Acurx Pharmaceuticals Inc. Q1 2024 Earnings Call
Operator: Hello, and welcome to the Acurx Pharmaceuticals First Quarter 2024 Financial Results Conference Call. If anyone should require operator assistance, please press star zero on your telephone keypad. A question and answer session will follow the formal presentation. You may be placed into the question queue at any time by pressing star 1. As a reminder, this conference is being recorded. It's now my pleasure to turn the conference over to CFO Robert Shawah. Please go ahead.
Hello, and welcome to the accurate Pharmaceuticals first quarter 2024 financial results conference call and saying, what's it require operator assistance. Please press star zero on your telephone keypad.
A question and answer session will follow the formal presentation. He may be placed in the question queue at any time by pressing star one.
Speaker Change: As a reminder, this conference is being recorded its now my pleasure to turn the conference over to CFO Robert Shovlin. Please go ahead.
Robert G. Shawah: Thank you, Kevin. Good morning, and welcome to our call. This morning, we issued a press release providing financial results and company highlights for the first quarter of 2024, which is available on our website at www.acurxpharma.com. Joining me today is Dave Lucci, President and CEO of Acurx, who will give a corporate update in Outlook, as well as our Executive Chairman, Bob DeLucia. After that, I'll provide some highlights of the financials for the quarter ended March 31, 2024.
Robert G. Shawah: Thank you Kevin Good morning, and welcome to our call. This morning, we issued a press release, providing financial results and company highlights for the first quarter of 2024.
Robert G. Shawah: Then I turn the call back over to Dave and Bob for their closing remarks. 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 with the Securities and Exchange Commission, including our quarterly report on Form 10-Q, which we filed on Tuesday, May 14, 2021.
Robert G. Shawah: Which is available on our website at <unk> Dot com.
Robert G. Shawah: Joining me today is Dave Lucci, President and CEO of <unk>.
Robert G. Shawah: Who will give a corporate update and outlook.
Robert G. Shawah: As well as our executive Chairman, Bob dilute yet.
Robert G. Shawah: After that I'll provide some highlights of the financials from the quarter ended March 31 2024.
Speaker Change: Ill turn the call back over to Dave and Bob for their closing remarks.
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.
They are subject to change and involve a number of risks and uncertainties that may cause actual results.
Speaker Change: 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.
Including our quarterly report on Form 10-Q, which we filed on Tuesday may 14th 2024.
Speaker Change: Your question not to place undue reliance on these forward looking statements.
Speaker Change: And that corrects disclaims any obligation to update such statements at any time in the future.
Robert G. Shawah: Your question not to place undue reliance on these forward-looking statements, and Acurx disclaims any obligation to update these such statements at any time in the future. This conference call contains time-sensitive information that's accurate only as of the date of this live broadcast today, May 15th, 2015. I'll now turn the call over to Dave Lucci. Dave?
Speaker Change: This conference call contains time sensitive information that is accurate only as of the date of this live broadcast today May 15 2024.
Speaker Change: I'll now turn the call over to Dave Lucci, David.
David P. Luci: Thanks Rob. Good morning everyone and thanks for joining us to review our financial results for the first quarter and also to hear some exciting recent updates, then we'd be pleased to take any questions. First, I'll summarize some of our key activities for the first quarter of 2024, or in some cases shortly thereafter. In January, we announced Positive Comparative Microbiology and Microbiome Data, or Advesipolistat, our lead antibiotic candidate, and C. diff patients from the Phase IIb clinical trial set, as opposed to that outperformed vancomycin, a standard of care, showing eradication of fecal C. difficile at day three, of treatment in 15 of 16 treated patients, 94%, versus vaccomycin, which had eradication of C. difficile in 10 of 14 treated patients, or 71%.
David P. Luci: Thanks, Rob and good morning, everyone and thanks for joining us to review our financial results for the first quarter and also to hear some exciting recent updates.
David P. Luci: We'd be pleased to take any questions.
David P. Luci: Additional data from the Phase 2b clinical trial showed that mezopulstat, but not zycomycin, consistently preserved and allowed the regrowth of key gut bacteria species believed to confer health benefits, including preventing recurrent C. diff infections. Additional data from exploratory endpoints will provide further favorable separation between these two therapeutic options in our Phase 3 clinical trial program and ultimately in the marketplace. We remain particularly excited about the dual impact of Ibiza Polstat, to treat acute C. difficile on the one hand, while appropriately managing the long-term care of each patient's microbiome, which we believe is truly exceptional for antibiotic therapy, having robust preclinical, clinical, and manufacturing data to date.
Speaker Change: First I'll summarize some of our key activities for the first quarter of two O 24 or in some cases shortly thereafter.
Speaker Change: In January we announced positive comparative microbiology in microbiome data right I suppose that our lead antibiotic candidate and C. Diff patients from the phase <unk> clinical trial segment.
Speaker Change: And that's what pulls that outperformed vancomycin a standard of care.
Speaker Change: Showing eradication of sequel C difficile phase III.
Speaker Change: Oh of treatment in 15, or 16 treated patients, 94% versus vancomycin, which had eradication of C. Difficile and 10 out of 14 treated patients or 71%.
Speaker Change: Additional data from the same to be clinical trial show that as a full stack, but NASDAQ goodbyes, it consistently preserved and allowed regrows.
