Executive Summary

Q1 2025 revenue of $0.381M missed S&P Global consensus of $0.595M by ~36%; EPS of ($0.34) was roughly in line with ($0.33) consensus, with increased OpEx tied to BLA readiness driving a wider net loss year over year . Revenue consensus and EPS consensus from S&P Global*.
Management advanced key catalysts: ELPIS II (HLHS) ~95% enrolled, on track to complete enrollment in Q2 2025; AD program secured FDA alignment on a single, pivotal adaptive Phase 2/3 design with the potential for interim BLA submission if positive .
Cash and equivalents were $14.3M; runway now “late into Q3 2025,” lowered from prior “into Q4 2025,” as BLA-enabling CMC and manufacturing readiness spending ramps; the company intends to seek additional financing/partners/non‑dilutive funding .
Potential stock catalysts over the next 6–18 months: ELPIS II enrollment completion and 12‑month follow-up to data lock, BLA preparedness milestones, and AD partnering progress/launch of the pivotal adaptive study .

What Went Well and What Went Wrong

What Went Well
- HLHS program execution: ~95% enrollment with Q2 2025 completion targeted; FDA previously confirmed ELPIS II as pivotal and acceptable for traditional-approval BLA if positive . “ELPIS II has achieved approximately 95% enrollment… we expect to complete enrollment in the second quarter of this year” — CEO .
- AD regulatory clarity: FDA Type B meeting aligned on a single pivotal seamless adaptive Phase 2/3, with potential interim read to support BLA if positive .
- Manufacturing readiness plan articulated: CMC master plan and strategic options (internal capabilities vs CDMO) to minimize bottlenecks and meet BLA timeline .
What Went Wrong
- Top-line miss: Q1 revenue fell to $0.381M (down 30% YoY), driven by lower Bahamas Registry demand; this missed $0.595M consensus, with limited offset from contract manufacturing . Revenue consensus from S&P Global*.
- Operating intensity: G&A (+34% YoY) and R&D (+13% YoY) rose on personnel/equity comp and BLA readiness, expanding net loss to ($5.0M) vs ($4.1M) YoY .
- Runway shortened: now “late into Q3 2025” vs prior expectation “into Q4 2025,” reflecting accelerated CMC/manufacturing readiness; management flagged need for additional capital/non‑dilutive funding .

Financial Results

Sequential comparison (oldest → newest)

Metric	Q3 2024	Q4 2024 (calc)	Q1 2025	Q1 2025 Consensus
Revenue ($M)	$0.773	$0.603	$0.381	$0.595*
Gross Profit ($M)	$0.682	$0.530	$0.275	—
Gross Margin (%)	88.2% (calc)	87.9% (calc)	72.2% (calc)	—
Total OpEx ($M)	$5.331	$4.811	$5.456	—
Net Loss ($M)	($4.419)	($4.081)	($5.011)	—
Basic & Diluted EPS ($)	($0.34)	—	($0.34)	($0.33)*

Notes: Q4 2024 figures are derived from FY 2024 minus 9M 2024 where indicated (see citations). Consensus values marked with * are from S&P Global.

Year-over-year comparison (oldest → newest)

Metric	Q1 2024	Q1 2025	Q1 2025 Consensus
Revenue ($M)	$0.548	$0.381	$0.595*
Gross Profit ($M)	$0.329	$0.275	—
Gross Margin (%)	60.0% (calc)	72.2% (calc)	—
Net Loss ($M)	($4.058)	($5.011)	—
Basic & Diluted EPS ($)	($1.61)	($0.34)	($0.33)*

Revenue breakdown (oldest → newest)

Revenue Component ($M)	Q1 2024	Q3 2024	Q1 2025
Clinical Trial Revenue	$0.515	$0.210	$0.259
Contract Mfg Lease Revenue	$0.032	—	$0.006
Contract Mfg Revenue	$0.001	$0.563	$0.116
Total Revenue	$0.548	$0.773	$0.381

KPIs and balance sheet

KPI	Q1 2024	Q3 2024	Q1 2025
ELPIS II Enrollment Status	—	“>80%”	“~95%; complete in Q2’25”
Cash & Equivalents ($M)	—	$22.8	$14.3
Bahamas Registry Trial Rev ($M)	$0.515	$0.210	$0.259
Contract Manufacturing Rev ($M)	$0.001	$0.563	$0.116
EBITDA ($M)	—	—	($4.76)*

Notes: EBITDA for Q1 2025 marked * from S&P Global. Cash runway now “late into Q3 2025” (see Guidance) .

Guidance Changes

Metric	Period	Previous Guidance	Current Guidance	Change
Cash Runway	2025	“Into Q4 2025” (with caveat: ramping BLA enabling activities may impact projections)	“Late into Q3 2025”; spending to increase for CMC/manufacturing readiness; pursuing financing/partners/non-dilutive funding	Lowered runway; higher spend
ELPIS II Enrollment Completion	2024–25	Target YE’24; may slip to Q1’25	~95% enrolled; completion in Q2’25	Timeline reset later
HLHS BLA Timing	2026	Anticipated 2026 if ELPIS II positive	Reaffirmed 2026; prepare for rolling BLA	Maintained
AD Regulatory Pathway	2025	Anticipated late Q1’25 FDA meeting on paths	FDA alignment on single pivotal adaptive Phase 2/3; potential BLA at interim if positive	De‑risked path

