Acurx Pharmaceuticals, Inc. Q1 FY2026 earnings call

• Clinical Development Progress • Launched a new ibezapolstat clinical trial program for patients with recurrent Clostridioides difficile infection (rCDI), building on Phase II results that showed 100% clinical cure with no recurrence in 25 treated patients, with all 5 patients followed for 3 months remaining recurrence-free. • The program opens with a 20-patient open-label pilot study in multiply recurrent CDI patients (≥3 episodes in 12 months), which will inform the design of a planned Phase III active-controlled registration trial. Successful completion of the Phase III trial would support a regulatory submission for approval under the FDA's Limited Population Pathway for Antibacterial and Fungal Drugs (LPAD). • The ibezapolstat program for broader acute CDI is ready to advance to Phase III international pivotal trials. The company is pursuing the opportunity to seek approval with only one pivotal trial, enabled by new FDA guidance that formalizes a one-trial default standard for registration. • Preclinical development of novel systemic DNA polymerase IIIC inhibitor compounds for other resistant gram-positive infections demonstrated potentially therapeutic plasma levels, reduced MRSA tissue burden, and preserved gut microbiome diversity in preclinical studies, with results presented at the 2026 ESCMID Global Congress.

• Intellectual Property Updates • Secured a new patent from the Korean Patent Office covering DNA polymerase IIIC inhibitors (including ibezapolstat), expanding the company's global IP portfolio. To date, Acurx has 10 granted patents across the U.S., Israel, Japan, India, Australia, and Korea, with a recently granted U.S. patent for ibezapolstat's use in treating CDI, reducing recurrence, and protecting gut microbiome health that extends to December 2039. • Additional national patent applications remain under review globally.

• Financing • Completed a registered direct offering of common stock (and prefunded warrants) in April 2026, raising gross proceeds alongside concurrent issuance of short-term warrants for additional share purchases. Combined with remaining capacity under the company's equity line of credit, this funding is sufficient to complete the exploratory rCDI pilot trial. The company is pursuing additional funding opportunities to support the Phase III program for acute CDI.

Acurx Pharmaceuticals is a clinical-stage biotech company with no commercial product sales as of Q1 2026, so no product segment financial performance or revenue contribution is reported. All operating activity is focused on clinical development of ibezapolstat and preclinical pipeline candidates. The company's total operating expenses for Q1 2026 were $1.7 million, consisting of $0.3 million in research and development (R&D) expenses and $1.4 million in general and administrative (G&A) expenses.

Management did not provide traditional revenue or earnings guidance for the full year 2026, as the company remains in clinical development. Forward-looking updates include: • The open-label 20-patient rCDI pilot trial is currently in site start-up, with the first patient dosed expected around August 2026, with potential for acceleration. • Management expects that the new FDA one-trial registration guidance will not require changes to the already agreed-upon pivotal trial design for acute CDI, and is optimistic that the company can qualify to seek approval with a single Phase III trial for acute CDI, and potentially a single Phase III trial for rCDI under the LPAD pathway. • The company confirmed it has sufficient funding to complete the exploratory rCDI pilot trial, and is actively advancing initiatives to secure additional funding for the Phase III acute CDI program, with updates to be provided in future communications.

• Forward-looking statements regarding regulatory outcomes (including eligibility for single-trial approval) and clinical development timelines are subject to inherent uncertainties, and actual results may differ materially from current expectations based on FDA feedback, trial outcomes, and regulatory review. • The company requires additional external funding to complete Phase III development of ibezapolstat for acute CDI, and failure to secure sufficient funding on acceptable terms could delay or halt development programs. • Clinical trial success is not guaranteed: positive Phase II results do not ensure that Phase III trials will confirm efficacy or safety, which is required for regulatory approval. • The macroeconomic environment for biotech financing and drug development presents ongoing challenges that could impact the company's ability to advance its programs.

Q: What steps are needed to formalize eligibility for single-trial approval under the new FDA guidance, and does Acurx have the required confirmatory evidence to support this pathway? / A: The new single-trial guidance is a final FDA rule that already applies specifically to C. difficile infection, building on prior guidance dating to 2019. Acurx has a scheduled meeting with the FDA to discuss application of the guidance to its program, and does not expect it will require changes to its already agreed-upon pivotal trial design. The company meets the FDA's criteria for confirmatory evidence to support a single trial, including strong mechanistic data, in vitro activity and killing data, anti-virulence data, standard animal model efficacy data, detailed molecular mechanism of action understanding, and clinical Phase II microbiome data demonstrating reduced recurrence risk.

Q: What is the difference between Acurx's acute CDI and rCDI development pathways? / A: Acute CDI refers to an initial or single recurrent episode of infection requiring acute curative treatment, while the rCDI pathway targets patients with multiple recurrent episodes. Acurx has two separate approval pathways: one for acute CDI, which previously required two Phase III trials but may now move forward with one trial under the new guidance, and a separate pathway for rCDI under the LPAD designation, which starts with a 20-patient exploratory open-label trial, followed by a single Phase III trial if FDA agrees, creating two separate shots at approval.

Q: How does ibezapolstat's gut microbiome preservation fit into regulatory interactions and trial design, and what recurrence endpoints will the Phase III trial use? / A: While microbiome preservation is not expected to be a standalone approvable claim initially, it is a core pharmacologic feature of ibezapolstat that explains its low recurrence rate. Unlike standard antibiotics such as vancomycin, ibezapolstat preserves good gut bacteria that produce bile acids that suppress C. difficile growth, reducing recurrence risk. The trial will follow the standard 30-day (1-month) recurrence endpoint required by current regulation, but will also extend follow-up to 8 weeks (2 months) after treatment to align with labeling standards for approved recurrence prevention products, capturing longer-term recurrence data.

Q: How does Acurx's trial design align with the new FDA guidance's emphasis on diverse patient populations, including elderly patients? / A: The Phase III trial protocol has been expanded from the Phase II trial to include a broader patient population that covers all relevant subgroups, including elderly patients. The trial will also include geographic diversity across sites and racial/ethnic diversity, which meets the FDA's requirement for consistent efficacy across subgroups to support a single-trial approval.