##### 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, 2009
 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
    
    52-1253406(State or other jurisdiction of
    
    (I.R.S. Employerincorporation or organization)
    
    Identification No.)15245 Shady Grove Road, Rockville, MD
    
    20850(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
 þ Yes o No
 o o
 þ
  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




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##### 



TABLE OF CONTENTS
 PART IItem 1. Business
    
    
    3Item 1A. Risk Factors
    
    
    11Item 1B. Unresolved Staff Comments
    
    
    24Item 2. Properties
    
    
    24Item 3. Legal Proceedings
    
    
    24Item 4. Reserved
    
    
    24PART IIItem 5. Market for Registrants Common Equity, Related Stockholder Matters and Issuer
Purchases of Securities
    
    
    25Item 6. Selected Financial Data
    
    
    25Item 7. Managements Discussion and Analysis of Financial Condition and Results of Operation
    
    
    25Item 7A. Quantitative and Qualitative Disclosures About Market Risk
    
    
    31Item 8. Financial Statements and Supplementary Data
    
    
    31Item 9. Changes in and Disagreements With Accountants on Accounting and Financial Disclosure
    
    
    31Item 9A(T). Controls and Procedures
    
    
    31Item 9B. Other Information
    
    
    32PART IIIItem 10. Directors, Executive Officers and Corporate Governance
    
    
    33Item 11. Executive Compensation
    
    
    35Item 12. Security Ownership of Certain Beneficial Owners and Management and Related
Stockholder Matters
    
    
    40Item 13. Certain Relationships and Related Transactions, and Director Independence
    
    
    41Item 14. Principal Accounting Fees and Services
    
    
    42PART IVItem 15. Exhibits, Financial Statement Schedules
    
    
    43SIGNATURES
    
    
    46INDEX TO FINANCIAL STATEMENTS
    
    
    F-1EXHIBIT INDEX
    
    
    48Exhibit 10.25Exhibit 23.1Exhibit 31.1Exhibit 31.2Exhibit 32.1Exhibit 32.2
   2




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##### 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 or capital resources, 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 chronic dermal wounds and reduction of scar tissue;
    
    RGN-259, a sterile, preservative-free topical eye drop for ophthalmic indications; and
    
    RGN-352, a parenteral (injectable) formulation for systemic delivery to treat
cardiovascular diseases, central nervous system diseases, and other medical indications
that require administration by injection. We are initially targeting RGN-352 for the
treatment of patients who have suffered an acute myocardial infarction (AMI) or heart
attack. Recent animal research suggests that this formulation may also prove efficacious
for patients with multiple sclerosis (MS) and stroke.
 b
    b b in vitro in
vitro
  3




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##### Table of Contents



Going Concern
  Mechanism of Action, Research Studies and Potential Commercial Applications
 b b b b
 Progenitor (stem) cell differentiation  Nature b Journal of Molecular and Cellular Cardiology b b Nature b Circulation b b Neuroscience Neuroscience b
 Actin regulation  b b b b
 Reduction of inflammation  b b b b b
  4




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Collagen and laminin-5 stimulation  b
 Apoptosis  b b b
 b b
 Clinical Development
  RGN-137 Clinical Trials
 Pressure ulcers. b 2
 b
 Venous stasis ulcers. 2
  Epidermolysis bullosa .
   5




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Future
Plans with RGN-137. b
 RGN-259 Clinical Trials
 b
    Future Plans with RGN-259.
 RGN-352 Clinical Trials
 b
  6




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Future Plans with RGN-352.
  RGN-457 (inhaled formulation of T b 4)
 b
 Product Development
 Pharmaceutical Strategy.
  Cosmeceutical Strategy in vitro
 Manufacturing
 b
 b
  7




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




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b
 Proprietary Rights
 b
 b b
 b b
 b
  9




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Material Agreements
 National Institutes of Health.
 Defiante Farmaceutica, S.A. b b b b
 b
  Development Agreements
 b b
 Employees
  Corporate Information
  Available Information
 www.regenerx.com
  10




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Item 1A. Risk Factors
 Risks Related to Our Liquidity and Need for Financing
 The report of our independent registered public accounting firm contains explanatory
language that substantial doubt exists about our ability to continue as a going concern.
  We estimate that our current liquidity and capital resources are sufficient to fund our
operations into the third quarter of 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, address our liabilities, and raise
additional capital for our existing business. We are pursuing asset out-licenses, asset sales,
mergers and similar strategic transactions. There can be no assurance that we will be successful
in executing a strategic transaction.
  We have incurred losses since inception and expect to incur significant losses in the
foreseeable future and may never become profitable.
 b
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The recent downturn in the U.S. economy and the recent pressure on capital markets increase
the possibility, 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.
  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 may make capital raising efforts more difficult.
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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.
     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;
  13




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
    
    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.
  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.
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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.
   15




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Mauro Bove, a member of our Board, is also a director and officer of Sigma-Tau 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.
   
    
    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
  16




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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
  
    
    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.
 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.
   17




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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.
   18




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Clinical trials could be delayed or fail to show efficacy, resulting in additional cost or
failure to commercialize our technology platform.
  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.
  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.
  19




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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.
  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.
  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
  20




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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.
   21




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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.
  Our principal stockholders have significant voting power and may take actions that may not
be in the best interests of our other stockholders.
   22




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Our rights to repurchase certain shares of stock held by Sigma-Tau Group 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.
    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.
   23




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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.
  
 Item 1B. Unresolved Staff Comments.
  
