Q1 2024 Cellectar Biosciences Inc Earnings Call

Operator: Good morning, and welcome to Cellectar Biosciences' 2024 Year-End Earnings Call. This call is being recorded.

Good morning, and welcome to select hard Biosciences, 'twenty 'twenty four year end earnings call today's call is being recorded.

Operator: Before we begin, I would like to remind everyone that statements made during this call relating to Selectar'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 Selectar.

Speaker Change: Before we begin I would like to remind everyone that statements made during this call relating to select our 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.

Speaker Change: Although the company believes that the expectations reflected in such forward looking statements are based upon reasonable reasonable assumptions actual outcomes and results are subject to risks and uncertainties that could differ materially from those forecasts due to the impact of many factors beyond the company the control of select or the.

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.

Operator: The company assumes no obligation to update or supplement any forward-looking statements, whether as a result of new information, future events, or otherwise. Participants are directed to the Cautionary Notes by Seth Forth in today's press release, which is available on the Investor Relations portion of the company's website, as well as the Risk Factors by Seth 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.

participants: Participants are directed to the cautionary notes set forth in today's press release, which is available on the Investor relations portion of the company's website.

Selector: As well as the risk factors set forth in selectors annual reports filed with the U S. E. C for factors that could cause actual results to differ materially from those anticipated in the forward looking statements.

participants: This time I would like to turn the call over to Jim Caruso, President and Chief Executive Officer of select her Mr.

James V. Caruso: Mr. Caruso. Please go ahead.

James V. Caruso: Thank you, operator. And good morning, everyone.

Speaker Change: Thank you operator, and good morning, everyone. It is my pleasure to be here with you to report our Q1 results and provide a corporate update with me today are Doctor Andre Shoe stop senior Vice President Medical Jared long core Chief operating officer.

James V. Caruso: It is my pleasure to be here with you to report our Q1 results and provide a corporate update. With me today are Dr. Andrei Shustov, Senior Vice President, Medical, Jarrod Longcor, Chief Operating Officer, Shane Lea, Chief Commercial Officer, and Chad Kolean, our Chief Financial Officer. As you know, we recently completed our 2023 Annual Earnings Call, in which we reviewed a highly productive year for the company, including the announcement of detailed top-line data from our WM Pivotal Study and reiterated guidance for a data update in Q2.

Speaker Change: <unk>, Li our Chief commercial officer, and Chad Cohen, our Chief Financial Officer.

Speaker Change: As you know, we recently completed our 'twenty two 'twenty three annual earnings call and which we reviewed a highly productive year for the company, including the announcement of a detailed top line data from our Wm pivotal study and reiterated guidance for a data update in Q2.

James V. Caruso: I am pleased to report that we remain on track for a Q2 data announcement for the fully enrolled study patient population. We plan to press release this data in June and review it in greater detail on a key opinion leader call scheduled for the same day. We look forward to sharing the study data and the subsequent KOL call. Currently, we are in the process of completing our NDA and plan to submit our filing to the FDA in the second half of this year. Assuming we are granted priority review associated with our FASTRAC designation, we would expect a six-month review period from the date of the NDA submission.

Speaker Change: I am pleased to report that we remain on track for a Q2 data announcement for the fully enrolled study patient population.

Speaker Change: We plan to press release this data in June and review in greater detail on our key opinion leader call scheduled for the same day.

Speaker Change: We look forward to sharing the study data and the subsequent K O L call.

Speaker Change: Currently we are in process of completing our M D E and plan to submit our filing to the FDA in the second half of this year.

Speaker Change: Assuming we are granted priority review associated with our fast track designation, we would expect a six month review period from the date of the NDA submission.

James V. Caruso: The focus of today's earnings call is to have a more in-depth commercial discussion regarding the attractiveness of the WM market, including the existing high unmet need, the lack of competitive investment, and scalable nature, among other factors all likely to facilitate rapid capture of Iopophycine I-131 market. In addition, we will review our efficient and cost-effective product manufacturing infrastructure and distribution plan in preparation for the potential marketing of our lead radiotherapeutic. I will provide a brief overview of the meaningful accomplishments of the company over the past first quarter. I will then transition the call to Chad to discuss our financial results. Shane will review the commercial topics, followed by Jarrod's manufacturing and distribution network update. We will then open the call for Q&A.

Speaker Change: The focus of today's earnings call is to have a more in depth commercial discussion regarding the attractiveness of the wm market, including the existing high unmet need the lack of competitive investment and scalable nature.

Pope: Other factors all likely to facilitate rapid captured by a Pope has seen I went 31 market share in it.

Pope: Additionally, we will review, our efficient and cost effective product manufacturing infrastructure and distribution plan in preparation for the potential marketing of our lead radio therapeutics.

Pope: The further Orient you to todays agenda I will provide a brief overview of the meaningful accomplishments of the company over the past first quarter I will then transition the call to Chad to discuss our financial results Shane will review the commercial topics, followed by Jared manufacturing and <unk>.

Jared: Fusion network update.

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

James V. Caruso: As you are likely aware, and as I have previously stated, it is an exciting time for companies with radiotherapeutic pipelines and those few companies with late-stage and or near-term approvable assets. With the next radiotherapeutic approval, potentially Ipofacin I-131. Along with our unique PLA delivery platform providing a differentiated radioisotope offering or offering, including alpha-emitting agents, we are confident in our position and excited about the future of Celectar. With that as a background, I will now provide a full review of our key Q1 accomplishments.

Jared: As you are likely aware and as I have previously stated it is an exciting time for companies with radio therapeutic pipelines and those few companies with late stage <unk> near term approvable assets with the next radio therapeutic approval potentially I poke has seen I 131.

Speaker Change: With our unique P. L E delivery platform, providing a differentiate it radioisotope offering or offerings, including alpha emitting agents, we're confident in our position and excited about the future of select dog.

Speaker Change: With that as background I will now provide an overview of our Q1 accomplishments.

James V. Caruso: Of course, we announced positive top-line data in the Clover Wham Pivotal Study, evaluating iopococine I131 for the treatment of relapsed refractory Waldenstrom's macroglobulemia, and as mentioned, we'll provide an update on full patient enrollment in June. As part of a private placement of up to $103 million, the company received approximately $44 million in January, with the potential to secure another $34 million in warrants available for conversion at a $4.77 strike price upon approval of our WMNDA.

Speaker Change: Okay.

Speaker Change: Of course, we announced positive top line data in the Clover Wham pivotal study evaluating a purpose I want three one for the treatment of relapsed refractory waldman strong macro globule EMEA and that site. It will provide the data update on full patient enrollment in June.

The company: As part of a private placement of up to $103 million. The company received approximately $44 million in January with the potential to secure another $34 million in warrants available for conversion at a $4.77 strike price upon approval of our W. M N D. A.

Chad J. Kolean: Importantly, to support launch preparation and potential marketing by Pofacin, we announced another strategic partnership with AON, or the American Oncology Network, a physician-led community-based, cutting-edge oncology platform that is currently managing the treatment of approximately 650 WM patients. The partnership's objective is to collectively advance the treatment of WM in the community setting through a better understanding of the WM landscape and to ensure patient access to Iopofacin I-131 for the many communities that AON serves.

