Plus Therapeutics Inc Aktie

Good morning, and welcome to the Plus Therapeutics Midyear 2026 Business Update Conference Call. [Operator Instructions]

Before we begin, we want to advise you that over the course of the call and the 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 those described in Plus Therapeutics' annual report on Form 10-K and quarterly reports on Form 10-Q. Plus Therapeutics advises you to review these risk factors in considering such statements.

In addition, comments made during this conference call contain information that is accurate as of the date of the live broadcast today, June 30, 2026. Plus Therapeutics assumes no responsibility to update or revise any statements to reflect events, trends or circumstances after the date they are made, except as required by law.

It is now my pleasure to turn the call over to Dr. Marc Hedrick, Plus Therapeutics' President and Chief Executive Officer. Dr. Hedrick, you may begin.

Thank you, Betsy. Good morning, and thank you for joining today's call. Let me begin with some important and exciting news. We are pleased to announce that Plus Therapeutics is becoming Cerenome. We will begin trading on NASDAQ under a new ticker CNSY, beginning on August 3. Shareholders do not need to take any action. Their shares will automatically reflect the new company name and ticker once the change becomes effective. This change is the result of more than a year of work and substantial progress across the business.

With REYOBIQ, CNSide Diagnostics and our growing data and AI capabilities, we are building an [Technical Difficulty] oncology platform [Technical Difficulty] therapeutics, diagnostics and proprietary data with a single goal, improving survival in central nervous system cancers.

In simple terms, we are no longer a pure-play radiotherapeutics company, and we needed to align the company name to its identity. The old name described one part of the company. The new name is intended to reflect the company we are building each day and the opportunity ahead of us. Cerenome combines cere referencing the brain with ome meaning the full set of data and biological information we are working to understand. Cerenome, therefore, reflects our focus on central nervous system cancers and on integrating therapy, diagnostics and data.

I've been clear about what is changing, so let me also be clear about what's not changing, and that is the direction of the company. The name change is simply the capstone of the actions management has taken for the past few quarters. The story isn't changing. It's actually continuing to evolve and ramp as the opportunity as we see it expands. Operationally, we intend to work day-to-day as an integrated CNS oncology platform company while maintaining distinct business leaders and mandates between the divisions of therapeutics, diagnostics and data analytics/AI. And you'll be hearing shortly from these leaders on the call today.

The opportunity to combine these disciplines is powerful and the unique requirements of each require a mix of both subject matter expertise married to common elements and a common key cohesive element for us will be our implementation of native artificial intelligence. We feel any added business costs related to the expanded AI opportunity will be more than offset by the native AI efficiencies that we generate and have the compounded commercial opportunity on the table.

So to summarize the new identity and how we are rolling this out. On August 3, we will begin trading on NASDAQ as CNSY. That day, our new corporate website and cerenome.com goes live, alongside a coordinated series of investor, press and social media communications. Then at the SNO ASCO meeting in August, we will bring the full measure of the brand forward commercially to clinicians, partners and the scientific community.

Now before moving to an update for our Therapeutics division and REYOBIQ, I want to formally introduce Dr. Eric Daniels, who joined us as Chief Development Officer this past April. Eric brings more than 2 decades of experience across clinical development, regulatory strategy, corporate operations and business development. Most recently, he served as Chief Development Officer at Kiora Pharmaceuticals, where he oversaw the company's full development portfolio, including clinical, preclinical and CMC activities and work closely with the executive leadership and the Board on strategy and execution.

He brings a strong entrepreneurial background, having co-founded Bayon Therapeutics and previously served as Chief Executive Officer of OccuRx, where he led corporate strategy, clinical development and operations. We believe his combination of strategic, regulatory and operational leadership will be highly valuable as we continue to advance REYOBIQ and further build out our therapeutic pipeline.

With that, I'll turn the call over to Eric to take you through our update for therapeutics. Eric?

