NASDAQ:LSTA Lisata Therapeutics Q3 2023 Earnings Report $2.26 +0.18 (+8.65%) Closing price 04/17/2025 03:56 PM EasternExtended Trading$2.12 -0.14 (-5.97%) As of 04/17/2025 05:40 PM Eastern Extended trading is trading that happens on electronic markets outside of regular trading hours. This is a fair market value extended hours price provided by Polygon.io. Learn more. Earnings HistoryForecast Lisata Therapeutics EPS ResultsActual EPS-$0.65Consensus EPS -$0.93Beat/MissBeat by +$0.28One Year Ago EPSN/ALisata Therapeutics Revenue ResultsActual RevenueN/AExpected RevenueN/ABeat/MissN/AYoY Revenue GrowthN/ALisata Therapeutics Announcement DetailsQuarterQ3 2023Date11/2/2023TimeN/AConference Call DateThursday, November 2, 2023Conference Call Time4:30PM ETUpcoming EarningsLisata Therapeutics' Q1 2025 earnings is scheduled for Thursday, May 8, 2025, with a conference call scheduled at 4:30 PM ET. Check back for transcripts, audio, and key financial metrics as they become available.Q1 2025 Earnings ReportConference Call ResourcesConference Call AudioConference Call TranscriptSlide DeckPress Release (8-K)Quarterly Report (10-Q)Earnings HistoryCompany ProfileSlide DeckFull Screen Slide DeckPowered by Lisata Therapeutics Q3 2023 Earnings Call TranscriptProvided by QuartrNovember 2, 2023 ShareLink copied to clipboard.There are 8 speakers on the call. Operator00:00:00Welcome to the TESARO Therapeutics Third Quarter 2023 Financial Results and Business Update Conference Call. Currently, all participants are in a listen only mode. Following management's prepared remarks, we will hold a Q and A session. As a reminder, this call is being recorded today, Thursday, November 2, 2023. I will now turn the call over to John Menditto, Vice President of Investor Relations and Corporate Communications at Lissata, please go ahead, sir. Speaker 100:00:38Thank you, operator, and good afternoon, everyone. Welcome to LASADA's Q3 2023 conference call to discuss our financial results and the opportunity to provide a business update. Joining me today from our management team are Doctor. David Mazzo, President and Chief Executive Officer Doctor. Kristin Buck, Executive Vice President of Research and Development and Chief Medical Officer and James Nisko, Vice President of Finance and Treasury. Speaker 100:01:04Shortly before this call, we issued a press release announcing our Q3 of the webcast replay of this call. If you have not received this news release or if you'd like to be added to the company's e mail distribution list, Please email me at jmandidolasada.com. 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 LASATA. I encourage you to review the company's filings with the 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 LASATA Therapeutics undertakes no obligation to revise or update any statements to reflect events or circumstances after the date of this conference call. Speaker 100:02:18With that, I will now turn the call over to Doctor. David Mazzo. Dave? Speaker 200:02:24Thank you, John, and good afternoon, everyone. Thank you for joining us today as we provide an overview of recent business highlights, discuss our Q3 2023 financial results and give an update on the progress of our various development programs. The Q3 was another productive quarter for LASATA as we added to the momentum of the first half of 2023 with the initiation and advancement of new clinical development programs targeting a variety of advanced solid tumors using LISTA-one, our lead product candidate in combination with multiple anticancer agents of differing modalities. As we have previously reported, We have both preclinical data and early clinical data in humans that we believe demonstrates the potential of Lista-one to become an integral part of a revised standard of care treatment regimen for many difficult to treat cancers. During this call, our Chief Medical Officer, Doctor. Speaker 200:03:17Kristin Buck, We'll provide an update on our clinical programs following the review of our financial results. And with that, I now will turn the call over to James Mitzko, our Vice President of Finance and Treasury. James? Speaker 300:03:31Thanks, Steve. Good afternoon, all. I'm pleased to join you today to present Summary of our Q3 2023 financial results. Starting with operating expenses. For the 3 months ended September 30, 2023, operating expenses totaled $6,000,000 compared to $37,700,000 for the 3 months ended September 30, 2022, representing a decrease of 84.2%. Speaker 300:04:00Excluding the in process research and development expense of $30,400,000 Related to our merger with Cen Therapeutics in September 2022, operating expenses decreased by $1,400,000 or 18.6% compared to the 3 months ended September 30, 2022. Operating expenses comprised the following. Research and development expenses were approximately $3,400,000 for the 3 months ended September 30, 2023 compared to $3,300,000 for the 3 months ended September 30, 2022, representing an increase of 1.3%. Expenses this The quarter were primarily due to study activities associated with the bolster trial here in the United States, Enrollment activities for the ASCEND study in Australia, start up activities for the glioblastoma multiform study in Europe and general chemistry, manufacturing and control activities for Lista-one to support all development General and administrative expenses were approximately $2,600,000 for the 3 months ended September 30, 2023 compared to $4,000,000 for the 3 months ended September 30, 2022, representing a decrease of 1,400,000 or 35.3%. This was primarily due to non recurring merger related costs in the prior year, A decrease in equity expense due to prior year performance stock unit vesting, merger option assumption expense and departing Board member restricted stock unit vesting and timing of our annual stockholder meeting versus the prior year. Speaker 300:06:08Overall, net losses were $5,300,000 for the 3 months ended September 30, 2023 compared to $37,400,000 for the 3 months ended September 30, 2022. Excluding the in process research and development expense of $30,400,000 related to our merger with CEN Therapeutics In September 22, net losses for the 3 months ended September 30, 2023 decreased by $1,700,000 or 24.7 percent compared to the 3 months ended September 30, 2022. Turning now to our balance sheet and cash flow. As of September 30, 2023, The company had cash, cash equivalents and marketable securities of approximately 54,400,000 The company remains confident that its projected capital will fund its current and proposed operations into early 2026, encompassing anticipated data milestones from all its ongoing and planned clinical trials. This completes my financial overview, And I will now turn the call over to our Chief Medical Officer, Doctor. Speaker 300:07:30Kristin Buck, for the review of our clinical development pipeline. Kristin? Speaker 400:07:37Thank you, James, and good afternoon, everyone. As those who have been following us know, LASATA's pipeline is built on a Portfolio of proprietary and patented technology that is grounded in strong scientific rationale and the body of published preclinical and early clinical data. Our platform technology is designed to address major impediments to the successful treatment of advanced solid tumors In an environment of increasing pharmacoeconomic pressures, generating meaningful clinical data is critically important in this field 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 an overview of List for the treatment of advanced solid tumors in combination with other anticancer agents. Despite advances in cancer therapy today, Many solid tumors remain difficult to treat effectively. Speaker 400:08:35Cancers such as pancreatic cancer, gastric cancers and other solid tumors are surrounded by a dense fibrotic tissue known as the stroma, which limits access of most pharmacotherapies to the tumor. Many tumors also have a hostile tumor microenvironment or TME, which suppresses a patient's immune system and makes it less effective in fighting cancer. The combination of a dense stroma and a hostile tumor microenvironment prevents many chemotherapies and immunotherapies from being optimally effective in treating these cancers. This, Coupled with the fact that most anticancer therapies are not efficient in targeting only cancerous tissue defines the major challenge of maximizing effectiveness and safety in the treatment