Acurx Pharmaceuticals, Inc. (ACXP) on Q2 2023 Results - Earnings Call Transcript
Operator: Greetings, and welcome to the Acurx Pharmaceuticals to discuss Second Quarter 2023 Financial Results and Business Update. At this time, all participants are in a listen-only mode. A brief question and answer session will follow the formal presentation. [Operator Instructions] As a reminder, this conference is being recorded. It is now my pleasure to introduce your host, Mr. Rob Shawah, Chief Financial Officer. Thank you, sir. You may begin.
Rob Shawah: Thank you. 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 2023, which is available on our website at acurxpharma.com. Joining me today is David Luci, President and CEO of Acurx, who will give a corporate update and outlook for 2023. After that, I'll provide some highlights to the financials from the quarter-ended March 30th, 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. 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 Friday August 11, 2023. You are cautioned not to place undue reliance on these forward-looking statements and Acurx disclaims any obligation to update such statements at any time in the future. This conference call contains time-sensitive information that's accurate only as of the date of this live broadcast today, August 14, 2023. Acurx undertakes no obligation to revise or update any forward-looking statements to reflect events or circumstances after the date and time of this conference call. I'll now turn the call over to Dave Luci. Dave?
Dave Luci: Thanks, Rob. Good morning, everyone, and thanks for joining us to review our financial results for the second quarter of '23 and also to cover some recent updates, then we'd be pleased to take any questions. In the second quarter of 2023, we continued to enroll more patients in the Phase 2b clinical trial of our lead antibiotic candidate ibezapolstat for the treatment of patients with C. difficile infection or CDI. We're pleased to report we now have enrolled 31 patients in the Phase 2b trial. It's only five more patients need to be enrolled to trigger interim data review by an Independent Data Monitoring Committee that we appointed in the first quarter of ‘23 for this purpose, The IDMC will review the data upon the 36 patient being evaluated for the primary endpoint of clinical cure at the end of treatment and properly provide us recommendation either to early terminate the 2b trial as we had done with the Phase 2a trial or alternatively to continue enrolling. We will report the IDMC recommendation after the interim review of the data, if the IDMC recommends early termination of the 2b trial, we will properly report the top-line data and the primary endpoint and safety data when the 36 patient – enrolled patient completes treatment, we anticipate completing enrollment of the 36 patients for the interim review in the coming month or two. Operationally, we're pleased to report that the blinded observe data from the Phase 2b trial has been exceptional and the trial is proceeding as expected with no safety signals reported to-date. The phase 2b trial protocol includes an exploratory endpoint comparing the impact on the microbiome between ibezapolstat and standard-of-care oral vancomycin. In the event non-inferiority of ibezapolstat to Vancomycin is demonstrated, further analysis will be conducted to test for superiority. Due to slower than expected enrollment, during the COVID-19 pandemic and its aftermath, we did expand the number of trial sites participating in the 2b trial from the initial 12 sites up to 28 sites as we now have and have increased to support to higher enrolling sites resulting in increased screening in the past couple of months. In March 2023, the FDA accepted our protocol amendment to our IND, which will allow an Independent Data Monitoring Committee to review the interim data that's been pre-cleared with the FDA. We remain particularly excited about the dual impact of ibezapolstat at the same time to treat the acute infection the C diff infection, while appropriately managing the long-term care of each patient's microbiome, which we believe is exceptional for antibiotic therapy. Other key highlights from the second quarter of ‘23 or in some cases shortly thereafter include the following: In April of this year two presentations were made at the 33 Annual European Congress of Clinical Microbiology and Infectious Disease or ECCMID in Copenhagen, first decided to the poster entitled “Novel Pharmacology and Susceptibility of Ibezapolstat Against C. diff Isolates with Reduced Susceptibilities to C. diff Directed Antibiotics” was presented by Dr. Kevin Gary, Professor and Chair University of Houston College of Pharmacy and the Principal Investigator for Microbiome Aspects of our ibezapolstat clinical program. After Gary's work, demonstrated