Company Overview - VYNE Therapeutics Inc. is a clinical-stage biopharmaceutical company focused on developing differentiated therapies for chronic inflammatory and immune-mediated conditions with high unmet need [3]. Upcoming Investor Conferences - VYNE's management will participate in two investor conferences in March 2025: - TD Cowen 45th Annual Health Care Conference in Boston, MA on March 4, 2025, featuring a fireside chat and one-on-one meetings [1]. - Leerink Partners Global Healthcare Conference in Miami, FL on March 11, 2025, consisting of one-on-one meetings [2]. Product Development - VYNE's proprietary BET inhibitors, part of its InhiBET™ platform, aim to address limitations of early generation BET inhibitors by utilizing alternative routes of administration and enhanced selectivity [3].

Core Insights - VYNE Therapeutics Inc. has initiated a Phase 1b trial for VYN202, an oral small molecule BET inhibitor, targeting moderate-to-severe plaque psoriasis, marking a significant advancement in its clinical development [1][2][3] - The trial aims to evaluate the safety, tolerability, and pharmacokinetics of VYN202 over a 12-week period, with top-line data expected by the end of 2025 [1][3][6] Company Overview - VYNE Therapeutics is a clinical-stage biopharmaceutical company focused on developing therapies for chronic inflammatory and immune-mediated conditions with high unmet needs [9] - The company’s proprietary BET inhibitors, including VYN202, are designed to overcome limitations of earlier generation BET inhibitors through enhanced selectivity and alternative administration routes [9] Product Details - VYN202 is characterized as a highly selective oral BET inhibitor with potential advantages in treating immune-mediated diseases due to its class-leading selectivity for BD2 over BD1 [5][6] - The Phase 1b trial will include three dosing cohorts (0.25 mg, 0.5 mg, 1 mg) and will assess exploratory efficacy measures such as PASI scores and quality of life [3][4] Disease Context - Plaque psoriasis is a chronic immune-mediated disease affecting over 8 million Americans and more than 125 million people globally, characterized by inflamed, scaly plaques [4] - The disease shares common inflammatory pathways with other chronic conditions, suggesting potential broader applications for VYN202 in treating various immune-mediated diseases [4][2]

Core Insights - VYNE Therapeutics Inc. has completed enrollment in its Phase 2b trial for VYN201 gel, aimed at treating nonsegmental vitiligo, with top-line data expected in mid-2025 [1][2][8] Company Overview - VYNE Therapeutics Inc. is a clinical-stage biopharmaceutical company focused on developing differentiated therapies for chronic inflammatory and immune-mediated conditions with high unmet needs [9] - The company utilizes a proprietary InhiBET™ platform, which includes unique BET inhibitors designed to enhance selectivity and overcome limitations of earlier generation BET inhibitors [9] Product Development - The Phase 2b trial for VYN201 gel (now named repibresib) is a randomized, double-blind, vehicle-controlled study assessing the efficacy, safety, and pharmacokinetics of the gel in three dose cohorts (1%, 2%, and 3%) over a 24-week period [3][4] - The primary efficacy endpoint is the proportion of subjects achieving at least a 50% improvement in the Facial Vitiligo Area Scoring Index (F-VASI50) at week 24 compared to the vehicle group [4] Disease Context - Vitiligo is a chronic autoimmune disorder characterized by the loss of melanocytes, affecting approximately 0.5-2.0% of the global population, with nonsegmental vitiligo being the most common type [5] - Currently, there is only one FDA-approved treatment for vitiligo, highlighting the significant unmet medical need in this area [5] Mechanism of Action - Repibresib is a pan-bromodomain BET inhibitor designed for local administration, targeting multiple inflammatory cell signaling pathways while minimizing systemic exposure [6] - BET proteins play a crucial role in regulating gene transcription and immune cell activation, making BET inhibitors promising for treating various immuno-inflammatory and fibrotic diseases [7]

