Full Year 2024 Lisata Therapeutics Inc Earnings Call
Okay.
Speaker Change: Welcome to the Lasalle therapeutic school year 2024 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&A session.
Speaker Change: Ask a question at that time. Please press star one on your telephone you will then hear an automated message advising that your hand is raised.
Speaker Change: As a reminder, this call is being recorded today Thursday February 27, 2025, I will now turn the call over to John Mendieta, Vice President of Investor Relations and corporate Communications at Masada. Please go ahead Sir.
Speaker Change: Thank you operator, and good afternoon, everyone welcome to the starters.
Speaker Change: For year 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.
Speaker Change: Dr. Christian Buck Executive Vice President of research and development and Chief Medical Officer, and James <unk>, Senior Vice President of Finance, and Treasurer, and Chief Accounting Officer.
Speaker Change: Shortly before this call we issued a press release announcing our full year 2024 financial results, which is available under the investors and news section of the company's website along with the webcast replay of this call.
Speaker Change: If you have not received this news release or if you'd like to be added to the company's email distribution list. Please subscribe to the email alerts on the company website or email me at Jason detail at Lasalle Dot com.
Speaker Change: Before we begin our mind 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 Masada.
Speaker Change: Courage 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 only as of the date of this live broadcast Thursday February 27th 2025.
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 with that I'll now turn the call over to Dr. Mazzo Dave.
Speaker Change: Thank you John and good afternoon, everyone. It's a pleasure to be here again to provide an overview of <unk> recent business highlights discuss our full year 2024 financial results and give an update on the progress of our development programs.
Speaker Change: Over the course of 2024 and now into early 2025, we have advanced our development portfolio centered around our novel product candidates to hepatitis for the treatment of advanced solid tumors and other difficult to treat diseases.
Speaker Change: The ongoing accumulation of both preclinical data and early clinical data supports our belief that <unk> has the potential to become an integral part of our revised standard of care treatment regimen for advanced solid tumors, including pancreatic cancer, Cholangiocarcinoma Glioblastoma colon cancer Appendiceal cancer and.
Speaker Change: Melanoma.
Speaker Change: We were particularly encouraged by the preliminary results from cohort eight.
Speaker Change: At the ascend trial and the I listed trials presented at the 2025 at <unk> Gi Symposium in January.
Speaker Change: These data while early provide further validation of the hepatitis potential and reinforced our conviction that <unk> could become a critical component of future treatment regimens for these devastating cancers.
Speaker Change: We are working diligently to advance these studies and explore additional anticancer combination treatment strategies.
Beyond oncology. We are also excited about the potential so tepid tied in other therapeutic areas.
Speaker Change: We have initiated the preclinical investigation absolute appetite as a potential therapeutic agent for the treatment of endometriosis, the disease, which affects hundreds of millions of women worldwide and for which there remains a pronounced unmet medical need.
Speaker Change: Looking ahead, we anticipate 2025 will be a data rich year for the startup we have several key milestones on the horizon, and we will share our progress and key findings as they become available following the review of our financial results Dr. Christopher Buck, Our Chief Medical Officer, and head of research and development will provide a detailed update on our ongoing.
Speaker Change: Planned clinical and preclinical programs, including timelines and key objectives with.
James: With that I will now turn the call over to James <unk>, Our senior Vice President of Finance, and Treasurer, and Chief Accounting Officer James.
James: Thanks, Dave Good afternoon, all I am pleased to join you today to present, a summary of our full year 2024 financial results.
James: Starting with operating expenses for.
James: For the year ended December 31, 2024 revenue totaled $1 million in connection with an upfront license fee related to the exclusive license and collaboration agreement with <unk> Labs, Inc.
James: The company did not have any revenue for the year ended December 31 2023.
For the year ended December 31, 2024, operating expenses totaled $23 4 million compared to $25 7 million for the year ended December 31 2023.
James: Representing a decrease of $2 3 million or eight 9%.
James: Research and development expenses were approximately $11 3 million for the year ended December 31, 2024, compared to $12 7 million for the year ended December 31, 2023 Rep.
James: Representing a decrease of approximately $1 4 million or 11%.
James: This was primarily due to a reduction in expenses associated with the phase two b ascend trial, which completed enrollment in the prior year.
