Black Diamond Therapeutics Reports Third Quarter 2025 Financial Results and Provides Corporate Update
Black Diamond Therapeutics (Nasdaq: BDTX) reported Q3 2025 results and a corporate update on Nov 6, 2025. The company ended Q3 with $135.5 million in cash, cash equivalents and investments, which it expects will fund operations into Q4 2027. Black Diamond will disclose ORR and preliminary duration of treatment data later this quarter from all n=43 patients in its silevertinib Phase 2 frontline EGFRm NSCLC trial; PFS data is expected in H1 2026. Q3 operating metrics: net loss $8.5M, R&D $7.4M, G&A $3.5M, and net cash used in operations $7.9M for the quarter.
Black Diamond Therapeutics (Nasdaq: BDTX) ha comunicato i risultati del terzo trimestre 2025 e un aggiornamento aziendale il 6 novembre 2025. Al termine del Q3 la società aveva 135,5 milioni di dollari in cassa, contanti equivalenti e investimenti, cifra che prevede potrà sostenere l'operatività fino al Q4 2027. Black Diamond diffonderà dati su ORR e durata preliminare del trattamento provenienti da tutti i 43 pazienti nello studio di Fase 2 frontline EGFRm NSCLC con silevertinib, nel trimestre in corso; i dati sul PFS sono attesi nel 2026-primo semestre. Indicatori operativi del Q3: perdita netta di 8,5 milioni, R&D 7,4 milioni, G&A 3,5 milioni, e liquidità netta impiegata nelle operazioni di 7,9 milioni nel trimestre.
Black Diamond Therapeutics (Nasdaq: BDTX) informó resultados del tercer trimestre de 2025 y actualizó sobre la empresa el 6 de noviembre de 2025. Al cierre del Q3, la compañía contaba con 135,5 millones de dólares en efectivo, equivalentes de efectivo e inversiones, cifra que estima podrá financiar sus operaciones hasta el 4T 2027. Black Diamond revelará datos de ORR y duración preliminar del tratamiento de todos los 43 pacientes en su ensayo de Fase 2 de silevertinib en NSCLC EGFRm en la primera línea; se esperan datos de PFS en la 1.ª mitad de 2026. Métricas operativas del 3T: pérdida neta de 8,5 millones, I+D 7,4 millones, G&A 3,5 millones, y gasto neto de caja en operaciones de 7,9 millones para el trimestre.
Black Diamond Therapeutics (나스닥: BDTX)가 2025년 11월 6일 2025년 3분기 실적 발표와 기업 업데이트를 발표했습니다. 3분기 말 현금성 자산 및 투자 자산은 1억 3,550만 달러로, 이는 2027년 4분기까지 운영 자금을 뒷받침할 것으로 전망됩니다. Black Diamond은 이번 분기 중 silevertinib의 2상 1차 EGFRm NSCLC 전선 연구에서 ORR 및 치료 기간의 예비 데이터를 모든 43명의 환자에서 공개할 예정이며, PFS 데이터는 2026년 상반기에 발표될 것으로 보입니다. 3분기 운영 지표: 순손실 850만 달러, R&D 740만 달러, G&A 350만 달러, 분기 동안의 순 현금 사용액은 790만 달러였습니다.
Black Diamond Therapeutics (Nasdaq: BDTX) a publié les résultats du T3 2025 et une mise à jour de l’entreprise le 6 novembre 2025. À la fin du T3, la société disposait de 135,5 millions de dollars en trésorerie, équivalents de trésorerie et investissements, montant qu’elle prévoit pouvoir financer ses activités jusqu’au T4 2027. Black Diamond dévoilera des données sur le ORR et la durée préliminaire du traitement issues des 43 patients de l’étude de phase 2 en première ligne EGFRm NSCLC avec le silevertinib; les données de PFS sont attendues au premier semestre 2026. Indicateurs opérationnels du T3 : perte nette de 8,5 M$, R&D 7,4 M$, G&A 3,5 M$, et utilisation nette de la trésorerie dans les opérations de 7,9 M$ pour le trimestre.
