Yarrow Bioscience Announces Closing of Merger with VYNE Therapeutics and Initiation of Dosing in Phase 2a/2b Trial of YB-101, a Potential First-in-Class Treatment for Graves’ Disease and Thyroid Eye Disease
Yarrow is advancing YB-101—a potential first-in-class anti-TSHR antibody, designed to directly disrupt the central mechanism driving both Graves’ disease (“GD”) and thyroid eye disease (“TED”)
Dosing commenced in Phase 2a/2b GD trial following FDA Fast Track Designation, with Phase 2a data expected in 2H 2027
Data from ongoing Phase 1 multiple ascending dose (“MAD”) trial in patients with TED, conducted by partner, GenSci, in
Previously announced private financings totaling
Shares of combined company common stock to trade on Nasdaq under ticker symbol “YARW”
Yarrow’s lead product candidate, YB-101, is a potential first-in-class anti-thyroid stimulating hormone receptor (“TSHR”) monoclonal antibody designed to directly disrupt the central mechanism of both GD and TED, offering a single targeted treatment to address both diseases. By blocking TSHR, the common target of autoantibodies in both the thyroid and the eye, YB-101 has the potential to rapidly arrest the disease process and provide improved efficacy and safety versus the current standard of care and other mechanisms in development. YB-101 is designed for convenient subcutaneous administration, with the potential for infrequent dosing and future autoinjector presentation. The Company has initiated dosing in a Phase 2a/2b trial evaluating YB-101 in patients with GD, with or without concurrent TED, and the molecule has received Fast Track Designation from the
The Company’s licensing partner,
“Yarrow is emerging with multiple value drivers anchored by YB-101, our potentially first-in-class anti-TSHR antibody, and the opportunity to address two significant market opportunities in GD and TED with a single product candidate,” said
“With multiple clinical catalysts and cash runway into 2028, we believe Yarrow is well positioned to advance YB-101 and establish itself as a leader in thyroid autoimmune disease,”
Leadership Team
Yarrow's leadership team and Board combine extensive experience developing innovative medicines, leading biotechnology companies and guiding disciplined capital allocation. Together, they are focused on advancing YB-101 and creating long-term value for patients and stockholders.
Executive Leadership
Board of Directors
Mona Ashiya, PhD,
Transaction Financial Information
As previously announced, Yarrow successfully completed pre-closing private placements that resulted in total gross proceeds of approximately
Pursuant to the terms of the previously disclosed merger agreement, each outstanding share of Yarrow common stock was converted into 0.7171 shares of common stock of the combined company, as adjusted for the reverse stock split of VYNE common stock at a ratio of 1-for-50 shares, effected on
In addition, on
Following the completion of the reverse stock split and merger, the combined company’s total issued and outstanding common stock is approximately 2.8 million shares, or approximately 33.6 million shares on a fully-diluted basis, or approximately 28.6 million shares excluding shares underlying equity plans and awards.
About the Phase 2a/2b Clinical Trial of YB-101 in Patients with GD, with or without TED
The Phase 2a/2b clinical trial (NCT07682896) is a randomized, blinded, placebo-controlled two-part trial evaluating YB-101 in patients with GD, with or without concurrent TED. The Phase 2a (Part 1) is a proof-of-concept trial of YB-101 versus placebo aiming to enroll 32 patients across four cohorts. The trial will evaluate safety, pharmacokinetics (“PK”), pharmacodynamics (“PD”), and efficacy endpoints through 24 weeks, including the percentage of patients that are euthyroid and off of anti-thyroid drugs, as well as relevant measures of orbitopathy in patients with concurrent TED. Data from the Phase 2a portion are expected in 2H 2027.
Part 2 is expected to be conducted as a Phase 2b dose-finding trial and enroll approximately 200 patients. The selection of doses and dosing intervals for Part 2 is expected to be informed by the safety, efficacy, PK, and PD data generated in Part 1 (Phase 2a). The Phase 2b is anticipated to commence in 1H 2028.
About Yarrow Bioscience
Yarrow Bioscience, Inc. is a clinical-stage biotechnology company focused on developing transformative therapies for autoimmune thyroid diseases. The Company is developing YB-101, a potentially first-in-class anti-thyroid stimulating hormone receptor (“TSHR”) monoclonal antibody designed to directly and rapidly disrupt the central mechanism of both GD and TED. For more information, visit www.yarrowbioscience.com.
