IDEAYA Biosciences, Inc. Files 2023 Annual Report on Form 10-K

TL;DR

<b>IDEAYA Biosciences, Inc. has filed its 2023 10-K report detailing its fiscal year performance and corporate activities.</b>

AI Summary

IDEAYA Biosciences, Inc. (IDYA) filed a Annual Report (10-K) with the SEC on February 20, 2024. IDEAYA Biosciences, Inc. filed its 2023 Annual Report on Form 10-K on February 20, 2024. The filing covers the fiscal year ending December 31, 2023. Key events and agreements mentioned include the June 2023 Sales Agreement with Jefferies LLC and At-The-Market offerings. The company's business address is 7000 Shoreline Court, Suite 350, South San Francisco, CA 94080. The filing references various financial instruments and programs, including common stock, warrants, and incentive award plans.

Why It Matters

For investors and stakeholders tracking IDEAYA Biosciences, Inc., this filing contains several important signals. This 10-K filing provides a comprehensive overview of IDEAYA Biosciences' financial health, operational activities, and strategic initiatives for the fiscal year 2023, crucial for investors to assess the company's progress and future outlook. The detailed information within the report, including financial statements and risk factors, is essential for stakeholders to understand the company's current standing and potential challenges in the competitive biotechnology landscape.

Risk Assessment

Risk Level: medium — IDEAYA Biosciences, Inc. shows moderate risk based on this filing. The company operates in the highly regulated pharmaceutical industry, facing risks related to drug development, clinical trials, regulatory approvals, and market competition, as evidenced by the numerous program mentions and financial instruments detailed in the filing.

Analyst Insight

Investors should review the detailed financial statements and risk factors in the 10-K to understand IDEAYA Biosciences' current financial position and the potential challenges in its drug development pipeline.

Key Numbers

• 2023-12-31 — Fiscal Year End (Reported period)
• 2024-02-20 — Filing Date (Date of submission)
• 001-38915 — SEC File Number (Associated SEC file number)
• 650-443-6209 — Business Phone (Contact number)

Key Players & Entities

• IDEAYA Biosciences, Inc. (company) — Filer name
• Jefferies LLC (company) — Mentioned in relation to a Sales Agreement
• GlaxoSmithKline (company) — Mentioned in relation to a Collaboration Agreement
• South San Francisco, CA (location) — Business address
• 2023-12-31 (date) — Fiscal year end
• 2024-02-20 (date) — Filing date

FAQ

Risk Factors

• Regulatory Risks [high — regulatory]: The company is subject to extensive government regulation, including the FDA, which can impact product development, approval, and marketing.
• Market Competition [high — market]: The biotechnology market is highly competitive, with many companies developing similar therapies, which could affect market share and pricing.
• Funding and Liquidity [medium — financial]: The company's ability to fund its operations and research and development activities depends on its access to capital and its ability to generate revenue.
• Clinical Trial Risks [high — operational]: The success of drug development is uncertain, and clinical trials may fail to demonstrate efficacy or safety, leading to delays or discontinuation of programs.

Key Dates

• 2023-12-31: Fiscal Year End — Marks the end of the reporting period for the 10-K.
• 2024-02-20: Filing Date — Date the 10-K was officially submitted to the SEC.

Key Financial Figures

• $0.0001 — nge on which registered Common Stock, $0.0001 par value per share IDYA Nasdaq Glo
• $23.50 — lobal Select Market on June 30, 2023 of $23.50 per share, was $ 1.3 billion. Shares of
• $7.0 million — ned, and in October 2023 we received, a $7.0 million milestone payment upon acceptance of th
• $10.0 million — gible to receive a potential additional $10.0 million milestone payment upon initiation of Ph
• $3.0 million — y, or MSI. In October 2023, we earned a $3.0 million milestone from GSK in connection with I

Filing Documents

• idya-20231231.htm (10-K) — 3376KB
• idya-ex4_3.htm (EX-4.3) — 45KB
• idya-ex10_13.htm (EX-10.13) — 29KB
• idya-ex10_23.htm (EX-10.23) — 549KB
• idya-ex10_25.htm (EX-10.25) — 718KB
• idya-ex23_1.htm (EX-23.1) — 3KB
• idya-ex31_1.htm (EX-31.1) — 16KB
• idya-ex31_2.htm (EX-31.2) — 16KB
• idya-ex32_1.htm (EX-32.1) — 14KB
• idya-ex97.htm (EX-97) — 45KB
• img41158376_0.jpg (GRAPHIC) — 582KB
• img268055577_0.jpg (GRAPHIC) — 174KB
• img268055577_1.jpg (GRAPHIC) — 79KB
• 0000950170-24-017093.txt (&nbsp;) — 13606KB
• idya-20231231.xsd (EX-101.SCH) — 1263KB
• idya-20231231_htm.xml (XML) — 1496KB

Business

Business 1 Item 1A.

