VYNE Reports First Quarter 2024 Financial Results and Provides Business Update

Rhea-AI Summary

VYNE Therapeutics Inc. reported its First Quarter 2024 Financial Results and provided a business update. The company made steady progress on its VYN201 program towards a Phase 2b trial, with the design finalized. IND clearance was received for VYN202, with expectations to dose healthy volunteers in Phase 1a trial this quarter.

Financially, VYNE had $86.0 million in cash and marketable securities as of March 31, 2024, believed to be sufficient to fund operations through 2025. Revenues were $0.1 million for Q1 2024 and 2023, mainly from royalty revenue. Research and development expenses increased by 35.6%, and general and administrative expenses increased by 16.4%.

Positive

• Steady progress in advancing VYN201 program towards a Phase 2b trial.

• IND clearance received for VYN202 program.

• Cash, cash equivalents, and marketable securities of $86.0 million as of March 31, 2024.

• Revenues of $0.1 million for Q1 2024 and 2023 from royalty revenue.

Negative

• Net loss of $6.2 million and net loss per share of $0.15 for the quarter ended March 31, 2024.

• Research and development expenses increased by 35.6% compared to Q1 2023.

• General and administrative expenses increased by 16.4% compared to Q1 2023.

Insights

Biotech Analyst

VYNE Therapeutics' recent developments present an intriguing narrative for investors surveying the biotech landscape. The company is advancing VYN201, its topical therapy for nonsegmental vitiligo, into Phase 2b trials, which marks a critical juncture in its clinical roadmap. Enrolling 160 subjects indicates a comprehensive study that could address a significant unmet medical need. Given the robust design of the study, including a 24-week treatment period with a subsequent 28-week active extension, the dataset upon completion will be substantial. Investors should note the mid-2025 target for reporting top-line results from the double-blind portion, as the timeline is essential for gauging investment horizons. The IND-clearance for VYN202's Phase 1a SAD/MAD trials is another significant milestone. The fact that this oral small molecule targets BD2-selective BET inhibition opens up potential for a novel approach in treating immuno-inflammatory conditions like psoriasis and rheumatoid arthritis. The plan to report results later this year from this trial could catalyze investor interest, provided the outcomes are favorable. However, the trajectory from Phase 1a to potential commercialization is long and fraught with risk. This is compounded by the planned Phase 1b trials for 2025, which places potential market entry several years away at the earliest. Financially, VYNE's cash runway extending through the end of 2025 offers a cushion to achieve these clinical milestones without immediate dilutive financing. Still, the net loss of $6.2 million this quarter, albeit an increase from the previous year, reflects the capital-intensive nature of drug development. The relatively static revenue stream from their royalty agreement with LEO Pharma should be viewed in light of this larger financial picture. Investors should monitor future cash burn rates relative to clinical progress, as well as potential partnership or fundraising announcements that could impact financial stability.

Financial Analyst

From a fiscal standpoint, an increment of 35.6% in research and development expenses is quite significant, reflecting the company's investment towards advancing their drug candidates. While this is expected during the clinical trial stages, the impact on the company's bottom line is noticeable, as evidenced by the increased net loss from the comparative period last year. Investors should appreciate that increased R&D spends during such critical trial phases are indicative of a company aggressively pursuing regulatory milestones. It is nevertheless essential to balance such expenditures against the company's total cash position of $86.0 million. This position indicates a healthy runway, but the cautionary tale of biotech investing is one of uncertainty in clinical outcomes, meaning the current cash reserves must be judiciously managed. These financial results also highlight a very modest revenue stream and therefore, it is the clinical trial outcomes that will likely be the significant driver of future investor sentiment and stock performance.

Pharmaceutical Marketing Analyst

VYNE's strategic focus on immuno-inflammatory conditions aligns with a growing trend in the pharmaceutical industry to address diseases with high unmet needs and potential for targeted therapies. The fact that VYN201 is entering a Phase 2b trial for vitiligo, a condition with limited effective treatments, suggests that if successful, VYNE could tap into a specialized and underserved market. The marketing potential for a successful vitiligo treatment is substantial, considering the psychological impact of the disease and the demand for dermatological solutions. It's also noteworthy that they are seeking to expand their portfolio with VYN202 as an oral treatment, which could have advantages in patient compliance and preference compared to injectables commonly used in these conditions. However, it is important to remain cognizant of the competitive landscape, potential market size and the fact that these products are still in early stages of development. Investors should interpret these product pipelines as long-term potential rather than near-term catalysts.

