VYNE Therapeutics Announces Positive Preclinical Data For Inhaled Formulation Of VYN201 In An In Vivo Model Of Idiopathic Pulmonary Fibrosis

"Data from this well-validated preclinical model of IPF clearly demonstrate the potential of VYN201 to deliver a potent anti-inflammatory and antifibrotic response," said David Domzalsky, President and CEO of VYNE. "These IPF data support the potential utility of VYN201 as a topical therapy for a variety of immuno-inflammatory indications and further highlight the potential value of our InhiBET™ BET inhibitor platform."

Bleomycin-induced mouse model

IPF is a life-threatening chronic lung disease with several treatment options. Patients experience debilitating symptoms, including shortness of breath and difficulty performing daily activities. Current standard treatment options for IPF have been shown to have little effect in slowing disease progression and are associated with significant side effects.

In this well-established preclinical model of IPF, pulmonary fibrosis was induced in mice with a single dose of intratracheal bleomycin. Fibrosis was allowed to develop for seven days, and tomographic images of the breast were obtained to assess the development of fibrosis. Animals were divided into six treatment groups: untreated and unstimulated control, placebo, and one of four doses of VYN201 (0.1, 0.2, 0.5, and 1.0 mg/ml) (N=6/group). Each treatment group was administered intratracheally every other day for 14 days. Blood oxygen saturation, Ashcroft score (a standardized numerical scale used to determine the degree of pulmonary fibrosis in histological specimens), lung hydroxyproline (tissue biomarker for fibrosis) and function were assessed.

Key findings:

   -- Ashcroft scale and hydroxyproline level: VYN201 0.5 mg/ml and 1 
      mg/mL showed a statistically significant decrease in Ashcroft. 
      outcomes (measurement of pulmonary fibrosis) and levels of tissue fibrosis 
      biomarker, hydroxyproline, compared to daily placebo control 
      21 
 
          -- Mean control-adjusted pulmonary fibrosis scores were VYN201 1 mg/mL. 
             65.8% less than the placebo control group at day 21. 
 
   -- Blood oxygen saturation: VYN201 demonstrated a dose-dependent improvement 
      in blood oxygenation. 
 
          -- Blood oxygen saturation in the VYN201 1mg/ml group was average. 
             92.4% at day 21, an 8.8% improvement compared to the placebo group. 
             (83.6%). Raw email average blood oxygen saturation 
             the unstimulated control group was 95.2%. 
 
   -- Volumetric lung function: Chest CT revealed VYN201 
      treatment groups showed a dose-dependent improvement in function 
      lung volume compared to a placebo control group. This data is linked 
      with an increase in blood oxygen saturation and a decrease in Ashcroft 
      fibrosis results. 
 
          -- Treatment with VYN201 1mg/mL resulted in a mean improvement of 51.8%. 
             in functional lung volume compared to placebo-treated animals 
             careful

ABOUT VIN201

VYN201 is a pan-bromodomain BET inhibitor intended to be administered as a "soft" agent for the treatment of diseases involving multiple and diverse inflammatory cell signaling pathways while providing low systemic exposure. To date, VYN201 has produced a consistent reduction in pro-inflammatory and disease-related biomarkers and an improvement in disease severity, and has shown local activity in several preclinical models (using different routes of administration). The Company believes these data demonstrate the broad potential utility of VYN201 across a variety of routes of administration.

VYNE has completed a phase 1a study of the topical formulation of VYN201 in healthy volunteers and is currently evaluating the topical formulation in a phase 1b study in patients with non-segmental vitiligo. A phase 1a study showed that topical VYN201 worked as expected. Notably, VYN201 had minimal systemic exposure and did not have the common side effects associated with systemic administration of pan-BD BET inhibitors, such as thrombocytopenia. VYNE will report the best results from the phase 1b study in mid-2023.

About supply inhibitors

BET proteins play a key role in regulating gene transcription through epigenetic ("switching") interactions, and recent studies have identified a key role for these proteins in regulating B and T cell activation and subsequent inflammatory processes. As epigenetic readers, BET proteins regulate the recruitment of transcription factors critical for the production of various pro-inflammatory cytokines. BET inhibitors have the potential to treat a wide range of immuno-inflammatory and fibrotic diseases by blocking the transcription of inflammatory cytokines, with additional potential in myeloproliferative neoplastic diseases.

