VYNE Reports 2023 Fourth Quarter and Year-End Financial Results and Provides Business Update
VYNE Therapeutics Inc. had a transformative year in 2023, achieving clinical proof-of-concept for VYN201 in vitiligo and securing funding. The company ended 2023 with $93.3 million in cash, providing runway through 2025. Plans include a Phase 2b trial for VYN201 and a Phase 1a trial for VYN202 in Q2 2024.
Positive
Successful achievement of clinical proof-of-concept for VYN201 in vitiligo.
Secured funding with leading institutional investors, ending 2023 with $93.3 million in cash.
Plan to commence a Phase 2b trial for VYN201 and a Phase 1a trial for VYN202 in Q2 2024.
Positive progress with VYN201 program and submission of supplemental nonclinical information to the FDA for VYN202.
Financial results showed revenues of $0.4 million for 2023, with research and development expenses of $16.3 million and general and administrative expenses of $13.4 million.
Net loss for 2023 was $28.5 million, compared to $23.2 million in 2022.
The financial results reported by VYNE Therapeutics Inc. indicate a strategic positioning for the company with a strong cash reserve of $93.3 million , which is expected to provide a runway through the end of 2025. This financial stability is crucial as it supports the company's upcoming clinical trials, including the Phase 2b trial for VYN201 and the Phase 1a trial for VYN202. The decrease in net loss from $33.9 million in 2022 to $27.9 million in 2023 reflects a tighter control on expenses and a more focused R&D expenditure.
From an investor's perspective, the reported reduction in R&D expenses, despite the progression to more advanced clinical trials, may suggest improved operational efficiency. However, the decrease in revenue from $0.5 million in 2022 to $0.4 million in 2023 warrants attention, as it could indicate challenges in royalty income or product market performance. The increase in net loss per share from $7.28 to $2.78, despite a lower net loss, likely results from a change in the number of shares outstanding, which investors should review for potential dilution effects.
The progression of VYNE's clinical pipeline is significant for the company's future prospects. The successful completion of the Phase 1b trial and the transition into a Phase 2b trial for VYN201 , a topically administered therapy for vitiligo, represents a critical step towards addressing an unmet medical need. The positive biomarker data from the Phase 1b trial supports the therapeutic's potential efficacy.
Furthermore, the engagement with an experienced CRO to manage the upcoming trials for both VYN201 and VYN202 is a strategic move to ensure trial efficiency and compliance with regulatory standards. The anticipation of Phase 1a trial results for VYN202 in the second half of 2024 is a pivotal event that could significantly impact the company's valuation, as successful results could lead to further development in indications like psoriasis and rheumatoid arthritis, which are large markets with substantial patient populations.
The clinical development updates for VYNE's product candidates VYN201 and VYN202 are likely to influence the company's market positioning within the immuno-inflammatory treatment landscape. The selection of a gel formulation for VYN201, based on its improved dermal penetration properties, may offer competitive advantages in terms of efficacy and patient adherence. The market for vitiligo treatments is evolving and VYNE's approach could differentiate it from existing therapies if clinical outcomes are favorable.
For VYN202, the initiation of a Phase 1a trial in healthy volunteers signals the company's expansion into oral small molecule BET inhibitors, a space that has garnered interest for its potential in addressing various inflammatory conditions. The careful orchestration of trial activities, including the engagement of a CRO and the manufacturing of capsules, suggests that VYNE is strategically preparing for a seamless trial process, which is crucial for maintaining investor confidence and meeting clinical milestones that can drive stock performance.
02/29/2024 - 08:00 AM
2023 was a transformative year for VYNE, marked by the achievement of clinical proof-of-concept for VYN201 in vitiligo and a successful financing with a syndicate of leading institutional investors Anticipate commencing a Phase 2b trial for VYN201 and a Phase 1a trial for VYN202 in Q2 2024 Ended 2023 with $93.3 million of cash, cash equivalents, restricted cash and marketable securities, providing runway through the end of 2025 and multiple expected clinical milestones BRIDGEWATER, N.J., Feb. 29, 2024 (GLOBE NEWSWIRE) -- 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 fourth quarter and year ended December 31, 2023 and provided a business update.
“We have entered 2024 with positive momentum, following an exciting year highlighted by our clinical proof-of-concept data for VYN201 and a successful financing with leading healthcare institutional investors,” said David Domzalski, President and CEO of VYNE. “We have made excellent progress with our VYN201 program and remain on track to initiate a Phase 2b trial in nonsegmental vitiligo next quarter. In addition, we expect to submit supplemental nonclinical information to the FDA in the coming weeks in support of our IND for VYN202, and assuming clearance by the FDA, we expect to commence our Phase 1a SAD/MAD trial next quarter as well. We look forward to providing updates on our programs over the coming months."
