----

----

----

----

|  x  | Annual      Report Pursuant to Section 13 or 15(d) of the Securities Exchange Act of      1934     |
|----------|----------------------------------------------------------------------------------------------------|
|     | For      the fiscal year ended December 31,      2008                                              |
|     |                                                                                               |
|  OR |
|     |                                                                                               |
|  o  | Transition      Report Pursuant to Section 13 or 15(d) of the Securities Exchange Act of      1934 |

| DELAWARE                                                            |   | 13-3301899                                      |
|---------------------------------------------------------------------|--------|-------------------------------------------------|
| (State      or Other Jurisdiction of Incorporation or Organization) |   |  (I.R.S.      Employer Identification No.) |
|                                                                |   |                                            |
| 8777 E. Via de Ventura, Suite 280, Scottsdale,      AZ              |   |  85258                                     |
|  (Address      of Principal Executive Offices)                 |   |  (Zip      Code)                           |

----

| Name                               |   | Age |   | Position                                             |
|------------------------------------|--------|-----|--------|------------------------------------------------------|
| Michael      K. Wilhelm            |   | 42  |   | President,      Chief Executive Officer and Director |
| John      N. Fermanis              |   | 55  |   | Chief      Financial Officer                         |
| Hal      N. Siegel, Ph.D.          |   | 54  |   | Chief      Scientific Officer and Director           |
| Lance      K. Gordon, Ph.D.        |   | 61  |   | Director                                             |
| Robert      J. Hariri, M.D., Ph.D. |   | 50  |   | Director                                             |
| Theodore      E. Staahl, M.D.      |   | 64  |   | Director                                             |
| Jerome      B. Zeldis, M.D., Ph.D. |   | 59  |   | Director                                             |

----

----

| ·   | Mr.      Wilhelm failed to file 22 Form 4s for 40 transactions that occurred in      2004, 2005, 2006, 2007 and 2008.  Mr. Wilhelm failed to file a      Form 5 for fiscal 2003, 2004, 2005, 2006 and 2007.  Mr. Wilhelm      filed a Form 5 for fiscal 2008 on February 18, 2009 which reported 40 of      these transactions.  Mr. Wilhelm’s Form 5 for fiscal 2008 was      not timely filed; |
|--------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|

| ·   | Mr.      Fermanis failed to file 6 Form 4s for 7 transactions that occurred in      2004, 2005, 2006 and 2007.  Mr. Fermanis failed to file a Form 5      for fiscal 2004, 2005, 2006 and 2007.  Mr. Fermanis filed a Form      5 for fiscal 2008 on February 17, 2009 which reported 7 of these      transactions; |
|--------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|

| ·   | Dr.      Siegel failed to file 5 Form 4s for 5 transactions that occurred in      2005.  Dr. Siegel failed to file a Form 5 for fiscal 2006 and      2007.  Dr. Siegel filed a Form 5 for fiscal 2008 on February 17,      2009 which reported 5 of thesetransactions; |
|--------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|

| ·   | Dr.      Gordon failed to file a Form 4 for 1 transaction that occurred in 2007 to      report an option grant he received in August 2007 and failed to file a      Form 5 for fiscal 2007.  Dr. Gordon filed a Form 5 for fiscal      2008 on February 17, 2009 which reported 1  transaction; |
|--------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|

| ·   | Dr.      Hariri failed to file a Form 4 for 2 transactions that occurred in 2007 to      report option grants he received in August 2007 and failed to file a Form      5 for fiscal 2007 and 2008; |
|--------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|

| ·   | Dr.      Staahl failed to file 11 Form 4s for 14 transactions that occurred in      2003, 2004, 2006, 2007 and 2008.  Dr. Staahl failed to file a      Form 5 for fiscal 2003, 2004, 2005, 2006 and 2007. Dr. Staahl filed a Form      5 for fiscal 2008 on February 17, 2009 which reported 14 of these      transactions; and, |
|--------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|

| ·   | Dr.      Zeldis failed to timely file a Form 3 within 10 days of his appointment as      a director in 2007 and failed to file 2 Form 4s for 2 transactions that      occurred in 2008 and failed to file a Form 5 for fiscal      2007.  Dr. Zeldis filed a Form 5 for fiscal 2008 on February 17,      2009 which reported 2 of thesetransactions. |
|--------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|

----

| Name      and Principal Position  |   | Fiscal      Year |   | Salary($) |    |   | Bonus($) |    |    | StockAwards($) |   |   | OptionAwards($)(1) |   |   | All      OtherCompensation($)(2) |    |   | Total($) |   |
|-----------------------------------|--------|------------------|--------|-----------|---------|--------|----------|---------|---------|----------------|--------|--------|--------------------|--------|--------|----------------------------------|---------|--------|----------|--------|
| Michael      K. Wilhelm           |   |             |   |      |    |   |     |    |    |           |   |   |               |   |   |                             |    |   |     |   |
| President,      CEO and           |   | 2008             |   | $         | 344,842 |   |     | $       | 550,000 | (3)            |   | $      | —            |   |   | $                                | — |   |     | $      | 15,820 |   |   | $ | 910,662 |   |
| Director                          |   | 2007             |   | $         | 315,414 |   |     | $       | 82,239  | (3)            |   | $      | —            |   |   | $                                | 883,544 |   |     | $      | 15,820 |   |   | $ | 1,297,017 |   |
|                              |   |             |   |      |    |   |     |    |    |           |   |   |               |   |   |                             |    |   |     |   |   |   |   |   |   |   |
| John      N. Fermanis             |   | 2008             |   | $         | 130,000 |   |     | $  | 7,800   |           |   | $      | —            |   |   | $                                | — |   |     | $      | 6,498 |   |   | $ | 144,298 |   |
| Chief      Financial Officer      |   | 2007             |   | $         | 112,000 |   |     | $       | 5,800   |           |   | $      | —            |   |   | $                                | 230,051 |   |     | $      | 5,994 |   |   | $ | 353,845 |   |
|                              |   |             |   |      |    |   |     |    |    |           |   |   |               |   |   |                             |    |   |     |   |   |   |   |   |   |   |
| Hal      N. Siegel                |   |             |   |      |    |   |     |    |    |           |   |   |               |   |   |                             |    |   |     |   |   |   |   |   |   |   |
| Vice-President                    |   | 2008             |   | $         | 210,000 |   |     | $       | 10,000  |           |   | $      | —            |   |   | $                           | — |   |     | $      | — |   |   | $ | 220,000 |   |
| and      Chief Scientific Officer |   | 2007             |   | $         | 201,884 |   |     | $       | — |           |   | $      | —            |   |   | $                                | 263,147 |   |     | $      | — |   |   | $ | 465,031 |   |

| (1)   | The amounts shown in this      column represent the dollar amounts recognized for share-based      compensation expense for financial statement reporting purposes for      unvested stock options granted in prior years in accordance with Statement      of Financial Accounting Standards No. 123 (revised 2004), Share-Based Payment, or      SFAS 123(R), but without giving effect to estimated forfeitures      related to service-based vesting conditions. The assumptions used to      compute the fair value are disclosed in “Note 7, Stock Options and      Warrants”, a footnote to our audited financial statements for the fiscal      year ended December 31,2008. |
|-----------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|

| Named      Executive Officer |   | Grant      Date         |   | Price      ($) |   |   | Underlying      Options |   |    | Compensation      Cost |   |
|------------------------------|--------|-------------------------|--------|----------------|--------|--------|-------------------------|--------|---------|------------------------|--------|
| Michael      K. Wilhelm      |   | August      1, 2007     |   | $              | 1.66   |   |                    |   | 200,000 |                   |   | $ | 330,975 |   |
|                         |   | August      1, 2007     |   | $              | 1.95   |   |                    |   | 50,000  |                   |   | $ | 81,112 |   |
|                         |   | September      13, 2006 |   | $              | 2.20   |   |                    |   | 350,000 |                   |   | $ | 329,073 |   |
|                         |   | July      14, 2006      |   | $              | 2.31   |   |                    |   | 189,697 |                   |   | $ | 142,384 |   |
|                         |   |                    |   |           |   |   |                    |   |    |                   |   | $ | 883,544 |   |
|                         |   |                    |   |           |   |   |                    |   |    |                   |   |   |   |   |
| John      N. Fermanis        |   | August      1, 2007     |   | $              | 1.66   |   |                    |   | 90,000  |                   |   | $ | 148,939 |   |
|                         |   | August      1, 2007     |   | $              | 1.95   |   |                    |   | 50,000  |                   |   | $ | 81,112 |   |
|                         |   |                    |   |           |   |   |                    |   |    |                   |   | $ | 230,051 |   |
|                         |   |                    |   |           |   |   |                    |   |    |                   |   |   |   |   |
| Hal      N. Siegel           |   | August      1, 2007     |   | $              | 1.66   |   |                    |   | 110,000 |                   |   | $ | 182,035 |   |
|                         |   | August      1, 2007     |   | $              | 1.95   |   |                    |   | 50,000  |                   |   | $ | 81,112 |   |
|                         |   |                    |   |           |   |   |                    |   |    |                   |   | $ | 263,147 |   |

| (2)   | Other      compensation includes automobile lease agreements paid on behalf of the      executive officers.  |
|-----------------|-------------------------------------------------------------------------------------------------------------------|

| (3)   | Target      incentive bonus paid to Michael K. Wilhelm, our President and Chief      Executive Officer, per the terms of his employment agreement dated August      10, 2005, as amended November 7,2005. |
|-----------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|

