Q1 2024 Plus Therapeutics Inc Earnings Call
Operator: Good afternoon, ladies and gentlemen. Welcome to the Plus Therapeutics first quarter 2024 results conference call. Before we begin, we want to advise you that during 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.
Operator: 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. Mark Hedrick, Plus Therapeutics President and Chief Executive Officer. Sir, you may begin.
Good afternoon, ladies and gentlemen, welcome to the plus Therapeutics first quarter 2024 results 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 effect, 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.
First therapeutic 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.
Speaker Change: And Chief Executive Officer, Sir you may begin.
Marc H. Hedrick: 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 first quarter 2024 financial results. Joining me on the call today are Mr. Andrew Sims, our Chief Financial Officer, and Dr. Norman LaFrance, our Chief Medical Officer. I'll begin the call by reviewing our recent corporate and clinical progress in the first quarter and then turn the call over to Andrew to review our financials.
Speaker Change: 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 first quarter 2024 financial results.
Speaker Change: Joining me for the call today are Mr. Andrew <unk>, our Chief Financial Officer, and Dr. Norman The France, our Chief Medical Officer.
Speaker Change: I'll begin the call by reviewing our recent corporate and clinical progress for the first quarter and then turn the call over to Andrew to review our financials.
Marc H. Hedrick: Dr. LaFrance will then be joining us for Q&A. Let me begin by highlighting some recent corporate updates before discussing our specific therapeutic and diagnostic programs. So first of all, on May 9th, 2024, we closed a private placement financing for an aggregate proceeds of up to $19.25 million, which consisted of an initial upfront funding of approximately $7.25 million and up to an additional approximately $12 million upon cash exercise of accompanying warrants at the election of the investors.
Speaker Change: Dr. The France, then will be joining us for Q&A.
Marc H. Hedrick: The financing included participation from AIGH Capital Management, LLC, with additional participation from health care-focused institutional investors and insiders. Second, we received a notice of award for a $3 million grant from the United States Department of Defense. Congressionally Directed Medical Research Program. The award will be used to fund a Phase 1-2 trial for pediatric patients with high-grade glioma and ependymoma following IND approval from the FDA. As a reminder, this grant illustrates our ongoing strategy to use external grant funding to support the initial preclinical and clinical development of new technology or indications while minimizing the impact on the balance sheet and shareholder dilution.
Speaker Change: Let me begin by highlighting some recent corporate updates before discussing our specific therapeutic and diagnostic programs.
Speaker Change: So first of all on May 9th 2024, we closed a private placement financing for an aggregate proceeds of up to $19 two $5 million, which consisted of an initial upfront funding of approximately $7 $2 5 million and up to an additional approximately $12 million.
Speaker Change: On cash exercise of accompanying warrants at the election of the investors.
Speaker Change: The financing included participation from AIG H capital management, LLC with additional participations from health care focused institutional investors and insiders.
Speaker Change: Second we received a notice of award for $3 million Grant from the United States Department of Defense.
Speaker Change: Congressionally directed medical research programs.
Speaker Change: The award will be used to fund a phase one two trial for pediatric patients with high grade Glioma independent Mama following IND approval from the FDA.
Speaker Change: As a reminder, this graph illustrates our ongoing strategy to use external grant funding to support the initial preclinical and clinical development of new technology or indications, while minimizing the impact to the balance sheet and shareholder dilution.
Speaker Change: More specifically.
Marc H. Hedrick: Our GBM program had just been acquired when we found out that we had a five-year grant funding from the NCI to fund that program through Phase 1-2. Our LM program received nearly $18 million of funding over three years from CPRIT. And today, that strategy continues with this DOD award for Pediatric Brain Cancer Therapeutic Development. We're going to continue to leverage our novel technology. Subject Matter and Grant Management Expertise to drive this strategy forward for the foreseeable future.
Speaker Change: Our GBM program.
Speaker Change: Just been acquired when we.
Speaker Change: Found out that we had a five year.
Speaker Change: Grant funding from the NCI to fund that program to phase one two.
Speaker Change: Second.
Speaker Change: Our LTM program received nearly $18 million of funding over three years from separate and today that strategy continues with its TLD award for pediatric brain cancer therapeutic development.
Speaker Change: We're going to continue to leverage our novel technology subs.
Speaker Change: Subject matter and grant management expertise to drive this strategy forward for the foreseeable future.
Speaker Change: Finally.
Marc H. Hedrick: [inaudible] Strengthen our team for planning for forthcoming pivotal trials. We added neuro-oncologist Dr. Andrew Brenner and Dr. Barbara Blau to our management team. Dr. Brenner is an MD-PhD and has been instrumental in developing rhenium-obispo-meta and the related clinical strategy. And Dr. Blau is a PhD with extensive experience in clinical operations, CNS tumor biology, biomarker development, and neoplasms of the cerebrospinal fluid.
Speaker Change: To strengthen our team for planning for forthcoming pivotal trials, we added neuro oncologists, Dr. Andrew Brenner and Dr. Barbara <unk> to our management team Dr. Brenner as an M. D ph D. It has been instrumental in developing rhenium obispo Meda and the related clinical strategy and Dr. Brough has a ph D with extensive experience.
Speaker Change: <unk> and clinical operations.
Speaker Change: Ines tumor biology, biomarker development and neoplasms cerebral spinal fluid.
Marc H. Hedrick: Now, in terms of our clinical programs, I'll begin with updates on our RESPECT-LM Phase 1 Dose Escalation Basket Trial for Single Administration of Rhenium Obispimator for Leptomeningeal Metastasis. This trial is substantially funded by a three-year, nearly $18 million product development award from CPI. During Q1, we announced the enrollment of the three required patients for dosing in cohort 5 at a single radiation dose of 66.1 millicuries. As of the most recent data update in March 2024, 12 of 18 patients who received the dose remained alive.
Speaker Change: Okay.
Speaker Change: Now in terms of our clinical programs I'll begin with updates on our respect L. M phase one dose escalation basket trial for.
Speaker Change: <unk> for a single administration of Iridium Obispo Meda for Leptomeningeal metastases.
Speaker Change: This trial is substantially funded by a three year nearly $18 million product development award from secret.
Speaker Change: During Q1, we announced the enrollment of the three required patients for dosing in cohort five at a single radiation dose of $66 one militaries.
Speaker Change: As of the most recent data update in March 2024, 12 of 18 patients dose remained alive.
Marc H. Hedrick: Multiple compassionate use doses have now also been made available to clinicians for patient survivors that have exceeded the trial follow-up period and continue to do well. We expect to present updated enrollment and safety data at the SNO-ASCO meeting in August 2024 in Denver. Furthermore, investigator and KOL enthusiasm for the trial and the investigational therapy remains high and continues to grow. Recently, we added an additional five sites to the trial that will participate in patient recruitment for both the phase one and subsequent follow-on trials.
Speaker Change: Multiple compassionate use doses have now also been made available to clinicians for patient survivors that have exceeded the trial follow up period. It continued to do well.
Speaker Change: We expect to present updated enrollment and safety data at the snow Astro meeting in August 2024, and Denver.
Speaker Change: Furthermore, investigators and Kols enthusiasm for the trial and the investigational therapy remains high it continues to grow.
Speaker Change: Recently, we added an additional five sites the trial that will participate in patient recruitment for both the phase one and subsequent follow on trials.
Marc H. Hedrick: Our goal is to complete enrollment in the Phase 1 Basket Trial for a single dose this year and then to present the full data set from all cohorts of the Phase I trial as they exist at that time at the SNO annual meeting in November 2024 in Houston. In parallel, we are presently in dialogue with the FDA regarding a multi-dose expansion arm of the Phase I trial. Ultimately, we believe multiple doses of rhenium bisbomida will be the optimal therapeutic approach to suppress and potentially cure LM.
Speaker Change: Our goal is to complete enrollment in the phase one basket trial.
Speaker Change: For a single dose this year and then to present the full data set from all cohorts.
Speaker Change: Of the phase one trial.
