Q4 2024 Acurx Pharmaceuticals Inc Earnings Call
Greetings and welcome to the Acurx Pharmaceuticals, fourth quarter and full year 2024 financial results and business update. At this time all participants are no listen only mode, a question and answer session will follow the formal presentation.
Speaker Change: If anyone should require operator assistance during the conference, please press star zero on your telephone keypad. As a reminder, this conference is being recorded. I'll now turn the conference over to your host, Mr. Rob Shawah, Chief Financial Officer for Acurx Pharmaceuticals. Please go ahead, sir.
Thank you, Melissa. Good morning, and welcome to our call.
Speaker Change: Joining me today is Dave Lucci, President and CEO of Acurx.
We'll give a quarter update in Outlook.
Speaker Change: Following that, I'll provide some highlights to the financials from the fourth quarter and full year ended December 31, 2024, and then turn the call back over to Dave for his closing remarks.
Speaker Change: As a reminder, during today's call, we'll be making certain forward-looking statements, which are based on current information, assumptions, estimates, and projections about future events.
Speaker Change: that are subject to change and involve a number of risks and uncertainties.
Speaker Change: that may cause actual results to differ materially from those contained in the forward-looking statements.
Speaker Change: Investors should consider these risks and other information described in our filings with the Securities and Exchange Commission.
Speaker Change: including our annual report on Form 10K, which we filed yesterday, Monday, March 17th, 2025.
Speaker Change: Your caution not to place undue reliance on these forward looking statements.
Speaker Change: An Acurx disclaims any obligation to update such statements at any time in the future.
Speaker Change: This conference call contains time-sensitive information that's accurate only as of the date of this live broadcast today, March 18, 2025.
I'll now turn the call over to Dave Luci, Dave.
Speaker Change: Thanks Rob. Good morning everyone and thank you so much for joining us to review our financial results for the fourth quarter in full year 2024 and also to hear some recent updates.
Then we'd be pleased to take any questions.
Speaker Change: on it for the treatment of seed difficile infection into international Phase III clinical trials.
Speaker Change: We believe that if successful, this last set of clinical trials to complete will be pivotal to form the basis for our new drug application in the US and marketing authorization application for the European Union.
Speaker Change: In October 24, we exhibited an ID week in Los Angeles.
Speaker Change: which was the annual scientific conference of the Infectious Disease Society of America, where doctors Gary and you bagged from the University of Houston School Pharmacy.
Speaker Change: presented a scientific poster showing that in our face-to-be clinical trial, I bet it's at comparable clinical cure and sustained clinical cure rates and safety profile to bechromycin.
Speaker Change: As previously reported, the overall observed clinical fury in a combined phase two trials.
Speaker Change: Phase 2A and Phase 2B, in patients with CDI, was 96%, 25 out of 26 patients.
Speaker Change: and importantly 100% or 25% or 25% of the IBES treated patients in the Phase 2 program.
Speaker Change: who had clinical cure at the end of treatment remains cured through one month after EOT, as compared to just 86 percent, 12 of 14 patients.
in the vagal mice and treatment arm in phase 2b.
Speaker Change: Also, on a subset of my BESA post at patients, 5-5 follow-up for three months after the end of treatment, experience no recurrence of infection.
Speaker Change: I best treated patients show decreased concentration of fecal primary bile acids and higher ratios of secondary to primary bile acids than vagomycin treated patients.
Dr. Gary: According to Dr. Gary, these exciting results demonstrate two properties of Ibiza Post Act which making tribute to its anti-recurrentice act.
Dr. Gary: First, the preservation and restoration of beneficial bacteria classes in the gut provided resistance to recolonization by C. difficile.
Dr. Gary: Second, these data presented for the first time indicate that these beneficial bacteria and known to metabolize primary to secondary pylasids persist in eye-physiposa treated patients, providing another important mechanism to prevent recurrent CDI.
Dr. Gary: In November last year, we announced sponsorship and participation in the inaugural Peggy Lillist Foundation, CDI Scientific Symposium, and presented an eye-vehicle that faced to the clinical data update.
