Earnings Call Transcript - LSTA Q1 2023

Operator, Operator

Welcome to the Lisata Therapeutics First Quarter 2023 Financial Results and Business Update Conference Call. Currently all participants are in listen-only mode. As a reminder, this call is being recorded today, Tuesday, May 9, 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, Vice President of Investor Relations and Corporate Communications

Thank you, operator, and good afternoon, everyone. Welcome to Lisata's first 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, Chief Executive Officer; Dr. Kristen Buck, Executive Vice President of Research and Development and Chief Medical Officer; and James Nisco, Vice President of Finance and Treasury. Shortly before this call, we issued a press release announcing our first quarter 2023 financial results, which is available under the Investors & News section of the company website, along with the 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 e-mail distribution list, please email me. Before we begin, I remind you that comments made by management during this conference call will contain forward-looking statements and 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 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, May 9, 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 will now turn the call over to Dr. Mazzo. Dave? Dave, I believe you may be on mute.

David Mazzo, Chief Executive Officer

There we are. We're having technical difficulties today. My apologies, everyone. And thank you, John, for the introduction. And good afternoon, everyone, and thank you once again for joining us as we provide an overview of recent business highlights, discuss our first quarter 2023 financial results and give an update on the progress of our various development programs. During the first quarter, the vast majority of our efforts remained focused on the advancement of our clinical development programs for the treatment of advanced solid tumors. As those who follow us now know, Lisata is a clinical-stage therapeutic development company with 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 improvement 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 human clinical data, 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. Our Chief Medical Officer, Dr. Kristen Buck, shortly will provide more specifics on our clinical programs following our review of financial results. However, before we get to those subjects, I will take a moment to elaborate on the organizational change that we announced last week. Operating a sustainable clinical-stage biopharmaceutical business involves constant vigilance of capital utilization and often difficult decisions by management teams and Boards of Directors involving programs and people. The need for scrutiny of resource allocation has become even more acute in the volatile and unpredictable capital markets environment of today and that may exist for the foreseeable future. With that in mind and coupled with our operational imperative to ensure that we have sufficient capital to reach important data milestones for all our clinical development programs, we’ve recently implemented a number of capital-preserving measures based on an updated review of business priorities and capital allotment. Among the measures that were enacted was the streamlining of our organization at the non-executive and executive levels. As part of this organization optimization, the position of President and Chief Business Officer was eliminated, and David Slack's employment with the company was ended. On a personal level, we are saddened to see David's departure from Lisata. And I will take this opportunity to publicly acknowledge his many contributions to the evolution of Cend Therapeutics and the transaction that formed Lisata. David was instrumental in leading the efforts to identify a means by which to exploit the promise of LSTA1 in a comprehensive clinical development program as he was in the licensing deal of LSTA1 with our Chinese partner, Qilu Pharmaceutical. We are grateful for his past contributions and wish him well in the future. And with that, I now will turn the call over to James Nisco, our VP of Finance and Treasury, to review and provide commentary on our financial results. James?

James Nisco, Vice President of Finance and Treasury

Thanks, Dave. Good afternoon all. I'm pleased to join you today to present a summary of our first quarter 2023 financial results. Starting with operating expenses. Research and development expenses were approximately $3.2 million for the three months ended March 31, 2023, compared to $3.3 million for the three months ended March 31, 2022, representing a decrease of $0.1 million or 3.2%. This was primarily due to expenses associated with our XOWNA Phase IIb study, the FREEDOM Trial, in the prior year, partially offset by study start-up activities in the current year associated with the planned Phase II proof-of-concept BOLSTER Trial studying LSTA1 in various solid tumors in combination with the corresponding standards of care. Enrollment activities for the LSTA1 Phase IIb ASCEND study and chemistry and manufacturing and control activities for LSTA1. General and administrative expenses were approximately $3.7 million for the three months ended March 31, 2023, compared to $3.3 million for the three months ended March 31, 2022, representing an increase of $0.3 million or 9.8%. This was primarily due to the addition of one employee acquired through the merger with Cend Therapeutics, an increase in external legal fees and an increase in accounting and tax-related fees. Overall, net losses were $6.2 million for the three months ended March 31, 2023, compared to $4.2 million for the three months ended March 31, 2022. Turning now to our balance sheet and cash flow. As of March 31, 2023, the company had cash, cash equivalents and marketable securities of approximately $61.1 million. These figures do not include the recently announced $2.2 million in non-dilutive funding that we received as an approved participant of the Technology Business Tax Certificate Transfer Program sponsored by the New Jersey Economic Development Authority, which will be recorded in the second quarter of 2023. As we have reported previously, the program enables qualifying New Jersey-based biotechnology companies to sell a percentage of their New Jersey net operating losses and research and development tax credits to unrelated qualifying corporations. With several operational initiatives underway that will help manage external costs and, as Dave mentioned, the elimination of the President and Chief Business Officer position, we now project that our current available capital should take us into the first quarter of 2026, encompassing anticipated data milestones from all of our ongoing and planned clinical studies. 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, Chief Medical Officer

