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REVIVA PHARMACEUTICALS HOLDINGS, INC. (RVPH)·Q3 2025 Earnings Summary

Executive Summary

  • Q3 2025 delivered a narrower net loss of $4.01M and diluted EPS of $(0.06), materially better than prior year and quarter, aided by reduced operating expenses .
  • EPS beat consensus by ~$0.04 with $(0.06) actual vs $(0.097)* estimate; revenue remained pre-commercial with consensus $0* [S&P Global].
  • Regulatory momentum continued: pre-NDA meeting with FDA planned in Q4 2025 and NDA submission for schizophrenia targeted for Q2 2026; psoriasis IND timing shifted to H2 2026, from Q2 2026 previously .
  • Cash increased to $13.18M, supported by a $9.0M gross equity offering; IP strengthened with an EPO patent for brilaroxazine in pulmonary fibrosis .

What Went Well and What Went Wrong

What Went Well

  • EPS and net loss improved meaningfully YoY and sequentially as total operating expenses declined to $4.03M, supporting the EPS beat versus consensus .
  • Regulatory path clarified: “We are preparing for a pre-NDA meeting… and continue to target a potential NDA submission in the second quarter of 2026,” per CEO Laxminarayan Bhat, Ph.D. .
  • Portfolio strength: European patent (EP3749324) granted for brilaroxazine use in pulmonary fibrosis; OLE 1-year data reinforce sustained efficacy and favorable safety/adherence .

What Went Wrong

  • Psoriasis IND timeline pushed back to H2 2026 from Q2 2026, indicating a modest delay in dermatology expansion .
  • Continued operating losses with no product revenue; net loss of $4.01M underscores funding needs ahead of NDA and potential commercialization .
  • Potential need for a registrational RECOVER-2 trial remains under assessment pending FDA recommendation, sustaining regulatory timeline uncertainty .

Financial Results

P&L and Cash Comparison (oldest → newest)

MetricQ3 2024Q1 2025Q2 2025Q3 2025
Net Loss ($USD)$(8,365,798) $(6,432,840) $(6,053,610) $(4,010,773)
Diluted EPS ($)$(0.25) $(0.13) $(0.12) $(0.06)
Total Operating Expenses ($USD)$8,462,534 $6,538,167 $6,072,982 $4,029,841
Weighted Avg Shares (Basic/Diluted)33,804,693 48,644,339 49,847,872 72,685,740
Cash & Cash Equivalents ($USD)$5,558,817*$5,289,404 $10,363,714 $13,183,259

Notes: Values with asterisks retrieved from S&P Global.*

Q3 2025 Actual vs Estimates

MetricActualConsensusSurprise
Primary EPS ($)$(0.06)$(0.097)*+$0.037 (beat)
Revenue ($USD)N/A$0.00*N/A

Notes: Estimates retrieved from S&P Global.*

Segment Breakdown

  • Not applicable; RVPH is pre-commercial with no reported product revenue .

KPIs (Clinical Efficacy and Safety – OLE 1-year)

KPIResult
PANSS Total Score−18.1
PANSS Positive Symptoms−5.0
PANSS Negative Symptoms−4.4; Marder Negative Factor −4.4
General Psychopathology−8.7
Personal & Social Performance+11.3
CGI-S−0.8; ≥1-point improvement in 78%
Discontinuation Rate (1-year)35% (pooled doses)
Weight Gain~+1.5 kg; non–dose-dependent
Lipid ProfileFavorable improvement
Blood SugarComparable to baseline
Hormonal/ProlactinElevated prolactin reduced to normal/near-normal; improved thyroid/sexual function
Cardiac/GI/Liver SafetyNo clinically significant issues; no DILI

