SCYNEXIS Reports Third Quarter 2025 Financial Results and Provides Corporate Update
SCYNEXIS (NASDAQ: SCYX) reported Q3 2025 results and a corporate update on Nov 5, 2025. The company will receive a one-time payment of $24.8 million from GSK related to termination of the Phase 3 MARIO study and expects a post-payment cash runway of greater than two years.
SCYNEXIS reported $37.9 million in cash, cash equivalents and investments as of Sept 30, 2025, net loss of $8.6 million (Q3 2025) and plans to start an IV Phase 1 for SCY-247 in Q1 2026 and a Phase 2 oral study with proof-of-concept data expected in 2026. GSK is pursuing a BREXAFEMME relaunch and SCYNEXIS may receive up to $146 million in annual net sales milestones plus low-to-mid single-digit royalties.
SCYNEXIS (NASDAQ: SCYX) ha pubblicato i risultati del terzo trimestre 2025 e un aggiornamento aziendale il 5 novembre 2025. L'azienda riceverà un pagamento una tantum di 24,8 milioni di dollari da GSK relativo alla terminazione dello studio di fase 3 MARIO e si aspetta una disponibilità di cassa post pagamento superiore a due anni.
SCYNEXIS ha riportato 37,9 milioni di dollari in cassa, equivalenti di cassa e investimenti al 30 settembre 2025, una perdita netta di 8,6 milioni di dollari (Q3 2025) e prevede di avviare una Fase 1 endovena per SCY-247 nel Q1 2026 e uno studio di Fase 2 orale con dati di proof-of-concept attesi nel 2026. GSK sta perseguendo un rilancio di BREXAFEMME e SCYNEXIS potrebbe ricevere fino a 146 milioni di dollari in traguardi di vendite nette annuali, oltre a royalty a cifra singola bassa-medio.
SCYNEXIS (NASDAQ: SCYX) reportó resultados del tercer trimestre de 2025 y una actualización corporativa el 5 de noviembre de 2025. La compañía recibirá un pago unico de 24,8 millones de dólares por parte de GSK relacionado con la terminación del estudio de Fase 3 MARIO y espera una liquidez post-pago de más de dos años.
SCYNEXIS reportó 37,9 millones de dólares en efectivo, equivalentes de efectivo e inversiones al 30 de septiembre de 2025, una pérdida neta de 8,6 millones de dólares (Q3 2025) y planea iniciar una Fase 1 IV para SCY-247 en el Q1 de 2026 y un estudio oral de Fase 2 con datos de prueba de concepto esperados en 2026. GSK está buscando relanzar BREXAFEMME y SCYNEXIS podría recibir hasta 146 millones de dólares en hitos de ventas netas anuales, además de regalías de rango bajo a medio de una cifra singular.
SCYNEXIS (NASDAQ: SCYX) 는 2025년 11월 5일 2025년 3분기 실적 및 기업 업데이트를 발표했다. 이 회사는 3상 MARIO 연구 종료와 관련하여 GSK로부터 2480만 달러의 일시 지급을 받을 것이며 지급 이후 현금 운용 기간은 2년 이상으로 예상된다.
SCYNEXIS는 2025년 9월 30일 기준 현금, 현금성 자산 및 투자에서 3790만 달러를 보유했고, 3분기 순손실은 860만 달러이며(2025년 Q3) 2026년 1분기에 SCY-247의 IV 1상 시작과 2026년에 예비 개념 검증 데이터가 기대되는 경구 2상 연구를 계획하고 있다. GSK는 BREXAFEMME 재런칭을 추진 중이며 SCYNEXIS는 연간 순매출 이정표로 최대 1억 4600만 달러를, 저-중단의 단일 자릿수 로열티를 받을 수 있다.
SCYNEXIS (NASDAQ: SCYX) a publié les éjoupe des troisièmes trimestre 2025 et une mise à jour dés le 5 novembre 2025. L’entreprise recevra un paiement unique de 24,8 millions de dollars de GSK relatif à la termination de l’étude de phase 3 MARIO et s’attend à une liquidité post-paiement de plus de deux ans.
