Acurx Pharmaceuticals - Q2 2023
August 14, 2023
Transcript
Operator (participant)
Greetings, 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. If anyone should require operator assistance during the conference, please press star zero on your telephone keypad. As a reminder, this conference is being recorded. It is now my pleasure to introduce your host, Mr. Rob Shawah, Chief Financial Officer. Thank you, sir. You may begin.
Rob Shawah (CFO)
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 Dave Luci, President and CEO of Acurx, who will give a corporate update and outlook for 2023. After that, I'll provide some highlights of the financials from the quarter ended June 30th, and then turn the call back 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 (President and CEO)
Thanks, Rob. Good morning, everyone, and thanks for joining us to review our financial results for the second quarter of 2023, also to cover some recent updates. We'd be pleased to take any questions. In the second quarter of 2023, we continued to enroll more patients in the phase II-B 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 II-B trial. 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 2023 for this purpose.
The IDMC will review the data upon the 36th patient being evaluated for the primary endpoint of clinical cure at the end of treatment and promptly provide its recommendation either to early terminate the II-B trial, as we had done with the phase II-A trial, or alternatively, to continue enrolling. We'll report the IDMC recommendation after the interim review of the data. If the IDMC recommends early termination of the II-B trial, we'll promptly report the top-line data on the primary endpoint and safety data when the 36th patient, enrolled patient, completes treatment. We anticipate completing enrollment of the 36 patient, patients, for the interim review in the coming month or two.
Operationally, we're pleased to report that the blinded observed data from the phase II-B trial has been exceptional. The trial is proceeding as expected, with no safety signals reported to date. The phase II-B 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 phase II-B trial from the initial 12 sites up to 28 sites, as we now have, and have increased 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 re-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 2023, 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 Diseases, or ECCMID, in Copenhagen.
First, a scientific poster entitled "Novel Pharmacology and Susceptibility of Ibezapolstat against C. diff Isolates with Reduced Susceptibilities to C. diff Directed Antibiotics," end quote, was presented by Dr. Kevin A. Garey, Professor and Chair, University of Houston College of Pharmacy, and the principal investigator for microbiome aspects of our ibezapolstat clinical program. Dr. Garey's work demonstrated that ibezapolstat's mechanism of action is not only bactericidal for to C. diff, but also could inhibit some of its virulence mechanisms, meaning its capability to cause disease.
Dr. Garey also noted that C. diff strains with reduced susceptibility to any of the other antibiotics used to treat C. diff, metronidazole, vancomycin, or fidaxomicin, those C. diff strains were susceptible to ibezapolstat. 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 anti-virulence effect, namely reduced flagellar movement of the C.
diff organism, was a positive, unexpected finding, reflecting the unique mode of action in inhibiting DNA pol IIIC. In the second of two presentations at ECCMID, Acurx's Executive Chairman, Bob DeLuccia, presented an update regarding the company's preclinical systemic oral and IV program for the treatment of other Gram-positive infections caused by MRSA, VRE, and DRSP. In 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 omnibus funding round for our second antibiotic candidate, ACX-375C, which is in preclinical development. We did appeal this decision based on certain modifications to the scope of our program. CARB-X's 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 the sufficiently good PK and safety properties of the compounds that we have justified the proposed lead optimization plan. CARB-X encouraged 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, 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 field 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 bacterial infections: Preparing for the next pandemic," end quote. After the presentation, it will be available on our website. In addition, we have IDWeek coming up.
The Infectious Diseases 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 A. Garey will be given on October 14th, entitled, "Elucidating the Gram-positive select- selective spectrum activity of ibezapolstat: Secondary analysis from the phase II-A trial." Secondly, Acurx will present at the symposium entitled, "New Antimicrobials in the Pipeline," on October 12th. At the symposium, Acurx' presentation will be entitled, "Novel DNA pol IIIC inhibitor, 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, D.C.
On April 27th, U.S. Senators Michael Bennet and Todd Young reintroduced the PASTEUR Act to encourage innovative drugs, drug development, targeting 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 antimicrobial resistance to superbugs, 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. 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 (CFO)
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 the three months ended June 30, 2023, were $1.7 million, compared to $0.9 million for the three months ended June 30, 2022. The increase was due to an increase in phase II-B 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 II-B trial-related costs and an increase in consulting costs. General and administrative expenses for the three months ended June 30, 2023, were $1.7 million, compared to $1.7 million for the 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. 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 13,005,128 shares outstanding as of June 30, 2023. With that, I'll turn the call back over to Dave.
