Q4 2025 Acurx Pharmaceuticals Inc Earnings Call

March 13, 2026

Operator: Greetings, and welcome to Acurx Pharmaceuticals Conference Call to Discuss Full Year and Q4 2025 Financial Results. At this time, all participants are on a listen-only mode. A question and answer session will follow the formal presentation. If anyone requires operator assistance during the conference, please press star zero on your telephone keypad. As a reminder, this conference is being recorded. It is now my pleasure to introduce your host, Rob Shawah, Chief Financial Officer. Thank you. Please go ahead.

Speaker #2: A question-and-answer session will follow the formal presentation. If anyone requires operator assistance during the conference, please press star zero on your telephone keypad.

Speaker #2: As a reminder, this conference is being recorded. It is now my pleasure to introduce your host, Rob Shawah, Chief Financial Officer. Thank you. Please go ahead.

Speaker #2: Thank you, Donna. Good morning, and welcome to our call. This morning, we issued a press release providing financial results and company highlights for the year ended and fourth quarter 2025, which is available on our website at acurxpharma.com.

Robert G. Shawah: Thank you, Donna. Good morning and welcome to our call. This morning we issued a press release providing financial results and company highlights for the year and Q4 2025, which is available on our website at acurxpharma.com. Joining me today are Bob DeLucia, Executive Chairman of Acurx, Dr. Michael Silverman, Medical Director of Acurx, who will be available for questions related to our R&D activities and strategy during the Q&A period, and Dave Lucci, President and CEO of Acurx, who will start by providing a corporate update and outlook. Following that, I'll provide some highlights to the financials from the year and Q4 ended December 31, 2025, and then turn the call back over to Dave for his closing remarks.

Speaker #2: Joining me today are Bob DeLucia, Executive Chairman of Acurx; Dr. Michael Silverman, Medical Director of Acurx, who will be available for questions related to our R&D activities and strategy during the Q&A period; and David Luci, President and CEO of Acurx.

Speaker #2: We'll start by providing a corporate update and outlook. Following that, I'll provide some highlights of the financials from the year and fourth quarter ended December 31, 2025, and then turn the call back over to Dave for his closing remarks.

Speaker #2: 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.

Robert G. Shawah: 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. Investors should consider these risks and other information described in our filings with the Securities and Exchange Commission, including our annual report on Form 10-K, which we filed yesterday, Thursday, 12 March 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's accurate only as of the date of this live broadcast, today, 13 March 2026. I'll now turn the call over to David P. Luci. David P. Luci?

Speaker #2: Investors should consider these risks and other information described in our filings with the Securities and Exchange Commission, including our annual report on Form 10-K, which we filed yesterday, Thursday, March 12, 2026.

Speaker #2: 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 #2: This conference call contains time-sensitive information that's accurate only as of the date of this live broadcast—today, March 13, 2026. I'll now turn the call over to David Luci.

Speaker #2: Dave?

Speaker #3: Thanks, Rob. Good morning, everyone, and thank you so much for joining us to review our financial results for the fourth quarter and year ended December 31, 2025, and also to hear some recent updates which we're excited about.

David P. Luci: Thanks, Rob. Good morning, everyone, and thank you so much for joining us to review our financial results for the Q4 and year ended December 31, 2025, and also to hear some recent updates, which we're excited about. We'd be pleased to take any questions. First, I'd like to briefly summarize just a few of our key activities for the Q4 of 2025, or in some cases, shortly thereafter. First, in October, the company received gross proceeds from the execution of 170,000 Series F warrants of approximately $1.4 million. Also in October, 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, who's with us this morning, and Dr.

Speaker #3: Then we'd be pleased to take any questions. First, I'd like to briefly summarize just a few of our key activities for the fourth quarter of '25, or in some cases, shortly thereafter.

Speaker #3: First, in October, the company received gross proceeds from the execution of 170,000 Series F warrants of approximately $1.4 million. Also in October, we were one of five companies to make a formal presentation at ID Week in Atlanta, at the session entitled 'New Antimicrobials in the Pipeline.'

Speaker #3: Presenting on behalf of Acurx were Dr. Michael Silverman, our Medical Director, who's with us this morning; 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 program.

David P. Luci: Kevin Garey, Professor and Chair, University of Houston College of Pharmacy, and the principal investigator for microbiology and microbiome aspects of the ibezapolstat clinical 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 the potential microbiome-sparing class effect of representative compounds from our DNA Pol IIIC inhibitor preclinical pipeline. In describing the work performed at his laboratory at the University of Houston, Dr. Garey stated, "Initial work on the novel lead DNA Pol IIIC inhibitor compounds indicate that the positive microbiome-sparing results from our ibezapolstat studies may be a class effect. This is an important finding because microbiome sparing likely contributed to ibezapolstat's sustained efficacy in the phase 2 trial for C. diff infection, where no patient cured of CDI experienced a recurrence.

Speaker #3: The company's presentation included an update on Abesopostat and its microbiome-sparing properties. Also presented were new colonic microbiome data from a state-of-the-art mouse infection model, showing the potential microbiome-sparing class effect of representative compounds from our DNA PAL3C inhibitor preclinical pipeline.

Speaker #3: In describing the work performed at his laboratory at the University of Houston, Dr. Gary stated, "Initial work on the novel lead DNA PAL3C inhibitor compounds indicates that the positive microbiome-sparing results from our Abesopostat studies may be a class effect."

