Q3 2024 Cellectar Biosciences Inc Earnings Call
Speaker Change: Ladies and gentlemen, thank you for standing by and welcome at this time.
Speaker Change: 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 PrecisionAQ. Please go ahead.
Thank you, Joelle.
Anne-Marie Fields: Good morning and welcome to Select Our Biosciences third quarter 2024 financial results and business update conference call.
Anne-Marie Fields: 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 Kolean, CFO, for a financial review of the quarter.
Anne-Marie Fields: Following this, Andrei Shustov, Senior Vice President, Medical, will provide an update on the Clover WAM development program. And Shane Lea, Chief Commercial Officer, will review the market opportunity in WAM, along with the company's plans for expected commercial launch.
Anne-Marie Fields: 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.
Speaker Change: Selectar issued a press release earlier this morning detailing the content of today's call. A copy can be found on the investor page of Selectar's corporate website.
Speaker Change: 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.
Speaker Change: 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.
Speaker Change: The content of this conference call contains time-sensitive information that is accurate only as of the date of this live broadcast.
Speaker Change: 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.
Speaker Change: 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 SelectR and an event that we can accurately characterize as transformational for the future of the company.
Jim Caruso: We remain focused on the NDA submission for IFOCUSING I-131 in Walden Strongs and our planned product launch in the second half of 2025.
Jim Caruso: 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.
Jim Caruso: 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.
Jim Caruso: The Clover WAMP study outcomes demonstrating an impressive 56.4% major response rate.
a clinically relevant 80% overall response rate.
Jim Caruso: And 98.2% clinical benefit rate are particularly compelling when you consider that COBR WAMP was conducted in the most heavily pretreated WM patient population ever evaluated in a clinical study.
Jim Caruso: 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.
Jim Caruso: ASH is the healthcare industry's most prestigious hematology congress and provides an exceptional platform to share new data from our WM Pivotal Study.
Jim Caruso: These outcomes will be showcased in a podium presentation by Dr. Sikandar Allawadi, Professor of Medicine.
Jim Caruso: Division of Hematology-Oncology, Departments of Medicine and Cancer Biology at the Mayo Clinic, and the principal investigator for the Clover WAM study.
Speaker Change: With these compelling data in hand, we have engaged the FDA, are constructing our NDA, and remain focused on submitting the application.
Speaker Change: 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.
Speaker Change: 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.
Speaker Change: We will provide additional regulatory pathway clarity in today's prepared statements and as requested in the Q&A session.
Speaker Change: Our sales, marketing, and operation teams continue to construct and execute our commercial plan and will be prepared for the U.S. market launch.
Speaker Change: We have made substantial progress, most recently securing our second Ioproposine I-131 fit and finish manufacturing source, which provides additional production capacity and product supply redundancy at large.
Speaker Change: Long-term, we view expansion of iFocusing i131 to other indolent diplomas as smart, cost-effective, and low-risk investments with the potential to meaningfully increase the overall top-line revenue opportunity.
Speaker Change: Our collaboration with the City of Hope, evaluating iopopazine and mycosis fungoides, is an example of this approach.
Speaker Change: 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.
Speaker Change: continue to aggressively invest in infrastructure necessary to support anticipated growth and demand for novel radiotherapeutics.
Speaker Change: Our pipeline includes preclinically validated phospholipid radiotherapeutic alpha and fulgi 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 IFLS.
Speaker Change: Now, let me turn the call over to Chad Kolean for review of our financials. Chad?
Thank you, Jim, and good morning, everyone.
Chad Kolean: 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.
Chad Kolean: At the time they were issued, these forints of preferred stock were classified as permanent equity, based on our assessment and supported by third-party expert evaluations.
Chad Kolean: 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.
Chad Kolean: 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.
Chad Kolean: Turning to our financial results for the period ended September 30th, 2024, we ended the quarter with cash and cash equivalents of $34.3 million, compared to $9.6 million as of December 31, 2023.
