Cellectar Biosciences, Inc. Price & Performance (CLRB)

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 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's accurate only as of the date of this live broadcast. 03/13/2025. The company undertakes 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. [indiscernible] begin the call with prepared remarks and then open the lines for your questions. I'll now turn the call over to Jim Caruso. Jim?

Thank you, Anne Marie. And thank you to all for joining us this morning as we share Cellectar our ongoing preparations to advance our alpha and OG radioisotope solid tumor programs and forward looking plans to address the company's NASDAQ status and future funding including evaluation of non funding opportunities. 2024 can be described as a very sweet year for SelectArc starting with the announcement of excellent clinical results, from our Clover WAN study of iapocin I-one hundred and thirty one for the treatment of relapsedrefractory Waldenstrom's macroglobulinemia or WN. And concluding with disappointing regulatory news which delays the submission of the new drug application or NDA for conditional approval under the accelerated approval process. In the CLOVER WAM study, iapobacine demonstrated an impressive ninety eight point two percent clinical benefit rate eighty three point six percent overall response rate and a major response rate of fifty eight point two percent. These clinical outcomes are particularly meaningful for this challenging to treat relapsed refractory elderly patient population. For these patients, limited reduction in tumor burden or achievement of disease stability can provide clinical benefit with improved symptoms and extended progression free survival and time to next treatment. We remain confident in the potential value I am focusing will provide patients suffering from this incurable disease.

Unfortunately, we experienced a regulatory setback with our plans to file an NDA in the first half of twenty twenty five. Which adversely impacted our stock price toward the end of last year. As the clinical data demonstrates, ipoposin offers potential to be a meaningful treatment for all relapsed refractory WM patients. As such and aligned with the FDA, we recrafted the path to market through the accelerated approval process. Pathway. Our comprehensive product market research market sizing and commercial analysis underscores IOPOSING's significant market potential at the relaxed refractory setting. This potential is driven by iopofacin novel mechanism of action its distinctive product profile [indiscernible] Mark? In addition to clinical benefits and the product profile, other key attributes include a fixed dosing regimen, a unique seventeen day shelf life orphan drug pricing and its ability to address a high unmet clinical need in a landscape with limited approved treatment options. These factors collectively position our focusing as a promising therapeutic candidate in this challenging market segment and Cellectar remains committed to bringing this potentially life saving drug to patients. Likely to benefit from this treatment. 2% we recently held a very productive meeting with the FDA to finalize the regulatory pathway for I ampicin in WN.

I am pleased to share that we have achieved alignment on the design of a Phase three study required for market approval. Later in this call, Jared will discuss the study design, the cost efficiency and projected timelines to advance iopovacene toward commercialization. Given the strong enthusiasm surrounding IOP focusing among patients, key opinion leaders in WN, and the broader healthcare community. We are confident that the study will achieve rapid enrollment. This momentum underscores the high level of interest and I am focusing as a potential therapy for this challenging disease. And reflects its significant promise in addressing unmet clinical needs. Based upon the quality of the CloverWAM data, limited perceived clinical risk to approval and a robust global market opportunity, we continue to evaluate inbound inquiries regarding a range of collaborations and licensing deals, which is our preferred non dilutive one coverage. In addition to our late stage iofocin program in WN, we remain bullish on our solid tumor focused radioisotope programs which include our alpha emitter for pancreatic cancer, and the OG Emitter for evaluation in triple negative breast cancer. Both of which highlight the novel utility of our delivery platform. As mentioned earlier, the delay in our NDA submission for iopopacin adversely impacted the company's stock and market capitalization.

We believe we can organically increase our stock price to satisfy the NASDAQ requirement based upon driving milestones such as regulatory clarity for iopopacin WN, acquisition of non dilutive funding, technology validation through third party collaborations and progress with our Phase one ready radioisotope assets. Along the removal of any perceived financial overhead. Now let me turn the call over to Chad for additional color on this topic and a detailed review of our financial results. Chad? Thank you, Jim.