Speaker Change: As they exist at that time at the Snow annual meeting in November 2024 in Houston.
Speaker Change: In parallel we are presently in dialogue with the FDA regarding a multi dose expansion arm of the phase one trial.
Speaker Change: Ultimately, we believe multiple doses of iridium <unk> will be the optimal therapeutic approach to suppress at potentially cure.
Marc H. Hedrick: We will provide an update once the plan is finalized and FDA approval is obtained. Additionally, as we move forward towards a recommended phase two dose of rhenium abyssinomate for LM, We intend to expand our communications with the FDA regarding a pivotal phase 2-3 trial design, which is currently in development with our team and KOL advisors. The initial planned pivotal trial will be focused on LLM and metastatic breast cancer, for which we have orphan designation from the FDA last week.
Speaker Change: We will provide an update once the plan is finalized and FDA approval is obtained.
Speaker Change: Additionally, as we move forward towards a recommended phase two dose of iridium burst from Meda for L. M.
Speaker Change: We intend to expand our communications with the FDA regarding a pivotal phase III trial design, which is currently in development with our team and KOL advisers.
Speaker Change: The initial planned pivotal trial will be focused on <unk> in metastatic breast cancer for which we have orphan designation from the FDA.
Speaker Change: Last week, we hosted an investor call focused on the acquisition of the synergistic L M diagnostic platform.
Marc H. Hedrick: We hosted an investor call focused on the acquisition of the synergistic LM diagnostic platform called C-Insight. Rather than fully revisiting the details of that call today, I would like to provide the highlights and encourage you to listen to the recording, which can be found on our website, to learn more about this tremendous new opportunity for the company. So here are the key highlights.
Speaker Change: Let's see inside.
Speaker Change: Rather than fully revisiting the details of that call today I would like to provide the highlights and encourage you to investigate the recording.
Speaker Change: When you, which can be found on our website to learn more about this tremendous new opportunity for the company.
Speaker Change: So here are the key highlights and I'll begin with the four key points outlining the rationale for the acquisition first of all.
Marc H. Hedrick: And I'll begin with the four key points outlining the rationale for the acquisition. First of all, Leptomeningeal cancer is a tough diagnosis to make, and the current state-of-the-art diagnostics, which include MRI and cytology, lack diagnostic sensitivity. Second, we developed experience with the CN-Side assay in our RESPECT-LM trial and saw firsthand its value. Additionally, we have the opportunity to engage with multiple KOL physicians who have come to see the C-Inside assay as a game changer in their practice. Third, autopsy studies indicate LM is likely significantly underdiagnosed.
Speaker Change: Leptomeningeal cancer is a tough diagnosis to make and the current state of the art diagnostics, which include MRI in cytology lack diagnostics sensitivity.
Speaker Change: Second.
Speaker Change: We developed experience with the C inside assay in our respect Lf trial and saw firsthand its value.
Speaker Change: Additionally, we have the opportunity to engage with multiple kols and physicians, who have come to see see inside assay as a game changer in their practice.
Speaker Change: Third.
Speaker Change: <unk> studies indicate L M is likely significantly under diagnosed.
Marc H. Hedrick: As such, an enhanced diagnostic such as C-Inside means more patients may be able to take advantage of our rhenium-obispomata therapy for LF. Finally, we recognize that there is a substantial standalone commercial opportunity to develop, commercialize, and then monetize the CSI technology in the near future. So, based on that rationale and our supporting analysis, we exclusively acquired all essential C-Inside-related assets to provide C- First of all, cancer cell enumeration, or CTC, circulating tumor cell testing, which we call CSF-01. This quantifies adenocarcinoma and melanoma tumor cells in the CSF.
Speaker Change: Such an enhanced diagnostics such as C. Inside means more patients may be able to take advantage of iridium Obispo made a therapy for <unk> lab.
Speaker Change: Finally, we recognize that there is a substantial stand alone commercial opportunity to develop commercialize and then monetize see inside technology in the near term.
Speaker Change: So based on that rationale.
Speaker Change: And our supporting analysis, we exclusively acquired all essential see inside related assets to provide insight testing commercially and this includes three types of tests first of all the cancer cell enumeration, our CTC circulating tumor cell testing, which we call CSF zero one this quantified adenocarcinoma.
Marc H. Hedrick: Second, we obtained the FISH or Fluorescence in Situ Hybridization Testing, we call CSF02, that determines cancer-specific gene expression for therapeutic guidance, and third, we acquired the next generation sequencing of cell-free DNA called CSF03 that analyzes DNA to identify genetic mutations related to LF. In Q1 2024, prior to the acquisition, we validated and clinically implemented the CSF01 test into our RESPECT-LM trial as an exploratory endpoint, and it is currently in use today. As part of the acquisition, we acquired the 4C clinical trial data, which evaluates C-Inside and its clinical utility in addressing therapeutic decision-making at LM.
Speaker Change: Sonoma in melanoma tumor cells in the CSF.
Speaker Change: Second we obtained the fish are fluorescence in situ hybridization testing, we call CSF zero too that determines cancer specific gene expression for therapeutic guidance.
And third.
Speaker Change: We acquired the next generation sequencing of cell free DNA called <unk>, three that analyzes DNA to identify genetic mutations related to <unk>.
Speaker Change: In Q1 2024 prior to the acquisition, we validated and clinically implemented the CSF zero, one test into our respect Lf trial as an exploratory endpoint is.
Speaker Change: It is currently currently in use today.
Speaker Change: As part of the acquisition, we acquired the four C clinical trial data, which evaluates the inside and its clinical utility and addressing therapeutic decision, making at L. M and last week, we disclosed that the trial met its primary endpoint and.
Marc H. Hedrick: Last week, we disclosed that the trial met its primary endpoint, and a presentation of the full 4C trial data is planned for the August 8-10 Snow-ASCO meeting in Denver. So now we are looking forward in terms of next steps.
Speaker Change: A presentation of the full foresee trial data is planned for the August 8th 10th Snow Astro meeting in Denver.
Speaker Change: So now looking forward in terms of next steps we.
Marc H. Hedrick: We will be expanding the availability of the test in our RESPECT trial to longer time points in conjunction with our planned multiple dosing regime. We are also finalizing a complete business evaluation, including a reimbursement optimization strategy, with the intention of commercially launching the test as soon as Q4 2024. As discussed in last week's call, we anticipate a total addressable market of over a half million tests annually with the potential for additional growth.
Speaker Change: We will be expanding the availability of the tests in our respect trial.
Speaker Change: To longer time points in conjunction with our planned multiple dosing regime.
Speaker Change: We are also finalizing a complete business evaluation, including a reimbursement optimization strategy with the attention of commercially launching the test as soon as Q4 2024.
Speaker Change: As discussed in last week's call, we anticipated total addressable market of over half million tests annually with the potential for additional growth.
Marc H. Hedrick: We plan to further discuss the commercial opportunity and the plan at a later date. And finally, in parallel, we are talking to potential diagnostic business development partners that have expressed interest in CNSci. And then finally, just a reminder, you can learn more about the C Insight asset or acquisition of that by visiting our website and looking at the related press release and investor call. Now, we shift gears and discuss our RESPECT-GBM trial, evaluating rhenium obispomate in patients with recurrent glioblastoma.
Speaker Change: We plan to further discuss the commercial opportunity in the plan at a later date.
Speaker Change: And finally in parallel we are talking to potential diagnostic business development partners that have expressed interest and see inside.
Speaker Change: And then finally, just a reminder, you can learn more about the CN site asset our acquisition of that by visiting our website and look at the related press release and Investor call details.
Speaker Change: Okay.
Marc H. Hedrick: We continue to enroll both phase two patients with GBM tumors less than or equal to 20 milliliters and also phase one patients with GBM tumors that are greater than 20 milliliters. And that's in our Dose Escalation Phase 1. It's still ongoing and now in Cohort 8, as the NIH NCI funding for this trial, which has been the primary financial supporter for the trial, is winding down in 2024, and as we work to finish enrollment in the Phase 2 study.
