0001104659-23-053593.txt : 20230501 0001104659-23-053593.hdr.sgml : 20230501 20230501081529 ACCESSION NUMBER: 0001104659-23-053593 CONFORMED SUBMISSION TYPE: 8-K PUBLIC DOCUMENT COUNT: 14 CONFORMED PERIOD OF REPORT: 20230428 ITEM INFORMATION: Entry into a Material Definitive Agreement ITEM INFORMATION: Regulation FD Disclosure ITEM INFORMATION: Financial Statements and Exhibits FILED AS OF DATE: 20230501 DATE AS OF CHANGE: 20230501 FILER: COMPANY DATA: COMPANY CONFORMED NAME: VYNE Therapeutics Inc. CENTRAL INDEX KEY: 0001566044 STANDARD INDUSTRIAL CLASSIFICATION: PHARMACEUTICAL PREPARATIONS [2834] IRS NUMBER: 453757789 STATE OF INCORPORATION: DE FISCAL YEAR END: 1231 FILING VALUES: FORM TYPE: 8-K SEC ACT: 1934 Act SEC FILE NUMBER: 001-38356 FILM NUMBER: 23870271 BUSINESS ADDRESS: STREET 1: 685 ROUTE 202/206, SUITE 301A CITY: BRIDGEWATER STATE: NJ ZIP: 08807 BUSINESS PHONE: 800-775-7936 MAIL ADDRESS: STREET 1: 685 ROUTE 202/206, SUITE 301A CITY: BRIDGEWATER STATE: NJ ZIP: 08807 FORMER COMPANY: FORMER CONFORMED NAME: Menlo Therapeutics Inc. DATE OF NAME CHANGE: 20180201 FORMER COMPANY: FORMER CONFORMED NAME: Menlo Therapeutics, Inc. DATE OF NAME CHANGE: 20170728 FORMER COMPANY: FORMER CONFORMED NAME: Tigercat Pharma, Inc. DATE OF NAME CHANGE: 20130104 8-K 1 tm2314020d1_8k.htm FORM 8-K
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UNITED STATES

SECURITIES AND EXCHANGE COMMISSION

Washington, D.C. 20549

 

FORM 8-K

 

CURRENT REPORT

Pursuant to Section 13 or 15(d) of the

Securities Exchange Act of 1934

 

Date of Report (Date of earliest event reported) April 28, 2023

 

VYNE Therapeutics Inc.

(Exact name of registrant as specified in its charter)

 

Delaware   001-38356   45-3757789

(State or other jurisdiction

of incorporation)

  

(Commission

File Number)

  

(IRS Employer

Identification Number)

 

685 Route 202/206 N., Suite 301

Bridgewater, New Jersey 08807

(Address of principal executive offices, including Zip Code)

 

(800) 775-7936

(Registrant’s telephone number, including area code)

 

Check the appropriate box below if the Form 8-K filing is intended to simultaneously satisfy the filing obligation of the registrant under any of the following provisions:

 

¨ Written communications pursuant to Rule 425 under the Securities Act (17 CFR 230.425)

 

¨ Soliciting material pursuant to Rule 14a-12 under the Exchange Act (17 CFR 240.14a-12)

 

¨ Pre-commencement communications pursuant to Rule 14d-2(b) under the Exchange Act (17 CFR 240.14d-2(b))

 

¨ Pre-commencement communications pursuant to Rule 13e-4(c) under the Exchange Act (17 CFR 240.13e-4(c))

 

Securities registered pursuant to Section 12(b) of the Act:

 

Title of each class   Trading
Symbol(s)		  

Name of each exchange

on which registered

Common Stock, $0.0001 par value   VYNE   The Nasdaq Stock Market LLC

 

Indicate by check mark whether the registrant is an emerging growth company as defined in Rule 405 of the Securities Act of 1933 (§230.405 of this chapter) or Rule 12b-2 of the Securities Exchange Act of 1934 (§240.12b-2 of this chapter). Emerging growth company x

 

If an emerging growth company, indicate by check mark if the registrant has elected not to use the extended transition period for complying with any new or revised financial accounting standards provided pursuant to Section 13(a) of the Exchange Act. x

 

 

 

 

 

Item 1.01 Entry into a Material Definitive Agreement.

