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<P STYLE="margin-top: 0; text-align: center; margin-bottom: 0">&nbsp;<B>UNITED STATES</B></P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin-top: 0pt; margin-bottom: 0pt; text-align: center"><B>SECURITIES AND EXCHANGE
COMMISSION</B></P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin-top: 0pt; margin-bottom: 0pt; text-align: center"><B>Washington, D.C. 20549</B></P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin-top: 0pt; margin-bottom: 0pt; text-align: center">&nbsp;</P>

<P STYLE="font: 18pt Times New Roman, Times, Serif; margin-top: 0pt; margin-bottom: 0pt; text-align: center"><B>FORM 8-K</B></P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin-top: 0pt; margin-bottom: 0pt; text-align: center"><B>&nbsp;</B></P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin-top: 0pt; margin-bottom: 0pt; text-align: center"><B>CURRENT REPORT</B></P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin-top: 0pt; margin-bottom: 0pt; text-align: center"><B>Pursuant to Section&nbsp;13
OR 15(d) of the Securities Exchange Act of 1934</B></P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin-top: 0pt; margin-bottom: 0pt; text-align: center"><B>Date of Report (Date of earliest
event reported): July 15, 2012</B></P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin-top: 0pt; margin-bottom: 0pt; text-align: center"><B>&nbsp;</B></P>

<P STYLE="font: 24pt Times New Roman, Times, Serif; margin-top: 0pt; margin-bottom: 0pt; text-align: center"><B>REGENERX BIOPHARMACEUTICALS,
INC.</B></P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin-top: 0pt; margin-bottom: 0pt; text-align: center">(Exact name of registrant as
specified in its charter)</P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin-top: 0pt; margin-bottom: 0pt; text-align: center">&nbsp;</P>

<TABLE ALIGN="CENTER" CELLSPACING="0" CELLPADDING="0" STYLE="width: 100%; border-collapse: collapse; font: 10pt Times New Roman, Times, Serif">
<TR>
    <TD STYLE="vertical-align: top; font-weight: bold; text-align: center; width: 31%; border-bottom: Black 1pt solid">Delaware</TD>
    <TD STYLE="vertical-align: bottom; width: 2%; padding-bottom: 1pt">&nbsp;</TD>
    <TD STYLE="vertical-align: top; font-weight: bold; text-align: center; width: 31%; border-bottom: Black 1pt solid">001-15070</TD>
    <TD STYLE="vertical-align: bottom; width: 2%; padding-bottom: 1pt">&nbsp;</TD>
    <TD STYLE="vertical-align: top; font-weight: bold; text-align: center; width: 31%; border-bottom: Black 1pt solid">52-1253406</TD></TR>
<TR>
    <TD STYLE="vertical-align: top">
        <P STYLE="font: 10pt Times New Roman, Times, Serif; margin-top: 0pt; margin-bottom: 0pt; text-align: center">(State or other jurisdiction</P>
        <P STYLE="font: 10pt Times New Roman, Times, Serif; margin-top: 0pt; margin-bottom: 0pt; text-align: center">of incorporation)</P></TD>
    <TD STYLE="vertical-align: bottom">&nbsp;</TD>
    <TD STYLE="vertical-align: top; text-align: center">(Commission File Number)</TD>
    <TD STYLE="vertical-align: bottom">&nbsp;</TD>
    <TD STYLE="vertical-align: top; text-align: center">(IRS Employer Identification No.)</TD></TR>
</TABLE>
<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0">&nbsp;&nbsp;</P>