of solid tumors. To combat this, LASATA's approach is to activate the C END rule or Send R system, a naturally occurring Active Transport System to selectively deliver anticancer drugs through the stroma and into the tumor. Speaker 400:09:44LASATA's lead product candidate, LYSTA-one, the recipient of multiple orphan designations, including for pancreatic cancer in both the United States and Europe as well as for malignant glioma in the United States is an investigational drug that actuates the Sendar Active transport mechanism, while also having the potential to modify the tumor microenvironment and make it less immunosuppressive. Lista-one targets tumor vascular endothelial cells as well as tumor cells themselves Based on its affinity for alpha V, beta-three and beta-five integrands that are selectively up regulated on these cells In comparison to healthy tissue, Lista-one is a 9 amino acids cyclic internalizing RGD peptide that once bound to these integrins is cleaved by proteases expressed in the tumor microenvironment to release a linear peptide fragment called a Send R fragment. The Send R fragment has high affinity for and then binds to an adjacent receptor called neuropilin 1 also up regulated on tumor, vascular endothelial cells and tumor cells. To activate the CN rule active transport pathway and ferry anti cancer drugs more efficiently into solid tumors. Additionally, LIST-one has been shown in a range of preclinical models to modify the tumor microenvironment, making it less hostile to immune cells, reducing tumor resistance to anticancer medications and impeding and or preventing the metastatic cascade. Speaker 400:11:32These results come internally from LASATA and from collaborators and research groups around the world and have been the subject of over 300 related scientific publications. Along with our collaborators, We also have amassed significant non clinical data demonstrating enhanced delivery of a range of emerging anticancer therapies, including immunotherapies and RNA based therapeutics. To date, Lista-one has demonstrated favorable safety, Tolerability and activity to enhance delivery of standard of care chemotherapy for patients with metastatic pancreatic cancer. Our development programs are designed to exploit the potential of LISTEN-one to enhance a variety of anticancer treatment modalities in a range of solid tumors. Currently, Lista-one is the subject of about a dozen planned or active clinical trials globally for the treatment of various solid tumors. Speaker 400:12:34Let me touch on a few of these individually. The ASCEND trial is a 155 patient, double blind, randomized, placebo controlled clinical trial evaluating LISTA-one In combination with gemcitabine and nab paclitaxel in patients with metastatic pancreatic ductal adenocarcinoma, also known as m PDAC. The trial is being conducted at up to 40 sites in Australia and New Zealand led by the Australasian Gastrointestinal Clinical Trials Group or AGITG, in collaboration with the NH MRC Clinical Trial Center at the University of Sydney. As previously reported in September, A positive outcome from the planned interim futility analysis was announced by the study's independent data safety monitoring committee, which recommended continuation of the study without modification. In addition, we are excited to report That full enrollment in Cohort A of ASCEND has been achieved and that overall enrollment in the study is now approximately 95% complete. Speaker 400:13:47With that, we now project to have top line data from Cohort A as early as the Q4 of next year, a full year earlier than originally anticipated. We plan to use the results of the ASCEND trial to explore possible conditional approvals in several jurisdictions and to design an optimized Phase 3 program in MPDAC. The BOLSTER trial is a Phase 2a, double blind, placebo controlled, multicenter, Randomized basket trial with investigational sites planned in the United States, Europe, Canada and Asia, Evaluating Lista-one in combination with standards of care in advanced solid tumors, including head and neck, Esophageal and cholangiocarcinoma. This trial will include both cytotoxic and immunotherapy standards of care. As previously announced, patients have now been treated in the head and neck squamous cell carcinoma and cholangiocarcinoma cohorts And we expect a first patient in the esophageal cancer cohort by early next year. Speaker 400:15:00Sendafox, the Phase 1b2a open label trial in the United States evaluating LIST-one In combination with neoadjuvantfulfuronox based therapies in pancreatic, colon and appendiceal cancers Continues to make steady progress with approximately 80% of the overall target number of subjects in the study enrolled. We expect enrollment completion of the pancreatic cohort during the Q4 of this year and completion of the remaining 2 cohorts over the next two quarters with data readout in pancreatic cancer in late 2024. This trial will provide us with pre and post treatment biopsy immuno profiling data as well as long term outcome data. LIST-one is also being evaluated in combination with gemcitabine and nab paclitaxel in a Phase 1b2a Open label trial in China led by our licensee in that territory, Qilu Pharmaceutical. During the 2023 ASCO Annual Meeting, Chelo Pharmaceutical presented an abstract sharing preliminary data from the study, which corroborated previously reported findings from the Phase IbIIa trial of LISTEN-one plus gemcitabine and nab paclitaxel conducted in Australia in patients with metastatic Pancreatic ductal adenocarcinoma. Speaker 400:16:23Final data are expected by the end of the Q2 of 2024. In collaboration with our funding partner WARP-nine, the ILYSTA trial is a Phase IbIIa Randomized single blind, single center safety and pharmacodynamic study in Australia, evaluating LIST-one in combination with the checkpoint inhibitor durvalumab Plus standard of care chemotherapy, nab paclitaxel and gemcitabine versus standard of care alone in patients with locally advanced Nonresectable pancreatic ductal adenocarcinoma. Enrollment completion is expected during 2024. IGOLISTA, a Phase 1b2a proof of concept safety and early efficacy study evaluating LISTEN-one In combination with nivolumab and filferonox as a first line treatment in locally advanced nonresectable Gastroesophageal adenocarcinoma is still pending initiation as a function of availability of funding by our partner WARP9. We hope to have further update on timing related to the execution of the study in coming quarters. Speaker 400:17:36We are also poised to initiate the study of LISTEN-one in combination with temozolomide in glioblastoma multiform or GBM. This study is designed as a Phase 2a double blind placebo controlled randomized proof of concept study evaluating Lista-one When added to standard of care temozolomide versus temozolomide and matching LIST-one placebo in subjects with newly diagnosed glioblastoma multiforme. It will be conducted across multiple sites in Estonia and Latvia and is targeted to enroll 30 patients with a randomization of 2 to 1, ListaOne plus standard of care versus placebo plus standard of care. We are pleased to report that the EU clinical trial application has been approved and we expect the first patient treated before the end of this calendar year. Importantly, as recently announced, Lista-one has been granted orphan designation by the U. Speaker 400:18:36S. Food and Drug Administration for malignant glioma. This action by the FDA not only highlights the unmet medical need, but also recognizes the potential of Lista-one to benefit patients in this indication. Lastly, we also plan to initiate a study of Lista-one in combination with hyperthermal Intraperitoneal chemotherapy, more commonly referred to as HIPEC, intraoperative intraperitoneal lavage In peritoneal carcinomatosis, a cancer that develops as a result of contiguous spread of primary cancers such as ovarian, colorectal and appendiceal along the peritoneum. The study will be a Phase 1 single center unblinded Randomized controlled trial to determine the safety and tolerability of Lista-one administered intraperitoneally in patients with peritoneal metastases from colorectal, appendiceal or ovarian cancer undergoing cytoreductive surgery and HIPEC. Speaker 400:19:4021 total participants will be randomized 2 to 1 to receive Lista-one with HIPEC versus HIPEC alone after cytoreductive