Lisata Therapeutics Q1 2024 Earnings Call Transcript

Quartr
Provided by Quartr
May 9, 2024

Key Takeaways

  • Operating Efficiency and Cash Runway: Q1 2024 operating expenses decreased 3.6% year-over-year, net loss narrowed to $5.4 M from $6.2 M, and cash of $43.3 M supports operations into early 2026.
  • Regulatory and Commercial Milestones: Certepatide received its official INN/USAN/AAN names and multiple designations (Fast Track, Orphan, Rare Pediatric), positioning it for priority review, accelerated approval and potential voucher awards.
  • ASCEND Phase 2b Progress: Enrollment is complete for the 158-patient trial in metastatic pancreatic cancer, with cohort A top-line data expected in Q4 2024 and full data by mid-2025.
  • BOLSTER Trial Refocus: After terminating unfeasible arms, the study now targets first-line cholangiocarcinoma with enrollment exceeding expectations and completion slated by year-end 2024.
  • Execution Risks in Global Trials: Several investigator-initiated and geographically dispersed studies (e.g., GBM in Estonia/Latvia) could face timing uncertainties due to limited company control.
AI Generated. May Contain Errors.
Earnings Conference Call
Lisata Therapeutics Q1 2024
00:00 / 00:00

Transcript Sections

Skip to Participants
Operator

Welcome to the Lisata Therapeutics First Quarter 2024 Financial Results and Business Update Conference Call. At this time, all participants are in listen-only mode. After the speaker's presentation, there will be a question-and-answer session. To ask a question during this session, you need to press star one one on your telephone. You will then hear an automated message advising your hand is raised. To withdraw your question, please press star 11 again. Please be advised that today's conference is being recorded. I would now like to hand the conference over to our first speaker today, John Menditto, Vice President of Investor Relations and Corporate Communications. Please go ahead.

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 first quarter 2024 conference call to discuss our financial results and to provide a business update. Joining me today from our management team are Dr. David Mazzo, President and Chief Executive Officer, and Dr. Kristen Buck, Executive Vice President of Research and Development and Chief Medical Officer, and James Nisco, Chief Accounting Officer. Shortly before this call, we are going to release announcing our first quarter 2024 financial results, which is available under the Investors and News section of the company website, along with the webcast replay of this call. If you have not received this news release or would like to be added to the company's email distribution list, please email me at jmenditto@lisata.com.

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

Before we begin, I remind you that comments made by management during this conference call will contain forward-looking statements that involve risks and uncertainties regarding the operations and future results of Lisata. I encourage you to review the company's filings with the Securities and Exchange Commission, including, without limitation, its Forms 10-Q, 8-K, and 10-K, which identify specific risk factors that may cause actual results or events to differ materially from those described in the forward-looking statements. Furthermore, the content of this conference call contains time-sensitive information that is accurate only as of the date of this live broadcast, Thursday, May 9th, 2024. Lisata Therapeutics undertakes no obligations to revise or update any statements to reflect events or circumstances after the date of this conference call. With that, I will now turn the call over to Dr. Mazzo. Dave?

David Mazzo
David Mazzo
President and 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 first quarter 2024 financial results, and give an update on the progress of our various development programs. Building on the momentum of 2023, Lisata is off to a very strong start in 2024. We continue to make notable progress developing our lead product candidate, certepetide, formerly known as LSTA1, in combination with a variety of anticancer agents of differing modalities as a treatment for multiple solid tumor cancers. As we have previously reported, encouraging preclinical data as well as early clinical data in humans continue to support our belief that certepetide has the potential to become an integral part of a revised standard-of-care treatment approach for many challenging solid tumors. Dr.

David Mazzo
David Mazzo
President and CEO at Lisata Therapeutics

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. Before getting to the numbers, I want to mention the achievement of another important milestone for Lisata. Certepetide, spelled C-E-R-T-E-P-E-T-I-D-E, is the official International Nonproprietary Name, or INN, United States Adopted Name, or USAN, and Australian Approved Name, or AAN, now formally assigned to LSTA1. INN, USAN, and AAN names are also referred to as generic substance names for pharmaceutical products. Obtaining one of these names is part of the commercial development of a drug and represents an important step along the path to commercialization. Going forward, we will systematically use the name certepetide when referring to our product rather than the internal code of LSTA1 to emphasize the progress being made toward product registration.

