##### Table of Contents



U.S. SECURITIES AND EXCHANGE COMMISSION
 WASHINGTON, D.C. 20549
 FORM 10-KSB/A
  þ
    
    ANNUAL REPORT PURSUANT TO SECTION 13 OR 15(D) OF THE SECURITIES 
EXCHANGE ACT OF 1934
 FOR THE FISCAL YEAR ENDED DECEMBER 31, 2004
 o
    
    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 0-27689
 AMDL, Inc.
  Delaware
    
    33-0413161(State or other jurisdiction of
    
    (IRS Employer Identification No.)incorporation or organization)
 2492 Walnut Avenue, Suite 100, Tustin, California 92780
   (Issuers telephone number)
  Title of each class
    
    Name of each exchange on whichto be so registered
    
    registeredCommon Stock, $.001 par value
    
    AMEX
  Common Stock, $.001 par value
   þ o
 þ
 o þ
    DOCUMENTS INCORPORATED BY REFERENCE
   o þ




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TABLE OF CONTENTS  Part 1Item 1. Description of BusinessItem 2. Description of PropertiesItem 3. Legal ProceedingsItem 4. Submission of Matters to a Vote of Security HoldersPart IIItem 5. Market for Common Equity and Related Stockholder MattersItem 6. Managements Discussion and Analysis of Financial Condition and Results of OperationsItem 7. Financial StatementsItem 8. Changes in and Disagreements with Accountants on Accounting and Financial DisclosureItem 8A. Controls and ProceduresPart IIIItem 9. Directors and Executive Officers of the Registrant.Item 10. Executive Compensation.Item 11. Security Ownership of Certain Beneficial Owners and Management.Item 12. Certain Relationships and Related Transactions.Item 13. Exhibits.Item 14. Principal Accountant Fees and ServicesSIGNATURESEXHIBIT INDEXEXHIBIT 31.1EXHIBIT 31.2EXHIBIT 32.1EXHIBIT 32.2    Table of Contents  
 Part 1
 
 Item 1. Description of Business
 ® ® ® ® ® ® ® ® ® ®
    1




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Our Products
 â â ®
 â â
 2




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â â â
 ® â â â
 ® â Alimentary Pharmacology & Therapeutics ® ®
 in vitro
  3




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##### Table of Contents



Our Strategy
 H. pylori
 ® â â â â
 ® ® ®
  
    
    obtain U.S. FDA clearance and international approvals for our DR-70® product;
    
    distribute DR-70® kits in approved markets;
    
    develop DR-70® distribution channels in new markets; and
    
    contract with one or more strategic partners to license and develop our combination
immunogene therapy technology.
 S ®
 
    
    the product candidate did not demonstrate acceptable clinical trial results even
though it demonstrated positive preclinical trial results;
    
    the product candidate was not effective in treating a specified condition or illness;
    
    the product candidate had harmful side effects on humans;
    
    the necessary regulatory bodies, such as the U.S. FDA, did not approve the product
candidate for an intended use;
    
    the product candidate was not economical for us to manufacture and commercialize; and
    
    the product candidate is not cost effective in light of existing therapeutics.
 4




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®
 Sales and Marketing
 ® ®
 â â
 â â
 â
 Ò â â
  5




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Manufacturing
 â
 Regulation
  ® â
 ® ® ® ® â
  6




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##### Table of Contents



â â
 Ô Ô Ô Ô
 ®
  â
     7




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##### Table of Contents



Research and Development
 ® ®
 Competition
 ® ®
 â â
 Product Liability Insurance
  Employees
  
 Item 2. Description of Properties
  8




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##### Table of Contents



Item 3. Legal Proceedings
    
 Item 4. Submission of Matters to a Vote of Security Holders
  
 Part II
 
 Item 5. Market for Common Equity and Related Stockholder Matters
  
    
    clinical trial results;
    
    product development announcements by us or our competitors;
    
    regulatory matters;
    
    announcements in the scientific and research community;
    
    intellectual property and legal matters; and
    
    broader industry and market trends unrelated to our performance.
 9




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##### Table of Contents



Quarter Ended
    
    High
    
    
    LowMarch 31, 2003
    
    $
    0.70
    
    
    $
    0.20June 30, 2003
    
    $
    1.25
    
    
    $
    0.23September 30, 2003
    
    $
    2.20
    
    
    $
    0.76December 31, 2003
    
    $
    1.65
    
    
    $
    1.01
 Quarter Ended
    
    High
    
    
    LowMarch 31, 2004
    
    $
    1.71
    
    
    $
    0.93June 30, 2004
    
    $
    1.13
    
    
    $
    0.76September 30, 2004
    
    $
    1.00
    
    
    $
    0.56December 31, 2004
    
    $
    1.23
    
    
    $
    0.78
   Securities Authorized for Issuance Under Equity Compensation Plans.
 (c)Number of securitiesremaining available(a)
    
    (b)
    

    for future issuancesNumber of securities
    
    Weighed-average
    
    under equityto be issued upon
    
    exercise price of
    
    compensation plansexercise of
    
    outstanding
    
    (excluding securitiesoutstanding options,
    
    options, warrants
    
    reflected inPlan Category
    
    warrants and rights
    
    and rights
    
    column (a))Equity compensation plans
approved by security holders
    
    
    4,318,185
    
    
    $
    1.46
    
    
    
    836,261Equity compensation plans not
approved by security holders
    
    
    -0-
    
    
    
    -0-
    
    
    
    -0-Total
    
    
    4,318,185
    
    
    $
    1.46
    
    
    
    836,261
  Voting Trust Agreement ® ®
 10




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##### Table of Contents



Recent Sales of Unregistered Securities
    11




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##### Table of Contents



Item 6. Managements Discussion and Analysis of Financial Condition and Results of Operations
 Liquidity and Capital Resources
   ®
 ® ®
  Critical Accounting Policies
   Allowance for Doubtful Accounts
 12




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Inventory
 Sales Allowances.
 Valuation of Intangibles
 Deferred Taxes
 Litigation
 13




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Results of Operations
 Year Ended December 31, 2004 Compared to Year Ended December 31, 2003
 Net Revenue. ® ® ®
 ® ® ®
 ® ®
 Gross Profit. ®
  Research and Development.
 14




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##### Table of Contents



General and Administrative Expenses.
 Interest Income and Expense.
 Net Loss and Loss from Operations.
 Assets and Liabilities
     Forward Looking Statements
 ®
 15




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##### Table of Contents



Item 7. Financial Statements
 Report of Independent Registered Public Accounting Firm
    
    F-1Balance Sheet as of December 31, 2004
    
    F-2Statements of Operations for the years ended December 31, 2004 and 2003
    
    F-3Statements of Stockholders Equity for the years ended
December 31, 2004 and 2003
    
