Acurx Pharmaceuticals Q2 2025 Earnings Call Transcript

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August 12, 2025

Key Takeaways

  • Positive Sentiment: In April the Indian Patent Office granted a new patent for our DNA polymerase 3C inhibitors extending protection through December 2039, strengthening our preclinical antibiotic pipeline.
  • Positive Sentiment: The company closed an equity line of credit for up to $12 million with Lincoln Park Capital and raised approximately $2.5 million net from warrant exercises in Q2, bolstering our cash runway.
  • Positive Sentiment: Phase 2 data for ibezaprolstat in C. difficile infection was published in Lancet Microbe, showing high rates of clinical cure with no recurrence and preservation of healthy gut microbiota.
  • Positive Sentiment: Research and development expenses decreased by $1.3 million in Q2 while general and administrative expenses fell by $600 000, reducing cash burn to roughly $400 000 per month and ending the quarter with $6.1 million of cash.
  • Negative Sentiment: A 1-for-20 reverse stock split was implemented to comply with Nasdaq listing requirements, reflecting challenges in maintaining the minimum share price threshold.
AI Generated. May Contain Errors.
Earnings Conference Call
Acurx Pharmaceuticals Q2 2025
00:00 / 00:00

There are 3 speakers on the call.

Operator

Greetings, and welcome to the Accurate Pharmaceuticals to discuss Second Quarter twenty twenty five Financial Results Conference Call. 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. It is now my pleasure to introduce Robert Shawwal, Chief Financial Officer.

Operator

Please go ahead.

Speaker 1

Thank you, Stacy. Good morning, and welcome to our call. This morning, we issued a press release providing financial results and company highlights for the 2025, which is available on our website at akorexpharma.com. Joining me today is Dave Lucci, President and CEO of AkerEx, who will give a corporate update and outlook. Following that, I'll provide some highlights of the financials from the second quarter ended June 30 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 all 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, 08/11/2025. You are cautioned not to place undue reliance on these forward looking statements, and AkerEx 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, 08/12/2025. I'll now turn the call over to Dave.

Speaker 1

Dave? Thanks, Rob. Good morning, everyone, and thank you so much for joining us to review our financial results for the '5 and also to hear some recent updates. Let me be pleased to take any questions. First, I'd like to briefly summarize just a few of our key activities for the second quarter or in some cases shortly thereafter.

Speaker 1

In April, we announced that the Indian Patent Office granted a new patent for our DNA polymerase 3C inhibitors, which expires in December 2039 subject to extension. This constitutes another significant building block for our ongoing preclinical antibiotic development program of ATX three seventy five c, which targets the treatment of infections caused by MRSA, VRE, DRST, and anthrax. In May, we closed an equity line of credit with Lincoln Park Capital for up to $12,000,000 of additional funding. In June, the company entered into a warrant inducement agreement with an existing warrant holder for the exercise of warrants to purchase an aggregate of 222,272 shares of of the company's common stock, having a current exercise price for the series a warrants to purchase 51,538 shares of the company's common stock at $65 per per share. For Series B warrants to purchase 27,400 shares of our common stock at $65 per share.

Speaker 1

And for Series B warrants to purchase 66,657 shares of our common stock at $65.20 per share. And surety warrants to purchase 56,667 shares of our common stock at an exercise price of $65.20 per share, Originally issued in July 22 and May 23 at reduced exercise price of $12 per share. In consideration for the company's agreement to issue new series g one warrants to purchase up to an aggregate of 311,180 shares of common stock with a five year term and new series g warrants to purchase up to an aggregate $133,003.53 shares of our common stock with a five five year term from shareholder approval each had an exercise price of $8.50 per share. The gross proceeds to the company from the exercise of the existing warrants was approximately $2,700,000 with net proceeds of $2,500,000 after deducting fees and expenses payable by the company. We want a decent transaction closed on June 20.

Speaker 1

The company will continue its multistep approach to raising capital through customary financings, warrant inducements and public private partnership opportunities going forward. In June, we announced the publication of our phase two d clinical trial data for ibezaprolstat in c difficile section in Lancet Microbe, the world leading microbiology research journal. This publication is available on our website at accuratepharma.com. The Lancet Microbe summary highlighted azacoprostat's k two results as follows, and I quote, results included high rates of clinical cure and azacoprostat treated subjects with no recurrence. Furthermore, ipasifolcet 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 CDI, end quote.

