NRX Pharmaceuticals(NRXP)

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NRX Pharmaceuticals(NRXP) - 2023 Q4 - Annual Report
2024-03-29 21:18
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].
NRX Pharmaceuticals(NRXP) - 2023 Q3 - Quarterly Report
2023-11-14 21:01
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, 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 ...
NRX Pharmaceuticals(NRXP) - 2023 Q2 - Quarterly Report
2023-08-14 20:34
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 ...
NRX Pharmaceuticals(NRXP) - 2023 Q1 - Quarterly Report
2023-05-15 21:04
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 ...
NRX Pharmaceuticals(NRXP) - 2022 Q4 - Annual Report
2023-03-31 20:13
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].
NRX Pharmaceuticals(NRXP) - 2022 Q4 - Earnings Call Transcript
2023-03-31 02:10
NRx Pharmaceuticals, Inc. (NASDAQ:NRXP) Q4 2022 Earnings Conference Call March 30, 2023 4:30 PM ET Company Participants Suzanne Messere - IR Stephen Willard - CEO Seth Van Voorhees - CFO Jonathan Javitt - Chief Scientist Conference Call Participants Jason Kolbert - Dawson James Vernon Bernadino - H.C. Wainwright Ed Woo - Ascendiant Capital Operator Good afternoon and welcome to the NRx Pharmaceuticals Full Year 2022 Results Conference Call. All participants will be in a listen-only mode. [Operator Instructi ...
NRX Pharmaceuticals(NRXP) - 2022 Q3 - Quarterly Report
2022-11-14 21:21
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(NRXP) - 2022 Q3 - Earnings Call Transcript
2022-11-14 14:52
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 ...
NRX Pharmaceuticals(NRXP) - 2022 Q2 - Quarterly Report
2022-08-15 21:56
Table of Contents UNITED STATES SECURITIES AND EXCHANGE COMMISSION WASHINGTON, D.C. 20549 FORM 10-Q For the Quarterly Period Ended: June 30, 2022 ☐ 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 (State or other jurisdiction of (I.R.S. Employer incorporation or organization) (Mark One) Identification ...
NRX Pharmaceuticals(NRXP) - 2022 Q2 - Earnings Call Transcript
2022-08-15 16:51
NRx Pharmaceuticals, Inc. (NASDAQ:NRXP) Q2 2022 Earnings Conference Call August 15, 2022 8:30 AM ET Company Participants Tom Johnson - Investor Relations Stephen Willard - Chief Executive Officer Seth Van Voorhees - Chief Financial Officer & Treasurer Robert Besthof - Head of Operations & Chief Commercial Officer Conference Call Participants Vernon Bernardino - HC Wainwright Operator Good day, and welcome to the NRx Pharmaceuticals Second Quarter 2022 Conference Call. All participants will be in a listen-on ...