Q2 2024 Acurx Pharmaceuticals Inc Earnings Call

Speaker Change: Greetings. Welcome to the Acurx Pharmaceuticals second quarter 2024 financial results. At this time all participants are in listen-only mode. Question and answer session will follow the formal presentation.

Unknown Attendee: and financial results. At this time, all participants are in listen-only mode. A question and answer session will follow the formal presentation.

Operator: At this time, all participants are in listen-only mode. The question and answer session will follow the formal presentation. If anyone should require operator assistance during the conference, please press star zero from your telephone keypad. Please note, this conference is being recorded. At this time, I'll now turn the conference over to Rob Bawa, Chief Financial Officer. Rob, you may begin.

Unknown Attendee: If anyone should require operator assistance during the conference, please press star zero from your telephone keypad. Please note, this conference is being recorded.

Speaker Change: If anyone should require operator assistance during the conference, please press star zero from your telephone keypad. Please note this conference is being recorded.

Rob: At this time, we'll now turn the conference over to Rob, Chief Financial Officer. Rob, you may begin.

Speaker Change: At this time, I'll now turn the conference over to Rob Bawa, Chief Financial Officer. Rob, you may begin.

Unknown Attendee: Thank you, Rob.

David Luci: 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 2024, which is available on our website at AcurxFarma.com. Joining me today is Dave Luci, President and CEO, who will give a corporate update and outlook. After that, I'll provide some highlights to the financials from the quarter end of June 30th, 2024, and then turn the call back over to Dave for his closing remarks.

Rob Bawa: 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 2024, which is available on our website at acurxpharma.com. Joining me today is Dave Luci, President and CEO, who will give a corporate update and outline. After that, I'll provide some highlights of the financials for the quarter ended June 30th, 2024, and then turn the call back over to Dave for his closing remarks.

Speaker Change: Thank you, Rob. Good morning and welcome to our call. This morning, we issued a press release providing financial results and company highlights for the second quarter, 2024, which is available on our website at acurxpharma.com.

Speaker Change: Joining me today is Dave Lucci, President and CEO , who will give a corporate update and outlook. After that, I'll provide some highlights of the financials from the quarter ended June 30th, 2024, and then turn the call back over to Dave for his closing remarks.

Unknown Attendee: As a reminder, during today's call, we'll be making certain forward-looking statements. These forward-looking statements 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 from those contained in the forward-looking statements. Investors should consider these risks and other information described in our filings made with the Securities and Exchange Commission, including our quarterly report on Form 10-Q, which we filed on Thursday, August 8, 2024. Your question not to place any undue reliance on these forward-looking statements, and Acurx disclaims any obligation to update such statements at any time in the future.

Rob Bawa: As a reminder, during today's call, we'll be making certain forward-looking statements. These forward-looking statements 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 from those contained in the forward-looking statement. 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 on Thursday, August 8th.

Speaker Change: As a reminder, during today's call, we'll be making certain forward-looking statements. These forward-looking statements 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.

Speaker Change: That may cause actual results to differ materially from those contained in the forward-looking statements.

Speaker Change: Investors should consider these risks and other information described in our filings made with the Securities and Exchange Commission.

Speaker Change: including our quarterly report on Form 10-Q which we filed on Thursday, August 8, 2024. Your question not to place any undue reliance on these forward-looking statements and Acurx disclaims any obligation to update such statements at any time in the future.

Rob Bawa: 2024. Your question not to place any undue reliance on these forward-looking statements, and Acurx disclaims any obligation to update such statements at any time. This conference call contains time-sensitive information that's accurate only as of the date of this live broadcast, today, August 9th, 2021. I'll now turn the call over to Dave. Dave?

Unknown Attendee: This conference call contains time-sensitive information that's accurate only as of the date of this live broadcast today, August 9, 2024.

Speaker Change: This conference call contains time-sensitive information that's accurate only as of the date of this live broadcast today, August 9th, 2024.

David Luci: I'll now turn the call over to Dave. Dave?

Speaker Change: I'll now turn the call over to Dave. Dave?

David Luci: Thanks, Rob.

Dave Luci: Thanks, Rob. Good morning, everyone, and thanks for joining us to review our financial results for the second quarter of 2024 and also to hear some very exciting recent updates. We'll be pleased to take any questions. First, I'll summarize some of our key activities for the second quarter, or in some cases, where we are at. In April, we completed a successful end of Phase 2 meeting with the FDA, confirming Phase 3 readiness for ibuprofen, our lead antibiotic candidate, to enter Phase 3 clinical trials for the treatment of C. difficile infection.

David Luci: Good morning, everyone, and thanks for joining us to review our financial results for the second quarter of 2024. Also, to hear some very exciting recent updates, then we'll be pleased to take any questions. First, I'll summarize some of our key activities for the second quarter, or in some cases shortly thereafter. In April, we completed a successful end of phase two meeting with the FDA, confirming phase three readiness for our metaphors that are lead in a biotic candidate to enter phase three clinical trials for the treatment of C-dipicycle infection. Agreement with FDA was reached on key elements to move forward with our international Phase three clinical trial program.

Dave Lucci: Thanks, Rob. Good morning, everyone, and thanks for joining us to review our financial results for the second quarter of 2024, and also to hear some very exciting recent updates. Then we'll be pleased to take any questions.

Dave Lucci: First, I'll summarize some of our key activities for the second quarter, or in some cases, shortly thereafter.

Speaker Change: In April , we completed a successful end of Phase II meeting with the FDA, confirming Phase III readiness for ibuprofen, our lead antibiotic candidate, to enter Phase III clinical trials for the treatment of C. difficile infection.

Dave Luci: Agreement with FDA was reached on key elements to move forward with our international phase 3 clinical trial program; agreement was also reached with FDA on a complete non-clinical and clinical development plan for filing a new drug application or NDA for marketing approval. We've since continued activities to advance Ibeza-Polstad into international phase three clinical trials for the treatment of C. difficile infection. In parallel, we're also preparing to submit requests for regulatory guidance to initiate clinical trials in the European Union, the United Kingdom, Japan, and Canada. Also, in April, we attended the European Society of Microbiology and Infectious Diseases, or ESMID, Scientific Conference.

Speaker Change: Agreement with FDA was reached on key elements to move forward with our International Phase III Clinical Trial Program.

David Luci: Agreement was also reached with FDA on a complete non-clinical and clinical development plan for filing of a New Drug Application or NDA for marketing approval. We've soon continued activities to advance a vesicles that into international phase three clinical trials for the treatment of C-dipicycle infection. In parallel, we're also preparing to submit requests for regulatory guidance to initiate clinical trials in the European Union, United Kingdom, Japan, and Canada.

Speaker Change: The agreement was also reached with FDA on a complete non-clinical and clinical development plan for filing of a new drug application, or NDA, for marketing approval.

Speaker Change: We've since continued activities to advance Ibeza Polstat into international phase 3 clinical trials for the treatment of C. difficile infection.

Speaker Change: In parallel, we're also preparing to submit requests for regulatory guidance to initiate clinical trials in the European Union, the United Kingdom, Japan, and Canada.

David Luci: Also in April, we attended the European Society of Microbiology and Infectious Disease or Estimates Scientific. Dr. Kevin Garry provided an oral presentation of our Phase 2 data entitled, "A Phase 2 Randomized Double Blind Study of Life as a Post" that compared with vancomycin for the treatment of C. Difficile infection. Dr. Garry is Professor in Chair, University of Houston College of Pharmacy, and the Principal Investigator for Microbiology and Microbiome aspects of the Life as a Post at Clinical Trial Program, and he's a scientific advisory board member for Acurx. The oral presentation includes additional analyses of clinical and microbiological data and is available on our website at acurxforma.com.

Speaker Change: Also in April , we attended the European Society of Microbiology and Infectious Disease, or ESMID, Scientific Conference.

Dr. Kevin Derry: Dr. Kevin Derry provided an oral presentation of our Phase 2 data entitled A Phase 2 Randomized Double Blind Study of Life as a Pulse that, compared with vagomice and for the treatment of, Dr. Gary is Professor in Chair, University of Houston College of Pharmacy and the Principal Investigator for Microbiology and Microbiome Aztecs of the Ivesipolostat Clinical Trial Program, and he's a scientific advisory board member for The oral presentation includes additional analyses of clinical and microbiological data and is available on our website at Acurx Pharmaceuticals.

Speaker Change: Dr. Kevin Gehry provided an oral presentation of our Phase II data entitled, A Phase II Randomized Double-Blind Study of Ibizepolstat Compared with Vancomycin for the Treatment of C. difficile Infection.

Dr. Gary: Dr. Gary is Professor and Chair, University of Houston College of Pharmacy, and the Principal Investigator for Microbiology and Microbiome Aspects of the Ibizapolistat Clinical Trial Program, and he's a Scientific Advisory Board Member for Acurx.

Speaker Change: The oral presentation included additional analyses of clinical and microbiological data and is available on our website at acurxpharma.com.

David Luci: The complete Phase 2 results are being prepared for submission to a prominent scientific journal for publication.

Dr. Kevin Derry: The complete Phase II results are being prepared for submission to a prominent scientific journal for publication. Also, in July, results from the Advenza-Pulistec Phase II clinical trial in patients with C. difficile infection were presented at the 17th Biennial Congress of the Anaerobic Society of the Americas by Taryn Eubank, PharmD, Research Assistant Professor, University of Houston College of Pharmacy. And Taryn's oral presentation was entitled Clinical Efficacy of Ibezafolstat in CDI. See for the seal infection.

Speaker Change: The complete Phase II results are being prepared for submission to a prominent scientific journal for publication.

David Luci: Also in July, results from the Avezopols that Phase 2 Clinical Trial and Patients with C. Difficile infection were presented at the 17 Biennial Congress of the Anural Society of the Americas by Karen Yubag, Farm D, Research Assistant Professor University of Houston College of Pharmacy, and her Karen's oral presentation was entitled, Clinical Efficacy of Avezopols that in CDI, C. difficile infection results from Phase 2 trials. Also in July, very timely given our late-stage development progress, the United States Patent and Trademark Office or USPTO granted us a new patent for Avezopols that which specifically encompasses the treatment of C.

Speaker Change: Also in July , results from the ibezapolstat phase 2 clinical trial in patients with C. difficile infection were presented at the 17th Biennial Congress of the Anaerobic Society of the Americas.

Taryn Eubank: by Taryn Eubank, PharmD, Research Assistant Professor, University of Houston College of Pharmacy, and Taryn's oral presentation was entitled Clinical Efficacy of Ibezafolstat in CDI.

Taryn Eubank: C. difficile infection. Results from Phase 2 trials.

Dave Luci: Results from phase 2 trials. Also in July, and very timely given our late-stage development progress, the United States Patent and Trademark Office, or USPTO, granted us a new patent for ibezafolstat, which specifically encompasses the treatment of C. difficile infection while reducing recurrence of infection and improving the health of the gut microbiome. And finally, some late-breaking news today.

Speaker Change: Also in July and very timely given our

Speaker Change: The United States Patent and Trademark Office, or USPTO.

Speaker Change: granted us a new patent for ibezafolstat which specifically encompasses the treatment of C. difficile infection while reducing recurrence of infection and improving the health of the gut microbiome.

David Luci: difficile infection while reducing recurrence of infection and improving the health of the gut microbiome. This patent expires in June 2042, and we think will provide an important downstream competitive advantage.

Speaker Change: This patent expires in June 2042 and we think will provide an important downstream competitive advantage.

