- Current report filing (8-K)
March 30 2012 - 5:23PM
Edgar (US Regulatory)
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): March 27, 2012
REGENERX BIOPHARMACEUTICALS, INC.
(Exact name of registrant as specified in its charter)
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Delaware
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001-15070
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52-1253406
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(State or other jurisdiction
of incorporation)
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(Commission
File Number)
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(IRS Employer
Identification No.)
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15245 Shady Grove Road, Suite 470
Rockville, MD
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20850
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(Address of principal executive offices)
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(Zip Code)
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Registrants 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:
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Written communications pursuant to Rule 425 under the Securities Act (17 CFR 230.425)
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Soliciting material pursuant to Rule 14a-12 under the Exchange Act (17 CFR 240.14a-12)
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Pre-commencement communications pursuant to Rule 14d-2(b) under the Exchange Act (17 CFR 240.14d-2(b))
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Pre-commencement communications pursuant to Rule 13e-4(c) under the Exchange Act (17 CFR 240.13e-4(c))
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Item 1.01 Entry into a Material Definitive Agreement.
On March 27, 2012 , RegeneRx Biopharmaceuticals, Inc. (the Company) entered into a term sheet with Lees
Pharmaceutical (HK) Limited (Lees) for the license of Thymosin Beta 4-based products, including the Companys RGN-259, RGN-352 and RGN-137 product candidates, in China, Hong Kong and Macau. Lees paid $200,000 to the
Company upon execution of the term sheet, and Lees is obligated to pay the Company an additional $200,000 upon execution of a definitive license agreement, which the Company expects to occur within 60 days of the execution of the term sheet.
The terms of the transaction include aggregate potential milestone payments to the Company of up to $3.6 million and royalties ranging from low double digit to high single digit percentages of any commercial sales of the Companys product
candidates that are the subject of the agreement. The Company shall have an exclusive supply agreement for Tß4 with Lees, although Lees will have the option to manufacture Tß4 for the licensed territory. Lees will pay
for all developmental costs associated with each product candidate. The Company will provide Tß4 to Lees at no charge for a Phase 2 ophthalmic clinical trial and will provide Tß4 to Lees for all other developmental and
clinical work at a price equal to the Companys cost.
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 28% of
Lees and 39% of the Company. Mauro Bove is a member of the board of directors of both companies.
Item 7.01. Regulation FD
Disclosure.
On March 27, 2012, the Company issued a press release announcing the execution of the term sheet with
Lees. 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 statements concerning the execution and timing of a definitive license agreement with Lees, the future development and commercialization of the Companys product candidates and the future payment of milestone payments
or royalties to the Company. 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 Companys 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 Companys business, including, without limitation, the risk that the
Company is unable to negotiate and enter into the definitive license agreement with Lees on satisfactory terms or at all, in which case the Company could be required to refund the $200,000 up-front payment received from Lees, the risk
that the milestone payments and royalties described in the this report may not be triggered, the risk that Lees 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 Companys product candidates do not demonstrate safety and/or efficacy in clinical trials; risks related to the Companys ability to obtain financing to support its operations on commercially reasonable terms; the
progress, timing or success of the Companys clinical trials; difficulties or delays in development, testing, obtaining regulatory approval for producing and marketing the Companys product candidates; regulatory developments; the size and
growth potential of the markets for the Companys product candidates and its ability to serve those markets; the scope and validity of patent protection for the Companys product candidates; competition from other pharmaceutical or
biotechnology companies; and other risks described in the Companys 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, 2010, filed with the SEC on March 31, 2011, 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
Companys 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
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Exhibit
Number
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Description
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99.1
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Press Release, dated March 27, 2012.
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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.
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REGENERX BIOPHARMACEUTICALS, INC.
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By:
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/s/ J.J. Finkelstein
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J.J. Finkelstein
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President and Chief Executive Officer
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Date: March 30, 2012
EXHIBIT INDEX
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Exhibit
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Description
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99.1
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Press Release, dated March 27, 2012.
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