VYNE Therapeutics Reports Second Quarter 2024 Financial Results and Provides Business Update
Rhea-AI Summary
VYNE Therapeutics Inc. (Nasdaq: VYNE) reported its Q2 2024 financial results and provided a business update. Key highlights include:
1. Initiation of a Phase 2b trial for VYN201 in nonsegmental vitiligo, with top-line results expected in mid-2025.
2. Ongoing Phase 1a SAD/MAD trial for VYN202, with data expected in Q3 and Q4 2024.
3. Cash position of $78.1 million as of June 30, 2024, expected to fund operations through the end of 2025.
4. Q2 2024 financial results: Revenue of $0.2 million, R&D expenses of $7.3 million, G&A expenses of $3.3 million, and a net loss of $9.4 million ($0.22 per share).
5. Appointment of Dr. Subhashis Banerjee as Senior VP of Clinical Development.
Positive
- Initiated Phase 2b trial of VYN201 in nonsegmental vitiligo
- Phase 1a SAD/MAD trial of VYN202 progressing as planned
- Strong cash position of $78.1 million, expected to fund operations through end of 2025
- Appointed experienced immunologist Dr. Subhashis Banerjee as Senior VP of Clinical Development
Negative
- Net loss of $9.4 million in Q2 2024
- Slight increase in R&D expenses to $7.3 million
- Marginal increase in G&A expenses to $3.3 million
News Market Reaction
On the day this news was published, VYNE gained 1.17%, reflecting a mild positive market reaction.
Data tracked by StockTitan Argus on the day of publication.
- Initiated Phase 2b trial of VYN201 in nonsegmental vitiligo, with top-line results expected in mid-2025
- Phase 1a SAD/MAD trial of VYN202 progressing, with data from the SAD and MAD portions expected in Q3 and Q4 2024, respectively
- Balance sheet expected to fund key clinical milestones for VYN201 and VYN202 through the end of 2025
BRIDGEWATER, N.J., Aug. 14, 2024 (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 three and six months ended June 30, 2024 and provided a business update.
"We advanced our clinical programs in the second quarter of 2024, highlighted by the initiation of our Phase 2b trial of VYN201 and the Phase 1a trial of VYN202," said David Domzalski, President and Chief Executive Officer of VYNE. "We are pleased with the progress we are making with both clinical programs. We remain on track to report top-line data from our Phase 2b clinical trial for VYN201 in subjects with nonsegmental vitiligo in the middle of next year. We also expect to report top-line data from the single ascending dose portion of the Phase 1a trial of VYN202 this quarter, followed by results from the multiple ascending dose portion in the fourth quarter. Upon the successful completion of this Phase 1a trial, we plan to advance VYN202 into two Phase 1b proof-of-concept trials with top-line readouts in the second half of next year."
Recent Pipeline Updates
VYN201
- VYN201 is a locally administered pan-bromodomain ("BD") BET inhibitor designed as a “soft” drug to address diseases involving multiple, diverse inflammatory cell signaling pathways while providing low systemic exposure. VYNE initiated a Phase 2b trial of VYN201 in nonsegmental vitiligo in June 2024. The Phase 2b trial is a randomized, double-blind, vehicle-controlled trial evaluating the efficacy, safety and pharmacokinetics of once-daily VYN201 gel in three dose cohorts (
1% ,2% and3% concentrations) compared to vehicle for 24 weeks. Subjects are being randomized at 1:1:1:1 ratio. Following the 24-week treatment period, subjects in the1% ,2% , and3% cohorts will continue treatment with their respective dose concentrations for an additional 28-week open label extension. Subjects in the vehicle group during the initial 24-week treatment period will be equally re-randomized to receive VYN2011% ,2% or3% 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
- VYN202 is an oral small molecule BD2-selective BET inhibitor designed to achieve potential class-leading selectivity and potency (BD2 vs. BD1). A first-in-human Phase 1a single ascending dose/multiple ascending dose ("SAD/MAD") trial was initiated in June 2024. VYNE expects to report top-line results from the SAD and MAD portions of the trial in the third and fourth quarters of 2024, respectively. If the Phase 1a trial is successfully completed, VYNE plans to initiate Phase 1b trials in adult subjects with moderate-to-severe plaque psoriasis and moderate-to-severe rheumatoid arthritis, with top-line results anticipated in the second half of 2025.
Recent Corporate Update
- In July, VYNE appointed Subhashis Banerjee, M.D., as Senior Vice President of Clinical Development. Dr. Banerjee is a trained immunologist and rheumatologist with over 25 years of drug development experience at large pharmaceutical companies, including the development of therapies for psoriasis and arthritic conditions. He most recently served as Vice President & Disease Area Head, Rheumatology and Dermatology at Bristol Myers Squibb. Dr. Banerjee played a key role in the development strategy of immunology assets across multiple platforms for several immune-mediated diseases, including SOTYKTU® (deucravacitinib), ORENCIA® (abatacept), clazakizumab (anti-IL-6 antibody), TALTZ® (ixekizumab, anti-IL-17 antibody) and XELJANZ® (tofacitinib).
Upcoming Conference Participation
- H.C. Wainwright 26th Annual Global Investment Conference, September 9-11, 2024, New York, NY
- Stifel Immunology and Inflammation Virtual Summit, September 17-18, 2024
Financial Results as of and for the Second Quarter Ended June 30, 2024
Cash position. As of June 30, 2024, VYNE had cash, cash equivalents, restricted cash and marketable securities of
Revenues. Revenues totaled
Research and development expenses. VYNE’s research and development expenses for the quarter ended June 30, 2024 were
General and administrative expenses. VYNE’s general and administrative expenses for the quarter ended June 30, 2024 were
Net loss. Net loss and net loss per share for the quarter ended June 30, 2024 were
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 VYNE's ability to successfully complete its Phase 1a trial of VYN202, future clinical trials of VYN202, the expected enrollment and timing for reporting top-line results from trials of VYN201 and VYN202, 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.