Thank you, Marc, and good morning, everyone. As Marc just laid out, I recently joined Cerenome as the Chief Development Officer. With oversight over our therapeutics business, I welcome the opportunity to advance our therapeutic pipeline. Our lead asset, REYOBIQ or rhenium-186 obisbemeda is a precision radiotherapeutic for central nervous system cancers that we are advancing in the treatment of leptomeningeal metastases, recurrent glioblastoma and pediatric malignant gliomas.

I'd like to take this opportunity to review our 2026 objectives and progress for REYOBIQ as follows: objectives [Technical Difficulty] optimal dose interval for REYOBIQ in the ReSPECT-LM Phase II trial with an anticipated interim data readout in the second half of 2026. This objective is in progress and remains on track. The ReSPECT-LM Phase II trial is a multicenter multiple-dose study and a follow-on to our previously reported or released LM single-dose escalation trial.

We expect our optimal dose and interval to be consistent with our previously released trial data and believe this may be achieved with 12 to 18 patients, assuming no dose-limiting toxicities, which we have not observed to date. We've completed 1/3 of this target and with ongoing site expansion, we anticipate reaching a recommended Phase II dose by year-end. Interim data analysis for this trial will be ongoing. We anticipate we will conduct one in Q3 and a trial update abstract has been submitted to the Annual Meeting of the Society for Neuro-Oncology in November of 2026.

Dosimetry data analysis from our single-dose administration study remains ongoing and is expected to be released by year-end. Dosimetry data is an important safety signal as target -- off-target toxicity remains an important facet of radiotherapies. Given its liposomal formulation, REYOBIQ represents an attractive precise approach, and we anticipate the dosimetry data to support this assertion.

Turning now to the pivotal development pathway for REYOBIQ in LM. LM is a lethal CNS compartmentalized complication of primary malignancies, most commonly lung and breast. The rapid deterioration of patients and the limited survival poses challenges to trial design. As previously reported, the FDA provided us valuable feedback during our Type B meeting in November of 2025, and we've been incorporating 2 primary recommendations into a planned protocol amendment.

First, following dose optimization and expansion phase, we plan for the Phase II trial to include a randomization scheme versus intrathecal chemotherapy. Sample sizes and randomization ratios will be confirmed following the expansion phase and are data-dependent. Second, we plan to introduce neurologic function and patient-reported outcomes as key secondary outcomes in support of a marketing application. Trial will position us for either a follow-on registration study or potential accelerated approval. Timing updates for the program will be provided as details emerge on dose optimization and estimated sample sizes.

Objective number 2 is completing enrollment in the ReSPECT-GBM Phase II trial for glioblastoma and conducting an end of Phase II meeting with the FDA with the goal of aligning on trial design -- excuse me, pivotal trial design with data expected in Q4 2026. This objective is also well underway and remains on track. The ReSPECT-GBM Phase II trial is a multicenter, single-dose administration of REYOBIQ administered via convection-enhanced delivery. We've enrolled 31 of the target 34 subjects in this study. We have 3 active enrolling sites throughout the United States and current rates of enrollment put completion on track for 2026. Data readout timing will be dependent upon enrollment, database cleaning and final analysis.

As with REYOBIQ and LM, I'd like to take this opportunity to discuss the pivotal development pathway in GBM. Completion of the current study and following an end of Phase II meeting with the FDA, we believe we would be in a position to move to a registration study. However, as a cancer that's notoriously difficult to treat, this go/no-go decision will be data dependent in order to estimate a pivotal treatment effect, powering and the necessary resources to support the business case. Timing updates on continued enrollment will be provided.

Objective number 3 is to complete commercial manufacturing scale of the REYOBIQ. We're proud to report this objective also remains in progress and on track. Recommendations from our Type C meeting with the FDA regarding purification, qualification and impurity characterization activities have been completed or are on schedule to be completed by the end of the year. Method transfer has been initiated, personnel have been trained, qualification activities are progressing to schedule, and the Q4 audit is planned for our new CDMO by the end of the year. The supply road map has also been completed with the overnight delivery constraint resolved with the new vendor. We believe the manufacturing scale and supply chain of REYOBIQ will readily support the clinical trial and any early commercial activity.

