Cellectar Biosciences (NASDAQ: NASDAQ:CLRB) announced in its Third Quarter 2024 Earnings Call that it has postponed the New Drug Application (NDA) submission for its therapeutic candidate iopofosine I 131 to the first or second quarter of 2025.
The company, led by President and CEO Jim Caruso, cited discussions with the FDA regarding a confirmatory study as the reason for the delay. Despite this, Cellectar reported positive data from its CLOVER WaM study and plans for a product launch in the second half of 2025.
Financially, the company is in a stronger position with $34.3 million in cash and equivalents and has raised funds to support operations into mid-2025.
Key Takeaways
- NDA submission for iopofosine I 131 delayed to Q1/Q2 2025.
- Positive CLOVER WaM study data showed significant response rates in WM patients.
- Cellectar is preparing for a second-half 2025 product launch.
- The company has improved its cash position to $34.3 million.
- Research and development expenses decreased, while administrative expenses increased.
Company Outlook
- Cellectar plans to expand iopofosine I 131's applications in indolent lymphomas.
- The company is working on collaborations to advance its radiopharmaceutical pipeline.
- A Phase 1 study for CLR-121225 is planned for 2025.
Bearish Highlights
- NDA submission delay could impact the company's timeline for product launch.
- The company anticipates the need for interim funding before exercising outstanding warrants.
Bullish Highlights
- Cellectar raised $19.4 million through warrant exercises, bolstering its financial position.
- The company has secured multiple suppliers for isotopes and targeting ligands.
- Fast Track and Orphan Drug designations from the FDA may expedite iopofosine I 131's approval process.
Misses
- Net loss for the quarter was $14.7 million, though this was an improvement from the prior year.
Q&A Highlights
- The company discussed international clinical evaluations, particularly in the EU.
- There was mention of various fundraising options to support commercial launch needs.
- Operational expenditure for the launch is estimated to be significantly lower than typical oncology expenditures.
In summary, Cellectar Biosciences has delayed its NDA submission for iopofosine I 131 as it discusses a confirmatory study with the FDA. The company remains optimistic, with solid study data and financial strategies to support its operations and upcoming product launch.
Cellectar continues to foster partnerships and expand its pipeline, with plans to start new trials and capitalize on the scalable WM market. The company has committed to keeping stakeholders informed on its progress.
InvestingPro Insights
Cellectar Biosciences' recent earnings call and strategic decisions can be further contextualized with real-time data from InvestingPro. The company's market capitalization stands at $63.45 million, reflecting its current position in the biotech sector. Despite the positive outlook presented in the earnings call, InvestingPro data reveals some challenges facing the company.
An InvestingPro Tip indicates that Cellectar is "quickly burning through cash," which aligns with the company's anticipation of needing interim funding before exercising outstanding warrants. This cash burn rate is critical, especially considering the delayed NDA submission and the extended timeline to potential product launch in 2025.
Another relevant InvestingPro Tip notes that the "net income is expected to drop this year." This expectation correlates with the reported quarterly net loss of $14.7 million, even though it was an improvement from the previous year. The company's financial position is further illuminated by its adjusted operating income of -$47.67 million for the last twelve months as of Q2 2024, underscoring the ongoing investment in research and development typical of biotech firms in the pre-revenue stage.
The stock's recent performance has been challenging, with InvestingPro data showing a 6-month price total return of -46.36% and a year-to-date return of -36.1%. This downward trend is reflected in the InvestingPro Tip that the stock is "trading near 52-week low," which may be of interest to investors looking for potential entry points.
For those seeking a more comprehensive analysis, InvestingPro offers 14 additional tips for Cellectar Biosciences, providing a deeper dive into the company's financial health and market position.
Full transcript - Cellectar Biosciences Inc (CLRB) Q3 2024:
Operator: 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.
Anne Marie Fields: Thank you, Joelle. Good morning, and welcome to Cellectar Biosciences Third Quarter 2024 Financial Results and Business Update Conference Call. Joining us today from Cellectar are Jim Caruso, President and CEO, who will provide an overview of the company's progress before turning the call over to Chad Kolean, CFO for a financial review of the quarter. Following this, Andrei Shustov, Senior Vice President, Medical (TASE:PMCN), will provide an update on the CLOVER WaM development program; and Shane Lea, Chief Commercial Officer will review the market opportunity in WM along with the company's plans for expected commercial launch. Finally, Jarrod Longcor, Chief Operating Officer will give an update on the company's progress and plans for its promising clinical development pipeline of radiopharmaceuticals. Cellectar issued a press release earlier this morning detailing the content of today's call. A copy can be found on the investor page of Cellectar'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?
