Grundläggande statistik
| CIK | 1845337 |
SEC Filings
SEC Filings (Chronological Order)
| May 4, 2026 |
15-12G UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 FORM 15 CERTIFICATION AND NOTICE OF TERMINATION OF REGISTRATION UNDER SECTION 12(g) OF THE SECURITIES EXCHANGE ACT OF 1934 OR SUSPENSION OF DUTY TO FILE REPORTS UNDER SECTIONS 13 AND 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934. Commission File Number 001-40431 DAY ONE BIOPHARMACEUTICALS, INC. (Exact name of registrant |
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| April 23, 2026 |
AMENDED AND RESTATED CERTIFICATE OF INCORPORATION OF DAY ONE BIOPHARMACEUTICALS, INC. EX-3.1 Exhibit 3.1 AMENDED AND RESTATED CERTIFICATE OF INCORPORATION OF DAY ONE BIOPHARMACEUTICALS, INC. 1. The name of the Corporation is: Day One Biopharmaceuticals, Inc. 2. The address of the Corporation’s registered office in the State of Delaware is 1209 Orange Street, in the City of Wilmington, County of New Castle, 19801. The name of its registered agent at such address is: The Corporation |
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| April 23, 2026 |
As filed with the Securities and Exchange Commission on April 23, 2026 S-8 POS As filed with the Securities and Exchange Commission on April 23, 2026 Registration No. |
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| April 23, 2026 |
UNITED STATES SECURITIES AND EXCHANGE COMMISSION WASHINGTON, D.C. 20549 FORM 8-K CURRENT REPORT Pursuant to Section 13 or 15(d) of the Securities Exchange Act of 1934 Date of Report (Date of earliest event reported): April 22, 2026 DAY ONE BIOPHARMACEUTICALS, INC. (Exact name of registrant as specified in its charter) Delaware 001-40431 83-2415215 (State or other jurisdiction of incorporation) (Co |
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| April 23, 2026 |
As filed with the Securities and Exchange Commission on April 23, 2026 S-8 POS As filed with the Securities and Exchange Commission on April 23, 2026 Registration No. |
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| April 23, 2026 |
SC 14D9/A UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 SCHEDULE 14D-9 (Rule 14d-101) Solicitation/Recommendation Statement under Section 14(d)(4) of the Securities Exchange Act of 1934 (Amendment No. 3) Day One Biopharmaceuticals, Inc. (Name of Subject Company) Day One Biopharmaceuticals, Inc. (Name of Person(s) Filing Statement) Common Stock, par value $0.0001 per share |
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| April 23, 2026 |
As filed with the Securities and Exchange Commission on April 23, 2026 S-8 POS As filed with the Securities and Exchange Commission on April 23, 2026 Registration No. |
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| April 23, 2026 |
As filed with the Securities and Exchange Commission on April 23, 2026 POSASR As filed with the Securities and Exchange Commission on April 23, 2026 Registration No. |
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| April 23, 2026 |
As filed with the Securities and Exchange Commission on April 23, 2026 S-8 POS As filed with the Securities and Exchange Commission on April 23, 2026 Registration No. |
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| April 23, 2026 |
As filed with the Securities and Exchange Commission on April 23, 2026 POSASR As filed with the Securities and Exchange Commission on April 23, 2026 Registration No. |
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| April 23, 2026 |
As filed with the Securities and Exchange Commission on April 23, 2026 S-8 POS As filed with the Securities and Exchange Commission on April 23, 2026 Registration No. |
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| April 23, 2026 |
As filed with the Securities and Exchange Commission on April 23, 2026 S-8 POS As filed with the Securities and Exchange Commission on April 23, 2026 Registration No. |
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| April 23, 2026 |
EX-3.2 Exhibit 3.2 DAY ONE BIOPHARMACEUTICALS, INC. (a Delaware corporation) AMENDED AND RESTATED BYLAWS As Amended and Restated on April 23, 2026 ARTICLE I Offices Section 1.1 Registered Office. The corporation shall maintain a registered office and registered agent in the State of Delaware. The registered office and/or registered agent of the corporation may be changed from time to time by actio |
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| April 17, 2026 |
UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 FORM 10-K/A Amendment No. 1 l UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 FORM 10-K/A Amendment No. 1 (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, 2025 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 001-4 |
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| April 14, 2026 |
SC 14D9/A UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 SCHEDULE 14D-9 (Rule 14d-101) Solicitation/Recommendation Statement under Section 14(d)(4) of the Securities Exchange Act of 1934 (Amendment No. 2) Day One Biopharmaceuticals, Inc. (Name of Subject Company) Day One Biopharmaceuticals, Inc. (Name of Person(s) Filing Statement) Common Stock, par value $0.0001 per share |
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| April 8, 2026 |
SC 14D9/A UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 SCHEDULE 14D-9 (Rule 14d-101) Solicitation/Recommendation Statement under Section 14(d)(4) of the Securities Exchange Act of 1934 (Amendment No. 1) Day One Biopharmaceuticals, Inc. (Name of Subject Company) Day One Biopharmaceuticals, Inc. (Name of Person(s) Filing Statement) Common Stock, par value $0.0001 per share |
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| March 26, 2026 |
SC 14D9 Table of Contents UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D. |
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| March 9, 2026 |
SC TO-C UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 SCHEDULE TO Tender Offer Statement under Section 14(d)(1) or 13(e)(1) of the Securities Exchange Act of 1934 DAY ONE BIOPHARMACEUTICALS, INC. (Name of Subject Company (Issuer)) SERVIER DETROIT INC., (Names of Filing Persons (Offeror)) a direct, wholly owned subsidiary of SERVIER PHARMACEUTICALS LLC, (Names of Filing Pe |
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| March 9, 2026 |
UNITED STATES SECURITIES AND EXCHANGE COMMISSION WASHINGTON, D.C. 20549 FORM 8-K/A (AMENDMENT NO. 1) CURRENT REPORT Pursuant to Section 13 or 15(d) of the Securities Exchange Act of 1934 Date of Report (Date of earliest event reported): January 06, 2026 DAY ONE BIOPHARMACEUTICALS, INC. (Exact name of Registrant as Specified in Its Charter) Delaware 001-40431 83-2415215 (State or Other Jurisdiction |
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| March 9, 2026 |
EX-99.1 Exhibit 99.1 Global corporate channels LinkedIn Threads EXCOM Communication - LinkedIn Olivier Laureau Pascal Lemaire Charlotte Marmousez – Tartar US channels LinkedIn Important Information for Investors and Security Holders The tender offer for the issued and outstanding shares of common stock of Day One Biopharmaceuticals, Inc. (the “Company”) referred to in this communication has not ye |
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| March 9, 2026 |
UNAUDITED PRO FORMA CONDENSED COMBINED FINANCIAL INFORMATION UNAUDITED PRO FORMA CONDENSED COMBINED FINANCIAL INFORMATION On January 6, 2026, or the Closing Date, Day One Biopharmaceuticals, Inc. |
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| March 6, 2026 |
EX-2.1 Exhibit 2.1 Execution Version AGREEMENT AND PLAN OF MERGER DATED AS OF MARCH 6, 2026, AMONG SERVIER PHARMACEUTICALS LLC, SERVIER DETROIT INC., DAY ONE BIOPHARMACEUTICALS, INC. AND, SOLELY FOR THE PURPOSES OF SECTION 10.12, SERVIER S.A.S. Table of Contents Page ARTICLE I DEFINITIONS 2 SECTION 1.01 Definitions 2 SECTION 1.02 Interpretation and Rules of Construction 11 ARTICLE II THE OFFER 12 |
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| March 6, 2026 |
SC14D9C UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 SCHEDULE 14D-9 (Rule 14d-101) Solicitation/Recommendation Statement under Section 14(d)(4) of the Securities Exchange Act of 1934 Day One Biopharmaceuticals, Inc. (Name of Subject Company) Day One Biopharmaceuticals, Inc. (Name of Person(s) Filing Statement) Common Stock, par value $0.001 per share (Title of Class of S |
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| March 6, 2026 |
EX-99.1 Exhibit 99.1 Servier and Day One Biopharmaceuticals announce acquisition to expand Servier’s rare oncology portfolio • Acquisition positions Servier as a leader in pediatric low-grade glioma and expands its pipeline with programs targeting adult and pediatric cancers with high unmet needs • Transaction represents total equity value of approximately $2.5 billion Suresnes, France and Brisban |
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| March 6, 2026 |
EX-99.3 Exhibit 99.3 Dear Day One [Customer/Vendor/Supplier/Partner/Collaborator], This morning we announced that we have entered into a definitive agreement to be acquired by Servier, an international pharmaceutical group with a growing oncology portfolio. You can read the announcement here. [link] Servier is enthusiastic about the planned acquisition, and looks forward to integrating OJEMDA® and |
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| March 6, 2026 |
EX-99.1 Exhibit 99.1 Servier and Day One Biopharmaceuticals announce acquisition to expand Servier’s rare oncology portfolio • Acquisition positions Servier as a leader in pediatric low-grade glioma and expands its pipeline with programs targeting adult and pediatric cancers with high unmet needs • Transaction represents total equity value of approximately $2.5 billion Suresnes, France and Brisban |
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| March 6, 2026 |
EX-99.4 Exhibit 99.4 Dear colleagues, This morning, we announced that we have entered into a definitive agreement to be acquired by Servier, an international pharmaceutical group with a growing oncology portfolio. You can read the announcement here [link]. We believe that joining forces with Servier will allow us to further our mission to deliver life-changing medicines for people of all ages, and |
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| March 6, 2026 |
SC TO-C UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 SCHEDULE TO Tender Offer Statement under Section 14(d)(1) or 13(e)(1) of the Securities Exchange Act of 1934 DAY ONE BIOPHARMACEUTICALS, INC. (Name of Subject Company (Issuer)) SERVIER DETROIT INC., (Names of Filing Persons (Offeror)) a direct, wholly owned subsidiary of SERVIER PHARMACEUTICALS LLC, (Names of Filing Pe |
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| March 6, 2026 |
EX-99.5 Exhibit 99.5 Social post Formal announcement: Today we’ve announced a definitive agreement to be acquired by Servier. Servier shares our deep commitment to advancing innovation in cancer along with our patient-focused methodology to address the most pressing areas of unmet need. Please refer to today’s press release for important information about this transaction. [link] Jeremy Quote: “Se |
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| March 6, 2026 |
UNITED STATES SECURITIES AND EXCHANGE COMMISSION WASHINGTON, D.C. 20549 FORM 8-K CURRENT REPORT Pursuant to Section 13 or 15(d) of the Securities Exchange Act of 1934 Date of Report (Date of earliest event reported): [ March 6, 2026 ] DAY ONE BIOPHARMACEUTICALS, INC. (Exact name of registrant as specified in its charter) Delaware 001-40431 83-2415215 (State or other jurisdiction of incorporation) |
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| March 6, 2026 |
EX-99.2 Exhibit 99.2 Employee FAQ ABOUT THE AGREEMENT Key Points: • Servier and Day One announced an agreement for the acquisition of Day One by Servier for $21.50 per share, or approximately $2.5 billion. • The acquisition represents an opportunity to expand the reach of Day One’s innovation and community impact, and strengthens Servier’s growing offerings in rare cancers, expanding its portfolio |
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| March 6, 2026 |
EX-99.1 Exhibit 99.1 Servier and Day One Biopharmaceuticals announce acquisition to expand Servier’s rare oncology portfolio • Acquisition positions Servier as a leader in pediatric low-grade glioma and expands its pipeline with programs targeting adult and pediatric cancers with high unmet needs • Transaction represents total equity value of approximately $2.5 billion Suresnes, France and Brisban |
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| March 2, 2026 |
EX-99.1 Exhibit 99.1 Day One Biopharmaceuticals Targeted therapies for people of all ages March 2026 Disclaimer This presentation and the accompanying oral commentary contain forward-looking statements that are based on our management’s beliefs and assumptions and on information currently available to our management. Forward-looking statements are inherently subject to risks and uncertainties, som |
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| March 2, 2026 |
UNITED STATES SECURITIES AND EXCHANGE COMMISSION WASHINGTON, D.C. 20549 FORM 8-K CURRENT REPORT Pursuant to Section 13 or 15(d) of the Securities Exchange Act of 1934 Date of Report (Date of earliest event reported): (March 2, 2026) DAY ONE BIOPHARMACEUTICALS, INC. (Exact name of registrant as specified in its charter) Delaware 001-40431 83-2415215 (State or other jurisdiction of incorporation) (C |
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| February 24, 2026 |
