##### Table of Contents



Securities and Exchange Commission
 Washington, DC 20549
 FORM 10-Q
 þ
    
    Quarterly Report pursuant to Section 13 or 15(d) of the Securities Exchange Act of 1934
 For the quarterly period ended September 30, 2009
 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 of Incorporation)
    
    (IRS Employer I.D. Number)
 (Address of Principal Executive Offices)
 (Registrants Telephone Number, Including Area Code)
 þ o
 o o
  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




---



##### 



RegeneRx Biopharmaceuticals, Inc.
Form 10-Q
Quarterly Period Ended September 30, 2009
 Index
 Page No.Part I. Financial InformationItem 1. Financial StatementsBalance Sheets at September 30, 2009
(unaudited) and December 31, 2008
    
    
    3Statements of Operations for the three and nine
months ended September 30, 2009 and 2008
(unaudited)
    
    
    4Statements of Cash Flows for the nine months
ended September 30, 2009 and 2008 (unaudited)
    
    
    5Notes to Financial Statements (unaudited)
    
    
    6-9Item 2. Managements Discussion and Analysis
of Financial Condition and Results of Operations
    
    
    10Item 3. Quantitative and Qualitative
Disclosures About Market Risk
    
    
    15Item 4. Controls and Procedures
    
    
    15Part II. Other InformationItem 1. Legal Proceedings
    
    
    16Item 1A. Risk Factors
    
    
    16Item 2. Unregistered Sales of Equity Securities and
Use of Proceeds
    
    
    35Item 3. Defaults Upon Senior Securities
    
    
    35Item 4. Submission of Matters to a Vote of Security Holders
    
    
    35Item 5. Other Information
    
    
    36Item 6. Exhibits
    
    
    36-38Signatures
    
    
    39Exhibit 31.1Exhibit 31.2Exhibit 32.1Exhibit 32.2
   2




---



##### Table of Contents



Part I  Financial Information
 
 Item 1.
    
    Financial Statements
 RegeneRx Biopharmaceuticals, Inc.
 
 Balance Sheets
 September 30,
    
    
    December 31,2009
    
    
    2008(Unaudited)ASSETSCurrent assetsCash and cash equivalents
    
    $
    1,108,870
    
    
    $
    5,655,367Prepaid expenses and other current assets
    
    
    266,069
    
    
    
    236,477Total current assets
    
    
    1,374,939
    
    
    
    5,891,844Fixed assets, net of accumulated
depreciation of $94,201 and $81,623
    
    
    12,461
    
    
    
    25,039Other non-current assets
    
    
    5,693
    
    
    
    5,693Total assets
    
    $
    1,393,093
    
    
    $
    5,922,576LIABILITIES AND STOCKHOLDERS EQUITYCurrent liabilitiesAccounts payable
    
    $
    56,750
    
    
    $
    70,554Accrued expenses
    
    
    774,039
    
    
    
    1,255,358Total current liabilities
    
    
    830,789
    
    
    
    1,325,912Commitments
    
    
    
    
    
    
    Stockholders equityPreferred stock, $.001 par value per
share, 1,000,000 authorized; none issued
and outstanding
    
    
    
    
    
    
    Common stock, par value $.001 per share,
100,000,000 shares authorized; 54,675,122
and 53,622,491 issued and outstanding at
September 30, 2009 and December 31, 2008,
respectively
    
    
    54,675
    
    
    
    53,623Additional paid-in capital
    
    
    83,730,656
    
    
    
    82,550,585Accumulated deficit
    
    
    (83,223,027
    )
    
    
    (78,007,544
    )Total stockholders equity
    
    
    562,304
    
    
    
    4,596,664Total liabilities and stockholders equity
    
    $
    1,393,093
    
    
    $
    5,922,576
   3




---



##### Table of Contents



RegeneRx Biopharmaceuticals, Inc.
 
