Lisata Therapeutics Q1 2023 Earnings Call Transcript

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May 9, 2023

There are 9 speakers on the call.

Operator

Welcome to the Lacyta Therapeutics First Quarter 2023 Financial Results and Business Update Conference Call. Currently, all participants are in a listen only mode. Following management's prepared remarks, we will hold a Q and A session. You would then hear an automated message advising that your hand is raised. As a reminder, this call is being recorded today, Tuesday, May 9, 2023.

Operator

I will now turn the call over to John Menditto, Vice President of Investor Relations and Corporate Communications at Lazada. Please go ahead, sir.

Speaker 1

Thank you, operator, and good afternoon, everyone. Welcome to Lazada's Q1 2023 conference call to discuss our financial results and Joining me today from our management team are Doctor. David Mazzo, Chief Executive Officer Doctor. Kristin Buck, Executive Vice President of Research and Development and Chief Medical Officer and James Misko, Vice President of Finance and Treasury. Shortly before this call, we issued a press release announcing our Q1 2023 financial results, which is available under the Investors And news section of the company website, along with the webcast replay of this call.

Speaker 1

If you have not received this news release or if you would like to be added 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 Lazada. I encourage you to review the company's filings with the Securities and Exchange Commission, including, without limitation, its Forms 10Q, 8 ks and 10 ks, 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. Lazada undertakes no obligation to revise or update any statements to reflect With that, I will now turn the call over to Doctor. Mazzo.

Speaker 1

Dave? Dave, I believe you may be on mute.

Speaker 2

There we are. We're having technical difficulties today. My apologies, everyone. 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 Q1 2023 financial results and give an update on progress of our various development programs.

Speaker 2

During the Q1, the vast majority of our efforts remained focused on advancement of our clinical development programs for the treatment of advanced solid tumors. As those who follow us now know, VASADA is a clinical stage therapeutics 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 the pharmacoeconomically attractive paradigm. Lista-one, Our lead product candidate is the subject of multiple plans and ongoing clinical trials being conducted globally in a variety of solid tumor types and in combination with multiple anti cancer agents of differing modalities. Based on substantial preclinical And most importantly, early human clinical data, we believe that Lista-one has the potential to become an integral part of a revised standard of care treatment regimen for many difficult to treat cancers.

Speaker 2

Our Chief Medical Officer, Doctor. Kristin 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.

Speaker 2

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 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 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 LASATA And I will take this opportunity to publicly acknowledge his many contributions to the evolution of CEM Therapeutics and the transaction that formed LASATA. David was instrumental in leading the efforts to identify a means by which to exploit the promise of Lista-one in the comprehensive clinical development program As he was in the licensing deal of ListaOne with our Chinese partner, Qiwu Pharmaceutical. We are grateful for his past contributions and wish him well in the future.

Speaker 2

And with that, I now will turn the call over to James Nisko, our VP of Finance and Treasury to review and provide commentary on our financial results. James?

Speaker 3

Thanks, Dave. Good afternoon, all. I'm pleased to join you today to present a summary of our Q1 2023 financial results. Starting with operating expenses. Research and development expenses were approximately $3,200,000 For the 3 months ended March 31, 2023, compared to $3,300,000 for the 3 months ended March 31, 2022, representing a decrease of $100,000 or 3.2%.

Speaker 3

This was primarily due to expenses associated with our Exona Phase 2b study, the FREEDOM trial in the prior year, Partially offset by study start up activities in the current year associated with the planned Phase 2 Proof of concept bolster trial studying Lista-one in various solid tumors in combination with the corresponding standards of care. Enrollment activities for the Lista 1 Phase 2b Ascent study And chemistry and manufacturing and control activities for Lista 1. General and administrative expenses Approximately $3,700,000 for the 3 months ended March 31, 2023 compared to $3,300,000 for the 3 months ended March 31, 2022, representing an increase of $300,000 or 9.8 percent. This was primarily due to the addition of 1 employee acquired through the merger with Cen Therapeutics, an increase in external legal fees and an increase in accounting and tax related fees. Overall, Net losses were $6,200,000 for the 3 months ended March 31, 2023 compared to $4,200,000 for the 3 months ended March 31, 2022.

Speaker 3

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 $61,100,000 These figures do not include the recently announced $2,200,000 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 Q2 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 Q1 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, Doctor.