    F-4Statements of Cash Flows for the years ended December 31, 2004 and 2003
    
    F-6Notes to Financial Statements
    
    F-7
 16




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##### Table of Contents



CORBIN & COMPANY, LLPIrvine, CaliforniaMarch 7, 2005
 F-1




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##### Table of Contents



AMDL, INC.
 BALANCE SHEET
 December 31,2004ASSETSCurrent assets:Cash and cash equivalents
    
    $
    2,605,537Inventories
    
    
    68,035Prepaid expenses
    
    
    52,201Total current assets
    
    
    2,725,773Intellectual property, net
    
    
    1,658,333Property and equipment, net
    
    
    13,888Other assets
    
    
    5,757$
    4,403,751LIABILITIES AND STOCKHOLDERS EQUITYCurrent liabilities:Accounts payable and accrued expenses
    
    $
    83,761Accrued payroll and related expenses
    
    
    81,612Total current liabilities
    
    
    165,373Commitments and contingenciesStockholders equity:Preferred stock, $0.001 par value; 10,000,000 shares
authorized; no shares issued and outstanding
    
    
    Common stock, $0.001 par value; 50,000,000 shares
authorized; 23,499,489 shares issued and outstanding
    
    
    23,499Additional paid-in capital
    
    
    30,375,929Accumulated deficit
    
    
    (26,161,050
    )Total stockholders equity
    
    
    4,238,378$
    4,403,751




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##### Table of Contents



AMDL, INC.
 STATEMENTS OF OPERATIONS
 Years EndedDecember 31,
    
    
    December 31,2004
    
    
    2003Net revenues
    
    $
    186,182
    
    
    $
    360,107Cost of sales
    
    
    72,695
    
    
    
    167,069Gross profit
    
    
    113,487
    
    
    
    193,038Operating expenses:Research and development
    
    
    292,652
    
    
    
    545,599General and administrative
    
    
    2,476,740
    
    
    
    2,041,7862,769,392
    
    
    
    2,587,385Loss from operations
    
    
    (2,655,905
    )
    
    
    (2,394,347
    )Other income (expense):Interest income
    
    
    26,544
    
    
    
    1,119Interest expense
    
    
    
    
    
    
    (480,467
    )26,544
    
    
    
    (479,348
    )Net loss
    
    $
    (2,629,361
    )
    
    $
    (2,873,695
    )Basic and diluted loss available to common
stockholders per common share
    
    $
    (0.12
    )
    
    $
    (0. 23
    )Weighted average common shares outstanding,
basic and diluted
    
    
    21,829,371
    
    
    
    12,693,847




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##### Table of Contents



AMDL, INC.
 STATEMENTS OF STOCKHOLDERS EQUITY
 For The Years Ended December 31, 2004 and 2003
 AdditionalCommon Stock
    
    
    Preferred Stock
    
    
    Paid-in
    
    
    AccumulatedShares
    
    
    Amount
    
    
    Shares
    
    
    Amount
    
    
    Capital
    
    
    Deficit
    
    
    TotalBalance, January 1, 2003
    
    
    9,106,656
    
    
    $
    9,107
    
    
    
    
    
    
    $
    
    
    
    $
    22,839,605
    
    
    $
    (20,657,994
    )
    
    $
    2,190,718Common stock issued for cash (including
95,000 shares of common stock issued to finders),
net of cash offering costs of $207,627
    
    
    1,437,700
    
    
    
    1,438
    
    
    
    
    
    
    
    
    
    
    
    850,935
    
    
    
    
    
    
    
    852,373Common stock issued on conversion of notes
and accrued interest
    
    
    3,565,603
    
    
    
    3,566
    
    
    
    
    
    
    
    
    
    
    
    1,262,757
    
    
    
    
    
    
    
    1,266,323Common stock issued for consulting services
    
    
    761,666
    
    
    
    761
    
    
    
    
    
    
    
    
    
    
    
    428,630
    
    
    
    
    
    
    
    429,391Common stock issued for warrants and options
exercised (including 100,000 shares of common
stock issued to consultants), net of cash offering
costs of $148,741
    
    
    3,840,138
    
    
    
    3,840
    
    
    
    
    
    
    
    
    
    
    
    1,299,446
    
    
    
    
    
    
    
    1,303,286Estimated fair market value of options and
warrants granted to third parties and
beneficial conversion feature on convertible
note financing
    
    
    
    
    
    
    
    
    
    
    
    
    
    
    
    
    
    
    225,648
    
    
    
    
    
    
    
    225,648Net loss
    
    
    
    
    
    
    
    
    
    
    
    
    
    
    
    
    
    
    
    
    
    
    (2,873,695
    )
    
    
    (2,873,695
    )Balance, December 31, 2003
    
    
    18,711,763
    
    
    $
    18,712
    
    
    
    
    
    
    $
    
    
    
    $
    26,907,021
    
    
    $
    (23,531,689
    )
    
    $
    3,394,044




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##### Table of Contents



AMDL, INC.
 STATEMENTS OF STOCKHOLDERS EQUITY (Continued)
 For The Years Ended December 31, 2004 and 2003
 AdditionalCommon Stock
    
    
    Preferred Stock
    
    
    Paid-in
    
    
    AccumulatedShares
    
    
    Amount
    
    
    Shares
    
    
    Amount
    
    
    Capital
    
    
    Deficit
    
    
    TotalBalance, December 31, 2003
    
    
    18,711,763
    
    
    $
    18,712
    
    
    
    
    
    
    $
    
    
    
    $
    26,907,021
    
    
    $
    (23,531,689
    )
    
    $
    3,394,044Common stock issued for cash,
net of cash offering costs of $492,489
    
    
    4,264,041
    
    
    
    4,264
    
    
    
    
    
    
    
    
    
    
    
    2,866,277
    
    
    
    
    
    
    
    2,870,541Common stock issued for consulting services
    
    
    300,000
    
    
    
    300
    
    
    
    
    
    
    
    
    
    
    
    247,050
    
    
    
    
    
    
    
    247,350Common stock issued for options exercised
    
    
    223,685
    
    
    
    223
    
    
    
    
    
    
    
    
    
    
    
    162,081
    
    
    
    
    
    
    
    162,304Estimated fair market value of options and
warrants granted to third parties
for consulting services
    
    
    
    
    
    
    
    
    
    
    
    
    
    
    
    
    
    
    193,500
    
    
    
    
    
    
    
    193,500Net loss
    
    
    
    
    
    
    
    
    
    
    
    
    
    
    
    
    
    
    
    
    
    
    (2,629,361
    )
    
    
    (2,629,361
    )Balance, December 31, 2004
    
    
    23,499,489
    
    
    $
    23,499
    
    
    
    
    
    
    $
    
    
    
    $
    30,375,929
    
    
    $
    (26,161,050
    )
    
    $
    4,238,378




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##### Table of Contents



AMDL, INC.
 STATEMENTS OF CASH FLOWS
 Years EndedDecember 31,
    
    
    December 31,2004
    
    
    2003Cash flows from operating activitiesNet loss
    
    $
    (2,629,361
    )
    
    $
    (2,873,695
    )Adjustments to reconcile net loss to net cash
used in operating activities:Depreciation and amortization
    
