VYNE Therapeutics Reports Third Quarter 2023 Financial Results and Provides Business Update
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Transformative capital raise of
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., Nov. 13, 2023 (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 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
Recent Corporate Update
Recent Pipeline Updates
VYN201, a locally-administered pan-BD BET inhibitor:
- Positive topline Phase 1b results in nonsegmental vitiligo. Significant clinical improvement was observed in the
1% and2% dosing cohorts with rapid onset of action and a dose-dependent response. The mean percentage reduction in F-VASI (facial vitiligo scoring index) score from baseline after 16 weeks of treatment was7.5% ,30.2% and39.0% for the0.5% ,1.0% and2.0% cohorts, respectively. In addition, VYN201 was generally well-tolerated with a favorable safety profile in vitiligo patients at all dose levels, with no serious adverse events reported and no abnormal laboratory values suggestive of low or reducing platelet counts. VYNE has initiated Phase 2b preparatory activities and expects to advance VYN201 into a longer duration Phase 2b trial to evaluate optimal dosing and peak efficacy in patients with active and stable nonsegmental vitiligo in the first half of 2024, with top-line results expected in mid-2025.
VYN202, an oral small molecule BD2-selective BET inhibitor:
- Psoriasis and rheumatoid arthritis selected as lead indications with IND submission expected by year-end. Based on positive preclinical data from well-established animal models, VYNE has selected moderate-to-severe plaque psoriasis and moderate-to-severe adult-onset rheumatoid arthritis as the lead indications for its VYN202 program. VYNE expects to submit its IND for VYN202 by year-end 2023 and commence a first-in-human Phase 1a single ascending dose/multiple ascending dose trial in the first quarter of 2024. Upon successful completion of the Phase 1a trial, the Company expects to initiate Phase 1b proof-of-concept trials in these indications in the second half of 2024, with top-line results expected in mid-2025.
| Financial Performance (in thousands) | Three Months Ended September 30 | Nine Months Ended September 30 | |||||||||||||
| 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 release.
Liquidity and Capital Resources
As of September 30, 2023, VYNE had cash and cash equivalents and restricted cash of
Financial Results for the Third Quarter Ended September 30, 2023
Revenues. Revenues for the quarter ended September 30, 2023 totaled
Research and development expenses. VYNE’s research and development expenses for the quarter ended September 30, 2023 were
Selling, general and administrative expenses. VYNE’s selling, general and administrative expenses for the quarter ended September 30, 2023 were
Net loss. Net loss and net loss per share for the quarter ended September 30, 2023 was
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:
John Fraunces
LifeSci Advisors, LLC
917-355-2395
jfraunces@lifesciadvisors.com
Tyler Zeronda
VYNE Therapeutics Inc.
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 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. Given these risks and uncertainties, you should not rely upon forward-looking statements as predictions of future events.
| VYNE THERAPEUTICS INC. CONDENSED CONSOLIDATED BALANCE SHEETS (U.S. dollars in thousands, except share and per share data) (Unaudited) | |||||||
