NASDAQ:ACXP Acurx Pharmaceuticals Q3 2023 Earnings Report $0.38 0.00 (-0.63%) Closing price 04/15/2025 04:00 PM EasternExtended Trading$0.38 0.00 (0.00%) As of 04/15/2025 07:59 PM Eastern Extended trading is trading that happens on electronic markets outside of regular trading hours. This is a fair market value extended hours price provided by Polygon.io. Learn more. Earnings HistoryForecast Acurx Pharmaceuticals EPS ResultsActual EPS-$0.24Consensus EPS -$0.28Beat/MissBeat by +$0.04One Year Ago EPSN/AAcurx Pharmaceuticals Revenue ResultsActual RevenueN/AExpected RevenueN/ABeat/MissN/AYoY Revenue GrowthN/AAcurx Pharmaceuticals Announcement DetailsQuarterQ3 2023Date11/13/2023TimeN/AConference Call DateTuesday, November 14, 2023Conference Call Time8:00AM ETUpcoming EarningsAcurx Pharmaceuticals' Q1 2025 earnings is scheduled for Tuesday, May 13, 2025, with a conference call scheduled on Wednesday, May 14, 2025 at 8:00 AM ET. Check back for transcripts, audio, and key financial metrics as they become available.Conference Call ResourcesConference Call AudioConference Call TranscriptPress Release (8-K)Quarterly Report (10-Q)Earnings HistoryCompany ProfilePowered by Acurx Pharmaceuticals Q3 2023 Earnings Call TranscriptProvided by QuartrNovember 14, 2023 ShareLink copied to clipboard.There are 9 speakers on the call. Operator00:00:00Ladies and gentlemen, good morning, and welcome to the Acurex Pharmaceuticals Third Quarter 2023 Earnings Conference Call. As a reminder, this conference is being recorded. It is now my pleasure to introduce your host, Rob Shawa, Chief Financial Officer. Please go ahead. Speaker 100:00:37Thank you, Ryan. Good morning and welcome to our call. This morning, we issued a press release are providing financial results and company highlights for the Q3 of 2023, which is available on our website at participants are in Speaker 200:00:52the line Speaker 100:00:54with the operator for Speaker 200:00:55the Q1 of 2019. Joining me today is Dave Lucci, Speaker 100:00:56President and CEO of Acorex, who will give a corporate update and outlook and Bob DeLucia, our Executive Chairman, who will provide his perspective as the manager of our development programs, including the Phase 2 clinical trial. After Dave's comments, I'll provide some highlights of the financials for the quarter ended September 30, 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 13, 2023. Speaker 100:02:00You are cautioned not to place undue reliance on these forward looking statements and AcuraX 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, are conducting a call to discuss the financial results. Circumstances after the date and time of this conference call. I'll now turn the call over to Dave Lucci. Speaker 300:02:32Dave? Thanks, Rob. Good morning, everyone, and thanks for joining us to review our financial results for the Q3 and also to cover some exciting recent updates, then we'd be pleased to take any questions. On October 2, 2023, we ended enrollment in our Phase 2b clinical trial of Ibezopolstad, our lead antibiotic candidate for the treatment of patients with C. Difficile infection or CDI. Speaker 300:02:58On November 2, 2023, we reported top line data from the Phase 2 clinical trial, including the Ibezepulstat have a clinical cure rate at end of treatment or EOT of 96%, 25 out of 26 patients, including 100% in Phase 2a, 10 for 10 And 94% in Phase 2b, 15% for 2016, as well as the cure rate for oral vancomycin at EOT of 100%, fourteen of the presentation is now concluded in the Phase 2b clinical trial or in the Phase 2b open label Based on the Phase 2 data, in consultation with our scientific advisors, we determined that clear evidence of clinical cure has been established with Ibezopolostat and it is clinically comparable to Vancomycin. In the Phase 2b trial, including sustained clinical cure, extended clinical cure up to 94 days and the comparative impact on the microbiome. Participants. We anticipate that these secondary and exploratory endpoints will provide clear separation between these 2 therapeutic options and all of these endpoints will be disclosed when available over the next 90 days. The Phase 2b trial was originally designed to be a non inferiority trial and later amended to include an interim efficacy analysis with review by an independent data monitoring committee or IDMC. Speaker 300:04:36The decision to end the trial early based on the blinded clinical observations obviated the need for an interim analysis, will be conducting a review of the IDMC review and the non inferiority assessment. The company determined in consultation with its clinical and participants are presenting clinical curates for the primary efficacy endpoint is the most appropriate representation for the clinical activity of Ibezopolostat in treating C. Diff infection. We remain particularly excited about the dual impact are welcome to the call, which we believe is exceptional for antibiotic therapy. Other key highlights from the Q3 or in some cases shortly thereafter include the following. Speaker 300:05:28The World Antimicrobial Resistance Congress convened its annual meeting in Philadelphia in September 2023, where Our Executive Chairman with us today, Bob DeLucia, presented an update entitled Novel DNA PAL3C Inhibitors are participating in the next pandemic. This presentation as well as the others that I'll describe is available on our website at acurexpharmaceuticals.com. At ID Week, Which convened in Boston October 11 to 15, ACCUREX was featured at 2 scheduled events. First, an oral presentation was provided by Doctor. Kevin Gehry, Professor and Chair, University of Houston College of Pharmacy and the Principal are looking forward to the next question and answer session. Speaker 300:06:26Please go ahead. Thank you, Steve. Thank you, Steve. Good morning, everyone. I will now turn the call over to Mr. Speaker 300:06:29President of the selected spectrum activity of Ibezepolstat, secondary analysis from the Phase 2a trial. Secondly, at IDWeek, Actorex presented at the symposium entitled New Antimicrobials in the pipeline. At the symposium, ACTRESS' of the presentation was entitled, novel DNA PAL3C Inhibitors for Gram Positive Bacterial Infections. Next up was the KlossPath meeting, the International Conference on Molecular Biology and Pathogenesis of Clostridia, At which there were 3 scientific posters presented during the conference in Banff, Canada from September 19 to 23. We provided new information supporting Ibezopolostat's unique pharmacologic profile. Speaker 300:07:23The first of the 3 was entitled Ibezopolostat modulates clostridioides difficile virulence factors in vitro showed Ibezopolestat reduces toxin production by C. Diff bacteria. The second entitled C. Diff in vitro biofilm studies of abezopolostat and comparator antibiotics showed abezopolostat was are as effective as the currently used anti C. Diff antibiotics, fedaxomicin, vancomycin and metronidazole, are in the range of the 