Finally, objective number 4 is to begin enrollment in the ReSPECT-PBC pediatric brain cancer Phase I trial. This objective is in progress and remains on track. We have received both DoD and IRB approval to conduct the study. We've completed contracting with Lurie Children's Hospital at Northwestern and site activation is imminent. First dosing is expected in Q3.

Aside from continued material progress in clinical development in CMC, the therapeutic development team is adopting enterprise-wide AI initiatives aimed at mining data relationships between longitudinal clinical data and the company's CNSide platform. So in summary, our 4 objectives for radiotherapeutics 2026 remain on track with key execution risks rooted in unexpected trial delays or unforeseen CDMO supply challenges. The therapeutics [Technical Difficulty] pivotal-ready status in 2 indications.

Thank you for your time, and I'll hand the call over to Russell to provide an update on our Diagnostics business.

Thank you, Eric. We also have 4 goals for CNSide in 2026, all of which are on track. Let me start with where we stand against each one and then talk you through the supporting information behind the numbers. In January, we introduced these 4 goals, and we affirm them again in March and May. We have not changed them, and we're tracking to each of them.

Goal #1, expand U.S. commercial payer coverage to more than 150 million covered lives. This goal is on track. We entered 2026 with approximately 67 million covered lives from United Healthcare and Humana. As of last Thursday, with the Elevance Health National Coverage Agreement announcement, we contracted -- total contracted coverage for the CNSide CSF Tumor Cell Enumeration assay now stands at approximately 126 million people. That figure reflects new -- 3 new coverage agreements year-to-date, Highmark and Blue Shield of California in April and Elevance Health adding approximately 45.4 million lives effective May 1. We remain on track to deliver the 150 million covered lives goal this year.

Goal #2, secure Medicare coverage pathway. This goal is also on track. On May 7, CNSide Diagnostics enrolled in the Medicare program and received our Provider Transaction Access Number, or PTAN, opening a direct pathway to submit claims to Medicare. PLA Code 0640U, our dedicated AMA biller identifier takes effect tomorrow, July 1. Formal MAC, Medicare Administrative Contractor coverage determinations and Clinical Lab Fee Schedule pricing for Code 060U (sic) [ 0604U ] are the next milestones on that path. Medicaid coverage pathways remain under development.

Goal #3 achieved 1,250 annualized test order run rate by year-end. This goal is tracking to meet or exceed and was second half weighted by design. The first half order activity was deliberately access-led rather than volume-led. Quarter-over-quarter, Q1 to Q2 grew 64%, and June was our highest month on record at 72 tests. That was nearly double May's volume and more than 3x our January volume. Year-to-date through the second quarter, our lab has performed 232 CNSide tests. The second half ramp will be further supported by the access milestones we now have in place, the onboarding waitlist and the approximately 70 aggregate physicians and their staff that have already signed the CNSide provider portal agreement behind today's active orders.

Goal #4, launch additional CSF tumor characterization assays to expand the CNSide platform. This goal is on schedule. We are on schedule for the first additional test launches in Q3 with further CSF characterization assays planned thereafter, launching on a rolling basis. These tests are intended to provide additional cellular, genomic and phenotypic characterization of CSF specimens and captured tumor cells, supporting clinical decision-making and increasing the economic value of every specimen we process. Taken together, the payer access has materially expanded and the Medicare pathway is now open. The order rate is accelerating of an access-led first half and the multi-assay platform is on schedule. That's the headline.

Now let's unpack the detail behind each of those goals. Firstly, access. Three commercial coverage agreements drove the step-up from approximately 67 million covered lives at the start of 2026 to approximately 126 million today. Highmark, effective on April 1, 2026, took us from 67 million covered lives to 75 million covered lives. Blue Shield of California effective April of 2026 took us up from 75 million to 81 million covered lives. And last week's announcement, Elevance Health effective on May 1, 2026, of approximately 45.4 million lives added from 81 million took us up to 126 million covered lives.