Jim Caruso: 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 Cellectar and an event that we can accurately characterize as transformational for the future of the company. We remain focused on the NDA submission for focusing I 131 in Waldenstrom’s 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 1 and 2 clinical study opportunities based on business conditions and cash position. The CLOVER WaM 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 pre-treated 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. Sikander Ailawadhi, Professor of Medicine, Division of Hematology, Oncology, Departments of Medicine and Cancer Biology at the Mayo Clinic, and the Principal Investigator for the CLOVER-WaM study. 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 backend 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 iopofosine I 131 fit and finish manufacturing source, which provides additional production capacity and product supply redundancy at launch. Long-term, we view expansion of iopofosine 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 iopofosine 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 Auger isotope conjugates for the treatment of solid tumors and offer significant potential to catalyze and drive company value and the next phase of growth beyond iopofosine I 131. Now let me turn the call over to Chad Kolean for a review of our financials. Chad?
Chad Kolean: 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 reevaluation 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 burn, 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 the 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 of iopofosine 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 iopofosine 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 and 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. Shustov.
Andrei Shustov: Thank you, Chad, and good morning, everyone. Our lead asset iopofosine 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 iopofosine has a profile that differentiates it from many traditional on-market and in-development treatments as demonstrated by the pivotal study results from CLOVER-WaM. Iopofosine 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 CLOVER-WaM pivotal study evaluating iopofosine I 131 in Waldenstrom's macroglobulinemia. CLOVER-WaM is a global single arm Phase 2b study examining iopofosine I 131 in relapsed and refractory WM patients who received at least two prior lines of therapy, including those patients who failed or had some optimal response to BTKi, the only FDA approved class of treatment for this cancer. Patients enrolled in CLOVER-WaM were the most heavily pre-treated 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-WaM study results, we believe iopofosine 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 macroglobulinemia, or IWWM. WM experts from around the globe had the opportunity to review and discuss the CLOVER-WaM data and provide insights on the future utilization of iopofosine assuming FDA and EMA approvals. In addition, an iopofosine 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 Bing-Neel syndrome, BNS, patient treated with iopofosine I 131. 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 four 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 died within the first three years of the diagnosis. Moreover, this response supports iopofosine I 131's 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 CLOVER-WaM data highlighted in an oral presentation at this year's American Society of Hematology or ASH Conference, where Dr. Sikander Ailawadhi will be presenting the latest study data. The ASH presentation provides a tremendous opportunity to share this promising results with the very physicians who care for WM patients in a peer-to-peer discussion form. Beyond the clinical success with iopofosine and WM, we have compiled the rich data set in relapsed/refractory multiple myeloma with response rates in the 30% to 60% range in a variety of refractory patient populations. Iopofosine I 131 has received FDA Fast Track and Orphan Drug designation, and the European Commission also granted orphan drug designation to iopofosine for treatment of relapsed/refractory WM. (ph) Building on iopofosine's exciting clinical results, known radio sensitivity of the related lymphoid malignancies, as well as established legacy of beta emitting radioisotopes, Iodine I-131, in particular, in indolent and aggressive lymphomas, further clinical development of iopofosine in these cancers may be warranted. Mature analysis of the lymphoma cohort from Cellectar's completed Phase 2a 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 iopofosine I 131 in mycosis fungoides, the most common subtype of cutaneous T-cell lymphomas in the form of non-Hodgkin lymphoma, or NHL. MF affects the skin and, in some patients, internal organs and blood. Iopofosine is the first systemic targeted radio therapeutic 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 iopofosine's clinical benefits in yet another hematology oncology indication and a high degree of clinical interest of iopofosine, 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 iopofosine in this high need cancers now has seven clinical sites with patient enrollment ongoing. Absorbing activity in pediatric brain cancers provides further evidence of the ability of iopofosine to cross (ph) 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.
Shane Lea: Thanks, Andrei, and good morning, everyone. As both Andrei and Jim mentioned, we are excited to have a strong presence at this year's ASH, beginning with the oral session highlighting the CLOVER-WaM outcomes and including a series of outreach initiatives with KOLs and key community doctors to enhance the visibility for iopofosine I 131 and Cellectar. In addition, we will optimize our presence at ASH with an interactive booth on the exhibit floor where conference participants can learn more about iopofosine I 131, the CLOVER-WaM outcomes, and our novel platform science. Selecting iopofosine I 131 pivotal data as an oral presentation at such an important conference is an efficient opportunity to enhance visibility of iopofosine's novel profile. Turning now to the market opportunity for iopofosine 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/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 in eligibility 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 iopofosine I 131 that could provide a novel mechanism of action, broad responses and non-continuous treatment, especially in heavily pretreated WM patients. We believe iopofosine I 131, assuming an FDA approval, can be the new standard of care for third-line or 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 iopofosine as the first off-the-shelf radio therapeutic with a novel mechanism, strong clinical benefit and non-continuous therapy will be a welcome therapeutic option for physicians treating their 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. Iopofosine'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 and favorability rating for iopofosine's product profile. Let me now turn the call over to Jarrod for an operations update. Jarrod?
