Day One Reports Second Quarter 2025 Financial Results and Corporate Progress
Day One Biopharmaceuticals (NASDAQ:DAWN) reported strong Q2 2025 financial results, with OJEMDA net product revenue of $33.6 million, representing a 310% increase year-over-year and 10% quarter-over-quarter growth. The company provided full-year 2025 OJEMDA revenue guidance of $140-150 million.
Key highlights include OJEMDA prescriptions exceeding 1,000 in Q2 2025 (up 346% YoY), appointment of Dr. Michael Vasconcelles as Head of R&D, and continued progress in clinical trials. The company ended Q2 with $453.1 million in cash and reported a net loss of $30.3 million. R&D expenses decreased to $36.1 million from $92.1 million in Q2 2024, primarily due to prior year's MabCare license payment.
Day One Biopharmaceuticals (NASDAQ:DAWN) ha riportato risultati finanziari solidi per il secondo trimestre del 2025, con un fatturato netto da OJEMDA di 33,6 milioni di dollari, che rappresenta un aumento del 310% su base annua e una crescita del 10% rispetto al trimestre precedente. L'azienda ha fornito una previsione di fatturato per OJEMDA per l'intero 2025 compresa tra 140 e 150 milioni di dollari.
I punti salienti includono oltre 1.000 prescrizioni di OJEMDA nel secondo trimestre 2025 (in aumento del 346% su base annua), la nomina del Dr. Michael Vasconcelles come Responsabile R&S, e continui progressi negli studi clinici. L'azienda ha chiuso il secondo trimestre con 453,1 milioni di dollari in liquidità e ha registrato una perdita netta di 30,3 milioni di dollari. Le spese per R&S sono diminuite a 36,1 milioni di dollari rispetto ai 92,1 milioni del secondo trimestre 2024, principalmente a causa del pagamento della licenza MabCare dell'anno precedente.
Day One Biopharmaceuticals (NASDAQ:DAWN) reportó sólidos resultados financieros en el segundo trimestre de 2025, con un ingreso neto por producto OJEMDA de 33,6 millones de dólares, lo que representa un aumento del 310% interanual y un crecimiento del 10% respecto al trimestre anterior. La compañía proporcionó una guía de ingresos para OJEMDA en todo 2025 de 140 a 150 millones de dólares.
Los aspectos destacados incluyen más de 1,000 prescripciones de OJEMDA en el segundo trimestre de 2025 (un aumento del 346% interanual), el nombramiento del Dr. Michael Vasconcelles como Jefe de I+D, y avances continuos en los ensayos clínicos. La compañía finalizó el segundo trimestre con 453,1 millones de dólares en efectivo y reportó una pérdida neta de 30,3 millones de dólares. Los gastos en I+D disminuyeron a 36,1 millones desde 92,1 millones en el segundo trimestre de 2024, principalmente debido al pago de la licencia MabCare del año anterior.
Day One Biopharmaceuticals (NASDAQ:DAWN)는 2025년 2분기에 강력한 재무 실적을 보고했으며, OJEMDA 순제품 매출액은 3,360만 달러로 전년 동기 대비 310%, 전분기 대비 10% 성장했습니다. 회사는 2025년 전체 OJEMDA 매출 가이던스를 1억 4천만~1억 5천만 달러로 제시했습니다.
주요 내용으로는 2025년 2분기 OJEMDA 처방 건수가 1,000건을 초과(전년 대비 346% 증가), Dr. Michael Vasconcelles가 연구개발 책임자로 임명된 점, 임상 시험에서 지속적인 진전이 포함됩니다. 회사는 2분기 말 현금 보유액이 4억 5,310만 달러였으며 순손실은 3,030만 달러를 기록했습니다. 연구개발 비용은 전년 동기 9,210만 달러에서 3,610만 달러로 감소했는데, 이는 주로 전년도 MabCare 라이선스 비용 때문입니다.
Day One Biopharmaceuticals (NASDAQ:DAWN) a annoncé de solides résultats financiers pour le deuxième trimestre 2025, avec un chiffre d'affaires net produit d'OJEMDA de 33,6 millions de dollars, soit une augmentation de 310 % en glissement annuel et une croissance de 10 % par rapport au trimestre précédent. La société a fourni des prévisions de revenus pour OJEMDA sur l'ensemble de l'année 2025 comprises entre 140 et 150 millions de dollars.
