Executive Summary

Q1 2025 EPS of $-0.28 beat Wall Street consensus of $-0.295; revenue was $0k vs $1,670k estimate, a miss given no collaboration revenue recognized .
Guidance lowered: 2025 cash burn cut to ~$150M (from ~$170M) and GAAP OpEx to ~$230M (from ~$250M); cash runway extended into 2H 2027, driven by targeted manufacturing reductions while preserving core capabilities .
ALPHA3 milestone shift: lymphodepletion selection and futility analysis moved to 1H 2026 due to site-related delays; momentum improving with >250 MRD screening consents and nearly half in the last three months; Canada sites to activate in Q2 2025 .
Near-term catalysts: ALLO-316 oral presentation at ASCO (June 1) with updated Phase 1 RCC data, and initiation of ALLO-329 RESOLUTION basket trial mid-2025; proof-of-concept timing moved to 1H 2026 to include clinical and biomarker data .

What Went Well and What Went Wrong

What Went Well

Strong operational discipline: runway extended to 2H 2027 and 2025 OpEx/cash burn lowered via targeted manufacturing reductions without impacting trial conduct; “we have extended our cash runway into the second half of 2027” .
ALPHA3 momentum: >250 patients consented for MRD screening as sites hit stride; nearly half consented in the last three months, and Canada activation begins in Q2 2025 .
Solid tumor progress: ALLO-316 Phase 1b cohort completed with oral presentation at ASCO; management highlights “meaningful activity in solid tumors” and Dagger technology supporting robust expansion/persistence .

What Went Wrong

ALPHA3 milestone delay: lymphodepletion selection and futility analysis pushed ~2 quarters to 1H 2026 due to site staffing and operational hurdles post-activation .
Revenue miss vs consensus: zero collaboration revenue in Q1 despite ~$1.67M consensus expectation, reflecting the non-revenue nature of programs and timing of collaboration activities .
Additional caution in autoimmune: RESOLUTION proof-of-concept move to 1H 2026 to include clinical data alongside biomarkers, delaying prior YE 2025 expectations .

Financial Results

P&L Snapshot (USD Thousands except EPS)

Metric	Q3 2024	Q4 2024	Q1 2025
Collaboration revenue - related party	$0	$0	$0
Research & development	$44,713	$44,972	$50,200
General & administrative	$16,333	$15,518	$14,991
Total operating expenses	$71,774	$60,490	$65,191
Interest and other income, net	$5,481	$994	$5,458
Net loss	$(66,293)	$(59,939)	$(59,733)
Net loss per share (EPS)	$-0.32	$-0.28	$-0.28

Balance Sheet Highlights (USD Thousands)

Metric	As of Sep 30, 2024	As of Dec 31, 2024	As of Mar 31, 2025
Cash, cash equivalents and investments	$403,385	$373,149	$335,549
Total assets	$589,120	$548,710	$507,982
Total liabilities	$125,372	$126,531	$122,589
Total stockholders’ equity	$463,748	$422,179	$385,393

Operating Cash Flow and Selected Metrics (USD)

Metric	Q3 2025	Q2 2025	Q1 2025
Cash from Operations	$(29,688,000)*	$(39,030,000)*	$(52,929,000)*
Total Operating Expenses	$44,901,000*	$54,437,000*	$65,191,000*
Cash and Equivalents	$37,815,000*	$52,332,000*	$42,455,000*
Values retrieved from S&P Global.*

Actual vs Consensus (S&P Global) – Q1 2025

Metric	Consensus	Actual
Primary EPS Consensus Mean	$-0.295	$-0.28
Revenue Consensus Mean ($USD Thousands)	1,670	0
Primary EPS - # of Estimates	4	—
Revenue - # of Estimates	12	—

KPIs and Program Execution

KPI	Q3 2024	Q4 2024	Q1 2025
ALPHA3 activated sites (US)	~30	40	nearly 50
Patients consented for MRD screening	—	—	>250; ~50% in last three months
ALPHA3 milestone timing	LD selection mid-2025	LD selection mid-2025; interim EFS 1H 2026; primary EFS YE 2026	LD selection + futility moved to 1H 2026
International expansion	—	—	Canada site activations in Q2 2025
ALLO-316 status	SITC/IKCS positive Phase 1 data	Phase 1b enrollment complete; mid-2025 data	Oral presentation at ASCO June 1
ALLO-329 status	IND targeted Q1 2025	IND cleared, RESOLUTION starts mid-2025; POC YE 2025	POC moved to 1H 2026; dual LD arms incl. no LD

Guidance Changes

Metric	Period	Previous Guidance	Current Guidance	Change
Cash runway	Corporate	Into 2H 2026	Into 2H 2027	Raised runway
Decrease in cash, cash equivalents & investments	FY 2025	~$(170)M	~$(150)M	Lower burn
GAAP Operating Expenses	FY 2025	~$250M incl. ~$50M SBC	~$230M incl. ~$45M SBC	Lower OpEx
ALPHA3 LD selection + futility	Trial milestone	Mid-2025	1H 2026	Delayed
ALLO-329 proof-of-concept	Program milestone	YE 2025	1H 2026	Delayed