David Mazzo
David Mazzo
President and CEO at Lisata Therapeutics

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

James Nisco
James Nisco
Chief Accounting Officer at Lisata Therapeutics

Thanks, Dave. Good afternoon, all. I'm pleased to join you today to present a summary of our first quarter 2024 financial results, starting with operating expenses. For the three months ended March 31st, 2024, operating expenses totaled $6.6 million compared to $6.8 million for the three months ended March 31st, 2023, representing a decrease of $0.2 million or 3.6%. Research and development expenses were approximately $3.2 million for the three months ended March 31st, 2024, compared to $3.2 million for the three months ended March 31st, 2023, representing an essentially unchanged spend. The minor increase of $62,000 or 2% was primarily due to an increase in expenses associated with our enrollment activities in the current year for our certepetide phase II-A proof of concept BOLSTER trial, partially offset by a reduction in expenses associated with the phase II-B ASCEND trial, which completed enrollment in the prior year.

James Nisco
James Nisco
Chief Accounting Officer at Lisata Therapeutics

General and administrative expenses were approximately $3.4 million for the three months ended March 31st, 2024, compared to $3.7 million for the three months ended March 31st, 2023, representing a decrease of $0.3 million or 8.3%. This was primarily due to a decrease in staffing costs associated with the elimination of the Chief Business Officer position on May 1st, 2023, a reduction in option assumption equity expense in connection with the Cend merger, a decrease in directors and officers' insurance premiums, and a reduction in spend on consulting and legal fees, partially offset by one-off settlement-related costs. Overall, net losses were $5.4 million for the three months ended March 31st, 2024, compared to $6.2 million for the three months ended March 31st, 2023. Turning now to our balance sheet and cash flow. As of March 31st, 2024, Lisata had cash, cash equivalents, and marketable securities of approximately $43.3 million.

James Nisco
James Nisco
Chief Accounting Officer at Lisata Therapeutics

Based on our current business and development plans, the company believes that its available capital will fund operations into early 2026, encompassing anticipated data milestones from all its ongoing and currently planned clinical trials. This completes my financial overview, and I will now turn the call over to our Chief Medical Officer, Dr. Kristen Buck, for the review of our clinical development pipeline. Kristen?

Kristen Buck
Kristen Buck
EVP of Research and Development and Chief Medical Officer at Lisata Therapeutics

Thanks, James, and good afternoon, everyone. Lisata's development programs are based on sound scientific rationale from a vast body of published preclinical and early clinical works. These works include those which led to Dr. Erkki Ruoslahti being awarded the Lasker Prize for the fundamental discoveries that spawned our CendR platform technology. A product of the CendR platform, certepetide, is designed to address major impediments to the successful treatment of advanced solid tumors. This is especially relevant in an environment of increasing cancer prevalence and growing pharmacoeconomic pressures. Our clinical studies have been rigorously designed with the end in mind, that is, product registration, and they're optimized to generate clinically meaningful, unambiguous data. As such, unlike many similarly phased studies, our studies are placebo-controlled, appropriately sized, and employ primary endpoints that are preferred by regulatory authorities in support of pivotal trials.

Kristen Buck
Kristen Buck
EVP of Research and Development and Chief Medical Officer at Lisata Therapeutics

Further, our trials evaluate certepetide in combination with current standards of care to allow for clear discernment of treatment effect and to fit with current treatment practices at clinical sites. These strategic design choices are not always the least expensive approach, but they do afford us the most scientifically rigorous methodology by which to generate clinically meaningful data as efficiently and rapidly as possible. This is in keeping with our development mantra, "Do the last experiment first," to avoid the time and capital consumption on work that could become unnecessary. We have also devised and implemented a regulatory strategy that optimizes certepetide's regulatory review and future commercialization. This strategy includes obtaining special regulatory designations, priority reviews, and accelerated approvals.