 Item 2. Properties.
  
 Item 3. Legal Proceedings.
  
 Item 4. Reserved.
  24




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PART II
 
 Item 5. Market for Registrants Common Equity, Related Stockholder Matters
and Issuer Purchases of Securities.
   2009
    
    
    2008High
    
    
    Low
    
    
    High
    
    
    LowFirst Quarter
    
    $
    1.75
    
    
    $
    0.42
    
    
    $
    1.10
    
    
    $
    0.80Second Quarter
    
    $
    0.85
    
    
    $
    0.45
    
    
    $
    1.92
    
    
    $
    0.83Third Quarter
    
    $
    1.12
    
    
    $
    0.52
    
    
    $
    1.43
    
    
    $
    1.02Fourth Quarter
    
    $
    0.83
    
    
    $
    0.55
    
    
    $
    1.66
    
    
    $
    0.85
   
 Item 6. Selected Financial Data.
  
 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
   25




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b b in vitro in vitro
    b
 b b b
    26




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Critical Accounting Policies
  Share-based payment.
  Costs of pre-clinical studies and clinical trials.
 Recent Accounting Pronouncements
       27




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Results of Operations
 Comparison of years ended December 31, 2009 and 2008
 Revenues
 Expenses  Research and development
       Expenses  General and administrative
 Interest Income
  28




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Liquidity and Capital Resources
    Cash Flows
 Net Cash Used in Operating Activities.
 Net Cash Provided by Investing Activities.
 Net Cash Provided by Financing Activities.
 Future Funding Requirements
   
    
    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,
  29




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
    
    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.
    Sources of Liquidity
  b
    30




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Off Balance Sheet Arrangements
  
 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.
   Managements Annual Report on Internal Control over Financial Reporting
   31




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Internal ControlIntegrated Framework
  Changes in Internal Control over Financial Reporting
  
 Item 9B. Other Information.
   32




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PART III
 
 Item 10. Directors, Executive Officers and Corporate Governance.
 Executive Officers and Directors
   Name
    
    Age
    
    PositionExecutive Officers:Mr. J.J. Finkelstein
    
    58
    
    President, Chief Executive Officer and DirectorMr. C. Neil Lyons
    
    53
    
    Chief Financial OfficerMr. David R. Crockford
    
    64
    
    Vice President, Clinical and Regulatory AffairsDirectors:Dr. Allan L. Goldstein
    
    72
    
    Former Chairman, Department of Biochemistry and Molecular Biology, The George Washington University School of Medicine and Health Sciences; Founder, Chairman of the Board and Chief Scientific AdvisorMr. Richard J. Hindin
    
    67
    
    EntrepreneurMr. Joseph C. McNay
    
    76
    
    Chairman, Chief Investment Officer and Managing Principal, Essex Investment Management CompanyMr. Mauro Bove
    
    55
    
    Head of Corporate and Business Development and Director, Sigma-Tau Finanziaria S.p.A and certain of its affiliatesDr. L. Thompson Bowles, M.D.
    
    78
    
    Retired, former thoracic surgeon and former Dean of Medicine and Professor of Surgery, The George Washington University School of Medicine and Health Sciences
 Mr. Finkelstein
 Mr. Lyons
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Mr. Crockford Development of Thymosin ß4 for
Treatment of Patients with Ischemic Heart Disease
 Dr. Goldstein  a b b
 Mr. Hindin
 Mr. McNay
 Mr. Bove
  34




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Dr. Bowles
 Section 16(a) Beneficial Ownership Reporting Compliance
   Corporate Code of Conduct and Ethics
  Audit Committee and Audit Committee Financial Expert
    
 Item 11. Executive Compensation.
 Summary Compensation Table
    35




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Non-EquityIncentiveOption
    
    
    Plan
    
    
    All OtherSalary(1)
    
    
    Bonus(2)
    
    
    Awards(3)
    
    
    Compensation(4)
    
    
    Compensation(5)
    
    
    TotalName and Principal Position
    
    Year
    
    
    ($)
    
    
    ($)
    
    
    ($)
    
    
    ($)
    
    
    ($)
    
    
    ($)Mr. J.J. Finkelstein, President and
    
    
    2009
    
    
    
    244,608
    
    
    
    18,720
    
    
    
    116,198
    
    
    
    
    
    
    
    13,005
    
    
    
    392,531Chief Executive Officer
    
    
    2008
    
    
    
    299,520
    
    
    
    22,464
    
    
    
    86,137
    
    
    
    14,976
    
    
    
    17,690
    
    
    
    440,787Mr. C. Neil Lyons,
    
    
    2009
    
    
    
    167,093
    
    
    
    11,140
    
    
    
    74,395
    
    
    
    
    
    
    
    4,999
    
    
    
    257,627Chief Financial Officer
    
    
    2008
    
    
    
    200,817
    
    
    
    12,152
    
    
    
    68,848
    
    
    
    10,127
    
    
    
    8,508
    
    
    
    300,452Mr. David R. Crockford, Vice President,
    
    
    2009
    
    
    
    210,223
    
    
    
    5,781
    
    
    
    
    
    
    
    
    
    
    
    6,818
    
    
    
    222,822Clinical and Regulatory Affairs
    
    
    2008
    
    
    
    209,203
    
    
    
    12,613
    
    
    
    51,682
    
    
    
    10,511
    
    
    
    11,681
    
    
    
    295,690
 (1)
    
    Reflects base salary before pretax contributions and therefore includes compensation deferred under our 401(k) plan.(2)
    
