Full Press Release Details
Reports Full Year 2022 Financial Results and Provides Business Update
30, 2022 - NRx Pharmaceuticals, Inc. (Nasdaq: NRXP) ("NRx Pharmaceuticals", the "Company"), a clinical-stage
biopharmaceutical company, today announced its financial results for the full year 2022 and provided a business and clinical update.
exciting year of continued execution for NRx Pharmaceuticals as we reinitiated our psychiatry drug development program post-pandemic and
advanced clinical development for our lead investigational compound, NRX-101, in Suicidal Treatment-Resistant Bipolar Depression,"
said Stephen Willard, J.D., Chief Executive Officer and Director of NRx Pharmaceuticals. "We are delighted to augment our advisory
board with two world-class leaders in psychiatry, Professors Andrew Nierenberg of Harvard Medical School, and Marion Leboyer of INSERM,
one of France's leading universities. Prof. Nierenberg also serves as Principal Investigator of our ongoing Clinical Trials. The
first few months of 2023 have been particularly productive. We initiated a Phase 3 registrational clinical trial for NRX-101 in patients
suffering from severe bipolar depression with acute suicidality and received an encouraging DSMB readout for a second trial in the far
broader indication of Suicidal Treatment-Resistant Bipolar Depression. We are following guidance from FDA to broaden the indication for
our medicine to the large population of patients treated in the outpatient setting who do not require acute stabilization with ketamine.
Of note, with this guidance, we believe the design of this study has effectively converged with our ongoing Phase 2b/3 outpatient trial.
This is the first time, to our knowledge, that patients with suicidal ideation have been welcomed in a clinical trial of an oral antidepressant.
Currently, the only approved treatment for patients with suicidality in depression is electroshock therapy, with its known complications.
time to be a part of NRx Pharmaceuticals as we look ahead to multiple near-term catalysts on track for 2023 and 2024. Based on our newly-completed
US-based manufacture of phase 3 scale medication using the expected commercial process, we have upgraded our outpatient trial to a phase
2b/3 study that may be used for registrational purposes, should it demonstrate safety and efficacy. We look forward to topline clinical
data from this trial by the first quarter of 2024. We are also initiating an Expanded Access Program for NRX-101 to serve patients who
have exhausted approved medicines for bipolar depression and to build the safety database requested by the FDA as part of the enlarged
outpatient indication they recommended in our recent Type B meeting. As we continue to progress our portfolio of potentially life-saving
therapeutics in a turbulent macroeconomic market, we are well-positioned following our registered direct offering to continue to advance
our mission of meeting the needs of underserved patients with serious CNS disorders."
dose combination of D-cycloserine, an NMDA antagonist, and lurasidone, a 5HT2a atypical antipsychotic and antidepressant, under investigation
for the treatment of Suicidal Treatment-Resistant Bipolar Depression .
and Recent Clinical and Regulatory Highlights
Indication - Acute Suicidal Ideation and Behavior (ASIB)
- Suicidal Treatment-Resistant Bipolar Depression (formerly Sub-acute Suicidal Ideation and Behavior (SSIB)
Consolidated NRX-101
Program in Suicidal Treatment-Resistant Bipolar Depression
NRX-101 Indication -
Post Traumatic Stress Disorder (PTSD)
Results for Twelve Months ended December 31, 2022
Call and Webcast Details
live webcast of the conference call will be available on the Company's website at https://ir.nrxpharma.com/news-events/ir-calendar.
An archive of the webcast will be available on the Company's website for 30 days. Participants that are unable to join the
webcast can access the conference call via telephone by dialing domestically +1 (833) 630-1956 or internationally +1 (412) 317-1837.
Up to 50% of individuals
with bipolar disorder attempt suicide over their lifetime, and estimates indicate that up to 20% may succumb to suicide. The only FDA-approved
treatment for patients with bipolar depression and acute suicidal ideation & behavior (ASIB) remains electroconvulsive therapy (ECT).
antidepressants can increase the risk of suicide in certain patients; hence their labels contain a warning to that effect. NRX-101
is a patented, oral, fixed dose combination of D-cycloserine and lurasidone, neither of which has shown addiction potential in
preclinical models. Based on the results of a Phase 2 proof-of-concept study, NRX-101 received Breakthrough Therapy Designation from
the FDA for the treatment of severe bipolar depression in patients with ASIB after initial stabilization with ketamine or other
the first oral antidepressants currently in late-stage clinical studies targeting the NMDA-receptor in the brain, which represents potentially
a key new mechanism to treat depression with and without suicidality, as well as PTSD and other indications. To date, NRX-101 is the only
oral NMDA investigational medicine focused on bipolar depression in patients with acute and sub-acute suicidality.
