Lisata Therapeutics Inc. Q1 2023 Earnings Call
Welcome to the father Therapeutics first quarter 2023 financial results and business update conference call. Currently all participants are in listen only mode.
Following managements prepared remarks, we will hold a Q&A session to ask a question at that time. Please press star one one on your telephone you would then here an automated message advising that your hand as rates as.
As a reminder, this call's being recorded today Tuesday may nine 2023.
Now I'll turn the call over to John Mindy Lowe, Vice President of Investor Relations and corporate Communications at Lisa. Please go ahead Sir.
Thank you operator, and good afternoon, everyone welcome to as others.
<unk> 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. Christian <unk> Executive Vice President of research and development and Chief Medical Officer, and James <unk>, Vice President of Treasury 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 and 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 email distribution list. Please email me at J D.
It lays out a dot com.
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 this autumn.
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 May 19 2023.
<unk> 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.
Dave I believe you may be on mute.
Yeah, 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.
First our first quarter 2023 financial results and give an update on progress of our various development programs.
During the first quarter the vast majority of our efforts remain focused on advancement of our clinical development programs for the treatment of advanced solid tumors as those who follow US know notes Masada is a clinical stage therapeutics development company with a novel solid tumor targeting and penetration technology to improve the efficacy of anti cancer drug.
Our development.
<unk> portfolio contains programs that are designed to bring significant therapeutic improvement in the treatment of solid tumors and a pharmacodynamic Lee attractive paradigm.
Mr. Juan.
Our lead product candidate is the subject of multiple planned and ongoing clinical trials being conducted globally and a variety of solid tumor types and in combination with multiple anti cancer agents of different modalities based on substantial preclinical and most importantly early human clinical data, we believe that list of one.
Has the potential to become an integral part of our revised standard of care treatment regimen for many difficult to treat cancers, our chief Medical officer, Dr. Christian back shortly will provide more specifics on our clinical programs. Following a 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 up to date and that may exist for the foreseeable future.
With that in mind, and coupled with our operational imperatives to ensure that we have sufficient capital to reach important data milestones for all of 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 measures that were enacted with the streamlining of our organization at the nonexecutive and executive level.
As part of this organization optimization, the president the position of President and Chief Business Officer was eliminated and David Slacks employment with the company was ended.
On a personal level, we are saddened to see Davids departure from Masada and I will take this opportunity to publicly acknowledge his many contributions to the evolution of <unk> therapeutics and the transaction that formed Lossada.
David was instrumental in leading the efforts to identify a means by which to exploit the promise of Lister, one and a comprehensive clinical development program as he was in a licensing deal of list of one with our Chinese partner <unk> pharmaceutical we are grateful for his contributions and wish him well in the future and with that.
I now will turn the call over to James NIPSCO, Our VP of finance and Treasury to review and provide commentary on our financial results James.
Thanks, Dave Good afternoon, all I am 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 three 2%.
This was primarily due to expenses associated with our <unk> phase <unk> study, the freedom trial and the prior year.
Partially offset by study startup activities in the current year associated with the planned phase two proof of concept bolster trial studying lister one in various solid tumors in combination with the corresponding standards of care.
Enrollment activities for the lift the one phase <unk> study and chemistry and manufacturing a control activities for a list of one.
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 Rep.
Representing an increase of 0.3 million or nine 8%.
This was primarily due to the addition of one employee acquired through the merger with <unk> Therapeutics and.
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 and 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 cost 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 'twenty 'twenty six and <unk>.
<unk> 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. Chris Christopher Buck.
For the review of our clinical development pipeline Kristen.
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 results call, but I believe it's important to keep our stakeholders up to date on the continuous progress being made by the soccer team.
<unk> 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 treatment of solid tumors in the context of increasing pharmacokinetic 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 a summary and status update for each of <unk> active clinical development programs.
