Welcome to the Lisata Therapeutics Second Quarter 2023 Financial Results and Business Update Conference Call. Currently, all participants are in a listen-only mode. Following managements' prepared remarks, we will hold a question-and-answer session. [Operator Instructions] As a reminder, the call is being recorded today, Tuesday, August 15, 2023. I will now turn the call over to John Menditto, Vice President of Investor Relations and Corporate Communications at Lisata. Please go ahead, sir.

Thank you, operator, and good morning, everyone. Welcome to Lisata's Second Quarter 2023 Conference Call to discuss our financial results and the opportunity to provide a business update. Joining me today from our management team are Dr. David Mazzo, President and Chief Executive Officer; Dr. Kristen Buck, Executive Vice President of Research & Development and Chief Medical Officer; and James Nisco, Vice President of Finance and Treasury. Yesterday, Monday, August 14, we issued a press release aftermarket trading closed announcing our second quarter 2023 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 the news release or if you'd 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, Tuesday, August 15, 2023. Lisata undertakes no obligation to revise or update any statements to reflect events or circumstances after the date of this conference call. With that, I'll now turn the call over to Dr. Mazzo. Dave?

Thank you, John, and good morning, everyone. Thank you for joining us today as we provide an overview of recent business highlights, discuss our second quarter 2023 financial results and give an update on the progress of our various development programs. I'm kicking off today's call with a heightened sense of excitement and optimism for the future of Lisata. During the second quarter, we continued the advancement of our clinical development programs for the treatment of advanced solid tumors. As those familiar with the Company know, Lisata is a clinical-stage pharmaceutical company focused on the development of a novel solid tumor targeting and penetration technology to improve the efficacy of anticancer drugs. Our development portfolio contains programs that are designed to bring significant therapeutic improvements in the treatment of solid tumors in a pharmacoeconomically attractive paradigm. LSTA1, our lead product candidate is the subject of multiple planned and ongoing clinical trials being conducted globally in a variety of solid tumor types and in combination with multiple anticancer agents of different modalities. Based on substantial preclinical and most importantly, early clinical data in humans, we believe that LSTA1 has the potential to become an integral part of a revised standard of care treatment regimen for many difficult-to-treat cancers. During this call, our Chief Medical Officer, Dr. Kristen Buck, will provide more specifics on our clinical programs following our review of financial results. However, before moving on to the financial and clinical overview, we are pleased to announce a significant milestone in the form of a technology transfer agreement of our tumor penetrating nanocomplex, or TPN, platform with Impilo Therapeutics, Inc., a recently formed company, led by David Slack, former Lisata Chief Business Officer. The TPN platform targets intracellular delivery of RNA-based drugs to prevent solid tumor growth. TPN is designed so that it not only binds to proteins overexpressed on the surface of human cancer cells but also passes through the membrane by way of a cell-penetrating peptide. Once inside the cells, the TPN is expected to release an RNA-based drug directed against the tumor. The noted technology transfer will place the TPN technology in the capable hands of the team with profound expertise in RNA-based therapeutics development, further enhancing its potential impact in the field. Under the terms of the technology transfer agreement upon closing Lisata will receive an equity stake in Impilo Therapeutics. Lisata will also receive a seat on Impilo's Board of Directors, but is not obliged to commit any capital or additional resources to the program's future development. With that, I now will turn the call over to James Nisco, our Vice President of Finance and Treasury, to review and provide commentary on our financial results. James?

Thanks, Dave. Good morning all. I'm pleased to join you today to present a summary of our second quarter 2023 financial results. Starting with operating expenses. Research & development expenses remained constant at approximately $3.2 million for the three months ended June 30, 2023, and three months ended June 30, 2022. The Expenses this quarter were primarily due to study start-up activities associated with the LSTA1 BOLSTER trial, enrollment activities for the LSTA1-ASCEND study and chemistry, manufacturing and control activities for LSTA1 to support all development activities. General and administrative expenses were approximately $3.7 million for the three months ended June 30, 2023, compared to $3.5 million for the three months ended June 30, 2022, representing an increase of $0.2 million or 6.5%. This was primarily due to severance costs associated with the elimination of the Chief Business Officer position on May 1, 2023, partially offset by non-recurring merger related costs in the prior year. Overall, net losses were $4 million for the three months ended June 30, 2023, and compared to $6.6 million for the three months ended June 30, 2022, a decrease of approximately 40%, primarily due to $2.2 million in non-dilutive funding received as an approved participant of the Technology Business Tax Certificate Transfer program sponsored by the New Jersey Economic Development Authority. Turning now to our balance sheet and cash flow. As of June 30, 2023, the Company had cash, cash equivalents and marketable securities of approximately $57.6 million. The Company is confident that its projected capital will fund its current proposed operations into the first quarter of 2026, encompassing anticipated data milestones from all its ongoing and 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?

