Cellectar Biosciences Q3 2024 Earnings Call Transcript

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November 18, 2024

There are 6 speakers on the call.

Operator

Ladies and gentlemen, thank you for standing by, and welcome at this time. All participants are in a 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 of Precision AQ.

Operator

Please go ahead.

Speaker 1

Thank you, Joelle. Good morning, and welcome to Selectar Biosciences' Q3 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 Collian, CFO, for a financial review of the quarter. Following this, Andrey Shustoff, Senior Vice President, Medical, will provide an update on the Clover WAM development program and Shane Leah, Chief Commercial Officer, will review the market opportunity in WM along with the company's plans for expected commercial launch. Finally, Jared Longkar, Chief Operating Officer, will give an update on the company's progress and plans for its promising clinical development pipeline of radiopharmaceuticals.

Speaker 1

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. 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.

Speaker 1

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.

Speaker 1

With that, let me turn the call over to Jim Caruso. Jim?

Speaker 2

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 IFROCICINI-1 hundred and thirty one in WALP and STRONDS and our planned product launch in the second half of twenty twenty five. 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.

Speaker 2

The cloverwam 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 COBRA 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 Doctor. Sukanta Alawadi, 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.

Speaker 2

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 Q1 of 2025 and potentially into Q2. That said, given our accelerated approval designation, which provides review and determination within approximately 6 months of filing, we maintain our timeline for potential market approval and the launch in the second half of twenty twenty five. We will provide additional regulatory pathway clarity in today's prepared statements and as requested in the Q and A session. Our sales, marketing and operation teams continue to construct and execute our commercial plan and will be prepared for the U.

Speaker 2

S. Market launch. We have made substantial progress, most recently securing our 2nd iofofacin I-one hundred and thirty one fit and finish manufacturing source, which provides additional production iFocusing I-one hundred and thirty one 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 iapofacin 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 continue to aggressively invest in infrastructure necessary to support anticipated growth in demand for novel radiotherapeutics.

Speaker 2

Our pipeline includes pre clinically validated phospholipid radiotherapeutic alpha and FOSHI 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 a review of our financials. Chad?

Speaker 3

Thank you, Jim, and good morning, everyone. Recently, we filed amended financial statements for fiscal years 2023 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 3rd 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 and D expenses to G and A.

Speaker 3

Turning to our financial results for the period ended September 30, 2024, we ended the quarter with cash and cash equivalents of $34,300,000 compared to $9,600,000 as of December 31, that have the potential to raise up to an additional 73.3 that have the potential to raise up to an additional $73,300,000 All major investors from the September 2023 financing exercised 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 19,400,000 after customary fees and expenses of $17,500,000 We expect that cash on hand is adequate to fund budgeted operations into the Q2 of 2025. The 3 warrant tranches issued in July provide additional funding based upon their respective expiration dates, which occur with the first tranche of approximately $17,000,000 after we receive a PDUFA date from the FDA. A second tranche of approximately $32,900,000 after we receive approval of iapopecine I-one hundred and thirty one from the FDA. And a third tranche of approximately $23,500,000 after the Q1 in which we generate $10,000,000 in revenue from IAPOPISI and I-one hundred and thirty one.

Speaker 3

Research and development expenses for the 3 months ended September 30, 2024 were approximately $5,500,000 compared to approximately $7,000,000 for the 3 months ended September 30, 2023. The overall increase in R and 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 3 months ended September 30, 2024 were $7,800,000 compared to $2,400,000 for the same period in 2023. The increase in G and 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 $1,400,000 in the quarter just ended, while they were approximately $8,100,000 in the same period last year.

Speaker 3

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 300,000 dollars from $100,000 previously. Net loss for the period ended September 30, 2024 was $14,700,000 or $0.37 per basic share and $0.40 per fully diluted share, compared with $17,500,000 or $1.55 per basic and fully diluted share during the same period in 2023. I will now turn the call over to Doctor. Shustoff.

Speaker 2

Thank you, Chad, and good morning, everyone. Our lead acid, iapofacin I-one hundred and thirty one is a small molecule phospholipid radior conjugate or PRC, designed to provide targeted delivery of iodine-one hundred and thirty one directly to cancer cells while limiting exposure to healthy cells. We believe iPOPHECIN has a profile that differentiates it from many traditional on market and in development treatments as demonstrated by the pivotal study results from CLOVA WAM. Iapofacin 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 ipofersen I-one hundred and thirty one in Waldenstrom's macroglobulinemia.

Speaker 2

GLOBALAM is a global single arm Phase 2b study examining Ibofersen I-one hundred and thirty one in relapsed and refractory WM patients who received at least 2 prior lines of therapy including those patients who fail or had suboptimal response to BTKI, the only FDA approved class of treatment for this cancer. Patients enrolled in FLOWAM 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 iapofacin has the potential to become 1st in class and best in class radiotherapeutic agent to address the high clinical need for relapsedrefractory 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 macrophagulinemia or IWWM.