Kicking off with our lead product candidate L. S. T. A R list of one for the treatment of advanced solid tumors in combination with other anti cancer 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 not as stroma, which limits access of most pharmacotherapy to the stoop to the tumor.
Many tumors also exhibit a hostile tumor microenvironment or T M E, which suppresses a patient's immune system and makes it less effective in fighting cancer.
The combination of a dense stroma.
And are hostile TMA negatively impacts the ability of many cytotoxic agents and immunotherapies to effectively treat these cancers.
This coupled with the fact that most anti cancer therapies are not efficient and targeting only cancer tissue.
Defines the major challenge in maximizing effectiveness and safety in the treatment of solid tumors.
To combat this <unk> approach is to activate the C and rule or send our system and.
And naturally occurring active transport system to selectively deliver anti cancer drugs.
Through the stroma and into the tumor.
<unk> lead product candidate list of one is an investigational drug that actuate the send our active transport mechanism, while also having the potential to modify the tumor microenvironment and make it less immunosuppressive.
Lister, one targets tumor vascular endothelial cells as well as tumor cells themselves.
Based on its affinity for alpha.
Beta three in beta five integrant that are up regulator on the cells, but not necessarily healthy tissue.
Lister one is a nine amino acid cyclic internalizing RGD B R. G D peptide that once bounded these immigrants.
Is cleaved by Proteus is expressed in the tumor microenvironment to release, a peptide fragment called the send our fragment.
This end our fragment than has high affinity for and binds to an adjacent receptor called neuro Pelon. One also up regulated on tumor vascular endothelial tumor cells.
To activate the CN rule active transport pathway.
And ferry anti cancer drugs more efficiently into solid tumors.
Additionally list of 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 anti cancer drugs used against solid tumors.
These results come internally from Lossada.
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.
Our range of emerging anti cancer therapies, including Immunotherapies and.
<unk> RNA based therapeutics.
Clinically Lister 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 list of one two.
To enhance a variety of anti cancer treatment modalities in a range of solid tumors.
Currently list of one is the subject of about a dozen planned or active clinical trials globally for the treatment of various solid tumors.
Let me touch on a few of these individually.
Yeah.
Firstly, the ascend trial is a 155 patient double blind randomized placebo controlled clinical trial evaluating list of one 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 Australia Asian, gastrointestinal cancer trials group or a G ITG.
In collaboration with the NH MRC clinical trial center at the University of Sydney.
We are very pleased with the work of Agi T G.
To date and enrollment is progressing quite well.
We originally projected enrollment completion by the second quarter of 2024.
But if current enrollment rates continue.
We can complete enrollment sooner than that.
Just recently along with our clinical research partner Warp nine we treated two of our first patients in the I listed trial in Australia evaluating Lister one in combination with standard of care Gemcitabine and Nab Paclitaxel chemotherapy.
<unk> immunotherapy that use <unk> 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 list of one's impact on existing therapies to include Immunotherapies.
We also expect enrollment completion in this trial by the second quarter of 2024.
Next is send to Fox.
Send to Fox the phase one B two eight open label trial of list. The one in combination with new adjuvant full <unk> based therapies in pancreatic colon and Appendiceal cancers.
Continues to make steady progress and.
And we expect enrollment completion by the fourth quarter of this year with data Readouts in 2024.
This trial will provide us with post treatment biopsy immuno profiling data.
As well as long term outcome data.
Lister one is also currently being evaluated in combination with Gemcitabine and Nab Paclitaxel in a phase one b two way open label trial in China.
Led by our licensee in that territory Qi Lu pharmaceutical.
Preliminary progression free survival data are expected to be presented at the upcoming Astro meeting in June .
The Companys bolster trial of list of one is a phase two placebo controlled basket trial evaluating Lister one in combination with standards of care in advanced solid tumors, Inc.
Including head and neck.
Esophageal and KOL NGL carcinoma.
This trial will include both cytotoxic and immunotherapy standards of care.
