Lisata Therapeutics, Inc. (NASDAQ:LSTA) Q2 2023 Earnings Call Transcript

Lisata Therapeutics, Inc. (NASDAQ:LSTA) Q2 2023 Earnings Call Transcript August 17, 2023

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

John Menditto: Thank you, operator, and good morning, everyone. Welcome to Lisata’s Second Quarter 2023 Conference Call to discuss our financial results and the opportunity to provide a business update. Joining me today from our management team are Dr. David Mazzo, President and Chief Executive Officer; Dr. Kristen Buck, Executive Vice President of Research & Development and Chief Medical Officer; and James Nisco, Vice President of Finance and Treasury. Yesterday, Monday, August 14, we issued a press release aftermarket trading closed announcing our second quarter 2023 financial results, which is available under the Investors and News section of the Company website along with the webcast replay of this call. If you have not received the news release or if you’d like to be added to the Company’s e-mail distribution list, please e-mail me at jmenditto@lisata.com.

Before we begin, I remind you that comments made by management during this conference call will contain forward-looking statements that involve risks and uncertainties regarding the operations and future results of Lisata. I encourage you to review the Company’s filings with the Securities and Exchange Commission, including, without limitation, its forms 10-Q, 8-K and 10-K, which identify specific risk factors that may cause actual results or events to differ materially from those described in the forward-looking statements. Furthermore, the content of this conference call contains time-sensitive information that is accurate only as of the date of this live broadcast, Tuesday, August 15, 2023. Lisata undertakes no obligation to revise or update any statements to reflect events or circumstances after the date of this conference call.

With that, I’ll now turn the call over to Dr. Mazzo. Dave?

Dr. David Mazzo: Thank you, John, and good morning, everyone. Thank you for joining us today as we provide an overview of recent business highlights, discuss our second quarter 2023 financial results and give an update on the progress of our various development programs. I’m kicking off today’s call with a heightened sense of excitement and optimism for the future of Lisata. During the second quarter, we continued the advancement of our clinical development programs for the treatment of advanced solid tumors. As those familiar with the Company know, Lisata is a clinical-stage pharmaceutical company focused on the development of a novel solid tumor targeting and penetration technology to improve the efficacy of anticancer drugs.

Our development portfolio contains programs that are designed to bring significant therapeutic improvements in the treatment of solid tumors in a pharmacoeconomically attractive paradigm. LSTA1, our lead product candidate is the subject of multiple planned and ongoing clinical trials being conducted globally in a variety of solid tumor types and in combination with multiple anticancer agents of different modalities. Based on substantial preclinical and most importantly, early clinical data in humans, we believe that LSTA1 has the potential to become an integral part of a revised standard of care treatment regimen for many difficult-to-treat cancers. During this call, our Chief Medical Officer, Dr. Kristen Buck, will provide more specifics on our clinical programs following our review of financial results.

However, before moving on to the financial and clinical overview, we are pleased to announce a significant milestone in the form of a technology transfer agreement of our tumor penetrating nanocomplex, or TPN, platform with Impilo Therapeutics, Inc., a recently formed company, led by David Slack, former Lisata Chief Business Officer. The TPN platform targets intracellular delivery of RNA-based drugs to prevent solid tumor growth. TPN is designed so that it not only binds to proteins overexpressed on the surface of human cancer cells but also passes through the membrane by way of a cell-penetrating peptide. Once inside the cells, the TPN is expected to release an RNA-based drug directed against the tumor. The noted technology transfer will place the TPN technology in the capable hands of the team with profound expertise in RNA-based therapeutics development, further enhancing its potential impact in the field.

Under the terms of the technology transfer agreement upon closing Lisata will receive an equity stake in Impilo Therapeutics. Lisata will also receive a seat on Impilo’s Board of Directors, but is not obliged to commit any capital or additional resources to the program’s future development. With that, I now will turn the call over to James Nisco, our Vice President of Finance and Treasury, to review and provide commentary on our financial results. James?

