Q2 2024 Cellectar Biosciences Inc Earnings Call

Speaker Change: Good morning and welcome to Selector Bioscience Second Quarter 2024 Financial Results Call. Today's call is being recorded.

Operator: Order the 2024 Financial Results Call. Today's call is being recorded.

Unknown Executive: Before we begin, I would like to remind everyone that statements made during this call relating to Selector's expected future performance, future business prospects, or future events or plans are forward-looking statements as defined under the Private Securities Litigation Reform Act of 1995. Although the company believes that the expectations reflected in such forward-looking statements are based upon reasonable assumptions, actual outcomes and results are subject to risks and uncertainties that could differ materially from those forecast due to the impact of many factors beyond the control of selectors. The company assumes no obligation to update or supplement any forward-looking statements, whether as a result of new information, future events, or otherwise.

Speaker Change: Before we begin, I would like to remind everyone that statements made during this call relating to selectors' expected future performance

Speaker Change: Future Business Prospects or Future Events or Plans are forward-looking statements as defined under the Private Securities Litigation Reform Act of 1995.

Speaker Change: Although the company believes that the expectations reflected in such forward-looking statements are based upon reasonable assumptions,

Speaker Change: Actual outcomes and results are subject to risk and uncertainties that could differ materially from those forecast due to the impact of many factors beyond the control of selector.

Speaker Change: The company assumes no obligation to update or supplement any forward-looking statements, whether as a result of new information, future events, or otherwise.

Unknown Executive: Participants are directed to the cautionary notes in the 4th April press release, which is available on the Investor Relations portion of the company's website, as well as the risk factors set forth in Cellectar's annual reports filed with the SEC for factors that could cause actual results to differ materially from those anticipated in the forward-looking statement. At this time, I would like to turn the call over to Jim Caruso, President and Chief Executive Officer of Cellectar. Mr. Caruso, please go ahead.

Speaker Change: Participants are directed to the cautionary notes at 4th April press release.

Speaker Change: which is available on the investor relations portion of company's website. As well as the risk factors, set forth in selectors, annual reports filed with the SEC for factors that could cause actual results to differ materially from those anticipated in the forward-looking statements.

Speaker Change: At this time, I would like to turn the call over to Jim Caruso, President and Chief Executive Officer of Selector. Mr. Caruso, please go ahead.

James Caruso: Thank you, operator. And good morning, everyone. It is my pleasure to be here with you to provide a corporate update for our second quarter of 2024. With me today are Dr. Andrei Shustov, Senior Vice President, Medical, Jarrod Longcor, Chief Operating Officer, Shane Lea, Chief Commercial Officer, and Chad Kolean, Chief Financial Officer. I will begin today with a brief recap of our progress over the past quarter and discuss anticipated near-term milestones. I would then ask Chad to provide an update on our financial... Andrei will follow with additional insights regarding our Clover Wham Pivotal Study, followed by Jarrod, who will provide an operations update on the regulatory front and manufacturing. Finally, Shane will review our commercial product, and we will then open the call for Q&A.

Jim Caruso: Thank you operator and good morning everyone. It is my pleasure to be here with you to provide a corporate update for our second quarter of 2024.

Speaker Change: With me today are Dr. Andrei Shustov, Senior Vice President, Medical, Jarrod Longcor, Chief Operating Officer, Shane Lea, Chief Commercial Officer, and Chad Kolean, Chief Financial Officer.

Speaker Change: I will begin today with a brief recap of our progress over the past quarter and discuss anticipated near-term milestones.

Chad Kolean: I will then ask Chad to provide an update on our financials.

Speaker Change: Andrei will follow with additional insights regarding our Clover WAM pivotal study, followed by Jarrod who will provide an operations update on the regulatory front and manufacturing.

Speaker Change: Finally, Shane will review our commercial progress.

Speaker Change: We will then open the call for Q&A.

James Caruso: As you are likely aware, on July 23rd, we announced the full data results from our pivotal trial in WM, which were truly impressive and maintained the potential to meaningfully improve upon the current standard of care in WM. Andrei will discuss the quality of the data in an extremely challenging patient population. However, I'd like to emphasize to everyone that the patients in the clinical trial were by far the most refractory ever studied in this indication, with Iapophisine I-131 representing the fifth most refractory line.

Andrei: As you are likely aware, on July 23rd, we announced our full data results from our pivotal trial in WM, which were truly impressive and maintained the potential to meaningfully improve upon the current standard of care in WM.

Andrei: Andrei will talk through the quality of the data in an extremely challenging patient population. However, I'd like to emphasize to everyone that the patients in the clinical trial were by far the most refractory ever studied in this indication.

Andrei: with iapofacin I-131 representing the fifth median line treatment.

James Caruso: It is therefore impressive to observe comparable results obtained in Clover Wham to those reported in first and second line with other treatments. Of course, our near-term organizational focus remains locked on IFOPACIN's WM regulatory and commercial objectives. Iopropacin has also demonstrated utility in other hematologic indications, such as relapse, refractory multiple myeloma, and DLBCL. And clinical development is ongoing in our Phase 1b for pediatric high-grade glioma. As you may recall, we initiated and enrolled the first patient in this Phase 1B study earlier this year. With iopophicine's ability to cross the blood-brain barrier, we remain excited about the potential it may provide in this high, unmet medical need treatment setting.

Andrei: It is therefore impressive to observe comparable results obtained in Clover Wham to those reported in first and second line with other treatments.

Andrei: Of course, our near-term organizational focus remains locked on IFOPACINE's WM regulatory and commercial objectives.

Andrei: Iopopacin has also demonstrated utility in other hematologic indications such as relapsed refractory multiple myeloma and DLBCL. And clinical development is ongoing in our Phase 1b for pediatric high-grade leomas.

Andrei: As you may recall, we initiated and enrolled the first patient in this Phase I-B study earlier this year. With Iapophicin's ability,

Andrei: To cross the blood-brain barrier, we remain excited about the potential it may provide in this high unmet medical need treatment setting.

James Caruso: We plan to provide a study update in the second half of this year. Beyond Iapopacine, our PDC platform continues to serve as the backbone to our radiotherapeutic franchise. We have now successfully conjugated nearly all available isotopes with our platform, including beta, OG, and alpha emitters, and have completed extensive preclinical proof-of-concept work in each area. We are currently advancing one of our actinium-based conjugates through IND-enabling studies in preparation for phase one in solid tumors.

Andrei: We plan to provide a study update in the second half of this year.

Andrei: Beyond Iopophicine, our PDC platform continues to serve as the backbone to our radiotherapeutic franchise.

Andrei: We have now successfully conjugated nearly all available isotopes with our platform, including beta, OG, and alpha emitters, and have completed extensive preclinical proof-of-concept work in each area.

Andrei: We are currently advancing one of our actinium-based conjugates through IND-enabling studies in preparation for a Phase I in solid tumors.

James Caruso: We continue to focus on completing the work for our NDA filing with plans to submit our filing to the FDA in the fourth quarter. Assuming we are granted priority review associated with our Fast Track designation, we expect a six-month period. Finally! Prior to turning the call over to Chad for greater detail, I would like to emphasize that the 8K filed this past Friday indicating that we are in the process of restating our recent historical financial statements, although unfortunate, does not impact cash or cash burn, and the changes to historical earnings will all be non-operating and non-cash. Chad?

Andrei: We continue to focus on completing the work for our NDA filing with plans to submit our filing to the FDA in the fourth quarter.

Andrei: Assuming we are granted priority review associated with our Fast Track designation, we expect a six-month review.

Andrei: Finally,

Andrei: prior to turning the call to Chad for greater detail.

Speaker Change: I would like to emphasize that the 8K filed this past Friday, indicating that we are in process of restating our recent historical financial statements, although unfortunate

Speaker Change: does not impact cash or cash burn and the changes to historical earnings will all be non-operating and non-cash.

Chad Kolean: Thank you, Jim. Our cashing cash equivalence balance as of June 30, 2024 is $25.9 billion, compared to $9.6 million as of December 31, 2020. Note that at the end of the first quarter, we had a cash balance of $40 million, resulting in the net cash used in operating activities during the second quarter being approximately $14.1 million.

Speaker Change: Chad

Chad Kolean: Thank you, Jim.

Speaker Change: Our cash-in-cash equivalence balance as of June 30, 2024 is $25.9 billion.

Speaker Change: compared to 9.6 million as of December 31, 2023.

Speaker Change: Note that at the end of the first quarter, we had a cash balance of $40 million, resulting in the net cash used in operating activities during the second quarter being approximately $14.1 million.

Chad Kolean: In addition to the cash on hand at the end of June, in July, nearly all of the investors from the September 2023 financing exercised their tranche B warrants at a reduced, as converted, common stock price of $2.52 per share. Those investors who exercised their Trans-Fee Warrants also received new warrants as part of the transaction, which generated gross proceeds of approximately $19.4 million before customary expenses and the company believes its cash on hand, inclusive of the July warrant exercise process, adequate to fund budgeted operations into the second quarter of 2025.

Speaker Change: In addition to the cash on hand at the end of June, in July, nearly all of the investors from the September 2023 financing exercised their Tranche B warrants at a reduced as converted common stock price of $2.52 per share.

Speaker Change: Those investors who exercised their transfer warrants also received new warrants as part of the transaction, which generated gross upfront proceeds of approximately $19.4 million before customary expenses and fees.

Speaker Change: The company believes it's cash on hand, inclusive of the July warrant exercise proceeds.

Speaker Change: is adequate to fund budgeted operations into the second quarter of 2025.

Chad Kolean: The three warrant tranches issued last month provide potential additional funding, based upon their respective expiration dates, which occur with a first tranche of approximately 17 million after we receive a dufidate from the FDA. A second tranche of approximately $32.9 million after we receive approval for Iopopsin I-131 from the FDA, and a third tranche of approximately $23.5 million after the first quarter in which we generate $10 million in revenue from IAPOPC and Iopopsin I-131.

Speaker Change: The three warrant tranches issued last month provide potential additional funding.

Speaker Change: based upon their respective expiration dates, which occur with

Speaker Change: A first tranche of approximately $17 million after we received a PDUFA date from the FDA. A second tranche of approximately $32.9 million after we received approval of ibuprofen I-131 from the FDA.

Speaker Change: And a third tranche of approximately $23.5 million after the first quarter in which we generate $10 million in revenue from IAPOPC and I-131.

Chad Kolean: Assuming our discussions with the FDA go as planned, this funding would get Celectar to the point where it will be cash flow positive. Turning back to the second quarter, R&D expense was approximately $8.2 million, compared to $6.3 million in the second quarter of 2023.

Speaker Change: Assuming our discussions with the FDA go as planned, this funding would get SelectDART to the point where we will be cash flow positive.

Speaker Change: Turning back to the second quarter, R&D expense was approximately $8.2 million compared to $6.3 million in the second quarter of 2023.

Chad Kolean: The increase is largely driven by the timing of expenditures for our WM pivotal trials for patient's final visits and performing the extensive analytical work necessary to complete the NDA submission. We've also continued investing substantially in our Product Sourcing, Manufacturing, and Logistics Infrastructure by developing multiple sources for each aspect of hypotheses production. GNA expense for the second quarter of 2024 was $6.4 million, compared to $2.0 million last year.

Speaker Change: The increase is largely driven by the timing of expenditures for our WM pivotal trials for patients final visits and perform the extensive analytical work necessary to complete the NDA submission.

Speaker Change: We have also continued investing substantially in our product sourcing, manufacturing, and logistics infrastructure by developing multiple sources for each aspect of IAPAPAC production.

Speaker Change: The G&A expense for the second quarter of 2024 was $6.4 million compared to $2.0 million last year.

Chad Kolean: The Incremental Spend is focused on the establishment of the necessary commercialization capability to support product sales upon our expected 2025 NDA approval. As Jim stated earlier, We filed an 8K with the SEC indicating that we are in the process of restating our historical financial statements for fiscal years 2022 and 2023, precipitated by a reevaluation of the accounting for the warrants issued in October 2022. At the time they were issued, the warrants were classified as assets. This was based on our assessment, which was supported by third-party expert evaluation. We now believe they should be classified as liabilities.

Speaker Change: The synchronous spend is focused on the establishment of the necessary commercialization capabilities.

Speaker Change: to support product sales upon our expected 2025 NDA approval.

Jim Caruso: As Jim stated earlier...

Speaker Change: We filed an 8K with the SEC, indicating that we are in the process of restating our historical financial statements for fiscal years 2022 and 2023 in the first quarter of this year.

Speaker Change: This was precipitated by a reevaluation of the accounting for the warrants issued in October 2022.

Speaker Change: At the time they were issued, the warrants were classified as equity. This was based on our assessment, which was supported by third-party expert evaluation.

Chad Kolean: Associating a revision in our historical earnings, While previously reported earnings will be modified, the restatement does not impact cash or cash burned, and the changes to historical earnings will all be non-operating and non-cash. The work required to restate the historical results is in process and must be completed before we can file the second quarter 10-Q, which delays the 10-Q filing. We are performing this work as rapidly as possible, and while we do not have a definite target date for completion, we expect it will take approximately... With that, I will now turn the call over to... Thank you, Chad, and good morning, everyone.

Speaker Change: We now believe they should be classified as liabilities.

Speaker Change: necessitating a revision in our historical reporting.