Speaker 3

Kristin Buck, for the review of our clinical development pipeline. Kristin?

Speaker 4

Thank you, James, and good afternoon, everyone. I realize that we just reviewed our programs a few weeks ago during our full year 2022 Results call, but I believe it's important to keep our stakeholders up to date on the continuous progress being made by the LASATA team. LASASA'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 technologies are designed to address major impediments to successful treatments of solid tumors in the context of increasing pharmacoeconomic pressures on the healthcare system. We appreciate the critical importance of generating meaningful clinical data to advance our platform technology And I can assure you that our entire organization has this goal top of mind in everything we do.

Speaker 4

With that, I will now provide a summary and status update for each of LASATA's active clinical development programs, Kicking off with our lead product candidate LSTA or Lista-one 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 treat effectively. Cancers such as pancreatic cancer, gastric cancer and other solid tumors are surrounded by dense fibrotic tissue known as stroma, which limits access of most pharmacotherapies to the tumor. Many tumors also exhibit a hostile tumor microenvironment or TME, which suppresses a patient's immune system and makes it less effective in fighting cancer. The combination of a dense stroma and a hostile TME Negatively impacts the ability of many cytotoxic agents and immunotherapies to effectively treat these cancers.

Speaker 4

This coupled with the fact that most anticancer therapies are not efficient in targeting only cancer tissue Defines the major challenge in maximizing effectiveness and safety in the treatment of solid tumors. To combat this, LASATA's approach is to activate the C end rule or Send R system, A naturally occurring active transport system to selectively deliver anticancer drugs through the stroma and into the tumor. LASATA's lead product candidate, LISTA-one is an investigational drug that actuates the CEND R active transport mechanism, while also having the potential to modify the tumor microenvironment and make it less immunosuppressive. Lista-one 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 up regulated on these cells, but not necessarily healthy tissue. Lista-one is a 9 amino acid cyclic internalizing RGD peptide that Once bound to these integrins is cleaved by proteases expressed in the tumor microenvironment to release a peptide fragment called The Sendar fragment then has high affinity for and binds to an adjacent receptor called neuropilin 1, Also up regulated on tumor vascular endothelial and tumor cells to activate the CN Rule active transport pathway and ferry anti cancer drugs more efficiently into solid tumors.

Speaker 4

Additionally, Lista-one has been shown in a range of to the efficacy of anticancer drugs used against solid tumors. These results come internally from LASATA and from collaborators and research groups around the world and have been the subject of over 200 scientific publications. Along with our collaborators, we have amassed significant non clinical data demonstrating enhanced delivery of a range of emerging anticancer therapies, including immunotherapies and RNA based therapeutics. Clinically, Lista-one has demonstrated favorable safety, tolerability and activity To enhance delivery of standard of care chemotherapy for patients with metastatic pancreatic cancer, Our development programs are designed to exploit the potential of Lista-one to enhance a variety of anticancer treatment modalities in a range of solid tumors. Currently, List of 1 is the subject of about a dozen planned or active clinical trials globally for the treatment of various solid tumors.

Speaker 4

Let me touch on a few of these individually. Firstly, the ASCEND trial is a 155 patient, double blind, randomized, placebo controlled Clinical trial evaluating Lista-one in combination with gemcitabine and nab paclitaxel in patients with metastatic The trial is being conducted at up to 40 sites in Australia and New Zealand, led by the Australasian Gastrointestinal Cancer Trials Group or AGITG. In collaboration with the NHMRC Clinical Trial Centre at the University of Sydney, we are very pleased with the work of AGITG. To date, an enrollment is progressing quite well. We originally projected enrollment completion by the Q2 of 2024, But if current enrollment rates continue, we could complete enrollment sooner than that.

Speaker 4

Just recently, along with our clinical research partner WARP-nine, we treated 2 In locally advanced nonresectable pancreatic ductal adenocarcinoma. This is the first of several planned trials in which we are expanding the study of Lista-1's impact on existing therapies to include immunotherapies. We also expect enrollment completion in this trial by the Q2 of 2024. Next is Sendafox. Sendafox, the Phase 1b2a open label trial of Lista-one in combination With neoadjuvantfulfironox based therapies in pancreatic, colon and appendiceal cancers Continues to make steady progress and we expect enrollment completion by the Q4 of this year with data readouts in 2024.