David Luci: And finally, some late-breaking news today. Following our successful end-of-finished 2 clinical meeting with the FDA, which confirmed our Phase 3 clinical trial readiness, and according to FDA regulatory requirements, we submitted our request to FDA for a meeting to review our manufacturing processes and specifications for drug substance and final product and packaging. Typically referred to as CMC or a chemistry manufacturing patrols for our Phase 3 clinical trials. We anticipate FDA to grant the meeting in the fourth quarter. So now we have further momentum as we continue to seek one or more strategic transactions for the further development and potential commercialization of our median and biotic candidate at Avezopols that territory or globally in parallel with ongoing preparation for Phase 3 clinical trials.

Dave Luci: Following our successful end-of-Phase II clinical meeting with the FDA, which confirmed our phase 3 clinical trial rate, and according to FDA regulatory requirements, we submitted our request to FDA for a meeting to review our manufacturing processes and specifications for drug substance and final product impacts, definitely referred to as CMC or a chemistry manufacturing patrol, for our Phase III clinical trial. We anticipate FDA to grant the meeting in the fourth quarter. So now we have further momentum as we continue to seek one or more strategic transactions for the further development and potential commercialization of our leading antibiotic candidate, ibezafolstaz.

Speaker Change: And finally, some late-breaking news today. Following our successful end-of-Phase II clinical meeting with the FDA, which confirmed our Phase III clinical trial readiness,

Speaker Change: And, according to FDA regulatory requirements, we submitted our request to FDA for a meeting to review our manufacturing processes and specifications for drug substance and final product and packaging.

Speaker Change: typically referred to as CMC, or Chemistry, Manufacturing, and Controls, for our Phase 3 clinical trials. We anticipate FDA to grant the meeting in the fourth quarter.

Speaker Change: So now we have further momentum as we continue to seek one or more strategic transactions for the further development and potential commercialization of our leading antibiotic candidate, Abesif-Bolestat, territory or globally, in parallel with ongoing preparation for phase three clinical trials.

Dave Luci: Territory or globally in parallel with ongoing preparation for phase three clinical trials. We will provide a detailed update on our partnership transactions if and when we reach agreement with a third party. Throughout the rest of this year, we'll continue to roll out our phase two results in either oral presentations or scientific posters, or in some cases both, which will include results from new analyses as data becomes available at various prominent scientific conferences, including the World Antimicrobial Resistance Conference in Philadelphia this September.

David Luci: We will provide a detailed update on our partnership transactions if and when we reach agreement with the third party. Throughout the rest of this year, we'll continue to roll out our Phase 2 results in either oral presentations or scientific posters, or in some cases both, which will include results from new analyses as data becomes available at various prominent scientific conferences, including the World Antimicrobial Resistance Conference in Philadelphia. This, also in September, is the 8th International Clostridium difficile Symposium in Bled, Slovenia, which is the premier global venue for the review of Clostridium difficile research.

Speaker Change: We will provide a detailed update on our partnership transactions if and when we reach agreement with a third party.

Speaker Change: Throughout the rest of this year, we'll continue to roll out our Phase II results in either oral presentations or scientific posters, or in some cases both, which will include results from new analyses as data becomes available at various prominent scientific conferences.

Speaker Change: including the World Antimicrobial Resistance Conference in Philadelphia this September .

Dave Luci: Also in September is the 8th International Seed Difficile Symposium and Blad Slalini, which is the premier global venue for the review of Secretly See-A-Lease. And in October, we'll be presenting at the annual meeting of the Infectious Disease Society of America, or ID Week, in Los Angeles. As we've continually reported, Ibiza Pulse Lab clinical results continue to outperform in a serious and potentially life-threatening infectious disease caused by C. difficile bacteria, that the Center for Disease Control categorizes as an urgent threat and calls for new classes of antibiotics for initial treatment that also have a low incidence of recurrence.

Speaker Change: Also in September is the 8th International C. difficile Symposium in Bled, Slovenia, which is the premier global venue for the review of C. difficile research.

David Luci: In October, we'll be presenting at the annual meeting of the Infertum Disease Society in America or ID League in Los Angeles. As we continually report it, it does oppose that clinical results continued to outperform in a serious and potentially life threat in an infectious disease caused by a seed of a seal bacteria that the Center for Disease Control categorizes as an urgent threat and calls for new classes of antibiotics for initial treatment that also have a low incidence of recurrence. A vesicle that also has FDA fast-track designation for treatment of seed of a seal infection.

Speaker Change: And in October , we'll be presenting at the annual meeting of the Infectious Disease Society of America, or ID Week, in Los Angeles.

Speaker Change: As we've continually reported, ibuprofen clinical results continue to outperform in a serious and potentially life-threatening infectious disease caused by C. difficile bacteria.

Speaker Change: that the Center for Disease Control categorizes as an urgent threat and calls for new classes of antibiotics for initial treatment that also have a low incidence of recurrence.

Dave Luci: It also has FDA fast-track designation for the treatment of C. difficile infection. Additionally, we believe, as a plus, that if approved, it could make a favorable impact by reducing the cost burden of recurrence to the seal infection in our U.S. health care system, which is estimated at $4.7 billion annually. We do believe the best is yet to come, and now back to our CFO Rob Schallon to guide you through the highlights of our financial results for the second quarter of 2024.

Speaker Change: Adveza Pulse that also has FDA fast-track designation for treatment of C. difficile infection.

David Luci: Additionally, we believe a vesicles that, if approved, could make a favorable impact by reducing the cost burden of recurrence-y difficile infection on our U.S. healthcare system, which is estimated at $4.7 billion annually.

Speaker Change: Additionally, we believe Ibezaplostat, if approved, can make a favorable impact by reducing the cost burden of recurrent C. difficile infection on our U.S. healthcare system, which is estimated at $4.7 billion annually.

David Luci: We do believe the best is yet to come.

Rob Bawa: Our financial results for the second quarter and June 30th were included in our press release issued earlier this morning. The company ended the quarter with cash totaling $6.4 million, compared to $7.5 million as of December 31, 2023. During the second quarter, the company sold an additional 133,066 shares under its ATM financing program, with gross proceeds of approximately $0.3 million. Research and Development Expenses for the three months ended June 30, 2024 were $1.8 million compared to $1.7 million for the three months ended June 30, 2023.

Rob: And now back to our CFO, Rob Schallant, to guide you through the highlights of our financial results for the second quarter of 2024. Rob?

Speaker Change: We do believe the best is yet to come.

Rob Shawah: And now back to our CFO , Rob Shawah, to guide you through the highlights of our financial results for the second quarter of 2024. Rob?

Rob: Thanks, Dave.

Rob: Our financial results for the second quarter and the June 30th were included in our press release issued earlier this morning. The company ended the quarter with cash totaling $6.4 million, compared to $7.5 million as of December 31, 2023. During the second quarter, the company sold an additional 133,066 shares under its ATM financing program, with gross proceeds of approximately $0.3 million. Research and development expenses for a three-month ended June 30th, 2024, were $1.8 million compared to $1.7 million for a three-month ended June 30th, 2023. The increase was due primarily to an increase in manufacturing related costs during the quarter of $0.4 million, partially offset by a reduction in consulting fees of $0.3 million.

Rob Shawah: Thanks, Dave. Our financial results for the second quarter and the June 30th were included in our press release issued earlier this morning.

Rob Shawah: The company ended the quarter with cash totaling $6.4 million, compared to $7.5 million as of December 31, 2023.

Speaker Change: During the second quarter, the company sold an additional 133,066 shares under its ATM financing program, with gross proceeds of approximately $0.3 million.

Speaker Change: Research and development expenses for the three months ended June 30th, 2024 were 1.8 million dollars compared to 1.7 million dollars for three months ended June 30th, 2023.

Speaker Change: The increase was due primarily to an increase in manufacturing-related costs during the quarter of $0.4 million, partially offset by a reduction in consulting fees of $0.3 million.

Rob: For the six months ended June 30th, 2024, research and development expenses were $3.4 million compared to $2.8 million for the six months ended June 30th, 2023. An increase of $0.6 million, primarily due to a $0.8 million increase in manufacturing related costs, offset by a $0.2 million decrease in consulting related fees. General administrative expenses for a three-month ended June 30th, 2024, were $2.3 million compared to $1.7 million for a three-month ended June 30th, 2023. An increase of $0.6 million. The increase was primarily due to $0.3 million increased in professional fees and a $0.2 million increased in non-cash share-based compensation-related costs.

Rob Bawa: The increase was due primarily to an increase in manufacturing-related costs during the quarter of $0.4 million, partially offset by a reduction in consulting fees of $0.3 million. For the six months ended June 30, 2024, research and development expenses were $3.4 million, compared to $2.8 million for the six months ended June 30, 2023, an increase of $0.6 million, primarily due to a $0.8 million increase in manufacturing-related costs offset by a $0.2 million decrease in consulting-related costs.

Speaker Change: For the six months ended June 30, 2024,

Speaker Change: compared to $2.8 million for the 6 months ended June 30, 2023, an increase of $0.6 million primarily due to $2.8 million increase in manufacturing related costs offset by $0.2 million decrease in consulting related fees.

Rob Bawa: General and Administrative Expenses for the three months ended June 30, 2024, were $2.3 million, compared to $1.7 million for the three months ended June 30, 2023, an increase of $0.6 million. The increase was primarily due to a $0.3 million increase in professional fees and a.2 million increase in non-cash share-based compensation for the six months ended June 30, 2024. General and administrative expenses were $5.1 million compared to $3.6 million for the six months ended June 30, 2023, an increase of $1.5 million. The increase was primarily due to a $1 million increase in professional fees. $0.4 million increase in non-cash base conversation costs and a $0.1 million increase in legal costs.

Speaker Change: General and administrative expenses for the three months ended June 30, 2024 were 2.3 million dollars compared to 1.7 million dollars for the three months ended June 30, 2023, an increase of 0.6 million.

Speaker Change: The increase was primarily due to a $0.3 million increase in professional fees.

Speaker Change: and a $0.2 million increase in non-cash, share-based compensation related costs.

Rob: For the six months ended June 30th, 2024, general administrative expenses were $5.1 million compared to $3.6 million for the six months ended June 30th, 2023. and increase of $1.5 million. The increase was primarily due to a $1 million increase in professional fees, a $0.4 million increase in non-cash share-based compensation costs, and a $0.1 million increase in legal costs. The company reported in that loss of $4.1 million, or $0.26 per diluted share for the 3 months ended June 30, 2024, compared to a net loss of $3.4 million or $0.28 per diluted share for the 3 months ended June 30, 2023.

Speaker Change: For the six months ended June 30, 2024.

Speaker Change: General and Administrative Expenses were $5.1 million compared to $3.6 million for the six months ended June 30, 2023, an increase of $1.5 million.

Speaker Change: The increase was primarily due to a $1 million increase in professional fees.

Speaker Change: $0.4 million increase in non-cash year-based compensation costs and a $0.1 million increase in legal costs.

Rob Bawa: The company reported a net loss of $4.1 million, 26 cents per deluded share. [inaudible] for the three months ended June 30, 2024. Compared to a net loss of $3.4 million, or 28 cents per diluted share for the three months and June 30, 2020, and a net loss of $8.5 million, or $54 cents per share for the six months ended June 30, 2024, compared to a net loss of $6.3 million, or $0.53 per share. All for the reasons previously mentioned. The company had 15,996,168 shares outstanding as of June 30, 2021.

Speaker Change: The company reported a net loss of $4.1 million.

Speaker Change: or $0.26 per diluted share for the three months ended June 30, 2024 compared to a net loss of $3.4 million or $0.28 per diluted share for the three months ended June 30, 2023.

