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, 2022 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) (State or other jurisdic ...

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, 2022 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) (State or other jurisdi ...

| --- | --- | --- | --- | --- | |-------------------------------------|-------|-------|-------|-------| | | | | | | | in the Fight Against Heart Disease | | | | | | | | | | | | Corporate Overview | | | | | | March 2022 | | | | | | | | | | | Disclaimer 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 management's beliefs and assumptions and ...

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, 2021 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 (Stat ...

| --- | --- | --- | --- | --- | |-------------------------------------|-------|-------|-------|-------| | | | | | | | in the Fight Against Heart Disease | | | | | | | | | | | | Corporate Overview | | | | | | November 2021 | | | | | | | | | | | Disclaimer 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 management's beliefs and assumptions ...

PART I—FINANCIAL INFORMATION [Financial Statements](index=5&type=section&id=Item%201.%20Financial%20Statements) The company's unaudited financials show a significant asset increase to $331.8 million post-IPO, alongside a growing net loss of $46.6 million for the nine months ended September 30, 2021 [Condensed Balance Sheets](index=5&type=section&id=Condensed%20Balance%20Sheets) Total assets grew to $331.8 million and stockholders' equity turned positive to $303.7 million by September 30, 2021, driven by IPO proceeds and preferred stock conversion Condensed Balance Sheet Data (in thousands) | | September 30, 2021 (Unaudited) | December 31, 2020 | | :--- | :--- | :--- | | **Total current assets** | $284,822 | $129,964 | | **Total assets** | $331,794 | $148,161 | | **Total current liabilities** | $13,692 | $5,041 | | **Total liabilities** | $28,095 | $8,722 | | **Total stockholders' equity (deficit)** | $303,699 | $(81,315) | [Condensed Statements of Operations and Comprehensive Loss](index=6&type=section&id=Condensed%20Statements%20of%20Operations%20and%20Comprehensive%20Loss) Net losses increased to $18.3 million for Q3 2021 and $46.6 million for the first nine months, driven by higher R&D and G&A expenses Operating Results (in thousands) | | Three Months Ended Sep 30, | Nine Months Ended Sep 30, | | :--- | :--- | :--- | | | **2021** | **2020** | **2021** | **2020** | | **Research and development** | $12,944 | $8,480 | $33,440 | $22,735 | | **General and administrative** | $5,356 | $1,972 | $13,202 | $5,855 | | **Total operating expenses** | $18,300 | $10,452 | $46,642 | $28,590 | | **Loss from operations** | $(18,300) | $(10,452) | $(46,642) | $(28,590) | | **Net loss** | $(18,262) | $(10,295) | $(46,570) | $(28,077) | | **Net loss per share** | $(0.68) | $(10.29) | $(4.75) | $(29.65) | [Condensed Statements of Convertible Preferred Stock and Stockholders' Equity (Deficit)](index=7&type=section&id=Condensed%20Statements%20of%20Convertible%20Preferred%20Stock%20and%20Stockholders'%20Equity%20(Deficit)) The company's equity structure was transformed by the IPO, which converted all preferred stock and added substantial paid-in capital - Upon completion of the IPO, all **26,102,278 shares of convertible preferred stock were converted into common stock**[23](index=23&type=chunk) - The company issued **13,800,000 shares of common stock** in its IPO, resulting in a significant increase in additional paid-in capital[23](index=23&type=chunk) [Condensed Statements of Cash Flows](index=11&type=section&id=Condensed%20Statements%20of%20Cash%20Flows) Net cash used in operations and investing was offset by $209.0 million in financing activities, primarily from the IPO and Series C stock issuance Cash Flow Summary (in thousands) | | Nine Months Ended September 30, | | :--- | :--- | :--- | | | **2021** | **2020** | | **Net cash used in operating activities** | $(44,465) | $(25,046) | | **Net cash (used in) provided by investing activities** | $(175,984) | $1,167 | | **Net cash provided by financing activities** | $208,991 | $61,344 | | **Net change in cash, cash equivalents and restricted cash** | $(11,458) | $37,465 | | **Cash, cash equivalents and restricted cash at end of period** | $117,624 | $61,736 | [Notes to Unaudited Condensed Financial Statements](index=12&type=section&id=Notes%20to%20Unaudited%20Condensed%20Financial%20Statements) The notes detail the company's business, the $188.5 million net proceeds from its August 2021 IPO, and management's assertion of sufficient liquidity for the next year - The company is a preclinical stage biotechnology company focused on therapies for heart disease, advancing candidates from gene therapy, cellular regeneration, and precision medicine platforms[33](index=33&type=chunk) - On August 3, 2021, the company completed its IPO, issuing 13.8 million shares of common stock and receiving **net proceeds of $188.5 million**[35](index=35&type=chunk) - Management believes that its **cash, cash equivalents, and marketable securities of $280.5 million** as of September 30, 2021, are sufficient to fund operations for at least the next twelve months[36](index=36&type=chunk)[37](index=37&type=chunk) [Management's Discussion and Analysis of Financial Condition and Results of Operations](index=23&type=section&id=Item%202.