Q4 2023 Acurx Pharmaceuticals Inc Earnings Call

Operator: Greetings and welcome to the Acurx Pharmaceuticals 4th Quarter and Full Year 2023 Earnings Results and Business Updates. At this time, all participants are in a listen-only mode.

Greetings and welcome to the Acura Pharmaceuticals reports fourth quarter and full year 2023 earnings results and business update call. At this time all participants are in a listen only mode. A question and answer session will follow the formal presentation. If anyone should require operator assistance. During the conference. Please press star zero on your telephone keypad.

Operator: A question-and-answer session will follow the formal presentation. If anyone should require operator assistance during the conference, please press star zero on your telephone keypad. As a reminder, this conference is being recorded. I would now like to turn the call over to your host, Rob Shawah, Chief Financial Officer of Acurx Pharmaceuticals. Thank you.

As a reminder, this conference is being recorded I would now like to turn the call over to your host rock Sharla, Chief Financial Officer for Acura Pharmaceuticals. Thank you you may begin.

Thank you Melissa good morning, and welcome to our call.

Robert G. Shawah: Good morning, and welcome to our call. This morning, we issued a press release providing financial results and company highlights for the fourth quarter and full year 2023, which is available on our website at acurxpharma.com. Joining me today is David Lucci, President and CEO of Acurx, as well as Robert DeLuccia, Executive Chairman. David will give a corporate update and outlook. After that, I'll provide some highlights of the financials for the quarter and year end of December 31, 2023, and then turn the call back over to Dave for his closing remarks. As a reminder, during today's call, we'll be making certain forward-looking statements. These forward-looking statements 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 statement.

This morning, we issued a press release, providing financial results and company highlights for the fourth quarter and full year 2023, which is available on our website at Aker ex pharma dotcom.

Joining me today is David Lucci, President and CEO of Aker X as.

As well as Robert Deluccia Executive Chairman.

David will give a corporate update and outlook.

After that I'll provide some highlights of the financials from the quarter and year ended December 31, 2023, and then turn the call back over to Dave for his closing remarks.

As a reminder, during today's call, we'll be making certain forward looking statements.

These forward looking statements 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: Investors should consider these risks and other information described in our filings made with the Securities and Exchange Commission, including our annual report on Form 10-K, which we filed on Friday, March 15, 2024. You are cautioned not to place undue reliance on these forward-looking statements, and Acurrex disclaims any obligation to update such statements at any time. This conference call contains time-sensitive information that's accurate only as of the date of this live broadcast, today, March 18th, 2024. I'll now turn the call over to Dave Lucci. Dave?

Investors should consider these risks and other information described in our filings made with the Securities and Exchange Commission, including our annual report on Form 10-K, which we filed on Friday March 15th 2024.

You are cautioned not to place undue reliance on these forward looking statements and accurate 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 March 18th 2024.

I'll now turn the call over to Dave Lucci, Dave.

David P. Luci: Thanks, Rob. Good morning, everyone. And thanks for joining us to review our financial results for the fourth quarter of 2023 and also to hear some very exciting recent updates. Then we'd be pleased to take any questions. First, I'll summarize some of our key activities for the fourth quarter of 2023 or, in some cases, shortly thereafter.

Thanks, Rob and good morning, everyone and thanks for joining us to review our financial results for the fourth quarter of 2023 and also to hear some very exciting recent updates.

We'd be pleased to take any questions.

First I'll summarize some of our key activities for the fourth quarter of 'twenty three or in some cases shortly thereafter.

David P. Luci: On October 2, 2023, we ended enrollment in our Phase IIb clinical trial of ibezipolis fat, or IBEZ, our lead antibiotic candidate for the treatment of patients with C. difficile infection or CDI. On November 2nd, 2023, we reported top live data from the Phase IIb clinical trial, including overall results from the full Phase II study demonstrating an adverse pulse that clinical cure rate at the end of 10 days oral treatment, or EOT, of 96%. 25 of 26 patients, which included 100% cure in phase 2A and 94% cure in phase 2B. Compared with the vancomycin control arm, which was 14 for 14 or 100% at the end of treatment, and 94% achieved sustained cure. No safety concerns were reported in either arm of the Phase IIb clinical trial.

On October 2nd 2023, we entered enrollment in our phase two b clinical trial desert pools that we're I guess, our lead antibiotic candidate for the treatment of patients with C difficile infection or CDI.

In November 2023, we reported top line data from the phase two b clinical trial.

Overall results from the phase two study demonstrating that as opposed to a clinical cure rate and a 10 days oral treatment or E. N. G of 96% 25, 26 patients, which included 100% sure in phase III.

94% you are in place to be compared with vancomycin control arm standards.

Which was 14 for 14 or 100% at end of treatment.

94% was just eight years.

No safety concerns were reported in either arm of the phase III clinical trial.

