Aquestive Therapeutics, Inc. Common Stock 12th Annual Cantor Fitzgerald Global Healthcare Conference

Thanks for having us. Thanks for having us.

Sure. Happy to. Kristen, thank you for having us back. As always, it's great to be here. In the past when we've talked about the company, we've talked about some of the things we've done over the years, but today I'll say we're an emerging commercial pharmaceutical company. Because as you know, I'm sure we'll spend most of our time today on Anaphylm, which is dibutepinephrine sublingual film, which, if approved by the FDA, would be indicated for the treatment of severe allergic reactions, including anaphylaxis. But with that product about to go back to the FDA and hopefully get through the FDA in the next few months, we really see our story as a commercial story.

As you know, the big hook with our product, I know you know I do this all the time, is that it is very portable, goes on the back of the phone, along with all of the clinical benefits that we'll talk about as we go through today.

Sure. So we received a CRL just over 8 months ago, and it was an interesting CRL. Never good to get a CRL, but there were some interesting things that we found in that CRL that have now made what we believe our package to be much stronger than it was. But the heart of the CRL was around packaging and Instructions for Use. The FDA said that our packaging was too difficult to open and that our Instructions for Use were not as clear as they needed to be for an emergency situation. However, we also learned in that CRL that the key clinical questions of our product had been answered. So from a clinical perspective, the FDA was supportive of approval.

We also, as we go back to submission right now, know that because the FDA asked us to do an off-label administration, so put the product on top of the tongue instead of under the tongue. We also know that even if you don't put the product in the oral cavity the way you're supposed to, that we get a pharmacodynamic effect that is meaningful. So we're going in with a package that has better packaging, clear Instructions for Use. We know the key clinical questions have been answered, and we know even if you don't administer it correctly, you still get a good pharmacodynamic response.

You don't have it with you. But for people who do carry an EpiPen, when you're in a crisis situation, and I'll pass it over to Matt in a second here, every second matters. But when you look at the data, our second human factor study, which is part of the core package that we'll put in, shows that the average person, this is across 100 people, took about 17 seconds to open our product, take it out of the package, and administer it. That's faster than what's in the public domain for the auto-injector and the other medical devices. So we now have the fastest product from a time perspective. But Matt, maybe you could talk about why that's important.

Yeah. The longer an allergic reaction goes on, the more severe it's going to get, so you want to stop this as soon as you can. You have a medicine that is very rapidly active in the body. You can take advantage of that. You can get it out of the package and into your body quickly, and once it's in your body, you see rapid peak onset of very robust effects. So that's sort of an ideal situation. You have to carry it with you, but we've had this talk before.