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CAPRICOR THERAPEUTICS, INC. (CAPR)·Q3 2025 Earnings Summary

Executive Summary

  • Q3 2025 delivered no revenue and wider losses as Capricor invested ahead of pivotal HOPE-3 data; cash, cash equivalents and marketable securities ended at $98.6M, with runway into Q4 2026 .
  • EPS modestly beat consensus by ~$0.01 (actual -$0.54 vs -$0.55 estimate), while revenue missed modest expectations (actual $0 vs $0.48M estimate), reflecting the end of prior contract revenue recognition in 2024 .*
  • Regulatory path clarified: following a Type A meeting, FDA supported submission of HOPE-3 results to address the CRL; resubmission will be classified Type 2 (up to six-month review), and topline HOPE-3 is imminent in Q4 2025 .
  • Key catalyst: HOPE-3 top-line readout and subsequent Type 2 BLA resubmission for DMD cardiomyopathy; potential $80M milestone from NS Pharma and a Priority Review Voucher if approval occurs before 9/30/2026 could materially extend runway .

What Went Well and What Went Wrong

What Went Well

  • “We are entering one of the most pivotal periods…we believe we are well positioned for potential approval and launch,” highlighting confidence in Deramiocel and commercial readiness (PLI accepted) .
  • FDA Type A meeting outcome supports submission of HOPE-3 data to address the CRL; resubmission designated Type 2, providing a clear review framework .
  • Mechanism-of-action publication and validated potency assay reinforce biological consistency across >100 lots, underpinning CMC quality for commercialization .

What Went Wrong

  • Revenue fell to $0 vs $2.26M in Q3 2024 due to full recognition of prior NS Pharma milestones by year-end 2024, increasing reliance on balance sheet and milestones until approval .
  • Operating expenses rose to $26.3M (vs $15.3M YoY) on HOPE-3 execution and commercial build-out; net loss widened to $24.6M (vs $12.6M YoY) .
  • Cash declined to $98.6M (from $151.5M at 12/31/24), and cash runway guidance reduced from “into 2027” earlier in the year to “into Q4 2026” post CRL .

Financial Results

Quarter-over-Quarter Trend (Q1 → Q2 → Q3 2025)

MetricQ1 2025Q2 2025Q3 2025
Revenue ($USD)$0 $0 $0
Total Operating Expenses ($USD)$24,982,948 $27,719,134 $26,284,040
Net Loss ($USD)$(24,391,594) $(25,910,791) $(24,570,647)
Diluted EPS ($USD)$(0.53) $(0.57) $(0.54)
Cash, Cash Equivalents & Marketable Securities ($USD)$144,777,396 $122,800,681 $98,565,971

Year-over-Year (Q3 2025 vs Q3 2024)

MetricQ3 2024Q3 2025
Revenue ($USD)$2,261,642 $0
Total Operating Expenses ($USD)$15,271,522 $26,284,040
Net Loss ($USD)$(12,556,728) $(24,570,647)
Diluted EPS ($USD)$(0.38) $(0.54)

Actual vs Wall Street Consensus (S&P Global)

MetricQ1 2025Q2 2025Q3 2025
Revenue Actual ($USD)$0 $0 $0
Revenue Consensus Mean ($USD)*$3,158,330*$778,000*$480,000*
EPS Actual ($USD)$(0.53) $(0.57) $(0.54)
EPS Consensus Mean ($USD)*$(0.32)*$(0.4689)*$(0.5475)*
# EPS Estimates*6*9*8*
# Revenue Estimates*6*10*10*

Values retrieved from S&P Global.*

KPIs and Operational Readiness

KPIQ3 2025 Status
HOPE-3 Phase 3 (n=105), endpoints: PUL v2.0 and LVEF by cMRI—topline imminent (Q4 2025)
FDA Type A meeting outcome: HOPE-3 data to address CRL; resubmission Type 2
San Diego GMP facility: PLI accepted; facility operational
Potency assay/mechanism publication in Biomedicines; >100 lots consistent
Cash runway guidance into Q4 2026
ATM usage: none as of 11/10/2025

Guidance Changes

MetricPeriodPrevious GuidanceCurrent GuidanceChange
Cash runwayCorporateInto 2027 (Q1 press release) Into Q4 2026 (Q2/Q3 updates) Lowered
Regulatory timelineHOPE-3 dataQ4 2025 expected (Q2) Q4 2025 “imminent” (Q3) Maintained/timing narrowed
BLA resubmission classificationFDA reviewType A mtg scheduled; resubmit plan (Q2) Type 2 resubmission (≤6-month review) (Q3) Specified/clarified
Manufacturing readinessCMC/PLI483s accepted; PLI findings addressed (Q2) PLI accepted; facility operational (Q3) Maintained
Revenue guidanceCorporateNone provided None provided Maintained

