Ampio Pharmaceuticals, Inc. (AMPE) on Q1 2021 Results - Earnings Call Transcript
Operator: Thank you, and welcome to the Ampio Pharmaceuticals First Quarter 2021 Earnings Result and Business Update Webinar. As a reminder, this call is being recorded. At this time, I would like to turn the call over to Mr. Dan Stokely, CFO. Dan, please.
Dan Stokely: Yes. Thank you very much. And I hope everyone's having a great day. It's our pleasure, me and the rest of the Ampio executive management team, to be present today. And we'd like to thank each one of you for attending our first quarter 2021 financial results and business update call either via phone or the webcast. Prior to reading the safe harbor forward-looking statement, I'd like to introduce you to the members of the executive management team of Ampio Pharmaceuticals, who will be both presenting and participating on the call today. First, here with us at the company headquarters in Englewood, Colorado, is Mr. Mike Macaluso, the Chairman and Chief Executive Officer. We also have present, Dr. David Bar-Or, Director and Founder; Holli Cherevka, the company's Chief Operating Officer; and me, Dan Stokely, the Chief Financial Officer.
Mike Macaluso: Thanks, Dan. So what do we've been doing since last we spoke, I believe that was early March of this year. My answer to that would be, I suggest we've been improving. So what does Ampio Pharmaceuticals do? And does Ampio only treat osteoarthritis of the knee? I suggest I do not believe that statement. I believe Ampion can treat any joint, including but not limited to the hand, hips and shoulders. I believe it will even work better in those other joints because they are under less stress than the knee. If this statement is true, then we are an osteoarthritis company, which is far more valuable than an osteoarthritis of the knee company. Is Ampio a COVID company? No. I don't think that either. Ampio does not attempt to cure COVID nor do we make vaccines. We treat the inflammation created by the immune response to the COVID virus. Ampion is agnostic and as such is unbiased whether the inflammation is caused by the any other of the 6,000 or so mutations of the virus or what the cause of the inflammatory response is. So Ampion treats inflammation, not the virus. But won't COVID disappear soon if we focus too strongly on that? Not according to the Center of Disease Control or Nature magazine or Nature journal. We will live with this virus or mutations of this virus for many, many years to come. Pfizer, on BBC last night, confirmed this statement. Herd immunity will not be the solution either, in part because of the mutation and in the research published by Nature journal, it used Israel as an example of this. Even though Israel has vaccinated the majority of their population, the surrounding countries have vaccinated less than 2% of their population and we live in a global and very mobile economy. The India pandemic is dealing with a double mutation of the virus that many suggest may be impervious to the current vaccines. How long will that double mutation be confined to just India alone? That's an interesting question. One last point. Always follow the money. If the virus will soon be a thing of the past, why are pharmaceutical companies continuing to make this virus a high-level priority and continue to invest billions in the expansion of vaccine manufacturing capacity? Then there's a long hauler or long COVID complications, which if you do not die from the virus could be worse than the virus itself. There are also complications with the vaccine, which may or not become a problem in the future. A number of years ago, Dr. Bar-Or and I made a trip to New York to meet with the head of an international healthcare, very large and prestigious bank. He had great credentials. He was an MD, PhD, and MBA.
Dr. David Bar-Or: Thank you, Michael. And good afternoon, everyone. So today, we'll update you on some of the research advances Ampio has accomplished in the past few months. And first, I would like to mention that this work is a result of intense efforts by a very talented science team of molecular biologists, biochemists, computational biologists and regulatory specialists under my direction and supported by our experienced and world renowned scientific advisory board members. I will try to simplify this update, but I recognize that some of this research topics are not trivial and maybe difficult to follow for people not familiar with this scientific concept. A comprehensive science presentation to the scientific advisory members and to the Ampio Board of Directors was made last month that included all our advanced discoveries in inflammation pathways associated with Ampion treatment of acute kidney injuries, COVID-19 and the rare children condition of protein losing enteropathy, or PLE, in post Fontan procedure.
Dan Stokely: Okay. We're ready to open up the call, moderator.
Operator:
Dan Stokely: The first question received on the Q&A side of the webcast is this, I would like to structure the PT trials differently to expedite trial .
Mike Macaluso: Yes. We structure it differently. I think the structure is very similar and the structure is really determined by the FDA and the IRB more than us. What we've done is added significantly more hospitals. So our goal, for example, in the inhalation study is to have 6 to 10 hospitals and the same thing with the IV study and we're also going to do that in multiple countries. As I mentioned, that will be in Israel and the United States, but we also may be adding India to the inhalation study and some other countries that are experiencing what we would call a spike of the virus. So we're in those discussions. Now we've already signed up numerous hospitals for this. So the key to doing it quicker is just having more hospitals to enroll patients.
