Cellectar Biosciences, Inc. (NASDAQ:CLRB) Q4 2024 Earnings Call Transcript

Cellectar Biosciences, Inc. (NASDAQ:CLRB) Q4 2024 Earnings Call Transcript March 13, 2025

Cellectar Biosciences, Inc. beats earnings expectations. Reported EPS is $-0.06, expectations were $-0.38.

Operator: Ladies and gentlemen, thank you for standing by, and welcome. At this time all participants are in listen-only mode. Following the presentation, there will be a question-and-answer session. Please be advised that today’s conference call may be recorded. I would now like to hand the conference call over to Anne Marie Fields, Managing Director at Precision AQ. Please go ahead.

Anne Marie Fields: Thank you operator. Good morning, and welcome to Cellectar Biosciences’ Fourth Quarter and Full Year 2024 Financial Results and Business Update Conference Call. Joining us today from Cellectar are Jim Caruso, President and CEO, who will provide an overview of the company’s progress; before turning the call over to Chad Kolean, CFO, for a financial review of the quarter and the year. Following this, Jarrod Longcor, Chief Operating Officer, will give an update on the company’s progress and plans for its promising clinical development pipeline of radiopharmaceuticals. Cellectar issued a press release earlier this morning detailing the content of today’s call. A copy can be found on the Investor page of Cellectar’s corporate website.

I want to remind callers that the information discussed on the call today is covered under the safe harbor provisions of the Private Securities Litigation Reform Act. I caution listeners that management will be making forward-looking statements. Actual results could differ materially from those stated or implied by our forward-looking statements due to risks and uncertainties associated with the business. These forward-looking statements are qualified in their entirety by the cautionary statements contained in today’s press release and in our SEC filings. The content of this conference call contains time-sensitive information that’s accurate only as of the date of this live broadcast, March 13, 2025. The company undertakes no obligation to revise or update any forward-looking statements to reflect events or circumstances after the date of this conference call and webcast.

As a reminder, this conference call and webcast are being recorded and archived. We will begin the call with prepared remarks, and then open the line for your questions. I’ll now turn the call over to Jim Caruso. Jim?

Jim Caruso: Thank you, Anne Marie, and thank you to all for joining us this morning as we share Cellectar’s recent regulatory progress with iopofosine, our ongoing preparations to advance our Alpha and Auger radioisotopes solid tumor programs, and forward-looking plans to address the Company’s NASDAQ status and future funding including evaluation of non-dilutive funding opportunities. 2024 can be described as a bittersweet year for Cellectar, starting with the announcement of excellent clinical results from our CLOVER-WaM study of iapopacine I131 for the treatment of relapsed/refractory Waldenstrom’s macroglobulinemia, or WN, and concluding with disappointing regulatory news, which delays the submission of the new drug application, or NDA, for conditional approval under the accelerated approval process.

In the CLOVER-WaM study, iapopacine demonstrated an impressive 98.2% clinical benefit rate, 83.6% overall response rate and a major response rate of 58.2%. These clinical outcomes are particularly meaningful for this challenging to treat relapsed/refractory elderly patient population. For these patients, limited reduction in tumor burden or achievement of disease stability can provide clinical benefit with improved symptoms and extended progression free-survival and time to next treatment. We remain confident in the potential value iapopacine will provide to patients suffering from this incurable disease. Unfortunately, we experienced a regulatory setback with our plans to file an NDA in the first half of 2025, which adversely impacted our stock price towards the end of last year.

As the clinical data demonstrates, iapopacine offers potential to be a meaningful treatment for all relapsed/refractory WM patients. As such, in alignment with the FDA, we recrafted the path to market through the accelerated approval process pathway. Our comprehensive product market research, market sizing and commercial analysis underscores iapopacine’s significant market potential in the relapsed/refractory setting. This potential is driven by iapopacine’s novel mechanism of action, its distinctive product profile and size of the relapsed/refractory marker. In addition to clinical benefits and the product profile, other key attributes include a fixed dosing regimen, a unique 17-day shelf-life, orphan drug pricing and its ability to address a high unmet, clinical need in a landscape with limited approved treatment options.

