Plus Therapeutics, Inc. (PSTV) Earnings Call Transcript & Summary

Good morning, ladies and gentlemen. Welcome to the Plus Therapeutics Investor Conference Call. Before we begin, we want to advise you that over the course of the call and question-and-answer session, forward-looking statements will be made regarding events, trends, business prospects and financial performance, which may affect Plus Therapeutics' future operating results and financial position. All such statements are subject to risks and uncertainties, including the risks and uncertainties described under the Risk Factors section included in Plus Therapeutics' annual report on Form 10-K and quarterly reports on Form 10-Q filed with the Securities and Exchange Commission from time to time. Plus Therapeutics advises you to review these risk factors in considering such statements. Plus Therapeutics assumes no responsibility to update or revise any forward-looking statements to reflect events trends or circumstances after the date they are made. It is now my pleasure to turn the floor over to Dr. Marc Hedrick, Plus Therapeutics' President and Chief Executive Officer. Sir, you may begin.

Good morning, everyone. Thank you, Cherie, and thank you for joining us today. The purpose of this call is to provide details of our recent acquisition of the cerebrospinal fluid testing assets from our former partner, Biocept, that was reported last evening. Specifically, we will discuss, first, the relevant background leading to the acquisition and the rationale for it; second, an overview of the assets acquired; three, key progress we have made since our September 2023 sublicense of the CNSide test for LM testing in our ReSPECT-LM; and finally, an overview of how we intend to leverage the acquired assets in our planned near-term milestones. First, I think some context around this is important. The current diagnostic methods for leptomeningeal metastases are very unreliable, even with the combined use of clinical findings, MRI and traditional CSF analyses such as cytology, protein and glucose, the overall diagnostic accuracy in the clinic today is poor. And as a result, published autopsy studies suggest that LM is 2x to 4x underdiagnosed. We believe that the data shows that the CNSide technology is a breakthrough in improving LM diagnostic accuracy, meaning more patients can avail themselves of treatment, tracking disease progression and assessing treatment efficacy. As to the history of our involvement with the CNSide technology and the rationale for our acquisition, in Q2 2022, in planning for our ReSPECT-LM trial, we were exploring the market, seeking trial endpoint or something that we can incorporate as an exploratory endpoint in the trial. We became interested in the CNSide test as the only one out there. And based on early data, and in June 2022, we contracted with Biocept to use it in our ReSPECT Phase I LM trial using a Rhenium-186 Obisbemeda radiotherapeutic for LM patients. As the ReSPECT trial progressed, we became increasingly impressed with the clinical performance and in fact, at the most recent Society for Neuro-Oncology Meeting, we presented our initial CNSide cell enumeration data for ReSPECT-LM, showing a mean tumor cell reduction of 53% in the first 3 cohorts correlated with the outcome. However, last year, we learned that the test developer, Biocept, was facing financial difficulties related to a substantial decline in its primary business, which was COVID testing. At that point, we took a variety of proactive measures to safeguard access to the test, specifically for our ReSPECT-LM trial. These actions included the September 2023 sublicense, which protected our downside risk by allowing us nonexclusive access to the test, immediate access to the testing intellectual property and know-how, leveraging our existing $17.8 million CPRIT grant to help pay for it, and optionality on limited exclusivity going forward. Since the September 2023 sublicense, we have conducted substantial additional diligence on the CNSide assets to fully assess the broader commercial opportunity for CNSide. This included KOL interviews, market analysis, technical analysis, analysis of reimbursement in COGS and other RA/QA and business matters. As our analysis evolved, we developed a very high conviction that the test is not only strategic to our therapeutic business objectives, i.e., it increases the total addressable market for our LM therapeutic by 2x to 4x, but it also offers a synergistic near-term and transformational stand-alone opportunity for Plus. Put simply, we see a near-term value creation opportunity, accelerating our journey towards achieving overall positive corporate cash flow, and we'll discuss more about the next steps in a few minutes. But first, let me explain the assets that were acquired as part of this reported transaction. Big picture, for approximately $400,000, we exclusively acquired all necessary assets to commercially provide CSF testing for 3 types of tests. First, and most important, cancer cell enumeration testing, also known as CTCs or circulating tumor cells, to quantitate adenocarcinoma and melanoma tumor cells in the CSF, and we call that CSF-01. Second, the fluorescence in situ hybridization or FISH testing to determine cancer-specific gene expression to guide therapeutic selection, which we call CSF-02. And third, next-generation sequencing of cell-free DNA, which we call CSF-03. Related additional assets as part of the