Speaker Change: Key gut bacteria species leads to confer health benefits, including.
Speaker Change: Preventing the recurrent C diff infection.
Speaker Change: Additional data from the exploratory end points will provide further favorable separation between these two therapeutic options in our phase III clinical trial program and ultimately in the marketplace if approvals.
Speaker Change: We remain particularly excited about the dual impact of my basketball step.
Speaker Change: To treat acute C difficile, one hands, while appropriately managing the long term care of each patient's microbiome, which we believe is truly exceptional for antibiotic therapy.
Speaker Change: Having a robust preclinical clinical and manufacturing data to date.
David P. Luci: We submitted a formable information package to the FDA in January, along with a request for an end of phase two meeting, which was granted on February 26th, and the meeting was convened on April 17th. At the FDA meeting, we reached agreement on key elements of our Phase III program, including, importantly, agreement with the FDA regarding readiness to proceed to Phase 3, as well as agreement on the regulatory pathway for a new drug application filing for marketing approval in the U.S. We will press release further details on the FDA meeting pre-market this morning.
Speaker Change: We submitted in January affordable information package.
Speaker Change: So the FDA along with our request for an end of Phase II meeting, which was granted on February 26, and the meeting was convened on April 17th.
Speaker Change: The FDA meeting we reached agreement on key elements of our phase III program.
Speaker Change: Including importantly agreement with the FDA regarding readiness to proceed to phase III.
As well as agreement on a regulatory pathway for a new drug application finally for marketing approval in the U S.
Speaker Change: We will press release further details on the FDA meeting pre market. This morning.
David P. Luci: In February, we announced that the European Medicines Agency approved our application to be designated as a small-to-medium-sized enterprise, or SME, in Europe, which provides for certain benefits, including fee reductions and other support from the agency for seeking a marketing authorization in Europe. We attended the European Society of Microbiology and Infectious Diseases, or ESMID.
Speaker Change: In February we announced that the European Medicines agency approved our application to be designated as a small to medium sized enterprises or SME in Europe, which provides for a certain benefits, including fee reductions and other support from the agency for seeking a marketing authorization in Europe.
Speaker Change: We attended the European Society of Microbiology, and infectious disease or estimates scientific Congress in April 2024.
David P. Luci: Scientific Congress in April 2024, where Dr. Kevin Gehry, Professor and Chair, University of Houston College of Pharmacy, and the Principal Investigator for Microbiology and Microbiome Aspects of our Clinical Trial Program, and our Scientific Advisory Board Member, provided an oral presentation of Phase 2 data entitled, A Phase 2 Randomized Double Blind Study of Ibesipolstat Compared with Vecomycin for the Treatment of C. difficile Infection. The presentation included additional analyses of clinical and microbiological data and is available on our website at www.acurxpharmaceuticals.com.
Speaker Change: Where Dr. Kevin Gary.
Speaker Change:
Speaker Change: Professor and chair of the University of Houston College of Pharmacy, and the principal investigator for microbiology in microbiome aspects of our clinical trial program.
Speaker Change: In our scientific Advisory Board member provided an oral presentation of phase III data entitled.
Speaker Change: A phase II randomized double blind study of a desert full staff compared with vancomycin for the treatment of C difficile infection.
Speaker Change: The presentation included additional analysis of clinical and microbiological data and is available on our website at www dot accurate pharmaceutical stocks up.
David P. Luci: The complete Phase II results are being prepared for submission to a prominent scientific journal for publication this year. 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 become available, at various prominent scientific conferences, including the Houston C. diff and Microbiome Conference later this month, the Anaerobic Society of America Annual Conference in July, and the World Antimicrobial Resistance Conference in September. Also in September is the International C-DIF Symposium and, of course, the annual meeting of the Infectious Disease Society of America or ID Week in October.
The complete phase II results are being prepared for submission to a prominent scientific journal for publication this year.
Speaker Change: Throughout the rest of this year, we will continue to rollout our phase II results in either oral presentation at a scientific posters or in some cases, both which will include results from new analyses as data become available at various prominent scientific conferences, including the Houston see different microbiome.
Speaker Change: Conference later this month, the Anaerobe Society of America Annual Conference in July the World Antimicrobial resistance conference in September.
Speaker Change: I also want to Denver is the international <unk> Symposium.
Speaker Change: And of course, the annual meeting of the infectious disease Society of America, or I D week in October.
David P. Luci: Throughout the first quarter, we continued preparations for Phase III trials, including advances in micro and manufacturing, CRO selection and clinical site screening, and building a team of international drug development experts to support our Phase III mandate. To ensure phase 3 clinical trial enrollment as quickly as possible, we're adding substantially more clinical trial sites, way above the number used to conduct the U.S.-only phase 2 trial. We're now finalizing costs and timelines, and our plan is to conduct the required two phase three registration trials consecutively, not concurrently, given the size of our company and the need to use our financial resources most efficiently.
Speaker Change: Throughout the first quarter, we continued preparations for phase III trials, including advances in micro and manufacturing.
Speaker Change: CRO selection and clinical site screening and building a team of international drug development experts to support our phase III mandate.
Speaker Change: To ensure phase III clinical trial enrollment as quickly as possible.
Speaker Change: Adding substantially more clinical trial sites.