Learn more about VYNE Therapeutics Inc.

VYNE's mission is to improve patients' lives by developing patented, innovative and differentiated treatments for immuno-inflammatory diseases. The company's unique proprietary bromodomain and extraterminal (BET) platform includes lead programs, VYN201 (field-delivered pan-BD BETi) and VYN202 (selectively orally available BD2 BETi), as well as access to an inhibitor library for molecules small possible therapeutic BET . . Immunoinflammatory Diseases under license from Tay Therapeutics Limited.

For more information about VYNE Therapeutics Inc. or potential products, please visit www.vynetherapys.com. VYNE may use its website to comply with its disclosure obligations under Regulation FD. Therefore, investors should keep an eye on VYNE's website, as well as follow press releases, US Securities and Exchange Commission reports, public conference calls and webcasts.

Caution Regarding Forward-Looking Statements

This release contains forward-looking statements pursuant to the Securities and Exchange Reform Act of 1995, including, but not limited to, statements regarding the VYNE Betting Ban platform and statements about the hopes, plans and prospects of VYNE for the future. All statements in this press release that are not historical facts are forward-looking statements. Any forward-looking statements are based on VYNE's current knowledge and current beliefs and expectations about possible future events and are subject to risks, uncertainties and assumptions that could cause actual results to differ materially and adversely from those expressed or implied herein. statements for the sake of statements These risks and uncertainties include, but are not limited to: VYNE's ability to successfully develop product candidates; the timing of initiation of future preclinical studies and clinical trials; VYNE's ability to enroll patients and successfully conduct, complete and obtain positive results from clinical trials of its product candidates; VYNE's ability to exercise its exclusive option of an oral BET inhibitor candidate pursuant to an option agreement with Tay Therapeutics Limited; VYNE's intentions and ability to obtain additional financing, whether through equity or debt financing transactions or partnership arrangements; disruptions related to COVID-19 or other pandemics, epidemics or outbreaks of infectious diseases, the ability of VYNE suppliers to manufacture and supply materials for VYNE product candidates, initiation and retention of patients in clinical trials, operational results, liquidity and financial condition ; the regulatory approval process for VYNE product candidates, including delays or failure to obtain necessary approvals; the potential size of the market for drugs to treat each disease and the market consumption of the products, if licensed or licensed for commercial use, by physicians and patients; developments and forecasts regarding competitors and the pharmaceutical industry, including competing drugs and treatments; the timing or likelihood of submission and approval or authorization of product candidates to regulatory authorities; VYNE's ability to comply with various regulations applicable to its business, including current Nasdaq listing rules; VYNE's ability to establish the intellectual property and protection system it can establish and maintain for its intellectual property rights related to its product candidates, including anticipated patent protection requirements; there is a risk that any of VYNE's patents will be limited, invalid or unenforceable, or that one or more of VYNE's patent applications will not be granted, and that potential competitors may also attempt to circumvent granted patents from VYNE or design patent applications; The time, cost or outcome of litigation, including litigation to protect your intellectual property; VYNE's ability to successfully challenge others' intellectual property claims; Estimates of VYNE's expenses, capital requirements, additional financing needs and ability to raise additional capital on an acceptable basis.

conditions or not; VYNE's ability to attract and retain management or scientific staff; Defense against potential lawsuits against VYNE; VYNE's expectations regarding licensing, business operations and strategic operations; VYNE's future financial performance and liquidity; and volatility in VYNE's stock price could result in a rapid and significant increase or decrease in stock prices, whether related to the company's operating performance or outlook. For a discussion of other risks and uncertainties and other important factors, any of which could cause VYNE's actual results to differ materially from those contained in the forward-looking statements, please see the "Risk Factors" section at VYNE Formula 10 Annual Report. K For the year ended December 31, 2022 and the discussion of potential risks, uncertainties and other important factors in VYNE's subsequent filings with the US Securities and Exchange Commission. VYNE believes that these forward-looking statements are reasonable, speak only as of the date of this announcement, and VYNE does not undertake to publicly update 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 on any forward-looking statements as predictions of future events.

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