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VYNE Therapeutics Reports First Quarter 2022 Financial Results and Provides Business Update Announced positive Phase 1b data for FMX114 in mild-to-moderate atopic dermatitis Lead BET inhibitor VYN201 demonstrated positiv

Key Takeaway: VYNE Therapeutics Reports First Quarter 2022 Financial Results and Provides Business Update Announced positive Phase 1b data for FMX114 in mild-to-moderate atopic dermatitis Lead BET inhibitor VYN201 demonstrated positive results across multiple preclinical models of inflamm

Full Press Release Details

VYNE Therapeutics Reports First Quarter 2022
Financial Results and Provides Business Update
Announced positive Phase 1b data for FMX114
in mild-to-moderate atopic dermatitis
Lead BET inhibitor VYN201 demonstrated positive
results across multiple preclinical models of inflammation
VYNE to host KOL webinar on InhiBETTM
BET inhibitor platform on May 17th
BRIDGEWATER, N.J., May 12, 2022 -- VYNE Therapeutics Inc. (Nasdaq:
VYNE) ("VYNE" or the "Company"), a biopharmaceutical company developing proprietary, innovative, and differentiated
therapies for the treatment of immuno-inflammatory conditions, today announced financial results for the quarter ended March 31,
2022 and provided a business update.
"VYNE made significant progress in the
first quarter of 2022 with our pipeline of novel programs for immuno-inflammatory conditions," said David Domzalski, Chief Executive
Officer of VYNE. "We reported positive Phase 1b safety and efficacy data for FMX114 in mild-to-moderate atopic dermatitis, released
promising preclinical data for our locally-administered pan-BD BET inhibitor, VYN201, and completed the divestiture of our topical minocycline
"Looking ahead, we plan to report Phase 2a safety and efficacy
results for FMX114 by the end of the second quarter. We are pleased with our toxicology and scale-up activities for VYN201 and remain
on schedule to initiate our first in-human clinical study for our lead indication in the second half of this year. In addition, we continue
to work with our partner In4Derm on final candidate selection for VYN202," continued Mr. Domzalski. "We look forward to providing
updates to investors throughout the year as we advance our pipeline of proprietary immuno-inflammatory therapeutics."
- FMX114 is VYNE's proprietary investigational combination gel formulation of tofacitinib and fingolimod that is designed
to address both the source and cause of inflammation in mild-to-moderate atopic dermatitis ("AD"). FMX114 has the potential
to be the first topical combination product for the treatment of AD. FMX114 is currently being evaluated in a Phase 2a study with topline
results expected by the end of the second quarter. VYNE previously conducted a Phase 1b study (n=4) to evaluate the preliminary clinical
safety, dermal tolerance and pharmacokinetics of FMX114 and vehicle when topically applied to individual qualifying AD lesions for 2
weeks. Efficacy was also assessed over the two-week treatment period.
- VYN201 is a locally-administered pan-bromodomain BET inhibitor, designed as a "soft" drug to address diseases
involving multiple, diverse inflammatory cell signaling pathways while providing low systemic exposure. VYNE intends to select the first
clinical indication for VYN201 in the second quarter 2022 based on the results from several well-established preclinical models across
a range of potential immuno-inflammatory therapeutic areas. To date, VYN201 has demonstrated significant improvement in inflammation
and fibrosis scores and reduction of inflammatory biomarker levels, while maintaining good tolerability in animals. The Company believes
that these data suggest potential broad utility for VYN201. Recently released data includes:
- VYN202 is being developed as a highly selective oral BET inhibitor designed to selectively bind to bromodomain 2 for the
potential treatment of major immuno-inflammatory diseases. VYNE is working with its license partner, In4Derm Limited, to develop
and select a lead candidate. Following candidate selection, VYNE intends to exercise its option for this molecule and initiate IND-enabling
KOL Webinar - The Company will host a virtual KOL webinar on VYNE's InhiBETTM BET inhibitor platform
on May 17, 2022 at 10:00AM ET. The webinar will feature a presentation from Gerald V. Denis, PhD (Boston University School of Medicine)
and Thierry Passeron, MD, PhD (University Hospital of Nice (France)). Dr. Denis will provide a background on BET inhibition for
the treatment of various immuno-inflammatory conditions, and Dr. Passeron will then discuss the current treatment landscape and
unmet medical need in treating patients with vitiligo. The VYNE leadership team will present preclinical data for VYN201 as well as provide
a company update and an overview of future milestones. A live question and answer will follow. Registration for this event is available
through the following link: KOL Webinar Registration Link
Select Corporate and Financial Highlights:
Financial Performance Three Months Ended March 31,
(in thousands) 2022 2021
Loss from continuing operations (GAAP) $ (8,694 ) $ (10,876 )
Adjusted loss from continuing operations (non-GAAP)* $ (7,449 ) $ (8,816 )
Net income (loss) (GAAP) $ 4,670 $ (20,550 )
Adjusted net income (loss) (non-GAAP)* $ 5,563 $ (18,108 )