Each of these agreements removes friction at the medical centers where our tests are ordered. In parallel, two infrastructure milestones changed the economics. Firstly, PLA Code 0640U, our dedicated AMA billing identifier, takes effect tomorrow, July 1. This gives CNSide assay-specific reimbursement and simpler, more reliable billing under a single standardized CPT code. Medicare enrollment and PTAN completed on May 7, 2026, opens a direct pathway to submit claims to traditional Medicare. MAC coverage determinations and clinical fee schedule pricing for Code 060U (sic) [ 0604U ] are the next milestones along that path. Taken together, this is the most consequential access progress that CNSide has made since launch.

Now we'll cover adoption. We told you in January that the simple way to track CNSide in 2026, very early in its commercial launch is by payer milestones and order rate with revenue as a trailing indicator. Here is more detail on the ordering. In Q1, we had 88 tests ordered; in Q2, 144 tests. That's up 64% quarter-over-quarter. June was our highest month on record at 72 tests, up 95% over May and over 3x our January volume. Year-to-date through the second quarter, 232 CNSide tests have been performed and our unique ordering physicians have grown from 13 in January to 34 in June, almost tripling in 6 months.

Account breadth is the leading indicator that converts to testing volume and with the PLA Code, Medicare enrollment and 4 national payers now in place, this converts to reimbursable revenue. That account breadth, combined with the June order rate that is prior monthly high is what gives us confidence in our second half 2026 acceleration. Q2 was a breakthrough quarter for CNSide [Technical Difficulty] specifically, 17 physicians placed their first-ever order in Q2, and the repeat ordering depth is where the story gets interesting. 10 physicians have now ordered in 3 or more distinct months, and these are amongst the most respected neuro-oncology centers in the United States. They are not piloting CNSide, they are integrating it into clinical practice.

Today, we have approximately 34 physicians actively ordering CNSide, behind them 18 institutions already onboarded and able to order and a further 17 institutions, approximately 70 individual end-user portal agreements signed by healthcare providers and their staff. Our Early Access Program, which we initiated in Q1 this year, is converting into commercial demand at the very same centers we want to anchor the platform. This is the build phase, leveraging only a modest sized in-house marketing and customer service team. It is working as designed. CNSide -- and then we'll go through the platform.

CNSide is not a single test business. In Q3 of this year, we plan to begin offering additional CSF characterization tests to our physician partners, consistent with our 2026 goal of launching more CSF tumor characterization assays to expand the CNSide platform. These provide additional cellular, genomic and phenotypic characterization of CSF specimens and captured tumor cells, supporting clinical decision-making by the treating physicians and increasing the economic value of every CSF specimen we process.

The Ephemeral partnership announced earlier this quarter is becoming the operational backbone for this expansion, automating lab workflow and data analysis so we can scale both the number of assays we offer and the volume of tests we run without scaling the cost proportionally. Strategically, CNSide is positioned as both an independent component of sales growth and an enabler of REYOBIQ, supporting patient identification, treatment monitoring, longitudinal disease management and clinical and operational data generation across the Cerenome platform.

Looking forward in the second half of 2026, first, we will continue to focus on staying on track with the 4 key business metrics I reviewed earlier. In addition, we plan to further build out a national sales team to accelerate test growth while focusing on our native AI backbone and related laboratory technology and process improvements to minimize cost and speed the delivery of results to healthcare providers and the patients they serve. In short, CNSide is becoming the covered data-rich CSF oncology franchise we described in January, and it is becoming a more strategic asset to Cerenome every quarter.

With that, I'll turn the call back to Marc.

Thank you, Russell. Now I'd like to take a few moments to lay out in broad strokes our data analytics and artificial intelligence strategy, which is, as you've heard, an increasingly important part of how we think about the company's long-term value. We are building AI into Cerenome natively from the ground up. We're not buying a tool and bolting it on. That is a distinction that matters very much. A native AI system as opposed to a bolt-on approach. It is a de novo build-out that's informed specifically by the company's unique data, workflows and nomenclature defined by us and only for us.