Speaker Change: So now shift gears and regarding our respected GBM trial evaluating rhenium of estimated in patients with recurrent glioblastoma.
Speaker Change: We continue to enroll both phase II patients with GBM tumors less than or equal to 20 milliliters.
Speaker Change: And also phase one patients with GBM tumors that are greater than that.
Speaker Change: And that's in our dose escalation phase one that is still ongoing and down cohort eight.
Speaker Change: As the NIH NCI funding for this trial that I mentioned earlier, which.
Speaker Change: Which has been the finance primary financial supporter for the trial is winding down in 2024.
Speaker Change: And as we work to finish enrollment of the phase II study.
Marc H. Hedrick: We are able to add new sites that will help speed trial completion and set us up for the phase three study. So, besides our Texas sites in Dallas, Houston, and San Antonio, we are now adding three new sites to the trial focused on key population centers. In the upper Midwest, Ohio State University; in the New York area, North Shore and Lenox Hill Hospitals, which are part of the Northwell Network; and in Florida, Advent Health.
Speaker Change: We are able to add new sites that will help speed trial completion and set us up for the phase III study.
Marc H. Hedrick: [inaudible] to enroll in the second half of 2024 and will substantially contribute to a pivotal trial. We have set the goal for ourselves to complete enrollment in 2024 or early 2025, and enrollment timing will be influenced to a significant degree by the participation of these new sites.
Speaker Change: So besides our Texas sites in Dallas, Houston, and San Antonio We are now, adding three new sites for the trial focused on key population centers in the upper Midwest, The Ohio State University.
Speaker Change: And the New York area, North Shore, and Lenox Hill hospitals, which are part of the north well network and Florida advent health.
Speaker Change: These three shop.
Speaker Change: As you enroll in the second half of 2024 and.
Speaker Change: And we will substantially contribute to a pivotal trial.
Speaker Change: We have set a goal for ourselves to complete enrollment in 2020 for early 2025.
Speaker Change: And enrollment timing will be influenced to a significant degree by participation of these new sites.
Marc H. Hedrick: We plan to provide a complete update on the Phase 2 data this fall at one of the key neurosurgery or neuro-oncology meetings; the final meeting designation is to be determined. As a reminder, the data seen and reviewed to date in the Phase 2 trial has been highly promising in terms of both safety and efficacy, demonstrating thus far a 13-month overall survival as of November 2023 compared to approximately eight months for the standard of care or a 63% improvement in OS over standard.
Speaker Change: We plan to provide a complete update on the phase III data. This fall at one of the key neurosurgery, our neuro oncology meeting so that final meeting designation.
Speaker Change: To be determined.
Speaker Change: As a reminder, the data seen and reviewed to date in the phase II trial has been pilot.
Speaker Change: Excuse me highly promising in terms of both safety and efficacy.
Speaker Change: Demonstrating thus far a 13 month overall survival as of November 2023, compared to approximately eight months for the standard of care or 63% improvement in OS over standard of care.
Marc H. Hedrick: As I mentioned last quarter, given the safety profile and the unprecedented amount of radiation we can deliver to the CNS using our technology, we believe there's a tremendous potential for improving upon the standard of care in GBM. And also, there's a broader opportunity to leapfrog the primary means of radiation delivery for all CNS neoplasms, which is essentially external beam radiation therapy at this.
Speaker Change: As I mentioned last quarter, given the safety profile the unprecedented amount of radiation, we can deliver to the CNS using our technology. We believe there is a tremendous potential for improving upon the standard of care in GBM.
Speaker Change: And also there is a broader opportunity to leapfrog the primary means of radiation delivery for all CNS neoplasms.
Speaker Change: It is essentially external beam radiation therapy at this point.
Marc H. Hedrick: We continue to work behind the scenes with existing and potential partners that share our view of this opportunity and want to collaborate to explore its potential in a focused manner. In parallel to our plans to finalize the Phase 1 and Phase 2 trials, we are also planning our pivotal trial strategy and plan to meet with the FDA later this year to discuss the Phase 2 data and agree on the pivotal trial design for GBM.
Speaker Change: We continue to work behind the scenes with existing and potential partners that share our view of this opportunity and we want to collaborate to explore the potential in a focused manner.
Speaker Change: In parallel to our plans to finalize the phase one and phase II trials. We are also planning our pivotal trial strategy and plan to meet with the FDA later this year to discuss the phase II data and align on a pivotal trial design in GBM.
Marc H. Hedrick: Finally, I would like to briefly update you on our Pediatric Brain Cancer Program. As I also noted at the beginning of the call, with U.S. Department of Defense funding support, we will be finalizing our IND with the FDA and initiating a phase one trial for children with pediatric high-grade glioma and ependymoma. We anticipate, based on several previous rounds of discussion with the FDA, that we can obtain IND approval in 2024 and perhaps be ready to begin enrollment early next year at our initial site, Lurie Children's Hospital in Chicago.
Speaker Change: Finally, I would like to briefly update you on our pediatric brain cancer program.
Speaker Change: As I also noted at the beginning of the call with U S Department of Defense funding support we will be finalizing our IND with the FDA and initiating a phase one trial for children with pediatric high grade Glioma independent Mama.
Speaker Change: We anticipate based on several previous rounds of discussion with the FDA that we can obtain IRB approval in 2024, and perhaps be ready to begin enrollment early next year at our initial site very children's hospital in Chicago. Once the final trial details are agreed upon we will provide an update on those.
Marc H. Hedrick: Once the final trial details are agreed upon, we will provide an update on that. Now, with respect to our next generation radioembolic device called the Rhenium 188 or 186 nanoliposome biodegradable degradable alginate microsphere or RNL BAM. As previously mentioned, feedback from the FDA is that BAM will be regulated as a device, not a drug.
Speaker Change: Now with respect to our next generation radio Embolic device called Iridium won 88 or 186, nano Episome biodegradable degradable alginate microspheres for R&R Bam.
Speaker Change: As previously mentioned feedback from the FDA as it band will be regulated as a device not a drug.
Marc H. Hedrick: With that decision in hand, we are now working on the device-related quality system, finalizing the device design requirements, and expanding the related IP portfolio, and I anticipate providing more updates, when warranted, in the near future. Finally, although our current supply chain is both reliable and sufficient for our near-term needs, as we contemplate pivotal trials beginning in 2025, we are devoting significant energy to building out a supply chain that is ready for both pivotal trials and ultimately commercialization.
Speaker Change: With that decision in hand, we are now working on the device related quality system.
Speaker Change: Finalizing the device design requirements and expanding the related IP portfolio.
Speaker Change: I anticipate providing more updates when warranted in the near future.
Speaker Change: Okay.
Speaker Change: Finally, although our current supply chain is both reliable and sufficient for our near term needs as we contemplate pivotal trials beginning in 2025, we are devoting significant energy to build out a supply chain that is ready for both pivotal trials and ultimately commercialization.
Marc H. Hedrick: Two key focus areas are as follows. The first is to have a redundant and high-capacity GMP manufacturing capability. So, to complement our two existing manufacturers of the final drug product, we are in the process of selecting a third partner that meets GMP standards. This addition, serving as an alternative and redundant source, will ensure that, collectively, we can fulfill our demand projections for Iridium Obispumata through 2028. The second focus area is additional radiation services capability.
Speaker Change: Two key focus areas for.
Speaker Change: Far as follows first is to have a redundant and high capacity GMP manufacturing capability.
Speaker Change: So to complement our two existing manufacturers of the final drug product. We are in the process of selecting a third partner that meets GMP standards. This addition, serving as an alternative and redundant source will ensure that collectively we could fulfill our demand projections for iridium obispo made up through 2028.
Speaker Change: Second focus area is for additional radiation services capability, so to support the commercial radio isotope supply a key part of the overall manufacturing process, we will need to expand our network of providers. We are currently well into that process today.