    
    108,483
    
    
    
    109,988Common stock issued for services
    
    
    247,350
    
    
    
    276,391Warrants and options issued for services
    
    
    193,500
    
    
    
    2,950Non-cash interest expense recognized
    
    
    
    
    
    
    479,318Changes in operating assets and liabilities:Accounts receivable
    
    
    152,967
    
    
    
    (64,577
    )Inventories
    
    
    790
    
    
    
    14,149Prepaid expenses and other current assets
    
    
    (21,969
    )
    
    
    (10,704
    )Accounts payable and accrued expenses
    
    
    (176,881
    )
    
    
    115,955Accrued payroll and related expenses
    
    
    10,284
    
    
    
    5,348Customer deposits
    
    
    
    
    
    
    (12,350
    )Net cash used in operating activities
    
    
    (2,135,405
    )
    
    
    (1,957,227
    )Cash flows from investing activities
Purchase of property and equipment
    
    
    (789
    )
    
    
    Cash flows from financing activitiesProceeds from issuance of common stock,
net of cash offering costs of $492,489
in 2004 and $207,627 in 2003
    
    
    2,870,541
    
    
    
    852,373Proceeds from the exercise of warrants and options,
net of cash offering costs of
$0 in 2004 and $148,741 in 2003
    
    
    162,304
    
    
    
    1,303,286Proceeds from issuance of convertible notes,
net of cash offering costs of $0 in
2004 and $263,295 in 2003
    
    
    
    
    
    
    1,162,702Net cash provided by financing activities
    
    
    3,032,845
    
    
    
    3,318,361Net change in cash and cash equivalents
    
    
    896,651
    
    
    
    1,361,134Cash and cash equivalents, beginning of year
    
    
    1,708,886
    
    
    
    347,752Cash and cash equivalents, end of year
    
    $
    2,605,537
    
    
    $
    1,708,886Supplemental disclosure of cash flow information:Cash paid during the year for interest
    
    $
    
    
    
    $
    1,052Cash paid during the year for taxes
    
    $
    800
    
    
    $
    800




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##### Table of Contents



AMDL, INC.
 NOTES TO FINANCIAL STATEMENTS
 For The Years Ended December 31, 2004 and 2003
 NOTE 1  ORGANIZATION AND SUMMARY OF SIGNIFICANT ACCOUNTING POLICIES
 Nature of Business
  â
 Revenue Recognition
  Advertising
  Research and Development
  Cash Equivalents
  Inventories
  Property and Equipment
   F-7




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##### Table of Contents



AMDL, INC.
 NOTES TO FINANCIAL STATEMENTS
 For The Years Ended December 31, 2004 and 2003
 Intangible Assets
   Impairment of Long-Lived Assets
  
    
    significant under performance relative to expected historical or projected future operating results;
    
    market projections for cancer research technology;
    
    its ability to obtain patents, including continuation patents, on technology;
    
    significant changes in its strategic business objectives and utilization of the assets;
    
    significant negative industry or economic trends, including legal factors; and
    
    potential for strategic partnerships for the development of its patented technology.
  Common Stock Issued for Services Rendered
  F-8




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##### Table of Contents



AMDL, INC.
 NOTES TO FINANCIAL STATEMENTS
 For The Years Ended December 31, 2004 and 2003
 Risks and Uncertainties
 â
 â â â â â â
  Accounting for Stock-Based Compensation
     F-9




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##### Table of Contents



AMDL, INC.
 NOTES TO FINANCIAL STATEMENTS
 For
The Years Ended December 31, 2004 and 2003
   F-10




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##### Table of Contents



AMDL, INC.
 NOTES TO FINANCIAL STATEMENTS
 For The Years Ended December 31, 2004 and 2003
 Year ended December 31,2004
    
    
    2003Net loss as reported
    
    $
    (2,629,361
    )
    
    $
    (2,873,695
    )Deduct: Total stock-based employee
compensation under fair value based method
for all awards, net of related tax effects
    
    
    (1,094,200
    )
    
    
    (322,948
    )Pro forma net loss
    
    $
    (3,723,561
    )
    
    $
    (3,196,643
    )Basic and diluted loss per share  as reported
    
    $
    (0.12
    )
    
    $
    (0.23
    )Basic and diluted loss per share  pro forma
    
    $
    (0.17
    )
    
    $
    (0.25
    )
  Basic and Diluted Loss Per Share
  Income Taxes
  Use of Estimates
  F-11




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##### Table of Contents



AMDL, INC.
 NOTES TO FINANCIAL STATEMENTS
 For The Years Ended December 31, 2004 and 2003
 Fair Value of Financial Instruments
  Comprehensive Income
  Segments of an Enterprise and Related Information
  Concentration of Risk
   Recent Accounting Pronouncements
  Inventory
Costs, an amendment of ARB No. 43, Chapter 4,
 F-12




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##### Table of Contents



AMDL, INC.
 NOTES TO FINANCIAL STATEMENTS
 For The Years Ended December 31, 2004 and 2003
   Exchange of Nonmonetary Assets  an amendment of
APB Opinion No 29, Accounting for Nonmonetary Transactions
 NOTE 2  INVENTORIES
  Raw materials
    
    $
    51,047Work-in-process
    
    
    14,477Finished goods
    
    
    2,511$
    68,035
 NOTE 3  PROPERTY AND EQUIPMENT
  Office equipment
    
    $
    38,164Lab equipment
    
    
    5,97944,143Less accumulated depreciation
    
    
    (30,255
    )$
    13,888
  F-13




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##### Table of Contents



AMDL, INC.
 NOTES TO FINANCIAL STATEMENTS
 For The Years Ended December 31, 2004 and 2003
 NOTE 4  INTELLECTUAL PROPERTY
  Purchased patent pending technology
    
    $
    2,000,000Accumulated amortization
    
    
    (341,667
    )$
    1,658,333
  Years Ending2004
    
    $
    100,0002005
    
    
    100,0002006
    
    
    100,0002007
    
    
    100,0002008
    
    
    100,000
   NOTE 5  INCOME TAXES
  Deferred tax asset:Net operating loss carryforward
    
    $
    9,170,000Expenses recognized for granting of options and warrants
    
    
    672,000Total gross deferred tax asset
    
    
    9,842,000Less valuation allowance
    
    
    (9,842,000
    )Net deferred tax asset
    
    $
    
  F-14




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##### Table of Contents



AMDL, INC.
 NOTES TO FINANCIAL STATEMENTS
 For The Years Ended December 31, 2004 and 2003
  2004
    
    
    2003Computed tax benefit at federal statutory rate
    
    $
    (894,000
    )
    
    $
    (976,000
    )State income tax benefit, net of federal effect
    
    
    (158,000
    )
    
    
    (172,000
    )Increase in valuation allowance
    
    
    1,052,000
    
    
    
    1,148,000Other
    
    
    800
    
    
    