Speaker #3: This is an important finding because microbiome sparing likely contributed to Abesopostat's sustained efficacy in the Phase 2 trial for C. diff infection, where no patient with cumulative CDI experienced a recurrence. In our recent experiments, mice given the comparator antibiotic, Linezolid, demonstrated an overabundance of uncommon and harmful gram-negative bacteria, known to contribute to recurrence of infection.

David P. Luci: In our recent experiments, mice given the comparator antibiotic, linezolid, demonstrated an overabundance of uncommon and harmful Gram-negative bacteria known to contribute to recurrence of infection. Dr. Gary further stated, "These data indicate a low probability for DNA Pol IIIC inhibitors to increase the risk of causing a C. diff infection, vancomycin-resistant enterococcus, or other gut microbiome-related infections." In November, the company announced that the Nature Communications scientific journal published results from its scientific collaboration with Leiden University Medical Center, demonstrating structural biology research that reveals for the first time a DNA Pol IIIC inhibitor, ibezapolstat, bound to its target.

Speaker #3: Dr. Gary further stated, "These data indicate a low probability for DNA PAL3C inhibitors to increase the risk of causing a C. diff infection, glycomycin-resistant enterococcus, or other gut microbiome-related infections." In November, the company announced that the Nature Communications scientific journal published results from its scientific collaboration with Leiden University Medical Center, demonstrating structural biology research that reveals, for the first time, a DNA PAL3C inhibitor, Abesopostat, bound to its target.

Speaker #3: The publication is entitled "A Unique Inhibitor Confirmation: Selectively Targets the DNA Polymerase PALC of Gram-Positive Priority Pathogens." This is an important milestone in Acurx's highly productive scientific collaboration with Leiden University Medical Center in Holland, 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.

David P. Luci: The publication is entitled "A Unique Inhibitor Conformation Selectively Targets the DNA Polymerase Pol C of Gram-Positive Priority Pathogens." This is an important milestone in Acurx's highly productive scientific collaboration with Leiden University Medical Center in Holland, 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. On 9 March 2026, we issued a press release announcing that we are launching a groundbreaking ibezapolstat clinical trial program in patients with recurrent CDI that has the potential to shift the treatment paradigm and the prevention of rCDI from two agents to one agent.

Speaker #3: On March 9, 2026, we issued a press release announcing that we are launching a groundbreaking Abesopostat clinical trial program in patients with recurrent CDI.

Speaker #3: That has the potential to shift the treatment paradigm, and the prevention of RCDI from two agents to one agent. When coupled with Abesopostat's Phase 2 results—being highly effective, with a 96% clinical cure in 26 patients in treating acute CDI with no recurrence in patients while sparing the gut microbiome—this new trial will position Abesopostat as a candidate to be the first agent to demonstrate clinical success in both the treatment of CDI and the prevention of recurrent CDI.

David P. Luci: When coupled with ibezapolstat's phase 2 results of being highly effective, 96% clinical cure in 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 recurrent CDI. In our phase 2 trial, all 25 patients treated with ibezapolstat who experienced a clinical cure were free of recurrence 1 month after treatment, and 5 out of 5 of these patients were observed for 3 months after treatment, and they remained free of recurrence. During our Q&A this morning, members of our R&D team will be available to answer any questions about this new trial program.

Speaker #3: In our Phase Two trial, all 25 patients treated with Abesopostat who experienced a clinical cure were free of recurrence one month after treatment, and five out of five of these patients were observed for three months after treatment, and they remained free of recurrence.

Speaker #3: During our Q&A this morning, members of our R&D team will be available to answer any questions about this new trial program. Briefly, this new clinical trial in RCDI begins with an open-label pilot trial to gain experience with Abesopostat in patients with multiply recurrent CDI.

David P. Luci: Briefly, this new clinical trial in rCDI begins with an open-label pilot trial to gain experience with ibezapolstat in patients with multiple 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 1-patient trial. Upon subsequent successful completion of the Phase 3 pivotal rCDI trial, and per the operative FDA procedure, the company 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.

Speaker #3: With at least three 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.

Speaker #3: Upon subsequent successful completion of the Phase 3 pivotal RCDI trial, and per the operative FDA procedure, the company 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.

Speaker #3: Published in 2020, Acurx's clinical program and the broader CDI patient population are ready to advance to phase three 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 the FDA's new default standard for registration.

David P. Luci: 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 for registration. If formalized, 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 February 2026, we announced that the US Patent and Trademark Office 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.

Speaker #3: If formalized, 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.

Speaker #3: Such as the opportunity to seek marketing approval for the broader CDI population with one pivotal clinical trial. In February 2026, we announced that the U.S. Patent and Trademark Office granted a new patent for our PAL3C inhibitors covering composition of matter and method of use.

Speaker #3: This patent extends to December 2039, subject to extension under US patent rules. We continue to identify and pursue funding opportunities for our phase three clinical trial programs for Abesopostat, as well as consideration of alternative financial pathways to achieve success.

David P. Luci: We continue to identify and pursue funding opportunities for our Phase 3 clinical trial programs for ibezapolstat, as well as consideration of alternative financial pathways to achieve success. We have several initiatives underway to this end, and we'll report in future updates as appropriate. As we've 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. Additionally, ibezapolstat has qualified infectious disease product and Fast Track designations from the FDA for the treatment of C. difficile infection, as well as SME or small and medium enterprise status in Europe.

Speaker #3: We have several initiatives underway to this end, and will report in future updates as appropriate. As we've continually reported, abesopostat clinical and non-clinical results continue to outperform in a serious and potentially life-threatening infectious disease, caused by a C.

Speaker #3: Difficile bacteria, which the CDC categorizes as an urgent threat, calls for new classes of antibiotics for initial treatment that also have a low incidence of recurrence.

