Cellectar Biosciences, Inc.

Ladies and gentlemen, thank you for standing by, and welcome at this time. All participants are in listen-only mode. Following the presentation, there will be a question and answer session. Please be advised that today's conference call may be recorded. I would now like to hand the conference call over to Anne-Marie Fields, Managing Director at Precision AQ. Please go ahead.

Thank you, Joelle. Good morning and welcome to Selectar Biosciences' third quarter 2024 financial results and business update conference call. Joining us today from Selectar are Jim Caruso, President and CEO, who will provide an overview of the company's progress before turning the call over to Chad Coleyan, CFO, for a financial review of the quarter. Following this, Andrei Shustov, Senior Vice President, Medical, will provide an update on the Clover-WAM development program, and Shane Leah, Chief Commercial Officer, We'll review the market opportunity in WM along with the company's plans for expected commercial launch. Finally, Jared Loncar, Chief Operating Officer, will give an update on the company's progress and plans for its promising clinical development pipeline of radiopharmaceuticals. SelectArt issued a press release earlier this morning detailing the content of today's call. A copy can be found on the investor page of SelectArt's corporate website. I want to remind callers that the information discussed on the call today is covered under the safe harbor provisions of the Private Securities Litigation Reform Act. I caution listeners that management will be making forward-looking statements. Actual results could differ materially from those stated or implied by our forward-looking statements due to risks and uncertainties associated with the business. These forward-looking statements are qualified in their entirety by the cautionary statements contained in today's press release and in our SEC filings. The content of this conference call contains time-sensitive information that is accurate only as of the date of this live broadcast, November 18, 2024. We undertake no obligation to revise or update any forward-looking statements to reflect events or circumstances after the date of this conference call and webcast. As a reminder, this conference call and webcast are being recorded and archived. We will begin the call with prepared remarks and then open the line for your questions. With that, let me turn the call over to Jim Caruso. Jim?

Thank you, Anne-Marie, and thank you all for joining us this morning. The exceptionally positive data reported from our Clover WAM study represents a game-changing outcome for SelectR and an event that we can accurately characterize as transformational for the future of the company. We remain focused on the NDA submission for iFocusing I-131 in Walton Strongs and our planned product launch in the second half of 2025. To date, we have made meaningful progress toward commercial readiness and have analyzed the WM market and the role of all associated constituents, such as patients, payers, and providers. Importantly, we have efficiently advanced our platform technology through potential high-value yielding targeted investment and research collaborations, creating the option to initiate near-term Phase I and II clinical study opportunities based on business conditions and cash position. The Clover WAN study outcomes demonstrating an impressive 56.4% major response rate, a clinically relevant 80% overall response rate, and 98.2% clinical benefit rate are particularly compelling when you consider that Clover-WAM was conducted in the most heavily pretreated WM patient population ever evaluated in a clinical study. As such, it was not surprising to have been selected for an oral presentation at the upcoming American Society of Hematology's annual meeting, or ASH. ASH is the healthcare industry's most prestigious hematology congress and provides an exceptional platform to share new data from our WM pivotal study. These outcomes will be showcased in a podium presentation by Dr. Sikandar Alawade, Professor of Medicine, Division of Hematology Oncology, Departments of Medicine and Cancer Biology, at the Mayo Clinic and the principal investigator for the Clover Wham study. With these compelling data in hand, we have engaged the FDA, are constructing our NDA, and remain focused on submitting the application. Based on ongoing discussions with the FDA, we have very recently determined that, unfortunately, our NDA submission will be pushed from December of this year to likely the back end of the first quarter of 2025 and potentially into Q2. That said, given our accelerated approval designation, which provides review and determination within approximately six months of filing, we maintain our timeline for potential market approval and the launch in the second half of 2025. We will provide additional regulatory pathway clarity in today's prepared statements and as requested in the Q&A session. Our sales, marketing, and operation teams continue to construct and execute our commercial plan and will be prepared for the U.S. market launch. We have made substantial progress, most recently securing our second Iopopocene I-131 fit and finish manufacturing source, which provides additional production capacity and product supply redundancy at large. Long-term, we view expansion of iFocucine I-131 to other indolent lymphomas as smart, cost-effective, and low-risk investments with the potential to meaningfully increase the overall top-line revenue opportunity. Our collaboration with the City of Hope evaluating iFocucine and mycosis fungoides is an example of this approach. We also strongly believe that radiotherapeutics will continue to increase in importance for the treatment of cancer with both the pharmaceutical industry and oncology-focused provider networks continuing to aggressively invest in infrastructure necessary to support anticipated growth in demand for novel radiotherapeutics. Our pipeline includes preclinically validated phospholipid radiotherapeutic alpha and OG isotope conjugates for the treatment of solid tumors and offer significant potential to catalyze and drive company value in the next phase of growth beyond IFO. Now, let me turn the call over to Chad Colleen for review of our potentials.

