Good afternoon, ladies and gentlemen. Welcome to the Plus Therapeutics Third Quarter 2022 Results Call. 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 risks and uncertainties, including the risks and uncertainties described under the Risk Factors section included in Plus Therapeutics' annual report 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. Marc Hedrick, Plus Therapeutics' President and Chief Executive Officer. Sir, you may begin.

Thank you, Josh. Good afternoon, everyone. And 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 third quarter financial results. Joining me for 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 clinical progress before turning the call over to Andrew to review our financials. Dr. LaFrance will be joining us for Q&A. The company made perhaps the most progress ever in a single quarter that I can remember. First in September 2022, results from the company's Phase 1 ReSPECT trial for recurrent GBM were presented at the European Society for Medical Oncology Meeting in Paris by Dr. Andrew Brenner, the trial principal investigator. In summary, 21 patients across six dosing cohorts received 1 to 22 mCi radiation and 0.6 to 8.8 milliliters of volume. The mean tumors treated in those 21 patients was 8.3 milliliters, and patients had a mean of 1.7 recurrences and challenging prognostic factors. All recurrent glioma patients had computerized treatment planning and up to four intracranial catheters placed. Each patient received a single administration of 186RNL by convection-enhanced delivery, and whole-body planar SPECT/CT imaging was performed on days one through eight following treatment to assess dosimetry and radiation distribution. Patients were followed for safe radiation delivery and overall survival. The mean absorbed radiation dose to the tumor was 271 Gy with negligible systemic exposure. There were no dose-limiting toxicities, and the overall safety profile was favorable. Patients were stratified by mean absorbed radiation dose to the tumor. Those receiving greater than 100 Gy mean therapeutic dosing (12 in that group) had a median and mean overall survival of 129.7 and 106.4 weeks respectively, with four patients still alive in that group. Patients receiving less than 100 Gy mean absorbed doses (nine in that group) had a median and mean overall survival of 22.3 and 24.6 weeks respectively; none of those patients remain alive. Kaplan-Meier analysis of patients receiving a mean absorbed dose greater than 100 Gy versus those with less than 100 Gy showed a statistically significant difference in overall survival favoring those that received a therapeutic dose. The study concluded that a single administration of 186RNL by convection-enhanced delivery in recurrent glioma patients with poor prognosis is feasible, safe, and potentially effective in increasing overall survival when a therapeutic dose of radiation is delivered to the tumor. A recommended Phase 2 dose of 22.3 mCi in 8.8 milliliters was selected for patients with tumors of up to 20 CCs in the Phase 2 trial plan for later this year. And I'll discuss the Phase 2 plan further momentarily. Also during Q3, we received guidance from two Type C meetings with the FDA on the next steps in our program for the development of our lead investigational drug Rhenium-186 Nanoliposome. The first Type C meeting focused on the company's Current Good Manufacturing Practice, or cGMP clinical and commercial manufacturing process for 186RNL. The FDA indicated agreement with our proposed application of cGMP guidance for radiotherapeutics, small molecule drug products, and liposomal drug products for 186RNL in support of our ongoing and future glioblastoma clinical trials, manufacturing scale-up, and commercialization. We expect that this FDA feedback will apply to 186RNL used in other clinical development programs including leptomeningeal metastases and pediatric brain cancer. I'm happy to report that we have now completed all key manufacturing objectives for cGMP 186RNL production to support ongoing and planned clinical trials in 2022 and beyond. During a separate clinically focused Type C meeting, the FDA and Plus agreed that the respect GBM clinical trials should proceed to the planned Phase 2. The key focus areas of ongoing clinical investigation in the recurrent GBM development program will be further dose exploration, including both increased dosing, i.e., advancing to cohort eight, and the study of multiple doses, alongside collecting additional safety and efficacy data to inform the design of the future registrational trial. In addition, during the meeting, there was agreement that in the planned future registrational trial, overall survival should be used as a primary endpoint. The company and the FDA also agreed to hold future meetings to consider the use of external data to augment the control arm in the registrational trial, facilitated by our orphan and fast track designations. Earlier this month, an IND amendment was submitted regarding this plan that sits with the FDA as of today. The planned Phase 2 trial design will incorporate the following features: The cohort six dose, which will be used, is also the recommended Phase 2 dose from cohort six as mentioned, which will be 22.3 mCi in 8.8 milliliters of volume. The study will roll up to an additional 31 patients at five planned sites, including the current three sites plus an additional two sites that are currently in the process of coming online. Subjects will remain on study until disease progression by RECIST criteria recognizing, of course, the potential for pseudoprogression that complicates their use of RECIST criteria. We're working on the imaging analysis today to resolve that issue, or potentially a principal investigator's decision that's in the best interest of the patient. The primary endpoint, as mentioned, will be overall survival following a single administration; secondary endpoints will assess the safety, tolerability, objective response rate, partial response, serious treatment emergent adverse events, and progression-free survival at six months. We'll make known the final details pending further feedback from our IND amendment, which is with the FDA as mentioned. I'll now pivot to discuss our leptomeningeal metastases program. Our team was very honored to learn in the third quarter that we had been awarded a $17.6 million product development research funding award from the Cancer Prevention & Research Institute of Texas, also called CPRIT. This award will cover the majority of the development cost, including funding for up to 150 enrolled patients for our leptomeningeal metastases program over three years. For those who aren't familiar with CPRIT, CPRIT is the second-largest global public