##### Table of Contents



UNITED STATES
SECURITIES AND EXCHANGE COMMISSION
 Washington, D.C. 20549
 FORM 10-K
  þ
    
    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
 For the transition period from  to
 Commission file number: 001-15070
 RegeneRx Biopharmaceuticals, Inc.
  Delaware
    
    52-1253406State or other jurisdiction of
    
    (I.R.S. Employerincorporation or organization
    
    Identification No.)
 
 3 Bethesda Metro Center, Suite 630, Bethesda, MD
    
    20814(Address of principal executive offices)
    
    (Zip Code)
   Title of each class
    
    Name of each exchange on which registeredCommon Stock $0.001 par value,
    
    NYSE Amexincluding associated Series A ParticipatingCumulative Preferred Stock Purchase Rights
  
 o Yes þ No
 o Yes þ No
 Note
 þ o
 þ
 Rule 12b-2
 Large accelerated filer o
    
    Accelerated filer o
    
    Non-accelerated filer o
    
    Smaller reporting company þ(Do not check if a smaller reporting company)
 o þ




---



TABLE OF CONTENTS  PART IItem 1. BusinessItem 1A. Risk FactorsItem 1B. Unresolved Staff CommentsItem 2. PropertiesItem 3. Legal ProceedingsItem 4. Submission of Matters to a Vote of Security HoldersPART IIItem 5. Market for Registrants Common Equity, Related Stockholder Matters and Issuer Purchases of SecuritiesItem 6. Selected Financial DataItem 7. Managements Discussion and Analysis of Financial Condition and Results of OperationItem 7A. Quantitative and Qualitative Disclosures About Market RiskItem 8. Financial Statements and Supplementary DataItem 9. Changes in and Disagreements With Accountants on Accounting and Financial DisclosureItem 9A(T). Controls and ProceduresItem 9B. Other InformationPART IIIItem 10. Directors, Executive Officers and Corporate GovernanceItem 11. Executive CompensationItem 12. Security Ownership of Certain Beneficial Owners and Management and Related Stockholder MattersItem 13. Certain Relationships and Related Transactions, and Director IndependenceItem 14. Principal Accounting Fees and ServicesPART IVItem 15. Exhibits, Financial Statement SchedulesSIGNATURESINDEX TO FINANCIAL STATEMENTSEXHIBIT INDEXExhibit 10.4Exhibit 10.5Exhibit 10.6Exhibit 10.7Exhibit 23.1Exhibit 31.1Exhibit 31.2Exhibit 32.1Exhibit 32.2    Table of Contents  
 
 PART I
 This Annual Report on Form 10-K , including the section entitled Managements Discussion and
Analysis of Financial Condition and Results of Operations, contains forward-looking statements
regarding us and our business, financial condition, results of operations and prospects within the
meaning of the Private Securities Litigation Reform Act of 1995. Forward-looking statements may be
identified by the words project, believe, anticipate, plan, expect, estimate, intend,
should, would, could, will, may or other similar expressions. In addition, any statements
that refer to projections of our future financial performance, our clinical development programs
and schedules, our anticipated growth and trends in our business, and other characterizations of
future events or circumstances are forward-looking statements. We cannot guarantee that we will
achieve the plans, intentions or expectations expressed or implied in our forward-looking
statements. There are a number of important factors that could cause actual results, levels of
activity, performance or events to differ materially from those expressed or implied in the
forward-looking statements we make, including those described under Risk Factors set forth below.
In addition, any forward-looking statements we make in this document speak only as of the date of
this document, and we do not intend to update any such forward-looking statements to reflect events
or circumstances that occur after that date.
 
 
 Item 1. Business.
 General
 b
 
    
    RGN-137, a topically applied gel for hard-to-heal chronic dermal wounds;
 
    
    RGN-259, a sterile, preservative-free topical eye drop for ophthalmic wounds; and
 
    
    RGN-352, a parenteral, or injectable, formulation for systemic delivery of Tb4 to treat
cardiovascular disease. We are initially targeting our parenteral formulation for the
treatment of patients with an acute myocardial infarction, or heart attack.
 b
   2




---



##### Table of Contents



b b b in vitro in vitro
 Mechanism of Action, Research Studies and Potential Commercial Applications
 b b b
 b b b b
 b
 b in vivo b
 b b
  3




---



##### Table of Contents



b Nature b Circulation b b
 Clinical Development
  RGN-137 Clinical Trials
 Pressure ulcers. b 2
  Venous stasis ulcers. RGN-137 b 2
  4




---



##### Table of Contents



Epidermolysis bullosa . b
  Future Plans.
 RGN-259 Clinical Trials
 b b
 RGN-259 RGN-259
  5




---



##### Table of Contents



RGN-352 Clinical Trials
 b b
  Other Product Development Efforts
   6




---



##### Table of Contents



RGN-457 (inhaled formulation of T b 4) b
 Clinical Development Strategy.
  Cosmeceutical Strategy
 Manufacturing
 b
 b
  7




---



##### Table of Contents



Competition
  RGN-137 (topical gel) 
 RGN-259 (sterile eye drops) 
 RGN-352 (injectable) 
 RGN-457 (inhaled) 
 Cosmeceutical Products 
  8




---



##### Table of Contents



Government Regulation
      9




---



##### Table of Contents



b
 Proprietary Rights
 b
  10




---



##### Table of Contents



b b
 b b
 b
 Material Agreements
 Licensing Agreements.
 Defiante Farmaceutica, LDA. b b b b
 b
  11




---



##### Table of Contents



Clinical Development Agreements
 b b
 Employees
  Corporate Information
  Available Information
   12




---



##### Table of Contents



Item 1A. Risk Factors
 Risks Related to Our Liquidity and Need for Financing
 We estimate that our current liquidity and capital resources are sufficient to fund our
operations into early 2010. However, we will need substantial additional funds to expand
operations, which we may not be able to raise on favorable terms, or at all.
     We are seeking to maximize the value of our assets and to address our liabilities and raise
additional capital for our existing business. We are attempting to pursue asset out-licenses, asset
sales, mergers or similar strategic transactions. There can be no assurance that we will be
successful in executing a strategic transaction.
   13




---



##### Table of Contents



We have incurred losses since inception and expect to incur significant losses in the
foreseeable future and may never become profitable.
 b
  The recent downturn in the U.S. economy and the recent pressure on capital markets increase
the possibility of and may exacerbate the impact of any adverse effects on our financial position
and business prospects. Continued economic adversity may lead to or accelerate a decrease in the
trading price of our common stock and make it more difficult for us to raise capital, enter into
collaborations or maintain our compliance with the minimum listing standards of the NYSE Amex stock
exchange.
   14




---



##### Table of Contents



If
we are unable to successfully implement our cash preservation efforts, our business could be
materially adversely affected.
  We are currently not in compliance with NYSE Amex rules regarding the minimum shareholders
equity requirement and are at risk of being delisted from the NYSE Amex stock exchange, which may
subject us to the SECs penny stock rules and decrease the liquidity of our common stock. If our
common stock is delisted, this would likely make capital raising efforts more difficult.
      15




