Petition for a temporary restraining order brought by Streeterville Capital, LLC seeking injunctive relief to prevent spinoff of 49% of HOPE Therapeutics shares to current NRx Shareholders has been denied by Utah arbitrator. Petition by Streeterville Capital, LLC seeking injunctive relief to prevent sales of NRx shares has been denied by Utah arbitrator. NRx to proceed with spinoff of HOPE Therapeutics as previously announced. RADNOR, Pa., July 29, 2024 /PRNewswire/ -- NRx Pharmaceuticals, Inc. (Nasdaq: NRX ...

HOPE Therapeutics, Inc. (PRNewsfoto/NRx Pharmaceuticals, Inc.)HOPE Therapeutics, Inc. (PRNewsfoto/NRx Pharmaceuticals, Inc.) NRx continues work to enable the distribution of shares in Hope Therapeutics. This distribution is dependent upon completion of a public audit and successful review of an SEC Form 10. NRX-101 is the Company's patented (Composition of Matter), oral combination of the NMDA antagonist Dcycloserine and lurasidone for bipolar depression. Data from two active control clinical trials vs. the ...

NRx has recently announced plans to submit a New Drug Application for HTX-100 (IV ketamine), through Hope Therapeutics, in the treatment of suicidal depression, based on results of well-controlled clinical trials conducted under the auspices of the US National Institutes of Health and newly obtained data from French health authorities, licensed under a data sharing agreement. NRx was awarded Fast Track Designation for development of ketamine (NRX-100) by the US FDA as part of a protocol to treat patients wi ...

"I am delighted to welcome Dennis to the Board of NRx. His unique background in both Neuroscience and Medical Technology will be an important asset to the company as we seek to develop more advanced treatments for patients," said Dr. Jonathan Javitt, Chairman and Chief Scientist of NRx. "I have worked with Dennis previously on a highly successful digital therapeutic and know the quality he brings to our company." NRx Pharmaceuticals is a clinical-stage biopharmaceutical company developing therapeutics based ...

RADNOR, Pa., June 10, 2024 /PRNewswire/ -- NRx Pharmaceuticals, Inc. (Nasdaq: NRXP) ("NRx Pharmaceuticals", the "Company"), a clinical-stage biopharmaceutical company, today announced that the Company posted a new Shareholder Update Letter on its website NRx Shareholder Update and further invites interested parties to subscribe to their email alert service to stay up to date on company's progress here: NRx Email Alerts . (Note: not all updates will be included in a Press Release in the future). Today's upda ...

Financial Performance - NRx Pharmaceuticals reported a net loss reduction from $11.0 million in Q1 2023 to $6.5 million in Q1 2024, representing a 41% improvement year over year[17]. - Research and Development expenses decreased from $3.7 million in Q1 2023 to $1.7 million in Q1 2024, primarily due to a $1.6 million reduction in clinical trial expenses[17]. - NRx Pharmaceuticals has improved access to working capital by $8 million in total, including $2.9 million from equity sales and $5.1 million from Alvogen milestone advance[19]. Drug Development and Regulatory Approvals - The company plans to file a New Drug Application (NDA) for NRX-101 in the treatment of bipolar depression patients at risk of akathisia, based on positive Phase 2b/3 trial data[1][4]. - NRX-101 has been granted Qualified Infectious Disease Product (QIDP) designation, Fast Track, and Priority Review by the FDA for the treatment of complicated urinary tract infections (cUTI)[13]. - NRx has developed a patentable pH neutral formulation for ketamine, suitable for both intravenous and subcutaneous administration, with an NDA filing planned by July 2024[11]. - The company has initiated a 200-person DOD-funded trial of D-cycloserine (DCS) for chronic pain, with data expected shortly[1]. Market Potential and Partnerships - The company anticipates that if NRX-101 captures 10% of the cUTI market, it could generate hundreds of millions in annual revenue based on 3 million cases per year in the US[16]. - NRx Pharmaceuticals has partnered with Alvogen and Lotus Pharmaceuticals, receiving $5 million in milestone payments and potential future milestones of $329 million[5]. - The company plans to spin out HOPE Therapeutics, which focuses on care delivery and has received term sheets for $60 million in new investment[1]. Risk Factors and Forward-Looking Statements - The company emphasizes that forward-looking statements involve known and unknown risks, which may cause actual results to differ materially from anticipated outcomes[26]. - Investors are encouraged to review the company's most recent Annual Report on Form 10-K for detailed information on risk factors[26]. - The company does not assume any obligation to publicly update or revise forward-looking statements unless required by law[26].