Thank you, James, and good afternoon, everyone. While we recently discussed our programs during our full year 2022 results call, I think it's essential to keep our stakeholders updated on the ongoing progress of the Lisata team. Lisata’s pipeline is supported by proprietary and patented technology founded on solid scientific principles and a wealth of published preclinical and early clinical data. Our technologies aim to tackle significant challenges in effectively treating solid tumors, especially considering the rising pharmacoeconomic pressures on the healthcare system. We understand the critical need for generating meaningful clinical data to advance our platform technology, and I assure you that this focus is a priority for our entire organization. Now, I'll summarize the current status of each of Lisata's active clinical development programs, starting with our lead product candidate, LSTA1, which targets advanced solid tumors in conjunction with other anticancer agents. Despite advancements in cancer treatments, many solid tumors continue to be challenging to treat effectively. Cancers like pancreatic and gastric cancer are often enveloped by dense fibrotic tissue known as stroma, limiting most pharmacotherapies' access to the tumor itself. Additionally, many tumors create a hostile tumor microenvironment that undermines a patient’s immune response, making it even harder to fight cancer. This combination of dense stroma and an unwelcoming microenvironment significantly hinders the effectiveness of many cytotoxic agents and immunotherapies. Moreover, most anticancer therapies do not efficiently target cancerous tissue, which presents a significant obstacle in optimizing treatment effectiveness and safety for solid tumors. To address this, Lisata’s strategy involves activating the C-end Rule or CendR system, a natural active transport mechanism to selectively deliver anticancer drugs through the stroma directly into the tumor. Our lead candidate, LSTA1, is an investigational drug that triggers this CendR transport system and has the potential to modify the tumor microenvironment to reduce its immunosuppressive qualities. LSTA1 targets tumor vascular endothelial cells and the tumor cells themselves due to its affinity for alpha-v beta 3 and beta 5 integrins, present on these cells but not typically on healthy tissue. LSTA1 is a cyclic RGD peptide made up of nine amino acids that binds to these integrins, where it is cleaved by proteases in the tumor microenvironment to release a fragment known as CendR. This fragment binds to an adjacent receptor called neuropilin-1, which is also upregulated on tumor cells to activate the CendR transport pathway, delivering anticancer drugs more efficiently into solid tumors. Furthermore, LSTA1 has demonstrated through various preclinical models its ability to alter the tumor microenvironment, making it less hostile to immune cells and enhancing the efficacy of anticancer drugs. These findings originate from both Lisata and our global collaborators, resulting in over 200 scientific publications. Alongside our partners, we have collected substantial non-clinical data showing improved delivery of emerging anticancer therapies, including immunotherapies and RNA-based treatments. Clinically, LSTA1 has shown favorable safety, tolerability, and efficacy in enhancing the delivery of standard chemotherapy for metastatic pancreatic cancer patients. Our development programs aim to leverage LSTA1's potential to enhance various anticancer treatment modalities across multiple solid tumors. Currently, LSTA1 is involved in approximately a dozen active or planned clinical trials worldwide targeting various solid tumors. Let’s discuss a few of these trials. First, the ASCEND trial is a 155-patient double-blind, randomized, placebo-controlled trial assessing LSTA1 in conjunction with gemcitabine and nab-paclitaxel for patients with metastatic pancreatic ductal adenocarcinoma. This study is being conducted at about 40 sites across Australia and New Zealand, led by the Australasian Gastro-Intestinal Cancer Trials Group. We are pleased with AGITG's progress, and patient enrollment is going