Black Diamond Therapeutics (NASDAQ:BDTX) Issues Quarterly Earnings Results, Misses Expectations By $0.08 EPS

Key Points

• Black Diamond Therapeutics reported a quarterly loss of $0.17 per share, missing consensus expectations of a $0.09 loss by $0.08.
• In a 43-patient phase II study, systemic response was 60% and median progression-free survival was 15 months; the company also reported an 86% CNS response rate among patients with untreated brain metastases.
• The FDA aligned with the company on a broad trial population and CNS response as a potential accelerated-approval endpoint. The phase III trial is planned for Q2 2027, but its launch depends on safety data from the ongoing 150 mg cohort, and the encouraging results come from a small study without a concurrent control.

Black Diamond Therapeutics (NASDAQ:BDTX - Get Free Report) released its earnings results on Tuesday. The company reported ($0.17) EPS for the quarter, missing the consensus estimate of ($0.09) by ($0.08), FiscalAI reports.

Here are the key takeaways from Black Diamond Therapeutics' conference call:

• In the 43-patient frontline phase II study, systemic response rate remained 60% and median progression-free survival (PFS) 15 months after nearly 16 months of follow-up. The company reported an 86% CNS response rate and 12.2-month median PFS in patients with untreated brain metastases; among 24 patients without brain metastases, none developed them and median PFS was 23.5 months.
• Black Diamond said the FDA aligned on a broad trial population covering non-classical EGFR mutations, and on CNS response rate as the endpoint for potential accelerated approval; systemic PFS would support full approval. The agency also acknowledged the rationale for the 150 mg dose, subject to safety data from an ongoing cohort before phase III begins.
• The planned phase III trial is expected to start in Q2 2027, randomize about 300 patients with brain metastases against investigator-selected afatinib or osimertinib, and produce CNS response data in 2029. Patients without brain metastases are planned for a separate, single-arm cohort, with results potentially supporting guideline inclusion.
• The encouraging efficacy figures come from a small phase II study, and several comparisons cited by the company are against historical results rather than a concurrent control. The pivotal trial has not yet started, and its launch depends on providing the FDA with 150 mg cohort safety data.
• In glioblastoma, the randomized phase II study of silevertinib plus temozolomide versus temozolomide alone has completed its safety run-in and is enrolling at 150 mg. Interim PFS data are expected in the first half of 2028; no efficacy results were reported on the call.

Black Diamond Therapeutics Stock Performance

BDTX stock traded down $0.14 during midday trading on Tuesday, reaching $1.72. 408,063 shares of the company traded hands, compared to its average volume of 1,003,410. The firm has a market capitalization of $99.04 million, a price-to-earnings ratio of -2.29 and a beta of 3.48. Black Diamond Therapeutics has a 52-week low of $1.60 and a 52-week high of $4.94. The business has a 50 day moving average of $1.90 and a 200-day moving average of $2.17.

Analyst Ratings Changes

Several brokerages recently weighed in on BDTX. Jefferies Financial Group reaffirmed a "buy" rating on shares of Black Diamond Therapeutics in a report on Thursday, August 6th. TD Cowen reaffirmed a "buy" rating on shares of Black Diamond Therapeutics in a report on Thursday, August 6th. Raymond James Financial reissued an "outperform" rating on shares of Black Diamond Therapeutics in a report on Thursday, August 6th. Weiss Ratings reissued a "sell (d-)" rating on shares of Black Diamond Therapeutics in a report on Friday, October 9th. Finally, HC Wainwright reiterated a "buy" rating on shares of Black Diamond Therapeutics in a research report on Thursday, October 29th. Seven equities research analysts have rated the stock with a Buy rating, two have issued a Hold rating and one has issued a Sell rating to the stock. Based on data from MarketBeat, the stock presently has a consensus rating of "Moderate Buy" and an average target price of $11.00.

About Black Diamond Therapeutics

Black Diamond Therapeutics, Inc is a clinical-stage biopharmaceutical company focused on developing precision medicines for genetically defined cancers. The company uses its proprietary MasterKey platform to identify and develop small-molecule therapies designed to address oncogenic mutations across multiple tumor types, including alterations that may be difficult to target with conventional approaches.

Black Diamond's pipeline has included brain-penetrant therapies for cancers affecting the central nervous system.

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