Rob: And a net loss of $8.5 million or $0.54 cents per share for the 6 months ended June 30, 2024, compared to a net loss of $6.3 million or $0.53 cents per share, all for the reasons previously mentioned. The company had $15 million, 996,168 shares outstanding as of June 30, 2024.

Speaker Change: and a net loss of $8.5 million, or $0.54 per share, for the six months ended June 30, 2024, compared to a net loss of $6.3 million, or $0.53 per share, all for the reasons previously mentioned.

Speaker Change: The company had 15,996,168 shares outstanding as of June 30, 2024.

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

David Luci: With that, I'll turn the call back over to Dave. Thank you, Rob, and thanks to all of you for joining us today.

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

Dave Lucci: Thank you, Rob, and thanks to all of you for joining us today. I'll now turn the call over to Rob, our operator, to open the call for questions. Rob?

Rob: I'll now turn the call over to Rob, our operator, to open the call for questions.

Operator: Thank you, Rob, and thanks to all of you for joining us today. I'll now turn the call over to Rob, our operator, to open the call for questions. Rob?

Rob: Rob? Thank you.

Unknown Attendee: Well, now we can duck in the question and answer session. If you'd like to ask a question today, please press star one from your telephone keypad, and confirmation tone to indicate your line is in the question queue. You may press star two if you'd like to withdraw your question from the queue. From distance, using speaker equipment, it may be necessary to pick up your handset before pressing the star keys. One moment, please. We'll be pulled for questions. Thank you.

Operator: will now be conducting the question and answer session. If you'd like to ask a question today, please press star 1 on your telephone keypad, and a confirmation tone will indicate your line is in the question queue. You may press star two if you'd like to withdraw your question from the queue. For participants using speaker equipment, it may be necessary to pick up your handset before pressing the star key. One moment, please repeat for questions. Our first question today comes from the line of Jason McCarthy with Maximal Group. Please proceed with your questions.

Rob: Thank you. We will now be conducting the question and answer session.

Rob: If you'd like to ask a question today, please press star 1 from your telephone keypad, and a confirmation tone will indicate your line is in the question queue.

Rob: You may press star 2 if you would like to withdraw your question from the queue.

Rob: For participants using speaker equipment, it may be necessary to pick up your handset before pressing the star keys.

Rob: One moment please while we poll for questions. Thank you.

Jason Mccarthy: Our first question today comes from the line of Jason McCarthy with Maximum Group.

Rob: Our first question today comes from the line of Jason McCarthy with Maxim Group.

Jason Mccarthy: Please just use your questions. Hey David, good morning. Thank you for taking the question.

Unknown Attendee: and financial results.

Jason Mccarthy: Hey David, good morning, thank you for taking the questions. Have you got any information on what Phase 3 could look like in terms of its size and scope? And also, is the plan to try to seek a partnership and or grant funding for some non-dualutive capital to advance that program, or will the company look to fund that trial itself?

Operator: At this time, all participants are in 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 from your telephone keypad. Please note, this conference is being recorded.

Speaker Change: Please proceed with your questions.

David Luci: Have you provided any information on what the phase three could look like in terms of its size and scope, and also the plan to try to seek a partnership and or grant funding for some non-delutive capital to advance that program, or will the company look to fund that trial itself? Thank you for this question, Jason. Yes, so we've provided guidance on the phase three. There are two required Phase Three registration studies. They are going to be set up as international trials with 450 patients in an ITT population, a piece, and they would be one-to-one randomized to either our I-Bezza Polstadt or oral Vancomycin.

Jason Mccarthy: Hey, David. Good morning. Thank you for taking the question. Have you provided any information on what the Phase 3 could look like in terms of its size and scope? And also, is the plan to try to seek a partnership?

Operator: At this time, we'll now turn the conference over to Rob Chief Financial Officer. Rob, you may begin. Thank you, Rob.

Speaker Change: and or grant funding for some non-dilutive capital to advance that program or will the company look to fund that trial itself?

Dave Luci: Thank you for the question, Jason. Yes, so we provided guidance on phase three. There are two required phase three registration studies. They are going to be set up as international trials with 450 patients in an ITT population apiece, and they would be one-to-one randomized to either our ibezapolstat or oral vancomycin. So that's the structure of the trials.

Speaker Change: Thank you for the question, Jason.

Speaker Change: Yes, so we provided guidance on the Phase 3. There are two required Phase 3 registration studies.

Speaker Change: They are going to be set up as international trials with 450 patients in an ITT population apiece, and they would be one-to-one randomized to either our ibezapolstat or oral vancomycin.

David Luci: So that's the structure of the trials.

Dave Luci: What we're attempting to do is to raise money, as you say, non-dilutively to the extent possible to pay for all or as much of the phase three program as we can, and then backfill with whatever else we need with an equity offering only if it's needed. So, for example, if we were to get among the deals that we're attempting to lock in, if we were to get a royalty finance partner, that may be a big number and may pay for an entire phase three out of the two we need to do.

Speaker Change: Thank you. Bye.

David Luci: What we're attempting to do is to raise money, as you say, non-dilutively, to the extent possible, to pay for all or as much of the phase three program as we can, and then backfill with whatever else we need with an equity offering only if it's needed. So, for example, if we were to get among the deals that were attempting to lock in, if we were to get a royalty finance partner, that may be a big number and may pay for an entire phase three out of the two we need to do. We're also looking at territorial partnerships, including South America, Europe, Japan, and there are a couple that are considering the whole launch a lot of.

Speaker Change: So that's the structure of the trials. What we're attempting to do is to raise money, as you say, non-dilutively to the extent possible to pay for all or as much of the Phase 3 program as we can.

Speaker Change: and then backfill with whatever else we need with an equity offering only if it's needed.

Speaker Change: So, for example, if we were to get a, among the deals that we're attempting,

Rob Schallant: 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 2024, which is available on our website at AcurxFarma.com.

Speaker Change: to lock in if we were to get a royalty finance partner.

Speaker Change: You know, that may be a big number and may pay for, you know, an entire phase three out of the two we need to do.

Rob Schallant: Joining me today is Dave Luci, President and CEO, who will give a corporate update and outlook. After that, I'll provide some highlights to the financials from the quarter end of June 30th, 2024, and then turn the call back over to Dave for his closing remarks. As a reminder, during today's call, we'll be making certain forward looking statements.

Dave Luci: We're also looking at territorial partnerships, including South America, Europe, Japan, and there are a couple that we are considering kind of like the whole enchilada. In which case, of course, phase three would be conducted by whoever buys it. We're also planning to file for a couple of grants, not a lot of government grants or quasi-government grants, if you will, and you know, pardon me if I don't mention the names, I just want to maximize our competitive position on the grants that we're, that we're thinking of, but those aren't a lot of ways to raise money that don't have anything to do with that police and answering, Okay.

Rob Schallant: These forward looking statements 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 from those contained in the forward looking statements. Investors should consider these risks and other information described in our filings made with the Securities and Exchange Commission, including our quarterly report on Form 10Q, which we filed on Thursday, August 8, 2024. Your question not to place any undue reliance on these forward looking statements, and Acurx disclaims any obligation to update such statements at any time in the future.

Speaker Change: We're also looking at territorial partnerships, including South America, Europe , Japan, and there are a couple that are considering, you know, kind of like the whole enchilada.

Rob Schallant: This conference call contains time-sensitive information that's accurate only as of the date of this live broadcast today, August 9, 2024.

David Luci: In which case, of course, the Phase III would be conducted by whoever buys us.

Speaker Change: In which case, of course, the phase three would be conducted by whoever buys us.

David Luci: We're also planning to file for a couple of grants, non-delutive government grants or quasi-government grants, if you will, and pardon me if I don't mention the names. I just want to maximize our competitive position on the grants that we're thinking of. But those are all non-delutive ways to raise money that don't have anything to do with equity financing.

Speaker Change: We're also planning to file for a couple of grants, non-dilutive government grants or quasi-government grants.

Dave Luci: I'll now turn the call over to Dave. Dave? Thanks Rob.

Dave Luci: Good morning everyone and thanks for joining us to review our financial results for the second quarter of 2024. Also to hear some very exciting recent updates, then we'll be pleased to take any questions. First, I'll summarize some of our key activities for the second quarter, or in some cases shortly thereafter. In April, we completed a successful end of phase two meeting with the FDA, confirming phase three readiness for our metaphors that are lead in a biotic candidate to enter phase three clinical trials for the treatment of C-dipicycle infection.

Speaker Change: if you will. And, you know, pardon me if I don't mention the names.

Speaker Change: I just want to, you know, maximize our competitive position on the grants that we're thinking of. But those are all non-dilutive ways to raise money that don't have anything to do with equity financing.

Dave Luci: Agreement with FDA was reached on key elements to move forward with our international phase three clinical trial program. Agreement was also reached with FDA on a complete non-clinical and clinical development plan for filing of a new drug application or NDA for marketing approval. We've soon continued activities to advance a vesicles that into international phase three clinical trials for the treatment of C-dipicycle infection. In parallel, we're also preparing to submit requests for regulatory guidance to initiate clinical trials in the European Union, United Kingdom, Japan, and Canada.

David Luci: And a recent vintage, we're even looking, or we're going to start looking at some stuff that's a little bit more creative with these SPACs that, you know, I lost favor, but there are still a number of SPACs that are outstanding that may have an interest. So that's an interesting thing that we're going to start following. Okay.

Speaker Change: And a recent vintage, we're even looking or we're going to start.

Speaker Change: looking at some stuff that's a little bit more creative with these SPACs that you know have lost favor but there are still a number of SPACs that are outstanding that may have an interest so that's a new stream that we're going to start pulling.

Dave Luci: Also in April, we attended the European Society of Microbiology and Infectious Disease or Estimates Scientific. Dr. Kevin Garry provided an oral presentation of our Phase 2 data entitled, A Phase 2 Randomized Double Blind Study of Life as a Post that, compared with vancomycin for the treatment of C, difficile infection. Dr. Garry is Professor in Chair University of Houston College of Pharmacy and the Principal Investigator for Microbiology and Microbiome aspects of the Life as a Post at Clinical Trial Program and he's a scientific advisory board member for Acurx.

Jason Mccarthy: Are you also looking at the potential for new antibiotics? That's just generally, that's the state. There's a company in Interim Therapeutics. We actually happen to cover it, but they do have an ad comp in early September, and probably right around when you're presenting or one of your presentations on I does for a new antibiotic for UTI. I don't know if it's something you guys are watching or paying attention to because we could see the antibiotic space getting a little bit active. Any thoughts on that? In interim therapeutics, I'd have to check with our team to see if we've reached out to them.

Jason Mccarthy: Have a good day. Are you also looking at the potential for new antibiotics, that just generally the space as a company interim therapeutics? We actually happen to cover it, but they do have an ad comp in early September, and Bobby right around when you're presenting one of your presentations for a new antibiotic for UTI. I don't know if it's something you guys are watching or paying attention to because we could see the antibiotic phase getting a little bit active. Any thoughts on that?

Speaker Change: Okay.

Speaker Change: All right.

Speaker Change: Are you also looking at...

Speaker Change: The potential for new antibiotics, that's just generally that the space, as is accompanied interim therapeutics.

Speaker Change: We actually happen to cover it, but they do have an ad come in early September , probably right around when you're presenting one of your presentations on iGESA for a new antibiotic for UTIs.

Speaker Change: I don't know if it's something you guys are watching or paying attention to because we can see the antibiotics phase getting a little bit active. Any thoughts on that?

