VYNE Pharmaceuticals Ltd.

VYN202 has been designed to achieve class-leading potency and BD2-selectivity Trial will evaluate safety, tolerability, pharmacokinetics and pharmacodynamics of VYN202 in healthy volunteers; top-line data expected in 2H’24 BRIDGEWATER, N.J., June 13, 2024 (GLOBE NEWSWIRE) -- VYNE Therapeutics Inc. (Nasdaq: VYNE) (“VYNE” or the “Company”), a clinical-stage biopharmaceutical company developing proprietary, innovative and differentiated therapies for the treatment of immuno-inflammatory conditions, today announced that the first healthy volunteers have been dosed in the Phase 1a trial of VYN202. VYN202 is an oral small molecule BD2-selective bromodomain and extra-terminal domain (BET) inhibitor that is being developed for the treatment of immuno-inflammatory diseases. Top-line data are expected in the second half of 2024. “We are pleased to announce the initiation of the first-in-human clinical trial of VYN202, a highly selective and potent orally administered BET inhibitor. In preclinical testing, VYN202 achieved consistent improvements in disease severity across a variety of inflammatory and fibrotic models as well as reductions in pro-inflammatory and disease-related biomarkers,” said David Domzalski, President and CEO of VYNE. “We believe VYN202 has significant potential as a treatment option for a broad range of immune-mediated diseases, and we look forward to reporting top-line data from the Phase 1a trial in the second half of this year.” The Phase 1a trial is a first-in-human double-blind, placebo-controlled study in healthy volunteers and consists of single ascending dose (SAD) and multiple ascending dose (MAD) components. The trial is currently expected to enroll approximately 64 healthy adult subjects into five SAD and three MAD cohorts to evaluate the safety, tolerability, pharmacokinetics and pharmacodynamics of VYN202. “Early generation BET inhibitors show similar affinity to both BD1 and BD2 bromodomains of BET proteins that has been implicated in both gastrointestinal and hematologic dose limiting toxicities,” said Dr. Iain Stuart, Chief Scientific Officer of VYNE. “We believe VYN202’s high potency and selectivity towards the BD2 bromodomain of BET proteins may result in an improved benefit-risk pro treating immuno-inflammatory diseases. Following highly encouraging preclinical data, we are eager to evaluate the clinical safety, tolerability, pharmacokinetics and pharmacodynamics of VYN202 to further inform our future clinical development plans.” About VYN202 VYN202 is an innovative, oral small molecule BD2-selective BET inhibitor that has been designed to achieve class-leading selectivity (BD2 vs. BD1), maximum potency versus BD2, and optimal oral bioavailability. By maximizing BD2 selectivity, VYNE believes VYN202 has the potential to be a more conveniently administered non-biologic treatment option for both acute control and chronic management of immuno-inflammatory indications, in which the damaging effects of unrestricted inflammatory signaling activity is common. VYN202 is structurally distinct from VYNE’s pan-BET inhibitor (VYN201) and covered by distinct PCT and provisional composition of matter patent applications directed to new chemical entities and their uses. About BET Inhibitors BET proteins play a key role in regulating gene transcription via epigenetic interactions (“reading”), and recent research has identified a key role for these 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 several pro-inflammatory cytokines. BET inhibitors have the potential to treat a range of immuno-inflammatory and fibrotic diseases by blocking pro-inflammatory cytokine transcription with additional potential in myeloproliferative neoplastic disorders. 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. The Company’s unique and proprietary bromodomain & extra-terminal (BET) domain inhibitors, which comprise its InhiBET™ platform, include a locally administered pan-BD BET inhibitor (VYN201) and an orally available BD2-selective BET inhibitor (VYN202) that were licensed from Tay Therapeutics Limited. For more information about VYNE Therapeutics Inc. or its product candidates, visit . 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 (“SEC”), public conference calls, and webcasts. 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 related to the potential benefits of VYN202 as a therapy for a broad range of immune-mediated diseases and the expected timing for reporting top-line results from the Phase 1a trial in the second half of 2024. 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 enroll patients in its clinical trials and successfully develop its product candidates; VYNE’s ability to complete and receive favorable results from, clinical trials of its product candidates; VYNE’s ability to obtain additional funding, either through equity or debt financing transactions or collaboration arrangements; and VYNE’s ability to comply with various regulations applicable to its business. 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, 2023 and VYNE’s other filings from time to time with the SEC. 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. Investor Relations: John Fraunces LifeSci Advisors, LLC 917-355-2395 jfraunces@lifesciadvisors.com Tyler Zeronda VYNE Therapeutics Inc. 908-458-9106 Tyler.Zeronda@vynetx.com Media Relations: Mike Beyer Sam Brown Inc. 312-961-2502 mikebeyer@sambrown.com

