FALSE000156604400015660442023-08-142023-08-14

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, 2023
___________________________________________________________________________________________________________
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, 2023, VYNE Therapeutics Inc. issued a press release announcing its financial results for the quarter ended June 30, 2023. The press release is being furnished as Exhibit 99.1.
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: August 14, 2023By:/s/ Mutya Harsch
Mutya Harsch
Chief Legal Officer and General Counsel


Exhibit 99.1

image.jpg
VYNE Therapeutics Reports Second Quarter 2023 Financial Results and Provides Business Update

Anticipate announcing preliminary Phase 1b safety and efficacy data for pan-BD BET inhibitor, VYN201, in nonsegmental vitiligo in Q3 2023

IND-enabling studies for VYN202, a potential best-in-class oral small molecule BD2-selective BET inhibitor, are ongoing in anticipation of indication selection in Q4 2023 and initiating a Phase 1 trial in Q1 2024

BRIDGEWATER, N.J., August 14, 2023 -- 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 for the three and six months ended June 30, 2023 and provided a business update.

“We continue to make excellent progress in advancing our two novel small molecule BET inhibitors, VYN201 and VYN202, for the treatment of immuno-inflammatory conditions,” said David Domzalski, President and Chief Executive Officer of VYNE. “As we prepare to report the first clinical trial results for VYN201 in patients with non-segmental vitiligo later this quarter, we are pleased by the compound’s positive safety profile and pharmacokinetics results in healthy volunteers that we reported in the first quarter. Taken together, the Phase 1a data and the consistent results observed across multiple preclinical models of VYN201 suggest that BET inhibition has the potential to be an effective new treatment approach to address several immuno-inflammatory diseases, including vitiligo. We are also making steady progress in our IND-enabling studies for our first oral BET inhibitor, VYN202, and anticipate selection of a lead indication in the fourth quarter of 2023 followed by the initiation of clinical testing in the first quarter of 2024.”

Recent Business Updates

VYN201, a locally-administered pan-BD BET inhibitor:
•Upcoming safety and efficacy data readout in Phase 1b trial of vitiligo patients. The Company expects to report preliminary Phase 1b data in the third quarter of 2023, followed by final results in October 2023. The Phase 1a clinical results for VYN201 showed a positive safety profile, with no reported serious adverse events, dose adjustments, clinically relevant treatment emergent adverse events, abnormal clinical laboratory results, electrocardiogram findings or patient withdrawals from the trial. Furthermore, VYN201 showed minimal systemic exposure and all hematological parameters, including platelet counts, were within normal ranges in the Phase 1a portion of the trial.

VYN202, an oral small molecule BD2-selective BET inhibitor:
•IND submission for VYN202 expected by year-end. IND-enabling studies are ongoing, and the Company intends to select a lead indication in the fourth quarter of 2023. The IND submission for VYN202 is expected by year-end in anticipation of commencing a Phase 1 trial in the first quarter of 2024.

•On May 1, 2023, the Company announced selection of a lead development candidate, VYN202, a potential best-in-class oral small molecule BD2-selective BET inhibitor for the treatment of immuno-inflammatory conditions. The lead candidate was chosen from a library of BD2-selective BET inhibitors based on a robust package of encouraging preclinical data developed from a series of well-validated animal models in various autoimmune disorders.

1

Financial Performance
(in thousands)		Three Months Ended June 30Six Months Ended June 30
2023202220232022
Loss from continuing operations (GAAP)$(10,038)$(8,235)$(15,650)$(16,929)
Adjusted loss from continuing operations (non-GAAP)*$(9,162)$(7,072)$(13,918)$(14,521)
Net loss (GAAP)$(10,058)$(8,476)$(15,680)$(3,806)
Adjusted net loss (non-GAAP)*$(9,182)$(7,313)$(13,948)$(1,750)
*See “Non-GAAP Financial Measure” elsewhere in this earnings release.
Liquidity and Capital Resources
As of June 30, 2023, VYNE had cash and cash equivalents and restricted cash of $20.7 million. VYNE currently anticipates that its cash and cash equivalents and restricted cash as of June 30, 2023 will be sufficient to fund its operations through the end of 2023, without giving effect to any potential business development transactions or financing activities, including any sales under its equity line of credit with Lincoln Park or the Company’s at-the-market offering program. See Note 1 to VYNE’s unaudited interim condensed consolidated financial statements included in VYNE’s Quarterly Report on Form 10-Q for the quarter ended June 30, 2023 for additional discussion on liquidity and capital resources.
Financial Results for the Second Quarter Ended June 30, 2023
Revenues. Revenues totaled $0.1 million for each of the quarters ended June 30, 2023 and 2022, consisting of royalty revenue.