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 go Lister a phase one b to a proof of concept safety and early efficacy study evaluating Lister one in combination with knee volume App and fulfill <unk> as a first line treatment in locally advanced non Resectable gastroesophageal.
Adenocarcinoma is on track to initiate by the third quarter 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 list of one in combination with team of dolomite.
In Glioblastoma multi form or GBM.
As well as list of one in combination with high pack inter operative inter peritoneal lavage in patients with partner 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.
Turning now to listed 12 also known as <unk> in Japan, our product candidate for the treatment of critical limb ischemia or CLI and burgers disease.
<unk> is the company's soccer cocky designated product candidate for the treatment of CLI and burgers disease in Japan.
As we have reported for several quarters, we have completed a registration eligible study of <unk> 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 P. M. D. A has provided advice on how to proceed excuse me two helped to prepare for.
The formal consultation meeting and has indicated their preference for additional clinical information to accompany the filing of the J NDA.
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.
Lastly.
S T. A 201 for the treatment of diabetic kidney disease or decay D.
In 2022, the company initiated a phase <unk> open label proof of concept trial evaluating listed 201.
CD 34 positive regenerative cell therapy investigational product for intra renal artery administration.
In patients with diabetic kidney disease.
Our proof of concept protocol had the objective of determining the tolerance of intra renal cell therapy injection in decay D patients as well as the ability of list of tier one to regenerate kidney function.
As we as we reported on six February 2023, the topline results from this study showed that listed 301 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 led us to conclude that there still may be potential for use of CD 34 positive cell therapy for the treatment of diabetic kidney disease.
Further development of listed two of one, though we will certainly require significantly larger studies in capital investment and thus development by Lossada 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.
Thanks Kristen.
As Christian has outlined the Lossada 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 to physicians, who treat them and our shareholders and with that operator, we're now ready to take questions.
Thank you as a reminder to ask a question. Please press star one one on your telephone you will then hear an automated message advising better hand. This race 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 W. B B Securities. Your line is open.
Yes, hi, thanks for taking the question.
In listening to the list of <unk>.
Trial approaches I'm seeing that everything is really adding to the current standard of care and all of these critical indications what kind of feedback are you getting from your clinician partners that you're working with on.
What theyre seeing the importance and how this basically works into what they've done in the past and I'll hop back into the queue. After that thank you.
Thanks, Steve Nice to talk to you and I. Appreciate your question so biff.
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, where which solid tumors, where the ones, where we could make the biggest difference and whether or not they felt that the approach that we were espousing actually with sensible to them and the feedback.
That we got done 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 too to potential market and faster to patients in the long run than brand new at CES that has to start.
Developing an FX efficacy profile from scratch and they also believe that in this pharmacodynamics challenging environments, 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 peptides and use it to significantly augment the efficacy of known drugs. Many of which are already generic <unk> 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 theres a strong sentiment among them that Lister one is doing exactly what we report it to do.
Can I check on one one agenda on the regulatory side given the fact that you obviously, it's one of the considerable hurdles in these spaces, what what do you see there in terms of the advantage and again this tunnel I will hop back in the queue.
Well I think the advantage from a regulatory perspective is to.
To some extent obvious when you are just adding something into an already existing regimen, and we and by adding I mean, we simply co administer these products. So there is no.
The only mixing if you will that takes place inside the body and that makes formulation and stability in all of those the chemistry and manufacturing control issues simpler to deal with these are not new chemical entities in the sense that we're not <unk> the anti cancer agents with lists to one 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 Lister. One ended up 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 <unk>.
In Australia, and we've just started our interactions with the EMA in Europe , and so far we.
We haven't seen any particular hurdles and the discussions are proceeding as we expected.
Got it okay. Thanks for taking the questions and let me hop back in the queue.
Thanks, Steve.
Commercial drug developer wouldn't do but they actually decided that they wanted to power the trial to determine you know some efficacy and points as well. So that was the trial that we inherited when when we looked at that trial.
