Q4 2023 Plus Therapeutics Inc Earnings Call
Unknown Executive: Good afternoon, ladies and gentlemen. Welcome to the Plus Therapeutics fourth quarter and full year 2023 results conference at this time. All participants are in listen-only mode.
Good afternoon, ladies and gentlemen, and welcome to the plus therapeutics fourth quarter and full year 2023 results conference call. At this time all participants are in listen only mode. After the speaker's presentation. There will be a question answer session.
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Unknown Executive: To withdraw your question, please press star 1-1. This conference is being recorded. 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 Therapeutic's future operating results and financial position. All such statements are subject to risk and uncertainty, including the risk and uncertainty described under the risk factors section included in Plus Therapeutic's annual report. Forum 10-K, and quarterly reports on Forum 10-Q, followed by the Securities and Exchange Commission, advises you to review these risk factors and consider such statements, assumes no responsibility to update or revise any forward-looking statements to reflect events, trends, or circumstances after the date they are made.
Please be advised that today's conference is being recorded before we begin we want to advise you that over the course of the call and question 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.
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Therapeutics assumes no responsibility to update or revise any forward looking statements reflect events trends or circumstances. After the date. They are made it is now my pleasure to turn the floor over to Dr.
Marc H. Hedrick: It is now my pleasure to turn the floor over to Dr. McCarthy. Marc Hedrick, Plus Therapeutics President and Chief Executive Officer. Sir, you may begin. Thank you, Victor. Good afternoon, everyone.
Marc Hedrick, plus therapeutics, President and Chief Executive Officer, Sir you may begin.
Thank you Victor good afternoon, everyone and thank you once again for taking the time to join US today as we provide an overview of recent business highlights and discuss our 2023 full year financial results.
Marc H. Hedrick: And thank you once again for taking the time to join us today as we provide an overview of recent business highlights and discuss our 2023 full year financial results. And right up front, apologies for the hoarseness in my voice as I come back from the flu. Joining me for the call today are Mr. Andrew Sims, our Chief Financial Officer, and Dr. Norman LaFrance, our Chief Medical Officer. I'll begin the call this afternoon by reviewing our recent clinical and regulatory progress with a focus on the fourth quarter, and then turn the call over to Andrew to review our financials, and Dr. LaFrance will then join us for Q&A. Let me begin with the updates on our two lead CNS cancer programs.
Right upfront apologies for the horses semi voices I come back from the flu.
Joining me for the call today are Mr. Andrew Sims, our Chief Financial Officer, and Dr Normal of France, Our Chief Medical Officer.
I'll begin the call. This afternoon by reviewing our recent clinical and regulatory progress with a focus on the fourth quarter and then turn the call over to Andrew to review, our financials and Dr. The France, they will be joining us for Q&A.
Let me begin with the updates on our two lead CNS cancer programs.
Marc H. Hedrick: I think we're in an enviable position in the development of our rhenium-obispomated drug in that with the recent progress we have made in LM, this effectively means we have two promising lead clinical programs for LM and recurrent GBM. Our RESPECT-LM Phase 1-2 Dose Escalation Trial of a Single Administration of Rhenium Obispo Meta for LM continues to show positive safety and effic In November 2023, at the Society for Neuro-Oncology meeting, or SNO, we presented results from the Respect study. We showed that 13 patients with LM received a single interventricular dose of rhenium obispimata between 6.6 and 44 millicuries through an indwelling amia reservoir. No DLTs were observed, and the maximum tolerated dose (mean maximum feasible dose) was not reached. The majority of adverse events were mild, 64% grade one or moderate, 27% grade two, and overall critical organ radiation doses were low. Rhenium ibis tomato circulated throughout the CSF space by one hour following administration and persisted in the CSF for up to seven days, again with a single administration.
We're in the enviable enviable position in the development of our Iridium Obispo made of drug and that with recent progress. We have made an L. M. This effectively means we have two promising lead clinical programs for <unk> in recurrent GBM.
Our respect L. M phase <unk> dose escalation trial of a single administration of Radium Obispo Meda for L. M continues to show positive safety and efficacy signals and is making very good progress.
In November 2023 at the Society for Neuro oncology meeting our snow we presented results from their respect.
We showed that in 13 patients with L. M received a single intraventricular dose of Iridium Obispo made up between $6 six escalating up to 44 militaries in.
And dwelling Amaya reservoir.
No dlt's were observed and the maximum tolerated dose mean maximum feasible dose was not reached.
The majority of adverse events were mild 64% grade one or moderate 27% great too.
And overall critical organs radiation doses were low.
Rhenium of estimated circulated throughout the CSF space by one hour following administration and persisted in the CSF for up to seven days again with a single administration.
Marc H. Hedrick: C.S. decreased by up to 91% following rhenium abyssinomate treatment, and the mean reduction was 53%. Seven of 13 treated patients remained alive at the time of reporting, with a median overall survival of 10 months for patients in the first three cohorts. That's cohorts one through three, www.thevenusproject.com. Excuse me. Enrollment is on track to finish the Phase I Single Administration Dose Escalation Trial by year end. 2024, and also along the way to determine a recommended phase two dose for a single administration phase two three trial. This assumes complete enrollment through cohort seven, and currently, we anticipate that cohort seven is likely the max dose. Cohort 4, just completed, had the fastest enrollment of all the cohorts to date, and cohort 5 is now enrolling.
CSI.
Okay decreased by up to 91% following a road.
Of the estimated treatment and the mean reduction was 53%.
Seven a 13 treated patients remained alive at the time of reporting with a median overall survival of 10 months for patients in the first three cohorts cohorts one through three.
Yeah.
Excuse me enrollment is on track to finish the phase one single administration dose escalation trial by year end.
2024 and also.
Along the way to determine a recommended phase two dose for a single administration.
Phase two three trial this assumes complete enrollment through cohort seven and currently we anticipate that cohort seven it's likely the Max dose.
Cohort four just completed was the fastest enrollment of all the cohorts to date and cohort five is now enrolling.
Marc H. Hedrick: I can tell you that for both the neuro-oncology community and at sites, enthusiasm remains very high for this trial, and we have recently opened five new clinical trial sites. Later this year, our plan is to meet with the FDA and discuss a potential phase two, three pivotal trial design, assuming the data set remains positive and continues. Accelerated Development Approach focusing on metastatic breast cancer for which we have orphan designation. This would be for a single administration of rhenium obispomata.
I can tell you that from both the neuro oncology community.
Sites enthusiasm remains very high for this trial.
And we have recently awarded five new clinical trial sites.
Later this year our plan is to meet with the FDA and discuss the potential phase three pivotal trial design, assuming the data set remains positive we continue.
<unk> development approach focusing on metastatic breast cancer for which we have orphan designation.
This would be for a single administration of <unk>.
