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VYNE Therapeutics Inc. (VYNE): Business Model Canvas [Dec-2025 Updated] |
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VYNE Therapeutics Inc. (VYNE) Bundle
You're trying to make sense of VYNE Therapeutics Inc. right now, and honestly, the financial reality is stark: with only $32.7 million in the bank as of September 30, 2025, the company is burning cash fast, having spent $16.3 million on R&D in just nine months, while only pulling in $0.44 million from Finacea® royalties. This Business Model Canvas cuts through the biotech jargon to show you exactly how the VYN201 progress and the VYN202 hold impact their Key Activities, what their actual Revenue Streams look like today, and where their $8.7 million G&A spend is going. It's a precise map of their current operating reality, showing you the core assets and the immediate strategic pressures they face-read on to see the full nine blocks.
VYNE Therapeutics Inc. (VYNE) - Canvas Business Model: Key Partnerships
You're looking at the core external relationships that fuel VYNE Therapeutics Inc.'s operations as of late 2025. These aren't just names on a slide; they represent direct financial flows and critical development milestones.
LEO Pharma A/S for royalty revenue from Finacea® foam
This partnership provides VYNE Therapeutics Inc. with its current revenue base, stemming from the Finacea® foam license. You see this trickle in quarterly.
For the three months ended September 30, 2025, royalty revenues totaled $0.2 million. This compares to $0.1 million for the same period in 2024. For the first six months of 2025, the cumulative royalty revenue from LEO Pharma A/S was $0.3 million.
Here's a quick look at the recent royalty income:
| Period Ended | Royalty Revenue (Millions USD) |
|---|---|
| March 31, 2025 (Q1) | 0.2 |
| June 30, 2025 (Q2) | 0.1 |
| September 30, 2025 (Q3) | 0.2 |
Tay Therapeutics Ltd for the VYN202 license agreement
The relationship with Tay Therapeutics Ltd. involves significant potential future payments tied to the VYN202 program. In the third quarter of 2025, VYNE Therapeutics Inc. made a $1.0 million milestone payment to Tay under an amendment to the VYN202 License Agreement. This payment resolved a dispute regarding the Phase 2 milestone. The amendment stipulates that VYNE Therapeutics Inc. will pay an additional $4,000,000 if a qualifying Phase 2 clinical trial for VYN202 is initiated.
The original terms for VYN202 included potential milestone revenues of over $65 million for the first indications, plus tiered royalty payments of up to 10% of net annual sales upon market approval. Earlier in the program's history, VYNE Therapeutics Inc. made a one-time cash payment of $3.75 million to Tay in April 2023 to enter the VYN202 License Agreement.
Clinical research organizations (CROs) managing Phase 2b trials
The Phase 2b trial for repibresib gel in nonsegmental vitiligo, which involved approximately 180 subjects, was terminated in July 2025 after topline results. The trial design utilized three dose cohorts: 1%, 2%, and 3% concentrations, compared to vehicle. The costs associated with this trial directly impacted R&D expenses; for instance, R&D expenses decreased by $3.9 million in Q3 2025, primarily due to the timing of expenses related to the Phase 2b trial termination.
The VYN202 Phase 1b trial in moderate-to-severe plaque psoriasis had preliminary data from seven subjects enrolled before a partial clinical hold was in place.
Academic and clinical investigators for trial execution
The execution of the repibresib Phase 2b trial (NCT06493578) relied on investigators managing the study protocol. The randomization ratio was 1:1:1:1 across the active drug cohorts and vehicle. This meant approximately 45 subjects were allocated to each of the four arms for the initial 24-week efficacy evaluation period. The VYN202 Phase 1b trial involved subjects with moderate-to-severe plaque psoriasis.
The financial impact on R&D spending in Q1 2025 included an increase of $0.7 million for repibresib trial costs.
VYNE Therapeutics Inc. (VYNE) - Canvas Business Model: Key Activities
You're looking at the core engine of VYNE Therapeutics Inc. right now, which is heavily weighted toward clinical execution and strategic positioning as of late 2025. The key activities are about advancing the pipeline while managing the capital structure.