Recent Pipeline Updates
VYN201, a locally-administered pan-BD BET inhibitor:
Selected formulation for Phase 2b trial – Following extensive testing, VYNE plans to evaluate VYN201 in a once-daily gel formulation for the upcoming Phase 2b trial in patients with nonsegmental vitiligo. The Company believes the gel formulation may provide additional clinical benefits based on improved dermal penetration properties compared to the ointment that was evaluated in the Phase 1b trial.Engaged experienced contract research organization (“CRO”) – VYNE has engaged a CRO with extensive experience conducting Phase 2 and Phase 3 vitiligo trials for its upcoming Phase 2b trial. Trial startup activities are ongoing with patient enrollment expected to begin in the second quarter of 2024. Top line results from the 24-week double-blind portion of the Phase 2b trial are anticipated in mid-2025.Submitted Phase 2b trial design to FDA – The Phase 2b trial is anticipated to be a 24-week randomized, double-blind, vehicle-controlled trial with a separate active treatment extension phase to 52 weeks. Pending the U.S. Food and Drug Administration's (“FDA”) acceptance of the protocol, the trial will evaluate three or four arms (including vehicle) of once-daily treatment with VYN201 gel, with each arm enrolling between 40 and 50 patients with active or stable nonsegmental vitiligo. The primary efficacy endpoint of the trial will be an evaluation of the proportion of subjects achieving FVASI50 at week 24 compared to vehicle.Announced positive biomarker data from Phase 1b trial – Earlier this year, VYNE announced that exploratory data for the 1.0% and 2.0% cohorts from the Phase 1b trial showed that VYN201 treatment demonstrated biological activity and a positive effect on certain key biomarkers relevant to vitiligo disease severity and progression. This data supports VYN201’s rapid onset of action and previously announced positive clinical results.VYN202, an oral small molecule BD2-selective BET inhibitor:
Completed additional nonclinical study in support of IND – VYNE submitted an Investigational New Drug application ("IND") for VYN202 to the FDA in December 2023. Before commencing a Phase 1a clinical trial, the FDA requested data from an additional nonclinical study. VYNE recently completed this study and achieved preliminary results consistent with its expectations at the outset of the study. This additional study evaluated doses of VYN202 within the expected clinical therapeutic window of the BET target. Consistent with previous nonclinical studies for VYN202, there were no apparent off-target toxicities observed. VYNE plans to submit the requested nonclinical information to the FDA by the end of the first quarter of 2024.Phase 1a trial expected to start in Q2 – Assuming the IND is cleared by the FDA, VYNE expects to initiate its Phase 1a single ascending dose/multiple ascending dose (SAD/MAD) trial in healthy volunteers in the second quarter of 2024, with top line results from the trial anticipated in the second half of 2024. If the Phase 1a portion of the 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.Trial startup activities substantially complete – VYNE has engaged a CRO for its Phase 1a trial and has completed the manufacturing of VYN202 capsules.Upcoming Congress and Conference Participation
Global Vitiligo Foundation Annual Scientific Symposium – Dr. Iain Stuart, Chief Scientific Officer of VYNE, will present data from the Phase 1b trial for VYN201 in nonsegmental vitiligo at the Foundation’s annual symposium held on March 7, 2024 in San Diego.Investor Conferences – VYNE will be participating in the upcoming TD Cowen 44th Annual Health Care Conference, taking place in Boston on March 4-6, 2024, as well as the H.C. Wainwright 2nd Annual Autoimmune and Inflammatory Disease Conference being held virtually on March 28, 2024.Financial Performance (in thousands) Three months ended December 31, Year ended December 31, 2023 2022 2023 2022 Loss from continuing operations (GAAP) $ (6,152 ) $ (7,761 ) $ (27,872 ) $ (33,945 ) Adjusted loss from continuing operations (non-GAAP)* $ (5,442 ) $ (6,694 ) $ (24,567 ) $ (29,296 ) Net loss (GAAP) $ (6,188 ) $ (9,945 ) $ (28,452 ) $ (23,210 ) Adjusted net loss (non-GAAP)* $ (5,478 ) $ (8,878 ) $ (25,147 ) $ (18,913 )
*See “Non-GAAP Financial Measures” elsewhere in this earnings release.
As of December 31, 2023, VYNE had cash, cash equivalents, restricted cash and marketable securities of $93.3 million . VYNE believes its cash, cash equivalents, restricted cash and marketable securities as of December 31, 2023 will be sufficient to fund its operations through the end of 2025. See Note 1 to VYNE’s audited consolidated financial statements included in VYNE’s Annual Report on Form 10-K for additional discussion on liquidity and capital resources.
