Results of Dermatitis Clinical Trial Due This Summer

Enrollment is now done for VYNE Therapeutics Inc.’s Phase 2a trial following encouraging Phase 1b efficacy data, noted an H.C. Wainwright & Co. report.

VYNE Therapeutics Inc. (VYNE:NASDAQ) finished enrolling patients, on schedule, in the Phase 2a trial evaluating FMX114 in mild to moderate atopic dermatitis, and topline results are expected in late July-early August of this year, reported H.C. Wainwright & Co. analyst Joseph Pantginis in a June 17 research note.

Also of note, H.C. Wainwright’s target price on VYNE of $7 per share indicates a significant potential return for investors given the biopharma company’s current share price is around $0.50.

In Phase 2a, a double-blinded study, the 25 enrolled patients are to receive FMX114 and vehicle treatment four times a day for four weeks, Pantginis relayed. The objective is to further assess the safety, pharmacokinetics, and efficacy of the company’s proprietary tofacitinib and fingolimod combination gel formulation.

Pantginis highlighted that results from the Phase 1b portion of the Phase 1b/2a trial are encouraging. Patients showed a significant reduction in atopic dermatitis signs and symptoms after two weeks of FMX114 treatment. The therapeutic was shown to be safe, too.

In the report, Pantginis also provided updates on VYNE’s two immunomodulatory assets, VYN201 and VYN202. These are BET inhibitors derived from the InhiBET platform.

“BET proteins are key regulators of inflammation and oncogenesis via mechanisms of transcriptional modulation,” the analyst explained.

As for VYN201, a locally administered pan-bromodomain inhibitor, it “demonstrated robust preclinical efficacy in a number of inflammatory indications,” noted Pantginis. Newly released data on VYN201 show it safely provides immunosuppression.

VYNE intends to pursue VYN201 in vitiligo first, given the market potential, “impressive preliminary data” and significant unmet need, Pantginis wrote. “Current therapies for vitiligo are limited in their ability to generate a rapid response, are typically cumbersome for patients, and have limited durability.”

As such, the company is targeting H2/22 for the launch of a Phase 1a/b clinical trial of VYN201 in vitiligo.

“This is an important step forward for VYNE and its InhiBET platform, and we look forward to updates in the upcoming months,” Pantginis added.

Regarding VYNE’s later-stage, orally administered VYN202, the biopharma has yet to decide which systemic hyperinflammatory indication to pursue it in first, but the choices include rheumatoid arthritis, and systemic lupus erythematosus, ulcerative colitis/Crohn’s disease, and multiple sclerosis. VYNE is looking to commence, later this year, a Phase 1 trial of VYN202 in the indication it chooses.

H.C. Wainwright & Co. has a Buy rating on VYNE.

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Disclosures for H.C.Wainwright & Co., VYNE Therapeutics, Inc., June 17, 2022

H.C. Wainwright & Co, LLC (the “Firm”) is a member of FINRA and SIPC and a registered U.S. Broker-Dealer.

I, Joseph Pantginis, Ph.D. and Emanuela Branchetti, Ph.D. , certify that 1) all of the views expressed in this report accurately reflect my personal views about any and all subject securities or issuers discussed; and 2) no part of my compensation was, is, or will be directly or indirectly related to the specific recommendation or views expressed in this research report; and 3) neither myself nor any members of my household is an officer, director or advisory board member of these companies.

None of the research analysts or the research analyst’s household has a financial interest in the securities of VYNE Therapeutics, Inc. (including, without limitation, any option, right, warrant, future, long or short position). As of May 31, 2022 neither the Firm nor its affiliates beneficially own 1% or more of any class of common equity securities of VYNE Therapeutics, Inc.. Neither the research analyst nor the Firm knows or has reason to know of any other material conflict of interest at the time of publication of this research report.

The research analyst principally responsible for preparation of the report does not receive compensation that is based upon any specific investment banking services or transaction but is compensated based on factors including total revenue and profitability of the Firm, a substantial portion of which is derived from investment banking services. The firm or its affiliates received compensation from VYNE Therapeutics, Inc. for non-investment banking services in the previous 12 months. The Firm or its affiliates did not receive compensation from VYNE Therapeutics, Inc. for investment banking services within twelve months before, but will seek compensation from the companies mentioned in this report for investment banking services within three months following publication of the research report. The Firm does not make a market in VYNE Therapeutics, Inc. as of the date of this research report.

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