UNITED
STATES


SECURITIES
AND EXCHANGE COMMISSION


WASHINGTON
D.C. 20549







FORM 10-Q





x
            
            QUARTERLY
      REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES
      EXCHANGE ACT OF 1934FOR
      THE QUARTERLY PERIOD ENDED SEPTEMBER 30, 2009ORo
            
            TRANSITION
      REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES
      EXCHANGE ACT OF 1934




FOR
THE TRANSITION PERIOD FROM
           TO
          .




COMMISSION
FILE NUMBER: 0-50295







ADVANCED
CELL TECHNOLOGY, INC.


(EXACT
NAME OF REGISTRANT AS SPECIFIED IN ITS CHARTER)




DELAWARE
            
            87-0656515(STATE
      OR OTHER JURISDICTION OF
            
            (I.R.S.
      EMPLOYER IDENTIFICATION NO.)INCORPORATION
      OR ORGANIZATION)




381
PLANTATION STREET, WORCESTER, MASSACHUSETTS 01605


(ADDRESS,
INCLUDING ZIP CODE, OF PRINCIPAL EXECUTIVE OFFICES)




REGISTRANT’S
TELEPHONE NUMBER, INCLUDING AREA CODE: (510) 748-4900




Indicate
by check mark whether the registrant (1) has filed all reports required to
be filed by Section 13 or 15(d) of the Securities Exchange Act of 1934
during the preceding 12 months (or for such shorter period that the registrant
was required to file such reports), and (2) has been subject to such filing
requirements for the past 90
days.      Yes   x
  No   o




Indicate
by check mark whether the registrant has submitted electronically and posted on
its corporate Web site, if any, every Interactive Data File required to be
submitted and posted pursuant to Rule 405 of Regulation S-T during the preceding
12 months (or for such shorter period that the registrant was required to submit
and post such files).  Yes o No o





Indicate
by check mark whether the registrant is a large accelerated filer, an
accelerated filer, a non-accelerated filer, or a smaller reporting company. See
definitions of “large accelerated filer,” “accelerated filer,” and “smaller
reporting company” in Rule 12b-2 of the Exchange Act. (Check
one):




Large
      accelerated filer o
            Accelerated
      filer  o
            Non-accelerated
      filer o
            Smaller reporting company 
      x(Do
      not check if a smaller
              reporting
      company)




Indicate
by check mark whether the registrant is a shell company (as defined in
Rule 12b-2 of the Exchange Act). Yes  o   No 
x




Indicate
the number of shares outstanding of each of the issuer’s classes of common
stock, as of the latest practicable date.




Class:
                
                Outstanding
      at November 12, 2009:Common
      Stock, $0.001 par value per share
                
                613,885,468 shares








ADVANCED
CELL TECHNOLOGY, INC. AND SUBSIDIARY





INDEX




PART I.
      FINANCIAL INFORMATIONITEM
      1. FINANCIAL STATEMENTS
              
              
              3ITEM
      2. MANAGEMENT’S DISCUSSION AND ANALYSIS OF FINANCIAL CONDITION AND RESULTS
      OF OPERATIONS
              
              
              34ITEM
      3. QUANTITATIVE AND QUALITATIVE DISCLOSURES ABOUT MARKET
    RISK
              
              
              57ITEM
      4. CONTROLS AND PROCEDURES
              
              
              58PART II.
      OTHER INFORMATIONITEM
      1. LEGAL PROCEEDINGS
              
              
              58ITEM
      2. UNREGISTERED SALES OF EQUITY SECURITIES AND USE OF
    PROCEEDS
              
              
              59ITEM
      3. DEFAULTS UPON SENIOR SECURITIES
              
              
              60ITEM
      4. SUBMISSION OF MATTERS TO A VOTE OF SECURITY HOLDERS
              
              
              60ITEM
      5. OTHER INFORMATION
              
              
              60ITEM
      6. EXHIBITS
              
              
              61SIGNATURE
              
              
              63


2





Part
I – FINANCIAL INFORMATION


Item 1. Financial
Statements





ADVANCED
CELL TECHNOLOGY, INC. AND SUBSIDIARY


CONSOLIDATED
BALANCE SHEETS


AS
OF SEPTEMBER 30, 2009 AND DECEMBER 31, 2008





September 30,
                                                    
                                                    
                                                    December 31,2009
                                                    
                                                    
                                                    2008(unaudited)ASSETSCURRENT
      ASSETS:Cash
      and cash equivalents
                                                    
                                                    $
                                                    1,057,758
                                                    
                                                    
                                                    $
                                                    816,904Accounts
      receivable
                                                    
                                                    
                                                    -
                                                    
                                                    
                                                    
                                                    261,504Prepaid
      expenses
                                                    
                                                    
                                                    55,466
                                                    
                                                    
                                                    
                                                    32,476Deposits
                                                    
                                                    
                                                    2,170
                                                    
                                                    
                                                    
                                                    -Deferred
      royalty fees, current portion
                                                    
                                                    
                                                    182,198
                                                    
                                                    
                                                    
                                                    182,198Total
      current assets
                                                    
                                                    
                                                    1,297,592
                                                    
                                                    
                                                    
                                                    1,293,082Property
      and equipment, net
                                                    
                                                    
                                                    182,055
                                                    
                                                    
                                                    
                                                    400,008Investment
      in joint venture
                                                    
                                                    
                                                    -
                                                    
                                                    
                                                    
                                                    225,200Deferred
      royalty fees, less current portion
                                                    
                                                    
                                                    522,840
                                                    
                                                    
                                                    
                                                    659,488Deferred
      issuance costs, net of amortization of $603,448 and
    $8,666,387
                                                    
                                                    
                                                    4,377,553
                                                    
                                                    
                                                    
                                                    -TOTAL
      ASSETS
                                                    
                                                    $
                                                    6,380,040
                                                    
                                                    
                                                    $
                                                    2,577,778LIABILITIES AND STOCKHOLDERS'
      DEFICITCURRENT
      LIABILITIES:Accounts
      payable
                                                    
                                                    $
                                                    6,835,891
                                                    
                                                    
                                                    $
                                                    8,287,786Accrued
      expenses
                                                    
                                                    
                                                    1,425,513
                                                    
                                                    
                                                    
                                                    2,741,591Accrued
      default interest
                                                    
                                                    
                                                    -
                                                    
                                                    
                                                    
                                                    3,717,384Deferred
      revenue, current portion
                                                    
                                                    
                                                    992,664
                                                    
                                                    
                                                    
                                                    834,578Advances
      payable, other
                                                    
                                                    
                                                    130,000
                                                    
                                                    
                                                    
                                                    130,0002005
      Convertible debenture and embedded derivatives, net of discounts of $0 and
      $0
                                                    
                                                    
                                                    -
                                                    
                                                    
                                                    
                                                    85,9972006
      Convertible debenture and embedded derivatives (fair value $0 and
      $1,993,354)
                                                    
                                                    
                                                    -
                                                    
                                                    
                                                    
                                                    1,993,3542007
      Convertible debenture and embedded derivatives (fair value $0 and
      $7,706,344)
                                                    
                                                    
                                                    -
                                                    
                                                    
                                                    
                                                    7,706,344February
      2008 Convertible promissory note and embedded derivatives (fair value $0
      and $1,757,470)
                                                    
                                                    
                                                    -
                                                    
                                                    
                                                    
                                                    1,757,470April
      2008 Convertible debenture and embedded derivatives (fair value $0 and
      $4,066,505)
                                                    
                                                    
                                                    -
                                                    
                                                    
                                                    
                                                    4,066,505Amended
      and restated convertible debentures, current portion, net of discounts of
      $1,240,575 and $0, respectively
                                                    
                                                    
                                                    12,849,395
                                                    
                                                    
                                                    
                                                    -Amended
      and restated convertible promissory note, current portion, net of
      discounts of $225,827 and $0, respectively
                                                    
                                                    
                                                    857,861
                                                    
                                                    
                                                    
                                                    -Warrant
      derivative liabilities
                                                    
                                                    
                                                    25,003,235
                                                    
                                                    
                                                    
                                                    2,655,849Embedded
      conversion option liabilities
                                                    
                                                    
                                                    17,605,348
                                                    
                                                    
                                                    
                                                    -Deferred
      joint venture obligations, current portion
                                                    
                                                    
                                                    94,412
                                                    
                                                    
                                                    
                                                    167,335Short
      term capital leases
                                                    
                                                    
                                                    12,955
                                                    
                                                    
                                                    
                                                    12,955Notes
      payable, other
                                                    
                                                    
                                                    468,425
                                                    
                                                    
                                                    
                                                    468,425Total
      current liabilities
                                                    
                                                    
                                                    66,275,699
                                                    
                                                    
                                                    
                                                    34,625,573Amended
      and restated debentures, less current portion, net of discounts of
      $283,465 and $0, respectively
                                                    
                                                    
                                                    2,936,018
                                                    
                                                    
                                                    
                                                    -Deferred
      joint venture obligations, less current portion
                                                    
                                                    
                                                    11,232
                                                    
                                                    
                                                    
                                                    63,473Deferred
      revenue, less current portion
                                                    
                                                    
                                                    5,924,518
                                                    
                                                    
                                                    
                                                    3,817,716Total
      liabilities
                                                    
                                                    
                                                    75,147,467
                                                    
                                                    
                                                    
                                                    38,506,762Series
      A-1 Convertible Preferred Stock, $0.001 par value; 50,000,000 shares
      authorized,229
      and 0 shares issued and outstanding; aggregate liquidation value, net of
      discounts: $2,372,209 and $0, respectively
                                                    
                                                    
                                                    2,050,471
                                                    
                                                    
                                                    
                                                    -Commitments
      and contingencies
                                                    
                                                    
                                                    -
                                                    
                                                    
                                                    
                                                    -STOCKHOLDERS'
      DEFICIT:Common
      stock, $0.001par value; 1,750,000,000 shares authorized,547,964,766
      and 429,448,381 issued and outstanding
                                                    
                                                    
                                                    547,964
                                                    
                                                    
                                                    
                                                    429,448Additional
      paid-in capital
                                                    
                                                    
                                                    68,092,696
                                                    
                                                    
                                                    
                                                    53,459,172Accumulated
      deficit
                                                    
                                                    
                                                    (139,458,558
                                                    )
                                                    
                                                    
                                                    (89,817,604
                                                    )Total
      stockholders' deficit
                                                    
                                                    
                                                    (70,817,898
                                                    )
                                                    
                                                    
                                                    (35,928,984
                                                    )TOTAL
      LIABILITIES AND STOCKHOLDERS' DEFICIT
                                                    
                                                    $
                                                    6,380,040
                                                    
                                                    
                                                    $
                                                    2,577,778





The
accompanying notes are an integral part of these consolidated financial
statements.


3





ADVANCED
CELL TECHNOLOGY, INC. AND SUBSIDIARY


CONSOLIDATED
STATEMENTS OF OPERATIONS


FOR
THE THREE AND NINE MONTHS ENDED SEPTEMBER 30, 2009 AND 2008


(UNAUDITED)




Three
      Months Ended September 30,
                            
                            
                            Nine
      Months Ended September 30,2009
                            
                            
                            2008
                            
                            
                            2009
                            
                            
                            2008Revenue(License fees
      and royalties)
                            
                            $
                            248,141
                            
                            
                            $
                            242,195
                            
                            
                            $
                            785,112
                            
                            
                            $
                            540,926Cost
      of Revenue
                            
                            
                            108,049
                            
                            
                            
                            95,180
                            
                            
                            
                            324,148
                            
                            
                            
                            406,094Gross
      profit
                            
                            
                            140,092
                            
                            
                            
                            147,015
                            
                            
                            
                            460,964
                            
                            
                            
                            134,832Operating
      expenses:Research
      and development
                            
                            
                            700,818
                            
                            
                            
                            1,434,896
                            
                            
                            
                            2,275,683
                            
                            
                            
                            8,189,318Grant
      reimbursements
                            
                            
                            -
                            
                            
                            
                            -
                            
                            
                            
                            (136,840
                            )
                            
                            
                            (105,169
                            )General
      and administrative expenses
                            
                            
                            453,561
                            
                            
                            
                            594,663
                            
                            
                            
                            1,961,195
                            
                            
                            
                            4,160,601Loss
      on settlement of litigation
                            
                            
                            110,000
                            
                            
                            
                            740,849
                            
                            
                            
                            4,903,949
                            
                            
                            
                            740,849Total
      operating expenses
                            
                            
                            1,264,379
                            
                            
                            
                            2,770,408
                            
                            
                            
                            9,003,987
                            
                            
                            
                            12,985,599Loss
      from operations
                            
                            
                            (1,124,287
                            )
                            
                            
                            (2,623,393
                            )
                            
                            
                            (8,543,023
                            )
                            
                            
                            (12,850,767
                            )Non-operating
      income (expense):Interest
      income
                            
                            
                            371
                            
                            
                            
                            70
                            
                            
                            
                            2,129
                            
                            
                            
                            8,236Interest
      expense and late fees
                            
                            
                            (2,354,537
                            )
                            
                            
                            (13,740,858
                            )
                            
                            
                            (3,890,447
                            )
                            
                            
                            (26,488,148
                            )Charges
      related to issuance of 2008 convertible debentures
                            
                            
                            -
                            
                            
                            
                            -
                            
                            
                            
                            -
                            
                            
                            
                            (1,217,342
                            )Income
      related to repricing of 2006 and 2007 convertible debentures and
      warrants
                            
                            
                            -
                            
                            
                            
                            -
                            
                            
                            
                            -
                            
                            
                            
                            847,588Adjustments
      to fair value of derivatives
                            
                            
                            36,754,306
                            
                            
                            
                            3,762,539
                            
                            
                            
                            (788,680
                            )
                            
                            
                            11,989,715Losses
      attributable to equity method investment
                            
                            
                            -
                            
                            
                            
                            -
                            
                            
                            
                            (144,438
                            )
                            
                            
                            -Loss
      on extinguishment of convertible debentures and note
                            
                            
                            (34,480,127
                            )
                            
                            
                            -
                            
                            
                            
                            (36,276,495
                            )
                            
                            
                            -Total
      non-operating income (expense)
                            
                            
                            (79,987
                            )
                            
                            
                            (9,978,249
                            )
                            
                            
                            (41,097,931
                            )
                            
                            
                            (14,859,951
                            )Loss
      before income tax
                            
                            
                            (1,204,274
                            )
                            
                            
                            (12,601,642
                            )
                            
                            
                            (49,640,954
                            )
                            
                            
                            (27,710,718
                            )Income
      tax
                            
                            
                            -
                            
                            
                            
                            -
                            
                            
                            
                            -
                            
                            
                            
                            -Net
      loss
                            
                            $
                            (1,204,274
                            )
                            
                            $
                            (12,601,642
                            )
                            
                            $
                            (49,640,954
                            )
                            
                            $
                            (27,710,718
                            )Weighted
      average shares outstanding :Basic
                            
                            
                            501,293,320
                            
                            
                            
                            194,417,191
                            
                            
                            
                            477,394,516
                            
                            
                            
                            148,070,055Diluted
                            
                            
                            501,293,320
                            
                            
                            
                            194,417,191
                            
                            
                            
                            477,394,516
                            
                            
                            
                            148,070,055Loss
      per share:Basic
                            
                            $
                            (0.00
                            )
                            
                            $
                            (0.06
                            )
                            
                            $
                            (0.10
                            )
                            
                            $
                            (0.19
                            )Diluted
                            
                            $
                            (0.00
                            )
                            
                            $
                            (0.06
                            )
                            
                            $
                            (0.10
                            )
                            
                            $
                            (0.19
                            )





The
accompanying notes are an integral part of these consolidated financial
statements.


4





ADVANCED
CELL TECHNOLOGY, INC. AND SUBSIDIARY


CONSOLIDATED
STATEMENT OF STOCKHOLDERS' DEFICIT


FOR
THE NINE MONTHS ENDED SEPTEMBER 30, 2009


(UNAUDITED)





Additional
                  
                  
                  
                  
                  
                  TotalCommon
      Stock
                  
                  
                  Paid-in
                  
                  
                  Accumulated
                  
                  
                  Stockholders'Shares
                  
                  
                  Amount
                  
                  
                  Capital
                  
                  
                  Deficit
                  
                  
                  DeficitBalance
      December 31, 2008
                  
                  
                  429,448,381
                  
                  
                  $
                  429,448
                  
                  
                  $
                  53,459,172
                  
                  
                  $
                  (89,817,604
                  )
                  
                  $
                  (35,928,984
                  )Convertible
      debentures redemptions
                  
                  
                  12,627,425
                  
                  
                  
                  12,627
                  
                  
                  
                  1,250,115
                  
                  
                  
                  
                  
                  
                  
                  1,262,742Convertible
      debenture and promissory note conversions
                  
                  
                  41,608,113
                  
                  
                  
                  41,608
                  
                  
                  
                  3,140,191
                  
                  
                  
                  
                  
                  
                  
                  3,181,799Option
      compensation charges
                  
                  
                  
                  
                  
                  
                  
                  
                  
                  
                  277,351
                  
                  
                  
                  
                  
                  
                  
                  277,351Issuance
      of stock in settlement of accounts payable
                  
                  
                  39,380,847
                  
                  
                  
                  39,381
                  
                  
                  
                  5,259,767
                  
                  
                  
                  
                  
                  
                  
                  5,299,148Issuance
      of stock in payment of debt issue costs for preferred stock credit
      facility
                  
                  
                  24,900,000
                  
                  
                  
                  24,900
                  
                  
                  
                  4,706,100
                  
                  
                  
                  
                  
                  
                  
                  4,731,000Net
      loss for the nine months ended September 30, 2009
                  
                  
                  
                  
                  
                  
                  
                  
                  
                  
                  
                  
                  
                  
                  (49,640,954
                  )
                  
                  
                  (49,640,954
                  )Balance
      September 30, 2009
                  
                  
                  547,964,766
                  
                  
                  $
                  547,964
                  
                  
                  $
                  68,092,696
                  
                  
                  $
                  (139,458,558
                  )
                  
                  $
                  (70,817,898
                  )





The
accompanying notes are an integral part of these consolidated financial
statements


5




ADVANCED
CELL TECHNOLOGY, INC. AND SUBSIDIARY


CONSOLIDATED
STATEMENTS OF CASH FLOWS


FOR
THE NINE MONTHS ENDED SEPTEMBER 30, 2009 AND 2008


(UNAUDITED)





Nine Months Ended September 30,2009
                                
                                
                                2008CASH
      FLOWS FROM OPERATING ACTIVITIES:Net
      loss
                                
                                $
                                (49,640,954
                                )
                                
                                $
                                (27,710,718
                                )Adjustments
      to reconcile net loss to net cashused
      in operating activities:Depreciation
      and amortization
                                
                                
                                304,083
                                
                                
                                
                                312,672Write-off
      of uncollectible accounts receivable
                                
                                
                                -
                                
                                
                                
                                25,000Amortization
      of deferred charges
                                
                                
                                136,648
                                
                                
                                
                                528,593Amortization
      of deferred revenue
                                
                                
                                (785,112
                                )
                                
                                
                                (553,355
                                )Redeemable
      preferred stock dividend accrual
                                
                                
                                84,209
                                
                                
                                
                                -Stock
      based compensation
                                
                                
                                277,351
                                
                                
                                
                                768,193Amortization
      of deferred issuance costs
                                
                                
                                603,447
                                
                                
                                
                                4,792,087Amortization
      of discounts
                                
                                
                                1,805,531
                                
                                
                                
                                17,458,660Loss
      on extinguishment of convertible debentures and note
                                
                                
                                36,276,495
                                
                                
                                
                                -Adjustments
      to fair value of derivatives
                                
                                
                                788,680
                                
                                
                                
                                (11,989,715
                                )Charges
      related to issuance of February 2008 convertible notes
                                
                                
                                -
                                
                                
                                
                                685,573Charges
      related to issuance of April 2008 convertible notes
                                
                                
                                -
                                
                                
                                
                                531,769Repricing
      of 2006 and 2007 convertible debentures and warrants
                                
                                
                                -
                                
                                
                                
                                (847,588
                                )Shares
      of common stock issued for services
                                
                                
                                -
                                
                                
                                
                                9,496Warrants
      issued for consulting services
                                
                                
                                -
                                
                                
                                
                                155,281Charges
      related to settlement of anti-dilution provision
                                
                                
                                -
                                
                                
                                
                                15,581Issuance
      of note for services received
                                
                                
                                -
                                
                                
                                
                                750,000Shares
      of common stock issued for financing costs
                                
                                
                                -
                                
                                
                                
                                697,834Non-cash
      rent expense
                                
                                
                                -
                                
                                
                                
                                254,231Forfeiture
      of rent deposits
                                
                                
                                -
                                
                                
                                
                                88,504Loss
      on settlement of litigation
                                
                                
                                4,903,949
                                
                                
                                
                                740,849Loss
      attributable to investment in joint venture
                                
                                
                                144,438
                                
                                
                                
                                -Amortization
      of deferred joint venture obligations
                                
                                
                                (125,164
                                )
                                
                                
                                -(Increase)
      / decrease in assets:Accounts
      receivable
                                
                                
                                261,504
                                
                                
                                
                                (4,767
                                )Prepaid
      expenses
                                
                                
                                (22,990
                                )
                                
                                
                                (1,626
                                )Increase
      / (decrease) in current liabilities:Accounts
      payable and accrued expenses
                                
                                
                                (2,433,053
                                )
                                
                                
                                5,065,128Accrued
      interest
                                
                                
                                1,311,330
                                
                                
                                
                                3,535,643Deferred
      revenue
                                
                                
                                3,050,000
                                
                                
                                
                                920,000Net
      cash used in operating activities
                                
                                
                                (3,059,608
                                )
                                
                                
                                (3,772,675
                                )CASH
      FLOWS FROM INVESTING ACTIVITIESPurchases
      of property and equipment
                                
                                
                                (5,368
                                )
                                
                                
                                (174,017
                                )Payment
      of deposits
                                
                                
                                (2,170
                                )
                                
                                
                                -Net
      cash used in investing activities
                                
                                
                                (7,538
                                )
                                
                                
                                (174,017
                                )CASH
      FLOWS FROM FINANCING ACTIVITIES:Proceeds
      from issuance of convertible notes
                                
                                
                                1,020,000
                                
                                
                                
                                2,182,432Payments
      on notes and leases
                                
                                
                                -
                                
                                
                                
                                (18,650
                                )Proceeds
      from notes payable
                                
                                
                                -
                                
                                
                                
                                630,000Payment
      for issuance costs on note payable
                                
                                
                                -
                                
                                
                                
                                (3,660
                                )Proceeds
      from issuance of Series A-1 convertible preferred stock
                                
                                
                                2,288,000
                                
                                
                                
                                -Net
      cash provided by financing activities
                                
                                
                                3,308,000
                                
                                
                                
                                2,790,122NET
      INCREASE (DECREASE) IN CASH AND CASH EQUIVALENTS
                                
                                
                                240,854
                                
                                
                                
                                (1,156,570
                                )CASH
      AND CASH EQUIVALENTS, BEGINNING BALANCE
                                
                                
                                816,904
                                
                                
                                
                                1,166,116CASH
      AND CASH EQUIVALENTS, ENDING BALANCE
                                
                                $
                                1,057,758
                                
                                
                                $
                                9,546CASH
      PAID FOR:Interest
                                
                                $
                                -
                                
                                
                                $
                                2,504Income
      taxes
                                
                                $
                                514
                                
                                
                                $
                                -SUPPLEMENTAL
      DISCLOSURE OF NON-CASH FINANCING ACTIVITIES:Issuance
      of 12,627,425 and 59,805,820 shares of common stock in redemption of
      convertible debentures
                                
                                $
                                1,262,742
                                
                                
                                $
                                5,307,226Issuance
      of 41,608,113 and 38,100,654 shares of common stock in conversion of
      convertible debentures
                                
                                $
                                3,181,799
                                
                                
                                $
                                5,915,442Issuance
      of 24,900,000 shares of common stock in payment convertible preferred
      stock issuance costs
                                
                                $
                                4,731,000
                                
                                
                                $
                                -Issuance
      of 39,380,847 shares of common stock in settlement of
      litigation
                                
                                $
                                5,299,148
                                
                                
                                $
                                -Issuance
      of 70,503 shares of common stock to settle an anti-dilution provision
      feature ofconvertible debenture
                                
                                $
                                -
                                
                                
                                $
                                15,581Issuance
      of 1,200,000 shares of common stock upon exercise of employee stock
      options
                                
                                $
                                -
                                
                                
                                $
                                60,000





The
accompanying notes are an integral part of these consolidated financial
statements.


6




ADVANCED
CELL TECHNOLOGY, INC. AND SUBSIDIARY
 NOTES
TO CONSOLIDATED FINANCIAL STATEMENTS
 September
30, 2009
  1.
        ORGANIZATIONAL
MATTERS
 
 Organization
and Nature of Business
  Advanced
Cell Technology, Inc. (the “Company”) is a biotechnology company, incorporated
in the state of Delaware, focused on developing and commercializing human
embryonic and adult stem cell technology in the emerging fields of regenerative
medicine. Principal activities to date have included obtaining financing,
securing operating facilities, and conducting research and development. The
Company has no therapeutic products currently available for sale and does not
expect to have any therapeutic products commercially available for sale for a
period of years, if at all. These factors indicate that the Company’s ability to
continue its research and development activities is dependent upon the ability
of management to obtain additional financing as required.
  Going
Concern
  As
reflected in the accompanying financial statements, the Company has losses from
operations, negative cash flows from operations, a substantial stockholders’
deficit and current liabilities exceed current assets. The Company may thus not
be able to continue as a going concern and fund cash requirements for operations
through the next 12 months with current cash reserves. As discussed below, the
Company was able to raise additional cash during the third quarter of
2009.  Notwithstanding success in raising capital, there continues to be
substantial doubt about the Company’s ability to continue as a going
concern.
  In view
of the matters described in the preceding paragraph, recoverability of a major
portion of the recorded asset amounts shown in the accompanying consolidated
balance sheet is dependent upon continued operations of the Company, which, in
turn, is dependent upon the Company’s ability to continue to raise capital and
ultimately generate positive cash flows from operations. The financial
statements do not include any adjustments relating to the recoverability and
classification of recorded asset amounts or amounts and classifications of
liabilities that might be necessary should the Company be unable to continue its
existence.
  Management
has taken or plans to take the following steps that it believes will be
sufficient to provide the Company with the ability to continue in
existence:
  ·
              On
      March 30, 2009, the Company entered into a license agreement with CHA Bio
      & Diostech Co., Ltd . (“CHA”) under which
      the Company will license its retinal pigment epithelium (“RPE”)
      technology, for the treatment of diseases of the eye, to CHA for
      development and commercialization exclusively in Korea. The Company is
      eligible to receive up to a total of $1.9 million in fees based upon the
      parties achieving certain milestones, including the Company making an IND
      submission to the US FDA to commence clinical trials in humans using the
      technology. The Company received an up-front fee under the license in the
      amount of $1,100,000 during the nine months ended September 30, 2009.
      Under the agreement, CHA will incur all of the costs associated with the
      RPA clinical trials in Korea. The agreement is part of continuing
      cooperation and collaboration between the two companies. See Note
      3.
 
 ·
              On
      March 11, 2009, the Company entered into a $5 million credit facility
      (“Facility”) with a life sciences fund. Under the terms of the agreement,
      the Company may draw down funds from the investor through the issuance of
      Series A-1 redeemable convertible preferred stock. The preferred stock
      pays dividends, in kind of preferred stock, at an annual rate of 10%,
      matures in four years from the initial issuance date, and is convertible
      anytime into common stock at $0.75 per share. As of November 3, 2009, the
      Company has drawn down approximately $2,288,000 on this facility. See Note
      10. On October 19, 2009, the Company entered into two letter agreements
      with Volation Life Sciences Capital Partners, LLC (“Volation”) (See Note
      10), pursuant to which (i) the Company reduced the conversion price of its
      outstanding Series A-1 convertible preferred stock issued to Volation to
      $.10 per share resulting in 22,880,000 shares of Common Stock upon
      conversion, (ii) issued Volation 2,500,000 shares of its Common Stock at
      $0.10 per share in payment of an outstanding commitment fee, and (iii)
      Volation waived the delinquency in  non-payment of the $250,000
      commitment fee required pursuant to the preferred stock purchase agreement
      between the Company and Volation.
  7
  ·
                On
      May 13, 2009, the Company entered into another license agreement with CHA
      under which the Company will license its proprietary “single blastomere
      technology,” which has the potential to generate stable cell lines,
      including RPE for the treatment of diseases of the eye, for development
      and commercialization exclusively in Korea. The Company received an
      upfront license fee of $300,000. See Note
3.
 
 ·
                On
      July 29, 2009, the Company entered into a consent, amendment and exchange
      agreement with holders of the Company’s outstanding convertible debentures
      and warrants, which were issued in private placements to the 2005, 2006,
      2007 and 2008 debentures. The Company agreed to issue to each debenture
      holder in exchange for the holder’s debenture an amended and restated
      debenture in a principal amount equal to the principal amount of the
      holder’s debenture times 1.35 minus any interest paid thereon. The
      conversion price under the amended and restated debentures was reduced to
      $0.10, subject to certain customary anti-dilution adjustments. The
      maturity date under the amended and restated debentures was extended until
      December 30, 2010. The amended and restated debentures bear interest at
      12% per annum. Further, the Company agreed to issue to each holder in
      exchange for the holder’s warrants amended and restated warrants, as well
      as additional warrants exercisable into 79,076,873 shares of the Company’s
      common stock for a total of warrants exercisable into 192,172,519 shares
      of common stock, both warrants containing a reduced exercise price of
      $0.10, subject to certain customary anti-dilution adjustments. The
      termination date under the amended and restated warrants was extended
      until June 30, 2014. Simultaneously with the signing of this agreement,
      the Company and the debenture holders entered into a standstill and
      forbearance agreement, whereby the debenture holders agreed to forbear
      from exercising their rights and remedies under the original debentures
      and transaction documents.
 
 ·
                During
      September 2009, the Company received $1,020,000 under its convertible
      promissory notes with JMJ Financial, originally executed on February 14,
      2008. See Note 6.·
                See
      Note 16 “Subsequent Events” for additional financing procured through
      November 16, 2009.
 ·
                Management
      anticipates raising additional future capital from its current convertible
      debenture holders, or other financing sources, that will be used to fund
      any capital shortfalls. The terms of any financing will likely be
      negotiated based upon current market terms for similar financings. No
      commitments have been received for additional investment and no assurances
      can be given that this financing will ultimately be
    completed.
  ·
                Management
      has focused its scientific operations on product development in order to
      accelerate the time to market products which will ultimately generate
      revenues. While the amount or timing of such revenues cannot be
      determined, management believes that focused development will ultimately
      provide a quicker path to revenues, and an increased likelihood of raising
      additional financing.
 
 ·
                Management
      will continue to pursue licensing opportunities of the Company’s extensive
      intellectual property
portfolio.
  8
  2.           SUMMARY
OF SIGNIFICANT ACCOUNTING POLICIES
  Basis of
Presentation —The Company follows accounting standards set by the
Financial Accounting Standards Board (“FASB”). The accompanying consolidated
financial statements have been prepared in accordance with accounting principles
generally accepted in the United States of America (“GAAP”). References to GAAP
issued by the FASB in these footnotes are to the FASB Accounting Standards
Codification,TM sometimes referred to as the Codification or ASC. The FASB
finalized the Codification effective for periods ending on or after September
15, 2009. Prior FASB standards are no longer being issued by the
FASB.
 