----

| Named Executive      Officer  |   | Bonus      Date  |   | Bonus      ($) |    | Form      of Bonus |
|------------------------------------|--------|-----------------------|--------|----------------|---------|--------------------|
| Michael      K. Wilhelm            |   | January      7, 2007  |   | $              | 82,293  |               | Cash |
|                               |   |                  |   | $              | 82,293  |               |   |
|                               |   |                  |   |           |    |               |   |
| Michael      K. Wilhelm            |   | January      9, 2008  |   | $              | 90,750  |               | Cash |
| Michael      K. Wilhelm            |   | July      3, 2008     |   | $              | 59,250  |               | Cash |
| Michael      K. Wilhelm            |   | August      15, 2008  |   | $              | 150,000 |               | Cash |
| Michael      K. Wilhelm            |   | August      15, 2008  |   | $              | 250,000 |               | Restricted      Common Stock |
|                               |   |                  |   | $              | 550,000 |               |   |

|                                    |   | Option      Awards |    |   | Stock    Awards |   |
|-----------------------------------------|--------|--------------------|---------|--------|-----------------|--------|
|                                    |   |               |    |   |            |   |   | Equity |   |   |   |   |   |   |   |   |   |   |   |   |   |
|                                    |   |               |    |   |            |   |   | Incentive |   |   |   |   |   |   |   |   |   |   |   |   |   |
|                                    |   |               |    |   |            |   |   | Plan |   |   |   |   |   |   |   |   |   |   |   |   |   |
|                                    |   |               |    |   |            |   |   | Awards: |   |   |   |   |   |   |   |   |   |   |   | Market |   |
|                                    |   | Number      of     |    |   | Number      of  |   |   | Number      of |   |   |   |   |   |   |   |   |   |   |   | Value      of |   |
|                                    |   | Securities         |    |   | Securities      |   |   | Securities |   |   |   |   |   |   |   |   | Number      of |   |   | Shares      or |   |
|                                    |   | Underlying         |    |   | Underlying      |   |   | Underlying |   |   |   |   |   |   |   |   | Shares      or |   |   | Units      of |   |
|                                    |   | Unexercised        |    |   | Unexercised     |   |   | Unexercised |   |   |   |   |   |   |   |   | Units      of |   |   | Stock      That |   |
|                                    |   | Options            |    |   | Options         |   |   | Unearned |   |   | Option |   |   | Option |   |   | Stock      That |   |   | Have      Not |   |
|                                    |   | (#)                |    |   | (#)             |   |   | Options |   |   | Exercised |   |   | Expiration |   |   | Have      Not |   |   | Vested |   |
| Name                                    |   | Exercisable        |    |   | Unexercisable   |   |   | (#) |   |   | Price ($) |   |   | Date |   |   | Vested (#) |   |   |  ($) |   |
|                                    |   |               |    |   |            |   |   |   |   |   |   |   |   |   |   |   |   |   |   |   |   |   |   |   |   |   |   |   |
| Michael      K. Wilhelm,                |   |               | 15,000  |   |            |   | — |   |   |   | — |   |   | $ | 4.40 |   |   |   | 5/19/10 |   |   |   | — |   |   |   | — |   |
| President,      Chief Executive Officer |   |               | 10,303  |   |            |   | — |   |   |   | — |   |   | $ | 3.30 |   |   |   | 8/9/10 |   |   |   | — |   |   |   | — |   |
|                                    |   |               | 189,697 |   |            |   | — |   |   |   | — |   |   | $ | 2.31 |   |   |   | 7/13/11 |   |   |   | — |   |   |   | — |   |
|                                    |   |               | 45,455  |   |            |   | — |   |   |   | — |   |   | $ | 2.20 |   |   |   | 9/12/11 |   |   |   | — |   |   |   | — |   |
|                                    |   |               | 304,546 |   |            |   | — |   |   |   | — |   |   | $ | 2.20 |   |   |   | 9/12/11 |   |   |   | — |   |   |   | — |   |
|                                    |   |               | 200,000 |   |            |   | — |   |   |   | — |   |   | $ | 1.66 |   |   |   | 7/31/17 |   |   |   | — |   |   |   | — |   |
|                                    |   |               | 50,000  |   |            |   | — |   |   |   | — |   |   | $ | 1.95 |   |   |   | 7/31/17 |   |   |   | — |   |   |   | — |   |
|                                    |   |               |    |   |            |   |   |   |   |   |   |   |   |   |   |   |   |   |   |   |   |   |   |   |   |   |   |   |
| John      N. Fermanis,                  |   |               | 90,000  |   |            |   | — |   |   |   | — |   |   | $ | 1.66 |   |   |   | 7/31/17 |   |   |   | — |   |   |   | — |   |
| Chief      Financial Officer            |   |               | 50,000  |   |            |   | — |   |   |   | — |   |   | $ | 1.95 |   |   |   | 7/31/17 |   |   |   | — |   |   |   | — |   |
|                                    |   |               |    |   |            |   |   |   |   |   |   |   |   |   |   |   |   |   |   |   |   |   |   |   |   |   |   |   |
|                                    |   |               |    |   |            |   |   |   |   |   |   |   |   |   |   |   |   |   |   |   |   |   |   |   |   |   |   |   |
| Hal      N. Siegel, Ph.D.,              |   |               | 20,000  |   |            |   | — |   |   |   | — |   |   | $ | 2.00 |   |   |   | 10/22/11 |   |   |   | — |   |   |   | — |   |
| Vice      President and                 |   |               | 110,000 |   |            |   | — |   |   |   | — |   |   | $ | 1.66 |   |   |   | 7/31/17 |   |   |   | — |   |   |   | — |   |
| Chief      Scientific Officer           |   |               | 50,000  |   |            |   | — |   |   |   | — |   |   | $ | 1.95 |   |   |   | 7/31/17 |   |   |   | — |   |   |   | — |   |

Grants in Fiscal Years2008

----

----

|                                                            |   |                     |      |   |                     |   |   | (c)                             |   |
|-----------------------------------------------------------------|--------|--------------------------|-----------|--------|--------------------------|--------|--------|---------------------------------|--------|
|                                                            |   | (a)                      |      |   |                     |   |   | Number      of securities       |   |
|                                                            |   | Number                   |      |   |                     |   |   | remaining      available for    |   |
|                                                            |   | of      securities to be |      |   | (b)                      |   |   | future      issuance under      |   |
|                                                            |   | issued                   |      |   | Weighted-average         |   |   | equity      compensation        |   |
|                                                            |   | upon      exercise of    |      |   | exercise      price of   |   |   | plans      excluding securities |   |
| Plan      Category                                              |   | outstanding      options |      |   | Outstanding      options |   |   | reflected in      column(a)     |   |
| Equity      Compensation Plans Approved by Stockholders (1)     |   |                     | 1,784,847 |   |                     | $      | 2.65   |                            |   |   | 3,857,503 |   |
| Equity      Compensation Plans Not Approved by Stockholders (2) |   |                     | 6,322     |   |                     | $      | 250.00 |                            |   |   | n/a |   |