Chad Kolean: Our cash on hand at the end of September includes the funds raised in July 2024 from investor exercises of Tronch B warrants and purchase of new warrants that have the potential to raise up to an additional $73.3 million.
Chad Kolean: All major investors from the September 2023 financing exercised their Transfi warrants at a reduced as converted common stock price of $2.52 per share which was the closing price on the date of exercise.
Chad Kolean: 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.
Chad Kolean: We expect that cash on hand is adequate to fund budgeted operations into the second quarter of 2025.
Chad Kolean: The three warrant tranches issued in July provide additional funding based upon their respective expiration dates.
Chad Kolean: which occur with a first tranche of approximately 17.0 million after we receive a PDUFA date from the FDA.
Chad Kolean: A second tranche of approximately $32.9 million after we received approval via Papacene I-131 from the FDA.
Chad Kolean: And a third tranche of approximately $23.5 million after the first quarter in which we generate $10 million in revenue from Iopophazine I-131.
Chad Kolean: 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.
Speaker Change: The overall increase in R&D was primarily a result of decreased clinical study costs.
Speaker Change: 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.
Speaker Change: 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.
Speaker Change: Net other expenses were approximately $1.4 million in the quarter just ended.
Speaker Change: 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.
Speaker Change: 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.
Speaker Change: 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.
Speaker Change: 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.
Thank you, Chad, and good morning, everyone.
Speaker Change: Our lead acid, Iopophycin I-131, is a small molecule phospholipid radioconjugate, or PRC, designed to provide targeted delivery of iodine-131 directly to cancer cells, while limiting exposure to healthy cells.
Speaker Change: We believe hypothesin has a profile that differentiates it from many traditional on-market and in-development treatments as demonstrated by pivotal study results from global WAMPF.
Speaker Change: Iapophicin 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 Global WM Pivotal Study evaluating Iapophicin I-131 in Waldenstrom's macroglobulinemia.
Speaker Change: Global WHAM is a global, single-arm, Phase IIb study examining Iapophicin 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.
Speaker Change: Patients enrolled in CLOAM 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.
Speaker Change: Based on the demonstrated global WAM study results, we believe iApophicin has the potential to become a first-in-class and best-in-class radiotherapeutic agent to address the high clinical need for elapsed refractory WM patients.
Speaker Change: In October, we were delighted to share these initial compelling results in an oral presentation at the prestigious 12th International Workshop on Waldenstrom's Magnetophagonia, or IWWM.
Speaker Change: WOM experts from around the globe had the opportunity to review and discuss the Global WOM data and provide insights on the future utilization of hypothesis assuming FDA and EMA approvals.
Speaker Change: In addition, an iapopocine 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.
Speaker Change: His review highlighted the complete central nervous system clearance in relapsed refractory bineal syndrome BNS patient treated with Iopophycin I-131.
Speaker Change: BNS is a rare life-threatening complication of WM that manifests in the central nervous system or CNS.
Speaker Change: It typically translates into various neurologic sequelae, such as neuropathy, headaches, visual disturbances, changes in gait, partial paralysis, and is associated with poor outcomes.
Speaker Change: 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.
Speaker Change: Moreover, this response supports the blood-brain barrier, which gives us greater confidence in the potential for similar outcomes in our pediatric high-grade glioma patients.
Speaker Change: As noted earlier, we are honored to have our Global WOM data highlighted in an oral presentation at this year's American Society of Hematology, or ASH, conference, where Dr. Sikandar Allawadi will be presenting the latest study data.
Speaker Change: The ASH presentation provides a tremendous opportunity to share these promising results with the very physicians who care for WM patients in a peer-to-peer discussion forum.
Speaker Change: 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 percent range in a variety of refractory patient populations.
Speaker Change: Iapophicin I-131 has received FDA Fast-Track and Orphan Drug Designation and the European Commission also granted Orphan Drug Designation to Iapophicin for treatment of relapsed refractory MM.
Speaker Change: Building on the hypothesis 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 hypothesis in these cancers may be warranted.
