Q3 2025 Cellectar Biosciences Inc Earnings Call

Following the presentation, we will conduct a question and answer session.

If at any time during this call do require immediate assistance. Please press star zero for the operator.

This call is being recorded on Thursday November 13th 2025.

Now I'd like to turn the conference over.

Operator: 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 one at this time. You'll hear a prompt acknowledging that your hand has been raised. Should you wish to withdraw your request, please press the star, followed by the two. If you are using a speakerphone, please flip the handset before pressing any keys. One moment, please, for your first question. Your first question comes from Adam Hajusnov, Luxembourg. Please go ahead.

For two weeks.

And CE.

Thank you operator, good morning, and welcome to select our Biosciences third quarter 2025 financial results and business update conference call joining.

Joining us today from select Star are Jim Caruso, President and CEO, who will provide an overview of the companys progress before turning the call over to Chad Cohen <unk> CFO for a financial review of the quarter.

Following this jarrod Longcor, Chief operating officer will give an update on the Companys progress on plans for its promising clinical development pipeline of Radiopharmaceuticals.

Adam Hajusnov: Hi, good morning, guys. Congratulations with the significant progress with the EMA application. I've got a couple of questions. For the EMA strategy and the decision from Scientific Advice Working Party, could you help us better understand the specific data that we're considering before making a recommendation? It sounds like they're allowing you to do it post-PDK, which could be second line. In your trial, your prior lines, I think the median prior lines were four lines. Could you help us better understand what they were looking for?

<unk> issued a press release earlier this morning detailing the content of today's call a copy can be found on the investor page of select <unk> 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 cautioned 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.

These forward looking statements are qualified in their entirety by the cautionary statements contained in today's press release and in our SEC filings.

Chad Kolean: Hi, Adam. This is Jim. First of all, thanks for your participation in the call today, and certainly appreciate your question. As you are likely aware, we've put together a very comprehensive data package for our friends across the pond. As you appropriately identified, we have recently received additional data from CLOVER WaM relative to post-BTKI, which gives us a high degree of confidence of our capacity to move iopofosine further upstream. As you suggest, post-BTKI could be as early as the second line. With that as an opening comment, I'll turn this over to Jarrod to provide some additional detail relative to the package itself and the consumption of that data from the EMA. Jarrod?

Contents of this conference call contains time sensitive information that is accurate only as of the date of this live broadcast November 13th 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 will begin the call with prepared remarks, and then open the call to your questions I'll now turn the call over to Jim Caruso Jim.

Yeah.

Thank you Anne Marie and thanks to all participants for joining US. This morning, as we review select <unk> progress in the third quarter of 2025, I am pleased to share that we have made significant strides throughout the quarter, marking a period of strong operational execution.

Jarrod Longcor: Yeah. Thanks, Jim. Thank you, Adam. Great question. Let me sort of try to unpack that a little bit for you. There are a couple of elements. One, the EU thriving pattern is a bit different than in the US. In the US sediment, as you just outlined, BTKIs now are generally used in the first-line setting, either in monotherapy or in combination, but predominantly in the first-line setting anymore, which would mean a post-BTKI population or post-BTKI approval in the United States is representative of a second line. However, in Europe, at this time, the post-BTKI base population would still be a third-line setting. Generally, in Europe, they start with a rituximab combination and continue to follow that with BTKI at this juncture.

<unk>.

Key corporate priorities, including the strengthening of our balance sheet, making significant advancements with our global regulatory strategy for <unk>, I 131, and Walton strong macro glad bulimia or Wm.

And advancing our clinical and preclinical programs.

These achievements underscore our commitment to innovation in oncology and positioned select Dar as a company with transformative potential as we head into the final stretch of the year and prepare for an impactful 2026.

Let me begin with our lead asset <unk>, <unk> 31, which continues to show strong promise as a first in class radio conjugate therapy for patients with Wm.

Jarrod Longcor: They are starting to shift to earlier utilization of BTKI, but that hasn't taken over in the vast majority of the 28-member countries at this juncture. Based on that, what the EMA evaluated, what the SAWP evaluated, was the totality of our data, so all patient population. They did focus in on that, in their opinion. In Europe, at this juncture, the greatest unmet need that would warrant a conditional market authorization is a post-BTKI patient population. As Jim just alluded to, when we look at that patient population, we have the vast majority of our patients in our CLOVER WaM study are post-BTKI. Of those, many of them, obviously, the majority of them responded well to the treatment, did very well. We do have statistical significance there.

The third quarter brought exciting developments that further validates its potential and may accelerate its path to market.

We've been closely collaborating with the MAA to align on a clear regulatory strategy importantly, following a thorough review by the EMA scientific working party, we received confirmation of our eligibility to file for conditional marketing approval.

<unk> in the EU based upon the Clover Wans study.

A major milestone that could bring <unk> to patients as early as 2027.

This endorsement not only reflects the strength of our data and the urgency of the unmet need but also carries a high probability of success with 80% of such filings ultimately receiving approval.

Jarrod Longcor: When we look even deeper into that, into varying subsets of that, where we look at the combination of refractoriness across those patients, what you see is a continued high response rate, and even in some sense, a much higher response rate than that of the general population. Based on that, the agency, the EMA, as the SAWP, felt that the drug warranted or should apply for conditional market approval, focusing in on that post-BTKI patient population at this time. I'll stop there.

Confirmation of our eligibility to file for conditional marketing authorization in the EMEA.

US further confidence in our regulatory strategy with the U S FDA.

As previously reported the FDA requested 12 month follow up data on all patients from the <unk> study.

With the 12 month follow up data now available we plan to submit an NDA under the accelerated approval pathway upon initiation of a confirmatory phase III trial.

Chad Kolean: Yeah. Adam, thank you. Thank you, Jarrod. Adam, as I think you brought to our attention a handful of months back, approximately 80% of all drugs that apply for conditional marketing authorization, that have received eligibility to apply for a conditional marketing authorization, are granted the CMA.

As you may be aware in the second quarter of this year I. Upon fishing was granted breakthrough designation for Wm by the FDA data from a recent Jefferies Research report showed that 79% of oncology drugs, which had been.

Granted breakthrough designation are successfully awarded accelerated approval.

Adam Hajusnov: Right. Yeah, that's great news. Given that, I know you don't have to run any trial, you just need to submit. For the FDA, you only need to initiate a phase 3 trial. How much resources do you think you need just to initiate a trial in the US, and whether your current balance sheet would be enough just to start it? It's only 200 patients, 24 months. Can you just start the trial and finish it once you have more resources?

The FDA.

The momentum provided by the success of our global regulatory strategy in Europe, and our strengthened regulatory position in the U S significantly enhance the value of EIOPA fishing, potentially reducing time to commercialization and making it an increasingly attractive.

The opportunity for strategic collaborations.

To support these efforts we are in active discussions with potential partners, both regional and global who share our vision for <unk>. These partnerships are designed to provide <unk> I 131 to patients as quickly as possible to secure non dilutive cash.

Chad Kolean: Yep. That's a very good question, Adam. Based on our assessment, the total overall cost of the study in totality, including multiple years of follow-up, is approximately $40 million. Importantly, we're estimating approximately $15 million to full patient enrollment, and it's $10 million to initiate the trial. I'll have Jarrod in a moment talk to detail around expectations by the FDA for accelerated approval. The net here is, essentially, it's trial initiation, which would allow us to submit the NDA and then have a study which is ongoing, enrolling patients at the time of the FDA assessment of our accelerated approval. As you know, with breakthrough designation and fast track, that's approximately six months further downstream.

<unk> and commercial expertise, while preserving long term value for our shareholders.

With our bullish of positive clinical data a favorable safety profile expedited review designations in the U S and Europe as well as a compelling commercial market potential. We believe <unk> hundred 31 represents an attractive candidate for potential collaborations.

<unk> or partners seeking impactful innovation and oncology assets with accelerated pathways to the global market.

We remain equally excited about the progress from our next generation radiopharmaceutical pipeline, including our recently initiated phase <unk> study of CLR 125, our iodine one to five or <unk> imaging agent, which targets solid tumors such as triple negative.

Chad Kolean: Based on the high level of interest in iopofosine by both patients suffering from WM, as well as thought leadership in the area, we would expect the study to enroll very, very quickly. Jarrod, I think it's fair to say, based on our assessment, approximately $15 million or so to full patient enrollment.

Breast cancer.

And CLR 225 are actinium Alpha emitting radio conjugate targeting several other solid tumors with significant unmet need including and created cancer.

Jarrod Longcor: Let me correct that. It's about $28 million to full patient enrollment. It's about $15 million to the point at which we would have sufficient enrollment for the agency to act on an accelerated approval application. Adam, if I back you up a little bit, as Jim said, to initiate the study itself because of CRO cost and the startup cost, that's approximately about $10 million of the $40 million that Jim outlined as the total cost. What happens is, obviously, you get the study started. The requirement, as you alluded to, is initiation of a confirmatory study. Assuming that would happen, the agency also has the obligation or the statement in the regulations now that the study must be considered ongoing, which they have enunciated as some level of enrollment. They have not specified what level of enrollment.

We have also been extremely active and showcasing data from these programs at medical meetings throughout the quarter, including posters and oral presentations at the American Association for cancer Research and special conferences and cancer research, we encourage everyone to visit the posters and publications.

Acacias section of our Investor website to view our presentations.

With our bolus of positive clinical data. A favorable safety profile expedited review designations in the US and Europe, as well as a compelling commercial Market potential. We Believe opposing i131 represents an attractive candidate for potential collaborations or Partners seeking impactful Innovation and oncology assets with accelerated Pathways to the global market.

Operationally, we have raised approximately $12 $7 million in recent financings to help strengthen our balance sheet and have also engaged in selective supply and trial support agreements with partners to secure the necessary supply of actinium 225.

And to complete our phase one study for CLR 125 for the treatment of triple negative breast cancer.

We remain equally excited about the progress from our next Generation radio pharmaceutical pipeline including our recently, initiated phase 1B. Study of CLR 125, our iodine 125, Oggy emitting agent, which targets solid tumors such as triple negative breast cancer, and CLR 225 our actinium Alpha emitting radio, conjugate targeting several other Solid 2.

In summary, we are closing out 2025 with strong momentum and entering the new year with a clear regulatory path for <unk> in Europe, and the U S and maintained the promise of a unique and robust pipeline addressing challenging solid tumor cancers with.