Jarrod Longcor: Thank you, Shane, and good morning to everyone. As we think about the regulatory pathway for iopofosine I 131, we believe it is important to put our data in context with other approved programs. Our major response rates for the CLOVER-WaM's 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, Ibrutinib's WM NDA submission had a 61.9% major response rate in an earlier 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 our 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 iopofosine'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. Cellectar has maintained internal submission time lines; however, we must remain flexible with the FDA, FDA review timing and requests. As a result of this delay and subsequent impact on our submission requirements, we are revising our anticipated time line 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-WaM, which would align with the recommendations from our prime designation discussions with EMA, or the FDA may request a randomized controlled trial in an earlier line of therapy based upon the strength of the data and the desire to broaden iopofosine'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 time lines. We have a dedicated team working closely with the FDA and EMA 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 iopofosine and Cellectar remains unchanged, and we are committed to the rapid submission and subsequent launch of iopofosine. Next (LON:NXT) steps are to conduct the 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. Cellectar remains one of the few companies with a large stage or late-stage targeted radio therapy with a validated delivery platform. As a result, we believe -- we remain 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 iopofosine 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 iopofosine and the advancement of other isotopes such as our alpha emitter and Auger emitter programs. Phase three advances new verticals, such as small molecule cytotoxins, oligonucleotides and peptide payloads. Beyond iopofosine, we are excited with the progress we've made with our PRC franchise of alpha and Auger emitting radioconjugate programs. Our novel targeted alpha therapy compounds include actinium 225 (ph) product candidates known as CLR-121225 which has demonstrated promising therapeutic potential in several solid tumors in 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 let to 12 and Astatine 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 1 study with CLR-121225 in 2025. The Phase 1 trial will include an initial dosimetry component and then via standard three-plus-three dose escalation type study with four planned cohorts of single dose and three planned cohorts of multi-dose regimens. We are estimating that approximately 40 subjects will 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 CLR-121225, our broader strategy is to bring first and best-in-class radio therapeutics to market to treat blood cancers and solid tumor with a range of alpha and Auger and beta emitting pay levels. Our Auger 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 enhances targeting allows -- this enhanced targeting allows for the use of isotopes with greater precision, like, the Auger 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 products. 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 iopofosine I 131, 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 both of iopofosine I 131 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 iopofosine 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 iopofosine I 131 as a fully finished ready-to-use product. We currently have two production (ph) 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 iopofosine 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 iopofosine, we are replicating our collaborative outsourcing model with multi-sourcing the production of our development assets like CLR-121225. 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 Auger emitting. 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-131, we are already sourcing actinium from several other suppliers. However, this agreement with Northstar 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. Second, we have demonstrated the ability to complete the iopofosine I 131 technology transfer in a timely and efficient process to multiple such 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.
Jim Caruso: Thank you, Jarrod. As you can see, we remain sharply focused on building value and on the cusp of achieving a series of transformational drugs driving near and long-term growth for Cellectar. We maintain a compelling value proposition with iopofosine I 131 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 minimum existing competitive share of voice, with an expected launch of iopofosine 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 radiotherapeutic 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 Cellectar who are working smart and hard to support iopofosine'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, let's open the call for questions.
Operator: Thank you. Ladies and gentlemen, we will now begin the question-and-answer session. [Operator Instructions] Your first question comes from Jeff Jones with Oppenheimer. Your line is now open.
Jeff Jones: 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 commenced 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?
Jim Caruso: 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 Jarrod to provide more specifics relative to that portion of your question.
Jarrod Longcor: Yeah. So, hi, Jeff. What Jim is referring to is, we have great 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.
Jim Caruso: And then relative to the second part of your question, Jeff, in terms of potential impact on trial use and adoption of iopofosine I 131 commercially. Obviously, we would not anticipate the N for confirmatory study to be significant. And of course, we would, Jarrod, Andrei 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 N regardless of the size, the patients being evaluated ex-U.S. top five, top seven EU, and some of the other sites that participated pretty actively in the CLOVER-WaM study.
Jeff Jones: Okay. 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?
Chad Kolean: So I think that if you look at the time line, 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 will 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.
Jim Caruso: And Jeff, so if you take a look at, if we anticipate, for the sake of palliative care (ph) an April 1 submission, with a 75 day PDUFA, that hits June 15, 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 Jarrod spoke 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 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's market, we view a targeted sales organization with an OpEx in and around this kind of $20 million, $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 more along the lines of a $50 million to $70 million a year expenditure for the effective commercialization. As you recall, not only is the space scalable, there's limited to no multinational pharmaceutical machinery in the space. There's not a lot of spend, share of mind from a thought leadership perspective is highly available for us. And without this share of mind and competitive detailing that you typically see in some of these more highly competitive spaces, a limited investment in commercial medical marketing really yields as high value yielding in terms of increase in trial, use and adoption.
Jeff Jones: Great. Really appreciate the clarity, guys. I’ll hop back into the queue.
Jim Caruso: Thanks so much, Jeff.
Operator: [Operator Instructions] There are no further questions at this time. I will now turn the call over to Jim for closing remarks.
Jim Caruso: Okay. Thank you, operator. Again, thank you for all of you joining us today. And we look forward to keeping you apprised of our progress. Enjoy the day. Thank you.
Operator: Ladies and gentlemen, this concludes your conference call for today. We thank you for participating and ask that you please disconnect your lines.
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