Speaker Change: Mature analysis of the lymphoma cohort from selectors completed phase 2a study will provide guidance
to further refine our reformer franchise strategy.
Speaker Change: 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.
Speaker Change: The collaboration will focus on the clinical development of Iopophycin I-131 and Mycosis Fungoides, the most common subtype of cutaneous T-cell lymphomas and a form of non-Hodgkin lymphoma or NHL.
Speaker Change: MF affects the skin and in some patients internal organs and blood.
Speaker Change: Iopophycin 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.
Speaker Change: This investigative-sponsored trial will evaluate 10 patients and is planned to initiate in early 2025. This is a great opportunity to showcase iapophicin's clinical benefits in yet another hematology oncology indication and a high degree of clinical interest of iapophicin.
And support for this prestigious institution is more than encouraging.
Speaker Change: Finally, a brief mention for our ongoing development in solid tumors, particularly in pediatric high-grade gliomas.
Speaker Change: The phase 1b study of iapophicin in these high-need cancers now has seven clinical sites with patient enrollment ongoing
Speaker Change: This feature maintains the potential to be applicable to a multitude of primary and secondary CNS malignancies.
Speaker Change: With that, I will turn the call over to Shane for the commercial update. 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 WHAM outcomes.
Speaker Change: and including a series of outreach initiatives with KFLs and key community doctors to enhance the visibility for Iapophicine I-131 and Select-R.
Speaker Change: In addition, we will optimize our presence at ASH with an interactive booth on the exhibit floor where conference participants can learn more about Iapopocene I-131, the Clover Web Outcomes, and our novel Platform Science.
Speaker Change: Selecting IAPOFICENE I-131 Pivotal Data as an oral presentation at such an important conference is an efficient opportunity to enhance visibility of IAPOFICENE's novel profile.
Speaker Change: Turning now to the market opportunity for Iopofacin I131 and WM, let's begin with a review of the prevalence of WM.
which in the U.S. is approximately 26,000 patients.
Speaker Change: 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.
Speaker Change: 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.
Speaker Change: Therefore, the total addressable market for third-line or greater therapy is approximately 5,700 patients.
Speaker Change: It's important to note that there are no FDA approved treatment options for patients progressing on BTKI therapy.
Speaker Change: VT-KI therapies do not demonstrate complete response rates and require continuous treatment.
Speaker Change: 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.
Speaker Change: Clearly, there is an established unmet need for new FDA-approved treatments, such as Iopocazine I-131, that could provide a novel mechanism of action, broad responses, and non-continuous treatment, especially in heavily pretreated WM patients.
Speaker Change: We believe Iopofacin 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.
Speaker Change: 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.
Speaker Change: 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.
Speaker Change: Importantly, we believe commercializing iupofazine 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 treating their relapsed refractory WM patients.
Speaker Change: 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.
Speaker Change: IAPOF is seeing strong clinical profile and there being no FDA approved therapies for third line plus treatment.
Speaker Change: provide a clear opportunity to rapidly capture third-line plus patient share.
Speaker Change: The commercial team is continuing to advance on all areas key to launch success including pricing, reimbursement, patient support, distribution, brand positioning, and site activation.
Speaker Change: 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.
Speaker Change: from Market Research that physicians have a high level of interest and favorability rating for Iopophycine's product profile. Let me now turn the call over to Jarrod for an operations update.
Jarrod Longcor: Thank you, Shane, and good morning to everyone. As we think about the regulatory pathway for IPOCUS and I-131, we believe it is important to put our data in context with other approved programs.
Jarrod Longcor: Our major response rates for the CLOVER WAM 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.
Andrei Shustov,
Jarrod Longcor: Ibrutinib's WMNDA 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 naïve. We remain engaged with the FDA and are focused on the tasks required to complete our submission.
Jarrod Longcor: The agency has acknowledged the strength of our data based on recent discussions regarding a potential confirmatory study we shared with the FDA post-full enrollment data cut, which included the primary endpoint and secondary endpoints of the study.
