NRX Pharmaceuticals, Inc 8-K, filed May 26, 2021
NRX Pharmaceuticals, Inc. (NRXP)
About this 8-K
NRX Pharmaceuticals, Inc filed this 8-K on May 26, 2021, reporting on events of May 24, 2021.
Items reported
- Item 5.07: Shareholder vote results
- Item 7.01: Regulation FD disclosure
- Item 9.01: Financial statements and exhibits
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): May 24, 2021
NRX PHARMACEUTICALS, INC.
(Exact Name of Registrant as Specified in Charter)
| Delaware | 001-38302 | 82-2844431 | ||
| (State or Other Jurisdiction of Incorporation) |
(Commission File Number) |
(IRS Employer Identification No.) | ||
| 1201 Orange Street, Suite 600, Wilmington, Delaware | 19801 | |||
| (Address of Principal Executive Offices) | (Zip Code) | |||
Registrant’s telephone number, including area code: (484) 254-6134
Big Rock Partners Acquisition Corp.
2645 N. Federal Highway, Suite 230
Delray Beach, FL 33483
(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)) |
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, each whole warrant exercisable for one share of Common Stock at an exercise price of $11.50 | 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 5.07. Submission of Matters to a Vote of Security Holders
On May 24, 2021, NRX Pharmaceuticals, Inc., a Delaware corporation (formerly known as Big Rock Partners Acquisition Corp., “BRPA”), held an annual meeting of stockholders (“Meeting”), by means of live audio webcast, which was called to approve the proposals relating to the entry into and consummation of the Agreement and Plan of Merger, dated as of December 13, 2020 (as amended, the “Merger Agreement”), by and among BRPA, NeuroRx, Inc., a Delaware corporation (“NeuroRx”), and Big Rock Merger Corp., a Delaware corporation and wholly-owned subsidiary of BRPA (“Merger Sub”). An aggregate of 2,135,500 shares of BRPA common stock, which represents a quorum of the outstanding common stock entitled to vote on the record date of April 23, 2021, were represented at the Meeting in person (which includes presence at the virtual meeting) or by proxy.
BRPA’s stockholders voted on the following proposals at the Meeting, each of which was approved:
(1) Proposal No. 1 — The Business Combination Proposal – To approve and adopt the Merger Agreement, and the transactions contemplated therein, including the merger of Merger Sub with and into NeuroRx, Inc. The following is a tabulation of the votes with respect to this proposal, which was approved by BRPA’s stockholders:
| For |
Against |
Abstain |
Broker Non-Votes | |||
| 2,135,500 | 0 | 0 | 0 |
BRPA’s public stockholders who wish to exercise conversion rights must demand conversion no later than ten (10) business days following the Meeting date by tendering their shares to Continental Stock Transfer & Trust Company, BRPA’s transfer agent, by either physically delivering share certificates to the transfer agent or by delivering shares electronically using the transfer agent’s DWAC (Deposit Withdrawal at Custodian) system.