Clinical-stage biopharmaceutical
company developing therapeutics for the treatment of central nervous system disorders, specifically suicidal depression and post-traumatic
stress disorder (PTSD). The company's lead program NRX-101, an oral, fixed-dose combination of D-cycloserine and lurasidone, targets
the brain's NMDA receptor and is being investigated in a Phase 3 trial under an FDA Special Protocol Agreement and Breakthrough
Therapy Designation in patients with bipolar depression and suicidal ideation, an indication for which the only approved treatment is
electroshock therapy. NRx Pharmaceuticals has also initiated a Phase 2b clinical trial in patients with Sub-Acute Suicidality, a substantially
broader indication. The Breakthrough Therapy Designation and Special Protocol Agreement were awarded by the FDA based on the Company's
prior STABIL-B trial that demonstrated substantial improvement over available therapy in reducing depression and suicidality compared
to placebo when patients were treated with NRX-101 after a single dose of ketamine.
Regarding Forward-Looking Statements
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.
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.
Chief Business Officer
NRX PHARMACEUTICALS, INC.
CONSOLIDATED BALANCE SHEETS
(in thousands, except share and per share data)
| December 31, | ||||||||
| 2022 | 2021 | |||||||
| ASSETS | ||||||||
| Current assets: | ||||||||
| Cash and cash equivalents | $ | 20,054 | $ | 27,605 | ||||
| Prepaid expenses and other current assets | 5,741 | 5,109 | ||||||
| Total current assets | 25,795 | 32,714 | ||||||
| Other assets | 21 | 15 | ||||||
| Total assets | $ | 25,816 | $ | 32,729 | ||||
| LIABILITIES AND STOCKHOLDERS' EQUITY | ||||||||
| Current liabilities: | ||||||||
| Accounts payable | $ | 2,076 | $ | 3,687 | ||||
| Accrued and other current liabilities | 4,855 | 2,375 | ||||||
| Accrued clinical site costs | 914 | 469 | ||||||
| Earnout Cash liability | - | 4,582 | ||||||
| Convertible note payable and accrued interest - short term | 8,703 | - | ||||||
| Warrant liabilities | 37 | 292 | ||||||
| Note payable and accrued interest | - | 518 | ||||||
| Total current liabilities | 16,585 | 11,923 | ||||||
| Convertible note payable and accrued interest - long term | 1,822 | - | ||||||
| Total liabilities | $ | 18,407 | $ | 11,923 | ||||
| Preferred stock, $0.001 par value, 50,000,000 shares authorized; 0 shares issued and outstanding at December 31, 2022 and December 31, 2021, respectively | - | - | ||||||
| Common stock, $0.001 par value, 500,000,000 shares authorized; 66,442,989 and 58,810,550 shares issued and outstanding at December 31, 2022 and 2021, respectively | 67 | 59 | ||||||
| Additional paid-in capital | 230,401 | 203,990 | ||||||
| Accumulated deficit | (223,059 | ) | (183,243 | ) | ||||
| Total stockholders' equity | 7,409 | 20,806 | ||||||
| Total liabilities and stockholders' equity | $ | 25,816 | $ | 32,729 |
| NRX PHARMACEUTICALS, INC. | |
| CONSOLIDATED STATEMENTS OF OPERATIONS | |
| (in thousands, except share and per share data) |
| Year ended | ||||||||
| December 31, | ||||||||
| 2022 | 2021 | |||||||
| Operating expenses: | ||||||||
| Research and development | $ | 17,027 | $ | 20,257 | ||||
| General and administrative | 27,370 | 74,944 | ||||||
| Settlement expense | - | 21,366 | ||||||
| Reimbursement of expenses from Relief Therapeutics | - | (771 | ) | |||||
| Total operating expenses | 44,397 | 115,796 | ||||||
| Loss from operations | (44,397 | ) | (115,796 | ) | ||||
| Other (income) expenses: | ||||||||
| Gain on extinguishment of debt | - | (121 | ) | |||||
| Interest income | (249 | ) | - | |||||
| Interest expense | - | 18 | ||||||
| Change in fair value of convertible note payable | 505 | - | ||||||
| Change in fair value of warrant liabilities | (255 | ) | (1,692 | ) | ||||
| Change in fair value of Earnout Cash liability | (4,582 | ) | (20,938 | ) | ||||
| Total other (income) expenses | (4,581 | ) | (22,733 | ) | ||||
| Loss before tax | (39,816 | ) | (93,063 | ) | ||||
| Provision for income taxes | - | - | ||||||
| Net loss | (39,816 | ) | (93,063 | ) | ||||
| Deemed dividend | - | (255,822 | ) | |||||
| Net loss attributable to common stockholders | $ | (39,816 | ) | $ | (348,885 | ) | ||
| Net loss per share: | ||||||||
| Basic | $ | (0.61 | ) | $ | (1.98 | ) | ||
| Diluted | $ | (0.61 | ) | $ | (1.98 | ) | ||
| Net loss per share attributable to common stockholders: | ||||||||
| Basic | $ | (0.61 | ) | $ | (7.44 | ) | ||
| Diluted | $ | (0.61 | ) | $ | (7.44 | ) | ||
| Weighted average common shares outstanding: | ||||||||
| Basic and diluted | 65,766,786 | 46,917,701 |