Dave Luci: The oral presentation includes additional analyses of clinical and microbiological data and is available on our website at acurxforma.com. The complete Phase 2 results are being prepared for submission to a prominent scientific journal for publication. Also in July, results from the Avezopols that Phase 2 Clinical Trial and Patients with C, difficile infection were presented at the 17 Biennial Congress of the Anural Society of the Americas by Karen Yubag, Farm D, Research Assistant Professor University of Houston College of Pharmacy and her Karen's oral presentation was entitled, Clinical Efficacy of Avezopols that in CDI, C, difficile infection results from Phase 2 trials.

Dave Luci: Interim Therapeutics, I'd have to check with our team to see if we've reached out to them. I don't think we have, but certainly, we'd be wide open to a conversation.

Speaker Change: Interim therapeutics, I'd have to check with our team to see if we've reached out to them. I don't think we have, but certainly we'd be wide open to a conversation.

David Luci: I don't think we have, but certainly we'd be wide open to a conversation. Yeah, I'm saying just in terms of that's fine, but just in terms of activity in the space, just getting busy, maybe an opportunity for academics to benefit tangentially.

Jason Mccarthy: Yeah, yeah, no, I'm saying just in terms of, that's fine, but just in terms of activity in the space, just getting busy, maybe an opportunity for Acurx to benefit tangentially. Just last question, what is the cost you think of both trials combined, the two?

Speaker Change: Yeah, yeah, no, I'm saying just in terms of, that's fine, but just in terms of activity in the space, just getting busy, maybe an opportunity for Acurx.

Unknown Attendee: Just last question.

Speaker Change: to benefit tangentially. Just last question. What is the cost, you think, of both trials combined, the two phase threes?

David Luci: What is the cost you think of both trials combined at the two phase three? So the two together, they should be 25 million a piece. So together, they should be 50 million.

Dave Luci: So the two together, they should be $25 million a piece, so together they should be $50 million. But we're in this advantageous position that, you know, when you think about dilution, we can run the trials consecutively instead of concurrently. And then with positive data from the first phase three, as that's released, theoretically, our share price should see a significant rise. And then we can raise money at much higher prices to do the second phase three.

Speaker Change: So the two together, they should be $25 million apiece. So together they should be $50 million. But we're in this advantageous position that, you know, when you think about dilution, we can run the trials consecutively instead of concurrently.

David Luci: But we're in this advantageous position that when you think about dilution, we can run the trials consecutively instead of concurrently. And then, with positive data from the first phase three, as that's released theoretically, our share price should see a significant rise. And then we can raise money at much higher prices to do the second phase three. And the reason that's available to us almost uniquely is because we have 10 years of commercial exclusivity from the point of FDA approval, with similar regulatory protection in Europe, the UK, in Japan, and Canada. So that would actually work for us.

Dave Luci: Also in July, very timely given our late-stage development progress, the United States Patent and Trade Mark Office or USPTO granted us a new patent for Avezopols that which specifically encompasses the treatment of C, difficile infection while reducing recurrence of infection and improving the health of the gut microbiome. This patent expires in June, 2042 and we think will provide an important downstream competitive advantage.

Speaker Change: And then with positive data from the first phase three, as that's released, theoretically our share price should see a significant rise.

Speaker Change: and then we can raise money at much higher prices to do the second phase 3. And the reason that's available to us almost uniquely is because we have 10 years of commercial exclusivity from the point of FDA approval with similar regulatory protection in Europe , the UK, and Japan.

Dave Luci: And the reason that's available to us almost uniquely is because we have 10 years of commercial exclusivity from the point of FDA approval with similar regulatory protection in Europe, the UK, Japan, and Canada. So that would actually work for us.

Dave Luci: And finally, some late-breaking news today. Following our successful end-of-finished 2 clinical meeting with the FDA, which confirmed our Phase 3 clinical trial readiness and according to FDA regulatory requirements, we submitted our request to FDA for a meeting to review our manufacturing processes and specifications for drug substance and final product and packaging. Typically referred to as CMC or a chemistry manufacturing patrols for our Phase 3 clinical trials. We anticipate FDA to grant the meeting in the fourth quarter.

David Luci: And we also have this new patent going out to 2042, which is, if not unique, very unusual for an antibiotic to get a patent. An antibiotic. That patent covers what again, one more time. I mentioned it earlier. Yeah, the treatment of C. difficile infection and the reduction in reinfection and protection of the gut microbiome.

Dave Luci: And we also have this new patent going out to 2042, which is, if not unique, very unusual for an antibiotic to get a patent on an antibiotic. I'm sorry, that patent covers what again? I see you mentioned it earlier.

Speaker Change: and Canada. So that would actually work for us and we also have this new patent going out to 2042 which is, if not unique, very unusual for an antibiotic to get a patent on an antibiotic.

Dave Luci: Yeah, the treatment of C. difficile infection and the reduction and reinfection and protection of the gut microbiome. But, you know, Jason, I'd like to address something that you mentioned at the end of your first question, about antibiotics picking up some steam. It's true.

Speaker Change: One more time, I missed, I see you mentioned it earlier.

Speaker Change: Yeah, the treatment of C. difficile infection and the reduction and reinfection and protection of the gut microbiome.

David Luci: But Jason, I'd like to address something that you mentioned at the end of your first question, you know, about antibiotics picking up some steam. It's true. Antibiotics are picking up steam. So we've seen a substantial uptake in cases of C. difficile. We think it's a result of what's happened with the COVID experience worldwide.

Speaker Change: But you know, Jason, I'd like to address something that you mentioned at the end of your first question.

Dave Luci: Antibiotics are picking up steam, so we've seen a substantial uptick in cases of C. difficile. We think it's a result of what happened with the COVID experience worldwide. And at the World Antimicrobial Resistance Conference in September in Philadelphia, where we'll be presenting, we expect even more scientific push for the government to pass regulations like the Pasteur Act, which would have a tremendous benefit at getting new classes of antibiotics to the market because of the need.

Dave Luci: So now we have further momentum as we continue to seek one or more strategic transactions for the further development and potential commercialization of our median and biotic candidate at Avezopols that territory or globally in parallel with ongoing preparation for Phase 3 clinical trials.

Jason: you know, about, you know, antibiotics picking up some steam. It's true. Antibiotics are picking up steam.

Jason: So, we've seen a substantial uptick in cases of C. difficile.

Jason: We think it's a result of

Jason: what's happened with with the COVID experience worldwide. And at the World Antimicrobial Resistance Conference in September in Philly...

David Luci: And at the world, the antimicrobial resistance conference in September and Philly, where we'll be presenting, you know, we expect even more scientific push for the government to pass regulations like the Pestura Act, which would have a tremendous benefit at getting new classes of antibiotics to the market because of the need. Now, I think what we have to do is find a way to satisfy that scientific need that's being announced at the antimicrobial resistance conference and other conferences throughout the world, like in blood, because antimicrobial resistance has become a real hot topic. There's a scientific need, but we've got to marry that up with, you know, the political tendencies not to want to do anything to benefit the farmer.

Dave Luci: We will provide a detailed update on our partnership transactions if and when we reach agreement with the third party. Throughout the rest of this year, we'll continue to roll out our Phase 2 results in either oral presentations or scientific posters, or in some cases both, which will include results from new analyses as data becomes available at various prominent scientific conferences, including the World Anticropial Resistance Conference in Philadelphia this also in September is the 8th International Seed Difficile Symposium in Bled Slovenia, which is the premier global venue for the review of Seed Difficile Research.

Jason: where we'll be presenting, you know, we expect even more scientific push for the government to pass regulations like the Pasteur Act.

Jason: which would have a tremendous benefit at getting new classes of antibiotics to the market because of the need.

Dave Luci: Now, I think what we have to do is find a way to satisfy that scientific need that's being enunciated at the Antimicrobial Resistance Conference and other conferences throughout the world, like BLED, because antimicrobial resistance has become a real hot topic. There's a scientific need, but we've got to marry that up with, you know, the political tendency is not to want to do anything to benefit big pharma. So I think the government and Congress need to find a way to satisfy scientific need without throwing a bone to the pharmaceutical community.

Jason: Now, I think what we have to do is find a way to satisfy that scientific need.

Jason: that's being enunciated at the Antimicrobial Resistance Conference and other conferences throughout the world like in BLED.

Jason: because antimicrobial resistance has become a real hot topic. There's a scientific need, but we've got to marry that up with...

Dave Luci: In October, we'll be presenting at the annual meeting of the Infentrum Disease Society in America or ID League in Los Angeles. As we continually report it, it does oppose that clinical results continued to outperform in a serious and potentially life threat in an infectious disease caused by a seed of a seal bacteria that the Center for Disease Control categorizes as an urgent threat and calls for new classes of antibiotics for initial treatment that also have a low incidence of recurrence.

Jason: You know, the political tendency is not to want to do anything to benefit big pharma. So I think the government and the Congress needs to find a way to satisfy the scientific need, you know, without throwing a bone to the pharmaceutical companies.

Jason Mccarthy: So I think the government and the Congress needs to find a way to satisfy the scientific need, you know, without throwing a bone to the farmer's suitable. Japanese. Got it. Interesting. Good stuff, David. Thank you. Thanks, Jason.

Jason Mccarthy: Got it. Interesting. Good stuff, David. Thank you.

Jason: Got it. Interesting. Good stuff, David. Thank you.

Ed Arce: Our next question is from the line of Ed Arce with AC Wayne, right? Pleas to see with your questions.

Operator: Our next question is from the line of Ed Arce, with H.C. Wainwright. Please excuse your question.

Jason: Thanks, Jason.

Speaker Change: Our next question is from the line of Ed Arce with H.C. Wainwright. Pleased to see you with your questions.

Dave Luci: A vesicles that also has FDA fast-track designation for treatment of seed of a seal infection. Additionally, we believe a vesicles that, if approved, could make a favorable impact by reducing the cost burden of recurrence-y difficile infection on our U.S, healthcare system, which is estimated at $4.7 billion annually.

Thomas Yip: Hi, good morning, everyone. This is Thomas Yip asking a couple of questions for us. I appreciate the kind of questions. Thank you. So, so, hi, good morning. And so, so first question from us, regarding the face to study in the U.S., you mentioned CNC review or the schedule for the FDA in fourth quarter. So, just trying to front figure out when should we expect the trial to start, specifically the first patient dosing? With that, the fourth quarter events? From where we are today, I think it would be naive of me to be that aggressive. I think we'd be lucky with the CNC being cleared in the fourth quarter.

Thomas Yip: Hi, good morning, everyone. This is Thomas Yip asking a couple of questions for us. I appreciate the kind of questions. Thank you. So, so, so, hi, good morning, and so first question from us: regarding the phase three study in the US, you mentioned CNC review the schedule for the FDA in the fourth quarter. So, just trying to try to figure out when to expect the trial to start, specifically the first patient dosing with those fourth quarter events.

Speaker Change: Hi, good morning everyone. This is Thomas Yip asking Acurx Pharmaceuticals a couple of questions for Ed. I appreciate the kind of questions.

Thomas Yip: Thank you. Hi, good morning. So first question from us regarding phase 3 study in the U.S., you mentioned CMT.

Dave Luci: We do believe the best is yet to come.

Speaker Change: review the schedule for the FDA in fourth quarter. So we're just trying to figure out when should we expect the trial to start, specifically the first patient dosing. Would that be fourth quarter events?

Rob Schallant: And now back to our CFO, Rob Schallant, to guide you through the highlights of our financial results for the second quarter of 2024. Rob? Thanks, Dave. Our financial results for the second quarter and the June 30th were included in our press release issued earlier this morning. The company ended the quarter with cash totaling $6.4 million, compared to $7.5 million as of December 31, 2023. During the second quarter, the company sold an additional 133,066 shares under its ATM financing program, with gross proceeds of approximately $0.3 million.