 The
accompanying consolidated unaudited financials statements of the Company have
been prepared in accordance with accounting principles generally accepted in the
United States of America for interim financial statements and with instructions
to Form 10-Q pursuant to the rules and regulations of Securities and Exchange
Act of 1934 (the “Exchange Act”) and Article 8-03 if Regulation S-X under the
Exchange Act. Accordingly, they do not include all of the information and
footnotes required by GAAP for complete financial statements. In the opinion of
management, all adjustments considered necessary (consisting of normal recurring
adjustments) for a fair presentation are included herein. Operating results for
the three and nine months ended September 30, 2009 are not indicative of the
results that may be expected for the fiscal year ending December 31, 2009. These
unaudited consolidated financial statements should be read in conjunction with
the audited financial statements and the notes thereto included in the Company’s
annual report on Form 10-K for the year ended December 31, 2008.
  Principles of
Consolidation —The accounts of the Company and its wholly-owned
subsidiary Mytogen, Inc. (“Mytogen”) are included in the accompanying
consolidated financial statements. All intercompany balances and transactions
were eliminated in consolidation.
 
 Segment
Reporting —FASB ASC 280, “Segment Reporting” requires
use of the “management approach” model for segment reporting. The management
approach model is based on the way a company’s management organizes segments
within the company for making operating decisions and assessing performance. The
Company determined it has one operating segment. Disaggregation of the Company’s
operating results is impracticable, because the Company’s research and
development activities and its assets overlap, and management reviews its
business as a single operating segment. Thus, discrete financial information is
not available by more than one operating segment.
  Use of
Estimates —These consolidated financial statements have been prepared in
accordance with accounting principles generally accepted in the United States
and, accordingly, require management to make estimates and assumptions that
affect the reported amounts of assets and liabilities at the date of the
financial statements and the reported amounts of revenues and expenses during
the reporting period. Specifically, the Company’s management has estimated
variables used to calculate the Black-Scholes option pricing model used to value
derivative instruments as discussed below under “Fair Value Measurements”. In
addition, management has estimated the expected economic life and value of the
Company’s licensed technology, the Company’s net operating loss for tax
purposes, share-based payments for compensation to employees, directors,
consultants and investment banks, and the useful lives of the Company’s fixed
assets and its accounts receivable allowance. Actual results could differ from
those estimates.
  Reclassifications
—Certain prior year financial statement balances have been reclassified to
conform to the current year presentation. These reclassifications had no effect
on the recorded net loss.
  Cash and Cash
Equivalents —Cash equivalents are comprised of certain highly liquid
investments with maturities of three months or less when purchased. The Company
maintains its cash in bank deposit accounts, which at times, may exceed
federally insured limits. The Company has not experienced any losses related to
this concentration of risk. As of September 30, 2009 and December 31, 2008, the
Company had deposits in excess of federally-insured limits totaling $589,077 and
$655,074, respectively.
 
 9
  Accounts
Receivable —The Company periodically assesses its accounts receivable for
collectability on a specific identification basis. Past due status on accounts
receivable is based on contractual terms. If collectability of an account
becomes unlikely, the Company records an allowance for that doubtful account.
Once the Company has exhausted efforts to collect, management writes off the
account receivable against the allowance it has already created. The Company
does not require collateral for its trade accounts receivable.
  Property and
Equipment — The Company records its property and equipment at historical
cost. The Company expenses maintenance and repairs as incurred. Upon disposition
of property and equipment, the gross cost and accumulated depreciation are
written off and the difference between the proceeds and the net book value is
recorded as a gain or loss on sale of assets. In the case of certain assets
acquired under capital leases, the assets are recorded net of imputed interest,
based upon the net present value of future payments. Assets under capital lease
are pledged as collateral for the related lease.
 
 The
Company provides for depreciation over the assets’ estimated useful lives as
follows:
 
 Machinery
      & equipment
              
              4
      yearsComputer
      equipment
              
              3
      yearsOffice
      furniture
              
              4
      yearsLeasehold
      improvements
              
              Lesser
      of lease life or economic lifeCapital
      leases
              
              Lesser
      of lease life or economic life
 
 Equity Method
Investment — The Company follows FASB ASC 323 “Investments-Equity Method and Joint
Ventures”in accounting for its investment in the joint venture. In the
event the Company’s share of the joint venture’s net losses reduces the
Company’s investment to zero, the Company will discontinue applying the equity
method and will not provide for additional losses unless the Company has
guaranteed obligations of the joint venture or is otherwise committed to provide
further financial support for the joint venture. If the joint venture
subsequently reports net income, the Company will resume applying the equity
method only after its share of that net income equals the share of net losses
not recognized during the period the equity method was suspended.
  Deferred Issuance
Costs —Payments, either in cash or share-based payments, made in
connection with the sale of debentures are recorded as deferred debt issuance
costs and amortized using the effective interest method over the lives of the
related debentures. The weighted average amortization period for deferred debt
issuance costs is 48 months.
  Intangible and
Long-Lived Assets — The Company follows FASB ASC 360-10, “Property, Plant, and Equipment,”which established a “primary asset” approach to determine the cash flow
estimation period for a group of assets and liabilities that represents the unit
of accounting for a long-lived asset to be held and used. Long-lived assets to
be held and used are reviewed for impairment whenever events or changes in
circumstances indicate that the carrying amount of an asset may not be
recoverable. The carrying amount of a long-lived asset is not recoverable if it
exceeds the sum of the undiscounted cash flows expected to result from the use
and eventual disposition of the asset. Long-lived assets to be disposed of are
reported at the lower of carrying amount or fair value less cost to sell.
Through September 30, 2009, the Company had not experienced impairment losses on
its long-lived assets.
  Fair Value
Measurements — For certain financial instruments, including accounts
receivable, accounts payable, accrued expenses, interest payable, advances
payable and notes payable, the carrying amounts approximate fair value due to
their relatively short maturities.
 
 On
January 1, 2008, the Company adopted FASB ASC 820-10, “Fair Value Measurements and
Disclosures.” FASB ASC 820-10 defines fair value, and establishes a
three-level valuation hierarchy for disclosures of fair value measurement that
enhances disclosure requirements for fair value measures. The carrying amounts
reported in the consolidated balance sheets for receivables and current
liabilities each qualify as financial instruments and are a reasonable estimate
of their fair values because of the short period of time between the origination
of such instruments and their expected realization and their current market rate
of interest. The three levels of valuation hierarchy are defined as
follows:
  10
  ·
              Level
      1 inputs to the valuation methodology are quoted prices for identical
      assets or liabilities in active
markets.
 
 ·
              Level
      2 inputs to the valuation methodology include quoted prices for similar
      assets and liabilities in active markets, and inputs that are observable
      for the asset or liability, either directly or indirectly, for
      substantially the full term of the financial
  instrument.
 
 ·
              Level
      3 inputs to the valuation methodology are unobservable and significant to
      the fair value measurement.
 
 The
Company analyzes all financial instruments with features of both liabilities and
equity under FASB ASC 480, “Distinguishing Liabilities From
Equity”and FASB ASC 815, “Derivatives and Hedging.”
Derivative liabilities are adjusted to reflect fair value at each period end,
with any increase or decrease in the fair value being recorded in results of
operations as adjustments to fair value of derivatives. The effects of
interactions between embedded derivatives are calculated and accounted for in
arriving at the overall fair value of the financial instruments. In addition,
the fair values of freestanding derivative instruments such as warrant and
option derivatives are valued using the Black-Scholes model.
  The
Company’s warrant derivative liabilities are carried at fair value totaling
$25,003,235 and $2,655,849, as of September 30, 2009 and December 31, 2008,
respectively.  The Company’s embedded conversion option liabilities
are carried at fair value totaling $17,605,348 and $1,842,976 as of September
30, 2009 and December 31, 2008, respectively.  The Company used Level
2 inputs for its valuation methodology for the warrant derivative liabilities
and embedded conversion option liabilities as their fair values were determined
by using the Black-Scholes option pricing model based on various assumptions.
The Company’s derivative liabilities are adjusted to reflect fair value at each
period end, with any increase or decrease in the fair value being recorded in
results of operations as adjustments to fair value of derivatives.
 
 At
September 30, 2009, the Company identified the following assets and liabilities
that are required to be presented on the balance sheet at fair
value:
 
 Fair Value Measurements atFair Value
                                                            
                                                            
                                                            September 30, 2009As of
                                                            
                                                            
                                                            Using Fair Value HierarchyDerivative Liabilities
                                                            
                                                            September 30, 2009
                                                            
                                                            
                                                            Level
      1
                                                            
                                                            
                                                            Level
      2
                                                            
                                                            
                                                            Level
      3Warrant
      derivative liabilities
                                                            
                                                            $
                                                            25,003,235
                                                            
                                                            
                                                            $
                                                            -
                                                            
                                                            
                                                            
                                                            25,003,235
                                                            
                                                            
                                                            
                                                            -Embedded
      conversion option liabilities
                                                            
                                                            
                                                            17,605,348
                                                            
                                                            
                                                            
                                                            -
                                                            
                                                            
                                                            
                                                            17,605,348
                                                            
                                                            
                                                            
                                                            -$
                                                            42,608,583
                                                            
                                                            
                                                            $
                                                            -
                                                            
                                                            
                                                            
                                                            42,608,583
                                                            
                                                            
                                                            
                                                            -
  For the
three months ended September 30, 2009 and 2008, the Company recognized a gain of
$36,754,306 and $3,762,539, respectively, for the changes in the valuation of
the aforementioned liabilities. For the nine months ended September 30, 2009 and
2008, the Company recognized a gain (loss) of ($788,680) and $11,989,715,
respectively, for the changes in the valuation of the aforementioned
liabilities.
 
 The
Company did not identify any other non-recurring assets and liabilities that are
required to be presented in the consolidated balance sheets at fair value in
accordance with FASB ASC 815.
 
 In
February 2007, the FASB issued FAS No. 159, “The Fair Value Option for Financial
Assets and Financial Liabilities,”now known as ASC Topic 825-10 “Financial Instruments.” ASC
Topic 825-10 permits entities to choose to measure many financial assets and
financial liabilities at fair value. Unrealized gains and losses on items for
which the fair value option has been elected are reported in earnings. FASB ASC
825-10 is effective as of the beginning of an entity’s first fiscal year that
begins after November 15, 2007. The Company adopted FASB ASC 825-10 on January
1, 2008. The Company chose not to elect the option to measure the fair value of
eligible financial assets and liabilities.
 
 11
  Revenue
Recognition — The Company’s revenues are generated from license and
research agreements with collaborators. Licensing revenue is recognized on a
straight-line basis over the shorter of the life of the license or the estimated
economic life of the patents related to the license. License fee revenue begins
to be recognized in the first full month following the effective date of the
license agreement. Deferred revenue represents the portion of the license and
other payments received that has not been earned. Costs associated with the
license revenue are deferred and recognized over the same term as the revenue.
Reimbursements of research expense pursuant to grants are recorded in the period
during which collection of the reimbursement becomes assured, because the
reimbursements are subject to approval.
  Research and
Development Costs —Research and development costs consist of expenditures
for the research and development of patents and technology, which cannot be
capitalized. The Company’s research and development costs consist mainly of
payroll and payroll related expenses, research supplies and research grants.
Reimbursements of research expense pursuant to grants are recorded in the period
during which collection of the reimbursement becomes assured, because the
reimbursements are subject to approval. Research and development costs are
expensed as incurred.
  Share-Based
Compensation —Effective January 1, 2006, the Company adopted the
fair value recognition provisions of FASB ASC 718 “Compensation-Stock
Compensation,” using the modified-prospective transition method. Under
this method, stock-based compensation expense is recognized in the consolidated
financial statements for stock options granted, modified or settled after the
adoption date. In accordance with FASB ASC 718, the unamortized portion of
options granted prior to the adoption date is recognized into earnings after
adoption. Results for prior periods have not been restated, as provided for
under the modified-prospective method.
  Under
FASB ASC 718, stock-based compensation expense recognized is based on the value
of the portion of share-based payment awards that are ultimately expected to
vest during the period. Based on this, our stock-based compensation is reduced
for estimated forfeitures at the time of grant and revised, if necessary, in
subsequent periods if actual forfeitures differ from those
estimates.
 
 The fair
value of each stock option is estimated on the date of grant using the
Black-Scholes option pricing model. No options were granted during the nine
months ended September 30, 2009.
 
 Assumptions
used in the Black-Scholes models are based upon the following data: (1) The
expected life of the option, estimated by considering the contractual term of
the option, the vesting period of the option, the employees’ expected exercise
behavior and the post-vesting employee turnover rate. (2) The expected
stock price volatility of the underlying shares over the expected term of the
option, based upon historical share price data. (3) The risk free interest
rate, based on published U.S. Treasury Department interest rates for the
expected terms of the underlying options. (4) Expected dividends, based on
historical dividend data and expected future dividend activity. (5) The
expected forfeiture rate, based on historical forfeiture activity and
assumptions regarding future forfeitures based on the composition of current
grantees.
  In
accordance with FASB ASC 718, the benefits of tax deductions in excess of the
compensation cost recognized for options exercised during the period are
classified as financing cash inflows rather than operating cash
inflows.
  Income
Taxes — Deferred income taxes are provided using the liability method
whereby deferred tax assets are recognized for deductible temporary differences
and operating loss and tax credit carryforwards, and deferred tax liabilities
are recognized for taxable temporary differences. Temporary differences are the
differences between the reported amounts of assets and liabilities and their tax
bases. Deferred tax assets are reduced by a valuation allowance when, in the
opinion of management, it is more likely than not that some portion or all of
the deferred tax assets will not be realized. Deferred tax assets and
liabilities are adjusted for the effects of the changes in tax laws and rates of
the date of enactment.
  12
  When tax
returns are filed, it is highly certain that some positions taken would be
sustained upon examination by the taxing authorities, while others are subject
to uncertainty about the merits of the position taken or the amount of the
position that would be ultimately sustained. The benefit of a tax position is
recognized in the financial statements in the period during which, based on all
available evidence, management believes it is more likely than not that the
position will be sustained upon examination, including the resolution of appeals
or litigation processes, if any. Tax positions taken are not offset or
aggregated with other positions. Tax positions that meet the
more-likely-than-not recognition threshold are measured as the largest amount of
tax benefit that is more than 50 percent likely of being realized upon
settlement with the applicable taxing authority. The portion of the benefits
associated with tax positions taken that exceeds the amount measured as
described above is reflected as a liability for unrecognized tax benefits in the
accompanying balance sheets along with any associated interest and penalties
that would be payable to the taxing authorities upon examination.
 
 Applicable
interest and penalties associated with unrecognized tax benefits are classified
as additional income taxes in the statements of operations.
  Net Loss Per
Share —   Earnings per share is calculated in accordance with the
FASB ASC 260-10, “Earnings Per
Share.” Basic earnings per share is based upon the weighted average
number of common shares outstanding. Diluted earnings per share is based on the
assumption that all dilutive convertible shares and stock options were converted
or exercised. Dilution is computed by applying the treasury stock method. Under
this method, options and warrants are assumed to be exercised at the beginning
of the period (or at the time of issuance, if later), and as if funds obtained
thereby were used to purchase common stock at the average market price during
the period.
 
 At
September 30, 2009 and 2008, approximately 406,476,000 and 222,302,000
potentially dilutive shares, respectively, were excluded from the shares used to
calculate diluted earnings per share as their inclusion would be
anti-dilutive.
  Concentrations
and Other Risks —Currently, the Company’s revenues and accounts
receivable are concentrated on a small number of customers. The following table
shows the Company’s concentrations of its revenue for those customers comprising
greater than 10% of total license revenue for the three and nine months ended
September 30, 2009 and 2008.
 
 3
      Months Ended
                    
                    
                    9
      Months EndedSeptember
      30,
                    
                    
                    September
      30,2009
                    
                    
                    2008
                    
                    
                    2009
                    
                    
                    2008Genzyme
      Transgenics Corporation
                    
                    
                    13%
                    
                    
                    
                    13%
                    
                    
                    
                    12%
                    
                    
                    
                    18%Exeter
      Life Sciences, Inc.
                    
                    
                    12%
                    
                    
                    
                    13%
                    
                    
                    
                    12%
                    
                    
                    
                    17%Start
      Licensing, Inc.
                    
                    
                    10%
                    
                    
                    
                    10%
                    
                    
                    
                    10%
                    
                    
                    
                    14%Terumo
      Corporation
                    
                    
                    **
                    
                    
                    
                    31%
                    
                    
                    
                    13%
                    
                    
                    
                    23%International
      Stem Cell Corporation
                    
                    
                    15%
                    
                    
                    
                    15%
                    
                    
                    
                    *
                    
                    
                    
                    *Transition
      Holdings, Inc.
                    
                    
                    21%
                    
                    
                    
                    **
                    
                    
                    
                    19%
                    
                    
                    
                    **CHA
      Biotech Co., Ltd.
                    
                    
                    11%
                    
                    
                    
                    **
                    
                    
                    
                    *
                    
                    
                    
                    **
 
 *License
revenue earned during the period was less than 10% of total license
revenue.
 **No
license revenue earned from this customer during the period.
 
 Other
risks include the uncertainty of the regulatory environment and the effect of
future regulations on the Company’s business activities. As the Company is a
biotechnology research and development company, there is also the attendant risk
that someone could commence legal proceedings over the Company’s discoveries.
Acts of God could also adversely affect the Company’s business.
  13
  Recent
Accounting Pronouncements
 
 In May
2009, the FASB issued SFAS No. 165, “Subsequent Events” (“SFAS
165”) codified in FASB ASC 855-10-05, which provides guidance to establish
general standards of accounting for and disclosures of events that occur after
the balance sheet date but before financial statements are issued or are
available to be issued. FASB ASC 855-10-05 also requires entities to disclose
the date through which subsequent events were evaluated as well as the rationale
for why that date was selected. FASB ASC 855-10-05 is effective for interim and
annual periods ending after June 15, 2009, and accordingly, the Company adopted
this pronouncement during the second quarter of 2009. FASB ASC 855-10-05
requires that public entities evaluate subsequent events through the date that
the financial statements are issued.
  In June
2009, the FASB issued SFAS No. 166, “Accounting for Transfers of
Financial Assets — an amendment of FASB Statement No. 140” (“SFAS 166”),
codified as FASB ASC 860, which requires entities to provide more information
regarding sales of securitized financial assets and similar transactions,
particularly if the entity has continuing exposure to the risks related to
transferred financial assets. FASB ASC 860 eliminates the concept of a
“qualifying special-purpose entity,” changes the requirements for derecognizing
financial assets and requires additional disclosures. FASB ASC 860 is effective
for fiscal years beginning after November 15, 2009. The adoption of FASB ASC 860
did not have an impact on the Company’s financial condition, results of
operations or cash flows.
 
 In June
2009, the FASB issued SFAS No. 167, “Amendments to FASB Interpretation
No. 46(R)” (“SFAS 167”), codified as FASB ASC 810-10, which modifies how
a company determines when an entity that is insufficiently capitalized or is not
controlled through voting (or similar rights) should be consolidated. FASB ASC
810-10 clarifies that the determination of whether a company is required to
consolidate an entity is based on, among other things, an entity’s purpose and
design and a company’s ability to direct the activities of the entity that most
significantly impact the entity’s economic performance. FASB ASC 810-10 requires
an ongoing reassessment of whether a company is the primary beneficiary of a
variable interest entity. FASB ASC 810-10 also requires additional disclosures
about a company’s involvement in variable interest entities and any significant
changes in risk exposure due to that involvement. FASB ASC 810-10 is effective
for fiscal years beginning after November 15, 2009. The adoption of FASB ASC
810-10 did not have an impact on the Company’s financial condition, results of
operations or cash flows.
 
 In June
2009, the FASB issued FASB ASC 105, Generally Accepted Accounting Principles,
which establishes the FASB Accounting Standards Codification as the sole source
of authoritative generally accepted accounting principles. Pursuant to the
provisions of FASB ASC 105, the Company has updated references to GAAP in its
financial statements issued for the period ended September 30, 2009. The
adoption of FASB ASC 105 did not impact the Company’s financial position or
results of operations.
 
 3.           LICENSE
REVENUE
 
 In
connection with the joint venture agreement discussed in Note 4, on December 1,
2008, the Company entered into a license agreement with CHA Bio & Diostech
Co., Ltd., a leading Korean-based biotechnology company focused on the
development of stem cell technologies, for the exclusive, worldwide license to
the Hemangioblast Program. Under the agreement, CHA agreed to acquire the
Company’s core technology for an up-front payment of $500,000 in cash. The
Company received $250,000 in December 2008 and the remaining $250,000 in January
2009. The Company has recorded $7,353 and $22,059 in license fee revenue for the
three and nine months ended September 30, 2009, respectively, in its
accompanying consolidated statements of operations, and the remainder of the
license fee has been accrued in deferred revenue at September 30, 2009. The
Company is recognizing revenue from this agreement over its 17-year patent
useful life.
 
 On
December 18, 2008, the Company entered into a license agreement with Transition
for certain of its non-core technology. Under the agreement, Transition agreed
to acquire a license to the technology for $3.5 million in cash. The Company
received $2,000,000 during December 2008 and the remaining $1,500,000 during the
nine months ended September 30, 2009. The Company expects to apply the proceeds
towards its retinal epithelium (“RPE”) cells program. The Company has recorded
$51,470 and $147,058 in license fee revenue for the three and nine months ended
September 30, 2009 in its accompanying consolidated statements of operations,
and the remainder of the license fee has been accrued in deferred revenue at
September 30, 2009. The Company is recognizing revenue from this agreement over
its 17-year patent useful life.
 
 14
  On March
30, 2009, the Company entered into a second license agreement with CHA under
which the Company will license its RPE technology, for the treatment of diseases
of the eye, to CHA for development and commercialization exclusively in Korea.
The Company is eligible to receive up to a total of $1.9 million in fees based
upon the parties achieving certain milestones, including the Company making an
IND submission to the US FDA to commence clinical trials in humans using the
technology. The Company received an up-front fee under the license in the amount
of $1,100,000 during the second quarter of 2009. Under the agreement, CHA will
incur all of the costs associated with the RPA clinical trials in Korea. The
Company has recorded $16,176 and $32,353 in license fee revenue for the three
and nine months ended September 30, 2009, respectively, in its accompanying
consolidated statements of operations, and the remainder of the license fee has
been accrued in deferred revenue at September 30, 2009. The Company is
recognizing revenue from this agreement over its 17-year patent useful
life.
 
 On May
13, 2009, the Company entered into a third license agreement with CHA under
which the Company will license its proprietary “single blastomere technology,”
which has the potential to generate stable cell lines, including RPE for the
treatment of diseases of the eye, for development and commercialization
exclusively in Korea. The Company received an upfront license fee of $300,000 on
May 8, 2009. The Company has recorded $4,412 and $5,882 in license fee revenue
for the three and nine months ended September 30, 2009, respectively, in its
accompanying consolidated statements of operations, and the remainder of the
license fee has been accrued in deferred revenue at September 30, 2009. The
Company is recognizing revenue from this agreement over its 17-year patent
useful life.
 
 4.           INVESTMENT
IN JOINT VENTURE
 
 On
December 1, 2008, the Company and CHA Bio & Diostech Co., Ltd. formed an
international joint venture. The new company, Stem Cell & Regenerative
Medicine International, Inc. (“SCRMI”), will develop human blood cells and other
clinical therapies based on the Company’s hemangioblast program, one of the
Company’s core technologies. Under the terms of the agreement, the Company
purchased upfront a 33% interest in the joint venture, and will receive another
7% interest upon fulfilling certain obligations under the agreement over a
period of 3 years. The Company’s contribution includes (a) the uninterrupted use
of a portion of its leased facility at the Company’s expense, (b) the
uninterrupted use of certain equipment in the leased facility, and (c) the
release of certain of the Company’s research and science personnel to be
employed by the joint venture. In return, for a 67% interest, CHA has agreed to
contribute $150,000 cash and to fund all operational costs in order to conduct
the hemangioblast program.
 
 The
Company has agreed to collaborate with the joint venture in securing grants to
further research and development of its technology. Additionally, SCRMI has
agreed to pay the Company a fee of $500,000 for an exclusive, worldwide license
to the Hemangioblast Program. The Company has recorded $7,353 and $22,059 in
license fee revenue for the three and nine months ended September 30, 2009 in
its accompanying consolidated statements of operations, and the balance of
unamortized license fee of $476,716 has been accrued in deferred revenue in the
accompanying consolidated balance sheet at September 30, 2009.
  FASB ASC
323 “Investments-Equity Method
and Joint Ventures” requires that the difference between the cost of an
investment and the amount of underlying equity in net assets of an investee
should be accounted for as if the investee were a consolidated subsidiary. The
Company has calculated the difference between the cost of the investment and the
amount of underlying equity in net assets of the joint venture to be $196,130,
based on the Company’s initial cost basis in the investment of $246,130, less
its 33.3% of the initial equity in net assets of the joint venture of
$50,000.  The Company will amortize the $196,130 over the term of the
shorter of the equipment usage or lease term (through April 2010, or 17 months
from December 1, 2008). The amortization will be applied against the value of
the Company’s investment. Amortization expense for the three and nine months
ending September 30, 2009 was $0 and $80,762.
  15
  The
following table is a summary of key financial data for the joint venture as of
and for the nine months ended September 30, 2009:
 
 Current
      assets
                      
                      $
                      152,902Noncurrent
      assets
                      
                      $
                      509,310Current
      liabilities
                      
                      $
                      296,762Noncurrent
      liabilities
                      
                      $
                      494,990Net
      revenue
                      
                      $
                      20,082Net
      loss
                      
                      $
                      (1,028,792
                      )
 
 The
following table is a summary of the activity from December 31, 2008 to September
30, 2009 in the Company’s investment in the joint venture:
 
 Balance,
      December 31, 2008
                      
                      $
                      225,200Losses
      attributable to investment
                      
                      
                      (144,438
                      )Amortization
      of premium
                      
                      
                      (80,762
                      )Balance,
      September 30, 2009
                      
                      $
                      -
 
 5.           AMENDED
AND RESTATED CONVERTIBLE DEBENTURES
 
 On July
29, 2009, the Company entered into a consent, amendment and exchange agreement
(the “Consent and Amendment”) with holders (the “Holders”) of the Company’s
outstanding convertible debentures and warrants to purchase shares of the
Company’s common stock (the “Warrants”), which were issued in private placements
to the 2005, 2006, 2007 and 2008 debentures.
  Amendment
and Forbearance to 2005, 2006, 2007 and 2008 Debentures
 
 Pursuant
to the Consent and Amendment, the Company agreed to issue to each Holder in
exchange for such Holder’s Debenture an amended and restated Debenture (the
“Amended and Restated Debentures”) in a principal amount equal to the principal
amount of such Holder’s Debenture times 1.35 minus any interest paid thereon.
The conversion price under the Amended and Restated Debentures was reduced to
$0.10, subject to further adjustment as provided therein (including for stock
splits, stock dividends, and certain subsequent equity sales). The maturity date
under the Amended and Restated Debentures was extended until December 31, 2010.
The Amended and Restated Debentures bear interest at the rate of 12% per annum,
which shall accrete to, and increase the principal amount payable upon maturity.
The Amended and Restated Debentures will amortize on September 25, 2009 and the
first day of each month thereafter until maturity at a rate of 6.25% of the
outstanding principal amount per month, valued at the lesser of the then
conversion price and 90% of the average volume weighted average price for the
ten prior trading days. The Company agreed to issue to each holder in exchange
for the holder’s warrants and amended and restated warrants (the “Amended and
Restated Warrants”), as well as additional warrants exercisable into 79,076,873
shares of the Company’s common stock for a total of warrants exercisable into
192,172,519 shares of common stock, both warrants containing a reduced exercise
price of $0.10, subject to certain customary anti-dilution adjustments
(including for stock splits, stock dividends, and certain subsequent equity
sales). The termination date under the Amended and Restated Warrants was
extended until June 30, 2014. Each Holder agreed not to convert more than 20% of
such Holder’s outstanding principal amount of Amended and Restated Debenture in
any month during the period from September 1, 2009 through January 31, 2010,
provided, however, that this limitation will terminate if (i)(a) the volume
weighted average price of the Company’s common stock for each of 5 consecutive
trading days is greater than $0.15 per share, and (b) the trading volume on such
days exceeds 7,500,000 shares per trading day, or (ii)(a) the volume weighted
average price for any one trading day is greater than $0.20 per share and (b)
the trading volume on such day exceeds 10,000,000 shares. The Company agreed to
amend its articles of incorporation to increase the number of authorized shares
of Common Stock (the “Amendment”). The Company agreed to increase the number of
shares available for issuance under the Company’s 2005 Stock Incentive Plan to
129,000,000 shares. The Holders agreed to waive any event of default under the
Debentures resulting solely from (i) any adjustment to the conversion price of
the Debenture and exercise price of the Warrants that would result from the
reduction of the conversion price of certain securities of the Company pursuant
to the Stipulation of Settlement, dated March 11, 2009, between the Company and
Alpha Capital, and (ii) any failure by the Company to reserve such number of
authorized but unissued shares of common stock issuable upon conversion of the
Debentures and exercise of the Warrants.
 
 16
  Simultaneously
with the execution of Consent and Amendment, and as a condition of the Consent
and Amendment, the Company and the Holders entered into a Standstill and
Forbearance Agreement (the “Forbearance Agreement”). Pursuant to the Forbearance
Agreement, the Company acknowledged certain defaults that have occurred under
the Debentures and documents executed in connection therewith (the “Transaction
Documents”). The Holders agreed to forbear from exercising their rights and
remedies under the Debentures and the Transaction Documents, and the Company
provided a general release in favor of the Holders. The obligation of the
Holders to forbear from exercising their rights and remedies under the
Debentures and the Transaction Documents will terminate on the earliest of (i)
the date, if any, on which a petition for relief under the date, if any, on
which a petition for relief under the United States Bankruptcy Code or any
similar state or Canadian law is filed by or against the Company or any of its
subsidiaries or (ii) the date the Forbearance Agreement is otherwise terminated
or expires, it being understood that the Holders holding 67% of the then
outstanding principal amount of the Debentures have the right to terminate the
Forbearance Agreement on 3 business days’ prior notice to the
Company.
 
 Other
than as amended in the Transaction Documents, the rights and obligations of the
holders and the Company with respect to the amended and restated debentures are
identical in all respects to the rights and obligations of the holders and the
Company with respect to the debentures and the underlying shares issued and
issuable pursuant to each purchase agreement.
 
 The
original 2005, 2006, 2007 and 2008 debenture agreements entered into provides
that the Company will pay certain cash amounts as liquidated damages in the
event that the Company does not maintain an effective registration statement, or
if the Company fails to timely execute stock trading activity. Additionally,
penalties will be incurred by the Company in the event of certain default
conditions.
 
 As long
as any portion of the amended and restated debentures remain outstanding, unless
the holders of at least 67% in principal amount of the then outstanding
debentures otherwise give prior written consent, the Company is not permitted to
(a) guarantee or borrow any indebtedness, (b) enter into any liens, (c) amend
its charter documents in any manner that materially and adversely affects any
rights of the holders, (d) acquire more than a de minimis number of shares of
its common stock equivalents other than as to conversion shares of warrant
shares as permitted or required and repurchases of common stock or common stock
equivalents of departing officers and directors of the Company, provided that
such purchases do not exceed certain specified amounts, (e) repay any
indebtedness, other than the debentures already issued on a pro-rata basis,
other than regularly scheduled principal payments as such terms are in effect
under this debenture, (f) pay cash dividends or distributions on any equity
securities of the Company, (g) enter into any material transaction with any
affiliate of the Company, unless such transaction is made on an arm’s-length
basis, or (h) enter into any agreement with respect to any of the
above.
 
