Acurx Pharmaceuticals - Q3 2023

Transcript

Operator (participant)

Ladies and gentlemen, good morning, and welcome to the Acurx Pharmaceuticals third quarter 2023 earnings conference call. At this time, all participants are in a listen-only mode. A brief question-and-answer session will follow the formal presentation. If anyone should require operator assistance during the conference, please press star and 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. Please go ahead.

Rob Shawah (CFO)

Thank you, Ryan. Good morning, and welcome to our call. This morning, we issued a press release providing financial results and company highlights for the third quarter of 2023, which is available on our website at acurxpharma.com. Joining me today is Dave Luci, President and CEO of Acurx, who will give a corporate update and outlook, and Bob DeLuccia, our Executive Chairman, who will provide his perspective as the manager of our development programs, including the phase II clinical trial. After Dave's comments, I'll provide some highlights of the financials for the quarter ended September 30th, 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. Investors should consider these risks and other information described in our filings made with the Securities and Exchange Commission, including our quarterly report on Form 10-Q, which we filed yesterday, Monday, November 13th, 2023. 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, November 14th, 2023.

Acurx undertakes no obligation to revise or update any forward-looking statements to reflect events or circumstances after the date and time of this conference call. I'll now turn the call over to Dave Luci. Dave?

Dave Luci (President and CEO)

Thanks, Rob. Good morning, everyone, and thanks for joining us to to review our financial results for the third quarter and also to cover some exciting recent updates. Then we'd be pleased to take any questions. On October 2nd, 2023, we ended enrollment in our phase II-B clinical trial of ibezapolstat, our lead antibiotic candidate for the treatment of patients with C. difficile infection or CDI. On November 2nd, 2023, we reported top-line data from the phase II clinical trial, including the ibezapolstat clinical cure rate at end of treatment, or EOT, of 96%, 25 out of 26 patients, including 100% in phase II-A, 10 for 10, and 94% in phase II-B, 15 for 16, as well as the cure rate for oral vancomycin at EOT of 100%, 14 of 14.

No safety concerns were reported in either arm of the phase II-B clinical trial or in the phase II-B open label trial. Based on the phase II data, in consultation with our scientific advisors, we determined that clear evidence of clinical cure has been established with ibezapolstat, and it is clinically comparable to vancomycin. Ibezapolstat will now move forward to phase III clinical trials. Further data will be provided when available on all of the secondary and exploratory endpoints in the phase II-B trial, including sustained clinical cure, extended clinical cure up to 94 days, and the comparative impact on the microbiome. We anticipate that these secondary and exploratory endpoints will provide clear separation between these two therapeutic options, and all of these endpoints will be disclosed when available over the next 90 days.

The phase II-B trial was originally designed to be a non-inferiority trial and later amended to include an interim efficacy analysis with a review by an Independent Data Monitoring Committee, or IDMC. The decision to end the trial early, based on the blinded clinical observations, obviated the need for an interim analysis, the need for the IDMC review, and the non-inferiority assessment. The company determined, in consultation with its clinical and statistical experts, that presenting clinical cure rates for the primary efficacy endpoint is the most appropriate representation for the clinical activity of ibezapolstat in treating C. diff infection. We remain particularly excited about the dual impact of ibezapolstat to treat the acute C. diff infection while appropriately managing the long-term care of each patient's microbiome, which we believe is exceptional for antibiotic therapy.

Other key highlights from the third quarter, or in some cases shortly thereafter, include the following: The World Antimicrobial Resistance Congress convened its annual meeting in Philadelphia in September 2023, where experts in the field from both the public and private sectors weighed in on the latest innovations to address antimicrobial resistance. Our Executive Chairman with us today, Bob DeLuccia, presented an update entitled Novel DNA pol IIIC Inhibitors for Gram-Positive Bacterial Infections, Preparing for the Next Pandemic. This presentation, as well as the others that I'll describe, is available on our website at acurxpharmaceuticals.com. At IDWeek, which convened in Boston, October 11-15, Acurx was featured at two scheduled events. First, an oral presentation was provided by Dr.

