Day One Reports Third Quarter 2025 Financial Results and Corporate Progress
Day One (Nasdaq: DAWN) reported third quarter 2025 results with accelerating commercial performance of OJEMDA and strengthened financial position. Q3 OJEMDA net product revenue was $38.5M, up 15% sequentially; YTD U.S. OJEMDA revenue was $102.6M, +89% versus 2024. Quarterly TRx reached 1,256 and new patient starts rose 19% sequentially. The company raised full-year 2025 OJEMDA revenue guidance to $145–$150M. R&D spend was $31.4M and SG&A $28.1M in Q3; net loss was $19.7M. Cash, cash equivalents and short-term investments totaled $451.6M as of Sep 30, 2025. Three-year FIREFLY-1 data will be presented Nov 23, 2025.
Day One (Nasdaq: DAWN) ha riportato i risultati del terzo trimestre 2025 con una prestazione commerciale accelerata di OJEMDA e una posizione finanziaria rafforzata. Q3 OJEMDA net product revenue è stato di 38,5 M$, +15% su base sequenziale; YTD U.S. OJEMDA i ricavi sono stati di 102,6 M$, +89% rispetto al 2024. Il TRx trimestrale ha raggiunto 1.256 e i nuovi avviamenti di pazienti sono aumentati del 19% rispetto al trimestre precedente. L’azienda ha innalzato la guidance dei ricavi per OJEMDA per l’intero 2025 a $145–$150M. La spesa in R&D è stata di 31,4 M$ e SG&A di 28,1 M$ nel Q3; la perdita netta è stata di 19,7 M$. Le disponibilità liquide, equivalenti di cassa e investimenti a breve termine ammontavano a $451,6M al 30 set 2025. Verranno presentati i dati FIREFLY-1 triennali il 23 nov 2025.
Day One (Nasdaq: DAWN) informó resultados del tercer trimestre de 2025 con un desempeño comercial acelerado de OJEMDA y una posición financiera fortalecida. Q3 OJEMDA net product revenue fue de 38,5 M$, (+15% secuencial); YTD U.S. OJEMDA ingresos fue de 102,6 M$, +89% frente a 2024. Las ventas TRx del trimestre alcanzaron 1.256 y los nuevos pacientes iniciados aumentaron un 19% secuencialmente. La compañía elevó la guía de ingresos para OJEMDA para todo 2025 a $145–$150M. El gasto en I+D fue de 31,4 M$ y SG&A 28,1 M$ en el 3T; la pérdida neta fue de 19,7 M$. El efectivo, equivalentes de efectivo y inversiones a corto plazo sumaron $451,6M al 30 de sep de 2025. Se presentarán datos de FIREFLY-1 de tres años el 23 de nov de 2025.
Day One (Nasdaq: DAWN)은 2025년 3분기 실적을 발표했고 OJEMDA의 상업적 성과가 가속화되었으며 재무 상태가 강화되었습니다. Q3 OJEMDA net product revenue은 3,850만 달러로 전년 대비 15% 증가; YTD U.S. OJEMDA 매출은 1억 2,260만 달러로 2024년 대비 89% 증가했습니다. 분기당 TRx은 1,256에 도달했고 신규 환자 시작도 전분기 대비 19% 증가했습니다. 회사는 2025년 전체 OJEMDA 매출 가이던스를 $145–$150M으로 상향했습니다. R&D 지출은 3분기에 3140만 달러, SG&A는 2810만 달러였습니다. 순손실은 1970만 달러였습니다. 현금 및 현금성자산, 단기투자총액은 2025년 9월 30일 기준 $451.6M이었습니다. 3년간 FIREFLY-1 데이터는 2025년 11월 23일에 발표될 예정입니다.
