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VYNE Therapeutics Inc. (VYNE)·Q3 2025 Earnings Summary

Executive Summary

  • Q3 2025 delivered lower operating expenses and a narrower net loss: revenues of $0.169M, operating loss of $7.792M, and net loss of $7.280M ($-0.17 EPS), versus $0.121M, $13.091M, and $12.157M ($-0.29 EPS) in Q3 2024 .
  • Versus Q2 2025, R&D rose sequentially (to $5.256M from $4.881M) on a $1.0M VYN202 milestone to Tay, while total operating expenses modestly increased (to $7.961M from $7.611M); cash and securities ended at $32.7M vs. $39.6M in Q2 .
  • Management reiterated cash runway into the first half of 2027 (maintained from Q2 after raising from Q1’s 2H 2026), with cost reductions supporting the outlook .
  • Strategic review continues (options include partnerships/licensing/M&A); VYN202 toxicology dog study is ongoing to address partial hold in male subjects; repibresib Phase 2b was terminated with a partner sought for the program .

What Went Well and What Went Wrong

What Went Well

  • Cost discipline drove YoY operating expense reduction (-39.7%) and a narrower net loss (-40.1%); royalty revenues rose YoY (+39.7%) .
  • CEO emphasized progress on “value-creating opportunities” during strategic review: “we have made considerable progress… and look forward to providing an update” .
  • Early VYN202 signals: all treated subjects improved; biomarker reductions observed; female dosing was allowed at two doses post partial hold lift .

What Went Wrong

  • Repibresib Phase 2b failed to meet F‑VASI50/F‑VASI75 endpoints; trial terminated; high vehicle effect and elevated dropout rates cited .
  • VYN202 faces a partial FDA clinical hold in males pending a 12-week dog toxicology study (design agreed with FDA); adds uncertainty to clinical timelines .
  • Nasdaq minimum bid-price deficiency notice received (30 consecutive days below $1.00), introducing listing risk if compliance not regained by March 10, 2026 .

Financial Results

Quarterly performance (Q1 → Q3 2025)

MetricQ1 2025Q2 2025Q3 2025
Revenue ($USD Thousands)202 69 169
Total Operating Expenses ($USD Thousands)9,399 7,611 7,961
Operating Loss ($USD Thousands)(9,197) (7,542) (7,792)
Other Income, net ($USD Thousands)594 1,795 366
Net Loss ($USD Thousands)(8,611) (5,755) (7,280)
Diluted EPS ($USD)-0.20 -0.13 -0.17
Cash & Marketable Securities ($USD Thousands, period-end)50,300 39,600 32,700
Shares Outstanding (period-end)15,959,488 19,773,784 31,772,904

Q3 2025 vs. Q3 2024

MetricQ3 2024Q3 2025
Revenue ($USD Thousands)121 169
R&D ($USD Thousands)10,248 5,256
G&A ($USD Thousands)2,964 2,705
Operating Loss ($USD Thousands)(13,091) (7,792)
Net Loss ($USD Thousands)(12,157) (7,280)
Diluted EPS ($USD)-0.29 -0.17

R&D program spend (Q3 2025)

ProgramQ3 2025 R&D ($USD Thousands)
Repibresib (VYN201)2,100
VYN2022,414
Other R&D742

KPIs

KPIQ1 2025Q2 2025Q3 2025
Cash runway guidanceInto 2H 2026 Into 1H 2027 Into 1H 2027
Pre-funded warrants outstanding26,794,398 23,028,800 11,059,574
FDA status – VYN202Hold announced (Apr 25) Partial lift for females; dog tox study initiated Dog tox study ongoing; evaluating broader opportunities
Repibresib programPhase 2b topline expected mid‑year Topline miss; termination underway Seeking partner; program discontinued

Guidance Changes

MetricPeriodPrevious GuidanceCurrent GuidanceChange
Cash runwayQ1 → Q2 2025Into 2H 2026 Into 1H 2027 Raised
Cash runwayQ2 → Q3 2025Into 1H 2027 Into 1H 2027 Maintained

No formal revenue, margin, OpEx, OI&E, or tax rate guidance was provided in Q3 materials; focus remained on strategic alternatives and program milestones .

Earnings Call Themes & Trends

Note: No Q3 earnings call transcript was available after searches; themes below reflect press releases and 10‑Q commentary .

