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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 March 31, 2010
 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




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##### 



RegeneRx Biopharmaceuticals, Inc.
Form 10-Q
Quarterly Period Ended March 31, 2010
 Index
 Page No.Part I. Financial InformationItem 1. Financial StatementsBalance Sheets at March 31, 2010(unaudited) and December 31, 2009
    
    
    3Statements of Operations for the three months
ended March 31, 2010 and 2009 (unaudited)
    
    
    4Statements of Cash Flows for the three months
ended March 31, 2010 and 2009 (unaudited)
    
    
    5Notes to Financial Statements (unaudited)
    
    
    6-8Item 2. Managements Discussion and Analysis
of Financial Condition and Results of Operations
    
    
    9Item 3. Quantitative and Qualitative
Disclosures About Market Risk
    
    
    16Item 4. Controls and Procedures
    
    
    16Part II. Other InformationItem 1. Legal Proceedings
    
    
    17Item 1A. Risk Factors
    
    
    17Item 2. Unregistered Sales of Equity Securities and
Use of Proceeds
    
    
    34Item 3. Defaults Upon Senior Securities
    
    
    34Item 4. Reserved
    
    
    34Item 5. Other Information
    
    
    34Item 6. Exhibits
    
    
    34-36Signatures
    
    
    37Exhibit 31.1Exhibit 31.2Exhibit 32.1Exhibit 32.2
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Part I  Financial Information
 
 Item 1.
    
    Financial Statements
 RegeneRx Biopharmaceuticals, Inc.
 
 Balance Sheets
 March 31,
    
    
    December 31,2010
    
    
    2009(Unaudited)ASSETSCurrent assetsCash and cash equivalents
    
    $
    3,189,990
    
    
    $
    4,355,768Prepaid expenses and other current assets
    
    
    225,166
    
    
    
    196,546Total current assets
    
    
    3,415,156
    
    
    
    4,552,314Fixed assets, net of accumulated depreciation of $101,444 and $98,171
    
    
    23,443
    
    
    
    8,492Other assets
    
    
    17,255
    
    
    
    22,948Total assets
    
    $
    3,455,854
    
    
    $
    4,583,754LIABILITIES AND STOCKHOLDERS EQUITYCurrent liabilitiesAccounts payable
    
    $
    177,718
    
    
    $
    140,206Accrued expenses
    
    
    588,651
    
    
    
    740,198Total current liabilities
    
    
    766,369
    
    
    
    880,404Commitments
    
    
    
    
    
    
    Stockholders equityPreferred stock, $.001 par value per share, 1,000,000 authorized; no shares issued
    
    
    
    
    
    
    Common stock, par value $.001 per share, 100,000,000 shares authorized;
60,406,828 issued and outstanding
    
    
    60,407
    
    
    
    60,407Additional paid-in capital
    
    
    88,276,191
    
    
    
    88,144,347Accumulated deficit
    
    
    (85,647,113
    )
    
    
    (84,501,404
    )Total stockholders equity
    
    
    2,689,485
    
    
    
    3,703,350Total liabilities and stockholders equity
    
    $
    3,455,854
    
    
    $
    4,583,754
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RegeneRx Biopharmaceuticals, Inc.
 
 Statements of Operations
  Three Months endedMarch 31,2010
    
    
    2009Revenues
    
    $
    
    
    
    $
    Operating expenses:Research and development
    
    
    470,434
    
    
    
    1,661,600General and administrative
    
    
    678,068
    
    
    
    859,568Total operating expenses
    
    
    1,148,502
    
    
    
    2,521,168Loss from operations
    
    
    (1,148,502
    )
    
    
    (2,521,168
    )Interest income
    
    
    2,793
    
    
    
    6,518Net loss
    
    $
    (1,145,709
    )
    
    $
    (2,514,650
    )Basic and diluted net loss per common share
    
    $
    (0.02
    )
    
    $
    (0.05
    )Weighted average number of common shares
outstanding
    
    
    60,406,828
    
    
    
    53,622,491
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RegeneRx Biopharmaceuticals, Inc.
 
