ACXP

This article first appeared on GuruFocus. Cash Position: Ended Q2 2026 with $10.7 million in cash, up from $7.6 million as of December 31, 2025. Gross Proceeds Raised: Approximately $2.5 million from a Registered Direct Offering and $0.8 million under the Equity Line of Credit during the quarter. Research and Development Expenses (Q2): $1.1 million for the three months ended June 30, 2026, compared to $0.5 million in the same period of 2025. Research and Development Expenses (Six Months): $1.4 million for the six months ended June 30, 2026, compared to $1.1 million in the prior-year period. General and Administrative Expenses (Q2): $1.2 million for the three months ended June 30, 2026, down from $1.7 million in the same period of 2025. General and Administrative Expenses (Six Months): $2.6 million for the six months ended June 30, 2026, down from $3.3 million in the prior-year period. Net Loss (Q2): $2.3 million, or $0.53 per diluted share, for the three months ended June 30, 2026, compared to a net loss of $2.2 million, or $1.89 per diluted share, in the same period of 2025. Net Loss (Six Months): $3.9 million, or $1.13 per diluted share, for the six months ended June 30, 2026, compared to a net loss of $4.4 million, or $4.01 per diluted share, in the prior-year period. Shares Outstanding: 4,683,253 shares as of June 30, 2026. Warning! GuruFocus has detected 3 Warning Signs with PRE. Is ACXP fairly valued? Test your thesis with our free DCF calculator. Release Date: August 14, 2026 For the complete transcript of the earnings call, please refer to the full earnings call transcript. Acurx Pharmaceuticals Inc (NASDAQ:ACXP) received FDA guidance indicating openness to a single Phase 3 trial (IBZ-ASPIRE) for NDA filing, contingent on robust efficacy data and totality of evidence. The company secured FDA conditional acceptance and USPTO Trademark Allowance for the proprietary name 'Syfbezi' for ibezapolstat, advancing its commercial identity. Acurx Pharmaceuticals Inc (NASDAQ:ACXP) expanded its scientific partnership with Leiden University Medical Center to further develop DNA pol III C inhibitors, including research on MRSA. Preclinical data presented at ESCMID demonstrated that ibezapolstat and other DNA pol III C inhibitors preserve gut microbiome diversity while effectively targeting Gram-positive pathogens, a key differentiator. The company has sufficient API and formulated product ready to support both the PATHFINDER and ASPIRE trials, with cash totaling $10.7 million, funding operations for at least one year. The PATHFINDER trial is fully funded and, if successful, could provide a second pathway to FDA approval under the LPAD pathway for recurrent C. diff, potentially reducing the cost and scope of a pivotal trial. Acurx Pharmaceuticals Inc (NASDAQ:ACXP) reported a net loss of $2.3 million for Q2 2026, with increased R&D expenses due to manufacturing and consulting costs for the new recurrent CDI trial program. The Phase 3 ASPIRE trial is not yet funded, and the company is still seeking funding from public or private sources or partnerships, creating uncertainty about the timeline. The FDA's acceptance of a single Phase 3 trial is conditional and not guaranteed, as it depends on the robustness of clinical efficacy results and the totality of evidence at a pre-NDA meeting. The company's cash position, while improved, remains limited at $10.7 million, and the need for additional funding for the ASPIRE trial could lead to further dilution or delays. The international Phase 3 trial has not yet begun site screening, and the company has not provided specific details on the countries involved, indicating early-stage planning. The PATHFINDER trial enrollment is not expected to start until Q4 2026, and the ASPIRE trial timeline remains uncertain, potentially delaying potential commercialization. Q: What is the significance of the recent FDA meeting regarding the Phase 3 trial for ibezapolstat, and what did the FDA indicate about the potential for approval?A: David Luci (President and CEO) explained that the FDA is open to discussing the totality of evidence from the ibezapolstat clinical development program at a pre-NDA meeting after the completion of a single Phase 3 trial (IBZ-ASPIRE) and other trials, including the PATHFINDER study. The FDA acknowledged PATHFINDER as significant, and robust results from both trials could form the basis for potential approval for treating CDI and preventing recurrence. Q: Can you elaborate on the criteria for what constitutes "robust" data that would satisfy the FDA for approval, particularly regarding the reduction of recurrence?A: Michael Silverman (Medical Director) outlined two general categories: first, high-quality clinical trial practices, such as minimizing protocol violations and missing data; second, consistency of efficacy data across all endpoints, trial sites, and countries. Robert DeLuccia (Executive Chairman) added that the ASPIRE trial design measures patients eight weeks after treatment ends, and seeing no reinfection in a patient population with three or more prior episodes would be persuasive to the FDA. Q: What is the target for the ASPIRE trial in terms of efficacy compared to vancomycin, and is it a superiority or noninferiority trial?A: Michael Silverman (Medical Director) clarified that ASPIRE is a noninferiority trial, not a superiority trial. For the acute treatment endpoint, the trial needs to show noninferiority to vancomycin within standard bounds, with the lower limit of the confidence interval within 10%. Q: How important is the PATHFINDER trial data for securing a partnership to fund the Phase 3 ASPIRE trial, and is there an alternative pathway to approval?A: David Luci (President and CEO) stated that PATHFINDER data is quite important. He highlighted an alternative pathway: if the 20-patient open-label PATHFINDER trial is successful, the company could qualify for the LPAD pathway for recurrent C. diff, potentially allowing approval with just one Phase 3 trial at roughly half the cost of an ASPIRE trial. Q: Do you have enough API and formulated product for the upcoming trials, and what is the manufacturing status?A: Robert DeLuccia (Executive Chairman) confirmed that the company has plenty of API and formulated product ready to support the PATHFINDER trial. They are also poised with enough API manufacturing and appropriate dating to start the ibezapolstat ASPIRE trial when needed. Q: What geographies are being considered for the international ASPIRE trial, and have activities begun in those regions?A: Michael Silverman (Medical Director) indicated plans include Western and Eastern Europe. Robert DeLuccia (Executive Chairman) added that while they haven't begun screening yet, the trial will include countries with generally high incidence of C. difficile infection. Q: What is the company's cash position and financial runway following the recent funding activities?A: Robert Shawah (CFO) reported the company ended Q2 2026 with $10.7 million in cash, up from $7.6 million at the end of 2025. This includes proceeds from a Registered Direct Offering and the Equity Line of Credit. David Luci added that this funding ensures the company can conduct the PATHFINDER trial and fund operations for at least one year. Q: What were the key drivers of the changes in R&D and G&A expenses for the second quarter of 2026?A: Robert Shawah (CFO) explained that R&D expenses increased to $1.1 million from $0.5 million, driven by higher manufacturing and consulting costs associated with the new recurrent CDI trial program. G&A expenses decreased to $1.2 million from $1.7 million, primarily due to lower professional fees, legal costs, and share-based compensation. Q: What is the significance of the new scientific partnership with Leiden University Medical Center?A: David Luci (President and CEO) stated that the partnership will advance mechanistic research into DNA pol III C inhibition, aiming to develop new systemically active antibiotics against Gram-positive pathogens. The research also aims to generate the first-ever 3D structure of pol C from MRSA in complex with an Acurx inhibitor, which could accelerate discovery of new compounds for this high-priority pathogen. Q: What recent data was presented regarding the microbiome-sparing effects of the company's DNA pol III C inhibitors?A: David Luci (President and CEO) highlighted a poster presented at ESCMID showing that the novel pol III C inhibitors achieve therapeutic plasma levels and reduce MRSA tissue burden while maintaining higher gut microbial diversity, distinct from linezolid. Dr. Garey from the University of Houston noted that this targeted approach preserves the microbiome, which is considered the "clinical holy grail" of antibiotic development. For the complete transcript of the earnings call, please refer to the full earnings call transcript.

