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spk00: Please stand by. Your program is about to begin. If you need audio assistance during today's program, please press star zero. Good afternoon, ladies and gentlemen. Welcome to the PLUS Therapeutics first quarter 2022 results call. At this time, all participants have been placed in a listen-only mode, and the floor will be open for your questions following the presentation. If you would like to ask a question at that time, please press star one on your touch-tone telephone keypad. If at any point your question has been answered, you may remove yourself from the queue by pressing the pound key. We ask that you please pick up your handset to allow optimal sound quality. If you should require operator assistance, please press star zero. Before we begin, we want to advise you that over the course of the call and question and answer session, forward-looking statements will be made regarding events, trends, business prospects, and financial performance, which may affect Plus Therapeutics' future operating results and financial position. All such statements are subject to risk and uncertainties, including the risk and uncertainties described under the risk factors section included in Plus Therapeutics' annual reports on Form 10-K and quarterly reports on Form 10-Q filed with the Securities and Exchange Commission from time to time. Plus Therapeutics advises you to review these risk factors in considering such statements. Plus Therapeutics assumes no responsibility to update or revise any forward-looking statements to reflect events, trends, or circumstances after the date they are made. It is now my pleasure to turn the floor over to Dr. Mark Hedrick, Plus Therapeutics President and Chief Executive Officer. Sir, you may begin.
spk01: Thank you very much, Gretchen. Good afternoon, everyone. Thank you once again for taking the time to join us today as we provide an overview of recent business highlights and discuss our 2022 first quarter financial results. Joining me on the call today is Dr. Norman LaFrance, our Chief Medical Officer, and Andrew Sims, our Chief Financial Officer. I'll begin the call by reviewing our recent corporate and clinical progress before turning the call over to Norman who will provide commentary on our clinical progress for 2022. And then following, Norm and Andrew will review our financials. Despite the short interval since we last reported quarterly results, I continue to be very pleased with our overall progress as we work towards several meaningful catalysts and milestones throughout 2022. During the first quarter, we began enrolling patients in our Respect LM trial of 186 RNL in patients with leptomeningeal metastases, or LM. The trial is a multicenter 1-2A dose escalation study to determine the MTD, maximum tolerated dose, and MFD, and safety and efficacy of RNL 186 in LM. LM is a typically fatal complication associated with advanced cancers that affect the fluid line structures of the central nervous system, or leptomeninges. Median survival with current aggressive treatment is about three to eight and a half months, depending on which primary tumor caused the LM.
spk02: And the one and two- Survival without treatment is only a few weeks.
spk01: LM is diagnosed in approximately 5% of cancers, 20% of patients at autopsy. U.S. annual incidence is about 110,000 patients and growing, and the prevalence of neurologic impairment in these patients is about 50%. Most common tumors giving rise to LM are breast cancer, lung cancer, melanoma, and gastrointestinal malignancies. There are no FDA-approved therapies. And standard treatment that is employed includes external beam radiation therapy to the affected sites, followed by chemotherapy given either orally or intravenously or even directly into the cerebral spinal fluid. Although we can only draw limited conclusions from our initial experience, we're very pleased with the outcome in the first patient receiving a single administration of 186 RNL. Specifically, we found that the drug circulated rapidly throughout the cerebrospinal fluid space. We found that radiation was released to the leptomeninges and CSF for at least one week after treatment. The patient exhibited no adverse events, and 186-RNL reduced the circulating tumor cell counts by over 90% at two weeks after treatment. This is really about as good as it gets in a first-in-man, first patient in a phase one trial. So we're very excited about this very preliminary result.
spk02: We now have two out of six sites being onboarded as we speak.