funder of cancer research in the world after the NIH, with $6 billion allocated by the state. Also of note, Plus's $17.6 million grant award is the largest in the most recent CPRIT review cycle, and one of the top 10 largest all-time awards by CPRIT in its history. Besides this asset, the award is a material source of non-dilutive funding that significantly strengthens the company's balance sheet and extends our expected cash runway. Andrew will provide some greater perspective on that momentarily. While this is all exciting news, let me just back up a bit and recap our current development plan starting with our Rhenium 186 Nanoliposome development. As I mentioned, the company recently completed key manufacturing objectives for cGMP 186RNL to support ongoing and planned clinical trials in 2022 and beyond, producing drug of sufficient quality and scale to enable the completion of all further clinical investigations, including ongoing and planned Phase 2 and Phase 3 clinical trials in patients with glioblastoma, leptomeningeal metastases, pediatric brain cancer, and potential future disease targets. Having access to cGMP drug is an important milestone as we prepare to transition from early to late-stage clinical investigations and commercialization. Relatedly, I'm pleased to announce that the World Health Organization has approved rhenium 186 bis-BMEDA as a generic name for 186RNL. As required, this generic name will be used in all future IND and NDA submissions, and branding development and related go-to-market planning is currently in process. Hereafter, we will now use the rhenium 186 bis-BMEDA name in lieu of the 186RNL research name. Regarding the GBM program, based on the positive safety profile and promising efficacy signals observed thus far, with clear feedback from the FDA, most importantly, we intend to move into Phase 2 in the U.S. by the end of 2022. That effort will be funded, to a significant degree, as it has in the past, by the U.S. NIH National Cancer Institute. Second, pursuant to FDA guidance, we intend to continue the dose escalation to cohort eight, which is a 16.6 milliliter volume and 41.5 mCi infused dose, representing an approximate 33% increase above the volume infused and radiation dosage. Notably, we recently received the SMB approval to advance to cohort eight from cohort seven. Any further escalations in volume or dosage will be based on observations from cohort eight. But again, the overarching goal here is to dose escalate until we reach dose-limiting toxicity or the maximum practical dose. The ongoing Phase 1 study is intended to explore further dose escalation on large tumors as we have yet to observe any dose-limiting toxicities. We are also continuing to work to further optimize the delivery and dosing approach. This week at the 35th annual Congress for the European Association of Nuclear Medicine, the company presented data that indicated the direct administration of rhenium bis-BMEDA is safe in patients with recurrent GBM, with no dose-limiting toxicities in 24 total patients treated thus far; I refer you to that press release for further information. Now on to our leptomeningeal metastases or LM development program. That trial is a multicenter Phase 1/2 dose escalation study to determine the maximum tolerated dose, safety, and efficacy of 186 rhenium bis-BMEDA. LM is an end-stage fatal complication associated with advanced cancers that infiltrate the fluid line structures of the central nervous system or leptomeninges. The incidence of LM is growing with better local cancer care, and there are no FDA approved therapies. Standard treatment includes external beam radiation therapy to affected sites, followed by chemotherapy given either orally, intravenously, or often administered twice weekly directly into the CSF space. In the third quarter of 2022, the company initiated enrollment of cohort 2, which represents a doubling of the dose over cohort 1 in the ReSPECT LM dose escalation trial. We anticipate completing enrollment of cohort 2 by the end of 2022 and cohort 3 by the end of Q1 2023. In cohort 1, 186 rhenium bis-BMEDA was successfully delivered without dose-limiting toxicities, and the independent respect LM DSMB approved the plan to move forward with cohort 2. By the way, also at the annual Congress of the European Association of Nuclear Medicine this week, the company presented data demonstrating that 186 rhenium bis-BMEDA administered through an intraventricular catheter at 6.6 mCi in 5 CCs achieved absorbed dosages of 18.7 to 29 Gy to the ventricles and cranial subarachnoid space, which was well tolerated with no treatment-related adverse events greater than grade one. Additionally, all three patients in the cohort were observed to have prompt and complete 186 rhenium bis-BMEDA distribution throughout the CSF that was durable past one week and very well tolerated. All patients showed a decrease in CSF cell count by microfluidic chamber assay after treatment, ranging from a decrease to 45% up to 92%, which was also durable. Now regarding our development program and pediatric brain cancer, the company is on track to meet its objectives to submit an investigational new drug application in the fourth quarter of 2022, for what will be called the ReSPECT PBC Phase 1 dose-finding and efficacy study of 186 rhenium bis-BMEDA for pediatric brain tumors, which will be submitted in conjunction with our lead academic institution, the Hospital of Northwestern University in Chicago. Finally, regarding our novel in-licensed radioembolization microparticle technology called 188RNL-BAM, we have completed the technology transfer phase and key CMC feasibility studies. We are on track to submit a pre-IND meeting and have that meeting by year-end. With this resorbable biomaterial embolic technology coupled with a highly potent radiotherapeutic in this case, 188 rhenium, we can target almost any solid organ tumor in the body using standard interventional radiologic means and leverage the breadth of the human vascular system to selectively reach almost any tumor. Rhenium 188 Nanoliposome biodegradable alginate microsphere is a next-generation fully resorbable technology that solves many of the existing problems with current radioembolic technology that have been in the market for many decades and represents an existing total addressable market of about $1.3 billion. The company will initially focus on developing the BAM technology as a next-generation radioembolic therapy for liver cancer. Liver cancer is a rare disease with an increasing annual incidence globally and a five-year overall survival rate of only about 20%. So with that summary, I'll turn the floor over to our Chief Financial Officer, Andrew Sims, who will review the financials.

