Day One Reports First Quarter 2025 Financial Results and Corporate Progress

On May 6, 2025 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, reported its first quarter 2025 financial results and highlighted recent corporate achievements (Press release, Day One, MAY 6, 2025, View Source [SID1234652572]).

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"We continued our successful launch of OJEMDA in 2025 and are energized by the growing impact we are bringing to patients every day," said Jeremy Bender, Ph.D., chief executive officer of Day One. "This is an exciting time of growth for Day One. We remain focused on creating value at every level of the organization, and we are executing on our objectives with urgency and fiscal discipline."

Program Highlights


OJEMDA net product revenue was $30.5 million in the first quarter of 2025.
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U.S. OJEMDA net product revenue increased 11% from the fourth quarter of 2024.
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OJEMDA prescriptions increased to over 900 (+16%) in the first quarter of 2025.


Achieved $87.7 million in OJEMDA net product revenue since launch, representing over 2,500 OJEMDA prescriptions.


In April 2025, Ipsen announced the regulatory filing for tovorafenib was accepted by the European Medicines Agency for review in the European Union, marking an important step forward for tovorafenib’s development outside of the U.S.


DAY301, our PTK7-targeted ADC, cleared the first dose cohort (a single-patient accelerated titration cohort) in the Phase 1a portion of the Phase 1a/b clinical trial.


Day One’s pivotal Phase 3 FIREFLY-2 clinical trial is expected to be fully enrolled in the first half of 2026.


Day One presented two posters at the 2025 American Association for Cancer Research (AACR) (Free AACR Whitepaper) annual meeting in Chicago, April 25-30, 2025.

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A preclinical study provided evidence for the efficacy of sequencing of MEK inhibitor treatment after tovorafenib by demonstrating mice bearing AGK::BRAF fusion tumors maintained significant tumor regression with no emergent tumors when treated with tovorafenib (25 mg/kg) once daily followed by MEK inhibitor treatment. Additionally, long-term efficacy was maintained with continuous dosing of tovorafenib in vivo; significant tumor regression was maintained with no emergent tumors indicating no evidence of emerging resistance. The study results demonstrate that anti-tumor activity with MEK inhibitors is observed after treatment with tovorafenib and suggest that acquired resistance may be less common in BRAF fusion-driven tumors treated with tovorafenib. (Abstract 1727: Sequencing MEK inhibitor therapy after tovorafenib in BRAF fusion-driven cancers: Preclinical evidence of sustained tumor regression)
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A clinical trial-in-progress poster on DAY301-001 the first-in-human Phase 1a/1b trial with DAY301 to evaluate its safety, tolerability, pharmacokinetics (PK) and antitumor activity in patients with locally advanced or metastatic solid tumors. (Abstract CT196: Phase I dose escalation and expansion study of the PTK-7 targeted antibody-drug conjugate DAY301 in patients with locally advanced or metastatic solid tumors)

First Quarter 2025 Financial Highlights


Product Revenue, Net: OJEMDA net product revenue was $30.5 million for the first quarter of 2025.


License Revenue: License revenue from the sale of ex-U.S. commercial rights for tovorafenib was $0.3 million for the first quarter of 2025.


R&D Expenses: Research and development expenses were $39.6 million for the first quarter of 2025 compared to $40.2 million for the first quarter of 2024. The difference was primarily due to a decrease in license agreement payments and employee compensation costs.


SG&A Expenses: Selling, general and administrative expenses were $29.3 million for the first quarter of 2025 compared to $26.6 million for the first quarter of 2024. The increase was primarily due to employee compensation costs and professional service expenses to support the launch of OJEMDA.


Net Loss: Net loss totaled $36.0 million for the first quarter of 2025 with non-cash stock-based compensation expense of $12.9 million, compared to a net loss of $62.4 million for the first quarter of 2024, with non-cash stock-based compensation expense of $12.6 million.


Cash Position: The Company’s cash, cash equivalents and short-term investments totaled $473.0 million as of March 31, 2025.

Upcoming Events


Bank of America Securities 2025 Health Care Conference
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Management will participate in a fireside chat on Tuesday, May 13 at 8:00 a.m. PT. A live and archived audio webcast of the discussion will be available by visiting the Events section of the Company’s website.


Society for Neuro-Oncology’s 8th Biennial Pediatric Neuro-Oncology Conference, May 15-17, 2025
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A poster sponsored by Day One, "Managing side effects of MAPK inhibitor therapies in pediatric populations: a Delphi consensus initiative," will be presented on May 16 at 6:15 p.m. PT.


2025 American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) Annual Meeting, May 30-June 3, 2025
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Abstract #10029 titled "Growth recovery in patients with BRAF altered pediatric low-grade gliomas (LGG) after discontinuation of tovorafenib" will be presented in a poster session on Saturday, May 31 from 9:00-12:00 p.m. CDT in Hall A.
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Abstract #10037 titled "Post hoc analysis of rashes reported in patients (pts) with BRAF-altered relapsed/refractory (r/r) pediatric low-grade glioma (pLGG) treated with the type II RAF inhibitor tovorafenib in FIREFLY-1" will be presented in a poster session on Saturday, May 31 from 9:00-12:00 p.m. CDT in Hall A.


46th Annual Goldman Sachs Global Healthcare Conference
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Management will participate in a fireside chat on Tuesday, June 10 at 8:40 a.m. ET. A live and archived audio webcast of the discussion will be available by visiting the Events section of the Company’s website.

Conference Call

Day One will host a conference call and webcast today, May 6 at 4:30 p.m. ET. To access the live conference call by phone, dial 877-704-4453 (domestic) or 201-389-0920 (international), and provide the access code 13745150. Live audio webcast will be accessible from the Day One Media & Investors page. To ensure a timely connection to the webcast, it is recommended that participants register at least 15 minutes prior to the scheduled start time. An archived version of the webcast will be available for replay on the Events section of the Day One Investors & Media page for 30 days following the event.

About OJEMDA

OJEMDA (tovorafenib) is a Type II RAF kinase inhibitor of mutant BRAF V600, wild-type BRAF, and wild-type CRAF kinases.

OJEMDA is indicated for the treatment of patients 6 months of age and older with relapsed or refractory pediatric low-grade glioma (LGG) harboring a BRAF fusion or rearrangement, or BRAF V600 mutation. This indication is approved under accelerated approval based on response rate and duration of response. Continued approval for this indication may be contingent upon verification and description of clinical benefit in a confirmatory trial(s).

Tovorafenib was granted Breakthrough Therapy and Rare Pediatric Disease designations by the FDA for the treatment of patients with pLGG harboring an activating RAF alteration, and it was evaluated by the FDA under priority review. Tovorafenib has also received Orphan Drug designation from the FDA for the treatment of malignant glioma and from the European Commission for the treatment of glioma.

For more information, please visit www.ojemda.com.