---



##### Table of Contents



In addition to our current operational requirements, we will need substantial additional
capital to develop our product candidates and for our future operations. If we are unable to obtain
such funds when needed, we may have to delay, scale back or terminate our product development
efforts or our business.
  
    
    the scope of our clinical trials, which is significantly influenced by the quality
of clinical data achieved as trials are completed and the requirements established by
regulatory authorities;
 
    
    the speed with which we complete our clinical trials, which depends on our ability
to attract and enroll qualifying patients and the quality of the work performed by our
clinical investigators;
 
    
    the time required to prosecute, enforce and defend our intellectual property rights,
which depends on evolving legal regimes and infringement claims that may arise between
us and third parties;
 
    
    the ability to manufacture at scales sufficient to supply commercial quantities of
any of our product candidates that receive regulatory approval, which may require
levels of effort not currently anticipated; and
 
    
    the successful commercialization of our product candidates, which will depend on our
ability to either create or partner with an effective commercialization organization
and which could be delayed or prevented by the emergence of equal or more effective
therapies.
   16




---



##### Table of Contents



Risks Related to Our Business and Operations
 Our business prospects are difficult to evaluate because we are developing complex and novel
medical product candidates.
  
    
    limited financial resources;
 
    
    developing novel, commercial-grade drug substances;
 
    
    testing and evaluating a new chemical entity and its effects in highly-complex
biological systems;
 
    
    marketing new products for which a market is not yet established and may never
become established;
 
    
    challenges related to the approval and acceptance of drug candidates by United
States federal and international regulatory authorities;
 
    
    delays inherent in the execution of clinical trials;
 
    
    high product development costs that result from all of these factors;
 
    
    competition from other therapies and drug candidates promoted by entities with
significantly more capital resources and marketing expertise than us; and
 
    
    difficulty recruiting qualified employees for management and other positions.
   17




---



##### Table of Contents



We may not successfully establish and maintain development and testing relationships with
third party service providers and collaborators, which could adversely affect our ability to
develop our product candidates.
 b b
  
    
    we do not achieve our objectives under our collaboration agreements;
 
    
    we or our collaborators are unable to obtain patent protection for the products or
proprietary technologies we develop in our collaborations;
 
    
    we are unable to manage multiple simultaneous product development collaborations;
 
    
    our collaborators become competitors of ours or enter into agreements with our
competitors;
 
    
    we or our collaborators encounter regulatory hurdles that prevent commercialization
of our product candidates; or
 
    
    we develop products and processes or enter into additional collaborations that
conflict with the business objectives of our other collaborators.
   18




---



##### Table of Contents



We are subject to intense government regulation and we may not receive regulatory approvals
for our new drug candidates.
   
    
    the FDA or other health regulatory authorities, or IRBs, do not approve a clinical
trial protocol or place a clinical trial on hold;
 
    
    suitable patients do not enroll in a clinical trial in sufficient numbers or at the
expected rate, or data is adversely affected by trial conduct or patient drop out;
 
    
    patients experience serious adverse events, including adverse side effects of our
drug candidates, for a variety of reasons that may or may not be related to our product
candidates, including the advanced stage of their disease and other medical problems;
 
    
    patients in the placebo or untreated control group exhibit greater than expected
improvements or fewer than expected adverse events;
 
    
    third-party clinical investigators do not perform the clinical trials on the
anticipated schedule or consistent with the clinical trial protocol and good clinical
practices, or other third-party organizations do not perform data collection and
analysis in a timely or accurate manner;
 
    
    service providers, collaborators or co-sponsors do not adequately perform their
obligations in relation to the clinical trial or cause the trial to be delayed or
terminated;
 
    
    regulatory inspections of manufacturing facilities, which may, among other things,
require us or a co-sponsor to undertake corrective action or suspend the clinical
trials;
 
    
    the interim results of the clinical trial are inconclusive or negative;
 
    
    the clinical trial, although approved and completed, generates data that is not
considered by the FDA or others to be sufficient to demonstrate safety and efficacy;
and
 
    
    changes in governmental regulations or administrative actions affect the conduct of
the clinical trial or the interpretation of its results.
   19




---



##### Table of Contents



Mauro Bove, a member of our Board, is also a director and officer of Sigma-Tau Finanziaria
S.p.A, which together with its affiliates comprise our largest stockholder group, a relationship
which could give rise to a conflict of interest involving Mr. Bove.
   We are heavily reliant on our license from the National Institutes of Health for the rights to
Tß4, and any loss of these rights would adversely affect our business.
  All of our drug candidates are based on a single compound that has yet to be proven effective
in human subjects.
 b b
  20




---



##### Table of Contents




    
    be found ineffective or cause harmful side effects during pre-clinical studies or
clinical trials;
 
    
    fail to receive necessary regulatory approvals;
 
    
    be precluded from commercialization by proprietary rights of third parties;
 
    
    be difficult to manufacture on a large scale; or
 
    
    be uneconomical or otherwise fail to achieve market acceptance.
 b
 We have no manufacturing or formulation capabilities and are dependent upon third-party
suppliers to provide us with our product candidates. If these suppliers do not manufacture our
product candidates in sufficient quantities, at acceptable quality levels and at acceptable cost,
or if we are unable to identify suitable replacement suppliers if needed, our clinical development
efforts could be delayed, prevented or impaired.
 b b b
  
    
    Their respective abilities to ensure quality and compliance with regulations
relating to the manufacture of pharmaceuticals;
 
    
    Their manufacturing capacity may not be sufficient or available to produce the
required quantities of our product candidates based on our planned clinical development
schedule, if at all;
 
    
    They may not have access to the capital necessary to expand their manufacturing
facilities in response to our needs;
 
    
    Commissioning replacement suppliers would be difficult and time-consuming;
 
    
    Individual suppliers may have used substantial proprietary know-how relating to the
manufacture of our product candidates and, in the event we must find a replacement or
supplemental supplier, our ability to transfer this know-how to the new supplier could
be an expensive and/or time-consuming process;
 
    
    An individual supplier may experience events, such as a fire or natural disaster,
that force it to stop or curtail production for an extended period;
 
    
    An individual supplier could encounter significant increases in labor, capital or
other costs that would make it difficult for them to produce our products
cost-effectively; or
 
    
    An individual supplier may not be able to obtain the raw materials or validated drug
containers in sufficient quantities, at acceptable costs or in sufficient time to
complete the manufacture, formulation and delivery of our product candidates.
  21




---



##### Table of Contents



If any of our key employees discontinue their services with us, our efforts to develop our
business may be delayed.
  We are subject to intense competition from companies with greater resources and more mature
products, which may result in our competitors developing or commercializing products before or more
successfully than we do.
    22




---



##### Table of Contents



We face the risk of product liability claims, which could adversely affect our business and
financial condition.
  b
 Governmental and third-party payers may subject any product candidates we develop to sales and
pharmaceutical pricing controls that could limit our product revenues and delay profitability.
  Clinical trials could be delayed or fail to show efficacy, resulting in additional cost or
failure to commercialize our technology platform.
   23




---



##### Table of Contents



b
   We have no marketing experience, sales force or distribution capabilities. If our product
candidates are approved, and we are unable to recruit key personnel to perform these functions, we
may not be able to commercialize them successfully.
   24




