Corinne Jenkins (Managing Director, Goldman Sachs) : Okay. Maybe pivoting a little bit. Pemvi’s also in development for alcohol use disorder and alcohol liver disease. Maybe talk to us about why those made sense in the context of this particular agent and its properties.
Jerry Durso (President, CEO, and Chairman of the Board, Altimmune) : Corinne, that comes back to what we believe is the value of bringing both the direct-acting liver impact of the glucagon side of pemvidutide and the metabolic effects. I think if we think about both of those patient populations, the drinking is an issue. We know that it leads to implications on the liver over time. We are approaching it with the potential to be able to address both sides of that. The emergence of the understanding of the role that GLP can play on the craving mechanism and on the impact of the drinking, we think is only part of the equation, even for the AUD population. Although this is a continuum, there are ALD patients who are obviously also suffering from AUD.
Jerry Durso (President, CEO, and Chairman of the Board, Altimmune) : There has been a perception that the AUD patients weren’t always suffering liver complications yet, and I think there’s an emergence of thinking and actions progress. You have to be thinking about the liver maybe even earlier than anticipated. While the phase II data is primarily the data set that we’ll read out next quarter in AUD, is primarily focused on the impact on drinking. We see the opportunity over time to really bring the benefit of both an impact on the liver and hopefully a positive impact on the level of drinking to the equation. We don’t look at this as only solving one part of the equation. We think because of Pemvi’s broad benefit on both sides, that it could be bringing different than some of the other options that might be approached there.
Corinne Jenkins (Managing Director, Goldman Sachs) : Okay. How should we think about the market opportunity in each of those indications and the unmet need in terms of patients that might be candidates for a therapeutic intervention?
Jerry Durso (President, CEO, and Chairman of the Board, Altimmune) : The unmet need is high. We know that if you look at some of the data, there are large populations, 12 million or so with AUD. Might be half of that or so with ALD. No approved drugs in ALD. A few older options with AUD. We know a high level of unmet need. I think importantly, again, it’s going to be about defining what the therapeutic impact you can deliver. It is a market development need. You have to understand how to find the right segments of patients to be able to bring on board. Large unmet need. We think we can deliver, if the data supports it, something unique there. If that’s the case, then it’s going to be about understanding the right business case and how best to pursue.
Corinne Jenkins (Managing Director, Goldman Sachs) : Yeah
Jerry Durso (President, CEO, and Chairman of the Board, Altimmune) : We’re encouraged by the level of the potential of the mechanism. The unmet need is high. It’s indications that we feel a company like Altimmune should be exploring.
Corinne Jenkins (Managing Director, Goldman Sachs) : To that point, what do you need to see from these phase programs?
Jerry Durso (President, CEO, and Chairman of the Board, Altimmune) : We’ll see the AUD study. Obviously, we set up that study, as I mentioned, primarily around the impact on drinking, although we’ll capture the full liver enzymes, et cetera. We’ll look at weight. We want to see the impact on drinking. The decrease in the number of heavy drinking days is the primary endpoint of that study. We have some of the potential regulatory endpoints as a secondary impact on the WHO classification, for example. We’ll look at the totality of the data, see what we’re seeing, have a discussion with the FDA, make a determination what we think the potential is. Then come back and update on what the options and the plan will be. We have talked about if we’re in that positive scenario where we believe there’s value there.
Jerry Durso (President, CEO, and Chairman of the Board, Altimmune) : Maybe, Greg, you want to mention how we think about the financial element on that, because of course, we have some milestones to get through in terms of understanding the data and the regulatory endpoint. Of course, we’re always thinking and working about the what-ifs along the way.
Greg Weaver (CFO, Altimmune) : Well, a phase III thinking as we go forward in these two new indications is important, and the framework of existing balance sheet and MASH imperatives as the foundation. Yeah, we are beginning to do the work. I think as we turn over the card in AUD, get the regulatory feedback, we’ll in parallel be looking at optionality on how we might position that phase III funding and take that forward. If the value is there, we’ll get it done. I think the likely preference is going to be non-dilutive. It could be a partner, could be strategic, could be regional, could be some other flavor, and not a default to new equity issuers. No, we’re excited about it.
Greg Weaver (CFO, Altimmune) : This is a very exciting time for the company between kicking off the MASH trial, the AUD reading out, ALD moving forward, and just all the detail work that’s going on to, on the financial side, create a little more precision around the forecasting, a little more certainty around what that use of cash and burn rate could look like going forward.
Corinne Jenkins (Managing Director, Goldman Sachs) : Great. Maybe just to clarify, I guess we’ll have the data next quarter.
Jerry Durso (President, CEO, and Chairman of the Board, Altimmune) : Yeah.
Jupp: Kroppen evner ikke å ta opp nødvendig mengde C-vitamin gjennom magen, men om man kjører shiten rett i blodet? Oh yeah.
