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Black Diamond Therapeutics Reports Third Quarter 2024 Financial Results and Provides Corporate Update

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Black Diamond Therapeutics (BDTX) reported Q3 2024 financial results and corporate updates. The company announced encouraging Phase 2 data for BDTX-1535 in NSCLC patients, showing a 42% overall response rate in 19 patients with osimertinib resistance mutations. Cash position stood at $112.7 million as of September 30, 2024, expected to fund operations into Q2 2026. Q3 net loss improved to $15.6 million from $23.0 million year-over-year. The company implemented a corporate restructuring, deprioritizing BDTX-4933 to focus on BDTX-1535 development. Clinical updates and regulatory feedback are expected in Q1 2025.

Black Diamond Therapeutics (BDTX) ha riportato i risultati finanziari del terzo trimestre 2024 e gli aggiornamenti aziendali. L'azienda ha annunciato dati promettenti di Fase 2 per BDTX-1535 in pazienti con NSCLC, mostrando un tasso di risposta complessiva del 42% in 19 pazienti con mutazioni di resistenza a osimertinib. La posizione di liquidità si attestava a 112,7 milioni di dollari al 30 settembre 2024, prevista per finanziare le operazioni fino al secondo trimestre del 2026. La perdita netta del terzo trimestre è migliorata a 15,6 milioni di dollari, rispetto ai 23,0 milioni dell'anno precedente. L'azienda ha attuato una ristrutturazione aziendale, declassificando BDTX-4933 per concentrarsi sullo sviluppo di BDTX-1535. Aggiornamenti clinici e feedback normativi sono attesi nel primo trimestre del 2025.

Black Diamond Therapeutics (BDTX) informó sobre los resultados financieros del tercer trimestre de 2024 y las novedades corporativas. La empresa anunció datos alentadores de la Fase 2 para BDTX-1535 en pacientes con NSCLC, mostrando una tasa de respuesta general del 42% en 19 pacientes con mutaciones de resistencia a osimertinib. La posición de efectivo era de $112.7 millones al 30 de septiembre de 2024, y se espera que financie las operaciones hasta el segundo trimestre de 2026. La pérdida neta del tercer trimestre mejoró a $15.6 millones desde $23.0 millones en comparación con el año anterior. La empresa implementó una reestructuración corporativa, degradando BDTX-4933 para centrarse en el desarrollo de BDTX-1535. Se esperan actualizaciones clínicas y comentarios regulatorios en el primer trimestre de 2025.

블랙 다이아몬드 치료제 (BDTX)는 2024년 3분기 재무 결과 및 기업 업데이트를 발표했습니다. 이 회사는 NSCLC 환자에 대한 BDTX-1535의 2상 데이터가 수고하며, 오시머티닙 저항성 변이가 있는 19명의 환자에서 전체 반응률이 42%임을 보여주었습니다. 현금 보유액은 2024년 9월 30일 기준으로 1억 1,270만 달러였으며, 2026년 2분기까지 운영 자금을 지원할 것으로 예상됩니다. 3분기 순손실은 전년 대비 2,300만 달러에서 1,560만 달러로 개선되었습니다. 회사는 BDTX-4933의 우선순위를 낮추고 BDTX-1535 개발에 집중하기 위해 기업 구조 조정을 시행했습니다. 임상 업데이트와 규제 피드백은 2025년 1분기에 예상됩니다.

Black Diamond Therapeutics (BDTX) a publié ses résultats financiers pour le troisième trimestre 2024 ainsi que des mises à jour sur l'entreprise. La société a annoncé des données prometteuses de Phase 2 pour BDTX-1535 chez des patients atteints de NSCLC, avec un taux de réponse global de 42 % chez 19 patients présentant des mutations de résistance à osimertinib. La position de liquidités s'élevait à 112,7 millions de dollars au 30 septembre 2024, prévue pour financer les opérations jusqu'au deuxième trimestre 2026. La perte nette du troisième trimestre s'est améliorée, passant de 23,0 millions de dollars l'année précédente à 15,6 millions de dollars. L'entreprise a mis en œuvre une restructuration, en abaissant la priorité de BDTX-4933 pour se concentrer sur le développement de BDTX-1535. Des mises à jour cliniques et des retours réglementaires sont attendus au premier trimestre 2025.

Black Diamond Therapeutics (BDTX) hat die finanziellen Ergebnisse des dritten Quartals 2024 und Unternehmensaktualisierungen bekannt gegeben. Das Unternehmen gab ermutigende Phase-2-Daten für BDTX-1535 bei NSCLC-Patienten bekannt, die eine Gesamtrückgangsrate von 42% bei 19 Patienten mit Osimertinib-Resistenzmutationen zeigten. Die Liquiditätsposition belief sich am 30. September 2024 auf 112,7 Millionen Dollar, was voraussichtlich die Betriebsführung bis ins zweite Quartal 2026 ermöglicht. Der Nettoverlust im dritten Quartal verbesserte sich von 23,0 Millionen Dollar im Vorjahr auf 15,6 Millionen Dollar. Das Unternehmen führte eine Unternehmensumstrukturierung durch und setzte BDTX-4933 herab, um sich auf die Entwicklung von BDTX-1535 zu konzentrieren. Klinische Updates und regulatorisches Feedback werden im ersten Quartal 2025 erwartet.

