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 ...

Summary of Day One Biopharmaceuticals FY Conference Call Company Overview - **Company**: Day One Biopharmaceuticals (NasdaqGS:DAWN) - **Focus**: Developing new medicines for life-threatening diseases, particularly cancer, with an emphasis on pediatric patients [4][4] Key Products and Programs - **Ojemda**: - Approved in April 2024 for relapsed or refractory pediatric low-grade glioma (PLGG) - Exceeded initial expectations and has driven significant growth in 2024 and 2025 [4][4] - Aims to become the standard of care in the second-line treatment for PLGG patients with BRAF alterations [8][8] - **Day 301**: - A PTK7-targeted antibody-drug conjugate currently in phase 1A trial [5][5] - **Mersana Therapeutics Acquisition**: - Agreement to acquire Mersana for the MELE program, targeting adenoid cystic carcinoma (ACC), which has significant unmet medical needs [5][5] Market Insights and Learnings - **Ojemda Launch**: - The launch has been successful with extraordinary access and reimbursement for both on-label and off-label patients [10][10] - Physicians' experiences significantly influence treatment decisions due to the lack of rigorous clinical research in this area [13][13] - **Clinical Data**: - Follow-up data on Ojemda has shown promising results, with 77% of patients not requiring additional systemic therapy after 24 months of treatment [17][17] - The three-year data set is expected to address long-term efficacy and treatment duration questions [16][16] Future Growth Opportunities - **FIREFLY-2 Trial**: - Expected to complete enrollment in the first half of 2026, with data anticipated in mid-2027 [40][40] - **Day 301 Updates**: - Further data expected in 2026, with a focus on establishing expansion arms based on initial dose escalation results [48][48] - **Mersana Acquisition**: - Anticipated to close in early Q1 2026, with updates on the MELE program expected in the same year [42][42] Financial Considerations - **Investment in Mersana**: - Total investment for the registrational trial and associated costs is projected to be at or below $200 million, which aligns well with the company's size and potential opportunity [70][70] Strategic Direction - **Business Development**: - The company plans to remain active in business development to expand its pipeline, focusing on programs that fit strategically and can provide short-term value [74][74] Conclusion - Day One Biopharmaceuticals is positioned for growth with its innovative therapies targeting significant unmet needs in pediatric oncology, particularly through the successful launch of Ojemda and the strategic acquisition of Mersana Therapeutics. The company is focused on leveraging clinical data to enhance physician adoption and drive future growth.

Core Insights - The updated three-year results from the FIREFLY-1 trial demonstrate that 77% of patients who entered a treatment-free observation period after OJEMDA treatment remained off therapy for at least 12 months [1][5] - The median time to next treatment (TTNT) following the initiation of OJEMDA exceeded 3.5 years [1][5] - Tovorafenib shows potential as a second-line standard of care for pediatric low-grade glioma (pLGG) [3][4] Trial Results - In the FIREFLY-1 trial, 76 evaluable patients showed an overall response rate of 53% (40/76), with a median duration of response of 19.4 months [3][14] - The median time to response was 5.4 months, and the median progression-free survival was 16.6 months [3][5] - Among 39 patients who entered a treatment-free observation period, the median treatment-free interval was not reached, with minimal tumor rebound observed [5] Safety Profile - No new safety signals were identified in the updated analysis, with common grade 3 or higher adverse events including decreased growth velocity and anemia [6][14] - The most frequently reported adverse reactions (≥30%) included rash, fatigue, and viral infections [14][15] Regulatory Status - Tovorafenib (OJEMDA) is approved by the FDA for pediatric patients aged 6 months and older with relapsed or refractory pLGG harboring a BRAF fusion or rearrangement [7][8] - The drug has received Breakthrough Therapy and Rare Pediatric Disease designations from the FDA [10] Industry Context - Pediatric low-grade glioma is the most common brain tumor in children, with significant unmet medical needs due to the lack of approved treatments targeting BRAF alterations [11][12] - The FIREFLY-1 trial is part of a broader effort to evaluate tovorafenib in pediatric patients with pLGG, highlighting the importance of targeted therapies in this demographic [13][18]

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]

Core Viewpoint - Day One Biopharmaceuticals, Inc. (DAWN) has shown a significant price increase of 22.2% over the past four weeks, with a mean price target of $23 indicating a potential upside of 161.4% from its current price of $8.8 [1] Price Targets - The average price target consists of eight estimates ranging from a low of $16.00 to a high of $29.00, with a standard deviation of $4.93, indicating variability among analysts [2] - The lowest estimate suggests an increase of 81.8%, while the highest points to a 229.6% upside [2] - A low standard deviation indicates a higher agreement among analysts regarding the price movement direction [9] Analyst Sentiment - Analysts are optimistic about DAWN's earnings prospects, as evidenced by a trend of upward revisions in earnings estimates, which historically correlates with stock price movements [11] - Over the last 30 days, six earnings estimates have been revised higher, resulting in an 18.2% increase in the Zacks Consensus Estimate [12] Zacks Rank - DAWN holds a Zacks Rank 2 (Buy), placing it in the top 20% of over 4,000 ranked stocks based on earnings estimate factors, suggesting strong potential for near-term upside [13] Conclusion on Price Targets - While the consensus price target may not be a reliable measure of the extent of potential gains, it does provide a useful indication of the expected direction of price movement [14]