STATEN ISLAND, N.Y., Aug. 14, 2026 /PRNewswire/ -- Acurx Pharmaceuticals, Inc. (NASDAQ: ACXP) ("Acurx" or the "Company"), a late-stage biopharmaceutical company developing a new class of antibiotics for difficult-to-treat bacterial infections, announced today certain financial and operational results for the second quarter ended June 30, 2026. Highlights of the second quarter ended June 30, 2026, or in some cases shortly thereafter, include: In April 2026, the Company announced the closing of a registered direct offering of 825,085 shares of its common stock (or pre-funded warrants in lieu thereof) at a purchase price of $3.03 per share (or pre-funded warrant in lieu thereof) priced at-the-market under Nasdaq rules. In addition, in a concurrent private placement, the Company issued unregistered short-term warrants to purchase up to 1,650,170 shares of common stock. The short-term warrants have an exercise price of $2.78 per share, and are immediately exercisable upon issuance and will expire twenty-four months following the effective date of the registration statement registering the resale of the shares of common stock underlying the short-term warrants. This additional funding when coupled with the remaining availability under our Equity Line of Credit ensures that the Company has the financial resource to conduct the exploratory clinical trial in recurrent C. difficile infection. In April 2026, a scientific poster was presented at the 35th Congress of ESCMID Global (European Society of Clinical Microbiology and Infectious Diseases) held in Munich, Germany from April 17-21, 2026 showing that Acurx's orally absorbed DNA pol IIIC inhibitors in preclinical development have the unexpected benefit of gut microbiome preservation while demonstrating systemic antibacterial activity. Dr. Khurshida Begum, Research Scientist, University of Houston College of Pharmacy presented the poster demonstrating potentially therapeutic plasma levels, reduction of MRSA tissue burden and maintaining a substantially higher gut microbial diversity and community structure similar to baseline and distinct from linezolid. In July 2026, the Company's research and development team met with the FDA for the purpose of seeking their guidance on our plan to conduct a single phase 3 study and its acceptability as a pivotal trial for filing a New Drug Application (or NDA), the favorable outcome of which we provided in detail in our press release dated August 3, 2026. In July 2026, presentation of scientific data was provided at the 18th Biennial Congress of the Anaerobe Society of the Americas held at Columbia University Irving Medical Center in New York City by Dr. Kevin Garey and his team from the University of Houston. Data showed that following treatment with ibezapolstat (IBZ), the beneficial microorganisms in the gut will have the opportunity to repopulate the microbiome in a beneficial way that prevents recurrence. In addition, IBZ and fidaxomicin were superior in biofilm experimental models with IBZ significantly more effective at killing C. difficile than vancomycin and fidaxomicin. In July 2026, we signed a continuation of our scientific partnership with Leiden University Medical Center to advance development of Acurx's DNA polymerase IIIC (pol IIIC) Inhibitors. This new partnership builds on the previously reported successful results from the innovative research grant received in November 2025 from Health-Holland to Leiden University and Acurx. This new partnership will enable extending mechanistic research into DNA pol IIIC inhibition to accelerate the development of novel new agents that are systemically active against a range of Gram-positive pathogens resistant to currently available antibiotics. This new research also aims to generate the first-ever 3D structure of Pol C from methicillin-resistant Staphylococcus aureus (MRSA) in complex with an Acurx inhibitor to advance discovery of new compounds to treat this high-priority clinical pathogen. In August 2026, the Company received FDA Conditional Acceptance and USPTO Trademark Allowance of its proprietary name for ibezapolstat for the treatment and reduction of recurrence of C. difficile infection. In August 2026, we announced that the Japan and Mexico Patent Offices granted new patents, respectively, which cover DNA pol IIIC inhibitors including compositions of matter, methods of use, and pharmaceutical compositions, which further strengthen Acurx's intellectual property portfolio and represents the most recent addition to our expanding series of granted patents in the U.S. and internationally. To date, Acurx has secured six U.S. patents and an additional ten patents internationally, including Australia, Canada, Europe, Israel, India, Japan, Korea, and Mexico, all of which protect key aspects of the Company's ibezapolstat and the ACX‑375C program targeting DNA Polymerase IIIC. Additional country‑level patent applications remain under review. Second Quarter 2026 Financial Results Cash Position: The Company ended the quarter with cash totaling $10.7 million, compared to $7.6 million as of December 31, 2025. During the quarter, the Company raised a total of approximately $2.5 million of gross proceeds through a Registered Direct Offering, as well as $0.8 million under the Equity Line of Credit. R&D Expenses: Research and development expenses for the three months ended June 30, 2026 were $1.1 million compared to $0.5 million for the three months ended June 30, 2025, an increase of $0.6 million. The increase was due primarily to an increase in manufacturing costs of $0.3 million, and an increase in consulting costs of $0.3 million as a result of costs associated with the new recurrent CDI trial program. For the six months ended June 30, 2026, research & development expenses were $1.4 million compared to $1.1 million for the six months ended June 30, 2025. The $0.3 million increase was due primarily to a $0.1 million increase in consulting fees and a $0.2 million increase in manufacturing costs as a result of costs associated with the new recurrent CDI trial program. G&A Expenses: General and administrative expenses for the three months ended June 30, 2026 were $1.2 million compared to $1.7 million for the three months ended June 30, 2025, a decrease of $0.5 million. The decrease was primarily due to a $0.3 million decrease in professional fees, a $0.1 million decrease in legal costs, and a $0.1 million decrease in share-based compensation expense. For the six months ended June 30, 2026, general and administrative expenses were $2.6 million compared to $3.3 million for the six months ended June 30, 2025, a decrease of $0.7 million. The decrease was due primarily to a $0.3 million decrease in professional fees, $0.2 million decrease in legal costs, and $0.2 million decrease in share-based compensation expense. Net Income/Loss: The Company reported a net loss of $2.3 million or $0.53 per diluted share for the three months ended June 30, 2026 compared to a net loss of $2.2 million or $1.89 per diluted share for the three months ended June 30, 2025. For the six months ended June 30, 2026, the Company reported a net loss of $3.9 million or $1.13 per diluted share, compared to $4.4 million or $4.01 per diluted share for the six months ended June 30, 2025, all for the reasons previously mentioned. Conference Call As previously announced, David P. Luci, President and Chief Executive Officer, and Robert G. Shawah, Chief Financial Officer, will host a conference call to discuss the results and provide a business update as follows: Date: Friday, August 14, 2026Time: 8:00 a.m. ETToll free (U.S.): 1-877-790-1503; Access ID: 13761686 International: Click here for participant international Toll-Free access numbers https://www.incommconferencing.com/international-dial-in About Ibezapolstat Ibezapolstat is the Company's lead antibiotic candidate preparing for advancement into international Phase 3 clinical trials to treat patients with acute C. difficile Infection (CDI) and it is also preparing for a ground-breaking clinical trial targeting the prevention of recurrent CDI (rCDI). If successful, ibezapolstat will change the treatment paradigm for CDI and rCDI by providing one therapy for the full spectrum of CDI and rCDI from first occurrence to multiply recurrent episodes. 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. As previously announced, the Company has received final EMA and FDA agreement for our ibezapolstat pivotal Phase 3 trials in CDI. Their advice included and confirmed the non-inferiority study design elements, the patient population, primary and secondary endpoints, and size of the registration safety database. Acurx also now has a clear international roadmap for conduct of its Phase 3 program in CDI and, if successful, requirements for US NDA submission and EU Marketing Authorization. In June 2018, ibezapolstat was designated by the U.S. Food and Drug Administration (FDA) as a Qualified Infectious Disease Product (QIDP) for the treatment of patients with CDI and will be eligible to benefit from the incentives for the development of new antibiotics established under the Generating New Antibiotic Incentives Now (GAIN) Act. In January 2019, FDA granted "Fast Track" designation to ibezapolstat for the treatment of patients with CDI. The CDC has designated C. difficile as an urgent threat highlighting the need for new antibiotics to treat CDI. About Acurx Pharmaceuticals, Inc. Acurx Pharmaceuticals is a late-stage biopharmaceutical company focused on developing a new class of small molecule antibiotics for difficult-to-treat bacterial infections. The Company's approach is to develop antibiotic candidates with a Gram-positive selective spectrum (GPSS®) that blocks the active site of the Gram+ specific bacterial enzyme DNA polymerase IIIC (pol IIIC), inhibiting DNA replication and leading to Gram-positive bacterial cell death. Its R&D pipeline includes antibiotic product candidates that target Gram-positive bacteria, including Clostridioides difficile, methicillin- resistant Staphylococcus aureus (MRSA), vancomycin resistant Enterococcus (VRE), drug- resistant Streptococcus pneumoniae (DRSP) and B. anthracis (anthrax; a Bioterrorism Category A Threat-Level pathogen). Acurx's lead product candidate, ibezapolstat, for the treatment of C. difficile Infection (CDI) is Phase 3 ready to advance to international clinical trials subject to obtaining appropriate financing. The Company recently announced the launch of a ground-breaking clinical trial with ibezapolstat in patients with multiply-recurrent CDI (rCDI) that has the potential to shift the paradigm of treatment and prevention of rCDI from two agents to one. 