Expanded pipeline with DAY301, potential first-in-class Antibody Drug Conjugate (ADC) targeting PTK7 Entered into a definitive agreement for an oversubscribed private placement of its securities for total gross proceeds of approximately $175 million BRISBANE, Calif., July 30, 2024 (GLOBE NEWSWIRE) -- Day One Biopharmaceuticals, Inc. (Nasdaq: DAWN) ("Day One" or the "Company"), a biopharmaceutical company dedicated to developing and commercializing targeted therapies for people of all ages with life-threaten ...

Entered into a definitive agreement for an oversubscribed private placement of its securities for total gross proceeds of approximately $175 million Expanded pipeline with DAY301, potential first-in-class Antibody Drug Conjugate (ADC) targeting PTK7 About Day One Biopharmaceuticals Day One Biopharmaceuticals believes when it comes to pediatric cancer, we can do better. The Company was founded to address a critical unmet need: the dire lack of therapeutic development in pediatric cancer. Inspired by "The Day ...

The private placement includes participation from both new and existing investors including Fairmount, Braidwell LP, Deerfield Management, Wellington Management, Frazier Life Sciences and Access Biotechnology, as well as large investment management firms and several healthcare dedicated funds. J.P. Morgan, TD Cowen, Goldman Sachs & Co. LLC and Piper Sandler are acting as joint placement agents for the private placement. About Day One Biopharmaceuticals Day One is based in Brisbane, California. Forward-looki ...

Core Viewpoint - Day One Biopharmaceuticals has announced an oversubscribed private placement of securities, raising approximately $175 million to support its commercial and research initiatives [1][4]. Group 1: Private Placement Details - The private placement consists of 10,551,718 shares of common stock priced at $14.50 per share, along with 1,517,241 pre-funded warrants sold at $14.4999 each [3]. - The transaction is expected to close on August 1, 2024, pending customary closing conditions [4]. - Major investors include Fairmount, Braidwell LP, Deerfield Management, Wellington Management, Frazier Life Sciences, and Access Biotechnology [2]. Group 2: Use of Proceeds - Proceeds from the private placement will be utilized for enhancing commercial capabilities, ongoing research and development, potential strategic acquisitions or licensing, working capital, and general corporate purposes [4]. Group 3: Company Overview - Day One Biopharmaceuticals focuses on developing targeted therapies for pediatric cancer, addressing a significant unmet need in therapeutic development for this demographic [8]. - The company collaborates with clinical oncologists, families, and scientists to develop important cancer treatments, with a pipeline that includes tovorafenib (OJEMDA™), DAY301, and a VRK1 inhibitor program [9].

Day One Biopharmaceuticals (DAWN) signed an exclusive licensing agreement with MabCare Therapeutics for exclusive worldwide rights to develop, manufacture and commercialize the latter's investigational candidate, MTX-13 (now DAY301), for solid tumor indications. Shares of the company gained 11.3% on Jun 18, in response to the encouraging news. It is important to note that the investigational new drug application for DAY301 received FDA clearance in April 2024 based on positive results from its pre-clinical ...

Core Insights - The U.S. FDA has cleared the IND application for MTX-13, now known as DAY301, which has demonstrated antitumor activity in various solid tumors during pre-clinical studies [1][8] - DAY301 targets PTK7, a protein overexpressed in multiple adult and pediatric cancers, making it a promising therapeutic target due to its limited expression in normal tissues [2][8] - Day One Biopharmaceuticals has entered an exclusive licensing agreement with MabCare Therapeutics for the development and commercialization of DAY301, with potential milestone payments totaling $1.207 billion [3][8] Company Overview - Day One Biopharmaceuticals is focused on developing targeted therapies for life-threatening diseases, particularly in pediatric cancer, addressing a significant unmet need in therapeutic development [4][8] - The company aims to redefine cancer drug development and improve outcomes for patients of all ages, collaborating with clinical oncologists and families [4][9] - The pipeline includes other treatments such as tovorafenib (OJEMDA™) and pimasertib, with plans to expand through in-licensing clinical-stage assets [9] Financial Aspects - Under the licensing agreement, Day One will receive an upfront payment of $55 million and is eligible for up to $1.152 billion in additional milestone payments, along with royalties on net sales outside Greater China [3][8] - The company expects to begin dosing the first patient in the Phase I study of DAY301 in late 2024 or early 2025 [3][8]

"The sale of the PRV delivers true non-dilutive capital to Day One and further strengthens our balance sheet as we continue executing on the launch of OJEMDA and investing in clinical development opportunities for children and adults living with cancer," said Charles York II, chief operating and financial officer of Day One. Under the Rare Pediatric Disease Priority Review Voucher Program, FDA awards PRVs to sponsors of rare pediatric disease product applications that meet certain criteria. The program is i ...

BRISBANE, Calif., May 30, 2024 (GLOBE NEWSWIRE) -- 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 (PRV) for $108 million to an undisclosed buyer. The Company was awarded the PRV following the U.S. Food and Drug Administration (FDA) accelerated approval of OJEMDA™ (tovoraf ...

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 BIOPHARMACEUTICALS, INC. (Exact Name of Registrant as Specified in its Charter) Delaware 83-2415215 (State or oth ...

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-stage biopharmaceutical company dedicated to developing and commercializing targeted therapies for people of all ...