Tenaya Therapeutics, Inc. Files 2023 Annual Report on Form 10-K

TL;DR

<b>Tenaya Therapeutics, Inc. has filed its annual report detailing its 2023 fiscal year performance and financial standing.</b>

AI Summary

Tenaya Therapeutics, Inc. (TNYA) filed a Annual Report (10-K) with the SEC on March 18, 2024. Tenaya Therapeutics, Inc. filed its 2023 Form 10-K on March 18, 2024. The company's fiscal year ends on December 31st. Tenaya Therapeutics is in the business of Biological Products (No Diagnostic Substances). The company is incorporated in Delaware. Its principal business address is 171 Oyster Point Blvd., Suite 500, South San Francisco, CA 94080.

Why It Matters

For investors and stakeholders tracking Tenaya Therapeutics, Inc., this filing contains several important signals. This filing provides a comprehensive overview of Tenaya's financial health, operational activities, and strategic direction for the past fiscal year, crucial for investors to assess the company's progress and future prospects. As a biotechnology company, understanding the details within this 10-K is vital for stakeholders to evaluate its research and development pipeline, potential market opportunities, and any associated risks.

Risk Assessment

Risk Level: medium — Tenaya Therapeutics, Inc. shows moderate risk based on this filing. The company is in the early stages of development for its product candidates, which carries inherent risks related to clinical trial success, regulatory approval, and market adoption, as is typical for biotechnology firms.

Analyst Insight

Investors should review the detailed risk factors and financial statements in the 10-K to assess the company's ability to fund its operations and achieve its development milestones.

Key Numbers

• 2023-12-31 — Fiscal Year End (Conformed period of report)
• 2024-03-18 — Filing Date (Filed as of date)
• 10-K — Form Type (Conformed submission type)
• 69 — Document Count (Public document count)

Key Players & Entities

• Tenaya Therapeutics, Inc. (company) — Filer name
• 2023 (date) — Fiscal year
• 2024-03-18 (date) — Filing date
• 171 Oyster Point Blvd., Suite 500 (address) — Business address
• South San Francisco, CA 94080 (address) — Business address
• DE (state) — State of incorporation
• 2836 (sic_code) — Standard Industrial Classification
• 001-40656 (sec_file_number) — SEC file number

FAQ

Risk Factors

• Ability to Fund Future Operations [high — financial]: The company has a history of net losses and negative cash flows from operations, and may require additional financing to fund its ongoing operations and development plans.
• Regulatory Approval Process [high — regulatory]: The development and commercialization of the company's product candidates are subject to extensive and rigorous regulatory review and approval processes by governmental authorities.
• Market Acceptance of Product Candidates [medium — market]: The success of the company's product candidates depends on their acceptance by patients, physicians, and the healthcare industry, which is uncertain.
• Reliance on Key Personnel [medium — operational]: The company's success depends significantly on its ability to attract and retain highly qualified scientific and management personnel.
• Uncertainty of Future Revenue [high — financial]: The company has not generated significant revenue to date and does not expect to generate significant revenue for several years, if ever.

Key Dates

• 2023-12-31: Fiscal Year End — Marks the end of the reporting period for the 2023 Form 10-K.

Key Financial Figures

• $0.0001 — ange on which registered Common Stock $0.0001 par value per share TNYA Nasdaq Glo

Filing Documents

• tnya-20231231.htm (10-K) — 2365KB
• tnya-ex10_10.htm (EX-10.10) — 50KB
• tnya-ex23_1.htm (EX-23.1) — 3KB
• tnya-ex31_1.htm (EX-31.1) — 18KB
• tnya-ex31_2.htm (EX-31.2) — 18KB
• tnya-ex32_1.htm (EX-32.1) — 19KB
• tnya-ex97.htm (EX-97) — 47KB
• img252036137_0.jpg (GRAPHIC) — 125KB
• 0000950170-24-032828.txt (&nbsp;) — 9100KB
• tnya-20231231.xsd (EX-101.SCH) — 1329KB
• tnya-20231231_htm.xml (XML) — 1315KB

Business

Business 3 Item 1A.

Risk Factors

Risk Factors 36 Item 1B. Unresolved Staff Comments 87 Item 1C. Cybersecurity 87 Item 2.

Properties

Properties 88 Item 3.