Guidance Changes

MetricPeriodPrevious GuidanceCurrent GuidanceChange
FDA Meeting (End-of-Phase vs Pre-NDA)Q4 2025End-of-Phase 3 meeting planned (Q2 release) Pre-NDA meeting planned Clarified stage
NDA Submission (Schizophrenia)2026Q4 2026 (Q1 release) Q2 2026 (maintained vs Q2) Raised (accelerated) vs Q1; Maintained vs Q2
Psoriasis IND (Liposomal-gel)2026Q2 2026 H2 2026 Lowered (pushed back)
RECOVER-2 (Potential registrational study)2025+Expected mid-2025 initiation (subject to financing) Assessing initiation pending FDA recommendation Deferred/contingent

Earnings Call Themes & Trends

Note: No Q3 2025 earnings call transcript was found in available filings; management held investor events during Oct–Nov 2025 .

TopicPrevious Mentions (Q1 & Q2)Current Period (Q3 2025)Trend
Regulatory Path (FDA)Q1: RECOVER-2 initiation expected mid-2025 ; Q2: End-of-Phase 3 meeting planned for Q4 2025 Pre-NDA meeting Q4 2025; NDA targeted Q2 2026 Progressing toward NDA; RECOVER-2 optional/assessed
R&D ExecutionOLE completed; robust efficacy/safety dataset (Q1/Q2) OLE full dataset highlighted; negative symptom and biomarker analyses presented Sustained efficacy and safety; data depth expanding
IP/PatentsLifecycle management and exclusivity efforts EPO patent for pulmonary fibrosis (EP3749324) IP strengthened across geographies
Financing/Capital$10M gross offering (Q2) $9M gross offering (Q3) Ongoing capital raises to fund pathway
PartnershipsPursuing opportunities (repeat) Continued pursuit Active BD focus

Management Commentary

  • “We are preparing for a pre-NDA meeting with the Food and Drug Administration (FDA) in the fourth quarter of the year and continue to target a potential NDA submission in the second quarter of 2026.” — Laxminarayan Bhat, Ph.D., Founder, President, and CEO .
  • “The consistent body of evidence for brilaroxazine… demonstrates broad-spectrum, durable efficacy, a favorable safety profile, and strong long-term adherence with once-daily dosing.” .
  • “Securing this latest patent further strengthens our intellectual property portfolio and underscores the broad therapeutic relevance of brilaroxazine’s unique mechanism of action…” .

Q&A Highlights

  • No formal Q3 earnings call transcript available; management engaged investors via conferences and a KOL webinar in October–November (Roth, Spartan Capital, AGP) .
  • Discussions across these events focused on schizophrenia clinical data, regulatory timelines, and market opportunity; negative symptom and biomarker data were showcased in scientific forums .

Estimates Context

  • Q3 2025 EPS: $(0.06) actual vs $(0.097)* consensus; ~+$0.037 surprise (beat).
  • Q3 2025 Revenue: Consensus $0.00*; actual pre-commercial.
  • Estimate depth: 7 EPS and 7 revenue estimates for the quarter.*

Notes: Values retrieved from S&P Global.*

Key Takeaways for Investors

  • EPS beat and sequential improvement in net loss reflect tighter operating spend; operating expenses fell to $4.03M, enhancing near-term earnings optics .
  • Regulatory path is a key catalyst: pre-NDA meeting in Q4 2025; NDA targeted for Q2 2026; monitor FDA feedback on need for RECOVER-2 .
  • IP moat expanding (EPO patent), supporting optionality beyond schizophrenia (e.g., IPF/PAH) .
  • Cash of $13.18M, boosted by a $9.0M equity raise; expect continued financing steps ahead of NDA and potential launch .
  • Clinical profile remains differentiated: sustained broad-spectrum efficacy, favorable safety including metabolic and hormonal markers, and adherence signal from OLE .
  • Dermatology expansion (psoriasis IND) is deferred to H2 2026; prioritize schizophrenia NDA execution before broader pipeline commitments .
  • Trading lens: near-term catalysts are regulatory meetings and ongoing data presentations; medium-term thesis hinges on NDA submission timing, financing cadence, and potential partnership milestones .