Black Diamond Therapeutics Announces Restructuring Plan to Focus Resources on BDTX-1535 and Extend Cash Runway

Rhea-AI Summary

Black Diamond Therapeutics (Nasdaq: BDTX) announced a corporate restructuring to focus resources on advancing its lead program BDTX-1535 into pivotal development for EGFRm NSCLC. The company aims to extend its cash runway into Q2 2026. Key points include:

• Anticipates sharing initial Phase 2 data for BDTX-1535 in the frontline setting for EGFRm NSCLC in Q1 2025
• Plans to present updated Phase 2 results for BDTX-1535 in recurrent EGFRm NSCLC in Q1 2025
• Deprioritizing BDTX-4933 program and seeking potential partners
• Implementing a reduction in force while retaining core expertise
• Chief Business Officer, CFO, and Chief People Officer departing; Erika Jones appointed as Principal Financial Officer

The restructuring aims to optimize operations and focus investment on BDTX-1535, which has shown robust Phase 2 clinical activity in recurrent NSCLC patients with EGFR mutations.

Positive

• BDTX-1535 demonstrated robust Phase 2 clinical activity in EGFRm NSCLC patients
• Anticipated cost savings expected to extend cash runway into Q2 2026
• Company plans to present key Phase 2 data for BDTX-1535 in Q1 2025
• Restructuring allows focused investment in lead program BDTX-1535

Negative

• Deprioritization of BDTX-4933 program
• Reduction in workforce
• Departure of key executives including Chief Business Officer, CFO, and Chief People Officer

Insights

Financial Analyst

This restructuring announcement from Black Diamond Therapeutics is significant for investors. The company is making strategic moves to focus on its lead program BDTX-1535, which has shown promising Phase 2 results in EGFRm NSCLC. Key points to consider:

• Cash runway extension into Q2 2026, providing financial stability
• Deprioritization of BDTX-4933, seeking partnerships to potentially unlock value
• Workforce reduction to optimize operations and reduce costs
• Upcoming catalysts in Q1 2025 with Phase 2 data for BDTX-1535 in frontline and recurrent settings

The restructuring aims to streamline operations and allocate resources more efficiently. While the departure of key executives may raise concerns, the focus on BDTX-1535 and the extended cash runway could position the company for potential success in the competitive oncology market. Investors should closely monitor the upcoming data readouts in Q1 2025, as they will be critical in determining the long-term prospects of BDTX-1535 and the company's overall value proposition.

Oncology Expert

The focus on BDTX-1535 is a strategic move based on its promising clinical activity. As an oral TKI targeting a broad spectrum of EGFR mutations in NSCLC, it has potential across multiple treatment lines. Key considerations:

• Robust Phase 2 activity in recurrent EGFRm NSCLC
• Upcoming frontline data in Q1 2025 could expand market potential
• Potential registration path in the recurrent setting based on FDA feedback

The decision to deprioritize BDTX-4933 in RAF/RAS-mutant solid tumors is pragmatic, allowing resources to be concentrated on the more advanced BDTX-1535 program. The company's strategy aligns with the trend towards targeted therapies in oncology. The well-tolerated profile of BDTX-1535 is particularly noteworthy, as it could differentiate the drug in a competitive landscape where side effect management is crucial. Investors should pay attention to the upcoming data, as positive results could significantly impact the company's valuation and potential partnerships or acquisition interest.

Company advancing BDTX-1535 in EGFRm NSCLC towards key inflection points in Q1 2025

Will deprioritize BDTX-4933 and seek potential partners

Anticipated cost savings expected to extend cash runway into Q2 2026

CAMBRIDGE, Mass., Oct. 07, 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, announced today a corporate restructuring to focus resources on advancing lead program BDTX-1535 into pivotal development, and to extend the Company’s expected cash runway into Q2 2026. BDTX-1535 has demonstrated robust Phase 2 clinical activity across a broad spectrum of epidermal growth factor receptor mutations (EGFRm) in patients with recurrent non-small cell lung cancer (NSCLC).

In Q1 2025, Black Diamond anticipates sharing initial Phase 2 data for BDTX-1535 in the frontline setting for patients with EGFRm NSCLC. Also in Q1 2025, the Company plans to present updated Phase 2 results for BDTX-1535 in patients with recurrent EGFRm NSCLC and a potential registration path in the recurrent setting based on feedback from the FDA.

Black Diamond is actively seeking partnerships as it deprioritizes its BDTX-4933 program in RAF/RAS-mutant solid tumors. To enable focused investment in BDTX-1535, Black Diamond has also taken steps to optimize operations, including a reduction in force, while retaining core drug development and management expertise. As part of the restructuring, Chief Business Officer and Chief Financial Officer Fang Ni and Chief People Officer Elizabeth Montgomery are departing the Company. Erika Jones, Senior Vice President of Finance and Principal Accounting Officer, has been appointed Principal Financial Officer of the Company. Cost savings from the restructuring and other actions described above are expected to be sufficient to fund operations into Q2 2026.

“BDTX-1535 is a well-tolerated oral TKI with the potential to benefit patients with EGFRm NSCLC across multiple lines of therapy,” said Mark Velleca, M.D., Ph.D., Chief Executive Officer of Black Diamond Therapeutics. “We remain focused on advancing BDTX-1535 and presenting additional Phase 2 data in Q1 2025. I am deeply grateful to each member of the Black Diamond team, whose hard work and valuable contributions have brought us to the threshold of pivotal development for our lead program.”

About BDTX-1535

BDTX-1535 is an oral, brain-penetrant MasterKey inhibitor of oncogenic EGFR mutations in NSCLC, including classical mutations, non-classical mutations, and the C797S resistance mutation. BDTX-1535 is a fourth-generation tyrosine kinase inhibitor (TKI) that potently inhibits, based on preclinical data, more than 50 EGFR mutations expressed across a diverse group of patients with NSCLC in multiple lines of therapy. Based on preclinical data, BDTX-1535 also inhibits EGFR extracellular domain mutations and alterations commonly expressed in glioblastoma (GBM) and avoids paradoxical activation observed with earlier generation reversible TKIs. A “window of opportunity” trial of BDTX-1535 in patients with GBM is ongoing (NCT06072586) and a Phase 2 trial is ongoing in patients with NSCLC (NCT05256290).

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.

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 patients with recurrent NSCLC and 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 restructuring; and 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.

Contacts

For Investors:
investors@bdtx.com

For Media:
media@bdtx.com

FAQ

What is the main focus of Black Diamond Therapeutics' restructuring plan?

The main focus of Black Diamond Therapeutics' restructuring plan is to concentrate resources on advancing their lead program BDTX-1535 into pivotal development for EGFRm NSCLC and to extend the company's cash runway into Q2 2026.

When will Black Diamond Therapeutics (BDTX) share initial Phase 2 data for BDTX-1535 in frontline EGFRm NSCLC?

Black Diamond Therapeutics anticipates sharing initial Phase 2 data for BDTX-1535 in the frontline setting for patients with EGFRm NSCLC in Q1 2025.

What is happening to the BDTX-4933 program as part of Black Diamond Therapeutics' restructuring?

As part of the restructuring, Black Diamond Therapeutics is deprioritizing the BDTX-4933 program in RAF/RAS-mutant solid tumors and actively seeking partnerships for it.

How has the restructuring affected Black Diamond Therapeutics' (BDTX) leadership team?

The restructuring has resulted in the departure of the Chief Business Officer and CFO Fang Ni, and Chief People Officer Elizabeth Montgomery. Erika Jones, Senior Vice President of Finance and Principal Accounting Officer, has been appointed as the Principal Financial Officer.