Speaker #3: Additionally, Abesopostat has qualified infectious disease product and fast-track designations from the FDA for the treatment of C. difficile infection, as well as SME, or small and medium enterprise, status in Europe.

Speaker #3: We remain confident they're well. Development of Abesopostat's competitive profile continues to evolve and strengthen. We will continue to navigate successfully through these challenging times in the macroeconomic environment and in our industry sector.

David P. Luci: We remain confident that while development of ibezapolstat's competitive profile continues to evolve and strengthen, we will continue to navigate successfully through these challenging times in the macroeconomic environment and in our industry sector. Now back to our CFO, Rob Shawah, to guide you through the highlights of our financial results for the full year and Q4 ended December 31, 2025. Rob?

Speaker #3: And now, back to our CFO, Rob Shawah, to guide you through the highlights of our financial results for the full year and fourth quarter ended December 31, 2025.

Speaker #3: Rob, thanks. Dave, our financial results for the fourth quarter and year ended December 31, 2025, were included in our press release issued earlier this morning.

Robert G. Shawah: Thanks, Dave. Our financial results for Q4 and year ended December 31, 2025, were included in our press release issued earlier this morning. The company ended the year with cash totaling $7.6 million compared to $3.7 million as of December 31, 2024. During the 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 million for the full year of 2025. 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.

Speaker #3: The company ended the year with cash totaling $7.6 million, compared to $3.7 million as of December 31, 2024. During the quarter, the company raised a total of approximately $1.5 million of gross proceeds through purchases under the equity line of credit.

Speaker #3: With gross proceeds of purchases under the equity line of credit totaling approximately $4 million for the full year of 2025. 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.

Speaker #3: 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 prior year trial-related expenses.

Robert G. Shawah: 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 prior year trial-related expenses. For the 12 months ended December 31, 2025, research and development expenses were $1.8 million versus $5.4 million for the 12 months ended December 31, 2024. The decrease of $3.6 million was primarily due to a reduction of $2.6 million in manufacturing-related costs and a $1 million decrease in consulting costs, as prior year had higher expenses related to Phase 2b and Phase 3 preparation costs.

Speaker #3: For the 12 months ended December 31, 2025, research and development expenses were $1.8 million, versus $5.4 million for the 12 months ended December 31, 2024.

Speaker #3: The decrease of $3.6 million was primarily due to a reduction of $2.6 million in manufacturing-related costs and a $1.0 million decrease in consulting costs.

Speaker #3: As prior year had higher expenses related to Phase 2B and Phase 3 preparation costs. General and administrative expenses for the three months ended December 31, 2025, were $1.3 million.

Robert G. Shawah: General and administrative expenses for the three months ended 31 December 2025 were $1.3 million compared to $2 million for the three months ended 31 December 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.

Speaker #3: 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.

Speaker #3: For the 12 months ended December 31, 2025, general and administrative expenses were $6.3 million, versus $8.7 million for the 12 months ended December 31, 2024.

Robert G. Shawah: For the 12 months ended December 31, 2025, general and administrative expenses were $6.3 million versus $8.7 million for the 12 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, a $1.4 million decrease in share-based compensation, a $0.4 million decrease in compensation costs, partially offset by a $0.3 million increase in legal costs. 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.

Speaker #3: A decrease of $2.4 million. The decrease was primarily due to a $0.9 million decrease in professional fees, a $1.4 million decrease in share-based compensation, and a $0.4 million decrease in compensation costs, partially offset by a $0.3 million increase in legal costs.

Speaker #3: 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.

Speaker #3: And a net loss of $8.0 million, or $5.32 per diluted share, for the 12 months ended December 31, 2025, compared to a net loss of $14.1 million, or $17.45 per share, for the 12 months ended December 31, 2024.

Robert G. Shawah: A net loss of $8 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. With that, I'll turn the call back over to Dave.

Speaker #3: All for the reasons previously mentioned. The company had 2,348,113 shares outstanding as of December 31, 2025. With that, I'll turn the call back over to Dave.

Speaker #2: Thanks, Rob. And to all of you for joining us today. Before bringing our operator, Donna, back to open the call for questions, I'm pleased to welcome to the call Michael Silverman and Bob DeLucia, our medical director and executive chairman, respectively.

David P. Luci: Thanks, Rob, and to all of you for joining us today. Before bringing our operator, Donna, back to open the call for questions, I'm pleased to welcome to the call Michael Silverman and Bob DeLuccia, our Medical Director and Executive Chairman, respectively, to assist with further explanation of our recurrent C. difficile infection trial program. Bob, would you like to add any comments?

Speaker #2: To assist with further explanation of our recurrent C. difficile infection trial program, Bob, would you like to add any comments?

Speaker #3: Sure. Thanks, Dave. And as you said, these are very challenging times, but we think we can rise above them, head-on, with our new clinical development plan.

Robert J. DeLuccia: Sure. Thanks, Dave. As you said, you know, these are very challenging times, but we think we can rise above them head on with our new clinical development plan. I think in phase 2, as Dave said, ibezapolstat was demonstrated to be highly effective in both curing the acute C. diff infection and in preventing recurrence. Based on this, we believe it has the potential to be the first to demonstrate clinical success in both the treatment of the infection and the prevention of recurrent CDI. Such success would shift the paradigm of treatment and prevention of rCDI from two agents to one.

Speaker #3: I think in Phase 2, as Dave said, Abesopostat was demonstrated to be highly effective in both curing the acute C. diff infection and in preventing recurrence.