Conducting clinical trials for repibresib gel (VYN201) in vitiligo
This activity has recently concluded a major phase. VYNE Therapeutics Inc. announced the topline results from the Phase 2b trial of repibresib gel (VYN201) in nonsegmental vitiligo in July 2025. The trial was a randomized, double-blind, vehicle-controlled study evaluating once-daily repibresib gel in three dose cohorts, specifically 1%, 2%, or 3% concentrations, compared to vehicle over 24 weeks. The trial randomized subjects equally across the active drug cohorts or vehicle, with approximately 45 subjects per cohort. Following the results announcement, the Company made the decision to terminate the trial. This termination directly impacted R&D spending, leading to a decrease in expenses for repibresib of $3.9 million for the three months ended September 30, 2025, compared to the same period in 2024.
Managing the FDA clinical hold on the VYN202 program
A critical activity involves remediation efforts for VYN202, the oral BD2-selective BET inhibitor. The U.S. Food and Drug Administration (FDA) placed a clinical hold on the Phase 1b trial in moderate-to-severe plaque psoriasis in April 2025 following testicular toxicity observations in dogs. The management activity here involved securing a partial lift of the hold in June 2025, allowing studies in two doses for female subjects. To resume studies in male clinical subjects, VYNE Therapeutics Inc. initiated a repeat 12-week, non-clinical toxicology study in dogs. The VYN202 program had seven subjects enrolled in the Phase 1b trial before the hold. The expense associated with VYN202 decreased by $1.0 million for the three months ended September 30, 2025, year-over-year, though this was partially offset by a $1.0 million milestone payment made to Tay in the third quarter of 2025 under the license agreement amendment.
Executing a strategic review to maximize stockholder value
The Board of Directors initiated a strategic review in August 2025 to evaluate options for maximizing stockholder value. This review includes assessing internal pipeline opportunities, financing options, and broader strategic alternatives such as strategic partnerships, licensing, merger or acquisition transactions, or asset sales. The Company engaged LifeSci Capital to assist in this process.
Research and development of the proprietary InhiBET™ BET Inhibitor Platform
Overall R&D spending reflects the prioritization of pipeline assets. VYNE Therapeutics Inc.'s research and development expenses for the three months ended September 30, 2025, totaled $5.3 million. This figure represents a decrease of $5.0 million, or 48.7%, compared to $10.2 million for the same period in 2024. The InhiBET™ platform is the foundation for VYN202, designed to overcome limitations of earlier BET inhibitors through alternative administration routes and enhanced selectivity.
Securing and maintaining intellectual property for drug candidates
Maintaining the IP estate involves regular corporate filings. VYNE Therapeutics Inc. filed several documents with the U.S. Securities and Exchange Commission in late 2025, including filings on November 14, 2025, and a SCHEDULE 13G/A on August 14, 2025.
Here's a quick look at the financial context supporting these activities as of the end of Q3 2025:
| Financial/Statistical Metric | Value as of September 30, 2025 |
| Cash, Cash Equivalents, and Marketable Securities | $32.7 million |
| Projected Cash Runway | Into the first half of 2027 |
| Total Revenues (Q3 2025) | $0.2 million |
| Net Loss (Q3 2025) | $7.28 million |
| Common Shares Issued and Outstanding | 31,772,904 |
The company's general and administrative expenses for the three months ended September 30, 2025, were $2.7 million.
Finance: draft 13-week cash view by Friday.
VYNE Therapeutics Inc. (VYNE) - Canvas Business Model: Key Resources
You're looking at the core assets VYNE Therapeutics Inc. has on the books right now to drive its strategy forward. These aren't just line items; they are the foundation of their potential value creation, especially as they navigate the strategic review initiated in August 2025.
The financial foundation is definitely a key resource. As of September 30, 2025, VYNE Therapeutics Inc. held $32.7 million of cash, cash equivalents and marketable securities. This capital position, following cost reductions, is projected to fund operations into the first half of 2027.