David P. Luci: An advenza pulse that was well-tolerated in all patients in both the Phase IIa open-label trial and the Phase IIb vecomycin-controlled set. In consultation with our scientific advisors, the company determined that, based on review of aggregate blinded data, the Phase IIb Vecum Isotope Control trial segment was terminated early due to success showing high observed clinical cure rates with no emerging safety concerns; clinical compar We also stated that further data would be provided as it becomes available on secondary and exploratory endpoints for the Phase 2B trial segment, including sustained clinical cure data at 30 days after EOT and extended clinical cure data 94 days after EOT, as well as comparative data on the impact on the patient's microbiome. On December 11th, 23, we announced the sustained clinical cure data.

That was well tolerated in all patients in both the phase Iia open label trial.

The phase two be vancomycin controlled set.

In consultation with our scientific advisors the company determined that based on review of aggregate why are you doing this.

Phase two would be vancomycin control Ah trial segment was terminated early.

So it's showing high observed clinical cure rates with no emerging safety insurance clinical comparability was established.

We also see is that that's a further and further data would be provided as it becomes available on secondary and exploratory endpoints.

Phase two b trial segment, including sustained clinical cure data at 30 days after E M T.

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Clinical cure data 94 days after he and his team as well as comparative data on the impact on the patient's microbiome.

On December 11, 23, we announced a sustained clinical pure data. These data showed that in the face of the child checkmate, 100% or 15 of 15 of our best patients who were cured at E. L. T remains true with no reinfection 30 days later, while vancomycin experienced <unk>.

David P. Luci: These data showed that in the phase two B trial segment, 100%, or 15 of 15 of our IBEZ patients who were cured at EOT remained cured with no reinfection 30 days later, while vancomycin experienced a reinfection rate of 14.3%. Two of 14 patients were reinfected. On January 17, 2024, we announced positive comparative microbiology and microbiome data for ibezapolstat and TDI patients from the Phase IIb clinical trial segment, as opposed to outperformed vancomycin, showing eradication of fecal C. difficile at day three of treatment in 15 of 16 treated patients, versus vancomycin, which had eradication of C. difficile in just 10 of 14 treatments. Additional data from the Thais-to-Beak clinical trial show that Bezopilustat, but not vancomycin, consistently observed and allowed the regrowth of key duck bacterial species believed to confer health benefits, including prevention of recurrent C. difficile.

Section rate of 14, 3% to 14 patients whenever you're in fact.

On January 17, 2024, we announced positive comparative microbiology in microbiome data for the <unk> doesn't play basketball sat in CDI patients from the phase <unk> clinical trial segment.

And that is of course that outperformed vancomycin showing eradication of the sequel C has a seal ethane three of treatment in 15, or 16 treated patients versus vancomycin, which had eradication of C. Difficile and just kind of 14 treated patients.

Additional data from the phase <unk> clinical trial showed up as opposed to that but not a pack of lives and consistently is there and allowed regrows, but she got bacterial species, the least of it for health benefits, including prevention of recurrent C difficile infection.

David P. Luci: We anticipate that additional data from the secondary and exploratory endpoints will provide further favorable separation between these two therapeutic options in our phase three clinical trial program and ultimately in the marketplace if approved. Additional analyses regarding our secondary and exploratory endpoints will be forthcoming as data become available. We remain particularly excited about the dual impact of ibezafolstaz to treat acute C. difficile infection while appropriately managing the long-term care of each patient's microbiome, which we believe is exceptional for antibiotic therapy.

We anticipate that additional data from the secondary and exploratory end points will provide further favorable separation between these two therapeutic options in our phase III clinical trial program and ultimately in the marketplace if approved.

Additional analyses regarding secondary and exploratory end points will be forthcoming as data become available.

We remain particularly excited about the dual impact of base as opposed to that.

Treat acute C difficile infection, while appropriately managing our long term care of each patient's microbiome, which we believe is exceptional for antibiotics.

David P. Luci: Having robust preclinical, clinical, and manufacturing data to date, we submitted a formidable information package in early February to FDA along with a request for an end of phase two meeting, which was granted by FDA on Feb 26, and is scheduled to occur in April. We anticipate discussing our Phase 3 clinical trial mandate at this meeting and would anticipate documented meeting minutes from FDA sometime in the second quarter of this year. We also announced that the European Medicines Agency approved their application to be designated as a small to medium-sized enterprise, or SME, in Europe, which provides for certain benefits, including fee reductions and other support from the European Medicines Agency for seeking marketing authorization in Europe.

Having a robust preclinical clinical and manufacturing data to date, we submitted a form a formidable information package in early February due to FDA, along with our request for an end of phase II meeting, which was granted by FDA on February 26, and is scheduled to occur in April.

We anticipate discussing our phase III clinical trial data at this meeting and what it gives us a documented meeting minutes from FDA sometime in the second quarter of this year.

We also announced that the European Medicines agency approved our application to be designated as a small to medium sized enterprises or SME in Europe, which provides for certain benefits, including fee reductions and other support from the European medicines agency for seeking for seeking a marketing authorization in Europe.

