Q2 2026 Acurx Pharmaceuticals Inc Earnings Call

Speaker #3: Greetings. Welcome to Acurx Pharmaceuticals. To discuss Q2 2026 financial results on August 14, 2026, conference call and provide business update. This time all participants will be in listen-only mode.

Operator: Greetings. Welcome to Acurx Pharmaceuticals to discuss Q2 2026 financial results on 14 August 2026 conference call and provide business update. At this time, all participants will be in listen-only mode. The question and answer session will follow the formal presentation. If anyone should require operator assistance today, please press star zero on your telephone keypad. Please note this conference is being recorded. I will now turn the conference over to Rob Shawah, Chief Financial Officer. Thank you. You may begin.

Operator: Greetings. Welcome to Acurx Pharmaceuticals to discuss Q2 2026 financial results on 14 August 2026 conference call and provide business update. At this time, all participants will be in listen-only mode. The question and answer session will follow the formal presentation. If anyone should require operator assistance today, please press star zero on your telephone keypad. Please note this conference is being recorded. I will now turn the conference over to Rob Shawah, Chief Financial Officer. Thank you. You may begin.

Speaker #3: The question-and-answer session will follow the formal presentation. If anyone should require operator assistance today, please press *0 on your telephone keypad. Please note, this conference is being recorded.

Speaker #3: I'll now turn the conference over to Rob Shawah, Chief Financial Officer. Thank you. You may begin.

Speaker #4: Thank you, Rob. Good morning, and welcome to our call. This morning we issued a press release providing financial results and company highlights for Q2 2026, which is available on our website at acurxpharma.com.

Rob G. Shawah: Thank you, Rob. Good morning and welcome to our call. This morning, we issued a press release providing financial results and company highlights for Q2 2026, which is available on our website at acurxpharma.com. Joining me today is Dave Luci, President and CEO of Acurx, who will start by providing a corporate update and outlook. Following that, I will provide some highlights of the financials from Q2 ended 30 June, and then turn the call back over to Dave for his closing remarks. As a reminder, during today's call, we will be making certain forward-looking statements which are based on current information, assumptions, estimates, and projections about future events that are subject to change and involve a number of risks and uncertainties that may cause actual results to differ materially from those contained in the forward-looking statements.

Rob Shawah: Thank you, Rob. Good morning and welcome to our call. This morning, we issued a press release providing financial results and company highlights for Q2 2026, which is available on our website at acurxpharma.com. Joining me today is Dave Luci, President and CEO of Acurx, who will start by providing a corporate update and outlook. Following that, I will provide some highlights of the financials from Q2 ended 30 June, and then turn the call back over to Dave for his closing remarks. As a reminder, during today's call, we will be making certain forward-looking statements which are based on current information, assumptions, estimates, and projections about future events that are subject to change and involve a number of risks and uncertainties that may cause actual results to differ materially from those contained in the forward-looking statements.

Speaker #4: Joining me today is Dave Luci, President and CEO of Acurx, who will start by providing a corporate update and outlook. Following that, I'll provide some highlights of the financials from Q2 ended June 30, and then turn the call back over to Dave for his closing remarks.

Speaker #4: As a reminder, during today's call we'll be making certain forward-looking statements, which are based on current information, assumptions, estimates, and projections about future events that are subject to change, and involve a number of risks and uncertainties that may cause actual results to differ materially from those contained in the forward-looking statements.

Speaker #4: Investors should consider these risks and other information described in our filings with the Securities and Exchange Commission, including our quarterly report on Form 10-Q, which we filed yesterday, Thursday, August 13.

Rob G. Shawah: Investors should consider these risks and other information described in our filings with the Securities and Exchange Commission, including our quarter report on Form 10-Q, which we filed yesterday, Thursday, 13 August 2026. You are cautioned not to place undue reliance on these forward-looking statements, and Acurx disclaims any obligation to update such statements at any time in the future. This conference call contains time-sensitive information that is accurate only as of the date of this live broadcast, today, 14 August. I will now turn the call over to Dave Luci. Dave?

Rob Shawah: Investors should consider these risks and other information described in our filings with the Securities and Exchange Commission, including our quarter report on Form 10-Q, which we filed yesterday, Thursday, 13 August 2026. You are cautioned not to place undue reliance on these forward-looking statements, and Acurx disclaims any obligation to update such statements at any time in the future. This conference call contains time-sensitive information that is accurate only as of the date of this live broadcast, today, 14 August. I will now turn the call over to Dave Luci. Dave?

Speaker #4: You are cautioned not to place undue reliance on these forward-looking statements, and Acurx disclaims any obligation to update such statements at any time in the future.

Speaker #4: This conference call contains time-sensitive information that's accurate only as of the date of this live broadcast—today, August 14. I'll now turn the call over to Dave Luci.

Speaker #4: Dave?

Speaker #5: Thanks, Rob. Good morning, everyone, and thank you so much for joining us to review our financial results for Q2, and also to hear some recent updates on our continuing progress.

David P. Luci: Thanks, Rob. Good morning, everyone, and thank you so much for joining us to review our financial results for Q2, and also to hear some recent updates on our continuing progress. We would be pleased to take any questions. Our Executive Chairman, Bob DeLucia, and our Medical Director, Dr. Michael Silverman, have joined us today and will be available to answer questions about our recent FDA meeting and our clinical development plan for ibezapolstat, both in recurrent C. diff infection and in acute CDI. First, I would like to briefly summarize just a few of our key activities for Q2 2026, or in some cases, shortly thereafter.

David Luci: Thanks, Rob. Good morning, everyone, and thank you so much for joining us to review our financial results for Q2, and also to hear some recent updates on our continuing progress. We would be pleased to take any questions. Our Executive Chairman, Bob DeLucia, and our Medical Director, Dr. Michael Silverman, have joined us today and will be available to answer questions about our recent FDA meeting and our clinical development plan for ibezapolstat, both in recurrent C. diff infection and in acute CDI. First, I would like to briefly summarize just a few of our key activities for Q2 2026, or in some cases, shortly thereafter.

Speaker #5: Then we'd be pleased to take any questions. Our Executive Chairman, Bob DeLucia, and our Medical Director, Dr. Michael Silverman, have joined us today and will be available to answer questions about our recent FDA meeting and our clinical development plan for ibezaprostat.

Speaker #5: Both in recurrent C. diff infection and in acute CDI. First, I'd like to briefly summarize just a few of our key activities for Q2 2026.

Speaker #5: Or in some cases, shortly thereafter. Last month, 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 in acute CDI.