Speaker Change: Way above the number you used to conduct the U S only phase II trials.
Speaker Change: We're now finalizing costs and timelines and our plan is to conduct the required two phase III registration trials.
Speaker Change: Secondly, not been thoroughly given the size of our company and easy to use our financial resources most efficiently.
David P. Luci: The timeline to conduct our Phase III trials is not a concern since our investment polls state we'll have a rolling 10 years of regulatory exclusivity in the U.S. for the date of FDA approval, with similar exclusivity available in Europe, the UK, Japan, and China. We will continue to seek a strategic transaction for the company, including a potential partnership for the further development and potential commercialization of Ibiza Polestat, alongside preparation for phase three in our build-out strategy. At this time, we have no commitments from potential partners or others to report.
Speaker Change: The timeline to conduct our phase III trials is not a concern since it doesn't close that we'll have a rolling 10 years of regulatory exclusivity in the U S from the date of the FDA approval.
Speaker Change: With similar exclusivity available in Europe, the UK, Japan and Canada.
Speaker Change: We will continue to seek a strategic transaction for the company, including a potential partnership.
Speaker Change: The further development and potential commercialization, although it is a full stack alongside preparation for phase III and our build out strategy.
Speaker Change: At this time, we have no commitments from potential partners or others to report.
David P. Luci: But now, having FDA confirmation of the registration plan, this has become an active initiative. As we've consistently reported, Adventa Polstat clinical results continue to outperform in a serious and potentially life-threatening infection. The CDC categorizes C. difficile as an urgent threat and calls for new classes of antibiotics for initial treatment that also have a low incidence of recurrence, and Desert Foreset is also FDA Fast-Track designated for the treatment of C. difficile. Initially, we believe Benzopilocet, if approved, could make a favorable impact by reducing the cost burden of recurrent C. diff infection on the U. We do believe the best is yet to come. And now, back to our CFO, Rob Shawah, to guide you through the highlights of our financial results for the first quarter.
Speaker Change: But now having FDA confirmation of the registration plan. This has become an active initiatives.
As we've consistently reported as opposed to add clinical results continue to outperform.
Speaker Change: Serious and potentially life threatening infection.
Uh huh.
Speaker Change: The CDC categorizes C difficile as an urgent threat it closer new classes of antibiotics for initial treatment.
Speaker Change: Also has a low incidence of recurrence.
Speaker Change: <unk> is also SBA SaaS track designated for the treatment of C difficile infection.
Speaker Change: Additionally, we believe <unk> if approved could make a favorable impact.
Speaker Change: Reducing the cost burden of recurrent C. Diff infection in the U S healthcare system, which is estimated at four $7 billion annually.
Speaker Change: We do believe the best is yet to come.
Speaker Change: And now back to our CFO Raj Shah will guide you through the highlights of our financial results for the first quarter.
Speaker Change: Rob.
David P. Luci: Thanks, Dave.
Robert G. Shawah: Our financial results for the first quarter ended March 31, 2024 were included in our press release issued earlier this morning. The company ended the quarter with cash totaling $8.9 million compared to $7.5 million as of December 31, 2023. During the first quarter, the company sold an additional 1,121,793 shares under its ATM financing program, with gross proceeds of approximately $4.4 million. Research and Development Expenses for the three months ended March 31, 2024 were $1.6 million compared to $1 million for the three months ended March 31, 2023.
Raj Shah: Our financial results for the first quarter ended March 31, 2024 were included in our press release issued earlier this morning.
Robert G. Shawah: The increase was due primarily to an increase in manufacturing-related costs during the quarter. General and Administrative Expenses for the 3 months ended March 31, 2024 were $2.8 million, compared to $1.9 million for the 3 months ended March 31, 2023. The increase was due primarily to a $0.7 million increase in professional fees and a $.2 million increase in non-cash share-based compensation. The company reported a net loss of $4.4 million, or $0.28 per diluted share, for the three months ended March 31, 2024, compared to a net loss of $2.9 million, or $0.25 per diluted share, for the three months ended March 31, 2021, for the reasons we previously mentioned The company had 15,757,102 shares outstanding as of March 31, 2021.
Rob: The company ended ended the quarter with cash totaling $8 $9 million.
Rob: Impaired to $7 5 million as of December 31, 2023.
Rob: During the first quarter the company sold an additional $1 million 121793 shares under its ATM financing program with gross proceeds of approximately $4 $4 million.
Rob: Research and development expenses for three months ended March 31 2024.
Rob: Were $1 $6 million compared to $1 million for the three months ended March 31 2023.
Rob: The increase was due primarily to an increase in manufacturing related costs during the quarter.
Rob: General and administrative expenses for the three months ended March 31 2024.
Rob: We're $2 $8 million.
Rob: Compared to $1 $9 million for the three months ended March 31 2023.
Rob: The increase was due primarily to a $7 million increase in professional fees.
Rob: And a point $2 million increase in noncash share based compensation.
Speaker Change: The company reported.
Speaker Change: Reported a net loss of $4 $4 million or 28 cents per diluted share for three months ended March 31 2024.
Speaker Change: Compared to a net loss of $2 $9 million or 25 cents per diluted share for the three months ended March 31 2023.
Speaker Change: Well for the reasons previously mentioned.
