Mannkind Corporation Chardan Healthcare Conference

Great. Yeah. Thank you, Andreas, and thank you all for being here. My name's Ahmed Mousa. I'm CEO of Vicore Pharma. As Andreas mentioned, Vicore is working on advancing a program called Buloxibutid for idiopathic pulmonary fibrosis. We have a mechanism that's unique in the landscape. We go after epithelial repair. Damage to the epithelium is, in our view, the first step of the disease, and attacking the disease from that perspective we think can be very fruitful, both independently in terms of a therapeutic approach, as well as then combining with other types of approaches. We're currently running a large phase IIb trial.

It's almost 400 patients, and actually, we're looking at the impact of our drug on lung function over 52 weeks, so same setup as a phase III trial in combination with available standard of care, as well as for patients who decide for different reasons not to take the standard of care, or who've tried the standard of care and couldn't tolerate it and discontinued therapy. Our large phase IIb trial follows a really nice phase IIa signal, where over 36 weeks, we actually showed that Buloxibutid was able to improve lung function. A small open label trial, but nonetheless a really nice initial signal of clinical efficacy.

And we think that's a nice precedent to then our ongoing phase IIb trial, which should hopefully be a great reflection that we can have a good drug with good safety and tolerability, as well as something that can be really impactful from a therapeutic perspective in the landscape.

Mid-next year. The trial completed enrollment in late April, and we're looking forward to reporting results- Okay Yeah, in the summer.

Thank you for having us.

Yeah. My name is Mike Castagna.

I am CEO of MannKind. We are an inhalation platform company. We have been around 35 years. We have several FDA-approved products, inhaled insulin. We have inhaled Tyvaso DPI, and one of the reasons we are here today is our inhaled nintedanib that we are working on. That is just going into phase II. We expect that to be about 140 patients testing two doses, and that will be in about 12 or 13 countries, depending on the U.S. FDA, and looking forward to today.

Thank you. Yeah. So far, I think we've dosed 60, 70 patients between healthy volunteers and IPF patients.

We've seen no inclination of diarrhea. We've seen no discontinuations for cough, nothing for tolerability. That's over multiple doses over seven days in single day studies. But so far, things look pretty good, which gave us the confidence to go in here into phase II. That's fair. So I think feel pretty good about the tolerability side effect profile. I think the question is going to be efficacy, and I think with the Tyvaso TETON readouts plus pirfenidone, we've now shown two times we can deliver drugs into the lungs and get an effect size. So we're pretty excited that hopefully this will be the trifecta here showing that lung-targeted therapies can make a difference in these patients.