The company: Yeah.

Speaker Change: Importantly to support launch preparation and the potential marketing by focusing we announced another strategic partnership with Aon or the American oncology network, a physician led community based cutting edge oncology platform that is currently managing the treatment of approximately 600.

Speaker Change: 50 W. N patients. The partnership's objective is to collectively advance the treatment of W. N in the community setting through a better understanding of the Wm landscape and to ensure patient access I approached the scene I 131 for the many communities that <unk> serves.

Speaker Change: <unk>.

Chad J. Kolean: Announced promising preclinical data for three unique internally developed alpha emitters, including our proprietary novel alpha-emitting phospholipid therapeutic conjugate, CLR-121255, an actinium-labeled phospholipid ether, and pancreatic cancer model. We are evaluating CLR121, CLR225 in additional preclinical models, such as ovarian and triple negative breast cancer, and plan to initiate a Phase I study in one of these solid tumor cancers no later than Q1 2025, reported a complete central nervous system clearance and relapsed refractory Waldenstrom's macroglobulinemia, providing further validation for ioprofacin I-131 to treat solid and hematologic tumors, including those located across the blood-brain barrier, initiated and enrolled the first patient in our Phase 1B clinical study of Iopophycine I131 in pediatric high-grade gliomas, or PHGG.

Speaker Change: Announced promising preclinical data for three unique internally developed alpha emitters, including our proprietary novel Alpha emitting phospholipid therapeutic conjugate CLR 121255, and actinium labeled phospholipid ether in pancreatic cancer models.

CLR: We are evaluating CLR 121225, and additional preclinical models, such as ovarian and triple negative breast cancer and plan to initiate a phase one study and one of the solid tumor cancers. No later than Q1 2025.

CLR: Reported a complete central nervous system clearance in relapsed refractory following storms macro globule EMEA.

unknown: Providing further validation for eye of focusing I 131 to treat solid and hematologic tumors, including those located across the blood brain barrier.

Speaker Change: Initiated and enrolled the first patient in our phase one clinical study by focusing I went 31 in pediatric high grade Gliomas or P. H G G.

Chad J. Kolean: Based on investigator excitement and Iopophycine's demonstrated activity in solid tumors across the blood-brain barrier, we are excited about the value Iopophycine may provide in this treatment setting, one in which patients are restricted to few treatment options. As previously announced, we look forward to providing an update on this study in the second half of 2024, and have reported a high rate of complete remission in an investigator-initiated phase one study of ioproposine in combination with external beam radiotherapy in another challenging solid tumor.

Investigator: Based on investigator excitement and I poke machines demonstrated activity in solid tumors across the blood brain barrier. We are excited about the value I approach as seen may provide industry and setting one in which patients are restricted to few treatment options as previously announced we look forward to providing.

Speaker Change: An update on this study in the second half of 2024.

Investigator: Reported a high rate of complete remission and an investigator initiated phase one study of <unk> in combination with external beam radiotherapy and another challenging solid tumor recurrent head and neck cancer. The complete remission rate was 64% and overall risk.

Chad J. Kolean: Current Head and Neck Cancer. The complete remission rate was 64%, and the overall response rate was 73% in a highly refractory patient population. Durability of clinical activity was also impressive, achieving 67% overall survival and 42% progression-free survival at one year. I will now turn the call over to Chad to discuss the company's funding.

Speaker Change: Sponsorship was 73% and a highly refractory patient population.

Speaker Change: The ability of clinical activity was also impressive achieving 67% overall survival and 42% progression free survival at one year.

Speaker Change: Let me now turn the call over to Chad to review the company's financials.

Chad J. Kolean: Thank you Jim.

Chad J. Kolean: Our cash-in-cash equivalence balance as of March 31, 2024 was $40.0 million compared to $9.6 million as of December 31, 2023. The Exercise of the Tranché Warp.

Chad J. Kolean: Our cash and cash equivalents balance as of March 31, 2024 was 40.0 millions compared to $9 6 million as of December 31, 2023.

Chad J. Kolean: The exercise of the tranche a warrants from the September 2023 financing combined with the exercise of 547000 warrants issued.

Chad J. Kolean: September 2023 financing, combined with the exercise of 547,000 warrants issued in October 2022, generated net proceeds of $43.9 billion. Net cash used in operating activities during the quarter was approximately $13.4 million. The company believes its cash on hand is adequate to fund budgeted operations into the fourth quarter. R&D expense for the quarter was approximately $7.4 million, compared to $6.7 million in the first quarter of 2023. As we continue our preparations for an expected product launch for the iPhone SE9131 in 2025,

Chad J. Kolean: Silver 2022.

Chad J. Kolean: Generated net proceeds of $43 9 million.

Speaker Change: Net cash used in operating activities during the quarter was approximately $13 4 million.

Speaker Change: He believes its cash on hand is adequate to fund budgeted operations into the fourth quarter of 2020.

Speaker Change: R&D expense for the quarter was approximately seven 4 million compared to $6 7 million in the first quarter of 2023.

C&I: As we continue our preparations for an expected product launch cycle C&I went 31 of 2025.

Chad J. Kolean: The company has invested extensively to ensure that we have the ability to deliver product in the event of a disruption in one of our suppliers, which we have addressed by the establishment of a multi-source supply chain that has redundancies at every step, from radioisotope suppliers to material producers and final conjugated product providers. Those costs will be partially offset by reduced spending related to our pivotal trial in WM now that we have completed trial enrollment.

McDonald's: A couple of years invested extensively to ensure that we have the ability to deliver product in the event of a disruption in one of our suppliers, which we a solution by the establishment of a multi source supply chain Mcdonald's EBIT every step.

Mcdonald's EBIT: Our radio isotope suppliers to material producers and final conjugated product providers.

Mcdonald's EBIT: Those costs were partially offset by reduced spending related to our pivotal trial AWS now that we have completed trial enrolled.

Chad J. Kolean: GNA expense for the first quarter of 2024 was $4.6 million, as compared to $2.1 million last year for the same period. This substantial increase in G&A is also primarily driven by the expectation of a product launch in 2025, with the development of the infrastructure and information necessary to support a fully commercialized product, including personnel and marketing. There is a $9.9 million non-cash charge that relates to the impact of accounting for the warrants on the P&L.

Mcdonald's EBIT: G&A expense for the first quarter of 2024, it was $4 6 million as compared to $2 1 billion last year for the same period.

Speaker Change: The substantial increase in G&A is also primarily driven by the expectation of a product launch in 2025.

unknown: With the development of the infrastructure information necessary to support a fully commercialized products, including personnel and marketing costs.

Speaker Change: There was a $9 9 billion noncash charge that relates to the impact of the accounting for the warrants on the P&L.

Chad J. Kolean: The accounting rules for the warrants require the company to revalue them at every reporting. Also, upon settlement, the tranche A warrants that were exercised in the quarter were required to be revalued as of that settlement date. The value is determined to be $4.8 million, which represents the intrinsic value of the warrants at the time of expiration.

Accounting rules: The accounting rules for the warrants requires somebody to revalue them at every reporting date.

Speaker Change: So upon subtle the tranche a warrants that were exercised in the quarter were required to be revalued at that settlement date.

