10/15/2025 | Press release | Distributed by Public on 10/15/2025 06:00
Binding Memorandum of Understanding for Amendment to Exclusive License Agreement with GSK
On October 14, 2025, SCYNEXIS, Inc. ("SCYNEXIS") and GlaxoSmithKline Intellectual Property (No. 3) Limited ("GSK") entered into a binding memorandum of understanding (the "Binding 2025 MOU") for amendment to the exclusive license agreement between SCYNEXIS and GSK, dated March 30, 2023, as amended by a binding memorandum of understanding on December 26, 2023 (the "Binding 2023 MOU") (the exclusive license agreement and Binding 2023 MOU, together with the associated Transitional Manufacturing and Supply Agreement, the "Exclusive License Agreement"). Pursuant to the terms of the Exclusive License Agreement, SCYNEXIS granted GSK an exclusive (even as to SCYNEXIS and its affiliates), royalty-bearing, sublicensable license for the development, manufacture, and commercialization of ibrexafungerp, including the approved product BREXAFEMME®, for all indications, in all countries other than Greater China and certain other countries already licensed to third parties. The terms of the Exclusive License Agreement are further described in SCYNEXIS's Current Reports on Form 8-K filed with the Securities and Exchange Commission on March 30, 2023 and January 2, 2024.
As previously disclosed, there was a disagreement between SCYNEXIS and GSK regarding the Phase 3 MARIO study of ibrexafungerp for the treatment of invasive candidiasis (the "MARIO Study"). The parties have now resolved the disagreement as detailed in the Binding 2025 MOU, pursuant to which SCYNEXIS has agreed to promptly wind-down and terminate the MARIO Study and will receive a $22 million payment from GSK. SCYNEXIS will not receive any additional milestone payments from GSK specifically associated with the MARIO Study but will receive an additional $2.3 million payment from GSK in connection with the wind-down and termination activities.
GSK has reiterated its commitment to continued collaboration with SCYNEXIS regarding other aspects of the Exclusive License Agreement, including with respect to the commercialization of BREXAFEMME®(ibrexafungerp tablets) for the vulvovaginal candidiasis (VVC) and refractory vulvovaginal candidiasis (rVVC) indications. SCYNEXIS continues to progress the transfer of the BREXAFEMME NDA to GSK by the end of 2025. GSK anticipates being able to initiate regulatory interactions with the U.S. Food and Drug Administration (FDA) in 2026 to discuss the relaunch of BREXAFEMME for VVC and rVVC in the U.S. market.
Except as described above with respect to the MARIO Study, the Binding 2025 MOU does not alter the potential milestones and royalties payable to SCYNEXIS under the Exclusive License Agreement, including with regard to sales of BREXAFEMME for VVC and rVVC.
The foregoing is only a summary of the material terms of the Binding 2025 MOU and does not purport to be a complete description of the rights and obligations of the parties thereunder and is qualified in its entirety by reference to the Binding 2025 MOU, a copy of which SCYNEXIS intends to file with its Annual Report on Form 10-K for the year ending December 31, 2025, requesting confidential treatment for certain portions thereof.