Targeted therapies for people of all ages February 2026 Day One Biopharmaceuticals Targeted therapies for people of all ages February 2026 Day One Biopharmaceuticals Disclaimer This presentation and the accompanying oral commentary contain forward-looking statements that are based on our management’s beliefs and assumptions and on information currently available to our management. |
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| February 24, 2026 |
Subsidiaries of Day One Biopharmaceuticals, Inc. Exhibit 21.1 Subsidiaries of Day One Biopharmaceuticals, Inc. Name of Subsidiary Jurisdiction Mersana Therapeutics, Inc. Delaware Mersana Securities Corp. Massachusetts |
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| February 24, 2026 |
Exhibit 99.1 Day One Reports Fourth Quarter and Full Year 2025 Financial Results and Reaffirms 2026 Outlook and Revenue Guidance OJEMDA™ 2025 momentum reflected by Q4 and full year net product revenues of $52.8 million and $155.4 million, respectively 2026 U.S. net product revenue projected at $225 - $250 million Expanded pipeline with January 2026 acquisition of Mersana Therapeutics; Emi-Le in Ph |
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| February 24, 2026 |
FEBRUARY 2026 Fourth Quarter & Full-Year 2025 Financial Results & Corporate Progress FEBRUARY 2026 Fourth Quarter & Full-Year 2025 Financial Results & Corporate Progress Forward Looking Statements This presentation and the accompanying oral commentary contain forward-looking statements that are based on our management’s beliefs and assumptions and on information currently available to our management. |
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| February 24, 2026 |
UNITED STATES SECURITIES AND EXCHANGE COMMISSION WASHINGTON, D.C. 20549 FORM 8-K CURRENT REPORT Pursuant to Section 13 or 15(d) of the Securities Exchange Act of 1934 Date of Report (Date of earliest event reported): February 24, 2026 DAY ONE BIOPHARMACEUTICALS, INC. (Exact name of registrant as specified in its charter) Delaware 001-40431 83-2415215 (State or other jurisdiction of incorporation) |
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| February 24, 2026 |
UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 FORM 10-K l 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, 2025 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 001-40431 DAY ONE BIOPH |
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| February 24, 2026 |
DAY ONE BIOPHARMACEUTICALS, INC. DIRECTOR EQUITY DEFERRAL PLAN Exhibit 10.6 DAY ONE BIOPHARMACEUTICALS, INC. DIRECTOR EQUITY DEFERRAL PLAN Day One Biopharmaceuticals, Inc. (the “Company”) hereby establishes the Day One Biopharmaceuticals Director Equity Deferral Plan (the “Plan”), effective on the Effective Date (as defined below). The purpose of the Plan is to attract and retain members of the Board by providing such persons with an opportunity to defer rece |
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| January 12, 2026 |
UNITED STATES SECURITIES AND EXCHANGE COMMISSION WASHINGTON, D.C. 20549 FORM 8-K CURRENT REPORT Pursuant to Section 13 or 15(d) of the Securities Exchange Act of 1934 Date of Report (Date of earliest event reported): (January 11, 2026) DAY ONE BIOPHARMACEUTICALS, INC. (Exact name of registrant as specified in its charter) Delaware 001-40431 83-2415215 (State or other jurisdiction of incorporation) |
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| January 12, 2026 |
EX-99.1 Exhibit 99.1 Day One Announces Preliminary 2025 OJEMDA™ Net Product Revenue And Provides 2026 Net Product Revenue Guidance Preliminary 2025 net product revenue of $155.4 million, representing 172% year-over-year growth; OJEMDA 2026 U.S. net product revenue projected to be $225—$250 million Company to present on corporate progress and priorities for 2026 during J.P. Morgan Healthcare Confer |
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| January 12, 2026 |
EX-99.3 Targeted therapies for people of all ages January 2026 Day One Biopharmaceuticals Exhibit 99.3 Disclaimer This presentation and the accompanying oral commentary contain forward-looking statements that are based on our management’s beliefs and assumptions and on information currently available to our management. Forward-looking statements are inherently subject to risks and uncertainties, s |
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| January 12, 2026 |
EX-99.2 Day One Biopharmaceuticals Targeted therapies for people of all ages January 2026 44th Annual J.P. Morgan Healthcare Conference Exhibit 99.2 Forward looking statements This presentation and the accompanying oral commentary contain forward-looking statements that are based on our management’s beliefs and assumptions and on information currently available to our management. Forward-looking s |
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| January 6, 2026 |
Exhibit 99.1 Day One Completes Acquisition of Mersana Therapeutics Acquisition expands Day One’s pipeline with clinical-stage antibody drug conjugate (ADC) emiltatug ledadotin (Emi-Le) targeting rare cancer adenoid cystic carcinoma (ACC) BRISBANE, Calif., JANUARY 6, 2026 – Day One Biopharmaceuticals, Inc. (Nasdaq: DAWN) (“Day One”), a biopharmaceutical company dedicated to developing and commercia |
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| January 6, 2026 |
UNITED STATES SECURITIES AND EXCHANGE COMMISSION WASHINGTON, D.C. 20549 FORM 8-K CURRENT REPORT Pursuant to Section 13 or 15(d) of the Securities Exchange Act of 1934 Date of Report (Date of earliest event reported): January 6, 2026 DAY ONE BIOPHARMACEUTICALS, INC. (Exact name of registrant as specified in its charter) Delaware 001-40431 83-2415215 (State or Other Jurisdiction of Incorporation) (C |
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| January 6, 2026 |
Targeted therapies for people of all ages January 2026 Day One Biopharmaceuticals Exhibit 99.2 Targeted therapies for people of all ages January 2026 Day One Biopharmaceuticals 2 Disclaimer This presentation and the accompanying oral commentary contain forward - looking statements that are based on our management’s bel iefs and assumptions and on information currently available to our management. Forward - looking statements are inherently subject to risks and uncertainties, so |
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| January 6, 2026 |
Contingent Value Rights Agreement Exhibit 10.1 Contingent Value Rights Agreement This Contingent Value Rights Agreement, dated as of January 6, 2026 (this “Agreement”), is entered into by and between Day One Biopharmaceuticals, Inc., a Delaware corporation (“Parent”), and Computershare Inc., a Delaware corporation (“Computershare”), and its affiliate, Computershare Trust Company, N.A., a federally chartered trust company (“Compute |
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| January 6, 2026 |
Exhibit (a)(5)(H) Day One Completes Acquisition of Mersana Therapeutics Acquisition expands Day One’s pipeline with clinical-stage antibody drug conjugate (ADC) emiltatug ledadotin (Emi-Le) targeting rare cancer adenoid cystic carcinoma (ACC) BRISBANE, Calif. |
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| January 6, 2026 |
UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 SCHEDULE TO Tender Offer Statement under Section 14(d)(1) or 13(e)(1) of the Securities Exchange Act of 1934 (Amendment No. 2) MERSANA THERAPEUTICS, INC. (Name of Subject Company (issuer)) EMERALD MERGER SUB, INC. (Offeror) a direct wholly owned subsidiary of DAY ONE BIOPHARMACEUTICALS, INC. (Parent of Offeror) (Names of Filin |
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| December 29, 2025 |
UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 SCHEDULE TO Tender Offer Statement under Section 14(d)(1) or 13(e)(1) of the Securities Exchange Act of 1934 (Amendment No. 1) Mersana Therapeutics, Inc. (Name of Subject Company (issuer)) Emerald Merger Sub, Inc. (Offeror) a direct wholly owned subsidiary of Day One Biopharmaceuticals, Inc. (Parent of Offeror) (Names of Filin |
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| December 5, 2025 |
TABLE OF CONTENTS Exhibit (a)(1)(A) Offer to Purchase All Outstanding Shares of Common Stock of MERSANA THERAPEUTICS, INC. |
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| December 5, 2025 |
Exhibit (a)(1)(D) Offer to Purchase All Outstanding Shares of Common Stock of MERSANA THERAPEUTICS, INC. |
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| December 5, 2025 |
MUTUAL CONFIDENTIALITY AGREEMENT Exhibit (d)(4) MUTUAL CONFIDENTIALITY AGREEMENT This Mutual Confidentiality Agreement (this “Agreement”) is effective as of March 12, 2025 (the “Effective Date”), between Mersana Therapeutics, Inc. |
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| December 5, 2025 |
Exhibit (a)(1)(B) LETTER OF TRANSMITTAL to Tender Shares of Common Stock of MERSANA THERAPEUTICS, INC. |
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| December 5, 2025 |
Exhibit (a)(1)(C) Offer to Purchase All Outstanding Shares of Common Stock of MERSANA THERAPEUTICS, INC. |
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| December 5, 2025 |
Table 1: Transaction Valuation Calculation of Filing Fee Tables Table 1: Transaction Valuation Transaction Valuation Fee Rate Amount of Filing Fee Fees to be Paid 1 $ 141,456,981. |
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| December 5, 2025 |
UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 SCHEDULE TO Tender Offer Statement under Section 14(d)(1) or 13(e)(1) of the Securities Exchange Act of 1934 MERSANA THERAPEUTICS, INC. (Name of Subject Company (issuer)) EMERALD MERGER SUB, INC. (Offeror) a direct wholly owned subsidiary of DAY ONE BIOPHARMACEUTICALS, INC. (Parent of Offeror) (Names of Filing Persons (identif |
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| December 5, 2025 |
Exhibit (a)(1)(E) This announcement is neither an offer to purchase nor a solicitation of an offer to sell Shares (as defined below) and the provisions herein are subject in their entirety to the provisions of the Offer (as defined below). |
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| December 4, 2025 |
UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 SCHEDULE TO Tender Offer Statement under Section 14(d)(1) or 13(e)(1) of the Securities Exchange Act of 1934 Mersana Therapeutics, Inc. (Name of Subject Company (issuer)) Emerald Merger Sub, Inc. (Offeror) a wholly-owned subsidiary of Day One Biopharmaceuticals, Inc. (Parent of Offeror) (Names of Filing Persons (identifying st |
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| December 4, 2025 |
A First-in-Class Opportunity with Emi-Le, A Novel ADC Exhibit 99.1 A First-in-Class Opportunity with Emi-Le, A Novel ADC We at Day One continue to be excited about the potential opportunity that antibody-drug conjugates (ADCs) present for the development of new medicines for adults and children living with cancer. A number of ADCs are demonstrating activity as monotherapy and in combination with other cancer medicines, opening the possibility that ne |
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| November 24, 2025 |
EX-99.1 Exhibit 99.1 Day One Announces Three Year Follow-Up Data From OJEMDA™ (tovorafenib) Phase 2 FIREFLY-1 Trial at the 2025 Society for Neuro-Oncology (SNO) Annual Meeting Updated data expands clinically meaningful results available from FIREFLY-1 pivotal trial 77% of patients who entered the treatment-free observation period following OJEMDA treatment remained off therapy for at least 12 mont |
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| November 24, 2025 |
UNITED STATES SECURITIES AND EXCHANGE COMMISSION WASHINGTON, D.C. 20549 FORM 8-K CURRENT REPORT Pursuant to Section 13 or 15(d) of the Securities Exchange Act of 1934 Date of Report (Date of earliest event reported): (November 24, 2025) DAY ONE BIOPHARMACEUTICALS, INC. (Exact name of registrant as specified in its charter) Delaware 001-40431 83-2415215 (State or other jurisdiction of incorporation |
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| November 24, 2025 |
EX-99.2 Exhibit 99.2 Day One Biopharmaceuticals Targeted therapies for people of all ages November 2025 Disclaimer This presentation and the accompanying oral commentary contain forward-looking statements that are based on our management’s beliefs and assumptions and on information currently available to our management. Forward-looking statements are inherently subject to risks and uncertainties, |
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| November 14, 2025 |
Exhibit 99.1 P R E S E N T A T I O N Operator Hello, ladies and gentlemen, and welcome to the Conference Call and Live Webcast, Day One Biopharmaceuticals to Acquire Mersana Therapeutics. At this time, all participants are in a listen-only mode. Later, we will conduct a question-and-answer session. Please be advised that this conference call is being recorded. I would now like to turn the call ove |
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| November 14, 2025 |
UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 SCHEDULE TO Tender Offer Statement under Section 14(d)(1) or 13(e)(1) of the Securities Exchange Act of 1934 Mersana Therapeutics, Inc. (Name of Subject Company (issuer)) Emerald Merger Sub, Inc. (Offeror) a wholly-owned subsidiary of Day One Biopharmaceuticals, Inc. (Parent of Offeror) (Names of Filing Persons (identifying st |
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| November 13, 2025 |
