Lisata Therapeutics, Inc.

Welcome to the Lissata Therapeutics second quarter 2023 financial results and business update conference call. Currently, all participants are in a listen-only mode. Following management's prepared remarks, we will hold a Q&A session. To ask a question at that time, please press star 1 1 on your telephone. You will then hear an automated message advising you your hand is raised. As a reminder, the call is being recorded today. Tuesday, August 15, 2023. I will now turn the call over to John Mendito, Vice President of Investor Relations and Corporate Communications at Lasada. Please go ahead, sir.

Thank you, Operator, and good morning, everyone. Welcome to Lasada'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 and Development and Chief Financial Officer, and James Nisko, Vice President of Finance and Treasury. Yesterday, Monday, August 14th, we issued a press release after market 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 email distribution list, please email me at jmendito at 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 limitations, It forms 10Q, 8K, and 10K, 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. FASADA 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 Lesado. 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, Lasada is a clinical stage pharmaceutical company focused on the development of a novel solid tumor targeting and penetration technology to improve the efficacy of anti-cancer drugs. Our development portfolio contains programs that are designed to bring significant therapeutic improvement in the treatment of solid tumors in a pharmaco-economically attractive paradigm. Lista-1, 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 anti-cancer agents of differing modalities. Based on substantial preclinical and, most importantly, early clinical data in humans, we believe that ListaOne 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 Slatt, former LASADA 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 membranes 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 a 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, LASADA will receive an equity stake in Impilo Therapeutics. Lestada will also receive a seat on MPILO'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 Nisko, 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 and development expenses remained constant at approximately 3.2 million for the three months ended June 30th, 2023, and three months ended June 30th, 2022. Expenses this quarter were primarily due to study startup activities associated with the LISTA-1 bolster trial, enrollment activities for the LISTA-1 ASCEND study, and chemistry, manufacturing, and control activities for a list of one to support all development activities. General and administrative expenses were approximately 3.7 million for the three months ended June 30th, 2023, compared to 3.5 million for the three months ended June 30th, 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, 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 30th, 2023, the company had cash, cash equivalent, 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. Kristin Buck. for the review of our clinical development pipeline. Kristen?