transaction include: the finished FORESEE clinical trial data set for the CNSide test validation; all intellectual property and the patent portfolio; all related SOPs, rights to all clinical and scientific data; testing consumables; testing equipment and software; high-throughput image analysis equipment and technology; commercial data in all brands; customer information, RA and QA filings; and key consulting agreements with former employees. So let me back up a bit. What is the test? CNSide is a laboratory-developed test that can detect tumor cells as well as cell-free DNA for the cerebrospinal fluid, or CSF, of patients with leptomeningeal metastases. At a high level, the CNSide process involves the following steps. First, collection. The physician collects CSF from a patient, generally via LP shunt or Ommaya reservoir. The CSF is then transferred to a collection tube with an essential proprietary preservative that maintains tumor cells and cell-free DNA stability for up to 4 days during shipping. At the laboratory, the sample is separated into a liquid fraction for cell-free DNA analysis and a cell-rich fraction for multi-parametric cell identification using 10 monoclonal antibodies to specific cell surface antigens. The cell-rich fraction is then pumped through a proprietary [indiscernible] and etched microfluidic chamber. Cancer cells are captured in the chamber while the non-cancer cells pass through. Captured cells are stained then with -- in the microfluidic chamber with fluorescent labeled antibodies and are quantitative via microscopy and automated image capture. Fluorescence in situ hybridization or FISH analysis has been performed by incubating the captured cells with labeled probes to therapeutically significant DNA sequences, and positive cells are quantified again via automatic image capture. The liquid fraction is then used for downstream DNA and RNA analysis. Since our September 2023 sublicense and the subsequent dissolution of the test developer, we have been working to acquire the remaining assets from the [ Court-appointed trustee ] in 2024, which is a record. Meanwhile, we've simultaneously been trying to make operational progress as we do our due diligence. We're very excited to provide a first look today on a number of important new developments and ongoing initiatives since that September 2023 sublicense. First, the acquired FORESEE clinical trial data has now been reviewed and has met its primary endpoint. Since this trial is likely unfamiliar to Plus stakeholders, here's the background. The FORESEE trial evaluates CNSide clinical utility in addressing key diagnostic challenges associated with leptomeningeal metastases or LM. The trial was a prospective observational on multisite trial, in which 40 patients were enrolled, with 22 patients with breast cancer and 18 patients with non-small cell lung cancer. The patients were followed at baseline and at 3 follow-up time points using imaging, cytology, clinical evaluation and CNSide testing. All patients enrolled received baseline evaluation. However, complete longitudinal follow-ups at later time points for all patients were truncated because of the sponsor's financial challenges. However, there was sufficient data to make a number of meaningful conclusions from the trial. The key endpoints to the FORESEE trial were, first, the primary endpoint was to determine the impact of CNSide on physician treatment decisions, which is a standard endpoint in the diagnostic space. Secondary endpoints including evaluating the clinical performance of CNSide versus cytology and tumor cell detection, specifically sensitivity, specificity, positive predictive value and negative predictive value, and then evaluating CNSide as a treatment response monitoring tool for LM tumors. In terms of top line data, CNSide met its primary endpoint on physician treatment decisions. CNSide significantly influenced clinical decision-making, aiding in treatment selection in approximately 90% of cases, a minimum of 20% was required to meet the endpoint objective. Now that we own the asset, we are working with the trial CRO, which was Icon, to monitor the full data set. The trial also showed CNSide's clinical performance compared to cytology, showing sensitivity, specificity, PPV and NPV metrics consistent with the published data, and I'll summarize that later in the call. A presentation of the full analysis and presentation of the FORESEE data is planned for the SNO/ASCO meeting in August 2024 and the trial findings are consistent with Plus' clinical experience. And actually my next point. And the second most important development since last September is that 2 peer-reviewed papers on CNSide have been published and another 2 have been formally accepted for publication. In addition, 2 more publications are in draft. Prior to these papers, there have been no peer-reviewed papers on the CNSide technology. In aggregate, these publications collectively show that the CNSide assay can improve the clinical management of leptomeningeal disease. And I think it's important because this is new to our stakeholders -- that we published or accepted publications, 2 of which can be found today on our website, and then the second 2 will be found when they're published. The first publication showed results from a retrospective analysis of 15 unique patients that indicates that the CNSide assay has the potential to improve the management of leptomeningeal disease in advanced non-small