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    ACXP
    Earnings call· Jun 2026(Q2 FY26)

    Acurx Pharmaceuticals Q2 FY26 earnings call ACXP

    Aug 14, 2026 Source

    Executive summary

    Acurx Pharmaceuticals Q2 FY26 — FDA Guidance for Phase III and Funding Secured

    Acurx Pharmaceuticals reported on its Q2 FY26 results, highlighting positive FDA guidance for its ibezapolstat development program, including the potential for a single pivotal Phase III study for acute CDI and recurrence prevention. The company also secured significant funding to support its PATHFINDER trial and operations for over a year, while advancing its pipeline with new partnerships and preclinical data. However, funding for the larger ASPIRE Phase III trial remains a key focus.

    Highlights

    5

    • FDA open to further discussion on NDA after single Phase III trial (IBZ-ASPIRE) and PATHFINDER study, especially if clinical efficacy is robust.

    • Received FDA conditional acceptance and USPTO Trademark Allowance for ibezapolstat's brand name, Syfbezi, in August 2026.

    • Secured funding of $7.1 million from a registered direct offering and $0.8 million from an Equity Line of Credit, ensuring operations for at least 1 year and funding the PATHFINDER trial.

    • New scientific partnership with Leiden University Medical Center in July 2026 to advance DNA pol III C inhibitors for novel antibiotics against Gram-positive pathogens.

    • Preclinical data showed ibezapolstat allows beneficial gut microorganisms to repopulate and is significantly more effective at killing C. diff than vancomycin and fidaxomicin in biofilm models.

    Concerns

    3

    • Phase III ASPIRE trial for acute CDI and recurrence reduction is pending appropriate funding from public, private, or partnership sources.

    • Net loss for Q2 FY26 was $2.3 million, compared to $2.2 million in Q2 FY25.

    • R&D expenses increased by $0.6 million to $1.1 million in Q2 FY26 due to manufacturing and consulting costs for the new recurrent CDI trial program.

    Guidance & targets

    1
    CategoryTargetConfidence
    PATHFINDER trial enrollment
    Anticipated to start in the fourth quarter
    medium materiality
    High

    Operational metrics

    25
    Cash and investments balance
    $10.7 millionvs. $7.6 million as of December 31, 2025
    As of June 30, 2026

    Company's cash position at the end of the quarter.

    Cash and investments balance
    $7.6 million
    As of December 31, 2025

    Company's cash position at the end of the prior fiscal year.

    Gross proceeds from Registered Direct Offering
    $2.5 million
    Q2 FY26

    Funds raised through a Registered Direct Offering during the quarter.

    Proceeds from Equity Line of Credit
    $0.8 million
    Q2 FY26

    Funds raised under the Equity Line of Credit during the quarter.

    Research and development expenses
    $1.1 millionup $0.6 million YoY
    Q2 FY26

    R&D expenses for the three months ended June 30, 2026.

    Research and development expenses
    $0.5 million
    Q2 FY25

    R&D expenses for the three months ended June 30, 2025.

    Research and development expenses
    $1.4 millionup $0.3 million YoY
    6M FY26

    R&D expenses for the six months ended June 30, 2026.

    Research and development expenses
    $1.1 million
    6M FY25

    R&D expenses for the six months ended June 30, 2025.

    General and administrative expenses
    $1.2 milliondown $0.5 million YoY
    Q2 FY26

    G&A expenses for the three months ended June 30, 2026.

    General and administrative expenses
    $1.7 million
    Q2 FY25

    G&A expenses for the three months ended June 30, 2025.

    General and administrative expenses
    $2.6 milliondown $0.7 million YoY
    6M FY26

    G&A expenses for the six months ended June 30, 2026.

    General and administrative expenses
    $3.3 million
    6M FY25

    G&A expenses for the six months ended June 30, 2025.

    Net loss
    $2.3 millionvs. $2.2 million Q2 FY25
    Q2 FY26

    Net loss for the three months ended June 30, 2026.

    Diluted EPS
    $0.53vs. $1.89 Q2 FY25
    Q2 FY26

    Diluted earnings per share for the three months ended June 30, 2026.

    Net loss
    $2.2 million
    Q2 FY25

    Net loss for the three months ended June 30, 2025.

    Diluted EPS
    $1.89
    Q2 FY25

    Diluted earnings per share for the three months ended June 30, 2025.

    Net loss
    $3.9 millionvs. $4.4 million 6M FY25
    6M FY26

    Net loss for the six months ended June 30, 2026.

    Diluted EPS
    $1.13vs. $4.01 6M FY25
    6M FY26

    Diluted earnings per share for the six months ended June 30, 2026.

    Net loss
    $4.4 million
    6M FY25

    Net loss for the six months ended June 30, 2025.

    Diluted EPS
    $4.01
    6M FY25

    Diluted earnings per share for the six months ended June 30, 2025.

    Shares outstanding
    4,683,253
    As of June 30, 2026

    Total common shares outstanding at the end of the quarter.

    Shares issued from Registered Direct Offering
    825,085
    April 2026

    Number of shares of common stock or prefunded warrants issued in the Registered Direct Offering.

    Registered Direct Offering purchase price
    $3.03
    April 2026

    Purchase price per share for the Registered Direct Offering.