Marc H. Hedrick: The trial size, endpoints, and other key trial elements will be discussed later in the year, but we anticipate substantial financial support for this trial through our CPRIT award. In terms of LM data, we anticipate presenting interim safety and feasibility data from the RESPECT-LM trial at the Snow-ASCO-CNS Cancer Conference in August of 2024, and likely updating that for the full Phase I at the Snow Annual Meeting in November 2024. We are also currently working to expand the LM trial to accommodate multiple doses to maximize disease impact in the long term. As an aside, patients are requesting additional treatments of rhenium obispumata following their first administration in our current trial, so we are increasingly treating more patients with additional doses under a compassionate use protocol, which anecdotally seems to be going well from both a safety perspective and a clinical impact, both of We have developed a proposed approach for a multiple dose expansion and anticipate meeting with the FDA in 2024 with the goal of enrollment beginning for the dosing expansion in early 2025, if not before. Now switch gears a bit, but still within the LM discussion.
Obispo made up.
The trial size endpoints and other key trial elements will be discussed later on in the year, but we anticipate substantial financial support for this trial through our Secret Award.
In terms of L. M data, we anticipate presenting interim safety and feasibility data from that respect L. M trial at the snow ESCO CNS cancer conference in August of 2024, and likely updating that for the full phase one at the snow annual meeting in November 2020.
Sure.
We are also currently working to expand the <unk> trial to accommodate multiple doses to maximize disease impact in the long term.
As an aside patients are requesting additional treatments of radium Obispo Meda following their first administration in our current trial. So we are increasingly treating more patients with additional doses under compassionate use protocol.
Which anecdotally seems to be going well from both a safety perspective at a clinical impact both of which are being closely followed.
We have developed a proposed approach for a multiple dose expansion and anticipate meeting with the FDA in 2024 with the goal of enrollment beginning for dosing expansion in early 2025, if not before.
Now, let's switch gears, a bit but still within the.
Marc H. Hedrick: Please recall that we acquired rights to a highly specific, sensitive cerebrospinal fluid tumor cell testing technology in September of 2023. We remain exceptionally encouraged by this test, but as you may recall, the prior company had very significant financial and operating issues. Our rationale for acquiring this test was that it could double the market size for LM therapeutics because of its significant diagnostic sensitivity improvement over standard of care, but it also allows for longitudinal disease assessment that is otherwise very difficult or impossible to do with the current standard of care in testing. The update on this test is that we have successfully implemented the test back into our RESPECT-LM trial, losing only a few patients in cohort 4 as of February 2024. The diagnostic work is being conducted in conjunction with our partner, K2Bio, in Houston. The assay uses proprietary technology and a broad panel of 18 monoclonal antibodies largely geared toward various adenocarcinomas and melanoma.
The LTM discussion.
Please recall that we acquired rights to a highly specific sensitive.
Repo spinal fluid tumor cell testing technology in September of 2023.
We remain exceptionally encouraged by this test.
As you May recall, the prior company had very significant financial and operating issues.
Our rationale for acquiring this was that because it could a double the market size for <unk> therapeutic because of its significant diagnostics sensitivity improvement over standard of care.
But also it allows for longitudinal longitudinal disease assessment that is otherwise very difficult or impossible to do with the current standard of care and testing.
The update on this test is that we have successfully implemented the test back into our respect Lf trial, losing only a few patients in cohort four as of February 2020 for the diagnostic work is being conducted in conjunction with our partner <unk> in Houston.
The assay uses proprietary technology and a broad panel of 18 monoclonal antibodies largely geared towards various adenocarcinoma and melanoma.
Marc H. Hedrick: Working with K2, we can perform the test in a cost-effective manner for our trials and leverage existing grant funding for support. We are in the process of assessing whether broadening the test commercially beyond our trials and our current partnership with K2 is indeed viable. But overall, we continue to think this potential exciting new upside opportunity is great for the company. Now, finally, the Respect LM Phase 1 program continues to be funded in part through CPRIT. The State of Texas through a three-year $17.6 million product development research award. That continues to go very well, and in September, we received a planned $1.9 million payment followed by a $3.3 million payment this past December as part of the grant contract. To date, we have received approximately $7 million from SEPRIT, and we anticipate receiving an additional $6.9 million in 2024, and I think Andrew will provide more detail on the SEPRIT grant revenue in a moment.
Working with <unk>, we can provide performed the test in a cost effective manner for our trials and leverage existing grant funding for support.
We are in the process of assessing whether broadening the test commercially beyond our trials.
And our current partnership with K two is indeed viable.
But overall, we continue to think this potential exciting new upside opportunity is great for the company.
Now finally with respect to <unk> Phase one program continues to be funded in part through separate.
The state of Texas through a three year $17 6 million product Development Research Award that continues to go very well and in September we received a planned $1 9 million dollar payment followed by a $3 $3 million payment. This past December as part of the contract.
To date, we have received approximately $7 million from separate and we anticipate receiving an additional $6 9 million throughout 2024, and I think Andrew will provide more detail on the separate create revenue in a moment.
Marc H. Hedrick: Now an update on our RESPECT GBM trial of a single dose of rhenium bispomida given via convection enhanced delivery to patients with recurrent glioblastoma or GBM. Respect GBM continues to enroll patients, and we are actively adding new clinical trial sites. Until recently, we have been limited in terms of trial sites based on the NCI NIH.
Now an update on our respect GBM trial of a single dose of <unk> that given via convection enhanced delivery.
Two patients with recurrent glioblastoma or GBM.
Respect GBM continues to enroll patients and we are actively adding new clinical trial sites.
Until recently, we have been limited in terms of trial sites based on the NCI NIH.
Marc H. Hedrick: Grant Funding Award, which has substantially supported this trial through the principal investigator, Dr. Andrew Brenner, and the University of Texas. Going forward, in 2024, we will expand trial sites, more efficiently interface with sites, and provide broader and more direct corporate support for the trial. We're incredibly grateful for the five-year support from the NCI, the University of Texas, and the trial PI up to this point as we take the ball to move the trial from phase two to a pivotal trial. We anticipate adding a total of five to eight new sites this year, which is currently ongoing, and we think that's going to provide a strong starting basis for a pivotal trial commencing in 2025. The impact of those sites on enrollment will be felt in the latter part of 2024, and we hope to complete phase two enrollment in late 2024 or early 2025.
Grant funding award, which has substantially supported this trial through the principal investigator, Dr. Andrew Brenner and the University of Texas.
Going forward in 2024.
We will expand trial sites more efficiently interface with sites and provide broader and more direct corporate support for the trial.
Incredibly grateful for the five year support from the NCI University of Texas in the trial pie up to this point as we take the ball and move the trial from phase II to a pivotal trial.
We anticipate adding a total of five to eight new sites this year.
