Q3 2024 Lisata Therapeutics Inc Earnings Call
Okay.
Welcome to the list.
Third quarter two.
Financial results and business update conference call.
Currently all participants are in a listen only mode.
Following managements prepared remarks, we will hold a Q1.
To ask a question at that time. Please press star one on your telephone you will then hear an automated message advising your hand is raised as are we.
Reminder.
This call is being recorded today Tuesday November 12 2024.
Speaker Change: I would now like to turn the call over to John Lindsay.
Speaker Change: This president of Investor Relations and corporate communications at <unk>. Please go ahead Sir.
Speaker Change: Yeah.
Speaker Change: Thank you operator, and good afternoon, everyone welcome to <unk> third quarter 2024 conference call to discuss our financial results and to provide a business update.
Speaker Change: Joining me today from our management team are Dr. David Mazzo, President and Chief Executive Officer, Dr. Christian <unk> Executive Vice President of research and development.
Chief Medical Officer, and James <unk>, Senior Vice President of Finance, and Treasury and Chief Accounting Officer.
Shortly before this call we issued a press release announcing our third quarter 2024 financial results, which is available under the investors and news section of the company website, along with the webcast replay of this call.
Speaker Change: If you have not received this news release or you'd like to be added to the company's email distribution list. Please subscribe to our email alerts on the company website or email me at Jason <unk> at <unk> Dot com to be added.
Speaker Change: Before we begin I remind you that comments made by management. During this conference call will contain forward looking statements that involve risks and uncertainties regarding the operations and future results of the startup.
Speaker Change: I encourage you to review the company's filings with the Securities and Exchange Commission, including without limitation. Its forms 10-Q, 8-K, and 10-K, which identifies specific risk factors that may cause actual results or events to differ materially from those described in the forward looking statements.
Speaker Change: Furthermore, the content of this conference call contains time sensitive information that is accurate.
Speaker Change: As of the date of this live broadcast Tuesday November 12 2024.
Speaker Change: <unk> Therapeutics undertakes no obligation to revise or update any statements to reflect events or circumstances. After the date of this conference call.
Speaker Change: With that I'll now turn the call over to Dr. Mazzo Dave.
Speaker Change: Thank you John and good afternoon, everyone. It is my pleasure to be here today to provide an overview of recent business highlights discuss our third quarter 2024 financial results and give an update on the progress of our development programs.
Speaker Change: Through the first nine months of 2024, we continued our progress in advancing development of <unk> in combination with a variety of anti cancer agents with different modalities for the treatment of advanced solid tumors.
Speaker Change: The ongoing accumulation of both preclinical data and early clinical data support our belief that took appetite has the potential to become an integral part of our revised standard of care treatment regimen for advanced solid tumors, including pancreatic cholangiocarcinoma glioblastoma colon appendiceal and melanoma.
Speaker Change: Additionally, we have initiated a preclinical investigation of <unk> as a potential therapeutic agents outside of oncology in the treatment of endometriosis, a disease, which affects hundreds of millions of women worldwide and for which the remains a pronounced unmet medical need.
Speaker Change: Christopher Buck, our Chief Medical Officer, and head of R&D will provide a detailed update of our ongoing and planned clinical and preclinical programs. Following the review of our financial results with that I will now turn the call over to James to discuss our senior Vice President of Finance and Treasurer, and Chief Accounting Officer James.
James: Thanks, Steve Good afternoon, all I am pleased to join you today to present, a summary of our third quarter 2024 financial results starting.
James: Starting with operating expenses.
James: The three months ended September 32024, operating expenses totaled $5 3 million compared to $6 million for the three months ended September 32023, representing a decrease of zero point $6 million or 10, 5%.
James: Research and development expenses were approximately $2 5 million for the three months ended September 32024, compared to $3 4 million for the three months ended September 32023.
James: Representing a decrease of zero point $8 million or 24, 8%.
James: This was primarily due to a reduction in clinical research organization expenses associated with our phase Iia bolster trial as a result of trial protocol modifications and lower equity expense.
James: Also impacting this.
James: This decrease were startup expenses in the prior year related to our Glioblastoma multi form study.
James: General and administrative expenses were approximately $2 8 million for the three months ended September 32024, compared to $2 6 million for the three months ended September 32023.
James: Representing an increase of 0.2 million or eight 1%.
