Acurx Pharmaceuticals, Inc.

And welcome to the Asterix Pharmaceuticals First Quarter 2025 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. 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 would now like to turn the call over to your host, Rob Schalla, Chief Financial Officer of Asterix Pharmaceuticals. Thank you. You may begin.

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 2025, which is available on our website at AsterixPharma.com. Joining me today is David Lucey, President and CEO of Asterix, who will give a corporate update and outlook. Following that, I'll provide some highlights of the financials from the first quarter and in March 31, and then turn the call back over to Dave for closing remarks. 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 in 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 10Q, which we filed yesterday, Monday, May 12, 2025. Your request should not replace undue reliance on these forward-looking statements and Asterix 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, May 13, 2025. I'll now turn the call over to Dave Lucey. Dave? Thanks, Rob. Good morning, everyone, and thank you so much for joining us to review our financial results for the first quarter of 2025. And if you have 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 2025, or in some cases, shortly thereafter. In January, we announced that we closed a $2.5 million -a-kid grass offering right at the market under HACF rules. Also in January, we announced that we received positive regulatory guidance from the European Medicines Agency for the Adventist Bulls' Test Phase III Clinical Care Program, which is aligned with FDA on matters of manufacturing non-clinical and clinical aspects of the Phase III program. The EMA guidance also confirmed that there's a Bulls' Test regulatory pathway for a marketing application to be filed by the company after successfully completing Phase III clinical trials. The mutually consistent feedback from both EMA and FDA acts as well positioned to promote international Phase III registration programs. In February and March, we announced new publications in the Journal of Antimicrobial Agents and Chemotherapeutists of two very important non-clinical creditors, which we believe can leverage to show further positive differentiation for contented advantages of that vector pulse test versus all other antibiotics used for first-line therapy to treat C-vapelis feldtsin or CDI. And for that matter, given our clinical results today, we anticipate that this anti-recurrence effect of that vector pulse test could mitigate the patient's need for expensive microbiome and therapeutic agents to promote recurrent C-vapes. Specifically, in February, we announced positive results from the first study conducted by Dr. Justin McPherson from the University of Houston and funded by the National Institute of Allergy and Infectious Disease. It was an -sci-lico study that predicted the microbiome resources potential of a vector pulse test for treating C-vapes. Our scientific advisers considered this to be the major finding, which provides a mechanistic explanation for a vector pulse test's selectivity in that the predicted exterior side will interact between a vector pulse test and its target, the palpate enzyme, allows regrowth of gut microbes known to confer health benefits. The second study conducted by Dr. Trenton Rowe 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 ACRES. This study preferred to estimate comparisons of gut and microbiome changes associated with I-dezapolskra, when compared to other anti-TBI antibiotics in a germ-free lifestyle. The data showed that changes in alpha and beta microbiome diversities following I-dezapolskra treatment were less pronounced compared to those observed in vancomycin or methamycin treated groups, complementing prior phase II clinical findings showing I-dezapolskra's more selective antibacterial activity. Further, and very importantly, notable differences were observed between the microbiome of the I-dezapolskra and paddexamycin treatment groups, which may allow for differentiation of these two anti-TBI antibiotics in future studies. These results established I-dezapolskra differentiating effects on the gut microbiome, indicating a more selective spectrum of microbiome alteration compared to a broad spectrum of antibiotics like vancomycin and methamyzo, and a narrow spectrum of microbiome alteration compared to paddexamycin. Also in February, the Japanese Pad and Office granted a new pad for our DMA-Pol3T inhibitors, which expired in 2039, subject to abstention. This constitutes a significant building block for our ongoing development of ACX375, our pre-clinical anti-TBI program, targeting the treatment of infections caused by medical and resistant staff, vancomycin-induced antialopiths, and antarachs. In March, we announced the closing of a registered narcooperative and concurrent pilot placement, raising gross proceeds of $1.1 million. And just last month, the Indian Pad and Office granted a new pad for our DMA-Pol3T inhibitors, which expired in December 2039, subject to abstention. This constitutes another significant building block for our ongoing pre-clinical antibiotic development program, ACX375, which targets the treatment of immersive URE and antarachs infections. And just last week, our Indian Pad and Office closed an equity line of credit with Lincoln Park Capital for up to $12 million of additional funding. Looking forward to the weeks ahead, I can share with you that our outstanding thank you clinical trial data has been attempted for publication in the Canadian Medical Journal, Lancet and Marquereau, and is now in press to be published shortly and summarized as our best of full steps for the future of the girls. As follows, and I quote, Results included high rates of clinical cure in a desophore fat-treated subject with no recurrence. Furthermore, a desophore fat was found to be safe, well-calorated, and associated with the preservation of teen health-promoting bacteria responsible for bioactive homeostasis, a teen component in preventing refrains from CDI. The publication establishes a best of full steps potential as a novel antiviral treatment for CDIs with high rates of clinical cure and sustained clinical cure, while minimally preserving the protective gut microbarata. The senior author, Professor Kevin Gerry, University of Houston and the co-author of the IUFA treatment guidelines for CDIs, noted that current U.S. and European treatment guidelines for CDIs recommend only two antibiotics, oral vancomycin or connexomycin. Vancomycin is most commonly used to have a low clinical cure rate of 70 to 92 percent and a sustained cure rate of just 42 to 71 percent. Connexomycin has fewer recurrences but low rates of clinical cure, 84 percent, and sustained clinical cure, 67 percent. Dr. Gerry further notes that associates of antibiotics are associated with emerging antihistorical resistance, stating what are the clinical needs for a new antibiotic like hypochondriac to treat CDIs are explored by a recently published study in clinical infectious disease by Dr. Craig Gonski of the Cleveland VA and conducted a hospital study, documenting that C. difficile icebergs with clinically relevant reduced to after-mycin susceptibility may emerge during therapy in spread to other patients. The medical community should be aware of this alarming finding. Also upcoming, regarding after-experimental overall DNA quality inhibitor class work, is a scientific presentation to be given on May 21 by Dr. Ina Urem from the University Medical Center in the Netherlands entitled, A Unique Inhibitor Confirmation Selectively Parties the DNA Policy of Grand Parasitic Priority Pathogens. This scientific conference is sponsored by the Federation of American Societies 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 three ABEZA Pulse App clinical trial program. We have several initiatives underway to that end and we hope to have something to report in future updates. As we continually reported, ABEZA Pulse App clinical results continue to outperform anterior and potential right threatening infectious disease caused by season of the field 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 ABEZA Pulse App. ABEZA Pulse App has FDA QIDC and fast track recommendations for the treatment of CDI. We also believe that ABEZA Pulse App is approved to make a favorable economic impact by reducing the overall annual U.S. cost burden for C. GRIP infection which is $5 billion per year of which $2.8 billion is due to recurrence 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. And now back to our CSO, Rob Schowler, to guide you through the highlights of our financial results for the first quarter of 2025.

