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 ...

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 ...