Acurx Pharmaceuticals Q1 2025 Earnings Call Transcript

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May 13, 2025

There are 3 speakers on the call.

Operator

Greetings, and welcome to the Accurix Pharmaceuticals First Quarter twenty twenty five Financial Results and Business Update. At this time, all participants are in a listen only mode. A question and answer session will follow the formal presentation. As a reminder, this conference is being recorded. I would now like to turn the call over to your host, Rob Shala, Chief Financial Officer of Accurix Pharmaceuticals.

Operator

Thank you. You may begin.

Speaker 1

Thank you, Melissa. Good morning, and welcome to our call. This morning, we issued a press release providing financial results and company highlights for the first quarter twenty twenty five, which is available on our website at accurexpharma.com. Joining me today is David Luci, President and CEO of Accurex, who will give a corporate update and outlook. Following that, I'll provide some highlights of the financials from the first quarter ended March 31, and then turn the call back over to Dave for his closing remarks.

Speaker 1

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 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 with the Securities and Exchange Commission, including our quarterly report on Form 10 Q, which we filed yesterday, Monday, 05/12/2025. You are cautioned not to place undue reliance on these forward looking statements, and AcuRx disclaims any obligation to update such statements at any time in the future. This conference call contains time sensitive information that's accurate only as of the date of this live broadcast, today, 05/13/2025. I'll now turn the call over to Dave Lucci.

Speaker 1

Dave? Thanks, Rob. Good morning, everyone, and thank you so much for joining us to review our financial results for the first quarter of twenty twenty five and to hear some recent updates, then we'd be pleased to take any questions. First, I'd like to briefly summarize just a few of our key activities for the first quarter twenty twenty five or in some cases shortly thereafter. In January, we announced that we closed a $2,500,000 registered direct offering priced at the market under NASDAQ rules.

Speaker 1

Also in January, we announced that we received positive regulatory guidance from the European Medicines Agency for the adezafulstat Phase III clinical trial program, which is aligned with FDA on matters of manufacturing, nonclinical and clinical aspects of the Phase III program. The EMA guidance also confirmed that there's a full test regulatory pathway for a marketing authorization application to be filed by the company after successfully completing Phase III clinical trials. With mutually consistent feedback from both EMA and FDA, Aparex is well positioned to commence our international Phase III registration program. In February and March, we announced a new publication in the Journal of Antimicrobial Agents and Chemotherapeutics of two very important nonclinical studies, which we believe can leverage we can leverage to show further positive differentiation for competitive advantage of ibezafolstat versus all other antibiotics used for first line therapy to treat C. Difficile infection or CDI.

Speaker 1

And for that matter, given our clinical results to date, we anticipate that this anti recurrence effect of vezepulstat could mitigate the patient's need for expensive microbiome therapeutic agents to prevent recurrent C. Diff. Specifically, in February, we announced positive results from the first study conducted by doctor Justin McPherson from University of Houston and funded by the National Institute of Allergy and Infectious Disease. It was an in silico study that predicted the microbiome resources potential of ibezafolcept for treating C. Diff.

Speaker 1

Our scientific advisers consider this to be a major finding which provides a mechanistic explanation for ibezaprolol's cell activity and that the predicted bacteria bacteria interaction between ibezaprolol's cell and its target, the FAL3C enzyme, allows regrowth of gut microbes known to prefer health benefits. The second study conducted by doctor Trenton Wolf from the University of Montana was funded by the National Institute of Allergy and Infectious Disease, the National Cancer Institute, National Center for Advancing Translational Science and Access. This study is the first head to head comparison of changes associated with isexafolstat when compared to other anti CDI antibiotics in a germ free mouse model. The data show that changes in alpha and beta microbiome diversities following idezafilstat treatment were less pronounced compared to those observed in vancomycin or metronidazole treated groups, complementing prior phase two clinical findings showing idezafilstat more selective antibacterial activity. Further and very important and and very importantly, notable differences were observed between the microbiome of the ibezafil and adaxamycin treatment groups, which may allow for differentiation of these two anti CDI antibiotics in future studies.

Speaker 1

These results establish idezepulstat differentiating effects on the gut microbiome, indicating a more selective spectrum of microbiome alteration compared to a broad spectrum antibiotics like vancomycin and metronidazole and narrower spectrum microbiome alteration compared to phenaxomicin. Also in February, the Japanese patent office granted a new patent for our DNA IL-3C inhibitors, which expired in 02/1939 subject to extension. This constitutes a significant building block for our ongoing development of ATX three seventy five, our preclinical antibiotic program targeting the treatment of infections caused by medicillin resistant staph, randomized and resistant, and anthrax. In March, we announced the closing of a registered direct offering and concurrent private placement raising gross proceeds of 1,100,000.0. And just last month, the Indian patent office granted a new patent for our DNA POL3C inhibitors, which expires in December 2039 subject to extension.

