Full Press Release Details
VYNE Therapeutics Reports Year-End 2021 Financial
Results and Provides Corporate Update
FMX114 demonstrated preliminary clinical
safety and pharmacokinetics in Phase 1b study
VYN201 shows promising preclinical data in
3 well-established and validated inflammation models
BRIDGEWATER, N.J., March 17, 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
fourth quarter and year ended December 31, 2021 and provided a business update.
"2021 was a transformative year for VYNE,
we have made significant progress on our strategic focus to develop novel therapies for immuno-inflammatory conditions, leveraging our
core drug development competencies. We completed the divestiture of our topical minocycline MST franchise in January, reported positive
Phase 1b safety data for FMX114 and released a series of promising preclinical data for our InhiBETTM inhibitor platform,"
said David Domzalski, CEO of VYNE.
"We have several important milestones slated
throughout the remainder of 2022 for our three novel immuno-inflammatory pipeline programs, FMX114, VYN201 and VYN202," continued
Mr. Domzalski. "We plan to report Phase 2a safety and efficacy results in the second quarter. Next, we plan to initiate our
first in-human clinical study for VYN201 in the second half of this year, followed by exercising of the option and an IND filing for VYN202.
We look forward to updating shareholders on our progress throughout the year."
FMX114 - FMX114 is a topical, non-steroidal
investigational therapy, and if approved, is believed to be the first topical combination drug for the treatment of mild-to-moderate atopic
dermatitis ("AD"). FMX114 combines the JAK inhibitor, tofacitinib, with the Sphingosine-1 receptor modulator, fingolimod,
with the intent of taking a multi-targeted approach to address inflammation in the skin while minimizing systemic exposure.
VYNE has reported the results of preclinical studies
and Phase 1b safety and pharmacology data. These data support VYNE's product design objectives for FMX114.
VYN201 - 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 is evaluating VYN201 in several well-established
preclinical models across a range of potential immuno-inflammatory therapeutic areas. To date, VYN201 has demonstrated significant improvement
in inflammation scores and reduction in inflammatory biomarker levels, while maintaining good tolerability in animals. We believe that
these data outlined below suggest potential broad utility for VYN201.
VYN202 - VYN202 is a highly selective oral
BET inhibitor designed to selectively bind to bromodomain 2 ("BD2") and is being developed 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 studies.
Upcoming Anticipated Milestones:
Select Corporate and Financial Highlights:
| (In thousands, except per share amounts) | Three months ended December 31 | Year ended December 31 | ||||||||||||||
| 2021 | 2020 | 2021 | 2020 | |||||||||||||
| Total Revenues | $ | 2,292 | $ | 4,286 | $ | 14,755 | $ | 20,993 | ||||||||
| Net Loss | $ | (11,570 | ) | $ | (23,181 | ) | $ | (73,329 | ) | $ | (255,568 | ) | ||||
| Basic and diluted Net Loss per Share | $ | (0.22 | ) | $ | (0.55 | ) | $ | (1.42 | ) | $ | (7.88 | ) | ||||
| Adjusted Net Loss* | $ | (10,145 | ) | $ | (18,127 | ) | $ | (65,156 | ) | $ | (96,296 | ) | ||||
| Adjusted basic and diluted Net Loss per Share* | $ | (0.20 | ) | $ | (0.43 | ) | $ | (1.26 | ) | $ | (2.97 | ) |
* See "Note Regarding the Use of Non-GAAP Financial Measures"
elsewhere in this earnings release.
Cash and Cash Equivalents
Financial Results for the Year Ended December 31, 2021
Revenues. Revenues for the year
ended December 31, 2021 were $14.8 million as compared to $21.0 million for the comparable period in 2020.
For the year ended December 31, 2021, revenue
consisted of $13.8 million of product sales and $0.9 million of royalty revenue. For the year ended December 31, 2020, revenues consisted
of $10.2 million of product sales, $10.0 million of license revenue, and $0.8 million of royalty revenue.
Revenue in both periods was primarily attributable
to the MST franchise which the Company divested in January 2022.
Cost of Goods Sold. Cost of goods
sold was $3.3 million for the year ended December 31, 2021 compared to $1.4 million for the comparable period in 2020. The increase
in cost of goods sold was related to the MST franchise, which the Company divested in January 2022.
Research and Development Expenses. Research
and development expenses for the year ended December 31, 2021 were $25.0 million as compared to $43.5 million for the comparable
period in 2020. The decrease was primarily associated with a reduction in employee related expenses and a focus on earlier-stage development
programs, which lowered clinical trial and manufacturing costs in 2021.
Selling, General and Administrative Expenses.
Selling, general and administrative expenses for the year ended December 31, 2021 were $54.5 million compared to $89.5
million for the comparable period in 2020. The decrease was driven by higher employee, corporate and professional costs incurred in 2020
following the merger of Foamix Pharmaceuticals Ltd. and Menlo Therapeutics Inc. (the "Merger") in March 2020, which were
eliminated or reduced in 2021. The decrease in employee related expenses in 2021 was also due to a reduction in workforce resulting from
the decision to sell the MST franchise.
Goodwill and in-process research and development
impairments. During 2020, the Company recorded goodwill and in-process research & development impairments of $54.3 million
due to the failed clinical trials for serlopitant for the treatment of pruritus associated with prurigo nodularis. No impairments were
recorded in the year ended December 31, 2021.
Contingent Stock Right Remeasurement. In
connection with the Merger, the Company entered into a contingent stock right agreement that called for the issuance of additional shares
of the Company's common stock to legacy Foamix shareholders upon negative data from the Phase 3 prurigo nodularis trials. Since
the trials did not meet the milestones outlined per the agreement, the contingent stock rights were remeasured, resulting in an expense
of $84.7 million in the year ended December 31, 2020. No such expense occurred in the year ended December 31, 2021.
Net loss/Net loss per share. The
Net loss and Net loss per share for the year ended December 31, 2021 was $73.3 million and $1.42 compared to $255.6 million
and $7.88 for the comparable period in 2020.
VYNE's proprietary investigational combination gel formulation of tofacitinib and fingolimod. The product is being developed to
address both the source and cause of inflammation in AD by developing a distinct 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 recover by upregulating filaggrin. 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.
About Bromodomain and Extra-Terminal Domain
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 the
potential treatment of immuno-inflammatory conditions.
For more information about VYNE Therapeutics Inc.
or its investigational products, visit www.vynetherapeutics.com. VYNE may use its website to comply with