Financial Results for the Year Ended December 31, 2023
Revenues. $0.4 million compared to $0.5 million for the year ended December 31, 2022, consisting of royalty revenue from sales of Finacea foam by LEO Pharma, to whom VYNE previously licensed the rights to that product.
Research and development expenses $16.3 million , representing a decrease of $2.1 million , or 11.3% , as compared to $18.4 million for the year ended December 31, 2022. The decrease was primarily due to lower employee-related expenses of $3.8 million and decreased spending for FMX114 and VYN201 of $2.7 million and $2.2 million , respectively. The decrease was partially offset by increased expenses for VYN202 of $6.7 million , including $4.0 million paid in connection with entering into a license agreement with Tay Therapeutics for VYN202.
General and administrative expenses. $13.4 million , representing a decrease of $3.0 million , or 18.4% , compared to $16.4 million for the year ended December 31, 2022. The decrease was primarily driven by lower rent and corporate insurance costs of $1.6 million and decreased consulting and professional fees of $1.1 million .
Net loss. $28.5 million and $2.78 , respectively, compared to a net loss and net loss per share of $23.2 million and $7.28 for the comparable period in 2022, respectively. Net loss for 2023 included a $0.6 million loss from discontinued operations, net of income taxes, and net loss for 2022 included income of $10.7 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.
Investor Relations:
Tyler Zeronda
Cautionary Statement Regarding Forward-Looking Statements
VYNE THERAPEUTICS INC. December 31, 2023 2022 Assets Current Assets: Cash and cash equivalents $ 30,620 $ 30,908 Restricted cash 54 67 Investment in marketable securities 62,633 — Amount due from sale of MST Franchise — 5,000 Prepaid and other current assets 2,656 2,300 Total Current Assets 95,963 38,275 Non-current Assets: Operating lease right-of-use assets 207 — Non-current prepaid expenses and other assets 1,515 2,483 Total Non-current Assets 1,722 2,483 Total Assets $ 97,685 $ 40,758 Liabilities, Mezzanine Equity and Shareholders’ Equity Current Liabilities: Trade payables $ 1,659 $ 2,386 Accrued expenses 4,119 4,381 Employee-related obligations 1,645 2,372 Liability for employee severance benefits — 206 Operating lease liabilities 115 — Total Current Liabilities 7,538 9,345 Long-term Liabilities : Non-current operating lease liabilities 99 — Other liabilities 1,313 — Total Long-term Liabilities 1,412 — Total Liabilities 8,950 9,345 Commitments and Contingencies Mezzanine Equity: Convertible Preferred Stock: $0.00 01 par value; 20,000,000 shares authorized at December 31, 2023 and December 31, 2022; Series A Preferred Stock: 0 and 3,000 shares issued and outstanding at December 31, 2023 and December 31, 2022, respectively — 211 Shareholders' Equity: Preferred stock: $0.00 01 par value; 20,000,000 shares authorized at December 31, 2023 and December 31, 2022, respectively; no shares issued and outstanding at December 31, 2023 and December 31, 2022, respectively — — Common stock: $0.00 01 par value; 150,000,000 shares authorized at December 31, 2023 and December 31, 2022; 14,098,888 and 3,229,704 shares issued and outstanding at December 31, 2023 and December 31, 2022, respectively 1 — Additional paid-in capital 780,044 693,937 Accumulated other comprehensive income 26 — Accumulated deficit (691,336 ) (662,735 ) Total Shareholders' Equity 88,735 31,202 Total Liabilities, Mezzanine Equity and Shareholders’ Equity $ 97,685 $ 40,758
VYNE THERAPEUTICS INC. Three Months Ended December 31, Year ended December 31, 2023 2022 2023 2022 Revenues Royalty revenues $ 76 $ 6 $ 424 $ 477 Total Revenues 76 6 424 477 Operating Expenses: Research and development 3,023 4,279 16,307 18,385 General and administrative 3,885 3,711 13,375 16,387 Total Operating Expenses 6,908 7,990 29,682 34,772 Operating Loss (6,832 ) (7,984 ) (29,258 ) (34,295 ) Other income, net 680 236 1,386 363 Loss from continuing operations before income taxes (6,152 ) (7,748 ) (27,872 ) (33,932 ) Income tax expense — 13 — 13 Loss from continuing operations (6,152 ) $ (7,761 ) (27,872 ) (33,945 ) (Loss) income from discontinued operations, net of income taxes (36 ) (2,184 ) (580 ) 10,735 Net Loss $ (6,188 ) $ (9,945 ) $ (28,452 ) $ (23,210 ) Loss per share from continuing operations, basic and diluted $ (0.20 ) $ (2.60 ) $ (2.72 ) $ (10.65 ) (Loss) income per share from discontinued operations, basic and diluted $ — $ (0.73 ) $ (0.06 ) $ 3.37 Loss per share, basic and diluted $ (0.20 ) $ (3.33 ) $ (2.78 ) $ (7.28 ) Weighted average shares outstanding - basic and diluted 31,050 2,985 10,273 3,186
Non-GAAP Financial Measures
In evaluating the operating performance of its business, VYNE’s management considers adjusted net loss, adjusted net loss per share, adjusted loss from continuing operations, adjusted total operating expenses (including adjusted research and development expense and adjusted 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 and years ended December 31, 2023 and 2022. Some amounts in the tables below may not add due to rounding.
