Q1 2025 Cellectar Biosciences Inc Earnings Call
Andrei Shustov, Ed Sheeran, Ed Sheeran, Ed Sheeran,
Ladies and gentlemen, thank you for sending by and welcome. At this time, all participants and I listen only mode. Following the presentation, there will be a question and answer session. Please be advised that today's conference.
Speaker Change: May we record it? I will now like to hand the conference call over to Anne Mary Fields, Managing Director of Precision AQ. Please go ahead.
Speaker Change: Thank you. Thank you, operator of Good Morning, and welcome to Selectar Bioscience's first quarter, 2025 Financial Results and Business Update Conference call.
Speaker Change: Joining us today from Cellectar are Jim Caruso, President and CEO , who will provide an overview of the company's progress before turning the call over to Chad Kolean's CFO for a financial review of the quarter and the year.
Speaker Change: Following this, Jarrod Longcor, Chief Operating Officer, will give an update on the company's progress and plans for its promising clinical development pipeline of radiopharmaceuticals.
Speaker Change: Select our issue to press release earlier this morning detailing the content of today's call. The copy can be found on the investor page of Selectors' corporate website.
Speaker Change: I want to remind callers that the information discussed on the call today is covered under the safe harbor proof of the private security's litigation reform act.
Speaker Change: I caution listeners that manager 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 Change: These forward-looking statements are qualified in their entirety by the cautionary statements contained in today's press release and in the company's FEC filing.
Speaker Change: The conference of this conference called contains time-sensitive information that is accurate only as of the date of this live broadcast, May 13th, 2025.
Speaker Change: 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.
Speaker Change: As a reminder, this conference called webcasts are being recorded and archived.
Speaker Change: We will begin the call with a pair of remarks and then open the line for your questions. I will now turn the call over to Jim Caruso. Jim?
Jim Caruso: Thank you Henry, and thank you all for joining us this morning as we review the progress selector has made throughout the first quarter of 2025
Speaker Change: Re-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.
Speaker Change: regarding eye-opropishing I-131 for the treatment of Waldenstrom's Macro-Lagulemia, or WM.
Speaker Change: We rapidly scheduled and completed a productive meeting with the U.S. Food and Drug Administration, regarding the Accelerated approval regulatory path for IOPHISING I-131-NWS.
Speaker Change: The results from the Phase 2 Clover Wham Thinnable Trial of Iopofocene I-131 as a Treatment for Relatius Refract
Speaker Change: Demonstrated the drugs, unique efficacy and safety product profile, which we believe represents a significant opportunity as a promising therapeutic candidate in a relapse refractory market where no approved drugs currently exist.
Speaker Change: In parallel, we are seeking guidance from the EMA, Unconditional Approval for Iopofocene I-131, as a treatment for WN based on the Cobra Campus Phase 2 study.
Speaker Change: 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.
Speaker Change: In addition to our IOPOFUSING program in WN, we continue to progress our solid tumor-focused radioisotope programs, which include our alpha emitter for pancreatic cancer and the OG emitter for evaluation and triple-negative press cancer.
Speaker Change: Both of which highlight the novel utility of our delivery platform.
Speaker Change: Jarrod will speak further to these programs later in the call.
Speaker Change: As we explore strategic alternatives for the company, we have engaged Oppenheimer as an exclusive financial advisor to assist us.
Speaker Change: These alternatives may include what are not limited to mergers, acquisitions, partnerships, joint ventures, licensing arrangements for other non-deserved transactions.
Speaker Change: Now, let me turn the call over to Chad for a review of our financial results. Chad?
Chad Kolean: Thank you Jim, and good morning everyone. I will address our financial results for the period that ended March 31, 2025.
Chad Kolean: We ended the quarter with cash and cash equivalence of $13.9 million, as compared to $23.3 million as of December 31, 2024. We expect that cash on hand is adequate to fund budgeted operations into the fourth quarter of 2025.
Chad Kolean: As Jim stated, we have engaged Oppenheimer in company to serve as our exclusive financial advisor as we seek to explore strategic alternatives available to select that will allow us maximize shareholder value moving forward.