James: This was primarily due to higher consulting expenses overall.
James: Overall net losses were $4 9 million for the three months ended September 32024, compared to $5 3 million for the three months ended September 32023.
James: It is noteworthy that we continue to make progress according to our plans for our R&D and business activities, while still continuing our legacy of prudent capital management and expense minimization.
James: Turning now to our balance sheet and cash flow.
James: As of September 32024, Masada had cash cash equivalents and marketable securities of approximately $35 9 million base.
Based on its current expected capital needs. The company believes that its projected capital will fund. Its current proposed operations into early 2026, encompassing anticipated data milestones from all its ongoing and planned clinical trials.
Speaker Change: With that I will now turn the call over to Dr. Christopher Buck to provide an overview of the company's development programs President.
Speaker Change: Thank you James and good afternoon, everyone.
Speaker Change: Before I review, our development portfolio allow me to summarize some important background information, especially for those who are listening for the first time.
Speaker Change: Despite advances in cancer therapy, many solid tumors are still associated with poor patient outcomes at.
Advanced solid tumors, such as pancreatic cancer gastric cancer and Glioblastoma multi form are surrounded by a dense fibrotic tissue known as the stroma, which limits access of most pharmacotherapy is into the tumor.
Speaker Change: In addition, many solid tumors also harbor, a hostile tumor microenvironment or <unk>.
Speaker Change: Which suppresses the patient's immune system and makes it less effective in fighting the cancer.
Speaker Change: The combination of a dense stroma and a hostile tumor microenvironment prevents many chemotherapies and immunotherapies from being optimally effective in treating these cancers.
Speaker Change: This coupled with the fact that most anti cancer therapies are not efficient and targeting only cancerous tissue defines the major challenges in the treatment of solid tumors.
Speaker Change: To overcome these obstacles our investigational product search peptide leverages the naturally occurring send our active transport system to selectively deliver anti cancer drugs through the stroma into the tumor.
Speaker Change: Simultaneously certain hepatitis has been shown to modify the tumor microenvironment, making it less immunosuppressive and therefore, increasing the tumors susceptibility to immunotherapy and our body's own immune system, while also inhibiting the metastatic cascade.
Speaker Change: For more specifics regarding certain hepatitis mechanism of action.
Speaker Change: Might you to visit our website and view the animated video proceeding there too as well as the relevant slides in our corporate presentation.
Speaker Change: Beyond our strategic clinical development plan, we are focused on optimizing our regulatory strategy to date. Our approach has yielded significant results for certain hepatitis with multiple special regulatory designations across health authorities.
Speaker Change: These include orphan drug designation fast track designation and rare pediatric disease designations.
Speaker Change: One such achievement occurred this past September when certain hepatitis was granted orphan drug designation by the U S food and drug administration for the treatment of Cholangiocarcinoma.
Speaker Change: As mentioned, our regulatory and clinical development strategy for certain appetite prioritizes rapid registration.
Speaker Change: We are actively evaluating certain hepatitis potential as a selective tumor targeting and penetrating enhancer and tumor microenvironment modifier in combination with a variety of standard of care therapies in advanced solid tumors.
Speaker Change: Now for an update on our individual development programs.
Speaker Change: The ascend trial is a 158 patient double blind randomized placebo controlled clinical trial evaluating certain hepatitis in combination with standard of care.
Speaker Change: <unk> Gemcitabine and Nab Paclitaxel chemotherapy.
Speaker Change: In patients with metastatic pancreatic ductal adenocarcinoma or M P deck.
Speaker Change: Excuse me.
Speaker Change: The trial is being conducted at 25 sites in Australia, and New Zealand led by the Austral Asian, gastrointestinal clinical trials group or Agi T G.
Speaker Change: In collaboration with the NIH MRC clinical trial center at the University of Sydney.
Speaker Change: As mentioned on prior calls the central is an investigator initiated trial that Lasalle inherited upon our acquisition of <unk> therapeutics.
Speaker Change: After the acquisition, we started collaborated with the sponsor of the trial Agi T G.
Speaker Change: To modify the trial to ensure it provided clinical outcomes that would best support the next steps in development of certain appetite from a regulatory perspective.
Speaker Change: As such the ascend protocol was amended to include another cohort of patients cohort b.
Speaker Change: Cohort B is designed to evaluate a second dose of intravenous or hepatitis given four hours. After the first thereby enabling further sure turpentine dose exploration and optimization.
