Black Diamond Therapeutics, Inc.
BDTX evidence brief
What we can confirm
- BioSniper Score:
- 6.7 / 10
- Market Cap:
- $113.8M
- Lead Asset:
- BDTX-1535 (Phase 2)
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, Inc. (BDTX) is a clinical-stage biopharmaceutical company developing precision oncology therapies, primarily focused on its lead irreversible EGFR inhibitor silevertinib for non-small cell lung cancer and glioblastoma, with no approved products or product revenue to date.
Key risk: No product revenue
BioSniper Score
Based on 4 of 6 signals
Financial data as of Jun 30, 2026.
Tracking 4 pipeline candidates · 24 clinical trials · 1 catalyst for Black Diamond Therapeutics, Inc..
Black Diamond Therapeutics, Inc. (BDTX) is a clinical-stage biopharmaceutical company developing precision oncology therapies, primarily focused on its lead irreversible EGFR inhibitor silevertinib for non-small cell lung cancer and glioblastoma, with no approved products or product revenue to date.
- Lead candidate silevertinib (BDTX-1535) is a brain-penetrant, irreversible EGFR MasterKey inhibitor in Phase 2 trials for EGFR-mutant NSCLC and glioblastoma [pipeline].
- Cash, cash equivalents, and investments were $118.3 million as of March 31, 2026, expected to fund operations into the second half of 2028 [news · 2026-05-07].
- The company reported an accumulated deficit of $483.7 million as of June 30, 2026, and has not generated any product revenue [sec_mda · as of 2026-08-05].
- A Phase 3 trial for silevertinib in glioblastoma is scheduled to start on December 1, 2026 [catalyst].
- BDTX-4933 was outlicensed to Servier Pharmaceuticals in March 2025, providing a $70.0 million upfront payment [sec_mda · as of 2026-05-07].
What works
- Silevertinib is designed to potently and selectively inhibit a broad range of oncogenic EGFR mutations while sparing wild-type EGFR, with brain penetration for potential CNS activity [pipeline].
- Cash runway extends into the second half of 2028, providing financial flexibility for ongoing clinical development [news · 2026-05-07].
- The outlicense of BDTX-4933 to Servier generated a $70.0 million upfront payment, validating the platform and providing non-dilutive capital [sec_mda · as of 2026-05-07].
What to weigh
- The company has no approved products and has never generated product revenue; profitability depends entirely on successful development and commercialization [sec_mda · as of 2026-05-07].
- Accumulated deficit reached $483.7 million as of June 30, 2026, reflecting sustained R&D spending without offsetting product sales [sec_mda · as of 2026-08-05].
- Silevertinib faces significant clinical and regulatory risk; the Phase 3 glioblastoma trial is not expected to yield an interim PFS analysis until the first half of 2028 [sec_mda · as of 2026-05-07].
- The company expects expenses to increase substantially as it advances silevertinib through later-stage trials and builds commercial infrastructure [sec_mda · as of 2026-08-05].
From the filings
Quoted directly from source documents.
Silevertinib is a brain-penetrant irreversible EGFR inhibitor in Phase 2 for NSCLC and GBM.
“Irreversible EGFR MasterKey inhibitor that potently and selectively inhibits families of oncogenic EGFR mutations while sparing wild-type EGFR; brain-penetrant small molecule”
Pipeline
Cash position as of March 31, 2026 was $118.3 million, funding into 2H 2028.
“Cash, cash equivalents, and investments of $118.3 million as of March 31, 2026, expected to be sufficient to fund operations into 2H of 2028”
News · May 7, 2026
Accumulated deficit as of June 30, 2026 was $483.7 million.
“June 30, 2026, we had an accumulated deficit of $483.7 million.”
SEC MD&A · August 5, 2026
Catalyst timeline
- 2026-12-01 · Phase3_Start — Phase 3 trial of silevertinib in glioblastoma begins; primary endpoint is PFS by BICR, with a planned futility analysis and interim PFS analysis expected in first half 2028.
Risks & what to watch (3)›
Key risks
- No product revenue — Company has no approved products and has never generated product revenue; all funding depends on partnerships or capital raises [sec_mda · as of 2026-05-07].
- Clinical trial execution — Phase 3 glioblastoma trial interim PFS analysis not expected until first half 2028, leaving a long period without pivotal data [sec_mda · as of 2026-05-07].
- Accumulated deficit — Accumulated deficit of $483.7M as of June 30, 2026, with expenses expected to increase [sec_mda · as of 2026-08-05].
What to watch
- Oral presentation of silevertinib Phase 2 data in frontline EGFRm NSCLC at the 2026 ASCO Annual Meeting [news · 2026-05-07].
- Initiation of the Phase 3 glioblastoma trial on December 1, 2026 [catalyst].
- Potential partnership opportunities to advance silevertinib into pivotal development [sec_mda · as of 2026-05-07].
- Interim PFS analysis from the Phase 3 glioblastoma trial anticipated in the first half of 2028 [sec_mda · as of 2026-05-07].
Sources: Catalysts · News · Pipeline · SEC MD&A · Generated October 11, 2026 · How we verify sources →
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Evidence & data
Score breakdownBased on 4 of 6 signals · derived from public data
Cash runway data unavailable
D/E 0.30 · 0% dilution
Lead: Phase 2
4 candidates
1 upcoming, next in ~48d
No insider transactions in the last 180 days
Catalysts
Pipeline
Regulatory
Financials
Institutional Holdings
Source: SEC Form 13F · as of Mar 2026Institutional holders
103
Total value held
$54.2M
| Holder | Shares | Value |
|---|---|---|
| nea management company, llc | 4,448,757 | $9.5M |
| 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 |
Showing top 10 of 103 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, Inc. (BDTX) is a clinical-stage biopharmaceutical company developing precision oncology therapies, primarily focused on its lead irreversible EGFR inhibitor silevertinib for non-small cell lung cancer and glioblastoma, with no approved products or product revenue to date.
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 Phase3_Start event — "Phase3_Start: PH Weighted Chemical Exchange Saturation Transfer Based Surgical Resections of Glioblastoma" — expected December 1, 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.