VYNE Therapeutics Reports Third Quarter 2024 Financial Results and Provides Business Update
VYNE Therapeutics reported Q3 2024 financial results and pipeline updates. The Phase 2b trial of VYN201 for vitiligo is expected to complete enrollment in December 2024, with top-line results anticipated mid-2025. The company reported positive Phase 1a SAD data for VYN202, with MAD data expected in Q4 2024. Financial highlights include cash position of $70.2 million, expected to fund operations through end of 2025. Q3 revenues were $0.1 million, with R&D expenses increasing to $10.2 million. Net loss for Q3 2024 was $12.2 million ($0.29 per share).
VYNE Therapeutics ha riportato i risultati finanziari del terzo trimestre del 2024 e aggiornamenti sul proprio pipeline. Il trial di fase 2b di VYN201 per il vitiligine dovrebbe completare l'arruolamento a dicembre 2024, con i risultati preliminari previsti per metà 2025. L'azienda ha segnalato dati positivi dalla fase 1a di SAD per VYN202, con i dati di MAD attesi nel quarto trimestre del 2024. I punti salienti finanziari includono una posizione di cassa di 70,2 milioni di dollari, prevista per finanziare le operazioni fino alla fine del 2025. I ricavi del terzo trimestre sono stati di 0,1 milioni di dollari, con le spese di R&S aumentate a 10,2 milioni di dollari. La perdita netta per il terzo trimestre del 2024 è stata di 12,2 milioni di dollari (0,29 dollari per azione).
VYNE Therapeutics informó sobre los resultados financieros del tercer trimestre de 2024 y actualizaciones de su pipeline. Se espera que el ensayo de fase 2b de VYN201 para el vitiligo complete la inscripción en diciembre de 2024, con los resultados preliminares anticipados para mediados de 2025. La compañía reportó datos positivos de la fase 1a de SAD para VYN202, con datos de MAD esperados para el cuarto trimestre de 2024. Los aspectos financieros destacados incluyen una posición de efectivo de 70,2 millones de dólares, que se espera financie las operaciones hasta finales de 2025. Los ingresos del tercer trimestre fueron de 0,1 millones de dólares, con gastos de I+D incrementándose a 10,2 millones de dólares. La pérdida neta para el tercer trimestre de 2024 fue de 12,2 millones de dólares (0,29 dólares por acción).
VYNE Therapeutics는 2024년 3분기 재무 결과와 파이프라인 업데이트를 보고했습니다. VYN201의 백반증에 대한 2b상 시험은 2024년 12월에 등록을 완료할 것으로 예상되며, 2025년 중반에 주요 결과가 예상됩니다. 회사는 VYN202에 대한 1a상 SAD의 긍정적인 데이터를 보고했으며, MAD 데이터는 2024년 4분기에 예상됩니다. 재무 요약에는 7020만 달러의 현금 보유량이 포함되어 있으며, 이는 2025년 말까지 운영을 지원할 것으로 기대됩니다. 3분기 수익은 10만 달러였으며, R&D 비용은 1020만 달러로 증가했습니다. 2024년 3분기의 순손실은 1220만 달러 (주당 0.29달러)였습니다.
VYNE Therapeutics a annoncé les résultats financiers du troisième trimestre 2024 et des mises à jour sur son pipeline. L'essai de phase 2b de VYN201 pour le vitiligo devrait achever son inscription en décembre 2024, avec des résultats préliminaires prévus pour mi-2025. La société a rapporté des données positives de la phase 1a sur la SAD pour VYN202, les données de MAD étant attendues au quatrième trimestre 2024. Les points saillants financiers comprennent une position de trésorerie de 70,2 millions de dollars, prévue pour financer les opérations jusqu'à la fin de 2025. Les revenus du troisième trimestre étaient de 0,1 million de dollars, tandis que les dépenses en R&D ont augmenté à 10,2 millions de dollars. La perte nette pour le troisième trimestre 2024 était de 12,2 millions de dollars (0,29 dollar par action).
VYNE Therapeutics hat die finanziellen Ergebnisse des dritten Quartals 2024 und Aktualisierungen zur Pipeline bekannt gegeben. Die Phase-2b-Studie zu VYN201 bei Vitiligo soll im Dezember 2024 die Einschreibung abschließen, mit ersten Ergebnissen, die für Mitte 2025 erwartet werden. Das Unternehmen berichtete von positiven Phase-1a-Daten zur SAD von VYN202, wobei die MAD-Daten für das vierte Quartal 2024 erwartet werden. Zu den finanziellen Highlights gehören eine Zahlungsmittelposition von 70,2 Millionen US-Dollar, die voraussichtlich die Betriebe bis Ende 2025 finanzieren wird. Die Einnahmen im dritten Quartal betrugen 0,1 Millionen US-Dollar, während die F&E-Ausgaben auf 10,2 Millionen US-Dollar anstiegen. Der Nettoverlust für das dritte Quartal 2024 betrug 12,2 Millionen US-Dollar (0,29 US-Dollar pro Aktie).