---



##### Table of Contents



Even if approved for marketing, our technologies and product candidates are unproven and they
may fail to gain market acceptance.
 b
 
    
    the timing and receipt of marketing approvals;
 
    
    the safety and efficacy of the products;
 
    
    the emergence of equivalent or superior products;
 
    
    the cost-effectiveness of the products; and
 
    
    ineffective marketing.
  Our technologies and product candidates may have unacceptable side effects that could delay or
prevent product approval.
  Our suppliers may use hazardous and biological materials in their businesses. Any claims
relating to improper handling, storage or disposal of these materials could be time-consuming and
costly to us, and we are not insured against such claims.
   25




---



##### Table of Contents



If we enter markets outside the United States our business will be subject to political,
economic, legal and social risks in those markets, which could adversely affect our business.
  
    
    changes and limits in import and export controls;
 
    
    increases in custom duties and tariffs;
 
    
    changes in currency exchange rates;
 
    
    economic and political instability;
 
    
    changes in government regulations and laws;
 
    
    absence in some jurisdictions of effective laws to protect our intellectual property
rights; and
 
    
    currency transfer and other restrictions and regulations that may limit our ability
to sell certain product candidates or repatriate profits to the United States.
   26




---



##### Table of Contents



Risks Related To Our Intellectual Property
 If we are not able to maintain adequate patent protection for our product candidates, we may
be unable to prevent our competitors from using our technology or technology that we license.
 b b b
    27




---



##### Table of Contents



Changes to U.S. patent laws could materially reduce any value our patent portfolio may have.
  We may not have adequate protection for our unpatented proprietary information, which could
adversely affect our competitive position.
  We may be subject to claims that we or our employees have wrongfully used or disclosed alleged
trade secrets of former employers.
   28




---



##### Table of Contents



Risks Related To Our Common Stock
 Our common stock price is volatile, our stock is highly illiquid, and any investment in our
stock could decline substantially in value.
  
    
    results of pre-clinical studies and clinical trials;
 
    
    commercial success of approved products;
 
    
    corporate partnerships;
 
    
    technological innovations by us or competitors;
 
    
    changes in laws and government regulations both in the U.S. and overseas;
 
    
    changes in key personnel at our company;
 
    
    developments concerning proprietary rights, including patents and litigation
matters;
 
    
    public perception relating to the commercial value or safety of any of our product
candidates;
 
    
    future sales of our common stock;
 
    
    future issuance of our common stock causing dilution;
 
    
    anticipated or unanticipated changes in our financial performance;
 
    
    general trends related to the biopharmaceutical and biotechnological industries; and
 
    
    general conditions in the stock market.
  We have never paid dividends on our common stock.
   29




---



##### Table of Contents



Our principal stockholders have significant voting power and may take actions that may not be
in the best interests of our other stockholders.
  Our rights to repurchase certain shares of stock held by Sigma-Tau expire over time, and we
may never be able or elect to exercise these rights.
  A sale of a substantial number of shares of our common stock, or the perception that such
sales will occur, may cause the price of our common stock to decline.
  The exercise of options and warrants and other issuances of shares of common stock or
securities convertible into common stock will dilute your interest.
   30




---



##### Table of Contents



Our certificate of incorporation, our stockholder rights plan and Delaware law contain
provisions that could discourage or prevent a takeover or other change in control, even if such a
transaction would be beneficial to our stockholders, which could affect our stock price adversely
and prevent attempts by our stockholders to replace or remove our current management.
  We may become involved in securities class action litigation that could divert managements
attention and harm our business and our insurance coverage may not be sufficient to cover all costs
and damages.
   31




---



##### Table of Contents



Item 1B. Unresolved Staff Comments.
  
 
 Item 2. Properties.
  
 
 Item 3. Legal Proceedings.
  
 
 Item 4. Submission of Matters to a Vote of Security Holders.
 
  32




---



##### Table of Contents



PART II
 
 
 Item 5.
    
    Market for Registrants Common Equity, Related Stockholder Matters and Issuer Purchases of Securities.
   2008
    
    
    2007High
    
    
    Low
    
    
    High
    
    
    LowFirst Quarter
    
    $
    1.10
    
    
    $
    0.80
    
    
    $
    2.41
    
    
    $
    2.06Second Quarter
    
    $
    1.92
    
    
    $
    0.83
    
    
    $
    2.75
    
    
    $
    2.00Third Quarter
    
    $
    1.43
    
    
    $
    1.02
    
    
    $
    2.18
    
    
    $
    1.57Fourth Quarter
    
    $
    1.66
    
    
    $
    0.85
    
    
    $
    1.75
    
    
    $
    1.00
   
 
 Item 6. Selected Financial Data.
   33




---



##### Table of Contents



Item 7. Managements Discussion and Analysis of Financial Condition and Results of Operation.
 You should read the following discussion and analysis together with our consolidated financial
statements and the related notes included elsewhere in this annual report.
 Overview
 b b b
       34




---



##### Table of Contents



b
 b b b
    35




---



##### Table of Contents



Critical
Accounting Policies
  
    
    Share-based payment. Effective January 1, 2006, we adopted the fair value
recognition provisions of Statement of Financial Accounting Standards (SFAS) No. 123R
(FAS 123R), using the modified-prospective transition method, and therefore have not
restated results for prior periods. Under this method we recognize compensation expense for
all share-based payments granted to employees after January 1, 2006 and prior to but not
yet vested as of January 1, 2006, in accordance with FAS 123R. Under the fair value
recognition provisions of FAS 123R, we recognize stock-based compensation net of an
estimated forfeiture rate and only recognize compensation cost for those shares expected to
vest on a straight-line basis over the requisite service period of the award. Prior to
adopting FAS 123R, we accounted for share-based payments to employees under Accounting
Principles Board Opinion No. 25, Accounting for Stock Issued to Employees (APB 25) and
accordingly, we generally recognized compensation expense only when we granted options with
a discounted exercise price.
  
    
    Costs of pre-clinical studies and clinical trials. We accrue estimated costs
for pre-clinical studies and clinical trials conducted by contract research organizations
and participating hospitals. These costs are a significant component of research and
development expenses. We accrue costs for pre-clinical studies and clinical trials
performed by contract research organizations based on estimates of work performed under the
contracts. Costs of setting up hospital sites for participation in trials are accrued
immediately. Hospital costs related to patient enrollment are accrued as patients are
entered in the trial.
 Recent Accounting Pronouncements
   36




---



##### Table of Contents



Results of Operations
 Comparison of years ended December 31, 2008 and 2007
 Revenues
 Expenses
 Research and development b
  Expenses
 General and administrative
  37




---



##### Table of Contents



Liquidity and Capital Resources
  Cash Flows
 Net Cash Used in Operating Activities.
 Net Cash Provided by (Used in) Investing Activities.
 Net Cash Provided by Financing Activities.
 Future Funding Requirements
    38




---



##### Table of Contents




    
    the progress of our clinical trials,
 
    
    the progress of our research activities,
 
    
    the number and scope of our research programs,
 
    
    the progress of our pre-clinical development activities,
 
    
    the costs involved in preparing, filing, prosecuting, maintaining, enforcing and
defending patent and other intellectual property claims,
 
    
    the costs related to development and manufacture of pre-clinical, clinical and
validation lots for regulatory purposes and commercialization of drug supply
associated with our product candidates,
 
    
    our ability to enter into corporate collaborations and the terms and success of
these collaborations,
 
    
    the costs and timing of regulatory approvals, and
 
    
    the costs of establishing manufacturing, sales and distribution capabilities.
  
    
    the number of patients that ultimately participate in the trial,
 
    
    the duration of patient follow-up that seems appropriate in view of the results,
 
    
    the number of clinical sites included in the trials, and
 
    
    the length of time required to enroll suitable patient subjects.
      39




---



##### Table of Contents



Sources of Liquidity
  b
    Off Balance Sheet Arrangements
   40




---



##### Table of Contents



Item 7A. Quantitative and Qualitative Disclosures About Market Risk.
  