Dave Luci (President and CEO)
Thanks, Rob, to all of you joining us today. We outlined 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 (participant)
Thank you. We will now be conducting a question and answer session. If you would like to ask a question, please press star one on your telephone keypad. A confirmation tone will indicate that your line is in the question queue. You may press star two if you'd like to remove your question from the queue. For participants using speaker equipment, it may be necessary to pick up your handset before pressing the star keys. One moment, please, while we pull for questions. Thank you. Our first question comes from the line of Ed Arce with H.C. Wainwright & Co. Please proceed with your question.
Thomas Yip (Equity Research Associate of Biotechnology)
Hi, good morning, everyone. This is Thomas Yip, asking a couple of questions for Ed. Thank you for taking our questions.
Dave Luci (President and CEO)
Got it.
Thomas Yip (Equity Research Associate of Biotechnology)
First, for the phase II-B study. Hey, good morning. Good, good to hear the update for Acurx. Back in March, the guidance for the phase II-B interim review was anticipated mid-year 2023. Can, can you outline some major factors that are behind this kind of shift in timing and also what are some remedies that, that, that you are implementing to address it?
Dave Luci (President and CEO)
Oh, okay. Thomas, 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, at the end of the first quarter, we guided folks that we would be done in the second half of 2023 with the II-B trial, If anything, today, we've guided folks that we're gonna be done before that.
Thomas Yip (Equity Research Associate of Biotechnology)
Okay. The latest... Yes, I do remember the latest guidance was second half. You mentioned in coming months. Is that sounds more like a third quarter or early fourth quarter events?
Dave Luci (President and CEO)
Yes. Yes. When, when I say before that, I mean before the end of the second half. Yeah, we, we do think that it will be, you know, in the coming, as I mentioned, in the coming month or two. We've had significantly better enrollment. We've plugged a new CRO into special situations, and we're starting. That's starting to bear fruit, including a substantial increase in the number of patients that are screened. And 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. In any of that, whatever the cause is, we're screening more patients, and, you know, we, we don't think we have far to go.
Thomas Yip (Equity Research Associate of Biotechnology)
Got it. You mentioned there, for the phase II-B interim analysis, there's 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 II-A study?
Dave Luci (President and CEO)
Oh, okay. Yeah, no, we don't give out the names of the members. Just to be clear, for the phase II-A study, the II-A trial was early terminated on the recommendation of our scientific advisory board, you know, which is included in our, in our slide deck and on our website. The phase II-B 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. It's different people in every case than those who serve as scientific advisory board members currently for the company and who opined on the II-A trial.
Thomas Yip (Equity Research Associate of Biotechnology)
Okay, understood. Thank you for the clarification. Perhaps one, one question regarding the CARB-X funding. Sorry to hear that three seven five not advancing to the next round. In order to be eligible for future grants, will you need a new program, or as we continue, we plan to continue three seven five will be eligible?
Dave Luci (President and CEO)
No. For each grant, whether by CARB-X or other folks like NIH, to be eligible, you know, you have to look at the RFP, the request for proposal. 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. We were excited to see that the scope of the RFP had expanded to include folks with sponsors like us. I mean, we expect, based on our conversations with CARB-X, that that will continue. As we continue to develop our drug, get through lead optimization, we think our candidacy will become more and more compelling in these challenging times for, for money.
Thomas Yip (Equity Research Associate of Biotechnology)
I see. 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. Cash runway should extend beyond that, but can you give us perhaps a more specific timeframe for approximate cash runway?
Dave Luci (President and CEO)
Sure, Thomas. You know, I, I think our, our cash runway is sufficient through Q3 of 2024 and, and kinda, and then some. We're burning $2.1 million-$2.2 million per quarter, and that's during, you know, the, you know, quite expensive II-B trial times. Once the II-B trial is over, we should eliminate probably $1 million of that $2.1 million-$2.2 million quarterly burn. If you take $2.2 million, and you flatline it for four quarters, that's $8.8 million. Even if the II-B, you know, for some reason, got extended, you know, enormously long, we'd, we'd have money through Q3, and given where we are, we'd probably have money all the way through 2024 because the II-B will be over.
Thomas Yip (Equity Research Associate of Biotechnology)
Okay, understood. Thank you again for taking our questions, and looking forward to the interim analysis for the phase II-B study.
Dave Luci (President and CEO)
No, 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 (Equity Research Associate of Biotechnology)
Definitely. Thank you.
Operator (participant)
Thank you. Our next question comes from the line of Jason McCarthy with Maxim Group. Please proceed with your question.
