8-K

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): October 15, 2020

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))

Securities registered pursuant to Section 12(b) of the Act:

Title of each class	Trading Symbol(s)	Name of each exchange on which registered
Common	RGRX	OTC

Indicate by check mark whether the registrant is an emerging growth company as defined in Rule 405 of the Securities Act of 1933 (§230.405 of this chapter) or Rule 12b-2 of the Securities Exchange Act of 1934 (§240.12b-2 of this chapter).

Emerging Growth Company ¨

If an emerging growth company, indicate by check mark if registrant has elected not to use the extended transition period for complying with any new or revised accounting standards provided pursuant to Section 13(a) of the Exchange Act. ¨

Item 1.01 Entry into a Material Definitive Agreement.

The information set forth in Item 3.02 is incorporated by reference herein.

Item 2.03 Creation of a Direct Financial Obligation or an Obligation under an Off-Balance Sheet Arrangement of a Registrant.

The information set forth in Item 3.02 is incorporated by reference herein.

Item 3.02 Unregistered Sales of Equity Securities.

Private Placement of Convertible Notes and Warrants

On October 15, 2020 RegeneRx Biopharmaceuticals, Inc. (the “Company”) commenced closing on a private placement of convertible notes (the “Notes”) with accredited investors (each, an “Investor,” collectively, the “Investors”) that concluded on October 20, 2020, raising an aggregate of $500,000 in gross proceeds.   The Notes were issued pursuant to a Convertible Note and Warrant Purchase Agreement (the “Security Purchase Agreement”), between the Company and the Investors.

Convertible Promissory Notes and Warrants.  The key terms of the Notes are summarized below.  The Notes will pay interest at a rate of 5% per annum, mature 60 months after their date of issuance and are convertible into shares of our common stock at a conversion price of $0.36 per share (subject to adjustment as described in the Notes) at any time prior to repayment, at the election of the Investor.  In the aggregate, the Notes are initially convertible into up to 1,391,982 shares of our common stock.  In connection with the issuance of the Notes, the Investors also received warrants to purchase 1,043,987 shares of our common stock at an exercise price of $0.45 per share.

At any time prior to maturity of the Notes, with the consent of the holders of a majority in interest of the Notes, we may prepay the outstanding principal amount of the Notes plus unpaid accrued interest without penalty.  Upon the commission of any act of bankruptcy by the Company, the execution by the Company of a general assignment for the benefit of creditors, the filing by or against the Company of a petition in bankruptcy or any petition for relief under the federal bankruptcy act or the continuation of such petition without dismissal for a period of 90 days or more, or the appointment of a receiver or trustee to take possession of the property or assets of the Company, the outstanding principal and all accrued interest on the Notes will accelerate and automatically become immediately due and payable.

Investors. The Investors in the offering included our President, Chief Executive Officer and director, JJ Finkelstein; and two other members of the board of directors of the Company, Allan L. Goldstein, the Company’s Chairman and chief scientific officer, and Mauro Bove; and Essetifin SPA, the Company’s largest shareholder, investing through its affiliates.

The principal amounts of their respective Notes are as set forth below:

Investor	Note Principal
Allan L. Goldstein	$5,000
J.J. Finkelstein	$10,000
Mauro Bove	$10,000
Essetifin SPA*	$400,000

*Through its various affiliates

Use of Proceeds.   Based on current estimates, we anticipate that our existing financial resources, including the net proceeds from this offering, will be adequate to continue to conduct our business  at least through the first quarter of 2021.   We will need to raise additional capital prior to the maturity date to repay the Notes and to continue operating our business.

Securities Act Exemption.  The offering was exempt from registration under the Securities Act of 1933, as amended (the “Securities Act”) in accordance with Section 4(a)(2) under the Securities Act and Rule 506 promulgated thereunder as an offering made solely to “accredited investors” as defined under the Securities Act.  The Company obtained representations and warranties from the Investors in the Security Purchase Agreement to support the Company’s reliance on this exemption.

Item 8.01 Other Events.

On October 21, 2020, the Company issued a press release announcing the closing of the private placement. A copy of the press release is attached as Exhibit 99.1 hereto and incorporated by reference herein.

