Company: SCYX
Filing Date: 2025-08-13
Form Type: 10-Q
Source: 0000950170-25-107985
Chunk: 5

Company: SCYNEXIS INC
Filing Date: 2025-08-13
Form: 10-Q
Item: Part I, Item 2
Chunk 5
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 Blastomyces genera and most common mucorales species. 

Ibrexafungerp is the first representative of this novel class of antifungals and was approved by the U.S. Food and Drug Administration (FDA) as BREXAFEMME (ibrexafungerp tablets) for treatment of patients with vulvovaginal candidiasis and for the reduction in the incidence of recurrent vulvovaginal candidiasis in 2021 and 2022, respectively. Oral ibrexafungerp is also under development for other systemic fungal diseases.  

 A second generation fungerp SCY-247 is currently being evaluated in clinical trials with additional compounds from our proprietary fungerp platform, targeted to address significant unmet needs, in earlier stages of development.

Oral ibrexafungerp is also under development for other systemic fungal diseases.  

MARIO Study and Clinical Hold Update

As previously disclosed, we and GlaxoSmithKline Intellectual Property (No. 3) Limited (GSK) entered into an exclusive license agreement dated March 30, 2023, which was subsequently amended by a binding memorandum of understanding dated December 26, 2023 (collectively, the GSK License Agreement).

As previously disclosed, the Phase 3 MARIO study of ibrexafungerp for the treatment of invasive candidiasis was placed on clinical hold in September 2023 following identification of a potential cross-contamination at the facility of the drug substance manufacturer in light of draft FDA guidance recommending that certain drugs be manufactured in separate facilities. One of these drugs, a non-antibiotic beta lactam drug called ezetimibe, was being manufactured at the same facility as ibrexafungerp. We have since moved the manufacture of the clinical supplies of ibrexafungerp to enable the continuation of the MARIO study to a new facility.  

On April 24, 2025, the FDA notified us that the clinical hold on ibrexafungerp had been lifted and concluded that the Phase 3 MARIO study could resume. Subsequently, on April 28, 2025, GSK notified us of their intention to immediately terminate the study based on its purported rights under the GSK License Agreement to unilaterally terminate the MARIO study. GSK claimed that, as a result, it would have no obligations to pay any further development milestones related to the MARIO study, including $30.0 million tied to the resumption and continuation of