PART I - FINANCIAL INFORMATION [ITEM 1. Financial Statements](index=3&type=section&id=ITEM%201.%20Financial%20Statements) NRx Pharmaceuticals' unaudited condensed consolidated financial statements and detailed accounting notes are presented [Condensed Consolidated Balance Sheets](index=3&type=section&id=Condensed%20Consolidated%20Balance%20Sheets) | Metric | March 31, 2024 (Unaudited) (in thousands) | December 31, 2023 (in thousands) | | :-------------------------------- | :--------------------------------------- | :------------------------------- | | Cash and cash equivalents | $1,319 | $4,595 | | Total current assets | $3,347 | $6,884 | | Total assets | $3,788 | $7,315 | | Total liabilities | $18,857 | $19,048 | | Total stockholders' deficit | $(15,069) | $(11,733) | - The company's cash and cash equivalents decreased significantly from **$4.595 million** at December 31, 2023, to **$1.319 million** at March 31, 2024, indicating a substantial reduction in liquidity[9](index=9&type=chunk) - Total stockholders' deficit worsened from **$(11.733) million** to **$(15.069) million**, reflecting continued net losses[9](index=9&type=chunk) [Unaudited Condensed Consolidated Statements of Operations and Comprehensive Loss](index=4&type=section&id=Unaudited%20Condensed%20Consolidated%20Statements%20of%20Operations%20and%20Comprehensive%20Loss) | Metric | Three months ended March 31, 2024 (in thousands) | Three months ended March 31, 2023 (in thousands) | Change (YoY) (in thousands) | | :------------------------------------ | :----------------------------------------------- | :----------------------------------------------- | :-------------------------- | | Research and development | $1,748 | $3,650 | $(1,902) | | General and administrative | $4,250 | $5,785 | $(1,535) | | Total operating expenses | $5,998 | $9,435 | $(3,437) | | Loss from operations | $(5,998) | $(9,435) | $3,437 | | Net loss | $(6,528) | $(11,039) | $4,511 | | Basic and diluted net loss per share | $(0.74) | $(1.66) | $0.92 | - Net loss decreased by **$4.511 million**, from **$(11.039) million** in Q1 2023 to **$(6.528) million** in Q1 2024, primarily due to reduced operating expenses and a smaller loss from the change in fair value of convertible note payable[12](index=12&type=chunk) - Research and development expenses decreased by **$1.902 million** (**52.1%**) year-over-year, and general and administrative expenses decreased by **$1.535 million** (**26.5%**) year-over-year[12](index=12&type=chunk) [Unaudited Condensed Consolidated Statements of Changes in Stockholders' Deficit](index=5&type=section&id=Unaudited%20Condensed%20Consolidated%20Statements%20of%20Changes%20in%20Stockholders'%20Deficit) | Metric | Balance December 31, 2023 (in thousands) | Balance March 31, 2024 (in thousands) | | :------------------------------------------------ | :--------------------------------------- | :------------------------------------ | | Total Stockholders' Deficit | $(11,733) | $(15,069) | | Stock-based compensation | — | $242 | | Conversion of Series A preferred stock | $3 | — | | ATM offering, net | — | $179 | | Common stock and warrants issued, net | — | $1,344 | | Common stock and warrants issued in private placement | — | $1,027 | | Shares issued as repayment of convertible note | — | $400 | | Net loss | $(253,147) | $(6,528) | - The total stockholders' deficit increased from **$(11.733) million** at December 31, 2023, to **$(15.069) million** at March 31, 2024, primarily due to the net loss incurred during the quarter, partially offset by capital raises[15](index=15&type=chunk) - The company issued common stock and warrants through ATM offerings and private placements, generating approximately **$2.545 million** in additional paid-in capital during the quarter[15](index=15&type=chunk) [Unaudited Condensed Consolidated Statements of Cash Flows](index=6&type=section&id=Unaudited%20Condensed%20Consolidated%20Statements%20of%20Cash%20Flows) | Metric | Three months ended March 31, 2024 (in thousands) | Three months ended March 31, 2023 (in thousands) | | :------------------------------------ | :----------------------------------------------- | :----------------------------------------------- | | Net cash used in operating activities | $(3,671) | $(6,089) | | Net cash used in investing activities | $0 | $(4) | | Net cash provided by financing activities | $395 | $2,545 | | Net decrease in cash and cash equivalents | $(3,276) | $(3,548) | | Cash and cash equivalents at end of period | $1,319 | $16,506 | - Net cash used in operating activities decreased from **$6.089 million** in Q1 2023 to **$3.671 million** in Q1 2024, reflecting reduced net loss and changes in operating assets and liabilities[17](index=17&type=chunk) - Net cash provided by financing activities significantly decreased from **$2.545 million** in Q1 2023 to **$0.395 million** in Q1 2024, primarily due to higher convertible note repayments in 2024[17](index=17&type=chunk) - Cash and cash equivalents at the end of the period decreased to **$1.319 million** from **$4.595 million** at the beginning of the period, indicating continued cash burn[17](index=17&type=chunk) [Notes to Unaudited Condensed Consolidated Financial Statements](index=7&type=section&id=Notes%20to%20Unaudited%20Condensed%20Consolidated%20Financial%20Statements) [1. Organization](index=7&type=section&id=1.