Thank you, James, and good morning, everyone. As those that follow us know, Lisata's pipeline is built on a portfolio of proprietary and patented technology that is grounded in strong scientific rationale and a body of published preclinical and early clinical data. Our platform technology is designed to address major impediments to the successful treatment of advanced solid tumors in the context of increasing pharmacoeconomic pressures on the health care system. We appreciate the critical importance of generating meaningful clinical data to advance our platform technology, and I can assure you that our entire organization has this goal top of mind in everything we do. With that, I will now provide an overview of our lead product candidate, LSTA1, LSTA1, for the treatment of advanced solid tumors in combination with other anticancer agents. Despite advances in cancer therapy today, many solid tumors remain difficult to effectively treat. Cancers, such as pancreatic cancer, gastric cancers and other solid tumor cancers are surrounded by a dense fibrotic tissue known as the Stroma, which limit the access of most pharmacotherapies to the tumor. Many tumors also exhibit a hostile tumor microenvironment, or TME, which suppresses the patient's immune system and makes it less effective in fighting cancer. The combination of dense stroma on a hostile tumor microenvironment negatively impacts the ability of many cytotoxic agents and immunotherapies to effectively treat these cancers. This coupled with the fact that most anticancer therapies are not efficient in targeting only cancer tissue defines the major challenge of maximizing effectiveness and safety in the treatment of solid tumors. To combat this, Lisata's approach is to activate the C-end rule, or CendR system, a naturally occurring active transport system to selectively deliver anticancer drugs through the stroma and into the tumor. Lisata's lead product candidate, LSTA1 is an…

Thanks, Kristen. As we look back to the beginning of the year and even further to the status of development of LSTA1 in the clinic at the time of the formation of Lisata in September of 2022, it becomes immediately apparent that our team has made notable progress advancing this program according to the two pillars of our development strategy, rapid and focused development of LSTA1 in mPDAC and broad application of LSTA1 in combination with a variety of anticancer agents applied to a variety of solid tumor types. We have designed our studies to be scientifically and medically rigorous and to provide results expeditiously while also assuring that we are operating in a maximally capital-efficient manner. Now with more than two years of capital available on our balance sheet, we believe we are well placed to focus on the execution of our development plans and to achieve our goal of getting meaningful clinical data readouts as soon as possible. And with that overview, operator, we're now ready to take questions.

[Operator Instructions] We have a question from Joseph Pantginis with HCW.

Sara On for Joe. I was wondering, based on the brisk enrollment that you've seen for the ASCEND can you possibly gauge expectations where we could expect the potential data readout.

Thanks, Sara. I appreciate your question. Right now, the ASCEND trial protocol is very specific. It's a blinded trial, the two cohorts as Kristen described, and the current statistical analysis plan calls for a complete analysis and a data readout at the end of the trial. So based on current projections, let's just say, the second quarter 2024 to complete enrollment, we should expect a data readout sometime about a year to 18 months after that. I will say, however, we're looking at other means that might get us to some earlier data. And we'll be in a position to talk about those sometime during the fall. But of course, they do require agreement with our partners, AGITG and CTC in Australia, and we want to be sure that we don't compromise the integrity of the blinded study.

We have a question from Steve Brozak with WBB Securities.

Yes. Given the fact that the patient profiles that you're looking at are really, really seriously ill patients, what type of outcomes do you look at? Because you're looking at patients where the current standard of care can be very, very harmful, chemotoxins that are used on these patients. So how would you judge outcomes that would be, let's say, optimal or even things that would be nontraditional as far as what you expect? And I have one follow-up after that.

Thanks, Steve. I'll answer the question generally, and then I'll turn it to Kristen, who may be able to provide some additional specifics. But generally speaking, as you pointed out, let's use mPDAC as the example. Now under current standard of care, the median survival after diagnosis these days is still only around 9-or-so months and less than 10 or so percent of the people diagnosed survive out to five years. So it's a really devastating and lethal disease even with the current chemotherapy treatments. We're looking to substantially improve that, of course. And so ultimately, in cancer, while quality of life and progression-free survival are important endpoints, what we're looking to do ultimately is to extend overall survival in a meaningful way. And now I'll turn to Kristen to see if she'd like to provide some additional color.

Thanks, Steve. I would only add a few caveats. We are definitely looking to improve overall survival as the patient populations which we're studying have horrible diagnosis and prognosis. So while overall survival will predict their outcome, we're looking at progression-free survival, how long the patient stays well before their tumor progresses. And the most important part is not enhancing the toxic side effects that these drugs have because we're targeting the tumors instead of over blasting the patient with cytotoxic, we're trying to target the tumor, so the cytotoxic and immunotherapies are specifically going into the tumor. So therefore, we're looking to increase progression-free survival and overall survival without enhancing the toxic side effects of the standard of care drugs.

Okay. It obviously makes sense. And along those same lines you've talked about, you've got a number of different partners, clinicians, researchers that are working with you across the globe. How would you categorize the level of interest because you can't obviously do everything given the fact that you're maximizing your resources, but you're still a small company. How do you decide on what programs initiatives, collaborators, you're going to go forward with? And in terms of what else you would like to expand to, if given resources and everything else are always possible, given the number of queries, I'm sure you probably are seeing, and I'll hop back in the queue after that.

