VYNE Therapeutics Reports Third Quarter 2022 Financial Results and Provides Business Update IND clearance received for pan-BD BET inhibitor, VYN201; Anticipate first patient to be enrolled in Phase 1a/b trial for Vitilig

VYNE Therapeutics Reports Third Quarter 2022

Financial Results and Provides Business Update

IND clearance received for pan-BD BET inhibitor,

VYN201; Anticipate first patient to be enrolled in Phase 1a/b trial

for Vitiligo this month

Continued progression of discovery and development

of oral, BD2 selective VYN202 program

Expanded analysis of FMX114 Phase 2a trial results

suggests FMX114 may have the potential to effectively treat

patients with moderate-to-severe atopic dermatitis; VYNE currently evaluating

development strategy for FMX114

BRIDGEWATER, N.J., November 10, 2022 -- VYNE Therapeutics Inc.

(Nasdaq: VYNE) ("VYNE" or the "Company"), a biopharmaceutical company focused on developing proprietary, innovative,

and differentiated therapies for the treatment of immuno-inflammatory conditions, today announced financial results for the three and

nine months ended September 30, 2022.

"The third quarter was pivotal for VYNE as we advanced toward

the first clinical trial for our InhiBETTM BET inhibitor platform," said David Domzalski, President and Chief Executive

Officer of VYNE. "We anticipate enrolling the first patient in our Phase 1a/b trial evaluating our pan-BD BET inhibitor, VYN201,

in vitiligo this month and look forward to reporting topline results in healthy volunteers and vitiligo patients in the first half of

2023. In addition, we have made considerable progress in the discovery and development of lead candidates for the VYN202 program with

our partner, Tay Therapeutics (formerly In4Derm). Finally, we completed further analyses on the Phase 2a data for FMX114 which showed

that while efficacy results were not statistically significant at week 4, the results were statistically superior at all other time points

including weeks 1, 2, and 3. Additionally, efficacy results continued to develop beyond week 4 throughout the open-label extension, and

the overall treatment effect of FMX114 as compared to vehicle increased when treating more severe disease. We will continue to evaluate

our development strategy for FMX114."

VYN201 -- VYN201 is a locally administered,

small molecule, pan-bromodomain and extra-terminal domain ("BET") inhibitor ("BETi") that is being developed for the

treatment of immuno-inflammatory diseases. VYNE expects to enroll the first patient in a Phase 1a/b clinical trial designed to generate

safety and pharmacokinetic data in healthy volunteers as well as provide early clinical proof-of-concept data in vitiligo patients in

November 2022. The Company expects topline data for both the Phase 1a and Phase 1b portions of the clinical trial in the first half of

The Phase 1 clinical trial will be conducted in

U.S.-based clinical centers. The Phase 1a portion of the clinical trial will evaluate single ascending/multiple ascending doses in up

to 30 healthy volunteers with VYN201 applied topically once daily for up to two weeks. The primary objective of this portion of the clinical

trial is to characterize the preliminary safety and pharmacokinetics of VYN201 and to determine the safe starting dose for the Phase 1b

portion of the clinical trial.

In the Phase 1b portion, up to 30 patients with

a clinical diagnosis of non-segmental vitiligo will receive VYN201 once daily in up to three dose cohorts initially for 8 weeks of treatment.

The primary objective of the Phase 1b segment of the clinical trial will be to evaluate the safety and pharmacokinetics of VYN201. In

addition, exploratory efficacy measures of VYN201 in non-segmental vitiligo patients will also be assessed. Clinical assessments will

include safety, pharmacokinetics, local skin tolerance, efficacy, pharmacodynamic biomarkers and photography.

VYN202 - VYN202 is being developed as

a highly-selective oral BET inhibitor designed to selectively bind to bromodomain 2 for the potential treatment of major

immuno-inflammatory diseases. VYNE is working with its license partner, Tay Therapeutics (formerly In4Derm Limited), to develop and

select a lead candidate. Following candidate selection, VYNE intends to exercise its option for this molecule and initiate

IND-enabling studies.