I In 2024, we executed multiple financial transactions that strengthened Cellectar balance sheet. Including investors' exercise of warrants in January, generating $44,100,000 dollars dollars and an inducement financing in July, which included the exercise of existing warrants and the purchase of new warrants were $19,400,000 in pro As we communicated last October, we filed our historical financial statements for fiscal years 2023 and 2022. An action that was precipitated by a reevaluation of the accounting for warrants issued prior to 2023. [indiscernible] As a reminder, at the time of issuance, the warrants were classified as equity based. Upon internal and external assessment. As supported by our existing accounting firm at that time, [indiscernible] and a global professional services firm, which provided an expert third party evaluation. A subsequent internal review determined that these warrants should have been classified as liabilities, which necessitated the revision to our historical reporting. Importantly, the restatement had no impact on historical cash or cash burn as reported and the changes to earnings were all non operating. And non cash. Now turning to our financial results in the fourth quarter full year ended 12/31/2024. We ended the year with cash and cash equivalents of 23,300,000.0 as compared to 9,600,000.0 as of 12/31/2023. [indiscernible] Based upon the delay in IOPOPHYMS NDA submission and lack of regulatory clarity, we implemented a cost saving strategic restructuring which reduced headcount by approximately 6% We expect restructuring to drive savings of approximately $7,500,000 annually and to extend our cash runway into the fourth quarter of twenty twenty five.

Moving to the operating results. Research and development expenses for the full year 2024 approximately $26,100,000 compared with $27,300,000 in the prior year. The decrease was largely driven by the timing of expenditures for our WMO Phase two study to support patient enrollment and follow-up visits, and was partially offset by the extensive analytics work necessary to prepare for a plan NDA submission product sourcing and expansion of manufacturing and logistics infrastructure costs to support multi sourcing each aspect of IOPO Selling, general and administrative expenses for the full year 2024 were 25,600,000.0 compared to $11,700,000 in the prior year. These incremental investments were largely due to pre commercialization initiatives such as product related qualitative and quantitative market research, market sizing, competitive landscape, product pricing research, patient support programming third party payer work, wholesaler distribution and channel development. This research and analytical work product further validated the enhancing the value of iapofibin and supporting our funding efforts and potential collaborations. With prospective partners. Other income and expense net was approximately $7,400,000 of income in 2024 as compared to approximately $3,900,000 of expense in the prior year.

These amounts are almost exclusively non cash and are driven by the issuance and valuation of equity securities. In conjunction with our financing activities. The only component of this category impact cash is interest income.

Which for the year just ended improved to approximately $1,200,000 from $400,000 in 2023. [indiscernible] Net loss for the full year ended 12/31/2024, was $44,600,000 or $1.22 per basic share, $1.4 per fully diluted share.

Compared to $42,800,000 or $3.5 per basic and fully diluted share during 2023. Addressing our compliance with the continued listing requirements for NASDAQ, As Jim noted in his opening remarks, we are engaged on a broad variety of fronts to further strengthen the balance sheet and enhance the valuation of the company. NASDAQ provides an additional 100 an initial one hundred and eighty day remediation period [indiscernible] NASDAQ also maintains the right grant an additional one hundred and eighty ks remediation period upon request. Provided the company meets all other listed criteria. If necessary, we will request an additional one hundred and eighty day remediation. Period.

In addition, to create corporate optionality, we will ask our stockholders to approve a possible reverse stock split as part of our June twenty twenty five Annual Meeting. [indiscernible] Of course, a reverse split would only be implemented if all other initiatives have been exhausted and it is deemed absolutely necessary to do so. We believe this multifaceted approach enables the company's ability to maintain optionality and deliver the best available outcome for all constituencies. I will now turn this call over to Jared for an operational update, including plans for our promising pipeline of radiopharmaceuticals. Thank you, Chad, and good morning, everyone.

I will begin by providing a regulatory update on iapobacine for the treatment of WN. Following our November 2024 FDA meeting, we sought to obtain additional clarity on the agency's preferred study design to support an accelerated approval. We formally submitted an end of Phase two meeting request in early January providing a study protocol designed to align with the FDA's clinical development feedback. The formal meeting was held on March 6 and I am pleased to report that we successfully achieved a crucial milestone for the future development of bioporphine I-one hundred and thirty one. Establishing a clear regulatory pathway for our promising drug. We view the outcome as a significant win and believe it sets a clear path to the NDA submission and market approval for iapocin in WM patients. The path requires the completion of a confirmatory randomized controlled study vibopoxone I-one hundred and thirty one We versus a comparator arm, which will provide the study investigators a choice between one of two NCCN approved treatment options.