Day One (Nasdaq: DAWN) a publié ses résultats du troisième trimestre 2025 avec une performance commerciale d’OJEMDA qui s’accélère et une position financière renforcée. Q3 OJEMDA net product revenue a été de 38,5 M$, en hausse de 15 % en glissement trimestriel ; YTD U.S. OJEMDA les revenus ont atteint 102,6 M$, +89 % par rapport à 2024. Le TRx trimestriel a atteint 1 256 et les nouveaux démarrages de patients ont augmenté de 19 % en glissement trimestriel. La société a relevé la prévision de revenus pour OJEMDA pour l’ensemble de 2025 à $145–$150M. Les dépenses de R&D s’élevaient à 31,4 M$ et les SG&A à 28,1 M$ au T3 ; la perte nette était de 19,7 M$. La trésorerie, les équivalents de trésorerie et les investissements à court terme totalisaient $451,6M au 30 sept. 2025. Les données FIREFLY-1 sur trois ans seront présentées le 23 nov. 2025.
Day One (Nasdaq: DAWN) hat die Ergebnisse des dritten Quartals 2025 bekannt gegeben, mit beschleunigter kommerzieller Performance von OJEMDA und gestärkter finanzieller Position. Q3 OJEMDA net product revenue betrug 38,5 Mio. $, +15 % gegenüber dem Vorquartal; YTD U.S. OJEMDA Umsatz betrug 102,6 Mio. $, +89 % gegenüber 2024. Das Quartals-TRx erreichte 1.256 und neue Patienteneinweisungen stiegen gegenüber dem Vorquartal um 19 %. Das Unternehmen hob die Umsatzguidance für OJEMDA für das Gesamtjahr 2025 auf $145–$150M an. Die F&E-Ausgaben lagen bei 31,4 Mio. $, und SG&A bei 28,1 Mio. $ im Q3; der Nettom Verlust betrug 19,7 Mio. $. Barbestände, Äquivalente und kurzfristige Investitionen beliefen sich am 30. Sep 2025 auf insgesamt $451,6M. Drei-Jahres-FIREFLY-1-Daten werden am 23. Nov. 2025 vorgestellt.
Day One (Nasdaq: DAWN) ذكرت نتائج الربع الثالث من عام 2025 مع أداء تجاري متسارع لـ OJEMDA ووضع مالي قوي. Q3 OJEMDA net product revenue كان 38.5 مليون دولار، بزيادة 15% على أساس ربع سنوي؛ YTD U.S. OJEMDA الإيرادات الأمريكية حتى تاريخه بلغت 102.6 مليون دولار، بزيادة 89% مقارنة بعام 2024. وصل TRx الفصلي إلى 1,256 وزادت بدايات المرضى الجدد بنسبة 19% على أساس ربع سنوي. رفعت الشركة توجيهات الإيرادات لـ OJEMDA للسنة الكاملة 2025 إلى $145–$150M. إنفاق البحث والتطوير كان 31.4 مليون دولار وSG&A 28.1 مليون دولار في الربع الثالث؛ الخسارة الصافية بلغت 19.7 مليون دولار. المبالغ النقدية ومرادف النقد والاستثمارات قصيرة الأجل بلغت الإجمالي $451.6M حتى 30 سبتمبر 2025. ستُعرض بيانات FIREFLY-1 لمدة ثلاث سنوات في 23 نوفمبر 2025.
- OJEMDA Q3 revenue $38.5M (+15% QoQ)
- YTD U.S. OJEMDA $102.6M (+89% vs 2024)
- Raised 2025 guidance to $145–$150M
- Cash position $451.6M as of Sep 30, 2025
- TRx 1,256 in Q3 (+18% QoQ)
- Net loss $19.7M in Q3 2025
- License revenue dropped to $1.3M in Q3 2025 from $73.7M prior-year
- R&D expense $31.4M in Q3 (ongoing clinical costs)
Insights
Strong commercial momentum: accelerating OJEMDA sales, raised 2025 guidance, and a robust cash position support positive outlook.
