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BioCardia(BCDA) - 2024 Q3 - Quarterly Report
BCDABioCardia(BCDA)2024-11-13 21:05

Financial Performance - Net loss for the three months ended September 30, 2024, was 1,737,000,adecreasefromanetlossof1,737,000, a decrease from a net loss of 2,574,000 for the same period in 2023, reflecting a 32.6% improvement[12] - Net loss per share improved to (0.61)forthethreemonthsendedSeptember30,2024,comparedto(0.61) for the three months ended September 30, 2024, compared to (1.79) for the same period in 2023, a 66.1% enhancement[12] - As of September 30, 2024, BioCardia, Inc. reported a net loss of 5.65million,adecreasefromanetlossof5.65 million, a decrease from a net loss of 9.5 million for the same period in 2023, representing a 40% improvement[16] - The company has incurred net losses and negative cash flows from operations since inception, with expectations of continued losses as clinical trials advance[24] - As of September 30, 2024, the company had an accumulated deficit of approximately 157.8millionandanticipatescontinuingtoincurnetlossesforthenextseveralyears[89]AssetsandLiabilities−Totalcurrentassetsincreasedto157.8 million and anticipates continuing to incur net losses for the next several years[89] Assets and Liabilities - Total current assets increased to 5,056,000 as of September 30, 2024, compared to 1,461,000asofDecember31,2023,representingagrowthof2461,461,000 as of December 31, 2023, representing a growth of 246%[10] - Cash and cash equivalents increased significantly to 4,930,000 as of September 30, 2024, compared to 1,103,000asofDecember31,2023,markingariseof3461,103,000 as of December 31, 2023, marking a rise of 346%[10] - Total liabilities decreased to 3,514,000 as of September 30, 2024, from 4,590,000asofDecember31,2023,showingareductionof23.44,590,000 as of December 31, 2023, showing a reduction of 23.4%[10] - Total stockholders' equity improved to 2,753,000 as of September 30, 2024, from a deficit of (1,603,000)asofDecember31,2023,indicatingapositiveshiftinequity[10]−CashandcashequivalentsasofSeptember30,2024wereapproximately(1,603,000) as of December 31, 2023, indicating a positive shift in equity[10] - Cash and cash equivalents as of September 30, 2024 were approximately 4.9 million[89] Research and Development - Research and development expenses for the nine months ended September 30, 2024, totaled 2,972,000,downfrom2,972,000, down from 6,570,000 for the same period in 2023, indicating a reduction of 54.7%[12] - BioCardia's CardiAMP® therapy platform is in pivotal trials for ischemic heart failure with reduced ejection fraction (HFrEF) and refractory angina, targeting significant unmet medical needs[18] - The company has been focusing on research and development of cellular and cell-derived therapeutics for cardiovascular and pulmonary diseases[18] - The company plans to increase research and development expenses to continue pivotal trials for CardiAMP and CardiALLO cell therapies[80] Financing Activities - BioCardia's financing activities generated 9.29millioninnetcashfortheninemonthsendedSeptember30,2024,comparedto9.29 million in net cash for the nine months ended September 30, 2024, compared to 2.61 million in the prior year[16] - The company raised gross proceeds of 7.2millionfromapublicofferingonSeptember3,2024,withassociatedissuancecostsof7.2 million from a public offering on September 3, 2024, with associated issuance costs of 926,000[42] - The company sold 412,239 shares under ATM offerings during the nine months ended September 30, 2024, generating approximately 2.4millioningrossproceeds[46]−Netcashprovidedbyfinancingactivitieswasapproximately2.4 million in gross proceeds[46] - Net cash provided by financing activities was approximately 9.3 million for the nine months ended September 30, 2024, compared to approximately 