Research and development expenses. VYNE’s research and development expenses for the quarter ended June 30, 2023 were $7.2 million, as compared to $4.1 million for the comparable period in 2022. The increase was primarily driven by expenses related to the development of VYN202, including the payment made in connection with entering into the VYN202 License Agreement. This increase was partially offset by lower employee-related expenses and decreased spending for FMX114.
Selling, general and administrative expenses. VYNE’s selling, general and administrative expenses for the quarter ended June 30, 2023 were $3.2 million, compared to $4.3 million for the comparable period in 2022. The decrease was primarily driven by decreased consulting and professional fees and lower rent and corporate insurance expenses.
Net loss. Net loss and net loss per share for the quarter ended June 30, 2023 was $10.1 million and $3.09, respectively, compared to a net loss and net loss per share of $8.5 million and $2.63 for the comparable period in 2022, respectively. Net loss reported for the second quarter of 2022 reflected the impact of $0.2 million from discontinued operations, net of income taxes.

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-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 VYNE’s timing for announcing Phase 1b data for VYN201, VYNE’s plans, regulatory filings and development timelines for VYN202, VYNE’s InhiBET™ platform, VYNE’s ability to fund its operations through the end of 2023 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 the 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; VYNE’s ability to comply with various regulations applicable to its business; 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; 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 expectations regarding licensing, business transactions and strategic operations; VYNE’s future financial performance and liquidity; and potential volatility in VYNE’s stock price that may result in rapid and substantial increases or decreases in the stock price that may or may not be related to VYNE’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, 2022, VYNE’s Quarterly Report on Form 10-Q for the quarter ended June 30, 2023, 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.






VYNE THERAPEUTICS INC.
CONDENSED CONSOLIDATED BALANCE SHEETS
(U.S. dollars in thousands, except share and per share data)
(Unaudited)
June 30,December 31
20232022
Assets
Current Assets:
Cash and cash equivalents$20,634 $30,908 
Restricted cash67 67 
Trade receivables, net of allowances234 173 
Amount due from sale of MST Franchise— 5,000 
Prepaid and other expenses2,024 2,127 
Total Current Assets22,959 38,275 
Non-current prepaid expenses and other assets2,000 2,483 
Total Assets$24,959 $40,758 
Liabilities, Mezzanine Equity and Stockholders’ Equity
Current Liabilities:
Trade payables$1,159 $2,386 
Accrued expenses4,379 4,381 
Employee related obligations836 2,372 
Liability for employee severance benefits— 206 
Total Current Liabilities6,374 9,345 
Other liabilities1,313 — 
Total Liabilities7,687 9,345 
Commitments and Contingencies
Mezzanine Equity:
Convertible Preferred Stock: $0.0001 par value; 20,000,000 shares authorized at June 30, 2023 and December 31, 2022; Series A Preferred Stock: 0 and 3,000 shares issued and outstanding at June 30, 2023 and December 31, 2022, respectively
— 211 
Stockholders’ Equity:
Common stock: $0.0001 par value; 150,000,000 shares authorized at June 30, 2023 and December 31, 2022; 3,282,479 and 3,229,704 shares issued and outstanding at June 30, 2023 and December 31, 2022, respectively
— — 
Additional paid-in capital695,836 693,937 
Accumulated deficit(678,564)(662,735)
Total Stockholders’ Equity
17,272 31,202 
Total Liabilities, Mezzanine Equity and Stockholders’ Equity$24,959 $40,758 


VYNE THERAPEUTICS INC.
CONDENSED CONSOLIDATED STATEMENTS OF OPERATIONS
(U.S. dollars in thousands, except per share data)
(Unaudited)
Three Months Ended June 30Six Months Ended June 30
2023202220232022
Revenues
Royalty revenues$135 $126 $234 $304 
Total revenues135 126 234 304 
Operating expenses:
Research and development7,233 4,108 9,967 8,560 
Selling, general and administrative3,220 4,305 6,460 8,722 
Total operating expenses10,453 8,413 16,427 17,282 
Operating loss(10,318)(8,287)(16,193)(16,978)
Other income, net280 52 543 49 
Loss from continuing operations before income taxes(10,038)(8,235)(15,650)(16,929)
Income tax expense— — — — 
Loss from continuing operations(10,038)$(8,235)(15,650)(16,929)
(Loss) income from discontinued operations, net of income taxes(20)(241)(30)13,123 
Net loss$(10,058)$(8,476)$(15,680)$(3,806)
Loss per share from continuing operations, basic and diluted$(3.08)$(2.56)$(4.81)$(5.38)
(Loss) income per share from discontinued operations, basic and diluted$(0.01)$(0.07)$(0.01)$4.17 
Loss per share, basic and diluted$(3.09)$(2.63)$(4.82)$(1.21)
Weighted average shares outstanding - basic and diluted3,274 3,218 3,265 3,148 

