VYNE Therapeutics Inc Aktie

Good morning, and welcome to the VYNE Therapeutics conference call to discuss the merger of VYNE and Yarrow Bioscience. This call is being recorded for replay at the company's request.

It's now my pleasure to turn the call over to John Fraunces, Director, Corporate Communications for LifeSci Advisors. Please go ahead, John.

Good morning, and thank you for joining us for today's conference call. The link to this webcast is on the Investors page of the VYNE Therapeutics corporate website.

Before we begin, I would like to remind you that our call today will include remarks about future expectations, plans and prospects for VYNE and Yarrow, which constitute forward-looking statements for the purpose of the safe harbor provisions under applicable federal securities laws. These forward-looking statements include, without limitation, statements regarding the proposed merger and other contemplated transactions. These forward-looking statements involve significant risks and uncertainties that could cause actual results to differ materially from those expected, including those listed at the bottom of the press release that was released this morning.

Please note, as outlined on the press release that you're advised to read when available, VYNE's filings with the SEC include a registration statement that will contain a proxy statement and a prospectus because these documents will contain important information about the transaction and the participants' interest in such transaction. These documents can be obtained without charge at the SEC's Internet website, www.sec.gov.

I'll now turn the conference over to Dave Domzalski, President and Chief Executive Officer of VYNE.

Thank you, John. As we announced in our press release this morning, VYNE and Yarrow Bioscience have entered into a merger agreement pursuant to which the companies will combine in an all-stock transaction.

Yarrow Bioscience is a privately held clinical stage company founded by RTW Investments and focused on bringing a potentially first-in-class thyroid stimulating hormone receptor, or TSHR antibody to market for the treatment of Graves' disease and thyroid eye disease, commonly referred to as TED.

Joining me on today's call is Dr. Rebecca Frey, Chief Executive Officer of Yarr , who is expected to become the Chief Executive Officer of the combined company following the closing of the transaction.

I'll begin today's call by reviewing the details of our proposed merger with Yarrow and the pre-closing private placements in Yarrow by leading biotech investors to support the Yarrow programs moving forward. Following these remarks, Rebecca will provide an overview of Yarrow, its strategy and pipeline. Over the last several months, VYNE has undertaken a comprehensive strategic review to evaluate a wide range of options for maximizing stockholder value, including the assessment of our internal pipeline, financing opportunities and strategic alternatives.

After carefully reviewing all of our strategic options with our Board and our advisers, we believe this transaction with Yarrow offers VYNE stockholders a compelling opportunity for both short- and long-term value creation through a cash dividend to VYNE's premerger stockholders, as I'll describe below, and continued ownership in the combined company, which will focus on Yarrow's lead asset, YB-101 for the treatment of Graves' disease and TED.

Upon the closing of the transaction, the combined company's cash position is expected to provide cash runway into 2028, which is anticipated to be sufficient to advance Yarrow's lead asset, YB-101, through key inflection points. This cash position includes total proceeds of $200 million from pre-closing private placements of Yarrow common stock and common stock equivalents to a syndicate of best-in-class health care specialist investors.

This syndicate was led by RTW Investments and OrbiMed Advisors with participation from Janus Henderson, venBio Partners, Logos Capital, LifeSci Venture Partners and Perceptive Advisors. With this capital and support from world-class investors, we are confident the combined company is well equipped to execute its strategy through significant value-driving clinical catalysts.

Under the terms of the merger agreement, the premerger VYNE stockholders are expected to own approximately 3% of the combined company. Additionally, VYNE also expects to pay a cash dividend to premerger VYNE stockholders of approximately $14.5 million to $16.5 million immediately prior to the closing of the merger. Premerger Yarrow stockholders, inclusive of those investors participating in the Yarrow pre-closing financings are expected to own approximately 97% of the combined company.

Following the close of the proposed transaction, the combined company is expected to operate under the name Yarrow Bioscience, Inc. and to begin trading on NASDAQ under the ticker symbol YARW. We expect the merger transaction to close in the second quarter of next year.

We at Vine have been impressed with Yarrow's outstanding medical science and the quality of its leadership and have confidence in their ability to deliver on their strategy going forward. As shared, our decision to enter into this agreement with Yarrow follows a thorough strategic review, and we believe that this transaction positions our stockholders to realize value both in the short term and in the years ahead. On behalf of the VYNE management team, I would like to thank the Board members from each company for unanimously approving this transaction, which is subject to stockholder approval and customary closing conditions.

And with that, I'm pleased to introduce Dr. Rebecca Frey, Chief Executive Officer of Yaro Bioscience.

Thank you, Dave, for the introduction. On behalf of Yarrow, I want to thank you and the entire VYNE team for your partnership as we embark on this exciting transaction.