Speaker Change: The value was determined to be $4 8 million, which represents the intrinsic value of the warrants at the time of exercise.

Chad J. Kolean: The difference between the stated conversion price to common of $3.185, $3.185, and the price of the stock at the time. This is booked as an expense, and then that amount is immediately reclassified to equity, as shown in the statement of stockholders' equity in the 10-Q we just filed this morning. In addition to the impact of the settlement of the Tranche A Warrants, the remaining tranche B warrants were revalued as of the end of the period, which resulted in an increase to the liability of $5.1 million. This expense is primarily driven by the increase in the stock. Combined, these two components compose the laws evaluating warrants on the people.

Speaker Change: The difference between the stated preferred the Virgin priced common of 3.185 $3 18 in the handsets and the price of the stock at the time.

Florida: This is booked as an expense and then that amount is immediately reclassified to equity as shown in the state of the stockholders' equity and the 10-Q, we just filed for Florida.

Florida: In addition to the impact of the settlement of the tranche a warrants.

Speaker Change: Gaining tranche B awards were revalued as of the end of the period, which resulted in an increase to the liability of $5 1 million.

Speaker Change: This expense is primarily driven by the increase in the stock.

Speaker Change: Combined these two components propose the loss on valuation of warrants on the P&L.

Chad J. Kolean: The net loss attributable to common stockholders for the quarter ended March 31, 2020, $21.4 million, or 74 cents per share, compared to $8.6 million or $0.76 per share last year. With that, I will now turn the call over to Shane Lea for a commercial overview. Shane? Thank you, Chad.

Speaker Change: The net loss attributable to common stockholders for the quarter ended March 31, 2024 was $21 $4 million or <unk>.

Speaker Change: 74 per share.

Speaker Change: <unk> grew to $8 6 million or <unk> 76 cents per share last year.

Speaker Change: With that I will now turn the call over to Shane Lee.

Shane Lea: Commercial or shape.

Shane Lea: Thank you Chad.

Shane Lea: The commercial team is advancing our preparation for a potential commercial launch of Ioposacin and WM. Importantly, we continue to execute and make progress supporting our commercialization strategy for Iopophazine, the goal of ensuring a successful launch upon FDA approval. We are very encouraged by the findings from our most recent market research projects, which included an evaluation of Iopophycine's product profile and evaluation of the WM patient journey and segmentation research with radiation oncologists and Nuclear Medicine Physicians.

Shane Lea: Commercial team is advancing our preparation for a potential commercial launch of <unk>.

Shane Lea: Importantly, we continue to execute and make progress supporting our commercialization strategy for <unk> the goal of ensuring a successful launch upon FDA approval.

Shane Lea: We are very encouraged by the findings from our most recent market research projects, which included an evaluation of <unk> product profile.

Wm: Valuation of Wm patient journey, and segmentation research with radiation oncologists and nuclear medicine physicians.

Shane Lea: Iopophycine's product profile for WM was given an exceptionally high rating for intent to prescribe with hematology. Key findings from our patient journey work also show patient active participation, treatment choice, and important treatment drivers, which include a need for new options and fixed therapy. We have also engaged radiation oncologists and nuclear medicine physicians since they are key stakeholders for radiotherapy utilization. The Radiation Oncologist and Nuclear Medicine Physician's Review of Iopophycine's Profile was very positive.

Hematologist: <unk> product profile for Wm was given an exceptionally high rates for attention prescribed with Hematologist key findings from our patient journey work also show patient active participation treatment choice and important treatment drivers, which includes a need for new options and fixed therapy.

Speaker Change: We have also engaged radiation oncologists and nuclear medicine physicians since they are key stakeholders for radiotherapy utilization.

Speaker Change: The radiation oncologists and nuclear Medicine Physicians review <unk> profile is very positive.

Shane Lea: They were enthusiastic about Iaquaficine's simplicity of use versus existing radiotherapeutics. I have focused on features such as no required dosimetry, short infusion time, long storage life, and ease of administration were regarded as significant differentiators by this key stakeholder group. Interactions with these key stakeholders further support our belief that iapofecine is a best-in-class next-generation radiotherapeutic that, if We are selectively building a successful and experienced commercial team that will support the framework for our go-to-market model in WM with a goal of establishing market leadership.

Speaker Change: We're enthusiastic with Iqos it seems that simplicity of use versus existing radio therapeutics.

Speaker Change: I am focusing features such as no acquired this cemetery short infusion time long storage lives and ease of administration were regarded as significant differentiators by these key stakeholder group.

Speaker Change: Interactions with these key stakeholders further supports our belief that <unk> is a best in class next generation Radiotherapeutic that if approved will secure significant utilization in both the hospital and community outpatient setting.

Speaker Change: We are selectively building a successful and experienced commercial team that will support the framework for our go to market model in W. At what the goal of establishing market leadership.

Shane Lea: We will be utilizing claims data to drive decision making that will support radiotherapy site activation, brand awareness, and ensure that the first treatment experience with diapophagy is the right experience for both patient and provider. We have initiated additional market research projects that will further support product positioning, value payer messaging, and pricing strategy. We continue to build out data capabilities to further understand the WM market, supporting a highly efficient and cost-effective commercial model.

Speaker Change: We will be utilizing claims data to drive decision, making that will support radiotherapy site activation brand awareness and ensure that first treatment experience with Io focusing the right experience for both patient and provider.

Speaker Change: We have initiated additional market research projects that will further support product positioning value payer messaging and pricing strategy.

Speaker Change: We continue to build out data capabilities to further understand the wm market supporting a highly efficient and cost effective commercial model, we believe wm as a very attractive market with no real market leadership as.

Shane Lea: We believe WM is a very attractive market with no real market leadership, is a concentrated market with a high unmet need, limited competition, and provides an opportunity to capture a significant share with active promotion utilizing FDA approval. Turning to slide three.

Speaker Change: As a concentrated market with a high unmet need and.

Speaker Change: Eliminate competition and provides an opportunity to capture significant share with active promotion utilizing FDA approval.

Speaker Change: Turning to slide three.

Shane Lea: Our third-party claims and EP data show the total USWM market to be approximately $2.1 billion, with the current relapsed refractory market valued at $1 billion. Iopophycine has two very compelling opportunities to capture patient share, assuming marketing approval. The first opportunity to capture patient share exists in the current lapse refractory market, which is burdened by high unmet need. Nearly 50% of patients in the third line or greater setting are retreated with the same or similar treatment from an earlier line due to a lack of options.

Speaker Change: Our third party claims and epic data showed that total USW market to be approximately $2 1 billion with the current relapsed refractory market valued at $1 billion I am focusing has two very compelling opportunities to capture patient share assuming marketing approval the first opportunity to capture.

Speaker Change: Sure exists in the current relapsed refractory market, which is burdened by high unmet need nearly 50% of patients in the third line or greater set of retreated with the same similar treatment from an earlier line due to lack of boxes greater than 60% of these therapies are not FDA approved and cannot be promoted.

Shane Lea: Greater than 60% of these therapies are not FDA approved and cannot be promoted. Iopophycine can be readily positioned to cap or share in the existing relapsed refractory mark. Second, we believe the third line or greater market, which is approximately 4,700 patients, could expand to 5,700 patients. This is the second opportunity for our company.