Black Diamond Therapeutics (Nasdaq: BDTX) veröffentlichte am 6. November 2025 die Ergebnisse des Q3 2025 und ein Unternehmensupdate. Zum Ende des Q3 verfügte das Unternehmen über 135,5 Mio. USD an Bargeld, Zahlungsmitteläquivalente und Investitionen, von denen erwartet wird, dass sie die operative Tätigkeit bis ins Q4 2027 finanzieren. Black Diamond wird ORR und die vorläufige Behandlungsdauer aus allen 43 Patienten in seiner silevertinib Phase-2-Frontline EGFRm NSCLC-Studie im laufenden Quartal offenlegen; Daten zum PFS werden in der ersten Hälfte von 2026 erwartet. Q3-Betriebskennzahlen: Nettoloss 8,5 Mio. USD, F&E 7,4 Mio. USD, Verwaltung 3,5 Mio. USD, und Netto-Cash-Used in Operations 7,9 Mio. USD für das Quartal.
Black Diamond Therapeutics (ناسداك: BDTX) أصدرت نتائج الربع الثالث من 2025 وتحديثًا للشركة في 6 نوفمبر 2025. انتهى الربع الثالث بمقدار 135.5 مليون دولار من النقد والبدائل النقدية والاستثمارات، وهو ما تتوقع أن يغطي تشغيلاتها حتى الربع الرابع من 2027. ستعلن Black Diamond عن بيانات ORR ومدة العلاج الأولية من جميع المرضى 43 في تجربتها من المرحلة الثانية لعلاج NSCLC من EGFRm باستخدام silevertinib في الخط الأول خلال هذا الربع؛ ويتوقع بيانات PFS في النصف الأول من 2026. مقاييس التشغيل للربع الثالث: خسارة صافية قدرها 8.5 مليون دولار، البحث والتطوير 7.4 مليون دولار، الإدارة العامة 3.5 مليون دولار، والصافي النقدي المستخدم في العمليات 7.9 مليون دولار للربع.
- $135.5M cash and investments at Sept 30, 2025
- Cash runway expected into Q4 2027
- Planned ORR and duration data from n=43 silevertinib patients this quarter
- R&D spend reduced to $7.4M in Q3 2025
- Net loss of $8.5M in Q3 2025
- Net cash used in operations $7.9M in Q3 2025
- Outlicensing BDTX-4933 reduced internal pipeline breadth
Insights
Silevertinib Phase 2 ORR and preliminary duration data due this quarter; PFS expected in
Black Diamond plans to report objective response rate (ORR) and preliminary duration of treatment for all 43 frontline non-classical EGFRm NSCLC patients in the Phase 2 study. ORR and duration are direct, early indicators of clinical activity; these datasets will determine whether the program merits a registrational discussion with the FDA once PFS matures.
Key dependencies include the magnitude and durability of responses across the enrolled population and the representativeness of the n=43 cohort for a registrational claim. Heterogeneity in non-classical EGFR mutations could dilute pooled ORR; subgroup consistency will matter. Watch for the disclosed ORR percentage, median duration of treatment, and any safety signal this quarter, then PFS readout in
Cash runway extended to
Cash, cash equivalents, and investments totaled
This cash position and the stated belief it funds operations into
- ORR and preliminary duration of treatment data for the Phase 2 trial of silevertinib in 1L patients with non-classical EGFRm NSCLC on track for this quarter
- Cash, cash equivalents, and investments of
$135.5 million as of September 30, 2025; expected to be sufficient to fund operations into Q4 of 2027
CAMBRIDGE, Mass., Nov. 06, 2025 (GLOBE NEWSWIRE) -- Black Diamond Therapeutics, Inc. (Nasdaq: BDTX), a clinical-stage oncology company developing MasterKey therapies that target families of oncogenic mutations in patients with cancer, today reported financial results for the third quarter ended September 30, 2025, and provided a corporate update.