cell lung cancer patients. It supplements standard of care methods for diagnosis, monitoring, treatment response and detecting actionable genetic mutations in the CSF. Some findings include, in terms of improved diagnosis, in match samples, CNSide detected tumor cells in 88% of LM-positive samples, exceeding the 40% sensitivity of conventional cytology. In terms of treatment monitoring, in patients where serial CSF samples were analyzed, changes in CSF tumor cell counts correlated with treatment response. In terms of actionable mutations, CNSide detected genetic alterations with possible therapeutic implications in 75% of patients. Now the second publication, this includes results from a retrospective study of 31 patients that shows that the number of circulating tumor cells and CSF as measured by the CNSide assay. The authors conclude that it could be a valuable prognostic tool for patients with LM caused by solid tumors. And some key findings include patients with high numbers of CSF tumor cells demonstrated significantly shorter survival times, an approximately 19 tumor cells was identified for differentiating survival outcomes. In terms of improved sensitivity, in match samples, CNSide detected circulating tumor cells in the CSF in 94% of LM positive patients, outperforming traditional cytology, which detected cells in 55% of the patients. As a prognostic tool, CSF tumor cell numbers can help clinicians better stratify LM patients based on risk and that this information has the potential to guide more personalized treatment decisions. The third retrospective study accepted for publication highlights the potential of the CNSide assay to improve leptomeningeal management. It shows that the assay may offer advantages over standard of care methods for diagnosis, treatment monitoring and identification of actionable mutations. Specifically, some key findings in this third paper include, first of all, improved diagnosis, CNSide detected circulating tumor cells in the CSF in 100% of the LM positive patients, whereas this was 65% for cytology. In addition, for 34% of cytology negative patients CNSide detected tumor cells, a very critical, practical diagnostic point for working at these patients. In terms of CSF specific HER2 status in breast cancer patients. The study revealed that in 35% of patients having a HER2 negative primary tumor, a demonstrated HER2 positivity of the LM tumor as measured by HER2 FISH analysis of the CSF tumor cells, which is our CSF-02 assay. This data shows that accessing the CSF specific information could show genomic differences in the CSF distinct from the primary tumor and open up additional treatment options for disease where limited therapeutic options are available. Again, for this third paper, serial quantification of CSF tumor cells using CNSide may allow better assessment of treatment response and facilitate more informed treatment decisions. Now finally, the last publication. And this has been formally accepted, but not published yet, presents the analytical validation data for the CNSide test in capturing circulating tumor cells in the CSF. It further validates the analytical performance of Plus to cell capture assay designed for detecting circulating tumor cells and also highlights the assay's potential to improve LM disease management, particularly in early diagnosis and treatment monitoring. So as I mentioned, 2 papers are published, 2 are in press and accepted and 2 more are being submitted. Now moving on to the third very positive development is that the use of CSF circulating tumor cells has now been officially recommended in the clinical workup of LM by the most influential oncology clinical body in the world, the National Comprehensive Cancer Network or the NCCN. The NCCN is a non-for-profit alliance of 33 leading cancer centers devoted to patient care, research and education. More specifically, new in the 2023 National Comprehensive Cancer Network clinical practice guidelines in oncology, the guidelines note that the CTCs, or circulating tumor cells, increase the sensitivity of tumor cell detection in the CSF and should be performed when available. Furthermore, this recommendation is finding its way now into other medical textbooks as well, specifically the frequently updated medical textbook called UpToDate, which is published online by Wolters Kluwer, also recommends CTCs as part of their diagnostic workup for LM. In their chapter on the clinical features and diagnosis of LM from solid tumors, they note that CTC's increased sensitivity for the diagnosis of LM when combined with other tests. Now to the last and fourth important point I wanted to emphasize. We have recently expanded the CNSide intellectual property portfolio of 8 issued patents that were acquired through the filing of 5 new patent applications, substantially extending the life of the acquired IP portfolio by another 20 years. Finally, to finish up, I would like to discuss the business opportunity, next steps and future milestones. Prior to our involvement, CNSide was commercialized for several quarters prior to the financial distress of the developer in 2023. So a few important facts. At the time, and it still is, the only commercially available product platform for CFS testing and in particular, CTC or circulated tumor cell quantification. From Q1 2021 to Q1 2022, the first full year of commercial launch, before our acquisition of the CNSide assets, CNSide test orders experienced a 