NRX-101 is first oral antidepressant to show 33% advantage in sustained remission in suicidality (not statistically significant at this sample size) and 75% advantage in relief from Akathisia relative to lurasidone - never previously shown with an oral antidepressant. Suicidality signal met the study's promising zone criteria and the akathisia signal approached statistical significance (P=0.076)  Both NRX-101 and lurasidone, an accepted standard of care in Bipolar Depression, demonstrated approximately 50% ...

The most recent trading session ended with NRx Pharmaceuticals, Inc. (NRXP) standing at $3.14, reflecting a +0.64% shift from the previouse trading day's closing. The stock outpaced the S&P 500's daily loss of 0.46%. On the other hand, the Dow registered a loss of 0.98%, and the technology-centric Nasdaq decreased by 0.64%.Shares of the company have depreciated by 41.13% over the course of the past month, underperforming the Medical sector's loss of 4.9% and the S&P 500's loss of 3.04%.Investors will be eag ...

Financial Performance - NRx Pharmaceuticals achieved a net loss of $30.2 million for the fiscal year 2023, an improvement from a net loss of $39.8 million in 2022, resulting in an accumulated deficit of $253.1 million as of December 31, 2023[525]. - NRx Pharmaceuticals reported a net loss of $30.15 million for the year ended December 31, 2023, a decrease of $9.6 million compared to a net loss of $39.75 million in 2022[536]. - NRx Pharmaceuticals improved its negative Earnings per Share to ($0.40) in FY 2023, compared to ($0.60) in the prior 12-month period, with management projecting positive cash flow by year-end 2024[512]. - The Company reported a net cash used in operating activities of $21.657 million for the year ended December 31, 2023, compared to $39.755 million in 2022[572]. - Total operating expenses for 2023 were $27.84 million, down from $44.34 million in 2022, reflecting a reduction of $16.5 million[536]. - Research and development expenses decreased to $13.37 million in 2023 from $17.03 million in 2022, primarily due to a $2.1 million reduction in clinical trial costs[537]. - General and administrative expenses fell to $14.22 million in 2023, down from $27.31 million in 2022, a decrease of $13.1 million[538]. - The company has not generated any revenues and continues to incur significant operating losses, relying on equity and debt financing for operations[545]. - The Company has a convertible note payable of $9.161 million as of December 31, 2023, down from $10.525 million in 2022[571]. - Total liabilities increased to $19.048 million in 2023 from $18.407 million in 2022[571]. Capital Raising and Financing Activities - The company successfully raised $9.2 million in new capital during FY 2023, with an additional $7.8 million added to working capital in Q1 2024, contributing to a greater than 50% reduction in corporate indebtedness[512]. - The Company completed a public offering in February 2024, raising approximately $1.5 million at a price of $0.30 per share[546]. - A private placement in February 2024 generated approximately $1.0 million from the sale of 2.7 million shares at a price of $0.38 per share[549]. - Financing activities provided $6.201 million of cash in 2023, primarily from the issuance of common stock and Series A preferred stock[576]. - For the year ended December 31, 2022, financing activities provided $32.2 million in cash, including $22.7 million from the issuance of common stock and warrants, and $10.0 million from convertible notes payable[577]. - The Company issued 3,866,666 shares of common stock in March 2023, raising approximately $2.5 million[560]. - The Company issued 9,670,002 shares of common stock in June 2023, generating approximately $5.6 million in net cash proceeds[566]. Drug Development and Partnerships - NRx Pharmaceuticals established a drug development partnership with Alvogen, Inc. and Lotus Pharmaceutical Company, which could yield up to $330 million