TopicPrevious Mentions (Q-2 and Q-1)Current Period (Q3 2025)Trend
Strategic review“Actively evaluating opportunities” (pre‑review) Formal review ongoing; options include partnerships/licensing/M&A/asset sales Escalating
VYN202 clinical pathFDA clinical hold (Apr); female dosing partially lifted; dog tox study planned 12‑week dog tox study ongoing; aim to lift male partial hold Progressing
Repibresib (VYN201) outcomesTopline expected mid‑2025 Topline miss; termination; seeking partner Concluding
Cash runwayInto 2H 2026 Raised/maintained into 1H 2027 Improving then stable
Listing statusNo prior mentionNasdaq minimum bid-price deficiency notice (Sept 11) New risk
Macro/tariffs & supply chainGeneral macro uncertainties notedExpanded tariff/trade risk factor; APIs sourced from China; potential cost/timeline impact Heightened disclosure
R&D executionQ1 higher spend; Q2 reductionQ3 R&D down YoY; VYN202 milestone to Tay ($1.0M) Focused spend

Management Commentary

  • “Consistent with our focus on growing shareholder value, we have made considerable progress in evaluating a number of potential value-creating opportunities as part of our strategic review process…” — David Domzalski, President & CEO (Q3 press release) .
  • “The strength of our recent clinical and preclinical findings for VYN202 provides a compelling scientific foundation as we determine the best path forward…” (Q2 press release) .
  • “We are disappointed with the results of our Phase 2b trial… impacted by an unexpectedly high treatment effect in the vehicle arm and a high discontinuation rate in the active arms… we intend to seek a development and commercialization partner for Repibresib.” (Vitiligo topline) .
  • “We intend to work closely with the FDA to address the clinical hold as expeditiously as possible…” (Apr 25 clinical hold announcement) .

Q&A Highlights

No Q3 2025 earnings call transcript or Q&A was identified after document and internet searches (none listed; none found within the period) [SearchDocuments; 2025-09–2025-12, earnings-call-transcript: none].

Estimates Context

Actuals versus S&P Global Wall Street consensus:

MetricQ1 2025Q2 2025Q3 2025
Revenue Actual ($USD Thousands)202 69 169
Revenue Consensus Mean ($USD)50*150*100*
EPS Actual ($USD)-0.20 -0.13 -0.17
Primary EPS Consensus Mean ($USD)-0.29*-0.223*-0.13*
Primary EPS – # of Estimates2*3*2*
Revenue – # of Estimates2*2*1*
  • Q3: Revenue beat (Actual $0.169M vs $0.100M consensus); EPS missed (Actual $-0.17 vs $-0.13 consensus). Q2: Revenue missed ($0.069M vs $0.150M); EPS in line/better than expected (Actual $-0.13 vs ~$-0.223). Q1: Revenue beat ($0.202M vs $0.050M); EPS missed ($-0.20 vs $-0.29 closer to street) .
  • Values marked with an asterisk are retrieved from S&P Global (Capital IQ) and may reflect limited analyst coverage; “# of Estimates” indicates small sample sizes, increasing potential variability.*

Key Takeaways for Investors

  • Strategic optionality is the near-term catalyst: outcomes could include partnering/licensing (especially repibresib), asset sales, or broader transactions; monitor updates from the ongoing review for stock-moving events .
  • Regulatory overhang remains: resolution of the VYN202 male partial hold hinges on dog toxicology data; positive readouts could de-risk the program and support re-initiation or pivot to new indications .
  • Cash runway into 1H 2027 provides time to execute strategic steps, but listing compliance (Nasdaq bid-price rule) is a separate tactical risk that could necessitate actions (e.g., reverse split) if the stock does not recover .
  • Repibresib’s Phase 2b miss reduces organic late-stage optionality; partnering success will determine residual value of the topical BET program .
  • Operating discipline is evident (YoY OpEx down ~40%), but minimal royalty revenue means P&L sensitivity is dominated by R&D pacing and milestone obligations (e.g., VYN202 payments to Tay) .
  • Macro/trade risks (APIs sourced from China) could elevate costs or timelines; factor potential tariff impacts and supply chain adjustments into scenario analysis .
  • Near-term trading setup: watch for strategic review announcements, VYN202 toxicology outcomes, and any listing compliance measures; these are the likely catalysts for re-rating.