 

On April 28, 2023, VYNE Therapeutics Inc. (the “Company”) and Tay Therapeutics Limited (formerly known as In4Derm Limited, “Tay”) entered into a License Agreement (the “License Agreement”) granting the Company a worldwide, exclusive license that is sublicensable through multiple tiers to exploit certain of Tay’s BD2-selective bromodomain and extra-terminal domain (“BET”) inhibitors in all fields. The parties entered into the License Agreement following the Company’s exercise of its exclusive option under the Evaluation and Option Agreement, dated as of April 30, 2021. The Company made a $3.75 million cash payment to Tay in connection with the exercise of its option.

 

Pursuant to the terms of the License Agreement, the Company has the sole responsibility for development, regulatory, marketing and commercialization activities to be conducted for the licensed products at the sole cost and discretion of the Company, and shall use commercially reasonable efforts to develop and, if approved, commercialize such products. VYNE may sublicense its rights to a third party without Tay’s consent. Pursuant to the License Agreement, a joint development committee consisting of one representative from each party reviews the progress of the development plan for the licensed products. The Company has agreed to make cash payments of up to an aggregate of $43.75 million upon the achievement of specified clinical development and regulatory approval milestones with respect to each licensed product in the U.S. for all indications. Tay is entitled to additional milestones upon the achievement of regulatory approvals in certain jurisdictions outside the U.S. up to an aggregate of $25.0 million for all indications. In addition, with respect to any products the Company commercializes under the License Agreement, the Company will pay tiered royalties to Tay on net sales of such licensed products by the Company, its affiliates, or sublicensees, of 5%, 7.5% and 10% based on tiered annual net sales bands subject to specified reductions. The Company is obligated to pay royalties until the later of (1) the tenth anniversary of the first commercial sale of the relevant licensed product, (2) the expiration of the last valid claim of the licensed patent rights covering such licensed product in such country and (3) the expiration of regulatory exclusivity for the relevant licensed product in the relevant country, on a licensed product-by-licensed product and country-by-country basis. The Company may terminate the License Agreement in its entirety, or on a product-by-product and country-by-country basis, for any reason or no reason upon 90 days’ notice. In addition, the License Agreement contains representations and warranties customary for this type of agreement.

 

The foregoing description of the License Agreement does not purport to be complete and is qualified in its entirety by reference to the License Agreement, a copy of which will be filed with the Company’s Quarterly Report on Form 10-Q for the period ending June 30, 2023.

 

Item 7.01 Regulation FD Disclosure.

 

On May 1, 2023, the Company issued a press release entitled “VYNE Therapeutics Announces Selection of Development Candidate VYN202, a Potential Best-in-Class Oral Small Molecule BD2-Selective BET Inhibitor for the Treatment of Immuno-Inflammatory Conditions.” A copy of the press release is attached hereto as Exhibit 99.1 and is incorporated by reference into this Item 7.01 of this Current Report on Form 8-K.

 

The information in Item 7.01 of this Form 8-K and Exhibit 99.1 attached hereto shall not be deemed “filed” for purposes of Section 18 of the Securities Exchange Act of 1934, as amended (the “Exchange Act”), or otherwise subject to the liabilities of that Section, or incorporated by reference in any filing under the Securities Act of 1933, as amended, or the Exchange Act, except as shall be expressly set forth by specific reference in such a filing.

 

 

 

 

Item 9.01. Financial Statements and Exhibits.

 

(d) Exhibits

 

The following exhibit is being furnished herewith.

 

Exhibit No.   Description
     
99.1   Press Release dated May 1, 2023.
     
104   Cover Page Interactive Data File (embedded within the Inline XBRL document)

 

 

 

 

SIGNATURES

 

Pursuant to the requirements of the Securities Exchange Act of 1934, as amended, the registrant has duly caused this report to be signed on its behalf by the undersigned hereunto duly authorized.

 

  VYNE THERAPEUTICS INC.
     
