Welcome to the Lisata Therapeutics First Quarter 2024 Financial Results and Business Update Conference Call. [Operator Instructions] Please be advised that today's conference is being recorded. I would now like to hand the conference over to our first speaker today, John Menditto, Vice President of Investor Relations and Corporate Communications. Please go ahead.

Thank you, operator, and good afternoon, everyone. Welcome to Lisata's First Quarter 2024 Conference Call to discuss our financial results and to provide a business update. Joining me today from our management team are Dr. David Mazzo, President and Chief Executive Officer; and Dr. Kristen Buck, Executive Vice President of Research and Development and Chief Medical Officer; and James Nisco, Chief Accounting Officer. Shortly before this call press release announcing our first quarter 2024 financial results, which is available under the Investors and News section of the company website, along with the webcast replay of this call. If you have not received this news release or would like to be added to the company's e-mail distribution list, please e-mail me at jmenditto@lisata.com. Before we begin, I remind you that comments made by management during this conference call will contain forward-looking statements that involve risks and uncertainties regarding the operations and future results of Lisata. I encourage you to review the company's filings with the Securities and Exchange Commission, including, without limitation, its forms 10-Q, 8-K and 10-K which identify specific risk factors that may cause actual results or events to differ materially from those described in the forward-looking statements. Furthermore, the content of this conference call contains time-sensitive information that is accurate only as of the date of this live broadcast, Thursday, May 9, 2024. Lisata Therapeutics undertakes no obligations to revise or update any statements to reflect events or circumstances after the date of this conference call. With that, I will now turn the call over to Dr. Mazzo. Dave?

Thank you, John, and good afternoon, everyone. I'm delighted to be with you today to provide an overview of recent business highlights, discuss our first quarter 2024 financial results and give an update on the progress of our various development programs. Building on the momentum of 2023, Lisata is off to a very strong start in 2024. We continue to make notable progress developing our lead product candidate, certepetide, formerly known as LSTA1 in combination with a variety of anticancer agents of different modalities as a treatment for multiple solid tumor cancers. As we have previously reported, encouraging preclinical data as well as early clinical data in humans continue to support our belief that certepetide has the potential to become an integral part of a revised standard of care treatment approach for many challenging solid tumors. Dr. Kristen Buck, our Executive Vice President of Research and Development and Chief Medical Officer, will provide a detailed update of our ongoing and planned clinical programs following the financial results review. But before getting to the numbers, I want to mention the achievement of another important milestone for Lisata. Certepetide spelled c-e-r-t-e-p-e-t-i-d-e is the official international nonproprietary name, or INN, United States Adopted Name was USAN, and Australian approved name or AAN, now formerly assigned to LSTA1. INN, USAN and AAN names are also referred to as generic substance names for pharmaceutical products. Obtaining one of these names is part of the commercial development of a drug and represents an important step along the path to commercialization. Going forward, we will systematically use the name certepetide when referring to our product rather than the internal code of LSTA1 to emphasize the progress being made toward product registration. With that, I now will turn the call over to James Nisco, our Senior Vice President of Finance and Treasury and Chief Accounting Officer. James?

Thanks, Dave. Good afternoon, all. I'm pleased to join you today to present a summary of our first quarter 2024 financial results. Starting with operating expenses. For the 3 months ended March 31, 2024, operating expenses totaled $6.6 million compared to $6.8 million for the 3 months ended March 31, 2023, representing a decrease of $0.2 million or 3.6%. Research and development expenses were approximately $3.2 million for the 3 months ended March 31, 2024, compared to $3.2 million for the 3 months ended March 31, 2023, representing an essentially unchanged spend. The minor increase of $62,000 or 2% was primarily due to an increase in expenses associated with our enrollment activities in the current year for our certepetide Phase 2a proof-of-concept bolster trial partially offset by a reduction in expenses associated with the Phase 2b ASCEND trial, which completed enrollment in the prior year. General and administrative expenses were approximately $3.4 million for the 3 months ended March 31, 2024, compared to $3.7 million for the 3 months ended March 31, 2023, representing a decrease of $0.3 million or 8.3%. This was primarily due to a decrease in staffing costs associated with the elimination of the Chief Business Officer position on May 1, 2023, a reduction in option assumption equity expense in connection with the Cend merger, a decrease in directors and officers insurance premiums and a reduction in spend on consulting and legal fees, partially offset by one-off settlement-related costs. Overall, net losses were $5.4 million for the 3 months ended March 31, 2024, compared to $6.2 million for the 3 months ended March 31, 2023. Turning now to our balance sheet and cash flow. As of March 31, 2024, Lisata had cash, cash equivalents and marketable securities of approximately $43.3 million. Based on our current business and development plans, the company believes that its available capital will fund operations into early 2026, encompassing anticipated data milestones from all its ongoing and currently planned clinical trials. This completes my financial overview, and I will now turn the call over to our Chief Medical Officer, Dr. Kristen Buck for the review of our clinical development pipeline. Kristen?