Speaker 4

This trial will provide us with post treatment biopsy immuno profiling data as well as long term outcome data. Lista-one is also currently being evaluated In combination with gemcitabine and nab paclitaxel and a Phase 1b2a open label trial in China, led by our licensee in that territory, Qilu Pharmaceutical. Preliminary progression free survival data are expected to be presented at the upcoming ASCO meeting in June. The company's bolster trial of LISTEN-one is a Phase 2 placebo controlled basket trial Evaluating Lista-one in combination with standards of care in advanced solid tumors, including head and neck, Esophageal and cholangiocarcinoma. This trial will include both cytotoxic and immunotherapy standards of care.

Speaker 4

We're excited to announce this trial is now up and running and we hope to announce enrollment of the first patient by the end of the second quarter. Lastly, I, Golista, a Phase 1b2a proof of concept safety and early efficacy study Evaluating Lista-one in combination with nivolumab and fulferonox as a first line treatment in locally advanced Nonresectable gastroesophageal adenocarcinoma is on track to initiate by the Q3 of this year. In addition to the clinical trials I just mentioned, we also plan to have other studies up and running in the next few months, including Lista-one in combination with temozolomide in glioblastoma multiform or GBM, as well as List 1 in combination with HIPEC intraoperative intraperitoneal lavage in patients with peritoneal carcinomatosis. For those who are interested, a more complete description of each of our trials is available in the appendix of the corporate presentation available on our website. Additionally, in the body of the presentation, there are two slides that depict the anticipated timing of all data readouts from our trials.

Speaker 4

Turning now to LISTEN-twelve, also known as HENEDRA in Japan, Our product candidate for the treatment of critical limb ischemia or CLI and Buerger's disease. Onegira is the company's sakagaki designated product candidate for the treatment of CLI in Buerger's disease in Japan. As we have reported for several quarters, we have completed a registration eligible study of HENEDRA in Japan and those data from that study form the basis of a pre consultation and ultimately a consultation process with the Japanese regulatory authorities to determine the next step of development for the program. To date, the PMDA has provided advice on how to proceed excuse me, to how to prepare For the formal consultation meeting and has indicated their preference for additional clinical information to accompany the filing of a JNDA. As a result, we are considering our options for next steps and have engaged a specialized boutique firm To assist in our efforts to secure a Japanese partner to complete the remaining steps of development and registration, as well as eventual commercialization in Japan.

Speaker 4

Lastly, LSTA-two zero one for the In 2022, the company initiated a Phase 1b Open label proof of concept trial evaluating LISTEN-two zero one, a CD34 positive regenerative cell therapy investigational product for intrarenal artery administration in patients with diabetic kidney disease. Our proof of concept protocol had the objective of determining the tolerance of intrarenal cell therapy injection In DKD patients as well as the ability of LISTEN-two zero one to regenerate kidney function. As we reported on 6 February 2023, the top line results from the study showed that LISTEN-two zero one was safe and well tolerated by patients with no serious adverse events related to the therapy. However, the study did not demonstrate A consistent improvement in kidney function among all patients. That said, encouragement received from the study's principal investigator and key opinion leaders Let us conclude that there still may be potential for use of CD34 positive cell therapy for the treatment of diabetic kidney disease.

Speaker 4

Further development of LISTEN-two zero one though will certainly require significantly larger studies in capital investment and thus development by LASATA Would only be continued if a strategic partner that can contribute the necessary capital for future development is identified. With that, I will now turn the call back to Dave.

Speaker 2

Thanks, Kristen. As Kristen has outlined, the LASATA 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

Thank you. Each listener will be permitted to ask one question at a time and we'll return to the queue for any additional questions. Our first question Comes from Steve Brozak with WBB Securities. Your line is open.

Speaker 5

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 So you're working with on what they're seeing, the importance and how this basically works into What they've done in the past.

Speaker 5

And I'll hop back into queue after that. Thank you.

Speaker 2

Thanks, Steve. Nice to talk to you and appreciate your question. 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 a biggest difference and whether or not they felt that the approach that we were espousing Actually, was sensible to them. And 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, then brand new NCEs that have to start Developing an efficacy profile from scratch.