Kevin Garey, Professor and Chair, University of Houston College of Pharmacy, and the principal investigator for microbiome aspects of our ibezapolstat trial program, entitled, Elucidating the Gram-Positive Selective Spectrum Activity of Ibezapolstat, Secondary Analysis from the phase II-A trial. Secondly, at IDWeek, Acurx presented at the symposium entitled New Antimicrobials in the Pipeline. At the symposium, Acurx presentation was entitled Novel DNA pol IIIC Inhibitors for Gram-Positive Bacterial Infections. Next up was the ClostPath meeting, the International Conference on Molecular Biology and Pathogenesis of Clostridia, at which there were three scientific posters presented during the conference in Banff, Canada, from September 19 to 23. We provided new information supporting ibezapolstat's unique pharmacologic profile. The first of the three was entitled, Ibezapolstat modulates Clostridioides difficile virulence factors in vitro, showed ibezapolstat reduces toxin production by C. diff bacteria. The second, entitled C.

diff in Vitro Biofilm Studies of Ibezapolstat and Comparator Antibiotics showed ibezapolstat was as effective as the currently used anti-C. diff antibiotics, fidaxomicin, vancomycin, and metronidazole, reducing biofilm-embedded C. difficile. The third, entitled Metagenomic Evaluation of Ibezapolstat Compared to Other Anti-C. diff Agents, showed ibezapolstat and fidaxomicin both caused favorable proportional increases in Bacteroidetes, but distinct from vancomycin and metronidazole, which caused unfavorable proportional increases in Proteobacteria. All the presentations, again, are available on our website. And now back to our CFO, Rob Shawah, to guide you through the highlights of our financial results for the third quarter of 2023. Rob?

Rob Shawah (CFO)

Thanks, Dave. Our financial results for the third quarter ended September 30th, 2023, were included in our press release issued earlier this morning. The company ended the third quarter with cash totaling $7.1 million, compared to $9.1 million as of December 31, 2022. I'll also note that subsequent to the quarter, to the September 30, we did receive $2.2 million in cash from warrant conversions in October of 2023. Research and development expenses for the three months ended September 30th, 2023, were $1.3 million, compared to $1.6 million for the three months ended September 30, 2022. The decrease was due to the timing of phase II-B trial-related costs.

For the nine months ended September 30th, 2023, research and development expenses were $4.1 million versus $3.3 million for the nine months ended September 30, 2022. The increase is due primarily to phase II-B trial-related costs and an increase in consulting costs. General and administrative expenses for the three months ended September 30th, 2023, were $1.8 million, compared to $2 million for the three months ended September 30th, 2022. The decrease was due primarily to a $0.2 million decrease in professional fees. For the nine months ended September 30th, 2023, general and administrative expenses were $5.4 million versus $5.5 million for the nine months ended September 30th, 2022.

The amounts reflect a decrease in professional fees of $0.3 million, offset by an increase of $0.2 million in share-based compensation. The company reported a net loss of $3.1 million, or $0.24 per diluted share, for the three months ended September 30th, 2023, compared to a net loss of $3.5 million, or $0.32 per diluted share, for the three months ended September 30, 2022. A net loss of $9.5 million or $0.77 per share for the nine months ended September 30, 2023, compared to a net loss of $8.8 million, or $0.84 per diluted share for the nine months ended September 30, 2022, all for the reasons previously mentioned.

The company had 13,005,128 shares outstanding as of September 30th, 2023. With that, I'll turn the call back over to Dave. Dave?

Dave Luci (President and CEO)

Thanks, Rob, and to all of you joining us today. We outlined advances in several areas that we believe will spur continued momentum and growth to build on our strong fundamentals. We, we look forward to sustaining this momentum, even during these challenging times, and sharing future updates in the coming months. Now, in advance of our customary Q&A, I'll ask my Co-founder and Executive Chairman, Bob DeLuccia, to provide his perspective, given Bob manages our research and development programs, including the recently completed phase II clinical trial. Bob?