    Reflects the discretionary portion of our bonus plan.(3)
    
    These amounts reflect the aggregate full grant date fair values (computed in accordance with FASB ASC Topic 718) of options granted to executives during the respective fiscal years.(4)
    
    Reflects amounts earned under our bonus plan subject to the achievement of corporate performance goals.(5)
    
    Primarily reflects our match of executive compensation deferrals into our 401(k) plan, along with supplemental life and disability insurance premiums. None of the individual items exceeded $10,000. Employment Agreements; Potential Payments Upon Termination or Change in Control
  J.J. Finkelstein
     36




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C. Neil Lyons
    David R. Crockford
    37




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Outstanding Equity Awards at December 31, 2009
  Number ofShares
    
    
    Number of SharesUnderlying
    
    
    UnderlyingUnexercised
    
    
    Unexercised
    
    
    Option ExerciseOptions (#)
    
    
    Options (#)
    
    
    Price
    
    
    OptionName
    
    Exercisable
    
    
    Unexercisable
    
    
    ($)
    
    
    Expiration Date
    
    
    NoteMr. Finkelstein
    
    
    500,000
    
    
    
    
    
    
    
    0.33
    
    
    
    1/1/2012100,000
    
    
    
    
    
    
    
    3.21
    
    
    
    4/1/201562,500
    
    
    
    62,500
    
    
    
    2.34
    
    
    
    3/15/2014
    
    
    
    (1)31,250
    
    
    
    93,750
    
    
    
    1.15
    
    
    
    4/15/2015
    
    
    
    (1)114,748
    
    
    
    
    
    
    
    0.57
    
    
    
    4/10/2019
    
    
    
    125,000
    
    
    
    0.76
    
    
    
    10/11/2016
    
    
    
    (1)Mr. Lyons
    
    
    133,332
    
    
    
    66,668
    
    
    
    3.10
    
    
    
    4/7/2015
    
    
    
    (2)37,500
    
    
    
    37,500
    
    
    
    2.34
    
    
    
    3/15/2014
    
    
    
    (1)18,750
    
    
    
    56,250
    
    
    
    1.50
    
    
    
    6/15/2015
    
    
    
    (1)77,728
    
    
    
    
    
    
    
    0.57
    
    
    
    4/10/2019
    
    
    
    75,000
    
    
    
    0.76
    
    
    
    10/11/2016
    
    
    
    (1)Mr. Crockford
    
    
    15,000
    
    
    
    
    
    
    
    1.07
    
    
    
    7/1/2013125,000
    
    
    
    
    
    
    
    0.86
    
    
    
    1/1/201470,000
    
    
    
    30,000
    
    
    
    3.21
    
    
    
    4/1/2015
    
    
    
    (3)17,500
    
    
    
    7,500
    
    
    
    3.82
    
    
    
    5/25/2015
    
    
    
    (3)25,000
    
    
    
    25,000
    
    
    
    2.15
    
    
    
    1/16/2014
    
    
    
    (1)37,500
    
    
    
    37,500
    
    
    
    2.34
    
    
    
    3/15/2014
    
    
    
    (1)18,750
    
    
    
    56,250
    
    
    
    1.15
    
    
    
    4/15/2015
    
    
    
    (1)
 (1)
    
    This option vests in equal installments on the first four anniversaries of the grant date. In each case these options were granted seven years prior to the listed expiration dates.(2)
    
    This option vests in equal installments on the first six anniversaries of the grant date which was April 7, 2005.(3)
    
    This option vests on the first five anniversaries of the grant date in the following installments: 10%, 15%, 20%, 25%, 30%. In each case these options were granted ten years prior to
the listed expiration dates. Post-Employment Compensation
  Director Compensation
        38




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##### Table of Contents



Director Compensation for Fiscal 2009
 Fees Earned or Paid
    
    
    Option
    
    
    All Otherin Cash
    
    
    Awards
    
    
    Compensation
    
    
    TotalName
    
    ($)
    
    
    ($)(1)
    
    
    ($)
    
    
    ($)Dr. Goldstein
    
    
    
    
    
    
    71,348
    
    
    
    162,466
    (2)
    
    
    233,814Mr. Hindin
    
    
    37,877
    
    
    
    16,039
    
    
    
    
    
    
    
    53,916Dr. Bowles
    
    
    21,105
    
    
    
    11,875
    
    
    
    
    
    
    
    32,980Mr. McNay
    
    
    18,028
    
    
    
    10,917
    
    
    
    
    
    
    
    28,945Mr. Bove
    
    
    16,292
    
    
    
    10,459
    
    
    
    
    
    
    
    26,751
 (1)
    
    These amounts reflect the aggregate full grant date fair values (computed in accordance with FASB ASC Topic 718) of options granted to
directors during 2009, a portion of which vested during 2009 as described above. Options held by each Board member as of December 31,
2009, are as follows: Dr. Goldstein
    
    
    696,942Mr. Hindin
    
    
    237,749Dr. Bowles
    
    
    154,843Mr. McNay
    
    
    228,024Mr. Bove
    
    
    227,155
 (2)
    