 The
Company has considered the impact of FASB ASC 470-50 “Debt-Modifications and
Extinguishments” on the accounting treatment of the change in conversion
price of the 2005, 2006, 2007 and 2008 convertible debentures. FASB ASC 470-50
states that a transaction resulting in a significant change in the nature of a
debt instrument should be accounted for as an extinguishment of debt. The
difference between the reacquisition price and the net carrying amount of the
extinguished debt should be recognized currently in income of the period of
extinguishment. The Company has concluded that the issuance of the amended and
restated debentures constitutes a substantial modification. During the three
months ended September 30, 2009, the Company recognized a loss on extinguishment
of convertible debentures of $34,679,545 representing the difference between the
fair value of the amended and restated convertible debentures and the carrying
value of the original 2005, 2006, 2007 and 2008 convertible debentures. The fair
value of the amended and restated convertible debentures at July 29, 2009 was
$18,192,813, net of debt discounts of $2,011,065 that will be amortized over the
remaining life of the amended and restated convertible debentures. The following
table summarizes the convertible debentures:
  17
  December
      31, 20082005
      Convertible debenture and embedded derivatives, net of discounts of
      $0
                                          
                                          $
                                          85,9972006
      Convertible debenture and embedded derivatives, fair value
                                          
                                          
                                          1,993,3542007
      Convertible debenture and embedded derivatives, fair value
                                          
                                          
                                          7,706,344April
      2008 Convertible debenture and embedded derivatives
                                          
                                          
                                          4,066,505Fair
      value 2005, 2006, 2007 and 2008 convertible debentures
                                          
                                          $
                                          13,852,200Nine
      months ended September 30, 2009Convertible
      debenture conversions
                                          
                                          $
                                          (3,376,229
                                          )Change
      in fair value of embedded derivatives through July 29,
2009
                                          
                                          
                                          6,823,641Adjustment
      to bifurcate embedded derivatives upon adoption of FASB ASC
      815on
      July 29, 2009
                                          
                                          
                                          (7,629,147
                                          )Addition
      to principal to Alpha Capital
                                          
                                          
                                          110,000Accrued
      default interest on 2005, 2006, 2007 and 2008 convertible
      debentures,December
      31, 2008
                                          
                                          
                                          3,522,964Additional
      accrual of default interest through July 29, 2009
                                          
                                          
                                          1,227,181Loss
      on extinguishment on July 29, 2009
                                          
                                          
                                          767,778Amortization
      of debt discounts
                                          
                                          
                                          487,025September
      30, 2009 Balance, Amended and restated convertible
    debentures
                                          
                                          $
                                          15,785,413Less:
      current portion
                                          
                                          
                                          (12,849,395
                                          )Non-current
      portion
                                          
                                          $
                                          2,936,018
 
 Interest
expense from amortization of debt discounts for the three and nine months ended
September 30, 2009 was $487,025 and $0, respectively. Default interest expense
recognized for the three and nine months ended September 30, 2009 was $181,840
and $1,227,181, respectively.
 
 In
connection with the amended and restated convertible debentures, the Company
issued an additional 79,076,873 warrants to all holders. The warrants are in
addition to the 113,095,646 warrants held by the holders just before the
issuance of the amended and restated convertible debentures, for a total of
192,172,519 issued to the holders of the amended and restated convertible
debentures. The terms of the amended and restated warrants include a reduced
exercise price of $0.10, subject to certain customary anti-dilution adjustments.
The termination date under the amended and restated warrants was extended until
June 30, 2014. The fair value of the 113,095,646 warrants immediately prior to
the July 29, 2009 modification was estimated at $14,396,487 representing a
decrease in the fair value of the liability of $9,521,469 during the three
months ended September 30, 2009, which was recorded through the results of
operations as an adjustment to fair value of derivatives. The assumptions used
in the Black-Scholes option pricing model at July 29, 2009 are as follows: (1)
dividend yield of 0%; (2) expected volatility of 190%, (3) risk-free interest
rate of 0.50% - 1.72%, and (4) expected life of 1.09 – 3.68 years. The July 29,
2009 fair value of the 192,172,519 warrants was estimated at $29,956,246 using
the Black-Scholes pricing model. The total of 192,172,519 warrants were again
valued at $24,068,048 at September 30, 2009 at fair value using the
Black-Scholes model, representing a decrease in the fair value of the liability
of $14,397,252 during the three months ended September 30, 2009, which was
recorded through the results of operations as an adjustment to fair value of
derivatives. The assumptions used in the Black-Scholes option pricing model at
September 30, 2009 are as follows: (1) dividend yield of 0%; (2) expected
volatility of 185%, (3) risk-free interest rate of 2.31%, and (4) expected life
of 4.75 years.
 
 18
  The
Company has complied with the provisions of FASB ASC 815 “Derivatives and Hedging”,
and recorded the fair value of the embedded conversion option liability
associated with the amended and restated convertible debentures. The fair value
of the embedded conversion option was valued using the Black-Scholes model,
resulting in a fair value of $7,629,146 immediately prior to the July 29, 2009
modification. As of July 29, 2009, the convertible debentures were convertible
at the option of the holders into a total of 101,213,921 shares, subject to
anti-dilution and other customary adjustments. The decrease in fair value of
$8,550,020 was recorded through the results of operations as an adjustment to
fair value of derivatives during the three months ended September 30, 2009. The
assumptions used in the Black-Scholes option pricing model at July 29, 2009 are
as follows: (1) dividend yield of 0%; (2) expected volatility of 190%, (3)
risk-free interest rate of 0.14% – 0.50%, and (4) expected life of 0.01 – 1.09
years. As of September 30, 2009, the convertible debentures were convertible at
the option of the holders into a total of 173,094,530 shares, subject to
anti-dilution and other customary adjustments. The fair value of the embedded
conversion option was $16,609,866 at September 30, 2009, representing a decrease
in the fair value of the liability of $19,131,327 during the three months ended
September 30, 2009. The assumptions used in the Black-Scholes option pricing
model at September 30, 2009 are as follows: (1) dividend yield of 0%; (2)
expected volatility of 185%, (3) risk-free interest rate of 0.40%, and (4)
expected life of 1.25 years. Additionally, $1,796,368 was recorded in loss on
extinguishment of the 2008 convertible debenture during the nine months ended
September 30, 2009, prior to the July 29, 2009 modification, as a result of a
settlement with a debenture holder in February 2009. See Note 12.
 
 6.           AMENDED
CONVERTIBLE PROMISSORY NOTES
  On August
25, 2009, the Company entered into an amendment to its convertible promissory
notes with JMJ Financial, originally executed on February 14, 2008. The note has
been amended as follows:
 
 ·
              Note A: The
      original issue discount has been increased by 10%, or $60,000, such that
      the new principal amount is
$660,000.
 ·
              Note B: The
      original issue discount has been increased by 10%, or $120,000, such that
      the new principal amount is
$1,320,000.
 
 All other
terms and conditions of the original convertible promissory note remain in full
force and effect.
 
 Terms
of the Original Note
 
 The
Company issued and sold a $600,000 unsecured convertible note dated as of
February 15, 2008 (“Note A”) to JMJ Financial, for a net purchase price of
$500,000 (reflecting a 16.66% original issue discount) in a private placement.
Note A bears interest at the rate of 12% per annum, and is due by February 15,
2010. At any time after the 180th day following the effective date of Note A,
the holder may at its election convert all or part of Note A plus accrued
interest into shares of the Company's common stock at the conversion rate of the
lesser of: (a) $0.38 per share, or (b) 80% of the average of the three lowest
trade prices in the 20 trading days prior to the conversion. Pursuant to the Use
of Proceeds Agreement entered into in connection with the issuance of Note A,
the Company is required to use the proceeds from Note A solely for research and
development dedicated to adult stem cell research.
  Effective
February 15, 2008, in exchange for $1,000,000 in the form of a Secured &
Collateralized Promissory Note (the “JMJ Note”) issued by JMJ Financial to the
Company, the Company issued and sold an unsecured convertible note (“Note B”) to
JMJ Financial in the aggregate principal amount of $1,200,000 or so much as may
be paid towards the balance of the JMJ Note. Note B bears interest at the rate
of 10% per annum, and is due by February 15, 2010. At any time following the
effective date of Note B, the holder may at its election convert all or part of
Note B plus accrued interest into shares of the Company’s common stock at the
conversion rate of the lesser of: (a) $0.38 per share, or (b) 80% of the average
of the three lowest trade prices in the 20 trading days prior to the conversion.
In connection with the issuance of Note B, the Company entered into a Collateral
and Security Agreement dated as of February 15, 2008 with JMJ Financial pursuant
to which the Company granted JMJ Financial a security interest in certain of its
assets securing the JMJ Note. As of September 30, 2009, the Company had drawn
down and received the following amounts under Note B:
  19
  · On March 17, 2008 —
$60,000 for a net purchase price of $50,000 (reflecting a 16.66% original issue
discount).
 · On June 17, 2008 —
$60,000 for a net purchase price of $50,000 (reflecting a 16.66% original issue
discount).
 · On September 8,
2009 — $316,964 for a net purchase price of $250,000 (reflecting a 21.13%
original issue discount).
 · On September 30,
2009 — $976,250 for a net purchase price of $770,000 (reflecting a 21.13%
original issue discount).
  As long
as any portion of this Notes remain outstanding, unless the holders of at least
67% in principal amount of the then outstanding debentures otherwise give prior
written consent, the Company is not permitted to (a) guarantee or borrow any
indebtedness, (b) enter into any liens, (c) amend its charter documents in any
manner that materially and adversely affects any rights of the holders, (d)
acquire more than a de minimis number of shares of its common stock equivalents
other than as to conversion shares of warrant shares as permitted or required
and repurchases of common stock or common stock equivalents of departing
officers and directors of the Company, provided that such purchases do not
exceed certain specified amounts, (e) repay any indebtedness, other than the
debentures already issued on a pro-rata basis, other than regularly scheduled
principal payments as such terms are in effect under this debenture, (f) pay
cash dividends or distributions on any equity securities of the Company, (g)
enter into any material transaction with any affiliate of the Company, unless
such transaction is made on an arm’s-length basis, or (h) enter into any
agreement with respect to any of the above.
 
 The Note
agreement does not limit the number of shares that the Company could be required
to issue. The convertible debenture is convertible at the option of the holders
into a total of 10,420,077 shares of common stock at a conversion price of $0.10
per share at September 30, 2009, subject to anti-dilution and other customary
adjustments.
 
 Impact
of Modification
 
 The
Company has considered the impact of FASB ASC 470-50 “Debt-Modifications and
Extinguishments” on the accounting treatment of the change in conversion
price of the Notes. FASB ASC 470-50 states that a transaction resulting in a
significant change in the nature of a debt instrument should be accounted for as
an extinguishment of debt. The difference between the reacquisition price and
the net carrying amount of the extinguished debt should be recognized currently
in income of the period of extinguishment. The Company has concluded that the
issuance of the amendment to the February 15, 2008 convertible promissory notes
constitutes a substantial modification. During the three months ended September
30, 2009, the Company recognized a gain on extinguishment of convertible
debentures of $199,418 representing the difference between the fair value of the
amended and restated convertible promissory notes and the carrying value of the
original convertible promissory notes. The fair value of the amended convertible
debentures at August 25, 2009 was $828,818, net of debt discounts of $29,968
that will be amortized over the remaining life of the amended and restated
convertible debentures. The following table summarizes the convertible
promissory notes:
  20
  December
      31, 2008Fair
      value convertible promissory notes, December 31, 2008
                                
                                $
                                1,757,470Nine
      months ended September 30, 2009Convertible
      promissory note conversions
                                
                                $
                                (1,068,312
                                )Additional
      procceds from convertible promissory notes
                                
                                
                                1,020,000Change
      in fair value of embedded derivatives through August 15,
    2009
                                
                                
                                (478,521
                                )Adjustment
      to bifurcate embedded derivatives upon adoption of FASB ASC
      815on
      August 15, 2009
                                
                                
                                (558,949
                                )Accrued
      default interest on  convertible promissory notes, December 31,
      2008
                                
                                
                                194,420Additional
      accrual of default interest through August 15, 2009
                                
                                
                                84,151Accrued
      convertible promissory note interest through August 15,
    2009
                                
                                
                                79,720Gain
      on extinguishment on August 15, 2009
                                
                                
                                (249,473
                                )Amortization
      of debt discounts
                                
                                
                                77,355September
      30, 2009 Balance, Amended convertible promissory notes
                                
                                $
                                857,861Less:
      current portion
                                
                                
                                (857,861
                                )Non-current
      portion
                                
                                $
                                -
 
 Interest
expense from amortization of debt discounts for the three and nine months ended
September 30, 2009 was $77,355 and $77,355, respectively. Interest expense from
promissory note interest for the three and nine months ended September 30, 2009
was $25,357 and $45,663, respectively. Default interest expense recognized for
the three and nine months ended September 30, 2009 was $19,884 and $84,151,
respectively.
 
 The
Company has complied with the provisions of FASB ASC 815 “Derivatives and Hedging”,
and recorded the fair value of the embedded conversion option liability
associated with the amended convertible promissory notes. The fair value of the
embedded conversion option was valued using the Black-Scholes model, resulting
in a fair value of $558,949 immediately prior to the August 15, 2009
modification. As of August 15, 2009, the convertible promissory notes were
convertible at the option of the holders into a total of 7,934,211 shares just
prior to modification and into a total of 8,644,737 shares just after the
modification, subject to anti-dilution and other customary adjustments. The
decrease in fair value of $496,955 was recorded through the results of
operations as an adjustment to fair value of derivatives during the three months
ended September 30, 2009. The assumptions used in the Black-Scholes option
pricing model at August 15, 2009 are as follows: (1) dividend yield of 0%; (2)
expected volatility of 185%, (3) risk-free interest rate of 0.26%, and (4)
expected life of 0.48 years. As of September 30, 2009, the convertible
promissory notes were convertible at the option of the holders into a total of
10,420,077 shares, subject to anti-dilution and other customary adjustments. The
fair value of the embedded conversion option was $669,529 at September 30, 2009,
representing a decrease in the fair value of the liability of $436,430 during
the three months ended September 30, 2009. The assumptions used in the
Black-Scholes option pricing model at September 30, 2009 are as follows: (1)
dividend yield of 0%; (2) expected volatility of 185%, (3) risk-free interest
rate of 0.18%, and (4) expected life of 0.38 years.
 
 During
the three months ended September 30, 2009, the Company converted the entire
$732,000 of Note A into 8,061,264 shares of its common stock, and $336,312 of
Note B into 3,553,600 shares of its common stock.
 
 7.
WARRANT
DERIVATIVE LIABILITIES
 
 The
following tables summarize the components of the warrant derivative liabilities
at September 30, 2009 and December 31, 2008.
  21
  September 30,
                        
                        
                        December 31,2009
                        
                        
                        2008Warrants
      - 2005 debenture
                        
                        $
                        3,210,163
                        
                        
                        $
                        29,322Warrants
      - 2006 debenture
                        
                        
                        4,920,310
                        
                        
                        
                        274,593Warrants
      - 2007 debenture
                        
                        
                        12,026,820
                        
                        
                        
                        737,745Warrants
      - 2008 debenture
                        
                        
                        3,910,760
                        
                        
                        
                        822,043Other
      warrant derivatives
                        
                        
                        935,182
                        
                        
                        
                        792,146$
                        25,003,235
                        
                        
                        $
                        2,655,849
 
 8.
EMBEDDED
CONVERSION OPTION LIABILITIES
  The
following tables summarize the components of the embedded conversion option
liabilities at September 30, 2009 and December 31, 2008.
 
 September 30,
                      
                      
                      December 31,2009
                      
                      
                      2008Amended
      and restated 2005 debenture
                      
                      $
                      126,090
                      
                      
                      $
                      -Amended
      and restated 2006 debenture
                      
                      
                      2,430,531
                      
                      
                      
                      -Amended
      and restated 2007 debenture
                      
                      
                      8,505,258
                      
                      
                      
                      -Amended
      and restated 2008 debenture
                      
                      
                      5,547,987
                      
                      
                      
                      -Amended
      and restated 2008 convertible promissory note
                      
                      
                      669,529
                      
                      
                      
                      -Series
      A-1 convertible preferred stock
                      
                      
                      325,953
                      
                      
                      
                      -$
                      17,605,348
                      
                      
                      $
                      -
 
 9.
CHANGE IN FAIR VALUE OF DERIVATIVE LIABILITIES
 
 The
following table summarizes by category of derivative liability the increase
(decrease) in fair value from market changes during the three months ended
September 30, 2009 and 2008.
  Three Months Ended
                                September 30, 2009
                              
                              
                              Three Months Ended
                                September 30, 2008Embedded conversion option liability –
      2005 debenture
                              
                              $
                              (86,036
                              )
                              
                              $
                              1,030Embedded
      conversion option liability – 2006 debenture
                              
                              
                              (1,972,378
                              )
                              
                              
                              68,832Embedded
      conversion option liability – 2007 debenture
                              
                              
                              (10,730,207
                              )
                              
                              
                              (168,902
                              )Embedded
      conversion option liability – 2008 convertible promissory
    note
                              
                              
                              (436,430
                              )
                              
                              
                              119,913Embedded
      conversion option liability – 2008 debenture
                              
                              
                              (6,342,706
                              )
                              
                              
                              220,290Embedded
      conversion option liability – Series A-1 convertible preferred
      stock
                              
                              
                              (295,670
                              )
                              
                              
                              -Original
      warrants 2005 debenture, excluding replacement warrants
                              
                              
                              (956,796
                              )
                              
                              
                              (59,919
                              )2005
      debenture - replacement warrants
                              
                              
                              (497,679
                              )
                              
                              
                              (379,198
                              )Warrants
      – 2006 debenture
                              
                              
                              (1,603,254
                              )
                              
                              
                              (600,929
                              )Warrants
      – 2007 debenture
                              
                              
                              (6,485,510
                              )
                              
                              
                              (1,497,367
                              )Warrants
      – 2008 debenture
                              
                              
                              (3,698,252
                              )
                              
                              
                              (991,988
                              )Other
      warrant derivatives
                              
                              
                              (3,649,387
                              )
                              
                              
                              (474,301
                              )$
                              (36,754,306
                              )
                              
                              $
                              (3,762,539
                              )
 
 22
  The
following table summarizes by category of derivative liability the increase
(decrease) in fair value from market changes during the nine months ended
September 30, 2009 and 2008.
 
 Nine Months Ended
                                September 30, 2009
                              
                              
                              Nine Months Ended
                                September 30, 2008Embedded
      conversion option liability – 2005 debenture
                              
                              $
                              (36,214
                              )
                              
                              $
                              (167,827
                              )Embedded
      conversion option liability – 2006 debenture
                              
                              
                              (1,145,667
                              )
                              
                              
                              (626,959
                              )Embedded
      conversion option liability – 2007 debenture
                              
                              
                              (1,651,491
                              )
                              
                              
                              1,132,374Embedded
      conversion option liability – 2008 convertible promissory
    note
                              
                              
                              (417,996
                              )
                              
                              
                              (138,719
                              )Embedded
      conversion option liability – 2008 debenture
                              
                              
                              (2,720,663
                              )
                              
                              
                              79,185Embedded
      conversion option liability – Series A-1 convertible preferred
      stock
                              
                              
                              (26,916
                              )
                              
                              
                              -Original
      warrants 2005 debenture, excluding replacement warrants
                              
                              
                              (588,763
                              )
                              
                              
                              (215,933
                              )2005
      debenture - replacement warrants
                              
                              
                              1,930,125
                              
                              
                              
                              (1,336,716
                              )Warrants
      – 2006 debenture
                              
                              
                              2,070,038
                              
                              
                              
                              (2,079,265
                              )Warrants
      – 2007 debenture
                              
                              
                              1,146,755
                              
                              
                              
                              (4,784,154
                              )Warrants
      – 2008 debenture
                              
                              
                              2,878,442
                              
                              
                              
                              (1,808,220
                              )Other
      warrant derivatives
                              
                              
                              (648,969
                              )
                              
                              
                              (2,044,021
                              )$
                              788,680
                              
                              
                              $
                              (11,989,715
                              )
 
 10.           SERIES
A-1 REDEEMABLE CONVERTIBLE PREFERRED STOCK
 
 Effective
March 3, 2009, the Company entered into a $5 million credit facility
(“Facility”) with a life sciences fund. Under the terms of the agreement, the
Company may draw down funds, as needed, from the investor through the issuance
of Series A-1 redeemable convertible preferred stock, par value $.001, at a
basis of 1 share of Series A-1 redeemable convertible preferred stock for every
$10,000 invested.
 
 Conversion
Rights
 
 Any
shares of Series A-1 redeemable convertible preferred stock may, at the option
of the holder, be converted at any time into shares of common stock. The
conversion price for the preferred stock is equal to $0.75 per share of common
stock. The Company must keep available out of its authorized but unissued shares
of common stock, such number of shares sufficient to effect a conversion of all
then outstanding shares of the Series A-1 redeemable convertible preferred
stock. If at any time the number of authorized but unissued shares of common
stock is not sufficient to effect a conversion of all then outstanding shares of
the Series A-1 redeemable convertible preferred stock, the Company must take
necessary action to increase its authorized but unissued shares of common stock
to such number of shares as is sufficient for conversion.
 
 23
  Dividends
 
 The
preferred stock pays dividends, in kind of preferred stock, at an annual rate of
10%, matures in four years from the initial drawdown date, and is convertible
into common stock at $0.75 per share.
 
 Redemption
Rights
 
 Upon the
earlier of (i) the fourth anniversary of the issuance date, and (ii) the
occurrence of a major transaction, each holder shall have the right, at such
holder’s option, to require the Company to redeem all or a portion of such
holder’s share of Series A-1 preferred stock, at a price per share equal to the
Series A-1 liquidation value. The Company has the option to pay the redemption
price in cash or in shares of its common stock. A major transaction includes (i)
the consolidation, merger, or other business combination of the Company with or
into another entity, (ii) the sale or transfer of more than 50% of the Company’s
assets other than inventory in the ordinary course of business in one or more
related series of transactions, or (iii) closing of a purchase, tender or
exchange offer made  to the holders of more than 50% of the
outstanding shares of common stock in which more than 50% of the outstanding
shares of common stock were tendered and accepted. The Company shall have the
right, at its own option, to redeem all or a portion of the shares of Series A-1
redeemable preferred stock, at any time at a price per share of Series A-1
redeemable preferred stock equal to 100% of the Series A-1 liquidation value. In
the event the closing price of the our common stock during the 5 trading days
following the put notice falls below 75% of the average of the closing bid price
in the 5 trading days prior to the put closing date, the investor may, at its
option, and without penalty, decline to purchase the applicable put shares on
the put closing date.
 
 Termination
and Liquidation Rights
 
 The
Company may terminate this agreement and its right to initiate future draw-downs
by providing 30 days advanced written notice to the investor. Upon any
liquidation, dissolution or winding up of the Company, whether voluntary or
involuntary, after payment or provision for payment of debts and other
liabilities of the Corporation, before any distribution or payment shall be made
to the holders of any other equity securities of the Company by reason of their
ownership thereof, the holders of the Series A-1 redeemable convertible
preferred stock shall first be entitled to be paid out of the assets of the
Company available for distribution to its stockholders an amount with respect to
each share of Series A-1 redeemable convertible preferred stock equal to
$10,000, plus any accrued by unpaid dividends. If, upon dissolution or winding
up of the Company, the assets of the Company shall be insufficient to make
payment in full to all holders, then such assets shall be distributed among the
holders at the time outstanding, ratably in proportion to the full amounts to
which they would otherwise be respectively entitled. During the nine months
ended September 30, 2009, the Company drew down $2,288,000 on this credit
facility.
 
 Because
this instrument is redeemable, the Company determined that the Series A-1
redeemable preferred stock should be classified within the mezzanine section
between liabilities and equity in its consolidated balance sheets. The embedded
conversion option has been recorded as a derivative liability in the Company’s
consolidated balance sheets, and changes in the fair value each reporting period
will be reported in adjustments to fair value of derivatives in the consolidated
statements of operations.
 
 The
outstanding balance at September 30, 2009 of $2,288,000 is convertible into
3,050,667 shares of the Company’s common stock. The Company values the
conversion option initially when each draw takes place. The following table
summarizes the assumptions used in the Black-Scholes model to value the
conversion option associated with each draw, along with the fair value of the
embedded conversion option.
  24
  Black-Scholes Assumptionsat Draw DateDraw
                                    
                                    Draw
                                    
                                    Dividend
                                    
                                    
                                    Expected
                                    
                                    
                                    Risk-Free
                                    
                                    
                                    Expected
                                    
                                    
                                    FairAmount
                                    
                                    Date
                                    
                                    Yield
                                    
                                    
                                    Volatility
                                    
                                    
                                    Rate
                                    
                                    
                                    Life (Yrs)
                                    
                                    
                                    Value$
                                    1,100,000
                                    
                                    4/6/2009
                                    
                                    
                                    0
                                    %
                                    
                                    
                                    190
                                    %
                                    
                                    
                                    1.90
                                    %
                                    
                                    
                                    4.00
                                    
                                    
                                    $
                                    139,98587,000
                                    
                                    4/28/2009
                                    
                                    
                                    0
                                    %
                                    
                                    
                                    190
                                    %
                                    
                                    
                                    1.83
                                    %
                                    
                                    
                                    3.94
                                    
                                    
                                    
                                    9,951105,000
                                    
                                    5/1/2009
                                    
                                    
                                    0
                                    %
                                    
                                    
                                    190
                                    %
                                    
                                    
                                    2.03
                                    %
                                    
                                    
                                    3.93
                                    
                                    
                                    
                                    12,00781,036
                                    
                                    5/19/2009
                                    
                                    
                                    0
                                    %
                                    
                                    
                                    190
                                    %
                                    
                                    
                                    2.12
                                    %
                                    
                                    
                                    3.88
                                    
                                    
                                    
                                    12,204162,624
                                    
                                    6/9/2009
                                    
                                    
                                    0
                                    %
                                    
                                    
                                    190
                                    %
                                    
                                    
                                    2.86
                                    %
                                    
                                    
                                    3.83
                                    
                                    
                                    
                                    28,428131,644
                                    
                                    6/15/2009
                                    
                                    
                                    0
                                    %
                                    
                                    
                                    190
                                    %
                                    
                                    
                                    2.75
                                    %
                                    
                                    
                                    3.81
                                    
                                    
                                    
                                    26,23767,457
                                    
                                    6/26/2009
                                    
                                    
                                    0
                                    %
                                    
                                    
                                    190
                                    %
                                    
                                    
                                    2.53
                                    %
                                    
                                    
                                    3.78
                                    
                                    
                                    
                                    20,14575,000
                                    
                                    6/29/2009
                                    
                                    
                                    0
                                    %
                                    
                                    
                                    190
                                    %
                                    
                                    
                                    2.53
                                    %
                                    
                                    
                                    3.77
                                    
                                    
                                    
                                    22,38654,811
                                    
                                    7/23/2009
                                    
                                    
                                    0
                                    %
                                    
                                    
                                    185
                                    %
                                    
                                    
                                    2.60
                                    %
                                    
                                    
                                    3.71
                                    
                                    
                                    
                                    10,65834,224
                                    
                                    7/23/2009
                                    
                                    
                                    0
                                    %
                                    
                                    
                                    185
                                    %
                                    
                                    
                                    2.60
                                    %
                                    
                                    
                                    3.71
                                    
                                    
                                    
                                    6,65554,340
                                    
                                    7/23/2009
                                    
                                    
                                    0
                                    %
                                    
                                    
                                    185
                                    %
                                    
                                    
                                    2.60
                                    %
                                    
                                    
                                    3.71
                                    
                                    
                                    
                                    10,56640,755
                                    
                                    7/24/2009
                                    
                                    
                                    0
                                    %
                                    
                                    
                                    185
                                    %
                                    
                                    
                                    2.57
                                    %
                                    
                                    
                                    3.70
                                    
                                    
                                    
                                    7,42425,000
                                    
                                    8/3/2009
                                    
                                    
                                    0
                                    %
                                    
                                    
                                    185
                                    %
                                    
                                    
                                    2.66
                                    %
                                    
                                    
                                    3.68
                                    
                                    
                                    
                                    4,54475,000
                                    
                                    8/5/2009
                                    
                                    
                                    0
                                    %
                                    
                                    
                                    185
                                    %
                                    
                                    
                                    2.73
                                    %
                                    
                                    
                                    3.67
                                    
                                    
                                    
                                    11,80675,000
                                    
                                    8/14/2009
                                    
                                    
                                    0
                                    %
                                    
                                    
                                    185
                                    %
                                    
                                    
                                    2.73
                                    %
                                    
                                    
                                    3.65
                                    
                                    
                                    
                                    12,686119,109
                                    
                                    8/28/2009
                                    
                                    
                                    0
                                    %
                                    
                                    
                                    185
                                    %
                                    
                                    
                                    2.46
                                    %
                                    
                                    
                                    3.61
                                    
                                    
                                    
                                    17,186$
                                    2,288,000
                                    
                                    
                                    
                                    
                                    
                                    
                                    
                                    
                                    
                                    
                                    
                                    
                                    
                                    
                                    
                                    
                                    
                                    
                                    
                                    $
                                    352,869
 
 The
embedded conversion option was again valued at $325,953 at September 30, 2009 at
fair value using the Black-Scholes model. The decrease in the fair value of the
embedded conversion option liability of $295,670 and $26,916 for the three and
nine months ended September 30, 2009, respectively, was recorded through the
results of operations as an adjustment to fair value of derivatives. The
assumptions used in the Black-Scholes model to value the embedded conversion
option at September 30, 2009 were as follows: (1) dividend yield of 0%;
(2) expected volatility of 185%, (3) risk-free interest rate of 1.45%,
and (4) expected life of 3.52 years.
 
 The
following table summarizes the Series A-1 redeemable convertible preferred stock
and embedded derivative outstanding at September 30, 2009 and at initial draw
dates:
 
 September 30,
                        
                        
                        Inception
                        
                        
                        Increase2009
                        
                        
                        Dates*
                        
                        
                        (Decrease)Principal
      due
                        
                        $
                        2,288,000
                        
                        
                        $
                        2,288,000
                        
                        
                        $
                        -Accrued
      dividend
                        
                        
                        84,209
                        
                        
                        
                        -
                        
                        
                        
                        84,209Debt
      discount
                        
                        
                        (321,738
                        )
                        
                        
                        (352,869
                        )
                        
                        
                        31,1312,050,471
                        
                        
                        
                        1,935,131
                        
                        
                        
                        115,340Less
      current portion
                        
                        
                        -
                        
                        
                        
                        -
                        
                        
                        
                        -Non-current
      portion
                        
                        $
                        2,050,471
                        
                        
                        $
                        1,935,131
                        
                        
                        $
                        115,340Aggregate
      liquidation value**
                        
                        
                        2,372,209
                        
                        
                        $
                        2,288,000
                        
                        
                        $
                        199,549
 
 *Represents
the sum of values from various draw dates on the Series A-1 redeemable
convertible preferred stock facility.
 **Represents the sum of
principal due and accrued dividends.
 
