Cellectar Biosciences Q1 2025 Earnings Call Transcript

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May 13, 2025

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 may be recorded. I would now like to hand the conference call over to Ann Marie Fields, Managing Director at Precision AQ.

Operator

Please go ahead.

Speaker 1

Thank you. Thank you, operator. Good morning, welcome to SelectR Biosciences first quarter twenty twenty five financial results and business update conference call. Joining us today from SelectR 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 and the year. Following this, Jared Longcar, Chief Operating Officer, will give an update on the company's progress and plans for its promising clinical development pipeline of radiopharmaceuticals.

Speaker 1

SelectR issued a press release earlier this morning detailing the content of today's call. A copy can be found on the investor page of SelectR'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 the company's SEC filings. The content of this conference call contains time sensitive information that is accurate only as of the date of this live broadcast, 05/13/2025. 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. We will begin the call with prepared remarks and then open the line for your questions.

Speaker 1

I will now turn the call over to Jim Caruso. Jim?

Speaker 2

Thank you, Henry, thank you all for joining us this morning as we review the progress SelectR has made throughout the first quarter of twenty twenty five. We entered 2025, continued focus on our PDC platform, our radio conjugate pipeline, and finalizing the requirements from the FDA and EMA or European Medicines Agency regarding iapopacine I-one hundred thirty one for the treatment of Waldenstrom's macroglobulinemia or WM. We rapidly scheduled and completed a productive meeting with the US Food and Drug Administration regarding the accelerated approval regulatory path for iapoficine I-one hundred thirty one in WM. The results from the Phase two CLOVER WM clinical trial of iapoficine I-one hundred thirty one as a treatment for relapsed refractory WN demonstrated the drug's unique efficacy and safety product profile, which we believe represents a significant opportunity as a promising therapeutic candidate in a relapsedrefractory market where no approved drugs currently exist. In parallel, we are seeking guidance from the EMA on conditional approval for iprofacene I-one hundred thirty one as a treatment for WM based on the clobaram Phase two study.

Speaker 2

We believe the compelling results from the study support the conditional marketing authorization strategy and will make available this critically needed new medicine to WM patients in Europe more rapidly. In addition to our iofocusing program in WM, we continue to progress 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. Jared will speak further to these programs later in the call. As we explore strategic alternatives for the company, we have engaged Oppenheimer as an exclusive financial advisor to assist us. These alternatives may include, but are not limited to mergers, acquisitions, partnerships, joint ventures, licensing arrangements or other non dilutive transactions.

Speaker 2

Now let me turn the call over to Chad for a review of our financial results. Chad?

Speaker 3

Thank you, Jim, and good morning, everyone. I will address our financial results for the period ended 03/31/2025. We ended the quarter with cash and cash equivalents of $13,900,000 as compared to $23,300,000 as of 12/31/2024. We expect the cash on hand is adequate to fund budgeted operations into the fourth quarter of twenty twenty five. As Jim stated, we have engaged Oppenheimer and Company to serve as our exclusive financial advisor as we seek to explore strategic alternatives available to SelectR that will allow us to maximize shareholder value moving forward.

Speaker 3

Regarding our results from operations, research and development expenses for the three months ended 03/31/2025 were approximately $3,400,000 compared to approximately $7,100,000 for the three months ended 03/31/2024. The overall decrease in research and development is largely driven by the reduction of patient follow-up activities for our Clover Roy M Phase two clinical study in WM and a reduction in personnel costs. General and administrative expenses for the three months ended 03/31/2025 were 3,000,000 compared to 4,900,000 for the same period in 2024. The decrease in G and A was primarily driven by a reduction in pre commercialization and personnel costs. Net loss for the three months ended 03/31/2025 was $6,600,000 or $0.14 per share compared to $26,600,000 or $0.91 per share during the three months ended 03/31/2024.

Speaker 3

Now I will turn the call over to Jared for an operational update, including plans for our promising pipeline of Bravio Pharmaceuticals.

