VYNE Therapeutics Inc.

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Our activities to evaluate and pursue potential strategic alternatives may not result in any transaction or enhance stockholder value.

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We have begun evaluating and exploring a variety of strategic alternatives focused on enhancing stockholder value, including the assessment of our internal pipeline, financing opportunities and strategic alternatives. These alternatives may include strategic partnerships, licensing opportunities, merger or acquisition transactions, asset sales or other potential paths. Although we are exploring strategic alternatives, our ability to successfully execute on a strategic alternative is dependent on a number of factors and we may not be able to execute upon a transaction or other strategic alternative upon favorable terms within an advantageous timeframe and recognize significant value for our assets, if at all. Additionally, the negotiation and consummation of a transaction or other strategic alternative may be costly and time-consuming. Any executed strategic alternative may not maximize or even enhance stockholder value, could result in total costs and expenses that are greater than expected, could make it more difficult to attract and retain qualified personnel and may disrupt our operations, each of which could have a material adverse effect on our business. In addition, a potential strategic alternative may require stockholder approval and stockholder approval may not be obtained and we may not successfully consummate the strategic alternative.

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In addition, the market price of our common stock may reflect a market assumption that a strategic alternative will occur, and a failure to complete a strategic alternative could result in negative investor perceptions and could cause a decline in the market price of our common stock, which could adversely affect our ability to access the equity and financial markets, as well as our ability to explore and enter into different strategic alternatives.

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If we do not successfully consummate a strategic alternative, our board of directors may decide to pursue a dissolution and liquidation of our company. In such an event, the amount of cash available for distribution to our stockholders will depend heavily on the timing of such dissolution and liquidation, and the amount of cash that will need to be reserved for commitments and contingent liabilities. Depending on these factors, the amount available for distribution to our common stockholders could be as low as zero and result in a total loss of investment to our stockholders.

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Drug development is very expensive, time-consuming and uncertain. Our preclinical studies and clinical trials may fail to adequately demonstrate the safety and efficacy of our current or any future product candidates, or serious adverse side effects could be identified. Any of these outcomes could prevent or delay regulatory approval and commercialization or harm our ability to pursue strategic alternatives for our product candidates.

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Drug development is very expensive, time-consuming and difficult to design and implement, and its outcome is inherently uncertain, particularly as it relates to new chemical entities. Before obtaining regulatory approval for the commercial sale of a product candidate, we must demonstrate through preclinical studies and clinical trials that a product candidate is both safe and effective for use in the target indication. Most product candidates that commence clinical trials are never approved by regulatory authorities for commercialization. The clinical trials for these product candidates may take significantly longer than expected to complete. In addition, we, any partner with which we may in the future collaborate, the FDA, an IRB or other regulatory authorities, including state and local agencies and counterpart agencies in foreign countries, may prevent, suspend, delay, require modifications to or terminate our clinical trials at any time, for various reasons, including:

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•lack of effectiveness of any product candidate during clinical trials or the failure of a product candidate to meet specified endpoints;

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•discovery of serious or unexpected side effects experienced by trial participants, toxicities or other safety issues;

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•slower than expected rates of subject recruitment and patient enrollment in clinical trials resulting from numerous factors, including the prevalence of clinical trials for our competitors for their product candidates treating the same indication;

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•difficulty in retaining subjects who have initiated participation in a clinical trial but may withdraw at any time due to adverse side effects from the therapy, insufficient efficacy, fatigue with the clinical trial process or for any other reason;

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•difficulty in obtaining IRB approval for studies to be conducted at each site;

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•delays in manufacturing or obtaining, or inability to manufacture or obtain, sufficient quantities of materials for use in clinical trials;

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•inadequacy of or changes in our manufacturing process or the product formulation or method of delivery;

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•changes in applicable laws, regulations and regulatory policies;

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•delays or failure in reaching agreement on acceptable terms in clinical trial contracts or protocols with prospective CROs, clinical trial sites and other third-party contractors;

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•inability to add a sufficient number of clinical trial sites;

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•uncertainty regarding proper dosing;

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•failure of our CROs or other third-party contractors to comply with contractual and regulatory requirements or to perform their services in a timely or acceptable manner;

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•failure by us, our employees, our CROs or their employees or any partner with which we may collaborate or their employees to comply with applicable FDA or other regulatory requirements relating to the conduct of clinical trials or the handling, storage, security and recordkeeping for drug and biologic products;

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•scheduling conflicts with participating clinicians and clinical institutions;

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•failure to design appropriate clinical trial protocols;

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•difficulty in maintaining contact with subjects during or after treatment, which may result in incomplete data; and

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•insufficient data to support regulatory approval.

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If we experience delays in the completion of, or if we terminate, any of our future clinical trials, our business, financial condition, operating results and prospects would be adversely affected. In addition, product candidates that initially showed promise in early stage testing may later be found to be not effective or cause side effects that prevent further development of the product candidate. For example, on July 30, 2025, we announced that our Phase 2b trial of repibresib gel in nonsegmental vitiligo did not achieve primary endpoint or key secondary endpoint of F-VASI50 and F-VASI75. We also announced in August 2025 that we decided to discontinue treatment in the ongoing extension phase of the trial and will terminate the trial.

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If our product candidates are associated with side effects in preclinical studies and/or clinical trials or have characteristics that are unexpected, a number of potentially significant negative consequences could result, including:

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•our development costs could increase;

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•we may need to abandon development activities or limit development to more narrow uses in which the side effects or other characteristics are less prevalent, less severe or more acceptable from a risk-benefit perspective;

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•we may need to abandon the development or limit the further development of our product candidates, including in various populations and for certain indications;

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•our reputation may suffer;

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•regulatory authorities may require that we suspend, discontinue, or limit our clinical trials based on safety information;

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•regulatory authorities may withdraw approval to market such product;

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•regulatory authorities may require additional warnings on the product labeling;

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•market acceptance of any products that do obtain regulatory approval could be inhibited.

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Any of these events could prevent us from pursuing strategic alternatives, including identifying and consummating transactions with third-party partners, to further develop, obtain marketing approval for and/or commercialize our product candidates and could significantly harm our business, results of operations and prospects.

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We may encounter delays in enrolling patients and successfully completing clinical trials for our product candidates and may be delayed in, or prevented from, commencing or completing such trials due to factors that are largely beyond our control.

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We have in the past experienced and may in the future experience delays in completing clinical trials and in commencing future clinical trials. Clinical trials can be delayed or terminated for a variety of reasons, including delay or failure to:

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•obtain regulatory approval to commence a trial;

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•reach agreement on acceptable terms with prospective contract research organizations ("CROs") and clinical trial sites, the terms of which may be subject to extensive negotiation and vary significantly among different CROs and trial sites;

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•obtain approval from an institutional review board (“IRB”) at each site;

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•enlist an adequate number of suitable patients to participate in a trial;