Speaker Change: <unk> can be readily positioned to capture share in the existing relapsed refractory market.

Speaker Change: Second we believe the third line or greater market, which is approximately 4700 patients could expand to 5700 patients.

Speaker Change: This is the second opportunity for ion processing.

Shane Lea: Approximately 1,000 patients have exhausted the prevalent treatment option. As a result, patients remain either ineligible or intolerant of current market treatment. This market expansion opportunity could allow fast patient capture by biofocusing as a novel WN treatment. On slide four, our claims data demonstrate there is no established standard of care in WN.

Speaker Change: Approximately 1000 patients have exhausted that prevalent treatment options as a result patients remain either an eligible or tolerate some current market treatments.

Speaker Change: This market expansion opportunity could allow fast patient captured by our focusing as a novel WN treatment.

unknown: On slide four our claims data demonstrate there is no established standard of care in Wm.

Shane Lea: As previously stated, greater than 60% of patients receive non-FDA-approved drugs, and over half, 52%, of patients who receive BTKI in the second line are re-challenged with BTKI, again, as third-line therapy. This is mainly a function of limited treatment options in the relapsed refractory setting, as there has been no FDA-approved new mechanism of action for nearly a decade. Iopophycine, with its novel mechanism of action and strong clinical profile, along with Cellectar's active promotion of Iopophycine, can capture a significant share in this market.

Speaker Change: As previously stated greater than 60% of patients received not just the approved drugs and over half 52% of patients who receive a boutique AI and the second lot of reach out to <unk>.

Speaker Change: Again as third line therapy.

Speaker Change: This is mainly a function of limited treatment options in the relapsed refractory setting.

Speaker Change: There has been no FDA approved new mechanism of action.

Speaker Change: Nearly a decade.

Select Cars: <unk> with its novel mechanism of action and strong clinical profile, along with select cars active promotion of <unk> can capture significant share in this market.

Shane Lea: Slide 5, Market Claims Data, confirms consistent and significant recycling of existing therapy. According to claims data, 10% of third-line patients receive the chemotherapeutic drug Vendobustine, and approximately 40% of these patients are re-challenged with that chemotherapy in later life. Approximately 1,600 patients received rituximab in the third line or greater setting, and more than 50% were retreated with rituximab after prior exposure. There is only one class of approved drugs and only two FDA-approved therapies in this class, which includes Abrutinib and Xanabrutinib.

Select Cars: Slide five market claims data confirms consistent and significant recycling of existing therapies. According to claims data 10% of third line patients received a chemotherapeutic drugs into busting and approximately 40% of these patients are re challenged with that chemotherapy is the later lines.

Select Cars: Approximately 600 patients receive from <unk> in the third line or greater setting and more than 50% are retreated with rituximab after prior exposure.

Speaker Change: There is only one class of approved drugs and only two FDA approved therapies in this class, which includes a brute nib as ibrutinib.

Shane Lea: Third-party claims data also validates approximately 50% of BTKI patients retry PTKIs in the third line or greater set. As previously stated, nearly 50% of 4,700 patients in the third line or greater setting have been retreated after prior exposure to that same therapy. The consistent recycling of therapies is due to the lack of treatment options.

Speaker Change: Third party claims data also validates approximately 50% of <unk> patients.

Speaker Change: <unk> in the third line or greater said.

Speaker Change: As previously stated nearly 50% of <unk> 4700 patients in the third line or greater setting have been retreated after prior exposure to that same therapy.

Speaker Change: The consistent recycling if there is due to the lack of treatment options market characteristics for existing therapies underscores the unmet need.

Shane Lea: Market characteristics for existing therapies underscore the unmet need, and nearly all are not actively promoted. According to market research, WMT opinion leaders and treaters express a need for a novel mechanism of action, a fixed course of therapy, and better efficacy outcomes. We believe iupofazine can address these stated preferences upon FDA approval. However, pricing analog evaluation for other therapies and total cost of care with continuous therapy can cost over $1 million. This provides significant optionality for Iopophycine premium prices.

Speaker Change: And nearly all are not actively promoted.

Speaker Change: According to market research Wm key opinion leader ship and Treaters expressed a need for a novel mechanism of action fixed course of therapy and better efficacy outcomes. We believe <unk> can address these stated preferences upon FDA approval.

Speaker Change: Pricing analog evaluation for other therapies and total cost of care with continuous continuous therapies.

Speaker Change: Cost over $1 million this.

Speaker Change: <unk> significant optionality for <unk> premium pricing as noted earlier, we have initiated our pricing work that will provide the optimal recommended price.

Shane Lea: As noted earlier, we have initiated our pricing work that will provide the optimal recommended price. Lastly, slide six is a high-level illustration of our approach to execution. The WM market is highly concentrated with approximately 80% of diagnosed patients in 15 states. Additionally, 75% of second-line or greater patients are treated in only 199 accounts.

Speaker Change: Lastly, slide six is a high level illustration of our approach to execution.

Speaker Change: The Wm market is highly concentrated with approximately 80% of diagnosed patients in 15 states.

Speaker Change: 75% of second line or greater patients are treated and only a 199 accounts.

Shane Lea: This concentrated nature of the market supports a commercial strategy that will leverage geographic and account segmentation to optimize share of voice with the right customer at the right time to drive awareness and quickly capture patient share. In conclusion, our commercial planning efforts are advancing with the objective of executing a successful launch and establishing Ipofacin as a market share leader in WM. We look forward to providing additional information. I will now turn the call over to Jarrod Longcor to highlight our manufacturing and distribution. Jarrod. Thank you, Shane.

Speaker Change: This concentrated nature of the market supports a commercial strategy that will leverage geographic and account segmentation to optimize share of voice with the right customer at the right time to drive awareness and quickly capture patient share.

Speaker Change: In conclusion, our commercial planning efforts are advancing with the objective of executing a successful launch and establishing <unk> as a market share leader in Wm.

Jerry Jarrett: We look forward to providing additional updates I will now turn the call over to Jerry <unk> to highlight our manufacturing and distribution Jarrett.

Jarrod Longcor: Historically, targeted radiotherapeutics have faced significant supply and manufacturing challenges, primarily due to limited finished product manufacturing locations, constrained availability of isotopes, the isotope half-life, and limited shelf life of the finished product, resulting in manufacturing and patient treatment bottlenecks. Additionally, targeted radiotherapies have been expensive to manufacture with significant challenges in scalability to match market demand. At Cellectar, we've implemented multiple strategies to avoid many, if not all, of these pitfalls.

Jerry Jarrett: Thank you Shane historically targeted radio therapeutics have faced significant supply and manufacturing challenges primarily due to limited finished product manufacturing locations.

Jerry Jarrett: Strained availability of isotopes.

Path Labs: Path Labs, and limited shelf life of the finished product, resulting in manufacturing and patient treatment bottlenecks. Additionally, targeted radiotherapy had been expensive to manufacture with significant challenges and scalability to match market demand.

Select Door: At select door, we've been supplying at multiple strategies to avoid many if not all of these pitfalls.

