Item 1.01 Entry into a Material Definitive Agreement.
As previously disclosed, VYNE Therapeutics Inc. (the "Company") entered into
that certain Evaluation and Option Agreement (the "Option Agreement"), dated as
of April 30, 2021, with In4Derm Limited ("In4Derm"), providing the Company with
an exclusive option (the "Option") to obtain certain exclusive worldwide rights
to research, develop and commercialize products containing In4Derm's Bromodomain
and Extra-Terminal Domain inhibitors suitable for oral administration (the "Oral
BETi Compounds") during the period expiring upon the earlier of (i) 14 days
following the delivery of an agreed data package and selection of a lead
candidate by In4Derm and (ii) June 30, 2022 (the "Option Term"). In4Derm has
recently informed the Company that it will not have the complete data package
available for delivery of a lead candidate prior to the expiration date of the
Option on June 30, 2022. In consideration 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 entered into a Letter
Agreement on June 15, 2022 (the "Letter Agreement") to extend the Option Term to
February 28, 2023. The Company continues to expect to exercise its exclusive
Option for the Oral BETi Compounds by the end of 2022.
Pursuant to the terms of the Letter Agreement, VYNE has agreed to pay In4Derm
£300,000 to extend the Option Term, payable by June 30, 2022. In addition, VYNE
has agreed to pay In4Derm £850,000 payable upon In4Derm's discovery of at least
two Oral BETi Compounds with a molecular profile specified in a revised data
package. The foregoing fees are in addition to the other fees payable to In4Derm
under the terms of the Option Agreement.
The foregoing description of the Letter Agreement does not purport to be
complete and is qualified in its entirety by reference to the complete text of
the Letter Agreement, a copy of which will be filed with the Company's Quarterly
Report on Form 10-Q for the period ending June 30, 2022.
Item 8.01 Other Events.
The Company has completed patient enrollment in its Phase 2a clinical trial of
FMX114 for the treatment of mild-to-moderate atopic dermatitis. As a result of
the impact of COVID-19 on enrollment and other operations related to the trial
in Australia, the Company activated additional clinical trial sites in the
United States to support patient enrollment and expedite the completion of the
study. The Company expects to report topline results from this study in
approximately six to eight weeks.
On June 17, 2022, the Company issued a press release entitled "VYNE Therapeutics
Completes Enrollment in Phase 2a Trial of FMX114 for the Treatment of
Mild-to-Moderate Atopic Dermatitis." A copy of the press release is attached as
Exhibit 99.1 to this Current Report on Form 8-K and is incorporated by reference
herein.
Cautionary Statement Regarding Forward-Looking Statements
This Current Report on Form 8-K includes 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 results from its clinical trial
for FMX114, and other statements regarding the future expectations, plans and
prospects of VYNE. All statements in this report 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 receive and
report topline 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 progress, complete, and receive favorable results in,
clinical trials for its product candidates; VYNE's ability to exercise its
exclusive option with respect to an oral BETi candidate pursuant to the terms of
the option agreement with In4Derm Limited; 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 our product candidates,
initiating and retaining patients in clinical trials, operating results,
liquidity and financial condition; the regulatory approval process for VYNE's
product candidates, including any delay or failure in obtaining requisite
approvals; the potential market size of treatments for any diseases and market
adoption of products, if approved or cleared for commercial use, by physicians
and patients; 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; VYNE's defense of any litigation that may be initiated
against it; VYNE's expectations regarding licensing, business transactions and
strategic operations; VYNE's future financial performance and liquidity; and
volatility in VYNE's stock price may result in rapid and substantial increases
or decreases in the stock price that 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, 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, 2021, 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.
Item 9.01. Financial Statements and Exhibits.
(d) Exhibits
The following exhibit is being filed herewith.
Exhibit No. Description
99.1 Press Release, dated June 17, 2022.
104 Cover Page Interactive Data File (embedded within the Inline XBRL document)
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