VYNE Therapeutics Reports 2024 Fourth Quarter and Year-End Financial Results and Provides Business Update

Rhea-AI Summary

VYNE Therapeutics has reported its Q4 and full-year 2024 financial results, highlighting significant progress in its clinical pipeline. The company's key developments include:

The completion of enrollment in the Phase 2b trial of repibresib gel (VYN201) for nonsegmental vitiligo, with top-line results expected in mid-2025. The trial evaluates three dose cohorts (1%, 2%, 3%) against vehicle control in approximately 180 subjects.

Additionally, VYNE initiated a Phase 1b trial of VYN202, their oral BD2-selective BET inhibitor, for moderate-to-severe plaque psoriasis, with results anticipated by year-end 2025.

Financial highlights include:

• Cash position of $61.5 million as of December 31, 2024
• Expected runway into second half of 2026
• 2024 revenue of $0.5 million
• Net loss of $39.8 million ($0.93 per share)
• R&D expenses increased to $30.9 million from $16.3 million in 2023

Positive

• Strong cash position of $61.5M with runway into 2H 2026
• Phase 2b vitiligo trial fully enrolled with results expected mid-2025
• New Phase 1b trial initiated for VYN202 in psoriasis

Negative

• Increased net loss to $39.8M from $28.5M YoY
• R&D expenses nearly doubled to $30.9M
• Minimal revenue of only $0.5M for 2024

Insights

Financial Analyst

VYNE Therapeutics' financial report reveals mixed signals for investors. While the company's net loss increased to $39.8 million from $28.5 million in 2023, the loss per share significantly decreased to $0.93 from $2.78, indicating substantial share dilution has occurred. The near-doubling of R&D expenses to $30.9 million reflects targeted investment in clinical programs rather than operational inefficiency.

The company's cash position of $61.5 million provides runway into 2H 2026, covering the upcoming clinical readouts without immediate financing pressure. This cash reserve exceeds the current market cap of approximately $34 million, creating a negative enterprise value scenario that reflects extreme market skepticism about VYNE's clinical assets.

The marginal revenue ($0.5 million) from royalties highlights VYNE's complete dependence on clinical success for future value creation. While the increased R&D spending reflects necessary pipeline investment, the burn rate of approximately $40 million annually against $61.5 million cash reserves suggests that positive clinical data will be essential to avoid unfavorable financing terms in the future.

Dermatology Clinical Research Expert

VYNE's clinical pipeline shows focused advancement in dermatology with two programs reaching significant milestones. The completed enrollment for repibresib gel's Phase 2b trial in vitiligo represents a major development step for this pan-BD BET inhibitor. With 180 patients randomized across three dose cohorts (1%, 2%, 3%) and vehicle control, the trial is appropriately sized to detect efficacy signals.

The study design includes a 24-week controlled period followed by a 28-week extension phase, enabling assessment of both initial efficacy and longer-term safety and durability - critical factors in chronic conditions like vitiligo. The mid-2025 data readout will be pivotal, as the vitiligo treatment landscape has approved options, with topical ruxolitinib (JAK inhibitor) being the most notable recent addition.

Simultaneously, VYNE has initiated the Phase 1b trial for VYN202, their oral BD2-selective inhibitor, in plaque psoriasis. Unlike the vitiligo space, psoriasis represents a highly competitive market dominated by biologics, making the bar for success considerably higher. The 12-week trial with approximately 80 patients across three dose cohorts will provide preliminary safety and efficacy signals by year-end 2025, determining whether this oral alternative can carve out a niche in this crowded market.

• Repibresib gel (VYN201) Phase 2b vitiligo top-line results expected in mid-2025
• VYN202 Phase 1b psoriasis trial initiated with results anticipated by year-end 2025
• Expected cash runway into 2H 2026
  

BRIDGEWATER, N.J., March 06, 2025 (GLOBE NEWSWIRE) -- VYNE Therapeutics Inc. (Nasdaq: VYNE) (“VYNE” or the “Company”), a clinical-stage biopharmaceutical company focused on developing differentiated therapies to treat chronic inflammatory and immune-mediated conditions with high unmet need, today announced financial results as of and for the fourth quarter and year ended December 31, 2024, and provided a business update.

“Based on our significant progress in 2024, we are now positioned to announce two key data readouts for repibresib gel and VYN202 in 2025,” said David Domzalski, President and Chief Executive Officer of VYNE. “We are off to a strong start in 2025. In January, we announced the completion of enrollment in the Phase 2b trial of our locally administered pan-BD BET inhibitor, repibresib, in nonsegmental vitiligo, and we expect to report topline results in mid-2025. We also recently initiated the Phase 1b trial of our oral BD2-selective BET inhibitor, VYN202, in subjects with moderate-to-severe plaque psoriasis, and we anticipate reporting topline results from this trial by the end of this year.”

