VYNE THERAPEUTICS INC.: Completion of Material Definitive Agreement, Other Events, Financial Statements and Exhibits (Form 8-K) – Natural Self Esteem

Clause 1.01 Entering into a Material Definitive Agreement.

As previously announced, VYNE Therapeutics Inc. (the “Company”) this particular evaluation and option agreement (the “Option Agreement”) dated April 30, 2021With In4Derm Limited (“In4Derm”), whereby the Company has an exclusive option (the “Option”) to acquire certain exclusive worldwide rights to research, develop and commercialize products containing In4Derm’s bromodomain and extra terminal domain inhibitors that suitable for oral administration (the “Oral BETi Compounds”) during the period expiring on the earlier of (i) 14 days after delivery of an agreed data package and selection of a Lead Candidate by In4Derm and (ii). June 30, 2022 (the “Option Term”). In4Derm recently informed the company that it will not have the full data package for the delivery of a lead candidate before the option expiry date June 30, 2022. In light of the significant progress made by In4Derm in completing the data package and the Company’s desire to exercise its exclusive option for the oral BETi compounds, the parties concluded on June 15, 2022 (the “Letter Agreement”) to extend the Option Term
February 28, 2023. The Company continues to expect to exercise its exclusive option on the oral BETi compounds by the end of 2022.

Under the terms of the written agreement, VYNE has agreed to pay In4Derm £300,000 for the extension of the option term, payable by June 30, 2022. In addition, VYNE has agreed to pay In4Derm £850,000, payable if In4Derm discovers at least two oral BETi compounds with a molecular profile specified in a revised data package. The above fees are in addition to the other fees payable to In4Derm under the terms of the Option Agreement.

The foregoing description of the written agreement is not intended to be exhaustive and is qualified in its entirety by reference to the full text of the written agreement, a copy of which is being filed with the Company’s quarterly report on Form 10-Q for the period ended June 30, 2022.


Item 8.01 Other Events.


The Company has completed patient enrollment for its Phase 2a clinical trial of FMX114 in the treatment of mild to moderate atopic dermatitis. Due to the impact of COVID-19 on registration and other operations related to the study in Australiathe company activated additional clinical trial sites in The United States to support patient recruitment and expedite the completion of the study. The Company expects to report top-line results from this study in approximately six to eight weeks.

On June 17, 2022the company issued a press release titled “VYNE Therapeutics Completes Enrollment in Phase 2a Trial of FMX114 in Treatment of Mild-to-Moderate Atopic Dermatitis.” A copy of the news release is attached to this current report on Form 8-K as Exhibit 99.1 and is incorporated herein by reference.

Cautionary Note Regarding Forward-Looking Statements

This current report on Form 8-K contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995, including but not limited to statements regarding the exercise of the option with respect to its VYN202 program and the timing of reporting the results of its clinical trial for FMX114 and other statements regarding VYNE’s future expectations, plans and prospects. All statements in this report that are not historical facts are forward-looking statements. All forward-looking statements are based on VYNE’s current knowledge and current beliefs and expectations with respect to 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 in such forward-looking statements or implied differ. looking statements. These risks and uncertainties include, among others: VYNE’s ability to receive and report top-line results from its clinical trial for FMX114; 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 advance and complete clinical trials for its product candidates and achieve positive results; VYNE’s ability to co-exercise its exclusive option with respect to an oral BETi candidate under the terms of the Option Agreement In4Derm Limited; VYNE’s intentions and ability to obtain additional financing, either through equity or debt financing transactions or collaborative agreements; disruptions related to COVID-19 or any other pandemic, epidemic or infectious disease outbreak, the ability of VYNE’s suppliers to manufacture and supply materials for our product candidates, initiate and retain patients in clinical trials, operating results, liquidity and financial condition ; the regulatory approval process for VYNE’s product candidates, including delays or failure to obtain required approvals; the potential market size of treatments for diseases and the market acceptance of products by physicians and patients, if approved or cleared for commercial use; developments and forecasts relating to competitors and the pharmaceutical 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 the rules for continued listing on the Nasdaq; VYNE’s ability to create intellectual property and the level of protection it can establish and maintain for the intellectual property rights for its product candidates, including the expected terms of patent protection; risks that any of VYNE’s patents will be deemed limited, invalid or unenforceable, or that one or more of VYNE’s patent applications will not be granted and potential competitors may attempt to re-engineer VYNE’s granted patents or patent applications; the timing, cost, or outcome 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 need 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 managerial personnel; the defense of VYNE in any litigation that may be instituted against VYNE; VYNE’s expectations regarding licensing, business transactions and strategic operations; VYNE’s future financial performance and liquidity; and volatility in VYNE’s stock price can result in rapid and significant rises or falls in the stock price, which may or may not be related to the company’s operating performance or prospects. For a discussion of other risks and uncertainties and other important factors that could cause VYNE’s actual results to differ from those contained in the forward-looking statements, see the “Risk Factors” section of VYNE’s Annual Report on Form 10-K for the expired Year December 31, 2021and 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 publicly update any such forward-looking statements to reflect subsequent events or circumstances, except as required by law. Given these risks and uncertainties, you should not rely on forward-looking statements as predictions of future events.

Item 9.01. Financial statements and appendices.



(d) Exhibits


The following exhibit is hereby submitted.

Exhibit No. Description

99.1 press release, dated June 17, 2022.

104 Cover sheet Interactive data file (embedded in the inline XBRL document)

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