Lisata Therapeutics, Inc. (NASDAQ:LSTA) Q2 2023 Earnings Call Transcript

Dr. David Mazzo: Well, in general, you would expect that the medical, scientific results, efficacy and safety should drive some level of consistency of evaluation and decision in regulatory authorities around the world. But in reality, each regulatory authority, whether it be the European Medicines Association, the Food Drug Administration, the TGA in Australia, the Chinese authorities, MHLW in Japan, whatever, they tend to take their own decisions based upon situations which involve, of course, safety and efficacy. But to a certain extent, they have to take into account pharmacoeconomic and even sometimes political considerations within their countries. So we would hope that there would be some level of consistency, and we will, of course, explore the opportunity for conditional approvals in all the major registration areas of the world should that opportunity arise.

Pete Enderlin: Does that — I mean, how many different agencies do you contemplate approaching initially for that kind of program?

Dr. David Mazzo: At least, well, we’re going to — we’ll approach the Australian agency, of course, we’ll approach the FDA and most likely eventually the EMA.

Pete Enderlin: And China, I guess, too, right?

Dr. David Mazzo: And — China is being handled by our licensee, Qilu. So they have their own development program, which does include the accelerated path that they call the innovation pathway contemplation. So I think they’re pursuing that to the extent that they can as well.

Pete Enderlin: Okay, thank you very much for the information.

Dr. David Mazzo: I can clarify right now, the current transfer agreement does not include specifics of royalty. It’s just our ownership in the Company that would provide us a financial upside should the product be successful.

Operator: And our next question will come from Kemp Dolliver with Brookline Capital Markets.

Kemp Dolliver: Great. I have two or three questions. Quickly, beyond the elimination of the Chief Business Officer position, were there other actions of consequence taken to reduce expenses?

Dr. David Mazzo: Yes, we made the conscious decision to streamline our efforts in R&D to basically D. And so anything that was preclinical, exploratory or fundamental, supporting what was eliminated. We also refined Kristen’s clinical operations organization to better suit the execution of the trials that we are doing now in comparison to the trials that we might have been doing several years ago.

Kemp Dolliver: Great. And there was not any mention of the status of the MORPHEUS program with Roche. Do you have any incremental insight into the status of the program on their front?

Dr. David Mazzo: Really nothing new since our last quarterly update at this point, the program remains on hold pending internal decisions that Roche needs to take. Based on, I think, their overall development strategy with atezolizumab. So we’re just on standby waiting.

Kemp Dolliver: Okay. Great. And then my last call — question relates to cisplatin. And it’s — if it had the impact on the BOLSTER trial. But I think cisplatin is also being used in the ASCEND trial that seems to be moving on. Just can you talk about whether we should have any concerns about any of your other trials that would use chemotherapies? Or is it really just limited to BOLSTER at this point?

Dr. David Mazzo: I believe we can say, first of all, with confidence that cisplatin is not part of the standard of care that’s being tested in ASCEND. That’s a combination of gemcitabine and nab-paclitaxel. So the cisplatin shortage is not impacting ASCEND. I believe at this point, really, it’s just the cholangiocarcinoma arm of Bolster that is the major impact. Kristen, is there any other thing that I’m forgetting as it relates to the use of cisplatin in any of our trials?