SCYNEXIS a annoncé 37,9 millions de dollars en cash, disponibilités et investissements au 30 septembre 2025, une perte nette de 8,6 millions de dollars (T3 2025) et prévoit de lancer une phase 1 IV pour SCY-247 au 1er trimestre 2026 et une phase 2 orale avec des données de preuve de concept attendues en 2026. GSK envisage relancer BREXAFEMME et SCYNEXIS pourrait percevoir jusqu’à 146 millions de dollars en jalons de ventes nettes annuelles, plus des royalties à faible à moyen chiffre.
SCYNEXIS (NASDAQ: SCYX) meldete die Ergebnisse des dritten Quartals 2025 sowie ein Unternehmensupdate am 5. November 2025. Das Unternehmen wird eine Einmalzahlung von 24,8 Millionen US-Dollar von GSK im Zusammenhang mit der Beendigung der Phase-3-Studie MARIO erhalten und rechnet mit einer nach der Zahlung verbleibenden bilanziellen Laufzeit von mehr als zwei Jahren.
SCYNEXIS meldete 37,9 Millionen US-Dollar an Bargeld, Zahlungsmitteln und Investitionen zum Stichtag 30. September 2025, einen Nettoverlust von 8,6 Millionen US-Dollar (Q3 2025) und plant, eine IV-Phase-1-Studie für SCY-247 im ersten Quartal 2026 zu beginnen sowie eine oralen Phase-2-Studie mit Proof-of-Concept-Daten, die voraussichtlich im 2026 vorliegen, durchzuführen. GSK verfolgt einen BREXAFEMME-Neu-Start und SCYNEXIS könnte bis zu 146 Millionen US-Dollar an jährlichen Netto-Umsatz-Meilensteinen sowie Royalties im unteren bis mittleren einstelligen Bereich erhalten.
SCYNEXIS (بورصة ناسداك: SCYX) أَصدرت نتائج الربع الثالث من 2025 وتحديثاً للشركة في 5 نوفمبر 2025. ستتلقى الشركة دفعة لمرة واحدة قدرها 24.8 مليون دولار أمريكي من GSK تتعلق بإنهاء تجربة المرحلة 3 MARIO وتتوقع وجوداً نقدياً بعد الدفع لأكثر من سنتين.
أفادت SCYNEXIS بأن لديها 37.9 مليون دولار من النقد وما يعادله من النقد والاستثمارات حتى 30 سبتمبر 2025، وخسارة صافية قدرها 8.6 مليون دولار (الربع الثالث من 2025)، وتخطط لبدء تجربة المرحلة 1 الوريدية لـ SCY-247 في الربع الأول من 2026 وتجربة فاعلية فموية من المرحلة 2 مع بيانات إثبات المفهوم المتوقع الحصول عليها في 2026. تسعى GSK لإعادة إطلاق BREXAFEMME وربما تتلقى SCYNEXIS حتى 146 مليون دولار كمعالم مبيعات صافية سنوية بالإضافة إلى عوائد بمعدلات أحادية منخفضة إلى متوسطة.
- $24.8M one-time payment from GSK
- Cash runway > 2 years after Q4 2025 payment
- Plan to initiate IV Phase 1 of SCY-247 in Q1 2026
- Phase 2 proof-of-concept data for SCY-247 expected in 2026
- Q3 2025 net loss $8.6M vs $2.8M prior year
- Cash, cash equivalents and investments down to $37.9M from $75.1M at 2024 year-end
- Revenue declined to $0.3M in Q3 2025 from $0.7M in Q3 2024
- Q3 2025 fair value adjustment loss on warrants of $0.6M
Insights
Positive: cash boost from GSK plus Phase 1 win for SCY-247 supports near‑term clinical milestones and a multi‑year runway.