David P. Luci: Last month 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 III study in acute CDI, and its acceptability as a pivotal trial for filing a New Drug Application, the outcome of which we provided more detail in our 3 August press release. Briefly, the FDA stated that it is open to further discussion on the totality of evidence from the ibezapolstat clinical development program at a pre-NDA meeting after completion of a single phase III trial called IBEZ-ASPIRE, and any other clinical trials conducted prior to the pre-NDA meeting, which will include the Pathfinder study, 20 patients, open label and recurrent CDI, particularly if the clinical efficacy results are robust.

David Luci: Last month 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 III study in acute CDI, and its acceptability as a pivotal trial for filing a New Drug Application, the outcome of which we provided more detail in our 3 August press release. Briefly, the FDA stated that it is open to further discussion on the totality of evidence from the ibezapolstat clinical development program at a pre-NDA meeting after completion of a single phase III trial called IBEZ-ASPIRE, and any other clinical trials conducted prior to the pre-NDA meeting, which will include the Pathfinder study, 20 patients, open label and recurrent CDI, particularly if the clinical efficacy results are robust.

Speaker #5: And its acceptability as a pivotal trial for filing a new drug application, the outcome of which we provided more detail on in our August 3 press release.

Speaker #5: Briefly, the FDA stated that it is open to further discussion on the totality of evidence from the Ibezoprostat clinical development program at a pre-NDA meeting after completion of a single Phase 3 trial.

Speaker #5: Called IBEX Aspire. And any other clinical trials conducted prior to the pre-NDA meeting, which will include the Pathfinder study—20 patients, open label, in recurrent CDI.

Speaker #5: Particularly if the clinical efficacy results are robust. As you may recall from our previous announcements, we've begun startup activities to conduct the 20-patient, groundbreaking Pathfinder study in multiple recurrent CDI.

David P. Luci: As you may recall from our previous announcements, we have begun startup activities to conduct the 20-patient ground-breaking Pathfinder study in mostly recurrent CDI, with enrollment anticipated to start in Q4. This trial was acknowledged by FDA as being significant, and along with robust results from our ASPIRE trial, will form the basis of a potential approval for the treatment of both CDI and for the treatment of CDI and prevention of recurrent CDI. in August 2026, the company received FDA conditional acceptance and USPTO trademark allowance of its proprietary name or brand name for ibezapolstat, which I will share with you now, is Sibesi. These initial milestones will form the basis for the commercial identity of ibezapolstat as the company prepares to advance it towards international phase III registration program and ultimate commercialization.

David Luci: As you may recall from our previous announcements, we have begun startup activities to conduct the 20-patient ground-breaking Pathfinder study in mostly recurrent CDI, with enrollment anticipated to start in Q4. This trial was acknowledged by FDA as being significant, and along with robust results from our ASPIRE trial, will form the basis of a potential approval for the treatment of both CDI and for the treatment of CDI and prevention of recurrent CDI. in August 2026, the company received FDA conditional acceptance and USPTO trademark allowance of its proprietary name or brand name for ibezapolstat, which I will share with you now, is Sibesi. These initial milestones will form the basis for the commercial identity of ibezapolstat as the company prepares to advance it towards international phase III registration program and ultimate commercialization.

Speaker #5: With enrollment anticipated to start in the fourth quarter, this trial was acknowledged by the FDA as being significant and, along with robust results from our Aspire trial, will form the basis of a potential approval for the treatment of both CDI and for the treatment of CDI and prevention of recurrent CDI.

Speaker #5: In August 2026, the company received FDA conditional acceptance and USPTO trademark allowance of its proprietary name, or brand name, for Ibezoprostat, which I'll share with you now: Cifbezi.

Speaker #5: These initial milestones will form the basis for the commercial identity of Ibezoprostat as the company prepares to advance it toward its international Phase 3 registration program and ultimate commercialization.

Speaker #5: Also in July, we signed and announced last week a continuation of our scientific partnership with Leiden University Medical Center to advance development of our DNA POL3C inhibitors.

David P. Luci: Also in July, we signed and announced last week a continuation of our scientific partnership with Leiden University Medical Center to advance development of our DNA Pol IIIC inhibitors. This new partnership builds on the previously reported successful results from the innovative research grant received from the Dutch government in November 2025. This new partnership will enable further mechanistic research into DNA Pol IIIC inhibition to accelerate the development of novel new antibiotics that are systemically active against a wide range of Gram-positive pathogens resistant to currently available antibiotics. This new research also aims to generate the first ever 3D structure of PolC from methicillin-resistant Staph aureus in complex with an Acurx inhibitor to advance discovery of new compounds to treat this high-priority clinical pathogen as designated by the CDC and the FDA.

David Luci: Also in July, we signed and announced last week a continuation of our scientific partnership with Leiden University Medical Center to advance development of our DNA Pol IIIC inhibitors. This new partnership builds on the previously reported successful results from the innovative research grant received from the Dutch government in November 2025. This new partnership will enable further mechanistic research into DNA Pol IIIC inhibition to accelerate the development of novel new antibiotics that are systemically active against a wide range of Gram-positive pathogens resistant to currently available antibiotics. This new research also aims to generate the first ever 3D structure of PolC from methicillin-resistant Staph aureus in complex with an Acurx inhibitor to advance discovery of new compounds to treat this high-priority clinical pathogen as designated by the CDC and the FDA.

Speaker #5: This new partnership builds on the previously reported successful results from the innovative research grant received from the Dutch government in November 2025. This new partnership will enable further mechanistic research into DNA POL3C inhibition to accelerate the development of novel antibiotics that are systemically active against a wide range of gram-positive pathogens, resistant to currently available antibiotics.

Speaker #5: This new research also aims to generate the first-ever 3D structure of POLC from methazoline-resistant Staph aureus and to complex it with an Acurx inhibitor to advance the discovery of new compounds to treat this high-priority clinical pathogen, as designated by the CDC and the FDA.

Speaker #5: In the same month, in July, a presentation of scientific data by Dr. Kevin Garey and his team from his laboratory at the University of Houston College of Pharmacy demonstrated that, following treatment in his state-of-the-art laboratory model with ibezapolstat, the beneficial microorganisms in the gut will have the opportunity to repopulate the microbiome in a beneficial way that prevents recurrence.