Kristen Buck
Kristen Buck
EVP of Research and Development and Chief Medical Officer at Lisata Therapeutics

I will speak more to the company's strategy in a moment, but as you can imagine, the aforementioned opportunities underpin why we are so excited about the initial top-line results that we'll report at the end of the year from our large phase II-B ASCEND trial. However, before I get to the specific of each of the clinical studies, allow me to provide some important background, especially for those who are listening to me 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, or brain cancer, and other solid tumors are surrounded by a dense fibrotic tissue known as the stroma, which actually limits access of most pharmacotherapies to the tumor.

Kristen Buck
Kristen Buck
EVP of Research and Development and Chief Medical Officer at Lisata Therapeutics

In addition, many solid tumors also present with a hostile tumor microenvironment, or TME, which suppresses a patient's immune system and makes it less effective in fighting cancer. The combination of the dense stroma and the hostile TME prevents many chemotherapies and immunotherapies from optimally being effective in treating 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. However, to combat this, Lisata's approach is to exploit the CendR rule to activate the CendR active transport system. It's a naturally occurring active transport system to selectively deliver anticancer drugs through the stroma and into the tumor.

Kristen Buck
Kristen Buck
EVP of Research and Development and Chief Medical Officer at Lisata Therapeutics

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, but not healthy tissue. Once bound to these integrins, certepetide is cleaved by proteases naturally occurring in the tumor microenvironment. The proteases convert certepetide from a cyclic peptide into two linear peptides, one of which is a five-amino acid CendR linear peptide fragment. Upon dissociation of the CendR fragment from the integrin receptor, it binds to another receptor called neuropilin-1 on the same or 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.

Kristen Buck
Kristen Buck
EVP of Research and Development and Chief Medical Officer at Lisata Therapeutics

These microvesicles encapsulate moieties in the circulatory system, including any co-administered anticancer drugs, unbound certepetide and CendR fragments, and essentially ferries them through the stroma and vasculature into the tumor. Certepetide's mechanism of action is agnostic to the modality of the companion anticancer drug with which it's administered, and it can be combined with a wide range of existing or emerging anticancer therapies, including chemotherapies, immunotherapies, and RNA-based therapies. Additionally, as previously reported, 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 actually 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.

Kristen Buck
Kristen Buck
EVP of Research and Development and Chief Medical Officer at Lisata Therapeutics

Along with our collaborators, we've also amassed significant nonclinical data demonstrating enhanced delivery of a range of anticancer therapy modalities, including chemotherapies, immunotherapies, RNA-based therapeutics, and even cell therapies. And to date, certepetide has demonstrated favorable clinical safety, tolerability, and activity to enhance delivery of standard-of-care chemotherapy for patients with metastatic pancreatic cancer. As mentioned earlier, Lisata has worked diligently to optimize our regulatory strategy. The fruits of our labor can be seen in the number of special regulatory designations awarded to our product. For example, 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 an accelerated approval and priority review if the relevant criteria are met.

Kristen Buck
Kristen Buck
EVP of Research and Development and Chief Medical Officer at Lisata Therapeutics

Further, certepetide has received multiple orphan designations, including one for pancreatic cancer in both the U.S. and Europe, as well as one for malignant glioma in the United States. Orphan designation affords Lisata exemption from user fees and provides extended market exclusivity. Since the start of 2024, certepetide has also received an orphan designation and a rare pediatric disease designation for osteosarcoma in the United States. Just 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. A substantial benefit of a rare pediatric disease designation is receipt of a priority review voucher, often referred to as the golden ticket, once the FDA approves a new drug application or NDA for the product and indication having received the designation.

Kristen Buck
Kristen Buck
EVP of Research and Development and Chief Medical Officer at Lisata Therapeutics

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 six months. The voucher may be used by a sponsor or sold to another sponsor for their use. Priority review vouchers have sold for as much as $350 million historically and more recently have sold for between $75 million-$100 million. Overall, our development strategy includes the pursuit of a rapid certepetide registration for the treatment of metastatic pancreatic ductal adenocarcinoma, alongside studies which further exploit certepetide's ability to enhance a variety of anticancer treatments in a range of 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.