----

|                               |   | Fees         |    |   |      |   |    |      |   |   |                |   |   |         |    |   |           |   |    |   |   |
|------------------------------------|--------|--------------|---------|--------|-----------|--------|---------|-----------|--------|--------|---------------------|--------|--------|--------------|---------|--------|----------------|--------|---------|--------|--------|
|                               |   | Earned       |    |   |      |   |    |      |   |   |                |   |   |         |    |   |           |   |    |   |   |
|                               |   | or           |    |   |      |   |    |      |   |   | Non-Equity          |   |   | Nonqualified |    |   |           |   |    |   |   |
|                               |   | Paid      in |    |   | Stock     |   |    | Option    |   |   | Incentive      Plan |   |   | Deferred     |    |   | All      Other |   |    |   |   |
|                               |   | Cash         |    |   | Awards    |   |    | Awards    |   |   | Compensation        |   |   | Compensation |    |   | Compensation   |   |    | Total  |   |
| Name                               |   | ($)          |    |   | ($)(1)(3) |   |    | ($)(2)(3) |   |   | ($)                 |   |   | Earnings($)  |    |   | ($)            |   |    | ($)    |   |
|                               |   |         |    |   |      |   |    |      |   |   |                |   |   |         |    |   |           |   |    |   |   |   |   |   |   |   |   |   |
| Lance      K. Gordon, Ph.D.        |   |         | — |   |      |   | — |      |   |   | —             |   |   |         | — |   |           |   | — |   |   |   | — |   |   |   | — |   |
|                               |   |         |    |   |      |   |    |      |   |   |                |   |   |         |    |   |           |   |    |   |   |   |   |   |   |   |   |   |
| Robert      J. Hariri, M.D., Ph.D. |   |         | — |   |      |   | — |      |   |   | —             |   |   |         | — |   |           |   | — |   |   |   | — |   |   |   | — |   |
|                               |   |         |    |   |      |   |    |      |   |   |                |   |   |         |    |   |           |   |    |   |   |   |   |   |   |   |   |   |
| Theodore      E. Staahl, M.D.      |   |         | — |   |      |   | — |      |   |   | 26,142              |   |   |         | — |   |           |   | — |   |   |   | — |   |   |   | 26,142 |   |
|                               |   |         |    |   |      |   |    |      |   |   |                |   |   |         |    |   |           |   |    |   |   |   |   |   |   |   |   |   |
| Jerome      B. Zeldis, M.D., Ph.D. |   |         | — |   |      |   | — |      |   |   | 45,767              |   |   |         | — |   |           |   | — |   |   |   | — |   |   |   | 45,767 |   |

| (1)    |   | The      amounts shown in this column represent the dollar amounts recognized for      share-based compensation expense for financial statement reporting      purposes for unvested restricted stock granted in prior years in      accordance with Statement of Financial Accounting Standards No. 123      (revised 2004), Share-Based Payment, or      SFAS 123(R), but without giving effect to estimated forfeitures      related to service-based vesting conditions. The assumptions used to      compute the fair value are disclosed in “Note 7, Stock Options and      Warrants”, a footnote to our audited financial statements for the fiscal      year ended December 31, 2008.                                                                                                                                                                                                                                                                                                                                                       |
|--------|--------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
|   |   |                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                |
| (2)    |   | The      amounts shown in this column represent the dollar amounts recognized for      share-based compensation expense for financial statement reporting      purposes for stock options granted in 2008 and unvested stock options      granted in prior years in accordance with Statement of Financial      Accounting Standards No. 123 (revised 2004), Share-Based Payment, or      SFAS 123(R), but without giving effect to estimated forfeitures      related to service-based vesting conditions. The assumptions used to      compute the fair value are disclosed in “Note 7, Stock Options and      Warrants”, a footnote to our audited financial statements for the fiscal      year ended December 31, 2008. In 2008, Drs. Staahl and Zeldis      each were granted stock options to purchase 75,000 shares of Common      Stock with a grant date fair value of $26,142, and Dr. Zeldis was      granted stock options to purchase 25,000 shares of Common Stock with      a grant date fair value of $19,625. |
|   |   |                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                |
| (3)    |   | The      following table sets forth the aggregate number of shares of Common Stock      underlying equity awards outstanding at December 31,      2008:                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                        |

|                               |   | Stock      Option |    |
|------------------------------------|--------|-------------------|---------|
| Name                               |   | Grants            |    |
|                               |   |              |    |   |
| Lance      K. Gordon, Ph.D.        |   |              | 100,000 |   |
| Robert      J. Hariri, M.D., Ph.D. |   |              | 200,000 |   |
| Theodore      E. Staahl, M.D.      |   |              | 100,000 |   |
| Jerome      B. Zeldis, M.D., Ph.D. |   |              | 100,000 |   |

| •  | each      person or group of affiliated persons known to be the beneficial owner of      more than 5% of the Company’s Common Stock and not otherwise represented      on the Board of Directors (with respect to such stockholders, information      is presented as of December 31, 2008); |
|---------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
|          |                                                                                                                                                                                                                                                                                                    |
| •  | each      of the directors and nominees;                                                                                                                                                                                                                                                                |
|          |                                                                                                                                                                                                                                                                                                    |
| •  | each      of the Named Executive Officers; and                                                                                                                                                                                                                                                     |
|          |                                                                                                                                                                                                                                                                                                    |
| •  | all      directors and executive officers as agroup.                                                                                                                                                                                                                                                    |

----

| Beneficially      Owned                                                      |   | Shares    Held |      |   | Owned  |   |
|------------------------------------------------------------------------------|--------|----------------|-----------|--------|--------|--------|
|                                                                         |   |           |      |   |   |   |   |   |
| 5% or greater      stockholders:                                             |   |           |      |   |   |   |   |   |
| YA      Global Investments, L.P. (1)                                         |   |           | 1,450,218 |   |   |   | 9.99 | % |
| Brencourt      Advisors, LLC (2)                                             |   |           | 1,418,627 |   |   |   | 9.98 |   |
|                                                                         |   |           |      |   |   |   |   |   |
|                                                                         |   |           |      |   |   |   |   |   |
| Named Executive Officers and      Directors:                                 |   |           |      |   |   |   |   |   |
| Michael      K. Wilhelm (3)                                                  |   |           | 1,997,843 |   |   |   | 14.2 |   |
| John      N. Fermanis (4)                                                    |   |           | 158,000   |   |   |   | 1.2 |   |
| Hal      N. Siegel, Ph.D. (5)                                                |   |           | 192,000   |   |   |   | 1.5 |   |
| Lance      K. Gordon, Ph.D. (6)                                              |   |           | 100,000   |   |   |   | * |   |
| Robert      J. Hariri, M.D., Ph.D. (7)                                       |   |           | 321,055   |   |   |   | 2.4 |   |
| Theodore      E. Staahl, M.D. (8)                                            |   |           | 451,407   |   |   |   | 3.4 |   |
| Jerome      B. Zeldis, M.D., Ph.D. (9)                                       |   |           | 100,000   |   |   |   | * |   |
|                                                                         |   |           |      |   |   |   |   |   |
|                                                                         |   |           |      |   |   |   |   |   |
| All current executive officers      and directors as a group (7 persons)(10) |   |           | 3,320,305 |   |   |   | 22.2 |   |

| *  |   | Represents      beneficial ownership of less than one percent of the Company’s Common      Stock. |
|---------|--------|---------------------------------------------------------------------------------------------------------|

| (1)    |   | Consists      of 31,043 shares of Common Stock, 1,500,000 shares issuable upon the      exercise of outstanding warrants exercisable within 60 days of      April 1, 2009, an aggregate of $3,000,000 in secured convertible      notes convertible into Common Stock at $1.50 per share (the “Notes”) and      an aggregate of $218,889 secured convertible notes convertible at a price      of no less than $0.30 per share (the “Interest      Notes”).  However, by contract, the warrants cannot be exercised      nor may the Notes be converted if after the exercise or conversion the      beneficial owner would own more than 9.99% of the outstanding shares of      common stock, unless waived by YA Global Investments, L.P. upon 65 days      notice.  The Interest Notes may not be converted if after the      conversion the beneficial owner would own more than 9.98% of the      outstanding shares of common stock.  Accordingly only 1,419,175      of shares issuable upon the exercise of warrants and conversion of secured      convertible notes are included.  The business address of YA      Global Investments, L.P. is 101 Hudson Street, Suite 3700, Jersey City, NJ      07302.                                                                                                                                                                                                                                                                                                                                               |
|--------|--------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
|   |   |                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                         |
| (2)    |   | Represents      securities owned by Brencourt Multi-Strategy Master, Ltd., Schreckhorn      Fund Limited, Brencourt Enhanced Multi-Strategy L.P. and Brencourt      Enhanced Multi-Strategy International, Ltd., over which Brencourt      Advisors, LLC has investment and voting control.  Consists of      301,269 shares of Common Stock, 2,500,000 shares issuable upon the      exercise of outstanding warrants exercisable within 60 days of      April 1, 2009, an aggregate of $5,000,000 in secured convertible      notes convertible into Common Stock at $1.55 per share and an aggregate of      $250,000 secured convertible notes convertible at a price of no less than      $0.30 per share. However, by contract, the warrants cannot be exercised if      after the exercise the beneficial owner would own more than 4.99% of the      outstanding shares of common stock (the “Ownership Limitation”), unless      such Ownership Limitation is increased or decreased by the holder upon 61      days’ prior notice to the Company subject to a maximum Ownership      Limitation of 9.99%.  The secured convertible notes may not be      converted if after the conversion the beneficial owner would own more than      9.98% of the outstanding shares of common stock.  Accordingly      only 1,117,378  of shares issuable upon the exercise of warrants      and conversion of secured convertible notes are included.  The      address for Brencourt Advisors LLC is 600 Lexington Avenue, 8th      Floor, New York, NY10022. |