James: Lower spend on chemistry manufacturing and controls and lower equity expense.
James: General and administrative expenses were approximately $12 1 million for the year ended December 31, 2024 compared to $13 million for the year ended December 31 2023.
James: Representing a decrease of approximately zero 0.9 million or six 9%.
James: This was primarily due to one off related severance costs in the prior year associated with the elimination of the Chief business officer position on May one 2023.
James: A reduction in equity expense, a decrease in directors and officers officers insurance premiums and a reduction in spend on legal fees, partially offset by one off settlement related cost and an increase in consulting expenses.
James: Overall, net losses were $20 million and $20 8 million for the years ended December 31, 2024, and 2023, respectively.
James: It is noteworthy that we continue to make progress according to our plans for our R&D and business activities, while continuing our legacy of prudent capital management and expense minimization.
James: Turning now to our balance sheet and cash flow.
James: As of December 31, 2024, we had cash cash equivalents and marketable securities of approximately $31 2 million.
James: Based on Lasalle is existing and planned activities. The company believes available funds will support current operations into the second quarter of 2026.
James: Lastly, an update regarding the net operating loss sale.
James: Earlier this year, we received <unk> 9 million and non dilutive funding as an approved participant of the technology business tax certificate transfer program.
James: Sponsored by the New Jersey Economic development Authority.
James: The program enables qualifying new Jersey, based biotechnology or technology companies to sell a percentage of their new Jersey, net operating losses, and research and development tax credits to unrelated qualifying corporations with the lifetime cap on the tax benefit sales of 'twenty.
James: Yes.
James: To date under the program, we have sold $19 6 million in tax benefits for net proceeds of $18 4 million.
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 Kristen.
Christopher Buck: Thank you James and good afternoon, everyone before I review, our development portfolio allow me to summarize some important background information, especially for those who are listening to me for the first time.
Christopher Buck: Despite advances in cancer therapy, many solid tumors are still associated with poor outcomes.
Christopher Buck: 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 to the tumor.
Christopher Buck: In addition, <unk>.
Christopher Buck: Many solid tumors also harbor, a hostile tumor microenvironment, which suppresses a patient's immune system and makes it less effective in fighting cancer cells.
Christopher Buck: The combination of a dense stroma and a hostile tumor microenvironment prevents many chemotherapies and immunotherapies from being optimally effective in treating these cancers.
Christopher Buck: This coupled with the fact that most anti cancer therapies are not efficient in targeting only cancerous tissue.
Christopher Buck: <unk> the major challenges in treating solid tumors.
Christopher Buck: To overcome these obstacles, our investigational products or capitate leverages the naturally occurring <unk>.
Christopher Buck: Our active transport system.
Christopher Buck: Selectively deliver anti cancer drugs through the tumor stroma and into the tumor.
Christopher Buck: Simultaneously <unk> 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.
Christopher Buck: While also inhibiting the metastatic cascade.
Christopher Buck: For more specifics regarding certain hepatitis mechanism of action I invite you to visit our website and view the animated video pertaining there too as well as the relevant slides in the corporate presentation.
Christopher Buck: Beyond our strategic clinical development plan, we are focused on optimizing our regulatory strategy.
Christopher Buck: To date, our approach has yielded significant results for should hepatitis with special regulatory designations across multiple health authorities.
Christopher Buck: These include several orphan drug designation fast track designation and a rare pediatric disease designation.
Christopher Buck: One such achievement occurred this past September winter turpentine was granted an orphan drug designation by the U S food and drug administration for the treatment of Cholangiocarcinoma.
Christopher Buck: As mentioned, our regulatory and clinical development strategy for <unk> prioritizes rapid registration.
Christopher Buck: 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.
Christopher Buck: Now for an update on our individual development programs.
Christopher Buck: The ascend trial is a 158 patient double blind randomized placebo controlled clinical trial evaluating <unk> in combination with standard of care, Jim <unk> and Nab paclitaxel chemotherapy in patients with metastatic pancreatic ductal adenocarcinoma.
Christopher Buck: The trials being conducted at 25 sites in Australia, and New Zealand led by the Australian gastrointestinal cancer trials group, our AG ITG in collaboration with the National Health and Medical Research Council clinical trial Center at the University of Sydney.