    In addition to being Chairman of our Board of Directors, Dr. Goldstein also serves as our Chief Scientific Advisor. In this capacity,
Dr. Goldstein received a base salary of $153,093 for 2009, and a discretionary cash bonus of $9,373. Under Dr. Goldsteins employment
agreement, in the event that his employment is terminated by us without cause, as defined in his employment agreement, or if he
voluntarily terminates his employment within 12 months following a change in control, as defined in his employment agreement, then in
each case, subject to Dr. Goldsteins entering into and not revoking a release of claims in a form acceptable to us, Dr. Goldstein will be
entitled to receive a lump sum severance payment equal to his annual base salary then in effect, plus any earned bonus as of the date of
termination, in each case less applicable taxes and withholdings. Dr. Goldstein is not entitled to receive any continuing health and
welfare benefits as part of our severance obligation to him. If Dr. Goldsteins employment had been terminated for any of the reasons
described in this paragraph as of December 31, 2009, he would have been entitled to receive a lump sum payment of $187,460, less taxes and
withholdings. Dr. Goldstein is eligible to receive options to purchase common stock under the 2000 Plan. The decision to grant any such
options and the terms of such options are within the discretion of our board of directors or the compensation committee. In addition, if
Dr. Goldsteins employment is terminated without cause, or if there is a change in control event, in each case as defined in either
the 2000 Plan or in Dr. Goldsteins employment agreement, then the unvested portion of Dr. Goldsteins options would accelerate in full.
All vested options are exercisable for a period of time following any termination of Dr. Goldsteins employment as may be set forth in the
2000 Plan or in any option agreement between Dr. Goldstein and us.  39




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##### Table of Contents



Item 12. Security Ownership of Certain Beneficial Owners and Management and Related Stockholder Matters.
  Beneficial Ownership(1)Beneficial Owner
    
    Number of Shares
    
    
    Percent of Total5% Stockholders:Entities affiliated with Sigma-Tau Finanziaria, S.p.A.
Via Sudafrica, 20, Rome, Italy 00144
    
    
    30,142,859
    (2)
    
    
    46.9
    %Named Executive Officers and Other Directors:J.J. Finkelstein
    
    
    2,299,636
    (3)
    
    
    3.8
    %Allan L. Goldstein
    
    
    2,152,538
    (4)
    
    
    3.6
    %Richard J. Hindin
    
    
    1,175,459
    (5)
    
    
    1.9
    %Joseph C. McNay
    
    
    1,537,135
    (6)
    
    
    2.5
    %Mauro Bove
    
    
    197,155
    (7)
    
    
    *L. Thompson Bowles
    
    
    124,843
    (8)
    
    
    *C. Neil Lyons
    
    
    329,393
    (9)
    
    
    *David R. Crockford
    
    
    388,750
    (8)
    
    
    *All directors and executive officers as a group (8 persons)
    
    
    38,347,768
    (10)
    
    
    63.5
    %
 
 *
    
    Less than one percent.(1)
    
    This table is based upon information supplied by officers,
directors and principal stockholders. Unless otherwise
indicated in the footnotes to this table and subject to
community property laws where applicable, we believes that
each of the stockholders named in this table has sole
voting and investment power with respect to the shares
indicated as beneficially owned. Applicable percentages are
based on 60,406,828 shares of common stock outstanding on
March 15, 2010, adjusted as required by rules promulgated
by the Securities and Exchange Commission (the SEC).(2)
    
    Consists of 984,615 shares of common stock held of record
held by Sigma-Tau Finanziaria, S.p.A. (Sigma-Tau);
12,011,185 shares of common stock held of record and
589,481 shares of common stock issuable upon exercise of
warrants held by Defiante Farmaceutica S.A. (Defiante), a
subsidiary of Sigma-Tau, that are exercisable within
60 days of March 15, 2010; 5,052,582 shares of common stock
held of record and 1,228,486 shares of common stock
issuable upon exercise of warrants held by
Inverlochy-Consultadoria e Servicos (S.U.) LDA
(Inverlochy), an entity wholly owned by Claudio Cavazza,
who directly and indirectly owns 57% of Sigma-Tau, that are
exercisable within 60 days of March 15, 2010; and 8,175,110
shares of common stock held of record and 2,101,400 shares
of common stock issuable upon exercise of warrants held by
Chaumiere-Consultadoria e Servicos SDC Unipessoal LDA
(Chaumiere), an indirect wholly-owned subsidiary of
Aptafin S.p.A., which is owned by Paolo Cavazza and members
of his family, that are exercisable within 60 days of
March 15, 2010. Paolo Cavazza directly and indirectly owns
38% of Sigma-Tau.(3)
    
    Consists of 1,377,638 shares of common stock held of record by Mr. Finkelstein and 51,000 shares of common stock
held of record by Mr. Finkelsteins minor daughter over which Mr. Finkelstein shares voting and dispositive
power. Also includes 870,998 shares of common stock issuable upon exercise of options exercisable within 60 days
of March 15, 2010.(4)
    
    Consists of 1,586,846 shares of common stock held of record by Dr. Goldstein and 565,692 shares of common stock
issuable upon exercise of options exercisable within 60 days of March 15, 2010.(5)
    
    Consists of 967,710 shares of common stock held of record by Mr. Hindin and 207,749 shares of common stock
issuable upon exercise of options exercisable within 60 days of March 15, 2010.  40




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##### Table of Contents



(6)
    
    Consists of 1,339,111 shares of common stock held of record by Mr. McNay and 198,024 shares of common stock
issuable upon exercise of options exercisable within 60 days of March 15, 2010.(7)
    
    Consists of shares of common stock issuable upon exercise of options exercisable within 60 days of March 15,
2010. Mr. Bove is an officer of Sigma-Tau, but he has no beneficial ownership over the reported securities as he
has no voting or dispositive power with respect to the securities held by Sigma-Tau and its affiliates described
in Note 2 above.(8)
    