well. Initially, we anticipated completing enrollment by Q2 2024, but if current rates continue, we may finish sooner. Recently, with our clinical research partner WARPNINE, we treated our first two patients in the iLSTA trial in Australia, testing LSTA1 alongside standard care gemcitabine and nab-paclitaxel chemotherapy, and the immunotherapy durvalumab for first-line treatment in locally advanced, non-resectable pancreatic ductal adenocarcinoma. This marks the beginning of several trials intended to explore LSTA1's effect on existing therapies by incorporating immunotherapies. We also expect to complete enrollment for this trial by Q2 2024. Next is CENDIFOX, a Phase Ib/IIa open-label trial of LSTA1 combined with neoadjuvant FOLFIRINOX in pancreatic, colon, and appendiceal cancers, which continues to progress, with enrollment completion anticipated by the end of this year and data results expected in 2024. This trial will yield post-treatment biopsy data for immunoprofiling, as well as long-term outcome information. Additionally, LSTA1 is undergoing evaluation with gemcitabine and nab-paclitaxel in a Phase Ib/IIa open-label trial in China led by our local licensee, Qilu Pharmaceutical. Preliminary data on progression-free survival is anticipated to be shared at the upcoming ASCO Meeting in June. The BOLSTER Trial involves LSTA1 in a Phase II placebo-controlled basket trial looking at advanced solid tumors, including head and neck, esophageal, and cholangiocarcinoma, in conjunction with standards of care. We are excited to report that this trial is now active, and we hope to announce the enrollment of the first patient by the end of Q2. Finally, the iGoLSTA study, a Phase Ib/IIa proof-of-concept trial assessing LSTA1 alongside nivolumab and FOLFIRINOX for first-line treatment in locally advanced nonresectable gastroesophageal adenocarcinoma, is set to start in Q3 of this year. In addition to these trials, we plan to initiate others in the next few months, including LSTA1 with temozolomide for glioblastoma multiforme and LSTA1 combined with HIPEC for patients with peritoneal carcinomatosis. For those interested, detailed descriptions of each trial can be found in the appendix of our corporate presentation on our website, and additional slides in the presentation outline the expected timeline for data readouts from our trials. Moving on to LSTA12, known as HONEDRA in Japan, which targets critical limb ischemia and Buerger’s disease. HONEDRA holds SAKIGAKE designation in Japan. We have completed a registration-eligible study for HONEDRA, and the data from this study have informed our pre-consultation and subsequent consultation with Japanese regulatory authorities regarding the next steps for the program. So far, the PMDA has given us guidance on preparing for the formal consultation meeting and indicated a preference for more clinical information to accompany the filing of a JNDA. Consequently, we are evaluating our next steps and have engaged a specialized firm to help us secure a Japanese partner to complete the remaining development and registration steps, as well as commercialization efforts in Japan. Lastly, LSTA201, targeting diabetic kidney disease. In 2022, we launched a Phase Ib open-label proof-of-concept trial for LSTA201, a CD34+ regenerative cell therapy given through intrarenal artery administration in diabetic kidney disease patients. This study aimed to assess how well patients tolerated the intrarenal injection and whether LSTA201 could help regenerate kidney function. We previously reported on February 6, 2023, that the preliminary results showed LSTA201 was safe and well tolerated, with no serious adverse events reported. However, there was no consistent improvement in kidney function across all patients. Despite this, feedback from the principal investigator and key opinion leaders suggested there may still be potential for using CD34+ cell therapy in treating diabetic kidney disease. Future development of LSTA201 will require significantly larger studies and investment, so Lisata will continue development only if a strategic partner willing to provide the necessary capital is found.

