Lisata Therapeutics Q2 2024 Earnings Call Transcript

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Provided by Quartr
August 12, 2024

Key Takeaways

  • For Q2 2024, operating expenses fell 19.7% year-over-year to $5.5 M, reflecting improved cost controls, and the company expects its $38.3 M cash runway to fund operations into early 2026.
  • Net loss widened to $5.0 M in Q2 2024 from $4.0 M a year ago, while benefit from income taxes was $0 versus $2.3 M in the prior period.
  • The ASCEND Phase 2b trial in metastatic pancreatic cancer passed an interim futility analysis, with top-line data from Cohort A of 95 patients expected in Q4 2024 and full data by mid-2025.
  • The BOLSTER Phase 2a trial in cholangiocarcinoma completed first-line enrollment six months ahead of plan and has added a second-line cohort set to start in Q4 2024.
  • Certepatide has secured multiple regulatory designations, including FDA Fast Track, orphan drug in the U.S. and EU, a rare pediatric disease designation, and an EMA pediatric waiver, positioning it for priority review pathways and extended exclusivity.
AI Generated. May Contain Errors.
Earnings Conference Call
Lisata Therapeutics Q2 2024
00:00 / 00:00

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Operator

Welcome to the Lisata Therapeutics second quarter 2024 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 question-and-answer session. To ask a question at that time, please press star one one on your telephone. You will then hear an automated message advising you that your hand is raised. As a reminder, this call is being recorded today, Monday, August 12, 2024. I will now turn the call over to John Menditto, Vice President of Investor Relations and Corporate Communications at Lisata. Please go ahead, sir.

John Menditto
John Menditto
VP of Investor Relations and Corporate Communications at Lisata Therapeutics

Thank you, operator, and good afternoon, everyone. Welcome to Lisata's second quarter 2024 conference call to discuss our financial results and to provide a business update. Joining me 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 Medical Officer, and James Nisco, Senior Vice President of Finance and Treasury, and Chief Accounting Officer. Shortly before this call, we issued a press release announcing our second quarter 2024 financial results, which is available under the Investors and News section of the company website, along with a webcast replay of this call. If you have not received this news release or if you'd like to be added to the company's email distribution list, please subscribe to email alerts on the company website or email me at jmenditto@lisata.com to be added.

John Menditto
John Menditto
VP of Investor Relations and Corporate Communications at Lisata Therapeutics

Before we begin, I will 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, Monday, August 12th, 2024. Lisata Therapeutics undertakes no obligation 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?

David Mazzo
David Mazzo
CEO at Lisata Therapeutics

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 second quarter 2024 financial results, and give an update on the progress of our clinical development programs. During the second quarter of this year, Lisata maintained strong momentum in the advancement of our development pipeline, centered around our novel investigational product, certepetide, in combination with a variety of anticancer agents of differing modalities for the treatment of advanced solid tumors. As we have previously reported, consistently 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 for many challenging solid tumors.

David Mazzo
David Mazzo
CEO at Lisata Therapeutics

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. With that, I will now turn the call over to James Nisco, our Senior Vice President of Finance and Treasury and Chief Accounting Officer. James?

James Nisco
James Nisco
SVP of Finance and Treasury and Chief Accounting Officer at Lisata Therapeutics

Thanks, Dave. Good afternoon, all. I'm pleased to join you today to present a summary of our second quarter 2024 financial results. Starting with operating expenses. For the three months ended June 30, 2024, operating expenses totaled $5.5 million, compared to $6.9 million for the three months ended June 30, 2023, representing a decrease of $1.4 million or 19.7%. Research and development expenses were approximately $2.6 million for the three months ended June 30, 2024, compared to $3.2 million for the three months ended June 30, 2023, representing a decrease of $0.6 million or 17.7%. This was primarily due to a reduction in expenses associated with the Phase IIb ASCEND trial, which completed enrollment in the prior year.

James Nisco
James Nisco
SVP of Finance and Treasury and Chief Accounting Officer at Lisata Therapeutics

Lower spend on chemistry, manufacturing, and control, or CMC, related expenses, and lower equity expense, partially offset by an increase in expenses associated with enrollment activities in the current year for our BOLSTER trial. General and administrative expenses were approximately $2.9 million for the three months ended June 30, 2024, compared to $3.7 million for the three months ended June 30, 2023, representing a decrease of $0.8 million or 21.3%. This was primarily due to one-off related severance costs in the prior year associated with the elimination of the chief business officer position on May 1, 2023, a reduction in equity expense, and a decrease in directors' and officers' insurance premiums in the current year.