Speaker Change: While previously reported earnings will be modified, the restatement does not impact cash or cash burn, and the changes to historical earnings will all be non-operating and non-cash.

Speaker Change: The work required to restate the historical results is in process and must be completed before we can file Section Quarter 10-Q, which delays the 10-Q filing.

Speaker Change: We are performing this work as rapidly as possible, and while we do not have a definite target date for completion, we expect it will take approximately six weeks.

Speaker Change: With that, I will now turn the call over to Andrei.

Andrei Shustov: Recently, we provided an update on the top-line results from our pivotal Global WAMP study that is fully enrolled with all living patients who have completed study treatment remaining in long-term follow-up. There are 65 patients in the safety data set, defined as all patients receiving at least one dose of Iapophisin I-131. And there are 55 patients who met the criteria for inclusion in the efficacy evaluable set, defined as all patients who have received at least 60 millicurie total administered dose and have undergone at least one response assessment.

Andrei: Thank you, Chad, and good morning, everyone.

Andrei: Recently, we provided an update on the top-line results from our pivotal global WAMP study that is fully enrolled with all living patients who have completed study treatment remaining in long-term follow-up.

Speaker Change: There are 65 patients in the safety data set, defined as all patients receiving at least one dose of Iapophisin I-131.

Speaker Change: And there are 55 patients who met the criteria for inclusion in the efficacy evaluable set defined as all patients who have received at least 60 millicurie total administered dose and have undergone at least one response assessment.

Andrei Shustov: The response rates and safety data discussed today are as of May 31st, 2024, the data cutoff date. As a reminder, CLOA-WAMP is a global, single-arm, phase 2b study examining hypothesin I-131 in relapsed and refractory patients who have received at least two prior lines of therapy, including those patients who failed or had a suboptimal response to BTKI, the only FDA Study patients received a total of four doses of Ipofacin I-131 over two cycles, without maintenance or retreatment, and were evaluated for response at regular protocol-defined intervals using standard IWWM criteria.

Darak Kadov: The response rates and safety data discussed today are as of May 31, 2024 data cutoff date.

Darak Kadov: As a reminder,

Speaker Change: Klovalam is a global single arm faced to be studied, examining eye-ophoficent eye-one 31 in relapsed and refractory patients.

Darak Kadov: who have received at least two prior lines of therapy, including those patients who failed or had suboptimal response to BTKI, the only FDA-approved class of treatment for this cancer.

Darak Kadov: Study patients received a total of four doses of Iopofacin I-131 over two cycles.

Darak Kadov: without maintenance or retreatment and were evaluated for response at regular protocol-defined intervals using standard IWWM criteria.

Andrei Shustov: As Jim stated, patients enrolled in CLOA-WAMP were the most heavily pre-treated and the most refractory WM patient population ever reported in clinical trials. Please allow me to review a few key patient and disease characteristics. The median age was 70 years, with the oldest enrolled patient aged 88 years.

Darak Kadov: As Jim stated, patients enrolled in CLOA-WAMP were the most heavily pre-treated and the most refractory WM patient population ever reported in clinical trials.

Andrei Shustov: The median number of prior therapies was four, with a range from 2 to 14. 71% of patients were previously treated with BTKI, 91% were treated with rituximab, and 84% received prior multi-agent chemotherapy.

Speaker Change: Please allow me to review a few key patient and disease characteristics.

Jim Caruso: The median age was 70 years with oldest enrolled patient aged 88 years.

Speaker Change: The median number of priority reviews was 4.

Speaker Change: with a range from 2 to 14.

Speaker Change: 71% of patients were previously treated with BTKI, 91% were treated with reduced SNAP, and 84% received prior

Andrei Shustov: Over 90% of patients were refractory to at least one class of drugs, with refractories to BTKI reported in 67 percent, to rituximab in 60 percent, and to chemotherapy in 56 percent of patients exposed to those treatments. Additionally, 40% of all patients in the efficacy set were considered dual-class refractory, including VTKI and rituximab, and 27% were triple-class Further, more than half or 55% of global WAM patients in the efficacy-valuable set were conceded median or high risk based on the ITSS WM score, which is a recognized negative prognostic factor for progression-free survival and overall survival in WM patients treated with available therapy. Finally, approximately 30% were found to have the wild-type MITAD8 gene, a known genomic factor that confirmed resistance to BTKI therapy.

Speaker Change: Over 90% of patients were refractory to at least one glass of drugs.

Speaker Change: With a refractorance to BTKI reported in 67% to retook simap in 60% and to chemotherapy in 56% of patients exposed to those treatments.

Unknown Executive: 2424 Financial Results Call Today's call has been recorded. Before we begin, I would like to remind everyone that statements made during this call relating to selectors expected future performance, future business prospects, or future events or plans are forward-looking statements as defined under the private securities litigation reform act of 1995. Although the company believes that the expectations reflected in such forward-looking statements are based upon reasonable assumptions, actual outcomes, and results are subject to risk and uncertainties that could differ materially from those forecasts due to the impact of manufacturers beyond the control of the sector.

Speaker Change: 40% of all patients in the efficacy set were considered dual class refractory including VTKI and rituximab and 27% were triple class refractory including VTKI, rituximab, and chemotherapy.

Unknown Executive: The company assumes no obligations to update or complement any forward-looking statements whether as a result of new information, future events, or otherwise. Participants are directed to the cautionary notes that forward annual press release, which is available on the Investor Relations portion of company's website, as well as there is factors that forward and selectors annual reports filed with the SEC for factors that could cause actual results to differ materially from those anticipated in the forward-looking statements.

Speaker Change: Further.

Speaker Change: More than half, or 55%, of global WAM patients in an efficacy-valuable set.

Speaker Change: were conceded median or high risk based on ITSS WM score, which is a recognized negative prognostic factor for progression pre-survival and overall survival in WM patients treated with available therapies.

Speaker Change: Finally, approximately 30% were found to have wild-type MI-D88 gene and known genomic factor confirmed resistance to PTKI therapy.

Andrei Shustov: Now, let me briefly review key efficacy results. A hypophysin I-131 demonstrated an impressive and clinically relevant 80% overall response rate and 98.2% clinical benefit rate. This is highly meaningful for this elderly patient population with an incurable malignancy. Annual reduction in tumor burden, or even disease stability, brings clinical benefit, improves symptoms, and extends progression-free survival and time off treatment. The major response rate, defined as partial response or better, was 56.4%, significantly exceeding the protocol-defined primary endpoint statistical hurdle of 20%.

Speaker Change: Now, let me briefly review key efficacy results.

Speaker Change: Hypophasin I-131 demonstrated an impressive and clinically relevant 80% overall response rate and 98.2% clinical benefit rate.

Speaker Change: This is highly meaningful for this elderly patient population with an impurable malignancy.

Speaker Change: For these patients, any reduction in tumor burden, or even disease stability, brings clinical benefit, improves symptoms, and extends progression-free survival and time-off treatment.

James Caruso: At this time, I would like to turn the call over to Jim Caruso, President and Chief Executive Officer of Selector. Mr. Caruso, please go ahead. Thank you, operator, and good morning, everyone. It is my pleasure to be here with you to provide a corporate update for our second quarter of 2024. With me today, our Dr. Andre Shustoff, Senior Vice President, Medical, Jared Longcore, Chief Operating Officer, Shane Lee, Chief Commercial Officer, and Chad Pulling, Chief Financial Officer.

Speaker Change: The major response rate, defined as partial response or better, was 56.4%, significantly exceeding the protocol-defined primary endpoint statistical hurdle of 20%.

Andrei Shustov: We're also excited to report that in line with our previous observation and reported trends in late responses after Ipofacin therapy, an additional partial response was registered after the latest data cutoff, effectively bringing the MRR to 58.2%. As follow-up of study patients continues, we might expect further improvement in the major response rate due to delayed response. Further, the data show a 7.3% complete response or very good partial response rate in a patient population in which CRs have not been previously observed or reported.

Speaker Change: We're also excited to report

Speaker Change: that in line with our previous observation and reported trends in late responses after iapophysin therapy, an additional partial response was registered after the latest data cut off, effectively bringing the MRR back to normal.

James Caruso: I will begin today with a brief recap of our progress over the past quarter and discuss anticipated near-term milestones. With NDS Chad, provide an update on our financials. Andre will follow with additional insights regarding our Clover Wham Pivotal Study, followed by Jared who will provide an operations update on the regulatory front and manufacturing. Finally, Shane will review our commercial progress.

Speaker Change: to 58.2%.

Speaker Change: As follow-up of study patient continues, we might expect further improvement in major response rate due to delayed response.

Speaker Change: Further, the data show the 7.3% complete response or very good partial response rate in a patient population in which CRs have not been previously observed or reported.

James Caruso: We will then open the call for Q&A. As you are likely aware, on July 23rd, we announced our full data results from our Pivotal trial in WN, which were truly impressive and maintained the potential to meaningfully improve upon the current standard of care in WN. Andre will talk to the quality of the data in an extremely challenging patient population. However, I'd like to emphasize to everyone that the patients in the clinical trial were by far the most refractory ever studied in this indication.

Andrei Shustov: I would also like to highlight the observed high response rate to hypothesis in highly refractory and challenging-to-treat patient subpopulations. First, among patients with MIGHTY88 wild-type tumors that are inherently resistant to BTKI therapy, the overall response rate was 81%. And among those previously treated with BTKI, the overall response rate was 72%. In patients with tumors refractory to both VTKi and rituximab or dual refractory, the overall response rate was 65%, and in those with tumors refractory to BTKI, rituximab, and multiple chemotherapy agents, or triple refractory, which are patients with no available treatment options. The overall response rate was 54%.

Speaker Change: I would also like to highlight the observed high response rate to hypophasin.

Speaker Change: in highly refractory and challenging-to-treat patient subpopulations.

Speaker Change: First, among patients with MIGHTY88 wild-type tumors that are inherently resistant to BTKI therapy.

Speaker Change: the overall response rate was 81%. And among those previously treated with BTKI, the overall response rate was 72%.

James Caruso: With IOPOficine I-131 representing the fifth median-lined treatment, it is therefore impressive to observe comparable results obtained in Clover Wham through those reported in first and second-line with other treatments, of course, our near-term organizational focus remains locked on Iopopicine's WM regulatory and commercial objectives. Iopopicine has also demonstrated utility in other hematologic indications such as relapse, refractory multiple myeloma, N-D-L-B-C-L, and clinical development is ongoing in our phase 1-B for pediatric high grade leomas.

Speaker Change: In patients with tumors refractory to both VTKI and rituximab or dual refractory, the overall response rate was 65 percent.

Speaker Change: and in those with tumors refractory to BTKI, rituximab, and multiple chemotherapy agents, or triple refractory.

Speaker Change: which are the patients with no available treatment options. The overall response rate was 54%.

Andrei Shustov: Seeing these rates of responses in highly refractory patient populations is very impressive, and we believe that physician's hypothesis as the standard of care for relapsed refractory patients and for development in early lines of therapy. The duration of clinical benefit is critical for elderly patients with WM.

Speaker Change: Seeing these rate of responses in highly refractory patient population is very impressive and we believe it positions iapopacin as the standard of care for relapsed refractory patients and for development in earlier lines of therapy.

Speaker Change: The duration of clinical benefit is critical for elderly patients with WM.

James Caruso: As you may recall, we initiated and enrolled the first patient in this phase 1-B study earlier this year. With Iopopicine's ability to cross the blood brain barrier, we remain excited about the potential it may provide in this high, unmet medical need treating setting.

Andrei Shustov: The treatment-free survival enabled by Ipofacin I131 fixed course of therapy is in sharp contrast with continuous or maintenance therapy approaches currently utilized with FDA-approved agents and significantly improves patients' quality of life. Durability of responses in ClovaWamp was assessed on 41 overall responders and 26 major responders at the data cutoff date of March 7, 2024, with a median follow-up of 8.8 months. This did not include four additional overall responses and five additional major responses recorded at the latest cutoff date of May 31st, 2024.

Speaker Change: The treatment-free survival enabled by Ipofacin I-131 fixed course of therapy is in sharp contrast with continuous or maintenance therapy approaches currently utilized with FDA-approved agents.

James Caruso: We plan to provide a study update in the second half of this year. Beyond Iopopicine, our PDC platform continues to serve as the backbone to our radio therapeutic franchise. We have now successfully conjugated nearly all available isotopes with our platform, including beta, OG, and alpha emitters, and have completed extensive pre-clinical proof of concept work in each area. We are currently advancing one of our actinium-based conjugates through IND enabling studies and preparation for phase 1 in solid tumors.

Speaker Change: and significantly improves patients' quality of life.

Speaker Change: Durability of responses in ClovaWamp were assessed on 41 overall responders and 26 major responders at the data cutoff date on March 7, 2024.

Speaker Change: with a median follow-up of 8.8 months that did not include four additional overall responses and five additional major responses recorded at the latest cutoff date of May 31st, 2024.

Andrei Shustov: The median duration of response and median progression-free survival were not breached, with an estimated 72% of patients with overall response and 78% of patients with major response remaining progression-free at 18 months. This is in sharp contrast with our findings using data extracted from community-based oncology providers indicating that among those, approximately 10% responders in the third-plus line of therapy.

Speaker Change: The median duration of response and median progression-free survival were not breached, with an estimated 72% of patients with overall response and 78% of patients with major response remaining progression-free at 18 months.