Bob DeLuccia (Executive Chairman)

Thanks, Dave, and thanks for updating our stakeholders on our recent progress, and thanks to all-

... for your continuing support to reach this important clinical development milestone, which takes ibezapolstat one step closer to commercialization for CDI patients in need of a promising new antibiotic with a novel bactericidal mechanism of action. This is especially important in this age of emerging antimicrobial resistance to the currently used antibiotics. From my perspective, we now have robust scientific evidence to present a strong data package to FDA for an End-of-Phase 2 meeting. The outcome of this meeting will confirm our readiness to advance to phase III clinical trials, with specifics on trial design and patient enrollment targets. At the same time, we'll submit our plans to the European Medicines Agency for conducting phase III clinical trials outside the United States, and we expect to have their guidance around mid-year next year.

Bottom line is, I think we have a new antibiotic, which is first in a new class and fast-tracked by the FDA. It's fully patented. It has regulatory exclusivity, 10 years post-market introduction in the U.S. as well. It works extremely well. It's clinically comparable to the standard of care after 10 days of treatment in a serious and potentially life-threatening infection that demands antibiotic treatment. From what we've seen so far, we expect to further demonstrate favorable effects on the microbiome and less recurrence of infection. It's also very well tolerated and efficient to manufacture, so we can be cost competitive in the marketplace. Now, since we'll be the only C. diff antibiotic beginning phase III next year, assuming success, we'll be next up at bat for approval and market introduction in the U.S. and countries outside the United States.

In my over 50 years' experience in antibiotic development and marketing, I think I've got a good rearview mirror that gives me a clear vision and a pathway forward to deliver a winner here, not only for patients with C. diff infection, but in general for better public health and, of course, for our shareholders. In my opinion, simply put, ibezapolstat kills the bug and preserves, and preserves the microbiome. And back to you, Dave.

Dave Luci (President and CEO)

Thank you, Bob. I'll now open the call for questions. Operator?

Operator (participant)

Thank you. Ladies and gentlemen, we will now be conducting a question-and-answer session. If you would like to ask a question, please press star and one on your telephone keypad. A confirmation tone will indicate your line is in the question queue. You may press star and two if you'd like to remove your question from the queue. For participants using speaker equipment, it may be necessary to pick up your handset before pressing the star keys. Ladies and gentlemen, we will wait for a moment while we poll for questions. Our first question is from Jason McCarthy with Maxim Group. Please go ahead.

Michael Okunewitch (Senior Analyst of Biotechnology)

Hey, guys. How's it going? This is Michael Okunewitch on the line for Jason, and first off, I'd like to congratulate you on the progress.

Dave Luci (President and CEO)

Thank you, Michael.

Michael Okunewitch (Senior Analyst of Biotechnology)

So I guess to start off, I'd like to see if you give us a bit more of an idea of what you're thinking ahead of the End-of-Phase 2 meeting, in terms of what a phase III program could look like, in terms of size and scope, potential cost, and then also if you would still be targeting non-inferiority as a primary endpoint. Can you just give me your thoughts on that?

Dave Luci (President and CEO)

Sure. And yes, we would still be targeting non-inferiority to the control arm, which would be oral vancomycin, much like Summit did most recently in its effort to get an antibiotic approved to treat C. diff. What we're looking at is, we're looking at two clinical trials in phase III, two registration trials. We're considering, and all of this is preliminary, as you know, but we're considering an imbalanced approach pursuant to which we would have fewer patients in the first trial and more patients in the second trial, so that we could potentially raise money to fund the smaller first trial.

And with continued good data in hand, non-inferiority, in this case, for phase III registration trial, we would hope to see an uptick in our share price and use that uptick to raise money for the second trial. Keeping in mind that this sequential approach is, you know, very possible for us because we have 10 years of market exclusivity with our new molecular entity status and QIDP. So I think that's what we would do. I think the first trial, you know, I think we would, you know, ballpark figures, we would try to have a two-to-one randomization, potentially and preliminarily, if that gets through our science team and the FDA, and it might look something like 133 patients on ibezapolstat and 66 on oral vancomycin.

So it would be a much more discreet trial than I think a lot of people are thinking. So to pay for it won't, for a small company, won't be that challenging.