Jarrod Longcor: Unlike other models, we've adopted a flexible modular manufacturing strategy. This approach offers scalability and addresses various challenges in traditional manufacturing methods. Instead of relying on a single Selectar-operated manufacturing facility, our modular approach utilizes a network of overlapping suppliers and contractors. This tactic reduces the overall footprint and operating costs of one or multiple manufacturing facilities, significantly lowering Fixed Capital Expenditure.

Select Door: Unlike other models, we've adopted a flexible modular manufacturing strategy. This approach offers scalability and addresses various challenges in traditional manufacturing methods instead of relying on a single select our operated manufacturing facility a modular approach utilizes a network of overlapping suppliers and contractors.

Select Door: <unk>.

Speaker Change: This tactic reduces the overall footprint operating cost of one or multiple manufacturing facilities significantly lowering fixed capital expenditure.

Jarrod Longcor: Furthermore, by validating multiple suppliers for every component of our product, we have mitigated issues related to constrained source isotopes, the targeting ligands, and limited finished product manufacturing capabilities. Our modular approach enables rapid increases in supply to meet market demands. Currently, we can supply over 200 doses per week of ibuprofen I-131 with the capability to quickly scale up to over 1,000 patient doses per week without expanding our existing infrastructure. This means we can effectively serve the needs of nearly 20,000 patients per year without additional investment.

Speaker Change: Furthermore, by validating multiple sclerosis every component of our product we have mitigated issues related to constrained source isotope targeting like ants and limited finished product manufacturing capabilities.

Speaker Change: Our modular approach enables rapid increases in supply to meet market demands currently we can supply over 200 doses per week or by focusing I 131, with the capability to quickly scale up to over 1000 patient doses per week without expanding our existing infrastructure. This means we can effectively serve the needs of nearly two.

Speaker Change: 20000 patients per year without additional investment. Additionally, a modular supply chain allows for further expansion of this market as the market grows.

Jarrod Longcor: Additionally, our modular supply chain allows for further expansion of the market as the market grows, with capacity to nearly double current supply and plans to place, Plans in place for over a 50% increase in supplies with the addition of at least one more facility. Securing our supply chain was the first step in our plan to improve the availability of IFOs. In addition, we have invested in optimizing production processes, enhancing yield, and reducing costs.

Speaker Change: With capacity to nearly double current supply and plans to place.

Speaker Change: Plans in place for over a 50% increase in supply with the addition of at least one more facility.

Speaker Change: Securing our supply chain was the first step in our plan to improve the availability of by focusing in addition, we have invested in optimizing production processes enhancing yield and reducing costs exploring alternative production methods has increased flexibility and scalability. These efforts have resulted.

Jarrod Longcor: Exploring alternative production methods has increased flexibility and scalability. These efforts have resulted in a more robust process, improved product quality, increased production capacity, and a novel formulation providing an industry-leading 17-day shelf life. These developments have also generated new intellectual property and technologies applicable to future radiotherapeutic programs like our Actinium or Alpha Emitter programs. Our ModFlip reduction strategy extends to our logistics chain and physician provider network, aiming to provide the most flexible and accessible options for patients and physicians.

Speaker Change: In a more robust process improved product quality increased production capacity and a novel formulations, providing a industry, leading BD 17th day shelf life. These developments have also generated new intellectual property and technologies applicable to future radiotherapeutic programs like <unk> or <unk>.

BD: Alpha emitter program.

Speaker Change: Our module slip reduction strategy extends to our logistics chain in physician provider network and you can provide the most flexible and accessible options for patients and physicians, while regulatory restrictions by the NRC in F. D. A to dictate where patients can access targeted radio therapies. We have designed this system to provide broad access.

Jarrod Longcor: While regulatory restrictions by the NRC and FDA dictate where patients can access targeted radiotherapies, we have designed a system to provide broad access. We are committed to working closely with both community-focused oncology networks and hospital systems to ensure the availability of eye-focusing I-131 for their patients. You can expect to learn more about these strategic approaches during our upcoming June data release and KOL call. I will now turn the call over to Jim for closing remarks. Jim. Thank you.

James V. Caruso: We are committed to working closely with both community focused oncology networks and hospital systems to ensure availability of I, focusing I wonder if anyone for their patients you can expect to learn more about the strategic approaches during our upcoming June data release, and Kols call I will now turn the call over to Jim for closing remarks.

BD: Okay.

Jim: Thank you Jarrett.

James V. Caruso: As you can see, the first quarter of 2024 has been highly productive. In terms of WM, we continue to assemble our NDA submission, judiciously constructed, talented, and highly efficient commercial infrastructure, and further refine an already advanced manufacturing infrastructure and distribution model. Of course, we also look forward to sharing our WN Pivotal study data in June. Additionally, I would also like to highlight the utility of our PLE delivery platform, as further demonstrated by ongoing internal and collaborative R&D work with a variety of oncology payloads, including small molecules, peptides, and oligos.

James V. Caruso: As you can see the first quarter of 2024 has been highly productive.

James V. Caruso: In terms of Wm, we continue to assemble our NDA submission.

James V. Caruso: Judiciously construct a talented and highly efficient commercial infrastructure and further refine and already advanced manufacturing infrastructure and distribution model.

Jarrett: Of course, we also look forward to sharing our Wm pivotal study data in June.

Speaker Change: I would also like to highlight the utility of our PLE delivery platform is further demonstrated by ongoing internal and collaborative R&D.

Speaker Change: With a variety of oncology payloads, including small molecules peptides and Oligos, we plan to rapidly advance our lead Alpha emitter asset CLR 121225, and actinium based phospholipid radio conjugate or PRC into a solid tumor phase one study.

James V. Caruso: We plan to rapidly advance our lead-alpha emitter asset, CLR121225, an actinium-based phospholipid radial conjugate, or PRC, into a solid-tumor Phase I study no later than Q1 of 2055. And, of course, we remain optimistic regarding the potential of Ipofacin I-131 in pediatric high-grade gliomas, and we'll provide an update on our Phase 1b With that, I would now like to open the call up for our Q&A session.

James V. Caruso: No later than Q1 of 2025.

Speaker Change: And of course, we remain optimistic regarding the potential by focusing I went 31 in pediatric high grade Gliomas and will provide an update on our phase <unk> study the second half of 2024.

James V. Caruso: With that I will.

Speaker Change: I'd now like to open the call up for our Q&A session.

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, you'll hear a prompt that their hand, that's been raised.

Operator: 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 lift the handset before pressing any keys.

Speaker Change: Should you wish the decline from the polling process. Please press star followed by the number of cool.

Speaker Change: If you are using a speaker phone please lift the handset before pressing any keys.

Speaker Change: Okay.

Operator: Your first question is from the line of Ahu Demir from Leidenberg-Talman. Please go ahead.

Speaker Change: Your first question is from the line of AHU Demir from Ladenburg Thalmann. Please go ahead.

Ahu Demir: Good morning, everyone. Thanks for all the color that you provided. A couple follow-up questions on the commercial side. Can you give us a sense of, number one, the FDA filing timeline, where you are at, and what the timeline that you are looking at? And the second portion of the question is, have you hired any sales members? What will be the first target given the commercial effort? And the third part of the question is about the pricing. Could you provide a little bit more color on the pricing? What should we take as a basis?

Ahu Demir: Good morning, everyone. Thanks for all the color that you provided a couple of follow up questions on the commercial side.