James Nisco
James Nisco
SVP of Finance and Treasury and Chief Accounting Officer at Lisata Therapeutics

Benefit from income taxes was 0 for the three months ended June 30, 2024, compared to $2.3 million for the three months ended June 30, 2023. In April 2023, we received net proceeds of $2.2 million from the sale of tax benefits to a qualified and approved buyer pursuant to the New Jersey Economic Development Authority's Technology Business Tax Certificate Transfer Program. Overall, net losses were $5 million for the three months ended June 30, 2024, compared to $4 million for the three months ended June 30, 2023. It is noteworthy that we continue to make progress according to our plans for our research and development and business activities, while still continuing our legacy of prudent capital management and expense minimization. Turning now to our balance sheet and cash flow.

James Nisco
James Nisco
SVP of Finance and Treasury and Chief Accounting Officer at Lisata Therapeutics

As of June 30, 2024, Lisata had cash, cash equivalents, and marketable securities of approximately $38.3 million. Based on its current expected capital needs, the company believes that its projected capital will fund its current proposed operations into early 2026, encompassing anticipated data milestones from all its ongoing and planned clinical trials. With that, I now turn the call over to Dr. Kristen Buck to provide an overview of the company's development programs. Kristen?

Kristen Buck
Kristen Buck
EVP of Research and Development and CMO at Lisata Therapeutics

Thank you, James, and good afternoon, everyone. As I've mentioned many times in the past, Lisata's development programs are built upon a strong foundation of published preclinical and early clinical research. Notably, our CendR platform technology is rooted in pioneering discoveries recognized by the Lasker Prize awarded to Dr. Erkki Ruoslahti. A product of the CendR platform, certepetide, is designed to address the major impediments to the successful treatment of advanced solid tumors. This is especially relevant in an environment of increasing prevalence of these cancers and growing pharmacoeconomic pressures. Our clinical studies have been rigorously designed with the end in mind, that is, eventual product registration, and are optimized to generate clinically meaningful, unambiguous data. As such, unlike many studies at a similar stage of development, our studies are placebo-controlled, appropriately sized, and employ primary endpoints that are preferred by regulatory authorities in support of pivotal trials.

Kristen Buck
Kristen Buck
EVP of Research and Development and CMO at Lisata Therapeutics

Further, our trials evaluate certepetide in combination with current standard of care therapies 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, 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 development mantra of "Do the last experiment first" to avoid 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 that afford us priority reviews and the possibility of accelerated approvals.

Kristen Buck
Kristen Buck
EVP of Research and Development and CMO at Lisata Therapeutics

However, before I get to the specifics of each of the clinical studies in our development portfolio, please allow me to summarize some important background information, especially for those who are listening for the first time. Despite advances in cancer therapy, including CAR T-cell therapy and immunotherapies, many solid tumors are still associated with poor outcomes for patients. Cancers such as pancreatic cancer, gastric cancers, glioblastoma multiforme, and other solid tumors are surrounded by a dense fibrotic tissue known as the stroma, which limits access of most pharmacotherapies to the tumor. In addition, many solid tumors also present a hostile tumor microenvironment, or TME, which suppresses a patient's immune system and makes it less effective in fighting cancer. The combination of a dense stroma and a hostile tumor microenvironment prevents many chemotherapies and immunotherapies from being optimally effective in treating these cancers.

Kristen Buck
Kristen Buck
EVP of Research and Development and CMO at Lisata Therapeutics

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, our investigational product, certepetide, leverages the naturally occurring CendR active transport system to provide an innovative approach to the selective delivery of anticancer drugs through the tumor stroma and directly into the tumor. Simultaneously, certepetide has been shown to modify the tumor microenvironment, making it less immunosuppressive and therefore increasing the tumor's susceptibility to immunotherapy while also inhibiting the metastatic cascade. Certepetide is a nine-amino acid cyclic peptide with high binding affinity and specificity for alpha-v beta-3 and beta-5 integrin receptors, which are significantly upregulated on tumor vascular endothelial cells and tumor cells themselves, but not on healthy tissue.