that ibezapolstat’s mechanism of action is not only bactericidal to C. diff, but also could inhibit some of its virulence mechanisms meaning its capability to cause disease. Dr. Gary also noted that C.diff strains with reduced to susceptibility to any of the other antibiotics are used to treat C. diff, metronidazole vancomycin or fidaxomicin, those C. diff strains were susceptible to ibezapolstat. So just to say it again, ibezapolstat is able to successfully kill C. diff bacteria that in many cases is resistant to all the other antibiotics used to treat C. diff currently. Ibezapolstat’s antivirulence effect namely reduced flagellar movement of the C. diff organism was a positive unexpected finding, reflecting the unique mode of action and inhibiting DNA pol IIIC. In a second S2 presentations at ECCMID Acurx Executive Chairman, Bob DeLuccia, presented an update regarding the Company's preclinical, systemic oral and IV program for treatment of other gram-positive infections caused by MRSA, VRE and DRSP at the "Pipeline Corner" featured session at ECCMID, organized by Dr. Ursula Theuretzbacher, a world-renowned microbiology expert involved in antibacterial drug research, discovery and development strategies and policies for clinical and public health needs. Bob summarized the progress of the company's gram- positive Select Spectrum Program. Both posters are available on our website. Additionally, in the third quarter, we were notified by CARB-X that we did not receive funding approval in their recently closed ‘23 omni-bus funding round for our second antibiotic candidate ACX375C, which is in preclinical development. We did appeal this decision based on certain modifications to the scope of our program. However, CARB-X governance structure did not allow for acceptance of an appeal process. CARB-X noted that the ‘23 round of funding was very competitive and that their Scientific Advisory Board was enthusiastic about Pol IIIC as the bacterial target of our molecules and that's a sufficiently good PK and safety properties of the compounds that we have justified the proposed lead optimization plan. CARB-X encourage us to reapply for future Requests For Proposals or RFPS that CARB-X will continue to promulgate from time-to-time for funding consideration. While this news was disappointing, we will continue to monitor and apply for grants from all funding sources as they become available. Now, just, now looking forward just a bit, the upcoming Antimicrobial Resistance Congress is next month. It will convene its Annual Meeting in Philadelphia where experts in the fields from both the public and private sectors weigh in on the latest innovations to address antimicrobial resistance. This is the world's largest conference for all stakeholders combating antimicrobial resistance and our Executive Chairman will speak at the innovation showcase section of the conference on September 7th and will present an update entitled “Novel DNA Pol IIIC Inhibitors for Gram-Positive Bacteria Infections Preparing for the Next Pandemic”. After the presentation it will be available on our website. In addition, we have IDWeek coming up, the Infectious Disease Society of America will convene its Annual Meeting called IDWeek in Boston, October 11 to 15. Acurx will be featured at two scheduled events. First, an oral presentation by Dr. Kevin Gary will be given on October 14th entitled Elucidating The Gram-positive’s Selective Spectrum Activity of ibezapolstat Secondary Analysis from the Phase 2a trial. And secondly, Acurx will present at the Symposium entitled “New Antimicrobials in the Pipeline” on October 12. At this symposium, Acurx presentation will be entitled “Novel DNA Pol IIIC Inhibitors For Gram Positive Bacterial Infections”. After this presentation it too will be available on our website. Now to the PASTEUR Act. As we've discussed in the past, the Bipartisan PASTEUR Act continues to generate news and enthusiasm in Washington DC. On April, 27th, US Senators Michael Bennet and Todd Young reintroduced the PASTEUR Act to encourage innovative drugs - drug developments targeting in the most threatening infections, improve the appropriate use of antibiotics and ensure domestic availability of antibiotics when needed. On July 11th, a Senate Subcommittee hearing was convened and led by Senators Markey and Marshall highlighting, the need to address the Antimicrobial Resistance to Super Bugs, including MRSA, and C. diff. Accordingly, we're quite enthusiastic about the prospects of the PASTEUR Act being passed into law on the Bipartisan support significant national spotlight and dire need for new classes of antibiotics to treat serious and life-threatening infections. And now back to our CFO, Rob Shawah to guide you through the highlights of our financial results for the second quarter of 2023. Rob?