    Consists of shares of common stock issuable upon exercise of options exercisable within 60 days of March 15, 2010.(9)
    
    Consists of 10,000 shares of common stock held of record by Mr. Lyons and 319,393 shares of common stock issuable
upon exercise of options exercisable within 60 days of March 15, 2010.(10)
    
    Consists of 31,555,797 shares of common stock held of record, 3,919,367 shares of common stock issuable upon
exercise of warrants exercisable within 60 days of March 15, 2010 and 2,872,604 shares of common stock issuable
upon exercise of options exercisable within 60 days of March 15, 2010. Equity Compensation Plan Information
  Number of securitiesremaining available forNumber of securities to
    
    
    
    
    
    
    future issuance underbe issued upon exercise
    
    
    Weighted-average exercise
    
    
    equity compensation plansof outstanding options,
    
    
    price of outstanding options,
    
    
    (excluding securitieswarrants and rights
    
    
    warrants and rights
    
    
    reflected in column (a))Plan Category
    
    (a)
    
    
    (b)
    
    
    (c)Equity compensation
plans approved by
security holders
    
    
    4,914,112
    
    
    $
    1.53
    
    
    
    1,550,888Equity compensation
plans not approved
by security holders
    
    
    
    
    
    
    
    
    
    
    Total
    
    
    4,914,112
    
    
    $
    1.53
    
    
    
    1,550,888
 
 Item 13. Certain Relationships and Related Transactions, and Director Independence.
 Related Party Transactions
    41




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##### Table of Contents



Director Independence
   
 Item 14. Principal Accounting Fees and Services.
  2009
    
    
    2008Audit fees
    
    $
    76,000
    
    
    $
    51,000Tax fees (1)
    
    
    25,000
    
    
    
    11,650Total Fees
    
    $
    101,000
    
    
    $
    62,650
 (1)
    
    Tax fees include the preparation of our corporate federal and state income tax returns.    42




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##### 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)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 S.A.
    
    Exhibit 10.10 to the Companys
Registration Statement on Form SB-2
(File No. 333-113417) (filed
March 9, 2004)**
  43




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##### Table of Contents



Exhibit No.
    
    Description of Exhibit
    
    Reference*10.4
    ^
    
    Second Amended and Restated Employment
Agreement, dated March 11, 2009,
between the Company and Allan L.
Goldstein, as amended
    
    Exhibit 10.4 to the Companys
Annual Report on Form 10-K (filed
on April 15, 2009)10.5
    ^
    
    Second Amended and Restated Employment
Agreement, dated March 12, 2009,
between the Company and J.J.
Finkelstein, as amended
    
    Exhibit 10.5 to the Companys
Annual Report on Form 10-K (filed
on April 15, 2009)10.6
    ^
    
    Second Amended and Restated Employment
Agreement, dated March 31, 2009,
between the Company and C. Neil Lyons,
as amended
    
    Exhibit 10.6 to the Companys
Annual Report on Form 10-K (filed
on April 15, 2009)10.7
    ^
    
    Second Amended and Restated Employment
Agreement, dated March 31, 2009,
between the Company and David Crockford
    
    Exhibit 10.7 to the Companys
Annual Report on Form 10-K (filed
on April 15, 2009)10.8
    
    
    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)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)
  44




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##### Table of Contents



Exhibit No.
    
    Description of Exhibit
    
    Reference*10.19
    
    
    Form of Warrant
    
    Exhibit 10.1 to the Companys Current Report on
Form 8-K (filed April 16, 2009)10.20
    
    
    Securities Purchase Agreement, dated as of April 13, 2009
    
    Exhibit 10.2 to the Companys Current Report on
Form 8-K (filed April 16, 2009)10.21
    
    
    Form of Common Stock Purchase Warrant
    
    Exhibit 4.1 to the Companys Current Report on
Form 8-K (filed September 30, 2009)10.22
    
    
    Securities Purchase Agreement, dated as of September 30, 2009,
by and between the Company and each of the purchasers identified
on the signature pages thereto
    
    Exhibit 10.1 to the Companys Current Report on
Form 8-K (filed September 30, 2009)10.23
    
    
    Form of Warrant
    
    Exhibit 4.1 to the Companys Current Report on
Form 8-K (filed October 5, 2009)10.24
    
    
    Securities Purchase Agreement, dated as of September 30, 2009
    
    Exhibit 10.1 to the Companys Current Report on
Form 8-K (filed October 5, 2009)10.25
    
    
    Lease by and between RegeneRx Biopharmaceuticals, Inc. and The
Realty Associates Fund V, L.P., dated December 10, 2009
    
    Filed herewith23.1
    
    
    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.  45




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##### Table of Contents



SIGNATURES
  RegeneRx Biopharmaceuticals, Inc.
(Registrant)Date: March 31, 2010
    By:
    /s/ J.J. FinkelsteinJ.J. FinkelsteinPresident and Chief Executive OfficerBy:
    /s/ C. Neil LyonsC. Neil LyonsChief Financial Officer  46




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##### Table of Contents



POWER OF ATTORNEY
   Name
    
    Title
    
    Date/s/ Allan L. Goldstein
    
    Chairman of the Board,
    
    March 31, 2010Allan L. Goldstein
    
    Chief Scientific Advisor, and Director/s/ J.J. Finkelstein
    
    President, Chief Executive Officer,
and Director
    
    March 31, 2010J.J. Finkelstein
    
    (Principal Executive Officer)/s/ C. Neil Lyons
    
    Chief Financial Officer and Treasurer
    
    March 31, 2010C. Neil Lyons
    
    (Principal Financial Officer and
Principal Accounting Officer)/s/ Richard J. Hindin
    