Speaker Change: The company had 15.757 million 102 shares outstanding as of March 31, 2000 22024.
David P. Luci: With that, I'll turn the call back over to Dave.
Speaker Change: With that I'll turn the call back over to Dave.
Speaker Change: Gabe.
David P. Luci: Thanks, Rob, and thanks to all of you for joining us today. I'll now ask Bob DeLuccia, our Executive Chairman, who managed the FDA post-Phase II meeting process, to provide his perspective on the FDA meeting and the company's Phase III mandate. Yeah, Dave.
Speaker Change: Thanks, Rob and thanks to all of you for joining us today.
Speaker Change: I will now.
As Bob <unk>, our executive Chairman, who manage the FDA post phase two meeting process to provide his perspective on the FDA meeting and the company's phase III mandate.
Speaker Change: Yes.
David P. Luci: Yeah. Thanks, Dave.
Robert J. DeLuccia: So let me just add a few thoughts on Papa Dave's comments about our end of phase two meeting with the FDA. In general, it was a very thorough, productive, and successful meeting regarding four things.
Speaker Change: So let me just add a few thoughts on top of Dave's comments.
Speaker Change: Comments about our end of phase two meeting with the FDA.
Robert J. DeLuccia: First, we reached overall agreement that was reached based upon the strength of our preclinical and phase two clinical trial results, including the anticipated safety database. We're ready to move forward with plans for our phase three program. Second, with respect to the Phase 3 clinical trial design, as expected, it'll be the same design as our Phase 2b trial, which is non-inferiority to vancomycin, with the primary endpoint being clinical cure after 10 days of treatment and a secondary endpoint of sustained clinical cure about 30 days after the end of treatment. Third, we agreed on the Statistical Analysis Patient Population, which will be a modified Intent to Treat, or what's called MITT, population with an estimated 450 subjects in that MITT group.
Bob: In general it was a very thorough productive and a successful meeting regarding four things first we had overall agreement that was reached based upon the strength of our preclinical and phase two clinical trial results, including the anticipated safety database, we're ready to move forward with plans for a phase.
Robert J. DeLuccia: And this is roughly what we had expected and will now be in sync with requirements for an EMA clinical trial authorization. And lastly, agreement on the registration program for two non-inferiority trials versus vancomycin, which would be required for marketing approval. Now I'd also add that we were very pleased with suggestions from the FDA, including final labeling and the overall supportive tone of the FDA from our submitted data to date and our plan going forward.
Speaker Change: III program.
Speaker Change: Second with respect to the phase III clinical trial design as expected it'll it'll be the same design as our phase two b trial, which is non inferiority to vancomycin with the primary endpoint being clinical cure after 10 days of treatment and the secondary endpoint of sustained clinical cure.
Speaker Change: About 30 days after the end of the treatment.
Speaker Change: Third we agreed on the statistical analysis patient population, which would be a modified intent to treat or what's called M. I T. T population with an estimated 450 subjects in that M. I T T group.
And this is roughly what we had expected and will now be in sync with requirements for any M. A clinical trial authorization.
Speaker Change: And lastly agreement on the registration program for two non inferiority trials versus vancomycin would you be required for marketing approval.
Speaker Change: And I'd also add that we were very pleased with suggestions from the FDA.
Speaker Change: Including ultimate labeling and overall supportive tone of the F. D. A from our submitted data to date and our plan going forward.
Robert J. DeLuccia: So, bottom line, we now have a complete regulatory roadmap to move forward with our phase three program, which is the last clinical development step toward marketing registration of iBizPulse globally. For a small entrepreneurial company like Acurx, this is a very significant milestone that we've reached. Dave, if you don't mind, I'd like to add one more thing, just on top of what you said.
Speaker Change: No.
Speaker Change: Bottom line, we now have a complete regulatory roadmap to move forward with our phase III program, which is the last clinical development step toward marketing registration of I suppose that globally.
Speaker Change: For a small entrepreneurial company like accurate. This is a very significant milestone that we've reached.
Speaker Change: And Dave if you don't mind I'd like to add one more thing just on top of what you said recall that I suppose that has FDA fast track designated status due to the urgent need classification by the U S. C. D C for new classes of antibiotics and there are similar classifications like this available in other geographies.
Robert J. DeLuccia: Recall that IbizaPulseNet has FDA fast-track designated status due to the urgent need classification by the U.S. CDC for new classes of antibiotics, and there are similar classifications like this available in other geographies, including Europe, the U.K., Japan, and Canada. If approved, IbizaPulseStat will be the first new class of antibiotics brought to the market in over three decades. So, we've got no time to waste to get this new product over the goal line.
Speaker Change: <unk>, Europe, and U K, Japan and Canada.
Speaker Change: If approved I bet, it's a pulse that will be the first new class of antibiotics brought to the market in over three decades. So we've got no time to waste to get this new product over the goal line.
Robert J. DeLuccia: And with the continued support of all our shareholders, we have a clear vision and a strong passion to be successful for the ultimate benefit of patients who need better treatments for C. difficile infection, and all our stakeholders, and, in general, for better public health.
Speaker Change: And with the continued support of all our shareholders, we have a clear vision and a strong passion to be successful for the ultimate benefit of patients who need better treatments for C difficile infection, and all our stakeholders and in general for better public health.
Speaker Change: Kevin.