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. The Company's preclinical pipeline includes development of an oral product candidate for treatment of ABSSSI (Acute Bacterial Skin and Skin Structure Infections), upon which a development program for treatment of inhaled anthrax is being planned in parallel. To learn more about Acurx Pharmaceuticals and its product pipeline, please visit www.acurxpharma.com. Forward-Looking Statements Any statements in this press release about our future expectations, plans and prospects, including statements regarding our strategy, future operations, prospects, plans and objectives, and other statements containing the words "believes," "anticipates," "plans," "expects," and similar expressions, constitute forward-looking statements within the meaning of The Private Securities Litigation Reform Act of 1995. Actual results may differ materially from those indicated by such forward-looking statements as a result of various important factors, including: whether ibezapolstat will benefit from the QIDP designation; whether ibezapolstat will advance through the clinical trial process on a timely basis; whether the results of the clinical trials of ibezapolstat will warrant the submission of applications for marketing approval, and if so, whether ibezapolstat will receive approval from the FDA or equivalent foreign regulatory agencies where approval is sought; whether, if ibezapolstat obtains approval, it will be successfully distributed and marketed; and other risks and uncertainties described in the Company's annual report filed with the Securities and Exchange Commission on Form 10-K for the year ended December 31, 2025, and in the Company's subsequent filings with the Securities and Exchange Commission. Such forward-looking statements speak only as of the date of this press release, and Acurx disclaims any intent or obligation to update these forward-looking statements to reflect events or circumstances after the date of such statements, except as may be required by law. Investor Contact: Acurx Pharmaceuticals, Inc.David P. LuciPresident & Chief Executive OfficerTel: 917-533-1469Email: [email protected] View original content:https://www.prnewswire.com/news-releases/acurx-pharmaceuticals-inc-reports-second-quarter-2026-results-and-provides-business-update-302850984.html

Our analysts just identified a stock with the potential to be the next Nvidia. Tell us how you invest and we'll show you why it's our #1 pick. Tap here. Management secured FDA guidance for a single Phase III trial (IBZ-ASPIRE) to serve as a pivotal study for NDA filing, contingent on robust clinical efficacy results. The company received conditional FDA acceptance and USPTO trademark allowance for 'Syfbezi' as the proprietary brand name for ibezapolstat, establishing its commercial identity. Strategic research partnerships with Leiden University and the University of Houston are focused on proving a 'class effect' for DNA pol III C inhibitors in preserving the gut microbiome. Performance attribution for the quarter reflects a strategic shift toward manufacturing and consulting costs specifically tied to the upcoming recurrent CDI trial program. Management emphasized that ibezapolstat has demonstrated superior killing effectiveness against C. diff compared to vancomycin and fidaxomicin in biofilm experimental models. The company is leveraging a dual-track development strategy, targeting both acute treatment and the prevention of recurrence to maximize the drug's clinical utility. Enrollment for the 20-patient PATHFINDER study in recurrent CDI is anticipated to commence in the fourth quarter of 2026. Current cash reserves of $10.7 million are projected to fund operations and the PATHFINDER trial for at least one year. The Phase III ASPIRE trial is planned as an international study, targeting geographies with high C. difficile incidence, including Western and Eastern Europe. Management is actively pursuing funding for the ASPIRE trial through public sources, private capital, or strategic partnerships. Future regulatory filings may utilize the LPAD pathway for recurrent CDI, potentially allowing for a more cost-effective approval route with a single Phase III trial. The commencement of the Phase III ASPIRE trial remains pending the acquisition of appropriate additional funding. Acurx completed a $7.1 million registered direct offering in April to strengthen the balance sheet for clinical execution. The company faces standard clinical development risks, with FDA approval for a single-trial NDA filing being 'open to further discussion' rather than guaranteed. Intellectual property protection was expanded with a new patent for treating CDI while simultaneously improving gut microbiome health. One stock. Nvidia-level potential. 30M+ investors trust Moby to find it first. Get the pick. Tap here. Management confirmed they have sufficient API and formulated product ready to support the PATHFINDER trial. The company is poised to manufacture enough API with appropriate dating to support the start of the ASPIRE trial as well. Robustness will be evaluated based on high-quality data, consistency of efficacy across all sites, and results that are representative of U.S. clinical practice. The ASPIRE trial will measure patients for 8 weeks post-treatment, an unusually long duration intended to provide persuasive evidence of reduced reinfection. The Phase III program is designed as a non-inferiority trial rather than a superiority trial. The goal is to show non-inferiority for acute treatment within standard statistical bounds, specifically a confidence interval within 10%. Management views the PATHFINDER results as critical for elevating the product profile and attracting partners to fund the larger ASPIRE trial. If successful, the PATHFINDER data could also enable the LPAD regulatory pathway, which would significantly reduce the cost of reaching the market.

STATEN ISLAND, N.Y., July 8, 2026 /PRNewswire/ -- Acurx Pharmaceuticals, Inc. (NASDAQ: ACXP) ("Acurx" or the "Company"), a late-stage biopharmaceutical company developing a new class of antibiotics for difficult-to-treat bacterial infections, announced today that the Company will discuss its second quarter 2026 financial results on Friday, August 14, 2026 at 8:00 am ET before the U.S. financial markets open. David P. Luci, President and Chief Executive Officer, and Robert G. Shawah, Chief Financial Officer, will host a conference call to discuss the results and provide a business update as follows: Click here for participant International Toll-Free access numbers About Ibezapolstat 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. In June 2018, ibezapolstat was designated by the U.S. Food and Drug Administration (FDA) as a Qualified Infectious Disease Product (QIDP) for the treatment of patients with CDI and will be eligible to benefit from the incentives for the development of new antibiotics established under the Generating New Antibiotic Incentives Now (GAIN) Act. In 2019, FDA granted "Fast Track" designation to ibezapolstat for the treatment of patients with CDI. The CDC has designated C. difficile as an urgent threat highlighting the need for new antibiotics to treat CDI. 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. As previously announced, the Company has received final EMA and FDA agreement for our ibezapolstat pivotal Phase 3 trials in CDI. Their advice included and confirmed the non-inferiority study design elements, the patient population, primary and secondary endpoints, and size of the registration safety database. Acurx also now has a clear international roadmap for conduct of its Phase 3 program in CDI and, if successful, requirements for US NDA submission and EU Marketing Authorization. Additionally, the Company has initiated start-up activities for a ground-breaking clinical trial in patients with multiply-recurrent CDI (rCDI) with the first patient expected to enroll in the fourth quarter this year. This trial begins with a 20-patient, open-label pilot trial in patients with multiply-recurrent CDI with at least 3 episodes of CDI and will inform elements of a planned active-controlled, Phase 3 registration trial in the rCDI. Upon subsequent successful completion of a 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). Successful trial outcome has the potential to shift the paradigm of treatment and prevention of rCDI from two agents to one. About Acurx Pharmaceuticals, Inc. Acurx Pharmaceuticals is a late-stage biopharmaceutical company focused on developing a new class of small molecule antibiotics for difficult-to-treat bacterial infections. The Company's approach is to develop antibiotic candidates with a Gram-positive selective spectrum (GPSS®) that blocks the active site of the Gram-positive specific bacterial enzyme DNA polymerase IIIC (pol IIIC), inhibiting DNA replication and leading to Gram-positive bacterial cell death. Its R&D pipeline includes antibiotic product candidates that target Gram-positive bacteria, including Clostridioides difficile, methicillin- resistant Staphylococcus aureus (MRSA), vancomycin resistant Enterococcus (VRE), drug- resistant Streptococcus pneumoniae (DRSP) and B. anthracis (anthrax; a Bioterrorism Category A Threat-Level pathogen). Acurx's lead product candidate, ibezapolstat, for the treatment of C. difficile Infection is Phase 3 ready with plans in progress to begin international clinical trials next year. The Company's preclinical pipeline includes development of an oral product candidate for treatment of ABSSSI (Acute Bacterial Skin and Skin Structure Infections), upon which a development program for post-exposure prophylaxis of inhalation anthrax is being planned in parallel. To learn more about Acurx Pharmaceuticals and its product pipeline, please visit www.acurxpharma.com. Forward-Looking Statements Any statements in this press release about our future expectations, plans and prospects, including statements regarding our strategy, future operations, prospects, plans and objectives, and other statements containing the words "believes," "anticipates," "plans," "expects," and similar expressions, constitute forward-looking statements within the meaning of The Private Securities Litigation Reform Act of 1995. Actual results may differ materially from those indicated by such forward-looking statements as a result of various important factors, including: whether ibezapolstat will benefit from the QIDP designation; whether ibezapolstat will advance through the clinical trial process on a timely basis; whether the results of the clinical trials of ibezapolstat will warrant the submission of applications for marketing approval, and if so, whether ibezapolstat will receive approval from the FDA or equivalent foreign regulatory agencies where approval is sought; whether, if ibezapolstat obtains approval, it will be successfully distributed and marketed; and other risks and uncertainties described in the Company's quarterly report on Form 10-Q filed with the Securities and Exchange Commission on for the quarter ended March 31, 2026, and in the Company's subsequent filings with the Securities and Exchange Commission. Such forward- looking statements speak only as of the date of this press release, and Acurx disclaims any intent or obligation to update these forward-looking statements to reflect events or circumstances after the date of such statements, except as may be required by law. Investor Contact:Acurx Pharmaceuticals, Inc.David P. Luci, President & CEOTel: 917-533-1469Email: [email protected] View original content:https://www.prnewswire.com/news-releases/acurx-pharmaceuticals-to-discuss-second-quarter-2026-financial-results-on-august-14-2026-conference-call-and-provide-business-update-302820298.html