Email from Parent to Target’s Employees Exhibit 99.2 Email from Parent to Target’s Employees November 13, 2025 Dear Mersana Team, Today marks an exciting new chapter for both of our organizations. While we remain two independent companies until the transaction closes, I want to share a few thoughts with you. First, I’d like to acknowledge the significance of this moment. Mersana has done exceptional work to bring Emi-Le and XMT-2056 to |
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| November 13, 2025 |
UNITED STATES SECURITIES AND EXCHANGE COMMISSION WASHINGTON, D.C. 20549 FORM 8-K CURRENT REPORT Pursuant to Section 13 or 15(d) of the Securities Exchange Act of 1934 Date of Report (Date of earliest event reported): (November 12, 2025) DAY ONE BIOPHARMACEUTICALS, INC. (Exact name of registrant as specified in its charter) Delaware 001-40431 83-2415215 (State or other jurisdiction of incorporation |
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| November 13, 2025 |
NOVEMBER 2025 Acquisition of Mersana Therapeutics Exhibit 99.2 NOVEMBER 2025 Acquisition of Mersana Therapeutics 2 Confidential Information. For internal use only. Day One’s Mission Inspired by the urgent needs of children, Day One creatively and intentionally develops new medicines for people of all ages with life - threatening diseases Forward Looking Statements 3 This communication contains forward - looking statements. Forward - looking state |
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| November 13, 2025 |
Day One Social Media Announcement Exhibit 99.1 Day One Social Media Announcement LinkedIn and X November 13, 2025 Day One to Acquire Mersana Therapeutics to Advance Mission to Bring New Medicines to People of All Ages with Life-Threatening Diseases Read more: [Here] Additional Information about the Transaction and Where to Find It The tender offer described in this communication (the Offer) has not yet commenced, and this communic |
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| November 13, 2025 |
UNITED STATES SECURITIES AND EXCHANGE COMMISSION WASHINGTON, D.C. 20549 FORM 8-K CURRENT REPORT Pursuant to Section 13 or 15(d) of the Securities Exchange Act of 1934 Date of Report (Date of earliest event reported): (November 12, 2025) DAY ONE BIOPHARMACEUTICALS, INC. (Exact name of registrant as specified in its charter) Delaware 001-40431 83-2415215 (State or other jurisdiction of incorporation |
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| November 13, 2025 |
Exhibit 99.3 Targeted therapies for people of all ages November 2025 Day One Biopharmaceuticals 2 Disclaimer This presentation and the accompanying oral commentary contain forward-looking statements that are based on our management’s beliefs and assumptions and on information currently available to our management. Forward-looking statements are inherently subject to risks and uncertainties, some o |
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| November 13, 2025 |
UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 SCHEDULE TO Tender Offer Statement under Section 14(d)(1) or 13(e)(1) of the Securities Exchange Act of 1934 Mersana Therapeutics, Inc. (Name of Subject Company (issuer)) Emerald Merger Sub, Inc. (Offeror) a wholly-owned subsidiary of Day One Biopharmaceuticals, Inc. (Parent of Offeror) (Names of Filing Persons (identifying st |
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| November 13, 2025 |
Exhibit 99.1 Day One to Acquire Mersana Therapeutics to Advance Mission to Bring New Medicines to People of All Ages with Life-Threatening Diseases Acquisition expands Day One’s portfolio with novel antibody-drug conjugate (ADC) emiltatug ledadotin (Emi-Le) Emi-Le has demonstrated early anti-tumor activity in an ongoing Phase 1 study for adenoid cystic carcinoma type-1 (ACC-1), a cancer with high |
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| November 4, 2025 |
Targeted therapies for people of all ages November 2025 Day One Biopharmaceuticals Targeted therapies for people of all ages November 2025 Day One Biopharmaceuticals Disclaimer This presentation and the accompanying oral commentary contain forward-looking statements that are based on our management’s beliefs and assumptions and on information currently available to our management. |
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| November 4, 2025 |
f UNITED STATES SECURITIES AND EXCHANGE COMMISSION WASHINGTON, D.C. 20549 FORM 10-Q f UNITED STATES SECURITIES AND EXCHANGE COMMISSION WASHINGTON, D.C. 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 September 30, 2025 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: 001-40431 DAY |
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| November 4, 2025 |
Day One Reports Third Quarter 2025 Financial Results and Corporate Progress Commercial execution delivers best quarter launch-to-date with growth across all dimensions of core business Raising OJEMDA full-year 2025 net product revenue guidance to $145 to $150 million Three-year FIREFLY-1 data to be released in oral presentation at Society for Neuro-Oncology on Nov. |
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| November 4, 2025 |
UNITED STATES SECURITIES AND EXCHANGE COMMISSION WASHINGTON, D.C. 20549 FORM 8-K CURRENT REPORT Pursuant to Section 13 or 15(d) of the Securities Exchange Act of 1934 Date of Report (Date of earliest event reported): November 04, 2025 DAY ONE BIOPHARMACEUTICALS, INC. (Exact name of registrant as specified in its charter) Delaware 001-40431 83-2415215 (State or other jurisdiction of incorporation) |
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| November 4, 2025 |
NOVEMBER 2025 Third Quarter 2025 Financial Results & Corporate Progress NOVEMBER 2025 Third Quarter 2025 Financial Results & Corporate Progress Forward Looking Statements This presentation and the accompanying oral commentary contain forward-looking statements that are based on our management’s beliefs and assumptions and on information currently available to our management. |
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| October 10, 2025 |
UNITED STATES SECURITIES AND EXCHANGE COMMISSION WASHINGTON, D.C. 20549 FORM 8-K CURRENT REPORT Pursuant to Section 13 or 15(d) of the Securities Exchange Act of 1934 Date of Report (Date of earliest event reported): (October 7, 2025) DAY ONE BIOPHARMACEUTICALS, INC. (Exact name of registrant as specified in its charter) Delaware 001-40431 83-2415215 (State or other jurisdiction of incorporation) |
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| August 5, 2025 |
Exhibit 99.1 Day One Reports Second Quarter 2025 Financial Results and Corporate Progress OJEMDATM (tovorafenib) net product revenue of $33.6 million in Q2 2025, a 10% quarter-over-quarter increase OJEMDA full-year 2025 net product revenue expected to be $140 to $150 million Ended the second quarter with $453.1 million in cash, cash equivalents and short-term investments Company to host conference |
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| August 5, 2025 |
Targeted therapies for people of all ages August 2025 Day One Biopharmaceuticals Targeted therapies for people of all ages August 2025 Day One Biopharmaceuticals Disclaimer This presentation and the accompanying oral commentary contain forward-looking statements that are based on our management’s beliefs and assumptions and on information currently available to our management. |
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| August 5, 2025 |
f UNITED STATES SECURITIES AND EXCHANGE COMMISSION WASHINGTON, D.C. 20549 FORM 10-Q f UNITED STATES SECURITIES AND EXCHANGE COMMISSION WASHINGTON, D.C. 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, 2025 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: 001-40431 DAY ONE |
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| August 5, 2025 |
AUGUST 2025 Second Quarter 2025 Financial Results & Corporate Progress AUGUST 2025 Second Quarter 2025 Financial Results & Corporate Progress Forward Looking Statements This presentation and the accompanying oral commentary contain forward-looking statements that are based on our management’s beliefs and assumptions and on information currently available to our management. |
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| August 5, 2025 |
UNITED STATES SECURITIES AND EXCHANGE COMMISSION WASHINGTON, D.C. 20549 FORM 8-K CURRENT REPORT Pursuant to Section 13 or 15(d) of the Securities Exchange Act of 1934 Date of Report (Date of earliest event reported): August 05, 2025 DAY ONE BIOPHARMACEUTICALS, INC. (Exact name of registrant as specified in its charter) Delaware 001-40431 83-2415215 (State or other jurisdiction of incorporation) (C |
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| June 3, 2025 |
UNITED STATES SECURITIES AND EXCHANGE COMMISSION WASHINGTON, D.C. 20549 FORM 8-K CURRENT REPORT Pursuant to Section 13 or 15(d) of the Securities Exchange Act of 1934 Date of Report (Date of earliest event reported): (June 2, 2025) DAY ONE BIOPHARMACEUTICALS, INC. (Exact name of registrant as specified in its charter) Delaware 001-40431 83-2415215 (State or other jurisdiction of incorporation) (Co |
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| May 6, 2025 |
UNITED STATES SECURITIES AND EXCHANGE COMMISSION WASHINGTON, D.C. 20549 FORM 8-K CURRENT REPORT Pursuant to Section 13 or 15(d) of the Securities Exchange Act of 1934 Date of Report (Date of earliest event reported): May 06, 2025 DAY ONE BIOPHARMACEUTICALS, INC. (Exact name of registrant as specified in its charter) Delaware 001-40431 83-2415215 (State or other jurisdiction of incorporation) (Comm |
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| May 6, 2025 |
MAY 2025 First Quarter 2025 Financial Results & Corporate Progress MAY 2025 First Quarter 2025 Financial Results & Corporate Progress Forward looking statements This presentation and the accompanying oral commentary contain forward-looking statements that are based on our management’s beliefs and assumptions and on information currently available to our management. |
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| May 6, 2025 |
f UNITED STATES SECURITIES AND EXCHANGE COMMISSION WASHINGTON, D.C. 20549 FORM 10-Q f UNITED STATES SECURITIES AND EXCHANGE COMMISSION WASHINGTON, D.C. 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, 2025 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: 001-40431 DAY ONE |
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| May 6, 2025 |
Exhibit 99.1 Day One Reports First Quarter 2025 Financial Results and Corporate Progress OJEMDATM (tovorafenib) prescriptions grew 16% in Q1 2025 compared to Q4 2024 Achieved Q1 2025 OJEMDATM (tovorafenib) net product revenue of $30.5 million Ended the first quarter with $473.0 million in cash, cash equivalents and short-term investments Company to host conference call and webcast today, May 6, 4: |
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| May 6, 2025 |
Targeted therapies for people of all ages May 2025 Day One Biopharmaceuticals Targeted therapies for people of all ages May 2025 Day One Biopharmaceuticals Disclaimer This presentation and the accompanying oral commentary contain forward-looking statements that are based on our management’s beliefs and assumptions and on information currently available to our management. |
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| April 11, 2025 |
l 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, 2024 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 001-40431 DAY ONE BIOPH |
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| April 11, 2025 |
UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 SCHEDULE 14A PROXY STATEMENT PURSUANT TO SECTION 14(A) OF THE SECURITIES EXCHANGE ACT OF 1934 Filed by the Registrant ☒ Filed by a Party other than the Registrant ☐ Check the appropriate box: ☐ Preliminary Proxy Statement ☐ Confidential, for Use of the Commission Only (as permitted by Rule 14a-6(e)(2)) ☐ Definitive Proxy St |
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| April 11, 2025 |
TABLE OF CONTENTS UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D. |
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| March 6, 2025 |
l UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 FORM 10-K/A (Amendment No. 1) (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, 2024 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 |
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| February 25, 2025 |
Subsidiaries of the Registrant Exhibit 21.1 Subsidiaries of Day One Biopharmaceuticals, Inc. None. |
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| February 25, 2025 |
Exhibit 97.1 Day One Biopharmaceuticals, Inc. Compensation Recovery Policy (Adopted December 5, 2023) The Board has determined that it is in the best interests of the Company and its stockholders to adopt this Policy enabling the Company to recover from specified current and former Company executives certain incentive-based compensation in the event of an accounting restatement resulting from mate |
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| February 25, 2025 |
UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 FORM 10-K l 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, 2024 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 001-40431 DAY ONE BIOPH |
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| February 25, 2025 |
Exhibit 19.1 1.0 Purpose Day One Biopharmaceuticals, Inc. (the “Company,” “we,” “us” or “our”) is committed to promoting high standards of honest and ethical business conduct and compliance with laws, rules and regulations. Because stock is an important part of the Company’s compensation program, our Board of Directors (“Board”) has adopted this Insider Trading Policy (“Policy”) governing the purc |