Speaker #3: So, based on this, we believe it has the potential to be the first to demonstrate clinical success in both the treatment of the infection and the prevention of recurrent CDI.

Speaker #3: And such success would shift the paradigm of treatment and prevention of RCDI from two agents to one. And I think this would be a game-changer to the public health threat that affects approximately 500,000 patients with CDI each year in the US, results in approximately 30,000 deaths, and generates a related public health cost burden of approximately $2.8 billion, which is related to recurrent CDI.

Robert J. DeLuccia: I think this would be a game changer to the public health threat that affects approximately 500,000 patients with CDI each year in the US, results in approximately 30,000 deaths, and it generates a related public health cost burden of approximately $5 billion, of which $2.8 billion is related to recurrent CDI. I also think that our new clinical program strengthens ibezapolstat's competitiveness, and if approved for marketing, gives an even more attractive value proposition in the marketplace, and which, by the way, ibezapolstat commercial supply chain of active pharmaceutical ingredient and packaged product will be made in America. Thanks, Dave.

Speaker #3: I also think that our new clinical program strengthens Abesopostat's competitiveness, and, if approved for marketing, gives it an even more attractive value proposition in the marketplace.

Speaker #3: And which, by the way, Abesopostat commercial supply chain of active pharmaceutical ingredient and packaged product will be made in America. Thanks, Dave.

Speaker #2: Thanks, Bob. And now back to Donna, our operator for today's call for questions. Donna?

David P. Luci: Thanks, Bob. Back to Donna, our operator for today's call for questions. Donna?

Speaker #4: Thank you. Ladies and gentlemen, the floor is now open for questions. If you would like to ask a question, please press star one on your telephone keypad at this time.

Operator: Thank you. Ladies and gentlemen, the floor is now open for questions. If you would like to ask a question, please press star one on your telephone keypad at this time. A confirmation tone will indicate that your line is in the question queue. You may press star two if you would like to remove your question from the queue. For participants using speaker equipment, it may be necessary to pick up the handset before pressing the star keys. Again, that's star one to register a question at this time. Today's first question is coming from Jason McCarthy of Maxim Group. Please go ahead.

Speaker #4: A confirmation tone will indicate that your line is in the question queue. You may press star two (*) if you would like to remove your question from the queue.

Speaker #4: For participants using speaker equipment, it may be necessary to pick up the handset before pressing the star keys. Again, that's star one (*) to register a question at this time.

Speaker #4: Today's first question is coming from Jason McCarthy of Maxim Group. Please go ahead.

Speaker #5: Go ahead.

Speaker #6: Good morning, guys. Thanks for taking the questions. I have a few, so if you'd just bear with me. Starting with the new recurrent CDI trial, for the primary endpoint—for, I'm assuming, its prevention of recurrence—how far out do you have to go?

Jason McCarthy: Good morning, guys. Thanks for taking the questions. I have a few, so if you just bear with me. Starting with the new recurrent CDI trial, for the primary endpoint, I'm assuming it's prevention of a recurrence, how far out do you have to go? Is it three months, six months, one month, and so on? What is the cost of that trial?

Speaker #6: Is it three months, six months, one month, and so on? And what is the cost of that trial?

Speaker #2: Bob?

David P. Luci: Bob?

Speaker #3: Yeah. First question was, how far out do you mean in terms of evaluation through the endpoint? How long?

Robert J. DeLuccia: Yeah. First question was how far out you mean in terms of evaluation through the endpoint? How long?

Speaker #6: Yes, sir.

Jason McCarthy: Yes, sir. Mm-hmm.

Speaker #3: Yeah, Mike, you can take that question if you like. Just explain the treatment period as well as the follow-up period.

Robert J. DeLuccia: Yeah. Mike, you can take that question if you like. Just explain the treatment period as well as the follow-up period.

Speaker #7: Sure. Thanks for the question, Michael Silverman here. Following the end of treatment, we'll observe patients for recurrent disease to a first endpoint, a primary assessment endpoint of eight weeks.

Michael Silverman: Sure. Thanks for the question, Michael Silverman here. Following the end of treatment, we will observe patients with recurrent disease to a first endpoint, a primary assessment endpoint of eight weeks. That's based on other products that are out there having been approved for prevention of recurrent disease. The standard there has been eight weeks. The precedent has been eight weeks. That will be our endpoint for recurrent disease. We will continue to follow patients out for approximately six months after the end of therapy to gather additional data.

Speaker #7: That's based on other products that are out there having been approved for prevention of recurrent disease. The standard there has been eight weeks; the precedent has been eight weeks.

Speaker #7: So that will be our endpoint for recurrent disease. We will continue to follow patients out for approximately six months after the end of therapy to gather additional data.

Speaker #6: Okay. Just as a follow-up to that, when you go out to six months in general, what do you see as the rate of recurrence with bank or any other treatment that they're getting?

Jason McCarthy: Okay. Just as a follow-up to that, when you go out to six months in general, what do you see as the rate of recurrence with vanc or any other treatment that they're getting on average?

Speaker #6: On average.

Michael Silverman: Yeah, it's a good question. Thanks. We may not have data out to six weeks on the drugs that are out there. That has not necessarily been the standard follow-up. Vancomycin, we can see rates of recurrence between 20% and 40%, you know, for the anti-recurrence therapies that are out there, like.

Speaker #7: Yeah, it's a good question. Thanks. We may not have data out to six weeks on the drugs that are out there. That has not necessarily been the standard follow-up.

Speaker #7: With vancomycin, we can see rates of recurrence between 20% and 40%. For the anti-recurrence therapies that are out there, like VOS and Rebyota, those recurrence rates are down in the range of 15% to 30%.