spk01: We're on track to have at least the first two cohorts completed by the end of 2022, and hopefully a bit more than that. As to our ongoing clinical development program for 186-RNL and recurrent glioblastoma, we have a number of updates. First, as a reminder, that trial is a dual phase 1 to a multicenter sequential cohort open-label volume and dose escalation study for recurrent glioblastoma or GBM. The trial is currently funded to a significant degree, as many of you may know, by the U.S. National Institutes of Health and the NCI. Glioblastoma affects about 13,000 patients annually in the US and about the same number of patients in the EU. It's the most common and lethal form of brain cancer and treatment of this devastating disease remains a very significant unmet medical challenge. In terms of the clinical data, Twenty-three patients have been treated, and 186-RNL appears to be safe and well-tolerated, and this data, presented most recently back in March, can be found in detail on our website, and that's accessible to anyone. In summary, no dose-limiting toxicities have been observed. Generally, mild to moderate AEs have been seen, and seven SAEs, all grade three or lower, and most are not deemed to be RNL-related. In terms of drug delivery, we are now reliably able to deliver over 100 gray of absorbed radiation dose to tumors, which is our empirically determined minimal dose threshold of adequate absorbed radiation. And we can get well over 80%, and we think 90% is achievable in terms of reliable dose delivery of 100 gray. Finally, we have observed both the median and median overall survival signal that exceeds the best published rate for monotherapy . Based on this data, I'd like to just explain our big picture plan. We plan to bifurcate the current GBM clinical development plan based on tumor size. So, for tumors of approximately 15 to 20 cc's in volume, which represents about one-half to about two-thirds of all recurrent glioblastomas, we plan to use the cohort six dose of 22.3 millicuries and 8.8 cc's of volume as our recommended first phase two registrational dose. For tumors of larger size, potentially requiring greater radiation dosages, and treatment volumes, we intend to continue our Phase I-II dose escalation trial to establish the upper limits of dose and potential for DLTs, or dose-limiting toxicities. In 2022, for GVM, we have two key regulatory milestones. We have already, in 2022, submitted and asked for the first of two FDA meetings specifically a Type C CMC meeting to determine the sufficiency of our CMC package for GMP-186-RNL to support a registrational trial. And then, relatedly to the CMC development, our team continues to make excellent progress in our drug scale-up and manufacturing activities. Specifically, the company has finalized key RNL drug development and characterization activities for GMP manufacturing to support our planned Phase II Registrational Trial and commercialization activities thereafter. The company remains on track to deliver GMP RNL by mid-2022. The second FDA meeting is a clinically focused meeting planned for Q2-Q3 to solicit FDA feedback on our planned Phase II Registrational Trial using our recommended Phase II dose, as mentioned, 22.3 millicuries and a little less than 9 cc of volume. Also during Q1, we completed another key milestone. Specifically, we successfully completed the preliminary evaluation phase and entered into a broad partnership with Metadata to use its synthetic control arm platform in real-world data as the comparators for our glioblastoma trials. The primary goal of this partnership is to develop an FDA-compliant control group of patients identical to the patients thus far treated in our Phase 1-2A trial and in the planned Phase 2 Registrational Trial. That data will be used to support our planned end-of-phase meeting with the FDA and proposed Phase 2 Registrational Trial. More generally, Synthetic control arm or SCA platform facilitates the use of historical clinical trial data in a manner that has been favorably received by the FDA. These FDAs reduce the time and costs associated with complex clinical trials in rare diseases such as glioblastoma, allowing for fewer patients to be exposed to placebos or existing standard of care treatments that might not be effective for them. It offers them greater access to potentially life-extending therapies. And although a recent advancement, the FDA has already agreed to recognize a Phase III clinical design incorporating an SCA in a registrational randomized control arm for recurrent glioblastoma. Besides initiating our Phase II registrational trial with RNL in recurrent GBM, as I mentioned above, We also continued enrollment in our Phase I-II-A dose escalation GBM trial, and that will continue. Finally, this quarter, we intend to open a Phase II multi-dosing extension trial of RNL in recurrent glioblastoma. As you know if you follow the company, glioblastoma is notoriously difficult to cure, and recurrent disease is the norm. This extension trial will give us important information about the utility of multiple potential doses of 186-RNL in the overall treatment paradigm for these patients. The goal of the trial is to determine the safety, feasibility, and potential efficacy of using additional doses of RNL in patients following the initial single administration of RNL as we have done previously in the Phase 1-2A trial. This is really important to our big dream of one day, if not curing GBM, then turning it into a chronic disease in which we help patients live with brain cancer. Finally, in Q1, we announced our license of a novel radioembolic microparticle technology from the University of Texas. As we've said many times, we believe the future of cancer therapy is precise targeting of tumors with the most potent cancer-killing agents while minimizing damage to normal tissues. This transaction builds upon our existing rhenium nanoliposome technology. And with this new technology, we can, with a resorbable biomaterial, embolic technology, coupled with a highly potent radiotherapeutic isotope, target almost any solid organ tumor in the body using the standard interventional radiologic means and leverage the breadth of the human vascular system. Rhenium-188, not 186, but rhenium-188 nanoliposome biodegradable alginate microspheres, we call 188-RNL-BAM, or just BAM for short, is a next-generation fully-resorbable technology that solves many of the existing problems with current radioembolic technology that's been out there for many decades. The BAM technology incorporates uranium-188 isotope for use as the radiotherapeutic source with a different admission criteria and characteristics than 186. It emits a high-energy beta particle, but with a half-life of only about 17 hours, but a longer path length of over 3 millimeters. It also produces gamma energy that we can use for high-quality, real-time imaging of the BAM construct in the organ. The company will initially focus on developing the BAM technology as a next-generation radioembolization therapy for liver cancer in which it blocks the hepatic artery segments that supply blood to the tumor while also providing radiotherapy by directly irradiating the tumor. Liver cancer is a rare disease with an increasing annual incidence and a five-year overall survival rate of only about 20%. The global opportunity for localized embolization, chemoembolization, radioembolization for primary and secondary cancer in the liver is about a billion-three opportunity globally. We have three objectives in 2022 for our BAM program, the technology transfer phase, which has been completed, and we are on track to complete key CNC feasibility studies, IND-enabling preclinical studies, and an FDA pre-IND meeting this year. So with that, I'll turn the call over to Dr. LaFrance. Norman?
