Black Diamond Therapeutics Reports Second Quarter 2025 Financial Results and Provides Corporate Update
Black Diamond Therapeutics (NASDAQ:BDTX) has reported its Q2 2025 financial results and provided significant updates on its clinical programs. The company has completed enrollment (n=43) in the Phase 2 trial of silevertinib for frontline non-classical EGFRm NSCLC patients, with ORR and preliminary DOR data expected in Q4 2025.
The company ended Q2 2025 with $142.8 million in cash and investments, up from $98.6 million at the end of 2024, providing runway into Q4 2027. Net loss improved to $10.6 million compared to $19.9 million in Q2 2024, with reduced R&D expenses of $9.3 million and G&A expenses of $4.1 million.
Black Diamond is actively exploring partnership opportunities for silevertinib's pivotal development in NSCLC and GBM, and plans to meet with the FDA in 1H 2026 regarding the 1L NSCLC development path when PFS data becomes available.
Black Diamond Therapeutics (NASDAQ:BDTX) ha comunicato i risultati finanziari del secondo trimestre 2025 e fornito aggiornamenti importanti sui suoi programmi clinici. L'azienda ha completato l'arruolamento (n=43) nella sperimentazione di Fase 2 di silevertinib per pazienti con NSCLC EGFRm non classico in prima linea, con dati su ORR e durata della risposta preliminare attesi nel quarto trimestre 2025.
Al termine del secondo trimestre 2025, la società disponeva di 142,8 milioni di dollari in liquidità e investimenti, in aumento rispetto ai 98,6 milioni di fine 2024, garantendo risorse fino al quarto trimestre 2027. La perdita netta è migliorata a 10,6 milioni di dollari rispetto ai 19,9 milioni del secondo trimestre 2024, con una riduzione delle spese in R&S a 9,3 milioni e delle spese amministrative a 4,1 milioni.
Black Diamond sta attivamente valutando opportunità di partnership per lo sviluppo cruciale di silevertinib in NSCLC e GBM, e prevede di incontrare la FDA nella prima metà del 2026 per discutere il percorso di sviluppo in prima linea per NSCLC quando saranno disponibili i dati di PFS.
Black Diamond Therapeutics (NASDAQ:BDTX) ha informado sus resultados financieros del segundo trimestre de 2025 y ha proporcionado actualizaciones importantes sobre sus programas clínicos. La compañía ha completado la inscripción (n=43) en el ensayo de Fase 2 de silevertinib para pacientes con NSCLC EGFRm no clásico en primera línea, con datos de ORR y duración preliminar de la respuesta esperados para el cuarto trimestre de 2025.
Al cierre del segundo trimestre de 2025, la empresa contaba con 142,8 millones de dólares en efectivo e inversiones, un aumento respecto a los 98,6 millones al final de 2024, proporcionando recursos hasta el cuarto trimestre de 2027. La pérdida neta mejoró a 10,6 millones de dólares comparado con 19,9 millones en el segundo trimestre de 2024, con gastos reducidos en I+D de 9,3 millones y gastos administrativos de 4,1 millones.
Black Diamond está explorando activamente oportunidades de asociación para el desarrollo pivotal de silevertinib en NSCLC y GBM, y planea reunirse con la FDA en la primera mitad de 2026 para discutir la ruta de desarrollo en primera línea para NSCLC cuando estén disponibles los datos de PFS.
Black Diamond Therapeutics (NASDAQ:BDTX)는 2025년 2분기 재무 결과를 발표하고 임상 프로그램에 대한 중요한 업데이트를 제공했습니다. 회사는 1차 비전형 EGFRm NSCLC 환자를 대상으로 한 silevertinib 2상 시험에서 모집을 완료했으며(n=43), 객관적 반응률(ORR)과 예비 반응 지속 기간(DOR) 데이터는 2025년 4분기에 발표될 예정입니다.
