Q1 2025 Acurx Pharmaceuticals Inc Earnings Call
Speaker Change: Greetings and welcome to the Acura 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.
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.
Speaker Change: I would now like to turn the call over to your host Rob shower, Chief Financial Officer of accurate Pharmaceuticals. Thank you you may begin.
Rob Shower: Thank you Melissa good morning, and welcome to our call.
Rob Shower: This morning, we issued a press release, providing financial results and company highlights for the first quarter 2025, which.
Rob Shower: Which is available on our website at <unk> Dot com.
Speaker Change: Joining me today is David Lu Qi, President and CEO of Act Rex, who will give a corporate update and outlook.
Speaker Change: 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 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 that are subject to change.
Speaker Change: A number of risks and uncertainties that may cause actual results to differ materially from those contained in the forward looking statements <unk>.
Speaker Change: Investors should consider these risks and other information described in our filings with the Securities and Exchange Commission.
Speaker Change: Including our quarterly report on Form 10-Q, which we filed yesterday Monday May 12 2025.
Speaker Change: You are cautioned not to place undue reliance on these forward looking statements and <unk> disclaims any obligation to update such statements at any time in the future.
Speaker Change: This conference call contains time sensitive information that is accurate only as of the date of this live broadcast Tuesday may 13th 2025.
Dave Lucci: I'll now turn the call over to Dave Lucci gays.
Speaker Change: Thanks, Rob and good morning, everyone and thank you so much for joining us to review our financial results for the first quarter of 2025.
Dave Lucci: There are some recent updates.
Dave Lucci: And then we'd be pleased to take any questions.
Dave Lucci: Firstly I'd like to briefly summarize a few of our key activities for the first quarter 2025 or in some cases shortly thereafter.
Dave Lucci: In January we announced that we closed at two and a half million dollars registered direct offering priced at the market under NASDAQ rules.
Dave Lucci: Also in January we announced that we received positive regulatory guidance from the European Medicines Agency.
Dave Lucci: Close to that phase III clinical trial program, which is aligned with FDA on Madison manufacturing non clinical and clinical aspects of the phase III program.
Dave Lucci: <unk> guidance also confirm that as opposed to ask regulatory pathway for a marketing authorization application to be filed by the company after successfully completing phase III clinical trials.
Dave Lucci: The mutually consistent feedback from both E N. A FDA atherectomy is well positioned to commence our international phase III registration program.
Dave Lucci: In February and March we announced a new publications in the journal of antimicrobial agents and chemotherapy units.
Dave Lucci: Still very small or non clinical studies, which we believe we can leverage and we can leverage digital further positive differentiation.
Dave Lucci: The competitive advantage of that as opposed to that versus all other antibiotics used for first line therapy to treat C difficile infection or a C E O.
Dave Lucci: And for that matter given our clinical results today, we anticipate that this anti recurrence effect like basketball.
Dave Lucci: Could mitigate the patient's need for expensive microbiome therapeutic agents superb to prevent recurrence.
Dave Lucci: Specifically in February we announced positive results from the first study conducted by Dr suggested Macpherson from the University of Houston.
Speaker Change: On it by the National Institute of allergy and infectious disease.
Dave Lucci: It wasn't even some of them are studying that predicted.
Dave Lucci: I almost snorted potential as it pulls that for treating C. Diff.
Scientific advisors consider this to be a major finding which provides a mechanistic explanation right as opposed to that sound like Sydney and that's the predicted bacteria bactericidal interaction between all of that and its target.
Dave Lucci: The power <unk>.
Dave Lucci: Allows regrown that microbes no different for <unk>.
Dave Lucci: <unk>.
Speaker Change: The second study conducted by Dr. Tracking wells from the University of Montana was funded by the National Institute of allergy and infectious disease.
Speaker Change: The answer is no.
Dave Lucci: <unk> Center for.
Dave Lucci: Advancing translational science and address.
Dave Lucci: This study is the first head to head comparison.
Speaker Change: Michael I don't changes associated with <unk>.
Speaker Change: Oh is that right.
Speaker Change: That's the other anti CD at CDI antibiotics, and a general frame hostile.
Speaker Change: The data show that changes in Alpha and beta microbiome diversity is following that as opposed to a treatment were less pronounced compared to those observed in banco milestone or metronidazole treated groups complementing prior phase II clinical findings showing I suppose that's more selective.
