FALSE000156604400015660442024-08-142024-08-14

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) August 14, 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 August 14, 2024, VYNE Therapeutics Inc. issued a press release announcing its financial results for the quarter ended June 30, 2024. The press release is being furnished as Exhibit 99.1 to this Current Report and is incorporated herein by reference.
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
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: August 14, 2024
By:/s/ Mutya Harsch
Mutya Harsch
Chief Legal Officer and General Counsel


Exhibit 99.1

imagea.jpg
VYNE Therapeutics Reports Second Quarter 2024 Financial Results and Provides Business Update
•Initiated Phase 2b trial of VYN201 in nonsegmental vitiligo, with top-line results expected in mid-2025
•Phase 1a SAD/MAD trial of VYN202 progressing, with data from the SAD and MAD portions expected in Q3 and Q4 2024, respectively
•Balance sheet expected to fund key clinical milestones for VYN201 and VYN202 through the end of 2025

BRIDGEWATER, N.J., August 14, 2024 -- VYNE Therapeutics Inc. (Nasdaq: VYNE) (“VYNE” or the “Company”), a clinical-stage biopharmaceutical company focused on developing differentiated therapies to treat chronic inflammatory and immune-mediated conditions with high unmet need, today announced financial results as of and for the three and six months ended June 30, 2024 and provided a business update.

"We advanced our clinical programs in the second quarter of 2024, highlighted by the initiation of our Phase 2b trial of VYN201 and the Phase 1a trial of VYN202," said David Domzalski, President and Chief Executive Officer of VYNE. "We are pleased with the progress we are making with both clinical programs. We remain on track to report top-line data from our Phase 2b clinical trial for VYN201 in subjects with nonsegmental vitiligo in the middle of next year. We also expect to report top-line data from the single ascending dose portion of the Phase 1a trial of VYN202 this quarter, followed by results from the multiple ascending dose portion in the fourth quarter. Upon the successful completion of this Phase 1a trial, we plan to advance VYN202 into two Phase 1b proof-of-concept trials with top-line readouts in the second half of next year."

Recent Pipeline Updates

VYN201
•VYN201 is a locally administered pan-bromodomain ("BD") BET inhibitor designed as a “soft” drug to address diseases involving multiple, diverse inflammatory cell signaling pathways while providing low systemic exposure. VYNE initiated a Phase 2b trial of VYN201 in nonsegmental vitiligo in June 2024. The Phase 2b trial is 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 are being randomized at 1:1:1:1 ratio. Following the 24-week treatment period, subjects in the 1%, 2%, and 3% cohorts will continue treatment with their respective dose concentrations for an additional 28-week open label extension. Subjects in the vehicle group during the initial 24-week treatment period 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
•VYN202 is an oral small molecule BD2-selective BET inhibitor designed to achieve potential class-leading selectivity and potency (BD2 vs. BD1). A first-in-human Phase 1a single ascending dose/multiple ascending dose ("SAD/MAD") trial was initiated in June 2024. VYNE expects to report top-line results from the SAD and MAD portions of the trial in the third and fourth quarters of 2024, respectively. If the Phase 1a trial is successfully completed, VYNE plans to initiate Phase 1b trials in adult subjects with moderate-to-severe plaque psoriasis and moderate-to-severe rheumatoid arthritis, with top-line results anticipated in the second half of 2025.

Recent Corporate Update

1

•In July, VYNE appointed Subhashis Banerjee, M.D., as Senior Vice President of Clinical Development. Dr. Banerjee is a trained immunologist and rheumatologist with over 25 years of drug development experience at large pharmaceutical companies, including the development of therapies for psoriasis and arthritic conditions. He most recently served as Vice President & Disease Area Head, Rheumatology and Dermatology at Bristol Myers Squibb. Dr. Banerjee played a key role in the development strategy of immunology assets across multiple platforms for several immune-mediated diseases, including SOTYKTU® (deucravacitinib), ORENCIA® (abatacept), clazakizumab (anti-IL-6 antibody), TALTZ® (ixekizumab, anti-IL-17 antibody) and XELJANZ® (tofacitinib).

Upcoming Conference Participation

•H.C. Wainwright 26th Annual Global Investment Conference, September 9-11, 2024, New York, NY
•Stifel Immunology and Inflammation Virtual Summit, September 17-18, 2024
Financial Results as of and for the Second Quarter Ended June 30, 2024
Cash position. As of June 30, 2024, VYNE had cash, cash equivalents, restricted cash and marketable securities of $78.1 million. VYNE believes its cash, cash equivalents, restricted cash and marketable securities as of June 30, 2024 will be sufficient to fund its operations through the end of 2025.
Revenues. Revenues totaled $0.2 million and $0.1 million for each of the quarters ended June 30, 2024 and 2023, respectively, 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 June 30, 2024 were $7.3 million, representing an increase of $0.1 million, or 1.0%, compared to $7.2 million for the quarter ended June 30, 2023. The increase was primarily driven by expenses related to preparatory and clinical trial activities for a Phase 2b trial of VYN201 in subjects with nonsegmental vitiligo, which was initiated in June 2024, of $3.2 million, including a $1.0 million development milestone payment due to Tay Therapeutics Ltd. ("Tay") upon the initiation of the Phase 2b trial. In addition, employee-related expenses increased by $0.3 million following the hiring of additional research and development personnel. These increases were partially offset by a decrease in expenses associated with VYN202 of $3.5 million, primarily driven by lower amounts owed to Tay under the license agreement with respect to VYN202 (the "VYN202 License Agreement"). In April 2023, VYNE made a one-time cash payment of $3.75 million to Tay in connection with entering into the VYN202 License Agreement. In the second quarter of 2024, the Company incurred a $1.0 million development milestone payment due to Tay following the initiation of a Phase 1a SAD/MAD trial of VYN202.
General and administrative expenses. VYNE’s general and administrative expenses for the quarter ended June 30, 2024 were $3.3 million, representing an increase of $0.1 million, or 2.1%, compared to $3.2 million for the quarter ended June 30, 2023. The increase was primarily driven by consulting and professional fees.
Net loss. Net loss and net loss per share for the quarter ended June 30, 2024 were $9.4 million and $0.22, respectively, compared to a net loss and net loss per share of $10.1 million and $3.09, respectively for the comparable period in 2023.