3rd entitled metagenomic evaluation of abezopulstat compared to other anti C. Speaker 300:08:08Diff agents showed abezopulstat and fedaxomicin both caused favorable proportional increases in Bacteriodes, but distinct from Vancomycin and metronidazole, have been placed on the line of our press release, which caused unfavorable proportional increases in protobacteria. All the presentations again are available on our website. And now back to our CFO, Rob Schauer, to guide you through the highlights of our financial results for the Q3 of 2023. Rob? Speaker 100:08:40Thanks, Dave. Our financial results for the Q3 ended September 30, 2023 were included in our press release is issued earlier this morning. The company ended the 3rd quarter with cash totaling $7,100,000 compared to $9,100,000 in the range of $1,000,000 as of December 31, 2022. I'll also note that subsequent to the quarter have received $2,200,000 in cash from warrant conversions in October of 2023. Research and development expenses for the 3 months ended September 30, 2023 were $1,300,000 compared to $1,600,000 for the 3 months ended September 30 2,022. Speaker 100:09:25The decrease was due to timing of Phase 2b trial related costs. For the 9 months ended September 30, 2023, research and development expenses were $4,100,000 versus $3,300,000 for the 9 months ended September 30, 2022. The increase is due primarily to Phase IIb trial related costs and an increase in consulting costs. General and administrative expenses for the 3 months ended September 30, 2023 were $1,800,000 compared to are $2,000,000 for the 3 months ended September 30, 2022. The decrease was due primarily to a $200,000 decrease in professional fees. Speaker 100:10:09For the 9 months ended September 30, 2023, general and administrative expenses were $5,400,000 have a record quarter of record quarter versus $5,500,000 for the 9 months ended September 30, 2022. The amounts reflect a decrease in professional fees of $300,000 offset by an increase of $200,000 in share based compensation. The company reported a net loss of $3,100,000 or $0.24 per diluted share for the 3 months ended September 30, 2023, are in the range of $3,500,000 or $0.32 per diluted share for the 3 months ended September 30, 2022 and a net loss of $9,500,000 or $0.77 per share for the 9 months ended September 30, 2023, are in the range of $8,800,000 or $0.84 per diluted share for the 9 months ended September 30, 2022, call for the reasons previously mentioned. The company had 13,005,128 shares outstanding as of September 30, are in the range of 2023. With that, I'll turn the call back over Speaker 300:11:26to Dave. Dave? 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 look forward to sustaining this momentum even during these challenging times and sharing future updates in the coming months. Speaker 300:11:47Now in advance of our customary Q and A, I'll ask my Co Founder and Executive Chairman, Bob DeLucia, to provide his perspective given Bob manages our research and development programs, including the recently completed Phase II clinical trial. Bob? Speaker 400:12:04Ready. 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 Ibezopolostat one step closer to commercialization are in need of a promising new antibiotic with a novel bactericidal mechanism of action. And this is especially important in this age of emerging antimicrobial resistance to the currently used antibiotics. So from my perspective, we now have robust scientific evidence to present a strong data package to FDA are ready for an end of Phase II meeting. Speaker 400:12:45The 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 will conduct Phase 3 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. Speaker 400:13:24S. As well. It works extremely well. Is clinically comparable to the standard of care after 10 days old treatment in a serious and potentially life threatening infection that demands 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. Speaker 400:13:55Now since we'll be the only C. Diff antibiotic beginning Phase 3 next year, assuming success, will 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 are looking to deliver a winner here, not only for patients with C. Speaker 400:14:21Diff infection, but in general, for better public health And of course, for our shareholders. In my opinion, simply put, rivesopostat kills the bug and preserves the microbiome. Speaker 300:14:36Participants Thank you, Bob. I'll now open the call for questions. Operator? Participants Operator00:14:42are ready to take questions. I'll begin with the Maxim Group. Please go ahead. Speaker 500:15:24Hey, guys. How's it going? This is Michael Okunowich on the line of the call is open. Thank you, Michael. Speaker 100:15:36So I guess to start off, I'd like to see Operator00:15:38if you can give us Speaker 500:15:39a bit more of an idea of what you're thinking ahead of the end of Phase 2 meeting In terms of what a Phase 3 program could look like in terms of size and scope, potential costs and then also If you would still be targeting non inferiority as a primary endpoint, can you just give me your thoughts on that? Speaker 300:15:59Sure. And yes, we would will 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 2 clinical trials in Phase 3, 2 registration trials. And 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 raised money to fund the smaller first trial and with continued good data in hand, Non inferiority in this case for Phase 3 registration trial. Speaker 300:16:48We 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 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, I think we would ballpark figures, we would try to have a 2 to 1 randomization potentially and preliminarily, If that gets through our science team and the FDA, it might look something like 133 patients on Ibezopolstad and 66 on oral vancomycin. So it would be a much more discrete trial than I think a lot of people are thinking. Speaker 300:17:39So to pay for it won't for a small company, it won't be that challenging. Speaker 500:17:44All right. Thank you for that. And then one more for me and I'll hop in Speaker 100:17:48the queue. Just as we're getting up to those Speaker 500:17:52secondary analyses, could you talk a little bit about what you're looking for Typically, in terms of clinically relevant separation from Vanco, what kind of thresholds you would need to reach in those secondary endpoints? Speaker 300:18:06So 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, 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 is done, but I think that provides clear separation by itself. We're also the only folks that have have gone out formally 94 days for antibiotics in C. Diff at least to see that there are no reinfections that far out. Speaker 300:18:50So I'm particularly excited about that 94 day out data are ready to see in a subset of patients how many patients of ours are reinfections 94 days out compared to Vancomycin. So those