The following tables provide detailed reconciliations of measures presented in this press release and other income statement data between GAAP and non-GAAP amounts for the three months and years ended December 31, 2023 and 2022:
Reconciliation of net loss to adjusted net loss and net loss per share to adjusted net loss per share:
Three Months Ended December 31, Year ended December 31, (in thousands, except per share data) 2023 2022 2023 2022 Net loss (GAAP) $ (6,188 ) $ (9,945 ) $ (28,452 ) $ (23,210 ) Add-back: stock-based compensation expense 710 1,067 3,305 4,297 Adjusted net loss (non-GAAP) $ (5,478 ) $ (8,878 ) $ (25,147 ) $ (18,913 ) Net loss per share, basic and diluted (GAAP) $ (0.20 ) $ (3.33 ) $ (2.78 ) $ (7.28 ) Add-back: stock-based compensation expense 0.02 0.36 0.32 1.35 Adjusted net loss per share, basic and diluted (non-GAAP) $ (0.18 ) $ (2.97 ) $ (2.45 ) $ (5.93 ) Weighted average number of shares outstanding, basic and diluted 31,050 2,985 10,273 3,186
Three Months Ended December 31, Year ended December 31, (in thousands, except per share data) 2023 2022 2023 2022 Loss from continuing operations (GAAP) $ (6,152 ) $ (7,761 ) $ (27,872 ) $ (33,945 ) Add-back: stock-based compensation expense 710 1,067 3,305 4,649 Adjusted loss from continuing operations (non-GAAP) $ (5,442 ) $ (6,694 ) $ (24,567 ) $ (29,296 ) Research and development expense (GAAP) $ 3,023 $ 4,279 $ 16,307 $ 18,385 Less: stock-based compensation expense (135 ) (253 ) (534 ) (1,230 ) Adjusted research and development expense (non-GAAP) $ 2,888 $ 4,026 $ 15,773 $ 17,155 General and administrative expense (GAAP) $ 3,885 $ 3,711 $ 13,375 $ 16,387 Less: stock-based compensation expense (575 ) (814 ) (2,771 ) (3,419 ) Adjusted general and administrative expense (non-GAAP) $ 3,310 $ 2,897 $ 10,604 $ 12,968 Total operating expenses (GAAP) $ 6,908 $ 7,990 $ 29,682 $ 34,772 Less: stock-based compensation expense (710 ) (1,067 ) (3,305 ) (4,649 ) Adjusted total operating expenses (non-GAAP) $ 6,198 $ 6,923 $ 26,377 $ 30,123 Operating loss (GAAP) $ (6,832 ) $ (7,984 ) $ (29,258 ) $ (34,295 ) Add back: stock-based compensation expense 710 1,067 3,305 4,649 Adjusted operating loss (non-GAAP) $ (6,122 ) $ (6,917 ) $ (25,953 ) $ (29,646 ) Loss per share from continuing operations, basic and diluted (GAAP) $ (0.20 ) $ (2.60 ) $ (2.72 ) $ (10.65 ) Add back: stock-based compensation expense 0.02 0.36 0.32 1.46 Adjusted loss per share from continuing operations, basic and diluted (non-GAAP) $ (0.18 ) $ (2.24 ) $ (2.40 ) $ (9.19 ) Weighted average number of shares outstanding - basic and diluted 31,050 2,985 10,273 3,186
What clinical milestone did VYNE achieve in 2023?
VYNE achieved clinical proof-of-concept for VYN201 in vitiligo.
How much cash did VYNE end 2023 with?
VYNE ended 2023 with $93.3 million in cash, cash equivalents, restricted cash, and marketable securities.
What trials are planned for VYN201 and VYN202 in Q2 2024?
VYNE plans to commence a Phase 2b trial for VYN201 and a Phase 1a trial for VYN202 in Q2 2024.
What were the revenues for VYNE in 2023?
VYNE's revenues for 2023 totaled $0.4 million.
How much were the research and development expenses for VYNE in 2023?
VYNE's research and development expenses for 2023 were $16.3 million.
What was the net loss for VYNE in 2023?
VYNE's net loss for 2023 was $28.5 million.