(2) Proposal No. 2 — The Charter Proposals – To approve amendments to BRPA’s current amended and restated certificate of incorporation, which amendments will be effective following the consummation of the business combination and will be embodied in a second amended and restated certificate of incorporation of BRPA (the “Proposed Charter”) to:
a. Change the name of BRPA from “Big Rock Partners Acquisition Corp.” to “NRX Pharmaceuticals, Inc.” The following is a tabulation of the votes with respect to this proposal, which was approved by BRPA’s stockholders:
| For |
Against |
Abstain |
Broker Non-Votes | |||
| 2,135,500 | 0 | 0 | 0 |
b. Increase the number of authorized shares of Common Stock from 100,000,000 shares to 500,000,000 shares. The following is a tabulation of the votes with respect to this proposal, which was approved by BRPA’s stockholders:
| For |
Against |
Abstain |
Broker Non-Votes | |||
| 2,135,500 | 0 | 0 | 0 |
c. Increase the authorized shares of preferred stock from 1,000,000 to 50,000,000. The following is a tabulation of the votes with respect to this proposal, which was approved by BRPA’s stockholders:
| For |
Against |
Abstain |
Broker Non-Votes | |||
| 2,135,500 | 0 | 0 | 0 |
d. Require an affirmative vote of holders of at least two-thirds (66 2/3%) of the voting power of all of the then outstanding shares of voting stock of NRX Pharmaceuticals following the consummation of the business combination, voting together as a single class, to amend, alter, repeal or rescind certain provisions of the Proposed Charter relating to the authorization and issuance of preferred stock, the board of directors, stockholder actions, liability of directors, indemnification of directors and officers, forum selection and amendments to the Proposed Charter. The following is a tabulation of the votes with respect to this proposal, which was approved by BRPA’s stockholders:
| For |
Against |
Abstain |
Broker Non-Votes | |||
| 2,135,500 | 0 | 0 | 0 |
e. Provide for the removal of directors with cause only by stockholders voting at least three-quarters (75%) of the voting power of all of the then outstanding shares of voting stock of NRX Pharmaceuticals entitled to vote at an election of directors. The following is a tabulation of the votes with respect to this proposal, which was approved by BRPA’s stockholders:
| For |
Against |
Abstain |
Broker Non-Votes | |||
| 2,135,500 | 0 | 0 | 0 |
f. Remove the various provisions applicable only to special purpose acquisition companies. The following is a tabulation of the votes with respect to this proposal, which was approved by BRPA’s stockholders:
| For |
Against |
Abstain |
Broker Non-Votes | |||
| 2,135,500 | 0 | 0 | 0 |
(3) Proposal No. 3 — The Bylaws Proposal – To approve amendments to BRPA’s amended and restated bylaws, which amendments will be effective following the consummation of the Transactions and be embodied in a second amended and restated bylaws of BRPA (the “ (the “Proposed Bylaws”), including to no longer require the affirmative vote of the holders of at least 66.7% of the issued and outstanding capital stock of BRPA to amend certain provision of the Proposed Bylaws and provide that the board of directors of NRX Pharmaceuticals be expressly empowered to adopt, amend or repeal the bylaws of NRX Pharmaceuticals. The following is a tabulation of the votes with respect to this proposal, which was approved by BRPA’s stockholders:
| For |
Against |
Abstain |
Broker Non-Votes | |||
| 2,135,500 | 0 | 0 | 0 |
(4) Proposal No. 4 — The Nasdaq Proposals – To approve separate proposals, as required by the rules of the Nasdaq Stock Market, to:
a. Approve the issuance of an aggregate of 75,200,000 shares of Common Stock to the securityholders of NeuroRx and to EBC in the Transactions. The following is a tabulation of the votes with respect to this proposal, which was approved by BRPA’s stockholders:
| For |
Against |
Abstain |
Broker Non-Votes | |||
| 2,135,500 | 0 | 0 | 0 |
b. Approve the issuance of Common Stock to the securityholders of NeuroRx resulting in a change of control of BRPA. The following is a tabulation of the votes with respect to this proposal, which was approved by BRPA’s stockholders:
| For |
Against |
Abstain |
Broker Non-Votes | |||
| 2,135,500 | 0 | 0 | 0 |
c. Approve the issuance of an aggregate of 1,000,000 shares of Common Stock to the Investors in the PIPE. The following is a tabulation of the votes with respect to this proposal, which was approved by BRPA’s stockholders:
| For |
Against |
Abstain |
Broker Non-Votes | |||
| 2,135,500 | 0 | 0 | 0 |
(5) Proposal No. 5 — The Director Proposal — To elect six (6) directors to the board of directors of BRPA to serve following the consummation of the Transactions. The following is a tabulation of the votes with respect to each director elected at the Meeting:
| Director | For | Withheld | Broker Non- Vote |
|||||||||
| Class I |
||||||||||||
| Chaim Hurvitz |
2,135,500 | 0 | 0 | |||||||||
| Daniel Troy |
2,135,500 | 0 | 0 | |||||||||
| Class II |
||||||||||||
| Sherry Glied |
2,135,500 | 0 | 0 | |||||||||
| Aaron Gorovitz |
2,135,500 | 0 | 0 | |||||||||
| Class III |
||||||||||||
| Patrick Flynn |
2,135,500 | 0 | 0 | |||||||||
| Jonathan Javitt |
2,135,500 | 0 | 0 | |||||||||
(6) Proposal No. 6 — The Plan Proposal – To approve the 2021 Long-Term Incentive Equity Plan. The following is a tabulation of the votes with respect to this proposal, which was approved by BRPA’s stockholders:
| For |
Against |
Abstain |
Broker Non-Votes | |||
| 2,135,500 | 0 | 0 | 0 |
Because each of the foregoing proposals were approved and because BRPA and NeuroRx did not require additional time to complete the business combination, the proposal to adjourn the Meeting to a later date or dates, if necessary, was not presented at the Meeting.