Speaker Change: The ascend protocol was also amended to capture overall survival outcomes for both cohort a and cohort b.
Speaker Change: Given that the ascend protocol was amended following trial initiation.
Speaker Change: The outcome data from cohort B will be delivered months after cohort a data.
Speaker Change: Cohort a data excuse me cohort a reached a predetermined number of events in September of this year, which prompted a preliminary analysis of the data.
The results of that analysis were submitted as an abstract for <unk>, which takes place in January 2025.
Speaker Change: We just recently learned the abstract was accepted and the preliminary results of cohort eight will be presented by the study's sponsor at the conference.
Speaker Change: As a reminder, the sponsor has sole ownership and control of the data dissemination.
Speaker Change: That said, we are in discussions with them to see if we could communicate any information from the preliminary analysis prior to the conference without diminishing the integrity of the abstract and presentation.
Speaker Change: As it stands right now however, we will most likely need to wait until the time of the conference before communicating any preliminary results publicly.
Speaker Change: As noted we anticipate cohort b is trailing cohort eight in time and those data are expected to be mature and available mid 2025 with a final analysis, including both cohorts a and b available thereafter.
Speaker Change: The bolster trial is our phase Iia double blind placebo controlled multicenter randomized trial in the United States evaluating certain peptide in combination with standard of care in first line and second line Cholangiocarcinoma.
Speaker Change: Enrollment was completed in first line Cholangiocarcinoma nearly six months ahead of time.
Speaker Change: Accelerating the anticipated top line data read out to mid 2025.
Speaker Change: Our second cohort has been added to the bolster trial evaluating certain peptide in subjects in second line Cholangiocarcinoma on top of standard of care.
Speaker Change: We've now treated several patients in the second line Cholangiocarcinoma cohort and enrollment completion is expected in the first half of 2025.
Speaker Change: Send to Fox is a phase one b two way open label trial and trial in the United States evaluating certain appetite in combination with neo adjuvant fulfill <unk> based therapies in pancreatic colon and Appendiceal cancers.
Speaker Change: The trial has completed enrollment in the pancreatic cohort and remains on track to complete enrollment in the remaining two cohorts by the end of this quarter.
Speaker Change: <unk> pharmaceutical the licensee of certain hepatitis in the greater China Territory is also currently evaluating certain hepatitis in combination with Gemcitabine and Nab paclitaxel as a treatment for metastatic pancreatic cancer.
Speaker Change: Sheila was currently treating patients in their phase two placebo controlled trial in pancreatic cancer. This study is planned to take approximately 18 months to complete enrollment accrual and another 13 months for patient follow up and data analysis and reporting.
Speaker Change: Okay.
Speaker Change: In collaboration with Astrazeneca, Australia, and the funding sponsor of the I list the trial work nine.
Speaker Change: We are evaluating certain appetite in a phase one b two way randomized placebo controlled three arm single Blind single Center safety early efficacy and Pharmacodynamic trial.
Speaker Change: The trial is being conducted in Australia evaluating certain appetite in combination with a checkpoint inhibitor to have allomap plus standard of care Gemcitabine and Nab Paclitaxel chemotherapy <unk>.
Speaker Change: First is <unk> in combination with standard of care alone No dorval, a mab versus standard of care alone in patients with locally advanced non resectable pancreatic cancer.
Speaker Change: Enrollment completion is expected in the first half of 2025 and preliminary results are expected to be announced at <unk> Gi in January 2025.
Speaker Change: Okay.
Speaker Change: The study of certain peptide in combination with team is Ola Meyer in Glioblastoma multi form or GBM has been initiated with several patients already enrolled and treated.
Speaker Change: This study is designed as a phase two a double blind placebo controlled randomized proof of concept study evaluating certain peptide when added to standard of care team is all in line.
Speaker Change: Versus team is all mine alone and matching certain hepatitis placebo in subjects with newly diagnosed GBM.
Speaker Change: This actively enrolling study is being conducted across multiple sites in Estonia, and Latvia and is targeted to enroll 30 patients with a randomization of two to one <unk> plus standard of care versus placebo plus standard of care.
Speaker Change: Enrollment completion is expected in the second half of 2025.