are 2 real exciting pieces. And what we're going to do since all of this, all of the secondary and in for any sort of period of time, for the SEC purpose. So we'll be getting the data out as it comes in on participants are in the same period of time. We Speaker 200:19:35will now take a look at the results of the Speaker 300:19:35Q1 of 2019. We will now take a look at the Q1 of 2019. We will now take a look at the Q1 of 2019. Operator00:19:48Our next question is from Ed Arce with H. C. Wainwright. Please go ahead. Speaker 600:19:55Hi, good morning, everyone. This is Thomas Yip asking the further questions for Ed. Thank you for taking the questions. So perhaps first question, I believe you touched on it a little bit. When can we expect to see more Phase 2 data? Speaker 600:20:12Will this Speaker 300:20:18participants I'm sorry, when Can you expect to see the secondary endpoint information? Speaker 600:20:25Yes, that's right. Just additional Phase 2 data additional analysis. Speaker 300:20:31I see. Okay. So we'll have a first press in terms of I'll start out with the press release disclosure and then I'll turn it over to Bob DiLucia 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. Speaker 300:20:55In 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 will be answered after it's completed. But Bob, did you want to mention the scientific presentations with the Phase 2b data? Speaker 400:21:22Yes. I think with some of the data we've 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. Participants are ready. Great. Speaker 600:21:40Thank you. We definitely look forward to that. Perhaps just one more question from us. This one is financial. You mentioned a little earlier Phase 3 is expected to be conducted in a sequential Can you provide some preliminary thoughts estimates on Estimated costs for this first Phase 3 study and what are some options to move forward this initial Phase 3 study? Speaker 300:22:14Yes. I mean, we have we're going to 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 $20,000,000 25,000,000 dollars. Speaker 300:22:35So right now, as we sit here with between $9,000,000 $9,500,000 and we have About another $15,000,000 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 beyond that, We don't have a very heavy lift and we have a detailed plan. And what I can tell you is it's going to be as non dilutive as humanly possible. Speaker 600:23:08Ready. Understood. Thank you again for taking my questions. Looking forward to your updates Operator00:23:25Thank you. Our next question is from the line of James Molloy with Alliance Global Partners. Please go ahead. Speaker 200:23:34Hi, good morning. Thank you very much for taking my questions. Could you walk us through a little bit, maybe a little competitive analysis for Summit with a failure in 'twenty one, but you've said back in 'eleven, obviously, with the approval. Can you walk through a little bit the sort of the dosing, the reinfection rate, What Sumit did wrong, what Merck and Cubis did right on deficit and how that ties into bezepolstat and what you guys are hoping to do here in your Phase 3? Speaker 300:24:00Sure. The Merck example is the most clear example because Merck's predecessor, OPTIMA, went to Phase 3 with 15 out of 16 cures In an open label trial, we have 15 of 16 in 2b and another 10 of 10 in 2a. 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 fedaximycin pathway. Speaker 300:24:38What others have done wrong, so Summit Therapeutics, you mentioned, they conducted a superiority trial, as I understand it, and part of the call is not involved, but from what I gather from the public disclosure, they enrolled are doing quite well through COVID at around 169 trial sites internationally. And we like that model for our Phase 3, which We expect to be international as well. And you can see their sites on clinicaltrial.gov. But they had a superiority trial. And while they are conducting that trial, Jim, they actually tried they changed their primary endpoint And unblinded the data and took a look. Speaker 300:25:22And only after that did they go to the FDA to try to get the FDA 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 2b trial to make sure that everything was copacetic And they were 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 are in unanimous agreement that this was the right decision. And certainly, we think it was. Speaker 300:26:03Part So that's 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 7 50 patients internationally in about 2 at this time, our first study will be, I think somewhere in the neighborhood of 200 ish. Speaker 200:26:28Understood. And I also wonder if you had talked about the healthy microbiome with the bevoprolstat. And I know that, again, Not to pile on some of it, but they are our most recent relevant company to look at. They were talking about the microbiome and their data as well, obviously I didn't help them very much. How do you quantify some of the healthy microbiome and how much do you think that plays into the FDA's decision visavis Just really being non inferior to Vanco. Speaker 300:26:55I think it's a burgeoning fast growing kind of business sector, the microbiome. And the reason why it's so important is because when you have an imbalance microbiome, Just generally outside of C. Diff, it leads to disease, whether it's cancer, C. Diff or diabetes, all kinds of things are triggered as we find more and more by an imbalance microbiome. Now in terms of C. Speaker 300:27:24Diff, The primary cause of reinfections is an imbalance microbiome, right? And the C. Diff reinfection market is Best estimate, dollars 4,700,000,000 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. Speaker 300:27:51Diff market. So, we think that's going to play an important role and it's going to distinguish us from a broad spectrum antibiotic like oral Vanc, Which has it just decimates the microbiome because it's broad spectrum. I think oral Vanc was approved in 1986 to treat C. Diff Because there was so little out there that was useful to treat CDIF. 