Forward-looking Statements
This communication contains forward-looking statements (including within the meaning of Section 21E of the Exchange Act and Section 27A of the Securities Act) concerning the Company. These forward-looking statements include express or implied statements relating to: the anticipated benefits of the Merger and the previously announced private financings, including with respect to the combined company’s future financial and operating results; the expected listing and trading of the combined company’s common stock on the Nasdaq Capital Market under the ticker symbol “YARW”; the therapeutic potential of YB-101 to address both GD and TED with a single product candidate; the design, initiation, enrollment, progress, timing and results of clinical trials of YB-101 conducted by the Company and by GenSci, including the expected timing of data from the Phase 2a portion of the Company’s Phase 2a/2b trial, data from the MAD portion of GenSci’s Phase 1 TED trial, and the anticipated commencement of the Phase 2b portion of the trial; the Company’s regulatory strategy and its ability to obtain and maintain regulatory approvals, including the implications of YB-101’s Fast Track Designation; the sufficiency of the combined company’s capital resources and its expectation that its cash balance will fund operations into 2028; the Company’s licensing partnership with GenSci and future development plans for YB-101 in TED globally; the market opportunity for YB-101 in GD and TED; and the Company’s strategy, plans, objectives and expectations for future operations. The words “anticipate,” “believe,” “contemplate,” “continue,” “could,” “estimate,” “expect,” “intend,” “may,” “might,” “plan,” “possible,” “potential,” “predict,” “project,” “should,” “will,” “would” and similar expressions (including the negatives of these terms or variations of them) may identify forward-looking statements, but the absence of these words does not mean that a statement is not forward-looking. These forward-looking statements are based on current expectations and beliefs concerning future developments and their potential effects. There can be no assurance that future developments affecting the Company will be those that have been anticipated.
The forward-looking statements contained in this communication are based on current expectations and beliefs concerning future developments and their potential effects and therefore are subject to other risks and uncertainties. These risks and uncertainties include, but are not limited to, risks associated with the possible failure to realize certain anticipated benefits of the Merger, including with respect to future financial and operating results; the effect of the completion of the Merger on the combined company’s business relationships, operating results and business generally; risks associated with the combined company’s ability to manage expenses and unanticipated spending and costs that could reduce the combined company’s cash resources; risks related to the combined company’s ability to correctly estimate its operating expenses and other events; changes in capital resource requirements; risks related to the inability of the combined company to obtain sufficient additional capital to continue to advance its product candidates or its preclinical programs; the outcome of any legal proceedings that may be instituted against the combined company or any of its directors or officers related to the Merger Agreement or the transactions contemplated thereby; the ability of the combined company to obtain, maintain and protect its intellectual property rights, in particular those related to its product candidates; the combined company’s ability to advance the development of its product candidates or preclinical activities under the timelines it anticipates in planned and future clinical trials; the combined company’s ability to replicate in later clinical trials positive results found in preclinical studies and early-stage clinical trials of its product candidates; the combined company’s ability to realize the anticipated benefits of its research and development programs, strategic partnerships, licensing programs or other collaborations; regulatory requirements or developments and the combined company’s ability to obtain necessary approvals from the FDA or other regulatory authorities; changes to clinical trial designs and regulatory pathways; competitive responses to the Merger and changes in expected or existing competition; unexpected costs, charges or expenses resulting from the Merger; potential adverse reactions or changes to business relationships resulting from the completion of the Merger; legislative, regulatory, political and economic developments; and those risks and uncertainties and other factors more fully described in filings with the Securities and Exchange Commission (the “SEC”), including reports filed on Form 10-K, 10-Q and 8-K and in other filings made by the Company with the SEC from time to time and available at www.sec.gov. These forward-looking statements are based on current expectations, management’s beliefs and certain assumptions made by the Company, all of which are subject to change. Such forward-looking statements are made as of the date of this communication, and the parties undertake no obligation to update such statements to reflect subsequent events or circumstances, except as otherwise required by securities and other applicable law.
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For More Information
Investor Contact
Joyce Allaire
LifeSci Advisors
Jallaire@lifesciadvisors.com
Media Contact
Michael Galfetti
Ten Bridge Communications
tbcyarrow@tenbridgecommunications.com
Source: Yarrow Bioscience, Inc.