Chad Kolean: Regarding our results from operations, research and development expenses for the three months ended March 31, 2025, were approximately 3.4 million, compared to approximately 7.1 million for the three months ended March 31, 2024.
Chad Kolean: The overall decrease in research and development is largely driven by the reduction in patient follow-up activities for our Kolean phase II clinical study in WM and a reduction in personal
Chad Kolean: General and administrative expenses for the three-month send in March 31 to be 25 with 3.0 million compared to 4.9 million for the same period in 2024.
Chad Kolean: The decrease in GNA was primarily driven by a reduction in pre-commercialization and personal
Chad Kolean: Netloss for the three months ended March 31, 2025, was $6.6 million, or $0.14 per share. Compare with $2.26.6 million, or $0.91 per share, during the three months ended March 31, 2024.
Chad Kolean: Now I will turn the call to Jarrod for an operational update, including plans for her promising pipeline of Reo Pharmaceuticals.
Jarrod Longcor: Thank you, Chad, and good morning, everyone. I will now review the regulatory and clinical status of IOPOPACINE and two of our exciting earlier stage radio conjugals.
Jarrod Longcor: The first is our Alpha Submitting Actinium-Based Compound, CLR-12125. And the second is CLR-12125, our Lead OJ-Emitting Radio Therapy.
Jarrod Longcor: The path to achieve conditional approval by a publishing I-131 is based on major response rating or MRR and to obtain full approval based on progression, free survival or PFS.
Jarrod Longcor: And a randomized controlled Phase III study evaluating the activity of I've focusing I-131 versus an investigator's choice comparator arm, which will provide the study investigators a choice between one of two NCCN-approved treatment options.
Jarrod Longcor: The primary end point for accelerated additional approval is superiority based upon the MRR. Progressive freeze of violence from the same patients will be used to receive full approval. This trial is expected to enroll approximately 100 patients per arm.
Jarrod Longcor: Since there is no data available for efficacy of any comparator in this patient population.
Speaker Change: Cellectar is working with the FDA to utilize claim-stated demonstrating the current utilization patterns by physicians to select the two NCCN guidelines listed drugs for the parader army.
Speaker Change: As our earlier stage pipeline, as for our earlier stage pipeline, CLR12125, is our lead alpha admitting radial conjugate product for Canada.
Speaker Change: To date, it has shown excellent bio-distribution and uptake into cell tumors with demonstrated activity across multiple solid tumor animal models, including challenging to treat pancreatic patients and refract B. Polo-Retro cancers.
Speaker Change: CLR 121-225 has been observed to be well-polarized in these experiments.
Speaker Change: The Phase 1 trial for CLR 12125 is designed comprehensively evaluate compounds by a distribution, safety, and tolerability in patients with pancreatic admiocarcinoma. The study will commence with
Speaker Change: Aim at determining the observed fields in both normal and tumor tissues. This initial assessment will provide valuable insights into the compounds by a distribution and potential therapeutic Tenthoff. Lay the foundation for subsequent phases of the trial and future development.
Speaker Change: Following dose symmetry, the study will progress to a dose escalation phase systematically evaluating increasing doses of CLR121-225 to establish the maximum tolerated dose.
Speaker Change: This approach offers an opportunity to demonstrate proof of concept for our innovative combination of fossil lipid ether or PLE technology, with alpha emitters, potentially showcasing this radio-controgates unique ability to safely treat large, bulky, solid tumors.
Speaker Change: Our OJ emitting radiocrats to get product antidote, CLR121125, represents the peak of precision in targeted radiotherapy with its emissions traveling only a few nanometers.
Speaker Change: with our delivery mechanism providing the necessary targeting to the tumor.
Speaker Change: Entry into the cell and transport to the nucleus as validated through preclinical studies, we have seen COR-121-125 demonstrate significant tumor uptake and activity with enhanced tolerability across multiple challenging animal models, including triple negative breast cancer and metastatic breast cancer.