Operator: Thank you. We'll now be conducting a question and answer session. If you'd like to be placed in the question queue, please press star 1 on your telephone keypad. A confirmation tone will indicate your line is in the question queue. You may press star two if you'd like to remove your question from the queue. One moment, please, while we poll for questions. Our first question today is coming from Ed Arce from H.C. Wayne. Write your line is now live.
Speaker Change: Thank you well now be conducting a question and answer session if you'd like to be placed in the question queue. Please press star one on your telephone keypad, a confirmation tone will indicate your line is in the question queue. You May press star two if he'd like to remove your question from the Q1 moment. Please while we eat.
Speaker Change: Hold for questions. Our first question today is coming from Ed Arce from H C. Wainwright. Your line is now live.
Antonio Eduardo Arce: Great, thanks for taking our questions, and Bob, I appreciate the comments at the end. Those were some of the questions I had regarding the specifics of the trial. A couple of follow-ups there.
Antonio Eduardo Arce: Great. Thanks for taking our questions and.
Bob: Bob I appreciate the comments at the end of those were some of the questions I had.
Bob: Regarding.
Antonio Eduardo Arce: The specifics around the trial a couple of follow ups there firstly.
David P. Luci: Firstly, the 450 patients or subjects that you mentioned, is that the total number for the trial? And also the usual requirement from the FDA of two well-designed pivotal studies. I want to just confirm that Phase IIb is being considered as one of those two, and so this upcoming trial would be the final study. Secondly, I wanted to ask about the costs and timelines. I know that you said that those are currently being finalized, but any preliminary or early commentary around those would be helpful for us.
Speaker Change: 450 patients or subjects that you mentioned is that the total number for the trial and also the.
Speaker Change: The usual requirement from the FDA or two.
Speaker Change: Well design.
Speaker Change:
Speaker Change: Pivotal studies.
Speaker Change: I wanted to just confirm that the phase to be is being considered as one of those two and so this upcoming trials would be the final study.
Speaker Change: Secondly, I wanted to ask about the cost and timelines I know that you said that those are currently being finalized.
Speaker Change: But.
Speaker Change: Any preliminary or early.
Speaker Change:
Speaker Change: Commentary around those would be helpful for us.
David P. Luci: And then lastly, around the strategic partners and your efforts now that you have a pathway for a pivotal study. I'm wondering, although you don't have any current commitments, do you have any active discussions at this point? Thanks so much.
Speaker Change: And then lastly.
Speaker Change: Round this the the strategic.
Speaker Change: Partners are in Europe.
Speaker Change: Our efforts now.
Speaker Change: You.
Speaker Change: Characterized as being active now that you have a pathway.
Speaker Change: For a pivotal study I'm wondering although you don't have any current commitments do you have any active discussions at this point.
Speaker Change: Thanks, so much.
David P. Luci: Thank you for your questions, Ed. With the last question being the easiest, I'll hit that one first.
Speaker Change: Well, thank you for your questions Ed.
Speaker Change: The last question being easier so I'll hit that one first.
David P. Luci: So, we have active discussions, several active discussions at the moment. Nothing to report, but, for example, the company will be well represented at the BIO CEO conference in San Diego, and my schedule is pretty full. So there's a lot of activity. We felt it was most appropriate before making outbound calls to have the FDA piece of the puzzle in place because we are now truly phase three ready, and that removes another piece of the puzzle in terms of things being set in stone. So that's all set.
Speaker Change: So.
Speaker Change: We have active discussions.
Speaker Change: Several active discussions at the moment nothing to report.
Speaker Change: But.
Speaker Change: For example, the company will be well represented at the bio CEO conference in San Diego.
Speaker Change: And nice schedule is Chuck full.
Speaker Change: So there's a lot of activity.
We felt it most appropriate.
Speaker Change: Before making outbound calls.
Speaker Change: Have the F D a piece to the puzzle in place.
Speaker Change: Because we now are truly phase III ready and that removes another piece of the puzzle in terms of things being said set in stone.
Speaker Change: So that's all set.
David P. Luci: On the first question with regard to the 450 MITT patients, that's the total number of MITT patients for each of the two Phase III registration trials. So, Phase 2B is not considered a registration trial. You may recall the small numbers of patients. And quite frankly, we needed a lot more patients to have a satisfactory safety database for an NDA application thereafter. So it's 450 patients, MITT, for each of the two trials, for a total of 900.
Speaker Change: And the first question with regard to the 450 <unk> patients. That's the total M. I T T patients for each of two phase III.
Speaker Change: Registration trials phase III registration trials. So the phase II B is not considered a registration trial you may recall that small numbers of patients and quite frankly, we needed a lot more patients to have.
Speaker Change: Satisfactory safety database.
Speaker Change: For an NDA application thereafter.
Speaker Change: So it's 450 patients.
Speaker Change: <unk>.
Speaker Change: For each of two trials for a total of 900.
Speaker Change: And.
David P. Luci: To answer your question, we are still going through the costings, so we don't know exactly how much it will cost. And, in some cases, if we have a partnership, it may be that some of the work that we would have paid for would be internalized by a fully integrated pharma company that will be side by side with us with a mutual interest to get the Phase III program done as quickly as possible and use our phase three data for filing So the MITT piece to the puzzle was a quick conversation with the FDA because, really, you need that to get approval in Europe and the UK.