The company secured a one‑time payment of
Clinical progress on SCY‑247 is concrete: positive SAD/MAD data showed target exposures at lower doses than the first‑generation compound and no dose‑limiting toxicities, which justifies the planned IV and oral studies. Key dependencies and risks include successful execution of the IV formulation study, enrollment and endpoints in the invasive candidiasis Phase 2, and whether non‑dilutive funding is secured; none of these are guaranteed by the disclosed facts.
Watch for three near‑term, monitorable items: initiation of the IV Phase 1 in
- SCYNEXIS to receive one-time payments totalling
$24.8 million from GSK as part of the resolution of the disagreement related to the restart of the Phase 3 MARIO study in invasive candidiasis. Scynexis agreed to GSK’s request to terminate the study. - Following the positive SAD/MAD data results announced in September for SCY-247, its second-generation fungerp, the Company expects to initiate a Phase 1 study with the IV formulation and a Phase 2 study for the treatment of invasive candidiasis. The Company aims to release clinical proof of concept data in invasive candidiasis in 2026 and is exploring non-dilutive funding opportunities to support the development of SCY-247.
- GSK remains committed to the relaunch of BREXAFEMME® with activities ongoing to transfer the NDA before the end of the year. Following the relaunch, SCYNEXIS stands to receive up to approximately
$146 million in annual net sales milestones as well as royalties net of payments to Merck, in the low to mid single digit range. - SCYNEXIS ended Q3 2025 with cash, cash equivalents and investments of
$37.9 million ; after receiving the one-time payments of$24.8 million from GSK in Q4 of 2025, the company’s cash runway will be greater than two years.
JERSEY CITY, N.J., Nov. 05, 2025 (GLOBE NEWSWIRE) -- SCYNEXIS, Inc. (NASDAQ: SCYX), a biotechnology company pioneering innovative medicines to overcome and prevent difficult-to-treat and drug-resistant infections, today reported financial results for the third quarter ended September 30, 2025.
“Over the last several weeks, SCYNEXIS realized two significant achievements that we believe position our company for significant growth and success,” said David Angulo, M.D., President and Chief Executive Officer. “First, we announced the positive SAD/MAD data for our second-generation fungerp drug candidate, SCY-247, demonstrating that orally administered SCY-247 was well tolerated and achieved the estimated efficacy exposure at doses lower than the first generation fungerp (ibrexafungerp). We are excited about the favorable tolerability and pharmacokinetics of SCY-247 and look forward to commencing a Phase 2 study in invasive candidiasis, aiming to release proof of concept data in 2026. Secondly, we announced a successful resolution of our disagreement with GSK, which led to the one time payments of
Ibrexafungerp / GSK Update
- On October 15, 2025, the Company announced that it would receive a one-time payment of
$24.8 million from GlaxoSmithKline Intellectual Property (No. 3) Limited (GSK) as part of a resolution of the disagreement with GSK related to the restart of the Phase 3 MARIO study on invasive candidiasis. SCYNEXIS also announced that it would promptly commence appropriate wind-down activities associated with the termination of the MARIO study.
SCY-247 Development Program
- On September 30, 2025, the Company announced positive results from a Phase 1 SAD/MAD study of SCY-247, its second-generation triterpenoid antifungal under development for the treatment and prevention of invasive fungal infections with the potential to provide the therapeutic advantages of both an oral and IV formulation.
- SCY-247 was generally well tolerated with no dose limiting toxicities observed
- SCY-247 was able to achieve target exposures at doses lower than our first-generation fungerp
- Safety, tolerability, and pharmacokinetic profile support the continued clinical development of SCY-247
- After positive Phase 1 data, the Company intends to progress the development of SCY-247 towards addressing significant unmet needs in the antifungal space that also represent attractive commercial opportunities. SCYNEXIS anticipates initiating a Phase 1 study with the intravenous (IV) formulation of SCY-247 in Q1 2026. The clinical proof-of-concept Phase 2 study is planned to start using the oral formulation of SCY-247 in patients with invasive candidiasis and subsequent stages of development are anticipated to include studies adequate to support an invasive candidiasis treatment indication, as well as evaluating SCY-247 for the prevention of invasive fungal diseases in patients at high risk. Phase 2 proof-of-concept data are expected to be available in 2026. The Company is exploring non-dilutive funding opportunities to support the development of SCY-247.