OJEMDA delivered
These figures show improving uptake and prescribing confidence. The company raised full-year OJEMDA guidance to
Key dependencies remain enrollment in the Phase 3 FIREFLY-2 trial, expected to complete enrollment in the first half of
Monitor quarterly OJEMDA revenue and TRx trends, the FIREFLY-1 three-year oral presentation on
Commercial execution delivers best quarter launch-to-date with growth across all dimensions of core business
Raising OJEMDA full-year 2025 net product revenue guidance to
Three-year FIREFLY-1 data to be released in oral presentation at Society for Neuro-Oncology on Nov. 23, 2025
Ended the third quarter with
Company to host conference call and webcast today, November 4, 4:30 p.m. Eastern Time
BRISBANE, Calif., Nov. 04, 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 third quarter 2025 financial results and highlighted recent corporate achievements.
“Our third quarter results reflect acceleration across every key dimension of OJEMDA’s performance and growing confidence among prescribers as we continue to build the case for second-line standard-of-care through execution and additional data readouts,” said Jeremy Bender, Ph.D., chief executive officer of Day One. “Combined with steady pipeline progress, we are well positioned to deliver sustainable growth for shareholders while we continue our mission to bring meaningful therapies to patients.”
OJEMDA™ Commercial Performance
- OJEMDA net product revenue was
$38.5 million in the third quarter of 2025, an increase of15% from the second quarter of 2025. - Achieved
$102.6 million in U.S. OJEMDA net product revenue for 2025 year-to-date through the third quarter of 2025, representing an89% increase over fiscal year 2024. - Quarterly prescriptions (TRx) grew to 1,256 in the third quarter of 2025, representing an
18% increase compared to the second quarter of 2025. - Third quarter new patient starts grew
19% compared to the second quarter of 2025, driven by the FIREFLY-1 clinical trial 2-year follow-up data. - The Company is raising the OJEMDA full-year 2025 net product revenue guidance to
$145 t o$150 million , reflecting continued strength in underlying demand.
Program Highlights
- Progressing enrollment in the pivotal Phase 3 FIREFLY-2 clinical trial in first-line pediatric low-grade glioma (pLGG), with enrollment completion anticipated in the first half of 2026.
- Advancing dose escalation in the Phase 1a clinical trial of DAY301, a PTK7-targeted antibody drug conjugate (ADC).
- Tovorafenib added as a category 2a recommended therapy in the National Comprehensive Cancer Network (NCCN) treatment guidelines for adult patients with recurrent or progressive BRAF-altered glioma.
Corporate Highlights
- Seasoned biopharmaceutical executive Heather Adkins Huet, PhD, joined Day One in September 2025 as Chief Scientific Officer. Dr. Huet brings over two decades of experience leading and managing the full life cycle of oncology therapeutics, from discovery through life-cycle management of approved products, in biotech startup, mid-cap and large-cap companies including ImmunoGen, Takeda Pharmaceuticals, and Unum Therapeutics.
Third Quarter 2025 Financial Highlights
- Product Revenue, Net: OJEMDA net product revenue was
$38.5 million for the third quarter of 2025 compared to$20.1 million for the third quarter of 2024 driven by higher patient demand. - License Revenue: License revenue from the sale of ex-U.S. commercial rights for tovorafenib was
$1.3 million for the third quarter of 2025 compared to$73.7 million for the third quarter of 2024 during which period the upfront consideration received from Ipsen for the pLGG license rights of$73.5 million was recognized. - R&D Expenses: Research and development expenses were
$31.4 million for the third quarter of 2025 compared to$33.6 million for the third quarter of 2024. - SG&A Expenses: Selling, general and administrative expenses were
$28.1 million for the third quarter of 2025 compared to$29.0 million for the third quarter of 2024. - Net Loss: Net loss totaled
$19.7 million for the third quarter of 2025 with non-cash stock-based compensation expense of$9.6 million , compared to a net income of$37.0 million for the third quarter of 2024, with non-cash stock-based compensation expense of$11.6 million . - Cash Position: The Company’s cash, cash equivalents and short-term investments totaled
$451.6 million as of September 30, 2025.
