NRx Pharmaceuticals Provides Business Update and Reports Full Year 2021 Financial Results

Company to Host Conference Call and Webcast March 31, 2022, at 8:30am ET

RADNOR, Pa., March 31, 2022  /PRNewswire/ -- NRx Pharmaceuticals, Inc. (Nasdaq: NRXP) ("NRx Pharmaceuticals"), a clinical-stage, biopharmaceutical company, today announced its financial results for the year ended December 31, 2021 and provided a business update.

NRx Q4 Earnings Highlight New Leadership Team, Core-Business Focus on U.S., Zyesami and NRX 101

"NRx Pharmaceuticals was founded to address high unmet or life-threatening medical needs by applying innovative science to known molecules." said Robert Besthof, Interim Chief Executive Officer. "We are excited to continue to build upon the foundation laid by our founder and my predecessor Dr. Jonathan Javitt. Today NRx is positioned to bring hope to life by executing our strategy in two priority areas in which we have Phase III compounds with Fast Track and Breakthrough Therapy designation, respectively: the development and approval of ZYESAMI® (aviptadil), for treatment of Critical COVID-19 and other respiratory diseases, and advancing our psychiatric portfolio, including NRX-101. Given a changing global geopolitical environment we believe it is prudent to narrow our geographic focus principally in the United States and where we can make the biggest contribution towards improving patient care in the near term. We look forward to advancing the late-stage studies of our promising pipeline of Phase III candidates in Psychiatry and Respiratory Diseases and realizing their potential for patients and investors."

Recent Business Highlights
  • Announced leadership transition - Robert Besthof named Interim CEO; Dr. Jonathan Javitt to serve as Chief Scientist, member of the Board of Directors
  • Company now geographically focused primarily in the U.S. on its two Phase III assets for which it has Fast Track and Breakthrough Therapy designation, respectively: intravenous ZYESAMI® for Critical COVID-19 and NRX-101 for bipolar depression with suicidality
  • Re-initiating psychiatry development - initiating a Phase II study of NRX-101 for bipolar depression with sub-acute suicidal ideation and behavior (SSIB); plans to initiate a new Phase IIb/III registrational study of NRX-101 for severe bipolar depression with acute suicidal ideation and behavior (ASIB) using commercial level material in the second half of 2022
  • NIH ACTIV-3b Trial of intravenous ZYESAMI® reaching approximately 465 enrolled patients; ZYESAMI is now the only new investigational drug in this study for Critical COVID-19
  • I-SPY study of inhaled ZYESAMI® in Critical COVID-19 stopped; NRx inhaled study in severe COVID-19 is paused – exploring inhaled ZYESAMI® for less severe COVID-19 and other respiratory diseases in the future
  • Decision made to no longer pursue BriLife™ COVID-19 vaccine project
  • Completed $25 million private placement in February 2022
Financial Results for the Year Ended December 31, 2021
  • Research and development expenses for the year ended December 31, 2021, totaled $20.3 million, compared to $10.6 million for the year ended December 31, 2020. The increase was primarily driven by an increase in clinical trials and development expenses related to ZYESAMI®.
  • General and administrative expenses for the year ended December 31, 2021, totaled $74.9 million, of which $60.3 million were non-cash stock-based compensation, consulting fees and warrant expense. General and administrative expenses for the year ended December 31, 2020, totaled $11.4 million, of which $5.7 million was non-cash stock-based compensation, consulting fees, and warrant expense. The increase was primarily due to the increase in non-cash stock-based compensation expenses, consulting fees, and an increase in insurance expenses.
  • Settlement expense for the year ended December 31, 2021, was $21.4 million compared to $39.5 million for the year ended December 31, 2020. Settlement expense is a non-cash expense.
  • Reimbursements of expenses from Relief Therapeutics were $0.8 million for the year ended December 31, 2021, compared to $10.2 million for the year ended December 31, 2020.
  • Other income for the year ended December 31, 2021, was $22.7 million, driven primarily by a $20.9 million decrease in the earnout cash liability and a $1.7 million decrease in the warrant liability. Other expenses for the year ended December 31, 2020, were $0.4 million primarily due to a loss on conversion of convertible notes payable.
  • Net loss for the year ended December 31, 2021, was $93.1 million, or $1.98 per share, compared with a net loss of $51.8 million, or $1.51 per share for the year ended December 31, 2020.
  • Cash used in operating activities was $37.7 million for the year ended December 31, 2021, compared to $2.3 million for the year ended December 31, 2020.
  • As of December 31, 2021, cash was $27.6 million, compared to $1.9 million as of December 31, 2020. As previously mentioned, NRx completed a $25 million private placement financing in February 2022. NRx believes it has sufficient cash to support operations for at least the next 12 months.
About NRx Pharmaceuticals