Thanks, James, and good afternoon, everyone. Lisata's development programs are based on sound scientific rationale from a vast body of published preclinical and early clinical works. These works include those, which led to Dr. Erkki Ruoslahti being awarded the Lasker prize for the fundamental discoveries that spawned our CendR platform technology. A product of the CendR platform certepetide is designed to address major impediments to the successful treatment of advanced solid tumors. This is especially relevant in an environment of increasing cancer prevalence and growing pharmacoeconomic pressures. Our clinical studies have been rigorously designed with the end in mind that is product registration and they're optimized to generate clinically meaningful unambiguous data. As such, unlike many similarly phased studies, our studies are placebo-controlled, appropriately sized and employ primary endpoints that are preferred by regulatory authorities in support of pivotal trials. Further, our trials evaluate certepetide in combination with current standards of care to allow for clear discernment of treatment effect and to fit with current treatment practices at clinical sites. These strategic design choices are not always the least expensive approach, but they do afford us the most scientifically rigorous methodology by which to generate clinically meaningful data as efficiently and rapidly as possible. This is in keeping with our diluent mantra do the last experiment first to avoid the time and capital consumption on work that could become unnecessary. We have also devised and implemented a regulatory strategy that optimizes certepetide's regulatory review and future commercialization. This strategy includes obtaining special regulatory designations, priority reviews and accelerated approvals. I will speak more to the company's strategy in a moment. But as you can imagine, the aforementioned opportunities underpin why we are so excited about the initial top line results that we'll report at the end of the year from…

Can you hear me...

Yes.

Okay. I was having some technical difficulties. I apologize. Thank you, Kristen. We appreciate that comprehensive overview. Even with multiple data readouts over the next 18 months, as outlined by Kristen, we see the ASCEND initial top line data as being seminal to the certepetide development program into our company. These results will be instrumental in allowing us to consummate business transactions associated with the product and in defining our future capital needs. That said, we remain committed to advancing all of our certepetide development programs across a variety of solid tumor indications in order to fully exploit both the medical and commercial promise of certepetide. Now that we have entered the 6-month window to data, our excitement and the attention we are receiving from prospective partners, licensors and investors are increasing daily, and we look forward to sharing further details on our progress throughout the year. And with that overview, operator, we are ready to take questions.

[Operator Instructions] Our first question comes from Joseph Pantginis from HC Wainwright.

This is Sara on for Joe. Just wanted to ask, I guess, more much bit early, but for certepetide and GBM, I was wondering when we could -- or when you're gauging to reach that target enrollment completion and if you're planning to kind of give a first look at any initial data cuts along the way? Or are you waiting to reach that 30-patient enrollment to give a first look at data?

Thanks, I appreciate the question. I'm going to ask Kristen to jump in here in a minute on timing. But as it relates to taking a first look at data, this trial like many of our other trials is blinded and does not have in it a provision for an early breaking of the blind for an early look. So we'll have to wait until all 40 patients are actually enrolled and reached their end points. In terms of enrollment, Kristen can give you a better idea of what we're seeing right now, especially given that the trial had a safety period, a safety observation period built in, which we're just coming to an end of and which will allow now for us to actually enroll patients at a much higher pace. So this is for the GBM trial in Estonia and Latvia.

Thanks, Sara, for the question. We have currently 3 subjects enrolled out of 30. And the last subject, I would say the first 3 subjects require a 30-day observation for safety. Our last subject of the 3 is 2 weeks into their 30-day safety running. To date, we've not seen any safety concerns. And therefore, within 2 or 3 weeks, we anticipate the rest of the enrollment to pick up.

Thank you one question -- our next question comes from Will Hidell from Brookline Capital Markets.

I had a quick question regarding the trial with Qilu. Why would they need 18 months...

We can hear you. Go ahead, Will.

Can you hear me now..

Well, if you could mute yourself.

No, we can hear him, operator.

So regarding the trial with Qilu, why would you need 18 months to enroll the trial given your experience with ASCEND and I guess, the tendency for the Chinese oncology trials to enroll quickly.