Kristen Buck
Kristen Buck
EVP of Research and Development and CMO at Lisata Therapeutics

Once bound to these integrins, certepetide is subjected to proteolytic cleavage by enzymes naturally occurring in the tumor microenvironment to produce two linear fragments, one of which is a five-amino acid CendR peptide fragment. Upon dissociation of the CendR fragment from the integrin receptor, it binds to another receptor called neuropilin-1 on the same or a nearby cell. Once neuropilin-1 is activated, it actuates the CendR active transport mechanism, which is manifested by the formation of microvesicles at the surface of the cells. These microvesicles encapsulate any co-administered anticancer drugs, unbound certepetide, and CendR fragments in the circulatory system and ferry them through the stroma and vasculature into the tumor.

Kristen Buck
Kristen Buck
EVP of Research and Development and CMO at Lisata Therapeutics

Certepetide's mechanism of action is agnostic to the modality of the companion anticancer drugs with which it is administered, and can be combined with a wide range of existing or even emerging anticancer therapies, including chemotherapies, immunotherapies, and RNA-based therapies. Additionally, as I previously mentioned, certepetide has been shown in a range of preclinical models to modify the tumor microenvironment, making it less hostile to immune cells, reducing tumor resistance to anticancer medications, and impeding and/or preventing the metastatic cascade. These results come from Lisata-sponsored studies and from collaborators and research groups around the world, and have been the subject of more than 350 scientific publications relevant to certepetide's mechanism of action. Along with our collaborators, we also have amassed significant non-clinical data demonstrating enhanced delivery and augmented efficacy of a range of anticancer therapy modalities, including chemotherapies, immunotherapies, RNA-based therapeutics, and even cell therapies.

Kristen Buck
Kristen Buck
EVP of Research and Development and CMO at Lisata Therapeutics

To date, certepetide has also demonstrated favorable clinical safety, tolerability, and activity to enhance delivery of standard of care chemotherapy for patients with metastatic pancreatic cancer. In addition, our strategic focus on regulatory optimization has yielded significant results, as evidenced by multiple special designations awarded to certepetide. To date, certepetide is the recipient of a Fast Track designation by the FDA, which affords us more frequent interactions with the FDA and the ability to submit NDA components early for a rolling review. Certepetide will also be eligible for accelerated approval and priority review if relevant criteria are met. Further, certepetide has received multiple orphan drug designations, including one for pancreatic cancer in both the United States and Europe, as well as for malignant glioma in the U.S. Orphan Drug Designation.

Kristen Buck
Kristen Buck
EVP of Research and Development and CMO at Lisata Therapeutics

Orphan drug designation affords Lisata exemption from FDA user fees and provides extended market exclusivity, as well as other potential sponsor benefits. In just the first half of 2024, certepetide has not only been granted a pediatric investigation plan waiver by the EMA for the treatment of pancreatic cancer, but has also received an orphan designation and a rare pediatric disease designation for osteosarcoma in the United States. For background, the FDA defines rare pediatric diseases as diseases with fewer than 200,000 cases in the United States that are serious or life-threatening and primarily affect individuals under 18 years of age. This program is set to expire on September 30, 2024. However, our expectation, and the expectation of many in the industry, is that the program will be reauthorized. We will, of course, be monitoring those developments closely.

Kristen Buck
Kristen Buck
EVP of Research and Development and CMO at Lisata Therapeutics

A substantial benefit under the current Rare Pediatric Disease Designation Program is receipt of a priority review voucher, often referred to as a golden ticket, once the FDA approves the new drug application or NDA for the product and indication having received the designation. Vouchers are especially valuable as they can be used to compel a priority review of an additional NDA or biologic license application for another product or indication, reducing the standard review time of approximately 10 months to 6 months. The voucher may be used by the sponsor or sold to another sponsor for their use. Priority review vouchers have sold for as much as $350 million US dollars historically, and more recently have sold for $75 million-$100 million dollars.

