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Chad Kolean

Thank you, Jim. In 2024, we executed multiple financial transactions that strengthened Cellectar's balance sheet, including investors' exercise of warrants in January, generating $44.1 million. And an inducement financing in July, which included the exercise of existing warrants and the purchase of new warrants for $19.4 million in process.
As we communicated last October, we refiled our historical financial statements for fiscal year 2023 and 2022. An action that was precipitated by a re-evaluation of the accounting for warrants issued prior to 2023. 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 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 burns imported, and the changes to earnings were all non-operating and non-cash.
Now turning to our financial results in the fourth quarter and full year ended December 31, 2024. We ended the year with cash and cash equivalent of $23.3 million as compared to $9.6 million as of December 31, 2023. Based upon the delay and IFO it seems NDA submission and lack of regulatory clarity; we implemented a cost saving strategic restructuring which reduced headcount by approximately 60%.
We expect restructuring to drive savings of approximately $7.5 million annually and to extend our cash runway into the fourth quarter of 2025. Moving to the operating results. Research and development expenses for the full year 2024 were approximately $26.1 million compared with $27.3 million in the prior year. The decrease was largely driven by the timing of expenditures for our WMAs Phase 2 study to support patient enrollment.
And follow-up visits and was partially offset by the extensive analytical work necessary to prepare for a plan MDA submission, product sourcing, and expansion of manufacturing and logistics infrastructure costs to support multi-sourcing for each aspect of Iopofosine one production. Selling general and administrative expenses for the full year 2024 for $25.6 million compared to $11.7 million 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 substantial WM market opportunity for IO, enhancing the value of Iopofosine and supporting our funding efforts and potential collaborations with prospective partners.
Other income and expense net was approximately $7.3 million of income in 2024 as compared to approximately $3.9 million 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 of cash is interest income, which for the year just ended improved to approximately $1.2 million from $0.4 million in 2023.
Net loss for the full year ended December 31, 2024, was $44.6 million or $1.22 per base share, and $1.40 per fully diluted share. Compared to $42.8 million or $3.50 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 evaluation of the company.
NASDAQ provides an additional initial 180-day remediation period to rechargeable price per stock. NASDAQ also maintains the right to grant an additional 180-day remediation period upon request, provided the company meets all other listed criteria. If necessary, we will request an additional 180-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 2025 annual meeting.
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 multi-faceted 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 Jarrod, for an operational update, including plans for a promising pipeline of radio pharmaceuticals.