Ahu Demir: Can you give us a sense on number one the FDA filing timeline there you are right.

Ahu Demir: What is the timeline that you are looking at and number two portion of the question is have.

Speaker Change: Have you hired any sales members what will be the first target given the commercial last word.

Speaker Change: The third part of the question is on the pricing could you provide a little bit more color on the pricing what should we take as a base.

James V. Caruso: All right. Terrific, Ahu. First of all, thank you for your participation in the call today. I very much appreciate it.

Speaker Change: Alright, terrific, Scott, who first of all thank you for your participation in the call today very much appreciate it.

James V. Caruso: In terms of the regulatory filing timeline, you know, our guidance remains consistent with the second half of this year. As you know, based on our FDA fast-track designation and the market itself, and FDA precedent in terms of how they recently treat it like assets, we have a high degree of comfort that we'll receive a six-month, approximately a six-month review. Sometimes the FDA may go a little bit longer and leak into, you know, seven months or so, but we believe that's a six-month review and have a high degree of comfort around that.

Speaker Change: In terms of the regulatory filing timeline.

Speaker Change: Guidance remains consistent with the second half of this year as you know based on our FDA fast track designation and the market itself and FDA precedent in terms of how they.

Speaker Change: Recently treated like assets, we have a high degree of comfort that we'll receive for six months.

Speaker Change: Approximately a six month review, sometimes the FDA may go a little bit longer and weekend to seven months or so, but we believe that's a six month review.

Speaker Change: Have a high degree of comfort around that before prior to transitioning over to <unk>.

James V. Caruso: Before transitioning over to Shane to kind of review briefly how selectively we've been approaching the attraction, recruitment, and hiring of highly talented commercial people, Folks, I will say that we're being very, very judicious in terms of how we think about the commercial opportunity. And based on the scalable nature of the market, we can be highly targeted. And a limited investment goes a real long way here.

Shane: Shane to kind of review briefly how selectively we've been approaching.

Shane: The attraction.

Shane: Recruitment and hiring.

Shane: Highly talented commercial.

Shane: Vote.

Speaker Change #100: You know I I.

Shane: We'll say that we're being very very judicious in terms of how we think about the commercial opportunity and based on the scalable nature of the market. We can be highly targeted and limited investment goes a real long way here. So we will have Shane talk to that in greater detail and then relative to the pricing. We believe we have.

James V. Caruso: So we'll have Shane talk about that in greater detail. And then, relative to pricing, we believe we have the opportunity to charge a premium price in this market. That supports that, as well as, quite frankly, our early market research and pricing work. So with that, I'll turn it over to Shane.

Shane: Opportunity to premium price in this market, there's a number of benchmarks that support that as well as quite frankly, our early market research.

Shane: And pricing work, so with that I'll turn it over to Shane Thanks for.

Shane: Yeah. Thanks, Jim I'll address the question around the sales so as stated.

Shane Lea: earlier. We're leveraging segmentation in our approach. We want to be very smart in terms of a very targeted approach to take advantage of this opportunity. And so we're still in the process of refining and understanding exactly where we're going to target our efforts. We feel very confident that we're going to be able to put in a highly talented sales team that will be able to drive awareness and eventually trial use and adoption. So again, we feel very, very good about that.

Shane Lea: Earlier, we were leveraging segmentation in our approach we want to be very smart in terms of.

Shane: Very targeted approach to take advantage of the opportunity and so we're still in the process of.

Shane Lea: Refining and.

Shane: Understanding exactly where are we going to target our efforts.

Speaker Change: We feel very confident that we're going to be able to place in a highly talented.

Speaker Change: Sales team that will be able to drive awareness and eventually trial use and adoption. So again, we feel very very good about that again all of our decision, making making is being driven by data. So that it's a very targeted and we're leveraging our efforts most effectively and we're allowed to do that based on the concentrated nature of this market which is it.

Shane Lea: Again, all of our decision making is being driven by data so that it's very targeted, and we're leveraging our efforts most effectively. And we're allowed to do that based on the concentrated nature of this market, which is a unique opportunity. The second thing I'll add, just to echo the comments from Jim, again, we have orphan drug designation; a rare disease like WM is very good for us in terms of optionality around premium pricing, especially with policy provisions that are in place.

Speaker Change: Unique opportunity.

Shane Lea: Second thing I'll add just to echo the comments, Jim again, we have orphan drug designation rare disease like W.

Jim: Is very.

Jim: Good for us in terms of Optionality around premium pricing, especially with policy provisions that are in place we feel confident looking at other analogues in the marketplace, both continuous therapy and other radio therapeutics that we'll be able to place.

Shane Lea: We feel confident looking at other analogs in the marketplace, both continuous therapy and other radiotherapeutics that will be able to place a price that will be effective and support high value for the organization. And then, in terms of your question relative to, you know, contract sales organization or the type of commercial model that we would employ, everything's on the table at this particular point in time. We're evaluating, you know, the most cost-effective and most productive approaches.

Jim: Place a price that will be effective and support high value for the organization and then in terms of your question relative to contract sales organization or the type of commercial model that we would employ.

Speaker Change #101: Everything's on the table at this particular point in time, we are evaluating the most cost effective and most productive approaches.

Shane Lea: Typically, with a CSO model, you would hire your own leadership, you know, internally and then, you know, farm out, you know, the sales specialist or other radiotherapeutic nuclear radon specialists via a CSO. We're evaluating the costs associated with both and the capacity to drive trial use and adoption with a hypothesising variety of different commercial models. So it'll be cost efficient. We will secure, you know, the best talent, and we're, as I mentioned earlier, highly comfortable and confident in our capacity to field a highly productive commercial organization. Thank you for attending.

Speaker Change #110: Typically with a CSO model.

Speaker Change #105: You would hire your own leadership.

Shane Lea: Internally and then farm out.

Jim: Shale special based or other Radiotherapeutic nuclear ride ons specialist.

Speaker Change #108: Our CSO and we're evaluating the costs associated with with both and capacity to drive trial use and adoption with IPO proceeds.

Speaker Change: Variety of different commercial models, so it'll be cost efficient we will secure the.

Jim: The best talent.

Jim: And we're as I would mentioned earlier, we're highly comfortable and confident in our capacity.

Jim: To fields.

Highly productive commercial organization.

Unknown Attendee: Thank you for taking my question.

Jim: Thank you for taking my question.

Speaker Change #104: Of course, thank you.

Speaker Change #104: Yes.

Jim: Yeah.

Operator: Ladies and gentlemen, just a reminder, if you have any questions, please press star one and the telephone keypad. Your next question is from the line of Jeff Jones from Oppenheimer. Your line is now open.

Ladies and gentlemen, just a reminder, if you have any questions. Please press star one on the telephone keypad.

Speaker Change: Your next question is from the line of Jeff Jones from Oppenheimer. Your line is now open.

Jeffrey Michael Jones: Good morning, guys, and thanks for taking the call. One follow-up question on pricing and a couple on the Waldenstrom's trial data. On pricing, you mentioned some of the analogs you're looking at. Could you share, you know, perhaps, what some of those examples are?

Jeffrey Michael Jones: Good morning, guys and thanks for taking the call.