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. Speaker 300:28:24I hope that answers your question. Speaker 200:28:27He does indeed. And just a couple of questions, if I could, please. Any updates on the Pasteur Act? Speaker 300:28:33We haven't had any options out there that are being considered, but 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'm sure nobody is thinking ahead of the holidays. They're trying to keep the government open right now. Speaker 200:29:02Participants are open. Okay. Maybe just a last question for Robert. Keeping a close eye on the accrued expenses here in In the Q3, can you walk us through what the 82% of the Go On to One vendor are on that, please? Speaker 300:29:15Rob, do you want to Rob or Rob? Speaker 100:29:18Yes. That's our clinical research organization. Speaker 400:29:24Our CRO. Our CRO. Operator00:29:35Ready. Thank you. Our next question is from the line of John Stinson, an investor. Please go ahead. Speaker 700:29:44Participants. Thank you for taking my questions. With regard to the 94 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? Speaker 300:30:19Participants There will be numbers that people can interpret, but it won't be statistically driven. Speaker 700:30:34Okay. Then follow-up is the original Phase 2 A and B studies you said were for to prove non inferiority. Was it your Expectation at the 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? Speaker 300:31:06Well, originally, that was the plan to measure for statistical non inferiority and if proven attest 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 2b trial early because there were so few patients evaluable in the 2b. There was no mathematical mechanism to measure for non inferiority or superiority. So in Phase 2, unlike registration Phase 3 trials, you need to establish clinical comparability To move on to Phase 3. So we decided that since we are looking at the blinded data and it looks so positive. You could see how many failures there were, or in our case, there were not, that it was are certain to us that we would be able to establish clinical comparability and move on to Phase 3. Speaker 300:32:05So 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. Participants, let's take it off the table and move on. Speaker 700:32:22Okay, thank you. One last question Since October 2, we've had some very wild swings in the price of this baccarix participants are in the range of $1,000,000 Almost 10,000,000 shares being traded in a single day, which is pretty unusual. Do you have any comments on that? Speaker 300:32:54No. I mean, we came out with data, right? So we're going to be coming out with even more data, 3 to 5 solid press releases in the next kind of period of time ending at the end of the Q1. So we expect to have a lot more high volume days between now and the end of the first quarter. I will note that as part of the corporate maturation process, this is what happens. Speaker 300:33:22At the end of 2022, We were trading about 21,000 shares a day if you recall average daily trading volume. So now as you look at it In the rearview mirror, as Bob says, we're now entering kind of the midlife of MicroCap Pharmaceutical Company and as we become Phase 3 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 are entering institutional hands, which is another thing that's very healthy for the company. Speaker 700:34:11Part. Thank you. Speaker 300:34:13Thank you, John. Operator00:34:16Thank you. Our next question is from the line of Ryan Mulholland with 5050 LLC. Please go ahead. Speaker 800:34:27Hi, David. Thank you very much for taking the time. Just a couple of questions. One regarding the Phase 2b trial And the randomization, was that a block randomization that was used? And are we to assume that the 2 incomplete participants were then from the vancomycin arm. Speaker 800:34:50And then second question all part? Speaker 300:34:55Oh, yes. I was just going to say, I don't know what a block randomization is and I wouldn't assume. I don't know the 2 protocol violators. I don't know which arm they were in. What I can tell you is that the randomization in the 2b Was done at the local level, as opposed to the centralized randomization. Speaker 300:35:15So I think that means it's not a block randomization, part But I'm not entirely sure where the 2 protocol violators would have come out. Speaker 800:35:29Okay. Thank you. Do you know if that information will be forthcoming? Speaker 300:35:35Part I don't expect to know. I haven't asked because they're protocol violators. There's nothing that I can assume if I had that information. So I don't even think I asked. So that's not evaluated. Speaker 800:35:54And then lastly, over the past year, you've had have several discussions, several interviews where you have discussed potential of the presentation and your kind of interest in not taking Are there interesting parties who have signed NDAs to investigate that interest on their own? Speaker 300:36:34Yes. So there's a lot to bite off there. But yes, we do have NDA signed in some cases with interested parties, they being confidential, I can't tell you the names. And yes, M and A is definitely on our calendar for 2024. We think sharing risk with a big pharma partner for Phase 3 in the commercial period is a prudent idea. Speaker 300:37:04Now, it takes 2 parties to create a deal. I'm not certain whether or not a deal will come to fruition. And participants are in the secondary and exploratory endpoints are from the recently completed trial. So, we kind of have to have that information in order to formally launch that process. In the Q1 of the year, I'm sure 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 if it were within the ballpark that the Board of Directors finds generally Interesting. Speaker 300:37:49And they may form a special committee and have us move forward earlier than we expected. But that's about it. So for now, 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 like. So one deal from November 2020 was when Astellas sold European rights to fidaxomicin will be available to Tillett Pharma AG in Europe. Speaker 300:38:24And another deal was the Destiny Pharma deal with Cibila Pharmaceuticals, Which look big, dollars 540,000,000 but that was only $1,000,000 upfront and the 540th 1,000,000 of all of that money isn't payable until the very end of the marketing period, which I don't know, it might be 15 or 20 years out. So, those are the comparables that we see in the space. And we'll look at our data and hopefully our data shows clear separation and we're able to get something done In terms of M and A in 2024 and we'll be working on a parallel track with Phase 3 preparation and We'll see how far we get with each. Speaker 800:39:17Well, thank you and your team. I appreciate all your efforts and it's Operator00:39:26Thank you. As there are no further questions, I would now hand the conference over to Dave Lucci for his closing comments. Speaker 300:39:39Thank you very much, Ryan. We're pleased for all of you coming to the conference today and are expressing your thoughts and questions and we look forward to updating you soon. Let's sit tight and buckle up and 2024 is going to be a great year we participants. Operator00:39:59Thank you. The conference of Accurix Pharmaceuticals has now concluded. Thank you for your participation. You may now disconnect your lines.Read moreRemove AdsPowered by Conference Call Audio Live Call not available Earnings Conference CallAcurx Pharmaceuticals Q3 202300:00 / 00:00Speed:1x1.25x1.5x2xRemove Ads Earnings DocumentsPress Release(8-K)Quarterly report(10-Q) Acurx Pharmaceuticals Earnings HeadlinesAcurx files to sell 8.4M shares of common stock for holdersApril 5, 2025 | markets.businessinsider.comAcurx Pharmaceuticals, Inc. (NASDAQ:ACXP) Q4 2024 Earnings Call TranscriptMarch 19, 2025 | msn.comThe Crypto Market is About to Change LivesI've