About VYNE Therapeutics Inc.

VYNE is a clinical-stage biopharmaceutical company focused on developing differentiated therapies to treat chronic inflammatory and immune-mediated conditions with high unmet need. VYNE's unique and proprietary BET inhibitors, which comprise its InhiBET™ platform, are designed to overcome limitations of early generation BET inhibitors by leveraging alternative routes of administration and enhanced selectivity.

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
2

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

Media Relations:
Mike Beyer
Sam Brown Inc.
312-961-2502
mikebeyer@sambrown.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 VYNE's ability to successfully complete its Phase 1a trial of VYN202, future clinical trials of VYN202, the expected enrollment and timing for reporting top-line results from trials of VYN201 and VYN202, 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.

Third-party products and company names mentioned herein may be the trademarks of their respective owners.

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VYNE THERAPEUTICS INC.
CONDENSED CONSOLIDATED BALANCE SHEETS
(U.S. dollars in thousands, except share and per share data)
(Unaudited)
June 30,December 31,
20242023
Assets
Current Assets:
Cash and cash equivalents$29,609 $30,620 
Restricted cash46 54 
Investment in marketable securities48,492 62,633 
Prepaid and other current assets5,629 2,656 
Total Current Assets83,776 95,963 
Non-current Assets:
Operating lease right-of-use assets151 207 
Non-current prepaid expenses and other assets2,721 1,515 
Total Non-current Assets2,872 1,722 
Total Assets$86,648 $97,685 
Liabilities and Stockholders’ Equity
Current Liabilities:
Trade payables$4,516 $1,659 
Accrued expenses5,069 4,119 
Employee related obligations736 1,645 
Operating lease liabilities120 115 
Other current liabilities1,313 — 
Total Current Liabilities11,754 7,538 
Long-term Liabilities:
Non-current operating lease liabilities25 99 
Other liabilities— 1,313 
Total Long-term Liabilities25 1,412 
Total Liabilities11,779 8,950 
Commitments and Contingencies
Stockholders' Equity:
Preferred stock: $0.0001 par value; 20,000,000 shares authorized at June 30, 2024 and December 31, 2023; no shares issued and outstanding at June 30, 2024 and December 31, 2023— — 
Common stock: $0.0001 par value; 150,000,000 shares authorized at June 30, 2024 and December 31, 2023; 14,536,124 and 14,098,888 shares issued and outstanding at June 30, 2024 and December 31, 2023, respectively1 1 
Additional paid-in capital781,917 780,044 
Accumulated other comprehensive (loss) income(58)26 
Accumulated deficit(706,991)(691,336)
Total Stockholders' Equity74,869 88,735 
Total Liabilities and Stockholders’ Equity$86,648 $97,685 
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VYNE THERAPEUTICS INC.
CONDENSED CONSOLIDATED STATEMENTS OF OPERATIONS
(U.S. dollars in thousands, except per share data)
(Unaudited)
Three Months Ended
June 30,		Six Months Ended
June 30,
2024202320242023
Revenues
Royalty revenues$198 $135 $296 $234 
Total Revenues198 135 296 234 
Operating Expenses:
Research and development7,306 7,233 11,014 9,967 
General and administrative3,288 3,220 7,058 6,460 
Total Operating Expenses10,594 10,453 18,072 16,427 
Operating Loss(10,396)(10,318)(17,776)(16,193)
Other income, net1,001 280 2,140 543 
Loss from continuing operations before income taxes(9,395)(10,038)(15,636)(15,650)
Income tax expense— — — — 
Loss from continuing operations(9,395)$(10,038)(15,636)(15,650)
Loss from discontinued operations, net of income taxes(11)(20)(19)(30)
Net Loss$(9,406)$(10,058)$(15,655)$(15,680)
Loss per share from continuing operations, basic and diluted$(0.22)$(3.08)$(0.37)$(4.81)
Income (loss) per share from discontinued operations, basic and diluted$0.00 $(0.01)$0.00 $(0.01)
Loss per share, basic and diluted$(0.22)$(3.09)$(0.37)$(4.82)
Weighted average shares outstanding - basic and diluted42,586 3,274 42,584 3,265 


5
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Aug. 14, 2024
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Document Period End Date Aug. 14, 2024
Entity Registrant Name VYNE Therapeutics Inc
Entity Central Index Key 0001566044
Amendment Flag false
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Entity File Number 001-38356
Entity Tax Identification Number 45-3757789
Entity Address, Address Line One 685 Route 202/206 N., Suite 301
Entity Address, City or Town Bridgewater
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Entity Address, Postal Zip Code 08807
City Area Code 800
Local Phone Number 775-7936
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Title of 12(b) Security Common Stock, $0.0001 par value
Trading Symbol VYNE
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Entity Emerging Growth Company false
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