Michael Okunewitch (Senior Analyst of Biotechnology)

All right. Thank you for that. Then, one more from me, and I'll hop in the queue. Just as we're getting up to those, secondary analyses, could you talk a little bit about what you're looking for specifically in terms of clinically relevant separation from vanco? What kind of thresholds you would need to reach in those secondary endpoints?

Dave Luci (President and CEO)

So, you know, we think that the microbiome advantage is the key advantage, because that's the thing that most antibiotics don't do.

... So if we can address the acute infection while at the same time fully restoring a healthy microbiome to baseline, yeah, that's something which I don't know of any other antibiotic that's able to do that. We're still studying the mechanism of action to see how that's done, but I think that provides clear separation by itself. We're also the only folks that have gone out formally 94 days for antibiotics in C. diff, at least, to see that there are no reinfections that far out. So I'm particularly excited about that 94-day out data to see in a subset of patients how many patients of ours are reinfections 94 days out compared to vancomycin. So those are two real exciting pieces.

What we're gonna do, since all of this, all of the secondary and exploratory endpoints are so material, you know, from a corporate level perspective, and we don't want to be holding material, non-public information, for any sort of period of time, you know, for the SEC purpose. So we'll be getting the data out as it comes in on the sustained clinical cure, the extended clinical cure, and of course, the microbiome comparison. We won't wait for it to be all together. We'll get it out as we receive it.

Michael Okunewitch (Senior Analyst of Biotechnology)

All right. Thank you very much.

Dave Luci (President and CEO)

Thank you, Michael.

Operator (participant)

Thank you. Our next question is from Ed Arce with H.C. Wainwright. Please go ahead.

Thomas Yip (Research Associate)

Hi. Good morning, everyone. This is Thomas Yip, and a clear question for Ed. Thank you for taking my questions. Perhaps first question, I believe you touched on it a little bit. When can we expect to see more phase II data? Will this be in a publication or will this be around major medical conference?

Dave Luci (President and CEO)

I'm sorry, when can you expect to see the secondary endpoint information?

Thomas Yip (Research Associate)

Yes, that's right. Just additional phase II data, additional analysis.

Dave Luci (President and CEO)

Oh, I see. Okay.

Thomas Yip (Research Associate)

Thank you.

Dave Luci (President and CEO)

I'll start out with the press release disclosure, and then I'll turn it over to Bob DeLuccia for the scientific conference disclosure. I think some of that is still a bit up in the air. But on the press releases, we'll very likely come out with the first press release on sustained clinical cure in December. In either December or January, we'll have the 94-day out data, the extended clinical cure data, and in January or February, we'll have the data on the microbiome. Then, of course, in March, we'll have the meeting with the FDA, and we'll have a press release around that too, after it's completed. But Bob, did you want to mention the scientific

Bob DeLuccia (Executive Chairman)

Yep.

Dave Luci (President and CEO)

- presentations with the phase II-B data?

Bob DeLuccia (Executive Chairman)

Yeah. I think with some of the data, we targeted in early next year as it becomes available, as Dave said, but concurrently, as we get the final study report, we'll be preparing the data for publication as well.

Thomas Yip (Research Associate)

Great. Thank you. I will definitely look forward to that. Perhaps just one more question from us. This one's financial. You mentioned a little earlier, phase III is expected to be conducted in a sequential manner. Can you provide some preliminary thoughts, estimates on estimated costs for this first phase III study? And what are some options to move forward this initial phase III study?

Dave Luci (President and CEO)

Yeah, I mean, we have ... We're gonna unveil our detailed plan in coming weeks. We think the first of the two trials, and again, this depends on the data, and as you know, it is preliminary, but the first of the two trials will probably range between $20 million and $25 million dollars. So right now, as we sit here with between $9 million and $9.5 million bucks, and we have about another $15 million in warrant exercises, which after more successful data is announced, we expect to see some of that coming in, in terms of cash for the warrant shares. But, you know, beyond that, you know, we don't have a very heavy lift and, and we have a detailed plan.

What I can tell you is it's gonna be as non-dilutive as humanly possible.

Thomas Yip (Research Associate)

Understood. Thank you again for taking our questions. Looking forward to your updates in the next coming months.

Dave Luci (President and CEO)

Very good. Well, thank you, Thomas, and and thanks to Ed as well.