Kristen Buck
Kristen Buck
EVP of Research and Development and CMO at Lisata Therapeutics

Overall, our development strategy includes the pursuit of a rapid certepetide registration for the treatment of pancreatic cancer, alongside studies which further exploit certepetide's ability to enhance a variety of anticancer treatments in a range of advanced solid tumors. To this end, certepetide is currently the subject of nearly a dozen planned or active clinical trials globally for the treatment of various solid tumors. For example, the ASCEND trial is a 158-patient, double-blind, randomized, placebo-controlled clinical trial evaluating certepetide in combination with standard of care gemcitabine and nab-paclitaxel chemotherapy in patients with metastatic pancreatic ductal adenocarcinoma or mPDAC. The trial is being conducted at 25 sites in Australia and New Zealand, led by the Australasian Gastro-Intestinal Trials Group, or AGITG, in collaboration with the NHMRC Clinical Trials Centre at the University of Sydney. The study consists of two cohorts.

Kristen Buck
Kristen Buck
EVP of Research and Development and CMO at Lisata Therapeutics

Cohort A of the study receives a single dose of 3.2 mg/kg certepetide, essentially simultaneously with standard of care, while Cohort B is identical to Cohort A, but with a second dose of 3.2 mg/kg certepetide given 4 hours after the first. As previously reported, a positive outcome from the planned interim futility analysis in 2023 was announced by the study's independent Data Safety Monitoring Committee, which recommended continuation of the study without modification. With trial enrollment completed in the fourth quarter of 2023, we expect top-line data from the 95 patients assigned to cohort A of the study to be reported in the fourth quarter of 2024, and the complete data set of all 158 patients from the study to be available by mid-2025.

Kristen Buck
Kristen Buck
EVP of Research and Development and CMO at Lisata Therapeutics

The prospect of positive data is encouraging, and we have begun planning the subsequent development steps. For example, we have already received an opinion from the Therapeutic Goods Administration, or TGA, which is the Medicine and Therapeutic Goods Regulatory Agency of the Australian Government, that they believe positive data from the ASCEND cohort A, in conjunction with our phase Ib/IIa data, could warrant submission of an application for provisional determination, the Australian version of a conditional approval. We expect similar discussions with the FDA and EMA once the data are in hand. We have already anticipated and designed the required phase III study that will be necessary to maintain a conditional approval and support a full registration once completed. The ASCEND data anticipated this year will further inform and optimize our proposed phase III clinical program in metastatic pancreatic cancer.

Kristen Buck
Kristen Buck
EVP of Research and Development and CMO at Lisata Therapeutics

The BOLSTER trial is our phase IIa double-blind, placebo-controlled, multicenter randomized trial in the United States evaluating certepetide in combination with standard of care in first-line cholangiocarcinoma. As we have reported recently, Lisata achieved complete enrollment in this study nearly six months ahead of plan, accelerating top-line data readout to mid-2025. Based on this rapid enrollment rate and the pressing need to improve treatment outcomes in patients that have progressed after first-line treatment, a second cohort of patients has been added to the BOLSTER trial, evaluating subjects in second-line cholangiocarcinoma, and we expect to enroll the first patient by the fourth quarter of 2024. CENDIFOX is a phase Ib/IIa open-label trial in the United States evaluating certepetide in combination with neoadjuvant FOLFIRINOX-based therapies in pancreatic, colon, and appendiceal cancers.

Kristen Buck
Kristen Buck
EVP of Research and Development and CMO at Lisata Therapeutics

The trial has completed enrollment in the pancreatic cohort and remains on track to complete enrollment in the remaining two cohorts by the end of 2024. Qilu Pharmaceutical, the licensee of certepetide in the Greater China territory, is also currently evaluating certepetide in combination with gemcitabine and nab-paclitaxel as a treatment for metastatic pancreatic cancer. During the 2023 ASCO annual meeting, Qilu Pharmaceutical presented an abstract sharing preliminary data from the study, which corroborated previously reported findings from the phase Ib/IIa trial of certepetide plus gemcitabine and nab-paclitaxel conducted in Australia in patients with pancreatic cancer. Additionally, Qilu has begun treating patients in their phase II placebo-controlled trial in metastatic pancreatic cancer. The study is planned to take approximately 18 months to complete enrollment accrual and another 13 months for patient follow-up and data analysis and reporting.