Thank you, Marc. Good afternoon, everyone. Please refer to our press release issued earlier today for a summary of our financial results for the 2022 third quarter ended September 30, 2022. As of September 30, 2022, cash and cash equivalents were $20.3 million compared to $18.4 million as of December 31, 2021. The company believes the combination of current cash, committed grant funding, in conjunction with existing discretionary capital sources secures our cash runway through 2025. Cash used in operations for the nine months ended September 30, 2022, was $10.7 million compared to $7.7 million in the same period for the previous year. The main year-over-year changes between the third quarters of 2022 and 2021 are as follows: Grant revenue of $73,000 was reported related entirely to CPRIT. Total operating expenses for the third quarter of 2022 were $5.2 million, compared to $3.5 million for the third quarter of 2021. The increase is due primarily to the following: CMC-related activities to develop and produce cGMP quality drug material, as well as expenses associated with developing the synthetic control arm platform for future clinical trials. These projects and related spend have now been substantially completed, and to a lesser extent, there was an increase in legal IP and other general corporate expenses. Interest expense decreased from $232,000 in the third quarter of 2021 to $173,000 in the third quarter of 2022. This decrease reflects the continued principal paydown that commenced in November 2021 on the company's Oxford debt. Net loss for the third quarter of 2022 was $5.2 million or $0.19 per share, compared to a net loss of $3.7 million or $0.28 per share for the third quarter of 2021. I'd also like to take this opportunity to provide an overview of the positive impact on cash and the financial statements of the $17.6 million CPRIT grant to develop the ReSPECT LM indication. As disclosed in the September 22, 2022 press release, this grant covers the three-year period ending August 31, 2025, with the funding tracking the company proposed clinical development plan. The total planned grant for year one is $3.7 million, increasing to $6.7 million in year two, and $7.2 million in year three. Let me walk you through the cash impact of CPRIT and the process to access the $17.6 million. CPRIT initially funds 50% of the first-year budget, which for Plus is just under $1.9 million. The request for this $1.9 million has been submitted, and we expect to receive this funding within the next one to two weeks. Once greater than 90% of this initial $1.9 million is utilized, the next request will be submitted. CPRIT typically takes less than two weeks to advance the requested funds. The design of the funding ensures the company is not out-of-pocket for grant-related expenses, which will obviously be substantial. Quarterly reports are submitted summarizing payments and development progress during the previous quarter, and CPRIT has the right to conduct an annual audit of expenses. These are typical requirements especially for such substantial levels of funding. As Plus incurs costs, the costs will be reported in our income statement under the Research and Development line item, and the matching CPRIT grant will be reported as revenue in the grant revenue line on the income statement. Note seven on Page 11 of Form 10-Q outlines the accounting of finance for the grant and associated project-specific costs. Now I will turn it back to Marc.

