Aethlon Medical, Inc. (NASDAQ:AEMD) Q4 2023 Earnings Call Transcript

Marla Marin: Okay. thanks.

Steven LaRosa: So we don’t see currently. Yes.

Marla Marin: Thank you.

Operator: Our next question comes from Anthony Vendetti with Maxim Group. Please go ahead.

Jeremy Pearlman: Hi, good afternoon. This is actually Jeremy Pearlman on the line for Anthony. First, I actually wanted to thank you for participating in our Maxim Healthcare Conference last week. I think it was really great. So a couple of questions from us. First one relating to the oncology trial. If there’s any more information you can provide regarding a time line? I know you said that they are – that NAMSA is performing some activities currently like site identification, but what is it – do you have any more clarity on the time frame for this trial when you think it could start enrolling patients?

Steven LaRosa: Right. So as you’d imagine, there’s a number of activation steps to actually initiating a clinical trial. Some of the most important are actually identifying sites that are interested in having them go through the site qualification visits, and we’re actually involved in those right now. The other big step, just so you understand the process in Australia, since it’s somewhat opposite of what occurs in the United States, in Australia, the sites submit for approval to do the trial from their hospital’s Ethics Board and then notify the regulatory agency. So it’s important in Australia that you have all the documents in order to maximize the chance that the Ethics Board is going to approve your study. So we’re actually getting all those documents in their best shape for submission. So we’re doing that. The hope is that we — and the goal, I should say, is to have this process go forward such that we could enroll someone by the end of the calendar year.

Jeremy Pearlman: Okay. Great. So end of 2023. Okay, great. That’s — and then just jumping to this new organ transplantation market you’re investigating. So how would you compare that opportunity to the oncology, which one now do you view as your nearest term potential commercial opportunity?

Steven LaRosa: Well, the – I’d say in fairness, the oncology where headed towards actually enrolling patients in a clinical trial. For the transplantation indication, we do have a number of translational studies and likely preclinical safety studies that would have to be done in anticipation of a clinical trial. So now these translational studies can be done very quickly because they are their laboratory studies. So they can go as fast as we go. But the – it’s likely that a patient would be enrolled in an oncology trial before the transplantation trials.

Jim Frakes: This is Jim, Jeremy. Also, there will be several steps in an oncology trial. We have the initial safety trial, and then we tweak it and have a larger efficacy trial. I am not sure what – how many steps we’d need to take with the organ transplantation project. All the preliminary work that Steve was just mentioning is on organs of dead people. So the FDA would not be involved on that. They would be involved when the organs are actually transplanted into patients, of course. So we can do a lot of work without the FDA’s help. And then how many – whether we need more than one? Do we need a safety trial and an efficacy trial? I do not know. It’s unclear. But the path to market, while we’re starting later than the cancer trial, who knows, it could be potentially faster to market.