Good afternoon, ladies and gentlemen. Welcome to Plus Therapeutics' Fourth Quarter and Full Year 2024 Results Conference Call. Before we begin, we want to advise you that over the course of the call, including any 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 positions. 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 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, Sherry. 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 fourth quarter and full year 2024 financial results and go-forward guidance. Joining me for the call today is Mr. Andrew Sims, our Chief Financial Officer. I'll begin the call by providing more detail on four important recent corporate announcements. Then, I'll discuss progress in our most advanced clinical programs and then discuss progress and plans for CNSide and its commercialization. After that, I'll turn the call over to Andrew to review our financials. So first of all, in early March, [Technical Difficulty] an underwritten equity financing of $15 million in gross proceeds with new stockholders. This was preceded by a smaller financing from existing stockholders. We also received about that time $2 million in its accelerated grant proceeds from CPRIT. This capital, in combination with further anticipated grant funds, strengthens our balance sheet and provides funding through key milestones into mid-2026. Additionally, the financings enabled Plus to regain compliance with NASDAQ's minimum stockholders equity listing requirement. Andrew will, in fact, provide additional details on the transactions, future grant availability, and cash runway. On a personal note, and on behalf of our Board of Directors and our dedicated management team, I would like to express our collective gratitude to our current and new stockholders for their support of and confidence in Plus and our mission. We're also grateful to those organizations with which we have substantial financial and grant support, specifically the US NIH, and that's the NCI, National Cancer Institutes, the US Department of Defense, and the state of Texas, specifically CPRIT. Also, moving on, we recently taken to strengthen our senior leadership team. Specifically, for Plus Therapeutics, Dr. Mike…

Thank you, Marc. Good afternoon, everyone. Please refer to our press release issued earlier today for a summary of our financial results for the fourth quarter and full year ended December 2024. The cash and investments balance was $3.6 million at December 31, 2024, compared to $8.6 million at December 31, 2023. The company recognized $5.8 million in grant revenue in 2024, compared to $4.9 million in 2023. This represents CPRIT share of the costs incurred for our REYOBIQ development for the treatment of patients with LM. We expect 2025 grant revenue to be in the range of $6 million to $8 million, of which we've already received [Technical Difficulty] The total operating loss in 2024 was $14.7 million compared to $13.3 million for the full year 2023. The increase is primarily due to increased spend relating to the ReSPECT-LM trial. Net loss in 2024 was $13 million or $1.95 per share compared to a net loss of $13.3 million or $4.24 per share for the full year in 2023. I would also like to provide an update on our runway based on the previously announced private placement and provide guidance on our grant funding for 2025. There are two additional sources of cash to which Plus has access beyond the balance disclosed in cash on hand and liquid investments on our Q4 2024 balance sheet. The first source is the cash from the recently announced private placement closed on March 4th with gross proceeds of $15 million. The second source of cash remains our continued funding through three grants. Firstly, the CPRIT grant to support the ReSPECT-LM trial. Coming into 2025, we have $7.2 million remaining to be received on the grants, of which we received $2 million in Q1 2025, and are on track to receive $1.6 million in Q2, and with the balance to be received in late Q3 or early Q4 2025. Plus also has just over $2 million remaining, the grant proceeds from a reward from the United States Department of Defense for $3 million in total to support the upcoming ReSPECT pediatric brain cancer trial. The first advance was received in 2024 for just under $900,000. Plus also continues to benefit from the NIH grant to support the ReSPECT GBM Phase 1/2 trial. Although expected to be completed in 2025, it currently covers approximately 90% of the overall trial costs. We also continue to source other non-dilutive sources of capital. We will continue to only report on individual grants when they are awarded. In addition, in Q1 2025, we consolidated our operations into our CNSide facility in Houston, streamlining operations and reducing costs. Taken in total, the cash runway is well [Technical Difficulty] being fully funded. And now, I'll turn it back to you, Marc.

