NRX Pharmaceuticals(NRXP) - 2023 Q3 - Quarterly Report

PART I - FINANCIAL INFORMATION ITEM 1. Financial Statements 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 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] - 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] - Stockholders' equity shifted from a positive $7.409 million to a deficit of $(6.217) million[9] Unaudited Condensed Consolidated Statements of Operations and Comprehensive Loss 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] - 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] Unaudited Condensed Consolidated Statements of Changes in Stockholders' (Deficit) Equity 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] - This decline was primarily due to recurring net losses, partially offset by proceeds from common stock, warrants, and preferred stock issuances[16] Unaudited Condensed Consolidated Statements of Cash Flows 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] - 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] Notes to Unaudited Condensed Consolidated Financial Statements This section provides detailed explanations and disclosures supporting the unaudited condensed consolidated financial statements 1. Organization 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][24][219] - 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][24][219] - NRX-101 Development: Expanded from suicidal bipolar depression to include Chronic Pain and Complicated Urinary Tract Infection (cUTI)[25][26][27] - The ongoing Phase 2b/3 trial for Treatment-Resistant Bipolar Depression (TRBD) is nearing enrollment completion, with results potentially usable for registrational filings[25][26][27] - 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][35] - A development and manufacturing agreement with Nephron Pharmaceuticals aims to create a single-patient, diversion-resistant ketamine presentation[38][39][40][41][42][43][44] - **New Therapeutic Targets