It is currently ongoing and we think thats going to provide a strong starting basis for a pivotal trial commencing in 2025.
The impact of those sites on enrollment will be felt in the latter part of 2024, and we hope to complete phase III enrollment in late 2020 for early 2025.
Marc H. Hedrick: Last November, we presented initial positive safety and feasibility data from the Phase 2 RESPECT-DBM trial at the SNO meeting last November. As a reminder, the primary endpoint of that phase 2 trial is to assess overall survival following a single dose of rhenium obespimata in recurrent GBM and compare that to standard of care. In summary, that data showed median overall survival in the 15 patients from the phase 2 study treated at that time was 13 months; median overall survival was 13 months versus approximately 8 months for the standard of care, and 9 of the 15 patients remained alive at the time of the analysis. Rinneum abyssumata continues to demonstrate a very favorable safety profile, despite delivering up to 20 times the dose of radiation that is typically delivered by external beam radiation therapy And that's typically around 35 gray, and we've gone up to 740 gray.
Last November we presented initial positive safety and feasibility data from the phase II respect DBM trial at the Snow meeting last November.
As a reminder, the primary endpoint of that phase II is to assess overall survival. Following a single dose of <unk> in recurrent GBM and compare that to standard of care.
In summary that data showed median overall survival in the 15 patients from the phase II study treated at that time was 13 months median overall survival of 13 months versus approximately eight months for the standard of care in.
And nine of the 15 patients remained alive at the time of the analysis.
Median progression free survival was 11 months compared to Bevacizumab, which is three four months.
Rhenium Avista made it continues to demonstrate a very favorable safety profile, despite delivering up to 20 times. The dose of radiation that is typically delivered by external beam radiation therapy for GBM and Thats typically around 35, Gray and we've gone up to 740 Gray and the mean dose we're giving now is about 300.
Marc H. Hedrick: And the mean dose we're giving now is about 300 to 350 grays. In 13 of 15 patients, or 86% of patients, have thus far met the empirically-derived rhenium-obispamate dosing target threshold that we've established in Phase I and in preclinical studies of greater than 100 gray average absorbed dose to the tumor and greater than 70% tumor coverage. The phase two trial performance, in terms of median overall survival, will be controlled in Phase 2 using real-world data generated in conjunction with our partner, Metadata, who has a sizable database of GBM and a history of using that successfully in GBM trials with the FDA. In phase one with metadata, we conducted two real-world data trials in RGBM, one versus babucizumab monotherapy and another versus other convection-enhanced delivery trials that were propensity-matched to our phase one data and those two trials in terms of median overall survival.
350, Greg.
And 13 of 15 patients or 80, 86% of patients have thus far met the empirically derive radium of estimated dosing target threshold that we've established in the phase one and in preclinical studies of greater than 100, great average absorbed dose to the tumor and greater than 70% tumor coverage.
The phase III trial performance in terms of median overall survival will.
We will be controlled in the phase II using real world data generated in conjunction with our partner metadata, who has a sizable database in GBM and a history of using that successfully at GBM trials with the FDA.
And the phase one with metadata, we conducted two real world data trials in our GBM, one versus Bevacizumab monotherapy another versus other convection enhanced delivery trials that were propensity matched to our phase one data.
And those two trials in terms of median overall survival.
Marc H. Hedrick: That was aligned with a recent meta-analysis showing the current standard of care in recurrent GBM in terms of median overall survival is approximately eight months. And so currently, we view that as an effective clinical hurdle rate, if you will, in phase two and in phase 3. So comparing our phase two data as it stands as of November of last year versus real world data, that's the last time we reported data, a median overall survival, as a reminder, was 13 months, which is 63% better than the current standard of care, which is BEVUS-Isabab monotherapy, for example, that carries an overall survival of approximately eight months.
That was aligned with the recent meta analysis showing current standard of care in recurrent GBM.
In terms of median overall survival is approximately eight months and so currently we view that as an effective clinical hurdle rate, if you will and a phase II and in a pivotal.
So comparing our phase II data as it stands.
As of November of last year versus real World data that is the last time, we reported data.
Median overall survival as a reminder, was 13 months, which was 63% better than current standard of care, which is <unk> says about monotherapy. For example that has carriers had overall survival of approximately eight months.
Marc H. Hedrick: Also, I'd like to highlight another presentation of our imaging data that was also presented at the same meeting in November by the trial PI. Imaging is an important secondary endpoint in the trial, supporting the overall survival signal, and has until recently been difficult to assess because pseudoprogression has been commonly noted in patients that are receiving such a high dose of radiation, namely 10 to 20 times over EBRT. It was a very technical presentation; it can be found on our website, but the bottom line is that using advanced imaging techniques beyond standard MRI and T1, T2 weighted images, using things such as relative cerebral broad volume, treatment response assessment maps, and flip books, we can increasingly, if not reliably, delineate pseudo progression from progression, as well as better understand patterns of recurrence.
Okay.
Also I'd like to highlight another presentation.
Of our imaging data that was also presented at the same meeting in November by the trial Pi.
Imaging is an important secondary endpoint in the trial.
Supporting the overall survival signal it has until recently been difficult to assess because pseudo progression has been commonly noted in patients that are receiving such a high dose of radiation, namely 10 to 20 times over <unk>.
It was very technical presentation can be found on our website, but the bottom line is that using advanced imaging techniques beyond standard MRI in tier one tier two weighted images using things such as relative cerebral blood volume treatment response assessment maps inflict setbacks, we can increasingly if not really.
<unk> delineate pseudo progression from progression as well as better understand I understand patterns of recurrence and we think this is going to help ensure that we are able to more rapidly.
Marc H. Hedrick: And we think this is going to help ensure that we are able to more rapidly develop and improve upon this novel new therapy for GBM, but also adapted for primary GBM and other brain cancers in children and adults. And related to that point above, I thought it might be useful for me to take a couple of minutes and do a little bit of a forward-looking reframe of this GBM development program that we've been working on and look at In my view, what we've developed is not it's not ideal to think about this as sort of a pure play GBM drug therapeutic per se. But rather, I think it's more accurate to think about this as a novel targeted radiotherapeutic delivery ecosystem that can overcome not just the limitations of external beam radiation therapy, which is the mainstay of GBM therapy. In other words, we've increased by 10 to 20 times the amount of absorbed radiation dose over EBRT.
Develop and improve upon this novel new therapy for GBM.
But also adapted for primary GBM and other brain cancers in children and adults.
And related to that point above I thought it might be useful for me to take a couple of minutes and do a little bit of a forward looking repay reframe. This GBM development program that we that.
We've been working on and look at it and sort of a unique way based on what we've learned over the last over three years of development.
And in my view, what we've developed is not it's not ideal to think about this as sort of a pure play GBM drug therapeutic per se.