 The
dividends are accrued at a rate of 10% per annum, and the Company records the
accrual as interest expense in its consolidated statements of operations in the
period incurred. The Company recorded accrued dividends on the Series A-1
redeemable convertible preferred stock of $52,861 and $84,209 for the three and
nine months ended September 30, 2009, respectively.
 
 25
  For
providing investor relations services in connection with the Series A-1
redeemable convertible preferred stock credit facility, the Company issued a
consultant 24,900,000 shares of its common stock on February 9, 2009. The
Company valued the issuance of these shares at $4,731,000 based on a closing
price of $0.19 on February 9, 2009 and recorded the value of the shares as
deferred financing costs associated with the financing on the date they were
issued. Beginning on the date of the first draw-down on April 6, 2009 (the loan
maturity date is 4 years after the initial draw-down), each quarter the Company
will amortize the deferred issuance costs ratably over the term of the Series
A-1 redeemable convertible preferred stock facility.
 
 The
Company also incurred a non-refundable commitment fee to the holder of this
convertible preferred stock facility in the amount of $250,000. The fee is
payable by the Company in either (a) cash, or (b) common stock. If paid in
common stock, the Company will issue a number of shares valued at 97% of the
volume-weighted average price of its common stock for the five trading days
immediately preceding the effective date of the facility, or March 3, 2009.
Based on this, the Company would be required to issue approximately 2,152,000
shares of the Company’s common stock. Beginning on the date of the first
draw-down on April 6, 2009 (the loan maturity date is 4 years after the initial
draw-down), each quarter the Company amortizes the deferred issuance costs
ratably over the term of the Series A-1 redeemable convertible preferred stock
facility.
 
 Interest
expense from amortization of the debt discount and deferred issuance costs for
the three and nine months ended September 30, 2009 was $334,560 and $634,580,
respectively.
 
 11.           WARRANT
SUMMARY
 
 Warrant
Activity
  A summary
of warrant activity for the nine months ended September 30, 2009 is presented
below:
 
 WeightedWeighted
                              
                              
                              Average
                              
                              
                              AggregateAverage
                              
                              
                              Remaining
                              
                              
                              IntrinsicNumber of
                              
                              
                              Exercise
                              
                              
                              Contractual
                              
                              
                              ValueWarrants
                              
                              
                              Price
                              
                              
                              Life (in years)
                              
                              
                              (000)Outstanding, December
      31, 2008
                              
                              
                              129,397,951
                              
                              
                              $
                              0.26
                              
                              
                              
                              3.23
                              
                              
                              $
                              -Granted
                              
                              
                              79,076,872
                              
                              
                              
                              -Exercised
                              
                              
                              -
                              
                              
                              
                              -Forfeited
                              
                              
                              (3,049,258
                              )
                              
                              $
                              1.35Outstanding,
      September 30, 2009
                              
                              
                              205,425,565
                              
                              
                              $
                              0.14
                              
                              
                              
                              4.56
                              
                              
                              
                              5,765Vested and expected
      to vest at
      September 30, 2009
                              
                              
                              205,425,565
                              
                              
                              $
                              0.14
                              
                              
                              
                              4.56
                              
                              
                              
                              5,765Exercisable,
      September 30, 2009
                              
                              
                              205,425,565
                              
                              
                              $
                              0.14
                              
                              
                              
                              4.56
                              
                              
                              
                              5,765
 
 The
aggregate intrinsic value in the table above is before applicable income taxes
and is calculated based on the difference between the exercise price of the
warrants and the quoted price of the Company’s common stock as of the reporting
date.
  26
  The
following table summarizes information about warrants outstanding and
exercisable at September 30, 2009:
 
 Warrants Outstanding
                              
                              
                              Warrants ExercisableWeighted
                              
                              
                              Weighted
                              
                              
                              
                              
                              
                              WeightedAverage
                              
                              
                              Average
                              
                              
                              
                              
                              
                              AverageExercise
                              
                              Number
                              
                              
                              Remaining
                              
                              
                              Exercise
                              
                              
                              Number
                              
                              
                              ExercisePrice
                              
                              of Shares
                              
                              
                              Life (Years)
                              
                              
                              Price
                              
                              
                              of Shares
                              
                              
                              Price$
                              0.10
                              
                              
                              192,172,518
                              
                              
                              
                              4.75
                              
                              
                              $
                              0.10
                              
                              
                              
                              192,172,518
                              
                              
                              $
                              0.100.34
                              
                              
                              3,720,588
                              
                              
                              
                              1.01
                              
                              
                              
                              0.34
                              
                              
                              
                              3,720,588
                              
                              
                              
                              0.340.38
      - 0.40
                              
                              
                              3,080,636
                              
                              
                              
                              4.19
                              
                              
                              
                              0.39
                              
                              
                              
                              3,080,636
                              
                              
                              
                              0.390.85
      - 0.96
                              
                              
                              5,734,831
                              
                              
                              
                              1.21
                              
                              
                              
                              0.95
                              
                              
                              
                              5,734,831
                              
                              
                              
                              0.952.20
                              
                              
                              72,917
                              
                              
                              
                              1.88
                              
                              
                              
                              2.20
                              
                              
                              
                              72,917
                              
                              
                              
                              2.202.48
      - 2.54
                              
                              
                              644,075
                              
                              
                              
                              0.81
                              
                              
                              
                              2.54
                              
                              
                              
                              644,075
                              
                              
                              
                              2.54205,425,565
                              
                              
                              
                              
                              
                              
                              
                              
                              
                              
                              
                              205,425,565
 
 12.
STOCKHOLDERS’ EQUITY TRANSACTIONS
 
 On
September 10, 2009, upon approval by a vote of the Company’s stockholders, the
Company increased its authorized shares of common stock, par value $0.001 from
500,000,000 to 1,750,000,000 shares, effective immediately.
 
 The
Company is authorized to issue two classes of capital stock, to be designated,
respectively, preferred stock and common stock. The total number of shares of
Series A-1 redeemable convertible preferred stock the Company is authorized to
issue is 50,000,000, par value $0.001 per share. The total number of shares of
common stock the Company is authorized to issue is 1,750,000,000, par value
$0.001 per share. The Company had 229 shares of Series A-1 redeemable
convertible preferred Stock outstanding as of September 30, 2009 and 547,964,766
shares of common stock outstanding as of September 30, 2009.
 
 Between
September 29, 2008 and January 20, 2009, the Company was ordered by the Circuit
Court of the Twelfth Judicial District Court for Sarasosa County, Florida to
settle certain past due accounts payable, for previous professional services and
other operating expenses incurred, by the issuance of shares of its common
stock. In aggregate, through September 30, 2009, the Company settled $1,108,673
in accounts payable through the issuance of 260,116,283 shares of its common
stock. During the nine months ended September 30, 2009, the Company settled
$505,199 in accounts payable through the issuance of 39,380,847 shares of its
common stock. The Company recorded a loss on settlement of $4,793,949 in its
accompanying statement of operations for the nine months ended September 30,
2009. The losses were calculated as the difference between the amount of
accounts payable relieved and the value of the shares (based on the closing
share price on the settlement date) that were issued to relieve the accounts
payable.
 
 On March
5, 2009, the Company settled a lawsuit originally brought by an investor in
January 2009, who is an investor in the 2007 and 2008 debentures, and associated
with the default on August 6, 2008 on all debentures. As a result of the
lawsuit, the Company was required by court order to reduce the conversion price
on convertible debentures held by this investor to $0.02 per share, effective
immediately, so long as the Company has a sufficient number of authorized shares
to honor the request for conversion. During the nine months ended September 30,
2009, the Company issued 4,847,050 shares of its common stock to this investor
in conversion of approximately $97,000 of its 2006 debenture at $0.02 per share,
and 1,252,950 shares of its common stock to this investor in conversion of
approximately $25,000 of its 2007 debenture at $0.02 per share. The Company has
considered the impact of FASB ASC 470-50 “Debt-Modifications and
Extinguishments”on the accounting treatment of the change in conversion
price of the 2007 and 2008 convertible debentures. FASB ASC 470-50 states that a
transaction resulting in a significant change in the nature of a debt instrument
should be accounted for as an extinguishment of debt. The difference between the
reacquisition price and the net carrying amount of the extinguished debt should
be recognized currently in income of the period of extinguishment. The Company
calculated the fair value of the conversion option for the 2007 and April 2008
debentures immediately prior to and after the change in the conversion price,
and evaluated the impact of the change in conversion price. The Company has
concluded that the change in conversion price for this investor constitutes a
substantial modification in the terms of the 2007 and 2008 debenture agreements.
Based on the Company’s evaluation, the below table summarizes the impact
relative to the debentures’ face value on March 5, 2009.
 
 27
 DebentureImpact on Debentures
                      
                      Change
                      
                      
                      Face Value
                      
                      
                      % Change2007 Debenture
                      
                      $
                      1,319,354
                      
                      
                      $
                      6,739,214
                      
                      
                      
                      20
                      %April
      2008 Debenture
                      
                      $
                      477,014
                      
                      
                      $
                      4,038,880
                      
                      
                      
                      12
                      %1,796,368
                      
                      
                      $
                      10,778,094
 
 The
change in fair value of the conversion option on the 2007 debenture was
$1,319,354, or a 20% change relative to the face value of the debenture. The
change in fair value of the conversion option on the April 2008 debenture was
$477,014, or a 12% change relative to the face value of the debenture. The
Company recorded a loss on extinguishment of debentures in the amount of
$1,796,368 during the nine months ended September 30, 2009 as a result of this
modification, representing the difference between the fair value of the new debt
and the carrying value of the original debt.
 
 On June
30, 2009, Alpha Capital submitted a conversion notice in the principal amount of
$150,000 into 7,500,000 shares of common stock at $0.02 per share. At that time,
the Company did not have sufficient authorized shares to satisfy this conversion
notice. On July 6, 2009, by means of a settlement between the 2 parties, the
Company agreed to deliver the 7,500,000 shares of its common stock no later than
September 25, 2009.  The Company delivered the 7,500,000 shares on
September 25, 2009. Further, the Company agreed to provide Alpha Capital with an
additional $110,000 principal, which is to be upon the same terms and conditions
as the original April 2008 debenture. Accordingly, the Company recognized a loss
on settlement in the amount of $110,000 during the three months ended September
30, 2009 for the amount of principal that was added to the April 2008
convertible debenture. Additionally, the Company recognized interest expense in
the amount of $1,210,021, representing the fair value of the conversion option
of the $110,000 on July 6, 2009. The full amount of $1,210,021 was recognized in
interest expense as a result of the debenture’s default at the
time.
 
 13.
STOCK-BASED COMPENSATION
 
 Stock
Plans
 
 On August
12, 2004, ACT’s Board of Directors approved the establishment of the 2004 Stock
Option Plan (the “2004 Stock Plan”). Stockholder approval was received on
December 13, 2004. The total number of common shares available for grant and
issuance under the plan may not exceed 2,800,000 shares, subject to adjustment
in the event of certain recapitalizations, reorganizations and similar
transactions. Common stock purchase options may be exercisable by the payment of
cash or by other means as authorized by the Board of Directors or a committee
established by the Board of Directors. At September 30, 2009, the Company had
820,000 common share purchase options outstanding under the plan. At September
30, 2009, there were 370,000 options available for grant under this
plan.
  On
December 13, 2004, ACT’s Board of Directors and stockholders approved the
establishment of the 2004 Stock Option Plan II (the “2004 Stock Plan II”). The
total number of common shares available for grant and issuance under the plan
may not exceed 1,301,161 shares, subject to adjustment in the event of certain
recapitalizations, reorganizations and similar transactions. Common stock
purchase options may be exercisable by the payment of cash or by other means as
authorized by the Board of Directors or a committee established by the Board of
Directors. At September 30, 2009, ACT had granted 1,301,161 common share
purchase options under the plan. At September 30, 2009, no options were
available for grant under this plan.
  28
  On
January 31, 2005, the Company’s Board of Directors approved the establishment of
the 2005 Stock Incentive Plan (the “2005 Plan”) for its employees, subject to
approval of our shareholders. Under the original 2005 Plan, the total number of
common shares available for grant and issuance under the plan could not exceed 9
million shares, plus an annual increase on the first day of each of the
Company’s fiscal years beginning in 2006 equal to 5% of the number of shares of
our common stock outstanding on the last day of the immediately preceding fiscal
year, subject to adjustment in the event of certain recapitalizations,
reorganizations and similar transactions. On January 24, 2008, the Company’s
shareholders approved an increase of 25,000,000 shares to the 2005 Plan. Common
stock purchase options may be exercisable by the payment of cash or by other
means as authorized by the Board of Directors or a committee established by the
Board of Directors. On September 10, 2009, upon approval by a vote of the
Company’s stockholders, the Company increased the number of shares of common
stock issuable under the 2005 Plan to a total of 145,837,250 shares, issuable as
options or shares of common stock. At September 30, 2009, 12,364,419 common
stock purchase options were outstanding and the Company issued 1,497,263 shares
of common stock under the plan. At September 30, 2009, there were 133,456,831
shares of common stock available for issuance under this plan.
  Stock
Option Activity
  A summary
of option activity for the nine months ended September 30, 2009 is presented
below:
 
 WeightedWeighted
                          
                          
                          Average
                          
                          
                          AggregateAverage
                          
                          
                          Remaining
                          
                          
                          IntrinsicNumber of
                          
                          
                          Exercise
                          
                          
                          Contractual
                          
                          
                          ValueOptions
                          
                          
                          Price
                          
                          
                          Life (in years)
                          
                          
                          (000)Outstanding,
      January 1, 2009
                          
                          
                          14,485,580
                          
                          
                          $
                          0.55
                          
                          
                          
                          7.25
                          
                          
                          $
                          -Granted
                          
                          
                          -
                          
                          
                          
                          -Exercised
                          
                          
                          -
                          
                          
                          
                          -Forfeited
                          
                          
                          -
                          
                          
                          
                          -Outstanding,
      September 30, 2009
                          
                          
                          14,485,580
                          
                          
                          $
                          0.55
                          
                          
                          
                          6.50
                          
                          
                          $
                          66Vested
      and expected to vestat September 30, 2009
                          
                          
                          14,066,932
                          
                          
                          
                          0.56
                          
                          
                          
                          6.44
                          
                          
                          
                          66Exercisable,
      September 30, 2009
                          
                          
                          11,265,207
                          
                          
                          
                          0.64
                          
                          
                          
                          5.97
                          
                          
                          
                          66
  The
aggregate intrinsic value in the table above is before applicable income taxes
and is calculated based on the difference between the exercise price of the
options and the quoted price of the Company’s common stock as of the reporting
date.
  A summary
of the status of unvested employee stock options as of September 30, 2009 and
changes during the period then ended, is presented below:
 
 WeightedAverageGrant
      DateFair
      ValueShares
                            
                            
                            Per
      ShareUnvested
      at January 1, 2009
                            
                            
                            4,769,159
                            
                            
                            $
                            0.23Granted
                            
                            
                            -
                            
                            
                            
                            -Vested
                            
                            
                            (1,548,786
                            )
                            
                            
                            0.27Forfeited
                            
                            
                            -
                            
                            
                            
                            -Unvested
      at September 30, 2009
                            
                            
                            3,220,373
                            
                            
                            $
                            0.21
  As of
September 30, 2009, total unrecognized stock-based compensation expense related
to nonvested stock options was approximately $586,000, which is expected to be
recognized over a weighted average period of approximately
8.35 years.
  29
  The
following table summarizes information about stock options outstanding and
exercisable at September 30, 2009.
 
 Options Outstanding
                            
                            
                            Options ExercisableWeighted
                            
                            
                            Weighted
                            
                            
                            
                            
                            
                            WeightedAverage
                            
                            
                            Average
                            
                            
                            
                            
                            
                            AverageExercise
                            
                            Number
                            
                            
                            Remaining
                            
                            
                            Exercise
                            
                            
                            Number
                            
                            
                            ExercisePrice
                            
                            of Shares
                            
                            
                            Life (Years)
                            
                            
                            Price
                            
                            
                            of Shares
                            
                            
                            Price$
                            0.05
                            
                            
                            820,000
                            
                            
                            
                            4.87
                            
                            
                            $
                            0.05
                            
                            
                            
                            820,000
                            
                            
                            $
                            0.050.21
                            
                            
                            6,007,403
                            
                            
                            
                            8.12
                            
                            
                            
                            0.21
                            
                            
                            
                            2,794,946
                            
                            
                            
                            0.210.25
                            
                            
                            1,301,161
                            
                            
                            
                            5.25
                            
                            
                            
                            0.25
                            
                            
                            
                            1,301,161
                            
                            
                            
                            0.250.85
                            
                            
                            5,604,099
                            
                            
                            
                            5.34
                            
                            
                            
                            0.85
                            
                            
                            
                            5,596,600
                            
                            
                            
                            0.851.35
                            
                            
                            150,000
                            
                            
                            
                            6.56
                            
                            
                            
                            1.35
                            
                            
                            
                            150,000
                            
                            
                            
                            1.352.04
      - 2.11
                            
                            
                            165,000
                            
                            
                            
                            6.25
                            
                            
                            
                            2.07
                            
                            
                            
                            164,583
                            
                            
                            
                            2.072.20
      - 2.48
                            
                            
                            437,917
                            
                            
                            
                            5.93
                            
                            
                            
                            2.27
                            
                            
                            
                            437,917
                            
                            
                            
                            2.2714,485,580
                            
                            
                            
                            
                            
                            
                            
                            
                            
                            
                            
                            11,265,207
  14.
COMMITMENTS AND CONTINGENCIES
 
 The
Company entered into a lease for office and laboratory space in Worcester,
Massachusetts commencing December 2004 and expiring April 2010, and for office
space in Los Angeles, California commencing November 2005 and expiring May 2008.
The Company’s rent at its Los Angeles, California site was on a month-to-month
basis after May 2008. On March 1, 2009, the Company vacated its site in Los
Angeles, California and moved to another site in Los Angeles. The term on this
new lease is through February 28, 2010. Monthly base rent is $2,170. Annual
minimum lease payments are as follows:
  Year
      1
                            
                            $
                            156,800Total
                            
                            $
                            156,800
  Rent
expense recorded in the financial statements for the three months ended
September 30, 2009 and 2008 was approximately $99,000 and $103,000,
respectively. Rent expense recorded in the financial statements for the nine
months ended September 30, 2009 and 2008 was approximately $397,000 and
$825,000, respectively.
 
 On
October 1, 2007 Gary D. Aronson brought suit against the Company with respect to
a dispute over the interpretation of the anti-dilution provisions of our
warrants issued to Mr. Aronson on or about September 14, 2005. John S. Gorton
initiated a similar suit on October 10, 2007.  The two cases have been
consolidated. The plaintiffs allege that we breached warrants to purchase
securities issued by us to these individuals by not timely issuing stock after
the warrants were exercised, failing to issue additional shares of stock in
accordance with the terms of the warrants and failing to provide proper notice
of certain events allegedly triggering Plaintiffs' purported rights to
additional shares.  Plaintiffs assert monetary damages in excess of
$14 million.  Plaintiffs may alternatively seek additional shares in the
Company with a value potentially in excess of $14 million, or may seek a
combination of monetary damages and shares in the Company.  Plaintiffs
also seek prejudgment interest and attorney fees.  Discovery is not
complete and no conclusions have been reached as to the potential exposure to us
or whether we have liability.
 
 The
Company and its subsidiary Mytogen, Inc. are currently defending themselves
against a civil action brought in Suffolk Superior Court, No. 09-442-B, by their
former landlord at 79/96 Thirteenth Street, Charlestown, Massachusetts, a
property vacated by us and Mytogen effective May 31, 2008. In that action,
Alexandria Real Estate-79/96 Charlestown Navy Yard (“ARE”) is alleging that it
has been unable to relet the premises and therefore seeking rent for the vacated
premises since September 2008.  Alexandria is also seeking certain clean-up
and storage expenses.  The Company is defending against the suit, claiming
that ARE had breached the covenant of quiet enjoyment as of when Mytogen
vacated, and that had ARE used reasonable diligence in its efforts to secure a
new tenant, it would have been more successful.  No trial date has been
set. No conclusions have been reached as to the potential exposure to the
Company or whether the Company has a liability.
 
 30
  The
Company has been named as a third party defendant in this action, filed
September 16, 2009, in which the plaintiff alleges that Alexandria Real Estate
(“Alexandria”) improperly charged a trustee holding approximately $146,000 of
funds in a Company account that Bristol claimed as collateral. Alexandria
brought a third party complaint against the Company for indemnification. No
conclusions have been reached as to the potential exposure to the Company or
whether the Company has a liability.
  On March
9, 2009, plaintiffs filed a complaint and summons in the Supreme Court of the
State of New York, County of New York against the Company and its subsidiary
Mytogen, Inc. Plaintiffs’ complaint alleges, among other things, that the
Company has breached the terms of certain contracts with plaintiffs; namely,
convertible debentures and a consulting agreement. Plaintiffs seek preliminary
and permanent injunctive relief directing the Company to deliver to plaintiff
Bristol Investment Fund, Ltd. (“Bristol”) 2.5 million shares of its common
stock, declaring a conversion price of $0.02 for the convertible debentures held
by plaintiffs, and directing the Company to honor plaintiff’s future conversion
requests. Plaintiffs also seek compensatory damages in an amount to be
determined at trial, but alleged in the complaint to exceed $1.5 million. On May
1, 2009, the Company filed an answer to plaintiffs’ complaint. On May 13, 2009,
the Company filed a motion to stay the action and to compel arbitration of all
claims by Bristol. The court has not yet ruled on the Company’s motion to stay
the action and to compel arbitration. On or about September 16, 2009, plaintiffs
filed an order to show cause, seeking the issuance of a preliminary injunction
directing the Company to deliver to Bristol 2.5 shares of its common stock
pursuant to a convertible debenture and 47.4 million shares of its common
stock  pursuant to common stock purchase warrants, declaring a
conversion price of $0.02 for the convertible debenture held by plaintiffs, and
enjoining or restraining the Company from issuing shares of its common stock to
any entity other than plaintiffs or the other holders of convertible debentures.
On September 25, 2009, the Company submitted its response in opposition to
plaintiffs’ motion and moved by cross-motion for dismissal of the complaint,
based on the terms of the consent, waiver, amendment and exchange agreement
entered into between the Company and the holders of over 95% of the outstanding
principal amount of the Amended and Restated Debentures. The court has not yet
ruled on the respective motions. The Company intends to continue to contest the
case vigorously. Management believes the Company will prevail, and accordingly,
the Company did not recognize a liability in its accompanying consolidated
balance sheet at September 30, 2009.
 
 The
Company has entered into employment contracts with certain executives and
research personnel. The contracts provide for salaries, bonuses and stock option
grants, along with other employee benefits. The employment contracts generally
have no set term and can be terminated by either party. There is a provision for
payments of three months to one year of annual salary as severance if we
terminate a contract without cause, along with the acceleration of certain
unvested stock option grants.
 
 15.
INCOME TAXES
 
 The
Company adopted the provisions of FASB ASC 740. FASB ASC 740 prescribes a
recognition threshold and measurement attribute for the financial statement
recognition and measurement of a tax position taken or expected to be taken in a
tax return. FASB ASC 740 also provides guidance on derecognition,
classification, interest and penalties, accounting in interim periods,
disclosure, and transition. Due to the fact that the Company has substantial net
operating loss carryforwards, adoption of FASB ASC 740 had no impact on the
Company’s beginning retained earnings, balance sheets, or statements of
operations.
  The
Company files income tax returns in the U.S. federal jurisdiction, and various
states and foreign jurisdictions. With few exceptions, the Company is no longer
subject to U.S. federal, state and local income tax examinations by tax
authorities for years before 2001.
  31
  The
Company recognizes accrued interest and penalties on unrecognized tax benefits
in income tax expense. The Company did not have any unrecognized tax benefits as
of September 30, 2009 and 2008. As a result, the Company did not recognize
interest expense, and additionally, did not record any penalties during the
three and nine months ended September 30, 2009 and 2008. The Company does not
expect that the amounts of unrecognized tax benefits will change significantly
within the next 12 months.
 
 16. SUBSEQUENT
EVENTS
  The
Company has evaluated subsequent events through the time of filing these
financial statements with the SEC on November 16, 2009.
  On  October
19, 2009, the Company entered into two letter agreements with Volation Life
Sciences Capital Partners, LLC (“Volation”) (See Note 10), pursuant to which (i)
the Company reduced the conversion price of its outstanding Series A-1
convertible preferred stock issued to Volation to $.10 per share resulting in
22,880,000 shares of Common Stock upon conversion, (ii) issued Volation
2,500,000 shares of its Common Stock at $0.10 per share in payment of an
outstanding commitment fee, and (iii) Volation waived the delinquency
in  non-payment of the $250,000 commitment fee required pursuant to
the preferred stock purchase agreement between the Company and
Volation.
  In
connection with an amendment to an agreement between the Company and JMJ
Financial (See Note 6), on October 1, 2009, the Company borrowed $1,000,000 and
issued a convertible promissory note for $1,200,000.  The Company
shall pay a one-time interest payment of 10% of the principal of the promissory
note which is due on the maturity date of the promissory note, which is October
1, 2012.   The promissory note is convertible into shares of the
Company’s common stock at a conversion price of the lesser of (i) $.25 per share
or (ii) eighty percent of the average of the three lowest trade prices in the 20
trading days prior to the conversion.
  In
connection with an amendment to an agreement between the Company and JMJ
Financial (See Note 6), on October 1, 2009, the Company borrowed $1,000,000 and
issued a secured & collateralized promissory note. The Company shall pay a
one-time interest payment of 12% of the principal of the promissory note which
is due on the maturity date of the promissory note, which is October 1,
2012.   The promissory note is secured by $1,000,000 of a money
market fund or other assets of the Company.
  On
November 2, 2009 (“Effective Date”), the Company entered into a preferred stock
purchase agreement with Optimus Life Sciences Capital Partners, LLC
(“Investor”). Pursuant to the purchase agreement:
  ·
              The
      Company agreed to sell, and the Investor agreed to purchase, in one or
      more purchases from time to time (“Tranches”) in the Company’s sole
      discretion (subject to the conditions set forth therein), (i) up to 1,000
      shares of Series B preferred stock (the “Preferred Shares”) at a purchase
      price of $10,000 per share, for an aggregate purchase price of up to
      $10,000,000, and (ii) five-year warrants to purchase shares of the
      Company’s common stock  with an aggregate exercise price equal
      to 135% of the purchase price paid by the Investor, at an exercise price
      per share equal to the closing bid price of the Company’s common stock on
      the date the Company provides notice of such Tranche. The Warrants will be
      issued in replacement of a five-year warrant to purchase 119,469,027
      shares of common stock with an exercise price per share of $0.113 the
      Company issued on the Effective
Date.
  ·
              the
      Company agreed to pay to the Investor a commitment fee of $500,000, at the
      earlier of the closing of the first Tranche or the six month anniversary
      of the effective date, payable at the Company’s election in cash or common
      stock valued at 90% of the volume weighted average price of the Company’s
      common stock on the five trading days preceding the payment
      date.
  ·
              the
      Company agreed to use its best efforts to file within 60 days of the
      effective date, and cause to become effective as soon as possible
      thereafter, a registration statement with the Securities and Exchange
      Commission for the resale of all shares of common stock issuable pursuant
      to the purchase agreement, including the shares of common stock underlying
      the Warrants, and shares issuable in payment of the commitment
      fee.
  32
  ·
              On
      November 3, 2009, the Company filed a certificate of designations for the
      Series B preferred stock (the “Certificate of Designations”). Pursuant to
      the Certificate of Designations, the preferred shares shall, with respect
      to dividend,rights upon
      liquidation, winding-up or dissolution, rank: (i) senior to the Company’s
      common stock, and any other class or series of preferred stock of the
      Company, except Series A-1 Convertible Preferred Stock which shall rank
      senior in right of liquidation and pari passu with respect
      to dividends; and (ii) junior to all existing and future indebtedness of
      the Company. In addition, the preferred shares (a) shall accrue dividends
      at  a rate of 10% per annum, payable in preferred shares, (ii)
      shall  not have voting rights, and (iii) may be redeemed at the
      Company’s option, commencing 4 years from the issuance date at a price per
      share of (a)  $10,000 per share plus accrued but unpaid
      dividends (the “Series B Liquidation Value”), or, at a price per share of
      : (x) 127% of the Series B Liquidation Value if redeemed on or after the
      first anniversary but prior to the second anniversary of the initial
      issuance date, (y) 118% of the Series B Liquidation Value if redeemed on
      or after the second anniversary but prior to the third anniversary of the
      initial issuance date, and (z) 109% of the Series B Liquidation Value if
      redeemed on or after the third anniversary but prior to the fourth
      anniversary of the initial issuance
date.
  On
November 12, 2009, the Company entered into a subscription agreement (the
“Subscription Agreement”) with the subscribers identified on the signature pages
thereto (the “Subscribers”). Pursuant to the Subscription Agreement, the Company
agreed to sell, and the Subscribers agreed to purchase, subject to the terms and
conditions therein, original issue discount promissory notes in the principal
amount of a minimum of $2,400,000, for a purchase price of a minimum of
$2,000,000 (the “Notes”). The Notes will be convertible into shares of the
Company’s common stock at a conversion price of $0.10. Pursuant to the
Subscription Agreement, the Company also agreed to issue (i) one-and-one third
Class A warrants (“Class A Warrants”) for each two shares of common stock
underlying the Notes, to purchase shares of the Company’s common stock with a
term of five years and an exercise price of $0.108, (ii) additional investment
rights, exercisable until 9 months after the initial closing date of the
Subscription Agreement (“Additional Investment Rights”), to purchase (a)
original issue discount promissory notes (“AIR Notes”), with the same terms as
the Notes, in the principal amount of up to the principal amount of the Notes to
be purchased by the Subscribers, for a purchase price of up to the purchase
price paid by the Subscribers for the Notes, with a conversion price of $0.10,
and (b) one-and-one third Class B warrants (“Class B Warrants”) for each two
shares of common stock underlying the AIR Notes, to purchase shares of the
Company’s common stock with a term of five years and an exercise price of
$0.108.
 
 The
Company will be required to redeem the Notes monthly commencing in May 2010, in
the amount of 14.28% of the initial principal amount of the Notes, in cash or
common stock at the Company’s option (subject to the conditions set forth in the
Notes), until the Notes are paid in full.
 
 The
initial closing under the Subscription Agreement occurred on November 12, 2009,
pursuant to which, the Company sold Notes in the principal amount of $1,662,000
for a purchase price of $1,385,000. In addition, on November 13, 2009, the
Company sold Notes in the principal amount of $441,000 for a purchase price of
$367,500 (including $67,500 paid for by forgiveness of legal fees owed to a
subscriber). The closing that occurred on November 13, 2009 was deemed part of
the initial closing, such that, pursuant to the initial closing under the
Subscription Agreement, the Company sold Notes in the aggregate principal amount
of $2,103,000 for an aggregate purchase price of $1,752,500. Pursuant to the
initial closing under the Subscription Agreement, the Company also issued an
aggregate of (i) 14,020,000 Class A Warrants, and (ii) Additional Investment
Rights for the purchase of up to (a) $4,206,000 principal amount of AIR Notes
for a purchase price of up to $3,505,000 and (b) 28,040,000 Class B
Warrants.
 