Speaker Change: We are preparing CLR-121-125 for Phase-1B Study and Triple Negative Press Cancer.
Speaker Change: This trial will evaluate three distinct doses and dosing regiments, and the primary objective of identifying the optimal recommended phase two dose.
Speaker Change: The study will include an imaging component to further elucidate the bio-distribution of CLR121125, providing crucial insights into its targeting and potential efficacy.
Speaker Change: It is important to note that the initiation and timing of these trials is dependent on the company obtaining the necessary funds. With that, let me turn to back with the call back to Jim for closing remarks.
Thank you, Chad and Jarrod.
Speaker Change: Before opening the call to questions, I would like to thank our dedicated and talented select our team. We continue to work to tremendous determination to move these important programs and our company forward.
Speaker Change: We remain committed to the WM community and sincerely appreciate the abundance of support and continued encouragement to advance I have focusing I-131 to market.
Operator, we are ready to open the call for questions.
Speaker Change: Thank you. Ladies and gentlemen, we will now begin the question and answer session. Should you have a question, please press the star followed by the number one on your touch tone phone, 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.
Speaker Change: If you are using a speakerphone, please lift the handset before pressing any keys.
One moment, please for your first question.
Aiden Heisenhoff: Your first question comes from Aiding Heising Up from Leidenburg. Please go ahead.
Aiden Heisenhoff: Good morning, everyone. Thank you for taking the questions and I appreciate the updates this morning regarding application for conditional approval in Europe . So I went to ask question regarding a hypothetical match of 1-3-1, the opposing 1-3-1 against Fukumon in the early line. So since you're going to run the T-3 trial anyways and...
Aiden Heisenhoff: going to take more than perhaps two years to resolve. Would it make sense to run against retoxop in early lines of therapy just to get the bigger market, and what do you think about the hypothetical efficacy against retoxop in early lines? Thank you.
Speaker Change: Thank you, and 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 Ayyapopasin, not only in the relapse refractory setting, which would be our initial
Speaker Change: Play, but obviously in earlier lines of therapy there could be a real benefit for patients that either do not tolerate BTKIs, BTKIs, you know, are not effective, and in your particular case, you know, detects a map or detects a map of combinations as well.
I will say that, you know, for the U.S. FDA
Speaker Change: 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.
Speaker Change: In March. And as part of that, we have, we believe, a very clear line of sight on what a pivotal study would look like, certainly in the US based on the FDA's guidance.
Speaker Change: And one of those comparator arms in the relapse of refractory setting.
Well, you know, well, most likely be the Tuxtamab.
Speaker Change: based on data there in these later lines of therapy, we're talking some ad certainly in third line or greater, is in this kind of 10 to 20 percent range based on the data that we have observed using data and claims in the U.S.
Jarrod Longcor: In earlier lines of therapy, there are clinical studies available, and I'll have Jarrod's speech to are thinking around that.
Jarrod Longcor: Yeah, as Jim said, Aiden, 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.
Jarrod Longcor: As you might imagine, looking at differentials in major response rate or progression-free survival in earlier lines with going against for Tuxtamab.
Speaker Change: Where there is a relatively higher rate of responses as opposed to the 20% approximate 20% that Jim just quoted before a major response rate in later lines.
Speaker Change: It jumps up to 60, 70, or 80% depending on the exact footline looking at Tenthoff. That then alters your patient population's sizing, so the number of patients required to execute that study, goes up pretty quickly and pretty significantly, making the cost of the study.
Speaker Change: considerably more than what we're looking at right now. So, we've hesitated on that.
Speaker Change: Yeah, makes sense, makes sense, and regarding the Phase III trial design, the investigatory choice
Out of the all possible sort of instances and recommended choices.
What is the, what is the weakest?
Speaker Change: 1-3-1 would be the best suitable option versus other potential options that the NCC recommends.
Speaker Change: Yeah, there's a great question and before I hand this off [inaudible]
Jarrod Longcor: to Jarrod. And as you think about this, there's little to know data available.
