Q2 2025 Acurx Pharmaceuticals Inc Earnings Call

Speaker #1: Greetings and welcome to the Acurx Pharmaceuticals conference call to discuss second quarter 2025 financial results. At this time, all participants are in a listen-only mode.

Stacey: Greetings and welcome to the Acurx Pharmaceuticals to discuss the second quarter 2025 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. If anyone should require operator assistance, please press star zero on your telephone keypad. As a reminder, this conference is being recorded. It is now my pleasure to introduce Robert Shawah, Chief Financial Officer. Please go ahead.

Speaker #1: A question and answer session will follow the formal presentation. If anyone should require operator assistance, please press star zero on your telephone keypad. As a reminder, this conference is being recorded.

Speaker #1: It is now my pleasure to introduce Robert Shawah, Chief Financial Officer. Please go ahead.

Speaker #3: 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 second quarter of 2025, which is available on our website at acurxpharma.com.

Robert Shawah: Thank you, Stacey. Good morning and welcome to our call. This morning, we issued a press release providing financial results and company highlights for the second quarter of 2025, which is available on our website at acurxpharma.com. Joining me today is David Luci, President and CEO of Acurx Pharmaceuticals, who will give a corporate update and outlook. Following that, I will provide some highlights of the financials from the second quarter ended June 30th, and then turn the call back over to David for his closing remarks. As a reminder, during today's call, we will 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.

Speaker #3: Joining me today is David Luci, President and CEO of Acurx, who will give a corporate update and outlook. Following that, I'll provide some highlights of the financials from the second quarter ended June 30th, and then turn the call back over to Dave for his closing remarks.

Speaker #3: 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.

Speaker #3: 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.

Speaker #3: 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, August 11.

Robert Shawah: 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, August 11th, 2025. You are cautioned not to place undue reliance on these forward-looking statements, and Acurx Pharmaceuticals disclaims any obligation to update such statements at any time in the future. This conference call contains time-sensitive information that is accurate only as of the date of this live broadcast today, August 12th, 2025. I will now turn the call over to David. David?

Speaker #3: 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.

Speaker #3: This conference call contains time-sensitive information that's accurate only as of the date of this live broadcast today. August 12th, 2025. I'll now turn the call over to Dave.

Speaker #3: Dave?

Speaker #4: Thanks, Rob. Good morning, everyone, and thank you so much for joining us to review our financial results for the second quarter of '25. And also to hear some recent updates.

David Luci: Thanks, Rob. Good morning, everyone, and thank you so much for joining us to review our financial results for the second quarter of 2025 and also to hear some recent updates. Then we would be pleased to take any questions. First, I would like to briefly summarize just a few of our key activities for the second quarter, or in some cases, shortly thereafter. In April, we announced that the Indian Patent Office granted a new patent for our DNA polymerase IIIC inhibitors, which expires in December 2039, subject to extension. This constitutes another significant building block for our ongoing preclinical antibiotic development program of ACX-375C, which targets the treatment of infections caused by MRSA, VRE, DRSP, and anthrax. In May, we closed an equity line of credit with Lincoln Park Capital for up to $12 million of additional funding.

Speaker #4: 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 second quarter or, in some cases, shortly thereafter.

Speaker #4: 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.

Speaker #4: This constitutes another significant building block for our ongoing preclinical antibiotic development program of ACX-375C, which targets the treatment of infections caused by MRSA, VRE-DRST, and anthrax.

Speaker #4: In May, we closed an equity line of credit with Lincoln Park Capital for up to $12 million 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 the company's common stock.

David Luci: 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 the company's common stock, having a current exercise price for the Series A warrants to purchase 61,538 shares of the company's common stock at $65 per share, for Series B warrants to purchase 27,400 shares of our common stock at $65 per share, and for Series C warrants to purchase 66,667 shares of our common stock at $65.20 per share, and Series D warrants to purchase 66,667 shares of our common stock at an exercise price of $65.20 per share. Originals issued in July 2022 and May 2023 at a reduced exercise price of $12 per share.

Speaker #4: Having a current exercise price for the Series A warrants to purchase 61,538 shares of the company's common stock at $65.00 per share. For Series B warrants to purchase 27,400 shares of our common stock at $65.00 per share.

