Full Press Release Details
VYNE Therapeutics Reports 2025 Second Quarter
Financial Results and Provides Business Update
BRIDGEWATER, N.J., August 14, 2025 -- 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 reported financial results
as of and for the quarter ended June 30, 2025.
The Company is actively evaluating opportunities
to enhance the value of its pipeline programs. VYNE's oral BD2-selective BET inhibitor, VYN202, has recently demonstrated a promising
efficacy signal in a Phase 1b clinical trial in moderate to severe plaque psoriasis, as well as disease-modifying potential across multiple
translational models of fibro-inflammatory disease and hematologic malignancies. These new data, in areas such as nephrology, pulmonology,
rheumatology and myeloproliferative neoplasms, among others, underscore the therapeutic potential of the program. As previously announced,
the Company is seeking a partner for its topical BET inhibitor, repibresib.
"The strength of our recent clinical
and preclinical findings for VYN202 provides a compelling scientific foundation as we determine the best path forward for the VYN202
program," said David Domazalski, President and Chief Executive Officer of VYNE. "In conjunction, we have implemented cost reductions that are expected to extend our cash runway into the first half of
2027, giving us additional flexibility during this period."
VYN202, an oral small molecule BD2-selective BET inhibitor:
Repibresib gel, a locally-administered small
molecule pan-BD BET inhibitor:
Financial Results as of and for the Second Quarter Ended June 30,
Cash position. As of June 30,
2025, VYNE had $39.6 million of cash, cash equivalents and marketable securities. Based on current operating assumptions, VYNE believes
its cash, cash equivalents and marketable securities as of June 30, 2025 will be sufficient to fund its operations into the first
Share count. As of June 30,
2025, VYNE had 19,773,784 common shares issued and outstanding, and outstanding pre-funded warrants to purchase 23,028,800 shares of common
stock at an exercise price of $0.0001 per share.
Revenues. Revenues totaled $0.1
million and $0.2 million for the quarters ended June 30, 2025 and 2024, respectively, consisting of royalty revenue from the Company's
royalty agreement with LEO Pharma A/S, to whom VYNE previously licensed the rights to Finacea foam.
Research and development expenses.
VYNE's research and development expenses for the three months ended June 30, 2025 were $4.9 million, representing a decrease
of $2.4 million, or 33.2%, compared to $7.3 million for the three months ended June 30, 2024. The decrease was primarily driven by
decreased expenses for repibresib and VYN202 of $2.1 million and $0.2 million, respectively. The $2.1
million decrease in expenses for repibresib was primarily driven by the timing of expenses for the Phase 2b trial in nonsegmental vitiligo,
including a $1.0 million milestone payment due to Tay under the License Agreement upon the initiation of the trial in June 2024. The $0.2
million decrease in expenses for VYN202 was primarily driven by the timing of expenses for Phase 1 trials evaluating VYN202, including
a $1.0 million milestone payment due to Tay under the License Agreement upon the initiation of the Phase 1a healthy volunteer trial in
June 2024, partially offset by increased expenses in the second quarter of 2025 for the Phase 1b trial evaluating VYN202 in moderate-to-severe
plaque psoriasis subjects.
General and administrative expenses. VYNE's
general and administrative expenses for the three months ended June 30, 2025 were $2.7 million, representing a decrease of approximately
$0.6 million, or 17.0%, compared to $3.3 million for the three months ended June 30, 2024. The decrease was primarily driven by a
decrease in employee-related expenses of $0.3 million and consulting and professional fees of $0.2 million.
Net loss. Net loss and net loss
per share for the quarter ended June 30, 2025 was $5.8 million and $0.13, respectively, compared to a net loss and net loss per share
of $9.4 million and $0.22, for the comparable period in 2024.
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.
LifeSci Advisors, LLC
VYNE Therapeutics Inc.
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 the strategic
review, the completion of a strategic transaction and evaluation of VYNE's internal development pipeline, including the continued
clinical development of repibresib and/or VYN202, the clinical hold on the Phase 1b trial of VYN202, including the ability to potentially
fully resolve such hold, VYNE's projected cash runway, and other statements regarding the future expectations, plans and prospects
of VYNE, including the ability of VYNE to find a partner for repibresib. 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, 2024 and Quarterly Report on Form 10-Q for the quarter ended June 30, 2025,
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.
VYNE THERAPEUTICS INC.