    Director
    
    March 31, 2010Richard J. Hindin/s/ Joseph C. McNay
    
    Director
    
    March 31, 2010Joseph C. McNay/s/ Mauro Bove
    
    Director
    
    March 31, 2010Mauro Bove/s/ L. Thompson Bowles
    
    Director
    
    March 31, 2010L. Thompson Bowles
  47




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##### 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




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##### Table of Contents



REPORT OF INDEPENDENT REGISTERED PUBLIC ACCOUNTING FIRM
 
      
  F - 2




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##### Table of Contents



RegeneRx Biopharmaceuticals, Inc.
 
 Balance Sheets
 December 31,
    
    
    December 31,2009
    
    
    2008ASSETSCurrent assetsCash and cash equivalents
    
    $
    4,355,768
    
    
    $
    5,655,367Prepaid expenses and other current assets
    
    
    196,546
    
    
    
    236,477Total current assets
    
    
    4,552,314
    
    
    
    5,891,844Property and equipment, net of accumulated
depreciation of $98,171 and $81,623
    
    
    8,492
    
    
    
    25,039Other assets
    
    
    22,948
    
    
    
    5,693Total assets
    
    $
    4,583,754
    
    
    $
    5,922,576LIABILITIES AND STOCKHOLDERS EQUITYCurrent liabilitiesAccounts payable
    
    $
    140,206
    
    
    $
    70,554Accrued expenses
    
    
    740,198
    
    
    
    1,255,358Total current liabilities
    
    
    880,404
    
    
    
    1,325,912Commitments
    
    
    
    
    
    
    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; 60,406,828
and 53,622,491 issued and outstanding
    
    
    60,407
    
    
    
    53,623Additional paid-in capital
    
    
    88,144,347
    
    
    
    82,550,585Accumulated deficit
    
    
    (84,501,404
    )
    
    
    (78,007,544
    )Total stockholders equity
    
    
    3,703,350
    
    
    
    4,596,664Total liabilities and stockholders equity
    
    $
    4,583,754
    
    
    $
    5,922,576
   F - 3




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##### Table of Contents



RegeneRx Biopharmaceuticals, Inc.
 
 Statements of Operations
 Years ended December 31,2009
    
    
    2008Sponsored research revenue
    
    $
    
    
    
    $
    168,412Operating expensesResearch and development
    
    
    3,724,514
    
    
    
    7,149,808General and administrative
    
    
    2,781,790
    
    
    
    3,805,346Total operating expenses
    
    
    6,506,304
    
    
    
    10,955,154Loss from operations
    
    
    (6,506,304
    )
    
    
    (10,786,742
    )Interest income
    
    
    12,444
    
    
    
    149,777Net loss
    
    $
    (6,493,860
    )
    
    $
    (10,636,965
    )Basic and diluted net loss per common share
    
    $
    (0.12
    )
    
    $
    (0.21
    )Weighted average number of common shares outstanding
    
    
    55,680,525
    
    
    
    50,967,617
   F - 4




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##### Table of Contents



RegeneRx Biopharmaceuticals, Inc.
 
 Statements of Changes in Stockholders Equity
 Years ended December 31, 2009 and 2008
 Accumulatedother
    
    
    TotalCommon stock
    
    
    Additional
    
    
    Accumulated
    
    
    comprehensive
    
    
    stockholdersShares
    
    
    Amount
    
    
    paid-in capital
    
    
    deficit
    
    
    income/(loss)
    
    
    equityBalance, 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  ASC Topic 730
    
    
    
    
    
    
    
    
    
    
    
    
    
    
    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
    )
    
    $
    
    
    
    $
    4,596,664Issuance of common stock, net of offering costs of $447,933
    
    
    6,784,337
    
    
    
    6,784
    
    
    
    4,845,282
    
    
    
    
    
    
    
    
    
    
    
    4,852,066Share-based compensation expense
    
    
    
    
    
    
    
    
    
    
    748,480
    
    
    
    
    
    
    
    
    
    
    
    748,480Net loss
    
    
    
    
    
    
    
    
    
    
    
    
    
    
    (6,493,860
    )
    
    
    
    
    
    
    (6,493,860
    )Balance, December 31, 2009
    
    
    60,406,828
    
    
    $
    60,407
    
    
    $
    88,144,347
    
    
    $
    (84,501,404
    )
    
    $
    
    
    
    $
    3,703,350
   F - 5




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##### Table of Contents



RegeneRx Biopharmaceuticals, Inc.
 
