UNITED STATES
                       SECURITIES AND EXCHANGE COMMISSION
                              WASHINGTON, DC 20549

                                   FORM 10-QSB

                   Quarterly Report Under Section 13 or 15(d)
                     of the Securities Exchange Act of 1934

For the quarterly period ended September 30, 2003
                               ------------------

                                                  Commission file number 0-15070
                                                                         -------
                        REGENERX BIOPHARMACEUTICALS, INC.
        -----------------------------------------------------------------
        (Exact name of small business issuer as specified in its charter)


             Delaware                                 52-1253406
             --------                                 ----------
     (State of Incorporation)                 (IRS Employer I.D. Number)


                             3 Bethesda Metro Center
                                    Suite 700
                            Bethesda, Maryland 20814
                            ------------------------
                    (Address of principal executive offices)


         Issuer's telephone number, including area code: (301) 961-1992
                                                         --------------

Check whether the issuer (1) filed all reports required to be filed by Section
13 or 15(d) of the Exchange Act during the past 12 months (or for such shorter
period that the registrant was required to file such reports), and (2) has been
subject to such filing requirements for the past 90 days.

         Yes  X              No
             ---                ---

29,933,968 shares of RegeneRx Biopharmaceuticals, Inc. Common Stock, par value
$.001 per share, were outstanding as of September 30, 2003.

Transitional Small Business Disclosure Format (Check One)  Yes [ ] No [X]


<PAGE>


                        REGENERX BIOPHARMACEUTICALS, INC.
                                   FORM 10-QSB
                    QUARTERLY PERIOD ENDED SEPTEMBER 30, 2003

                                      INDEX

Part I.   Financial Information                                         Page No.
                                                                        --------
             Item 1.   Financial Statements

                          Balance Sheets at September 30, 2003
                          (unaudited) and December 31, 2002                3

                          Statements of Operations for the three
                          months and nine months ended September 30,
                          2003 (unaudited) and September 30, 2002
                          (unaudited)                                      4

                          Statements of Cash Flows for the nine months
                          ended September 30, 2003 (unaudited) and
                          September 30, 2002 (unaudited)                   5

                          Notes to Financial Statements (unaudited)        6-7

              Item 2.     Management's Discussion and Analysis or Plan
                          of Operation                                     7-8

              Item 3.     Controls and Procedures                          8

Part II.  Other Information

              Item 1.     Legal Proceedings                                9

              Item 2.     Changes in Securities                            9

              Item 3.     Defaults upon Senior Securities                  9

              Item 4.     Submission of matters to a vote of
                          security holders                                 9

              Item 5.     Other information                                9

              Item 6.     Exhibits and Reports on Form 8-K                 10-11

Signatures                                                                 12
Certifications                                                             13-14


                                       2

<PAGE>


PART I - FINANCIAL INFORMATION


Item 1.     Financial Statements
--------------------------------


                        REGENERX BIOPHARMACEUTICALS, INC.
                        ---------------------------------
                                 BALANCE SHEETS
                                 --------------

<TABLE>
<CAPTION>
                                                                      September 30,     December 31,
                                                                          2003             2002
                                                                      ------------    ------------
                                                                      (unaudited)
ASSETS
------

<S>                                                                   <C>            <C>
Current assets
       Cash and cash equivalents                                      $  1,393,679   $     474,338
       Other current assets                                                 83,042          18,929
                                                                      ------------    ------------
              Total current assets                                       1,476,721         493,267

Fixed assets, net                                                            4,032           3,836
Proprietary rights, net                                                     23,673          25,013
Due from related party                                                      20,797          24,817
                                                                      ------------    ------------
              Total assets                                            $  1,525,223    $    546,933
                                                                      ============    ============
LIABILITIES AND STOCKHOLDERS' EQUITY
------------------------------------

Current liabilities
       Accounts payable                                               $     87,360    $    138,984
       Accrued expenses                                                     14,125          78,116
       Letter agreements with vendors                                       20,046          20,046
                                                                      ------------    ------------
              Total current liabilities                                    121,531         237,146
                                                                      ------------    ------------

Commitments                                                                     --              --

Stockholders' equity
       Preferred 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; 29,933,968 and 26,965,479
          issued and outstanding, respectively
                                                                            29,934          26,966
       Additional paid-in capital                                       40,042,447      38,102,136
       Accumulated deficit                                             (38,668,689)    (37,519,315)
       Stock subscriptions                                                      --        (300,000)
                                                                      ------------    ------------
              Total stockholders' equity                                 1,403,692         309,787
                                                                      ------------    ------------
              Total liabilities and stockholders' equity              $  1,525,223    $    546,933
                                                                      ============    ============
</TABLE>

   The accompanying notes are an integral part of these financial statements.