Dr. Gary: In January 25th, the company announced that it closed the $2.5 million registered direct offer and priced at the market under now as that rules.
Dr. Gary: Also, in January 25, we announced that we received positive regulatory guidance from the European Medicines Agency for the IPH as a poll set, Phase III clinical trial program.
Dr. Gary: Which guidance is aligned with FDA on matters of manufacturing, non-clinical and clinical aspects of the Phase 3 program?
Dr. Gary: The EMA guidance also confirmed, I've as opposed to that's regulatory pathway, for our marketing authorization, application to be filed.
Dr. Gary: By the company, after a successful completion of the Phase 3 clinical trials,
Dr. Gary: So now with Mutually Consisted Feedback for both the EMA and FDA, Acurx is well positioned to commence our International Phase III Registration Program.
Dr. Gary: This past February and just this month, we announced new publications in the Journal of Antimicrobial Agents and Chemo-Ferracutics of two very important non-clinical studies which we believe can leverage to show further positive differentiation.
Dr. Gary: for Competitive Advantage of I-Benz, as compared with all other antibiotics used for frontline therapy to treat significant seal infection.
Dr. Gary: And for that matter, given our clinical results today, we're hopeful that this anti-recurrents effect of eye beds could mitigate the need for expensive microbiome therapeutic agents to prevent recurrence in the eye.
Dr. Gary: In February , we announced positive results from this first study conducted by Dr. Justin McPherson from the University of Houston and funded by the Natural Institute of Biology and infectious diseases for NIAID.
Dr. Gary: It was an Encilical study that predicted the microbiome, restorative potential of IVAS, retreating
Dr. Gary: Our scientific advisor has considered this to be a major fighting, which provides a mechanistic explanation.
Dr. Gary: or I've had a full set selectivity in that the predicted bacteria and cytol interaction between I-Bez and its target, the DNA-PAL-3CM zone, allows regrowth of gut microbes known to convert health benefits.
Speaker Change: The second study conducted by Dr. Trenton Wolf from the University of Montana was funded by NIAID, the National Cancer Institute, National Center for Advancing Translational Sciences, and the company.
Speaker Change: The second study is the first ever head-to-head comparison of gut microbiome changes associated with IBES, when compared to other anti-CDI antibiotics in a journey-free mouse model.
Speaker Change: The data showed that changes in alpha and beta microbiome diversities following eye-by-streatment were less pronounced compared to those observed in macromycin or metronidazole treaty groups.
Speaker Change: Complan, I think, prior phase two findings, showing I, like, as a full sense, more selective anti-bacterial activity.
Speaker Change: Further and very importantly, notable differences were observed between the microbiome of a
and the Phidaxomycin-Treaty Groups.
Speaker Change: which may allow for differentiations of these two anti-CDI, antibiotics, and future studies.
Speaker Change: These results establish, I bet, a close that's differentiating effects on the gut microbiome, indicating a more selective spectrum of microbiome alteration compared to broader spectrum antibiotics, like vancomycin and metronisol, and a narrower spectrum of microbiome alterization compared to vanachromycin.
Speaker Change: Also on February 25 last month the Japanese Patent Office granted a new patent for our DNA polymerase 3C inhibitors which expires in December 2039 subject to extension.
Speaker Change: This constitutes a significant building block for our ongoing development of ACX-375C, our preclinical antibiotic entity targeting the treatment of MRSA, VRE, and anthrax infections.
Speaker Change: On March 10th, just a week ago, we announced the closing of our registered direct offering in concurrent private placement, raising gross proceeds of $1.1 million.
Speaker Change: We continue to identify and pursue funding opportunities for our Phase 3 clinical trial program. We have several initiatives underway to that end, and hope to have something to report in future updates.
Speaker Change: So now we've got even more momentum going into 2025 at the end.
Speaker Change: As we've continually reported, our less clinical results continue to outperform in a serious and potentially life-threatening infectious disease.
caused by a seat of a sealed bacteria.