%20Organization) - NRx Pharmaceuticals, Inc. is a clinical-stage biopharmaceutical company focused on novel therapeutics for central nervous system disorders, including suicidal depression, chronic pain, PTSD, and schizophrenia[19](index=19&type=chunk) - The company operates through two subsidiaries: NeuroRx, Inc. (R&D) and HOPE Therapeutics, Inc. (specialty pharmaceutical for ketamine distribution)[19](index=19&type=chunk) - Drug development activities are centered on the NMDA receptor, with expanded indications for NRX-101 (suicidal bipolar depression, chronic pain, PTSD) and intravenous ketamine (NRX-100/HTX-100) for suicidal depression[20](index=20&type=chunk) - A Memorandum of Understanding was signed with Fondation FundaMental to co-develop an NMDA-targeted treatment for schizophrenia[20](index=20&type=chunk) [2. Going Concern](index=7&type=section&id=2.%20Going%20Concern) - As of March 31, 2024, the Company had **$1.3 million** in cash and cash equivalents and a working capital deficit, with no revenues and expected continued operating losses[21](index=21&type=chunk) - The Company's ability to continue operations is dependent on raising additional equity and/or debt financing, which may not be available on favorable terms or at all[22](index=22&type=chunk) - Management concluded that substantial doubt exists about the Company's ability to continue as a going concern for at least twelve months from the financial statement issuance date[22](index=22&type=chunk) [3. Summary of Significant Accounting Policies](index=9&type=section&id=3.%20Summary%20of%20Significant%20Accounting%20Policies) - On April 1, 2024, the Company effected a **1-for-10** reverse stock split, retroactively adjusting all historical share amounts (except Series A Preferred Stock)[26](index=26&type=chunk) - Key estimates in financial statements relate to the fair value of convertible note payable, stock options, warrants, and utilization of deferred tax assets[28](index=28&type=chunk) - Revenue recognition follows ASC 606, with a five-step model for contracts with customers, evaluating performance obligations, transaction price, and timing of revenue recognition[38](index=38&type=chunk)[44](index=44&type=chunk) - The convertible note payable is accounted for at fair value, with subsequent changes recorded in non-operating loss, and changes due to credit risk in comprehensive income[52](index=52&type=chunk) - Warrants are classified as equity or liability based on specific terms and accounting guidance, with liability-classified warrants remeasured at fair value each period[56](index=56&type=chunk)[57](index=57&type=chunk) [4. Prepaid Expense and Other Current Assets](index=20&type=section&id=4.%20Prepaid%20Expense%20and%20Other%20Current%20Assets) | Category | March 31, 2024 (in thousands) | December 31, 2023 (in thousands) | | :------------------------------ | :---------------------------- | :----------------------------- | | Prepaid clinical development costs | $823 | $871 | | Prepaid insurance | $638 | $1,078 | | Other prepaid expense | $433 | $334 | | Other current assets | $128 | $0 | | Other current receivables | $6 | $6 | | **Total** | **$2,028** | **$2,289** | - Total prepaid expense and other current assets decreased from **$2.289 million** at December 31, 2023, to **$2.028 million** at March 31, 2024[68](index=68&type=chunk) [5. Accrued and Other Current Liabilities](index=20&type=section&id=5.%20Accrued%20and%20Other%20Current%20Liabilities) | Category | March 31, 2024 (in thousands) | December 31, 2023 (in thousands) | | :------------------------------ | :---------------------------- | :----------------------------- | | Professional services | $2,766 | $2,686 | | Accrued research and development expense | $992 | $1,112 | | Accrued employee costs | $959 | $835 | | Other accrued expense | $579 | $81 | | **Total** | **$5,296** | **$4,714** | - Total accrued and other current liabilities increased by **$0.582 million**, from **$4.714 million** at December 31, 2023, to **$5.296 million** at March 31, 2024, primarily due to an increase in 'Other accrued expense'[69](index=69&type=chunk) [6. Alvogen Licensing Agreement](index=20&type=section&id=6.