Q3 2025 Acurx Pharmaceuticals Inc Earnings Call

Here we go again, Rob.

Yep.

Greetings, and welcome to the aerex pharmaceutical. Third quarter 2025 conference call and business updates. At this time, all participants are in a listen-only mode. A brief 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. It is now

Now my pleasure to introduce your host, Robert shawa Chief Financial Officer, thank you, sir. You may begin.

Thank you. Maria. Good morning and Welcome to our call.

This morning, we issued a press release, providing financial results and company highlights for the third quarter of 2025.

Which is available on our website at aerex.pharma.com.

Following that, I'll provide some highlights to the financials from the third quarter, end of September 30, 2025.

And then turn the call back over to Dave for his closing remarks.

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.

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 today. Wednesday, November 12th, 2025.

You are cautioned not to place undue Reliance on these forward-looking statements and accuracy exclaims. 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, November 12th, 2025.

in addition, we met the minimum stockholder Equity threshold of 2.5 million under the NASDAQ listing rules

In September the Australian patent office, granted a new patent for the company's class of DNA polymerase 3C Inhibitors, including composition of matter.

To date after X as obtained. 3 us packs. 1 Israeli. Pass 1 Japanese pad, 1 Indian pad and now the Australian patent.

In each case, which cover the ACX 375c program related to DNA file, 3C inhibitors for infections caused by Grand positive bacteria, including MRSA VRE and prsp with other country level filings and process.

In late September, we filed the amendment with the Secretary of State of the State of Delaware with immediate effect.

In October, the company received gross proceeds from the exercise of 170,000 Series F warrants.

For approximately 1.4 million.

Also when I October, we are 1 of 5 companies selected to make a formal presentation at ID weeds and Atlanta.

At the session, entitled new antimicrobials in the pipeline.

The company's presentation included an update on our desert pulse that and it's microbiome sparing properties.

showing a potential microbiome-sparing class effect of representative compounds from our DNA P3C inhibitor preclinical pipeline.

In describing the work performed at his laboratory at the University of Houston. Dr. Gary stated initial work on novel lead. DNA file, 3C inhibitor compounds indicate that the positive microbiome sparing results from our physical stat studies. May be a class affect. This is an important finding because microbiomes sparing likely contributed to izopo Stats sustained. Efficacy in the phase 2 trial for C diff infection where no patient cured of ciff experience. The recurrence

In our recent experiments, mice given the comparator antibiotic demonstrated an overabundance of uncommon and harmful gram-negative bacteria known to contribute to the recurrence of infection.

Dr. Gary further stated these data indicate a low probability for DNA file, 3C Inhibitors to increase the risk of causing a C, diff infection micro meyin resistant and and Tara caucus or other gut microbiome related infections.

Next this month on November 10th, the company announced that the nature Communications scientific journal published results from our scientific collaboration with lighten University Medical Center in the Netherlands. Demonstrating structural biology research that reveals for the first time a DNA file 3C inhibitor as a post that bound to its Target,

The publication is entitled, a unique inhibitor, confirmation selectively targets, the DNA pile 3C of grand, positive, priority, pathogens.

This is an important milestone in our highly productive scientific collaboration with Leiden University, Medical Center in advancing development of these new to Nature compounds. Fortifying the foundation for the rational development of our Innovative class of antimicrobials against other Grand positive priority pathogens.

We continue to identify and pursue funding opportunities for our phase 3. Clinical trial program for advisor, post that as well as consideration of alternative Pathways to achieve success.

We have several initiatives underway to this end, and we'll report in future updates as appropriate.

As we've continually reported, our Bezos clinical and non-clinical results to continue to outperform in a serious and potentially life-threatening, infectious disease caused by sea bacteria, that the CDC categorizes as an urgent threat and calls for a new classes of antibiotics for initial treatment that also have a low incidence of recurrence.

I also like to highlight that our company does recognize the month of November as sea death, awareness month as designated by the CDC and supports the work of the Peggy. Willis foundation, in raising awareness, educating and advocating for the prevention treatments clinical, trials, and environmental safety of C diff infections worldwide.

for more information about the work of the Peggy Willis Foundation, please visit their website at cdiff

Additionally, as a course that has FDA QIDP and Fast Track designation for the treatment of CDI.

As well as SMEs, small and medium enterprises in the EU.

Economic impact by reducing. The overall annual us cost burden for C diff infection of approximately 5 billion dollars on which 2.8 million is due to recurrent infection.