In contrast, even frontier AI models will likely become a low-cost utility in the future. Anyone can rent them and the broad data sets upon which they are trained are public. That means the models themselves are not where the durable value is created. Our view is that the durable AI value will be created in 2 key areas: #1, proprietary workflows unique to our business, continually optimized and scaled. And then #2, distinctive data sets that are proprietary to us, essentially what Cerenome generates in our business, but intelligently analyzed. Native AI is uniquely able to create value with what we call ROD or return on data.

In our case, our CNSide business and our clinical trials are anticipated to produce petabytes of unique multimodal data sets tied to real patient outcomes often generated at or near the point of care. That quality of unique data cannot be scraped or bought. In our industry, proprietary data is the ultimate currency. In terms of how we build out that capability, most recently, in May, we signed an agreement with Ephemeral Technologies as our build and implementation partner for key components of the native AI backbone.

The Ephemeral founders led Palantir's healthcare business prior to starting Ephemeral. That relationship is progressing on schedule, and we are optimistic it will provide measurable and reportable shareholder value in the near term and support our ultimate vision of improving survival in central nervous system cancer patients.

Initially, the primary value will be in creating internal efficiencies that reduce costs, improve workflows and speed execution. Building on that native system, machine learning of our proprietary data sets in neuro-oncology, we believe, will lead to unique disease insights, pipeline expansion, improve patient outcomes and ultimately enhance stockholder value. While native AI can impact almost all areas of the company, importantly, high-risk and sensitive areas such as financial and legal operations will remain with proven partners with defined guardrails using compatible systems such as NetSuite and Oracle.

So before I open the call to questions, I want to just reiterate quickly our 2026 anticipated milestones.

First, on REYOBIQ. We [Technical Difficulty] dose interval for REYOBIQ in the ReSPECT-LM Phase II trial and anticipate reporting interim data in the second half of 2026. Number two, completing enrollment in the ReSPECT-GBM Phase II trial for glioblastoma, and we anticipate reporting data in Q4 2026, which is dependent, of course, on continued trial progress. Number three, complete clinical and commercial manufacturing scale-up for REYOBIQ, and number four, begin enrollment in the ReSPECT pediatric brain cancer trial this year. And for CNSide platform, we continue to seek to expand the U.S. commercial payer coverage to more than 150 million covered lives by the end of the year. We'll continue to expand Medicare coverage on a state-by-state basis. We intend to meet or exceed the 1,250 test run rate objective by year-end. And four, expand the CNSide platform to include additional CNS tumor characterization tests.

And with that now, Betsy, I'll turn the call back over to you for questions.

[Operator Instructions] The first question today comes from Sean Lee with H.C. Wainwright.

My first one is on the reimbursement for CNSide. I think in the prepared remarks, I think you mentioned that the next steps for Medicare coverage are getting the MAC approvals as well as the CLFS pricing. So what's the expected time line for these events? And what's the price point that you believe is reasonable?

Yes. Sean, this is Russell Bradley. Yes. So, we have applied under the Medicare Clinical Lab Fee Schedule, and we submitted and had a hearing last month on that. The time frame is that they published initially in about 30 days. There's a public comment period between now and the rest of 2026. And then the final determinations of gap fill or crosswalk are published effective at the end of 2026, effective January 1, 2027.

So we're in the process of understanding how Medicare is going to -- or CMS (sic) [ CLFS ] is going to address our application. So we're expecting through the rest of this year to continue to be active in that process and determine whether or not we'll be crosswalked or gap filled. And then that pricing, if it's crosswalked, will become effective January 1, 2027. The rate -- the different rates we have out there between the private payers obviously is not disclosed. We're applying for a rate that is crosswalked to an existing PLA Code. And I can tell you it's a 3-digit number between $2,000 and $3,000 is what we're looking for crosswalk. That's for me.