The scientific and intellectual property assets are centered around their proprietary small molecule BET inhibitor technology. Here's a quick look at the pipeline assets that represent the core of their R&D value:
| Asset | Type/Mechanism | Development Status (as of late 2025) | Key IP Exclusivity |
|---|---|---|---|
| VYN201 (Repibresib gel) | Locally-administered pan-BD BET inhibitor | Phase 2b trial in nonsegmental vitiligo discontinued extension phase following July 2025 topline results; seeking a development and commercialization partner. | Composition of matter exclusivity into at least 2042 in the United States. |
| VYN202 | Oral BD2-selective BET inhibitor | Phase 1b psoriasis trial has a partial clinical hold; repeat 12-week toxicology study in dogs ongoing to potentially remove the hold for male subjects. | Part of the InhiBET™ platform IP. |
| InhiBET™ Platform | Proprietary BET inhibitor technology | Core technology designed to overcome limitations of early generation BET inhibitors via alternative routes and enhanced selectivity. | Protected by the portfolio covering the compounds. |
The scientific expertise is inherent in the team's ability to manage these complex programs. The company is clinical-stage, focused on developing differentiated therapies for inflammatory and immune-mediated conditions with high unmet need. To be fair, the recent termination of the VYN201 trial extension phase and the ongoing VYN202 hold present near-term challenges to fully realizing this expertise.
Beyond the pipeline, the tangible operational resources support the current structure:
- Cash, cash equivalents, and marketable securities as of September 30, 2025: $32.7 million.
- Common shares issued and outstanding as of September 30, 2025: 31,772,904.
- Outstanding pre-funded warrants to purchase common stock: 11,059,574 shares.
- Full-time employees: 28.
- Net loss for the three months ended September 30, 2025: $7.3 million.
- Research and development expenses for the three months ended September 30, 2025: $5.3 million.
- General and administrative expenses for the three months ended September 30, 2025: $2.7 million.
- Royalty revenue for the three months ended September 30, 2025: $0.2 million.
Finance: review the cash burn rate against the H1 2027 runway projection by next Tuesday.
VYNE Therapeutics Inc. (VYNE) - Canvas Business Model: Value Propositions
VYNE Therapeutics Inc. offers differentiated therapeutic candidates designed to address significant unmet medical needs in chronic inflammatory and immune-mediated conditions.
VYN201 (Repibresib): Locally-administered pan-BET inhibitor for nonsegmental vitiligo
The value proposition for VYN201 centers on providing a novel, locally-administered small molecule pan-BD BET inhibitor for nonsegmental vitiligo. Although topline results from the Phase 2b trial were reported in July 2025, and the trial was subsequently terminated, the data indicated potential in specific measures.
The Phase 2b trial, which finalized enrollment in January 2025, evaluated once-daily repibresib gel in three dose cohorts (1%, 2% or 3% concentrations) over 24 weeks. The trial did not meet the primary or secondary endpoint of F-VASI50 and F-VASI75. However, statistically significant effects were observed in key secondary and exploratory endpoints, specifically change from baseline in F-VASI and T-VASI, and the proportion of patients achieving T-VASI50 at the 3% concentration. VYNE Therapeutics is now seeking a development partner for this program.
The potential value is situated within a market where nonsegmental vitiligo is a major component:
| Metric | Value/Data Point | Context/Date |
| Global Vitiligo Treatment Market Size | USD 1.60 billion | 2025 |
| Non-segmental Vitiligo Market Share | 65.51% | 2024 |
| Topical Treatment Market Share (Largest Segment) | 32.75% | 2024 |
Potential for a differentiated, non-systemic topical treatment option
VYN201's value proposition is rooted in its topical administration route, which inherently suggests a differentiated profile by minimizing systemic exposure compared to systemic therapies. This local delivery mechanism is intended to target inflammatory pathways directly at the site of disease activity.
The company's financial focus in late 2025 reflects a shift in resource allocation, which supports the evaluation of pipeline assets for strategic alternatives, including partnerships for VYN201. Research and development expenses for the three months ended September 30, 2025, were $5.3 million, representing a decrease of 48.7% year-over-year, partly due to decreased expenses for repibresib.
