GeoVax Labs, Inc. (NASDAQ:GOVX) Q4 2022 Earnings Call Transcript

We’ve not been able to enroll that study as quickly as we had anticipated at the City of Hope National Medical Center where it was begun. And for that reason, we’ve begun enlisting support of multiple other academic medical centers. And by summer time, we should have a handful of those lined up in enrolling patients. So I wouldn’t anticipate any significant readouts of that for my best guess, a year, something like that. Just because these patients — it’s hard to find patients that meet the eligibility criteria for this trial.

Jason Kolbert: Okay. Fair enough. And my last question is really understanding the importance of the NBA manufacturing process. What I’m thinking here is that what you’re saying is, in the event that there is another pandemic, the ability to be able to make a vaccine at scale, high capacity, high yield quickly becomes critical obviously, you’re differentiated from an mRNA process, which is a pretty rapid process too, but you’re making the point that you’re getting away egg based vaccine technology is something in the past and you’ve now kind of got this critical piece in place. Is that understanding correct, I would add to that.

Mark Newman: Yeah. It’s Mark Newman. Let me comment on that one. Sure. Yeah, that is the goal here. The mRNA is a platform, as you mentioned, where you can really enables you to do a rapid response. So there’s a difference between a response and building a vaccine capability. So the cell line production gives us large scale, but it’s also the idea is to get back to kind of the normal world of vaccines where childhood vaccines are given at a young age and you hope never to get sick rest of your life type of thing. And that’s what we’re looking at for our products. So larger scale need — larger scale manufacturing would be needed to meet that type distribution. So it’s — we’re focused on COVID, so you’re always being compared to the mRNA vaccine groups, but we’re actually targeting that field totally differently.

So it’s — that’s the issue. It’s kind of — we can be small scale and certainly address with the current technology, smaller niche types of patient populations, but really expand it which is what’s in our plans that will fit into the cell production based systems.

Jason Kolbert: Yeah. Thank you. That really clears it up for me a lot. Congratulations on all the progress. I hope David as well. Thank you.

Operator: Our next question comes from Vernon Bernardino with H. C. Wainwright. Please state your question.

Vernon Bernardino: Hi. Thanks for taking my question. Most of them have already been asked and answered. But just wanted to follow-up on Jason’s question. Regarding Gedeptin, now the kind of efficacy that we might expect from the Phase 1/2, you mentioned that eight patients have been enrolled and perhaps expect some data at the end of summer. But what kind of data would that be? Would that be just data in which you confirm that Gedeptin shrink tumors or is there some of the kind of efficacy data you expect to announce?

Kelly McKee: Well, I mean, we are measuring I mean, our end point measures include sort of — we’ve graded these tumors under RECIST 1.1 and we will be taking tumor measurements. We’ll be looking at not only sort of quantitative impact on injected tumors, but the potential effect on just distant tumors that were not injected. And it’s as much to give us a sense for or some confidence in that, what we’re doing is actually benefiting patients in a meaningful way just in terms of improving somewhat their quality of life. But also sort of giving us some guidance with regard to direction for follow on studies. There’s no doubt that we’re going to have to add additional patients to the 10 that we will have at the end of this trial.