Speaker #4: And for Series C warrants to purchase 66,667 shares of our common stock at $65.20 per share. And Series D warrants to purchase 66,667 shares of our common stock at an exercise price of $65.20 per share.

Speaker #4: Originally issued in July '22 and May '23, at a reduced exercise price of $12.00 per share. In consideration for the company's agreement to issue new Series G1 warrants to purchase up to an aggregate of 321,180 shares of common stock with a five-year term.

David Luci: In consideration for the company's agreement to issue new Series G1 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 of 133,363 shares of our common stock with a five-year term, from shareholder approval, each at an exercise price of $8.50 per share. The gross proceeds to the company from the exercise of the existing warrants was approximately $2.7 million, with net proceeds of $2.5 million after deducting fees and expenses payable by the company. The warrant inducement transaction closed on June 20th. The company will continue its multi-step approach to raising capital through customary financing, warrant inducements, and public-private partnership opportunities going forward. In June, we announced the publication of our phase IIb clinical trial data for ibezapolstat and C.

Speaker #4: And new Series G warrants to purchase up to an aggregate 133,363 shares of our common stock with a five-year term. From shareholder approval, each at an exercise price of $8.50 per share.

Speaker #4: The gross proceeds to the company from the exercise of the existing warrants was approximately $2.7 million, with net proceeds of $2.5 million after deducting fees and expenses payable by the company.

Speaker #4: The warrant inducement transaction closed on June 20th. The company will continue its multi-step approach to raising capital through customary financings, warrant inducements, and public-private partnership opportunities going forward.

Speaker #4: In June, we announced the publication of our Phase IIB clinical trial data. For our desert pool stat and C. difficile infection. In Lancet Microbe, the world-leading microbiology research journal.

David Luci: difficile infection in The Lancet Microbe, the world-leading microbiology research journal. This publication is available on our website at acurxpharma.com. The Lancet Microbe summary highlighted ibezapolstat phase IIb data as follows, and I quote, "Results included high rates of clinical cure in ibezapolstat treated subjects with no recurrence. Furthermore, ibezapolstat 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. difficile infection." The Lancet publication also highlighted ibezapolstat's potential as a novel antibiotic treatment for C. difficile infection with high rates of clinical cure and sustained clinical cure, while preserving and restoring the healthy gut microbiota. The senior author, Professor Fannie Gary, PhD, University of Houston, and a co-author of the IDSA, Infectious Disease Society of America Treatment Guidelines for C. difficile infection, noted that current U.S.

Speaker #4: This publication is available on our website at acurxpharma.com. The Lancet Microbe summary highlighted our desert pool stats Phase II results as follows. And I quote, "Results included high rates of clinical cure and our desert pool stat treated subjects with no recurrence." Furthermore, our desert pool stat was found to be safe, well-tolerated, and associated with the preservation of key health-promoting bacteria responsible for bile acid homeostasis.

Speaker #4: A key component in preventing recurrent CDI," end quote. The Lancet publication also highlighted our desert pool stat's potential as a novel antibiotic treatment for CDI with high rates of clinical cure and sustained clinical cure.

Speaker #4: While preserving and restoring the healthy gut microbiota. The senior author, Professor Kevin Gary, PhD, University of Houston, and a co-author of the IDSA Infectious Disease Society of America treatment guidelines for C.

Speaker #4: difficile, infection, noted that current US and European treatment guidelines for CDI recommend only two antibiotics for treatment, oral vancomycin or fedaximycin. Vancomycin is most commonly used but has a low clinical cure rate of 70 to 92% and a sustained clinical cure rate of 42 to 71%.

David Luci: and European treatment guidelines for C. difficile infection recommend only two antibiotics for treatment: oral vancomycin or fidaximicin. Vancomycin is most commonly used but has a low clinical cure rate of 70% to 92% and a sustained clinical cure rate of 42% to 71%. Fidaximicin has fewer recurrences but low rates of clinical cure at about 84% and sustained clinical cure at 67%. Professor Gary further noted that both marketed antibiotics for C. difficile infection are associated with emerging antimicrobial resistance, stating that, quote, "The clinical need for a new antibiotic like ibezapolstat to treat C. difficile infection is underscored by a recently published study in Clinical Infectious Diseases by Dr. Curtis Donski of the Cleveland VA, and conducted in a hospital setting, documenting that C. difficile isolates with clinically relevant reduced fidaximicin susceptibility may emerge during therapy and spread to other patients.

