Tenaya Therapeutics(TNYA) - 2023 Q3 - Quarterly Report

Financial Performance - Net loss for Q3 2023 was $29.1 million, compared to a net loss of $30.7 million in Q3 2022, reflecting a decrease of $1.6 million[95]. - The net loss for the nine months ended September 30, 2023, was $94.1 million, compared to a net loss of $90.1 million in 2022, reflecting a 4% increase in losses[100]. - Cash used in operating activities was $80.1 million for the nine months ended September 30, 2023, slightly improved from $81.7 million in 2022[109]. - The company had cash, cash equivalents, and investments in marketable securities totaling $128.1 million as of September 30, 2023, with an accumulated deficit of $373.3 million[101]. - The company expects ongoing increases in expenses and operating losses due to continued product development and regulatory approval efforts[104]. Research and Development - Research and development expenses for Q3 2023 were $23.1 million, a decrease of 3% from $23.8 million in Q3 2022[86]. - Research and development expenses increased to $75.2 million for the nine months ended September 30, 2023, up from $68.8 million in 2022, representing a 9% increase[97]. - The company expects research and development expenses to remain flat for the remainder of 2023[90]. - TN-201, a gene therapy for hypertrophic cardiomyopathy, began dosing patients in a Phase 1b trial in October 2023, with initial data expected in 2024[78]. - TN-401, a gene therapy for arrhythmogenic right ventricular cardiomyopathy, received FDA clearance for clinical testing in October 2023[80]. - TN-301, a small molecule for heart failure with preserved ejection fraction, showed positive Phase 1 trial results, indicating robust HDAC6 inhibition[82]. - The company has initiated two non-interventional studies to support the development of TN-201, focusing on MYBPC3-associated cardiomyopathy[79]. - The Genetic Medicines Manufacturing Center is strategically located near research labs to support clinical studies and AAV-based gene therapies[85]. Expenses - General and administrative expenses increased to $7.8 million in Q3 2023, up 4% from $7.5 million in Q3 2022, primarily due to higher stock-based compensation[92]. - General and administrative expenses rose to $24.6 million in 2023, compared to $22.3 million in 2022, marking a 10% increase primarily due to higher stock-based compensation[98]. Income and Financing - Interest income rose significantly by 198% to $1.8 million in Q3 2023, up from $596,000 in Q3 2022, driven by higher interest rates on investments[86]. - Interest income surged to $5.6 million in 2023, a 509% increase from $917,000 in 2022, driven by higher interest rates on investments[99]. - The company raised $3.7 million from financing activities in 2023, primarily from at-the-market sales[113]. - The company has not generated any revenue since inception and relies on equity securities for funding operations[101]. Regulatory and Reporting Status - The company qualifies as a smaller reporting company under Rule 12b-2 and is not required to provide certain disclosures[122]. - As a smaller reporting company, the company may present only the two most recent fiscal years of audited financial statements in its Annual Report on Form 10-K[121]. - The company has reduced disclosure obligations regarding executive compensation due to its status as a smaller reporting company[121].