Executive Summary

Q1 2025 EPS modestly beat a very light consensus: Diluted loss per share of $0.37 vs Wall Street consensus of -$0.38, a $0.01 beat; revenue remained non-existent for this pre-revenue biotech (consensus $0) . EPS consensus values from S&P Global.*
Operating discipline mixed: total operating expenses rose year over year, driven by higher R&D for the expanded DeFianCe Part B trial; G&A declined vs prior year. Cash fell to $32.7M, reflecting ~$14.5M operating cash outflow in the quarter .
Strategic pivot: management announced a ~50% workforce reduction to prioritize sirexatamab (DKN-01) in second-line CRC and advance FL-501 preclinically, and engaged a financial advisor to explore business development options—key potential catalysts alongside upcoming clinical data updates this quarter .
Clinical narrative strengthening: DeFianCe Part B continued to show statistically significant ORR and PFS benefits in DKK1-high and VEGF-naïve subgroups, supporting a registrational Phase 3 path; 42 patients remained on study (25 sirexatamab vs 17 control), suggesting further PFS maturation potential .

What Went Well and What Went Wrong

What Went Well
- Clinically meaningful efficacy signals in targeted subgroups: “statistically significant higher ORR and longer PFS” in DKK1-high and VEGF-naïve second-line CRC patients; management expects additional data updates in the quarter .
- Focused capital allocation: restructuring reduces workforce ~50% to concentrate resources on CRC and FL-501, potentially extending runway and sharpening execution .
- Positive preclinical progress for FL-501: extended half-life, reduced clearance, and strong anti-cachexia activity vs clinical-stage benchmarks in preclinical models, reinforcing best-in-class aspirations .
What Went Wrong
- Cash burn remains material: operating cash outflow of $14.5M drove cash down to $32.7M, highlighting financing/partnering needs for Phase 3 ambitions .
- Higher R&D expense year over year: R&D rose to $12.9M (+$1.6M YoY) on trial expansion and activity, pressuring losses (net loss $15.4M vs $13.8M YoY) .
- Limited near-term revenue visibility and market risks: company remains pre-revenue and cites risks including financing, Nasdaq compliance, and need for partnerships—potential overhangs until strategic actions or pivotal trial plans crystallize .

Financial Results

Income statement and balance sheet highlights (USD Millions, except per-share). Periods shown oldest → newest.

Metric	Q1 2024	Q3 2024	Q4 2024	Q1 2025
Net Loss ($)	$13.820	$18.176	$15.431	$15.435
Diluted EPS ($)	$(0.51)	$(0.44)	$(0.37)	$(0.37)
R&D Expense ($)	$11.299	$14.915	$13.112	$12.911
G&A Expense ($)	$3.526	$2.940	$3.013	$3.006
Total OpEx ($)	$14.825	$17.855	$16.125	$15.917
Cash & Equivalents ($)	$54.921	$62.823	$47.249	$32.713

Revenue and margins

Revenue: none reported (pre-revenue biotech) .
Margins (EBITDA, EBIT, Net Income): not meaningful due to no revenue .

Cash flow (USD Millions)

Metric	Q1 2024	Q3 2024	Q4 2024	Q1 2025
Cash used in Operating Activities ($)	$(15.516)	$(15.600)	$(15.512)	$(14.480)
Net Change in Cash ($)	$(15.722)	$(15.656)	$(15.574)	$(14.536)

Select clinical KPIs referenced in Q1 update

KPI	Q1 2025
Patients remaining on study drug (sirex vs control)	25 vs 17
DeFianCe Part B efficacy (reference data)	Statistically significant higher ORR and longer PFS in DKK1-high and VEGF-naïve subgroups

Estimate comparison (Q1 2025)

Metric	Consensus	Actual	Delta
EPS ($)	$(0.38)*	$(0.37)	+$0.01 (beat)
Revenue ($M)	$0.0*	None reported	—

*Values retrieved from S&P Global.