VYN202: Oral BD2-selective inhibitor for serious, immune-mediated diseases
VYN202, an oral small molecule BD2-selective BET inhibitor, presents a value proposition as a potential disease-modifying therapy for a broad range of immune-mediated disorders. The company is progressing with non-clinical studies to address a partial clinical hold for male subjects, which was initially placed following observations of testicular toxicity in dogs.
The FDA partially lifted the hold in June 2025, allowing female subjects to be dosed at 0.25 mg and 0.5 mg in the Phase 1b psoriasis trial. Preliminary efficacy signals from this small trial (n=7) showed promising results in moderate-to-severe plaque psoriasis:
- PASI score improvements ranged from 27% reduction after 1 week to 90% reduction at week 8.
- Significant reductions in inflammatory biomarkers, including IL17A, IL17F, IL19, and IL22, were observed.
The company made a $1.0 million milestone payment to Tay in the third quarter of 2025 under the VYN202 License Agreement.
Addressing high unmet medical need in chronic inflammatory conditions
The overarching value proposition for VYNE Therapeutics Inc. is the development of therapies for conditions where current options are insufficient. The company's cash position as of September 30, 2025, was $32.7 million, which, based on current operating assumptions, is believed to fund operations into the first half of 2027.
Financial discipline is evident, with the net loss for the third quarter of 2025 narrowing to $7.3 million from $12.2 million in the comparable period of 2024. This focus on cost management supports the continued, albeit modified, advancement of pipeline candidates like VYN202, which is being evaluated for serious, immune-mediated diseases. The company is actively engaged in a strategic review to maximize shareholder value, which includes assessing financing opportunities and strategic alternatives.
Key financial metrics as of September 30, 2025:
- Cash, cash equivalents and marketable securities: $32.7 million.
- Projected cash runway: Into the first half of 2027.
- Q3 2025 Net Loss: $7.3 million.
- Q3 2025 R&D Expenses: $5.3 million.
VYNE Therapeutics Inc. (VYNE) - Canvas Business Model: Customer Relationships
You're looking at how VYNE Therapeutics Inc. manages its critical external relationships, which, for a clinical-stage company, are heavily weighted toward regulators and scientific experts. It's a high-stakes dialogue, especially given the recent clinical setbacks and strategic pivots.
High-touch, regulatory-focused interaction with the FDA
Interaction with the U.S. Food and Drug Administration (FDA) is intense and centered on clinical data integrity and safety signals. You saw this play out clearly in 2025. The FDA verbally placed a clinical hold on the VYN202 Phase 1b study for moderate-to-severe plaque psoriasis in April 2025, stemming from testicular toxicity observed in non-clinical dog studies.
The relationship is now focused on remediation. As of November 2025, VYNE Therapeutics Inc. is progressing a repeat 12-week, non-clinical toxicology study in dogs for VYN202, which they believe will allow them to remove the partial hold for testing VYN202 in male clinical subjects. To be fair, they did secure a partial win: in June 2025, the FDA lifted the clinical hold for two doses of VYN202 specifically for female subjects.
Here are the key regulatory timeline points:
- FDA verbally placed VYN202 Phase 1b clinical hold: April 2025.
- FDA lifted partial hold for female subjects on VYN202: June 2025.
- Top-line results for Repibresib gel Phase 2b trial announced: July 2025.
- The Repibresib Phase 2b trial was subsequently terminated.
Direct engagement with clinical investigators and key opinion leaders (KOLs)
Engaging clinical investigators is paramount for running trials, though the focus shifted after the Repibresib Phase 2b trial concluded. That trial, NCT06493578, was a randomized, double-blind, vehicle-controlled study for nonsegmental vitiligo.
The structure of that engagement involved specific patient randomization numbers. Subjects were randomized equally (1:1:1:1 ratio) across the active drug cohorts or vehicle. The trial included three dose cohorts (1%, 2%, or 3% concentrations) plus vehicle, with approximately 45 subjects in each arm. While the trial didn't hit the primary endpoint (F-VASI50 and F-VASI75), statistically significant effects were noted in secondary endpoints for the 3% concentration.