David P. Luci: In the same month, in July, a presentation of scientific data by Dr. Kevin Garey and his team from his laboratory at the University of Houston College of Pharmacy demonstrated that following treatment in his state-of-the-art laboratory model with ibezapolstat, the beneficial microorganisms in the gut will have the opportunity to repopulate the microbiome in a beneficial way that prevents recurrence. In addition, ibezapolstat and fidaxomicin were superior in biofilm experimental models with ibezapolstat significantly more effective at killing C. diff than fidaxomicin. Acurx remains prepared to commence its phase III clinical trial program with the ASPIRE trial for the treatment of both CDI and reduction of recurrence, pending appropriate funding from public or private sources or partnerships. Our recent progress and efforts to secure this funding are ongoing.

David Luci: In the same month, in July, a presentation of scientific data by Dr. Kevin Garey and his team from his laboratory at the University of Houston College of Pharmacy demonstrated that following treatment in his state-of-the-art laboratory model with ibezapolstat, the beneficial microorganisms in the gut will have the opportunity to repopulate the microbiome in a beneficial way that prevents recurrence. In addition, ibezapolstat and fidaxomicin were superior in biofilm experimental models with ibezapolstat significantly more effective at killing C. diff than fidaxomicin. Acurx remains prepared to commence its phase III clinical trial program with the ASPIRE trial for the treatment of both CDI and reduction of recurrence, pending appropriate funding from public or private sources or partnerships. Our recent progress and efforts to secure this funding are ongoing.

Speaker #5: In addition, Ibez and Phytax, Phytaxomycin, were superior in biofilm experimental models, with Ibez significantly more effective at killing C. diff than vancomycin and Phytax.

Speaker #5: Acurx remains prepared to commence its Phase 3 clinical trial program with the Aspire trial for the treatment of both CDI and reduction of recurrence, pending appropriate funding from public or private sources or partnerships.

Speaker #5: Our recent progress and efforts to secure this funding are ongoing. I'd also point out that our Pathfinder trial is fully funded and is successful.

David P. Luci: I'd also point out that our PATHFINDER trial is fully funded and, if successful, will elevate the product profile of ibezapolstat, as well as provide significant supportive data for FDA's evaluation. In April, the company announced the closing of a registered direct offering of up to $7.1 million, issuing 825,085 shares of our common stock or pre-funded warrants at a purchase price of $3.03 per share, 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 1.65 million 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 24 months following the effective date of the registration statement, registering resale of the shares of common stock underlying the short-term warrants.

David Luci: I'd also point out that our PATHFINDER trial is fully funded and, if successful, will elevate the product profile of ibezapolstat, as well as provide significant supportive data for FDA's evaluation. In April, the company announced the closing of a registered direct offering of up to $7.1 million, issuing 825,085 shares of our common stock or pre-funded warrants at a purchase price of $3.03 per share, 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 1.65 million 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 24 months following the effective date of the registration statement, registering resale of the shares of common stock underlying the short-term warrants.

Speaker #5: This will elevate the product profile of Ibez, as well as provide significant supporting data for the FDA's evaluation. In April, the company announced the closing of a registered direct offering of up to $7.1 million, issuing 825,085 shares of our common stock, or pre-funded warrants, at a purchase price of $3.03 per share.

Speaker #5: 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 1.65 million shares of common stock.

Speaker #5: The short-term warrants have an exercise price of $2.78 per share and are immediately exercisable upon issuance. They will expire 24 months following the effective date of their registration statement, which registers the resale of the shares of common stock underlying the short-term warrants.

Speaker #5: This additional funding, when coupled with the remaining availability under our equity line of credit, ensures that the company has the financial resources to conduct the Pathfinder clinical trial.

David P. Luci: 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 PATHFINDER clinical trial in recurrent CDI and fund operations for at least one year. Also in April, a scientific poster showing that our new DNA Pol IIIC systemically absorbed antibiotics in preclinical development to treat other Gram-positive infections achieved potentially therapeutic plasma levels and reduced MRSA tissue burden while maintaining a higher gut microbial diversity similar to baseline and distinct from linezolid. These data were presented at the 35th Congress of European Society for Paediatric Infectious Diseases, held in Munich, Germany.

David Luci: 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 PATHFINDER clinical trial in recurrent CDI and fund operations for at least one year. Also in April, a scientific poster showing that our new DNA Pol IIIC systemically absorbed antibiotics in preclinical development to treat other Gram-positive infections achieved potentially therapeutic plasma levels and reduced MRSA tissue burden while maintaining a higher gut microbial diversity similar to baseline and distinct from linezolid. These data were presented at the 35th Congress of European Society for Paediatric Infectious Diseases, held in Munich, Germany.

Speaker #5: In recurrent C. diff. and fund operations for at least one year. Also, in April, a scientific poster showed that our new DNA POL3C systemically absorbed antibiotics in pre-clinical development to treat other gram-positive infections achieved potentially therapeutic plasma levels and reduced MRSA tissue burden, while maintaining a higher gut microbial diversity similar to baseline and distinct from linezolid.

Speaker #5: These data were presented at the 35th Congress of Excellence held in Munich, Germany. Dr. Khurshidi Begum, a research scientist in the laboratory of Dr. Kevin Gary at the University of Houston, presented the poster entitled "Pre-clinical Microbiome Evaluation of Novel POLC Inhibitor Compounds."

David P. Luci: Dr. Khurshida Begum, research scientist in the laboratory of Dr. Kevin Garey at University of Houston, presented the poster entitled "Preclinical Microbiome Evaluation of Novel PolC Inhibitor Compounds." Using microbiome profiling metagenomics, the authors concluded that DNA Pol IIIC antibiotic compounds represent a targeted strategy to treat resistant Gram-positive infections while preserving microbiome structure, minimizing downstream complications associated with antibiotic-induced dysbiosis. Commenting on the significance of this data, Dr. Garey from the University of Houston stated, "Discovering highly selective antibacterial agents that specifically target systemic bacterial pathogens while avoiding the eradication of trillions of health-promoting bacteria in our gut microbiome is the, quote-unquote, 'holy grail of antibiotic development.' Initial work at the University of Houston with Acurx novel Pol IIIC inhibitors has demonstrated favorable gut microbiome-sparing effects.

David Luci: Dr. Khurshida Begum, research scientist in the laboratory of Dr. Kevin Garey at University of Houston, presented the poster entitled "Preclinical Microbiome Evaluation of Novel PolC Inhibitor Compounds." Using microbiome profiling metagenomics, the authors concluded that DNA Pol IIIC antibiotic compounds represent a targeted strategy to treat resistant Gram-positive infections while preserving microbiome structure, minimizing downstream complications associated with antibiotic-induced dysbiosis. Commenting on the significance of this data, Dr. Garey from the University of Houston stated, "Discovering highly selective antibacterial agents that specifically target systemic bacterial pathogens while avoiding the eradication of trillions of health-promoting bacteria in our gut microbiome is the, quote-unquote, 'holy grail of antibiotic development.' Initial work at the University of Houston with Acurx novel Pol IIIC inhibitors has demonstrated favorable gut microbiome-sparing effects.