Michael Okunewitch (Senior Analyst of Biotechnology)
Hey, guys, this is Michael Okunewitch on the line for Jason. Thank you so much for taking my questions today.
Dave Luci (President and CEO)
No problem.
Michael Okunewitch (Senior Analyst of Biotechnology)
Um-
Dave Luci (President and CEO)
Thanks for calling, Mike.
Michael Okunewitch (Senior Analyst of Biotechnology)
Yeah, so I'd like to see if you could talk a little bit more about the specifics of the PASTEUR Act. Obviously, just the validation of the problem and that, you know, Congress is paying attention to this is huge in itself, what specifics have been suggested that could aid in clinical development and uptake of new anti-infectives, particularly as it relates to Acurx?
Dave Luci (President and CEO)
Sure, no problem, Mike. Because this is, you know, the... This is the transitional piece of legislation that would completely redefine the antibiotic sector in the United States. You know, 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, it's a game changer. What the PASTEUR Act does generally, and there's also a PASTEUR Light that I'll get to. The PASTEUR Act, if approved, is a, is a pull incentive, like the pull incentive similar to the pull incentive already approved and made law in the U.K. a few years back.
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 or an old class. If that's what you have, we'll pay for phase III, including all the manufacturing for phase III, and we'll give you between $750 million and $3 billion over a 10-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.
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 a Critical Need Antimicrobial designation letter. It will include a dollar amount, which will be under the current draft of the law of PASTEUR Light, at least $375 million over 10 years. 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.
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. In the case of C. difficile, the reinfection market in C. difficile has a price tag of $4.7 billion to U.S. public health every year. Patients that have recurrent C. diff infection with the cost, the total cost of treating those reinfections, from the hospitalizations to the medicines that are being used, is $4.7 billion a year.
In our case, if we come out with an antibiotic that's, you know, frontline capable, treating C. diff patients with anything close to 100% cure rate and anything close to 0% reinfections, I think that would have a significant value savings to public health in the U.S. Not the full $4.7 billion, that is the, the cost of the reinfection market for C. diff every year in the U.S., but it, it would be significant, but at the very least, it would be $375 million to us, $37.5 million a year for 10 years. As a $30 million market cap company, you could see if we were designated as a Critical Need Antimicrobial under the PASTEUR Act, it would be an absolute game changer.
Michael Okunewitch (Senior Analyst of Biotechnology)
You know, certainly, there's a lot of potential there. Just a follow-up on the phase II-B, I'd like to 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 that study.
Dave Luci (President and CEO)
Okay, great. No problem. So the microbiome changes, you know, that's the easier question, so I'll answer it first. You know, we, we see the full restoration of a fully healthy microbiome in our C. diff patients that we've treated by the end of the third day of a 10-day treatment regimen on our drug. That's from the phase II-A trial. We have no reason to expect that'll change because of the scientific underpinning of no reinfections. Why are there no reinfections? Because we're fully restoring the microbiome, you know, by day three of treatment. How are we 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 vancomycin, the standard of care, which decimates the, the healthy microbiome while it's curing the direct C. diff infection, you know, putting that patient at high risk for a reinfection. Based on that, the microbiome, we believe, is going to be a big part of the story because it's going to help us avoid reinfections. Although that's a secondary endpoint, you know, it's a big part of the story. Now, the primary endpoint of cures at end of treatment, 10 days of treatment measured, plus or minus two days at day 12 or 11, you know, those cures reflect the fact that we're getting over 100x the concentration of our medicine to the site of the C. diff infection in the colon, than is needed to kill the C. diff bacteria based on our MICs, minimum inhibitory concentration studies.
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 II-B data. The 31 patients that are enrolled are evaluated. The, you know, 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 two-arm trial, we would still be able to achieve statistical non-inferiority.
On that basis, and given we have 65 years of clinical trial data to look at for how vancomycin is going to do in our trial, you know, and you see it never gets higher than 92%, and it's been as low as 70%. Over 65 years, it's gonna be in the kind of low 80s. You know, we, we're feeling very bullish on our possibility that getting through this binary endpoint. Then you have to ask yourselves, what's the intrinsic value of this drug, in the C. diff market to big pharma? A $1.7 billion market, and with a clear shot at frontline therapy, you'd have to ask, what's that worth? When you're asking yourself, what's that worth?