Speaker 1

This constitutes another significant building block for our ongoing preclinical antibiotic development program of ATX three seventy five, which targets the treatment of MRSA, VRE, and anthrax infections. And just last week, May 8, we closed an equity line of credit with Lincoln Park Capital for up to $12,000,000 of additional funding. Looking forward to the weeks ahead, I can share with you that our outstanding phase two clinical trial data has been accepted for publication in the premier medical journal Lancet Micro and is now in press to be published shortly and summarizes abezoprolol test phase two results as follows. And I quote, results included high rates of clinical cure in ibezopolitan treated subjects with no recurrence. Furthermore, ibezopolitan was found to be safe, well tolerated, and associated with the preservation of key health promoting bacteria responsible for bile acid homeostasis, a key component in preventing recurrent c CDI.

Speaker 1

The publication establishes that bezaflofen's potential as a novel antibiotic treatment for CDI with high rates of clinical cure and sustained clinical cure while minimally disturbing the protective gut microbiota. The senior author, professor Kevin Garry, University of Houston, and the coauthor of the IDSA treatment guidelines for TDI, noted that current US and European treatment guidelines for TDI recommend only two antibiotics, oral vancomycin or vancomycin. Vancomycin is is most commonly used, but it has a low clinical cure rate of seventy to ninety two percent and a sustained cure rate of just forty two to seventy one percent. Fadazomycin has fewer recurrences, but low rates of clinical cure, eighty four percent, and sustained clinical cure, sixty seven percent. Doctor Gary further notes that both antibiotics are associated with emerging anti microbial resistance, stating, quote unquote, the clinical need for a new antibiotic like isisotopept to treat TDI is understood by a recently published study in clinical infectious disease by doctor Chris Danske of the team of VA and conducted a hospital setting documented that c difficile isolates with clinically relevant reduced fadacitamide susceptibility may emerge during therapy and spread to other patients.

Speaker 1

The medical community should be aware of this alarming finding, end quote. Also, upcoming, regarding Atherex's overall DNA IL-three t inhibitor platform, it's a scientific presentation to be given on May 21 by doctor Nia Uran from Leiden University Medical Center in The Netherlands entitled, a unique inhibitor confirmation selectively targets the DNA policy policy of gram positive priority pathogens. This scientific conference is sponsored by the Federation of American Society for Experimental Biology and is the premier venue for the newest research and technological trends in molecular machines inside the human body that ensure DNA replication and expression of genes to create proteins that make up the cell. We continue to identify and pursue funding opportunities for our Phase III advezipolstat clinical trial program. We have several initiatives underway to that end, and we hope to have something to report in future updates.

Speaker 1

As we continually reported, advezipol's medical results continue to outperform in a series of potentially life threatening infectious disease caused by c difficile bacteria 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 like ibezafolzat. Ibezafilstat has FDA QIDP and fast track designations for the treatment of CDI. We also believe that ibezafilstat, if approved, could make a favorable economic impact by reducing the overall annual US cost burden for C. Diff infection, which is $5,000,000,000 per year, of which 2,800,000,000.0 is due to recurrent infection. With our continuing momentum and passion to achieve success for our stakeholders, we remain confident that the best is yet to come as we plow through these very challenging times in the macroeconomic environment and in our industry sector.

Speaker 1

And now back to our CFO, Rob Shallow, to guide you through the highlights of our financial results for the February. Rob? Thanks, Dave. Our financial results for the first quarter ended 03/31/2025 were included in our press release issued earlier this morning. The company ended the quarter with cash totaling $4,600,000 compared to $3,700,000 as of 12/31/2024.

Speaker 1

The company raised a total of approximately 3,600,000 of gross proceeds through two registered direct offerings during the quarter. Research and development expenses for the three months ended March 31 were $600,000 compared to $1,600,000 for the three months ended 03/31/2024, a decrease of $1,000,000. The decrease is primarily due to a decrease in manufacturing costs of $400,000 and a decrease in consulting costs of $600,000 as a result of the prior year trial related expenses. General and administrative expenses for the three months ended 03/31/2025 were $1,600,000 compared to $2,800,000 for the three months ended 03/31/2024, a decrease of $1,200,000. The decrease was primarily due to point $700,000 decrease in professional fees resulting from lower consulting expenses and a $600,000 decrease in share based compensation costs.