Marc H. Hedrick: So to support the commercial radio isotope supply, a key part of the overall manufacturing process, we will need to expand our network of providers. We are currently well into that process today, and I'll report more as we are able to update. Moreover, we are enhancing both exclusive and non-exclusive supply agreements for key starting or intermediate drug products. We are also refining inventory-based strategies to guarantee reliable drug availability under any foreseeable demand scenario. And with that, I'll now turn the call over to our Chief Financial Officer, Andrew Sims, who will review the financials. Andrew. Thank you, Marc.
Speaker Change: And I'll report more as we are able to update.
Speaker Change: Moreover, we're enhancing both exclusive and nonexclusive supply agreements for key starting our intermediate drug products. We are also refining inventory based strategies to.
Speaker Change: To guarantee reliable drug availability under any foreseeable demand scenario.
Speaker Change: And with that I'll now turn the call over to our Chief Financial Officer Andrew.
Andrew: We will review the financials Andrew.
Andrew J. Sims: Thank you, Marc. Good afternoon, everyone.
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 first quarter ended March 31 2024.
Andrew J. Sims: Please refer to our press release issued earlier today for a summary of our financial results for the first quarter ended March 31, 2024. The cash balance was $3 million at March 31, 2024, compared to $8.6 million at December 31, 2023. The company recognized $1.7 million in grant revenue in the first quarter of 2024, compared to $0.5 million in the first quarter of 2023. This represents Seapridge's share of the cost incurred for our rhenium abyssinomator development for the treatment of patients with LAM.
Andrew: The cash balance was $3 million at March 31, 2024, compared to $8 6 million at December 31, 2023.
Andrew: The company recognized $1 7 million in revenue in the first quarter of 2024 compared to <unk> 5 million in the first quarter of 2023.
Andrew: This represents secret share of cost incurred for our <unk>, a bespoke major development for the treatment of patients with <unk>.
Andrew J. Sims: We expect 2024 grant revenue to be in the range of $6 million to $7 million, i.e. tracking. Total operating loss for the first quarter of 2024 was 3.3 million, compared to 4.8 million in the same period of 2023. The decrease was primarily due to increased grant revenue. Net loss for the first quarter of 2024 was $0.75 per share compared to $2.07 per share for the same period of the prior year.
Andrew: We expect 2024 grant revenue to be in the range of 6 million to $7 million.
Andrew: Tracking.
Andrew: Okay.
Andrew: Total operating loss for the first quarter of 2024 was $3 3 million compared to $4 8 million in the same period of 2023.
Andrew: The decrease was primarily due to increased grant revenue.
Andrew: Net loss for the first quarter of.
Andrew: 2024.
Andrew: Was <unk> 75 per share compared to $2 seven per share for the same period the prior year.
Andrew J. Sims: I would also like to provide a more detailed update on our runway and cash position based on the recently announced private placement and provide guidance on our grant funding for the remainder of 2024. There are two additional sources of cash that Plus has access to beyond the balance disclosed in cash on hand and liquid investments on our Q1 2024 balance sheet. The first, as we announced last week on May 6th,
Andrew: I would also like to provide a more detailed updates on our runway and cash position based on the recently announced private placement and provide guidance on a grant funding for the remainder of 2024.
Andrew: There are two additional sources of cash surplus has access to beyond the balanced disclosed in cash on hand, and liquid investments on our Q1 2024 balance sheet.
Andrew: The first as we announced last week on May six we closed a private placement fund financing of up to $18 million from new healthcare focused institutional investors and company insiders.
Andrew J. Sims: We closed a private placement fund financing of up to $18 million from new healthcare-focused institutional investors and company insiders. In addition, it should be noted that, as reported after the market on Form 8K on May 9, this financing was subsequently upsized to $19.25 million, with a total of $7.25 million received at closing. The $7.25 million amount represents approximately 12 months of incremental runway at our current burn rate. The second source of cash remains our continued funding through now three announced grants.
Andrew: In addition, it should be noted that as reported after market on form 8-K on May nine. This financing was subsequently upsized to $95 million with a total of $705 million received at closing.
Andrew: The seven 5 million amount represents approximately 12 months of incremental runway at our current burn.
Andrew: The second source of cash remains a continued funding through now three announced grants.
Andrew J. Sims: Firstly, the CPRIT grant to support the RespectLM trial. With respect to expected grant advances from CPRIT in 2024, and to be clear, cash advances from CPRIT, we are on track to receive advances totaling $6.9 million in 2024. 3.4 million will be received in late Q2 or early Q3, and an additional 3.5 million will be received in late Q4. Additionally, an additional $3.5 million is earmarked from CPRID in 2025. Secondly, as reported on April 22nd, PLUS has received an award recommendation from the United States Department of Defense for $3 million to support the upcoming RESPECT pediatric brain cancer trial.
Andrew: Firstly, the secret grants to support their respective <unk> trial.
Andrew: With respect to expected granted boxes from secret in 2024 and to be clear cash advanced system Sprint. We are on track to receive advances totaling $6 9 million in 2024.
Andrew: $3 4 million will be received in late Q2, or early Q3, and an additional $3 $5 million or were you received in late Q4.
Andrew: An additional $3 5 million as engie from secret in 2025.
Andrew: Secondly, as reported on April 22nd Pluses received an award recommendation from the United States Department of Defense for one 3 million to support the upcoming respects pediatric brain cancer trial.
Andrew J. Sims: This funding is expected to commence in late Q3 or early Q4 of 2024 and materially cover the costs of the planned phase one trial. Funding is generally received annually in advance and covers a three-year period, i.e., approximately 1 million will be received under this grant in 2024. Plus also continues to benefit from the NIH grant to support the respect GBM Phase 1-2 trial.
Andrew: This funding is expected to commence in late Q3 or early Q4 of 2024.
Andrew: And maturity cover the costs of the planned phase <unk> trial.
Andrew: Funding is generally received annually in advance and covers a three year period.
Andrew: Approximately $1 million will be received under this grants in 2024.
Andrew: Plus also continues to benefit from the NIH grants to support the prospect GBM phase one two trial.
Andrew J. Sims: Although expected to be complete in 2024, it currently covers approximately 90% of the overall trial cost. We also continue to source other non-dilutive sources of grant capital, with the target of applying for at least $10 million per year. We will continue to only report on individual grants when they are awarded.
Andrew: Although expected to be complete in 2024. It currently covers approximately 90% of the overall trial costs.
Andrew: We also continued to source other non dilutive sources of growth capital.
Andrew: With a target of applying for at least $10 million per year.
Andrew: We will continue to only report on individual crops when they are awarded.
Andrew J. Sims: Taken in total, there's cash on hand. Placement financing, warrants, if fully exercised, and committed and contractual grant revenue is in excess of $35 million. I'll now turn it back to you, Marc.
Andrew: Taken in total this cash on hand.
Andrew: Placement financing warrants, if fully exercised and committed and contractual grant revenue is in excess of $35 million.
Mark: I'll now turn it back to you Mark.
Mark: Thank you Andrew.
Marc H. Hedrick: Before we move on to Q&A, I'll take a moment to provide guidance on anticipated key events and milestones taking us through the remainder of 2025. First, in terms of presentations the company will be making, we will attend the Society for Nuclear Medicine Molecular Imaging Annual Meeting in June. That's the 8th through the 11th in 2024.
Mark: Before we move on to Q&A I'll take a moment to provide guidance unanticipated key events and milestones taking us through the remainder of 2024.
Mark: First in terms of presentations.
Marc H. Hedrick: We have two accepted abstracts. The first will be the RESPECT-LM trial and an update of initial safety and feasibility through cohorts 1 through 4. We also have a dosimetry presentation on the radiation absorbed dose to the spinal cord using beta emission radiopharmaceuticals and leptomeningeal metastases.
Mark: The company.
Mark: We will be making.
Mark: We will attend the society for nuclear Medicine molecular imaging annual meeting in June.
Mark: Through the 11th in 2024, we have two accepted abstracts. The first will be the respect <unk> trial, and an update of initial safety and feasibility through cohorts one through four.
Mark: We also have a dosimetry presentation on the radiation absorbed dose to spinal spinal cord using beta emission radiopharmaceuticals and Leptomeningeal metastases.
