Sutro Biopharma, Inc. Files 2023 Annual Report on Form 10-K

TL;DR

<b>Sutro Biopharma, Inc. has filed its annual 10-K report for the fiscal year ending December 31, 2023.</b>

AI Summary

SUTRO BIOPHARMA, INC. (STRO) filed a Annual Report (10-K) with the SEC on March 25, 2024. Sutro Biopharma, Inc. filed its 2023 Form 10-K on March 25, 2024. The filing covers the fiscal year ending December 31, 2023. The company's principal executive offices are located at 111 Oyster Point Blvd., South San Francisco, CA. Sutro Biopharma operates in the Biological Products sector. The filing references various agreements including those with BMS, Merck, Vaxcyte, and Tasly.

Why It Matters

For investors and stakeholders tracking SUTRO BIOPHARMA, INC., this filing contains several important signals. This 10-K filing provides a comprehensive overview of Sutro Biopharma's financial performance, business operations, and risk factors for the fiscal year 2023, crucial for investors to assess the company's current standing and future prospects. The detailed information within the 10-K, including financial statements and disclosures on agreements, is essential for understanding the company's strategic partnerships and their impact on its product development and commercialization efforts.

Risk Assessment

Risk Level: medium — SUTRO BIOPHARMA, INC. shows moderate risk based on this filing. The company operates in the highly competitive and regulated biotechnology industry, facing risks related to clinical trial success, regulatory approvals, and market adoption of its products.

Analyst Insight

Investors should review the detailed risk factors and financial statements in the 10-K to understand the potential challenges and opportunities facing Sutro Biopharma in the coming fiscal year.

Key Numbers

• 20231231 — Fiscal Year End (CONFORMED PERIOD OF REPORT)
• 20240325 — Filing Date (FILED AS OF DATE)
• 2836 — Standard Industrial Classification (BIOLOGICAL PRODUCTS (NO DIAGNOSTIC SUBSTANCES))

Key Players & Entities

• SUTRO BIOPHARMA, INC. (company) — FILER
• 20231231 (date) — CONFORMED PERIOD OF REPORT
• 20240325 (date) — FILED AS OF DATE
• 111 OYSTER POINT BLVD. (address) — BUSINESS ADDRESS STREET 1
• SOUTH SAN FRANCISCO (location) — BUSINESS ADDRESS CITY
• CA (location) — BUSINESS ADDRESS STATE
• 650-392-8412 (phone) — BUSINESS PHONE
• BMS (company) — agreement reference

FAQ

Risk Factors

• Competition [high — market]: The company faces intense competition from other biotechnology and pharmaceutical companies, which could adversely affect its ability to achieve market penetration and profitability.
• Regulatory Approval [high — regulatory]: The development and commercialization of the company's product candidates are subject to stringent regulatory review and approval processes by agencies like the FDA, which can be lengthy and uncertain.
• Funding Requirements [medium — financial]: The company will require substantial additional funding to finance its ongoing research and development activities, clinical trials, and potential commercialization efforts.
• Manufacturing and Supply Chain [medium — operational]: Reliance on third-party manufacturers and potential disruptions in the supply chain could impact the timely production and delivery of its product candidates.

Key Dates

• 2023-12-31: Fiscal Year End — End of the reporting period for the 10-K.
• 2024-03-25: 10-K Filing Date — Date the annual report was officially filed with the SEC.

Key Financial Figures

• $0.001 — nge on which registered Common stock, $0.001 par value STRO The Nasdaq Stock Mar
• $4.65 — arter), based upon the closing price of $4.65 of the Registrant's common stock as rep
• $854 million — received an aggregate of approximately $854 million in payments from all of our collaborati
• $54 million — borations, which includes approximately $54 million in investments in our stock. We intend

Filing Documents

• stro-20231231.htm (10-K) — 4163KB
• stro-ex4_2.htm (EX-4.2) — 32KB
• stro-ex10_14.htm (EX-10.14) — 62KB
• stro-ex10_24.htm (EX-10.24) — 107KB
• stro-ex10_30.htm (EX-10.30) — 63KB
• stro-ex10_34.htm (EX-10.34) — 332KB
• stro-ex10_43.htm (EX-10.43) — 432KB
• stro-ex23_1.htm (EX-23.1) — 12KB
• stro-ex31_1.htm (EX-31.1) — 14KB
• stro-ex31_2.htm (EX-31.2) — 15KB
• stro-ex32_1.htm (EX-32.1) — 7KB
• stro-ex32_2.htm (EX-32.2) — 7KB
• stro-ex97_1.htm (EX-97.1) — 80KB
• img141552205_0.jpg (GRAPHIC) — 30KB
• img141552205_1.jpg (GRAPHIC) — 19KB
• img141552205_2.jpg (GRAPHIC) — 22KB
• img141552205_3.jpg (GRAPHIC) — 144KB
• img141552205_4.jpg (GRAPHIC) — 221KB
• img163211892_0.jpg (GRAPHIC) — 131KB
• img216776110_0.jpg (GRAPHIC) — 131KB
• 0000950170-24-035949.txt (&nbsp;) — 17494KB
• stro-20231231.xsd (EX-101.SCH) — 1951KB
• stro-20231231_htm.xml (XML) — 2749KB

Business

Business 6 ITEM 1A.