Chad? Thank you, Jim, and good morning, everyone. Recently, we filed amended financial statements for fiscal years 2023 and 2022, an action that was precipitated by a re-evaluation of the accounting for the warrants and preferred stock we issued prior to 2023. At the time they were issued, these warrants and preferred stock were classified as permanent equity based on our assessment and supported by third-party expert evaluations. In August, the company determined that the equity classification should be changed to liability classification for the warrants and to temporary, or mezzanine, equity for the preferred stock, necessitating the revision in our historical reporting. It is important to note that the restatement did not impact cash or cash burns. And the changes to historical earnings were all non-operating and non-cash, with the exception of a minor reclassification of R&D expenses to G&A. Turning to our financial results for the period ended September 30, 2024, we ended the quarter with cash and cash equivalents of $34.3 million, compared to $9.6 million as of December 31, 2023. Our cash on hand at the end of September includes the funds raised in July 2024 from investor exercises of tranche B warrants and purchase of new warrants that have the potential to raise up to an additional $73.3 million. All major investors from the September 2023 financing exercise their tranche B warrants at a reduced as converted common stock price of $2.52 per share which was the closing price on the date of exercise. Those investors also received new warrants as part of the transaction, generating gross proceeds of 19.4 million and net proceeds after customary fees and expenses of 17.5 million. We expect that cash on hand is adequate to fund budgeted operations into the second quarter of 2025. The three warrant tranches issued in July provide additional funding based upon their respective expiration dates, which occur with a first tranche of approximately $17.0 million after we receive a PDUFA date from the FDA, a second tranche of approximately $32.9 million after we receive approval via Prophecy and 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 iapophysing I-131. Research and development expenses for the three months ended September 30, 2024, were approximately $5.5 million, compared to approximately $7.0 million for the three months ended September 30, 2023. The overall increase in R&D was primarily a result of decreased clinical study costs driven by the conclusion of patient enrollment in our WM Pivotal study having occurred earlier this year, partially offset by increased activity in our ongoing pediatric trial and an increase in personnel costs. General and administrative expenses for the three months ended September 30, 2024 were $7.8 million, compared to $2.4 million for the same period in 2023. The increase in G&A was primarily driven by costs associated with the development of infrastructure necessary to support commercialization upon the anticipated NDA approval, including the related market development and personnel costs. Net other expenses were approximately $1.4 million in the quarter just ended, while they were approximately $8.1 million in the same period last year. These expenses are almost exclusively non-cash and are a result of the timing of the financing and the valuation of the warrants issued. The only cash component to the other category is interest income, which for the quarter improved to approximately $0.3 million from $0.1 million previously. Net loss for the period ended September 30, 2024, was $14.7 million, or $0.37 per basic share and $0.40 per fully diluted share, compared with $17.5 million, or $1.55 per basic and fully diluted share, during the same period in 2023. I will now turn the call over to Dr. Schustaff. Thank you, Chad.

