Applied DNA Sciences, Inc. (NASDAQ:APDN) Q1 2023 Earnings Call Transcript

Jason McCarthy: Okay. Just jumping over to the canine linear immune therapy opportunity. You had said you’re moving soon €“ or relatively soon, I think, into small animal study to finalize your formulation. Can you just help us understand a little bit about, one, the time to get there? And two, what is the development path for canine immune therapy? Is one small trial enough? Or do you need to go through several phases like you would in human development?

James Hayward: Sure. Clay, if you’d like to speak to the issue of the time frame and the size of the trial necessary to get preliminary approval from USDA? But it’s a simple trial, and it’s really life extension. When it comes to older dogs, many of them get lymphoma. And their prognosis typically is measured in months. And so I think impacting that prognosis with a longer lifetime will be the hallmark of success for the therapy.

Clay Shorrock: Thanks, Jim. Hey, Jason. Yes, so it’s going through USDA, right? So it’s not going through FDA. So it’s veterinary biologics. Most of the data points we have for trial size and trial time are coming out of the onco drugs going through FDA, right, so your chemotherapy. Those getting approval are quite small trial sizes, well under 50, in terms of big canines enrolled. And as Jim said, the endpoints are not that at high. It’s really just increasing the life expectancy. What we’ve seen from USDA for conditional approval, right? So we’re not going for full approval. Our goal here is conditional approval. We’ve seen trial sizes the smallest, probably 20. And again, that end point is pretty permissive. So we think it’s a very reachable endpoint with the product that we’re looking to develop. And then once we get that conditional approval, we would attempt to off license.

Jason McCarthy: Who on the larger pharma side has the most attractive veterinary arms in their portfolio that you might look towards for a potential partnering for something like this? As far Pfizer was and then they weren’t, I’m not sure if they’re still in the vet space?

Clay Shorrock: Yes. I mean, Jim, I don’t know how you feel, but right now, the plan is to really target the next-generation chemotherapy drug companies in the veterinary space, right? There’s been a couple of new approvals in the chemo space for canine lymphoma and this therapy act as a companion therapy to those. So it’s the logical choice for us is to run those in our trial and then seek out them as a companion therapy.

James Hayward: Yes. That’s exactly that this is a companion approach to increase the efficacy of chemotherapy for which there are, I believe, right now, two in the market.

Jason McCarthy: Okay. Great. Thank you. I’ll jump back in the queue.

James Hayward: Okay. Thanks.

Operator: The next question is from Yi Chen with H.C. Wainwright. Please go ahead.

Yi Chen: Thank you for taking my question. Could you comment on when the current contract with the big customer for COVID-19 test end? And whether the customer will renew that contract depending on the government’s official emergency status for COVID? Thank you.

James Hayward: Sure. I can tell you that the customer has given us no commentary about their plans after the summer. But I can tell you that they have been remarkably conservative in terms of the care of their population. And they’ve shown their willingness to go to great ends to do so.

Yi Chen: Okay. So with respect to PGx testing, so you mentioned that you will file your validation package with New York State Department of Health. How much revenue should we expect to see later this fiscal year coming from PGx testing panel?

James Hayward: Yes. So PGx testing has the capacity to roughly replace our COVID testing one-to-one. That’s a function of what capacity we build to. But increasing scale is relatively simple. It’s just a matter of more equipment.