Speaker #4: Fedaximycin has fewer recurrences but low rates of clinical cure at about 84% and sustained clinical cure at 67%. Professor Gary further noted that both marketed antibiotics for CDI are associated with emerging antimicrobial resistance.

Speaker #4: Stating and I quote, "The clinical need for a new antibiotic like our desert pool stat to treat CDI is underscored by a recently published study in Clinical Infectious Diseases by Dr. Curtis Donsky of the Cleveland VA.

Speaker #4: And conducted in a hospital setting, documenting that C. difficile isolates with clinically relevant reduced fedaximycin susceptibility may emerge during therapy and spread to other patients. The medical community should be aware of this alarming finding.

David Luci: The medical community should be aware of this alarming finding." Again, that's by Dr. 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 DNA polymerase IIIC inhibitors platform with data presented at the Federation of American Societies for Experimental Biology Scientific Conference, convened in the Netherlands on May 21st. A scientific presentation was provided by Mia Heuren, PhD, from Leiden University Medical Center, entitled, "A Unique Inhibitor Confirmation Selectively Targets the DNA Polymerase IIIC 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 a cell.

Speaker #4: End quote. Again, that's by Dr. Gary. Also, in June, we announced results from our collaboration with Leiden University Medical Center on its study of the mechanism of action of our polymerase 3C platform of inhibitors, with data presented at the Federation of American Societies for Experimental Biology Scientific Conference.

Speaker #4: Convened in the Netherlands on May 21st. A scientific presentation was provided by Mia Urum, 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 #4: In August, we implemented a one-for-twenty reverse stock split in an effort to comply with the NASDAQ listing maintenance requirements. We continue to identify and pursue funding opportunities for our Phase III clinical trial program for our desert pool stat and consider alternative financial pathways to achieve success.

David Luci: In August, we implemented a one-for-20 reverse stock split in an effort to comply with the NASDAQ listing maintenance requirements. We continue to identify and pursue funding opportunities for our phase III clinical trial program for ibezapolstat and consider alternative financial pathways to achieve success. We have several initiatives underway to this end and will report in future updates as appropriate. As we've continually reported, ibezapolstat clinical results continue to demonstrate its leadership in the field in a serious and potentially life-threatening infectious disease called C. difficile infection that the U.S. CDC categorizes as an urgent threat and calls for new classes of antibiotics for initial treatment that also have a low incidence of recurrence. Ibezapolstat has FDA QIDP and FastTrack designations for the treatment of C. difficile infection. We also believe that ibezapolstat, if approved, could make a favorable economic impact by reducing the overall annual U.S.

Speaker #4: We have several initiatives underway to this end. And we'll report in future updates as appropriate. As we've continually reported, our desert pool stat clinical results continue to demonstrate its leadership in the field.

Speaker #4: In a serious and 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 that also have a low incidence of recurrence.

Speaker #4: Our desert pool stat has FDA QIDP and fast-track designations for the treatment of CDI. We also believe that our desert pool stat, if approved, could make a favorable economic impact by reducing the overall annual US cost burden for C.

David Luci: cost burden for C. diff infection of approximately $5 billion a year, of which $2.8 billion 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 ibezapolstat'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. Now back to our CFO, Robert Shawah, to guide you through the highlights of our financial results for the second quarter of 2025. Robert?

Speaker #4: diff infection of approximately $5 billion a year. Of which $2.8 billion 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 our desert pool stats 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.

Speaker #4: And now back to our CFO, Robert Shawah, to guide you through the highlights of our financial results for the second quarter of 2025. Rob?

Speaker #3: Thanks, Dave. Our financial results for the second quarter, ended June 30, 2025, were included in our press release issued earlier this morning. The company ended the quarter with cash totaling $6.1 million, compared to $3.7 million as of December 31, 2024.