Core Viewpoint - Day One Biopharmaceuticals announced the acquisition of Mersana Therapeutics for $285 million, significantly impacting Mersana's stock price, which surged by 209.24% following the news [2]. Group 1: Acquisition Details - The acquisition allows Day One to enhance its oncology portfolio by adding Emi-Le, a potential first-line monotherapy for patients with adenoid cystic carcinoma (ACC), an aggressive cancer with unmet medical needs [4]. - The deal includes an immediate cash offer of $25 per share for Mersana's common stock, plus a non-tradable contingent value right (CVR) that could total up to $30.25 per share, bringing the total cash consideration to $55.25 per share, with an overall transaction value of approximately $285 million [7]. Group 2: Product and Market Potential - Emi-Le is a B7-H4-directed antibody-drug conjugate (ADC) that shows measurable anti-tumor activity in patients with ACC, which is characterized by high expression of B7-H4 [3][4]. - The drug is positioned for accelerated clinical development due to its innovative design and the clear patient population it targets, which currently lacks approved therapeutic options [4][6]. Group 3: Strategic Implications - The acquisition is expected to create significant growth and value opportunities for Day One, leveraging its existing R&D expertise and commercial capabilities to address rare and life-threatening cancers across all age groups [6].

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]

Summary of Day One Biopharmaceuticals Conference Call Company and Industry Overview - **Company**: Day One Biopharmaceuticals (NasdaqGS:DAWN) - **Acquisition Target**: Mersana Therapeutics - **Industry**: Biopharmaceuticals, specifically focused on oncology and rare cancers Key Points and Arguments 1. **Acquisition Announcement**: Day One Biopharmaceuticals announced the acquisition of Mersana Therapeutics to expand its pipeline and create a new growth catalyst targeting life-threatening diseases [1][11] 2. **Strategic Fit**: The acquisition is seen as a strong strategic fit, particularly with Mersana's advanced program, Emyle, which targets adenoid cystic carcinoma (ACC) [1][3] 3. **Emyle Overview**: Emyle is a dolostatin antibody-drug conjugate targeting B7-H4, showing early potential as a monotherapy for ACC, a rare cancer with no approved targeted therapies [2][6] 4. **Patient Population**: Approximately 1,300 new cases of ACC are diagnosed annually in the U.S., with a significant unmet need for effective treatments [2][5] 5. **Clinical Data**: Early phase I data showed a 55.6% objective response rate in a subset of patients with ACC, indicating promising antitumor activity [7][8] 6. **Safety Profile**: Emyle demonstrated a manageable safety profile with low-grade adverse events, which is crucial for its development [8][9] 7. **Regulatory Pathway**: Day One plans to discuss potential paths to approval for Emyle with regulators, aiming for accelerated approval in aggressive forms of ACC [3][10] 8. **Financial Details**: The acquisition will cost $129 million in cash, with additional contingent payments based on clinical and regulatory milestones. The transaction is expected to close by January 2026 [11][12] 9. **Cash Position**: Day One reported a strong cash position of $451.6 million with no debt, allowing for the acquisition to be funded entirely from existing resources [12][13] 10. **Future Development**: The company is focused on advancing Emyle with urgency and scientific rigor, leveraging its experience from previous successful product registrations [10][19] Additional Important Insights 1. **Broader Patient Population**: There is potential to expand the target patient population beyond ACC-1, which is a specific aggressive subtype of ACC [3][27] 2. **Ongoing Trials**: Mersana's ongoing dose optimization cohorts are expected to provide further insights into Emyle's efficacy and safety [18][65] 3. **Partnerships**: Existing partnerships with Johnson & Johnson and Merck KGaA will continue post-acquisition, ensuring continuity in Mersana's collaborations [44][45] 4. **Long-term Strategy**: Day One aims to build a diversified pipeline with both near-term and long-term value creation opportunities, focusing on unmet medical needs in oncology [30][32] This summary encapsulates the critical aspects of Day One Biopharmaceuticals' conference call regarding its acquisition of Mersana Therapeutics and the potential impact on the oncology landscape, particularly for patients with adenoid cystic carcinoma.

Acquisition of Mersana Therapeutics N O V E M B E R 2 0 2 5 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 Q&A Session All Participants 2 Confidential Information. For internal use only. Forward Looking Statements This communication contains forward-looking statements. Forward-looking statements are generally identified by the words "expects", "anticipates", "believes", "intends", ...

Core Viewpoint - Day One Biopharmaceuticals has announced a definitive merger agreement to acquire Mersana Therapeutics, which will enhance its oncology portfolio with the addition of Emi-Le, a novel antibody-drug conjugate showing early anti-tumor activity in a Phase 1 study for adenoid cystic carcinoma [1][2][3] Group 1: Acquisition Details - The acquisition will involve a tender offer to acquire Mersana's outstanding shares at a price of $25 per share in cash, plus potential milestone payments totaling up to $30.25 per share, leading to a total consideration of up to $55.25 per share [4] - The total equity value of the deal is approximately $129 million at closing, with a total deal value of up to approximately $285 million [4] - The transaction is expected to close by the end of January 2026, pending regulatory approvals and other customary conditions [8] Group 2: Product and Market Potential - Emi-Le is positioned as a potential first-in-class monotherapy for patients with adenoid cystic carcinoma, a cancer with high unmet medical need, particularly in the salivary gland [2] - The drug targets B7-H4, a well-characterized target in certain cancers, and has shown early anti-tumor activity in its ongoing Phase 1 study [2] - The company believes that Emi-Le's innovative profile and the lack of approved therapies for its target population provide a clear path for rapid development and commercialization [2][3] Group 3: Financial and Strategic Implications - Day One plans to finance the acquisition using existing cash resources, indicating a strong financial position that supports the development of Emi-Le without the need for additional financing [6] - The acquisition is expected to broaden Day One's opportunities for patient impact and growth, leveraging existing research and development expertise [3]