27% compound annual growth rate. During this period, over 200 different physicians from more than 150 medical facilities across the United States placed an average of 120 test orders per month. Notably, this growth was achieved with no KOL peer-reviewed publications at the time or any formal recommendations by key opinion leaders on the use of CSF, circulating tumor cells in clinical practice. Additionally, direct feedback from KOL thought leaders in neuro-oncology, to me personally actually, was overwhelmingly positive. As I inquired about the test and its utility, they emphasize its crucial role in maintaining, in managing leptomeningeal disease, with many referring to it as a game changer in their practice. So building on this work and drawing on our understanding of LM epidemiology from the analysis for our radio therapeutic analysis, there are about 100,000 to 150,000 new patients every year in the U.S. diagnosed with LM. And with the test ability to monitor disease progression, as mentioned above, we can conservatively estimate a U.S. market potential or TAM of about 500,000 tests annually, and in our view, with very attractive gross margins based on our experience thus far and with comparables. Now to put this transaction in strategic context for Plus, while it's atypical for therapeutic-focused companies to consider commercial opportunities in the diagnostic space, I'd like to recap the 4 basic reasons this makes sense for us. First and strategically, the availability of this test materially increases the size of our LM therapeutic market potential by 2x to 4x. Furthermore, customer call points for LM diagnosis and our radio therapeutic are identical. Opportunistically, it represents a sizable unmet medical and market need that is achievable in the near term, with potential margins similar to therapeutics. In addition, in the radiopharma space, therapeutic and diagnostic payers, aka theragnostics, are commonplace and this aligns with that practice. Finally, our analysis shows us that we can build out the opportunity, create stockholder value and have the potential to attract a pure-play diagnostic partner to monetize or spin out the outset without taking our eye off the radiotherapeutic ball. All right. So moving on. What are the next steps on the path forward to make this goal a reality? Number one, we are on track to have provisional CLIA license filed in Q3 for our existing K2bio facility in Houston, Texas, to further CPRIT grant support to help offset further development costs. Number two, with provisional CLIA accreditation in place, our goal is to launch the CSF-01, that's the CTC or circulating tumor cell test; and CSF-02 the -- in situ hybridization products as LDTs, laboratory developed test, as soon as Q4 2024. There are no current plans for CSF-03 or gene sequencing testing. Number three, at the same time, we will also approach FDA regarding future clearance of the test under very recently published new IVD, in vitro diagnostic guidance for LDTs. Four, in parallel, we are working with our reimbursement consultant to obtain a reimbursement level commensurate with the value of the test as indicated by the published data and current clinical recommendations as mentioned above. As it stands today, based on a review of comps, we believe a price in excess of $2,400 per test is supportable which, if achieved, would provide excellent margins at scale. In terms of production, our K2bio facility is fully scalable and equipped to meet all U.S.-based demand assumptions. Implementation of certain scalability measures commenced in Q1 this year will continue throughout 2024. And finally, in addition, we believe there is a clear development pipeline to expand the application of the test, enabling it to address a wider range of clinical CNS cancer scenarios than is currently possible today. So in summary, as a leader in LM therapeutic development, we saw firsthand the critical need for improved diagnostics and LM. Existing diagnostic methods fall short, prompting our initial interest in the CNSide technology. Because of the underdiagnosis of LM, ongoing availability of the CNSide test is critical both for patients and for growth of the market for our lead drug, Rhenium Obisbemeda. This deal works on that basis alone. Based on further diligence, we acquired the full CNSide platform, including 3 key tests, CSF-01, 2 and 3 and related to intellectual property clinical data, commercial data equipment and so on. Data shows that the CNSide offers enhanced diagnostic sensitivity, aiding in the early detection and treatment monitoring of LM. Over the preceding 6 months, multiple key milestones have been met, specifically meeting key clinical trial endpoints in the FORESEE trial, validation via multiple peer-reviewed publications, official endorsements from influential bodies like the NCCN and expanded IP and patent portfolio that strengthens side IP portfolio. With a potential U.S. market opportunity, for about 0.5 million tests in annually, we aim to establish CNSide as the lead CSF diagnostic for LM. Our next steps include obtaining key regulatory clearances, implementing our reimbursement strategy and thoughtfully scaling our operations. I hope you can tell, we're very excited about the future prospects of our radiotherapeutic business and how this fits into the overall story, and we look forward to addressing any questions you may have. Thank you for your time. Cherie, I'll turn it back over to you.

