Executive Summary

Enrollment completed in Phase 2 silevertinib (BDTX-1535) 1L non-classical EGFRm NSCLC (n=43); ORR and preliminary DOR readout guided for Q4 2025; company is exploring partnership options to support pivotal development in NSCLC and GBM and plans to seek FDA feedback on 1L registrational path in 1H 2026 when PFS is available .
Q2 EPS of $(0.19) beat S&P Global consensus by $0.06 (consensus $(0.2475)) on lower R&D and G&A; revenue was in line at $0 (consensus $0.0) .
Operating discipline continued: R&D fell to $9.3M and G&A to $4.1M, reflecting restructuring actions and focus on silevertinib; net loss improved YoY to $(10.6)M from $(19.9)M .
Liquidity solid: $142.8M cash, cash equivalents, and investments at 6/30/25; runway guided “into Q4 2027,” unchanged from Q1 post-Servier deal .

What Went Well and What Went Wrong

What Went Well
- Completed enrollment in Phase 2 1L non-classical EGFRm NSCLC (n=43), enabling ORR/DOR update in Q4 2025; management reiterated a partnership process to accelerate pivotal development: “exploring partnership opportunities to advance silevertinib into pivotal development” .
- Opex discipline: R&D down to $9.3M (vs $12.6M YoY) and G&A down to $4.1M (vs $9.6M YoY), attributed to workforce efficiencies, BDTX‑4933 out-licensing, and 2024 restructuring .
- EPS beat vs consensus driven by lower operating expenses; cash runway maintained into Q4 2027, de-risking near-term financing needs .
What Went Wrong
- Sequential optics tough: after $70.0M Q1 license revenue, Q2 had $0 revenue, swinging operating income from $54.5M (Q1) to a loss of $(13.4)M (Q2) .
- Regulatory timing pushed: earlier messaging targeted FDA feedback on pivotal path in H2 2025; now planned for 1H 2026 tied to availability of PFS, effectively extending the timeline .
- Continued net losses in periods without licensing inflows: Q2 net loss $(10.6)M despite Opex reductions; net cash used in operations of $9.2M in Q2 (vs $14.7M YoY) underscores dependence on external funding or BD milestones before pivotal trials .

Financial Results

Income Statement Snapshot (YoY and Seq)

Metric	Q2 2024	Q1 2025	Q2 2025
License Revenue ($M)	$0.0	$70.0	$0.0
R&D Expense ($M)	$12.6	$10.5	$9.3
G&A Expense ($M)	$9.6	$5.0	$4.1
Total Operating Expenses ($M)	$22.1	$15.5	$13.4
Income (Loss) from Operations ($M)	$(22.1)	$54.5	$(13.4)
Other Income (Expense), net ($M)	$2.2	$2.0	$2.9
Net Income (Loss) ($M)	$(19.9)	$56.5	$(10.6)
Diluted EPS ($)	$(0.36)	$0.98	$(0.19)

Notes: Q1 2025 included a $70.0M Servier license revenue; Q2 2025 had no revenue . Q2 2025 Opex reductions reflect workforce efficiencies, BDTX‑4933 out-licensing, and 2024 restructuring .

Cash and Liquidity

Metric	Dec 31, 2024	Mar 31, 2025	Jun 30, 2025
Cash, Cash Equivalents & Investments ($M)	$98.6	$152.4	$142.8
Net Cash from Ops (Quarter) ($M)	N/A	$53.4 provided	$(9.2) used
Runway Guide	Into Q4 2026	Into Q4 2027	Into Q4 2027

Versus S&P Global Consensus (Q2 2025)

Metric	Actual	Consensus	Surprise
Diluted EPS ($)	$(0.19)	$(0.2475)*	+$0.06
Revenue ($M)	$0.0	$0.0*	$0.0

Values with asterisks retrieved from S&P Global. EPS coverage: 4 estimates; Revenue coverage: 5 estimates.*

Segment/Revenue Mix

Revenue Component	Q2 2024	Q1 2025	Q2 2025
License Revenue ($M)	$0.0	$70.0	$0.0

No product revenue reported.