 
 Item 8. Financial Statements and Supplementary Data.
  
 
 Item 9. Changes in and Disagreements With Accountants on Accounting and Financial Disclosure.
  
 
 Item 9A(T). Controls and Procedures.
    41




---



##### Table of Contents



Managements Annual Report on Internal Control over Financial Reporting
    Internal
ControlIntegrated Framework
  Changes in Internal Control over Financial Reporting
  
 
 Item 9B. Other Information.
   42




---



##### Table of Contents



PART III
 
 
 Item 10. Directors, Executive Officers and Corporate Governance.
  
 
 Item 11. Executive Compensation.
  
 
 Item 12. Security Ownership of Certain Beneficial Owners and Management and Related Stockholder
Matters.
  
 
 Item 13. Certain Relationships and Related Transactions, and Director Independence.
  
 
 Item 14. Principal Accounting Fees and Services.
   43




---



##### Table of Contents



PART IV
 
 
 Item 15. Exhibits, Financial Statement Schedules.
 Exhibit No.
    
    Description of Exhibit
    
    Reference*3.1
    
    
    Restated Certificate of Incorporation
    
    Exhibit 3.1 to
Amendment No. 1 to
Registration
Statement (File No.
33-9370) (filed
November 26, 1986)3.2
    
    
    Certificate of Amendment
    
    Exhibit 3.2 to the
Companys
Transitional Report
on Form 10-K (File
No. 1-15070) (filed
March 18, 1991)3.3
    
    
    Certificate of Amendment
    
    Exhibit 3.3 to the
Companys Annual
Report on Form
10-KSB (File No.
1-15070) (filed
April 2, 2001)3.4
    
    
    Certificate of Designation of
Series A Participating Cumulative
Preferred Stock
    
    Exhibit 2 to the
Companys Current
Report on Form 10-K
(File No. 1-15070)
(filed May 2, 1994)3.5
    
    
    Amended and Restated Bylaws of the
Company
    
    Exhibit 3.4 to the
Companys Quarterly
Report on Form 10-Q
(filed August 14,
2006)3.6
    
    
    Amendment to Amended and Restated
Bylaws of the Company
    
    Exhibit 3.6 to the
Companys
Registration
Statement on Form
S-8 (File No.
333-152250) (filed
July 10, 2008)4.1
    
    
    Form of Stock Certificate
    
    Exhibit 4.1 to
Amendment No. 1 to
Registration
Statement (File
No. 33-9370) (filed
November 26, 1986)4.2
    
    
    Form of Rights Certificate
    
    Exhibit 3 to the
Companys Current
Report on Form 8-K
(File No. 1-15070)
(filed May 2, 1994)4.3
    
    
    Rights Agreement, dated April 29,
1994, between the Company and
American Stock Transfer & Trust
Company, as Rights Agent
    
    Exhibit 1 to the
Companys Current
Report on Form 8-K
(File No. 1-15070)
(filed May 2, 1994)4.4
    
    
    Amendment No. 1 to Rights Agreement,
dated March 4, 2004, between the
Company and American Stock
Transfer & Trust Company, as Rights
Agent
    
    Exhibit 4.3 to the
Companys Annual
Report on
Form 10-KSB (filed
March 31, 2006)
  44




---



##### Table of Contents



Exhibit No.
    
    Description of Exhibit
    
    Reference*10.1
    ^
    
    Amended and Restated 2000 Stock
Option and Incentive Plan, as
amended
    
    Annex A to the Companys
Proxy Statement on
Schedule 14A (filed May
9, 2008)10.2
    
    
    Patent License Agreement 
Exclusive, dated January 24, 2001,
between the Company and the U.S.
Public Health Service
    
    Exhibit 10.1 to the
Companys Annual Report
on Form 10-KSB (File No.
1-15070) (filed April 2,
2001)**10.3
    
    
    Thymosin Beta 4 License and Supply
Agreement, dated January 21, 2004,
between the Company and Defiante
Farmaceutica LDA
    
    Exhibit 10.10 to the
Companys Registration
Statement on Form SB-2
(File No. 333-113417)
(filed March 9, 2004)**10.4
    ^
    
    Second Amended and Restated
Employment Agreement, dated March
11, 2009, between the Company and
Allan L. Goldstein, as amended
    
    Filed herewith10.5
    ^
    
    Second Amended and Restated
Employment Agreement, dated March
12, 2009, between the Company and
J.J. Finkelstein, as amended
    
    Filed herewith10.6
    ^
    
    Second Amended and Restated
Employment Agreement, dated March
31, 2009, between the Company and C.
Neil Lyons, as amended
    
    Filed herewith10.7
    ^
    
    Second Amended and Restated
Employment Agreement, dated March
31, 2009, between the Company and
David Crockford
    
    Filed herewith10.8
    
    
    Form of Warrant to Purchase Common
Stock
    
    Exhibit 4.1 to the
Companys Current Report
on Form 8-K (filed on
January 6, 2005)10.9
    
    
    Form of Amendment to Warrant to
Purchase Common Stock
    
    Exhibit 99.1 to the
Companys Current Report
on Form 8-K (filed
January 7, 2008)10.10
    
    
    Form of Second Amendment to Warrant
to Purchase Common Stock
    
    Exhibit 99.1 to the
Companys Current Report
on Form 8-K (filed April
4, 2008)10.11
    
    
    Stock Purchase Agreement, dated June
23, 2005
    
    Exhibit 99.2 to the
Companys Current Report
on Form 8-K (filed June
23, 2005)
  45




---



##### Table of Contents



Exhibit No.
    