Kristen Buck
Kristen Buck
EVP of Research and Development and Chief Medical Officer at Lisata Therapeutics

For example, the ASCEND trial. It's a 158-patient, double-blind, placebo-controlled, randomized clinical trial evaluating certepetide in combination with standard-of-care gemcitabine and nab-paclitaxel chemotherapy in patients with metastatic pancreatic ductal adenocarcinoma, often known as mPDAC. The trial's being conducted at 25 sites in Australia and New Zealand, led by the Australasian Gastrointestinal Cancer Trials Group, or AGITG, in collaboration with the NHMRC Clinical Trials Centre at the University of Sydney. The study consists of two cohorts. Cohort A receives a single dose of 3.2 milligrams per kilogram certepetide, essentially simultaneously with standard of care, while Cohort B is identical to Cohort A but with a second dose of 3.2 milligrams per kilogram certepetide given four hours after the first.

Kristen Buck
Kristen Buck
EVP of Research and Development and Chief Medical Officer at Lisata Therapeutics

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 95 patients assigned to Cohort A of the study to be reported in the fourth quarter of this year, and the complete dataset of all 158 patients from the study to be available by mid-2025. The prospect of positive data is encouraging, and we have begun planning the subsequent development steps. For example, we've 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 Cohort A of ASCEND warrants submission of an application for provisional determination, the Australian version of a conditional approval.

Kristen Buck
Kristen Buck
EVP of Research and Development and Chief Medical Officer at Lisata Therapeutics

We expect similar discussions with 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 mPDAC. Next, the BOLSTER trial. The BOLSTER trial is our phase II-A double-blind, placebo-controlled, multicenter, randomized trial in the United States evaluating certepetide in combination with standard of care in first-line cholangiocarcinoma. The BOLSTER trial was originally designed as a phase II three-arm basket trial evaluating certepetide in combination with standards of care for second-line head and neck squamous cell carcinoma, second-line esophageal squamous cell carcinoma, and first-line cholangiocarcinoma.

Kristen Buck
Kristen Buck
EVP of Research and Development and Chief Medical Officer at Lisata Therapeutics

During months of study planning and initiation activities for the head and neck and esophageal cohorts, however, we deemed that these two arms were not feasible to recruit given challenges with country-specific access to consistent standard-of-care drugs and delays in adding these standard-of-care drugs to national formularies. Given these obstacles, the two arms were going to take much longer to complete and be significantly more costly than originally projected. As a result, we took the fiscally responsible but nevertheless difficult decision to terminate these arms. Following that action, we strategically refocused the trial on the first-line cholangiocarcinoma arm. As it relates to this, I'm actually delighted to report that Lisata's internal team has made significant enrollment progress to date that has far exceeded expectations. We expect to easily complete enrollment in first-line cholangiocarcinoma by the end of year, if not substantially sooner.

Kristen Buck
Kristen Buck
EVP of Research and Development and Chief Medical Officer at Lisata Therapeutics

Also, the effectiveness of the sites involved in the first-line cholangiocarcinoma arm, along with the enthusiasm and efficiency of the corresponding investigators, has prompted us to consider initiating a BOLSTER study amendment for patients requiring second-line treatment for their cholangiocarcinoma. To achieve this, we are in active discussions with the FDA and our investigator network and will provide more news on this in the coming weeks and months. Next is the CENDIFOX study. It's a phase I-B/II-A open-label trial in the United States of certepetide in combination with neoadjuvant FOLFIRINOX-based therapies in pancreatic, colon, and appendiceal cancers, and it continues to make study progress with enrollment completion for all three arms expected by the end of this year, 2024. This trial will provide us with pre- and post-treatment biopsy immunoprofiling data, as well as long-term heart outcome data.

Kristen Buck
Kristen Buck
EVP of Research and Development and Chief Medical Officer at Lisata Therapeutics

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 mPDAC. During the 2023 ASCO Annual Meeting, Qilu Pharmaceutical presented an abstract sharing preliminary data from the trial, which corroborated previously reported findings from the phase I-B/II-A trial of certepetide plus gemcitabine and nab-paclitaxel conducted in Australia in patients with metastatic pancreatic cancer. As recently announced, Qilu has begun treating patients in their phase II placebo-controlled trial in mPDAC. The study is planned to take approximately 18 months to complete enrollment, approval, and another 13 months for patient follow-up and data analysis and reporting. In collaboration with our funding partner, WARPNINE, the iLSTA trial is a phase I-B/II-A randomized placebo-controlled, single-blind, single-center safety, early efficacy, and pharmacodynamic trial in Australia.