And good morning, everyone. Our lead asset, Hypophycin I-131, is a small molecule phospholipid radio conjugate, or PRC, designed to provide targeted delivery of iodine-131 directly to cancer cells while limiting exposure to healthy cells. We believe Hypophycin has a profile that differentiates it from many traditional on-market and in-development treatments as demonstrated by the pivotal study results from GlobalWEM. Iopophicin has received both fast-track and orphan drug designation for WM from the FDA. In July, we provided an update on the top-line results from our GlobalWEM pivotal study evaluating Iopophicin I131 in Waldenstrom's macroglobulinemia. GlobalWEM is a global, single-arm, Phase 2B study examining hypofysin I131 in relapsed and refractory WM patients who 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. Patients enrolled in CloWEM were the most heavily pretreated and the most refractory WM patient population ever reported in clinical studies. The study is fully enrolled with all living patients who have completed study treatment remaining in long-term follow-up. Based on the demonstrated Clover-Wem study results, we believe iapophysin has the potential to become the first-in-class and best-in-class radiotherapeutic agent to address the high clinical need for relapsed refractory WM patients. In October, We were delighted to share this initial compelling results in an oral presentation at a prestigious 12th international workshop on Waldenstrom's macrophlogonemia, or IWWM. WM experts from around the globe had the opportunity to review and discuss the global WM data and provide insights on the future utilization of iapophysin, assuming FDA and EMA approvals. In addition, An iapophysin case study report was presented by Jorge Castillo, MD, Associate Professor of Medicine, Harvard Medical School, and Clinical Director, Bing Center for Waldenstrom's Macroglobulinemia at the Dana-Farber Cancer Institute. His review highlighted the complete central nervous system clearance in relapsed refractory Benil syndrome BNS patient treated with iapophysin I131. BNS is a rare, life-threatening complication of WM that manifests in the central nervous system, or CNS. It typically translates into various neurologic sequelae, such as neuropathy, headaches, visual disturbances, changes in gait, partial paralysis, and is associated with poor outcomes. So while a single patient case study This was an encouraging result and an interesting case to evaluate as up to 30% of patients diagnosed with BNS die within the first three years of the diagnosis. Moreover, this response supports hypofysin I131 ability to cross the blood-brain barrier, which gives us greater confidence in the potential for similar outcomes in our pediatric high-grade glioma patients. As noted earlier, We are honored to have our ClovoVAMP data highlighted in an oral presentation at this year's American Society of Hematology, or ASH, conference, where Dr. Sikanda Alawade will be presenting the latest study data. The ASH presentation provides a tremendous opportunity to share these promising results with the very physicians who care for WM patients in the peer-to-peer discussion forums. Beyond the clinical success with iapophicin and WM, we have compiled a rich data set in relapsed refractory multiple myeloma with response rates in the 30% to 60% range in a variety of refractory patient populations. Iapophicin I131 has received FDA FAST-TRAC and orphan drug designation, and the European Commission also granted orphan drug designation to iapophicin for treatment of relapsed refractory MM. Building on hypofysin's exciting clinical results, known radio sensitivity of the related lymphoid malignancies, as well as established legacy of beta-emitting radioisotopes, iodine I131 in particular, in indolent and aggressive lymphomas, further clinical development of hypofysin in these cancers may be warranted. Mature analysis of the lymphoma cohort from Selectar's completed Phase IIa study will provide guidance to further refine our lymphoma franchise strategy. To this end, we recently announced our collaboration with the City of Hope Cancer Center, a world-renowned oncologic center and one of the largest cancer research and treatment institutions in the U.S. The collaboration will focus on the clinical development of hypofysin I131 and mycosis fungoides. the most common subtype of cutaneous T cell lymphomas, and a form of non-Hodgkin lymphoma, or NHL. MF affects the skin and, in some patients, internal organs and blood. Hypophycin is the first systemic targeted radiotherapeutic to be assessed for cutaneous T cell lymphomas, which are known for their high radio sensitivity and acute clinical need. This investigator-sponsored trial will evaluate 10 patients and is planned to initiate in early 2025. This is a great opportunity to showcase iapophysin's clinical benefits in yet another hematology oncology indication and a high degree of clinical interest of iapophysin. And support for this prestigious institution is more than encouraging. Finally, a brief mention for our ongoing development in solid tumors, particularly in pediatric high-grade gliomas. The Phase 1b study of iapophysin in these high-need cancers now has seven clinical sites with patient enrollment ongoing. Observing activity in pediatric brain cancers provides further evidence of the ability of iapophysin to cross the blood-brain barrier and deliver therapeutic payloads to sanctuary sites, such as the CNS. This feature maintains the potential to be applicable to a multitude of primary and secondary CNS malignancies. With that, I will turn the call over to Shane for the commercial update.