Marc H. Hedrick: We also intend to attend the SNO-ASCO, or Society for Neuro-Oncology and American Society of Clinical Oncology combined CNS metastases conference, on August 8th through 10th, 2024. We have three anticipated abstracts. The first is the RESPECT-LM trial and an update on enrollment and safety, as mentioned earlier in the presentation. Also, we will be presenting the full 4C clinical trial data set on CSF tumor cell detection and data on its ability to help in the clinical management of breast cancer and non-small cell lung cancer in patients with Leptomeningeal Disease. We'll also have a third presentation, which is based on the feasibility and relevance of C-Inside as a scalable platform for disease management for patients with leptomeningeal disease.
Mark: We also intend to.
Mark: We also intend to attend the snow <unk> our society for neuro oncology.
Mark: And the American Society of clinical oncology combined CNS Metastases conference.
Mark: On August eight through 10, and 2024, we have three anticipated abstracts. The first is the respect <unk> trial, and an update of enrollment and safety as mentioned earlier in the presentation.
Mark: Also we will be presenting the full four C clinical trial dataset on CSF tumor cell detection and data on its ability to help and clinical management of breast cancer and non small cell lung cancer with patients with leptomeningeal disease.
Mark: We will also have a third presentation, which is based on the feasibility and relevance of see inside is a scalable platform for disease management for patients with Leptomeningeal disease.
Marc H. Hedrick: Later in the year, we anticipate a comprehensive update on safety and efficacy data from the Phase 1 RESPECT-LM trial at the SNO annual meeting in November 2024. Also later in 2024, we anticipate a meaningful update on the RESPECT-GBM trial at either a neurosurgical or neuro-oncology meeting, and that exact meeting is to be determined. In terms of FDA updates, we plan to provide feedback when available on two specific workstreams. The first is the RESPECT-LM Type C meeting for a multi-dose Phase 1 dose escalation trial that was created by the FDA and scheduled to meet on June 10, 2024.
Mark: Later in the year, we anticipate a comprehensive update on safety and efficacy data from the phase one respect Lf trial at the Snow annual meeting in November 2024.
Mark: Also later in 2024, we anticipate a meaningful update on the respect GBM trial, either a neurosurgical, our neuro oncology meeting and that exact meeting is to be determined.
Mark: In terms of FDA updates, we plan to provide feedback when available.
Mark: Two specific work streams. The first is the respect <unk> type C meeting for a multi dose phase one dose escalation trial. It was granted by the FDA and scheduled for meeting on June 10 2024.
Marc H. Hedrick: We also anticipate FDA feedback in the second half of 2024 for the respect. New Drug Application for Pediatric Epidemioma and High-Grade Glioma with the aim of securing regulatory approval for the trial. Additionally, we anticipate completing the RESPECT-LM Phase 1 Dose Escalation Trial enrollment this year and determining the maximum tolerated and recommended Phase 2 doses. Also, we will report results of the preclinical combination studies of rhenium-186-obispomata with PD-1 and PD-L1 checkpoint inhibitors when that data is completed.
Mark: We also anticipate FDA feedback in the second half of 2024 for the respect.
Mark: Additional new drug application for pediatric opinion, Moma and high grade glioma with the aim of securing regulatory approval for the trial.
Mark: Additionally, we anticipate completing the respect <unk> phase one dose escalation trial enrollment this year and determining the maximum tolerated and recommended phase two doses.
Mark: Also we will report results of the preclinical combination studies of <unk> 186 of this for me that with PD, one and PDL one checkpoint inhibitors when that data is completed.
Marc H. Hedrick: We also will contract with a second GMP manufacturing supplier to better support the Iridium-186 Obistramida supply for pivotal trials and commercial readiness. And then, as Andrew mentioned, we are on track to file at least $10 million in new grant applications in 2024, and we'll announce those upon receipt of the notification of award. So with that, Victor, I'll turn it back over to you and let's have our Q&A session. Thank you.
Mark: We also will contract with a second GMP manufacturing supplier to better support the Iridium 186 of Bicester Meda supply for pivotal trials and commercial readiness and then finally as Andrew mentioned, we are on track to file at least $10 million of new grant applications in 2024, and we will announce those upon receipt.
Mark: The notification of award.
Victor: So with that Victor I'll turn it back over to you analysts have our Q&A session.
Operator: Thank you. To ask a question, you 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. Once again, to ask a question, press star 11.
Speaker Change: Thank you to ask a question you will need to press star one on your telephone and wait for him to be announce to withdraw. Your question. Please press star one again once again to ask a question Thats Star one please standby, while we compile the Q&A roster.
Operator: Please stand by while we compile the Q&A roster. One moment for the first question. Our first question will come from Justin Walsh from Jones Trading. Your line is open.
Speaker Change: One moment for our first question.
Speaker Change: Our first question comes from the line of Justin Walsh from Jones trading your line is open.
Justin Walsh: Hi, congrats on the progress. Thanks for taking the questions. I know there's a lot of potential variability here, but I was wondering what your current thoughts are on the overall development timelines for a renewable Vista Meta in GBM versus LMS.
Justin Walsh: Hi, Congrats on the progress thanks for taking my questions.
Justin Walsh: I know theres a lot of potential variability here, but I was wondering what your current thoughts are on the overall development timelines for <unk> rhenium Obispo Meda in GBM versus Allen.
Marc H. Hedrick: Hey, Justin, it's Marc. So, you know, I think that the LM development timeline on the whole could actually mean an approved product. Prior to GBS. And if you'd asked me that, you know, a year or two ago, I might have said something different because we were more advanced in GBM. GBM, as you know, has its multiple competitive trials. It's a much smaller number of patients and the. The work required to enroll patients through case planning, and so forth, is materially different than with LM.
Speaker Change: Hey, Jeff since Mark.
Speaker Change: So.
Speaker Change: I think that actually.
Speaker Change: Actually the <unk> development timeline on the whole could actually mean a approved product.
Speaker Change: Meyer to GBM.
Speaker Change: And if you'd asked me that.
Speaker Change: A year or two ago, Might've said something different because we were more advanced in GBM.
Speaker Change: GBM is you know has there are multiple competitive trials its a much smaller number of patients and.
Speaker Change: The.
Speaker Change: The work required to enroll patients to the case planning and so forth is materially different than with <unk>.
Marc H. Hedrick: Furthermore, in comparison, if you look at LM, there's no approved product. We think it is likely that the FDA will accept a phase 2, 3 pivotal trial versus the requirement for a pivotal trial in GBM with overall survival as the end point. So to your question, as it relates to LM, if we sort of say that as the likely first market, if you will, for the rhenium abyssinum beta product. As we think about a potential Phase 2, 3, pivotal single-dose trial for breast cancer beginning early next year, we're thinking about 100 to 150 patients, perhaps a year or less to enroll, and about a half a year in terms So that's kind of where we are on the whole, and I'll just stop there. And Dr. LaFrance wants to weigh in as well. It's a great question.
Speaker Change: Furthermore, there is.
Speaker Change: In comparison, if you look at LLM, there's no approved products.
Speaker Change: We think the likely that the FDA will accept a phase III three pivotal versus the requirement for a pivotal trial in GBM with overall survival as the endpoint.
Speaker Change: So.
Speaker Change: So to your question.
Speaker Change: As it relates to LTM, if we sort of say that is likely.
Speaker Change: First to market, if you will with Iridium <unk> product.
Speaker Change: As we think about a potential phase III pivotal single dose trial for breast cancer.
Speaker Change: Beginning in early next year, we're thinking about 100 to 150 patients.
Speaker Change: Perhaps a year or less to enroll in about a half a year in terms of follow up.
Speaker Change: Then youre kind of looking at.
Speaker Change: At approval timeline, thats pretty potentially aggressive.
Speaker Change: So that's kind of where we are on the hull and I'll just stop there and Dr.