Risk Factors

Risk Factors 44 Item 1B. Unresolved Staff Comments 102 Item 1C. Cybersecurity 102 Item 2.

Properties

Properties 103 Item 3.

Legal Proceedings

Legal Proceedings 103 Item 4. Mine Safety Disclosures 103 PART II Item 5. Market for Registrant's Common Equity, Related Stockholder Matters and Issuer Purchase of Equity Securities 104 Item 6. Reserved 104 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 105 Item 7A.

Quantitative and Qualitative Disclosures About Market Risk

Quantitative and Qualitative Disclosures About Market Risk 120 Item 8.

Financial Statements and Supplementary Data

Financial Statements and Supplementary Data 120 Item 9. Changes in and Disagreements With Accountants on Accounting and Financial Disclosures 120 Item 9A.

Controls and Procedures

Controls and Procedures 121 Item 9B. Other Information 121 Item 9C. Disclosure Regarding Foreign Jurisdictions that Prevent Inspections 121 PART III Item 10. Directors, Executive Officers and Corporate Governance 122 Item 11.

Executive Compensation

Executive Compensation 122 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 122 Item 13. Certain Relationships and Related Transactions, and Director Independence 122 Item 14. Principal Accounting Fees and Services 122 PART IV Item 15. Exhibits, Financial Statement Schedules 123 Item 16. Form 10-K Summary 127 i NOTE REGARDING FORWARD-LOOKING STATEMENTS This Annual Report on Form 10-K contains forward-looking statements. We intend such forward-looking statements to be covered by the safe harbor provisions for forward-looking statements contained in Section 27A of the Securities Act of 1933 and Section 21E of the Securities Exchange Act of 1934. All statements other than statements of historical facts contained in this Form 10-K, including statements regarding our future results of operations and financial position, business strategy, prospective products, product approvals, research and development costs, timing and likelihood of success, plans and objectives of management for future operations and future results of anticipated products, are forward-looking statements. These statements involve known and unknown risks, uncertainties and other important factors that may cause our actual results, performance or achievements to be materially different from any future results, performance or achievements expressed or implied by the forward-looking statements. In some cases, you can identify forward-looking statements by terms such as "may," "will," "should," "expect," "plan," "anticipate," "could," "intend," "target," "project," "contemplate," "believe," "estimate," "predict," "potential" or "continue" or the negative of these terms or other similar expressions. The forward-looking statements in this Annual Report on Form 10-K are only predictions. We have based these forward-looking statements largely on our current expectations and projections about future events and financial trends that we believe may affect our b

Busi ness

Item 1. Busi ness. Company Overview We are a precision medicine oncology company committed to the discovery and development of targeted therapeutics for patient populations selected using molecular diagnostics. Our clinical pipeline includes four potential first-in-class clinical-stage product candidates – darovasertib (PKC), IDE397 (MAT2A), IDE161 (PARG) and GSK101 (Pol Theta Helicase). We own or control all commercial rights of the three most-advanced of these product candidates: darovasertib, IDE397, and IDE161. We are also advancing our Werner Helicase program for which we have selected a development candidate in collaboration with GlaxoSmithKline, or GSK and, subject to investigational new drug-, or IND-, enabling studies, are targeting an IND in 2024. We also have multiple earlier-stage preclinical programs. We have established selective, value-accretive collaborations with leading pharmaceutical companies to support our clinical development activities. Our most advanced clinical program is evaluating darovasertib, or IDE196 which we in-licensed from Novartis, a small molecule protein kinase C, or PKC, inhibitor, in uveal melanoma, or UM. We have initiated a potential registration-enabling Phase 2/3 clinical trial, designated as IDE196-002, to evaluate darovasertib in combination with crizotinib, Pfizer's investigational cMET inhibitor, in patients having metastatic UM, or MUM, with human leukocyte antigen-, or HLA-A*02:01 negative, or HLA-A2(-), serotype, as part of a second Clinical Trial Collaboration and Supply Agreement, or Second Pfizer agreement, with Pfizer. We have achieved double-digit patient enrollment and have opened multiple clinical sites, including international sites, where we are recruiting patients for enrollment in this planned global Phase 2/3 clinical trial. We reported positive interim clinical data in April 2023 from our Phase 2 clinical trial evaluating darovasertib and crizotinib in MUM. We also reported updated darovasertib cli

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