 Statements of Cash Flows
  For the Three Months endedMarch 31,2010
    
    
    2009Operating activities:Net loss
    
    $
    (1,145,709
    )
    
    $
    (2,514,650
    )Adjustments to reconcile net loss to net cash
used in operating activities:Depreciation and amortization
    
    
    3,273
    
    
    
    4,467Non-cash share-based compensation
    
    
    131,844
    
    
    
    266,628Gain on settlement of accrued liabilities
    
    
    (141,016
    )
    
    
    Changes in operating assets and liabilities:Prepaid expenses and other current assets
    
    
    (28,620
    )
    
    
    72,405Other assets
    
    
    5,693
    
    
    
    Accounts payable
    
    
    37,512
    
    
    
    301,075Accrued expenses
    
    
    (10,531
    )
    
    
    119,016Net cash used in operating activities
    
    
    (1,147,554
    )
    
    
    (1,751,059
    )Investing activities:Purchase of fixed assets
    
    
    (18,224
    )
    
    
    Net cash used in investing activities
    
    
    (18,224
    )
    
    
    Net decrease in cash and cash equivalents
    
    
    (1,165,778
    )
    
    
    (1,751,059
    )Cash and cash equivalents at beginning of period
    
    
    4,355,768
    
    
    
    5,655,367Cash and cash equivalents at end of period
    
    $
    3,189,990
    
    
    $
    3,904,308
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RegeneRx Biopharmaceuticals, Inc.
 
 Notes to Financial Statements
 For the three months ended March 31, 2010 and 2009 (Unaudited)
 organization, business overview and basis of presentation
 Organization and Nature of Operations.
 Management Plans to Address Operating Conditions.
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Basis of Presentation.
    Use of Estimates.
 Net Loss per Common Share
  Stock Based Compensation
   Income Taxes
   7




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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.
  Subsequent Events
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##### 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
  
    
    RGN-352, an injectable product candidate to treat
cardiovascular diseases, central nervous system diseases,
and other medical indications that may be treated by
systemic administration, for which we intend to initiate
a Phase 2 clinical trial in the second half of 2010;
    
    RGN-259, a topical eye drop for ophthalmic indications
that was evaluated in a small Phase 2 clinical trial and
is currently being supported in compassionate use
studies; and
    
    RGN-137, a topically applied gel for chronic dermal
wounds and reduction of scar tissue that is currently in
a Phase 2 clinical trial for the treatment of the skin
defect epidermolysis bullosa, or EB.
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Neuroscience
   in vitro
   10




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Financial Operations Overview
       11




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Critical Accounting Policies
  Results of Operations
 Comparison of the three months ended March 31, 2010 and 2009
 R&D Expenses
 G&A Expenses.
 Liquidity and Capital Resources
 Overview
   12




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Cash Flows for the Three Months Ended March 31, 2010 and 2009
  Future Funding Requirements
   13




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
    
    the progress of our clinical trials;
    
    the progress of our research activities;
    
    the number and scope of our research programs;
    
    the progress of our preclinical 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 preclinical, 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.
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Sources of Liquidity
       15




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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
  b) Changes in Internal Controls
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Part II  Other Information
 
 Item 1.
    
    Legal Proceedings
 None.
 
 Item 1A.
    
    Risk Factors
  Risks Related to Our Liquidity and Need for Financing
 Without giving effect to the proceeds of our contemplated public offering, we estimate that
our existing capital resources will only be sufficient to fund our operations into the third
quarter of 2010.
   In addition to our current development objectives, we will need substantial additional capital
for the continued development of product candidates through marketing approval and for our
longer-term future operations.
  
    
    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;
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
    
    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.
     We have incurred losses since inception and expect to incur significant losses in the
foreseeable future and may never become profitable.
  
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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.
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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.
  Risks Related to Our Business and Operations
 All of our drug candidates are based on a single compound that has yet to be proven effective
in human subjects.
  We may never be able to commercialize our product candidates.
 in vitro
 
    
    be found ineffective or cause harmful side effects during preclinical
studies or clinical trials;
    
    fail to receive necessary regulatory approvals;
  20




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
    
    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.
  We are subject to intense government regulation, and we may not receive regulatory approvals
for our drug candidates.
   
    
    the FDA or other health regulatory authorities, or
institutional review boards, 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, for reasons
such as the size of the patient population, the proximity
of patients to clinical sites, the eligibility criteria
for the trial, the perceptions of investigators and
patients regarding safety, and the availability of other
treatment options;
    
    clinical trial data is adversely affected by trial conduct or patient withdrawal
prior to completion of the trial;
    
    there may be competition with ongoing clinical trials and scheduling conflicts with
participating clinicians;
    
    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;
  21




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
    
    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;
    
    we are unable to obtain a sufficient supply of manufactured clinical trial materials;
    
    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.
    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.
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
    
    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 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.
  TM
  Even if approved for marketing, our technologies and product candidates are unproven and they
may fail to gain market acceptance.
  
    
    the timing and receipt of marketing approvals;
    
    the safety and efficacy of the products;
  24




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
    
    the emergence of equivalent or superior products;
    
    the cost-effectiveness of the products; and
    
    ineffective marketing.
  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.
  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.
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Governmental and third-party payors may subject any product candidates we develop to sales and
pharmaceutical pricing controls that could limit our product revenues and delay profitability.
  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.
   