Norman D. LaFrance: It's a great question, Justin. This is Norman LaFrance. Everything that Marc says I think is spot-on in terms of explaining how LM is going. I think a key point I want to emphasize is LM has pleasantly surprised us in the phase 1 dose escalation by showing, similar to GBM, an efficacy signal. We really didn't expect to get that kind of data until phase 2, which Marc mentioned during his remarks, is fully funded through phase 2.
France wants to weigh in as well.
Speaker Change: It's a great question, Justin this is Norman or France.
Norman D. LaFrance: Everything that Mark says I think is spot on in terms of explaining.
Dr. France: Is.
Speaker Change: Going I think a key point I want to emphasizes L. M has pleasantly surprised us into phase one dose escalation by showing similar to GBM, an efficacy signal, we really didn't expect to get that kind of data until the phase two.
Speaker Change: Which mark had mentioned during his remarks is fully funded through phase III given our success in the phase one dose escalation.
Norman D. LaFrance: Given our success in the phase 1 dose escalation, leptomeningeal development is accelerating much more quickly than we anticipated. And, of course, we have to go to FDA with some of the aspects that Marc mentioned in terms of the study design, but instead of a standalone phase 2, there's a reasonable likelihood that we will discuss with FDA a Phase 2-3 pivotal trial, perhaps a Phase 2 with a lead-in to Phase 3. I won't go into the details now, but the key point is, in the last year, the LM data results have been so positive that it's really allowed us to really gain on the GBM trial, in addition to the points Marc made. Thanks. Thank you.
Speaker Change: The Lotto Meningeal development is accelerating much more quickly than we anticipated.
Speaker Change: And of course, we have to go to FDA and some of the aspects that Mark mentioned in terms of the study design, but instead of a stand alone phase II.
Speaker Change: A reasonable likelihood that we could.
Speaker Change: Discuss with FDA, a phase two three <unk>.
Speaker Change: Pivotal trial, perhaps a phase III with a lead into phase III I won't go into the details now, but the key point is in the last year. The L. M data results have been so.
Speaker Change: Positive that it's really allowed us to really gain on the GBM trial. In addition to the points Mark made thanks.
Speaker Change: Thank you got it thanks.
Justin Walsh: Yeah, so my next question, you laid out pretty well the different data catalysts and conferences we can expect things from. I think you mentioned different cohorts. I'm wondering if there's any color you can provide on the kind of expectations on how many additional patients' worth of data we can expect at some of these. I know some, I'm sure it'll change, but by the time I actually get to it.
Speaker Change: Yes. So my next question.
Speaker Change: You laid out I think pretty well the different data catalysts and in conferences. We can expect things I think you mentioned different cohorts.
Speaker Change: Im wondering if theres any color you can provide on kind of expectations on how many additional patients worth of data. We can expect that at some of these.
Speaker Change: I'm sure it'll change by the time, we actually get to the presentation.
Yes.
Marc H. Hedrick: Yeah, so the way I would guide you, Justin, is, as we've said in the past, with respect to GBM, we're looking for another couple of patients in cohort 8, and we think cohort 8 is likely the last cohort, just as a maximum feasible dose.
Speaker Change: Yes.
Justin Walsh: I would guide you Justin is.
Justin Walsh: I think.
Justin Walsh: As we've said in the past.
Justin Walsh: With respect to GBM, we're looking for.
Another couple of patients in cohort eight and we think cohort eight likely the last cohort.
Justin Walsh: As a maximum feasible dose.
Marc H. Hedrick: In Phase 1. In Phase 1, exactly.
Justin Walsh: Phase, one and phase one exactly.
And then in terms of the phase III.
Justin Walsh: So that's a total of 34 patients.
Marc H. Hedrick: And then, in terms of Phase 2, we said that there were a total of 34 patients. And, you know, we think that depending on what meeting we're at, we think we'll have a meaningful update. Our goal, as I said, to get all of those patients enrolled this year. I think that'll be a halfway to do that, and adding three additional sites should help us. So that should give you an idea of kind of what we're looking at from GBM and LM.
Justin Walsh: And.
Justin Walsh: We think that.
Justin Walsh: Depending on what meeting we're at we think will have a meaningful update our goal as I said to get all of those patients enrolled this year I think that'll be it.
Justin Walsh: Half way to do that and adding three additional sites should help us so that should give you an idea of kind of what we're looking at from from GBM from El Limn.
Justin Walsh: So kind of.
Marc H. Hedrick: So kind of reverting back to previous guidance. So the FDA originally did cohorts one through three, and then we had to go back and do part B, which they approved, which was cohorts four to seven. We think cohort seven is probably at the upper end of what is likely to be a safe dose with a single administration. So, as I mentioned today, we're at the dose of the first three patients and are the three patients required in cohort five.
Justin Walsh: Reverting back to previous guidance. So the FDA. We originally did cohorts one through three and then we had to go back and do a part b, which they approved which was cohorts four to seven.
Justin Walsh: Think cohort seven is probably at the upper end.
What is likely to be a safe dose with a single administration.
Justin Walsh: So as I mentioned today, we are the dose the first three patients in.
Justin Walsh: Are the three patients are required in cohort five so we have a couple of stopping points that are required as part of the trial with the FDA, but I think I think there's a good chance, we'll get through all of those cohorts, whether we get a DLT.
Marc H. Hedrick: So we have a couple of stopping points that are required as part of the trial with the FDA, but I think there's a good chance we'll get through all of those cohorts, whether we get a DLT in one of those cohorts or multiple DLTs that cause us to take that as the recommended phase two dose. That sort of still remains to be seen. I will say that we are at.
Justin Walsh: One of those cohorts are multiple deal dlt's it.
Justin Walsh: Cause us to take that as the Rex.
Justin Walsh: Recommended phase II dose that sort of still remains to be seen.
Justin Walsh: I will say that.
Justin Walsh: We are at.
Marc H. Hedrick: Some of the previous cohorts where we've just escalated, we've done our three patients, not had a safety issue, and moved forward. We've now gone back and backfilled some of those cohorts to maintain momentum in the trial because the demand for the product for these patients is so enormous. So we have an obligation, I think, to try to treat as many patients as we can, the FDA will allow. And as I mentioned also, the demand for additional Compassionate Use Doses continues to escalate, and it's actually stretching our resources a bit across the board.
Justin Walsh: Under the previous cohorts, where we've dose escalated we've done our three patients not had a safety issue move forward. We've now gone back and backfill some of those cohorts to maintain momentum in the trial because the demand for the product for these patients is so enormous so we have an obligation I think to try.
Justin Walsh: To treat as many patients as we can the.
Justin Walsh: The FDA will allow and as I mentioned also the demand for additional.
Justin Walsh: Compassionate use doses as continues to escalate.
Justin Walsh: Actually <unk>.
Stretching our resources are bad across the board.
Marc H. Hedrick: But by going back and enrolling additional cohorts and finishing them out to six patients each, it allows us to collect additional safety data that we think will be overall beneficial for the overall program. So that's a lot. I'll stop there and see if you have any follow-up.
Justin Walsh: But by going back and.
Justin Walsh: Rolling additional cohorts and finishing them out to six patients each and allow us to collect additional safety data that we think will be overall beneficial for the overall program. So that's a lot I'll stop there and see if you have any follow up.
Justin Walsh: Great. Yeah, no, that's perfect. One more for me. It's pretty obvious that you guys are, I think, quite confident in rhenium-obispamate as potential for GBM and LM. I'm kind of wondering what the key clinical questions are for the asset at this point, of course, beyond having to, of course, meet the endpoints in any of your current and upcoming trials.
Great, Yes, that's perfect one one more for me.
Speaker Change: Pretty obvious that you guys are quite confident in.
Speaker Change: Premium Obispo made us potential in GBM and.
Speaker Change: I kind of wondering what you believe the the key clinical questions are for the asset.
Speaker Change: At this point of.
Speaker Change: Of course beyond having to of course meet.
Speaker Change: At the end points.
Speaker Change: Any of your current and upcoming trials.