You could reasonably look at, for example, the Tillotts Pharma acquisition of the EU rights to Merck's fidaxomicin, last line in the U.S., for about $125 million in 2022. That would seem, that's just European rights, and we have U.S., Europe, and Japan. You could also look at the March 23 Sebela Pharmaceuticals deal to buy Destiny Pharma for, in a structured deal, totaling $570 million. That was a much earlier stage development program than we have. The intrinsic value is quite high. We got to get through this binary phase II-B trial readout, and we're really excited about where we go from there.
Michael Okunewitch (Senior Analyst of Biotechnology)
All right. Thank you. I really appreciate your additional insights here.
Dave Luci (President and CEO)
No problem. Thank you, Mike.
Operator (participant)
Thank you. Our next question comes from the line of Jim Molloy with Alliance Global Partners. Please proceed with your question.
Jim Molloy (Managing Director and Senior Equity Analyst of Biotechnology and Specialty Pharmaceuticals)
Hi. Good morning. Thank you for taking my question. I had a question on the, on the CARB-X. Can you walk through sort of what next steps are for ACX-375C? Is there an opportunity to move forward absent the CARB-X funding? When did CARB-X notify you guys that they weren't going to proceed forward with ACX-375C?
Dave Luci (President and CEO)
The CARB-X folks notified us, kind of probably two weeks ago, late in July. We followed up with questions and an appeal, and that process took two weeks to kind of meander through. The timing is perfect for this call. The program never stopped. 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 gonna have a stronger and stronger chance at the next CARB-X RFP that comes out, that we get picked up if, you know, within the scope of that RFP. If it includes gram-positive treating antibiotics, we'll apply again with a more compelling package.
We feel that, you know, because we weren't term-- we weren't rejected back in April, like others were, we feel we're, like, kind of on the bubble, and we just have to kind of push forward, present a little bit more R&D, and then we feel that we'll be, we'll be successful.
Jim Molloy (Managing Director and Senior Equity Analyst of Biotechnology and Specialty Pharmaceuticals)
When do you anticipate the next opportunity to apply for CARB-X funding will occur? It sounded like it was a bit up in the air.
Dave Luci (President and CEO)
Well, they, they do an RFP every November. You know, there may be other RFPs that they do, but pretty much every November, they seem to come out with an RFP that we've noticed. The only question will be whether that RFP continues to include Gram-positive treating antibiotics. If it does, we'll reapply in the fourth quarter and, you know, hope for a positive recon, you know, reconsideration in April.
Jim Molloy (Managing Director and Senior Equity Analyst of Biotechnology and Specialty Pharmaceuticals)
Got it. Thank you. On the, on the phase II-B, how long from the, from the, for the fifth and final patient, 36th patient, coming in to final, final data or final notification by the IDMC on what next steps are?
Dave Luci (President and CEO)
If you assume the, the 36th patient came in today, that 36th patient would be out of the study 10 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 recommendation. As soon as we have that, so basically a couple of weeks. As soon as we have that recommendation from the IDMC, we'll put out a press release. Well, 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 the recommendation. Of course, we'll probably take it, so that'd be the second press release.
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'll put out a press release with all of the data on the primary and secondary endpoints.
Jim Molloy (Managing Director and Senior Equity Analyst of Biotechnology and Specialty Pharmaceuticals)
It certainly seems a, a positive signs for, for potential early termination. given the historical data on Vanco and the data you guys have seen, even though it's still blinded. Assuming that you have to run the to the 36, you're only halfway through, presumably you have to run to the 72nd patient. What's the, what's the, what are the, what's the thinking going forward on that? What's the, what's the ability of, of Acurx to sort of fund that second half of this trial, if it's needed?
Dave Luci (President and CEO)
Yeah, I mean, if it's, if we have to go to the 72, we'll be able to continue to fund the trial in the ordinary course. As I mentioned on, you know, if we have to keep paying $2.2 million per quarter for our ongoing costs, that's fine. You know, we could raise a, a tiny amount of money, you know, $5 million, whatever the number might be, just to kind of pick up some international sites and pay for them. You know, high enrolling Eastern European sites and Canadian sites.
Just following up on, you know, how did Summit Therapeutics manage to enroll so quickly during COVID? That's, you know, in our estimation, that's kind of how they did it. They opened up the international sites in high enrolling areas that weren't terribly impacted by the pandemic. That's what we would do if we had to do another 36. It would be adding new trial sites, international trial sites, and, you know, kind of expanding in that way to make sure it didn't take as long.
Jim Molloy (Managing Director and Senior Equity Analyst of Biotechnology and Specialty Pharmaceuticals)
Understood. Then what, on the PASTEUR Act, I know it's a bit out of your - completely out of your control, what should, what should we be looking for, for the next, the next catalyst to potentially give an idea of what might be coming out of this, if anything, on, the PASTEUR Act or PASTEUR Light?