Recent Pipeline Updates

Repibresib gel (VYN201), a locally-administered small molecule pan-BD BET inhibitor (Phase 2b, nonsegmental vitiligo):

• Top-line results from the Phase 2b trial are expected in mid-2025. The fully enrolled, Phase 2b trial (NCT06493578) is a randomized, double-blind, vehicle-controlled trial evaluating the efficacy, safety and pharmacokinetics of once-daily repibresib gel in three dose cohorts (1%, 2% or 3% concentrations) compared to vehicle for 24 weeks in subjects with active or stable nonsegmental vitiligo. Subjects have been randomized equally (1:1:1:1 ratio) across the active drug cohorts or vehicle (approximately 45 subjects in each arm). Top-line results from the 24-week double-blind, vehicle-controlled portion of the trial are expected mid-year.
  
  
• Following the 24-week treatment period, subjects who have been randomized in the three active dose cohorts will continue treatment with their respective dose concentrations for an additional 28-week active treatment extension. Subjects who have been randomized in the vehicle group during the initial 24-week treatment period will be equally re-randomized into one of the three active dose cohorts for an additional 28 weeks.
  

VYN202, an oral small molecule BD2-selective inhibitor:

• Top-line results from the Phase 1b trial are expected by year-end 2025. In February 2025, the Company announced the initiation of patient enrollment in the Phase 1b trial which is a randomized, double-blind, placebo-controlled trial evaluating the safety, tolerability and pharmacokinetics of once-daily VYN202 in three dosing cohorts (0.25 mg, 0.5 mg, 1 mg doses) compared to placebo, for 12 weeks in subjects with moderate-to-severe plaque psoriasis. Exploratory efficacy of VYN202 will also be evaluated, including measures of psoriasis area and severity index, Static Physician Global Assessment, scalp disease, quality of life, and biomarker analyses.
  
  
• Subjects will be randomized equally (1:1:1:1, approximately 20 subjects per arm) across the active drug cohorts or placebo. Following the 12-week treatment period, all subjects will be followed for a 4-week safety period.
  

Upcoming Conference Participation

• Investor Conferences. VYNE will be participating in the upcoming Leerink Partners Global Healthcare Conference, taking place in Miami from March 10-12, 2025, as well as the H.C. Wainwright 3rd Annual Autoimmune & Inflammatory Disease Virtual Conference being held on March 27, 2025.
  

Financial Results as of and for the Year Ended December 31, 2024

Cash position. As of December 31, 2024, VYNE had $61.5 million of cash, cash equivalents and marketable securities. Based on current operating assumptions, VYNE believes its cash, cash equivalents and marketable securities as of December 31, 2024 will be sufficient to fund its operations into the second half of 2026.

Share count. As of December 31, 2024, VYNE had 14,830,013 common shares issued and outstanding, and outstanding pre-funded warrants to purchase 27,842,740 shares of common stock at an exercise price of $0.0001 per share.

Revenues. Revenues totaled $0.5 million and $0.4 million for the years ended December 31, 2024 and 2023, respectively, consisting of royalty revenue from the Company's royalty agreement with LEO Pharma A/S, to whom VYNE previously licensed the rights to Finacea^® foam.

Research and development expenses. VYNE’s research and development expenses for the years ended December 31, 2024 and 2023 were $30.9 million and $16.3 million, respectively. The increase was primarily due to an increase of $11.7 million in expenses for repibresib, an increase of $2.5 million in expenses for VYN202 and an increase of $0.8 million of employee-related expenses following the hiring of additional research and development personnel. The $11.7 million increase in expenses for repibresib primarily relates to preparatory activity and clinical trial costs incurred for VYNE's ongoing Phase 2b trial of repibresib in subjects with nonsegmental vitiligo. The $2.5 million increase in expenses for VYN202 is primarily associated with costs incurred for our Phase 1a SAD/MAD trial which was completed in the fourth quarter of 2024. Both trials were initiated in June 2024. These increases were partially offset by lower consulting expenses of $0.4 million.

General and administrative expenses. VYNE’s general and administrative expenses for the years ended December 31, 2024 and 2023 were approximately $13.2 million and $13.4 million, respectively. The decrease was primarily driven by a reduction in employee related expenses of $0.9 million, partially offset by increased consulting and professional fees of $0.8 million.

Net loss. Net loss and net loss per share for the year ended December 31, 2024 was $39.8 million and $0.93, respectively, compared to a net loss and net loss per share of $28.5 million and $2.78, for the comparable period in 2023.

About VYNE Therapeutics Inc.

VYNE is a clinical-stage biopharmaceutical company focused on developing differentiated therapies to treat chronic inflammatory and immune-mediated conditions with high unmet need. VYNE's unique and proprietary BET inhibitors, which comprise its InhiBET™ platform, are designed to overcome limitations of early generation BET inhibitors by leveraging alternative routes of administration and enhanced selectivity.