James Caruso: We continue to focus on completing the work for our NDA filing with plans to submit our filing to the FDA in the fourth quarter. Assuming we are granted priority review associated with our fast track designation, we expect a six-month review.

Speaker Change: This is in sharp contrast with our findings using data extracted from community-based oncology providers indicating that among those approximately 10% responders in third-plus line of therapy

Chad Kolean: Finally, prior to turning the call to chat for greater detail, I would like to emphasize that the 8K filed this past Friday indicating that we are in process of restating our recent historical financial statements, although unfortunate, does not impact cash or cash burn and the changes to historical earnings will all be non-operating and non-cash. Chat, thank you Jim. Our cash and cash equivalence balance, as of June 30, 2024, is $25.9 billion, compared to $9.6 million as of December 31, 2023.

Andrei Shustov: The duration of response is expected to be around six months. We anticipate that as our data matures, the durability enabled by phone, the 80% overall response, and the 58% major response rate will continue to improve and position Iapophicin as an attractive option in the WL treatment landscape, assuming FDA approval. To put Clover WAM efficacy results into clinical practice, it is our belief that while MRR is an important endpoint that satisfies the study primary objective threshold and positions iapophicin favorably for regulatory approval, and VGPR-CR are important research endpoints that support iapophicin as a disease-modifying therapy.

Speaker Change: The duration of response is expected to be around six months.

Speaker Change: We anticipate that as our data matures, the durability enabled by both the 80% overall response

Speaker Change: and a 58% major response rate will continue to improve and position Iapophicin as an attractive option in WEL treatment landscape, assuming FDA approval.

Speaker Change: To put Clover WAM efficacy results into clinical practice perspective, it is our belief that while MRR is an important endpoint that satisfies the study primary objective threshold and positions IAPOFIS in favorably for regulatory approval.

Chad Kolean: Note that at the end of the first quarter, we get a cash balance of $40 million, resulting in the net cash use and operating activities during the second quarter, being approximately $14.19. In addition to the cash on hand at the end of June, in July, nearly all of the investors from the September 2023 financing exercised their tronchvy balance at a reduced as converted common stock price of $2.52 per share. Those investors who exercised their tronchvy balance also received new balance as part of the transaction, which generated gross approach proceeds of approximately $19.4 million.

Speaker Change: And the BGPR-CR are important research endpoints that support hypothesis as disease-modifying therapy.

Andrei Shustov: It is the overall response rate and clinical benefit rate combined with impressive durability and time of treatment that will drive treatment decisions in favor of Iapophisin and the management of this challenging patient population. A hypophysin I-131 was well-tolerated in this vulnerable, elderly patient population possessing multiple age-related comorbidities, with their bone marrow compromised by cancer and multiple prior toxic therapies. The observed safety profile remains consistent with previously reported data. Grade three or higher, treatment-emerging adverse events occurring in more than 10% of patients in a safety population with an N of 65 were thrombocytopenia, 80%, neutropenia, 69.2%, anemia, 44.6%, lymphopenia, 13%, and all infection, 12.3%. There were no reported opportunistic or invasive fungal infections observed in the study patients.

Speaker Change: It is the overall response rate and clinical benefit rate combined with impressive durability and time of treatment that will drive treatment decisions in favor of hypothesis and the management of this challenging patient population.

Speaker Change: A hypophysin I-131 was well tolerated in this vulnerable elderly patient population possessing multiple age-related comorbidities with their bone marrow compromised by cancer and multiple prior toxic therapies.

Chad Kolean: Before a customary expenses and fees, the company believes its cash on hand, inclusive of the July warrant exercised proceeds, is added to fund budgeted operations into the second quarter of 2025. The three warrant tranches issued last month provide potential additional funding based upon their respective expiration dates, which occur with a first tranche of approximately 17 million at the re-receive at the duvet date in the FDA, a second tranche of approximately 32.9 million at the re-receive approval of iPop scene I-131 from the FDA, and a third tranche of approximately 23.5 million at the re-receive after the first quarter in which we generate 10 million in revenue from iPop scene I-131.

Speaker Change: The observed safety profile remains consistent with previously reported data.

Speaker Change: Grade 3 or higher, treatment-emerging adverse events occurring in more than 10% of patients in a safety population with an NF65

Speaker Change: Word, thrombocytopenia, 80%, neutropenia, 69.2%, anemia, 44.6%, lymphopenia, 13%, and all infection, 12.3%.

Speaker Change: There were no reported opportunistic or invasive fungal infections observed in the study patients.

Andrei Shustov: In the entirety of the study, there was only one AE-related death reported in the safety set, and it was from infection. Importantly, unlike other WM therapies, Iapophicin demonstrated negligible off-target effects on solid organ systems. Patients did not experience cardiovascular, pulmonary, neurologic, renal, or liver toxicities, which led to treatment discontinuation with other available therapies in a significant proportion of patients. To put Clovowem's safety results into clinical practice perspective, observed cytopenias are consistent with the age-related physiologic loss of marrow function, cumulative amount of prior myosuppressive therapies, and the degree of preexisting inflammatory marrow suppression due Two mid-cycle cytopenia occurrences were transitory and well-managed.

Speaker Change: In the entirety of the study, there was only one AE-related death reported in a safety set, and it was from infection.

Chad Kolean: Assuming our discussions with the FDA was planned, this funding would get a select art to the point where we will be cash flow positive. Turning back to the second quarter, R&D expense was approximately 8.2 million compared to 6.3 million in the second quarter of 2023. The increase is largely driven by the timing of expenditures for our WM pivotal trials for patients final visits and perform the extensive analytic or necessary to complete the NDA submission.

Speaker Change: Importantly,

Speaker Change: Unlike other WM therapies, Iapophicin demonstrated negligible off-target effect on solid organ systems.

Speaker Change: Patients did not experience cardiovascular, pulmonary, neurologic, renal, or liver toxicities, which lead to treatment discontinuation with other available therapies in a significant proportion of patients.

Speaker Change: To put Clovoquam's safety results into clinical practice perspective, observed cytopenias are consistent with the age-related physiologic loss of marrow function

Chad Kolean: We have also continued investing substantial in our product sourcing, manufacturing, and logistics infrastructure by developing multiple sources for each aspect of iPop scene production. GNA transfer the second quarter of 2024 was 6.4 million compared to 2.0 million last year. The Sacramento spend is focused on the establishment of the necessary commercialization capabilities to support product sales upon our expected 2025 NDA approval.

Speaker Change: cumulative amount of prior myosuppressive therapies and the degree of pre-existing inflammatory marrow suppression due to high disease burden in Clover Web patients.

Speaker Change: Two mid-cycle Cytopenia occurrences were transitory and well-managed.

Andrei Shustov: Cytopenias recovered with standard supportive care in all patients within a median two to four weeks of the NADER. Furthermore, despite a high rate and degree of thrombocytopenia, there were no clinically significant or life-threatening bleeding events in the study. Notably, the low rate of serious infections in Clover Web Study patients with known immunosuppressive effects of the underlying malignancy and from prior therapies is encouraging in the context of severely immunocompromised patients. Effective management of cytopenias and prophylaxis of infections attest to the understanding and comfort of hematologic oncologists managing these patients both in an academic setting and in a community.

Speaker Change: The Cytopenias recovered with standard supportive care in all patients within a median 2-4 weeks of the NADER. Further,

Speaker Change: Despite a high rate and degree of thrombocytopenia, there are no clinically significant or life-threatening bleeding events in the study.

Chad Kolean: As Jim stated earlier, we filed an AK with the SEC indicating that we are in the process of restating our historical financial statements for fiscal years 2022 and 2023 in the first quarter of this year. This was precipitated by a reevaluation of the accounting for the warrants issued in October 2022. At the time they were issued, the warrants were classified as equity. This was based on our assessment, which was supported by third-party expert evaluation.

Speaker Change: Notably, the low rate of serious infections

Speaker Change: In Clover Webb study patients with known immunosuppressive effect of underlying malignancy and from prior therapies is encouraging in the context of severely immunocompromised patients.

Chad Kolean: We now believe they should be classified as liabilities and assassinating a revision in our historical reporting. While previously reported earnings will be modified, the restatement does not impact cash or cash burn and the changes to historical earnings will all be non-operating and non-cash. The work required to restate the historical results is in process and must be completed before we can file the second quarter 10Q, which delays the 10Q file.

Speaker Change: Effective management of cytopenias and prophylaxis of infections attest to understanding and comfort of hematologic oncologists managing these patients both in an academic setting and in a community.

Speaker Change: It is also important to point out that with continuous treatment therapies, adverse events such as cardiotoxicity or peripheral neuropathies must be managed over the entire course of treatment or until therapy is discontinued for lack of effectiveness or intolerance with other agents.

Andrei Shustov: It is also important to point out that with continuous treatment therapies, adverse events such as cardiotoxicity or peripheral neuropathies must be managed over the entire course of treatment or until therapy is discontinued for lack of effectiveness or intolerance with other agents. In summary, CLOV-OM was the largest study in relapsed refractory post-BTKI patients to date and the first WM study to evaluate dual refractory and O-class refractory patient populations We believe that achieving an 80% overall response rate and 58.2% major response rate updated after the latest data cutoff with the previously noted durability is nothing short of remarkable, especially with a demonstrated favorable safety profile. Four-dose, truly fixed-duration course of treatment, and prolonged treatment-free interval will provide clinically significant and meaningful benefit for elderly patients with an incurable lifelong malignancy.

Speaker Change: In summary, CLOV-OM was the largest study in relapsed refractory post-BTKI patients to date, and the first WM study to evaluate dual refractory and old-class refractory patient populations.

Chad Kolean: We are performing this work as rapidly as possible, and while we do not have a definite target date for completion, we expect it will take approximately six weeks.

Speaker Change: We believe.

Speaker Change: that achieving an 80% overall response rate and 58.2% major response rate updated after the latest data cutoff with the previously noted durability is nothing short of remarkable.

Andrei Shustov: With that, I will now turn the call over to Andre. Thank you, Chad, and good morning, everyone. Recently, we provided an update on the top-line results from our pivotal global WAM study that is full in roll with all living patients who have completed study treatment remaining in long-term follow-up. There are 65 patients in the safety data set defined as all patients receiving at least one dose of IRP Office in I-131, and there are 55 patients who met the criteria for inclusion in the efficacy available set defined as all patients who have received at least 60 milicury, total administered dose, and have undergone at least one response assessment.

Speaker Change: especially with a demonstrated

Speaker Change: A four-dose, truly fixed-duration course of treatment and prolonged treatment-free interval will provide clinically significant and meaningful benefit for elderly patients with an incurable lifelong malignancy.

Speaker Change: We also anticipate that the data will continue to mature favorably.

Andrei Shustov: We also anticipate that the data will continue to mature favorably. To conclude, we believe, based on the demonstrated global WAMP study results, myopathy has the potential to become a first-in-class and best-in-class radiotherapeutic agent to address the high clinical need for WM patients.

Speaker Change: To conclude, we believe that based on the demonstrated global WAMP study results, Iapophicin has the potential to become first-in-class and best-in-class radiotherapeutic agent to address the high clinical need for WAMP patients.

Andrei Shustov: The response rates and safety data discussed today are as of May 31st, 2024 data cutoff date. As a reminder, Global WAM is a global single-arm Phase 2B study examining IRP Office in I-131 in relapse and refractory patients who have received at least two prior lines of therapy, including those patients who failed or had suboptimal response to BTKI, the only FDA-proof class of treatment for this cancer. Study patients received a total of four doses of IRP Office in I-131 over two cycles without maintenance or retreatment, and were evaluated for response at regular protocol-defined intervals using standard I-W-W-WAM criteria. As gym stated, patients enrolled in Global WAM were the most heavily retreated, and the most refractory WAM patient population ever reported in clinical trials.

Jarrod Longcor: With that, I will turn the call to Jarrod. Thank you, Andrei. As Andrei described, our clinical data from the Clover Wham study continues to be quite impressive and improves with time. We remain actively engaged in the review, quote-unquote, cleaning, and prepping of the Global WAN Pivotal Study data for the near-term NDA submission. As you are aware, the NDA submission process requires relentless attention to detail and is a time-consuming project. For example, for your background, the thousands of patient data points collected over the course of the study must be validated and verified. This is a process called data cleaning, which also includes identifying and correcting any data entry errors.

Speaker Change: With that, I will turn the call to Jarrod.

Jarrod: Thank you, Andrei.

Jarrod: As Andrei described, our clinical data from the Clover Wham study continues to be quite impressive and improves with time.

Jarrod: We remain actively engaged in the review.

Jarrod: "...cleaning and prepping of the Global WAN Pivotal Study data for the near-term NDA submission."

Speaker Change: As you are aware, the NDA submission process requires relentless attention to detail and is a time-consuming project.

Speaker Change: For your background, the thousands of patient data points collected over the course of the study must be validated and verified.

Speaker Change: This is a process called...

Speaker Change: Data Cleaning, which also includes identifying and correcting any data entry errors. Once this process is complete, the database is locked and the final study data sets can be produced for the NDA.

Jarrod Longcor: Once this process is complete, the database is locked, and the final study data sets can be produced for the NDA. This information is required for the completion of the clinical study report and the clinical sections of the NDA submission. We are expediting this process by performing several of these activities in parallel. For example, as a subset of the data is cleaned and finalized, we use this data to complete required sections in both the clinical study report and the NDA rather than waiting for the entirety of the data to be finalized.