Speaker 4

Thank you, Chad, and good morning, everyone. I will now review the regulatory and clinical status of iafobacine and two of our exciting earlier stage radio conjugates. The first is our alpha emitting actinium based compound CLR121225 and the second is CLR-one 21,125, our lead Auger emitting radiotherapeutic. The path to achieve conditional approval by apovacine I-one hundred thirty one is based on major response rate or MRR and to obtain full approval based on progression free survival or PFS. In a randomized controlled Phase III study evaluating the activity of iapopacine I-one hundred thirty one versus an investigator's choice comparator arm, which will provide the study investigators a choice between one of two NCCN approved treatment options.

Speaker 4

The primary endpoint for accelerated conditional approval is superiority based upon the MRR. Progression free survival from the same patients will be used to receive full approval. This trial is expected to enroll approximately 100 patients per arm. Since there is no data available for efficacy of any comparator in this patient population, SelectR is working with the FDA to utilize claims data demonstrating the current utilization patterns by physicians to select the two NCCN guideline listed drugs for the comparator arm. As for our earlier stage pipeline, CLR121225 is our lead alpha emitting radio conjugate product candidate.

Speaker 4

To date, it has shown excellent biodistribution and uptake into solid tumors with demonstrated activity across multiple solid tumor animal models, including challenging to treat pancreatic and refractory colorectal cancers. CLR 121,225 has been observed to be well tolerated in these experiments. The Phase I trial for CLR one hundred twenty one thousand two hundred twenty five is designed to comprehensively evaluate compounds by distribution, 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 tissues. This initial assessment will provide valuable insights into the compound's biodistribution and potential therapeutic window, laying the foundation for subsequent phases of the trial and future development.

Speaker 4

Following dosimetry, the study will progress to a dose escalation phase, systematically evaluating increasing doses of CLR121-two twenty five to establish the maximum tolerated dose. This approach offers an opportunity to demonstrate proof of concept for our innovative combination of phospholipid or PoE technology, with alpha emitters, potentially showcasing this radio conjugate's unique ability to safely treat large, bulky, solid tumors. Our OJ emitting radio conjugate product candidate, CLR121.125, represents the peak of precision in targeted radiotherapy with its emissions traveling only a few nanometers. With our delivery mechanism providing the necessary targeting to the tumor, entry into the cell and transport to the nucleus as validated through preclinical studies, we have seen CLR121-one 25 demonstrate significant tumor uptake and activity with enhanced tolerability across multiple challenging animal models, including triple negative breast cancer and metastatic breast cancer. We are preparing CLR-one 21,125 for a Phase Ib study in triple negative breast cancer.

Speaker 4

This trial will evaluate three distinct doses and dosing regimens and the primary objective of identifying the optimal recommended phase two dose. The study will include an imaging component to further elucidate the biodistribution of CLR121125, providing crucial insights into its targeting and potential efficacy. It is important to note that the initiation and timing of these trials is dependent on the company obtaining the necessary funding. With that, let me turn the call back to Jim for closing remarks. Jim?

Speaker 2

Thank you, Chad and Jarrett. Before opening the call to questions, I would like to thank our dedicated and talented SelectR team who continue to work with tremendous determination to move these important programs and our company forward. We remain committed to the WM community and sincerely appreciate the abundance of support and continued encouragement to advance focusing I-one hundred 30 one to market. Operator, we are ready to open the call for questions.

Operator

Thank you. Ladies and gentlemen, we will now begin the question and answer session. You will hear a prompt that your hand has been raised. Should you wish to decline from the polling process, please press the star followed by the number two. If you are using a speakerphone, please lift the handset before pressing any keys.

Operator

Your first question comes from Eidin Heisenhaus from Ladenburg. Please go ahead.