Christopher Buck: As mentioned on prior calls the ascend trial is an investigator initiated trial that Lasalle the inherited.
Upon our acquisition of <unk> therapeutics.
Christopher Buck: The original trial was designed with more of an academic nature, rather than one with commercial objectives and we statistically powered based on a six month progression free survival primary endpoint.
Christopher Buck: After the acquisition Masada collaborated with the sponsor of the trial AG ITG.
Christopher Buck: To modify the trial to ensure it provided clinical outcomes that will best support the next steps in development of certain appetite from a regulatory perspective.
Christopher Buck: As such the ascend protocol was amended to include an additional cohort of patients cohort b.
Christopher Buck: Not statistically powered to evaluate an additional <unk> dosing regimen.
Christopher Buck: The ascend protocol was also amended to capture overall survival outcomes for both cohort a and cohort b as overall survival is considered the gold standard endpoint in pancreatic cancer trials.
Christopher Buck: Since ESN protocol was amended following trial initiation data from cohort B is lagging cohort data by several months.
Christopher Buck: Cohort, a with 95 patients receiving a single IV dose of search hepatitis or placebo in combination with standard of care completed enrollment in the third quarter of 2023.
Christopher Buck: As recently announced preliminary cohort a data was presented at the 2025, ESCO Gi symposium, which showed a positive trend in overall survival, including four complete responses in the <unk> treated group compared to none in the placebo treated group.
Christopher Buck: Data from cohort B with 63 patients receiving two IV doses of certain hepatitis placebo administered four hours apart in combination with standard of care.
Christopher Buck: Are expected in the coming months with a final analysis of both cohorts available thereafter.
Christopher Buck: The bolster trial is our phase Iia double blind placebo controlled multicenter randomized trial of the United States evaluating certain hepatitis in combination with standard of care in first and second line Cholangiocarcinoma.
Christopher Buck: Enrollment was completed in first line Cholangiocarcinoma nearly six months ahead of plan accelerating anticipated top line data readout to mid 2025.
Christopher Buck: Our second cohort has been added to the bolster trial evaluating certain hepatitis subjects in second line Cholangiocarcinoma on top of standard of care.
Christopher Buck: With more than 30% of the patients enrolled in the second line Cholangiocarcinoma cohorts. We continue to target later this year for the completion of enrollment.
Christopher Buck: Yeah.
Christopher Buck: Send the Fox is a phase <unk> open label trial in the United States evaluating certain peptide in combination with neo adjuvant fulfill <unk> based therapies in pancreatic.
Christopher Buck: Colon and Appendiceal cancers.
Christopher Buck: In December 2024, the company announced enrollment and completion and all three cohorts.
Christopher Buck: This single Center study being conducted at the University of Kansas Cancer Center was designed with a three cycle for <unk> run in period to ensure patients met specific criteria before receiving treatment with certain appetite.
Christopher Buck: Of the 66 patients enrolled 50 met these criteria and were treated with certain appetite across three cohorts, including 24 with resectable or borderline resectable pancreatic cancer.
Christopher Buck: 15, with high grade colon, or Appendiceal cancer, and peritoneal metastases and 11 with a Lego metastatic colon cancer.
The trial will provide lossada with valuable pre and post treatment tumor tissue data for immuno profiling, along with long term patient outcome information.
Christopher Buck: We anticipate data in the coming months and we will share the key findings when available.
Christopher Buck: She Lou pharmaceutical the licensee of certain peptide in the greater China territory is also currently evaluating certain appetite in combination with Gemcitabine and Nab Paclitaxel.
Christopher Buck: As a treatment for metastatic pancreatic ductal adenocarcinoma.
Speaker Change: Sheila is currently treating patients in their phase III placebo controlled trial in pancreatic cancer.
Speaker Change: <unk> recently reported that they completed enrollment with the revised target enrollment of 96 patients.
Speaker Change: The revised study is still sufficiently powered and this change will expedite the study and allow for early earlier data analysis and preparation for our phase III trial.
Speaker Change: According to guidance from shallow data are expected in the next 12 to 18 months with a phase III study planned to start thereafter.
