Material Event (Form 8-K)

Item 8.01 Other Events.

As previously announced on June 3, 2025, the Company and Zydus Pharmaceuticals (USA) Inc. entered agreements pursuant to which, (i) under an asset purchase agreement Zydus will acquire assets comprising the Company's manufacturing operations, (ii) under a stock purchase agreement Zydus will acquire a minority position in the Company and (iii) under a license agreement Zydus will receive certain commercial rights in India and Sri Lanka relating to intellectual property associated with BOT/BOL. The Company and Zydus jointly submitted a filing to the Committee on Foreign Investment in the United States (CFIUS) to commence the CFIUS review process.

On September 17, 2025, CFIUS requested that the Company and Zydus voluntarily submit a full notice application with CFIUS related to the transactions.

Based on the anticipated CFIUS review time related to the full notice filing the anticipated closing of these transactions has now shifted to the fourth quarter of 2025.

More detailed descriptions of the asset purchase agreement and stock purchase agreement are contained in our Current Report on Form 8-K filed with the SEC on June 4, 2025.