 The
Subscribers also agreed to purchase, subject to customary conditions, additional
Notes in the principal amount of $2,103,000, for a purchase price of $1,720,000,
in a second closing to occur within 90 days of the initial
closing.
 Immediately
after the initial closing under the Subscription Agreement, the Company had
613,885,468 shares of common stock issued and outstanding.
 33




CAUTIONARY
NOTE REGARDING FORWARD-LOOKING STATEMENTS




This
Quarterly Report on Form 10-Q and the materials incorporated herein by
reference contain forward-looking statements that involve risks and
uncertainties. We use words such as “may,” “assumes,” “forecasts,” “positions,”
“predicts,” “strategy,” “will,” “expects,” “estimates,” “anticipates,”
“believes,” “projects,” “intends,” “plans,” “budgets,” “potential,” “continue”
and variations thereof, and other statements contained in quarterly report, and
the exhibits hereto, regarding matters that are not historical facts and are
forward-looking statements. Because these statements involve risks and
uncertainties, as well as certain assumptions, actual results may differ
materially from those expressed or implied by such forward-looking statements.
Factors that could cause actual results to differ materially include, but are
not limited to risks inherent in:  our early stage of development,
including a lack of operating history, lack of profitable operations and the
need for additional capital; the development and commercialization of largely
novel and unproven technologies and products; our ability to protect, maintain
and defend our intellectual property rights; uncertainties regarding our ability
to obtain the capital resources needed to continue research and development
operations and to conduct research, preclinical development and clinical trials
necessary for regulatory approvals; uncertainty regarding the outcome of
clinical trials and our overall ability to compete effectively in a highly
complex, rapidly developing, capital intensive and competitive industry. See
“RISK FACTORS THAT MAY AFFECT OUR BUSINESS” set forth herein for a more
complete discussion of these factors. Readers are cautioned not to place undue
reliance on these forward-looking statements, which speak only as of the date
that they are made. We undertake no obligation to publicly update or revise any
forward-looking statements, whether as a result of new information, future
events or otherwise.





Forward-looking
statements include our plans and objectives for future operations, including
plans and objectives relating to our products and our future economic
performance. Assumptions relating to the foregoing involve judgments with
respect to, among other things, future economic, competitive and market
conditions, future business decisions, and the time and money required to
successfully complete development and commercialization of our technologies, all
of which are difficult or impossible to predict accurately and many of which are
beyond our control. Although we believe that the assumptions underlying the
forward-looking statements contained herein are reasonable, any of those
assumptions could prove inaccurate and, therefore, we cannot assure you that the
results contemplated in any of the forward-looking statements contained herein
will be realized. Based on the significant uncertainties inherent in the
forward-looking statements included herein, the inclusion of any such statement
should not be regarded as a representation by us or any other person that our
objectives or plans will be achieved.




ITEM
2. 
MANAGEMENT’S DISCUSSION AND ANALYSIS OF FINANCIAL CONDITION AND RESULTS OF
OPERATIONS




OVERVIEW




The
following discussion should be read in conjunction with the financial statements
and notes thereto included in Part I, Item 1 of this Quarterly Report on
Form 10-Q.





We are a
biotechnology company focused on developing and commercializing human stem cell
technology in the emerging fields of regenerative medicine and stem cell
therapy. Principal activities to date have included obtaining financing,
securing operating facilities, and conducting research and development. We have
no therapeutic products currently available for sale and do not expect to have
any therapeutic products commercially available for sale for a period of years,
if at all. These factors indicate that our ability to continue research and
development activities is dependent upon the ability of management to obtain
additional financing as required.




CRITICAL
ACCOUNTING POLICIES




Deferred Issuance
Cost— Payments, either in cash or share-based payments, made in
connection with the sale of debentures are recorded as deferred debt issuance
costs and amortized using the effective interest method over the lives of the
related debentures. The weighted average amortization period for deferred debt
issuance costs is 48 months.




Fair Value
Measurements — For certain financial instruments, including accounts
receivable, accounts payable, accrued expenses, interest payable, advances
payable and notes payable, the carrying amounts approximate fair value due to
their relatively short maturities.





On
January 1, 2008, we adopted FASB ASC 820-10, “Fair Value Measurements and
Disclosures.” FASB ASC 820-10 defines fair value, and establishes a
three-level valuation hierarchy for disclosures of fair value measurement that
enhances disclosure requirements for fair value measures. The carrying amounts
reported in the consolidated balance sheets for receivables and current
liabilities each qualify as financial instruments and are a reasonable estimate
of their fair values because of the short period of time between the origination
of such instruments and their expected realization and their current market rate
of interest. The three levels of valuation hierarchy are defined as
follows:





·
            Level
      1 inputs to the valuation methodology are quoted prices for identical
      assets or liabilities in active
markets.


34





·
            Level
      2 inputs to the valuation methodology include quoted prices for similar
      assets and liabilities in active markets, and inputs that are observable
      for the asset or liability, either directly or indirectly, for
      substantially the full term of the financial
  instrument.





·
            Level
      3 inputs to the valuation methodology are unobservable and significant to
      the fair value measurement.





Management
analyzes all financial instruments with features of both liabilities and equity
under FASB ASC 480, “Distinguishing Liabilities From
Equity”and FASB ASC 815, “Derivatives and Hedging.”Derivative liabilities are adjusted to reflect fair value at each period
end, with any increase or decrease in the fair value being recorded in results
of operations as adjustments to fair value of derivatives. The effects of
interactions between embedded derivatives are calculated and accounted for in
arriving at the overall fair value of the financial instruments. In addition,
the fair values of freestanding derivative instruments such as warrant and
option derivatives are valued using the Black-Scholes model.





Revenue
Recognition— Our revenues are generated from license and research
agreements with collaborators. Licensing revenue is recognized on a
straight-line basis over the shorter of the life of the license or the estimated
economic life of the patents related to the license. Deferred revenue represents
the portion of the license and other payments received that has not been earned.
Costs associated with the license revenue are deferred and recognized over the
same term as the revenue. Reimbursements of research expense pursuant to grants
are recorded in the period during which collection of the reimbursement becomes
assured, because the reimbursements are subject to approval.





Stock Based
Compensation— Effective January 1, 2006, we adopted the fair value
recognition provisions of FASB ASC 718 “Compensation-Stock
Compensation,” using the modified-prospective transition method. Under
this method, stock-based compensation expense is recognized in the consolidated
financial statements for stock options granted, modified or settled after the
adoption date. In accordance with FAS 123(R), the unamortized portion of
options granted prior to the adoption date is recognized into earnings after
adoption. Results for prior periods have not been restated, as provided for
under the modified-prospective method.





Under
FASB ASC 718, stock-based compensation expense recognized is based on the value
of the portion of share-based payment awards that are ultimately expected to
vest during the period. Based on this, our stock-based compensation is reduced
for estimated forfeitures at the time of grant and revised, if necessary, in
subsequent periods if actual forfeitures differ from those
estimates.




Recent
Accounting Pronouncements




In May
2009, the FASB issued SFAS No. 165, “Subsequent Events” (“SFAS
165”) codified in FASB ASC 855-10-05, which provides guidance to establish
general standards of accounting for and disclosures of events that occur after
the balance sheet date but before financial statements are issued or are
available to be issued. FASB ASC 855-10-05 also requires entities to disclose
the date through which subsequent events were evaluated as well as the rationale
for why that date was selected. FASB ASC 855-10-05 is effective for interim and
annual periods ending after June 15, 2009, and accordingly, management adopted
this pronouncement during the second quarter of 2009. FASB ASC 855-10-05
requires that public entities evaluate subsequent events through the date that
the financial statements are issued. Management has evaluated subsequent events
through the time of filing these financial statements with the SEC on November
16, 2009.




In June
2009, the FASB issued SFAS No. 166, “Accounting for Transfers of
Financial Assets — an amendment of FASB Statement No. 140” (“SFAS 166”),
codified as FASB ASC 860, which requires entities to provide more information
regarding sales of securitized financial assets and similar transactions,
particularly if the entity has continuing exposure to the risks related to
transferred financial assets. FASB ASC 860 eliminates the concept of a
“qualifying special-purpose entity,” changes the requirements for derecognizing
financial assets and requires additional disclosures. FASB ASC 860 is effective
for fiscal years beginning after November 15, 2009. The adoption of FASB ASC 860
did not have an impact on our financial condition, results of operations or cash
flows.





In June
2009, the FASB issued SFAS No. 167, “Amendments to FASB Interpretation
No. 46(R)” (“SFAS 167”), codified as FASB ASC 810-10, which modifies how
a company determines when an entity that is insufficiently capitalized or is not
controlled through voting (or similar rights) should be consolidated. FASB ASC
810-10 clarifies that the determination of whether a company is required to
consolidate an entity is based on, among other things, an entity’s purpose and
design and a company’s ability to direct the activities of the entity that most
significantly impact the entity’s economic performance. FASB ASC 810-10 requires
an ongoing reassessment of whether a company is the primary beneficiary of a
variable interest entity. FASB ASC 810-10 also requires additional disclosures
about a company’s involvement in variable interest entities and any significant
changes in risk exposure due to that involvement. FASB ASC 810-10 is effective
for fiscal years beginning after November 15, 2009. The adoption of FASB ASC
810-10 did not have an impact on our financial condition, results of operations
or cash flows.





In June
2009, the FASB issued FASB ASC 105, Generally Accepted Accounting Principles,
which establishes the FASB Accounting Standards Codification as the sole source
of authoritative generally accepted accounting principles. Pursuant to the
provisions of FASB ASC 105, we have updated references to GAAP in our financial
statements issued for the period ended September 30, 2009. The adoption of FASB
ASC 105 did not impact our financial position or results of
operations.


35




RESULTS
OF OPERATIONS




Comparison
of Three Months Ended September 30, 2009 and 2008





Three months ended September 30,
                  
                  
                  Three months ended September 30,2009
                  
                  
                  2008% of
                  
                  
                  
                  
                  
                  % ofAmount
                  
                  
                  Revenue
                  
                  
                  Amount
                  
                  
                  RevenueREVENUE
                  
                  $
                  248,141
                  
                  
                  
                  100.0
                  %
                  
                  $
                  242,195
                  
                  
                  
                  100.0
                  %COST
      OF REVENUE
                  
                  
                  108,049
                  
                  
                  
                  43.5
                  %
                  
                  
                  95,180
                  
                  
                  
                  39.3
                  %GROSS
      PROFIT
                  
                  
                  140,092
                  
                  
                  
                  56.5
                  %
                  
                  
                  147,015
                  
                  
                  
                  60.7
                  %RESEARCH
      AND DEVELOPMENT EXPENSES AND GRANT REIMBURSEMENTS
                  
                  
                  700,818
                  
                  
                  
                  282.4
                  %
                  
                  
                  1,434,896
                  
                  
                  
                  592.5
                  %GENERAL
      AND ADMINSTRATIVE EXPENSES
                  
                  
                  453,561
                  
                  
                  
                  182.8
                  %
                  
                  
                  594,663
                  
                  
                  
                  245.5
                  %LOSS
      ON SETTLEMENT OF LITIGATION
                  
                  
                  110,000
                  
                  
                  
                  44.3
                  %
                  
                  
                  740,849
                  
                  
                  
                  305.9
                  %OTHER
      INCOME (EXPENSE)
                  
                  
                  (79,987
                  )
                  
                  
                  -32.2
                  %
                  
                  
                  (9,978,249
                  )
                  
                  
                  -4119.9
                  %NET
      LOSS
                  
                  $
                  (1,204,274
                  )
                  
                  
                  -485.3
                  %
                  
                  $
                  (12,601,642
                  )
                  
                  
                  -5203.1
                  %





Revenue




Revenue
for the three months ended September 30, 2009 and 2008 was $248,141 and
$242,195, respectively, which represents an increase of $5,946.  These
amounts relate primarily to license fees and royalties collected that are being
amortized over the period of the license granted, and are therefore typically
consistent between periods. The increase in revenue during the three months
ended September 30, 2009, was due to more new licenses being granted during the
year as compared to the three months ended September 30, 2008.





Of the
revenue recognized during the three months ended September 30, 2009, we
recognized $51,470 in license fee revenue from Transition Holdings, Inc. On
December 18, 2008, we entered into a license agreement with Transition for
certain of our non-core technology. Under the agreement, Transition agreed to
acquire a license to the technology for a total of $3.5 million in cash. We are
recognizing revenue from this agreement over its 17-year patent useful
life.




Research
and Development Expenses and Grant Reimbursements




Research
and development expenses (“R&D”) for the three months ended September 30,
2009 and 2008 were $700,818 and $1,434,896, respectively, a decrease of
$734,078.  R&D consists mainly of facility costs, payroll and payroll
related expenses, research supplies and costs incurred in connection with
specific research grants, and for scientific research.  The decline in
R&D expenditures during the three months ended September 30, 2009 as
compared to the same period in 2008 is primarily due to the fact that we have
exercised efforts to reduce our operating expenditures.




Our
research and development expenses consist primarily of costs associated with
basic and pre-clinical research exclusively in the field of human stem cell
therapies and regenerative medicine, with focus on development of our
technologies in cellular reprogramming, reduced complexity applications, and
stem cell differentiation. These expenses represent both pre-clinical
development costs and costs associated with non-clinical support activities such
as quality control and regulatory processes. The cost of our research and
development personnel is the most significant category of expense; however, we
also incur expenses with third parties, including license agreements, sponsored
research programs and consulting expenses.





We do not
segregate research and development costs by project because our research is
focused exclusively on human stem cell therapies as a unitary field of study.
Although we have three principal areas of focus for our research, these areas
are completely intertwined and have not yet matured to the point where they are
separate and distinct projects. The intellectual property, scientists and other
resources dedicated to these efforts are not separately allocated to individual
projects, but rather are conducting our research on an integrated
basis.


36




We expect
that research and development expenses will continue to increase in the
foreseeable future as we add personnel, expand our pre-clinical research, begin
clinical trial activities, and increase our regulatory compliance capabilities.
The amount of these increases is difficult to predict due to the uncertainty
inherent in the timing and extent of progress in our research programs, and
initiation of clinical trials. In addition, the results from our basic research
and pre-clinical trials, as well as the results of trials of similar
therapeutics under development by others, will influence the number, size and
duration of planned and unplanned trials. As our research efforts mature, we
will continue to review the direction of our research based on an assessment of
the value of possible commercial applications emerging from these efforts. Based
on this continuing review, we expect to establish discrete research programs and
evaluate the cost and potential for cash inflows from commercializing products,
partnering with others in the biotechnology or pharmaceutical industry, or
licensing the technologies associated with these programs to third
parties.




We
believe that it is not possible at this stage to provide a meaningful estimate
of the total cost to complete our ongoing projects and bring any proposed
products to market. The use of human embryonic stem cells as a therapy is an
emerging area of medicine, and it is not known what clinical trials will be
required by the FDA in order to gain marketing approval. Costs to complete could
vary substantially depending upon the projects selected for development, the
number of clinical trials required and the number of patients needed for each
study. It is possible that the completion of these studies could be delayed for
a variety of reasons, including difficulties in enrolling patients, delays in
manufacturing, incomplete or inconsistent data from the pre-clinical or clinical
trials, and difficulties evaluating the trial results. Any delay in completion
of a trial would increase the cost of that trial, which would harm our results
of operations. Due to these uncertainties, we cannot reasonably estimate the
size, nature nor timing of the costs to complete, or the amount or timing of the
net cash inflows from our current activities. Until we obtain further relevant
pre-clinical and clinical data, we will not be able to estimate our future
expenses related to these programs or when, if ever, and to what extent we will
receive cash inflows from resulting products.




Grant
reimbursements for the three months ended September 30, 2009 and 2008 were $0
and $0, respectively.  The Company did not receive any grant
reimbursements during the three months ended September 30, 2009 or
2008.




General
and Administrative Expenses




General
and administrative expenses for the three months ended September 30, 2009 and
2008 were $453,561 and $594,663, respectively, a decrease of
$141,102.  This expense decrease was primarily a result of management’s
efforts to reduce costs and streamline operations during the three months ended
September 30, 2009 so that we could move closer to achieving profitability.
General and administrative expenses should continue to slightly decrease over
the short term as we continue to streamline our operations and reduce our costs
until we are able to expand.





Loss
on Settlement





Loss on
settlement for the three months ended September 30, 2009 and 2008 was $110,000
and $740,849, respectively. On July 6, 2009, we settled a lawsuit with an
investor whereby we agreed to provide the investor with an additional $110,000
principal, which is to be upon the same terms and conditions as the original
April 2008 debenture. Accordingly, we recognized a loss on settlement in the
amount of $110,000 during the three months ended September 30, 2009 for the
amount of principal that was added to the April 2008 convertible
debenture.





In
September 2008, we were ordered by the Circuit Court of the Twelfth Judicial
District Court for Sarasosa County, Florida to settle certain past due accounts
payable in the amount of $82,317 due to CEOCast, Inc. for past due investor
relations services. On September 29, 2008, the Company settled this account by
issuing 16,463,302 shares of its common stock. The Company recorded a loss on
settlement of $740,849 in its accompanying statements of operations for the
three months ended September 30, 2008.




Other
Income (Loss)




Other
income (loss) for the three months ended September 30, 2009 and 2008 were
($79,987) and ($9,978,249), respectively, which represents an increase of
$9,898,262 in income. The change in other income (loss) in the three months
ended September 30, 2009, compared to that of the earlier period, relates
primarily to adjustments to loss on extinguishment of convertible debentures and
note, change in fair value of derivatives related to the debt financings,
default interest charges on all debt, and amortization of debt issuance costs
and debt discounts.





On July
29, 2009, we entered into a consent, amendment and exchange agreement with
holders of our outstanding convertible debentures and warrants, which were
issued in private placements in 2005, 2006, 2007 and 2008. We agreed to issue to
each debenture holder in exchange for the holder’s debenture an amended and
restated debenture in a principal amount equal to the principal amount of the
holder’s debenture times 1.35 minus any interest paid thereon. The conversion
price under the amended and restated debentures was reduced to $0.10, subject to
certain customary anti-dilution adjustments. The maturity date under the amended
and restated debentures was extended until December 30, 2010. The amended and
restated debentures bear interest at 12% per annum. Further, we agreed to issue
to each holder in exchange for the holder’s warrants amended and restated
warrants, as well as additional warrants exercisable into 79,076,873 shares of
our common stock for a total of warrants exercisable into 192,172,519 shares of
common stock, both warrants containing a reduced exercise price of $0.10,
subject to certain customary anti-dilution adjustments. The termination date
under the amended and restated warrants was extended until June 30, 2014.
Simultaneously with the signing of this agreement, we and the debenture holders
entered into a standstill and forbearance agreement, whereby the debenture
holders agreed to forbear from exercising their rights and remedies under the
original debentures and transaction documents. During the three months ended
September 30, 2009, we recognized a loss on extinguishment of convertible
debentures of $34,679,545 representing the difference between the fair value of
the amended and restated convertible debentures and the carrying value of the
original 2005, 2006, 2007 and 2008 convertible debentures.


37





On August
25, 2009, we entered into an amendment to our convertible promissory notes with
JMJ Financial, originally executed on February 14, 2008. The note has been
amended as follows:





·
            Note A: The
      original issue discount has been increased by 10%, or $60,000, such that
      the new principal amount is
$660,000.


·
            Note B: The
      original issue discount has been increased by 10%, or $120,000, such that
      the new principal amount is
$1,320,000.





All other
terms and conditions of the original convertible promissory note remain in full
force and effect. During the three months ended September 30, 2009, we
recognized a gain on extinguishment of convertible debentures of $199,418
representing the difference between the fair value of the amended and restated
convertible promissory notes and the carrying value of the original convertible
promissory notes.





Interest
income was $371 and $70 during the three months ended September 30, 2009 and
2008, respectively. Interest income was lower in the three months ended
September 30, 2009 than in the three months ended September 30, 2008 due to the
lower cash balances held in interest-bearing deposits during the periods.
Interest expense was $2,354,537 and $13,740,858 for the three months ended
September 30, 2009 and 2008, respectively, which represents a decrease of
$11,386,321. The decrease in interest expense in the three months ended
September 30, 2009, compared to the earlier period primarily to amortization of
debt discounts and deferred financing costs being recorded during 2008 for all
debentures until their default on August 6, 2008. Therefore, no additional
interest expense arose in 2009 from this amortization until after the
aforementioned debenture and promissory note modifications. Interest expense
during the three months ended September 30, 2009 relates to debenture default
interest through the dates of debenture and promissory note modifications in the
amount of $201,724, and $2,152,813 in amortization of debt discounts and
deferred debt issuance costs.





The gain
on the fair value of derivatives was $36,754,306 and $3,762,539, for the three
months ended September 30, 2009 and 2008, respectively.  The change in
our share price contributed most significantly to the change on the fair value
of derivatives during the three months ended September 30, 2009. In periods when
the share price increases, the derivative securities become more attractive to
exercise or in-the-money, and therefore the value of the derivative liabilities
increases. The opposite is true when the share price decreases.





Net
Loss




Net loss
for the three months ended September 30, 2009 and 2008 was $1,204,274 and
$12,601,642, respectively. The change in loss in each period is the result of
changes to the fair value of derivatives and interest charges related to
convertible debentures, and during the three months ended September 30, 2009 is
offset by the loss on extinguishment of convertible debentures and
note.





38




Comparison
of Nine Months Ended September 30, 2009 and 2008




Nine months ended September 30,
                  
                  
                  Nine months ended September 30,2009
                  
                  
                  2008% of
                  
                  
                  
                  
                  
                  % ofAmount
                  
                  
                  Revenue
                  
                  
                  Amount
                  
                  
                  RevenueREVENUE
                  
                  $
                  785,112
                  
                  
                  
                  100.0
                  %
                  
                  $
                  540,926
                  
                  
                  
                  100.0
                  %COST
      OF REVENUE
                  
                  
                  324,148
                  
                  
                  
                  41.3
                  %
                  
                  
                  406,094
                  
                  
                  
                  75.1
                  %GROSS
      PROFIT
                  
                  
                  460,964
                  
                  
                  
                  58.7
                  %
                  
                  
                  134,832
                  
                  
                  
                  24.9
                  %RESEARCH
      AND DEVELOPMENT EXPENSES AND GRANT REIMBURSEMENTS
                  
                  
                  2,138,843
                  
                  
                  
                  272.4
                  %
                  
                  
                  8,084,149
                  
                  
                  
                  1494.5
                  %GENERAL
      AND ADMINSTRATIVE EXPENSES
                  
                  
                  1,961,195
                  
                  
                  
                  249.8
                  %
                  
                  
                  4,160,601
                  
                  
                  
                  769.2
                  %LOSS
      ON SETTLEMENT OF LITIGATION
                  
                  
                  4,903,949
                  
                  
                  
                  624.6
                  %
                  
                  
                  740,849
                  
                  
                  
                  137.0
                  %OTHER
      INCOME (EXPENSE)
                  
                  
                  (41,097,931
                  )
                  
                  
                  -5234.7
                  %
                  
                  
                  (14,859,951
                  )
                  
                  
                  -2747.1
                  %NET
      INCOME (LOSS)
                  
                  $
                  (49,640,954
                  )
                  
                  
                  -6322.8
                  %
                  
                  $
                  (27,710,718
                  )
                  
                  
                  -5122.8
                  %


Revenue




Revenue
for the nine months ended September 30, 2009 and 2008 was $785,112 and $540,926,
respectively, which represents an increase of $244,186.  These amounts
relate primarily to license fees and royalties collected that are being
amortized over the period of the license granted, and are therefore typically
consistent between periods. The increase in revenue during the nine months ended
September 30, 2009, was due to more new licenses being granted as compared to
the nine months ended September 30, 2008.





Of the
revenue recognized during the nine months ended September 30, 2009, we
recognized $147,058 in license fee revenue from Transition Holdings, Inc. On
December 18, 2008, we entered into a license agreement with Transition for
certain of our non-core technology. Under the agreement, Transition agreed to
acquire a license to the technology for a total of $3.5 million in cash. We are
recognizing revenue from this agreement over its 17-year patent useful
life.





Research
and Development Expenses and Grant Reimbursements




Research
and development expenses (“R&D”) for the nine months ended September 30,
2009 and 2008 were $2,275,683 and $8,189,318, respectively, a decrease of
$5,913,635.  R&D consists mainly of facility costs, payroll and payroll
related expenses, research supplies and costs incurred in connection with
specific research grants, and for scientific research.  The decline in
R&D expenditures during the nine months ended September 30, 2009 as compared
to the same period in 2008 is primarily due to the fact that we closed our
Charlestown, Massachusetts and Alameda, California facilities at the end of May
2008 and have exercised efforts to reduce our operating
expenditures.




Our
research and development expenses consist primarily of costs associated with
basic and pre-clinical research exclusively in the field of human stem cell
therapies and regenerative medicine, with focus on development of our
technologies in cellular reprogramming, reduced complexity applications, and
stem cell differentiation. These expenses represent both pre-clinical
development costs and costs associated with non-clinical support activities such
as quality control and regulatory processes. The cost of our research and
development personnel is the most significant category of expense; however, we
also incur expenses with third parties, including license agreements, sponsored
research programs and consulting expenses.





We do not segregate
research and development costs by project because our research is focused
exclusively on human stem cell therapies as a unitary field of study. Although
we have three principal areas of focus for our research, these areas are
completely intertwined and have not yet matured to the point where they are
separate and distinct projects. The intellectual property, scientists and other
resources dedicated to these efforts are not separately allocated to individual
projects, but rather are conducting our research on an integrated
basis.


39


We expect
that research and development expenses will continue to increase in the
foreseeable future as we add personnel, expand our pre-clinical research, begin
clinical trial activities, and increase our regulatory compliance capabilities.
The amount of these increases is difficult to predict due to the uncertainty
inherent in the timing and extent of progress in our research programs, and
initiation of clinical trials. In addition, the results from our basic research
and pre-clinical trials, as well as the results of trials of similar
therapeutics under development by others, will influence the number, size and
duration of planned and unplanned trials. As our research efforts mature, we
will continue to review the direction of our research based on an assessment of
the value of possible commercial applications emerging from these efforts. Based
on this continuing review, we expect to establish discrete research programs and
evaluate the cost and potential for cash inflows from commercializing products,
partnering with others in the biotechnology or pharmaceutical industry, or
licensing the technologies associated with these programs to third
parties.




We
believe that it is not possible at this stage to provide a meaningful estimate
of the total cost to complete our ongoing projects and bring any proposed
products to market. The use of human embryonic stem cells as a therapy is an
emerging area of medicine, and it is not known what clinical trials will be
required by the FDA in order to gain marketing approval. Costs to complete could
vary substantially depending upon the projects selected for development, the
number of clinical trials required and the number of patients needed for each
study. It is possible that the completion of these studies could be delayed for
a variety of reasons, including difficulties in enrolling patients, delays in
manufacturing, incomplete or inconsistent data from the pre-clinical or clinical
trials, and difficulties evaluating the trial results. Any delay in completion
of a trial would increase the cost of that trial, which would harm our results
of operations. Due to these uncertainties, we cannot reasonably estimate the
size, nature nor timing of the costs to complete, or the amount or timing of the
net cash inflows from our current activities. Until we obtain further relevant
pre-clinical and clinical data, we will not be able to estimate our future
expenses related to these programs or when, if ever, and to what extent we will
receive cash inflows from resulting products.




Grant
reimbursements for the nine months ended September 30, 2009 and 2008 were
$136,840 and $105,169, respectively. The Company received one grant during
the nine months ended September 30, 2009 and one grant during the nine months
ended September 30, 2008, both from the National Institutes of
Health.




General
and Administrative Expenses




General
and administrative expenses for the nine months ended September 30, 2009 and
2008 was $1,961,195 and $4,160,601, respectively, a decrease of
$2,199,406.  This expense decrease was primarily a result of management’s
efforts to reduce costs and streamline operations during the nine months ended
September 30, 2009 so that we could move closer to achieving profitability.
General and administrative expenses should continue to slightly decrease over
the short term as we continue to streamline our operations and reduce our costs
until we are able to expand.





Loss
on Settlement





Loss on
settlement for the nine months ended September 30, 2009 and 2008 were $4,903,949
and $740,849, respectively. During the nine months ended September 30, 2009, we
were ordered by the Circuit Court of the Twelfth Judicial District Court for
Sarasosa County, Florida to settle certain past due accounts payable, for
previous professional services and other operating expenses incurred, by the
issuance of shares of our common stock. During the nine months ended September
30, 2009, we settled $505,199 in accounts payable through the issuance of
39,380,847 shares of our common stock with a value of $5,299,148. Accordingly,
we recorded a loss on settlement of $4,793,949 for the nine months ended
September 30, 2009. Further, on July 6, 2009, we settled a lawsuit with an
investor whereby we agreed to provide the investor with an additional $110,000
principal, which is to be upon the same terms and conditions as the original
April 2008 debenture. Accordingly, we recognized a loss on settlement in the
amount of $110,000 during the three months ended September 30, 2009 for the
amount of principal that was added to the April 2008 convertible
debenture.





In
September 2008, we were ordered by the Circuit Court of the Twelfth Judicial
District Court for Sarasosa County, Florida to settle certain past due accounts
payable in the amount of $82,317 due to CEOCast, Inc. for past due investor
relations services. On September 29, 2008, the Company settled this account by
issuing 16,463,302 shares of its common stock. The Company recorded a loss on
settlement of $740,849 in its accompanying statements of operations for the
three months ended September 30, 2008.




Other
Income (Loss)




Other
income (loss) for the nine months ended September 30, 2009 and 2008 was
($41,097,931) and ($14,859,951), respectively, representing an increase in the
expense of $26,237,980. The change in other income (loss) in the three months
ended September 30, 2009, compared to that of the earlier period, relates
primarily to adjustments to loss on extinguishment of convertible debentures and
note, change in fair value of derivatives related to the debt financings,
default interest charges on all debt, and amortization of debt issuance costs
and debt discounts.





In
connection with the July 29, 2009 consent, amendment and exchange agreement
(mentioned above in the “Other
Income (Loss)” section in our analysis of the three months ended
September 30, 2009 and 2008), during the nine months ended September 30, 2009,
we recognized a loss on extinguishment of convertible debentures of $34,679,545
representing the difference between the fair value of the amended and restated
convertible debentures and the carrying value of the original 2005, 2006, 2007
and 2008 convertible debentures.





In
connection with the August 25, 2009 amendment to the convertible promissory
notes with JMJ Financial, agreement (mentioned above in the “Other Income (Loss)” section
in our analysis of the three months ended September 30, 2009 and 2008), during
the nine months ended September 30, 2009, we recognized a gain on extinguishment
of convertible debentures of $199,418 representing the difference between the
fair value of the amended and restated convertible promissory notes and the
carrying value of the original convertible promissory notes.


40





During
the nine months ended September 30, 2009, we recognized a loss on modification
of debentures in the amount of $1,796,368. This loss arose from a court order
that we allow an investor to convert its 2007 and 2008 debenture balances at
$0.02 per share. The change in fair value immediately after the conversion price
reduction from immediately before the conversion price reduction gave rise to
the loss on modification.