Kristen Buck
Kristen Buck
EVP of Research and Development and Chief Medical Officer at Lisata Therapeutics

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 PDAC. Enrollment completion is expected in the second half of 2024. iGOLISTA, a phase I-B/II-A proof-of-concept safety and 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, WARPNINE. The inspiration for this study comes from the findings recently published in 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 plus pembrolizumab. The subject initially underwent months of standard-of-care treatments and only achieved a partial response.

Kristen Buck
Kristen Buck
EVP of Research and Development and Chief Medical Officer at Lisata Therapeutics

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 the complete response in February of 2023. We hope to provide an update on timing related to the execution of the iGOLISTA study in the 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. This study is designed as a phase II-A 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 patients with newly diagnosed glioblastoma multiforme. 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.

Kristen Buck
Kristen Buck
EVP of Research and Development and Chief Medical Officer at Lisata Therapeutics

On top of the previously described studies, we're exploring additional trials supporting our general development strategy. However, we remain steadfast in only starting trials that can be funded through to 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 our investigators running these studies, Lisata has limited control, and thus timelines and expectations may be subject to change. That said, we are extremely grateful to the investigators and especially to the patients participating in certepetide clinical trials around the world. For those who are more interested, a more comprehensive description of each trial is available in the appendix section of the corporate presentation on our website.

Kristen Buck
Kristen Buck
EVP of Research and Development and Chief Medical Officer at Lisata Therapeutics

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. Dave?

David Mazzo
David Mazzo
President and CEO at Lisata Therapeutics

Hello. Can you hear me?

Kristen Buck
Kristen Buck
EVP of Research and Development and Chief Medical Officer at Lisata Therapeutics

Yes.

David Mazzo
David Mazzo
President and CEO at Lisata Therapeutics

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

David Mazzo
David Mazzo
President and CEO at Lisata Therapeutics

With that overview, operator, we are ready to take questions.

Operator

Thank you. As a reminder, to ask a question, please press star 11 on your telephone. You will then hear an automated message advising 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. Please stand by while I compile the Q&A roster. Our first question comes from Joseph Pantginis from H.C. Wainwright. Please go ahead.

Analyst at H.C. Wainwright

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

David Mazzo
David Mazzo
President and CEO at Lisata Therapeutics

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

Kristen Buck
Kristen Buck
EVP of Research and Development and Chief Medical Officer at Lisata Therapeutics

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

Analyst at H.C. Wainwright

Okay. Great. Thank you. That's helpful.

Operator

Thank you. One moment for our next question. Our next question comes from Will Hidell from Brookline Capital Markets. Please go ahead.

Will Hidell
Equity Research Associate at Brookline Capital Markets

Hi. Thank you for taking questions. I had a quick question regarding the trial with Qilu. Why would they need 18 months?

Operator

Will?

Will Hidell
Equity Research Associate at Brookline Capital Markets

Oh.

David Mazzo
David Mazzo
President and CEO at Lisata Therapeutics

We can hear you. Go ahead, Will.

Will Hidell
Equity Research Associate at Brookline Capital Markets

Can you hear me now?

David Mazzo
David Mazzo
President and CEO at Lisata Therapeutics

Yes. Go ahead.

Will Hidell
Equity Research Associate at Brookline Capital Markets

Okay. Sorry. Hi. Thank you for taking questions.

Operator

Will, if you could mute yourself.

David Mazzo
David Mazzo
President and CEO at Lisata Therapeutics

No, we can hear him, operator.

Will Hidell
Equity Research Associate at Brookline Capital Markets

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

David Mazzo
David Mazzo
President and CEO at Lisata Therapeutics

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

Will Hidell
Equity Research Associate at Brookline Capital Markets

Okay. Thank you.

Kristen Buck
Kristen Buck
EVP of Research and Development and Chief Medical Officer at Lisata Therapeutics

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

David Mazzo
David Mazzo
President and CEO at Lisata Therapeutics

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

Analyst

This is Peter Enderlin. Can you hear me?

David Mazzo
David Mazzo
President and CEO at Lisata Therapeutics

Go ahead, Pete. Yes. Thanks.