Robert Shawah: Thanks, Dave. Our financial results for the second quarter ended June 30, 2025, were included in our press release issued earlier this morning. The company ended the quarter with cash totaling $6.1 million, compared to $3.7 million as of December 31, 2024. During the second quarter, the company raised a total of approximately $3.4 million of gross proceeds through purchases under the equity line of credit and a warrant inducement agreement. Research and development expenses for the three months ended June 30 were $0.5 million, compared to $1.8 million for the three months ended June 30, 2024, a decrease of $1.3 million. The decrease was due primarily to a decrease in manufacturing costs of $0.3 million and a decrease in consulting costs of $1 million as a result of the prior year trial-related expenses.

Speaker #3: During the second quarter, the company raised a total of approximately $3.4 million in gross proceeds through purchases under the equity line of credit and a warrant inducement agreement.

Speaker #3: Research and development expenses for the three months end of June 30th were $0.5 million compared to $1.8 million for the three months end of June 30th, 2024.

Speaker #3: A decrease of $1.3 million. The decrease was due primarily to a decrease in manufacturing costs of $0.3 million and a decrease in consulting costs of $1 million.

Speaker #3: As a result of the prior year trial-related expenses, for the six months ended June 30, 2025, research and development expenses were $1.1 million versus $3.4 million for the six months ended June 30, 2024.

Robert Shawah: For the six months ended June 30, 2025, research and development expenses were $1.1 million versus $3.4 million for the six months ended June 30, 2024. The decrease of $2.3 million was primarily due to a reduction of $0.6 million in manufacturing costs and a $1.7 million decrease in consulting costs due to higher trial-related costs in the prior year. General and administrative expenses for the three months ended June 30, 2025, were $1.7 million compared to $2.3 million for the three months ended June 30, 2024, a decrease of $0.6 million. The decrease was primarily due to a $0.7 million decrease in share-based compensation offset by a $0.1 million increase in professional fees. For the six months ended June 30, 2025, general and administrative expenses were $3.3 million versus $5.1 million for the six months ended June 30, 2024, a decrease of $1.8 million.

Speaker #3: The decrease of $2.3 million was primarily due to a reduction of $0.6 million in manufacturing costs and a $1.7 million decrease in consulting costs, attributed to higher trial-related costs in the prior year.

Speaker #3: General and administrative expenses for the three months end of June 30th, 2025, were $1.7 million compared to $2.3 million for the three months end of June 30th, 2024.

Speaker #3: A decrease of $0.6 million. The decrease was primarily due to a $0.7 million decrease in share-based compensation, offset by a $0.1 million increase in professional fees.

Speaker #3: For the six months ended June 30, 2025, general and administrative expenses were $3.3 million, compared to $5.1 million for the six months ended June 30, 2024.

Speaker #3: A decrease of $1.8 million. The decrease was due primarily to a $0.6 million decrease in professional fees and a $1.2 million decrease in share-based compensation.

Robert Shawah: The decrease was due primarily to a $0.6 million decrease in professional fees and a $1.2 million decrease in share-based compensation. The company reported a net loss of $2.2 million or $1.89 per diluted share for the three months ended June 30, 2025, compared to a net loss of $4.1 million or $5.21 per diluted share for the three months ended June 30, 2024, and a net loss of $4.4 million or $4.01 per diluted share for the six months ended June 30, 2025, compared to a net loss of $8.5 million or $10.84 per diluted share for the six months ended June 30, 2024, all for the reasons previously mentioned. The company had a reverse split adjusted 1,470,352 shares outstanding as of June 30, 2025. With that, I will turn the call back over to Dave.

Speaker #3: The company reported a net loss of $2.2 million or $1.89 per diluted share for the three months end of June 30th, 2025, compared to a net loss of $4.1 million or $5.21 per diluted share for this three months end of June 30th, 2024.

Speaker #3: And a net loss of $4.4 million or $4.01 per diluted share for the six months end of June 30th, 2025, compared to a net loss of $8.5 million or $10.84 per diluted share for the six months end of June 30th, 2024.