Thanks, Andrew. Before we move to Q&A, let me just summarize key milestones anticipated for the remainder of 2022. We plan to complete the enrollment of cohort 2 of 186 rhenium bis-BMEDA for recurrent GBM, as mentioned. We plan to present updated data from the ReSPECT GBM trial, the LM trial, and forthcoming pediatric brain cancer trials at the Society for Neuro Oncology Annual Meeting and Education Day to be held in Tampa in November. We'll complete Cohort 2 of ReSPECT LM Phase 1/2 dose escalation trial in Q4. We'll submit an IND for the study of 186 rhenium bis-BMEDA in patients with pediatric brain cancer, as mentioned, and we plan to complete key CMC and IND enabling studies for the BAM program and complete a related pre-IND meeting as planned, all on track. At this point, now let me turn it back to Josh for a Q&A session. Josh, let's have questions if there are any.

Thank you. Our first question comes from Justin Walsh with Jones Trading. You may proceed.

Hi, thanks for taking the questions, and congrats on all the progress. My first one, it's great that we're seeing decreases in the CSF tumor cell count in the LM patients. But it looks like the cell counts have rebounded in at least some of these patients treated so far. I know that we're in the early phases of dose escalation here and repeat dosing might be key. But how do you think we should interpret these readouts? Is there a reason to expect some potential benefit from a temporary reduction in the CSF tumor cell count? Or do you think the major takeaway is that we are just potentially seeing some anti-tumor effects and we need to wait a little longer for clinically meaningful readouts?

I appreciate the question. Let me break it down. I will address part of it and then refer to Dr. LaFrance to discuss a recent patient experience. One of the great aspects of the LM indication is the ability to monitor tumor markers, starting with the tumor cell count, which we track over time in all patients. It's encouraging to see that even at the lowest possible dose, which is almost homeopathic, there are significant decreases in all patients; every patient experienced a reduction. That's important. Additionally, there is a lasting effect, as it appears to persist for about a month. We know from the dosimetry data that radiation lasts for at least a week, likely longer. This seems to reflect what we've observed in GBM patients. So, there is a duration of effect with meaningful changes even at a very low dose. The next question is whether this is the right tumor marker to evaluate. The answer is maybe. We are currently collaborating with a principal investigator; we have submitted a grant proposal to explore additional tumor markers related to radiation damage, and we plan to study that regardless of the grant's status. There are numerous opportunities to investigate tumor markers in this clinical model. Lastly, the significance of these tumor cell markers remains uncertain. Dr. LaFrance mentioned at a recent meeting in Barcelona that one patient showed significant improvement in clinical symptoms despite having the lowest reduction in tumor cells. Norman, would you like to comment on that?

Well, I'll start with that. Thanks, Marc. And I think it's a great question, by the way. And I'll start with the last patient, Marc just alluded to. One caveat that Marc didn't mention is that this patient was responding to chemotherapy. So in fact, his cell counts were much higher, and our continued therapy; he didn't tolerate that chemotherapy, he came off of it. But we maintained that benefit. More importantly, this unfortunate patient was wheelchair-bound and had significant pain and other neurological manifestations, and after the therapy, within a few days, his doctor, who is the principal investigator at that site, reported that the patient was out of the wheelchair, walking, albeit with some assistance, but minimal assistance, and his pain was significantly decreased. Your point about the duration of the benefit, I want to emphasize Marc's point that we are at the absolute lowest dose. We will continue to advance to cohort 2, and we will double again in cohort 3. It’s important to see these next cohorts, as we will have a fourfold range of doses, which will give us a pretty good idea. The registrational trial, which we are still determining how it will look, will require that we identify adequate dosing and evaluate other endpoints after discussions with the FDA. The best way for LM, a devastating complication, may involve multiple doses to manage this serious issue that severely affects patients' quality of life. They experience leptomeningeal complications beyond what is provided by available chemotherapy.