%20Alvogen%20Licensing%20Agreement) - The Company granted Alvogen an exclusive worldwide license for NRX-101 for bipolar depression with suicidality, with a term of **20 years** from first commercial sale[70](index=70&type=chunk) - Alvogen was obligated to pay an initial **$9 million** First Milestone Payment, with **$5 million** advanced in February 2024 in exchange for warrants to purchase **419,598 shares** of Common Stock[76](index=76&type=chunk) - The remaining **$4 million** of the First Milestone is due upon a positive response to the Company's planned end of phase 2 meeting with FDA[76](index=76&type=chunk) - Additional milestone payments up to **$315 million** and tiered royalties (low to mid-teens) on net sales are contingent upon regulatory approval and sales targets[76](index=76&type=chunk)[79](index=79&type=chunk) - As of March 31, 2024, the Company has not recognized any revenue from the License Agreement, and the **$5 million** advance is recorded as a refund liability of **$0.5 million** due to significant uncertainty[77](index=77&type=chunk)[86](index=86&type=chunk) [7. Debt](index=26&type=section&id=7.%20Debt) - The Company issued a 9% redeemable promissory note to Streeterville Capital, LLC for **$11.0 million** in November 2022, maturing in 18 months[87](index=87&type=chunk) - The note allows for monthly redemptions up to **$1.0 million**, payable in cash (with a 10% premium) or common stock at a discounted conversion price[88](index=88&type=chunk) - Amendments in March 2023, July 2023, and February 2024 modified redemption provisions, including cash payments and the ability to pay with common stock[91](index=91&type=chunk)[92](index=92&type=chunk)[95](index=95&type=chunk) - As of March 31, 2024, the remaining principal balance of the note was **$5.4 million**, down from **$8.3 million** at December 31, 2023[103](index=103&type=chunk) - During Q1 2024, the Company made cash payments of **$0.1 million** for interest and **$0.2 million** for redemption premiums, plus **$2.2 million** in cash principal repayments and **$0.3 million** in stock principal repayments[101](index=101&type=chunk)[102](index=102&type=chunk) - A loss of **$0.3 million** was recorded from the change in fair value of the convertible note payable for Q1 2024, compared to **$1.7 million** in Q1 2023[100](index=100&type=chunk) [8. Commitments and Contingencies](index=30&type=section&id=8.%20Commitments%20and%20Contingencies) - The Company has a license agreement with Sarah Herzog Memorial Hospital (SHMH) requiring milestone payments (up to **$0.8 million** per milestone) upon clinical trial completion and commercial sales, plus annual maintenance fees (**$0.15 million**) and royalties (1% to 2.5% of revenues)[104](index=104&type=chunk)[105](index=105&type=chunk)[107](index=107&type=chunk) - An exclusive license agreement with Apkarian Technologies for a patent on D-cycloserine for chronic pain involves future milestone and royalty payments[108](index=108&type=chunk) - The Collaboration Agreement with Relief Therapeutics for Aviptadil was settled in November 2022, transferring all ZYESAMI interest to Relief Parties in exchange for potential milestone payments up to **$13.0 million** and royalties capped at **$30.0 million**[112](index=112&type=chunk)[113](index=113&type=chunk)[115](index=115&type=chunk) - The Company is involved in various legal actions incidental to its business but believes none will have a material adverse effect on its financial position or results of operations as of the report date[119](index=119&type=chunk) [9. Equity](index=34&type=section&id=9.%20Equity) - A **1-for-10** reverse stock split was effective April 1, 2024, reducing outstanding common shares from approximately **95.7 million** to **9.6 million**[120](index=120&type=chunk)[121](index=121&type=chunk) - All **3.0 million** Series A convertible preferred stock shares were converted into **300,000 common shares** in March 2024, leaving no Series A preferred stock outstanding[123](index=123&type=chunk) - The Company issued **143,648 common shares** for **$0.4 million** in principal and interest payments on the Streeterville Note in January 2024[124](index=124&type=chunk) - From February to March 2024, the Company raised approximately **$0.2 million** net cash from ATM offerings (**34,584 shares**) and **$1.0 million** net cash from a private placement (**270,000 shares**) and warrants[125](index=125&type=chunk)[128](index=128&type=chunk) - A