Jarrod Longcor: We are estimating that somewhere between 10% and 25% of patient enrollment would probably be satisfactory. In our calculation, that is somewhere between 20 and 50 patients. In order to achieve that, we think it would take about $15 million, including the $10 million startup, to achieve that number. Obviously, as Jim said, $28 million to get the full enrollment, and then $40-ish million to see out the rest of the study, including all of the long-term follow-up. We do believe that if we were to have enough funding to really launch the study and get to that first metric, I think, of having the agency respond to the submission, we would absolutely want to initiate and go.

Numbers with significant unmet need, including pancreatic cancer.

<unk> unmet medical need.

As a result, we have several near term milestones to look forward to that we believe play select are in a position of rapid growth. We are energized by the opportunities ahead and remain deeply committed to delivering innovative life extending therapies to patients with cancer.

We have also been extremely active and showcasing data from these programs at Medical meetings throughout the quarter, including posters and oral presentations, at the American Association for cancer research and special conferences in cancer research. We encourage everyone to visit the posters and Publications section of our investor website to view our presentation.

<unk>.

With that overview I'll now turn the call over to Chad Cohen, our Chief Financial Officer for a review of our financials Chad.

Thank you Jim and good.

10 a.m. 225 and to complete our Phase 1 study for CLR 125 for the treatment of triple negative breast cancer.

Good morning, everyone.

Per my comments on our financial results for the third quarter ended September 32025.

Adam Hajusnov: Thank you so much.

Chad Kolean: That's a lot of money. Yeah. No, I appreciate the question, Adam. Jarrod, thank you for the clarification on that. As I cited in my opening comments, a recent assessment by Jefferies research report identified those oncology drugs that have been awarded breakthrough designation. There's a 79% approval rating for accelerated approvals. So both.

We ended the quarter with cash and cash equivalents of $12 6 million.

Which is compared to $23 3 million as of December 31, 2024.

In July 2025, we raised a net of $5 8 million through the issuance of common stock pre funded warrants and new common warrants and.

In summary, we are closing out 2025 with strong momentum. And entering the new year with a clear regulatory path for opposing in Europe. And the US and maintain the promise of a unique and robust pipeline, addressing challenging solid tumor, cancers with significant unmet medical need

Following the close of the third quarter.

We raised an additional $5 million that through investors exercise of certain outstanding warrants and the issuance of new common one.

Adam Hajusnov: Yeah. It is a net buy.

Now expect that our cash on hand is adequate to fund budgeted operations into the third quarter of 2026.

Chad Kolean: Adam.

Adam Hajusnov: Yeah, net both with the EU at approximately 80% likelihood of success, and based on this Jefferies report with the BTD for iopofosine in the US, approximately 79%. We view those as certainly reasonable statistics that stack up in favor of iopofosine.

As a result, we have several near-term, Milestones to look forward to that. We believe Place, select our in a position of rapid growth, we are energized by the opportunities ahead and remain deeply committed to delivering Innovative life-extending therapies to patients with Cancers.

Turning to our results from operations.

Search and development expenses for the three months ended September 32025 were approximately $2 5 million compared to approximately $5 5 million for the three months ended September 32024.

With that overview. I'll now turn the call over to Chad, Colleen, our Chief Financial Officer for a review of our financials chat.

Thank you, Jim and good morning, everyone.

here in my comments on our financial results for the third quarter, ended September 3020 2025,

The overall decrease in research and development was a result.

Chad Kolean: Right. Right. Given that it appears that you will be first launching in Europe, then in the US, and given all these MFN discussions, could you help us understand the pricing potential for iopofosine in Europe and US, and also whether you would consider different brands, maybe, given potentially different labels for EMA and FDA? Just curious to hear your thoughts on this. Yeah. I'll open. We anticipate submitting our application for the CMA in the middle of 2026. If you estimate an approximately 12-month review by our friends across the pond, that's an approximately middle of 2027 marketing or commercial launch ex US. To your point, it's not only Europe. It's 30 major countries, except for China, Japan, and the US, that would have the capacity to market iopofosine.

Lower costs related to the <unk> study, where the patient follow up effort continues to decline as patients are moving off study.

We ended the quarter with cash and cash equivalents of 12.6 million.

Which is compared to 2 3. 3, 1 4.

Additionally, manufacturing costs have declined in the third quarter of 2024, we were investing more heavily in establishing a second manufacturing source for all hypotheses.

In July 2025, we raised a net of 5.8 million through the issuance of common stock, pre-funded warrants, and new common warrants. And

An effort that is now complete.

General and administration administrative expenses for the three months.

And at September, 32025% or $2 3 million.

Following the close of the third quarter we raised in additional 5 million net through investors exercise a certain outstanding warrants and the issuance of new common ones.

Compared to $7 8 million for the same period of 2024.

The decrease in G&A was primarily driven by a reduction in pre commercialization and market assessment efforts and lower personnel costs.

And now expect that our cash on hand is adequate to fund budgeted operations into the third quarter of 2026.

Turning to our results from operations.

Net loss for the three months ended September 32025 was $4 4 million or $1 41 per basic and diluted common share.

research and development expenses for the 3 months, ended September 30th 2025 or approximately 2.5 million compared to approximately 5.5 million for the 3 months, ended September 30th 2024

As compared with $14 7 million or $11 18 per basic and $12 13 per diluted common share during the three months ended September 32024.

the overall decrease in research and development was a result of

Lower costs related to the Clover and Wham study, where the patient follow-up effort continues to decline as patients are moving off study.

Chad Kolean: It's a significant market size, comparable certainly to that of the US when you look at incidence and prevalence numbers for WM. Now, taking a step back before we address the pricing question, we're not going to give you specific numbers, but we'll give you it's clearly a premium-priced opportunity. As you cited earlier, with the approximate $10 million to initiate our phase three confirmatory study in the US, and with that, as Jarrod cited, approximately six months or so to get to the necessary patient enrollment that we would believe would satisfy the FDA's requirement for the granting of an accelerated approval, you could actually have a horse race depending on when that study was initiated.

Okay.

With that let me turn the call over to Jared for a regulatory and operational update.

Thank you Chad and good morning, everyone.

Additionally manufacturing costs have declined as in the third quarter of 2024. We were investing more heavily in establishing a second manufacturing source for hypotheses and effort that is now complete.

As Jim just reviewed we believe I've overseen I 131 is a high probability of approval in EU and pending the initiation of the confirmatory study is.

General and administration administrative expenses for the 3 months.

And it's September 30th 2025 or 2.3 million.

Approval in the U S.

Compared to 7.8 million for the same period in 2024.

We have had extensive communications with both the EMA and the U S FDA throughout 2025 and the <unk>.

Fourth continuing these interactions through the approval process as.

The decrease in GNA was primarily driven by a reduction in pre-commercialization and market assessment efforts and lower Personnel costs.

As a reminder, this is a program that has received EMA prime designation FDA breakthrough therapy designation for the treatment of Wm.

Net loss for the 3 months. Ended September 30th 2025 was 4.4 million or 1.41 cents per basic and diluted common share.

<unk> rare pediatric disease designations, including most recently one for relapsed refractory pediatric high grade glioma as well as multiple FDA EMA orphan drug designations.

Chad Kolean: If, in fact, the study is initiated in the first quarter or second quarter of next year, within six months, you're obviously submitting your application to our friends at the FDA. Because of breakthrough and fast track, etc., it would be an approximate six-month review. In reality, you could have access to the US market and approval in the US market prior to that of the EMA. From a pricing perspective, that would certainly make pricing both in the US and ex US a little bit easier. Jarrod, without providing price points, if you could provide any additional detail for Adam and our call participants, I think that would be helpful.

as compared with 14.7 million or 11.18 cents, per basic and 12.13 cents per diluted, comment share during the 3 months, ended September 30th 2024

These rare pediatric disease designations provide.

Eligibility received a priority review voucher, which can be used to expedite the review process for future new drug applications or biological licensing applications for any drug or can be sold or transferred to another party.

With that, let me turn the call over to Jared for a regulatory and operational update.

Thank you, Chad, and good morning, everyone.

All of these updates have positioned <unk> as a major value creator heading into the fourth quarter and early 2006 and underscores its potential and strategic collaborations.

Hey, Jim just reviewed we believe. I have probably seen I 131. It's a high probability of approval in EU and pending the initiation of the confirmatory study its approval in the US.

Now, let's turn to our key exciting earlier stage radio conjugate CLR 125, our lead OJ Amir.

We have had extensive Communications with both the EMA and the US FDA throughout 2025, and look forward to continuing these interactions through the approval process.

CLR 225 hour Alpha emitting actinium based compound.

As a reminder, this is a program that has received EMA Prime, designation FDA, breakthrough therapy, designation for the treatment of WM.

CLR 135 may provide the greatest precision and targeted radiotherapy is the Osha had mentioned only travel a few nanometers, meaning the isotope Kent has to be delivered in the cell and near the nucleus or the deep Tonight.

Jarrod Longcor: Absolutely. I'm going to go in two directions or take this in two steps again. As you mentioned, Adam, the most favored nation discussion has resulted in some interesting outcomes. I think, as I'm sure you are aware, that for pharmaceutical pricing nature, some companies, some of the larger companies, have taken a position of, rather than decreasing prices in the US, they have taken a strategy of a more flat, universal price globally, and thereby negotiating harder in Europe and other places for higher prices. I think that is a trend that is going to likely continue. There will likely be some downtick in the US price in order to sort of get them more mirrored, but that there's significant increase in Europe.

5 rare pediatric disease, designations including most recently 1, for relapse refractory pediatric, high-grade glioma as well as multiple FDA and EMA. Orphan drug designations.

These rare pediatric disease, designations provide

Our phospholipid ether delivery mechanism provides this necessary targeting to the tumor entry into the cell and transport to the nucleus as validated through preclinical studies. It has been demonstrated that CLR 135 provides significant tumor uptake and depending on the dose results in tumor volume reduction for growth either.

Eligibility to receive a priority review voucher which can be used to expedite the review process for future new drug applications or biological licensing, applications for any drug or can be sold or transferred to another party.

Patients with no toxicity has been noted.

Including no hematologic toxicities at any of the doses tested across multiple challenging models, including triple negative breast cancer, <unk> and metastatic breast cancer.

And underscores its potential and strategic collaborations.