We remain confident that while development of Life, as a pro stats, competitive profile continues to strengthen. We will continue to navigate successfully through these challenging times in the macroeconomic environment and in our industry sector.

And now back to our CFO, Rob Sher got you through the highlights of our financial results for the third quarter of 2025 Rob.

Thanks Dave.

Our financial results for the third quarter ended, September 30th 2025, we're included in our press release issued earlier this morning.

The company ended the quarter with cash totaling $5.9 million.

Compared to 3.7 million as of December 31, 2024.

During the quarter, the company raised a total of approximately 1.7 million dollars of gross proceeds.

Through purchases under the equity line of credit.

in addition, after quarter end, the company raised, an additional 1.4 million from a warrant exercise by 1 institution and investor

Research and development. Expenses through a 3-month end of September 3020 2025.

Or 04 million.

Compared to 1.2 million for a 3 months, ended September 30 2024.

A decrease of 0.8 million.

The decrease was due primarily to a decrease in manufacturing costs, the $0.1 million.

and a decrease in Consulting costs 0.7 million as a result of the prior year trial related expenses.

for the 9 months, ended September 30th 2025,

Research and development expenses are $1.6 million compared to $4.6 million for the nine months ended September 30.

2024.

The decrease of $3 million was primarily due to a reduction of $0.7 million in manufacturing costs.

And the 2.3 million decrease in Consulting costs due to higher trial related costs.

In the prior year.

General administrative. Expenses for the 3 months. Ended September 30th 2025.

Compared to 1.6 million for a 3 months. Ended September 3222 2024.

The expenses remained relatively consistent from the prior year.

As a 0.2 million. Decrease in compensation related costs, were offset by a 0.1 million increase in legal fees.

General and administrative expenses were 4.9 million versus 6.8 million for the 9 months. Ended September 30th 2024

The decrease was primarily due to a 0.6 million decrease in professional fees.

And a 1.3 million decrease in, share based compensation.

The company reported a net loss of $2 million.

Or a $1.23.

Per diluted share for the 3 months, ended September 3020 2025.

That was compared to a net loss of $2.8 million, or $0.0345 per diluted share, for the three months ended September 30, 2024.

and then that loss of 6.4 million or 5 dollars and 1 cent per diluted share for the 9 months, ended September, 30 2025

With that, I'll turn the call back over to Dave.

Thank you, Rob, and to all of you for joining us today. Now, back to the operator to open the call for questions. Maria?

Thank you. We will now be conducting a question and answer session. If you would like to ask a question, please press star 1 on your telephone keypad. A confirmation tone will indicate that your line is in the question queue. You may press star 2. If you would like to remove your question from the queue,

For participants using speaker equipment, it may be necessary to pick up your handset before pressing the star Keys 1 moment, please while we pull for questions.

Jason McCarthy with the maxim group, please, proceed with your question.

Hi, this is Joe.

Good morning. This is... Oh, sorry.

Uh, this is Joanie on the call for Jason McCarthy. Thank you for taking your questions.

Um, so starting with us, so given recent changes uh, under the current FDA Administration. Um, do you see increased potential for the agency to prioritize? A domestically manufactured, uh, novel antibiotics? And if you could share your, uh, prospective on the pastor act, if there's any, uh, still meaningful potential for it to advance or impact the uh antibiotic uh funding landscape. Thank you.

Uh, thank you Joanne. Um,

So uh with regard to the FDA, we certainly see buzz on the trees. Um,

And, and maybe this, uh, relates more to a sister agency that we're talking about a, a, with about a public private partnership, but we're already FDA FasTrak and qidp. Um, there there is some legislation that may be coming out of related to, um, novel, uh, drugs that treat life-threatening conditions that we may be able to Avail ourselves, uh, to

We're not sure yet. Uh we would be the first antibiotic under that program, but we're certainly on it and looking into it.

Um, the second, uh, component of your question? The pastor act, I don't think anyone in Washington is focused on the pastor Acts or project bio Shields. Um, given what's going on in Washington? I think, 90% of the folks down there are wondering what their new appropriation is going to be for a fiscal 26.

Um, because of the shutdown and that kind of thing, it's going to be until the end of the year until folks are sure what they're going to have to spend.

Um, so I would expect both of those will continue to be under consideration when normaly returns to the Capitol.

Uh, but that may take some time.

Got it. That was helpful. Um, just giving recent shifts under their current FDA leadership, do you see increased potential for the agency? Um, I'm sorry. Uh, if the proposed clinical priority review voucher framework impacts the company's regulatory approach or commercial strategy going forward.