Speaker 2

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 that's 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 Lista 1 is doing exactly what we purported to do.

Speaker 5

Can I tack on one addendum? On the regulatory side, given the fact that you 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.

Speaker 2

Well, I think the advantage from a regulatory perspective is to some extent obvious. When you're just Adding something into an already existing regimen and we and by adding, I mean, we simply co administer these products. So there's no the only mixing, if you will, that takes place is inside the body. That makes formulation And stability and all of those chemistry and manufacturing control issues simpler to deal with. These are not new chemical Entities in the sense that we're not tethering the anticancer agents with Lista-one.

Speaker 2

So lots of preclinical work doesn't need to be done. Separate toxicology doesn't need to be done of these new entities. And the fact that List 1 in and of itself seems to be so benign from a safety perspective Makes this very easy to go to predict. And so we've had very positive interactions with the FDA, the TGA in Australia, We've just started our interactions with the EMA in Europe. And so far, we haven't seen any particular hurdles and the discussions are proceeding As we expected.

Speaker 5

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

Operator

Thank you. Our next question comes from Kempe D'Aliver with Brookline Capital Markets. Your line is open.

Speaker 6

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

Speaker 2

Certainly, Tim. 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 has sort of a single purpose was to replicate the Phase IbIIa data, but in a Placebo controlled trial and 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.

Speaker 2

So that was the trial that we inherited. When we looked at that trial, we thought 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 D. And that second cohort actually will Received 2 doses of Lista-one separated by about 4 hours. So, they still receive gemcitabine, nap paclitaxel and LIST-one essentially co administered at the start, but 4 hours later, they'll get a second dose of LIST-one. And the reason for that is, If you look at the pharmacokinetic profiles, the Cmax, the Tmax, the half life of these different compounds, you realize that gemcitabine Has a half life of roughly 2 hours or 90 minutes or something like that.

Speaker 2

LIFTA-one has a half life of about the same, But now paclitaxel has a half life of about 10 to 12 hours. And so there was at least some thought process that said, if you waited 2 or more half lives after the first dose of LIST-two 1, essentially You're outside the therapeutic range of LIST-one gemcitabine is all gone, but you're still within the therapeutic range of now placotaxel and a second dose of LIST-one might Provoke improved penetration of the remaining map 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 2b trial And 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 2 cohorts and so we can compare Each cohort against placebo and then the 2 cohorts against each other and then perhaps the combination of the 2 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 the what would be likely the Phase 3 trial that would follow.

Speaker 6

Great. That's helpful. So you mentioned powering and I think registrational trial, but that would seem to be So it's fair to say that that's possible, but low probability?

Speaker 2

Yes. That's our our expectation It's not that this will be a registration trial, but that it will be a solid support for designing a registration trial that will go forward. Now That said, we will pursue every avenue with FDA and especially the TGA in Australia, where the majority of the sites are for this trial to see if the data are positive and statistically significant, if they would consider an accelerated path or a conditional path to approval.

Speaker 6

Super. Thank you.

Speaker 2

Thanks, Kim.

Operator

Thank you. Our next Question comes from Pete Enderlin with MAZ Partners. Your line is open.

Speaker 7

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

Speaker 2

Let me clarify. Okay. Okay. So The two approaches, either co administration or tethering remain distinct possibilities.

Speaker 7

Okay.

Speaker 2

I think in the past, I've described the co administration approach as the rapid most rapid approach to a first registration, for the reasons that I outlined briefly a moment ago. With tethering, you create a new chemical entity That needs to be fully characterized and both biologically and chemically. And those are much you're basically starting from 0 with that kind of Product. With coadministration, you're basically starting using the knowledge base of the established standard of care And just adding on to it. So it's a simpler, faster, most likely less expensive way to getting to answers and to a registration.

Speaker 2

And that's what we're pursuing first, but it doesn't mean that tethering is off the table. It just means it's second in line from a priority perspective internally.

Speaker 7

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 are the ones that you contemplate and try to enter into. Do you tie the sales and the pricing together or is each Company is 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 gemcitamine or paclitaxel and list of 1 And you could either have a package sale or sell them and price them independently. So which way do you typically Anticipate going.