    800$
    800
    
    
    $
    800
   NOTE 6  COMMITMENTS AND CONTINGENCIES
 Operating Lease
  Years EndingDecember 31,2005
    
    $
    45,000
  Litigation
  F-15




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##### Table of Contents



AMDL, INC.
 NOTES TO FINANCIAL STATEMENTS
 For The Years Ended December 31, 2004 and 2003
    Change in Control Severance Plan
     Consulting Agreements
  F-16




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##### Table of Contents



AMDL, INC.
 NOTES TO FINANCIAL STATEMENTS
 For The Years Ended December 31, 2004 and 2003
  Licensing Agreements
 â
 Indemnities and Guarantees
  NOTE 7  STOCK OPTIONS
   F-17




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AMDL, INC.
 NOTES TO FINANCIAL STATEMENTS
 For The Years Ended December 31, 2004 and 2003
    2004
    
    
    2003Weighted
    
    
    
    
    
    
    WeightedAverage
    
    
    
    
    
    
    AverageExercise
    
    
    
    
    
    
    ExerciseOptions
    
    
    Price
    
    
    Options
    
    
    PriceOutstanding,
beginning of year
    
    
    3,000,000
    
    
    $
    1.51
    
    
    
    2,676,630
    
    
    $
    1.62Granted
    
    
    1,870,000
    
    
    
    1.15
    
    
    
    552,370
    
    
    
    1.10Exercised
    
    
    (223,685
    )
    
    
    (0.73
    )
    
    
    
    
    
    
    Expired/forfeited
    
    
    (328,130
    )
    
    
    (0.68
    )
    
    
    (229,000
    )
    
    
    (1.87
    )Outstanding and exercisable,
end of year
    
    
    4,318,185
    
    
    $
    1.46
    
    
    
    3,000,000
    
    
    $
    1.51Weighted average fair value
of options granted
    
    
    
    
    
    $
    0.61
    
    
    
    
    
    
    $
    0.59
  F-18




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##### Table of Contents



AMDL, INC.
 NOTES TO FINANCIAL STATEMENTS
 For The Years Ended December 31, 2004 and 2003
 WeightedAverageNumber of
    
    RemainingOptioned
    
    ContractualExercise Price
    
    Shares
    
    Life (Years)$4.00
    
    
    475,000
    
    
    
    1.7$2.39
    
    
    50,000
    
    
    
    2.4$2.25
    
    
    177,000
    
    
    
    2.0$2.00
    
    
    25,000
    
    
    
    0.3$1.75
    
    
    345,000
    
    
    
    0.1$1.23
    
    
    1,395,000
    
    
    
    4.2$1.10
    
    
    516,185
    
    
    
    4.0$1.00
    
    
    165,000
    
    
    
    0.8$0.97
    
    
    5,000
    
    
    
    4.3$0.93
    
    
    470,000
    
    
    
    4.8$0.48
    
    
    695,000
    
    
    
    2.6
  NOTE 8  STOCK WARRANTS
     F-19




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AMDL, INC.
 NOTES TO FINANCIAL STATEMENTS
 For The Years Ended December 31, 2004 and 2003
      F-20




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AMDL, INC.
 NOTES TO FINANCIAL STATEMENTS
 For The Years Ended December 31, 2004 and 2003
  2004
    
    
    2003WeightedWeighted
    
    
    
    
    
    
    AverageAverage
    
    
    
    
    
    
    ExerciseWarrants
    
    
    Exercise Price
    
    
    Warrants
    
    
    PriceOutstanding,
beginning of year
    
    
    754,908
    
    
    $
    0.77
    
    
    
    668,806
    
    
    $
    1.99Granted
    
    
    4,205,795
    
    
    
    1.24
    
    
    
    4,326,240
    
    
    
    0.45Expired/forfeited
    
    
    (143,806
    )
    
    
    (0.68
    )
    
    
    (500,000
    )
    
    
    (2.45
    )Exercised
    
    
    
    
    
    
    
    
    
    
    (3,740,138
    )
    
    
    (0.39
    )Outstanding and exercisable,
end of year
    
    
    4,816,897
    
    
    $
    1.19
    
    
    
    754,908
    
    
    $
    0.77Weighted average fair value
of warrants granted
    
    
    
    
    
    $
    0.63
    
    
    
    
    
    
    $
    0.42
  WeightedAverageNumber of
    
    RemainingWarranted
    
    ContractualExercise Price
    
    Shares
    
    Life (Years)$1.58
    
    
    205,620
    
    
    
    1.0$1.46
    
    
    1,588,380
    
    
    
    2.0$1.17
    
    
    1,767,415
    
    
    
    4.0$1.09
    
    
    250,000
    
    
    
    2.6$0.99
    
    
    250,000
    
    
    
    2.6$0.94
    
    
    250,000
    
    
    
    2.6$0.92
    
    
    100,000
    
    
    
    2.6$0.39
    
    
    205,482
    
    
    
    2.0$0.39
    
    
    200,000
    
    
    
    1.4
  NOTE 9  STOCKHOLDERS EQUITY
 Preferred Stock
   F-21




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AMDL, INC.
 NOTES TO FINANCIAL STATEMENTS
 For The Years Ended December 31, 2004 and 2003
 Common Stock
 Cash Financing Activities
     F-22




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AMDL, INC.
 NOTES TO FINANCIAL STATEMENTS
 For The Years Ended December 31, 2004 and 2003
      F-23




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AMDL, INC.
 NOTES TO FINANCIAL STATEMENTS
 For The Years Ended December 31, 2004 and 2003
        F-24




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AMDL, INC.
 NOTES TO FINANCIAL STATEMENTS
 For The Years Ended December 31, 2004 and 2003
    Non-Cash Financing Activities
     F-25




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AMDL, INC.
 NOTES TO FINANCIAL STATEMENTS
 For The Years Ended December 31, 2004 and 2003
  NOTE 10  EARNINGS PER SHARE
  2004
    
    
    2003Numerator for basic and diluted earnings per shareNet loss available to common stockholders
    
    $
    (2,629,361
    )
    
    $
    (2,873,695
    )Denominator for basic and diluted earnings per shareWeighted average shares
    
    
    21,829,371
    
    
    
    12,693,847Basic and diluted loss per share
    
    $
    (0.12
    )
    
    $
    (0.23
    )
 NOTE 11  RELATED PARTY TRANSACTIONS
 ®
 NOTE 12  SUBSEQUENT EVENTS
  F-26




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Item 8. Changes in and Disagreements with Accountants on Accounting and Financial Disclosure
 
  
 Item 8A. Controls and Procedures
 Evaluation of Disclosure Controls and Procedures
  Changes in Internal Controls
  
 Part III
 
 Item 9. Directors and Executive Officers of the Registrant.
  Year FirstName
    
    Age
    
    Elected
    
    PositionWilliam M. Thompson III, M.D.
    
    76
    
    1989
    
    Chairman of the board of directorsGary L. Dreher
    
    58
    
    1999
    
    President, Chief Executive Officer, Secretary and DirectorDouglas C. MacLellan
    
    49
    
    1992
    
    DirectorEdward R. Arquilla, M.D., Ph.D.
    