surgery. We anticipate the first patient will be treated in the Q4 of 2023. For those who are interested, a more complete description of each of our trials is available in the appendix section of the corporate presentation on our website. Additionally, in the body of the presentation, there are 2 milestone slides that depict the anticipated timing of key execution milestones and data readouts from our trials. With that, I will now turn the call back to Dave. Speaker 200:20:19Thank you, Kristen. In the last 3 9 months of 2023, we have made notable progress on several fronts, including the broad application of LIST-one in combination with a variety of anticancer agents for the treatment of a variety of solid tumor types. To maximize impact and confidence in the results, 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. Now with more than 2 years of capital available on our balance sheet, We believe we are well positioned to focus on the execution of our development plans and to achieve our goal of getting meaningful clinical data readouts as soon as possible. And with that, operator, we're ready to take questions. Operator00:21:16Each listener will be permitted to ask one question at a time and we'll return to the queue for any additional questions. Your question comes from the line of Steve Brozak of WBB Securities. Your line is now open. Speaker 500:21:36I actually have one, but a follow-up as well because they're related. You've gone over a lot of Trial descriptions, how would you describe as the meaning the import of what these Designations that you've been describing are to the trialing system. And I've got a follow-up after that, please. Speaker 200:21:58Thanks, Steve. Appreciate the question. So I think actually it's a very pertinent question because in the industry we toss around The nomenclature of orphan drug designation and fast track designation pretty freely and I think most people might have At least a partial understanding, but I think it's worthwhile explaining. So let's start with Fast Track Designation. Fast Track Designation allows the applicant that would be for the given product and given indication To be eligible for accelerated approval consideration and for a more rapid review cycle with the FDA, both of which are extremely beneficial in terms of getting to market faster. Speaker 200:22:43It also allows for More interaction with FDA in a specialized way. And similarly, orphan drug designation, first of all, it points to the fact that the Indication will have less than 200,000 patients in a given year diagnosed with that particular indication. And as a result, it's also eligible for more rapid review cycles, more rapid and Consistent interaction with the agency. Importantly, you're also eligible to receive grants from the Orphan Drug Division of FDA to develop your products because often they're not as commercially lucrative. And finally, you get an End of period of exclusivity in the market. Speaker 200:23:29So that is in addition to patent protection, you have some market exclusivity. So they're actually Quite valuable designations. They're not given out freely. It's not something that you just make an application and you're guaranteed a result, but There's a pretty critical review process and we were very pleased that the FDA and the EU have granted Morphin drug designation for MPDAC to VISTA-one and also for GBM Cleo, it's for us to 1 here in the United States. Speaker 500:24:01Okay. And that actually highlights the next A follow-up and I'll hop back in the queue. Thank you. You've got these designations which are obviously Significant. You've got multiple programs running with quantifiable endpoints. Speaker 500:24:21You've been Pretty much delivering on everything you said you were looking to do. Yet obviously, the market isn't Really viewing or understand this, what are your thoughts around on your market cap and specifically your stock price Given your execution, what do you think it is? And thanks and I'll hop back in Speaker 200:24:45the queue. Well, thanks, Steve. I actually appreciate the opportunity to address that Somewhat forthrightly because it's something that's on everybody's mind. There is a clear inconsistency with the Advanced stage of our clinical programs, the positive data we've generated, our financial position and the fact that we continue to execute according to plan, that The plan is rather comprehensive and a rather low market cap. In fact, anyone can look and see we're trading Roughly, at somewhere between 35% 40% of our cash on hand, which is just irrational. Speaker 200:25:22I think we have a couple of explanations for that. I mean, part of it is that the entire biotech market has suffered considerably since the beginning of the year with high interest rates and Everybody's stock is down, but in our particular case, there are a few unique characteristics that I think are impeding A stock advancement in the short term, but that I think are available to be overcome in the long term. One of those is that We are fortunate to have a large body of our shareholders. By our calculation, in Rough terms, about 2 thirds of our shareholders are long only holders. These are people who have Bought into the company either when it was in its private stages or at the time of our recent merger or in recent Financing, but did so because they believe in the potential of the programs. Speaker 200:26:15And in order to see the programs reach their maximum value, They are not trading the stock. They're ignoring the fluctuations in stock price and in the market. They're treating us much like they would treat investment in a private company and they're sitting back and waiting for the in inverted commas pivotal data to come out of these trials. And so with a very little float that is a very small fraction of our shareholders trading actively on any given day, There's not really an opportunity for a market to be made for our stock. There's not a lot of people who are buying or selling. Speaker 200:26:55And those very few who do, we trade on average 20,000 to 25,000 shares a day out of over 8,000,000 outstanding. It's a very volatile situation. So I think our opinion is that that will change based on 2 things. As we Get to Data, which as those who have looked at our milestone slide will see is going to be occurring throughout 2024 2025 And also as we then are able to announce additional business development deals and ultimately Do another financing, which will allow larger funds to enter the stock because they can't do so on the market because of the low trading volume. I think we'll see that all change. Speaker 200:27:39But like most people right now in the biotech world, the real focus is on Impeccable execution to data, generating as close to unambiguous data as possible And then letting the product for themselves. So that's what we believe is the problem. There's certainly no issue With the fundamentals of our company, the execution or our plan, which has been scrutinized pretty thoroughly by a lot of Potential partners who are also just sitting there waiting for us to show data. Speaker 300:28:14Got it. All right. Speaker 500:28:15Let me hop back in the queue. Thank you for taking the questions. Speaker 300:28:18Thanks, Steve. Operator00:28:19Thank you so much. And your next question comes from the line of Kent Oliver from Brookline Capital Markets. Your line is now open. Speaker 600:28:30Hi. Good afternoon and thank you for taking the question. First question, regards the ASCEND trial and admittedly it may be too early to Provide any insight on this, but the trial has enrolled very consistently and ahead of your original plan. And other than unmet need and potentially a great drug, which we'll just lay out as givens for now, What are your thoughts with regard to why this has worked so well? Is it a function of The populations in Australia, New Zealand being relatively treatment naive and there's less competition for trials or what have you seen going on that It has worked to your benefit here. Speaker 200:29:24Thanks, Kent. Appreciate that. I think we see a couple of factors that are helping the trial enroll very, very rapidly. First of all, it is a randomized and blinded trial, but In this particular trial, the people who received the control arm are still receiving standard of care. So there's no downside to joining this trial. Speaker 200:29:48It's not as if you