Kristen Buck
Kristen Buck
EVP of Research and Development and CMO at Lisata Therapeutics

In collaboration with our funding partner, Warp Nine, the iLSTA trial is a phase Ib/IIa, randomized, placebo-controlled, single-blind, single-center, safety, early efficacy, and pharmacodynamic trial in Australia. This three-cohort study is evaluating certepetide in combination with the checkpoint inhibitor durvalumab, plus standard of care gemcitabine and nab-paclitaxel chemotherapy, versus certepetide in combination with standard of care alone, versus standard of care alone in patients with locally advanced non-resectable pancreatic cancer. Enrollment completion is expected in the second half of 2024. iGOLSTA, a phase Ib/IIa proof-of-concept safety and early efficacy study evaluating certepetide in combination with nivolumab and FOLFIRINOX as a first-line treatment in locally advanced non-resectable gastroesophageal adenocarcinoma, is pending initiation as a function of availability of funding by our partner, Warp Nine.

Kristen Buck
Kristen Buck
EVP of Research and Development and CMO at Lisata Therapeutics

The inspiration for this study actually comes from the findings recently published in the Oncology and Cancer Case Reports Journal, which details a patient with metastatic gastroesophageal adenocarcinoma, who achieved a complete response when given certepetide in combination with standard of care, FOLFIRINOX, and pembrolizumab. The subject initially underwent months of standard of care treatments and only achieved a partial response. Upon the subsequent addition of certepetide to the existing standard of care therapeutic regimen, the subject achieved a complete response, confirmed both radiographically and surgically. Remarkably and thankfully, the subject remains healthy since achieving complete response in February of 2023. We hope to provide an update on timing related to the execution of the iGOLSTA study in coming quarters. A study of certepetide in combination with temozolomide in glioblastoma multiforme, or GBM, has been initiated with several patients already enrolled and treated.

Kristen Buck
Kristen Buck
EVP of Research and Development and CMO at Lisata Therapeutics

This study is designed as a phase IIa, double-blind, placebo-controlled, randomized proof-of-concept study evaluating certepetide when added to standard of care temozolomide versus temozolomide alone and matching certepetide placebo in subjects with newly diagnosed GBM. This actively enrolling study is being conducted across multiple sites in Estonia and Latvia and is targeted to enroll 30 patients with a randomization of 2 to 1, certepetide plus standard of care versus placebo plus standard of care. FORTIFIED is a phase Ib/IIa, double-blind, placebo-controlled, three-arm randomized study in the United States evaluating the safety, tolerability, and efficacy of a 4-hour continuous infusion of certepetide in combination with standard of care in patients with second-line metastatic pancreatic cancer who have progressed on first-line FOLFIRINOX.

Kristen Buck
Kristen Buck
EVP of Research and Development and CMO at Lisata Therapeutics

As part of this study, we have engaged Haystack Oncology to use their MRD technology to measure circulating tumor DNA levels at multiple time points in patients throughout the study as an exploratory endpoint for analyzing the early therapeutic effect of certepetide. We expect to enroll the first patient in this study by the first half of 2025. On top of the previously described studies, we are exploring additional trials supporting our general development strategy. However, we remain steadfast in only starting trials that can be funded through data and trials that can be executed within a reasonable period of time. Finally, I would be remiss if I didn't remind you that several of the studies I mentioned are investigator-initiated trials. And although we have great confidence in the investigators running these studies, Lisata has limited control, and thus, timelines and expectations may be subject to change.

Kristen Buck
Kristen Buck
EVP of Research and Development and CMO at Lisata Therapeutics

That said, we are extremely grateful to the investigators and especially to the patients participating in certepetide clinical trials around the world. For those of you who are interested, a more comprehensive description of each trial is available in the appendix section of the corporate presentation on our website. Additionally, in the body of the presentation, there are two slides that depict the anticipated timing and execution of key milestones and data readouts from our trials. As you will see, there are numerous execution and data milestones projected from our portfolio of clinical trials over the next year and beyond. With that, I will now turn the call back to Dave.

David Mazzo
David Mazzo
CEO at Lisata Therapeutics

Thanks, Kristen. Overall, we remain optimistic about the potential of certepetide to transform the lives of patients with cancer. The upcoming ASCEND data readout will be a seminal moment for Lisata as it will provide critical insights into the efficacy and safety profile of certepetide in combination with standard of care chemotherapy for patients suffering from mPDAC. As we look ahead, we remain committed to advancing the certepetide program across multiple tumor types and exploring strategic partnerships to maximize its value. We look forward to sharing further updates on our progress throughout the year. With that, operator, we're ready to take questions.