The phase one study of CLR, one five in relapsed triple negative breast cancer will utilize the cemetery to determine tumor versus normal tissue uptake and we'll evaluate the activity of three distinct doses of CLR 125.

Now, let's turn to our 2 exciting earlier stage, quote radio conjugates CLR 125 our lead OJ emitter and CLR 225 our Alpha emitting actinium based compound.

Jarrod Longcor: Now, as it relates to iopofosine directly, obviously, one of the processes that we have to go through is now to work through the HTA process, which was recently, earlier this year, announced, particularly for oncology drugs, that this has to be done sort of in parallel with our CMA. That process has been—I can't, as Jim sort of alluded to, we're not in a position at this jump yet to give specificity on pricing. We have given what we believe, and based off our pricing estimates for what we would expect in the US. Traditionally, in Europe, those prices can be anywhere from similar to 50% of that as a whole. That really comes down to that discussion.

Dose of $32 75, <unk> per dose or four cycles versus $62 five military for dose recycled versus 95 militaries per dose or two cycles with four doses per cycle and approximately 15 patients per arm with a plant expansion arm and the proposed.

CLR 125 May provide the greatest precision and targeted radio therapies as the OJ admissions, only travel a few nanometers meaning, the isotope can has to be delivered within the cell and near the nucleus or the DNA.

Dose the primary endpoint for this study will be to determine the recommended phase II dose and dosing regimen, and we will also evaluate safety and tolerability as well as initial response assessments for research as well as progression free survival in patients.

Our phospholipid ether delivery mechanism provides this necessary targeting to the tumor entry into the cell and transport to the nucleus as validated through clinical studies, it has been demonstrated that CLR 125 provides significant tumor uptake and depending on the dose results in tumor, volume reduction or growth inhibition with no toxicities being noted.

We expect to start dosing patients imminently and could have multiple patient sales by year the end of the year.

Including no hematologic toxicities at any of the doses tested across multiple challenging animal models, including triple-negative breast cancer (TNBC) and metastatic breast cancer.

Jarrod Longcor: The HTA requirement is for, even if you do not have a comparator in your clinical study or in your initial, in our case, in the initial study for CMA, what it would require is that we would do research to evaluate the potential clinical benefit of iopofosine I-131 over comparative drugs. I think the key takeaway on that is that, obviously, based off of the regulatory, the SAWP, and, in general, the EMA process, the PRIME, and everything else, there is a significant unmet medical need that this drug is needing. In their own words, that is essentially driven by the fact that these patients do not have treatment options available to them. There is a justification for negotiating higher percentages under that. The greater the value to the patient and the patient outcomes, the greater the price point can be.

For the Phase <unk> study, we will be partnering with adversity of clinical for full CRO services with the Mayo Clinic network, serving as a treatment center for the trial and Dr. Kapoor Advani acting as our lead investigator.

The Phase 1. B study of CR125 in relapse. Triple negative breast cancer will utilize those symmetry to determine tumor versus normal tissue, uptake and will evaluate the activity of 3 distinct. Doses of CLR, 125 a dose of 32.75 millicuries per dose.

The initiation of this trial will be a significant milestone for select are as.

As it brings us closer to being able to evaluate the safety and optimal dosing of CLO, but we expect to have a dosimetry data and efficacy data throughout.

Six moved.

Moving to CLO 225 hour lead Alpha emitted radio conjugate product candidate.

Which also has shown excellent via distribution uptake into solid tumors preclinical with demonstrated activity activity across multiple solid tumor.

Animal models, including challenging to treat pancreatic and refractory colorectal cancers.

4 Cycles versus 62.5 military per dose for 3, Cycles versus 95 militaries per dose for 2 Cycles with 4 doses per cycle and approximately 15 patients per arm with a plant expansion arm and the proposed Phase 2 dose the primary endpoint for the study, will be to determine the recommended Phase 2 dose and dosing regimen. And we will also evaluate safety and tolerability, as well as initial responses per resist as well as progression-free survival in patients.

CLR 225 has been observed to be well tolerated in these experiments, which we highlighted in our presentation at the ACR advances in pancreatic cancer Research conference held in Boston in September.

We expect to start dosing patients imminently and could have multiple patients those by year, the end of the year.

Jarrod Longcor: Our expectation is, based off the research we have historically done, recognizing that there is no direct comparator that we want to utilize, that we are in a position of strength to negotiate or, with a partner, negotiate a stronger price point in Europe.

Pending the necessary financing our phase one trial for CLO 225 is designed to comprehensively evaluated compounds by distributions safety and tolerability in patients with pancreatic adenocarcinoma.

For the phase 1B, study, we will be partnering with astia clinical for full cro services, with the Mayo Clinic Network serving as a treatment center for the trial and Dr. Puja adani acting as our lead investigator.

Chad Kolean: Yeah. Super helpful. Super helpful. For modeling purposes, it sounds like 2027 is the launch year for both US and EU, which makes it sort of a global launch perspective. Thank you. Thanks so much, and congratulations with this significant progress this quarter. Yeah. Thank you, Adam. Appreciate your participation, appreciate the questions. Very helpful.

<unk> will mess with the dosimetry phase aimed at determining the dose in both normal and tumor tissues.

Following dosimetry study will progress through dose escalation phase systematically evaluating increasing doses of CLR 225.

To establish the maximum tolerated dose. We believe this approach gives us an opportunity to demonstrate proof of concept for our innovative combination of phospholipid ether or PLD technology with Alpha emitters potentially showcase is radio conjugate Nick ability.

The initiation of this trial will be a significant milestone for select our as it brings us closer to being able to evaluate the safety and optimal dosing of Cl, but we expect to have a do symmetry data and efficacy data. Throughout the 26th, moving to CLR 225 our lead Alpha emitting radio, conjugate product candidate. Which also has shown excellent by distribution and a uptake into solid. Tumors free clinically with demonstrated activity activity.

Operator: Okay. Our next question comes from Jeff Jones, Oppenheimer. Please go ahead.

Across multiple solid tumor. Animal models, including challenging to treat pancreatic and refractory colorectal cancers.

Jarrod Longcor: Good morning, guys. Congrats on the progress and the regulatory wins so far. Great progress. Can you comment at all on how the partnering discussions have evolved since the EU regulatory update, and how you're thinking about partnering, be it US, Europe, or globally?

Retreat large both in solid tumors like pancreatic cancer.

We also recently announced a partnership with ITM, wherein they will provide that going into two five to help support our alpha labeled phospholipid EBIT radiopharmaceutical candidates CLR.

CLR 225 has been observed to be well, tolerated in these experiments, which we highlighted in our presentation at the aacr advances in Pancreatic Cancer Research Conference held in Boston in September.

CLR 225, Actinium 225 is a powerful alpha emitting isotope used in targeted cancer therapies, and both <unk> and <unk>.

Pending the necessary financing. Our Phase 1 trial for cl 225 is designed to comprehensively, evaluate the compounds by Edition distribution, safety and tolerability in patients, with pancreatic adnoc, carcinoma,

<unk> is a rare and in limited supply ICT. This.

This collaboration further underscores our strategic approach to a diversified supply chain to ensure the supply of key resources and thereby guaranteeing patient access to these therapies.

The study will commence with the dose symmetry phase aimed at determining the iso of both normal and tumor tissues.

Chad Kolean: Hi, Jeff. Thank you for the question, much appreciated. Hope you're doing well on your end. Obviously, when we anticipated a positive outcome with our friends across the pond and did the necessary work on the cost associated with our clinical trial or confirmatory study for the US, it became apparent to us to slow play corporate development discussions until we had the blessing, certainly, from the EMA on our capacity to file. Obviously, that becomes now iopofosine as a near-term oncology asset in a very robust ex US market, at a minimum.

All of these updates and more reinforce our position as a premier Radiopharmaceutical company to watch as we look towards the end of the year. This is incredible value can be found in the <unk> story that will aid in spring the development of CLR, 125, and <unk>, but with alignment from U S and European businesses.

Following those symmetry, the study will progress to a dose escalation phase systematically, evaluating increasing doses of CLR 225 to establish the maximum tolerated dose. We believe this approach gives us an opportunity to demonstrate proof of concept for our Innovative combination of phospholipid ether or P technology. Without the emitters potentially, showcasing, its radio, conjugates of unique ability to safely treat large open, Solid tumors like pancreatic cancer.

We feel more confident than ever in the <unk>.

Position of our programs.

With that overview, let me turn the call back to Jim for closing remarks, Jim.

Alright, Thank you Jarrod.

We also recently announced a partnership with itm wherein. They will provide actinium 225 to help support our Alpha labeled phospholipid E5 radio pharmaceutical candidates.

This has been a very successful quarter for our team we've maintained consistent dialogue with the appropriate global regulatory authorities and feel that <unk> now maintains its strongest position to marketing approval and commercialization.

Chad Kolean: When we also, based on our further communications with the FDA, were able to really drill down in terms of line of sight and this $10 to 15 million for upfront-ish to the necessary patients enrolled, as Jarrod cited earlier, in order for us to receive an answer from our friends at the FDA, we felt as if we would be in a much better position with both of those. We kind of, over the early part of the year here or middle part of the year, really slow played our discussions. It also allowed a handful of other companies to kind of get up to speed on their diligence. We have a number of companies all in and around the same spot in terms of their understanding of where we currently sit, certainly from a regulatory perspective.

With our earlier stage assets CLR 125, and CLR two to five we have made significant progress advancing these radio conjugates and have recently initiated the phase <unk> study for CLR, one to five in triple negative breast cancer. Additionally.

CLR 225 actinium 225 is a powerful Alpha emitting ice still used in targeted cancer therapies and both and is a rare. And in limited Supply isotope, this collaboration further, underscores our strategic approach to a diversified Supply supply chain to ensure the supply of key, resources and thereby guaranteeing patient access to these Therapies.

All of these updates.

Additionally, we've strengthened our balance sheet with runway out to the third quarter of 2026, and our position to execute across multiple near term priorities, including filing for I am focusing conditional marketing approval in the EU.

Reinforce our position as a Premiere, Radio pharmaceutical company to watch. As we look towards the end of the year. This is incredible value to be found in the Apothecary story that will lead in, spurring the development of CLR 125 and CLR 225 with alignment from us and European agencies. We feel more confident than ever in the position of our programs.