But rather I think it's more accurate to think about this as a novel targeted radio.
Therapeutic delivery ecosystem.
That can overcome not just the limitations of external beam radiation therapy, which is the mainstay of GBM therapy.
Yeah.
In other words, we've increased by 10% to 20 times the amount of absorb radiation dose over <unk>, but when you couple that with the state of the art imaging the custom treatment planning with specific software. That's now available the neuro navigational technology and convection enhanced delivery catheters that are optimized we can.
Marc H. Hedrick: But when you couple that with state-of-the-art imaging, the custom treatment planning with specific software that's now available, the neuro-navigational technology, and convection-enhanced delivery catheters that are optimized, we can also overcome the limitations of the blood-brain barrier that makes drugging GBM a very challenging matter, and also overcome the limitations of the aggressive local invasiveness that is well-known with GBM, So given the safety margins that we have seen thus far, with only a single administration of the radiotherapeutic drug, And using the convection delivery modality, we see tremendous opportunity and potential in both improving upon the standard of care and radiation delivery for GBM, which is EBRT in general, but also improve upon current standard approaches for treating GBM, such as surgery and radiation therapy. Chemotherapeutic, and then expanding into other CNS tumor types of the Brain Parenchyma, and I'm happy to discuss this more in the Q&A session.
Also overcome the limitations of the blood brain barrier that makes drugging GBM, a very challenging matter and also overcome the limitations of the aggressive local invasiveness that is well known with GBM, which makes complete surgical resection almost impossible.
So given the safety margins that we have seen thus far.
With only a single administration of the radio therapeutic drug and.
And using the convection delivery modality, we see tremendous opportunity and potential in both improving upon the standard of care.
In radiation delivery for GBM, which is <unk> in general, but also improve upon current standard approaches for recurrent GBM.
Such as surgery and <unk>.
<unk>.
Chemotherapy at X and then expanding into other CNS tumor types.
Of the brain parenchyma and I'm happy to discuss this more.
In the Q&A session.
Marc H. Hedrick: Now, in terms of data, we anticipate an update at SNO in November 2024. We also intend to meet with the FDA in 2024, both on the GBM pivotal trial design and to obtain FDA I&D approval to begin enrollment in the RESPECT Pediatric Brain Cancer Trial for Children with High-Grade Glioma and Epidemioma. To meet our clinical goal of being in pivotal trials in 2025 with our rhenium-obispomated drug, we are focused on expanding our GMP manufacturing relationships in 2024 to such that we have two fully validated manufacturers that can support primary drug supply, backup drug supply, scale-up activities, and all foreseeable commercial demand forecasts. So, relatedly, we are working to build in redundancy in all supply chain intermediaries, including radioiso We think rhenium is an exciting new clinically relevant radioisotope.
Now in terms of data, we anticipate an update at snow in November 2024, we also intend to meet with the FDA in 2024, both on the GBM pivotal trial design.
And to obtain FDA approval to begin enrollment other respect pediatric brain cancer trial for children with high grade Glioma independent moment.
Okay.
Okay.
To meet our clinical goal of being in pivotal trials in 2025 with Iridium Obits permitted drug we are focused in 2024 to expand our GMP manufacturing relationships.
Such that we have to fully validated manufacturers that can support primary drug supply backup drug supply scale up activities at all foreseeable commercial demand forecast.
So relatedly, we are working to build in redundancy and all supply chain intermediaries, including radio radioisotope target and radiation services. We think rhenium is an exciting new clinically relevant radioisotope in interest and that is very high.
Marc H. Hedrick: An interest in that is very high, and we are currently on track to meet both of these important drug production supply objectives. In terms of building out the pipeline, we are focusing on two discrete areas. Our new radiotherapeutic, which is rhenium nanoliposome biodegradable alginate microsphere, a long term, but we call it RNL BAM, and building on our organizational expertise and success in obtaining non-diluted grant funding. First, as it relates to R and L BAM.
We are currently on track to meet both of these important drug production supply objectives.
In terms of building out the pipeline, we are focusing on two discrete areas, our new radio therapeutic which is really a man of liposome biodegradable alginate micro sphere.
Long term, but we call it our enel Bam.
And building on our organizational expertise and success in obtaining non dilutive grant funding.
First as it relates to Arnelle Bam.
Marc H. Hedrick: As a reminder, this is a next-generation radioembolic device, as it was designated by the FDA as of last year, designed to treat a variety of solid organ tumors as the FDA path is now resolved. Analyzing key device design attributes that we think will ensure this is an attractive product for both liver cancer and other cancers, and we'll provide more updates as that develops over the year. Second, as to the issue of grants, we currently have over $20 million in active funding for our two lead programs in LM and GBM. In 2023, we filed for approximately $7 million in grant funding and plan to increase that to at least $10 million in 2024. As per our practice, we report on specific grant funding only when it is awarded. Now, with that update, I'll turn the call over to our CFO, Andrew Sims, who has reviewed the financials. Andrew. Thank you, Marc. Good afternoon, everyone.
As a reminder, this is a next generation radio embolic device.
As it is now designated by the FDA as of last year, which is designed to treat a variety of solid organ tumors as the FDA path is now resolved.
Analyzing key device design attributes that we think will ensure this is an attractive product for both liver cancer and other cancers, and we'll provide more updates as that develops over the year.
Second as to the issue of grants, we currently have over $20 million in active awarded funding for our two lead programs in <unk> and GBM.
In 2024, we filed for excuse me in 2023, we filed for approximately $7 million in grant funding.
We plan to increase that to at least $10 million.
In 2024 as prior practice, we report on specific grant funding only when awarded.
Now with that update I'll turn the call over to our CFO, Andrew Sims to review the financials Andrew.
Thank you Marc and good afternoon, everyone. Please refer to our press release issued earlier today for a summary of our financial results for the fourth quarter and year ended December 31 2023.
Andrew J. Sims: Please refer to our press release issued earlier today for a summary of our financial results for the fourth quarter and year ended December 31, 2023. As of December 31, 2023, cash and cash equivalents were $8.6 million, compared to $18.1 million as of December 31, 2022. We projected to receive an additional $6.9 million in grant funding from CPRIT in 2024, with $3.3 million in the first half of 2023, sorry, 2024, and a balance of $3.6 million by the end of the year. In addition, as Marc mentioned, the company continues to benefit from grant awards of $3 million from the NIH to support the GBM trial through phase two. Based on cash in hand and committed grant funding, our current balance sheet provides runway into the second half of 2025.
As of December 31, 2023, cash and cash equivalents were $8 6 million compared to $18 1 million as of December 31, 2022.
We are projected to receive an additional $6 9 million in grant funding from separate in 2024 with $3 3 million in the first half of 2023, sorry 2024.
On the balance of $3 6 million by the end of the year.