    
    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;
  26




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




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If any of our key employees discontinue their services with us, our efforts to develop our
business may be delayed.
  Mauro Bove, a member of our Board, is also a director and officer of entities affiliated with
Sigma-Tau, a relationship which could give rise to a conflict of interest involving Mr. Bove.
   Risks Related To Our Intellectual Property
 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.
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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.
      29




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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.
   30




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Risks Related To Our Securities
 Our common stock price is volatile and has had limited trading volume, and any investment in
our securities could decline substantially in value.
  
    
    results of preclinical 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.
  Our principal stockholders have significant voting power and may take actions that may not be
in the best interests of our other stockholders.
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If securities or industry analysts do not publish research or reports or publish unfavorable
research about our business, the price of our common stock and other securities and their trading
volume could decline.
  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.
  The exercise of options and warrants and other issuances of shares of common stock or
securities convertible into common stock will dilute your interest.
     32




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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.
  As a public company, we continue to be subject to the requirements of Section 404 of the
Sarbanes-Oxley Act. If we are unable to comply with Section 404 in a timely manner it may affect
the reliability of our internal control over financial reporting.
     33




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Item 2.
    
    Unregistered Sales of Equity Securities and Use of Proceeds
  
 Item 3.
    
    Defaults Upon Senior Securities
  
 Item 4.
    
    Reserved
 
 Item 5.
    
    Other Information
  
 Item 6.
    
    Exhibits
 Exhibit No.
    
    Description of Exhibit
    
    Reference*3.1
    
    
    Restated Certificate of Incorporation
    
    Exhibit 3.1 to
Registration
Statement on Form
S-1 (File No.
333-166146) (filed
April 16, 2010)3.2
    
    
    Certificate of Amendment to Restated
Certificate of Incorporation
    
    Exhibit 3.2 to
Registration
Statement on Form
S-1 (File No.
333-166146) (filed
April 16, 2010)3.3
    
    
    Certificate of Amendment to Restated
Certificate of Incorporation
    
    Exhibit 3.3 to
Registration
Statement on Form
S-1 (File No.
333-166146) (filed
April 16, 2010)3.4
    
    
    Certificate of Designation of Series
A Participating Cumulative Preferred
Stock
    
    Exhibit 3.4 to
Registration
Statement on Form
S-1 (File No.
333-166146) (filed
April 16, 2010)3.5
    
    
    Amended and Restated Bylaws adopted
July 26, 2006
    
    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
    
    Exhibit 3.6 to the
Companys
Registration
Statement on Form
S-8 (File No.
333-152250) (filed
July 10, 2008)
  34




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Exhibit No.
    
    Description of Exhibit
    
    Reference*4.1
    
    
    Specimen Stock Certificate
    
    Exhibit 4.1 to
Registration
Statement on Form
S-1 (File No.
333-166146) (filed
April 16, 2010)4.2
    
    
    Specimen Rights Certificate
    
    Exhibit 4.2 to
Registration
Statement on Form
S-1 (File No.
333-166146) (filed
April 16, 2010)4.3
    
    
    Rights Agreement, dated April 29,
1994, between the Company and
American Stock Transfer & Trust
Company, as Rights Agent
    
    Exhibit 4.3 to
Registration
Statement on Form
S-1 (File No.
333-166146) (filed
April 16, 2010)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 4.4 to
Registration
Statement on Form
S-1 (File No.
333-166146) (filed
April 16, 2010)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 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***
  35




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*
    
    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 quarterly 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.  36




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Signatures
  RegeneRx Biopharmaceuticals, Inc.(Registrant)Date: May 17, 2010
    
    /s/ J.J. Finkelstein

J.J. FinkelsteinPresident and Chief Executive Officer/s/ C. Neil Lyons

C. Neil LyonsChief Financial Officer
  37