With that overview. Let me turn the call back to Jim for closing remarks. Jim

Initiation of our CLR 125 phase <unk> clinical trial with important dosimetry and early efficacy data readouts over the first half of 2026, we continue to advance our plans to file for accelerated approval of focusing in the U S pending <unk>.

Chad Kolean: Quite frankly, the latest data that we've mined from our clinical trial is also very, very supportive of our regulatory approach. Jarrod has been overseeing and has done a great job in terms of communication on the corporate development side, making certain that we were in a position of strength to optimize the potential value for our stockholders with iopofosine on a number of different fronts. I'll turn this over to him to provide some additional detail. Jarrod?

Funding required to initiate the phase III confirmatory study.

All right, thank you Jared. This has been a very successful quarter for our team. We've maintained consistent dialogue with the appropriate Global regulatory authorities and fill that. I apologize. Now maintains its strongest position to marketing approval and commercialization

We remain committed to achieving these key milestones and confident that these achievements will create value overtime. We look forward to finishing the year and believe we are in a strong position to bring <unk> high 131 <unk>.

Jarrod Longcor: Sure. I'll confess, Jeff, it's great to talk to you. I'll confess that I'm not sure that I can add much more detail. Jim did a great job there explaining exactly where we sit. I would say that we, obviously, as you get closer and closer to a regulatory approval, the interest and activity keeps up, especially when you start to be able to position this sort of, as we just talked about with Adam, with the conditional market approval and the potential to negotiate from a position of strength on pricing through the HTA process, the potential and our approach to manufacture and cost of goods, all of those things puts us in a very positive light with various partners and opportunities. We've seen, as Jim said, an increase in that.

And our pipeline of radiopharmaceutical therapies to the patients who continued to battle cancers.

High unmet need.

With that operator, we are ready to open the call to questions.

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 one at this time.

With our earlier stage assets, CLR 125 and CLR 2225, we have made significant progress advancing these radio conjugates and have recently initiated the Phase 1B study for CLR 125 in triple negative breast cancer. Additionally, we've strengthened our balance sheet with runway out to 2 to 3 quarters of 2026, positioning us to execute across multiple near-term priorities, including filing for IPOs, conditional marketing approval in the EU, and the initiation of our CLR 125 Phase 1B clinical trial.

You'll hear a prompt acknowledging that your hand has been raised should you wish to withdraw your request. Please press the star followed by the two if you are using a speaker phone. Please lift the handset before pressing any Steve.

Do Symmetry and early efficacy data readouts, over the first half of 2026.

One moment. Please for your first question yes.

we continue to advance our plans to file for Accelerated approval of opposing in the US, pending funding required to initiate, the phase 3, confirmatory study

Your first question comes from Aden.

Can you smell Luxembourg. Please go ahead.

Hi, Good morning, guys, congratulations with the significant progress that the EMA application.

I've got a couple of questions.

The EMI strategy and.

Jarrod Longcor: I think the second part of your question, which I can dig into a little bit more, which is the strategy, I think we've talked about this before, and we continue to be in this situation. We have ongoing discussions with parties who I would say are either globally focused or are focused on the two predominant regions right now for Radiopharm, which is the US and Europe. We do have various regional conversations ongoing that are advancing rapidly. Those might be part of those territories or all of those territories. Said in other ways, it could be solely Europe, could be solely US, could be other territories outside of that. As Jim alluded to, we have quite a number of parties right now who have either completed or nearly completed their diligence, who have supplied and moved forward into the next phases of partnering.

The decision from scientific Advisory working party.

Could you help us better understand the specific date.

We remain committed to achieving these key milestones and confident that these achievements will create value over time. We look forward to finishing the year and believe we are in a strong position to bring opposing i131 and our pipeline of radio pharmaceutical therapies to the patients. Who continue to battle cancers with high unmet need.

Data that were considering before making a recommendation because it sounds like they are they are allowing you to do it post CDK, which the second line in your trial.

With that operator, we are ready to open the call to questions.

Your prior lines I think of the median prior lines were formalized so could you.

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 1 at this time.

Help us better understand what they were looking for.

Hi, David This is Jim first of all thanks for your participation in the call today and certainly appreciate your question.

Um you'll hear a prompt a that your hand has been raised. Should you wish to withdraw your request? Please press the star followed by the 2. If you are using a speaker-phone, please lift the handset before pressing any keys.

As you as you're likely aware, we put together a very comprehensive data package for our friends across the pond and as you appropriately.

1 moment, please for your first question.

Your first question comes from Adam, uh, Luxembourg. Please go ahead.

<unk>.

We have recently received additional data from Clover Wham relative to post <unk>, which gives us a high degree of confidence of our capacity to move our focusing further upstream and as you suggest post <unk> it could be as early as the second line, but with that as.

Hi, good morning guys, uh congratulations with uh the significant progress um with the EMA application, um I got a couple of questions.

Jarrod Longcor: We continue to try to drive that, maximize both the return for the organization, and to ensure, as Jim said in his opening remarks, ensure that the drug is developed in such a way that it does get the patient actual benefit.

As an opening comment I will turn this over to Jared to provide some additional detail relative to the package itself and the consumption of that data.

Chad Kolean: Really appreciate it, Jarrod. Apologies if I missed this on the call. With respect to 225 and the pancreatic program, I know you're actively moving 125 ahead and that trial's taking off. Any gating items on 225 to begin that trial? Is that something you would move ahead with absent additional financing, or is that one pending?

From the EMA Jeremy.

Um, well, the EMA strategy um and the decision from scientific advice working party. Uh, could could you help us better? Understand the specific um data that we're considering before making a recommendation because it sounds like they're they're allowing you to do it. Post BDK which could be second line and in, in your trial, your, your prior lines. I think the medium prior lines were 4 lines so could it help us better understand uh, what they were looking for?

Yeah. Thanks, Jim.

Great question. So let me, let me sort of try to unpack that a little bit for you.

There are a couple of elements one the E U.

<unk> pattern is.

Different than in the U S U S and the U S settlement as you just outlined.

<unk> now are generally used in the first line setting either in monotherapy or in combination, but dominantly first line setting.

Jarrod Longcor: Yep. I believe the team, Jeff, has put us on the precipice of a phase one ready study there with the pancreatic cancer 225. It is a function, essentially, of financing as the gating issue there. Jarrod, any additional color you'd like to provide?

Which would mean a post <unk> <unk>.

Population or post PPA.

Approval in the United States is representative of a second one however in Europe.

I even this is Jim. First of all, thanks for your participation in the call today and certainly appreciate uh, your question. Um, as you as you, you are likely aware, we put together a very comprehensive data package, uh, for our friends across the pond. And, and as you appropriately, um, identified, uh, we have recently, received additional data from Clover, Wham relative to post btki, which gives us a high degree of confidence of our our capacity to move higher Proficiency in further upstream. And as you suggest post, btki could be as early.

At this time.

The Postbank AI based population would still be a third line setting.

Jarrod Longcor: No, I would agree with you. I think that the financing is the gating element. As Jim said, we currently sit in a position to essentially initiate the study as soon as the capital is in hand, so to speak. We have the CRO, we have the submissions, we have sites, we have everything ready to run for that study. Part of the reason we have announced the various supply agreements is because, particularly around actinium, what we've done is make sure that we have a consistent supply of actinium so that we are not delayed in any way, shape, or form as it relates to actinium sourcing. That supply gets us from where we sit today, based off our forecasting, all the way through into commercialization on the actinium program.

Generally in Europe, they start with Rituximab combination and continue to follow that would be.

At this juncture they are starting to shift to earlier utilization of <unk>, but that hasnt taken over in the vast majority of the 28 member countries at this juncture.

As the second line. But with that as uh, you know, an opening comment. I'll turn this over to Jared to provide some additional detail relative to the package itself and the consumption of that data, um, from the EMA Jared

So based on that.

The EMA evaluated with the S. AWP evaluated was the totality of our data so all patient popular.

But they did focus in on that in their opinion.

In Europe at this juncture the greatest unmet need that would warrant a conditional marketing authorization is a post <unk> outpatient.

therapy or in combination, but dominantly in the first line studying anymore,

Uh, which would mean a post, btki?

As Jim just alluded to when we look at that patient population, we have the vast majority of our patients in our <unk> study, our post <unk> and of those many of them. Obviously the majority of them responded well to the treatment did very well. So we do have some physical.

Jarrod Longcor: That's exactly why we've done this, that there are no hiccups or delays on that front, as we've seen with other parties. We expect, again, pending the capital, to initiate that phase one, and I'll call it phase one A, study. It is a dose escalation safety study with a dosimetry component. At the end of the day, what we'd be looking at is clear safety and understanding of the uptake and distribution of the molecule, which we don't expect to be very different than what we've seen historically.

Population or post ptfi approval in the United States is representative of a second 1. However, in Europe.

Uh, at this time.

The post btki Pace. Population would still be a third line setting.

Applicants there.

And.

When we even deeper into that burying subsets of that where we look at combination.

Refractoriness across those patients what you see as it continues.

Generally in Europe, they start with a Redux map combination and continue to follow that with the AI. Uh, at this juncture, they are starting to shift to earlier utilization of Picken but that hasn't taken over in the vast majority of the 28 member countries at this juncture.

So based on that,

High response rate and.

And even in some sense a much higher response rate than that of the general population and based on that the agency.

Chad Kolean: Got it. Great, Jeff. Appreciate it.

What the what the EMA evaluated it was a s a p evaluated was the totality of our data. So all patients.

Jarrod Longcor: No, Jarrod, I was just going to make a comment. No worries. I was just going to make a comment on how significant we view the triple as an example, the triple-negative breast cancer study. It's a solid tumor. As Jarrod cited, we believe our drug, our conjugate, will behave in a very similar manner to what we've observed with other isotopes as well, 124, 125, as well as 131. This is really, I think, for the company and for validation of our platform, very significant. Jarrod, perhaps you could just expand a little bit for our audience on the imaging and dosimetry data that we expect to collect very early on in this study that we believe will be further validating of our platform and, in particular, our capacity to be very effective in challenging solid tumors.

S S AWP.

But they did focus in on that, in their opinion.

Felt that the drug warranted or should apply for conditional market approval.

Focusing in on that post <unk> patient population at this time.

In Europe at this juncture, the greatest unmet need that would warrant a conditional Market Authorization is a post-BTKi.

I'll stop there.

Got it thanks guys.

Jared.