Interest
income was $2,129 and $8,236 during the nine months ended September 30, 2009 and
2008, respectively. Interest income was lower in the nine months ended September
30, 2009 than in the nine months ended September 30, 2008 due to the lower cash
balances held in interest-bearing deposits during the periods. Interest expense
was $3,890,447 and $26,488,148 for the nine months ended September 30, 2009 and
2008, respectively, which represents a decrease of $22,597,701. The decrease in
interest expense in the nine months ended September 30, 2009, compared to the
earlier period primarily to amortization of debt discounts and deferred
financing costs being recorded during 2008 for all debentures until their
default on August 6, 2008. Therefore, no additional interest expense arose in
2009 from this amortization until after the aforementioned debenture and
promissory note modifications. Interest expense during the nine months ended
September 30, 2009 relates to debenture default interest through the dates of
debenture and promissory note modifications in the amount of $1,311,330, and
$2,408,978 in amortization of debt discounts and deferred debt issuance
costs.





The gain
(loss) on the fair value of derivatives was ($788,680) and $11,989,715, for the
nine months ended September 30, 2009 and 2008, respectively.  The
change in our share price contributed most significantly to the change on the
fair value of derivatives during the nine months ended September 30, 2009. In
periods when the share price increases, the derivative securities become more
attractive to exercise or in-the-money, and therefore the value of the
derivative liabilities increases. The opposite is true when the share price
decreases.





Net
Loss




Net loss
for the nine months ended September 30, 2009 and 2008 was $49,640,954 and
$27,710,718, respectively. The change in loss in each period is the result of
loss on extinguishment of convertible debentures and note in 2009, changes to
the fair value of derivatives in 2008 and interest charges related to
convertible debentures in both periods.







LIQUIDITY
AND CAPITAL RESOURCES




Cash
Flows





The
following table sets forth a summary of our cash flows for the periods indicated
below:





Nine months ended September 30,2009
                    
                    
                    2008Net
      cash used in operating activities
                    
                    $
                    (3,059,608
                    )
                    
                    $
                    (3,772,675
                    )Net
      cash used in investing activities
                    
                    
                    (7,538
                    )
                    
                    
                    (174,017
                    )Net
      cash provided by financing activities
                    
                    
                    3,308,000
                    
                    
                    
                    2,790,122Net
      increase (decrease) in cash and cash equivalents
                    
                    
                    240,854
                    
                    
                    
                    (1,156,570
                    )Cash
      and cash equivalents at the end of the period
                    
                    $
                    1,057,758
                    
                    
                    $
                    9,546





Operating
Activities





Our net
cash used in operating activities during the nine months ended September 30,
2009 and 2008 was $3,059,608 and $3,772,675, respectively. Cash used in
operating activities decreased during the current period primarily due to a
decrease in operating expenditures, including reduced expenditures resulting
from the closures in May 2008 of the Alameda, California and Charlestown,
Massachusetts facilities.





Cash
Flows from Investing and Financing Activities





Cash used
in investing activities during the nine months ended September 30, 2009 and 2008
was $7,538 and $174,017, respectively. Our cash used in investing activities
during the nine months ended September 30, 2009 was attributed to payment of a
deposit on our leased space in Los Angeles, California as well as a payment for
the purchase of fixed assets for approximately $5,300. Cash provided by
investing activities during the nine months ended September 30, 2008 was
primarily due to purchases of property and equipment. Cash flows provided by
financing activities during the nine months ended September 30, 2009 was
$3,308,000. During the nine months ended September 30, 2009, we received
$2,288,000 from the issuance of Series A-1 convertible preferred stock, and
$1,020,000 from the issuance of convertible promissory notes. During the nine
months ended September 30, 2008, we made payments of $18,650 on notes and leases
and another $3,660 for issuance costs on a note payable. We also received
proceeds of $600,000 from the issuance of a convertible note payable as well as
$2,182,432 from the issuance of notes payable during the nine months ended
September 30, 2008.





41




We are
financing our operations primarily from the following activities:





·
            On
      December 18, 2008, we entered into a license agreement with an
      Ireland-based investor, Transition Holdings Inc. (“Transition”), for
      certain of our non-core technology. Under the agreement, Transition agreed
      to acquire a license to the technology for $3.5 million in cash. As of
      September 30, 2009, we received the entire $3.5 million in cash under this
      agreement.·
            On
      March 30, 2009, we entered into a license agreement with CHA under which
      we will license our RPE technology, for the treatment of diseases of the
      eye, to CHA for development and commercialization exclusively in Korea. We
      are eligible to receive up to a total of $1.9 million in fees based upon
      the parties achieving certain milestones, including us making an IND
      submission to the US FDA to commence clinical trials in humans using the
      technology. We received an up-front fee under the license in the amount of
      $1,100,000. Under the agreement, CHA will incur all of the cost associated
      with the RPA clinical trials in Korea. The agreement is part of the joint
      venture between the two companies.·
            On
      March 11, 2009, we entered into a $5 million credit facility (“Facility”)
      with a life sciences fund. Under the agreement, the proceeds from the
      Facility must be used exclusively for us to file an investigational new
      drug (“IND”) for our retinal pigment epithelium (“RPE”) program, and will
      allow us to complete both Phase I and Phase II studies in humans. An IND
      is required to commence clinical trials. Under the terms of the agreement,
      we may draw down funds, as needed for clinical development of the RPE
      program, from the investor through the issuance of Series A-1 convertible
      preferred stock. The preferred stock pays dividends, in kind of preferred
      stock, at an annual rate of 10%, matures in four years from the initial
      issuance date, and is convertible into common stock at $0.75 per share. On
      October 19, 2009, we entered into two letter agreements with Volation Life
      Sciences Capital Partners, LLC (“Volation”) (See Note 10), pursuant to
      which (i) the Company reduced the conversion price of its outstanding
      Series A-1 convertible preferred stock issued to Volation to $.10 per
      share resulting in 22,880,000 shares of Common Stock upon conversion, (ii)
      issued Volation 2,500,000 shares of its Common Stock at $0.10 per share in
      payment of an outstanding commitment fee, and (iii) Volation waived the
      delinquency in  non-payment of the $250,000 commitment fee
      required pursuant to the preferred stock purchase agreement between the
      Company and Volation.·
            On
      May 13, 2009, the Company entered into another  license
      agreement with CHA under which the Company will license its proprietary
      “single blastomere technology,” which has the potential to generate stable
      cell lines, including RPE for the treatment of diseases of the eye, for
      development and commercialization exclusively in Korea. We received an
      upfront license fee of $300,000.·
            On
      July 29, 2009, we entered into a consent, amendment and exchange agreement
      with holders of our outstanding convertible debentures and warrants, which
      were issued in private placements in 2005, 2006, 2007 and 2008. We agreed
      to issue to each debenture holder in exchange for the holder’s debenture
      an amended and restated debenture in a principal amount equal to the
      principal amount of the holder’s debenture times 1.35 minus any interest
      paid thereon. The conversion price under the amended and restated
      debentures was reduced to $0.10, subject to certain customary
      anti-dilution adjustments. The maturity date under the amended and
      restated debentures was extended until December 30, 2010. The amended and
      restated debentures bear interest at 12% per annum. Further, we agreed to
      issue to each holder in exchange for the holder’s warrants amended and
      restated warrants, as well as additional warrants exercisable into
      79,076,873 shares of our common stock for a total of warrants exercisable
      into 192,172,519 shares of common stock, both warrants containing a
      reduced exercise price of $0.10, subject to certain customary
      anti-dilution adjustments. The termination date under the amended and
      restated warrants was extended until June 30, 2014. Simultaneously with
      the signing of this agreement, we and the debenture holders entered into a
      standstill and forbearance agreement, whereby the debenture holders agreed
      to forbear from exercising their rights and remedies under the original
      debentures and transaction
documents.


·
                During
      September 2009, we received $1,020,000 under its convertible promissory
      notes with JMJ Financial, originally executed on February 14,
      2008.·
                On  October
      19, 2009, we entered into two letter agreements with Volation Life
      Sciences Capital Partners, LLC (“Volation”),  pursuant to which
      (i) we reduced the conversion price of our outstanding Series A-1
      convertible preferred stock issued to Volation to $.10 per share resulting
      in 22,880,000 shares of Common Stock upon conversion, (ii) issued Volation
      2,500,000 shares of our Common Stock at $0.10 per share in payment of an
      outstanding commitment fee, and (iii) Volation waived the delinquency
      in  non-payment of the $250,000 commitment fee required pursuant
      to the preferred stock purchase agreement between us and
      Volation.·
                In
      connection with an amendment to an agreement between us and JMJ Financial,
      on October 1, 2009, we borrowed $1,000,000 and issued a convertible
      promissory note for $1,200,000.  We shall pay a one-time
      interest payment of 10% of the principal of the promissory note which is
      due on the maturity date of the promissory note, which is October 1,
      2012.   The promissory note is convertible into shares of
      our common stock at a conversion price of the lesser of (i) $.25 per share
      or (ii) eighty percent of the average of the three lowest trade prices in
      the 20 trading days prior to the conversion.·
                In
      connection with an amendment to an agreement between us and JMJ Financial,
      on October 1, 2009, we borrowed $1,000,000 and issued a secured &
      collateralized promissory note. We shall pay a one-time interest payment
      of 12% of the principal of the promissory note which is due on the
      maturity date of the promissory note, which is October 1,
      2012.·
                On
      November 2, 2009 (“Effective Date”), we entered into a preferred stock
      purchase agreement with Optimus Life Sciences Capital Partners, LLC
      (“Investor”). Pursuant to the purchase agreement, we agreed to sell, and
      the Investor agreed to purchase, in one or more purchases from time to
      time (“Tranches”) in our sole discretion (subject to the conditions set
      forth therein), (i) up to 1,000 shares of Series B preferred stock (the
      “Preferred Shares”) at a purchase price of $10,000 per share, for an
      aggregate purchase price of up to $10,000,000, and (ii) five-year warrants
      to purchase shares of our common stock  with an aggregate
      exercise price equal to 135% of the purchase price paid by the Investor,
      at an exercise price per share equal to the closing bid price of our
      common stock on the date we provide notice of such Tranche. The Warrants
      will be issued in replacement of a five-year warrant to purchase
      119,469,027 shares of common stock with an exercise price per share of
      $0.113 we issued on the Effective
Date.
 ·
                On
      November 12, 2009, we entered into a subscription agreement (the
      “Subscription Agreement”) with the subscribers (the “Subscribers”).
      Pursuant to the subscription agreement, we agreed to sell, and the
      subscribers agreed to purchase, subject to the terms and conditions
      therein, promissory notes in the principal amount of a minimum of
      $2,400,000, for a purchase price of a minimum of $2,000,000 (the “Notes”).
      The Notes will be convertible into shares of our common stock at a
      conversion price of $0.10. The initial closing under the Subscription
      Agreement occurred on November 12, 2009, pursuant to which, we sold Notes
      in the principal amount of $1,662,000, for a purchase price of $1,385,000,
      and issued 11,080,000 Class A Warrants and Additional Investment Rights
      for the purchase of (a) up to $3,324,000 principal amount of AIR Notes for
      a purchase price of up to $2,770,000 and (b) up to 22,160,000 Class B
      Warrants. In addition, on November 13, 2009, we sold Notes in the
      principal amount of $441,000 for a purchase price of $367,500 (including
      $67,500 paid for in forgiveness of legal fees owed to a subscriber) and
      issued Additional Investment Rights for the purchase of (a) up to $882,000
      principal amount of Notes for a purchase price of up to $735,000 and (b)
      up to 5,880,000 Class B Warrants. The closing that occurred on November
      13, 2009 was deemed part of the initial closing.


To a
substantially lesser degree, financing of our operations is provided through
grant funding, payments received under license agreements, and interest earned
on cash and cash equivalents.




With the
exception of 2002, when we sold certain assets of a subsidiary resulting in a
gain for the year, we have incurred substantial net losses each year since
inception as a result of research and development and general and administrative
expenses in support of our operations. We anticipate incurring substantial net
losses in the future.




Our cash
and cash equivalents are limited. In the short term, we will require substantial
additional funding prior to September 30, 2010 in order to maintain our current
level of operations.  If we are unable to raise additional funding, we will
be forced to either substantially scale back our business operations or curtail
our business operations entirely.




On a
longer term basis, we have no expectation of generating any meaningful revenues
from our product candidates for a substantial period of time and will rely on
raising funds in capital transactions to finance our research and development
programs.  Our future cash requirements will depend on many factors,
including the pace and scope of our research and development programs, the costs
involved in filing, prosecuting and enforcing patents, and other costs
associated with commercializing our potential products. We intend to seek
additional funding primarily through public or private financing transactions,
and, to a lesser degree, new licensing or scientific collaborations, grants from
governmental or other institutions, and other related transactions.  If we
are unable to raise additional funds, we will be forced to either scale back or
business efforts or curtail our business activities entirely.  We
anticipate that our available cash and expected income will be sufficient to
finance most of our current activities for at least four months from the date we
file these financial statements, although certain of these activities and
related personnel may need to be reduced.  We cannot assure you that public
or private financing or grants will be available on acceptable terms, if at
all.  Several factors will affect our ability to raise additional funding,
including, but not limited to, the volatility of our Common
Stock.


42





RISK
FACTORS THAT MAY AFFECT OUR BUSINESS





Our
business is subject to various risks, included but not limited to those
described below. You should carefully consider these factors, together with all
the other information disclosed in this Quarterly Report on Form 10-Q. Any
of these risks could materially adversely affect our business, operating results
and financial condition.





43




Risks
Relating to the Company’s Early Stage Development





We may not be able to continue as a
going concern. Our consolidated financial statements have been prepared
on a going concern basis, which contemplates the realization of assets and the
satisfaction of liabilities in the normal course of business. We have a history
of operating losses that are likely to continue in the future. Our auditors have
included an explanatory paragraph in their Report of Independent Registered
Public Accounting Firm included in our audited consolidated financial statements
for the years ended December 31, 2008 and 2007 to the effect that our
significant losses from operations and our dependence on equity and debt
financing raise substantial doubt about our ability to continue as a going
concern. Our consolidated financial statements do not include any adjustments
that might be necessary should we be unable to continue as a going
concern.





Our business is at an early stage of
development and we may not develop therapeutic products that can be
commercialized. We do not yet have any product candidates in late-stage
clinical trials or in the marketplace. Our potential therapeutic products will
require extensive preclinical and clinical testing prior to regulatory approval
in the United States and other countries. We may not be able to obtain
regulatory approvals (see REGULATORY RISKS), enter clinical trials for any of
our products, or commercialize any products. Our therapeutic and product
candidates may prove to have undesirable and unintended side effects or other
characteristics adversely affecting their safety, efficacy or cost-effectiveness
that could prevent or limit their use. Any product using any of our technology
may fail to provide the intended therapeutic benefits, or achieve therapeutic
benefits equal to or better than the standard of treatment at the time of
testing or production. In addition, we will need to determine whether any of our
potential products can be manufactured in commercial quantities or at an
acceptable cost. Our efforts may not result in a product that can be or will be
marketed successfully. Physicians may not prescribe our products, and patients
or third party payors may not accept our products. For these reasons we may not
be able to generate revenues from commercial production.





We have limited clinical testing,
regulatory, manufacturing, marketing, distribution and sales capabilities which
may limit our ability to generate revenues. Due to the relatively early
stage of our therapeutic products, regenerative medical therapies and stem cell
therapy-based programs, we have not yet invested significantly in regulatory,
manufacturing, marketing, distribution or product sales resources.  We
cannot assure you that we will be able to invest or develop any of these
resources successfully or as expediently as necessary. The inability to do so
may inhibit or harm our ability to generate revenues or operate
profitably.





We have limited capital resources and
we may not obtain the significant additional capital required to sustain our
research and development efforts. We will need additional capital to
conduct our operations and develop our products and our ability to obtain the
necessary funding is uncertain. (see FINANCIAL RISKS) We have losses from
operations, negative cash flows from operations and a substantial stockholders’
deficit and we do not believe that our cash from all sources (including cash,
cash equivalents, anticipated revenues from licensing fees and sponsored
research contracts) is sufficient for us to continue operations beyond December
31, 2009.





Management
continues to evaluate alternatives and sources of additional funding. These may
include public and private investors, strategic partners, and grant programs
available through specific states of foundations. However, there is no assurance
that such sources will result in raising additional capital. Lack of necessary
funding may require us to delay, scale back or eliminate some or all of our
research and product development programs and/or capital expenditures, to
license our potential products or technologies to third parties, to consider
business combinations related to ongoing business operations, or to shut down
some, or all, of our operations.





Additionally,
our cash requirements may vary materially from our current projections due to
unforeseen and unexpected results in product research and development, or
changes in any of the following: potential relationships with strategic
partners, the focus and direction of our research and development programs, the
competitive landscape, litigation required to protect our technology,
technological advances, the cost of pre-clinical and clinical testing, the
regulatory process of the FDA (and of foreign regulators), among others. Our
current cash reserves are not sufficient to fund our operations through the
commercialization of our first products and/or services.





We have a history of operating losses
and we may not achieve future revenues or operating profits. We have
generated modest revenue to date from our operations. Historically we have had
net operating losses each year since our inception.  We have limited
current potential sources of income from licensing fees and the Company does not
generate significant revenue outside of licensing non-core technologies.
Additionally, even if we are able to commercialize our technologies or any
products or services related to our technologies it is not certain that they
will result in revenue or profitability.





We are in the Early Stages of a
Strategic Joint Venture which may slow, impede or result in the termination of
potential therapeutic products whose development is now the responsibility of
the partnership and not solely of the Company. The Company
has entered into a new partnership (CHA) and as a result, we are subject to 3
rd
party interests (see RISKS RELATED TO THIRD PARTY RELIANCE) and control issues,
not the least of which relates to certain of our employees no longer being
exclusively managed by us. We therefore could be at risk for losing key
employees. Additionally substantial operating and working capital will be
required and there is no assurance that CHA Biotech Co. limited, partner in our
joint venture, will be able to fund their requirements.


44





We have a limited operating history
on which investors may evaluate our operations and prospects for profitable
operations. If we continue to suffer losses as we have in the past,
investors may not receive any return on their investment and may their entire
investment. Our prospects must be considered speculative in light of the risks,
expenses and difficulties frequently encountered by companies in their early
stages of development, particularly in light of the uncertainties relating to
the new, competitive and rapidly evolving markets in which we anticipate we will
operate. To attempt to address these risks, we must, among other things, further
develop our technologies, products and services, successfully implement our
research, development, marketing and commercialization strategies, respond to
competitive developments and attract, retain and motivate qualified personnel. A
substantial risk is involved in investing in us because, as an early stage
company we have fewer resources than an established company, our management may
be more likely to make mistakes at such an early stage, and we may be more
vulnerable operationally and financially to any mistakes that may be made, as
well as to external factors beyond our control.




Risks
Relating to Technology





We are dependent on new and unproven
technologies. Our risks as an early stage company are compounded by our
heavy dependence on emerging and sometimes unproven technologies. If these
technologies do not produce satisfactory results, our business may be harmed.
Additionally some of our technologies and significant potential revenue sources
involve ethically sensitive and controversial issues which could become the
subject of legislation or regulations that could materially restrict our
operations and, therefore, harm our financial condition, operating results and
prospects for bringing our investors a return on their investment.





Over the last twelve months we have
narrowed our potential product pool to focusing on our Retinal Program as well
as the applications of our I.P.S. technology, which will limit our revenue
sources. Our human embryonic stem cell and regenerative medical therapy
programs are in the pre-clinical stage and the Company doesn’t foresee having a
commercial product until clinical trials are completed. We have identified the
programs that we are working to get into the clinical testing phase. We have
narrowed the scope of our developmental focus to our Retinal Program and those
related therapies, focusing our products related to our I.P.S. technology and,
as part of our recently established partnership with CHA, developing products in
the Hemangioblast/immunology arena. As a result of our narrower product focus,
we have fewer revenue sources. Our emphasis on fewer programs may hinder our
results if these programs are not successful. Although our adult stem cell
myoblast program has completed Phase I and Ib FDA clinical trials we have
suspended that program indefinitely due to a lack of funding in the cardiac
area.  As a result
of our emphasis on our retinal program, our hemangioblast program and our IPS
technology, our ability to progress as a company is more significantly hinged on
the success of fewer programs and thus, a setback or adverse development
relating to any one of them could potentially have a significant impact on share
price as well as an inhibitory effect on our ability to raise additional
capital. 
Additionally, we partially rely on nuclear transfer and embryonic stem cell and
myoblast technologies that we may not be able to successfully develop, which
will prevent us from generating revenues, operating profitably or providing
investors any return on their investment. (Note that the Myoblast program has
been put on hold indefinitely due to a lack of funding for the next stage of
Clinical trials) 
We cannot guarantee that we will be able to successfully develop our Retinal,
hemangioblast, IPS-related technologies, nuclear transfer technology, embryonic
stem cell or myoblast technologies or that such development will result in
products or services with any significant commercial utility. We anticipate that
the commercial sale of such products or services, and royalty/licensing fees
related to our technology, would be our primary sources of revenues. If we are
unable to develop our technologies, investors will likely lose their entire
investment in us.





We may not be able to commercially
develop our technologies and proposed product lines, which, in turn, would
significantly harm our ability to earn revenues and result in a loss of
investment. Our ability to commercially develop our technologies will be
dictated in large part by forces outside our control which cannot be predicted,
including, but not limited to, general economic conditions, the success of our
research and pre-clinical and field testing, the availability of collaborative
partners to finance our work in pursuing applications of nuclear transfer
technology and technological or other developments in the biomedical field
which, due to efficiencies, technological breakthroughs or greater acceptance in
the biomedical industry, may render one or more areas of commercialization more
attractive, obsolete or competitively unattractive. It is possible that one or
more areas of commercialization will not be pursued at all if a collaborative
partner or entity willing to fund research and development cannot be located.
Our decisions regarding the ultimate products and/or services we pursue could
have a significant adverse affect on our ability to earn revenue if we
misinterpret trends, underestimate development costs and/or pursue wrong
products or services. Any of these factors either alone or in concert could
materially harm our ability to earn revenues or could result in a loss of any
investment in us.





If we are unable to keep up with
rapid technological changes in our field or compete effectively, we will be
unable to operate profitably. We are engaged in activities in the
biotechnology field, which is characterized by extensive research efforts and
rapid technological progress. If we fail to anticipate or respond adequately to
technological developments, our ability to operate profitably could suffer. We
cannot assure you that research and discoveries by other biotechnology,
agricultural, pharmaceutical or other companies will not render our technologies
or potential products or services uneconomical or result in products superior to
those we develop or that any technologies, products or services we develop will
be preferred to any existing or newly-developed technologies, products or
services.





Risks
Related to Intellectual Property





Our business is highly dependent upon
maintaining licenses with respect to key technology. Several of the key
patents we utilize are licensed to us by third parties. These licenses are
subject to termination under certain circumstances (including, for example, our
failure to make minimum royalty payments or to timely achieve development and
commercialization benchmarks). The loss of any of such licenses, or the
conversion of such licenses to non-exclusive licenses, could harm our operations
and/or enhance the prospects of our competitors.


45





Certain
of these licenses also contain restrictions, such as limitations on our ability
to grant sublicenses that could materially interfere with our ability to
generate revenue through the licensing or sale to third parties of important and
valuable technologies that we have, for strategic reasons, elected not to pursue
directly. The possibility exists that in the future we will require further
licenses to complete and/or commercialize our proposed products. We cannot
assure you that we will be able to acquire any such licenses on a commercially
viable basis.





Certain of our technology is not
protectable by patent. Certain parts of our know-how and technology are
not patentable. To protect our proprietary position in such know-how and
technology, we intend to require all employees, consultants, advisors and
collaborators to enter into confidentiality and invention ownership agreements
with us. We cannot assure you, however, that these agreements will provide
meaningful protection for our trade secrets, know-how or other proprietary
information in the event of any unauthorized use or disclosure. Further, in the
absence of patent protection, competitors who independently develop
substantially equivalent technology may harm our business.





Patent litigation presents an ongoing
threat to our business with respect to both outcomes and costs. We have
previously been involved in patent interference litigation, and it is possible
that further litigation over patent matters with one or more competitors could
arise. We could incur substantial litigation or interference costs in defending
ourselves against suits brought against us or in suits in which we may assert
our patents against others. If the outcome of any such litigation is
unfavorable, our business could be materially adversely affected. To determine
the priority of inventions, we may also have to participate in interference
proceedings declared by the United States Patent and Trademark Office, which
could result in substantial cost to us. Without additional capital, we may not
have the resources to adequately defend or pursue this litigation.





We may not be able to protect our
proprietary technology, which could harm our ability to operate
profitably.    The biotechnology and pharmaceutical
industries place considerable importance on obtaining patent and trade secret
protection for new technologies, products and processes. Our success will
depend, to a substantial degree, on our ability to obtain and enforce patent
protection for our products, preserve any trade secrets and operate without
infringing the proprietary rights of others. We cannot assure you
that:


-
              we will succeed in obtaining any
      patents in a timely manner or at all, or that the breadth or degree of
      protection of any such patents will protect our
      interests,
 -
              the use of our technology will
      not infringe on the proprietary rights of
  others,
 -
              patent applications relating to
      our potential products or technologies will result in the issuance of any
      patents or that, if issued, such patents will afford adequate protection
      to us or not be challenged invalidated or infringed,
      and
 -
              patents will not issue to other
      parties, which may be infringed by our potential products or
      technologies.




We are
aware of certain patents that have been granted to others and certain patent
applications that have been filed by others with respect to nuclear transfer
technologies. The fields in which we operate have been characterized by
significant efforts by competitors to establish dominant or blocking patent
rights to gain a competitive advantage, and by considerable differences of
opinion as to the value and legal legitimacy of competitors' purported patent
rights and the technologies they actually utilize in their
businesses.





Patents obtained by other persons may
result in infringement claims against us that are costly to defend and which may
limit our ability to use the disputed technologies and prevent us from pursuing
research and development or commercialization of potential products. A
number of other pharmaceutical, biotechnology and other companies, universities
and research institutions have filed patent applications or have been issued
patents relating to cell therapies, stem cells, and other technologies
potentially relevant to or required by our expected products. We cannot predict
which, if any, of such applications will issue as patents or the claims that
might be allowed. We are aware that a number of companies have filed
applications relating to stem cells. We are also aware of a number of patent
applications and patents claiming use of stem cells and other modified cells to
treat disease, disorder or injury.





If third
party patents or patent applications contain claims infringed by either our
licensed technology or other technology required to make and use our potential
products and such claims are ultimately determined to be valid, there can be no
assurance that we would be able to obtain licenses to these patents at a
reasonable cost, if at all, or be able to develop or obtain alternative
technology. If we are unable to obtain such licenses at a reasonable cost, we
may not be able to develop some products commercially. We may be required to
defend ourselves in court against allegations of infringement of third party
patents. Patent litigation is very expensive and could consume substantial
resources and create significant uncertainties. And adverse outcome in such a
suit could subject us to significant liabilities to third parties, require
disputed rights to be licensed from third parties, or require us to cease using
such technology.





We are not in full compliance with
some of our license agreements. We are not in full compliance
with some of our licenses and due to limited financial resources we cannot
guarantee that we will regain full compliance status. If we are unable to be in
compliance with our license agreements, our business may be
harmed.


46




We may not be able to adequately
defend against piracy of intellectual property in foreign jurisdictions.
Considerable research in the areas of stem cells, cell therapeutics and
regenerative medicine is being performed in countries outside of the United
States, and a number of potential competitors are located in these countries.
The laws protecting intellectual property in some of those countries may not
provide adequate protection to prevent our competitors from misappropriating our
intellectual property. Several of these potential competitors may be further
along in the process of product development and also operate large,
company-funded research and development programs. As a result, our competitors
may develop more competitive or affordable products, or achieve earlier patent
protection or product commercialization than we are able to achieve. Competitive
products may render any products or product candidates that we develop
obsolete.




Regulatory
Risks





We cannot market our product
candidates until we receive regulatory approval. We must comply with
extensive government regulations in order to obtain and maintain marketing
approval for our products in the United States and abroad. The process of
obtaining regulatory approval is lengthy, expensive and uncertain. In the United
States, the FDA imposes substantial requirements on the introduction of
biological products and many medical devices through lengthy and detailed
laboratory and clinical testing procedures, sampling activities and other costly
and time-consuming procedures. Satisfaction of these requirements typically
takes several years and the time required to do so may vary substantially based
upon the type and complexity of the biological product or medical
device.





In
addition, product candidates that we believe should be classified as medical
devices for purposes of the FDA regulatory pathway may be determined by the FDA
to be biologic products subject to the satisfaction of significantly more
stringent requirements for FDA approval. Any difficulties that we encounter in
obtaining regulatory approval may have a substantial adverse impact on our
business and cause our stock price to significantly decline.





We cannot assure you that we will
obtain FDA or foreign regulatory approval to market any of our product
candidates for any indication in a timely manner or at all. If we fail to
obtain regulatory approval of any of our product candidates for at least one
indication, we will not be permitted to market our product candidates and may be
forced to cease our operations.





Even if some of our product
candidates receive regulatory approval, these approvals may be subject to
conditions, and we and our third party manufacturers will in any event be
subject to significant ongoing regulatory obligations and oversight. Even
if any of our product candidates receives regulatory approval, the
manufacturing, marketing and sale of our product candidates will be subject to
stringent and ongoing government regulation. Conditions of approval, such as
limiting the category of patients who can use the product, may significantly
impact our ability to commercialize the product and may make it difficult or
impossible for us to market a product profitably. Changes we may desire to make
to an approved product, such as cell culturing changes or revised labeling, may
require further regulatory review and approval, which could prevent us from
updating or otherwise changing an approved product. If our product candidates
are approved by the FDA or other regulatory authorities for the treatment of any
indications, regulatory labeling may specify that our product candidates be used
in conjunction with other therapies.





Once obtained, regulatory approvals
may be withdrawn and can be expensive to maintain. Regulatory approval
may be withdrawn for a number of reasons, including the later discovery of
previously unknown problems with the product. Regulatory approval may also
require costly post-marketing follow-up studies, and failure of our product
candidates to demonstrate sufficient efficacy and safety in these studies may
result in either withdrawal of marketing approval or severe limitations on
permitted product usage. In addition, numerous additional regulatory
requirements relating to, among other processes, the labeling, packaging,
adverse event reporting, storage, advertising, promotion and record-keeping will
also apply. Furthermore, regulatory agencies subject a marketed product, its
manufacturer and the manufacturer's facilities to continual review and periodic
inspections. Compliance with these regulatory requirements are time consuming
and require the expenditure of substantial resources.





If any of
our product candidates is approved, we will be required to report certain
adverse events involving our products to the FDA, to provide updated safety and
efficacy information and to comply with requirements concerning the
advertisement and promotional labeling of our products. As a result, even if we
obtain necessary regulatory approvals to market our product candidates for any
indication, any adverse results, circumstances or events that are subsequently
discovered, could require that we cease marketing the product for that
indication or expend money, time and effort to ensure full compliance, which
could have a material adverse effect on our business.





If our products do not comply with
applicable laws and regulations our business will be harmed.
Any failure by us, or by any third parties that may manufacture or market our
products, to comply with the law, including statutes and regulations
administered by the FDA or other U.S. or foreign regulatory authorities, could
result in, among other things, warning letters, fines and other civil penalties,
suspension of regulatory approvals and the resulting requirement that we suspend
sales of our products, refusal to approve pending applications or supplements to
approved applications, export or import restrictions, interruption of
production, operating restrictions, closure of the facilities used by us or
third parties to manufacture our product candidates, injunctions or criminal
prosecution. Any of the foregoing actions could have a material adverse effect
on our business.


