OFFERING
PROSPECTUS
10,551,471
Shares of Common Stock
5,404,412
Shares Issuable upon the Exercise of Warrants
This prospectus supplement updates and supplements the prospectus
dated August 3, 2016 (the “Prospectus”), which forms a part of our Registration Statement on Form S-1 (Registration
No. 333-212606) (the “Registration Statement”). This prospectus supplement is being filed to update and supplement
the information in the Prospectus, with the information contained in our periodic report on Form 8-K filed with the Securities
and Exchange Commission (the “Commission”) on March 5, 2019 (the “Periodic Report”). Accordingly, we have
attached the Periodic Report, with exhibits, to this prospectus supplement.
This prospectus supplement relates to the offer and sale of
10,551,471 shares of our common stock, including 5,404,412 shares of our common stock that are issuable upon the exercise of outstanding
warrants, including 257,353 shares issuable upon exercise of an outstanding warrant issued to Maxim Group LLC (“Maxim”),
the placement agent in the private offering in which the remaining shares being registered by the Registration Statement were issued.
This prospectus supplement should be read in conjunction with
the Prospectus, which is to be delivered with this prospectus supplement. This prospectus supplement updates and supplements the
information in the Prospectus. If there is any inconsistency between the information in the Prospectus and this prospectus supplement,
you should rely on the information in this prospectus supplement.
Our common stock is quoted on the OTCQB under the trading symbol
“RGRX.” On March 5, 2019, the last reported sale price of our common stock was $0.19 per share.
Investing in our securities involves a high degree of risk.
You should review carefully the risks and uncertainties described under the heading “Risk Factors” beginning on page
10 of the Prospectus, and under similar headings in any further amendments or supplements to the Prospectus before you decide whether
to invest in our securities.
Neither the Commission nor any state securities commission
has approved or disapproved of these securities or determined if the Prospectus or this prospectus supplement is truthful or complete.
Any representation to the contrary is a criminal offense.
The date of this prospectus supplement is
March 5, 2019.
UNITED STATES
SECURITIES AND EXCHANGE COMMISSION
WASHINGTON, DC 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): February 27, 2019
REGENERX BIOPHARMACEUTICALS, INC.
(Exact Name of Registrant as Specified in
its Charter)
|
Delaware
(State or Other Jurisdiction
of Incorporation)
|
|
001-15070
(Commission
File Number)
|
|
52-1253406
(IRS Employer
Identification No.)
|
|
15245 Shady Grove Road, Suite 470,
Rockville, MD
(Address of Principal Executive Offices)
|
|
20850
(Zip Code)
|
Registrant’s telephone number, including
area code:
(301) 208-9191
(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
(
see
General Instruction A.2. below):
|
|
¨
|
Written communications pursuant to Rule 425 under
the Securities Act (17 CFR 230.425)
|
|
|
¨
|
Soliciting material pursuant to Rule 14a-12 under
the Exchange Act (17 CFR 240.14a-12)
|
|
|
¨
|
Pre-commencement communications pursuant to Rule 14d-2(b)
under the Exchange Act (17 CFR 240.14d-2(b))
|
|
|
¨
|
Pre-commencement communications pursuant to Rule 13e-4(c)
under the Exchange Act (17 CFR 240.13e-4(c))
|
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 the
registrant has elected not to use the extended transition period for complying with any new or revised financial 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 February 27, 2019, RegeneRx Biopharmaceuticals,
Inc. (the “
Company
”) completed a private placement of convertible notes (the “
Notes
”) with
nine accredited investors (each, an “
Investor
,” collectively, the “
Investors
”), raising an
aggregate of $1,300,000 in gross proceeds, that will be payable in two tranches -- $650,000 received within two days of closing
of the financing on February 27, 2019 and $650,000 to be received upon enrollment of the first patient into the trial anticipated
in the first quarter of 2019. 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 $0.12 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 10,833,333 shares of our common stock. In connection with the issuance
of the Notes, the Investors also received warrants to purchase 8,125,000 shares of our common stock at an exercise price of $0.18
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 four other members of the board of directors
of the Company, Allan L. Goldstein, the Company’s Chairman and chief scientific officer, Joseph C. McNay, Don Elsey and Mauro
Bove. The principal amounts of their respective Notes are as set forth below:
|
Investor
|
Note Principal
|
|
Joseph C. McNay
|
$25,000
|
|
Allan L. Goldstein
|
$5,000
|
|
J.J. Finkelstein
|
$25,000
|
|
Don Elsey
|
$5,000
|
|
Mauro Bove
|
$10,000
|
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 over the next 12 months. 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 3.03 Material Modification of Rights
of Security Holders.