And Adrian as I think you brought to our attention a handful of months back approximately 80% of all drugs that apply for conditional marketing authorization that we have received eligibility to apply for a conditional marketing authorization are granted.

As Jim just alluded to, when we look at that patient population. We have, you know, the vast majority of our patients in our cloverworm, study are post, btki, and of those, many of them. You know, obviously the majority of them responded. Well, to the treatment did very well. So we do have statistical significance there. Uh, and

CNA.

Right yes.

That's great news.

<unk>.

Given that I know you don't have thrown in the chart, we just need to submit them.

EBITDA you only need to initiate a phase III trial so.

Jarrod Longcor: Sure. I'm going to blend this because it's the same whether I'm talking about the actinium program in pancreatic cancer with CLR225 or the triple-negative breast cancer program with CLR125. In both cases, we're utilizing dosimetry. For folks that may not be as familiar with the radiopharmaceutical targeted radiotherapeutic strategies here, the benefit of dosimetry is, unlike other therapies where we take blood samples and use that to sort of calculate and guesstimate the amount of uptake into the tumor and also into other healthy tissues, in this case, what we're able to do is actually image the transit of the drug inside the human body, and we're able to identify exactly where it is at different time points.

How much resources do think you need just to initiate a trial in the U S and whether.

You know, we when we look even deeper into that into varying subsets of that, where we look at combination of refractoriness across, uh, those patients, what you see is a continued, uh, high response rate, uh and even in some sets a much higher response rate than that of the general population. And based on that the agency, the EMA as the s a

Weather.

Uh, felt that the the drug warranted or should apply for conditional Market approval.

Your current balance sheet would be enough just to startup that's only 200 patient 24 months.

So can you just start the trial and finish it once you have more resources.

Uh, focusing in on that, those be to care, right? Patient population at this time.

Yes.

Very good question, Ed and based on our assessment.

I'll stop that. Yeah and Aiden. Go ahead. Thank you, Jared.

Total overall cost of the study in totality, including multiple years of follow up is approximately $40 million importantly, we're estimating approximately $15 million to full patient enrollment and it's $10 million to initiate the trial all have jarrett.

and Aiden as as I think you brought to our attention, a handful of months back, you know, Approximately 80%

Of all drugs that apply for a conditional marketing, authorization that have received eligibility to apply for a conditional marketing. Authorization are granted, uh, to CMA.

A moment talk too detail around expectations by the FDA for accelerated approval, but the net here is essentially its trial initiation, which would allow us to submit the NDA and then have.

Jarrod Longcor: Utilizing that data, we're then able to calculate both the absorbed dose in the healthy tissue and be able to know when we might achieve a level that could be serotoxic. On the other side, we're able to calculate the absorbed dose into the tumor and thereby calculate the expected dose and dosing regimen necessary to be an active therapy in that tumor type. Utilizing that data, you could get what's called a therapeutic window, and you get the opportunity that is the difference between your therapeutic dose and when you start to see toxicity. We expect, as we have seen with iopofosine, that this therapeutic window will be significantly wide enough. Interestingly enough, in the CLR225 program, back to the pancreatics, we'll have a piece for a moment.

A study which is ongoing enrolling patients at the time of the FDA.

Right. Yeah, that's a that's a that's that's that's great news and and um, you know, given that I know you don't have to run any trial, you just need to submit and for the for the FDA. Um, you only need to initiate a phase 3 trial. So, um, H how much resources do you think you need just to initiate a trial in the US and um, whether

Estimate of our accelerated approval and as you know with breakthrough designation and fast track that's approximately six months further downstream.

Whether you your current balance sheet would be enough just to start it. It's only 200 patient, 24 months, and so, can you just start to trial and finish it? Once you have more resources,

<unk> on the high level of interest in <unk> machine by both patients suffering from Wm as well as thought leadership in the area. We would expect the study to enroll very very quickly, but Jared I think it's fair to say based on our assessment.

Approximately $15 million or so two full patient enrollment.

Jarrod Longcor: One of the great challenges in pancreatic cancer is not just the nature of the tumor and the late stage in which patients are diagnosed, but it's also there is what they call interstitial pressure in the tumor, which prevents most drugs from actually being able to penetrate the tumor because there's fluid pressure pushing back against anything entering. Interestingly enough, as what we saw when we did this in the animal studies, our phospholipid ethers, again, give us a unique ability to actually penetrate through that and actually get inside the tumor and get deep inside the tumor, which is one of the reasons why we think, particularly in pancreatic cancer, we have a competitive advantage over other programs in that tumor specifically.

Let me correct that its about $28 million to full patient enrollment is about $15 million.

A point at which we would have sufficient enrollment for the agency to act on an accelerated approval application.

So Adrian if I, if I back you up a little bit as Jim said.

To initiate the study itself because of <unk> cost and the startup costs, that's approximately about $10 million of the $40 million that Jim.

Outlined is the total.

Yep. That's a very good question. Aiden based on our assessment, you know, the total overall cost of the study in totality including you know multiple years of follow-up is approximately 40 million dollars. Importantly, we're estimating a proximately, 15 million to full patient enrollment and it's 10 million to initiate the trial. I'll have Jared in a moment talk to, you know, detail around expectations for, um, by the FDA for Accelerated approval. But the net here is essentially it's trial initiation, which would allow us to submit the NDA and then have a, a, a study which is ongoing enrolling patients at the time of the FDA, uh, assessment of our accelerated approval and as, you know, with breakthrough, designation and FasTrak, that's approximately 6 months, further, Downstream BAS.

Then what happens is obviously you get the study started the requirement as you as you alluded to is initiation of a confirmatory study.

Jarrod Longcor: Obviously, in triple-negative breast cancer with the CLR125, we've seen similar sort of results, but that comes at it from a different perspective, particularly because you have limited targets now in breast cancer, and being able to overcome that with our targeting mechanism that is based off of metabolic needs.

Assuming that would happen then the agency also has the obligation with a statement in the regulations now that the study must be considered ongoing which they have enunciated as some level of enrollment they have not specified what level of enrollment we are estimating.

Based on the high level of interest and opposition from both patients suffering from WM, as you know, thought leadership in the area, we would expect the study to enroll very, very quickly. However, Jared, I think it's fair to say that based on our assessment, approximately $15 million or so is needed for full patient enrollment.

That's somewhere between 10, and one 5% of patient enrollment would probably be satisfactory.

Chad Kolean: Greatly appreciated. Thank you, Jarrod.

Uh, let me correct that it's about 28 million to full patient. Enrollment is about 15 million.

Operator: As a reminder, if there are any further questions, should you have a question at all, please press the star followed by the one at this time. You will hear a prompt acknowledging that your hand has been raised. Should you wish to withdraw your request, please press the star followed by the two. Our next question comes from Jonathan Ashcroft by Roth. Please go ahead.

In our calculation that is somewhere between 20 and 50 patients in order to achieve that we think it will take about $15 million, including the $10 million startup.

To achieve that number.

And then obviously as Jim said $28 million to get the full enrollment and then 40 ish million to see out of the rest of the study including multiple long term. Following we do believe that if we were to.

Jonathan Aschoff: Hi guys, good morning. Congrats on the regulatory progress. I was curious, just because full approval is based on PFS, can you remind us where you are in CLOVER WaM follow-up and where that PFS last came out, or at least what it at least is, and how that compares to standard of care for WM?

Have.

Now funding to really launched a study and get to that.

And if I, if I back you up a little bit as Jim, said to initiate the study itself because of cro cost and the startup cost that's approximately about 10 million of the 40 million that Jim, uh, outlined as the total cost. Then what happens is, obviously, you get the study started the requirement, as you, as you, alluded to is initiation of a confirmatory study.

First metric I think of having the agency book.

Respond to the submission.

We would be we would absolutely want to initiate.

Jarrod Longcor: Of course, Jonathan. Thanks for your participation. We have not updated our data since January of last year relative to PFS. At that point in time, it was very robust and well beyond what you normally would see with salvage therapies and the lines of therapy that we were treating. Jarrod, if you want to provide some detail there, I think it would be helpful for Jonathan and our audience.

Okay. Thanks, guys.

Yes.

Yes.

No.

I appreciate the question and Jared.

Thank you for the clarification on that and as a recent and I cited in my opening comments.

A recent assessment by Jefferies.

Research report.

Uh, assuming that would happen, then the agency also has the obligation or the statement in the regulations. Now that the study must be considered ongoing, which they have enunciated at some level of enrollment, they have not specified what level of enrollment. We are estimating that somewhere between 10 and 25% of patient, enrollment will probably be satisfactory and our calculation that is somewhere between 20 and 50 patients in order to achieve that we think it would take about 15 million dollars, including the $10 million startup uh, to achieve that number.

<unk> goes oncology drugs that have been awarded breakthrough designation Theres, a 79% approval rating for accelerated approvals.

Jarrod Longcor: Yeah, Jarrod, before you do that, I had 11.4 months after eight months, but you last said you had follow-up beyond 12 months. I just didn't get any further PFS with that additional follow-up. I'm kind of just trying to reconcile where it is.

So yes.

Notify Hayden.

Yes, and net both with the EU at approximately 80% likelihood of success and based on this Jefferies report with the BTT.

Jonathan Aschoff: Yeah. Absolutely. Thank you. Thank you for confirming what I was about to say to you. What I was about to say is it was 11.4 months with eight months of follow-up. We now have 12 months of follow-up on all patients. That is correct. That was one of the criteria that the FDA for submission for accelerated approval had requested. We now have that. As you might, as I'm sure you are aware, basically where we are in the process, we have not announced additional data. We do not wish, we're not in a position. I only want to say we do not wish.

And then obviously, as Jim said, 28 million to get the full enrollment and then 40ish million to see out the rest of the study, including all of the long-term followers, we do believe that if we were to uh, have you know, uh, enough funding to really launch the study and get to that first metric. I think, uh, of

For <unk> in the U S. Approximately 79% so we view those as certainly reasonable.

Having the agency will, uh, respond to the submission.

Uh, we would be, we would absolutely want to initiate and go.

Statistics that stack up in the favor of <unk>.

Okay, thank you for helping. Yeah, please. You know, put a little money. Yeah.

Alright, alright.

And given that it appears that you will be first launching in Europe.

Then in the U S and given the all of these.

MFN discussion so could you help us understand the pricing potential.