%20Management's%20Discussion%20and%20Analysis%20of%20Financial%20Condition%20and%20Results%20of%20Operations) Management discusses its preclinical programs, increased operating expenses, and strengthened financial position following the $188.5 million IPO - The company is a preclinical biotechnology firm focused on curative therapies for heart disease with a pipeline including gene therapies and small molecules[101](index=101&type=chunk) - Key pipeline milestones for 2022 include submitting an IND or CTA for gene therapy candidate **TN-201** and an IND for small molecule inhibitor **TYA-11631**[103](index=103&type=chunk)[104](index=104&type=chunk) - The company completed its IPO on August 3, 2021, raising **net proceeds of $188.5 million**[105](index=105&type=chunk) [Results of Operations](index=25&type=section&id=Results%20of%20Operations) Net losses widened significantly in the three and nine months ended September 30, 2021, due to increased R&D and G&A spending Comparison of Operating Results (in thousands) | | Three Months Ended Sep 30, | Nine Months Ended Sep 30, | | :--- | :--- | :--- | | | **2021** | **2020** | **2021** | **2020** | | **Research and development** | $12,944 | $8,480 | $33,440 | $22,735 | | **General and administrative** | $5,356 | $1,972 | $13,202 | $5,855 | | **Net loss** | $(18,262) | $(10,295) | $(46,570) | $(28,077) | - The increase in R&D expenses was driven by higher facility and laboratory costs (**+$1.4M in Q3, +$5.0M in 9M**), personnel-related costs (**+$1.9M in Q3, +$3.9M in 9M**), and external research costs (**+$1.2M in Q3, +$1.8M in 9M**)[118](index=118&type=chunk)[119](index=119&type=chunk)[125](index=125&type=chunk)[130](index=130&type=chunk) - General and administrative expenses rose due to increased personnel costs, professional services for the IPO, and higher facility costs[120](index=120&type=chunk)[125](index=125&type=chunk) [Liquidity and Capital Resources](index=27&type=section&id=Liquidity%20and%20Capital%20Resources) The company holds $280.5 million in cash and securities post-IPO, sufficient for the next twelve months, but will require substantial future funding - As of September 30, 2021, the company had **cash, cash equivalents, and investments in marketable securities of $280.5 million**[129](index=129&type=chunk) - Management believes **existing cash will be sufficient to fund operations** and capital expenditure needs for at least the next twelve months[132](index=132&type=chunk) - The company will require **substantial additional funding** to complete the development and commercialization of its product candidates[133](index=133&type=chunk) [Quantitative and Qualitative Disclosures About Market Risk](index=30&type=section&id=Item%203.%20Quantitative%20and%20Qualitative%20Disclosures%20About%20Market%20Risk) As a smaller reporting company, this section is not applicable - As a smaller reporting company, Tenaya Therapeutics is **not required to provide** quantitative and qualitative disclosures about market risk[151](index=151&type=chunk) [Controls and Procedures](index=30&type=section&id=Item%204.%20Controls%20and%20Procedures) Management concluded that disclosure controls and procedures were effective as of September 30, 2021, with no material changes to internal controls - The CEO and CFO concluded that as of September 30, 2021, the company's **disclosure controls and procedures were effective**[152](index=152&type=chunk) - There were **no changes in internal control over financial reporting** during the quarter ended September 30, 2021, that have materially affected, or are reasonably likely to materially affect, internal controls[153](index=153&type=chunk) PART II—OTHER INFORMATION [Legal Proceedings](index=31&type=section&id=Item%201.%20Legal%20Proceedings) The company is not currently party to any material legal proceedings - As of the filing date, the company is **not involved in any legal proceedings** that are likely to have a material adverse effect on its business[155](index=155&type=chunk) [Risk Factors](index=31&type=section&id=Item%201A.%20Risk%20Factors) The company faces significant risks related to its early stage of development, history of losses, need for capital, and uncertainties in drug development and regulation - The company is in the **early stages of development** with a limited operating history, no products approved for sale, and has incurred significant net losses since inception[157](index=157&type=chunk)[158](index=158&type=chunk)[161](index=161&type=chunk) - **Substantial additional capital will be required** to finance operations, and failure to raise it could force delays or elimination of research programs[157](index=157&type=chunk)[168](index=168&type=chunk) - The development of novel gene therapy product candidates is subject to a **rigorous, complex, and uncertain regulatory landscape**, with no guarantee of approval[157](index=157&type=chunk)[192](index=192&type=chunk) - The company faces risks related to **intellectual property**, including the ability to obtain and enforce patents and operate without infringing on the rights of third parties[157](index=157&type=chunk)[333](index=333&type=chunk)[347](index=347&type=chunk) [Unregistered Sales of Equity Securities and Use of Proceeds](index=93&type=section&id=Item%202.%20Unregistered%20Sales%20of%20Equity%20Securities%20and%20Use%20of%20Proceeds) The company details pre-IPO stock option grants and confirms the use of its $188.5 million in net IPO proceeds remains consistent with its registration statement - From July 1 to July 30, 2021, the company granted stock options to employees to purchase an aggregate of **446,998 shares of common stock** at an exercise price of $10.56 per share[467](index=467&type=chunk) - The company's IPO on August 3, 2021, generated **net proceeds of approximately $188.5 million** after deducting underwriting discounts, commissions, and offering expenses[469](index=469&type=chunk) - There has been **no material change in the planned use of proceeds** from the IPO as described in the Form S-1 registration statement[469](index=469&type=chunk) [Defaults Upon Senior Securities](index=94&type=section&id=Item%203.%20Defaults%20Upon%20Senior%20Securities) This section is not applicable as the company reports no defaults [Mine Safety Disclosures](index=94&type=section&id=Item%204.%20Mine%20Safety%20Disclosures) This section is not applicable [Other Information](index=94&type=section&id=Item%205.%20Other%20Information) The company reports no other information for this period [Exhibits](index=95&type=section&id=Item%206.%20Exhibits) This section lists all exhibits filed with the quarterly report

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, 2021 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 ...