“We are looking forward to sharing a clinical update later this quarter from our silevertinib Phase 2 trial in newly diagnosed patients with EGFRm NSCLC,” said Mark Velleca, M.D., Ph.D., President and Chief Executive Officer of Black Diamond Therapeutics. “The update will include ORR and preliminary duration of treatment data, while PFS data is expected in the first half of 2026.”
Recent Developments & Upcoming Milestones:
Silevertinib
- Later this quarter, Black Diamond plans to disclose objective response rate (ORR) and preliminary duration of treatment data from all patients (n=43) in the Phase 2 trial of silevertinib in frontline non-small cell lung cancer (NSCLC) with non-classical epidermal growth factor receptor (EGFR) mutations.
- Black Diamond continues to explore partnership opportunities in NSCLC and glioblastoma (GBM) to advance silevertinib into pivotal development.
- The Company intends to solicit U.S. Food and Drug Administration (FDA) feedback on a potential registrational path in frontline EGFR mutant NSCLC in the first half of 2026, when progression free survival (PFS) data from the ongoing Phase 2 trial becomes available.
Financial Highlights
- Cash Position: Black Diamond ended the third quarter of 2025 with approximately
$135.5 million in cash, cash equivalents, and investments compared to$98.6 million as of December 31, 2024. Net cash used in operations was$7.9 million for the third quarter of 2025 compared to net cash used in operations of$11.3 million for the third quarter of 2024. - Research and Development Expenses: Research and development (R&D) expenses were
$7.4 million for the third quarter of 2025, compared to$12.9 million for the same period in 2024. The decrease in R&D expenses was primarily due to workforce efficiencies and outlicensing of BDTX-4933 to increase focus on the development of silevertinib. - General and Administrative Expenses: General and administrative (G&A) expenses were
$3.5 million for the third quarter of 2025, compared to$5.2 million for the same period in 2024. The decrease in G&A expenses was primarily due to the restructuring announced in October 2024. - Net Income/Loss: Net loss for the third quarter of 2025 was
$8.5 million , as compared to a net loss of$15.6 million for the same period in 2024.
Financial Guidance
- Black Diamond ended the third quarter of 2025 with approximately
$135.5 million in cash, cash equivalents and investments, which the Company believes is sufficient to fund its anticipated operating expenses and capital expenditure requirements into the fourth quarter of 2027.
About Black Diamond Therapeutics
Black Diamond Therapeutics is a clinical-stage oncology company developing MasterKey therapies that target families of oncogenic mutations in patients with cancer. The Company’s MasterKey therapies are designed to address a broad spectrum of genetically defined tumors, overcome resistance, minimize wild-type mediated toxicities, and be brain penetrant to treat central nervous system disease. The Company is advancing silevertinib, a brain-penetrant fourth-generation EGFR MasterKey inhibitor targeting EGFR-mutant NSCLC and GBM. For more information, please visit www.blackdiamondtherapeutics.com.
From time to time, we may use our website or our LinkedIn profile at www.linkedin.com/company/black-diamond-therapeutics to distribute material information. Our financial and other material information is routinely posted to and accessible on the Investors section of our website, available at www.blackdiamondtherapeutics.com. Investors are encouraged to review the Investors section of our website because we may post material information on that site that is not otherwise disseminated by us. Information that is contained in and can be accessed through our website or our LinkedIn page is not incorporated into, and does not form a part of, this press release.