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<TR>
    <TD STYLE="vertical-align: top">
        <P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: center"><B>15245 Shady Grove Road, Suite 470</B></P>
        <P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: center"><B>Rockville, MD</B></P></TD>
    <TD STYLE="vertical-align: bottom">&nbsp;</TD>
    <TD STYLE="vertical-align: top">
        <P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: center"><B>&nbsp;</B></P>
        <P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: center; text-indent: 0.5in"><B>20850</B></P></TD></TR>
<TR STYLE="vertical-align: top">
    <TD STYLE="border-top: black 1pt solid">&nbsp;</TD>
    <TD>&nbsp;</TD>
    <TD STYLE="border-top: black 1pt solid">&nbsp;</TD></TR>
<TR>
    <TD STYLE="vertical-align: top; text-align: center">(Address of principal executive offices)</TD>
    <TD STYLE="vertical-align: bottom">&nbsp;</TD>
    <TD STYLE="vertical-align: top; text-align: center">(Zip Code)</TD></TR>
</TABLE>
<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0 0pt 13.2pt; text-align: center">&nbsp;</P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0 0pt 13.2pt; text-align: center">Registrant&rsquo;s telephone
number, including area code:<B> (301) 208-9191</B></P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0 0pt 13.2pt; text-align: center">&nbsp;</P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0 0pt 13.2pt; text-align: center"><B>Not Applicable</B></P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0 0pt 13.2pt; text-align: center">(Former name or former address,
if changed since last report.)</P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0 0pt 13.2pt; text-align: center">&nbsp;</P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0 0pt 13.2pt">Check the appropriate box below if the Form 8-K filing
is intended to simultaneously satisfy the filing obligation of the registrant under any of the following provisions:</P>

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    <TD STYLE="width: 2%; font-family: Wingdings">o</TD>
    <TD STYLE="width: 1%">&nbsp;</TD>
    <TD STYLE="width: 97%">Written communications pursuant to Rule&nbsp;425 under the Securities Act (17 CFR 230.425)</TD></TR>
<TR>
    <TD>&nbsp;</TD>
    <TD>&nbsp;</TD>
    <TD>&nbsp;</TD></TR>
<TR STYLE="vertical-align: top; background-color: white">
    <TD STYLE="font-family: Wingdings">o</TD>
    <TD>&nbsp;</TD>
    <TD>Soliciting material pursuant to Rule&nbsp;14a-12 under the Exchange Act (17 CFR 240.14a-12)</TD></TR>
<TR>
    <TD>&nbsp;</TD>
    <TD>&nbsp;</TD>
    <TD>&nbsp;</TD></TR>
<TR STYLE="vertical-align: top; background-color: white">
    <TD STYLE="font-family: Wingdings">o</TD>
    <TD>&nbsp;</TD>
    <TD>Pre-commencement communications pursuant to Rule&nbsp;14d-2(b) under the Exchange Act (17 CFR 240.14d-2(b))</TD></TR>
<TR>
    <TD>&nbsp;</TD>
    <TD>&nbsp;</TD>
    <TD>&nbsp;</TD></TR>
<TR STYLE="vertical-align: top; background-color: white">
    <TD STYLE="font-family: Wingdings">o</TD>
    <TD>&nbsp;</TD>
    <TD>Pre-commencement communications pursuant to Rule&nbsp;13e-4(c) under the Exchange Act (17 CFR 240.13e-4(c))</TD></TR>
</TABLE>


<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0"></P>

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<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0">&nbsp;</P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0">&nbsp;</P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0"></P>

