Is BDTX's Cash balance Enough to Successfully Develop Its NSCLC Drug?

Black Diamond Therapeutics, Inc. (BDTX) is developing MasterKey therapies that target families of oncogenic mutations in patients with cancer. The company’s lead pipeline candidate is silevertinib.

Silevertinib is a brain penetrant, fourth-generation epidermal growth factor receptor (EGFR) MasterKey inhibitor targeting epidermal growth factor receptor mutant (EGFRm) non-small cell lung cancer (NSCLC) and glioblastoma (GBM).

The company recently completed enrollment in the mid-stage study of silevertinib in frontline NSCLC patients with non-classical EGFR mutations.

Black Diamond ended the second quarter of 2025 with approximately $142.8 million in cash and cash equivalents. The company believes that this cash balance is sufficient to fund its anticipated operating expenses and capital expenditure requirements into the fourth quarter of 2027.

Operating expenses in the second quarter plunged 39% due to a decline in R&D and G&A expenses. The decrease in R&D expenses was primarily due to workforce efficiencies and the outlicensing of BDTX-4933, which allowed for an increased focus on the development of silevertinib.

BDTX entered into a global licensing agreement with Servier Pharmaceuticals in March 2025 for its second clinical-stage asset, BDTX-4933, a potential best-in-class targeted therapy for RAF/RAS-mutant solid tumors. The company received an upfront payment of $70.0 million.

Following the outlicensing of its other pipeline candidate, BDTX-4933, to Servier Pharmaceuticals, BDTX is solely focused on the development of silevertinib.

G&A expenses declined primarily due to the restructuring announced in October 2024.

Black Diamond Therapeutics is currently looking for strategic partners to advance further development of silevertinib for NSCLC and GBM.

Competition for BDTX’s Oncology Drug

The NSCLC space is dominated by pharma bigwigs. In August 2024, Johnson & Johnson (JNJ) obtained FDA approval of Rybrevant (amivantamab-vmjw) plus Lazcluze (lazertinib) for the first-line treatment of adult patients with locally advanced or metastatic NSCLC with EFGR exon 19 deletions or exon 21 L858R substitution mutations, as detected by an FDA-approved test.

Following the approval, JNJ’s Rybrevant plus Lazcluze became the first and only multitargeted, chemotherapy-free combination regimen with demonstrated superiority versus AstraZeneca’s (AZN) Tagrisso (osimertinib), approved for the first-line treatment of patients with EGFR-mutated NSCLC.

Earlier, in March 2024, JNJ obtained FDA approval for Rybrevant in combination with chemotherapy (carboplatin-pemetrexed) for the first-line treatment of patients with locally advanced or metastatic NSCLC with EGFR exon 20 insertion mutations.

In patients with EGFR non-classical mutations, silevertinib will compete with AZN’s Tagrisso, which is a third-generation, irreversible EGFR-TKI with proven clinical activity in NSCLC, including against central nervous system metastases.

AZN is also evaluating Tagrisso in the early-stage adjuvant lung cancer in the resectable setting in a phase III study.

BDTX Price Performance, Valuation and Estimates

Shares of BDTX have surged 57.5% year to date compared with the industry’s growth of 5.6%.

From a valuation standpoint, BDTX is inexpensive. Going by the price/book ratio, BDTX’s shares currently trade at 1.45x book value, higher than its mean of 1.31x but lower than the biotech industry’s 3.16x.

The bottom-line estimate for 2025 has moved north to 33 cents in the past 60 days while that for 2026 has improved 10 cents to a loss of 82 cents per share.

BDTX currently carries a Zacks Rank #2 (Buy). You can see the complete list of today’s Zacks #1 Rank (Strong Buy) stocks here.

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This article originally published on Zacks Investment Research (zacks.com).

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