in milestone payments and a double-digit royalty on net sales worldwide[512]. - NRx-101 received Breakthrough Therapy Designation from the FDA, demonstrating a significant reduction in symptoms of depression and suicidality in bipolar patients[518]. - The company has manufactured over 1 million oral doses of NRX-101 to commercial standards, with expectations of five years of room temperature shelf stability[513]. - NRx Pharmaceuticals has identified NRX-101 as a potent antibiotic for treating complicated urinary tract infections, receiving Qualified Infectious Disease Product and Fast Track designations from the FDA[517]. - The Company entered into a License Agreement with Alvogen, allowing for up to $330 million in cash milestone payments, including an initial $10 million[564]. - The Company is eligible to receive $5 million as an advance of the first milestone completion within the Alvogen Agreement as of February 7, 2024[565]. - The company completed patient data collection for a clinical trial studying suicidal bipolar depression, with top-line data expected in April 2024[512]. Compliance and Concerns - NRx Pharmaceuticals received a notice from Nasdaq for non-compliance with the minimum market value of listed securities, requiring a minimum of $50 million for 10 consecutive business days by January 22, 2024[529]. - NRx Pharmaceuticals has concluded that substantial doubt exists about its ability to continue as a going concern for at least twelve months from the issuance of its consolidated financial statements[526]. Accounting and Valuation - The company utilizes the Black-Scholes option-pricing model to estimate the fair value of stock option awards, considering factors such as volatility and expected term[585]. - The fair value of the convertible note payable is estimated using a Monte Carlo simulation model, which incorporates factors like equity volatility and risk-free interest rate[590]. - The company has no significant accounting policies that require subjective estimates and judgments that could materially impact its financial condition[582]. - The company’s convertible promissory note is accounted for at fair value, with changes recorded as non-operating loss in the consolidated statements of operations[589]. - The company has no cash dividends on common stock and does not expect to pay any in the foreseeable future[585]. - The company’s management evaluates estimates and judgments on an ongoing basis, with significant estimates related to earnout cash liability and stock-based compensation[581]. Royalties and Obligations - The company is obligated to pay ongoing royalties of 1% to 2.5% of NRX-101 gross sales to Sarah Herzog Memorial Hospital, along with milestone payments of $0.3 million upon completion of phase 3 trials[579]. - The Company has a Minimum Payment Period until December 31, 2023, with monthly payments of $400,000 to Streeterville[556]. - The milestone payments for developmental and commercial milestones range from $0.1 million to $0.8 million[579].

PART I - FINANCIAL INFORMATION [ITEM 1. Financial Statements](index=4&type=section&id=ITEM%201.%20Financial%20Statements) This section presents the unaudited condensed consolidated financial statements of NRx Pharmaceuticals, Inc. for the periods ended September 30, 2023, and December 31, 2022, including balance sheets, statements of operations and comprehensive loss, statements of changes in stockholders' (deficit) equity, and statements of cash flows, along with detailed notes explaining the company's organization, significant accounting policies, liquidity, debt, equity, and related party transactions [Condensed Consolidated Balance Sheets](index=4&type=section&id=Condensed%20Consolidated%20Balance%20Sheets) This section presents the company's financial position, detailing assets, liabilities, and equity at specific reporting dates | Metric (in thousands) | Sep 30, 2023 (Unaudited) | Dec 31, 2022 | | :-------------------- | :----------------------- | :----------- | | Cash