Rob Shawah: Thanks, Dave. Our financial results for the second quarter ended June, 30 2023 were included in our press release issued earlier this morning. The company ended the second quarter with cash totaling $9.1 million, compared to 9.1 million as of December 31, 2022. Research and development expenses for three months, ended June, 30 2023 were $1.7 million compared to $0.9 million for three months ended June 30, 2022. The increase was due to an increase in Phase 2b trial-related costs. For the six months ended June, 30 2023, research and development expenses were $2.8 million versus $1.7 million for the six months ended June 30, 2022. The increase is due primarily to Phase 2b trial-related cost and an increase in consulting costs. General and administrative expenses for three months ended June, 30, 2023 were $1.7 million, compared to $1.7 million for three months ended June 30, 2022. The expenses reflect a slight decrease in professional fees of $0.1 million, offset by a slight increase of $0.1 million in employee compensation-related costs. For the six months ended June, 30 2023, general, and administrative expenses were $3.6 million versus $3.6 million for the six months ended June 30 2022. The amount reflects a decrease in professional fees of $0.2 million, offset by an increase of $0.2 million in employee compensation-related costs. The company reported a net loss of $3.4 million or $0.28 per diluted share for the three months ended, June 30 2023, compared to a net loss of $2.6 million or $0.26 per diluted share for the three months ended June 30 2022 and a net loss of $6.3 million or $0.53 per share for the six months ended June, 30 2023, compared to a net loss of $5.3 million or $0.52 per diluted share for the six months ended June 30 2022 all for the reasons previously mentioned. The company had 13,000,5128 shares outstanding as of June, 30 2023. With that, I'll turn the call back over to Dave.
Dave Luci : Thanks, Rob, and to all of you joining us today. We outlined the advances in several areas that we believe will spur continued momentum and growth, build on our strong fundamentals. We look forward to sustaining this momentum even during these challenging times and sharing future updates and results in the coming months. I will now open the call for any questions. Operator?
Operator: Thank you. [Operator Instructions] Thank you. Our first question comes from the line of Ed Arce with HC. Wainwright, please proceed with your question.
Thomas Yip: Hi, good morning, everyone. This is Thomas Yip asking couple of questions for Ed. Thank you for taking our questions.
Dave Luci: Hi, Ed. Good morning.
Thomas Yip: Perhaps first with the Phase 2b study – hey, good morning. It’s good to hear the update for Acurx. So back in March, the guidance for the Phase 2b interim review was anticipated mid-year 2023. Can you outline some major factors that are behind this shift and finding and also some remedies that that you are implementing to address it?
Dave Luci: Okay. Tom is that, I mean, I think the question is about 180 degrees in the wrong direction, I'm sorry to say. If you check your notes, I think you'll find that on May 14th in the first - at the end of the first quarter, we guided folks that we would be done in the second half of 2023 with the 2b trial and if anything today, we've guided folks that we're going to be done before that.
Thomas Yip: Okay. So, the latest, yes, I do remember the latest guidance was second half. So you mentioned in coming months, so is that sounds more like a third quarter or early fourth quarter events?
Dave Luci: Yes. Yes. So, when I say before that, I mean, before the end of the second half. But yeah, we do think that it will be, in the come – as I mentioned in the coming month or two, we've had significantly better enrollments. We’ve plugged a new CRO into special situations and we're starting - that started a bear fruit including a substantial increase in the number of patients that are screened. So it maybe it's also in combination a bit with COVID being further and further behind us and maybe some of the behavioral patterns are changing back. So in any event, whatever the cause is, we are screening more patience and we don't think we have far to go.
Thomas Yip: Got it. And then, you mentioned there for the Phase 2n interim analysis there is a new IDMC. Can you give some details on members on this board? And is it the same core members as the IDMC for the Phase 2a study?
Dave Luci: Okay. Yeah, no, we so we don't give out the names of the members. But just to be clear, for the Phase 2a study, the 2a trial was early terminated on the recommendation of our Scientific Advisory Board, which is included in our in our slide deck and on our website. But the Phase 2b trial for it, we had to create a separate Independent Data Monitoring Committee and these are all independent scientific experts in infectious disease and in one case a statistician, none of which have shares in our company or get paid by our company and they're doing this as a public service. That's the constituency of the IDMC. Its different people in every case than those who served as Scientific Advisory Board members currently for the company and who will pine on the 2a trial.