Trial will evaluate once-daily VYN201 gel in subjects with either active or stable nonsegmental vitiligo Top-line data from the 24-week double-blind portion of the trial expected in mid-2025 BRIDGEWATER, N.J., June 05, 2024 (GLOBE NEWSWIRE) -- VYNE Therapeutics Inc. (Nasdaq: VYNE) (“VYNE” or the “Company”), a clinical-stage biopharmaceutical company developing proprietary, innovative and differentiated therapies for the treatment of immuno-inflammatory conditions, today announced that the first subject has been dosed in a Phase 2b trial evaluating VYN201 in subjects with either active or stable nonsegmental vitiligo. VYN201 is a novel pan-bromodomain and extra-terminal domain (BET) inhibitor designed for local administration. Top-line data from the 24-week vehicle-controlled treatment period are expected in mid-2025. The randomized, double-blind, vehicle-controlled trial will evaluate the safety and efficacy of once-daily VYN201 topical gel in three dose cohorts (1%, 2% and 3% concentrations) compared to vehicle for 24 weeks. A total of approximately 160 subjects will be randomized at a 1:1:1:1 ratio. Following the 24-week treatment period, subjects in the active treatment arms will continue for an additional 28 weeks, and subjects in the vehicle group will be equally re-randomized to receive VYN201 1%, 2% or 3% gel for an additional 28 weeks. The primary efficacy endpoint of the trial is the proportion of subjects achieving an improvement in Facial Vitiligo Area Scoring Index of at least 50% from baseline (F-VASI50) at week 24 compared to vehicle, with additional secondary endpoints of F-VASI and Total VASI (T-VASI) at weeks 24 and 52. “Dosing the first subject in the Phase 2b trial for vitiligo is an important milestone for the VYN201 program and our Company,” said David Domzalski, President and CEO of VYNE. “In our prior Phase 1b trial, VYN201 demonstrated a significant clinical response with a rapid onset of action and a favorable safety and tolerability profile, including low systemic exposure. We believe that VYN201 has the potential to become a valuable and differentiated therapy for patients with vitiligo. We look forward to reporting top-line data from the 24-week treatment period in mid-2025.” About Vitiligo Vitiligo is a chronic autoimmune depigmenting disorder of the skin, characterized by the loss of pigment producing cells known as melanocytes. Vitiligo is the most common depigmenting skin condition, with a prevalence estimated at 0.5-2.0% of the world population. There is currently only one FDA-approved product for the treatment of vitiligo. Nonsegmental vitiligo is the most common type of vitiligo. About VYN201 VYN201 is a pan-bromodomain BET inhibitor designed to be locally administered as a “soft” drug to address diseases involving multiple, diverse inflammatory cell signaling pathways, while providing low systemic exposure. In addition to demonstrating clinical proof-of-concept in vitiligo, VYN201 has produced consistent reductions in pro-inflammatory and disease-related biomarkers and improvements in disease severity in several preclinical models (using several different routes of administration). About BET Inhibitors BET proteins play a key role in regulating gene transcription via epigenetic interactions (“reading”), and recent research has identified a key role for these 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 several pro-inflammatory cytokines. BET inhibitors have the potential to treat a range of immuno-inflammatory and fibrotic diseases by blocking pro-inflammatory cytokine transcription with additional potential in myeloproliferative neoplastic disorders. 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. The Company’s unique and proprietary bromodomain & extra-terminal (BET) domain inhibitors, which comprise its InhiBET™ platform, include a locally administered pan-BD BET inhibitor (VYN201) and an orally available BD2-selective BET inhibitor (VYN202) that were licensed from Tay Therapeutics Limited. For more information about VYNE Therapeutics Inc. or its product candidates, visit . 