David Mazzo, Chief Executive Officer

Thanks, Kristen. As Kristen has outlined, the Lisata team is making continual progress advancing our development programs with the goal of maximizing the potential of our development pipeline. 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. We are excited by the promise of our platform technology and are committed to achieving meaningful data readouts as soon as possible with the goal of benefiting patients, the physicians who treat them and our shareholders. And with that, operator, we're now ready to take questions.

Operator, Operator

Our first question comes from Steve Brozak with WBB Securities. Your line is open.

Steve Brozak, Analyst

Yes, hi. Thanks for taking the question. In listening to the list of trial approaches, I'm seeing that everything is really adding to the current standard of care in all of these critical indications. What kind of feedback are you getting from your clinician partners that you're working with on what they're seeing, the importance and how this basically works into what they've done in the past? And I'll hop back in the queue after that. Thank you.

David Mazzo, Chief Executive Officer

Thanks, Steve. Nice to talk to you. And I appreciate your question. So before we started these trials, Kristen spent a good deal of time talking to key opinion leaders, influential practicing oncologists throughout the country and, in fact, throughout the world to get their feedback on where the highest unmet medical needs were, which solid tumors were the ones where we could make the biggest difference and whether or not they felt that the approach that we were espousing actually was sensible to them. The feedback that we got then which led to the initiation of these trials and the feedback that we continue to get is that the clinicians are extremely enthusiastic about the prospect of taking existing standards of care and actually making them optimized, making them work maximally in terms of efficacy without causing any further detrimental safety issues. They think that this is an approach that will be faster to conclusion, faster eventually to potential market and faster to patients in the long run than brand-new NCEs that have to start developing an efficacy profile from scratch. And they also believe that in this pharmacoeconomically challenging environment where the Inflation Reduction Act and other pressures are putting increased scrutiny into drug prices and looking for ways to introduce innovation in a cost-effective manner, the ability to take something as simple as a small cyclic peptide and use it to significantly augment the efficacy of known drugs, many of which are already generic or will be generic, seems to make a lot of sense to them. And of course, our trials are mostly blinded, so they can't see any specific results per se, but there's a strong sentiment among them that LSTA1 is doing exactly what we reported it would do.

Steve Brozak, Analyst

Can I tack on one addendum? On the regulatory side, given the fact that obviously it's one of the considerable hurdles in these spaces, what do you see there in terms of the advantage? And again, this time, I will hop back in the queue.

David Mazzo, Chief Executive Officer

The regulatory advantages are quite clear. By simply co-administering these products into an existing regimen, we avoid complex mixing since the only interaction occurs within the body. This simplifies formulation and stability, as well as chemistry and manufacturing control issues. We are not dealing with new chemical entities, which means extensive preclinical work is unnecessary, and separate toxicology assessments for these new entities are not required. Furthermore, LSTA1 is very safe, making predictions straightforward. We have had positive interactions with the FDA, the TGA in Australia, and have begun discussions with the EMA in Europe, with no significant obstacles encountered thus far, and the conversations are progressing as anticipated.

Steve Brozak, Analyst

Got it. Again, thanks for taking the questions. And let me hop back in the queue.

David Mazzo, Chief Executive Officer

Thanks, Steve.

Operator, Operator

Thank you. Our next question comes from Kemp Dolliver with Brookline Capital Markets. Your line is open.

Kemp Dolliver, Analyst

Great. Thank you. Couple of questions regarding the ASCEND trial. First is you amended the protocol in the last few months, and I want to get more details regarding the changes and the rationale for the changes.

David Mazzo, Chief Executive Officer

Certainly, Kemp. Thanks for dropping on the call and for the question. So we actually will be releasing some information in the next couple of weeks. We will give a much broader discussion of the evolution of ASCEND, but I can give a top line summary right now. When ASCEND was started, it had sort of a single purpose was to replicate the Phase Ib/IIa data but in a placebo-controlled trial. The AGITG did something that typically a commercial drug developer wouldn't do, but they actually decided that they wanted to power the trial to determine some efficacy endpoints as well. So that was the trial that we inherited. When we looked at that trial, we saw that that was great, but there were at least one other thing that we thought should have been done, and that's the basic tenet of the amendment and that we added a second cohort of patients, very creatively called cohort B. That second cohort actually will receive two doses of LSTA1 separated by about four hours. So they still receive gemcitabine, nab-paclitaxel and LSTA1 essentially co-administered at the start. But four hours later, they'll get a second dose of LSTA1. The reason for that is, if you look at the pharmacokinetic profile, the Cmax, the Tmax and half-life of these different compounds, you realize that gemcitabine has a half-life of roughly 2 hours or 90 minutes or something that way. LSTA1 has a half-life of about the same, but nab-paclitaxel has a half-life of about 10 to 12 hours. There was at least some thought process that said if you waited two or more half-lives after the first dose of LSTA1, essentially, you're outside the therapeutic range of LSTA1, gemcitabine is all gone, but you're still within the therapeutic range of nab-paclitaxel. A second dose of LSTA1 might provoke improved penetration of the remaining nab-paclitaxel into the tumor and might have a positive effect on tumor efficacy. So in some ways, this is part of what would be a typical Phase IIb trial in that we're doing a little bit of dose ranging, if you will, as part of the trial as well. But we have now also these two cohorts, and so we can compare each cohort against placebo and then the two cohorts against each other and then perhaps the combination of the two cohorts if there's no difference against placebo as well and get a really strong indication of therapeutic effect size as well as safety profile for what would be likely the Phase III trial that would follow.