Date: May 1, 2023 By: /s/ Mutya Harsch
    Mutya Harsch
    Chief Legal Officer and General Counsel

 

 

 

 EX-99.1 2 tm2314020d1_ex99-1.htm EXHIBIT 99.1

 

Exhibit 99.1

 

 

 

VYNE Therapeutics Announces Selection of Development Candidate VYN202, a Potential Best-in-Class Oral Small Molecule BD2-Selective BET Inhibitor for the Treatment of Immuno-Inflammatory Conditions

 

Preclinical studies suggest VYN202 has the potential to be the most potent and selective BET inhibitor in development

 

VYN202 has demonstrated a potent anti-inflammatory and anti-fibrotic effect in multiple validated preclinical models of autoimmune disease

 

IND-enabling studies are ongoing in anticipation of an IND filing by year-end

 

BRIDGEWATER, N.J., May 1, 2023 -- VYNE Therapeutics Inc. (Nasdaq: VYNE) (“VYNE” or the “Company”), a clinical-stage biopharmaceutical company developing proprietary, innovative and differentiated therapies for the treatment of immuno-inflammatory conditions, today announced the selection of a development candidate for its oral BD2-selective bromodomain and extra-terminal (“BET”) inhibitor program, VYN202, for the treatment of immuno-inflammatory conditions. The lead candidate was selected by VYNE from a library of BD2-selective BET inhibitors that VYNE exclusively licensed from Tay Therapeutics following the receipt of a robust package of preclinical data, including encouraging results from well-validated animal models in various autoimmune disorders. VYNE also obtained rights to several other BD2-selective BET inhibitor compounds with attractive molecular profiles that the Company may develop, at its discretion, in the future.

 

“After extensive testing of multiple compounds across several well-validated preclinical models, we are pleased to have selected a development candidate for VYN202, which is specifically designed to be delivered orally, for the treatment of immuno-inflammatory conditions,” said David Domzalski, President and Chief Executive Officer of VYNE. “We are encouraged by the potential class-leading data and profile demonstrated by VYN202 in preclinical studies to date, and we look forward to further progressing our IND-enabling program and advancing VYN202 into clinical development.”

 

VYN202 targets BET proteins that play key roles in regulating gene transcription via epigenetic interaction (“reading”) with specific chemical motifs on H3 and H4 histone N-terminal tail domains that extend beyond a nucleosome unit. As epigenetic readers, BET proteins are super-enhancers of gene transcription that drive the hyperactive production of many pro-inflammatory proteins that characterize autoimmune and autoinflammatory diseases. Recent research has highlighted BET proteins as important contributors in regulating both B cell and T cell activity and, in preclinical models, BET inhibitors have demonstrated the potential to treat a range of immuno-inflammatory and fibrotic diseases.1,2 Early generation systemic BET inhibitors that inhibit both the BD1 and BD2 domains of BET proteins (pan-BD BET inhibitors) have historically been associated with gastrointestinal and hematological toxicities, such as thrombocytopenia (low platelet counts) in clinical trials.3 BD1 functionality has been associated with the regulation of genes responsible for maintaining homeostatic cellular processing, and that selectively inhibiting BD1 or BD1 and BD2 may contribute to unwanted dose limiting toxicities.1,4 VYN202 is designed to be significantly more selective in inhibiting BD2 than BD1 with the objective of limiting the potential of similar safety concerns associated with earlier pan-BD BET inhibitors.

 

VYNE has initiated IND-enabling studies for VYN202 and intends to submit an IND by year-end. Under VYNE’s license agreement with Tay, VYNE has exclusive worldwide rights to the compounds in its InhiBET™ platform, including VYN202, for all human disease applications.

 

1.Gilan et al, Science., 2020 April 24; 368(6489): 387

2.Kawahito et al, Pulm. Pharma. & Therp., 2021; 70:102057

3.Sun et al, Front. Pharmacol., 2021; 11:621093

4.Faivre et al, Nature, 2020; 578:306

 

 

 

 

About VYNE Therapeutics Inc.

 

VYNE’s mission is to improve the lives of patients by developing proprietary, innovative and differentiated therapies for the treatment of immuno-inflammatory conditions. The Company’s unique and proprietary bromodomain & extra-terminal (BET) domain inhibitors, which comprise its InhiBET™ platform, includes a locally administered pan-BET inhibitor (VYN201) and an orally available BD2-selective BET inhibitor (VYN202) that were licensed from Tay Therapeutics Limited.

 

For more information about VYNE Therapeutics Inc. or its product candidates, visit www.vynetherapeutics.com. VYNE may use its website to comply with its disclosure obligations under Regulation FD. Therefore, investors should monitor VYNE’s website in addition to following its press releases, filings with the U.S. Securities and Exchange Commission, public conference calls, and webcasts.