Speaker 5

Hi. Good morning, everyone. Thank you for taking the questions, and appreciate the updates this morning regarding application for conditional approval in Europe. So, I wanted to ask a question regarding a hypothetical match of one hundred thirty one, ipovacin one hundred thirty one against rituximab in early line. So since you're going to run the phase three trial anyways and going to take more than perhaps two years to read this out, Would it make sense to run against rituximab in earlier lines of therapy just to get the bigger market?

Speaker 5

And what do you think about the hypothetical efficacy against rituximab in earlier lines? Thank you.

Speaker 2

Thank you, Aiden. Appreciate your participation today and certainly the question. As you would imagine, we've evaluated, you know, a number of different study designs and opportunities for iappopacine, not only in the relapsedrefractory setting which would be our initial to market play, but obviously in earlier lines of therapy there could be a real benefit for patients that either do not tolerate BTKIs, BTKIs are not effective and in your particular case, rituximab or rituximab combinations as well. I will say that for the US FDA, the team has done a really nice job based on our November discussion to very rapidly secure an additional meeting with the FDA that occurred in March. And as part of that, we have we believe very clear line of sight on what a pivotal study would look like, certainly in The US based on the FDA's guidance.

Speaker 2

And one of those comparator arms in the relapsed refractory setting will most likely be rituximab. Based on data there in these later lines of therapy, rituximab certainly in third line or greater is in this kind of ten percent to twenty percent range based on the data that we have observed using data and claims in The US. In earlier lines of therapy, there are clinical studies available and I'll have Jared speak to our thinking around that.

Speaker 4

Yeah, as Jim said, Hayden, we did look at going to an early line. The challenge with going to an early line is the size of the study becomes much larger. As you might imagine, looking at differentials in major response rates or progression free survival in earlier lines with going against rituximab, where there is a relatively higher rate of responses as opposed to the twenty percent, approximate twenty percent that Jim just quoted for major response rate in later lines, it jumps up to sixty percent, seventy eighty percent depending on exactly what line you're looking at. That then alters your patient population sizing, so the number of patients required to execute that study, goes up pretty quickly and pretty significantly, making the cost of the study considerably more than what we're looking at right now. So we've hesitated on that.

Speaker 5

Yeah, makes sense. Makes sense. And regarding the Phase III trial design, the investigator choice out of the all possible sort of NCCN recommended choices, what is the weakest essentially competitor hypothetical competitor arm you would choose or sort of compel physicians to choose in order to improve the chances of 131 in this Phase three trial? And are there any eligibility criteria where 131 would be the best suitable option versus other potential options that the NCCN recommends?

Speaker 2

Yeah, that's a great question. And before I hand this off to Jared, as you think about this, there's little to no data available relative to most of those treatments that are identified in NCCN guidelines. They because they're treating other hematologic malignancies and often times in WM, in second line, you can already be in a salvage therapy mode in some form of a combination chemotherapeutic soup, etc. Keeping in mind this is a much older patient population that may already have been treated with multiple lines of therapy prior from an adverse event perspective, it could be a challenge for these patients. So there's clearly to your point, a dearth of information relative to the performance of these drugs certainly in second line and beyond and clearly in a relapserefractory setting.

Speaker 2

So there's high unmet medical need there based on the data claims and utilizing information from third party community based integrated oncology delivery networks typically see in third line or greater is kind of ten percent to twenty percent response rate based on

Speaker 4

the data that we're able to Gartner. Yeah, and Aiden, I may follow-up a little bit. So the interesting piece, and I'll put it back into the hypothetical, the interesting piece of your question that is the hypothetical piece is, identify essentially the weakest drug to go against to ensure success? And I'll come to why we don't really care in a moment. I think it'll make a lot more sense, but at the end of the day, no matter what drug you pick or pair of drugs you pick, whatever you pick as the investigator choice, you obviously have to have the FDA approve those choices and the FDA wants to stick to what is the most common treatment paradigm that is ongoing right now.