Dave Luci: From where we are today, I think it would be naive of me to be that aggressive. You know, I think we'd be lucky with the CMC being cleared in the fourth quarter. I think we'd be lucky to start in the first quarter of next year at the earliest. You know, I would, I would kind of calibrate myself in that direction. And keep in mind, you know, before we enroll, these are international studies, right?

Speaker Change: From where we are today, I think it would be naive of me to be that aggressive.

Speaker Change: You know, I think we'd be lucky with the CMC being cleared in the fourth quarter. I think we'd be lucky to start in the first quarter of next year at the earliest.

David Luci: I think we'd be lucky to start in the first quarter of next year at the earliest. I would kind of calibrate myself in that direction. And keep in mind, before we enroll, these are international studies, right? So, we want to get. We've talked about the international kind of areas where we want to seek regulatory guidance. We want to make sure that we meet at least with the European Medicines Agency before we start enrolling patients in their territory. So, we can't submit a regulatory package to the European Medicines Agency until we conclude the CMC review by FDA.

Speaker Change: You know, I would kind of calibrate myself in that direction. And keep in mind, you know, before we enroll, these are international studies, right? So, we want to get, I mean, we've talked about the international

Dave Luci: So we want to get, I mean, we've talked about the international areas where we want to seek regulatory guidance; we want to make sure that we meet at least with the European Medicines Agency before we start enrolling patients in their territory. So we can't submit a regulatory package to the European Medicine Agency until we conclude the CMC review by FDA because once that's done with FDA, then we can complete the process we've already started, which is the European Medicine Agency's submission. It needs to include all of the CMC stuff and the FDA's position, and then we can submit it to Europe, which we would hope to do probably in November or December of this year.

Rob Schallant: Research and development expenses for a three-month ended June 30th, 2024 were $1.8 million compared to $1.7 million for a three-month ended June 30th, 2023. The increase was due primarily to an increase in manufacturing related costs during the quarter of $0.4 million partially offset by a reduction in consulting fees of $0.3 million. For the six months ended June 30th, 2024, research and development expenses were $3.4 million compared to $2.8 million for the six months ended June 30th, 2023.

Speaker Change: kind of areas where we want to seek regulatory guidance, we want to make sure that we meet at least with the European Medicines Agency before we start enrolling patients in their territory.

Speaker Change: So we can't submit a regulatory package to the European Medicines Agency until we conclude the CMC review by FDA.

David Luci: Because once that's done with the FDA, then we can complete the process we've already started, which is the European Medicines Agency submission. It needs to include all of the CMC stuff and the FDA's position.

Speaker Change: Because once that's done with FDA, then we can complete the process we've already started, which is the European Medicines Agency submission.

Rob Schallant: An increase of $0.6 million primarily due to $0.8 million increase in manufacturing related costs offset by $0.2 million decrease in consulting related fees. General administrative expenses for a three-month ended June 30th, 2024 were $2.3 million compared to $1.7 million for a three-month ended June 30th, 2023. An increase of $0.6 million. The increase was primarily due to $0.3 million increased in professional fees and a $0.2 million increased in non-cash share-based compensation related costs.

Speaker Change: It needs to include all of the CMC stuff and the FDA's position, and then we can submit it in Europe , which we would hope to do probably in November or December of this year.

Thomas Yip: And then we can submit it in Europe, which we would hope to do in probably in November or December of this year. Right, thank you for the additional color.

Thomas Yip: Right, got it. Thanks. And then you touched on it earlier in the prepared remarks regarding Punisher Discussions. I was just wondering what form of Punisher we consider to be the ideal situation for Black Erick.

Speaker Change: to

Speaker Change: [inaudible]

Speaker Change: Right, got it. Thank you for the additional color. And then you touched on it earlier in the prepared remarks regarding partnership discussions. Just wondering what form of partnership would you consider to be the ideal situation for Acurx?

David Luci: And then you touched on it earlier in the prepared remarks regarding financial discussions. Just wondering what form of partnership we consider to be the ideal situation for graduates. Okay. Well, so, so our priority is to raise enough funding to keep I bezipulse that our role into and through phase three to get it to market as quickly as possible. So, so that's that's our top priority. Now, if that means behind that, you know, we would take the lead of whoever we're talking to as their preference. That could be say a European license and code of element agreement.

Dave Luci: Well, so our priority is to raise enough funding to keep iBeza Poolstat on a roll into and through phase three to get it to market as quickly as possible. So, that's our top priority. Now, if that means, behind that, you know, we would take the lead of whoever we're talking to as their preference.

Rob Schallant: For the six months ended June 30th, 2024, General administrative expenses were $5.1 million compared to $3.6 million for the six months ended June 30th, 2023, and Increase of $1.5 million. The increase was primarily due to a $1 million increase in professional fees, $0.4 million increase in non-cash share-based compensation costs, and a $0.1 million increase in legal costs. The company reported in that loss of $4.1 million, or $0.26 per diluted share for the 3 months ended June 30, 2024, compared to a net loss of $3.4 million or $0.28 per diluted share for the 3 months ended June 30, 2023.

Speaker Change: Well, so our priority is to raise enough funding to keep Ibiza Poolstat on a roll into and through Phase 3 to get it to market as quickly as possible.

Speaker Change: So, that's our top priority. Now, if that means, behind that, you know, we would take the lead of whoever we're talking to as their preference.

Dave Luci: That could be, say, a European license and co-development agreement. Or it could be a Japanese license and co-development agreement. The typical agreement would be an upfront payment, clinical and commercial milestones, and a royalty. However, we would probably try to remove the clinical and commercial milestones altogether and replace them with some degree of funding for the Phase III program. That fits our factual position most acutely, or it could be an M&A transaction. You know, South America is also a hot place right now.

Speaker Change: That could be, say, a European license and co-development agreement. It could be a Japanese license and co-development agreement.

David Luci: It could be a Japanese license and code of element agreement. You know, the typical agreement would be an upfront payment, miles, clinical and commercial milestones, in a royalty. We would probably try to remove the clinical and commercial milestones altogether and replace them with some degree of funding for the phase three program. Yeah, that fits our factual position most acutely. or it could be an M&A transaction. It's South America is also a hot place right now. We're getting some play from a couple of companies there, but that would be a smaller deal, and a royalty deal would also be a wonderful thing because those are quite chunky. So it could be 20 or 25 million dollars of non-deludive financing at the closing.

Speaker Change: You know, the typical agreement would be an upfront payment, clinical and commercial milestones and a royalty. We would probably try to remove the clinical and commercial milestones altogether.

Speaker Change: and replace them with some degree of funding for the Phase III program. That fits our factual position most acutely.

Rob Schallant: And a net loss of $8.5 million or $54 cents per share for the 6 months ended June 30, 2024, compared to a net loss of $6.3 million or $53 cents per share, all for the reasons previously mentioned. The company had $15 million, $996,168 shares outstanding as of June 30, 2024.

Speaker Change: Or it could be an M&A transaction, you know, South America is also a hot place right now. I mean, we're getting some some play from a couple of companies there.

Dave Luci: I mean, we're getting some play from a couple of companies there, but that would be a smaller deal. And a royalty deal would also be a wonderful thing because those are quite chunky. So, you know, that could be 20 or 25 million dollars of non-deludive financing at the closing. Unknown Attendee, Michael Okunewitch, David Luci, Robert Shawah, Robert DeLuccia, Acurr. So it'd be a percentage, you know, royalty on the back end, whether it's 10%, 15%, whatever the number is that our board agrees to.

Speaker Change: but that would be a smaller deal, and a royalty deal would also be a wonderful thing because those are quite chunky. So, you know, that could be $20 or $25 million of non-dilutive financing at the closing.

Dave Luci: With that, I'll turn the call back over to Dave. Thank you Rob, and thanks to all of you for joining us today.

Thomas Yip: And you give up for that, you know, a royalty based on the financial modeling that the royalty finance group does. So it'd be a percentage, you know, royalty on the back end, you know, whether it's 10%, 15%, whatever the number is, our board agrees to. All right, thanks for that.

Speaker Change: and you give up for that, you know, a royalty based on the financial modeling that the Royalty Finance Group does.

Operator: I'll now turn the call over to Rob, our operator, to open the call for questions. Rob? Thank you.

Speaker Change: So it'd be a percentage, you know, royalty on the back end.

Operator: Well now we can duck in the question and answer session. If you'd like to ask a question today, please press star one from your telephone keypad, and confirmation tone to indicate your line is in the question queue. You may press star two if you'd like to withdraw your question from the queue. From distance using speaker equipment, it may be necessary to pick up your handset before pressing the star keys. One moment please, we'll be pulled for questions. Thank you.

Speaker Change: You know, whether it's 10%, 15%, whatever the number is that our board agrees to.

Thomas Yip: All right, thanks for that. And then perhaps one last question from us, kind of following up on your thought: the priority is to start phase 3 ASAP. Would it be possible to start the phase 3 study at both U.S. and ex-U.S. sites? Would it be possible to start piecemeal, starting with U.S. sites first, you know, even with an ex-U.S. agreement in hand, such as with EMA? Would that be a possibility to roll out the phase 3 study? Yeah, I mean, we'd have to

Speaker Change: Thank you.

David Luci: And then perhaps one last question from us, kind of following up on your top priority is to start phase 3 ASAP. Where'd it be possible to start the phase 2 study, you know, both U.S. and mixed U.S. sites, where's the possibility to start a piecemeal, starting with U.S. sites first, you know, even with U.S. agreement in hand, such as with DNA. Would that be a possibility to roll out the phase 3 study? Yeah, I mean, we have to, we have to talk to our R&D team to make sure that we're not, you know, we're not kind of stepping on any toes in Europe if we were to do that or to make sure that we're not by doing that, we don't want to be a stock from some benefit in Europe that we could have gotten if we had it pre-agreed.

Dex: All right, Dex, thanks for that. And then perhaps one last question from us, kind of following.

Dex: on your thoughts. The priority is to start phase 3 ASAP. Would it be possible to start the phase 3 study

Jason Mccarthy: Our first question today comes from the line of Jason McCarthy with maximum group.

Dave Luci: Please just use your questions. Hey David, good morning. Thank you for taking the question. Have you provided any information on what the phase three could look like in terms of its size and scope, and also the plan to try to seek a partnership and or grant funding for some non-delutive capital to advance that program, or will the company look to fund that trial itself? Thank you for this question, Jason. Yes, so we've provided guidance on the phase three.

Speaker Change: both U.S. and mixed U.S. sites. What is the process to start piecemeal, starting with U.S. sites first, even with mixed U.S.?

Speaker Change: agreement in hand, such as with EMA, would that be a possibility to roll out the Phase 3 study?

Dave Luci: Yeah, I mean, we'd have to talk to our R&D team to make sure that we're not kind of stepping on any toes in Europe if we were to do that, or to make sure that, by doing that, we don't want to be stopped from some benefit in Europe that we could have gotten if we had it pre-agreed. So that is certainly something that we're interested in. If we had the financing to do one of the two phase threes today, I'd say we'd still be on target to start them at least piecemeal in the fourth quarter.

Speaker Change: Yeah, I mean we'd have to, we'd have to talk to our R&D team to make sure that we're not...

Speaker Change: You know, we're not, uh...

Speaker Change: kind of stepping on any toes in Europe if we were to do that or to make sure that we're not

Speaker Change: By doing that, we don't want to be stopped from some benefit in Europe that we could have gotten if we had it pre-agreed.