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

Media Relations:
Mike Beyer
Sam Brown Inc.
312-961-2502
mikebeyer@sambrown.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 clinical development of, and timing for reporting top-line results from trials of, repibresib and VYN202, the impact of the reported top-line results from trials on clinical development, VYNE's participation in upcoming conferences, VYNE’s projected cash runway, 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 preclinical studies and clinical trials; VYNE’s ability to complete and receive favorable results from clinical trials of its product candidates; VYNE’s ability to obtain additional funding, either through equity or debt financing transactions or collaboration arrangements; and VYNE’s ability to comply with various regulations applicable to its business. 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, 2024, and VYNE’s other filings from time to time 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.

Third-party products and company names mentioned herein may be the trademarks of their respective owners.

VYNE THERAPEUTICS INC. CONSOLIDATED BALANCE SHEETS (U.S. dollars in thousands, except share and per share data) (Unaudited)
		December 31
			2024				2023
Assets
Current Assets:
Cash and cash equivalents		$	19,926			$	30,620
Restricted cash			—				54
Investment in marketable securities			41,590				62,633
Prepaid and other current assets			2,921				2,656
Total Current Assets			64,437				95,963
Non-current Assets:
Property and equipment, net			113				—
Operating lease right of use assets			93				207
Non-current prepaid expenses and other assets			2,262				1,515
Total Non-current Assets			2,468				1,722
Total Assets		$	66,905			$	97,685
Liabilities and Shareholders’ Equity
Current Liabilities:
Trade payables		$	2,707			$	1,659
Accrued expenses			9,272				4,119
Employee-related obligations			1,428				1,645
Operating lease liabilities			99				115
Other current liabilities			1,313				—
Total Current Liabilities			14,819				7,538
Long-term Liabilities:
Non-current operating lease liabilities			—				99
Other liabilities			—				1,313
Total Long-term Liabilities			—				1,412
Total Liabilities			14,819				8,950
Commitments and Contingencies
Shareholders' Equity:
Preferred stock: $0.0001 par value; 20,000,000 shares authorized at December 31, 2024 and 2023; no shares issued and outstanding at December 31, 2024 and 2023			—				—
Common stock: $0.0001 par value; 150,000,000 shares authorized at December 31, 2024 and December 31, 2023; 14,830,013 and 14,098,888 shares issued and outstanding at December 31, 2024 and 2023, respectively			1				1
Additional paid-in capital			783,235				780,044
Accumulated other comprehensive income			20				26
Accumulated deficit			(731,170	)			(691,336	)
Total Shareholders' Equity			52,086				88,735
Total Liabilities and Shareholders’ Equity		$	66,905			$	97,685

VYNE THERAPEUTICS INC. CONSOLIDATED STATEMENTS OF OPERATIONS (U.S. dollars in thousands, except per share data) (Unaudited)
		Three Months Ended December 31,								Year Ended December 31,
			2024				2023				2024				2023
Revenues
Royalty revenues		$	84			$	76			$	501			$	424
Total revenues			84				76				501				424
Operating expenses
Research and development			9,684				3,023				30,946				16,307
General and administrative			3,170				3,885				13,192				13,375
Total operating expenses			12,854				6,908				44,138				29,682
Operating loss			(12,770	)			(6,832	)			(43,637	)			(29,258	)
Other income, net			760				680				3,834				1,386
Loss from continuing operations before income taxes			(12,010	)			(6,152	)			(39,803	)			(27,872	)
Income tax expense			4				—				4				—
Loss from continuing operations			(12,014	)		$	(6,152	)			(39,807	)			(27,872	)
Loss from discontinued operations, net of income taxes			(8	)			(36	)			(27	)			(580	)
Net loss		$	(12,022	)		$	(6,188	)		$	(39,834	)		$	(28,452	)
Loss per share from continuing operations, basic and diluted		$	(0.28	)		$	(0.20	)		$	(0.93	)		$	(2.72	)
Loss per share from discontinued operations, basic and diluted		$	0.00			$	0.00			$	0.00			$	(0.06	)
Loss per share, basic and diluted		$	(0.28	)		$	(0.20	)		$	(0.93	)		$	(2.78	)
Weighted average shares outstanding - basic and diluted			42,597				31,050				42,589				10,273

FAQ

When will VYNE Therapeutics report Phase 2b results for repibresib gel in vitiligo treatment?

VYNE expects to report top-line results from the Phase 2b trial of repibresib gel in nonsegmental vitiligo in mid-2025.

What is VYNE's current cash runway based on their Q4 2024 financial results?

Based on current operating assumptions, VYNE's $61.5 million cash position is expected to fund operations into the second half of 2026.

How much did VYNE's R&D expenses increase in 2024 compared to 2023?

R&D expenses increased by $14.6 million, from $16.3 million in 2023 to $30.9 million in 2024, primarily due to clinical trial costs.

What was VYNE Therapeutics' net loss per share for the full year 2024?

VYNE reported a net loss of $0.93 per share for the year ended December 31, 2024.

How many patients are enrolled in VYNE's Phase 2b vitiligo trial for repibresib gel?

The trial has approximately 180 subjects, with about 45 subjects randomized equally across three active drug cohorts and one vehicle control group.