Thank you, James, and good morning, everyone. As those that follow us know, Lasada'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 healthcare 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, Lista1, for the treatment of advanced solid tumors in combination with other anti-cancer 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 limits access of most pharmacotherapies to the tumor. Many tumors also exhibit a hostile tumor microenvironment or TME, which suppresses a patient's immune system and makes it less effective in fighting cancer. The combination of dense stroma and a hostile tumor microenvironment negatively impacts the ability of many cytotoxic agents and immunotherapies to effectively treat these cancers. coupled with the fact that most anti-cancer 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, Lasada's approach is to activate the C-end rule, or SEND-R system, a naturally occurring active transport system to selectively deliver anti-cancer drugs through the stoma and into the tumor. Lysada's lead product candidate, Lista-1, is an investigational drug that actuates the Sendar active transport mechanism while also having the potential to modify the tumor microenvironment and make it less immunosuppressive. Lista-1 targets tumor, vascular, and epithelial cells as well as tumor cells themselves based on its affinity for alpha-V, beta-3, and beta-5 integrins that are upregulated on these cells. but not on healthy tissue. Lista-1 is a 9-amino acid cyclic internalizing RGD peptide that, once found in these integrins, is cleaved by protease. Protease is expressed in the tumor microenvironment to release a peptide fragment called the Send-R fragment. The Send-R fragment then has high affinity for and binds to an adjacent receptor called Neuropilin-1. also upregulated on tumor endothelial and tumor cells to activate the CN rule active transport pathway and ferry anti-cancer drugs more efficiently into solid tumors. Additionally, LISTA-1 has been shown in a range of preclinical models to modify the tumor microenvironment, making it less hostile to immune cells and adding to the efficacy of anti-cancer drugs used against solid tumors. These results come internally from LASADA and from collaborators and research groups around the world and have been the subject of over 300 scientific publications. Along with our collaborators, we have amassed significant non-clinical data demonstrating enhanced delivery of a range of emerging anti-cancer therapies, including immunotherapies and RNA-based therapeutics. Clinically, LISTA-1 has demonstrated favorable safety, tolerability, and activity to enhance delivery of standard of care chemotherapy for patients with metastatic pancreatic cancer. Our development programs are designed to exploit the potential of LISTA-1 to enhance a variety of anti-cancer treatment modalities in a range of solid tumors. Currently, LISTA-1 is the subject of about a dozen plans or active clinical trials globally for the treatment of various solid tumors. Let me touch on a few of these individually. The ASCEND trial is a 155-patient, double-blind, randomized, placebo-controlled clinical trial evaluating a list of ones in combination with gemcitabine and nabpaclitaxel in patients with metastatic pancreatic ductal adenocarcinoma. The trial is being conducted at up to 40 sites in Australia and New Zealand, led by the Australasian Gastrointestinal Cancer Trials Group, or AGITG, in collaboration with the NHMRC Clinical Trial Center at the University of Sydney. We originally projected enrollment completion by the second quarter of 2024. However, with the study nearly 75% enrolled, we could achieve last patient in sooner than that. Just recently, we, along with our clinical research partner, WORP9, treated our first five patients in the I-Lista trial in Australia, evaluating Lista-1 in combination with standard of care chemotherapy, that is gemcitabine and nab piclitaxel chemotherapy, and immunotherapy using Dervalamab as a first-line treatment in locally advanced yet non-resectable pancreatic ductal adenocarcinoma. This is the first of several planned trials in which we are expanding the study of LISTA-1's impact on existing therapies to include immunotherapies. We also expect enrollment completion in this trial by the second quarter of 2024. The company's bolster trial of LISTA-1 is a Phase IIa placebo-controlled basket trial in the United States, Europe, Canada, and Asia. evaluating Lista-1 in combination with standards of care in solid tumors, including head and neck, esophageal, and cholangiocarcinoma. This trial includes both cytotoxics and immunotherapy standards of care. Enrollment is now open. However, we, like many others, are being impacted by the global cisplatin shortage, which is part of the standard of care regimen for cholangiocarcinoma patients. This has led to severe shortages of the drug, long delays in obtaining any available material, and unfortunately, price gouging by some suppliers resulting in prices reaching hundreds of times of what cisplatin would normally cost. Despite these challenges, our team has identified and secured a supply of cisplatin sufficient to the needs of the bolster trial, and we expect this material in our hands and available to patients in our study within about one month. Once this requirement, this required component of Bolster's protocol is at the investigational sites, we look much forward to announcing the first patient treated in the cholangiocarcinoma arm. Next is the SendaFox trial, a Phase 1b-2a open-label trial of Lista-1 in combination with neoadjuvant fulthurinox-based therapies in pancreatic, colon, and appendiceal cancers. It continues to make steady progress with approximately 80% of the study enrolled. We expect enrollment completion by the fourth quarter of this year with data readouts in 2024. This trial will provide us with post-treatment biopsy immunoprofiling data as well as long-term outcome data. Lista-1 is also currently being evaluated in combination with gemcitabine and nabpaclitaxel in a Phase 1b, 2a open-label trial in China. led by our licensee in that territory, Chilu Pharmaceutical. During the 2023 ASCO annual meeting, Chilu Pharmaceutical presented an abstract sharing preliminary data from the study which corroborated previously reported findings from the Phase 1b2a trial of Lista1 plus gemcitabine and nabpaclitaxel conducted in Australia in patients with metastatic pancreatic ductal adenocarcinoma. Final data are expected by the end of the second quarter of 2024. IGOLISTA, a Phase 1b-2a proof of concept safety and early efficacy study evaluating Lista-1 in combination with nivolumab and fulpirinox as a first-line treatment in locally advanced non-resectable gastroesophageal adenocarcinoma is still pending initiation as a function of availability of funding by our partner, Warp 9. We hope to have further updates on timing related to the execution of the study by the end of the third quarter of this year. In addition to the ongoing clinical trials I just mentioned, we also plan to have other studies up and running in the next few months, including Lista-1 in combination with temozolomide and glioblastoma multiforme, commonly known as GBM. This study is designed as a Phase IIa double-blind, placebo-controlled, randomized proof-of-concept study evaluating Lista-1 when added to standard-of-care temozolomide versus temozolomide and matching Lista-1 placebo in patients with newly diagnosed glioblastoma multiforme. It will be conducted across multiple sites in Estonia and Latvia, and it is targeted to enroll 30 patients with a randomization of 2 to 1 Lista 1 plus standard of care versus placebo plus standard of care. Target for first patient treated is in the fourth quarter of 2023. Importantly, and as recently announced, Lista 1 has been granted orphan designation by the U.S. Food and Drug Administration for malignant glioma. This action by FDA not only highlights the unmet medical needs, but also recognizes the potential of Lista 1 to benefit patients in this indication. Lastly, we are planning to study Lista-1 in combination with hyperthermic intraperitoneal chemotherapy, more commonly referred to as HIPEC, delivered via intraoperative intraperitoneal lavage in peritoneal carcinomatosis, a cancer that develops as a result of the contiguous spread of primary cancers such as ovarian, colorectal, and appendiceal along the peritoneal layer. The study will be a phase one, single center, unblinded, randomized controlled trial to determine the safety and tolerability of list of ones administered intraperitoneally in patients with peritoneal metastasis from colorectal, appendiceal, or ovarian cancer undergoing cytoreductive surgery and HIPEP. Twenty-one total patients will be randomized two to one to receive Lista-1 with HIPEC versus HIPEC alone after cytoreductive surgery. We anticipate that this study will also be up and running in the fourth quarter of 2023 and the first patient being completed shortly thereafter. For those who are interested, a more complete description of our trials is available in the appendix section of the corporate presentation on our website. Additionally, in the body of the presentation, there are two milestone slides that describe the anticipated timing of key execution milestones and data readouts for our trials. With that, I will now turn the call back to Dave.

