Day One Biopharmaceuticals Files 2023 Annual Report (10-K)

TL;DR

<b>Day One Biopharmaceuticals filed its 2023 10-K annual report, detailing its financial performance and business operations.</b>

AI Summary

Day One Biopharmaceuticals, Inc. (DAWN) filed a Annual Report (10-K) with the SEC on February 26, 2024. Filed its 2023 10-K report on February 26, 2024. The company's fiscal year ends on December 31. Incorporated in Delaware. Primary SIC code is Pharmaceutical Preparations [2834]. Business and mailing address is 2000 Sierra Point Parkway, Suite 501, Brisbane, CA 94005.

Why It Matters

For investors and stakeholders tracking Day One Biopharmaceuticals, Inc., this filing contains several important signals. This 10-K filing provides a comprehensive overview of Day One Biopharmaceuticals' financial health, operational activities, and strategic direction for the fiscal year 2023. Investors and stakeholders can use this report to assess the company's performance, identify potential risks, and make informed investment decisions.

Risk Assessment

Risk Level: medium — Day One Biopharmaceuticals, Inc. shows moderate risk based on this filing. The company operates in the pharmaceutical industry, which is subject to significant regulatory oversight, lengthy development cycles, and high R&D costs, posing inherent risks to financial performance and market success.

Analyst Insight

Review the detailed financial statements and risk factors in the 10-K to understand the company's current financial position and future outlook.

Key Numbers

• 2023-12-31 — Fiscal Year End (Period of Report)
• 2024-02-26 — Filing Date (Date Filed)
• 2834 — SIC Code (Standard Industrial Classification)
• 001-40431 — SEC File Number (SEC Filing Details)

Key Players & Entities

• Day One Biopharmaceuticals, Inc. (company) — Filer
• 2000 Sierra Point Parkway, Suite 501 (location) — Business Address
• Brisbane, CA (location) — Business Address
• 650 484-0899 (phone_number) — Business Phone
• Day One Biopharmaceuticals Holding Co LLC (company) — Former Company Name
• Sprint Bioscience (company) — Agreement related to R&D expense
• Merck (company) — License Agreement related to R&D expense

FAQ

Risk Factors

• Regulatory Risks [high — regulatory]: The pharmaceutical industry is subject to extensive regulation by governmental authorities, which can impact product development, manufacturing, marketing, and sales.
• Research and Development Costs [high — financial]: Significant investment in research and development is required, with no guarantee of successful product commercialization.
• Competition [medium — market]: The company faces intense competition from other pharmaceutical and biotechnology companies.
• Reliance on Key Personnel [medium — operational]: The success of the company may depend on the continued service of key scientific and management personnel.

Key Dates

• 2023-12-31: Fiscal Year End — End of the reporting period for the 10-K.
• 2024-02-26: 10-K Filing Date — Date the annual report was officially filed with the SEC.

Glossary

10-K

An annual report required by the U.S. Securities and Exchange Commission (SEC), which gives a comprehensive summary of a company's financial performance. (Provides detailed financial and operational information about the company for the fiscal year.)

SIC Code

Standard Industrial Classification code used to classify industries. (Helps categorize the company's primary business activity within the broader economy.)

Key Financial Figures

• $0.0001 — ch registered Common Stock, par value $0.0001 per share DAWN Nasdaq Global Select
• $10 billion — saw more than 40 transactions exceeding $10 billion in upfront deal value, including the ac