| (3)    |   | Consists      of 1,038,727 shares of Common Stock, 144,116 shares issuable upon the      exercise of outstanding warrants, and 815,000 shares issuable upon the      exercise of stock options exercisable within 60 days of April 1,      2009. |
|--------|--------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
|   |   |                                                                                                                                                                                                                                             |
| (4)    |   | Consists      of 10,000 shares of Common Stock, 8,000 shares issuable upon the exercise      of outstanding warrants, and 140,000 shares issuable upon the exercise of      stock options exercisable within 60 days of April 1,  2009.          |
|   |   |                                                                                                                                                                                                                                             |
| (5)    |   | Consists      of 11,000 shares of Common Stock, 1,000 shares issuable upon the exercise      of outstanding warrants, and 180,000 shares issuable upon the exercise of      stock options exercisable within 60 days of April 1,  2009.          |

----

|   |   |                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                           |
|--------|--------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| (6)    |   | Consists      of 100,000 shares issuable upon the exercise of stock options exercisable      within 60 days of April 1, 2009.                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                  |
|   |   |                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                           |
| (7)    |   | Consists      of 89,805 shares of Common Stock, 31,250 shares issuable upon the exercise      of outstanding warrants and 200,000 shares issuable upon the exercise of      stock options exercisable within 60 days of April 1, 2009. Includes 27,305      shares of Common Stock and 200,000 shares issuable upon the exercise of      stock options exercisable within 60 days of April 1, 2009 held by Dr.      Hariri and includes 62,500 shares of Common Stock and 31,250 shares      issuable upon the exercise of outstanding warrants exercisable within 60      days of April 1, 2009 held by The Hariri Family Limited Partnership, a      partnership that Dr. Hariri is the administrative manager      thereof. |
|   |   |                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                           |
| (8)    |   | Consists      of 343,407 shares of Common Stock, 8,000 shares issuable upon the exercise      of outstanding warrants, and 100,000 shares issuable upon the exercise of      stock options exercisable within 60 days of April 1,  2009.                                                                                                                                                                                                                                                                                                                                                                                                                                                                                       |

| (9)    |   | Consists      of 100,000 shares issuable upon the exercise of stock options exercisable      within 60 days of April 1, 2009.                                                                                                                                                                                                                                                                                                                                                                                                               |
|--------|--------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
|   |   |                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                        |
| (10)   |   | Consists      of 1,492,938 shares of Common Stock, 238,164 shares issuable upon the      exercise of outstanding warrants and 1,635,000 shares issuable upon the      exercise of stock options exercisable within 60 days of April 1, 2009.      Includes 62,500 shares of Common Stock and 31,250 shares issuable upon the      exercise of outstanding warrants exercisable within 60 days of April 1,      2009 held by The Hariri Family Limited Partnership, a partnership that Dr.      Hariri is the administrative managerthereof. |

ITEM13. CERTAIN RELATIONSHIPS AND RELATED TRANSACTIONS, AND DIRECTORINDEPENDENCE

|                         |   | December      31, 2008 |   |   | December      31, 2007 |   |
|------------------------------|--------|------------------------|--------|--------|------------------------|--------|
| (i)      Audit Fees          |   | $                      | 77,975 |   |                   | $      | 68,050 |   |
| (ii)      Audit Related Fees |   |                   | -      |   |                   |   | - |   |
| (iii)      Tax Fees          |   |                   | -      |   |                   |   | - |   |
| (iv)      All Other Fees     |   |                   | 5,000  |   |                   |   | 3,300 |   |
| Total      fees              |   | $                      | 82,975 |   |                   | $      | 71,350 |   |

----

ITEM 15.  EXHIBITS AND FINANCIAL STATEMENTSCHEDULES

| 1. | Financial      Statements: See “Index to Consolidated Financial Statements” in Part II,      Item 8 of this annual report on Form10-K. |
|----|----------------------------------------------------------------------------------------------------------------------------------------------------|

| 2. | Financial      Statement Schedule: Not applicable. |
|----|----------------------------------------------------|

| 3. | Exhibits: |
|----|-----------|

| Exhibit Number | Description of Exhibit                                                                                                                                                                                                                                                                                                     |
|----------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| 2.1            | Agreement      and Plan of Merger dated July 2, 2003 among the Registrant, GPN      Acquisition Corporation and ImmuneRegen BioSciences, Inc. (incorporated by      reference to exhibit 2 of the Registrant's current report on Form 8-k      filed with the Securities and Exchange Commission on July 7,      2003).    |
|           |                                                                                                                                                                                                                                                                                                                       |
| 3.1            | Certificate      of Incorporation filed with the Delaware Secretary of State on June 4,      1985 (incorporated by reference to exhibit 3.1 of the Registrant's annual      report on Form 10-KSB for the year ended December 31, 2001 filed with the      Securities and Exchange Commission on April 16, 2002).          |
|           |                                                                                                                                                                                                                                                                                                                       |
| 3.1(a)         | Certificate      of Amendment filed with the Delaware Secretary of State on July 16, 1987      (incorporated by reference to exhibit 3.1(a) of the Registrant's annual      report on Form 10-KSB for the year ended December 31, 2001 filed with the      Securities and Exchange Commission on April 16, 2002).          |
|           |                                                                                                                                                                                                                                                                                                                       |
| 3.1(b)         | Certificate      of Amendment filed with the Delaware Secretary of State on February 3,      1992 (incorporated by reference to exhibit 3.1(b) of the Registrant's      annual report on Form 10-KSB for the year ended December 31, 2001 filed      with the Securities and Exchange Commission on April 16,      2002).  |
|           |                                                                                                                                                                                                                                                                                                                       |
| 3.1(c)         | Certificate      of Amendment filed with the Delaware Secretary of State on November 23,      1992 (incorporated by reference to exhibit 3.1(c) of the Registrant's      annual report on Form 10-KSB for the year ended December 31, 2001 filed      with the Securities and Exchange Commission on April 16,      2002). |
|           |                                                                                                                                                                                                                                                                                                                       |
| 3.1(d)         | Certificate      of Amendment filed with the Delaware Secretary of State on December 15,      1994 (incorporated by reference to exhibit 3.1(d) of the Registrant's      annual report on Form 10-KSB for the year ended December 31, 2001 filed      with the Securities and Exchange Commission on April 16,      2002). |
|           |                                                                                                                                                                                                                                                                                                                       |
| 3.1(e)         | Certificate      of Amendment filed with the Delaware Secretary of State on November 7,      1995 (incorporated by reference to exhibit 3.1(e) of the Registrant's      annual report on Form 10-KSB for the year ended December 31, 2001 filed      with the Securities and Exchange Commission on April 16,      2002).  |
|           |                                                                                                                                                                                                                                                                                                                       |
| 3.1(f)         | Certificate      of Amendment filed with the Delaware Secretary of State on December 30,      1996 (incorporated by reference to exhibit 3.1(f) of the Registrant's      annual report on Form 10-KSB for the year ended December 31, 2001 filed      with the Securities and Exchange Commission on April 16,      2002). |
|           |                                                                                                                                                                                                                                                                                                                       |
| 3.1(g)         | Certificate      of Amendment filed with the Delaware Secretary of State on November 8,      2000 (incorporated by reference to exhibit 3.1(h) of the Registrant's      annual report on Form 10-KSB for the year ended December 31, 2001 filed      with the Securities and Exchange Commission on April 16,      2002).  |
|           |                                                                                                                                                                                                                                                                                                                       |
| 3.1(h)         | Certificate      of Amendment filed with the Delaware Secretary of State on June 27, 2008      (incorporated by reference to Appendix A to the definitive proxy statement      Schedule 14A filed with the Securities and Exchange Commission on May 9,      2008).                                                        |
|           |                                                                                                                                                                                                                                                                                                                       |
| 3.1(i)         | Certificate      of Amendment filed with the Delaware Secretary of State on July 10, 2008      (incorporated by reference to Appendix C to the definitive proxy statement      Schedule 14A filed with the Securities and Exchange Commission on May 9,      2008).                                                        |
|           |                                                                                                                                                                                                                                                                                                                       |
| 3.2            | Amended      and Restated Bylaws of the Registrant dated as of April 19, 2008      (incorporated by reference to Appendix C to the definitive proxy statement      Schedule 14A  filed with the Securities and Exchange Commission      on May 9, 2008).                                                         |
|           |                                                                                                                                                                                                                                                                                                                       |
| 4.1            | Specimen      Common Stock Certificate (incorporated by reference to exhibit 4.1 of the      Registrant's registration statement on Form SB-2 (File No. 333-120784)      filed with the Securities and Exchange Commission on November 24,      2004).                                                                     |
|           |                                                                                                                                                                                                                                                                                                                       |
| 4.2            | 2003      Stock Option, Deferred Stock and Restricted Stock Plan (incorporated by      reference to exhibit 4.1 of the Registrant's registration statement on      Form S-8 (file no. 333-113511) filed with the Securities and Exchange      Commission on March 11, 2004).                                               |
|           |                                                                                                                                                                                                                                                                                                                       |

