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spk02: Hello, and welcome to the AccuRx Pharmaceuticals first quarter 2024 financial results conference call. If anyone would require operator assistance, please press star zero on your telephone keypad. A question and answer session will follow the formal presentation. You may be placed into question queue at any time by pressing star one. As a reminder, this conference is being recorded. It's now my pleasure to turn the conference over to CFO Robert Shala. Please go ahead.
spk01: Thank you, Kevin. Good morning, and welcome to our call. This morning, we issued a press release providing financial results and company highlights for the first quarter of 2024, which is available on our website at accorexpharma.com. Joining me today is Dave Lucci, President and CEO of Accorex, who will give a corporate update and outlook, as well as our Executive Chairman, Bob DeLuccia. After that, I'll provide some highlights of the financials from the quarter ended March 31, 2024, then turn the call back over to Dave and Bob for their 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. They're 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 on Tuesday, May 14th, 2024. Your caution not to place undue reliance on these forward-looking statements and that corrects, disclaims any obligation to update these 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, May 15, 2024. I'll now turn the call over to Dave Lucci. Dave?
spk04: Thanks, Rob. Good morning, everyone, and thanks for joining us to review our financial results for the first quarter and also to hear some exciting recent updates. Then we'd be pleased to take any questions. First, I'll summarize some of our key activities for the first quarter of 2024. or in some cases, shortly thereafter. In January, we announced positive comparative microbiology and microbiome data for Ibezopulstat, our lead antibiotic candidate, in C. diff patients from the Phase IIb clinical trial segment. Ibezopulstat outperformed vancomycin, a standard of care, showing eradication of fecal C. difficile at day three of treatment in 15 of 16 patients. treated patients, 94%, versus vancomycin, which had eradication of C. difficile in 10 of 14 treated patients, or 71%. Additional data from the Phase IIb clinical trial showed that Bezopulstat, but not vancomycin, consistently preserved and allowed regrowth of key gut bacterial species believed to confer health benefits, including preventing recurrent C. diff infections. Additional data from exploratory endpoints will provide further favorable separation between these two therapeutic options in our Phase III clinical trial program and ultimately in the marketplace, if approved. We remain particularly excited about the dual impact of ibuprofen to treat acute C. difficile on the one hand, while appropriately managing the long-term care of each patient's microbiome, which we believe is truly exceptional for antibiotic therapy. Having robust preclinical, clinical, and manufacturing data to date, we submitted in January a formable information package to the FDA, along with a request for an end-of-Phase II meeting, which was granted on February 26th, and the meeting was convened on April 17th. At the FDA meeting, we reached agreement on key elements of our Phase III program. including, importantly, agreement with the FDA regarding readiness to proceed to Phase 3, as well as agreement on the regulatory pathway for a new drug application filing for marketing approval in the U.S. We will press release further details on the FDA meeting pre-market this morning. In February, we announced that the European Medicines Agency approved our application to be designated as a Small to Medium-Sized Enterprise, or SME. in Europe, which provides for certain benefits, including fee reductions and other support from the agency, for seeking a marketing authorization in Europe. We attended the European Society of Microbiology and Infectious Disease, or ESCMID, scientific congress in April 2024, where Dr. Kevin Geary, Professor and Chair, University of Houston College of Pharmacy, and the principal investigator for microbiology and microbiome aspects of our clinical trial program, and our scientific advisory board member, provided an oral presentation of Phase II data entitled, A Phase II Randomized Double-Blind Study of Ibezapustat Compared with Vecamisin for the Treatment of C. difficile Infection. The presentation included additional analyses of clinical and microbiological data and is available on our website at www.accurexpharmaceuticals.com. The complete Phase II results are being prepared for submission to a prominent scientific journal for publication this year. Throughout the rest of this year, we'll continue to roll out our Phase II results in either oral presentations or scientific posters, or in some cases both, which will include results from new analyses as data become available at various prominent scientific conferences, including the Houston C. diff and microbiome conference later this month, the Antirope Society of America annual conference in July, the World Antimicrobial Resistance Conference in September, also in September is the International C. diff Symposium, and, of course, the annual meeting of the Infectious Disease Society of America, or ID Week, in October. Throughout the first quarter, we continued preparations for Phase III trials, including advances in micro and manufacturing, CRO selection and clinical site screening, and building a team of international drug development experts to support our Phase III mandate. To ensure Phase III clinical trial enrollment as quickly as possible, we're adding substantially more clinical trial sites, way above the number used to conduct the U.S.-only Phase II trials. We're now finalizing costs and timelines, and our plan is to conduct the required two Phase III registration trials consecutively, not concurrently, given the size of our company and need to use our financial resources most efficiently. The timeline to conduct our Phase III trials is not a concern, since I've as opposed that we'll have a rolling 10 years of regulatory exclusivity in the U.S. from the date of the FDA approval. with similar exclusivity available in Europe, the UK, Japan, and Canada. We will continue to seek a strategic transaction for the company, including a potential partnership for the further development and potential commercialization of Ivesa Polestat, alongside preparation for phase three in our build-up strategy. At this time, we have no commitments from potential partners or others to report But now having FDA confirmation of the registration plan, this has become an active initiative. As we've consistently reported, Ibenzapulstat clinical results continue to outperform in a serious and potentially life-threatening infection. The CDC categorizes C. difficile as an urgent threat and calls for new classes of antibiotics for initial treatment that also have a low incidence of recurrence. Ibezapulsa is also FDA fast-track designated for the treatment of C. difficile infection. Initially, we believe Ibezapulsa, if approved, could make a favorable impact by reducing the cost burden of recurrent C. diff infection on the U.S. healthcare system, which is estimated at $4.7 billion annually. We do believe the best is yet to come. And now back to our CFO, Rob Schauer, to guide you through the highlights of our financial results for the first quarter.