Core Insights - VYN202 shows promising results as a novel, once-daily oral treatment for various immune-mediated disorders, demonstrating a favorable safety and tolerability profile [1][3] - The Phase 1a trial results indicate robust pharmacodynamic activity, including significant inhibition of inflammatory biomarkers [1][2] Safety and Tolerability - VYN202 exhibited no drug-related adverse events historically associated with earlier generation BET inhibitors, such as thrombocytopenia and gastrointestinal toxicity [2][4] - All treatment-emergent adverse events (TEAEs) were mild or moderate, with no serious adverse events reported [2][3] Pharmacokinetics (PK) - VYN202 supports a once-daily dosing regimen, achieving steady-state after 7 doses [2][4] - Blood levels of VYN202 remained within key inhibitory thresholds for at least 24 hours across all doses [2][4] - No drug-drug interactions were observed when co-administered with methotrexate [2][4] Pharmacodynamics - VYN202 induced a dose-dependent increase in the target engagement biomarker HEXIM-11, with maximal effects at doses of 0.5mg to 1.0mg [2][5] - The drug inhibited multiple inflammatory biomarkers related to Th17 and Th1/myeloid dysregulated activity, consistent with preclinical models [2][6] Development and Future Plans - The positive results from the Phase 1a trial support further development of VYN202 as a treatment option for immune-mediated diseases [3][9] - The company plans to finalize clinical trial plans for VYN202 based on these encouraging results [3][9] About VYN202 - VYN202 is an innovative oral small molecule BET inhibitor designed for enhanced selectivity and potency, particularly for BD2 versus BD1 [6][9] - It aims to provide a differentiated, non-biologic treatment option for chronic inflammatory conditions [6][9]

Financial Performance - As of September 30, 2024, the company has an accumulated deficit of $719.1 million, with net losses of $27.8 million and $22.3 million for the nine months ended September 30, 2024 and 2023, respectively[133]. - Total revenues for the three months ended September 30, 2024, were $0.121 million, a 6.1% increase from $0.114 million in the same period of 2023[149]. - Operating loss for the three months ended September 30, 2024, was $(13.091) million, a 110.0% increase from $(6.234) million in the same period of 2023[149]. - Net loss for the three months ended September 30, 2024, was $(12.157) million, an 84.6% increase from $(6.584) million in the same period of 2023[149]. - Total revenues for the nine months ended September 30, 2024, were $0.417 million, a 19.8% increase from $0.348 million in the same period of 2023[157]. - Net loss for the nine months ended September 30, 2024, was $(27.812) million, a 24.9% increase from $(22.264) million in the same period of 2023[156]. Research and Development - Total research and development expenses for the three months ended September 30, 2024 and 2023 were $10.2 million and $3.3 million, respectively, while for the nine months ended September 30, 2024 and 2023, they were $21.3 million and $13.3 million, respectively[144]. - Research and development expenses for the three months ended September 30, 2024, were $10.248 million, representing a 208.9% increase from $3.318 million in the same period of 2023[151]. - Research and development expenses for the nine months ended September 30, 2024, were $21.262 million, a 60.1% increase from $13.284 million in the same period of 2023[158]. - Research and development expenses are now identified as a critical accounting policy, reflecting the company's focus on innovation and development[182]. Clinical Trials - The company initiated a Phase 1 clinical trial for VYN201 in November 2022, with positive data reported from the Phase 1b trial on October 30, 2023, showing significant clinical improvement in F-VASI after 16 weeks of treatment[130]. - The Phase 2b trial of VYN201 is expected to enroll approximately 40 to 50 patients in each arm, with top-line results anticipated in mid-2025[130]. - The company expects to report top-line results from the MAD portion of the VYN202 trial in the fourth quarter of 2024, with further trials planned for moderate-to-severe plaque psoriasis and rheumatoid arthritis[131]. Financial Position and Cash Flow - As of September 30, 2024, the company had cash, cash equivalents, restricted cash, and marketable securities totaling $70.2 million[164]. - The company anticipates needing additional capital to fund operations and product development due to ongoing losses and negative cash flows[163]. - Net cash used in operating activities for the nine months ended September 30, 2024, was $25.0 million, compared to $20.2 million for the same period in 2023, reflecting a 24% increase in cash outflow[174][175]. - Net cash provided by investing activities for the nine months ended September 30, 2024, was $10.6 million, significantly higher than $5.0 million in 2023, representing a 112% increase[177][178]. - Cash inflows from the sale and maturity of marketable securities amounted to $61.1 million in 2024, while $50.5 million was spent on purchasing marketable securities[177]. Licensing and Partnerships - The company has entered into a license agreement with Tay for the VYN201 program, with potential milestone payments of up to $15.75 million, of which $1.8 million has been paid or accrued through September 30, 2024[138]. - For the VYN202 program, the company has agreed to make cash payments of up to $43.75 million upon achieving specified milestones, with $1.3 million paid or accrued through September 30, 2024[140]. - The company is focused on advancing its immuno-inflammatory pipeline and may seek partnerships with larger pharmaceutical companies to enhance development efforts[132]. Accounting Policies and Disclosures - The company has not reported any off-balance sheet arrangements that could materially affect its financial condition or operations[186]. - There have been no material changes to critical accounting policies for the nine months ended September 30, 2024, except for the reclassification of certain policies[181]. - The company continues to make estimates regarding accrued research and development expenses, which may vary based on actual service performance[185]. - The company is classified as a smaller reporting company and is not required to provide certain market risk disclosures[188].