On March 2, 2018, the Company entered into
a warrant reprice and exercise and issuance agreement (the “
Reprice Agreement
”) with Sabby Healthcare Master
Fund, Ltd., and Sabby Volatility Warrant Master Fund, Ltd. (collectively, “
March 2018 Investor
”). In connection
with the Reprice Agreement, the Company issued to the March 2018 Investor warrants to purchase shares of the Company’s common
stock (the “
March Warrants
”). The exercise price under the March Warrants is subject to a limited anti-dilution
provision, such that in the event the Company makes an issuance of common stock (subject to customary exceptions) at a price per
share less than the applicable exercise price of the March Warrants, the exercise price of the March Warrants will be reduced to
the price per share applicable to such new issuance but will not adjust to an exercise price below $0.125. As a result of
the issuance of the Notes and Warrants described in Item 3.02 above, the exercise price of the March Warrants was adjusted to $0.125
per share.
Item 8.01 Other Events.
On February 27, 2019 the Company issued
a press release announcing its entry into the Reprice Agreement. 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 February 27, 2019
|
|
|
|
|
EXHIBIT INDEX
|
Exhibit No.
|
|
Description
|
|
|
|
|
|
99.1
|
|
Press Release dated February, 2019
|
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 $1.3 Million Convertible
Debt Financing
Funding
for Operations Over Next 12 Months During Phase 3 Ophthalmic Trials
ROCKVILLE, Md. (February 27, 2019) –
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 $1.3 million
convertible debt financing. The funds will be used for operations over the next approximately 12 months while a phase 3 dry eye
trial (ARISE-3), phase 3 neurotrophic keratitis trial (SEER-1), and epidermolysis bullosa open study are being conducted by its
partner and licensee.
The Company will receive $1.3 million in
two tranches – $650,000 received within two days of closing of the financing on February 27, 2019 and $650,000 to be received
upon enrollment of the first patient into the trial expected in the first quarter of 2019. The 5-year unregistered convertible
notes carry a 5% simple interest rate that accrues during the term. The note is convertible into 10,833,333 of RGRX common stock
at $0.12 per share. As part of the transaction, the note holders received 8,125,000 warrants to purchase RGRX common stock at a
price of $0.18 per share. There were no brokerage fees associated with this transaction.
“This recent financing demonstrates
continued support from our affiliates, strategic partners, management and board of directors and provides RegeneRx with essential
funding while three important clinical trials are being conducted over the next twelve months,” stated J.J. Finkelstein,
president and chief executive officer of RegeneRx. “We strongly believe in the potential of our drug candidates, which address
large, rapidly growing markets and small orphan markets where better products are desperately needed and are diligently moving
forward toward the goal of marketing approvals in the U.S. and abroad.”
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 and dermal indications, three active
strategic licensing agreements in the U.S., China, and Pan Asia (Korea, Japan, and Australia, among others), and has patents and
patent applications covering its products in many countries throughout the world.
RegeneRx, through its U.S joint venture, ReGenTree LLC, sponsored
its second Phase 3 clinical trial (ARISE-2) in approximately 600 patients with dry eye syndrome (DES) and reported positive clinical
results with no safety issues. ReGenTree recently initiated ARISE-3, a follow-up Phase 3 trial in 700 patients with DES designed
to confirm the positive results from ARISE-2. ReGenTree is also sponsoring a 46-patient Phase 3 clinical trial in patients with
neurotrophic keratopathy (NK). Additionally, RGN-259 is being developed in patients with dry eye syndrome in Asia through RegeneRx’s
two Asian partnerships. RGN-259 has been designated an orphan drug in the U.S. for the treatment of NK.
RGN-352, the Company's Tβ4-based injectable formulation,
is a Phase 2-ready drug candidate designed to be administered systemically to prevent and repair cardiac damage resulting from
heart attacks and central nervous system tissue disorders such as peripheral neuropathy, multiple sclerosis and traumatic brain
injuries such as stroke. It may also have applications in patients with severe septic shock.
RGN-137, also designated an orphan drug in the U.S., is the
Company’s Tβ4-based dermal gel formulation that is being developed for epidermolysis bullosa, a rare skin condition.
The Company’s licensee, GtreeBNT, has initiated a small, open clinical trial in the U.S. for this indication.
For additional information about RegeneRx please visit
www.regenerx.com
.