These factors collectively position iopofosine as a promising therapeutic candidate in this challenging market segment and Cellectar remains committed to bringing this potential potentially, life-saving drug to patients likely to benefit from this treatment. To this end, we recently held a very productive meeting with the FDA to finalize the regulatory pathway for iopofosine and WM. I am pleased to share that we have achieved alignment on the design of a Phase 3 study required for market approval. Later in this call, Jarrod will discuss the study design, the cost efficiency and projected timelines to advance iopofosine toward commercialization. Given the strong enthusiasm surrounding iopofosine among patients, key opinion leaders in WM and the broader healthcare community, we are confident that the study will achieve rapid enrollment.

This momentum underscores the high level of interest in iopofosine as a potential therapy for this challenging disease and reflects its significant promise in addressing unmet clinical needs. Based upon the quality of the CLOVER-WaM data, limited perceived clinical risk to approval and a robust global market opportunity, we continue to evaluate inbound inquiries regarding a range of collaborations and licensing deals which is our preferred non-dilutive funding approach. In addition to our late-stage iopofosine program at WM, we remain bullish on our solid tumor-focused radioisotope programs which include our alpha emitter for pancreatic cancer and the Auger emitter for evaluation in triple negative breast cancer, both of which highlight the novel utility of our delivery platform.

As mentioned earlier, the delay in our NDA submission for iopofosine adversely impacted the company’s stock and market capitalization. We believe we can organically increase our stock price to satisfy the NASDAQ requirement based upon driving milestones such as regulatory clarity for iopofosine WM, acquisition of non-dilutive funding, technology validation through third-party collaborations and progress with our Phase 1 ready radioisotope assets, along with the removal of any perceived financial overhead. Now let me turn the call over to Chad for additional color on this topic and a detailed review of our financial results. Chad?

Chad Kolean: Thank you, Jim. In 2024 we executed multiple financial transactions that strengthened Cellectar’s balance sheet, including investors exercise a warrant in January generating $44.1 million and an inducement financing in July which included the exercise of existing warrants and the purchase of new warrants for $19.4 million in proceeds. As we communicated last October, we refiled our historical financial statements for fiscal years 2023 and 2022, an action that was precipitated by a re-evaluation of the accounting for warrants issued prior to 2023. As a reminder at the time of issuance, the warrants were classified as equity-based upon internal and external assessment. As supported by our existing accounting firm at that time and a global professional services firm, which provided an expert third party evaluation, a subsequent internal review determined that these warrants should have been classified as liabilities, which necessitated the revision to our historical reporting.

Importantly, the restatement had no impact on historical cash or cash burn reported and the changes to earnings were all non-operating and non-cash. Now turning to our financial results in the fourth quarter and full year ended December 31, 2024, we ended the year with cash and cash equivalents of $23.3 million, as compared to $9.6 million as of December 31, 2023. Based upon the delay in iopofosine’s NDA submission and lack of regulatory clarity, we implemented a cost savings strategic restructuring which reduced headcount by approximately 60%, we expect restructuring to drive savings of approximately $7.5 million annually and to extend our cash runway into the fourth quarter of 2025. Moving to the operating results, research and development expenses for the full year 2024 were approximately $26.1 million compared with $27.3 million in the prior year.

The decrease was largely driven by the timing of expenditures for our WM Phase 2 study to support patient enrollment and follow-up visits and was partially offset by the extensive analytical work necessary to prepare for a plan NDA submission. Product sourcing and expansion of manufacturing and logistics infrastructure costs to support multi-sourcing each aspect of iopofosine I 131 production. Selling, general and administrative expenses for the full year 2024 were $25.6 million compared to $11.7 million in the prior year. These incremental investments were largely due to pre-commercialization initiatives such as product related qualitative and quantitative market research, market sizing, competitive landscape, product pricing research, patient support programming, third-party payer work, wholesaler distribution and channel development.

This research and analytical work product further validated the substantial WM market opportunity for iopofosine, enhancing the value of iopofosine and supporting our funding efforts and potential collaborations with prospective partners. Other income and expense net was approximately $7.4 million of income in 2024 as compared to approximately $3.9 million of expense in the prior year. These amounts are almost exclusively non-cash and are driven by the issuance and valuation of equity securities in conjunction with our financing activities. The only component of this category impact cash is interest income which for the year just ended improved to approximately $1.2 million from $0.4 million in 2023. Net loss for the full year ended December 31, 2024 was $44.6 million or $1.22 per basic share and $1.40 per fully diluted share compared to $42.8 million or $3.50 per basic and fully diluted share during 2023.