James Nisco: Thanks, Dave. Good morning all. I’m pleased to join you today to present a summary of our second quarter 2023 financial results. Starting with operating expenses. Research & development expenses remained constant at approximately $3.2 million for the three months ended June 30, 2023, and three months ended June 30, 2022. The Expenses this quarter were primarily due to study start-up activities associated with the LSTA1 BOLSTER trial, enrollment activities for the LSTA1-ASCEND study and chemistry, manufacturing and control activities for LSTA1 to support all development activities. General and administrative expenses were approximately $3.7 million for the three months ended June 30, 2023, compared to $3.5 million for the three months ended June 30, 2022, representing an increase of $0.2 million or 6.5%.

This was primarily due to severance costs associated with the elimination of the Chief Business Officer position on May 1, 2023, partially offset by non-recurring merger related costs in the prior year. Overall, net losses were $4 million for the three months ended June 30, 2023, and compared to $6.6 million for the three months ended June 30, 2022, a decrease of approximately 40%, primarily due to $2.2 million in non-dilutive funding received as an approved participant of the Technology Business Tax Certificate Transfer program sponsored by the New Jersey Economic Development Authority. Turning now to our balance sheet and cash flow. As of June 30, 2023, the Company had cash, cash equivalents and marketable securities of approximately $57.6 million.

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The Company is confident that its projected capital will fund its current proposed operations into the first quarter of 2026, encompassing anticipated data milestones from all its ongoing and planned clinical trials. This completes my financial overview, and I will now turn the call over to our Chief Medical Officer, Dr. Kristen Buck for the review of our clinical development pipeline. Kristen?

Dr. Kristen Buck: Thank you, James, and good morning, everyone. As those that follow us know, Lisata’s pipeline is built on a portfolio of proprietary and patented technology that is grounded in strong scientific rationale and a body of published preclinical and early clinical data. Our platform technology is designed to address major impediments to the successful treatment of advanced solid tumors in the context of increasing pharmacoeconomic pressures on the health care system. We appreciate the critical importance of generating meaningful clinical data to advance our platform technology, and I can assure you that our entire organization has this goal top of mind in everything we do. With that, I will now provide an overview of our lead product candidate, LSTA1, LSTA1, for the treatment of advanced solid tumors in combination with other anticancer agents.

Despite advances in cancer therapy today, many solid tumors remain difficult to effectively treat. Cancers, such as pancreatic cancer, gastric cancers and other solid tumor cancers are surrounded by a dense fibrotic tissue known as the Stroma, which limit the access of most pharmacotherapies to the tumor. Many tumors also exhibit a hostile tumor microenvironment, or TME, which suppresses the patient’s immune system and makes it less effective in fighting cancer. The combination of dense stroma on a hostile tumor microenvironment negatively impacts the ability of many cytotoxic agents and immunotherapies to effectively treat these cancers. This coupled with the fact that most anticancer therapies are not efficient in targeting only cancer tissue defines the major challenge of maximizing effectiveness and safety in the treatment of solid tumors.

To combat this, Lisata’s approach is to activate the C-end rule, or CendR system, a naturally occurring active transport system to selectively deliver anticancer drugs through the stroma and into the tumor. Lisata’s lead product candidate, LSTA1 is an investigational drug that actuates the CendR active transport mechanism while also having the potential to modify the tumor microenvironment and make it less immunosuppressive. LSTA1 targets tumor vascular endothelial cells as well as tumor cells themselves based on its affinity for alpha v beta three and beta five integrins that are upregulated on these cells but not on healthy tissue. LSTA1 is a 9-amino acid cyclic internalizing RGD peptides that once found in these integrins, is cleaved by protease.