David P. Luci: In November 2023, we filed an amendment to our shelf registration statement with the Securities and Exchange Commission and put up $17 million at the market or APM facility with Alliance Global Partners acting as sales agent to the company. Proceeds from the ATM will be used for general corporate purposes going forward, including our planned phase three clinical trial mandate. In October 2023, at ID Week, Dr. Kevin Gehry presented on our behalf, with selective spectrum of activity data from our Phase 2a clinical trial. Many of you may recall Dr. Gary is Professor and Chair, University of Houston College of Pharmacy, and the Principal Investigator for our Microbiome Aspects of the Adventive Full-Stack Clinical Trial Program.

In November 2023, we filed an amendment to our shelf registration statement with the Securities and Exchange Commission and put out the $17 million aftermarket or ATM facility with Alliance Global partners acting as a sales agent to the company.

Proceeds from the ATM will be used for general corporate purposes going forward, including a planned phase III clinical trial mandate.

In October 2023.

At I'd week, Dr. Kevin Gerry presented on our behalf.

With selective spectrum of activity data from a phase Iia clinical trial.

Many of you may recall, Dr. Gary as Professor and chair of the University of Houston College of Pharmacy, and the principal investigator for our microbiome aspects of the best of both of that clinical trial program.

David P. Luci: Also at ID Week, Bob DeLuccia, our Executive Chairman, presented our new class of novel DNA Pol III C inhibitors in our preclinical pipeline at the symposium entitled, New Antimicrobials in the Pipeline. Now, that's a lot of activity to digest, so I'll summarize further as to where we are today. As we speak, we're preparing to advance ibezapolis VAT into Phase III clinical trials and anticipate a favorable outcome from our upcoming FDA meeting regarding readiness to proceed and also to obtain agreement on the regulatory pathway for a new drug application filing for marketing approval in the U.S. once phase three is completed. We've also officially started the regulatory process in Europe and will add other territories to the list later this year. The phase three trials will include U.S. and international sites to enhance overall enrollment and to support international regulatory filings for marketing pools. This will save us a lot of time and money and allow us to expand our ultimate commercial reach.

Also at Ivy League, Bob Dilute Jr. Executive Chairman presented our new class of novel DNA <unk> inhibitors.

Our preclinical pipeline asset symposium entitled New Antimicrobials in the pipeline.

Now that's a lot of activity to digest, so I'll summarize further as to where we are today as we speak we're preparing to advance <unk> into phase III clinical trials and anticipate a favorable outcome from our upcoming FDA meeting regarding readiness to proceed and also to obtain agreement on the <unk>.

Regulatory pathway for a new drug application filing for marketing approval in the U S. Once phase three is completed.

We've also officially started the regulatory process in Europe.

Other territories to the less later this year.

The phase III trials will include the U S and international sites to enhance overall enrollment.

Support International regulatory filings for marketing approval. This will save US a lot of time and money and allow us to expand our ultimate commercial reach.

David P. Luci: To ensure Phase 3 clinical trial enrollment as quickly as possible, we're adding substantially more clinical trial sites, way above the number we use to conduct our U.S.-only Phase 2 trials. We're now getting our arms around the cost and timelines, but our plan is to conduct the required two phase three registration trials consecutively, not concurrently, given the size of our company and the need to use our financial resources most efficiently. The timeline for conducting our Phase 3 trial is not a concern since Adveza-Pulsa will have a rolling 10 years of regulatory exclusivity in the U.S. from the FDA approval date, with similar legislation in Europe, the U.K., and Japan.

To ensure phase III clinical trial and enrollment as quickly as possible, we're adding substantially more clinical trial sites way above the number we used to conduct a U S only phase II trials.

Now getting our arms around the cost and timelines, but our plan is to conduct the required two phase III registration trials consecutively now concurrently given the size of our company and need to use our financial resources most efficiently.

The timeline for our conduct of our phase III trials is not a concern since it is of course that will have a rolling 10 years of regulatory exclusivity in the U S from the FDA approval date with similar legislation in Europe, the UK and Japan.

Robert G. Shawah: We will continue to seek a strategic transaction for the company, including a potential partner for the further development and potential commercialization of Ibeza Polstat, as well as a potential sale, merger, third-party ex-U.S. territorial licensing arrangement, or other strategic transaction, alongside and in parallel with our preparation for a phase three clinical trial. At this time, we have no commitments from potential partners or others to provide the company with capital, but we started this initiative only recently, in February, after our Phase IIb data was released. So basically, we have two formidable plans A going forward, and we're equally excited about partnering M&A and phase three enrollment as next steps over the next 12 months. In a serious and potentially life-threatening infectious disease called C. difficile, that the U.S. CDC categorizes as an urgent threat, and there's a need for new classes of antibiotics for initial treatment that also has a low incidence of recurrence.

We will continue to see strategic a strategic transaction for the company, including a potential partner for the further development and potential commercialization of <unk>.

There's a pool set as well as a potential sale or merger third Party X U S territory, a licensing arrangement or other strategic transactions alongside it in parallel with our preparation for <unk>.

Phase III clinical trials.