Item 9.01 Financial Statements and Exhibits.

(d) Exhibits.

Exhibit No.	Description
99.1	Press Release dated October 21, 2020

SIGNATURES

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 hereunto duly authorized.

	REGENERX BIOPHARMACEUTICALS, INC.
Date: October 21, 2020	By:	/s/ J.J. Finkelstein
		Name:	J.J. Finkelstein
		Title:	Chief Executive Officer

EX-99.1

Exhibit 99.1 

RegeneRx Biopharmaceuticals Inc. 15245 Shady Grove Road, Suite 470 Rockville, Maryland 20850   PHONE 301.208.9191 FAX 301.208.9194 WEB www.regenerx.com 

News Release

RegeneRx Closes Convertible Debt Financing

ROCKVILLE, Md. (October 21, 2020) – RegeneRx Biopharmaceuticals, Inc. (OTCQB: RGRX) (“the Company” or “RegeneRx”), a clinical-stage drug development company focused on tissue protection, repair and regeneration, today announced that it has completed a $500,000 convertible debt financing. The funds will be used for operations while awaiting completion of its phase 3 dry eye clinical trial (ARISE-3) in December and sponsored by its U.S. joint venture, ReGenTree, LLC.

The 5-year unregistered convertible notes carry a 5% simple interest rate that accrues during the term. The note is convertible into 1,391,982 shares of RGRX common stock at $0.36 per share. As part of the transaction, the note holders received warrants to purchase 1,043,987 shares of RGRX common stock at a price of $0.45 per share. There were no brokerage fees associated with the transaction.

“This limited financing demonstrates continued support from our affiliates, management and board of directors, among others, and provides RegeneRx with essential funding with minimal dilution to our stockholders while we await the results of ARISE-3. We look forward to reporting the results as soon as practicable after completion of the trial in December,” stated J.J. Finkelstein, president and chief executive officer of RegeneRx.

The securities offered in the private placement have not been registered under the Securities Act, or any state securities law. Unless the shares, warrants and shares underlying the warrants are registered, they may not be offered or sold in the United States except pursuant to an exemption from the registration requirements of the Securities Act and applicable state laws. This press release shall not constitute an offer to sell or the solicitation of an offer to buy such common stock or warrants.

About RegeneRx Biopharmaceuticals, Inc. (www.regenerx.com)

RegeneRx is focused on the development of novel therapeutic peptides, including Thymosin beta 4 (Tβ4) and its constituent fragments, for tissue and organ protection, repair, and regeneration. RegeneRx currently has three drug candidates in clinical development for ophthalmic, cardiac/TBI and dermal indications, four active strategic licensing agreements in the U.S., China, and Pan Asia (Korea, Japan, and Australia, among others), and the EU, and has patents and patent applications covering its products in many countries throughout the world. RGN-259, the Company’s ophthalmic eye drop, is currently in phase 3 development in the U.S. for dry eye syndrome and neurotrophic keratitis. The Company is also considering initiating a program to evaluate RGN-352, an injectable formulation of Tβ4 for the treatment of patients with COVID-19, if it is able to obtain the requisite funding. The Company previously successfully completed phase 1 with RGN-352.

Forward-Looking Statements

Any statements in this press release that are not historical facts are forward-looking statements made under the provisions of the Private Securities Litigation Reform Act of 1995. Any forward-looking statements involve risks and uncertainties that could cause actual results to be materially different from historical results or from any future results expressed or implied by such forward-looking statements. Forward-looking statements in this press release include, but are not limited to, financial condition, use of proceeds from this financing, competitive products, status and outcomes of clinical trials, regulatory applications and approvals, the development and value of our drug candidates, and the use of our drug candidates to treat various conditions. All forward-looking statements are expectations and estimates based upon information obtained and calculated by the Company at this time and are subject to change. Moreover, there is no guarantee any clinical trial will be successful and confirm previous clinical results. Please view these 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, 2019, 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 shareholder letter represent the Company’s views only as of the date of this release and should not be relied upon as representing its views as of any subsequent date. The Company specifically disclaims any obligation to update this information, as a result of future events or otherwise, except as required by applicable law.

For RegeneRx:

Lori Herman

301.208.9191

las@regenerx.com