and cash equivalents | $8,902 | $20,054 | | Total current assets | $13,089 | $25,795 | | Total assets | $13,110 | $25,816 | | Total current liabilities | $19,327 | $15,585 | | Total liabilities | $19,327 | $18,407 | | Total stockholders' (deficit) equity | $(6,217) | $7,409 | - The company's cash and cash equivalents decreased significantly from **$20.054 million** at December 31, 2022, to **$8.902 million** at September 30, 2023[9](index=9&type=chunk) - Total assets decreased by nearly 50% from **$25.816 million** to **$13.110 million**, while total liabilities increased from **$18.407 million** to **$19.327 million**[9](index=9&type=chunk) - Stockholders' equity shifted from a positive **$7.409 million** to a deficit of **$(6.217) million**[9](index=9&type=chunk) [Unaudited Condensed Consolidated Statements of Operations and Comprehensive Loss](index=5&type=section&id=Unaudited%20Condensed%20Consolidated%20Statements%20of%20Operations%20and%20Comprehensive%20Loss) This section details the company's financial performance, including revenues, expenses, and net loss over specific periods Consolidated Statements of Operations and Comprehensive Loss (in thousands) | Metric | Three months ended Sep 30, 2023 | Three months ended Sep 30, 2022 | Nine months ended Sep 30, 2023 | Nine months ended Sep 30, 2022 | | :----------------------------------- | :------------------------------ | :------------------------------ | :----------------------------- | :----------------------------- | | Research and development | $3,314 | $4,129 | $10,837 | $12,571 | | General and administrative | $2,494 | $5,012 | $12,344 | $21,876 | | Total operating expenses | $5,808 | $9,141 | $23,431 | $34,447 | | Loss from operations | $(5,808) | $(9,141) | $(23,431) | $(34,447) | | Net loss | $(6,062) | $(9,083) | $(25,818) | $(29,513) | | Basic and diluted net loss per share | $(0.07) | $(0.14) | $(0.35) | $(0.45) | - For the three months ended September 30, 2023, net loss decreased to **$(6.062) million** from **$(9.083) million** in the prior year, primarily due to a reduction in general and administrative expenses[13](index=13&type=chunk) - For the nine months ended September 30, 2023, net loss also decreased to **$(25.818) million** from **$(29.513) million** in the prior year, driven by lower operating expenses and a significant positive change in the fair value of earnout cash liability[13](index=13&type=chunk) [Unaudited Condensed Consolidated Statements of Changes in Stockholders' (Deficit) Equity](index=6&type=section&id=Unaudited%20Condensed%20Consolidated%20Statements%20of%20Changes%20in%20Stockholders'%20(Deficit)%20Equity) This section tracks changes in the company's equity, reflecting net losses, stock issuances, and other equity-related transactions Changes in Stockholders' (Deficit) Equity (in thousands) | Metric | Dec 31, 2022 | Mar 31, 2023 | Jun 30, 2023 | Sep 30, 2023 | | :----------------------------------- | :----------- | :----------- | :----------- | :----------- | | Total Stockholders' (Deficit) Equity | $7,409 | $(284) | $(2,808) | $(6,217) | | Common stock and warrants issued | — | $2,545 | $5,577 | $1,171 | | Stock-based compensation | — | $695 | $544 | $351 | | Net loss | — | $(11,039) | $(8,717) | $(6,062) | - The company's total stockholders' equity transitioned from a positive balance of **$7.409 million** at December 31, 2022, to a deficit of **$(6.217) million** by September 30, 2023[16](index=16&type=chunk) - This decline was primarily due to recurring net losses, partially offset by proceeds from common stock, warrants, and preferred stock issuances[16](index=16&type=chunk) [Unaudited Condensed Consolidated Statements of Cash Flows](index=8&type=section&id=Unaudited%20Condensed%20Consolidated%20Statements%20of%20Cash%20Flows) This section outlines the company's cash inflows and outflows from operating, investing, and financing activities over specific periods Consolidated Statements