VYNE Therapeutics Announces Formation of Scientific Advisory Board

10/21, 2:00 PM (Source: GlobeNewswire)

Renowned Experts to Support VYNE’s Strategy of Developing Novel Treatments for Immunological and Inflammatory diseases

SAB to Help Guide Clinical Development of VYNE’s BET Inhibitor Drug Candidates

BRIDGEWATER, N.J., Oct. 21, 2021 (GLOBE NEWSWIRE) -- VYNE Therapeutics Inc. (Nasdaq: VYNE) (“VYNE” or the “Company”) today announced the formation of its Scientific Advisory Board (SAB) composed of leading scientists and clinicians specializing in immunological and inflammatory diseases.

The SAB will provide scientific expertise and guidance to the VYNE management team and Board as the Company progresses its pipeline of innovative treatments for immuno-inflammatory conditions. These include the novel class of bromodomain and extra-terminal (BET) inhibitor compounds licensed through VYNE’s recent collaboration with In4Derm Limited, as well as FMX114 for the potential treatment of mild-to-moderate atopic dermatitis.

“We recently announced our new strategic direction to focus on advancing our proprietary pipeline and develop treatments for immunological and inflammatory diseases,” said David Domzalski, CEO of VYNE. “The establishment of the SAB is an important step in our development plans, and we are delighted to welcome this team of esteemed and world-renowned medical experts who bring significant expertise, highly complementary skills and an external perspective.”

BET proteins play a key role in regulating gene transcription via epigenetic interactions (“reading”), and recent research has determined a key role for these BET proteins in regulating B cell and T cell activation and subsequent inflammatory processes. As epigenetic readers, BET proteins regulate the recruitment of transcriptional factors that are key to the production of pro-inflammatory cytokines. Inhibiting BET proteins blocks cytokine transcription and therefore may have significant therapeutic potential across several immuno-inflammatory conditions.

Iain Stuart, Chief Scientific Officer at VYNE, said “The SAB’s immediate focus is our recently licensed BET inhibitor platform. With the SAB’s appointment, VYNE will have access to the leading advisors from several therapeutic areas of interest for immunological and inflammatory conditions, which will optimize the development of our BET pipeline of highly differentiated treatments for these diseases.”

VYNE’s SAB is comprised of:

Roy M. Fleischmann, M.D. Clinical Professor of Medicine at UT Southwestern Medical Center in Dallas, Texas, Co-Medical Director of the Metroplex Clinical Research Center in Dallas, and Co-Director of the Division of Rheumatology at Presbyterian Medical Center in Dallas Master of the American College of Rheumatology.

Martin M. Okun, M.D., Ph.D. Former Dermatology Team Leader in the Division of Dermatologic and Dental Products at the FDA, Former Senior Medical Director at Abbott/AbbVie and Practicing dermatologist.

David B. Sachar, M.D. Clinical Professor of Medicine and Director Emeritus of the GI Division at Mount Sinai School of Medicine. Former Chair of the Research Development Committee of the Crohn's and Colitis Foundation of America, Founding director of the Burrill B. Crohn Research Foundation, Former Chairman of the International Organization for the Study of Inflammatory Bowel Disease.

Olaf Stuve, M.D., Ph.D. Professor at UT Southwestern Medical Center and Chief of Neurology at the VA North Texas Health Care System/Dallas VA Medical Center. He is a fellow of the American Neurological Association, the American Academy of Neurology, and the European Academy of Neurology.

Johnathan R. Whetstine, Ph.D. Professor, Co-Leader of the Cancer Signaling and Epigenetics Program, and Director of the Cancer Epigenetics Institute at Fox Chase Cancer Center. Dr. Whetstine is credited with the discovery of the first histone lysine demethylase and made contributions to the field that have aided in the understanding of tumor heterogeneity and drug response.

Additional information and biographies are available at: https://vynetherapeutics.com/who-we-are/

About VYNE Therapeutics Inc.
VYNE’s mission is to improve the lives of patients by developing proprietary, innovative, and differentiated therapies for the treatment of immuno-inflammatory conditions.