NRx Pharmaceuticals, Inc. (Nasdaq: NRXP) ("NRx Pharmaceuticals" or the "Company") draws upon decades of collective, scientific, and drug-development experience to bring improved health to patients. Its investigational product, ZYESAMI® (aviptadil) for patients with COVID-19, has been granted Fast Track designation by the US Food and Drug Administration (FDA) and is in a Phase III trial for Critical COVID-19 patients which is sponsored and managed by the US National Institutes of Health. The FDA has additionally granted Breakthrough Therapy designation, a Special Protocol Agreement, and a Biomarker Letter of Support for NRX-101, an investigational medicine for the treatment of severe bipolar depression in patients with acute suicidal ideation and behavior (ASIB) after initial stabilization with ketamine or other effective therapy.

NRx Pharmaceuticals is led by executives and board members who have held senior roles at Lilly, Pfizer, GSK and the US FDA. NRx Pharmaceuticals was co-founded by Prof Jonathan Javitt, MD, MPH, who has held leadership roles in various biotechnology startup companies and been appointed to advisory roles in four U.S. Presidential Administrations. The NRx Pharmaceuticals' board includes Dr. Sherry Glied, former U.S. Assistant Secretary for Health (ASPE), Daniel E. Troy, JD, former Chief Counsel of the U.S. FDA, Chaim Hurvitz, former director of Teva and President of the Teva International Group, and General H.R. McMaster, Ph.D. (US Army, Ret.), the 26th United States National Security Advisor.

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.

CORPORATE CONTACT

INVESTOR RELATIONS

Molly Cogan

Eric Goldstein

Senior Director, Global Communications

LifeSci Advisors

mcogan@nrxpharma.com

egoldstein@lifesciadvisors.com

 

 

NRX PHARMACEUTICALS, INC.

CONSOLIDATED STATEMENTS OF OPERATIONS

(in thousands, except share and per share data)

Year ended

December 31, 

2021

2020

Operating expenses:

     Research and development

$

20,257

$

10,625

     General and administrative

74,944

11,436

     Settlement expense

21,366

39,486

     Reimbursement of expenses from Relief Therapeutics

(771)

(10,160)

   Total operating expenses

115,796

51,387

Loss from operations

(115,796)

(51,387)

Other (income) expenses:

     Gain on extinguishment of debt

(121)

     Interest expense

18

56

     Change in fair value of warrant liability

(1,692)

     Change in fair value of Earnout Cash liability

(20,938)

     Change in fair value of embedded put

27

     Loss on conversion of convertible notes payable

307

   Total other (income) expenses

(22,733)

390

Loss before tax

(93,063)

(51,777)

   Provision for income taxes

Net loss

(93,063)

(51,777)

   Deemed dividend - warrants

(2,692)

   Deemed dividend - Earnout Shares

(253,130)

Net loss attributable to common stockholders

$

(348,885)

$

(51,777)

Net loss per share:

   Basic and diluted

$

(1.98)

$

(1.51)

Net loss per share attributable to common stockholders:

   Basic and diluted

$

(7.44)

$

(1.51)

Weighted average common shares outstanding:

   Basic and diluted

46,917,701

34,270,955

 

 

 

NRX PHARMACEUTICALS, INC.