In addition, as Mark mentioned the company continues to benefit from Grant awards of $3 million from the NIH to support the GBM trial to phase II.
Based on the cash on hand, and committed grant funding our current balance sheet provides runway into the second half of 2025.
The company recognized $4 9 million of grant revenue during the year ended December 31, 2023, compared to <unk> $2 million in 2022, reflecting the progress made on the Ellen L. M indication in 2023.
Andrew J. Sims: The company recognized $4.9 million of grant revenue during the year ended December 31, 2023, compared to $0.2 million in 2022, reflecting the progress made on the LM indication in 2023. We expect grant revenue will continue to increase during 2024 and the remaining term of the CPRIC grant through August 2025. As we plan to expand the LM clinical trial to add clinical sites and enroll additional patients, total operating expenses for the year ended December 31, 2023, will be $18.2 million, compared to $19.7 million in the same period in 2022, the decrease due to lower professional and legal expenses.
We expect <unk> revenue will continue to increase during 2024 and the remaining term of the secret Grant through August 2025.
As we plan to expand the <unk> clinical trials at clinical sites and enroll additional patients.
Total operating expenses for the year ended December 31, 2023, $18 2 million compared to $19 7 million in the same period 2022, the decrease due to lower professional and legal expenses.
Other income increased from 147000 in 2022 to 400, thousands in 2023 and fully offset interest expense.
As a result of these changes the net loss decreased by $6 9 million from $20 3 million in the year ended December 31 2022.
The $13 3 million in the year ended December 31 2023.
And now I'll turn it back to you Mark.
Great.
Thank you Andrew.
Andrew J. Sims: Other income increased from $147,000 in 2022 to $400,000. 2023, and Fully Offset Interest. As a result of these changes, the net loss decreased by $6.9 million from $20.3 million in the year ended December 31, 2022. 13.3 million in the year ended December 31, 2023, and now I'll turn it back to you, Marc. Great. Thank you, Andrew. Before we move on to Q&A, I'll take a moment to provide guidance on selected key milestones anticipated over the next 12 months. First,
Before we move onto Q&A I'll take a moment to provide guidance on selective selected key milestones anticipated over the next 12 months.
First.
We have safety and efficacy data from the phase one respect <unk> trial with the snow ASKO CNS meeting.
In August of 2024, and likely further update at the full on snow meeting in October 2024.
We anticipate completing the phase one trial in <unk> by the end of 2024 and we're on track.
The auction develop a phase two three pivotal trial design for breast cancer patients with <unk> in conjunction with the FDA.
We will also be working with the FDA in 2024 to develop a multiple dosing approach.
Potentially further extend tumor impact of iridium obispo, Meda and Leptomeningeal patients.
Marc H. Hedrick: We presented safety and efficacy data from the Phase 1 RESPECT-LM trial at the SNO-ASCO CNS meeting in August of 2024 and likely further updates at the full-on SNO meeting in October 2024. We anticipate completing the Phase 1 trial in LM by the end of 2024, and we're on track for that. Functions to develop a phase 2-3 pivotal trial design for breast cancer patients with LM in conjunction with the FDA. We will also be working with the FDA in 2024 to develop a multiple dosing approach to potentially further extend tumor impact in the rhenium obispomata and leptomeningeal patient.
And our GBM program, we intend to expand trial. This trial sites as mentioned and complete enrollment in the phase two trial.
By late 2020 for early 2025 and in parallel finalize pivotal trial design.
Planning with the FDA.
And Thats partially done.
At this point.
Pending IND clearance from the FDA, we intend to initiate the phase one pediatric brain cancer trial for pediatric brain cancer patients.
And we also plan to bolster our iridium of estimated supply chain for commercial readiness in 2024 as well as complete device development optimization milestones for our next generation radio embolic device or an L band.
Now with those key milestones I'll turn the call back over to Victor.
Marc H. Hedrick: In our GBM program, we intend to expand trial sites, as mentioned, and complete enrollment in the Phase 2 trial by late 2024 or early 2025, and in parallel, finalize pivotal trial design planning with the FDA. That's partially done at this point, pending IND clearance from the FDA. We intend to initiate the phase one pediatric brain cancer trial for pediatric brain cancer patients.
<unk>.
Introducing any questions we might have.
Victor Thank you as a reminder to ask a question you will need to press star one on your telephone and wait for NIM to be announced two I'd draw. Your question. Please press star one again.
We compile the Q&A roster.
One moment for our first question.
Our first question comes from the line of Justin Walsh from Jones trading your line is open.
Unknown Executive: And we also plan to bolster our Iridium Obispomata supply chain for commercial readiness in 2024, as well as complete device development optimization milestones for our next generation radioembolic device, RNL-BEM. Now with those key milestones, I'll turn the call back over to Victor to introduce any questions we might have.
Hi, Thanks for taking my questions you alluded to this but I was wondering if you could provide some more color on the current availability of rhenium 186, and what it will take to scale up and the potential clinical and then commercial demand.
Hi, Justin it's Mark So if you kind of model out.
I think in the near term near to intermediate.
That term.
2020 for 2025 2026 being in pet.
Unknown Executive: Thank you. As a reminder, to ask a question, you will need to press star 11 on your telephone and wait for a name to be announced. To withdraw your question, please press star 11 again.
Pivotal trials, and having commercial quality phase III quality drug.
We can essentially scale from our current providers. So we're talking about maybe somewhere between five two.
Unknown Executive: Please stand by, we'll compile the CUNY roster moment for our first question. The first question comes from Justin Walsh from Jones Trading. Hi, thanks for. You alluded to this, but I was wondering if you could provide some more color on the current availability. Hi, Justin, it's Marc.
Eight doses a week.
Throughout the year that can be further scaled up by adding more days to the week.
So what we're really doing is kind of looking at <unk>.
Commercial assumptions based on GBM, which is a much much smaller.
Indication as you know, it's about 15000 patients in the U S every year versus L. M, which is a much bigger number of patients. So that's going to require as mentioned an additional GMP manufacture.
Marc H. Hedrick: So if you kind of model out, I think, in the near term, near to intermediate term, 2024, 2025, 2026, being in pivotal trials and having a commercial quality phase three drug, we can essentially scale from our current providers. So, you know, we're talking about, you know, maybe somewhere between five to eight doses a week throughout the year that can be further scaled up by adding more days to the week. So what we're really doing is kind of looking at commercial assumptions based on GBM, which is a much, you know, much smaller indication. As you know, it's about 15,000 patients in the US every year versus LM, which is a much larger number of patients. So that's going to require, as mentioned, an additional GMP manufacturer.
So we will have at least two GMP manufacturers that can meet the GMP.
Manufacturing goals that we've set for ourselves from a commercial perspective that should.
That's what we're talking about now having five to 10 years of GMP supply.