Speaker Change: Sorry bacterial activity.
Speaker Change: Further on very important and very importantly, notable differences were observed between the microbiome.
Speaker Change: As opposed to that and say that somebody said.
Speaker Change: Groups, which may allow for differentiation at least two anti biotics in future studies.
Speaker Change: These results established that vesicle, a SaaS differentiating effects on the gut microbiome, indicating a more selective spectrum of microbiome alteration compared to a broad spectrum antibiotics like vancomycin and metronidazole.
Narrower spectrum.
Speaker Change: Microbiome alteration comparison maximize.
Speaker Change: Also in February the Japanese patent office rapidly.
Speaker Change: For our DNA polymerase inhibitors, which expires in 2030 time subject to extension.
Patrick: Yes, Patrick due to significant building blocks.
Speaker Change: Ongoing development of <unk> 375.
Speaker Change: Preclinical anti biotic program targeting the treatment of infections caused by <unk> resistant staph vancomycin resistant enterococcus and anthrax.
Speaker Change: In March we announced the closing of a registered direct offering and concurrent private placement raising gross proceeds of $1 1 million.
Speaker Change: And just last month, the Indian patent office granted a new pad or DNA polymerase inhibitors, which expires in December 2039 subject to extension.
Speaker Change: This is another significant building block of our ongoing preclinical antibiotic development program.
Speaker Change: 375.
Speaker Change: Which targets the treatment at MRSA vre anthrax infections.
Speaker Change: And just last week on May eight we closed an equity line of credit with Lincoln Park capital.
Speaker Change: At $12 million of additional funding.
Speaker Change: Okay.
Speaker Change: Looking forward to the weeks ahead I can share with you that our outstanding phase two clinical trial data.
Speaker Change: Has been accepted for publication in the Premier Medical Journal Lancet micro.
Speaker Change: And as now impress to be published shortly.
Speaker Change: It summarizes that as opposed to at phase II results.
Speaker Change: Trials.
Speaker Change: And I quote.
Speaker Change: Results included high rates of clinical cure.
Speaker Change: As opposed to treating subjects with no recurrence.
Speaker Change: Furthermore, it as opposed to have was found to be safe well tolerated and associated with the preservation of key health promoting bacteria responsible for bile acid homeostasis a fee.
Speaker Change: Colin and preventing recurrent CDI.
Speaker Change: The publication establishes us as opposed to ask agile as a novel antibiotic treatment for cei with high rates of clinical cure and sustained clinical cure well minimally disturbed in the protective gut microbiota.
Speaker Change: The senior author.
Speaker Change: Patrick Keddy, Gary University of Houston, and co author of the ICSC.
Speaker Change: Guidelines for CDI noted that current U S and European treatment guidelines for CDI.
Speaker Change: And then only two antibiotics.
Speaker Change: <unk> or financial advice.
Speaker Change: <unk> is most commonly used but it has a low clinical cure rate of.
Speaker Change: 70% to 92%.
Speaker Change: And a sustained cure radios, just 42, 71%.
Speaker Change: But suffice it has fewer recurrences, but low rates of clinical cure, 84% and sustained clinical cure 67%.
Speaker Change: After Gary further analysis of both the antibiotics are associated with emerging antibody anti microbial resistance.
Speaker Change: What are the clinical need for a new antibiotic like that as opposed to treat CDI is underscored by a recently published study in clinical infectious disease high vacuum furnace staci.
Speaker Change: It's up in a hospital setting.
Speaker Change: Okay.
Speaker Change: C difficile islands' with clinically relevant reduce maximizing.
Speaker Change: Susceptibility may emerge during therapy and spread to other patients and.
Speaker Change: And therefore, you should be aware of as alarming.
Hello.
Speaker Change: Also upcoming.
Speaker Change: Regarding <unk> as overall G&A, Paul <unk> inhibitor platform is a scientific presentations to begin on May 21.
Speaker Change: Hi, good afternoon.
Speaker Change: From Leiden University Medical center in the Netherlands.
Speaker Change: Titles and unique inhibitor <unk>.
Speaker Change: Confirmation selectively targets the DNA policy policy of Grand positive priority patches.