Speaker Change: This information is required for the completion of the clinical study report and the clinical sections of the NDA submission.

Speaker Change: We are expediting this process by performing several of these activities in parallel.

Speaker Change: For example, as a subset of the data is cleaned and finalized.

Andrei Shustov: Please allow me to review a few key patient and disease characteristics. The median age was 70 years with oldest enrolled patient aged 88 years. The median number of prior therapies was 4 with a range from 2 to 14. 71 percent of patients were previously treated with BTKI. 91 percent were treated with retuxymap, and 84 percent received prior multiple-agent chemotherapy. Over 90 percent of patients were refractory to at least one class of drugs, with a refractorance to BTKI reported in 67 percent to retuxymap in 60 percent, and to chemotherapy in 56 percent of patients exposed to those treatments.

Speaker Change: We use this data to complete required sections in both the clinical study report and the NDA rather than waiting for the entirety of the data to be finalized.

Jarrod Longcor: This allows us to shorten the traditional timelines of approximately six to eight months of final study results to a submission to around four to six months before that submission time. In addition to these activities, we continue to work closely with the FDA to ensure our submission meets all requirements. Planned remaining FDA interactions prior to the final submission include the determination of the potential need for a confirmatory study, and should the FDA require one, agreement on the design of the confirmatory study, and the pre-NDA meeting with the submission plan for Q4 2024.

Speaker Change: This allows us to shorten the traditional timelines of approximately 6-8 months of final study results to a submission.

Speaker Change: to a submission around four to six months to that submission timeline.

Speaker Change: In addition to these activities, we continue to work closely with the FDA to ensure our submission meets all requirements.

Speaker Change: Planned remaining FDA interactions prior to the final submission include the determination of the potential need for a confirmatory study and Should the FDA require one? Agreement on the design of the confirmatory study and the pre-NDA meeting with submission plan for Q4 2024

Jarrod Longcor: Shifting now to the supply chain, our supply chain and logistics for radiopharmaceuticals have been a challenge for some organizations. There are essentially three main components to the manufacture and supply of radiopharmaceuticals. First, the... Second, the carrier or targeting ligand, and third, the combined finished product. Due to the infrastructure and specialized facilities necessary to produce radioactive isotopes, both the sites of production and supply of these isotopes are limited.

Andrei Shustov: 40 percent of all patients in efficacy set were considered dual-class refractory, including BTKI and retuxymap, and 27 percent were triple-class refractory, including BTKI, retuxymap and chemotherapy. Further, more than half or 55 percent of Global WAM patients in efficacy valuable sets were considered median or high-risk based on IPSS WM score, which is a recognized negative-pregnostic factor for progression-free survival and overall survival in WM patients treated with available therapies. Finally, approximately 30 percent were found to have wild-type mighty ADA gene and known genomic factor-conferring resistance to BTKI therapy.

Speaker Change: Shifting now to the supply chain. Our supply chain and logistics for Radio Pharmaceuticals have been a challenge for some organizations.

Speaker Change: There are essentially three main components to the manufacture and supply of radiopharmaceuticals. First, the isotopes.

Speaker Change: Second, the carrier or targeting ligand, and third, the combined finished product. Due to the infrastructure and specialized facilities necessary to produce radioactive isotopes.

Jarrod Longcor: Whether it's iodine-131 or actinium-225, there are selected sources globally. At Selectar, we have adopted a strategy to contract with suppliers of the isotope directly and to establish these relationships early in our drug development process. As discussed previously, for Iopopacin I-131, which utilizes Iodine-131, we have contracted with and validated three separate suppliers and continue to assess additional suppliers. Our current partners provide redundancy in the isotope supply to allow uninterrupted production of Iopopacin I-131 either weekly or multiple times a week.

Speaker Change: Both the sites of production and supply of these isotopes are limited, whether it's iodine-131 or actinium-225 there are selected sources globally.

Selector: At Selector, we have adopted a strategy to contract with suppliers of the isotope directly and to establish these relationships early in our drug development process.

Selector: As discussed previously, for Iopobizine I-131, which utilizes Iodine-131, we have contracted with and validated three separate suppliers and continue to assess additional suppliers.

Andrei Shustov: Now, let me briefly review key efficacy results. I have published in I-131, demonstrated an impressive and clinically relevant 80% overall response rate and 98.2% clinical benefit rate. This is highly meaningful for this elderly patient population with an incurable malignancy. For these patients, any reduction in tumor burden or even disease stability brings clinical benefit, improves symptoms, and extends progression free survival and time off treatment. The major response rate defined as partial response or better was 56.4%, significantly exceeding the protocol defined primary endpoints statistical hurdle of 20%.

Selector: Our current partners provide redundancy in the isotope supply to allow uninterrupted production of Iopopacin I-131 either weekly or multiple times a week.

Jarrod Longcor: This same model is being employed for our Actinium program. We are partnering with both existing and future suppliers of Actinium, which will provide sufficient supply of Actinium throughout the drug development process and into commercialization. This approach can be employed for a variety of radioisotopes, whether they are alpha, beta, or OG emitting.

Selector: The same model is being employed for our Actinium program. We are partnering with both existing and future suppliers of Actinium, which will provide sufficient supply of Actinium throughout the drug development process and into commercialization.

Selector: This approach can be employed for a variety of radioisotopes, whether they are alpha, beta, or OG emitting.

Jarrod Longcor: The second key component is our targeting ligand, or PLE, which is the basis of our NavVol platform. Similar to the isotope sourcing strategy, we validated and secured sourcing for multiple contractors. Currently, a single targeting ligand batch produces enough of the targeting ligand to allow for greater than a three-year supply of Iopocene I131 at maximum forecasted sales volumes and would support at least one other program with the capacity to increase supply as needed.

Selector: The second key component is our targeting LIGAND or PLE, which is the basis of our NavVol platform.

Selector: Similar to the isotope sourcing strategy,

Selector: We validated and scored sourcing for multiple contractors.

Selector: Currently, a single targeting ligand batch produces enough of the targeting ligand.

Andrei Shustov: We are also excited to report that in line with our previous observation and reported trends in late responses after I have published in therapy, an additional partial response was registered after the latest data cutoff effectively, bringing the MRR to 58.2%. As follow-up of patient continuous, we might expect further improvement in major response rate due to delayed response. Further, the data show the 7.3% complete response or very good partial response rate in a patient population in which CRS have not been previously observed for reported.

Selector: to allow for greater than a three-year supply of Ipofacin I131 at maximum forecasted sales volumes.

Selector: and would support at least one other program with the capacity to increase supply as needed.

Jarrod Longcor: Finally, we're also multisourcing Ipovacin I-131 as the fully finished, ready-to-use product. We currently have two production sites in North America that can supply approximately 200 patient doses per week at current capacity, with the capability to scale to nearly 1,000 weekly doses. In addition to supplying our finished product requirements, our outsourcing model provides additional benefits. For example, we have significantly reduced the capital expenditure and future maintenance costs associated with an internal manufacturing capability.

Selector: Finally, we're also multi-sourcing Ipovucene I-131 as the fully finished, ready-to-use product.

Selector: We currently have two production sites in North America that can supply approximately 200 patient doses per week at current capacity with the capability to scale to nearly 1,000 weekly doses.

Selector: In addition to supplying our finished product requirements, our outsourcing model provides additional benefits.

Selector: One, we have significantly reduced the capital expenditure and future maintenance costs associated with an internal manufacturing capability.

Jarrod Longcor: Second, we have demonstrated the ability to complete the iFocus in i131 technology transfer in a timely and efficient process to multiple sites, which allows for the rapid transition into another organization's manufacturing facility as needed. In addition to addressing potential production constraints unique to radiopharmaceuticals, we have taken a similar approach to addressing potential issues with logistics. We have developed a novel formulation for iopropocene I-131 that provides a 17-day shelf life once produced.

Andrei Shustov: I would treat patients subpopulations. First, among patients with mighty 88 wild-type tumors that are inherently resistant to BTKI therapy, the overall response rate was 81%. And among those previously treated with BTKI, the overall response rate was 72%. In patients with tumors refractory to both BTKI and Rituximap or dual refractory, the overall response rate was 65%. And in those with tumors refractory to BTKI, Rituximap and multiple chemotherapy agents were triple refractory, which are the patients with no available treatment options.

Selector: Second, we have demonstrated the ability to complete the eye-focusing I-131 technology transfer in timely and efficient process to multiple sites, which allows for the rapid transition into another organization's manufacturing facility as needed.

Selector: In addition to addressing potential production constraints unique to radiopharmaceuticals, we have taken a similar approach to addressing potential issues with logistics.

Selector: We have developed a novel formulation for Ipovocine I-131 that provides a 17-day shelf life once produced.

Jarrod Longcor: This unique advantage of iopropocene I-131 provides physicians and patients with greater treatment schedule flexibility and a likely reduction in drug wastage, resulting in a lower total cost of treatment to the health care system. Additionally, like our approach with the sourcing of manufacturing materials, we have partnered with multiple logistics and shipping organizations to ensure global delivery to treatment sites within 48 to 72 hours of production, ensuring a minimum of 14 days and a maximum of 16 days to dose a patient.

Selector: This unique advantage via Focusing Eye 131 provides physicians and patients with greater treatment schedule flexibility and a likely reduction in drug wastage resulting in a lower total cost of treatment to the health care system.

Selector: Additionally, like our approach with sourcing of manufacturing materials, we have partnered with multiple logistics and shipping organizations to ensure global delivery to the treatment sites within 48 to 72 hours of production, ensuring a minimum of 14 days and a maximum of 16 days to dose a patient.

Andrei Shustov: The overall response rate was 54%. Seeing these rate of responses in highly refractory patient population is very impressive. And we believe it positions eye-popping as the standard of care for relapse refractory patients and for development in early lines of therapy.

Jarrod Longcor: As described, we have built a robust and redundant supply chain that allows us to meet the finished product requirements for IFOVCIN I-131 today and into the future. Additionally, this modular outsourced model is being replicated for our other radiotherapeutic programs, like our Actinium program, to ensure clinical research and commercialization supply as needed.

Selector: As described, we have built a robust and redundant supply chain that allows us to meet the finished product requirements for IFOVC and I-131 today and into the future.

Andrei Shustov: The duration of clinical benefit is critical for elbow patients with WM. The treatment-free survival enabled by eye-popping I-131 fixed course of therapy is in sharp contrast with continuous or maintenance therapy approaches currently utilizing with FDA-proof agents and significantly improves patient's quality of life. Durability of responses in Kloewam were set on 41 overall responders and 26 major responders at the data cutoff date on March 7, 2024 with a median follow-up of 8.8 months that did not include for additional overall responses and five additional major responses reported at the latest cutoff date of May 31, 2024.

Selector: Additionally, this modular outsourced model is being replicated for other radiotherapeutic programs, like our Actinium program, to ensure clinical research and commercialization supply as needed.

Shane: I will now turn the call to Shane for the commercial update. Shane? Thank you, Jarrod. Good morning, everyone. I'm excited to share our commercial planning progress regarding the product launch of Iopophycine and Watterson's macroglobulinemia, or WM.

Shane Lea: Thank you, Jarrod. Good morning, everyone. I'm excited to share our commercial planning progress regarding the product launch of Iofocin in Walderson's macroglobulinemia, or WM. We continue to make significant advances in our commercial capabilities and understanding of the WM market dynamics, which, along with the highly scalable nature of the market, will allow our team to capture the WM opportunity with a focused and efficient commercialization model. As previously noted, WM is a rare type of non-Hodgkin's lymphoma with a prevalence of approximately 26,000 patients in the U.S. Of these, about 80% are currently receiving active treatment. The market is highly concentrated, with 80% of the opportunity located in just 15 states.

Shane: We continue to make significant advances in our commercial capabilities and understanding of the WM market dynamics, which, along with the highly scalable nature of the market, will allow our team to capture the WM opportunity with a focused and efficient commercialization model.

Speaker Change: As previously noted, WM is a rare type of non-Hodgkin's lymphoma, with a prevalence of approximately 26,000 patients in the U.S. Of these, about 80% are currently receiving active treatment.

Andrei Shustov: The median duration of response and median progression free survival were not reached with an estimated 72 percent of patients with overall response and 78 percent of patients with major response remaining progression free at 18 months. This is in sharp contrast with our findings using data extracted from community-based oncology providers indicating that among those approximately 10 percent responders in third-plus line of therapy, the duration of response is expected to be around six months.

Speaker Change: The market is highly concentrated with 80% of the opportunity located in just 15 states.

Shane Lea: We plan to pursue a relapsed or refractory indication, which has an estimated population of approximately 11,500 patients. We have also built conservative plans with a base case indication assumption for the third line plus setting, which represents an addressable population of 5,700 patients who could benefit from myopococine therapy. Of these, approximately 4,700 patients are currently receiving Third Line Plus therapy, and approximately 1,000 patients have exhausted all treatment options, leaving them in acute need of new therapy. Additionally, there are approximately 2,200 new 3rd Line Plus patients each year, which means that 2,200 additional patients advance into the 3rd Line Plus treatment setting annually.

Speaker Change: We plan to pursue a relapsal refractory indication which has an estimated population of approximately 11,500 patients.