2025년 2분기 말 기준, 회사는 1억 4,280만 달러의 현금 및 투자 자산을 보유하고 있으며, 이는 2024년 말의 9,860만 달러에서 증가한 수치로 2027년 4분기까지 운영 자금을 확보했습니다. 순손실은 2024년 2분기의 1,990만 달러에서 개선되어 1,060만 달러로 줄었으며, 연구개발비는 930만 달러, 일반관리비는 410만 달러로 감소했습니다.
Black Diamond는 NSCLC 및 GBM에서 silevertinib의 중추적 개발을 위한 파트너십 기회를 적극 모색 중이며, 1차 NSCLC 개발 경로에 대해 2026년 상반기에 FDA와 회의를 계획하고 있으며, 이는 무진행 생존기간(PFS) 데이터가 확보된 후 진행될 예정입니다.
Black Diamond Therapeutics (NASDAQ:BDTX) a publié ses résultats financiers du deuxième trimestre 2025 et a fourni des mises à jour importantes sur ses programmes cliniques. La société a terminé l'inscription (n=43) à l'essai de phase 2 de silevertinib pour les patients atteints de NSCLC EGFRm non classique en première ligne, avec des données sur le taux de réponse objective (ORR) et la durée de réponse préliminaire (DOR) attendues au quatrième trimestre 2025.
La société a clôturé le deuxième trimestre 2025 avec 142,8 millions de dollars en liquidités et investissements, en hausse par rapport à 98,6 millions à la fin de 2024, offrant une visibilité financière jusqu'au quatrième trimestre 2027. La perte nette s'est améliorée à 10,6 millions de dollars contre 19,9 millions au deuxième trimestre 2024, avec des dépenses de R&D réduites à 9,3 millions et des frais administratifs à 4,1 millions.
Black Diamond explore activement des opportunités de partenariat pour le développement clé de silevertinib dans le NSCLC et le GBM, et prévoit de rencontrer la FDA au premier semestre 2026 pour discuter de la voie de développement en première ligne du NSCLC lorsque les données de survie sans progression (PFS) seront disponibles.
Black Diamond Therapeutics (NASDAQ:BDTX) hat die Finanzergebnisse für das zweite Quartal 2025 veröffentlicht und bedeutende Updates zu seinen klinischen Programmen gegeben. Das Unternehmen hat die Einschreibung (n=43) in der Phase-2-Studie von silevertinib für frontline nicht-klassische EGFRm NSCLC-Patienten abgeschlossen, wobei ORR- und vorläufige DOR-Daten im vierten Quartal 2025 erwartet werden.
Zum Ende des zweiten Quartals 2025 verfügte das Unternehmen über 142,8 Millionen US-Dollar an Barmitteln und Investitionen, ein Anstieg gegenüber 98,6 Millionen am Ende von 2024, was eine Finanzierung bis zum vierten Quartal 2027 sichert. Der Nettoverlust verbesserte sich auf 10,6 Millionen US-Dollar im Vergleich zu 19,9 Millionen im zweiten Quartal 2024, bei reduzierten F&E-Ausgaben von 9,3 Millionen und Verwaltungskosten von 4,1 Millionen.
Black Diamond prüft aktiv Partnerschaftsmöglichkeiten für die entscheidende Entwicklung von silevertinib bei NSCLC und GBM und plant, sich im ersten Halbjahr 2026 mit der FDA zu treffen, um den Entwicklungsweg für 1L NSCLC zu besprechen, sobald PFS-Daten verfügbar sind.
- Cash position strengthened to $142.8 million from $98.6 million at end of 2024
- Net loss improved by 47% year-over-year to $10.6 million
- Operating expenses decreased significantly with R&D down 26% and G&A down 57%
- Cash runway extended into Q4 2027
- Successfully completed Phase 2 trial enrollment for silevertinib
- Seeking partnership for pivotal development suggests potential capital constraints for independent development
- FDA meeting for development path delayed until 1H 2026
- Reduced R&D spending may impact pipeline development pace
Insights
Black Diamond reports strong cash position of $142.8M while preparing to share key Phase 2 silevertinib data in Q4 2025.