    82
    
    1997
    
    DirectorMarvin E. Rosenthale, Ph.D.
    
    71
    
    2002
    
    Director
   17




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##### Table of Contents



Board of Directors Meetings and Committees
   Arthur S. Rosten, Age 57, Chief Financial Officer.
 18




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Section 16(a) Beneficial Ownership Reporting Compliance
   Code of Ethics for Financial Professionals
  
 Item 10. Executive Compensation.
 Cash Compensation of Executive Officers
 Long-TermAnnual Compensation
    
    CompensationOther
    
    Common SharesAwards
    
    Underlying Options
    
    All OtherName and Position
    
    Year
    
    Salary ($)
    
    Bonus ($)
    
    Compensation ($)
    
    Granted (#)
    
    Compensation ($)Gary L. Dreher,
    
    
    2004
    
    
    $
    373,750
    (1)
    
    
    -0-
    
    
    $
    18,000
    (2)
    
    
    950,000
    
    
    
    -0-President and CEO
    
    
    2003
    
    
    $
    330,000
    (1)
    
    
    -0-
    
    
    $
    17,856
    (2)
    
    
    245,000
    
    
    
    -0-2002
    
    
    $
    325,000
    (1)
    
    
    -0-
    
    
    $
    28,893
    (2)
    
    
    450,000
    
    
    
    -0-Arthur S. Rosten,
    
    
    2004
    
    
    $
    175,000
    (3)
    
    $
    8,000
    
    
    
    -0-
    
    
    
    75,000
    
    
    
    -0-Chief Financial Officer
    
    
    2003
    
    
    $
    175,000
    (3)
    
    $
    8,000
    
    
    
    -0-
    
    
    
    70,000
    
    
    
    -0-2002
    
    
    $
    162,240
    (3)
    
    
    -0-
    
    
    
    -0-
    
    
    
    79,000
    
    
    
    -0-
 
 (1)
    
    Effective March 1, 2002, Mr. Drehers compensation was raised from $300,000 to $330,000 per
annum. Effective May, 1, 2004 Mr. Drehers compensation was raised to $400,000 per annum.(2)
    
    The 2004 amount represents $4,644 for golf membership dues, $9,000 for a car allowance and
$4,356 for life insurance. The 2003 amount represents $4,500 for golf membership dues, $9,000
for a car allowance and $4,356 for life insurance. The 2002 amount represents an additional
payment of $8,880 in respect of taxes on the 2001 purchase of the golf club membership, $8,835
for golf membership dues and other items, $9,000 for a car allowance and $2,178 for life
insurance.(3)
    
    On December 1, 2001, Mr. Rosten became our Chief Financial Officer on a part-time basis at a
monthly salary of $7,291. Effective March 1, 2002, Mr. Rosten began serving on a full-time
basis at an annual salary of $175,000. 19




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##### Table of Contents



OPTION GRANTS IN LAST FISCAL YEAR
 Individual Grants
 % of Total OptionsNumber of Securities
    
    Granted toUnderlying Options
    
    Employees in Fiscal
    
    Exercise or BaseName
    
    Granted
    
    Year(3)
    
    Price ($/Sh)
    
    Expiration DateGary L. Dreher,
    
    
    950,000
    (1)
    
    
    84.4
    %
    
    
    (1
    )
    
    
    (1
    )President and CEOArthur S. Rosten,
    
    
    75,000
    (2)
    
    
    6.7
    %
    
    
    (2
    )
    
    
    (2
    )Chief Financial Officer
 
 (1)
    
    Includes 81,300 options granted as incentive stock options and 618,700 options
granted as non-qualified stock options under our 2004 stock option plan all exercisable at
$1.23 per share and expiring on February 23, 2009 and 250,000 options granted as non-qualified
stock options under our 2004 stock option plan exercisable at $0.93 per share and expiring on
October 7, 2009. All of these options are fully vested and became exercisable on the date of
grant.(2)
    
    Includes 70,000 options granted as incentive stock options under our 2004 stock
option plan exercisable at $1.23 per share and expiring on February 23, 2009 and 5,000 options
granted as incentive stock options under our 2004 stock option plan exercisable at $0.97 per
share and expiring on April 16, 2009. All of these options are fully vested and became
exercisable on the date of grant.(3)
    
    Based on an aggregate of 1,125,000 options granted to employees in fiscal 2004. AGGREGATED OPTION EXERCISES IN LAST FISCAL YEAR AND FY-END OPTION VALUES
 Number of SecuritiesUnderlying Unexercised
    
    Value of Unexercised In-the-MoneyShares Acquired on
    
    
    
    
    
    Options at FY-End (#)
    
    Options at FY-End ($)Name
    
    Exercise (#)
    
    Value Realized ($)
    
    Exercisable/Unexerciseable
    
    Exercisable/Unexercisable(1)Gary Dreher,
    
    
    0
    
    
    
    0
    
    
    
    2,395,000 / 0
    
    
    $
    105,000/0President and CEOArthur S. Rosten,
    
    
    0
    
    
    
    0
    
    
    
    224,000 / 0
    
    
    $
    22,500/0Chief FinancialOfficer
 
 (1)
    
    Based on a price of $0.78 per share, the closing price as reported on the American
Stock Exchange on December 31, 2004. Director Compensation
  20




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##### Table of Contents



Employment Agreements
  Change in Control Severance Pay Plan
     Report of the Compensation Committee on Executive Compensation
 Our Compensation Committee has issued the following report:
 Compensation Philosophy.
 Base Salaries.
 Cash Bonuses.
 21




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##### Table of Contents



Stock Options.
 CEO Compensation.
 Compensation Limitations.
 William M. Thompson III, M.D.Douglas C. MacLellanEdward R. Arquilla, M.D., Ph.D.COMPENSATION COMMITTEE
 22




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##### Table of Contents



Item 11. Security Ownership of Certain Beneficial Owners and Management.
  PercentageName and Address(1)
    
    Number of Shares
    
    OwnedGary L. Dreher
    
    
    4,405,500
    (2)
    
    
    17.0
    %William M. Thompson III, M.D.
    
    
    455,191
    (3)
    
    
    1.9
    %408 Town Square LaneHuntington Beach, CA 92648Douglas C. MacLellan
    
    
    335,500
    (4)
    
    
    1.4
    %8324 Delgany AvenuePlaya del Rey, CA 90293Edward R. Arquilla, M.D., Ph.D.
    
    
    344,820
    (5)
    
    
    1.5
    %Department of PathologyUniversity of California  IrvineIrvine, CA 92697Marvin E. Rosenthale, Ph.D.
    
    
    225,000
    (6)
    
    
    *6908 Queenferry CircleBoca Raton, FL 33496Arthur S. Rosten
    
    
    224,000
    (7)
    
    
    *Chinese Universal Technologies Co., Ltd.
    