*See "Note Regarding the Use of Non-GAAP Financial Measures"
elsewhere in this earnings release.
Liquidity and Capital Resources
As of March 31, 2022, VYNE had cash, cash equivalents and restricted
cash of $51.1 million. Additionally, VYNE is entitled to receive a $5.0 million payment in January 2023 from Journey in connection
with the sale of the MST Franchise.
VYNE currently anticipates that its cash, cash equivalents and restricted
cash as of March 31, 2022 will be sufficient to fund its operations through at least the first quarter of 2023, without giving effect
to any potential business development transactions or financing activities, including from the purchase agreement with Lincoln Park.
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 March 31, 2022 for additional discussion on liquidity.
Financial Results for the First Quarter Ended March 31, 2022
Due to the sale of the MST Franchise during the first quarter of
2022, the Company has classified the results of the MST Franchise as discontinued operations in its unaudited condensed consolidated
statements of operations for all periods presented. See Note 3 to VYNE's unaudited interim condensed consolidated financial statements
included in VYNE's Quarterly Report on Form 10-Q for the quarter ended March 31, 2022 for additional discussion on discontinued
Revenues for the three months ended March 31, 2022 remained consistent at $0.2 million when compared to the
three months ended March 31, 2021. Revenues were comprised of royalty revenue for both periods.
VYNE divested the MST Franchise on January 12,
2022. As a result of the sale, the Company will not generate revenue from the sales of AMZEEQ or ZILXI following such date.
and development expenses. VYNE's research and development expenses for the three months ended March 31, 2022 were
$4.5 million compared to $4.3 million for the three months ended March 31, 2021, representing an increase of $0.2 million, or 4.6%.
The increase is primarily related to an increase in expenses associated with development of VYN201 of approximately $1.7 million,
partially offset by a decrease in personnel costs of $0.7 million and a decrease in expenses for FMX114 of $0.6 million.
general and administrative expenses. VYNE's selling, general and administrative expenses for the three months ended March 31,
2022 were $4.4 million compared to $5.7 million for the three months ended March 31, 2021, representing a decrease of $1.3 million,
or 22.9%. Employee-related expenses decreased by $0.8 million primarily due to lower headcount in 2022. The balance of the decrease
was due to lower professional fees.
income (loss). Net income for the three months ended March 31, 2022 was $4.7 million compared to a net loss
of $20.6 million for the three months ended March 31, 2021. Loss from continuing operations was $8.7 million for the three
months ended March 31, 2022 compared to $10.9 million for the prior year period. Income from discontinued operations was $13.4 million
for three months ended March 31, 2022 compared to a loss from discontinued operations of $9.7 million for the three months
ended March 31, 2021.
FMX114 is VYNE's proprietary investigational
combination gel formulation of tofacitinib and fingolimod. The product is designed to address both the source and cause of inflammation
in AD through a combination of tofacitinib (a Janus kinase inhibitor) that acts with cells to reduce inflammation by inhibiting cytokine
release from inflammatory cells) and fingolimod (a Sphingosine 1-phosphate receptor modulator) that acts outside of cells to reduce inflammation
by inhibiting migration of inflammatory cells. In addition, fingolimod may also directly support skin barrier recovery because it is
known to upregulate filaggrin, a protein that plays an important role in the skin's barrier function. FMX114 has the potential
to be the first topical combination product for the treatment of AD as well as the first topical product in clinical development that
utilizes the sphingosine 1-phosphate receptor modulation mode of action.
and Extra-Terminal Domain (BET) Inhibitors
BET proteins play a key role in regulating gene
transcription via epigenetic interactions ("reading"), and recent research has determined a key role for these BET proteins
in regulating B cell and T cell activation and subsequent inflammatory processes. As epigenetic readers, BET proteins regulate the recruitment
of transcriptional factors that are key to the production of several pro-inflammatory cytokines. Inhibiting BET proteins blocks cytokine
transcription, and therefore may have significant therapeutic potential across a wide variety of immuno-inflammatory/fibrotic and myeloproliferative
neoplastic disorders. A locally administered pan-BET inhibitor has the possibility to positively impact diseases involving multiple,
diverse inflammatory cell signaling pathways that are active in many immune-inflammatory diseases.
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 pipeline includes FMX114 for the potential treatment of mild-to-moderate atopic dermatitis, and
access to a library of bromodomain & extra-terminal (BET) domain inhibitors licensed from In4Derm Limited. The BET inhibitor
platform includes lead programs VYN201 (pan-BETi) and VYN202 (selective-BETi) and access to a library of (BET) domain inhibitors for
Last updated: May 12, 2022