FALSE000156604400015660442024-05-092024-05-09

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) May 9, 2024
___________________________________________________________________________________________________________
VYNE Therapeutics Inc.
(Exact name of registrant as specified in its charter)
___________________________________________________________________________________________________________
Delaware001-3835645-3757789
(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 classTrading
Symbol(s)		Name of each exchange
on which registered
Common Stock, $0.0001 par valueVYNEThe 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 ☐
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. ☐




Item 2.02 Results of Operations and Financial Condition.
On May 9, 2024, VYNE Therapeutics Inc. issued a press release announcing its financial results for the quarter ended March 31, 2024. The press release is being furnished as Exhibit 99.1 to this Current Report.
The information in Item 2.02 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 exhibits are being furnished herewith.
Exhibit No.Description
99.1
104Cover 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 9, 2024
By:/s/ Mutya Harsch
Mutya Harsch
Chief Legal Officer and General Counsel


Exhibit 99.1

imagea.jpg
VYNE Reports First Quarter 2024 Financial Results and Provides Business Update
•Design of Phase 2b trial for VYN201 in nonsegmental vitiligo finalized and on track to begin this quarter
•Phase 2b trial expected to enroll approximately 160 subjects with either active or stable nonsegmental vitiligo and will evaluate VYN201 gel in 1%, 2% and 3% concentrations compared to vehicle for 24 weeks, followed by a 28-week active treatment extension
•IND clearance received for oral BD2-selective BET inhibitor, VYN202; anticipate first healthy volunteers to be dosed in Phase 1a SAD/MAD trial this quarter

BRIDGEWATER, N.J., May 9, 2024 -- VYNE Therapeutics Inc. (Nasdaq: VYNE) (“VYNE” or the “Company”), a clinical-stage biopharmaceutical company focused on developing proprietary, innovative and differentiated therapies for the treatment of immuno-inflammatory conditions, today announced financial results as of and for the three months ended March 31, 2024 and provided a business update.

“During the first quarter, we made steady progress in advancing our VYN201 program toward a Phase 2b trial," said David Domzalski, President and CEO of VYNE. "We are rapidly activating clinical trial sites and expect to dose the first subject in the trial this quarter. In addition, we recently received IND clearance for our VYN202 program to proceed and expect to dose the first healthy volunteers in our Phase 1a trial this quarter. We look forward to updating our stakeholders on our progress in the coming months."

Recent Pipeline Updates

VYN201, a locally-administered pan-BD BET inhibitor:
•VYNE expects to enroll the first vitiligo subject in the Phase 2b trial for VYN201 this quarter. The Phase 2b trial will enroll subjects with either active or stable nonsegmental vitiligo and will be a randomized, double-blind, vehicle-controlled trial evaluating the efficacy, safety and pharmacokinetics of once-daily VYN201 gel in three dose cohorts (1%, 2% and 3% concentrations) compared to vehicle for 24 weeks. Subjects will be randomized at 1:1:1:1 ratio. Following the 24-week treatment period, subjects in the vehicle group will be equally re-randomized to receive VYN201 1%, 2% or 3% gel for an additional 28 weeks. VYNE expects to enroll approximately 40 subjects in each arm and to report top-line results from the 24-week double-blind portion of the trial in mid-2025.

VYN202, an oral small molecule BD2-selective BET inhibitor:
•VYNE's Investigational New Drug application for VYN202 was recently cleared by the U.S. Food & Drug Administration, and VYNE expects to dose the first healthy volunteers in the Phase 1a single ascending dose/multiple ascending dose ("SAD/MAD") trial this quarter. VYNE expects to report top-line results from the SAD/MAD trial in the second half of this year. If the Phase 1a trial is successfully completed, VYNE plans to initiate Phase 1b trials in subjects with moderate-to-severe plaque psoriasis and moderate-to-severe adult-onset rheumatoid arthritis, with top-line results anticipated in the second half of 2025.

Upcoming Conference Participation

•2024 Society for Investigative Dermatology Annual Meeting - Dr. Iain Stuart, Chief Scientific Officer of VYNE, will present preclinical and Phase 1b data for VYN201 in vitiligo. The conference is being held on May 15-18, 2024 in Dallas, Texas.
Financial Results as of and for the First Quarter Ended March 31, 2024
1

Cash position. As of March 31, 2024, VYNE had cash, cash equivalents, restricted cash and marketable securities of $86.0 million. VYNE believes its cash, cash equivalents, restricted cash and marketable securities as of March 31, 2024 will be sufficient to fund its operations through the end of 2025. See Note 1 to VYNE’s unaudited interim condensed consolidated financial statements included in VYNE’s Quarterly Report on Form 10-Q filed today for additional discussion on liquidity and capital resources.
Revenues. Revenues totaled $0.1 million for each of the three months ended March 31, 2024 and 2023, consisting of royalty revenue from the Company's royalty agreement with LEO Pharma, to whom VYNE previously licensed the rights to Finacea foam.