Today, we are thrilled to introduce Yarrow Bioscience and announce our planned merger with VYNE Therapeutics. At Yarrow, we are driven to develop safe and effective therapies to address unmet needs in thyroid autoimmune diseases, which produce serious, chronic and debilitating clinical sequelae. To that end, we are building a deeply experienced team of global drug developers and have in-licensed an asset with transformative clinical potential.

Our company is focused on bringing a clinical stage, potentially first-in-class TSHR antibody therapeutic to market for the treatment of both Graves' disease and thyroid eye disease or TED. Graves' disease and TED represent areas of significant unmet need for targeted therapeutics, particularly in patients who are inadequately treated with first-line therapies.

We recently in-licensed YB-101, also known as GS-098, a humanized monoclonal antibody targeting TSHR from Changchun GeneScience Pharmaceutical Company Limited, or GenSci. GenSci is currently developing YB-101 for the treatment of Graves' disease and TED in China. Through this collaboration, Yarrow has obtained global ex-China rights to develop YB-101 for both indications. YB-101 is a selective antibody to TSHR that has demonstrated promising efficacy results in preclinical models of Graves' disease and TED. This investigational product candidate is administered in a convenient subcutaneous injection and possesses a long half-life.

YB-101 is currently being evaluated in an ongoing Phase I clinical trial in TED by our partner, GenSci in China. Data from the single ascending dose portion of this trial in TED patients is expected in the first half of 2026. In parallel with GenSci's Phase I TED trial, Yarrow intends to initiate a combined Phase Ib/IIb trial of YB-101 in patients with Graves' disease in the United States and other territories in the first half of 2026.

Graves' disease is a common endocrine disease affecting an estimated 1% of the United States population. Among patients with Graves, an estimated 30% to 50% will also go on to develop TED. The current mainstay of treatment is antithyroid drugs or ATDs, which inhibit thyroid hormone synthesis.

However, ATDs are associated with dose-limiting toxicities, including hepatitis and agranulocytosis and not all patients achieve adequate disease control on ATDs. In Graves' disease, studies have shown that after 1 year, 25% or more of patients who receive first-line treatment with ATDs remain inadequately controlled and that even more patients may be refractory after 2 years.

When patients with Graves' disease cannot be adequately controlled with ATDs, their only options are tissue ablative interventions such as radioactive iodine or surgery to remove the thyroid, which both have significant safety risks. Similarly, in TED, patients are initially treated with glucocorticoids. If adequate response is not achieved, they may be treated with teprotumumab, an antibody targeting the IGF-1 receptor.

Teprotumumab is effective at improving the signs and symptoms of TED. However, it is associated with dose-limiting toxicities, including hearing impairment and hyperglycemia. It also does not directly inhibit the activity of autoantibodies at the TSH receptor. Currently, there are no approved therapies that can treat both Graves' hyperthyroidism and TED. And we believe that an easy-to-administer TSHR antibody with a favorable risk-benefit profile could become the preferred treatment for patients who are not adequately controlled on first-line therapies.

TSHR blockade directly addresses the main driver of both diseases. Both Graves disease and TED are polyclonal diseases in which autoantibodies attack and overstimulate the TSH receptor in the thyroid gland or in the eye. This overstimulation leads to hyperthyroidism and in TED oridopathy. Based on this well-characterized disease biology, TSHR is a rational target to treat both diseases because it is the final effector site regardless of autoantibody type or titer.

Recent publications of clinical trials evaluating this approach have shown that competitively blocking TSHR with a therapeutic antibody can rapidly reverse hyperthyroidism and improve signs and symptoms in patients with Graves' disease and TED. The differentiated target product profile of our TSHR antibody is a convenient subcutaneous therapy that we believe will deliver rapid and efficient reversal of hyperthyroidism along with meaningful improvement of extrahyroidal symptoms.

These effects are expected to be sustained over 4-week or longer dosing intervals, and it is expected that this benefit can be achieved with a favorable risk-benefit profile. This approach may offer a potentially rapid-acting, highly beneficial and convenient treatment option for patients with Graves' disease and TED. It represents a potential breakthrough for patients who are not adequately controlled with first-line therapies.

We believe this approach has a strong value proposition and that the addressable market across both indications represents a substantial global commercial opportunity. In conclusion, we are excited to advance YB-101 globally through our partnership with GenSci and through the planned merger with VYNE. In support of our bold vision for YB-101, we are delighted to welcome an industry-leading investor syndicate to fund our clinical progress in both indications. We look forward to working together with the VYNE team in the months ahead to prepare for the successful completion of this merger.

With that, I will conclude my remarks and hand the call back to the operator. Thank you for joining the call.

Ladies and gentlemen, this concludes today's event. You may disconnect your lines or log off the webcast at this time, and enjoy the rest of your day.