This trial is expected to enroll approximately 100 patients per arm, Both the FDA and Cellectar have agreed upon the major protocol elements and the requirements for accelerated and full approval. The approval process is anticipated to proceed in two stages, The conditional accelerated approval is based upon major response rate, Subsequently, full approval is contingent upon achieving progression free survival and We anticipate that the study to enroll will enroll rapidly and to achieve full enrollment within approximately twenty four months of the first patient treated. The total cost is between $40,000,000 and $45,000,000 We estimate that approximately $30,000,000 will be required to achieve full enrollment facilitates the NDA submission for conditional approval. The approximately $15,000,000 remaining will be required for the termination of PFS, long term follow-up and study closure. This approach aligns with FDA guidance and provides a well defined path to potentially bring ipoxynin-one hundred and thirty one to market. For the treatment of relapsedrefractory WM patients in The U. S. We are also seeking to reach similar alignment with the EMA Or Your Medical Agency To Harmonize The Study Design For Market Approval In Both The U. S. And Europe.

We expect to be ready to initiate this study later this year. In addition to these activities, Cellectar is in tumor targeting delivery platform to develop unique potentially game changing cancer treatments. Our PDCs possess the potential to deliver improved efficacy and better safety resulting from improved targeting of various oncology payloads to the tumor. Iapobacine clearly provides clinical proof of concept for the platform with the targeted delivery of a radioisotope. Based upon this validation, we have developed a broad proprietary pipeline that includes other targeted radioisotopes small molecules, peptides and oligonucleotides, each of which has been validated in vitro and in vivo. The modular nature of the platform has allowed us to rapidly and iteratively test and evaluate most therapeutic radioisotopes across the different classes of emitter types. Provides the unique ability to more effectively select the right isotope for the right tumor. We accomplished this by taking advantage of our near uniform targeted delivery to allow for the rapid and simultaneous testing of various isotopes in the same in vivo models. Our approach results in a comparative assessment of the tolerability and activity of each isotope in each type of cancer. [indiscernible] While most radioisotope development companies focus on varying the targeting element to improve activity. [indiscernible] This does not account for the impact of the isotope selection.

Our technology allows the optimization of both essential elements and has demonstrated in vivo differential benefit between isotopes for specific tumor types. I will now review two of our exciting early stage radio conjugates, The first is our alpha emitting actinium based compound COR-one 21 We and the second is CLR121225 our lead OJE emitter. CLR-one 21,225, is our lead alpha conjugate product candidate that has shown excellent bio distribution and uptake in the tumors. Exhibiting activity across multiple solid tumor animal models, including pancreatic ductal adenocarcinoma and colorectal cancers. Importantly, in all tumor types tested, CLR 121,225, has been shown to be safe and well tolerated. Like iapobacine, we have established a network isotope and finished product CDMOs to guarantee sufficient supply in the near and long term for the full development of CLR-one hundred and one thousand two hundred and twenty five.

We continue to evaluate additional CDMOs to ensure capacity for indication expansion and long term risk mitigation. The Phase one trial for SINGULAR-one hundred and twenty one two hundred and twenty five is designed to be comprehensively evaluate [indiscernible] safety and tolerability in patients with pancreatic adenocarcinoma. The study will commence with a dosimetry phase aimed at determining the absorbed dose in both normal and tumor tissue This initial assessment will provide valuable insights into the compound's distribution and potential therapeutic window laying the foundation for subsequent phases of the trial and future development. [indiscernible] Following dosimetry, the study will progress to a dose escalation phase systematically evaluating increasing doses of COR-one hundred and twenty one thousand two hundred and twenty five to establish the maximum tolerated dose. This carefully structured approach offers an opportunity to demonstrate proof of concept of our innovative combination of phospholipid ether or PLE technology with alpha emitters. Potentially showcasing this radio conjugates unique ability to safely treat large, bulky, solid tumors. The significance of this trial extends beyond its immediate objective Positive outcomes in this notoriously challenging tumor type could represent a paradigm shift in cancer treatment approaches. We believe that valuable data from this study could be transformative for Cellectar potentially opening new avenues for targeted radiotherapeutics and rapidly advancing our position to forefront of cancer treatment innovation.