At this time, we have no commitments from potential partners or others to provide the company with capital, but we started this initiative only recently in February after our phase II data was released.

So basically we have two formidable plants going.

Going forward and we're equally excited about partnering M&A and phase III enrollment as next steps over the next 12 months.

As we consistently reported that there is a force that continues to outperform in.

In a serious and potentially life threatening infectious.

Factious disease called C difficile.

The U S CDC categorizes as an urgent threat.

There's a need for new classes of antibiotics, where initial treatment. It also has a low incidence of recurrence.

Robert G. Shawah: That's a post that also has FDA fast track designation for the treatment of C. difficile infection. Additionally, we believe IbizaPulseTat, if approved, could make a favorable impact by reducing the cost burden of current C. difficile infections on our U.S. healthcare system, which is estimated at $4.7 billion annually. We do believe the best is yet to come. And now, back to our CFO Rob Shawah to guide you through the highlights of our financial results for the fourth quarter and full year 2023. Rob?

I suppose that also has FDA fast track designation for treatment of C difficile infection.

Additionally, we believe it does it pulls that if approved could make a favorable impact by reducing the cost burden of current C. Difficile infection, and our U S health care system, which is estimated at $4 $7 billion annually.

We do believe the best is yet to come.

And now back to our CFO, Rob shallow to guide you through the highlights of our financial results for the fourth quarter and full year 2023.

Rod.

Robert G. Shawah: Thanks, Dave. Our financial results for the fourth quarter and 12 months ended December 31, 2023 were included in our press release issued earlier this morning. The company ended the year with cash totaling $7.5 million compared to $9.1 million as of December 31, 2022.

Thanks, Dave.

Our financial results for the fourth quarter and 12 months ended December 31, 2023 were included in our press release issued earlier this morning.

The company ended the year with cash totaling $7 $5 million.

It's a $9 $1 million as of December 31, 2022.

Robert G. Shawah: Subsequent to year-end, the company sold an additional 1,121,793 shares under its ATM financing program with gross proceeds of approximately $4.5 million. Research and development expenses for the three months ended December 31, 2023 were $1.9 million, compared to $1.4 million for the three months ended December 31, 2022. The increase was due to the timing of Phase IIb trial-related costs and an increase in consulting costs. For the year ended December 31, 2023, research and development expenses were $6 million versus $4.8 million for the year ended December 31, 2022, the increase due primarily to Phase 2B costs and an increase in consulting costs. General Administrative Expenses for the three months ended December 31, 2022 were $3.2 million, compared to $1.8 million for the three months ended December 31, 2022.

Subsequent to year end the company sold an additional 1 million and 121793 shares under its ATM financing program with gross proceeds of approximately $4 $5 million.

Research and development expenses for the three months ended December 31, 2023 were $1 $9 million compared to $1 $4 million for three months ended December 31 2022.

The increase was due to timing of phase two b trial related costs and an increase in consulting costs.

For the year ended December 31, 2023 research and development expenses were $6 million, which is $4 $8 million for the year ended December 31 2022.

The increase is due primarily to phase two b costs and increased consulting costs.

General and administrative expenses for three months ended December 31, $2023 2 million compared to $1 8 million for three months ended December 31 2022.

Robert G. Shawah: The increase was due primarily to $800,000 increase in professional fees, a $.1 million increase in share-based compensation, and a $.3 million increase in employee compensation. For the year ended December 31, 2023, general administrative expenses were $8.5 million versus $7.3 million for the year ended December 31, 2022. The amounts reflect an increase in professional fees of $0.5 million, an increase of $0.3 million in share-based compensation, and an increase of $0.3 million in employee compensation. The company reported a net loss of $5.1 million, or $0.37 per diluted share, for the three months ended December 31, 2023, compared to a net loss of $3.3 million, or $0.28 per diluted share, for the three months ended December 31, 2022, and a net loss of $14.6 million, or $1.15, for the year ended December 31, 2023, compared to a net loss of $12.1 million, or $1.12 The company had 14,468,229 shares outstanding as of December 31, 2023.

The increase was due primarily.

$800000 increase in professional fees appoint $1 million increase in share based compensation and a point $3 million increase in employee compensation costs.

For the year ended December 31, 2023 general administrative expenses.

Were $8 $5 million versus $7 $3 million for the year ended December 31 2022.

The amounts reflect an increase in professional fees of <unk> $5 million.

An increase of <unk> $3 million and share based compensation.

And it increased to a point $3 million in employee compensation costs.

The company reported a net loss of $5 $1 million or <unk> 37 cents per diluted share for the three months ended December 31 2020 through.

Compared to a net loss of $3 3 million or 28 cents per diluted share for the three months ended December 31 2022.

And a net loss of $14 6 million or $1.15 per share for the year ended December 31, 2023, compared to a net loss of $12 $1 million or $1 12 per diluted share for the year ended December 31 2022.

The reasons previously mentioned.

The company had 14 million 468229 shares outstanding.

As of December 31, 2023.

With that I'll turn the call back over to Dave.