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<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0">&nbsp;&nbsp;</P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin-top: 0; margin-bottom: 6pt; margin-left: 0in; text-indent: 0in; text-align: justify"><B>Item&nbsp;1.01
Entry into a Material Definitive Agreement.</B></P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0 0pt 13.2pt">&nbsp;</P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin-top: 0; margin-bottom: 0; margin-left: 0in; text-indent: 0.5in; text-align: justify">On
July 15, 2012, RegeneRx Biopharmaceuticals, Inc. (the &ldquo;Company&rdquo;) entered into an agreement (the &ldquo;License Agreement&rdquo;)
with Lee&rsquo;s Pharmaceutical (HK) Limited (&ldquo;Lee&rsquo;s&rdquo;) for the license of Thymosin Beta 4-based products, including
the Company&rsquo;s RGN-259, RGN-352 and RGN-137 product candidates, in China, Hong Kong, Macau and Taiwan (collectively, the
&ldquo;Territory&rdquo;). The Company is entitled to receive a payment of $200,000 from Lee&rsquo;s upon the execution of the
License Agreement. With these funds, together with the $200,000 the Company previously received upon execution of a term sheet
with Lee&rsquo;s in March 2012, the Company expects to be able to fund limited operations into August 2012, without giving effect
to any other sources of funding.</P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0 0pt 13.5pt; text-align: justify; text-indent: 0.6in">&nbsp;</P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin-top: 0; margin-bottom: 0; margin-left: 0in; text-indent: 0.5in; text-align: justify">Under
the License Agreement, the Company is eligible to receive aggregate potential milestone payments of up to $3.6 million, consisting
of (i) $500,000 upon the first commercial sale of a licensed product in China, (ii) $1.5 million upon the achievement of $50 million
in aggregate commercial sales in the Territory and (iii) $1.6 million upon the achievement of $80 million in aggregate commercial
sales in the Territory. In addition, the Company is eligible to receive royalties ranging from low double digit to high single
digit percentages of any commercial sales of the Company&rsquo;s product candidates that are the subject of the agreement. Lee&rsquo;s
will pay for all developmental costs associated with each product candidate. The Company will provide T&beta;4 to Lee&rsquo;s
at no charge for a Phase 2 ophthalmic clinical trial and will provide T&beta;4 to Lee&rsquo;s for all other developmental and
clinical work at a price equal to the Company&rsquo;s cost. RegeneRx will also have the right to exclusively license any improvements
made by Lee&rsquo;s to RegeneRx&rsquo;s products outside of the licensed territory.</P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0 0pt 13.5pt; text-align: justify; text-indent: 0.6in">&nbsp;</P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin-top: 0; margin-bottom: 0; margin-left: 0in; text-indent: 0.5in; text-align: justify">The
two firms will create a joint development committee to discuss and agree on the development of the licensed products and share
information relating thereto. Both companies will also share all non-clinical and clinical data and other information related
to development of the licensed product candidates.</P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0 0pt 13.5pt; text-align: justify; text-indent: 0.6in">&nbsp;</P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin-top: 0; margin-bottom: 0; margin-left: 0in; text-indent: 0.5in; text-align: justify"><FONT STYLE="color: black">Sigma-Tau
Finanziaria S.p.A, together with its subsidiaries and its affiliates, beneficially own approximately 25.9% of Lee&rsquo;s and
38.6% of the Company. </FONT>Mauro Bove is a member of the board of directors of both companies.</P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0 0pt 13.2pt; text-indent: 45.3pt"><FONT STYLE="color: black">&nbsp;</FONT></P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin-top: 0; margin-bottom: 0; margin-left: 0in; text-indent: 0.5in; text-align: justify">The
foregoing summary of the License Agreement is not complete and is qualified in its entirety by reference to the full text of the
License Agreement, which will be filed as an exhibit to the Company&rsquo;s Quarterly Report on Form 10-Q for the quarter ending