Dave Luci: There are two required phase three registration studies. They are going to be set up as international trials with 450 patients in an ITT population, a piece, and they would be one-to-one randomized to either our I-Bezza Polstadt or Oral Vancomycin. So that's the structure of the trials. What we're attempting to do is to raise money, as you say, non-delutively, to the extent possible, to pay for all or as much of the phase three program as we can, and then backfill with whatever else we need with an equity offering only if it's needed.

David Luci: So that is certainly something that we're interested in. If we had the financing to do one of the two phase 3s today, I'd say we'd still be on target to start at least piecemeal in the fourth quarter.

Speaker Change: So, that is certainly something that we're interested in. If we had the financing to do one of the two phase threes today, I'd say we'd still be on target to start at least piecemeal in the fourth quarter.

Thomas Yip: Thank you so much again for taking our questions and looking forward to our phase incoming months. Awesome.

Thomas Yip: Thank you. Thank you so much again for taking our questions. I'm looking forward to updates in the coming months.

Speaker Change: I missed it.

Speaker Change: Thank you so much again for taking our questions and looking forward to updates in coming months.

Dave Luci: Awesome. Well, thank you for your questions and participation.

Unknown Attendee: Well, thank you for your questions and participation.

Speaker Change: Awesome. Well, thank you for your questions and participation.

James Molloy: Our next question is from the line of James Malloy with Alliance Global Partners. Please continue taking my questions this morning. I want to follow up a little more on Jason's question about partnerships. Sounds like you're speaking a little more on this call; perhaps you have, or maybe my faulty memory, about outright acquisitions. Can you walk a little bit through how that environment may have, may have changed over the quarter or how things may be looking? I know it's been a challenging space for biotech over the last year or so, but what do you see? And for just levels, are you able to disclose sort of a number of people you may be talking to or a relative size of the company you're talking to?

Operator: Our next question is from the line of James Molloy with Alliance Global Partners. Please proceed with your questions.

Speaker Change: Our next question is from the line of James Molloy with Alliance Global Partners. Please proceed with your question.

James Molloy: Good morning, David. Thank you. Good morning, David. Good morning, Rob.

James Molloy: Thank you for taking my questions this morning. I want to follow up a little more on Jason's question about partnerships. It sounds like you're speaking a little more on this call, perhaps than you have in the past, or maybe it's my faulty memory, about outright acquisitions. Can you walk a little bit through how that environment may have changed over the quarter or how things may be looking? I know it's been a challenging space for biotech over the last year or so, but what do you see in terms of purchase levels? Are you able to disclose the number of people you may be talking to or the relative sizes of the companies you're talking to?

James Molloy: Good morning, James. Good morning, David. Thank you. Good morning, David. Good morning, Rob. Thank you for taking my questions this morning.

Dave Luci: So for example, if we were to get among the deals that were attempting to lock in, if we were to get a royalty finance partner, that may be a big number and may pay for an entire phase three out of the two we need to do. We're also looking at territorial partnerships, including South America, Europe, Japan, and there are a couple that are considering the whole launch a lot of, in which case, of course, the Phase III would be conducted by whoever buys us.

James Molloy: I want to follow up a little more on Jason's question about partnerships.

James Molloy: It sounds like you're speaking a little more on this call, perhaps you have, or maybe it's my faulty memory, about outright acquisitions. Can you walk a little bit through how that environment may have may have changed over the quarter or how things may be looking? I know it's been a challenging space for biotech.

Speaker Change: of the last year or so. But what are you seeing for these levels? Are you able to disclose, sort of, a number of people you may be talking to or relative sizes of the companies you're talking to?

Dave Luci: Yeah, you know, the companies that we're talking to range in size, but they're all substantially larger than we are, and some of them are household names that we'd all recognize if we opened our medicine cabinet. So it's a great range, and you didn't miss anything, James.

David Luci: Yeah, you know, so the companies that we're talking to, they range in size, but they're all substantially larger than we are. And some of them are household names that we don't recognize if we open our medicine cabinet. So it's a great range. And you didn't miss anything, James. We started this process in earnest in the middle of May, around the time of our last earnings call. And I announced on that call that we were formally starting that the process. Because at that point in time, we had, well, we considered all the appropriate pieces having done our end of phase two meeting with the FDA and, you know, really having some good stuff, the risk stuff to talk about.

Speaker Change: Yeah, you know, so the companies that we're talking to, they range in size, but they're all substantially larger than we are, and some of them are household names that we'd all recognize if we open our medicine cabinet.

Dave Luci: We're also planning to file for a couple of grants, non-delutive government grants or quasi-government grants, if you will, and pardon me if I don't mention the names. I just want to maximize our competitive position on the grants that we're thinking of. But those are all non-delutive ways to raise money that don't have anything to do with equity financing. And a recent vintage, we're even looking, or we're going to start looking at some stuff that's a little bit more creative with these SPACs that, you know, I lost favor, but there are still a number of SPACs that are outstanding that may have an interest. So that's an interesting thing that we're going to start following.

Speaker Change: So, it's a great range, and you didn't miss anything, James. We started this process in earnest in the middle of May, around the time of our last earnings call, and I announced on that call that we were formally starting the process.

Dave Luci: We started this process in earnest in the middle of May, around the time of our last earnings call, and I announced on that call that we were formally starting the process. Because at that point in time, we had what we considered all the appropriate pieces, having done our end of phase two meeting with the FDA, and really having some good stuff, de-risked stuff to talk about. So at the time, it was perfect because, in late May, I signed up for the BioCEO Conference and got an unbelievable audience of potential interested parties around the country.

Speaker Change: because at that point in time we had what we considered all the appropriate pieces having done our end of phase two meeting with the FDA.

Speaker Change: and, you know, really having some good stuff, de-risked stuff to talk about.

David Luci: So the timing was perfect. Because in late May, you know, I signed up for the BioCEO conference and got an unbelievable audience of potential interested parties around the country. And, you know, I had, I think, 29 meetings out in San Diego. And we've hired a household name consultant that works on M&A and the business side. And they've reached out to dozens more on our behalf. We have a number of confidentiality agreements signed. You know, north of 5, maybe less than 12. But it's a lot more than I anticipated.

Speaker Change: So the timing was perfect because in late May, you know, I signed up for the BioCEO conference and

Speaker Change: got an unbelievable audience of potential interested parties.

Dave Luci: I had, I think, 29 meetings out in San Diego, and we've hired a household name consultant that works on M&A on the business side, and they've reached out to dozens more on our behalf. We have a number of confidentiality agreements signed. Title Microsoft Office Word Document MSWordDoc Word.

Speaker Change: around the country. And, you know, I had, I think, 29 meetings out in San Diego.

Jason Mccarthy: Okay. Are you also looking at the potential for new antibiotic? That's just generally that's the state. There's a company in interim therapeutics. We actually happen to cover it, but they do have a ad comp in early September, and probably right around when you're presenting or one of your presentations on I does for a new antibiotic for UTI. I don't know if it's something you guys are watching or paying attention to because we could see the antibiotic space getting a little bit active.

Speaker Change: and we've hired a household name.

Speaker Change: Consultant that works on M&A on the business side and they've reached out to dozens more On our behalf. We have a number of confidentiality agreements signed you know

Jason Mccarthy: Any thoughts on that? In interim therapeutics, I'd have to check with our team to see if we've reached out to them. I don't think we have, but certainly we'd be wide open to a conversation. Yeah, I'm saying just in terms of that's fine, but just in terms of activity in the space, just getting busy, maybe an opportunity for academics to benefit tangentially.

Dave Luci: Document.8, north of five, maybe less than 12, but it's a lot more than I anticipated. Now, you know, clothes only, a couch, horseshoes, and hand grenades, right, James? So, you know, we have to, you know, we have to close something out, and it's not done until it's done. But there's been a lot of interest, and as we're talking about with Jason, the interest is more than I anticipated it would be in the antibiotic space. And I think there are scientific reasons for that. You see, Listeria and some of these other things, along with C. diff peaking.

Speaker Change: north of five, maybe less than 12.

Speaker Change: But it's a lot more than I anticipated.

David Luci: Now, you know, close only counts in horseshoes and hand grenades, right, James? So, you know, we have to, you know, we have to close something out, and it's not done until it's done. But there's not a lot of interest, and as we're talking about with Jason, the interest is more than I anticipated it would be in the antibiotic space. And I think there are scientific reasons for that. You see Listeria and some of these other things along with sea depth peaking. And I, you know, I think there's also an element of social responsibility because the regulatory bodies, CDC, WHO, they're saying more and more publicly about the need for new classes of antibiotics and about the problem of antimicrobial resistance.

Speaker Change: Now, you know...

Speaker Change: Clothes only, couch and horseshoes and hand grenades, right James?

Speaker Change: You know, we have to, you know, we have to close something out and it's not done until it's done. But there's been a lot of interest and as we're talking about with

Jason: with Jason. The interest is more than I anticipated it would be in the antibiotic space.

Speaker Change: And I think there are scientific reasons for that.

Dave Luci: And, you know, I think there's also an element of social responsibility because the regulatory bodies, CDC, WHO, are saying more and more publicly about the need for new classes of antibiotics and about the problem of antimicrobial resistance. So I don't know if that answers your questions. But, you know, as I mentioned to Ed Arce, we're leading in these discussions with, you know, we're looking for a way to keep Ibeza Polstat at the fastest pace as possible to get out to market.

Speaker Change: along with C. diff peaking.

Speaker Change: And, you know, I think there's also an element of social responsibility because the regulatory bodies, CDC, WHO, they're saying more and more publicly about the need for new classes of antibiotics.

Dave Luci: Just last question. What is the cost you think of both trials combined at the two phase three? So the two together, they should be 25 million a piece. So together, they should be 50 million. But we're in this advantageous position that when you think about dilution, we can run the trials consecutively instead of concurrently. And then with positive data from the first phase three, as that's released theoretically, our share price should see a significant rise.

Speaker Change: and about the problem of antimicrobial resistance.

David Luci: So I don't know if that answers your questions, but, you know, so, as I mentioned, to Edoarcy, you know, we're leading in these discussions with, you know, we're looking for a way to keep my bezipole stat, you know, as prompt-a-paces possible to get out to market. And we'd like to, you know, kind of do that as not dilutively as we can. And, you know, then we're an open book. We listen to what potential partners would like to do. So, you know, some folks like the World Wide Rights; some folks, you know, are not positioned that way.

Speaker Change: So, I don't know if that answers your questions, but, you know, so, as I mentioned to Ed Arce,

Speaker Change: you know, we're leading in these discussions with, you know, we're looking for a way to keep Ibeza Polstat, you know, on as prompt a pace as possible to get out to market.

Dave Luci: And we'd like to, you know, kind of do that as non-dilutively as we can. And, you know, then we're an open book. We listen to what potential partners would like to do. So, you know, some folks like worldwide rights. Some folks, you know, are not positioned that way. They don't have the infrastructure, say, in the U.S. So it would be more of a European or a territorial Japanese deal. South America seems to go hand in hand with Central America. So we're talking to the biggest and second biggest down there. So that's what we have going on. I don't know how I can't be more transparent than that without violating confidentiality.

Speaker Change: And we'd like to, you know, kind of do that as non-dilutively as we can. And, you know, then we're an open book. We listen to what potential partners would like to do.

Dave Luci: And then we can raise money at much higher prices to do the second phase three. And the reason that's available to us almost uniquely is because we have 10 years of commercial exclusivity from the point of FDA approval with similar regulatory protection in Europe, the UK, in Japan and Canada. So that would actually work for us. And we also have this new patent going out to 2042, which is, if not unique, very unusual for an antibiotic to get a patent.