Speaker Change: In collaboration.
Speaker Change: <unk> with Astrazeneca in Australia, and the funding sponsor of the I listed trial work nine.
Speaker Change: We are evaluating certain appetite in a phase <unk> 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 the checkpoint inhibitor drove allomap plus standard of care Gemcitabine and Nab paclitaxel chemotherapy versus certain hepatitis in combination with standard of care No deer Valley map FERC.
Speaker Change: Standard of care alone in patients with locally advanced non resectable pancreatic cancer.
Speaker Change: Preliminary results from the first 17 of 30 patients enrolled in the <unk> trial were presented at the 2025 ASKO Gi symposium.
Speaker Change: The interim analysis suggests that <unk> in combination with standard of care chemotherapy and immunotherapy improve treatment outcomes for patients with locally advanced non resectable pancreatic cancer, while also provoking tumor infiltrating lymphocytes in subjects who have recessed.
Speaker Change: Responses.
Speaker Change: These findings also support preclinical data, indicating that <unk> enhances the effectiveness of immunotherapy.
Speaker Change: With 27 of the 30 targeted patients enrolled enrollment remains on track to be completed by the first half of 2025.
Speaker Change: A study of certain hepatitis combination with team is dolomite in glioblastoma multi form or brain cancer has been initiated with several patients already enrolled and treated.
Speaker Change: This study is designed as a phase Iia double blind placebo controlled randomized proof of concept study evaluating certain appetite when added to standard of care team as <unk> versus team is all up mind alone and matching certain hepatitis placebo in subjects with newly diagnosed glioblastoma.
Speaker Change: This actively enrolling study is being conducted across multiple sites and <unk> in Latvia and is planned to also include a site in Lithuania.
Speaker Change: The study 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 targeted for the second half of 2025.
Speaker Change: Fortified is currently planned to be 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 infusion of certain hepatitis in combination with standard of care in patients with.
Speaker Change: First line metastatic pancreatic cancer, who have progressed on <unk> excuse me second line metastatic pancreatic cancer, who have progressed on <unk>.
Speaker Change: As part of this study we have engaged haystack oncology to use their <unk> technology to measure circulating tumor DNA levels at multiple time points and patients throughout the study is an exploratory endpoint for analyzing the early therapeutic effect of certain hepatitis.
Speaker Change: Okay.
Speaker Change: The thought is currently evaluating alternative strategies to achieve the fortified study objective with a focus on identifying options that are faster <unk> less expensive.
Speaker Change: We hope to have more to share in the coming months.
Speaker Change: Additionally, <unk> recently entered into several preclinical research collaborations to further investigate the therapeutic potential of certain hepatitis.
Speaker Change: These collaborations encompass both oncology and other therapeutic areas and are intended to identify new strategic opportunities for the drugs development.
Speaker Change: These collaborations include.
Speaker Change: A sponsored research agreement with the University of Cincinnati to assessor tepid tied in combination with Bevacizumab.
Veg F inhibitor in a preclinical murine model for the treatment of endometriosis.
Speaker Change: This trial is the first exploration of certain hepatitis and in non cancer related indication and aims to assess if certain hepatitis can improve the delivery of bevacizumab to endometriosis lesions.
Speaker Change: <unk>, reducing lesion burdened in abdominal pain.
Speaker Change: Data from this preclinical trial are currently under review and while early signals are encouraging and suggest the potential for further investigation. The company will need to evaluate the financial resources required to determine the best path forward.
Speaker Change: Our partnership with Veilleux therapeutics to investigate the benefits of combining search hepatitis with veloz peptic Fred.
Speaker Change: A customizable ampholytic adenovirus platform technology.
Speaker Change: And a checkpoint inhibitor in a preclinical murine model for the treatment of melanoma.
Speaker Change: And as previously noted following results from an earlier preclinical study lossada entered into a global license agreement with Kouba labs to explore the synergistic potential of certain hepatitis as a targeting and delivery agent for <unk> nano Mark imaging technology in solid tumors.
Speaker Change: Cooper has communicated that it intends on commencing an imaging study in the first half of this year with results anticipated in early 2026.
Speaker Change: Relatedly methodical provisions are tepid tied to Cuba for its clinical study VA clinical supply agreement.