Speaker Change: Four to five is a phase one b to a double blind placebo controlled three arm randomized study in the United States evaluating the safety Tolerability and efficacy of a four hour continuous intravenous infusion of certain peptide in combination with standard of care in patients with <unk>.
Speaker Change: Second line metastatic pancreatic cancer, who have previously progressed on fulfill remarks.
Speaker Change: As part of this study we have engaged haystack oncology to use their MLR D technology.
Speaker Change: To measure circulating tumor DNA levels at multiple time points and patients throughout the study as an exploratory endpoint for analyzing the early therapeutic effect of certain peptides.
Speaker Change: We expect to enroll the first patient in this study in the first quarter of 2025.
Speaker Change: Additionally, Lasalle has recently entered into multiple preclinical research collaborations to broaden our understanding of certain hepatitis therapeutic potential and identify not new non oncologic opportunities for this development. These collaborations include.
Speaker Change: A sponsored research agreement with the University of Cincinnati to assess certain appetite in combination with Bevacizumab.
Speaker Change: Our veg F inhibitor in a preclinical murine model for the treatment of endometriosis.
Speaker Change: This trial is the first exploration of certain appetite and a non oncologic or cancer related indication.
Speaker Change: Yeah.
Speaker Change: Our partnership with Veilleux therapeutics to investigate the benefits of combining search hepatitis with veloz peptic, Fred a customizable uncle Lytic adenovirus platform technology, and a checkpoint inhibitor in a preclinical murine model for the treatment of melanoma.
Speaker Change: Beyond the studies I've outlined we are actively exploring additional opportunities to advance our development strategy. However, we remain focused on only initiating trials that can be funded through data and that can be executed within a reasonable period of time.
Speaker Change: As a reminder, several of the clinical study as I mentioned earlier are investigated investigator initiated trials and although we have great confidence in the investigators running. These studies Masada has limited control on the timelines and expectations may be subject to change.
Speaker Change: That said, we are extremely grateful to the investigators and especially to the patients participating in certain appetite clinical trials around the world.
Speaker Change: For those who are interested in a more comprehensive description of each trial is available in the appendix section of the corporate presentation on our website.
Speaker Change: Additionally, in the body of the presentation. There are two slides that deepak the anticipated timing and execution of key milestones and data readouts from our trials as.
Speaker Change: As you will see there are numerous.
Speaker Change: Execution and data milestones projected from our portfolio of clinical trials over the next year and beyond.
Dave: With that I will now turn the call back to Dave.
Dave: Thanks Kristen.
Dave: As you've heard we have a lot going on and I'm looking forward to a data rich period, starting in the very near future.
Dave: We remain optimistic about the potential of suits appetite to transform the lives of patients with cancer and have demonstrated our ability to design and execute a very capital efficient development plan. However, as I've mentioned before we continue to be frustrated as I am sure. All of you are with our share price and our market valuation.
Dave: Wondering a robust advancing clinical development portfolio focused and rational development and regulatory strategy continually growing library of supportive evidence and impeccable capital stewardship trading at a negative enterprise value is irrational and misleading.
Look forward to seeing a market reaction to our upcoming data that reflects what we see is the true value of our development candidate and company.
Dave: We remain committed to advancing this hepatitis program across multiple tumor types and exploring strategic partnerships to maximize its value.
Dave: We look forward to sharing further updates on our progress throughout the year.
Speaker Change: Operator, we're ready to take questions.
Thank you as a reminder to ask a question. Please press star one on your.
Speaker Change: Telephone you will hear an audit makes automated message advice in your hand, just raised one moment for the first question.
Speaker Change: And our first question today will be coming from Joseph.
Speaker Change: Pan Guinness of <unk>.
H C. Wainwright your line is open.
Speaker Change: Hi, Good afternoon. This is Sarah on for Gil Thanks for taking the question.
Speaker Change: I had a question regarding enrollment and GBM study.
Speaker Change: In your last update I believe you had mentioned you had enrolled three patients and I know.
Clinical sites have opened since I was wondering if you can give any insight into maybe how many patients are currently enrolled in the study and how exactly it's progressing thank you.
Speaker Change: Thanks for that I appreciate you joining and thank you for the question our GBM trials.
Speaker Change: <unk> gotten off to a little bit slower start than we expected, mostly because the sites in Latvia, which were intended to provide the lion's share of the patients ended up taking a bit longer several months longer to initiate than was previously expected.