----

| Exhibit Number | Description of Exhibit                                                                                                                                                                                                                                                                                                                                                                     |
|----------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
|           |                                                                                                                                                                                                                                                                                                                                                                                       |
| 4.3            | Amendment      No. 1 to IR BioSciences Holdings, Inc. 2003 Stock Option, Deferred Stock      and Restricted Stock Plan (incorporated by reference to Annex B to the      definitive Proxy Statement on Schedule 14A filed with the Securities and      Exchange Commission on June 5, 2006).                                                                                               |
|           |                                                                                                                                                                                                                                                                                                                                                                                       |
| 4.4            | Amendment      No. 2 (titled “Amendment No. 3”) to IR BioSciences Holdings, Inc. 2003      Stock Option, Deferred Stock and Restricted Stock Plan (incorporated by      reference to Appendix B to the definitive Proxy Statement on Schedule 14A      filed with the Securities and Exchange Commission on May 9,      2008).                                                 |
|           |                                                                                                                                                                                                                                                                                                                                                                                       |
| 4.5            | Form      of Warrant by and between the Registrant and each of the Investors or      Creditors, as the case may be, who entered into an Agreement filed as      Exhibit 10.6, 10.7, 10.8 or 10.9 herewith (incorporated by reference to      exhibit 4.1 of the Registrant's current report on Form 8-K filed with the      Securities and Exchange Commission on October 19,2004).        |
|           |                                                                                                                                                                                                                                                                                                                                                                                       |
| 4.6            | Form      of Registration Rights (Annex A to Subscription Agreement) by and between      the Registrant and each of the Investors who entered into the Agreements      filed as Exhibits 10.6 and 10.8 herewith (incorporated by reference to      exhibit 4.2 of the Registrant's current report on Form 8-K filed with the      Securities and Exchange Commission on October 19,2004).  |
|           |                                                                                                                                                                                                                                                                                                                                                                                       |
| 4.7            | Form      of Anti-Dilution Rights (Annex B to Subscription Agreement) by and between      the Registrant and each of the Investors who entered into the Agreements      filed as Exhibits 10.6 and 10.8 herewith (incorporated by reference to      exhibit 4.3 of the Registrant's current report on Form 8-K filed with the      Securities and Exchange Commission on October 19,2004). |
|           |                                                                                                                                                                                                                                                                                                                                                                                       |
| 4.8            | Promissory      Note issued from the Registrant to SBM Certificate Company as of April 28,      2004 (incorporated by reference to exhibit 4.6 of the Registrant's      registration statement on Form SB-2 (File No. 333-120784) filed with the      Securities and Exchange Commission on November 24,  2004).                                                                           |
|           |                                                                                                                                                                                                                                                                                                                                                                                       |
| 4.8            | Form      of Warrant by and between the Registrant and each of the investors who      entered into the Subscription Agreements filed as Exhibits 10.18, 10.19      and 10.20 herewith (incorporated by reference from Exhibit 4.1 to the      Quarterly Report on Form 10-QSB as filed with the Securities and Exchange      Commission on November 14, 2006).                             |
|           |                                                                                                                                                                                                                                                                                                                                                                                       |
| 4.10           | 8%      Secured Convertible Debenture due December 31, 2010, issued to YA Global      Investments, L.P., dated January 3, 2008 (incorporated by reference from      Exhibit 4.1 to the Current Report on Form 8-K as filed with the Securities      and Exchange Commission on January 9, 2008).                                                                                           |
|           |                                                                                                                                                                                                                                                                                                                                                                                       |
| 4.11           | Common      Stock Purchase Warrant, issued to YA Global Investments, L.P., dated      January 3, 2008 (incorporated by reference from Exhibit 4.2 to the Current      Report on Form 8-K as filed with the Securities and Exchange Commission on      January 9, 2008).                                                                                                                    |
|           |                                                                                                                                                                                                                                                                                                                                                                                       |
| 4.12           | 8%      Secured Convertible Debenture due May 31, 2011 in the amount of      $1,000,000, issued to YA Global Investments, L.P., dated June 12, 2008      (incorporated by reference from Exhibit 4.1 to the Current Report on Form      8-K as filed with the Securities and Exchange Commission on June 17,      2008)                                                                    |
|           |                                                                                                                                                                                                                                                                                                                                                                                       |
| 4.13           | Amendment      Number 1 to 8% Secured Convertible Debenture in the amounts of $2,000,000      and $1,000,000, issued to YA Global Investments, L.P., dated January 3,      2008 and June 12, 2008, respectively (incorporated by reference from      Exhibit 4.1 to the Current Report on Form 8-K as filed with the Securities      and Exchange Commission on July 23, 2008).            |
|           |                                                                                                                                                                                                                                                                                                                                                                                       |
| 4.14           | Waiver      of Application of Provisions Under Secured Convertible Debenture between      the Company and YA Global Investments, L.P. dated July 18, 2008      (incorporated by reference from Exhibit 4.2 to the Current Report on Form      8-K as filed with the Securities and Exchange Commission on July 23,      2008).                                                             |
|           |                                                                                                                                                                                                                                                                                                                                                                                       |
| 4.15           | Form      of 10% Secured Convertible Debenture due August 8, 2013 dated August 8,      2008 issued to Funds Managed by Brencourt Advisors LLC (incorporated by      reference from Exhibit 4.1 to the Current Report on Form 8-K as filed with      the Securities and Exchange Commission on August 11,  2008).                                                                           |
|           |                                                                                                                                                                                                                                                                                                                                                                                       |
| 4.16           | Form      of Common Stock Purchase Warrant dated August 8, 2008 issued to Funds      Managed by Brencourt Advisors LLC (incorporated by reference from Exhibit      4.2 to the Current Report on Form 8-K as filed with the Securities and      Exchange Commission on August 11, 2008)                                                                                                    |
|           |                                                                                                                                                                                                                                                                                                                                                                                       |

