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CAPRICOR THERAPEUTICS, INC. (CAPR)·Q2 2025 Earnings Summary

Executive Summary

  • Q2 2025 results were weak: revenue $0.00 vs $3.97M prior-year and net loss widened to $25.9M ($-0.57 EPS), driven by elevated R&D and G&A; cash was $122.8M, guiding runway into Q4 2026 .
  • Regulatory update: following receipt of a CRL, a Type A FDA meeting was scheduled; all PLI “483” observations were resolved/accepted by FDA, and Capricor plans a BLA resubmission potentially supported by HOPE-3 data (topline expected Q4 2025) .
  • The quarter missed Wall Street: EPS $-0.57 vs consensus $-0.4689 and revenue $0.00 vs $0.778M; stock fell ~13.84% after-hours on the print to $8.22, reflecting concern over the reset regulatory timeline and higher spend .
  • Pipeline: FDA cleared IND for StealthX exosome vaccine; Phase 1 initiated by NIAID under Project NextGen; management emphasized platform partnering potential .

What Went Well and What Went Wrong

What Went Well

  • FDA manufacturing readiness: “the FDA has now accepted all 483 observations noted in our Pre-License Inspection (PLI), marking a major milestone in our regulatory progress and commercial manufacturing readiness” .
  • StealthX platform clinical entry: FDA IND cleared; first subjects dosed in Phase 1 by NIAID, advancing the exosome platform and potential for strategic partnerships .
  • Liquidity: cash, cash equivalents and marketable securities were $122.8M; runway guided into Q4 2026 .

What Went Wrong

  • Top-line and EPS miss: Q2 revenue $0.00 vs consensus $0.778M*; EPS $-0.57 vs consensus $-0.4689*; both missed Street expectations .
  • Cost inflation: total operating expenses rose to $27.7M from $15.6M YoY (+78%), driven by R&D ($22.0M) and G&A ($5.7M) .
  • Regulatory setback: receipt of a CRL reset the path/timing to approval and prompted a Type A FDA meeting and potential BLA resubmission supported by HOPE-3 data .

Financial Results

Quarterly P&L Summary

MetricQ4 2024Q1 2025Q2 2025
Revenue ($USD)$11.13M $0.00 $0.00
Total Operating Expenses ($USD)$18.83M $24.98M $27.72M
Net Loss ($USD)$7.12M $24.39M $25.91M
Diluted EPS ($)$-0.16 $-0.53 $-0.57

Q2 Year-over-Year

MetricQ2 2024Q2 2025
Revenue ($USD)$3.97M $0.00
Total Operating Expenses ($USD)$15.56M $27.72M
Net Loss ($USD)$10.99M $25.91M
Diluted EPS ($)$-0.35 $-0.57

Actual vs Estimates (Q2 2025)

MetricActualConsensusSurprise
Revenue ($USD)$0.00 $0.78M*-$0.78M; bold miss
Diluted EPS ($)$-0.57 $-0.4689*-$0.1011; bold miss

Values retrieved from S&P Global.

KPIs and Operating Detail

KPIQ1 2025Q2 2025
Cash, Cash Equivalents & Marketable Securities ($USD)$144.78M $122.80M
R&D Expense ($USD)$18.92M $22.05M
G&A Expense ($USD)$6.07M $5.67M
Weighted Avg Shares (Basic & Diluted)45.64M 45.71M

Guidance Changes

MetricPeriodPrevious GuidanceCurrent GuidanceChange
Cash RunwayCorporateSufficient into 2027 Sufficient into Q4 2026 Lowered
Regulatory Path (Deramiocel BLA)2025Priority review; PDUFA target Aug 31, 2025 CRL received; Type A meeting scheduled; plan to resubmit BLA; HOPE-3 topline Q4 2025 may be supportive Reset/Changed
HOPE-3 EndpointTrial designNot specified as part of BLA; HOPE-3 not requested by FDA for BLA Protocol amendment submitted to designate LVEF as primary endpoint Clarified
Manufacturing ReadinessPre-approvalPre-approval planning ongoing All PLI “483” observations resolved/accepted by FDA Improved