Results are from Acurx's ongoing scientific collaboration with Leiden University Medical Center (LUMC) partially under a grant from Health Holland to further study the mechanism of action of DNA pol IIIC inhibitors LUMC highlighted Acurx's new class of promising antimicrobials, ibezapolstat and related analogues specifically target Gram-positive bacteria High-resolution cryo-electron microscopy resolved the structure of ibezapolstat in relationship to the binding pocket of a Gram-positive DNA pol IIIC to the level of 3.2Å The Company's preclinical pipeline includes development of an oral product candidate for treatment of ABSSSI (Acute Bacterial Skin and Skin Structure Infections), with a development program for post-exposure prophylaxis of inhalation anthrax being planned in parallel Ibezapolstat has previously been granted FDA QIDP and Fast-Track Designations and has received SME (Small and Medium-sized Enterprise) designation by the EMA STATEN ISLAND, N.Y., June 16, 2026 /PRNewswire/ -- Acurx Pharmaceuticals, Inc. (NASDAQ: ACXP) ("Acurx" or the "Company") is a late-stage biopharmaceutical company developing a new class of small molecule antibiotics for difficult-to-treat bacterial infections. Its lead antibiotic candidate, ibezapolstat (IBZ), is ready to advance to international pivotal Phase 3 clinical trials for treatment of patients with C. difficile infection (CDI). The Company today announced that a presentation was given by Mia Urem, PhD, from Leiden University Medical Center in the Netherlands entitled: "A unique inhibitor conformation selectively targets Gram+ Bacterial DNA Replication" at the Leiden Early Drug Discovery & Development (LED3) Scientific Conference on June 11, 2026. Attendees of this symposium were PhDs, post-doctoral researchers and faculty from Leiden University and the LUMC. The event focused on drug discovery and development with topics including antibiotics, antivirals, central nervous system and cancer. Additional focus included the use of AI and computer sciences, quantitative pharmacology, microbiology and medical biology. Dr. Urem's group utilized high-resolution cryo-electron microscopy to resolve the structure of ibezapolstat in relationship to the binding pocket of a Gram-positive DNA pol IIIC to the level of 3.2Å. The active site of the polymerase is conserved in >220 Gram-positive species, indicating potential for broad clinical utility of this bactericidal inhibitory mechanism of action of Acurx compounds. The distinctive non-planar conformation of IBZ and chemically related molecules, together with high conservation of the binding pocket in DNA pol IIIC, suggests that this is a general mechanism for this class of inhibitor and that a wide range of Gram-positive infections, including those caused by high-priority pathogenic Gram-positive bacteria, may be susceptible to treatment with Acurx pipeline antibiotics. According to Dr. Wiep Klaas Smits, Associate Professor/Principal Investigator, Leiden University Medical Center: "Our findings with regard to the structural biology of DNA pol IIIC in complex with inhibitors have important implications for the development of this novel class of antibiotics to treat high priority, multi-drug resistant, Gram-positive infections". Acurx's Executive Chairman, Bob DeLuccia, stated: "This research outcome provides a deeper understanding of the mechanism of action and selectivity of ibezapolstat with respect to the gut microbiota. These data will guide the rational design of new compounds with improved inhibitory activity and drug-like characteristics that will be crucial in addressing the pandemic of antimicrobial resistance". Acurx's R&D pipeline includes antibiotic product candidates that target Gram-positive bacteria, including Clostridioides difficile, methicillin- resistant Staphylococcus aureus (MRSA), vancomycin resistant Enterococcus (VRE), drug- resistant Streptococcus pneumoniae (DRSP) and B. anthracis (anthrax; a Bioterrorism Category A Threat-Level pathogen). The Company's preclinical pipeline includes development of an oral product candidate for treatment of ABSSSI (Acute Bacterial Skin and Skin Structure Infections), upon which a development program for treatment of inhaled anthrax is being planned in parallel. THE PRESENTATION IS POSTED ON THE ACURX WEBSITE www.acurxpharma.com About the Leiden Early Drug Discovery & Development (LED3) Multidisciplinary Research Network Leiden Early Drug Discovery & Development (LED3) is a multidisciplinary research network at Leiden University dedicated to advancing innovative approaches in early drug discovery and development. The initiative brings together 58 principal investigators from four institutes—the Institute of Biology Leiden (IBL), Leiden Academic Centre for Drug Research (LACDR), Leiden Institute of Advanced Computer Science (LIACS), and Leiden Institute of Chemistry (LIC), supported by the university's technology transfer office LURIS. Together, the network represents more than 250 researchers and staff with expertise spanning artificial intelligence, medicinal chemistry, molecular biology, pharmacology, metabolomics, structural biology, toxicology, and many other fields essential for modern drug discovery. About Leiden University Medical Center Leiden University was the first university to be established in the Netherlands. Its motto is praesidium libertatis – bastion of freedom. The University wishes to create an increasingly attractive and challenging working climate for top academics and young researchers that is guided by quality and excellence. Leiden University Medical Center (LUMC) research aims to meet the highest international standards of quality and academic integrity. LUMC promotes excellent research through greater collaboration, both disciplinary and interdisciplinary; stronger positioning and greater scope for top talent; and better supervision and more support for young researchers. Antimicrobial resistant microorganisms are a major threat to global health and pose a significant economic burden. Increasing resistance to multiple agents and resistance to so called last-resort antibiotics underscore the necessity to develop therapeutics that have a novel mode of action. DNA replication is a process that can be successfully targeted by small molecules. Ibezapolstat, an inhibitor of the replicative DNA polymerase pol IIIC from Gram-positive bacteria identified by screening library of dGTP analogues, has shown promising results for the treatment of Clostridioides difficile Infection in a recent Phase 2a clinical trial, but the molecular basis of selective inhibition is not fully characterized as no structural information is available on pol IIIC proteins from pathogens. Ongoing research project will determine the structure of pol IIIC from the multidrug-resistant organisms methicillin resistant Staphylococcus aureus (MRSA), vancomycin resistant Enterococci (VRE) and/or penicillin resistant Streptococcus pneumoniae (PRSP) in the absence and presence of lead compounds. These results will reveal the structural space of inhibitor-binding and guide the rational design of inhibitors with optimal pharmacological properties and organism-specificity that will be demonstrated by in vitro polymerase inhibition assays and in vivo minimal inhibitory concentration determination. The presented research was performed in part as a public-private partnership that includes the Dutch Top Sector Life Sciences and Health ('Topconsortium voor Kennis en Innovatie' or 'TKI' Life Sciences and Health) and is represented by Stichting Life Sciences Health – TKI (aka, Health~Holland). This foundation is tasked by the Dutch government to promote and stimulate public-private partnerships (PPPs) to undertake R&D projects in the life sciences. To promote such partnerships, the Minister of Economic Affairs and Climate Policy has allocated certain funds to Stichting LSH-TKI, to grant allowances to projects under the TKI-programme Life Sciences & Health. Stichting LSH-TKI has designated the Board of Directors of LUMC as delegated grantor for the PPP allowance allocated to the LUMC. Together with Acurx Pharmaceuticals the PPP has led to the research project entitled "Bad bugs, new drugs: elucidation of the structure of DNA polymerase C of multidrug resistant bacteria in complex with novel classes of antimicrobials." The collaboration project was co-funded by the PPS Allowance made available by Health~Holland, Top Sector Life Sciences & Health, to stimulate public-private partnerships. __________ Acurx 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. About Ibezapolstat 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. In June 2018, ibezapolstat was designated by the U.S. Food and Drug Administration (FDA) as a Qualified Infectious Disease Product (QIDP) for the treatment of patients with CDI and will be eligible to benefit from the incentives for the development of new antibiotics established under the Generating New Antibiotic Incentives Now (GAIN) Act. In 2019, FDA granted "Fast Track" designation to ibezapolstat for the treatment of patients with CDI. The CDC has designated C. difficile as an urgent threat highlighting the need for new antibiotics to treat CDI. About Clostridioides difficile Infection (CDI) and Recurrent