public offering in February 2024 raised approximately **$1.3 million** net cash (**500,000 shares**) and an additional **$0.2 million** from an overallotment exercise (**75,000 shares**)[129](index=129&type=chunk) - Warrants issued to Alvogen in February 2024 (**419,598 shares**) had a fair value of **$1.3 million**, recorded in additional paid-in capital[140](index=140&type=chunk) | Warrant Type | Outstanding as of Dec 31, 2023 | Issued (Q1 2024) | Expired (Q1 2024) | Outstanding as of Mar 31, 2024 | Weighted Average Exercise Price (Mar 31, 2024) | | :----------------------- | :----------------------------- | :--------------- | :---------------- | :----------------------------- | :--------------------------------------------- | | Total Warrants | 3,321,499 | 718,348 | (5,510) | 4,034,337 | $19.61 | [10. Stock-Based Compensation](index=40&type=section&id=10.%20Stock-Based%20Compensation) - Stock-based compensation expense decreased from **$0.695 million** in Q1 2023 to **$0.242 million** in Q1 2024[154](index=154&type=chunk) | Category | Three months ended March 31, 2024 (in thousands) | Three months ended March 31, 2023 (in thousands) | | :-------------------------- | :----------------------------------------------- | :----------------------------------------------- | | General and administrative | $211 | $591 | | Research and development | $31 | $104 | | **Total** | **$242** | **$695** | - As of March 31, 2024, total unrecognized compensation expense for stock options was **$0.3 million** (expected over **1.1 years**) and for RSAs was **$0.2 million** (expected over **1.3 years**)[150](index=150&type=chunk)[153](index=153&type=chunk) [11. Fair Value Measurements](index=43&type=section&id=11.%20Fair%20Value%20Measurements) | Description | Level | March 31, 2024 (in thousands) | December 31, 2023 (in thousands) | | :------------------------------ | :---- | :---------------------------- | :----------------------------- | | **Assets:** | | | | | Money Market Account | 1 | $566 | $3,874 | | **Liabilities:** | | | | | Warrant liabilities | 3 | $26 | $17 | | Convertible note payable | 3 | $6,779 | $9,161 | - The fair value of the convertible note payable decreased from **$9.161 million** at December 31, 2023, to **$6.779 million** at March 31, 2024, primarily due to conversions and repayments[156](index=156&type=chunk)[158](index=158&type=chunk) - Warrant liabilities increased from **$17 thousand** to **$26 thousand**, with a **$9 thousand** loss upon remeasurement in Q1 2024[156](index=156&type=chunk)[161](index=161&type=chunk) - Fair value measurements for warrant liabilities and convertible note payable use Level 3 inputs, relying on models like Black-Scholes and Monte Carlo simulations with significant management judgment[157](index=157&type=chunk)[159](index=159&type=chunk)[160](index=160&type=chunk) [12. Income Taxes](index=45&type=section&id=12.%20Income%20Taxes) - The Company recorded no provision or benefit for income tax expense for the three months ended March 31, 2024 and 2023, due to pretax losses and a valuation allowance against deferred tax assets[162](index=162&type=chunk)[163](index=163&type=chunk) [13. Related Party Transactions](index=45&type=section&id=13.%20Related%20Party%20Transactions) - The Company licenses patents from Glytech, LLC, owned by a co-founder, and paid **$0.1 million** for scientific support and patent expenses in Q1 2023 (no payment in Q1 2024)[164](index=164&type=chunk) - Dr. Jonathan Javitt, Chief Scientist and major shareholder, received **$0.2 million** in compensation in Q1 2024 (vs. **$0.3 million** in Q1 2023) under a consulting agreement[166](index=166&type=chunk) - Zachary Javitt, son of Dr. Jonathan Javitt, received **$0.1 million** in Q1 2024 (vs. **$0.1 million** in Q1 2023) for website, IT, and marketing support[170](index=170&type=chunk) [14. Subsequent Events](index=47&type=section&id=14.%20Subsequent%20Events) - In April 2024, the Company issued **73,040 common shares** to existing stockholders due to fractional share rounding from the reverse stock split[172](index=172&type=chunk) - On April 24, 2024, Streeterville Capital alleged an Event of Default on the convertible note, citing a proposed spin-off of Hope Therapeutics and failure to make a minimum payment, and filed a lawsuit seeking repayment of at least **$6.5 million**[173](index=173&type=chunk)[176](index=176&type=chunk) - In April 2024, the Company increased its ATM offering agreement by **$4.9 million** and sold an additional **$1.3 million** in common stock subsequent to March 31, 2024[177](index=177&type=chunk)[213](index=213&type=chunk) - An April 2024 public offering raised approximately **$2.0 million** gross proceeds (**607,000 shares**), with net proceeds intended for working capital, general corporate purposes, and potential repayment of the convertible note[178](index=178&type=chunk)[179](index=179&type=chunk) [ITEM 2. Management's Discussion and Analysis of Financial Condition and Results of Operations](index=49&type=section&id=ITEM%202.