 Statements of Operations
  Three Months ended September 30,
    
    
    Nine Months ended September 30,2009
    
    
    2008
    
    
    2009
    
    
    2008Sponsored research revenue
    
    $
    
    
    
    $
    136,245
    
    
    $
    
    
    
    $
    168,412Operating expenses:Research and development
    
    
    648,418
    
    
    
    1,766,350
    
    
    
    3,064,248
    
    
    
    5,198,515General and administrative
    
    
    593,965
    
    
    
    773,892
    
    
    
    2,161,539
    
    
    
    2,954,177Total operating expenses
    
    
    1,242,383
    
    
    
    2,540,242
    
    
    
    5,225,787
    
    
    
    8,152,692Loss from operations
    
    
    (1,242,383
    )
    
    
    (2,403,997
    )
    
    
    (5,225,787
    )
    
    
    (7,984,280
    )Interest income
    
    
    1,254
    
    
    
    30,606
    
    
    
    10,304
    
    
    
    138,340Net loss
    
    $
    (1,241,129
    )
    
    $
    (2,373,391
    )
    
    $
    (5,215,483
    )
    
    $
    (7,845,940
    )Basic and diluted net loss per common share
    
    $
    (0.02
    )
    
    $
    (0.05
    )
    
    $
    (0.10
    )
    
    $
    (0.16
    )Weighted average number of common shares
outstanding
    
    
    54,675,122
    
    
    
    51,553,527
    
    
    
    54,216,430
    
    
    
    50,604,767
   4




---



##### Table of Contents



RegeneRx Biopharmaceuticals, Inc.
 
 Statements of Cash Flows
  For the Nine Months endedSeptember 30,2009
    
    
    2008Operating activities:Net loss
    
    $
    (5,215,483
    )
    
    $
    (7,845,940
    )Adjustments to reconcile net loss to net cash used in operating activities:Depreciation and amortization
    
    
    12,578
    
    
    
    14,802Non-cash share-based compensation
    
    
    607,440
    
    
    
    820,959Changes in operating assets and liabilities:Accounts receivable
    
    
    
    
    
    
    26,951Prepaid expenses and other current assets
    
    
    (29,592
    )
    
    
    (6,506
    )Accounts payable
    
    
    (13,804
    )
    
    
    128,508Accrued expenses
    
    
    (481,319
    )
    
    
    (977,648
    )Net cash used in operating activities
    
    
    (5,120,180
    )
    
    
    (7,838,874
    )Investing activities:Proceeds from 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
    
    
    573,683
    
    
    
    4,947,760Net cash provided by financing activities
    
    
    573,683
    
    
    
    4,947,760Net (decrease) increase in cash and cash equivalents
    
    
    (4,546,497
    )
    
    
    1,690,021Cash and cash equivalents:Beginning of period
    
    
    5,655,367
    
    
    
    3,696,878End of period
    
    $
    1,108,870
    
    
    $
    5,386,899
   5




---



##### Table of Contents



RegeneRx Biopharmaceuticals, Inc.
 
 Notes to Financial Statements
 For the three and nine months ended September 30, 2009 and 2008 (Unaudited)
 Organization, Business Overview and Basis of Presentation
 Organization and Nature of Operations. b
 Management Plans to Address Operating Conditions.
 b
    6




---



##### Table of Contents



New Accounting Standards
      7




---



##### Table of Contents



Sponsored Research Revenues
  Net Loss per Common Share
  E. Stock-Based Compensation
    2009
    
    
    2008Dividend yield
    
    
    0.0
    %
    
    
    0.0
    %Risk free rate of return
    
    
    1.9
    %
    
    
    2.7  3.7
    %Expected life in years
    
    
    5.38
    
    
    
    4.75Volatility
    
    
    72
    %
    
    
    68  73
    %Forfietures
    
    
    2.6
    %
    
    
    0.0
    %
  8




---



##### Table of Contents



Income Taxes
  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.
  H. Equity
  I. Subsequent Event
  
    
    On October 5, 2009, we issued 4,512,194 shares of common stock and warrants to purchase
2,256,097 shares of our common stock in a registered direct offering to new institutional
investors, for proceeds of approximately $3.3 million, net of approximately $400,000 of
offering costs.
 
    
    On October 15, 2009, we issued 1,219,512 shares of common stock and warrants to purchase
609,756 shares of our common stock to an affiliate of Sigma-Tau Group for gross proceeds of
$1.0 million.
 
  9




---



##### Table of Contents



ITEM 2.
    
