Day One Biopharmaceuticals, Inc. (DAWN) came out with a quarterly loss of $0.2 per share versus the Zacks Consensus Estimate of a loss of $0.17. This compares to a loss of $0.69 per share a year ago. These figures are adjusted for non-recurring items.This quarterly report represents an earnings surprise of -19.98%. A quarter ago, it was expected that this company would post a loss of $0.28 per share when it actually produced a loss of $0.19, delivering a surprise of +32.14%.Over the last four quarters, the ...

Day One Biopharmaceuticals (NasdaqGS:DAWN) Q4 2025 Earnings call February 24, 2026 04:30 PM ET Company ParticipantsBrittany Socha - Equity Research AssociateCharles N. York II - COO and CFOJeremy Bender - CEOJoey Perrone - Senior Vice President of Finance and Investor RelationsLauren Merendino - CCOMichael Vasconcelles - Head of Research and DevelopmentNick Lorusso - Equity Research Vice PresidentPoorna Kannan - Equity Research AssociateConference Call ParticipantsAndres Y. Maldonado - Senior Biotechnology ...

Day One Biopharmaceuticals (NasdaqGS:DAWN) Q4 2025 Earnings call February 24, 2026 04:30 PM ET Company ParticipantsBrittany Socha - Equity Research AssociateCharles N. York II - COO and CFOJeremy Bender - CEOJoey Perrone - Senior Vice President of Finance and Investor RelationsLauren Merendino - CCOMichael Vasconcelles - Head of Research and DevelopmentNick Lorusso - Equity Research Vice PresidentPoorna Kannan - Equity Research AssociateConference Call ParticipantsAndres Y. Maldonado - Senior Biotechnology ...

Day One Biopharmaceuticals (NasdaqGS:DAWN) Q4 2025 Earnings call February 24, 2026 04:30 PM ET Speaker8Hello, ladies and gentlemen, and welcome to the Day One Biopharmaceuticals's fourth quarter and full year 2025 financial and operating results conference call. 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 over to Joey Perrone, Senior Vice Presid ...

FEBRUARY 2026 Fourth Quarter & Full-Year 2025 Financial Results & Corporate Progress In addition, statements that "we believe" and similar statements reflect our beliefs and opinions on the relevant subject. These statements are based upon information available to us as of the date of this presentation, and although we believe such information forms a reasonable basis for such statements, such information may be limited or incomplete, and our statements should not be read to indicate that we have conducted ...

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 BIOPHARMACEUTICALS, INC. (Exact name of Registrant as specified in its Charter) Delaware 83-2415215 (State or other jur ...