- Strong cash position of $70.2 million sufficient to fund operations through end of 2025
- VYN201 Phase 2b vitiligo trial showing strong enrollment, indicating market demand
- Positive Phase 1a SAD data for VYN202 with no drug-related adverse events
- Increased R&D expenses by 208.9% to $10.2 million in Q3 2024
- Net loss widened to $12.2 million in Q3 2024
- Minimal revenue generation of only $0.1 million in Q3 2024
Insights
VYNE's Q3 results reveal a significant cash position of
The company's investment in clinical trials, particularly the Phase 2b vitiligo trial and Phase 1a SAD/MAD studies, demonstrates strategic resource allocation toward pipeline development. While operating losses have increased, the strong cash position provides runway for key clinical milestones through 2025, reducing near-term financing risks.
The accelerated enrollment in VYN201's Phase 2b vitiligo trial, exceeding initial targets, signals strong patient and physician interest. The study design, including three dose cohorts (1%, 2% and 3%) with a 24-week treatment period and 28-week extension, is robust and well-structured. VYN202's Phase 1a SAD data showing good tolerability and dose-dependent pharmacodynamic effects on inflammatory biomarkers is promising for potential applications in psoriasis and rheumatoid arthritis.
- VYN201 Phase 2b vitiligo trial exceeds enrollment target; Expected to be fully enrolled in December 2024 with top-line results on track for mid-2025
- Reported positive first-in-human Phase 1a SAD data for VYN202, with MAD data expected in Q4 2024
BRIDGEWATER, N.J., Nov. 07, 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 nine months ended September 30, 2024 and provided a business update.
“We continue to make excellent progress in advancing our two InhiBET™ clinical programs VYN201 and VYN202, and believe each product candidate has the potential to be a differentiated, class-leading therapy for immune-mediated diseases,” said David Domzalski, President and Chief Executive Officer of VYNE. “We recently reported positive SAD data from our Phase 1a SAD/MAD trial of oral, BD2-selective BET inhibitor, VYN202, and we anticipate reporting data from the MAD portion of the trial later this quarter. We are encouraged by the strong enrollment in our ongoing Phase 2b trial for VYN201 which we believe underscores the significant unmet need in the treatment of vitiligo. We expect to complete enrollment next month and report topline data mid- next year.”
Recent Pipeline Updates
VYN201, a locally-administered small molecule pan-BD BET inhibitor:
- Phase 2b trial of VYN201 in nonsegmental vitiligo exceeds initial enrollment target and expected to complete enrollment next month. The Phase 2b trial is expected to be fully enrolled in December 2024, with approximately 40 to 50 subjects per arm. The trial was initiated in June 2024 and VYNE expects to report top-line results from the 24-week double-blind portion of the trial in mid-2025.
- The Phase 2b trial (NCT06493578) 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 equally (1:1:1:1 ratio) across the active drug cohorts or vehicle. Following the 24-week treatment period, subjects who have been randomized in the three dose cohorts will have the option to continue treatment with their respective dose concentrations for an additional 28-week 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:
- VYNE expects to report top-line results from the multiple ascending dose (“MAD”) portion of the Phase 1a trial in the fourth quarter of 2024. Data from the single ascending dose (“SAD”) portion of the trial, announced in September 2024, showed that VYN202 was generally well tolerated with no drug related adverse events. Assessment of key pharmacokinetic and pharmacodynamic parameters demonstrated dose dependent drug concentrations of VYN202 in the blood and showed pharmacodynamic impact of VYN202 on key target-engagement and inflammatory biomarkers in whole blood assays, including an inhibitory effect on select inflammatory biomarkers relevant to psoriasis and rheumatoid arthritis.
- Pending successful completion of the Phase 1a trial, VYNE plans to initiate Phase 1b trials in adult subjects with moderate-to-severe plaque psoriasis and moderate-to-severely active rheumatoid arthritis, with top-line results anticipated in the second half of 2025.