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 (“SEC”), public conference calls, and webcasts. 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 related to the potential benefits of VYN201 as a therapy for nonsegmental vitiligo and the expected timing for receipt of top-line results from the Phase 2b trial in mid-2025. 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 successfully enroll subjects in its clinical trials and develop its product candidates; VYNE’s ability to complete and receive favorable results from, clinical trials of its product candidates; VYNE’s ability to obtain additional funding, either through equity or debt financing transactions or collaboration arrangements; and VYNE’s ability to comply with various regulations applicable to its business. 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, 2023 and VYNE’s other filings from time to time with the SEC. 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. Investor Relations: John Fraunces LifeSci Advisors, LLC 917-355-2395 jfraunces@lifesciadvisors.com Tyler Zeronda VYNE Therapeutics Inc. 908-458-9106 Tyler.Zeronda@vynetx.com Media Relations: Mike Beyer Sam Brown Inc. 312-961-2502 mikebeyer@sambrown.com

LOS ANGELES--( BUSINESS WIRE )-- Pearl , the global leader in dental AI solutions, is carrying significant momentum into the new year following massive expansion and key successes in 2023, including key patent additions, new global market expansions, major industry partnerships, numerous technology awards, leadership additions and revenue growth exceeding 500%. “Last year, Pearl made tremendous progress toward our goal of transforming dentistry and the dental health of patients around the world with AI,” said Ophir Tanz, founder and CEO of Pearl. “We will accelerate that progress and drive even greater innovation in 2024, thanks not only to our relentless innovation of best-in-class dental AI solutions for the global dental market, but also to committed partnerships with technology and institutional leaders who share our AI-powered vision for the future of dentistry.” Pearl’s most notable 2023 milestones include: New Patents : Pearl cemented the innovation at the core of its technology with a new industry patent for its chairside AI disease detection software , the second patent for its breakthrough Second Opinion® technology. The patent grants Pearl the exclusive rights to the technology system supporting the software’s application programming interface (API). Pearl was also issued a patent granting exclusive rights to the computer vision and analytics system at the core of its pioneering clinical performance software, Practice Intelligence® , bringing the company’s total number of U.S. patents to 12. Global Expansion: Pearl further solidified its position at the forefront of the dental AI revolution with numerous additional global regulatory authorizations in 2023, including clearances in Israel , Turkey , Saudi Arabia, Chile, Argentina and Switzerland. Second Opinion® also became the first-and-only AI-based dental pathology detection software to gain Class IIa medical device certification under the updated European Union Medical Device Regulation (EU-MDR), one of the world's most robust health tech regulations. At the 2023 International Dental Show in Cologne, Germany, Pearl announced plans to expand access to its Practice Intelligence® solution for the European market. Strategic Partnerships: Throughout 2023, Pearl announced over a dozen new partnerships, including many that bring Pearl’s clinical AI capabilities to dentistry’s leading software platforms from Patterson Dental , Planmeca , Planet DDS , CareStack , Curve , Oryx , Dentulu , VisiQuick and Vyne Dental . Awards and Recognition: Pearl took home three prestigious industry awards recognizing the company’s commitment to technological excellence in both the U.S. and UK dental markets, including a 2023 Cellerant Best of Class Technology Award for the second consecutive year, two UK Dental Industry Awards for “High Technology Launch of the Year” and “New Product/Service of the Year,” and a Nifty Award for “Favorite Dental AI Company.” To continue driving the company’s mission, Pearl also announced the expansion of its leadership team in November 2023 with the appointment of Ben Plomion as Chief Operating Officer and Mike Barniv, DDS as Vice President of Clinical Affairs. About Pearl Pearl is leading the global dental AI revolution with groundbreaking computer vision solutions that elevate efficiency, accuracy, and the standard of care in dentistry. Founded in 2019 by Ophir Tanz, Pearl is backed by Craft Ventures and other leading venture capital firms. To request a demo, please visit hellopearl.com/demo .