Good day and welcome to the Plus Therapeutics January 22nd, 2026, Business Update Conference Call. All participants will be in listen-only mode. Should you need assistance, please signal a conference specialist by pressing the star key followed by zero. After today's presentation, there will be an opportunity to ask questions. To ask a question, you may press star then one on a touch-tone phone. To withdraw your question, please press star then two. Please note that this event is being recorded. I would now like to turn the conference over to Vivian Cervantes, Core Investor Relations. Please go ahead.
Thank you, Chloe. Good morning, and thank you for participating in today's conference call. Earlier this morning, the company released a business update and outline of progress in its RIOVA clinical program and CNSide U.S. commercialization. A copy of that press release can be found on the company's website at plustherapeutics.com under the Investors tab. In addition, the company's latest corporate presentation was also filed with the SEC in an AP filing and posted in the IR section of the company's website. Joining me on today's call are Mark Hedrick, Chief Executive Officer, and Andrew Sim, Chief Financial Officer. During the call, management will be making forward-looking statements, including statements that address Plus Therapeutics' expectations for future performance or operational results. Forward-looking statements involve risks and other factors that may cause actual results to differ materially from those statements.
For more information about these risks, please refer to the risk factors described in Plus Therapeutics' most recently filed annual report on Form 10-K and subsequent periodic reports filed with the SEC, and the press release that accompanies this call, particularly the cautionary statements within. The contents of this call contain time-sensitive information that is accurate only as of today, January 22, 2026. As a statement required by law, Plus Therapeutics disclaims any obligation to publicly update or revise any information to reflect events or circumstances that occur after this call. It is now my pleasure to turn the call over to Mark.
Thank you, Vivian. Good morning, everyone. Thanks for joining us on our call today. Today, we plan to provide you with a business update highlighting recent progress with our RIOVA clinical program and CNSIDE U.S. commercial activities, and also provide guidance for 2026. I'd like to begin by providing color on our recently completed financial offering. On January 14th, we announced the pricing of a $15 million offering that was oversubscribed and ultimately upsized. The transaction allows us to welcome new customers who are as excited as we are for the year ahead. Besides providing the company with growth capital that extends our runway through 2027, it allows us specifically to, one, expand investments in our CNSIDE business such that it can be break-even by 2027, and two, complete our two ongoing phase II RIOVA clinical trials and position both programs for pivotal trial readiness early next year.
Let me lead off with some thoughts on our REYOBIQ clinical program. In November 2025, following a very constructive End-of-phase Type B meeting with the FDA, we received feedback that will speed up our ReSPECT-LM clinical development timelines. Our goal for this meeting was to align with the agency in as much detail as is possible on a pivotal trial design. As LM represents a significant unmet medical need with no FDA-approved drugs, we wanted to make sure our ongoing phase I-II trial incorporates current agency thinking and experience on LM. Our questions focus specifically on accelerated approval, trial endpoints, and key trial design considerations. As always, these matters are subject to final agency agreement, but we reached general agreement on a randomized pivotal clinical trial design, including potential primary endpoints and comparators.
As to endpoints, the agency encouraged us to consider improvements in neurologic condition and patient-reported outcomes, as well as overall survival for future marketing approval. This was a big win for us. They also encouraged the use of CNSIDE as an important secondary endpoint, also a win. In terms of trial design, we agreed that intrathecal chemotherapy was an appropriate control comparator and that we should control for both the need for focal radiation in certain circumstances and systemic chemotherapy in both arms. Bottom line, I was extremely pleased with the call and the clarity we gained. We will make several amendments to our clinical trial design such that we gather additional data that should de-risk the pivotal trial based on the FDA feedback.
In 2026, our goal is to obtain one or perhaps two optimal RIOVA dosing regimes, then move those directly into an approximate 12-patient dose expansion arms to gather additional safety and efficacy data to form the basis of a pivotal trial. We are making good progress in enrollment and will be expanding sites in 2026 with the updated protocol and anticipate reporting data in Q3 2026. Regarding our recurrent GBM or recurrent glioblastoma clinical trial, we are on track to complete enrollment in phase II this year with data expected in Q4 2026. The pediatric brain cancer trial should begin enrolling soon at Lurie Children's Hospital in Chicago. Based on the anticipated need to be pivotal trial ready by the end of Q4 this year, which is our goal, we will be scaling up RIOVA drug manufacturing in 2026 to meet that year-end milestone.
Now, let me shift over to CNSIDE commercialization. Again, commercial testing operations in our CLIA-certified Houston laboratory obtained state licensure now in 49 of 50 U.S. states, having most recently added Pennsylvania to the mix, and announced agreements with UnitedHealthcare and Humana for a total of 67 million U.S. lives covered. In 2026, our focus will be on commercial scale-up. Key milestones for the year include reaching over 150 million covered lives through additional payer agreements, many of which are in ongoing negotiations, obtaining Medicare and Medicaid coverage, ramping testing utilization to at least reestablish the prior commercial run rates of 1,250 tests per year, establishing a 50 or more unique ordering physician customer base in 2026, and over time, we plan to reach as many of the previous 200 unique ordering physician users as possible and expanding into the broader oncology market.