    Description of Exhibit
    
    Reference*10.12
    
    
    Form of Warrant to Purchase Common
Stock
    
    Exhibit 4.1 to the
Companys Current Report
on Form 8-K (filed March
7, 2006)10.13
    
    
    Registration Rights Agreement, dated
December 15, 2006
    
    Exhibit 10.2 to the
Companys Current Report
on Form 8-K (filed on
December 18, 2006)10.14
    
    
    Form of Warrant to Purchase Common
Stock
    
    Exhibit 4.1 to the
Companys Current Report
on Form 8-K (filed on
December 18, 2006)10.15
    
    
    Form of Securities Purchase Agreement
    
    Exhibit 99.1 to the
Companys Current Report
on Form 8-K (filed
February 27, 2008)10.16
    
    
    Form of Warrant to Purchase Common
Stock
    
    Exhibit 4.1 to the
Companys Current Report
on Form 8-K (filed
February 27, 2008)10.17
    
    
    Form of Securities Purchase
Agreement, dated December 10, 2008
    
    Exhibit 99.1 to the
Companys Current Report
on Form 8-K (filed on
December 12, 2008)10.18
    
    
    Form of Warrant to Purchase Common
Stock
    
    Exhibit 4.1 to the
Companys Current Report
on Form 8-K (filed
December 12, 2008)
  46




---



##### Table of Contents



Exhibit No.
    
    Description of Exhibit
    
    Reference*23.1
    
    
    Consent of Reznick Group, P.C.
    
    Filed herewith24.1
    
    
    Powers of Attorney
    
    Included on signature page31.1
    
    
    Certification of Principal Executive
Officer pursuant to Rules 13a-14 and
15d-14 promulgated under the
Securities Exchange Act of 1934
    
    Filed herewith31.2
    
    
    Certification of Principal
Financial Officer pursuant to Rules 13a-14 and
15d-14 promulgated under the
Securities Exchange Act of 1934
    
    Filed herewith32.1
    
    
    Certification of Principal Executive
Officer pursuant to 18 U.S.C.
Section 1350, as adopted pursuant to
Section 906 of the Sarbanes-Oxley
Act of 2002
    
    Filed herewith***32.2
    
    
    Certification of Principal Financial
Officer pursuant to 18 U.S.C.
Section 1350, as adopted pursuant to
Section 906 of the Sarbanes-Oxley
Act of 2002
    
    Filed herewith***
 
 *
    
    Except where noted, the exhibits referred to in this column have
heretofore been filed with the Securities and Exchange Commission as
exhibits to the documents indicated and are hereby incorporated by
reference thereto. The Registration Statements referred to are
Registration Statements of the Company.**
    
    The registrant has been granted confidential treatment with respect to
certain portions of this exhibit (indicated by asterisks), which have
been filed separately with the Securities and Exchange Commission.***
    
    These certifications are being furnished solely to accompany this
annual report pursuant to 18 U.S.C. Section 1350, and are not being
filed for purposes of Section 18 of the Securities Exchange Act of
1934 and are not to be incorporated by reference into any filing of
the registrant, whether made before or after the date hereof,
regardless of any general incorporation language in such filing.^
    
    Compensatory plan, contract or arrangement.  47




---



##### Table of Contents



SIGNATURES
  RegeneRx Biopharmaceuticals,
Inc.
(Registrant)Date:  April 15, 2009
    By:

/s/
J.J. FinkelsteinJ.J. FinkelsteinPresident and Chief Executive OfficerBy:

/s/ C. Neil LyonsC. Neil LyonsChief Financial Officer  48




---



##### Table of Contents



POWER OF ATTORNEY
   Name
    
    Title
    
    Date/s/ Allan L. Goldstein

Allan L. Goldstein
    
    Chairman of the Board, Chief
Scientific Advisor, and Director
    
    April 15, 2009/s/ J.J. Finkelstein

J.J. Finkelstein
    
    President, Chief Executive
Officer, and Director (Principal
Executive Officer)
    
    April 15, 2009/s/ C. Neil Lyons

C. Neil Lyons
    
    Chief Financial Officer and
Treasurer (Principal Financial
Officer and Principal Accounting
Officer)
    
    April 15, 2009/s/ Richard J. Hindin

Richard J. Hindin
    
    Director
    
    April 15, 2009/s/ Joseph C. McNay

Joseph C. McNay
    
    Director
    
    April 15, 2009Mauro Bove
    
    Director/s/ L. Thompson Bowles

L. Thompson Bowles
    
    Director
    
    April 15, 2009
  49




---



##### Table of Contents



RegeneRx Biopharmaceuticals, Inc.
Index to Financial Statements
 PageReport of Independent Registered Public Accounting Firm
    
    
    F-2Balance Sheets
    
    

   F-3Statements of Operations
    
    

  F-4Statements
of Changes in Stockholders Equity
    
    
  F-5Statements of Cash Flows
    
    
  F-6Notes to Financial Statements
    
    
  F-7
  F-1




---



##### Table of Contents



REPORT OF INDEPENDENT REGISTERED PUBLIC ACCOUNTING FIRM
 
     
  F-2




---



##### Table of Contents



RegeneRx Biopharmaceuticals, Inc.
 
 Balance Sheets
 December 31,
    
    
    December 31,2008
    
    
    2007ASSETSCurrent assetsCash and cash equivalents
    
    $
    5,655,367
    
    
    $
    3,696,878Short-term investments
    
    
    
    
    
    
    4,579,592Accounts receivable
    
    
    
    
    
    
    26,951Prepaid expenses and other current assets
    
    
    236,477
    
    
    
    268,244Total current assets
    
    
    5,891,844
    
    
    
    8,571,665Property and equipment, net of accumulated
depreciation of $81,623 and $62,227
    
    
    25,039
    
    
    
    44,435Other assets
    
    
    5,693
    
    
    
    5,693Total assets
    
    $
    5,922,576
    
    
    $
    8,621,793LIABILITIES AND STOCKHOLDERS EQUITYCurrent liabilitiesAccounts payable
    
    $
    70,554
    
    
    $
    273,561Accrued expenses
    
    
    1,255,358
    
    
    
    2,195,508Total current liabilities
    
    
    1,325,912
    
    
    
    2,469,069Commitments
    
    
    
    
    
    
    Stockholders equityPreferred stock, $.001 par value per
share, 1,000,000 shares authorized; no
shares issued
    
    
    
    
    
    
    Common stock, $.001 par value per share,
100,000,000 shares authorized; 53,622,491
and 46,553,527 issued and outstanding
    
    
    53,623
    
    
    
    46,554Additional paid-in capital
    
    
    82,550,585
    
    
    
    73,513,292Accumulated other comprehensive loss
    
    
    
    
    
    
    (1,543
    )Accumulated deficit
    
    
    (78,007,544
    )
    
    
    (67,405,579
    )Total stockholders equity
    
    
    4,596,664
    
    
    
    6,152,724Total liabilities and stockholders equity
    
    $
    5,922,576
    
    
    $
    8,621,793
   F-3




---



##### Table of Contents



RegeneRx Biopharmaceuticals, Inc.
 
 Statements of Operations
 Years ended December 31,2008
    
    
    2007Sponsored research revenue
    
    $
    168,412
    
    
    $
    240,324Operating expensesResearch and development
    
    
    7,109,808
    
    
    
    8,887,255General and administrative
    
    
    3,845,346
    
    
    
    3,197,685Total operating expenses
    
    
    10,955,154
    
    
    
    12,084,940Loss from operations
    
    
    (10,786,742
    )
    
    
    (11,844,616
    )Interest income
    
    
    149,777
    
    
    
    666,458Net loss
    
    $
    (10,636,965
    )
    
    $
    (11,178,158
    )Basic and diluted net loss per common share
    
    $
    (0.21
    )
    
    $
    (0.24
    )Weighted average number of common shares outstanding
    
    
    50,967,617
    
    
    
    46,465,982
   F-4




---



##### Table of Contents



RegeneRx Biopharmaceuticals, Inc.
 