September 30, 2012.</P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0 0pt 13.2pt; text-indent: 45.3pt"></P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0 0pt 13.5pt; text-align: justify"><B>&nbsp;</B></P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin-top: 0; margin-bottom: 6pt; margin-left: 0in; text-indent: 0in; text-align: justify"><B>Item
7.01.&#9;Regulation FD Disclosure.</B></P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0 0pt 13.5pt; text-align: justify"><B>&nbsp;</B></P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin-top: 0; margin-bottom: 0; margin-left: 0in; text-indent: 0.5in; text-align: justify">On
July 16, 2012, the Company issued a press release announcing the execution of the License Agreement. A copy of this press release
is furnished as Exhibit 99.1 to this Current Report.</P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0 0pt 13.5pt; text-align: justify"><B>&nbsp;</B></P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin-top: 0; margin-bottom: 0; margin-left: 0in; text-indent: 0in; text-align: justify"><B>Forward-Looking
Statements</B></P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0 0pt 13.5pt; background-color: white">&nbsp;</P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin-top: 0; margin-bottom: 0; margin-left: 0in; text-indent: 0.5in; text-align: justify">Certain
statements in this report are forward-looking statements that involve a number of risks and uncertainties. Such forward-looking
statements include our forecast of the period of time through which our financial resources will be adequate to support our operations.
For such statements, the Company claims the protection of the Private Securities Litigation Reform Act of 1995. Actual events
or results may differ materially from the Company&rsquo;s expectations. Factors that may cause actual results to differ materially
from any future results expressed or implied by any forward-looking statements include risks related to uncertainties inherent
in the Company&rsquo;s business, including, without limitation, the risk that the milestone payments and royalties described in
the this report may not be triggered, the risk that Lee&rsquo;s may be unable to, or may elect not to complete the development
of the product candidates in one or more of the licensed regions, the risk that the Company&rsquo;s product candidates do not
demonstrate safety and/or efficacy in clinical trials; risks related to the Company&rsquo;s ability to obtain financing to support
its operations on commercially reasonable terms; the progress, timing or success of the Company&rsquo;s clinical trials; difficulties
or delays in development, testing, obtaining regulatory approval for producing and marketing the Company&rsquo;s product candidates;
regulatory developments; the size and growth potential of the markets for the Company&rsquo;s product candidates and its ability
to serve those markets; the scope and validity of patent protection for the Company&rsquo;s product candidates; competition from
other pharmaceutical or biotechnology companies; and other risks described in the Company&rsquo;s filings with the Securities
and Exchange Commission (&ldquo;SEC&rdquo;), including those identified in the &ldquo;Risk Factors&rdquo; section of the annual
report on Form 10-K for the year ended December&nbsp;31, 2011, filed with the SEC on April 4, 2012, and subsequent quarterly reports
filed on Form 10-Q, as well as other filings it makes with the SEC. Any forward-looking statements in this report represent the
Company&rsquo;s views only as of the date of this report and should not be relied upon as representing its views as of any subsequent
date. The Company anticipates that subsequent events and developments may cause its views to change, and the Company specifically
disclaims any obligation to update this information, as a result of future events or otherwise, except as required by applicable
law.</P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin-top: 0pt; margin-right: 0; margin-bottom: 0pt; text-align: justify; text-indent: 24.5pt; background-color: white">&nbsp;</P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin-top: 0pt; margin-right: 0; margin-bottom: 0pt; text-align: justify; text-indent: 24.5pt; background-color: white"></P>