Speaker Change: that the CDC categorizes as an urgent threat and calls for new classes of antibiotics for initial treatment that also have a low incidence of recurrence.
Speaker Change: From a regulatory perspective, FDA has granted IBES, QIDP and FastTrack designations for the treatment of C-difficial infection.
Speaker Change: We also believe that I'd better pull that if approved could make a favorable economic impact by reducing the overall annual cost burden in the US for seeded the seal infection.
Speaker Change: $5 billion annually of which $2.8 billion is due to recurrent infection.
Speaker Change: and that's what our data shows we may sell for.
Speaker Change: With our continuing momentum and passion to achieve success for our stakeholders, we do believe the best is yet to come.
Speaker Change: and now back to our CFO Rob Schallup to value through the highlights of our financial results for the fourth quarter in full year 2024.
Thank you. Bye.
Thanks, Dave.
Speaker Change: Our financial results for the fourth quarter and near end of December 31, 2024 were included at our press release issued earlier this morning.
The company ended the year with cash totaling $3.7 million.
compared to $7.5 million as of December 31, 2023.
Speaker Change: Under its ATM financing program for the year end of December 31, 2024.
Speaker Change: Research and Development Expenses for a three months end of December 31, 2024 for $0.8 million.
Speaker Change: Compared to $1.9 million for the three months end of December 31, 2023.
A decrease of $1.1M $1.1M.
Speaker Change: The decrease was primarily due to a decrease in consulting related costs at $1.2 million.
Offset by an increase in manufacturing costs
of 0.1 million dollars.
A decrease of $0.6M $0.2M
Speaker Change: The decrease was primarily due to a $1.6 million decrease in consulting related costs.
Speaker Change: Offset by a $1 million increase in manufacturing related costs.
Speaker Change: General and Administrative Expenses for the three months ended December 31, 2024. We're $2 million.
Speaker Change: Compared to $3.2 million for the three months ended December 31, 2023
A decrease of $1.2 million.
Speaker Change: The decrease is primarily due to a half-million-dollar decrease in professional fees.
and a $0.2 million decrease in employee compensation costs.
Speaker Change: For the year ended, December 31, 2024, General and administrative expenses were $8.7 million dollars compared to $8.5 million dollars for the year ended December 31, 2023.
An increase of $0.2M $0.2M.
Speaker Change: The increase is primarily due to a .7 million dollar increase in professional fees.
0.3 million dollar increase in legal fees.
Speaker Change: Offset by a $0.6 million decrease in share-based compensation costs
and a $0.2 million decrease in insurance costs.
[inaudible]
Speaker Change: The company reported a net loss of $2.8 million or $0.16 per diluted share for a three-month end of December 31.
2024
Speaker Change: Compared to a net loss of $5.1 million, or $0.37 per diluted share for three months ended, December 31, 2023.
and then that will have to $14.1 million.
Speaker Change: for $0.87 per year for the full year ended December 31, 2024.
Speaker Change: Compared to a net loss of $14.6 million or $1.15 per share for the year ended December 31, in 2023, all for the reasons previously mentioned.
Speaker Change: The company had $17 million, $30,686 shares outstanding as of December 31, 2024.
With that, I'll turn the call back over to Dave.
Dave Lucci: Thanks, Rob. And to all of you for joining us today, I'll now turn the call over to Melissa, our operator to open the call for questions.
Number X sir?
I'm sorry. I'm sorry. I'm sorry. I'm sorry. I'm sorry.
Speaker Change: Thank you. If you'd like to ask a question, please press star 1 under telephone keypad. A confirmation tone will indicate your line is in the question queue. You may press star 2 if you'd like to remove your question from the queue for participants using speaker equipment and may be necessary to pick up your handset before pressing the star keys.
Speaker Change: Our first question comes from the line of Ed Arce with HC Wainwright, please proceed with your question.
Speaker Change: Hello, good morning, everyone. This is Thomas Yip, asking a couple of questions for Ed. Thank you so much for taking our questions.