Speaker #5: Using microbiome profiling and metagenomics, the authors concluded that DNA POL3C antibiotic compounds represent a targeted strategy to treat resistant gram-positive infections while preserving microbiome structure, minimizing downstream complications associated with antibiotic-induced dysbiosis.

Speaker #5: Commenting on the significance of this data, Dr. Gary from the University of Houston stated, "Discovering highly selective antibacterial agents that specifically target systemic bacterial pathogens while avoiding the eradication of trillions of health-promoting bacteria in our gut microbiome is the 'holy grail' of antibiotic development." Initial work at the University of Houston with Acurx's novel POL3C inhibitors has demonstrated favorable gut microbiome-sparing effects.

Speaker #5: The novel findings presented at Excellence demonstrate these positive microbiome results to be a class effect of DNA POL3C inhibitors, potentially positioning them as unique additions to the anti-gram-positive therapeutic armamentarium.

David P. Luci: The novel findings presented at European Society for Paediatric Infectious Diseases demonstrate these positive microbiome results to be a class effect of DNA Pol IIIC inhibitors, potentially positioning them as unique additions to the anti-Gram-positive therapeutic armamentarium." This work, coupled with our recently announced scientific partnership with Leiden University Medical Center, will pave the way for further rational design of novel DNA Pol IIIC inhibitors to expand our opportunities for lead optimization in our portfolio of groundbreaking anti-infective therapeutics. With regard to our patent estate, to date, Acurx has secured six US patents and an additional 10 patents internationally, including Australia, Canada, Europe, Israel, India, Japan, Korea, and Mexico, all of which protect key aspects of our company's ibezapolstat and the ACX-375C program targeting DNA Pol IIIC. Additional country-level patent applications remain under review.

David Luci: The novel findings presented at European Society for Paediatric Infectious Diseases demonstrate these positive microbiome results to be a class effect of DNA Pol IIIC inhibitors, potentially positioning them as unique additions to the anti-Gram-positive therapeutic armamentarium." This work, coupled with our recently announced scientific partnership with Leiden University Medical Center, will pave the way for further rational design of novel DNA Pol IIIC inhibitors to expand our opportunities for lead optimization in our portfolio of groundbreaking anti-infective therapeutics. With regard to our patent estate, to date, Acurx has secured six US patents and an additional 10 patents internationally, including Australia, Canada, Europe, Israel, India, Japan, Korea, and Mexico, all of which protect key aspects of our company's ibezapolstat and the ACX-375C program targeting DNA Pol IIIC. Additional country-level patent applications remain under review.

Speaker #5: So this work, coupled with our recently announced scientific partnership with Leiden University Medical Center, will pave the way for further rational design of novel DNA POL3C inhibitors to expand our opportunities for lead optimization in our portfolio of groundbreaking anti-infective therapeutics.

Speaker #5: With regard to our patent estate, to date Acurx has secured six U.S. patents and an additional ten patents internationally, including in Australia, Canada, Europe, Israel, India, Japan, Korea, and Mexico.

Speaker #5: All of which protect key aspects of our company's ibezoprostat and the ACX375C program targeting DNA POL3C. Additional country-level patent applications remain under review. Also, and significantly, in the first quarter, a new patent was issued relating to ibezoprostat and its use to treat CDI while reducing the recurrence of the infection.

David P. Luci: Also, significantly, in the first quarter, a new patent was issued relating to ibezapolstat 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. We continue to identify and pursue funding opportunities for our phase III IBZ-ASPIRE trial for the treatment of both acute CDI and a reduction of recurrence. We have several initiatives underway to this end, and we will report our progress in future updates. As we have continually reported, ibezapolstat clinical and non-clinical results continue to outperform in a serious and potentially life-threatening infectious disease caused by C. difficile bacteria that the CDC categorizes as an urgent threat and calls for new classes of antibiotics for initial treatment that also have a low incidence of recurrence.

David Luci: Also, significantly, in the first quarter, a new patent was issued relating to ibezapolstat 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. We continue to identify and pursue funding opportunities for our phase III IBZ-ASPIRE trial for the treatment of both acute CDI and a reduction of recurrence. We have several initiatives underway to this end, and we will report our progress in future updates. As we have continually reported, ibezapolstat clinical and non-clinical results continue to outperform in a serious and potentially life-threatening infectious disease caused by C. difficile bacteria that the CDC categorizes as an urgent threat and calls for new classes of antibiotics for initial treatment that also have a low incidence of recurrence.

Speaker #5: As well as improving the health of the gut microbiome. Additional country-level patent applications remain under review. We continue to identify and pursue funding opportunities for our Phase 3 Aspire trial.

Speaker #5: For the treatment of both acute CDI and the reduction of recurrence, we have several initiatives underway to this end and will report our progress in future updates.

Speaker #5: As we've continually reported, Ibez clinical and non-clinical results continue to outperform in a serious and potentially life-threatening infectious disease caused by C. difficile bacteria—a condition that the CDC categorizes as an urgent threat and for which they call for new classes of antibiotics for initial treatment that also have a low incidence of recurrence.

Speaker #5: Furthermore, Ibez has FDA QIDP and Fast Track designations for treatment of CDI, as well as SME, or Small and Medium Enterprise, status in the EU.

David P. Luci: Furthermore, ibezapolstat has FDA QIDP and Fast Track designations for treatment of CDI, as well as SME or small and medium enterprise status in the EU. All Acurx compounds in preclinical development are FDA and Fast Track eligible, not received yet, and target positive infectious disease classified as serious threat priorities by CDC and FDA. We remain confident that while development of ibezapolstat's competitive profile continues to evolve and strengthen, we will continue to successfully navigate through these challenging times in our industry sector. Now back over to Rob Shawah, our CFO, to guide you through the highlights of our financial results for Q2 2026. Rob?

David Luci: Furthermore, ibezapolstat has FDA QIDP and Fast Track designations for treatment of CDI, as well as SME or small and medium enterprise status in the EU. All Acurx compounds in preclinical development are FDA and Fast Track eligible, not received yet, and target positive infectious disease classified as serious threat priorities by CDC and FDA. We remain confident that while development of ibezapolstat's competitive profile continues to evolve and strengthen, we will continue to successfully navigate through these challenging times in our industry sector. Now back over to Rob Shawah, our CFO, to guide you through the highlights of our financial results for Q2 2026. Rob?