discovered something so significant about the 2025 crypto market that I had to put everything else aside and write a book about it. This isn't just another Bitcoin prediction – it's a complete roadmap for what I believe will be the biggest wealth-building opportunity of this decade. The evidence is so compelling, I'm doing something that probably seems insane: I'm giving away my entire book for free. April 16, 2025 | Crypto 101 Media (Ad)Acurx reports Q4 EPS (16c) vs. (37c) last yearMarch 18, 2025 | markets.businessinsider.comAcurx price target lowered to $5 from $14 at Alliance Global PartnersMarch 18, 2025 | markets.businessinsider.comAcurx Pharmaceuticals, Inc. (ACXP) Q4 2024 Earnings Call TranscriptMarch 18, 2025 | seekingalpha.comSee More Acurx Pharmaceuticals Headlines Get Earnings Announcements in your inboxWant to stay updated on the latest earnings announcements and upcoming reports for companies like Acurx Pharmaceuticals? Sign up for Earnings360's daily newsletter to receive timely earnings updates on Acurx Pharmaceuticals and other key companies, straight to your email. Email Address About Acurx PharmaceuticalsAcurx Pharmaceuticals (NASDAQ:ACXP), a clinical stage biopharmaceutical company, develops antibiotics to treat bacterial infections. The company's lead antibiotic candidate is ibezapolstat, a novel mechanism of action that targets the polymerase IIIC enzyme that is in Phase 2b clinical trial to treat patients with clostridium difficile infections. It also develops ACX-375C, a potential oral and parenteral treatment targeting gram-positive bacteria, including methicillin-resistant staphylococcus aureus, vancomycin-resistant enterococcus, and penicillin-resistant streptococcus pneumonia. 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There are 9 speakers on the call. Operator00:00:00Ladies and gentlemen, good morning, and welcome to the Acurex Pharmaceuticals Third Quarter 2023 Earnings Conference Call. As a reminder, this conference is being recorded. It is now my pleasure to introduce your host, Rob Shawa, Chief Financial Officer. Please go ahead. Speaker 100:00:37Thank you, Ryan. Good morning and welcome to our call. This morning, we issued a press release are providing financial results and company highlights for the Q3 of 2023, which is available on our website at participants are in Speaker 200:00:52the line Speaker 100:00:54with the operator for Speaker 200:00:55the Q1 of 2019. Joining me today is Dave Lucci, Speaker 100:00:56President and CEO of Acorex, who will give a corporate update and outlook and Bob DeLucia, our Executive Chairman, who will provide his perspective as the manager of our development programs, including the Phase 2 clinical trial. After Dave's comments, I'll provide some highlights of the financials for the quarter ended September 30, 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 13, 2023. Speaker 100:02:00You are cautioned not to place undue reliance on these forward looking statements and AcuraX 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, are conducting a call to discuss the financial results. Circumstances after the date and time of this conference call. I'll now turn the call over to Dave Lucci. Speaker 300:02:32Dave? Thanks, Rob. Good morning, everyone, and thanks for joining us to review our financial results for the Q3 and also to cover some exciting recent updates, then we'd be pleased to take any questions. On October 2, 2023, we ended enrollment in our Phase 2b clinical trial of Ibezopolstad, our lead antibiotic candidate for the treatment of patients with C. Difficile infection or CDI. Speaker 300:02:58On November 2, 2023, we reported top line data from the Phase 2 clinical trial, including the Ibezepulstat have a clinical cure rate at end of treatment or EOT of 96%, 25 out of 26 patients, including 100% in Phase 2a, 10 for 10 And 94% in Phase 2b, 15% for 2016, as well as the cure rate for oral vancomycin at EOT of 100%, fourteen of the presentation is now concluded in the Phase 2b clinical trial or in the Phase 2b open label Based on the Phase 2 data, in consultation with our scientific advisors, we determined that clear evidence of clinical cure has been established with Ibezopolostat and it is clinically comparable to Vancomycin. In the Phase 2b trial, including sustained clinical cure, extended clinical cure up to 94 days and the comparative impact on the microbiome. Participants. We anticipate that these secondary and exploratory endpoints will provide clear separation between these 2 therapeutic options and all of these endpoints will be disclosed when available over the next 90 days. The Phase 2b trial was originally designed to be a non inferiority trial and later amended to include an interim efficacy analysis with review by an independent data monitoring committee or IDMC. Speaker 300:04:36The decision to end the trial early based on the blinded clinical observations obviated the need for an interim analysis, will be conducting a review of the IDMC review and the non inferiority assessment. The company determined in consultation with its clinical and participants are presenting clinical curates for the primary efficacy endpoint is the most appropriate representation for the clinical activity of Ibezopolostat in treating C. Diff infection. We remain particularly excited about the dual impact are welcome to the call, which we believe is exceptional for antibiotic therapy. Other key highlights from the Q3 or in some cases shortly thereafter include the following. Speaker 300:05:28The World Antimicrobial Resistance Congress convened its annual meeting in Philadelphia in September 2023, where Our Executive Chairman with us today, Bob DeLucia, presented an update entitled Novel DNA PAL3C Inhibitors are participating in the next pandemic. This presentation as well as the others that I'll describe is available on our website at acurexpharmaceuticals.com. At ID Week, Which convened in Boston October 11 to 15, ACCUREX was featured at 2 scheduled events. First, an oral presentation was provided by Doctor. Kevin Gehry, Professor and Chair, University of Houston College of Pharmacy and the Principal are looking forward to the next question and answer session. Speaker 300:06:26Please go ahead. Thank you, Steve. Thank you, Steve. Good morning, everyone. I will now turn the call over to Mr. Speaker 300:06:29President of the selected spectrum activity of Ibezepolstat, secondary analysis from the Phase 2a trial. Secondly, at IDWeek, Actorex presented at the symposium entitled New Antimicrobials in the pipeline. At the symposium, ACTRESS' of the presentation was entitled, novel DNA PAL3C Inhibitors for Gram Positive Bacterial Infections. Next up was the KlossPath meeting, the International Conference on Molecular Biology and Pathogenesis of Clostridia, At which there were 3 scientific posters presented during the conference in Banff, Canada from September 19 to 23. We provided new information supporting