We can map out the trial structure that required investigator management:
| Trial Component | Metric/Value |
| Product Candidate | Repibresib gel (VYN201) |
| Indication | Nonsegmental Vitiligo |
| Total Arms (Dose + Vehicle) | 4 |
| Active Dose Concentrations | 3 (1%, 2%, 3%) |
| Approximate Subjects Per Arm | 45 |
Investor relations via press releases and quarterly earnings calls
Investor communication is managed through regular press releases and participation in investor conferences. You should definitely monitor the cadence of these updates. The company released Q1, Q2, and Q3 2025 financial results on May 8, 2025, August 14, 2025, and November 6, 2025, respectively.
The financial health dictates the relationship's tone. As of September 30, 2025, the cash position was $32.7 million, which they project will fund operations into the first half of 2027. The net loss for Q3 2025 narrowed to $7.3 million, or a basic/diluted loss per share of $0.17, down from a loss of $12.2 million ($0.29 per share) in Q3 2024. The common shares outstanding as of that date were 31,772,904.
Here's a snapshot of the latest reported financials:
| Metric (As of 9/30/2025) | Amount/Value |
| Cash, Cash Equivalents, Marketable Securities | $32.7 million |
| Projected Cash Runway | Into 1H 2027 |
| Q3 2025 Net Loss | $7.3 million |
| Q3 2025 Basic Loss Per Share | $0.17 |
| Common Shares Outstanding | 31,772,904 |
| Stock Price (Dec 2, 2025) | $0.36 |
Strategic outreach to potential pharmaceutical partners for licensing
Strategic outreach is currently formalized under a broader corporate action. In August 2025, the Board initiated a strategic review to evaluate options to maximize stockholder value, which explicitly includes assessing strategic partnerships and licensing opportunities. This is the primary current mechanism for external commercial/development relationship building.
While waiting on the outcome of that review, the company still generates minimal revenue from past deals. For the quarter ended March 31, 2025, VYNE Therapeutics Inc. reported royalty revenue of $0.2 million from its agreement with LEO Pharma A/S concerning Finacea® foam. This shows an existing, albeit small, revenue stream derived from a prior licensing relationship.
Key data points regarding partnership/licensing focus:
- Strategic Review initiated to explore partnerships/licensing: August 2025.
- Royalty Revenue (Q1 2025): $0.2 million.
- Previous major licensing event (In4Derm BET platform): August 2021.
Finance: draft 13-week cash view by Friday.
VYNE Therapeutics Inc. (VYNE) - Canvas Business Model: Channels
You're looking at how VYNE Therapeutics Inc. gets its products, data, and corporate messages to the right people. For a clinical-stage company, the channels are heavily weighted toward clinical execution and regulatory interaction, plus the necessary investor outreach.
Clinical trial sites and contract research organizations (CROs)
The execution of clinical studies is a primary channel for data generation and regulatory interaction. For the Repibresib gel Phase 2b trial in nonsegmental vitiligo, the company utilized 45 sites in North America to enroll subjects. This trial involved a randomized, double-blind, vehicle-controlled design with subjects equally randomized (1:1:1:1 ratio) across three active dose cohorts (1%, 2%, or 3% concentrations) and the vehicle group, with approximately 45 subjects in each arm.
For the VYN202 program, the Phase 1b trial in moderate-to-severe plaque psoriasis faced a clinical hold in April 2025. However, by June 2025, the FDA lifted this hold for two doses of VYN202 for female subjects. The company is currently running a 12-week, non-clinical toxicology study in dogs to address the partial hold for male clinical subjects. Research and development expenses related to these activities for the three months ended September 30, 2025, were $5.3 million, a 48.7% decrease from the prior year's $10.2 million.
Key operational metrics related to clinical channels include:
- Phase 2b Repibresib trial sites: 45
- VYN202 clinical hold lifted for: two doses
- VYN202 toxicology study duration: 12-week
- R&D expense for Q3 2025: $5.3 million
Regulatory submissions and direct communication with the FDA
Direct engagement with the U.S. Food and Drug Administration (FDA) is critical for advancing pipeline assets. The most significant recent regulatory channel events involved the VYN202 program and the Repibresib trial results.