Speaker #5: All Acurx compounds and pre-clinical development are FDA and Fast Track eligible—not received yet—and target positive infectious diseases classified as serious threat priorities by the CDC and FDA.

Speaker #5: We remain confident that, while development of Ibez's competitive profile continues to evolve and strengthen, we'll continue to successfully navigate through these challenging times in our industry sector.

Speaker #5: And now, back over to Rob Shawah, our CFO, to guide you through the highlights of our financial results for the second quarter of 2026.

Speaker #5: Rob?

Speaker #2: Thanks, Dave. Our financial results for the second quarter, ended June 30, 2026, were included in our press release issued earlier this morning. The company ended the quarter with cash totaling $10.7 million.

Rob G. Shawah: Thanks, Dave. Our financial results for Q2 ended 30 June 2026 were included in our press release issued earlier this morning. The company ended the quarter with cash totaling $10.7 million, compared to $7.6 million as of 31 December 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. Research and development expenses for the three months ended 30 June 2026 were $1.1 million, compared to $0.5 million for the three months ended 30 June 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.

Rob Shawah: Thanks, Dave. Our financial results for Q2 ended 30 June 2026 were included in our press release issued earlier this morning. The company ended the quarter with cash totaling $10.7 million, compared to $7.6 million as of 31 December 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. Research and development expenses for the three months ended 30 June 2026 were $1.1 million, compared to $0.5 million for the three months ended 30 June 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.

Speaker #2: 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 point million dollars point eight million dollars under the equity line of credit.

Speaker #2: 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.

Speaker #2: 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.

Speaker #2: For the six months ended June 30, research and development expenses were $1.4 million, compared to $1.1 million for the six months ended June 30, 2025.

Rob G. Shawah: For the six months ended 30 June, research and development expenses are $1.4 million, compared to $1.1 million for the six months ended 30 June 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. General and administrative expenses for the three months ended 30 June were $1.2 million, compared to $1.7 million for the three months ended 30 June 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 30 June, general and administrative expenses were $2.6 million.

Rob Shawah: For the six months ended 30 June, research and development expenses are $1.4 million, compared to $1.1 million for the six months ended 30 June 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. General and administrative expenses for the three months ended 30 June were $1.2 million, compared to $1.7 million for the three months ended 30 June 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 30 June, general and administrative expenses were $2.6 million.

Speaker #2: The point three million dollar increase was due primarily to a point million dollar point one million dollar increase in consulting fees and a point two million dollar increase in manufacturing costs as a result of costs associated with the new recurrent CDI trial program.

Speaker #2: General and administrative expenses for the three months ended June 30 were $1.2 million, compared to $1.7 million for the three months ended June 30, 2025.

Speaker #2: A decrease of point five million dollars. The decrease was primarily due to a point three million dollar decrease in professional fees of point one million dollar decrease in legal costs and a point one million dollar decrease in share-based compensation expense.

Speaker #2: For the six months ended June 30th, general and administrative expenses were $2.6 million. That was compared to $3.3 million for the six months ended June 30th, 2025.

Rob G. Shawah: That was compared to $3.3 million for the six months ended 30 June 2025, a decrease of $0.7 million. The decrease was due primarily to a $0.3 million decrease in professional fees, a $0.2 million decrease in legal costs, and a $0.2 million decrease in share-based compensation expense. The company reported a net loss of $2.3 million, or $0.53 per diluted share for the three months ended 30 June 2026. That was compared to a net loss of $2.2 million, or $1.89 per diluted share for the three months ended 30 June 2025. For the six months ended 30 June, the company reported a net loss of $3.9 million, or $1.13 per diluted share. That was compared to a net loss of $4.4 million or $4.01 per diluted share for the six months ended 30 June 2025, all for the reasons previously mentioned.

Rob Shawah: That was compared to $3.3 million for the six months ended 30 June 2025, a decrease of $0.7 million. The decrease was due primarily to a $0.3 million decrease in professional fees, a $0.2 million decrease in legal costs, and a $0.2 million decrease in share-based compensation expense. The company reported a net loss of $2.3 million, or $0.53 per diluted share for the three months ended 30 June 2026. That was compared to a net loss of $2.2 million, or $1.89 per diluted share for the three months ended 30 June 2025. For the six months ended 30 June, the company reported a net loss of $3.9 million, or $1.13 per diluted share. That was compared to a net loss of $4.4 million or $4.01 per diluted share for the six months ended 30 June 2025, all for the reasons previously mentioned.

Speaker #2: A decrease of point seven million. The decrease was due primarily to a point three million dollar decrease in professional fees of point two million dollar decrease in legal costs and a point two million dollar decrease in share-based compensation expense.

Speaker #2: The company reported a net loss of $2.3 million, or $0.53 per diluted share, for the three months ended June 30, 2026. That compares to a net loss of $2.2 million, or $1.89 per diluted share, for the three months ended June 30, 2025.

Speaker #2: For the six months ended June 30th, the company reported a net loss of $3.9 million, or $1.13 per diluted share, compared to a net loss of $4.4 million, or $4.01 per diluted share, for the six months ended June 30th, 2025.

Speaker #2: All for the reasons previously mentioned. The company had 4,683,253 shares outstanding as of June 30, 2026. With that, I'll turn the call back over to Dave.

Rob G. Shawah: The company had 4,683,253 shares outstanding as of 30 June 2026. With that, I'll turn the call back over to Dave.

Rob Shawah: The company had 4,683,253 shares outstanding as of 30 June 2026. With that, I'll turn the call back over to Dave.

Speaker #3: Thanks, Rob, and thank you all for joining us today. Before bringing our operator back to open the call for questions, I'm pleased to welcome to the call our Medical Director, Dr. Michael Silverman, and our Executive Chairman, Bob DeLucia, to assist with Q&A regarding our recent FDA meeting and our ibezifosat clinical development program.

David P. Luci: Thanks, Rob, and to all of you for joining us today. Before bringing our operator back to open the call for questions, I'm pleased to welcome to the call our Medical Director, Dr. Michael Silverman, and our Executive Chairman, Bob DeLuccia, to assist with Q&A regarding our recent FDA meeting and our ibezapolstat clinical development program. Now back to the operator to open the call for questions. Operator?

