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NRX Pharmaceuticals(NRXP) - 2024 Q4 - Annual Report

Financing and Capital Structure - NRx Pharmaceuticals closed 10.87millionindebtcapitalfinancingin2024andanadditional10.87 million in debt capital financing in 2024 and an additional 8.5 million in January 2025, totaling 16.3millionfrominstitutionalinvestors[472].TheCompanysecured16.3 million from institutional investors[472]. - The Company secured 8.5 million in new financing subsequent to December 31, 2024, to support working capital requirements through the end of fiscal year 2025[498]. - The Company entered into a securities purchase agreement on January 27, 2025, for the sale of 1,215,278 shares at a purchase price of 2.88pershare,generatinggrossproceedsofapproximately2.88 per share, generating gross proceeds of approximately 3.5 million[499][500]. - The Company executed an agreement on August 12, 2024, to sell and issue 16.3millionofNotesandWarrants,withproceedsusedtosettleoutstandingamountsowedandforworkingcapitalneeds[532].TheCompanycompletedtheFebruary2024PublicOfferingwithgrossproceedsofapproximately16.3 million of Notes and Warrants, with proceeds used to settle outstanding amounts owed and for working capital needs[532]. - The Company completed the February 2024 Public Offering with gross proceeds of approximately 1.7 million, selling shares at a public offering price of 3.00each,whileunderwriterspurchasedat3.00 each, while underwriters purchased at 2.76 per share[537]. - The February 2024 Private Placement raised approximately 1.0millionbyissuing270,000sharesatapriceof1.0 million by issuing 270,000 shares at a price of 3.80 per share, representing a 26.7% premium to the public offering price[539]. - Financing activities provided 7.485millionincashduring2024,primarilyfromtheissuanceofcommonstockandwarrants,offsetby7.485 million in cash during 2024, primarily from the issuance of common stock and warrants, offset by 7.9 million in repayments of convertible notes[545]. Research and Development - The company initiated a New Drug Application (NDA) for NRX-101 in Q4 2024, with an anticipated FDA decision date by June 30, 2025[474]. - NRX-101 received Qualified Infectious Disease Product designation and Fast Track designation for treating Complicated Urinary Tract Infection[479]. - The company is developing HTX-100, a novel pH neutral formulation of ketamine, expected to begin clinical testing by 2026[477]. - For the year ended December 31, 2024, the company recorded 6.2millioninresearchanddevelopmentexpenses,adecreaseof6.2 million in research and development expenses, a decrease of 7.2 million from 13.4millionin2023,primarilyduetotheconclusionofthephase2studyrelatedtoNRX101[519].TheCompanyhasacontractualobligationtopaymilestonepaymentsof13.4 million in 2023, primarily due to the conclusion of the phase 2 study related to NRX-101[519]. - The Company has a contractual obligation to pay milestone payments of 0.3 million upon completion of phase 3 trials for NRX-101, along with ongoing royalties of 1% to 2.5% of gross sales[548]. Financial Performance - For the years ended December 31, 2024 and 2023, NRx Pharmaceuticals reported net losses of 25.1millionand25.1 million and 30.2 million, respectively[506]. - The company reported a net loss of 25.1millionfortheyearendedDecember31,2024,animprovementof25.1 million for the year ended December 31, 2024, an improvement of 5.0 million from a net loss of 30.2millionin2023[518].ThenetcashusedinoperatingactivitiesfortheyearendedDecember31,2024,wasapproximately30.2 million in 2023[518]. - The net cash used in operating activities for the year ended December 31, 2024, was approximately 10.6 million, resulting from a net loss of 25.1million[542].TheCompanyreportedanetcashdecreaseof25.1 million[542]. - The Company reported a net cash decrease of 3.152 million for the year ended December 31, 2024, compared to a decrease of 15.459millionin2023[542].TheCompanyhasgeneratednorevenuesandexpectstocontinueincurringsignificantoperatinglosses,relyingonequityand/ordebtfinancingtocontinueoperations[527].TheCompanyhasnorevenuesandhassufferedoperatinglossessinceinception,raisingsubstantialdoubtaboutitsabilitytocontinueasagoingconcern[569].AssetsandLiabilitiesAsofDecember31,2024,NRxPharmaceuticalshadanaccumulateddeficitof15.459 million in 2023[542]. - The Company has generated no revenues and expects to continue incurring significant operating losses, relying on equity and/or debt financing to continue operations[527]. - The Company has no revenues and has suffered operating losses since inception, raising substantial doubt about its ability to continue as a going concern[569]. Assets and Liabilities - As of December 31, 2024, NRx Pharmaceuticals had an accumulated deficit of 278.3 million and a stockholders' deficit of 23.5million[506].AsofDecember31,2024,theCompanyreportedtotalassetsof23.5 million[506]. - As of December 31, 2024, the Company reported total assets of 3.651 million, a decrease from 7.315millionin2023,andtotalliabilitiesincreasedto7.315 million in 2023, and total liabilities increased to 26.874 million from 19.048million[542].TheCompanyincurredaworkingcapitaldeficitof19.048 million[542]. - The Company incurred a working capital deficit of 18.8 million as of December 31, 2024[506]. - The Company reported a working capital deficit as of December 31, 2024[569]. Compliance and Regulatory Matters - The Nasdaq Stock Market notified the Company on July 20, 2023, regarding non-compliance with the minimum market value of listed securities requirement of 50million[510].ThecompanyreceivedawrittennotificationfromNasdaqonAugust6,2024,indicatingnoncompliancewiththeminimummarketvalueoflistedsecuritiesrequirementof50 million[510]. - The company received a written notification from Nasdaq on August 6, 2024, indicating non-compliance with the minimum market value of listed securities requirement of 35 million for 33 consecutive business days[512]. - The Company transferred its listing from the Nasdaq Global Market to the Nasdaq Capital Market on January 19, 2024, after receiving an exception to the Nasdaq Listing Rules[511]. Strategic Initiatives - A non-binding offer was accepted for licensing NRX-100, which includes potential milestones of 325millionandroyaltiesrangingfrom11325 million and royalties ranging from 11% to 16% of sales[474]. - NRx is negotiating to acquire three precision psychiatry centers and six additional centers to expand its HOPE network[477]. - The company anticipates expanding its treatment offerings to include PTSD by year-end 2025, contingent on successful acquisitions[477]. - NRx engaged BTIG to identify additional clinic candidates to meet projected revenue targets by the end of 2025[477]. - The Company is negotiating with a publicly-traded entity for acquisition capital to support the expansion of HOPE, aiming to finance less than 50% of the proposed acquisition costs[504]. Operational Expenses - General and administrative expenses for the year ended December 31, 2024, were 13.5 million, down from 14.2millionin2023,reflectingadecreaseof14.2 million in 2023, reflecting a decrease of 0.7 million[520]. - The total operating expenses for the year ended December 31, 2024, were 18.5million,areductionof18.5 million, a reduction of 9.3 million compared to 27.8millionin2023[518].OtherFinancialMattersTheCompanyrecordedadefaultpenaltyof27.8 million in 2023[518]. Other Financial Matters - The Company recorded a default penalty of 0.8 million for the year ended December 31, 2024, due to alleged default in connection with the Streeterville convertible note[523]. - The fair value of the convertible note was estimated using a Monte Carlo simulation model, which is complex and subjective[575][576]. - The valuation of the convertible note as of December 31, 2024, was identified as a critical audit matter[576]. - Management's estimate of the fair value of the convertible note was agreed upon after independent testing of data and assumptions[577].