 Statements of Changes in Stockholders Equity
 Years ended December 31, 2008 and 2007
 Accumulatedother
    
    
    TotalCommon stock
    
    
    Additional
    
    
    Accumulated
    
    
    Comprehensive
    
    
    stockholdersShares
    
    
    Amount
    
    
    Paid-in capital
    
    
    Deficit
    
    
    Income/(loss)
    
    
    equityBalance, December 31, 2006
    
    
    46,096,477
    
    
    $
    46,096
    
    
    $
    72,433,660
    
    
    $
    (56,227,421
    )
    
    $
    
    
    
    $
    16,252,335Issuance of common stock upon exercise of warrants
    
    
    457,050
    
    
    
    458
    
    
    
    45,248
    
    
    
    
    
    
    
    
    
    
    
    45,706Share-based compensation expense
    
    
    
    
    
    
    
    
    
    
    1,034,384
    
    
    
    
    
    
    
    
    
    
    
    1,034,384Net loss
    
    
    
    
    
    
    
    
    
    
    
    
    
    
    (11,178,158
    )
    
    
    
    
    
    
    (11,178,158
    )Unrealized loss on available for sale securities
    
    
    
    
    
    
    
    
    
    
    
    
    
    
    
    
    
    
    (1,543
    )
    
    
    (1,543
    )Total comprehensive loss
    
    
    
    
    
    
    
    
    
    
    
    
    
    
    
    
    
    
    
    
    
    
    (11,179,701
    )Balance, December 31, 2007
    
    
    46,553,527
    
    
    
    46,554
    
    
    
    73,513,292
    
    
    
    (67,405,579
    )
    
    
    (1,543
    )
    
    
    6,152,724Cumulative effect of a change in 
accounting principle 
EITF
07-03
    
    
    
    
    
    
    
    
    
    
    
    
    
    
    35,000
    
    
    
    
    
    
    
    35,000Issuance of common stock, net of offering costs of $52,240
    
    
    7,068,964
    
    
    
    7,069
    
    
    
    7,940,691
    
    
    
    
    
    
    
    
    
    
    
    7,947,760Share-based compensation expense
    
    
    
    
    
    
    
    
    
    
    1,096,602
    
    
    
    
    
    
    
    
    
    
    
    1,096,602Net loss
    
    
    
    
    
    
    
    
    
    
    
    
    
    
    (10,636,965
    )
    
    
    
    
    
    
    (10,636,965
    )Unrealized gain on available for sale securities
    
    
    
    
    
    
    
    
    
    
    
    
    
    
    
    
    
    
    1,543
    
    
    
    1,543Total comprehensive loss
    
    
    
    
    
    
    
    
    
    
    
    
    
    
    
    
    
    
    
    
    
    
    (10,635,422
    )Balance, December 31, 2008
    
    
    53,622,491
    
    
    $
    53,623
    
    
    $
    82,550,585
    
    
    $
    (78,007,544
    )
    
    $
    
    
    
    $
    4,596,664
   F-5




---



##### Table of Contents



RegeneRx Biopharmaceuticals, Inc.
 
 Statements of Cash Flows
 For the Year ended December 31,2008
    
    
    2007Operating activities:Net loss
    
    $
    (10,636,965
    )
    
    $
    (11,178,158
    )Adjustments to reconcile net loss to net cash used
in operating activities:Depreciation and amortization
    
    
    19,396
    
    
    
    21,197Non-cash share-based compensation
    
    
    1,096,602
    
    
    
    1,034,384Changes in operating assets and liabilities:Accounts receivable
    
    
    26,951
    
    
    
    245,540Prepaid expenses and other current assets
    
    
    66,767
    
    
    
    (156,565
    )Other assets
    
    
    
    
    
    
    6,056Accounts payable
    
    
    (203,007
    )
    
    
    (88,841
    )Accrued expenses
    
    
    (940,150
    )
    
    
    1,308,620Net cash used in operating activities
    
    
    (10,570,406
    )
    
    
    (8,807,767
    )Investing activities:Purchase of short-term investments
    
    
    
    
    
    
    (20,681,135
    )Sales/maturities of short-term investments
    
    
    4,581,135
    
    
    
    20,100,000Purchase of property and equipment
    
    
    
    
    
    
    (12,234
    )Net cash provided by (used in) investing activities
    
    
    4,581,135
    
    
    
    (593,369
    )Financing activities:Net proceeds from issuance of common stock
    
    
    7,947,760
    
    
    
    Proceeds from exercise of warrants
    
    
    
    
    
    
    45,706Net cash provided by financing activities
    
    
    7,947,760
    
    
    
    45,706Net increase (decrease) in cash and cash equivalents
    
    
    1,958,489
    
    
    
    (9,355,430
    )Cash and cash equivalents at beginning of year
    
    
    3,696,878
    
    
    
    13,052,308Cash and cash equivalents at end of year
    
    $
    5,655,367
    
    
    $
    3,696,878
   F-6




---



##### Table of Contents



1.
    
    ORGANIZATION AND BUSINESS
 Organization and Nature of Operations. b
 Management Plans to Address Operating Conditions.
 Tb4-based
  b
  F-7




---



##### Table of Contents



2.
    
    SUMMARY OF SIGNIFICANT ACCOUNTING POLICIES
 Use of Estimates.
 Cash and Cash Equivalents.
 Short-term Investments.
 Concentration of Credit Risk.
 Property and Equipment.
 Impairment of Long-lived Assets.
 Sponsored Research Revenues.
  F-8




---



##### Table of Contents



Research and Development b b b
 Patent Costs.
 Income Taxes.
   Net Loss Per Common Share.
  F-9




---



##### Table of Contents



Share-Based Compensation.
  Pronouncements Implemented.
 Pronouncements Not Yet Implemented.
 3.
    
    FAIR VALUE MEASUREMENTS
  
    
    Level 1  Quoted prices in active markets for identical assets and liabilities.
 
    
    Level 2  Observable inputs other than quoted prices in active markets
for identical assets and liabilities.
 
    
    Level 3  Unobservable inputs.
  F-10




---



##### Table of Contents



4.
    
    LICENSES, INTELLECTUAL PROPERTY, AND RELATED PARTY TRANSACTIONS
 b b
 b b
   F-11




---



##### Table of Contents



5.
    
    COMPOSITION OF CERTAIN FINANCIAL STATEMENT CAPTIONS
  December 31,2008
    
    
    2007Accrued clinical research
    
    $
    944,283
    
    
    $
    1,915,132Accrued professional fees
    
    
    155,000
    
    
    
    148,962Accrued compensation
    
    
    84,361
    
    
    
    83,002Accrued vacation
    
    
    61,714
    
    
    
    43,745Other
    
    
    10,000
    
    
    
    4,667$
    1,255,358
    
    
    $
    2,195,508
 6.
    
    EMPLOYEE BENEFIT PLANS
  7.
    