Well, thanks, Well, I appreciate the question. To be clear, the Qilu trials are run exclusively by Qilu. All the operations and execution are completely within their purview. We do speak to them about strategy as part of the joint steering committee, but execution is completely up to them within China. I'm not sure that they will need 18 months, but that's what they had communicated publicly that that's their projection at the moment, and hopefully, they'll go faster.

It appears we're having technical difficulties with our operator to take the next question.

If someone has another question, can you just speak up, John, are you there? Can you see if we can get any response and to figure out what's going on technically?

This is Pete Enderlin. Can you hear me?

Go ahead, Pete. Yes.

Okay, good. Well, the first question is just a technical financial question. You filed a $150 million shelf. I assume that's just to replace one that recently expired. But do you have anything further to say about the use of that other than obviously providing financial flexibility.

You answered your own question. That's really a housekeeping matter. Our previous shelf was expiring, and we always need to keep a shelf on trial in order to be able to take advantage of ancing and other opportunities as they might arise. So right now, it's just financing housekeeping, if you will.

Okay. And then more substantive question. For example, the BOLSTER trial is in the U.S., Europe, Canada, Australia and you have several trials that are in different venues around the world. So the question is, do those all operate, let's say, the one for the BOLSTER trial under U.S. FDA protocol or the different standards in every country that you do them? And if that's true, why do you bother having all these different things to work under, which would make it more expensive and more complicated.

All right. So thanks, Pete. I appreciate the question. So first of all, whenever we do -- and frankly, I think this is true across the entire pharmaceutical industry, whenever anyone does a trial with international sites, they all work under the same protocol otherwise, it would be different trials. So everybody is working under the same protocol, no matter where they're enrolling. And the reason that we enroll internationally for certain studies is to be able to acquire patients more readily and to get a broader demographic population, which is typically something that's required in later-stage studies. In case of our BOLSTER trial, actually BOLSTER is running in the United States alone right now. We've enrolled cholangiocarcinoma solely in the United States, and we plan to do the second line study solely in the United States. ASCEND is running in Australia, New Zealand. And the GBM trial is running in Estonia and Latvia, and some of our other trials are looking at sites around the world as well. But it's mostly again, to take advantage of patient prevalence and sometimes to actually get lower costs rather than higher cost as you suggested.

For example, with that trial in Estonia and Latvia, then that would be -- you'd basically be talking to our FDA about that, even though it's being done over there.

Yes. At the European Union, the EMA as well.

Okay. But I'm not clear on who's actually setting the rules on what you have to do to run the trial. Is it the U.S. or Europe?

Well, the protocol is set by us, the rules governing good clinical practice are actually set by the International Conference on Harmonization, to which the FDA, the EMA, the Japanese regulatory authorities and myriad other regulatory authorities are signatories. So basically, there's a consistent international set of rules for conducting clinical trials, and that's what we will follow.

[Operator Instructions] Our next question comes from Steve Brozak from WBB Securities.

I'm going to go back on the finance side. You've obviously focused on making sure that you have funding for as long as possible through 2026. And you just mentioned I think Kristen just mentioned the potential for getting a voucher after a successful completion of the trialing. But there's one question I've got for you because you've got all these patients you're treating and they are very, very ill patients. At the end of the day, you're going to be dealing with patients who have undergone quite a bit of therapeutic treatment at a very, very high cost. Can you give us any sense -- I'm not asking you to go out there and tell you what certepetide is going to cost or be charged, but what are these patients? What is the system currently paying for -- and then it can be an order of magnitude paying for these patients who are currently being treated standard of care in a ballpark, please. And just in the United States because, obviously, different countries have different cost parameters. What are your thoughts there? And I've got one follow-up afterwards, please.

All right. So for -- well, thanks for the question, Steve. I appreciate you being on. In the United States and in fact, in many other countries around the world, the current standard of care for pancreatic cancer is chemotherapy. And it falls pretty evenly distributed between 2 regimens. One is a combination of Gemcitabine nab-paclitaxel. Nab-paclitaxel is also known as Abraxane. And the other is FOLFIRINOX. And these are products -- these chemotherapeutics are -- they're actually generic right now, and they're covered by insurance generally for all these people. So I don't know the exact cost off the top of my head. But the fact is that the introduction of new therapies like immunotherapies, which are much more costly, is being readily absorbed by these patients because they have such dire circumstances and they're seriously looking for other things. Typical, just to give you a ballpark, a typical regimen of gemcitabine nab-paclitaxel is around $60,000. So that gives you some sense. And our product is, as Kristen, I think, so eloquently described is simply a small cyclic peptide. It's not as inexpensive to make as a small chemical entity, but it's made by solid-state chemistry that's pretty well standardized these days. And so it's expected to have a cost that will be very reasonable, especially in comparison to the cost of immunotherapies and some of the CAR-T cellular therapies, which can cost hundreds of thousands dollars or even millions of dollars. I hope that gives you a better idea.