spk06: Thank you, Mark. Following on Mark's comments in 2022 in our GBM clinical development plan to extend the existing respect GBM trial and program into a strong development plan. First and most importantly is to respect GBM phase two registrational trial using the cohort six recommended phase two dose that Mark mentioned earlier. The company and its key advisors believe the safety profile and the clinical efficacy signal of a potential doubling of overall survival in patients with the absorbed radiation doses greater than 100 gray has the potential to be an approvable NDA for recurrent GBM. Pending the outcome of our planned FDA meetings, our two planned FDA meetings, we will initiate the first sites for that registrational trial by year end. In the interim, we'll be executing our clinical operations plan to be ready to achieve this milestone. Second is the continuation of the phase two dose escalation trial supported by NCI for larger tumors. And third is a phase two multi-dose extension trial for patients previously treated and patients that will be treated in the two trials just mentioned. In terms of GBM data presentations for 2022, we plan to provide key GBM clinical updates at the following medical meetings. The Society of Nuclear Medicine meeting this June in Vancouver, the Snow ASCO-sponsored clinical trials and brain mets meeting in Toronto in August, EANO and ESMO in Vienna and Paris, respectively, both in September, and potentially the EANM in Barcelona in October and the Snow annual meeting in Tampa in November. Additionally, I'll be participating at the Metadata Synthetic Control Arm-focused Industry Roundtable next week on April 26th. As Mark mentioned, our clinical team and investigators were very pleased with the first patient outcome and respect LM trial. Treating the first patient of any new condition with an investigational drug is always an exciting but with many unknowns. A few comments. The feedback from one of the very experienced investigators in the trial was that they had never seen such a clinical response in the first patient in the phase one first-in-man trial. The delivery of RNL in this trial is very simple and straightforward, a five-minute outpatient procedure through an existing OMAIA reservoir. There are substantial existing biomarkers, such as tumor cell count, which we are measuring with CSF, which is simple to obtain in these patients. There are also a number of additional exploratory biomarkers we are looking at as well. Additionally, PLUS will perform several preclinical studies to evaluate additional LM treatment paradigms with RNL with 186-RNL, specifically multi-dose administrations and combination treatment with immunotherapy such as PARP and checkpoint inhibitors, both known to be synergistic with radiation. Despite impressive initial results at the first dose with a single-RNL monotherapy, PLUS believes optimal patient benefit can be amplified with multiple-RNL doses and or combination therapies. For our current trial, I'm optimistic enrollment will proceed rapidly based on the significant unmet medical need, very well tolerated and easy dose administration, and the enthusiastic responses received from investigative clinical sites along with other oncologists once they hear of our trial. Developing pulmonary clinical data and medical meeting presentations planned for LM in 2022 were presented a few minutes ago. And finally, RNL is being developed for pediatric brain cancer.
spk02: The key goal here is to obtain FDA IND approval hospital in Chicago on our track to hit this milestone later this year.
spk06: Next, I'll turn the floor to our CFO, Andrew Sims, who will review financials. Over to you, Andrew.
