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Cidara Therapeutics(CDTX) - 2024 Q3 - Quarterly Results

Financial Performance - Revenue was zero for the three months ended September 30, 2024, and 1.3millionfortheninemonthsendedSeptember30,2024,comparedto1.3 million for the nine months ended September 30, 2024, compared to 9.2 million and 20.5millionforthesameperiodsin2023,respectively[3].NetlossforthethreeandninemonthsendedSeptember30,2024,was20.5 million for the same periods in 2023, respectively [3]. - Net loss for the three and nine months ended September 30, 2024, was 16.0 million and 117.5million,respectively,comparedtoanetlossof117.5 million, respectively, compared to a net loss of 9.1 million and 19.7millionforthesameperiodsin2023[5].TotalrevenuesforthethreemonthsendedSeptember30,2024,were19.7 million for the same periods in 2023 [5]. - Total revenues for the three months ended September 30, 2024, were 0, compared to 9,217,000forthesameperiodin2023,representingadecreaseof1009,217,000 for the same period in 2023, representing a decrease of 100% [10]. - The net loss for the three months ended September 30, 2024, was 15,985,000, compared to a net loss of 9,107,000in2023,indicatingawideningof75.59,107,000 in 2023, indicating a widening of 75.5% [10]. - Basic and diluted net loss per common share from continuing operations was (2.38) for the three months ended September 30, 2024, compared to (0.85)in2023[10].BasicanddilutednetlosspercommonsharefortheninemonthsendedSeptember30,2024,was(0.85) in 2023 [10]. - Basic and diluted net loss per common share for the nine months ended September 30, 2024, was (22.61), compared to (3.91)in2023,indicatingasignificantincreaseinlosses[10].ExpensesResearchanddevelopmentexpenseswere(3.91) in 2023, indicating a significant increase in losses [10]. Expenses - Research and development expenses were 12.4 million for the three months ended September 30, 2024, compared to 10.4 million for the same period in 2023, primarily due to higher expenses associated with the CD388 Phase 2b NAVIGATE study [3]. - Selling, general and administrative (SG&A) expenses were 5.0 million for the three months ended September 30, 2024, compared to 3.3millionforthesameperiodin2023[3].TotaloperatingexpensesforthethreemonthsendedSeptember30,2024,were3.3 million for the same period in 2023 [3]. - Total operating expenses for the three months ended September 30, 2024, were 17,394,000, compared to 13,685,000in2023,markinganincreaseof27.513,685,000 in 2023, marking an increase of 27.5% [10]. - Research and development expenses increased to 12,429,000 for the three months ended September 30, 2024, up from 10,386,000in2023,reflectingagrowthof19.710,386,000 in 2023, reflecting a growth of 19.7% [10]. - Acquired in-process research and development expenses were 84.9 million for the nine months ended September 30, 2024, related to an upfront payment of 85.0millionpaidtoJanssenundertheJanssenLicenseAgreement[3].CashandAssetsCashandcashequivalentstotaled85.0 million paid to Janssen under the Janssen License Agreement [3]. Cash and Assets - Cash and cash equivalents totaled 127.4 million as of September 30, 2024, compared to 35.8millionasofDecember31,2023[3].CashandcashequivalentsasofSeptember30,2024,were35.8 million as of December 31, 2023 [3]. - Cash and cash equivalents as of September 30, 2024, were 127,386,000, significantly up from 35,778,000asofDecember31,2023,showinganincreaseof255.535,778,000 as of December 31, 2023, showing an increase of 255.5% [11]. - Total assets increased to 162,331,000 as of September 30, 2024, compared to 67,030,000attheendof2023,representingagrowthof142.567,030,000 at the end of 2023, representing a growth of 142.5% [11]. - Total liabilities decreased to 46,701,000 as of September 30, 2024, down from 75,240,000atDecember31,2023,reflectingareductionof37.975,240,000 at December 31, 2023, reflecting a reduction of 37.9% [11]. - Total stockholders' equity improved to 115,630,000 as of September 30, 2024, compared to a deficit of 8,210,000atDecember31,2023[11].ClinicalDevelopmentCidarainitiatedaPhase2bNAVIGATEtrialtargetingenrollmentof5,000healthy,unvaccinatedadultsubjectsforCD388,withsubjectsbeingfollowedfortheremainderoftheinfluenzaseason[1].CidarasleadDFCcandidate,CD388,receivedFastTrackDesignationfromtheFDAinJune2023,andthecompanyannouncedtheinitiationofaPhase2btrialinSeptember2024[7].Cidararestructureditsworkforcewithanapproximate308,210,000 at December 31, 2023 [11]. Clinical Development - Cidara initiated a Phase 2b NAVIGATE trial targeting enrollment of 5,000 healthy, unvaccinated adult subjects for CD388, with subjects being followed for the remainder of the influenza season [1]. - Cidara's lead DFC candidate, CD388, received Fast Track Designation from the FDA in June 2023, and the company announced the initiation of a Phase 2b trial in September 2024 [7]. - Cidara restructured its workforce with an approximate 30% reduction to focus on the clinical development of CD388 [2]. Discontinued Operations - The sale of rezafungin assets to Napp Pharmaceutical Group Limited is classified as discontinued operations, with a net loss from discontinued operations of 0.5 million for the three months ended September 30, 2024 [5].