David Luci: Thanks, Rob, and to all of you for joining us today. Before bringing our operator back to open the call for questions, I'm pleased to welcome to the call our Medical Director, Dr. Michael Silverman, and our Executive Chairman, Bob DeLuccia, to assist with Q&A regarding our recent FDA meeting and our ibezapolstat clinical development program. Now back to the operator to open the call for questions. Operator?

Speaker #3: And now, back to the operator to open the call for questions. Operator?

Speaker #4: Thank you. We'll now be conducting our question-and-answer session. If you'd like to ask a question at this time, you may press star one from your telephone keypad, and a confirmation tone will indicate your line is in the question queue.

Operator: Thank you. We'll now be conducting our question and answer session. If you'd like to ask a question at this time, you may press star one from your telephone keypad and a confirmation tone will indicate your line in the question queue. You may press star two if you'd like to remove your question from the queue. For participants using speaker equipment, it may be necessary to pick up your handset before pressing the star keys. Thank you, and our first question is from the line of Radhika Chiripali with S&P. Please proceed with your question. Radhika, your line is open for a question. It seems like we've lost connection with Radhika. We'll move on to our next question, will be from Matthew Keller of H.C. Wainwright. Please proceed with your question.

Operator: Thank you. We'll now be conducting our question and answer session. If you'd like to ask a question at this time, you may press star one from your telephone keypad and a confirmation tone will indicate your line in the question queue. You may press star two if you'd like to remove your question from the queue. For participants using speaker equipment, it may be necessary to pick up your handset before pressing the star keys. Thank you, and our first question is from the line of Radhika Chiripali with S&P. Please proceed with your question. Radhika, your line is open for a question. It seems like we've lost connection with Radhika. We'll move on to our next question, will be from Matthew Keller of H.C. Wainwright. Please proceed with your question.

Speaker #4: You may press star two if you'd like to remove your question from the queue. For participants using speaker equipment, it may be necessary to pick up your handset before pressing the star keys.

Speaker #4: Thank you. Our first question is from the line of Radhika Cherupalli with S&P. Please proceed with your question. Radhika, your line is open.

Speaker #4: It seems like we've lost connection with Radhika. We'll move on to our next question, which will be from Matthew Keller of H.C. Wainwright. Please proceed with your questions.

Speaker #5: Hey, good morning. Thanks for taking my questions. So, my first one is related to manufacturing. I was wondering, do you have enough API for the planned upcoming trials?

Matthew Keller: Hey, good morning. Thanks for taking our questions. My first one related to manufacturing. I was wondering, do you have enough API for the planned upcoming trials? I guess, where do you stand, or where do you stand potentially on manufacturing ibezapolstat?

Matthew Keller: Hey, good morning. Thanks for taking our questions. My first one related to manufacturing. I was wondering, do you have enough API for the planned upcoming trials? I guess, where do you stand, or where do you stand potentially on manufacturing ibezapolstat?

Speaker #5: And I guess, where do you stand, or where could you potentially stand, on manufacturing Ibezifosat?

Speaker #3: Thank you, Matt. Bob, would you like to?

David P. Luci: Thank you, Matt. Bob, would you like to

David Luci: Thank you, Matt. Bob, would you like to

Speaker #6: Yeah, if I can understand the question, where do we stand on—we have plenty of API, and also the formulated product is all ready to go to support the Pathfinder trial.

Robert J. DeLuccia: Yeah, if I may just answer the question, where do we stand on that? We have plenty of API, and also the formulated product is all ready to go to support the IBZ-PATHFINDER trial, and we're poised to have enough API manufacturing with appropriate dating to start the IBZ-ASPIRE trial as well.

Bob DeLuccia: Yeah, if I may just answer the question, where do we stand on that? We have plenty of API, and also the formulated product is all ready to go to support the IBZ-PATHFINDER trial, and we're poised to have enough API manufacturing with appropriate dating to start the IBZ-ASPIRE trial as well.

Speaker #6: And we're poised to have enough API manufactured, with appropriate dating, to start the Ibezifosat Aspire trial as well.

Speaker #5: Perfect. And then a second question, if I may. Oh—oh, go ahead. Sorry.

Matthew Keller: Perfect. A second question, if I may. Oh, go ahead. Sorry.

Matthew Keller: Perfect. A second question, if I may. Oh, go ahead. Sorry.

Speaker #6: Yes. I just want to make sure that answered your question.

Robert J. DeLuccia: Yep. I want to make sure that answered your question.

Bob DeLuccia: Yep. I want to make sure that answered your question.

Speaker #5: Oh, yeah, yeah. And the second question, I guess, if I may. Again, you guided that the Aspire trial will be an international trial. I was wondering what geographies you guys are considering and if you've begun startup activities in those regions for that trial.

Matthew Keller: Oh, yeah. The second question is, if I may, again, you have guided that the IBZ-ASPIRE trial will be an international trial. I was wondering what geographies you guys are considering, and if you have begun activities in those regions for that trial.

Matthew Keller: Oh, yeah. The second question is, if I may, again, you have guided that the IBZ-ASPIRE trial will be an international trial. I was wondering what geographies you guys are considering, and if you have begun activities in those regions for that trial.

Speaker #6: Yes, I can answer that as well. Mike, are you on the line? You can join in just to give an idea of the scope of the trial internationally.

Robert J. DeLuccia: Yep. I can answer that as well. Mike, are you on the line? You can join in, just to give an idea of the scope of the trial internationally.

Bob DeLuccia: Yep. I can answer that as well. Mike, are you on the line? You can join in, just to give an idea of the scope of the trial internationally.

Speaker #1: Well, the plans are international. I don't have my finger on the pulse of every country that we've considered, but certainly Western and Eastern Europe.

Michael Silverman: Well, the plans are international. I do not have my finger on the pulse of every country that we have considered, but certainly Western and Eastern Europe. I do not know. Bob, please expand if you can.

Michael Silverman: Well, the plans are international. I do not have my finger on the pulse of every country that we have considered, but certainly Western and Eastern Europe. I do not know. Bob, please expand if you can.

Speaker #1: I don't know. Bob, please expand if you can.

Speaker #6: Yeah. If you need, we can follow up with the details of the countries, but we haven't begun screening for that yet. But it will be all-inclusive of those countries that we know have generally high incidence of C.

Robert J. DeLuccia: Yeah. We can follow up with the details of the countries, but we haven't begun screening for that yet. But it will be all-inclusive of those countries that we know have generally high incidence of C. difficile infection, obviously.

Bob DeLuccia: Yeah. We can follow up with the details of the countries, but we haven't begun screening for that yet. But it will be all-inclusive of those countries that we know have generally high incidence of C. difficile infection, obviously.

