Executive Summary

Q4 2024 showed disciplined OpEx control with net loss improving year over year to $15.99M vs $19.41M in Q4 2023, and flat sequentially vs Q3 2024 ($15.56M); net loss per share was $-0.28 vs $-0.34 a year ago .
Management extended cash runway to “into Q4 2026” on $98.6M year-end cash, cash equivalents and investments, helped by restructuring actions taken in October 2024; prior quarter guidance was “into Q2 2026” .
Pipeline timelines shifted: initial Phase 2 data for 1L non-classical EGFRm NSCLC moved from Q1 2025 to Q2 2025; updated Phase 2 data in recurrent EGFRm NSCLC moved to 2H 2025; FDA registrational-path feedback now planned for 2H 2025 (focus on newly diagnosed) .
Near-term stock catalysts remain clinical: 1L Phase 2 data (Q2 2025) and clarity on registrational strategy (2H 2025); restructuring-driven runway extension reduces near-term financing overhang and supports “wait-for-data” positioning .

What Went Well and What Went Wrong

What Went Well

YoY expense discipline: R&D fell to $12.30M (from $15.29M) and net loss improved to $15.99M (from $19.41M) in Q4, reflecting workforce efficiencies and portfolio focus on BDTX-1535 .
Cash runway extended: $98.6M year-end cash supports operations “into Q4 2026,” an improvement versus Q3’s “into Q2 2026” outlook .
Clear program prioritization: management reiterated strategic focus on BDTX-1535 with upcoming Phase 2 updates and a path to FDA dialogue on registrational strategy. “We continue to focus on advancing BDTX-1535…” — Mark Velleca, CEO .

What Went Wrong

Timeline slippage: initial 1L Phase 2 data moved from Q1 2025 (prior) to Q2 2025, and recurrent EGFRm NSCLC update moved from Q1 2025 to 2H 2025, pushing out catalysts and regulatory clarity .
G&A uptick in Q4: G&A of $5.98M rose vs $5.57M in Q4 2023, driven by one-time restructuring costs, partially offsetting R&D savings .
No commercial revenue reported; results are driven by OpEx and other income, keeping the story binary around clinical/regulatory milestones rather than fundamentals .

Financial Results

P&L (GAAP)

Metric	Q4 2023	Q3 2024	Q4 2024
Research & Development ($M)	$15.29	$12.91	$12.30
General & Administrative ($M)	$5.57	$5.22	$5.98
Total Operating Expenses ($M)	$20.86	$18.13	$18.28
Loss from Operations ($M)	$(20.86)	$(18.13)	$(18.28)
Total Other Income (Expense), net ($M)	$1.45	$2.57	$2.29
Net Loss ($M)	$(19.41)	$(15.56)	$(15.99)
Net Loss per Share (basic & diluted)	$-0.34	$-0.28	$-0.28
Weighted Avg. Shares (basic & diluted)	51,637,433	56,507,956	56,607,842

Notes: Company did not present a revenue line; press releases include only operating expenses, other income, and net loss in the consolidated statement of operations .

Balance Sheet Snapshot

Metric	Dec 31, 2023	Sep 30, 2024	Dec 31, 2024
Cash, Cash Equivalents & Investments ($M)	$131.40	$112.68	$98.58
Total Assets ($M)	$158.57	$137.90	$122.64
Total Stockholders’ Equity ($M)	$116.74	$97.43	$83.29

KPIs (Operating/Runway)

KPI	Q3 2024	Q4 2024
Cash Runway (management guidance)	Into Q2 2026	Into Q4 2026
Net Cash Used in Operations (FY)	n/a	$62.3M (FY 2024)

Segment revenue breakdown: not applicable; company reported no commercial revenue lines in presented financials .

Guidance Changes

Metric	Period	Previous Guidance	Current Guidance	Change
Cash runway	Company-level	Into Q2 2026 (Q3 2024)	Into Q4 2026 (Q4 2024)	Raised/extended
BDTX-1535: initial Phase 2 data (1L non-classical EGFRm NSCLC)	Program timing	Q1 2025 (prior)	Q2 2025	Delayed
BDTX-1535: updated Phase 2 data (recurrent EGFRm NSCLC)	Program timing	Q1 2025 (prior)	2H 2025	Delayed
FDA feedback on registrational path	Regulatory	Planned Q1 2025 meeting and feedback (recurrent)	Planning to solicit FDA feedback 2H 2025 (focus on 1L)	Delayed/shifted focus
GBM “window” trial expansion	Program timing	Not previously guided with date	Expansion to newly diagnosed GBM in Q1 2025	New item

Earnings Call Themes & Trends

Note: BDTX furnished an 8-K and press release; no earnings call transcript was provided in the furnished materials set .