The FDA verbally placed a clinical hold on the VYN202 Phase 1b trial in April 2025. The company announced topline results from the Repibresib Phase 2b trial on July 30, 2025. Following these results, VYNE Therapeutics Inc. stated its intent to seek an outside partner for Repibresib's continued development.
The table below summarizes key regulatory timeline touchpoints in 2025:
| Product/Trial | Regulatory Event/Communication | Date | Status/Action |
| VYN202 Phase 1b | Verbal Clinical Hold Issued by FDA | April 2025 | Suspended screening, enrollment, and dosing |
| VYN202 Phase 1b | FDA Lifted Hold for Female Subjects | June 2025 | Allowed continuation for female subjects on two doses |
| Repibresib Phase 2b | Announcement of Topline Results | July 30, 2025 | Company to seek external partner for continued development |
Investor conferences and corporate website for public disclosure
VYNE Therapeutics Inc. uses investor conferences and its corporate website as primary channels for communicating with the investment community, often to comply with Regulation FD disclosure rules. Management participated in two key conferences in March 2025.
The company's investor relations strategy included:
- Participation in the TD Cowen 45th Annual Health Care Conference on March 4, 2025, which included a fireside chat and one-on-one meetings.
- Participation in the Leerink Partners Global Healthcare Conference on March 11, 2025, featuring one-on-one meetings.
- Webcast replays for the Leerink conference were made available on the VYNE website for 90 days.
Financially, the company reported its Q3 2025 results on November 6, 2025. As of September 30, 2025, the company had $32.7 million in cash, cash equivalents, and marketable securities, projecting a cash runway into the first half of 2027. The Annual Meeting for stockholders of record as of November 6, 2025, is scheduled for December 12, 2025.
Future pharmaceutical licensing and commercialization partners
The company is actively using its strategic review, initiated in August 2025, to explore channels for external partnerships, including licensing opportunities. This is a direct channel to monetize pipeline assets that the company may not commercialize internally.
Current partnership-related financial data points include:
- Royalty revenue from the existing license with LEO Pharma A/S (for Finacea foam) for Q3 2025: $0.2 million.
- A $1.0 million milestone payment was made to Tay in Q3 2025 under the VYN202 License Agreement amendment.
The strategic review initiated in August 2025 explicitly evaluates alternatives such as strategic partnerships and licensing opportunities. Finance: draft 13-week cash view by Friday.
VYNE Therapeutics Inc. (VYNE) - Canvas Business Model: Customer Segments
You're looking at the customer segments for VYNE Therapeutics Inc. (VYNE) as of late 2025. This is a clinical-stage biotech, so the customer base is split between the people who need the medicine and the people who fund the science.
Patients with nonsegmental vitiligo and other chronic inflammatory diseases.
The primary patient segment is individuals suffering from nonsegmental vitiligo, an autoimmune depigmenting disorder where treatment options are severely limited; only 1 FDA-approved therapy exists as of early 2025. VYNE Therapeutics Inc. is focused on this high unmet need area with its lead candidate, repibresib gel (VYN201). The patient pool is substantial, with an estimated 70 million people globally affected by vitiligo, which is approximately 1% of the global population. Specifically within the 7MM (Major Markets), the 12-month prevalence of vitiligo was estimated at 8.2 million cases in 2023, with about 500K cases being treated. The US represents a significant portion, accounting for roughly 60% of those diagnosed cases in the 7MM. The Phase 2b trial for VYN201 involved approximately 180 participants across 45 sites in North America. Beyond vitiligo, VYNE Therapeutics Inc. is also developing VYN202, an oral BET inhibitor, for other serious, immune-mediated diseases, having previously evaluated it in a Phase 1b trial for moderate-to-severe plaque psoriasis.