Jarrod Longcor: 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's review timing and requests.
Jarrod Longcor: As a result of this delay and subsequent impact on our submission requirements,
Jarrod Longcor: We are revising our anticipated timeline for NDA submission from late December 2024 to late first quarter or second quarter of 2025.
Jarrod Longcor: As mentioned earlier, the FDA is now recommending a confirmatory study.
Jarrod Longcor: We are in active discussions exploring potential study designs, including a single-arm study like Clover WHAM, which would align with the recommendations from our prime destination discussions with EMA.
Jarrod Longcor: 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.
Jarrod Longcor: We understand how important this program is to patients, our partners, and stockholders, and we are taking all possible steps to accelerate our timelines.
Jarrod Longcor: 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.
Jarrod Longcor: Despite this delay of approximately one quarter, we believe the long-term success of EyeFocusing and SelectR remains unchanged, and we are committed to the rapid submission and subsequent launch of EyeFocusing.
Jarrod Longcor: Next steps are to conduct a November meeting with the FDA and reach agreement on any potential confirmatory study and submission timing.
Jarrod Longcor: 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.
Jarrod Longcor: We are now observing a shift to product, asset, or platform acquisitions.
Speaker Change: Selecta remains one of the few companies with a large-stage or late-stage targeted radiotherapy with a validated delivery platform. As a result, we remain active in the evaluation of potential partnership structures.
Speaker Change: 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.
Speaker Change: 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 Iopobicin 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 possible lipid drug conjugates.
Speaker Change: The second phase is to expand our pipeline of targeted radiotherapy, both with line extensions of Iopopacin and the advancement of other isotopes such as our Alpha Emitter and Ogee Emitter programs.
Speaker Change: Beyond Ipocazine, we are excited with the progress we've made with our PRC franchise of alpha and OG emitting radioconjugate programs. Our novel targeted alpha therapy compounds include Actinian by-product candidate known as CLR121225.
Speaker Change: which has demonstrated promising therapeutic potential in several solid tumors, including pancreatic cancer, typical negative breast cancer, and ovarian cancer, justifying clinical development for these indications.
Speaker Change: Our PRC platform has the capacity to deliver any alpha emitter and we have already tested several others including lead 212 and acetylene 211 allowing us to optimize radioisotope selection and delivery based on specific tumor biology.
Speaker Change: Said another way, we can target the right isotope for the right tumor.
Speaker Change: We plan to initiate our Phase I study with CLR 121, 225 in 2025.
Speaker Change: The Phase 1 trial will include an initial dosimetry component and then be a standard 3 plus 3 dose escalation study with 4 planned cohorts of single dose and 3 planned cohorts of multi-dose regimens.
Speaker Change: We are estimating that approximately 40 subjects will be enrolled with safety as the primary endpoint and secondary endpoint to 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.
Speaker Change: 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 pay levels. Our OG program has also demonstrated excellent activity in preclinical models of solid tumors.
Speaker Change: 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.
Speaker Change: Turning now to our supply chain, manufacturing targeted radiotherapies is both operationally and technically complex.
Speaker Change: 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.
Speaker Change: 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.
Speaker Change: As discussed previously, for Iopoccine I-131, which utilizes iodine-131, we have relationships with and validated three separate suppliers and continue to assess additional suppliers.
Speaker Change: Our current partners provide redundancy in the isotope supply to allow scalable production of Iopopacin I-131 either weekly or multiple times a week.
Speaker Change: Similar to the isotope sourcing strategy, we validated and secured our targeting ligand, or PLE, sourcing from multiple contractors.
Speaker Change: Currently, a single batch produces enough PLE to produce 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.
Speaker Change: Importantly, we are also multi-sourcing Ipoxen 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.
Speaker Change: Last week, we were delighted to announce a long-term commercial supply agreement with Spectron RX for the manufacturer of Ipopoxine I-131. This collaboration expands our U.S. business relationship with Spectron RX and anticipates the utilization of Spectron's planned facility in Europe.