Topic	Previous Mentions (Q2 2024 and Q3 2024)	Current Period (Q4 2024)	Trend
BDTX-1535 clinical execution	Q2: Phase 2 milestones on track; real-world NCM landscape; BBB penetration in GBM studies . Q3: Initial Phase 2 recurrent data; 200 mg dose selected; ORR 42% in osimertinib-resistant mutations .	1L data timing pushed to Q2 2025; recurrent update to 2H 2025 .	Progressing, timelines extended
Regulatory path	Q3: planned FDA meeting Q1 2025; potential registrational path (recurrent) in Q1 2025 .	Plan to solicit FDA feedback 2H 2025; emphasis on 1L path .	Delayed and refocused
Cash/runway	Q2: runway into Q4 2025 . Q3: extended into Q2 2026 (post-restructuring) .	Extended into Q4 2026 .	Improving runway
Corporate focus	Q3: restructuring to prioritize 1535; deprioritize 4933 .	Continued focus on 1535; runway reiterated .	Steady prioritization
GBM program	Q2: Phase 1 and “window” PK data supportive . Q3: EANO data supportive of expansion .	Expansion to newly diagnosed GBM in Q1 2025 .	Advancing

Management Commentary

“We continue to focus on advancing BDTX-1535 for the treatment of patients with EGFRm NSCLC and providing a clinical update on our Phase 2 trial for newly diagnosed patients in the second quarter of 2025.” — Mark Velleca, M.D., Ph.D., President & CEO .
“We also look forward to the expansion in the first quarter of 2025 of the investigator sponsored window of opportunity trial of BDTX-1535 into newly diagnosed glioblastoma patients with EGFR aberrations.” — Mark Velleca .
“BDTX-1535 is a well-tolerated oral TKI with the potential to benefit patients with EGFRm NSCLC across multiple lines of therapy.” — Mark Velleca (restructuring announcement) .

Q&A Highlights

Not applicable — the company furnished an 8-K and press release; no earnings call transcript was included in the furnished materials to extract Q&A detail .

Estimates Context

We attempted to retrieve S&P Global consensus for Q4 2024 (EPS and revenue) but consensus data was unavailable at the time of retrieval; as a result, we cannot assess beats/misses relative to Street consensus at this time.
Actual EPS (GAAP) for Q4 2024: $-0.28; revenue was not presented in the company’s reported statement of operations .
Where consensus estimates become available (S&P Global), we would anchor comparisons and flag any significant revisions implied for 2025 as new data arrives.

Key Takeaways for Investors

Runway extension to Q4 2026 reduces near-term financing risk and supports a catalyst-driven setup into mid/late-2025 data events .
Timeline push (Q1→Q2 2025 for 1L; Q1→2H 2025 for recurrent) delays key inflection points; watch for interim updates and any clarity on durability/ORR in 1L NCMs .
Expense discipline continues to improve YoY net loss; G&A elevation in Q4 tied to one-time restructuring costs should moderate going forward .
Focused strategy around BDTX-1535 and planned FDA engagement in 2H 2025 (1L path) frame the registrational narrative investors should underwrite .
GBM program expansion into newly diagnosed patients (Q1 2025) provides an incremental optionality vector but remains an early-stage contributor to valuation .
With no commercial revenue and the story driven by clinical outcomes, trading likely hinges on 1L Phase 2 readout in Q2 2025 and subsequent regulatory feedback timing .
Maintain vigilance for additional business development (e.g., partnerships for deprioritized assets) and operating updates that could further extend runway or alter cash burn trajectory .

Appendix: Prior Quarter Snapshots (for trend context)

Q3 2024 highlights: R&D $12.91M; G&A $5.22M; net loss $15.56M; cash $112.7M; runway into Q2 2026; initial Phase 2 recurrent data (ORR 42% in osimertinib-resistant mutations), 200 mg dose selected .
Q2 2024 highlights: R&D $12.56M; G&A $9.57M; net loss $19.91M; cash $123.0M; runway into Q4 2025; clinical updates and real-world data set-up into 2H 2024/2025 .

Black Diamond Therapeutics, Inc. (BDTX)·Q4 2024 Earnings Summary