    STOCKHOLDERS EQUITY
 Shareholders Rights Plan.
 Registration Rights Agreements.
  Common Stock.
  F-12




---



##### Table of Contents



Share-Based Compensation.
 2000 Stock Option and Incentive Plan, as amended.
  F-13




---



##### Table of Contents



Options outstandingWeightedShares
    
    
    
    
    
    
    
    
    
    
    averageavailable for
    
    
    Number of
    
    
    Exercise price
    
    
    exercisegrant
    
    
    shares
    
    
    range
    
    
    priceDecember 31, 2006
    
    
    1,480,000
    
    
    
    2,685,000
    
    
    $
    0.28  $3.82
    
    
    $
    1.66Grants
    
    
    (860,000
    )
    
    
    860,000
    
    
    
    1.93    2.34
    
    
    
    2.24Exercises
    
    
    
    
    
    
    
    
    
    
    
    
    
    
    Cancellations
    
    
    
    
    
    
    
    
    
    
    
    
    
    
    December 31, 2007
    
    
    620,000
    
    
    
    3,545,000
    
    
    
    0.28   3.82
    
    
    
    1.80Grants
    
    
    (572,500
    )
    
    
    572,500
    
    
    
    1.14    1.50
    
    
    
    1.23Exercises
    
    
    
    
    
    
    
    
    
    
    
    
    
    
    Cancellations
    
    
    
    
    
    
    
    
    
    
    
    
    
    
    Newly authorized
    
    
    2,300,000
    
    
    
    
    
    
    
    
    
    
    
    December 31, 2008
    
    
    2,347,500
    
    
    
    4,117,500
    
    
    $
    0.28  $3.82
    
    
    $
    1.72
  Outstanding options
    
    
    Exercisable optionsWeighted-
    
    
    
    
    
    
    
    
    
    
    Weighted-average
    
    
    Weighted-
    
    
    
    
    
    
    average
    
    
    Weighted-Number of
    
    
    remaining
    
    
    average
    
    
    Number of
    
    
    remaining
    
    
    averageshares
    
    
    contractual
    
    
    exercise
    
    
    shares
    
    
    contractual
    
    
    exerciseRange of exercise prices
    
    outstanding
    
    
    life (in years)
    
    
    price
    
    
    outstanding
    
    
    life (in years)
    
    
    price$0.28  $0.86
    
    
    1,290,000
    
    
    
    3.2
    
    
    $
    0.38
    
    
    
    1,252,500
    
    
    
    3.1
    
    
    $
    0.37$1.07  $1.93
    
    
    852,500
    
    
    
    6.3
    
    
    $
    1.32
    
    
    
    282,084
    
    
    
    5.2
    
    
    $
    1.50$2.02  $2.68
    
    
    900,000
    
    
    
    5.4
    
    
    $
    2.27
    
    
    
    174,000
    
    
    
    5.6
    
    
    $
    2.33$3.00  $3.82
    
    
    1,075,000
    
    
    
    6.4
    
    
    $
    3.19
    
    
    
    692,915
    
    
    
    6.4
    
    
    $
    3.194,117,500
    
    
    
    
    
    
    
    
    
    
    
    2,401,499Intrinsic value of
in-the-money options,
using the December 31,
2008 closing price of
$1.18
    
    $
    1,083,300
    
    
    
    
    
    
    
    
    
    
    $
    1,018,050
 Determining the Fair Value of Options.
 2008
    
    
    2007Dividend yield
    
    
    0.0%
    
    
    
    0.0%Risk free rate of return
    
    
    0.8  3.7%
    
    
    
    3.9  5.1%Expected life in years
    
    
    1.00  4.75
    
    
    
    3.0  5.0Volatility
    
    
    68-82%
    
    
    
    68-75%
  F-14




---



##### Table of Contents



Warrants to Purchase Common Stock.
  Warrants outstandingWeightedNumber of
    
    
    Exercise price
    
    
    averageexerciseshares
    
    
    range
    
    
    priceDecember 31, 2006
    
    
    3,979,594
    
    
    $
    0.10  $4.06
    
    
    $
    2.90Grants
    
    
    
    
    
    
    
    
    
    
    Exercises
    
    
    (457,050
    )
    
    
    0.10
    
    
    
    0.10Cancellations
    
    
    
    
    
    
    
    
    
    
    December 31, 2007
    
    
    3,522,544
    
    
    
    2.75  4.06
    
    
    
    3.26Grants
    
    
    1,745,104
    
    
    
    1.60  1.74
    
    
    
    1.66Exercises
    
    
    
    
    
    
    
    
    
    
    Cancellations
    
    
    (18,558
    )
    
    
    4.05  4.06
    
    
    
    4.05December 31, 2008
    
    
    5,249,090
    
    
    $
    1.60  $4.06
    
    
    $
    2.80
  F-15




---



##### Table of Contents



8.
    
    INCOME TAXES
  December 31,2008
    
    
    2007Deferred tax assets:Net operating loss carryforwards
    
    
    18,370,000
    
    
    
    20,491,000Research and development tax credit
carryforward
    
    
    1,628,000
    
    
    
    1,649,000Charitable contribution carryforward
    
    
    39,000
    
    
    
    42,000Accrued vacation
    
    
    12,000
    
    
    
    8,000Accrued expenses
    
    
    150,000
    
    
    
    93,000Amortization
    
    
    6,000
    
    
    
    6,000Other
    
    
    919,000
    
    
    
    677,00021,124,000
    
    
    
    22,966,000Less  valuation allowance
    
    
    (21,123,000
    )
    
    
    (22,963,000
    )Net deferred tax asset
    
    
    1,000
    
    
    
    3,000Deferred tax liabilities:Depreciation
    
    
    (1,000
    )
    
    
    (3,000
    )Net deferred tax amounts
    
    $
    
    
    
    $
    
     F-16




---



##### Table of Contents



December 31,2008
    
    
    2007Tax benefit at statutory rate
    
    $
    (3,617,000
    )
    
    $
    (3,800,000
    )State taxes
    
    
    (579,000
    )
    
    
    (516,000
    )Permanent M-1s
    
    
    563,000
    
    
    
    673,000Limited/expired net operating loss carryforwards
    
    
    6,150,000
    
    
    
    1,378,000Limited/expired research and development tax
credit carryforward
    
    
    284,000
    
    
    
    80,000Research and development tax credit carryforward
    
    
    (504,000
    )
    
    
    (695,000
    )Change in effective tax rate
    
    
    (455,000
    )
    
    
    Change in valuation allowance
    
    
    (1,842,000
    )
    
    
    2,880,000$
    
    
    
    $
    
  9.
    
    COMMITMENTS
 Lease
 Employment Continuity Agreements.
 10.
    
    SUBSEQUENT EVENT
   F-17




---



##### Table of Contents



EXHIBIT INDEX
 Exhibit No.
    