Speaker 4

Obviously physicians aren't likely to be prescribing drugs that they know are failing rapidly. That said, one of the things that I think leads to this is, you know, when you get into the second line and the third line, like Jim said, and you're in this sort of already coming into a salvage therapy, frequently what you actually see is physicians are just satisfied with patients not having a major response but achieving stable disease or suppression of the sequela associated with the disease. So peripheral neuropathy, maybe reduction in their fatigue, what have you. And that's what they're really trying to do. They're not actually trying to alter the disease course, they're just trying to ameliorate symptoms and signs of the disease essentially.

Speaker 4

What's interesting is what does that mean? That means as Jim said, most of these other drugs at least from what we're seeing have a low major response rates and very short progression free survival. So as we said rituximab or even some of the rituximab combinations range in and around this ten percent to thirty percent maximum major response rate and sub six months progression free survival. And so, you know, we feel very confident that with our near sixty percent major response rate, which I think was fifty eight point two percent in the overall patient population that we will easily be able to demonstrate with major response rate the potential of hypophosphine here. And then when you look at the PFS, again, if you're looking at sub six months and you look at what our ongoing PFS was in the study, the last time we reported, which was north of eleven months, again, we think we have a very strong compelling position as it relates to any comparative that we will select.

Speaker 4

And we do think with the discussions with the agency, the selection here is really about a fixed course therapy that compares with our fixed course therapy. And so that means, you're basically rituximab and rituximab combinations only as your alternative. I think on the other piece, when you think about eligibility, you asked the question about, is there a way to enhance the eligibility to ensure, again, better patient population for ibuprofen. And we think we've done that fundamentally. This post BTKi patient population that we're pursuing, keeping in mind that now with ibrutinib approved in the first line, you're seeing a lot more utilization of BTKi in combination with rituximab in that first line setting.

Speaker 4

What does that mean and why is that important? What we've seen through both anecdotally and then also through the claims data that Jim referred to, what you see is that patients who've had a BTKi tend to fail almost every subsequent treatment after that. However, as you will note from our study and in our press release I think this morning, when we look at the post BTKi population with Iapopoci, you're looking at a fifteen point nine percent or essentially a sixty percent or fifty nine percent, sorry, fifty nine percent major response rate in that patient population. So again, we don't see a change and we think that just select that patient population enriches a true separation and really identifies the need for Iapopoci.

Speaker 2

The only other thing, that was very comprehensive, Jared, thank you. The only other thought that I would provide to Aiden is this concept of re challenging, where what you typically see is rituximab or some rituximab combination being used in multiple lines of therapy. Hypothetically if it was used in first, you may see it in third and fourth and you know it's in this kind of I think thirty to forty percent range for treatments used and you know in the second, third, fourth, fifth lines of therapy and that's really a funk and each time it's used typically it becomes less and less effective by line of therapy as you use it to rechallenge patients. And as a result of that just really talks to the high unmet medical need that exists here in this patient population.

Speaker 5

Yeah, makes a lot of sense. One additional question I have regarding the conditional marketing application in Europe. So this is, you know, I think there's a ten year report from EMA that says six out of 10 drugs that were submitted got approved, conditional first, and some of them actually got full approval after that. But how do you assess the commercial opportunity in Europe after you will hear back from EMA? I think you mentioned third quarter twenty twenty six.

Speaker 5

So how do you assess the commercial opportunity given the pricing environment there, given the market size environment there? Just curious your thoughts on to hear your thoughts on this.

Speaker 2

Sure. I think first, perhaps an update in terms of where we sit with the EU in terms of potential for conditional approval there and how we're thinking about the regulatory pathway. And we also, Aidan, view that market as a very rich one as well.

Speaker 4

Yeah, so, Aidan, to your point, six out of 10 drugs that seek conditional approval in Europe receive it, which is a nice percentage, 60% of the time they're going to get it. We think that our possibilities there may be enhanced because we have designation and the data set that we have is so strong. We did have a scientific advice meeting with the EMA previously. During that meeting, it was commented by them about the study design. Sort of separate from The U.

