Acurx Pharmaceuticals (ACXP) Q2 2024 earnings summary

Executive summary

• Completed successful End-of-Phase II FDA meeting, confirming Phase III readiness for ibezapolstat targeting C. difficile infection.

• Phase II trial of ibezapolstat showed a 96% clinical cure rate, with strong safety and microbiome preservation data.

• Advanced preparations for international Phase III trials and regulatory submissions in EU, UK, Japan, and Canada, including EMA SME designation.

• Presented Phase II data at major scientific conferences and received a new U.S. patent for ibezapolstat, expiring June 2042.

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

Financial highlights

• Ended Q2 2024 with $6.4 million in cash, down from $7.5 million at year-end 2023.

• Q2 2024 net loss was $4.1 million ($0.26/share), up from $3.4 million ($0.28/share) in Q2 2023.

• R&D expenses were $1.8 million in Q2 2024, up from $1.7 million in Q2 2023, mainly due to higher manufacturing costs.

• G&A expenses rose to $2.3 million in Q2 2024 from $1.7 million in Q2 2023, driven by increased professional fees and share-based compensation.

• Net cash used in operating activities was $5.9 million for the first half of 2024; net cash provided by financing activities was $4.8 million, mainly from the ATM program.

Outlook and guidance

• Anticipates FDA CMC review meeting in Q4 2024; Phase III trial start likely in Q1 2025 at the earliest.

• Plans to initiate two international Phase III trials, each enrolling 450 patients, randomized 1:1 to ibezapolstat or vancomycin.

• Current cash resources are not sufficient to fund operations for at least 12 months from June 30, 2024; additional financing will be required.

• Exploring non-dilutive funding options, including grants, royalty financing, territorial partnerships, and potential M&A.

• Sufficient cash runway into mid-2025 without ATM, or mid-2026 with full ATM utilization, assuming no trial initiation.