Ibezopolostat's unique pharmacologic profile. Speaker 300:07:23The first of the 3 was entitled Ibezopolostat modulates clostridioides difficile virulence factors in vitro showed Ibezopolestat reduces toxin production by C. Diff bacteria. The second entitled C. Diff in vitro biofilm studies of abezopolostat and comparator antibiotics showed abezopolostat was are as effective as the currently used anti C. Diff antibiotics, fedaxomicin, vancomycin and metronidazole, are in the range of the 3rd entitled metagenomic evaluation of abezopulstat compared to other anti C. Speaker 300:08:08Diff agents showed abezopulstat and fedaxomicin both caused favorable proportional increases in Bacteriodes, but distinct from Vancomycin and metronidazole, have been placed on the line of our press release, which caused unfavorable proportional increases in protobacteria. All the presentations again are available on our website. And now back to our CFO, Rob Schauer, to guide you through the highlights of our financial results for the Q3 of 2023. Rob? Speaker 100:08:40Thanks, Dave. Our financial results for the Q3 ended September 30, 2023 were included in our press release is issued earlier this morning. The company ended the 3rd quarter with cash totaling $7,100,000 compared to $9,100,000 in the range of $1,000,000 as of December 31, 2022. I'll also note that subsequent to the quarter have received $2,200,000 in cash from warrant conversions in October of 2023. Research and development expenses for the 3 months ended September 30, 2023 were $1,300,000 compared to $1,600,000 for the 3 months ended September 30 2,022. Speaker 100:09:25The decrease was due to timing of Phase 2b trial related costs. For the 9 months ended September 30, 2023, research and development expenses were $4,100,000 versus $3,300,000 for the 9 months ended September 30, 2022. The increase is due primarily to Phase IIb trial related costs and an increase in consulting costs. General and administrative expenses for the 3 months ended September 30, 2023 were $1,800,000 compared to are $2,000,000 for the 3 months ended September 30, 2022. The decrease was due primarily to a $200,000 decrease in professional fees. Speaker 100:10:09For the 9 months ended September 30, 2023, general and administrative expenses were $5,400,000 have a record quarter of record quarter versus $5,500,000 for the 9 months ended September 30, 2022. The amounts reflect a decrease in professional fees of $300,000 offset by an increase of $200,000 in share based compensation. The company reported a net loss of $3,100,000 or $0.24 per diluted share for the 3 months ended September 30, 2023, are in the range of $3,500,000 or $0.32 per diluted share for the 3 months ended September 30, 2022 and a net loss of $9,500,000 or $0.77 per share for the 9 months ended September 30, 2023, are in the range of $8,800,000 or $0.84 per diluted share for the 9 months ended September 30, 2022, call for the reasons previously mentioned. The company had 13,005,128 shares outstanding as of September 30, are in the range of 2023. With that, I'll turn the call back over Speaker 300:11:26to Dave. Dave? 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 look forward to sustaining this momentum even during these challenging times and sharing future updates in the coming months. Speaker 300:11:47Now in advance of our customary Q and A, I'll ask my Co Founder and Executive Chairman, Bob DeLucia, to provide his perspective given Bob manages our research and development programs, including the recently completed Phase II clinical trial. Bob? Speaker 400:12:04Ready. 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 Ibezopolostat one step closer to commercialization are in need of a promising new antibiotic with a novel bactericidal mechanism of action. And this is especially important in this age of emerging antimicrobial resistance to the currently used antibiotics. So from my perspective, we now have robust scientific evidence to present a strong data package to FDA are ready for an end of Phase II meeting. Speaker 400:12:45The 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 will conduct Phase 3 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. Speaker 400:13:24S. As well. It works extremely well. Is clinically comparable to the standard of care after 10 days old treatment in a serious and potentially life threatening infection that demands 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. Speaker 400:13:55Now since we'll be the only C. Diff antibiotic beginning Phase 3 next year, assuming success, will 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 are looking to deliver a winner here, not only for patients with C. Speaker 400:14:21Diff infection, but in general, for better public health And of course, for our shareholders. In my opinion, simply put, rivesopostat kills the bug and preserves the microbiome. Speaker 300:14:36Participants Thank you, Bob. I'll now open the call for questions. Operator? Participants Operator00:14:42are ready to take questions. I'll begin with the Maxim Group. Please go ahead. Speaker 500:15:24Hey, guys. How's it going? This is Michael Okunowich on the line of the call is open. Thank you, Michael. Speaker 100:15:36So I guess to start off, I'd like to see Operator00:15:38if you can give us Speaker 500:15:39a bit more of an idea of what you're thinking ahead of the end of Phase 2 meeting In terms of what a Phase 3 program could look like in terms of size and scope, potential costs and then also If you would still be targeting non inferiority as a primary endpoint, can you just give me your thoughts on that? Speaker 300:15:59Sure. And yes, we would will 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 2 clinical trials in Phase 3, 2 registration trials. And 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 raised money to fund the smaller first trial and with continued good data in hand, Non inferiority in this case for Phase 3 registration trial. Speaker 300:16:48We 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 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, I think we would ballpark figures, we would try to have a 2 to 1 randomization potentially and preliminarily, If that gets through our science team and the FDA, it might look something like 133 patients on Ibezopolstad and 66 on oral vancomycin. So it would be a much more discrete trial than I think a lot of people are thinking. Speaker 300:17:39So to pay for it won't for a small company, it won't be that challenging. Speaker 500:17:44All right. Thank you for that. And then one more for me and I'll hop in Speaker 100:17:48the queue. Just as we're getting up to those Speaker 500:17:52secondary analyses, could you talk a little bit about what you're looking for Typically, in terms of clinically relevant separation from Vanco, what kind of thresholds you would need to reach in those secondary endpoints? Speaker 300:18:06So 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, 