Guidance Changes

Metric	Period	Previous Guidance	Current Guidance	Change
Financial guidance (Revenue, EPS, OpEx, etc.)	FY2025	None provided	None provided	Maintained (no formal guidance)
Strategy/Programs	Ongoing	Broader pipeline resourcing	Prioritize sirexatamab (CRC) and FL-501 preclinically; workforce -50%	Refocus/Lowered spend
Business Development	Ongoing	—	Engaged financial advisor to explore BD options	New/Expanded

Earnings Call Themes & Trends

Note: No Q1 2025 earnings call transcript was available in our corpus; we searched LPTX for “earnings-call-transcript” in the quarter and found none. We relied on the Q1 press release and related disclosures.

Topic	Previous Mentions (Q3 2024, Q4 2024)	Current Period (Q1 2025)	Trend
R&D execution (sirexatamab)	Q3: Part B enrollment completed; data expected mid-2025 . Q4: Updated Part B showed higher ORR and longer PFS in DKK1-high and VEGF-naïve; Phase 3 supported .	Continued positive efficacy signals; data updates expected in the quarter .	Improving evidence base; Phase 3 path reiterated
Business development	Q4: Engaged leading financial advisor for sirexatamab .	Exploring BD opportunities to advance sirexatamab; advisor engaged .	Active partnering exploration
Cost actions/operating focus	—	Strategic restructuring; ~50% workforce reduction to prioritize CRC and FL-501 .	Increased cost discipline
FL-501 (GDF-15)	Q4: AACR abstract accepted; plan for clinical trial in 2026 .	Positive preclinical data presented at AACR (PK/clearance and anti-cachexia activity) .	Continued progress toward 2026 clinic entry
Regulatory/Phase 3 path	Q4: Registrational Phase 3 supported by data .	Phase 3 opportunity reiterated in CRC subgroups .	Consistent Phase 3 narrative

Management Commentary

“In this difficult market environment, we focused our resources to position Leap to advance sirexatamab in CRC and FL-501 preclinically… I would like to personally thank all of our colleagues who have been impacted by this decision…” — Douglas E. Onsi, President & CEO .
“With 42 patients currently remaining on study drug… we continue to be optimistic about the maturing dataset in the full population and look forward to upcoming data updates this quarter.” — Douglas E. Onsi .
On DeFianCe Part B: updated data “demonstrates significantly higher ORR and longer PFS” in DKK1-high and VEGF-naïve subgroups, supporting a registrational Phase 3 trial .

Q&A Highlights

No Q1 2025 earnings call transcript available in our document set; we searched for “earnings-call-transcript” for the quarter and found none. Management did host a KOL event focused on sirexatamab in second-line MSS CRC on April 23, 2025, indicating investor engagement on subgroup strategy and clinical positioning .

Estimates Context

EPS: Reported $(0.37) vs consensus $(0.38)—a $0.01 beat on minimal analyst coverage (1 estimate). Revenue: consensus $0; company reported no revenue, consistent with pre-revenue status . EPS and revenue consensus values from S&P Global.*
Coverage breadth remains limited (1 estimate), so estimate dispersion is minimal; near-term estimate revisions will likely hinge on upcoming DeFianCe data updates and clarity on Phase 3/BD pathways .
*Values retrieved from S&P Global.

Key Takeaways for Investors

Slight EPS beat on lean coverage; financials remain dominated by R&D investment and cash burn (~$14.5M operating outflow) .
Cash of $32.7M underscores the importance of partnering or financing ahead of Phase 3; restructuring (-50% workforce) helps conserve capital while focusing on highest-ROI programs .
Clinical de-risking continues in targeted CRC subgroups (DKK1-high, VEGF-naïve), a credible path to registrational development and potential accelerated approval strategies .
Near-term stock catalysts: additional DeFianCe data updates this quarter, BD developments, and any regulatory feedback on Phase 3 design .
Risk factors remain: pre-revenue status, dependence on external capital/partners, and listing/compliance considerations cited in forward-looking statements .
Trading setup: momentum sensitive to clinical update cadence and strategic alternative outcomes; downside buffered by cash, upside levered to subgroup efficacy durability and BD execution .

LEAP THERAPEUTICS, INC. (LPTX)·Q1 2025 Earnings Summary