Speaker #6: difficile infection, obviously.

Speaker #5: Yep, no, makes sense. Thank you very much, guys.

Matthew Keller: Yep. No, makes sense. Thank you very much, guys.

Matthew Keller: Yep. No, makes sense. Thank you very much, guys.

Speaker #3: Thank you.

Robert J. DeLuccia: Thank you.

Bob DeLuccia: Thank you.

Speaker #4: As a reminder, to ask a question, you may press star one. Our next questions are from the line of James Molloy of Lions Global Partners.

Operator: As a reminder, to ask a question, you may press star one. Our next questions are from the line of James Malloy with Alliance Global Partners. Please proceed with your questions.

Operator: As a reminder, to ask a question, you may press star one. Our next questions are from the line of James Malloy with Alliance Global Partners. Please proceed with your questions.

Speaker #4: Please proceed with your questions.

Speaker #3: Good morning, James.

Robert J. DeLuccia: Good morning, James.

Bob DeLuccia: Good morning, James.

Speaker #7: Good morning. Thank you very much for taking my question. One of the things you guys highlighted on August 3rd—you touched on this—is that the FDA has indicated that if the data is robust enough, it may give you induction as well as maintenance of remission.

James Malloy: Good morning. Thank you very much for taking my question. One of the things you guys highlighted on 3 August, you touched on the FDA, if the data is robust enough, may give you induction as well as a maintenance of remission. Can you walk through what constitutes a reduction of remission? What constitutes robust enough data? I know the FDA won't guide to that exactly, but in your mind, what gives you guys coming out of the IBZ-PATHFINDER trial and going into IBEZ-ASPIRE, what's your target? You can talk about some of the FDA's interactions regarding that, please.

James Molloy: Good morning. Thank you very much for taking my question. One of the things you guys highlighted on 3 August, you touched on the FDA, if the data is robust enough, may give you induction as well as a maintenance of remission. Can you walk through what constitutes a reduction of remission? What constitutes robust enough data? I know the FDA won't guide to that exactly, but in your mind, what gives you guys coming out of the IBZ-PATHFINDER trial and going into IBEZ-ASPIRE, what's your target? You can talk about some of the FDA's interactions regarding that, please.

Speaker #7: Is can you walk through sort of what constitutes a reduction of remission? What constitutes sort of robust enough data? I know the FDA won't guide to that exactly, but in your mind, what gives you guys coming out of the pathfinder trial and going into Aspire, what do you sort of what's your target to and you can talk about sort of the FDA's interactions regarding that, please.

Speaker #6: Yeah, this is Bob. This is Bob. I'll let Mike join in. At the meeting, we laid out the parameters as to what would constitute robust.

Robert J. DeLuccia: Yeah. This is Bob. I'll let Mike join in. At the meeting, we laid out the parameters as to what would constitute robust, and Mike, you want to go over those?

Bob DeLuccia: Yeah. This is Bob. I'll let Mike join in. At the meeting, we laid out the parameters as to what would constitute robust, and Mike, you want to go over those?

Speaker #6: And Mike, do you want to go over those?

Speaker #1: Yeah, thanks for the question. As you say, it's not something that can be specifically prescribed. But as Bob said, we proposed a number of potential criteria based on good clinical practices and also various FDA guidances.

Michael Silverman: Yeah. Thanks for the question. As you say, it's not something that can be specifically prescribed. As Bob said, we proposed a number of potential criteria based on good clinical practices and also various FDA guidances. I like to think about the support of the robustness in two general categories. One are those items that we would naturally build into a clinical trial, good clinical practice, high-quality data, minimization of protocol violations, minimization of missing data, those sorts of things to ensure that the data are trustworthy. The second bucket of activities, your second bucket of criteria, would be those things that are inherent in the drug. Consistency of efficacy data across all of our endpoints, across all of our trial sites, across all of our countries, and I think this gets back to the previous question.

Michael Silverman: Yeah. Thanks for the question. As you say, it's not something that can be specifically prescribed. As Bob said, we proposed a number of potential criteria based on good clinical practices and also various FDA guidances. I like to think about the support of the robustness in two general categories. One are those items that we would naturally build into a clinical trial, good clinical practice, high-quality data, minimization of protocol violations, minimization of missing data, those sorts of things to ensure that the data are trustworthy. The second bucket of activities, your second bucket of criteria, would be those things that are inherent in the drug. Consistency of efficacy data across all of our endpoints, across all of our trial sites, across all of our countries, and I think this gets back to the previous question.

Speaker #1: I like to think about the support of robustness in two general categories. One is these items that we would naturally build into a clinical trial: good clinical practice.

Speaker #1: High-quality data, minimization of protocol violations, minimization of missing data—those sorts of things to ensure that the data are trustworthy. The second bucket of activities, your second bucket of criteria, would be those things that are inherent in the drug.

Speaker #1: Consistency of efficacy data across all of our endpoints, across all of our trial sites, across all of our countries. And I think this gets back to the previous question—we also need to ensure that our patient population is representative of the kinds of patients we would see in the United States.

Michael Silverman: We also need to ensure that our patient population is representative of the kinds of patients we would see in the United States, so we do an international trial. We have to have an eye on clinical practice and clinical guidelines that are applicable in the United States. Those are the sorts of things that we're building into this trial. I hope that helps.

Michael Silverman: We also need to ensure that our patient population is representative of the kinds of patients we would see in the United States, so we do an international trial. We have to have an eye on clinical practice and clinical guidelines that are applicable in the United States. Those are the sorts of things that we're building into this trial. I hope that helps.

Speaker #1: So if we do an international trial, we have to keep an eye on clinical practice and clinical guidelines that are applicable in the United States.

Speaker #1: Those are the sorts of things that we're building into this trial. I hope that helps.

Speaker #3: Yeah, you know, just to build on that a little bit—thank you, Mike—and Bob, one of the features of this new Aspire trial design is to measure the patients for an extraordinary amount of time after the end of treatment: eight weeks after the end of treatment, which we don't know has been done before.

David P. Luci: Yeah. Just to build on that a little bit. Thank you, Mike and Bob. One of the features of this new ASPIRE trial design is to measure the patients an extraordinary amount of time after the end of treatment, 8 weeks after the end of treatment, which we don't know that that's been done before, but I think that also speaks to the robustness of the data. If you're seeing no reinfection 8 weeks after the end of treatment in a patient population that's had three or more prior episodes in the past year, we think the FDA will find that to be persuasive.