%20Management's%20Discussion%20and%20Analysis%20of%20Financial%20Condition%20and%20Results%20of%20Operations) Management discusses financial condition, operations, and outlook, highlighting drug pipeline, financing, and liquidity challenges [Overview](index=51&type=section&id=Overview) - NRx Pharmaceuticals is a clinical-stage biopharmaceutical company developing novel therapeutics for CNS disorders, including suicidal depression, chronic pain, and PTSD, through its subsidiaries NeuroRx (R&D) and HOPE Therapeutics (specialty pharma)[184](index=184&type=chunk) - The company reported positive Phase 2b/3 trial data for NRX-101 in Treatment Resistant Bipolar Depression, showing comparable antidepressant efficacy and a significant reduction in akathisia (P=0.025)[186](index=186&type=chunk)[188](index=188&type=chunk) - Plans are underway to file a New Drug Application (NDA) for Accelerated Approval of NRX-101 for bipolar depression patients at risk of akathisia, based on Phase 2b/3 and STABIL-B data[186](index=186&type=chunk)[188](index=188&type=chunk) - HOPE Therapeutics, a wholly-owned subsidiary, is progressing towards a separate Nasdaq listing and share dividend, focusing on an FDA-approved IV ketamine (HTX-100) for suicidal depression, with an NDA planned for H1 2024[198](index=198&type=chunk)[218](index=218&type=chunk)[219](index=219&type=chunk)[220](index=220&type=chunk) - NRX-101 received QIDP, Fast Track, and Priority Review designations for Complicated Urinary Tract Infection (cUTI) and demonstrated in vitro effectiveness against antibiotic-resistant pathogens without compromising the intestinal microbiome[203](index=203&type=chunk)[205](index=205&type=chunk) - The company secured a non-binding term sheet for up to **$7.5 million** in debt capital to replace existing debt, facilitating the proposed spin-off of HOPE, with potential for an additional **$22.5 million** for pipeline funding[186](index=186&type=chunk) [Recent Events](index=57&type=section&id=Recent%20Events) - A **1-for-10** reverse stock split became effective on April 1, 2024, retroactively adjusting all share and per share amounts[206](index=206&type=chunk) - An April 2024 public offering raised approximately **$2.0 million** gross proceeds, intended for working capital, general corporate purposes, and potential repayment of the convertible promissory note[208](index=208&type=chunk) - The ATM offering agreement was increased by **$4.9 million** in April 2024, with **$1.3 million** in additional shares sold subsequent to March 31, 2024[213](index=213&type=chunk) - February 2024 offerings, including a public offering and a private placement, generated approximately **$1.7 million** and **$1.0 million** in gross proceeds, respectively, used for working capital and debt repayment[214](index=214&type=chunk)[217](index=217&type=chunk) [Financial Results](index=61&type=section&id=Financial%20Results) | Metric | March 31, 2024 (in millions) | March 31, 2023 (in millions) | | :-------------------- | :--------------------------- | :--------------------------- | | Net loss | $(6.5) | $(11.0) | | Accumulated deficit | $(259.7) | N/A | | Stockholders' deficit | $(15.1) | N/A | | Working capital deficit | $(15.5) | N/A | - The Company incurred a net loss of **$6.5 million** for the three months ended March 31, 2024, an improvement from **$11.0 million** in the prior year period[221](index=221&type=chunk) - As of March 31, 2024, the Company had an accumulated deficit of **$259.7 million**, a stockholders' deficit of **$15.1 million**, and a working capital deficit of **$15.5 million**[221](index=221&type=chunk) [Going Concern](index=61&type=section&id=Going%20Concern) - The Company continues to generate losses and negative cash flows from operations, leading to substantial doubt about its ability to continue as a going concern for the next twelve months[222](index=222&type=chunk) - Future operations depend on securing additional equity or debt financing, strategic agreements, or licensing deals, which may dilute existing shareholders[222](index=222&type=chunk) [Nasdaq Listing Compliance](index=61&type=section&id=Nasdaq%20Listing%20Compliance) - The Company regained compliance with Nasdaq's minimum bid price requirement on April 17, 2024, following a **1-for-10** reverse