Black Diamond Therapeutics, Inc.
BDTX evidence brief
What we can confirm
What it means
What to watch
Prepared research question
What matters most for BDTX—catalysts, financial risk and supporting evidence?
Traceable citations · Unknowns marked
BioSniper AI · BDTX
Black Diamond Therapeutics is a clinical-stage biopharmaceutical company focused on developing allosteric small molecule inhibitors targeting oncogenic mutations, with its lead candidate silevertinib (BDTX-1535) in Phase 2 trials for non-small cell lung cancer.
Key risk: Clinical development risk
BioSniper Score
Based on 5 of 6 signals
Market Cap
$128.1M
Cash Runway
40.7 moLead Asset
BDTX-1535 (Phase 2)Next Catalyst
Phase2_Topline · Dec 31, 2026Financial data as of Jun 30, 2026.
Tracking 4 pipeline candidates · 25 clinical trials · 4 catalysts for Black Diamond Therapeutics, Inc..
Black Diamond Therapeutics is a clinical-stage biopharmaceutical company focused on developing allosteric small molecule inhibitors targeting oncogenic mutations, with its lead candidate silevertinib (BDTX-1535) in Phase 2 trials for non-small cell lung cancer.
- Lead candidate silevertinib (BDTX-1535) is a potential best-in-class allosteric inhibitor targeting EGFR mutations in non-small cell lung cancer [sec_mda · as of 2026-08-05].
- Cash and equivalents of $20.0M as of 2026-06-30, with a net loss of $9.9M for the quarter [sec].
- Accumulated deficit of $483.7M as of June 30, 2026, reflecting ongoing R&D and operational costs [sec_mda · as of 2026-08-05].
- Company has no approved products and has not generated any revenue to date [sec].
- Upcoming catalysts include Phase 2 topline data for silevertinib expected by end of 2026 [catalyst_timeline].
What works
- Silevertinib is designed to target a broad range of EGFR mutations, including those resistant to current therapies, potentially addressing a significant unmet need [sec_mda · as of 2026-08-05].
- The company has a robust intellectual property portfolio and is advancing its pipeline through strategic collaborations [sec_mda · as of 2026-08-05].
What to weigh
- The company has an accumulated deficit of $483.7M and expects expenses to increase substantially as it advances clinical trials, with no product revenue to offset costs [sec_mda · as of 2026-08-05].
- Clinical development of silevertinib is still in Phase 2, and there is no guarantee of successful completion or regulatory approval [sec_mda · as of 2026-08-05].
- The company's ability to achieve profitability depends heavily on successful development and commercialization of its product candidates, which is uncertain [sec_mda · as of 2026-08-05].
From the filings
Quoted directly from source documents.
Accumulated deficit as of June 30, 2026
“June 30, 2026, we had an accumulated deficit of $483.7 million.”
SEC MD&A · August 5, 2026
Catalyst timeline
- 2026-12-31 · Phase2_Topline · silevertinib — Phase 2 Readout: silevertinib — Topline data from the Phase 2 trial of silevertinib will be a key efficacy and safety readout for the lead candidate.
Risks & what to watch (4)›
Key risks
- Clinical development risk — Silevertinib is in Phase 2; failure to demonstrate efficacy or safety could halt development [sec_mda · as of 2026-08-05].
- Financial sustainability — With $20.0M cash and no revenue, the company may need additional funding to continue operations [sec].
- Regulatory approval uncertainty — No product candidates have received regulatory approval; approval process is lengthy and uncertain [sec_mda · as of 2026-08-05].
- Competitive landscape — Multiple targeted therapies exist for EGFR-mutant NSCLC; silevertinib must differentiate to succeed [sec_mda · as of 2026-08-05].
What to watch
- Phase 2 topline data for silevertinib expected by end of 2026 [catalyst_timeline].
- Cash runway and potential need for additional financing [sec].
- Progress in advancing silevertinib through clinical trials and any partnership developments [sec_mda · as of 2026-08-05].
Sources: SEC MD&A · Generated August 29, 2026 · How we verify sources →
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Evidence & data
Score breakdownBased on 5 of 6 signals · derived from public data
40.7 months
D/E 0.30 · 0% dilution
Lead: Phase 2
4 candidates
4 upcoming, next in ~123d
No insider transactions in the last 180 days
Runway
Catalysts
Pipeline
Regulatory
Financials
Institutional Holdings
Source: SEC Form 13F · as of Mar 2026Institutional holders
101
Total value held
$45.0M
| Holder | Shares | Value |
|---|---|---|
| vanguard capital management llc | 1,850,468 | $3.9M |
| renaissance technologies llc | 1,643,747 | $3.5M |
| dimensional fund advisors lp | 1,301,664 | $2.8M |
| blackrock, inc. | 1,106,840 | $2.4M |
| connor, clark & lunn investment management ltd. | 1,058,397 | $2.3M |
| mackenzie financial corp | 844,835 | $1.8M |
| marshall wace, llp | 836,266 | $1.8M |
| arrowstreet capital, limited partnership | 834,570 | $1.8M |
| bridgeway capital management, llc | 723,477 | $1.5M |
| goldman sachs group inc | 684,418 | $1.5M |
Showing top 10 of 101 institutional holders of Black Diamond Therapeutics, Inc.. Open the full 13F history after sign-in.
Short Interest
as of May 20, 2026- % of float
- 13.7%
- Days to cover
- 8.5
- Shares short
- 5,473,560
- Daily short volume
- -
Short percent of float and days-to-cover reflect reported short positioning. Daily short volume is the exchange-reported short share of a single day's trading volume and is noisier. See the most-shorted biotech ranking →
BDTX short interestFrequently asked questions
What is the AI investment thesis for Black Diamond Therapeutics, Inc.?
Black Diamond Therapeutics is a clinical-stage biopharmaceutical company focused on developing allosteric small molecule inhibitors targeting oncogenic mutations, with its lead candidate silevertinib (BDTX-1535) in Phase 2 trials for non-small cell lung cancer.
What is Black Diamond Therapeutics, Inc.'s lead drug candidate?
Black Diamond Therapeutics, Inc.'s most advanced tracked candidate is BDTX-1535 (Phase 2) for Epidermal growth factor receptor mutant (EGFRm) non-small cell lung cancer (NSCLC) and glioblastoma (GBM); includes treatment of metastatic EGFR C797S mutation-positive NSCLC without T790M whose disease has progressed on/after a third-generation EGFR TKI; Phase 2 cohorts in 2L/3L EGFRm NSCLC with non-classical driver mutations and acquired C797S, and a 1L cohort in non-classical EGFR mutations; development for EGFR altered GBM being evaluated..
What is Black Diamond Therapeutics, Inc.'s next catalyst?
Black Diamond Therapeutics, Inc.'s next tracked catalyst is a Phase2_Topline event — "Phase 2 Readout: silevertinib" — expected December 31, 2026.
Who is the CEO of Black Diamond Therapeutics, Inc.?
Dr. Mark A. Velleca M.D., Ph.D. is the chief executive officer of Black Diamond Therapeutics, Inc. (BDTX).
Where is Black Diamond Therapeutics, Inc. headquartered?
Black Diamond Therapeutics, Inc. (BDTX) is headquartered in Cambridge, MA, United States.
The AI overview and BioSniper Score are neutral, data-derived signals built from public SEC filings, ClinicalTrials.gov and FDA records — not investment advice.