- On September 4, 2025, SCYNEXIS announced multiple presentations highlighting data on the Company’s second-generation fungerp drug candidate, SCY-247, at the 12th Congress on Trends in Medical Mycology (TIMM-12), which took place from September 19th to 22nd, 2025, in Bilbao, Spain.
- An oral presentation featured data demonstrating SCY-247 in vitro activity against C. auris strains, including isolates with mutations commonly associated with echinocandin-resistance
- Additional poster presentations highlighted SCY-247’s broad spectrum of antifungal activity, against Candida species, including multidrug- and pandrug-resistant C. auris and Aspergillus species.
Third Quarter 2025 Financial Results
For the three months ended September 30, 2025 and 2024, revenue primarily consisted of
Research and development expenses for the three months ended September 30, 2025, was
Selling, general and administrative expenses for the three months ended September 30, 2025, increased to
Total other expense was
Net loss for the three months ended September 30, 2025 was
Cash Balance
Cash, cash equivalents and investments totaled
About Triterpenoid Antifungals
Triterpenoid antifungals (also known as “fungerps”) are a novel class of structurally distinct glucan synthase inhibitors that combine the well-established activity of glucan synthase inhibitors with the potential flexibility of having oral and intravenous (IV) formulations. They have demonstrated broad-spectrum antifungal activity against multidrug-resistant pathogens, including azole- and echinocandin-resistant strains. Ibrexafungerp is the first representative of this novel class of antifungal agents. Ibrexafungerp, formerly known as SCY-078, is currently approved in the U.S. for the treatment of vulvovaginal candidiasis. The next generation fungerp, SCY-247, is currently in Phase 1 stage of clinical development. Additional analogs of the fungerp class of compunds are in pre-clinical stages of development.
About SCYNEXIS
SCYNEXIS, Inc. (NASDAQ: SCYX) is a biotechnology company pioneering innovative medicines to help millions of patients worldwide overcome and prevent difficult-to-treat infections that are becoming increasingly drug-resistant. SCYNEXIS is developing the company’s proprietary antifungal platform “fungerps.” Ibrexafungerp, the first representative of this novel class, has been licensed to GSK. The U.S. Food and Drug Administration (FDA) has approved BREXAFEMME® (ibrexafungerp tablets) for the treatment of vulvovaginal candidiasis (VVC) and for reduction in the incidence of recurrent VVC. Additional antifungal assets from this novel class are currently in clinical, pre-clinical and discovery phases, including the compound SCY-247. For more information, visit www.scynexis.com.
Forward-Looking Statements
Statements contained in this press release regarding expected future events or results are "forward-looking statements" within the meaning of the Private Securities Litigation Reform Act of 1995, including but not limited to statements regarding: any advantages of SCY-247 over existing antifungals, continued development of SCY-247, receipt of milestones and royalties from GSK, and the Company’s cash runway. Because such statements are subject to risks and uncertainties, actual results may differ materially from those expressed or implied by such forward-looking statements. These risks and uncertainties include, but are not limited to, risks inherent in regulatory and other costs in developing products. These and other risks are described more fully in SCYNEXIS' filings with the Securities and Exchange Commission, including without limitation, its most recent Annual Report on Form 10-K filed on March 12, 2025, including under the caption "Risk Factors." All forward-looking statements contained in this press release speak only as of the date on which they were made. SCYNEXIS undertakes no obligation to update such statements to reflect events that occur or circumstances that exist after the date on which they were made.
