VYNE Therapeutics Reports Third Quarter 2023 Financial Results and Provides Business Update
VYNE Therapeutics Inc. (Nasdaq: VYNE) announced an $88.2 million capital raise, extending funding for BET inhibitor programs through 2025. Positive Phase 1b results for VYN201 in vitiligo and on track for VYN202 IND submission by year-end 2023.
11/13/2023 - 07:45 AM
Transformative capital raise of $88.2 million from leading healthcare investors provides funding for BET inhibitor programs through the end of 2025
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 $88.2 million capital raise from premier healthcare investors significantly strengthens our balance sheet and we believe highlights the enthusiasm for our InhiBET™ platform,” continued Mr. Domzalski. “By extending our cash runway through the end of 2025, we can focus on executing our strategy of validating BET inhibition as a treatment for immuno-inflammatory conditions and delivering on key value-creating milestones.”
Recent Corporate Update
$88.2 million private placement with leading fundamental healthcare investors, extended cash runway through the end of 2025. $88.2 million , before deducting placement agent fees and offering expenses, from the sale of 10,652,543 shares of common stock at a purchase price of $2.24 5 per share and, in lieu of common stock to certain investors, pre-funded warrants to purchase up to an aggregate of 28,614,437 shares of common stock at a purchase price of $2.24 49 per pre-funded warrant. The net proceeds from the offering are expected to be used to fund the advancement of VYN201 into a Phase 2b clinical trial in vitiligo and Phase 1 trials for VYN202.
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% and 2% 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 was 7.5% , 30.2% and 39.0% for the 0.5% , 1.0% and 2.0% 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 $15.5 million . When adding the gross proceeds received from the PIPE, VYNE's cash and cash equivalents and restricted cash as of September 30, 2023 would have been approximately $103.7 million . VYNE currently anticipates that its cash and cash equivalents and restricted cash as of September 30, 2023, together with the gross proceeds from the PIPE, will be sufficient to fund its operations through the end of 2025. 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 September 30, 2023 for additional discussion on liquidity and capital resources.
Financial Results for the Third Quarter Ended September 30, 2023
Revenues. $0.1 million compared to $0.2 million for the quarter ended September 30, 2022, consisting of royalty revenue.
Research and development expenses $3.3 million , as compared to $5.5 million for the comparable period in 2022. The decrease was primarily driven by decreased spend for FMX114 and VYN201 and lower employee-related expenses. The decrease was partially offset by increased spend for VYN202.
Selling, general and administrative expenses. $3.0 million , compared to $4.0 million for the comparable period in 2022. The decrease was primarily driven by decreased consulting and professional fees and lower corporate insurance expenses.
Net loss. $6.6 million and $2.01 , respectively, compared to a net loss and net loss per share of $9.5 million and $2.94 for the comparable period in 2022, respectively. Net loss reported for the third quarter of 2023 reflected the impact of $0.5 million from discontinued operations, net of income taxes. The third quarter of 2022 reflected the impact of $0.2 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. 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: $0.00 01 par value; 20,000,000 shares authorized at September 30, 2023 and December 31, 2022; Series A Preferred Stock: 0 and 3,000 shares issued and outstanding at September 30, 2023 and December 31, 2022, respectively — 211 Stockholders’ Equity: Common stock: $0.00 01 par value; 150,000,000 shares authorized at September 30, 2023 and December 31, 2022; 3,304,781 and 3,229,704 shares issued and outstanding at September 30, 2023 and December 31, 2022, respectively — — 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 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
What is the recent corporate update from VYNE Therapeutics Inc.?
VYNE completed an $88.2 million private placement, extending cash runway through 2025.
What are the recent pipeline updates from VYNE Therapeutics Inc.?
VYN201 showed positive Phase 1b results in vitiligo. VYN202 IND submission expected by year-end 2023.
What are the financial results for the third quarter ended September 30, 2023, for VYNE Therapeutics Inc.?
Revenues totaled $0.1 million, research and development expenses were $3.3 million, and net loss was $6.6 million.