Legal Proceedings

Legal Proceedings 88 Item 4. Mine Safety Disclosures 88 PART II Item 5. Market for Registrant's Common Equity, Related Stockholder Matters and Issuer Purchases of Equity Securities 89 Item 6. Reserved 89 Item 7.

Management's Discussion and Analysis of Financial Condition and Results of Operations

Management's Discussion and Analysis of Financial Condition and Results of Operations 90 Item 7A.

Quantitative and Qualitative Disclosures About Market Risk

Quantitative and Qualitative Disclosures About Market Risk 98 Item 8.

Financial Statements and Supplementary Data

Financial Statements and Supplementary Data 99 Item 9. Changes in and Disagreements with Accountants on Accounting and Financial Disclosure 119 Item 9A.

Controls and Procedures

Controls and Procedures 119 Item 9B. Other Information 120 Item 9C. Disclosure Regarding Foreign Jurisdictions that Prevent Inspections 120 PART III Item 10. Directors, Executive Officers and Corporate Governance 121 Item 11.

Executive Compensation

Executive Compensation 121 Item 12.

Security Ownership of Certain Beneficial Owners and Management and Related Stockholder Matters

Security Ownership of Certain Beneficial Owners and Management and Related Stockholder Matters 121 Item 13. Certain Relationships and Related Transactions, and Director Independence 121 Item 14. Principal Accounting Fees and Services 121 PART IV Item 15. Exhibits, Financial Statement Schedules 122 Item 16 Form 10-K Summary 122

Signatures

Signatures 125 i SPECIAL NOTE REGARDING FORWARD-LOOKING STATEMENTS This Annual Report on Form 10-K, or Annual Report, contains forward-looking statements within the meaning of Section 27A of the Securities Act of 1933, as amended (Securities Act) and Section 21E of the Securities Exchange Act of 1934, as amended (Exchange Act). All statements other than statements of historical facts contained in this Annual Report, including statements regarding our future results of operations and financial position, business strategy, development plans, planned preclinical studies and clinical trials, future results of clinical trials, expected research and development costs, regulatory strategy, timing and likelihood of success, as well as plans and objectives of management for future operations, are forward-looking statements. In some cases, investors can identify forward-looking statements by terms such as "may," "will," "should," "would," "expect," "plan," "anticipate," "could," "intend," "target," "project," "contemplate," "believe," "estimate," "predict," "potential," "vision," or "continue" or the negative of these terms or other similar expressions. These forward-looking statements include, but are not limited to, statements about: our vision to change the treatment paradigm for heart disease; the ability of our ongoing preclinical studies and ongoing or planned clinical trials to demonstrate safety and efficacy of our product candidates, and other positive results; the timing, dosing, patient enrollment and populations, progress, and results of preclinical studies and ongoing or planned clinical trials for our current product candidates and other product candidates we may develop; the timing, scope and likelihood of regulatory filings and approvals, including timing of investigational new drugs (INDs), clinical trial applications (CTAs), U.S. Food and Drug Administration (FDA) approvals, and final regulatory approval of our current product candidates and

. Business

Item 1 . Business. Overview We are a clinical-stage biotechnology company committed to a bold mission: to discover, develop and deliver potentially curative therapies that address the underlying drivers of heart disease. Heart disease is the leading cause of death in the world, representing an estimated 32% of all global fatalities. In the United States (U.S.), one in every five deaths is attributable to heart disease, and an estimated 40,000 infants are born each year with congenital heart conditions. While there is a clear need for improved treatments, the rate of cardiovascular drug product approvals has declined in recent years and few of the approved treatments address the underlying cause of such diseases. Our collective understanding of the links between heart disease and genetic factors is increasing exponentially, creating new opportunities for the advancement of novel disease-modifying therapeutics that target the underlying cause of disease. Roughly one-third to one-half of all heart diseases are linked to genetic risks, regardless of major racial and ethnic backgrounds, and there are over 250 known genetically defined disorders where the primary source of morbidity and mortality involves the heart. Leveraging this improved understanding of the genetic causes of heart disease, as well as an increased recognition that precision medicine initiatives may accelerate the advancement of scientific breakthroughs, our vision is to change the treatment paradigm for heart disease and in doing so, improve and extend the lives of patients. Our goal is to build a leading fully-integrated biopharmaceutical company focused on precision medicines for heart disease. We believe that our drug development efforts benefit from a deep understanding of the underlying causes of disease for specific subpopulations of patients within both rare and prevalent forms of heart disease. We have invested in differentiated capabilities that enable target identification, target val