Earnings release
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VYNE ™ THERAPEUTICS Exhibit 99.1 VYNE Therapeutics Reports Second Quarter 2021 Financial Results and Announces New Strategic Direction to Develop Treatments for Immunological and Inflammatory Diseases Company announced license agreement with In4Derm Limited for BETi platform earlier this morning Company has initiated a process to explore a sale or license of its topical minocycline franchise Phase 2a results for FMX114 expected by year end and VYN201 and VYN202 to enter the clinic in 2022 Company has prepaid the entirety of its outstanding debt and expects to significantly reduce operating expenses Conference call and live webcast today at 8:30 am Eastern Time BRIDGEWATER , N.J. , August 12 , 2021 -- VYNE Therapeutics Inc. ( Nasdaq : VYNE ) ( “ VYNE " or the " Company " ) today announced financial results for the second quarter ended June 30 , 2021. The Company also announced that following an evaluation of its commercial and research and development assets , it has determined to transition its focus and resources to developing treatments for immuno - inflammatory diseases of high unmet medical need and has initiated a process to explore a sale or license of its topical minocycline franchise . Strategic Process to Sell or License Topical Minocycline Franchise VYNE conducted a review of its commercial and research and development portfolio of assets to determine how to optimally deploy capital and maximize shareholder value . Following this review , the Company has determined to initiate a process to explore a sale or license of its topical minocycline franchise , including AMZEEQ , ZILXI and FCD105 ( the Company's Phase 3 proprietary novel topical combination foam formulation of minocycline and adapalene for the treatment of moderate - to - severe acne vulgaris ) , as well as the underlying Molecule Stabilizing Technology platform specific to this portfolio . As VYNE transitions its focus and spend toward developing its pipeline , the Company expects to immediately reduce certain of its operating expenses currently supporting its commercial operations , but intends to maintain its sales force into the fourth quarter of 2021 while it seeks a commercial partner . " We continue to face headwinds commercializing our products in this environment , " said David Domzalski , CEO of VYNE . " We have been evaluating our portfolio of assets for some time in order to determine how to optimally deploy capital and drive shareholder value . After careful consideration , we have made the strategic decision to initiate a process to sell or license our topical minocycline franchise . We continue to believe that these products have significant commercial value , but their full potential is more likely to be realized in the hands of a partner with additional scale and resources . Going forward , we will focus our efforts on our pipeline of novel drug candidates . " Focus on Immunological and Inflammatory Conditions As announced in a separate press release earlier today , VYNE entered into an exclusive evaluation and option agreement with In4Derm Limited ( " In4Derm " ) , a spin - out of the University of Dundee's School of Life Sciences , focused on the discovery and development of proprietary Bromodomain and Extra - Terminal Domain inhibitors ( BETi ) for the treatment of immunology and oncology conditions . This partnership provides VYNE exclusive access to a library of small molecule NCES and a unique platform to develop both topical and oral BETi therapeutics for any condition worldwide . Topical BETi program : On August 6 , 2021 , VYNE exercised its option to develop topical BET inhibitors . VYN201 is a first - in - class topical pan - BD BET inhibitor that is designed to mitigate systemic drug exposure and will be developed for topical applications . VYNE intends to progress VYN201 in rare , neutrophilic , dermatological indications where there is significant unmet need due to a lack of indicated treatment options . This program is expected to enter the clinic in 2022 . 1