David P. Luci: With that, I'll turn the call back over to Dave. Thanks, Rob, and to all of you for joining us today. I'll now ask Bob DeLuccia, our Executive Chairman, to provide his perspective, given that he manages our R&D program. And when Bob is finished, Operator, please open the call to questions. Thanks Dave and Rob for updating our stakeholders and thanks to all for the continuing support as we advance as it enters phase three, phase three clinical trials. This is a very exciting time, and really, it's the final step to commercialize Ibiza Polstat.

Thanks Rod.

And so all of you for joining us today I'll now ask Bob to Luciano Executive Chairman to provide his perspective, given bought manages our R&D program and when Bob has finished operator, please open the call for questions.

Thanks, Dave and Rob for updating our stakeholders and thanks to all for their continuing support as we advance <unk> into phase III truck phase III clinical trials is a very exciting time and really it's the final step to commercialize that as opposed to that.

For patients in need of a promising new antibiotic with a novel bacteria silent mechanism of action to treat CDI and many of you will remember that approximately 30000 people die each year in the U S alone from CDI and the annual incidence is more <unk>.

Robert J. DeLuccia: For more information, visit www.aclu.org or www.acurxpharmaceuticals.com. The bottom line here is that if the outcome of our Phase 3 trials is consistent with our Phase 2 experience, we'll have an approvable new drug in our system. The data are solid, the market is large, and our manufacturing cost is low. We do have a robust preclinical, clinical microbiome safety, and CMT program that we've submitted to the FDA, and as Dave mentioned, they've determined it acceptable to grant us an end-of-phase-II meeting next month. Discuss trial design, patient enrollment targets, and confirm our readiness to go forward. So, to complete our Phase 2, and international Phase 3 trials, which will be done sequentially, as Dave mentioned, and as quickly as possible, we've already initiated steps to advance screening, and cover sites in about 17 other countries. Central, Northern, and Western Europe, totaling about 100 sites, which we believe will accelerate overall enrollment.

About half a million per year in the United States, but the bottom line here is that if the outcome of our phase three trials are consistent with our phase two experience, we will have an approvable new drug in our hands.

The data are solid the market is large and our manufacturing cost is low.

We do have a robust preclinical clinical and microbiome safety and CMC evidence package that we submitted to the FDA and as Dave mentioned, they've determined that acceptable to grant US an end of phase two meeting next month to discuss trial design patient enrollment targets.

And to confirm our readiness to go forward.

So to complete our phase III International Phase III trials, which will be down sequentially as Dave mentioned and as quickly as possible, we've already initiated steps to advance screen potential clinical trial sites.

Which in addition to North America will cover sites and about 17 other countries, including several in eastern central Northern and Western Europe totaling about 100 sites.

Which we believe will accelerate overall enrollment.

Robert J. DeLuccia: We'll also be including several high-enrolling trial sites from the Fast Enrolling Summit Phase III CDI trial, which was conducted during the height of COVID-19, in addition to the global scope of the program compared to phase two and the strength of our phase two data. The Phase 3 protocol will allow more flexibility for inclusion and exclusion criteria as a standard for CDI pivotal registration trials, so we anticipate faster enrollment once we have results from our FDA meeting and documented meeting minutes from the FDA. Our next priority will be to submit our plans to the European Commission and the Medicines Agency, or EMA, for conducting Phase III clinical trials. So, if approved, we'll have the first new class of antibiotics approved by FDA in over 30 years, with only confirmatory phase 3 trials between now and market introduction.

We'll also be including several high enrolling trial site.

You're asking rolling summit Phase III CDI trial, which was conducted during the height of COVID-19.

In addition to global scope of the program compared to phase two and the strength of our phase II data.

The phase III protocol will allow more flexibility for inclusion and exclusion criteria as the standard for CVI pivotal registration trials, so we anticipate faster enrollment.

And then once we have results from our FDA meeting and document the meeting minutes from the FDA. Our next priority will be this just made our plans to the European medicines agency or EMA.

For conducting phase III clinical trials in Europe.

So if approved we will have the first new class of antibiotics approved by FDA in over 30 years with only.

Confirmatory phase III trials between now and market introduction.

Robert J. DeLuccia: There's a post that, as Dave mentioned, is fast-tracked by the FDA, fully patented and with regulatory exclusivity 10 years post market introduction in the U.S. And we have similar opportunities for regulatory exclusivity in other geographies to pursue with the appropriate... And also with recent focus on minimizing effects on the microbiome to lower recurrence of infection, stand out from other antibiotics since we've shown no reinfection in phase 2 patients, who were initially cured of their infection.

There's a pulse that as Dave mentioned this this fast track by FDA.

It's fully patented and with regulatory exclusivity 10 years post market introduction in the U S and similar opportunities for regulatory exclusivity in other geographies to pursue at the appropriate time.

And also with recent recent focus on minimizing effects on the microbiome to lower recurrence of infection, we stand out from other antibiotics since we've shown no reinfection in phase II patients who were initially cured of their infection.