• Design of Phase 2b trial for VYN201 in nonsegmental vitiligo finalized and on track to begin this quarter
• Phase 2b trial expected to enroll approximately 160 subjects with either active or stable nonsegmental vitiligo and will evaluate VYN201 gel in 1%, 2% and 3% concentrations compared to vehicle for 24 weeks, followed by a 28-week active treatment extension
• IND clearance received for oral BD2-selective BET inhibitor, VYN202; anticipate first healthy volunteers to be dosed in Phase 1a SAD/MAD trial this quarter
  

BRIDGEWATER, N.J., May 09, 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 as of and for the three months ended March 31, 2024 and provided a business update.

“During the first quarter, we made steady progress in advancing our VYN201 program toward a Phase 2b trial,” said David Domzalski, President and CEO of VYNE. “We are rapidly activating clinical trial sites and expect to dose the first subject in the trial this quarter. In addition, we recently received IND clearance for our VYN202 program to proceed and expect to dose the first healthy volunteers in our Phase 1a trial this quarter. We look forward to updating our stakeholders on our progress in the coming months.”

Recent Pipeline Updates

VYN201, a locally-administered pan-BD BET inhibitor:

• VYNE expects to enroll the first vitiligo subject in the Phase 2b trial for VYN201 this quarter. The Phase 2b trial will enroll subjects with either active or stable nonsegmental vitiligo and will be a randomized, double-blind, vehicle-controlled trial evaluating the efficacy, safety and pharmacokinetics of once-daily VYN201 gel in three dose cohorts (1%, 2% and 3% concentrations) compared to vehicle for 24 weeks. Subjects will be randomized at 1:1:1:1 ratio. Following the 24-week treatment period, subjects in the vehicle group will be equally re-randomized to receive VYN201 1%, 2% or 3% gel for an additional 28 weeks. VYNE expects to enroll approximately 40 subjects in each arm and to report top-line results from the 24-week double-blind portion of the trial in mid-2025.
  

VYN202, an oral small molecule BD2-selective BET inhibitor:

• VYNE's Investigational New Drug application for VYN202 was recently cleared by the U.S. Food & Drug Administration, and VYNE expects to dose the first healthy volunteers in the Phase 1a single ascending dose/multiple ascending dose ("SAD/MAD") trial this quarter. VYNE expects to report top-line results from the SAD/MAD trial in the second half of this year. If the Phase 1a 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.
  

Upcoming Conference Participation

• 2024 Society for Investigative Dermatology Annual Meeting - Dr. Iain Stuart, Chief Scientific Officer of VYNE, will present preclinical and Phase 1b data for VYN201 in vitiligo. The conference is being held on May 15-18, 2024 in Dallas, Texas.
  

Financial Results as of and for the First Quarter Ended March 31, 2024

Cash position. As of March 31, 2024, VYNE had cash, cash equivalents, restricted cash and marketable securities of $86.0 million. VYNE believes its cash, cash equivalents, restricted cash and marketable securities as of March 31, 2024 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 filed today for additional discussion on liquidity and capital resources.

Revenues. Revenues totaled $0.1 million for each of the three months ended March 31, 2024 and 2023, consisting of royalty revenue from the Company's royalty agreement with LEO Pharma, to whom VYNE previously licensed the rights to Finacea foam.

Research and development expenses. VYNE’s research and development expenses for the quarter ended March 31, 2024 were $3.7 million, representing an increase of $1.0 million, or 35.6%, compared to $2.7 million for the quarter ended March 31, 2023. The increase was primarily driven by preparatory activities for the Phase 1 trials for VYN202 and Phase 2b trial for VYN201 of $0.7 million and $0.3 million, respectively.

General and administrative expenses. VYNE’s general and administrative expenses for the quarter ended March 31, 2024 were $3.8 million, representing an increase of $0.5 million, or 16.4%, compared to $3.2 million for the quarter ended March 31, 2023. The increase was primarily driven by $0.3 million of consulting and professional fees and $0.2 million of employee-related expenses.