Thanks, Steve. Once again, I'll provide some general commentary and turn to Kristen for some specifics. But when we embarked upon our development plan creation, Kristen and her team as well as a large number of key opinion leaders who were consulted came up with a list of solid tumors where we felt that the presence of stroma, the lack of a satisfactory outcome with current standard of care and all sort of toxic side effects all combined to leave an opportunity for an unmet medical need and an improvement where LSTA1 could make a difference. And that's how we started and chosen which tumor types to initially work up. We've chosen our partners very, very simply and pragmatically. We choose people who are not only enthusiastic but who are pragmatic and can actually operate in the clinic. And I don't mean physically operate on a patient, but I mean execute in the clinic and get clinical trials done. They can enroll efficiently, effectively, they can follow the protocols. And in some cases, they contribute some or all of the capital needed to allow us to move forward in a manner that will advance the development status of the compound from a regulatory perspective, not just provide interesting data to write medical journal papers. And so that's basically how we've chosen what we're working on and with whom we're working. But Kristen can add to that. And also, we have a list of things that we'd like to do should we find additional resources in the near future that might allow us to do so. Kristen, would you like to add some color, please?

Actually, David, I think you did a really great job in answering that. I mean, we've described before how we chose the tumor types we've chosen. They're very difficult to treat cancers with hostile tumor microenvironment with dense stroma, where the standard of care today is just suboptimal. And when we explored with key opinion leaders around the world, where they felt our technology wouldn't work best, we landed on the list of cancers in which we're currently studying. I think, as Dave mentioned, we are picking sites, investigators, et cetera, based on their scientific rigor and understanding that this drug needs to get through registration as soon as possible. And our partners, we ensure that we are doing our drug development in the most capitally efficient way we can. And so we're seeking funding by alternative means and allowing our drug to be exploited both in pancreatic cancer and other solid tumors.

Got it.

And if I may, I'll just add one additional commentary. And once again, I'll bounce it back to Kristen. When you talked about, Steve, how the medical communities reacting and what the level of enthusiasm is, I think Kristen can provide some real insight to that based on her recent visits at the ASCO conference in June.

Sure, Dave. We -- the team visited the ASCO conference in June to socialize the BOLSTER trial, which is the solid tumor trial in cholangiocarcinoma, head and neck and esophageal carcinoma. We had tremendous interest from KOLs across the United States and around the world, including China, wanting to evaluate our product not only in the BOLSTER trial but in other trials where they felt this asset would be most effective. So it was very heartening to see that the news is getting out that this drug has the ability to be a platform play and that we have really interesting PIs who are eager to be part of our study.

Our next question comes from Pete Enderlin with MAZ Partners.

Congratulations on the multiplicity of programs that you're standing up at this point. First question is, does the cash runway that you've projected of close to 11 quarters include some assumption about milestone payments?

Pete, thanks very much for your kind words. At this point, our cash projections do not include any projections of incoming capital except perhaps for the remaining available capital for which we are eligible from the New Jersey NOL program. But we are not looking at milestone pay, or we have not considered milestone payments, capital raises or any other BD or M&A deals in that projection. So it's a very conservative projection.

Okay. And over that close to three-year period, is it possible that there will be some milestone payments or you're just sort of not -- I mean, you're not counting on them, but are there ones that could happen in that timeframe?

Yes, there are. We have a publicly announced license deal with Qilu Pharmaceuticals in China which has developments and regulatory milestones built into it. And there is -- I'd say a reasonable possibility that some of those milestones could be achieved over the course of the next several years.

Okay. And then on the transfer of the TPN technology, are there any potential royalties included in that if such should be possible? I mean sales eventuate?

Yes, so that the TPN deal is a typical deal, in that we have transferred the asset to another party, which will finance its development and we've retained a proportion of ownership in that, and we expect that we'll also have the ability to achieve future benefit from sales and other deals should they occur.

Other than the ownership portion, would you actually have and is it written into the agreement that there would be royalties?

Off the top of my head, I don't recall that at this point, Steve. But John can get back to you post meeting after we go back to the contract. It was just recently signed. And I don't recall if it has any specific royalties in the offer, it just starts with the substantial equity ownership in Impilo.

Okay. And can I ask one more? Do you want me to jump back in the queue.

Go ahead and finish up, Pete.

Okay. The press release mentioned possible conditional approvals for the ASCEND trial. And the question first is are protocols for conditional approval in various regulatory agencies around the world pretty similar? Or would it vary a lot by which country you're talking about?

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.

Does that -- I mean, how many different agencies do you contemplate approaching initially for that kind of program?

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.

And China, I guess, too, right?

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.

Okay, thank you very much for the information.

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.

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

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?

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.

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?

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.

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?

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?

No, you are correct, Dave. And we have procured the cisplatin to be able to supply our Bolster trial.

This concludes the question-and-answer session. I'll turn the call back to Dr.Mazzo for closing remarks.

Well, 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 great day.

This concludes today's conference call. Thank you for participating. You may now disconnect.