Business Development - XOMA Royalty has completed acquisitions of Turnstone Biologics and HilleVax, and announced acquisitions of LAVA Therapeutics and Mural Oncology [1][6] - The company acted as a structuring agent for XenoTherapeutics' acquisition of ESSA Pharma [1] Key Pipeline Advancements - Zevra Therapeutics submitted a Marketing Authorization Application (MAA) for arimoclomol to treat Niemann-Pick Type C [2] - Rezolute Bio expects to announce topline data in December from its Phase 3 ersodetug trial for congenital hyperinsulinism [2] - Gossamer Bio anticipates topline results from its Phase 3 trial of seralutunib in pulmonary atrial hypertension in February 2026 [2] Financial Performance - In the first nine months of 2025, XOMA Royalty received $43.9 million in royalties and milestones, with $14.3 million received in the third quarter [3][10] - Income for the three and nine months ended September 30, 2025, was $9.4 million and $38.4 million, respectively, compared to $7.2 million and $19.8 million for the same periods in 2024 [10] - Net income for the three and nine months ended September 30, 2025, was $14.1 million and $25.6 million, compared to net losses of $17.2 million and $9.9 million in the corresponding periods of 2024 [17] Cash Position - As of September 30, 2025, XOMA Royalty had cash and cash equivalents of $130.6 million, including $85.4 million in restricted cash [18][19] - The company received $14.3 million in cash receipts from royalties and commercial payments in the third quarter of 2025 [20] Acquisitions and Royalty Interests - XOMA Royalty will secure economic interests in partnered assets from LAVA Therapeutics, including PF-08046052 and JNJ-89853413 [5] - The acquisition of Mural Oncology is expected to close in the fourth quarter of 2025, with cash payments ranging from $2.035 to $2.24 per share [6] Research and Development Expenses - R&D expenses for the three and nine months ended September 30, 2025, were $69 thousand and $1.4 million, respectively [11] - The increase in R&D expenses in 2025 was primarily related to clinical trial costs following the acquisition of Kinnate [11] General and Administrative Expenses - G&A expenses for the three and nine months ended September 30, 2025, were $9.7 million and $25.7 million, respectively [12] - The increase in G&A expenses for the three months ended September 30, 2025, was due to higher business development costs [12]

Financial Performance - Net product revenue reached $38.5 million in Q3 2025[11], a 15% or $4.9 million increase compared to Q2 2025[11, 17] - The company is raising its 2025 net product revenue guidance to $145 million - $150 million[11, 29] - Year-to-date net product revenue for 2025 reached $102.6 million, exceeding the full-year 2024 revenue by approximately 89%[19] - The company has a strong financial position with $452 million in cash[11] OJEMDA Launch Performance - There was an 18% growth in total prescriptions, with 1,256 prescriptions (TRx) in Q3 2025[15] - New patient starts increased by 19%[15, 21] - Adoption of OJEMDA in the 2L setting grew by over 60% in the past 12 months[23] Pipeline Progress - Tovorafenib EMA regulatory decision is expected in 2026[11] - FIREFLY-2 trial enrollment completion is expected in the first half of 2026[11] - Three-year follow-up data from FIREFLY-1 will be presented at the SNO conference[11, 30]

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]

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]

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]