Net loss. Net loss and net loss per share for the quarter ended March 31, 2024 were $6.2 million and $0.15, respectively, compared to a net loss and net loss per share of $5.6 million and $1.74, respectively for the comparable period in 2023.

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 future clinical trials for VYN201 and VYN202, the expected timing for reporting top-line results from those trials, and 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, 2023, 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.

VYNE THERAPEUTICS INC. CONDENSED CONSOLIDATED BALANCE SHEETS (U.S. dollars in thousands, except share and per share data) (Unaudited)
	March 31				December 31
		2024				2023
Assets
Current Assets:
Cash and cash equivalents	$	19,065			$	30,620
Restricted cash		54				54
Investment in marketable securities		66,885				62,633
Prepaid and other expenses		4,219				2,656
Total Current Assets		90,223				95,963
Non-current Assets:
Operating lease right-of-use assets		180				207
Non-current prepaid expenses and other assets		1,273				1,515
Total Non-current Assets		1,453				1,722
Total Assets	$	91,676			$	97,685
Liabilities and Stockholders’ Equity
Current Liabilities:
Trade payables	$	2,795			$	1,659
Accrued expenses		3,642				4,119
Employee related obligations		376				1,645
Operating lease liabilities		117				115
Total Current Liabilities		6,930				7,538
Long-term Liabilities:
Non-current operating lease liabilities		63				99
Other liabilities		1,313				1,313
Total Long-term Liabilities		1,376				1,412
Total Liabilities		8,306				8,950
Commitments and Contingencies
Stockholders' Equity:
Preferred stock: $0.0001 par value; 20,000,000 shares authorized at March 31, 2024 and December 31, 2023, respectively; no shares issued and outstanding at March 31, 2024 and December 31, 2023, respectively		—				—
Common stock: $0.0001 par value; 150,000,000 shares authorized at March 31, 2024 and December 31, 2023; 14,301,688 and 14,098,888 shares issued and outstanding at March 31, 2024 and December 31, 2023, respectively		1				1
Additional paid-in capital		781,024				780,044
Accumulated other comprehensive (loss) income		(70	)			26
Accumulated deficit		(697,585	)			(691,336	)
Total Stockholders' Equity		83,370				88,735
Total Liabilities and Stockholders’ Equity	$	91,676			$	97,685

VYNE THERAPEUTICS INC. CONDENSED CONSOLIDATED STATEMENTS OF OPERATIONS (U.S. dollars in thousands, except per share data) (Unaudited)
	Three Months Ended March 31,
		2024				2023
Revenues
Royalty revenues	$	98			$	99
Total Revenues		98				99
Operating Expenses:
Research and development		3,708				2,734
General and administrative		3,770				3,240
Total Operating Expenses		7,478				5,974
Operating Loss		(7,380	)			(5,875	)
Other income, net		1,139				263
Loss from continuing operations before income taxes		(6,241	)			(5,612	)
Income tax expense		—				—
Loss from continuing operations	$	(6,241	)		$	(5,612	)
Loss from discontinued operations, net of income taxes		(8	)			(10	)
Net Loss	$	(6,249	)		$	(5,622	)
Loss per share from continuing operations, basic and diluted	$	(0.15	)		$	(1.74	)
Loss per share from discontinued operations, basic and diluted	$	0.00			$	0.00
Loss per share, basic and diluted	$	(0.15	)		$	(1.74	)
Weighted average shares outstanding - basic and diluted		42,581				3,255

FAQ

<p>What is VYNE's stock symbol?</p>

VYNE's stock symbol is VYNE.

<p>What is the design status of VYN201 program?</p>

The design of Phase 2b trial for VYN201 in nonsegmental vitiligo is finalized and on track to begin this quarter.

<p>What is the expected enrollment for the Phase 2b trial of VYN201?</p>

The Phase 2b trial is expected to enroll approximately 160 subjects with active or stable nonsegmental vitiligo.

<p>What is the purpose of the Phase 1a trial for VYN202?</p>

The Phase 1a trial for VYN202 aims to dose the first healthy volunteers in a SAD/MAD trial.

<p>What are the financial results for the first quarter of 2024?</p>

As of March 31, 2024, VYNE had cash, cash equivalents, restricted cash, and marketable securities of $86.0 million. Revenues were $0.1 million for the quarter.