Analyst

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

David Mazzo
David Mazzo
President and CEO at Lisata Therapeutics

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

Analyst

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

David Mazzo
David Mazzo
President and CEO at Lisata Therapeutics

All right. So thanks, Pete. I appreciate the question. So first of all, whenever we do and frankly, I think this is true across the entire pharmaceutical industry. Whenever anyone does a trial with international sites, they all work under the same protocol. Otherwise, it would be different trials. So everybody's working under the same protocol no matter where they're enrolling. And the reason that we enroll internationally for certain studies is to be able to acquire patients more readily and to get a broader demographic population, which is typically something that's required in later-stage studies. In case of our BOLSTER trial actually, BOLSTER's running in the United States alone right now. We've enrolled cholangiocarcinoma solely in the United States, and we plan to do the second-line study solely in the United States. ASCEND is running in Australia, New Zealand, and the GBM trial is running in Estonia and Latvia.

David Mazzo
David Mazzo
President and CEO at Lisata Therapeutics

Some of our other trials are looking at sites around the world as well. But it's mostly, again, to take advantage of patient prevalence and sometimes to actually get lower costs rather than higher costs, as you suggested.

Analyst

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

David Mazzo
David Mazzo
President and CEO at Lisata Therapeutics

Yeah. And the European Union, the EMA as well.

Analyst

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

David Mazzo
David Mazzo
President and CEO at Lisata Therapeutics

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

Analyst

Okay. Thanks for clarifying that.

David Mazzo
David Mazzo
President and CEO at Lisata Therapeutics

Sure.

Operator

One moment for our next question. Our next question comes from Steve Brozak from WBB Securities. Please go ahead.

Steve Brozak
Steve Brozak
CEO and Managing Partner at WBB Securities

Hey. Good afternoon, David. Thanks for taking all these questions. I'm going to go back on the finance side. You've obviously focused on making sure that you have funding for as long as possible through 2026. And you just mentioned that I think Kristen just mentioned the potential for getting a voucher after successful completion of the trial. But there's one question I've got for you because you've got all these patients you're treating, and they are very, very ill patients. At the end of the day, you're going to be dealing with patients who have undergone quite a bit of therapeutic treatment at a very, very high cost. Excuse me. Can you give us any sense? I'm not asking you to go out there and tell you what certepetide is going to cost or be charged, but what are these patients what is the system currently paying for?

Steve Brozak
Steve Brozak
CEO and Managing Partner at WBB Securities

It can be an order of magnitude. Paying for these patients who are currently being treated standard of care in a ballpark, please, and just in the United States because, obviously, different countries have different cost parameters. What are your thoughts there? And I've got one follow-up afterwards, please. Thank you.

David Mazzo
David Mazzo
President and CEO at Lisata Therapeutics

Right. Right. So for that, well, thanks for the question, Steve. I appreciate you being on. In the United States and, in fact, in many other countries around the world, the current standard of care for pancreatic cancer is chemotherapy, and it falls pretty evenly distributed between two regimens. One is a combination of gemcitabine, nab-paclitaxel, and nab-paclitaxel is also known as Abraxane. And the other is FOLFIRINOX. And these chemotherapeutics, they're actually generic right now, and they're covered by insurance generally for all these people. So I don't know the exact cost off the top of my head, but the fact is that the introduction of new therapies, like immunotherapies, which are much more costly, is being readily absorbed by these patients because they have such dire circumstances and they're seriously looking for other things.

David Mazzo
David Mazzo
President and CEO at Lisata Therapeutics

Just to give you a ballpark, a typical regimen of gemcitabine, nab-paclitaxel is around $60,000. So that gives you some sense. And our product is, as Kristen, I think, so eloquently described, is simply a small cyclic peptide. It's not as inexpensive to make as a small chemical entity, but it's made by solid-state chemistry that's pretty well standardized these days. And so it's expected to have a cost that will be very reasonable, especially in comparison to the costs of immunotherapies and some of the CAR-T cell therapies, which can cost hundreds of thousands of dollars or even millions of dollars. I hope that gives you a better idea, Steve.