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| February 25, 2025 |
Day One Biopharmaceuticals FEBRUARY 2025 Fourth Quarter & Full-Year 2024 Financial Results & Corporate Progress Forward looking statements This presentation and the accompanying oral commentary contain forward-looking statements that are based on our management’s beliefs and assumptions and on information currently available to our management. |
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| February 25, 2025 |
Targeted therapies for people of all ages February 2025 Day One Biopharmaceuticals Targeted therapies for people of all ages February 2025 Day One Biopharmaceuticals Disclaimer This presentation and the accompanying oral commentary contain forward-looking statements that are based on our management’s beliefs and assumptions and on information currently available to our management. |
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| February 25, 2025 |
UNITED STATES SECURITIES AND EXCHANGE COMMISSION WASHINGTON, D.C. 20549 FORM 8-K CURRENT REPORT Pursuant to Section 13 or 15(d) of the Securities Exchange Act of 1934 Date of Report (Date of earliest event reported): February 25, 2025 DAY ONE BIOPHARMACEUTICALS, INC. (Exact name of registrant as specified in its charter) Delaware 001-40431 83-2415215 (State or other jurisdiction of incorporation) |
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| February 25, 2025 |
Exhibit 10.6 SUBLEASE THIS SUBLEASE (this “Sublease”) is dated for reference purposes as of June 26, 2024 (the “Effective Date”), and is made by and between Arcus Biosciences, Inc., a Delaware corporation (“Sublessor”), and Day One Biopharmaceuticals, Inc., a Delaware corporation (“Sublessee”). Sublessor and Sublessee hereby agree as follows: 1. Recitals: This Sublease is made with reference to th |
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| February 25, 2025 |
Exhibit 99.1 Day One Reports Fourth Quarter and Full Year 2024 Financial Results and Corporate Progress Achieved Q4 2024 and full year 2024 OJEMDATM (tovorafenib) net product revenues of $29.0 million and $57.2 million, respectively Ended 2024 with $531.7 million in cash, cash equivalents and short-term investments Company to host conference call and webcast today, February 25, 4:30 p.m. ET BRISBA |
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| February 14, 2025 |
EXHIBIT 99.1 JOINT FILING AGREEMENT This Joint Filing Agreement, dated as of February 14, 2025, is by and among RA Capital Management, L.P., Peter Kolchinsky, Rajeev Shah, and RA Capital Healthcare Fund, L.P. (the foregoing are collectively referred to herein as the “Filers”). Each of the Filers may be required to file with the United States Securities and Exchange Commission a statement on Schedu |
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| February 12, 2025 |
EX-99 2 exhibit99.txt Exhibit 99 Pursuant to the instructions in Item 7 of Schedule 13G, the following table lists the identity and Item 3 classification, if applicable, of each relevant entity that beneficially owns shares of the security class being reported on this Schedule 13G. Entity ITEM 3 Classification FIAM LLC IA Fidelity Institutional Asset Management Trust Company BK Fidelity Management |
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| January 13, 2025 |
Exhibit 99.2 Day One Biopharmaceuticals Targeted therapies for people of all ages January 2025 rd 43 Annual J.P. Morgan Healthcare Conference Forward looking statements This presentation and the accompanying oral commentary contain forward-looking statements that are based on our management’s beliefs and assumptions and on information currently available to our management. Forward-looking statemen |
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| January 13, 2025 |
Exhibit 99.3 Day One Biopharmaceuticals Targeted therapies for people of all ages January 2025 Disclaimer This presentation and the accompanying oral commentary contain forward-looking statements that are based on our management’s beliefs and assumptions and on information currently available to our management. Forward-looking statements are inherently subject to risks and uncertainties, some of w |
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| January 13, 2025 |
UNITED STATES SECURITIES AND EXCHANGE COMMISSION WASHINGTON, D.C. 20549 FORM 8-K CURRENT REPORT Pursuant to Section 13 or 15(d) of the Securities Exchange Act of 1934 Date of Report (Date of earliest event reported): (January 13, 2025) DAY ONE BIOPHARMACEUTICALS, INC. (Exact name of registrant as specified in its charter) Delaware 001-40431 83-2415215 (State or other jurisdiction of incorporation) |
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| January 13, 2025 |
Exhibit 99.1 Day One Reports Preliminary 2024 OJEMDA™ Net Product Revenue and Highlights 2025 Corporate Priorities Preliminary 2024 OJEMDA™ (tovorafenib) net product revenue of approximately $57.2 million (unaudited) First dose cohort cleared in Phase 1a/b clinical trial of DAY301 (PTK7-targeted ADC) Ended 2024 with approximately $531.7 million in cash, cash equivalents and short-term investments |
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| January 10, 2025 |
Exhibit 107 Calculation of Filing Fee Tables S-8 DAY ONE BIOPHARMACEUTICALS, INC. Table 1: Newly Registered Securities Security Type Security Class Title Fee Calculation Rule Amount Registered Proposed Maximum Offering Price Per Unit Maximum Aggregate Offering Price Fee Rate Amount of Registration Fee 1 Equity Common Stock, par value $0.0001 per share Other 5,131,836 $12.76 $65,482,227.36 0.00015 |
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| January 10, 2025 |
As filed with the Securities and Exchange Commission on January 10, 2025 As filed with the Securities and Exchange Commission on January 10, 2025 Registration No. |
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| November 20, 2024 |
UNITED STATES SECURITIES AND EXCHANGE COMMISSION WASHINGTON, D.C. 20549 FORM 8-K CURRENT REPORT Pursuant to Section 13 or 15(d) of the Securities Exchange Act of 1934 Date of Report (Date of earliest event reported): (November 20, 2024) DAY ONE BIOPHARMACEUTICALS, INC. (Exact name of registrant as specified in its charter) Delaware 001-40431 83-2415215 (State or other jurisdiction of incorporation |
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| November 14, 2024 |
DAWN / Day One Biopharmaceuticals, Inc. / Atlas Venture Fund XI, L.P. - SC 13G/A Passive Investment UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 SCHEDULE 13G/A Under the Securities Exchange Act of 1934 (Amendment No. 3)* DAY ONE BIOPHARMACEUTICALS, INC. (Name of Issuer) COMMON STOCK, $0.0001 PAR VALUE (Title of Class of Securities) 23954D 109 (CUSIP Number) September 30, 2024 (Date of Event Which Requires Filing of This Statement) Check the appropriate box to designate |
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| November 7, 2024 |
DAWN / Day One Biopharmaceuticals, Inc. / FMR LLC Passive Investment SC 13G 1 filing.txt SCHEDULE 13G Amendment No.0 DAY ONE BIOPHARMACEUTICALS INC COMMON STOCK Cusip #23954D109 Check the appropriate box to designate the rule pursuant to which this Schedule is filed: [x] Rule 13d-1(b) [ ] Rule 13d-1(c) [ ] Rule 13d-1(d) Cusip #23954D109 Item 1: Reporting Person - FMR LLC Item 2: (a) [ ] (b) [ ] Item 4: Delaware Item 5: 7,389,000 Item 6: 0 Item 7: 7,412,380 Item 8: |
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| November 7, 2024 |
DAWN / Day One Biopharmaceuticals, Inc. / FMR LLC Passive Investment SC 13G/A 1 filing.txt SCHEDULE 13G Amendment No.1 DAY ONE BIOPHARMACEUTICALS INC COMMON STOCK Cusip #23954D109 Check the appropriate box to designate the rule pursuant to which this Schedule is filed: [x] Rule 13d-1(b) [ ] Rule 13d-1(c) [ ] Rule 13d-1(d) Cusip #23954D109 Item 1: Reporting Person - FMR LLC Item 2: (a) [ ] (b) [ ] Item 4: Delaware Item 5: 11,265,165 Item 6: 0 Item 7: 11,287,327 Item |
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| October 30, 2024 |
f UNITED STATES SECURITIES AND EXCHANGE COMMISSION WASHINGTON, D.C. 20549 FORM 10-Q f UNITED STATES SECURITIES AND EXCHANGE COMMISSION WASHINGTON, D.C. 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 September 30, 2024 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: 001-40431 DAY |
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| October 30, 2024 |
UNITED STATES SECURITIES AND EXCHANGE COMMISSION WASHINGTON, D.C. 20549 FORM 8-K CURRENT REPORT Pursuant to Section 13 or 15(d) of the Securities Exchange Act of 1934 Date of Report (Date of earliest event reported): October 30, 2024 DAY ONE BIOPHARMACEUTICALS, INC. (Exact name of registrant as specified in its charter) Delaware 001-40431 83-2415215 (State or other jurisdiction of incorporation) ( |
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| October 30, 2024 |
Exhibit 10.1 CERTAIN CONFIDENTIAL INFORMATION CONTAINED IN THIS DOCUMENT, MARKED BY [*], HAS BEEN OMITTED BECAUSE IT IS NOT MATERIAL AND IS THE TYPE THAT THE REGISTRANT TREATS AS PRIVATE OR CONFIDENTIAL. EXCLUSIVE LICENSE AGREEMENT BY AND BETWEEN DAY ONE BIOPHARMACEUTICALS, INC. AND IPSEN PHARMA SAS JULY 23, 2024 37942/00605/FW/20045121.1 Confidential Execution Version EXCLUSIVE LICENSE AGREEMENT |
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| October 30, 2024 |
Exhibit 99.1 Day One Reports Third Quarter 2024 Financial Results and Corporate Progress Achieved $20.1 million in OJEMDATM (tovorafenib) net product revenue Ended the third quarter with $558.4 million in cash, cash equivalents and short-term investments Company to host conference call and webcast today, October 30, 4:30 p.m. Eastern Time BRISBANE, Calif., Oct. 30, 2024 – Day One Biopharmaceutical |
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| October 30, 2024 |
Third Quarter 2024 Financial Results and Corporate Progress October 2024 Nasdaq: DAWN Third Quarter 2024 Financial Results and Corporate Progress October 2024 Nasdaq: DAWN Forward-Looking Statements This presentation and the accompanying oral commentary contain forward-looking statements that are based on our management’s beliefs and assumptions and on information currently available to our management. |
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| October 30, 2024 |
Day One Biopharmaceuticals Targeted Therapies for People of All Ages October 2024 Day One Biopharmaceuticals Targeted Therapies for People of All Ages October 2024 Disclaimer This presentation and the accompanying oral commentary contain forward-looking statements that are based on our management’s beliefs and assumptions and on information currently available to our management. |
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| August 28, 2024 |
As filed with the Securities and Exchange Commission on August 28, 2024 Table of Contents As filed with the Securities and Exchange Commission on August 28, 2024 Registration No. |
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| August 28, 2024 |
EXHIBIT 107.1 CALCULATION OF FILING FEE TABLES Form S-3 (Form Type) Day One Biopharmaceuticals, Inc. (Exact Name of Registrant as Specified in its Charter) Table 1 - Newly Registered Securities Security Type Security Class Title Fee Calculation Rule Amount Registered Proposed Maximum Offering Price Per Unit Maximum Aggregate Offering Price Fee Rate Amount of Registration Fee Fees to be Paid Equity |
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| August 5, 2024 |
DAWN / Day One Biopharmaceuticals, Inc. / AI Day1 LLC - SC 13D/A Activist Investment SC 13D/A UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 SCHEDULE 13D Under the Securities Exchange Act of 1934 (Amendment No. 4)* Day One Biopharmaceuticals, Inc. (Name of Issuer) Common Stock, par value $0.0001 per share (Title of Class of Securities) 23954D109 (CUSIP Number) Alejandro Moreno Langhorne S. Perrow c/o Access Industries, Inc. 40 West 57th Street, 28th Floor |
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| August 5, 2024 |
EX-99.12 2 d881380dex9912.htm EX-99.12 Exhibit 99.12 Joint Filing Agreement The undersigned hereby agree that they are filing this statement jointly pursuant to Rule 13d-1(k)(1) promulgated under the Securities Exchange Act of 1934, as amended. Each of them is responsible for the timely filing of such Schedule 13D and any amendments thereto, and for the completeness and accuracy of the information |
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| August 2, 2024 |
f UNITED STATES SECURITIES AND EXCHANGE COMMISSION WASHINGTON, D.C. 20549 FORM 10-Q f UNITED STATES SECURITIES AND EXCHANGE COMMISSION WASHINGTON, D.C. 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, 2024 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: 001-40431 DAY ONE |
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| August 2, 2024 |
Exhibit 10.2 CONFIDENTIAL Execution Version CERTAIN CONFIDENTIAL INFORMATION CONTAINED IN THIS DOCUMENT, MARKED BY [*], HAS BEEN OMITTED BECAUSE IT IS NOT MATERIAL AND WOULD LIKELY CAUSE COMPETITIVE HARM TO DAY ONE BIOPHARMACEUTICALS, INC. IF PUBLICLY DISCLOSED. EXCLUSIVE LICENSE AGREEMENT BY AND BETWEEN MABCARE THERAPEUTICS (上海麦科思生物医药有限公司) AND DAY ONE BIOPHARMACEUTICALS, INC. JUNE 17, 2024 Table |
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| August 2, 2024 |
Asset Purchase Agreement, dated May 29, 2024. Exhibit 10.1 Execution Version CERTAIN CONFIDENTIAL INFORMATION CONTAINED IN THIS DOCUMENT, MARKED BY [*], HAS BEEN OMITTED BECAUSE IT IS NOT MATERIAL AND WOULD LIKELY CAUSE COMPETITIVE HARM TO DAY ONE BIOPHARMACEUTICALS IF PUBLICLY DISCLOSED. ASSET PURCHASE AGREEMENT BY AND BETWEEN [*] AND DAY ONE BIOPHARMACEUTICALS, INC. May 29, 2024 TABLE OF CONTENTS Page ARTICLE 1 DEFINITIONS 1 1.1 Certain Def |