That's exactly what I was looking for. You touched on the critical matter of all these immunotherapies that are out there and that are quite expensive and that are, frankly, not seeing the results that you're looking for. So if you're looking at that and because, unfortunately, you're seeing these patients who are so late stage, especially in pancreatic cancer. I would imagine that this would be something we're looking at for positive results, but this would be looked at as something that is providing for a change of standard of care going forward. So going back to not just the benefit of a voucher, you're looking at a situation where you would actually be -- you would actually be providing a quality care that is not seen today. Is that an accurate statement and please fill in anything else, and I'll hop back in the queue.

No, Steve, I think that's actually -- that's it. In fact, what I think we see in some of our remarks and certainly in our press release, we expect that this is -- that the addition of certepetide or its final approval will actually change the paradigm for standard of care, adding certepetide to current standards of care, which can evolve should improve them regardless of what they are based on the mechanism of action that Kristen described. And so we really do see this as a paradigm changer for the treatment of solid tumor cancers and expect that it will have very broad applicability as a result.

Thank you all on me for our next question. Our next question comes from Robert Sassoon from Water Tower Research.

I was just wondering whether in the early -- the studies that you've got a number of trials going on whether you've seen any variation in performance of certepetide with respect to the various conditions that you're targeting.

Kristen, do you want to comment on that or please?

Sure. We haven't -- as Dave and I have previously stated, safety has not been a problem. The drug typically reflects the combination with which it's given the anticancer agent. Anecdotally, I mean, our trials are blinded, so I can't really speak to what is truly happening. But I have received several calls from our investigators off hours saying they are so encouraged by our drug when given to cholangiocarcinoma patients. Just as an anecdote, one told me this patient had 2 weeks to live and 3 months later, they're out skiing. So I can't answer whether that's on our drug or not, but that's probably where we've heard the most anecdotal data that they're very enthusiastic.

Okay. And just one more question. Do you -- I mean, is there any anticipation of getting some milestone payments down the road? Do you have a sort of potential timeline for that?

Well, we have an activity line and the timeline is dependent on Qilu's execution. But we do have milestone payments that will be paid for completion of activities, such as technology transfer for manufacturing and for initiating Phase 3 and ultimately, for registration. Now they've just started Phase 2 as we announced a couple of weeks ago, and we imagine it will take a while for them to get through Phase 2 and to get to Phase 3. But there is always the possibility that the results in China will be so good that they could convince the Chinese regulatory authorities that this Phase 2 trial could become the basis of a provisional application. And I think under those circumstances, that would qualify for the pivotal trial, and we could get a milestone along those lines as well. So I can't really speak to timing. But certainly, over the course of the next several years, we would expect to collect some milestones from achievement.

[Operator Instructions] Our next question comes from Robert LeBoyer from Noble Capital Markets.

I have -- well, first, congratulations on all the progress. And in Dr. Buck's summary, I heard it was a very good comprehensive summary. But one of the things that I didn't catch was whether the BOLSTER trial will be announcing data in '25 or if there were any timelines for BOLSTER or CENDIFOX. I caught the expected completion by the end of the year, but I didn't hear anything about the expected data release.

Thanks, Robert. Appreciate the question. Thanks for being on the call as well. The -- all of our trials, as Kristen pointed out, are designed to reach data before our current cash outdate. So we're currently funded through early '26 and everything is designed at this point in order to reach data before that. So I would expect that with a BOLSTER trial current target of approximately end of year for completion of enrollment, we should certainly be announcing data before the end of the year next year. And as Kristen pointed out, we could be completing enrollment in BOLSTER, a lot sooner than that, which would just bring forward the data announcement to 2025.

I'm showing no further questions. This concludes the question-and-answer session. I will now turn it back over to Dr. Mazzo for closing remarks.

Thank you, operator. And again, thank you all for participating in today's call. We look forward to speaking with you again during our next quarterly conference call and to continuing to provide updates on our achievements and progress. We remain grateful for your continued interest and support. Stay well, and have a good evening.

Thank you for your participation in today's conference. This does conclude the program. You may now disconnect.