Acurx Pharmaceuticals (ACXP) investor relations material

Executive summary

• Launched a new clinical trial program for ibezapolstat targeting recurrent C. difficile infection (rCDI), aiming to shift treatment paradigms and demonstrate efficacy in both treatment and prevention.

• Presented positive phase II results for ibezapolstat, showing 96% clinical cure and no recurrence, with additional microbiome-sparing data.

• Announced a new U.S. patent for Pol IIIC inhibitors, extending protection to December 2039.

• Highlighted ongoing funding initiatives, government engagement, and scientific advances, including publications and presentations at IDWeek and Nature Communications.

Financial highlights

• Ended Q4 2025 with $7.6 million in cash, up from $3.7 million at the end of 2024.

• Raised $1.5 million in Q4 and $4 million for the full year through the equity line of credit.

• Research and development expenses decreased to $0.3 million in Q4 2025 from $0.8 million in Q4 2024; full-year R&D expenses dropped to $1.8 million from $5.4 million.

• General and administrative expenses fell to $1.3 million in Q4 2025 from $2 million in Q4 2024; full-year G&A expenses were $6.3 million, down from $8.7 million.

• Reported a net loss of $1.6 million ($0.73/share) in Q4 2025, compared to $2.8 million ($3.29/share) in Q4 2024; full-year net loss was $8 million ($5.32/share), down from $14.1 million ($17.45/share) in 2024.

Outlook and guidance

• Preparing to advance ibezapolstat to international Phase 3 clinical trials for C. difficile infection, with positive regulatory feedback from FDA and EMA.

• The new rCDI clinical trial will start enrolling in the second half of 2026, with full enrollment expected in 12-15 months.

• Phase III trial size for rCDI projected at 360-400 patients, pending pilot data.

• Potential for a single pivotal trial for broader CDI approval, pending FDA guidance on one-trial registration.

• Plans to seek FDA approval for rCDI treatment and prevention under the Limited Population Pathway, pending successful Phase 3 results.