                                       3
<PAGE>

                        REGENERX BIOPHARMACEUTICALS, INC.
                        ---------------------------------
                            STATEMENTS OF OPERATIONS
                            ------------------------
                                   (Unaudited)

<TABLE>
<CAPTION>
                                                    Three-months ended             Nine-months ended
                                                       September 30,                  September 30,
                                              ----------------------------    ----------------------------
                                                  2003             2002           2003           2002
                                              ------------    ------------    ------------    ------------
<S>                                           <C>             <C>             <C>             <C>
Revenues                                      $         --    $         --    $         --    $         --

Expenses
     Research and development                      195,355         201,971         561,735         589,687
     General and administrative                    195,212         145,503         550,331         384,898
                                              ------------    ------------    ------------    ------------
Total expenses                                     390,567         347,474       1,112,066         974,585
                                              ------------    ------------    ------------    ------------
Operating loss                                    (390,567)       (347,474)     (1,112,066)       (974,585)

Other income (expense)
     Other income                                       --             100              --          10,199
     Interest income                                 3,069          12,768           5,641          33,074
     Interest expense                                   --              --         (42,949)             --
                                              ------------    ------------    ------------    ------------
Total other income (expense)                         3,069          12,868         (37,308)         43,273
                                              ------------    ------------    ------------    ------------
Net loss                                      $   (387,498)       (334,606)   $ (1,149,374)   $   (931,312)
                                              ============    ============    ============    ============
Basic and diluted net loss per common share   $      (0.01)   $      (0.01)   $      (0.04)   $      (0.04)
                                              ============    ============    ============    ============
Weighted average number
 of common shares outstanding                   29,933,425      26,923,812      27,957,944      25,110,644
                                              ============    ============    ============    ============
</TABLE>

   The accompanying notes are an integral part of these financial statements.


                                       4
<PAGE>

                        REGENERX BIOPHARMACEUTICALS, INC.
                        ---------------------------------
                            STATEMENTS OF CASH FLOWS
                            ------------------------
                                   (Unaudited)

<TABLE>
<CAPTION>
                                                                                 Nine-months ended
                                                                                   September 30,
                                                                             --------------------------
                                                                                 2003            2002
                                                                             -----------    -----------
<S>                                                                          <C>            <C>
Cash flows from operating activities:
       Net loss                                                              $(1,149,374)   $  (931,312)

Adjustments to reconcile net loss to net
  cash used in operating activities:
          Depreciation and amortization                                            2,998          2,342
          Interest expense related to issuance warrants                           40,649             --
          Stock options issued for consulting services                             8,480             --
          Changes in operating assets and liabilities:
               (Increase) decrease:
                 Other current assets                                            (64,113)       (14,707)
                 Due from related party                                            4,020        (34,118)
               Increase (decrease):
                 Accounts payable                                                (51,624)        20,317
                 Accrued expenses                                                (63,991)        (6,661)
                                                                             -----------    -----------
Net cash used in operating activities                                         (1,272,955)      (964,139)
                                                                             -----------    -----------
Cash flows from investing acctivities:
       Purchase of fixed assets                                                   (1,854)        (4,207)
       Purchase of license agreement                                                  --         (5,000)
                                                                             -----------    -----------
Net cash used in investing activities                                             (1,854)        (9,207)
                                                                             -----------    -----------
Cash flows from financing activities:
       Issuance of common stock                                                2,000,000      1,717,000
       Proceeds from exercise of warrants                                         10,000         13,000
       Proceeds from exercise of options                                           4,150             --
       Repayment of subscriptions receivable                                     190,000             --
       Stock offering costs                                                      (10,000)       (65,232)
                                                                             -----------    -----------
Net cash provided by financing activities                                      2,194,150      1,664,768
                                                                             -----------    -----------
Net increase in cash and cash equivalents                                        919,341        691,422