Dan Stokely: Next question is somewhat similar about given the proven safety profile of Ampion, has there been any effort to approach the potential nebulizer COVID-19 market in India?
Mike Macaluso: Of course. As I mentioned during my talk, we're in those discussions actually today and we've been looking at it for a while. They're suggesting the pandemic in India is not even peaked yet. So with 300-some thousand new cases every day, and I believe honestly myself been to India, that number's probably way higher. We hope to be doing something in India very soon.
Dan Stokely: Next question is what is in that guidance regarding OAK from the FDA and what are those multiple pathways exactly? Can you elaborate on that please?
Holli Cherevka: Sure. Thank you, Dan. And thank you, everyone, for dialing in. The FDA has acknowledged the impact of COVID-19 on clinical trials and provided both general guidance to industry and specific guidance to Ampio. The FDA recently provided us with technical details and technical guidance on opportunities to move our program forward. At a high level, those encompass 3 main areas. First, they provided statistical guidance and methodology for appropriate analysis during the COVID-19 pandemic and how to approach the study. Next, they provided opportunity for different approaches to study enrollment should additional enrollments be needed to offset those patients who may or may not have been impacted by COVID and/or who may or may not have missed ascertainments or visits due to the COVID-19 pandemic and have been documented as such. And third, overall guidance provided on the general protocol on the approach to maintaining or not maintaining a special protocol assessment. At present, we are currently engaged in a special protocol assessment with the agency and we continue to remain blinded and that continues to be a priority for the company. However, the FDA provided several options and opportunities related to the overall management of the protocol, statistical analysis and enrollment. Mike, would you want to add anything?
Mike Macaluso: Yes. I mean, when you look at this for us now, this could be the last trial. And since our goal, as I mentioned in my introduction, is to partner this, never to do it ourselves nor file the BLA or build a commercial infrastructure, we want to have those discussions and we're in those discussions. As I mentioned, they've already begun. So if we were to unblind now and if the pharmaceutical company, for example, that would be our partner, wanted to have a different label or a different pricing assumptions that would have to be done before we unblind, so that we make sure that whatever we've done would meet that criteria. Again, I don't know what those assumptions would be. Our potential partners would know who that is or what that is. So we're going to -- we're in those discussions. But like I said in my top, I would be happy. I'd love to unblind that data and use that as evidence. But once I do that, the chance to adjust it, change it or add more patients if they wanted for an additional label would disappear. So we're going to -- we're cleaning the data so that we can make a quick decision or have access to it quickly. We're doing that. We started on it about a month ago. So whatever needs to happen, we're ready to have it happen.
Dan Stokely: Next question similar on that topic of partners. It would seem that the decision to unblind or add to the trial is the most important in company history. Why would we allow potential partners to give input on that strategy without a signed agreement in place?
Mike Macaluso: Yes. You're right. We wouldn't. That would be stupid. Won't do that.
Dan Stokely: And just to elaborate, there's been a lot of questions on, do you have a partner as a potential partner? We're still in the potential partner phase. Nothing's been finalized or contract decided. So that's why there's not a book.
Mike Macaluso: So let me add to that. Until we had clarity from the FDA that we did not have to rerun the trial, okay, it was pretty hard to have any meaningful discussions. But once we have now some flexibility with the FDA and some options to choose from, we can re-engage in those discussions. And as I said, they've already started. We're not talking about we're going to do it. It's already happening.
Dan Stokely: Next question is for you, Dr. Bar-Or. It's a long question and Ampion use in inflammatory symptoms of this condition and how it's very similar, not identical to patients diagnosed with ME, damaged CFS after viral exposure across the blood brain barrier and
Dr. David Bar-Or: CFS, you mean.
Dan Stokely: Yes, I'm just reading.
Dr. David Bar-Or: CSF. Yes. It's a very long question and I apologize if I'm not responding to all of the elements. But does Ampion cross the blood-brain barrier? I'm not sure. I don't know. But it does have an effect on vascular permeability. What was the other portion?
Dan Stokely: It's a longer question. I'm trying to cut it short. But it basically said, how it is very similar and identical to patients diagnosed with CSF after viral exposure? Can Ampion cross the.
Dr. David Bar-Or: Is it -- patients diagnosed with encephalitis? Is that what is meant? So encephalitis is a viral disease. Yes, it's caused by -- it can be caused by many viruses. The herpes virus is one of them. And in that regard, when you have encephalitis, the blood barrier is disrupted. And therefore, a lot of compounds will cross the blood-brain barrier when there is inflammation. When there is a tumor, for example, the blood-brain barrier is disrupted and will allow compounds that normally will not go through -- pass-through.