Speaker Change: So, you know, some folks like the World Wide Rights. Some folks, you know, are not positioned that way. They don't have infrastructure, say, in the U.S.

James Molloy: They don't have infrastructure, say, in the U.S. So, they would be more of a European or a territorial Japanese deal. South America seems to go hand in hand with Central America. So, we're talking to the biggest and second biggest down there. So, that's what we have going on. I mean, I don't know how I can't be more transparent than that without violating confidentiality agreements. No, absolutely not. You know, as always, I always say, as much as you can. I appreciate it very much. And almost all the awesome counts and closest to the pin, as I recall.

Speaker Change: So they would be more of a European or a territorial Japanese deal.

Speaker Change: South America seems to go hand-in-hand with Central America.

Speaker Change: So we're talking to the biggest and second biggest down there.

Dave Luci: An antibiotic. That patent covers what again, one more time. I mentioned it earlier. Yeah, the treatment of C difficile infection and the reduction in reinfection and protection of the gut microbiome. But Jason, I'd like to address something that you mentioned at the end of your first question, you know, about antibiotics picking up some steam. It's true. Antibiotics are picking up steam. So we've seen a substantial uptake in cases of C difficile.

Speaker Change: So that's.

Speaker Change: That's what we have going on. I mean, I don't know how I can't be more transparent than that without violating confidentiality agreements.

James Molloy: No, absolutely not, as always. How are you doing? I'm always interested in the accruals, but on a different note, I know you guys, on the ATM. You have about 8 million views of the ATM out of the 17 total. What's the run rate with the current cash you guys have, or even utilizing the ATM? What does that get you as you negotiate with these potential partners or other non-dilutive funding methods?

Speaker Change: No, absolutely not, as always.

Speaker Change: Always Expo.

Speaker Change: say as much as you can. I appreciate it very much. Almost all also counts in closest to the pin as I recall. Quick question for Robert Shawah, following up on that. I'm always interested in the accruals, but on a different note I know you guys

Rob: But I know I have a question for Rob Schall. Followed up on that. You know, I'm always interested in the rules. But on a different note, I know you guys, on the ATM, you have about 8 million; you've used the ATM with the 17-tool. What's the kind of the run rate where the current cash you guys have, or even you do as an ATM? What did I get you to as you're, you know, negotiating with these potential partners or other non-diluted funding methods? Sure, you know. Yeah, go ahead, Dave. Just going to say, you know, with the ATM, you know, we probably have sufficient funds without any trials going on until like the middle of 26.

Dave Luci: We think it's a result of what's happened with the COVID experience worldwide. And at the world, the antimicrobial resistance conference in September and Philly, where we'll be presenting, you know, we expect even more scientific push for the government to pass regulations like the Pestura Act, which would have a tremendous benefit at getting new classes of antibiotics to the market, because of the need. Now, I think what we have to do is find a way to satisfy that scientific need that's being announced at the antimicrobial resistance conference and other conferences throughout the world like in blood, because antimicrobial resistance has become a real hot topic.

Speaker Change: And on the ATM, you have about 8 million users of the ATM, of the 17 total. What's kind of the run rate with the current cash you guys have, or even utilizing the ATM? What does that get you to as you're, you know, negotiating with these potential partners or other non-dilutive funding methods?

James Molloy: Sure Jim, yeah, go ahead Dave.

Dave Luci: I was just going to say, you know, with the ATM, we probably have sufficient funds without any trials going on until like the middle of 26. Without the ATM, it's probably the middle of 25.

Speaker Change: I was just going to say, you know, with the ATM, you know, we probably have sufficient funds without any trials going on until like the middle of 26.

Rob: Without the ATM, it's probably the middle of 25. Excellent. That's all my questions. Thank you, gentlemen.

Speaker Change: Without the ATM, it's probably the

James Molloy: Excellent. That's all my questions. Thank you, gentlemen.

Speaker Change: Excellent. That's all my questions. Thank you, gentlemen.

Jonathan Colbert: The next question to no line of Jonathan Colbert with Biopop. Please proceed with Good morning, Jonathan. Good morning, Sir. Kind of following up on the ACN question. How many shares are still outstanding on that? And then secondly, are there any warrants still outstanding from previous financing? Oh, sure. Yeah, there's the way an ATM is set up. There's no share number associated with it. You know, we can pull down cash off the ATM at an intraday price on any given day. And it just, you know, the question of how many shares are granted is just the math of what the share price is and how much we sold.

Operator: The next question is from the line of Jonathan Colburn with BioPub. Please proceed with your questions.

Speaker Change: The next question is from the line of Jonathan Colburn with BioPub. Please proceed with your questions.

Jonathan Colburn: Hey David, how are you this morning?

Dave Luci: There's a scientific need, but we've got to marry that up with, you know, the political tendencies not to want to do anything to benefit the farmer. So I think the government and the Congress needs to find a way to satisfy the scientific need, you know, without throwing a bone to the farmer's suitable. Japanese.

Dave Luci: Good morning, Jonathan.

Jonathan Colburn: Good morning, sir. Kind of following up on the ACM question, how many shares are still outstanding on that? And then, secondly, are there any warrants still outstanding from previous financing?

Jonathan Colburn: Hey, David. How are you this morning?

David: Good morning, Jonathan.

Jonathan Colburn: Good morning sir. Kind of following up on the ATM question, how many shares are still outstanding on that? And then secondly, are there any warrants still outstanding from previous financing?

Jonathan Colburn: Oh, sure. Yeah, the way an ATM is set up, there's no share number associated with it. You know, we can pull cash out of the ATM at an intraday price on any given day. And it just, you know, the question of how many shares are granted is just the math of what the share price is and how much we sold. So there isn't like a fixed number, you know, where we're where we're limited. And your next question, I'm sorry, what was your second question?

Speaker Change: Oh, sure. Yeah, there's, uh, the way an ATM is set up, there's no share number.

Jason Mccarthy: Got it. Interesting. Good stuff, David. Thank you. Thanks, Jason.

Speaker Change: associated with it.

Speaker Change: You know, we can pull down cash off the ATM at an intraday price on any given day, and it just, you know, the question of how many shares are granted is just the math of what the share price is and how much we sold.

Ed Arce: Our next question is from the line of Ed Arce with AC Wayne, right? Pleas to see with your questions.

Dave Luci: Hi, good morning, everyone. This is Thomas Yip asking a couple of questions for us. I appreciate the kind of questions. Thank you. So, so, hi, good morning. And so, so first question from us, regarding the face to study in the U.S., you mentioned CNC review or the schedule for the FDA in fourth quarter. So, just trying to front figure out when should we expect the trial to start specifically the first patient dosing?

Rob: So there isn't like a fixed number, you know, where we're limited. And your next question, I'm sorry, what's your second question? Are there any warrants still outstanding from previous financing? Oh, yeah. Rob, what's the warrant number? Is it about five and a half million? Yeah, there were, there were warrants outstanding from previous financing and, you know, from, you know, legacy warrants. The actual number is 6.1 million. 6.1 million warrants outstanding, weighted average exercise price of $3.28.

Speaker Change: So there isn't like a fixed number, you know, where we're where we're limited.

Speaker Change: And your next question, I'm sorry, what was your second question?

Jonathan Colburn: Are there any warrants still outstanding from previous... Oh, yeah.

Rob Bawa: Oh yeah, Rob, what's the warrant number? Is it about $5.5 million?

Speaker Change: Are there any warrants still outstanding from previous financing?

Speaker Change: Rob, what's the warrant number? Is it about $5.5 million?

Rob Bawa: Yeah, there are warrants outstanding from previous financings and, you know, from, you know, legacy warrants. The actual number is 6.1 million. 6.1 million warrants outstanding, weighted average exercise price of $3.28.

Dave Luci: With that, the fourth quarter events? From where we are today, I think it would be naive of me to be that aggressive. I think we'd be lucky with the CNC being cleared in the fourth quarter. I think we'd be lucky to start in the first quarter of next year at the earliest. I would kind of calibrate myself in that direction. And keep in mind, before we enroll, these are international studies, right?

Rob: There are warrants outstanding from previous financings and legacy warrants. The actual number is $6.1 million.

Rob: 6.1 million, warrants outstanding, weighted average exercise price of $3.28.

Jonathan Colbert: Thank you, Rob.

Jonathan Colburn: David, could you kind of walk through a bit of what this new microbiome patent is, kind of how it gives ibuprofen and Acurix such an advantage? Obviously, like you said, it's kind of a newfangled thing, if you will.

David Luci: David, if you could, could you kind of walk through a bit of what's this new microbiome patent? Kind of, how does that give? I'd be the whole set in a cure; such an advantage. Obviously, like you said, it's kind of a newfangled thing, if you will. Well, the first advantage is that, you know, we now have patent protection in the US, which we can export abroad that goes out to June 2042. So that's, you know, we can, we can have slow enrollment, you know, for a lot of years before, you know, kind of the commercial value is any question on this thing.

Speaker Change: Thank you, Rob.

David: David, if you could, could you kind of walk through a bit of what this new microbiome patents? Kind of how does that give IbizaPulseDat and Acurx such an advantage? Obviously, like you said, it's kind of a newfangled thing, if you will.

Dave Luci: Well, the first advantage is that, you know, we now have patent protection in the U.S. which we can export abroad that goes out to June 2042. So that's, you know.

Dave Luci: So, we want to get, we've talked about the international kind of areas where we want to seek regulatory guidance. We want to make sure that we meet at least with the European Medicine Agency before we start enrolling patients in their territory. So, we can't submit a regulatory package to the European Medicine Agency until we conclude the CMC review by FDA. Because once that's done with FDA, then we can complete the process we've already started, which is the European Medicine Agency submission.

David: Well, the first advantage is that, you know, we now have patent protection in the U.S. which we can export abroad that goes out to June 2042.

Dave Luci: We can have slow enrollment for a lot of years before the commercial value of this thing is any question. It's just a really long period of time. What's unusual about it is that most antibiotics cause dysbiosis, that is an imbalance in the healthy gut bacteria. And we now have validation from the USPTO that, in fact, R.I.P., as opposed to that, is able to kill. C. difficile bacteria and is able to reduce the likelihood of reinfection, that's part of the patent, and we're also restoring the healthy microbiome.

Speaker Change: So, that's...

Speaker Change: You know.

Speaker Change: We can have slow enrollment, you know, for a lot of years before, you know, kind of the commercial value is any question on this thing. It's just a really long period of time. What's unusual about it is most antibiotics cause dysbiosis.

David Luci: It's just a really long period of time. What's unusual about it is most antibiotics called dysbiosis. That's, you know, an imbalance in the healthy gut bacteria. And we know a validation from the US PTO that, in fact, all right, as opposed to that is able to kill, C. difficile bacteria and is able to reduce the likelihood of reinfection. That's part of the patent. And also, we're restoring the healthy microbiome. So anybody who's looking at antibiotics as, you know, not being a good thing because they cause dysbiosis generally will look at our antibiotic and say, well, you know, maybe we don't need to replace antibiotics with other stuff because of the dysbiosis it causes.

Speaker Change: That's an imbalance in the healthy gut bacteria. And we now have validation from the USPTO that in fact

Dave Luci: It needs to include all of the CMC stuff and the FDA's position. And then we can submit it in Europe, which we would hope to do in probably in November or December of this year. Right, thank you for the additional color. And then you touched on it earlier in the prepared remarks regarding financial discussions. Just wondering what form of partnership we consider to be the ideal situation for graduates. Okay. Well, so, so our priority is to raise enough funding to keep I bezipulse that our role into and through phase three to get it to market as quickly as possible.

Speaker Change: R.I.P. as opposed to that is able to kill.