Finally, expanding the number of independently built test offerings through ongoing R&D efforts. As to guidance, early in our U.S. commercialization, we plan to report quarterly progress via key metrics such as covered lives, tests performed, newly available laboratory tests as a result of our R&D efforts, and other material announcements as they occur. With that, let me now turn the call over to the operator, Chloe, for your questions.
We will now begin the question-and-answer session. To ask a question, you may press star then one on your touch-tone phone. If you're using a speakerphone, please pick up your handset before pressing the keys. If at any time your question has been addressed and you would like to withdraw your question, please press star then two. At this time, we will pause momentarily to assemble our roster. The first question comes from Jason Kolbert with Dawson James Securities. Please go ahead. Jason, is your line muted?
Yes. Sorry about that. Hi, Mark. Thank you so much. You talked about break-even in 2027. How long will the existing cash, including the raise, carry you? And what do you—it seems to me that you have about a year's worth of capital now. Is that about right? And given that, what are you thinking in terms of the stock and how you continue to fund the company?
Thanks, Jason. This is Andrew. As Mark mentioned, the recent raise, together with the ongoing grants that we continue to have access to, I just want to remind the audience that we continue to have access to three grants that continue to fund the three indications in the clinic: CPRIT with LM, NIH for the GBM trial, and then DOD with the pediatric trial that will fund us through 2027, and that will allow us for the full funding of all the milestones Mark laid out.
Sorry, I don't feel like you answered the question.
Maybe you could rephrase it, Jason, so we can be sure we answer it.
If you're talking about break-even by 2027, then based on my model, it's reasonable to assume that you'll spend about $15 million in capital over the next four quarters. You have a year's worth of capital. What are the plans to finance the company, given the fact that you're now trading at - last I looked - around $0.30 a share? Are you thinking about a reverse split? How are you going to manage this? It becomes a critical element to the stock.
Well, I mean, let me just, Jason, so with the recent capital raise and current cash, that gets us through 2027 at our current burn rate. And that will budge up slightly, as Andrew indicated. We still have the grant support. When I said break-even, let me clarify. That's break-even for the CNSIDE business, the positive contribution margin for CNSIDE. We'll still be burning cash, however, at that point on the clinical programs. So that's.
Okay. Hopefully, that helps.
Go ahead.
Yeah. No, that makes sense. And that clarity is very important. Mark, I know you had been kind of toying with the idea a year ago about a reverse stock split. Is that something that you're thinking about now, or is the plan to try to just generate positive catalysts, show that you can commercialize the diagnostic, make clinical progress, and try to drive the stock back up?
Yeah. I think there's no rush to do that. We have another few months before we have to make that decision. So I think there's going to be opportunity for a number of announcements between now and then that can move the stock. We've shown that the stock can move pretty aggressively on good news. We think we have good news ahead of us for 2026. And I think we're in no rush to do anything. So I think we just keep our heads down, execute. This capital really helps us move more quickly than we otherwise would if we think there's a lot of opportunity for the stock to appreciate on its own.
Okay. Terrific. Thanks, Mark.
Thank you, Jason.
The next question comes from Sean Lee with H.C. Wainwright. Please go ahead.
Hey, good morning, guys, and thanks for taking my questions. My first one is on the ongoing ReSPECT-LM dose-finding study. So you mentioned that you would go into a 12-patient expansion arm once you find the optimal dose. Now, my question is, what criteria are you using to determine which dose is the optimal one? Are you primarily looking at safety, or are you looking at response as well?
We'll be looking primarily at response, and obviously, there are safety implications, and we don't have an extensive number of patients at a single-dose cohort to be able to extrapolate to what multiple doses would look like, but because of the dosimetry data we have, specifically around the critical organs like bone marrow, we have a pretty good idea of where we're going to get into potential safety issues, and I think, as hopefully you'll recall, Sean, the doses we are taking into this dose optimization trial are at the lower end of the phase I dose escalation, where we really saw essentially no meaningful safety signals, so we'll be looking at those, but we think we're in a pretty good range even with multiple doses.
And then in terms of looking at response, besides what we looked at previously in the phase I, which is imaging, clinical, and circulating tumor cell response, we'll be looking more specifically at neurologic progression or neurologic improvement, as well as looking at the patient-reported outcomes via the NANO scale. So that will kind of be responsive to what the FDA encouraged us to look at. And then we'll be making a decision in combination on both of those two things, but I really expect most of the decision to be weighted on the biologic performance of the drug in terms of either survival or improving neurologic symptoms or patient-reported outcomes.
Thank you for the clarity and as a quick follow-up to that, does the company plan to provide an update once you've decided on which dose to expand into?