    
    2,000,000
    (8)
    
    
    8.5
    %7F-3B1, 61 SEC GUN GYI Road403 Taichuna, TaiwanBoston Financial Partners, Inc.
    
    
    1,323,095
    (9)
    
    
    5.4
    %601 Edgewater Drive. Suite 195Wakefield, Massachusetts 01880All Directors and Officers
    
    
    5,990,011
    
    
    
    21.8
    %as a group (6 persons)
 
 *
    
    Less than 1.0%(1)
    
    Unless otherwise indicated, address is 2492 Walnut Avenue, Suite 100, Tustin, California,
92780.(2)
    
    Includes 350,000 shares of common stock issuable upon the exercise of options at $0.48 per
share, 300,000 shares of common stock issuable upon the exercise of options at $0.83 per
share, 250,000 shares of common stock issuable upon the exercise of options at $0.93 per
share, 100,000 shares of common stock issuable upon the exercise of options at $1.00 per
share, 245,000 shares of common stock issuable upon the exercise of options at $1.10 per
share, 700,000 shares of common stock issuable upon the exercise of options at $1.23 per
share, 100,000 shares of common stock issuable upon the exercise of options at $2.25 per
share, and 350,000 shares of common stock issuable upon the exercise of options at $4.00 per
share. Also includes 2,000,000 shares of common stock for which Mr. Dreher serves as a voting
co-trustee (see footnote (8) below) of which he disclaims beneficial ownership.(3)
    
    Includes, 65,000 shares of common stock issuable upon the exercise of options at $0.48 per
share, 55,000 shares of common stock issuable upon the exercise of options at $0.93 per share,
20,000 shares of common stock issuable upon the exercise of options at $1.00 per share, 40,000 shares of common
stock issuable upon 23




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the exercise of options at $1.10 per share, 200,000 shares of common
stock issuable upon the exercise of options at $1.23 per share, 20,000 shares of
common stock issuable upon the exercise of options at $2.25 per share, and 35,000 shares of
common stock issuable upon the exercise of options at $4.00 per share.(4)
    
    Includes, 65,000 shares of common stock issuable upon the exercise of options at $0.48 per
share, 55,000 shares of common stock issuable upon the exercise of options at $0.93 per share,
20,000 shares of common stock issuable upon the exercise of options at $1.00 per share, 40,000
shares of common stock issuable upon the exercise of options at $1.10 per share, 200,000
shares of common stock issuable upon the exercise of options at $1.23 per share,
20,000 shares of common stock issuable upon the exercise of options at $2.25 per share,
and 35,000 shares of common stock issuable upon the exercise of options at $4.00 per share.(5)
    
    Includes, 65,000 shares of common stock issuable upon the exercise of options at $0.48 per
share, 55,000 shares of common stock issuable upon the exercise of options at $0.93 per share,
20,000 shares of common stock issuable upon the exercise of options at $1.00 per share, 40,000
shares of common stock issuable upon the exercise of options at $1.10 per share, 200,000
shares of common stock issuable upon the exercise of options at $1.23 per share,
20,000 shares of common stock issuable upon the exercise of options at $2.25 per share,
and 35,000 shares of common stock issuable upon the exercise of options at $4.00 per share.(6)
    
    Includes 35,000 shares of common stock issuable upon the exercise of options at $0.48 per
share, 55,000 shares of common stock issuable upon the exercise of options at $0.93 per share,
40,000 shares of common stock issuable upon the exercise of options at $1.10, per share,
100,000 shares of common stock issuable upon the exercise of options at $1.23 per share, and
50,000 shares of common stock issuable upon the exercise of options at an exercise price of
$2.39 per share.(7)
    
    Includes 75,000 shares of common stock issuable upon the exercise of options at $0.48 per
share, 5,000 shares of common stock issuable upon the exercise of options at $0.97 per share,
70,000 shares of common stock issuable upon the exercise of options at $1.10 per share, 70,000
shares of common stock issuable upon the exercise of options at $1.23 per share, and 4,000
shares of common stock issuable upon the exercise of options at $2.25 per share.(8)
    
    The Company believes that one or more individuals may be deemed to share beneficial ownership
in these shares due to their control of Chinese Universal Technologies Co., Ltd. The Company
is unable to ascertain who those individuals or entities might be. These same 2,000,000
shares of common stock are subject to a Voting Trust Agreement dated as of December 14, 2000
pursuant to which Dr. Fong-Lin Huang and Gary L. Dreher serve as voting co-trustees. The
Voting Trust Agreement provides that during its 10 year term, (i) the voting trustees shall
not be required to elect to cumulatively vote the shares subject to the voting trust, (ii) Mr.
Dreher or his successor shall always, in any election of directors, vote in favor of one
nominee of Chinese Universal Technologies Co., Ltd., and (iii) on all other matters coming
before the stockholders, the voting trustees shall be required to vote unanimously in favor
(or opposed or in abstention) with regard to all such matters, otherwise such vote shall not
be counted as having been voted on a proposal, except that the vote or proxy of only one
trustee shall be required to count the shares as present for purposes of establishing a
quorum.(9)
    
    According to a Schedule 13G filed on January 5, 2005 which includes 946,875 shares of common
stock issuable upon exercise of warrants. (Note: this was incorrectly reported as 5.8% on the
Schedule 13G). 
 Item 12. Certain Relationships and Related Transactions.
 ® ®
 24




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##### Table of Contents



Item 13. Exhibits.
 Exhibit No.3.1
    
    Certificate of Incorporation of the Company(1)3.2
    
    Bylaws of the Company(2)3.3
    
    Certificate of Amendment(3)4.1
    
    Specimen of Common Stock Certificate(4)4.2
    
    Certificate of Designations(4)9.1
    
    Voting Trust Agreement by and between Jeanne Lai and Gary L. Dreher, as Co-Trustees, and
Chinese Universal Technologies Co., Ltd.(5)10.1
    
    Amendments to License Agreement between the Company and AMDL Canada, Inc., dated September
20, 1989, June 16, 1990 and July 5, 1990(6)10.2
    
    The Companys 1992 Stock Option Plan(2)10.3
    
    Operating Agreement of ICD, L.L.C.(7)10.4
    
    Letter Agreement between the Company and BrianaBio-Tech, Inc. and AMDL Canada, Inc., dated
February 7, 1995(7)10.5
    
    The Companys Stock Bonus Plan(8)10.6
    
    Employment Agreement between the Company and Gary L. Dreher, dated January 15, 1998(9)10.7
    
    Salary Continuation Agreement between the Company and That T. Ngo, Ph.D., dated May 21, 1998(10)10.8
    
    Salary Continuation Agreement between the Company and Thomas V. Tilton, dated May 21, 1998(10)10.9
    
    Salary Continuation Agreement between the Company and Harry Berk, dated May 21, 1998(10)10.10
    
    Salary Continuation Agreement between the Company and Gary L. Dreher, dated May 21, 1998(10)10.11
    
    Agreement between the Company and William M. Thompson, M.D., dated May 21, 1998(10)10.12
    