Speaker Change: We have also built conservative plans with a base case indication assumption for the third line plus setting, which represents an addressable population of 5,700 patients who could benefit from myapophysine therapy.

Speaker Change: Of these, approximately 4,700 patients are currently receiving 3rd Line Plus therapy, and approximately 1,000 patients have exhausted all treatment options.

Andrei Shustov: We anticipate that as our data matures, the durability enabled by both the 80 percent overall response and the 58 percent major response rate will continue to improve and position high-profising as an attractive option in WHO treatment landscape assuming FDA approval. To put Kloewam advocacy results into clinical practice perspective, it is our belief that while MRR is an important endpoint that satisfies the study primary objective threshold and positions I have proficient favorably for regulatory approval and the VGPRCR are important research endpoints that supports I have proficient as disease-modified therapy.

Speaker Change: leaving them in acute need for new therapy.

Speaker Change: Additionally, there are approximately 2,200 new third-line plus patients each year, which means that 2,200 additional patients advance into the third-line plus treatment setting annually.

Shane Lea: Our base case assumption provides a significant Iopophycine market opportunity in terms of the total addressable population and the likelihood of orphan drug prices. Importantly, there is a significant unmet need in the third-line-plus setting, with only approximately 10 percent of third-line-plus patients achieving a major response, and the duration of response for these one-in-ten patients is approximately six months. Moreover, 60% of the drugs utilized in this setting are not FDA approved, which means limited competitor promotional activity and a low share of FOIA. It is also notable that as a result of limited treatment options, approximately 50% of patients are treated with a therapy they received in earlier life. We recently completed additional third-party research evaluating the profile of Ioprophicine in WF. Key findings from this research demonstrated that WFM treaters in college, the urgent need for more effective treatments, and new mechanisms of action.

Speaker Change: Our base case assumption provides a significant iapophysine market opportunity in terms of the total addressable population and the likelihood of orphan drug pricing.

Speaker Change: Importantly, there is a significant unmet need in the third line plus setting with only approximately 10% of third line plus patients achieving a major response and the duration of response for these one in ten patients is approximately six months.

Andrei Shustov: It is the overall response rate and clinical benefit rate combined with impressive durability and time of treatment that will drive treatment decisions in favor of I have proficient in the management of this challenging patient population. I have proficient I-131 was well-tolerated in this vulnerable elderly patient population possessing multiple age-related formabilities with their bone marrow compromised by cancer and multiple prior toxic theorems. The observed safety profile remains consistent with previously reported data.

Speaker Change: Moreover, 60% of the drugs utilized in this setting are non-FDA approved, which means limited competitor promotional activity and a low share of voice.

Speaker Change: It is also notable that as a result of limited treatment options, approximately 50% of patients are treated with a therapy they received earlier line.

Speaker Change: We recently completed additional third-party research evaluating the profile of iapophicine in WM. The key findings from this research demonstrated that WM treaters in college, the urgent need for more effective treatments, new mechanisms of action.

Shane Lea: The WM Treaters also emphasize the importance of achieving durable responses and maintaining a high quality of life for patients with the primary treatment goal of reducing IgM levels. We also observed an interesting finding that there was a lack of consistency in treatment goals amongst hematologists because of the heterogeneity of disease. In other words, most therapies are limited in clinical benefit based on patient characteristics. Therefore, this creates a lack of consistency with treatment approach and outcome based on the limitations of the existing therapy.

Andrei Shustov: Grade 3 or higher treatment emergent adverse events occurring in more than 10 percent of patients in the safety population with an N of 65 were thermbocytopenia 80 percent neutropenia 69.2 percent anemia 44.6 percent lymphopenia 13 percent and all infection 12.3 percent there are no reported opportunistic or invasive fungal infections observed in the study patients in the entirety of the study there was only one a year related death reported in a safety set and it was from infection. Importantly unlike other WM therapies I have proficient demonstrated negligible off target effect on solid organ systems.

Speaker Change: The WM Treaters also emphasize the importance of achieving durable responses and maintaining a high quality of life for patients with the primary treatment goal of reducing IgM levels.

Speaker Change: We also observed an interesting finding that there was a lack of consistency in treatment goals amongst rheumatologists because of the heterogeneity of disease. In other words, most therapies are limited in clinical benefit based on patient characteristics.

Speaker Change: Therefore, this created lack of consistency with treatment approach and outcome based on the limitations of existing therapies.

Shane Lea: The same hematologists who participated also reviewed the Iopofacin product profile and provided a highly positive rating, acknowledging that Iopofacin addresses key treatment goals and existing unmet needs while highlighting the fixed course of therapy. They were very encouraged by Iopococine's results in such a difficult patient population, noting its potential to treat the broad WM patient population, which contrasts with existing therapies. Iococcine's efficacy and unique mechanism of action were highlighted as key differentiators for its use in WM.

Speaker Change: the same hematologist participants.

Speaker Change: also reviewed the Iopofacin product profile and provided a highly positive rating acknowledging that Iopofacin addresses key treatment goals and existing unmet needs while highlighting the fixed course of therapy.

Andrei Shustov: Patients did not experience cardiovascular pulmonary neurologic renal olivertexicity which lead to treatment discontinuation with all the available therapies in a significant proportion of patients. To put phlogogram safety results into clinical practice perspective, observed cytopenias are consistent with the age-related physiologic loss of marrow function, cumulative amount of prior myosuppressive therapies, and a degree of pre-existing inflammatory marrow suppression due to high disease burden in phlogogram patients. Two mid-cycle cytopenia currencies were transitory and well-managed.

Speaker Change: Hematologists were very encouraged by Iopopracine's results in such a difficult patient population, noting its potential to treat the broad WM patient population, which contrasts with existing therapies.

Speaker Change: Biofocusine's efficacy and unique mechanism of action were highlighted as key differentiators for its use in WM.

Shane Lea: We were encouraged by this research, supporting our belief that iapophicine will be highly differentiated to address the clear unmet need in WM, providing durable, meaningful responses regardless of patient characteristics, with a fixed course of therapy, thereby simplifying the treatment process for providers and patients. In conclusion, our commercialization efforts are advancing steadily to support the potential U.S. launch of iapofecine for WM. The research findings underscore a significant unmet need and the potential impact of ipofacine for the treatment of WM.

Speaker Change: We were encouraged by this research supporting our belief that iophophicine will be highly differentiated to address the clear unmet need in WM, providing durable, meaningful responses regardless of patient characteristics.

Speaker Change: with a fixed course of therapy, thereby simplifying the treatment process for providers and patients.

Andrei Shustov: The cytopenias recovered with standard supportive care in all patients within a median two to four weeks of the nadir. Further, despite a high rate and degree of thrombocytopenia, there are no clinic with significant or life-threatening bleeding events in the study. Notably, the low rate of serious infections in chloro-wemps study patients with known immunosuppressive effect of underlying malignancy and from prior therapies is encouraging in the context of severely immunocompromised patients. Effective management of cytopenias and prophylaxis of infectious, attest to understanding and comfort of hematologic oncologists managing these patients both in academic setting and in a community.

Speaker Change: In conclusion, our commercialization efforts are advancing steadily to support the potential U.S. launch of Iopophycine and WM.

Speaker Change: The research findings underscore a significant unmet need and the potential impact of ipophazine for the treatment of WM.

Shane Lea: We are confident that Iopofacin's unique profile and demonstrated efficacy will address the critical needs of WM patients and provide a much-needed new treatment option with potential FDA approval. I will now turn the call back over to Jim Caruso for closing remarks. Thank you, Shane. It certainly remains an exciting time for us at Selectar. With a potential approval for Iopophycin I-131 on the horizon, coupled with our unique delivery platform providing differentiated radioisotope offerings, we are confident in our market position and excited about our future. We look forward to meaningful milestones in the second half of this year, positioning us for further and Real Growth. With that, I would now like to open the call for Q&A. Operator.

Jim Caruso: We are confident that Iopofazine's unique profile and demonstrated efficacy will address the critical needs of WM patients and provide a much needed new treatment option with a potential FDA approval. I will now turn the call back over to Jim Caruso for closing remarks.

Speaker Change: Thank you, Shane.

Jim Caruso: It certainly remains an exciting time for us at SelectR.

Jim Caruso: With a potential approval for Iopopacin I-131 on the horizon, coupled with our unique delivery platform providing differentiated radioisotope offerings, we are confident in our market position and excited about our future.

Andrei Shustov: It is also important to point out that with continuous treatment therapies, adverse events such as cardiac toxicity of peripheral neuropathy must be managed over the entire course of treatment or until therapy is discontinued for lack of effectiveness or intolerance with other agents.

Speaker Change: We look forward to our meaningful milestones in the second half of this year, positioning us for further advancement.

Andrei Shustov: In summary, chlovo-wemps was the largest study in relapse refractory post-BTKI patients to date, and the first WM study to evaluate dual refractory and old-glass refractory patient populations. We believe that achieving an 80% overall response rate and 58.2% major response rates updated after the latest data cutoff with the previously noted durability is nothing short of remarkable, especially with a demonstrated favorable safety profile. The four-dose, truly fixed duration course of treatment and prolonged treatment for inner role will provide clinically significant and meaningful benefit for elbow patients with an incurable life-long elegance.

Speaker Change: and Real Growth as a company.

Speaker Change: With that, I would now like to open the call for Q&A.

James Caruso: Thank you. Ladies and gentlemen, we will now begin the question and answer session. Should you have a question, please press star followed by the number one on your touchtone phone. You will hear a prompt that your hand has been raised. Should you wish to decline from the polling process, please press star followed by the number 2. If you are using a speakerphone, please leave the handset before pressing any key.

Speaker Change: Operator.

Speaker Change: Thank you. Ladies and gentlemen, we will now begin the question and answer session. Should you have a question, please press star followed by the number one on your touchtone phone.

Speaker Change: You will hear a prompt that your hand has been raised. Should you wish to decline from the polling process, please press star followed by the number 2. If you are using a speakerphone, please leave the handset before pressing any keys. One moment please for your first question.

Operator: One moment, please, for your first question. And your first question comes from Jonathan Aschoff of Afra. Please go ahead. Your line is open.

Speaker Change: And your first question comes from Jonathan Ashkoff, Afra. Please go ahead, your line is open.

Jonathan Aschoff: Thank you. Good morning, guys. I think I might have missed a couple of numbers you were throwing out there. Do you have a new major response rate of 58 point something? That is correct, Jonathan. With the latest data cut, it's now 58.2%. And I think Andrei can talk about one of the reasons why, you know, we see consistent improvement over time with Ipofacin in these patients. And that's based on what?

Jonathan Ashkoff: Thank you. Good morning guys. I think I might have missed a couple of numbers you were throwing out there. Do you have a new major response rate of 58 point something?

Andrei Shustov: We also anticipate that the data will continue to mature favorable. To conclude, we believe that based on the demonstrated chlovo-wemps study results, biopopasin has the potential to become first in class and best in class radiotherapeutic agents to address the high clinical need for double M patients.

Jonathan Ashkoff: That is correct, Jonathan. With the latest data cut, it's now 58.2%. And I think Andrei can talk to, you know, one of the reasons why, you know, we see consistent improvement over time with iapoficine for these patients. And that's based on what? Thank you, Jonathan.

Jarrod Longcor: With that, I will turn to Paul to Jared. Thank you, Andre. As Andre described, our clinical data from chlovo-wemps study continues to be quite impressive and improves with time. Remain actively engaged in the review, quote-unquote cleaning and prepping of the chlovo-wemps pivotal study data for the near-term NDA submission. As you are aware, the NDA submission process requires relentless attention to detail and is a time-consuming project. For your background, the thousands of patient data points collected over the course of the study must be validated and verified.

Jonathan Ashkoff: Four.

Andrei: You can say that. It's based on what ends. Yeah, the patient ends.

James Caruso: Thank you, Jonathan. You can say that it's based on what the patient and we have Jonathan, good morning, Andrei here. So we have 55 patients in the efficacy-available set. And as Jim pointed out, after the most recent data cutoff, we just registered another late response, effectively bringing the MRR rate to 58.2%.

Andrei: So we have, Jonathan, good morning, Andrei here. So we have 55 patients in the efficacy-available set.

Andrei: And as Jim pointed out, after the most recent data cutoff, we just registered another late response, effectively bringing the MRR rate to 58.2%. We also expect...

Andrei Shustov: We also expect that we might see additional major responses based on our prior observation that we demonstrated or reported in January that responses can occur as late as six months after receiving therapy. So, we would not be surprised, and we actually anticipate that we might have additional major responses as follow-up continues. Okay, that's very helpful. Chad, can you help us out a little closer on even if it's just the bottom result for the quarter, meaning the net income?

Speaker Change: that we might see additional major responses based on our prior observation that we demonstrated or reported in January that responses can occur as late as six months after receiving therapy.

Jarrod Longcor: This is a process called data cleaning, which also includes identifying and correcting any data entry errors. Once this process is complete, the data pace is locked, and the final study data sets can be produced for the NDA. This information is required for the completion of the clinical study report and the clinical sections of the NDA submission. We are expediting this process by performing several of these activities in parallel. For example, as a subset of the data is cleaned and finalized, we use this data to complete required sections in both the clinical study report and the NDA rather than waiting for the entirety of the data to be finalized.