Risk Factors

Risk Factors 43 ITEM 1B. Unresolved Staff Comments 98 ITEM 1C. Cybersecurity 98 ITEM 2.

Properties

Properties 100 ITEM 3.

Legal Proceedings

Legal Proceedings 100 ITEM 4. Mine Safety Disclosures 100 PART II 101 ITEM 5. Market for Registrant's Common Equity, Related Stockholder Matters, and Issuer Purchases of Equity Securities 101 ITEM 6. [Reserved] 103 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 104 ITEM 7A.

Quantitative and Qualitative Disclosures About Market Risk

Quantitative and Qualitative Disclosures About Market Risk 121 ITEM 8.

Financial Statements and Supplementary Data

Financial Statements and Supplementary Data 122 ITEM 9. Changes in and Disagreements with Accountants on Accounting and Financial Disclosure 160 ITEM 9A.

Controls and Procedures

Controls and Procedures 160 ITEM 9B. Other Information 161 ITEM 9C. Disclosure Regarding Foreign Jurisdictions that Prevent Inspections 161 PART III 162 ITEM 10. Directors, Executive Officers of the Registrant and Corporate Governance 162 ITEM 11.

Executive Compensation

Executive Compensation 162 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 162 ITEM 13. Certain Relationships and Related Transactions, and Director Independence 162 ITEM 14. Principal Accounting Fees and Services 162 PART IV 163 ITEM 15. Exhibits and Financial Statement Schedules 163 ITEM 16. Form 10-K Summary 167

Signatures

Signatures 168 2

Forward-Looking Statements

Forward-Looking Statements This Annual Report on Form 10-K, or Annual Report, contains forward-looking statements within the meaning of Section 21E of the Securities Exchange Act of 1934, as amended, or the Exchange Act, and section 27A of the Securities Act of 1933, as amended, or the Securities Act. All statements contained in this Annual Report other than statements of historical fact, including statements regarding our future results of operations and financial position, the use and adequacy of our existing cash to achieve our business goals, business strategy, market size for our product candidates, potential future milestone and royalty payments, the value of our holdings of Vaxcyte common stock, potential growth opportunities, nonclinical and clinical development activities, efficacy and safety profile of our product candidates, our ability to maintain and recognize the benefits of certain designations received by product candidates, our ability to successfully leverage Fast Track designation, the timing and results of nonclinical studies and clinical trials, collaboration with third parties, the impact of health pandemics, regional geopolitical conflicts, changes in interest rates, inflation, potential uncertainty with respect to the debt ceiling and potential government shutdown related thereto, on our operations, and the receipt and timing of potential regulatory designations, approvals and commercialization of product candidates, are forward-looking statements. The words "believe," "may," "will," "potentially," "estimate," "continue," "anticipate," "predict," "target," "intend," "could," "would," "should," "project," "plan," "expect," and similar expressions that convey uncertainty of future events or outcomes are intended to identify forward-looking statements, although not all forward-looking statements contain these identifying words. These forward-looking statements are subject to a number of risks, uncertainties and assumptions, including those d

Business

Item 1. Business Overview We are a clinical-stage oncology company developing site-specific and novel-format antibody drug conjugates, or ADCs, enabled by our proprietary integrated cell-free protein synthesis platform, XpressCF , and our site-specific conjugation platform, XpressCF+ . We aim to design and develop therapeutics using the most relevant and potent modalities, including ADCs, bispecific ADCs, immunostimulatory ADCs, or iADCs, dual conjugate ADCs, or ADC 2 s, and cytokine derivatives. Our molecules are directed primarily against clinically validated targets where the current standard of care is suboptimal. We believe that our platform allows us to accelerate the discovery and development of potential first-in-class and/or best-in-class molecules by enabling the rapid and systematic evaluation of protein structure-activity relationships to create optimized homogeneous product candidates. Our mission is to transform the lives of patients by creating medicines with improved therapeutic profiles for areas of unmet need. Our most advanced product candidate is STRO-002, or luveltamab tazevibulin, or luvelta, an ADC directed against folate receptor-alpha, or FolR, for patients with FolR-expressing cancers, including ovarian cancer. In 2019, we began enrolling patients in a Phase 1 trial of luvelta that focused on ovarian and endometrial cancers. The Phase 1 trial assessing safety, tolerability and preliminary efficacy of luvelta to treat platinum resistant ovarian cancer has been completed. In January 2024, we reported near-final results from this Phase 1 trial, in which luvelta exhibited a manageable safety profile together with promising preliminary efficacy data in the tested patient population, as discussed in detail below. We also presented data from Phase 1b trials assessing safety, tolerability and preliminary efficacy for the treatment of ovarian cancer with luvelta in combination with bevacizumab and for treatment of endometrial cancer. In August

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View this 10-K filing on SEC EDGAR