Research and development expenses. VYNE’s research and development expenses for the quarter ended March 31, 2024 were $3.7 million, representing an increase of $1.0 million, or 35.6%, compared to $2.7 million for the quarter ended March 31, 2023. The increase was primarily driven by preparatory activities for the Phase 1 trials for VYN202 and Phase 2b trial for VYN201 of $0.7 million and $0.3 million, respectively.
General and administrative expenses. VYNE’s general and administrative expenses for the quarter ended March 31, 2024 were $3.8 million, representing an increase of $0.5 million, or 16.4%, compared to $3.2 million for the quarter ended March 31, 2023. The increase was primarily driven by $0.3 million of consulting and professional fees and $0.2 million of employee-related expenses.
Net loss. Net loss and net loss per share for the quarter ended March 31, 2024 were $6.2 million and $0.15, respectively, compared to a net loss and net loss per share of $5.6 million and $1.74, respectively for the comparable period in 2023.

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, include a locally administered pan-BD 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.

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

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 future clinical trials for VYN201 and VYN202, the expected timing for reporting top-line results from those trials, and VYNE’s projected cash runway, 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 preclinical studies and clinical trials; VYNE’s ability to complete and receive favorable results from clinical trials of its product candidates; VYNE’s ability to obtain additional funding, either through equity or debt financing transactions or collaboration arrangements; and VYNE’s ability to comply with various regulations applicable to its business. 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, 2023, and VYNE’s other filings from time to time 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.
2

VYNE THERAPEUTICS INC.
CONDENSED CONSOLIDATED BALANCE SHEETS
(U.S. dollars in thousands, except share and per share data)
(Unaudited)
March 31December 31
20242023
Assets
Current Assets:
Cash and cash equivalents$19,065 $30,620 
Restricted cash54 54 
Investment in marketable securities66,885 62,633 
Prepaid and other expenses4,219 2,656 
Total Current Assets90,223 95,963 
Non-current Assets:
Operating lease right-of-use assets180 207 
Non-current prepaid expenses and other assets1,273 1,515 
Total Non-current Assets1,453 1,722 
Total Assets$91,676 $97,685 
Liabilities and Stockholders’ Equity
Current Liabilities:
Trade payables$2,795 $1,659 
Accrued expenses3,642 4,119 
Employee related obligations376 1,645 
Operating lease liabilities117 115 
Total Current Liabilities6,930 7,538 
Long-term Liabilities:
Non-current operating lease liabilities63 99 
Other liabilities1,313 1,313 
Total Long-term Liabilities1,376 1,412 
Total Liabilities8,306 8,950 
Commitments and Contingencies
Stockholders' Equity:
Preferred stock: $0.0001 par value; 20,000,000 shares authorized at March 31, 2024 and December 31, 2023, respectively; no shares issued and outstanding at March 31, 2024 and December 31, 2023, respectively— — 
Common stock: $0.0001 par value; 150,000,000 shares authorized at March 31, 2024 and December 31, 2023; 14,301,688 and 14,098,888 shares issued and outstanding at March 31, 2024 and December 31, 2023, respectively1 1 
Additional paid-in capital781,024 780,044 
Accumulated other comprehensive (loss) income(70)26 
Accumulated deficit(697,585)(691,336)
Total Stockholders' Equity83,370 88,735 
Total Liabilities and Stockholders’ Equity$91,676 $97,685 
3

VYNE THERAPEUTICS INC.
CONDENSED CONSOLIDATED STATEMENTS OF OPERATIONS
(U.S. dollars in thousands, except per share data)
(Unaudited)
Three Months Ended March 31,
20242023
Revenues
Royalty revenues$98 $99 
Total Revenues98 99 
Operating Expenses:
Research and development3,708 2,734 
General and administrative3,770 3,240 
Total Operating Expenses7,478 5,974 
Operating Loss(7,380)(5,875)
Other income, net1,139 263 
Loss from continuing operations before income taxes(6,241)(5,612)
Income tax expense— — 
Loss from continuing operations(6,241)$(5,612)
Loss from discontinued operations, net of income taxes(8)(10)
Net Loss$(6,249)$(5,622)
Loss per share from continuing operations, basic and diluted$(0.15)$(1.74)
Loss per share from discontinued operations, basic and diluted$0.00 $0.00 
Loss per share, basic and diluted$(0.15)$(1.74)
Weighted average shares outstanding - basic and diluted42,581 3,255 


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May 09, 2024
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