Lisata Therapeutics, Inc. (NASDAQ:LSTA) Q3 2023 Earnings Call Transcript

Brian Dolliver: Right. And just looking at your spending guidance and the — which honestly looks pretty level over the course of the runway period, how sensitive would that be to the ebb and flow of enrollment in your trials? Because you have ASCEND wrapping up sooner than expected. It’s probably one of your larger trials at this point. So how should we think about the correlation between those two things from here?

Dr. David Mazzo: Well, like all trials, spending is correlated. The large — separate startup at the beginning and closed out at the end, the steady-state costs are per patient costs. So as you enroll, you incur expense. And then when you stop enrolling, you stopped those types of expenses. So — but we also have to recognize that we have organized these trials, almost all of our trials, but in essence specifically to be done, first of all, in Australia, where the costs generally are lower than they might be in the United States and where we get about 48% of all R&D dollars spent rebated back to us at cash at the end of the year. And also, we are essentially co-funding this trial, if you will. I mean we’re providing the maximum amount of funding, but the number of the standard of cares from the hospitals are being funded by those hospitals.

So there will be a reduction in expenditure relative to ASCEND once full enrollment is completed, but it may not be of the same magnitude that one might expect for a trial being completely funded by a sponsor here in the United States. But we still see a reduction in cost associated with that.

Brian Dolliver: Got it. And I’m assuming those rebates would show up as a contra to the expense line and opposed to the top — coming in on the top line, is that right?

Dr. David Mazzo: I’ll ask our Head of Finance. James, what’s the accounting on the rebate?

James Nisco: Yes, that’s correct. We do have for qualifying research and development activities in Australia, we are eligible to receive a refundable tax incentive between 43.5% up to 48.5%. So that does largely offset, let’s say, half of the expenses for the ASCEND study in Australia.

Dr. David Mazzo: And is that accounted for as a reduction in expense or as revenue?

James Nisco: That is accounted for as a reduction in expense. So that would be a reduction to the R&D expense. So it’s incorporated therein.

Operator: And your next question comes from the line of Pete Enderlin of MAZ Partners.

Pete Enderlin: My first question is a follow-up of earlier one about valuation of the stock and that is since LSTA1 seems to enhance the efficacy of a wide variety of oncology drugs and a variety of different modalities as well, the question is, have you guys experienced any increase in inbound inquiries from bigger pharmas that are interested in collaborating with you?

Dr. David Mazzo: And thanks for the question. It actually gives me a chance to talk a bit about the business development activities. The simple answer to your question is, yes. And I mentioned earlier, the confirmation of a lot of those potential deals is going to be based very, very much so on the delivery of the data that will come out over the course of these years. I think all of these companies have products that do well by a variety of different definitions, but could clearly do better and there’s the implication so far with the data that’s been generated to-date that LSTA1 can allow them all to do better. And that should lead us to a number of possibilities for either exclusive or nonexclusive deals, both on the R&D and the commercial side with a lot of players in the oncology world or just simply the ability to market list to one more broadly and have it utilized more broadly in the market when that time comes.

But yes, we’ve had quite a lot of interest shown and I think an expectation that that interest will continue to increase as data is generated.