Company: SCYX
Filing Date: 2025-08-13
Form Type: 10-Q
Source: 0000950170-25-107985
Chunk: 12

Company: SCYNEXIS INC
Filing Date: 2025-08-13
Form: 10-Q
Item: Part I, Item 8
Chunk 12
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 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 the Company 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 the study. The Company does not believe that GSK currently has the right to unilaterally terminate the MARIO study under the GSK License Agreement.The GSK License Agreement provides that certain material changes to the study, including termination, require mutual written agreement of both parties. The Company has not provided such agreement. The GSK License Agreement only provides GSK with a unilateral termination right in the event that dosage of the first new patient in MARIO had not occurred by a particular date. The date was set as April 26, 2025, subject to automatic extension of up to two months, or June 26, 2025, if the implementation of additional in process control method validation was included in the amended IND or required by GSK, resulting in additional time in the manufacturing process. The Company is seeking to resolve this disagreement with GSK. Meanwhile, the Company reinitiated the MARIO study and patient dosing resumed in the Phase 3 MARIO study in May 2025, triggering the Company to bill a $10.0 million development milestone to GSK in the three months ended June 30, 2025.  The Company is seeking to collect its development milestones from GSK and ultimately complete the study. The Company remains committed to developing novel antifungal solutions to the rising threat of deadly fungal infections including invasive candidiasis for which there are limited treatment options and significant concerns for emergence of resistances, as highlighted by the WHO in their call to industry and other parties for research, development and public health action in this area of unmet need.  The Company had an accumulated deficit of $388.8 million at June 30, 2025.  The Company's capital resources primarily comprised cash and cash equivalents and investments of $46.5 million at June 30, 2025. While the Company believes its capital resources are sufficient to fund the Company’s on-going operations for a period of at least 12 months subsequent to the