BRISBANE, Calif., Dec. 16, 2025 (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-threatening diseases, today announced that Dr. Jeremy Bender, chief executive officer, will present during the 44th Annual J.P. Morgan Healthcare Conference on Monday, January 12 at 5:15 p.m. Pacific Time / 8:15 p.m. Eastern Time. A live audio webcast of the ...

Company Overview - Day One Biopharmaceuticals, Inc. is focused on developing and commercializing targeted therapies for life-threatening diseases, particularly in pediatric cancer [3][4] - The company aims to address the critical unmet need in pediatric cancer therapeutic development, inspired by the initial conversations between physicians and families regarding cancer diagnosis and treatment [3] Upcoming Events - Management will participate in a fireside chat at the Piper Sandler 37th Annual Healthcare Conference on December 2, 2025, at 4:00 p.m. EST [1] - A live webcast of the discussion will be available on the company's Media & Investors page, with an archived replay accessible for 30 days post-event [2] Pipeline and Partnerships - Day One's pipeline includes targeted cancer treatments such as tovorafenib (OJEMDA™) and DAY301 [4] - The company collaborates with leading clinical oncologists, families, and scientists to identify and develop important cancer treatments [4] Communication Channels - Day One utilizes its Investor Relations website, X handle, and LinkedIn page to disseminate news, announcements, and financial performance updates [5]

Group 1 - Day One Biopharmaceuticals (NASDAQ:DAWN) has agreed to acquire Mersana Therapeutics Inc. (NASDAQ:MRSN), a clinical-stage biopharmaceutical company focused on antibody-drug conjugates (ADCs) targeting cancers [1][2] - The acquisition deal includes an upfront payment of $25.00 per share in cash, with potential additional payments under contingent value rights, leading to a total equity value of approximately $129 million and a total deal value of up to roughly $285 million [2] - Day One is focused on pediatric cancers and has a pipeline that includes tovorafenib (Ojemda) and DAY301 [2] Group 2 - In Q3, Ojemda's net product revenue reached $38.5 million, up from $20.1 million year-over-year, driven by increased patient demand [3] - The company has raised its full-year 2025 net product revenue guidance for Ojemda to between $145 million and $150 million, indicating continued strength in demand [3] - Quarterly prescriptions for Ojemda grew to 1,256 in Q3 2025, representing an 18% increase compared to Q2 2025 [3] Group 3 - Day One ended Q3 with $451.6 million in cash, cash equivalents, and short-term investments [4] - The acquisition of Mersana provides an opportunity to support the development of Emi-Le for patients with adenoid cystic carcinoma, addressing a high unmet need [4] - The Mersana board has unanimously approved the transaction, with closing expected by the end of January 2026 [5] Group 4 - Mersana Therapeutics shares increased by 206.82% to $27.21, while Day One Biopharmaceutical shares decreased by 5.78% to $9.74 at the time of publication [5]

Core Viewpoint - Mersana Therapeutics has entered into a definitive merger agreement with Day One Biopharmaceuticals, which includes an upfront cash consideration of $25.00 per share and potential contingent value rights cash payments of up to $30.25 per share, leading to a total deal value of approximately $285 million [2][4]. Company Overview - Mersana Therapeutics is a clinical-stage biopharmaceutical company focused on developing antibody-drug conjugates (ADCs) for cancer treatment, with a pipeline that includes Emi-Le, a Dolasynthen ADC targeting B7-H4 [6]. - Day One Biopharmaceuticals is a commercial-stage biopharmaceutical company dedicated to addressing unmet needs in pediatric cancer treatment [8]. Transaction Details - The merger will be executed through a tender offer followed by a second-step merger, with the tender offer required to commence within 10 business days of November 12, 2025 [3]. - The transaction has been unanimously approved by Mersana's board of directors, and closing is expected by the end of January 2026 [4]. - Mersana's executive officers and certain stockholders, holding approximately 8.5% of Mersana's outstanding shares, have signed agreements to support the tender offer [4]. Strategic Implications - The acquisition is expected to enhance the development of Emi-Le for treating patients with adenoid cystic carcinoma, a group with significant unmet medical needs [3]. - The combination of Mersana's assets and Day One's capabilities is anticipated to accelerate the delivery of new therapies to patients [3].