Third-party products and company names mentioned herein may be the trademarks of their respective owners.
| VYNE THERAPEUTICS INC. CONDENSED CONSOLIDATED BALANCE SHEETS (U.S. dollars in thousands, except share and per share data) (Unaudited) | |||||||
| June 30, | December 31, | ||||||
| 2024 | 2023 | ||||||
| Assets | |||||||
| Current Assets: | |||||||
| Cash and cash equivalents | $ | 29,609 | $ | 30,620 | |||
| Restricted cash | 46 | 54 | |||||
| Investment in marketable securities | 48,492 | 62,633 | |||||
| Prepaid and other current assets | 5,629 | 2,656 | |||||
| Total Current Assets | 83,776 | 95,963 | |||||
| Non-current Assets: | |||||||
| Operating lease right-of-use assets | 151 | 207 | |||||
| Non-current prepaid expenses and other assets | 2,721 | 1,515 | |||||
| Total Non-current Assets | 2,872 | 1,722 | |||||
| Total Assets | $ | 86,648 | $ | 97,685 | |||
| Liabilities and Stockholders’ Equity | |||||||
| Current Liabilities: | |||||||
| Trade payables | $ | 4,516 | $ | 1,659 | |||
| Accrued expenses | 5,069 | 4,119 | |||||
| Employee related obligations | 736 | 1,645 | |||||
| Operating lease liabilities | 120 | 115 | |||||
| Other current liabilities | 1,313 | — | |||||
| Total Current Liabilities | 11,754 | 7,538 | |||||
| Long-term Liabilities: | |||||||
| Non-current operating lease liabilities | 25 | 99 | |||||
| Other liabilities | — | 1,313 | |||||
| Total Long-term Liabilities | 25 | 1,412 | |||||
| Total Liabilities | 11,779 | 8,950 | |||||
| Commitments and Contingencies | |||||||
| Stockholders' Equity: | |||||||
| Preferred stock: | — | — | |||||
| Common stock: | 1 | 1 | |||||
| Additional paid-in capital | 781,917 | 780,044 | |||||
| Accumulated other comprehensive (loss) income | (58 | ) | 26 | ||||
| Accumulated deficit | (706,991 | ) | (691,336 | ) | |||
| Total Stockholders' Equity | 74,869 | 88,735 | |||||
| Total Liabilities and Stockholders’ Equity | $ | 86,648 | $ | 97,685 | |||
| VYNE THERAPEUTICS INC. CONDENSED CONSOLIDATED STATEMENTS OF OPERATIONS (U.S. dollars in thousands, except per share data) (Unaudited) | |||||||||||||||
| Three Months Ended June 30, | Six Months Ended June 30, | ||||||||||||||
| 2024 | 2023 | 2024 | 2023 | ||||||||||||
| Revenues | |||||||||||||||
| Royalty revenues | $ | 198 | $ | 135 | $ | 296 | $ | 234 | |||||||
| Total Revenues | 198 | 135 | 296 | 234 | |||||||||||
| Operating Expenses: | |||||||||||||||
| Research and development | 7,306 | 7,233 | 11,014 | 9,967 | |||||||||||
| General and administrative | 3,288 | 3,220 | 7,058 | 6,460 | |||||||||||
| Total Operating Expenses | 10,594 | 10,453 | 18,072 | 16,427 | |||||||||||
| Operating Loss | (10,396 | ) | (10,318 | ) | (17,776 | ) | (16,193 | ) | |||||||
| Other income, net | 1,001 | 280 | 2,140 | 543 | |||||||||||
| Loss from continuing operations before income taxes | (9,395 | ) | (10,038 | ) | (15,636 | ) | (15,650 | ) | |||||||
| Income tax expense | — | — | — | — | |||||||||||
| Loss from continuing operations | (9,395 | ) | $ | (10,038 | ) | (15,636 | ) | (15,650 | ) | ||||||
| Loss from discontinued operations, net of income taxes | (11 | ) | (20 | ) | (19 | ) | (30 | ) | |||||||
| Net Loss | $ | (9,406 | ) | $ | (10,058 | ) | $ | (15,655 | ) | $ | (15,680 | ) | |||
| Loss per share from continuing operations, basic and diluted | $ | (0.22 | ) | $ | (3.08 | ) | $ | (0.37 | ) | $ | (4.81 | ) | |||
| Income (loss) per share from discontinued operations, basic and diluted | $ | 0.00 | $ | (0.01 | ) | $ | 0.00 | $ | (0.01 | ) | |||||
| Loss per share, basic and diluted | $ | (0.22 | ) | $ | (3.09 | ) | $ | (0.37 | ) | $ | (4.82 | ) | |||
| Weighted average shares outstanding - basic and diluted | 42,586 | 3,274 | 42,584 | 3,265 | |||||||||||
FAQ
What are the key clinical milestones for VYNE Therapeutics (VYNE) in 2024-2025?
What is VYNE Therapeutics' (VYNE) cash position as of Q2 2024?
What were VYNE Therapeutics' (VYNE) Q2 2024 financial results?
What is the status of VYNE Therapeutics' (VYNE) VYN201 clinical trial?