Operator: So, in my over 50 years of experience in antibiotic development and marketing, I think I've got a great rearview mirror and a clear vision to say that we have a winner here for patients with CDI and, in general, for better public health, as well as for our shareholders. Thanks for letting me comment, Dave. Thank you, Bob. Melissa, we're now ready to go to Q&A. Thank you. If you'd like to ask a question, please press star 1 on your telephone keypad. A confirmation tone will indicate your line is in the question queue.

So in my over 50 years of experience in antibiotic development and marketing I think I've got a great rearview mirror and a clear vision to say that we have a winner here for patients with CDI and in general if a better public health as well as for our shareholders. Thanks for thanks for let me comment there.

Thank you, Bob and Melissa we're now ready to go to Q&A.

Thank you if you'd like to ask a question. Please press star one on your telephone keypad, a confirmation tone will indicate your line is in the question. Kim You May press star two if you'd like to remove your question from the queue.

Operator: You may press star 2 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 star 2. Our first question comes from the line of Jason McCarthy with Maxim Group. Please proceed with your question. Hey guys, this is Michael Okunewitch on the line for Jason.

Participants using speaker equipment, it may be necessary to pick up your handset before pressing the star keys.

Our first question comes from the line of Jason Mccarthy with Maxim Group. Please proceed with your question.

Hey, guys. This is Michael <unk> on the line for Jason. Thank you for taking my questions today.

Michael Okunewitch: Thank you for taking my questions today. Hi Michael. Yeah, so I guess just to start off, I'd like to see if you could give an idea of what sort of timelines you're expecting between getting those meeting minutes back from the FDA and actually launching the first of those phase three studies. So we think that we will be ready to enroll the first patient in for international phase three in the fourth quarter of this year. All right, thank you. And then, regarding the international component of the study, could you talk a little bit more about the path to actually getting those sites online? And then is this something that you would look to have in place ahead of the launch? Or would you start with, you know, what you have when you're ready to actually enroll the study and then add these international sites as they are approved?

Hi, Michael Thank you.

Yeah.

I guess just to start off I'd like to see if you could give an idea of what sort of timeline, you're expecting between getting those meeting minutes back from the FDA and actually launching the first of those phase III studies.

So we think that we will be ready to enroll.

Our first patient in for the international Phase III.

In the fourth quarter of this year.

Alright, Thank you and then I guess regarding the.

The international component to the study could you talk a little bit more about the path to actually getting those sites online and then is this something that you would look to have in place ahead of the launch or would you start with you know what you have when you are ready to actually enroll the study and then layer in these international sites as they were approved.

Sure.

David P. Luci: Well, it will be a little bit of both. So, we have a number of sites already, you know, kind of ready to go from the international list. There won't be any holdup from the international aspect of it. We actually have a consultant who is extremely familiar with the Phase 3 C. diff international trials who's been guiding us in this regard. But yes, clearly, when our manufactured product is ready, we'll be ready to go with a large wedge on at least a hundred sites. All right, thank you. And then one last one for me, and I'll hop back in the queue.

Well it it will be a little bit of both.

So we have a number of the sites already.

Kind of ready to go from the International list, they're there won't be any holdup for from the international aspect of it.

We actually have a consultant who is extremely familiar with Citi.

Today's III C Diff international trials.

He has been a guiding us in this regard.

But yes, clearly when our manufactured product is ready.

We'll be ready to go with you.

Large wedge at the very least of the 100 sites.

Alright. Thank you and then one last one from me and I'll hop back in the queue.

Yeah.

David P. Luci: With regard to securing international partnerships, do you think this is something with your existing body of data that is compelling enough that you could really progress those conversations now and get a partner, or would you expect it to be more after you get that first slot of phase three data? I would expect that the prime time for us to find a European partner or a Japanese partner would be when we start enrolling the first of the two phase three trials. Once we have the Phase 3 trial mandate completed and we're ready to file a new drug application, If we hadn't had a partnership by then, I think it would probably not occur until a year after the market introduction because folks who want to see how well we do. So yeah, I think that the time is right, right now.

With regards to securing international partnerships do you think this is something with your existing body of data that is compelling enough that you could really progressed those conversations now and get a partner or would you expect it to be more after you get the first lot of phase III data.

No I wouldn't expect that the prime time.

For us to find.

I'll say, a European partner or Japanese partner would be.

When we start enrolling the first of the two phase III trials.

Once we have the phase III trial mandate completed and we're ready to side or the Viale, a new drug application.

If we haven't had a partnership by then I think it would probably not occur until a year after the market the market introduction.

He is folks who want to see how well we do.

So yes, I think the time is ripe right now.

David P. Luci: Thank you. It's great to hear from you. You know, I'll make one additional comment on the territorial partnerships, you know, to carry Michael's question response a little bit further. You know, as we look at strategic alternatives, you know, there's M&A full stop, and there's territorial licensing and co-development agreements that I've interviewed for in the past. And, you know, with our share price being where it is, the territorial licensing is a bit easier to consummate because it's all about the intrinsic value of your drug, as opposed to M&A, which, you know, you can't, in my view, wholly divorce yourself of your NASDAQ share price.