Speaker Change: To your question, we are still going through the cost things. So we don't know exactly how much it will cost and in some cases, if we have a partnership.
Speaker Change: So it may be that some of the work that we would have paid for would be internalized by.
Speaker Change: Really integrated pharma company that will be side.
Speaker Change: Side by side with us with mutual interest to get the phase III program done as quickly as possible.
Speaker Change: And using our phase III data for filing.
Speaker Change: In Europe, the U K, Japan.
Speaker Change: So the <unk> piece of the puzzle was a quick conversation with the FDA had because really you need that to get to file for approval in Europe and the U K.
David P. Luci: So by agreeing on that particular point, we were able to avoid further clinical trials beyond phase two and phase three, and quite literally, we have an equal pathway in the U.S., the U.K., and Europe. So we're kind of delighted with that piece of the puzzle. But that's, I think that's, is there another piece to your question that I may have missed?
Speaker Change: By agreeing on that particular point, we were able to avoid further clinical trials beyond the two phase III.
Speaker Change: And quite literally we have a you know an equal pathway in the U S. The U K and Europe.
Speaker Change: So we're kind of delighted with that piece of the puzzle.
Speaker Change: But that's I think that's a cause.
Speaker Change: There's another piece to your question that I may have missed.
Speaker Change: Okay.
David P. Luci: Yeah, David, you had a question about the timeline. I mean, I can answer it if you'd like to.
David: Yeah, David a question on timeline I mean, I can answer it if you'd like to.
Speaker Change: Okay.
David P. Luci: Oh, the timeline. Yeah, we feel, based on what we've specced out so far, that it would be a year and a half to two years from first patient enrollment.
Speaker Change: Oh that timeline.
Speaker Change: Yeah.
Speaker Change: We feel based on what we expect out so far that would be a year and a half to two years.
Speaker Change: From first patient enrolled.
Speaker Change: Yeah.
Robert J. DeLuccia: And Ed, this is Bob. Just to reiterate, the two phase three trials are straightforward from the FDA guidelines, the October 22, I think it was, guidelines. And that's a very clear path for what's needed for approval.
And this is Bob just to reiterate to the two phase III trials in a straightforward from the FDA guidelines. The October 22, I think it was guidelines and that's that's a very clear path for what's needed for approval.
Speaker Change: And then N D a.
Antonio Eduardo Arce: Got it. Thank you so much. I appreciate it.
Speaker Change: Got it. Thank you so much I appreciate it.
Operator: Thank you. As a reminder, that's star number one to be placed in the question queue. Our next question is coming from Mike Lloyd, a private investor. Your line is now live.
Speaker Change: As a reminder, that star one to be placed in the question queue. Our next question is coming from Mike Baur into private Investor. Your line is now live.
James Francis Molloy: Good morning, gentlemen, and thank you for the update. It's very exciting. I can't wait to see the next steps. Quick question. An easy one, I hope. Has the company considered a priority review voucher?
Speaker Change: Good morning, gentlemen, and thank you for the update is very exciting.
Mike Baur: Wait to see the next steps I had quick question easy when I hope.
Speaker Change: Has the company considered a priority review voucher.
David P. Luci: for this application. Thank you.
Speaker Change: For this application thank you.
Robert J. DeLuccia: Thanks for the question, Mike. Bob, do you want to hit that one? Yeah, I mean...
Bob: Thanks for the question, Mike Bob do you want to hit that one yeah. I mean, we already have priority review.
Robert J. DeLuccia: Yeah, I mean, we already have priority review because of our FDA fast-track status. So we already have that.
Bob: Cause of our FDA fast track status.
Bob: We already have that.
David P. Luci: Yeah, but the voucher itself has value. You could actually sell that if you chose. The current market value is about $100 million. So looking at that is, you know, a source of possible funding at some.
Speaker Change: Yeah, but the voucher itself is actually.
Speaker Change: There's value to that you could actually sell that if you chose current market values about $100 million so looking at that as.
Speaker Change: The source of the possible funding at some point.
Speaker Change: Hum.
Robert J. DeLuccia: We can certainly take a look. Yeah. Okay.
Speaker Change: And we can certainly take a look but yeah.
David P. Luci: Okay, cool. I mean, the timing is right to begin thinking about it. It's associated with the NDA. So it's time to put it on the radar if it's something that the FDA could consider.
Speaker Change: Okay.
Speaker Change: I mean, the timing is right to begin thinking about it it's a it's associated with the D. M. B a so it's time to put it on the radar and if it's something that could.
Speaker Change: If the FDA would consider.
Speaker Change: Okay.
James Francis Molloy: Thank you. Our next question today is coming from James Molloy from Alliance Global Partners. Your line is now live.
Speaker Change: Thank you. Our next question today is coming from James Molloy from Alliance Global Partners. Your line is now live.
James Francis Molloy: Hey, good morning, guys. Thanks for taking my question. I apologize; I missed it on the call. Did you guys state when you anticipate starting the first of the two phase threes, and can you walk us through what the all-in costs for the phase threes are anticipated?
James Francis Molloy: Hey, good morning, guys. Thanks for taking my question.
Speaker Change: I apologize I missed it on the call did you guys see.