Thanks, Kristen. As we look back to the beginning of the year and even further to the status of development of LISTA-1 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 Lista-1 in MPDEC and broad application of Lista-1 in combination with a variety of anti-cancer 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.

Thank you. As a reminder, to ask a question, please press star 11 on your telephone. You will then hear an automated message advising that your hand is raised. Each listener will be permitted to ask one question at a time and will return to the queue for any additional questions.

One moment for our first question in the queue.

We have a question from Joseph Pentaginous with HCWCO. Your line is open.

Hi. Good morning. Sarah Onforgea taking the question. I was wondering, based on the brisk enrollments that you've seen for the ASCEND, can you possibly gauge expectations where we could expect a potential data readout? Thank you.

Well, thanks, Sarah. I appreciate your question. Good morning. You know, right now, the ASCEND trial protocol is very specific. It's a blinded trial of the two cohorts, as Kristen aptly described, and, you know, 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 of 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.

Thank you.

Thank you. One moment for our next question. We have a question from Steve Brozek with WBB Securities.

Your line is open.

Yes. Good morning and thanks for taking the questions. 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 non-traditional as far as what you expect? And I have one follow-up after that. Thank you.

Well, thanks, Steve. Good morning. I'll answer the question generally, and then I'll turn 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 nine or so months, and less than 10 or so percent of the people diagnosed survive up 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, Dave. 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 diagnoses and prognoses. 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 cytotoxics. We're trying to target the tumors so the cytotoxics and immunotherapies are specifically going into the tumor. So therefore, Steve, we're looking to increase progression-free survival and overall survival without enhancing the toxic side effects of these 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, you know, 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 into queue after that. Thank you.

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 standards of care, and all sorts of toxic side effects, all combined to leave an opportunity for an unmet medical need and an improvement where ListaOne could make a difference. And that's how we've started and chosen which tumor types to initially work on. We've chosen our partners 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 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. basically how we've chosen what we're working on and with whom we're working. But, you know, Kristen can add to that. And also that 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, Dave, 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 microenvironments, 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 would 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. Well, again, thanks for taking the question and the answers.

Thanks. 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, you know, how the medical community is reacting and, you know, 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, as a 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 interested PIs who are eager to be part of our studies.

Thank you.

Our next question comes from Pete Enderlin with MAV Partners. Your line is open.

Good morning. Thanks for taking my questions. And 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?

Good morning, 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 – well, 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 are you just sort of not I mean, you're not counting on them, but are there ones that could happen in that time frame?

Yes, there are. We have a publicly announced license deal with Chile Pharmaceutical 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 products,

technology um are there any potential royalties included in that if such should be possible i mean you know sales eventuate yeah so the tpn deal is a typical deal in that we have transferred the the asset to you know another party which will finance its development and we've retained a portion of ownership in that and we expect that we'll also have the ability to achieve you know, 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?

You know, off the top of my head, I don't recall that at this point, Steve, but John can get back to you, you know, post-meeting after we go back to the contract. It was just recently signed and I don't recall if it has, you know, specific royalties in it, or if it just starts with the, you know, substantial equity ownership in Impilo.

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

Go ahead.

Go ahead and finish up, Pete. Okay. You know, the press release mentioned possible conditional approvals for the CENTRAL. 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 and 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.

And does that, I mean, How many different agencies do you contemplate approaching initially for that kind of a program?

Oh, at least, well, 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, well, but, you know, China is being handled by our licensee, Chilu. So, you know, they're there. They have their own development program, which does include the accelerated path, what 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.

You're welcome, Pete. And 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. Okay, thanks a lot.

Thank you.

And our next question will come from Kemp Deliver with Brookline Capital Markets. Your line is open.

Great, thank you, and good morning. 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?

So, good morning, Kemp. 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, you know, supporting 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 TESOLizumab. So we're just on standby waiting.

Okay, great. And then, you know, my last question relates to cisplatin, and 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. 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 nabpaclitaxel. 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 cisplatinin to be able to supply our bolster trial.

Great. Great. Those are all my questions. Thank you, Kim.

Thank you. 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.