Earnings Call Themes & Trends

Topic	Previous Mentions (Q3 2024)	Previous Mentions (Q4 2024)	Current Period (Q1 2025)	Trend
ALPHA3 site activation & momentum	~30 sites activated; LD selection mid-2025	40 sites; interim EFS 1H 2026; primary YE 2026	Nearly 50 sites; >250 MRD consents; Canada expansion	Improving engagement; broader footprint
Operational delays at sites	Not highlighted	Not highlighted	3–4 month lag post-activation due to staffing/ops issues	Identified and being mitigated
Lymphodepletion strategy (ALPHA3)	LD selection planned	Formal efficacy testing at interim; LD arm agnostic	LD selection + futility shifted to 1H 2026; evaluating data sharing	Timing pushed; framing improved
Regulatory environment (CBER)	—	—	CEO commentary on evidence-based approach; MRD as selection, EFS endpoint	Constructive stance
Autoimmune (ALLO-329)	IND targeted Q1 2025	IND cleared; mid-2025 start; POC YE 2025	POC to 1H 2026; dual LD arms incl. no LD; partnering openness	Added caution; broader data aim
Manufacturing & cost alignment	—	—	Targeted reductions; inventory sufficient; shelf-life robust	Efficiency focus

Management Commentary

CEO strategic framing: “We are executing on a strategy that is grounded in science, shaped by real-world insights, and supported by a platform purpose-built to scale... We have never been clearer about our path or more certain about the value we can deliver” .
On ALPHA3 delays and momentum: “There was a lag... consistent about 3 to 4-month delay... purely site-related... we now have patients being consented for screening... meeting initial assumptions” .
CMO on solid tumors: “ALLO-316... first allogeneic to demonstrate meaningful activity in solid tumors with just a single infusion” with Phase 1b expansion featured at ASCO .
CFO on runway and spend: “We’ve taken deliberate steps to extend our cash runway into the second half of 2027... targeted reductions in manufacturing operations to achieve key cost savings while maintaining core capabilities” .

Q&A Highlights

ALPHA3 enrollment funnel: >250 consents reflect top-of-funnel; conversion requires MRD-positive post-therapy; lag from consent to randomization due to treatment completion and logistics (2–4 weeks) .
Community vs academic sites: no clear difference in startup times; aggressive screening once online .
Interim and efficacy testing: DSMB interim in 1H 2026 will be a formal EFS hypothesis test with minimal alpha spend; potential statistical significance could accelerate regulatory dialogue .
Autoimmune strategy: dual arms with cyclophosphamide-only and no LD; willingness to partner given cash discipline; POC to include clinical outcomes and biomarkers .
Manufacturing inventory and stability: existing stock sufficient for trials; frozen stability “several years” with ongoing testing .

Estimates Context

EPS: Q1 2025 EPS beat consensus ($-0.28 vs $-0.295), aided by interest income ($5.5M) and disciplined OpEx; future consensus may lower full-year OpEx following updated guidance .
Revenue: Actual $0k vs $1,670k consensus; analysts may remove residual collaboration revenue assumptions given recent quarters’ minimal revenue .
Analyst coverage breadth: EPS estimates count was 4 in Q1; revenue estimates count 12, suggesting limited revenue visibility for near-term [GetEstimates].

Key Takeaways for Investors

Cost discipline is the key positive: lowered 2025 OpEx and cash burn plus runway to 2H 2027 reduces financing risk ahead of multiple milestones .
ALPHA3’s delay is execution-related, not strategy-related: site staffing/ops bottlenecks explain the shift; momentum indicators (consents, Canada expansion) are improving .
Solid tumor optionality: ASCO oral data on ALLO-316 could be a narrative catalyst; prior Phase 1 signals plus Dagger technology underpin potential partnership discussions .
Autoimmune program prudence: RESOLUTION POC timing pushed to include clinical outcomes; design innovation (no LD arm) is differentiation, with partnering optionality reducing capital intensity .
Near-term trading setup: Watch for ASCO readout and any additional ALPHA3 enrollment updates; estimate revisions likely lower OpEx and adjust ALPHA3 timing, potentially de-risking cash needs .
Risk checks: Dependence on trial execution (ALPHA3 accrual and MRD conversion), regulatory posture (CBER), and maintaining manufacturing efficiencies are key constraints .

All citations: Q1 2025 8-K press release and Selected Financial Data ; Q1 2025 earnings call transcript ; Q4 2024 press release ; Q4 2024 call ; Q3 2024 press release and Selected Financial Data ; ALLO-316 ASCO-related press releases . Values retrieved from S&P Global for starred items.

Allogene Therapeutics, Inc. (ALLO)·Q1 2025 Earnings Summary