Earnings release
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VYNE TM THERAPEUTICS Exhibit 99.1 VYNE Therapeutics Reports Third Quarter 2021 Financial Results and Provides Business Update Lead BET Inhibitor Candidate , VYN201 , Demonstrates Potent Anti - Inflammatory Effect in Preclinical Studies VYN201 Expected to Enter Clinic in 2022 Phase 2a Results for FMX114 in Mild - to - Moderate Atopic Dermatitis Expected Early Q1 2022 Process for Sale of Topical Minocycline Franchise Continues to Advance Conference call and Live Webcast Today at 8:30 am Eastern Time BRIDGEWATER , N.J. , November 10 , 2021 -- VYNE Therapeutics Inc. ( Nasdaq : VYNE ) ( " VYNE " or the " Company " ) today announced financial results for the third quarter ended September 30 , 2021 and provided a business update . " The third quarter marks an important turning point for VYNE , as our company is now fully engaged in the development of next - generation therapeutics designed to address multiple immuno - inflammatory diseases , " said David Domzalski , CEO of VYNE . " Based upon a growing body of preclinical data , we believe the evolving therapeutic profile for the BET inhibitor drug class represents a potential breakthrough in the treatment of immuno - inflammatory diseases . Our lead candidate , VYN201 , is demonstrating a strong ability to effect multiple pro - inflammatory pathways while also appearing to be well tolerated in animal models . As we move toward 2022 , creating shareholder value remains front and center for our company and we look forward to our Phase 2a data readout for FMX114 in Q1 2022 and advancing our lead BET inhibitor candidates . " Pipeline Update VYN201 , Topical BET Inhibitor Program : On October 26 , 2021 and November 4 , 2021 , VYNE announced data from preclinical studies showing that its pan - bromodomain BET inhibitor , VYN201 , significantly reduced the expression of several key pro - inflammatory cytokines relevant to Th17 - mediated autoimmune diseases and demonstrated improvement in reducing fibrotic tissue mass and overall skin repair outcomes . Key highlights from the preclinical studies include : VYN201 exhibited anti - inflammatory effect similar to super - potent glucocorticosteroids . VYN201 appeared well - tolerated in mice , as seen through animal body weight and skin condition . VYN201 also demonstrated stronger inhibition of key Th17 cytokines in ex vivo data with human skin tissue when directly compared to JAK1 / 2 inhibitor , ruxolitinib . VYN201 , demonstrated improvements in reducing fibrotic tissue mass and overall skin repair outcomes with no negative impact on healing time , supporting the continued progression of the VYN201 development program . Following the completion of the prerequisite IND - enabling non - clinical safety assessments , the Company intends to communicate the initial indication it will be pursuing for VYN201 and expects to enter the program into the clinic in 2022 . VYN202 , Oral BET Inhibitor Program : VYN202 is an orally delivered , first - in - class BET inhibitor that is highly selective for Bromodomain 2 ( " BD2 " ) . By selectively inhibiting BD2 , the Company believes VYN202 could have a more targeted anti - inflammatory effect with an improved benefit / risk profile . Upon the selection of a lead candidate , VYNE intends to exercise its exclusive option with In4Derm Limited and commence an IND - enabling non - clinical safety program .