Jarrod Longcor

Thank you, Chad, and good morning, everyone. I will begin by providing a regulatory update on I opine for the treatment of WM.
Following our November 2024 FDA meeting, we sought to obtain additional clarity on the agency's preferred study designed to support an accelerated approval. We formally submitted an end of Phase 2 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 6th, and I am pleased to report that we successfully achieved a crucial milestone for the future development of Iopofosine I-131, 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 Iopofosine in WM patients.
The path requires the completion of a confirmatory randomized controlled study Iopofosine I-131, 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 select a 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 rates. Subsequently, full approval is contingent upon achieving progression-free survival. We anticipate that the study to enroll will enroll rapidly and to achieve full enrollment within approximately 24-months of the first patient treated.
The total cost is between $40 million, $45 million dollars. We estimate that approximately $30 million will be required to achieve full enrollment, which facilitates the NDA submission for conditional approval. The approximately $15 million remaining will be required for the determination of PFS, long term follow up and study closure. This approach aligns with FDA guidance and provides a well-defined path to potentially bring Iopofosine I-131 to market for the treatment of relapse or factoring WM patients in the US.
We are also seeking to reach similar alignment with the EMA or European Medical Agency to harmonize the study designed for market approval in both the US and Europe. We expect to be ready to initiate this study later this year. In addition to these activities, Selectar is employing our proprietary phospholipid drug conjugate or PDC tumor targeting delivery platform to develop unique and 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. Iopofosine 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. This provides the unique ability to more effectively select the right isotope for the right tumor. We accomplish this by taking advantage of our near uniform targeted delivery to allow for the rapid and simultaneous testing of various 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. While most radioisotope development companies focus on varying the targeting element to improve activity, 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 the 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 CLR-121225, and the second is CLR-121125, our lead OJ emitter. CLR-121225 is our lead alpha conjugate product candidate that has shown excellent bio distribution and uptake into the tumors, exhibiting activity across multiple solid tumor animal models, including challenging to treat pancreatic ductal adenocarcinoma and colorectal cancers. Importantly, in all tumor types tested, CLR-121225 has been shown to be safe and well tolerated.
Like Iopofosine, we have established a network of isotope and finished products CDMOs to guarantee sufficient supply in the near and long term for the full development of CLR-121225. We continue to evaluate additional CDMOs to ensure capacity for indication expansion and long-term risk mitigation. The Phase 1 trial for CLR-121225 is designed to be comprehensively evaluate the compounds biodistribution, 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 bio distribution and potential therapeutic window laying the foundation for subsequent phases of the trial and future development. Following dose symmetry, the study will progress to a dose escalation phase, systematically evaluating increasing doses of CLR-121225 to establish the maximum tolerated dose.
This carefully structured approach offers an opportunity to demonstrate proof of concept of our innovative combination of phospholipid or PLE technology with alpha emitters, potentially showcasing this radio conjugate's 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 selected, potentially opening new avenues for targeted radiotherapeutics and rapidly advancing our position to the forefront of cancer treatment innovation. We will be prepared to initiate this study in the first half of 2025.
OG 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 isotope 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-121125 apart in the landscape of radio pharmaceuticals and potentially offering a new paradigm in targeted cancer therapy.
We are strategically positioned to advance CLR-121125, our lead OJ emitter using iodine 125 as radio conjugate product. Into the next stage of development. The activity of CLR-121125's intracellular delivery mechanism has been rigorously validated through pre-clinical 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-121225, we are preparing CLR-121125 for a Phase 1B 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 2 dose. The study will include an imaging component to further elucidate the biodistribution of CLR-121125, 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 malignancies. Success in this area could be particularly impactful given the limited treatment options currently available for triple negative breast cancer patients.
We anticipate that positive data from this study could significantly enhance the value proposition of CLR-121125 and by extension, our entire radiopharmaceutical platform. These trials represent a critical step in our pipeline development, potentially positioning both CLR-121225 and CLR-121125 as groundbreaking therapies in the evolving landscape of targeted radiopharmaceuticals for cancer treatment.
Furthermore, these programs showcase the versatility of our platform and reinforces our commitment to 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?

James Caruso

Thank you, Jerry. As you can see, we 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 advanced discussions with multiple companies regarding the licensing rights for Iopofosine.
The regulatory strategy established by the FDA provides a clear and cost-efficient regulatory pathway forward for Iopofosine with what we believe to be limited clinical and execution risk. In essence, the regulatory clarity has significantly enhanced the value of Iopofosine. Non-negative cash associated with these potential deals would be highly beneficial for the company.
In addition, we will be prepared to initiate Phase 1 studies for both the alpha actinium-based radio conjugate and pancreatic cancer and the OG emitter for triple negative breast cancer in the first half of 2025. The initiation of these respective studies are to be determined. Our current cash position extends into the fourth quarter of 2025, which we believe provides ample time to evaluate and advance non-dilutive of licensing deals and potential funding vehicles and in parallel assess timing for the initiation of our Phase 1 assets.
Before opening the call to your questions, I would like to thank our dedicated and talented selector 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 Iopofosine in market. Together we continue to push the boundaries of what is possible in oncology, and we look forward to the future with optimism and votes.
Operator, we are ready to open the call to questions.

Question and Answer Session

Operator

(Operator Instructions) Jeff Jones, Oppenheimer & Co Inc.

Jeff Jones

Hi, thanks for the update. This is [inaudible] for Jeff. A clarity question for MDA is, acceptance for, Iopofosine I-131. Does the NDA except require MR data from the complimentary study or just the cover, WM and I have follow up. Thanks.

Jarrod Longcor

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 CLOVER WaM study?

Jeff Jones

Yes, we mean, I mean, the NDA acceptance required the MRR data from the complementary study or just the clever study.

Jarrod Longcor

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

Jeff Jones

Gotc it. Thanks. So can you share the timeline for patients to achieve and be validated for an MRR response under the study design?

James Caruso

Certainly, hi, this is Jim. Before I turn that question over to Jarrod, we do anticipate rapid enrollment in this study based on our, obviously the drug's performance and you know the Phase 2 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 Iopofosine.
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. I'm 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 very clear that the health care community would rally around the clinical study. And we expect enrollment, quite frankly, very quickly. And from first patient and we've crafted some timing events that we believe are conservative. And I'll turn this over to Jarrot to provide some detail around this. Yeah.