Speaker Change: C. difficile bacteria, and is able to reduce the likelihood of reinfection, that's part of the patent, and also we're restoring the healthy microbiome.

Dave Luci: So anybody who's looking at antibiotics as, you know, not being a good thing because they cause dysbiosis, uh... generally, we'll look at our antibiotic and say well, you know maybe we don't need to replace antibiotics with other stuff because of the dysbiosis it causes maybe we just need to find antibiotics that don't cause dysbiosis and in fact help restore a healthy microbiome, So, in that regard, it's the only antibiotics patent of its kind that I know of.

Speaker Change: So, anybody who's looking at antibiotics as, you know, not being a good thing because they cause dysbiosis.

Dave Luci: So, so that's that's our top priority. Now, if that means behind that, you know, we would take the lead of whoever we're talking to as their preference. That could be say a European license and code of element agreement. It could be a Japanese license and code of element agreement. You know, the typical agreement would be an upfront payment miles clinical and commercial milestones in a royalty. We would probably try to remove the clinical and commercial milestones altogether and replace them with some degree of funding for the phase three program.

Speaker Change: generally, will look at our antibiotic and say, well, you know, maybe we don't need to replace antibiotics with other stuff because of the dysbiosis it causes.

David Luci: Maybe we just need to find antibiotics that don't cause dysbiosis. And in fact, help restore a healthy microbiome.

Speaker Change: Maybe we just need to find antibiotics that don't cause dysbiosis and, in fact, help restore a healthy microbiome.

David Luci: So, in that regard, it's the only antibiotics patent of its kind that I know. of Gotcha. Thank you. It's kind of codifying what we've already seen in pre-frontical and clinical data of the very, you know, the specificity as well as kind of the, you know, protective nature of how you supposed that. Yeah, and when you think about business development in, you know, within big pharma, you know, these big pharma companies tend to want to be cutting-edge science, and they tend to want their reputations to be tied to cutting-edge science, and this just helps make our case.

Speaker Change: So in that regard, it's the only antibiotics patent of its kind that I know of.

Jonathan Colburn: Gotcha. Thank you, kind of codifying what we've already, preclinical and clinical data, the very specificity as well as kind of the protective nature of abuse Yeah, and when you

Speaker Change: Gotcha, thank you. Kind of codifying what we've already seen.

Speaker Change: and pre-frontal and clinical data of the specificity as well as kind of...

Dave Luci: Yeah, and when you think about business development within big pharma, you know, these big pharma companies tend to want to be cutting-edge science, and they tend to want their reputations to be tied to cutting-edge science. And this just helps make our case. Gotcha. Thank you. No problem, Jonathan. Thank you.

Speaker Change: you know, protective nature of abuse post-death.

Speaker Change: Yeah, and when you think about business development in, you know, within big pharma, you know, these big pharma companies tend to want to be cutting edge science, and they tend to want their reputations to be tied to cutting edge science.

Dave Luci: Yeah, that fits our factual position most acutely, or it could be an M&A transaction. It's South America is also a hot place right now. We're getting some play from a couple of companies there, but that would be a smaller deal, and a royalty deal would also be a wonderful thing because those are quite chunky, so it could be 20 or 25 million dollars of non-deludive financing at the closing. And you give up for that, you know, a royalty based on the financial modeling that the royalty finance group does.

Jonathan Colbert: Gotcha. Thank you. No problem, Jonathan. Thank you.

Speaker Change: And this just helps make our case.

Speaker Change: Gotcha. Thank you.

Speaker Change: No problem Jonathan, thank you.

Operator: Thank you. At this time, there are no additional questions. I would like to thank everyone for joining us on our conference today. You may now disconnect your lines at this time, and we thank you for your participation.

Unknown Attendee: At this time, there are no additional questions. I would like to thank everyone for joining us on our conference today. You may now disconnect your lines this time, and we thank you for your participation. Thank you, Ralph. Thank you.

Speaker Change: Thank you. At this time, there are no additional questions. I'd like to thank everyone for joining us on our conference today. You may now disconnect your lines at this time, and we thank you for your participation.

Dave Luci: Thank you, Rob.

Rob: Thank you, Rob. Thank you.

Dave Luci: So it'd be a percentage, you know, royalty on the back end, you know, whether it's 10%, 15%, whatever the number is, our board agrees to. All right, thanks for that. And then perhaps one last question from us, kind of following up on your top priority is to start phase 3 ASAP. Where'd it be possible to start the phase 2 study, you know, both U.S, and mixed U.S, sites, where's the possibility to start a piecemeal, starting with U.S, sites first, you know, even with U.S, agreement in hand, such as with DNA.

Dave Luci: Would that be a possibility to roll out the phase 3 study? Yeah, I mean, we have to, we have to talk to our R&D team to make sure that we're not, you know, we're not kind of stepping on any toes in Europe if we were to do that or to make sure that we're not by doing that, we don't want to be a stock from some benefit in Europe that we could have gotten if we had it pre-agreed.

Dave Luci: So that is certainly something that we're interested in. If we had the financing to do one of the two phase 3s today, I'd say we'd still be on target to start at least piecemeal in the fourth quarter.

Ed Arce: Thank you so much again for taking our questions and looking forward to our phase incoming months. Awesome.

Unknown Attendee: Well, thank you for your questions and participation.

James Molloy: Our next question is from the line of James Malloy with Alliance Global Partners. Please continue taking my questions this morning. I want to follow up a little more on Jason's question about partnerships.

Dave Luci: Sounds like you're speaking a little more on this call perhaps you have, or maybe my faulty memory, about outright acquisitions. Can you walk a little bit through how that environment may have, may have changed over the quarter or how things may be looking? I know it's been a challenging space for biotech over the last year or so, but what do you see? And for just levels, are you able to disclose sort of a number of people you may be talking to or a relative size of the company you're talking to?

Dave Luci: Yeah, you know, so the companies that we're talking to, they range in size, but they're all substantially larger than we are. And some of them are household names that we don't recognize if we open our medicine cabinet. So it's a great range. And you didn't miss anything, James. We started this process in earnest in the middle of May around the time of our last earnings call. And I announced on that call that we were formally starting that the process.

Dave Luci: Because at that point in time, we had, well, we considered all the appropriate pieces having done our end of phase two meeting with the FDA and, you know, really having some good stuff, the risk stuff to talk about. So the timing was perfect. Because in late May, you know, I signed up for the BioCEO conference and got an unbelievable audience of potential interested parties around the country. And, you know, I had, I think, 29 meetings out in San Diego.

Dave Luci: And we've hired a household name consultant that works on M&A and the business side. And they've reached out to dozens more on our behalf. We have a number of confidentiality agreements signed. You know, North of 5, maybe less than 12. But it's a lot more than I anticipated. Now, you know, close only couch and horseshoes and hand grenades, right, James? So, you know, we have to, you know, we have to close something out and it's not done until it's done.

Dave Luci: But there's not a lot of interest, and as we're talking about with Jason, the interest is more than I anticipated, it would be in the antibiotic space. And I think there are scientific reasons for that. You see Listeria and some of these other things along with sea depth peaking. And I, you know, I think there's also an element of social responsibility because the regulatory bodies, CDC, WHO, they're saying more and more publicly about the need for new classes of antibiotics and about the problem of antimicrobial resistance.

Dave Luci: So I don't know if that answers your questions, but, you know, so, as I mentioned, to Edoarcy, you know, we're leading in these discussions with, you know, we're looking for a way to keep my bezipole stat, you know, as prompt-a-paces possible to get out to market. And we'd like to, you know, kind of do that as not dilutively as we can. And, you know, then we're an open book. We listen to what potential partners would like to do.

Dave Luci: So, you know, some folks like the World Wide Rights, some folks, you know, are not positioned that way. They don't have infrastructure, say, in the U.S. So, they would be more of a European or a territorial Japanese deal. South America seems to go hand and hand with Central America. So, we're talking to the biggest and second biggest down there. So, that's what we have going on. I mean, I don't know how I can't be more transparent than that without violating confidentiality agreements. No, absolutely not, you know, as always, I always say as much as you can. I appreciate it very much. And almost all the awesome counts and closest to the pin is I recall.

Rob Schallant: But I know I have a question for Rob Schall. Followed up on that. You know, I'm always interested in the rules. But on a different note, I know you guys, on the ATM, you have about 8 million, you've used the ATM with the 17-tool. What's the kind of the run rate where the current cash you guys have, or even you do as an ATM? What did I get you to as you're, you know, negotiating with these potential partners or other non-diluted funding methods?

Rob Schallant: Sure, you know. Yeah, go ahead, Dave. Just going to say, you know, with the ATM, you know, we probably have sufficient funds without any trials going on until like the middle of 26. Without the ATM, it's probably the middle of 25.

James Molloy: Excellent. That's all my questions.

Unknown Attendee: Thank you, gentlemen.

Jonathan Colbert: The next question to no line of Jonathan Colbert with Biopop. Please proceed with Good morning, Jonathan. Good morning, sir. Kind of following up on the ACN question. How many shares are still outstanding on that? And then secondly, are there any warrant still outstanding from previous financing? Oh, sure. Yeah, there's the way an ATM is set up. There's no share number associated with it. You know, we can pull down cash off the ATM at an intraday price on any given day.

Jonathan Colbert: And it just, you know, the question of how many shares are granted is just the math of what the share price is and how much we sold. So there isn't like a fixed number, you know, where we're limited. And your next question, I'm sorry, what's your second question? Are there any warrant still outstanding from previous financing? Oh, yeah. Rob, what's the warrant number? Is it about five and a half million? Yeah, there were, there were warrant outstanding from previous financing and, you know, from, you know, legacy warrants. The actual number is 6.1 million. 6.1 million warrant outstanding weighted average exercise price of $3.28.

Dave Luci: Thank you Rob. David, if you could, could you kind of walk through a bit of what's this new microbiome patent? Kind of, how does that give? I'd be the whole set in a cure such an advantage. Obviously, like you said, it's kind of a newfangled thing, if you will. Well, the first advantage is that, you know, we now have patent protection in the US, which we can export a broad that goes out to June 2042.

Dave Luci: So that's, you know, we can, we can have slow enrollment, you know, for a lot of years before, you know, kind of the commercial value is any question on this thing. It's just a really long period of time. What's unusual about it is most antibiotics called dysbiosis. That's, you know, an imbalance in the healthy gut bacteria. And we know a validation from the US PTO that in fact, all right, as opposed to that is able to kill, see difficile bacteria and is able to reduce the likelihood of reinfection.

Dave Luci: That's part of the patent. And also, we're restoring the healthy microbiome. So anybody who's looking at antibiotics as, you know, not being a good thing because they cause dysbiosis generally will look at our antibiotic and say, well, you know, maybe we don't need to replace antibiotics with other stuff because of the dysbiosis it causes. Maybe we just need to find antibiotics that don't cause dysbiosis. And in fact, help restore a healthy microbiome. So in that regard, it's the only antibiotics patent of its kind that I know, of Gotcha.

Jonathan Colbert: Thank you. It's kind of codifying what we've already seen in pre-frontical and clinical data of the very, you know, the specificity as well as kind of the, you know, protective nature of how you supposed that. Yeah, and when you think about business development in, you know, within big pharma, you know, these big pharma companies tend to want to be cutting-edge science, and they tend to want their reputations to be tied to cutting-edge science, and this just helps make our case. Gotcha. Thank you. No problem, Jonathan. Thank you.

Operator: At this time, there are no additional questions. I would like to thank everyone for joining us on our conference today. You may now disconnect your lines this time and we thank you for your participation. Thank you, Ralph. Thank you.