stock split effective April 2, 2024[224](index=224&type=chunk) - The Company's listing was transferred from the Nasdaq Global Market to the Nasdaq Capital Market on January 19, 2024[224](index=224&type=chunk) [Components of Results of Operations](index=61&type=section&id=Components%20of%20Results%20of%20Operations) - Research and development expenses primarily consist of clinical trial costs, salaries, and stock-based compensation, expensed as incurred[225](index=225&type=chunk)[226](index=226&type=chunk) - General and administrative expenses include salaries, stock-based compensation, consultant fees, and professional fees[227](index=227&type=chunk) [Results of operations for the three months ended March 31, 2024 and 2023](index=63&type=section&id=Results%20of%20operations%20for%20the%20three%20months%20ended%20March%2031%2C%202024%20and%202023) | Metric | Three months ended March 31, 2024 (in thousands) | Three months ended March 31, 2023 (in thousands) | Change (YoY) (in thousands) | | :------------------------------------ | :----------------------------------------------- | :----------------------------------------------- | :-------------------------- | | Research and development | $1,748 | $3,650 | $(1,902) | | General and administrative | $4,250 | $5,785 | $(1,535) | | Total operating expense | $5,998 | $9,435 | $(3,437) | | Loss from operations | $(5,998) | $(9,435) | $3,437 | | Interest income | $(27) | $(156) | $129 | | Interest expense | $230 | $0 | $230 | | Change in fair value of convertible note payable | $318 | $1,772 | $(1,454) | | Change in fair value of warrant liabilities | $9 | $(12) | $21 | | Total other (income) expense | $530 | $1,604 | $(1,074) | | Net loss | $(6,528) | $(11,039) | $4,511 | - Total operating expenses decreased by **$3.437 million** (**36.4%**) year-over-year, driven by a **$1.902 million** reduction in R&D and a **$1.535 million** reduction in G&A[228](index=228&type=chunk)[229](index=229&type=chunk)[230](index=230&type=chunk) - The decrease in R&D was primarily due to a **$1.6 million** decrease in clinical trials and development expenses[229](index=229&type=chunk) - The decrease in G&A was mainly due to a **$1.2 million** decrease in insurance expense and **$0.4 million** in stock-based compensation expense[230](index=230&type=chunk) - Other expense decreased by **$1.074 million**, largely due to a **$1.454 million** reduction in the loss from the change in fair value of the convertible note payable[228](index=228&type=chunk)[233](index=233&type=chunk) [Liquidity and Capital Resources](index=65&type=section&id=Liquidity%20and%20Capital%20Resources) - The Company has no revenues and relies on equity and/or debt financing to fund operations, with no assurance of future availability on acceptable terms[235](index=235&type=chunk) - Recent financing activities include an April 2024 public offering (**$2.0 million** gross proceeds), increased ATM offering (**$4.9 million** aggregate, **$1.3 million** sold post-Q1), and February 2024 offerings (**$1.7 million** public, **$1.0 million** private)[213](index=213&type=chunk)[237](index=237&type=chunk)[239](index=239&type=chunk)[241](index=241&type=chunk) - The convertible note with Streeterville Capital had a remaining principal balance of **$5.4 million** as of March 31, 2024, with **$2.9 million** in principal, premium, and interest payments made since December 31, 2023[103](index=103&type=chunk)[248](index=248&type=chunk) - The Alvogen License Agreement provides for potential milestone payments up to **$330 million** and royalties, with a **$5 million** advance received in February 2024[255](index=255&type=chunk)[256](index=256&type=chunk) | Cash Flow Activity | Three months ended March 31, 2024 (in thousands) | Three months ended March 31, 2023 (in thousands) | | :-------------------------------- | :----------------------------------------------- | :----------------------------------------------- | | Net cash used in operating activities | $(3,671) | $(6,089) | | Net cash used in investing activities | $0 | $(4) | | Net cash provided by financing activities | $395 | $2,545 | | Net (decrease) increase in cash | $(3,276) | $(3,548) | - Operating activities used **$3.7 million** cash in Q1 2024, an improvement from **$6.1 million** in Q1 2023[259](index=259&type=chunk)[260](index=260&type=chunk) - Financing activities provided **$0.4 million** cash in Q1 2024, a decrease from **$2.5 million** in Q1 2023, due to higher debt repayments[262](index=262&type=chunk)[263](index=263&type=chunk) [Critical Accounting Policies and Significant Judgments and Estimates](index=73&type=section&id=Critical%20Accounting%20Policies%20and%20Significant%20Judgments%20and%20Estimates) - Critical