Speaker 1

The Lancet publication also highlighted that vezapulstat potential is a novel antibiotic treatment for CDI with high rates of clinical cure and sustained clinical cure while preserving and restoring the healthy gut microbiota. The senior author, professor Kevin Gary, PhD, University of Houston, and the coauthor of the IVF Infectious Disease Society of America treatment guidelines for c difficile infection noted that current US and European treatment guidelines for CEI recommend only two antibiotics for treatment, oral vancomycin or fidaxomicin. Vancomycin is most commonly used but has a low clinical cure rate of seventy to ninety two percent and a sustained clinical cure rate of forty two to seventy one percent. Tadaxamycin has fewer recurrences, but low rates of clinical cure at about eighty four percent and sustained clinical cure at sixty seven percent. Professor Gary further noted that both marketed antibiotics for CDI are associated with emerging antimicrobial resistance, stating, and I quote, the clinical need for a new antibiotic like ibezafulstat to treat CDI is underscored by a recently published study in clinical infectious diseases by doctor Curtis Pronke of the Cleveland VA and conducted in a hospital setting, documenting that c zeolipse with clinically relevant reduced fidaxomicin susceptibility may emerge during therapy and spread to other patients.

Speaker 1

The medical community should be aware of this alarming finding, end quote. Again, that's by doctor Gary. Also in June, we announced results from our collaboration with Leiden University Medical Center of its study of the mechanism of action of our polymerase 3C platform of inhibitors with data presented at the Federation of American Society for Experimental Biology Scientific Conference, the lead in the in The Netherlands on May 21. A scientific presentation was provided by Mia Herron, PhD from Leiden University Medical Center entitled a unique inhibitor confirmation selectively targets the DNA polymerase policy of gram positive priority pathogens. This scientific conference is the premier venue for the newest research and technological trends in molecular machines in the human body that ensure DNA replication and expression of genes to create proteins that make up the cell.

Speaker 1

In August, we implemented a one for 20 reverse stock split in an effort to comply with the NASDAQ listed maintenance requirements. We continue to identify and pursue funding opportunities for our phase three clinical trial program for abetzapolumab and consider alternative financial pathways to achieve success. We have several initiatives underway to defend, and we'll report in future updates as appropriate. As we continually reported, clinical results continue to demonstrate its leadership in the field and experience in potentially life threatening infectious disease called c difficile bacteria that the US CDC categorizes as an urgent threat and calls for new classes of antibiotics for initial treatment, but also have low incidence of recurrence. Edezapolstat has FDA QIDP and fast track designations for the treatment of CDI.

Speaker 1

We also believe that Edezapolstat, if approved, could make a favorable economic impact by reducing the overall annual US cost burden for CZF infection of approximately $5,000,000,000 a year, of which 2,800,000,000.0 is due to recurrent infection, what we call the secondary market. With our continuing momentum and passion to achieve success for our stakeholders, we remain confident that while development of ipilimposite's competitive profile continues to strengthen, the best is yet to come as we navigate through these very challenging times in the macroeconomic environment and in our industry sector. And now back to our CFO, Rob Shallow, to guide you through the highlights of our financial results for the '25. Rob? Thanks, Dave.

Speaker 1

Our financial results for the second quarter ended 06/30/2025 were included in our press release issued earlier this morning. The company ended the quarter with cash totaling $6,100,000 compared to $3,700,000 as of 12/31/2024. During the second quarter, the company raised a total of approximately $3,400,000 of gross proceeds through purchases under the equity line of credit and a warrant inducing agreement. Research and development expenses for the three months ended June 30 were $500,000 compared to $1,800,000 for the three months ended 06/30/2024, a decrease of $1,300,000. The decrease was due primarily to to a decrease in manufacturing costs of $300,000 and a decrease in consulting costs of $1,000,000 as a result of the prior year trial related expenses.

Speaker 1

For the six months ended 06/30/2025, research and development expenses were $1,100,000 versus $3,400,000 for the six months ended 06/30/2024. The decrease of $2,300,000 was primarily due to a reduction of $600,000 in manufacturing costs and a $1,700,000 decrease in consulting costs due to higher trial related costs in the prior year. General and administrative expenses for the three months ended 06/30/2025 were $1,700,000 compared to 2,300,000 for the three months ended 06/30/2024, a decrease of $600,000. The decrease was primarily due to a $700,000 decrease in share based offset by a $100,000 increase in professional fees. For the six months ended 06/30/2025, general and administrative expenses were $3,300,000 versus $5,100,000 for the six months ended 06/30/2024, a decrease of $1,800,000.