| September 30 | December 31 | ||||||
| 2023 | 2022 | ||||||
| Assets | |||||||
| Current Assets: | |||||||
| Cash and cash equivalents | $ | 15,448 | $ | 30,908 | |||
| Restricted cash | 54 | 67 | |||||
| Trade receivables, net of allowances | 250 | 173 | |||||
| Amount due from sale of MST Franchise | — | 5,000 | |||||
| Prepaid and other expenses | 1,759 | 2,127 | |||||
| Total Current Assets | 17,511 | 38,275 | |||||
| Non-current prepaid expenses and other assets | 1,756 | 2,483 | |||||
| Total Assets | $ | 19,267 | $ | 40,758 | |||
| Liabilities, Mezzanine Equity and Stockholders’ Equity | |||||||
| Current Liabilities: | |||||||
| Trade payables | $ | 716 | $ | 2,386 | |||
| Accrued expenses | 4,452 | 4,381 | |||||
| Employee related obligations | 1,281 | 2,372 | |||||
| Liability for employee severance benefits | — | 206 | |||||
| Total Current Liabilities | 6,449 | 9,345 | |||||
| Other liabilities | 1,313 | — | |||||
| Total Liabilities | 7,762 | 9,345 | |||||
| Commitments and Contingencies | |||||||
| Mezzanine Equity: | |||||||
| Convertible Preferred Stock: | — | 211 | |||||
| Stockholders’ Equity: | |||||||
| Common stock: | — | — | |||||
| Additional paid-in capital | 696,653 | 693,937 | |||||
| Accumulated deficit | (685,148 | ) | (662,735 | ) | |||
| Total Stockholders’ Equity | 11,505 | 31,202 | |||||
| Total Liabilities, Mezzanine Equity and Stockholders’ Equity | $ | 19,267 | $ | 40,758 | |||
| VYNE THERAPEUTICS INC. CONDENSED CONSOLIDATED STATEMENTS OF OPERATIONS (U.S. dollars in thousands, except per share data) (Unaudited) | |||||||||||||||
| Three Months Ended September 30 | Nine Months Ended September 30 | ||||||||||||||
| 2023 | 2022 | 2023 | 2022 | ||||||||||||
| Revenues | |||||||||||||||
| Royalty revenues | $ | 114 | $ | 167 | $ | 348 | $ | 471 | |||||||
| Total revenues | 114 | 167 | 348 | 471 | |||||||||||
| Operating expenses: | |||||||||||||||
| Research and development | 3,318 | 5,546 | 13,284 | 14,106 | |||||||||||
| Selling, general and administrative | 3,030 | 3,954 | 9,490 | 12,676 | |||||||||||
| Total operating expenses | 6,348 | 9,500 | 22,774 | 26,782 | |||||||||||
| Operating loss | (6,234 | ) | (9,333 | ) | (22,426 | ) | (26,311 | ) | |||||||
| Other income, net | 163 | 78 | 706 | 127 | |||||||||||
| Loss from continuing operations before income taxes | (6,071 | ) | (9,255 | ) | (21,720 | ) | (26,184 | ) | |||||||
| Income tax expense | — | — | — | — | |||||||||||
| Loss from continuing operations | (6,071 | ) | $ | (9,255 | ) | (21,720 | ) | (26,184 | ) | ||||||
| (Loss) income from discontinued operations, net of income taxes | (513 | ) | (204 | ) | (544 | ) | 12,919 | ||||||||
| Net loss | $ | (6,584 | ) | $ | (9,459 | ) | $ | (22,264 | ) | $ | (13,265 | ) | |||
| Loss per share from continuing operations, basic and diluted | $ | (1.85 | ) | $ | (2.88 | ) | $ | (6.66 | ) | $ | (8.25 | ) | |||
| (Loss) income per share from discontinued operations, basic and diluted | $ | (0.16 | ) | $ | (0.06 | ) | $ | (0.17 | ) | $ | 4.07 | ||||
| Loss per share, basic and diluted | $ | (2.01 | ) | $ | (2.94 | ) | $ | (6.82 | ) | $ | (4.18 | ) | |||
| Weighted average shares outstanding - basic and diluted | 3,282 | 3,218 | 3,271 | 3,173 | |||||||||||
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 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 and nine months ended September 30, 2023 and 2022. The following tables reconcile non-GAAP financial measures presented in this press release.