Michael Silverman: Vowst and Rebyota, those recurrence rates are down in the range of 15 to 30%. I'm talking about FDA label indication.

Speaker #7: And I'm talking about the eight-week label indication.

Speaker #3: Okay, Jason.

Robert J. DeLuccia: Okay, Jason?

Jason McCarthy: Got it. Yes.

Speaker #6: Got it. Yes.

Speaker #3: Good. Dave, do you want to address the— Dave, do you want to address the cost question?

Robert J. DeLuccia: Good. Dave, you wanna address the-

Michael Silverman: Thank you.

Robert J. DeLuccia: Dave, you wanna address the cost question?

Speaker #2: The only thing I think we left out is the treatment period. I think there's a small modification to that, Jason. Bob, do you want to provide that?

David P. Luci: The only thing I think we left out is the treatment period. I think there's a small-

Jason McCarthy: Got it.

David P. Luci: Modification to that, Jason.

Robert J. DeLuccia: Yeah.

David P. Luci: Bob, do you wanna provide that?

Speaker #3: Yeah. Go ahead, Mike. The initial treatment of...

Robert J. DeLuccia: Yeah, go ahead, Mike. The initial treatment

Michael Silverman: Sure. You may recall that in our prior trials we've used 10-day treatment period because again, that's been standard of practice, the standard of care.

Speaker #7: Sure. You may recall that in our prior trials, we've used a 10-day treatment period because, again, that's been standard of practice, standard of care for the other drugs that are approved—vancomycin, fidaxomicin.

Jason McCarthy: Mm-hmm.

Michael Silverman: For the other drugs that have improved, vancomycin, fidaxomicin. For this trial, for the recurrent disease trial, we're going to a 14-day treatment period for all patients. That's based on prior work that's been done with the anti-recurrence drug. With the anti-recurrence agents, longer period of treatment for the acute episode may result in a higher cure rate, which would give us a more robust sample size in which to evaluate recurrence.

Speaker #7: For this trial, for the recurrent disease trial, we're going to a 14-day treatment period for all patients. And that's based on prior work that's been done in the anti-recurrence drug with the anti-recurrence agents.

Speaker #7: A longer period of treatment for the acute episode may result in a higher cure rate, which would give us a more robust sample size with which to evaluate recurrence.

Speaker #6: Got it. And the cost-ish?

Jason McCarthy: Got it. The cost-ish.

Speaker #3: Dave?

Speaker #2: Yeah, it's in the range of $4 to $5 million.

Robert J. DeLuccia: Dave?

David P. Luci: Yeah, it's in the range of $4 to 5 million.

Speaker #6: So it's likely that the current cash balance, maybe with a little bit of a top-off, gets you through this—I guess we call it a pilot study in recurrent CDI—and is that something that we could see the start and conclusion of in 2026?

Jason McCarthy: It's likely that the current cash balance, maybe with a little bit of a top off, gets you through this. I guess we call it a pilot study in recurrent CDI, and is that something that we could see, the start and conclusion of in 2026?

Speaker #2: Oh, we'll certainly start enrolling in 2026, in the second half. But then we'll see how far we get with the enrollment. We think we have some really high-enrolling centers, but we wouldn't expect to be fully enrolled for about 12 to 15 months.

David P. Luci: Oh, we'll certainly start enrolling in 2026, in the second half. You know, we'll see how far we get with the enrollment. We think we have some really high enrolling centers, we wouldn't expect to be fully enrolled for about 12 to 15 months.

Speaker #6: Okay. Okay.

Jason McCarthy: Okay.

Speaker #2: And yes, I should add, Jason, that we also have our ELOC, right? So, in terms of topping off, we have between $7 million and $8 million left on our ELOC.

David P. Luci: Yeah. I should add, Jason, that we also have our ELOC, right? In terms of topping off, you know, we have between $7 million and $8 million left on our ELOC.

Speaker #6: Okay, good, perfect. And then just two more quick ones, and then I'll jump back. So if this pilot is successful, does it change—when you start to think about recurrent CDI for the phase three—does that change the size, the potential size of a phase three?

Jason McCarthy: Okay. Good. Perfect. Then just two more quick ones, and then I'll jump back. If this pilot is successful, does it change, and you're starting to think about recurrent CDI, for the Phase 3, does that change the size, the potential size of a Phase 3? 'Cause if it was acute, I think it was somewhere in that 400 to 500 patients per trial. Two Phase 3s, I know that the narrative seems to be changing to one Phase 3 these days, but just for recurrent CDI in general, do you need less patients to get an approval versus acute?

Speaker #6: Because if it was acute, I think it was somewhere in that 400 to 500 patients per trial. Two phase threes—I know that narrative seems to be changing to one phase three these days.

Speaker #6: But just for recurrent CDI in general, do you need fewer patients to get an approval versus acute?

Speaker #3: Yeah, I think—thank you, Jason, for that question. Mike, you can answer that in terms of what we are projecting for the follow-on trial to the open-label.

Robert J. DeLuccia: Yeah. Thank you, Jason, for that question. Mike, you can answer that in terms of what we're projecting for the follow-on trial to the open label. We have a range of estimates right now, but it depends upon what we see in the open label trial. Mike?

Speaker #3: We have a range of estimates right now, but it depends upon what we see in the open-label trial, right?

Speaker #7: Yeah, I'd like to emphasize what Bob said. Right now, we don't have any treatment data, as opposed to in this patient population. So we don't know the true effect size.