2.6millionforthesameperiodin2023[91]OperationalChallenges−BioCardia,Inc.planstoraiseadditionalcapitaltofundoperationsbeyondthesecondquarterof2025,ascurrentcashreservesareinsufficient[25]−Thecompanyanticipatesneedingadditionalfundingtocontinuethedevelopmentofitstherapeuticcandidates,potentiallythroughnon−dilutivecollaboration,licensingarrangements,ordebt/equityfinancing[98]−Thereissubstantialdoubtaboutthecompany′sabilitytocontinueasagoingconcernwithinoneyear,heavilyreliantonitsabilitytoraiseadditionalcapital[102]−Ifthecompanycannotsecureadequatefunds,itmayneedtoreduceoperatingexpensesorceaseoperations[102]Share−BasedCompensation−Thecompanyreportedshare−basedcompensationexpensesof2.6 million for the same period in 2023[91] Operational Challenges - BioCardia, Inc. plans to raise additional capital to fund operations beyond the second quarter of 2025, as current cash reserves are insufficient[25] - The company anticipates needing additional funding to continue the development of its therapeutic candidates, potentially through non-dilutive collaboration, licensing arrangements, or debt/equity financing[98] - There is substantial doubt about the company's ability to continue as a going concern within one year, heavily reliant on its ability to raise additional capital[102] - If the company cannot secure adequate funds, it may need to reduce operating expenses or cease operations[102] Share-Based Compensation - The company reported share-based compensation expenses of 565,000 for the nine months ended September 30, 2024, down from 846,000inthesameperiodof2023[16]−Share−basedcompensationexpenseforQ32024was846,000 in the same period of 2023[16] - Share-based compensation expense for Q3 2024 was 177,000, a decrease of 29.4% from 251,000inQ32023[8]−Totalshare−basedcompensationfortheninemonthsendedSeptember30,2024,was251,000 in Q3 2023[8] - Total share-based compensation for the nine months ended September 30, 2024, was 565,000, down 33.2% from 846,000inthesameperiodof2023[8]−Unrecognizedshare−basedcompensationforoptionsgrantedthroughSeptember30,2024,is846,000 in the same period of 2023[8] - Unrecognized share-based compensation for options granted through September 30, 2024, is 837,000, to be recognized over 1.8 years[49] Clinical Trials and Product Development - The CardiAMP Heart Failure Trial enrolled 115 patients, with final data transfer expected in Q1 2025[61] - Interim results of the CardiAMP Heart Failure II Trial showed an 86% relative risk reduction in mortality[63] - The CardiAMP Cell Therapy Chronic Myocardial Ischemia Trial is designed to enroll up to 343 patients, focusing on refractory angina[68] - The open-label roll-in cohort for chronic myocardial ischemia showed an average 107-second increase in exercise tolerance and an 82% reduction in angina episodes[69] - The FDA approved a protocol amendment for the CardiAMP Heart Failure II Trial, allowing more patients to receive treatment[65] - The FDA approved the Morph-DNA product family for market release in August 2024, with first commercial devices expected in November 2024[75] - The company has entered into biotherapeutic delivery partnerships, including a Phase I/II Clinical Study with StemCardia, expected to enhance future treatment options for heart disease[73] Lease and Operating Expenses - The operating lease expense was 121,000forboththethreemonthsendedSeptember30,2024,and2023,and121,000 for both the three months ended September 30, 2024, and 2023, and 362,000 for both the nine months ended September 30, 2024, and 2023[37] - Future minimum lease payments under the operating lease total 1.18millionasofSeptember30,2024,withtotaloperatingleaseliabilitiesat1.18 million as of September 30, 2024, with total operating lease liabilities at 1.05 million[38] - The company’s weighted average remaining lease term was 2.34 years, with a weighted average discount rate of 10.74% as of September 30, 2024[37] Revenue - Revenue for the three months ended September 30, 2024 was 0,comparedto0, compared to 357,000 for the same period in 2023, and for the nine months ended September 30, 2024, revenue decreased to 58,000from58,000 from 464,000 in 2023[86]