of Cash Flows (in thousands) | Cash Flow Activity | Nine months ended Sep 30, 2023 | Nine months ended Sep 30, 2022 | | :-------------------------------- | :----------------------------- | :----------------------------- | | Net cash used in operating activities | $(18,465) | $(31,437) | | Net cash used in investing activities | $(4) | $(11) | | Net cash provided by financing activities | $7,317 | $22,092 | | Net (decrease) increase in cash and cash equivalents | $(11,152) | $(9,356) | | Cash and cash equivalents at end of period | $8,902 | $18,249 | - Net cash used in operating activities decreased from **$(31.437) million** in the nine months ended September 30, 2022, to **$(18.465) million** in the same period of 2023[21](index=21&type=chunk) - However, net cash provided by financing activities also significantly decreased from **$22.092 million** to **$7.317 million**, leading to a larger net decrease in cash and cash equivalents in 2023[21](index=21&type=chunk) [Notes to Unaudited Condensed Consolidated Financial Statements](index=9&type=section&id=Notes%20to%20Unaudited%20Condensed%20Consolidated%20Financial%20Statements) This section provides detailed explanations and disclosures supporting the unaudited condensed consolidated financial statements [1. Organization](index=9&type=section&id=1.%20Organization) This section describes NRx Pharmaceuticals' core business, product development, licensing agreements, and funding strategies for new therapeutic targets - NRx Pharmaceuticals, Inc. is a clinical-stage pharmaceutical company focused on developing life-saving medicines through its subsidiary, NeuroRx[23](index=23&type=chunk)[24](index=24&type=chunk)[219](index=219&type=chunk) - The company's primary product, NRX-101 (D-cycloserine/Lurasidone), targets bipolar depression with suicidality and has received Fast Track and Breakthrough Therapy designations from the FDA[23](index=23&type=chunk)[24](index=24&type=chunk)[219](index=219&type=chunk) - **NRX-101 Development:** Expanded from suicidal bipolar depression to include Chronic Pain and Complicated Urinary Tract Infection (cUTI)[25](index=25&type=chunk)[26](index=26&type=chunk)[27](index=27&type=chunk) - The ongoing Phase 2b/3 trial for Treatment-Resistant Bipolar Depression (TRBD) is nearing enrollment completion, with results potentially usable for registrational filings[25](index=25&type=chunk)[26](index=26&type=chunk)[27](index=27&type=chunk) - **NRX-100 (Ketamine) Progress:** Collaborating with French and US institutions to gather data for a New Drug Application (NDA) for intravenous ketamine in acutely suicidal patients, targeting Q1 2024 submission and Q4 2024 PDUFA date[34](index=34&type=chunk)[35](index=35&type=chunk) - A development and manufacturing agreement with Nephron Pharmaceuticals aims to create a single-patient, diversion-resistant ketamine presentation[38](index=38&type=chunk)[39](index=39&type=chunk)[40](index=40&type=chunk)[41](index=41&type=chunk)[42](index=42&type=chunk)[43](index=43&type=chunk)[44](index=44&type=chunk) - **New Therapeutic Targets

Table of Contents UNITED STATES SECURITIES AND EXCHANGE COMMISSION WASHINGTON, D.C. 20549 FORM 10-Q (Mark One) ☒ QUARTERLY REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the Quarterly Period Ended: June 30, 2023 ☐ TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the transition period from to Commission File Number: 001-38302 NRX PHARMACEUTICALS, INC. (Exact name of registrant as specified in its charter) (State or other jurisdict ...

Table of Contents UNITED STATES SECURITIES AND EXCHANGE COMMISSION WASHINGTON, D.C. 20549 FORM 10-Q (Mark One) ☒ QUARTERLY REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the Quarterly Period Ended: March 31, 2023 ☐ TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the transition period from to Commission File Number: 001-38302 NRX PHARMACEUTICALS, INC. (Exact name of registrant as specified in its charter) Delaware 82-2844431 (Sta ...