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| July 30, 2024 |
Second Quarter 2024 Financial Results and Corporate Progress July 2024 Click to add text Nasdaq: DAWN Forward-Looking Statements This presentation and the accompanying oral commentary contain forward-looking statements that are based on our management’s beliefs and assumptions and on information currently available to our management. |
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| July 30, 2024 |
Exhibit 99.1 Day One Reports Second Quarter 2024 Financial Results and Corporate Progress Achieved $8.2 million in OJEMDATM (tovorafenib) net product revenues in initial 2 months of launch Expanded pipeline with DAY301, potential first-in-class Antibody Drug Conjugate (ADC) targeting PTK7 Entered into exclusive licensing agreement with Ipsen to commercialize tovorafenib outside of the U.S. for app |
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| July 30, 2024 |
Day One Announces Oversubscribed $175.0 Million Private Placement EX-99.1 Exhibit 99.1 Day One Announces Oversubscribed $175.0 Million Private Placement BRISBANE, Calif., July 30, 2024 – Day One Biopharmaceuticals, Inc. (Nasdaq: DAWN) (“Day One” or the “Company”), a commercial-stage biopharmaceutical company dedicated to developing and commercializing targeted therapies for people of all ages with life-threatening diseases, today announced it has entered into an |
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| July 30, 2024 |
Form of Registration Rights Agreement EX-10.2 Exhibit 10.2 REGISTRATION RIGHTS AGREEMENT THIS REGISTRATION RIGHTS AGREEMENT (this “Agreement”), dated as of July 30, 2024, is entered into by and among Day One Biopharmaceuticals, Inc., a Delaware corporation (the “Company”), and the several investors signatory hereto (individually as an “Investor” and collectively together with their respective permitted assigns, the “Investors”). Capit |
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| July 30, 2024 |
Form of Securities Purchase Agreement EX-10.1 Exhibit 10.1 SECURITIES PURCHASE AGREEMENT This SECURITIES PURCHASE AGREEMENT (this “Agreement”) is dated as of July 30, 2024, by and among Day One Biopharmaceuticals, Inc., a Delaware corporation (the “Company”), and each of the entities listed on Exhibit A attached to this Agreement (each, an “Investor” and together, the “Investors”). WHEREAS, the Company and the Investors are executing |
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| July 30, 2024 |
EX-4.1 Exhibit 4.1 THIS WARRANT AND THE SHARES OF COMMON STOCK ISSUABLE UPON THE EXERCISE OF THIS WARRANT (THE “SECURITIES”) HAVE NOT BEEN REGISTERED UNDER THE SECURITIES ACT OF 1933, AS AMENDED (THE “SECURITIES ACT”), OR THE SECURITIES LAWS OF ANY STATE OF THE UNITED STATES. THE SECURITIES HAVE BEEN ACQUIRED FOR INVESTMENT AND MAY NOT BE SOLD, TRANSFERRED OR ASSIGNED UNLESS (I) SUCH SECURITIES HA |
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| July 30, 2024 |
UNITED STATES SECURITIES AND EXCHANGE COMMISSION WASHINGTON, D.C. 20549 FORM 8-K CURRENT REPORT Pursuant to Section 13 or 15(d) of the Securities Exchange Act of 1934 Date of Report (Date of earliest event reported): July 30, 2024 DAY ONE BIOPHARMACEUTICALS, INC. (Exact name of registrant as specified in its charter) Delaware 001-40431 83-2415215 (State or other jurisdiction of incorporation) (Com |
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| July 30, 2024 |
UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 FORM 8-K CURRENT REPORT Pursuant to Section 13 or 15(d) of the Securities Exchange Act of 1934 Date of Report (Date of earliest event reported): (July 30, 2024) DAY ONE BIOPHARMACEUTICALS, INC. (Exact Name of Registrant as Specified in its Charter) Delaware 001-40431 83-2415215 (State or other jurisdiction of (Commission (I.R. |
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| July 30, 2024 |
Day One Biopharmaceuticals Targeted Therapies for People of All Ages July 2024 Day One Biopharmaceuticals Targeted Therapies for People of All Ages July 2024 Disclaimer This presentation and the accompanying oral commentary contain forward-looking statements that are based on our management’s beliefs and assumptions and on information currently available to our management. |
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| July 25, 2024 |
UNITED STATES SECURITIES AND EXCHANGE COMMISSION WASHINGTON, D.C. 20549 FORM 8-K CURRENT REPORT Pursuant to Section 13 or 15(d) of the Securities Exchange Act of 1934 Date of Report (Date of earliest event reported): July 23, 2024 Month DAY ONE BIOPHARMACEUTICALS, INC. (Exact name of registrant as specified in its charter) Delaware 001-40431 83-2415215 (State or other jurisdiction of incorporation |
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| July 25, 2024 |
EX-99.1 Exhibit 99.1 Ipsen and Day One enter into exclusive ex-U.S. licensing agreement to commercialize tovorafenib for the most common childhood brain tumor » Ipsen secures ex-U.S. regulatory and commercial rights to tovorafenib for most common childhood brain tumor, pediatric low-grade glioma (pLGG), and any future indications » OJEMDA™ (tovorafenib) is the first FDA-approved treatment for rela |
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| June 18, 2024 |
Exhibit 99.1 Day One Expands Pipeline with Potential First-in-Class Clinical-Stage Antibody Drug Conjugate (ADC) Targeting PTK7 in Solid Tumors for Adult and Pediatric Cancers Day One receives exclusive license for development and commercialization of MTX-13 (DAY301), which received IND clearance by the FDA in April 2024 Targets PTK7, highly expressed in broad range of adult and pediatric solid tu |
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| June 18, 2024 |
UNITED STATES SECURITIES AND EXCHANGE COMMISSION WASHINGTON, D.C. 20549 FORM 8-K CURRENT REPORT Pursuant to Section 13 or 15(d) of the Securities Exchange Act of 1934 Date of Report (Date of earliest event reported): June 17, 2024 Month DAY ONE BIOPHARMACEUTICALS, INC. (Exact name of registrant as specified in its charter) Delaware 001-40431 83-2415215 (State or other jurisdiction of incorporation |
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| June 18, 2024 |
Exhibit 99.2 Day One Biopharmaceuticals Targeted Therapies for People of All Ages June 2024 1 Disclaimer This presentation and the accompanying oral commentary contain forward-looking statements that are based on our management’s beliefs and assumptions and on information currently available to our management. Forward-looking statements are inherently subject to risks and uncertainties, some of wh |
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| June 12, 2024 |
EX-99.1 Exhibit 99.1 Day One Biopharmaceuticals Targeted Therapies for People of All Ages June 2024 1 Disclaimer This presentation and the accompanying oral commentary contain forward-looking statements that are based on our management’s beliefs and assumptions and on information currently available to our management. Forward-looking statements are inherently subject to risks and uncertainties, so |
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| June 12, 2024 |
UNITED STATES SECURITIES AND EXCHANGE COMMISSION WASHINGTON, D.C. 20549 FORM 8-K CURRENT REPORT Pursuant to Section 13 or 15(d) of the Securities Exchange Act of 1934 Date of Report (Date of earliest event reported): (June 12, 2024) DAY ONE BIOPHARMACEUTICALS, INC. (Exact name of registrant as specified in its charter) Delaware 001-40431 83-2415215 (State or other jurisdiction of incorporation) (C |
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| May 30, 2024 |
UNITED STATES SECURITIES AND EXCHANGE COMMISSION WASHINGTON, D.C. 20549 FORM 8-K CURRENT REPORT Pursuant to Section 13 or 15(d) of the Securities Exchange Act of 1934 Date of Report (Date of earliest event reported): (May 29, 2024) DAY ONE BIOPHARMACEUTICALS, INC. (Exact name of registrant as specified in its charter) Delaware 001-40431 83-2415215 (State or other jurisdiction of incorporation) (Co |
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| May 30, 2024 |
Exhibit 99.2 Day One Biopharmaceuticals Targeted Therapies for People of All Ages May 2024 1 Disclaimer This presentation and the accompanying oral commentary contain forward-looking statements that are based on our management’s beliefs and assumptions and on information currently available to our management. Forward-looking statements are inherently subject to risks and uncertainties, some of whi |
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| May 30, 2024 |
Day One Announces Sale of Priority Review Voucher for $108 Million Exhibit 99.1 Day One Announces Sale of Priority Review Voucher for $108 Million BRISBANE, Calif., May 30, 2024 — Day One Biopharmaceuticals (Nasdaq: DAWN) (“Day One” or the “Company”), a commercial-stage biopharmaceutical company dedicated to developing and commercializing targeted therapies for people of all ages with life-threatening diseases, today announced it sold its Priority Review Voucher |
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| May 24, 2024 |
UNITED STATES SECURITIES AND EXCHANGE COMMISSION WASHINGTON, D.C. 20549 FORM 8-K CURRENT REPORT Pursuant to Section 13 or 15(d) of the Securities Exchange Act of 1934 Date of Report (Date of earliest event reported): (May 23, 2024) DAY ONE BIOPHARMACEUTICALS, INC. (Exact name of registrant as specified in its charter) Delaware 001-40431 83-2415215 (State or other jurisdiction of incorporation) (Co |
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| May 6, 2024 |
f UNITED STATES SECURITIES AND EXCHANGE COMMISSION WASHINGTON, D.C. 20549 FORM 10-Q f UNITED STATES SECURITIES AND EXCHANGE COMMISSION WASHINGTON, D.C. 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, 2024 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: 001-40431 DAY ONE |
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| May 6, 2024 |
UNITED STATES SECURITIES AND EXCHANGE COMMISSION WASHINGTON, D.C. 20549 FORM 8-K CURRENT REPORT Pursuant to Section 13 or 15(d) of the Securities Exchange Act of 1934 Date of Report (Date of earliest event reported): May 06, 2024 DAY ONE BIOPHARMACEUTICALS, INC. (Exact name of registrant as specified in its charter) Delaware 001-40431 83-2415215 (State or other jurisdiction of incorporation) (Comm |
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| May 6, 2024 |
Day One Biopharmaceuticals Targeted Therapies for People of All Ages May 2024 Day One Biopharmaceuticals Targeted Therapies for People of All Ages May 2024 Disclaimer This presentation and the accompanying oral commentary contain forward-looking statements that are based on our management’s beliefs and assumptions and on information currently available to our management. |
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| May 6, 2024 |
Exhibit 99.1 Day One Reports First Quarter 2024 Financial Results and Corporate Progress OJEMDA™ (tovorafenib) launch underway following U.S. FDA accelerated approval for relapsed or refractory BRAF-altered Pediatric Low-Grade Glioma (pLGG) First prescriptions received in the U.S. BRISBANE, Calif., May 6, 2024 – Day One Biopharmaceuticals (Nasdaq: DAWN) (“Day One” or the “Company”), a commercial-s |
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| April 24, 2024 |
Exhibit 99.2 Day One Biopharmaceuticals Targeted Therapies for People of All Ages April 2024 1 Disclaimer This presentation and the accompanying oral commentary contain forward-looking statements that are based on our management’s beliefs and assumptions and on information currently available to our management. Forward-looking statements are inherently subject to risks and uncertainties, some of w |
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| April 24, 2024 |
UNITED STATES SECURITIES AND EXCHANGE COMMISSION WASHINGTON, D.C. 20549 FORM 8-K CURRENT REPORT Pursuant to Section 13 or 15(d) of the Securities Exchange Act of 1934 Date of Report (Date of earliest event reported): (April 23, 2024) DAY ONE BIOPHARMACEUTICALS, INC. (Exact name of registrant as specified in its charter) Delaware 001-40431 83-2415215 (State or other jurisdiction of incorporation) ( |
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| April 24, 2024 |
Exhibit 99.1 Day One’s OJEMDA™ (tovorafenib) Receives US FDA Accelerated Approval for Relapsed or Refractory BRAF-altered Pediatric Low-Grade Glioma (pLGG), the Most Common Form of Childhood Brain Tumor First and only FDA-approved type II RAF inhibitor for patients with relapsed or refractory pLGG harboring a BRAF fusion or rearrangement, or BRAF V600 mutation RAPNO LGG overall response rate (ORR) |
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| April 5, 2024 |
UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 SCHEDULE 14A PROXY STATEMENT PURSUANT TO SECTION 14(A) OF THE SECURITIES EXCHANGE ACT OF 1934 Filed by the Registrant ☒ Filed by a Party other than the Registrant ☐ Check the appropriate box: ☐ Preliminary Proxy Statement ☐ Confidential, for Use of the Commission Only (as permitted by Rule 14a-6(e)(2)) ☐ Definitive Proxy St |
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| April 5, 2024 |
TABLE OF CONTENTS UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D. |
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| April 5, 2024 |
l 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, 2023 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 001-40431 DAY ONE BIOPH |