Operator (participant)

Thank you. Our next question is from the line of James Molloy with Alliance Global Partners. Please go ahead.

James Molloy (Managing Director, Senior Biotechnology and Specialty Pharmaceuticals Equity Analyst)

Hi. Good morning. Thank you very much for taking my questions. Could you walk us through a little bit, maybe, a little competitive analysis for, for, you know, Summit with their failure in 2021, but Dificid, you know, back in 2011, obviously with the approval. Can you walk through a little bit the sort of the dosing, the, the reinfection rate, where, what, what Summit went wrong, what, you know, what Merck and Cubist did right on Dificid and how that ties into ibezapolstat, and what you guys are hoping to do here in your phase III?

Dave Luci (President and CEO)

Sure. You know, the Merck example is the most clear example because they went, Merck's predecessor, Optimer, went to phase III, with 15 out of 16 cures, in an open label trial. We had 15 of 16 in phase II-B and another 10 of 10 in phase II-A, so we're going at 25 of 26.... So as Bob mentioned, it's a robust package, and it's supplemented by our manufacturing, preclinical, and other data. So we're delighted with that, and we're following a successful pathway, with the fidaxomicin pathway.

What others have done wrong, so Summit Therapeutics, you mentioned, they conducted a superiority trial, as I understand it, and I wasn't involved, but from what I gather from the public disclosure, they enrolled quite well through COVID at around 169 trial sites internationally. And we like that model for our phase III, which we expect to be international as well. And you can see their sites on ClinicalTrials.gov. But they had a superiority trial, and while they were conducting that trial, James, they actually they changed their primary endpoint and unblinded the data and took a look. And only after that, did they go to the FDA to try to get the FDA to kind of ratify what they did, and the FDA wasn't comfortable with that.

So I don't know exactly how that series of decisions kind of happened. We didn't do that. We contacted the FDA prior to ending the phase II-B trial to make sure that everything was copacetic. And they were, you know, very good at getting back to us quickly. And we also reached out and contacted our Independent Data Monitoring Committee and our Scientific Advisory Board to make sure that we were in unanimous agreement that this was the right decision. And certainly we think it was. So that's a, you know, kind of like an alternative to how Summit kind of ran their phase III. So the thing about Summit's phase III that we like is the pace of their enrollment.

I think they got about 750 patients, internationally, in about two years' time. Our first study will be, I think, somewhere in the neighborhood of 200-ish.

James Molloy (Managing Director, Senior Biotechnology and Specialty Pharmaceuticals Equity Analyst)

Understood. And also, one of the things you talked about was the healthy microbiome with the ibezapolstat. And I know that, again, not to, not to pile on some of it, but they're, they are our most recent relevant company to look at. You know, they were talking about the microbiome and their data as well, obviously didn't help them very much. How do you quantify sort of a healthy microbiome? And how much do you think that plays into the FDA's decision vis-à-vis, you know, just really being non-inferior to vanco?

Dave Luci (President and CEO)

I think it's a burgeoning, you know, fast-growing kind of business sector, the microbiome. And the reason why it's so important is because when you have an imbalanced microbiome, just generally outside of C. diff, it leads to disease, whether it's cancer or C. diff or diabetes. All kinds of things are triggered, as we find more and more, by an imbalanced microbiome. Now, in terms of C. diff, the primary cause of reinfections is an imbalanced microbiome, right? And the C. diff reinfection market is, best estimate, $4.7 billion a year in the U.S. So if you can restore a healthy microbiome, you're basically able to make a very nice dent in the public health cost in the recurrent C. diff market.

So we think that's gonna play an important role, and it's gonna distinguish us from a broad-spectrum antibiotic like oral vanc, which has... It just decimates the microbiome because it's broad spectrum. Now, I think oral vanc was approved in 1986 to treat C. diff because there was so little out there that was useful to treat C. diff. It wasn't that it was the best tool, because it's broad spectrum, not narrow spectrum, but there was just such a need that it got the approval, and its first approval was in 1958. But I hope that answers your question.

James Molloy (Managing Director, Senior Biotechnology and Specialty Pharmaceuticals Equity Analyst)

It does indeed. And just, just a couple of questions if I could, please. Any updates on the PASTEUR Act?