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<P STYLE="font: 10pt Times New Roman, Times, Serif; margin-top: 0pt; margin-right: 0; margin-bottom: 0pt; text-align: justify; text-indent: 24.5pt; background-color: white">&nbsp;</P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin-top: 0pt; margin-right: 0; margin-bottom: 0pt; text-align: justify; text-indent: 24.5pt; background-color: white">&nbsp;</P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin-top: 0; margin-bottom: 0; margin-left: 0in; text-indent: 0in; text-align: justify"><B>Item&nbsp;9.01
Financial Statements and Exhibits.</B></P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0 0pt 13.2pt">&nbsp;</P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin-top: 0; margin-bottom: 0; margin-left: 0in; text-indent: 0in; text-align: justify">(d)&nbsp;Exhibits</P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0 0pt 13.2pt">&nbsp;</P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0 0pt 13.2pt"></P>

<TABLE CELLPADDING="0" CELLSPACING="0" STYLE="border-collapse: collapse; width: 100%; font: 10pt Times New Roman, Times, Serif">
<TR STYLE="vertical-align: bottom">
    <TD COLSPAN="2" STYLE="font-size: 10pt; font-weight: bold; text-align: center">Exhibit</TD><TD STYLE="font-size: 10pt; font-weight: bold">&nbsp;</TD><TD STYLE="font-size: 10pt">&nbsp;</TD>
    <TD STYLE="font-size: 10pt; text-align: left">&nbsp;</TD></TR>
<TR STYLE="vertical-align: bottom">
    <TD COLSPAN="2" STYLE="font-size: 10pt; font-weight: bold; border-bottom: Black 1pt solid; text-align: center">Number</TD><TD STYLE="padding-bottom: 1pt; font-size: 10pt; font-weight: bold">&nbsp;</TD><TD STYLE="font-size: 10pt; padding-bottom: 1pt">&nbsp;</TD>
    <TD STYLE="font-size: 10pt; border-bottom: Black 1pt solid; text-align: left">Description</TD></TR>
<TR STYLE="vertical-align: bottom">
    <TD STYLE="font: 10pt Times New Roman, Times, Serif; text-align: center; width: 1%">&nbsp;</TD><TD STYLE="font: 10pt Times New Roman, Times, Serif; text-align: center; width: 8%">&nbsp;</TD><TD STYLE="font: 10pt Times New Roman, Times, Serif; text-align: left; width: 1%">&nbsp;</TD><TD STYLE="font-size: 10pt; width: 2%">&nbsp;</TD>
    <TD STYLE="font-size: 10pt; text-align: left; width: 88%">&nbsp;</TD></TR>
<TR STYLE="vertical-align: bottom">
    <TD COLSPAN="2" STYLE="font: 10pt Times New Roman, Times, Serif; text-align: center">99.1</TD><TD STYLE="font: 10pt Times New Roman, Times, Serif; text-align: left">&nbsp;</TD><TD STYLE="font-size: 10pt">&nbsp;</TD>
    <TD STYLE="font-size: 10pt; text-align: left">&nbsp;Press Release, dated July 16, 2012.</TD></TR>
</TABLE>




<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0 0pt 13.2pt"></P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0 0pt 13.2pt">&nbsp;</P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0 0pt 13.2pt">&nbsp;</P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0 0pt 13.2pt">&nbsp;</P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0 0pt 13.2pt">&nbsp;</P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0 0pt 13.2pt"></P>

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<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0 0pt 13.2pt"></P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0"><B>&nbsp;</B></P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0"><B>&nbsp;</B></P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0"><B>&nbsp;</B></P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: center"><B>SIGNATURE</B></P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0 0pt 13.2pt; text-indent: 23.1pt">Pursuant to the requirements
of the Securities Exchange Act of 1934, the registrant has duly caused this report to be signed on its behalf by the undersigned
thereunto duly authorized.</P>

<TABLE CELLSPACING="0" CELLPADDING="0" STYLE="width: 100%; font: 10pt Times New Roman, Times, Serif; border-collapse: collapse">
<TR>
    <TD STYLE="width: 64%">&nbsp;</TD>
    <TD STYLE="width: -1mm">&nbsp;</TD>
    <TD STYLE="width: 6%">&nbsp;</TD>
    <TD STYLE="width: 28%">&nbsp;</TD>
    <TD STYLE="width: 3%">&nbsp;</TD></TR>
<TR>
    <TD STYLE="vertical-align: top">&nbsp;</TD>
    <TD COLSPAN="3">
        <P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0"><B>REGENERX BIOPHARMACEUTICALS, INC.</B></P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0"><B></B>&nbsp;</P></TD>
    <TD>&nbsp;</TD></TR>
<TR>
    <TD>&nbsp;</TD>
    <TD STYLE="vertical-align: top">By:&nbsp;</TD>
    <TD COLSPAN="2" STYLE="border-bottom: black 1pt solid">/s/ J.J. Finkelstein &nbsp;</TD>
    <TD>&nbsp;</TD></TR>
<TR>
    <TD>&nbsp;</TD>
    <TD>&nbsp;</TD>
    <TD COLSPAN="2">J.J. Finkelstein&nbsp;</TD>
    <TD>&nbsp;</TD></TR>
<TR>
    <TD>&nbsp;</TD>
    <TD>&nbsp;</TD>
    <TD COLSPAN="2">President and Chief Executive Officer&nbsp;</TD>
    <TD>&nbsp;</TD></TR>
</TABLE>
<P STYLE="font: 10pt Times New Roman, Times, Serif; margin-top: 0; margin-bottom: 0; margin-left: 0in; text-indent: 0in; text-align: justify">Date:
July 19, 2012</P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0 0pt 13.2pt; text-align: center">&nbsp;</P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0">&nbsp;</P>