Earnings Call Themes & Trends

Topic	Q3 2024	Q4 2024	Q1 2025	Trend
HLHS (ELPIS II) status	>80% enrolled; FDA confirmed pivotal, endpoints aligned	>90% enrolled; 3 patients remaining; composite endpoint under discussion with FDA	~95% enrolled; completion Q2’25; 12‑month follow-up to data lock	Steady progress; clarity improving
AD program	CLEAR MIND data highlighted; plan for FDA meeting	Planned March FDA meeting; exploring accelerated path	FDA alignment on single pivotal adaptive Phase 2/3 with interim BLA path	Positive regulatory momentum
CMC/BLA readiness	Hiring CTO; BLA-enabling focus flagged	CMC master plan; major 2025 investment	Strategic options (internal vs CDMO), aim to minimize delay/cost	Execution ramping
Commercialization (HLHS)	—	Small focused field force (<15 FTE) feasible	12 centers account for ~80% surgeries; 4–5 reps likely	Building commercial case
Financing/runway	Cash sufficient through Q4’25 (pre‑ramp)	Reiterate need for added spend and financing in 2025	Runway “late into Q3’25”; plans to raise capital/seek non‑dilutive funding	Runway shortened; financing overhang

Management Commentary

“ELPIS II has achieved approximately 95% enrollment, and we expect to complete enrollment in the second quarter of this year.” — CEO
“We reached foundational alignment… for a single, pivotal seamless adaptive Phase 2/3 clinical trial [in AD]… FDA agreed to consider a BLA submission based on positive interim results from this planned single study.” — CEO
“Our CMC… plan is focused on meeting our BLA timeline without delays at the lowest cost… exploring commercial manufacturing options… internal capabilities… or contracting… to a CDMO.” — CTO
“Our cash and cash equivalents as of March 31, 2025, were $14.3 million… we believe [they] will fund… late into the third quarter of 2025… we intend to seek additional financing… and/or non‑dilutive funding options.” — CFO
“One lot of laromestrocel… is enough to produce at least 1,500 doses… we believe [yields] will be able to supply the drug commercially.” — CTO (Q&A)

Q&A Highlights

HLHS market/adoption: Management estimates ~1,000 U.S. births annually; after Stage 1 survival and excluding select comorbidities, penetration could reach ~65%, implying a sizable opportunity; enrollment challenges seen as typical for ultra-rare settings .
Regulatory dynamics: No indications CBER leadership changes would impact BLA; team focused on submitting a “buttoned-up” package; PRV eligibility depends on reauthorization (management engaged with advocacy; cautiously optimistic) .
Manufacturing strategy: Evaluating CDMO vs internal; current yields suggest 1 lot ≈ 1,500 doses; ramping GMP systems and staffing; Alzheimer’s clinical supply would require commercial-level facilities/partner/CDMO .
Pricing/value-based framing: Referenced orphan precedents (e.g., pricing in seven figures in other cell/gene settings) and potential value-based constructs given mortality/hospitalization endpoints, but no definitive pricing yet .
Commercial build: Concentrated surgeon base (<50), with ~80% of Glenn procedures at the 12 trial centers; field force likely 4–5 reps, total commercial org <15 FTEs .

Estimates Context

Revenue missed consensus: $0.381M actual vs $0.595M consensus (miss ~$0.21M; ~36%); EPS modestly below: ($0.34) actual vs ($0.33) consensus (miss ~$0.01). Actuals from press release ; consensus values from S&P Global*.
Street coverage is thin (4 estimates for both revenue and EPS), increasing potential for estimate volatility as program milestones approach*.
Given elevated 2025 OpEx for CMC/BLA readiness, Street models may need to reflect higher near-term cash burn and shortened runway; revenue cadence likely remains opportunistic (registry and CDMO) until potential HLHS commercialization .

Consensus detail (Q1 2025): Primary EPS Consensus Mean = ($0.3275); Revenue Consensus Mean = $594,500; # of Estimates: 4 (EPS), 4 (Revenue)*.

Key Takeaways for Investors

Near-term catalyst path is clear: ELPIS II enrollment completion in Q2’25; 12‑month follow-up to top-line in mid‑2026; BLA preparation underway targeting 2026 filing if positive .
Regulatory de-risking in AD: FDA alignment on a single pivotal adaptive Phase 2/3 with potential interim BLA creates differentiated partnering optics vs crowded AD pipeline .
Financing overhang likely: Runway now “late into Q3’25” amid rising CMC/manufacturing readiness spend; expect capital raise(s) and pursuit of non‑dilutive funding/partnerships in 2025 .
Commercial leverage if approved: Concentrated prescriber base and high-volume trial centers should enable a small, focused launch footprint in HLHS .
Manufacturing scalability: Yield per lot (≈1,500 doses) and CDMO optionality help mitigate supply risk; Alzheimer’s scale would require commercial-capable facilities/partner .
Q1 miss driven by registry demand softness; watch revenue variability from CDMO and registry while core value drivers are clinical/regulatory milestones .
Stock likely most sensitive to: (1) ELPIS II operational milestones/data cadence, (2) AD partnership newsflow, and (3) financing terms/overhang resolution .

Additional detail and sources:

First Quarter 2025 financials and business update (press release)
8‑K Item 2.02 and Exhibit 99.1 (press release embedded)
Q1 2025 earnings call transcript (prepared remarks and Q&A)
FY 2024 results press release (for prior-quarter derivations and context)
Q3 2024 results press release and transcript (trend analysis)

Estimates marked with * are Values retrieved from S&P Global.

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