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Black Diamond Therapeutics, Inc. (BDTX)·Q3 2025 Earnings Summary

Executive Summary

  • Q3 2025 EPS of $-0.15 beat S&P Global consensus of $-0.23 by ~$0.08; revenue was $0, consistent with expectations for a development-stage biotech . EPS consensus values from S&P Global.*
  • Operating discipline continued: R&D fell to $7.4M and G&A to $3.5M, driving net loss improvement to $8.5M from $15.6M YoY .
  • Cash, cash equivalents, and investments were $135.5M at quarter-end, with runway maintained into Q4 2027, supporting upcoming data and regulatory milestones .
  • Near-term catalyst: management plans to disclose ORR and preliminary duration-of-treatment data from the 43-patient Phase 2 silevertinib trial later this quarter (Q4 2025), with PFS in 1H 2026—key stock-mover events .

What Went Well and What Went Wrong

What Went Well

  • EPS beat vs consensus, reflecting lower OpEx and higher other income; diluted EPS of $-0.15 vs S&P Global consensus $-0.23 . Consensus values from S&P Global.*
  • Cost discipline: R&D down to $7.4M and G&A to $3.5M (both down meaningfully YoY), narrowing net loss to $8.5M from $15.6M YoY .
  • Clear clinical and regulatory path: “We are looking forward to sharing a clinical update later this quarter… while PFS data is expected in the first half of 2026.” – Mark Velleca, CEO .

What Went Wrong

  • No product revenue; Q3 license revenue was $0, keeping margins non-meaningful and valuation hinging on clinical/regulatory progress .
  • Cash declined sequentially to $135.5M (from $142.8M in Q2 and $152.4M in Q1) as the company invests toward pivotal readiness .
  • Competitive/regulatory complexity remains: management continues to explore partnerships to advance pivotal development amid an evolving landscape in EGFRm NSCLC/GBM .

Financial Results

MetricQ3 2024Q1 2025Q2 2025Q3 2025
License Revenue ($USD Millions)$0.0 $70.0 $0.0 $0.0
EBIT (Income/Loss from Operations, $USD Millions)$(18.13) $54.53 $(13.42) $(10.98)
Net Income (Loss) ($USD Millions)$(15.56) $56.54 $(10.56) $(8.50)
Diluted EPS ($USD)$(0.28) $0.98 $(0.19) $(0.15)
R&D Expense ($USD Millions)$12.91 $10.51 $9.32 $7.44
G&A Expense ($USD Millions)$5.22 $4.96 $4.10 $3.54
Cash, Cash Equivalents & Investments ($USD Millions)N/A$152.4 $142.8 $135.5

Notes:

  • Margins (gross/EBIT margin) are not meaningful given $0 revenue in Q3; EBIT shown for operating progress .
  • Q1 revenue reflects $70.0M upfront from the Servier licensing agreement for BDTX-4933 .

Consensus vs Actual (Q3 2025):

MetricConsensusActual
EPS ($USD)$-0.23*$-0.15
Revenue ($USD Millions)$0.0*$0.0
EPS - # of Estimates6*N/A
Revenue - # of Estimates7*N/A

Values retrieved from S&P Global.*

Guidance Changes

MetricPeriodPrevious GuidanceCurrent GuidanceChange
Cash runwayFY 2025Sufficient into Q4 2027 (Q1/Q2 guidance) Sufficient into Q4 2027 (Q3 reaffirmed) Maintained
Clinical data (ORR + prelim duration)Q4 2025On track for Q4 2025 (Q1/Q2) “Later this quarter” (Q4 2025) Maintained/clarified timing
PFS readout (Phase 2)1H 2026Plan for FDA feedback timing updated to 1H 2026 (Q2) PFS data expected 1H 2026; intend to solicit FDA feedback then Clarified timeline
Partnership exploration (NSCLC/GBM)OngoingExploring partnership (Q2) Continues to explore partnership opportunities Maintained

Earnings Call Themes & Trends

No Q3 2025 earnings call transcript was located; themes are synthesized from earnings press releases.

TopicPrevious Mentions (Q1 2025)Previous Mentions (Q2 2025)Current Period (Q3 2025)Trend
R&D execution (silevertinib)Enrollment ongoing; Q4 2025 clinical update planned Enrollment completed (n=43); Q4 update confirmed ORR + prelim duration “later this quarter” Progressing to data disclosure
Regulatory path (NSCLC)Plan to solicit FDA feedback Q4 2025 Plan shifted to 1H 2026 with PFS data Intent to solicit FDA feedback in 1H 2026 Timeline refined/extended
Partnership strategyNot highlightedExploring partnerships to advance pivotal dev. Continues to explore partnerships (NSCLC/GBM) Ongoing
Cash runway$152.4M; runway to Q4 2027 $142.8M; runway to Q4 2027 $135.5M; runway to Q4 2027 Stable runway; sequential cash decline
GBM programPhase 0/1 expansion initiated; AACR poster supportive Partnership exploration includes GBM GBM remains part of partnering dialogue Continuing

Management Commentary

  • “We are looking forward to sharing a clinical update later this quarter from our silevertinib Phase 2 trial in newly diagnosed patients with EGFRm NSCLC. The update will include ORR and preliminary duration of treatment data, while PFS data is expected in the first half of 2026.” – Mark Velleca, M.D., Ph.D., President and CEO .
  • The company “continues to explore partnership opportunities in NSCLC and glioblastoma (GBM) to advance silevertinib into pivotal development” .
  • Intends to solicit FDA feedback on a potential registrational path when PFS data becomes available in 1H 2026 .

Q&A Highlights

  • No Q3 2025 earnings call transcript was available; no formal Q&A to report. Management emphasized timing and scope of the upcoming data release and partnership exploration in written materials .

Estimates Context

  • EPS beat: Q3 2025 diluted EPS of $-0.15 vs S&P Global consensus $-0.23 (6 estimates), a ~$0.08 beat driven by lower OpEx and higher net other income . Consensus values from S&P Global.*
  • Revenue in line: Consensus $0.0 vs actual $0.0, consistent with the pre-commercial stage of development . Consensus values from S&P Global.*
  • Near-term estimate revisions likely to focus on OpEx trajectory and timing/probability of pivotal initiation post-PFS; EPS dispersion may narrow post-ORR disclosure later this quarter .

Key Takeaways for Investors

  • The quarter was operationally strong: narrowed net loss and an EPS beat despite zero revenue—reflecting disciplined cost controls and some other income tailwinds .
  • Capital runway to Q4 2027 is intact, enabling the company to reach key clinical and regulatory milestones without near-term financing, a positive for risk-adjusted valuation .
  • The upcoming ORR/prelim duration read for silevertinib in 1L non-classical EGFRm NSCLC (n=43) is the key trading catalyst; strong ORR could support partnership momentum and clarity on registrational path .
  • Regulatory timeline refined: PFS in 1H 2026 followed by FDA feedback—investors should watch for alignment on pivotal design and comparator, which will drive the medium-term thesis .
  • Partnership exploration remains a strategic lever; any announced deal could de-risk pivotal execution and extend cash runway, potentially re-rating the stock .
  • Sequential cash declines (Q1→Q2→Q3) are expected as development progresses; monitoring OpEx trends remains essential, especially as the company approaches data and potential pivotal preparation .
  • With no product revenue, valuation hinges on clinical outcomes and regulatory clarity—data quality and durability signals (ORR, duration, brain penetration) will be decisive for medium-term positioning .