Thank you great to hear.

I'll make one additional comment on the AR and the territorial partnerships.

You know Kevin Michaels question, a response a little bit further.

As we look at our strategic alternatives.

There is M&A full stop and theirs territorial licensing and co development agreements.

We entered into in the past.

And you know.

With our share price being where it is.

It's.

The territorial licensing is a bit.

Easier to consummate.

Because it's all about the intrinsic value of your drug as opposed to M&A.

Which in my view wholly divorced yourself of your NASDAQ share price.

David P. Luci: So, it may be a more attractive option for our Board of Directors, you know, but we'll see; we'll see what the term sheets present themselves. Thank you. Looking forward to any updates. Thank you, Michael.

So it may be.

A more attractive option for our board of directors.

But we'll see we'll see what the term sheets present themselves.

Thank you looking forward to any updates.

Thank you Michael.

Operator: Thank you. Our next question comes from the line of James Molloy with Alliance Global Partners. Please proceed with your question. Hey, how are you doing, David?

Thank you. Our next question comes from the line of James Molloy with Alliance Global Partners. Please proceed with your question.

Good morning, again, and thanks for taking my questions Hey, how are you doing David Thank you very much for taking the questions.

James Francis Molloy: Thank you very much for taking the question. Excellent. The Phase III trials, I know that obviously there is a lot to go here, but can you walk through the expectations which we should expect to see coming out of the end of Phase II, and then the trial designed to sort of length of time to run the two, is about two years start to finish for the Phase IIb. I know we're dealing with COVID then as well.

Excellent that's it.

The the phase III trials I know, there's obviously a lot a lot to go here, but can you walk through them.

The expectation was we would expect to see coming out of the end of phase two.

Then.

The trial designs or sort of the length of time to run. The two is about two years start to finish.

To be I know, we're dealing with Covid, then as well as.

David P. Luci: Does that seem reasonable to run these two Phase IIIs from start to finish? You know, well, the two phase threes, so we're going to address one phase three. And then the idea would be to either do a strategic transaction after that first phase three, or with positive data on the first phase three, you know, if it's the same or consistent with our phase two, get a share price rise and then raise capital for the second phase. So we're targeting a year-and-a-half from start to finish for the first phase 3, and that would have us completing the first phase 3 in the second quarter of 26. Now, I can tell you that, you know, we spent a lot of time looking at the Summit Therapeutics experience, and, you know, Summit enrolled in the teeth of COVID 750 or so patients in about two years' time, largely in Eastern Europe, where, you know, the behavior patterns weren't dramatically changed, apparently, like they were here in the US. So, you know, that's a public list on clinchiles

Does that seem reasonable to run these two phase threes from a start to finish.

Yeah.

Well.

The two phase III, so we're going to address one phase III.

And then the idea would be to you.

Either do a strategic transaction after that first phase III or with positive data on the first phase III.

It's the same or consistent with our phase two data.

Share price rise and then raised capital for the second phase III.

So we're targeting a year and a half from start to finish.

For the first phase III.

And that would have us completing the first phase III in the second quarter of 2006.

Now I can tell you that we.

You know we spent a lot of time looking at the summit therapeutics experience.

And you know summit enrolled in the teeth of Covid.

150, or so patients and about two years' time.

Largely in eastern Europe, where the behavior patterns were dramatically changed apparently like they were here in the U S.

So.

That's a public listing on the trials that drugs. So we were able to see exactly the heat patterns from from their enrollment so that's gone.

David P. Luci: So we were able to see exactly, you know, the heat patterns from their enrollment. So that's gone a long way to helping us get comfortable with fixing the enrollment issues we had during COVID with our U.S. only trial. Okay, my apologies. I thought I'd heard you say earlier in the call that you were going to run the two trials at the same time. I was going to serve that during back to back.

So on a long way to helping us get comfortable with a fixing the enrollment issues, we add dirty coated with our U S only trial.

Yeah.

Okay. My apologies I thought I heard you say earlier in the call that you got to run the two trials at the same time.

Obviously misheard that journey back back to back.

David P. Luci: Oh, yeah, no, no, you know, our plan is to do them consecutively instead of concurrently, for the financial reasons that we discussed. But if we get a partnership, say, a European licensing agreement, you know, and that brings in enough money to call an audible along the way, and at that point, then we would certainly start phase three accordingly. I understand. Thank you very much for taking the time to answer the question. Thank you, Jim. Thank you. Our next question comes from the line of Ed Arce with H.C. Wainwright.

No.

Our going in plan is to do them consecutively instead of concurrently.

For the financial reasons that we discussed.

If we hit our partnership say, our European licensing agreement.

And that brings in enough money to call an audible along the way and at that point, then we would certainly start the second phase III Accordingly.

Understood. Thank you very much for taking the questions.

Thank you Jan.

Yes.

Thank you, ladies and gentlemen, as a reminder, if you'd like to ask a question. Please press star one on your telephone keypad.