Thank you, Andrew. Before we move on to Q&A, I'll take a moment to provide a summary of guidance on anticipated key events and milestones for the remainder of the year. First of all, in terms of data and related presentations, specifically at the Nuclear Medicine and Neurooncology Symposium in May, we'll provide a comprehensive ReSPECT-LM data review of the single-dose Phase 1 trial, including new key safety and efficacy data. In terms of other targeted meetings for the remainder of the year, we plan to contribute abstracts and presentations along the way at a minimum to our core constituencies in oncology, specifically at the Society for Neuro-Oncology, American Society of Clinical Oncology joint meeting in August and the Society for Neuro-Oncology annual conference in November. In addition, besides the submitted abstracts, the company plans to host educational seminar at SNO/ASCO featuring KOL presentations on both REYOBIQ and CNSide potentially at the SNO annual meeting. More on that to come later. In terms of clinical and regulatory milestones this year we are on track to initiate the ReSPECT-LM Phase 1 multiple dose escalation trial and complete the first cohort of multiple doses at the two-month intervals. We're also on track to meet with the FDA this year following completion of the ReSPECT Phase 1 clinical study report, which is in process, to seek agreement with the FDA on a few things. First, the broad issues around the clinical development of REYOBIQ through approval, first for breast cancer, then other cancers. Also, we intend for these meetings to provide us with substantial agreement on key issues, such that we can optimally design a Phase 2/3 registrational trial for both a single dose of REYOBIQ for breast cancer and later to integrate dosing optimization thereafter as additional multiple dose data becomes available.…

[Operator Instructions] And our first question will come from Edward Woo with Ascendiant Capital. Your line is open.

Yeah, congratulations on all the progress that you're making. On the CNSide, do you anticipate building up a major sales force or will you look for partners to commercialize this?

Hi, thanks for the question, appreciate it. So not a major sales force, let me clarify that. This is a niche opportunity. So, in one sense, we're really beginning the sales process with academic neuro-oncologists at major oncology centers, call it the 30 NCI designated cancer centers. That's a relatively small group. There are only about 300 neuro-oncologists in the country. There are a lot more medical oncologists and there are a lot more emergency room doctors even that could use it, but that will come later. The key thing is to launch this into this narrow group of thought leaders and major institutions that probably gets you 80% of the market and then over time expand it out to the broader medical oncology market and perhaps even as mentioned the ER docs. That's well within our capability to execute and finance. And I don't think it makes sense at this point to partner, although at some point partnering in the US and or outside the US will be something that we're going to look at very closely and be predisposed to do.

Great. Well, thanks for answering my questions and I wish you guys good luck.

Thank you.

Thank you. One moment for our next question. And that will come from the line of Jason Kolbert with D. Boral Capital. Your line is open.

Hi, Dr. Hedrick. This is Lindsay on for Jason. First off, I just want to say congratulations on the financing. We just have a few questions for you. The first question is, the recurrent GBM trial is the most advanced. Are you able to lay out what must happen to meet the goal of data this year?

Hi, Lindsay. Yeah, in a way, it's most advanced. Although, if you truly look at the integrated development plans for both, it's very likely that LM could get approved before. But superficially, yes, GBM is in sort of late stage, Phase 2. So, as I mentioned, we've enrolled over 50 patients, including completing a Phase 1, completing a dose escalation over halfway through Phase 2. The key thing has been adding new sites. We've got a flood of new sites that are interested on the heels of the Nature Communications publication. We really don't need more new sites. We now have five sites that are enrolling, now a New York site and now a upper Midwest site. So we've got sort of Chicago area, an upper Midwest covered as well as the Northeast. So we're really talking about 11 patients to complete that. And so that'll be a focus over the next year, and I think that's going to be achievable.

Thank you. And just a follow-up question, can you remind me of the powering assumptions behind the trial? 80% powered for what delta, and then what would be exciting data for that?