Got it. That's very helpful. I just have one additional question on CNSide. You mentioned that you're launching 3 additional test families in Q3. So what does the test launches include? And what -- once these tests are on the market, would they generate incremental reimbursement? Or do they need separate billing codes as well?

Yes. So Sean, the additional testing includes some of the characterization assays. We talked about protein expression and phenotypic testing for making clinical decisions around treatment of the patients. It also includes genomic -- a family of genomic tests that include things like Fluorescence In Situ Hybridization or FISH testing. And we also are planning to partner for a next-gen sequencing offering. So between those, very comprehensive characterization of CSF samples, cellular genomic and phenotypic assessment, some of these are already established tests that have existing CPT codes. So the reimbursement path should be relatively straightforward in those cases. They are all incremental.

So when I talk about the economics changing for CNSide once we run these additional tests, that's what I'm referring to is that we will establish a reimbursement for Medicare and also for the private payers for CNSide, the tumor cell enumeration assay, these additional assays will all be reimbursed separately. The aggregate will be a higher reimbursement for specimen.

[Operator Instructions] The next question comes from Ed Woo with Ascendiant Capital.

Congratulations, Marc, on all the progress that you're doing. My question is on the AI initiatives. How quickly do you think you'll be able to commercialize those AI initiatives? And is it going to require significant capital investment?

Ed, the way I would think about the question is along two fronts. And so initially, the economic impact, and I'll use that term here instead of commercialization, economic impact to the company will be reduction in the number of employees we hire, so reduction in labor cost. And I don't mean by necessarily reducing our current staff, but we'll be able to grow, as Russell Bradley said, in a disproportionate way, where we'll be able to do more with a smaller team as the AI and ultimately, the robotic technology that will be bolted-on to the -- and bolted into part of the AI will begin to unlock that value.

So it will be really on the cost side of the financials that we'll see that impact first. In parallel, the amount of data reporting that we get will be much more efficient. It will be real-time data, the kind of data that you get with a much bigger company in terms of kind of daily readouts of important key performance indicators that will influence corporate decision-making on a real-time basis. So we sort of view those as sort of internal products, if you will.

The second part of that is where the potential impact will be more outward facing and more -- you mentioned the word commercialization. So things like calculations for doctors of minimal residual disease or better algorithms to improve the dosing and delivery of REYOBIQ are things that we will glean through advanced data analytics, looking at both the combination of the clinical and the diagnostic data in parallel in the same patient essentially will allow us to make every patient, its own clinical trial and learn very quickly as to how we can create value downstream in the product offerings we do by pricing-level improvements or bring additional data-driven products to the market that will enhance outcomes and improve survival in CNS patients.

Now you mentioned how much is it going to cost. So really, it's quite economic. I think if we were a bigger company and we had a high switching costs based on prior systems that were non-native AI-driven, the switching cost could be very high, and we'd have a lot of sunk costs based on previous systems we put in place. We're now just ramping commercially on CNSide, and there's an opportunity to build in a system on a native basis with arguably the top provider in the world. So the costs are relatively minor. They'll be even with our budget constraints and the capital requirements will be easily manageable over the next 3 years.

The next question comes from Michael Okunewitch with Maxim Group.

Congrats on a real interesting update here. I wanted to see if you could talk just a little bit about the potential for the size and the scope of an upcoming pivotal trial in LM. And then what role CNSide could play in a potential future study? Could this be an opportunity that you could use to support your development and reimbursement for those additional data tools you plan to develop for CNSide such as the upcoming launch in the third quarter of this year? Any additional color on that would be appreciated.

Michael, this is Eric. For what the size could be of a potential pivotal study in LM, you're looking at likely somewhere in the order of 100 to 200 patients is what we believe or would estimate a registration study would be able to be needed in order to support what is the standard today, which is if you used overall survival as an endpoint, I'm not suggesting we are ultimately, you're looking at having to beat 5 months as a median overall survival.