Ed Arce: Please proceed with your question. Great. Thanks for taking my questions, Dave, Rob, and Bob. It's good to hear you on the phone, on the call.

Our next question comes from the line of Ed Arce with H C. Wainwright. Please proceed with your question.

Great. Thanks for taking my questions, Dave Robin Bob It's good to hear you on the phone.

David P. Luci: Great. Thanks, sir. Likewise.

On the call great nice to hear you bet. Thanks.

David P. Luci: So, a couple of questions, firstly, on the end of phase 2 next month, and I apologize; I joined late, so maybe you went over this already, but wanted to make sure to review sort of the key objectives. In particular, what do you not yet have agreement with the agency on that you would seek to get agreement on next month in that meeting? And then secondly, I think you made mention of a wider exclusion criteria for phase three relative to the prior phase two. And so I just wanted to get a little more clarity on that. In particular, you know, but with a view to concerns there might be around the risk that, you know, could change the sort of design of the trial, and there could be, you know, some disruption from a slightly different patient population. Thanks so much. Thank you, Ed.

Likewise.

So a couple for me firstly on the end of Phase two next month.

And I apologize I joined late so maybe you went over this already but.

Wanted to make sure to review sort of the key objectives in particular.

What do you not have agreement with the agency yet on.

That you would seek to get agreement on next month in that meeting.

And then secondly, I think you made mention of a wider.

Inclusion exclusion criteria for the phase III relative to the prior phase two.

And.

I just wanted to get a little more clarity on that in particular.

Okay.

You too.

Concerns there might be around the risk.

That.

It could change the sort of design of the trial and there could be some.

Disruption from from a slightly different patient population. Thanks.

Thanks, so much.

Thank you Ed.

David P. Luci: I'll answer the first part of your question and then ask Bob to provide a response to the inclusion and exclusion criteria part of your question. So for the first part of your question, what we hope to agree on with the FDA is the overall protocol design for our phase three trial, including the number of patients to be enrolled, and the notion that we're gonna have a vacumycin control arm like we had in our phase 2B. Largely, the trial design is 90 plus percent of what the trial design was for our phase 2B. So we don't expect a lot of drama, but it's a necessary step in order to, you know, kind of, be allowed to go into phase three. So we're looking forward to it as a value inflection point that we have to get through.

I'll answer the first part of your question and then ask Bob to.

To provide a response for the inclusion and exclusion criteria part of your question.

So for the first part of your question, what we hope to agree on what the FDA is the overall protocol design for our phase III trial, including the number of patients to be enrolled.

Notion that we're gonna have a vancomycin control arm like we had in our phase II B.

Largely the trial design is yeah, 90, plus percent of what the trial design was for phase two b. So we don't expect a real lot of drama.

But it's a necessary step in order to kind of.

You're allowed to go into phase III. So we're looking forward to it as a value inflection point that we have to get through them.

David P. Luci: Bob, did you wanna add some comments on the inclusion and exclusion criteria? Yeah, I think really two things which are standard fare for going forward in phase three are that we'll have additional patients beyond mild and moderate that are included in the trial. So this is not severe CDI, but a little bit more than a moderate, according to the IDSA.

Bob did you want to add some comments on the inclusion and exclusion criteria.

Yeah, I think really two things, which is standard fare for going forward in phase three is that we will have additional patients beyond mild and moderate that are included in the trial. So this is not severe.

CDI, but a little bit.

More than it was at a moderate according to the Esa excuse me.

Robert J. DeLuccia: According to the IDSA criteria for patient entry into a trial in the study, So we've already submitted a framework to the FDA in the meeting package. It's very straightforward. I'd even say a higher percentage than Dave said at 90.

According to the idea.

Our criteria for patient entry.

Into a trial in this study so we've already submitted a framework to the FDA in the meeting package, it's very straightforward I'd, even say higher percentage and Dave said at 90.

Robert J. DeLuccia: We're pretty much there with the design, same design basically as phase two and very standard according to the FDA guidance from October. I believe it is as to what needs to be included in the Phase III clinical trial. So we'll be discussing final numbers of patients, as I said before, and the statistical analysis plan will be finalized at that update. www.AcurxPharmaceuticals.com Yeah, that's helpful.

We're pretty much there with the design. It's it's the same design basically is phase two and very standard. According to the FDA guidance from October two.

2022, I believe it is as to what needs to be included.

The phase III clinical trials.

So we will be discussing final numbers of patients as I said before and statistical.

Analysis plan.

It will be finalized at the upcoming FDA meeting as well.

Anything else does that answer your question.

Yeah.

Robert J. DeLuccia: Thanks so much. Thank you. Ladies and gentlemen, that concludes our question and answer session and thus concludes our call today. We thank you for your interest and participation. You may now disconnect your line.

Yeah. That's helpful. Thanks, so much.

Thank you, ladies and gentlemen that concludes our question and answer session and thus concludes our call today. We thank you for your interest and participation you may now disconnect your lines.