would be put on a true placebo, and you would not get any treatment, which would obviously be unethical in an oncology trial. I think you've already touched on one of the situations there. There seems to be a large and growing presence of pancreatic cancer in this part of the world. And there are relatively few treatment centers because the population of Australia is Concentrated around the edges of the country, the country is enormous. But as you all know, the interior is referred to the as the Outback Because it's a desert like area and there's really very little populations. Speaker 200:30:27People are concentrated in areas and they go to These larger centers pretty regularly, it's not as if there are many, many centers around the country for them to go. And so the people who are at those centers Have been actively involved in the development of our trial of our drug from the beginning. It was in Australia that the early Phase Ib, Phase 2a Very compellingly positive data were generated and so there's an enthusiasm that I think is moving forward. And the fact that The addition of Lista-one to standard of care doesn't seem to exacerbate the safety side effects The standard of care is another reason why people are very eager to take on this particular trial. So as you pointed out, it's enrolling very rapidly. Speaker 200:31:15Cohort A has been enrolled since May June timeframe and we're about 95% of the way there. So The official projection is we'll be done by Q2 of next year, but I think anybody can do a quick extrapolation and recognize that it's likely to be done very, very much sooner than that. Speaker 600:31:38Right. Thank you. And just looking at your spending guidance Speaker 400:31:44And Speaker 600:31:44the which honestly looks pretty level over the course of the runway period, How sensitive would that be to the ebb and flow of enrollment in your trials? Because you have ASCEND wrapping up sooner than It's probably one of your larger trials at this point. So how should we think about the correlation between those two things from here? Speaker 200:32:11Well, like all trials, spending is correlated to large except for startup at the beginning and close out at the end, The steady state costs are per patient costs. So as you enroll, you incur expense. And then when you stop enrolling, you stop Those types of expenses. So, but we also have to recognize that we have organized these trials, almost all of our trials, but ASCEND specifically To be done, 1st of all, in Australia where the costs generally are lower than they might be in the United States and where we get about 48% Of all R and D dollars spent, we paid it back to us at cash at the end of the year. And also, we are Essentially, co funding this trial, if you will. Speaker 200:33:03I mean, we're providing the maximum amount of funding, but the number of the Standard of care from the hospitals are being funded by those hospitals. So there will be a reduction And expenditure relative to ASCEND once full enrollment is completed, but it may not be of the same magnitude that one might Expect for trial being completely funded by a sponsor here in the United States, but we still should see a reduction in costs associated with that. Speaker 600:33:37Got it. And I'm assuming those rebates would show up as a Contrary to the expense line as opposed to the top coming in on the top line, is that right? Speaker 200:33:46I'll ask our Head of Finance. James, what's the accounting on the rebate? Speaker 300:33:50Yes, that's correct. We do have 4 qualifying research and development activities in Australia. We are eligible to receive refundable tax incentive between 43.5 up to 48.5. So that does largely offset, let's say, half of the expenses for the ASCEND study in Australia. Speaker 200:34:16And is that accounted for as a reduction in expense or as revenue? Speaker 300:34:21That is accounted for as a reduction in expense. So that would be a reduction to the R and D expense. So it's incorporated therein. Speaker 700:34:36Thank you for that. Speaker 200:34:37Thanks, Ken. Operator00:34:39Thank you so much. And your next question comes from the line of Pete Enderlin of Nazz Partners, your line is now open. Speaker 700:34:50My first question is a follow-up of an earlier one about the valuation of the stock and that is Since List of 1 seems to enhance the efficacy of a wide variety of oncology drugs and a Variety of different modalities as well. The question is, have you guys experienced any increase And inbound inquiries from bigger pharmas that are interested in collaborating with you. Speaker 200:35:18Hi, Pete, and thanks for the question. It actually gives me a chance to talk a bit about the business development activities. The simple The answer to your question is yes. And I mentioned earlier, the consummation of a lot of those Your potential deals is going to be based very, very much so on the delivery of the data that will come out over the course I think all of these companies have products that do well by a variety of different definitions, but could clearly do better. And there's the implication so far With the data that's been generated to date, that Listener 1 can allow them all to do better And that should lead us to a number of possibilities for either exclusive or non exclusive deals, Both on the R and D and the commercial side with a lot of players in the oncology world or just simply the ability to market List 1 more broadly and have it utilized more broadly in the market when that time comes. Speaker 200:36:32But yes, we've had Quite a lot of interest shown and I think an expectation that that interest will continue to increase as data is generated. Speaker 700:36:42And if I can qualify that a little bit in terms of drilling down, do you see Different levels of interest depending on the types of cancer or also since there are varying side effects in a lot of these Treatments, does it vary somewhat by the type of modality like chemo, RNA, immunotherapy or whatever? Or is it pretty much across the board? Speaker 200:37:10I would say it's reasonably distributed. The interest is reasonably distributed among people who Are either developing new cytotoxics or already marketing chemotherapeutics or immunotherapeutics. We've even had discussions with Radiopharmaceutical companies, companies that have antisense products, even companies with cellular therapies and nanoparticles. So I think there's a broad level of interest because the mechanism of action of VISTA-one in theory should help All of those better target solid tumors and infiltrate those tumors. So I think Speaker 700:37:48And also reduce side effects, I guess, is an important part of it as well, Because there's Speaker 200:37:53no I don't know if it will reduce side effects. I want to be very careful what we say. That would be wonderful. But what we will say is that This evidence to date shows that LISTEN-one will not increase the side effects of those agents. So you should get better efficacy With the same level of side effects, normally to get better efficacy, you increase concentration and that leads to greater Side effects. Speaker 200:38:15So I think we're going to be able, but I wouldn't say that we eliminate side effects. We're not so far along yet. Speaker 700:38:20Okay. No, thank you. And then just one quick one for Kristen, did you mention the number or the percentage of enrollment so far in the BOLSTER trial? I didn't get it if you did. Speaker 400:38:31No, I did not. The bolster trial recently opened and we're early in enrollment. Speaker 700:38:36Okay. Thanks a lot. I'll get back in the queue. Speaker 600:38:38Thank you. Operator00:38:40Thank you so much. And there are no further questions. This concludes the question and answer session. I will now turn the call back to Doctor. Mazzo for closing remarks. Speaker 200:39:04Well, 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 continuing to provide updates on our achievements and progress. We remain grateful for your continued interest and support. Stay well and have a good evening.Read morePowered by Conference Call Audio Live Call not available Earnings Conference CallLisata Therapeutics Q3 202300:00 / 00:00Speed:1x1.25x1.5x2x Earnings DocumentsSlide DeckPress Release(8-K)Quarterly report(10-Q) Lisata Therapeutics Earnings HeadlinesLisata, Catalent partner for cancer drug researchApril 17 at 3:30 PM | uk.investing.comLisata