I think, yeah, in terms of the trial, if we get to a point during the year where we have a dose that looks promising and we expand, we'll be updating on that. Otherwise, we're going to just continue to execute on the currently agreed-upon dose escalation scheme that we've agreed to with the FDA, and so as we escalate to new cohorts, I think we'll probably discuss that in various forums, but yeah, once we expand, we'll definitely make that public.
Great. Thank you for that. My next question is on the CNSIDE commercialization. I think in the prepared remarks, you mentioned that obtaining Medicare and Medicaid coverage is one of the key milestones this year. So what exactly are the steps that the company needs to take to get to that point?
I think we need to get a PLA code and then a DEX Z-Code, and we're working on both of those. We're making good progress along the way. I think we're pretty far down the road in that process. I think we feel confident that we can deliver that in 2026. That's going on in parallel to bringing on other payers. As I mentioned, those are going well. It's good that we have two data points that suggest that payers value this test. I think we just see that we're in good shape as it relates to reimbursement. I will say the caveat that just by virtue of the epidemiology of the disease, it tends to be shifted a bit more towards younger patients. Our estimate's about a 60/40 split between private payers and Medicare.
So Medicare is perhaps less important than it otherwise would be. But it's still important in terms of us getting to our goal of 150 million-plus lives.
All right. Got it. Appreciate the clarity on that. My last question is, I think on the prepared remarks, you mentioned that a goal for this year is to establish 50 or more ordering physicians. I think you mentioned the number 200 as well. So I was wondering whether the 200 is the number that previously have ordered CNSIDE before, or is that the number for the core target population for these indications?
Yeah. Let me answer the question specifically and then provide context. So yeah, 50 is our goal, and I think we can exceed that. And that will be our goal to exceed that. But it's early in the process, and I think we want to be a bit more conservative in forecasting and hope to exceed those forecasts. The 200 I mentioned is the number of individual ordering physicians that the prior company had when it was commercial. And to put that in context, there are a bit over 300 neuro-oncologists in the country. So they had a significant number of those super specialists that were ordering the test.
To tie that back to what we had discussed previously, Phase I of commercialization, as we scale up, is really to get into the hands of the neuro-oncology community, which are thought leaders and take care of difficult patients and are on the podium and so forth. But really, as we kind of do our market analysis and think about the next step of commercialization beyond those neuro-oncologists, it's really the need to get into the medical oncology community, the physicians that take care of patients with breast cancer, lung cancer, melanoma that are the primary drivers of LM. And then that will come thereafter. We can broaden beyond that kind of 200 or so goal, which was the prior company's number of ordering physicians. So that's how we sort of see it sort of unrolling over the course of the next couple of years.
Great. Thank you for that. And thanks again for taking my questions. I appreciate it.
Thank you, Sean.
Again, if you have a question, please press star, then one. The next question comes from Ed Woo with Ascendiant Capital. Please go ahead.
Yeah. Congratulations on all the progress. My question is, you said that your goal is to be having more than 1,250 tests per year. Will that allow you to achieve profitability in the CNSIDE business in 2027?
No, so our goal this year, just to be clear, Sean, is to get at least back to the run rate of the company when it was commercial at the end of its commercialization when they quit operations, and that was about 1,250 tests per year of the tumor cell enumeration test, to be specific, which is a component of the platform, so we set that goal for ourselves to really go back and go back to those customers, reintroduce the test, reintroduce ourselves, and that's kind of our—that's sort of our minimum goal for the year, but we think there's opportunity to go well beyond that, but that would not get us to profitability. I think current estimate, just look at tumor cell enumeration as one of the four tests, probably somewhere in the neighborhood of about 5,000 tests.
1,250 gets us maybe a quarter of the way there. We think that would be a really good start to the year. Having a broad-based number of lives that are covered at attractive reimbursement, I think, is the basis upon which we sort of forecast that about 5,000 tests roughly gets us there.
A follow-up question is, is there much operating leverage in the number of tests that you do? Will you be able to gain significant efficiencies and have much greater margins at the 5,000 tests versus the 1,200 tests?
Very significant opportunity to automate the process. In fact, since the prior company licensed the test to us, ultimately, we acquired all the assets and so forth, and now that we're back doing testing, we've already made significant improvements in cost over the prior company, and we can see further reductions that I would say really will impact the economics of the business.
Great. Thanks for answering my questions, and I wish you guys good luck. Thank you.
Thanks, Ed.
This concludes our question-and-answer session. I would like to turn the conference back over to Dr. Mark Hedrick for any closing remarks.
Thank you, Chloe. And thanks for the questions. We are committed to improving survival in CNS cancers. And there has been lack of progress in that over the last four decades. And what we've done as a community really hasn't worked. So our goal is to really upend the playbook by focusing on improving both the diagnostic capabilities with CNSIDE and then bringing a groundbreaking drug like Raiobiq to market. We appreciate the time and interest in the company. And thank you for your support. And we look forward to our next update. Thank you.
The conference has now concluded. Thank you for attending today's presentation. You may now disconnect.