Thank you. You got it. Thanks. A couple more questions, if that's alright. Sticking to the trial design. I believe that the ReSPECT LM trial is enrolling LM patients with any primary tumor type. I'm wondering if you think that it's possible that 186 RNL could receive a broad LM label upon potential approval, or do you think primary tumor type will play an important role and maybe limit the breadth of the label down the line?

Good question. As you probably know, the FDA almost always desires disease-specific indications. While solid tumors have the potential for leptomeningeal complications, breast and lung cancers are by far the most common sources. Based on that, we will certainly focus on these high-incidence contributors. We will discuss with the FDA as we collect initial data, with other tumor types represented. However, it may make regulatory sense, or even be required, that we focus on disease specificity. There are other grant capabilities we have for further funding. I like your idea of a broad indication, but we are among the most highly regulated industries on the planet, and the FDA has its criteria. It's usually disease-specific.

Got it. Thanks. And one more for me. I'm just wondering if you can provide any color on what we might expect to see at the SNOA conference. Obviously, there isn't a lot of time between SNOA and the EAMM conference. So just wondering if you think that maybe we'll see one or two more patients, or just what we can kind of look forward to there.

Yes. I wouldn't expect transformational news. I think the goal here will be to provide incremental updates. The rationale is that we are moving from what has been mainly an academic study, to transitioning into Phase 2 in GBM, and working to accelerate enrollment in LM. We aim to raise awareness among the neuro-oncology community. There will be an investigator dinner, and we will bring in new sites for these trials very soon, both the GBM trial and the LM trial, as well as the pediatric brain cancer trial. While we aim to present significant updates, it is more about creating visibility within the community, which has been receptive thus far.

You're right. The timing between the meetings is close, and the likelihood of recruiting a few more patients is also there. We'll share that data. Importantly, the data we've had is consistent; both in GBM, as we approach these higher efficacious dose levels. Remarkably, in LM, all patients have behaved the same way. They've had decreases in CSF tumor counts, and their distribution and tolerability have all been right on target and exactly the same. Typically, you would see more variability, but one of the strengths of radiopharmaceuticals is that we expect this consistency to persist, and thus we expect consistent data as we continue monitoring.

Got it. Looking forward to it regardless. Thanks for taking all the questions.

Thanks, Justin.

Thank you.

Thank you. One moment for questions. Our next question comes from Edward Woo with Ascendiant. You may proceed.

Yes. Thank you for taking my question. I just want a clarifying question; you mentioned that with the grant and your current source of cash, you have enough to last through to 2025. Does that include all three clinical trial costs?

Ed, thanks. I appreciate the question. The short answer is yes, it does. I'm still pinching myself from the kind of recovering from the announcement of the CPRIT grant, which is obviously transformational for the company. So we are positioned today where the lead indication GBM by the NIH, our second indication for leptomeningeal metastases Phase 2, and we expect that enrollment will be limited, about six to ten patients per year for pediatric brain cancer. I would add that we do not yet have funding or grant support for that indication, but as Marc and I have communicated in previous earnings calls, the management team is focused on non-dilutive funding sources, and given the success we've had, we will continue that approach.

Great. Well, definitely congratulations for all the guys; that grant is definitely a game changer to prevent investors from getting too excited or whatnot. But what are the opportunities and grants that are out there? Are there other avenues, or is this pretty much the main thing that you are focused on? Are there other grants and opportunities or similar avenues?

Yes, there are, Ed. It's Marc. We have two avenues: One axis is to work with our academic collaborators to develop grants to study, potentially for side projects, and we're working on one related to novel biomarkers in the LM trial, which would help the research. Another area involves CPRIT funding; we moved the company to Texas for better access to state support for cancer funding, and now that we have secured substantial support, we believe we can continue to leverage the CPRIT potential for additional grants. Further, there are opportunities corporately beyond CPRIT, including NIH and the Department of Energy; these are radiopharmaceuticals and connected to nuclear energy. We have brought on Dr. Melissa Moore, a superstar director of Clinical Operations, who has expertise in this area and enhances our team's capabilities.

Great. Well, congratulations, and wish you guys good luck. Thank you.

Thanks, Ed.

Thank you. One moment for questions. Our next question comes from Sean Lee with HC Wainwright. You may proceed.