We will be prepared to initiate this study in the first half of twenty twenty five. OJ emitting isotopes represent the pinnacle of precision in targeted radiotherapy. With emissions traveling only a few nanometers, this ultra short range necessitates delivery of the isotopes in close proximity to the cellular DNA to achieve therapeutic activity. Our proprietary PDC platform uniquely enables intracellular delivery and facilitates the necessary targeted delivery at the subcellular level setting CLR-one 21,125 apart the landscape of radiopharmaceuticals and potentially offering a new paradigm in targeted cancer therapy. [indiscernible] are strategically positioned to advance CLL-one hundred and twenty one twenty five, our lead OJ emitter using iodine-one 25 as radio conjugate product [indiscernible] into the next stage of development. The activity of COR-one 20 one-one 20 five's intracellular delivery mechanism has been rigorously validated through preclinical studies These investigations have demonstrated significant tumor uptake across multiple animal models resulting in promising activity and tolerability profiles even in notoriously challenging tumor types such as triple negative breast cancer and metastatic breast cancer. Similar to CLR-one 21,225, we are preparing CLLR-one 21,125 for a Phase Ib study in triple negative breast cancer. This trial will evaluate three distinct doses and dosing regimens with the primary objective of identifying the optimal recommended Phase two dose.

The study will include an imaging component to further elucidate the biodistribution of CLR-one hundred and twenty one one hundred and twenty five providing crucial insights into its targeting and potential efficacy. By focusing on triple negative breast cancer, we are targeting an aggressive and difficult to treat subtype of breast cancer underscoring our commitment to addressing high unmet medical needs. The strategic decision to pursue this indication aligns with our broader mission to develop innovative therapies for challenging delinquencies.

Success in this area could be particularly impactful given the limited treatment options currently available for triple negative breast cancer patients. [indiscernible] We anticipate the positive data from this study could significantly enhance the value proposition of CLR-one hundred and twenty one one hundred and twenty five and by extension our entire radiopharmaceutical platform. [indiscernible] These trials represent a critical step in our pipeline development potentially positioning both 21,225 and CLR-one hundred and twenty one thousand one hundred and twenty five as groundbreaking therapies in the evolving landscape of targeted radiopharmaceuticals for cancer treatment. [indiscernible] Furthermore, these programs showcase the versatility of our platform and reinforces our commitment about developing innovative highly targeted treatments that could significantly improve outcomes for patients. With that, let me turn the call back to Jim for closing remarks. Jim? Thank you, Terry. As you can see, are off to a very good start in 2025 by rapidly securing clarity on the FDA's requirements for a conditional approval under the accelerated approval pathway. To state the obvious, this is a significant achievement and asset value enhancer. As I previously reported, we are in a advanced discussions with multiple companies regarding the licensing rights for iofocus.

Regulatory strategy established the FDA provides a clear and cost efficient regulatory pathway forward for I am focusing with what we believe to be limited clinical and execution risk. In essence, the regulatory clarity has significantly enhanced the value of IFRS 16. Non dilutive cash associated with these potential deals would be highly beneficial for the company.

In addition, we will be prepared to initiate Phase one studies for both the alpha [indiscernible] and pancreatic cancer and the OG emitter for triple negative breast cancer in the first half of twenty twenty five. The initiation of these respective studies are to be determined. Our current cash position extends into the fourth quarter to evaluate and advance non dilutive licensing deals and potential funding vehicles and in parallel assess timing for the initiation of our Phase one assets. Before opening the call to your questions, I would like to thank our dedicated and talented Cellectar team who continue to work with tremendous determination to move these important programs and the company forward. We remain committed to the WM community and sincerely appreciate the abundance of support and continued encouragement to advance iopofasim to market. Together, we continue to push the boundaries of what is possible in oncology, and we look forward to the future with optimism and goals. Operator, we are ready to open the call to questions.