 

Cautionary Statement Regarding Forward-Looking Statements

 

This release includes forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995, including, but not limited to, statements regarding VYNE’s plans and development timelines for VYN202, including the submission of an IND by year end, VYNE’s InhiBET™ platform, and other statements regarding the future expectations, plans and prospects of VYNE. All statements in this press release which are not historical facts are forward-looking statements. Any forward-looking statements are based on VYNE’s current knowledge and its present beliefs and expectations regarding possible future events and are subject to risks, uncertainties and assumptions that could cause actual results to differ materially and adversely from those set forth or implied by such forward-looking statements. These risks and uncertainties include, but are not limited to: VYNE’s ability to successfully develop its product candidates; the timing of commencement of future non-clinical studies and clinical trials; VYNE’s ability to enroll patients and successfully progress, complete, and receive favorable results in, clinical trials for its product candidates; VYNE’s intentions and its ability to obtain additional funding, either through equity or debt financing transactions or collaboration arrangements; disruptions related to COVID-19 or another pandemic, epidemic or outbreak of a contagious disease, on the ability of VYNE’s suppliers to manufacture and provide materials for VYNE’s product candidates, initiating and retaining patients in clinical trials, operating results, liquidity and financial condition; developments and projections relating to competitors and the pharmaceuticals industry, including competing drugs and therapies; the timing or likelihood of regulatory filings and approvals or clearances for product candidates; VYNE’s ability to comply with various regulations applicable to its business, including Nasdaq continued listing rules; VYNE’s ability to create intellectual property and the scope of protection it is able to establish and maintain for intellectual property rights covering its product candidates, including the projected terms of patent protection; risks that any of VYNE’s patents may be held to be narrowed, invalid or unenforceable or one or more of VYNE’s patent applications may not be granted and potential competitors may also seek to design around VYNE’s granted patents or patent applications; the timing, costs or results of litigation, including litigation to protect its intellectual property; VYNE’s ability to successfully challenge intellectual property claimed by others; estimates of VYNE’s expenses, capital requirements, its needs for additional financing and its ability to obtain additional capital on acceptable terms or at all; VYNE’s ability to attract and retain key scientific or management personnel; and VYNE’s expectations regarding licensing, business transactions and strategic operations. For a discussion of other risks and uncertainties, and other important factors, any of which could cause VYNE’s actual results to differ from those contained in the forward-looking statements, see the section titled “Risk Factors” in VYNE’s Annual Report on Form 10-K for the year ended December 31, 2022, as well as discussions of potential risks, uncertainties, and other important factors in VYNE’s subsequent filings with the U.S. Securities and Exchange Commission. Although VYNE believes these forward-looking statements are reasonable, they speak only as of the date of this announcement and VYNE undertakes no obligation to update publicly such forward-looking statements to reflect subsequent events or circumstances, except as otherwise required by law. Given these risks and uncertainties, you should not rely upon forward-looking statements as predictions of future events.

 

Investor Relations:

 

John Fraunces

LifeSci Advisors, LLC

917-355-2395

jfraunces@lifesciadvisors.com

 

Tyler Zeronda
VYNE Therapeutics Inc.
908-458-9106
Tyler.Zeronda@vynetx.com

 

 

 

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Cover
Apr. 28, 2023
Cover [Abstract]  
Document Type 8-K
Amendment Flag false
Document Period End Date Apr. 28, 2023
Entity File Number 001-38356
Entity Registrant Name VYNE Therapeutics Inc.
Entity Central Index Key 0001566044
Entity Tax Identification Number 45-3757789
Entity Incorporation, State or Country Code DE
Entity Address, Address Line One 685 Route 202/206 N.
Entity Address, Address Line Two Suite 301
Entity Address, City or Town Bridgewater,
Entity Address, State or Province NJ
Entity Address, Postal Zip Code 08807
City Area Code 800
Local Phone Number 775-7936
Written Communications false
Soliciting Material false
Pre-commencement Tender Offer false
Pre-commencement Issuer Tender Offer false
Title of 12(b) Security Common Stock, $0.0001 par value
Trading Symbol VYNE
Security Exchange Name NASDAQ
Entity Emerging Growth Company true
Elected Not To Use the Extended Transition Period true
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