Addressing our compliance with the continued listing requirements for NASDAQ, as Jim noted in his opening remarks, we are engaged on a broad variety of fronts to further strengthen the balance sheet and enhance the valuation of the company. NASDAQ provides an initial 180-day remediation period [indiscernible]. NASDAQ also maintains the right to grant an additional 180-day remediation period upon request provided the company meets all other listed criteria. If necessary, we will request an additional 180-day remediation period. In addition to create corporate optionality, we will ask our stockholders to approve a possible reverse stock split as part of our June 2025 annual meeting. Of course, a reverse split would only be implemented if all other initiatives have been exhausted and it is deemed absolutely necessary to do so.

We believe this multifaceted approach enables the company’s ability to maintain optionality and deliver the best available outcome for all constituencies. I will now turn the call over to Jarrod for an operational update, including plans for our promising pipeline of radiopharmaceuticals.

Jarrod Longcor: Thank you, Chad and good morning, everyone. I will begin by providing a regulatory update on iopofosine for the treatment of WM. Following our November 2024 FDA meeting, we sought to obtain additional clarity on the agency’s preferred study design to support an accelerated approval. We formally submitted an end of Phase 2 meeting request in early January, providing a study protocol designed to align with the FDA’s clinical development feedback. The formal meeting was held on March 6 and I am pleased to report that we successfully achieved a crucial milestone for the future development of iopofosine I 131, establishing a clear regulatory pathway for our promising drug. We view the outcome as a significant win and believe it sets a clear path to the NDA submission and market approval for iopofosine in WM patients.

The path requires the completion of a confirmatory randomized controlled study of iopofosine I 131 versus a comparator arm, which will provide the study investigators a choice between one of two NCCN approved treatment options. This trial is expected to enroll approximately 100 patients per arm. Both the FDA and Cellectar have agreed upon the major protocol elements and the requirements for accelerated and full approval. The approval process is anticipated to proceed in two stages. The additional accelerated approval is based upon major response rate. Subsequently, full approval is contingent upon achieving progression-free survival. We anticipate that the study to enroll – will enroll rapidly and to achieve full enrollment within approximately 24 months of the first patient treatment.

The total cost is between $40 million and $45 million. We estimate that approximately $30 million will be required to achieve full enrollment, which facilitates the NDA submission for conditional approval. The approximately $15 million balance remaining would be required for the determination of PFS, long-term follow-up, and study closure. This approach aligns with FDA guidance and provides a well defined path to potentially bring iopofosine I 131 to market for the treatment of relapsed/refractory WM patients in the U.S. We are also seeking to reach similar alignment with the EMA or European Medical Agency to harmonize the study designed for market approval in both the U.S. and Europe. We expect to be ready to initiate this study later this year.

In addition to these activities, Cellectar is employing our proprietary Phospholipid Drug Conjugate or PDC tumor targeting delivery platform to develop unique and potentially game changing cancer treatments. Our PDCs possess the potential to deliver improved efficacy and better safety resulting from improved targeting of various oncology payloads to the tumor. Iopofosine clearly provides clinical proof of concept for the platform with the targeted delivery of a radioisotope. Based upon this validation, we have developed a broad proprietary pipeline that includes other targeted radioisotopes, small molecules, peptides and oligonucleotides, each of which has been validated in vitro and in vivo. The modular nature of the platform has allowed us to rapidly and iteratively test and evaluate most therapeutic radioisotopes across the different classes of emitter types.

This provides the unique ability to more effectively select the right isotope for the right tumor. We accomplish this by taking advantage of our near uniform targeted delivery to allow for the rapid and simultaneous testing of various isotopes in the same in vivo models. Our approach results in a comparative assessment of the tolerability and activity of each isotope in each type of cancer. While most radioisotope development companies focus on varying the targeting element to improve activity, this does not account for the impact of the isotope selection. Our technology allows the optimization of both essential elements and has demonstrated in vivo differential benefit between isotopes for specific tumor types. I will now review two of our exciting early stage radio conjugates.