Protease is expressed in the tumor microenvironment to release a peptide fragment called the CendR Fragment. The CendR 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 Cend C-end rule active transport pathway and bury anticancer drugs more efficiently into solid tumors. Additionally, LSTA1 one 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 anticancer drugs used against solid tumors. These results come internally from Lisata 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 nonclinical data, demonstrating enhanced delivery of a range of emerging anticancer therapy, including immunotherapy and RNA-based therapeutics. Clinically, LSTA1 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 LSTA1 to enhance a variety of anticancer treatment modality in a range of solid tumors. Currently, LSTA1 is the subject of about a dozen plans for 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 patients, double-blind, randomized, placebo-controlled clinical trial evaluating LSTA1 in combination with gemcitabine and nab-paclitaxel 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 Gastro-Intestinal 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, Warpnine treated our first five patients in the iLSTA1 trial in Australia, evaluating LSTA1 in combination with standard of care chemotherapy that is gemcitabine and nab-paclitaxel chemotherapy and immunotherapy using durvalumab as a first-line treatment in locally advanced non-resectable pancreatic ductal adenocarcinoma.

This is the first of several planned trials in which we are expanding the study of LSTA1’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 LSTA1 is a Phase IIa placebo-controlled basket trial in the United States, Europe, Canada and Asia, evaluating LSTA1 in combination with standards of care in solid tumors, including head and neck, esophageal and cholangiocarcinoma. This trial includes both cytotoxins 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 studies within about one month. Once this requirement — this required component of Bolsters protocol is at the investigational sites, we look much forward to announcing the first patient treated in the cholangiocarcinoma arm. Next is the CENDIFOX trial, a Phase Ib/IIa open-label trial of LSTA1 in combination with neoadjuvant folfirinox 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 readout in 2024. This trial will provide us with post treatment biopsy immuno-profiling data as well as long-term outcome data. LSTA1 is also currently being evaluated in combination with gemcitabine and nab-paclitaxel in a Phase Ib/IIa open trial — open-label trial in China, led by our licensee in that territory, Qilu Pharmaceutical. During the 2023 ASCO Annual Meeting, Qilu Pharmaceutical presented an abstract during preliminary data from the study, which corroborated previously reported findings from the Phase Ib/IIa trial of LSTA1 plus gemcitabine and nab-paclitaxel conducted in Australia in patients with metastatic pancreatic ductal adenocarcinoma.

Final data are expected by the end of the second quarter of 2024. iGoLSTA, a Phase Ib/IIa proof-of-concept, safety and early efficacy studies, evaluating LSTA1 in combination with nivolumab and FOLFIRINOX 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, WARPNINE. We hope to have further update 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 LSTA1 in combination with temozolomide in Glioblastoma Multiforme, commonly known as GBM.

This study is designed as a Phase IIa double-blind, placebo-controlled randomized proof-of-concept study evaluating LSTA1 when added to standard of care Temozolomide versus temozolomide and matching LSTA1 placebo in patients with newly diagnosed Glioblastoma Multiform. It will be conducted across multiple sites in Estonia and Latvia, and it is targeted to enroll 30 patients with the randomization of 2:1, LSTA1 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, LSTA1 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 need but also recognizes the potential of LSTA1 to benefit patients in this indication.

Lastly, we are planning to study LSTA1 in combination with hyperthermic intraperitoneal chemotherapy or 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 I single-center unblinded randomized controlled trial to determine the safety and tolerability of LSTA1, administer intraperitoneal in patients with currently on metastasis for colorectal, appendiceal or ovarian cancer undergoing cytoreductive surgery and HIPEC. 21 total patients will be randomized 2:1 to receive LSTA1 with HIPEC versus HIPEC alone after cytoreduction surgery.

We anticipate that this study will also be up and running in the fourth quarter of 2023 and the first patient being treated shortly thereafter. For those who are interested, a more complete description of our trials is available in the Appendix section on the corporate presentation on our website. Additionally, in the body of the presentation, there are two milestone slides that displays the anticipated timing of key execution milestones and data readouts for the clients. With that, I will now turn the call back to Dave.

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Q&A Session

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

And with that overview, operator, we’re now ready to take questions.

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

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

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

Operator: We have a question from Steve Brozak with WBB Securities.

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

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