Jonathan Aschoff: We're not in a position to announce additional data at this juncture, largely in part because we are now in a process of trying to submit this for FDA regulation, and we don't want to be caught in a situation where the FDA may view us as being promotional as it relates to this data prior to a submission. At this juncture, the most recent data is that data from January of last year, and that won't be updated in the near term, or I'll say in the near term, based off of the requirements and discussions with.

For <unk> in Europe, and U S and also whether you would consider different brands, maybe given potentially different labels and for EMA and FDA just curious to hear your thoughts on this.

No, I I I appreciate the question, Aiden and Jared. Uh, thank you for the clarification on that. And as a recent, and I cited in my opening comments, um a recent assessment by Jeffries um research report, um identified those oncology drugs with uh that have been awarded breakthrough. Designation, there's a 79% approval rating for Accelerated approvals.

So, both Aiden.

Yes, I'll open.

We anticipate submitting our application for the CMA in the Middle of 2026, if you estimate an approximately 12 month review by our friends across the pond.

Chad Kolean: Okay. By the way, the order for pancreatic is file the IND, get funding, start the trial, correct?

Approximately middle of 2027.

Marketing or commercial launch ex U S and to your point, it's not only.

Yeah. And that both with the EU at Approximately 80% likelihood of success and based on this Jeffries Report with the BTD, um, for I have proposed in the US approximately 79%, so we view those as certainly reasonable, um, statistics that Stack Up, um, in the favor of I hope professing.

Jonathan Aschoff: Sort of. Sorry, Jim, if I jumped in there too fast. The pancreatic cancer study is one that we're not running in the US, so it will be filing, and we have filed ex-US with the appropriate authority to execute the study and have that accepted already. We're in a position now where it is await the capital and then initiate the study.

Europe.

30 major countries, except for China, Japan, and the U S that would be.

Have the capacity to market <unk>. So it's a significant market size comparable certainly to that of the U S. When you look at.

Incidence and prevalence numbers for <unk>.

For Wm now taking a step back before we address the pricing question and we're not going to give you specific numbers, but we'll give you.

Chad Kolean: Excellent. Thank you, guys.

Right, right. And and and given that, it, it appears that you will be first launching in Europe. Um, then in the US and given the all these, um, mfn discussions. So could you help us understand the pricing potential, um, for Apple forcing in Europe and us and also, whether you would consider different brands maybe given potentially different labels in uh, for EMA and FDA just curious, uh, to hear your thoughts on this.

Jarrod Longcor: No worries. The only additional information that I'll provide in regards to the PFS question, Jonathan, is that when we did multiple advisory boards with global thought leadership for Waldenstrom's macroglobulinemia, what came across very, very clearly was in the patient population, and just for all participants, this was iopofosine being used essentially as fifth-line therapy for this patient population. One, the response rate that we achieved was that 60% range, which was considered outstanding. More importantly, they gave us insight that four to six months of PFS for that patient population would be an excellent outcome. As you cited yourself, with our initial cut of data, we're at approximately one year of PFS, so almost doubling or greater the expectation of thought leadership in WM in terms of what would be considered an excellent result for patients.

It's clearly a premium priced opportunity, but as you cited earlier, what's the approximate $10 million to initiate our phase III confirmatory study in the U S.

And with with that as Jared sighted approximately six months or so to get to the necessary patient enrollment that we would believe would satisfy the fda's requirement for an accelerated approval for the granting of an accelerated approval you could actually have a horse race, depending on one win that.

The study was initiated so if in fact the study is initiated in the first quarter or second quarter of next year.

Within six months, you're you're obviously submitting your application to our friends at the FDA and because of breakthrough and fast track et cetera. It would be an approximate six month review. So in reality you could have access to the U S market and approval in the U S. <unk>.

Yeah, I I'll open, um, you know, we anticipate submitting our application for the CMA in the middle of 2026. If you estimate an approximately 12 months review, uh, by our friends, across the pond, you know, that's a an approximately middle of 2027 marketing or commercial launch xus. And, and to your point, it's not only, um, Europe. It's it's 30, major countries except for China, Japan. And the US, that would be, um, you know, have the capacity to Market. I apologize. So, it's a significant Market size comparable. Certainly to that of the us. When you look at, um, incidents and prevalence numbers, for, for, uh, um, for WM now taking a step back before, you know, we addressed the price

Prior to that of the EMA and so from a pricing perspective that would certainly.

Question and we're not going to give you specific numbers, but we'll give you um, you know, it's clearly a premium priced opportunity. But as you cited earlier, you know, with the approximate $10 million to initiate our phase 3 confirmatory, study in the US,

Make make pricing both in the U S and ex U S a little bit easier.

Operator: Okay, there are no further questions at this time. I will now turn the call over to Jim Caruso. Please continue.

Jarrett without providing price points, if you could provide any additional detail.

Jarrod Longcor: Terrific. Thank you, operator. This concludes our call for today. Certainly appreciate the great questions from our analysts, and for your participation, as well as all participants. Of course, this will be up on our website, and a transcript will be following this call. Thank you all very much.

<unk> and our core participants I think that would be helpful.

Absolutely and I'm going to I'm going to go into.

Directions.

Or to take two steps again.

As you as you mentioned Hayden.

The most favorite nation discussion has resulted in some interesting outcomes I think.

Sure you are aware that that for pharmaceutical pricing nature that some companies some of the larger companies have taken a position of rather than decreasing prices in the U S. They have taken the strategy of a more flat universal price globally.

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

And thereby negotiating harder.

In Europe and other places.

For higher prices.

And I think that that is a trend that is going to likely continue there will likely be some down down tick in the U S price in order to sort of get them more mirrored but that there is significant increases in.

Study is initiated in the first quarter or second quarter of next year. Um within 6 months, your your, obviously submitting, your application to our friends at the FDA and because of breakthrough and FasTrak Etc. It would be an approximate 6-month review. So in reality you could have, um, access to the US market and approval in the US market prior to that of the EMA. And so from a pricing perspective that would certainly, um, you know, make make, um, pricing both in the US and X us a little bit easier.

In Europe now as it relates to the IPO proceed directly obviously one of the processes that we have to go through is now to work through the <unk> process, which was recently.

Um Jarrett without providing you know, price points. If you could, you know, provide any additional detail um for Aiden and our our call participants. I think that would be helpful.

Absolutely. And and I'm going to, I'm going to go in 2 directions at the or 2 take this and 2 steps again.

Earlier, this year announced particularly for oncology drugs with this has to be done in parallel with our CMA net process.

Can you guys just sort of alluded to we're not positioned addition, yet to give specificity on pricing.

We have given what we believe in case of our pricing estimates for what we would expect in the U S.

Traditionally in Europe.

Those those prices can be anywhere from similar too.

Uh, as you as you mentioned, Aiden, the most favorite Nation discussion. Uh, has resulted in some interesting outcomes. I think, uh, as I'm sure you are aware that that for pharmaceutical pricing nature that some companies. Uh, some of the larger companies have taken a position of rather than decreasing prices in the US. They had taken a strategy of a more flat Universal price globally, uh, and thereby negotiating.

50 ish percent of that.

As a as a whole, but that really comes down to that discussion.

<unk> requirement is for even if you will not have a comparator in your clinical study.

Or in your initial in our case in the initial study for CMA.

What it would require is that we would be research to evaluate the potential clinical benefit of.

Harder in Europe and other places for higher prices. And I think that that is a trend that is going to likely continue. You know they will likely be some down downtick in the US price in order to sort of get them more mirrored but that there's significant increases in the Europe. Now as it relates to I focusing directly obviously 1 of the processes that we have to go through is now to work through the HTA process which was recently

<unk> 931 over comparative drugs I think the key takeaway on that is that obviously based off of the regulatory S. AWP and in general the EMA process with prime and everything else. There is a significant unmet medical need.

This drug is.

Eating and in their own words that is essentially driven by the fact that these patients do not have treatment options available to them.

So there is a justification for negotiating higher percentages.

Or is that the more the greater the value to the patient and the patient outcomes the greater the <unk>.

<unk> point can be and so our expectation is based off of research. We have historically done recognizing that there is no direct comparator that utilize that we are in a position of strength to negotiate or with a partner negotiate.

Uh, earlier this year, we announced that, particularly for oncology drugs, this has to be done sort of in parallel with our CMA. That process has been... you know, I can't, as Jim sort of alluded to, we're not in a position at this show yet to give specificity on pricing. Uh, we have given what we believe, and based off our pricing estimates, for what we would expect in the US. Traditionally, in Europe, those prices can be anywhere from similar to, uh, 50-ish percent of that, um, as a whole. But, you know, that really comes down to that discussion. The HTA requirement is for, even if you do not have a comparator in your clinical study, uh, or in your initial, in our case, in the initial study for CMA.

A stronger price point.

Yes Super helpful Super helpful.

For modeling purposes sounds like 2027 is the launch of <unk>.

Both U S and EU, which makes it sort of a global launch perspective.

Perspective, thank you thanks, so much and congratulations.

Uh what it would require is that we would do research to evaluate the potential clinical benefit of opposing 9131 over a comparative drugs. I think the key Takeaway on that is that obviously based off of the regulatory the sawp and in general the EMA process, the prime and everything else. There is a significant unmet medical need uh that this drug is needing.

Second progress this quarter.

Thank you Ed and I appreciate your participation appreciate the questions very helpful.

And in their own words, that is essentially driven by the fact that these patients do not have treatment options available to them.

Okay. Our next question comes from Jeff Jones Oppenheimer. Please go ahead.

Good morning, guys and congrats on the progress in the regulatory.

So there is a justification for negotiating higher percentages under that the more the greater the value to the patient and the patient outcomes. The greater the

Wins.

So far so great progress.

Can you comment at all on.

Now the partnering discussions evolve have evolved since the.

Price point can be. And so, our expectation is based off of research, we have historically done, recognizing that, there is no direct comparator. That wants to utilize that. We are in a position of strength to negotiate or with a partner negotiate

A stronger price point in New York.

The regulatory update.

And how youre thinking about partnering be it U S Europe or globally.

Hi, Jeff. Thank you for the question much appreciated hope you're doing well on your end.

Obviously when.

Yeah. So so for helpful super helpful and, you know for modeling purposes, sounds like 2027 is the launch uh year for both us and EU, which makes it sort of a global launch. Uh perspective. Thank you, thanks so much and congratulations uh, with this significant progress, uh, this quarter.

We anticipated a positive outcome with our friends across the pond and.