Rob? Thanks Dave. Our financial

results for the first quarter and in March 31, 2025 were included in our tax release issued earlier this morning. The company ended the quarter with cash totaling $4.6 million compared to $3.7 million as of December 31, 2024. The company raised a total of approximately $3.6 million of gross proceeds through two registered direct offerings during the quarter. Research and development expenses for a three-month ended March 31 were $0.6 million compared to $1.6 million for a three-month ended March 31, 2024, a decrease of $1 million. The decrease is primarily due to a decrease in any fast-growing costs of $0.4 million and a decrease in consulting costs of $0.6 million as a result of the prior year trial related expenses. General and administrative expenses for a three-month ended March 31, 2025 were $1.6 million compared to $2.8 million for a three-month ended March 31, 2024, a decrease of $1.2 million. The decrease is primarily due to a $0.7 million decrease in professional fees resulting from lower consulting expenses and a $0.6 million decrease in share-based compensation costs. The company reported a net loss of $2.1 million or $0.11 per diluted share for the three-month ended March 31, 2025, compared to a net loss of $0.4 million or $0.28 per diluted share for a three-month ended March 31, 2024, all for the reasons previously mentioned. The company had ,397,511 shares outstanding as of March 31, 2025. With that, I'll turn the call back over to Dave. Dave Robb is to all of you for joining us today. I'll now turn the call over to Marica, our operator, to open the call for questions. Marica?