So the powering on the -- so the Phase 2, its comparator is essentially a standard of care. We've actually conducted two real-world control arms that we've funded through our partner Metadata, and we have looked at two different comparator arms. One is patients that have been treated with monotherapy with the only approved drug for recurrent GBM, that's bevacizumab. And those patients live under eight months. And that's a relatively large trial. That also compares with publications as well in terms of meta-analysis on recurrent GBM. At the behest of the FDA, who wanted to control for the effects of convection-enhanced delivery, we also looked at patients that received CED but were also demographically mapped to our trial. Again, median overall survival is about eight months. So, kind of any way you cut it, recurrent GBM patients, no matter what you do, live on average about eight months. So that's our clinical hurdle rate. In terms of powering assumptions, if you look at, I'll kind of cut to the chase here, if you kind of look at 80% powering and you look at that as the as the comparator, and really I don't think it matters [Technical Difficulty] as your comparator as all roads lead to eight months, it seems that you're really talking about a trial of somewhere in the neighborhood of 100 to 150 patients. We've had discussions with the FDA about using real world control data. Actually, a real world control Phase 3 design has been approved by the FDA. And if that we're able to do that, that'll mean the active patients are going to be much closer to maybe 100 patients to get that same level of powering, such that we would have a randomization scheme that sort of looks like this. You would treat three active patients, would be compared to three control patients. And of those three control patients, two would be demographically matched real-world control patients, and one would be a true comparator, prospectively taken, and that would likely be either a comparator to bevacizumab or a radiation or standard of care, which is essentially a physician's choice. Does that answer your question?

Yes, it does. Thank you so much for answering my questions, and I just want to say congratulations on the progress in the quarter.

Thank you. Thanks, Lindsay.

Thank you. One moment for our next question. And that will come from the line of Sean Lee with H.C. Wainwright. Your line is open.

Hi. Good afternoon, guys, and thanks for taking my questions. My first one is on the LM study. So you proposed a dose expansion at the 44 millicure dose. I was wondering, is that going to be another additional cohort to the Phase 1 study? Or would that -- you may seem that as part of the Phase 2 study that you were planning?

Hey, Sean, thanks for the question. Yeah, so let me tell you what my aspiration with that is. And it's subject to discussion with FDA. And it's subject to their desire to move this program quickly. I think the ideal path here would be for the FDA to sign-off on a Phase 2 trial with focused on breast cancer, likely HER2 positive and HER2 negative patients, [indiscernible] equals 15 of each at the 44 millicuries. So the Phase 1 dose is a basket trial, includes lung patients and breast patients, gastrointestinal cancer patients, and so forth. So the key in segmenting the patients by molecular subtype is to the degree that overall survival is in the endpoint mix, there likely will be a differential survival depending on what kinds of patients one selects based on survival data that's been reported in patients with LM. So I think we want to sort that out. But from a statistical evaluation, this discussion with FDA, I think, will elicit the proper endpoints. Our belief is that while overall survival is important and the ultimate goal, because these patients have essentially two cancers, a primary cancer in the breast and a metastatic cancer, that confounds the interpretation of overall survival data. Our view is that actually CNSide is the best measure of response and correlates with survival and that could be an important primary endpoint -- co-primary endpoint, or secondary endpoint. That would change the trial design dramatically. So my anticipation is if that's the way we go with the Phase 2 with 30 patients, 15 of each hormonal subtype, we could analyze those individually and also collectively that could provide enough patients ideally we could build this in upfront to roll directly into an approval trial. So that would be ideal. That will take a little bit more negotiation with the FDA and likely a bit more time to get up and running. We could also do a Phase 1b, which is essentially a direct dose expansion. That would be quicker, but it likely would not expedite the regulatory approval process as much as going directly into kind of a Phase 2 or a Phase 2/3 pivotal design.

Just thanks for that. With regards to the multi-dose study then, would you wait for the first data to come out from that study before you initiate a Phase 2, or would you try to build that into a Phase 2, or would that, for example, need a second study afterwards?