C. difficile Infection (rCDI) According to the 2017 Update (published February 2018) of the Clinical Practice Guidelines for C. difficile Infection by the Infectious Diseases Society of America (IDSA) and Society or Healthcare Epidemiology of America (SHEA), CDI remains a significant medical problem in hospitals, in long-term care facilities and in the community. C. difficile is one of the most common causes of health care-associated infections in U.S. hospitals (Lessa, 2015, NEJM). Recent estimates suggest C. difficile approaches 500,000 infections annually in the U.S. and is associated with approximately 30,000 deaths annually. (Guh, 2020, NEJM. Based on internal estimates, the recurrence rate for the antibiotics currently used to treat CDI is between 20% and 40% among approximately 150,000 patients treated. We believe the annual incidence of CDI in the U.S. approaches 600,000 infections and a mortality rate of approximately 9.3%. In recent studies, rCDI ranges from 4 to 19.5% following treatment with fidaxomicin and 17 to 27% following treatment with vancomycin. In patients with multiple prior episodes of CDI, rCDI following treatment with vancomycin is even more problematic, with an incidence of up to 40%. Consequently, the principal unmet medical need in this disease is the prevention of recurrence. The estimated annual public health cost burden in the U.S. annually is ~$5 billion annually with ~$2.8 billion due to recurrent CDI. About the Microbiome in C. difficile Infection and Bile Acid Metabolism C. difficile can be a normal component of the healthy gut microbiome, but when the microbiome is thrown out of balance, the C. difficile can thrive and cause an infection. After colonization with C. difficile, the organism produces and releases the main virulence factors, the two large clostridial toxins A (TcdA) and B (TcdB). (Kachrimanidou, Microorganisms 2020.) TcdA and TcdB are exotoxins that bind to human intestinal epithelial cells and are responsible for inflammation, fluid and mucous secretion, as well as damage to the intestinal mucosa. Bile acids perform many functional roles in the GI tract, with one of the most important being maintenance of a healthy microbiome by inhibiting C. difficile growth. Primary bile acids, which are secreted by the liver into the intestines, promote germination of C. difficile spores and thereby increase the risk of recurrent CDI after successful treatment of an initial episode. On the other hand, secondary bile acids, which are produced by normal gut microbiota through metabolism of primary bile acids, do not induce C. difficile sporulation and therefore protect against recurrent disease. Since ibezapolstat treatment leads to minimal disruption of the gut microbiome, bacterial production of secondary bile acids continues which may contribute to an anti-recurrence effect. Beneficial effects of bile acids include a decrease in primary bile acids and an increase in secondary bile acids in patients with CDI, which was observed in the Company's Ph2a trial results and previously reported (Garey, CID, 2022). In the Ph2b trial, ibezapolstat-treated patients showed lower concentrations of fecal primary bile acids, and higher beneficial ratio of secondary to primary bile acids than vancomycin-treated patients. About Acurx Pharmaceuticals, Inc. Acurx Pharmaceuticals is a late-stage biopharmaceutical company focused on developing a new class of small molecule antibiotics for difficult-to-treat bacterial infections. The Company's approach is to develop antibiotic candidates with a Gram-positive selective spectrum (GPSS®) that blocks the active site of the Gram-positive specific bacterial enzyme DNA polymerase IIIC (pol IIIC), inhibiting DNA replication and leading to Gram-positive bacterial cell death. Its R&D pipeline includes antibiotic product candidates that target Gram-positive bacteria, including Clostridioides difficile, methicillin- resistant Staphylococcus aureus (MRSA), vancomycin resistant Enterococcus (VRE), drug- resistant Streptococcus pneumoniae (DRSP) and B. anthracis (anthrax; a Bioterrorism Category A Threat-Level pathogen). Acurx's lead product candidate, ibezapolstat, for the treatment of C. difficile Infection is Phase 3 ready with plans in progress to begin international clinical trials next year. The Company's preclinical pipeline includes development of an oral product candidate for treatment of ABSSSI (Acute Bacterial Skin and Skin Structure Infections), upon which a development program for post-exposure prophylaxis of inhalation anthrax is being planned in parallel. To learn more about Acurx Pharmaceuticals and its product pipeline, please visit www.acurxpharma.com. Forward-Looking Statements Any statements in this press release about our future expectations, plans and prospects, including statements regarding our strategy, future operations, prospects, plans and objectives, and other statements containing the words "believes," "anticipates," "plans," "expects," and similar expressions, constitute forward-looking statements within the meaning of The Private Securities Litigation Reform Act of 1995. Actual results may differ materially from those indicated by such forward-looking statements as a result of various important factors, including: whether ibezapolstat will benefit from the QIDP designation; whether ibezapolstat will advance through the clinical trial process on a timely basis; whether the results of the clinical trials of ibezapolstat will warrant the submission of applications for marketing approval, and if so, whether ibezapolstat will receive approval from the FDA or equivalent foreign regulatory agencies where approval is sought; whether, if ibezapolstat obtains approval, it will be successfully distributed and marketed; and other risks and uncertainties described in the Company's quarterlyreport on Form 10-Q filed with the Securities and Exchange Commission on for the quarter ended March 31, 2026, and in the Company's subsequent filings with the Securities and Exchange Commission. Such forward- looking statements speak only as of the date of this press release, and Acurx disclaims any intent or obligation to update these forward-looking statements to reflect events or circumstances after the date of such statements, except as may be required by law. Investor Contact: Acurx Pharmaceuticals, Inc.;David P. Luci, President & CEOTel: 917-533-1469;Email: [email protected] View original content:https://www.prnewswire.com/news-releases/acurx-pharmaceuticals-announces-presentation-of-results-from-leiden-university-medical-center-public-private-partnership-for-its-dna-pol-iiic-inhibitors-at-the-leiden-early-drug-discovery--development-led3-scientific-conference-302801163.html

Our analysts just identified a stock with the potential to be the next Nvidia. Tell us how you invest and we'll show you why it's our #1 pick. Tap here. Management is transitioning the ibezapolstat program to address both acute and recurrent C. difficile (CDI) as a single-agent solution, aiming to replace the current two-agent treatment model. The strategic shift is supported by Phase II data showing a 96% cure rate and zero recurrences in cured patients, suggesting a unique ability to spare the microbiome. A new open-label pilot study in multiply recurrent CDI (rCDI) has been launched to inform the design of a planned Phase III registration trial under the FDA's Limited Population Pathway. The company is leveraging recent FDA guidance that may allow for a single pivotal trial for marketing approval, potentially accelerating the timeline for the acute CDI population. Intellectual property was significantly bolstered with new patents in the U.S. and Korea, extending protection for DNA polymerase IIIC inhibitors through at least 2039. Preclinical data presented at ESCMID Global suggests the company's PolC inhibitor compounds can treat resistant gram-positive infections while maintaining microbial diversity similar to baseline. Acurx has scheduled a meeting with the FDA to confirm if ibezapolstat qualifies for the new one-trial registration standard based on existing 'confirmatory evidence' of efficacy. The 20-patient open-label rCDI trial is expected to see its first patient enrollment around August 2026, serving as a precursor to a pivotal Phase III trial. Management is actively pursuing diverse funding opportunities to support the international Phase III clinical trial program for acute CDI. Future clinical protocols will emphasize patient diversity and consistency across subgroups to align with FDA preferences for single-trial approval pathways. The company plans to follow patients for two months post-treatment in upcoming trials to establish a competitive advantage over current standards that typically only measure one-month recurrence. The company closed a registered direct offering in April 2026, which, combined with an existing equity line of credit, provides the resources necessary for the exploratory rCDI trial. R&D expenses decreased to $0.3 million from $0.6 million year-over-year, primarily due to lower manufacturing and consulting costs following prior year trial preparations. Management acknowledged the challenging macroeconomic environment and industry sector volatility as ongoing factors they must navigate during the Phase III transition. The company maintains QIDP and Fast Track designations from the FDA, which provide regulatory incentives for their antibiotic pipeline. One stock. Nvidia-level potential. 30M+ investors trust Moby to find it first. Get the pick. Tap here. Management clarified that while the guidance is finalized for the industry, they must still confirm its specific application to ibezapolstat in an upcoming FDA meeting. The company believes they meet the 'confirmatory evidence' criteria through mechanistic data, in vitro killing data, and animal models that have historically predicted human efficacy. While microbiome data is currently an exploratory marker rather than a primary approvable claim, it serves as critical evidence for the drug's mechanism in reducing recurrence. Ibezapolstat is designed to be 'gentler' on good bacteria that produce bile acids, which naturally suppress C. diff growth, unlike broader antibiotics like vancomycin. The Phase III trial will follow patients for 8 weeks to match the claims of live biological products like VOWST, rather than the 4-week standard for traditional antibiotics. The company is expanding its study population to include diverse age, geographic, and ethnic groups to satisfy FDA requirements for a single-trial approval pathway.