----

| Exhibit Number | Description of  Exhibit |
|----------------|-------------------------|

| 4.17    | Amendment      Number 2 to 8% Secured Convertible Debenture in the amount of $2,000,000      issued to YA Global Investments, L.P., dated January 3, 2008 (incorporated      by reference from Exhibit 4.3 to the Current Report on Form 8-K as filed      with the Securities and Exchange Commission on August 11,      2008).                                                              |
|---------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
|    |                                                                                                                                                                                                                                                                                                                                                                                          |
| 4.18    | Amendment      Number 2 to 8% Secured Convertible Debenture in the amount of $1,000,000      issued to YA Global Investments, L.P., dated June 12, 2008 (incorporated      by reference from Exhibit 4.4 to the Current Report on Form 8-K as filed      with the Securities and Exchange Commission on August 11,      2008)                                                                 |
|    |                                                                                                                                                                                                                                                                                                                                                                                          |
| 4.19    | Amendment      Number 1 to Common Stock Purchase Warrant, issued to YA Global      Investments, L.P., dated August 8, 2008 (incorporated by reference from      Exhibit 4.5 to the Current Report on Form 8-K as filed with the Securities      and Exchange Commission on August 11, 2008)                                                                                                   |
|    |                                                                                                                                                                                                                                                                                                                                                                                          |
| 4.20    | Common      Stock Purchase Warrant, issued to YA Global Investments, L.P., dated      August 8, 2008 incorporated by reference from Exhibit 4.6 to the Current      Report on Form 8-K as filed with the Securities and Exchange Commission on      August 11, 2008).                                                                                                                         |
|    |                                                                                                                                                                                                                                                                                                                                                                                          |
| 10.1    | License      Agreement dated December 16, 2002 among ImmuneRegen BioSciences, Inc., a      subsidiary of the Registrant, David Harris and Mark Witten (incorporated      by reference to exhibit 10.4 of the Registrant's registration statement on      Form SB-2 (File No. 333-120784) filed with the Securities and Exchange      Commission on November 24, 2004).                        |
|    |                                                                                                                                                                                                                                                                                                                                                                                          |
| 10.1(a) | First      Amendment to License Agreement dated December 20, 2002 among ImmuneRegen      BioSciences, Inc., a subsidiary of the Registrant, David Harris and Mark      Witten (incorporated by reference to exhibit 10.4(a) of the Registrant's      registration statement on Form SB-2 (File No. 333-120784) filed with the      Securities and Exchange Commission on November 24,  2004). |
|    |                                                                                                                                                                                                                                                                                                                                                                                          |
| 10.1(b) | Second      Amendment to License Agreement dated June 26, 2003 among ImmuneRegen      BioSciences, Inc., a subsidiary of the Registrant, David Harris and Mark      Witten (incorporated by reference to exhibit 10.4(b) of the Registrant's      registration statement on Form SB-2 (File No. 333-120784) filed with the      Securities and Exchange Commission on November 24,  2004).    |
|    |                                                                                                                                                                                                                                                                                                                                                                                          |
| 10.1(c) | Assignment      Agreement dated February 23, 2005 between ImmuneRegen BioSciences, Inc., a      subsidiary of the Registrant and Mark Witten (incorporated by reference to      exhibit 10.4(c) of the Registrant's registration statement on Form SB-2      (File No. 333-120784) filed with the Securities and Exchange Commission on      July 20, 2005).                                  |
|    |                                                                                                                                                                                                                                                                                                                                                                                          |
| 10.1(d) | Assignment      Agreement dated February 23, 2005 among ImmuneRegen BioSciences, Inc., a      subsidiary of the Registrant, David Harris and Mark Witten (incorporated      by reference to exhibit 10.4(d) of the Registrant's registration statement      on Form SB-2 (File No. 333-120784) filed with the Securities and Exchange      Commission on July 20, 2005).                      |
|    |                                                                                                                                                                                                                                                                                                                                                                                          |
| 10.1(e) | Assignment      Agreement dated November 7, 2005 between ImmuneRegen BioSciences, Inc., a      subsidiary of the Registrant and Mark Witten (incorporated by reference to      exhibit 10.4(e) of the Registrant's registration statement on Form SB-2      (File No. 333-120784) filed with the Securities and Exchange Commission on      November 16, 2005).                               |
|    |                                                                                                                                                                                                                                                                                                                                                                                          |
| 10.1(f) | Assignment      Agreement dated November 7, 2005 between ImmuneRegen BioSciences, Inc., a      subsidiary of the Registrant and Mark Witten (incorporated by reference to      exhibit 10.4(f) of the Registrant's registration statement on Form SB-2      (File No. 333-120784) filed with the Securities and Exchange Commission on      February 22, 2006).                               |
|    |                                                                                                                                                                                                                                                                                                                                                                                          |
| 10.1(g) | Assignment      Agreement dated November 7, 2005 between ImmuneRegen BioSciences, Inc., a      subsidiary of the Registrant and Mark Witten (incorporated by reference to      exhibit 10.4(g) of the Registrant's registration statement on Form SB-2      (File No. 333-120784) filed with the Securities and Exchange Commission on      November 16, 2005).                               |
|    |                                                                                                                                                                                                                                                                                                                                                                                          |
| 10.1(h) | Assignment      Agreement dated November 7, 2005 between ImmuneRegen BioSciences, Inc., a      subsidiary of the Registrant and Mark Witten (incorporated by reference to      exhibit 10.4(h) of the Registrant's registration statement on Form SB-2      (File No. 333-120784) filed with the Securities and Exchange Commission on      November 16, 2005).                               |
|    |                                                                                                                                                                                                                                                                                                                                                                                          |
| 10.2    | Lease      Agreement dated July 1, 2004 between ImmuneRegen BioSciences, Inc., a      subsidiary of the Registrant, and The Clayton Companies (incorporated by      reference to exhibit 10.5 of the Registrant's registration statement on      Form SB-2 (File No. 333-120784) filed with the Securities and Exchange      Commission on November 24, 2004).                                |
|    |                                                                                                                                                                                                                                                                                                                                                                                          |
| 10.3    | Form      of Subscription Agreement entered into as of October 13, 2004 between the      Registrant and each of the Investors set forth on the Schedule of      Investors thereto (incorporated by reference to exhibit 10.1 of the      Registrant's current report on Form 8-K filed with the Securities and      Exchange Commission on October 19, 2004).                                 |
|    |                                                                                                                                                                                                                                                                                                                                                                                          |
| 10.4    | Form      of Settlement Agreement entered into as of October 13, 2004 between the      Registrant and each of the Creditors set forth on the Schedule of      Creditors thereto (incorporated by reference to exhibit 10.2 of the      Registrant's current report on Form 8-K filed with the Securities and      Exchange Commission on October 19, 2004).                                   |
|    |                                                                                                                                                                                                                                                                                                                                                                                          |
| 10.5    | Form      of Subscription Agreement entered into as of October 26, 2004 between the      Registrant and each of the Investors set forth on the Schedule of      Investors thereto (incorporated by reference to exhibit 10.1 of the      Registrant's current report on Form 8-K filed with the Securities and      Exchange Commission on October 27,2004).                                  |

----

| Exhibit Number | Description of  Exhibit |
|----------------|-------------------------|