Les points clés incluent plus de 1 000 prescriptions d'OJEMDA au deuxième trimestre 2025 (en hausse de 346 % en glissement annuel), la nomination du Dr Michael Vasconcelles au poste de responsable R&D, ainsi que des progrès continus dans les essais cliniques. La société a terminé le deuxième trimestre avec 453,1 millions de dollars en trésorerie et a enregistré une perte nette de 30,3 millions de dollars. Les dépenses de R&D ont diminué à 36,1 millions de dollars contre 92,1 millions au deuxième trimestre 2024, principalement en raison du paiement de la licence MabCare l'année précédente.
Day One Biopharmaceuticals (NASDAQ:DAWN) meldete starke Finanzergebnisse für das zweite Quartal 2025 mit einem Netto-Umsatz von OJEMDA in Höhe von 33,6 Millionen US-Dollar, was einem Anstieg von 310 % im Jahresvergleich und einem Wachstum von 10 % im Quartalsvergleich entspricht. Das Unternehmen gab eine Umsatzprognose für OJEMDA für das Gesamtjahr 2025 von 140 bis 150 Millionen US-Dollar bekannt.
Wichtige Highlights sind über 1.000 OJEMDA-Verschreibungen im zweiten Quartal 2025 (plus 346 % im Jahresvergleich), die Ernennung von Dr. Michael Vasconcelles zum Leiter der F&E sowie anhaltende Fortschritte in klinischen Studien. Das Unternehmen schloss das zweite Quartal mit 453,1 Millionen US-Dollar in bar ab und meldete einen Nettoverlust von 30,3 Millionen US-Dollar. Die F&E-Ausgaben sanken auf 36,1 Millionen US-Dollar von 92,1 Millionen US-Dollar im zweiten Quartal 2024, hauptsächlich aufgrund der MabCare-Lizenzzahlung im Vorjahr.
- None.
- Net loss of $30.3 million in Q2 2025
- Terminated research collaboration with Sprint Bioscience AB
- Quarter-over-quarter OJEMDA revenue growth slowed to 10%
Insights
Day One reports strong 10% QoQ OJEMDA revenue growth to $33.6M with solid cash position of $453.1M, supporting positive business momentum.
Day One Biopharmaceuticals' Q2 2025 results demonstrate impressive commercial traction for their lead product OJEMDA (tovorafenib). With
The company's financial foundation appears solid with
R&D expenses decreased substantially year-over-year from
While the company reported a net loss of
The company's three-pronged strategy focusing on OJEMDA revenue growth, pipeline advancement, and disciplined portfolio expansion provides a clear roadmap for future growth. The addition of Dr. Michael Vasconceles as Head of R&D brings valuable oncology development expertise that should strengthen their clinical execution capabilities.
OJEMDA™ (tovorafenib) net product revenue of
OJEMDA full-year 2025 net product revenue expected to be
Ended the second quarter with
Company to host conference call and webcast today, August 5, 4:30 p.m. ET
BRISBANE, Calif., Aug. 05, 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 its second quarter 2025 financial results and highlighted recent corporate achievements.
“We have strong momentum going into the second half of 2025. We continue to focus on our three core priorities: accelerating revenue growth with OJEMDA, advancing our pipeline, and pursuing value-driving portfolio expansion anchored in financial discipline,” said Jeremy Bender, Ph.D., chief executive officer of Day One. “With strong execution across the organization and a solid financial foundation, we’re building a company that aims to deliver meaningful value to patients and to shareholders.”
OJEMDA Commercial Performance
- OJEMDA net product revenue was
$33.6 million in the second quarter of 2025, an increase of310% from the second quarter of 2024. - U.S. OJEMDA net product revenue increased
10% from the first quarter of 2025. - OJEMDA prescriptions exceeded 1,000 in the second quarter of 2025, representing a
15% increase compared to the first quarter of 2025 and a346% increase compared to the second quarter of 2024. - Achieved
$113.1 million in OJEMDA net product revenue for the most recent 12-month period ended June 30, 2025. - The Company is providing 2025 net product revenue guidance of
$140 t o$150 million .
Program Highlights
- DAY301, the Company’s PTK7-targeted ADC, is actively enrolling patients in the Phase 1a portion of the Phase 1a/b clinical trial; the trial is progressing as planned.
- Day One expects to present 3-year follow-up data from the FIREFLY-1 clinical trial in the fourth quarter of 2025.
- Day One published additional data characterizing growth velocity recovery and effective rash management at the 2025 American Society of Clinical Oncology Annual Meeting.