Thanks, Andre, and good morning, everyone. As both Andre and Jim mentioned, we are excited to have a strong presence at this year's ASH, beginning with the oral session highlighting the CloverWAM outcomes. and including a series of outreach initiatives with KOLs and key community doctors to enhance the visibility for Iopophocene I-131 and SelectR. In addition, we will optimize our presence at ASH with an interactive booth on the exhibit floor where conference participants can learn more about Iopophocene I-131, the Clover web outcomes, and our novel platform science. Selecting Iopophocene I-131 pivotal data as an oral presentation at such an important conference is an efficient opportunity to enhance visibility of iapofasine's novel profile. Turning now to the market opportunity for iapofasine I-131 and WM, let's begin with a review of the prevalence of WM, which in the U.S. is approximately 26,000 patients, with 1,500 to 1,900 patients being diagnosed annually. Of those, approximately 11,500 patients require treatment in the relapsed or refractory setting And there are an estimated 4,700 patients requiring third-line or greater therapy. There are approximately 1,000 patients who have exhausted current treatment options by third-line because of progression, ineligibility, or intolerance to those existing therapies. Therefore, the total addressable market for third-line or greater therapy is approximately 5,700 patients. It is important to note that there are no FDA-approved treatment options for patients progressing on BTKI therapy. BTKI therapies do not demonstrate complete response rates and require continuous treatment. Furthermore, 50% of third-line or greater patients are treated with the same or similar treatments from prior failed lines of therapy. Greater than 60% of treatments utilized are non-FDA-approved therapies. Clearly, there is an established unmet need for new FDA-approved treatments, such as ibuprofen I-131, that could provide a novel mechanism of action, broad responses, and non-continuous treatment, especially in heavily pretreated WM patients. We believe Iopofasine I-131, assuming an FDA approval, can be the new standard of care for third-liner greater therapy based on claims and market research data resulting in the capture of significant share and revenue. We continue to make progress advancing our go-to-market strategy, which is focused on radiotherapy-capable large community practices and hospitals with a high volume of WM patients. Our claims data provide visibility to the concentrated nature of the WM market with 185 accounts representing 70% of the WM opportunity. This market can be penetrated with a small, focused, integrated field team. Importantly, we believe commercializing iapofasine as the first off-the-shelf radiotherapeutic with a novel mechanism, strong clinical benefit, and non-continuous therapy will be a welcome therapeutic option for physicians who treating the relapsed refractory WM patients. Our vision is to establish a best-in-class radiotherapy experience across the provider and patient treatment journey from production to the completion of patient treatment. Iapofasine's strong clinical profile and there being no FDA-approved therapies for third-line plus treatment provide a clear opportunity to rapidly capture third-line plus patient share. Commercial team is continuing to advance on all areas key to launch success, including pricing, reimbursement, patient support, distribution, brand positioning, and site activation. Importantly, we're leveraging lessons learned from other product launches in this radiotherapy space to enhance our success. Direct interactions with community and academic providers confirm our findings from market research that physicians have a high level of interest in favorability rating for iApofacine's product profile. Let me now turn the call over to Jared for an operations update.

