NRX Pharmaceuticals(NRXP)

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NRx Pharmaceuticals, Inc. (NASDAQ:NRXP) to Participate in the EF Hutton Annual Global Conference on May 15, 2024
Prnewswire· 2024-05-08 12:30
RADNOR, Pa., May 8, 2024 /PRNewswire/ -- NRx Pharmaceuticals, Inc. (Nasdaq: NRXP) ("NRx Pharmaceuticals", the "Company"), a clinical-stage biopharmaceutical company, today announced that it will participate in the EF Hutton Annual Global Conference, which will take place on May 15, 2024, at The Plaza Hotel in New York City. Prof. Jonathan Javitt, MD, MPH, the Company's Chairman and Chief Scientist, and Matthew Duffy, the Company's Chief Business Officer, will hold one-on-one meetings with investors througho ...
NRx Pharmaceuticals, Inc. (Nasdaq:NRXP) to Report First Quarter 2024 Financial Results on May 14, 2024
Prnewswire· 2024-05-07 20:01
RADNOR, Pa., May 7, 2024 /PRNewswire/ -- NRx Pharmaceuticals, Inc. (Nasdaq: NRXP) ("NRx Pharmaceuticals", the "Company"), a clinical-stage biopharmaceutical company, today announced that it will release its first quarter 2024 financial results after the market closes on Tuesday, May 14, 2024, via press release, which will be available on the Company's website at https://ir.nrxpharma.com/. The Company will host a conference call to discuss the financial results as well as provide a corporate update at 4:30pm ...
NRx Pharmaceuticals (Nasdaq:NRXP) Announces Final Clinical Trial Results: Superior Safety Combined with Similar Efficacy in the Trial of NRX-101 Compared to Lurasidone in Suicidal Bipolar Depression
Prnewswire· 2024-05-06 12:30
Both drugs demonstrated > 50% response for treating depression. NRX-101 demonstrated a mean 76% reduction in symptoms of akathisia compared to lurasidone that was sustained over 42 days (Effect Size .37; P=0.025), using prespecified analytic methodology memorialized in FDA Special Protocol Agreement. Levels of akathisia with NRX-101 were essentially zero at day 42 This safety advantage was previously reported in the Company's published STABIL-B trial Akathisia is identified as a life-threatening side effec ...
NRx Pharmaceuticals (Nasdaq:NRXP) Announces Promising Findings in Phase 2b/3 Clinical Trial of NRX-101 vs. Lurasidone for Treatment of Suicidal Bipolar Depression
Prnewswire· 2024-04-30 12:30
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% ...
NRx Pharmaceuticals, Inc. (NRXP) Advances While Market Declines: Some Information for Investors
Zacks Investment Research· 2024-04-25 23:01
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 ...
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].