Black Diamond's silevertinib (BDTX-1535) program has reached a critical milestone with completed enrollment (n=43) in their Phase 2 trial for first-line non-classical EGFR-mutated non-small cell lung cancer (NSCLC). The upcoming Q4 2025 data readout will be pivotal as it will reveal objective response rate (ORR) and preliminary duration of response (DOR) metrics - both essential efficacy indicators that could determine the program's future.
The company is pursuing a two-pronged strategy: exploring partnership opportunities to accelerate pivotal development in both NSCLC and glioblastoma (GBM) indications, while also planning FDA discussions in 1H 2026 when progression-free survival (PFS) data becomes available. This staggered approach makes strategic sense, as the ORR/DOR data will inform partnership discussions, while the more mature PFS data will strengthen regulatory interactions.
The $142.8 million cash position provides a substantial runway into Q4 2027, which offers breathing room for both clinical development and partnership negotiations. The reduced quarterly cash burn of $9.2 million (down from $14.7 million in Q2 2024) demonstrates improved operational efficiency following their October 2024 restructuring, with significant reductions in both R&D ($9.3 million vs $12.6 million) and G&A expenses ($4.1 million vs $9.6 million). This operational streamlining, combined with the outlicensing of BDTX-4933, allows the company to focus resources on advancing silevertinib - potentially positioning it as a best-in-class treatment for non-classical EGFR mutations, a significant unmet need in lung cancer therapy.
Black Diamond shows improved financial discipline with 44% reduced cash burn while maintaining strong $142.8M position for future development.
Black Diamond's financial position has strengthened considerably, with cash reserves increasing to $142.8 million from $98.6 million at the end of 2024. Most notable is the significant improvement in operational efficiency, with quarterly cash burn decreasing by 37% to $9.2 million from $14.7 million in the comparable quarter last year. This operational discipline stems from two strategic initiatives: the October 2024 restructuring and the outlicensing of BDTX-4933 to focus resources on silevertinib.
The company has successfully reduced both R&D expenses ($9.3 million vs. $12.6 million, down 26%) and G&A expenses ($4.1 million vs. $9.6 million, down 57%). The dramatic reduction in G&A costs reflects a leaner corporate structure, while the more modest R&D reduction indicates maintained investment in core clinical programs while eliminating peripheral expenses.
The net quarterly loss has improved by 47% to $10.6 million from $19.9 million. With the current cash position and reduced burn rate, Black Diamond now projects runway into Q4 2027 – approximately 2.25 years of operational capability. This extended runway provides substantial flexibility for the company to navigate upcoming clinical milestones and potential partnership negotiations from a position of financial strength rather than necessity. The improved efficiency metrics and focused development strategy demonstrate management's commitment to capital preservation while advancing their lead asset to value-inflection points.
- Enrollment completed for the Phase 2 trial of silevertinib (BDTX-1535) in 1L patients with non-classical EGFRm NSCLC (n=43); ORR and preliminary DOR data on track for Q4 2025
- Exploring partnership opportunities to advance pivotal development of silevertinib in NSCLC and GBM
- Plan to meet with FDA regarding 1L NSCLC development path in 1H 2026, when PFS data becomes available
- Cash, cash equivalents, and investments of
$142.8 million as of June 30, 2025; expected to be sufficient to fund operations into Q4 of 2027
CAMBRIDGE, Mass., Aug. 07, 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 second quarter ended June 30, 2025, and provided a corporate update.
“With enrollment completed in our silevertinib Phase 2 trial for the treatment of newly diagnosed patients with EGFRm NSCLC, we look forward to sharing a clinical update in the fourth quarter of 2025,” said Mark Velleca, M.D., Ph.D., President and Chief Executive Officer of Black Diamond Therapeutics. “Given the evolving competitive and regulatory landscape, we are also exploring partnership opportunities to advance silevertinib into pivotal development and bring this potential best-in-class treatment to patients as quickly as possible.”
Recent Developments & Upcoming Milestones:
Silevertinib (BDTX-1535):
- In July 2025, Black Diamond completed enrollment (n=43) in the Phase 2 trial of silevertinib in frontline non-small cell lung cancer (NSCLC) patients with non-classical EGFR mutations.