A manufacturing perspective.
We also.
We are also.
Looking at increasing the radiation services provider.
Provided to a second.
Provider as well.
To make sure that.
Radioisotope is radio isotopic services is not a.
Limiting in the overall supply chain, it's not limiting now we have plenty of upside and ability to increase specific activity with our current provider, but kind of looking downstream three.
Marc H. Hedrick: So we'll have at least two GMP manufacturers that can meet the GMP manufacturing goals that we've set for ourselves from a commercial perspective. That should, you know, we're talking about now having five to 10 years of GMP supply from a manufacturing perspective. We also, we are also, looking at increasing the radiation services provider provided to a second provider as well to make sure that radioisotope services are not limiting in the overall supply chain. It's not limiting now.
Three to five years, we would have to bring on additional radiation services and then in terms of the other supplier intermediates.
We really have those pretty well in place, it's really about building up backup supply agreements.
And then a risk mitigation through increasing shelf life.
Improving.
Inventory.
Got it. Thanks, one more question for me you had mentioned that Youre still evaluating the long term commercial potential of the CN side assay I was just wondering if you could share any initial thoughts about potential clinical utility of the assay outside of or in addition to rename Odessa Nader.
Marc H. Hedrick: We have plenty of upside and the ability to increase specific activity with our current provider, but kind of looking downstream, you know, three to five years, we'd have to bring on additional radiation services. And then, in terms of the other supply intermediates, we really have those pretty well in place. It's really about building up backup supply agreements and then risk mitigation through increasing shelf life and improving inventory.
Okay.
Yeah, Thanks, Justin so.
From looking at a few different levels. So first just from our trial, we see a.
Yes.
We see a step function improvement in.
And diagnosis and also in disease management potential just in our and our patients are small number of trials sooner Ellen trial, thus far so we see it firsthand the value there.
Marc H. Hedrick: One more question. You mentioned that you're still evaluating the situation, and I was wondering if you'd share any initial thoughts about, "Yeah, for mediocrity."
It kind of a second level when we talk to.
Clinical trial sites, which are the CCN.
Marc H. Hedrick: Yeah, thanks, Justin. So, you know, from looking at a few different levels. So first, just from our trial, we see a step function improvement in and Diagnosis, and also in disease management potential just in our patients, our small number of trials in our LM trial thus far. So we see it firsthand, the value there, it's kind of a second level when we talk to Clinical Trial Sites, which are the NCCN. Sites primarily in the U.S., and we talked to those principal investigators who are interested in our trial. This assay was off the market for a few months.
It's primarily in the U S.
And we talk to those principal investigators are interested in our trial.
This this.
This.
<unk> was off the market for a few months.
There was really a big hole in their from their perspective and their therapeutic and.
In diagnostic armamentarium, not having that test so we.
From from their side too from.
<unk> centers that werent, even in our trial.
And then as we look at the magnitude of the under diagnosis of <unk>.
Marc H. Hedrick: There was really a big hole in their, from their perspective, in their therapeutic and diagnostic armamentarium, not having that test. So we, from their side to physicians and centers that weren't even in our trial. And then as we look at the magnitude of the underdiagnosis of LM. We think LM is probably two to four times underdiagnosed based on autopsy studies. We sort of lump all those all those things together.
LM is probably two to four times under diagnosed based on autopsy studies.
We sort of lump all those things together.
It impacts us therapeutically by significantly increasing that.
The size of the market.
Adjusted you know this but thats a very significant potential.
Increase in our ability to treat patients and create value for shareholders.
Then.
There's also the opportunity to follow patients. So if you are following patients over.
Marc H. Hedrick: It impacts us therapeutically by significantly increasing the size of the market. And I know Justin, you know this, but that's a very significant potential increase in our ability to treat patients and create value for shareholders, and then there's also the opportunity to follow patients. So if you're following patients for months or years, you're improving survival. This assay could be used as a potential surrogate biomarker to determine when it's appropriate to treat patients, and that sort of further magnifies the commercial opportunity. So even though it's a diagnostic opportunity, it impacts us by expanding the therapeutic market, but also as a standalone diagnostic opportunity. It's actually very meaningful.
<unk> or years, improving survival. This assay can be used as a as a.
Surrogate biomarker to determine when it's appropriate to retreat patients so that that sort of further magnifies the commercial opportunity. So.
Even though it's a diagnostic opportunity it impacts us by expanding the therapeutic market, but also as a standalone.
Diagnostic opportunity, it's actually very meaningful we're not interested really long term of being in the diagnostic.
Business per se, but it's so closely aligned with what we do therapeutically and it's a very unique opportunity.
In an unmet.
Medical area that we think it's well worth going forward from a commercial perspective and Thats our goal.
Marc H. Hedrick: We're not really interested, long term, in being in the diagnostic business per se, but it's so closely aligned with what we do therapeutically. And it's a very unique opportunity in an unmet medical area that we think it's well worth going for it from a commercial perspective. And that's our goal. Thanks. Thanks, Justin.
Great. Thanks for taking my questions.
Thanks, Justin.
One moment for our next question.
Yeah.
Our next question comes from the line of Sean Lee from H C. Wainwright. Your line is open.
Good afternoon, guys and thanks for taking my questions I just have two quick ones.
Unknown Executive: Thank you. One moment for our next question. The next question comes from Sean Lee from H.C. Wainwright. Your line is open. Good afternoon, guys. And thanks for taking my questions. I just have two quick ones.
First we'll be CNS side is.
Is it you mentioned that you're starting to be used studying in the first quarter. So when we start to see more results based on that from I guess cohorts for royalty on study.
Unknown Executive: First, for the CNS side, you mentioned that it's starting to be used in the first quarter. So when will we start to see more results based on that from, I guess, cohort four of the LM study? Hi Sean.
Yes.
Hi, Sean Yes, I think yes, I want to be clear. So the test is actually up and running we have all 18 monoclonal is up and running.
Marc H. Hedrick: Yeah, I think, yeah, I want to be clear. So, yeah, the test is actually up and running. We have all 18 monoclonals up and running. We have the microfluidics, the trans, been running. We missed, more or less, cohort four when the test was unavailable.
We have the microfluidics.
The transfer.
We've been running we missed more or less we missed cohort four when the test was unavailable.
In cohort five and so youll start seeing additional data from cohort five thats our goal.
Yes.
So absolutely.
Marc H. Hedrick: We're in cohort five, and so you'll start seeing additional data from cohort five onwards. That's our goal. So, absolutely, we're looking forward to having that data again, as are the investigators quite frankly. Great, thanks for the clarification, and as a follow-up on that, for the potential future pivotal study that's coming next year, do you see CMS-Sci serving as a primary endpoint for that study, or will it be more used alongside more standard measures such as the OS and response rate? Yeah, a good question.