Thomas Yip: Okay. Understood. Thank you for the clarification. Perhaps, one question regarding the CapEx funding? Sorry to hear that the recent fund back advancing to the next round. In order to be eligible for future grants, we need a new program or do we continue we plan to continue at least 75 would be eligible?
Dave Luci: No. So, for each grant, whether by CARB-X or other folks, like NIH to be eligible, you have to look at the RFP the Request For Proposal. So with CARB-X in particular, this was the first CARB-X grant RFP in years that allowed folks who are developing antibiotics that target treatment of gram-positive bacteria infections, not just gram negative. So, we were excited to see that the scope of the RFP has expanded to include folks sponsors like us. I mean, we expect based on our conversations with CARB-X that that will continue. And as we continue to develop our drug, gets through lead optimization, we think our candidacy will become more and more compelling in these challenging times for money.
Thomas Yip: Excellent. Okay. Perhaps one last question from us, this one is financial. It sounds like, as you mentioned earlier, the interim analysis seems to be occurring really soon. So, cash runway should expand beyond that. Can you give us, perhaps a more specific timeframe for approximate cash runway?
Rob Shawah : Sure, Tom. I think our cash runway is sufficient through Q3 of 2024 and kind of and then some. So we are burning $2.1 million, $2.2 million per quarter and that’s during the quite expensive 2b trial times. So once the 2b trial is over, we should eliminate probably $1 million of that. $2.1 million, $2.2 million quarterly burn. So, if you take $2.2 million and you flat line it for four quarters that's $8.8 million. So even if the 2b for some reason got extended enormously long, we'd have money through Q3, and given where we are, we probably have money all the way through ‘24 because the 2b will be over.
Thomas Yip: Okay. Understood. Thank you for taking our questions. And I'm just looking forward to the interim analysis for the Phase 2b study.
Rob Shawah : No problem. Thomas. If you have any other questions, just give me a call or shoot me an email and we'll connect.
Thomas Yip: Definitely. Thank you.
Operator: Thank you. Our next question comes from the line of Jason McCarthy with Maxim Group. Please proceed with your question.
Michael Okunewitch: Hey guys. This is Michael Okunewitch on the line for Jason. Thank you so much for taking my questions today.
Dave Luci: No problem. Thanks for calling, Mike.
Michael Okunewitch: Yeah. So, like to see if you could talk a little bit more about the specifics of the past year active, obviously just a validation of the problem and that Congress is paying attention to this is huge and itself. But what specifics have been suggested that could aid in a clinical development and uptake of new anti-infectives in particularly as it relates to Acurx?
Dave Luci: Sure. No problem, Mike. I think this is the - this is the transitional piece of legislation that would completely redefine the antibiotic sector in the United States. Just to be perfectly clear, this puts antibiotics back on par profit-wise, revenue-wise with cancer drugs and diabetes drugs, neurological drugs for ALS and other neurological disorders. It's a game changer. So what the Pasteur Act does generally and there's also a Pasteur alike that I'll get to the Pasteur Act if approved is a pull incentive, like the similar to the pull incentive already approved and made law in the UK a few years back. And what the pull incentive does is, it says, hey, sponsors of new antibiotics and those who invest in them, if you invest in an antibiotic if you take your time to develop an antibiotic for a life-saving or serious clinical indication that is a new class of antibiotics, not just a new generation of amoxicillin an old class. If that's what you have, we will pay for Phase 3 including all the manufacturing for Phase 3 and we will give you between 750 million dollars and $3 billion over a ten-year period of time in order to stockpile your antibiotic at Public Health Facilities over a 10-year period of time under a license agreement with health and human services. Pasteur light would be basically half of that. So it would be $375 million minimum up to $1.5 billion for each sponsor of QIDP, an antibiotic that treats serious or life-threatening infections and is a new class of antibiotics. Each sponsor can only get one designation under the Pasteur Act to get the designation you get a letter from HHS after you apply and get accepted. And that's critical need antimicrobial designation letter. It will include a dollar amount which will be under the current draft of the law of the Pasteur Light through a light at least $375 million over 10 years and the amount between $375 million and $1.5 billion over 10 years under Pasteur light will be determined by HHS based on a formula to be provided in the law. And basically that formula will try to get to the savings to the public health system in the United States by having your antibiotic approved to treat these serious and life-threatening infections. So in the case of C. difficile, the reinfection market in C. difficile has a price tag of $4.7 billion dollars to the US Public Health every year. So, patients that have recurrent C. diff infection with the total cost of treating those reinfections from the hospitalizations to the medicines that are being used is $4.7 billion a year. So in our case, if we come out with an antibiotic that’s frontline capable, treating C. diff patients with anything close to a 100% cure rate and anything close to 0% reinfections, I think that would have a significant value savings to Public Health in the US. That's a full $4.7 billion that is the cost of the reinfection market for C. diff every year in the US, but it would be significant. But at the very least, it would be $375 million to us $37.5 million a year for 10 years. So, as a $30 million dollar market cap company, you can see if we were designated as a critical need antimicrobial under the Pasteur Act it would be an absolute game changer.