Earnings Call Themes & Trends

TopicPrevious Mentions (Q1 & Q2)Current Period (Q3)Trend
Regulatory path & CRLBLA under priority review; mid-cycle complete; AdCom planned (Q1) ; Type A scheduled post-CRL (Q2) FDA supports HOPE-3 data to address CRL; Type 2 resubmission; regulatory flexibility to consider totality of cardiac data From review-to-CRL to a defined remediation path
HOPE-3 endpoints/SAPProtocol amendment to consider LVEF; topline in Q4 (Q2) SAP explained; Cohort B focus; Hochberg approach; alpha usage and secondary endpoints clarified Greater statistical clarity; emphasis on commercial material
Manufacturing readiness483s accepted; PLI responses accepted (Q2) PLI accepted; San Diego facility fully operational for GMP production Execution readiness for launch strengthened
Safety profileProgram-wide strong safety through OLE (Q2) ~800 infusions to ~150 patients; no new safety signals Consistent safety reinforced
Exosome platform (StealthX)IND cleared; NIAID Phase 1 initiation planned (Q2) Phase 1 ongoing; initial data expected Q1 2026 (subject to NIAID) Program advancing; potential partnership interest later
Cash/burn & spend mixStrong cash ($145M) and runway (into 2027) (Q1) Expenses elevated due to HOPE-3/commercial build; burn monitored; runway into Q4 2026 Higher near-term spend; cautious pacing
Pricing policy/macroN/AMonitoring U.S./international pricing and MFN frameworks Early planning signals

Management Commentary

  • CEO: “We believe we are well positioned for potential approval and launch… With our commercial-ready manufacturing facility in place and our Pre-License Inspection completed…” .
  • CFO: “We ended the quarter with approximately $100 million in cash… eligible to receive $80 million milestone payment from NS Pharma and a priority review voucher if approved” .
  • CEO on regulatory flexibility: FDA will review “all of the data… make decisions based on… preponderance of all the data” for cardiomyopathy label .
  • CEO on SAP and Cohort B: Focus on Cohort B to demonstrate efficacy of commercial-scale product; Hochberg approach preserves alpha for secondaries .

Q&A Highlights

  • Topline disclosure: Initial report will include primary and key secondary endpoints; call to explain ramifications promptly after unblinding .
  • Statistical plan: Cohort B efficacy emphasis; Hochberg adjustment; alpha allocation clarified; potential for regulatory flexibility if PUL misses but cardiac LVEF strongly hits .
  • Safety/readout operations: Tri-level independent MRI reading with adjudication process; blinded to timepoint/patient/treatment .
  • Spend trajectory: HOPE-3 costs wind down while manufacturing and launch prep ramp; burn watched closely; NIAID funds StealthX Phase 1 .
  • Label strategy: Initial cardiomyopathy focus; skeletal muscle label expansion considered post initial approval discussions .

Estimates Context

  • Q3 2025: EPS beat by ~$0.01 (actual -$0.54 vs -$0.55 estimate); revenue missed ($0 vs $0.48M), reflecting cessation of NS Pharma revenue recognition post-2024 .*
  • Q2 and Q1 2025: EPS and revenue both missed consensus amid pre-approval status and ongoing trial/commercial readiness spend .*
  • Near-term estimate implications: Street may adjust revenue to zero until approval and rebase EPS for higher OpEx pre-launch; post-HOPE-3/Type 2 acceptance, models likely shift to milestone scenarios/pricing ramps .*

Values retrieved from S&P Global.*

Key Takeaways for Investors

  • Imminent HOPE-3 top-line is the near-term stock catalyst; strong cardiac LVEF data could be pivotal for cardiomyopathy label under FDA’s stated flexibility .
  • Type 2 resubmission provides a defined review window (up to six months); faster timelines are possible depending on data strength and FDA workload precedents .
  • Commercial readiness is advanced: PLI accepted, GMP systems operational, physician education and market access underway—reducing launch execution risk .
  • Balance sheet supports execution through Q4 2026; potential $80M NS Pharma milestone and PRV could extend runway substantially upon approval .
  • Q3 EPS modest beat vs consensus; revenue misses across quarters reflect end of contract recognition—do not signal demand issues; treat pre-revenue quarters as non-critical for top line .*
  • Watch Cohort B efficacy and MRI adjudication details; efficacy with commercial material is central to minimizing CMC-related review risk .
  • Secondary platform optionality (StealthX) has 1H 2026 data timing and potential partnership path; not core to DMD thesis but adds pipeline value .