Kemp Dolliver, Analyst

Great. That's helpful. So you mentioned powering and a registrational trial, but is it fair to say that that's possible but has a low probability?

David Mazzo, Chief Executive Officer

Yes, our expectation is not that this will be a registration trial but that it will provide solid support for designing a future registration trial. That said, we will explore all options with the FDA and especially the TGA in Australia, where most of the trial sites are located, to determine if, based on positive and statistically significant data, they would be open to an accelerated or conditional path to approval.

Kemp Dolliver, Analyst

Super. Thank you.

Operator, Operator

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

Pete Enderlin, Analyst

Thank you. Hi, everybody. Conceptually, I thought that, originally, the idea was that LSTA1 could either be co-administered, which is what you're just talking about, or tethered. And you just said, Dave that that's not really what you're anticipating now. So is it true that you're really not contemplating...

David Mazzo, Chief Executive Officer

No, let me clarify. The two approaches, either co-administration or tethering, remain distinct possibilities. In the past, I’ve described the co-administration approach as the fastest route to a first registration for the reasons I mentioned earlier. With tethering, you create a new chemical entity that needs to be fully characterized both biologically and chemically. This means you're essentially starting from scratch with that kind of product. With co-administration, you're leveraging the existing knowledge base of the established standard of care and simply adding to it. Therefore, it is a simpler, faster, and likely less expensive way to achieve results and obtain a registration. That is our primary focus at this time. However, it doesn't imply that tethering is off the table; it just takes a lower priority internally.

Pete Enderlin, Analyst

Thanks for clarifying that. And then sort of looking several years ahead, but that's what we try to do, when you're talking about combination therapies, which is what these all are, and the agreements that you have or the ones that you contemplate and try to enter into, do you tie the sales and pricing together? Or is each company sort of on its own and they're separate and independent for each entity that you bring to the party in a particular application or indication? For example, I mean, you can have gemcitabine or paclitaxel and LSTA1, and you could either have a package sale or sell them and price them independently. So which way do you typically anticipate going?

David Mazzo, Chief Executive Officer

Right now, we expect this to be an add-on to existing therapy. Those therapies could already be generic or might become generic by the time we reach the market. However, our product will remain under patent and will be priced accordingly as an add-on, complementing the effectiveness of those less expensive and well-established standards of care. Based on our current thoughts, it seems unlikely that we would bundle these products together and price them as a package since we do not own the other products and wouldn't be able to manufacture them. While we could source and bundle them, there isn't a strong incentive to do so. Our goal is to create a wide range of nonexclusive opportunities that show how, when combined with certain products, those products perform better, which would boost their sales. It only benefits us if they are used alongside our product, allowing us to benefit individually. As we progress, it’s not entirely out of the question that someone might seek to create an exclusive benefit within a class of compounds, in which case we would appropriately price an exclusivity deal.

Pete Enderlin, Analyst

But in the initial agreements you have with these other players, you don't really spell out exactly what any such combination entails.

David Mazzo, Chief Executive Officer

The current agreements are essentially development agreements. They just say that we will work together to demonstrate, hopefully, that the addition of LSTA1 improves the products that are already considered standard of care. If that works, as I said, that will be enough to improve everyone’s bottom line in the long run. But at that point, it's possible that those companies may want to enter into exclusive deals to prevent us from being combined with other compounds of the same class in those indications. And in order to get exclusivity like that, the deals would have to be much richer as it relates to us.

Pete Enderlin, Analyst

Right. Okay, great. Thanks a lot.

Operator, Operator

Thank you. Our next question comes from Joe Pantginis with H.C. Wainwright. Your line is open.

Joe Pantginis, Analyst

Hey, everybody, good afternoon. And thanks for taking the question. Two questions, if you don't mind, Dave. So first, it's nice to see you guys continuing with your track record on cash management especially in the continuing environment. So with that said, I guess my two questions really are, obviously, you're expanding your clinical trial, so that will be the lead driver for expenses increasing. But where do you currently stand on your current manufacturing needs for LSTA1 as well as your interim to more long-term needs?

