AcelRx Pharmaceuticals, Inc. (NASDAQ:ACRX) Q3 2022 Earnings Call Transcript

Vincent Angotti: Yeah, I think it’s important that the partner €“ elaborating what I’ve said just for a moment, They would already have a commercial organization or that type of structure that allows them to spread the costs of an additional product over that structure. Whether it’s the pharmacovigilance, et cetera, where for us, it’s just isolated to one product. So, Raffi has done a nice job in sourcing those potential partners. Thomas, I think the second part of your question, was it about the DoD?

Unidentified Participant: Yeah, that’s right. And the potential or ongoing partnerships with DoD?

Vincent Angotti: We’ve been working with the DoD for years now, and we’ve just more recently actually had direct contact with their specific purchasers. Well, often historically, it’s gone through the wholesalers or middlemen, RFQs, et cetera. Now, we’re being contacted directly by the military. And that’s a nice change for us moving forward. Even though we’ve been working with other members of military, these are the actual end user orders of it. We also got our first indications of order from the Air Force and Navy. While they’re not typically as large as the Army or with the potential of the Army, it’s nice to see the additional branches starting to utilize or inquiry for DSUVIA based off of their addition or membership of the Joint Deployment Formulary because of DSUVIA’s availability to all military branches.

So we feel good about that moving forward. It’s been a lot of hard work behind the scenes. But now with these multiple different pathways of purchasing it through the wholesaler, directly with us and some other avenues, we feel that the momentum is really beginning to pick up with the military.

Unidentified Participant: Perhaps next question for Niyad for the EUA. Should we expect to see any new supportive data ahead of the decision, either press release or medical conference?

Pamela Palmer: We likely will publish the market research that we’re doing actually with 150 key folks that anticoagulation for CRRT, reporting this data. We actually think it’s going to be robust enough research that we would publish that. But, no, we’re not specifically moving forward for any additional data you’ll see prior to the EUA. But we will have the registrational study right on the heels of that EUA submission where we’re looking at 160 patients, a single registrational study to move towards the full approval of Niyad.

Vincent Angotti: Maybe you can comment on the fact that that study in structural organization endpoints has been discussed already with the FDA.

Pamela Palmer: Yes, the endpoints have been agreed upon. It’s a very straightforward study. It’s an anticoagulation €“ Niyad versus placebo. And the primary endpoint is activated clotting times. So, it’s a very straightforward study as far as we’re concerned.

Brandon Folkes: Perhaps one final question from us regarding the pre-filled syringe products. As we know, Niyad commercial prep is already underway. Any overlap there in terms of commercial infrastructure and preparations between these two product lines?