David Luci: Yeah. Just to build on that a little bit. Thank you, Mike and Bob. One of the features of this new ASPIRE trial design is to measure the patients an extraordinary amount of time after the end of treatment, 8 weeks after the end of treatment, which we don't know that that's been done before, but I think that also speaks to the robustness of the data. If you're seeing no reinfection 8 weeks after the end of treatment in a patient population that's had three or more prior episodes in the past year, we think the FDA will find that to be persuasive.

Speaker #3: But I think that also speaks to the robustness of the data. So, if you're seeing no reinfection eight weeks after the end of treatment in a patient population that's had three or more prior episodes in the past year, we think the FDA will find that to be persuasive.

Speaker #7: And I guess—yeah—what's sort of the bogey with Vanco that you're trying to beat? Assuming you do have some, of course, but how much better than Vanco do you think the FDA will say, "Hey, that's robust?"

James Malloy: I guess, yeah. What's sort of the bogey with vancomycin that you're trying to beat, assuming you do have some, of course, but how much better than vancomycin do you think the FDA will say that's robust?

James Molloy: I guess, yeah. What's sort of the bogey with vancomycin that you're trying to beat, assuming you do have some, of course, but how much better than vancomycin do you think the FDA will say that's robust?

Speaker #1: Yeah. In terms of—that’s another good point, which is the significance of the results. This is not a superiority trial; this is a non-inferiority trial.

Michael Silverman: Yeah. It's another good point, which is the statistical significance of the results. This is not a superiority trial. This is a non-inferiority trial. We don't have to show superiority over vancomycin for the critical care acute treatment endpoint. We need to show non-inferiority within standard bounds, which is a statistical concept. But the lower limit would be a confidence interval within 10%. That's a non-inferiority approach.

Michael Silverman: Yeah. It's another good point, which is the statistical significance of the results. This is not a superiority trial. This is a non-inferiority trial. We don't have to show superiority over vancomycin for the critical care acute treatment endpoint. We need to show non-inferiority within standard bounds, which is a statistical concept. But the lower limit would be a confidence interval within 10%. That's a non-inferiority approach.

Speaker #1: So, we don't have to show superiority over Vancomycin for the clinical care acute treatment endpoint. We need to show non-inferiority within standard bounds, which is a statistical concept, but the lower limit would be the confidence interval within 10%.

Speaker #1: That's a non-inferiority approach.

Speaker #7: And actually, and then maybe a final question from me. I know that the Pathfinders—first, I think you've guided to maybe a year and a half to enroll.

James Malloy: Excellent. And then maybe the final question from me would be, I know that the Pathfinder's first, I think you've guided to maybe a year and a half to enroll. Before you go to the IBZ-ASPIRE trial, certainly the final potentially pivotal trial, how important is the Pathfinder data for a potential partnership to help fund the phase III IBZ-ASPIRE trial down the road?

James Molloy: Excellent. And then maybe the final question from me would be, I know that the Pathfinder's first, I think you've guided to maybe a year and a half to enroll. Before you go to the IBZ-ASPIRE trial, certainly the final potentially pivotal trial, how important is the Pathfinder data for a potential partnership to help fund the phase III IBZ-ASPIRE trial down the road?

Speaker #7: How much is—and before you go to the Aspire trial, certainly the final, potentially pivotal trial—how important is the Pathfinder data for a potential partnership to help fund the Phase 3 Aspire trial down the road?

David P. Luci: We think that's quite important, and we're heartened by the FDA's enthusiasm with our being willing to conduct that trial. Now, interestingly, whether or not the IBZ-ASPIRE trial is eventually funded, there's a second pathway to FDA approval under the LPAD pathway for recurrent C. diff. So if we finish the 20-patient exploratory trial, open label, that we call Pathfinder, we will meet with the FDA, and we have the possibility to be considered an LPAD pathway program, which would give us the ability to file for approval in recurrent C. diff with just one phase III trial, which may be somewhere in the neighborhood of half the price of one of the IBZ-ASPIRE trials.

David Luci: We think that's quite important, and we're heartened by the FDA's enthusiasm with our being willing to conduct that trial. Now, interestingly, whether or not the IBZ-ASPIRE trial is eventually funded, there's a second pathway to FDA approval under the LPAD pathway for recurrent C. diff. So if we finish the 20-patient exploratory trial, open label, that we call Pathfinder, we will meet with the FDA, and we have the possibility to be considered an LPAD pathway program, which would give us the ability to file for approval in recurrent C. diff with just one phase III trial, which may be somewhere in the neighborhood of half the price of one of the IBZ-ASPIRE trials.

Speaker #3: We think that's quite important, and we're heartened by the FDA's enthusiasm with our being willing to conduct that trial. Now, interestingly, whether or not the Aspire trial is eventually funded, there's a second pathway to FDA approval under the LPAD pathway for recurrent C.

Speaker #3: diff. So if we finish the 20-patient exploratory trial open label that we call pathfinder, we will meet with the FDA and we have the possibility to be considered an LPAD pathway program, which would make the which would make us give us the ability to file for approval in recurrent C.

Speaker #3: ...with just one Phase 3 trial, which may be somewhere in the neighborhood of half the price of one of the Aspire trials.

Speaker #6: Yeah, I agree with you, Dave. That's important—very important.

Robert J. DeLuccia: Yeah, I agree with you there. That's important. Very important.

Bob DeLuccia: Yeah, I agree with you there. That's important. Very important.

Speaker #7: Okay, that's all my questions. Thank you very much.

James Malloy: Okay, that's all my questions. Thank you very much.

James Molloy: Okay, that's all my questions. Thank you very much.

Speaker #3: Thank you, James.

David P. Luci: Thank you, James.

David Luci: Thank you, James.

Speaker #2: Thank you. This now concludes our question-and-answer session. And, ladies and gentlemen, this will also conclude today's conference. We thank you for your participation. Have a wonderful day.

Operator: Thank you. This now concludes our question and answer session. Ladies and gentlemen, this also concludes today's conference. We thank you for your participation. Have a wonderful day.

Operator: Thank you. This now concludes our question and answer session. Ladies and gentlemen, this also concludes today's conference. We thank you for your participation. Have a wonderful day.

Speaker #3: Thank you, Rob.

David P. Luci: Thank you, Rob.

David Luci: Thank you, Rob.

Robert J. DeLuccia: Thank you.

Bob DeLuccia: Thank you.

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Q2 2026 Acurx Pharmaceuticals Inc Earnings Call

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Acurx Pharmaceut

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Q2 2026 Acurx Pharmaceuticals Inc Earnings Call

ACXP

Friday, August 14th, 2026 at 12:00 PM

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