Our first question comes from the line of Jeff Jones from Oppenheimer. Your line is open. Hi. Thanks for the update. This is Faiz Yeung for Jeff. A clarity question for NDA acceptance for ioporphin, IL-one hundred and thirty one. Does the FDA to record NR data from the complementary study or just the cover? [indiscernible] And I have follow-up. Thanks.

Sorry. Let me you were breaking up there pretty bad, so I'm not 100% sure I captured everything that you were trying to question. Was the question for the NDA submission, does it require data from the new from a new study or is it just from the CloverWAM study? [indiscernible] acceptance require the MRR data from the complementary study or just the CLOBIR study?

Yes. The accelerated approval will require data from the additional study as well.

Got you. Thanks. So can you share the timeline for patients to achieve and be validated for an MRR response under the [indiscernible] Certainly. Hi, this is Jim. Before I turn turn that question over to Jared, We do anticipate rapid enrollment in this study. Based on our obviously the drug's performance and the Phase two where we achieved outstanding clinical results and quite frankly a very impressive adverse event profile as well. The WM community was very disappointed that there would be a delay to market for iapopacin. There's clearly high unmet medical need there. And the patients have really reached out and have rallied around this drug and the company and we're very appreciative of that. In addition, the thought leadership also disappointed that they're not going to have this drug available in the very near term for their patients. Having said that, it's it's very clear that the healthcare community would rally around the clinical study And we expect enrollment, quite frankly very quickly. And from first patient and we've crafted some time and events that we believe are conservative and I'll turn this over to Jared to provide some some detail around this.

Yes. As Jim said, we took a conservative sort of approach to to building our timelines here. And from that perspective, we look at it from first patient enrolled AKA first patient dose that it would be approximately twenty four months to full enrollment And then with the two major response rate being approximately thirty days, that it would basically be one more month to achieve the the necessary outcomes for major response rate.

Great. Very helpful. Thank you. And what would be the comparator be or any color on the comparator? Thanks.

We're particularly excited about how we've crafted this with the FDA and the FDA the comparator arm And this is one of the reasons why we believe we have and our thought leaders and advisory council believe we have very limited clinical risk here Jared? Yes. I would add to that. We believe or we know that at least one of the comparators as we mentioned, it will be two comparators It's an investigator choice study design. So they get instead of one of the nine NCCs guideline options that two options to choose from.

Both of those based off of utility, none of it's based off of efficacy because no one's tested in this late line. Study group before. Obviously, the most relevant data comes from the INNOVERATE study using rituximab monotherapy which we are using here again as one of the choices Just to give you a sense in that INNOVATE study, if you look at the major response rate, rituximab monotherapy, it was twenty two percent. With progression free survival of median progression free survival around six months. And so we think that again based off of our data that we stack up very nicely against that The other arm will be we're finalizing that choice and I believe it will be a Rituxan combination treatment where the expectation is it will perform very similar to the Rituxan monotherapy.

And for clarity, both treatments will sum to 100 patients. Yes.

Great. Thanks. If you don't mind, I have a little follow-up For financial runway of cash to 20 one-two twenty five and one hundred and twenty five? And then what about the studies themselves and what the estimated cost of those Phase one studies? Thank you so much.

Sure.

What I'll go right ahead, Chuck. So the answer to your question is yes, that runway does include the cost for the IND filings And the cost is relatively modest to get the Phase one trials running and that is also encompassed in the cash runway that we presented earlier.

And the costs associated with each of those studies is in the ballpark of about $500,000 Thank you.

Our next question comes from the line of Shonna Ascoff from Roth. Your line is open.

Hi, good morning.

Thanks.

Congrats on the progress. And I was just curious, the comparator arm is is pretty much going to be fifty-fifty, one group taking rituximab and the other one taking something else among those nine NCCN drugs. That correct?

No, that is not correct, Jonathan. So they only get to choose one there's only two choices, right? One will be Rituximab, one will be the other arm that we're agreeing to with the FDA. We have to provide them with utilization data on our other choice. That's what they want to see. How that breaks down is it's no, it's not though. It's not a fifty-fifty, right? The physicians get to choose.

It could be 90% rituximab monotherapy and 10% the other arm. We don't know. We don't have any control over that. So it's 100% investigator choice between two options.

That's helpful. Do you wish to allow us to understand at all the range of deal types you're entertaining for 131? To get that trial started?