We're looking forward to having that data get as are the investigators quite frankly.
Great. Thanks for the clarification.
Follow up on that.
Sure.
Potential future pivotal study that's coming next year do you see C&I side serving us.
Our primary endpoint for that study or would it be more used alongside more standard measures such as <unk> and response rate.
Yes.
Yes, good question I'm going to let Dr. Lee.
France take the brunt of that question, but I can't.
I think.
Marc H. Hedrick: I'm going to let Dr. LaFrance take the brunt of that question, but I can tell you that most likely, this will be used as an exploratory endpoint in our LM Pivotal, Phase 2, 3 pivotal trial. We just don't have enough data yet to know how we might incorporate that as a primary endpoint. But, you know, I think long term it could be in LM.
Most likely this will be used as an exploratory endpoint.
In.
Our pivotal phase III pivotal trial.
Don't have enough data to know how we might incorporate that as as the primary endpoint, but.
I think long term it could be in <unk>.
Another reason why we think it's a valuable test for these patients but Dr. <unk> would you like to talk a little bit about primary endpoint selection and <unk>.
Norman LaFrance: Another reason why we think it's a valuable test for these patients. But Dr. LaFrance, would you like to talk a little bit about primary endpoint selection in LM? Uh, sure, Marc.
Sure Mark Thanks, John Great question and for Lam.
I think it's important to look at what our options are so.
Mentioning on the <unk> side.
Norman LaFrance: Thanks. And Sean, great question. And for LM, I think it's important to look at what our options are. So, on the CN side, given the study and how FDA typically feels about surrogate endpoints, probably the most realistic, as Marc mentioned, is a secondary or exploratory endpoint.
Given given the study and where FDA typically feels about surrogate endpoints.
Probably the most realistic as Mark mentioned is the secondary or exploratory end point and we'll be we'll be positioning that and getting some of those data as we progress the current phase.
Phase one monotherapy and as Mark mentioned in his remarks, there are several additional Ellen.
Norman LaFrance: And we'll be positioning that and getting some of those data as we progress with the current phase one monotherapy, and as Marc mentioned in his remarks. There are several additional LM programs that will be starting later this year or early next year; we would expect all of those to have the CN-SIDE assay in some regard as a secondary or exploratory end. Those data will really drive what makes sense in terms of generating the best pivotal database.
Programs that will be.
Starting later this year or early next year.
We would expect all of those to have the EC inside assay in in.
In some regard as a secondary or exploratory end point those data will really drive.
What makes sense in terms of generating the best our pivotal database.
Norman LaFrance: But I think it's important to underline how the investigators feel about this, this test, and they've been using it before the current, you know, the prior company's difficulty, and a lot of standard of care applications, and it has been very successful. In terms of trial endpoints, although we have reported OS, Of course, we know the agency. Likes and OS primary, I think we all need to remember LM is a very tragic, difficult to treat complication of a primary tumor. We would anticipate focusing on breast cancer with the leptomeningeal, Complications, for several reasons. First of all, that's one of the main contributors to electromeningeal complication.
But I think it's important to underline how the investigators feel about this test and.
They've been using it before the current.
The prior companies difficulties.
Standard of care applications.
And very successfully.
In terms of trial endpoints, although we have reported OS.
Of course, we know the agency.
Likes and OS primary endpoint I think we all need to remember <unk> is a.
Very tragic and difficult to treat complication of the primary tumor.
I would anticipate focusing on breast cancer with the Leptomeningeal.
Complications for several reasons first of all Thats one of the main contributors to our Leptomeningeal complication and as we all know FDA is very.
Norman LaFrance: And as we all know, FDA is very, very specific about wanting disease-specific indications. And we've already accomplished their, you know, preliminary agreement by having orphan drug designation for that indication. In terms of endpoints, OS would certainly be one of the, I would anticipate that it will likely be a secondary endpoint despite some of our very provocative and promising preliminary information, only because we know that what drives the patient's survival is their primary tumor. In our current database, we have seen that the patients that although have gotten some benefit, both some clinical benefit and certainly the benefits of CSF tumor reduction that Marc mentioned in his remarks. The one the patient that unfortunately have all expired from the primary, So the important thing with this indication will be the control of the leptomeningeal complication, so their medical oncologists can focus on the treatment of their primary tumor, giving them more runway for that.
Very specific on wanting disease specific indications.
We've already accomplished.
Sure.
Preliminary agreement by having orphan drug designation for that indication.
In terms of endpoint OS would certainly be one of the endpoints I would anticipate that likely to be a secondary endpoint. Despite.
Some of our very.
Provocative and promising preliminary information only because we know what drives these patient survival is their primary tumor in our current database we have seen that.
Patients that although we have gotten some benefit both some clinical benefit and certainly the benefits of CSF tumor reduction that Mark mentioned in his remarks.
The patients that unfortunately.
Buyers have all expired from the primary tumor so the important thing with this indication will be the control leptomeningeal complications so their medical oncologist can focus on the treatment of the primary tumor giving them more runway for that all of this needs to be reviewed with FDA and thats the plan.
Norman LaFrance: All of this needs to be reviewed with FDA, and that's. I'll stop here and see if that satisfied your question, and I'll be happy to give you more, more feedback, if you'd like. Thank you, Norman. That's very helpful.
I'll stop here and see if that satisfied your question and happy to give you more and more feedback if you'd like.
Thank you Norman that's very helpful and.
Norman LaFrance: And my last question is for Andrew. Could you provide us with an overview of how much of the support grants are still left and what stakes, how much do you expect to recognize over the next Hey Sean, thanks for the question. So at this point, we have additional funding expected from separate sources of just over $10 million through kind of as allocated from now through August 2025, which would be the end of the three-year period. So how do we expect and how do we forecast that to break down is really into three additional payments to be received. The first payment should be received late in the first half of this year, and it will be about $3.3 million, approximately.
My last question is for Andrew.
Could you provide us with the overview on how much of the clients are still left and whats takes how much do you expect to recognize over the next year.
Thanks, Sean Thanks for the question.
So at this point we have.
Additional fund funding expected from say a period of just over $10 million.
Kind of as I look at it from now through August 2025, which would be the end of the three year period.
So how that how we expect to me how we forecast that to break down is really in three additional payments to be received.
The first payment is should be received.
In the first half of this year.
And it will be about $3 3 million approximately we then expect your next incremental advanced some separate should be.
Andrew J. Sims: We then expect the next incremental advance in CIPRIT to be $3.6 million to be received on or about the end of this year. And then the final piece in the balance will be received probably early to mid 2025. Great. Thank you for that. That's all the questions I have.
$3 6 million.
To be received on or about the end of this year.
And then the final piece and the balance will be received.
In probably early to mid 2025.
Great. Thank you I don't see that across all of the questions I guess.