Speaker Change: So, we would not be surprised and we actually anticipate that we might have additional major responses as follow-up continues.

Chad Kolean: And can you help us out on a share count and whether that's a time point or not? So I can't provide a net income at this point, Jonathan, because the restatement has to be brought all the way forward. The evaluation needs to be done on a quarter-by-quarter basis too, to do that. That's why we didn't provide it in the comments, unfortunately. We simply need to work through that before we can, before we can essentially publish that information. So my apologies there. We did obviously provide operating expenses, but the non-operating components need to be further. And how about the share count?

Speaker Change: Thank you.

Speaker Change: Okay, that's very helpful. Chad, can you help us out a little closer on, even if it's just the bottom result for the quarter, meaning the net income, and can you help us out on a share count and whether that's a time point or a weighted average?

Chad Kolean: So I can't provide a net income at this point, Jonathan, because the restatement has to be brought all the way forward. The evaluation needs to be done on a quarter-by-quarter basis, too.

Jarrod Longcor: This allows us to shorten the traditional timelines of approximately six to eight months final study results to a submission, to a submission around to four to six months to that submission timeline. In addition to these activities, we continue to work closely with the FDA to ensure our submission meets all requirements.

Chad Kolean: to do that. That's why we didn't provide it in the comments unfortunately. We simply need to work through that before we can

Chad Kolean: before we can essentially publish that information. So my apologies there. We did obviously provide operating expenses, but the non-operating components need to be perfectly sanitized.

Jarrod Longcor: Planned remaining FDA interactions prior to the final submission include the determination of the potential need for a confirmatory study and should the FDA require one agreement on the design of the confirmatory study and the pre-NDA meeting with submission plan for Q4 2024.

Jonathan Ashkoff: And how about a share count?

Chad Kolean: So, on the share front, I will, I think the expectation is we're going to get an 8k published on that because I want to essentially publish the entire tab table. And so that is forthcoming. You should have that in the very near future.

Jonathan Ashkoff: So, on the share front,

Jonathan Ashkoff: Thank you.

Jarrod Longcor: Shifting now to the supply chain, our supply chain and logistics for radio pharmaceuticals have been a challenge for some organizations. There are essentially three main components to the manufacturer and supply of radio pharmaceuticals. First, the isotope. Second, the carrier or targeting ligand. And third, the combined finished product. Due to the infrastructure and specialized facilities necessary to produce radioactive isotopes, both the sites of production and supply of these isotopes are limited. Whether it's iodine 131 or actinium 225, there are selective sources globally.

Jonathan Ashkoff: I will, I think the expectation is we're going to get an 8K published on that because I want to essentially publish the entire cap table and so that is forthcoming. You should have that in the very near future.

Chad Kolean: Okay, that's helpful. This is also something I may have missed. But when will your HGG data come out, your next data set for that? And how's about starting the timing for phase one for the alpha emitter actinia?

Speaker Change: Okay, that's helpful. This is also something I may have missed, but when will your HGG data come out, your next data set for that, and how's about starting the timing for phase one for the alpha emitter actinium?

James Caruso: Sure, I'll have Andrei talk to the Pediatric High-Grade Glioma Study, and then Jarrod can address our work with our Actinium-based program. Thanks again, Jonathan. We started enrollment in the AGG study at the very beginning of this year, with patients already enrolled in the study and a few patients being screened as we speak. We anticipate that we'll provide initial results from that study by the end of the year. And I'm starting phase one. Yeah, great question, Jonathan.

Speaker Change: Sure, I'll have Andrei talk to the Pediatric High-Grade Glioma Study and then Jarrod can address our work with our Akinium-based program.

Jarrod Longcor: At SELECTAR, we have adopted a strategy to contract with suppliers of the isotope directly and to establish these relationships early in our drug development process. As discussed previously, for IOPOVC9131, which utilizes iodine 131, we have contracted with and validated three separate suppliers and continue to assess additional suppliers. Our current partners provide redundancy in the isotope supply to allow uninterrupted production of IOPOVC9131 either weekly or multiple times a week. The same model is being employed for our actinium program.

Speaker Change: Thanks again, Jonathan. We started enrollment in the HGG study at the very beginning of this year.

Speaker Change: with patients already enrolled in the study and a few patients being screened as we speak. We anticipate that we'll provide initial look, initial results from that study by the end of the year.

Speaker Change: Okay.

Jarrod Longcor: So, real fast, what I'd say is, you know, we sit at a unique advantage in that our phospholipid ether delivery targeting modality is validated, based on the iophobosine data as a validated targeting ligand. And we have a unique advantage in that that allows us to accelerate our timelines for clinical trials and completion of IND enabling studies. I think, as we mentioned before, we expect to complete the IND enabling studies here in the fourth quarter of this year and either late this year or early next year initiate that phase one study with the actinium protein.

Speaker Change: And that's how we're starting phase one.

Jarrod Longcor: We are partnering with both existing and future suppliers of actinium, which will provide sufficient supply of actinium throughout the drug development process and inter-commercialization. This approach can be employed for a variety of radioisotopes, whether they are alpha, beta, or OZ emitted. The second key component is our targeting ligand or PLE, which is the basis of our arable platform. Similar to the isotope sourcing strategy, we validated and explored sourcing from multiple contractors.

Speaker Change: Yeah, no great great question that Jonathan so real fast What I'd say is you know we sit in a unique advantage in that our phospholipid ether delivery targeting modi is a validated

Speaker Change: based on the IAPOVACINE data as a validated targeting ligand.

Speaker Change: And we have a unique advantage in that that allows us to accelerate our timelines into clinical trials and

Speaker Change: Completion of IND Enabling Studies.

Speaker Change: I think as we mentioned before, we expect to complete the IND enabling studies here in the fourth quarter of this year and either late this year or early next year, initiate that phase one study with the Actinian broker.

Jarrod Longcor: Currently, a single targeting ligand back produces enough of the targeting ligand to allow for greater than a three-year supply of IOPOVC9131 at maximum forecasted sales volumes and would support at least one other program with the capacity to increase supply as needed. Finally, we are also multi-sourcing IOPOVC9131 as the finally finished ready-to-use product. We currently have two production sites in North America that can supply approximately 200 patient doses per week at current capacity, with the capability to scale to nearly 1,000 weekly doses.

Jarrod Longcor: And Jarrod, we haven't talked about it very much, but could you share a little bit about the OG program? Yeah, absolutely. So, obviously, as Jim just alluded to, Jonathan, we've got, you know, as we've talked about, validated with a number of different isotopes or different emitting isotopes. And as Jim just said, we also have the advantage of being able to use OG emitting isotopes quite readily.

Jarrod: And Jarrod, we haven't talked about it very much, but could you share a little bit about the OG program? Yeah, absolutely. So, obviously, as Jim just alluded to,

Speaker Change: Jonathan, you know, we've gone, you know, as we've talked about, we've validated with a number of different

Jarrod: isotopes or different emitting isotopes and as Jim just said we also have the advantage of being able to use OG emitting isotopes quite readily and we do have a program that has been in the background for a while that we're moving forward with that we would expect that we could quickly initiate a phase one study in that arena as well shortly on the heels of the Actinium.

Jarrod Longcor: We do have a program that has been in the background for a while that we're moving forward with, and we would expect that we could quickly initiate a phase one study in that arena as well, shortly on the heels of the actinium, pending capital. Okay, that answers my questions. Thank you, guys. Thank you, Jonathan. And your next question comes from Jeff Chung of Oppenheimer. Please go ahead. Your line is open. Hi guys, and thanks for taking the question. A couple from me.

Jarrod Longcor: In addition to supplying outfinished product requirements, our outsourcing model provides additional benefits. One, we have significantly reduced the cap-hooks-benitur and future maintenance costs associated with an internal manufacturing capability. Second, we have demonstrated the ability to complete the eye-focusing I-131 technology transfer in timely and efficient process to multiple sites which allows for the rapid transition into another's organization's manufacturing facility as needed.

Speaker Change: spending capital.

Speaker Change: Okay, that answers my questions. Thank you guys.

Speaker Change: All right. Thank you, Jonathan.

Speaker Change: And your next question comes from Jeff Chung of Oppenheimer. Please go ahead, your line is open.

Jeff Chung: Andrei, you gave a really long and really detailed update on the data. And obviously, the key thing there was the increase in the MRRR. Were there any other changes that we might have missed from the prior data set that was described in July? Thank you, Jeff. I don't think you missed anything.

Jeff Chung: Hi, guys, and thanks for taking the question. A couple from me. Andrei, you gave a really long and really detailed update on the data. And, obviously,

Jarrod Longcor: In addition to addressing potential production constraints unique to radio pharmaceuticals, we have taken a similar approach to addressing potential issues with logistics. We have developed a novel formulation for eye-focusing I-131 that provides a 17-day shelf life once produced. This unique advantage for eye-focusing I-131 provides physicians and patients with greater treatment schedule flexibility. And I like the reduction in drug waste resulting in a lower total cost of treatment to the healthcare system.

Jeff Chung: key up there was the increase in the MRRR. Were there any other changes that I might have missed from the prior data set that was described in July?

Andrei Shustov: This is the single most impactful update, even though it's just one additional response. It brings us closer to our previously reported number within a margin of error. So the current MRR effectively is 58.2%, and we expect that in the next few months additional responses might convert from minor to major responses as we modelled at the beginning of the year. But where we sit now is 58.2%, and that's the most impactful update from a month ago.

Speaker Change: Thank you, Jeff. I don't think you missed anything. This is the single most impactful update. Even though it's just one additional response, it brings us closer to our previously reported number within margin of error. So the current MRR effectively is 58.2%.

Jarrod Longcor: Additionally, like our approach with sourcing of manufacturing materials, we have partnered with multiple logistics and shipping organizations to ensure global delivery to the treatment sites within 48 to 72 hours of production, ensuring a minimum of 14 days and a maximum of 16 days to dose of patient. And as described, we have built a robust and redundant supply chain that allows us to meet the finished product requirements for eye-focusing I-131 today and into the future. Additionally, this modular outsourced model is being replicated for other radio therapeutic programs like our Actinian program to ensure clinical research and commercialization supply as needed.

Speaker Change: And we expect that we might have, in the next few months, additional responses converting from minor to major responses as we model at the beginning of the year.

Speaker Change: But where we sit now is 58.2% and that's the most impactful update from a month ago.

Jarrod Longcor: Great, thank you. In terms of the NDA filing, one of the major reasons folks have been getting, you know, refusals to file or rejections has been on the CMC side. So, you talked a lot about the importance of the supply chain and how you built redundancy in your supply chain, but can you speak to the level of confidence in the NDA filing in the CMC section or perhaps what you've done in terms of quality audits and preparations for FDA inspections? Yeah, absolutely. So that's a great question, Jeff. And there's a lot to unpack in that.

Speaker Change: Great, thank you. In terms of the NDA filing,

Shane Lea: I will now turn the call to Shane for the commercial updates. Shane. Thank you, Jared.

Speaker Change: One of the major reasons folks have been getting, you know, refusal to files or rejections

Shane Lea: Good morning, everyone. I'm excited to share our commercial planning progress, reporting the product launch of eye-focusing, water streams of macro-globulinemia, or WM. We continue to make significant advances in our commercial capabilities and understanding of the WM market dynamics, which along with the highly scalable nature of the market, will allow our team to capture the WM opportunity with a focused and efficient commercialization model. As previously noted, WM is a rare type of non-Hashton's lymphoma with a prevalence of approximately 26,000 patients in the U.S. Of these, about 80 percent are currently receiving active treatment.

Speaker Change: have been on the CMC side.

Speaker Change: So you talked a lot about the importance of supply chain and how you built redundancy in your supply chain.

Speaker Change: But can you speak to the level of confidence in the NDA filing, in the CMC section, perhaps what you've done in terms of quality audits and preparations for FDA inspections?

Speaker Change: Yeah, absolutely. So, that's a great question, Jeff. And there's a lot to unpack in that, so I'll try to unpack as much as I can in a little bit of time here.

Jarrod Longcor: So I'll try to unpack as much as I can in a little bit of time here. But as far as our confidence is concerned, we are highly confident for a number of reasons, not least of which, you know, we've done this for a while now, particularly one of those facilities we've been producing Iopopracine at, and we have not missed a single batch in over three years. As I mentioned, we've replicated that process, and the second facility has produced multiple batches now, a number of batches at that facility without any hitches as well.

Shane Lea: The market is highly concentrated with 80 percent of the opportunity located in just 15 states. We plan to pursue a relapse or refractory indication, which has an estimated population of approximately 11,500 patients. We have also built conservative plans with a base-case indication assumption for the third-line plus setting, which represents an addressable population of 5,700 patients who could benefit from my opposing therapy. Of these, approximately 4,700 patients are currently receiving third-line plus therapy, and approximately 1,000 patients have exhausted all treatment options, leaving them an acute need for new therapy.

Speaker Change: So as it comes to our confidence, we are highly confident for a number of reasons, not least of which, you know, we've done

Speaker Change: We've been producing Iopopracine at...

Speaker Change: These facilities for a while now, particularly one of those facilities we've been producing and have not missed a single batch in over three years. As I...