    Description of Exhibit
    
    Reference*3.1
    
    Restated Certificate of Incorporation
    
    Exhibit 3.1 to
Amendment No. 1 to
Registration
Statement (File No.
33-9370) (filed
November 26, 1986)3.2
    
    Certificate of Amendment
    
    Exhibit 3.2 to the
Companys
Transitional Report
on Form 10-K (File
No. 1-15070) (filed
March 18, 1991)3.3
    
    Certificate of Amendment
    
    Exhibit 3.3 to the
Companys Annual
Report on Form

10-KSB (File No.
1-15070) (filed
April 2, 2001)3.4
    
    Certificate of Designation of
Series A Participating Cumulative
Preferred Stock
    
    Exhibit 2 to the
Companys Current
Report on Form 10-K
(File No. 1-15070)
(filed May 2, 1994)3.5
    
    Amended and Restated Bylaws of the
Company
    
    Exhibit 3.4 to the
Companys Quarterly
Report on Form 
10-Q
(filed August 14,
2006)3.6
    
    Amendment to Amended and Restated
Bylaws of the Company
    
    Exhibit 3.6 to the
Companys
Registration
Statement on Form
S-8 (File No.
333-152250) (filed
July 10, 2008)4.1
    
    Form of Stock Certificate
    
    Exhibit 4.1 to
Amendment No. 1 to
Registration
Statement (File
No. 33-9370) (filed
November 26, 1986)4.2
    
    Form of Rights Certificate
    
    Exhibit 3 to the
Companys Current
Report on Form 8-K
(File No. 1-15070)
(filed May 2, 1994)4.3
    
    Rights Agreement, dated April 29,
1994, between the Company and
American Stock Transfer & Trust
Company, as Rights Agent
    
    Exhibit 1 to the
Companys Current
Report on Form 8-K
(File No. 1-15070)
(filed May 2, 1994)4.4
    
    Amendment No. 1 to Rights Agreement,
dated March 4, 2004, between the
Company and American Stock
Transfer & Trust Company, as Rights
Agent
    
    Exhibit 4.3 to the
Companys Annual
Report on
Form 

10-KSB (filed
March 31, 2006)




---



##### Table of Contents



Exhibit No.
    
    Description of Exhibit
    
    Reference*10.1^
    
    Amended and Restated 2000 Stock
Option and Incentive Plan, as
amended
    
    Annex A to the Companys
Proxy Statement on
Schedule 14A (filed May
9, 2008)10.2
    
    Patent License Agreement 
Exclusive, dated January 24, 2001,
between the Company and the U.S.
Public Health Service
    
    Exhibit 10.1 to the
Companys Annual Report
on Form 
10-KSB (File No.
1-15070) (filed April 2,
2001)**10.3
    
    Thymosin Beta 4 License and Supply
Agreement, dated January 21, 2004,
between the Company and Defiante
Farmaceutica LDA
    
    Exhibit 10.10 to the Companys Registration
Statement on Form SB-2
(File No. 333-113417)
(filed March 9, 2004)**10.4^
    
    Second Amended and Restated
Employment Agreement, dated March
11, 2009, between the Company and
Allan L. Goldstein, as amended
    
    Filed herewith10.5^
    
    Second Amended and Restated
Employment Agreement, dated March
12, 2009, between the Company and
J.J. Finkelstein, as amended
    
    Filed herewith10.6^
    
    Second Amended and Restated
Employment Agreement, dated March
31, 2009, between the Company and C.
Neil Lyons, as amended
    
    Filed herewith10.7^
    
    Second Amended and Restated
Employment Agreement, dated March
31, 2009, between the Company and
David Crockford
    
    Filed herewith10.8
    
    Form of Warrant to Purchase Common
Stock
    
    Exhibit 4.1 to the
Companys Current Report
on Form 8-K (filed on
January 6, 2005)10.9
    
    Form of Amendment to Warrant to
Purchase Common Stock
    
    Exhibit 99.1 to the
Companys Current Report
on Form  8-K (filed
January 7, 2008)10.10
    
    Form of Second Amendment to Warrant
to Purchase Common Stock
    
    Exhibit 99.1 to the
Companys Current Report
on Form 
8-K (filed April
4, 2008)10.11
    
    Stock Purchase Agreement, dated June
23, 2005
    
    Exhibit 99.2 to the
Companys Current Report
on Form 
8-K (filed June
23, 2005)




---



##### Table of Contents



Exhibit No.
    
    Description of Exhibit
    
    Reference*10.12
    
    Form of Warrant to Purchase Common Stock
    
    Exhibit 4.1 to the
Companys Current Report on Form 8-K (filed March 7, 2006)10.13
    
    Registration Rights Agreement, dated
December 15, 2006
    
    Exhibit 10.2 to the
Companys Current Report on Form 8-K (filed on December 18, 2006)10.14
    
    Form of Warrant to Purchase Common
Stock
    
    Exhibit 4.1 to the
Companys Current Report on Form 8-K (filed on December 18, 2006)10.15
    
    Form of Securities Purchase Agreement
    
    Exhibit 99.1 to the
Companys Current Report on Form 8-K (filed February 27, 2008)10.16
    
    Form of Warrant to Purchase Common
Stock
    
    Exhibit 4.1 to the
Companys Current Report on Form 8-K (filed February 27, 2008)10.17
    
    Form of Securities Purchase
Agreement, dated December 10, 2008
    
    Exhibit 99.1 to the
Companys Current Report on Form 8-K (filed on
December 12, 2008)10.18
    
    Form of Warrant to Purchase Common
Stock
    
    Exhibit 4.1 to the
Companys Current Report on Form 8-K (filed December 12, 2008)




---



##### Table of Contents



Exhibit No.
    
    Description of Exhibit
    
    Reference*23.1
    
    Consent of Reznick Group, P.C.
    
    Filed herewith24.1
    
    Powers of Attorney
    
    Included on signature page31.1
    
    Certification of Principal Executive
Officer pursuant to Rules 13a-14 and
15d-14 promulgated under the
Securities Exchange Act of 1934
    
    Filed herewith31.2
    
    Certification
of Principal Financial Officer pursuant to Rules 13a-14 and
15d-14 promulgated under the
Securities Exchange Act of 1934
    
    Filed herewith32.1
    
    Certification of Principal Executive
Officer pursuant to 18 U.S.C.
Section 1350, as adopted pursuant to
Section 906 of the Sarbanes-Oxley
Act of 2002
    
    Filed herewith***32.2
    
    Certification of Principal Financial
Officer pursuant to 18 U.S.C.
Section 1350, as adopted pursuant to
Section 906 of the Sarbanes-Oxley
Act of 2002
    
    Filed herewith***
 *
    
    Except where noted, the exhibits referred to in this column have heretofore been filed
with the Securities and Exchange Commission as exhibits to the documents indicated and
are hereby incorporated by reference thereto. The Registration Statements referred to are
Registration Statements of the Company.**
    
    The registrant has been granted confidential treatment with respect to certain portions
of this exhibit (indicated by asterisks), which have been filed separately with the
Securities and Exchange Commission.***
    
    These certifications are being furnished solely to accompany this annual report pursuant
to 18 U.S.C. Section 1350, and are not being filed for purposes of Section 18 of the
Securities Exchange Act of 1934 and are not to be incorporated by reference into any
filing of the registrant, whether made before or after the date hereof, regardless of any
general incorporation language in such filing.^
    
    Compensatory plan, contract or arrangement.