spk05: Thank you, Norman. And good afternoon, everyone. Please refer to our press release issued earlier today for a summary of our financial results. for the 2022 first quarter ended March 31, 2022. As of March 31, 2022, cash and cash equivalents were 21.2 million compared to 18.4 million as of December 31, 2021. This represents 18 to 24 months of cash on hand. Cash used in operations for the three months ended March 31, 2022 was 3.9 million. compared to $3 million in the first quarter of 2021, with the main changes between 2021 and 2022 as follows. Total operating expenses for the first quarter of 2022 were $3.9 million, compared to total operating expenses of $2.5 million for the first quarter of 2021. Approximately $0.7 million of this increase is due to research and development expenses, and 0.6 million is due to legal, intellectual property, and professional fees in 2022. Interest expense decreased from 247,000 in the first quarter of 2021 to 198,000 in the first quarter of 2022. This decreased cost reflects the principal pay down that commenced in November 2021 on the Oxford debt. Net loss for the first quarter of 2022 was 4.1 million, or 19 cents per share, compared to a net loss of 2.7 or 33 cents per share for the first quarter of 2021. And now I'll turn it back to you, Mark.
spk01: Great. Thank you, Andrew. Before we move on to Q&A, let me just summarize key milestones anticipated for 2022. First, with respect to the 186 R&L GBM trial. We're planning for clinically focused FDA meeting mid-year 2022 to propose a phase two registration clinical trial and trial design using the cohort six, 8.8 slash 22.3 millikurie dose as detailed earlier. We expect to initiate the phase two towards the end of the year. We anticipate the CMC focused FDA meeting in the second quarter of 2022, perhaps the beginning of the third quarter, And to clarify, that's to resolve any open CMC issues that may exist at that time. Regarding drug availability, very important that we have GMP drug availability to proceed with the trial. We're on track, but CMC activities for RNL, we plan to complete those and have that GMP phase three ready drug supply available by mid-2022. Also in 2022, we'll report phase one to data and enrollment updates in an ongoing manner, as Norman mentioned, for the RESPECT-LM trial, and our goal is to complete enrollment in at least the initial two cohorts this year. Regarding the pediatric brain tumor trial, we plan to get our INDs submitted relatively soon this year and be able to initiate that trial towards the end of the year. Regarding our recently acquired rights to the 188 R and L BAM, radial embolization therapy technology. We plan to complete key CMC and FDA IND enabling studies and a pre-IND meeting also this year. So at that point, I think we'll move to Q&A, and I'll turn the call over to Gretchen. Gretchen, back to you.
spk00: At this time, if you'd like to ask a question, please press the star and 1 on your touchtone keypad. If at any point your question is answered, you may remove yourself from the queue by pressing the pound key. Again, we do ask that while you pose your question, please pick up your handset to provide optimal sound quality. Thank you. Our first question is coming from Ed Wu from Ascendant. Your line is open.
spk03: Thanks for taking my question. I was wondering, you have a couple of meetings planned with FDA this year. Do you know if the timing has reverted back to normal post-COVID, or do you see that there's still possible delays that this possibly, you know, running a little bit longer than you expect?
spk06: Ed, Norman, would you answer that? Ed, that's a great question. We won't know until FDA gets back to us, but I'm anticipating they'll probably follow their published guidances for these meetings, meaning they'll provide an answer usually within three or four weeks and the meeting date by 75 days. They, as you know, they have the right to actually move those meeting dates up sooner than the PDUFA guidances require them. But I'm not anticipating those to be pushed out further than usual as they were occurring earlier in the pandemic.
spk03: Great, thank you. Then my last question is, you know, your current, you know, GBM trial is funded by the NIH. Do you anticipate trying to get additional funding for some of these other indications that URAs are working on?
spk01: So, one of the reasons we were based in Texas is because there are opportunities for Texas-specific oncology-related grants, as I know you're aware. That's called CPRIT. And we've been very interested in obtaining CPRIT funding for our various programs. Unfortunately, for the GBM program, they typically don't fund phase three trials, but they will fund phase one to phase two. So that's definitely something that's of interest. We're up at the plate with CPRIT and will continue to be. They have two funding cycles a year. And so we spend a lot of time trying to find non-dilutive ways to obtain funding like secret. So we'll continue to do that. But as per our previous plan, we won't talk about specific grants we command. But once we and if we get something approved and funded, we'll certainly talk about that once we're notified.
spk03: Great. Well, thank you. And I wish you guys good luck. Thank you.
spk02: Thank you.
spk00: And once again, if you do have a question, you may press star 1 on your telephone keypad at this time. We'll take our next question from Sean Lee at HC Rightwing.