Michael Okunewitch: Certainly there's a lot of potential there. And just a follow-up on the Phase 2b, I’d like see if you could provide then a bit more color on the potential to possibly stop it early on efficacy. What would need to be demonstrated? And then expand a little bit on how you can use changes in the microbiome, in addition to the primary endpoint to support a readout on a study?
Dave Luci: Okay. Great. No problem. So the microbiome changes, that's the easier question. So I answer it first. We see the rest of the full restoration of the fully healthy microbiome in RC diff patients that we've treated by the end of the third day of attending a treatment regimen on our drug, and that's from the Phase 2a trial. We have no reason to expect that will change because of the scientific underpinning of no re-infections why? Why are there no re-infections? Because we're fully restoring the microbiome by day three of treatment and how are we re-restoring the microbiome? Well, we have a very narrow spectrum antibiotic that's only able to kill C-diff leaving all of the other classes of healthy bacteria in the gut alone, providing them an environment where they can kind of repair themselves unlike the normal antibiotic like, the Vancomycin and the standard-of-care, which decimates that the healthy microbiome while it's curing, the direct C. diff infection putting that patient at high risk for a re-infection. So, based on that the microbiome, we believe there is going to be a big part of the story, because it's going to help us avoid re-infections. And although that's a secondary endpoint, it's a big part of the story. Now the primary endpoint of cure us at end of treatment and days of treatment measures plus or minus two days, at day 12 or 11 those cures reflect the fact that we're getting over 100 times the concentration of our medicine to the site of the C. diff infection in the colon that is needed to kill the C. diff bacteria based on our MICs Minimum Inhibitory Concentration studies. So that's why - that's the underpinning for why we're so successful at killing the bacteria at end of treatment and that's the primary endpoint. We expect that to continue when we read out the 2b data, the 31 patients there are evaluated the blinded observed data is tremendous. And our statisticians say, if there are up to two patients who are not cures out of the 36 patients evaluated at the interim, look, even if those two patients are on our side of the 2 on trial, We would still be able to achieve statistical non-inferiority. So, on that basis, and given we have 65 years of clinical trial data to look at for how Vanco is going to do in our trial and you see it never gets higher than 92% and it's been as low as 70% over 65 years it's going to be in the kind of low 80s. So, we're feeling very bullish on our possibilities that getting through this binary endpoint. And then you have to ask yourselves, what's the intrinsic value of this drug in the C. diff market to big pharma at $1.7 billion market, and with a clear shot at frontline therapy, you'd have to ask what's that worth? And when you're asking yourself, what's that worth you could reasonably look at for example, the Tillots Pharma acquisition of the EU rights to Merck’s fidaxomicin last night in the US for about $125 million in 2022, that would see that's just European rights. And we have us Europe and Japan. And you could also look at the March 23 Sabel Pharmaceuticals deal to buy Destiny Pharma for in a structured deal, totaling $570 million. And that was a much earlier stage development program than we have. So, the intrinsic value is quite high. We got to get through this binary Phase 2B trial read out, and we're really excited about where we go from this.