Cash and cash equivalents at beginning of period                                 474,338        100,490
                                                                             -----------    -----------
Cash and cash equivalents at end of period                                   $ 1,393,679    $   791,912
                                                                             ===========    ===========

Disclosure of non-cash transactions:

       Surrender of common stock for repayment of subscriptions receivable   $   110,000             --
       Issuance of common stock for licensing agreement                      $        --         21,200
                                                                             ===========    ===========
</TABLE>

   The accompanying notes are an integral part of these financial statements.


                                       5
<PAGE>

                        REGENERX BIOPHARMACEUTICALS, INC.
                          NOTES TO FINANCIAL STATEMENTS
  FOR THE THREE-MONTH AND NINE-MONTH PERIODS ENDED SEPTEMBER 30, 2003 AND 2002
                                   (UNAUDITED)

A.    GENERAL
      -------

RegeneRx Biopharmaceuticals, Inc. (the "Company"), a Delaware corporation, was
incorporated in 1982. The Company operates predominately in a single industry
segment, the biotechnology industry. In general, the biotechnology industry
consists of researching and developing new pharmaceutical products for the
treatment of diseases or conditions that arise as a result of infections,
cancer, autoimmune disease and genetic abnormalities. The Company's current
primary business focus is the commercialization of Thymosin beta 4, a 43 amino
acid peptide. The Company is concentrating its efforts on the use of Thymosin
beta 4 for the treatment of injured tissue and non-healing wounds to enable more
rapid repair and/or tissue regeneration.

The Company currently has no products that have received regulatory approval.
During 1997, the Company entered into a Material Transfer Agreement -
Cooperative Research and Development Agreement ("CRADA") with the National
Institutes of Health ("NIH"). In exchange for providing Thymosin beta 4 and
certain data, the Company received an option to elect to negotiate for an
exclusive or non-exclusive commercialization license from the NIH pursuant to a
patent application filed by NIH in 1998. On February 6, 2001, the Company signed
a licensing agreement with NIH whereby the Company obtained an exclusive
world-wide license to Thymosin beta 4 under the patent application filed in
1998. In exchange for the exclusive license, the Company must make certain
royalty and milestone payments to the NIH. To date, all payments due have been
made.

B.     FINANCIAL STATEMENTS
       --------------------

The Balance Sheet as of September 30, 2003, the Statements of Operations for the
three-month and nine-month periods ended September 30, 2003 and September 30,
2002, and the Statements of Cash Flows for the nine-month periods ended
September 30, 2003 and September 30, 2002, have been prepared without audit. In
the opinion of management, all adjustments necessary to present fairly the
financial position, results of operations, and cash flows at September 30, 2003,
and for the periods then ended, have been recorded. All adjustments recorded
were of a normal recurring nature.

The accompanying unaudited financial statements have been prepared in accordance
with generally accepted accounting principles for interim financial information
and pursuant to rules and regulations of the Securities and Exchange Commission.
Accordingly, they do not include all of the information and footnotes required
by accounting principles generally accepted in the United States for complete
financial statement presentation. In the opinion of management, such unaudited
interim information reflects all necessary adjustments, consisting of only
normal recurring adjustments, necessary to present the Company's financial
position and results of operations for the periods presented. The results of
operations for interim periods are not necessarily indicative of the results to
be expected for a full fiscal year. These statements should be read in
conjunction with the financial statements and related notes included in the
Company's Form 10-KSB for the year ended December 31, 2002.

The preparation of financial statements in conformity with accounting principles
generally accepted in the United States requires management to make estimates
and assumptions that affect the reported amounts of assets and liabilities and
disclosure of contingent assets and liabilities at the date of the financial
statements, and reported amounts of revenue and expenses during the reported
period. Actual results could differ from those estimates.


                                       6

<PAGE>

C.    NET INCOME (LOSS) PER SHARE
      ---------------------------

Net income (loss) per share is based on the weighted average number of common
shares outstanding during the three month and nine month periods ended September
30, 2003 and September 30, 2002. During these periods options were not included
in the calculation as their effect would be antidilutive.

