Aldeyra Therapeutics, Inc. (NASDAQ:ALDX) Q4 2022 Earnings Call Transcript

So, I’m really quite thrilled about the commercial prospects of ADX-2191 for all those reasons, the advantages of the drug combined with the fact that there’s a targetable physician population combined with the fact that there’s no therapy approved for these indications. For Reproxalap, one of the efforts we’re pursuing internally is initial commercialization. You can expect that, that is a very thorough process that we will be prepared, if necessary, to launch internally. As I’ve said before, with mass market drugs, it’s not always optimal for small companies to launch. But in the ocular space, it is certainly feasible. We’ve seen it many times before. I think we’re right on target to the extent that we need to do that if we’re unable to secure the partnering deals that’s accessible.

Justin Kim: Okay. Great. And maybe just then on the (ph) program. Can you just discuss 246 and differentiation compared to 629? Just sort of any thoughts on indications that maybe better suited for the sort of earlier-stage asset with safety and tol?

Todd Brady: Right. ADX-246 is our most potent RASP modulator yet. It is a direct product of our RASP modulator platform, which is really designed to select for new candidates that — or effective RASP modulators, but also exhibit the kinds of pharmacokinetic properties we would desire for an orally administered drug. ADX-629, as you know, has been administered twice daily. There’s the potential for 246 to be administered once daily, because not only is 246 more potent than 629, it also could have a more favorable dosage administration profile. 248 is similar, also a very potent RASP trap, but, in this case, will be formulated specifically for intravitreal injection for geographic atrophy and dark adaptation in patients with the dry form of AMD.

Justin Kim: Great. Thanks.

Todd Brady: Thanks, Justin.

Operator: Thank you. Our next question is from Kelly Shi from Jefferies. Kelly, please go ahead. Your line is open.

Unidentified Analyst: our questions. So, I want to follow-up on the 246. Todd, can you give us more color on the systemic immune-mediated diseases? Any details on specific indications you are pursuing? My second question is on the runway. I just want to confirm that the runway to second half 2024 includes both the launch plan for Repro and 2191 and the projected revenue of both assets? Thank you.

Todd Brady: Good morning, (ph). Thanks for your question. And I think your 246 question relates to Justin’s question about indications for 246. ADX-246, we’ll initiate a Phase 1 clinical trial first. The idea there is to confirm safety and some of the pharmacokinetic advantages that I was highlighting in response to Justin’s question. My expectation is that ADX-246 will inherit some of the indications where ADX-629 is being trialed today. Examples might include chronic cough or atopic dermatitis or alcohol-associated hepatitis. I think we need to see the results from the ADX-629 trial and then to the extent there is activity that we could consider shifting molecules to 246, particularly for some of the mass market indications.

I’d also expect that ADX-629 will remain on the orphan side of the equation. So, as you know, we have two orphan indications that are being tested currently; one is idiopathic nephrotic syndrome and the other one is Sjogren-Larsson syndrome. Happy to briefly comment on cash, and Bruce feel free to fill in as well. But the guidance is very clear. We have cash into the second half of next year. That cash supports initial commercialization for both Reproxalap and ADX-2191. And I hope the answers to the prior questions have given you a sense of how we’re approaching those launches.

Bruce Greenberg: Yeah. And I would just add that…

Unidentified Analyst: Thank you.

Bruce Greenberg: …forecast is conservative and does not include any revenue nor does it include expect — any revenue from a license arrangement.

Unidentified Analyst: Terrific. Thank you.

Todd Brady: Thank you, Sean.

Operator: Thank you. Our next question is from Tom Shrader from BTIG. Tom, please go ahead. Your line is open.