So I said that was that was great, but there were at least one other thing that we saw it should've been done and that's the basic tenet of the of the amendment and that we added a second cohort of patients no very creatively called cohort D and that second cohort actually will receive.
Two doses of list the one separated by about four hours. So they still receive Jim side of eating that Paclitaxel and let's do one essentially co administered at the start but four hours later they'll get a second dose of <unk> and the reason for that is if you look at the pharmacokinetic profile.
<unk> see Max the T Max and the half life of these different compounds you realize that <unk> has a half life of roughly two hours or 90 minutes or something like that list. The one has a half life of about the same but now paclitaxel has a half life of about 10 to 12 hours.
So there was at least some thought process that said if you waited.
Two or more have lice after the first dose of list one.
Essentially you're outside the therapeutic range of list. The one Jim side of being is all gone, but you're still within the therapeutic range of <unk> and a second dose of list of one might provoke improved penetration of the remaining Nat paclitaxel into the tumor and might have a positive effect on.
Tumor efficacy. So so in some ways. This is part of what would be a typical phase to be trial and that we are 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 called courts against each other and then perhaps the <unk> 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 the what would be likely the phase three trial that would follow.
Great that's helpful. So <unk>.
You mentioned powering and I think registrational trial that.
That would seem to be.
So is it fair to say that that's possible, but low probability.
Yes, that's our that's our expectation is not that this will be a registration trial, but that it will be a a solid support for designing a registration trial that will go forward now that said, we will pursue every avenue with F D, a and especially the T. G. A in Australia, where the majority of the sites offer this trial.
To see if the data are positive and statistically significant if they would consider an accelerated path or conditional past two approval.
Super Thank you.
Thanks <unk>.
Thank you. Our next question comes from Pete Enderlin with modest partners. Your line is open.
Thank you hi, everybody.
Conceptually I thought originally the idea was that list of one could either be coding.
Co administer which is what is your just talking about or tether and you just said David David.
That's not really what you're anticipating now so.
Is it true that you're really not <unk>.
Contemplate let.
Let me clarify okay.
Okay. So so.
The the the two approaches either co administration are tethering remain distinct possibilities. Okay. I think you know in the past I've described the current administration approach as the rapid most rapid approach to a first registration for the reasons that I outline briefly.
A moment ago with with tethering, you create a new chemical entity that right to be fully characterized and you know both biologically and chemically and those are much you know you're basically starting from zero with that kind of a product with with co administration, you're basically starting using the knowledge base of the staff.
Standard of care and just standing onto it so it's a simpler faster most likely less expensive way to getting to answers into a registration 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.
Thanks for clarifying that and then.
Sort of looking several years ahead, but but that's what we try to do.
When 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 do you tie the sales and the pricing together or does each company sort of on its own and they're separate and independent for each each entity that you bring to the party and a particular application or indications for example, I mean, you've got a jump side I mean.
Paclitaxel and list of one and you can either have a package sale or salomon price them independently, so which where do you typically anticipate going so we would right now the anticipation is that this will be an add on to existing therapy and as I said.
You know those therapies could already be generic or could become generic by the time, we get to market, but our product will not be generic will still be under patent and and it will be priced accordingly, as an add on which augments efficacy of those less expensive and more you know try.
<unk> 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 in price them as a bundle because we wouldn't one the other products, we wouldn't be in a position to manufacture.
Then we could source for them and bundle them, but there's no real benefit necessarily to doing that and what we're doing is looking to create you know 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.
So you know we would price a deal for exclusivity appropriately in that case, so but in the initial agreements that you have with these other players.
Really spell out exactly what.
Any such.
Comedy.
Current agreements are are are essentially development agreements. They just say that we will work together to to demonstrate hopefully that the addition of list one improves the the products that are already considered standard of care and if that works as I said, you know that will be enough to improve everyone.
<unk> bottom line in the long run, but you know 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 right, okay, great. Thanks, a lot.
Sure.
