SCYNEXIS to Receive $10 Million Milestone Payment from GSK Triggered by Delivery of Completed FURI, CARES and NATURE Clinical Study Reports

Rhea-AI Summary

SCYNEXIS (NASDAQ: SCYX) announced it will receive a $10 million milestone payment from GSK, triggered by the delivery of final clinical study reports for the completed FURI, CARES, and NATURE trials. This payment is part of their exclusive license agreement for ibrexafungerp. Results from the FURI and CARES studies are positive and consistent with previous interim analyses. SCYNEXIS reiterates its cash runway of over two years and plans to advance SCY-247, its next-generation fungerp, into clinical trials later this year. The company has previously received $115 million from GSK and is eligible for up to $323 million more in potential payments, plus tiered royalties on ibrexafungerp sales.

Positive

• Receiving $10 million milestone payment from GSK
• Positive results from FURI and CARES studies
• Cash runway exceeding two years
• Potential for additional $323 million in milestone payments from GSK
• Eligibility for tiered royalties on ibrexafungerp sales

Negative

• Ongoing supply chain issues for ibrexafungerp
• Delay in restarting Phase 3 MARIO study in invasive candidiasis

Reiterating cash runway of > 2 years

JERSEY CITY, N.J., July 23, 2024 (GLOBE NEWSWIRE) -- SCYNEXIS, Inc. (NASDAQ: SCYX), a biotechnology company pioneering innovative medicines to overcome and prevent difficult-to-treat and drug-resistant infections, today announced that it will receive a $10 million development milestone payment under its exclusive license agreement with GSK for ibrexafungerp. The milestone payment is triggered by the delivery of final clinical study reports for the completed FURI, CARES, and NATURE clinical studies.

"We are pleased to have completed these important studies in refractory invasive fungal infections, for which there remains an urgent need to deliver new solutions and combat growing resistance," said David Angulo, M.D., President and Chief Executive Officer of SCYNEXIS. "Work continues to reestablish the supply chain of ibrexafungerp, and we look forward to restarting the Phase 3 MARIO study in invasive candidiasis. Our balance sheet remains robust, and our cash runway exceeds two years as we advance our next generation fungerp, SCY-247, into the clinic later this year."

Results from the open-label studies of ibrexafungerp in patients with refractory or resistant fungal diseases (FURI) and in patients with Candidiasis caused by Candida auris (CARES) are positive and consistent with previously announced interim analyses and are expected to be presented at a future scientific meeting. NATURE was an observational study to evaluate the outcome of patients with invasive candidiasis treated with available standard of care options and was designed as an external control strategy for the FURI study.

SCYNEXIS anticipates receiving the $10 million milestone payment in the third quarter of 2024. Under the terms of the exclusive license agreement with GSK, SCYNEXIS had previously received $115 million in upfront and development milestone payments and is eligible to receive up to an additional $323 million in potential development, regulatory and commercial milestone-based payments for a total deal value of $448 million. GSK will also pay mid-single digit to mid-teen digit tiered royalties on the totality of ibrexafungerp sales across all indications.

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) approved BREXAFEMME^® (ibrexafungerp tablets) in June 2021, for its first indication in vulvovaginal candidiasis (VVC), followed by a second indication in November 2022, for reduction in the incidence of recurrent VVC. Late-stage clinical investigation of ibrexafungerp for the treatment of life-threatening invasive fungal infections in hospitalized patients is ongoing. Additional antifungal assets from this novel class are currently in pre-clinical and discovery phase, 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: SCYNEXIS’s expectation that it will have a cash runway of more than two years; anticipated advancement of SCY-247 into the clinic in 2024; and the resumption of the MARIO study. 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 28, 2024, and form 10-Q for the quarter ending March 31, 2024, 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: (646) 970-4681
ikoffler@lifesciadvisors.com

FAQ

What milestone triggered the $10 million payment from GSK to SCYNEXIS (SCYX)?

The $10 million payment was triggered by SCYNEXIS delivering final clinical study reports for the completed FURI, CARES, and NATURE clinical studies of ibrexafungerp.

What were the results of the FURI and CARES studies for SCYNEXIS (SCYX)?

The results from the FURI and CARES studies of ibrexafungerp were positive and consistent with previously announced interim analyses. Detailed results are expected to be presented at a future scientific meeting.

When does SCYNEXIS (SCYX) plan to advance SCY-247 into clinical trials?

SCYNEXIS plans to advance SCY-247, its next-generation fungerp, into clinical trials later in 2024.

What is the total potential value of the license agreement between SCYNEXIS (SCYX) and GSK for ibrexafungerp?

The total potential value of the agreement is $448 million, including $115 million already received, the current $10 million payment, and up to $323 million in additional potential milestone payments.