FMX114 -- FMX114 is VYNE's proprietary

investigational combination gel formulation of tofacitinib and fingolimod that is designed to address both the source and cause of inflammation

in atopic dermatitis ("AD"). On August 10, 2022, the Company announced that its Phase 2a clinical trial evaluating the safety

and efficacy of FMX114 for mild-to-moderate AD did not meet its primary endpoint, which was based on assessments of the absolute and percent

change relative to baseline in the atopic dermatitis severity index ("ADSI") scoring assessment at week 4. In the weeks that

followed, the Company performed additional analyses which showed that while efficacy results for FMX114 were not statistically significant

at week 4, FMX114 was statistically superior to vehicle at weeks 1, 2 and 3 in the Phase 2a trial. Additionally, data received from the

two-week open label extension during which both AD lesions of participating patients were treated with FMX114 showed that efficacy results

continued to develop beyond week 4 of the clinical trial and that the separation of treatment effect for lesions treated with FMX114 as

compared to lesions treated with vehicle increased for lesions that had a higher ADSI score at baseline. Accordingly, the Company believes

that FMX114 may have an improved overall treatment effect on patients with more severe disease at baseline, and that FMX114 may have increased

potential to effectively treat patients with more moderate-to-severe AD. In light of these analyses, the Company is currently evaluating

its development strategy for FMX114.

*See "Non-GAAP Financial Measures" elsewhere in this earnings

Liquidity and Capital Resources

As of September 30, 2022, VYNE had cash and cash equivalents and

restricted cash of $35.6 million. Additionally, VYNE is entitled to receive a $5.0 million payment in January 2023 from Journey in

connection with the sale of the MST Franchise.

VYNE currently anticipates that its cash and cash equivalents and restricted

cash as of September 30, 2022 will be sufficient to fund its operations into the fourth quarter of 2023, without giving effect to any

potential business development transactions or financing activities, including any sales under our equity line of credit with Lincoln

Park or our at-the-market offering program. See Note 1 to VYNE's unaudited interim condensed consolidated financial statements included

in VYNE's Quarterly Report on Form 10-Q for the quarter ended September 30, 2022 for additional discussion on liquidity and capital

Financial Results for the Third Quarter Ended September 30,

Due to the sale of the MST Franchise during the first quarter of

2022, the Company has classified the results of the MST Franchise as discontinued operations in its unaudited interim condensed consolidated

statements of operations for all periods presented. See Note 3 to VYNE's unaudited interim condensed consolidated financial statements

included in VYNE's Quarterly Report on Form 10-Q for the third quarter ended September 30, 2022 for additional discussion on

discontinued operations.

Revenues. Revenues for the three months ended September 30,

2022 were $0.2 million compared to $0.1 million in the three months ended September 30, 2021. Revenues were comprised of royalty

VYNE divested the MST Franchise on January 12,

2022. As a result of the sale, the Company will not generate revenue from the sales of AMZEEQ or ZILXI following such date.

Research and development expenses. VYNE's research

and development expenses for the three months ended September 30, 2022 were $5.5 million compared to $5.9 million for the three

months ended September 30, 2021, representing a decrease of $0.4 million, or 6.3%. The decrease was primarily driven by a

decrease in employee-related expenses of $1.3 million and a reduction of other R&D related activities of $0.3 million,

partially offset by the option extension payment for the oral BETi of $1.0 million and increased spending on VYN201 of

Selling, general and administrative expenses.

VYNE's selling, general and administrative expenses for the three months ended September 30, 2022 were $4.0 million compared

to $5.0 million for the three months ended September 30, 2021, representing a decrease of $1.0 million, or 20.7%. The decrease

was primarily driven by a reduction of $0.6 million in consulting expenses and decreased employee-related expenses of $0.4 million.

Net loss. Net loss for the three

months ended September 30, 2022 was $9.5 million compared to a net loss of $21.3 million for the three months ended September 30,

2021. Loss from continuing operations was $9.3 million for the three months ended September 30, 2022 compared to $14.3 million

for the prior year period. Loss from discontinued operations was $0.2 million for three months ended September 30, 2022 compared

to a loss from discontinued operations of $7.0 million for the three months ended September 30, 2021.

About VYNE Therapeutics

VYNE's mission 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 bromodomain & extra-terminal (BET) domain platform includes lead programs VYN201 (pan-BETi) and VYN202 (selective-BETi),

and access to a library of small molecule BET inhibitors for the potential treatment of immuno-inflammatory conditions licensed from Tay

Therapeutics Limited.

For more information about VYNE Therapeutics Inc.