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| March 7, 2024 |
Exhibit 10.1 [*] = Certain confidential information contained in this document, marked by brackets, has been omitted because it is both (i) not material and (ii) is the type that the registrant treats as private or confidential. AMENDMENT NO. 1 TO LICENSE AGREEMENT FOR RAF This Amendment No. 1 to License Agreement for RAF (this “Amendment”), effective as of March 4, 2024 (the “Amendment Effective |
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| March 7, 2024 |
UNITED STATES SECURITIES AND EXCHANGE COMMISSION WASHINGTON, D.C. 20549 FORM 8-K CURRENT REPORT Pursuant to Section 13 or 15(d) of the Securities Exchange Act of 1934 Date of Report (Date of earliest event reported): March 4, 2024 DAY ONE BIOPHARMACEUTICALS, INC. (Exact name of registrant as specified in its charter) Delaware 001-40431 83-2415215 (State or other jurisdiction of incorporation) (Com |
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| February 26, 2024 |
Exhibit 99.1 Day One Reports Fourth Quarter and Full Year 2023 Financial Results and Corporate Progress PDUFA target action date for tovorafenib NDA in relapsed or progressive pLGG remains set for April 30, 2024 Phase 2 FIREFLY-1 tovorafenib registrational data published in Nature Medicine Ended 2023 with $366.3 million in cash, cash equivalents and short-term investments providing runway into 202 |
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| February 26, 2024 |
Exhibit 97.1 Day One Biopharmaceuticals, Inc. Compensation Recovery Policy (Adopted December 5, 2023) The Board has determined that it is in the best interests of the Company and its stockholders to adopt this Policy enabling the Company to recover from specified current and former Company executives certain incentive-based compensation in the event of an accounting restatement resulting from mate |
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| February 26, 2024 |
UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 FORM 10-K l 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, 2023 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 001-40431 DAY ONE BIOPH |
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| February 26, 2024 |
UNITED STATES SECURITIES AND EXCHANGE COMMISSION WASHINGTON, D.C. 20549 FORM 8-K CURRENT REPORT Pursuant to Section 13 or 15(d) of the Securities Exchange Act of 1934 Date of Report (Date of earliest event reported): February 26, 2024 DAY ONE BIOPHARMACEUTICALS, INC. (Exact name of Registrant as Specified in Its Charter) Delaware 001-40431 83-2415215 (State or Other Jurisdiction of Incorporation) |
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| February 26, 2024 |
Subsidiaries of the Registrant Exhibit 21.1 Subsidiaries of Day One Biopharmaceuticals, Inc. None. |
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| February 26, 2024 |
Day One Biopharmaceuticals Targeted Therapies for People of All Ages February 2024 Day One Biopharmaceuticals Targeted Therapies for People of All Ages February 2024 Disclaimer This presentation and the accompanying oral commentary contain forward-looking statements that are based on our management’s beliefs and assumptions and on information currently available to our management. |
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| February 14, 2024 |
Exhibit 1: Joint Filing Agreement EX-99.1 2 tm246065d8ex1.htm EXHIBIT 1 EXHIBIT 1 AGREEMENT This Joint Filing Agreement, dated as of February 14, 2024, is by and among RA Capital Management, L.P., Peter Kolchinsky, Rajeev Shah, and RA Capital Healthcare Fund, L.P. (the foregoing are collectively referred to herein as the “Filers”). Each of the Filers may be required to file with the United States Securities and Exchange Commission |
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| February 14, 2024 |
DAWN / Day One Biopharmaceuticals, Inc. / RA CAPITAL MANAGEMENT, L.P. - SC 13G/A Passive Investment SC 13G/A 1 tm246065d8sc13ga.htm SC 13G/A UNITED STATES SECURITIES AND EXCHANGE COMMISSION WASHINGTON, D.C. 20549 SCHEDULE 13G/A Under the Securities Exchange Act of 1934 (Amendment No. 2)* Day One Biopharmaceuticals, Inc. (Name of Issuer) Common Stock, par value $0.0001 per share (Title of Class of Securities) 23954D109 (CUSIP Number) December 31, 2023 (Date of Event Which Requires Filing of this |
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| February 13, 2024 |
DAWN / Day One Biopharmaceuticals, Inc. / VANGUARD GROUP INC - SCHEDULE 13G Passive Investment SC 13G 1 tv0736-dayonebiopharmaceutic.htm SCHEDULE 13G SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 Schedule 13G Under the Securities Exchange Act of 1934 Name of issuer: Day One Biopharmaceuticals Inc Title of Class of Securities: Common Stock CUSIP Number: 23954D109 Date of Event Which Requires Filing of this Statement: December 29, 2023 Check the appropriate box to designate the ru |
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| February 9, 2024 |
DAWN / Day One Biopharmaceuticals, Inc. / Atlas Venture Fund XI, L.P. - SC 13G/A Passive Investment SC 13G/A 1 tm245803d1sc13ga.htm SC 13G/A UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 SCHEDULE 13G/A Under the Securities Exchange Act of 1934 (Amendment No. 2)* DAY ONE BIOPHARMACEUTICALS, INC. (Name of Issuer) COMMON STOCK, $0.0001 PAR VALUE (Title of Class of Securities) 23954D 109 (CUSIP Number) December 31, 2023 (Date of Event Which Requires Filing of This Statement |
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| February 9, 2024 |
DAWN / Day One Biopharmaceuticals, Inc. / FMR LLC Passive Investment SCHEDULE 13G Amendment No.3 DAY ONE BIOPHARMACEUTICALS INC COMMON STOCK Cusip #23954D109 Check the appropriate box to designate the rule pursuant to which this Schedule is filed: [x] Rule 13d-1(b) [ ] Rule 13d-1(c) [ ] Rule 13d-1(d) Cusip #23954D109 Item 1: Reporting Person - FMR LLC Item 2: (a) [ ] (b) [ ] Item 4: Delaware Item 5: 3,941,117 Item 6: 0 Item 7: 3,968,166 Item 8: 0 Item 9: 3,968,166 |
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| January 29, 2024 |
DAWN / Day One Biopharmaceuticals, Inc. / BlackRock Inc. Passive Investment us23954d1090012924.txt SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 SCHEDULE 13G Under the Securities Exchange Act of 1934 (Amendment No: ) DAY ONE BIOPHARMACEUTICALS, INC. - (Name of Issuer) Common Stock - (Title of Class of Securities) 23954D109 - (CUSIP Number) December 31, 2023 - (Date of Event Which Requires Filing of this Statement) Check the appropriate box to designate the rul |
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| January 17, 2024 |
Day One Announces Two New Appointments to Board of Directors EX-99.1 Exhibit 99.1 Day One Announces Two New Appointments to Board of Directors BRISBANE, Calif., January 17, 2024 – Day One Biopharmaceuticals (Nasdaq: DAWN) (“Day One” or the “Company”), a clinical-stage biopharmaceutical company dedicated to developing and commercializing targeted therapies for people of all ages with life-threatening diseases, today announced the appointments of Habib Dable |
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| January 17, 2024 |
UNITED STATES SECURITIES AND EXCHANGE COMMISSION WASHINGTON, D.C. 20549 FORM 8-K CURRENT REPORT Pursuant to Section 13 or 15(d) of the Securities Exchange Act of 1934 Date of Report (Date of earliest event reported): (January 16, 2024) DAY ONE BIOPHARMACEUTICALS, INC. (Exact name of registrant as specified in its charter) Delaware 001-40431 83-2415215 (State or other jurisdiction of incorporation) |
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| January 8, 2024 |
Exhibit 99.2 Day One Biopharmaceuticals Targeted Therapies for People of All Ages January 2024 1 Disclaimer This presentation and the accompanying oral commentary contain forward-looking statements that are based on our management’s beliefs and assumptions and on information currently available to our management. Forward-looking statements are inherently subject to risks and uncertainties, some of |
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| January 8, 2024 |
UNITED STATES SECURITIES AND EXCHANGE COMMISSION WASHINGTON, D.C. 20549 FORM 8-K CURRENT REPORT Pursuant to Section 13 or 15(d) of the Securities Exchange Act of 1934 Date of Report (Date of earliest event reported): (January 8, 2024) DAY ONE BIOPHARMACEUTICALS, INC. (Exact name of registrant as specified in its charter) Delaware 001-40431 83-2415215 (State or other jurisdiction of incorporation) |
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| January 8, 2024 |
Exhibit 99.1 Nasdaq: DAWN Day One Biopharmaceuticals Targeted Therapies for People of All Ages nd 42 Annual J.P. Morgan Healthcare Conference January 2024 1 Disclaimer This presentation and the accompanying oral commentary contain forward-looking statements that are based on our management’s beliefs and assumptions and on information currently available to our management. Forward-looking statement |
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| January 4, 2024 |
2021 Equity Incentive Plan and forms of award agreements Exhibit 99.1 DAY ONE BIOPHARMACEUTICALS, INC. 2021 EQUITY INCENTIVE PLAN 1. PURPOSE. The purpose of this Plan is to provide incentives to attract, retain, and motivate eligible persons whose present and potential contributions are important to the success of the Company, and any Parents, Subsidiaries, and Affiliates that exist now or in the future, by offering them an opportunity to participate in |
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| January 4, 2024 |
Exhibit 107 Calculation of Filing Fee Tables Form S-8 (Form Type) Day One Biopharmaceuticals, Inc. |
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| January 4, 2024 |
2021 Employee Stock Purchase Plan and forms of award agreements Exhibit 99.2 DAY ONE BIOPHARMACEUTICALS, INC. 2021 EMPLOYEE STOCK PURCHASE PLAN 1. PURPOSE. Day One Biopharmaceuticals, Inc. adopted the Plan effective as of the Effective Date. The purpose of this Plan is to provide eligible employees of the Company and the Participating Corporations with a means of acquiring an equity interest in the Company, to enhance such employees’ sense of participation in |
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| January 4, 2024 |
As filed with the Securities and Exchange Commission on January 4, 2024 S-8 As filed with the Securities and Exchange Commission on January 4, 2024 Registration No. |
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| December 8, 2023 |
UNITED STATES SECURITIES AND EXCHANGE COMMISSION WASHINGTON, D.C. 20549 FORM 8-K CURRENT REPORT Pursuant to Section 13 or 15(d) of the Securities Exchange Act of 1934 Date of Report (Date of earliest event reported): (December 7, 2023) DAY ONE BIOPHARMACEUTICALS, INC. (Exact name of registrant as specified in its charter) Delaware 001-40431 83-2415215 (State or other jurisdiction of incorporation) |
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| December 8, 2023 |
Code of Business Conduct and Ethics Exhibit 14.1 DAY ONE BIOPHARMACEUTICALS, INC. CODE OF BUSINESS CONDUCT AND ETHICS THIS POLICY WAS APPROVED BY THE BOARD ON DECEMBER 7, 2023 PURPOSE Our integrity and professionalism have been the cornerstone of our business. In all that we do Day One Biopharmaceuticals, Inc. (the “Company”) supports and upholds a set of core values and principles. The success of our business depends on each of us |
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| November 17, 2023 |
Exhibit 99.2 Day One Biopharmaceuticals Targeted Therapies for People of All Ages November 2023 Disclaimer This presentation and the accompanying oral commentary contain forward-looking statements that are based on our management’s beliefs and assumptions and on information currently available to our management. Forward-looking statements are inherently subject to risks and uncertainties, some of |
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| November 17, 2023 |
Regulation FD Disclosure, Financial Statements and Exhibits UNITED STATES SECURITIES AND EXCHANGE COMMISSION WASHINGTON, D.C. 20549 FORM 8-K CURRENT REPORT Pursuant to Section 13 or 15(d) of the Securities Exchange Act of 1934 Date of Report (Date of earliest event reported): (November 17, 2023) DAY ONE BIOPHARMACEUTICALS, INC. (Exact name of registrant as specified in its charter) Delaware 001-40431 83-2415215 (State or other jurisdiction of incorporation |
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| November 17, 2023 |
Exhibit 99.1 Day One Announces Tovorafenib FIREFLY-1 Data Published in Nature Medicine Data subsets to be shared today in plenary oral presentations at the 2023 Society for Neuro-Oncology Annual Meeting BRISBANE, Calif., Nov. 17, 2023 – Day One Biopharmaceuticals (Nasdaq: DAWN) (“Day One” or the “Company”), a clinical-stage biopharmaceutical company dedicated to developing and commercializing targ |
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| November 15, 2023 |
Letter from Ernst & Young LLP, dated November 15, 2023. Exhibit 16.1 November 15, 2023 Securities and Exchange Commission 100 F Street, N.E. Washington, DC 20549 Commissioners: We have read Item 4.01 of Form 8-K dated November 15, 2023, of Day One Biopharmaceuticals, Inc. and are in agreement with the statements contained in the first, second, third and fourth paragraphs included in Item 4.01(a) therein. We have no basis to agree or disagree with other |
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| November 15, 2023 |