Thank you next question comes from Joe Pant, Kenneth with H C. Wainwright Your line is open.
Everybody. Good afternoon. Thanks for taking the question two questions. If you don't mind day. So first you know 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 only driver for expensive, increasing but where do you currently stand on your current manufacturing needs for a list of one as well as your into room, two more longterm need.
Thanks, you too I appreciate the question and thanks for participating so S. S. I think you're 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 and and as I've mentioned I think in the past some of these.
Grams, or cofunded and and many of them are being operated in areas will will get R&D rebates, which contributes to a reduction in costs and some of them are completely funded by the other partner, but yet we retain rights to to our product with that said, we now can project with a fair degree.
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 and so that's into the early part of 2026 and all of the the things that we talked about <unk>.
Starting are already included in that as are all of the drug and manufacturing needs and including clinical supplies as well as the appropriate validations and stability manufacturing and lost to keep the C. M. C portion of development essentially in line with the clinical for.
<unk>.
That that's great to hear and then curious with all the programs that you discussed today, you know, which one of these indications have the or I'd say like the rate limiting step with regard to patient enrollment with regard to pay competing for patients with other studies.
Oh Wow there there are a fair number of pancreatic cancer studies ongoing in their studies in all these other solid tumors. So so we do have competition, but I think there's quite a bit of enthusiasm about our trial and you know what rather than sampling through this answer I'm Gonna I'm Gonna put Christian on the spot and see.
She can give some sense about what we think will be the toughest to enroll in and how we've constructed our enrollment projections.
Yeah. Thanks for the question and I'll start off Yeah, I'll start off by saying, we do have a lot in pancreatic cancer, but we've been very careful to not have them count.
Cannibalize each other such that.
Some as as you well know probably pancreatic cancer has two main standards of careful Sarah <unk> Paclitaxel. So we've tried to exploit both of those standards of care such that those who are eligible for <unk> will have a separate trial and those who are eligible for gymnasts or in a separate trial and then in one of our pancreatic try.
Giles we are doing non resectable locally advanced such that we could change a <unk> tumor that is non resectable and make it resectable. So that's a different patient population for the essential while there really isn't competition because it is occurring in Australia. So if I were to answer the second question, which is the hardest to recruit.
<unk>.
I would say one of the arms of the bolster trial may be difficult to reach to recruit which is esophageal <unk> excuse me esophageal carcinomas 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 <unk>.
Parts of Europe to recruit this trial, but for the most part we've been very diligent and strategic in choosing our patient populations such that we wouldn't internally cannibalize each each of our trials.
Got it I appreciate all the color.
You're welcome.
Thank you. Our next question is a follow up from Pete and Orlando with them as partners. Your line is open.
Yeah, just a quick one.
What do you have in the way of Ah Ah remaining New Jersey tax Nol's and Uhm, what would be the timing of their availability.
So thank god to play the juice of those [laughter], okay, well the contemplated uses easy we apply that to you know what what generally characterize as Joan.
How how soon you take advantage of that minority, here's a or whatever but.
Alright, so we have.
Approximately 12 O $2 million to $3 million left under the current program, which which caps every company at $20 million lifetime benefit that could change it's already changed once two years ago from 15 to 20 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 you know 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 that's roughly at somewhere between one to one and a half.
<unk> dollars a year over the next two years is what remains in terms of current eligibility.
Well every bit helps.
Excellent okay. Thank you.
Thank you. This concludes the question and answer session <unk> back over to Doctor Mazzo for closing remarks.
Thanks upgrade or and again, thank you all for participating to today's call and I really appreciate it the the questions that gave us the opportunity to provide some additional color. We look forward to speaking with you again during the next quarterly conference calls and continuing to provide updates on our achievements in progress we remain grateful for your continued interest and support in Masada.
And we wish you a very good evening, thank you and goodbye.
Thank you for your participation. This does include the program you may now disconnect everyone have a great day.
Mmm.
[music].