Filing Documents

• dawn-20231231.htm (10-K) — 3370KB
• dawn-ex21_1.htm (EX-21.1) — 2KB
• dawn-ex23_1.htm (EX-23.1) — 3KB
• dawn-ex23_2.htm (EX-23.2) — 6KB
• dawn-ex31_1.htm (EX-31.1) — 10KB
• dawn-ex31_2.htm (EX-31.2) — 10KB
• dawn-ex32_1.htm (EX-32.1) — 9KB
• dawn-ex97_1.htm (EX-97.1) — 81KB
• img12668759_0.jpg (GRAPHIC) — 114KB
• img12668759_1.jpg (GRAPHIC) — 115KB
• img12668759_2.jpg (GRAPHIC) — 111KB
• img12668759_3.jpg (GRAPHIC) — 40KB
• img12668759_4.jpg (GRAPHIC) — 192KB
• img12668759_5.jpg (GRAPHIC) — 108KB
• img12668759_6.jpg (GRAPHIC) — 62KB
• img12668759_7.jpg (GRAPHIC) — 156KB
• img12668759_8.jpg (GRAPHIC) — 72KB
• img12668759_9.jpg (GRAPHIC) — 110KB
• img12668759_10.jpg (GRAPHIC) — 98KB
• img12668759_11.jpg (GRAPHIC) — 90KB
• img12668759_12.jpg (GRAPHIC) — 51KB
• img12668759_13.jpg (GRAPHIC) — 133KB
• img12668759_14.jpg (GRAPHIC) — 76KB
• img12668759_15.jpg (GRAPHIC) — 92KB
• img12668759_16.jpg (GRAPHIC) — 114KB
• 0000950170-24-020212.txt (&nbsp;) — 15988KB
• dawn-20231231.xsd (EX-101.SCH) — 1552KB
• dawn-20231231_htm.xml (XML) — 1980KB

Business

Business 1 Item 1A.

Risk Factors

Risk Factors 42 Item 1B. Unresolved Staff Comments 111 Item 1C. Cybersecurity 111 Item 2.

Properties

Properties 114 Item 3.

Legal Proceedings

Legal Proceedings 114 Item 4. Mine Safety Disclosures 114 PART II Item 5. Market for Registrant's Common Equity, Related Stockholder Matters and Issuer Purchases of Equity Securities 115 Item 6. Reserved 116 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 117 Item 7A.

Quantitative and Qualitative Disclosures About Market Risk

Quantitative and Qualitative Disclosures About Market Risk 128 Item 8. Consolidated Financial Statements and Supplementary Data 128 Item 9. Changes in and Disagreements With Accountants on Accounting and Financial Disclosure 128 Item 9A.

Controls and Procedures

Controls and Procedures 128 Item 9B. Other Information 129 Item 9C. Disclosure Regarding Foreign Jurisdictions that Prevent Inspections 130 PART III Item 10. Directors, Executive Officers and Corporate Governance 131 Item 11.

Executive Compensation

Executive Compensation 131 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 131 Item 13. Certain Relationships and Related Transactions, and Director Independence 131 Item 14. Principal Accounting Fees and Services 131 PART IV Item 15. Exhibits, Financial Statement Schedules 132 Item 16. Form 10-K Summary 134 i PART I It em 1. Business. Overview Day One was founded to address a critical unmet need: the dire lack of therapeutic development in pediatric cancer. Our name was inspired by the "The Day One Talk" that physicians have with patients and their families about an initial cancer diagnosis and treatment plan. We aim to re-envision cancer drug development and redefine what's possible for all people living with cancer—regardless of age—starting from Day One. We are a clinical-stage biopharmaceutical company dedicated to developing and commercializing targeted therapies for people of all ages with life threatening diseases. We focus our initial clinical development efforts on pediatric patients living with cancer, a vulnerable population that has been underserved in the recent revolution in targeted therapeutics and immuno-oncology. Our lead product candidate, tovorafenib, is an oral, brain-penetrant, highly selective type II rapidly accelerated fibrosarcoma, or RAF, kinase inhibitor. Tovorafenib has been studied in over 450 patients and has been shown to be generally well-tolerated as a monotherapy. Tovorafenib has demonstrated encouraging anti-tumor activity in pediatric and adult populations with specific genetic alterations that result in the over-activation of the mitogen-activated protein kinase, or MAPK, pathway leading to uncontrolled cell growth. Tovorafenib was granted breakthrough therapy designation by the U.S. Food and Drug Administration, or the FDA, in August 2020 for the treatment of relapsed or refractory pediatric low-grade glioma, or pLGG, based on initial results from a Phase 1 trial

View Full Filing

View this 10-K filing on SEC EDGAR