Operator

As a reminder, to ask a question, please press star one one on your telephone. You would 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. Our first question comes from the line of Steve Brozak of WBB Securities.

Steve Brozak
Steve Brozak
Analyst at WBB Securities

Hey, good afternoon, and thanks for taking the questions. I have one specifically around you know, congrats, obviously, on the unfortunate but quick enrollment. What kind of feedback did you get from the clinicians in terms of how quick it was? And obviously, you opened up a second front as far as enrolling for additional patients. What kind of feedback have you gotten from the clinicians on not just the demand, but the need and what patients we're you know looking for as far as this? And I've got one follow-up after that. Thank you.

David Mazzo
David Mazzo
CEO at Lisata Therapeutics

Thanks, Steve. Appreciate you being on the call, and thank you for the question. You know, the feedback that we've received, and I should say that Kristen actually received directly throughout the enrollment of the first-line cholangiocarcinoma trial, was that there was a tremendous level of enthusiasm about the potential for the product and even a I would say, an assumption or a speculation that the product was doing something positive. Now, Kristen, you know, reminded the investigators that the study was blinded. Nobody knew, including them, who was receiving treatment and who wasn't. But their typical response was, "Yes, we understand, but we're seeing some of our patients do things, respond in a way that's atypical of patients with cholangiocarcinoma receiving, you know, chemotherapy.

David Mazzo
David Mazzo
CEO at Lisata Therapeutics

And so we really think that it must be due to the addition of certepetide, and we're very excited about that. Oh, and by the way, because we think something is happening in first line, there's an even greater need in second line. Would you please consider opening up a second arm or bolster in second-line cholangiocarcinoma? Because we believe that we can enroll that very rapidly as well because of the large need. And so based upon that type of feedback, we indeed did open the second-line cholangiocarcinoma study, and we hope that that will enroll as quickly as they have projected.

Steve Brozak
Steve Brozak
Analyst at WBB Securities

Got it. Okay, and on the follow-up, when you look at this kind of a response, and we obviously look at, you know, just as a reminder, what would basically standard of care be right now if, unfortunately, you didn't have this trial running? What would the standard of care be to contrast that? And I'll jump back off the queue, please, and back into the queue.

David Mazzo
David Mazzo
CEO at Lisata Therapeutics

Sure, and I'll actually call on Kristen to jump in here, you know, to talk a little bit about standard of care for the cholangiocarcinoma indication.

Kristen Buck
Kristen Buck
EVP of Research and Development and CMO at Lisata Therapeutics

Thanks, Steve. It's Kristen here. Yeah, the first-line treatment for cholangiocarcinoma or bile duct tumor is actually gemcitabine, cisplatin, and durvalumab. And the reason, you know, we designed the trial as such, we wanted to include that standard of care currently as one of the treatment arms with placebo and add certepetide to that baseline standard of care regimen. You know, for patients, this is a pretty devastating disease. These patients, you know, in the first line, perhaps live 11 months, overall survival median. And in the second line, unfortunately, they're they meet their demise between 4 and 6 months. So we're hoping to make a meaningful impact.

Operator

Thank you. Our next question comes from the line of Joseph Pantginis of H.C. Wainwright & Co.

Analyst at H.C. Wainwright & Co

Hi, good afternoon. This is Sarah on for Joe. I just had a question, actually on the Qilu Pharmaceutical trial, and for the Phase II in mPDAC. Kind of wondering how much insight you actually get into the progress of the trial, if you can provide, if you have any insight into how enrollment is progressing. I know it's about 18 months to complete accrual, but do you have any insights into how many patients have been treated to date or any other updates you get along the way? Thank you.

David Mazzo
David Mazzo
CEO at Lisata Therapeutics

Hi, Sarah. Thanks for calling in, and thanks for your question. So I think as Kristen's narrative indicated, you know, Qilu is an independent company. It's a private company in China, so they are not subject to the same rules of disclosure that public companies are. And as a result, they typically do not make any announcements about the progress of their clinical trials. They don't even announce first patient in, last patient out, or anything. They just wait until the trials are over, and they make, you know, generally a announcement through the medium of a scientific presentation at a big meeting like ASCO GI or, or ASCO. So as it relates to the phase II product, all we know is that it initiated in the second quarter because they told us.