spk04: This is Sean Lee from HC Wingright. Thanks, guys, for taking my questions. My first one is on the LAM study. It's great to hear that the The first patient is doing well, but traditionally with chemotherapy, interstitial chemotherapy to treat ALM, one of the issues that they face is that there is insufficient penetration of the drug into larger solid tumors.
spk02: So I was wondering, is that something that you guys could potentially face with R&L as well? Hey, Sean.
spk01: Great question. So with leptomeningeal disease, there's two types. One is linear and the other is nodular. The nodular tumors can be a few millimeters and focal, whereas you have sort of more linear disease, which can be very thin but is just on the lining of the leptomeninges. So with that sort of as a background, one of the things we're excited about with with R and L is it does have some penetration characteristics. It's delivered within the CSF. It has a path length, an average path length of about two millimeters, but it can have path links up to closer to four millimeters. So, you can actually get some penetration in nodular disease as well as hitting the linear disease. So, we think that this could have a better effect in chemotherapy because of some of the limitations of chemotherapy and some of the benefits of a radiotherapeutic. And I just would maybe solicit Dr. LaFrance to see, he's an expert in this area, see if he has anything to add.
spk06: I think it's a great question. And one of the unique characteristics of the ELM study design and unfortunately these tragic disease complications of these patients is the leptomeningeal metastases really spread along the leptomeningeal membrane throughout the subarachnoid space. And you're absolutely right. Whether you use systemic chemotherapy and even CSF-administered chemotherapy, systemic challenge of getting there. So you're spot on in that observation. And when administered intrathecally, It usually doesn't, you know, it escapes the CSF very rapidly. As you may know, the turnover volume of the CSF, which has a volume of about 125 ml, is five times a day. So you have something in there, but very quickly gets, you know, exits out with that kind of circulation. You know, think of it as the CSF physiology, circulation physiology. The RNL nanoliposome design, it gets, you know, it's administered very easily through the Omiya shunt. A patient is not even aware of it. We use a 27-gauge pediatric butterfly needle. It goes in in a five-minute administration time period. They get a little Band-Aid over, which they don't really even need, but a Band-Aid over the administration side on the skin over the Amaya. And it's an outpatient procedure. And we have seen, and as we predicted... Not only is there excellent distribution that you heard Mark describe, the duration of time that Mark also alluded to in his comments at the beginning of the call, we have objective evidence, imaging evidence, because of simultaneous gamma ray disintegration with the rhenium-186 of Rnl-186. product staying in the subarachnoid space for over a week. So given our half-life, basically the product stays there during its effective, you know, energy, you know, particle decay period, and you get full benefit by three or four half-lives the whole time, and you get kind of the full benefit of that product administration. In hindsight, that's probably why we saw this result at this very early, at this first dose, which is a very small dose, six millipuries. And to get this kind of response, I think, as I mentioned, one of our experienced investigators, he has never seen this before. And that's where we were pleasantly surprised. So thank you.
spk04: Thanks, Mark. And thanks, Dr. LaFrance. It's very helpful. My second question is that because with LLAM you're using a slightly different method of delivery, would that place a limit on what kind of radiation dose you're able to deliver compared to the GDM study?
spk06: You know, I appreciate that question because that's actually the benefit of the delivery in LLAM makes it so easy. So instead of having the amount that we will deliver is going to be part of our dose escalation trial, and we'll find that out. But I guess to really cut to the quick of your question, you know, we will go, our next cohort doubles the dose, we're doing the administered dose, and the next cohort after that doubles it again. So by, we hope by year end we'll have experience at four times the dose we're using now, given The response we saw on the first patient, and given some preclinical work, we're going to start on combination therapies or multiple dosing therapies. I don't think the amount of administered dose delivery will be an issue. So you're absolutely correct that we're delivering it differently. That actually turns this into an outpatient therapeutic process as opposed to the required inpatient, albeit only a few days for the CED delivery.
spk04: That's great to hear, and certainly looking forward to the results later this year. And my final question is on the upcoming Phase 2 GBM study. So, other than the CMC part, and you're waiting for the FDA meeting as well. So, what else does the company need to prepare before you're able to initiate that study?
spk01: So, as we… Let me just give an overview. I know what you're going to say, actually. So, a big part of what we need to do, Sean, is our work with metadata in terms of developing the synthetic control arm. That's going to be an important part of the trial, not only in maximizing enrollment and the randomization scheme, making it more patient-friendly, but also decreasing the cost. We've already done a feasibility assessment with them. We have a strong sense that it's feasible. That will be developed here relatively soon, and then a lot of that will go into the trial. I think that's what you mean. Other than that, it's really just preparing the meeting package and the protocol synopsis and the statistical analysis plan and so forth. And all of those are in progress.