Earnings Call Themes & Trends

TopicPrevious Mentions (Q4’24 / Q1’25)Current Period (Q2’25)Trend
FDA Review / ApprovalPriority review; PDUFA Aug 31, 2025; mid-cycle: no significant deficiencies; AdCom planned CRL received; Type A meeting this week; planning BLA resubmission, potentially with HOPE-3 support From clear path to reset/uncertainty
Manufacturing / PLIPreparing for pre-approval inspection All PLI 483 observations resolved/accepted by FDA Strengthened
HOPE-3 Phase 3Not part of BLA; ongoing enrollment and skeletal muscle function focus 12-month period completed; topline Q4 2025; LVEF proposed as primary endpoint Progressing to key data
Exosome Platform (StealthX)Selected for Project NextGen; Phase 1 planned Q3 2025 IND cleared; Phase 1 initiated; management highlights partnering potential Advancing clinically
Financials / OpEx DisciplineGrowing OpEx in 2024 for manufacturing and commercialization readiness R&D and G&A elevated; cash runway into Q4 2026 Spend elevated, runway adequate

Management Commentary

  • “We remain steadfast in our mission to deliver the first approved therapy for Duchenne cardiomyopathy… While the receipt of a CRL was a setback, we are working diligently to define a clear regulatory path forward… We are fully prepared to supplement the BLA with HOPE-3 data as needed, with topline results expected in the fourth quarter of 2025” — Linda Marbán, CEO .
  • “The FDA has now accepted all 483 observations noted in our Pre-License Inspection (PLI), marking a major milestone in our regulatory progress and commercial manufacturing readiness” .
  • On StealthX: “the FDA’s clearance of the IND… marks the first clinical entry for our exosome platform… our broader goal is to advance StealthX™ into therapeutic applications… may lay the foundation for future strategic partnerships” .
  • “First subjects have been dosed in a Phase 1 clinical trial evaluating StealthX™… funded by NIAID under Project NextGen” .

Q&A Highlights

  • Type A meeting timing and feedback: management confirmed the Type A meeting “this week,” with written feedback expected before market updates; focus is on clarifying the resubmission path and timeline .
  • HOPE-3 endpoint: Capricor is seeking FDA agreement to designate LVEF as the primary efficacy endpoint in HOPE-3; management expects the topic to be addressed in the Type A meeting .
  • Exosome platform strategy: near-term vaccine readouts guided by NIAID; management reiterated business development/partnership potential and therapeutic payload delivery as the longer-term focus .
  • Ex-U.S. pathways: analyst questions referenced potential UK IRP; management indicated interest but remains focused on U.S. regulatory clarity first .

Estimates Context

  • Q2 2025 results vs consensus: EPS $-0.57 (actual) vs $-0.4689* (miss); revenue $0.00 (actual) vs $0.78M* (miss) .
  • Near-term consensus: Q3 2025 EPS $-0.5475*; Q3 revenue $0.48M*; EBITDA $-26.8M* (Street implies continued losses, modest revenue) — suggests estimates may need to edge lower on revenue unless milestone inflows occur; EBITDA largely tracks higher OpEx [Values retrieved from S&P Global].

Values retrieved from S&P Global.

Key Takeaways for Investors

  • Regulatory is the key catalyst: written outcomes from the Type A meeting will frame timing and content of the BLA resubmission and whether HOPE-3 support is required; expect stock sensitivity to that update .
  • Manufacturing de-risking: resolution of all PLI “483s” reduces pre-approval manufacturing risk and supports commercial readiness if/when approval is secured .
  • Cost discipline vs runway: OpEx elevated (R&D $22.0M in Q2), but cash runway into Q4 2026 provides time to execute; watch quarterly burn trend and any updates to runway .
  • HOPE-3 data in Q4 2025 is an important readout: agreement on LVEF as primary endpoint could strengthen the evidentiary package; timing and quality of topline will be pivotal .
  • Exosome platform optionality: first-in-human StealthX study under NIAID broadens strategic possibilities; partnerships could offset cash burn and diversify risk .
  • Near-term trading: Q2 miss and CRL drove a negative reaction; the next directional move likely hinges on Type A feedback and any clarity on resubmission timelines .
  • Medium-term thesis: if regulatory path is clarified and HOPE-3 supports the BLA, manufacturing readiness and U.S./Japan commercialization via NS Pharma position Deramiocel for potential first-in-class approval in DMD cardiomyopathy .