Acurx Pharmaceuticals (ACXP) Q3 2024 earnings summary

Executive summary

• Advanced ibezapolstat to Phase 3 readiness for C. difficile infection, with positive Phase 2 results showing a 96% clinical cure rate and no recurrence in patients followed for three months, presented at major scientific meetings.

• Achieved CMC readiness and positive FDA End-of-Phase 2 meeting, confirming Phase 3 readiness and planning for two international registration trials.

• Secured a new U.S. patent for ibezapolstat, expiring June 2042, covering treatment and recurrence reduction in C. difficile infection and improving gut health.

• Advanced preclinical programs targeting Gram-positive infections, including MRSA and anthrax, with ACX-375 analogues showing in vitro activity against resistant Anthrax and plans for a bioterrorism program.

• No revenue generated to date; company continues to operate at a net loss and relies on equity financing, with ongoing efforts to secure non-dilutive funding and strategic partnerships.

Financial highlights

• Ended Q3 2024 with $5.8 million in cash, down from $7.5 million at year-end 2023; working capital of $2.7 million.

• Raised $1.6 million in gross proceeds via ATM financing during Q3 2024; $6.4 million raised via ATM Program in first nine months of 2024, with $8.0 million capacity remaining.

• Q3 2024 net loss was $2.8 million ($0.17/share), improved from $3.1 million ($0.24/share) in Q3 2023; nine-month net loss increased to $11.3 million ($0.71/share) from $9.5 million ($0.77/share) year-over-year.

• Q3 2024 R&D expenses were $1.2 million, down from $1.3 million in Q3 2023; nine-month R&D expenses rose to $4.6 million from $4.1 million year-over-year.

• Q3 2024 G&A expenses were $1.6 million, down from $1.8 million in Q3 2023; nine-month G&A expenses increased to $6.7 million from $5.4 million year-over-year.

Outlook and guidance

• Plans to initiate two international Phase 3 registration trials for ibezapolstat, each with 450 patients, randomized against vancomycin.

• Anticipates FDA CMC meeting in Q4 2024 to enable Phase 3 trial initiation and plans to continue international regulatory filings, starting with the EMA.

• Flexibility to conduct Phase 3 trials sequentially due to regulatory exclusivity in the US (10 years) and Europe (9 years).

• Management expects continued net losses and negative cash flows for the foreseeable future; current cash is not sufficient to meet anticipated requirements for at least 12 months.

• Continued monitoring and development of a predictive diagnostic model for CDI recurrence.