 Statements of Cash Flows
 Years ended December 31,2009
    
    
    2008Operating activities:Net loss
    
    $
    (6,493,860
    )
    
    $
    (10,636,965
    )Adjustments to reconcile net loss to net cash used in operating
activities:Depreciation and amortization
    
    
    16,547
    
    
    
    19,396Non-cash share-based compensation
    
    
    748,480
    
    
    
    1,096,602Gain on settlement of accrued expenses
    
    
    (100,000
    )
    
    
    Changes in operating assets and liabilities:Accounts receivable
    
    
    
    
    
    
    26,951Prepaid expenses and other current assets
    
    
    39,931
    
    
    
    66,767Other assets
    
    
    (17,255
    )
    
    
    Accounts payable
    
    
    69,652
    
    
    
    (203,007
    )Accrued expenses
    
    
    (415,160
    )
    
    
    (940,150
    )Net cash used in operating activities
    
    
    (6,151,665
    )
    
    
    (10,570,406
    )Investing activities:Sales/maturities of short-term investments
    
    
    
    
    
    
    4,581,135Net cash provided by investing activities
    
    
    
    
    
    
    4,581,135Financing activities:Net proceeds from issuance of common stock
    
    
    4,852,066
    
    
    
    7,947,760Net cash provided by financing activities
    
    
    4,852,066
    
    
    
    7,947,760Net (decrease) increase in cash and cash equivalents
    
    
    (1,299,599
    )
    
    
    1,958,489Cash and cash equivalents at beginning of year
    
    
    5,655,367
    
    
    
    3,696,878Cash and cash equivalents at end of year
    
    $
    4,355,768
    
    
    $
    5,655,367
   F - 6




---



##### Table of Contents



1.
    
    ORGANIZATION AND BUSINESS
 Organization and Nature of Operations. b
 Management Plans to Address Operating Conditions.
 b
   b
  2.
    
    SUMMARY OF SIGNIFICANT ACCOUNTING POLICIES
 Use of Estimates.
 Cash and Cash Equivalents.
 Concentration of Credit Risk.
  F - 7




---



##### Table of Contents



Property and Equipment.
 Impairment of Long-lived Assets.
 Sponsored Research Revenues.
 Research and Development b b b
  Cost of Preclinical Studies and Clinical Trials.
 Patent Costs.
 Income Taxes.
  Net Loss Per Common Share.
  F - 8




---



##### Table of Contents



Share-Based Compensation.
 Fair Value of Financial Instruments.
 Recent Accounting Pronouncements.
     Reclassifications.
 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 - 9




---



##### Table of Contents



4.
    
    LICENSES, INTELLECTUAL PROPERTY, AND RELATED PARTY TRANSACTIONS
 b b
 b b
  5.
    
    COMPOSITION OF CERTAIN FINANCIAL STATEMENT CAPTIONS
  December 31,2009
    
    
    2008Accrued clinical research
    
    $
    496,997
    
    
    $
    944,283Accrued professional fees
    
    
    122,590
    
    
    
    155,000Accrued vacation
    
    
    35,300
    
    
    
    61,714Accrued license fees
    
    
    30,000
    
    
    
    Accrued compensation
    
    
    28,995
    
    
    
    84,361Other
    
    
    26,316
    
    
    
    10,000$
    740,198
    
    
    $
    1,255,358
 6.
    
    EMPLOYEE BENEFIT PLANS
  7.
    
    STOCKHOLDERS EQUITY
 Shareholders Rights Plan.
 Registration Rights Agreements.
  F - 10




---



##### Table of Contents



Common Stock.
       Share-Based Compensation.
 2000 Stock Option and Incentive Plan, as amended.
  F - 11




---



##### Table of Contents



December 31,2009
    
    
    2008Research and development
    
    $
    369,814
    
    
    $
    440,850General and administrative
    
    
    378,666
    
    
    
    655,752$
    748,480
    
    
    $
    1,096,602
  Options outstandingWeightedShares
    
    
    
    
    
    
    
    
    
    
    averageavailable for
    
    
    Number of
    
    
    Exercise price
    
    
    exercisegrant
    
    
    shares
    
    
    range
    
    
    priceDecember 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
    
    
    
    1.72Grants
    
    
    (1,192,939
    )
    
    
    1,192,939
    
    
    
    0.57  0.76
    
    
    
    0.64Exercises
    
    
    
    
    
    
    
    
    
    
    
    
    
    
    Cancellations
    
    
    396,327
    
    
    
    (396,327
    )
    
    
    0.57  2.59
    
    
    
    0.82December 31, 2009
    
    
    1,550,888
    
    
    
    4,914,112
    
    
    $
    0.28  $3.82
    
    
    $
    1.53
  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
    
    
    exercisable
    
    
    life (in years)
    
    
    price$0.28  $0.86
    
    
    2,151,612
    
    
    
    4.5
    
    
    $
    0.50
    
    
    
    1,724,112
    
    
    
    4.0
    
    
    $
    0.43$1.07  $1.93
    
    
    827,500
    
    
    
    5.0
    
    
    $
    1.31
    
    
    
    435,625
    
    
    
    4.6
    
    
    $
    1.40$2.02  $2.68
    
    
    860,000
    
    
    
    4.3
    
    
    $
    2.26
    
    
    
    323,750
    
    
    
    4.4
    
    
    $
    2.31$3.00  $3.82
    
    
    1,075,000
    
    
    
    5.4
    
    
    $
    3.19
    
    
    
    950,832
    
    
    
    5.4
    
    
    $
    3.194,914,112
    
    
    
    
    
    
    
    
    
    
    
    3,434,319Intrinsic value of
in-the-money options,
using the December 31,
2009 closing price of
$0.55
    
    $
    254,450
    
    
    
    
    
    
    
    
    
    
    $
    254,450
 Determining the Fair Value of Options.
 2009
    
    2008Dividend yield
    
    0.0%
    
    0.0%Risk free rate of return
    
    1.9  2.3%
    
    0.8  3.7%Expected life in years
    
    4.75  5.38
    
    1.00  4.75Volatility
    
    71  72%
    
    68  82%Forfeitures
    
    2.61%
    
    
  F - 12




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##### Table of Contents



Warrants to Purchase Common Stock.
  Warrants outstandingWeightedaverageNumber of
    
    
    Exercise price
    
    
    exerciseshares
    
    
    range
    
    
    priceDecember 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
    
    
    
    2.80Grants
    
    
    3,129,011
    
    
    
    0.91  1.12
    
    
    
    1.10Exercises
    
    
    
    
    
    
    
    
    
    
    Cancellations
    
    
    (444,250
    )
    
    
    4.06
    
    
    
    4.06December 31, 2009
    
    
    7,933,851
    
    
    $
    0.91  $4.06
    
    
    $
    2.01
  F - 13




---



##### Table of Contents



8.
    