Speaker Change: exemplified. We've replicated that process and the second facility have produced multiple batches now, a number of batches at that facility without any hitches as well. So we're very confident in the robustness of the ability to do the tech transfer and of both manufacturing facilities to

Jarrod Longcor: So we're very confident in the robustness of the ability to do the tech transfer and of both manufacturing facilities to actually produce the material as defined inside the criteria as necessary for release. In addition to that, you know, again, we've done that from the beginning to the end of things. And, you know, like anything, we use a design sort of approach with our manufacturing that allows us to get control by design, or quality by design, sort of approach.

Shane Lea: Additionally, there are approximately 2,600 new third-line plus patients each year, which means that 2,200 additional patients advance into the third-line plus treatment setting annually. Our base-case assumption provides a significant eye-oprophicine market opportunity in terms of the total addressable population in the likelihood of orphan drug prices. Icing. Importantly, there is a significant unmet need in the third line plus setting, with only approximately 10% of third line plus patients achieving a major response, and the duration of response for these 1 in 10 patients is approximately 6 months.

Speaker Change: to actually produce the material as defined inside the criteria as necessary for release. In addition to that, you know, again, we've done that from the beginning to the end of sort of things. And, you know, like anything, we use a...

Speaker Change: you know, design.

Speaker Change: sort of approach with our manufacturing that allows us to get control by design sort of or quality by design sort of approach. So we're always looking to optimize and enhance that a little by little.

Jarrod Longcor: So we're always looking to optimize and enhance that, little by little. So that's part of it. The other piece that I think we've done is, you know, when we started this process, we actually, and I'm going to get into a little bit too much detail probably, but we took this outside of our hands and we actually had an outside group come in and do a gap analysis on our entire manufacturing process from beginning to end to identify any potential gaps and any historical areas that we would need to backfill for questions we might want to answer to make sure our And we did just that.

Speaker Change: So, that's part of it. The other piece that I think we've done is, you know, when we started this process, we actually, and I'm going to get in a little bit too much detail probably, but we took this outside of our hands and we actually had an outside group come in.

Shane Lea: Moreover, 60% of the drugs utilized in this setting are not FDA approved, which means limited competitor promotional activity and a low share of voice. It is also notable that as a result of limited treatment options, approximately 50% of patients are treated with a therapy they received earlier line. We recently completed additional third-party research evaluating the profile of Iopofacine and WM, the key findings from this research demonstrated that WM Treaters at College, the urgent need for more effective treatments, new mechanisms of action.

Speaker Change: And do a gap analysis on our entire manufacturing process from beginning to end to identify any potential gaps and any historical.

Speaker Change: areas that we would need the backfill for questions we might want to answer to make sure our-

Jarrod Longcor: One of those folks was actually a gentleman who used to work at the FDA and had actually established a lot of their radiopharmaceutical manufacturing criteria. So we were taking a very robust look at that and we've gone through that and we continue to sort of reassess. Now, as you enunciated, the last piece is, you know, the audits, as I'll call them, whether that be pre-FDA audits or regular audits. We do our own regular audits both by our team and by external teams every couple years with all of the sites.

Speaker Change: Our submission was as robust as possible and we did that.

Speaker Change: One of those folks was actually a gentleman who used to work at the FDA and had actually established a lot of their radiopharmaceutical manufacturing criteria. So we were taking a very robust look at that and we've gone through that and we continue to sort of reassess it.

Shane Lea: The WM Treaters also emphasized the importance of achieving durable responses and maintaining a high quality of life for patients with the primary treatment goal of reducing IgM levels. We also observed an interesting finding that there was a lack of consistency in treatment goals amongst the metallurgists because of the heterogeneity of disease. In other words, most therapies are limited in clinical benefit based on patient characteristics. Therefore, this created lack of consistency with treatment approach and outcome based on the limitations of existing therapies.

Speaker Change: Now, as you enunciated, the last piece is, you know, the audits, as I'll call them, whether that be pre-FDA audits or regular audits. We do our own regular audits both by our team and by external teams.

Jarrod Longcor: We've done that, and right now, we've done it with everybody leading up to the FDA submission. To your point, we are with every one of our manufacturers right now. We do have on the books the plan to do pre-FDA, pre-NDA evaluations so that when they do get audited, we will have already gone through them once just to make sure and, you know, tighten the screws so that everything is above board and appropriate, so to speak.

Speaker Change: every couple of years with all of the sites. So we've done that. And we and right now we've done it with everybody leading into the FDA submission.

Speaker Change: To your point, we are, with every one of our manufacturers right now, we do have on the books the plan to do pre-FDA, pre-NDA evaluations so that when they do get audited, we will have already gone through there again just to make sure and

Shane Lea: The same from metallurgist participants also reviewed the Iopofacine product profile and provided a highly positive rating acknowledging that Iopofacine addresses key treatment goals and existing unmet needs while highlighting the fixed course of therapy. The metallurgists were very encouraged by Iopofacine's results in such a difficult patient population, noting its potential to treat the broad WM patient population, which contrasts with existing therapies. Iopofacine's efficacy and unique mechanism of action were highlighted as key differentiators for its use in WM.

Speaker Change: You know tighten the screws so that everything is above board and appropriate so to speak

Jarrod Longcor: Perfect. Thank you very much for that, Jarrod. And then one very quick clarification. For the actinium-based program in solid tumors, the carrier there is the same as iopocasin, correct? Or is there a modification? There is a modification, but what I would say is that it's about 90-ish percent, 95%, depending on what chemist you ask. The same.

Speaker Change: Perfect. Thank you very much for that, Jarrod. And then one very quick clarification. For the actinium-based program in solid tumors, the carrier there is the same as iopocasin, correct? Or is it a modification?

Shane Lea: We were encouraged by this research supporting our belief that Iopofacine will be highly differentiated to address the clear unmet need in WM providing durable meaningful responses regardless of patient characteristics with a fixed course of therapy, thereby simplifying the treatment process providers and patients.

Speaker Change: There is a modification, but what I would say is that it's about 90-ish percent, 95 percent, depending on what chemist you ask, the same. There are slight tweaks.

Jeff Chung: There are slight tweaks. So in essence, the targeting agent is the, Exactly. Got it. Great. Thanks, guys. All right. Thank you, Jeff.

Speaker Change: So, in essence, the targeting agent is the same.

Speaker Change: Exactly. Got it. Got it. Great. Thanks guys.

Shane Lea: In conclusion, our commercialization efforts are advancing steadily to support the potential U.S, launch of Iopofacine and WM. The research findings underscore significant unmet need and the potential impact of Iopofacine for the treatment of WM. We are confident that Iopofacine unique profile and demonstrated efficacy will address the critical needs of WM patients providing much needed new treatment option with a potential FDA approval.

James Caruso: We appreciate your questions and, obviously, your continued interest and support of the company. Thank you, Thank you. And your next question comes from Ahu Demir of Lirenberg, Kalman. Please go ahead. Your line is open. Good morning. This is Chhong for Ahu Demir.

Speaker Change: All right, thank you, Jeff. We appreciate your questions and obviously, you know, your continued interest and support of the company. Thank you.

Speaker Change: Thank you, and your next question comes from Ahu Demir of Lirenburg, Kalman. Please go ahead, your line is open.

Ahu Demir: Thank you for taking our questions. We also have a question regarding the NDA application. So for the application, what population are you targeting?

Speaker Change: Good morning, this is Chong for Ahu Demir. Thank you for taking our questions. We also have a question regarding the NDA applications.

James Caruso: I will now turn the call back over to Jim Caruso for closing remarks. Thank you, Shane. It certainly remains an exciting time for us at SelectR with a potential approval for Iopofacine I-131 on the horizon coupled with our unique delivery platform providing differentiated radioisotope offerings. We are confident in our market position and excited about our future. We look forward to our meaningful milestones in the second half of this year, positioning us for further advancements and real world as a company. Because that, I would now like to open the call for you and that. Operator. Thank you.

Chong: So, for the application, what population are you targeting? Will it be three-line clients, patients treated with the BTK inhibitor before, or it will be double or triple refractory patients?

James Caruso: Will it be three-line clients, patients treated with a BTK inhibitor before, or will it be double or triple refractory patients? And are there any additional analyses that the company plans to do prior to the submission? Thank you. Okay, prior to handing it over to Jarrod and Andrei for their perspective and opinions here, you know, as we originally designed the study, it was for a third-line grader, originally post-BTKI. Based on the patient population and role that supported that, it's essentially a relapsed and refractory patient population.

Speaker Change: And are there any additional analysis that the company plans to do prior to the submission? Thank you.

Speaker Change: Okay, I think prior to handing it over to Jarrod and Andrei for their perspective and optics here.

Jarrod: You know, as we originally designed the study, it was for a third line or greater, originally post-BTKI. Based on the patient population and role that supported that, it's essentially a relapsed refractory patient population. And so...

Unknown Executive: Ladies and gentlemen, we will go between the question and answer session. Should you have a question, please press star, followed by the number one on your touchstone phone. You will hear a prompt that your hand has been raised. Should you wish a decline from the polling process, please press star, followed by the number two. If you are using a speaker phone, please leave the handset before pressing any keys. One moment please for your first question.

James Caruso: And so, you know, it is our belief that we have an opportunity, as we continue to engage with the FDA, that our data package would be supportive of a relapsed refractory indication or essentially second-line and beyond. And so I can have Jarrod and or Andrei provide both the regulatory and some of our clinical thinking around that. Yeah, I think from a regulatory perspective, you know, if you look at the patient population, as Jim said, and as Andrei defined or described to you when you look at patient characteristics, you can clearly see that this is a highly relapsed refractory patient population, whether you want to cut it from post-BTKI, which essentially, you know, BTKIs are predominantly being used in the first line these days kind of element, to whether you just want to say, let's just look at the refractory.

Speaker Change: It is our belief that we have an opportunity as we continue to engage.

Speaker Change: with the FDA that our data package would be supportive of a relapsed refractory indication or essentially second line and beyond. And so I can have Jarrod and or Andrei provide both the regulatory and some of our clinical thinking around that.

Jonathan Aschoff: And your first question comes from Jonathan Aschoff. Operator, please go ahead. Your line is open. Thank you. Good morning, guys. I think I might have missed a couple of numbers you are throwing out there. Do you have a new major response rate of 58 points, something? That is correct, Jonathan. With the latest data cut, it's now 58.2%. And I think Andre can talk to, you know, one of the reasons why, you know, we see consistent improvement over time with our focusing for these patients. And that's based on what? Thank you, Jonathan. You can say that. It's based on what? The patient. And so we have Jonathan.

Jarrod: Yeah, I think from a regulatory perspective, you know, if you look at the patient population as Jim said and as Andrei defined or described to you in the when you look at the patient characteristics

Jarrod: You can clearly see that this is a highly relapsed refractory patient population, whether you want to cut it from post-BTKI, which essentially is, you know, BTKIs are predominantly being used for spine these days, kind of.

Speaker Change: to whether you just want to say, let's just look at the refractory. I think the key element there is, as Andrei stated...

James Caruso: I think the key element here is, as Andrei stated, the data shows that irrespective of the patient population, the drug works consistently and robustly in all of these patients. And because of that, when the agency or any agency evaluates the drug based on that, and they start to do sub-analyses, what you see is there's really no change in the patient population or the response rates.

Speaker Change: The data shows that irrespective of the patient population, the drug works consistently and robustly in all of these patients. And because of that, when the agency or any agency evaluates the drug based off of a

Andrei Shustov: Good morning, Andre here. So we have 55 patients in the efficacy of valuable set. And as Jim pointed out, after the most recent data cut off, we just registered another[inaudible] Okay, that's helpful. This is also something I missed. But when will your HGG data come out, your next data set for that? And how's about starting the timing for phase one for the alpha-nitter actinium? Sure, I have Andrei talked to the pediatric high grade guilloma study and then Jarrod can address or work with our achinium based program.

Speaker Change: Andrei Shustov, James Caruso, Jarrod Longcor, Andrei Shustov, James Caruso, Andrei Shustov,

Jarrod Longcor: And that means that you're likely to get a broader label and a label like what Jim just described, the relapse refractory. I'll turn it over to Andrei for any other questions. Thank you, Jarrod. Ahu, thank you for this question. It's a very important question that we're discussing internally, and I'm completely aligned from a clinical perspective with my colleagues, that our data is supportive of broad applicability in clinics of this hypothesis in WM patients. As described in our poll, the population in global WAM contains patients post-chemo, post-BTKI, post-retox, exposed to couples of those classes, all of those classes, and different genomic profiles.

Speaker Change: Thank you, Jarrod. I will thank you for this question. It's a very important question that we're discussing internally, and I'm completely aligned from clinical perspective with my colleagues.

Speaker Change: that our data is supportive of broad applicability in clinics of hypophysin in WM patients. As described in our poll, population in Clover WAM contain patients post-chemo, post-BTKI, post-retox, exposed to...

Speaker Change: Couples of those classes, all of those classes.

Andrei Shustov: So, the data is highly applicable clinically to the entire WM population, and clinically, again, supports the proposed label that Jarrod discussed, and more importantly, applicability once and if a hypothesis is approved, applicability to a broad variety of patients with relapsed refractory WM. That's very helpful, thank you. Of course, thank you. Thank you. And your next question comes from Ted Tenthoff of Piper Sandler. Please go ahead. Your line is open.

Speaker Change: different genomic profiles.

Speaker Change: So, the data is highly applicable clinically to entire...