Positive
  • 42% overall response rate in Phase 2 trial for BDTX-1535
  • Reduced net loss by 32% YoY to $15.6 million
  • Decreased R&D expenses to $12.9M from $16.2M YoY
  • Reduced G&A expenses to $5.2M from $7.9M YoY
  • Strong cash position of $112.7M with runway into Q2 2026
Negative
  • Corporate restructuring and workforce reduction implemented
  • Deprioritization of BDTX-4933 program
  • Cash position decreased from $131.4M at end of 2023 to $112.7M

Insights

The Q3 2024 financial report shows both positive and concerning elements. The company's cash position of $112.7 million provides a decent runway into Q2 2026, though burn rate remains significant at $11.3 million per quarter. The reduction in net loss to $15.6 million from $23.0 million YoY demonstrates improved cost management, with R&D expenses down $3.3 million and G&A expenses reduced by $2.7 million.

The corporate restructuring and deprioritization of BDTX-4933 indicate a strategic focus on BDTX-1535, their lead candidate. The 42% preliminary ORR in osimertinib-resistant patients is promising, though the sample size (19 patients) is small. The upcoming Q1 2025 clinical updates and potential FDA feedback will be important catalysts for the stock.

The BDTX-1535 Phase 2 data shows encouraging clinical potential in a difficult-to-treat patient population. The 42% ORR in osimertinib-resistant NSCLC patients with C797S or PACC mutations represents a significant advancement, particularly given the 8+ month duration of response in early responders. The drug's favorable tolerability profile at 200mg daily dose and the retention of 14 out of 19 patients on treatment suggest strong clinical utility.

The real-world data presented at ESMO highlighting treatment heterogeneity in non-classical EGFR mutations (36% targeted therapy vs 60% chemo/immunotherapy) indicates a clear unmet medical need that BDTX-1535 could potentially address. The positive brain penetration data from the Ivy Brain Tumor Center study also opens possibilities for glioblastoma treatment.

  • Announced encouraging initial Phase 2 data of BDTX-1535 in patients with recurrent EGFRm NSCLC with a broad spectrum of classical, non-classical, and C797S resistance mutations in September 2024
  • Presented real-world treatment practices and patient outcomes in newly diagnosed NSCLC patients with non-classical EGFR mutations at the 2024 ESMO Congress
  • Clinical updates of BDTX-1535 in EGFRm NSCLC and regulatory feedback expected in Q1 2025
  • Cash, cash equivalents, and investments of $112.7 million as of September 30, 2024; expected to be sufficient to fund operations into Q2 of 2026

CAMBRIDGE, Mass., Nov. 05, 2024 (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, 2024, and provided a corporate update.

“We are focused on the advancement of BDTX-1535 for the treatment of patients with EGFRm NSCLC and look forward to providing clinical updates on our Phase 2 trial for both newly diagnosed patients and patients with relapsed/refractory EGFRm NSCLC in the first quarter of 2025,” said Mark Velleca, M.D., Ph.D., Chief Executive Officer of Black Diamond Therapeutics. “We also look forward to sharing feedback on a registrational path in relapsed/refractory EGFRm NSCLC following a meeting planned with the FDA in the first quarter of 2025.”

Recent Developments & Upcoming Milestones:

BDTX-1535:

  • In September 2024, Black Diamond announced initial Phase 2 data demonstrating encouraging clinical responses and durability of BDTX-1535 in patients with relapsed/refractory epidermal growth factor receptor (EGFR) mutant (EGFRm) non-small cell lung cancer (NSCLC). The 200 mg daily dose of BDTX-1535 was selected for pivotal development, showing robust EGFRm target coverage and a favorable tolerability profile with no new safety signals observed. A preliminary overall response rate (ORR) of 42% was seen in 19 patients with known osimertinib resistance EGFR mutations (either C797S or PACC “P-loop αC-helix compressing” mutations). Encouraging durability was noted with a duration of response (DOR) of approximately eight months or more in the first three patients who achieved a partial response (PR), while 14 of the 19 patients remained on treatment.
  • In September 2024, Black Diamond presented a poster analyzing real-world treatment outcomes for newly diagnosed NSCLC patients with non-classical EGFR mutations (NCMs) at the 2024 European Society for Medical Oncology (ESMO) Congress. The analyses revealed the presence of a broad spectrum of NCMs, including PACC mutations, and allowed association with real-world treatment practices and therapeutic outcomes. Findings further demonstrated that current treatment practices for patients with NCMs are heterogenous: 36% of patients received osimertinib or afatinib and 60% of patients received chemotherapy and/or immunotherapy.
  • In October 2024, the Ivy Brain Tumor Center, which is sponsoring a “window of opportunity” (also known as Phase 0/1 “Trigger”) trial of BDTX-1535 in patients with recurrent high-grade glioma (HGG), presented updated study results demonstrating that BDTX-1535 effectively penetrates rarely accessible regions of glioblastoma and suppresses EGFR signaling in patient tumors at the 19th Meeting of the European Association of Neuro-Oncology. These encouraging data provide rationale for the program’s expansion into newly diagnosed glioblastoma patients with EGFR aberrations.
  • In the first quarter of 2025, Black Diamond expects to disclose initial Phase 2 data in first-line EGFRm NSCLC patients with non-classical mutations as well as updated Phase 2 results in the recurrent EGFRm NSCLC setting (NCT05256290) together with an update on a potential registrational path for the recurrent setting.