STATEN ISLAND, N.Y., May 12, 2026 /PRNewswire/ -- Acurx Pharmaceuticals, Inc. (NASDAQ: ACXP) ("Acurx" or the "Company"), a late-stage biopharmaceutical company developing a new class of antibiotics for difficult-to-treat bacterial infections, announced today certain financial and operational results for the first quarter ended March 31, 2026. Highlights of the first quarter ended March 31, 2026, or in some cases shortly thereafter, include: In February 2026, we announced that the USPTO granted a new patent for our DNA pol IIIC inhibitors covering composition of matter and method of use. This patent extends to December 2039, subject to extension under US patent rules. This adds to our extensive patent estate for our DNA pol IIIC inhibitors going out in some cases to 2042, subject to extension. In March 2026, we issued a press release announcing that we are starting up a ground-breaking ibezapolstat (IBZ) clinical trial program in patients with recurrent CDI (rCDI) that has the potential to shift the paradigm of treatment and prevention of rCDI from two agents to one. When coupled with IBZ Phase 2 results of being highly effective (96% clinical cure) in treating acute CDI with 0% recurrence in patients cured of their infection while sparing the gut microbiome, this new clinical trial strategy has the potential to position ibezapolstat to be a new standard of care as the first agent to treat both (acute) CDI and prevent rCDI. This new Phase 2 clinical trial in rCDI builds on ibezapolstat's strength, namely that no patients who were cured of their infection experienced a recurrence. This new trial begins with an open-label pilot study to gain experience with IBZ in up to 20 patients patients with multiply-recurrent CDI who had 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 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. Acurx's clinical program in the broader acute CDI patient population is ready to advance to Phase 3 international pivotal clinical trials. In this regard, we're very excited about the FDA's recent announcement published in the New England Journal of Medicine '…that a one-trial requirement will be FDA's new default standard [i.e., for registration]'. If formalized by FDA, this would end the long-standing two-trial dogma. We look forward to FDA's further clarification and the potentially favorable implications to our clinical development programs, such as the opportunity to seek marketing approval for the broader CDI population with one pivotal clinical trial. In March 2026, we announced that the Korean Patent Office granted a new patent which covers DNA pol IIIC inhibitors including compositions of matter, methods of use, and pharmaceutical compositions, which further strengthen Acurx's intellectual property portfolio and represents the most recent addition to its expanding series of granted patents in the U.S. and internationally. To date, Acurx has secured ten patents including five U.S. patents along with patents in Israel, Japan, India, Australia and Korea, all of which protect key aspects of the Company's product pipeline. Also, and very significantly, a new patent was recently issued relating to IBZ and its use to treat CDI while reducing the recurrence of the infection, as well as improving the health of the gut microbiome. Additional country level patent applications remain under review. In April 2026, the Company announced the closing of a registered direct offering of 825,085 shares of its common stock (or pre-funded warrants in lieu thereof) at a purchase price of $3.03 per share (or pre-funded warrant in lieu thereof) priced at-the-market under Nasdaq rules. In addition, in a concurrent private placement, the Company issued unregistered short-term warrants to purchase up to 1,650,170 shares of common stock. The short-term warrants have an exercise price of $2.78 per share, and are immediately exercisable upon issuance and will expire twenty-four months following the effective date of the registration statement registering the resale of the shares of common stock underlying the short-term warrants. This additional funding when coupled with the remaining availability under our Equity Line of Credit ensures that the Company has the financial resource to conduct the exploratory clinical trial in recurrent C. difficile infection. In April 2026, a scientific poster was presented at the 35th Congress of ESCMID Global (European Society of Clinical Microbiology and Infectious Diseases) held in Munich, Germany from April 17-21, 2026 showing that Acurx's orally absorbed DNA pol IIIC inhibitors in preclinical development have the unexpected benefit of gut microbiome preservation while demonstrating systemic antibacterial activity. Dr. Khurshida Begum, Research Scientist, University of Houston College of Pharmacy presented the poster demonstrating potentially therapeutic plasma levels, reduction of MRSA tissue burden and maintaining a substantially higher gut microbial diversity and community structure similar to baseline and distinct from linezolid. First Quarter 2026 Financial Results Cash Position: The Company ended the quarter with cash totaling $9.3 million, compared to $7.6 million as of December 31, 2025. During the quarter, the Company raised a total of approximately $3.1 million of gross proceeds through purchases under the Equity Line of Credit. R&D Expenses: Research and development expenses for the three months ended March 31, 2026 were $0.3 million compared to $0.6 million for the three months ended March 31, 2025, a decrease of $0.3 million. The decrease was due primarily to a decrease in manufacturing costs of $0.1 million, and a decrease in consulting costs of $0.2 million as a result of the prior year trial preparation related expenses. G&A Expenses: General and administrative expenses for the three months ended March 31, 2026 were $1.4 million compared to $1.6 million for the three months ended March 31, 2025, a decrease of $0.2 million. The decrease was primarily due to a $0.1 million decrease in professional fees and a $0.1 million decrease in legal costs. Net Income/Loss: The Company reported a net loss of $1.7 million or $0.62 per diluted share for the three months ended March 31, 2026 compared to a net loss of $2.1 million or $2.15 per diluted share for the three months ended March 31, 2025, all for the reasons previously mentioned. The Company had 3,389,106 shares outstanding as of March 31, 2026. Conference Call As previously announced, David P. Luci, President and Chief Executive Officer, and Robert G. Shawah, Chief Financial Officer, will host a conference call to discuss the results and provide a business update as follows: Date: Tuesday, May 12, 2026 Time: 8:00 a.m. ET Toll free (U.S.): 1-877-790-1503; Access ID: 13760162 International: Click here for participant international Toll-Free access numbers https://www.incommconferencing.com/international-dial-in About Ibezapolstat Ibezapolstat is the Company's lead antibiotic candidate preparing for advancement into international Phase 3 clinical trials to treat patients with acute C. difficile Infection (CDI) and it is also preparing for a ground-breaking clinical trial targeting the prevention of recurrent CDI (rCDI). If successful, ibezapolstat will change the treatment paradigm for CDI and rCDI by providing one therapy for the full spectrum of CDI and rCDI from first occurrence to multiply recurrent episodes. 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. As previously announced, the Company has received final EMA and FDA agreement for our ibezapolstat pivotal Phase 3 trials in CDI. Their advice included and confirmed the non-inferiority study design elements, the patient population, primary and secondary endpoints, and size of the registration safety database. Acurx also now has a clear international roadmap for conduct of its Phase 3 program in CDI and, if successful, requirements for US NDA submission and EU Marketing Authorization. In June 2018, ibezapolstat was designated by the U.S. Food and Drug Administration (FDA) as a Qualified Infectious Disease Product (QIDP) for the treatment of patients with CDI and will be eligible to benefit from the incentives for the development of new antibiotics established under the Generating New Antibiotic Incentives Now (GAIN) Act. In January 2019, FDA granted "Fast Track" designation to ibezapolstat for the treatment of patients with CDI. The CDC has designated C. difficile as an urgent threat highlighting the need for new antibiotics to treat CDI. About Acurx Pharmaceuticals, Inc. Acurx Pharmaceuticals is a late-stage biopharmaceutical company focused on developing a new class of small molecule antibiotics for difficult-to-treat bacterial infections. The Company's approach is to develop antibiotic candidates with a Gram-positive selective spectrum (GPSS®) that blocks the active site of the Gram+ specific bacterial enzyme DNA polymerase IIIC (pol IIIC), inhibiting DNA replication and leading to Gram-positive bacterial cell death. Its R&D pipeline includes antibiotic product candidates that target Gram-positive bacteria, including Clostridioides difficile, methicillin- resistant Staphylococcus aureus (MRSA), vancomycin resistant Enterococcus (VRE), drug- resistant Streptococcus pneumoniae (DRSP) and B. anthracis (anthrax; a Bioterrorism Category A Threat-Level pathogen). Acurx's lead product candidate, ibezapolstat, for the treatment of C. difficile Infection (CDI) is Phase 3 ready to advance to international clinical trials subject to obtaining appropriate financing. The Company recently announced the launch of a ground-breaking clinical trial with ibezapolstat in patients with multiply-recurrent CDI (rCDI) that has the potential to shift the paradigm of treatment and prevention of rCDI from two agents to one. 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). The Company's preclinical pipeline includes development of an oral product candidate for treatment of ABSSSI (Acute Bacterial Skin and Skin Structure Infections), upon which a development program for treatment of inhaled anthrax is being planned in parallel. To learn more about Acurx Pharmaceuticals and its product pipeline, please visit www.acurxpharma.com. Forward-Looking Statements Any statements in this press release about our future expectations, plans and prospects, including statements regarding our strategy, future operations, prospects, plans and objectives, and other statements containing the words "believes," "anticipates," "plans," "expects," and similar expressions, constitute forward-looking statements within the meaning of The Private Securities Litigation Reform Act of 1995. Actual results may differ materially from those indicated by such forward-looking statements as a result of various important factors, including: whether ibezapolstat will benefit from the QIDP designation; whether ibezapolstat will advance through the clinical trial process on a timely basis; whether the results of the clinical trials of ibezapolstat will warrant the submission of applications for marketing approval, and if so, whether ibezapolstat will receive approval from the FDA or equivalent foreign regulatory agencies where approval is sought; whether, if ibezapolstat obtains approval, it will be successfully distributed and marketed; and other risks and uncertainties described in the Company's annual report filed with the Securities and Exchange Commission on Form 10-K for the year ended December 31, 2025, and in the Company's subsequent filings with the Securities and Exchange Commission. Such forward- looking statements speak only as of the date of this press release, and Acurx disclaims any intent or obligation to update these forward-looking statements to reflect events or circumstances after the date of such statements, except as may be required by law. Investor Contact: Acurx Pharmaceuticals, Inc. David P. Luci President & Chief Executive Officer Tel: 917-533-1469 Email: [email protected] View original content:https://www.prnewswire.com/news-releases/acurx-pharmaceuticals-inc-reports-first-quarter-2026-results-and-provides-business-update-302765686.html