[Operator Instructions] And our first question will come from the line of Michael Okunewitch with Maxim Group.

I'm really glad that you're able to keep this asset going because it truly is something revolutionary, at least in our view. I guess to start off, just given the strength of the data, you really -- you've got well past that threshold for the primary and now you have all these existing publications. Do you think it's necessary to conduct the validation study? Or do you think the existing data should be sufficient on its own to support reimbursement and drive adoption?

That's a great question. Thank you for your enthusiasm, Michael. We're equally enthusiastic. I hope you can tell. It's a great test. So I'm not sure the answer to that, perhaps not. And the reason why is you're trying -- ultimately, from a reimbursement perspective, in the diagnostic space, you're trying to build towards, in this case, NCCN support, which happened naturally in this case. There was such overwhelming KOL thought leader interest in this test being on the market. It sort of drove itself even without the company really behind it, pushing it. So I think there's a very good chance that additional testing for coverage decisions is not necessary. However, for device clearance as part of the new FDA guidance, it may well be that additional clinical testing is going to be required. And so I think that's something, that guidance is still evolving, we're still looking at it, and we'll kind of lay out a development path going forward as it relates to both reimbursement and additional regulatory clearances.

Right. As a follow-up, the existing NCCN recommendation, could you provide a bit more specifics on what exactly that applies to? And is this something that you can really only evaluate using CNSide, even if it's not explicitly mentioned?

Yes. So in their algorithm and in their clinical practice guidelines, it recommends using a combination of cytology, MRI and clinical testing to evaluate these patients. But based on when available, that the circulating tumor cells should be used as part of the diagnostic workup. It's very clear there. Now generally, as you know, the NCCN guidelines do typically put a product name to it. But CNSide is the only available CTC product that has been on the market. And so it's pretty clear what that refers to. And I think that the way the guidance is worded, it's already -- other resources that follow those guidelines in terms of recommendation, but it's sufficient. There's, in other words, there's -- I don't know that there's a need for any additional clarification of that at this point.

All right. And then one last, just more on the modeling side, and then I'll hop back into the queue. Can you just give a bit more clarity on what additional operating costs would be associated with supporting the CNSide test commercially?

I think it's premature to do that. We've got some very good ideas, but I think we want to continue to vet those assumptions with additional data. And so we're going to roll that out over the next quarter or two. But we think there's an opportunity here because a lot of the heavy lifting has already been done, the development work, the analytic work, the equipment purchasing, the SOPs, the reimbursement work, and we actually have the test. CSF-01 is up and running, CSF-02 will be up and running relatively shortly. The costs are being offset in part through our grant with CPRIT because it's part of our LM trial. It's built into the grant in that respect. So there are multiple moving parts. I don't think the investment is going to be significant to get this out there commercially. And we have a pretty good idea of what the ongoing per test COGS are going to be at scale. And as I mentioned, I think we can do this with something that approaches therapeutic margins.

One moment for our next question. And that will come from the line of Justin Walsh with JonesTrading.

You alluded to this, but can you provide some color on why you believe Plus is better positioned to move this forward than the previous owners of the IP were?

Yes. Justin, thanks for the question. Yes. So I think that -- the previous company was a COVID testing company. They weren't a CSF testing company. They kind of came at this relatively late in their corporate life cycle. And they couldn't overcome the, I think, the weight of the changing environment as it relates to COVID and shift quickly enough to accommodate that flux. So they really were over their skis and couldn't do it. I think if they had focused on this asset, and we were very vested -- to tell you this behind the scenes, we were very vested in the company's survival. It became very clear to us earlier on, this test must survive. This is very important to LM patients. And it's very important to our therapeutic to have solid, high-sensitivity diagnostic techniques for LM available. So if they had focused on this and not COVID, clearly, they put things in place that in terms of getting in NCCN guidelines and building a clinical dossier that is now creating an impact in the market. So they could have, but they just -- they were really under the weight of their other business, which just made it -- I think it enabled for them to pivot quickly. Why can we do it? We're lean, we're already doing it. It's not that difficult. A lot of the heavy lifting had been done previously. We brought that in, shown that we can do the test in our trial. We have a good sense of what the market wants. These are customers, essentially KOL doctors that we talk to every day as part of our LM trial. We know this LM neuro-oncology space as well as anybody and then we could execute operationally. So that's why I think we can do it.