Here's a quick look at the target patient population metrics:
| Metric | Value | Context/Date |
|---|---|---|
| Global Vitiligo Prevalence | Approx. 70 million people | As of early 2025 |
| Global Population Percentage | Approx. 1% | As of early 2025 |
| 7MM 12-Month Prevalence (Vitiligo) | 8.2 million cases | 2023 estimate |
| 7MM Treated Cases | Approx. 500K cases | 2023 estimate |
| US Share of 7MM Diagnosed Cases | Approx. 60% | As of early 2025 |
| VYN201 Phase 2b Trial Enrollment | Approx. 180 subjects | Enrolled as of January 2025 |
Dermatologists and rheumatologists treating these conditions.
This segment consists of the specialists who prescribe and manage treatments for chronic inflammatory and dermatological conditions. While specific numbers for the treating population are not public, the focus is on specialists managing the 8.2 million prevalent cases in the 7MM. The Phase 2b trial for VYN201 utilized 45 clinical sites in North America, indicating the geographic breadth of the required physician network for potential commercialization or partnership efforts. The development of VYN202 suggests a future need to engage rheumatologists for systemic inflammatory diseases, broadening the required specialist base beyond just dermatologists.
- The Phase 2b trial for repibresib gel involved 45 clinical sites in North America.
- The patient population requires specialists familiar with autoimmune depigmenting disorders and broader immuno-inflammatory conditions.
Institutional investors and financial analysts tracking clinical-stage biotech.
These stakeholders are crucial for funding VYNE Therapeutics Inc.'s operations, especially given its clinical-stage status. As of November 2025, institutional ownership is a significant factor, with the holding percentage fluctuating; for instance, it stood at 26.8% in June 2025 before dropping to 15.54% in November 2025. Insiders held 5.94%, and Mutual Funds held 4.19% in November 2025. The company's cash position as of September 30, 2025, was $32.7 million, which is projected to fund operations into the first half of 2027. Analysts track key financial events, such as the Q3 2025 net loss of $7.3 million and R&D expenses of $5.3 million for that quarter, against the cash runway to assess viability. Major institutional holders have included Eventide Asset Management LLC and Adage Capital Partners GP L.L.C. in the past, with reported transaction volumes in the millions of dollars.
Here's a snapshot of the ownership structure and recent financial health metrics:
| Metric | Value | As of Date |
|---|---|---|
| Cash, Cash Equivalents, Marketable Securities | $32.7 million | September 30, 2025 |
| Projected Cash Runway | Into first half of 2027 | Based on September 30, 2025 data |
| Net Loss (Q3 2025) | $7.3 million | Quarter ended September 30, 2025 |
| R&D Expenses (Q3 2025) | $5.3 million | Three months ended September 30, 2025 |
| Revenues (Q3 2025) | $0.2 million | Three months ended September 30, 2025 |
| Institutional Investors Holding | 15.54% | November 2025 |
Large pharmaceutical companies seeking pipeline assets (potential acquirers).
This segment represents potential strategic partners or acquirers. In August 2025, the Board of Directors initiated a strategic review to evaluate options, including strategic partnerships, licensing, merger, or acquisition transactions. Following the July 2025 announcement that the Phase 2b trial did not meet its primary endpoints, VYNE Therapeutics Inc. explicitly stated it would seek an external partner for the continued development of repibresib. This signals a strong, active interest in engaging with larger pharmaceutical entities that have the resources to advance the asset through later-stage trials and commercialization. The company has a history of engaging with this segment, having previously licensed the rights to Finacea® foam to LEO Pharma A/S.
- Strategic review initiated in August 2025 to explore M&A or licensing.
- Actively seeking an external partner for continued development of repibresib post-July 2025 data.
- Previous licensing activity with LEO Pharma A/S demonstrates prior engagement with large pharma.
VYNE Therapeutics Inc. (VYNE) - Canvas Business Model: Cost Structure
The cost structure for VYNE Therapeutics Inc. is heavily weighted toward the discovery, development, and regulatory navigation of its clinical pipeline assets, VYN201 and VYN202.
Dominant Research and Development (R&D) expenses represent a significant cash outlay, reported at \$16.3 million for the nine months ended September 30, 2025.