    Amendment No. 1 to Employment Agreement with That T. Ngo, Ph.D., dated July 1, 1998 (10)10.13
    
    Agreement Relating to Salary deferral between the Company and Thomas V. Tilton, dated July
1, 1998(10)10.14
    
    Agreement Relating to Salary deferral between the Company and Harry Berk, dated July 1,
1998(10)10.15
    
    Securities Purchase Agreement between the Company and the Purchasers listed on the Purchaser
Signature Pages attached thereto, dated February 17, 1999(11)10.16
    
    The Companys 1999 Stock Option Plan(11)10.17
    
    Agreement Regarding Cancellation of Indebtedness between the Company and William M.
Thompson, III, M.D., dated July 1, 1999(11)10.18
    
    Agreement Regarding Cancellation of Indebtedness between the Company and Harry Berk, dated
July 1, 1999(11)
 25




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##### Table of Contents



Exhibit No.10.19
    
    Agreement Regarding Cancellation of Indebtedness between the Company and Edward Arquilla,
M.D., dated July 1, 1999(11)10.20
    
    Agreement Regarding Cancellation of Indebtedness between the Company and Thomas V. Tilton,
dated July 1, 1999(11)10.21
    
    Agreement Regarding Cancellation of Indebtedness between the Company and Donald Rounds,
dated July 1, 1999(11)10.22
    
    Agreement Regarding Cancellation of Indebtedness between the Company and That T. Ngo, Ph.D.,
dated July 1, 1999(11)10.23
    
    Agreement Regarding Cancellation of Indebtedness between the Company and Gary L. Dreher,
dated July 1, 1999(11)10.24
    
    Agreement Regarding Cancellation of Indebtedness between the Company and Douglas C.
MacLellan, dated July 1, 1999(11)10.25
    
    Employment Agreement of Gary L. Dreher dated November 23, 1999(4)10.26
    
    Consulting Agreement with That T. Ngo dated October 1, 1999(4)10.27
    
    Securities Purchase Agreement between the Company and the Purchasers listed on the Purchaser
Signature Pages attached thereto dated February 9, 2000(4)10.28
    
    Securities Purchase Agreement dated as of December 14, 2000 executed December 19, 2000(5).10.29
    
    Secured Promissory Note dated December 14, 2000, effective December 19, 2000(5)10.30
    
    Security and Pledge Agreement dated as of December 14, 2000, executed December 19, 2000(5)10.31
    
    Voting Trust Agreement dated as of December 14, 2000, executed December 19, 2000(5)10.32
    
    Exclusive Distribution Agreement dated December 14, 2000, effective December 19, 2000(5)10.33
    
    Technology Transfer Agreement effective July 30, 2001 between the Company and Lung-Ji Chang,
Ph.D.(12)10.34
    
    Executive Management Change in Control Severance Plan (13)10.35
    
    The Companys 2002 Stock Option Plan (14)10.36
    
    The Companys 2004 Stock Option Plan (15)10.37
    
    Employment Agreement of Gary L. Dreher dated January 31, 2005 (16)21.1
    
    Subsidiaries of the small business issuerNot Applicable.*31.1
    
    Rule 13a-14(a)/15d-14(a) Certification of Chief Executive Officer*31.2
    
    Rule 13a-14(a)/15d-14(a) Certification of Chief Financial Officer*32.1
    
    Certification Pursuant to 18 U.S.C. §1350 of Chief Executive Officer*32.2
    
    Certification Pursuant to 18 U.S.C. §1350 of Chief Financial Officer
 26




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##### Table of Contents



*
    
    filed herewith(1)
    
    Incorporated by reference to the Companys Report on Form 10-K for the
year ended December 31, 1989.(2)
    
    Incorporated by reference to the Companys Report on Form 10-K for the
year ended December 31, 1991.(3)
    
    Incorporated by reference to the Companys Report on Form 10-QSB for the
period ended September 30, 1998.(4)
    
    Incorporated by reference to the Companys Report on Form 10-KSB for the
year ended December 31, 1999.(5)
    
    Incorporated by reference to the Companys Report on Form 8-K dated
December 26, 2000.(6)
    
    Incorporated by reference to the Companys Report on Form 10-K for the
year ended December 31, 1990.(7)
    
    Incorporated by reference to the Companys Report on Form 10-KSB for the
year ended December 31, 1993.(8)
    
    Incorporated by reference to the Companys Report on Form 10-KSB for the
year ended December 31, 1995.(9)
    
    Incorporated by reference to the Companys Report on Form 10-KSB for the
year ended December 31, 1997.(10)
    
    Incorporated by reference to the Companys Report on Form 10-QSB for the
period ended June 30, 1998.(11)
    
    Incorporated by reference to the Companys Registration Statement on Form
10-SB dated October 15, 1999.(12)
    
    Incorporated by reference from the Companys Report on Form 8-K dated
August 31, 2001(13)
    
    Incorporated by reference from the Companys Report on Form 10-KSB for
the year ended December 31, 2001.(14)
    
    Incorporated by reference from the Companys Report on Form 10-KSB for
the year ended December 31, 2002.(15)
    
    Incorporated by reference from the Companys Report on Form 10-KSB for
the year ended December 31, 2004.(16)
    
    Incorporated by reference from the Companys Form 8-K filed February 1,
2005. 
 Item 14. Principal Accountant Fees and Services
  Audit and Non-Audit Fees
  27




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##### Table of Contents



Services Provided
    
    2004
    
    
    2003Audit Fees
    
    $
    38,000
    
    
    $
    43,000Audit Related Fees
    
    $
    
    
    
    $
    Tax Fees
    
    $
    
    
    
    $
    All Other Fees
    
    $
    18,050
    
    
    $
    50,605Total
    
    $
    56,050
    
    
    $
    93,605
     Audit Committee Pre-Approval Policies and Procedures
  28




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##### Table of Contents



SIGNATURES
  AMDL, INC.Dated: November 10, 2005
    
    By
    
    /s/ Gary L DreherGary L. DreherPresident and Chief Executive OfficerDated: November 10, 2005
    
    By:
    
    /s/ Arthur S. RostenArthur S. Rosten,Chief Financial Officer
  Signatures
    
    Title
    
    Date/s/ Gary L. Dreher
    
    President and Chief Executive Officer
    
    November 10, 2005Gary L. Dreher
    
    and Director (principal executive officer)/s/ Arthur S. Rosten
    
    Chief Financial Officer (principal
    
    November 10, 2005Arthur S. Rosten
    
    financial and accounting officer)/s/ William M. Thompson
    
    Chairman of the Board
    
    November 10, 2005William M. Thompson III, M.D./s/ Edward R. Arquilla
    
    Director
    
    November 10, 2005Edward R. Arquilla, M.D./s/ Douglas C. MacLellan
    
    Director
    
    November 10, 2005Douglas C. MacLellan/s/ Marvin E. Rosenthale
    
    Director
    
    November 10, 2005Marvin E. Rosenthale
 29




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##### Table of Contents



EXHIBIT
INDEX
 Exhibit No.
    