CONDENSED CONSOLIDATED BALANCE SHEETS
(U.S. dollars in thousands, except share and per
| June 30, | December 31, | |||||||
| 2025 | 2024 | |||||||
| Assets | ||||||||
| Current Assets: | ||||||||
| Cash and cash equivalents | $ | 22,047 | $ | 19,926 | ||||
| Investment in marketable securities | 17,600 | 41,590 | ||||||
| Prepaid and other current assets | 4,696 | 2,921 | ||||||
| Total Current Assets | 44,343 | 64,437 | ||||||
| Non-current Assets: | ||||||||
| Property and equipment, net | 102 | 113 | ||||||
| Operating lease right-of-use assets | 32 | 93 | ||||||
| Non-current prepaid expenses and other assets | 241 | 2,262 | ||||||
| Total Non-current Assets | 375 | 2,468 | ||||||
| Total Assets | $ | 44,718 | $ | 66,905 | ||||
| Liabilities and Stockholders' Equity | ||||||||
| Current Liabilities: | ||||||||
| Trade payables | $ | 1,414 | $ | 2,707 | ||||
| Accrued expenses | 3,578 | 9,272 | ||||||
| Employee related obligations | 819 | 1,428 | ||||||
| Operating lease liabilities | 25 | 99 | ||||||
| Other current liabilities | - | 1,313 | ||||||
| Total Current Liabilities | 5,836 | 14,819 | ||||||
| Total Liabilities | $ | 5,836 | $ | 14,819 | ||||
| Commitments and Contingencies | ||||||||
| Stockholders' Equity: | ||||||||
| Preferred stock: $0.0001 par value; 20,000,000 shares authorized at June 30, 2025 and December 31, 2024; no shares issued and outstanding at June 30, 2025 and December 31, 2024 | - | - | ||||||
| Common stock: $0.0001 par value; 150,000,000 shares authorized at June 30, 2025 and December 31, 2024; 19,773,784 and 14,830,013 shares issued and outstanding at June 30, 2025 and December 31, 2024, respectively | 2 | 1 | ||||||
| Additional paid-in capital | 784,418 | 783,235 | ||||||
| Accumulated other comprehensive (loss) income | (2 | ) | 20 | |||||
| Accumulated deficit | (745,536 | ) | (731,170 | ) | ||||
| Total Stockholders' Equity | 38,882 | 52,086 | ||||||
| Total Liabilities and Stockholders' Equity | $ | 44,718 | $ | 66,905 |
The accompanying notes are an integral part
of these unaudited condensed consolidated financial statements.
VYNE THERAPEUTICS INC.
CONDENSED CONSOLIDATED STATEMENTS OF OPERATIONS
(U.S. dollars and share data in thousands, except
| Three Months Ended June 30, | Six Months Ended June 30, | |||||||||||||||
| 2025 | 2024 | 2025 | 2024 | |||||||||||||
| Revenues | ||||||||||||||||
| Royalty revenues | $ | 69 | $ | 198 | $ | 271 | $ | 296 | ||||||||
| Total revenues | 69 | 198 | 271 | 296 | ||||||||||||
| Operating expenses: | ||||||||||||||||
| Research and development | 4,881 | 7,306 | 11,004 | 11,014 | ||||||||||||
| General and administrative | 2,730 | 3,288 | 6,005 | 7,058 | ||||||||||||
| Total operating expenses | 7,611 | 10,594 | 17,009 | 18,072 | ||||||||||||
| Operating loss | (7,542 | ) | (10,396 | ) | (16,738 | ) | (17,776 | ) | ||||||||
| Other income, net | 1,795 | 1,001 | 2,388 | 2,140 | ||||||||||||
| Loss from continuing operations before income taxes | (5,747 | ) | (9,395 | ) | (14,350 | ) | (15,636 | ) | ||||||||
| Income tax expense | - | - | - | - | ||||||||||||
| Loss from continuing operations | (5,747 | ) | (9,395 | ) | (14,350 | ) | (15,636 | ) | ||||||||
| Loss from discontinued operations, net of income taxes | (8 | ) | (11 | ) | (16 | ) | (19 | ) | ||||||||
| Net loss | $ | (5,755 | ) | $ | (9,406 | ) | $ | (14,366 | ) | $ | (15,655 | ) | ||||
| Loss per share from continuing operations, basic and diluted | $ | (0.13 | ) | $ | (0.22 | ) | $ | (0.34 | ) | $ | (0.37 | ) | ||||
| Loss per share from discontinued operations, basic and diluted | $ | - | $ | - | $ | - | $ | - | ||||||||
| Loss per share, basic and diluted | $ | (0.13 | ) | $ | (0.22 | ) | $ | (0.34 | ) | $ | (0.37 | ) | ||||
| Weighted average shares outstanding - basic and diluted | 42,759 | 42,586 | 42,716 | 42,584 |
The accompanying notes are an integral part
of these unaudited condensed consolidated financial statements.