ITEM 2.  MANAGEMENT'S DISCUSSION AND ANALYSIS OR PLAN OF OPERATION
------------------------------------------------------------------

This item should be read in conjunction with the unaudited financial statements
and notes thereto of the Company contained in Item 1 of this report.

PLAN OF OPERATION

Since its inception in 1982, the Company's activities had consisted of
conducting research and development, sponsoring clinical trials of its
proprietary products, the construction and equipping of laboratory and
production facilities, and the manufacture of products for research, testing and
clinical trials. In 2000, the Company adopted a modified business plan calling
on the outsourcing of most of the activities necessary to its mission of
developing its Thymosin beta 4 technology for the treatment of chronic wounds.
This business model allows for the rapid and effective deployment of necessary
resources without the burden of expensive and unwieldy infrastructure. It also
allows the company to expand or contract its efforts depending on capital
resources or other circumstances. The Company has not generated revenues from
operations and does not anticipate generating product revenues or other revenues
from operations for the foreseeable future. During 2001 and 2002, Company earned
no revenues. During the first nine months of 2003, the Company had no revenues
and had operating losses of $1,112,066. The Company's accumulated deficit of
$38,668,689 through September 30, 2003 has been funded primarily by the proceeds
from the issuance of equity securities (and interest earned on such funds), the
licensing of technology developed or acquired by the Company, limited product
sales and royalties, and the sale of royalty rights. The Company will require
substantial funding in order to complete research and development activities,
manufacturing for clinical trials, and the eventual marketing of any products
that the Company intends to develop.

On June 11, 2003, the Company completed the sale of 3,184,713 shares of
restricted common stock pursuant to a private placement at a price of $.628 per
share to Defiante Farmaceutica, L.d.a. ("Defiante"), a Portuguese company that
is a wholly owned subsidiary of Sigma-Tau, S.p.A., a pharmaceutical company
headquartered in Rome, Italy. The Company received approximately $2 million in
proceeds. In addition, the Company granted Defiante warrants to purchase up to
$1.5 million of additional restricted common stock of the Company at prices
ranging from $1.00 to $1.25 per share (or higher under certain circumstances)
over a period of 18 months.

Although the Company has no products that have received regulatory approval to
date, the Company's Investigational New Drug Application was accepted by the
United Stated Food and Drug Administration in December 2002 allowing the Company
to commence the human testing of Thymosin beta 4 for dermal wounds. The Company
initiated a Phase I human clinical trial in March 2003, which studies were
designed to establish safety in human subjects, and successfully completed the
trial in September 2003. There were no drug-related adverse events reported in
the study. The Company is seeking to raise additional capital for several Phase
II trials which are expected to begin in the first half of 2004. The Company
believes each of the Phase II trials, which it hopes to conduct on similar
parallel tracks, will take approximately 12-15 months each and will cost, in the
aggregate, approximately $2 million. The Company plans to independently develop
Thymosin beta 4 in the United States for chronic dermal wounds through
completion of Phase III clinical trials. The Company is also seeking, within the
next six months, to enter into a strategic relationship with at least one
partner to develop its technology on a parallel track in markets outside the
United States or for clinical indications the Company is not presently pursuing.

At September 30, 2003, the Company had cash and cash equivalents totaling
$1,393,679 and working capital of $1,355,190 and total assets were $1,525,223.
The Company believes that its cash balances will be sufficient to sustain
current operations at least through June 30, 2004. The Company is currently
pursuing several potential financing alternatives for continuation of its
research, development and clinical trials programs. There is no assurance that
the Company will be able to raise additional capital necessary to timely execute
its current plan of operation or


                                       7
<PAGE>

continue such plan of operation beyond June 2004 unless  substantial  additional
capital is raised.

As the Company utilizes a virtual company strategy it does not currently expect
to purchase or sell any properties or significant equipment and does not expect
to have significant changes in the number of its employees. For more information
about the Company's virtual company strategy, see "Item 1. Business" of the
Annual Report on Form 10-KSB for the fiscal year ended December 31, 2002.