The study insight, though is now up to five patients.
Speaker Change: The Lafayette sites should be coming online soon and we certainly hope to have enrollment to meet our expectations for completion as indicated on a milestone slide so thank you very much.
Speaker Change: Thank you.
One moment for the next questions.
Speaker Change: And our next question will be coming from the line of Steve Brozak of <unk> Securities. Your line is open.
Speaker Change: Yes, hi, thanks for taking the question questions.
Speaker Change: Yeah.
Speaker Change: Alluded to in endometriosis.
Speaker Change: Potential here.
Speaker Change: Kind of curious too and if you don't mind, just going over the commonality with what Youre looking at as far as certain appetite and what the common characteristics are and why this is not just something that people should think about how it might extend to other things as well. So if you can provide as much.
Speaker Change: Detail.
Speaker Change: And what the mechanisms are whats youre looking at that would be greatly appreciate it and I've got a follow up after that please.
Speaker Change: Steve This is Christian I will take that endometriosis is a tumor like disease, it's a disease of angiogenesis, whereby menstrual material escapes the uterus and goes into the peritoneal cavity.
Speaker Change: We're targeting endometriosis, one because it's a significant unmet medical need with over 190 million women suffering from it worldwide for things like pain discomfort and even in fertility, but two because endometriosis has up regulated receptors required for certain hepatitis selective targeting and penetration and.
Speaker Change: That's the integrin and the neuro pillar one.
Speaker Change: And so we're trying to assess whether we can stop the angiogenesis of endometriosis by co administering <unk> hepatitis with an anti vascular endothelial growth factor VEGF anti VEGF.
In doing so we hope that we can.
Speaker Change: Have a a.
Speaker Change: A viable treatment option for these 190 million people worldwide worldwide.
Speaker Change: Okay.
Speaker Change: I have a follow up on that and I'd like to the floor.
Speaker Change: And how you've described it what is the current standard of care.
Is used.
And dealing with endometriosis and I've got one follow up I was planning on after that please.
Steve: Sure Steve a lot of it starts with nonsteroidal anti Inflammatories analgesics, hormonal modulators and at worst case surgery to the bulk of the endometrial lesions.
Theres really no cure for this disease and as I said, it's a very very big unmet medical need.
Speaker Change: Okay. Thank you, okay going back to on the Trialing.
Speaker Change: I know that you know obviously the trials what is and what is release to specifically dictated.
By the clinicians the lead investigators but.
Speaker Change: In terms of what you've seen as far as patient enrollment because this is one thing that no.
Speaker Change: No.
Speaker Change: Having done this for a long long time patient enrollment sometimes is a problem and other times. It's you usually meet it.
Speaker Change: How would you.
Speaker Change: Explain the patient enrollment that you've seen.
Speaker Change: On your on the major trials that you've got right now by comparison to the normal enrollment and I'll hop back back in the queue. After that thank you.
Speaker Change: Thank you, Steve I'll I'll speak a little bit to ascend and then Christian can speak to bolster and any others that she wishes to mentioned, but the center aisle enroll 150.
Christian: <unk> 58 patients over the course of about a year and a half which was actually a pretty good enrollment rate considering that it was all done amongst about 20 sites in Australia and New Zealand.
Christian: The investigators there the AG ITG consortium.
Christian: Our enthusiastic and obviously the patients where we're convinced to not only joined the trial, but to stay on treatment. So we take that as a positive sign that there's a great deal of both patient and investigator enthusiasm about the potential for the product.
Christian: I think it also speaks to switch appetites benign safety profile that well, we hope it has significant impact on augmenting efficacy of the co administered drugs it actually does not.
Christian: Potentiate further adverse events and I think that's very very important for for patients who are taking side.
Kristen: Cytotoxic Kristen how about you speak to bolster please.
Kristen: Sure as I earlier spoke bolster our first line Cholangiocarcinoma cohort had 40 subjects.
Kristen: And we recruited those within about six months of time, which is extremely fast six months ahead of our projected recruitment timeline.
Kristen: The investigators were very eager and so much so that they requested that we continue to open that trial may get larger.
Kristen: And or add a second line cohort, which we have.
Kristen: The second line cohort for Cholangiocarcinoma is recruiting as expected it's slower than first line cholangiocarcinoma, because it's a subset of patients who have progressed after first line and yet still.