Non-GAAP Financial Measures
In evaluating the operating performance of its business, VYNE’s management considers adjusted net loss, adjusted net loss per share, adjusted loss from continuing operations, adjusted total operating expenses (including adjusted research and development expense and adjusted selling, general and administrative expense), adjusted operating loss and adjusted loss per share from continuing operations. These non-GAAP financial measures exclude stock-based compensation charges that are required by GAAP. The Company believes that these non-GAAP financial measures provide management, analysts, investors and other users of the Company’s financial information with meaningful supplemental information regarding the performance of the Company’s business by excluding the effect of certain non-cash expenses and items that VYNE believes may not be indicative of its operating performance, because they are either unusual and VYNE does not expect them to recur in the ordinary course of its business, or they are unrelated to the ongoing operation of the business in the ordinary course. These non-GAAP financial measures should not be considered superior to, but rather in addition to, other financial measures prepared by the Company in accordance with GAAP, including the period-to-period results. The Company’s method of determining these non-GAAP financial measures may be different from other companies’ methods and, therefore, may not be comparable to those used by other companies, and the Company does not recommend the sole use of these non-GAAP measures to assess its financial and earnings performance. For reasons noted above, the Company is presenting certain non-GAAP financial measures for the three and six months ended June 30, 2023 and 2022. The following tables reconcile non-GAAP financial measures presented in this press release.




The following tables provides detailed reconciliations of various other income statement data between GAAP and non-GAAP amounts for the three and six months ended June 30, 2023 and 2022 (in thousands, except per share data):
Reconciliation of net loss to adjusted net loss and net loss per share to adjusted net loss per share:
Three Months Ended June 30Six Months Ended June 30
(in thousands, except per share data)2023202220232022
Net loss (GAAP)$(10,058)$(8,476)$(15,680)$(3,806)
    Add-back: stock-based compensation expense876 1,163 1,732 2,056 
Adjusted net loss (non-GAAP)$(9,182)$(7,313)$(13,948)$(1,750)
Net loss per share, basic and diluted (GAAP)$(3.09)$(2.63)$(4.82)$(1.21)
     Add-back: stock-based compensation expense0.27 0.36 0.53 0.65 
Adjusted net loss per share, basic and diluted (non-GAAP)$(2.82)$(2.27)$(4.29)$(0.56)
Weighted average number of shares outstanding, basic and diluted3,274 3,218 3,265 3,148 


Reconciliation of loss from continuing operations to adjusted loss from continuing operations; research and development expense to adjusted research and development expense; selling, general and administrative expense to adjusted selling, general and administrative expense; total operating expenses to adjusted total operating expenses; operating loss to adjusted operating loss; and loss per share from continuing operations to adjusted loss per share from continuing operations:
Three Months Ended June 30Six Months Ended June 30
(in thousands, except per share data)2023202220232022
Loss from continuing operations (GAAP)$(10,038)$(8,235)$(15,650)$(16,929)
Add-back: stock-based compensation expense876 1,163 1,732 2,408 
Adjusted loss from continuing operations (non-GAAP)$(9,162)$(7,072)$(13,918)$(14,521)
Research and development expense (GAAP)$7,233 $4,108 $9,967 $8,560 
Less: stock-based compensation expense(138)(393)(182)(622)
Adjusted research and development expense (non-GAAP)$7,095 $3,715 $9,785 $7,938 
Selling, general and administrative expense (GAAP)$3,220 $4,305 $6,460 $8,722 
Less: stock-based compensation expense(738)(770)(1,550)(1,786)
Adjusted selling, general and administrative expense (non-GAAP)$2,482 $3,535 $4,910 $6,936 
Total operating expenses (GAAP)$10,453 $8,413 $16,427 $17,282 
Less: stock-based compensation expense(876)(1,163)(1,732)(2,408)
Adjusted total operating expenses (non-GAAP)$9,577 $7,250 $14,695 $14,874 
Operating loss (GAAP)$(10,318)$(8,287)$(16,193)$(16,978)
Add back: stock-based compensation expense876 1,163 1,732 2,408 
Adjusted operating loss (non-GAAP)$(9,442)$(7,124)$(14,461)$(14,570)
Loss per share from continuing operations, basic and diluted (GAAP)$(3.08)$(2.56)$(4.81)$(5.38)
Add back: stock-based compensation expense0.27 0.36 0.53 0.76 
Adjusted loss per share from continuing operations, basic and diluted (non-GAAP)$(2.81)$(2.20)$(4.28)$(4.62)
Weighted average number of shares outstanding - basic and diluted3,274 3,218 3,265 3,148 

v3.23.2
Document and Entity Information Document
Aug. 14, 2023
Cover [Abstract]  
Document Type 8-K
Document Period End Date Aug. 14, 2023
Entity Registrant Name VYNE Therapeutics Inc
Entity Central Index Key 0001566044
Amendment Flag false
Entity Incorporation, State or Country Code DE
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
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
Entity Ex Transition Period true
VYNE Therapeutics (NASDAQ:VYNE)
Historical Stock Chart
From Apr 2024 to May 2024 Click Here for more VYNE Therapeutics Charts.
VYNE Therapeutics (NASDAQ:VYNE)
Historical Stock Chart
From May 2023 to May 2024 Click Here for more VYNE Therapeutics Charts.