David Mazzo
David Mazzo
CEO at Lisata Therapeutics

We have our joint steering committee meetings at least quarterly, and during that meeting, they told us they've initiated, you know, the phase II trial, and that's when they projected the roughly 18 months for complete enrollment. We are waiting for our third quarter JSC meeting to occur, and they may or may not give us a hint as to what the trial enrollment is, but they would typically say things like, "We're on track," you know, all right. At this early stage, I would imagine that they wouldn't say anything other than they're on track to meet their projected 18-month enrollment period. You know, we're a little bit blind to what's going on there, but, but if things go, you know, dramatically different from their projections, they would obviously let us know.

Analyst at H.C. Wainwright & Co

Okay, that's helpful. Thank you.

David Mazzo
David Mazzo
CEO at Lisata Therapeutics

Thank you, Sarah.

Operator

Thank you. Our next question comes from the line of Will Hittle of Brookline Capital Markets.

Will Hittle
Analyst at Brookline Capital Markets

Hey, thank you for taking the questions. I have a quick clarification question I might have missed, but, the trial, the certepetide and GBM, as of last quarter, I believe enrollment was, I think you had three patients enrolled, and I might have missed this, but, are there any updates on enrollment?

David Mazzo
David Mazzo
CEO at Lisata Therapeutics

Yeah. No, actually, thanks, Will, for calling in and the question. We don't really have any updates. You know, as you know, that trial is running in Estonia. Typically, this time of year in that part of Europe, it's a very, I would say, common vacation time, and so our lead investigator has been away for the last 10 days, and we probably won't have a chance to touch base with her for another week or so. And hopefully, during our next call, we'll have an update on enrollments from Estonia and Latvia. But, you know, we do know that the sites in Latvia are open, and we do hope that we'll see, you know, an improvement or rather an increase in enrollment over the originally announced 3 the next time we have a chance to chat.

Will Hittle
Analyst at Brookline Capital Markets

Okay. Thank you.

Operator

Thank you. Our next question comes from the line of Pete Enderlin of MAZ Partners.

Peter Enderlin
Analyst at MAZ Partners

Thank you. Hi, everybody.

David Mazzo
David Mazzo
CEO at Lisata Therapeutics

Hi, Pete.

Peter Enderlin
Analyst at MAZ Partners

Congratulations on the strong progress in the enrollment, especially in conjunction with controlling expenses very effectively. My first question is a quick one, so I'll maybe count it as a half a question. And that is, do you have any estimate of the size of the pediatric population, patient population in pancreatic cancer? I mean, we know orphan is less than 200,000, but I would think it's a lot less than that in the United States and in Europe, both. So do we have specific numbers?

David Mazzo
David Mazzo
CEO at Lisata Therapeutics

Yeah, the answer is, it's not significantly different from zero.

Peter Enderlin
Analyst at MAZ Partners

Yeah.

David Mazzo
David Mazzo
CEO at Lisata Therapeutics

It's not a disease that's actually found in you know, in children, basically.

Peter Enderlin
Analyst at MAZ Partners

Right. Okay, and then, more substantively, you know, looking ahead, which, you know, the, the investment community always tries to do, and, and sometimes it's difficult. But the, the question is, are there other companies, drugs in clinical trials, not, not existing standard of care, but ones where there are ongoing clinical trials, where tying it in with certepetide conceptually or potentially could make the difference between approval of that drug and that series of clinical trials or, or not? And do you have any ongoing conversations with other drug companies about that kind of situation? I'm not looking for, you know, we know that, that it helps in, in, conjunction with nab-paclitaxel and, you know, those other standards of care, but this is for new drugs. What's the outlook for that?

David Mazzo
David Mazzo
CEO at Lisata Therapeutics

So the simple answer to your two questions are yes and yes. You know, as I said, or as Kristen actually said, the mechanism of action of certepetide is agnostic to the modality of the companion anticancer agent. That's, you know, fairly fancy speak for saying that it doesn't matter what type of anticancer drug you use, if you mix it with certepetide, you should expect an improvement. And so we actually would expect that it could help for products that are currently approved as well as products that are under investigation.