Therapeutics signs research license with CatalentApril 15 at 9:17 AM | proactiveinvestors.comThe Trump Dump is starting; Get out of stocks now?The first 365 days of the Trump presidency… Will be the best time to get rich in American history.April 18, 2025 | Paradigm Press (Ad)Lisata Therapeutics Announces Research License with CatalentApril 15 at 8:00 AM | globenewswire.comLisata Therapeutics CEO discusses AI drug discovery collaboration - ICYMIMarch 8, 2025 | proactiveinvestors.comLisata Therapeutics And GATC Health Partner To Accelerate Drug Development Using AI TechnologyMarch 7, 2025 | nasdaq.comSee More Lisata Therapeutics Headlines Get Earnings Announcements in your inboxWant to stay updated on the latest earnings announcements and upcoming reports for companies like Lisata Therapeutics? Sign up for Earnings360's daily newsletter to receive timely earnings updates on Lisata Therapeutics and other key companies, straight to your email. Email Address About Lisata TherapeuticsLisata Therapeutics (NASDAQ:LSTA), a clinical-stage pharmaceutical company, focuses on the discovery, development, and commercialization of innovative therapies for the treatment of solid tumors and other diseases. Its product candidates include LSTA1, which is in Phase 2a and 2b clinical studies for the treatment of solid tumor, including metastatic pancreatic ductal adenocarcinoma (mPDAC), in combination with a range of anti-cancer regimens; XOWNA that is in Phase IIa clinical trial for the treatment of coronary microvascular dysfunction; and CD34+ cell therapy for the treatment of chronic kidney disease. 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There are 8 speakers on the call. Operator00:00:00Welcome to the TESARO Therapeutics Third Quarter 2023 Financial Results and Business Update Conference Call. Currently, all participants are in a listen only mode. Following management's prepared remarks, we will hold a Q and A session. As a reminder, this call is being recorded today, Thursday, November 2, 2023. I will now turn the call over to John Menditto, Vice President of Investor Relations and Corporate Communications at Lissata, please go ahead, sir. Speaker 100:00:38Thank you, operator, and good afternoon, everyone. Welcome to LASADA's Q3 2023 conference call to discuss our financial results and the opportunity to provide a business update. Joining me today from our management team are Doctor. David Mazzo, President and Chief Executive Officer Doctor. Kristin Buck, Executive Vice President of Research and Development and Chief Medical Officer and James Nisko, Vice President of Finance and Treasury. Speaker 100:01:04Shortly before this call, we issued a press release announcing our Q3 of the webcast replay of this call. If you have not received this news release or if you'd like to be added to the company's e mail distribution list, Please email me at jmandidolasada.com. 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 LASATA. I encourage you to review the company's filings with the 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 LASATA Therapeutics undertakes no obligation to revise or update any statements to reflect events or circumstances after the date of this conference call. Speaker 100:02:18With that, I will now turn the call over to Doctor. David Mazzo. Dave? Speaker 200:02:24Thank you, John, and good afternoon, everyone. Thank you for joining us today as we provide an overview of recent business highlights, discuss our Q3 2023 financial results and give an update on the progress of our various development programs. The Q3 was another productive quarter for LASATA as we added to the momentum of the first half of 2023 with the initiation and advancement of new clinical development programs targeting a variety of advanced solid tumors using LISTA-one, our lead product candidate in combination with multiple anticancer agents of differing modalities. As we have previously reported, We have both preclinical data and early clinical data in humans that we believe demonstrates the potential of Lista-one to become an integral part of a revised standard of care treatment regimen for many difficult to treat cancers. During this call, our Chief Medical Officer, Doctor. Speaker 200:03:17Kristin Buck, We'll provide an update on our clinical programs following the review of our financial results. And with that, I now will turn the call over to James Mitzko, our Vice President of Finance and Treasury. James? Speaker 300:03:31Thanks, Steve. Good afternoon, all. I'm pleased to join you today to present Summary of our Q3 2023 financial results. Starting with operating expenses. For the 3 months ended September 30, 2023, operating expenses totaled $6,000,000 compared to $37,700,000 for the 3 months ended September 30, 2022, representing a decrease of 84.2%. Speaker 300:04:00Excluding the in process research and development expense of $30,400,000 Related to our merger with Cen Therapeutics in September 2022, operating expenses decreased by $1,400,000 or 18.6% compared to the 3 months ended September 30, 2022. Operating expenses comprised the following. Research and development expenses were approximately $3,400,000 for the 3 months ended September 30, 2023 compared to $3,300,000 for the 3 months ended September 30, 2022, representing an increase of 1.3%. Expenses this The quarter were primarily due to study activities associated with the bolster trial here in the United States, Enrollment activities for the ASCEND study in Australia, start up activities for the glioblastoma multiform study in Europe and general chemistry, manufacturing and control activities for Lista-one to support all development General and administrative expenses were approximately $2,600,000 for the 3 months ended September 30, 2023 compared to $4,000,000 for the 3 months ended September 30, 2022, representing a decrease of 1,400,000 or 35.3%. This was primarily due to non recurring merger related costs in the prior year, A decrease in equity expense due to prior year performance stock unit vesting, merger option assumption expense and departing Board member restricted stock unit vesting and timing of our annual stockholder meeting versus the prior year. Speaker 300:06:08Overall, net losses were $5,300,000 for the 3 months ended September 30, 2023 compared to $37,400,000 for the 3 months ended September 30, 2022. Excluding the in process research and development expense of $30,400,000 related to our merger with CEN Therapeutics In September 22, net losses for the 3 months ended September 30, 2023 decreased by $1,700,000 or 24.7 percent compared to the 3 months ended September 30, 2022. Turning now to our balance sheet and cash flow. As of September 30, 2023, The company had cash, cash equivalents and marketable securities of approximately 54,400,000 The company remains confident that its projected capital will fund its current and proposed operations into early 2026, encompassing anticipated data milestones from all its ongoing and planned clinical trials. This completes my financial overview, And I will now turn the call over to our Chief Medical Officer, Doctor. Speaker 300:07:30Kristin Buck, for the review of our clinical development pipeline. Kristin? Speaker 400:07:37Thank you, James, and good afternoon, everyone. As those who have been following us know, LASATA's pipeline is built on a Portfolio of proprietary and patented technology that is grounded in strong scientific rationale and the body of published preclinical and early clinical data. Our platform technology is designed to address major impediments to the successful treatment of advanced solid tumors In an environment of increasing pharmacoeconomic pressures, generating meaningful clinical data is critically important in this field 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 an overview of List for the treatment of advanced solid tumors in combination with other anticancer agents. Despite advances in cancer therapy today, Many solid tumors remain difficult to treat effectively. Speaker 400:08:35Cancers such as pancreatic cancer, gastric cancers and other solid tumors are surrounded by a dense fibrotic tissue known as the stroma, which limits access of most pharmacotherapies to the tumor. Many tumors also have a hostile tumor microenvironment or TME, which suppresses a patient's immune system and makes it less effective in fighting cancer. The combination of a dense stroma