Michael Silverman: Yeah. I'd like to emphasize what Bob said. Right now we don't have any treatment data with ibezapolstat in this patient population, so we don't know the true effect size. We have very good estimates of the other agents that are out there, Jason, as you mentioned. We still need to gather the data on the ibezapolstat in terms of clinical cure rate and prevention of recurrence.

Speaker #7: We have very good estimates of the other agents that are out there, Jason, as you mentioned. But we still need to gather the data on the Abesapol set in terms of clinical cure rate and prevention of recurrence.

Speaker #7: Based on what we think are reasonable assumptions—that is, going back to our phase two trial in a slightly different patient population—we're currently projecting somewhere between 360 and 400 patients for a single trial in the recurrent CDI indication.

Jason McCarthy: Right.

Michael Silverman: what we think are reasonable assumptions, that is, going back to our Phase 2 trial in a slightly different patient population, we're currently projecting somewhere between 360 and 400 patients for a single trial in the recurrent CDI indication.

Speaker #6: Got it. Okay. That makes sense. And then just lastly, I know you guys had mentioned U.S.-based manufacturing, which seems to be a very important issue these days with the current administration.

Jason McCarthy: Got it. Okay, that makes sense. Just lastly, I know you guys you had mentioned US-based manufacturing, which seems to be a very important issue these days with the current administration. Is that something that you're really trying to make headway with regulators on or the current administration in terms of? You could see a Pol IIIC inhibitor being used in lots of different things. Maybe it's something the government is interested in stockpiling. Dave, do you wanna just kinda opine, if you would, on that aspect of the US-based manufacturing?

Speaker #6: Is that something that you're really trying to make headway with regulators on? Or the current administration, in terms of having IBEZA? You could see a Pull-3C inhibitor being used in lots of different things.

Speaker #6: Maybe it's something the government is interested in stockpiling. Dave, do you want to just kind of opine, if you would, on that aspect of the US-based manufacturing?

Speaker #2: Yeah, I think you've hit it pretty straight on, Jason. We're continuing to have detailed discussions with government agencies, including BARDA, and it's important to them, in their consideration of a public-private partnership, that our program be made in America.

David P. Luci: Yeah. I think.

Robert J. DeLuccia: Yeah.

David P. Luci: I think you hit it pretty straight on, Jason. You know, we're continuing to have detailed discussions with government agencies, including BARDA. You know, it's important to them in their consideration of a public-private partnership that our program be made in America. So that's part of what makes them excited about getting appropriate funding allocated, you know, to each sponsor that's looking for government money. As you say, these days under this administration.

Speaker #2: So that's part of what makes them excited about getting appropriate funding allocated to each sponsor that's looking for government money. As you say, these days, under this administration.

Speaker #3: Yeah, I agree, Dave. And I think the point about potential government stockpiling on these—one of the things that's working in our favor is that IBEZA, PUL-521, and PUL-C3s in general are very stable over time.

Robert J. DeLuccia: Yeah. I agree, Dave, and I think the point about potential government stockpiling on these, one of the things that's working in our favor is that, ibezapolstat and Pol IIIC inhibitors in general are very stable over time. Our ibezapolstat API right now we have about 48 months stability and probably closer to 5 years stability, and similar long-term stability in package form. That makes it prime for stockpiling.

Speaker #3: Our IBEZA pulse, that API right now, we have about 48 months' stability and probably close to five years—sorry, 48 months and closer to five years' stability—and similar length stability in package form.

Speaker #3: So that makes it prime for stockpiling.

Speaker #2: Yeah. Jason, I'd just like to have one other little one for you. In one of my conversations on Capitol Hill, I heard from a former Navy pilot that MRSA is kind of burgeoning greatly in Navy ships.

David P. Luci: Yeah, Jason, I'd just like to have one other little one for you. You know, in one of my conversations on Capitol Hill, I heard from a former Navy pilot that MRSA is, you know, kind of burgeoning greatly on Navy ships. The government apparently is looking for a new pipeline in that area. As you know, we have something for that.

Speaker #2: So the government apparently is looking for a new pipeline in that area. As you know, we have something for that.

Speaker #3: Yeah.

Robert J. DeLuccia: Yeah.

Speaker #6: Okay, I think that's all my questions for now. Thank you for taking the time. I appreciate it.

Jason McCarthy: Okay. I think that's all my questions, for now. Thank you, for taking the time. Appreciate it.

Speaker #3: No problem. Thank you.

Robert J. DeLuccia: No problem. Thank you.

Speaker #1: Thank you. Our next question is coming from James Maboy of Alliance Global Partners. Please go ahead.

Operator: Thank you. Our next question is coming from James Molloy of Alliance Global Partners. Please go ahead.

Speaker #8: Hey guys, good morning. Thank you for taking my questions. Two follow-ups, more on what Jason said. I asked on the timings. In the March 9th—or the March 9th—press release, you said the first patient here in the Phase 2, fourth quarter '26.

James Molloy: Hey, guys. Good morning. Thank you for taking my questions. Just wanna follow up on more on what Jason said or asked on the timings. In the 9 March press release, you said the first patient here in the Phase 2, Q4 2026. Should we understand correctly it'll be 12 to 18 months after the Q4 of this year for this Phase 2 to fully enroll?

James Molloy (Alliance Global Partners: Hey, guys. Good morning. Thank you for taking my questions. Just wanna follow up on more on what Jason said or asked on the timings. In the 9 March press release, you said the first patient here in the Phase 2, Q4 2026. Should we understand correctly it'll be 12 to 18 months after the Q4 of this year for this Phase 2 to fully enroll?

Speaker #8: Should we understand correctly, it would be 12 to 18 months after the fourth quarter of this year for this Phase Two to fully enroll?