Jeffrey Michael Jones: One follow up question on pricing.

Jeffrey Michael Jones: And a couple on the Walgreens from trial.

Jeffrey Michael Jones: Data.

Speaker Change #106: On pricing you mentioned, some lumpy and along shared we're looking at.

Analyst: Could you share.

Jeffrey Michael Jones: Perhaps what some of those examples are and then on the Waltons for some data that were anticipating in now in June.

Jeffrey Michael Jones: And then on the Waldenstrom's data that we're anticipating now in June, what should we be expecting from that update? For example, the number of additional patients will be that you think you're going to share data on. And also, from the prior data set, there were three patients with near-CRs. Can you comment on what the hurdle is for those to convert, and if any of those have converted since the January update?

Jeffrey Michael Jones: What should we be expecting from that update for example, the number of additional patients will be.

Analyst: That you think you're going to share data on.

Analyst: And also from the prior data set there were three patients with the near Crs.

Jeffrey Michael Jones: Can you comment on what the hurdle is for those to convert and if any of those who have converted since the January update.

James V. Caruso: All right, Jeff. Of course. Thank you, Jeff. Again, appreciate your participation in today's call and for the, you know, the three questions that we'll triage here. I will say based on the clinical data, and I'll have Andrei talk to that initially in terms of what we're going to provide, at this point, you know, we, you know, are likely not going to provide any color relative to the updated information, but to your point, it will be consistent in terms of that data that we previously shared, and Andrei is closer to this than to anyone as he, you know, consolidates our data at this point in time, so I'll turn it over to Andrei to provide his color and things.

Jeff: Alright, Jeff here.

James V. Caruso: Of course, thank you Jeff again appreciate your participation in today's call and for the you know the three questions that we'll triage here I will say based on the clinical data and I'll have Andre talked to that initially in terms of what we're going to provide at this point you know we.

Andre: You know are likely not going to provide any color relative to the updated information.

Jeff: But to your point it will be consistent.

James V. Caruso: In terms of that data that we previously shared and Andreas.

Andrei: Andre is closer to this than anyone has she.

James V. Caruso: Consolidates our data at this point in time, so I'll turn it over to Andre to provide his color and thinking.

Andrei Shustov: Thank you, Chairman. Jeff, good morning. Thank you for your question.

Andre: Thank you gentlemen, jam packed with morning. Thank you for your question.

Speaker Change: Certainly looking forward to confirming the exciting results we've put in the cockpit domain in January specifically.

Andrei Shustov: We're certainly looking forward to confirming the exciting results we put in the public domain in January, specifically the rate of responses, overall response, major response, deep responses, as well as durability in the form of duration of response. We are determining, based on current data cleaning, the right time to do time-dependent variable analysis. As you probably recall, we rolled a Sizeable fraction of patients at the very back end of the study in the third and fourth quarter of 2023.

Andrei Shustov: The rate of responses overall response major response.

Andrei Shustov: Responses as well as.

Andrei Shustov: Durability and a form of five duration of response, we are determining based on current data cleaning the right timing to do time dependent medical analysis, as you'll probably recall withdrawal.

Speaker Change: Sizable fraction of patients in the very back end of the study and a third in the fourth quarter of 2023. So this patient.

Andre: Or.

Andrei Shustov: Some of them treated in 2024, so to avoid doing very early censoring, we got pushed out the time dependent variable analysis.

Andrei Shustov: So this patient were some of them treated in 2024, so to avoid doing very early censoring, we Pushed out the time-dependent variable and also like duration of response at the back end of the first quarter, but we are planning to update that So to answer more directly the first part of your question, we will be reporting on response rate, including types of responses and durability of response, at the time of our announcement.

Andrei Shustov: Duration of response.

Andrei Shustov: To the backend of the first quarter, but we are planning to update that so to answer more directly first part of your question we will be.

Andrei Shustov: Our reporting on response rate, including.

Types of responses and durability of response.

Andrei Shustov: That at the time following announcement.

Andrei Shustov: So, as you recall, Jeff, we had 41 patients that we reviewed with the top line data. Now we'll have full enrollment in the mid-50 range. I can give you more color on that.

Speaker Change: So as you recall, Jeff we had 41 patients that we had.

Andrei Shustov: You know reviewed with the topline data now will have the full enrollment.

Speaker Change: In the mid 50 range I can give you color on that and so you know it's a significant increase in number of patients and as I think Andre appropriately mentioned, we'll have a.

James V. Caruso: And so it's a significant increase in the number of patients. And as I think Andrei appropriately mentioned, we'll have a better line of sight on durability, certainly for those patients that were enrolled earlier in this study. Relative to pricing, you know, we clearly have an opportunity to charge a premium in this space based on our market research, initial pricing work, as well as, you know, in discussions with advisory boards built around pharmacy benefit managers from large third-party payers.

James V. Caruso: A better line of sight on durability certainly for those patients that were enrolled earlier in this study.

James V. Caruso: Relative to our pricing.

James V. Caruso: We clearly have an opportunity to premium price in this space based on our market research initial pricing work as well as.

James V. Caruso: In discussions with our advisory boards built around pharmacy benefit managers from large.

James V. Caruso: Third party payers I think it's also fair to say approximately 70% to 75% of these patients will be reimbursed via Medicare Medicare I'm.

James V. Caruso: I think it's also fair to say approximately 70 to 75% of these patients will be reimbursed via Medicare. So that gives us a lot of optionality and flexibility as well. But looking at pricing benchmarks, I'll turn that over to Shane to provide some color.

James V. Caruso: So that gives us a lot of optionality and flexibility as well, but you're looking at pricing.

James V. Caruso: Pricing benchmarks I'll turn that over to Shane to provide some color yes. Thanks, Jim So as I stated earlier, we're also.

Shane Lea: Thanks, Jim. So, as stated earlier, we're also in the process of really drilling into our value messaging and pricing work. But, you know, as we're looking at certain pricing analogs, certainly, we're looking at a wide range of products which I think best represent rare disease treatment categorization. So, for example, CAR-T, Exedra for theochromocytoma, as well as BTKI therapy, NWM, looking at its costs from a total cost of care perspective.

Shane Lea: In the process of really drilling into our value messaging and pricing work.

Shane Lea: As we're looking at certain pricing and <unk> certainly we're looking at a wide range of <unk>.

Speaker Change: <unk>, which.

Shane Lea: I think best represents a rare disease treatment categorization.

Shane Lea: So for example car T.

Shane Lea: At G drafts for pheochromocytoma as.

Speaker Change: As well as <unk> therapy and Wm.

Shane Lea: At its core from a total cost of care perspective.

Shane Lea: Yeah, so Jeff, we believe we can put together a really nice health value message around the pharmacoeconomic kind of story here based on the durability, you know, the four limited infusions and then the durability of that treatment as well as, as you recall, you know, treatments will no longer require therapy for an extended period of time, which means no adverse events, unlike other therapies that are continuous, where clinicians share with us, they're constantly, it's a constant battle to manage the adverse events associated with some of these products that are taken more consistently.

Jeff: Yeah. So Jeff we believe we can put together a really nice health value message around pharmacodynamic.

Shane Lea: Kind of story here based on the durability.

Shane Lea: For limited infusions, and then the durability of of that treatment.

