Annual report [Section 13 and 15(d), not S-K Item 405]

SUBSEQUENT EVENTS

v3.25.4
SUBSEQUENT EVENTS
12 Months Ended
Dec. 31, 2025
SUBSEQUENT EVENTS  
SUBSEQUENT EVENTS

NOTE 10 – SUBSEQUENT EVENTS

Under the ELOC, the Company sold an additional 482,038 shares of its common stock for approximately $1.0 million subsequent to year end, bringing the cumulative total to 1,233,434 shares of common stock, with gross proceeds of approximately $4.9 million through March 12, 2026.

On March 9, 2026, the Company announced a new clinical development initiative to expand the ibezapolstat program into recurrent C. difficile infection (rCDI). The initiative includes an open label pilot trial in multiply recurrent CDI that will enroll up to 20 patients who have experienced at least two recurrences within the past 12 months. Trial start up activities are scheduled to begin later this month, and first patient enrollment is expected in the fourth quarter of this year. The Company intends to use data from this 20 patient study to inform the design of a planned active controlled Phase 3 registration trial in rCDI. Following a successful pivotal Phase 3 study, the Company plans to seek the United States Food and Drug Administration’s approval under the Limited Population Pathway for Antibacterial and Antifungal Drugs (LPAD) for treatment and prevention of rCDI.