James Francis Molloy: When you're starting the first of the two phase threes and can you walk us through what the all in cost on the phase III.
Speaker Change: Got it.
David P. Luci: Thanks, Jim, and good morning. We hope to start, we will be ready to start in the fourth quarter of this year with enrollment based on the manufacturing update that we recently received. So we hope to be funded satisfactorily by then in order to start. So that's the gating factor.
Speaker Change: Thanks, Jim and good morning, Yeah, well, we hope to start.
Speaker Change: We will be ready to start in the fourth quarter of this year with enrollment.
Speaker Change: Manufacturing update that we recently received.
Speaker Change: So we hope to be funded satisfactorily by then in order to start so.
Speaker Change: So that's the gating factor.
David P. Luci: But yeah, we hope to start in the fourth quarter, and then enrollment should take 18 to 24 months. And it's difficult for us to guesstimate exactly how much this is gonna cost because, you know, we have a lot of partnering discussions currently ongoing. And they're all different, and they all have various internal capabilities that dramatically impact what the Phase 3 mandate will cost. It's certainly, you know, something in the 50 to 60 million dollar range if we were to do it all independently ourselves. So a partnership would be appropriate for that.
Speaker Change: But yeah, we hope to start in the fourth quarter and then.
Speaker Change: Enrollment should take 18 to 24 months and it's you know it's difficult for us to guesstimate exactly how much this is gonna clause because.
Speaker Change: Yeah, we have a lot of partnering discussions currently ongoing.
Speaker Change: And they're all different and they all have various internal capabilities that dramatically impact.
Speaker Change: What the phase III mandate will cost.
Speaker Change: It's certainly something in the $50 million to $60 million range. If we were to do it all independently.
Speaker Change: Independently ourselves.
Speaker Change: So a partnership would be it would be appropriate for us.
David P. Luci: How would you characterize the current partnership environment? And obviously, after Phase 3 is your best deal, you're obviously not there. But how would you characterize, sort of, going into Phase 3, the partnership opportunities you're seeing? Yeah, like that.
Speaker Change: How would you characterize the current partnership environment and obviously.
Speaker Change: They have after phase III is your best deal Youre, obviously not there.
Speaker Change: How would you characterize sort of going into phase III the partnership opportunities you're seeing.
David P. Luci: You know, I would characterize it as pretty robust. I mean, Probably my last 20 emails in my inbox are people wanting to meet me, and I haven't even looked at the emails yet. That's just from overnight.
Speaker Change: Yeah, I would characterize it as pretty robust I mean.
Probably my last 20 emails in my Inbox are people wanting to meet me and I haven't even looked at the emails yet that that's just from overnight I mean.
David P. Luci: I mean, there's just a lot of interest, and we may not be enrolling in phase three, but we're phase three ready. And we know we have a drug from our phase two B data. So, you know, we have to be patient, and we have to make the right deal. And, you know, when things come along that are gonna constitute, you know, 60% of the company being lost to a round of investment, you know, sometimes it's the deals that you don't do that make the most sense.
Speaker Change: It's just a.
Speaker Change: It is just a lot a lot of interest and you know where we may not be enrolling in phase III, but we're phase III ready and we know we have a drug from our phase II data.
Speaker Change: So.
Speaker Change: We have to be patient and we have to take the right deal.
Speaker Change: And you know when things come along that are going to you know constitute.
Speaker Change: 60% of the company being lost to.
A round of investment.
Speaker Change: Sometimes it's the deals that you don't do that make the most sense.
David P. Luci: So, we're trying to be judicious about raising capital as non-dilutively as possible, knowing that we have a drug and that we're phase three ready. And there aren't a lot of Phase III antibiotics out there right now. [inaudible] A Reasonable Chance to Be Frontline Therapy
Speaker Change: So we're trying to be judicious about raising capital as non dilutive Lee as possible knowing that we have a drug in our phase III ready.
Speaker Change: And there aren't a lot of phase III antibiotics out there right now.
Speaker Change: Especially not in a billion dollar plus market, where you have a you know.
Speaker Change: Oh.
Speaker Change: A reasonable chance to be frontline therapy.
David P. Luci: Okay, so maybe last questions on my end. On the design, I know that it was a year, year and a half to get to run the first of the phase threes. Is there any opportunity for any interim looks and any thoughts on timing on that? And then, any update on the past direct? What's going on?
Speaker Change: And so then maybe a last question is on my mind.
Speaker Change: On the design I know that it was a year year and a half to get to run the first of the phase III they have to.
Speaker Change: Looking for to ensure any interim looks and any thoughts on timing on that and then.
Any update on the past direct what's going on.
David P. Luci: I'll leave the question on the Pasteur Act. I'll leave it to Bob. There's some new legislation, actually old legislation that may be expanded to include antibiotics that treat life-threatening infections that Katie Britt in the Senate has gotten in touch with Healthy Human Resources about. But I'll let Bob talk about that. But the interim look thing, you know, that's kind of like a head fake. You know, I know it's NBA playoff time.
Speaker Change: Hum.
Speaker Change: I'll leave that to the question on the pass through or at least to buy there's a some some new legislation.
Speaker Change: The old legislation that may be expanded.
Speaker Change: To include antibiotics that treat life threatening infections that kt Brett in the Senate has.