Yeah, no, I think we're going to move forward directly into this Phase 2 or Phase 1b. That data will be important no matter what we do in terms of increasing the [Technical Difficulty] performance data. The proper endpoints in trial, powering assumptions and expanding the PK/PD data. So that -- no matter what we do with multiple doses, that's going to be important data to drive the overall program. I think the Phase 1 data is very promising. We've had multiple multi-year survivors, which is essentially unheard of. If you look at the survival Kaplan-Meier curve for median overall survival, you see a lot of long-tail survival, which is unheard of in the disease, which is a very positive thing. So, I do believe, based on the data, that proceeding with a single dose approval is very promising and possible, and I think we should pursue it as quickly as we can. But either way, we win with that data set. The multiple dose data, I think we already know that multiple doses work. We've treated patients in the Phase 1, as you know, Sean, with multiple doses under compassionate use. We know on a small number of patients that we could do that safely at very high doses and patients seem to live longer. Dose optimization can take a while, So we think it's very important to get this into the market, two patients, two doctors, as quickly as we can. We think that pathway really goes through single dose first, and then we'll layer on dose optimization as the data comes back. And then play read and react to the data in consultation with the FDA.

Okay, great, understood. And now my final question is on the CNSide. I was wondering if you could provide a bit of color on the market opportunity and how much, where do you think you'd be the next 12 months or so?

Yeah, it's a great question. In my view, the market opportunity in kind of a best reasonable case, is 0.5 million tests a year in the US. And that leverages ruling in the diagnosis, ruling out the diagnosis in patients that might have breast cancer and suspicious neurological symptoms but indeed don't have LM. And then the treatment monitoring data increasingly looks to be very promising. So, you add up all those markets and you look at the publications that are increasingly coming out showing there's an epidemic in LM really drives that market number. So it's a very sizable market opportunity in our view. And the prior companies' commercial data over 2.5 years really support the physician acceptance of that. About half the major cancer centers in the US were using the test during that time frame. So I think it's a very sizable market opportunity. Where do I think we'll be a year from now? I think that the tumor cell enumeration test will be commercial. It will be rolled out on a geographic scale as we get state licenses and we get major payers on board, as well as Medicare. We've actually made great progress in the last nine months on those. We'll be able to talk about that more. But we want to talk about those on a success basis, not on a forward-looking basis. So I think we have the ability to scale up operationally in Houston, really to infinite tests. So the number I mentioned before, 0.5 million tests, we can do that in our Houston facility. Scale-up is really a matter of extra headcount and extra capital equipment. The devices involved in the tests we actually make in Houston. So we control our destiny there. So I think, a year from now will be the TCE test will be expanding throughout the US. We'll be adding in situ hybridization, immunocytochemistry and NGS along with that. We'll be rolling out later in the year. And we'll be building out a sales team that will be focused, as I addressed Ed's question before, on those major cancer centers and those physicians that are key opinion leading doctors. And I failed to mention Russ Bradley. Russ has been there, done this multiple times throughout a 25, 30 year career in diagnostics, including a long stint at Abbott. Knows how to scale diagnostics and has key relationships in the market and can do this operation commercially. So really be integrating him more and more in that business over that same time frame.

Thank you for the additional details. That was very helpful. And thanks again for taking my questions.

Thanks, Sean.

Thank you. I'm showing no further questions in the queue at this time. I would now like to turn the call back over to Dr. Marc Hedrick for any closing remarks.

Thank you, Sherry. Thanks to everybody that joined us on the call, listening on the call in the recorded version. I'd just like to say on behalf of the Board, I'd like to thank our employees, our team members, the physicians that we work with, the key opinion leading doctors that are in this area that, I really appreciate their input and then most of all the patients that that trust us a number of which I've talked to and interfaced with them as they've been involved in our trial. Thank you very much for your participation on the call and have a good evening. Goodbye.

This concludes today's program. Thank you all for participating. You may now disconnect.