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    <TD COLSPAN="2" STYLE="font: 10pt Times New Roman, Times, Serif; text-align: center">99.1</TD><TD STYLE="font: 10pt Times New Roman, Times, Serif; text-align: left">&nbsp;</TD><TD STYLE="font-size: 10pt">&nbsp;</TD>
    <TD STYLE="font-size: 10pt; text-align: left">&nbsp;Press Release, dated July 16, 2012.</TD></TR>
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{"company-data": {"conformed-name": "REGENERX BIOPHARMACEUTICALS INC", "cik": "0000707511", "assigned-sic": "2834", "irs-number": "521253406", "state-of-incorporation": "DE", "fiscal-year-end": "1231"}, "filing-values": {"form-type": "8-K", "act": "34", "file-number": "001-15070", "film-number": "12970114"}, "business-address": {"street1": "3 BETHESDA METRO CENTER", "street2": "SUITE 700", "city": "BETHESDA", "state": "MD", "zip": "20814", "phone": "3019611992"}, "mail-address": {"street1": "3 BETHESDA METRO CENTER", "street2": "SUITE 700", "city": "BETHESDA", "state": "MD", "zip": "20814"}, "former-company": {"former-conformed-name": "ALPHA 1 BIOMEDICALS INC", "date-changed": "19950719"}}
UNITED STATES
SECURITIES AND EXCHANGE
COMMISSION
Washington, D.C. 20549
FORM 8-K
CURRENT REPORT
Pursuant to Section 13
OR 15(d) of the Securities Exchange Act of 1934
Date of Report (Date of earliest
event reported): July 15, 2012
REGENERX BIOPHARMACEUTICALS,
INC.
(Exact name of registrant as
specified in its charter)
Delaware
001-15070
52-1253406
(State or other jurisdiction
of incorporation)
(Commission File Number)
(IRS Employer Identification No.)
15245 Shady Grove Road, Suite 470
Rockville, MD
20850
(Address of principal executive offices)
(Zip Code)
Registrant's telephone
number, including area code:
(301) 208-9191
Not Applicable
(Former name or former address,
if changed since last report.)
Check the appropriate box below if the Form 8-K filing
is intended to simultaneously satisfy the filing obligation of the registrant under any of the following provisions:
o
Written communications pursuant to Rule 425 under the Securities Act (17 CFR 230.425)
o
Soliciting material pursuant to Rule 14a-12 under the Exchange Act (17 CFR 240.14a-12)
o
Pre-commencement communications pursuant to Rule 14d-2(b) under the Exchange Act (17 CFR 240.14d-2(b))
o
Pre-commencement communications pursuant to Rule 13e-4(c) under the Exchange Act (17 CFR 240.13e-4(c))
Item 1.01
Entry into a Material Definitive Agreement.
On
July 15, 2012, RegeneRx Biopharmaceuticals, Inc. (the "Company") entered into an agreement (the "License Agreement")
with Lee's Pharmaceutical (HK) Limited ("Lee's") for the license of Thymosin Beta 4-based products, including
the Company's RGN-259, RGN-352 and RGN-137 product candidates, in China, Hong Kong, Macau and Taiwan (collectively, the
"Territory"). The Company is entitled to receive a payment of $200,000 from Lee's upon the execution of the
License Agreement. With these funds, together with the $200,000 the Company previously received upon execution of a term sheet
with Lee's in March 2012, the Company expects to be able to fund limited operations into August 2012, without giving effect
to any other sources of funding.
Under
the License Agreement, the Company is eligible to receive aggregate potential milestone payments of up to $3.6 million, consisting
of (i) $500,000 upon the first commercial sale of a licensed product in China, (ii) $1.5 million upon the achievement of $50 million
in aggregate commercial sales in the Territory and (iii) $1.6 million upon the achievement of $80 million in aggregate commercial
sales in the Territory. In addition, the Company is eligible to receive royalties ranging from low double digit to high single
digit percentages of any commercial sales of the Company's product candidates that are the subject of the agreement. Lee's
will pay for all developmental costs associated with each product candidate. The Company will provide Tβ4 to Lee's
at no charge for a Phase 2 ophthalmic clinical trial and will provide Tβ4 to Lee's for all other developmental and
clinical work at a price equal to the Company's cost. RegeneRx will also have the right to exclusively license any improvements