The second question as to integrating CNSide, we integrate CNSide into every single aspect of our clinical program. We do not run any clinical study without CNSide. And as Russell alluded to, as the molecular characterization and continues to expand, we will just bolt on all of that information into every single clinical study that we do. What that allows us to do is build the supporting data for CNSide as a longitudinal tool to be able to measure the clinical impact of what will be REYOBIQ as the therapeutic. So they really do go hand in glove and complement each other and look forward to just continuing to integrate CNSide into every single clinical study that we do.

I appreciate that. And then I just wanted to ask a little bit on the AI tool. If you could provide a bit more on what that could look like just because AI can go in so many different directions. So would this be -- I want to understand how this would be focused and how it might be implemented. Could that be for improving the diagnostic and prognostic characteristics of CNSide, unlocking additional markers and data insights? Just any additional color you can provide on how the AI tool might be implemented?

Yes, Michael, thanks. So I think to some degree what our intentions are, we -- for competitive purposes, I think we want to be a little bit careful about. But I think I would refer you back to my question, I'll kind of restate it a bit differently but the initial tools will be very operationally focused. For example, CNSide, when it's fully launched in its broadest possible range with 4 types of tests with a growing number of particular specific assays that are going to be responsive to what the market wants and needs, it creates a tremendous supply chain and operational load on the testing and to be able to turn tests very quickly for these patients is very important because these patients, once they get, for example, LM or CNS cancers can deteriorate very rapidly.

So what it allows us to do is manage those complex supply chains and then ultimately, the robotic entities that will accomplish the test to a great degree in a way that creates a lot of efficiencies where rather than hiring a team to do a particular aspect, you can have one person overseeing their AI tools that can oversee the accomplishment of the same task in a shorter period of time at equivalent or greater quality. So we're implementing that today. And so those are things that we'll -- I think we'll see -- begin to see the fruits of later this year, early next year. And our goal is to be able to talk about those impacts when we talk about return on data, what does that look like?

And then kind of in parallel to that, clinical trial operations, there are a number of solutions that are bolt-on or they're provided by consultants to be able to try to automate key parts of what is ultimately a very clunky process. Clinical trial operations is incredibly clunky. And so to be able to operationalize that, use those AI tools to streamline those operations, take things that are highly headcount-dependent and make them automated and trackable on a daily basis is unique to AI in our view. And also, these tools are learning in the background. So back to the original question. So the initial improvements will be really around efficiency and keeping cost on -- keeping a cap on cost and ramping but disproportionately such that costs remain low while we continue to grow the top line.

And then I think finally, just to the last part of your question. So the pipeline will be generated, in our view, ultimately in large part by what we learn from our data analytics tools. So we are going to have, as I mentioned, petabytes of data. That data will reside in part on CNSide and what we learn cellularly, molecularly, phenotypically, genomically about tumors in the CSF will have a biobank related to the patients that we run our diagnostics on and have access to that data. And then our CNS oncology therapy is very, very much bound to the imaging that comes from those patients. That's how we assess in part where these patients have cancer and whether the cancer is getting worse or not and how it's progressing. That's a tremendous amount of data. So being able to meld those data sets together with the scalar data that we get from patient outcomes and so forth, we think is very powerful from a pipeline development perspective. So that's how we plan to put those together. And again, I think with that particular area, I think we'll start to begin to see that maybe next year.

This concludes our question-and-answer session. I would like to turn the conference back over for any closing remarks.

Just to close, I want to thank everybody for joining us on the call today. We appreciate your interest in the company. We're very excited about what we're doing, as you can tell. We're very grateful as we do this to remember and thank our employees and physicians and [Technical Difficulty]. And we're constantly thinking about the patient, and we're grateful for those patients who enter into our trials and trust the CNSide test data for their healthcare decisions with their provider. And we look forward on a quarterly basis to updating everyone as we move forward and of course, appreciate all of our stockholders for their continued support and confidence. Good day.

The conference has now concluded. Thank you for attending today's presentation. You may now disconnect.