Thank you. If you'd like to ask a question, please press star one 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. For participants using speaker equipment, it may be necessary to pick up your handsets before pressing the star key. Our first question comes from the line of Jason McCarthy with the Maximus Group. Please proceed with your question.

Hi. Good morning. This is Joanne Leon for Jason McCarthy. Thanks for taking our question. Just one for me regarding the recent publications highlighting Ibeza's selected 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 Ibeza's differentiation in the CDI space?

Thanks. Thank you very much, Joanne. Yes, we are indeed exploring this actively. It's already the secondary endpoint in the phase three program design as it has been in phase two B. But we're exploring it nonetheless. 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-diss than is experienced by patients on other antibiotics. And with the new administration in Washington and Marty McCarey, I believe we're re-machining and exploring other possibilities in terms of pathway to approval. We'll look at more on that on the next call. But that's currently our topic internally.

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

Thank you so much.

Thank you. Again, as a reminder, it's star one to join the question queue. Our next question comes from James Malloy with Alliance Global Partners. Please proceed with your questions.

Hey, good morning, guys. Thanks for taking my questions. Just quick looking at GNA and R&D at OPAPS for the quarter. These are levels we expect going forward. I see that R&D's coming up pretty dramatically. I know you've been waiting to get the phase three started. As a team, it'll ramp up once that gets going. Any thoughts on the trajectory of that through 2025? Any updates on the expected start date of any particular phase three?

Thanks

so much, Jim. I appreciate the question. I can hop in here. We've done some dramatic thoughts that started in the first quarter of 2025 and will continue. I would expect our GNA and R&D class to continue to go down as quarters go by until we start the phase three program. I don't want to provide a hypothetical date for the start of phase three because we haven't had the funding yet. The situation makes a decision on the other side of where that funding is coming from. It's kind of hard to project, but we do have a lot of lines in the fire. We did close on the equity line of 12 million with Wicked Park Capital last week. We feel that we are in decent position relative to other biotech companies. It's kind of a tread water, so one of

these funding opportunities comes through. I understand. It has been excellent.

The screw is a fair of the capital. One notably accrued, who are always in good shape. Robert, as you look at any updates on the PADS-DOR Act and what might be going on there?

We don't have anything specific on the PADS-DOR Act. Although I'm in touch with our lobby group probably a half dozen times a day, and things in Washington are frenetically busy. Notably of recent vintage is drug pricing reductions, which in a strange way I think help our little company as compared with big pharma. Nothing specific on the PADS-DOR Act or I think we talked before about PADS-DOR Life. But it's still out there. There's also traditional barter grants that may become available. For the second program, we recently put in an application to ARCA-H. There's a European FDA-type group that's taking some interest. We've got a lot of new water for anyone who's a fisherman, like in the Cape Cod area. We've got lines in the water and we're just waiting to get a bite.

That's understood. Last question, Marta Vicaria has some comments about the ultra rare PADS for approvals based on plausible mechanisms rather than actual clinical trials. That wasn't applied to you guys though, right?

You know, you're so funny. I mean, Joanne had a good question before. That's a great question. It's right on point with something that's being discussed internally right now based on Marty McHarris' comments. It may be a side of us. It would be a first for an antibiotic to follow that pathway, but our extra identity is taking a look.

That doesn't hurt to look. Absolutely. Thank you guys very much for taking the questions. Thanks so much, Jim. Thank 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.