made by Lee's to RegeneRx's products outside of the licensed territory.
The
two firms will create a joint development committee to discuss and agree on the development of the licensed products and share
information relating thereto. Both companies will also share all non-clinical and clinical data and other information related
to development of the licensed product candidates.
Sigma-Tau
Finanziaria S.p.A, together with its subsidiaries and its affiliates, beneficially own approximately 25.9% of Lee's and
38.6% of the Company.
Mauro Bove is a member of the board of directors of both companies.
The
foregoing summary of the License Agreement is not complete and is qualified in its entirety by reference to the full text of the
License Agreement, which will be filed as an exhibit to the Company's Quarterly Report on Form 10-Q for the quarter ending
September 30, 2012.
Item
7.01.	Regulation FD Disclosure.
On
July 16, 2012, the Company issued a press release announcing the execution of the License Agreement. A copy of this press release
is furnished as Exhibit 99.1 to this Current Report.
Forward-Looking
Statements
Certain
statements in this report are forward-looking statements that involve a number of risks and uncertainties. Such forward-looking
statements include our forecast of the period of time through which our financial resources will be adequate to support our operations.
For such statements, the Company claims the protection of the Private Securities Litigation Reform Act of 1995. Actual events
or results may differ materially from the Company's expectations. Factors that may cause actual results to differ materially
from any future results expressed or implied by any forward-looking statements include risks related to uncertainties inherent
in the Company's business, including, without limitation, the risk that the milestone payments and royalties described in
the this report may not be triggered, the risk that Lee's may be unable to, or may elect not to complete the development
of the product candidates in one or more of the licensed regions, the risk that the Company's product candidates do not
demonstrate safety and/or efficacy in clinical trials; risks related to the Company's ability to obtain financing to support
its operations on commercially reasonable terms; the progress, timing or success of the Company's clinical trials; difficulties
or delays in development, testing, obtaining regulatory approval for producing and marketing the Company's product candidates;
regulatory developments; the size and growth potential of the markets for the Company's product candidates and its ability
to serve those markets; the scope and validity of patent protection for the Company's product candidates; competition from
other pharmaceutical or biotechnology companies; and other risks described in the Company's filings with the Securities
and Exchange Commission ("SEC"), including those identified in the "Risk Factors" section of the annual
report on Form 10-K for the year ended December 31, 2011, filed with the SEC on April 4, 2012, and subsequent quarterly reports
filed on Form 10-Q, as well as other filings it makes with the SEC. Any forward-looking statements in this report represent the
Company's views only as of the date of this report and should not be relied upon as representing its views as of any subsequent
date. The Company anticipates that subsequent events and developments may cause its views to change, and the Company specifically
disclaims any obligation to update this information, as a result of future events or otherwise, except as required by applicable
law.
Item 9.01
Financial Statements and Exhibits.
(d) Exhibits
Exhibit
Number
Description
99.1
Press Release, dated July 16, 2012.
SIGNATURE
Pursuant to the requirements
of the Securities Exchange Act of 1934, the registrant has duly caused this report to be signed on its behalf by the undersigned
thereunto duly authorized.
REGENERX BIOPHARMACEUTICALS, INC.
By:
/s/ J.J. Finkelstein
J.J. Finkelstein
President and Chief Executive Officer
Date:
July 19, 2012
EXHIBIT INDEX
Exhibit
Number
Description
99.1
Press Release, dated July 16, 2012.