Speaker #3: Yeah, so sometime in the fourth quarter, plus 12 to 15 months.

Robert J. DeLuccia: Yeah. You know.

James Molloy: Yeah.

James Molloy (Alliance Global Partners: Yeah.

Robert J. DeLuccia: Sometime in Q4 plus 12 to 15 months.

Speaker #8: Okay, and then obviously, the Phase 3 wouldn't start until some point after that.

James Molloy: Okay. Obviously the phase 3 wouldn't start until some point after that.

James Molloy (Alliance Global Partners: Okay. Obviously the phase 3 wouldn't start until some point after that.

Speaker #3: Correct.

Robert J. DeLuccia: Correct.

Speaker #8: Would it be possible that Phase Three would start, you could get interim data, and the Phase Three might start if things change during that trial?

James Molloy: It's possible the Phase 3 could start, you could get interim data, and the Phase 3 might start if things change during that trial.

James Molloy (Alliance Global Partners: It's possible the Phase 3 could start, you could get interim data, and the Phase 3 might start if things change during that trial.

Speaker #3: Say that again. Yeah, can you repeat that, Jason?

Robert J. DeLuccia: I'm sorry. Can you repeat that, Jason?

Speaker #8: Is there any chance it could be an interim data out of the Phase 2 that might spur the Phase 3 to start? Or at this point, going down this path, the Phase 3 confirmatory would not start until this Phase 2 is done?

James Molloy: Is there any chance there can be an interim any interim data out of the Phase 2 that might spur the Phase 3 to start? At this point, going down this path, the Phase 3 trial would not start until this Phase 2 is done.

James Molloy (Alliance Global Partners: Is there any chance there can be an interim any interim data out of the Phase 2 that might spur the Phase 3 to start? At this point, going down this path, the Phase 3 trial would not start until this Phase 2 is done.

Speaker #3: Yeah, I mean, it's possible, Dave and Mike. You can comment on that again. But we really would like to see the full 20 patients for decision-making and being best to size the following trial, the control trial.

Robert J. DeLuccia: Yeah. I mean, it's possible. Dave or Mike, you can comment on that again, but we really would like to see the full 20 patients, you know, for decision-making and being best to size the following trial, the control trial. Mike or Dave?

Speaker #3: Mike, or Dave?

David P. Luci: Yeah, I mean.

Speaker #2: Yeah, I mean, go ahead, Mike.

Michael Silverman: Go ahead, Mike.

Michael Silverman: It gives us confidence.

Speaker #3: You'll give us confidence. Yeah.

Robert J. DeLuccia: Yeah.

Speaker #8: Yeah, it's a balance, but I agree with Bob. The more data we have, the more confidence we have in being able to start to size the Phase 3 trial.

Michael Silverman: Yeah. Yeah. It's a balance, but I agree with Bob. The more data we have, the more confidence we have in being able to size the Phase 3 trial. We can certainly get started with preparatory activities if we're encouraged. As Bob said, the more data we get, the better off we'll be.

Speaker #8: We can certainly get started with preparatory activities if we're encouraged, but as Bob said, the more data we get, the better off we'll be.

Speaker #3: Yeah. And I guess I would just like to put an asterisk on it. Understanding we ended our Phase 2a in acute CDI early, and the 2b, we ended early.

Robert J. DeLuccia: Yeah. You know, I guess I would just like to put an asterisk on it, you know, understanding we ended our Phase 2a in acute CDI early, and the 2b, we ended early. You know, we're gonna take a preliminary look at the first 10 patients, and, you know, we'll be able to call an audible if our Scientific Advisory Board feels it's appropriate.

Speaker #3: We're going to take a preliminary look at the first 10 patients, and we'll be able to call an audible if our scientific advisory board feels it's appropriate.

Speaker #8: And would that be—would that audible happen on the first 10 patients, potentially after the eight weeks, or would you wait the full six months?

James Molloy: Would that be a follow-up happen on the first 10 patients potentially after the 8 weeks, or would you wait the full 6 months?

James Molloy (Alliance Global Partners: Would that be a follow-up happen on the first 10 patients potentially after the 8 weeks, or would you wait the full 6 months?

Speaker #3: Say that again.

Robert J. DeLuccia: It would depend on what the R&D guys think. I would imagine it would be after the 8 weeks, because I don't think many of these programs have been evaluated for 6 months.

Speaker #2: It would depend on what the R&D guys think. I would imagine it would be after the eight weeks, because I don't think many of these programs have been evaluated for six months.

Robert J. DeLuccia: It would depend on what the R&D guys think. I would imagine it would be after the 8 weeks, because I don't think many of these programs have been evaluated for 6 months.

Speaker #3: Yeah.

David P. Luci: The most important endpoint is 8 weeks, Dave.

Speaker #8: Most important endpoint is eight weeks, Dave.

Speaker #3: Yeah. Yeah.

Robert J. DeLuccia: Yeah. Yeah.

Speaker #8: Okay. And then maybe hard to answer this one, but I know that you talked about the one-trial deal getting away from the two-trial dogma.

James Molloy: Okay. Then, maybe it may be hard to answer this one, but I know the. You talk about the one trial deal, getting away from the two trial dogma. Speaking with a number of other companies who've gone in front of the FDA, obviously a lot of things have been said about trying to speed things up, and make some changes to the clinical trial procedure. But some of these other companies we spoke with have not found really much difference when they actually approach the FDA. They still are facing the folks, same people beneath. It may be early to say, but how real do they think the one trial might be?