Financial Performance - For the years ended December 31, 2022 and 2021, NRx Pharmaceuticals reported a net loss of $39.8 million and $93.1 million, respectively, with an accumulated deficit of $223.0 million as of December 31, 2022[460]. - The total operating expenses for the year ended December 31, 2022, were $44.3 million, a decrease of $71.5 million compared to $115.8 million in 2021[465]. - For the year ended December 31, 2022, NRx Pharmaceuticals recorded general and administrative expenses of $27.3 million, a decrease of $47.6 million from $74.9 million in 2021, primarily due to a reduction in consultant fees[467]. - NRx Pharmaceuticals recorded no settlement expense for the year ended December 31, 2022, compared to $21.4 million in 2021 related to the GEM Warrant[468]. - The company reported a net cash used in operating activities of $39.8 million for the year ended December 31, 2022, compared to $37.7 million in 2021[485]. - NRx Pharmaceuticals generated no revenues and expects to continue incurring significant operating losses for the foreseeable future, relying on equity and debt financing[475]. - As of December 31, 2022, NRx Pharmaceuticals had cash of $20.1 million and total liabilities of $18.4 million, resulting in total stockholders' equity of $7.4 million[484]. Research and Development - Research and development expenses for the year ended December 31, 2022, were $17.0 million, down from $20.3 million in 2021, primarily due to a decrease in clinical trial expenses[466]. - NRx Pharmaceuticals expects to report top-line data from its ongoing trial for NRX-101 in the first quarter of 2024[462]. - NRX-101 demonstrated over a 50% reduction in depression symptoms and a 75% reduction in suicidal ideation in bipolar patients receiving a combination treatment in clinical studies[452]. - NRx Pharmaceuticals plans to initiate a Phase 2 clinical trial of NRX-101 for PTSD in the second half of 2023, targeting pathways similar to those in other depression conditions[462]. - The U.S. population of patients with Suicidal Treatment Resistant Bipolar Depression is estimated to be between 700,000 and 1,000,000 individuals[462]. Regulatory and Manufacturing - The FDA has granted NRX-101 Breakthrough Therapy designation and a Special Protocol Agreement for the treatment of bipolar depression in patients with acute suicidal ideation and behavior, affecting approximately 150,000 to 180,000 patients annually in the U.S.[455]. - NRx Pharmaceuticals has transferred Phase 3 commercial drug manufacturing processes to the U.S. and submitted its manufacturing file to the FDA for NRX-101[455]. - The company has 47 issued patents and more than 43 pending patents related to the synergy between D-cycloserine and lurasidone in treating CNS disorders[453]. Financing Activities - The company issued a 9% redeemable promissory note for an aggregate principal amount of $11.0 million on November 4, 2022, with net proceeds of $10.0 million after transaction costs[476]. - Financing activities provided $32.2 million of cash in 2022, primarily from $22.7 million in proceeds from the issuance of common stock and warrants[489]. - The company completed a private placement on February 2, 2022, issuing 7,824,727 shares of common stock and Preferred Investment Options with an estimated fair value of $15.5 million[481][482]. Accounting and Valuation - NRx Pharmaceuticals has no off-balance sheet transactions or guarantees beyond normal business operations[493]. - NRx Pharmaceuticals' Earnout Cash Liability expired as of December 31, 2022, without achieving milestones due to halted trials, resulting in a relief of the liability[498]. - The fair value of common stock is determined based on the closing market price on the date of grant post-merger[499]. - Stock-based compensation is recognized over the requisite service period, with fair value estimated using the Black-Scholes option-pricing model[500][501]. - Warrant liabilities are assessed for equity or liability classification based on specific terms, with changes in fair value recognized as non-cash gains or losses[503][506]. - The convertible note payable is accounted for at fair value, with changes recorded as non-operating loss, using a Monte Carlo simulation model for estimation[507][508]. - The assumptions for fair value estimates involve inherent uncertainties, which could lead to materially different future expenses[502][509]. - NRx Pharmaceuticals evaluates its estimates and judgments on an ongoing basis, impacting reported amounts of assets and liabilities[494]. - The company’s critical accounting policies require subjective estimates that may materially impact its financial condition[495]. - The Earnout Cash liability was based on probability-weighted discounted cash flow models, incorporating significant inputs related to FDA approvals[498]. - The company has never paid cash dividends on common stock and does not expect to do so in the foreseeable future[501].