Financial Results as of and for the Third Quarter Ended September 30, 2024
Cash position. As of September 30, 2024, VYNE had cash, cash equivalents, restricted cash and marketable securities of
Share count. As of September 30, 2024, VYNE had 14,751,433 shares issued and outstanding, and outstanding pre-funded warrants to purchase 27,842,740 shares of common stock at an exercise price of
Revenues. Revenues totaled
Research and development expenses. VYNE’s research and development expenses for the quarter ended September 30, 2024 were
General and administrative expenses. VYNE’s general and administrative expenses for both the quarters ended September 30, 2024 and 2023 were approximately
Net loss. Net loss and net loss per share for the quarter ended September 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) | |||||||
| September 30, | December 31, | ||||||
| 2024 | 2023 | ||||||
| Assets | |||||||
| Current Assets: | |||||||
| Cash and cash equivalents | $ | 16,272 | $ | 30,620 | |||
| Restricted cash | 47 | 54 | |||||
| Investment in marketable securities | 53,913 | 62,633 | |||||
| Prepaid and other current assets | 3,303 | 2,656 | |||||
| Total Current Assets | 73,535 | 95,963 | |||||
| Non-current Assets: | |||||||
| Operating lease right-of-use assets | 122 | 207 | |||||
| Non-current prepaid expenses and other assets | 2,541 | 1,515 | |||||
| Total Non-current Assets | 2,663 | 1,722 | |||||
| Total Assets | $ | 76,198 | $ | 97,685 | |||
| Liabilities and Stockholders’ Equity | |||||||
| Current Liabilities: | |||||||
| Trade payables | $ | 3,986 | $ | 1,659 | |||
| Accrued expenses | 6,168 | 4,119 | |||||
| Employee related obligations | 1,071 | 1,645 | |||||
| Operating lease liabilities | 123 | 115 | |||||
| Other current liabilities | 1,313 | — | |||||
| Total Current Liabilities | 12,661 | 7,538 | |||||
| Long-term Liabilities: | |||||||
| Non-current operating lease liabilities | — | 99 | |||||
| Other liabilities | — | 1,313 | |||||
| Total Long-term Liabilities | — | 1,412 | |||||
| Total Liabilities | 12,661 | 8,950 | |||||
| Commitments and Contingencies | |||||||
| Stockholders' Equity: | |||||||
| Preferred stock: | — | — | |||||
| Common stock: | 1 | 1 | |||||
| Additional paid-in capital | 782,650 | 780,044 | |||||
| Accumulated other comprehensive income | 34 | 26 | |||||
| Accumulated deficit | (719,148 | ) | (691,336 | ) | |||
| Total Stockholders' Equity | 63,537 | 88,735 | |||||
| Total Liabilities and Stockholders’ Equity | $ | 76,198 | $ | 97,685 | |||
| 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, | ||||||||||||||
| 2024 | 2023 | 2024 | 2023 | ||||||||||||
| Revenues | |||||||||||||||
| Royalty revenues | $ | 121 | $ | 114 | $ | 417 | $ | 348 | |||||||
| Total Revenues | 121 | 114 | 417 | 348 | |||||||||||
| Operating Expenses: | |||||||||||||||
| Research and development | 10,248 | 3,318 | 21,262 | 13,284 | |||||||||||
| General and administrative | 2,964 | 3,030 | 10,022 | 9,490 | |||||||||||
| Total Operating Expenses | 13,212 | 6,348 | 31,284 | 22,774 | |||||||||||
| Operating Loss | (13,091 | ) | (6,234 | ) | (30,867 | ) | (22,426 | ) | |||||||
| Other income, net | 934 | 163 | 3,074 | 706 | |||||||||||
| Loss from continuing operations before income taxes | (12,157 | ) | (6,071 | ) | (27,793 | ) | (21,720 | ) | |||||||
| Income tax expense | — | — | — | — | |||||||||||
| Loss from continuing operations | (12,157 | ) | (6,071 | ) | (27,793 | ) | (21,720 | ) | |||||||
| Loss from discontinued operations, net of income taxes | — | (513 | ) | (19 | ) | (544 | ) | ||||||||
| Net Loss | $ | (12,157 | ) | $ | (6,584 | ) | $ | (27,812 | ) | $ | (22,264 | ) | |||
| Loss per share from continuing operations, basic and diluted | $ | (0.29 | ) | $ | (1.85 | ) | $ | (0.65 | ) | $ | (6.66 | ) | |||
| Income (loss) per share from discontinued operations, basic and diluted | $ | 0.00 | $ | (0.16 | ) | $ | 0.00 | $ | (0.17 | ) | |||||
| Loss per share, basic and diluted | $ | (0.29 | ) | $ | (2.01 | ) | $ | (0.65 | ) | $ | (6.82 | ) | |||
| Weighted average shares outstanding - basic and diluted | 42,587 | 3,282 | 42,592 | 3,271 | |||||||||||
FAQ
What were VYNE Therapeutics' Q3 2024 financial results?
When will VYNE's VYN201 Phase 2b vitiligo trial results be available?
What is the current status of VYNE's VYN202 clinical program?