James Molloy (Alliance Global Partners: Okay. Then, maybe it may be hard to answer this one, but I know the. You talk about the one trial deal, getting away from the two trial dogma. Speaking with a number of other companies who've gone in front of the FDA, obviously a lot of things have been said about trying to speed things up, and make some changes to the clinical trial procedure. But some of these other companies we spoke with have not found really much difference when they actually approach the FDA. They still are facing the folks, same people beneath. It may be early to say, but how real do they think the one trial might be?

Speaker #8: Speaking with a number of other companies, we've gone in front of the FDA. Obviously, a lot of things have been said about trying to speed things up.

Speaker #8: And make some changes to the clinical trial procedure. But some of these other companies we spoke with have not found really much difference when they actually approach the FDA.

Speaker #8: They still are facing the folks saying people beneath. How—maybe early to say, but how really do you think the one trial might be?

Speaker #3: Maybe. Maybe I can take that one, Dave. I'm pretty encouraged, and I think that is going to be a game changer here. As well as a number of other things, we have—one of our scientific advisors is Mark Goldberger, who is a former head of the Antimicrobials Division at the FDA.

Robert J. DeLuccia: Maybe I can take that one, Dave. I'm pretty encouraged that I think that is gonna be a game changer here, as well as a number of other things. We have one of our scientific advisors is Mark Goldberg, who's the former head of the antimicrobials division at the FDA. You know, his read on it, what has to happen next is that this needs to be formalized. They'll probably, and we believe they're already working on a guidance for industry to clarify some of the questions and lay down the parameters, for what that would be. In our case, as I think one of, maybe, Jason mentioned this as well too, we had currently planned to do a roughly 474-patient, two trials, excuse me, non-inferiority to vanco.

Speaker #3: And his read on it, what has to happen next is that this needs to be formalized, so they'll probably—and we believe they're already working on—a guidance for industry to clarify some of the questions and lay down the parameters for what that would be.

Speaker #3: In our case, as I think one of maybe Jason mentioned this as well too, we had currently planned to do a 470 roughly 474 patient one trial two trials, excuse me, non-inferiority to vanco if we only have to do one trial, maybe we'll bump that up a little bit so that we cover the safety database with one trial.

Robert J. DeLuccia: If we only have to do one trial, maybe we'll bump that up a little bit so that we cover the safety database with one trial. We're poised and ready to talk to FDA at the appropriate time. Things need to settle down before they actually get all their ducks in a row and sort of codify it. Does that help?

Speaker #3: But we're poised and ready to talk to the FDA at the appropriate time. And things need to settle down before they actually get all their ducks in a row and sort of codify it.

Speaker #3: Does that help?

Speaker #2: Yeah, indeed. Just to add on to what Bob said—looking at it from the top down, Jim—and you can see this on our website, it takes the government time, but we have time for this change to go into effect.

David P. Luci: Mm-hmm.

Robert J. DeLuccia: You know, just to add on to what Bob said, you know, looking at it from the top down, Jim, and you can see this on our website, it takes the government, you know, time, but we have time, for this change to go into effect because we have the 20-patient trial in front of us. The paper talking about ending the two-trial dogma was co-authored by Marty Makary, the head of the FDA.

Speaker #2: Because we have the 20-patient trial in front of us. And the paper talking about ending the two-trial dogma was co-authored by Marty McCary, the head of the FDA.

David P. Luci: That's on our website. It's in The New England Journal of Medicine. Certainly, if there's going to be a change in this regard, Marty Makary is the guy that you would wanna see as a co-author on the paper.

Speaker #2: That's on our website. It's in the New England Journal of Medicine. But certainly, if there's going to be a change in this regard, Marty McCary is the guy that you would want to see as a co-author on the paper.

Speaker #8: Oh no, I've certainly seen it. I've seen it around, with a lot of talk about the changes. They do need to get their ducks in a row still.

James Molloy: Oh, no, I've certainly seen it. I've seen it around, heard a lot of talk about the changes. They do need to get their ducks in a row still, so it's a bit of a duck thing still. I hope that certainly comes to pass.

James Molloy (Alliance Global Partners: Oh, no, I've certainly seen it. I've seen it around, heard a lot of talk about the changes. They do need to get their ducks in a row still, so it's a bit of a duck thing still. I hope that certainly comes to pass.

Speaker #8: So it's a bit of a duck thing still, but I hope that certainly comes to pass. All right, great. Thank you for taking the questions.

David P. Luci: Yeah.

James Molloy: All right, great. Thank you for taking the questions.

James Molloy (Alliance Global Partners: All right, great. Thank you for taking the questions.

Speaker #2: Thank you, Jim.

David P. Luci: Thank you, Jim.

Speaker #1: Thank you. Once again, ladies and gentlemen, if you do have a question, please press star one on your telephone keypad at this point in time.

Operator: Thank you. Once again, ladies and gentlemen, if you do have a question, please press star one on your telephone keypad at this time. We'll pause a moment for any additional questions. We're showing no questions in the queue at this time. This concludes today's event. We'd like to thank you for your interest in Acurx Pharmaceuticals. You may disconnect your lines and enjoy your day.

Speaker #1: We'll pause a moment for any additional questions. We're showing no questions in the queue at this time. This concludes today's event. We'd like to thank you for your interest in Acurx Pharmaceuticals.

Speaker #1: You may disconnect your lines and enjoy your day.

David P. Luci: Thank you, Donna.

James Molloy: Thank you, everybody.

James Molloy (Alliance Global Partners: Thank you, everybody.

David P. Luci: You be well.

Q4 2025 Acurx Pharmaceuticals Inc Earnings Call

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