Dave Luci (President and CEO)
Yeah, you know, I mean, we, it's funny, you know, I mean, as you know, as investment are aware, when you're dealing with the government and the, you know, kind of movements and maneuver, you know, expertise of the government, when things get approved, you know, it's just extremely difficult to benchmark and to handicap. You know, the Antimicrobials Working Group meets every month and continues, you know, which we're a member. They continue to, you know, kind of go back and forth on, you know, when it would be that PASTEUR would be passed and whether it would be PASTEUR or PASTEUR Light. You know, the best we could say is it's looking very positive for PASTEUR Light, not for PASTEUR. PASTEUR Light by itself is like a six-run home run for us.
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 U.K., which paves the way for us. We can't speak as to timing, but wouldn't it be ironic if this delay in 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, that would be great. Jim, do we still have you?
Operator (participant)
Sorry. Excuse me. If you would like to ask a question, please press star one on your telephone keypad. Our next question comes from the line of Nick Meyer, who is a private investor. Please proceed with your question.
Nick Meyer (Shareholder)
Good morning, David. Quick question on the IDMC and the data readout. Does the FDA have to approve the IDMC's recommendation, or are they not, not involved?
Dave Luci (President and CEO)
Hi, Nick. Good morning. Thanks for your question.
Nick Meyer (Shareholder)
Hi.
Dave Luci (President and CEO)
The FDA is not involved any longer. They had to approve. Well, they didn't have to approve. They had to accept our amendment to our trial protocol and our related IND, in order to provide for this IDMC mechanism. That's it. The IDMC is free to make whatever recommendation that they feel is most appropriate, the FDA, you know, won't review any of it until we get to an application for FDA approval.
Nick Meyer (Shareholder)
Okay. The IDMC is only looking at the primary metric, which is clinical cure. They're not looking at the secondary metrics at all for their recommendation?
Dave Luci (President and CEO)
Well, they're only looking at the end of treatment, but also the safety.
Nick Meyer (Shareholder)
Yep, that makes sense. The last question I have is, what, what is the value pivot between, if you were to do an M&A before phase III or going to the, an interim look on the first leg of phase III? What is your consideration there?
Dave Luci (President and CEO)
Well, you know, I would, I would take that question and reference the bio industry guide. You know, what they have is like a blue book for personal injury lawyers, where they, they have a percentage likelihood of FDA approval when you're in preclinical phase I, phase II, phase III, for any disease indication, including infectious disease, right? If you're able to get halfway through the first of two phase III registration studies and show consistent data with everything before it, you know, you, you have about a 30% likelihood of failure in phase III for all antibiotics. When you zero in on antibiotics that treat Gram-positive infections instead of Gram-negative, you know, that's probably down to a 10% or 15% 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 IIIs. it, it would be a significant, a significant value enhancement. you know, that might be offset by having an even worse stock market then than we have when we come out with the II-B 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, that is an absolute game changer, even under PASTEUR Light, that would have a dramatic impact on what we're able to sell for. Now, we could sell before getting that designation.
Hypothetically, if PASTEUR is passed and we're not yet designated, even though it would seem that we would be, you know, one of the most qualifying of potential candidates, it could be a contingent value right in a, a deal that could be negotiated, you know, prior to having the designation. We would just have to consider the various factors as we continue to talk to potential partners.
Nick Meyer (Shareholder)
Okay. Is there a specific market value that you're looking for? Or is that-
Dave Luci (President and CEO)
No.
Nick Meyer (Shareholder)
Is that going to be duty determined?
Dave Luci (President and CEO)
No, it's going to be. It's all kind of, and then just going to have to, you know, evaluate offers that we may get and consider the intrinsic value of the program. You know, whether or not the offer is within a range that is acceptable. Of course, we'll have, you know, advice from the banking side. You know, likely a fairness opinion will 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. It, it's all going to be kind of deal related. You know, it's, you know, and, and the board doesn't, you know, if we're trading at a low valuation and someone's trying to, you know, undercut real value, the board can, can say no.
Nick Meyer (Shareholder)
Yep, that makes sense. All right. Thank you for answering the questions. Appreciate it.
Dave Luci (President and CEO)
No problem. Thank you, Nick.
Operator (participant)
Thank you. We have reached the end of our question and answer session. With that, this will conclude today's teleconference. You may disconnect your lines at this time. Thank you for your participation.
Dave Luci (President and CEO)
Thank you.