Disc Medicine, Inc. Common Stock Morgan Stanley 24th Annual Global Healthcare Conference
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Good morning, everyone. My name's Sean Lerman. I'm the Head of Mid-Cap Biotech Equity Research here at Morgan Stanley, and welcome to our Global Healthcare Conference. Before we begin, just to make you aware of some important disclosures, please see the Morgan Stanley Research Disclosure website at www.morganstanley.com/researchdisclosures. If you do have any questions, please reach out to your Morgan Stanley sales representative. For this session, we have the pleasure of welcoming from Disc Medicine, their CEO, John Quisel. Thank you for your time today, John. A pleasure to host you.
Great to be here. Thank you.
Thank you. Maybe just some macro considerations to start with, and we're doing this for all our covered companies. How is the rise of China origin innovation, if at all, changing your competitive positioning and your R&D and business development playbook, if at all?
It's a great question. I think we are fortunately unaffected so far. We don't see anyone else developing GlyT1 inhibitors for our lead indication in porphyria, and similarly, that's true in the second indication in myelofibrosis anemia. We haven't really identified any competition from that sphere at this point. As you know, our pipeline programs are all transitioning towards phase III, and the lead program has phase III readout and hopefully a commercial transition shortly. So I think we've managed to kind of get beyond that competitive wave, at least at Disc.
Okay, what about AI and its adoption? Are you adopting AI within your business, and what sort of impact do you think it can have?
Yeah, we are working on that. It's still early days. I think it runs from the menial to the really. Well, even the menial is quite important, actually. As you know, in a rare disease setting, one of the most important factors in driving towards peak revenue is literally if you have a good therapy, being able to identify where the patients and their treating physicians are located, and I think that's an area where there's a lot of interesting new tools being developed.
Sure. Thank you. Last question before we dig into the meat of Disc, but maybe it is quite high on your agenda. Which policy variable, is it FDA, Medicare negotiations, MFN tariffs, global pricing, which policy variable do you think will have the most impact?
We do think a lot about MFN pricing. It impacts the perceived value of overseas markets, which itself impacts ideas about whether you might partner or develop on your own an asset, such as bitopertin, right? We are clearly committed to building in the U.S. market on our own. But strategy's still evolving in terms of overseas markets, and MFN has an impact on that.
Sure. Thank you. Right. Now to get into Disc specifically, thank you for doing that, but bitopertin in EPP and looking. I have got a couple of questions here on the APOLLO readout and the regulatory path. I guess sort of following the June Type A meeting, can you share any more detail about the feedback you received during that meeting in terms of what the FDA is looking for?
Yeah. I think broadly speaking, we and they are both focused on the APOLLO phase III trial. I think broad alignment around the endpoints. That is really about all there is to it. I think we are just in a position now where we need to deliver what is hopefully fantastic data from the phase III trial.
Thank you. On the powering, we understand that APOLLO is designed to detect roughly an 11-hour time in sunlight difference. Can you walk us through how you arrived at that powering assumption? What gives you confidence that the placebo-adjusted delta holds up in a larger, more geographically diverse study?
Yeah. The objective of the drug is to reduce the protoporphyrin IX and give these patients the freedom to spend time in light if they choose to do that. That endpoint is designed to detect the time that they choose to spend. I am using the word choose to emphasize that it is a voluntary endpoint, right? What we saw in phase II is that by and large, over time, patients who are on the active arm tend to choose to spend more time in light. We see that trending upwards. The placebo control trial in the U.S., the AURORA trial, was 4 months.
In the last month of that, you see an upward trend. When you look at the six-month open label trial in Australia, you see that continues. When we look now at snapshots of data from the long-term extension trial, to be honest, the data quality starts to erode a little bit on these diaries.
Sure. But nonetheless, what you see is patients just spending vastly more time in light.
So it appears it's kind of what you would expect. The drug gives people the biochemical ability to spend time in light within a matter of weeks. But then for patients who've spent their entire life avoiding sunlight, and often designed their entire lifestyle around that, having that newfound freedom takes a while to adjust to. So back to which month do we. So we're using the last month, this month six.
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