- 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
“During the first quarter, we made steady progress in advancing our VYN201 program toward a Phase 2b trial,” said
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
- 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 onMay 15-18, 2024 inDallas, Texas .
Financial Results as of and for the First Quarter Ended
Cash position. As of
Revenues. Revenues totaled
Research and development expenses. VYNE’s research and development expenses for the quarter ended
General and administrative expenses. VYNE’s general and administrative expenses for the quarter ended
Net loss. Net loss and net loss per share for the quarter ended
About
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
For more information about
Investor Relations:
917-355-2395
jfraunces@lifesciadvisors.com
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
CONDENSED CONSOLIDATED BALANCE SHEETS ( (Unaudited) | |||||||
2024 | 2023 | ||||||
Assets | |||||||
Current Assets: | |||||||
Cash and cash equivalents | $ | 19,065 | $ | 30,620 | |||
Restricted cash | 54 | 54 | |||||
Investment in marketable securities | 66,885 | 62,633 | |||||
Prepaid and other expenses | 4,219 | 2,656 | |||||
Total Current Assets | 90,223 | 95,963 | |||||
Non-current Assets: | |||||||
Operating lease right-of-use assets | 180 | 207 | |||||
Non-current prepaid expenses and other assets | 1,273 | 1,515 | |||||
Total Non-current Assets | 1,453 | 1,722 | |||||
Total Assets | $ | 91,676 | $ | 97,685 | |||
Liabilities and Stockholders’ Equity | |||||||
Current Liabilities: | |||||||
Trade payables | $ | 2,795 | $ | 1,659 | |||
Accrued expenses | 3,642 | 4,119 | |||||
Employee related obligations | 376 | 1,645 | |||||
Operating lease liabilities | 117 | 115 | |||||
Total Current Liabilities | 6,930 | 7,538 | |||||
Long-term Liabilities: | |||||||
Non-current operating lease liabilities | 63 | 99 | |||||
Other liabilities | 1,313 | 1,313 | |||||
Total Long-term Liabilities | 1,376 | 1,412 | |||||
Total Liabilities | 8,306 | 8,950 | |||||
Commitments and Contingencies | |||||||
Stockholders' Equity: | |||||||
Preferred stock: | — | — | |||||
Common stock: | 1 | 1 | |||||
Additional paid-in capital | 781,024 | 780,044 | |||||
Accumulated other comprehensive (loss) income | (70 | ) | 26 | ||||
Accumulated deficit | (697,585 | ) | (691,336 | ) | |||
Total Stockholders' Equity | 83,370 | 88,735 | |||||
Total Liabilities and Stockholders’ Equity | $ | 91,676 | $ | 97,685 | |||
CONDENSED CONSOLIDATED STATEMENTS OF OPERATIONS ( (Unaudited) | |||||||
Three Months Ended | |||||||
2024 | 2023 | ||||||
Revenues | |||||||
Royalty revenues | $ | 98 | $ | 99 | |||
Total Revenues | 98 | 99 | |||||
Operating Expenses: | |||||||
Research and development | 3,708 | 2,734 | |||||
General and administrative | 3,770 | 3,240 | |||||
Total Operating Expenses | 7,478 | 5,974 | |||||
Operating Loss | (7,380 | ) | (5,875 | ) | |||
Other income, net | 1,139 | 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 diluted | 42,581 | 3,255 |
Source:
2024 GlobeNewswire, Inc., source