47





Our products may not be accepted in
the marketplace .   If we are successful in obtaining
regulatory approval for any of our product candidates, the degree of market
acceptance of those products will depend on many factors,
including:





-
              Our ability to provide acceptable
      evidence and the perception of patients and the healthcare community,
      including third party payors, of the positive characteristics of our
      product candidates relative to existing treatment methods, including their
      safety, efficacy, cost effectiveness and/or other potential
      advantages,
 -
              The incidence and severity of any
      adverse side effects of our product
  candidates,
 -
              The availability of alternative
      treatments,
 -
              The labeling requirements imposed
      by the FDA and foreign regulatory agencies, including the scope of
      approved indications and any safety
  warnings,
 -
              Our ability to obtain sufficient
      third party insurance coverage or reimbursement for our products
      candidates,
 -
              The inclusion of our products on
      insurance company coverage
policies,
 -
              The willingness and ability of
      patients and the healthcare community to adopt new
      technologies,
 -
              The procedure time associated
      with the use of our product
candidates,
 -
              Our ability to manufacture or
      obtain from third party manufacturers sufficient quantities of our product
      candidates with acceptable quality and at an acceptable cost to meet
      demand, and
 -
              Marketing and distribution
      support for our
products.





We cannot
predict or guarantee that physicians, patients, healthcare insurers, third party
payors or health maintenance organizations, or the healthcare community in
general, will accept or utilize any of our product candidates.  Failure to
achieve market acceptance would limit our ability to generate revenue and would
have a material adverse effect on our business. In addition, if any of our
product candidates achieve market acceptance, we may not be able to maintain
that market acceptance over time if competing products or technologies are
introduced that are received more favorably or are more
cost-effective.





Risks
Related to Domestic Governmental Regulation




Companies such as ours engaged in
research using embryonic stem cells, adult stem cells and IPS technology are
currently subject to strict government regulations, and our operations could be
harmed by any legislative or administrative efforts impacting the use of nuclear
transfer technology or human embryonic material.   We cannot
assure you that our operations will not be harmed by any legislative or
administrative efforts by politicians or groups opposed to the development of
I.P.S. (Induced Pluripotent Stem Cell) technology generally or the use of IPS
technology in the development of therapies specifically. Further, we cannot
assure you that legislative or administrative restrictions directly or
indirectly delaying, limiting or preventing the use of IPS in the development of
products or human embryonic material or the sale, manufacture or use of products
or services derived from IPS or human embryonic material will not be adopted in
the future.




Restrictions on the use of human
embryonic stem cells, and the ethical, legal and social implications of that
research, could prevent us from developing or gaining acceptance for
commercially viable products in these areas. Some of our most important
programs involve the use of stem cells that are derived from human embryos. The
use of human embryonic stem cells gives rise to ethical, legal and social issues
regarding the appropriate use of these cells. In the event that our research
related to human embryonic stem cells becomes the subject of adverse commentary
or publicity, the market price for our common stock could be significantly
harmed. Some political and religious groups have voiced opposition to our
technology and practices. We use stem cells derived from human embryos that have
been created for in vitro fertilization procedures but are no longer desired or
suitable for that use and are donated with appropriate informed consent for
research use. Many research institutions, including some of our scientific
collaborators, have adopted policies regarding the ethical use of human
embryonic tissue. These policies may have the effect of limiting the scope of
research conducted using human embryonic stem cells, thereby impairing our
ability to conduct research in this field.





Despite the rescission of the
President Bush’s Exec order in August 2001 by President Barak Obama in March
2009, the overall effect of new laws drafted by the NIH and put into effect
regarding the dropping of restrictions on hES research has yet to be seen or
made clear. While it is unclear whether Federal law continues to restrict
the use of federal funds for human embryonic cell research, commonly referred to
as hES cell research, there can be no assurance that our operations will not be
restricted by any future legislative or administrative efforts by politicians or
groups opposed to the development of hES call technology or nuclear transfer
technology. Additionally there are no allowances made addressing the legality of
therapies resulting from IPS technology. Additionally the executive order does
not overturn the Dickey–Wicker Amendment, a 13-year-old ban on federal funding
for the actual creation of new stem cell lines, an act that destroys an embryo.
In the United States these efforts still must be funded privately or by state
governments. Further, there can be no assurance that legislative or
administrative restrictions directly or indirectly delaying, limiting or
preventing the use of hES technology, nuclear transfer technology, IPS
technology, the use of human embryonic material, or the sale, manufacture or use
of products or services derived from nuclear transfer technology or other hES
technology will not be adopted or extended in the future.


48


Because we or our collaborators must
obtain regulatory approval to market our products in the United States and other
countries, we cannot predict whether or when we will be permitted to
commercialize our products.   Federal, state and local
governments in the United States and governments in other countries have
significant regulations in place that govern many of our activities. We are or
may become subject to various federal, state and local laws, regulations and
recommendations relating to safe working conditions, laboratory and
manufacturing practices, the experimental use of animals and the use and
disposal of hazardous or potentially hazardous substances used in connection
with our research and development work. The preclinical testing and clinical
trials of the products that we or our collaborators develop are subject to
extensive government regulation that may prevent us from creating commercially
viable products from our discoveries. In addition, the sale by us or our
collaborators of any commercially viable product will be subject to government
regulation from several standpoints, including manufacturing, advertising and
promoting, selling and marketing, labeling, and distributing.




If, and
to the extent that, we are unable to comply with these regulations, our ability
to earn revenues will be materially and negatively impacted. The regulatory
process, particularly in the biotechnology field, is uncertain, can take many
years and requires the expenditure of substantial resources. Biological drugs
and non-biological drugs are rigorously regulated. In particular, proposed human
pharmaceutical therapeutic product candidates are subject to rigorous
preclinical and clinical testing and other requirements by the FDA in the United
States and similar health authorities in other countries in order to demonstrate
safety and efficacy. We may never obtain regulatory approval to market our
proposed products. For additional information about governmental regulations
that will affect our planned and intended business operations, see "DESCRIPTION
OF BUSINESS— Government
Regulation " above.




Our products may not receive FDA
approval, which would prevent us from commercially marketing our products and
producing revenues. The FDA and comparable government agencies in foreign
countries impose substantial regulations on the manufacture and marketing of
pharmaceutical products through lengthy and detailed laboratory, pre-clinical
and clinical testing procedures, sampling activities and other costly and
time-consuming procedures. Satisfaction of these regulations typically takes
several years or more and varies substantially based upon the type, complexity
and novelty of the proposed product. We cannot assure you that FDA approvals for
any products developed by us will be granted on a timely basis, if at all. Any
such delay in obtaining, or failure to obtain, such approvals could have a
material adverse effect on the marketing of our products and our ability to
generate product revenue. For additional information about governmental
regulations that will affect our planned and intended business operations, see
"DESCRIPTION OF BUSINESS— Government Regulation "
above.




For-profit entities may be prohibited
from benefiting from grant funding. There has been much publicity about
grant resources for stem cell research, including Proposition 71 in
California, which is described more fully under the heading "DESCRIPTION OF
BUSINESS— California
Proposition 71 " above. Recent developments regarding the State of
California deep and significant financial problems has had a direct and
significant impact on the availability of funds: funding commitments have not
been met by CIRM and there is no guarantee that any funds will flow to
for-profit institutions as most of it will go to state and not-for-profit
institutions. Additionally state Rules and regulations related to any funding
that may ultimately be provided, the type of entity that will be eligible for
funding, the science to be funded, and funding details have not been finalized.
As a result of these uncertainties regarding Proposition 71, we cannot
assure you that funding, if any, will be available to us, or any for-profit
entity.




The government maintains certain
rights in technology that we develop using government grant money and we may
lose the revenues from such technology if we do not commercialize and utilize
the technology pursuant to established government guidelines. Certain of
our and our licensors' research has been or is being funded in part by
government grants. In connection with certain grants, the U.S. government
retains rights in the technology developed with the grant. These rights could
restrict our ability to fully capitalize upon the value of this
research.





Risks
Related to International Regulation





We may not be able to obtain required
approvals in other countries. The requirements governing the
conduct of clinical trials and cell culturing and marketing of our product
candidates outside the United States vary widely from country to country.
Foreign approvals may take longer to obtain than FDA approvals and can require,
among other things, additional testing and different clinical trial designs.
Foreign regulatory approval processes generally include all of the risks
associated with the FDA approval processes. Some foreign regulatory agencies
also must approve prices of the products. Regulatory approval in one country
does not ensure regulatory approval in another, but a failure or delay in
obtaining regulatory approval in one country may negatively impact the
regulatory process in others. We may not be able to file for regulatory
approvals and may not receive necessary approvals to market our product
candidates in any foreign country. If we fail to comply with these regulatory
requirements or fail to obtain and maintain required approvals in any foreign
country, we will not be able to sell our product candidates in that country and
our ability to generate revenue will be adversely affected.





Financial
Risks





We may not be able to raise the
required capital to conduct our operations and develop and commercialize our
products.   We require substantial additional capital resources
in order to conduct our operations and develop and commercialize our products
and run our facilities. We will need significant additional funds or a
collaborative partner, or both, to finance the research and development
activities of our therapies and potential products. Accordingly, we are
continuing to pursue additional sources of financing.  Our future
capital requirements will depend upon many factors, including:


-
              The continued progress and cost
      of our research and development
programs,
 -
              The proress with pre-clinical
      studies and clinical trials,
  49
 -
              The time and costs involved in
      obtaining regulatory
clearance,
 -
              The costs in preparing, filing,
      prosecuting, maintaining and enforcing patent
    claims,
 -
              The costs of developing sales,
      marketing and distribution channels and our ability to sell the
      therapies/products if
developed,
 -
              The costs involved in
      establishing manufacturing capabilities for commercial quantities of our
      proposed products,
 -
              Competing technological and
      market developments,
 -
              Market acceptance of our proposed
      products,
 -
              The costs for recruiting and
      retaining employees and consultants,
and
 -
              The costs for educating and
      training physicians about our proposed
      therapies/products.





Additional
financing through strategic collaborations, public or private equity financings
or other financing sources may not be available on acceptable terms, or at all.
Additional equity financing could result in significant dilution to our
shareholders. Further, if additional funds are obtained through arrangements
with collaborative partners, these arrangements may require us to relinquish
rights to some of our technologies, product candidates or products that we would
otherwise seek to develop and commercialize on our own. If sufficient capital is
not available, we may be required to delay, reduce the scope of or eliminate one
or more of our programs or potential products, any of which could have a
material adverse affect on our financial condition or business
prospects.





Risks
Relating to the Amended and Restated September 2005, September 2006, August 2007
and April 2008 Financings





If we are required for any reason to
repay our outstanding debentures we would be required to deplete our working
capital, if available, or raise additional funds. Our failure to repay the
convertible debentures, if required, could result in legal action against us,
which could require the sale of substantial assets. We
have outstanding, as of September 30, 2009, $17,309,453 aggregate original
principal amount of convertible debentures with $5,781,661 in 2008 Debentures
$8,863,489 in 2007 Debentures, $2,532,902 in 2006 Debentures, and $131,401 in
2005 Debentures. We are required to redeem on a monthly basis, by payment, at
our option, with cash or with shares of our common stock, 1/16th of the
aggregate original principal amount of the debentures.





Any event
of default could require the early repayment of the convertible debentures, and
additional interest is accruing on the outstanding principal balance of the
debentures. We anticipate that the full amount of the convertible debentures
will be converted into shares of our common stock, in accordance with the terms
of the convertible debentures; however no assurance can be provided that any
amount of debentures will be converted. If, prior to the maturity date, we are
required to repay the convertible debentures in full, we would be required to
use our limited working capital and raise additional funds. If we remain unable
to repay the notes when required, the debenture holders could commence legal
action against us to recover the amounts due. Any such action could require us
to curtail or cease operations.





On July
29, 2009, we entered into a consent, amendment and exchange agreement with
holders of our outstanding convertible debentures and warrants, which were
issued in private placements in 2005, 2006, 2007 and 2008. We agreed to issue to
each debenture holder in exchange for the holder’s debenture an amended and
restated debenture in a principal amount equal to the principal amount of the
holder’s debenture times 1.35 minus any interest paid thereon. The conversion
price under the amended and restated debentures was reduced to $0.10, subject to
certain customary anti-dilution adjustments. The maturity date under the amended
and restated debentures was extended until December 30, 2010. The amended and
restated debentures bear interest at 12% per annum. Further, we agreed to issue
to each holder in exchange for the holder’s warrant an amended and restated
warrant, which exercise price was reduced to $0.10, subject to certain customary
anti-dilution adjustments. Further, we agreed to issue to each holder in
exchange for the holder’s warrants amended and restated warrants, as well as
additional warrants exercisable into 79,076,873 shares of our common stock for a
total of warrants exercisable into 192,172,519 shares of common stock, both
warrants containing a reduced exercise price of $0.10, subject to certain
customary anti-dilution adjustments. The termination date under the amended and
restated warrants was extended until June 30, 2014. Simultaneously with the
signing of this agreement, we and the debenture holders entered into a
standstill and forbearance agreement, whereby the debenture holders agreed to
forbear from exercising their rights and remedies under the original debentures
and transaction documents.





There are a large number of shares
underlying our convertible debentures and convertible promissory notes in full,
and warrants that and the Company is liable to provide. The sale of these shares
may depress the market price of our common stock. As of September 30,
2009, on an aggregated basis our 2005, 2006, 2007 and 2008 debenture and
promissory note financings may result in being converted into 183,514,607 shares
of our common stock, and warrants, options and preferred stock that may be
converted into approximately 222,962,000 shares of our common
stock.





Sales of
a substantial number of shares of our common stock in the public market could
adversely affect the market price for our common stock and make it more
difficult for you to sell shares of our common stock at times and prices that
you feel are appropriate.


50


The issuance of shares upon
conversion of the convertible debentures and exercise of outstanding warrants
will cause immediate and substantial dilution to our existing
stockholders. The issuance of shares upon conversion of the convertible
debentures and exercise of warrants, including the replacement warrants, will
result in substantial dilution to the interests of other stockholders since the
selling security holders may ultimately convert and sell the full amount
issuable on conversion. Although no single selling security holder may convert
its convertible debentures and/or exercise its warrants if such conversion or
exercise would cause it to own more than 4.99% of our outstanding common stock,
this restriction does not prevent each selling security holder from converting
and/or exercising some of its holdings and then converting the rest of its
holdings. In this way, each selling security holder could sell more than this
limit while never holding more than this limit. There is no upper limit on the
number of shares that may be issued which will have the effect of further
diluting the proportionate equity interest and voting power of holders of our
common stock. In addition, the issuance of the 2008 Debentures and the 2008
Warrants triggered certain anti-dilution rights for certain third parties
currently holding our securities resulting in substantial dilution to the
interests of other stockholders.





Our
outstanding indebtedness on our 2005, 2006, 2007 and 2008 Debentures imposes
certain restrictions on how we conduct our business. In addition, all of our
assets, including our intellectual property, are pledged to secure this
indebtedness. If we fail to meet our obligations under the Debentures, our
payment obligations may be accelerated and the collateral securing the debt may
be sold to satisfy these obligations.





The
Debentures and related agreements contain various provisions that restrict our
operating flexibility. Pursuant to the agreement, we may not, among other
things:


-
                Except for certain permitted
      indebtedness, enter into, create, incur, assume, guarantee or suffer to
      exist any indebtedness for borrowed money of any kind, including but not
      limited to, a guarantee, on or with respect to any of its property or
      assets now owned or hereafter acquired or any interest therein or any
      income or profits therefrom,
 -
                Except for certain permitted
      liens, enter into, create, incur, assume or suffer to exist any liens of
      any kind, on or with respect to any of its property or assets now owned or
      hereafter acquired or any interest therein or any income or profits
      therefrom,
 -
                Amend our certificate of
      incorporation, bylaws or other charter documents so as to materially and
      adversely affect any rights of holders of the Debentures and
      Warrants,
 -
                Repay, repurchase or offer to
      repay, repurchase or otherwise acquire more than a de minimis number of
      shares of our common stock or common stock
    equivalents,
 -
                Enter into any transaction with
      any of our affiliates, which would be required to be disclosed in any
      public filing with the Securities and Exchange Commission, unless such
      transaction is made on an arm's-length basis and expressly approved by a
      majority of our disinterested directors (even if less than a quorum
      otherwise required for board
approval),
 -
                Pay cash dividends or
      distributions on any of our equity
  securities,
 -
                Grant certain registration
      rights,
 -
                Enter into any agreement with
      respect to any of the foregoing,
or
 -
                Make cash expenditures in excess
      of $1,000,000 per calendar month, subject to certain specified
      exceptions.




These
provisions could have important consequences for us, including (i) making it
more difficult for us to obtain additional debt financing from another lender,
or obtain new debt financing on terms favorable to us, (ii) causing us to use a
portion of our available cash for debt repayment and service rather than other
perceived needs and/or (iii) impacting our ability to take advantage of
significant, perceived business opportunities.





Our obligations under the Securities
Purchase Agreement are secured by substantially all of our assets. Our
obligations under certain security agreements, executed in connection with both
the 2007 Financing and 2008 Financings, with the holders of the debentures and
warrants are secured by substantially all of our assets. As a result, if we
default under the terms of the security agreement, such holders could foreclose
on their security interest and liquidate all of our assets. This would cause
operations to cease.





Risks
Related to Third Party Reliance





We depend on third parties to assist
us in the conduct of our preclinical studies and clinical trials, and any
failure of those parties to fulfill their obligations could result in costs and
delays and prevent us from obtaining regulatory approval or successfully
commercializing our product candidates on a timely basis, if at all. We
engage consultants and contract research organizations to help design, and to
assist us in conducting, our preclinical studies and clinical trials and to
collect and analyze data from those studies and trials. The consultants and
contract research organizations we engage interact with clinical investigators
to enroll patients in our clinical trials. As a result, we depend on these
consultants and contract research organizations to perform the studies and
trials in accordance with the investigational plan and protocol for each product
candidate and in compliance with regulations and standards, commonly referred to
as "good clinical practice", for conducting, recording and reporting results of
clinical trials to assure that the data and results are credible and accurate
and the trial participants are adequately protected, as required by the FDA and
foreign regulatory agencies. We may face delays in our regulatory approval
process if these parties do not perform their obligations in a timely or
competent fashion or if we are forced to change service providers.





We depend on our collaborators to
help us develop and test our proposed products, and our ability to develop and
commercialize products may be impaired or delayed if collaborations are
unsuccessful. Our strategy for the development, clinical testing and
commercialization of our proposed products requires that we enter into
collaborations with corporate partners, licensors, licensees and others. We are
dependent upon the subsequent success of these other parties in performing their
respective responsibilities and the continued cooperation of our partners. Under
agreements with collaborators, we may rely significantly on such collaborators
to, among other things:




-
              Design and conduct advanced
      clinical trials in the event that we reach clinical
      trials;
  51
  -
              Fund research and development
      activities with us;
 -
              Pay us fees upon the achievement
      of milestones; and
 -
              market with us any commercial
      products that result from our
  collaborations.





Our
collaborators may not cooperate with us or perform their obligations under our
agreements with them. We cannot control the amount and timing of our
collaborators’ resources that will be devoted to our research and development
activities related to our collaborative agreements with them. Our collaborators
may choose to pursue existing or alternative technologies in preference to those
being developed in collaboration with us.





The development and commercialization
of potential products will be delayed if collaborators fail to conduct these
activities in a timely manner, or at all. In addition, our collaborators could
terminate their agreements with us and we may not receive any development or
milestone payments. If we do not achieve milestones set forth in the
agreements, or if our collaborators breach or terminate their collaborative
agreements with us, our business may be materially harmed.





We are in the Early Stages of a
Strategic Joint Venture which may slow, impede or result in the termination of
potential therapeutic products whose development is now the responsibility of
the partnership and not solely of the Company.  T he Company
has entered into a new partnership (CHA) and as a result, we are subject to 3
rd
party interests and control issues, not the least of which relates to certain of
our employees no longer being exclusively managed by us. We therefore could be
at risk for losing key employees. Additionally substantial operating and working
capital will be required and there is no assurance that CHA Biotech Co. limited,
partner in our joint venture, will be able to fund their requirements. Any
failure on their part could negatively impact our product development, human
capital and financial resources allocated to other of our programs.





In an effort to conserve financial
resources (see FINANCIAL RISK), we have implemented reductions in our work
force. As a result of these and other factors, we may not be successful
in hiring or retaining key personnel. Our inability to replace any key employee
could harm our operations.





Our reliance on the activities of our
non-employee consultants, research institutions, and scientific contractors,
whose activities are not wholly within our control, may lead to delays in
development of our proposed products. We rely extensively upon and have
relationships with scientific consultants at academic and other institutions,
some of whom conduct research at our request, and other consultants with
expertise in clinical development strategy or other matters. These consultants
are not our employees and may have commitments to, or consulting or advisory
contracts with, other entities that may limit their availability to us. We have
limited control over the activities of these consultants and, except as
otherwise required by our collaboration and consulting agreements to the extent
they exist, can expect only limited amounts of their time to be dedicated to our
activities. These research facilities may have commitments to other commercial
and non-commercial entities. We have limited control over the operations of
these laboratories and can expect only limited amounts of time to be dedicated
to our research goals.





Preclinical
& Clinical Product Development Risks





Limited experience in conducting and
managing preclinical development activities, clinical trials and the application
process necessary to obtain regulatory approvals. Our limited experience
in conducting and managing preclinical development activities, clinical trials
and the application process necessary to obtain regulatory approvals might
prevent us from successfully designing or implementing a preclinical study or
clinical trial. If we do not succeed in conducting and managing our preclinical
development activities or clinical trials, or in obtaining regulatory approvals,
we might not be able to commercialize our product candidates, or might be
significantly delayed in doing so, which will materially harm our
business.





Our
ability to generate revenues from any of our product candidates will depend on a
number of factors, including our ability to successfully complete clinical
trials, obtain necessary regulatory approvals and implement our
commercialization strategy. In addition, even if we are successful in obtaining
necessary regulatory approvals and bringing one or more product candidates to
market, we will be subject to the risk that the marketplace will not accept
those products. We may, and anticipate that we will need to, transition from a
company with a research and development focus to a company capable of supporting
commercial activities and we may not succeed in such a transition.




Because of the numerous risks and
uncertainties associated with our product development and commercialization
efforts, we are unable to predict the extent of our future losses or when or if
we will become profitable. Our failure to successfully commercialize our
product candidates or to become and remain profitable could depress the market
price of our common stock and impair our ability to raise capital, expand our
business, diversify our product offerings and continue our
operations.


52


None of the products that we are
currently developing has been approved by the FDA or any similar regulatory
authority in any foreign country. Our approach of using cell-based therapy for
the treatment of Retinal disease (we are beginning with a treatment for
Startgardt’s disease and Age-related Macular Degeneration) is risky and unproven
and no products using this approach have received regulatory approval in the
United States or Europe. We believe that no company has yet been
successful in its efforts to obtain regulatory approval in the United States or
Europe of a cell-based therapy product for the treatment of retinal disease or
degeneration in humans. Cell-based therapy products, in general, may be
susceptible to various risks, including undesirable and unintended side effects,
unintended immune system responses, inadequate therapeutic efficacy or other
characteristics that may prevent or limit their approval by regulators or
commercial use. Many companies in the industry have suffered significant
setbacks in advanced clinical trials, despite promising results in earlier
trials. If our clinical trials are unsuccessful or significantly delayed, or if
we do not complete our clinical trials, we will not receive regulatory approval
for or be able to commercialize our product candidates.





Our lead product candidate, our
therapeutic Retinal program has note yet started Phase I Clinical Trials and has
not yet received approval from the FDA or any similar foreign regulatory
authority for any indication. We cannot market any product candidate
until regulatory agencies grant approval or licensure. In order to obtain
regulatory approval for the sale of any product candidate, we must, among other
requirements, provide the FDA and similar foreign regulatory authorities with
preclinical and clinical data that demonstrate to the satisfaction of regulatory
authorities that our product candidates are safe and effective for each
indication under the applicable standards relating to such product candidate.
The preclinical studies and clinical trials of any product candidates must
comply with the regulations of the FDA and other governmental authorities in the
United States and similar agencies in other countries. Our therapeutic Retinal
program may never receive approval from the FDA or any similar foreign
regulatory authority.




We
may experience numerous unforeseen events during, or as a result of, the
clinical trial process that could delay or prevent regulatory approval and/or
commercialization of our product candidates, including the
following:




-
              The FDA or similar foreign
      regulatory authorities may find that our product candidates are not
      sufficiently safe or effective or may find our cell culturing processes or
      facilities unsatisfactory,
 -
              Officials at the FDA or similar
      foreign regulatory authorities may interpret data from preclinical studies
      and clinical trials differently than we
  do,
 -
              Our clinical trials may produce
      negative or inconclusive results or may not meet the level of statistical
      significance required by the FDA or other regulatory authorities, and we
      may decide, or regulators may require us, to conduct additional
      preclinical studies and/or clinical trials or to abandon one or more of
      our development programs,
 -
              The FDA or similar foreign
      regulatory authorities may change their approval policies or adopt new
      regulations,
 -
              There may be delays or failure in
      obtaining approval of our clinical trial protocols from the FDA or other
      regulatory authorities or obtaining institutional review board approvals
      or government approvals to conduct clinical trials at prospective
      sites,
 -
              We, or regulators, may suspend or
      terminate our clinical trials because the participating patients are being
      exposed to unacceptable health risks or undesirable side
      effects,
 -
              We may experience difficulties in
      managing multiple clinical
sites,
 -
              Enrollment in our clinical trials
      for our product candidates may occur more slowly than we anticipate, or we
      may experience high drop-out rates of subjects in our clinical trials,
      resulting in significant
delays,
 -
              We may be unable to manufacture
      or obtain from third party manufacturers sufficient quantities of our
      product candidates for use in clinical trials,
  and
 -
              Our product candidates may be
      deemed unsafe or ineffective, or may be perceived as being unsafe or
      ineffective, by healthcare providers for a particular
      indication.





Any delay
of regulatory approval will harm our business.





Risks
Related to Competition





The market for therapeutic stem cell
products is highly competitive. We expect that our most significant
competitors will be fully integrated pharmaceutical companies and more
established biotechnology companies. These companies are developing stem
cell-based products and they have significantly greater capital resources in
research and development, manufacturing, testing, obtaining regulatory
approvals, and marketing capabilities. Many of these potential competitors are
further along in the process of product development and also operate large,
company-funded research and development programs. As a result, our competitors
may develop more competitive or affordable products, or achieve earlier patent
recognition and filings.





The biotechnology industries are
characterized by rapidly evolving technology and intense competition. Our
competitors include major multinational pharmaceutical companies, specialty
biotechnology companies and chemical and medical products companies operating in
the fields of regenerative medicine, cell therapy, tissue engineering and tissue
regeneration. Many of these companies are well-established and possess
technical, research and development, financial and sales and marketing resources
significantly greater than ours. In addition, certain smaller biotech companies
have formed strategic collaborations, partnerships and other types of joint
ventures with larger, well established industry competitors that afford these
companies' potential research and development and commercialization advantages.
Academic institutions, governmental agencies and other public and private
research organizations are also conducting and financing research activities
which may produce products directly competitive to those we are developing.
Moreover, many of these competitors may be able to obtain patent protection,
obtain FDA and other regulatory approvals and begin commercial sales of their
products before we do.


53





In the general area of cell-based
therapies (including both ES cell and autologous cell therapies), we compete
with a variety of companies, most of whom are specialty biotechnology companies,
such as Geron Corporation, Genzyme Corporation, StemCells, Inc., Aastrom
Biosciences, Inc., Viacell, Inc., MG Biotherapeutics, Celgene, BioHeart, Inc.,
Baxter Healthcare, Osiris Therapeutics and Cytori. Each of these
companies are well-established and have substantial technical and financial
resources compared to us. However, as cell-based products are only just emerging
as medical therapies, many of our direct competitors are smaller biotechnology
and specialty medical products companies. These smaller companies may become
significant competitors through rapid evolution of new technologies. Any of
these companies could substantially strengthen their competitive position
through strategic alliances or collaborative arrangements with large
pharmaceutical or biotechnology companies.





The diseases and medical conditions
we are targeting have no effective long-term therapies. Nevertheless, we expect
that our technologies and products will compete with a variety of therapeutic
products and procedures offered by major pharmaceutical companies (in the
Retinal Disease indication one of our primary competitors is Celgene). Many
pharmaceutical and biotechnology companies are investigating new drugs and
therapeutic approaches for the same purposes, which may achieve new efficacy
profiles, extend the therapeutic window for such products, alter the prognosis
of these diseases, or prevent their onset. We believe that our products,
when and if successfully developed, will compete with these products principally
on the basis of improved and extended efficacy and safety and their overall
economic benefit to the health care system.





Competition
for any stem cell products that we may develop may be in the form of existing
and new drugs, other forms of cell transplantation, ablative and simulative
procedures, and gene therapy. We believe that some of our competitors are also
trying to develop stem and progenitor cell-based technologies. We expect that
all of these products will compete with our potential stem cell products based
on efficacy, safety, cost and intellectual property positions. We may also face
competition from companies that have filed patent applications relating to the
use of genetically modified cells to treat disease, disorder or injury. In the
event our therapies should require the use of such genetically modified cells,
we may be required to seek licenses from these competitors in order to
commercialize certain of our proposed products, and such licenses may not be
granted.





If
we develop products that receive regulatory approval, they would then have to
compete for market acceptance and market share. For certain of our potential
products, an important success factor will be the timing of market introduction
of competitive products. This timing will be a function of the relative speed
with which we and our competitors can develop products, complete the clinical
testing and approval processes, and supply commercial quantities of a product to
market. These competitive products may also impact the timing of clinical
testing and approval processes by limiting the number of clinical investigators
and patients available to test our potential products.




Our competition includes both public
and private organizations and collaborations among academic institutions and
large pharmaceutical companies, most of which have significantly greater
experience and financial resources than we do. Private and public
academic and research institutions also compete with us in the research and
development of therapeutic products based on human embryonic and adult stem cell
technologies. In the past several years, the pharmaceutical industry has
selectively entered into collaborations with both public and private
organizations to explore the possibilities that stem cell therapies may present
for substantive breakthroughs in the fight against disease.




The biotechnology and pharmaceutical
industries are characterized by intense competition. We compete against numerous
companies, both domestic and foreign, many of which have substantially greater
experience and financial and other resources than we have. Several such
enterprises have initiated cell therapy research programs and/or efforts to
treat the same diseases targeted by us. Companies such as Geron
Corporation, Genzyme Corporation, StemCells, Inc., Aastrom
Biosciences, Inc. and Viacell, Inc., as well as others, many of which
have substantially greater resources and experience in our fields than we do,
are well situated to effectively compete with us. Any of the world's largest
pharmaceutical companies represents a significant actual or potential competitor
with vastly greater resources than ours. These companies hold licenses to
genetic selection technologies and other technologies that are competitive with
our technologies. These and other competitive enterprises have devoted, and will
continue to devote, substantial resources to the development of technologies and
products in competition with us.




In addition, many of our competitors
have significantly greater experience than we have in the development,
pre-clinical testing and human clinical trials of biotechnology and
pharmaceutical products, in obtaining FDA and other regulatory approvals of such
products and in manufacturing and marketing such products. Accordingly
our competitors may succeed in obtaining FDA approval for products more rapidly
or effectively than we can. Our competitors may also be the first to discover
and obtain a valid patent to a particular stem cell technology which may
effectively block all others from doing so. It will be important for us or our
collaborators to be the first to discover any stem cell technology that we are
seeking to discover. Failure to be the first could prevent us from
commercializing all of our research and development affected by that discovery.
Additionally, if we commence commercial sales of any products, we will also be
competing with respect to manufacturing efficiency and sales and marketing
capabilities, areas in which we have no experience.