Jared? Thank you, Shane, and good morning to everyone. As we think about the regulatory pathway for apophysis in I-131, we believe it is important to put our data in context with other approved programs. Our major response rates for the Clover-Wim study was 56.4% in a later line of treatment, with the patients having a median of four prior lines, highly refractory, and over 70% post-BTKI. Ibrutinib's WMNDA submission had a 61.9% major response rate in an early line of treatment where patients had two prior lines and who were not considered refractory to any treatment and were BTKI-naive. We remain engaged with the FDA and are focused on the tasks required to complete our submission. The agency has acknowledged the strength of our data. Based on recent discussions regarding a potential confirmatory study, we shared with the FDA a post-full enrollment data cut, which included the primary endpoint and secondary endpoints of the study. The goal was to provide the FDA a comprehensive overview of results and supporting data to facilitate a discussion on next steps, considering iapopazine's significant response rates and durability observed in this patient population. To allow the agency sufficient time to evaluate the data, the meeting was pushed from October to November. SelectR has maintained internal submission timelines. However, we must remain flexible with the FDA, FDA's review timing and requests. As a result of this delay and subsequent impact on our submission requirements, we are revising our anticipated timeline for NDA submission from late December 2024 to late first quarter or second quarter of 2025. As mentioned earlier, the FDA is now recommending a confirmatory study. We are in active discussions exploring potential study designs, including a single-arm study like Clover-WAMP, which would align with the recommendations from our prime destination discussions with EMA. Or the FDA may request a randomized control trial and an earlier line of therapy based upon the strength of the data and the desire to broaden ibuprofen's utilization. We understand how important this program is to patients, our partners, and stockholders, and we are taking all possible steps to accelerate our timelines. We have a dedicated team working closely with the FDA and EMA to expedite the process and believe we will rapidly come to resolution on a confirmatory study design with the FDA. Despite this delay of approximately one quarter, we believe the long-term success of Iopoxine and Selectar remains unchanged, and we are committed to the rapid submission and subsequent launch of Iopoxine. Next steps are to conduct a November meeting with the FDA and reach agreement on any potential confirmatory study and submission timing. Now transitioning to our corporate development and partnering activities, over the last 18 months, there has been significant interest from large and mid-sized pharmaceutical companies in the radiopharmaceutical market. To date, these acquisitions have focused on acquiring radiopharmaceutical infrastructure. We are now observing a shift to product, asset, or platform acquisitions. Selectar remains one of the few companies with a large-stage or late-stage targeted radiotherapy with a validated delivery platform. As a result, we remained active in the evaluation of potential partnership structures. We are also evaluating collaborations that involve our early-stage programs based on the unique attributes of our platform and the fact that our business model is designed to integrate well with potential partners. I will now provide an update on our research and early development activities. As we've discussed, our development strategy is focused on three phases. The initial phase brings iFocusing I-131 to market as our first approved product, which is well underway. This phase and approach provide the data and validation supporting our expansion and targeted investment in additional phospholipid drug conjugates. The second phase is to expand our pipeline of targeted radiotherapies, both with line extensions of ibuprofen and the advancement of other isotopes, such as our alpha-emitter and OG-emitter programs. Phase three advances new verticals, such as small molecule cytotoxins, oligonucleotides, and peptide payloads. Beyond ibuprofen, we are excited with the progress we've made with our PRC franchise of alpha and OG emitting radioconjugating programs. Our novel targeted alpha therapy compounds include Actinian 5 product candidate, known as CLR121225, which has demonstrated promising therapeutic potential in several solid tumors, including pancreatic cancer, triple negative breast cancer, and ovarian cancer, justifying clinical development for these indications. Our PRC platform has the capacity to deliver any alpha emitter, and we have already tested several