- In the fourth quarter of 2025, Black Diamond expects to disclose objective response rate (ORR) and preliminary duration of response (DOR) data from all patients (n=43) in the Phase 2 trial of silevertinib in frontline NSCLC with non-classical EGFR mutations.
- Black Diamond is exploring partnership opportunities in NSCLC and glioblastoma (GBM) to advance silevertinib into pivotal development.
- The Company plans to solicit U.S. Food and Drug Administration (FDA) feedback on a potential registrational path in frontline EGFRm NSCLC in 1H 2026, when progression free survival (PFS) data from the ongoing Phase 2 trial becomes available.
Financial Highlights
- Cash Position: Black Diamond ended the second quarter of 2025 with approximately
$142.8 million in cash, cash equivalents, and investments compared to$98.6 million as of December 31, 2024. Net cash used in operations was$9.2 million for the second quarter of 2025 compared to net cash used in operations of$14.7 million for the second quarter of 2024. - Research and Development Expenses: Research and development (R&D) expenses were
$9.3 million for the second quarter of 2025, compared to$12.6 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
$4.1 million for the second quarter of 2025, compared to$9.6 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 second quarter of 2025 was
$10.6 million , as compared to a net loss of$19.9 million for the same period in 2024.
Financial Guidance
- Black Diamond ended the second quarter of 2025 with approximately
$142.8 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 a Phase 2 NSCLC trial of 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) | |||||||
| June 30, 2025 | December 31, 2024 | ||||||
| (in thousands) | |||||||
| Cash, cash equivalents, and investments | $ | 142,829 | $ | 98,575 | |||
| Total assets | $ | 166,385 | $ | 122,640 | |||
| Accumulated deficit | $ | (441,126 | ) | $ | (487,107 | ) | |
| Total stockholders’ equity | $ | 132,610 | $ | 83,285 | |||
| Black Diamond Therapeutics, Inc. Consolidated Statements of Operations (Unaudited) (in thousands, except per share data) | ||||||||||||||
| Three Months Ended June 30, | Six Months Ended June 30, | |||||||||||||
| 2025 | 2024 | 2025 | 2024 | |||||||||||
| License revenue | $ | — | $ | — | $ | 70,000 | $ | — | ||||||
| Operating expenses: | ||||||||||||||
| Research and development | $ | 9,319 | $ | 12,556 | $ | 19,825 | $ | 26,101 | ||||||
| General and administrative | 4,101 | 9,574 | 9,065 | 16,275 | ||||||||||
| Total operating expenses | 13,420 | 22,130 | 28,890 | 42,376 | ||||||||||
| Income (loss) from operations | (13,420 | ) | (22,130 | ) | 41,110 | (42,376 | ) | |||||||
| Other income (expense): | ||||||||||||||
| Interest income | 1,118 | 464 | 1,713 | 1,101 | ||||||||||
| Other income (expense) | 1,741 | 1,757 | 3,158 | 3,141 | ||||||||||
| Total other income (expense), net | 2,859 | 2,221 | 4,871 | 4,242 | ||||||||||
| Net income (loss) | $ | (10,561 | ) | $ | (19,909 | ) | $ | 45,981 | $ | (38,134 | ) | |||
| Net income (loss) per share - basic | $ | (0.19 | ) | $ | (0.36 | ) | $ | 0.81 | $ | (0.71 | ) | |||
| Net income (loss) per share - diluted | $ | (0.19 | ) | $ | (0.36 | ) | $ | 0.80 | $ | (0.71 | ) | |||
| Weighted average common shares outstanding - basic | 56,803,450 | 55,155,220 | 56,734,010 | 53,482,034 | ||||||||||
| Weighted average common shares outstanding - diluted | 56,803,450 | 55,155,220 | 57,474,118 | 53,482,034 | ||||||||||
Contact
For Investors:
investors@bdtx.com
For Media:
media@bdtx.com
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