FORWARD-LOOKING STATEMENTS

When used in this Form 10-QSB and in future filings by the Company with the
Securities and Exchange Commission, in the Company's press releases or other
public or shareholder communications, and in oral statements made with the
approval of an authorized executive officer, the words or phrases "will likely
result," "are expected to," "will continue," "is anticipated," "estimate,"
"project," "seeks," "plans," or similar expressions are intended to identify
"forward-looking statements" within the meaning of the Private Securities
Litigation Reform Act of 1995. These statements are subject to certain risks and
uncertainties, that could cause actual results to differ materially from
historical results and those presently anticipated or projected. The Company
wishes to caution readers not to place undue reliance on any forward-looking
statements, which speak only as of the date made. The Company wishes to advise
readers that various factors could affect the Company's financial performance
and could cause the Company's actual results for future periods to differ
materially from any opinions or statements expressed with respect to future
periods in any current statements. These factors include, but are not limited
to, the following: the Company's lack of revenues and history of losses;
uncertainties related to the Company's limited capital resources; risks
associated with the development of the Company's products; uncertainties related
to the regulatory process; the Company's lack of product diversification; the
Company's dependence on collaborative relationships with larger partners for the
development, manufacturing and marketing of its products; reliance upon key
personnel; the Company's ability to obtain and protect intellectual property
rights; and competition. For a discussion of these and other factors, see
Exhibit 99.1 to the Company's Annual Report on Form 10-KSB for the year ended
December 31, 2002. The Company does not undertake, and specifically declines any
obligation, to publicly release the result of any revisions that may be made to
any forward-looking statements to reflect events or circumstances after the date
of such statements or to reflect the occurrence of anticipated or unanticipated
events.

ITEM 3.  CONTROLS AND PROCEDURES
--------------------------------

As of the end of the period covered by this report, based on an evaluation of
the Company's disclosure controls and procedures (as defined in Rules 13a-15(e)
and 15d-15(e) under the Securities Exchange Act of 1934) the chief executive and
financial officer of the Company has concluded that the Company's disclosure
controls and procedures are effective to ensure that information required to be
disclosed by the Company in its Exchange Act reports is recorded, processed,
summarized and reported within the applicable time periods specified by the
SEC's rules and forms.

There were no significant changes in the Company's internal controls or in any
other factors that could significantly affect those controls subsequent to the
date of the most recent evaluation of the Company's internal controls by the
Company, including any corrective actions with regard to any significant
deficiencies or material weaknesses.


                                       8
<PAGE>

                           PART II - OTHER INFORMATION


ITEM 1.           LEGAL PROCEEDINGS
-----------------------------------

                  None


ITEM 2.           CHANGES IN SECURITIES
---------------------------------------

                  None


ITEM 3.           DEFAULTS UPON SENIOR SECURITIES
-------------------------------------------------

                  None


ITEM 4.           SUBMISSION OF MATTERS TO A VOTE OF SECURITY HOLDERS
---------------------------------------------------------------------

                  None


ITEM 5.           OTHER INFORMATION
-----------------------------------

                  None


                                       9

<PAGE>

ITEM 6. EXHIBITS AND REPORTS ON FORM 8-K
----------------------------------------

<TABLE>
<CAPTION>

(a)      Exhibits
         --------

             Exhibit No.       Description of Exhibit                      Reference*
             -----------       ----------------------                      ----------
<S>          <C>               <C>                                         <C>
             3.1               Restated Certificate of Incorporation of    Exhibit 3.1 to Registration Statement No.
                               the Company                                 33-9370, Amendment No. 1 (filed November 26,
                                                                           1986)

             3.2               Amendment to Restated Certificate of        Exhibit 3.2 to the Company's Transitional
                               Incorporation of Company                    Report on Form 10-K, File No. 0-15070 (filed
                                                                           March 18, 1991)

             3.3               Amendment to Restated Certificate of        Exhibit 3.3 to the Company's Form 10-KSB,
                               Incorporation of Company                    File No. 0-15070 (filed April 2, 2001)

             3.4               Bylaws of Company                           Exhibit 3.2 to Registration Statement No.
                                                                           33-9370 (filed October 8, 1986)