and a hostile tumor microenvironment prevents many chemotherapies and immunotherapies from being optimally effective in treating these cancers. This, Coupled with the fact that most anticancer therapies are not efficient in targeting only cancerous tissue defines the major challenge of maximizing effectiveness and safety in the treatment of solid tumors. To combat this, LASATA's approach is to activate the C END rule or Send R system, a naturally occurring Active Transport System to selectively deliver anticancer drugs through the stroma and into the tumor. Speaker 400:09:44LASATA's lead product candidate, LYSTA-one, the recipient of multiple orphan designations, including for pancreatic cancer in both the United States and Europe as well as for malignant glioma in the United States is an investigational drug that actuates the Sendar Active transport mechanism, while also having the potential to modify the tumor microenvironment and make it less immunosuppressive. Lista-one targets tumor vascular endothelial cells as well as tumor cells themselves Based on its affinity for alpha V, beta-three and beta-five integrands that are selectively up regulated on these cells In comparison to healthy tissue, Lista-one is a 9 amino acids cyclic internalizing RGD peptide that once bound to these integrins is cleaved by proteases expressed in the tumor microenvironment to release a linear peptide fragment called a Send R fragment. The Send R fragment has high affinity for and then binds to an adjacent receptor called neuropilin 1 also up regulated on tumor, vascular endothelial cells and tumor cells. To activate the CN rule active transport pathway and ferry anti cancer drugs more efficiently into solid tumors. Additionally, LIST-one has been shown in a range of preclinical models to modify the tumor microenvironment, making it less hostile to immune cells, reducing tumor resistance to anticancer medications and impeding and or preventing the metastatic cascade. Speaker 400:11:32These results come internally from LASATA and from collaborators and research groups around the world and have been the subject of over 300 related scientific publications. Along with our collaborators, We also have amassed significant non clinical data demonstrating enhanced delivery of a range of emerging anticancer therapies, including immunotherapies and RNA based therapeutics. To date, Lista-one has demonstrated favorable safety, Tolerability and activity to enhance delivery of standard of care chemotherapy for patients with metastatic pancreatic cancer. Our development programs are designed to exploit the potential of LISTEN-one to enhance a variety of anticancer treatment modalities in a range of solid tumors. Currently, Lista-one is the subject of about a dozen planned or active clinical trials globally for the treatment of various solid tumors. Speaker 400:12:34Let me touch on a few of these individually. The ASCEND trial is a 155 patient, double blind, randomized, placebo controlled clinical trial evaluating LISTA-one In combination with gemcitabine and nab paclitaxel in patients with metastatic pancreatic ductal adenocarcinoma, also known as m PDAC. The trial is being conducted at up to 40 sites in Australia and New Zealand led by the Australasian Gastrointestinal Clinical Trials Group or AGITG, in collaboration with the NH MRC Clinical Trial Center at the University of Sydney. As previously reported in September, A positive outcome from the planned interim futility analysis was announced by the study's independent data safety monitoring committee, which recommended continuation of the study without modification. In addition, we are excited to report That full enrollment in Cohort A of ASCEND has been achieved and that overall enrollment in the study is now approximately 95% complete. Speaker 400:13:47With that, we now project to have top line data from Cohort A as early as the Q4 of next year, a full year earlier than originally anticipated. We plan to use the results of the ASCEND trial to explore possible conditional approvals in several jurisdictions and to design an optimized Phase 3 program in MPDAC. The BOLSTER trial is a Phase 2a, double blind, placebo controlled, multicenter, Randomized basket trial with investigational sites planned in the United States, Europe, Canada and Asia, Evaluating Lista-one in combination with standards of care in advanced solid tumors, including head and neck, Esophageal and cholangiocarcinoma. This trial will include both cytotoxic and immunotherapy standards of care. As previously announced, patients have now been treated in the head and neck squamous cell carcinoma and cholangiocarcinoma cohorts And we expect a first patient in the esophageal cancer cohort by early next year. Speaker 400:15:00Sendafox, the Phase 1b2a open label trial in the United States evaluating LIST-one In combination with neoadjuvantfulfuronox based therapies in pancreatic, colon and appendiceal cancers Continues to make steady progress with approximately 80% of the overall target number of subjects in the study enrolled. We expect enrollment completion of the pancreatic cohort during the Q4 of this year and completion of the remaining 2 cohorts over the next two quarters with data readout in pancreatic cancer in late 2024. This trial will provide us with pre and post treatment biopsy immuno profiling data as well as long term outcome data. LIST-one is also being evaluated in combination with gemcitabine and nab paclitaxel in a Phase 1b2a Open label trial in China led by our licensee in that territory, Qilu Pharmaceutical. During the 2023 ASCO Annual Meeting, Chelo Pharmaceutical presented an abstract sharing preliminary data from the study, which corroborated previously reported findings from the Phase IbIIa trial of LISTEN-one plus gemcitabine and nab paclitaxel conducted in Australia in patients with metastatic Pancreatic ductal adenocarcinoma. Speaker 400:16:23Final data are expected by the end of the Q2 of 2024. In collaboration with our funding partner WARP-nine, the ILYSTA trial is a Phase IbIIa Randomized single blind, single center safety and pharmacodynamic study in Australia, evaluating LIST-one in combination with the checkpoint inhibitor durvalumab Plus standard of care chemotherapy, nab paclitaxel and gemcitabine versus standard of care alone in patients with locally advanced Nonresectable pancreatic ductal adenocarcinoma. Enrollment completion is expected during 2024. IGOLISTA, a Phase 1b2a proof of concept safety and early efficacy study evaluating LISTEN-one In combination with nivolumab and filferonox as a first line treatment in locally advanced nonresectable Gastroesophageal adenocarcinoma is still pending initiation as a function of availability of funding by our partner WARP9. We hope to have further update on timing related to the execution of the study in coming quarters. Speaker 400:17:36We are also poised to initiate the study of LISTEN-one in combination with temozolomide in glioblastoma multiform or GBM. This study is designed as a Phase 2a double blind placebo controlled randomized proof of concept study evaluating Lista-one When added to standard of care temozolomide versus temozolomide and matching LIST-one placebo in subjects with newly diagnosed glioblastoma multiforme. It will be conducted across multiple sites in Estonia and Latvia and is targeted to enroll 30 patients with a randomization of 2 to 1, ListaOne plus standard of care versus placebo plus standard of care. We are pleased to report that the EU clinical trial application has been approved and we expect the first patient treated before the end of this calendar year. Importantly, as recently announced, Lista-one has been granted orphan designation by the U. Speaker 400:18:36S. Food and Drug Administration for malignant glioma. This action by the FDA not only highlights the unmet medical need, but also recognizes the potential of Lista-one to benefit patients in this indication. Lastly, we also plan to initiate a study of Lista-one in combination with hyperthermal Intraperitoneal chemotherapy, more commonly referred to as HIPEC, intraoperative intraperitoneal lavage In peritoneal carcinomatosis, a cancer that develops as a result of contiguous spread of primary cancers such as ovarian, colorectal and appendiceal along the peritoneum. The study will be a Phase 1 single center unblinded Randomized controlled trial to determine the