General and Administrative (G&A) overhead followed, totaling \$8.7 million for the same nine-month period ending September 30, 2025.
The cost profile for the third quarter of 2025 showed R&D expenses of \$5.3 million and G&A expenses of \$2.7 million, resulting in an operating loss of \$7.792 million for that quarter alone. The net loss for the nine months ended September 30, 2025, was \$21.6 million.
| Expense Category | Nine Months Ended Sep 30, 2025 (As Specified) | Three Months Ended Sep 30, 2025 (Actual) |
| Research and Development (R&D) | \$16.3 million | \$5.3 million |
| General and Administrative (G&A) | \$8.7 million | \$2.7 million |
| Total Operating Expenses (Approximate) | Not Directly Available | \$7.961 million |
Clinical trial costs were a major component of R&D spending, though subject to timing and program status. The termination of the repibresib (VYN201) Phase 2b trial in nonsegmental vitiligo following topline results in July 2025 impacted the expected expense trajectory for that program. Concurrently, costs were incurred for the ongoing 12-week, non-clinical toxicology study of VYN202 in dogs, initiated to address the partial clinical hold in male subjects.
Licensing and milestone payments are transactional costs tied to specific development achievements. VYNE Therapeutics Inc. made a \$1.0 million milestone payment to Tay in the third quarter of 2025 under an amendment to the VYN202 License Agreement. This payment resolved a dispute regarding the VYN202 Phase 2 milestone.
Personnel costs form a core part of both R&D and G&A spending, reflecting the need for specialized scientific, clinical, and management teams. For the three months ended September 30, 2025, the decrease in G&A expenses, which fell to \$2.7 million, was primarily driven by a decrease in employee-related expenses of \$0.2 million compared to the prior year period.
Specific drivers influencing the R&D cost base include:
- Decreased expenses for repibresib due to the trial termination.
- Decreased clinical expenses for Phase 1 trials evaluating VYN202.
- The \$1.0 million milestone payment to Tay, which partially offset the VYN202 expense decrease in Q3 2025.
- Costs associated with the repeat 12-week, non-clinical toxicology study for VYN202.
Cost discipline was a focus, as evidenced by the overall reduction in operating expenses year-over-year, which helped extend the projected cash runway into the first half of 2027 based on September 30, 2025, cash balances of \$32.7 million.
VYNE Therapeutics Inc. (VYNE) - Canvas Business Model: Revenue Streams
VYNE Therapeutics Inc.'s current revenue streams are minimal and primarily derived from legacy licensing agreements, reflecting its status as a clinical-stage company focused on pipeline development.
Minimal Royalty revenues totaled $0.44 million for the nine months ended September 30, 2025. This figure is the sum of quarterly royalty receipts from the Finacea® foam license.
The primary source of this recurring revenue is Royalties from the licensed Finacea® foam product (LEO Pharma A/S). The quarterly breakdown for the first three quarters of 2025 shows the following royalty income:
| Period Ended | Royalty Revenue (USD Thousands) |
| March 31, 2025 (Q1) | 202 |
| June 30, 2025 (Q2) | 69 |
| September 30, 2025 (Q3) | 169 |
For the six months ended June 30, 2025, the royalty revenues from LEO Pharma in connection with Finacea sales were $0.3 million.
The business model anticipates Potential future upfront and milestone payments from strategic partnerships. As an example of such a payment, a $1.0 million milestone payment was made to Tay in the third quarter of 2025 under an amendment to the VYN202 License Agreement.
The long-term revenue potential hinges on Future product sales, contingent on regulatory approval. This is dependent on the successful advancement of pipeline assets, specifically:
- Resolving the partial clinical hold for VYN202 in male subjects following an ongoing 12-week, non-clinical toxicology study in dogs.
- Securing a development and commercialization partner for the repibresib gel program after the Phase 2b trial termination.
As of September 30, 2025, VYNE Therapeutics Inc. had $32.7 million of cash, cash equivalents and marketable securities, which management believes is sufficient to fund operations into the first half of 2027.
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