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Taysha Gene Therapies(TSHA) - 2024 Q3 - Quarterly Results
TSHATaysha Gene Therapies(TSHA)2024-11-13 21:10

Financial Performance - Net loss for Q3 2024 was 25.5million,or25.5 million, or 0.1 per share, significantly reduced from a net loss of 117.1million,or117.1 million, or 0.93 per share, in Q3 2023[8]. - Revenue for the three months ended September 30, 2024, was 1,788,000,comparedto1,788,000, compared to 4,746,000 for the same period in 2023, representing a decrease of 62.4%[15]. - Net loss for the three months ended September 30, 2024, was 25,524,000,comparedtoanetlossof25,524,000, compared to a net loss of 117,087,000 for the same period in 2023[15]. - Total operating expenses for the nine months ended September 30, 2024, were 77,838,000,upfrom77,838,000, up from 68,040,000 in 2023, an increase of 14.5%[15]. - Research and development expenses for the three months ended September 30, 2024, were 14,946,000,comparedto14,946,000, compared to 11,791,000 for the same period in 2023, an increase of 26.5%[15]. - General and administrative expenses for the nine months ended September 30, 2024, were 22,324,000,downfrom22,324,000, down from 23,328,000 in 2023, a decrease of 4.3%[15]. Cash and Assets - As of September 30, 2024, Taysha had 157.7millionincashandcashequivalents,expectedtosupportoperationsintoQ42026[9].−Cashandcashequivalentsincreasedto157.7 million in cash and cash equivalents, expected to support operations into Q4 2026[9]. - Cash and cash equivalents increased to 157,688,000 as of September 30, 2024, from 143,940,000asofDecember31,2023[16].−Totalassetsroseto143,940,000 as of December 31, 2023[16]. - Total assets rose to 180,217,000 as of September 30, 2024, compared to 172,731,000asofDecember31,2023[16].−Totalliabilitiesdecreasedto172,731,000 as of December 31, 2023[16]. - Total liabilities decreased to 91,420,000 as of September 30, 2024, from 97,794,000asofDecember31,2023,areductionof6.497,794,000 as of December 31, 2023, a reduction of 6.4%[16]. - Additional paid-in capital increased to 674,643,000 as of September 30, 2024, from 587,942,000asofDecember31,2023[16].−Accumulateddeficitincreasedto587,942,000 as of December 31, 2023[16]. - Accumulated deficit increased to 583,520,000 as of September 30, 2024, compared to 513,007,000asofDecember31,2023[16].ClinicalDevelopment−TSHA−102highdosewasgenerallywelltoleratedwithnoseriousadverseevents(SAEs)ordose−limitingtoxicities(DLTs)reportedintwoadolescent/adultpatientsandonepediatricpatientasofdatacutoff[1].−ClinicaldatafromthelowdosecohortofTSHA−102indicatedearlyclinicalimprovementsandfunctionalgainsacrossmultipledomainswithinfourweekspost−treatment,withsustainedimprovementsovertime[4].−TheFDAapprovedtheuseofthepivotalTSHA−102productinREVEALtrialsbasedonsuccessfulanalyticalcomparability,allowingforthefinalcommercialmanufacturingprocess[3].−AnticipatedsafetyandefficacydatafrombothhighandlowdosecohortsoftheREVEALtrialsareexpectedinthefirsthalfof2025[6].−TheIndependentDataMonitoringCommittee(IDMC)approvedcontinuedenrollmentinthehighdosecohortacrossbothREVEALtrials,witheightpatientsdosedtodate[1].−ThecompanyplanstofocusonobjectivemeasuresforfunctionalgainsintheREVEALtrials,excludingtheRettSyndromeBehaviorQuestionnaireasaprimaryorsecondaryendpoint[3].−TayshaaimstoexpeditethedevelopmentplanforTSHA−102throughongoingdiscussionswiththeFDAregardingtrialdesignandendpoints[2].ResearchandDevelopmentExpenses−ResearchanddevelopmentexpensesforQ32024were513,007,000 as of December 31, 2023[16]. Clinical Development - TSHA-102 high dose was generally well tolerated with no serious adverse events (SAEs) or dose-limiting toxicities (DLTs) reported in two adolescent/adult patients and one pediatric patient as of data cutoff[1]. - Clinical data from the low dose cohort of TSHA-102 indicated early clinical improvements and functional gains across multiple domains within four weeks post-treatment, with sustained improvements over time[4]. - The FDA approved the use of the pivotal TSHA-102 product in REVEAL trials based on successful analytical comparability, allowing for the final commercial manufacturing process[3]. - Anticipated safety and efficacy data from both high and low dose cohorts of the REVEAL trials are expected in the first half of 2025[6]. - The Independent Data Monitoring Committee (IDMC) approved continued enrollment in the high dose cohort across both REVEAL trials, with eight patients dosed to date[1]. - The company plans to focus on objective measures for functional gains in the REVEAL trials, excluding the Rett Syndrome Behavior Questionnaire as a primary or secondary endpoint[3]. - Taysha aims to expedite the development plan for TSHA-102 through ongoing discussions with the FDA regarding trial design and endpoints[2]. Research and Development Expenses - Research and development expenses for Q3 2024 were 14.9 million, an increase of 3.1millionfrom3.1 million from 11.8 million in Q3 2023, driven by GMP batch activities and increased compensation for R&D employees[6].