SCYNEXIS Reports Closing of Exclusive License Agreement with GSK for BREXAFEMME® (Ibrexafungerp Tablets)

  • SCYNEXIS is receiving an upfront payment of $90 million with future performance-based milestone payments of up to $503 million and tiered royalties.
  • GSK obtains the exclusive rights to ibrexafungerp; SCYNEXIS retains rights to all other assets in its proprietary class of enfumafungin-derived antifungal compounds (“fungerps”), currently in preclinical development.

JERSEY CITY, N.J., May 12, 2023 (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 the closing of its previously announced exclusive license agreement with GSK plc (LSE/NYSE: GSK) to commercialize the novel antifungal BREXAFEMME® (ibrexafungerp tablets) as a treatment for vulvovaginal candidiasis (VVC) and further develop ibrexafungerp for multiple indications in invasive and life-threatening fungal diseases.

Under the terms of the agreement, GSK will make an upfront payment to SCYNEXIS of $90 million, plus additional potential milestone-based payments totaling up to $503 million. GSK will also pay mid-single digit to mid-teen digit tiered royalties on the totality of sales across all indications. Further information regarding the financial terms of the agreement can be found in SCYNEXIS’s SEC filings.

GSK has the rights to develop ibrexafungerp and commercialize BREXAFEMME in all countries except the greater China region and certain other countries already out-licensed by SCYNEXIS to third parties. Under the license agreement, SCYNEXIS will continue executing the Phase 3 program for invasive candidiasis (IC) and other ongoing trials.

SCYNEXIS retains rights to all other assets in its proprietary class of enfumafungin-derived antifungal compounds (“fungerps”), which are currently in preclinical development for the treatment of life-threating invasive fungal diseases. As part of this exclusive license agreement, GSK has been granted a right of first negotiation to these compounds.

About BREXAFEMME® (ibrexafungerp tablets)

BREXAFEMME® (ibrexafungerp tablets) is a novel oral glucan synthase inhibitor with a broad spectrum of activity including against emerging resistant threats. Its mechanism of action is similar to echinocandins, with fungicidal action against yeast (meaning it kills the fungus), versus fluconazole which is fungistatic (meaning it inhibits fungal growth). It was first approved in the U.S. in 2021 for the treatment of VVC and is the first and only oral antifungal approved for both the treatment of VVC and the reduction of the incidence of RVVC. BREXAFEMME has proven activity against WHO-designated priority fungal pathogens such as Candida albicans. In addition, ibrexafungerp has shown activity against Candida auris, another WHO-designated priority fungal pathogen.

Prescribing information is available here.

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 its proprietary class of enfumafungin-derived antifungal compounds (“fungerps") as broad-spectrum, systemic antifungal agents for multiple fungal indications. The U.S. Food and Drug Administration (FDA) approved the first representative of this antifungal class, 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 is ongoing. Additional assets in the novel “fungerp” class of antifungals 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. 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 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 and Quarterly Report on Form 10-Q, including in each case under the caption "Risk Factors," and in other documents subsequently filed with or furnished to the Securities and Exchange Commission. 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

Media Relations
Debbie Etchison
SCYNEXIS
debbie.etchison@scynexis.com


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Source: Scynexis