Item 7.01. Regulation FD Disclosure.
On May 24, 2021, BRPA and NeuroRx issued a press release announcing the completion of the transactions contemplated by the Merger Agreement. The press release is attached as Exhibit 99.1 hereto.
The information set forth under this Item 7.01, including the exhibit hereto, is intended to be furnished and shall not be deemed “filed” for purposes of Section 18 of the Securities Exchange Act of 1934, as amended (“Exchange Act”) or otherwise subject to the liabilities of that section, nor shall it be deemed incorporated by reference in any filing under the Securities Act of 1933, as amended (“Securities Act”) or the Exchange Act, except as expressly set forth by specific reference in such filing.
Item 9.01 Financial Statements and Exhibits.
(d) Exhibits:
| Exhibit |
Description | |
| 99.1 | Press release, dated May 25, 2021. | |
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 hereunto duly authorized.
| NRX PHARMACEUTICALS, INC. | ||||||
| Dated: May 26, 2021 | By: | /s/ Alessandra Daigneault | ||||
| Name: | Alessandra Daigneault | |||||
| Title: | General Counsel and Corporate Secretary | |||||
Exhibit 99.1
NRx Pharmaceuticals, Inc. Commences Trading on Nasdaq as NRXP, Following Merger
Between NeuroRx, Inc. and Big Rock Partners Acquisition Corp (Nasdaq:BRPA)
| • | Newly formed publicly traded company NRx Pharmaceuticals, Inc. (NRx) to be traded under the ticker symbol “NRXP” on the Nasdaq Global Market |
| • | NRx is dedicated to its mission of “Bringing Hope to Life” through the development of innovative medicines for life-threatening, unmet medical needs |
| • | NRx to seek FDA Emergency Use Authorization for ZYESAMI™ (Aviptadil acetate) to treat critically-ill patients with Covid-19 respiratory failure. ZYESAMI™ is currently the subject of a global phase III trial sponsored by the U.S. National Institutes of Health |
| • | NRX-101 is the only investigational medicine granted U.S. Food and Drug Administration (FDA) Breakthrough Therapy Designation for treating Suicidal Bipolar Depression |
RADNOR, Pa., May 25, 2021 /PRNewswire/ — Today, NeuroRx, Inc., announced it has been approved by the Nasdaq for listing on the Nasdaq Global Market, following the completion of its business combination with Big Rock Partners Acquisition Corp. (Nasdaq: BRPA). The combined entity is NRx Pharmaceuticals, Inc. and will trade on the Nasdaq Global Market as NRXP.
“Today marks a major milestone as we include public investors in our quest to bring innovative medicines to patients at immediate risk of death, who have no currently-approved medicinal therapies. We live by our credo of “Bringing Hope to Life,” said Professor Jonathan Javitt, MD, MPH, Founder, CEO and Chairman of the Board, of NRx. “We are indebted to the leaders and shareholders of BRPA who have chosen to support our mission.”