54




General
Risks Relating to Our Business


We are subject to litigation that
will be costly to defend or pursue and uncertain in its outcome. Our
business may bring us into conflict with our licensees, licensors, or others
with whom we have contractual or other business relationships, or with our
competitors or others whose interests differ from ours. If we are unable to
resolve those conflicts on terms that are satisfactory to all parties, we may
become involved in litigation brought by or against us. That litigation is
likely to be expensive and may require a significant amount of management's time
and attention, at the expense of other aspects of our business. The outcome of
litigation is always uncertain, and in some cases could include judgments
against us that require us to pay damages, enjoin us from certain activities, or
otherwise affect our legal or contractual rights, which could have a significant
adverse effect on our business. See "LEGAL PROCEEDINGS" set forth in
Part I, Item 3 of this Quarterly Report on Form 10-Q for a more
complete discussion of currently pending litigation against the
Company.




We may not be able to obtain
third-party patient reimbursement or favorable product pricing, which would
reduce our ability to operate profitably. Our ability to successfully
commercialize certain of our proposed products in the human therapeutic field
may depend to a significant degree on patient reimbursement of the costs of such
products and related treatments at acceptable levels from government
authorities, private health insurers and other organizations, such as health
maintenance organizations. We cannot assure you that reimbursement in the United
States or foreign countries will be available for any products we may develop
or, if available, will not be decreased in the future, or that reimbursement
amounts will not reduce the demand for, or the price of, our products with a
consequent harm to our business. We cannot predict what additional regulation or
legislation relating to the health care industry or third-party coverage and
reimbursement may be enacted in the future or what effect such regulation or
legislation may have on our business. If additional regulations are overly
onerous or expensive, or if health care related legislation makes our business
more expensive or burdensome than originally anticipated, we may be forced to
significantly downsize our business plans or completely abandon our business
model.




Our products are likely to be
expensive to manufacture, and they may not be profitable if we are unable to
control the costs to manufacture them. Our products are likely to be
significantly more expensive to manufacture than most other drugs currently on
the market today. Our present manufacturing processes produce modest quantities
of product intended for use in our ongoing research activities, and we have not
developed processes, procedures and capability to produce commercial volumes of
product. We hope to substantially reduce manufacturing costs through process
improvements, development of new science, increases in manufacturing scale and
outsourcing to experienced manufacturers. If we are not able to make these or
other improvements, and depending on the pricing of the product, our profit
margins may be significantly less than that of most drugs on the market today.
In addition, we may not be able to charge a high enough price for any cell
therapy product we develop, even if they are safe and effective, to make a
profit. If we are unable to realize significant profits from our potential
product candidates, our business would be materially harmed.




Our current source of revenues
depends on the stability and performance of our sub-licensees. Our
ability to collect royalties on product sales from our sub-licensees will depend
on the financial and operational success of the companies operating under a
sublicense. Revenues from those licensees will depend upon the financial and
operational success of those third parties. We cannot assure you that these
licensees will be successful in obtaining requisite financing or in developing
and successfully marketing their products. These licensees may experience
unanticipated obstacles including regulatory hurdles, and scientific or
technical challenges, which could have the effect of reducing their ability to
generate revenues and pay us royalties.




We depend on key personnel for our
continued operations and future success, and a loss of certain key personnel
could significantly hinder our ability to move forward with our business
plan. Because of the specialized nature of our business, we are highly
dependent on our ability to identify, hire, train and retain highly qualified
scientific and technical personnel for the research and development activities
we conduct or sponsor. The loss of one or more certain key executive officers,
or scientific officers, would be significantly detrimental to us. In addition,
recruiting and retaining qualified scientific personnel to perform research and
development work is critical to our success. Our anticipated growth and
expansion into areas and activities requiring additional expertise, such as
clinical testing, regulatory compliance, manufacturing and marketing, will
require the addition of new management personnel and the development of
additional expertise by existing management personnel. There is intense
competition for qualified personnel in the areas of our present and planned
activities, and there can be no assurance that we will be able to continue to
attract and retain the qualified personnel necessary for the development of our
business. The failure to attract and retain such personnel or to develop such
expertise would adversely affect our business.




Our credibility as a business
operating in the field of human embryonic stem cells is largely dependent upon
the support of our Ethics Advisory Board. Because the use of human
embryonic stem cells gives rise to ethical, legal and social issues, we have
instituted an Ethics Advisory Board. Our Ethics Advisory Board is made up of
highly qualified individuals with expertise in the field of human embryonic stem
cells. We cannot assure you that these members will continue to serve on our
Ethics Advisory Board, and the loss of any such member may affect the
credibility and effectiveness of the Board. As a result, our business may be
materially harmed in the event of any such loss.




Our insurance policies may be
inadequate and potentially expose us to unrecoverable risks. We have
limited director and officer insurance and commercial insurance policies. Any
significant insurance claims would have a material adverse effect on our
business, financial condition and results of operations. Insurance availability,
coverage terms and pricing continue to vary with market conditions. We endeavor
to obtain appropriate insurance coverage for insurable risks that we identify,
however, we may fail to correctly anticipate or quantify insurable risks, we may
not be able to obtain appropriate insurance coverage, and insurers may not
respond as we intend to cover insurable events that may occur. We have observed
rapidly changing conditions in the insurance markets relating to nearly all
areas of traditional corporate insurance. Such conditions have resulted in
higher premium costs, higher policy deductibles, and lower coverage limits. For
some risks, we may not have or maintain insurance coverage because of cost or
availability.


55





We have no product liability
insurance, which may leave us vulnerable to future claims we will be unable to
satisfy. The testing, manufacturing, marketing and sale of human
therapeutic products entail an inherent risk of product liability claims, and we
cannot assure you that substantial product liability claims will not be asserted
against us. We have no product liability insurance. In the event we are forced
to expend significant funds on defending product liability actions, and in the
event those funds come from operating capital, we will be required to reduce our
business activities, which could lead to significant losses.




We
cannot assure you that adequate insurance coverage will be available in the
future on acceptable terms, if at all, or that, if available, we will be able to
maintain any such insurance at sufficient levels of coverage or that any such
insurance will provide adequate protection against potential liabilities.
Whether or not a product liability insurance policy is obtained or maintained in
the future, any product liability claim could harm our business or financial
condition.




We presently have members of
management and other key employees located in various locations throughout the
country which adds complexities to the operation of the business.
Presently, we have members of management and other key employees located in both
California and Massachusetts, which adds complexities to the operation of our
business.




We face risks related to compliance
with corporate governance laws and financial reporting standards. The
Sarbanes-Oxley Act of 2002, as well as related new rules and regulations
implemented by the Securities and Exchange Commission and the Public Company
Accounting Oversight Board, require changes in the corporate governance
practices and financial reporting standards for public companies. These new
laws, rules and regulations, including compliance with Section 404 of the
Sarbanes-Oxley Act of 2002 relating to internal control over financial
reporting, referred to as Section 404, have materially increased our legal
and financial compliance costs and made some activities more time-consuming and
more burdensome.





Risks
Relating to Our Common Stock




Stock prices for biotechnology
companies have historically tended to be very volatile.
    Stock prices and trading volumes for many biotechnology
companies fluctuate widely for a number of reasons, including but not limited to
the following factors, some of which may be unrelated to their businesses or
results of operations:




-
              Clinical trial
      results,
 -
              The amount of cash resources and
      ability to obtain additional
funding,
 -
              Announcements of research
      activities, business developments, technological innovations or new
      products by companies or their
  competitors,
 -
              Entering into or terminating
      strategic relationships,
 -
              Changes in government
      regulation,
 -
              Disputes concerning patents or
      proprietary rights,
 -
              Changes in revenues or expense
      levels,
 -
              Public concern regarding the
      safety, efficacy or other aspects of the products or methodologies being
      developed,
 -
              Reports by securities
      analysts,
 -
              Activities of various interest
      groups or organizations,
 -
              Media coverage,
      and
 -
              Status of the investment
      markets.




This
market volatility, as well as general domestic or international economic, market
and political conditions, could materially and adversely affect the market price
of our common stock and the return on your investment.




A significant number of shares of our
common stock have become available for sale and their sale could depress the
price of our common stock. On March 1, 2008, a significant number of
our outstanding securities (including the 2007 Debentures and the 2007 Warrants
and the shares of common stock underlying such securities) that were previously
restricted became eligible for sale under Rule 144 of the Securities Act,
and their sale will not be subject to any volume limitations.




Not
including the shares of common stock underlying the 2005 Debentures, the 2005
Warrants, the 2006 Debentures, the 2006 Warrants, the replacement warrants, the
2007 Debentures, the 2007 Warrants, the February Promissory Note, the April 2008
Debentures, the February and April 2008 Warrants, and the Series A-1 convertible
preferred stock, there are presently approximately 27,739,000 outstanding
options, warrants and other securities convertible or exercisable into shares of
our common stock.




We may
also sell a substantial number of additional shares of our common stock in
connection with a private placement or public offering of shares of our common
stock (or other series or class of capital stock to be designated in the
future). The terms of any such private placement would likely require us to
register the resale of any shares of capital stock issued or issuable in the
transaction. We have also issued common stock to certain parties, such as
vendors and service providers, as payment for products and services. Under these
arrangements, we may agree to register the shares for resale soon after their
issuance. We may also continue to pay for certain goods and services with
equity, which would dilute your interest in the company.


56




Sales of
a substantial number of shares of our common stock under any of the
circumstances described above could adversely affect the market price for our
common stock and make it more difficult for you to sell shares of our common
stock at times and prices that you feel are appropriate.




We do not intend to pay cash
dividends on our common stock in the foreseeable future. Any payment of
cash dividends will depend upon our financial condition, results of operations,
capital requirements and other factors and will be at the discretion of our
board of directors. We do not anticipate paying cash dividends on our common
stock in the foreseeable future. Furthermore, we may incur additional
indebtedness that may severely restrict or prohibit the payment of
dividends.




Our common stock is subject to "penny
stock" regulations and restrictions on initial and secondary broker-dealer
sales. The Securities and Exchange Commission has adopted regulations
which generally define "penny stock" to be any listed, trading equity security
that has a market price less than $5.00 per share or an exercise price of less
than $5.00 per share, subject to certain exemptions. Penny stocks are subject to
certain additional oversight and regulatory requirements. Brokers and dealers
affecting transactions in our common stock in many circumstances must obtain the
written consent of a customer prior to purchasing our common stock, must obtain
information from the customer and must provide disclosures to the customer.
These requirements may restrict the ability of broker-dealers to sell our common
stock and may affect your ability to sell your shares of our common stock in the
secondary market.




We have not timely filed our
financial statements in accordance with SEC rules and regulations. We did
not file our June 30, 2008 Form 10Q, September 30, 2008 Form 10Q, December 31,
2008 Form 10K, or March 31, 2009 Form 10Q timely in accordance with
timelines required by the SEC.







ITEM
3. QUANTITATIVE AND QUALITATIVE DISCLOSURES ABOUT MARKET RISK




Not
applicable.


57




ITEM
4. CONTROLS AND PROCEDURES





Disclosure
Controls and Procedures




We
maintain disclosure controls and procedures designed to ensure that information
required to be disclosed in the reports we file pursuant to the Exchange Act are
recorded, processed, summarized and reported within the time periods specified
in the rules and forms of the Securities and Exchange Commission, and that
such information is accumulated and communicated to our Chief Executive Officer
(“CEO”), who also serves as the Company’s Principal Financial Officer (“PFO”),
to allow timely decisions regarding required disclosure. In designing and
evaluating the disclosure controls and procedures, management recognized that
any controls and procedures, no matter how well designed and operated, can only
provide a reasonable assurance of achieving the desired control objectives, and
in reaching a reasonable level of assurance, management necessarily was required
to apply its judgment in evaluating the cost-benefit relationship of possible
controls and procedures. Management designed the disclosure controls and
procedures to provide reasonable assurance of achieving the desired control
objectives.




We
carried out an evaluation, under the supervision and with the participation of
our management, including our CEO and PFO, of the effectiveness of the design
and operation of our disclosure controls and procedures as of the end of the
period covered by this Quarterly Report.  We have determined that the loss
of certain personnel in our legal, accounting and finance departments, when
considered collectively in light of the number and complexity of accounting
matters requiring consideration, created a possibility that a material
misstatement of our financial statements could occur and may not be prevented or
detected.  In addition, we have identified material weaknesses in internal
control over financial reporting as discussed in our most recent annual report
filed on Form 10-K.  As a result, our disclosure controls and
procedures were not effective as of September 30, 2009.  To address these
material weaknesses, we have retained an outside accounting consulting firm to
assist the Company in preparing and reviewing the consolidated financial
statements and preparing this Quarterly Report on Form 10-Q.





Nothwithstanding
any material weaknesses identified above, we believe our financial statements
fairly present in all material respects the financial position, results of
operations and cash flows for the interim periods presented in our quarterly
report on Form 10-Q.




Changes
in Internal Control over Financial Reporting




There
have been no other significant changes in our internal controls over financial
reporting (as such term is defined in Rule 13a-15(f) and
15d-15(f) under the Securities Exchange Act) during the quarter ended
September 30, 2009 that have materially affected, or are reasonably likely to
materially affect, our internal control over financial reporting.





PART II.
OTHER INFORMATION




ITEM
1. LEGAL PROCEEDINGS




Gary D. Aronson v. Advanced Cell
Technology, Inc., Superior Court of California, County of Alameda, Case No.
RG07348990. John S.
Gorton v. Advanced Cell Technology, Inc, Superior Court of California, County of
Alameda Case No. RG07350437.  On October 1, 2007 Gary D. Aronson
brought suit against us with respect to a dispute over the interpretation of the
anti-dilution provisions of our warrants issued to Mr. Aronson on or about
September 14, 2005. John S. Gorton initiated a similar suit on October 10,
2007.  The two cases have been consolidated. The plaintiffs allege that we
breached warrants to purchase securities issued by us to these individuals by
not timely issuing stock after the warrants were exercised, failing to issue
additional shares of stock in accordance with the terms of the warrants and
failing to provide proper notice of certain events allegedly triggering
Plaintiffs' purported rights to additional shares.  Plaintiffs
assert monetary damages in excess of $14 million.  Plaintiffs may
alternatively seek additional shares in the Company with a value potentially in
excess of $14 million, or may seek a combination of monetary damages and shares
in the Company.  Plaintiffs also seek prejudgment interest and
attorney fees.  Discovery is not complete and no conclusions have been
reached as to the potential exposure to us or whether we have liability.





Alexandria Real Estate-79/96
Charlestown Navy Yard v.
Advanced Cell Technology, Inc. and Mytogen, Inc. (Suffolk County,
Massachusetts) :  The Company and its subsidiary Mytogen, Inc. are
currently defending themselves against a civil action brought in Suffolk
Superior Court, No. 09-442-B, by their former landlord at 79/96 Thirteenth
Street, Charlestown, Massachusetts, a property vacated by us and Mytogen
effective May 31, 2008. In that action, Alexandria Real Estate-79/96 Charlestown
Navy Yard (“ARE”) is alleging that it has been unable to relet the premises and
therefore seeking rent for the vacated premises since September 2008. 
Alexandria is also seeking certain clean-up and storage expenses.  We are
defending against the suit, claiming that ARE had breached the covenant of quiet
enjoyment as of when Mytogen vacated, and that had ARE used reasonable diligence
in its efforts to secure a new tenant, it would have been more successful. 
No trial date has been set.





Bristol Investment Fund, Ltd. as
Collateral Agent for the Holders of Certain Original Issue Discount Senior
Convertible Debentures v. Alexandria Real Estate—79/96 Charlestown Navy Yard,
LLC (Suffolk Superior Court). The Company has been named as a third party
defendant in this action, filed September 16, 2009, in which the plaintiff
alleges that Alexandria Real Estate (“Alexandria”) improperly charged a trustee
holding approximately $146,000 of funds in a Company account that Bristol
claimed as collateral. Alexandria brought a third party complaint against the
Company for indemnification.


58




Bristol Investment Fund, Ltd. and
Bristol Capital, LLC v. Advanced Cell Technology, Inc. and Mytogen, Inc.
(Supreme Court of the State of New York, County of New York): On March 9,
2009, plaintiffs filed a complaint and summons in the Supreme Court of the State
of New York, County of New York against the Company and its subsidiary Mytogen,
Inc. Plaintiffs’ complaint alleges, among other things, that the Company has
breached the terms of certain contracts with plaintiffs; namely, convertible
debentures and a consulting agreement. Plaintiffs seek preliminary and permanent
injunctive relief directing the Company to deliver to plaintiff Bristol
Investment Fund, Ltd. (“Bristol”) 2.5 million shares of its common stock,
declaring a conversion price of $0.02 for the convertible debentures held by
plaintiffs, and directing the Company to honor plaintiff’s future conversion
requests. Plaintiffs also seek compensatory damages in an amount to be
determined at trial, but alleged in the complaint to exceed $1.5 million. On May
1, 2009, the Company filed an answer to plaintiffs’ complaint. On May 13, 2009,
the Company filed a motion to stay the action and to compel arbitration of all
claims by Bristol. The court has not yet ruled on the Company’s motion to stay
the action and to compel arbitration. On or about September 16, 2009, plaintiffs
filed an order to show cause, seeking the issuance of a preliminary injunction
directing the Company to deliver to Bristol 2.5 shares of its common stock
pursuant to a convertible debenture and 47.4 million shares of its common
stock  pursuant to common stock purchase warrants, declaring a
conversion price of $0.02 for the convertible debenture held by plaintiffs, and
enjoining or restraining the Company from issuing shares of its common stock to
any entity other than plaintiffs or the other holders of convertible debentures.
On September 25, 2009, the Company submitted its response in opposition to
plaintiffs’ motion and moved by cross-motion for dismissal of the complaint,
based on the terms of the consent, waiver, amendment and exchange agreement
entered into between the Company and the holders of over 95% of the outstanding
principal amount of the Amended and Restated Debentures. The court has not yet
ruled on the respective motions. The Company intends to continue to contest the
case vigorously.








ITEM
2. UNREGISTERED SALES OF EQUITY SECURITIES AND USE OF PROCEEDS




The
issuances of the equity securities described below were made in reliance upon
the exemption from registration under Section 4(2) of the Securities
Act of 1933, as amended, relating to sales by an issuer not involving a public
offering, and/or pursuant to the requirements of one or more of the safe harbors
provided in Regulation D under the Securities Act.





Effective
March 3, 2009, we entered into a $5 million credit facility (“Facility”) with a
life sciences fund. Under the terms of the agreement, we may draw down funds, as
needed, from the investor through the issuance of Series A-1 convertible
preferred stock, par value $.001, at a basis of 1 share of Series A-1
convertible preferred stock for every $10,000 invested. The preferred stock pays
dividends, in kind of preferred stock, at an annual rate of 10%, matures in four
years from the initial drawdown date, and is convertible at the option of the
holder into common stock at $0.75 per share. Upon the earlier of (i) the fourth
anniversary of the issuance date, and (ii) the occurrence of a major
transaction, each holder shall have the right, at such holder’s option, to
require the Company to redeem all or a portion of such holder’s share of Series
A-1 preferred stock, at a price per share equal to the Series A-1 liquidation
value. A major transaction includes (i) the consolidation, merger, or other
business combination of the Company with or into another entity, (ii) the sale
or transfer of more than 50% of the Company’s assets other than inventory in the
ordinary course of business in one or more related series of transactions, or
(iii) closing of a purchase, tender or exchange offer made  to the
holders of more than 50% of the outstanding shares of common stock in which more
than 50% of the outstanding shares of common stock were tendered and accepted.
The Company shall have the right, at the Company’s option, to redeem all or a
portion of the shares of Series A-1 preferred stock, at any time at a price per
share of Series A-1 preferred stock equal to 100% of the Series A-1 liquidation
value. In the event the closing price of the our common stock during the 5
trading days following the put notice falls below 75% of the average of the
closing bid price in the 5 trading days prior to the put closing date, the
investor may, at its option, and without penalty, decline to purchase the
applicable put shares on the put closing date. We may terminate the agreement
and our right to initiate future draw-downs by providing 30 days advanced
written notice to the investor. Upon any liquidation, dissolution or winding up
of the Company, whether voluntary or involuntary, after payment or provision for
payment of debts and other liabilities of the Corporation, before any
distribution or payment shall be made to the holders of any other equity
securities of the Company by reason of their ownership thereof, the holders of
the Series A-1 preferred stock shall first be entitled to be paid out of the
assets of the Company available for distribution to its stockholders an amount
with respect to each share of Series A-1 preferred stock equal to $10,000, plus
any accrued by unpaid dividends. If, upon dissolution or winding up of the
Company, the assets of the Company shall be insufficient to make payment in full
to all holders, then such assets shall be distributed among the holders at the
time outstanding, ratably in proportion to the full amounts to which they would
otherwise be respectively entitled.





Conditions
precedent to the Company’s right to deliver a put notice:





·
            The
      common stock shall be listed for and actively trading on a trading market,
      and to the Company’s knowledge there is no notice of any suspension or
      delisting with respect to the trading of the shares of common stock on
      such market or exchange;


·
            The
      representations and warranties of the Company set forth in the agreement
      are true and correct in all material respects as if made on such date, and
      no default shall have occurred under the agreement, or any other agreement
      with the investor, or investor affiliate, and the Company shall deliver an
      Officer’s Closing Certificate, signed by an officer of the Company, to
      such effect, to the investor;


·
            The
      Company has timely filed (or obtained extension in respect thereof and
      filed within the applicable grace period) all reports to be filed by the
      Company pursuant to the exchange
agreement;


·
            There
      have been no material changes in the Company’s business prospects or
      financial condition since the investment commitment closing, including but
      not limited to incurring material
liabilities;


59





·
            Except
      for the debenture agreements, the Company is not, and will not be as a
      result of the applicable put, in default of any material
      agreement;


·
            There
      is no current legal action against the Company whereby the transaction
      would be affected, of which the investor has not been made
      aware;


·
            Except
      with prior approval of the investor, the proceeds from the facility shall
      be used only for the purposes of advancement of the Company’s Retinal
      Pigment Epithelial (RPE) Program for the treatment of macular degeneration
      and other retinal degenerative
diseases;


·
            All
      DWAC shares are DTC eligible and can be immediately converted into
      electronic form without restrictions on resale;
  and


·
            The
      Company has a sufficient number of duly authorized shares of common stock
      for issuance in such amount as may be required to fulfill its obligations
      pursuant to its outstanding agreements with the investor or any investor
      affiliate.




On  October
19, 2009, we entered into two letter agreements with Volation Life Sciences
Capital Partners, LLC (“Volation”), pursuant to which (i) we reduced the
conversion price of our outstanding Series A-1 convertible preferred stock
issued to Volation to $.10 per share resulting in 22,880,000 shares of Common
Stock upon conversion, (ii) issued Volation 2,500,000 shares of its Common Stock
at $0.10 per share in payment of an outstanding commitment fee, and (iii)
Volation waived the delinquency in  non-payment of the $250,000
commitment fee required pursuant to the preferred stock purchase agreement
between the Company and Volation.





On July
29, 2009, we entered into a consent, amendment and exchange agreement (the
“Consent and Amendment”) with holders (the “Holders”) of the Company’s
outstanding convertible debentures in the aggregate outstanding principal amount
of $20,353,878 (the “Debentures”) and warrants to purchase an aggregate of
192,148,119 shares of the Company’s common stock (the “Warrants”), which were
issued in private placements that closed in September 2005, August 2006, August
2007, and March 2008.





Pursuant
to the Consent and Amendment:





·
            The
      Company agreed to issue to each Holder in exchange for such Holder’s
      Debenture an amended and restated Debenture (the “Amended and Restated
      Debentures”) in a principal amount equal to the principal amount of such
      Holder’s Debenture times 1.35 minus any interest paid
    thereon.





·
            The
      conversion price under the Amended and Restated Debentures was reduced to
      $0.10, subject to further adjustment as provided therein (including for
      stock splits, stock dividends, and certain subsequent equity
      sales).





·
            The
      maturity date under the Amended and Restated Debentures was extended until
      December 31, 2010.




·
            The
      Company agreed to amend and restate each Holder’s Warrant (the “Amended
      and Restated Warrants”).





·
            The
      exercise price under the Amended and Restated Warrants was reduced to
      $0.10 subject to further adjustment as provided therein (including for
      stock splits, stock dividends, and certain subsequent equity
      sales).





·
            The
      termination date under the Amended and Restated Warrants was extended
      until June 30, 2014.







ITEM
3. DEFAULTS UPON SENIOR SECURITIES




None.




ITEM
4. SUBMISSION OF MATTERS TO A VOTE OF SECURITY HOLDERS




On August
11, 2009, our Board of Directors filed a definitive proxy statement with the
Securities and Exchange Commission relating to the following
proposals:





1.
            To
      consider and act upon a proposal to approve an amendment to the Company’s
      2005 Stock Incentive Plan to increase the number of shares issuable
      thereunder to a total of 145,837,250 shares;
and


2.
            To
      consider and act upon a proposal to approve an amendment to the
      Certificate of Incorporation of the Company to effect an increase in the
      authorized shares of common stock, par value $0.001 of the Company from
      500,000,000 to 1,750,000,000.





These
matters were submitted for a vote and approved during a special meeting of
stockholders on September 10, 2009.




60




ITEM
5. OTHER INFORMATION





Effective
March 3, 2009, we entered into a $5 million credit facility (“Facility”) with a
life sciences fund. Under the terms of the agreement, we may draw down funds, as
needed, from the investor through the issuance of Series A-1 convertible
preferred stock, par value $.001, at a basis of 1 share of Series A-1
convertible preferred stock for every $10,000 invested. The preferred stock pays
dividends, in kind of preferred stock, at an annual rate of 10%, matures in four
years from the initial drawdown date, and is convertible at the option of the
holder into common stock at $0.75 per share. Upon the earlier of (i) the fourth
anniversary of the issuance date, and (ii) the occurrence of a major
transaction, each holder shall have the right, at such holder’s option, to
require the Company to redeem all or a portion of such holder’s share of Series
A-1 preferred stock, at a price per share equal to the Series A-1 liquidation
value. A major transaction includes (i) the consolidation, merger, or other
business combination of the Company with or into another entity, (ii) the sale
or transfer of more than 50% of the Company’s assets other than inventory in the
ordinary course of business in one or more related series of transactions, or
(iii) closing of a purchase, tender or exchange offer made  to the
holders of more than 50% of the outstanding shares of common stock in which more
than 50% of the outstanding shares of common stock were tendered and accepted.
The Company shall have the right, at the Company’s option, to redeem all or a
portion of the shares of Series A-1 preferred stock, at any time at a price per
share of Series A-1 preferred stock equal to 100% of the Series A-1 liquidation
value. In the event the closing price of the our common stock during the 5
trading days following the put notice falls below 75% of the average of the
closing bid price in the 5 trading days prior to the put closing date, the
investor may, at its option, and without penalty, decline to purchase the
applicable put shares on the put closing date. We may terminate the agreement
and our right to initiate future draw-downs by providing 30 days advanced
written notice to the investor. Upon any liquidation, dissolution or winding up
of the Company, whether voluntary or involuntary, after payment or provision for
payment of debts and other liabilities of the Corporation, before any
distribution or payment shall be made to the holders of any other equity
securities of the Company by reason of their ownership thereof, the holders of
the Series A-1 preferred stock shall first be entitled to be paid out of the
assets of the Company available for distribution to its stockholders an amount
with respect to each share of Series A-1 preferred stock equal to $10,000, plus
any accrued by unpaid dividends. If, upon dissolution or winding up of the
Company, the assets of the Company shall be insufficient to make payment in full
to all holders, then such assets shall be distributed among the holders at the
time outstanding, ratably in proportion to the full amounts to which they would
otherwise be respectively entitled.





Conditions
precedent to the Company’s right to deliver a put notice:





·
            The
      common stock shall be listed for and actively trading on a trading market,
      and to the Company’s knowledge there is no notice of any suspension or
      delisting with respect to the trading of the shares of common stock on
      such market or exchange;


·
            The
      representations and warranties of the Company set forth in the agreement
      are true and correct in all material respects as if made on such date, and
      no default shall have occurred under the agreement, or any other agreement
      with the investor, or investor affiliate, and the Company shall deliver an
      Officer’s Closing Certificate, signed by an officer of the Company, to
      such effect, to the investor;


·
            The
      Company has timely filed (or obtained extension in respect thereof and
      filed within the applicable grace period) all reports to be filed by the
      Company pursuant to the exchange
agreement;


·
            There
      have been no material changes in the Company’s business prospects or
      financial condition since the investment commitment closing, including but
      not limited to incurring material
liabilities;


·
            Except
      for the debenture agreements, the Company is not, and will not be as a
      result of the applicable put, in default of any material
      agreement;


·
            There
      is no current legal action against the Company whereby the transaction
      would be affected, of which the investor has not been made
      aware;


·
            Except
      with prior approval of the investor, the proceeds from the facility shall
      be used only for the purposes of advancement of the Company’s Retinal
      Pigment Epithelial (RPE) Program for the treatment of macular degeneration
      and other retinal degenerative
diseases;


·
            All
      DWAC shares are DTC eligible and can be immediately converted into
      electronic form without restrictions on resale;
  and


·
            The
      Company has a sufficient number of duly authorized shares of common stock
      for issuance in such amount as may be required to fulfill its obligations
      pursuant to its outstanding agreements with the investor or any investor
      affiliate.




On  October
19, 2009, the Company entered into two letter agreements with Volation Life
Sciences Capital Partners, LLC (“Volation”), pursuant to which (i) the Company
reduced the conversion price of its outstanding Series A-1 convertible preferred
stock issued to Volation to $.10 per share resulting in 22,880,000 shares of
Common Stock upon conversion, (ii) issued Volation 2,500,000 shares of its
Common Stock at $0.10 per share in payment of an outstanding commitment fee, and
(iii) Volation waived the delinquency in  non-payment of the $250,000
commitment fee required pursuant to the preferred stock purchase agreement
between the Company and Volation.


61





ITEM
6. EXHIBITS




Exhibit Description




10.1
                                          Consent,
      Amendment and Exchange Agreement, dated July 29, 2009, between Advanced
      Cell Technology, Inc. and the Holders named therein (filed as an exhibit
      to the Company’s 8K filed on August 4, 2009 and incorporated herein by
      reference).10.2
                                          Standstill
      and Forbearance Agreement, dated July 29, 2009, between Advanced Cell
      Technology, Inc. and the Holders named therein (filed as an exhibit to the
      Company’s 8K filed on August 4, 2009 and incorporated herein by
      reference).31.1
                                          Section 302
      Certification of Principal Executive Officer and Principal Financial
      Officer.*32.1
                                          Certification
      of Principal Executive Officer and Principal Financial Officer pursuant to
      18 U.S.C. Section 1350.*












*
            Filed
      herewith


62





SIGNATURE





Pursuant
to the requirements of the Securities Exchange Act of 1934, the Registrant has
duly caused this report to be signed on its behalf by the undersigned hereunto
duly authorized.




ADVANCED
      CELL TECHNOLOGY, INC.By:
                /s/
      William M. Caldwell, IVWilliam
      M. Caldwell, IVChief
      Executive Officer (Principal Executive Officer and Principal Financial
      Officer)Dated:
      November 16, 2009


63