Corporate

  • In October 2024, Black Diamond announced a corporate restructuring plan to prioritize its resources on advancing and optimizing development plans for its lead program BDTX-1535, strengthen operational efficiencies and extend the Company’s expected cash runway into the second quarter of 2026. As part of the restructuring, Black Diamond also deprioritized its Phase 1 RAS/RAF inhibitor, BDTX-4933, and is actively seeking partnerships for the program.

Financial Highlights

  • Cash Position: Black Diamond ended the third quarter of 2024 with approximately $112.7 million in cash, cash equivalents, and investments compared to $131.4 million as of December 31, 2023. Net cash used in operations was $11.3 million for the third quarter of 2024 compared to $18.4 million for the third quarter of 2023.
  • Research and Development Expenses: Research and development (R&D) expenses were $12.9 million for the third quarter of 2024, compared to $16.2 million for the same period in 2023. The decrease in R&D expenses was primarily due to workforce efficiencies and reduced spending on early discovery projects.
  • General and Administrative Expenses: General and administrative (G&A) expenses were $5.2 million for the third quarter of 2024, compared to $7.9 million for the same period in 2023. The decrease in G&A expenses was primarily due to a decrease in consulting and other professional fees.
  • Net Loss: Net loss for the third quarter of 2024 was $15.6 million, as compared to $23.0 million for the same period in 2023.

Financial Guidance

  • Black Diamond ended the third quarter of 2024 with approximately $112.7 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 second quarter of 2026.

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 BDTX-1535, 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 potential of BDTX-1535 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 continued development and advancement of BDTX-1535, including the ongoing clinical trials and the timing of clinical updates for BDTX-1535 in patients with NSCLC, the expected timing for regulatory feedback and the disclosure of potential registrational pathways for BDTX-1535 in NSCLC, potential partnership opportunities for BDTX-4933, the expected cost savings from the corporate restructuring plan, the potential future development plans for BDTX-1535 in NSCLC and GBM, 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, 2023, 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,
2024
 December 31,
2023
 (in thousands)
Cash, cash equivalents, and investments$112,682  $131,400 
Total assets$137,896  $158,567 
Accumulated deficit$(471,122) $(417,431)
Total stockholders’ equity$97,426  $116,736 


 
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,
  2024   2023   2024   2023 
Operating expenses:       
Research and development$12,914  $16,154  $39,015  $44,061 
General and administrative 5,216   7,858   21,491   21,544 
Total operating expenses 18,130   24,012   60,506   65,605 
Loss from operations (18,130)  (24,012)  (60,506)  (65,605)
Other income (expense):       
Interest income 516   439   1,617   1,600 
Other income (expense) 2,057   566   5,198   971 
Total other income (expense), net 2,573   1,005   6,815   2,571 
Net loss$(15,557) $(23,007) $(53,691) $(63,034)
Net loss per share, basic and diluted$(0.28) $(0.45) $(0.99) $(1.54)
Weighted average common shares outstanding, basic and diluted 56,507,956   50,943,155   54,498,037   41,367,347 


Contact

For Investors:
investors@bdtx.com 

For Media:
media@bdtx.com 


FAQ

What were Black Diamond Therapeutics (BDTX) Q3 2024 financial results?

BDTX reported a net loss of $15.6 million, with $112.7 million in cash and investments. R&D expenses were $12.9 million and G&A expenses were $5.2 million.

What was the efficacy of BDTX-1535 in the Phase 2 trial?

BDTX-1535 showed a 42% overall response rate in 19 patients with osimertinib resistance EGFR mutations, with duration of response of approximately eight months or more in the first three responding patients.

When will BDTX provide the next clinical update for BDTX-1535?

Black Diamond expects to provide clinical updates on the Phase 2 trial and regulatory feedback in Q1 2025.

Black Diamond Therapeutics, Inc.

NASDAQ:BDTX

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168.95M
56.51M
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95.26%
12.96%
Biotechnology
Biological Products, (no Disgnostic Substances)
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United States of America
CAMBRIDGE