Core Business Performance - Day One Biopharmaceuticals reported a net product revenue of $38.5 million for OJEMDA in Q3 2025, marking a 15% increase from Q2 2025 and an 89% increase year-to-date compared to FY 2024 [7][13] - The total U.S. OJEMDA net product revenue for 2025 year-to-date reached $102.6 million [7] - Quarterly prescriptions (TRx) for OJEMDA grew to 1,256 in Q3 2025, representing an 18% increase compared to Q2 2025 [7] - New patient starts increased by 19% in Q3 2025, driven by data from the FIREFLY-1 clinical trial [7] Financial Highlights - The company raised its full-year 2025 net product revenue guidance for OJEMDA to between $145 million and $150 million, reflecting strong underlying demand [7] - Research and development expenses for Q3 2025 were $31.4 million, a decrease from $33.6 million in Q3 2024 [13] - Selling, general and administrative expenses were $28.1 million in Q3 2025, slightly down from $29.0 million in Q3 2024 [13] - The net loss for Q3 2025 was $19.7 million, compared to a net income of $37.0 million in Q3 2024 [13] Cash Position - As of September 30, 2025, the company had $451.6 million in cash, cash equivalents, and short-term investments [7][24] Corporate Developments - Heather Adkins Huet, PhD, joined Day One as Chief Scientific Officer in September 2025, bringing over two decades of experience in oncology therapeutics [5] - The company is progressing with the pivotal Phase 3 FIREFLY-2 clinical trial for first-line pediatric low-grade glioma (pLGG), with enrollment completion expected in the first half of 2026 [7] Upcoming Events - Three-year data from the FIREFLY-1 trial will be presented at the Society for Neuro-Oncology on November 23, 2025 [7]

Company Overview - Day One Biopharmaceuticals is focused on developing and commercializing targeted therapies for life-threatening diseases, particularly in pediatric cancer [3][4] - The company aims to address the critical unmet need in pediatric cancer therapeutic development, inspired by the initial conversations between physicians and families regarding cancer diagnosis and treatment [3] Upcoming Events - Day One will host a live conference call and webcast on November 4, 2025, at 4:30 p.m. ET to report its financial results and discuss corporate progress for Q3 2025 [1] - The live audio of the webcast will be accessible on the company's Media & Investors page, with an archived version available for replay for 30 days post-event [2] Pipeline and Partnerships - Day One's pipeline includes targeted cancer treatments such as tovorafenib (OJEMDA™) and DAY301 [4] - The company collaborates with leading clinical oncologists, families, and scientists to identify, acquire, and develop important cancer treatments [4]

Core Insights - Day One Biopharmaceuticals reported a net product revenue of $33.6 million for OJEMDA in Q2 2025, marking a 10% increase from Q1 2025 and a 310% increase from Q2 2024 [1][5][12] - The company expects full-year 2025 net product revenue to be between $140 million and $150 million [1][5] - Day One ended Q2 2025 with $453.1 million in cash, cash equivalents, and short-term investments [1][12] OJEMDA Commercial Performance - OJEMDA prescriptions exceeded 1,000 in Q2 2025, representing a 15% increase from Q1 2025 and a 346% increase from Q2 2024 [5] - The total net product revenue for OJEMDA for the 12-month period ending June 30, 2025, was $113.1 million [5] Financial Highlights - Research and development expenses for Q2 2025 were $36.1 million, down from $92.1 million in Q2 2024, primarily due to a one-time upfront payment in the previous year [12] - Selling, general, and administrative expenses decreased to $29.0 million in Q2 2025 from $30.2 million in Q2 2024 [12] - The net loss for Q2 2025 was $30.3 million, compared to a net loss of $4.4 million in Q2 2024 [12] Corporate Developments - Michael Vasconcelles, M.D., joined Day One as Head of Research and Development in June 2025, bringing over 25 years of oncology research experience [6] - The company terminated its research collaboration and license agreement with Sprint Bioscience AB to align with its strategic objectives [5] Clinical Trials and Pipeline - DAY301, a PTK7-targeted ADC, is currently enrolling patients in the Phase 1a portion of its clinical trial [5] - Day One plans to present 3-year follow-up data from the FIREFLY-1 clinical trial in Q4 2025 [5] - Patient enrollment for the pivotal Phase 3 FIREFLY-2 clinical trial is on track for completion in the first half of 2026 [5]