Dan Stokely: Okay. I think we're ready to go to the telephone calls.
Operator: Certainly. Your first question is coming from Jonathan Aschoff.
Jonathan Aschoff: I thought it was just going to be a webcast, so I sent it in. But it's kind of redundant, I think, based on what you've already been answering. They were simply, can you please help us better understand exactly what your different options are for moving forward in OAK 4. And then I was wondering, with these potential partners, given the Phase III delay, do you need to rekindle those relationships in order to talk about the best path forward with them? Or have you had continuous dialogue with these potential partners over the past, say, 14 months?
Mike Macaluso: We have stayed in touch, Jonathan. Thanks for the question. Yes, we've stayed in touch and they were constantly calling us looking for updates. So it's a lot easier to talk to big pharmas that have 15 or 20 companies that were shut down by the pandemic than it is for maybe an investor who doesn't understand the complexities of these things. So pharma understand what we were going through because they're going through exactly the same thing. But we stayed in touch. We were in contact, probably I would say, once a month. They would call and ask for an update. And now that we have an update, as soon as we -- as soon as I was able to call and say, listen, I received yesterday confirmation from the FDA that we didn't have to re-run the trial, that they gave us certain options. I'd like to discuss these options with you. Let's set up a meeting and talk about it, get your team together. And we're doing that. So now those conversations are going to have a lot more impact. We have a lot more to talk about. We could share with them the guidance and also what we're doing. What's interesting, Jonathan, is also that -- I guess maybe because just the weather changes in the world, there a lot more interested today. I guess maybe because we have human results and we're starting other trials, and what's going on in the ARDS and in the COVID inhalation study, the long hauler study. So we're starting to entertain those discussions as well. Our goal would be to be able to have someone who could help us with this whole platform development. And those are the discussions we're having now, going forward. And as I said, they started yesterday. Next question, operator?
Operator: Your next question -- you're next is coming from William .
Unidentified Analyst: Yes, this is William . About 30 million Americans suffer from peripheral neuropathy, for which there is no cure thus far. And peripheral neuropathy, as I understand it, is exacerbated by inflammation. And so I'm just wondering if this is an area that you find yourselves looking at maybe in the future.
Dr. David Bar-Or: This is David Bar-Or responding. So yes, peripheral neuropathy is caused by what you call neuropathic pain. And Ampion does address neuropathic pain and nociceptive pain, both of them. And we have experience with that. There is a great need for treatment for diabetic peripheral neuropathy and other kinds of neuropathies. And for that purpose, we have developed a cream that seems to be pretty effective in that condition, an Ampion cream.
Mike Macaluso: Next question, operator?
Operator: Your next question is coming from Ron .
Unidentified Analyst: Just a quick question. So how long will it take for the data to be cleaned and approximately how long will take, do you figure, until big pharma or any other pharmaceutical company is actually ready to sit down and finalize this?
Mike Macaluso: Cleaning the data will take about a month or maybe two. And when will the pharma finalize this? I don't know. I can't answer that. I don't have a crystal ball. I know there's interest. I know we're working on it. I know we needed to complete some things before we could fully engage those discussions. We can do that now. We have people helping us set up those meetings. And the sooner the better is my answer, Ron. Next question, operator, please.
Operator: Your next question is coming from . We have no further questions from the lines at this time.
Dan Stokely: Mike, did you want to provide some closing remarks.
Mike Macaluso: Yes. Thank you, Dan. Yes, I do. I just want to tell you -- let me see if I have notes here. Look, we've got a lot going on, but no deviation from the plan. So everything we're doing right now is to prepare ourselves for those discussions. We want to get our trials enrolled. We want to get our trials -- we want to get the results as soon as possible. We want to address the pandemic in the areas where they're the most prevalent. So we're talking to people from around the world. Recognize that sometimes getting a trial started here in the United States could take 6 months. We're told in India, it wouldn't take anywhere -- not even half that long, but we'll see. It's taken us awhile to get started in Israel. It started taking us awhile to get the long hauler stuff. We're still waiting on the IRB. The IRB is delayed simply because there has to be an agreement between the FDA and the IRB, and I guess us and the physicians on clinical end points. So we're working on that. We hope that is completed this week and we're ready to start these trials. So I'll keep you guys informed as to what we're doing. But I feel a lot better going into these discussions now than I did a year ago. And I think we're in a good position to complete our mission. And I'll keep you posted and let you know as we make progress. Thank you.
Operator: Thank you, ladies and gentlemen. This does conclude today's event. You may disconnect at this time, and have a wonderful day. Thank you for your participation.