others, including lead 212 and acetine 211, allowing us to optimize radioisotope selection and delivery based on specific tumor biology. Said another way, we can target the right isotope for the right tumor. We plan to initiate our phase one study with CLR121, 225, and 2025. The Phase 1 trial will include an initial dosimetry component and then be a standard 3 plus 3 dose escalation study with four planned cohorts of single dose and three planned cohorts of multi-dose regimens. We are estimating that approximately 40 subjects be enrolled with safety as the primary endpoint and secondary endpoints of overall response rates and progression-free survival. We believe the drug distribution data in humans as well as positive safety data will be exciting and create strong program interest as it advances. Beyond CLR121-225, our broader strategy is to bring first and best-in-class radiotherapeutics to market to treat blood cancers and solid tumor with a range of alpha and OG and beta-emitting payloads. Our OG program has also demonstrated excellent activity in preclinical models of solid tumors. It is important to understand that our phospholipid ether targeting platform, regardless of payload, provides consistent drug distribution throughout the tumor, as well as uptake within the cell and payload delivery to the nucleus. This enhanced targeting allows for the use of isotopes with greater precision, like the OG emitters. Turning now to our supply chain, manufacturing targeted radiotherapies is both operationally and technically complex. We are proud of our manufacturing innovations and the significant progress made to ensure a multi-source supply chain across all three essential components for the manufacture and supply of radiotherapeutics, the isotope, the carrier, and the targeting ligand, and the combined finished product. Starting with our isotopes, we have adopted a strategy to contract directly with suppliers of the isotope and to establish these relationships early in our drug development process. As discussed previously, for Iapopecine I131, which utilizes iodine 131, we have relationships with and validated three separate suppliers and continue to assess additional suppliers. Our current partners provide redundancy in the isotope supply to allow scalable production of Iapopecine I131 either weekly or multiple times a week. Similar to the isotope sourcing strategy, We validated and secured our targeting ligand, or PLE, sourcing from multiple contractors. Currently, a single batch produces enough PLE to produce iFocusing I-131 at maximum forecasted sales volumes with additional capacity to support at least one other program for greater than three years. We maintain the capacity to increase PLE supply as needed. Importantly, We are also multi-sourcing Iapopecine I-131 as a fully finished, ready-to-use product. We currently have two production sites in North America that can supply approximately 200 patient doses per week with the capacity to scale to nearly 1,000 weekly doses. Last week, we were delighted to announce a long-term commercial supply agreement with SpectronRx for the manufacture of Iapopecine I-131. This collaboration expands our U.S. business relationship with SpectronRx and anticipates the utilization of SPECTRON's planned facility in Europe. As achieved with ibuprofen, we are replicating our collaborative outsourcing model with multi-sourcing the production of our development assets like CLR121-225. We are partnering with both existing and future suppliers of Actinium, which will guarantee sufficient supply of Actinium throughout the drug development process and into commercialization. This approach is being employed for a variety of radioisotopes, whether they are alpha, beta, or OJ-admitted. To that end, we recently signed a strategic master supply agreement with Northstar Medical Radioisotopes for the procurement and integration of Northstar's non-carrier-added Actinium-225 into our proprietary PLE delivery platform. As with iodine I-131, we are already sourcing Actinium from several other suppliers and However, this agreement with North Star provides a reliable and reproducible source of Actinium-225. It is our plan to contract additional producers of Actinium-225 as the program successfully advances. In addition to sourcing our finished product requirements, our outsourcing model provides additional benefits. One, we have significantly reduced the capital expenditure and future maintenance costs associated with an internal manufacturing capacity. we have demonstrated the ability to complete the IFOVC and I-131 technology transfer in a timely and efficient process to multiple sites, which allows for rapid transition into other organizations' manufacturing facilities as needed. With that overview, I'll turn the call back to Jim for closing remarks.