Operating KPIs (Biotech)

KPI	Q2 2024	Q1 2025	Q2 2025
R&D ($M)	$12.6	$10.5	$9.3
G&A ($M)	$9.6	$5.0	$4.1
Total Opex ($M)	$22.1	$15.5	$13.4
Net Income (Loss) ($M)	$(19.9)	$56.5	$(10.6)

Guidance Changes

Metric	Period	Previous Guidance	Current Guidance	Change
Cash Runway	Corporate	Into Q4 2027 (Q1’25)	Into Q4 2027 (Q2’25)	Maintained
FDA Feedback on 1L NSCLC Path	Program	H2 2025 (Q4’24)	1H 2026, when PFS is available (Q2’25)	Timing pushed
1L NSCLC Data (ORR/DOR)	Clinical	Initial Phase 2 data in Q2 2025 (Q4’24)	ORR and preliminary DOR in Q4 2025 (Q2’25)	Timing updated
Partnership for Silevertinib	Corporate	Seeking partners (Q4’24 restructuring backdrop)	Exploring partnerships for pivotal development (Q2’25)	Reinforced

No revenue, margin, or tax-rate guidance provided.

Earnings Call Themes & Trends

Note: A Q2 2025 earnings call transcript was not available in our document set; themes reflect company press releases.

Topic	Previous Mentions (Q4’24 and Q1’25)	Current Period (Q2’25)	Trend
BDTX‑1535 1L NSCLC Data Timing	Q4’24: Initial Phase 2 data Q2 2025 ; Q1’25: update in Q4 2025	ORR and preliminary DOR in Q4 2025	Shifted later, now consistent
FDA Pathway (1L)	Q4’24: seek FDA feedback H2 2025	Plan for FDA feedback 1H 2026 with PFS data	Timing pushed
Partnership Strategy	Q4’24: de-prioritize BDTX‑4933, seek partners	Exploring partnerships to advance pivotal development	Active BD focus
Cash Runway	Q4’24: into Q4 2026	Q1’25: into Q4 2027 (post-Servier) ; maintained in Q2’25	Improved, sustained
GBM Program	Q4’24: expansion expected Q1’25	Phase 0/1 expanded into newly diagnosed GBM in Q1’25	Progressing
Opex Discipline	Q4’24: restructuring	Q2’25: lower R&D/G&A YoY; reasons cited	Continued execution

Management Commentary

“With enrollment completed in our silevertinib Phase 2 trial for the treatment of newly diagnosed patients with EGFRm NSCLC, we look forward to sharing a clinical update in the fourth quarter of 2025. Given the evolving competitive and regulatory landscape, we are also exploring partnership opportunities to advance silevertinib into pivotal development and bring this potential best-in-class treatment to patients as quickly as possible.” — Mark Velleca, M.D., Ph.D., President & CEO .
Q2 financial framing emphasized disciplined spend: R&D down driven by “workforce efficiencies and outlicensing of BDTX‑4933,” G&A down due to “restructuring announced in October 2024” .

Q&A Highlights

We did not locate a Q2 2025 earnings call transcript in the company filings or document set; therefore, Q&A highlights and any on-call guidance clarifications are unavailable to summarize.

Estimates Context

EPS beat: $(0.19) actual vs $(0.2475) consensus; +$0.06 surprise (4 estimates)* .
Revenue: $0.0 actual vs $0.0 consensus (5 estimates); in line* .
Drivers of the beat: lower R&D and G&A vs prior year due to restructuring and portfolio focus (BDTX‑4933 out-licensed), partially offset by lack of licensing revenue in Q2 (vs $70.0M in Q1) .

Values with asterisks retrieved from S&P Global.*

Key Takeaways for Investors

Near-term catalyst path is intact: ORR and preliminary DOR from the 1L non-classical EGFRm NSCLC cohort (n=43) in Q4 2025; partnership newsflow possible as BD efforts are explicitly underway .
Regulatory clarity expected in 1H 2026 once PFS matures; timeline push from earlier H2 2025 expectation modestly extends pivotal start but ties to more robust efficacy data .
Cost discipline is working: sustained reductions in R&D and G&A shrink quarterly loss and helped deliver an EPS beat despite zero revenue in Q2 .
Liquidity is adequate into Q4 2027, limiting near-term financing risk; however, pivot to pivotal programs will likely require either a partner or additional capital over time .
Sequential comps are noisy due to Q1’s $70M license revenue; focus should be on Opex trajectory and clinical execution toward Q4 2025 data .
Trading setup: stock likely to trade on partnership headlines and any signals ahead of the Q4 2025 ORR/DOR disclosure; estimate revisions limited given zero revenue base and low EPS coverage breadth .

Citations

Q2 2025 8-K and Exhibit 99.1 press release:
Q2 2025 press release (company site):
Q1 2025 press release:
Q4 2024 press release:
2024 Restructuring release (context):

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