- Abstract 10029: Growth recovery in patients with BRAF-altered pediatric low-grade gliomas (pLGGs) after discontinuation of tovorafenib
- Abstract 10037: Post hoc analysis of rashes reported in patients with BRAF-altered relapsed/refractory pediatric low-grade glioma treated with the type II RAF inhibitor tovorafenib in FIREFLY-1
- Abstract 10029: Growth recovery in patients with BRAF-altered pediatric low-grade gliomas (pLGGs) after discontinuation of tovorafenib
- Patient enrollment in the pivotal Phase 3 FIREFLY-2 clinical trial is on track to achieve completion of trial enrollment in the first half of 2026.
- Day One terminated its research collaboration and license agreement with Sprint Bioscience AB following careful consideration of the current development status for the VRK1 program and the Company’s overall strategic objectives.
Corporate Highlights
- Industry leader Michael Vasconcelles, M.D., joined Day One in June 2025 as Head of Research and Development. Dr. Vasconcelles brings more than 25 years of extensive oncology research and development experience to the Company, most recently as Executive Vice President and Head of Research, Development and Medical Affairs at ImmunoGen.
Second Quarter 2025 Financial Highlights
- Product Revenue, Net: OJEMDA net product revenue was
$33.6 million for the second quarter of 2025 compared to$8.2 million for the second quarter of 2024. - License Revenue: License revenue from the sale of ex-U.S. commercial rights for tovorafenib was
$0.3 million for the second quarter of 2025. - R&D Expenses: Research and development expenses were
$36.1 million for the second quarter of 2025 compared to$92.1 million for the second quarter of 2024. The decrease was primarily due to the MabCare Therapeutics license agreement upfront payment of$55.0 million in the second quarter of 2024. - SG&A Expenses: Selling, general and administrative expenses were
$29.0 million for the second quarter of 2025 compared to$30.2 million for the second quarter of 2024. The decrease was primarily due to lower employee compensation costs. - Net Loss: Net loss totaled
$30.3 million for the second quarter of 2025 with non-cash stock-based compensation expense of$10.9 million , compared to a net loss of$4.4 million for the second quarter of 2024, with non-cash stock-based compensation expense of$13.0 million and gain from sale of priority voucher of$108.0 million . - Cash Position: The Company’s cash, cash equivalents and short-term investments totaled
$453.1 million as of June 30, 2025.
Conference Call
Day One will host a conference call and webcast today, August 5 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.
About Day One Biopharmaceuticals
Day One Biopharmaceuticals believes when it comes to pediatric cancer, we can do better. The Company was founded to address a critical unmet need: the dire lack of therapeutic development in pediatric cancer. Inspired by “The Day One Talk” that physicians have with patients and their families about an initial cancer diagnosis and treatment plan, Day One aims to re-envision cancer drug development and redefine what’s possible for all people living with cancer—regardless of age—starting from day one.
Day One partners with leading clinical oncologists, families, and scientists to identify, acquire, and develop important targeted cancer treatments. The Company’s pipeline includes tovorafenib (OJEMDA™) and DAY301.
Day One is based in Brisbane, California. For more information, please visit www.dayonebio.com or find the Company on LinkedIn or X.
Day One uses its Investor Relations website (ir.dayonebio.com), its X handle (x.com/DayOneBio), and LinkedIn Home Page (linkedin.com/company/dayonebio) as a means of disseminating or providing notification of, among other things, news or announcements regarding its business or financial performance, investor events, press releases, and earnings releases, and as a means of disclosing material nonpublic information and for complying with its disclosure obligations under Regulation FD.
Cautionary Note Regarding Forward-Looking Statements
This press release contains “forward-looking” statements within the meaning of the “safe harbor” provisions of the Private Securities Litigation Reform Act of 1995, including, but not limited to: Day One’s plans to develop and commercialize cancer therapies, expectations from current and planned clinical trials, the execution of the Phase 2 and Phase 3 clinical trial for tovorafenib as designed, expectations with respect to the timing of Day One’s Phase 1a/b clinical trial of DAY301, any expectations about safety, efficacy, timing and ability to complete clinical trials, release data results and to obtain regulatory approvals for tovorafenib and other candidates in development, and the ability of tovorafenib to treat pLGG or related indications.
Statements including words such as “believe,” “plan,” “continue,” “expect,” “will,” “develop,” “signal,” “potential,” or “ongoing” and statements in the future tense are forward-looking statements. These forward-looking statements involve risks and uncertainties, as well as assumptions, which, if they do not fully materialize or prove incorrect, could cause our results to differ materially from those expressed or implied by such forward-looking statements.