Marc H. Hedrick: You know, that's a great question. And it's probably different for each of those two indications. And you could probably expand that to whether you're treating a solid tumor in the brain or spinal cord. That could be, you know, primary GBM, secondary GBM, or brain mets, or whether you're treating something in the CSF.
Speaker Change: That's a that's a.
Speaker Change: That's a great question and.
Speaker Change: It's probably different for each.
Speaker Change: Each of those two indications and you could probably expand that to whether you are treating.
Speaker Change: Our solid.
Speaker Change: The tumor in the brain or spinal cord that could be primary GBM secondary GBM or <unk>.
Speaker Change: Our brain Mets or whether you are treating something in the in the CSF. So as it relates to a solid mass in the.
Marc H. Hedrick: So as it relates to a solid mass in the brain or spinal cord, ultimately, the key issue is delivery and absorbed dose. And I alluded to this in my remarks, but there is interest amongst partners and potential partners to expand that to other indications in the CNS and compete where EBRT is sort of an established anchor. And the key to that is case planning and delivery. And I think the drug is there developmentally, and we've shown it to be safe, even in large volumes and high radiation doses.
Speaker Change: In the brain and spinal cord ultimately.
Speaker Change: The key issue is delivery and absorbed dose and I alluded to this in my remarks, but there is there is interest amongst partners and potential partners to expand that to other indications in the CNS and compete where <unk> is sort of.
Speaker Change: <unk> anchor and the key to that is case planning.
Speaker Change: And delivery and I think I think the drug as their developmentally and we've shown that to be safe and even in large volumes and high radiation doses the.
Marc H. Hedrick: The question is, how do we optimize delivery? I think we know how to do that. Now it's the question of building out case planning and software tools that can make that happen. So that's how I would characterize that answer as it relates to those two. The other is CSF, and I think that's a different issue. Delivery is easy.
The question is how do we optimize delivery I think we know how to do that so now there the question of building out case.
Speaker Change: Case planning and software tools that can make that happen. So that's how I would characterize that answer as it relates to to those indications.
Speaker Change: The other is CSF and I think thats a different issue deliveries is easy it's a 32nd procedure in the clinic. The question is what's the dose and whats the dosing profile, how many times can these patients tolerate that and.
Marc H. Hedrick: It's a 30-second procedure in the clinic. The question is, what's the dose, and what's the dosing profile? How many times can these patients tolerate that? And I don't think that's a mystery, just like with GBM. I think we've solved the mystery as it relates to case planning. We just need to implement it. I think we've solved the mystery as to whether the drug stays in the CSF and works, the use the kind of archaic language that Dr. LaFrance loves, fractionate that. How do we take that dose and fractionate it over time so we can either suppress or cure LM patients? I think that's the key clinical question there. Long answer, sorry. No, no, no problem.
Justin Walsh: Yeah, no, no, no problem. Very, very enlightening. Thanks for taking the time to answer the question. Thank you.
Speaker Change: I don't think I don't think Thats, a mystery just like with <unk> I think we solve the mystery as it relates to case planning, we just see the implemented I think we've solved the mystery as to whether the drug stays in the CSF and works. The question is how do you.
Speaker Change: They use kind of archaic language that doctor.
Speaker Change: Where France labs, fractionate that how do we take that that dose and fractionated over time, so either suppress our care <unk> patient.
Speaker Change: I think thats the key clinical question there.
Speaker Change: Long answer sorry got it yes, no no no problem very very enlightening. Thanks for taking my question.
Speaker Change: Thank you.
Speaker Change: Thank you one moment for our next question.
Speaker Change: Yes.
Operator: Thank you. One moment for our next question. Our next question comes from Edward Woo from Ascendiant Capital. Your line is open. Yeah, congratulations on all the progress, Mike.
Our next question comes from the line of Edward Woo from <unk> Capital. Your line is open.
Edward Moon Woo: Yes, congratulations on all the progress my question, specifically is on that $3 million grant from the U S. Department of Defense, you said that it's only to cover phase one in pediatric brain cancer is there any opportunities to expand that beyond the phase one funding.
Edward Moon Woo: Hi, this is Norman LaFrance. Good question. And yeah, the short answer is yes. And we're not at liberty to comment about that, but we are cautiously optimistic there'll be other funding capabilities to either accelerate phase one beyond a single site and to get additional funding for our own funding once those preliminary data are known. Given the adult data and given what we're hearing from the pediatric neuro-oncologists and pediatric neurosurgeons, they're pretty optimistic that we'll get the same platform of benefit that we're seeing in adults and be able to move forward in children.
Norman: Hi, This is Norman.
France good question.
Speaker Change: And yes, the short answer is yes.
Speaker Change: And we're not at Liberty.
Speaker Change: Liberty to comment about that but we are cautiously optimistic there'll be other funding capabilities to either accelerate the phase one.
Speaker Change: And the single site.
Speaker Change: And to get additional funding for our own financing once those preliminary data are known.
Speaker Change: Given the adult data.
Speaker Change: And given what we're hearing from the pediatric neuro oncologists and pediatric neurosurgeons.
Speaker Change: They're pretty optimistic that we will get the same platform of benefit that we're seeing in adults.
Edward Moon Woo: So your point of what's after phase one in terms of our interest and our potential resources and funding capability. We already have some funding options in play. I don't mean to be coy, but we're not at liberty to go over those now.
Speaker Change: And be able to move forward in children. So your point of what's what's after the phase one in terms of our interest and our potential resource and funding capability.
Speaker Change: We already have some some funding options in play.
I don't mean to be coy, but we're not at Liberty to go over those now but again, we're cautious cautiously optimistic as Mark has mentioned that those are developing.
Norman D. LaFrance: But again, we're cautiously optimistic, as Marc has mentioned, that these are developing. And we already have a very good platform for phase one and one of the premier sites in this area. And I would see expanding the number of sites to accelerate completion of phase one and going into phase two as quickly as possible.
Speaker Change: And we already have a very good platform for the phase one and one of the Premier sites in this area and I would see expanding the number of sites to accelerate completion of phase, one and going into a phase III as quickly as possible.
Speaker Change: Thanks.
Edward Moon Woo: Thanks. Great. Thanks for answering my questions, and I wish you guys good luck.
Speaker Change: Great. Thanks for taking my questions.
Speaker Change: Good luck. Thank you.
Operator: Thank you. Thank you. Thank you. One moment for
Thank you thanks Edwin.
Operator: Thank you. One moment for our next question. Our next question will come from the line of Sean Lee from HCA Wainwright. Your line is open.
Speaker Change: Thank you one moment for our next question.
Speaker Change: Our next question will come from the line of Sean Lee from H C. Wainwright. Your line is open.
Sean Lee: Hi, good afternoon, guys, and thanks for taking my questions. My first one is on the upcoming Respect LLM updates. So in your prepared remarks, you mentioned that you are expected to present those updates at quite a few conferences this year. So I was wondering whether there are any qualitative differences between the type of data that you're looking to present. For example, what can we expect to see at the Society for Nuclear Medicine meeting in June versus what we can expect to see at the SNO-ASCO meeting in August?
Hi, good afternoon, guys and thanks for taking my questions.
Sean Lee: My first one is on the upcoming respect him.
Sean Lee: <unk> so in the prepared remarks, you mentioned an IV.
Sean Lee: You already expected too.
Sean Lee: Present, those updated quite a few conferences. This year. So I was wondering whether there are any.
Sean Lee: Qualitative differences to the type of data that youre looking to present.
Sean Lee: For example.
Sean Lee: What can we see it.
Sean Lee: Our society for nuclear Medicine meeting in June versus what we can expect to see us in Alaska meeting in August.
Marc H. Hedrick: Hey, Sean, it's Marc. Yeah, good. Thanks for prompting us to clarify that, too. The SN-MMI presentation will largely be a re-presentation of data already presented. And the rationale for doing that there is that, Norman reminded me, it's one additional cohort. The rationale for that is that we've really got three audiences here. We've got the nuclear medicine doctors, we've got the neuro-oncologist, and we've got the neurosurgeons who put the Amaya Reservoirs in.