Jarrod Longcor

As Jim, said we took a conservative sort of approach 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 24-months of full enrollment and then, with the two major response rate being approximately 30-days that it would basically be one more month to achieve the necessary outcomes for major response rate.

Jeff Jones

Great, very helpful. Thank you. And what would be the [comparatively] be or any color on the comparator? Thanks.

James Caruso

We're particularly excited about how we've crafted this with the FDA and the FDA support in terms of 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. Jarrod?

Jarrod Longcor

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 investigative choice study design. So they get instead of one of the 9 NCCN guideline options they get two options to choose from, both of those based off of utility. None of it is based off of efficacy because no one's tested in this late line study group.
Before, obviously the most relevant data comes from the Innovate 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 22%. With progression free survival of me 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 rituximab combination treatment where the expectation is it will perform very similar to the rituximab monotherapy.

James Caruso

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

Jeff Jones

Great, thanks. And if you don't mind, I have a one follow up, for financial loan way of cash to for quarter this year, the this include the work to complete IMD filing for CLR-121225 and CLR-121125. And what about the studies themselves and what the estimated cost of those phase one studies. Thank you so much.

James Caruso

Sure, go right ahead?

Chad Kolean

So the answer to your question is yes, that does include the cost for the IMD filings and the cost is relatively modest to get the Phase 1 trials running and that is also encompassed in the cash runway that we presented earlier.

Jarrod Longcor

And the cost associated with each of those studies is in the ballpark of about $4.5 million.

Jeff Jones

Great. Thank you, so much

James Caruso

Thank you.

Operator

Jonathan Aschoff , Roth Capital Partners LLC.

Jonathan Aschoff

Hi, good morning. Thanks, congrats on the progress. And I was just curious, the comparator arm is pretty much going to be 50/50. One group taking rituximab and the other one taking something else among those nine and NCCN drugs, is that correct?

Jarrod Longcor

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, it's not though. It's not a 50/50, 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% an investigator choice between two options.

Jonathan Aschoff

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

James Caruso

We're obviously we're very fortunate, right? We have a Phase 3 ready oncology asset. I'm in 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 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 I believe those entities that are viewing the asset also view this as very, very limited clinical risk. And so you have a pretty much a clear pathway to approval but very low risk of, not achieving, the necessary results versus, the comparator arms that Jarrett just cited earlier.
So those deals could take on a number of different looks. I'll have Jarrod, talk to some, broadly or generally, some of the types of deals that we would entertain.

Jarrod Longcor

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 will 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 Asian partner and we would still maintain the US 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 their process through the process. And really you know we're looking to really make a decision here on which offers the best outcome for the company and for our investors.

James Caruso

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 pivotal study and the responsibility for the execution of it.
As Jarrett mentioned, based on our relationships that have been established in our experience in executing the Phase 2 and with those known contacts with those institutions and community-based systems. That will drive the majority of those patients both here and ex, that'll be some additional value that we would bring to add.
Additionally, and importantly, all of the CMC related costs and 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.

Jonathan Aschoff

Okay, thanks. Lastly, why pancreatic for 225? Is that based mostly on market need or was there some clearly differential pre-clinical efficacy signal?

Jarrod Longcor

So, yes, actually, John, easy answers, yes, both actually. So clearly the market need it is significant there and patients are in severe need of a new treatment paradigm, particularly for [pdeck ]or pancreatic ductal adenocarcinoma. The addition to that is every pre-clinical model that we've tested of PDAC. The Actinian program has done an incredible job of being highly effective, in every animal model,
Ad we're 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 on safety profile.

James Caruso

One of the attractive natures of both of these phase ones is that you know Jarrod, will orchestrate this in such a way where we will receive those symmetry data on patients. So we will very rapidly see the amount of drug that's targeted to the tumor and also, within 69 patients or so have a really good understanding of safety associated with this as well.
So it's not a long pathway to evaluation. We believe both of these tumor types are there's clearly higher 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 the delivery of these radio isotopes.
And we believe based on proof of concept with Iopofosine 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 and we'll be able to deliver. The isotope, regardless of the isotope to the tumor, I uptake as well as the associated safety that we observe with Iopofosine.

Jonathan Aschoff

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

James Caruso

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

Jonathan Aschoff

Bye.

Operator

(Operator Instructions). So no further questions at this time, Mr. Caruso, please go ahead.

James Caruso

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.

Operator

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