David Mazzo
David Mazzo
CEO at Lisata Therapeutics

And we have, in fact, spoken to a number of companies who are studying their products for pancreatic cancer and other solid tumors, and, you know, have a, I would say, ongoing dialogue to see if we can find a way to collaborate that gives both opportunity for both products, certepetide and theirs, another shot on goal, but still falls within our, you know, strategic remit here of making sure that we can afford whatever we do.

Peter Enderlin
Analyst at MAZ Partners

Yeah. And so Dave, does that mean that some of these companies have actually approached you? Because you don't necessarily know everything that's going on in these different cancer trials, and and maybe have a drug that they're not that confident about, but they know that if it gets improved efficacy thanks to your drug, that that would make the difference. Is there some of that kind of dialogue going on?

David Mazzo
David Mazzo
CEO at Lisata Therapeutics

Yes, that is, that is some of that. And some of it is, of course, we scour the clinical trial roles constantly looking for products that, you know, for one reason or another, are not behaving as positively as everyone hoped, but that could benefit from a combination with certepetide. So it kind of goes both ways.

Peter Enderlin
Analyst at MAZ Partners

Right. Okay, thank you very much.

David Mazzo
David Mazzo
CEO at Lisata Therapeutics

Sure.

Operator

Thank you. Our next question comes from the line of Robert Sassone of Water Tower Research. Our next question comes from Robert Sassone of Water Tower, Water Tower Research. Please go ahead.

David Mazzo
David Mazzo
CEO at Lisata Therapeutics

Robert, you there? He must be having connection difficulties.

Operator

All right.

David Mazzo
David Mazzo
CEO at Lisata Therapeutics

We can jump to the next question and-

Robert Sassone
Analyst at Water Tower Research

Hello, sir. Hi.

David Mazzo
David Mazzo
CEO at Lisata Therapeutics

Oh, there you are. Okay. Hello?

Operator

Actually, I'm gonna give Robert a chance to requeue. If you could hit star one one again, I believe, the line. And again, that's star one one. And Robert, your line is open.

Robert Sassone
Analyst at Water Tower Research

Hello?

David Mazzo
David Mazzo
CEO at Lisata Therapeutics

Yes, there you are. Hello, Robert.

Robert Sassone
Analyst at Water Tower Research

Yeah. Sorry, I was on mute, I think. Anyway, I wonder whether you could give us a sort of a rundown, the picture of your, the state of your intellectual property real estate.

David Mazzo
David Mazzo
CEO at Lisata Therapeutics

Sure. So we, you know, we have, we have, a broad intellectual property portfolio that covers certepetide from, you know, composition of matter through method of use, through indication, and, and even, you know, some formulation-type patents. They, they, protect the product into the 2030s, and we have several applications in that are looking to, that are actually currently being prosecuted, that, if granted, could, extend that into the early 2040s. We also would be subject to, patent term extension because of the length of time that certepetide has been in development, and that could also increase the, the patent life by, you know, up to 5 years, as you know, under those laws.

David Mazzo
David Mazzo
CEO at Lisata Therapeutics

And then finally, under the market exclusivity benefits of orphan designations and those indications, we could get market exclusivity independent of the patent situation that extends, you know, 7-10 years, depending on the geography.

Robert Sassone
Analyst at Water Tower Research

Okay. Thanks, that's very useful.

David Mazzo
David Mazzo
CEO at Lisata Therapeutics

Thank you. Mm-hmm.

Operator

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

David Mazzo
David Mazzo
CEO at Lisata Therapeutics

Well, again, thank you for all who are participating today and for joining us on the call. We look forward to speaking with you again during our next quarterly conference call, and to continuing to provide updates on the achievements and progress of Lisata Therapeutics. We remain grateful for your continued interest and support. We wish you a very nice evening.

Operator

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

Executives
    • David Mazzo
      David Mazzo
      CEO
    • James Nisco
      James Nisco
      SVP of Finance and Treasury and Chief Accounting Officer
    • John Menditto
      John Menditto
      VP of Investor Relations and Corporate Communications
    • Kristen Buck
      Kristen Buck
      EVP of Research and Development and CMO
Analysts
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