Lisata Therapeutics Inc (NASDAQ:LSTA) CEO David Mazzo joined Proactive to talk about the latest updates on its clinical trials and its third quarter financial performance.
Mazzo highlighted advancements in Lisata's pancreatic cancer program, specifically the ASCEND trial, which is expected to yield important data soon.
He noted that the data from this trial’s first cohort would be presented at the upcoming American Society of Clinical Oncology (ASCO) GI Cancers Symposium.
Proactive: You're out with your quarterly results and a business update this week. It looks like you continue to make significant enhancements across your clinical portfolio over the period.
David Mazzo: That is correct. And thank you again for having us. It's a pleasure to be here. We are making significant advancements, and I think it's notable, given that we remain a small team but have impeccable execution. To summarize across our portfolio, most people know we’re awaiting what will be considered seminal data for our pancreatic cancer program from the Phase 2b ASCEND trial. We expect topline data to be available in the coming month or so, which should be very interesting. The trial sponsor, our partner, the Australasian Gastro-Intestinal Testing Group (AGITG) Clinical Trials Organization in Australia, has had an abstract with preliminary topline data from Cohort A accepted for presentation at the ASCO GI Symposium in January in San Francisco. Cohort B data is maturing as we speak.
We’ve also made great progress in our cholangiocarcinoma trials. Our BOLSTER trial for first-line cholangiocarcinoma enrolled at a very rapid rate. We’ve also initiated a second-line cholangiocarcinoma trial, which is now enrolling at a planned rate, an important milestone for us. Additionally, our collaboration with WARPNINE Foundation in Australia on the iLSTA trial, which combines cytotoxic and immunotherapy in advanced pancreatic cancer, is close to finishing enrollment. This trial will also be featured in an ASCO GI abstract.
You also ended the quarter with almost $36 million in cash and cash equivalents—a strong cash runway as you progress these trials, David?
That is absolutely correct. We have a much stronger cash runway than many other small companies. We anticipate cash flow through early 2026, enabling us to reach all planned trial milestones. We are, however, frustrated that our valuation remains below our cash value, which we believe undervalues the strong fundamentals and operational excellence we bring, particularly as we conserve and steward capital effectively.
You mentioned a couple of collaborations earlier. This week, you announced one with Valo Therapeutics in Finland and another with the University of Cincinnati. Could you take us through the rationale behind these collaborations?
Certainly. Both collaborations expand the applicability of certepetide. With Valo Therapeutics, we’re testing a combination therapy involving their oncolytic virus platform and certepetide for metastatic melanoma. Their validated mouse model for melanoma has demonstrated efficacy, and our goal is to generate data sufficient to move into human testing. Our partnership with the University of Cincinnati is our first step outside oncology, targeting endometriosis—a highly unmet medical need affecting about 90 million women globally. Endometriotic tissue, much like tumors, is antigenic and expresses receptors needed for certepetide's mechanism. We hope this will generate pre-clinical data supporting eventual human testing in this area.
What other news flow should your investors be looking out for?
Generally, as I mentioned earlier, we’re working toward additional commercial collaborations outside oncology. You can expect new partnerships across both oncology and non-oncology areas in the coming months. Our corporate presentation on our website details expected data and execution milestones over the next 12 to 15 months. We are entering a data-rich period, so there will be plenty of updates.
Quotes have been lightly edited for clarity and style