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VYNE THERAPEUTICS INC.

(VYNE)
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VYNE Therapeutics Announces its China Partner’s Enrollment of First Patient in Phase 3 Study of AMZEEQ® in Patients with Moderate to Severe Acne

10/05/2021 | 08:00am EST

VYNE Therapeutics Inc. announced that the first patient has been enrolled in a Phase 3 study in China evaluating AMZEEQ® (minocycline) topical foam, 4% in moderate to severe acne. The study is being conducted by the Company’s partner, Cutia Therapeutics (“Cutia”), for the purposes of seeking regulatory approval for AMZEEQ in China. The study is a multicenter, randomized, double-blind, vehicle-controlled Phase III study to evaluate the efficacy and safety of topical administration of minocycline topical foam, 4% in the treatment of moderate-to-severe acne vulgaris. It is expected to enroll 372 patients at approximately 29 sites in China. The primary endpoint for the study is the absolute change from baseline in inflammatory lesion count at Week 12, while a key secondary endpoint is IGA endpoint success at Week 12, where success is defined as an IGA score of 0 or 1 (clear or almost clear), and at least a 2-grade improvement (decrease) from baseline. In April 2020, VYNE entered into a licensing agreement with an affiliate of Cutia Therapeutics, a dermatology-focused company based in Shanghai, China. Under the terms of the agreement, Cutia has an exclusive license to obtain regulatory approval of and commercialize AMZEEQ, ZILXI and its FCD105 product candidate, once approved, in greater China. The Company is eligible to receive royalties on net sales of any licensed products.


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Financials (USD)
Sales 2021 16,7 M - -
Net income 2021 -68,1 M - -
Net Debt 2021 - - -
P/E ratio 2021 -0,73x
Yield 2021 -
Capitalization 53,5 M 53,5 M -
Capi. / Sales 2021 3,21x
Capi. / Sales 2022 7,67x
Nbr of Employees 106
Free-Float 92,6%
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Number of Analysts 6
Last Close Price 1,00 $
Average target price 5,00 $
Spread / Average Target 400%
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Managers and Directors
David Domzalski President, Chief Executive Officer & Director
Tyler Zeronda Chief Financial Officer & Treasurer
Iain A. Stuart Chief Scientific Officer
Sharon Barbari Independent Director
Steven L. Basta Independent Director
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