UNITED STATES SECURITIES AND EXCHANGE COMMISSION WASHINGTON, D.C. 20549 FORM 8-K CURRENT REPORT Pursuant to Section 13 or 15(d) of the Securities Exchange Act of 1934 Date of Report (Date of earliest event reported): (November 10, 2023) DAY ONE BIOPHARMACEUTICALS, INC. (Exact name of registrant as specified in its charter) Delaware 001-40431 83-2415215 (State or other jurisdiction of incorporation |
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| November 6, 2023 |
Exhibit 99.1 Day One Reports Third Quarter 2023 Financial Results and Corporate Progress NDA for tovorafenib in relapsed or progressive pLGG accepted for FDA priority review PDUFA target action date of April 30, 2024 BRISBANE, Calif., Nov. 6, 2023 – Day One Biopharmaceuticals (Nasdaq: DAWN) (“Day One” or the “Company”), a clinical-stage biopharmaceutical company dedicated to developing and commerc |
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| November 6, 2023 |
f UNITED STATES SECURITIES AND EXCHANGE COMMISSION WASHINGTON, D.C. 20549 FORM 10-Q f UNITED STATES SECURITIES AND EXCHANGE COMMISSION WASHINGTON, D.C. 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 September 30, 2023 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: 001-40431 DAY |
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| November 6, 2023 |
Day One Biopharmaceuticals Targeted Therapies for People of All Ages November 2023 Day One Biopharmaceuticals Targeted Therapies for People of All Ages November 2023 Disclaimer This presentation and the accompanying oral commentary contain forward-looking statements that are based on our management’s beliefs and assumptions and on information currently available to our management. |
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| November 6, 2023 |
UNITED STATES SECURITIES AND EXCHANGE COMMISSION WASHINGTON, D.C. 20549 FORM 8-K CURRENT REPORT Pursuant to Section 13 or 15(d) of the Securities Exchange Act of 1934 Date of Report (Date of earliest event reported): November 06, 2023 DAY ONE BIOPHARMACEUTICALS, INC. (Exact name of registrant as specified in its charter) Delaware 001-40431 83-2415215 (State or other jurisdiction of incorporation) |
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| October 30, 2023 |
Exhibit 99.1 Day One Announces FDA Acceptance of NDA and Priority Review for Tovorafenib in Relapsed or Progressive Pediatric Low-Grade Glioma (pLGG) Priority review granted with PDUFA target action date of April 30, 2024 BRISBANE, Calif., Oct. 30, 2023 – Day One Biopharmaceuticals (Nasdaq: DAWN) (“Day One” or the “Company”), a clinical-stage biopharmaceutical company dedicated to developing and c |
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| October 30, 2023 |
UNITED STATES SECURITIES AND EXCHANGE COMMISSION WASHINGTON, D.C. 20549 FORM 8-K CURRENT REPORT Pursuant to Section 13 or 15(d) of the Securities Exchange Act of 1934 Date of Report (Date of earliest event reported): (October 30, 2023) DAY ONE BIOPHARMACEUTICALS, INC. (Exact name of registrant as specified in its charter) Delaware 001-40431 83-2415215 (State or other jurisdiction of incorporation) |
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| October 30, 2023 |
Exhibit 99.2 Day One Biopharmaceuticals Targeted Therapies for People of All Ages October 2023 Disclaimer This presentation and the accompanying oral commentary contain forward-looking statements that are based on our management’s beliefs and assumptions and on information currently available to our management. Forward-looking statements are inherently subject to risks and uncertainties, some of w |
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| October 20, 2023 |
DAWN / Day One Biopharmaceuticals Inc / AI Day1 LLC - SC 13D/A Activist Investment SC 13D/A UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 SCHEDULE 13D Under the Securities Exchange Act of 1934 (Amendment No. 3)* Day One Biopharmaceuticals, Inc. (Name of Issuer) Common Stock, par value $0.0001 per share (Title of Class of Securities) 23954D109 (CUSIP Number) Alejandro Moreno Langhorne S. Perrow c/o Access Industries, Inc. 40 West 57th Street, 28th Floor |
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| October 20, 2023 |
EX-99.9 2 d514379dex999.htm EX-99.9 Exhibit 99.9 Joint Filing Agreement The undersigned hereby agree that they are filing this statement jointly pursuant to Rule 13d-1(k)(1) promulgated under the Securities Exchange Act of 1934, as amended. Each of them is responsible for the timely filing of such Schedule 13D and any amendments thereto, and for the completeness and accuracy of the information con |
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| September 14, 2023 |
Exhibit 4.3 FORM OF DEBT SECURITY [Face of Security] DAY ONE BIOPHARMACEUTICALS, INC. [If applicable, insert—FOR PURPOSES OF THE ORIGINAL ISSUE DISCOUNT PROVISIONS OF THE INTERNAL REVENUE CODE OF 1986, THE ISSUE PRICE OF THIS SECURITY IS % OF ITS PRINCIPAL AMOUNT AT STATED MATURITY SET FORTH BELOW (ITS “PRINCIPAL AMOUNT”), THE AMOUNT OF ORIGINAL ISSUE DISCOUNT IS % OF ITS PRINCIPAL AMOUNT, THE YIE |
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| September 14, 2023 |
As filed with the Securities and Exchange Commission on September 14, 2023 Table of Contents As filed with the Securities and Exchange Commission on September 14, 2023 Registration No. |
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| September 14, 2023 |
Exhibit 4.4 DAY ONE BIOPHARMACEUTICALS, INC. And , as Trustee INDENTURE Dated as of , TABLE OF CONTENTS ARTICLE 1 – DEFINITIONS AND INCORPORATION BY REFERENCE 1 1.1 DEFINITIONS 1 1.2. OTHER DEFINITIONS 4 1.3. INCORPORAT ION BY REFERENCE OF TRUST INDENTURE ACT 4 1.4. RULES OF CONSTRUCTION 5 ARTICLE 2 – THE SECURITIES 5 2.1. ISSUABLE IN SERIES 5 2.2. ESTABLISHMENT OF TERMS OF SERIES OF SECURITIES 5 |
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| September 14, 2023 |
Exhibit 107 Calculation of Filing Fee Tables Form S-3ASR (Form Type) Day One Biopharmaceuticals, Inc. |
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| September 11, 2023 |
EX-99.1 Exhibit 99.1 Day One Announces Updated FIREFLY-1 Data for Tovorafenib and Completion of Rolling NDA Submission to FDA for Relapsed or Progressive Pediatric Low-Grade Glioma (pLGG) Overall response rate (ORR) greater than 50% across three assessment criteria Median duration of tovorafenib treatment of 15.8 months as of June 5, 2023, with 66% of patients remaining on treatment FDA filing dec |
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| September 11, 2023 |
Exhibit 99.2 Day One Biopharmaceuticals Targeted Therapies for People of All Ages September 2023 Disclaimer This presentation and the accompanying oral commentary contain forward-looking statements that are based on our management’s beliefs and assumptions and on information currently available to our management. Forward-looking statements are inherently subject to risks and uncertainties, some of |
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| September 11, 2023 |
UNITED STATES SECURITIES AND EXCHANGE COMMISSION WASHINGTON, D.C. 20549 FORM 8-K CURRENT REPORT Pursuant to Section 13 or 15(d) of the Securities Exchange Act of 1934 Date of Report (Date of earliest event reported): (September 11, 2023) DAY ONE BIOPHARMACEUTICALS, INC. (Exact name of registrant as specified in its charter) Delaware 001-40431 83-2415215 (State or other jurisdiction of incorporatio |
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| August 16, 2023 |
Exhibit 99.2 Day One Biopharmaceuticals Targeted Therapies for People of All Ages August 2023 Day One Biopharmaceuticals Disclaimer This presentation and the accompanying oral commentary contain forward-looking statements that are based on our management’s beliefs and assumptions and on information currently available to our management. Forward-looking statements are inherently subject to risks an |
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| August 16, 2023 |
UNITED STATES SECURITIES AND EXCHANGE COMMISSION WASHINGTON, D.C. 20549 FORM 8-K CURRENT REPORT Pursuant to Section 13 or 15(d) of the Securities Exchange Act of 1934 Date of Report (Date of earliest event reported): (August 16, 2023) DAY ONE BIOPHARMACEUTICALS, INC. (Exact name of registrant as specified in its charter) Delaware 001-40431 83-2415215 (State or other jurisdiction of incorporation) |
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| August 16, 2023 |
EX-99.1 Exhibit 99.1 Day One Announces VRK1 License Agreement and Research Collaboration with Sprint Bioscience Day One receives an exclusive license to develop and commercialize small molecule drug candidates for pediatric and adult cancers with high unmet need Collaboration augments Day One’s portfolio of targeted therapies in oncology BRISBANE, Calif., Aug. 15, 2023 – Day One Biopharmaceuticals |
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| August 10, 2023 |
DAWN / Day One Biopharmaceuticals Inc / FMR LLC Passive Investment SCHEDULE 13G Amendment No.2 DAY ONE BIOPHARMACEUTICALS INC COMMON STOCK Cusip #23954D109 Check the appropriate box to designate the rule pursuant to which this Schedule is filed: [x] Rule 13d-1(b) [ ] Rule 13d-1(c) [ ] Rule 13d-1(d) Cusip #23954D109 Item 1: Reporting Person - FMR LLC Item 2: (a) [ ] (b) [ ] Item 4: Delaware Item 5: 5,989,647 Item 6: 0 Item 7: 6,019,058 Item 8: 0 Item 9: 6,019,058 |
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| August 7, 2023 |
Exhibit 99.1 Day One Reports Second Quarter 2023 Financial Results and Corporate Progress Results from FIREFLY-1 demonstrate overall response rate (ORR) of 67% and clinical benefit rate (CBR) of 93% in 69 heavily pretreated Response Assessment Neuro-Oncology High-Grade Glioma (RANO-HGG) evaluable patients presented at the 2023 American Society of Clinical Oncology (ASCO) Annual Meeting Initiated r |
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| August 7, 2023 |
Restated Certificate of Incorporation, dated June 1, 2021, as amended June 22, 2023. Exhibit 3.1 CERTIFICATE OF AMENDMENT OF RESTATED CERTIFICATE OF INCORPORATION OF DAY ONE BIOPHARMACEUTICALS, INC. Day One Biopharmaceuticals, Inc. (hereinafter called the “Corporation”), a corporation organized and existing under and by virtue of the General Corporation Law of the State of Delaware (the “General Corporation Law”), does hereby certify as follows: 1. That the name of this Corporatio |
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| August 7, 2023 |
f UNITED STATES SECURITIES AND EXCHANGE COMMISSION WASHINGTON, D.C. 20549 FORM 10-Q f UNITED STATES SECURITIES AND EXCHANGE COMMISSION WASHINGTON, D.C. 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, 2023 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: 001-40431 DAY ONE |
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| August 7, 2023 |
Day One Biopharmaceuticals Targeted Therapies for People of All Ages August 2023 Day One Biopharmaceuticals Disclaimer Day One Biopharmaceuticals This presentation and the accompanying oral commentary contain forward-looking statements that are based on our management’s beliefs and assumptions and on information currently available to our management. |
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| August 7, 2023 |
UNITED STATES SECURITIES AND EXCHANGE COMMISSION WASHINGTON, D.C. 20549 FORM 8-K CURRENT REPORT Pursuant to Section 13 or 15(d) of the Securities Exchange Act of 1934 Date of Report (Date of earliest event reported): August 07, 2023 DAY ONE BIOPHARMACEUTICALS, INC. (Exact name of registrant as specified in its charter) Delaware 001-40431 83-2415215 (State or other jurisdiction of incorporation) (C |
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| June 23, 2023 |
UNITED STATES SECURITIES AND EXCHANGE COMMISSION WASHINGTON, D.C. 20549 FORM 8-K CURRENT REPORT Pursuant to Section 13 or 15(d) of the Securities Exchange Act of 1934 Date of Report (Date of earliest event reported): (June 22, 2023) DAY ONE BIOPHARMACEUTICALS, INC. (Exact name of registrant as specified in its charter) Delaware 001-40431 83-2415215 (State or other jurisdiction of incorporation) (C |
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| June 23, 2023 |
Certificate of Amendment to Restated Certificate of Incorporation, filed June 22, 2023. EX-3.1 Exhibit 3.1 CERTIFICATE OF AMENDMENT OF RESTATED CERTIFICATE OF INCORPORATION OF DAY ONE BIOPHARMACEUTICALS, INC. Day One Biopharmaceuticals, Inc. (hereinafter called the “Corporation”), a corporation organized and existing under and by virtue of the General Corporation Law of the State of Delaware (the “General Corporation Law”), does hereby certify as follows: 1. That the name of this Cor |
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| June 12, 2023 |
DAWN / Day One Biopharmaceuticals Inc / AI Day1 LLC - SC 13D/A Activist Investment SC 13D/A UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 SCHEDULE 13D Under the Securities Exchange Act of 1934 (Amendment No. 2)* Day One Biopharmaceuticals, Inc. (Name of Issuer) Common Stock, par value $0.0001 per share (Title of Class of Securities) 23954D109 (CUSIP Number) Alejandro Moreno Langhorne S. Perrow c/o Access Industries, Inc. 40 West 57th Street, 28th Floor |
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| June 12, 2023 |
EX-99.8 Exhibit 99.8 Joint Filing Agreement The undersigned hereby agree that they are filing this statement jointly pursuant to Rule 13d-1(k)(1) promulgated under the Securities Exchange Act of 1934, as amended. Each of them is responsible for the timely filing of such Schedule 13D and any amendments thereto, and for the completeness and accuracy of the information concerning such person containe |