spk01: Rob? Thanks, Dave. Our financial results for the first quarter ended March 31, 2024, were included in our press release issued earlier this morning. The company ended the quarter with cash totaling $8.9 million, compared to $7.5 million as of December 31, 2023. During the first quarter, the company sold an additional 1,121,793 shares under its ATM financing program with gross proceeds of approximately $4.4 million. Research and development expenses for the three months ended March 31, 2024 were $1.6 million compared to $1 million for the three months ended March 31, 2023. The increase was due primarily to an increase in manufacturing-related costs during the quarter. General and administrative expenses for the three months ended March 31, 2024 were $2.8 million, compared to $1.9 million for the three months ended March 31, 2023. The increase was due primarily to a $.7 million increase in professional fees and a $.2 million increase in non-cash share-based compensation. The company reported a net loss of $4.4 million, or 28 cents, per diluted share for the three months ended March 31, 2024, compared to a net loss of $2.9 million, or 25 cents, per diluted share for the three months ended March 31, 2023, all for the reasons we previously mentioned. The company had 15,757,102 shares outstanding as of March 31, 2024. With that, I'll turn the call back over to Dave.
spk04: Dave? Thanks, Rob, and thanks to all of you for joining us today. I'll now ask Bob DeLucci, our executive chairman, who managed the FDA post-Phase II meeting process, to provide his perspective on the FDA meeting in the company's phase three mandate. Bob?
spk06: Yeah, thanks, Dave. So let me just add a few thoughts on top of Dave's comments about our end of phase two meeting with the FDA. In general, it was a very thorough, productive, and successful meeting regarding four things. First, we had overall agreement that was reached based upon the strength of our preclinical and phase two clinical trial results. including the anticipated safety database, we're ready to move forward with plans for our Phase III program. Second, with respect to the Phase III clinical trial design, as expected, it'll be the same design as our Phase IIb trial, which is non-inferiority to vancomycin, with the primary endpoint being clinical cure after 10 days of treatment and a secondary endpoint of sustained clinical cure about 30 days after the end of treatment. Third, we agreed on the statistical analysis patient population, which will be a modified intent to treat, or what's called MITT population, with an estimated 450 subjects in that MITT group. And this is roughly what we had expected and will now be in sync with requirements for an EMA clinical trial authorization. And lastly, agreement on the registration program for two non-inferiority trials versus vancomycin, which would be required for marketing approval. Now, I'd also add that we were very pleased with suggestions from the FDA, including ultimate labeling and overall supportive tone of the FDA from our submitted data to date and our plan going forward. Bottom line, we now have a complete regulatory roadmap to move forward with our Phase III program, which is the last clinical development step toward marketing registration of Ibex PulseNet globally. For a small entrepreneurial company like Acurex, this is a very significant milestone that we've reached. And, Dave, if you don't mind, I'd like to add one more thing, just on top of what you said. Recall that Ibex PulseNet has FDA fast-track designated status. due to the urgent need classification by the U.S. CDC for new classes of antibiotics. And there are similar classifications like this available in other geographies, including Europe, the U.K., Japan, and Canada. If approved, Ibezapolstat will be the first new class of antibiotics brought to the market in over three decades. So we've got no time to waste to get this new product over the goal line. And with the continued support of all our shareholders, we have a clear vision and a strong passion to be successful for the ultimate benefit of patients who need better treatments for C. difficile infection, and all our stakeholders, and in general, for better public health. Kevin?