Forward-Looking Statements
Statements contained in this press release regarding matters that are not historical facts are “forward-looking statements” within the meaning of the Private Securities Litigation Reform Act of 1995. Because such statements are subject to risks and uncertainties, actual results may differ materially from those expressed or implied by such forward-looking statements. Such statements include, but are not limited to, statements regarding: the continued development and advancement of silevertinib, including the ongoing Phase 2 clinical trial and the timing of clinical updates for silevertinib in patients with NSCLC and in patients with GBM, enrollment in the investigator sponsored Phase 0/1 clinical trial of silevertinib of newly diagnosed GBM patients with EGFR alterations, the expected timing for regulatory feedback and the disclosure of a potential registrational pathway for silevertinib in NSCLC, the potential of silevertinib to address the unmet medical need for newly diagnosed NSCLC patients with non-classical EGFR mutations and benefit patients with NSCLC across multiple lines of therapy, the potential future development plans for silevertinib in NSCLC and GBM, a potential partnership for silevertinib, and the Company’s expected cash runway. Any forward-looking statements in this press release are based on management’s current expectations of future events and are subject to a number of risks and uncertainties that could cause actual results to differ materially and adversely from those set forth in or implied by such forward-looking statements. Risks that contribute to the uncertain nature of the forward-looking statements include those risks and uncertainties set forth in its Annual Report on Form 10-K for the year ended December 31, 2024, filed with the United States Securities and Exchange Commission and in its subsequent filings filed with the United States Securities and Exchange Commission. All forward-looking statements contained in this press release speak only as of the date on which they were made. The Company undertakes no obligation to update such statements to reflect events that occur or circumstances that exist after the date on which they were made.
Black Diamond Therapeutics, Inc.
Condensed Consolidated Balance Sheet Data (Unaudited)
(in thousands)
| September 30, 2025 | December 31, 2024 | ||||||
| (in thousands) | |||||||
| Cash, cash equivalents, and investments | $ | 135,503 | $ | 98,575 | |||
| Total assets | $ | 157,733 | $ | 122,640 | |||
| Accumulated deficit | $ | (449,624) | $ | (487,107) | |||
| Total stockholders’ equity | $ | 126,152 | $ | 83,285 | |||
Black Diamond Therapeutics, Inc.
Consolidated Statements of Operations (Unaudited)
(in thousands, except per share data)
| Three Months Ended September 30, | Nine Months Ended September 30, | |||||||||||||
| 2025 | 2024 | 2025 | 2024 | |||||||||||
| License revenue | $ | — | $ | — | $ | 70,000 | $ | — | ||||||
| Operating expenses: | ||||||||||||||
| Research and development | $ | 7,437 | $ | 12,914 | $ | 27,262 | $ | 39,015 | ||||||
| General and administrative | 3,541 | 5,216 | 12,606 | 21,491 | ||||||||||
| Total operating expenses | 10,978 | 18,130 | 39,868 | 60,506 | ||||||||||
| Income (loss) from operations | (10,978) | (18,130) | 30,132 | (60,506) | ||||||||||
| Other income (expense): | ||||||||||||||
| Interest income | 1,164 | 516 | 2,877 | 1,617 | ||||||||||
| Other income (expense) | 1,316 | 2,057 | 4,474 | 5,198 | ||||||||||
| Total other income (expense), net | 2,480 | 2,573 | 7,351 | 6,815 | ||||||||||
| Net income (loss) | $ | (8,498) | $ | (15,557) | $ | 37,483 | $ | (53,691) | ||||||
| Net income (loss) per share - basic | $ | (0.15) | $ | (0.28) | $ | 0.66 | $ | (0.99) | ||||||
| Net income (loss) per share - diluted | $ | (0.15) | $ | (0.28) | $ | 0.65 | $ | (0.99) | ||||||
| Weighted average common shares outstanding - basic | 56,929,103 | 56,507,956 | 56,799,755 | 54,498,037 | ||||||||||
| Weighted average common shares outstanding - diluted | 56,929,103 | 56,507,956 | 57,480,512 | 54,498,037 | ||||||||||
Contact
For Investors:
investors@bdtx.com
For Media:
media@bdtx.com
FAQ
When will BDTX release ORR and duration data for silevertinib Phase 2 (n=43)?
What cash runway does BDTX report as of Sept 30, 2025?
When is progression‑free survival (PFS) data for silevertinib expected?
How did BDTX's operating expenses change in Q3 2025 versus Q3 2024?
What was BDTX's net loss and quarterly cash burn in Q3 2025?
Is BDTX seeking regulatory feedback on a registrational path for silevertinib?