Speaker Change: This collaboration reinforces our belief in the broad applicability of certain hepatitis b honest therapeutic setting.
Speaker Change: Beyond the clinical studies I've outlined we are actively exploring additional opportunities to advance our development strategy, including progressing certain hepatitis in combination with Gemcitabine and Nab paclitaxel into a phase III study in pancreatic cancer. However.
Speaker Change: However, we remain focused on only initiating trials that can be funded through data with existing where guaranteed capital 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 I investigated investigator initiated trials and although we have great confidence in the investigators running these studies.
Speaker Change: Nevada has limited control and thus 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 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 the depict the anticipated timing and execution of key milestones and data readouts from our trial.
Speaker Change: As Dr. Mazo previously mentioned 2025 will be a data rich year for lasorda and we are looking forward to reporting those results.
Speaker Change: With that I will now turn the call back to Dave.
Dave: Thanks Kristen.
Speaker Change: Overall, we achieved our target milestones in 2024 positioning us well for continued success in 2025.
Speaker Change: Look forward to sharing further corporate and development updates throughout the year, including key information regarding our ongoing and planned trials as they become available. We believe that <unk> represents a significant opportunity to create both meaningful patient benefit and long term shareholder value.
Speaker Change: With that overview, operator, we're now ready to take questions.
Speaker Change: Thank you as a reminder to ask a question. Please press star one on your telephone you will there.
Speaker Change: Here, an automated message advising that your hand is raised each listener will be permitted to ask one question at a time and we will return to the queue for any additional questions.
Speaker Change: One moment for questions.
Speaker Change: Our first question comes from Cerro Nick with H C. Wainwright you May proceed.
Speaker Change: Hi, This is Sarah on for Joe can genus I have a question regarding the ascend trial I know you can't exactly speak to timing.
Speaker Change: But regarding the data cut that is expected from cohort b.
Speaker Change: Can you do you have any insight into what kind of data we could expect would it be along similar lines of what we saw earlier this year from cohort.
Speaker Change: Sure.
Speaker Change: Hi, Sir Thanks, very much for the question and giving me the opportunity to clarify for the cohort data, we expect something that would be akin to what was rep. What was reported for cohort cohort that is an analysis about the progression free survival and at least the preliminary if not final overall survival of all patients in.
Speaker Change: That cohort. So we're looking forward to that because those data will be indicative of final trial results and also will give us a good head start as the planning for phase III, assuming that they will be supportive.
Speaker Change: Okay. Thanks, that's helpful. Thank you.
Speaker Change: Thank you.
Unidentified Moderator: Our next question comes from Pete Enderlin with managed partners you May proceed.
Pete Enderlin: Hi, Hello, everybody. Thank you.
Unidentified Moderator: So just following up on that.
Speaker Change: Regard to.
Unidentified Moderator: Cohort B you said.
Unidentified Moderator: In coming months can you be a little more specific is that you hope by the end of the year or in the third quarter fourth quarter, what does that look like.
Speaker Change: So the best I can do Pete because.
Unidentified Moderator: As I think we've explained at least in writing.
Speaker Change: In the past that I can take a moment here to repeat it.
Speaker Change: Under contract with a G ITG and the CTC of the University of Sydney do not have any control over the release of the data right.
Speaker Change: First the Gator initiated set of trials and so they control the data release.
Speaker Change: First as we know right now the plans are to two attempts to have all of the analyses done in time to submitted abstract so that the data could be presented at the American society of clinical oncology or <unk> meeting, which is the last few days of May 1st few.
Speaker Change: Days of June this year, if they get their analyses done on time and submit that abstract then that would be the date of the public disclosure most likely.
Speaker Change: If they missed the deadline for the submission of the abstract that next relevant major.
Speaker Change: International scientific meeting.
Speaker Change: As ESMO, the European Society of medical oncology and that would be I think actually October so to narrow it down it's most likely going to be some time from.
Speaker Change: Second through third quarter of this year that the data will become available, although we're working with them that being the agi <unk> TTC to see if they can get the analyses done faster.
Speaker Change: And allow for release of the information under other circumstances. So that's the best we can say right now.
Speaker Change: Well, thanks, that's great.