Speaker 1

The company reported a net loss of $2,100,000 or 11¢ per diluted share for the three months ended 03/31/2025, compared to a net loss of $4,400,000 or $0.28 per diluted share for the three months ended 03/31/2024, all for the reasons previously mentioned. The company had 22,397,511 shares outstanding as of 03/31/2025. With that, I'll turn the call back over to Dave. Thanks, Rob, and to all of you for joining us today. I'll now turn the call over to Melissa, our operator, to open the call for questions.

Speaker 1

Melissa?

Operator

Thank you. Our first question comes from the line of Jason McCarthy with The Maxim Group. Please proceed with your question. Hi, good morning. This is Joanne Lee on for Jason McCarthy.

Operator

Thanks for taking our question. Just one for me regarding the recent publication highlighting IBA's selective activity and potential microbiome preserving effects. I'm just curious if the company plans to explore this further and if the complementary findings are informing the Phase three trial in any way. Are you considering incorporating microbiome related endpoints to help reinforce IV I'd be the differentiation in the CDI space? Thanks.

Speaker 1

Thank you very much, Joanne. Yes. We are indeed exploring this actively. It's it's already been preservation and restoration is already a secondary endpoint in the phase three program design as an advent of phase two b. But we're exploring it nonetheless.

Speaker 1

We're seeing that this is an area of differentiation, which is one of the primary reasons we believe that we're seeing so distinctively less recurrent C. Diff than is experienced by patients on other antibiotics. And, you know, with the new administration in Washington and Marty Makary, you know, I believe, you know, we're reading the key leaves and exploring other possibilities in terms of pathway to approval. We'll look at more on that on the next call, but, you know, that that's currently a hot topic internally.

Operator

Great. That was helpful. Looking forward to seeing how things progress.

Speaker 1

Thank you so much.

Operator

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

Speaker 2

quick looking at sort of G and A and R and D and OpEx, I guess, the quarter. These are levels we should expect going forward. I see that R and D has been coming up pretty dramatically. I know you've been waiting to get the Phase three start. It'll ramp up as a new ramp up, you know, once that gets going.

Speaker 2

Any thoughts on on the on the trajectory of that through 2025? Any updates on sort of the expected start date of any potential phase three?

Speaker 1

Thanks so much, Jim. I appreciate the questions. You know, I I can hop in here. We've done some dramatic cross cutting that started in the February and will continue. So I would expect our both our g and a and our r and d cost to continue to go down as quarters go by until we start the phase three program.

Speaker 1

I don't wanna provide a hypothetical date for the start of phase three because we don't have the funding yet. And, you know, since we don't make the decision on on the other side of where that funding is coming from, it's kinda hard to project. But we do have a lot of irons in the fire. We did close out an equity line of 12,000,000 with Lincoln Park Capital last week. So we feel that we are in decent position relative to, you know, other biotech companies.

Speaker 1

It's kinda tread water until one of these funding opportunities comes through.

Speaker 2

I just know you guys have been excellent stewards of shareholder capital. One notably, the accruals are always in good shape, Robert. As you look at the any updates on the past due act and what may be going on there?

Speaker 1

We we don't have anything specific on the past due act. Although, you know, I'm in touch with our lobby group probably a half dozen times a day, and things in Washington are are frenetically busy, notably of recent vintage drug pricing reductions, which in a trade way, I think, help our little company as compared to big pharma. But nothing specific on the Paxdorak or I think we talked before about Paxdorak Light, but it's still out there. There's also traditional bar grants that may become available. And for the second program, we recently put in an application to ARPA h.

Speaker 1

So Oh, okay. And there's a European FDA type group that has taken some interest. So there's a lot we've got a lot lines in the water, so to speak, for anyone who's a fisherman, like, the Cape Cod area like yourself. We got lines in the water, and we're just we're just waiting to to get a buddy.

Speaker 2

That's understood. And last question, Margaret Carrier had some comments about sort of the ultra rare path for approvals based on plausible mechanisms rather than in actual clinical trials. That wouldn't apply to you guys, though. Right?

Speaker 1

You know, it's so funny. I mean, Joanne had a good question before. You know, it's a great question. It's right on point with, you know, something that's being discussed internally right now based on Marty Makary's comments. So it it may apply to us.

Speaker 1

It would be a first for an antibiotic for an antibiotic to follow that pathway, but I've tried to proceed. We're taking a look.

Speaker 2

Telling her to look. Absolutely. Oh, thank you guys very much for taking the questions.

Speaker 1

Thanks so much, Ken. Thank you.

Operator

You. Ladies and gentlemen, this concludes our question and answer session, and thus concludes our call today. We thank you for your interest and participation. You may now disconnect your lines.

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Earnings Conference Call
Acurx Pharmaceuticals Q1 2025
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