Got it. Sounds good. Given the NCCN guidelines, I'm sure that there are potential competitors who are looking at tests or assays that could satisfy those requirements. Are there any other of the CTC test development that you're aware of?

So as it relates to CSF, no. And there are a number of impediments to testing CSF. It's very different than blood. For example, the technology that we acquired is very unique and allows you to pull out both very rare cells, but do that at a very high dynamic range. There is one of the comps I mentioned that has a $2,400 CPT reimbursement and their own CPT code is for blood technology. It's a different technology. It's optimized for blood testing. So we think that the competitive landscape looks very good for us right now. And I think the recent FDA guidance kind of strengthens that for us because we're -- we have the informational dossier and the quality systems of the FDA process relatively quickly. And that's our intention.

Got it. One more question for me. I'm just wondering if you've had initial conversations or even deeper conversations with different players in the diagnostic space. And if you can give any color on feedback or thoughts from companies who are working in that space?

Yes, we have. And we have on our -- so I think there's a partnership for this in the future. I think we want to, I mean, we want to create the value for our stockholders. But I think we're going to keep a close eye on what the exit looks like and build this to partner. We do not want to be a diagnostic company. We want to be a therapeutic company. But this test has to succeed because it materially changes the upside of Plus Therapeutics based on increasing the number of potential patients to use our radiotherapeutics. So well, we completely divested, perhaps we'll maintain a stake in it. I don't know. We think there's some developmental opportunities, for example, in terms of LM and using a radiotherapeutic. There are certain response metrics in the CSF that could be very important in informing treatment decisions. So we think this is just scratching the surface. So as a per click CSF test, I think while the economics are very attractive, particularly for a company of our size, it's dwarfed by what we can do therapeutically. But we still want to maintain a finger in the pie developmentally because I think this can inform our therapeutic development processes going forward, if that makes sense.

One moment for our next question. That will come from the line of Edward Woo with Ascendiant Capital.

My question is, are you guys only going to focus this on the U.S. market? Or is there any opportunities to bring this to the international market?

Thanks for the question. I think there are opportunities, but we would first get it established in the U.S. And if we didn't have a global partner when we begin, at the time to make a partnering decision, we would consider a region-specific partner, but we have no plans right now to do this outside the U.S. The U.S. market is of such significance and importance and we're already there essentially. It makes sense to just focus on that, build the value and then we'll think about exit and partnering soon thereafter.

One moment for our next question. And that will come from the line of Sean Lee with H.C. Wainright.

I guess, just one on how the CNSide assay fits into the workflow? Is it easy to do the assay as part of the center diagnosis? And is the -- do you need a centralized laboratory to process all the assays or is it done on site?

Thanks for the question, Sean. Yes. So the shipping kits are held in inventory on site. So when a patient comes to the clinic, just like you'd go get a test tube to draw blood, you go get a CNSide collection system, which is proprietary, as I mentioned before, it's a very unique preservative geared for CSF, and preservation of the cells for up to several days so they can continue to do the testing and get valid results. But take that off the shelf. And then in terms of workflow, in worst case, a patient needs a lumbar puncture. And you're kind of early in the diagnostic workup, they may not have a shunt or an Ommaya reservoir, and the lumbar puncture is used to obtain the fluid, which is very straightforward. Any physician can do that in any clinical situation. And then -- and it's simply put in the tubes and it's mailed and it's done in a centralized processing facility. There are some options here to scale this down and put it in a box and do it on site, but we haven't looked at those economics yet. I think we need to validate the market first, establish reimbursement and then we can look at, maybe from a partnering perspective, maybe there's a way to put this in a box and do it on site. But right now, the economics work very well in a centralized facility.

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, Cherie. Thanks, everybody, for joining us. Thank you, Michael, Justin, Ed, for the questions, and Sean. We have -- I think we'll be putting out a press release on that. And we'll talk about the other parts of our business, but we wanted to have this call today to really focus on this and explain what we're doing and why. Thanks for your time. Have a good day.

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