Speaker 2

WM experts from around the globe had the opportunity to review and discuss the CLO-1M data and provide insights on the future utilization of iapofacin assuming FDA and EMA approvals. In addition, an iapofacin case study report was presented by Jorge Castillo, MD, Associate Professor of Medicine, Harvard Medical School and Clinical Director, Ping Center for Waldenstrom's macroglobulinemia at the Dana Farber Cancer Institute. His review highlighted the complete central nervous system clearance in relapsedrefractory Ben Neils syndrome BNS patient treated with hypophecy in I-one hundred and thirty one. 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.

Speaker 2

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 1st 3 years of the diagnosis. Moreover, this response supports iapofersen I-1 hundred and thirty one 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 CLOVOEM data highlighted in an oral presentation at this year's American Society of Hematology or ASH Conference where Doctor. Sikanda Allawadi 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 forum.

Speaker 2

Beyond the clinical success with iapofacin and WM, we have compiled a rich data set in relapsedrefractorymultiple myeloma with response rates in the 30% to 60% range in a variety of refractory patient populations. Ibuprofen I-one hundred and thirty one has received FDA Fast Track and orphan drug designation and the European Commission also granted orphan drug designation to Ibuprofen for treatment of relapsed refractory Building on the Ibuprofen's exciting clinical results, known radio sensitivity of the related lymphoid malignancies as well as established legacy of beta emitting radioisotopes, iodine I-one hundred and thirty one in particular in indolent and aggressive lymphomas, further clinical development of hypofersen in these cancers may be warranted. Mature analysis of the lymphoma cohort from CELACTO'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.

Speaker 2

The collaboration will focus on the clinical development of iapofacin I-one hundred and thirty one in mycosis fungoides, the most common subtype of cutaneous T cell lymphomas and the form of non Hodgkin lymphoma or NHL. MF affects the skin and in some patients internal organs and blood. Hypofersen is the 1st 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 iapofacin's clinical benefits in yet another hematology oncology indication and a high degree of clinical interest of iapofacin.

Speaker 2

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 iapofacin in this high need cancers now has 7 clinical sites with patient enrollment ongoing. Observing activity in pediatric brain cancers provides further evidence of the ability of iapofacin 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.

Speaker 2

With that, I will turn the call over to Shane for the commercial update.

Speaker 3

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 CLOVER WAM outcomes and including a series of outreach initiatives with KOLs and key community doctors to enhance the visibility for Ibuprofen I-one hundred and thirty one and select our. In addition, we will optimize our presence at ASH with an interactive booth on the exhibit floor where conference participants can learn more about Ibuprofen I-one hundred and thirty one, the CLOVER WAM outcomes and our novel platform science. Selecting iapofacine I-1 hundred and thirty one pivotal data as an oral presentation at such an important conference is an efficient opportunity to enhance visibility of iapofacine's novel profile. Turning now to the market opportunity for iapofacine I-one hundred and thirty one and WM, let's begin with a review of the prevalence of WM, which in the U.

Speaker 3

S. Is approximately 26,000 patients with 1500 to 1900 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 3rd line because of progression, ineligibility or intolerance to those existing therapies. Therefore, the total addressable market for 3rd line or greater therapy is approximately 5,700 patients.

Speaker 3

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 iapofacin I-1 hundred and thirty one that could provide a novel mechanism of action, broad responses and non continuous treatment, especially in heavily pretreated WM patients.

Speaker 3

We believe Ibupofacin I-one hundred and thirty one assuming an FDA approval can be the new standard of care for 3rd 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 Ibupofacin 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 3

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. Ibuprofen's strong clinical profile and there being no FDA approved therapies for 3rd line plus treatment provide a clear opportunity to rapidly capture 3rd 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 iapofacine's product profile.

Speaker 3

Let me now turn the call over to Jared for an operations update. Jared?

Speaker 4

Thank you, Shane, and good morning to everyone. As we think about the regulatory pathway for iFocus9-1 hundred and thirty one, we believe it is important to put our data in context with other approved programs. 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 4 prior lines, highly refractory and over 70% post BTKI. Ibrutinib's WMNDA submission had a 61.9% major response rate in an earlier line of treatment where patients had 2 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 task required to complete our submission.

Speaker 4

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. The goal was to provide the FDA a comprehensive overview of results and supporting data to facilitate a discussion on next steps considering iapofencing 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. Selectar has maintained internal submission timelines. However, we must remain flexible with the FDA, FDA's review timing and request.

Speaker 4

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 Q1 or Q2 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 destination 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 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.

Speaker 4

Despite this delay approximately 1 quarter, we believe the long term success of iapocin and Selecta remains unchanged and we are committed to the rapid submission and subsequent launch of iapocin. Next 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.

