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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)
February 7, 2024
NRX PHARMACEUTICALS, INC.
(Exact name of registrant as specified in its charter)
Delaware |
|
001-38302 |
|
82-2844431 |
(State or other jurisdiction
of incorporation) |
|
(Commission
File Number) |
|
(I.R.S. Employer
Identification No.) |
1201 Orange Street,
Suite 600
Wilmington, Delaware |
|
19801 |
(Address of principal executive offices) |
|
(Zip Code) |
(484) 254-6134
(Registrant’s telephone number, including
area code)
N/A
(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:
| ¨ | 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)) |
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 Stock, par value $0.001 per share |
|
NRXP |
|
The Nasdaq Stock Market LLC |
Warrants to purchase one share of Common Stock |
|
NRXPW |
|
The Nasdaq Stock Market LLC |
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.
On February 7, 2024, NeuroRx, Inc.,
a wholly-owned subsidiary of NRx Pharmaceuticals, Inc. (together, the “Company”), entered into the First
Amendment (the “Amendment”) to the Exclusive, Global Development, Supply, Marketing & License Agreement,
dated as of June 2, 2023 (the “License Agreement”), with Alvogen Pharma US, Inc., Alvogen, Inc.
and Lotus Pharmaceutical Co. Ltd. (collectively, “Alvogen”), effective as of the same date.
Pursuant to the terms of the Amendment, the Company
will receive $5 million of the Milestone Payment (as defined in the License Agreement) in advance, which NRx will use to fund the development
of NRX-101 through the phase 2 meeting with the U.S. Food and Drug Administration (“FDA”). As compensation
for advancing such portion of the Milestone Payment, Alvogen will receive 4,195,978 warrants to purchase the Company's common stock,
at a strike price of $0.40 with a three (3) year term (the “Warrants”). The second portion of the milestone
payment, in the amount of $4 million, will be due to the Company within 60 days of Completion of the Type B Meeting (as defined in the
License Agreement).
The Company then remains eligible to receive up
to $320 million in future development and sales milestones, as well as royalty payments escalating to mid-teen percentages of annual net
sales of NRX-101, subject to achievement of certain sales volumes. Additionally, Alvogen will be responsible for future development and
commercialization costs for NRX-101 in treatment of bipolar depression with suicidality.
The foregoing is only a summary of the material
terms of the Amendment and does not purport to be complete. The foregoing summary is qualified in its entirety by reference to the complete
text of the Amendment, which will be filed at a later date.
Item 8.01 Other Events.
On February 12, 2024, the Company issued
a press release announcing its entry into the Amendment and the issuance of the Warrants. A copy of the press release is attached hereto
as Exhibit 99.1 and is incorporated herein by reference.
Item 9.01 Financial Statements and Exhibits.
(d) Exhibits
SIGNATURES
Pursuant to the requirements of the Securities
Exchange Act of 1934, as amended, the registrant has duly caused this report to be signed on its behalf by the undersigned hereunto duly
authorized.
|
NRX PHARMACEUTICALS, INC. |
|
|
Date: February 14, 2024 |
By: |
/s/ Stephen Willard |
|
Name: |
Stephen Willard |
|
Title: |
Acting General Counsel |
Exhibit 99.1
NRx Pharmaceuticals, Inc. (Nasdaq: NRXP)
Announces Advance of $5 Million Milestone Payment from Partners Alvogen, Inc. and Lotus Pharmaceutical Co. Ltd. (1975.TW)
| · | Companies continue to work collaboratively to advance NRX-101 through registrational trials |
| · | NRx remains eligible for an additional $324 million in development and sales milestones, as well as tiered double-digit royalties
upon approval and commercialization of NRX-101. |
| · | Payment materially extends the Company’s cash runway |
RADNOR, Pa., Feb. 12, 2024 /PRNewswire/ -- NRx Pharmaceuticals, Inc.
(Nasdaq: NRXP) (“NRx Pharmaceuticals”, the “Company”), a clinical-stage biopharmaceutical company, today announced
the advance of the first $5 million milestone payment based on the Company’s partnership agreement with Alvogen, Inc. and Lotus
Pharmaceutical Co. Ltd. (1975.TW).
Under the terms of the updated agreement, the Company will immediately
receive $5 million of the first milestone, which NRx will use to fund development of NRX-101 through the phase 2 meeting with FDA. As
compensation for advancing the milestone, Alvogen and Lotus will receive 4.1 million warrants to purchase the Company’s common stock,
at a strike price of $0.40 with a three (3) year term. The second portion of the milestone will be $4 million and, as before, be
triggered by a positive response to the Company’s planned end of phase 2 meeting with FDA.
NRx then remains eligible to receive up to $320 million in future development
and sales milestones, as well as royalty payments escalating to mid-teen percentages on Net Sales, subject to achievement of certain sales
volumes. Additionally, Alvogen and Lotus will be responsible for future development and commercialization costs for NRX-101 in treatment
of bipolar depression with suicidality.
“In a market environment where biotech companies have been increasingly
challenged to fund clinical development, we appreciate the confidence of partners that share our view that NMDA-antagonist drugs potentially
represent a new and potent class of medicines to treat bipolar depression with suicidality. Over the past six months, NRx, Lotus, and
Alvogen have formed a close working relationship and we share a joint commitment to bringing this potentially life-saving drug to patients.”
said Stephen Willard, Chief Executive Officer of NRx Pharmaceuticals.
Additional information can be found on the Company website’s
Investor Relations page Investor Q&A.
About NRx Pharmaceuticals
NRx Pharmaceuticals is a clinical-stage biopharmaceutical company developing
therapeutics based on its NMDA platform for the treatment of central nervous system disorders, specifically suicidal bipolar depression,
chronic pain and PTSD. The Company is developing NRX-101, an FDA-designated investigational Breakthrough Therapy for suicidal treatment-resistant
bipolar depression and chronic pain. NRx has partnered with Alvogen and Lotus around the development and marketing of NRX-101 for the
treatment of suicidal bipolar depression. NRX-101 additionally has potential to act as a non-opioid treatment for chronic pain, as well
as a treatment for complicated UTI.
NRx has recently announced plans to submit a New Drug Application for
NRX-100 (IV ketamine) in the treatment of suicidal depression, based on results of well-controlled clinical trials conducted under the
auspices of the US National Institutes of Health and newly obtained data from French health authorities, licensed under a data sharing
agreement. NRx was awarded Fast Track Designation for development of ketamine (NRX-100) by the US FDA as part of a protocol to treat patients
with acute suicidality.
Cautionary Note Regarding Forward-Looking Statements
This announcement of NRx Pharmaceuticals, Inc. includes “forward-looking
statements” within the meaning of the “safe harbor” provisions of the U.S. Private Securities Litigation Reform Act
of 1995, which may include, but are not limited to, statements regarding our financial outlook, product development, business prospects,
and market and industry trends and conditions, as well as the Company’s strategies, plans, objectives, and goals. These forward-looking
statements are based on current beliefs, expectations, estimates, forecasts, and projections of, as well as assumptions made by, and information
currently available to, the Company’s management.
The Company assumes no obligation to revise any forward-looking statement,
whether as a result of new information, future events or otherwise. Accordingly, you should not place reliance on any forward-looking
statement, and all forward-looking statements are herein qualified by reference to the cautionary statements set forth above.
For further information: Jeremy Feffer, LifeSci Advisors, Inc.,
jfeffer@lifesciadvisors.com, Matthew Duffy, Chief Business Officer, mduffy@nrxpharma.com
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