Material Event (Form 8-K)

Item 8.01 Other Events

The Company intends to submit an application for a Commissioner's National Priority Review Voucher if the outcome of any interim and/or final analysis of the Company's randomized, placebo-controlled trial of tafenoquine in patients hospitalized with severe babesiosis supports moving forward with a New Drug Application submission to the U.S. Food and Drug Administration ("FDA") before the end of the first quarter of 2028. The Company is providing this disclosure to inform investors regarding its current development and regulatory plans. The Company's expectations regarding the trial, any future NDA submission, and any potential voucher application are forward-looking statements and are subject to risks and uncertainties, including the outcome of clinical development, interactions with regulatory authorities, and other factors that could cause actual results to differ materially from those anticipated.

Cautionary Statement Regarding Forward-Looking Statements

This Current Report on Form 8-K includes forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. Such statements involve risks and uncertainties that could cause the Company's actual results and financial position to differ materially. These risks and uncertainties include uncertainties associated with market conditions and other risks described under the heading "Risk Factors" in the Company's SEC Filings on Form 10-K and Form 10-Q. The Company assumes no responsibility to update or revise any forward-looking statements to reflect events, trends or circumstances after the date hereof.