Good day, and welcome to the Plus Therapeutics January 22, 2026, Business Update Conference Call. [Operator Instructions] 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 REYOBIQ 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 8-K filing and posted in the IR section of the company's website. Joining me on today's call are Marc Hedrick, Chief Executive Officer; and Andrew Sims, 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 8-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 contains time-sensitive information that is accurate only as of today, January 22, 2026. And except as 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 Marc.

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 REYOBIQ 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 14, we announced the pricing of a $15 million offering that was oversubscribed and ultimately upsized. The transaction allows us to welcome new [Technical Difficulty] 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 breakeven by 2027; and two, complete our 2 ongoing Phase II REYOBIQ clinical trials and position both programs for pivotal trial readiness early next year.

So 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 time lines. 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 derisk the pivotal trial based on the FDA feedback.

In 2026, our goal is to obtain 1 or perhaps 2 optimal REYOBIQ 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 we'll 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 REYOBIQ drug manufacturing in 2026 to meet that year-end milestone.

Now let me shift over to CNSide commercialization. We began 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 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 offering -- 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. And 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 test 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.

[Operator Instructions] The first question comes from Jason Kolbert with D. Boral Capital.

You talked about breakeven 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. So as Marc 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 3 grants that continue to fund the 3 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 Marc laid out.

Sorry, I don't feel like you answered the question.

Well, maybe you could rephrase it, Jason, so we can be sure we answer it.

So if you're talking about breakeven by 2027, and based on my model, it's reasonable to assume that you'll spend about $15 million in capital over the next 4 quarters, you have a year's worth of capital. So what are the plans to finance the company given the fact that you're now trading at -- last I looked at 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, on -- so with the recent capital raise and current cash, that gets us through 2027 so -- at our current burn rate. And that will budge up slightly as Andrew indicated, we still have the grant support. When I said breakeven, let me clarify. That's breakeven for the CNSide business. So positive contribution margin for CNSide. We'll still be burning cash, however, at that point on the clinical programs. So that -- hopefully, that helps.

Yes. No, that makes sense, and that clarity is very important. Marc, I know you have 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 so that you can commercialize the diagnostic, make clinical progress and try to drive the stock back up?

Yes. I think there's no rush to do that. We're still -- 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 could 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 have. We think there's a lot of opportunity for the stock to appreciate on its own.

The next question comes from Sean Lee with H.C. Wainwright.

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, but -- 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 what -- 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, we'll -- but 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 EANO scale.

So that will kind of be responsive to what the FDA encourages us to look at. And then we'll be making a decision in combination on both of those 2 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.

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?

Well, I think -- yes, 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 the new cohorts, I think we'll probably discuss that in various forums. But yes, once we expand, we'll definitely make that public.

Great. 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 before to get to that point?

Well, 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. So I think we feel confident that we can deliver that in 2026. And that's going on in parallel to bringing on other payers. As I mentioned, those are going well.

It's good that we have 2 data points that suggest that payers value this test. And so 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. So our estimate is 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. I appreciate the clarity on that. And my last question is, I think on the prepared remarks, you mentioned that the 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 are the -- is the number that previously have ordered CNSide before? Or is that a number that -- for the core target population for these indications?

Yes. Let me answer the question specifically and then provide context. So yes, 50 is our goal, and I think we can exceed that, and that will be our goal to exceed that. But that's -- 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. And 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 could 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.

[Operator Instructions] the next question comes from Edward Woo with Ascendiant Capital.

Yes. 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 (sic) [ Edward ], is to get at least back to the run rate of the company when it was commercial at the end of the commercial -- 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 the current estimate, just look at tumor cell enumeration as 1 of the 4 tests, probably somewhere in the neighborhood of about 5,000 tests. So that 1,250 gets us maybe 1/4 of the way there. We think that would be a really good start to the year. And then having broad-based number of lives that are covered at attractive reimbursement, I think is the basis upon which we sort of forecasted 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 margin 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 and 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.

This concludes our question-and-answer session. I would like to turn the conference back over to Dr. Marc 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 4 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 REYOBIQ 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.