Speaker #3: All for the reasons previously mentioned. The company had a reverse split adjusted $1 million 470 thousand 352 shares outstanding as of June 30th, 2025.

Speaker #3: With that, I'll turn the call back over to Dave.

Speaker #4: Thanks, Rob. Thanks to all of you for joining us today. And now back to our operator, Stacy, to open the call for questions.

David Luci: Thanks, Rob, and to all of you for joining us today. Now back to our operator, Stacey, to open the call for questions. Stacey?

Speaker #4: Stacy?

Speaker #1: Thanks. 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.

Stacey: 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. For participants using 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 #1: A confirmation tone will indicate your line is in the question queue. You may press *2 to remove yourself from the queue. For participants who speak your equipment, it may be necessary to pick up your handset before pressing the star key.

Speaker #1: First question, Jim Malloy with Alliance Global Partners, please go ahead.

Speaker #5: Hey, guys. Good morning. Thank you for taking my questions. Just a quick technical call. Thank you. Looking at the OpEx coming down, you know, in line, certainly with cash preservation as a high priority.

Jim Malloy: Hey, guys. Good morning. Thank you for taking my questions. Just a typical call. Thank you. Looking at the OpEx coming down, in line, certainly with cash preservation, a high priority, is this a trend we should expect to continue through the rest of 2025 and 2026? Then maybe following up on that, I know it's a bit up in the air and a little out of your hands, but as an outsider looking in, when should we anticipate potentially either a partnership or potentially a partnership to be signed? Is that something that 2025 or you're looking at 2025, 2026, and then getting these trials up and running for ibezapolstat. Thank you.

Speaker #5: This is a trend we should expect to continue through the rest of '25 and '26. And then maybe following up on that, I know it's a bit up in the air.

Speaker #5: And a little out of your hands, but as an outsider looking in, when should we anticipate potentially either a partnership or a potential partnership to be signed?

Speaker #5: That's something that '25. Are you looking for 2025, 2026? And then, you know, getting these trials up and running for Bezza. Thank you.

Speaker #4: Sure, Jim, I'll start with your second question. I'll ask you to repeat the first, but for your second question, you know, it could be any time here in the second half.

David Luci: Sure, Jim. I will start with your second question. I will ask you to repeat the first. For your second question, it could be any time here in the second half in terms of a private partnership if we are able to announce something like that. In terms of, I use the word partnership broadly to include government agencies because that is their preference. They like to say that they are not providing grants. They are entering into partnerships, and they expect their incubator companies to be good partners. That process is ongoing and will certainly slip into 2026, given the dynamics that are going on in Washington. The federal government's year-end is September 30th.

Speaker #4: 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.

Speaker #4: Because that's their preference. They like to say that they're not providing grants. They're entering into partnerships and they expect their incubator companies to be good partners.

Speaker #4: So that process is ongoing. And we'll certainly slip into 2026 given the dynamics that are going on in Washington. So the federal government's year-end is September 30th.

Speaker #4: 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 the calendar year-end—as being likely the time when funding for the new fiscal year gets appropriated.

David Luci: As I understand it through the folks we work with in Washington, they are expecting a continuing resolution toward the end of the year, kind of the usual annual punt to kind of 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. Those are all going very well, I would say. We are confident that we will have success in these regards. I think also particularly with the government, it is going to take time. Could I ask you to ask the first question again, please?

Speaker #4: You know, through the starting with the House Ways and Means Committee. So those are all going very well. I would say. And we're confident that we will have success in these regards.

Speaker #4: You know, but I think particularly with the government, it's going to take time. But could I ask you to ask the first question again, please?

Speaker #5: Yeah, of course. And I see that you guys are, you know, preserving cash, operating expenses coming down nicely in line with your expectation to preserve capital.

Jim Malloy: Yes, of course. I see that you guys are, you know, preserving cash, operating expenses coming down nicely in line with your expectation to preserve capital. Is that something we should expect a trend we should continue through the second half of 2025 and into 2026?

Speaker #5: Is that something we should expect, a trend we should continue through the second half of '25? And into '26?