Yeah, thank you Aiden. Appreciate your participation. Appreciate the questions. Very helpful.

Did the necessary work on the costs associated with our clinical trial, a confirmatory study for the U S. It became apparent to us to slow play.

Okay, our next question comes from Jeff Jones. Oppenheimer, please go ahead.

Corporate development discussions until we had the blessing certainly from the EMA on our capacity to file obviously that becomes now.

<unk> is a near term oncology asset and a very robust ex U S market at a minimum.

And then when we also based on our further communications with the FDA, we're able to really drill down in terms of line of sight and and this.

How have the partnering discussions evolved since the EU regulatory update? And how are you thinking about partnering, be it in the U.S., Europe, or globally?

$10 million to $15 million for upfront ish too.

Necessary patients enrolled as Jared cited earlier in order for us to receive and answer from from our friends at the FDA, We felt as if we would be in a much better position.

With both of those and so we kind of over.

The early part of the year here in middle part of the year really slow played our discussions.

So allowed a handful of other companies to kind of get up to speed on their third diligence. So we have a number of companies all in and around the same spot in terms of their understanding.

Where we currently sit certainly from a regulatory perspective and also quite frankly, the latest data that we've mined from our clinical trial is also very very supportive of our regulatory approach. So Jared has been overseeing and has done a great job in terms of.

<unk> on the corporate development side, and making certain that we were in a position of strength.

Hi, Jeff. Thank you for the question. Much appreciated, hope you're doing well on your end. Obviously when, you know, we anticipated a positive um, outcome with our friends across the pond and um, you know, did the necessary uh, work on the costs associated with our clinical trial, our confirmatory study for the US, it became apparent um, to us to to slow play. Um, corporate development discussions until we had, you know, the blessing certainly from the EMA on our capacity to file, obviously that becomes now hypocrisy and is a near-term oncology asset in a very robust xus Market at a minimum. Um, and then when we also, uh, based on our further Communications, with the FDA, we're able to really drill down in terms of line of sight and, and this, you know, 10 to 15 million dollars.

To optimize the potential value for our stockholders with IRA focusing on a number of different fronts and I'll turn this over to him.

To provide some additional detail Joey.

Sure.

Such that Greg talked to you.

But I'll confess that I am not sure I can add much more detail Jim did a great job there explaining exactly where we sit.

I would say that we.

We.

Obviously, as you get closer and closer to a regulatory approval the interest and activity picks up.

Especially when you start to be able to reposition this sort of as we just talked about with aided with it with the competition.

Conditional market approval in Europe.

Potential to negotiate from a position of strength on pricing through the H D a process.

Uh, for upfront is to um the necessary patients enrolled as Jared cited earlier in order for us to to receive um an answer from from our friends at the FDA we felt as if we would be in a much better position, um, with both of those. And so we kind of over the, you know, the early part of the Year here, in middle part of the year, really slow played our discussions. Um, it also allowed a handful of other companies to kind of get up to speed on their their diligence. So we have a number of companies all in in and around the same spot in terms of their understanding of, uh, you know, where we currently sit certainly from a regulatory perspective, and also quite frankly, um, the latest data that we've mined from our, our clinical trial is also very, very supportive of of our regulatory approach sub Jared has been overseeing and has done a great job. Um, in terms of communication on the corporate development side and making certain that we were in a position of strength.

The potential to the potential in our approach to manufacturing cost of goods all of those things puts us in a very positive light with most with various.

<unk> opportunities and so we've seen agents at.

Um, you know, to optimize the potential value for our stockholders with opposing on a number of different fronts and I'll turn this over to him. Um, you know, to provide some additional detail Jared.

An increase in that I think the second part of your question, which Mike.

I can dig into a little bit more which is the strategy.

We've talked about this before and we continue to be in this situation, we have ongoing discussions with parties.

Sure. And I I, I prefer stress, it's great to talk to you, uh, but I'll confess that, I'm not sure that I can add much more detail. Jim did a great job there. Uh, explaining, you know, exactly where we sit. Uh, I would say that we, you know,

I would say are are either globally focused or are.

Focus on the two predominant regions right now put radio farm, which is the U S and Europe.

Do have various regional conversations ongoing that are advancing rapidly.

So those are those might be.

Part of those territories or all of those are for US said in other ways.

So the Europe could be.

So the U S. The other territories outside of that but.

obviously as you get closer and closer to a regulatory approval, the interest and activity heats up. Uh especially when you start to be able to be position this and sort of, as we just talked about with Aiden, with the with the potential, you know, conditional Market approval in your the potential to negotiate from a position of strength on pricing through the HTA process.

As Jim alluded to we have quite a number of parties right now.

Who have either completed or nearly completed their diligence who have.

Supplied and move forward into the next phases of partnering.

And we continue to try to drive that.

They can they the potential to, you know, the potential, and our approach to manufacturer, and cost of goods. All of those things puts us in a very positive light when most with various partners and opportunities. And so, we've seen patients that an increase in that. I think the second part of your question, which might

Maximize both the return for the organization and to ensure as Jim said in his opening remarks ensure that the drug is developed in such a way that it does get the patient actually benefit.

Great really appreciate it.

Uh, I can dig into a little bit more which is the, the, the strategy. You know, I think we talked about this before and we continue to be in this situation we have ongoing discussions with parties who I would say, are, are either globally focused or are

And apologies if I missed this on the call.

With respect to 225 and the pancreatic program I know you are moving you are actively moving 125 ahead in that trial is taking off.

Focused on the 2-minute Regents right now, for radio Farm, which is the US and Europe. Uh, we do have various Regional conversations ongoing that are advancing rapidly.

Any gating items on Q2 five to begin that trial.

Is that something you would move ahead with the absent additional financing or.

Is that one pending.

Okay.

Yes, I believe the team Jeff.

<unk> has put us on the precipice of phase one.

So those are, you know, those might be part of those territories or all of those territories set in other ways, it could be, you know, solely Europe. Could be solely, us could be other territories outside of that. But uh, as Jim alluded to, we have quite a number of parties right now, uh, who have either completed or nearly completed due diligence who have, uh, supplied and, and moved forward into the next phases of partnering. Uh, and we continue to try to drive that.

<unk> study there with.

What the pancreatic cancelled two five.

It is a function essentially of financing as the gating issue there Jarrett any additional color to provide.

Maximize both the return for the organization and to ensure at June 77 is opening remarks ensure that the drug is developed in such a way that it does get the patient actually benefit.

Okay.

I would agree with you I think quite happy to see getting getting element and as Jim said, we are we currently sit in a position.

Two essentially initiate the study as soon as the capital is in hand, so to speak.

We have the CRO, we have the submissions we have sites, we have everything ready to run.

On the call, um, with respect to 225 and the pancreatic program I know you're moving, you're actively moving, 125 ahead and that trial is taking off. Um,

For that study.

As you can see part of the reason, we have announced the various supply agreements is because.

Particularly around actinium is because with what we've done is make sure that we have a system.

Any gating items on 225 to begin that trial? Or is that something you would move ahead with the absent additional financing? Or um, is that 1 pending

Supply of act any answer that we are not related in any way shape or form as it relates to that any in sourcing and that supply gets us from where we sit today based off our forecasting all the way through into commercialization on the team.

Pain program.

That's exactly why we've done that since there are no hiccups or delays on that front as we've seen with other parties and so we expect.

Yep, I believe the team Jeff um you know, has put us on the precipice of a a phase 1. Uh ready study there with uh with the pancreatic cancer 325. Um it is a function essentially of financing as the gating issue there. Jared any additional color if you'd like to provide

Again pending the capital we expect to initiate that phase one and I will call phase. One study is it really is a dose escalation safety study.

With the dosimetry components. So at the end of the day, what we'd be looking at is clear safety and understanding of the uptake and distribution of the molecule, which we don't expect to be very different than what we've seen historically.

Got it great.

Hey.

No, I I would agree with you, I think that Finance to see getting getting element and as Jim said, we are we currently set in a position uh to essentially initiate the study as soon as the capital is is in hand so to speak. Uh we have the cro, we have the submissions, we have sites, we have everything ready to run uh for that study. Uh and as you can see, part of the reason we have announced the various Supply agreements is because

No I'm, sorry, I was just going to make a comment.

No worries. So I was just going to make a comment on how significant we view the triplet.

Particularly around octanium is because if we've done is make sure that we have a consistent.

As an example to triple negative breast cancer study.

Solid tumor as Jared cited we believe our drug conjugate will behave.

Supply of actinium so that we are not delayed in any way, shape, or form as it relates to actinium sourcing. And that Supply, gets us from where we sit today, based off our forecasting, all the way through into commercialization on the, uh,

program.

In a very similar manner to what we've observed with other isotopes as well.

241 to five.

As well as 131.

And so this is really I think for the company and for validation of our platform very significant and as Jared perhaps you could just expand a little bit for our audience.

The imaging and dosimetry data that we expect to collect very early on in this study.

We believe we will be further validating our platform and in particular, our capacity to be very effective and challenging solid tumors.

And that's, that's exactly why we've done that. Since there are no hiccups or delays on that front as we've seen with other parties. And so we we expect you know again it's depending the capital. We expect to initiate that Phase 1 and I'll call Phase 1 a study. It's a really it is a dose escalation safety study uh with the dose symmetry component. So at the end of the day, what we'd be looking at is you know, clear safety and understanding of the uptake and distribution of the molecule which we don't expect to be very different than what we've seen historically.

Got it grid appreciated.

Sure.

Yeah.

So we're not going.

Blend is because it's the same whether I'm talking about the actinium program in pancreatic cancer with <unk>.

225, or the triple negative breast cancer program with CLR one to five.

In both cases, we're utilizing dosimetry.

For folks that may not be as familiar with.

The radiopharmaceutical radiotherapy targeted radiotherapeutic strategies here benefited the cemetery is unlike other therapies, where we take blood samples and we use that to sort of calculate a guesstimate the amount of uptake into the tumor and there also into other healthy tissues.

No. Sorry I was just going to make a comment. Uh, no worries. I was just going to make a comment on how significant we view the trip. You know, as an example, the triple negative breast cancer study, um it's solid tumor um as Jared cited we believe our drug our our conjugate will behave in a very similar manner to what we've observed with other Isotopes as well. 124 125, um, you know, as well as 131. And so this is really I think for

In this case, what we're able to do was actually image.

