Black Diamond Therapeutics — Q3 2026 Earnings Summary

Financial Performance:

• Cash, cash equivalents, and investments totaled $102.0 million as of September 30, 2026, compared to $128.7 million as of December 31, 2025.
• Net cash used in operations was $8.3 million for the three months ended September 30, 2026, compared to $7.9 million for the same period in 2025.
• Research and development expenses were $7.0 million for the quarter ended September 30, 2026, down from $7.4 million in the same period of 2025.
• General and administrative expenses were $5.1 million for the quarter ended September 30, 2026, up from $3.5 million in the same period of 2025.
• Net loss for the third quarter of 2026 was $10.0 million, compared to a net loss of $8.5 million for the same period in 2025.
• Total operating expenses for the nine months ended September 30, 2026, were $35.4 million, compared to $39.9 million for the same period in 2025.
• Net loss for the nine months ended September 30, 2026, was $29.0 million, compared to a net income of $37.5 million for the same period in 2025.
• Accumulated deficit increased to $493.7 million as of September 30, 2026, from $464.7 million as of December 31, 2025.

Guidance and Future Outlook:

• The company expects its current cash position to be sufficient to fund operations into the second half of 2028.
• A global Phase 3 registrational trial for silevertinib is planned to potentially initiate in the second quarter of 2027.
• Preliminary data from the Phase 3 trial is anticipated in 2028.
• Interim PFS data for the Phase 2 trial in newly diagnosed GBM is expected in the first half of 2028.
• The company intends to submit safety data from Cohort 4 (150 mg QD) to the FDA prior to opening the Phase 3 trial.

Business Segments and Product Lines:

• Updated Phase 2 results for silevertinib in 1L EGFR-NCM NSCLC (n=43) showed a 60% ORR, 93% DCR, and 15.0-month mPFS.
• In patients with untreated brain metastases (n=16), silevertinib demonstrated an 86% CNS-ORR and 12.2-month systemic mPFS.
• In patients without brain metastases (n=24), silevertinib showed a 23.5-month mPFS with no patients experiencing brain progression.
• No new safety signals were observed in the Phase 2 NSCLC trial.
• Cohort 4 of the Phase 2 NSCLC trial is enrolling frontline patients at the pivotal dose of 150 mg QD, with the first patient dosed in Q3 2026.
• The randomized portion of the Phase 2 trial in newly diagnosed EGFRvIII+ GBM is enrolling patients at 150 mg QD, with the first patient dosed in Q4 2026.
• Over 200 patients with EGFRm NSCLC or EGFR-altered GBM have been treated with silevertinib to date.

Market and Competitive Landscape:

• EGFR-NCM patients represent approximately 25% of the frontline EGFR mutant patient population.
• Brain metastases are the most common site of distant metastasis for patients with EGFR-mutant NSCLC.
• The Phase 3 trial design compares silevertinib 150 mg QD against physician's choice of osimertinib or afatinib.
• The company notes that cross-trial comparisons with currently available EGFR TKIs are limited by differences in trial design, patient population, endpoints, and dosing.

Risks and Challenges:

• FDA feedback is not binding and the agency may change its views, disagree with the company's interpretation, or require additional data or trials.
• Interim or preliminary clinical data may change as more patient data become available.
• Actual results may differ materially from forward-looking statements due to risks and uncertainties.
• The company references risks detailed in its Annual Report on Form 10-K for the year ended December 31, 2025.

Management Commentary and Tone:

• CEO Mark Velleca stated the recent End of Phase 2 meeting with the FDA was "highly collaborative" and supports a clear path to potential accelerated and full approval.
• CMO Sergey Yurasov highlighted that silevertinib's ability to significantly delay CNS progression is the key driver of durable clinical benefit.
• Clinical investigator Alex Spira noted the "remarkable" finding that no frontline patient treated with silevertinib developed de novo brain metastases.
• Management expressed confidence in the pivotal program design for 1L NSCLC patients with EGFR-NCMs.

Other Key Points:

• The FDA supported a potential accelerated approval based on CNS-ORR (RANO-BM) and a potential full approval based on PFS (RECIST v1.1).
• The FDA indicated that systemic ORR and overall survival (OS) must be evaluated to show similarity to the control arm and no OS detriment.
• The Phase 3 trial plans to enroll 300 patients with untreated brain metastases, plus an 80-patient single-arm cohort without brain metastases and a 20-patient cohort with leptomeningeal disease.
• The company will host an investor call at 7:30 am ET and participate in a fireside chat at the Stifel 2026 Healthcare Conference at 3:20 pm ET.
• License revenue was $0 for the three months ended September 30, 2026, and $70.0 million for the nine months ended September 30, 2025.
• Interest income was $0.8 million for the quarter ended September 30, 2026, compared to $1.2 million in the same period of 2025.