Speaker Change: Yeah, sorry to the conferences sponsored by the Federation of American societies for experimental biology.
Speaker Change: There's a premier venue for their newest research and.
Speaker Change: And technological trends in molecular machines inside the human body that ensure DNA replication.
Speaker Change: Ration of genes to create proteins that make up itself.
Speaker Change: We continue to identify and pursue funding opportunities for our phase III.
Speaker Change: Pulse that clinical trial program.
Speaker Change: Several initiatives underway to do that and we hope to have something to report in future updates.
Speaker Change: As we have continually reported as an asset class that clinical results continue to outperform in a serious and potentially life threatening infectious disease caused by C difficile bacteria.
Speaker Change: The CDC categorizes as an urgent threat and calls for new classes of antibiotics for initial treatment, but also have a low incidence of recurrence.
Was that a bit.
I suppose that has FDA <unk> and fast track designations for the treatment of CDI.
Speaker Change: We also believe that as oppose that yet approved but it makes it favorable economic impact by reducing the overall annual U S cost burden for C diff infection.
Speaker Change: Which is $5 billion per year.
Speaker Change: It's $2 8 billion is due to recurrent infection.
Speaker Change: 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 and the macroeconomic environment and in our industry sector.
Speaker Change: And now back to our CFO Rod Shallots Guide you through the highlights of our financial results for the first quarter of 2025.
Speaker Change: Rob.
Yeah.
Speaker Change: Thanks, Dave.
Rob Shower: Our financial results for the first quarter ended March 31, 2025 are included in our press release issued earlier this morning.
Speaker Change: The company ended the quarter with cash totaling $4 6 million compared.
Speaker Change: Compared to $3 $7 million as of December 31, 2024.
Speaker Change: The company raised a total of approximately $3 $6 million of gross proceeds through two registered direct offerings during the quarter.
Speaker Change: Research and development expenses for three months ended March 31 were $6 million compared to $1 $6 million for three months ended March 31 2020 for.
Speaker Change: A decrease of $1 million.
Speaker Change: The decrease was primarily due to a decrease in manufacturing costs of <unk> $4 million.
Speaker Change: And a decrease in consulting costs of $6 million as a result of the prior year trial related expenses.
Speaker Change: General and administrative expenses for the three months ended March 31 2025.
Speaker Change: We're $1.6 million.
Speaker Change: <unk> to $2 $8 million for three months ended March 31 2024.
Speaker Change: A decrease of $1 $2 million.
Speaker Change: The decrease was primarily due to $7 million decrease in professional fees, resulting from lower consulting expenses.
Speaker Change: And a point $6 million decrease in share based compensation costs.
Speaker Change: The company reported a net loss of two.
Speaker Change: $2 $1 million or 11 cents per diluted share for the three months ended March 31 2025.
Speaker Change: Compared to a net loss of $4 4 million or 28 cents per diluted share for the three months ended March 31 2024.
Speaker Change: All for the reasons previously mentioned.
Speaker Change: The company had 22.397 million 511 shares outstanding as of March 31, 2025.
Dave Lucci: With that I'll turn the call back over to Dave.
Dave Lucci: Thanks, Rob Yes to all of you for joining US today I'll now turn the call over to Melissa our operator to open the call up for questions Melissa.
Melissa: 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. Kim You May Press Star two if he 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.
Speaker Change: Our first question comes from the line of Jason Mccarthy with Maxim Group. Please proceed with your question.
Joanne Lee: Hi, Good morning. This is Joanne Lee on for Jason Mccarthy, Thanks for taking our questions.
Joanne Lee: Just one from me regarding the recent publications highlighting I bet, there's a selective activity and potential microbiome preserving your Fox I'm just curious if the company plans to explore this further.
Joanne Lee: These complementary findings are informed the phase III trial in any way are you considering incorporating microbiome related endpoints to help reinforce IV I bet, there's differentiation in the CDI space. Thanks.
Dave Lucci: Thank you very much Joanne yes, we are indeed exploring this actively.
Joanne Lee: It's already.
Dave Lucci: Microbiome.
Dave Lucci: Relation and restoration is already a secondary endpoint in the phase III program.
Dave Lucci: As it has been in place to be.
Dave Lucci: But we're exploring it nonetheless.