accounting policies involve subjective estimates and judgments, particularly for stock-based compensation, warrant liabilities, and the convertible note payable[270](index=270&type=chunk) - Stock-based compensation fair value is estimated using the Black-Scholes model, relying on assumptions for volatility, expected term, risk-free rate, and dividend yield[272](index=272&type=chunk) - Warrant liabilities are classified as equity or liability based on specific terms, with fair value remeasurement for liability-classified warrants using Black-Scholes or modified Black-Scholes models[274](index=274&type=chunk)[275](index=275&type=chunk) - The convertible note payable is measured at fair value using a Monte Carlo simulation model, incorporating inputs like stock price, volatility, time to expiration, risk-free rate, and probability of default[276](index=276&type=chunk)[277](index=277&type=chunk) [ITEM 3. Quantitative and Qualitative Disclosures About Market Risk](index=77&type=section&id=ITEM%203.%20Quantitative%20and%20Qualitative%20Disclosures%20About%20Market%20Risk) As a smaller reporting company, NRx Pharmaceuticals is exempt from detailed market risk disclosures - The Company is exempt from providing detailed market risk disclosures as a smaller reporting company[279](index=279&type=chunk) [ITEM 4. Controls and Procedures](index=77&type=section&id=ITEM%204.%20Controls%20and%20Procedures) Management concluded disclosure controls were effective as of March 31, 2024, with no material changes in internal control - The Chief Executive Officer and Chief Financial Officer concluded that the Company's disclosure controls and procedures were effective as of March 31, 2024[282](index=282&type=chunk) - No material changes in internal control over financial reporting occurred during the three months ended March 31, 2024[284](index=284&type=chunk) PART II - OTHER INFORMATION [ITEM 1. Legal Proceedings](index=78&type=section&id=ITEM%201.%20Legal%20Proceedings) The company is involved in legal actions, detailed in Note 8, but expects no material adverse financial impact - The Company is involved in various legal actions incidental to its business, as detailed in Note 8, but does not believe any will have a material adverse effect on its financial position or results of operations[119](index=119&type=chunk)[286](index=286&type=chunk) [ITEM 1A. Risk Factors](index=78&type=section&id=ITEM%201A.%20Risk%20Factors) No material changes to risk factors were disclosed from the prior Annual Report on Form 10-K - No material changes have occurred from the risk factors previously disclosed in the Annual Report on Form 10-K for the year ended December 31, 2023[287](index=287&type=chunk) [ITEM 2. Unregistered Sales of Equity Securities and Use of Proceeds](index=78&type=section&id=ITEM%202.%20Unregistered%20Sales%20of%20Equity%20Securities%20and%20Use%20of%20Proceeds) No unregistered sales of equity securities or use of proceeds were reported for the period - No unregistered sales of equity securities or use of proceeds occurred during the reporting period[288](index=288&type=chunk) [ITEM 3. Defaults Upon Senior Securities](index=78&type=section&id=ITEM%203.%20Defaults%20Upon%20Senior%20Securities) No previously unreported defaults on senior securities occurred during Q1 2024 - No defaults upon senior securities occurred during the three months ended March 31, 2024, that were not previously reported[289](index=289&type=chunk) [ITEM 4. Mine Safety Disclosures](index=78&type=section&id=ITEM%204.%20Mine%20Safety%20Disclosures) This item is not applicable to the company - This item is not applicable[290](index=290&type=chunk) [ITEM 5. Other Information](index=78&type=section&id=ITEM%205.%20Other%20Information) No Rule 10b5-1 or non-Rule 10b5-1 trading arrangements were adopted or terminated by officers/directors - No directors or executive officers adopted or terminated Rule 10b5-1 or non-Rule 10b5-1 trading arrangements during the quarter ended March 31, 2024[291](index=291&type=chunk) [ITEM 6. Exhibits](index=78&type=section&id=ITEM%206.%20Exhibits) This section lists all exhibits filed with the Form 10-Q, including agreements, certifications, and data files - Exhibits include the Underwriting Agreement dated April 18, 2024, Form of Underwriter's Warrant, certifications of principal executive and financial officers, and interactive data files[292](index=292&type=chunk)[293](index=293&type=chunk)

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 ...

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 ...

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 ...