CONTACT:
Investor Relations
Irina Koffler
LifeSci Advisors
Tel: 917-734-7387
ikoffler@lifesciadvisors.com
| SCYNEXIS, INC. | ||||||||
| UNAUDITED CONDENSED CONSOLIDATED BALANCE SHEETS | ||||||||
| (in thousands, except share and per share data) | ||||||||
| September 30, 2025 | December 31, 2024 | |||||||
| Assets | ||||||||
| Current assets: | ||||||||
| Cash and cash equivalents | $ | 14,797 | $ | 16,051 | ||||
| Short-term investments | 23,131 | 43,249 | ||||||
| Prepaid expenses and other current assets | 686 | 2,184 | ||||||
| License agreement receivable | 10,000 | 753 | ||||||
| License agreement contract asset | — | 9,509 | ||||||
| Restricted cash | 80 | 435 | ||||||
| Total current assets | 48,694 | 72,181 | ||||||
| Investments | — | 15,846 | ||||||
| Deferred offering costs | 417 | 417 | ||||||
| Restricted cash | 109 | 109 | ||||||
| Operating lease right-of-use asset | 1,851 | 2,090 | ||||||
| Total assets | $ | 51,071 | $ | 90,643 | ||||
| Liabilities and stockholders’ equity | ||||||||
| Current liabilities: | ||||||||
| Accounts payable | $ | 3,467 | $ | 4,569 | ||||
| Accrued expenses | 2,774 | 3,793 | ||||||
| Deferred revenue, current portion | 1,765 | 1,642 | ||||||
| Operating lease liability, current portion | 463 | 407 | ||||||
| Convertible debt | — | 13,688 | ||||||
| Total current liabilities | 8,469 | 24,099 | ||||||
| Deferred revenue | 807 | 1,294 | ||||||
| Warrant liability | 3,544 | 7,998 | ||||||
| Operating lease liability | 1,821 | 2,175 | ||||||
| Total liabilities | 14,641 | 35,566 | ||||||
| Commitments and contingencies | ||||||||
| Stockholders’ equity: | ||||||||
| Preferred stock, | — | — | ||||||
| Common stock, | 45 | 41 | ||||||
| Additional paid-in capital | 433,787 | 431,571 | ||||||
| Accumulated deficit | (397,402 | ) | (376,535 | ) | ||||
| Total stockholders’ equity | 36,430 | 55,077 | ||||||
| Total liabilities and stockholders’ equity | $ | 51,071 | $ | 90,643 | ||||
| SCYNEXIS, INC. | ||||||||
| UNAUDITED CONDENSED CONSOLIDATED STATEMENTS OF OPERATIONS | ||||||||
| (in thousands, except share and per share data) | ||||||||
| Three Months Ended September 30, | ||||||||
| 2025 | 2024 | |||||||
| License agreement revenue | $ | 334 | $ | 660 | ||||
| Operating expenses: | ||||||||
| Research and development | 5,452 | 8,073 | ||||||
| Selling, general and administrative | 3,287 | 2,907 | ||||||
| Total operating expenses | 8,739 | 10,980 | ||||||
| Loss from operations | (8,405 | ) | (10,320 | ) | ||||
| Other (income) expense: | ||||||||
| Amortization of debt issuance costs and discount | — | 441 | ||||||
| Interest income | (454 | ) | (1,020 | ) | ||||
| Interest expense | — | 213 | ||||||
| Warrant liability fair value adjustment | 640 | (6,751 | ) | |||||
| Derivative liability fair value adjustment | — | — | ||||||
| Total other expense (income) | 186 | (7,117 | ) | |||||
| Loss before taxes | (8,591 | ) | (3,203 | ) | ||||
| Income tax (benefit) expense | — | (395 | ) | |||||
| Net loss | $ | (8,591 | ) | $ | (2,808 | ) | ||
| Net loss per share – basic and diluted | $ | (0.17 | ) | $ | (0.06 | ) | ||
| Weighted average common shares outstanding – basic and diluted | 49,898,892 | 48,618,693 | ||||||