Relative to
Jarrod Longcor: Most of those treatments that are identified in NCC and guidelines are there because they're treating other hematologic volignancies.
Jarrod Longcor: And oftentimes, NWM, and Second Line, you can already be in a salvage therapy mode in some form of a combination.
Jarrod Longcor: Chemotherapeutic soup, etc. Keeping in mind, this is a much older patient population.
Jarrod Longcor: that, you know, may already be, have been treated with multiple lines of therapy prior from a adverse event perspective. It could be a challenge for these patients. And so, there's clearly to your point.
Jarrod Longcor: A Dirt of Information, Relative to the Performance of these drugs, certainly in Second Line and Beyond, and clearly in a Relatio refractory setting. So there's high on Met Medical Need there, based on the data claims and utilizing information
Jarrod Longcor: Third-party community-based integrated oncology delivery networks, typically C and Third-Line are greater. This kind of, but 10 to 20% response rate based on the data that we're able to go on.
Chad Kolean: And if I follow up a little bit, so the interesting piece, and I'll put it back into the hypothetical, the interesting piece of your question is the hypothetical pieces, can you identify essentially the weakest drug to go against to ensure success?
Chad Kolean: And I'll come to why we don't really care in a moment.
Chad Kolean: I think it'll make a lot more sense, but at the end of the day, you know, what a hot, no matter what drug you pick or a pair of drugs you pick
whatever you picked as the investigator choice.
Chad Kolean: You know, you obviously have the FDA to approve those choices, and the FDA wants to stick to what is...
Chad Kolean: The most common treatment paradigm that is ongoing right now. Obviously physicians aren't likely to be prescribing drugs that they know are failing rapidly.
Chad Kolean: That said, one of the things that I think leads to this is, you know,
Jim Caruso: When you get into the second line and the third line, Jim said, and you're in this sort of already coming into established therapy.
Speaker Change: Frequently what you actually see as physicians are just satisfied with patients
Jim Caruso: 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 happened.
Jim Caruso: At that they're really trying to do. They're not actually trying to alter the disease course, they're just trying to feel the rate, symptoms, and signs of the disease essentially.
Jim Caruso: 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 very low major response rates and very short progression pre-survival, so as we said, retoxamab, or even some of the retoxamab combinations.
Jim Caruso: Range, you can get him around this 10 to 30% maximum major response rate in sub-six months in question please survive.
and so, you know, we feel very confident. Thank you very much.
Jim Caruso: that with our near 60% major response rate, which I think was 58.2% Ah.
of I-Police here.
Jim Caruso: 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 I'm going to report it, which was north of 11 months.
You know, again, we think we have-
Jim Caruso: A very strong, compelling position as it relates to any comparative that we will select. And we do think, you know, with the discussions with the agency, the selection here is really about it's sixth school.
Jim Caruso: Course Therapy that compares with our fixed course therapy. And so that means you know you're basically retoximab and retoximab combinations only as your alternative. I think on the other piece when you think about eligibility,
Jim Caruso: You asked a question about, you know, is there a way to enhance the eligibility to ensure, again, better patient population for our folks?
Jim Caruso: And we think we've done that, fundamentally, you know, this post-BTKI pace population that we're pursuing, keeping in mind that now with I've approved and have approved in the first line you're seeing a lot more utilization of the BTKI in combination we're talking about in that first line setting.
Jim Caruso: What does that mean and why is that important? Paid what we've seen through both anecdotally and then also through the claims data that James referred to. What you see is that patients who've had a BTKI tend to fail almost every subsequent treatment after that.
Speaker Change: Major Response Rate in that patient population. So again, we don't see a change, and we think, you know, that just select that patient population enriches a true separation, and really identifies the need for eye-opathy. [inaudible]
Speaker Change: The only other thing that was very comprehensive, Jarrod, thank you. The only other thought that I would, you know, provide to Aiden is this concept of re-challenging.
Speaker Change: where what you typically see is retuximab or some retuximab combination being used.
Speaker Change: Involvable line to third, the hypothetically if it was used in first.
You may see it in third and fourth [inaudible]
And, you know, it's in this kind of...
