Acurx Pharmaceuticals, Inc.

Overview

• Headquarters: 259 Liberty Avenue, Staten Island, NY 10305
• Website: www.acurxpharma.com
• Company type: Late-stage biopharmaceutical company developing Gram-positive selective antibiotics (GPSS)
• Core mechanism: Small-molecule inhibitors of Gram-positive DNA polymerase IIIC (pol IIIC), which block DNA replication and cause cell death in targeted Gram-positive bacteria

Business focus

• Therapeutic approach:
  • Develop GPSS antibiotics that inhibit bacterial DNA polymerase IIIC (pol IIIC)
  • Aim to treat Gram-positive infections while minimizing disruption to the gut microbiome
• Target pathogens and indications:
  • Clostridioides difficile (CDI)
  • Methicillin-resistant Staphylococcus aureus (MRSA)
  • Vancomycin-resistant Enterococcus (VRE)
  • Drug-resistant Streptococcus pneumoniae (DRSP)
  • Bacillus anthracis (anthrax; Bioterrorism Category A threat-pathogen)

Pipeline and clinical development

• Lead candidate: ibezapolstat (formerly ACX-362E) — oral pol IIIC inhibitor for CDI
• ACX-375C: additional pol IIIC inhibitors in preclinical development targeting MRSA, VRE, PRSP, and systemic indications
• Ibezapolstat clinical status:
  • Phase 2 program completed (Phase 2a and 2b for CDI); Phase 3 planning under consideration
  • Regulatory designations: FDA Fast Track and QIDP; IND active; EMA engagement for Phase 3 pathway in the EU; SME designation from EMA (Feb 2024)
  • Phase 2 results:
    • Phase 2a: Complete eradication of colonic C. difficile by day 3; 100% clinical cure at end of treatment in the Phase 2a cohort (10/10)
    • Phase 2b: 96% pooled clinical cure rate across Phase 2 segments (25/26); ibezapolstat 15/16 vs. vancomycin 14/14 in the control arm
    • Phase 2b dosing: ibezapolstat 450 mg every 12 hours vs. vancomycin 125 mg every 6 hours for 10 days
    • A Phase 2b segment was discontinued early due to positive outcomes

Intellectual property

• U.S. patent 8,796,292 covering ibezapolstat and related disubstituted purines; current expiration September 2030 (subject to extensions)
• Related composition-of-matter patent protection in Europe, Japan, and Canada with similar expiration timing (subject to extensions)
• Additional ACX-375C patents filed (Australia, Japan, U.S. and international)
• Regulatory exclusivity considerations include QIDP-driven exclusivity in the U.S. and other international exclusivities

Manufacturing and supply

• Clinical supply (Phase 1/Phase 2) sourced from Piramal Pharma Solutions (India); drug product packaged as 150 mg capsules
• Projected commercial batch size: 10–15 kg
• Projected cost of goods sold (COGS): less than 5% of anticipated sales price
• Stability: drug substance stable for ~48 months; drug product expected to have at least a 24-month shelf life

Financials and operating metrics

• Revenue: $0
• Net loss:
  • Year ended December 31, 2025: $8.0 million
  • Year ended December 31, 2024: $14.1 million
• Cash and cash equivalents: approximately $7.6 million as of December 31, 2025
• Employees: 4 full-time (as of March 12, 2026)
• Capital activities and liquidity events:
  • IPO completed June 2021; net proceeds approximately $14.8 million
  • July 2022: registered direct offering and private placement; net proceeds approximately $3.7 million
  • May 2023: registered direct offering and private placement; net proceeds approximately $3.5 million
  • November 2023: At-the-Market (ATM) offering established for up to $17.0 million; by year-end 2025 ATM activity produced gross proceeds of $9.2 million and net proceeds of $8.8 million
  • January 2025: registered direct offering and private placement; net proceeds $2.1 million
  • March 2025: registered direct offering and private placement; net proceeds $0.9 million
  • May 8, 2025: entered equity line of credit (ELOC) with Lincoln Park for up to $12.0 million; net proceeds approximately $3.8 million as of December 31, 2025
  • June 17, 2025: warrant inducement agreement; net proceeds approximately $2.5 million
• Liquidity note: The company reported that existing resources were not expected to be sufficient to fund operations for at least 12 months from December 31, 2025; the financial statements acknowledge substantial doubt about going concern

Market and strategy

• CDI market: significant healthcare-associated infection with high recurrence rates
• Projected peak U.S. CDI market opportunity in excess of $1 billion annually; preliminary full-course pricing estimate of $3,000 to $3,500
• Competitive landscape: current CDI therapies include vancomycin and fidaxomicin; other approaches include antibodies and microbiome therapies
• Differentiation: emphasis on preserving the gut microbiome and reducing recurrence
• Commercial strategy: evaluate partnering with a fully integrated pharmaceutical company for late-stage trials and commercialization, or conduct Phase 3 development prior to a partnership; ongoing evaluation of strategic transactions and licensing opportunities

Key activities and status

• Core business: development of pol IIIC inhibitors as a new class of antibiotics for Gram-positive infections, led by ibezapolstat for CDI
• Development stage: Phase 2 completed for CDI; Phase 3 planning under consideration; ACX-375C in preclinical/lead optimization
• Intellectual property: multiple patents with protection through 2030 (U.S. and international) and additional filings for ACX-375C
• Financial posture: pre-revenue, operating losses, limited cash, and ongoing capital-raising activity