Dave Luci (President and CEO)

We haven't had any updates on the PASTEUR Act specifically. We understand there's a number of different legislative options out there that are being considered. But, you know, I... The more I watch Washington, the more I realize that I have no idea what's going on. I mean, it looks like we're coming up to another government shutdown, and I, I'm sure nobody's thinking, you know, ahead of the holidays. They're trying to keep the government open right now.

James Molloy (Managing Director, Senior Biotechnology and Specialty Pharmaceuticals Equity Analyst)

Okay, maybe just last question for Robert. Keeping a close eye on the accrued expenses here in the third quarter. Can you walk us through what the 82% of that going to one vendor are on that, please?

Dave Luci (President and CEO)

Rob, do you want to?

Rob Shawah (CFO)

Yes, that's our Clinical Research Organization.

Dave Luci (President and CEO)

Yes.

Bob DeLuccia (Executive Chairman)

Our CRO, right?

Rob Shawah (CFO)

Our CRO.

James Molloy (Managing Director, Senior Biotechnology and Specialty Pharmaceuticals Equity Analyst)

Well, great. Thank you for taking the questions.

Dave Luci (President and CEO)

Thank you, James.

Operator (participant)

Thank you. Our next question is from the line of John Stinson, an investor. Please go ahead.

John Stinson (Shareholder)

Thank you for taking my questions. With regard to the 94 day- Can you hear me now?

Dave Luci (President and CEO)

Yes, I can hear you.

John Stinson (Shareholder)

Oh, all right. So with regard to the 94-day study, is it possible that that study, when fully digested, will prove clinical superiority rather than non-inferiority?

Dave Luci (President and CEO)

You know, there will be numbers that people can interpret, but it won't be statistically driven.

Bob DeLuccia (Executive Chairman)

Correct. You're right, then.

John Stinson (Shareholder)

Okay. Then follow-up is, the original, phase II-A and B studies you said were for, to prove non-inferiority. Was it your expectation at that time that it would indeed prove, clinically superior? And was that a disappointment that it did not, or was that just not something you were measuring at all?

Dave Luci (President and CEO)

Well, originally, that was the plan, to measure for statistical non-inferiority and if proven, to test for superiority. But just like with the Independent Data Monitoring Committee mechanism, those mechanisms, you know, kind of got put to bed when we decided to end the phase II-B trial early. Because there were so few patients evaluable in the II-B, there was no mathematical mechanism to measure for non-inferiority or superiority. So in phase II, unlike registration phase III trials, you need to establish clinical comparability to move on to phase III.

So we decided that since we were looking at the blinded data and it looked so positive, you could see how many failures there were, or in our case, there were not, that it was certain to us that we would be able to establish, clinical comparability and move on to phase III. So we didn't want to, for a number of reasons, we didn't want to, waste the time, the money and not have our drug at market as soon as possible. We figured we have a win on the table here, you know, let's, let's take it off the table and move on.

John Stinson (Shareholder)

Okay. Thank you. One last question is, since October 2nd, we've had some very wild swings in the price of this of Acurx as a company, with some days, as many as, an exceeding 8 million, almost 10 million shares being traded in a single day, which is, pretty unusual. Do you have any comments on that?

Dave Luci (President and CEO)

No. I mean, we came out with data, right? So, you know, we're gonna be coming out with even more data, you know, three to five solid press releases in the next, you know, kind of period of time, ending at the end of the first quarter. So we expect, you know, to have a lot more high volume days between now and the end of the first quarter. You know, I will note that as part of the corporate maturation process, this is what happens. You know, at the end of 2022, we were trading about 21,000 shares a day, if you recall, average daily trading volume.

So you know, now as you look at it, you know, in the rearview mirror, as Bob says, you know, we're now entering kind of the midlife of a micro cap pharmaceutical company. And as we, you know, become phase III ready in every sense, it's we expect the trend to continue. What I like about it, and what I will say as well, I like the notion that it seems to me, and this will be coming out more and more through public filings of our ownership. It seems to me that more and more of our shares are entering institutional hands, which is another thing that's very healthy for the company.

