Announced positive Phase 1b data for FMX114 in mild-to-moderate atopic dermatitis
Lead
VYNE to host KOL webinar on InhiBETTM
“VYNE made significant progress in the first quarter of 2022 with our pipeline of novel programs for immuno-inflammatory conditions,” said
“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
Pipeline Update
FMX114 - 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.
- In
January 2022 , VYNE announced Phase 1b safety and pharmacology results in which FMX114 demonstrated acceptable pharmacokinetics, evidenced by substantially lower systemic bioavailability of the JAK inhibitor (tofacitinib) and S1P receptor modulator (fingolimod) in the topical formulation compared to oral equivalents. - In
April 2022 , VYNE announced positive efficacy data from the Phase 1b segment in which FMX114 demonstrated a statistically significant reduction in both absolute and percent change in mean Atopic Dermatitis Severity Index (“ADSI”) score compared to vehicle. FMX114 treatment also substantially reduced pruritus (itch) as measured on the worst pruritus Numerical Rating Scale (“NRS”).
VYN201 - VYN201 is a locally-administered pan-bromodomain
- Arthritis Model – VYN201 at each of the 1mg/kg and 10mg/kg doses demonstrated a statistically significant inhibition of inflammation as measured by paw thickness and arthritis score in a validated murine model of rheumatoid arthritis when administered into a single limb via an intra-articular injection, versus untreated limbs. In addition, VYN201 at each of the 1mg/kg and 10mg/kg doses demonstrated numerically superior results compared to an intra-articular injection of the leading steroid, dexamethasone, and results were consistent with systemic dexamethasone treatment, in inhibiting inflammation in arthritic joints of mice.
- Vitiligo Model – VYN201 at each of the 0.1% and 1% concentrations demonstrated a statistically significant improvement in reducing melanocyte loss and lowering MMP-9 and soluble E-cadherin, key inflammatory biomarkers of vitiligo, when compared to vehicle. VYN201 significantly upregulated the WNT signaling pathway (recognized as an important indicator of melanocyte regeneration) with a 10-fold increase at the higher dose (1% concentration). VYN201 0.1% and 1% were also numerically superior to the active control, ruxolitinib cream, 1.5%.
VYN202 - VYN202 is being developed as a highly selective oral
Upcoming KOL Webinar – The Company will host a virtual KOL webinar on VYNE’s InhiBETTM
Select Corporate and Financial Highlights:
- On
January 12, 2022 , VYNE divested its Molecule Stabilizing Technology Franchise ("MST Franchise"), including AMZEEQ, ZILXI, and FCD105, to Journey Medical Corporation ("Journey") for$25 .0 million and milestone payments of up to$450 .0 million in the aggregate upon the achievement of specified levels of net sales on a product-by-product basis, beginning with annual net sales exceeding$100.0 million . Of the$25 .0 million,$20 .0 million was received at closing and$5 .0 million is due to VYNE on the one-year anniversary of the transaction. - In
March 2022 , VYNE entered into a purchase agreement withLincoln Park Capital Fund, LLC (“Lincoln Park”), pursuant to which VYNE has the right, but not the obligation, to sell to Lincoln Park up to$30.0 million of shares of common stock over the 36-month term, subject to terms and conditions set forth in the agreement. Lincoln Park has covenanted not to cause or engage in any manner whatsoever, any direct or indirect short selling or hedging of VYNE’s common stock. A description of the purchase agreement is set forth in the Company's Current Report on Form 8-K, which the Company filed with theSEC onMarch 15, 2022 .
Financial Performance (in thousands) | Three Months Ended | ||||||
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
VYNE currently anticipates that its cash, cash equivalents and restricted cash as of
Financial Results for the First Quarter Ended
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
Revenues. Revenues for the three months ended
VYNE divested the MST Franchise on
Research and development expenses. VYNE's research and development expenses for the three months ended
Selling, general and administrative expenses. VYNE's selling, general and administrative expenses for the three months ended
Net income (loss). Net income for the three months ended
About FMX114
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.