Thank you Thomas, good morning.
Speaker Change: Good morning. So first question for the Phase 3 program. Can you discuss some notable differences and also some similarities between what the FDA and the EMA are looking forward to the Phase 3?
Speaker Change: It's identical, Thomas. We're so fortunate in that regard. We waited in part of this strategy.
Speaker Change: We didn't go to the European Medicines Agency until we had cleared all of the non-clinical, n-manufacturing aspects.
Speaker Change: with the FDA. So, only with that in hand, we went with a final package to the Europeans, and it's identical protocol. There's completed agreement in all regards from both agencies.
Speaker Change: Okay, so in that vein, how do you envision the phase 3 program will enroll patients geographically? Will it be, you know, like a different split between the US and the EU or how do you envision to proceed?
Speaker Change: Well, subject to the normal adjustments that you may call in audibles along the way, we're going to start out with 150 clinical trial sites.
Speaker Change: and a full half of those sites will be in Europe . And the other half will be a combination of the U.S., Canada and South America.
Speaker Change: I guess you could say, by a plurality, it will be more European than American, maybe there will be 30% of the sites in the US compared to 50% of the sites in Europe .
That's it.
Speaker Change: I got it. And then moving on to additional data that you have been presenting, you know, either in conferences or publications. So, after this, Michael Pharmaceuticals study data, there will be a publishing last month. When should we expect more data with, it is supposed that this year.
That's a very poignant question. Thanks for asking.
There's a very prestigious scientific publication.
within which our full set of phase two data.
Speaker Change: will be included and published, and we think that will be sometime in the next 30 days.
Speaker Change: So that's the next one, but they appear periodically. There's continually more and more data coming out from what we've already done from the labs at the Houston College of Pharmacy and also up in Monterey.
Speaker Change: Okay, understood where we'll look forward to that. And then perhaps one final question from us. What options do you have available to fund development of 375 into the clinic?
Speaker Change: So, we haven't taken any options off the table, obviously we're continuing our multi-step approach to funding the company and...
Speaker Change: Most importantly, the Phase 3 trial. As I see it, with funding opportunities, I see the most
Speaker Change: Government Bias or quasi-government bodies, either in Europe or in the U.S.
Thank you.
So I think those aspects of-
you know, kind of our activities.
Speaker Change: are kind of in the forefront, at least for right now.
while we continue to pursue private partnerships.
and an M&A activity.
Speaker Change: that seems to be less active than the responses we're getting from...
Some of the government equates a government agencies.
I think that's because...
Speaker Change: Folks are recognizing as more and more of our data gets out there that we have a real drug that has a real need and not only would it be good for the public to have this available
Speaker Change: but it would be quite beneficial for the cost of public health because of the no recurrences.
and this too. But if I may just one one additional question actually.
Speaker Change: This one, your plan is still to look for a partnership, to move, it doesn't post that in case to read, or they had the option as well.
Speaker Change: Yes. I mean, we're looking for a partnership, but remember, we use the term partnership broadly to include a number of different agencies of the government, along with the pride et cetera. So it broads as yes, but that's still the plan.
Speaker Change: Ok, understood. Thank you so much for your questions. Thank you so much, Thomas.
Speaker Change: Thank you. Our next question comes from a line of James Molloy with Alliance Global Partners. Please proceed with your question.
Speaker Change: Good morning, thank you very much for taking my questions.
Speaker Change: Well, I was just wondering if you could characterize the partnership environment, and there was a lot of...
Speaker Change: A lot of turmoil in the market is that impacted your ability to secure partnerships with some being sequel happen in the 2025 time frame where this 2026 event and sort of if you have
Speaker Change: Perhaps that leads into the next question. When do you think you'll start the phase 3, but I'm guessing that depends quite a bit upon either a partnership or a funding event, right?
Speaker Change: Yes, I agree and I agree. The tumultuous nature of the things happening in the world today certainly present but even more keen challenge than we were facing coming into 25.
