New Risk • May 13
New major risk - Revenue and earnings growth Earnings are forecast to decline by an average of 0.5% per year for the foreseeable future. This is considered a major risk. Ultimately, shareholders want to see a good return on their investment and that generally comes from sharing in the company's profits. If profits are expected to decline, then in most cases the share price will decline over time as well. In addition, if the company pays dividends it will also likely need to reduce or cut them, striking a dual blow to total shareholder returns. Currently, the following risks have been identified for the company: Major Risks Share price has been highly volatile over the past 3 months (42% average weekly change). Earnings are forecast to decline by an average of 0.5% per year for the foreseeable future. Shareholders have been substantially diluted in the past year (213% increase in shares outstanding). Revenue is less than US$1m. Market cap is less than US$10m (US$7.53m market cap). Minor Risk Currently unprofitable and not forecast to become profitable over next 3 years (US$29m net loss in 3 years). New Risk • May 12
New major risk - Revenue and earnings growth Earnings are forecast to decline by an average of 0.4% per year for the foreseeable future. This is considered a major risk. Ultimately, shareholders want to see a good return on their investment and that generally comes from sharing in the company's profits. If profits are expected to decline, then in most cases the share price will decline over time as well. In addition, if the company pays dividends it will also likely need to reduce or cut them, striking a dual blow to total shareholder returns. Currently, the following risks have been identified for the company: Major Risks Share price has been highly volatile over the past 3 months (42% average weekly change). Earnings are forecast to decline by an average of 0.4% per year for the foreseeable future. Shareholders have been substantially diluted in the past year (213% increase in shares outstanding). Revenue is less than US$1m. Market cap is less than US$10m (US$8.00m market cap). Minor Risk Currently unprofitable and not forecast to become profitable over next 3 years (US$28m net loss in 3 years). Announcement • May 05
Acurx Pharmaceuticals, Inc. Presents Scientific Poster on DNA Pol IIIC Inhibitors' Microbiome Evaluation at ESCMID Global Acurx Pharmaceuticals, Inc. announced presentation of a scientific poster at the 35th Congress of ESCMID Global (European Society of Clinical Microbiology and Infectious Diseases) held in Munich, Germany from April 17-21, 2026. Neutropenic CD-1 mice were infected intramuscularly with methicillin-resistant Staphylococcus aureus (MRSA) and subsequently treated with one of three Acurx DNA pol IIIC inhibitors, linezolid, or placebo administered orally. Acurx compounds achieved potentially therapeutic plasma levels and reduced MRSA tissue burden. Acurx antibiotics maintained a substantially higher gut microbial diversity and a community structure similar to baseline and distinct from linezolid. Unlike linezolid, ACX compounds maintain Bacteroidota-dominant community structure and prevent Proteobacteria expansion in the gastrointestinal tract. DNA pol IIIC inhibitors demonstrate a class effect of potentially clinically-relevant gut microbiome preservation while demonstrating systemic antibacterial activity. Acurx's DNA pol IIIC inhibitor preclinical product candidates are FDA QIDP and Fast-Track eligible and target Gram-positive infections classified as Serious Threat priorities by CDC. Using microbiome profiling shotgun metagenomics (MetaPhlAn) the authors concluded that DNA pol IIIC compounds represent a targeted strategy to treat resistant Gram-positive infections while preserving microbiome structure, minimizing downstream complications associated with antibiotic-induced dysbiosis. Acurx's portfolio of preclinical compounds include clinical applications for infections caused by MRSA such as: ABSSI, Hospital Acquired and Ventilator Acquired Bacterial Pneumonia, bacteremia with or without sepsis and/or endocarditis, bone and joint and diabetic foot infections. The poster is available on the Acurx Pharmaceuticals website. Acurx previously announced that it will conduct a new clinical trial in patients with recurrent C. difficile Infection (rCDI) while its program in the broader CDI patient population is ready to advance to Phase 3 international clinical trials, subject to receiving appropriate funding. This new clinical trial in rCDI begins with an open-label pilot trial to gain experience with IBZ in patients with multiply-recurrent CDI with at least 3 episodes of CDI within the past 12 months. This will inform elements of a planned active-controlled, Phase 3 registration trial in the rCDI indication to be implemented following favorable results from the open-label 20 patient trial. Upon subsequent successful completion of the Ph3 pivotal rCDI trial, and per the operative FDA procedure, Acurx plans to request FDA approval for treatment and prevention of rCDI under the FDA's Limited Population Pathway for Antibacterial and Antifungal Drugs (Guidance for Industry, 2020). Acurx had also previously announced that it had received positive regulatory guidance from the EMA during its Scientific Advice Procedure which confirmed that the clinical, non-clinical and CMC (Chemistry Manufacturing and Controls) information package submitted to EMA supports advancement of the ibezapolstat Phase 3 program and if the Phase 3 program is successful, supports the submission of a Marketing Authorization Application (MAA) for regulatory approval in Europe. The information package submitted to EMA by the Company to which agreement has been reached with EMA included details on Acurx's two planned international Phase 3 clinical trials, 1:1 randomized (designed as non-inferiority vs vancomycin), primary and secondary endpoints, sample size, statistical analysis plan and the overall registration safety database. With mutually consistent feedback from both EMA and FDA, Acurx is well positioned to commence our international Phase 3 registration program. The primary efficacy analysis will be performed using a Modified Intent-To-Treat (mITT) population. This will result in an estimated 450 subjects in the mITT population, randomized in a 1:1 ratio to either ibezapolstat or standard-of-care vancomycin, enrolled into the initial Phase 3 trial. The trial design not only allows determination of ibezapolstat's ability to achieve Clinical Cure of CDI as measured 2 days after 10 days of oral treatment but also includes assessment of ibezapolstat's potential effect on reduction of CDI recurrence in the target population. In the event non-inferiority of ibezapolstat to vancomycin is demonstrated, further analysis will be conducted to test for superiority. Ibezapolstat is the Company's lead antibiotic candidate planning to advance to international Phase 3 clinical trials to treat patients with C. difficile infection. Ibezapolstat is a novel, orally administered antibiotic, being developed as a Gram-Positive Selective Spectrum (GPSS®) antibacterial. It is the first of a new class of DNA polymerase IIIC inhibitors under development by Acurx to treat bacterial infections. Ibezapolstat's unique spectrum of activity, which includes C. difficile but spares other Firmicutes and the important Actinobacteria phyla, appears to contribute to the maintenance of a healthy gut microbiome. 
