Black Diamond Therapeutics (NASDAQ:BDTX) Posts Earnings Results, Misses Estimates By $0.08 EPS

Black Diamond Therapeutics (NASDAQ:BDTX) issued its earnings results on Tuesday. The company reported ($0.17) EPS for the quarter, missing analysts’ consensus estimates of ($0.09) by ($0.08), FiscalAI reports.

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

• Black Diamond said its FDA end-of-phase II meeting established a path toward accelerated approval for silevertinib in non-classical EGFR-mutant lung cancer, using CNS objective response rate as an endpoint. The planned phase III trial is expected to begin in the second quarter and will include a randomized brain-metastasis cohort and a single-arm cohort for patients without brain metastases.
• In the company’s 43-patient phase II study, silevertinib produced an 86% CNS response rate and median progression-free survival of 12.2 months among patients with brain metastases, according to management. The company compared these results favorably with published data for existing drugs, while noting the comparisons are across different studies.
• The FDA accepted the company’s proposed 150 mg phase III dose subject to additional safety data, particularly on dose reductions; Black Diamond said it expects to provide that data before starting the trial. Management said dose reductions at the 200 mg phase II dose were relatively frequent, though it characterized the side effects as familiar EGFR-related events.
• Black Diamond said its plans include a randomized phase II glioblastoma study, with interim progression-free-survival data expected in the first half of 2028, but acknowledged that it will need additional capital to reach its clinical and approval milestones. The company is considering both dilutive and non-dilutive funding, as well as potential partnerships for ex-U.S. rights.

Black Diamond Therapeutics Stock Performance

Shares of NASDAQ BDTX opened at $1.61 on Thursday. Black Diamond Therapeutics has a 1 year low of $1.58 and a 1 year high of $4.94. The stock’s 50-day simple moving average is $1.88 and its 200-day simple moving average is $2.16. The firm has a market cap of $92.50 million, a price-to-earnings ratio of -2.09 and a beta of 3.48.

Wall Street Analyst Weigh In

A number of analysts recently weighed in on the stock. Jefferies Financial Group reaffirmed a “buy” rating on shares of Black Diamond Therapeutics in a research report on Thursday, August 6th. Raymond James Financial restated an “outperform” rating on shares of Black Diamond Therapeutics in a research note on Tuesday. TD Cowen restated a “buy” rating on shares of Black Diamond Therapeutics in a research note on Thursday, August 6th. Wall Street Zen raised Black Diamond Therapeutics from a “sell” rating to a “hold” rating in a research report on Saturday, October 24th. Finally, Weiss Ratings reiterated a “sell (d-)” rating on shares of Black Diamond Therapeutics in a research note on Friday, October 9th. Seven research analysts have rated the stock with a Buy rating, two have issued a Hold rating and one has assigned a Sell rating to the company. According to data from MarketBeat, the stock has an average rating of “Moderate Buy” and a consensus price target of $11.00.

Black Diamond Therapeutics Company Profile

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.