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VYNE Therapeutics Completes Enrollment in Phase 2a Trial of FMX114 for the Treatment of Mild-to-Moderate Atopic Dermatitis Top-line Efficacy Results Expected in Approximately 6 to 8 Weeks BRIDGEWATER, N.J.

Key Takeaway: VYNE Therapeutics Completes Enrollment in Phase 2a Trial of FMX114 for the Treatment of Mild-to-Moderate Atopic Dermatitis Top-line Efficacy Results Expected in Approximately BRIDGEWATER, N.J., June 17, 2022 -- VYNE Therapeutics Inc. (Nasdaq: VYNE) ("VYNE" or the "Company"),

Full Press Release Details

VYNE Therapeutics Completes Enrollment in Phase
2a Trial of FMX114 for the Treatment of Mild-to-Moderate Atopic Dermatitis
Top-line Efficacy Results Expected in Approximately
BRIDGEWATER, N.J., June 17, 2022 -- VYNE
Therapeutics Inc. (Nasdaq: VYNE) ("VYNE" or the "Company"), a biopharmaceutical company developing proprietary,
innovative, and differentiated therapies for the treatment of immuno-inflammatory conditions, today announced the completion of enrollment
in the Phase 2a study of FMX114 for the treatment of mild-to-moderate atopic dermatitis ("AD").
FMX114 is VYNE's proprietary investigational
combination gel formulation of tofacitinib and fingolimod, which has been designed to address both the source and cause of inflammation
in AD. In April 2022, VYNE reported positive efficacy data from the Phase 1b segment of the trial, demonstrating that treatment
with FMX114 resulted in a statistically significant reduction in both absolute and percent change in mean Atopic Dermatitis Severity
Index ("ADSI") score compared to vehicle. FMX114 treatment also substantially reduced pruritus (itch) as measured on the
worst pruritus Numerical Rating Scale ("NRS").
The Phase 2a segment
of the FMX 114 study is designed to evaluate four weeks of FMX114 treatment in patients with AD compared to vehicle control. Due to the
impact of COVID-19 on enrollment and other operations related to the original trial sites in Australia, the Company activated additional
clinical trial sites in the United States to support patient enrollment and expedite completion of the study. With enrollment now completed,
the Company expects to report top-line efficacy results in approximately 6 to 8 weeks.
"We have been encouraged
by the early efficacy results from the Phase 1b segment of the FMX114 trial showing that, based on ADSI scoring, two weeks of FMX114 treatment
demonstrated a statistically significant improvement in the signs and symptoms of AD as well as acceptable safety and pharmacokinetics,"
said David Domzalski, Chief Executive Officer of VYNE Therapeutics. "We look forward to reporting the results of the Phase 2a segment
of the study in approximately 6 to 8 weeks."
About The FMX114 2a study (VY2021-01, ClinicalTrials.gov
Identifier: NCT04927572)
The Phase 2a segment
of the study is a randomized, double-blinded trial, designed to compare the safety and efficacy of FMX114 gel with vehicle gel. The Phase
2a segment was designed to enroll up to 25 subjects, with each subject serving as their own control. As in the Phase 1b study, the enrollment
criteria specifies that subjects must have two comparable target AD lesions for treatment upon entry. Participants will have FMX114 gel
applied to one of these lesions and vehicle gel to the other. Treatment will be applied twice daily for four weeks to evaluate safety,
pharmacokinetics and efficacy. After completion of this phase, these subjects may continue into a two-week open-label treatment phase
and will be able to apply the active drug to both lesions. The study is being conducted at sites in Australia and in the United States.
proprietary investigational combination gel formulation of tofacitinib and fingolimod. The product is designed to address both the source
and cause of inflammation in AD through a combination of tofacitinib (a Janus kinase inhibitor) that acts with cells to reduce inflammation
by inhibiting cytokine release from inflammatory cells2) and fingolimod (a Sphingosine 1-phosphate receptor modulator) that
acts outside of cells to reduce inflammation by inhibiting migration of inflammatory cells3. In addition, fingolimod may also
directly support skin barrier recovery because it is known to upregulate filaggrin, a protein that plays an important role in the skin's
barrier function4,5. FMX114 has the potential to be the first topical combination product for the treatment of AD as well as
the first topical product in clinical development that utilizes the sphingosine 1-phosphate receptor modulation mode of action.
About Atopic Dermatitis
Atopic dermatitis (AD)
is a chronic, severe form of eczema that is characterized by the appearance of dry, red, and itchy skin. AD most commonly affects the
cheeks, arms, and legs. Flare-ups often occur and symptoms can worsen leading to more-intense itching and worsening of disease. AD flares
are triggered by stress, temperature changes, sweat, various skin irritants, and allergies. AD can have a wide-ranging impact on quality
of life and there is a substantial monetary burden from direct and indirect costs to this patient population. While AD occurs most often
in childhood, it can develop at any point in a person's lifetime and affects approximately 30 million people in the U.S. alone.
Approximately 22 million of those diagnosed are on treatment, with 19 million registering mild to moderate disease. According to Symphony
Health data, there were over 7 million prescriptions written in 2019 alone for the treatment of AD.
About VYNE Therapeutics Inc.
is to improve the lives of patients by developing proprietary, innovative, and differentiated therapies for the treatment of immuno-inflammatory
conditions. The Company's unique and proprietary pipeline includes FMX114 for the potential treatment of mild-to-moderate atopic
dermatitis, and access to a library of bromodomain & extra-terminal (BET) domain inhibitors licensed from In4Derm Limited. The BET
inhibitor platform includes lead programs VYN201 (pan-BETi) and VYN202 (selective-BETi) and access to a library of (BET) domain inhibitors
for the potential treatment of immuno-inflammatory conditions.
For more information about VYNE Therapeutics Inc.
or its investigational products, visit www.vynetherapeutics.com. 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.
LifeSci Advisors, LLC
VYNE Therapeutics Inc.
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 of VYNE's product candidate, 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: the timing and outcome of
the Phase 2a clinical trial for FMX114; determination by the FDA that results from VYNE's preclinical and clinical trials are not
sufficient to support registration or marketing approval of product candidates; adverse events associated with the development of FMX114
and VYNE's other product candidates; the COVID-19 pandemic and its impact on our business operations and liquidity, including our
ability to enroll patients and progress clinical trials; the size of the atopic dermatitis market; the potential patient base and commercial
potential of FMX114 or any of VYNE's other 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; and VYNE's ability to stay in compliance with applicable laws, rules and regulations, including Nasdaq's
continued listing rules. 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, 2021, 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.
Last updated: Jun 17, 2022