Executive Summary

VYNE reported Q1 2025 royalty revenues of $0.20M, net loss of $8.61M, and loss per share of $0.20; cash, cash equivalents and marketable securities were $50.3M with runway into 2H 2026 .
Results beat S&P Global consensus: revenue $0.20M vs $0.05M* and EPS -$0.20 vs -$0.29*; R&D rose on VYN202 and repibresib program spend, while G&A decreased YoY .
Clinical hold placed on VYN202 Phase 1b psoriasis trial following non-clinical testicular toxicity in dogs; management is working with FDA to resolve; no serious adverse events in enrolled subjects to date .
Near-term catalyst: repibresib (VYN201) Phase 2b vitiligo top-line results expected mid-2025; resolution of VYN202 clinical hold could re-open psoriasis program timelines .

What Went Well and What Went Wrong

Repibresib Phase 2b vitiligo trial fully enrolled with top-line results expected mid-2025; CEO emphasized significant unmet need and repibresib’s potential differentiation: “we anticipate reporting top-line results... mid-year... vitiligo remains an area of significant unmet need, and we believe repibresib has the potential to become a highly differentiated and important therapy” .
Revenue and EPS both beat consensus; royalty revenue of $0.20M exceeded S&P Global estimate $0.05M*, and EPS loss of $0.20 beat the -$0.29* estimate .
Cash runway maintained into 2H 2026, reducing financing overhang in the near term .

FDA clinical hold on VYN202 Phase 1b psoriasis trial following dog toxicology finding; trial enrollment and dosing suspended, creating uncertainty around 2025 topline timing .
Net loss widened YoY to $8.61M vs $6.25M due to higher R&D; R&D expense increased to $6.12M from $3.71M YoY on VYN202 and repibresib trial costs .
Prior multi-program momentum now bifurcated: VYN201 advancing as planned, while VYN202 timeline is now contingent on resolving the hold .

P&L comparison vs prior year and prior quarter:

Metric	Q1 2024	Q4 2024	Q1 2025
Revenue ($USD Millions)	$0.10	$0.08	$0.20
R&D Expense ($USD Millions)	$3.71	$9.68	$6.12
G&A Expense ($USD Millions)	$3.77	$3.17	$3.28
Operating Loss ($USD Millions)	$(7.38)	$(12.77)	$(9.20)
Other Income, net ($USD Millions)	$1.14	$0.76	$0.59
Net Loss ($USD Millions)	$(6.25)	$(12.02)	$(8.61)
EPS ($USD)	$(0.15)	$(0.28)	$(0.20)

Consensus vs Actual (Q1 2025):

Note: Values with asterisks (*) retrieved from S&P Global.

Balance sheet and KPIs:

KPI	Q4 2024	Q1 2025
Cash, cash equivalents & marketable securities ($USD Millions)	$61.5	$50.3
Cash & cash equivalents ($USD Millions)	$19.93	$28.21
Marketable securities ($USD Millions)	$41.59	$22.06
Shares outstanding (Common)	14,830,013	15,959,488
Pre-funded warrants outstanding	27,842,740	26,794,398
Cash runway	2H 2026	2H 2026

Segment breakdown: Not applicable (royalty revenue only) .

KPIs: Royalty revenue from LEO Pharma agreement (Finacea foam) remains the sole revenue source .

Metric	Period	Previous Guidance	Current Guidance	Change
Repibresib (VYN201) Phase 2b vitiligo top-line timing	Mid-2025	Mid-2025	Mid-2025	Maintained
VYN202 Phase 1b psoriasis status/timing	Initiated; topline by YE 2025	Clinical hold; timing TBD	Lowered (program on hold)
Cash runway	Through 2H 2026	2H 2026	2H 2026	Maintained

(No Q1 2025 earnings call transcript available in the document set; themes compiled from press releases and 8-Ks.)

Topic	Q3 2024	Q4 2024	Q1 2025	Trend
R&D execution (VYN201 vitiligo)	Exceeded enrollment target; fully enrolled expected Dec 2024	Fully enrolled; top-line mid-2025 reiterated	Top-line mid-2025 reaffirmed	Stable execution, catalyst approaching
VYN202 development	Positive SAD/MAD progression; planned Phase 1b in 2025	Phase 1b initiated; topline by YE 2025	Clinical hold; enrollment/dosing suspended	Deteriorating (regulatory setback)
Cash runway & funding	Sufficient through end-2025	Runway into 2H 2026	Runway into 2H 2026	Improving then stable
Revenue model	Royalty-only	Royalty-only	Royalty-only	Unchanged

“During the first quarter of 2025, we continued to progress our Phase 2b trial evaluating repibresib for the treatment of vitiligo, and we anticipate reporting top-line results from this trial mid-year… we believe repibresib has the potential to become a highly differentiated and important therapy” — David Domzalski, President & CEO .
“We will continue to work closely with the FDA to address the clinical hold placed on our Phase 1b psoriasis trial… and we expect to provide additional updates as we gain concurrence on the necessary steps needed to move forward and lift the clinical hold” — David Domzalski .
“We intend to work closely with the FDA to address the clinical hold as expeditiously as possible… To date, there have been no serious adverse events observed in subjects that have been enrolled in the Phase 1b study” — David Domzalski .

No Q1 2025 earnings call transcript was available in the document set; therefore, Q&A highlights and tone changes cannot be assessed this quarter (searched earnings-call-transcript with no results) [ListDocuments Apr–Jun 2025].

Revenue beat: $0.20M actual vs $0.05M* consensus; EPS beat: -$0.20 actual vs -$0.29* consensus. Both had 2 contributing estimates* .
Post-quarter estimate adjustments likely modest on royalties; the bigger swing factor for forward estimates is timing of VYN201 Phase 2b readout and resolution of VYN202 clinical hold .

Note: Values with asterisks (*) retrieved from S&P Global.

Near-term binary catalyst: repibresib Phase 2b vitiligo top-line mid-2025; outcome will shape medium-term value creation and partnering optionality .
Regulatory overhang: VYN202 clinical hold introduces timeline risk for psoriasis and potentially broader BD2 program; watch for FDA dialogue updates .
Operating discipline: runway into 2H 2026 reduces immediate financing risk; leverage point is de-risking assets to improve cost of capital .
P&L trajectory: royalty-only revenue base; losses driven by R&D; expect continued volatility tied to clinical milestones rather than fundamentals .
Trading setup: potential for event-driven volatility around vitiligo readout; absence of call transcript limits tone insights but press release signals confidence in VYN201 and urgency on VYN202 .
Monitor catalysts: FDA hold resolution, VYN201 top-line, and any strategic updates (e.g., partnerships) post-readout .
Risk management: position sizing should reflect binary clinical outcomes and regulatory uncertainty, with cash runway mitigating near-term dilution risk .