About Bromodomain and Extra-Terminal Domain (BET) Inhibitors
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 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
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 the development of VYNE’s product candidates, the timing of its clinical trials and regulatory filings, its belief that its existing cash, cash equivalents and restricted cash will be sufficient to fund its operations through at least the first quarter of 2023, 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 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 exercise its exclusive option with respect to an oral BETi candidate pursuant to the terms of the option agreement with
CONDENSED CONSOLIDATED BALANCE SHEETS ( (Unaudited) | |||||||
2022 | 2021 | ||||||
Assets | |||||||
Current Assets: | |||||||
Cash and cash equivalents | $ | 50,495 | $ | 42,250 | |||
Restricted cash | 605 | 605 | |||||
Trade receivables, net of allowances | 535 | 7,583 | |||||
Amount due from sale of MST Franchise | 5,000 | — | |||||
Prepaid expenses and other assets | 3,895 | 4,565 | |||||
Operating lease right of use assets | 124 | 338 | |||||
Discontinued operations - current assets | — | 7,845 | |||||
Total Current Assets | 60,654 | 63,186 | |||||
Property and equipment, net | 310 | 354 | |||||
Non-current prepaid expenses and other assets | 3,355 | 3,506 | |||||
Total Assets | $ | 64,319 | $ | 67,046 | |||
Liabilities and stockholders’ equity | |||||||
Current Liabilities: | |||||||
Trade payables | $ | 3,612 | $ | 6,510 | |||
Accrued expenses | 3,312 | 8,593 | |||||
Employee related obligations | 1,331 | 2,752 | |||||
Liability for employee severance benefits | 216 | 206 | |||||
Operating lease liabilities | 117 | 349 | |||||
Total Liabilities | 8,588 | 18,410 | |||||
Commitments and Contingencies | |||||||
Stockholders' Equity: | |||||||
Preferred stock: | — | — | |||||
Common stock: | 6 | 5 | |||||
Additional paid-in capital | 690,580 | 688,156 | |||||
Accumulated deficit | (634,855 | ) | (639,525 | ) | |||
Total Stockholders' Equity | 55,731 | 48,636 | |||||
Total Liabilities and Stockholders’ Equity | $ | 64,319 | $ | 67,046 |
CONDENSED CONSOLIDATED STATEMENTS OF OPERATIONS ( (Unaudited) | |||||||
Three months ended | |||||||
2022 | 2021 | ||||||
Revenues | |||||||
Royalty revenues | $ | 178 | $ | 230 | |||
Total Revenues | 178 | 230 | |||||
Operating expenses: | |||||||
Research and development | 4,452 | 4,255 | |||||
Selling, general and administrative | 4,417 | 5,732 | |||||
Total operating expenses | 8,869 | 9,987 | |||||
Operating loss | (8,691 | ) | (9,757 | ) | |||
Interest expense | — | (1,062 | ) | ||||
Other expense | (3 | ) | (57 | ) | |||
Loss from continuing operations before income taxes | (8,694 | ) | (10,876 | ) | |||
Income tax expense | — | — | |||||
Loss from continuing operations | (8,694 | ) | (10,876 | ) | |||
Income (loss) from discontinued operations, net of income taxes | 13,364 | (9,674 | ) | ||||
Net income (loss) | $ | 4,670 | $ | (20,550 | ) | ||
Loss per share from continuing operations, basic and diluted | $ | (0.16 | ) | $ | (0.22 | ) | |
Income (loss) per share from discontinued operations, basic and diluted | $ | 0.24 | $ | (0.20 | ) | ||
Income (loss) per share basic and diluted | $ | 0.08 | $ | (0.42 | ) | ||
Weighted average shares outstanding, basic and diluted | 55,386 | 48,868 |
Non-GAAP Financial Measures