Forward-looking statements are subject to risks and uncertainties that may cause Day One’s actual activities or results to differ significantly from those expressed in any forward-looking statement, including risks and uncertainties in this press release and other risks set forth in our filings with the Securities and Exchange Commission, including Day One’s ability to develop, obtain and retain regulatory approval for or commercialize any product candidate, Day One’s ability to protect intellectual property, the potential impact of global business or macroeconomic conditions, including as a result of inflation, changing interest rates, cybersecurity incidents, significant political or regulatory developments or changes in trade policy, including tariffs, shifting priorities within the U.S. Food and Drug Administration and reduced funding to federal healthcare programs, global regional conflicts and the sufficiency of Day One’s cash, cash equivalents and investments to fund its operations. These forward-looking statements speak only as of the date hereof and Day One specifically disclaims any obligation to update these forward-looking statements or reasons why actual results might differ, whether as a result of new information, future events or otherwise, except as required by law.
| Day One Biopharmaceuticals, Inc. Condensed Statements of Operations (in thousands, except share and per share amounts) (unaudited) | ||||||||||||||||
| Three Months Ended June 30, | Six Months Ended June 30, | |||||||||||||||
| 2025 | 2024 | 2025 | 2024 | |||||||||||||
| Revenue: | ||||||||||||||||
| Product revenue, net | $ | 33,562 | $ | 8,192 | $ | 64,065 | $ | 8,192 | ||||||||
| License revenue | 346 | — | 604 | — | ||||||||||||
| Total revenues | 33,908 | 8,192 | 64,669 | 8,192 | ||||||||||||
| Cost and operating expenses: | ||||||||||||||||
| Cost of product and license revenue | 3,765 | 707 | 6,649 | 707 | ||||||||||||
| Research and development | 36,149 | 92,106 | 75,768 | 132,316 | ||||||||||||
| Selling, general and administrative | 28,968 | 30,186 | 58,293 | 56,743 | ||||||||||||
| Total cost and operating expenses | 68,882 | 122,999 | 140,710 | 189,766 | ||||||||||||
| Loss from operations | (34,974 | ) | (114,807 | ) | (76,041 | ) | (181,574 | ) | ||||||||
| Non-operating income: | ||||||||||||||||
| Gain from sale of priority review voucher | — | 108,000 | — | 108,000 | ||||||||||||
| Investment income, net | 4,671 | 3,962 | 9,765 | 8,327 | ||||||||||||
| Other expense, net | (19 | ) | (10 | ) | (42 | ) | (20 | ) | ||||||||
| Total non-operating income, net | 4,652 | 111,952 | 9,723 | 116,307 | ||||||||||||
| Loss before income taxes | (30,322 | ) | (2,855 | ) | (66,318 | ) | (65,267 | ) | ||||||||
| Income tax expense | — | (1,552 | ) | — | (1,552 | ) | ||||||||||
| Net loss | (30,322 | ) | (4,407 | ) | (66,318 | ) | (66,819 | ) | ||||||||
| Net loss per share - basic | $ | (0.29 | ) | $ | (0.05 | ) | $ | (0.64 | ) | $ | (0.77 | ) | ||||
| Net loss per share - diluted | $ | (0.29 | ) | $ | (0.05 | ) | $ | (0.64 | ) | $ | (0.77 | ) | ||||
| Weighted-average number of common shares used in net loss per share - basic | 103,069,154 | 87,121,310 | 102,890,506 | 86,864,545 | ||||||||||||
| Weighted-average number of common shares used in net loss per share - diluted | 103,069,154 | 87,121,310 | 102,890,506 | 86,864,545 | ||||||||||||
| Day One Biopharmaceuticals, Inc. Selected Condensed Balance Sheets Data (in thousands) (unaudited) | ||||||||
| June 30, 2025 | December 31, 2024 | |||||||
| Cash, cash equivalents and short-term investments | $ | 453,103 | $ | 531,720 | ||||
| Total assets | 519,037 | 582,788 | ||||||
| Total liabilities | 58,203 | 80,037 | ||||||
| Accumulated deficit | (620,399 | ) | (554,081 | ) | ||||
| Total stockholders’ equity | 460,834 | 502,751 | ||||||
DAY ONE MEDIA
Laura Cooper, Head of Communications
media@dayonebio.com
DAY ONE INVESTORS
LifeSci Advisors, PJ Kelleher
pkelleher@lifesciadvisors.com
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