The following tables provides detailed reconciliations of various other income statement data between GAAP and non-GAAP amounts for the three and nine months ended September 30, 2023 and 2022 (in thousands, except per share data):
Reconciliation of net loss to adjusted net loss and net loss per share to adjusted net loss per share:
| Three Months Ended September 30 | Nine Months Ended September 30 | ||||||||||||||
| (in thousands, except per share data) | 2023 | 2022 | 2023 | 2022 | |||||||||||
| Net loss (GAAP) | $ | (6,584 | ) | $ | (9,459 | ) | $ | (22,264 | ) | $ | (13,265 | ) | |||
| Add-back: stock-based compensation expense | 863 | 1,174 | 2,595 | 3,230 | |||||||||||
| Adjusted net loss (non-GAAP) | $ | (5,721 | ) | $ | (8,285 | ) | $ | (19,669 | ) | $ | (10,035 | ) | |||
| Net loss per share, basic and diluted (GAAP) | $ | (2.01 | ) | $ | (2.94 | ) | $ | (6.82 | ) | $ | (4.18 | ) | |||
| Add-back: stock-based compensation expense | 0.26 | 0.36 | 0.79 | 1.02 | |||||||||||
| Adjusted net loss per share, basic and diluted (non-GAAP) | $ | (1.75 | ) | $ | (2.58 | ) | $ | (6.03 | ) | $ | (3.16 | ) | |||
| Weighted average number of shares outstanding, basic and diluted | 3,282 | 3,218 | 3,271 | 3,173 | |||||||||||
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 expenses to adjusted total operating expenses; operating loss to adjusted operating loss; and loss per share from continuing operations to adjusted loss per share from continuing operations:
| Three Months Ended September 30 | Nine Months Ended September 30 | ||||||||||||||
| (in thousands, except per share data) | 2023 | 2022 | 2023 | 2022 | |||||||||||
| Loss from continuing operations (GAAP) | $ | (6,071 | ) | $ | (9,255 | ) | $ | (21,720 | ) | $ | (26,184 | ) | |||
| Add-back: stock-based compensation expense | 863 | 1,174 | 2,595 | 3,582 | |||||||||||
| Adjusted loss from continuing operations (non-GAAP) | $ | (5,208 | ) | $ | (8,081 | ) | $ | (19,125 | ) | $ | (22,602 | ) | |||
| Research and development expense (GAAP) | $ | 3,318 | $ | 5,546 | $ | 13,284 | $ | 14,106 | |||||||
| Less: stock-based compensation expense | (207 | ) | (355 | ) | (399 | ) | (977 | ) | |||||||
| Adjusted research and development expense (non-GAAP) | $ | 3,111 | $ | 5,191 | $ | 12,885 | $ | 13,129 | |||||||
| Selling, general and administrative expense (GAAP) | $ | 3,030 | $ | 3,954 | $ | 9,490 | $ | 12,676 | |||||||
| Less: stock-based compensation expense | (656 | ) | (819 | ) | (2,196 | ) | (2,605 | ) | |||||||
| Adjusted selling, general and administrative expense (non-GAAP) | $ | 2,374 | $ | 3,135 | $ | 7,294 | $ | 10,071 | |||||||
| Total operating expenses (GAAP) | $ | 6,348 | $ | 9,500 | $ | 22,774 | $ | 26,782 | |||||||
| Less: stock-based compensation expense | (863 | ) | (1,174 | ) | (2,595 | ) | (3,582 | ) | |||||||
| Adjusted total operating expenses (non-GAAP) | $ | 5,485 | $ | 8,326 | $ | 20,179 | $ | 23,200 | |||||||
| Operating loss (GAAP) | $ | (6,234 | ) | $ | (9,333 | ) | $ | (22,426 | ) | $ | (26,311 | ) | |||
| Add back: stock-based compensation expense | 863 | 1,174 | 2,595 | 3,582 | |||||||||||
| Adjusted operating loss (non-GAAP) | $ | (5,371 | ) | $ | (8,159 | ) | $ | (19,831 | ) | $ | (22,729 | ) | |||
| Loss per share from continuing operations, basic and diluted (GAAP) | $ | (1.85 | ) | $ | (2.88 | ) | $ | (6.66 | ) | $ | (8.25 | ) | |||
| Add back: stock-based compensation expense | 0.26 | 0.36 | 0.79 | 1.13 | |||||||||||
| Adjusted loss per share from continuing operations, basic and diluted (non-GAAP) | $ | (1.59 | ) | $ | (2.52 | ) | $ | (5.87 | ) | $ | (7.12 | ) | |||
| Weighted average number of shares outstanding - basic and diluted | 3,282 | 3,218 | 3,271 | 3,173 | |||||||||||
FAQ
What is the recent corporate update from VYNE Therapeutics Inc.?
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What are the financial results for the third quarter ended September 30, 2023, for VYNE Therapeutics Inc.?
