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VYNE Therapeutics Inc. (VYNE)·Q4 2024 Earnings Summary

Executive Summary

  • Q4 2024 delivered minimal revenue ($0.084M) and a wider net loss ($12.022M; EPS $(0.28)), reflecting accelerated clinical spend; full-year cash was $61.5M with runway now guided into 2H 2026 .
  • Pipeline execution advanced: repibresib gel (VYN201) Phase 2b in vitiligo completed enrollment in January 2025 with topline expected mid-2025, and VYN202 Phase 1b in psoriasis initiated with topline by year-end 2025 .
  • Positive Phase 1a MAD results for VYN202 (Dec 23, 2024) demonstrated favorable safety/tolerability, robust PK/PD, and no class-limiting AEs seen in earlier BET inhibitors—supporting advancement into patient trials .
  • Wall Street consensus estimates via S&P Global were unavailable; comparisons to estimates cannot be made (S&P Global access error).
  • Near-term stock catalysts: mid-2025 VYN201 Phase 2b topline and year-end 2025 VYN202 Phase 1b topline; cash runway extension reduces financing overhang into these readouts .

What Went Well and What Went Wrong

What Went Well

  • Clinical milestones achieved: “Based on our significant progress in 2024, we are now positioned to announce two key data readouts… We are off to a strong start in 2025,” (CEO) with VYN201 Phase 2b enrollment completed and VYN202 Phase 1b initiated .
  • VYN202 Phase 1a MAD data were positive, showing dose-dependent exposure, target engagement (HEXIM-1), significant inhibition of inflammatory biomarkers, and no class-limiting toxicities (e.g., thrombocytopenia), de-risking the BD2-selective approach .
  • Liquidity guidance improved: cash, cash equivalents, and marketable securities of $61.5M at year-end and runway guided into 2H 2026, stretching beyond key 2025 data events .

What Went Wrong

  • Operating losses widened with R&D step-up (Q4 operating loss $(12.770)M vs $(6.832)M prior year; net loss $(12.022)M vs $(6.188)M), reflecting Phase 2b and Phase 1 costs .
  • Revenue remains de minimis and non-core (royalty only: $0.084M in Q4), providing limited offset to increased OpEx and no commercial margin contribution .
  • Potential dilution overhang persists given the capital-intensive pipeline and outstanding pre-funded warrants to purchase 27,842,740 shares (exercise price $0.0001), alongside modest cash burn protection from other income .

Financial Results

Quarterly Performance (Q2 → Q3 → Q4 2024)

MetricQ2 2024Q3 2024Q4 2024
Revenue (Total) ($USD Millions)$0.198 $0.121 $0.084
R&D Expense ($USD Millions)$7.306 $10.248 $9.684
G&A Expense ($USD Millions)$3.288 $2.964 $3.170
Total Operating Expenses ($USD Millions)$10.594 $13.212 $12.854
Operating Loss ($USD Millions)$(10.396) $(13.091) $(12.770)
Other Income, net ($USD Millions)$1.001 $0.934 $0.760
Net Loss ($USD Millions)$(9.406) $(12.157) $(12.022)
Diluted EPS ($USD)$(0.22) $(0.29) $(0.28)

Year-over-Year (Q4 2024 vs Q4 2023)

MetricQ4 2023Q4 2024
Revenue (Total) ($USD Millions)$0.076 $0.084
R&D Expense ($USD Millions)$3.023 $9.684
G&A Expense ($USD Millions)$3.885 $3.170
Operating Loss ($USD Millions)$(6.832) $(12.770)
Other Income, net ($USD Millions)$0.680 $0.760
Net Loss ($USD Millions)$(6.188) $(12.022)
Diluted EPS ($USD)$(0.20) $(0.28)

Segment/Revenue Breakdown

SegmentQ2 2024Q3 2024Q4 2024
Royalty revenue (Finacea® foam) ($USD Millions)$0.198 $0.121 $0.084

KPIs and Liquidity

KPIQ2 2024Q3 2024Q4 2024
Cash, cash equivalents, marketable securities ($USD Millions)$78.1 (includes restricted cash) $70.2 (includes restricted cash) $61.5
Cash runway guidanceThrough end of 2025 Through end of 2025 Into 2H 2026
Common shares outstanding (period-end)14,536,124 14,751,433 14,830,013
Pre-funded warrants outstandingN/A disclosed 27,842,740 27,842,740