STATEN ISLAND, N.Y., April 20, 2026 /PRNewswire/ -- Acurx Pharmaceuticals, Inc. (NASDAQ: ACXP) ("Acurx" or the "Company"), a late-stage biopharmaceutical company developing a new class of antibiotics for difficult-to-treat bacterial infections, announced today that the Company will discuss its first quarter 2026 financial results on Tuesday, May 12, 2026 at 8:00 am ET before the U.S. financial markets open. David P. Luci, President and Chief Executive Officer, and Robert G. Shawah, Chief Financial Officer, will host a conference call to discuss the results and provide a business update as follows: Click here for participant International Toll-Free access numbers About Ibezapolstat Ibezapolstat is the Company's lead antibiotic candidate preparing for advancement into international Phase 3 clinical trials to treat patients with acute C. difficile Infection (CDI) and it is also preparing for a ground-breaking clinical trial targeting the prevention of recurrent CDI (rCDI). If successful, ibezapolstat will change the treatment paradigm for CDI and rCDI by providing one therapy for the full spectrum of CDI and rCDI from first occurrence to multiply recurrent episodes. Ibezapolstat is a novel, orally administered antibiotic being developed as a Gram-Positive Selective Spectrum (GPSSﾮ) 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. As previously announced, the Company has received final EMA and FDA agreement for our ibezapolstat pivotal Phase 3 trials in CDI. Their advice included and confirmed the non-inferiority study design elements, the patient population, primary and secondary endpoints, and size of the registration safety database. Acurx also now has a clear international roadmap for conduct of its Phase 3 program in CDI and, if successful, requirements for US NDA submission and EU Marketing Authorization. About Acurx Pharmaceuticals, Inc. Acurx Pharmaceuticals is a late-stage biopharmaceutical company focused on developing a new class of small molecule antibiotics for difficult-to-treat bacterial infections. The Company's approach is to develop antibiotic candidates with a Gram-positive selective spectrum (GPSSﾮ) that blocks the active site of the Gram-positive specific bacterial enzyme DNA polymerase IIIC (pol IIIC), inhibiting DNA replication and leading to Gram-positive bacterial cell death. Its R&D pipeline includes antibiotic product candidates that target Gram-positive bacteria, including Clostridioides difficile, methicillin- resistant Staphylococcus aureus (MRSA), vancomycin resistant Enterococcus (VRE), drug- resistant Streptococcus pneumoniae (DRSP) and B. anthracis (anthrax; a Bioterrorism Category A Threat-Level pathogen). Acurx's lead product candidate, ibezapolstat, for the treatment of C. difficile Infection is Phase 3 ready with plans in progress to begin international clinical trials as soon as possible. The Company's preclinical pipeline includes development of an oral product candidate for treatment of ABSSSI (Acute Bacterial Skin and Skin Structure Infections), upon which a development program for treatment of inhaled anthrax is being planned in parallel. To learn more about Acurx Pharmaceuticals and its product pipeline, please visit www.acurxpharma.com Forward-Looking Statements Any statements in this press release about our future expectations, plans and prospects, including statements regarding our strategy, future operations, prospects, plans and objectives, and other statements containing the words "believes," "anticipates," "plans," "expects," and similar expressions, constitute forward-looking statements within the meaning of The Private Securities Litigation Reform Act of 1995. Actual results may differ materially from those indicated by such forward-looking statements as a result of various important factors, including: whether ibezapolstat will benefit from the QIDP designation; whether ibezapolstat will advance through the clinical trial process on a timely basis; whether the results of the clinical trials of ibezapolstat will warrant the submission of applications for marketing approval, and if so, whether ibezapolstat will receive approval from the FDA or equivalent foreign regulatory agencies where approval is sought; whether, if ibezapolstat obtains approval, it will be successfully distributed and marketed; and other risks and uncertainties described in the Company's annual report filed with the Securities and Exchange Commission on Form 10-K for the year ended December 31, 2025, and in the Company's subsequent filings with the Securities and Exchange Commission. Such forward- looking statements speak only as of the date of this press release, and Acurx disclaims any intent or obligation to update these forward-looking statements to reflect events or circumstances after the date of such statements, except as may be required by law. Investor Contact: Acurx Pharmaceuticals, Inc. David P. Luci, President & CEO Tel: 917-533-1469 Email: [email protected] View original content:https://www.prnewswire.com/news-releases/acurx-pharmaceuticals-to-discuss-first-quarter-2026-financial-results-on-may-12-2026-conference-call-and-provide-business-update-302745436.html

This article first appeared on GuruFocus. Cash Position: Ended the year with $7.6 million compared to $3.7 million as of December 31, 2024. Equity Line of Credit Proceeds: Raised approximately $1.5 million during the quarter and $4 million for the full year 2025. Research and Development Expenses (Q4 2025): $0.3 million, a decrease from $0.8 million in Q4 2024. Research and Development Expenses (Full Year 2025): $1.8 million, down from $5.4 million in 2024. General and Administrative Expenses (Q4 2025): $1.3 million, down from $2 million in Q4 2024. General and Administrative Expenses (Full Year 2025): $6.3 million, a decrease from $8.7 million in 2024. Net Loss (Q4 2025): $1.6 million or $0.73 per diluted share, compared to $2.8 million or $3.29 per diluted share in Q4 2024. Net Loss (Full Year 2025): $8 million or $5.32 per diluted share, compared to $14.1 million or $17.45 per share in 2024. Shares Outstanding: 2,348,113 as of December 31, 2025. Warning! GuruFocus has detected 1 Warning Sign with ACXP. Is ACXP fairly valued? Test your thesis with our free DCF calculator. Release Date: March 13, 2026 For the complete transcript of the earnings call, please refer to the full earnings call transcript. Acurx Pharmaceuticals Inc (NASDAQ:ACXP) received approximately $1.4 million from the execution of Series F Warrants, boosting their financial resources. The company presented promising microbiome-sparing data at IDWeek, highlighting the potential of their DNA pol IIIC inhibitor pipeline. A new patent for Pol IIIC inhibitors was granted, extending protection until December 2039, which strengthens their intellectual property portfolio. Ibezapolstat showed a 96% clinical cure rate in Phase II trials for C. difficile infection, with no recurrence in patients, indicating strong efficacy. The company ended 2025 with $7.6 million in cash, a significant increase from $3.7 million at the end of 2024, reflecting improved financial stability. Acurx Pharmaceuticals Inc (NASDAQ:ACXP) reported a net loss of $1.6 million for Q4 2025, although this was an improvement from the previous year. Research and development expenses decreased significantly, which could indicate a slowdown in new project initiation or progression. The company is still in the early stages of their ibezapolstat clinical trial program for recurrent CDI, with full enrollment expected to take 12 to 15 months. There is uncertainty regarding the FDA's new one-trial requirement, which could impact the timeline and strategy for clinical trials. The company relies on external funding opportunities and alternative financial pathways to support their Phase III clinical trial program, indicating potential financial constraints. Q: For the new recurrent CDI trial, what is the primary endpoint, and how long will patients be observed? What is the cost of the trial? A: Michael Silverman, Medical Director: The primary endpoint is the prevention of recurrence, assessed at eight weeks post-treatment. Patients will be followed for approximately six months to gather additional data. David Luci, CEO: The trial is estimated to cost between $4 million to $5 million. Q: How does the recurrence rate of CDI compare between ibezapolstat and other treatments like vancomycin? A: Michael Silverman, Medical Director: Vancomycin shows recurrence rates between 20% and 40%, while anti-recurrence therapies have rates between 15% and 30% at eight weeks. We aim to demonstrate lower recurrence rates with ibezapolstat. Q: Can the current cash balance support the pilot study for recurrent CDI, and when will it start? A: David Luci, CEO: Yes, with potential additional funding from our Equity Line of Credit, we can support the study. Enrollment is expected to start in the second half of 2026, with full enrollment anticipated in 12 to 15 months. Q: If the pilot study is successful, how might it affect the size of the Phase III trial for recurrent CDI? A: Michael Silverman, Medical Director: We currently estimate a single trial for recurrent CDI would require between 360 and 400 patients, depending on the data from the pilot study. Q: How important is U.S.-based manufacturing for ibezapolstat, and is there potential for government stockpiling? A: David Luci, CEO: U.S.-based manufacturing is crucial for government partnerships, including discussions with BARDA. The stability of ibezapolstat makes it suitable for stockpiling, which is of interest to government agencies. For the complete transcript of the earnings call, please refer to the full earnings call transcript.