Thank you, Jared. As you can see, we remain sharply focused on building value and on the cusp of achieving a series of transformational moves driving near and long-term growth for SelectArc. We maintain a compelling value proposition with iAprosy and i131, with solid clinical data and a differentiated product profile to support its potential accelerated approval in WM, a disease with great unmet need, limited approved treatment options, and a significant revenue opportunity. We are preparing for a successful WM product launch for a highly scalable market, presenting minimal existing competitive sheer voice with an expected launch by a focus for the end of 2025. And we possess a unique PLE-based delivery platform which provides drug development optionality and currently maintain the option to advance two unique radiotherapy assets into the clinic for the treatment of large market solid tumors as company and market dynamics dictate. We believe the achievements we've made in 2024 are paving the way to drive growth in 2025 and beyond, and look forward to keeping you apprised of our progress. I want to take a moment to thank the dedicated and talented team here at SelectArts who are working smart and hard to support iApofacine's marketing approval and projected launch while advancing our promising pipeline of radiopharmaceuticals. I also want to thank you, our stockholders and partners on this journey, for your continued support and encouragement, as together we are changing the course of cancer treatment for patients with few, if any, viable treatment options. With that, operator, it's open to call for questions.

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 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 two. If you are using a speakerphone, please lift the handset before pressing any keys. One moment, please, for your first question. Your first question comes from Jeff Jones with Oppenheimer. Your line is now open.

Good morning, guys, and congrats on the quarter. Just following up on the commentary on FDA's interest in confirmatory studies, they have in some cases required that confirmatory studies commence prior to approval. Do you think that is a potential risk here? And in addition, as we think about confirmatory studies going on during the launch, how do you think that impacts product uptake and adoption?

Sure, Jeff. That's a very fair question. In regards to an ongoing confirmatory study prior to our capacity to submit the application. We don't believe that's the case based on direct written correspondence from the agency. And I'll turn it over to Jared to provide more specifics relative to that portion of your question.

Yeah. So, hi, Tim. What Tim's referring to is we have written correspondence from the agency that basically says what they're seeking prior to submission of our NDA is that we would have agreement around a confirmatory study, but not that the requirement as yet is not for it to be ongoing.

And then relative to the second part of your question, Jeff, in terms of potential impact on, you know, trial use and adoption of IOPOC C9131 commercially, obviously we would not anticipate the end for a confirmatory study to be significant, and of course, we would, you know, Jared, Andre, and the team would align with the EMA in terms of what the study protocol would look like, and we would anticipate a significant portion of the end, you know, regardless of the size, you know, patients being evaluated, XUS, top five, top seven EU, and some of the other sites that participated, you know, pretty actively in the Clover WAM study.

Great. And I guess just one financial question for you guys. You gave cash runway guidance. Assuming the full exercise of the $73 million worth of outstanding warrants, Where does that take you roughly as you prepare for launch?

So I think that if you look at the timeline, there will be a need to raise funds as an interim step, we believe, just given the fact that we expect the first tranche of the warrants would not really fall into the timing for exercise until we have a need to add additional cash to the coffers, as you would say. So there is an interim raise that would be required. But beyond that, once you get into the exercise of those warrants, it should provide additional funding that we believe will get us through the process. At least that's the expectation based on the current budgeted pathway.

Jeff, so if you take a look at, if we anticipate for the sake of a calendar here, an April 1 submission with a 75-day PDUFA, that hits June 15th, and that's the activation of the first tranche of warrants. So we would have a quarter bridge, and we would evaluate and continue to evaluate a number of different options that we have relative to raising funds, whether that's in the form of a traditional financing or the evaluation of some of the corporate development activities that we're currently evaluating and are ongoing that Jared will get to during his prepared statements. So we view a number of different options available to us to establish and strike that bridge. I think the other piece here that's significant is the $73 million overall you know, will satisfy our needs from a commercial launch perspective as well. And as we've talked to in the past, because of the scalable nature of the Waldenstrom market, we view, you know, a targeted sales organization with an OPEX and in and around this kind of $20, $25 million a year range as being more than sufficient to drive trial use and adoption. And that, I think, is important to note because typically in oncology spaces, you're looking at, you know, more along the lines of a $50 to $70 million a year expenditure, you know, for the effective commercialization. As you recall, not only is the space scalable, there's limited to no, you know, multinational pharmaceutical machinery in the space. There's not a lot of spend. Sheer of mind from a thought leadership perspective is highly available for us. And without this sheer of mind and competitive, air quote, detailing that you typically see in some of these more highly competitive spaces, you know, a limited investment in commercial medical marketing really yields, is high value yielding in terms of increase in trial use and adoption.

All right. Really appreciate the clarity, guys. I'll hop back into the queue. All right. Thanks much, Jeff.

Ladies and gentlemen, as a reminder, should you have a question, please press star 1. There are no further questions at this time. I will now turn the call over to Jim for closing remarks.

Okay. Thank you, operator. Again, thank you for all of you joining us today, and we look forward to keeping you appraised of our progress. Enjoy the day. Thank you.

Ladies and gentlemen, this concludes your conference call for today. We thank you for participating and ask that you please disconnect your lines.