Financial Data and Key Metrics Changes - For the year ended December 31, 2022, the company recorded a net loss of $39.8 million, an improvement of $53.3 million compared to a net loss of $93.1 million for the previous year [67] - Research and development (R&D) expenses decreased to $17.0 million from $20.3 million in the prior year, primarily due to a reduction in clinical trial expenses related to discontinued projects [40] - General and administrative (G&A) expenses significantly decreased to $27.4 million from $74.9 million, mainly due to a reduction in consulting fees [87] Business Line Data and Key Metrics Changes - The company is focusing on the development of NRX-101, a drug for treating bipolar depression and PTSD, with promising Phase 2 data showing significant reductions in depression and suicidality compared to standard therapy [9][10] - The ongoing Phase 2b/3 trial of NRX-101 is expected to provide data by the end of the year, which may be used for future registrational filings [5][35] Market Data and Key Metrics Changes - The company aims to address the unmet medical needs of approximately 7 million individuals in the U.S. suffering from bipolar disorder, with a focus on those experiencing suicidality [18][58] - The FDA has suggested expanding the indication for NRX-101 to include chronic treatment of patients with bipolar depression and intermittent suicidality, potentially broadening the addressable market [58] Company Strategy and Development Direction - The company is committed to advancing its clinical trials for NRX-101 and has aligned with the FDA on a path to commercial-stage product development [46] - The Breakthrough Therapy Designation received for NRX-101 allows for expedited submission of a new drug application, with plans to submit by the end of the year [25][79] - The company is also exploring the potential of NRX-101 for treating PTSD, with a Phase 2 study anticipated to start in the second quarter of 2023 [37][62] Management's Comments on Operating Environment and Future Outlook - Management expressed optimism about the potential of NRX-101 to change the treatment paradigm for individuals with bipolar depression and suicidality, emphasizing the commitment to underserved patients [70] - The company anticipates a productive year in 2023, with multiple regulatory and clinical catalysts expected to drive progress [70] Other Important Information - The company appointed Matthew Duffy as Chief Business Officer, bringing experience from leading pharmaceutical companies [12] - The company has established a strong intellectual property position with 90 patents related to the treatment of bipolar depression and other CNS conditions [49][85] Q&A Session Summary Question: Can you explain the DSMB's lack of utility statement? - The DSMB indicated no futility signal was identified, suggesting that the active drug may show efficacy compared to the competitor, although not yet statistically significant [72][73] Question: What modifications might occur in the Phase 3 trial? - The company is considering combining trials and focusing on maintaining the effects of ketamine, while also exploring NRX-101's efficacy without prior ketamine use [76][77] Question: What is the significance of the Breakthrough Therapy Designation? - This designation allows for a rolling submission of the new drug application, facilitating a more efficient review process [78][79] Question: What are the expectations for patient enrollment and data analysis? - Patient enrollment and data analysis are critical, with a target safety database of 1,500 patients as suggested by the FDA [108] Question: Will there be changes in patient screening for the Phase 2b/3 study? - The company is focused on ensuring accurate psychometric ratings and maintaining control over study site performance to improve statistical significance [115][141]

Table of Contents UNITED STATES SECURITIES AND EXCHANGE COMMISSION WASHINGTON, D.C. 20549 FORM 10-Q (Mark One) ☒ QUARTERLY REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the Quarterly Period Ended: September 30, 2022 Commission File Number: 001-38302 NRX PHARMACEUTICALS, INC. (Exact name of registrant as specified in its charter) Delaware 82-2844431 (State or other jurisdiction of (I.R.S. Employer incorporation or organization) 1201 Orange Street, Suite 600 Wilmington, DE ...

NRx Pharmaceuticals, Inc. (NASDAQ:NRXP) Q3 2022 Earnings Conference Call November 14, 2022 8:00 AM ET Company Participants Suzanne Messere - Investor Relations Stephen Willard - Chief Executive Officer Seth Van Voorhees - Chief Financial Officer and Treasurer Jonathan Javitt - Founder and Chief Scientist Conference Call Participants Vernon Bernadino - H.C. Wainwright Ed Woo - Ascendiant Capital Operator Good morning, and welcome to the NRx Pharmaceuticals Third Quarter 2022 Earnings Conference Call. All par ...