Speaker Change: As well as as you recall.

Shane Lea: You know patients will no longer require a therapy for an extended period of time, which means no adverse events.

Shane Lea: Like other therapies that are continuous where clinicians or share with us they're constantly it's a constant battle to manage the adverse events associated with some of these products that are taken more consistently.

Unknown Executive: Great, I really appreciate that additional color, guys. Our pleasure, Jeff.

Speaker Change: Great really appreciate that additional color guys.

Unknown Executive: Our pleasure, Jeff. Thank you.

Unknown Executive: Our pleasure Jeff Thank you.

Operator: Your next question is from the line of Jonathan Aschoff from Roth. Your line is now open.

Speaker Change: Your next question is from the line of Jonathan Aschoff from Ross. Your line is now open.

Jonathan Matthew Aschoff: Good morning, guys. I guess what you left me to ask is, you know, what can you share about the ex-US negotiations, maybe what those potential collab, you know, partners might be waiting for before getting any more deep into those kinds of discussions?

Jonathan Matthew Aschoff: Hi, Good morning, guys I guess.

Jonathan Matthew Aschoff: Please let's move to ask is what can you share about ex U S negotiations, maybe what those.

Jonathan Matthew Aschoff: <unk> club partners might be waiting for before getting any more deep into those kind of discussions.

Jonathan Matthew Aschoff: Okay.

James V. Caruso: It's a great question, Jonathan. Obviously, you know, there's consistency, I will say this, there's consistency among third parties that we are collaborating with on our delivery platform and those that are interested in promoting this product, XUS, and we're taking both a regional approach as well as a larger kind of global approach to this, and so I'll turn it over to Jarrod, who's been our oversight and leadership in this area.

Jonathan: So great question, Jonathan Obviously, you know.

James V. Caruso: Yeah.

James V. Caruso: There is consistency I will say this there's consistency among.

Jarrod Longcor: Third parties that we are collaborating with on our delivery platform.

Jarrod Longcor: And those that are.

James V. Caruso: Are interested in promoting this product ex U S and we're taking both a regional approach as well as a more a larger kind of global approach to this and so I'll turn it over to Jarrett who's been our providing oversight and leadership in this area.

Jarrod Longcor: Yeah, Jonathan. What I would say is, you know, we continue to advance those dialogues. We're in deep discussions with a number of parties in different regions, as Jim alluded to, and we continue to evaluate additional regional partnerships for certain components. And then, as Jim said, we also are engaged in dialogues with folks that are, what I'd say, is more... Well, a global sort of strategy. So we are consistently advancing both, you know, in parallel, advancing both lines of thinking and both opportunities and trying our best not to let one run too far in advance of the other.

Jarrod Longcor: Yeah Jonathan.

Jarrod Longcor: Well, what I'd say is you know we continue to advance those dialogues we're in deep discussions with a number of parties in different regions as Jim alluded to.

Jarrod Longcor: And we continue to evaluate additional regional partnerships for certain components and then as Jim said, we also are engaged in dialogues with folks that are.

Jarrod Longcor: What I'd say is more.

Jarrod Longcor: Well global sort of a strategy and so we are consistent.

Jarrod Longcor: Consistently advancing both.

Jarrod Longcor: In parallel events in both lines of thinking and both opportunities.

Jarrod Longcor: And trying our best not to let one run them too far in advance of the other.

Jarrod Longcor: And can you tell me if you're getting any... On the clawback provisions that you had said that you insisted would be doable at a low price for you, you know, do they not want those at all or at the kind of limited premium that we require, as you mentioned earlier?

Speaker Change: And can you tell me if youre getting any.

Speaker Change: The Clawback provisions that you had said that you insisted would be doable at a low price for you did.

Speaker Change: Do they not want.

Jarrod Longcor: That was at all or at the kind of limited premium or we acquired that.

Jarrod Longcor: Mentioned earlier.

Jarrod Longcor: Yeah, if I'm following where your question is going, yes, if we do a partnership for a particular region, yes, we were, we are incorporating into those the ability to pull back the asset if we were to structure a larger, broader deal with certain, you know, obviously, premiums on investment by the partner.

Speaker Change: Yeah, if I'm following where your questions going yes, if we if we do a partnership for a particular region.

Jarrod Longcor: Yes, we were we are incorporating into those the ability to pull back the asset if we were structuring larger broader deal.

Jarrod Longcor: With certain you know obviously <unk>.

Jarrod Longcor: Premiums on investments by the partner.

Shane Lea: Okay, and then, although you were asked twice before on this call about, you know, pricing, did you, or did you not list any specific drugs that you were comparing yourself to when you use the word premium?

Jarrod Longcor: Okay, and then although you're asked twice before on this call about.

Shane Lea: Pricing did you or did you not list any specific drugs that you were comparing yourself to when you use the word premium pricing.

Shane Lea: I believe we stated CAR T. Yeah, I think so. As stated, mentioned the various CAR T therapies, a range of different analogs that we're looking at for These treatments, Exedra, which is another one for pheochromocytoma, is one which we're looking at. And as mentioned before, with earnings calls in previous, we're also looking at BTKI therapy, the total cost of care for these continuous therapies. Yeah. So BTKI is typically, let's just say approximately $1 million. I think Exedra was $600,000. And then your CAR T's are pretty much between that range.

Shane Lea: Okay.

Speaker Change: I believe we stated the car T. Please yes, yes, I think so as stated.

Shane Lea: Mentioned, the various car T therapies is a range of different analogs that we're looking at.

Shane Lea: For.

Shane Lea: This is.

Shane Lea: Treatments.

Shane Lea: At G draw is another one for pheochromocytoma is one which we're looking at and as mentioned before.

Shane Lea: With earnings calls previous we're looking also at <unk> therapy. The total cost of care for these continuous therapies. So BT chaos typically lets just say approximately $1 million I think the Z drove was 600 $600.

Shane Lea: And then your car Ts are are pretty much between that range.

Jonathan Matthew Aschoff: Okay, thank you very much, guys. All right, Jonathan.

Shane Lea: Okay. Thank you very much guys.

Unknown Executive: All right, Jonathan. Thanks much.

Jonathan: Alright, Jonathan Thanks much.

Unknown Executive: Yeah.

Unknown Executive: Okay.

James V. Caruso: This time there are no further questions in the queue. I will now turn the call over to Jim Caruso for closing remarks. Please go ahead.

Unknown Executive: At this time there are no further questions in the queue I will now turn the call over to Jim Caruso for closing remarks. Please go ahead.

Operator: Okay. Thank you, operator. I certainly would like to thank everyone for joining us today. I appreciate the questions, and we look forward to speaking with you in the near future. Thanks again. Have a good day.

James V. Caruso: Okay. Thank you operator.

James V. Caruso: Certainly we'd like to thank everyone for joining us today appreciate the questions and we look forward to speaking with you in the near term. Thanks.

Operator: Thanks, again have a good day.

Operator: Ladies and gentlemen, this concludes today's conference call. Thank you very much for your participation. You may now disconnect.

Speaker Change: Ladies and gentlemen. This concludes today's conference call. Thank you very much for your participation you may now disconnect.

Operator: Okay.

Operator: Yeah.

Operator: [music].