Speaker Change: Actually we expected you to say <unk> in January of next year or so.
Speaker Change: That sounds very encouraging.
Speaker Change: That's a question that's a little bit.
Speaker Change: Yes.
Speaker Change: After brusca or whatever you want to call it and that is.
Speaker Change: When you reported.
Speaker Change: The cohort.
Speaker Change: Results preliminary data, it's about a month ago, the stock kind of severe reaction I think it's fair to say.
Speaker Change: So the question is what if anything that the street.
Speaker Change: Miss or misinterpret.
Speaker Change: What.
Speaker Change: It was really poor.
Speaker Change: But what is the street misunderstand or not quite.
Speaker Change: Realize when you report those results.
Speaker Change: Alright, well. Thanks also for the opportunity to speak to that remember I am.
Speaker Change: I can't speak for the Street, if you will or for any particular shareholders. So we'll just give our interpretation.
Speaker Change: What happened.
Speaker Change: There was a run up in value leading up to the date.
Speaker Change: <unk> announcements and I think there was a level of anticipation of what the data would would be.
Speaker Change: I expect that given the.
Speaker Change: The type of <unk>.
Speaker Change: Retail investors that we have.
Speaker Change: And the size of many of their holdings, which are relatively small that there was.
Speaker Change: Thank you for you if I can say expecting that we could make and announcements that would be earth shattering.
Speaker Change: Breakthrough.
Speaker Change: And when the data work.
Speaker Change: By their judgment Earth, shattering or breakthrough than they were disappointed.
Speaker Change: As we've said in our press release.
Speaker Change: The reason, we added cohort b was because we anticipated the type of results that we got out of cohort Hey, which is result that trend in the right direction are actually consistent with what we've seen in every other trial preclinical and clinically, but perhaps not full.
Speaker Change: Fully refined and that's because we were working on optimizing the dosing scheme and that's why we added cohort b in the first place.
Speaker Change: So for us it wasn't a big surprise, but I think for certain people, who perhaps didn't understand the nuances of the trial design were simply we're betting on.
Speaker Change: A big announcement.
Speaker Change: Thats why they were disappointed.
Speaker Change: It's unfortunate because the.
Speaker Change: It's the full trial accounts, not any bits and pieces.
Speaker Change: Yeah, Thanks that makes a lot of sense.
Speaker Change: And I'll just ask one more quick one sure go ahead and that as well.
Speaker Change: <unk> coover deal.
Speaker Change: Lead to let's say future diagnostics that will enable.
Speaker Change: <unk> analysis.
Speaker Change: Clinical trials phase III clinical trial that we would look at.
Speaker Change: Tumor sizes, and all that sort of suffered this is not really directly related to that.
Speaker Change: Once again I will give you my interpretation and conclusions based on the transaction with Cuba and discussions with their with their head, but I can't speak for <unk> to make that very very clear kouba speaks for themselves but.
Speaker Change: I believe that the intention with Cooper is to do exactly what you just described not only for clinical trials, but actually as a personalized medicine for treatment of actual patients once certain hepatitis approved so that the goal is to.
Speaker Change: Identify those patients.
Speaker Change: And those tumors.
Speaker Change: That are particularly susceptible to increased permeability in the presence of <unk>.
And therefore.
Speaker Change: Demonstrate though you or identify those patients who would respond better with search appetite in their anti cancer treatment regime. So I think that's exactly what they intend to do and I think we'll be doing it collectively both clinically and hopefully eventually commercially.
Speaker Change: Great Thanks, Dave and welcome to <unk>.
Speaker Change: Thank you.
Speaker Change: Okay.
Unidentified Moderator: Our next question comes from Steve Brozak with WPB Securities You May proceed.
Steve Brozak: Hey, guys. Thanks for taking the questions.
Steve Brozak: I do have a question and it's not about timing or outcome.
Steve Brozak: Say in terms of when when the data comes out but.
Steve Brozak: What are some of the what are some of the.
Steve Brozak:
Steve Brozak: Expectations not from yourselves, but what you have been talking to a number of pharmaceutical partners. What are they looking for in data that would appeal to them, obviously pancreatic cancer is a.
Steve Brozak: It's a critical disease.