Kristen: Have performance status capable of going on a new treatment regimen. So unfortunately, these patients who reach second line often.
Kristen: Have very bad performance status and succumb to the disease very quickly.
Kristen: Just to answer your questions to simply our first line recruited six months ahead of time, our second line and bolster his recruiting as expected.
Speaker Change: Got it thank you I'll hop back in the queue.
Keith: Thanks Keith.
Speaker Change: Thank you one moment for the next question and as a reminder, if you would like to ask a question. Please press star one on your telephone.
Speaker Change: Our next question will be coming from Pete Enderlin of MAZ.
Speaker Change: <unk> partners your line is open.
Pete Enderlin: Thank you.
Pete Enderlin: Hello, everybody.
Pete Enderlin: I'd like to talk about the collaboration with Allo tax excuse me.
Pete Enderlin: You mentioned you have multiple kind of.
Pete Enderlin: Colorado collaborations and partnerships.
Pete Enderlin: And joint efforts.
Speaker Change: So the first question is how do you prioritize all of those operation all of those opportunities.
Speaker Change: And conceptually you could say take any kind of cancer.
Speaker Change: Sure.
Speaker Change: Each of the different.
Speaker Change: Drugs that are in development for that.
Speaker Change: Then each one of those is potentially an opportunity for enhancement.
Speaker Change: Hassan.
Speaker Change: Right.
Speaker Change: So that's the first question how do you.
Speaker Change: Prioritize.
Speaker Change: Pursuing those opportunities.
Speaker Change: And.
Can you give us some sense of how many do you see as realistic opportunities at this point.
Speaker Change: Uh huh.
Speaker Change: Start and then maybe Christian can add some color commentary.
Speaker Change: But the way the way we look at this as sort of a matrix. So.
Speaker Change: First as you said in principle, we could combine <unk> with any modality of anticancer agents chemotherapeutic in immuno therapeutic even a radiopharmaceutical MSR and eight nor antisense pharmaceutical et cetera.
Speaker Change: And so what we what we look for first of all.
Speaker Change: As Christian mentioned early on we only want to start trials, whether they are preclinical or clinical that will yield the data.
Speaker Change: Funding window, so there's no point, starting something that yield got it until 2026.
Speaker Change: We have cash until 2026, so we need to to prioritize things that are likely to be completed in the 2025 timeframe. So that we can use that data to further.
Speaker Change: Increase the enthusiasm around search appetite and convert that into funding opportunities. We also look at what the unmet medical need it would be in the indication of choice whether the competition is.
Speaker Change: Two strong for us, we're not whether the length or the duration of the credit of our clinical trial might take many many years would it be short. So we look for those places where the disease causes patients to progress <unk> come more quickly so that we can show a.
Improvement.
Speaker Change: The shorter period of time, and we also look at the likelihood of the various mechanisms of action with <unk> co administered drugs are being complementary and yielding a much better.
Speaker Change: Approach, so when we've put things through that matrix or that funnel.
Speaker Change: Many things fall out before they get to the end and the things that get to the end of the ones that we agree that our priority. We also obviously look for those things where the partner is either paying for most or all of the collaboration and all we have to do is provide switch appetite yet we still have access to the data.
Speaker Change: Christian would you like to add anything to that.
Christian: I think you said it well Dave.
Christian: Well, let me just ask a little bit of a follow up on that is.
Christian: So looking at that matrix, you said some of them obviously drop out for obvious reasons can you give us any sense of how many are kind of like live prospects at this point going forward.
Speaker Change: Well I mean, you can see that we're working we have ongoing trials in pancreatic cancer.
Speaker Change: And in <unk>.
The seal cancer colon cancer, Glioblastoma, Cholangiocarcinoma et cetera, there are a number of other cancers that we would like to do work and certainly we have a growing body of evidence that indicates that the combination of search appetite with immunotherapies really.
Speaker Change: We'll give.
Speaker Change: Those immunotherapies a much increased efficacy profile in comparison to those immunotherapies alone in these solid tumors and so there are quite a few opportunities along those lines and then as Christian pointed out we're looking at areas outside of oncology, where the disease behaves.
Speaker Change: Like a tumor and or has the requisite receptors to allow for the sweet hepatitis mechanism of action to be effective and so there are a bunch of things to be looking at there including opportunities in osteosarcoma, even some veterinary applications melon.