We're obviously we're very fortunate, right? We have a Phase three ready oncology asset I mean, an area with high unmet medical need with a substantial market both here and abroad. With the opportunity for orphan drug pricing and in a space with very, very limited treatment options. And likely, one of the next one or two radiotherapeutics that would be approved in this space in an area that's growing in a high degree of interest.

So I mean, as you would expect, there would be a lot of interest in an asset of that nature. I also believe as I cited in my remarks, that the clarity on the regulatory side has been very well received and And I believe those entities that are doing the asset also view this as very, very limited clinical risk. And so you have a pretty much a clear pathway to approval with very low risk of not achieving the necessary results versus the comparator arms that Jared just cited earlier. So those deals could take on a number of different looks.

I'll have Jared talk to some broadly or in generally some of the types of deals that we would entertain.

Yes. So to your point, Jonathan, and I think we've talked about this in the past, we're entertaining everything from global partnerships where someone would take over, obviously, the global rights and we would continue to collaborate with them on execution but that they would be predominantly responsible for everything. And then they would be responsible for the commercialization of the compound afterwards. All the way down to regional rights where it might be a European partner or an Asia partner and we would still maintain The U. S. Rights and proceed from that perspective. We do have a number of as Jim alluded to, we have a number of parties and we have parties in each of those buckets that have that are progressing through the process and really we're looking to really make a decision here which offers the best outcome for the company and for our investors.

And from a global licensing perspective, just for some clarity, Jonathan, from a global licensing perspective, that would include a typical upfront payment series of milestones, and royalties back to our company and then the entity that would assign those rights to would also be fully responsible for the economics associated with the with the pivotal study and the responsibility for the execution of it. As Jared mentioned, based on our relationships that have been established and our experience executing the Phase two and with those known contacts with those institutions and community based systems, that will drive the majority of those patients, both here and ex U. S. That will be some additional value that we would bring to add. Additionally, and importantly, all of the CMC related costs manufacturing costs would also be responsibility of a third party. We would obviously, because of our experience here, and what we believe best in class radiotherapeutic manufacturing, we would be responsible for the manufacturing of the drug.

Okay. Thanks. Lastly, why pancreatic for 02/25? Is that based mostly on market need or was there some clearly differential preclinical efficacy signal?

Yes. So yes, actually John. Easy answer is yes, both actually. So clearly, the market need is significant there. And patients are in severe need of a new treatment paradigm, particularly for PDAC or pancreatic alcocetenal carcinoma. The addition to that is every preclinical model that we've tested of PDAC the Actinium program has done an incredible job of being highly effective in every animal model and we reproduced that now quite a few times and have demonstrated that And it also shows a very consistent uptake and dose response. So it's an opportunity to really take advantage of both the delivery platform to get after a complex difficult to treat high unmet need and at the same time have a good understanding of where the likely therapeutic activity will be and the therapeutic window based off the safety profile.

One of the attractive natures of both of these Phase 1s is that Jared will orchestrate this in such a way where we'll receive dosimetry data on patients. So we will very rapidly see the amount of drug that's targeted to the tumor And also within six, nine patients or so have a really good understanding of safety of a long pathway to evaluation. We believe both of these tumor types are there's clearly high unmet medical need in very large markets and also high unmet medical need. And on the radiotherapeutic side of the equation, these solid tumor programs for these large bulky tumors. Are very rare based on the technology associated with delivery of these radioisotopes. And we believe based on proof of concept with iopocin and a significant amount of preclinical work and obviously all the work we've done on the imaging and diagnostic side of the equation that our targeting platform is unique will be able to deliver the isotope regardless of the isotope to the tumor, high uptake as well as the associated safety that we observed with IOPOCI.

Thanks a lot. I'm glad you guys are having the inbounds.

Jonathan, thank you. We'll see you next week at your conference. Thank you for the invitation. Got it.

Bye.

There are no further questions at this time. Mr. Karamso, please go ahead.

Sure. Thank you, operator, and thank you everyone This does conclude our call for today. Obviously, take this opportunity to disconnect and please have an enjoyable day. Thank you.

Ladies and gentlemen, this concludes the conference call for today. Thank you for participating. Please disconnect your lines.