Speaker 4

S, they were much more focused on a single trial design approach for the drug and they were very impressed with the data they were looking at that point from the global WAM study. They did not have all of the data. So they are looking forward to receiving that. So we expect that as you sort of said that we will have the meeting with them, discuss that pathway and to basically ensure that we are eligible and that we should seek the approval on that study. We also think because where we sit right now is with the new phase three study design that we come with the FDA, we'll be sharing that with EMA as essentially the confirmatory study for full approval in Europe.

Speaker 4

And we think that that study as it is designed will ensure that they are more amenable to the conditional approval because obviously it does then address several of their traditionally desired things, a comparative controlled trial, a comparative is widely used throughout Europe, 1 that you can then use from a pricing perspective as well. So, all of these things will help them to be in a position to grant a conditional approval. Then I think, as you asked the question on the commercial side, yes, is different in Europe and yes, it is significantly lower than here in The U. S. However, one of the new regulations, new approaches there is have to do a comparative control trial so that you can get appropriate pricing and justify.

Speaker 4

In a rare disease like this, you get some benefit, keeping in mind that, you know, this disease is predominantly a disease of older northern European descendants. It is, you know, it is more common or equally as common in Europe, even though the population size is a bit lower, is relatively common. And I would say that the other key component there is, we do believe that rituximab will be one of the comparator arms as that is much more highly utilized in Europe than it is here in The U. S. I think Jim, as Jim quoted a little bit ago, rituximab generally in The U.

Speaker 4

S. Irrespective of the line of therapy is being given at thirty ish to forty ish percent of the time and Europe is almost double that. So now you're taking out one of the leading utilized drugs across Europe and if you're demonstrating that you can beat it with a superiority study, you should be instantly placed in front of it as utilization across Europe. While the price might be different, you actually will likely see an increase in total volume offsetting that price differential.

Speaker 2

And Jared, for clarity relative to the conditional approval timeline, we will know from our friends at the EMA in the third quarter of this year as to whether or not regulatory pathway with conditional approval would be acceptable?

Speaker 4

Correct. And then essentially from there, it's approximately the filing would go in and then it's twelve months from the filing, generally for EMA.

Speaker 5

Right. All right. Okay, thank you. Thanks so much for taking the questions and appreciate the discussion.

Speaker 2

Of course. Thank you, Aiden. Thank you.

Operator

There are no further questions at this time. I will now turn the call over to the selector team for closing remarks. Please go ahead.

Speaker 2

Well, thank you for facilitating the call and also thank you to everyone participating today. This does conclude our call and you may disconnect. Thank you.

Operator

Ladies and gentlemen, this concludes today's conference call. Thank you for your participation. You may now disconnect.

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Key Takeaways

  • After a productive FDA meeting, SelectR clarified an accelerated approval pathway for iapofacine I-131 in relapsed/refractory Waldenström’s macroglobulinemia based on Phase 2 CLOVER WM results showing a ~60% major response rate.
  • Engagement with the EMA is underway to secure conditional approval for iapofacine I-131 in Europe, with a regulatory decision expected in the third quarter of 2025.
  • The solid tumor radioisotope pipeline advanced, with alpha-emitter CLR121225 entering a Phase I dosimetry and dose-escalation study in pancreatic cancer and Auger-emitter CLR121125 poised for a Phase Ib trial in triple-negative breast cancer.
  • Financially, SelectR reported $13.9 million in cash at quarter end, a net loss of $6.6 million, and expects funding to support operations into Q4 2025.
  • To maximize shareholder value, the company has engaged Oppenheimer as exclusive financial advisor to explore strategic alternatives including M&A, partnerships, and non-dilutive transactions.
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Earnings Conference Call
Cellectar Biosciences Q1 2025
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