Speaker 1

The decrease was due primarily to a $600,000 decrease in professional fees and a $1,200,000 decrease in share based compensation. The company recorded a net loss of $2,200,000 or $1.89 per diluted share for the three months ended 06/30/2025 compared to a net loss of $4,100,000 or $5.21 per diluted share for the three months ended 06/30/2024, and a net loss of $4,400,000 or $4.01 per diluted share for the six months ended 06/30/2025 compared to a net loss of $8,500,000 or $10.84 per diluted share for the six months ended 06/30/2024, all for the reasons previously mentioned. The company had a reverse split adjusted 1,470,352 shares outstanding as of 06/30/2025. With that, I'll turn the call back over to Dave. Thanks, Rod.

Speaker 1

It's all of you for joining us today. And now back to our operator, Stacy, to open the call to for questions. Stacy?

Operator

Thank thank you. We will now be conducting a question and answer session. If you would 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 to remove yourself from the queue.

Operator

For participant queue, speaker equipment, it may be necessary to pick up your handset before pressing the star key. First question, Jim Malloy with Alliance Global Partners. Please go ahead.

Speaker 2

Guys. Good morning. Thank you for taking my questions. Good morning, Jim. Quick call.

Speaker 2

Thank you. Looking at the OpEx coming down in line, certainly with cash preservation and a high priority. Is this a trend we should expect to continue through rough '25 and '26? And then maybe following up on that, I know it's bit up in the air and a little out of your hands. But as an outside of looking in, when should we anticipate potentially either partnership for is there a partnership to be signed?

Speaker 2

Is there something at '25? Or you got put it in 2025, 2026? And then and you're getting these trials up and running for Beza. Thank you. Sure, Jim.

Speaker 2

I'll start with

Speaker 1

your second question. I'll ask you to repeat the first. But for your second question, you know, it it could be any time here in the second half in terms of a private partnership if we're able to announce something like that. In terms of I use the word partnership broadly to include government agencies because that that's their preference. They they like to to say that they're not providing grants.

Speaker 1

They're entering into partnerships, and they expect their incubator companies to be good partners. So the that process is ongoing and will certainly slip into 2026 given the dynamics that are going on in Washington. So the the federal government year end is September 30. And as I understand it through the folks we work with in Washington, they're expecting a continuing resolution toward the end of the year, kind of the usual annual punt to kinda calendar year end as being likely the time when funding for the new fiscal year gets appropriated, you know, through the starting with the House Ways and Means Committee. So those those are all going very well, I would say, and we're confident that we will have success in these regards.

Speaker 1

You know? But I think, particularly with the government, it's gonna take time. But could I ask you to ask the first question again, please?

Speaker 2

Yes. Of course. So and I see that you guys are, you know, preserving cash. Operating expenses coming down nicely in line with your expectations of your capital. Is that something we should expect?

Speaker 2

That trend we should continue through second half twenty five and into '26?

Speaker 1

Oh, absolutely. Yeah. We're we're training tremendously. What I would say is, you know, when you're seeing things like g and a expenses that we report on these earnings calls, you know, that that's a different number than cash flow. They that includes cash and noncash items.

Speaker 1

So our cash burn is, you know, it's, you know, down to close to 400,000 a month at this point, and we expect to continue that process. Now there's there's some clinical strategy things that we will be announcing in the near future that we're we're currently considering for a new very small clinical trial that we can handle financially without without a lot of heavy lift on our end. But we'll be able to come out with more information on that next quarter after after we get in front of our board of directors.

Speaker 2

Excellent. And as always, excellent work on keeping accruals in line. Thank you,

Operator

David. Thank

Speaker 2

you so much.

Speaker 1

Thank you, David.

Operator

Next question comes from Matthew Keller with HP one hundred. Please proceed.

Speaker 2

Yeah. Hey. Good morning, everyone, and congrats on the quarter. So just two quick ones from us. Obviously, the publication of the two two d data was very nice.

Speaker 2

I was wondering if there were any additional feedback that you got from either physician community or KOL community on that publication? And then the second question I have for you is kind of related to maybe the previous question, but are there any other rate limiting steps ahead of the upcoming Phase III studies that we should be thinking about?

Speaker 1

Well, thank you, Matthew, for the questions. For rate limiting steps, the only one, and it's not even really a long, you know, rate limit, would be to, you know, as we talked about the the fill finish of the ibezaprolstat supply into the phase three trials. We we've been reluctant to do fill finish because once you do, then your drug is dated. And we wanna postpone that to maximize the amount of time we have to use the ibezapulstat without it becoming obsolete. So that may be a couple of month process.

Speaker 1

It it's nothing significant. But everything else is literally ready. The European Medicines Agency and FDA amazingly agreed entirely on the identical chain protocol for the two trials. So so that's that's not quite well.

Speaker 2

Yeah. Okay. Great. Makes sense.

Speaker 1

Thank you.

Operator

There are no further questions. This does conclude today's teleconference. Thank you for your participation. You may now disconnect your

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