Full Press Release Details
VYNE Therapeutics Reports Third Quarter 2023
Financial Results and Provides Business Update
Transformative capital
raise of $88.2 million from leading healthcare investors provides funding for BET inhibitor programs through the end of 2025
Phase 2b preparatory activities progressing
for VYN201 in nonsegmental vitiligo following positive Phase 1b results
On track for VYN202 IND submission by year-end
2023, with plans to begin Phase 1a trial in Q1 2024
BRIDGEWATER, N.J., November 13, 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 nine months ended September 30, 2023 and provided a business update.
"We have made substantial progress in advancing
our business in recent months," said David Domzalski, President and Chief Executive Officer of VYNE. "With positive results
from our Phase 1b trial, we believe there is strong support to advance VYN201 as a potential category-leading therapy in the treatment
of vitiligo. In addition, we remain on track to submit our IND for VYN202 by the end of this year, with plans to initiate a Phase 1a single
ascending dose/multiple ascending dose trial in the first quarter of 2024. Upon successful completion of the Phase 1a trial, we plan to
initiate Phase 1b proof-of-concept trials in moderate-to-severe plaque psoriasis and in moderate-to-severe adult-onset rheumatoid arthritis
in the second half of 2024."
"Our completion of an $88.2 million capital
raise from premier healthcare investors significantly strengthens our balance sheet and we believe highlights the enthusiasm for our InhiBET
platform," continued Mr. Domzalski. "By extending our cash runway through the end of 2025, we can focus on executing our
strategy of validating BET inhibition as a treatment for immuno-inflammatory conditions and delivering on key value-creating milestones."
Recent Corporate Update
$88.2 million private placement with leading
fundamental healthcare investors, extended cash runway through the end of 2025. On November 1, 2023, the Company completed a
private placement financing (the "PIPE") resulting in gross proceeds to the Company of $88.2 million, before deducting placement
agent fees and offering expenses, from the sale of 10,652,543 shares of common stock at a purchase price of $2.245 per share and, in lieu
of common stock to certain investors, pre-funded warrants to purchase up to an aggregate of 28,614,437 shares of common stock at a purchase
price of $2.2449 per pre-funded warrant. The net proceeds from the offering are expected to be used to fund the advancement of VYN201
into a Phase 2b clinical trial in vitiligo and Phase 1 trials for VYN202.
Recent Pipeline Updates
VYN201, a locally-administered pan-BD BET inhibitor:
VYN202, an oral small molecule BD2-selective BET inhibitor:
| Financial Performance | Three Months Ended September 30 | Nine Months Ended September 30 | ||||||||||||||
| (in thousands) | 2023 | 2022 | 2023 | 2022 | ||||||||||||
| Loss from continuing operations (GAAP) | $ | (6,071 | ) | $ | (9,255 | ) | $ | (21,720 | ) | $ | (26,184 | ) | ||||
| Adjusted loss from continuing operations (non-GAAP)* | $ | (5,208 | ) | $ | (8,081 | ) | $ | (19,125 | ) | $ | (22,602 | ) | ||||
| Net loss (GAAP) | $ | (6,584 | ) | $ | (9,459 | ) | $ | (22,264 | ) | $ | (13,265 | ) | ||||
| Adjusted net loss (non-GAAP)* | $ | (5,721 | ) | $ | (8,285 | ) | $ | (19,669 | ) | $ | (10,035 | ) |
*See "Non-GAAP Financial Measures" elsewhere in this earnings
Liquidity and Capital Resources
As of September 30, 2023, VYNE had cash and
cash equivalents and restricted cash of $15.5 million. When adding the gross proceeds received from the PIPE, VYNE's cash and cash equivalents
and restricted cash as of September 30, 2023 would have been approximately $103.7 million. VYNE currently anticipates that its cash
and cash equivalents and restricted cash as of September 30, 2023, together with the gross proceeds from the PIPE, 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 for the quarter ended September 30, 2023 for additional discussion on
liquidity and capital resources.
Financial Results for the Third Quarter Ended September 30,
Revenues. Revenues for the quarter
ended September 30, 2023 totaled $0.1 million compared to $0.2 million for the quarter ended September 30, 2022, consisting
Research and development expenses.
VYNE's research and development expenses for the quarter ended September 30, 2023 were $3.3 million, as compared to $5.5 million
for the comparable period in 2022. The decrease was primarily driven by decreased spend for FMX114
and VYN201 and lower employee-related expenses. The decrease was partially offset by increased
Selling, general and administrative expenses.
VYNE's selling, general and administrative expenses for the quarter ended September 30, 2023 were $3.0 million, compared
to $4.0 million for the comparable period in 2022. The decrease was primarily driven by decreased consulting and professional fees and
lower corporate insurance expenses.
Net loss. Net loss and net loss
per share for the quarter ended September 30, 2023 was $6.6 million and $2.01, respectively, compared to a net loss and net loss
per share of $9.5 million and $2.94 for the comparable period in 2022, respectively. Net loss reported for the third quarter of 2023 reflected
the impact of $0.5 million from discontinued operations, net of income taxes. The third 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-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.
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
VYNE's plans, regulatory filings and development timelines for VYN201 and VYN202, VYNE's InhiBET platform,
VYNE's projected cash runway through the end of 2025, 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 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 September 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.