Guidance Changes

MetricPeriodPrevious GuidanceCurrent GuidanceChange
Cash runwayCorporateThrough end of 2025 Into 2H 2026 Raised
VYN201 Phase 2b topline (vitiligo)Mid-2025Mid-2025 Mid-2025 Maintained
VYN201 Phase 2b enrollment statusQ4/Q1Expected to complete Dec 2024 Completed enrollment in Jan 2025 Achieved
VYN202 Phase 1a MAD resultsQ4 2024Expected Q4 2024 Reported positive MAD results Dec 23, 2024 Achieved
VYN202 Phase 1b psoriasis topline20252H 2025 anticipated By year-end 2025; trial initiated Feb 2025 Clarified/maintained timeline
Revenue/margins/OpEx guidanceQ4 2024Not providedNot providedN/A

Earnings Call Themes & Trends

TopicPrevious Mentions (Q2 2024)Previous Mentions (Q3 2024)Current Period (Q4 2024)Trend
R&D execution (VYN201)Phase 2b vitiligo initiated; 3-dose cohorts; 24-week DB + extension Exceeded enrollment target; expected full enrollment Dec 2024 Enrollment completed Jan 2025; topline mid-2025 Improving execution
R&D execution (VYN202)Phase 1a SAD/MAD initiated in June 2024 Positive SAD; MAD data expected Q4 2024 Positive MAD results reported; Phase 1b psoriasis initiated; topline by YE 2025 Progressing on plan
Cash runwayFund key milestones through end of 2025 Through end of 2025 Into 2H 2026 Strengthened
Revenue baseRoyalty revenue $0.198M $0.121M $0.084M Modestly declining q/q
Conferences/IRSep investor conferences —Leerink Partners/H.C. Wainwright conferences Mar 2025 Ongoing investor engagement

Management Commentary

  • “Based on our significant progress in 2024, we are now positioned to announce two key data readouts for repibresib gel and VYN202 in 2025… we announced the completion of enrollment in the Phase 2b trial… and we expect to report topline results in mid-2025. We also recently initiated the Phase 1b trial of our oral BD2-selective BET inhibitor, VYN202… with topline results by the end of this year.” — David Domzalski, President & CEO .
  • On VYN202 Phase 1a MAD: “We are very excited by the PK, pharmacodynamic and safety data… which not only support the further development of VYN202 but also give us increased confidence that VYN202 has the potential to become a novel treatment option for immune-mediated diseases.” — David Domzalski .

Q&A Highlights

  • No Q4 2024 earnings call transcript was available in our document set; therefore, Q&A highlights and any call-based guidance clarifications are unavailable [SearchDocuments result: none].

Estimates Context

  • Wall Street consensus estimates (EPS, revenue) for Q4 2024 via S&P Global were unavailable due to data access limits; as a result, this report does not include estimate comparisons or beat/miss analysis for VYNE’s quarter (S&P Global request error).

Key Takeaways for Investors

  • Clinical execution continues to be the core value driver: VYN201 (vitiligo) topology mid-2025 and VYN202 (psoriasis) Phase 1b topline by year-end 2025 are the primary catalysts .
  • The positive VYN202 MAD dataset and absence of class-limiting toxicities de-risk BD2-selective BET approach, supporting broader immunology potential and optionality in future indications or combinations .
  • Liquidity runway extended into 2H 2026, reducing near-term financing risk and aligning cash with key 2025 readouts; monitor burn trajectory and any partnering optionality .
  • Quarterly financials reflect deliberate R&D scaling (Q4 R&D $9.684M vs $3.023M YoY); the “why” is clear—Phase 2b and Phase 1 study costs for lead assets .
  • With non-core royalty revenue only, fundamentals hinge on clinical outcomes; stock likely sensitive to trial milestones and any regulatory feedback disclosed.
  • Keep watch for additional patient data clarity (psoriasis Phase 1b endpoints, biomarker correlations) and potential early signs of efficacy translating from PK/PD signals .
  • Dilution risk persists given warrants and development needs, but extended runway mitigates immediate pressure as management advances programs toward value-inflecting data .