Workflow
NRX Pharmaceuticals(NRXP)
icon
Search documents
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
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]
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 ...
NRX Pharmaceuticals(NRXP) - 2022 Q1 - Quarterly Report
2022-05-16 20:08
Table of Contents (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, 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) UNITED STATES SECURITIES AND EXCHANGE COMMISSION WASHINGTON, D.C. 20549 FORM 10-Q Delaware 82-2844431 (Sta ...
NRX Pharmaceuticals(NRXP) - 2022 Q1 - Earnings Call Transcript
2022-05-16 15:05
NRx Pharmaceuticals, Inc. (NASDAQ:NRXP) Q1 2022 Earnings Conference Call May 16, 2022 8:30 AM ET Company Participants Robert Besthof ??? Interim Chief Executive Officer, Head of Operations & Chief Commercial Officer Tom Johnson ??? Investor Relations Ira Strassberg ??? Chief Financial Officer and Treasurer Conference Call Participants Operator Greetings and welcome to NRX Pharmaceuticals First Quarter 2022, Earnings Conference Call. At this time, all participants are in listen-only mode. [Operator Instructi ...
NRX Pharmaceuticals(NRXP) - 2021 Q4 - Earnings Call Transcript
2022-03-31 21:19
NRx Pharmaceuticals, Inc. (NASDAQ:NRXP) Q4 2021 Earnings Conference Call March 31, 2022 8:30 AM ET Company Participants Eric Goldstein - MD, LifeSci Advisors, IR Robert Besthof - Interim CEO, Head of Operations & Chief Commercial Officer Ira Strassberg - CFO and Treasurer Conference Call Participants Operator Greetings and welcome to the NRx Pharmaceuticals Full Year 2021 Earnings Call. At this time all participants are in a listen-only mode. A question-and-answer session will follow the formal presentation ...