    Managements Discussion and Analysis of Financial Condition and Results of
Operations
 This Quarterly Report on Form 10-Q, including this Part I., Item 2., 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 future capital resources and funding requirements, 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 Part II., Item 1A. 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.
 Overview
 b  b b
     10




---



##### Table of Contents



b
   b b b
   11




---



##### Table of Contents



Critical Accounting Policies
  Results of Operations
 Comparison of the three months ended September 30, 2009 and 2008
 R&D Expenses
 G&A Expenses.
 Comparison of the nine months ended September 30, 2009 and 2008
 Revenues
  12




---



##### Table of Contents



R&D Expenses
 G&A Expenses.
 Liquidity and Capital Resources
 Sources of Liquidity
   b
   13




---



##### Table of Contents



Cash Flows
 Net Cash Used in Operating Activities.
 Net Cash Provided By Investing Activities.
 Net Cash Provided by Financing Activities.
 Future Funding Requirements
     14




---



##### 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.
   Off Balance Sheet Arrangements
  
 Item 3.
    
    Quantitative and Qualitative Disclosures About Market Risk.
  
 Item 4.
    
    Controls and Procedures
 a) Evaluation of Disclosure Controls and Procedures
   15




---



##### Table of Contents



b) Changes in Internal Controls
  
 Part II  Other Information
 
 Item 1.
    
    Legal Proceedings
  
 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
through the second 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.
   16




---



##### Table of Contents



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.
  We have incurred losses since inception and expect to incur significant losses in the foreseeable
future and may never become profitable.
 b
   17




---



##### Table of Contents



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.
  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.
     18




---



##### 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;
  19




---



##### Table of Contents




    
    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;
 
    
    testing and evaluating a new chemical entity and its effects in highly-complex biological
systems;
  20




---



##### Table of Contents




    
    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;
  21




---



##### Table of Contents




    
    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.
  We are subject to intense government regulation and we may not receive regulatory approvals for our
new drug candidates.
   22




---



##### Table of Contents




    
    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.
  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.
   23




---



##### Table of Contents



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
  24




---



##### 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;
  25




---



##### Table of Contents




    
    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.
     26




---



##### Table of Contents



We face the risk of product liability claims, which could adversely affect our business and
financial condition.
  b
  27




---



##### Table of Contents



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.
  b
   28




---



##### Table of Contents



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.
   29




---



##### Table of Contents



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.
   30




---



##### 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
     31




---



##### 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.
  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;
  32




---



##### Table of Contents




    
    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.
   33




---



##### Table of Contents



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.
     34




---



##### 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.
  
 Item 2.
    
    Unregistered Sales of Equity Securities and Use of Proceeds
  
 Item 3.
    
    Defaults Upon Senior Securities
  
 Item 4.
    
    Submission of Matters to a Vote of Security Holders
   35




---



##### Table of Contents



Votes For
    
    
    Votes WithheldJ.J. Finkelstein
    
    
    46,360,041
    
    
    
    2,497,510Allan L. Goldstein
    
    
    47,098,259
    
    
    
    1,759,292Richard J. Hindin
    
    
    47,070,075
    
    
    
    1,787,476Joseph C. McNay
    
    
    48,491,324
    
    
    
    366,227Mauro Bove
    
    
    48,485,624
    
    
    
    371,927L. Thompson Bowles
    
    
    47,133,225
    
    
    
    1,724,326
   Votes For
    
    Votes Against
    
    
    Abstain
    
    
    Broker Non-Votes48,597,580
    
    
    141,275
    
    
    
    118,695
    
    
    
    
 
 Item 5.
    
    Other Information
  
 Item 6.
    
    Exhibits
 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)
  36




---



##### Table of Contents



Exhibit No.
    
    Description of Exhibit
    
    Reference*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
    
    
    Placement Agency
Agreement, dated as
of September 30,
2009, by and among
the Company, Roth
Capital Partners,
LLC and Boenning &
Scattergood, Inc.
    
    Exhibit 1.1 to the
Companys Current
Report on Form 8-K
(filed September
30, 2009)10.2
    
    
    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)
  37




---



##### Table of Contents



Exhibit No.
    
    Description of Exhibit
    
    Reference*31.1
    
    
    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 herewith32.2
    
    
    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.  38




---



##### Table of Contents



Signatures
  RegeneRx Biopharmaceuticals, Inc.
(Registrant)Date: November 16, 2009
    /s/ J.J. FinkelsteinJ.J. FinkelsteinPresident and Chief Executive Officer/s/ C. Neil LyonsC. Neil LyonsChief Financial Officer  39