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Tenaya Therapeutics(TNYA) - 2024 Q3 - Quarterly Report

Financial Performance - Total operating expenses for Q3 2024 were 26.7million,downfrom26.7 million, down from 30.9 million in Q3 2023, reflecting a decrease of 4.2million,or144.2 million, or 14%[66]. - The net loss for Q3 2024 was 25.6 million, compared to a net loss of 29.1millioninQ32023,representinganimprovementof29.1 million in Q3 2023, representing an improvement of 3.5 million, or 12%[66]. - Net loss for the nine months ended September 30, 2024, was 87.3million,comparedtoanetlossof87.3 million, compared to a net loss of 94.1 million for the same period in 2023, reflecting an improvement of 6.8millionor76.8 million or 7%[77]. - Total operating expenses for the nine months ended September 30, 2024, were 91.3 million, down from 99.7millionin2023,adecreaseof99.7 million in 2023, a decrease of 8.5 million or 8%[72]. - Cash, cash equivalents, and investments in marketable securities totaled 79.5millionasofSeptember30,2024,withanaccumulateddeficitof79.5 million as of September 30, 2024, with an accumulated deficit of 490.6 million[78]. - Net cash used in operating activities for the nine months ended September 30, 2024, was 72.1million,comparedto72.1 million, compared to 80.1 million in 2023, indicating a reduction of 8.0million[86].NetcashprovidedbyfinancingactivitiesfortheninemonthsendedSeptember30,2024,was8.0 million[86]. - Net cash provided by financing activities for the nine months ended September 30, 2024, was 47.4 million, primarily from a follow-on offering, compared to 3.7millionin2023[88].ResearchandDevelopmentResearchanddevelopmentexpensesdecreasedby3.7 million in 2023[88]. Research and Development - Research and development expenses decreased by 2.7 million, or 12%, from 23.1millioninQ32023to23.1 million in Q3 2023 to 20.4 million in Q3 2024, primarily due to a workforce reduction plan and lower costs for outside lab services[69]. - Research and development expenses decreased to 68.1millionfortheninemonthsendedSeptember30,2024,from68.1 million for the nine months ended September 30, 2024, from 75.2 million in 2023, a reduction of 7.1millionor97.1 million or 9%[74]. - The company continues to invest in new technologies and optimization of existing capabilities to support the development of gene therapies[63]. - The company has initiated the MyPEAK-1 Phase 1b/2 clinical trial for TN-201, with initial data expected in December 2024[62]. - TN-401 received FDA clearance for clinical testing and patient dosing is planned to begin in Q4 2024[63]. - TN-301 showed positive data in a Phase 1 clinical trial, indicating it was well tolerated and demonstrated dose proportionality[63]. - The company has received rare pediatric disease designation and orphan drug designation for TN-201 from the FDA[63]. - The Genetic Medicines Manufacturing Center is strategically located to support clinical studies and enhance manufacturing productivity[65]. Expenses and Cost Management - General and administrative expenses decreased by 1.5 million, or 19%, from 7.8millioninQ32023to7.8 million in Q3 2023 to 6.4 million in Q3 2024, driven by reductions in employee-related costs and lower professional fees[70]. - General and administrative expenses were 23.2millionfortheninemonthsendedSeptember30,2024,downfrom23.2 million for the nine months ended September 30, 2024, down from 24.6 million in 2023, a decrease of 1.3millionor51.3 million or 5%[75]. - The company expects to continue incurring operating losses in the foreseeable future, with operating expenses anticipated to remain relatively flat for the next twelve months[83]. Company Classification and Compliance - The company is classified as an emerging growth company under the JOBS Act, remaining so until it exceeds 1.235 billion in annual revenue or meets other specified criteria[93]. - The company is also a smaller reporting company, with a market value of stock held by non-affiliates below 700millionandannualrevenueunder700 million and annual revenue under 100 million in the most recently completed fiscal year[93]. - The company may continue to qualify as a smaller reporting company if its market value remains below 250millionorifitmaintainsannualrevenuebelow250 million or if it maintains annual revenue below 100 million[93]. - As a smaller reporting company, the company can present only the two most recent fiscal years of audited financial statements in its Annual Report on Form 10-K[93]. - The company has elected to use an extended transition period for complying with new or revised accounting standards, delaying adoption until it is no longer classified as an emerging growth company[93]. - The financial statements of the company may not be comparable to those of companies that comply with new accounting pronouncements as of public company effective dates[93]. - The company is not required to provide quantitative and qualitative disclosures about market risk due to its status as a smaller reporting company[94]. Funding and Financial Resources - The company has the right to draw down 20.0millionunderaLoanAgreementwithSiliconValleyBank,withpotentialadditionalfundsavailableuponmeetingcertainmilestones[79][80].InterestincomefortheninemonthsendedSeptember30,2024,was20.0 million under a Loan Agreement with Silicon Valley Bank, with potential additional funds available upon meeting certain milestones[79][80]. - Interest income for the nine months ended September 30, 2024, was 3.9 million, down from 5.6millionin2023,representingadecreaseof5.6 million in 2023, representing a decrease of 1.7 million or 30%[76].