Speaker #4: Oh, absolutely. Yeah, we're trending tremendously. What I would say is, you know, when you're seeing things like G&A expenses that we report on these earnings calls, you know, that's a different number than cash flow.

David Luci: Oh, absolutely. Yeah, we are trending tremendously. What I would say is, you know, when you are seeing things like G&A expenses that we report on these earnings calls, you know, that is a different number than cash flow. That includes cash and non-cash items. So our cash burn is, you know, it is, you know, down to close to $400,000 a month at this point. We expect to continue that process. Now, there are some clinical strategy things that we will be announcing in the near future that we are currently considering for a new, very small clinical trial that we can handle financially without a lot of heavy lift on our end. But we will be able to come out with more information on that next quarter after we get in front of our board of directors.

Speaker #4: That includes cash and non-cash items. So our cash burn is, you know, it's, you know, down to close to $400,000 a month at this point.

Speaker #4: And we expect to continue that process. Now, there are some clinical strategy things that we will be announcing in the near future that we're currently considering for a new, very small clinical trial that we can handle financially without a lot of heavy lift on our end.

Speaker #4: But we'll be able to come out with more information on that next quarter after we get in front of our board of directors.

Speaker #5: Excellent. And as always, excellent work on keeping the accruals in line. Thank you, Dave.

Jim Malloy: Excellent. As always, excellent work on keeping the accruals in line. Thank you, David.

Speaker #4: Thank you so much.

David Luci: Thank you so much. Thank you, Jim.

Speaker #5: Thank you, Jim.

Speaker #1: Once again, if you would like to ask a question, please press star one on your telephone keypad. Next question comes from Matthew Keller with HD Wainwright.

Stacey: Once again, if you would like to ask a question, please press star one on your telephone keypad. Next question comes from Matthew Keller with HB Wayne Right. Please proceed.

Speaker #1: Please proceed.

Speaker #6: Yeah. Hey, good morning, everyone. And congrats on the quarter. So just two quick ones from us. Obviously, the publication of the two big data sets was very nice.

Matthew Keller: Yeah. Hey, good morning, everyone, and congrats on the quarter. Just two quick ones from us. Obviously, the publication of the phase IIb data was very nice. I was wondering if there were any additional feedback that you got from either the physician community or KOL community on that publication. The second question I had for you is kind of related to maybe the previous questions, but are there any other rate-limiting steps ahead of the upcoming phase III studies that we should be thinking about?

Speaker #6: I was wondering if there were any additional feedback that you got from either physician community or K-Well community on that publication. And then the second question I had for you is kind of related to maybe the previous questions, but are there any other rate limiting steps ahead of the upcoming Phase III studies that we should be thinking about?

Speaker #4: 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 the, you know, as we've talked about, the fill finish.

David Luci: Thank you, Matthew, for the questions. For rate-limiting steps, the only one, and it is not even really a long rate limit, would be the, as we have talked about, the fill-finish of the ibezapolstat supply into the phase III trials. We have been reluctant to do fill-finish because once you do, then your drug is dated. We want to forestall that to maximize the amount of time we have to use the ibezapolstat without it becoming obsolete. So that may be a couple-of-month process. It is nothing significant. Everything else is literally ready. The European Medicines Agency and FDA, amazingly, agreed entirely on the identical same protocol for the two trials. That has gone quite well.

Speaker #4: Of the Ibexa pool stat, supply into the Phase III trials. We've been reluctant to do fill-finish because once you do, then your drug is dated.

Speaker #4: And we want to forestall that to maximize the amount of time we have to use the Ibeza pool stat without it becoming obsolete. So, that may be a couple of months process.

Speaker #4: It's nothing significant, but everything else is literally ready. The European Medicines Agency and FDA amazingly agreed entirely on the identical same protocol for the two trials.

Speaker #4: So that's gone quite well.

Speaker #6: Yeah. Okay. Great. Makes sense.

Matthew Keller: Yeah. Okay. Great. Makes sense.

Speaker #4: Thank you.

David Luci: Thank you.

Speaker #1: There There are no further questions. This does conclude today's teleconference. Thank you for your participation. You may now disconnect your line.

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

David Luci: Thank you, Stacey.