VYNE Therapeutics Inc.

Good morning, and welcome to the Vine Therapeutics conference call to discuss the third quarter 2021 financial results and corporate update. At this time, all participants are in a listen-only mode, and following the company's formal remarks, we will open the call for your questions. Please be advised that this call is being recorded at the company's request. I will now turn the call over to John Francis of LifeSci Advisors. Please go ahead.

Good morning, everyone, and thank you for joining us. Participating in this morning's call are Dave Domzalski, Vine's President and Chief Executive Officer, Tyler Zaranda, Vine's Chief Financial Officer, and Dr. Ian Stewart, the company's Chief Scientific Officer. Please note that there are slides to accompany Dr. Stewart's discussion. For those of you dialed into the phone lines, in order to access these slides, you will need to log on to the live webcast. The link can be found on the Investors and Media section of Vine's corporate website under Events and Presentation. Slide presentation and a replay of this conference call will be archived on the company's website. Before we begin formal remarks, let me remind you that some of the information in the press release issued this morning and on this conference call contain forward-looking statements that involve risks, uncertainties, and assumptions that are difficult to predict, including statements regarding Vine's development programs and future plans and prospects, as well as observations regarding ongoing operating expenses. These statements will include plans and expectations regarding strategic transactions, and the success, timing, and cost of clinical trials. Words that express and reflect optimism, satisfaction with current progress, prospects or projections, as well as words such as believe, intend, expect, plan, anticipate, and similar variations, identify forward-looking statements, but their absence does not mean that a statement is not forward-looking. Such forward-looking statements are not a guarantee of performance, and the company's actual results could differ materially from those contained in such statements. Several factors that could cause or contribute to such differences are described in detail in Vines Therapeutics filings with the SEC. These forward-looking statements speak only as of the date of today's press release and conference call, and the company undertakes no obligation to publicly update any forward-looking statements or supply new information regarding the circumstances after the date of this call. In addition, the financial portion of this call will include certain non-GAAP financial information. For additional disclosures relating to these non-GAAP financial measures, including a reconciliation to the most directly comparable gap measures, please see today's press release, which is posted on the investor relations section of our website. At this time, I would like to turn the call over to Dave Domzalski. Dave, please go ahead.

Thank you, John, and good morning to everyone. On our previous earnings call, we announced our transformational decision to refocus our efforts toward developing new and innovative therapies for the treatment of immunoinflammatory diseases. Today, one quarter later, I'm pleased to report that we've achieved a number of important milestones as we continue to advance our proprietary pipeline through a series of near-term, early-stage clinical catalysts over the next 12 to 18 months. Without question, the catalytic event driving this transformation has been the licensing of our bromodomain and extra-terminal, or BET, inhibitor platform, which we announced in August. As a reminder, the BET inhibitor platform provides Vine worldwide rights to a library of small molecule MCEs and a unique platform to develop both topical and oral BET inhibitor therapeutics for any indication. Because BET inhibitors have the ability to target multiple pro-inflammatory pathways, We believe this exciting new drug class could offer the opportunity for highly potent therapies. These therapies have the potential to address serious unmet medical needs with immunoinflammatory diseases. We are now poised to generate a series of exciting, data-driven milestones that we believe will unveil the significant therapeutic potential of these assets. Our focus will be to advance our lead topical bet inhibitor product candidate VYN201, into the clinic in 2022. VYN201 is a first-in-class pan-BD BET inhibitor that is designed to reduce inflammation while mitigating systemic drug exposure. VYN201 is being developed for topical applications, potentially including rare dermatoses where there is significant unmet need due to a lack of indicated treatment options. As many of you know, We recently announced positive data showing that BYN201 was able to significantly reduce several key pro-inflammatory cytokines in both a preclinical model and in a human skin tissue model. Additionally, BYN201 demonstrated improvements in reducing fibrotic tissue mass and overall skin repair outcomes with no negative impact on healing time. These findings offer valuable insights into the evolving therapeutic profile of BYN201, suggesting that the drug may offer optimized efficacy and safety characteristics that could be highly differentiated. Our Chief Scientific Officer, Dr. Ian Stewart, will review the details from these studies later in the call. In parallel with these efforts, we have been working diligently with our partner, InfraDerm, on the development of the oral BET inhibitor, BYN202. BYN202 is an orally delivered, first-in-class bet inhibitor that is highly selective for bromodomain 2, or BD2, with the goal of having a more targeted anti-inflammatory effect with an improved benefit-risk profile as compared to other oral, non-selective bet inhibitors. Upon final candidate selection, we intend to commence an IND-enabling non-clinical safety program and enter the clinic. We are evaluating BYN202 for use in several potential indications within initial focus on autoimmune conditions. To further support our BET inhibitor programs, we recently formed our Scientific Advisory Board, which will provide an important source of external scientific and medical expertise as we expand our BET inhibitor R&D activities. The members of our scientific advisory board are world-renowned experts specializing in immunological and inflammatory diseases, and we are incredibly fortunate to have these distinguished scientists and clinicians to help guide our BET inhibitor and other development programs. Turning to FMX114, we are encouraged by the progress we are making for our most advanced drug candidates. In October, we announced the first patient had enrolled in our Phase 1B, 2A clinical trial that will assess the safety and efficacy of FMX114 gel versus vehicle gel in patients with mild to moderate atopic dermatitis. In light of the FDA's recent review of the oral JAK inhibitor class for the treatment of several systemic autoimmune diseases, we believe it's important to characterize the preliminary safety and pharmacokinetic profile of FMX114. The Phase 1b portion of the study will generate meaningful data as we advance the product into the Phase 2a portion for broader safety and efficacy evaluation. We currently expect top-line results from this study in the early part of the first quarter of next year. As a reminder, FMX114 is a proprietary topical combination formulation of tocacidinib, a Janus Kyanus inhibitor. and Fingolimod, a sphingosine 1 phosphate receptor modulator that is being evaluated for the treatment of mild to moderate atopic dermatitis. This program is an important part of our strategic transition to develop therapies for immunoinflammatory conditions. Atopic dermatitis is a chronic, pruritic inflammatory skin condition and is a multifactorial disease which supports our thesis that a multimodal therapeutic is the ideal approach to achieve optimal clinical outcomes for patients. FMX114 has been designed with intracellular and extracellular mechanism of actions to address both the source and cause of inflammation in atopic dermatitis. As a JAK inhibitor, topacitinib reduces inflammation by inhibiting the release of cytokines that promote inflammation in the skin. These cytokines negatively impact both skin barrier integrity and function, which are key components of the disease. FMX114's second component, Fingolimod, reduces inflammation by inhibiting the migration of inflammatory cells into the skin. Additionally, Fingolimod upregulates filaggrin, a protein, which plays an important role in supporting skin barrier recovery. If successfully developed, We believe FMX114 has the potential to be the first topical combination product for the treatment of atopic dermatitis. Now, I'd like to briefly touch on the planned sale of our topical minocycline franchise, which includes Amzeek, Zilxy, SCD105, which is our phase three ready combination product, and the underlying MST platform. These are excellent products. and the responses from patients and healthcare providers continues to be very positive. Amzeek and Zilksie have generated nearly 165,000 prescriptions combined through September of this year. As noted in this morning's press release, our Minocyclone franchise is a high-quality commercial platform that has significant value. We continue to make progress on the sale of this franchise, and we are encouraged by the level of interest we have received. We will provide additional updates as our current discussions continue to advance. With that, I'd now like to turn the call over to Tyler to cover the financials. Tyler?