Michael Okunewitch: All right. Thank you. I really appreciate your additional insights here.
Dave Luci: No problem. Thank you, Mike.
Operator: Thank you. And our next question comes from the line of Jim Molloy with Alliance Global Partners. Please proceed with your question.
Jim Molloy : Hi, good morning. Thanks for my question. I had a question on the, on the CARB-X you walk through so, what next steps are for. 375C, is there an opportunity to move forward absent the CARB-X funding? And when did the CARB-X notified you guys that they weren't going to proceed forward with 375?
Dave Luci: The CARB-X notified us kind of probably a couple of weeks ago, late in July, and we followed up with questions and an appeal in that process took a couple of weeks ago to kind of meander through. So the timing is perfect for this call. But the program never stops. We continue to evaluate and work on the lead optimization process, which is why I say that, as that process continues and gets to completion, we're going to have a stronger and stronger chance at the next CARB-X RFP that comes out that we get picked up if, it would have the scope of that RFP. If it includes a gram-positive treating antibiotics we will apply again with a more compelling package. And we feel that, because we weren't rejected back in April, like, no others were. We feel we’re like, kind of on the bubble just have to kind of push forward, present a little bit more R&D and then we feel that we will be will be successful.
Jim Molloy : I want you to expect the next opportunity to apply for CARB-X funding will occur. It sounded like it was a bit up in the air.
Dave Luci: Well, they do an RFP every November. There may be other RFPs that they do, but pretty much every November they seem to come out with an RFP that would have noticed. But the only question will be whether that RFP continues to include gram-positive treating antibiotic. If it does we will reapply in the fourth quarter and, hope we are – with the positive reconsideration in April.
Jim Molloy : Got it. Thank you. Then on the on the Phase 2b, how long from the for the fifth and final patient - 36 patient coming in the final date or final notification for the IDMC on what next steps are?
Dave Luci: So, if you assume a, the 36 patient came in today, that 36th patient would be out of the study ten days from today. And they would be evaluated for the primary endpoint two days thereafter. So 12 days from today. After that the IDMC will meet day 13, day 14, like that and come back with their recommendations. As soon as we have that recommendation, so basically a couple of weeks because we have that recommendation from the IDMC, we will put out a press release, but first, we'll put out a press release that we got to the 36th patient. The second press release will be the IDMC recommendation, and the company's decision to take or not take their recommendation, of course, we will probably take it. So that would be the second press release. And then assuming the IDMC recommends that we early terminate then when that 36th patient is completely out of the trial and we have a final study report, we will put out a press release with all of the data on the primary and secondary endpoints.
Jim Molloy : And it certainly seems a positive signs for potential early termination given the historical data on vanco and the data you guys are seeing even though it's still blinded, but what assuming that you have to run - your you get, get the 36 you're like, halfway through presuming if you run for the 72nd, patient what's the thinking going forward on that? And what's your, what's your ability of Acurx to the fund that second half of this trial, if it's needed?
Dave Luci: Yeah. I mean, if it's - if we have to go to the 72 , we will be able to continue to run the trial in the ordinary course, as I mentioned on, if we have to be paying $2.2 million per quarter for our ongoing cost, that's fine. We could raise a tiny amount of money, $5 million whatever the number might be. Just to kind of pick up some international sites and pay for them. High and rolling Eastern European sites and Canadian sites. Just following up on how did - Therapeutics managed to enroll so quickly during COVID and that that's, in our estimation that's kind of how they did it. They opened up the international sites and in high rolling areas that weren't terribly impacted by the pandemic. So, that's what we would do if we had to do another 36. It would be adding new trial sites, international trial sites, And kind of expanding in that way to make sure it didn't take as long.
Jim Molloy : Understood. And then what, and on the Pasteur Act, I don't know it's a bit – that’s clearly out of your control, but what should what you've been looking for the next catalyst and potentially give an idea of what might be coming out of this if anything on the Pasteur or Pasteuyr Light?