Steve Brozak: Disease and its always found late and you obviously are looking at improving outcomes.
Speaker Change: Clinically in a significant fashion, what what can you tell us in any great granularity.
Speaker Change: Talking about timing that you would be looking that that pharmaceutical partners have told you that theyre looking for and I will hop back in the queue. Thank you.
Speaker Change: Hey, Steve Thanks, very much for joining and for the question. So in general what I'll say is not particularly profound because it would apply.
Speaker Change: Most of any oncology program at which a large pharma company would be looking and considering but in our particular case. What they are looking for are the complete trial results from the ascend trial for the reasons I just explained to the prior caller the complete trials with counts.
Speaker Change: And also a consistency of both therapeutic effect.
Speaker Change: And I.
Speaker Change: In safety and.
Speaker Change: So they want to know that the drug works consistently that we have a good handle on the relative magnitude of that effect. So that we can appropriately size and power and optimized phase III registration protocol and that there have been no untoward safety signals that have come out of.
Speaker Change: Exposure to larger populations.
Speaker Change: And so up until.
Speaker Change: Well, let's just say to date, we've been able to to do that and we'll be expecting to be able to do that hopefully with the results from cohort b when we get them and of course. This is all done in the context of in comparison with standard of care right. The whole point of the matter is that the addition of <unk>.
<unk> is designed to improve standard of care, so I'm talking about therapeutic effect I'm talking about the combination of the cytotoxic gemcitabine and Nab paclitaxel with with such appetite and seeing that they have an improved effect over treat.
Speaker Change: Treatment without sort of appetite.
Speaker Change: I for legal term for the purposes of clarity when you were talking about improvement.
Speaker Change: And obviously it isn't a laughing matter, we're talking about people who are predictably Unfortunately going to.
Speaker Change: To die.
Speaker Change: And you are looking at being able to improve those outcomes.
Speaker Change: Without getting too granular is that a fair statement.
Speaker Change: It is exactly the case, yes, sir.
Speaker Change: Okay, Let me hop back in the queue. Thanks for taking the questions.
Speaker Change: Okay.
Speaker Change: Yes.
Unidentified Moderator: Our next question comes from kept Oliver with Brookline capital markets. You May proceed.
Speaker Change: Alright, thank you.
Speaker Change: Most everything is pretty straightforward here, but you have an interesting comment about four to five trial.
Speaker Change: And alternative.
Speaker Change: Approaches to achieving this study objective.
Speaker Change: Our unique position to elaborate on any of that.
Speaker Change: Ken Thanks for joining and I. Appreciate your question. Thank you.
Speaker Change: I can say you know what were thinking originally to fortify trial was designed to elucidate elicit further information around the pharmacodynamics.
Speaker Change: So its appetite in humans and the original concept was that it would have to have its conclusions based upon.
Speaker Change: Both progression free survival and overall survival data in patients and as we know they take a long time to get to.
Speaker Change: And it's sort of a perverse situation, but the better the drug works the longer it takes to get that information and so we've been considering other ways and now that we have.
Speaker Change: Our strategic partnership with Coover it prompted the thought process around a possible.
Speaker Change: Means of eliciting the same information using imaging techniques in imaging endpoints for these purposes now we havent yet we find that we're certainly not in a position to discuss the protocol, but that's what we're talking about so if it if the idea works, we should be able to derive the type of information that we were looking to get from fortified.
Speaker Change: And fourth a fraction of the time and had a fraction of the cost and obviously that's very appealing.
Speaker Change: That's great. Thank you. Thank you Kevin.
Unidentified Moderator: Thank you. This concludes the question and answer session I will now turn the call back to Dr. Mazzo for any closing remarks.
Unidentified Moderator: Well again, thank you all for participating in today's call and we look forward to speaking with you again during our next quarterly conference call and are continuing to provide updates on our achievements and progress and we remain grateful for your continued interest and support stay well and please have a good evening.
Unidentified Moderator: Thank you. This concludes the conference. Thank you for your participation you may now disconnect.
Unidentified Moderator: Okay.
Unidentified Moderator: [music].
Unidentified Moderator: Okay.
Unidentified Moderator: Okay.
Unidentified Moderator: [music].
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