             3.5               Amendment No. 1 to Bylaws of Company        Exhibit 4.7 to Registration Statement No.
                               adopted August 11, 1989                     33-34551, Amendment No. 3 (filed June 21,
                                                                           1990)

             3.6               Amendment No. 2 to Bylaws of Company        Exhibit 4.8 to Registration Statement No.
                               adopted June 18, 1990                       33-34551, Amendment No. 3 (filed June 21,
                                                                           1990)

             3.7               Amendment No. 3 to Bylaws of Company        Exhibit 3.6 to the Company's Transitional
                               adopted November 30, 1990                   Report on Form 10-K, File No. 0-15070 (filed
                                                                           March 18, 1991)

             4.1               Form of Stock Certificate                   Exhibit 4.1 to Registration Statement No.
                                                                           33-9370, Amendment No. 1 (filed November 26,
                                                                           1986)

             4.2               Rights Agreement, dated as of April 29,     Exhibit 1 to the Company's Current Report on
                               1994, between the Company and American      Form 8-K, File No. 0-15070 (filed May 2, 1994)
                               Stock Transfer & Trust Company, as Rights
                               Agent

             4.3               Warrant Agreement, dated March 12, 1997     Exhibit 4.3 to the Company's Annual Report on
                                                                           Form 10-K, File No. 0-15070 (filed March 31,
                                                                           1997)

             10.1              Patent License Agreement - Exclusive,       Exhibit 10.1 to the Company's Form 10-KSB,
                               between the U.S. Public Health Service      File No. 0-15070 (filed April 2, 2001)**
                               and the Company

             10.2              Settlement Agreement and Mutual Release,    Exhibit 10.2 to the Company's Form 10-KSB,
                               dated March 17, 2000, between the Company   File No. 0-15070 (filed April 2, 2001)**
                               and Bachem Biosciences, Inc.
</TABLE>


                                       10

<PAGE>

<TABLE>

<S>          <C>               <C>                                         <C>
             10.3              Amended and Restated Directors Stock        Exhibit 10.25 to the Company's Annual Report
                               Option Plan                                 on Form 10-K, File No. 0-15070 (filed March
                                                                           26, 1993)

             10.4              Amended and Restated 2000 Stock Option      Filed as Exhibit A to the Company's
                               and Incentive Plan                          definitive proxy materials, File No. 0-15070
                                                                           (filed May 20, 2002)

             10.5              Unit Purchase Agreement dated March 12,     Exhibit 10.25 to the Company's Annual Report
                               1997                                        on Form 10-K, File No. 0-15070 (filed March
                                                                           31, 1997)

             10.6              Registration Rights Agreement, dated        Exhibit 10.26 to the Company's Annual Report
                               March 12, 1997                              of Form 10-K, File No. 0-15070 (filed March
                                                                           31, 1997)

             10.7              Lease Agreement dated April 5, 2002         Exhibit 10.7 to the Company's Annual Report
                               between the Company and HQ Global           on Form 10-KSB, File No. 0-15070 (filed March
                               Workplaces, Inc.                            31, 2003)

             31.1              Certification dated November 13, 2003       Certification Pursuant to Section 302 of the
                                                                           Sarbanes-Oxley Act of 2002 (filed herewith)

             32.1              Certification dated November 13, 2003       Certification Pursuant to 18 U.S.C. Section
                                                                           1350, As Adopted Pursuant to Section 906 of
                                                                           the Sarbanes-Oxley Act of 2002 (filed
                                                                           herewith)
</TABLE>

             ---------------------
             *  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.
             ** Portions of this document have been omitted pursuant to a
                request for confidential treatment

(b) Reports on Form 8-K

                                      None.


                                       11

<PAGE>

                                   SIGNATURES


In accordance with the requirements of the Exchange Act, the registrant caused
this report to be signed on its behalf by the undersigned, thereunto duly
authorized.


                                       RegeneRx Biopharmaceuticals, Inc.
                                       ---------------------------------
                                                 (Registrant)





Date: November 13, 2003                /s/ J.J. Finkelstein
                                       ----------------------------------------
                                       J.J. Finkelstein
                                       President and Chief Executive Officer
                                       (Principal Executive Officer and
                                          Principal Financial Officer)


                                       12