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 is done, but I think that provides clear separation by itself. We're also the only folks that have have gone out formally 94 days for antibiotics in C. Diff at least to see that there are no reinfections that far out. Speaker 300:18:50So I'm particularly excited about that 94 day out data are ready to see in a subset of patients how many patients of ours are reinfections 94 days out compared to Vancomycin. So those are 2 real exciting pieces. And what we're going to do since all of this, all of the secondary and in for any sort of period of time, for the SEC purpose. So we'll be getting the data out as it comes in on participants are in the same period of time. We Speaker 200:19:35will now take a look at the results of the Speaker 300:19:35Q1 of 2019. We will now take a look at the Q1 of 2019. We will now take a look at the Q1 of 2019. Operator00:19:48Our next question is from Ed Arce with H. C. Wainwright. Please go ahead. Speaker 600:19:55Hi, good morning, everyone. This is Thomas Yip asking the further questions for Ed. Thank you for taking the questions. So perhaps first question, I believe you touched on it a little bit. When can we expect to see more Phase 2 data? Speaker 600:20:12Will this Speaker 300:20:18participants I'm sorry, when Can you expect to see the secondary endpoint information? Speaker 600:20:25Yes, that's right. Just additional Phase 2 data additional analysis. Speaker 300:20:31I see. Okay. So we'll have a first press in terms of I'll start out with the press release disclosure and then I'll turn it over to Bob DiLucia 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. Speaker 300:20:55In 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 will be answered after it's completed. But Bob, did you want to mention the scientific presentations with the Phase 2b data? Speaker 400:21:22Yes. I think with some of the data we've 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. Participants are ready. Great. Speaker 600:21:40Thank you. We definitely look forward to that. Perhaps just one more question from us. This one is financial. You mentioned a little earlier Phase 3 is expected to be conducted in a sequential Can you provide some preliminary thoughts estimates on Estimated costs for this first Phase 3 study and what are some options to move forward this initial Phase 3 study? Speaker 300:22:14Yes. I mean, we have we're going to 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 $20,000,000 25,000,000 dollars. Speaker 300:22:35So right now, as we sit here with between $9,000,000 $9,500,000 and we have About another $15,000,000 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 beyond that, We don't have a very heavy lift and we have a detailed plan. And what I can tell you is it's going to be as non dilutive as humanly possible. Speaker 600:23:08Ready. Understood. Thank you again for taking my questions. Looking forward to your updates Operator00:23:25Thank you. Our next question is from the line of James Molloy with Alliance Global Partners. Please go ahead. Speaker 200:23:34Hi, good morning. Thank you very much for taking my questions. Could you walk us through a little bit, maybe a little competitive analysis for Summit with a failure in 'twenty one, but you've said back in 'eleven, obviously, with the approval. Can you walk through a little bit the sort of the dosing, the reinfection rate, What Sumit did wrong, what Merck and Cubis did right on deficit and how that ties into bezepolstat and what you guys are hoping to do here in your Phase 3? Speaker 300:24:00Sure. The Merck example is the most clear example because Merck's predecessor, OPTIMA, went to Phase 3 with 15 out of 16 cures In an open label trial, we have 15 of 16 in 2b and another 10 of 10 in 2a. 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 fedaximycin pathway. Speaker 300:24:38What others have done wrong, so Summit Therapeutics, you mentioned, they conducted a superiority trial, as I understand it, and part of the call is not involved, but from what I gather from the public disclosure, they enrolled are doing quite well through COVID at around 169 trial sites internationally. And we like that model for our Phase 3, which We expect to be international as well. And you can see their sites on clinicaltrial.gov. But they had a superiority trial. And while they are conducting that trial, Jim, they actually tried they changed their primary endpoint And unblinded the data and took a look. Speaker 300:25:22And only after that did they go to the FDA to try to get the FDA 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 2b trial to make sure that everything was copacetic And they were 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 are in unanimous agreement that this was the right decision. And certainly, we think it was. Speaker 300:26:03Part So that's 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 7 50 patients internationally in about 2 at this time, our first study will be, I think somewhere in the neighborhood of 200 ish. Speaker 200:26:28Understood. And I also wonder if you had talked about the healthy microbiome with the bevoprolstat. And I know that, again, Not to pile on some of it, but they are our most recent relevant company to look at. They were talking about the microbiome and their data as well, obviously I didn't help them very much. How do you quantify some of the healthy microbiome and how much do you think that plays into the FDA's decision visavis Just really being non inferior to Vanco. Speaker 300:26:55I think it's a burgeoning fast growing kind of business sector, the microbiome. And the reason why it's so important is because when you have an imbalance microbiome, Just generally outside of C. Diff, it leads to disease, whether it's cancer, C. Diff or diabetes, all kinds of things are triggered as we find more and more by an imbalance microbiome. Now in terms of C. Speaker 300:27:24Diff, The primary cause of reinfections is an imbalance microbiome, right? And the C. Diff reinfection market is Best estimate, dollars 4,700,000,000 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. Speaker 300:27:51Diff market. So, we think that's going to play an important role and it's going to distinguish us from a broad spectrum antibiotic like oral Vanc, Which has it just decimates the microbiome because it's broad spectrum. I think oral Vanc was approved in 1986 to treat C. Diff Because there was so little out there that was useful to treat CDIF. 