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AcelRx Pharmaceuticals(ACRX) - 2024 Q3 - Quarterly Report
ACRXAcelRx Pharmaceuticals(ACRX)2024-11-13 22:15

Financial Performance - Total revenue for the three months ended September 30, 2024, was 117,000,comparedto117,000, compared to 370,000 for the same period in 2023, representing a decrease of 68.4%[13] - The net loss for the three months ended September 30, 2024, was 3,353,000,comparedtoanetlossof3,353,000, compared to a net loss of 1,357,000 for the same period in 2023, indicating a deterioration of 146.5%[13] - Basic and diluted loss per share for continuing operations was (0.13)forthethreemonthsendedSeptember30,2024,comparedto(0.13) for the three months ended September 30, 2024, compared to (0.08) for the same period in 2023[13] - As of September 30, 2023, the company reported a net loss of 1,357,000,withtotalequityamountingto1,357,000, with total equity amounting to 18,307,000[15] - The company recognized a net loss from discontinued operations of 8,098thousandfortheninemonthsendedSeptember30,2023,withtotalrevenuesfromdiscontinuedoperationsat8,098 thousand for the nine months ended September 30, 2023, with total revenues from discontinued operations at 501 thousand[47] Expenses and Costs - Research and development expenses for the three months ended September 30, 2024, were 2,053,000,anincreaseof74.42,053,000, an increase of 74.4% from 1,178,000 in the same period of 2023[13] - Total operating costs and expenses for the three months ended September 30, 2024, were 3,749,000,comparedto3,749,000, compared to 3,426,000 for the same period in 2023, reflecting an increase of 9.4%[13] - The Company recorded total stock-based compensation expense of 234,000forthethreemonthsendedSeptember30,2024,comparedto234,000 for the three months ended September 30, 2024, compared to 378,000 for the same period in 2023[79] - The total stock-based compensation expense for the nine months ended September 30, 2024, was 759,000,downfrom759,000, down from 1,418,000 for the same period in 2023[79] Equity and Liabilities - Total stockholders' equity decreased to 9,641,000asofSeptember30,2024,downfrom9,641,000 as of September 30, 2024, down from 14,105,000 as of December 31, 2023[10] - The accumulated deficit increased to (455,360,000)asofSeptember30,2024,comparedto(455,360,000) as of September 30, 2024, compared to (444,226,000) as of December 31, 2023[10] - The company reported total liabilities and stockholders' equity of 21,014,000asofSeptember30,2024,comparedto21,014,000 as of September 30, 2024, compared to 20,395,000 as of December 31, 2023[10] Cash Flow and Financing - The company experienced a net cash used in operating activities of 10,429,000fortheninemonthsendedSeptember30,2023,comparedto10,429,000 for the nine months ended September 30, 2023, compared to 13,543,000 for the same period in the previous year[16] - The company had cash and cash equivalents of 11,117,000attheendofthereportingperiod,downfrom11,117,000 at the end of the reporting period, down from 13,389,000 at the beginning of the period[16] - The company raised 5,884,000fromtheissuanceofcommonstockrelatedtotheexerciseofprefundedwarrantsduringthereportingperiod[16]−Managementplanstoseekadditionalcapitalthroughvariousmeans,includingpublicorprivateequityofferingsandpotentialassetmonetization[24]ProductDevelopmentandStrategy−Thecompanyisfocusedonadvancingthedevelopmentofitsleadproductcandidate,Niyad™,andaimstosecureregulatoryapprovalandcommercialization[6]−Thecompanyisfocusedondevelopinginnovativetherapies,includingNiyad™andLTX−608,targetingconditionssuchasacuterespiratorydistresssyndromeanddisseminatedintravascularcoagulation[18]−Thecompanyhasaproductdevelopmentpipelinethatincludesalicenseagreementforephedrineandphenylephrinepre−filledsyringes,pendingFDAapproval[22]RisksandConcerns−Thecompanyfacessignificantrisksincludingmarketvolatility,supplychaindisruptions,andtheabilitytoobtainnecessaryfinancingforoperations[6]−Thecompanyhasincurredrecurringoperatinglossesandnegativecashflowssinceinception,raisingconcernsaboutitsabilitytocontinueasagoingconcern[23]−TheCompanymayneedtoreduceitsworkforceordelayclinicaltrialsifadequatefundsarenotavailable[25]AccountingandFinancialReporting−TheCompanyisevaluatingtheimpactofnewaccountingstandards,includingASU2023−07andASU2023−09,butdoesnotexpectthemtomateriallyaffectfinancialstatements[34][35]−TheCompanyhasreclassifiedcertainprioryearamountsinitsfinancialstatementstoconformtocurrentyearpresentation[29]−TheCompanybelievesitsmostsignificantaccountingestimatesrelatetorevenuerecognitionandimpairmentoflong−livedassets[28]StockandWarrants−AsofSeptember30,2024,theCompanyhad29,474,257warrantsoutstanding,withaweightedaverageexercisepriceof5,884,000 from the issuance of common stock related to the exercise of prefunded warrants during the reporting period[16] - Management plans to seek additional capital through various means, including public or private equity offerings and potential asset monetization[24] Product Development and Strategy - The company is focused on advancing the development of its lead product candidate, Niyad™, and aims to secure regulatory approval and commercialization[6] - The company is focused on developing innovative therapies, including Niyad™ and LTX-608, targeting conditions such as acute respiratory distress syndrome and disseminated intravascular coagulation[18] - The company has a product development pipeline that includes a license agreement for ephedrine and phenylephrine pre-filled syringes, pending FDA approval[22] Risks and Concerns - The company faces significant risks including market volatility, supply chain disruptions, and the ability to obtain necessary financing for operations[6] - The company has incurred recurring operating losses and negative cash flows since inception, raising concerns about its ability to continue as a going concern[23] - The Company may need to reduce its workforce or delay clinical trials if adequate funds are not available[25] Accounting and Financial Reporting - The Company is evaluating the impact of new accounting standards, including ASU 2023-07 and ASU 2023-09, but does not expect them to materially affect financial statements[34][35] - The Company has reclassified certain prior year amounts in its financial statements to conform to current year presentation[29] - The Company believes its most significant accounting estimates relate to revenue recognition and impairment of long-lived assets[28] Stock and Warrants - As of September 30, 2024, the Company had 29,474,257 warrants outstanding, with a weighted average exercise price of 0.96 per share[75] - The Company amended its 2020 Equity Incentive Plan to increase the number of authorized shares by 1,171,395, bringing the total to 3,161,395 shares[72] - The Company amended its 2011 Employee Stock Purchase Plan to increase the number of authorized shares by 100,000, totaling 345,000 shares[74] - The basic net loss per share of common stock is calculated by dividing the net loss by the weighted average number of shares outstanding for the period[83] - A total of 2,096,052 common stock equivalents were excluded from the computation of diluted net loss per share for the three months ended September 30, 2024, due to antidilutive effects[84]