Speaker Change: population and clinically, again, supports the proposed label that

Jarrod Longcor: Jarrod discussed, and more importantly, applicability once and if a hypothesis is approved, applicability to a broad variety of patients with relapsed refractory WM.

Speaker Change: That's very helpful. Thank you.

Speaker Change: Of course, thank you.

Speaker Change: Thank you. And your next question comes from Ted Tentoff of Piper Sandler. Please go ahead. Your line is open.

Ted Tenthoff: Great. Thank you very much, and thanks for the update. Following up on some of the questions with respect to the NDA, I'm curious, what are the major segments that still need to be done? You've got to give some good detail on the CMC portion. Is clinical and everything else all ready to go?

Ted Tentoff: Great. Thank you very much, and thanks for the update. I'm following up on some of the questions with respect to the NDA.

Ted Tentoff: I'm curious, what are the major segments that still need to be done? You've got to do some good detail on the CMC portion. Is clinical and everything else all ready to go? Just getting a sense for what still needs to be done. Thank you.

Jarrod Longcor: Just getting a sense for what still needs to be done. Thank you. Absolutely, Chad.

Jarrod Longcor: And this is, yes, essentially all the modules are nearly complete. And when I say that, so CMC is complete, preclinical is complete, and I think module two is essentially complete.

Ted Tentoff: Absolutely, Chad, and this is, yes, essentially all modules are nearly complete and when I say that, so CMC is complete, preclinical is complete, I think module 2 is essentially complete, module 1 will be finished when we when we have the full sort of

Jarrod Longcor: Module one will be finished when we when we have the full sort of, what sort of table contents completed based on the clinical piece. So right now, where we sit, we are really wrapping up the final pieces of the clinical piece, and when I say that, what I mean is all of the other clinical components are essentially there and done. It's really just the addition of the final data reports and, essentially, the CSR from the Clover WAM study.

Speaker Change: What sort of table content is completed based off of the clinical piece? So right now what we where we sit is really wrapping up the final pieces of clinical and when I say that what I mean Is all of the other clinical components have been are essentially there and done it's really just the addition of the final data reports and this is essentially the CSR out of the

Andrei Shustov: Thanks again, Jonathan. We started enrollment in the HGG study at the very beginning of this year with patients already enrolled in the study and a few patients being screened as we speak, we anticipate that we'll provide initial look initial results from that study by the end of the year. Okay, and then starting phase one. Yeah, no, great, great question, Jonathan. So, real fast, what I'd say is, you know, we sit in a unique advantage in that our phospholipid ether delivery targeting mode is validated, you know, based on eye-opolucine data as a validated targeting ligand, and we have a unique advantage in that that allows us to accelerate our timelines into clinical trials and completion of IND enabling studies.

Jarrod Longcor: So as that data comes in and gets put into the NDA, that essentially will wrap it up, and that's exactly as I tried to describe in the conversation earlier; that's where that detail comes in, that process of going from having the data to finalizing the data and having a locked database and all the analytics. And then would you guys anticipate having a panel for this? I know it'll probably take some time, but what are your thoughts on that?

Speaker Change: out of the Clover Wham study. So as that data comes in and gets put into the NDA, that essentially will wrap it up. And that's exactly, you know, as I tried to describe in the...

Speaker Change: in the conversation earlier, you know, that's where that detail comes in, that process of going from final, going from, you know, having the data to finalizing the data and having a locked database and all the analytics completed.

Ted Tenthoff: Thank you. And when you, Ted, just so that I understand, when you mean a panel, are you thinking of an ODAC? Yeah, it's an advisory committee, correct? Yeah, so, so, you know, obviously that that's something we will come to eventually. I wouldn't be surprised if there was an ODAC request or a desire by the agency to have an ODAC. As you may be aware, many of the radiopharmaceuticals have not actually had an ODAC.

Speaker Change: And then, would you guys anticipate having a panel for this? I know it'll probably take some time, but what are your thoughts on that? Thank you.

Andrei Shustov: As I think as we mentioned before, we expect to complete the IND enabling studies here in the fourth quarter of this year and either late this year or early next year initiate that phase one study with the actinium program. Lincoln, Jarrod, we haven't talked about it very much.

Speaker Change: And when you, Ted, just so that I understand, when you mean a panel, are you thinking of an ODAC?

Ted Tentoff: Yes, advisory committee, correct.

Jarrod Longcor: Could you share a little bit about the OG program? Yeah, absolutely. So, yeah, obviously, as Jim just alluded to, Jonathan, you know, we've gotten, you know, as we talked about, we've validated with a number of different isotopes or different emitting isotopes. And as Jim just said, we also have the advantage of being able to use OG emitting isotopes quite readily. And we do have a program that has been in the background for a while that we're moving forward with that we would expect that we could quickly initiate a phase one study in that arena as well shortly on the heels of the actinium pending a capital.

Speaker Change: Yeah, so, so, you know, obviously that that's something.

Jonathan Aschoff: Okay, that answers my questions. Thank you guys. All right. Thank you, Jonathan.

Speaker Change: We will come to, eventually, I wouldn't be surprised if there's an ODAC request or a desire by the agency to have an ODAC.

Jarrod Longcor: They've gone through without that. However, you know, we're not. We're flexible with that. I don't know, Atre, if there's anything else you'd like to add. Yeah, thank you, Jarrod, and thank you, Ted. A great question, and we, again, keep discussing this continuously internally. Our efficacy data looks, from our perspective, really impressive and great. Tolerability and safety data is also impressive. Having said that, it depends on the composition of the FDA panel that reviews it and how comfortable they are with the disease they're looking at, whether they need additional advice from the panel. I think it's a toss-up at this point from a clinical perspective.

Speaker Change: As you may be aware, many of the radio pharmaceuticals have not actually had an ODAC, they've gone through without that. However,

Speaker Change: You know, we're not, you know, we're flexible with that. I don't know.

Speaker Change: Patrick, is there anything else you'd like to add?

Speaker Change: Thank you Jarrod and thank you Chad. Great question and we again keep discussing this.

Patrick: continuously, internally. Our efficacy data looks, from our perspective, really impressive and great.

Speaker Change: Tolerability and safety data is also impressive. Having said that, it depends on the composition of FDA panel that reviews it and how comfortable they are experienced with a disease they're looking at, whether they need additional advice from from the panel.

Jeffrey Jones: And your next question comes from Jeff Jones of Oppenheimer. Please go ahead. Your line is open. Hi guys. And thanks for taking the question. A couple from me, Andre, you gave a really long and really detailed update on the data and obviously key up there with the increase in the MMRRR. Were there any other changes that we that I might have missed from the prior data set that was described into line?

Speaker Change: I think it's a toss-up at this point from a clinical perspective. We will continue to prepare for it. We are putting groundwork, assuming that it might be necessary to go through. We will be ready.

Andrei Shustov: We will continue to prepare for it. We are putting the groundwork in. Assuming that it might be necessary to go through it, we will be ready. Great. Sounds good.

Ted Tenthoff: Thank you so much. All right. Thank you, Ted. I appreciate your question.

Speaker Change: Great, sounds good. Thank you so much.

Speaker Change: All right, thank you, Ted. Appreciate your questions.

Operator: Thank you, and at this time, there are no further questions in the queue. I will now turn the call over to Jim Caruso for closing remarks. Thank you, operator. I would certainly like to thank our analysts and everyone for joining us today. We look forward to speaking with you, hopefully, in the near term. Thank you. Thank you, everyone. This concludes today's conference call. You may now disconnect.

Jeffrey Jones: Thank you, Jeff. I don't think you missed anything. This is the single most impactful update, even though it's just one additional response. It brings us closer to our previously reported number within margin of error. So the current MMRR effectively is 58.2 and we expect that we might have in the next few months additional responses converting from minor to major responses as we model at the beginning of the year. But where we sit now is 58.2% and that's the most impactful update from a month ago.

Speaker Change: Thank you and at this time there are no further questions in the queue. I will now turn the call over to Jim Caruso for closing remarks.

Jim Caruso: Thank you, operator. I would like to thank certainly our analysts and everyone for joining us today. We look forward to speaking with you, hopefully in the near term. Thank you.

Speaker Change: Thank you everyone. This concludes today's conference call. You may now disconnect.

Jeffrey Jones: Thank you. In terms of the NDA filing, one of the major reasons folks have been getting, you know, refusal of the files or rejections have been on the CMC side. So you talked about a lot about the importance of supply chain and how you built redundancy in your supply chain. But can you speak to the level of confidence in the NDA? Yeah, absolutely. So that's great question, Jeff. And there's a lot to unpack in that.

Jeffrey Jones: So I'll try to unpack as much as I can in a little bit of time here. But so as it comes to our confidence, we are highly confident for a number of reasons, not least, which, you know, we've done. We've been producing, I have probably seen at these facilities for a while now, particularly one of those facilities. We've been producing and have not missed a single batch in over three years. As I exemplified, we replicated that process and the second facility have produced multiple batches now a number of batches at that facility without any hitches as well.

Jeffrey Jones: So we're very confident in the robustness of the ability to do the tech transfer and of both manufacturing facilities to actually produce the material as defined inside the criteria as necessary for release. In addition to that, again, we've done that from the beginning to the end of things. And like anything, we use a design sort of approach with our manufacturing that allows us to get controlled by design sort of quality by design sort of approach.

Jeffrey Jones: So we're always looking to optimize and enhance that a little by little. So that's part of it. The other piece that I think we've done is, you know, when we started this process, we actually, and I'm going to get in a little bit too much detail probably, but we took this outside of our hands and we actually had an outside group come in and do a gap analysis on our entire manufacturing process from beginning to end to identify any potential gaps and any historical areas that we would need to backfill for questions.

Jeffrey Jones: We might want to answer to make sure our submission was as robust as possible. And we did that. One of those folks that was actually a gentleman who used to work at the FDA and had actually established a lot of their radio pharmaceutical manufacturing criteria. So we were we were taking a very robust look at that and we've gone through that and we continue to sort of reassess it. Now, as you as you have an unsated the last piece is, you know, the audits, as I'll call them, whether that be pre FDA audits or regular audits, we do our own regular audits both by our team and by external teams.

Jeffrey Jones: Every couple years with all of the sites we've done that and we can see and right now we've done it with everybody leading into the FDA submission. To your point, we are with every one of our manufacturers right now. We do have on the books the plan to do pre FDA pre NDA evaluations so that when they do get audited, we will have already gone through there again just to make sure and you know tightness screws so that everything is above board and appropriate.

Jeffrey Jones: So Perfect. Thank you very much for that, Jarrod. And then one very quick clarification for the Actinium-based program in solid tumors. The carrier there is the same as Iopopistone, correct, or is it a modification? There is a modification, but what I would say is that it's about 90%, 90%, 95%, depending on what chemists you ask, the same. There are slight tweaks. Okay, so in essence, the targeting agent is the same. Exactly. Got it. Great. Thanks, guys. All right. Thank you, Jeff. We appreciate your questions. And obviously, you know, you're continued interest and support of the company. Thank you.

Ahu Demir: And your next question comes from Ahu Demir of Lidenberg, Kalman. Please go ahead. Your line is open.

Unknown Executive: Good morning. This is tone for Ahu Demir. Thank you for taking all questions. We also have a question regarding the NDA applications. So for the application, what population are you targeting? Will be three line clients. But patients treated with the BTK inhibitor before. It will be double all triple refractory patients. And are there any additional analysis that the company plan to do, prior to the submission?

James Caruso: Thank you. Okay. I think prior to handling it over to Jared and Andre for their perspective and optics here. You know, as we originally designed the study, it was for a third line or greater originally post BTKI. Based on the patient population and role that supported that, it's essentially a relapse for factory patient population. And so, you know, it is our belief that we have an opportunity as we continue to engage with the FDA, that our data package would be supportive of a relapse refractory indication or essentially second line, and beyond.

James Caruso: And so I can have Jared and Or Andre provide both the regulatory and some of our clinical thinking around that. I think from a regulatory perspective, you know, if you look at the patient population, as Jim said, and as Andre defined or described to you in the, when you look at the patient characteristics, you can clearly see that this is a highly relapse refractory patient population, whether you want to cut it from post BTKI, which essentially is BTKIs and predominantly being used in the first line these days.

James Caruso: Kind of element to whether you just want to say, let's just look at the refractory. I think the key element there is, as Andre stated, the data shows that irrespective of the patient population, the drug works consistently and robustly in all of these patients. And because of that, when the agency or any agency evaluates the drug based off of that, and they start to do subanalyses, what you see is there's really no change in the patient population or the response rates.

James Caruso: And that means that you're likely to get a broader label and a label like what Jim just described, the relapse refractory. I'll turn it over to Andre for any other defaults. Thank you, Jarrod. Thank you for this question. It's a very important question that we are discussing internally, and I'm completely aligned from clinical perspective with my colleagues that our data is supportive of broad applicability in clinic,[inaudible] I apologize, I apologize Great.

Unknown Executive: Sounds good. Thank you so much.

Unknown Executive: All right. Thank you, Ted. Appreciate your questions.

James Caruso: Thank you, and at this time there are no further questions in the queue. I will not turn the call over to Jim Caruso for closing remarks. Thank you operator. I would like to thank certainly our analysts and everyone for joining us today. We look forward to speaking with you. Hopefully in the near future. Thank you. Thank you, everyone.

Unknown Executive: This includes today's conference call.

Unknown Executive: You may now disconnect.