Speaker 4

Selecta remains one of the few selectar remains one of the few companies with a

Speaker 2

large stage or late stage targeted

Speaker 4

radiotherapy with a validated delivery platform. As a result, 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 3 phases.

Speaker 4

The initial phase brings iFocus and I-1 hundred and thirty one 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 iapopacine and the advancement of other isotopes such as our alpha emitter and o gee emitter programs. Phase 3 advances new verticals such as small molecule cytotoxins, oligonucleotides and peptide tailings. Beyond iFocusing, we are excited with the progress we've made with our PRC franchise of alpha and OG emitting radio conjugate programs.

Speaker 4

Our novel targeted alpha therapy compounds include actinium 5 product candidate known as CLR112 1225, 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 LAD-two twelve and acetamin-two eleven, 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-twelve twelve 25 in 2025. The Phase I 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 4

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 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.

Speaker 4

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 IAPOCI and I-1 hundred and thirty one, which utilizes iodine-one hundred and one.

Speaker 4

We have relationships with and validated 3 separate suppliers and continue to assess additional suppliers. Our current partners provide redundancy in the isotope supply to allow scalable production both of iapopacine I-one hundred and thirty one 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 I-focusing I-one hundred and thirty one at maximum forecasted sales volumes with additional capacity to support at least one other program for greater than 3 years. We maintain the capacity to increase PLE supply as needed.

Speaker 4

Importantly, we are also multi sourcing iFocus 9131 as a fully finished ready to use product. We currently have 2 perception 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 supply agreement with SpectronRx for the manufacture of iofocusing I-one hundred and thirty one. This collaboration expands our U. S.

Speaker 4

Business relationship with SpectronRx and anticipates the utilization of Spectron's planned facility in Europe. As achieved with iFOCICINE, we are replicating our collaborative outsourcing model with multi sourcing the production of our development assets like CLR-one hundred and twenty one-two twenty five. 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 whether they are alpha, beta or OJ 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 add in, Actinium-two twenty five, into our proprietary PLE delivery platform.

Speaker 4

As with IDEN I-one hundred and thirty one, we are already sourcing Actinium from several other suppliers. However, this agreement with Northstar provides a reliable and reproducible source of Actinium-two twenty five. It is our plan to contract additional producers of Actinium-two twenty five 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.

Speaker 4

2nd, we have demonstrated the ability to complete the iFocus and I-1 hundred and thirty one 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.

Speaker 2

Thank you, Jared. As you can see, we remain sharply focused on building value and on the cusp of achieving a series of transformational wins, driving near and long term growth for Selector. We maintain a compelling value proposition with iapruvacine I-1 hundred and thirty one 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 via focusing toward the end of 25. And we possess a unique PLE based delivery platform, which provides drug development optionality and currently maintain the option to advance 2 unique radiotherapy assets into the clinic for the treatment of large market solid tumors as company and market dynamics dictate.

Speaker 2

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 SelectArt who are working smart and hard to support iapopacine'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

Operator

Thank you. Ladies and gentlemen, we will now begin the question and answer session. Your first question comes from Jeff Jones with Oppenheimer. Your line is now open.

Speaker 5

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?

Speaker 2

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.

Speaker 4

Yes. So, hi, Tim. What Jim is 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.

Speaker 2

And then relative to the second part of your question, Jeff, in terms of potential impact on trial use and adoption of iofocusing I-1 hundred and thirty one commercially, obviously, we would not anticipate the end for a confirmatory study to be significant. And of course, we would, 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 BN regardless of the size, the patients being evaluated ex U. S, top 5, top 7 EU and some of the other sites that participated pretty actively in the CLOVER WAM study.

Speaker 5

Okay, great. And I guess just one financial question for you guys. You gave cash runway guidance. Assuming the full exercise of the $73,000,000 worth of outstanding warrants, Where does that take you roughly as you prepare for launch?

Speaker 3

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 could 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.

Speaker 2

And Jeff, so if you take a look at if we anticipate for the sake of palliative care 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 alluded 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 $73,000,000 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 market, we view a targeted sales organization with an OpEx in and around this kind of $20,000,000 $25,000,000 a year range as being more than sufficient to drive trial use and adoption.

Speaker 2

And that I think is important to note because typically in oncology spaces, you're looking at more along the lines of a $50,000,000 to $70,000,000 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 this 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.

Speaker 2

A limited investment in commercial medical marketing really yields as high value yielding in terms of increased trial use of adoption.

Speaker 5

Great. Really appreciate the clarity guys. I'll hop back into the queue.

Speaker 2

All right. Thanks so much, Jeff.

Operator

There are no further questions at this time. I will now turn the call over to Jim for closing remarks.

Speaker 2

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.

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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