Dave Lucci: We're seeing that this is an area of differentiation, which is one of the primary reasons. We believe that we're seeing show distinctively less recurrent C. Diff than he is experienced by patients on other antibiotics.
Speaker Change: And with the New administration in Washington, and Marty Macquarrie.
Speaker Change: I believe we're reading the tea leaves and exploring other possibilities.
Speaker Change: In terms of pathway to approval.
Speaker Change: More on that on the next call but.
Speaker Change: That's currently a hot topic internally.
Speaker Change: Great that was helpful looking forward to see how things progress.
Speaker Change: Thank you so much.
Speaker Change: Thank you again as a reminder, its star one to join the question queue. Our next question comes from the line of James Molloy with Alliance Global Partners. Please proceed with your question.
James Molloy: Hey, good morning, guys. Thanks for taking my questions.
Speaker Change: Just a quick looking at.
Speaker Change: So the G&A and in R&D and Opex I guess for the quarter are these levels, we should expect going forward I see that R&D.
Speaker Change: Coming up pretty dramatically I know you've been waiting to get the phase III start it'll ramp up and I presume it will ramp up once that gets going.
Speaker Change: Any thoughts on the trajectory of that through.
Speaker Change: The 2025 and any updates on sort of the.
Speaker Change: As expected start date of any potential phase threes.
Jim: Thanks, So much Jim I appreciate the questions.
Speaker Change: Yes, I can happen here, we've done some dramatic cost cutting.
Jim: That started in the first quarter.
Of 2025 and will continue so I would expect.
Jim: Both our G&A and R&D costs to continue to go down.
Jim: As quarters go by until we start the phase III program.
Speaker Change: I don't want to provide a.
Speaker Change: Hypothetical date for the start of phase III, because we don't have the funding yet and since we don't make the decision on <unk>.
Speaker Change: On the other side of where that funding is coming from.
Speaker Change: It's kind of hard to project, but we do have a lot of irons in the fire.
Speaker Change: We did close on the equity line of $12 million.
Speaker Change: With Lincoln Park capital last week, so we feel that we are in decent position relative to.
Speaker Change: Other biotech companies.
Speaker Change: You kind of tread water until one of these funding opportunities comes through.
Speaker Change: And as I know you guys have been excellent.
Speaker Change: Stewards of shareholder capital.
Speaker Change: Notably the accruals are always in good shape Robert.
Speaker Change: As you look at the any updates on the past direct and what might be going on there.
Speaker Change: We don't have anything specific on the past due are at.
Speaker Change: Although you know I'm in touch with our lobby group, probably a half dozen times, a day and things in Washington.
Speaker Change: Our frenetically busy.
Speaker Change: Notably of recent vintage the drug pricing.
Speaker Change: Reductions, which.
Speaker Change: In a strange way I think help our little company as compared to big pharma.
Speaker Change: Nothing specific on the pass through or act or I think we've talked before about pass through or light.
Speaker Change: But.
Speaker Change: Its still out there theres also traditional BARDA grants that may become available.
Speaker Change: And for the second program, we recently put in an application to ARPA H.
Speaker Change: So.
Speaker Change: And Theres a European F. FDA type group that has taken some nutrient so theres a lot we've got a lot of lines in the water. So to speak for anyone who is a fisherman like in Cape Cod area like yourself, we got lines in the water and we're just we're just waiting to get it right.
Speaker Change: That's understood and last question.
Speaker Change: Martin Currie had some comments about sort of the ultra rare path for approvals based on plausible mechanism rather than.
Speaker Change: And then actually in clinical trials.
Speaker Change: That wouldn't apply to you guys all right.
Speaker Change: So funny I mean, Julien had a good question before.
Speaker Change: Well, that's a great question, it's right on point with.
Speaker Change: Something that's dangerous.
Speaker Change: <unk> discussed internally right now based on Marty Mckenna.
Speaker Change: So it may apply to us it would be a first for any antibiotics for antibiotics to follow that pathway.
Speaker Change: But our scientific team has taken a lot.
Speaker Change: It doesn't hurt to look absolutely Oh, Thank you guys very much taking the questions.
Jim: Thanks, so much Jim.
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.
Jim: Okay.
Jim: Yeah.
Jim: Yeah.