Speaker Change: Melanoma, there are quite a few possibilities right now our ability to pursue all of those is limited only by capital.
Speaker Change: Did you just sort of imply that.
Speaker Change: In oncology.
Speaker Change: Opportunities for <unk>.
Speaker Change: No therapy might be more promising than chemotherapy as a broad statement.
Speaker Change: I think thats, what I implied.
Speaker Change: Exactly the way I would.
Speaker Change: Might be but it's early days, yet, but we're seeing some really very very compelling preclinical and early clinical data that might lead us to that final conclusion.
Speaker Change: And then just.
Speaker Change: And the format with Val Tex the collaboration.
They do the test you'll provide the drug.
Speaker Change: And so as that.
Speaker Change: Our preferred way to go about this is that primarily for cash reasons or because it's just easier to have somebody else in.
Speaker Change: Has the bandwidth to do the clinical trials themselves.
In the case of Zillow.
Not a question of bandwidth as much as a question or both.
Speaker Change: In house expertise and actually availability. So all of our preclinical work. That's done for example in models with animals.
Speaker Change: Are done outside of the side, we do not have laboratories between after the animal testing in house and we don't have a preclinical group per se, so theyre done with academic collaborations.
Speaker Change: These were in some cases cro's veilleux actually has those capabilities in house and so they're able to do the experiment straight away because they have everything they need to answer what are what we would have to set up contracts with <unk>.
Speaker Change: Right Protocol. This is a model they have running all the time they have the availability of the animals and the expertise and so it was simpler for them to do it and that's also why it's less expenses because theyre going to do it in house with existing resources. So we really don't have to pay them for that.
Speaker Change: Okay, great. Thank you very much.
Speaker Change: Information.
Speaker Change: Thanks Pete.
Speaker Change: Thank you one moment for the next question.
Speaker Change: And our next question for today will be coming from well head.
Speaker Change: Bill.
Speaker Change: Of Buckeyes capital markets. Your line is open.
Speaker Change: Hi, Thank you for taking questions I had one question I know.
Speaker Change: You don't have I know you can't say much about the cohort data for the ascend trial, but Ken.
Speaker Change: Can you give us any idea of what level of detail, we should expect in the readout.
Speaker Change: I'm, assuming we're going to get some PFS.
Speaker Change: Data and what would you like to see to continue.
Speaker Change: <unk>.
Speaker Change: Thanks <unk> I appreciate the question. So you are right.
Speaker Change: Not at Liberty to say very much about the data because the data is not.
Speaker Change: Not ours.
Speaker Change: <unk>.
Speaker Change: But that said.
Speaker Change: Can look to the protocol, which is available publicly on clinical trials dot Gov and from that protocol you can see what were identified as the major endpoints and so those are the the endpoints are the data that you should expect to see or hear about so that would be progression free survival at six months versus.
Speaker Change: Treatment versus placebo.
Speaker Change: Median progression free survival and median overall survival.
Speaker Change: Or at least three things that you should see you should also expect to see.
Speaker Change: A number the number numerical count.
Speaker Change: Complete responses each group.
Speaker Change: And maybe.
Speaker Change: Partial responses and overall response rates as well.
So I would expect those things out of it at a minimum and those are really important for us.
We all know that any one of those pieces of data can be quite interesting, but there is a pretty.
Speaker Change: I would say reasonable probability that.
Speaker Change: That the regulatory standards for ultimate approval will remain consistent going forward and that regulatory standard is overall survival. So we'll be paying very close attention to overall survival and also the number of complete responses in the treatment group versus.
Speaker Change: As the placebo group as we determine what would be the next steps.
Speaker Change: And hopefully there will be next steps in the development of switch appetite in metastatic.
Speaker Change: <unk> pancreatic ductal adenocarcinoma.
Okay. Thank you.
Speaker Change: Yes.
Speaker Change: Thank you and that does conclude today's Q&A session and I would like to turn the call back over to Dr. Mazzo for closing remarks. Please go ahead.
Dr. Mazzo: Again, thank you all for participating in today's call. We look forward to speaking with you again during our next quarterly conference call and to continuing to provide updates on our achievements and progress we remain grateful for your continued interest and support please stay well and have a good evening.
Dr. Mazzo: Yes.
Speaker Change: That concludes today's conference call you may all disconnect.
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