Dave Luci: Yeah, I mean, it's why, I mean, as you know as investors are aware, when you're dealing with the government and the kind of movements and when in the government when things get approved, it's just extremely difficult to benchmark it's a handicap . The antimicrobial working group meets every month and continues, which were a member, it continues to kind of go back and forth on when it would be the Pasteur will be passing and whether it would be Pasteur or Pasteur Light, the best we can say is, it's looking very positive for Pasteur Light, not for Pasteur. Pasteur Light by itself is like a 6 round home run for us. And we think that public health needs it. And that's been made very clear by those in public health. It's already approved in the UK, which paves the way for us. So, we can't speak at the timing, but wouldn't it be ironic if this delay and the enrollment leads us to an M&A situation where Pasteur is passed and we can capitalize on it before we were able to do a transaction. That would be great.
Rob Shawah: Jim, do we still have you?
Operator: Sorry, excuse me. [Operator Instructions] Our next question comes from the line of Nick Meyer who is a private investor. Please proceed with your question.
Unidentified Analyst: Good morning, David. One question on the IDMC and the data readout. So, does the FDA have to approve the IDMC’s recommendation? Or are they left, are they not at not involved?
Dave Luci: Hi Nick. Good morning. Thanks for asking. No, the FDA is not involved any longer. They had to approve whether they have to approve. They had to accept our amendment to a trial protocol and our related IND in order to provide for this IDMC mechanism. But that's it. The IDMC is free to make whatever recommendation that they feel is most appropriate. And the FDA won't review any of it until we get to an application for FDA approval.
Unidentified Analyst: Okay. And then the IDMC is only looking at the primary metric, which is clinical cure. They're not looking at the secondary metrics at all for the recommendation?
Dave Luci: Well. They're, they're only looking at the primary end of treatment, but also for safety.
Unidentified Analyst: Yes. That makes sense. And then the last question I have is, what is the value pivot between, if you were to do an M&A before Phase 3? Or going to the interim look on the first leg of Phase 3? What is your consideration there?
Dave Luci: Well, I would take that question and reference the bioindustry guide. What they have is like, a Blue Book for personal injury lawyers where they have a percentage likelihood of FDA approval when you're in preclinical Phase 1, Phase 2, Phase 3 for any disease indication including infectious disease, right? So, if you are able to get halfway through first of basically registration studies and show consistent data with everything before it, you have about a 30% likelihood of failure in Phase 3 for all antibiotics. When you zero in on antibiotics that treat gram-positive infections instead of gram-negative, that's probably down to a 10% or 15% percent failure rate. And you could probably chop that failure rate in half when you present interim data on the first half of the, first of the two Phase 3s. So , it would be a significant value enhancement. And that might be offset by having an even worse stock market than then we have when we come out with the 2b data, it's hard to say. The biggest bogey will be, if the Pasteur Act is passed, and we get designated as a critical need antimicrobial, that is an absolute game changer even under Pasteur Light that would have a dramatic impact on what we we’re able to sell for. Now, we could sell before getting that designation. So hypothetically, if Pasteur is passed and we're not yet designated, even though it would seem that we would be, one of the most qualifying a potential candidates. It could be a contingent value, right, in a deal that could be negotiated prior to having the designation. And we would just have to consider the various factors as we continue to talk to potential partners.
Unidentified Analyst: Okay. But is there a specific market value that you're looking for? Or is that is that going to be determined?
Dave Luci: Yeah, it's going to be - it's all – we just going to have to evaluate all that we may get and consider the intrinsic value of the payments, whether or not the offer is within a range that is acceptable. And of course, we'll have advice from the banking side likely a fairness opinion would be involved to make sure that our bankers think that whatever terms are being offered. And the Board accepts are fair to go into that acceptance by the Board. So it's all going to be kind of deal related and the Board doesn't - if we're trading at a low valuation and someone's trying to undercut the real value. The Board can say, no.
Dave Luci: Yes. That makes sense. All right. Thank you for answering the questions. Appreciate it.
Dave Luci: No problem. Thank you, Nick.
Operator: Thank you. We have reached the end of our question-and-answer session. And with that, this will conclude today's teleconference