Upcoming Events
- Three-year data from the pivotal FIREFLY-1 trial will be presented in an oral presentation titled ‘Clinical stability following tovorafenib treatment in relapsed/refractory pediatric low-grade glioma: updated results from the phase 2 FIREFLY-1 trial’ on Sunday, Nov. 23 at 11:49 a.m. HST during the 2025 Society for Neuro Oncology Annual Meeting.
- Piper Sandler 37th Annual Healthcare Conference, December 2-4, 2025.
Conference Call
Day One will host a conference call and webcast today, Nov. 4 at 4:30 p.m. Eastern Time. 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 Events 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 Media & Investors 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, government shutdowns, 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. Statements of Operations (unaudited) (in thousands, except share amounts) | |||||||||||||||
| Three Months Ended September 30, | Nine Months Ended September 30, | ||||||||||||||
| 2025 | 2024 | 2025 | 2024 | ||||||||||||
| Revenue: | |||||||||||||||
| Product revenue, net | $ | 38,522 | $ | 20,070 | $ | 102,587 | $ | 28,262 | |||||||
| License revenue | 1,273 | 73,691 | 1,877 | 73,691 | |||||||||||
| Total revenues | 39,795 | 93,761 | 104,464 | 101,953 | |||||||||||
| Cost and operating expenses: | |||||||||||||||
| Cost of product and license revenue | 4,480 | 1,590 | 11,129 | 2,297 | |||||||||||
| Research and development | 31,419 | 33,563 | 107,187 | 165,879 | |||||||||||
| Selling, general and administrative | 28,147 | 28,972 | 86,440 | 85,715 | |||||||||||
| Total cost and operating expenses | 64,046 | 64,125 | 204,756 | 253,891 | |||||||||||
| (Loss) income from operations | (24,251 | ) | 29,636 | (100,292 | ) | (151,938 | ) | ||||||||
| Non-operating income: | |||||||||||||||
| Gain from sale of priority review voucher | — | — | — | 108,000 | |||||||||||
| Investment income, net | 4,559 | 5,322 | 14,324 | 13,649 | |||||||||||
| Other (expense) income, net | (34 | ) | 1,197 | (76 | ) | 1,177 | |||||||||
| Total non-operating income, net | 4,525 | 6,519 | 14,248 | 122,826 | |||||||||||
| (Loss) income before income taxes | (19,726 | ) | 36,155 | (86,044 | ) | (29,112 | ) | ||||||||
| Income tax benefit (expense) | — | 882 | — | (670 | ) | ||||||||||
| Net (loss) income | (19,726 | ) | 37,037 | (86,044 | ) | (29,782 | ) | ||||||||
| Net (loss) income per share - basic | $ | (0.19 | ) | $ | 0.38 | $ | (0.83 | ) | $ | (0.33 | ) | ||||
| Net (loss) income per share - diluted | $ | (0.19 | ) | $ | 0.38 | $ | (0.83 | ) | $ | (0.33 | ) | ||||
| Weighted-average number of common shares used in net (loss) income per share - basic | 103,381,315 | 96,623,123 | 103,056,046 | 90,164,895 | |||||||||||
| Weighted-average number of common shares used in net (loss) income per share - diluted | 103,381,315 | 96,937,759 | 103,056,046 | 90,164,895 | |||||||||||
| Day One Biopharmaceuticals, Inc. Selected Balance Sheet Data (unaudited) (in thousands) | ||||||||
| September 30, 2025 | December 31, 2024 | |||||||
| Cash, cash equivalents and short-term investments | $ | 451,580 | $ | 531,720 | ||||
| Total assets | 513,780 | 582,788 | ||||||
| Total liabilities | 62,912 | 80,037 | ||||||
| Accumulated deficit | (640,125 | ) | (554,081 | ) | ||||
| Total stockholders’ equity | 450,868 | 502,751 | ||||||
DAY ONE MEDIA
Laura Cooper, Head of Communications
media@dayonebio.com
DAY ONE INVESTORS
LifeSci Advisors, PJ Kelleher
pkelleher@lifesciadvisors.com
FAQ
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