| 10.6   | Form      of Settlement Agreement entered into as of October 26, 2004 between the      Registrant and each of the Creditors set forth on the Schedule of      Creditors thereto (incorporated by reference to exhibit 10.2 of the      Registrant's current report on Form 8-K filed with the Securities and      Exchange Commission on October 27, 2004).                                     |
|--------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
|   |                                                                                                                                                                                                                                                                                                                                                                                            |
| 10.7   | Employment      Agreement dated August 10, 2005 by and between the Registrant and Michael      K. Wilhelm (incorporated by reference to exhibit 10.1 of the Registrant's      quarterly report on Form 10-QSB for the three months ended September 30,      2005).                                                                                                                              |
|   |                                                                                                                                                                                                                                                                                                                                                                                            |
| 10.8   | Change      of Control Agreement dated August 10, 2005 by and between the Registrant      and Michael K. Wilhelm (incorporated by reference to exhibit 10.2 of the      Registrant's quarterly report on Form 10-QSB for the three months ended      September 30, 2005).                                                                                                                       |
|   |                                                                                                                                                                                                                                                                                                                                                                                            |
| 10.9   | Severance      Agreement dated November 7, 2005 by and between the Registrant and Michael      K. Wilhelm (incorporated by reference to exhibit 10.3 of the Registrant's      quarterly report on Form 10-QSB for the three months ended September 30,      2005).                                                                                                                              |
|   |                                                                                                                                                                                                                                                                                                                                                                                            |
| 10.10  | Authorization      for Regulatory Contact dated November 7, 2005 between ImmuneRegen      BioSciences, Inc., a subsidiary of the Registrant, and Synergos, Inc.      (incorporated by reference to exhibit 10.14 of the Registrant's      registration statement on Form SB-2 (File No. 333-120784) filed with the      Securities and Exchange Commission on February 22,  2006).              |
|   |                                                                                                                                                                                                                                                                                                                                                                                            |
| 10.11  | Proforma      invoice/quotation dated November 7, 2005 from Sigma-Aldrich, Inc. to      ImmuneRegen BioSciences, Inc., a subsidiary of the Registrant      (incorporated by reference to exhibit 10.15 of the Registrant's      registration statement on Form SB-2 (File No. 333-120784) filed with the      Securities and Exchange Commission on November 16,  2005).                        |
|   |                                                                                                                                                                                                                                                                                                                                                                                            |
| 10.12  | Letter      of acceptance dated October 2, 2003, from Huntingdon Life Sciences to      ImmuneRegen BioSciences, Inc., a subsidiary of the Registrant      (incorporated by reference to exhibit 10.16 of the Registrant's      registration statement on Form SB-2 (File No. 333-120784) filed with the      Securities and Exchange Commission on February 22,  2006).                         |
|   |                                                                                                                                                                                                                                                                                                                                                                                            |
| 10.13  | Price      Quotation dated June 27, 2003 received by ImmuneRegen BioSciences, Inc., a      subsidiary of the Registrant from AppTec Laboratory Services (incorporated      by reference to exhibit 10.17 of the Registrant's registration statement      on Form SB-2 (File No. 333-120784) filed with the Securities and Exchange      Commission on February 22, 2006).                       |
|   |                                                                                                                                                                                                                                                                                                                                                                                            |
| 10.14  | Consulting      Agreement dated March 15, 2005 between ImmuneRegen BioSciences, Inc., a      subsidiary of the Registrant and Dr. Hal Siegel, Ph.D. (Siegel      Consultancy) (incorporated by reference to exhibit 10.18 of the      Registrant's registration statement on Form SB-2 (File No. 333-120784)      filed with the Securities and Exchange Commission on February 22,      2006). |
|   |                                                                                                                                                                                                                                                                                                                                                                                            |
| 10.15  | Consulting      Agreement dated November 3, 2005 between ImmuneRegen BioSciences, Inc., a      subsidiary of the Registrant and Dr. Jack Caravelli, Ph.D (incorporated by      reference to exhibit 10.19 of the Registrant's registration statement on      Form SB-2 (File No. 333-120784) filed with the Securities and Exchange      Commission on February 22, 2006).                      |
|   |                                                                                                                                                                                                                                                                                                                                                                                            |
| 10.16  | Consulting      Agreement dated July 29, 2005 between ImmuneRegen BioSciences, Inc., a      subsidiary of the Registrant and Dr. Kelly McQueen, MD, MPH (incorporated      by reference to exhibit 10.20 of the Registrant's registration statement      on Form SB-2 (File No. 333-120784) filed with the Securities and Exchange      Commission on February 22, 2006).                       |
|   |                                                                                                                                                                                                                                                                                                                                                                                            |
| 10.17  | Form      of Subscription Agreement entered into as of December 6, 2006 between the      Registrant and each of the Investors set forth on the Schedule of      Investors contained therein (incorporated by reference from Exhibit 10.1      to the Report on Form 8-K as filed with the Securities and Exchange      Commission on December 7, 2006).                                         |
|   |                                                                                                                                                                                                                                                                                                                                                                                            |
| 10.18  | Form      of Subscription Agreement entered into as of October 4, 2006 between the      Registrant and each of the Investors set forth on the Schedule of      Investors contained therein. (incorporated by reference from Exhibit 10.2      to the Quarterly Report on Form 10-QSB as filed with the Securities and      Exchange Commission on November 14, 2006).                           |
|   |                                                                                                                                                                                                                                                                                                                                                                                            |
| 10.19  | Form      of Subscription Agreement entered into as of October 26, 2006 between the      Registrant and each of the Investors set forth on the Schedule of      Investors contained therein (incorporated by reference from Exhibit 10.2      to the Quarterly Report on Form 10-QSB as filed with the Securities and      Exchange Commission on November 14, 2006).                           |
|   |                                                                                                                                                                                                                                                                                                                                                                                            |
| 10.20  | Standard      Form of Director Indemnification Agreement (incorporated by reference from      Exhibit 10.21 to the Annual Report on Form 10-KSB/A as filed with the      Securities and Exchange Commission on April 30, 2007).                                                                                                                                                                 |
|   |                                                                                                                                                                                                                                                                                                                                                                                            |
| 10.21  | Agreement      dated May 14, 2007 by and between the Company and Dr. Lance K. Gordon      (incorporated by reference from Exhibit 10.1 to the Current Report on Form      8-K as filed with the Securities and Exchange Commission on May 17,      2007).                                                                                                                                       |
|   |                                                                                                                                                                                                                                                                                                                                                                                            |
| 10.22  | Agreement      dated August 14, 2007 by and between the Company and Dr. Robert J. Hariri      Gordon (incorporated by reference from Exhibit 10.1 to the Current Report      on Form 8-K as filed with the Securities and Exchange Commission on August      17, 2007).                                                                                                                         |
|   |                                                                                                                                                                                                                                                                                                                                                                                            |
| 10.23  | Office      Lease dated October 25, 2007 by and between the Company and Bay Colony      Executive Center-West, a division of BC Management Company, Inc.      (incorporated by reference from Exhibit 10.1 to the Current Report on Form      8-K as filed with the Securities and Exchange Commission on October 30,      2007).                                                               |
|   |                                                                                                                                                                                                                                                                                                                                                                                            |

----

| Exhibit Number | Description of  Exhibit |
|----------------|-------------------------|

