Tenaya Therapeutics(TNYA)

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Tenaya Therapeutics(TNYA) - 2024 Q1 - Quarterly Report
2024-05-14 20:15
Commission File Number: 001-40656 UNITED STATES SECURITIES AND EXCHANGE COMMISSION WASHINGTON, DC 20549 FORM 10-Q (Mark One) ☒ QUARTERLY REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the quarterly period ended March 31, 2024 OR ☐ TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the transition period from ________ to _________ TENAYA THERAPEUTICS, INC. (Exact name of registrant as specified in its charter) Delaware 81-3789973 (St ...
Tenaya Therapeutics(TNYA) - 2024 Q1 - Quarterly Results
2024-05-14 20:09
Exhibit 99.1 Tenaya Therapeutics Reports First Quarter 2024 Financial Results and Provides Business Update Initial Data from Ongoing MyPEAK TM-1 Phase 1b of TN-201 Expected in Second Half of 2024 Clinical Sites Activated for RIDGE TM-1 Phase 1b Clinical Trial of TN-401 Announced Cost Containment Measures in Alignment with Focus on Generating Data from Clinical-Stage Gene Therapy Programs Raised $47 Million Net Proceeds in First Quarter Financing; Current Cash Runway into Second Half of 2025 SOUTH SAN FRANCI ...
Tenaya Therapeutics(TNYA) - 2023 Q4 - Annual Report
2024-03-18 20:10
Financial Performance - The company reported total operating expenses of $131.2 million for the year ended December 31, 2023, an increase of 4% from $125.6 million in 2022[483]. - The company incurred a net loss of $124.1 million for the year ended December 31, 2023, compared to a net loss of $123.7 million in 2022, reflecting a marginal increase of $419, or 0%[491]. - Net cash used in operating activities for the year ended December 31, 2023, was $102.1 million, compared to $104.4 million in 2022[501][502]. - Net cash provided by investing activities for the year ended December 31, 2023, was $48.7 million, down from $83.7 million in 2022[503][504]. - Net cash provided by financing activities for the year ended December 31, 2023, was $4.0 million, significantly lower than $77.8 million in 2022[505]. - The company expects to incur operating losses in the foreseeable future, with operating expenses anticipated to remain relatively flat over the next twelve months[497]. Research and Development - Research and development expenses were $98.0 million in 2023, up 4% from $94.5 million in 2022, primarily due to an increase of $8.9 million in personnel-related costs[485]. - The company initiated dosing in the MyPeak-1 Phase 1b clinical trial for TN-201 in October 2023, with initial data expected in the second half of 2024[473]. - The FDA cleared the IND application for TN-401 in October 2023, with patient dosing planned to begin in the second half of 2024[476]. - TN-301 showed positive results in a Phase 1 clinical trial, demonstrating good tolerability and pharmacokinetic properties supportive of once-daily dosing[479]. - The company plans to advance its lead gene therapy product candidates, TN-201 and TN-401, and expand clinical trials into late-stage development[498]. Funding and Capital - The company completed a follow-on offering on February 12, 2024, raising approximately $46.5 million from the sale of 8,888,890 shares at $4.50 per share[493]. - The company raised approximately $76.9 million from the purchase of an additional 2,816,409 shares of common stock after deducting underwriting discounts and commissions[495]. - As of December 31, 2023, the company has approximately $71.0 million available for issuance under its "at-the-market" equity offering[496]. Company Status and Classification - The company has not generated any revenue to date and has an accumulated deficit of $403.3 million as of December 31, 2023[492]. - The company is classified as an emerging growth company and a smaller reporting company, with annual revenue below $100 million and market value of stock held by non-affiliates less than $700 million[517][519]. Lease Obligations - The company has future minimum lease payments of approximately $5.1 million and $10.9 million remaining on its South San Francisco and Union City leases, respectively[506]. Off-Balance Sheet Arrangements - The company has not engaged in any off-balance sheet arrangements since inception[509]. Interest Income - Interest income increased significantly by 261% to $7.1 million in 2023, up from $2.0 million in 2022, primarily due to higher interest rates on investments[490].
Tenaya Therapeutics(TNYA) - 2023 Q4 - Annual Results
2024-03-18 20:08
Exhibit 99.1 Tenaya Therapeutics Reports Fourth Quarter and Full Year 2023 Financial Results and Provides Business Update Initial Data from Ongoing MyPeak™-1 Phase 1b of TN-201 for MYBPC3-associated HCM Expected in Second Half of 2024 On Track to Dose First Patient in RIDGE™-1Phase 1b Clinical Trial of TN-401 for PKP2-associated ARVC in Second Half 2024 $47 Million Net Proceeds from Recent Financing Extends Cash Runway into Second Half of 2025 SOUTH SAN FRANCISCO, Calif., March 18, 2024 -- Tenaya Therapeuti ...
Tenaya Therapeutics(TNYA) - 2023 Q3 - Quarterly Report
2023-11-08 21:21
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].
Tenaya Therapeutics(TNYA) - 2023 Q2 - Quarterly Report
2023-08-09 20:26
UNITED STATES SECURITIES AND EXCHANGE COMMISSION WASHINGTON, DC 20549 FORM 10-Q (Mark One) ☒ QUARTERLY REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the quarterly period ended June 30, 2023 OR ☐ TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the transition period from ________ to _________ Commission File Number: 001-40656 TENAYA THERAPEUTICS, INC. (Exact name of registrant as specified in its charter) Delaware 81-3789973 (Sta ...
Tenaya Therapeutics(TNYA) - 2023 Q1 - Quarterly Report
2023-05-10 20:35
UNITED STATES SECURITIES AND EXCHANGE COMMISSION WASHINGTON, DC 20549 FORM 10-Q (Mark One) ☒ QUARTERLY REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the quarterly period ended March 31, 2023 OR ☐ TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the transition period from ________ to _________ Commission File Number: 001-40656 TENAYA THERAPEUTICS, INC. (Exact name of registrant as specified in its charter) Delaware 81-3789973 (St ...
Tenaya Therapeutics (TNYA) Investor Presentation - Slideshow
2023-03-10 13:09
13 MyPeak-1 Phase 1b Clinical Study TN-201 for MYBPC3 HCM 70%nonobstructive 30%obstructive Disease severity higher with pathogenic sarcomeric gene mutations such as MYBPC3, but no treatments address underlying genetic cause1 Characteristics Symptoms Disease burden • Thickening of left ventricle (hypertrophy) due to excessive contraction • May be characterized as "obstructive" or "nonobstructive" based on location of thickening • Shortness of breath, fainting, chest pain, fatigue, palpitations and arrhythmia ...
Tenaya Therapeutics(TNYA) - 2022 Q4 - Annual Report
2023-03-08 21:34
UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 FORM 10-K (Mark One) ☒ ANNUAL REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the fiscal year ended December 31, 2022 OR ☐ TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 Commission File Number 001-40656 TENAYA THERAPEUTICS, INC. (Exact name of Registrant as specified in its Charter) (State or other jurisdiction of incorporation or organization) 171 Oyster Point ...
Tenaya Therapeutics (TNYA) Investor Presentation - Slideshow
2022-10-06 17:13
| --- | --- | --- | --- | --- | |-------------------------------------|-------|-------|-------|-------| | | | | | | | in the Fight Against Heart Disease | | | | | | | | | | | | Corporate Presentation | | | | | | September 2022 | | | | | | | | | | | | | | | | | Forward-looking Statement This presentation contains forward-looking statements within the meaning of Section 27A of the Securities Act of 1933, as amended and Section 21E of the Securities Exchange Act of 1934, as amended, that are based on our manag ...