STATEN ISLAND, N.Y., March 13, 2026 /PRNewswire/ -- Acurx Pharmaceuticals, Inc. (NASDAQ: ACXP) ("Acurx" or the "Company"), a late-stage biopharmaceutical company developing a new class of antibiotics for difficult-to-treat bacterial infections, announced today certain financial and operational results for the full year and fourth quarter ended December 31, 2025. Highlights of the fourth quarter ended December 31, 2025, or in some cases shortly thereafter, include: In October 2025, the Company received gross proceeds from the exercise of 170,068 Series F Warrants of approximately $1.4 million. Also in October 2025, we were one of five companies to make a formal presentation at IDWeek in Atlanta at the session entitled New Antimicrobials in the Pipeline. Presenting on behalf of Acurx were Dr. Michael Silverman, our Medical Director, and Dr. Kevin Garey, Professor and Chair, University of Houston College of Pharmacy and the Principal Investigator for microbiology and microbiome aspects of the ibezapolstat clinical trial program. The Company's presentation included an update on ibezapolstat and its microbiome sparing properties. Also, presented were new colonic-microbiome data from a "state-of-the-art" mouse infection model showing a potential microbiome-sparing class effect of representative compounds from our DNA pol IIIC inhibitor preclinical pipeline. In November 2025, the Company announced that the Nature Communications Scientific Journal published results from its scientific collaboration with Leiden University Medical Center (LUMC) demonstrating structural biology research that reveals for the first time a DNA pol IIIC inhibitor, ibezapolstat, bound to its target. The publication is entitled: "A unique inhibitor conformation selectively targets the DNA polymerase PolC of Gram-positive priority pathogens." This is an important milestone in Acurx's highly productive scientific collaboration with LUMC in advancing development of these "new-to-nature" compounds fortifying the foundation for the rational development of this innovative class of antimicrobials against other Gram-positive priority pathogens. In February 2026, we announced that the USPTO granted a new patent for our Pol IIIC inhibitors covering composition of matter and method of use. This patent extends to December 2039, subject to extension under US patent rules. On March 9, 2026 we issued a press release announcing that we are launching a ground-breaking ibezapolstat clinical trial program in patients with recurrent CDI (or rCDI) that has the potential to shift the paradigm of treatment and prevention of rCDI from two agents to one. When coupled with ibezapolstat ("IBZ") Phase 2 results of being highly effective (96% clinical cure of 26 patients) in treating acute CDI with no recurrence in patients while sparing the gut microbiome, this new trial will position ibezapolstat as a candidate to be the first agent to demonstrate clinical success in both the treatment of CDI and the prevention of rCDI. 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 published in 2020). Acurx's clinical program in the broader CDI patient population is ready to Advance to Phase 3 international pivotal clinical trials. In this regard, we are very excited about the FDA's recent announcement published in the New England Journal of Medicine '…that a one-trial requirement will be FDA's new default standard [that is, for registration]'. If formalized, this would end the long-standing two-trial Phase 3 trial dogma. We look forward to FDA's further clarification and the potentially favorable implications to our clinical development programs, such as the opportunity to seek marketing approval for the broader CDI population with one pivotal clinical trial. Full Year and Fourth Quarter and 2025 Financial Results Cash Position: The Company ended the quarter with cash totaling $7.6 million, compared to $3.7 million as of December 31, 2024. During the fourth quarter, the Company raised a total of approximately $1.5 million of gross proceeds through purchases under the Equity Line of Credit, with gross proceeds of purchases under the Equity Line of Credit totaling approximately $4.0 million for the full year. R&D Expenses: Research and development expenses for the three months ended December 31, 2025 were $0.3 million compared to $0.8 million for the three months ended December 31, 2024, a decrease of $0.5 million. The decrease was due primarily to a decrease in manufacturing costs of $0.2 million, and a decrease in consulting costs of $0.3 million as a result of the prior year trial-related expenses. For the twelve months ended December 31, 2025, research & development expenses were $1.8 million versus $5.4 million for the twelve months ended December 31, 2024. The decrease of $3.6 million was primarily due to a reduction of $2.6 million in manufacturing costs, and a $1.0 million decrease in consulting costs as prior year had higher expenses related to Phase 2b and Phase 3 preparation costs. G&A Expenses: General and administrative expenses for the three months ended December 31, 2025 were $1.3 million compared to $2.0 million for the three months ended December 31, 2024, a decrease of $0.7 million. The decrease was primarily due to a $0.3 million decrease in compensation-related costs and a $0.3 million decrease in professional fees. For the twelve months ended December 31, 2025, general & administrative expenses were $6.3 million versus $8.7 million for the twelve months ended December 31, 2024, a decrease of $2.4 million. The decrease was primarily due to a $0.9 million decrease in professional fees and a $1.4 million decrease in share-based compensation and a $0.4 million decrease in compensation costs, offset by a $0.3 million increase in legal costs. Net Income/Loss: The Company reported a net loss of $1.6 million or $0.73 per diluted share for the three months ended December 31, 2025 compared to a net loss of $2.8 million or $3.29 per diluted share for the three months ended December 31, 2024, and a net loss of $8.0 million or $5.32 per diluted share for the twelve months ended December 31, 2025, compared to a net loss of $14.1 million or $17.45 per share for the twelve months ended December 31, 2024, all for the reasons previously mentioned. The Company had 2,348,113 shares outstanding as of December 31, 2025. Conference Call As previously announced, David P. Luci, President and Chief Executive Officer, and Robert G. Shawah, Chief Financial Officer, will host a conference call to discuss the results and provide a business update as follows: About Ibezapolstat Ibezapolstat is the Company's lead antibiotic candidate preparing for international Phase 3 clinical trials to treat patients with C. difficile Infection (CDI). 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. Acurx 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 In June 2018, ibezapolstat was designated by the U.S. Food and Drug Administration (FDA) as a Qualified Infectious Disease Product (QIDP) for the treatment of patients with CDI and will be eligible to benefit from the incentives for the development of new antibiotics established under the Generating New Antibiotic Incentives Now (GAIN) Act. In January 2019, FDA granted "Fast Track" designation to ibezapolstat for the treatment of patients with CDI. The CDC has designated C. difficile as an urgent threat highlighting the need for new antibiotics to treat CDI. About Acurx Pharmaceuticals, Inc. Acurx Pharmaceuticals is a late-stage biopharmaceutical company focused on developing a new class of small molecule antibiotics for difficult-to-treat bacterial infections. The Company's approach is to develop antibiotic candidates with a Gram-positive selective spectrum (GPSS®) that blocks the active site of the Gram+ specific bacterial enzyme DNA polymerase IIIC (pol IIIC), inhibiting DNA replication and leading to Gram-positive bacterial cell death. Its R&D pipeline includes antibiotic product candidates that target Gram-positive bacteria, including Clostridioides difficile, methicillin- resistant Staphylococcus aureus (MRSA), vancomycin resistant Enterococcus (VRE), drug- resistant Streptococcus pneumoniae (DRSP) and B. anthracis (anthrax; a Bioterrorism Category A Threat-Level pathogen). Acurx's lead product candidate, ibezapolstat, for the treatment of C. difficile Infection(CDI) is Phase 3 ready to advance to international clinical trials subject to obtaining appropriate financing.The Company recently announced the launch of a ground-breaking clinical trial with ibezapolstat in patients with multiply-recurrent CDI (rCDI) that has the potential to shift the paradigm of treatment and prevention of rCDI from two agents to one. 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). The Company's preclinical pipeline includes development of an oral product candidate for treatment of ABSSSI (Acute Bacterial Skin and Skin Structure Infections), upon which a development program for treatment of inhaled anthrax is being planned in parallel. To learn more about Acurx Pharmaceuticals and its product pipeline, please visit www.acurxpharma.com. Forward-Looking Statements Any statements in this press release about our future expectations, plans and prospects, including statements regarding our strategy, future operations, prospects, plans and objectives, and other statements containing the words "believes," "anticipates," "plans," "expects," and similar expressions, constitute forward-looking statements within the meaning of The Private Securities Litigation Reform Act of 1995. Actual results may differ materially from those indicated by such forward-looking statements as a result of various important factors, including: whether ibezapolstat will benefit from the QIDP designation; whether ibezapolstat will advance through the clinical trial process on a timely basis; whether the results of the clinical trials of ibezapolstat will warrant the submission of applications for marketing approval, and if so, whether ibezapolstat will receive approval from the FDA or equivalent foreign regulatory agencies where approval is sought; whether, if ibezapolstat obtains approval, it will be successfully distributed and marketed; and other risks and uncertainties described in the Company's annual report filed with the Securities and Exchange Commission on Form 10-K for the year ended December 31, 2025, and in the Company's subsequent filings with the Securities and Exchange Commission. Such forward- looking statements speak only as of the date of this press release, and Acurx disclaims any intent or obligation to update these forward-looking statements to reflect events or circumstances after the date of such statements, except as may be required by law. Investor Contact: Acurx Pharmaceuticals, Inc. David P. Luci President & Chief Executive Officer Tel: 917-533-1469 Email: [email protected] View original content:https://www.prnewswire.com/news-releases/acurx-pharmaceuticals-inc-reports-full-year-and-fourth-quarter-results-and-provides-business-update-302712070.html