    Short-term warrants issued
    1.65 million
    April 2026

    Number of unregistered short-term warrants issued in a concurrent private placement.

    Short-term warrant exercise price
    $2.78
    April 2026

    Exercise price for the unregistered short-term warrants.

    Industry KPIs

    3
    MetricValueDetails
    Pipeline read out calendarPATHFINDER study enrollment anticipated Q4 2026
    Regulatory approvals filingsFDA conditional acceptance and USPTO Trademark Allowance for Syfbezi
    Clinical trial efficacy safety dataIbezapolstat superior in biofilm models, significantly more effective at killing C. diff than vancomycin and fidaxomicin

    Deals & partnerships

    1
    Leiden University Medical CenterContinuation of scientific partnership to advance development of DNA pol III C inhibitors.

    This new partnership builds on previously reported successful results from an innovative research grant. It will enable further mechanistic research into DNA pol III C inhibition to accelerate the development of novel new antibiotics that are systemically active against a wide range of Gram-positive pathogens resistant to currently available antibiotics. It also aims to generate the first-ever 3D structure of pol C from methicillin-resistant Staphylococcus aureus in complex with an Acurx inhibitor.

    Risks & headwinds

    2
    Funding for Phase III ASPIRE trialOngoing

    Phase III clinical trial program with ASPIRE for acute CDI and recurrence reduction is pending appropriate funding from public or private sources or partnerships.

    Mitigation: Company is pursuing several initiatives to secure this funding and will report progress on future updates.

    Challenging industry sectorOngoing

    Not quantified

    Mitigation: Company remains confident in navigating challenging times while ibezapolstat's competitive profile continues to evolve and strengthen.

    What to watch in Q3 FY26

    3

    PATHFINDER trial enrollment

    Q4 FY26
    CurrentStart-up activities underway
    TargetEnrollment initiated

    Why it matters

    Successful enrollment is a key step for the recurrent CDI trial, which could provide significant supportive data for FDA evaluation and potentially open an LPAD pathway.

    As you may recall from our previous announcements, we've begun start-up activities to conduct the 20-patient groundbreaking PATHFINDER study in mostly recurrent CDI with enrollment anticipated to start in the fourth quarter.

    Q&A highlights

    5

    Does the company have enough API for PATHFINDER and ASPIRE trials, and what is the status of ibezapolstat manufacturing?

    The company has plenty of API and formulated product ready for the PATHFINDER trial. They are also poised to have enough API manufacturing with appropriate dating for the ASPIRE trial.

    “We stand on -- and we have plenty of API and also the formulated product is all ready to go to support the PATHFINDER trial, and we're poised to have enough API manufacturing with appropriate dating to start the ibezapolstat ASPIRE trial as well.”

    asked by Matthew Keller · answered by Robert DeLuccia

    2 min read6 chapters

    Detailed Narrative

    01

    FDA Meeting and Phase III Strategy

    Acurx met with the FDA in July 2026 to discuss its plan for a single Phase III study (IBZ-ASPIRE) in acute CDI. The FDA indicated openness to further discussion on the totality of evidence, including the PATHFINDER study, at a pre-NDA meeting, particularly if clinical efficacy results are robust. This suggests a potential pathway for approval for both CDI treatment and prevention of recurrence.

    02

    Ibezapolstat Brand Identity

    In August 2026, the company received FDA conditional acceptance and USPTO Trademark Allowance for its proprietary brand name for ibezapolstat, "Syfbezi," marking an initial step towards commercial identity and international registration. These milestones will form the basis for the commercial identity as the company prepares to advance towards its international Phase III registration program and ultimate commercialization.

    03

    Scientific Partnerships and Preclinical Research

    Acurx announced a continuation of its scientific partnership with Leiden University Medical Center in July to advance DNA pol III C inhibitors. This collaboration aims to develop novel, systemically active antibiotics against Gram-positive pathogens and generate the first-ever 3D structure of pol C from MRSA in complex with an Acurx inhibitor to advance discovery of new compounds.

    04

    Microbiome Sparing Effects and Biofilm Efficacy

    Scientific data presented in July by Dr. Kevin Garey's team from the University of Houston College of Pharmacy demonstrated that ibezapolstat allows beneficial gut microorganisms to repopulate the microbiome, preventing recurrence. In addition, ibezapolstat and fidaxomicin were superior in biofilm experimental models, with ibezapolstat significantly more effective at killing C. diff than vancomycin and fidaxomicin.

    05

    Funding and Financial Position

    The company closed a registered direct offering of up to $7.1 million in April, issuing 825,085 shares or prefunded warrants at $3.03 per share, and a concurrent private placement of unregistered short-term warrants to purchase up to 1.65 million shares at an exercise price of $2.78. This, combined with $0.8 million from an Equity Line of Credit, ensures funding for the PATHFINDER trial and operations for at least one year.

    06

    Patent Portfolio and Regulatory Designations

    Acurx has secured 6 U.S. patents and 10 international patents protecting ibezapolstat and the ACX-375C program. A new patent was issued in Q1 related to ibezapolstat's use in treating CDI, reducing recurrence, and improving gut microbiome health. Ibezapolstat holds FDA QIDP and Fast Track designations for CDI treatment, and SME status in the EU.

    AI-generated summary of the company’s earnings call. Not investment advice.