safety and tolerability of Lista-one administered intraperitoneally in patients with peritoneal metastases from colorectal, appendiceal or ovarian cancer undergoing cytoreductive surgery and HIPEC. Speaker 400:19:4021 total participants will be randomized 2 to 1 to receive Lista-one with HIPEC versus HIPEC alone after cytoreductive surgery. We anticipate the first patient will be treated in the Q4 of 2023. For those who are interested, a more complete description of each of our trials is available in the appendix section of the corporate presentation on our website. Additionally, in the body of the presentation, there are 2 milestone slides that depict the anticipated timing of key execution milestones and data readouts from our trials. With that, I will now turn the call back to Dave. Speaker 200:20:19Thank you, Kristen. In the last 3 9 months of 2023, we have made notable progress on several fronts, including the broad application of LIST-one in combination with a variety of anticancer agents for the treatment of a variety of solid tumor types. To maximize impact and confidence in the results, 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. Now with more than 2 years of capital available on our balance sheet, We believe we are well positioned to focus on the execution of our development plans and to achieve our goal of getting meaningful clinical data readouts as soon as possible. And with that, operator, we're ready to take questions. Operator00:21:16Each listener will be permitted to ask one question at a time and we'll return to the queue for any additional questions. Your question comes from the line of Steve Brozak of WBB Securities. Your line is now open. Speaker 500:21:36I actually have one, but a follow-up as well because they're related. You've gone over a lot of Trial descriptions, how would you describe as the meaning the import of what these Designations that you've been describing are to the trialing system. And I've got a follow-up after that, please. Speaker 200:21:58Thanks, Steve. Appreciate the question. So I think actually it's a very pertinent question because in the industry we toss around The nomenclature of orphan drug designation and fast track designation pretty freely and I think most people might have At least a partial understanding, but I think it's worthwhile explaining. So let's start with Fast Track Designation. Fast Track Designation allows the applicant that would be for the given product and given indication To be eligible for accelerated approval consideration and for a more rapid review cycle with the FDA, both of which are extremely beneficial in terms of getting to market faster. Speaker 200:22:43It also allows for More interaction with FDA in a specialized way. And similarly, orphan drug designation, first of all, it points to the fact that the Indication will have less than 200,000 patients in a given year diagnosed with that particular indication. And as a result, it's also eligible for more rapid review cycles, more rapid and Consistent interaction with the agency. Importantly, you're also eligible to receive grants from the Orphan Drug Division of FDA to develop your products because often they're not as commercially lucrative. And finally, you get an End of period of exclusivity in the market. Speaker 200:23:29So that is in addition to patent protection, you have some market exclusivity. So they're actually Quite valuable designations. They're not given out freely. It's not something that you just make an application and you're guaranteed a result, but There's a pretty critical review process and we were very pleased that the FDA and the EU have granted Morphin drug designation for MPDAC to VISTA-one and also for GBM Cleo, it's for us to 1 here in the United States. Speaker 500:24:01Okay. And that actually highlights the next A follow-up and I'll hop back in the queue. Thank you. You've got these designations which are obviously Significant. You've got multiple programs running with quantifiable endpoints. Speaker 500:24:21You've been Pretty much delivering on everything you said you were looking to do. Yet obviously, the market isn't Really viewing or understand this, what are your thoughts around on your market cap and specifically your stock price Given your execution, what do you think it is? And thanks and I'll hop back in Speaker 200:24:45the queue. Well, thanks, Steve. I actually appreciate the opportunity to address that Somewhat forthrightly because it's something that's on everybody's mind. There is a clear inconsistency with the Advanced stage of our clinical programs, the positive data we've generated, our financial position and the fact that we continue to execute according to plan, that The plan is rather comprehensive and a rather low market cap. In fact, anyone can look and see we're trading Roughly, at somewhere between 35% 40% of our cash on hand, which is just irrational. Speaker 200:25:22I think we have a couple of explanations for that. I mean, part of it is that the entire biotech market has suffered considerably since the beginning of the year with high interest rates and Everybody's stock is down, but in our particular case, there are a few unique characteristics that I think are impeding A stock advancement in the short term, but that I think are available to be overcome in the long term. One of those is that We are fortunate to have a large body of our shareholders. By our calculation, in Rough terms, about 2 thirds of our shareholders are long only holders. These are people who have Bought into the company either when it was in its private stages or at the time of our recent merger or in recent Financing, but did so because they believe in the potential of the programs. Speaker 200:26:15And in order to see the programs reach their maximum value, They are not trading the stock. They're ignoring the fluctuations in stock price and in the market. They're treating us much like they would treat investment in a private company and they're sitting back and waiting for the in inverted commas pivotal data to come out of these trials. And so with a very little float that is a very small fraction of our shareholders trading actively on any given day, There's not really an opportunity for a market to be made for our stock. There's not a lot of people who are buying or selling. Speaker 200:26:55And those very few who do, we trade on average 20,000 to 25,000 shares a day out of over 8,000,000 outstanding. It's a very volatile situation. So I think our opinion is that that will change based on 2 things. As we Get to Data, which as those who have looked at our milestone slide will see is going to be occurring throughout 2024 2025 And also as we then are able to announce additional business development deals and ultimately Do another financing, which will allow larger funds to enter the stock because they can't do so on the market because of the low trading volume. I think we'll see that all change. Speaker 200:27:39But like most people right now in the biotech world, the real focus is on Impeccable execution to data, generating as close to unambiguous data as possible And then letting the product for themselves. So that's what we believe is the problem. There's certainly no issue With the fundamentals of our company, the execution or our plan, which has been scrutinized pretty thoroughly by a lot of Potential partners who are also just sitting there waiting for us to show data. Speaker 300:28:14Got it. All right. Speaker 500:28:15Let me hop back in the queue. Thank you for taking the questions. Speaker 300:28:18Thanks, Steve. Operator00:28:19Thank you so much. And your next question comes from the line of Kent Oliver from Brookline Capital Markets. Your line is now open. Speaker 600:28:30Hi. Good afternoon and thank you for taking the question. First question, regards the ASCEND trial and admittedly it may be too early to Provide any insight on this, but the trial has enrolled very consistently and ahead of your original plan. And other than unmet need and potentially a great drug, which we'll just lay out as givens for now, What are your thoughts with regard to why this has worked so well? Is it a function of The populations in Australia, New Zealand being relatively treatment naive and there's less competition for trials or what have you seen going on that It has worked to your benefit here. Speaker 200:29:24Thanks, Kent. Appreciate that. I