Acurx Pharmaceuticals (ACXP) investor relations material

Executive summary

• Advanced ibezapolstat clinical program with FDA and EMA engagement, aiming for a single pivotal phase III trial (IBZ-ASPIRE) for acute and recurrent CDI, and initiated the PATHFINDER study for recurrent CDI with enrollment expected in Q4 2026.

• Presented new preclinical and clinical data highlighting ibezapolstat's efficacy and microbiome-sparing effects, and expanded scientific partnerships.

• Secured FDA conditional acceptance and USPTO trademark allowance for the proprietary name Syfbezi for ibezapolstat, and expanded the patent estate with new patents in the US, Japan, and Mexico.

• No revenue generated to date; operations funded primarily through equity offerings and financings.

• Closed registered direct offerings and private placements in April 2026 to support clinical trials.

Financial highlights

• Ended Q2 2026 with $10.7 million in cash, up from $7.6 million at year-end 2025; working capital stood at $8.2 million.

• Raised $2.5 million via registered direct offering and $0.8 million under equity line of credit during the quarter.

• Q2 2026 R&D expenses were $1.1 million, up 104% year-over-year, mainly due to manufacturing and consulting costs for new trials.

• Q2 2026 net loss was $2.3 million ($0.53/share), compared to $2.2 million ($1.89/share) in Q2 2025; six-month net loss was $3.9 million ($1.13/share), improved from $4.4 million ($4.01/share) year-over-year.

• General and administrative expenses decreased to $1.2 million in Q2 2026 from $1.7 million in Q2 2025.

Outlook and guidance

• PATHFINDER trial is fully funded and expected to provide key data for FDA evaluation; ongoing efforts to secure funding for the international ASPIRE phase III trial.

• Received FDA and EMA agreement on Phase 3 trial design, providing a clear regulatory path for US and EU submissions.

• Current cash resources are not sufficient to meet anticipated requirements for at least 12 months; additional financing will be needed.

• Sufficient API and formulated product available to support both PATHFINDER and ASPIRE trials.

• Management expects continued net losses and negative cash flows for the foreseeable future.