David Mazzo, Chief Executive Officer

Thanks, Joe. I appreciate the question and thanks for participating. As I think both James and Kristen have said during their prepared remarks, with the changes that we've made, we now can assure that we will fund all of our programs. As I've mentioned, I think, in the past, some of these programs are co-funded, and many of them are being operated in areas where we'll get R&D rebates, which contributes to a reduction in costs. Some of them are completely funded by the other partner, but yet we retain rights to our product. With that said, we now can project with a fair degree of confidence that we will be, with our existing capital, able to fund all of our programs, both ongoing and proposed, as outlined in the corporate presentation, through to availability of data. That’s into the early part of 2026. All of the things that we talked about starting are already included in that as are all of the drug and manufacturing needs, including clinical supplies as well as the appropriate validations and stability, manufacturing and lots to keep the CMC portion of development essentially in line with the clinical portion.

Joe Pantginis, Analyst

That's great to hear. I'm curious, among all the programs you discussed today, which of these has the rate-limiting step concerning patient enrollment and competition with other studies?

David Mazzo, Chief Executive Officer

There are a fair number of pancreatic cancer studies ongoing, and there are studies in all these other solid tumors. So we do have competition, but I think there is quite a bit of enthusiasm about our trial. Rather than fumbling through this answer, I'll put Kristen on the spot and see if she can give some sense about what we think will be the toughest to enroll and how we've constructed our enrollment projections.

Kristen Buck, Chief Medical Officer

Thank you for the question. We are actively involved in pancreatic cancer research, but we have been careful to ensure our studies do not compete with each other. As you may be aware, there are two main standards of care for pancreatic cancer: FOLFIRINOX and gem/nab-paclitaxel. We have designed separate trials for patients eligible for each of these treatments. In one of our trials, we are focusing on nonresectable locally advanced cases, aiming to convert these tumors into resectable ones, which involves a different patient population. Regarding the ASCEND trial, there is no competition since it is taking place in Australia. In response to the second question about recruitment challenges, I would say that one segment of the BOLSTER Trial, specifically for esophageal carcinoma of the squamous cell type, may face recruitment difficulties. This type is less common in the U.S. and challenging to treat, so we might need to look for participants in Asia and other parts of Europe. Overall, we have been very strategic in selecting our patient populations to avoid any internal competition among our trials.

Joe Pantginis, Analyst

Got it. Appreciate all the color.

Operator, Operator

Our next question is a follow-up from Pete Enderlin with MAZ Partners. Your line is open.

Pete Enderlin, Analyst

Yes, just a quick one. What do you have in the way of remaining New Jersey tax NOLs? And what would be the timing of their availability and contemplated use of those?

David Mazzo, Chief Executive Officer

Okay. Well, the contemplated use is easy. We applied that to what generally is characterized as general expenses.

Pete Enderlin, Analyst

No, no, I mean, how soon you take advantage of them? I know you use it for whatever. But...

David Mazzo, Chief Executive Officer

We have about $2 million to $3 million left under the current program, which limits each company to a $20 million lifetime benefit. This amount could be adjusted, as it has been before, changing from $15 million to $20 million two years ago. The state might increase it again. However, under the existing cap, we have a couple of years left for availability. We anticipate collecting roughly half of the remaining amount next year and the rest the following year, likely reaching the cap. Therefore, we estimate that between $1 million to $1.5 million a year will be available over the next two years based on current eligibility.

Pete Enderlin, Analyst

Okay. Well, every bit helps.

David Mazzo, Chief Executive Officer

Yes.

Operator, Operator

Thank you. This concludes the question-and-answer session. I would now like to turn the call back over to Dr. Mazzo for closing remarks.

David Mazzo, Chief Executive Officer

Thanks, operator. And again, thank you all for participating in today's call. And I really appreciate the questions that gave us the opportunity to provide some additional color. We look forward to speaking with you again during our next quarterly conference call and continuing to provide updates on our achievements and progress. We remain grateful for your continued interest and support in Lisata. And we wish you a very good evening. Thank you, and goodbye.

Operator, Operator

Thank you for your participation. This does conclude the program. You may now disconnect. Everyone have a great day.