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. Speaker 300:28:24I hope that answers your question. Speaker 200:28:27He does indeed. And just a couple of questions, if I could, please. Any updates on the Pasteur Act? Speaker 300:28:33We haven't had any options out there that are being considered, but 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'm sure nobody is thinking ahead of the holidays. They're trying to keep the government open right now. Speaker 200:29:02Participants are open. Okay. Maybe just a last question for Robert. Keeping a close eye on the accrued expenses here in In the Q3, can you walk us through what the 82% of the Go On to One vendor are on that, please? Speaker 300:29:15Rob, do you want to Rob or Rob? Speaker 100:29:18Yes. That's our clinical research organization. Speaker 400:29:24Our CRO. Our CRO. Operator00:29:35Ready. Thank you. Our next question is from the line of John Stinson, an investor. Please go ahead. Speaker 700:29:44Participants. Thank you for taking my questions. With regard to the 94 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? Speaker 300:30:19Participants There will be numbers that people can interpret, but it won't be statistically driven. Speaker 700:30:34Okay. Then follow-up is the original Phase 2 A and B studies you said were for to prove non inferiority. Was it your Expectation at the 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? Speaker 300:31:06Well, originally, that was the plan to measure for statistical non inferiority and if proven attest 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 2b trial early because there were so few patients evaluable in the 2b. There was no mathematical mechanism to measure for non inferiority or superiority. So in Phase 2, unlike registration Phase 3 trials, you need to establish clinical comparability To move on to Phase 3. So we decided that since we are looking at the blinded data and it looks so positive. You could see how many failures there were, or in our case, there were not, that it was are certain to us that we would be able to establish clinical comparability and move on to Phase 3. Speaker 300:32:05So 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. Participants, let's take it off the table and move on. Speaker 700:32:22Okay, thank you. One last question Since October 2, we've had some very wild swings in the price of this baccarix participants are in the range of $1,000,000 Almost 10,000,000 shares being traded in a single day, which is pretty unusual. Do you have any comments on that? Speaker 300:32:54No. I mean, we came out with data, right? So we're going to be coming out with even more data, 3 to 5 solid press releases in the next kind of period of time ending at the end of the Q1. So we expect to have a lot more high volume days between now and the end of the first quarter. I will note that as part of the corporate maturation process, this is what happens. Speaker 300:33:22At the end of 2022, We were trading about 21,000 shares a day if you recall average daily trading volume. So now as you look at it In the rearview mirror, as Bob says, we're now entering kind of the midlife of MicroCap Pharmaceutical Company and as we become Phase 3 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 are entering institutional hands, which is another thing that's very healthy for the company. Speaker 700:34:11Part. Thank you. Speaker 300:34:13Thank you, John. Operator00:34:16Thank you. Our next question is from the line of Ryan Mulholland with 5050 LLC. Please go ahead. Speaker 800:34:27Hi, David. Thank you very much for taking the time. Just a couple of questions. One regarding the Phase 2b trial And the randomization, was that a block randomization that was used? And are we to assume that the 2 incomplete participants were then from the vancomycin arm. Speaker 800:34:50And then second question all part? Speaker 300:34:55Oh, yes. I was just going to say, I don't know what a block randomization is and I wouldn't assume. I don't know the 2 protocol violators. I don't know which arm they were in. What I can tell you is that the randomization in the 2b Was done at the local level, as opposed to the centralized randomization. Speaker 300:35:15So I think that means it's not a block randomization, part But I'm not entirely sure where the 2 protocol violators would have come out. Speaker 800:35:29Okay. Thank you. Do you know if that information will be forthcoming? Speaker 300:35:35Part I don't expect to know. I haven't asked because they're protocol violators. There's nothing that I can assume if I had that information. So I don't even think I asked. So that's not evaluated. Speaker 800:35:54And then lastly, over the past year, you've had have several discussions, several interviews where you have discussed potential of the presentation and your kind of interest in not taking Are there interesting parties who have signed NDAs to investigate that interest on their own? Speaker 300:36:34Yes. So there's a lot to bite off there. But yes, we do have NDA signed in some cases with interested parties, they being confidential, I can't tell you the names. And yes, M and A is definitely on our calendar for 2024. We think sharing risk with a big pharma partner for Phase 3 in the commercial period is a prudent idea. Speaker 300:37:04Now, it takes 2 parties to create a deal. I'm not certain whether or not a deal will come to fruition. And participants are in the secondary and exploratory endpoints are from the recently completed trial. So, we kind of have to have that information in order to formally launch that process. In the Q1 of the year, I'm sure 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 if it were within the ballpark that the Board of Directors finds generally Interesting. Speaker 300:37:49And they may form a special committee and have us move forward earlier than we expected. But that's about it. So for now, 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 like. So one deal from November 2020 was when Astellas sold European rights to fidaxomicin will be available to Tillett Pharma AG in Europe. Speaker 300:38:24And another deal was the Destiny Pharma deal with Cibila Pharmaceuticals, Which look big, dollars 540,000,000 but that was only $1,000,000 upfront and the 540th 1,000,000 of all of that money isn't payable until the very end of the marketing period, which I don't know, it might be 15 or 20 years out. So, those are the comparables that we see in the space. And we'll look at our data and hopefully our data shows clear separation and we're able to get something done In terms of M and A in 2024 and we'll be working on a parallel track with Phase 3 preparation and We'll see how far we get with each. Speaker 800:39:17Well, thank you and your team. I appreciate all your efforts and it's Operator00:39:26Thank you. As there are no further questions, I would now hand the conference over to Dave Lucci for his closing comments. Speaker 300:39:39Thank you very much, Ryan. We're pleased for all of you coming to the conference today and are expressing your thoughts and questions and we look forward to updating you soon. Let's sit tight and buckle up and 2024 is going to be a great year we participants. Operator00:39:59Thank you. The conference of Accurix Pharmaceuticals has now concluded. Thank you for your participation. You may now disconnect your lines.Read moreRemove AdsPowered by