spk02: Thank you. We're now conducting a question and answer session. If you'd like to be placed in the question queue, please press star 1 on your telephone keypad. A confirmation tone will indicate your line is in the question queue. You may press star two if you'd like to remove your question from the queue. One moment, please, while we poll for questions. Our first question today is coming at us from H.D. Wainwright. Your line is now live.
spk00: Great. Thanks for taking our questions. And, Bob, I appreciate the comments at the end. Those were some of the questions I had regarding questions the specifics around the trial. A couple of follow-ups there. Firstly, the 450 patients or subjects that you mentioned, is that the total number for the trial? And also the usual requirement from the FDA of two well-designed pivotal studies. I want to just confirm that the Phase IIb is being considered as one of those two, and so this upcoming trial would be the final study. Secondly, I wanted to ask about the costs and timelines. I know that you said that those are currently being finalized, but any preliminary or early around those would be helpful for us. And then lastly, around this, the strategic partners and your efforts now that you've characterized as being active now that you have a pathway for a pivotal study, I'm wondering, although you don't have any current commitments, do you have any active discussions at this point? Thanks so much.
spk04: Thank you for your questions, Ed. The last question being the easiest, I'll hit that one first. So we have active discussions, several active discussions at the moment. Nothing to report. But, for example, the company will be well represented at the BIO CEO conference in San Diego. And my schedule is chock full. So there's a lot of activity. Um, we felt it most appropriate, uh, before making outbound calls, uh, to have the FDA piece to the puzzle in place, uh, because we now are truly phase three ready and that removes another piece of the puzzle in terms of things, uh, being set, set in stone. So that's all set. Um, On the first question, with regard to the 450 MITT patients, that's the total MITT patients for each of two Phase III registration trials, Phase III registration trials. So the Phase IIb is not considered a registration trial. You may recall the small numbers of patients, and quite frankly, we needed a lot more patients to have uh, satisfactory safety database, uh, for an NDA application thereafter. So it's 450 patients MITT, uh, for each of two trials for a total of 900. Um, and, um, to your question, we are still going through the costings, so we don't know exactly how much it will cost. Um, and in some cases if we have a partnership, uh, It may be that some of the work that we would have paid for would be internalized by, you know, a fully integrated pharma company that will be, you know, side by side with us with mutual interest to get the phase three program done as quickly as possible. And using our phase three data for filing in Europe, the UK, Japan. So the MITT piece to the puzzle was a quick conversation with the FDA. head because really you need that to get to file for approval in Europe and the UK. So by agreeing on that particular point, um, we were able to avoid further clinical trials beyond the two phase threes. And quite literally we have, uh, you know, an equal pathway in the U S the UK and Europe. Um, so, so we're kind of delighted with that piece to the puzzle. Um, But that's, I think that's, is there another piece to your question that I may have missed?
spk06: I think Dave, yeah, Dave, a question on timeline. I mean, I can answer it if you'd like to.
spk04: Oh, the timeline. Yeah, we feel, based on what we've specced out so far, that it would be a year and a half to two years from first patient enrolled.
spk06: Okay. And, Ed, this is Bob. Just to reiterate, too, the two phase three trials are straightforward from the FDA guidelines, the October 22, I think it was, guidelines. And that's a very clear path for what's needed for approval and an NDA.
spk00: Got it. Thank you so much. Appreciate it.
spk02: Thank you. As a reminder, that's star one to be placed in the question queue. Our next question is coming from Mike Lloyd, a private investor. Your line is now live.
spk03: Good morning, gentlemen, and thank you for the update. It's very exciting. I can't wait to see the next steps. Quick question, easy one, I hope. Has the company considered a priority review voucher for this application? Thank you.
spk04: Thanks for the question, Mike. Bob, do you want to hit that one?
spk06: Yeah. I mean, we already have priority review because of our FDA fast track status. So we already have that.
spk03: Yeah, but the voucher itself is actually, there's value to that. You could actually sell that if you chose. Current market value is about $100 million. So looking at that as, you know, a source of possible funding at some point.
spk04: We can certainly take a look.
spk03: Yeah. Okay, cool. I mean, the timing is right to begin thinking about it. It's associated with the NBA. So it's time to put it on the radar if it's something that the FDA would consider.
spk02: Okay. Thank you. Our next question today is coming from James Malloy from Alliance Global Partners. Your line is now live.