Steve Brozak
Steve Brozak
CEO and Managing Partner at WBB Securities

No, no, no. That's exactly what I was looking for. You touched on the critical matter of all these immunotherapies that are out there and that are, frankly, not seeing the results that you're looking for. So if you're looking at that and because, unfortunately, you're seeing these patients who are so late-stage, especially in pancreatic cancer, I would imagine that this would be something we're looking at for positive results, but this would be looked at as something that is providing for a change of standard of care going forward. So going back to not just the benefit of a voucher, you're looking at a situation where you would actually be you would actually be providing a quality care that is not seen today. Is that an accurate statement? And please fill in anything else, and I'll hop back in the queue. Thank you.

David Mazzo
David Mazzo
President and CEO at Lisata Therapeutics

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

Steve Brozak
Steve Brozak
CEO and Managing Partner at WBB Securities

Great. Let me hop back in the queue, and thanks again for taking the questions.

Operator

Thank you. One moment for our next question. Our next question comes from Robert Sassoon from Water Tower Research. Please go ahead.

Robert Sassoon
Senior Research Analyst at Water Tower Research

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

David Mazzo
David Mazzo
President and CEO at Lisata Therapeutics

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

Kristen Buck
Kristen Buck
EVP of Research and Development and Chief Medical Officer at Lisata Therapeutics

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

Robert Sassoon
Senior Research Analyst at Water Tower Research

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

David Mazzo
David Mazzo
President and CEO at Lisata Therapeutics

Well, we have an activity line, and the timeline is dependent on Qilu's execution. But we do have milestone payments that will be paid for completion of activities such as technology transfer for manufacturing and for initiating phase III and ultimately for registration. Now, they've just started phase II as we announced a couple of weeks ago, and we imagine it'll take a while for them to get through phase II and to get to phase III. But there is always the possibility that the results in China will be so good that they could convince the Chinese regulatory authorities that this phase II trial could become the basis of a provisional application. And I think under those circumstances, that would qualify for the pivotal trial, and we could get a milestone along those lines as well.

David Mazzo
David Mazzo
President and CEO at Lisata Therapeutics

Can't really speak to timing, but certainly, over the course of the next several years, we would expect to collect some milestones from Qilu.

Robert Sassoon
Senior Research Analyst at Water Tower Research

Okay. Thanks. Thanks very much. I'll jump back in the queue.

David Mazzo
David Mazzo
President and CEO at Lisata Therapeutics

Thank you.

Operator

Thank you. As a reminder, to ask a question, please press star one one on your telephone. One moment for our next question. Our next question comes from Robert LeBoyer from Noble Capital Markets. Please go ahead.

Robert LeBoyer
Robert LeBoyer
Senior Biotechnology Analyst at Noble Capital Markets

Well, first, congratulations on all the progress. In Dr. Buck's summary, I heard it was a very good, comprehensive summary, but one of the things that I didn't catch was whether the BOLSTER trial will be announcing data in 2025 or if there were any timelines for BOLSTER or CENDIFOX. I caught the expected completion by the end of the year but didn't hear anything about the expected data release.

David Mazzo
David Mazzo
President and CEO at Lisata Therapeutics

Thanks, Rob. Appreciate the question. Thanks for being on the call as well. All of our trials, as Kristen pointed out, are designed to reach data before our current cash outdate. We're currently funded through early 2026, and everything is designed at this point in order to reach data before that. I would expect that with a BOLSTER trial current target of approximately end of year for completion of enrollment, we should certainly be announcing data before the end of the year next year. As Kristen pointed out, we could be completing enrollment in BOLSTER a lot sooner than that, which would just bring forward the data announcement in 2025.

Robert LeBoyer
Robert LeBoyer
Senior Biotechnology Analyst at Noble Capital Markets

Okay. Great. Thank you very much.

Operator

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

David Mazzo
David Mazzo
President and CEO at Lisata Therapeutics

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

Operator

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

Executives
    • David Mazzo
      David Mazzo
      President and CEO
    • James Nisco
      James Nisco
      Chief Accounting Officer
    • John Menditto
      John Menditto
      VP of Investor Relations and Corporate Communications
    • Kristen Buck
      Kristen Buck
      EVP of Research and Development and Chief Medical Officer
Analysts
Powered by Quartr