John Stinson (Shareholder)

All right. Thank you.

Dave Luci (President and CEO)

Thank you, John.

Operator (participant)

Thank you. Our next question is from the line of Ryan Mulholland with Fifty-Fifty LLC. Please go ahead.

Ryan Mulholland (Shareholder)

Hi, David. Thank you very much for taking the time. Just a couple questions. One regarding the phase II-B trial and the randomization. Was that a block randomization that was used? And are we to assume that the two incomplete participants were then from the vancomycin arm? And then a second question... Oh, you can go for it.

Dave Luci (President and CEO)

Oh, yeah, I was just gonna say, you know, I don't know what a block randomization is, and I wouldn't assume I don't know the two protocol violators. I don't know which arm they were in. What I could tell you is that, the randomization in the II-B was done at the local level, as opposed to a centralized randomization. So I think that means it's not a block randomization, but, but, I'm not entirely sure where the two protocol violators would have come out.

Ryan Mulholland (Shareholder)

Okay, thank you. Do you know if that information will be forthcoming?

Dave Luci (President and CEO)

No, I don't. I mean, I don't expect to know. You know, I haven't-

Ryan Mulholland (Shareholder)

Okay.

Dave Luci (President and CEO)

I haven't asked because they're protocol violators, so, you know, there's nothing that I can assume if I had that information, so I don't even think I asked. So they're just not evaluated.

Ryan Mulholland (Shareholder)

And then lastly, over the past year, you've had several discussions, several interviews where you have discussed potential M&A participation and your kind of interest in not taking ibezapolstat over to phase III yourself, but finding a partner. Is that still something that's on your radar? And are there interesting parties who have signed NDAs to investigate that interest on their own?

Dave Luci (President and CEO)

Yeah. So, you know, there's, there's a lot to, to bite off there, but... Yes, we do have NDAs signed in some cases with interested parties. They being confidential, you know, I can't tell you the names. And yes, M&A is definitely on our calendar for 2024. We think sharing risk with a big pharma partner for phase III in the commercial periods is a prudent idea. Now it takes two parties to create a deal. I'm not certain whether or not a deal will come to fruition, and, you know, we won't know what our value is until we unveil and, you know, find out what the secondary and exploratory endpoints are from the recently completed trial. So, you know, we kind of have to have that information in order to formally launch that process.

But, you know, the first quarter of the year, I'm sure we'll, we'll formally start the process with an asterisk that if we were to get a term sheet in the meantime, then we would be forced, you know, if it were within the ballpark that the Board of Directors finds generally interesting, then they, they may form a special committee and have us move forward earlier than, than we expected. But that's about it. So for now, you know, I would just refer you to the most recent deals in the C. diff space that have been consummated. And you can kind of get an idea of what valuations are, are like. You know, so one deal from November 2020 was when Astellas sold European rights to fidaxomicin to, Tillotts Pharma AG in Europe.

And another deal was the Destiny Pharma deal with Sebela Pharmaceuticals, which looked big, $540 million, but that was only $1 million up front. And the 540 million of all of that money isn't payable until, you know, the very end of the marketing period, which I don't know, might be 15 or 20 years out. So those are the comparables that we see in the space. And, you know, we'll look at our data, and hopefully our data shows a clear separation, and we're able to get something done in terms of M&A in 2024. And we'll be working in on a parallel track with phase III preparation, and we'll see how far we get with each.

Ryan Mulholland (Shareholder)

Well, thank you and your team. Appreciate all your efforts, and it's pretty, pretty great product to put out there.

Dave Luci (President and CEO)

Thank you, Ryan.

Operator (participant)

Thank you. As there are no further questions, I would now hand the conference over to Dave Luci for his closing comments.

Dave Luci (President and CEO)

Thank you very much, Ryan. We're pleased, for all of you, coming to the conference today and expressing your thoughts and questions, and we look forward to updating you soon. Let's sit tight, buckle up, and 2024 is gonna be a great year, we expect. Thank you.

Operator (participant)

Thank you. The conference of Acurx Pharmaceuticals has now concluded. Thank you for your participation. You may now disconnect your lines.