Speaker Change: But we feel that we're up for the challenge and we're going to continue the fight.
Thank you.
I do see potential partnerships with-
Speaker Change: you know, various groups throughout the world that are not pharmaceutical companies as being, you know, kind of further along at this point than private sector partnerships. But we're continuing on our efforts in both regards.
Thank you.
Speaker Change: I have been to Washington DC on Capitol Hill several times now.
and I can tell you at first hand.
Speaker Change: that everyone's looking over their shoulder down there right now, and...
Speaker Change: Yeah, it's a different vibe than I experienced when I was down in Capitol Hill back in September . So, hopefully things settle down over the next couple of months and...
Speaker Change: We can get down to some appropriations, but there are still appropriations from prior approvals, you know, government-approved programs.
Speaker Change: that were chasing down in one case of a flight war.
Speaker Change: So we're continuing the process. I think something will happen in 2025 that will allow us to start.
the face-to-reach trials within an enrollment.
Speaker Change: There may be a time lag between, you know, that event and the enrollment starting just because
Speaker Change: We don't want to make our Phil Finnish pill form until we're certain to have the money to start the trial.
because we don't want to date the packages.
Speaker Change: before we have to. So that's the final step, and that will take place after the money comes in. So that may present a few months, a time lag, between having the sufficient funding and starting the enrollment.
Speaker Change: Does that answer your question, Jim? It does indeed. I know there's a lot of uncertainty on these things, of course.
Jim: Should you get this trial started, what is the, what's the current expectation for soup to nuts, have a top-line day or an interim look?
Jim: What do you think that could occur? Should the trial start tomorrow?
Jim: Well, so the interim look, we decided against the interim look because statistically it adds like 10% to the required number of patients in the trial.
Jim: and it wouldn't really provide us anything other than an advisory committee would tell us.
Jim: You know, keeping rolling or, you know, futility. You know, we wouldn't be able to see any of the numbers. You know, if they ain't a double blind study, so we didn't do the interim look, but I think it will be two years from first patient enrolled to top line data.
Speaker Change: Alright, excellent. That wraps up my question. Thank you very much for taking it.
Excellent day. I hope you enjoyed your holiday yesterday.
Speaker Change: Could you have the calls, not on the day of the sink out of the deck?
Jason McCarthy, Wing Yip, Michael Okunewitch
Speaker Change: Thank you. Ladies and gentlemen as our reminder, if you'd like to join the question cue, please press star one on your telephone keypad.
Speaker Change: Our next question comes from the line of Claire H. Asin with Independent Investment Research. Please
Good morning, gentlemen.
Good afternoon, Claire.
Just a couple of things to remain.
Speaker Change: I just noticed that you've made mention of the suspension of the ATM program in January . I was just wondering if you could talk a little bit about what's happening there and then also if you could just comment on the risk with the NASDAQ listing given where the share price is currently trading.
Sure. So, we suspended.
Speaker Change: the ATM in connection with the offering that we were conducting in January . And we can put the ATM back in place and reactivated, so to speak, when the company management decides
So there's no prohibition on us, reactivating the ATM.
You know, it's currently not part of our-
Speaker Change: You know, I'm going plan which will unfold over the next several months.
Speaker Change: But, you know, with the, with the delisting, I can tell you, Claire, that there's...
You know...
No sense internally that we'll let the NASDAQ lift and go.
Speaker Change: And we're working on some things which we think will help with the listing in that regard. So we're leaving with us for now, but the last thing I would expect to see is for us to be traded out to Lisa Polka, we'll be right back.
Jason McCarthy, Wing Yip, Michael Okunewitch, James Molloy, Michael Okunewitch
Ok, so you're confident you'll be out to manage that.
Oh yes, absolutely.
Ok, great, thank you.
Thank you, player.
Speaker Change: Thank you. Ladies and gentlemen, this concludes our question and answer session, and we'll conclude our call today. We thank you for your interest in participation. You may now disconnect your lines.
Thank you very much. See you next time.