Good afternoon, guys, and congrats on all the progress. My first question is on the repeat dosing; that's something that you've mentioned for the last quarter. So I was wondering whether that’s something that you look to try in the upcoming Phase 2 study, or is it going to be a separate cohort in the current Phase 1 study? Or do you plan to start another, a new study just for the repeat dosing?

Hi, Sean. Thanks. It'll be a separate study; the protocol has been approved by the FDA. As you can imagine, for repeat dosing, it's based on recurrence, and with a relatively small number of patients that have received the treatment thus far and this being a recent development, sporadic opportunities will arise. The rationale is to explore the safety of multiple doses and get the FDA comfortable with that. We could consider instances where unique tumor morphology affects treatment delivery efficiency. Therefore, having a protocol to treat patients after postoperative dosimetry evaluation will be essential. Thus, we are striving for long-term survival, but managing these patients may require a re-treatment strategy years later when a well-treated tumor recurs or earlier post-operative measures when the initial tumor treatment coverage falls short. However, that will be a separate endeavor from the Phase 2 study, which will focus first on single administrations for smaller to medium-sized tumors.

I see. Thanks for the clarification. With regards to the LM study, in the summation, it’s likely going to favor a more primary-to-specific indication. Is there any one that you are leaning towards at this point?

Just to be clear, is that in the LM indication you're speaking about?

Yes.

Great question. Yes, for LM, the most prominent demographic contributors are breast and lung. Right behind them are GI, some head and neck cancers, and another area of interest would be melanoma. We all know that melanoma is on the rise. However, for focus, we have separate funding, so we are already looking at the two highest contributors to leptomeningeal metastases.

If I could just add: As currently structured, our idea is to treat the initial nine patients as all comers and then restrict our focus to breast and lung cancers afterward.

Great. That's all I have. Thanks for answering my questions.

Thank you, Sean.

Thank you. Our next question comes from Yuan Zhi with B. Riley. You may proceed.

Hi. This is Brandon on for Yuan. So you mentioned earlier about the GBM study with the large or complex morphology. We were wondering what percentage of patients you see who have those very large tumors or the morphology that might be too complex to address with a single dose?

Thanks for the question. Our current Phase 2 will proceed at the doses Marc mentioned, putting a conservative volume limit of 20 cubic centimeters. You'd probably get a little more tumor volume, showing that about two-thirds or three-quarters of all glioblastoma presentations fall within that range. In terms of complex morphology, while most will present as nice spherical or ellipsoid shapes, rare cases are difficult tumors; those are small percentage that may fall in the single-digit range, usually not affecting our general strategy. Even regular tumors might benefit from additional doses, based on Marc's reference earlier to our treatment protocols. Therefore, we will continue dose escalation to address the majority of tumors.

Thanks. That's helpful. And then, regarding the LM study, I think you mentioned the potential for repeat dosing earlier. We were just wondering if you would continue the single dose escalation beyond cohort 3 before attempting multi-dosing, or if you would be able to do those simultaneously.

Great question, Brandon. The agreement with the FDA was that we would do nine patients with dose escalation twice through three cohorts, doubling each time as a single administration, and then go back to the agency. My view, based on observations, is that we might be able to see similar effects to what we've seen in GBM, where we could reach higher dosages without significant toxicity. The characteristics of rhenium, its dose rate and density, and the anatomy of the CSF space indicate that the dose length is only about two millimeters. Therefore, you should see limited damage to the white matter while permeating the CSF space. Therefore, the plan would be to continue dose escalation until we identify dose-limiting toxicities and then implement a multiple dose treatment strategy. Some products in development are exploring that idea by using a multi-dosing paradigm up to four doses in those patients. We can also consider titrating dosing to cell counts based on biomarkers, further helping our strategies down the road. We'll define those data patterns based on the forthcoming data and feedback from the FDA.

Okay, well thanks for taking our questions, and congratulations on a very productive quarter.

Thanks a lot, Brandon. Appreciate it. I'm not showing any further questions at this time. I would now like to turn the call back over to Marc Hedrick for any further remarks. Thank you, Josh. Just to close, I want to as usual, thank everybody that joined us on the call today; we're appreciative of your interest in the company and what we're doing. I also want to make sure to remember our employees, the physicians, and scientists we work with on a daily basis. And of course, the patients who enter into these trials and trust us to deliver. I look forward to updating everyone as we move forward, and thank all of our stockholders for their continued support and confidence. Back to you, Josh.

Thank you. This does conclude today's conference call. Please disconnect your line at this time and have a wonderful day.