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| June 12, 2023 |
UNITED STATES SECURITIES AND EXCHANGE COMMISSION WASHINGTON, D.C. 20549 FORM 8-K CURRENT REPORT Pursuant to Section 13 or 15(d) of the Securities Exchange Act of 1934 Date of Report (Date of earliest event reported): June 12, 2023 Month DAY ONE BIOPHARMACEUTICALS, INC. (Exact name of registrant as specified in its charter) Delaware 001-40431 83-2415215 (State or other jurisdiction of incorporation |
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| June 12, 2023 |
EX-99.1 Exhibit 99.1 Day One Biopharmaceuticals Targeted Therapies for People of All Ages June 2023 Day One Biopharmaceuticals Disclaimer This presentation and the accompanying oral commentary contain forward-looking statements that are based on our management’s beliefs and assumptions and on information currently available to our management. Forward-looking statements are inherently subject to ri |
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| June 7, 2023 |
424B5 Table of Contents Filed Pursuant to Rule 424(b)(5) Registration No. 333-265346 Prospectus supplement (To prospectus dated June 13, 2022) 11,538,462 shares Common stock We are offering 11,538,462 shares of our common stock. Our common stock is listed on The Nasdaq Global Select Market under the symbol “DAWN.” The last reported sale price of our common stock on The Nasdaq Global Select Market |
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| June 7, 2023 |
Underwriting Agreement, dated June 6, 2023. U.S. Securities and Exchange Commission Youâve Exceeded the SECâs Traffic Limit Your request rate has exceeded the SECâs maximum allowable requests per second. Your access to SEC.gov will be limited for 10 minutes. Current guidelines limit each user to a total of no more than 10 requests per second, regardless of the number of machines used to submit requests. To ensure that SEC.gov remains |
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| June 7, 2023 |
Entry into a Material Definitive Agreement, Financial Statements and Exhibits, Other Events UNITED STATES SECURITIES AND EXCHANGE COMMISSION WASHINGTON, D.C. 20549 FORM 8-K CURRENT REPORT Pursuant to Section 13 or 15(d) of the Securities Exchange Act of 1934 Date of Report (Date of earliest event reported): (June 6, 2023) DAY ONE BIOPHARMACEUTICALS, INC. (Exact name of registrant as specified in its charter) Delaware 001-40431 83-2415215 (State or other jurisdiction of incorporation) (Co |
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| June 7, 2023 |
Day One Announces Pricing of Public Offering of Common Stock EX-99.1 Exhibit 99.1 Day One Announces Pricing of Public Offering of Common Stock BRISBANE, Calif., June 6, 2023 (GLOBE NEWSWIRE) – Day One Biopharmaceuticals, Inc. (Nasdaq: DAWN), a clinical-stage biopharmaceutical company dedicated to developing and commercializing targeted therapies for people of all ages with life-threatening diseases, today announced the pricing of its underwritten public off |
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| June 6, 2023 |
424B5 Table of Contents Filed Pursuant to Rule 424(b)(5) Registration No. 333-265346 The information in this preliminary prospectus supplement is not complete and may be changed. This preliminary prospectus supplement and the accompanying prospectus are part of an effective registration statement filed with the Securities and Exchange Commission. This preliminary prospectus supplement and the acco |
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| June 6, 2023 |
UNITED STATES SECURITIES AND EXCHANGE COMMISSION WASHINGTON, D.C. 20549 FORM 8-K CURRENT REPORT Pursuant to Section 13 or 15(d) of the Securities Exchange Act of 1934 Date of Report (Date of earliest event reported): (June 6, 2023) DAY ONE BIOPHARMACEUTICALS, INC. (Exact name of registrant as specified in its charter) Delaware 001-40431 83-2415215 (State or other jurisdiction of incorporation) (Co |
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| June 5, 2023 |
EX-99.1 Exhibit 99.1 Day One Biopharmaceuticals Targeted Therapies for People of All Ages June 2023 Day One Biopharmaceuticals Disclaimer This presentation and the accompanying oral commentary contain forward-looking statements that are based on our management’s beliefs and assumptions and on information currently available to our management. Forward-looking statements are inherently subject to ri |
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| June 5, 2023 |
UNITED STATES SECURITIES AND EXCHANGE COMMISSION WASHINGTON, D.C. 20549 FORM 8-K CURRENT REPORT Pursuant to Section 13 or 15(d) of the Securities Exchange Act of 1934 Date of Report (Date of earliest event reported): June 4, 2023 Month DAY ONE BIOPHARMACEUTICALS, INC. (Exact name of registrant as specified in its charter) Delaware 001-40431 83-2415215 (State or other jurisdiction of incorporation) |
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| June 5, 2023 |
EX-99.2 3 d643062dex992.htm EX-99.2 Exhibit 99.2 Day One Announces New FIREFLY-1 Data for Tovorafenib (DAY101) and Initiation of Rolling NDA Submission to FDA for Relapsed or Progressive Pediatric Low-Grade Glioma Overall response rate (ORR) of 67% and clinical benefit rate (CBR) of 93% in 69 heavily pretreated RANO-HGG evaluable patients The Company expects to complete rolling NDA submission in O |
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| May 1, 2023 |
UNITED STATES SECURITIES AND EXCHANGE COMMISSION WASHINGTON, D.C. 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, 2023 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: 001-40431 DAY ONE B |
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| May 1, 2023 |
Exhibit 99.1 Day One Reports First Quarter 2023 Financial Results and Corporate Progress FIREFLY-1 clinical abstract selected for oral presentation at the 2023 American Society of Clinical Oncology (ASCO) Annual Meeting Leadership team strengthened with executive appointments in clinical development and commercialization Pre-New Drug Application (NDA) meeting held April 19, 2023 with U.S. Food and |
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| May 1, 2023 |
Day One Biopharmaceuticals Day One Biopharmaceuticals Targeted Therapies for People of All Ages May 2023 Disclaimer This presentation and the accompanying oral commentary contain forward-looking statements that are based on our management’s beliefs and assumptions and on information currently available to our management. |
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| May 1, 2023 |
UNITED STATES SECURITIES AND EXCHANGE COMMISSION WASHINGTON, D.C. 20549 FORM 8-K CURRENT REPORT Pursuant to Section 13 or 15(d) of the Securities Exchange Act of 1934 Date of Report (Date of earliest event reported): May 01, 2023 DAY ONE BIOPHARMACEUTICALS, INC. (Exact name of registrant as specified in its charter) Delaware 001-40431 83-2415215 (State or other jurisdiction of incorporation) (Comm |
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| April 28, 2023 |
l UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 FORM 10-K (Mark One) ցց ANNUAL REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the fiscal year ended December 31, 2022 OR տտ 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 001-40431 DAY ONE BIO |
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| April 28, 2023 |
UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 SCHEDULE 14A Proxy Statement Pursuant to Section 14(a) of the Securities Exchange Act of 1934 Filed by the Registrant ☒ Filed by a Party other than the Registrant ☐ Check the appropriate box: ☐ Preliminary Proxy Statement ☐ Confidential, for Use of the Commission Only (as permitted by Rule 14a-6(e)(2)) ☐ Definitive Proxy St |
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| April 28, 2023 |
Definitive Proxy Statement on Schedule 14A TABLE OF CONTENTS UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D. |
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| April 20, 2023 |
UNITED STATES SECURITIES AND EXCHANGE COMMISSION WASHINGTON, D.C. 20549 FORM 8-K CURRENT REPORT Pursuant to Section 13 or 15(d) of the Securities Exchange Act of 1934 Date of Report (Date of earliest event reported): (April 20, 2023) DAY ONE BIOPHARMACEUTICALS, INC. (Exact name of registrant as specified in its charter) Delaware 001-40431 83-2415215 (State or other jurisdiction of incorporation) ( |
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| April 20, 2023 |
EX-99.1 Exhibit 99.1 Clinical activity of the type II pan-RAF inhibitor tovorafenib in BRAF-fusion melanoma Jeeyun Lee, MD,1 Natraj R. Ammakkanavar, MD,2 Aprajita Saini, MS,3 Mark W. Kieran MD, PhD,3 Lisa M. Kopp, DO, MPH,3 Bert H. O’Neil, MD2 1Samsung Medical Center, Sungkyunkwan University School of Medicine, Seoul, Republic of Korea; 2Community North Cancer Center, Indianapolis, IN, United Stat |
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| April 18, 2023 |
PRE 14A 1 ny20007645x1pre14a.htm PRE 14A TABLE OF CONTENTS UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 SCHEDULE 14A PROXY STATEMENT PURSUANT TO SECTION 14(A) OF THE SECURITIES EXCHANGE ACT OF 1934 Filed by the Registrant ☒ Filed by a Party other than the Registrant ☐ Check the appropriate box: ☒ Preliminary Proxy Statement ☐ Confidential, for Use of the Commission O |
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| March 20, 2023 |
EX-99.1 Exhibit 99.1 Day One Biopharmaceuticals Targeted Therapies for People of All Ages March 2023 Day One Biopharmaceuticals 1 Disclaimer This presentation and the accompanying oral commentary contain forward-looking statements that are based on our management’s beliefs and assumptions and on information currently available to our management. Forward-looking statements are inherently subject to |
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| March 20, 2023 |
Regulation FD Disclosure, Financial Statements and Exhibits UNITED STATES SECURITIES AND EXCHANGE COMMISSION WASHINGTON, D.C. 20549 FORM 8-K CURRENT REPORT Pursuant to Section 13 or 15(d) of the Securities Exchange Act of 1934 Date of Report (Date of earliest event reported): (March 20, 2023) DAY ONE BIOPHARMACEUTICALS, INC. (Exact name of registrant as specified in its charter) Delaware 001-40431 83-2415215 (State or other jurisdiction of incorporation) ( |
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| March 6, 2023 |
UNITED STATES SECURITIES AND EXCHANGE COMMISSION WASHINGTON, D.C. 20549 FORM 8-K CURRENT REPORT Pursuant to Section 13 or 15(d) of the Securities Exchange Act of 1934 Date of Report (Date of earliest event reported): March 06, 2023 DAY ONE BIOPHARMACEUTICALS, INC. (Exact name of registrant as specified in its charter) Delaware 001-40431 83-2415215 (State or other jurisdiction of incorporation) (Co |
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| March 6, 2023 |
Subsidiaries of the Registrant Exhibit 21.1 Subsidiaries of Day One Biopharmaceuticals, Inc. None. |
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| March 6, 2023 |
l 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, 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 001-40431 DAY ONE BIOPH |
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| March 6, 2023 |
Exhibit 99.1 Day One Reports Fourth Quarter and Full Year 2022 Financial Results and Corporate Progress First patient dosed in pivotal Phase 3 FIREFLY-2/LOGGIC trial evaluating tovorafenib (DAY101) as a frontline therapy for patients newly diagnosed with pediatric low-grade glioma (pLGG) Reported topline data in January 2023 from ongoing, pivotal Phase 2 FIREFLY-1 trial demonstrating meaningful re |
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| March 6, 2023 |
Day One Biopharmaceuticals Day One Biopharmaceuticals Targeted Therapies for People of All Ages March 2023 Disclaimer This presentation and the accompanying oral commentary contain forward-looking statements that are based on our management’s beliefs and assumptions and on information currently available to our management. |
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| February 23, 2023 |
UNITED STATES SECURITIES AND EXCHANGE COMMISSION WASHINGTON, D.C. 20549 FORM 8-K CURRENT REPORT Pursuant to Section 13 or 15(d) of the Securities Exchange Act of 1934 Date of Report (Date of earliest event reported): (February 17, 2023) DAY ONE BIOPHARMACEUTICALS, INC. (Exact name of registrant as specified in its charter) Delaware 001-40431 83-2415215 (State or other jurisdiction of incorporation |
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| February 23, 2023 |
Amended and Restated Bylaws, dated February 17, 2023. Exhibit 3.1 DAY ONE BIOPHARMACEUTICALS, INC. (a Delaware corporation) AMENDED AND RESTATED BYLAWS As Amended and Restated on February 17, 2023 TABLE OF CONTENTS Page Article I STOCKHOLDERS 1 Section 1.1. Annual Meetings 1 Section 1.2. Special Meetings 1 Section 1.3. Notice of Meetings 1 Section 1.4. Adjournments 1 Section 1.5. Quorum 2 Section 1.6. Organization 2 Section 1.7. Voting; Proxies 2 Sec |
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| February 14, 2023 |
DAWN / Day One Biopharmaceuticals, Inc. / RA CAPITAL MANAGEMENT, L.P. - SC 13G/A Passive Investment SC 13G/A 1 tm236221d26sc13ga.htm SC 13G/A UNITED STATES SECURITIES AND EXCHANGE COMMISSION WASHINGTON, D.C. 20549 SCHEDULE 13G/A Under the Securities Exchange Act of 1934 (Amendment No. 1 )* Day One Biopharmaceuticals, Inc. (Name of Issuer) Common Stock, par value $0.0001 per share (Title of Class of Securities) 23954D109 (CUSIP Number) December 31, 2022 (Date of Event Which Requires Filing of thi |