NRx Pharmaceuticals, Inc. Commences Trading on Nasdaq as NRXP
As a Nasdaq-listed company, NRx will deploy public capital to continue development of two investigational medicines: ZYESAMI™, (Aviptadil acetate) the first FDA Fast Track-designated investigational medicine, being studied in critically-ill patients with COVID-19 induced respiratory failure, and NRX-101 (a combination drug therapy of D-cycloserine and lurasidone), the first investigational medicine to receive FDA Breakthrough Therapy Designation for patients with suicidal bipolar depression. ZYESAMI™ has demonstrated a statistically significant increase in the likelihood of survival and recovery from respiratory failure in a phase 2b/3 trial (co-funded with Relief Therapeutics (SIX:RLF,OTCBB:RLFTF) of critically-ill patients with COVID-19.1,2 These advantages were previously reported in an open label trial of critically-ill patients at the Houston Methodist Hospital.3 The company expects to seek Emergency Use Authorization of ZYESAMI™ from the FDA in May 2021.
NRX-101 is based on the inventions and innovation of Prof. Daniel Javitt, MD, PHD, who first explained the impact of the brain’s NMDA receptor in schizophrenia and other psychiatric diseases. NRX-101 has demonstrated a statistically-significant advantage in maintaining remission from depression after initial treatment with ketamine in a phase 2 study.4 Currently, the only FDA-approved treatment for suicidal bipolar depression is electroshock therapy.
Both investigational medicines (ZYESAMI™ and NRX-101) are now in FDA-approved phase 3 clinical trials. The trial of ZYESAMI™ is being conducted by the National Institutes of Health (ACTIV3b/TESICO) at leading medical centers around the world.5 A second trial is being conducted on the I-SPY platform with the support of the Biomedical Advanced Research Development Authority (BARDA) of the US Department of Health and Human Services. The trial of NRX-101 is being led by investigators at Harvard/Mass General, University of Alabama Birmingham, and Baylor College of Medicine.6
Jonathan Javitt, MD, MPH leads NRx as CEO and Chairman of the Board. He is joined by directors and executives who have served in global leadership executive roles in the pharmaceutical industry for decades. The company’s directors include Dr. Sherry Glied, former Assistant Secretary at the U.S. Department of Health and Human Services, Chaim Hurvitz, former President and Director of Teva and Daniel Troy, former Chief Counsel to the U.S. FDA.
NRx has committed operating capital in excess of $120 million from cash on hand, the PIPE funding disclosed in the company’s S-4 filing, exercise of warrants by the Global Emerging Markets (GEM) Global Yield Fund, and a Share Subscription Facility (also disclosed in the S-4) provided by GEM. Additional funds may be provided by the trust fund of BRPA and through exercise of publicly-held warrants to purchase BRPA (now NRXP) shares, dependent on the individual investment decisions of trust-fund holders and warrant holders.
“NRx has dedicated itself to patients whose lives depend upon new, innovative medicines and whose needs have not been addressed by major pharmaceutical companies,” said the Honorable Sherry Glied, PhD, former Assistant Secretary for Planning and Evaluation at the U.S. Department of Health and Human Services, and member of the NRx Board of Directors. “The NRx leadership team draws upon more than 100 collective years of pharmaceutical development, science and business expertise to bring Breakthrough Therapies to the market.”
About NRx Pharmaceuticals
NRX Pharmaceuticals, Inc. (Nasdaq: NRXP) (NRx) is a patient-focused, clinical stage pharmaceutical company, drawing upon more than 100 years of collective medicine development experience. NRx creates therapies to treat diseases where no medicines currently exist.
NRx expects to seek Emergency Use Authorization from the U.S. Food and Drug Administration (FDA) to treat Critical Covid-19 in patients suffering respiratory failure in May 2021. In addition, the FDA recently granted Breakthrough Therapy Designation and a Special Protocol Agreement to develop NRX-101 in suicidal bipolar depression. NRX-101 is currently in Phase 3 trials, with data readouts expected in the first half of 2022.