think we see a couple of factors that are helping the trial enroll very, very rapidly. First of all, it is a randomized and blinded trial, but In this particular trial, the people who received the control arm are still receiving standard of care. So there's no downside to joining this trial. Speaker 200:29:48It's not as if you would be put on a true placebo, and you would not get any treatment, which would obviously be unethical in an oncology trial. I think you've already touched on one of the situations there. There seems to be a large and growing presence of pancreatic cancer in this part of the world. And there are relatively few treatment centers because the population of Australia is Concentrated around the edges of the country, the country is enormous. But as you all know, the interior is referred to the as the Outback Because it's a desert like area and there's really very little populations. Speaker 200:30:27People are concentrated in areas and they go to These larger centers pretty regularly, it's not as if there are many, many centers around the country for them to go. And so the people who are at those centers Have been actively involved in the development of our trial of our drug from the beginning. It was in Australia that the early Phase Ib, Phase 2a Very compellingly positive data were generated and so there's an enthusiasm that I think is moving forward. And the fact that The addition of Lista-one to standard of care doesn't seem to exacerbate the safety side effects The standard of care is another reason why people are very eager to take on this particular trial. So as you pointed out, it's enrolling very rapidly. Speaker 200:31:15Cohort A has been enrolled since May June timeframe and we're about 95% of the way there. So The official projection is we'll be done by Q2 of next year, but I think anybody can do a quick extrapolation and recognize that it's likely to be done very, very much sooner than that. Speaker 600:31:38Right. Thank you. And just looking at your spending guidance Speaker 400:31:44And Speaker 600:31:44the which honestly looks pretty level over the course of the runway period, How sensitive would that be to the ebb and flow of enrollment in your trials? Because you have ASCEND wrapping up sooner than It's probably one of your larger trials at this point. So how should we think about the correlation between those two things from here? Speaker 200:32:11Well, like all trials, spending is correlated to large except for startup at the beginning and close out at the end, The steady state costs are per patient costs. So as you enroll, you incur expense. And then when you stop enrolling, you stop Those types of expenses. So, but we also have to recognize that we have organized these trials, almost all of our trials, but ASCEND specifically To be done, 1st of all, in Australia where the costs generally are lower than they might be in the United States and where we get about 48% Of all R and D dollars spent, we paid it back to us at cash at the end of the year. And also, we are Essentially, co funding this trial, if you will. Speaker 200:33:03I mean, we're providing the maximum amount of funding, but the number of the Standard of care from the hospitals are being funded by those hospitals. So there will be a reduction And expenditure relative to ASCEND once full enrollment is completed, but it may not be of the same magnitude that one might Expect for trial being completely funded by a sponsor here in the United States, but we still should see a reduction in costs associated with that. Speaker 600:33:37Got it. And I'm assuming those rebates would show up as a Contrary to the expense line as opposed to the top coming in on the top line, is that right? Speaker 200:33:46I'll ask our Head of Finance. James, what's the accounting on the rebate? Speaker 300:33:50Yes, that's correct. We do have 4 qualifying research and development activities in Australia. We are eligible to receive refundable tax incentive between 43.5 up to 48.5. So that does largely offset, let's say, half of the expenses for the ASCEND study in Australia. Speaker 200:34:16And is that accounted for as a reduction in expense or as revenue? Speaker 300:34:21That is accounted for as a reduction in expense. So that would be a reduction to the R and D expense. So it's incorporated therein. Speaker 700:34:36Thank you for that. Speaker 200:34:37Thanks, Ken. Operator00:34:39Thank you so much. And your next question comes from the line of Pete Enderlin of Nazz Partners, your line is now open. Speaker 700:34:50My first question is a follow-up of an earlier one about the valuation of the stock and that is Since List of 1 seems to enhance the efficacy of a wide variety of oncology drugs and a Variety of different modalities as well. The question is, have you guys experienced any increase And inbound inquiries from bigger pharmas that are interested in collaborating with you. Speaker 200:35:18Hi, Pete, and thanks for the question. It actually gives me a chance to talk a bit about the business development activities. The simple The answer to your question is yes. And I mentioned earlier, the consummation of a lot of those Your potential deals is going to be based very, very much so on the delivery of the data that will come out over the course I think all of these companies have products that do well by a variety of different definitions, but could clearly do better. And there's the implication so far With the data that's been generated to date, that Listener 1 can allow them all to do better And that should lead us to a number of possibilities for either exclusive or non exclusive deals, Both on the R and D and the commercial side with a lot of players in the oncology world or just simply the ability to market List 1 more broadly and have it utilized more broadly in the market when that time comes. Speaker 200:36:32But yes, we've had Quite a lot of interest shown and I think an expectation that that interest will continue to increase as data is generated. Speaker 700:36:42And if I can qualify that a little bit in terms of drilling down, do you see Different levels of interest depending on the types of cancer or also since there are varying side effects in a lot of these Treatments, does it vary somewhat by the type of modality like chemo, RNA, immunotherapy or whatever? Or is it pretty much across the board? Speaker 200:37:10I would say it's reasonably distributed. The interest is reasonably distributed among people who Are either developing new cytotoxics or already marketing chemotherapeutics or immunotherapeutics. We've even had discussions with Radiopharmaceutical companies, companies that have antisense products, even companies with cellular therapies and nanoparticles. So I think there's a broad level of interest because the mechanism of action of VISTA-one in theory should help All of those better target solid tumors and infiltrate those tumors. So I think Speaker 700:37:48And also reduce side effects, I guess, is an important part of it as well, Because there's Speaker 200:37:53no I don't know if it will reduce side effects. I want to be very careful what we say. That would be wonderful. But what we will say is that This evidence to date shows that LISTEN-one will not increase the side effects of those agents. So you should get better efficacy With the same level of side effects, normally to get better efficacy, you increase concentration and that leads to greater Side effects. Speaker 200:38:15So I think we're going to be able, but I wouldn't say that we eliminate side effects. We're not so far along yet. Speaker 700:38:20Okay. No, thank you. And then just one quick one for Kristen, did you mention the number or the percentage of enrollment so far in the BOLSTER trial? I didn't get it if you did. Speaker 400:38:31No, I did not. The bolster trial recently opened and we're early in enrollment. Speaker 700:38:36Okay. Thanks a lot. I'll get back in the queue. Speaker 600:38:38Thank you. Operator00:38:40Thank you so much. And there are no further questions. This concludes the question and answer session. I will now turn the call back to Doctor. Mazzo for closing remarks. Speaker 200:39:04Well, 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 continuing to provide updates on our achievements and progress. We remain grateful for your continued interest and support. Stay well and have a good evening.Read morePowered by