Group 1 - VYNE Therapeutics Inc. reported a quarterly loss of $0.29 per share, which was worse than the Zacks Consensus Estimate of a loss of $0.24, representing an earnings surprise of -20.83% [1] - The company posted revenues of $0.12 million for the quarter ended September 2024, exceeding the Zacks Consensus Estimate by 10%, and showing a slight increase from $0.11 million in the same quarter last year [2] - VYNE Therapeutics shares have increased approximately 34.3% since the beginning of the year, outperforming the S&P 500's gain of 24.3% [3] Group 2 - The earnings outlook for VYNE Therapeutics is mixed, with the current consensus EPS estimate for the coming quarter at -$0.26 on revenues of $0.2 million, and for the current fiscal year at -$0.86 on revenues of $0.6 million [7] - The Medical - Drugs industry, to which VYNE Therapeutics belongs, is currently ranked in the top 33% of over 250 Zacks industries, indicating a favorable outlook compared to the bottom 50% [8]

Core Insights - VYNE Therapeutics Inc. announced positive results from the single ascending dose (SAD) portion of its Phase 1a trial for VYN202, a novel BET inhibitor targeting chronic inflammatory and immune-mediated conditions [1][6] Group 1: Trial Results - VYN202 was generally well tolerated across all dose groups, with no serious or drug-related adverse events reported [2] - Pharmacokinetic results showed a dose-dependent increase in plasma and urine concentrations of VYN202 [3] - Pharmacodynamic analysis indicated an increase in the HEXIM1 protein, suggesting effective target engagement, along with a biological activity that inhibited inflammatory biomarkers relevant to psoriasis and rheumatoid arthritis [4] Group 2: Future Developments - The multiple ascending dose (MAD) portion of the trial has commenced, with results anticipated in Q4 2024 [5] - The MAD trial aims to further assess safety, tolerability, pharmacokinetics, and pharmacodynamics over a 14-day period at varying dose levels [5] Group 3: Product Overview - VYN202 is an innovative oral small molecule BET inhibitor with potential class-leading selectivity for BD2 over BD1, aiming to provide a non-biologic treatment option for immuno-inflammatory conditions [7] - The compound is distinct from VYNE's previous pan-BET inhibitor, VYN201, and is protected by unique patent applications [7] Group 4: Industry Context - BET inhibitors are recognized for their role in regulating gene transcription and immune cell activation, presenting opportunities for treating various immuno-inflammatory and fibrotic diseases [8][9]

UNITED STATES SECURITIES AND EXCHANGE COMMISSION WASHINGTON, D.C. 20549 FORM 10-Q ☒ QUARTERLY REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 FOR THE QUARTERLY PERIOD ENDED JUNE 30, 2024 OR ☐ TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(D) OF THE SECURITIES EXCHANGE ACT OF 1934 FOR THE TRANSITION PERIOD FROM ___ TO ___. Commission file number 001-38356 VYNE THERAPEUTICS INC. (Exact name of registrant as specified in its charter) Delaware 45-3757789 (State or other jurisdictio ...

VYNE Therapeutics Inc. (VYNE) came out with a quarterly loss of $0.22 per share versus the Zacks Consensus Estimate of a loss of $0.19. This compares to loss of $3.08 per share a year ago. These figures are adjusted for non-recurring items. This quarterly report represents an earnings surprise of -15.79%. A quarter ago, it was expected that this company would post a loss of $0.24 per share when it actually produced a loss of $0.15, delivering a surprise of 37.50%. Over the last four quarters, the company ha ...

Initiated Phase 2b trial of VYN201 in nonsegmental vitiligo, with top-line results expected in mid-2025 Phase 1a SAD/MAD trial of VYN202 progressing, with data from the SAD and MAD portions expected in Q3 and Q4 2024, respectively Balance sheet expected to fund key clinical milestones for VYN201 and VYN202 through the end of 2025 BRIDGEWATER, N.J., Aug. 14, 2024 (GLOBE NEWSWIRE) -- VYNE Therapeutics Inc. (Nasdaq: VYNE) ("VYNE" or the "Company"), a clinical-stage biopharmaceutical company focused on developi ...