Gossamer Bio, Inc. Common Stock 12th Annual Cantor Fitzgerald Global Healthcare Conference

Absolutely. I'm on Barcelona time coming back from ERS.

It is. Yeah. 5:00 somewhere.

Sure. I think just from a macro level, then we can dive into some of the details. Definitely a lot going on. We did, as Olivia Breyer alluded to, we had our Type B pre-NDA meeting back in June, with the FDA. We got those minutes in July and in the process of working on the NDA, and we can get more into that. We did address the debt, the converter that we had due next year. So we were able to address that, as well as refinance the company. Just recently just closed on that not too long ago. So we look good from a cash perspective. Then also, we repurchased the worldwide rights of seralutinib back from our partner Chiesi. It was a strategic decision on their part.

They're going to go a different direction in ultra rare because they had some other kind of respiratory products that they are working on. Unfortunately, didn't work out, so we have kind of relegated that partnership to a very low single-digit royalty payment over the course of the patent or until we hit a specific number. Just from a kind of a high level, that's it. We did have some new data presented. I think you're familiar with our functional respiratory imaging data that we did in phase II TORREY with 19 patients. We just presented the FRI data from PROSERA at ERS with 125 patients, and that technology has certainly really advanced. The data and the effect on the pulmonary vasculature, both on the arterial and the venous side and across a capillary bed looks really promising.

Unprecedented, I think we're the first PAH, or I think Insmed did something in phase II, but in phase III, the only company, and we had about a third of the patients. That looks really promising as well and I think will differentiate us in the market.

Sure. I'm happy. Yeah, yeah.

to jump in. A couple of things that we're really excited about is one, the team that we assembled throughout the process, right? We're working with some very well-known ex-FDAers. The former director of the Cardio Renal Division, Norm Stockbridge, who has approved essentially every PAH drug that's been out there. We've worked with Hilary Marston, who was the former CMO, and then finally Mary Ross Southworth, who led safety for the Cardio Renal Division, has a lot of expertise in understanding some of the liver toxicity issues with therapies. As you know, TKI has a potential liver signal, so she's been very helpful in preparing us for that FDA meeting. The Type B meeting, we had our internal Gossamer folks. We also took four key opinion leaders, one from Europe and three from the U.S., to that meeting.

Their primary purpose really is to explain to the FDA the unmet need that still exists in this disease. The five-year morbidity to mortality rate is still horrendous despite all of the drugs that we have on the market, and we only have one drug that's kind of disease modifying that's been approved, which was sotatercept. This will be drug number two, and what we're seeing, and particularly in that imaging data, is a nice kind of reverse remodeling of the disease. The tone and tenor of the meeting was quite positive. For the people that were in the room that have done a ton of these meetings over the year, they're quite surprised about where FDA was in terms of the collaboration, them kind of laying out a roadmap for us to approval.

Going in, we weren't expecting that at all because sometimes FDA is just pretty, you know. I guess it was minute 7 into the presentation after Dr. Gafrani was going through the unmet need, Aliza Thompson, who is I think the acting director, got up and said We have no issue with filing. There's no filing issues here. Everything that we see in the briefing package and what we talked about is more of a review issue, which was great news. So we do not expect a refuse to file when we receive the acceptance in, call it late November-ish, because we plan to file the NDA here in the next few weeks or so. I don't know if you want to- Yeah.

Just some additional context there. So our top-line results in phase III, we came out with a p-value of 0.032, which cleared the traditional 0.05 threshold. But at the EMA's request, our statistical plan had a pre-specified alpha of 0.025, so we did not hit that more stringent level p-value. Because of that, we were concerned about, and as was the market, obviously, about the approvability or reviewability of the data as a whole. Now, in addition to what Bob has talked about the demeanor from the FDA, which was very, very positive and surprisingly collaborative. We also, just a few days after our meeting, the FDA revised their draft guidance, noting almost explicitly that in high unmet need rare diseases, that 0.05 is the functional standard.