spk02: have the benefit of the ongoing trial.
spk04: Sorry, go ahead. No, that's good to hear. I'm just wondering, just a quick follow-up, would the company seek to get a special protocol assessment with the FDA for this study?
spk01: It's possible. I don't know that we need one, honestly. Norman, do you have any thoughts about that?
spk06: That's a great question, and people always look to the SBA. Given our synthetic control arm approach, uh this being a rare orphan disease we already have fast track um the potential for breakthrough therapy certainly is there um you know getting a special protocol assessment you usually have to go to the fda and that actually would probably add time so we're in very good shape to proceed about as rapidly as possible in drug development given what we have given the preliminary efficacy signal given a very solid control arm that already has precedent at FDA for being accepted in GBM in particular. So an SPA, I think, would be kind of redundant and would require additional FDA meetings and some interactions and negotiations. We believe by summer we'll have an agreement, third quarter, and be able to have sites initiated by the year end. You're very correct that we have to interact with FDA first, but we're doing it the fastest way possible.
spk02: I see. Thanks for that. And that's all the questions I have. Thanks, John.
spk00: Once again, if you do have a question, you may press star 1 on your telephone keypad at this time. And it appears we have no further questions at this time. I will now turn the floor back over to Andrew Sims.
spk05: Thanks, Gretchen. I have a question that was emailed in on the GBM trial. So the question is, it sounds like you're working towards a phase two or registrational trial on GBM towards the end of 2022. What details can you provide about the trial design, including patient numbers?
spk01: So the answer is, I can't tell you anything definitively because we haven't talked to the FDA, but I can give you some guidance as to how we're thinking about it. And I think we've got a pretty reasonable level of confidence at this point that we're pretty close. Everything is dependent, of course, on what the FDA says. So in terms of number of patients, as we've said before, we think it's possible to have a successful registrational trial with 100 patients. I think we're going to be between 100 and 200 patients. We'll know more after we talk to the FDA. Primary endpoint will be overall survival. I think that's clear, and that is typical in GBM trials. On a randomization scheme, you know, typically for rare disease, you might see a two-to-one randomization scheme or more typically a one-to-one randomization. One of the benefits of the synthetic control arm is that a randomization scheme where it's like a three to two to one perhaps, which has been done before where three patients get treated and two patients in the control group come from your synthetic control arm, and then you actually randomize one patient to your likely control arm. So three out of four patients end up getting treated, which is very good for enrollment and good ethically for these patients. So that would certainly help cost and timing and so forth. So we're kind of hoping it's something more like that, which is something that a synthetic control arm can provide. On a control perspective, I think very likely we'll go to a comparison against MD preference, which is essentially a kitchen sink approach. That's what these patients get because there's really no clear standard of care. These patients are in an extreme situation and and there aren't good options. So from a, I guess, a budget perspective, with a synthetic control arm and a lower trial size, we think this trial could be closer to $10 million. We've kind of been previously guiding to maybe closer to 20. I would say $15 million is probably a pretty good number. And what else? I think in terms of sites, I think probably 10 sites makes the most sense, particularly for on the lower end of that 100 or so patients that are in the trial. And those really respond with what we know are world-class sites in terms of convection-enhanced delivery, which is a key part of the therapeutic design. And then finally, in terms of timing, You know, close to 100 patients, I think this trial could enroll 10 sites, you know, maybe in 12 months if we get a good running start. This could take 18 months, but 12 to 18 is reasonable. Depending on the outcome and, you know, what the clinical benefit is, I think we're looking at kind of a 12 to 18-month follow-up period. So we're looking at a trial that lasts 24 to 36 months, hopefully closer to 24 months. So, all that to say, this is what we're thinking. I'm kind of giving you ranges.
spk02: It's going to be dependent on what the FDA says. Gretchen, are there any other questions?
spk00: No further questions over the phone. Thanks.
spk01: Okay. Yeah, let me finish up. Thank you, Gretchen and Andrew. So just to close, I want to say thank you to everybody that joined us on the call and for those that are listening on the recorded version, thank you. And on behalf of the board, I'd just like to thank once again our employees and the broader members of our team, our consultants and so forth, the physicians that we work with, and of course the patients that trust us. Thank you very much for your participation and have a good evening.
spk00: Thank you. This does conclude today's conference call. Please disconnect your line at this time and have a wonderful day.
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