Longeveron Inc. (LGVN)·Q3 2025 Earnings Summary

Executive Summary

• Q3 revenue of $0.137M missed S&P Global consensus of $0.285M by ~52%; EPS of $(0.39) missed $(0.26) consensus, with widened loss vs both prior quarter and prior year as spending for CMC/manufacturing readiness and personnel increased . Consensus from S&P Global marked with an asterisk below.*
• Management pushed HLHS BLA timing to 2027 (from “late 2026”) to extend runway and sequence CMC spend; ELPIS II remains fully enrolled with top-line expected in Q3 2026 .
• Cash was $9.2M at 9/30 with runway “late into Q1 2026”; ATM capacity up to $10.7M; additional financing or partnerships remain a priority given run-rate losses .
• Manufacturing strategy advanced: proof‑of‑concept tech transfer runs at an external site completed; moving toward selecting a commercial CMO to enable BLA readiness while managing cash .

What Went Well and What Went Wrong

• What Went Well

  • ELPIS II for HLHS fully enrolled (40 patients) and on track for Q3’26 top-line; HLHS retains FDA Orphan, Fast Track, Rare Pediatric Disease designations .
  • Manufacturing/CMC execution: “strategic decision to pursue commercial manufacturing through a third-party CMO… successfully completed proof-of-concept manufacturing runs” .
  • Alzheimer’s program strengthened: CLEAR MIND Phase 2a data published in Nature Medicine; FDA alignment on a single pivotal Phase 2/3 acceptable for BLA; active partnership outreach .
  • Quote (CEO): “We have focused on disciplined execution… extend our runway into late Q1 and… structure our spending to sequentially deliver critical CMC and manufacturing milestones” .

• What Went Wrong

  • Material revenue shortfall: Q3 revenue $0.137M vs $0.773M YoY and $0.316M QoQ, driven by lower Bahamas Registry Trial participation and winding down of a contract manufacturing client .
  • Loss widened: Q3 net loss $(7.221)M vs $(4.419)M YoY and $(5.028)M QoQ; G&A and R&D rose on personnel, equity comp, and BLA‑enabling CMC activities .
  • BLA timeline extended to 2027 from late 2026 to preserve cash; management reiterated need for additional financing/partnerships and warned operations would need to be revised absent funding .

Financial Results

Actual vs S&P Global consensus (Q3 2025):

• Drivers: Management cited decreased participant demand in the Bahamas Registry Trial and reduced activity at a third‑party contract manufacturing client as the key revenue headwinds .

Segment revenue breakdown

Key operating and liquidity KPIs

Guidance Changes

Note: No revenue, margin, OpEx or tax-rate quantitative guidance provided in Q3 materials .

Earnings Call Themes & Trends

Management Commentary

• Strategic focus and cash discipline: “We have focused on disciplined execution… extend our runway into late Q1 and… structured our spending to sequentially deliver critical CMC and manufacturing milestones… [which] will push our potential full BLA filing from late 2026 into 2027.” – Interim CEO Thanh Pau .
• Manufacturing strategy: “Strategic decision to pursue commercial manufacturing through a third‑party CMO… initiated technology transfer activities and successfully completed proof‑of‑concept manufacturing runs… plan to begin larger-scale manufacturing campaigns… announce selected partner later this quarter.” – CTO Devin Blass .
• HLHS clinical rationale: ELPIS I showed “100% transplant-free survival up to five years” vs ~20% mortality in historical controls; ELPIS II is pivotal with top-line in Q3’26 .

Q&A Highlights

• Commercialization vs partnering in rare pediatrics: Company can self-commercialize a niche market but is actively evaluating U.S. and ex-U.S. partnerships to accelerate adoption and reduce commercial build costs, contingent on ELPIS II data .
• BLA timing and rolling submission: Full BLA by end-2026 no longer feasible given rephased CMC spend; rolling components may be discussed with FDA in future Type C meetings; database lock targeted for late July/August 2026 .
• M&A appeal: Management sees HLHS plus pipeline (AD, pediatric DCM) as attractive; open to structures that recognize full company value .
• Pricing/payer context: HLHS value proposition anchored in survival and hospitalization outcomes; Mesoblast’s pediatric cell therapy experience seen as a constructive analog for market receptivity .
• Regulatory acceleration: Monitoring new FDA initiatives but prioritizing existing designations (e.g., priority review voucher program continuity) to expedite access if ELPIS II is positive .

Estimates Context

• Q3 2025 results vs S&P Global consensus: Revenue $0.137M vs $0.285M*; EPS $(0.39) vs $(0.26)* – both misses. Prior quarter: Q2 revenue $0.316M vs $0.412M*, miss; EPS $(0.33) vs $(0.35), slight beat.
• Estimate breadth: 3 estimates on Q3 revenue and EPS; 4 on Q2 metrics.*
• Implication: Street likely lowers near-term revenue trajectories (Bahamas/contract manufacturing headwinds) and may widen 2026 cash needs pending financing/partnership visibility, while maintaining 2026 HLHS catalyst timing.

Values with an asterisk were retrieved from S&P Global consensus via GetEstimates.*

Key Takeaways for Investors

• Q3 printed a double miss vs consensus with materially lower top-line tied to Bahamas and contract manufacturing; operating losses widened on CMC/BLA readiness investments .
• The narrative remains catalyst‑driven: ELPIS II top-line in Q3’26 unchanged; however, full BLA now targeted in 2027 to prioritize cash runway—a modest de‑rating risk near term .
• Manufacturing risk is being managed via external CMO strategy with tech transfer POC complete—supportive for CMC readiness but contingent on capital .
• Liquidity is tight: $9.2M cash, runway late into Q1’26, ATM $10.7M; expect ongoing financing/partner news flow—watch for dilution vs non‑dilutive sources .
• Alzheimer’s remains a strategic option: FDA alignment on a single pivotal Phase 2/3 and publication strengthen partnering prospects; updates could be stock catalysts .
• Pediatric DCM provides a second rare cardiovascular opportunity (pivotal Phase 2 planned 2026, financing dependent), broadening optionality .
• Trading setup: Near‑term sentiment anchored to financing and partnering cadence; medium‑term thesis rests on HLHS pivotal readout timing, CMC execution, and sustained regulatory momentum .

Footnotes:

• S&P Global consensus/values sourced via GetEstimates.