spk05: Hey, good morning, guys. Thanks for taking my question. I apologize if I missed it on the call. Did you guys... state when you anticipate starting the first of the two Phase 3s, and can you walk us through what the all-in costs on the Phase 3s are anticipated?
spk04: Thanks, Jim, and good morning. We hope to start, we'll be ready to start in the fourth quarter of this year with enrollment with our manufacturing update that we recently received. So we hope to be funded satisfactorily by then in order to start. So that's the gating factor. But yeah, we hope to start in the fourth quarter and then enrollment should take 18 to 24 months. And it's difficult for us to guesstimate exactly how much this is going to cost because we have a lot of partnering discussions currently ongoing and they're all different. And they all have various internal capabilities that dramatically impact what the Phase 3 mandate will cost. It's certainly, you know, something in the $50 to $60 million range if we were to do it all independently ourselves. So a partnership would be an appropriate course.
spk05: How would you characterize the current partnership environment? And obviously, after Phase 3 is your best deal, you're obviously not there. But how do you characterize sort of the going into phase three, the partnership opportunities you're seeing?
spk04: You know, I would characterize it as pretty robust. I mean, probably my last 20 emails in my inbox are people wanting to meet me, and I haven't even looked at the emails yet. That's just from overnight. I mean, it's just a lot of interest. And, you know, we may not be enrolling in phase three, but we're phase three ready. And we know we have a drug from our phase two B data. So, you know, we have to be patient and we have to take the right deal. And, you know, when things come along that are going to, you know, constitute, you know, 60% of the company being lost to a round of investment, you know, then, you know, sometimes it's the deals that you don't do that make the most sense. So we're trying to be judicious about, raising capital as non-dilutably as possible, knowing that we have a drug and that we're phase three ready. And there aren't a lot of phase three antibiotics out there right now, especially not in a billion dollar plus market where you have, you know, a reasonable chance to be frontline therapy.
spk05: Actually, maybe last questions on my end. On the design, I know that obviously a year, year and a half to get to run the first of the phase threes. Is there any opportunity for any interim looks and any thoughts on timing on that? And then any update on the Pasteur Act? What's going on?
spk04: You know, I'll leave the question on the Pasteur Act. I'll leave to Bob. There's some new legislation, actually old legislation that may be expanded to include antibiotics that treat life-threatening infections. Katie Britt in the Senate has gotten in touch with Health and Human Resources about, but I'll let Bob talk about that. But the interim look thing, that's kind of like a head fake. I know it's NBA playoff time, so for you NBA fans, the interim look, that would go through an independent committee of scientists and doctors, and if you take an interim look you necessarily statistically have to add patients to the trial. And the interim look doesn't give you any sense of percentage-wise, how you're doing with the primary endpoint or the secondary endpoints. All it does is this group of experts tell you to either keep going or to stop due to futility. So for the amount of information you get out of that, To me, it's not worth, you know, adding, you know, millions of dollars in time to a trial.
spk06: Yeah, I agree. I agree with you, Dave, on that for sure. And hope that answers the question. But remember, this is a blinded trial. So you really cannot break the blind if you're going to continue to proceed. About the second, I think there was a second question there regarding.
spk04: It was about Pastor. Yes.
spk06: What was the question?
spk04: What's going on with the Pasteur Act?
spk06: Yeah, Pasteur, you know, there's a lot of effort to try to get that through. We're really unlikely going to occur this year under the current political environment. However, there is some activity with a special program that requires a drug to be determined as a material threat. in order to get some additional funding from a government organization called BARDA for new classes of antibiotics that are in late-stage clinical trials, namely Phase 3. So this is being circulated as pending legislation, trying to move it forward this year. I wouldn't put a high probability that it's going to get through this year, but if it does, we'll be able to tap into that for some partial funding for our Phase 3 program.
spk04: You know, actually, just a slight nuance on that is that the legislation is actually old. It's been approved a long time ago. So what would need to happen is that the scope of the program would need to be expanded, which I understand can be done by HHS on their own. It would need to be expanded to include antimicrobials that treat life-threatening infections. So it doesn't rise to the level of needing a new law. The law is there. It's just the program needs to be expanded to include this new class of things that ultimately will be stockpiled by the federal government through the Department of Defense.
spk05: Yeah. Thank you for taking my questions.
spk02: Thank you, Jim. Thank you. We've reached the end of our question and answer session. I'd like to turn the floor back over for any further or closing comments.
spk04: We'd just like to thank everyone for participating today, and thank you for your patience, and the best is yet to come.
spk02: Thank you. That does conclude today's teleconference. You may disconnect your line at this time, and have a wonderful day. We thank you for your participation today.
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