Speaker Change: <unk> got in touch with our human resources about but I'll, let Bob talk about that.
But the interim look saying that that's kind of like a head fake you know I know it's M. B a playoffs time, so for U M B a fence.
David P. Luci: So for you NBA fans, you know, the interim look we would have, that would go through an independent committee of scientists and doctors. And if you take an interim look, you necessarily statistically have to add patients to the trial. And the interim look doesn't give you any sense of, you know, percentage-wise, how you're doing with the primary endpoint and secondary endpoints. All it does is this group of experts tell you to either keep going or stop due to futility. So for the amount of information you get out of that, to me, it's not worth adding millions of dollars in time to a trial.
Speaker Change: The Ah <unk>.
Bob: The interim look we would have that would go through an independent committee.
Speaker Change: Scientists and doctors and if you take an interim look you necessarily statistically you have to add patients to the trial and the interim look doesn't give you any sense of you know percentage.
Speaker Change: Percentage wise, how youre doing with the primary endpoint and secondary endpoints. All it does is this group of experts tell you.
Speaker Change:
Speaker Change: So you can either keep going or just stopped due to its utility.
Speaker Change: So for the amount of information you get out of that to me. It's not worth you know, adding millions of dollars and time to a trial.
Speaker Change: Yeah.
Robert J. DeLuccia: Yeah, I agree. I agree with you, Dave, on that for sure. And I hope that answers the question. But remember, this is a blinded trial, so you really cannot see the blind if you're going to continue to proceed. I think there was a second question there regarding...
Speaker Change: Yeah, I agree I agree with you Dave on that for sure and hope that answers answers. The question, but remember this is a blinded trial. So we really cannot break the blind isn't going to continue to proceed.
Speaker Change: Yeah.
How about the sector I think there was a second question here regarding there was about flat.
Speaker Change: Yes.
Speaker Change: What was the question.
David P. Luci: What's going on with Pasteur X? Yeah.
Speaker Change: What's going on with the pass through or ex Yeah. Fast start you know theres a lot of effort to try to get that through but really unlikely.
Robert J. DeLuccia: Yeah, Pastor, you know, there's a lot of effort to try to get that through, but it's really unlikely to occur this year under the current political environment. However, there is some activity with a special program that requires a drug to be determined as a material threat. In order to get some additional funding from a government organization called BARDA for new classes of antibiotics that are in late stage clinical trials, namely phase three.
Speaker Change: Going to occur.
Speaker Change: This year under the current political environment. However, there is some activity with a special program.
That requires a drug to be determined as a material threat.
Speaker Change: Order to get some additional funding from a government organization called Florida, four new classes of antibiotics that are in late.
Speaker Change: Late stage clinical trials, namely phase three.
Robert J. DeLuccia: So this is being circulated as pending legislation to try to move it forward this year. I wouldn't put a high probability that it's gonna get through this year, but if it does, we'll be able to tap into that for some partial funding for our phase three program. You know, Asher
Speaker Change: So this is being circulated there's as pending legislation trying to move it forward. This year I wouldn't put a high probability that that's going to get through this year, but if it does we'll be able to tap into that for some partial funding for our phase III program.
David P. Luci: You know, actually, just a slight nuance on that is that the legislation is actually old. It was approved a long time ago.
Speaker Change: Actually I just have a slight nuance.
Speaker Change: And that is that the legislation is is actually old it's been approved a long time ago.
Speaker Change: So what.
David P. Luci: What would need to happen is that the scope of the program would need to be expanded, which I understand can be done by HHS on its own. It would need to be expanded to include antimicrobials that treat life-threatening infections. So it doesn't rise to the level of needing a new law; the law is there; it's just the program needs to be expanded to include this new class of things that will ultimately be stockpiled by the federal government through the Department of Defense.
Speaker Change: What what would need to happen is that the.
Speaker Change: The scope of the program would need to be expanded which I hate to say it can be done by HHS on their own and it would need to be expanded to include antibody antimicrobials that treat life threatening infections. So it doesn't rise to the level of needing a new law. The law is there.
Speaker Change: Sure It does.
Speaker Change: The program needs to be expanded to include this new class of things.
Speaker Change: Things that ultimately will be stockpiled by the federal government through the department of defense.
Speaker Change: Yeah.
James Francis Molloy: Great, thank you for taking my question.
Speaker Change: Great. Thank you for taking my questions.
Speaker Change: Thank you Jim.
David P. Luci: Thank you. We've reached the end of our question and answer session. I'd like to turn the floor back over to you for any further or closing comments.
Speaker Change: Thank you we've reached end of our question and answer session I'd like to turn the floor back over for any further or closing comments.
David P. Luci: We'd just like to thank everyone for participating today, and thank you for your patience; the best is yet to come. Thank you. That does conclude today's teleconference. You may disconnect your line at this time, and have a wonderful day.
Speaker Change: We just like to thank everyone for participating today.
Speaker Change: Thank you for your patience and the best is yet to come.
Operator: Thank you. That does conclude today's teleconference. You may disconnect your line at this time and have a wonderful day. We thank you for your participation today.
Speaker Change: Thank you that does conclude today's teleconference. You may disconnect. Your line at this time and have a wonderful day, we thank you for your participation today.
unknown: [inaudible]
Speaker Change: Okay.
Speaker Change: Hum.