Cautionary Note Regarding Forward Looking Statements
This press release 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. Words such as “expect,” “anticipate,” “should,” “believe,” “hope,” “target,” “project,” “goals,” “estimate,” “potential,” “predict,” “may,” “will,” “might,” “could,” “would,” “seek,” “plan,” “intend,” “shall,” and variations of these terms or the negative of these terms and similar expressions are intended to identify these forward-looking statements. These forward-looking statements are, by their nature, subject to significant risks and uncertainties, many of which involve factors or circumstances that are beyond the company’s control. These risks and uncertainties include, but are not limited to, our relatively limited operating history; our ability to expand, retain and motivate our employees and manage our growth; risks associated with general industry conditions and competition; general economic factors, including interest rate and currency exchange rate fluctuations; the impact of the global outbreak of the novel coronavirus disease (COVID-19); the impact of pharmaceutical industry regulation and health care legislation in the United States and internationally; global trends toward health care cost containment; technological advances, new products and patents attained by competitors; challenges inherent in new product development, including obtaining regulatory approval; the company’s ability to accurately predict future market conditions; manufacturing difficulties or delays; changes in laws, rules or regulations relating to any aspect of the company’s business operations, or general economic, market and business conditions; financial instability of international economies and sovereign risk; dependence on the effectiveness of the company’s patents and other protections for innovative products; and the exposure to litigation, including patent litigation, and/or regulatory actions. Furthermore, there can be no guarantees with respect to pipeline products that the products will receive the necessary regulatory approvals or that they will prove to be commercially successful. If underlying assumptions prove inaccurate or risks or uncertainties materialize, actual results may differ materially from those set forth in the forward-looking statements. The company assumes no obligation and does not intend to update or otherwise revise any forward looking statement, whether as a result of new information, future events or otherwise, except as required by applicable law. As a result of these and other risks, uncertainties and assumptions, forward-looking events and circumstances discussed herein might not occur in the way that the company’s management expects, if at all. 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.
Media and Investor Contact
Jack Hirschfield
Sr. Director, External Affairs, NRx
jhirschfield@nrxpharma.com
512-674-5163
| 1 | Javitt, JC, Intravenous Aviptadil for Critical COVID-19 With Respiratory Failure (COVID-AIV). Identifier NCT04311697. https://clinicaltrials.gov/ct2/show/NCT04311697 |
| 2 | Youssef, JG,Lee, R, Javitt, JC, et. Al., Increased Recovery and Survival in Patients With COVID-19 Respiratory Failure Following Treatment with Aviptadil: Report #1 of the ZYESAMI COVID-19 Research Group (April 23, 2021). Available at http://dx.doi.org/10.2139/ssrn.3830051 |
| 3 | Youssef, JG, et al., VIP in the Treatment of Critical COVID-19 With Respiratory Failure in Patients with Severe Comorbidity: A Prospective Externally-Controlled Trial (October 25, 2020). Available at http://dx.doi.org/10.2139/ssrn.3665228 |
| 4 | Nierenberg, A., & Javitt, J.C. (2016, Nov 28 - 2018, Dec 11). Sequential Therapy for the Treatment of Severe Bipolar Depression. (STABIL-B). Identifier NCT02974010. https://clinicaltrials.gov/ct2/show/NCT02974010 |
| 5 | Brown, S. & Neaton, J. (2021, April 14 ). ACTIV-3b: Therapeutics for Severely Ill Inpatients With COVID-19 (TESICO). Identifier NCT04843761. https://clinicaltrials.gov/ct2/show/NCT04843761 |
| 6 | Nierenberg, A., & Javitt, J.C. (2016, Nov 28 - 2018, Dec 11). Sequential Therapy for the Treatment of Severe Bipolar Depression. (STABIL-B). Identifier NCT02974010. https://clinicaltrials.gov/ct2/show/NCT02974010 |