Unidentified Participant: Okay. Then follow-up is the original Phase IIa and b studies, you said were to prove non-inferiority, was it your expectation at the time that it would indeed prove clinically superior? And was that a disappointment that it did not or was that just not something you were measuring at all?
David Luci: Well, originally, that was the plan, to measure for statistical noninferiority, and if proven, to test for superiority. But just like with the independent data monitoring committee mechanism, those mechanisms kind of got put to bed when we decided to end the Phase IIb trial early because there are so few patients evaluable in the IIb. There was no mathematical mechanism to measure for non-inferiority or superiority. So in Phase II, unlike registration in Phase III trials, you need to establish clinical comparability to move on to Phase III. So we decided that since we are looking at the blinded data and it looks so positive, you could see how many failures there were, or in our case, there were not, that it was certain to us that we would be able to establish clinical comparability and move on to Phase III.
So we didn’t want to — for a number of reasons, we didn’t want to waste the time, the money and not have our drug at market as soon as possible. We figured we have a win on the table here, let’s take it off the table and move on.
Unidentified Participant: Okay. Thank you. One last question is since October 2, we’ve had some very wild swings in the price of this Acurx with the company with some days as many as and exceeding 8 million — almost 10 million shares being traded in a single day, which is pretty unusual. Do you have any comments on that?
David Luci: No. I mean, we came out with data, right? So we’re going to be coming out with even more data. Three to five solid press releases in the next kind of period of time ending at the end of the first quarter. So we expect to have a lot more high-volume days between now and the end of the first quarter. I will note that as part of the corporate maturation process, this is what happens. At the end of 2022, we were trading about 21,000 shares a day, if you recall, average daily trading volume. So now as you look at it in the rearview mirror, as Bob says, we’re now entering kind of the mid-life of microcap pharmaceutical company. And as we become Phase III ready in every sense, it’s – we expect the trend to continue.
What I like about it and what I will say as well, I like the notion that it seems to me, and this will be coming out more and more through public filings of our ownership. It seems to me that more and more of our shares are entering institutional hands, which is another thing that’s very healthy for the company.
Unidentified Participant: All right. Thank you.
David Luci: Thank you, John.
Operator: Thank you. Our next question is from the line of Ryan Mulholland (ph) with 50-50 LLC (ph). Please go ahead.
Unidentified Participant: Hi, David. Thank you very much for taking the time. Just a couple of questions. One regarding the Phase IIb trial and the randomization. Was that a block randomization that was used? And are we to assume that the two incomplete participants were then from the vancomycin arm? And then second question — you can go for it.
David Luci: Yeah. I was just going to say, I don’t know what a block randomization is, and I wouldn’t assume — I don’t know the two protocol violators, I don’t know which arm they were in. What I can tell you is that the randomization in the IIb was done at the local level as opposed to a centralized randomization. So I think that means it’s not a block randomization. But I’m not entirely sure where the two protocol vials have come out.
Unidentified Participant: Okay. Thank you. Do you know if that information will be forthcoming?
David Luci: I mean, I don’t expect to know. I haven’t asked because they’re protocol violators. So there’s nothing that I can assume if I had that information. So I don’t even think I asked, so the numbers are not evaluated.
Unidentified Participant: And then lastly, over the past year you’ve had several discussions, several interviews where you have discussed potential M&A participation and your kind of interest in not taking maybe ibezapolstat over to Phase III yourself, but finding a partner. Is that still something that’s on your radar? And are there interesting parties who have signed NDAs to investigate that interest on their own?
David Luci: Yes. So there’s a lot to bite off there. But yes, we do have NDAs signed in some cases, with interested parties. They being confidential, I can’t tell you the names. And yes, M&A is definitely on our calendar for 2024. We think sharing risk with a big pharma partner for Phase III in the commercial period is a prudent idea. Now it takes two parties to create a deal. I’m not certain whether or not a deal will come to fruition. And we won’t know what our value is until we unveil and find out what the secondary and exploratory endpoints are from the recently completed trial. So we kind of have to have that information in order to formally launch that process. But in the first quarter of the year, I’m sure we’ll formally start the process with an asterisk that if we were to get a term sheet in the meantime, then we would be forced — if they were within the ballpark that the Board of Directors find generally interesting, then they may form a special committee and have us move forward earlier than we expected.
But that’s about it. So for now, I would just refer you to the most recent deals in the C. diff space that have been consummated. And you can kind of get an idea of what evaluations are like. So one deal from November 2020 was when Astellas sold European rights to fidaxomicin, to Tillotts Pharma AG in Europe. And another deal was the Destiny Pharma deal with Sebela Pharmaceuticals, which look big, $540 million, but that was only $1 million upfront and the $540 million of all of that money isn’t payable until the very end of the marketing period, which, I don’t know, might be 15 or 20 years out. So those are the comparables that we see in the space. And we’ll look at our data. And hopefully our data shows a clear separation and we’re able to get something done in terms of M&A in 2024.
And we’ll be working on a parallel track with Phase III preparation, and we’ll see how far we get with each.