| 10.24  | Amendment      for an Extension to Lease Term and to Relocate to Suite 280 at the Bay      Colony Executive Center - East dated March 17, 2009 by and between the      Company and Bay Colony Executive Center-West, a division of BC Management      Company, Inc. (incorporated by reference from Exhibit 10.1 to the Current      Report on Form 8-K as filed with the Securities and Exchange Commission on      March 20, 2009). |
|--------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
|   |                                                                                                                                                                                                                                                                                                                                                                                                                                  |
| 10.25  | Securities      Purchase Agreement, dated as of January 3, 2008, by and among the Company,      YA Global Investments, L.P., and ImmuneRegen BioSciences, Inc.      (incorporated by reference from Exhibit 10.1 to the Current Report on Form      8-K as filed with the Securities and Exchange Commission on January 9,      2008).                                                                                                |
|   |                                                                                                                                                                                                                                                                                                                                                                                                                                  |
| 10.26  | Guaranty      Agreement dated as of January 3, 2008, executed by ImmuneRegen      BioSciences, Inc. in favor of YA Global Investments,      L.P. (incorporated by reference from Exhibit 10.2 to the Current      Report on Form 8-K as filed with the Securities and Exchange Commission on      January 9, 2008).                                                                                                              |
|   |                                                                                                                                                                                                                                                                                                                                                                                                                                  |
| 10.27  | Security      Agreement dated as of January 3, 2008, by and among the Company, YA Global      Investments, L.P. and ImmuneRegen BioSciences, Inc. (incorporated by      reference from Exhibit 10.3 to the Current Report on Form 8-K as filed      with the Securities and Exchange Commission on January 9,      2008).                                                                                                             |
|   |                                                                                                                                                                                                                                                                                                                                                                                                                                  |
| 10.28  | Patent      Security Agreement dated as of January 3, 2008, by and among the Company,      YA Global Investments, L.P. and ImmuneRegen BioSciences, Inc.      (incorporated by reference from Exhibit 10.3 to the Current Report on Form      8-K as filed with the Securities and Exchange Commission on January 9,      2008).                                                                                                      |
|   |                                                                                                                                                                                                                                                                                                                                                                                                                                  |
| 10.29  | Unsecured      12% Senior Promissory Note dated April 13, 2006 (incorporated by reference      from Exhibit 10.1 to the Current Report on Form 8-K as filed with the      Securities and Exchange Commission on April 19, 2006).                                                                                                                                                                                                      |
|   |                                                                                                                                                                                                                                                                                                                                                                                                                                  |
| 10.30  | Unsecured      12% Senior  Promissory Note dated July 25, 2006 in the amount of      $250,000 (incorporated by reference from Exhibit 10.1 to the Current      Report on Form 8-K as filed with the Securities and Exchange Commission on      August 4, 2006).                                                                                                                                                             |
|   |                                                                                                                                                                                                                                                                                                                                                                                                                                  |
| 10.31  | Unsecured      12% Senior Promissory Note dated August 1, 2006 in the amount of $50,000      (incorporated by reference from Exhibit 10.2 to the Current Report on Form      8-K as filed with the Securities and Exchange Commission on August 4,      2006).                                                                                                                                                                        |
|   |                                                                                                                                                                                                                                                                                                                                                                                                                                  |
| 10.32  | Unsecured      12% Senior Promissory Note dated August 1, 2006 in the amount of $20,000      (incorporated by reference from Exhibit 10.3 to the Current Report on Form      8-K as filed with the Securities and Exchange Commission on August 4,      2006).                                                                                                                                                                        |
|   |                                                                                                                                                                                                                                                                                                                                                                                                                                  |
| 10.33  | Employment      Agreement dated January 1, 2008 by and between the Company and John      Fermanis (incorporated by reference from Exhibit 10.1 to the Current      Report on Form 8-K as filed with the Securities and Exchange Commission on      April 8, 2008).                                                                                                                                                                    |
|   |                                                                                                                                                                                                                                                                                                                                                                                                                                  |
| 10.34  | Change      of Control Agreement dated January 1, 2008 by and between the Company and      John Fermanis (incorporated by reference from Exhibit 10.2 to the Current      Report on Form 8-K as filed with the Securities and Exchange Commission on      April 8, 2008).                                                                                                                                                             |
|   |                                                                                                                                                                                                                                                                                                                                                                                                                                  |
| 10.35  | Securities      Purchase Agreement, dated as of August 8, 2008, by and among the Company,      ImmuneRegen BioSciences, Inc., and certain funds managed by Brencourt      Advisors, LLC (incorporated by reference from Exhibit 10.1 to the Current      Report on Form 8-K as filed with the Securities and Exchange Commission on      August 11, 2008).                                                                            |
|   |                                                                                                                                                                                                                                                                                                                                                                                                                                  |
| 10.36  | Guaranty      Agreement dated as of August 8, 2008, executed by ImmuneRegen BioSciences,      Inc. in favor of certain funds managed by Brencourt Advisors, LLC      (incorporated by reference from Exhibit 10.2 to the Current Report on Form      8-K as filed with the Securities and Exchange Commission on August 11,      2008).                                                                                               |
|   |                                                                                                                                                                                                                                                                                                                                                                                                                                  |
| 10.37  | Security      Agreement dated as of August 8, 2008, by and among the Company,      ImmuneRegen BioSciences, Inc., and certain funds managed by Brencourt      Advisors, LLC (incorporated by reference from Exhibit 10.3 to the Current      Report on Form 8-K as filed with the Securities and Exchange Commission on      August 11, 2008).                                                                                        |
|   |                                                                                                                                                                                                                                                                                                                                                                                                                                  |
| 10.38  | Patent      Security Agreement dated as of August 8, 2008, by and among the Company,      ImmuneRegen BioSciences, Inc. and certain funds managed by Brencourt      Advisors, LLC (incorporated by reference from Exhibit 10.4 to the Current      Report on Form 8-K as filed with the Securities and Exchange Commission on      August 11, 2008).                                                                                  |
|   |                                                                                                                                                                                                                                                                                                                                                                                                                                  |
| 10.39  | Employment      Agreement dated October 24, 2008 by and between the Company and Hal Siegel      (incorporated by reference from Exhibit 10.1 to the Current Report on Form      8-K as filed with the Securities and Exchange Commission on December 22,      2008).                                                                                                                                                                  |
|   |                                                                                                                                                                                                                                                                                                                                                                                                                                  |
| 10.40  | Change      of Control Agreement dated October 24, 2008 by and between the Company and      Hal Siegel (incorporated by reference from Exhibit 10.2 to the Current      Report on Form 8-K as filed with the Securities and Exchange Commission on      December 22, 2008).                                                                                                                                                           |
|   |                                                                                                                                                                                                                                                                                                                                                                                                                                  |
| 21.1   | Subsidiaries      of Registrant (incorporated by reference to exhibit 21.1 of the      Registrant's registration statement on Form SB-2 (File No. 333-120784)      filed with the Securities and Exchange Commission on November 24,      2004).                                                                                                                                                                                      |
|   |                                                                                                                                                                                                                                                                                                                                                                                                                                  |
| 23.1*  | Consent      of RBSM LLP                                                                                                                                                                                                                                                                                                                                                                                                              |

----

| Exhibit Number | Description of  Exhibit |
|----------------|-------------------------|

| 31.1         | Certification of Chief Executive Officer pursuant to      Item 601(b)(31) of Regulation S-K, as adopted pursuant to Section 302 of      the Sarbanes-Oxley Act of 2002.                                                                                                                                                                                                                                                                                                  |
|--------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
|         |                                                                                                                                                                                                                                                                                                                                                                                                                                                                     |
| 31.2         | Certification of Chief Financial Officer pursuant to      Item 601(b)(31) of Regulation S-K, as adopted pursuant to Section 302 of      the Sarbanes-Oxley Act of 2002.                                                                                                                                                                                                                                                                                                  |
|         |                                                                                                                                                                                                                                                                                                                                                                                                                                                                     |
| 32.1*        | Certifications      of Chief Executive Officer pursuant to 18 U.S.C. Section 1350 as adopted      pursuant to Section 906 of the Sarbanes-Oxley Act of    2002.**                                                                                                                                                                                                                                                                                                        |
|         |                                                                                                                                                                                                                                                                                                                                                                                                                                                                     |
| 32.2*        | Certifications      of Chief Financial Officer pursuant to 18 U.S.C. Section 1350 as adopted      pursuant to Section 906 of the Sarbanes-Oxley Act of    2002.**                                                                                                                                                                                                                                                                                                        |
| ____________ |                                                                                                                                                                                                                                                                                                                                                                                                                                                                     |
| *            | Previously      filed.                                                                                                                                                                                                                                                                                                                                                                                                                                                   |
|         |                                                                                                                                                                                                                                                                                                                                                                                                                                                                     |
| **           | This      exhibit shall not be deemed “filed” for purposes of Section 18 of the      Securities Exchange Act of 1934 or otherwise subject to the liabilities of      that section, nor shall it be deemed incorporated by reference in any      filing under the Securities Act of 1933 or the Securities Exchange Act of      1934, whether made before or after the date hereof and irrespective of any      general incorporation language in anyfilings. |

----

SIGNATURES

|                      |                                       |                                                                                                                                                                                                                  |
|---------------------------|--------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
|                      | IR      BIOSCIENCES HOLDINGS, INC.         |
|                      |                                       |                                                                                                                                                                                                                  |
| Date:      April 30, 2009 | By:                                        | /s/ Michael K.      Wilhelm                                |
|                      | Michael      K. Wilhelm                    |
|                      | President      and Chief Executive Officer |

|  SIGNATURE                                                                                                                                                                                                          |   |  TITLE                                                                             |   |  DATE          |
|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------|-----------------------------------------------------------------------------------------|--------|---------------------|
|                                                                                                                                                                                                                     |   |                                                                                    |   |                |
| /s/ Michael K.      Wilhelm                                                       |   | Chief      Executive Officer, President and Director (Principal Executive      Officer) |   | April      30, 2009 |
| Michael      K. Wilhelm                                                                                                                                                                                                  |   |                                                                                    |   |                |
|                                                                                                                                                                                                                     |   |                                                                                    |   |                |
| /s/ John N.      Fermanis                                |   | Chief      Financial Officer (Principal Financial and Accounting    Officer)            |   | April      30, 2009 |
| John      N. Fermanis                                                                                                                                                                                                    |   |                                                                                    |   |                |
|                                                                                                                                                                                                                     |   |                                                                                    |   |                |
| /s/ Theodore E. Staahl,      M.D.                                                                                         |   | Director                                                                                |   | April      30, 2009 |
| Theodore E. Staahl, M.D.                                                                                                                                                                                                 |   |                                                                                    |   |                |
|                                                                                                                                                                                                                     |   |                                                                                    |   |                |
| /s/ Hal N. Siegel,      Ph.D.                                                     |   | Director                                                                                |   | April      30, 2009 |
| Hal N. Siegel, Ph.D.                                                                                                                                                                                                     |   |                                                                                    |   |                |
|                                                                                                                                                                                                                     |   |                                                                                    |   |                |
| /s/ Lance K. Gordon,      Ph.D.                                                                                      |   | Director                                                                                |   | April      30, 2009 |
| Lance K. Gordon, Ph.D.                                                                                                                                                                                                   |   |                                                                                    |   |                |
|                                                                                                                                                                                                                     |   |                                                                                    |   |                |
| __________________________                                                                                                                                                                                               |   | Director                                                                                |   | April      30, 2009 |
| Robert J. Hariri, M.D.,    Ph.D.                                                                                                                                                                                         |   |                                                                                    |   |                |
|                                                                                                                                                                                                                     |   |                                                                                    |   |                |
| /s/ Jerome B. Zeldis, M.D.,      Ph.D.                                                                                                                            |   | Director                                                                                |   | April      30, 2009 |
| Jerome B. Zeldis, M.D.,    Ph.D.                                                                                                                                                                                         |   |                                                                                    |   |                |

----