Description3.1
    
    Certificate of Incorporation of the Company(1)3.2
    
    Bylaws of the Company(2)3.3
    
    Certificate of Amendment(3)4.1
    
    Specimen of Common Stock Certificate(4)4.2
    
    Certificate of Designations(4)9.1
    
    Voting Trust Agreement by and between Jeanne Lai and Gary L. Dreher, as Co-Trustees, and
Chinese Universal Technologies Co., Ltd.(5)10.1
    
    Amendments to License Agreement between the Company and AMDL Canada, Inc., dated September
20, 1989, June 16, 1990 and July 5, 1990(6)10.2
    
    The Companys 1992 Stock Option Plan(2)10.3
    
    Operating Agreement of ICD, L.L.C.(7)10.4
    
    Letter Agreement between the Company and BrianaBio-Tech, Inc. and AMDL Canada, Inc., dated
February 7, 1995(7)10.5
    
    The Companys Stock Bonus Plan(8)10.6
    
    Employment Agreement between the Company and Gary L. Dreher, dated January 15, 1998(9)10.7
    
    Salary Continuation Agreement between the Company and That T. Ngo, Ph.D., dated May 21, 1998(10)10.8
    
    Salary Continuation Agreement between the Company and Thomas V. Tilton, dated May 21, 1998(10)10.9
    
    Salary Continuation Agreement between the Company and Harry Berk, dated May 21, 1998(10)10.10
    
    Salary Continuation Agreement between the Company and Gary L. Dreher, dated May 21, 1998(10)10.11
    
    Agreement between the Company and William M. Thompson, M.D., dated May 21, 1998(10)10.12
    
    Amendment No. 1 to Employment Agreement with That T. Ngo, Ph.D., dated July 1, 1998 (10)10.13
    
    Agreement Relating to Salary deferral between the Company and Thomas V. Tilton, dated July
1, 1998(10)10.14
    
    Agreement Relating to Salary deferral between the Company and Harry Berk, dated July 1,
1998(10)10.15
    
    Securities Purchase Agreement between the Company and the Purchasers listed on the Purchaser
Signature Pages attached thereto, dated February 17, 1999(11)10.16
    
    The Companys 1999 Stock Option Plan(11)10.17
    
    Agreement Regarding Cancellation of Indebtedness between the Company and William M.
Thompson, III, M.D., dated July 1, 1999(11)10.18
    
    Agreement Regarding Cancellation of Indebtedness between the Company and Harry Berk, dated
July 1, 1999(11)
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##### Table of Contents



Exhibit No.
    

Description10.19
    
    Agreement Regarding Cancellation of Indebtedness between the Company and Edward Arquilla,
M.D., dated July 1, 1999(11)10.20
    
    Agreement Regarding Cancellation of Indebtedness between the Company and Thomas V. Tilton,
dated July 1, 1999(11)10.21
    
    Agreement Regarding Cancellation of Indebtedness between the Company and Donald Rounds,
dated July 1, 1999(11)10.22
    
    Agreement Regarding Cancellation of Indebtedness between the Company and That T. Ngo, Ph.D.,
dated July 1, 1999(11)10.23
    
    Agreement Regarding Cancellation of Indebtedness between the Company and Gary L. Dreher,
dated July 1, 1999(11)10.24
    
    Agreement Regarding Cancellation of Indebtedness between the Company and Douglas C.
MacLellan, dated July 1, 1999(11)10.25
    
    Employment Agreement of Gary L. Dreher dated November 23, 1999(4)10.26
    
    Consulting Agreement with That T. Ngo dated October 1, 1999(4)10.27
    
    Securities Purchase Agreement between the Company and the Purchasers listed on the Purchaser
Signature Pages attached thereto dated February 9, 2000(4)10.28
    
    Securities Purchase Agreement dated as of December 14, 2000 executed December 19, 2000(5).10.29
    
    Secured Promissory Note dated December 14, 2000, effective December 19, 2000(5)10.30
    
    Security and Pledge Agreement dated as of December 14, 2000, executed December 19, 2000(5)10.31
    
    Voting Trust Agreement dated as of December 14, 2000, executed December 19, 2000(5)10.32
    
    Exclusive Distribution Agreement dated December 14, 2000, effective December 19, 2000(5)10.33
    
    Technology Transfer Agreement effective July 30, 2001 between the Company and Lung-Ji Chang,
Ph.D.(12)10.34
    
    Executive Management Change in Control Severance Plan (13)10.35
    
    The Companys 2002 Stock Option Plan (14)10.36
    
    The Companys 2004 Stock Option Plan (15)10.37
    
    Employment Agreement of Gary L. Dreher dated January 31, 2005 (16)21.1
    
    Subsidiaries of the small business issuerNot Applicable.*31.1
    
    Rule 13a-14(a)/15d-14(a) Certification of Chief Executive Officer*31.2
    
    Rule 13a-14(a)/15d-14(a) Certification of Chief Financial Officer*32.1
    
    Certification Pursuant to 18 U.S.C. §1350 of Chief Executive Officer*32.2
    
    Certification Pursuant to 18 U.S.C. §1350 of Chief Financial Officer
 31




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##### Table of Contents



*
    
    filed herewith(1)
    
    Incorporated by reference to the Companys Report on Form 10-K for the
year ended December 31, 1989.(2)
    
    Incorporated by reference to the Companys Report on Form 10-K for the
year ended December 31, 1991.(3)
    
    Incorporated by reference to the Companys Report on Form 10-QSB for the
period ended September 30, 1998.(4)
    
    Incorporated by reference to the Companys Report on Form 10-KSB for the
year ended December 31, 1999.(5)
    
    Incorporated by reference to the Companys Report on Form 8-K dated
December 26, 2000.(6)
    
    Incorporated by reference to the Companys Report on Form 10-K for the
year ended December 31, 1990.(7)
    
    Incorporated by reference to the Companys Report on Form 10-KSB for the
year ended December 31, 1993.(8)
    
    Incorporated by reference to the Companys Report on Form 10-KSB for the
year ended December 31, 1995.(9)
    
    Incorporated by reference to the Companys Report on Form 10-KSB for the
year ended December 31, 1997.(10)
    
    Incorporated by reference to the Companys Report on Form 10-QSB for the
period ended June 30, 1998.(11)
    
    Incorporated by reference to the Companys Registration Statement on Form
10-SB dated October 15, 1999.(12)
    
    Incorporated by reference from the Companys Report on Form 8-K dated
August 31, 2001(13)
    
    Incorporated by reference from the Companys Report on Form 10-KSB for
the year ended December 31, 2001.(14)
    
    Incorporated by reference from the Companys Report on Form 10-KSB for
the year ended December 31, 2002.(15)
    
    Incorporated by reference from the Companys Report on Form 10-KSB for
the year ended December 31, 2004.(16)
    
    Incorporated by reference from the Companys Form 8-K filed February 1,
2005. 32