    INCOME TAXES
  December 31,2009
    
    
    2008Deferred tax assets:Net operating loss carryforwards
    
    $
    16,988,000
    
    
    $
    18,370,000Research and development tax credit carryforward
    
    
    1,710,000
    
    
    
    1,628,000Charitable contribution carryforward
    
    
    37,000
    
    
    
    39,000Accrued vacation
    
    
    8,000
    
    
    
    12,000Accrued expenses
    
    
    163,000
    
    
    
    150,000Amortization
    
    
    5,000
    
    
    
    6,000Depreciation
    
    
    1,000
    
    
    
    Stock option expense
    
    
    975,000
    
    
    
    919,00019,887,000
    
    
    
    21,124,000Less  valuation allowance
    
    
    (19,887,000
    )
    
    
    (21,123,000
    )Net deferred tax asset
    
    
    
    
    
    
    1,000Deferred tax liabilities:Depreciation
    
    
    
    
    
    
    (1,000
    )Net deferred tax amounts
    
    $
    
    
    
    $
    
     F - 14




---



##### Table of Contents



December 31,2009
    
    
    2008Tax benefit at statutory rate
    
    $
    (2,213,000
    )
    
    $
    (3,617,000
    )State taxes
    
    
    (354,000
    )
    
    
    (579,000
    )Permanent M-1s
    
    
    339,000
    
    
    
    563,000Limited/expired net operating loss carryforwards
    
    
    3,546,000
    
    
    
    6,150,000Limited/expired research and development tax credit carryforward
    
    
    120,000
    
    
    
    284,000Research and development tax credit carryforward
    
    
    (202,000
    )
    
    
    (504,000
    )Change in effective tax rate
    
    
    
    
    
    
    (455,000
    )Change in valuation allowance
    
    
    (1,236,000
    )
    
    
    (1,842,000$
    
    
    
    $
    
  9.
    
    COMMITMENTS
 Lease
 Employment Continuity Agreements.
  F - 15




---



##### 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)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 S.A.
    
    Exhibit 10.10 to
the Companys
Registration
Statement on Form
SB-2 (File No.
333-113417) (filed
March 9, 2004)**
  48




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##### Table of Contents



Exhibit No.
    
    Description of Exhibit
    
    Reference*10.4
    ^
    
    Second Amended and Restated Employment
Agreement, dated March 11, 2009,
between the Company and Allan L.
Goldstein, as amended
    
    Exhibit 10.4 to the
Companys Annual
Report on Form 10-K
(filed on April 15,
2009)10.5
    ^
    
    Second Amended and Restated Employment
Agreement, dated March 12, 2009,
between the Company and J.J.
Finkelstein, as amended
    
    Exhibit 10.5 to the
Companys Annual
Report on Form 10-K
(filed on April 15,
2009)10.6
    ^
    
    Second Amended and Restated Employment
Agreement, dated March 31, 2009,
between the Company and C. Neil Lyons,
as amended
    
    Exhibit 10.6 to the
Companys Annual
Report on Form 10-K
(filed on April 15,
2009)10.7
    ^
    
    Second Amended and Restated Employment
Agreement, dated March 31, 2009,
between the Company and David Crockford
    
    Exhibit 10.7 to the
Companys Annual
Report on Form 10-K
(filed on April 15,
2009)10.8
    
    
    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)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)
  49




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##### Table of Contents



Exhibit No.
    
    Description of Exhibit
    
    Reference*10.19
    
    
    Form of Warrant
    
    Exhibit 10.1 to the
Companys Current Report
on Form 8-K (filed April
16, 2009)10.20
    
    
    Securities Purchase Agreement, dated
as of April 13, 2009
    
    Exhibit 10.2 to the
Companys Current Report
on Form 8-K (filed April
16, 2009)10.21
    
    
    Form of Common Stock Purchase Warrant
    
    Exhibit 4.1 to the
Companys Current Report
on Form 8-K (filed
September 30, 2009)10.22
    
    
    Securities Purchase Agreement, dated
as of September 30, 2009, by and
between the Company and each of the
purchasers identified on the
signature pages thereto
    
    Exhibit 10.1 to the
Companys Current Report
on Form 8-K (filed
September 30, 2009)10.23
    
    
    Form of Warrant
    
    Exhibit 4.1 to the
Companys Current Report
on Form 8-K (filed
October 5, 2009)10.24
    
    
    Securities Purchase Agreement, dated
as of September 30, 2009
    
    Exhibit 10.1 to the
Companys Current Report
on Form 8-K (filed
October 5, 2009)10.25
    
    
    Lease by and between RegeneRx
Biopharmaceuticals, Inc. and The
Realty Associates Fund V, L.P.,
dated December 10, 2009
    
    Filed herewith23.1
    
    
    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.  50