Mark: Hey, Sean its mark yes.
Mark: Thanks.
Mark: Prompting us to clarify that so.
Speaker Change: The <unk> presentation.
Speaker Change: Largely b E.
Speaker Change: The presentation of data already presented and the rationale for doing that there.
Speaker Change: Is that.
Norman: Norman reminded me, it's one additional cohort.
Speaker Change: The rationale for that is we've really got three.
Speaker Change: Audiences here, we've got the nuclear medicine doctors, we've got the neuro oncologist and we've got the neurosurgeons, who put the EMI reservoirs and so it's just it's really important we think long term for getting that data in front of those key constituencies. So it allow us to go back and present that data to the.
Marc H. Hedrick: So it's really important, we think, in the long term, for getting that data in front of those key constituencies. So it'll allow us to go back and present that data to the NUC-MED physicians. The Snow-ASCO presentation on LM will be an update on enrollment, and also on safety. And that will be as of that time. But we won't get into points of efficacy, cell count, and so forth.
Speaker Change: To the new med.
Speaker Change: <unk>.
Physicians the snow ASKO presentation on <unk> will be a update of enrollment.
Speaker Change: And also on safety and that'll be as of that time, but we won't get into.
Speaker Change: Points of efficacy.
Speaker Change: Cell count and so forth snow will really be I think a more definitive presentation that will be in November by that time I think there is a chance that the phase one will be completely enrolled.
Marc H. Hedrick: Snow will really be, I think, a more definitive presentation. That will be in November. By that time, you know, I think there's a chance that Phase I will be completely enrolled, and we'll have some more meaningful data to discuss at that point. So that's the data plan. And then, just as I think I mentioned this in my remarks, also at SNMMI, we'll be talking about the dosimetry data. And that's a group that really appreciates that data, and we'll be able to provide that and get academic feedback at that.
Sean Lee: Great, that makes it a lot more clear. Thanks.
Speaker Change: And we'll have some more meaningful data to discuss at that point. So that's the data plan.
Speaker Change: And then I think just as I think I've mentioned this in my.
Speaker Change: Mark's also at Sn EMI, we'll be talking about the dosimetry data and that's a group that really appreciates that data and we'll be able to provide that and get academic feedback at that meeting.
Sean Lee: And my second question is about the pediatric study. So have you decided on the dosing regimen for use in that? As I know, the FDA tends to be pretty strict in these trials.
Speaker Change: Great that makes it a lot more clear thanks and my second question is on the pediatric study so.
Speaker Change: Have you decided on doing dosing regimens, we use for that is I know asking tend to be at.
Speaker Change: Pretty strict on these.
Speaker Change: And trials.
Norman D. LaFrance: Yeah, this is Norman. I'll take that one.
Speaker Change: Yes. This is normal.
Speaker Change: That one.
Speaker Change: And.
Speaker Change: Very appropriate question.
Mark: I think Mark made this clear that we have already had a couple of iterations with FDA.
Mark: And I think it's fair to say, we basically have the protocol approved in principle right down to the dosing, we have basically broken down as <unk>.
Mark: Comparable to how we did <unk> that we had the initial cohorts with lowered.
Norman D. LaFrance: And a very appropriate question. We've, and I think Marc made this clear that we've already had a couple of iterations with FDA. And I think it's fair to say we basically have the protocol approved in principle, right down to the dosing. We have it basically broken down, and it's comparable to how we did LM, that we had the initial cohorts with lower In the pediatric situation, because ependymomas can be large, we're starting off with small, small... tumors, and there'll be both a volume and administered dose definition that the FDA has accepted.
Mark: And the pediatric situation, where because <unk> can be large we're starting off with small small.
Mark: Tumors and there'll be both a dissimilar to GBM volume administered dose.
Mark: <unk>.
Mark: Definition that the FDA has accepted.
Mark: Okay.
Norman D. LaFrance: I very clearly state the FDA very much liked the idea of our breaking up the pediatric phase one and the two segments, the small and medium-sized tumors, reviewing those, and then LM with the first initial cohorts to give FDA comfort on what we're seeing, the safety profile, how well it's tolerated. And once they saw that in LM, they were, you know, gangbusters for us proceeding for cohorts four through seven.
Mark: Very clearly state the FDA very much like the idea of our breaking up the pediatric phase one and the two segments to small and medium sized tumors reviewing those.
Mark: Okay.
Mark: We did with <unk> with the first initial cohorts to give FDA comfort on what we're seeing this safety profile, how wallets tolerated and once they saw that they were gangbusters for us proceeding for cohorts four through seven we took that success and applied it to the pediatric <unk>.
Norman D. LaFrance: We took that success and applied it to the pediatric interactions with FDA and got a similar unanimous acceptance of the pediatric trial. We essentially are waiting, you know, for this DOD grant submission and now funding, which we're very appreciative of. He will, you know, now send in the formal IND. We didn't want to get that in and then have it languish, waiting for funding and having to work around that.
Mark: Our actions with FDA and got a similar unanimous acceptance of the pediatric trial and we essentially are waiting we are waiting for this Dod grant submission and now funding, which we're very appreciative.
Mark: Tools now send in the formal IND, we didn't want to get that in and then habit languish Wade.
Waiting for funding and having to work around that and FDA knew that and there's some final.
Norman D. LaFrance: And the FDA knew that. And there's some final. I'll call them housekeeping questions. We'll take care of that. But I want to emphasize the dosing, which will be a function and it's beyond the scope of this call, and we can deal with it offline if you really want to get into the study design, but it'll be volume and administered dose, um, uh, escalation, um, you know, and with very strong core collaboration with the Lurie, uh, neuro-oncologists and neurosurgical folks. We're Thank you. And, and.
Mark: I'll call. It housekeeping questions, we will take care of with that but I want to emphasize the dosing, which will be a function and is beyond the scope of this call and we can deal with it offline. If you really want to get into the study design, but it'll be a volume and administered dose.
Mark: Escalation.
Mark: And with very strong core collab.
Mark: Collaboration with Hillary Neuro oncologists and neurosurgical folks were very excited about it. Thank you.
Marc H. Hedrick: And Sean, I agree. And I think it'll be scaled to the cranial volume and to the uniqueness of those particular kinds of tumors, high-grade glioma, which tends to be very infiltrative, and ependymoma, which needs to be highly recurrent.
Speaker Change: And Sean.
Sean Lee: I agree and I think it'll be scaled two cranial volume and two.
Speaker Change: The uniqueness of those particular types of tumors high grade glioma, which tends to be very infiltrative independent Mama, which must be highly recurrent.
Sean Lee: I see. Thanks for the clarity on that. That's all the questions I have.
I see thanks for the clarity on that that's all the questions I have.
Speaker Change: Great. Thank you.
Operator: Thank you. And I'm not showing any further questions in the queue. I'd like to turn the call back over to Dr. Hedrick for any closing remarks.
Speaker Change: Thank you and I'm not showing any further questions in the queue I'd like to turn the call back over to Dr. Hedrick for any closing remarks.
Okay.
Marc H. Hedrick: Thank you, everybody, for joining the call. We really appreciate the questions and appreciate your interest in the company. And we're thankful also for our doctors who work with us and the patients that trust us and our employees that help make it happen. So I look forward to talking to you again soon. Thank you.
Marc H. Hedrick: Okay. Thank you everybody for joining the call we really appreciate the questions and.
Marc H. Hedrick: Kate your interest in the company.
Marc H. Hedrick: And we're thankful to also to our.
Marc H. Hedrick: Our doctors, who work with us for the patients that.
Marc H. Hedrick: Trust us and our employees that help make it happen. So look forward to talking to you again soon thank you.
Operator: Thank you for your participation in today's conference. This does conclude the program. You may now disconnect. Everyone, have a great day.
Marc H. Hedrick: Thank you for your participation in today's conference. This does conclude the program you may now disconnect everyone have a great day.
Marc H. Hedrick: Okay.
Marc H. Hedrick: [music].
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Marc H. Hedrick: [music].
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Marc H. Hedrick: Okay.