Speaker Change: As achieved with iFocusene, we are replicating our collaborative outsourcing model with multisourcing the production of our development assets like CLR 121, 225.
Speaker Change: 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 admitting.
Speaker Change: 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.
Speaker Change: As with Iodine I-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 with additional producers of actinium-225 as the program successfully continues.
Advances.
Speaker Change: In addition to sourcing our finished product requirements, our outsourcing model provides additional benefits.
Speaker Change: One, we have significantly reduced the capital expenditure and future maintenance costs associated with an internal manufacturing capacity.
Speaker Change: Second, we have demonstrated the ability to complete the IOPOC 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.
Jim Caruso: 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 goals, driving near and long-term growth for SelectR.
Jim Caruso: We maintain a compelling value proposition with Ioptriloxene I-131, with solid clinical data and a differentiated product profile to support its potential accelerated approval in WM.
Jim Caruso: The disease with great unmet need, limited approved treatment options, and a significant revenue opportunity.
We are preparing for a successful WM product launch.
Jim Caruso: for a highly scalable market, presenting minimum existing competitive share of voice with an expected launch by a focus for the end of 2020.
Jim Caruso: And we possess a unique PLE-based delivery platform which provides drug development optionality.
Jim Caruso: 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.
Jim Caruso: 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.
Jim Caruso: I want to take a moment to thank the dedicated and talented team here at SelectArt who are working smart and hard to support Iopopracine's marketing approval and projected launch while advancing our promising pipeline of radiopharmaceuticals.
Jim Caruso: 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.
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 one on your touchtone phone. You will hear a prompt that your hand has been raised.
Speaker Change: Should you wish to decline from the polling process, please press star followed by the 2.
Speaker Change: If you are using a speakerphone, please lift the handset before pressing any keys.
One moment, please, for your first question.
Speaker Change: Your first question comes from Jeff Jones with Oppenheimer. Your line is now open.
Andrei Shustov,
Good morning, guys, and congrats on the quarter.
Speaker Change: In addition, as we think about confirmatory studies going on during launch, how do you think that impacts product uptake and adoption?
Speaker Change: confirmatory study prior to our capacity to submit the application. We don't believe that's the case based on 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 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.
Thank you for watching!
Jarrod Longcor: And then, relative to the second part of your question, Jeff, in terms of potential impact on, you know, trial use and adoption of Iopopacin I-131 commercially, obviously, we would not anticipate the end for a confirmatory study to be significant, and, of course, we would...
Jarrod, Andrei, and the team.
would align with the EMA.
Jarrod Longcor: 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, be patients being evaluated, XUS, top five, top seven, EU, and some of the other sites that participated, you know, pretty actively in the Clover WHAM study.
Thank you for watching!
Andrei Shustov,
Speaker Change: 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?
Thank you very much.
Speaker Change: 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
Speaker Change: would not really fall into the timing for exercise until, you know, 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.
Speaker Change: And Jeff, so if you take a look at, if we anticipate for the sake of palliative care, an April 1 submission,
Speaker Change: on the evaluation of some of the corporate development activities that we're currently evaluating and are ongoing that Jarrod 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.
Speaker Change: You know, we'll 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.
Speaker Change: with an OPEX and in and around this kind of $20, $25 million a year range as being more than sufficient.
for the effect of commercialization.
Speaker Change: As you recall, not only is this space scalable, there's limited to no multinational pharmaceutical machinery in this space. There's not a lot of spend. Shearer Mind, from a thought leadership perspective, is highly available for us.
Speaker Change: 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 as high value yielding in terms of increase of trial use of adoption.
Speaker Change: Really appreciate the clarity guys. I'll hop back into the queue
All right. Thanks much, Jeff.
Speaker Change: Ladies and gentlemen, as a reminder, should you have a question, please press star 1.
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Speaker Change: There are no further questions at this time. I will now turn the call over to Jim for closing remarks.
Andrei Shustov,
Jim Caruso: 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
Speaker Change: 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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