With expertise in topical medicine innovation as a springboard, VYNE is working to develop and commercialize a variety of therapies for major immuno-inflammatory conditions and rare skin diseases with high unmet medical need. The Company’s unique and proprietary pipeline includes Phase 3 ready FCD105 (3% minocycline and 0.3% adapalene) for the treatment of moderate-to-severe acne vulgaris, FMX114 for the treatment of mild-to-moderate atopic dermatitis and a library of bromodomain & extra-terminal domain inhibitors in both topical and oral forms for the treatment of major immuno-inflammatory conditions and rare skin diseases. VYNE has received FDA approval for AMZEEQ® (minocycline) topical foam, 4%, the world’s first topical minocycline, and for ZILXI® (minocycline) topical foam, 1.5%, the first minocycline product of any kind to be approved by the FDA for use in rosacea. For more information about our approved products, please see AMZEEQ’s Full Prescribing Information at AMZEEQ.com and ZILXI’s Full Prescribing Information at ZILXI.com.

For more information about VYNE Therapeutics Inc. or its investigational products, visit www.vynetherapeutics.com or follow VYNE on Twitter. VYNE may use its website to comply with its disclosure obligations under Regulation FD. Therefore, investors should monitor VYNE’s website in addition to following its press releases, filings with the U.S. Securities and Exchange Commission, public conference calls, and webcasts.

CONTACT:
Joyce Allaire
LifeSci Advisors, LLC
646-889-1200
jallaire@lifesciadvisors.com

Tyler Zeronda
Chief Financial Officer
VYNE Therapeutics
908-458-9106
Tyler.Zeronda@vynetx.com

Cautionary Statement Regarding Forward-Looking Statements
This release includes forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995, including, but not limited to, statements regarding the development and commercialization of VYNE’s products and product candidates, including the BET Inhibitor programs and FMX114, and other statements regarding the future expectations, plans and prospects of VYNE. All statements in this press release which are not historical facts are forward-looking statements. Any forward-looking statements are based on VYNE’s current knowledge and its present beliefs and expectations regarding possible future events and are subject to risks, uncertainties and assumptions that could cause actual results to differ materially and adversely from those set forth or implied by such forward-looking statements. These risks and uncertainties include, but are not limited to: VYNE’s ability to sell or license the topical minocycline franchise on acceptable terms in a timely manner or at all; VYNE’s ability to successfully finance and develop the BET Inhibitor platform and FMX114; the COVID-19 pandemic and its impact on our business operations and liquidity, including the ability to progress a preclinical or clinical trial; adverse events associated with the development and commercialization of our product candidates and approved products; the outcome and cost of pre-clinical and clinical trials for current and future product candidates; determination by the FDA that results from VYNE’s pre-clinical and clinical trials are not sufficient to support registration or marketing approval of product candidates; the eligible patient base and commercial potential of VYNE’s product candidates; risks of potential litigation by third-parties regarding infringement of third-party intellectual property; risks that VYNE’s intellectual property rights, such as patents, may fail to provide adequate protection, may be challenged and one or more claims may be revoked or interpreted narrowly or will not be infringed; risks that any of VYNE’s patents may be held to be narrowed, invalid or unenforceable or one or more of VYNE’s patent applications may not be granted and potential competitors may also seek to design around VYNE’s granted patents or patent applications; additional competition in the markets in which we compete; inability to raise additional capital on favorable terms or at all; VYNE’s ability to recruit and retain key employees; volatility in our stock price may result in rapid and substantial increases or decreases in our stock price that may or may not be related to our operating performance or prospects; and VYNE’s ability to stay in compliance with applicable laws, rules and regulations. For a discussion of other risks and uncertainties, and other important factors, any of which could cause VYNE’s actual results to differ from those contained in the forward-looking statements, see the section titled “Risk Factors” in VYNE’s Annual Report on Form 10-K for the year ended December 31, 2020, as well as discussions of potential risks, uncertainties, and other important factors in VYNE’s subsequent filings with the U.S. Securities and Exchange Commission. Although VYNE believes these forward-looking statements are reasonable, they speak only as of the date of this announcement and VYNE undertakes no obligation to update publicly such forward-looking statements to reflect subsequent events or circumstances, except as otherwise required by law. Given these risks and uncertainties, you should not rely upon forward-looking statements as predictions of future events.


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