Company Overview - Day One Biopharmaceuticals is focused on developing and commercializing targeted therapies for life-threatening diseases, particularly in pediatric cancer [3][4] - The company aims to address the critical unmet need in pediatric cancer therapeutic development, inspired by the initial conversations between physicians and families regarding cancer diagnosis and treatment [3] Upcoming Events - Day One will host a live conference call and webcast on August 5, 2025, at 4:30 p.m. ET to report its financial results and discuss corporate progress for the second quarter of 2025 [1] - The live audio of the webcast will be accessible on the company's Media & Investors page, with an archived version available for replay for 30 days following the event [2] Pipeline and Partnerships - The company's pipeline includes targeted cancer treatments such as tovorafenib (OJEMDA™) and DAY301 [4] - Day One collaborates with leading clinical oncologists, families, and scientists to identify, acquire, and develop important cancer treatments [4] Communication Channels - Day One utilizes its Investor Relations website, social media platforms, and other channels to disseminate news, announcements, and financial performance updates [5]

Core Insights - Day One Biopharmaceuticals has appointed Dr. Michael Vasconcelles as Head of Research & Development, bringing over 25 years of oncology expertise to the company [2][3][4] - Dr. Vasconcelles will play a crucial role in advancing the company's pipeline and supporting the growth of its lead product, OJEMDA [3][5] 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 [6][7] - The company aims to redefine cancer drug development and improve outcomes for patients of all ages from the moment of diagnosis [6] Leadership and Experience - Dr. Vasconcelles has a robust background in oncology research and development, having held leadership roles at ImmunoGen, Flatiron Health, Unum Therapeutics, and Takeda [4][5] - His previous experience includes transforming ImmunoGen into a global biotech enterprise and overseeing clinical development at Genzyme [4] Strategic Goals - The company is committed to expanding its pipeline of first- or best-in-class medicines, with a focus on delivering transformative therapies for children with cancer [3][5] - Dr. Vasconcelles' leadership is expected to enhance the company's medical and scientific strategies, driving growth and innovation [3][5]

Core Insights - Day One Biopharmaceuticals reported a 16% increase in OJEMDA™ (tovorafenib) prescriptions in Q1 2025 compared to Q4 2024, with net product revenue reaching $30.5 million [1][2] - The company ended Q1 2025 with $473.0 million in cash, cash equivalents, and short-term investments [1][5] - Day One is focused on executing its objectives with urgency and fiscal discipline, aiming to create value at every organizational level [2] Financial Performance - OJEMDA net product revenue for Q1 2025 was $30.5 million, an 11% increase in U.S. revenue from Q4 2024 [2][5] - Total revenues for Q1 2025 were $30.8 million, with license revenue from ex-U.S. commercial rights amounting to $0.3 million [5][15] - Research and development expenses were $39.6 million, a slight decrease from $40.2 million in Q1 2024, while selling, general, and administrative expenses rose to $29.3 million from $26.6 million [5][15] - The net loss for Q1 2025 was $36.0 million, a reduction from a net loss of $62.4 million in Q1 2024 [5][15] Product Development and Regulatory Updates - Since its launch, OJEMDA has generated $87.7 million in net product revenue, with over 2,500 prescriptions [2] - The European Medicines Agency accepted the regulatory filing for tovorafenib in April 2025, marking a significant step for its development outside the U.S. [2] - The DAY301 clinical trial has cleared its first dose cohort in the Phase 1a portion, and the pivotal Phase 3 FIREFLY-2 trial is expected to be fully enrolled in the first half of 2026 [2] Upcoming Events - Day One will host a conference call and webcast on May 6, 2025, at 4:30 p.m. ET [1][4] - The company will participate in various upcoming conferences, including the Society for Neuro-Oncology's Pediatric Neuro-Oncology Conference and the ASCO Annual Meeting [4][5]