Um, no. It it would be the same strategy. We would certainly try to Avail ourselves, uh, of that, uh, program at the appropriate time. We're aware of it. Um, but you know, we have a couple of phase, 3 trials, uh, in front of us along with the 20th, uh, take all comers trial in the, uh, this secondary C diff Market that we'd like to get underway kind of ASAP.

Got it. Um, and just the last 1 for me, um, has a team, uh, explored, uh, the possibility of filing for approval, based solely on the a phase to be. I be the data and I guess what would the regulatory pathway look like, if you were to take that route,

Database.

Um, so we're going to need, you know, whatever we're able to kind of follow as the...

Most recent regulatory pathway. If if a new 1 you know, the conditional approval pathway. For example, we're still going to need phase 3 trial data to support the safety database.

Got it. We don't we don't have enough, uh, patients yet for the FDA to be comfortable.

Got it. Uh oh, thank you so much. Appreciate you taking time to answer your questions. Thank you, Joan.

Our next question comes from, Matt Keller with HC Wayne Wright please. Proceed with your question.

Hello. Good morning and thanks for taking a questions. Uh, just 1 from us, uh, you kind of touched on this, but you've had a um, a number of recent Publications and presentations. Um, I'm kind of curious how these data might be informing or potentially changing your clinical strategy going forward. Particularly head of the start of the the potential phase 3.

Um, it's not, uh, I mean, the, the data is compelling, I mean to have a microbiome sparing class effect. Um, that, that means that

And Anthrax and VRE, you know, will be very confident that they're going to be very, very few or no reinfections because of the class effect of the microbiome sparing, uh, mechanism of action. Um, so it doesn't really change the clinical program, but what it does do is it makes us confident that we'll be able to demonstrate to the scientific community that we deserve a seat at the table in a way, we'll do that. Um, is to do in the in the secondary or Salvage market for C diff in the worst of the worst cases will dose up to 20 patients, who have been, um, who have had 3 prior episodes, or more of C diff

Treated by the standards of care, we expect to be able to show that we're able to cure those patients of their seed death with lasting cures because of the elucidation we have now in our mechanism of action.

So we'll basically be saying to the scientific Community world of life.

You know, the existing antibiotics their standards of care are fine. Um, but we deserve a seat at the table.

so we think that data will be, you know, compelling and

We would anticipate that, uh, we'll that data will help us to engender a public, private partnership.

Thanks man.

Our next question comes from James Malloy, with Alliance Global Partners, please proceed with your question.

Hey, guys. Good morning. Thank you very much for taking my questions. Uh, I wonder if there's any way to put a, uh, some a framework or a timing around potential, uh, partnership discussions. I know this is, It's always a part of Partnerships over there till it's there. Um, but you highlighted alternative additional part, uh, Pathways in your prepared remarks, uh, for get in the phase 3. Is there any way to put, uh, some error bars around when that could potentially happen? Uh, and then I have a couple follow-ups. Thank you.

No problem. Thank you.

Um,

So you know there it is. Uh a partnership is a 2-way street so you know we can't tell exactly when the people we're talking to uh are going to come to terms or you know, if they're going to come to terms. But I would be surprised if on the next earnings call. Uh there hasn't been some, some major news for the company.

Excellent, then, uh, thanks for that then. Um, any on the on the Q8 p and Fast Track designation? There there's no, uh, sort of expectation or time limit or or sort of movement that has to go forward for those to, to keep going. Those are once you get them, you sort of have them in proper perpetuity

Absolutely, absolutely got. Uh, thank you and then, uh, just the last question, too. On the Opex, pretty steady state in there. You guys are, uh, in some respects, uh, holding fast, are these numbers. The numbers we should inspect going forward again. Borrowing, uh, something substantial. Being an announcement for the next call.

Uh, yes. We continue to tighten our belt.

And uh, we would think that, if anything, our cost will continue to gradually go down, we've done a lot of cost cutting, I'm sure we can find more, uh, Corners to cut, um, but it's kind of we're in a kind of a good position with, you know, I think we said 5.9, plus we had the 1.4 after the end of the quarter. So you know with 7 million ish dollars in the tank and another 9 million remaining on our ELO, you know, we can, you know, kind of bite our time while we wait for a public private partnership or uh some sort of m&a activity.

Absolutely comments to to Rob for keeping the hand Steady Hand of the tiller. Thank you guys for taking the questions.

Thank you so much.

We have reached the end of our question and answer session, which now concludes today's teleconference. You may disconnect your lines at this time. Thank you for your participation.

Thanks Maria.

Thank you, Maria.