Speaker Change: I think 30-40% range for treatments used in the 2nd, 3rd, 4th, 5th lines of therapy, and that's really a fun end each time it's used.
Speaker Change: Typically, it becomes less and less effective by line of therapy as you use it to re-challenge patients. And, you know, as a result of that, just really talks to the high unmet medical needs that exist here in this patient population.
This is a question I have regarding the condition of marketing application.
Speaker Change: And Europe , so this is, you know, I think there's a 10-year report from EMA that does six out of ten drugs that were submitted, got approved.
Speaker Change: Conditioning their 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, 2026.
Speaker Change: So, how do you assess the commercial opportunity given the pricing environment there, given the market size environment there? Just curious your thoughts on this?
Speaker Change: Sure. I think first, perhaps an update in terms of where we sit with the EU.
and that market as a very rich one as well.
Yes, so, to your point.
Speaker Change: You know, six out of ten drugs that seek conditional approval in Europe , receive it, which is a nice percentage, you know, 60% of the time we're going to get it. We think that our possibilities there may be enhanced because we have a prime designation.
Speaker Change: and the data set that we have is so strong. We did have a scientific device meeting with the EMA previously during that meeting. It was commented by them about the study design.
Speaker Change: Sort of separate from the US, they were much more focused on a single trial design approach for the drug.
Speaker Change: And they were very impressed with the data they were looking at at that point from the Global WAM study. They did not have all of the data, so they are looking forward to receiving that.
Speaker Change: So we expect, as you sort of said, that people have the meeting with them, discuss that pathway and to, you know, basically ensure that we are eligible and that we should seek approval on that study. We also think because,
Speaker Change: You know, where we sit right now is with the new phase three study design that we've come with the FDA, we'll be sharing that with EMA.
As essentially the confirmatory study for full approval in Europe .
And we think that that study, as it is designed,
Will ensure...
Speaker Change: that they are more amenable to the additional approval because obviously it does then address several of their traditionally desired things at comparator controlled trial.
You know, a comparator that is widely used throughout Europe .
Speaker Change: One that you can then use from a pricing perspective as well, you know, so all of these things will help them to.
to be in a position to grant a conditional approval. And then I think...
Speaker Change: You know, as you ask the question on the commercial side, [inaudible]
Speaker Change: Yes, pricing is different in Europe , and yes, it is significantly lower than here in the U.S., however.
Speaker Change: One of the new regulations, new approaches there is you have to do a comparative trial so that you can get appropriate pricing and justify. In a rare disease like this, you get some benefit.
Speaker Change: 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. It is relatively common.
Speaker Change: and I would say that the other key component there is...
Speaker Change: You know, we do believe that for toxin map will be one of the comparator arms, as that is much more highly utilized in Europe than it is here in the US. I think Jim, as Jim quoted a little bit ago, for toxin make generally in the US.
Speaker Change: Irrespective of the line of therapy, is being given at 30-48% of the time, and you're almost double that. So now you're taking out one of the leading legalized drugs across Europe , and if you're demonstrating that you can beat it with a superiority study.
Speaker Change: 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 while setting that price differential.
and Jarrod for clarity relative to the conditional approval timeline.
Speaker Change: We will know from our friends at the EMA in the third culture of this year as to whether or not a conditional regulatory pathway with conditional approval would be acceptable.
Speaker Change: And then it would, essentially from there it's approximately, you know, the filing would go in and then it's 12 months from the file.
Thank you very much. Have a great day.
Speaker Change: All right. All right. Okay. Thank you. Thanks so much for taking the questions and appreciate the discussion.
Of course. Thank you, Aidan.
Thank you.
Speaker Change: As a reminder, if you wish to ask a question, please press the start of all by the number one.
Speaker Change: There are no further questions at this time, I will now turn the call over to this lecture team for closing remarks. Please go ahead.
Speaker Change: Operator, 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.
Thank you.
Speaker Change: Ladies and gentlemen, this concludes today's conference call. Thank you for your participation. You may now disconnect.