$AQST Q1 2026 Results - The Cleanest Post CRL Setup in Biotech History! Aquestiv [0:00-5:09]

Guru Nation, we are back with my favorite biotech stock. Possibly of all time, at least so far. And that's mainly because of the history, a quest of therapeutics and I have. We go back many years, we go back even to a company prior to it called Cam Farm. You'll remember watching videos, but I learned a lot from this stock. And I learned I have a much greater appreciation, I criticized a lot. And there's a lot of turmoil happening right now at the FDA. But they do know what they're doing. And when they make errors, they make them on the side of being cautious, which is kind of what we want, maybe not as investors, but as ultimate consumers, we are all patients at the end of the day. You got to live with it. It's a risk that you've got to take. And I know it sucks when they get that complete response letter on January 30th for their needle-free device free sublingual epinephrine film. The CRL crushed the stock and went from like five something to three something. And we've been in this range ever since waiting to see what happens next. Today's quarter one twenty twenty six earnings just got released. Like, but that CRL complete response letter did hurt the stock a lot. And today's kind of like the first good news we've had since that type A meeting with the FDA that they had back in March. So number one, the resubmission is of reaffirmed for quarter three of twenty twenty six. So that's in a couple months. The type A meeting is done. They have alignment on the study designs for both the human factors validation and the PK studies needed to address the CRL deficiencies. They changed the packaging. They change the instruction. So they're more clear. People are not going to put them on the tongue. They're not going to chew it. They're not going to snort it. They're not the dosing observation more seriously. And I think the sponsor, which is a question is going to be training probably training the sites on how to do that. Now, there was no in the CRL commercial manufacturing issues. There were no auto injector comparability issues. This is a clean CRL. They could have easily approved this thing too. And I know we're pissed. Believe me. Super pissed because we're in the middle of an AI boom. We've got our capital. Most of us have a lot of our capital in the stocking. I think we should accumulate. If we can, we have refinanced debt, which I'm going to get into. But the deficiencies from the CRL were procedural, not biology. Those are easy to fix. They're going to request accelerated review on resubmission. That's what I'm going to really pay attention to on the call tomorrow. If granted, that will put us on a class one timeline, which becomes two months of a review. But we're on track, if not early. Number two, they just refinanced the debt with oak tree, $150 million dollars, $55 million at signing, $20 million more on FDA approval, $25 million on sales milestones, and another $50 million with mutual consent. This saves them $45 million in principal payments over the next three years and pushes the maturity to 2031. Life science debt providers like oak tree do not underwrite $150 million dollars for facilities to companies they think are getting a second CRL. So the capital structure is being built for a 2027 commercial launch. That's the tail. Number three, and this is the part that I think some people are going to miss. Maybe they'll talk about on the call. They expanded the planned field force from 50 reps to 75 sales reps. So that's a 50% increase. Companies do not pay for 25 additional sales reps. If internal conviction on approval is wavering, remember, they're going to essentially have another year to plan their sales and they can still do the legwork and lay the infrastructure down and awareness. And thankfully our competitor, ARS pharma is doing our work for raising awareness that alternative is exist for auto injectors. So thank you to our competitor, ARS pharma. Shout out to them. Number four, so essentially refinance of debt, so you can hire 50% more sales force and that you can do the AQST planning and studies. So AQST 108 for Alope