VYNE Therapeutics Inc. - VYNE STOCK NEWS

VYNE Therapeutics has announced positive Phase 1a single ascending dose (SAD) data for VYN202, its novel BD2-selective BET inhibitor. Key findings include:

1. Safety: VYN202 was generally well-tolerated across all dose groups with no drug-related adverse events.

2. Pharmacokinetics: Dose-dependent exposure of VYN202 in blood was observed.

3. Pharmacodynamics: Activity was noted on target engagement and inflammatory biomarkers.

The company has initiated the multiple ascending dose (MAD) portion of the trial, with results expected in Q4 2024. This data will inform planned studies in psoriasis and rheumatoid arthritis.

VYNE Therapeutics Inc. (Nasdaq: VYNE), a clinical-stage biopharmaceutical company, has announced its participation in two significant investor conferences in September 2024. The company, which focuses on developing therapies for chronic inflammatory and immune-mediated conditions, will attend:

1. The H.C. Wainwright 26th Annual Global Investment Conference from September 9-11 in New York, NY, where they will engage in one-on-one investor meetings.

2. The Stifel 2024 Virtual Immunology and Inflammation Summit on September 17-18, featuring a fireside chat presentation on Tuesday, September 17 at 8:30 AM ET, along with one-on-one investor meetings.

A webcast of the Stifel presentation will be available, with a replay accessible on VYNE's website for 90 days post-event.

VYNE Therapeutics Inc. (Nasdaq: VYNE) reported its Q2 2024 financial results and provided a business update. Key highlights include:

1. Initiation of a Phase 2b trial for VYN201 in nonsegmental vitiligo, with top-line results expected in mid-2025.

2. Ongoing Phase 1a SAD/MAD trial for VYN202, with data expected in Q3 and Q4 2024.

3. Cash position of $78.1 million as of June 30, 2024, expected to fund operations through the end of 2025.

4. Q2 2024 financial results: Revenue of $0.2 million, R&D expenses of $7.3 million, G&A expenses of $3.3 million, and a net loss of $9.4 million ($0.22 per share).

5. Appointment of Dr. Subhashis Banerjee as Senior VP of Clinical Development.

VYNE Therapeutics Inc. (Nasdaq: VYNE) has announced the granting of a composition of matter patent for VYN202, its novel BD2-selective BET inhibitor. The patent, GB Patent No. 2621505, was granted by the United Kingdom's Intellectual Property Office and covers the compound in VYNE's VYN202 program. The patent has a 20-year term expiring in June 2042.

David Domzalski, President and CEO of VYNE, emphasized the importance of this patent for the development of VYN202, which the company believes is the most potent and BD2-selective BET inhibitor in development. The patent is derived from Tay Therapeutics 's PCT application and is exclusively licensed to VYNE. This marks the first of the nationally filed applications to be granted, with VYNE seeking protection in additional jurisdictions as they progress their BET inhibitor pipeline.

VYNE Therapeutics has appointed Dr. Subhashis Banerjee as Senior Vice President of Clinical Development, effective July 8, 2024. Dr. Banerjee brings over 25 years of drug development experience, having worked on notable immunological therapies at Bristol Myers Squibb, Eli Lilly, Pfizer, and AbbVie. His expertise will be instrumental in advancing VYNE's strategy of developing BET inhibition treatments for immuno-inflammatory conditions. The company also announced the issuance of stock options to Dr. Banerjee and other employees as part of their 2024 Inducement Award Plan, with options priced at $1.96 per share.

VYNE Therapeutics, a clinical-stage biopharmaceutical company, announced its participation in the Leerink Partners Therapeutics Forum scheduled for July 9, 2024. The event will focus on Immunology & Inflammation (I&I) and Metabolic Diseases. VYNE will engage in one-on-one meetings to discuss their proprietary and innovative therapies for immuno-inflammatory conditions. The company aims to showcase its developments and strengthen its position within the biopharmaceutical field. This participation highlights VYNE's commitment to advancing treatments for critical health issues.

VYNE Therapeutics has initiated dosing in the Phase 1a trial of its novel BD2-selective BET inhibitor, VYN202. This first-in-human, double-blind, placebo-controlled study will enroll around 64 healthy volunteers to evaluate the safety, tolerability, pharmacokinetics, and pharmacodynamics of VYN202.

The trial includes single ascending dose (SAD) and multiple ascending dose (MAD) components, with top-line data expected in the second half of 2024. VYN202 aims to treat immuno-inflammatory diseases by selectively targeting the BD2 bromodomain of BET proteins, potentially offering a better benefit-risk profile.

Preclinical testing has shown promising results in reducing disease severity and biomarkers. VYNE is optimistic about VYN202's potential to address a range of immune-mediated diseases.

VYNE Therapeutics has commenced dosing the first subject in its Phase 2b trial for VYN201, a novel BET inhibitor gel, aimed at treating nonsegmental vitiligo. This 24-week, double-blind, vehicle-controlled study will evaluate the safety and efficacy of once-daily VYN201 gel in three concentrations: 1%, 2%, and 3%. Approximately 160 subjects will be randomized in a 1:1:1:1 ratio. Following the initial treatment period, active treatment subjects will continue for another 28 weeks, while vehicle group subjects will be re-randomized to one of the VYN201 concentrations. The study's primary endpoint is achieving a 50% improvement in the Facial Vitiligo Area Scoring Index (F-VASI50) at week 24. Top-line data are expected by mid-2025. Early Phase 1b results showed VYN201's rapid clinical response and favorable safety profile, suggesting it could become a differentiated therapy for vitiligo patients.

VYNE Therapeutics Inc. reported its First Quarter 2024 Financial Results and provided a business update. The company made steady progress on its VYN201 program towards a Phase 2b trial, with the design finalized. IND clearance was received for VYN202, with expectations to dose healthy volunteers in Phase 1a trial this quarter.

Financially, VYNE had $86.0 million in cash and marketable securities as of March 31, 2024, believed to be sufficient to fund operations through 2025. Revenues were $0.1 million for Q1 2024 and 2023, mainly from royalty revenue. Research and development expenses increased by 35.6%, and general and administrative expenses increased by 16.4%.