Speaker 2

So we would right now, the anticipation is that this will be an add on to And those as I said, those therapies could already be generic or could become generic by the time we get to market. But our product will not be generic. It will still be under patent and it will be priced accordingly as an add on, which augments Efficacy of those less expensive and more tried and trued well characterized standards of care. So I think that it would be unlikely based upon our current thinking that we would bundle these, meaning actually Package them together and price them as a bundle because we wouldn't own the other products. We wouldn't Be in position to manufacture them.

Speaker 2

We could source them and bundle them, but there's no real benefit necessarily to doing that. And what we're doing is looking to Create a large list of non exclusive opportunities that essentially demonstrates that in combination with certain products, Those products get better and so their sales will benefit and it only works if they add on with us And so we will benefit separately. Now as we get further along, it's not completely out of the question that someone would want to make this an exclusive benefit In a class of compounds, and so we would price a deal for exclusivity appropriately in that case.

Speaker 7

So, but in the initial agreements that you have with these other players, you don't really Spell out exactly what any such combination?

Speaker 2

The current agreements Essentially development agreements, they just say that we will work together to demonstrate hopefully that the addition of ListaOne Improves the products that are already considered standard of care. And 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.

Speaker 7

Right. Okay, great. Thanks a lot.

Speaker 2

Sure. Thanks, Pete.

Operator

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

Speaker 8

Hey, everybody. Good afternoon. 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 cash management, especially in the continuing environment.

Speaker 8

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 Alisto 1 as well as your interim to more long term needs.

Speaker 2

Thanks, Joe. I appreciate the question and thanks for participating. So, as I think both James and Kristen have said during their With the changes that we've made, we now can assure that we will fund all of our programs. And 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 and D rebates, which contributes to a reduction in cost and 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.

Speaker 2

And so that's into the early part of 2026. And 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.

Speaker 8

That's great to hear. And then curious with all the programs that you have discussed today, which one of these indications have the or I'd say like the rate limiting step with regard to patient enrollment, with regard to competing for patients with other studies.

Speaker 2

Well, 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's quite a bit of enthusiasm about our trial. And rather than fumbling through this answer, I'm going to 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.

Speaker 4

Yes. Thanks for the question. I'll start off by saying we do have a lot in pancreatic But we've been very careful to not have them cannibalize each other such that some, as you well know, probably Pancreatic cancer has 2 main standards of care for filpironox and gemnab paclitaxel. So we've tried to exploit both of those standards of care, such that those who are eligible for procuronox will have a separate trial and those who are eligible for gemnav are in a separate trial. And then in one of our pancreatic trials, we are doing nonresectable locally advanced such that we could change a tumor that is nonresectable and make it So that's a different patient population.

Speaker 4

For the ASCEND trial, there really isn't competition because it isn't occurring in Australia. So if I were to answer the second question, which is the hardest to recruit, I would say one of the arms of the bolster trial may be difficult to recruit, which is esophageal carcinoma squamous cell type. It's not the most common in the U. S, but it is the most challenging to treat. So we may have to go to Asia and other parts of Europe to recruit this trial.

Speaker 4

But for the most part, we've been very diligent and strategic in choosing our patient population such that we wouldn't internally cannibalize each of our trials.

Speaker 8

Got it. Appreciate all the color.

Speaker 4

You're welcome.

Operator

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

Speaker 7

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?

Speaker 2

So, the

Speaker 7

contemplated use of those.

Speaker 2

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

Speaker 7

mean, when you How soon you take advantage of them? I know you use it for whatever, but

Speaker 2

All right. So, we have approximately $2,000,000 to $3,000,000 left under the current program, which caps every company at $20,000,000 lifetime Benefit, that could change. It's already changed once 2 years ago from 15 to 20, the state could raise it again. But under the current cap, We have a couple of years of availability left in terms of and we probably collect roughly half Next year and half of what's remaining the following year and that would probably take us to the cap. So That's roughly it's somewhere between $1,000,000 to $1,500,000 a year over the next 2 years is what remains in terms of current eligibility.

Speaker 7

Okay. Well, every bit helps. Thanks a lot.

Speaker 2

Okay. Thank you.

Operator

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

Speaker 2

Thanks, operator. And again, thank you all for participating to today's call. And I really appreciated the 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 LASATA And we wish you a very good evening. Thank you and goodbye.

Operator

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

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