The transit of the drug with inside the human body, and we're able to identify exactly where it is at different time points utilizing that data.

Then able to calculate both the absorbed dose.

The company and for validation of our platform very significant and as and Jared perhaps you could just expand a little bit for our audience on the Imaging and do symmetry data that we, you know, expect to collect very early on in this study. Um, that we believe will be, you know, further validating of our platform and in particular, our capacity to be very effective in a challenging solid tumors.

The healthy tissue and be able to know when we might achieve a level that would be toxic and on the other side, we're able to calculate the absorbed dose into the tumor and thereby calculate the expected dose and dosing regimen necessary to be an active therapy.

Sure. Uh, and and, and so, we're, we're, I'm going to blend this because it's the same. Whether I'm talking about the actinium program and pancreatic cancer with

In that tumor type.

And utilizing that data you could get what's called a therapeutic window and you get the opportunity.

And, you know, Seal 2225 or the triple negative breast cancer program with CLR 125, in both cases, we're utilizing those symmetry. And for folks that may not be as familiar with the...

That is the difference between your therapeutic dose therapy dose and when do you start to see toxicity and we expect as we've seen with our policy.

This therapeutic window will be significantly wide enough interestingly enough in the CLR too high program back.

Thats the piece for a moment one of the great challenges in pancreatic cancer is not just the nature of the tumor and the late stage with patients who are diagnosed but it's also there is a what they call interstitial pressure in the tumor which prevents most drugs from actually being able to penetrate the tumor because there's fluid pressure pushing back.

The radio pharmaceutical radio therapeutic targeted radio therapeutic strategies here, the benefit of cemetery is unlike other therapies where we take blood samples and we use that to sort of calculate and guesstimate the amount of uptake in into the tumor and they are also into other healthy issues. In this case, what we're able to do is actually image in the, the the transit of the drug with inside the human body. And we're able to identify exactly where it is at different time points, utilizing that data, we're then able to calculate both the absorbed dose in, in the healthy tissue and be able to know.

Against.

Interestingly enough as what we saw when we did this in the animal studies. Our phospholipid ether is again gives us a unique ability to actually penetrate screw that and actually get inside the tumor deep inside the tumor which is one of the reasons why we think.

When we might achieve a level that would be their toxic. On the other side, we're able to calculate the absorbed dose into the tumor, and thereby calculate the expected dose and dosing regimen necessary to be an active therapy in that tumor type.

Particularly in pancreatic cancer, we have a competitive advantage over other programs that tumor specific obviously in triple negative breast cancer with the <unk>, but we've seen similar sort of results, but that comes at it from a different perspective, particularly because you have limited targets now in breast cancer and being able to overcome that.

With our targeted mechanism that is based off of medical need.

Okay.

Greatly appreciate it thank you Darren.

Yeah.

As a reminder for any further questions. Since you have a question. Please press the star followed by the one at this time, we will share a prompt acknowledging that your hand has been raised and should you wish to withdraw your request. Please press the star followed by the team.

Our next question comes from Jonathan Aschoff IRA.

Go ahead.

Hi, guys. Good morning, Congrats on the regulatory progress I was curious just because the full approval based on PFS can you remind us where you are in.

Clover Wm follow up and where that PSS PFS last came out or at least or at least what it at least is.

As as we have seen with ipog, that this therapeutic window will be significantly wide enough. Interestingly enough in the CLR 25 program back to the pancreatic with a piece for a moment, 1 of the great challenges in, pancreatic cancer is not just the nature of the tumor and the late stage, which patients have diagnosed. But it's also, there is a, what they call interstitial pressure in the tumor which prevents most drugs from actually being able to penetrate the tumor because there's fluid pressure, pushing back against anything entry. Interestingly enough as what we saw it when we did this, in the animal studies, our phospholipid ethers. Again, give us a unique ability to actually penetrate through that and actually get inside the tumor and get deep inside the tumor, which is 1 of the reasons. Why we think, uh, particularly in pancreatic cancer, we have a competitive advantage over other programs in that tumor specifically in triple negative breast cancer with the iclr 125. We've seen similar sort of

And how that compares to standard of care for Wm.

Of course, Jonathan Thanks for your participation we have not updated.

Results. But that comes at it from a different perspective, particularly because you have limited targets now in breast cancer, uh, and being able to overcome that with our targeting mechanisms that is based off of metabolic needs.

Our data since January of last year relative to PFS.

Greatly appreciate it. Thank you, Jared.

And at that point in time, it was very robust and well beyond what you normally would see with salvage therapies into lines of therapy that we were treating.

So Jared if you want to provide some detail there I think it would be helpful for Jonathan and our audience.

Reminder, if there are any further questions, should you have a question at all? Please press the star followed by the 1. At this time, you will hear a prompt acknowledging that your hand has been raised, and should you wish to withdraw your request, please press the star, followed, by the 2.

Yes Jared.

I had 11 four months after eight months, but you last said, yes follow up beyond 12 months.

Our next question comes from Jonathan, aschoff by Ross, please go ahead.

We can get any further PFS without additional follow up some kind of just kind of reconcile where it is.

Yeah, absolutely. Thank you. Thank you for confirming what I was about to say.

I was about to say.

It wasn't 11 four months with eight months of follow up we now have 12 months of follow up on all patients that is correct that is.

Uh, hi guys. Good morning. It's congrats on the regulatory progress. Um, I was curious just because, um, full approval is based on PFS. Can you remind us where you are in Clover? WM follow up and where that PF is. PFS last came out, or at least, or at least what it at least is. Um, and uh, how that compares to standard of care for WM

That was one of the criteria that the FDA for submission for accelerated approval have requested we now have that as you might as Im sure you are aware.

Basically where we are in the process, we have not announced additional data.

Do not wish.

We're not in a position how long, let's say you do not wish were not in a position to announce additional data at this juncture largely in part because we are now in a process of trying to submit this or FDA regulation and we don't want to be caught in a situation where the FDA may view us as the promotional as it relates to this data prior to a submission so at this juncture.

Of course, Jonathan thanks for your participation. We have not updated, um our data since January of last year relative to to PFS. Um and at that point in time, it was very robust and well beyond what you'd normally would see, with Salvage therapies and the lines of therapy that we were treating.

So Jared, if you want to provide some detail there, I think it would be helpful for Jonathan and our audience.

The most recent data is that data from January of last year and that won't be updated.

Uh, yeah, Jared before you do that, I had 11.4 months after 8 months but you last said you had follow-up Beyond 12 months. I just didn't get any further PFS with that additional follow-up. So I'm kind of just trying to reconcile where it is.

In the near term.

Yeah, absolutely. And thank you. Thank you for confirming. What I was about to say to you.

Alright.

And I'll say in the near term.

Based off of the requirements.

Discussions with.

Okay.

The way the order for pancreatic is filed the IMD get funding to start the trial correct.

Sort of so Patrick.

Jim if I jumped in there too fast.

The pancreatic cancer.

Study is one that we're not running in the U S. So it will be finally, and we have filed ex U S with the appropriate authority.

To execute the study and have that already so we're in a position now where it is await the capital and then initiate this time.

Excellent. Thank you guys.

Uh, what I was about to say is we, it was 11.4 months with 8 months to follow up. We now have 12 months to follow up on all patients. That is correct. That is a per, you know, that was 1 of the criteria that the FDA or submission for Accelerated with Google had requested. We now have that as you might under, as I'm sure you were aware, you know, basically where we are in the process, we have not announced additional data. Uh, we do not wish, we were not in a position. I only want to say, we do not wish, we're not in a position to announce an additional data at this juncture largely in part because we are now in a process of trying to submit this for FDA regulation and we don't want to be caught in a situation where the FDA May view us as being promotional as it relates to this data prior to a submission. So at this juncture,

Nowhere is the only.

Additional information that I will provide.

The most recent data is that data from January of last year and that won't be updated uh in the near term.

In regards to the PFS question, Jonathan is that when we did multiple.

Advisory boards with global thought leadership.

Uh, or you know, and I'll say in the near term, based off of the requirements in discussions with...

Before world is strong as macro globule, EMEA and what came across very very clearly within the patient population.

Okay. Um and by the way, the order for pancreatic is filed the IND, get funding, start the trial correct?

For all participants this was I appropriately being used essentially as fifth line therapy.

Uh sort of so practically, sorry, Jim, if I if I jumped in there too fast. Uh the uh the the pancreatic cancer.

For this patient population.

Don.

The response rate that we achieved was that 60% range was considered outstanding and more importantly.

They gave us insight that four to six months of PFS for that patient population would be an excellent outcome and as as you cited yourself with our initial cut of data. We're at approximately one year of PFS. So.

Study is 1 that we're not running in the US so it will be filing and we have filed uh xus with the appropriate authority to execute the study and have that accepted already. So we're in a position now where it is awake the capital and then initiate this stuff.

Excellent. Thank you guys.

Almost doubling.

Or or greater the.

The expectation of thought leadership and Wm in terms of what would be considered an excellent result for patients.

Okay. There are no further questions at this time I will now turn the call over to Jim Caruso. Please continue.

Terrific. Thank you operator. This concludes our call for today certainly appreciate the great questions from our analysts and for your participation.

As well as all participants of course this will be.

Up on our website and a transcript will be following this call. Thank you all very much.

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

Then is that, when we did multiple, um, advisory boards with, you know, Global thought leadership, um, before Walden Strong's, macro globular and what came across very, very clearly was in the patient population and and just for all participants. Um, this was, you know, I apologizing being used, essentially, as Fifth Line therapy, um, for this patient population 1. Um, you know, the response rate that we achieved was, you know, that 60% range was considered outstanding and more importantly, they they gave us Insight that 4 to 6 months of PFS for that patient, population would be an excellent outcome. And, you know as as you cite it yourself. Um, with our initial cut of data, we're at approximately 1 year of PFS so um, almost doubling or, or or or, or greater, um, the expectation of

of thought leadership in WM, in terms of what would be considered, you know, an excellent result for patients,

Okay, there are no further questions at this time. I will now turn the call over to Jim Caruso. Please continue

Terrific. Thank you, operator. This concludes our call for today, certainly appreciate uh the great questions from our analysts and and for your participation uh, as well as you know, all participants. Um, of course this will be, um, up on our website and a transcript will be following this call. Thank you all very much.

ladies and gentlemen, this concludes today's

conference call. Thank you for your participation. You may now disconnect