Financial Performance - As of December 31, 2025, the company reported cash, cash equivalents, and short-term investments of $441.1 million[5]. - OJEMDA net revenue for Q3 2025 was $38.5 million, up from $20.1 million in Q3 2024, representing a 91.5% increase[42]. - Total revenue for the nine months ended September 30, 2025, was $104.5 million, compared to $102.0 million for the same period in 2024, showing a 2.5% increase[42]. - The company reported a net loss of $19.7 million for Q3 2025, compared to a net income of $37.0 million in Q3 2024[42]. - Research and Development expenses for the nine months ended September 30, 2025, were $107.2 million, down from $165.9 million in 2024, a decrease of 35.4%[42]. - Selling, General and Administrative expenses for the nine months ended September 30, 2025, were $86.4 million, slightly up from $85.7 million in 2024[42]. Product Development and Approval - OJEMDA received FDA approval in April 2024 for pediatric patients aged 6 months and older with specific BRAF alterations[4]. - The company plans to advance the Emi-Le program with a path toward registration and has acquired Mersana Therapeutics[5]. - The pivotal Phase 3 trial of tovorafenib in front-line pediatric low-grade glioma (pLGG) is expected to complete enrollment in 1H 2026, with topline data expected mid-2027[31]. - The company plans to complete FIREFLY-2 trial enrollment in the first half of 2026, enabling mid-2027 data readout and potential approval in 2028[43]. - The company anticipates delivering Phase 1 clinical data for Emi-Le by mid-2026 and progressing to later-stage development[43]. - DAY301 is a next-generation antibody-drug conjugate (ADC) targeting PTK7, with Phase 1a data expected in 2H 2026[37]. Market Opportunity and Growth - The company aims to solidify OJEMDA as the second-line standard of care (SOC) in relapsed or refractory pediatric low-grade glioma (pLGG) and expand its market opportunity[5]. - The company anticipates a revenue opportunity exceeding $1 billion across three high unmet need indications[7]. - The number of treatment decisions for relapsed or refractory pediatric low-grade glioma (pLGG) is approximately 1,100 annually, with significant room for market share growth for OJEMDA[14]. - OJEMDA's estimated net product revenues for Q4 2025 are projected to be $52.8 million, reflecting a 37% growth compared to Q3 2025 and a 172% increase from 2024[15]. - The expected net product revenue for OJEMDA in 2026 is estimated to be between $225 million and $250 million, indicating over 50% growth compared to 2025[16]. - OJEMDA has achieved a 60% increase in 2L adoption over the past 12 months, with a growing number of healthcare providers selecting it as their treatment of choice[17]. - The company anticipates a significant increase in prescribing accounts, with 28% sequential growth in accounts treating four or more patients[18]. - OJEMDA's commercial execution is expected to drive strong growth in 2026, supported by favorable payer dynamics and a solidified position as the second-line standard of care[16]. Clinical Data and Efficacy - OJEMDA's median duration of response is reported at 19.4 months, with 77% of patients treatment-free for at least 12 months following 24 months of therapy[12]. - 75% of patients in the Expanded Access Program (EAP) who reached 24 months on OJEMDA continued treatment, demonstrating strong persistency[17]. - The Phase 2 FIREFLY-1 trial reported a 53% overall response rate (ORR) among patients, with 58% completing 26 or more treatment cycles[23]. - Median tumor size change from baseline after the last dose was -51% at 3 months and -55% at 6 months post-treatment[26]. - All 8 patients receiving OJEMDA retreatment were still on therapy at the time of data cutoff, with a median change in tumor size of -38.3%[27]. - In the updated 3-year analysis, 38 patients had RAPNO-defined progressive disease (PD) while on OJEMDA[26]. - No new safety signals were observed in the 3-year update, with 66% of treatment-related adverse events (TRAEs) being grade ≥3[29]. - 77% of 39 patients were treatment-free for at least 12 months, with the median treatment-free interval not yet reached[28]. Intellectual Property - The patent portfolio for OJEMDA includes a composition of matter patent extending to mid-2036, with additional protections potentially extending into the 2040s[20]. Strategic Partnerships - The company is focused on global commercial expansion through partnerships, including a license agreement with Ipsen for OJEMDA outside the U.S.[6]. - The company aims to expand OJEMDA globally, extending its commercial opportunity through collaboration with Ipsen[43].

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 Phase 1 trial for adenoid cystic carcinoma (ACC) Day One to host conference call and webcast today, February 24, 4:30 p.m. ET BRISBANE, Calif., Feb. 24, 2026 (GLOBE NEWSWIRE) -- Day One Biopharmaceuticals, Inc. (Nasdaq: DAWN) (“Day One” or th ...

Core Viewpoint - Day One Biopharmaceuticals is set to report its financial results and corporate progress for Q4 and full-year 2025 on February 24, 2026, highlighting its commitment to developing targeted therapies for life-threatening diseases, particularly in pediatric cancer [1]. Group 1: Company Overview - Day One Biopharmaceuticals is a commercial-stage biopharmaceutical company focused on addressing the unmet needs in pediatric cancer treatment [3]. - The company aims to redefine cancer drug development and improve outcomes for patients of all ages from the moment of diagnosis [3]. Group 2: Pipeline and Development - Day One's pipeline includes tovorafenib (OJEMDA™), DAY301, and Emi-Le (emiltatug ledadotin), a novel antibody drug conjugate targeting the B7-H4 protein, currently in clinical development for adenoid cystic carcinoma (ACC) [4]. - The recent acquisition of Mersana Therapeutics enhances Day One's capabilities in developing targeted cancer treatments [4]. Group 3: Communication and Accessibility - A live conference call and webcast will be available for stakeholders to access financial results and corporate updates [2]. - An archived version of the webcast will be accessible for 30 days post-event, ensuring continued engagement with investors and the public [2].

Group 1 - Day One Biopharmaceuticals, Inc. (DAWN) closed at $11.16, reflecting a 26.1% gain over the past four weeks, with a mean price target of $22.44 indicating a potential upside of 101.1% [1] - The average price target ranges from a low of $16.00 to a high of $29.00, with a standard deviation of $4.59, suggesting a variability in analyst estimates [2] - Analysts have shown increasing optimism regarding DAWN's earnings prospects, as indicated by a positive trend in earnings estimate revisions, with a 20.6% increase in the Zacks Consensus Estimate for the current year [11][12] Group 2 - DAWN currently holds a Zacks Rank 2 (Buy), placing it in the top 20% of over 4,000 ranked stocks based on earnings estimates [13] - The clustering of price targets with a low standard deviation indicates a high degree of agreement among analysts about the stock's price movement direction [9] - While price targets should not be the sole basis for investment decisions, they can provide a useful guide for potential price movement [14]