CONSOLIDATED BALANCE SHEETS

(in thousands, except share and per share data)

December 31, 

2021

2020

ASSETS

Current assets:

     Cash

$

27,605

$

1,859

     Account receivable, net of allowance of $257 as of December 31, 2020

831

     Prepaid expenses and other current assets

5,109

240

        Total current assets

32,714

2,930

     Other assets

15

11

        Total assets

$

32,729

$

2,941

LIABILITIES AND STOCKHOLDERS' EQUITY (DEFICIT)

     Current liabilities:

     Accounts payable

$

3,687

$

3,153

     Accrued and other current liabilities

2,375

1,729

     Accrued clinical site costs

469

1,547

     Earnout Cash liability

4,582

     Warrant liabilities

292

     Notes payable and accrued interest

518

249

     Accrued settlement expense

39,486

        Total current liabilities

11,923

46,164

     Notes payable and accrued interest

548

        Total liabilities

$

11,923

$

46,712

Stockholders' equity (deficit):

Common stock, $0.001 par value, 500,000,000 shares authorized; 58,810,550
and 42,973,462 shares issued and outstanding at December 31, 2021 and
2020, respectively

59

43

     Additional paid-in capital

203,990

46,366

     Accumulated deficit

(183,243)

(90,180)

        Total stockholders' equity (deficit)

20,806

(43,771)

        Total liabilities and stockholders' equity (deficit)

$

32,729

$

2,941

 

 

 

NRX PHARMACEUTICALS, INC.

CONSOLIDATED STATEMENTS OF CASH FLOWS

(in thousands)

Year ended December 31, 

2021

2020

CASH FLOWS FROM OPERATING ACTIVITIES:

Net loss

$

(93,063)

$

(51,777)

Adjustments to reconcile net loss to net cash used in operating activities:

     Depreciation expense

2

2

     Stock-based compensation

7,785

730

     Warrant expense

5,383

     Gain on extinguishment of debt

(121)

     Change in fair value of warrant liabilities

(1,692)

     Change in fair value of earnout cash liability

(20,938)

     Change in fair value of embedded put

27

     Amortization of debt discount

17

     Non-cash interest expense

19

65

     Non-cash settlement expense

21,366

39,486

     Non-cash consulting expense

53,837

     Loss on common stock issued to settle accounts payable

42

     Loss on conversion for notes payable

307

Changes in operating assets and liabilities:

     Accounts receivable

831

(831)

     Prepaid expenses and other assets

(4,809)

(143)

     Accounts payable

(19)

1,183

     Accrued expenses and other liabilities

(901)

3,244

        Net cash used in operating activities

(37,703)

(2,265)

CASH FLOWS FROM INVESTING ACTIVITIES

Purchase of computer equipment

(7)

(2)

        Net cash used in investing activities

(7)

(2)

CASH FLOWS FROM FINANCING ACTIVITIES

Proceeds from notes payable

620

Proceeds from issuance of series B-2 preferred stock

50

Proceeds from issuance of common stock and exercise of stock options, net of transaction costs

9,624

2,579

Proceeds from issuance of common stock for exercise of warrant

16,699

Proceeds from issuance of common stock and warrants issued in private placement, net of issuance costs

27,359

Effect of Merger, PIPE financing, net of transaction costs

11,050

Repayment of notes payable assumed in Merger

(1,100)

Repayment of notes payable - related party

(176)

        Net cash provided by financing activities

63,456

3,249

Net increase in cash

25,746

982

Cash at beginning of period

1,859

877

Cash at end of period

$

27,605

$

1,859

 

 

 

SOURCE NRx Pharmaceuticals, Inc.