ACXP

• Clinical Development for Ibezapolstat (Cifbezi) for CDI • In July 2026, Accurix held a meeting with the FDA to discuss acceptability of a single Phase 3 pivotal trial (IBEZ-Aspire) for a New Drug Application (NDA) for acute CDI. The FDA stated it is open to reviewing the totality of evidence from the Ibezapolstat development program at a pre-NDA meeting after IBEZ-Aspire and the 20-patient open-label Pathfinder study (for multiple recurrent CDI) are completed, particularly if results are robust. Robust data from both trials can support approval for both treatment and prevention of recurrent CDI. • Startup activities for the Pathfinder study are complete, with enrollment expected to start in Q4 2026; the trial is already fully funded. Positive Pathfinder results will strengthen Ibezapolstat's product profile and provide supporting data for FDA evaluation. • The FDA granted conditional acceptance of the proprietary brand name Cifbezi for Ibezapolstat, and the USPTO issued a trademark allowance for the brand. • Ibezapolstat holds FDA QIDP and Fast Track designations for CDI, and the company has SME status in the EU.

• Preclinical and Early Pipeline Progress • Accurix extended its scientific partnership with Leiden University Medical Center to advance development of DNA Pol3C inhibitors, a novel class of antibiotics targeting multi-drug resistant gram-positive pathogens. The partnership will fund further mechanistic research and aims to generate the first ever 3D structure of Pol3C from methicillin-resistant Staph aureus (MRSA) bound to an Accurix inhibitor, to support new drug discovery. • Preclinical data published by University of Houston researchers showed Ibezapolstat preserves beneficial gut microbiome, allowing it to repopulate and prevent CDI recurrence. Ibezapolstat was also significantly more effective at killing C. diff in biofilm models than vancomycin or fidaxomicin. • Preclinical data on a systemic DNA Pol3C inhibitor was presented at the 35th ESC NID Congress in Munich, showing the compound achieved therapeutic plasma levels, reduced MRSA tissue burden, and preserved gut microbiome diversity (unlike conventional antibiotics), confirming microbiome-sparing effects as a class feature of DNA Pol3C inhibitors.

• Intellectual Property and Financing • Accurix currently holds 6 issued U.S. patents and 10 issued international patents covering Ibezapolstat and the ACX375C DNA Pol3C program, with additional national applications pending. A new U.S. patent covering Ibezapolstat's use for CDI treatment and recurrence reduction was issued in Q1 2026. • In April 2026, Accurix closed a $7.1 million registered direct offering, plus a concurrent private placement of short-term warrants to purchase up to 1.65 million additional common shares. Combined with remaining availability under the firm's equity line of credit, this funding supports the Pathfinder trial and operating expenses for at least 12 months. As of Q2 end 2026, the company held $10.7 million in cash, up from $7.6 million at December 31 2025.

• Financial Results • Q2 2026 net loss was $2.3 million (53 cents per diluted share), compared to a $2.2 million net loss ($1.89 per diluted share) in Q2 2025. Year-to-date 2026 net loss was $3.9 million ($1.13 per diluted share), compared to a $4.4 million net loss ($4.01 per diluted share) in the first half of 2025. As of June 30 2026, there were 4,683,253 common shares outstanding.

• The company maintains that it is prepared to initiate the pivotal Phase 3 IBEZ-Aspire trial pending securing sufficient funding via public/private sources or a partnership; efforts to secure this funding are ongoing.
• Enrollment for the fully funded Pathfinder 20-patient recurrent CDI trial is on track to begin in Q4 2026, with expected completion within 12 to 18 months of enrollment start.
• No changes to prior long-term operational or financial guidance were announced during the call.

Accurix Pharmaceuticals is a clinical-stage biotech company focused on novel antibiotic development, and has no commercial product segments generating revenue as of Q2 2026. The firm only reports operating expenses, which are split into two functional categories: 1) Research and Development (R&D): Q2 2026 R&D expenses were $1.1 million, up $0.6 million from $0.5 million in Q2 2025. Year-to-date (first half 2026) R&D expenses were $1.4 million, up $0.3 million from $1.1 million in the first half of 2025. The increase is driven by higher manufacturing costs ($0.3 million Q2, $0.2 million YTD) and higher consulting costs ($0.3 million Q2, $0.1 million YTD) associated with the new recurrent C. diff infection (CDI) trial program. 2) General and Administrative (G&A): Q2 2026 G&A expenses were $1.2 million, down $0.5 million from $1.7 million in Q2 2025. Year-to-date G&A expenses were $2.6 million, down $0.7 million from $3.3 million in the first half of 2025. The decrease is driven by lower professional fees ($0.3 million Q2/YTD), lower legal costs ($0.1 million Q2, $0.2 million YTD), and lower share-based compensation expense ($0.1 million Q2, $0.2 million YTD).

• Forward-looking statements regarding clinical trial progress, regulatory approval, and funding outcomes are subject to inherent uncertainties, and actual results may differ materially from expectations, per standard SEC disclosures.
• The FDA's acceptance of the single-trial development pathway for NDA approval is conditional on achieving robust efficacy and high-quality clinical data, with no guarantee that trial results will meet these requirements.
• The company depends on external funding (partnerships, public/private capital) to advance the large, pivotal IBEZ-Aspire trial; there is no guarantee that sufficient funding will be secured on acceptable terms, if at all.
• All antibiotic clinical development is subject to regulatory risk, as regulatory requirements for approval can change over the course of the program.

Q: Do you have enough active pharmaceutical ingredient (API) for planned upcoming trials, and what is your current status on manufacturing preparation?

A: The company confirmed it has sufficient API and formulated product ready to fully support the Pathfinder trial, and also enough API with appropriate shelf life to initiate the IBEZ-Aspire Phase 3 trial once funding is secured.

Q: The ASPIRE trial is planned as an international trial; what geographies are you considering, and have you started trial activities in these regions?

A: The trial will include sites in Western and Eastern Europe, prioritizing regions with high incidence of C. difficile infection. Site screening activities have not yet begun, as the trial remains pending funding activation.

Q: What criteria does the company consider "robust" data that would satisfy FDA requirements for approval, including efficacy benchmarks relative to vancomycin?

A: Robustness criteria fall into two categories: high-quality trial conduct (minimized protocol violations, low missing data, representative U.S.-aligned patient population) and consistent efficacy across endpoints, sites, and subgroups. IBEZ-Aspire is designed as a non-inferiority trial, not a superiority trial; the company only needs to show non-inferiority to vancomycin within a standard 10% confidence interval bound. The trial also includes an 8-week post-treatment follow-up period (longer than most prior CDI trials) to generate more robust recurrence data.

Q: How important is Pathfinder trial data for securing a partnership to fund the larger ASPIRE Phase 3 trial?

A: Positive Pathfinder data is considered very important for attracting partnership funding. Additionally, successful completion of Pathfinder opens a second approval pathway via the FDA's LPAD pathway for recurrent CDI, which allows NDA filing with only one smaller Phase 3 trial at roughly half the cost of the full ASPIRE program.