In evaluating the operating performance of its business, VYNE’s management considers adjusted net income (loss), adjusted net income (loss) per share, adjusted loss from continuing operations, adjusted total operating expenses (including adjusted research and development expense and adjusted selling, general and administrative expense), adjusted operating loss and adjusted loss per share from continuing operations. These non-GAAP financial measures exclude stock-based compensation charges that are required by GAAP. The Company believes that these non-GAAP financial measures provide management, analysts, investors and other users of the Company’s financial information with meaningful supplemental information regarding the performance of the Company’s business by excluding the effect of certain non-cash expenses and items that VYNE believes may not be indicative of its operating performance, because they are either unusual and VYNE does not expect them to recur in the ordinary course of its business, or they are unrelated to the ongoing operation of the business in the ordinary course. These non-GAAP financial measures should not be considered superior to, but rather in addition to, other financial measures prepared by the Company in accordance with GAAP, including the period-to-period results. The Company’s method of determining these non-GAAP financial measures may be different from other companies’ methods and, therefore, may not be comparable to those used by other companies, and the Company does not recommend the sole use of these non-GAAP measures to assess its financial and earnings performance. For reasons noted above, the Company is presenting certain non-GAAP financial measures for the three months ended
The following tables provides detailed reconciliations of various other income statement data between GAAP and non-GAAP amounts for the three months ended
Reconciliation of net income (loss) to adjusted net income (loss) and net income (loss) per share to adjusted net income (loss) per share:
Three months ended | |||||
2022 | 2021 | ||||
Net income (loss) (GAAP) | $ | 4,670 | $ | (20,550 | ) |
Add-back: stock-based compensation expense | 893 | 2,442 | |||
Adjusted net income (loss) (non-GAAP) | $ | 5,563 | $ | (18,108 | ) |
Net income (loss) per share, basic and diluted (GAAP) | $ | 0.08 | $ | (0.42 | ) |
Add-back: stock-based compensation expense | 0.02 | 0.05 | |||
Adjusted net income (loss) per share, basic and diluted (non-GAAP) | $ | 0.10 | $ | (0.37 | ) |
Weighted average number of shares outstanding, basic and diluted | 55,386 | 48,868 |
Reconciliation of loss from continuing operations to adjusted loss from continuing operations; research and development expense to adjusted research and development expense; selling, general and administrative expense to adjusted selling, general and administrative expense; total operating expense to adjusted total operating expense; operating loss to adjusted operating loss; and loss per share from continuing operations to adjusted loss per share from continuing operations:
Three months ended | ||||||
2022 | 2021 | |||||
Loss from continuing operations (GAAP) | $ | (8,694 | ) | $ | (10,876 | ) |
Add-back: stock-based compensation expense | 1,245 | 2,060 | ||||
Adjusted loss from continuing operations (non-GAAP) | $ | (7,449 | ) | $ | (8,816 | ) |
Research and development expense (GAAP) | $ | 4,452 | $ | 4,255 | ||
Less: stock-based compensation expense | (229 | ) | (458 | ) | ||
Adjusted research and development expense (non-GAAP) | $ | 4,223 | $ | 3,797 | ||
Selling, general and administrative expense (GAAP) | $ | 4,417 | $ | 5,732 | ||
Less: stock-based compensation expense | (1,016 | ) | (1,602 | ) | ||
Adjusted selling, general and administrative expense (non-GAAP) | $ | 3,401 | $ | 4,130 | ||
Total operating expenses (GAAP) | $ | 8,869 | $ | 9,987 | ||
Less: stock-based compensation expense | (1,245 | ) | (2,060 | ) | ||
Adjusted total operating expenses (non-GAAP) | $ | 7,624 | $ | 7,927 | ||
Operating loss (GAAP) | $ | (8,691 | ) | $ | (9,757 | ) |
Add back: stock-based compensation expense | 1,245 | 2,060 | ||||
Adjusted operating loss (non-GAAP) | $ | (7,446 | ) | $ | (7,697 | ) |
Loss per share from continuing operations, basic and diluted (GAAP) | $ | (0.16 | ) | $ | (0.22 | ) |
Add back: stock-based compensation expense | 0.02 | 0.04 | ||||
Adjusted loss per share from continuing operations, basic and diluted (non-GAAP) | $ | (0.14 | ) | $ | (0.18 | ) |
Weighted average number of shares outstanding - basic and diluted | 55,386 | 48,868 |
Source:
2022 GlobeNewswire, Inc., source