Andrew J. Sims: Thank you. Thank you. One moment for our next question, which comes from the line of Edward Woo from Ascendant Capital.
Thanks, Sean.
Thank you one moment for our next question.
Our next question comes from the line of Edward Woo from <unk> Capital. Your line is open.
Edward Moon Woo: Congratulations on all the progress. You mentioned that you guys were going to look for $10 million in grant proposals this year, on top of $7 million last year. What are you seeing in terms of the landscape for grant opportunities out there? Is the pot getting bigger? Is the pot getting smaller? Is the pot about the same?
Yes, congratulations on all the progress you mentioned that you guys were going to look for $10 million.
Our proposals this year on top of $7 million last year. What are you seeing in terms of the landscape for grant opportunities out there.
The park getting bigger to pocketing smaller part about the same and what about the competitive landscape.
Marc H. Hedrick: And what about the competitive landscape? People looking for grants, how is that impacting your ability to get there? Thank you. You know, I don't see a big change over the last few years. Grants are hard to get. And, you know, the yield is low, which means you need to put a lot of, you know, a lot of them out there to get, you know, one or two.
Other people look for grants how is that impacting your ability to get these grants.
Thank.
I don't see a big change over.
Over the last few years grants are hard to get.
And.
The yield is low which means you need to put a lot of a lot of them out there to to get one or two.
Marc H. Hedrick: So, you know, we are at an advantage, not only because we have unmet medical needs, but also because we're a Texas-based company, and that opens up what is still the second largest funder of cancer research in the world, which is the state of Texas and SEPRIT. And we've had success. In fact, we have one of the biggest SEPRIT grants ever given, which is for LM. So I think we have a pretty good chance... We have a great working relationship with SEPRIT. We have a very good understanding of how to get those grants. We know that there are companies that have received up to three of those grants, and we know the process for that. So, you know, I think we'll continue to look not only at the more traditional U.S. governmental grants but also at CPRT as well. And Development, that non-dilutive funding allows us to, you know, really manage our balance sheet in a materially different way than we would otherwise have to.
So.
We are an advantage.
Not only because we have we have unmet medical needs.
But also we're a Texas based company and that opens up.
Is this still.
The second largest funder of cancer research in the World, which is the state of Texas in secret.
And we've had success in fact, we have one of the biggest secret grants ever ever given which is for.
So I think we have a pretty good we have a great west we have a great working relationship with secret we have a very good understanding.
How to get those grants, we know that there are companies that have.
Up to three of those grants and we know the the.
<unk> for that so.
I think we'll continue to look not only at the more traditional.
U S governmental grants.
But also look at secret as well.
And in development that non dilutive funding.
Allows us to.
Really to manage R. R.
Our balance sheet.
And a materially different way that we would otherwise have to.
Marc H. Hedrick: And so it really makes a lot of sense leveraging, you know, a very experienced team in terms of getting grants to continue to seek those for the foreseeable couple of years or so as we hopefully bridge to approved products and revenue. Well, congratulations again, and I wish you guys good luck. Thank you. Thank you. Thank you. Now I'll turn it over to Andrew for questions. Thanks, Victor. So we have one question, and it's for Dr. LaFrance.
It really makes a lot of sense leveraging.
Very experienced team in terms of.
Getting grants to continue.
To seek those.
For the foreseeable couple of years or so.
As we hopefully bridge two approved product and revenue.
Great well, congratulations again and I wish you guys. Good luck. Thank you.
Thank you.
Thank you and now I'll turn it over to Andrew for any questions.
Thanks, Victor So we have one question and it's sort of all adults on the France.
Andrew J. Sims: What is the status of the pediatric trial and when do you expect to start treating patients? Thanks, Andrew. Great question.
What is the status of the pediatric trial and when do you expect to start treating patients.
Yes.
Thanks, Andrew.
Norman LaFrance: You know, as everyone heard, Marc touched on that briefly at the end of his remarks that we have been to FDA and we'll be following up with them for submitting the final IND for approval. I would add that FDA has embraced and is very pleased with PLUS and is pursuing the pediatric indications for high-grade glioma and ependymoma. So, you know, we already have basically an agreement with FDA for the pediatric protocol. They just had some final minor questions.
Great question.
Everyone heard mark touched on that briefly at the end of his remarks.
We had been to FDA and we will be following up with them for submitting the final IND for approval.
I'd add that FDA has embraced and are very pleased with.
With plus and are pursuing a PDR.
<unk> indications.
For high grade Glioma independent Moma.
So.
We have we already have basically agreement with FDA for the <unk>.
Pediatric protocol.
They had some final minor questions.
Norman LaFrance: Not so much on the pediatric protocol conduct, which, like I said, we have their preliminary agreement, but some additional GBM data that we've generated in adults around dosimetry, all of which is very straightforward. We committed to get that information back to them as we've enrolled more phase 2 adult patients. We will be getting that data to FDA in the first half of this year, which we hope means we will be getting, and be able to enroll, by the second half of 2024, our first patients. Importantly, we have our pediatric site, our first pediatric site identified, and preparation at that site is well underway, and the principal investigators at that site are already well engaged and partnering with us for that. So PEEJ is on track, and it's been very well embraced by the community. All right, Andrew, any other, any other..., email questions. That is it. Okay, thank you.
Not so much on the pediatric protocol conduct which like I said, we have their preliminary agreement.
Some additional some GBM data that we've generated in adult surround dosimetry all of which is very straightforward, we committed to get that information back to them as we've as we've enrolled more phase III adult patients, we will be getting that data to FDA in the first half of this year.
Which we hope means we will beginning.
Be able to enroll.
By second half of 2024, our first patients importantly, we have our pediatric site first pediatric sites identified and preparation at that site is well underway and the principal investigators that site are.
Already well engaged in.
And partnering with partnering with us for that so pizza.
<unk> is on track and it's been very well embraced by the agency.
Sure.
Alright, Andrew any other any other.
E mail questions.
That is it Tonight.
Okay. Thank you.
Marc H. Hedrick: All right. I want to thank everybody for joining us. Again, thank you to the investigators and patients and employees who work so hard. And we're obviously very excited about where the company is right now. And this is a great road ahead of us in 2024.
Alright.
I want to thank everybody for joining US again, thank you to the investigators and patients and employees.
Who worked so hard and we're obviously very excited about where the company is right now and this is a great Great Road ahead of us.
Unknown Executive: So we appreciate your time and your interest, and we'll look forward to talking to you next time. Thank you, Victor. Thank you for your participation in today's conference. This does conclude the program. You may now disconnect. Everyone has a great day.
Thousand 24, so we appreciate your time and your interest and we'll look forward to talking to you next time. Thank you Victor.
Thank you. Thank you for your participation in today's conference. This does conclude the program you may now disconnect everyone have a great day.
Okay.
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