The first is our alpha emitting actinium based compound CLR 121225 and the second is CLR 121125, our lead Auger emitter. CLR 121225 is our lead alpha-emitting conjugate product candidate that has shown excellent biodistribution and uptake in the tumors, exhibiting activity across multiple solid tumor animal models, including challenging to treat pancreatic ductal adenocarcinoma and colorectal cancers. Importantly, in all tumor types tested, CLR 121225 has been shown to be safe and well tolerated. Like iopofosine, we have established a network of isotope and finished products CDMOs to guarantee sufficient supply in the near and long-term for the full development of CLR 121225. We continue to evaluate additional CDMOs to ensure capacity for indication expansion and long-term risk mitigation.

The Phase 1 trial for CLR 121225 is designed to be comprehensively evaluate the compound’s biodistribution, safety and tolerability in patients with pancreatic adenocarcinoma. The study will commence with a dosimetry phase aimed at determining the absorbed dose in both normal and tumor tissue. This initial assessment will provide valuable insights into the compound’s biodistribution and potential therapeutic window laying the foundation for subsequent phases of the trial and future development. Following dosimetry, the study will progress to a dose escalation phase systematically evaluating increasing doses of CLR 121225 to establish the maximum tolerated dose. This carefully structured approach offers an opportunity to demonstrate proof-of-concept of our innovative combination of phospholipid ether or PLE technology with alpha emitters, potentially showcasing this radio-conjugate’s unique ability to safely treat large bulky solid tumors.

The significance of this trial extends beyond its immediate objective. Positive outcomes in this notoriously challenging tumor type could represent a paradigm shift in cancer treatment approaches. We believe that valuable data from this study could be transformative for Cellectar, potentially opening new avenues for targeted radiotherapeutics and rapidly advancing our position to the forefront of cancer treatment innovation. We will be prepared to initiate this study in the first half of 2025. Auger-emitting isotopes represent the pinnacle of precision in targeted radiotherapy with emissions traveling only a few nanometers. This ultra short range necessitates delivery of the isotope in close proximity to the cellular DNA to achieve therapeutic activity.

Our proprietary PDC platform uniquely enables intracellular delivery and facilitates the necessary targeted delivery at the subcellular level, setting CLR 121225 apart in the landscape of radiopharmaceuticals and potentially offering a new paradigm in targeted cancer therapy. We are strategically positioned to advance CLR 121225, our lead Auger emitter using iodine-125 as radio-conjugate product into the next stage of development. The activity of CLR 121225’s intracellular delivery mechanism has been rigorously validated through preclinical studies. These investigations have demonstrated significant tumor uptake across multiple animal models, resulting in promising activity and tolerability profiles even in notoriously challenging tumor types such as triple negative breast cancer and metastatic breast cancer.

Similar to CLR 121225, we are preparing CLR 121225 for a Phase 1b study in triple negative breast cancer. This trial will evaluate three distinct doses and dosing regimens with the primary objective of identifying the optimal recommended Phase 2 dose. The study will include an imaging component to further elucidate the biodistribution of CLR 121125, providing crucial insights into its targeting and potential efficacy. By focusing on triple negative breast cancer, we are targeting an aggressive and difficult to treat subtype of breast cancer, underscoring our commitment to addressing high unmet medical needs. The strategic decision to pursue this indication aligns with our broader mission develop innovative therapies for challenging delinquencies.

Success in this area could be particularly impactful given the limited treatment options currently available for triple negative breast cancer patients. We anticipate that positive data from this study could significantly enhance the value proposition of CLR 121125 and by extension, our entire radiopharmaceutical platform. These trials represent a critical step in our pipeline development, potentially positioning both CLR 121225 and CLR 121125 as groundbreaking therapies in the evolving landscape of targeted radiopharmaceuticals for cancer treatment. Furthermore, these programs showcase the versatility of our platform and reinforces our commitment to developing innovative, highly targeted treatments that could significantly improve outcomes for patients.

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

Jim Caruso: Thank you, Jarrod. As you can see, we are off to a very good start in 2025 by rapidly securing clarity on the FDA’s requirements for a conditional approval under the accelerated approval pathway. To state the obvious, this is a significant achievement and asset value enhancer. As I previously reported, we are in advanced discussions with multiple companies regarding the licensing rights for iopofosine. The regulatory strategy established with the FDA provides a clear and cost efficient regulatory pathway forward for iopofosine with what we believe to be limited clinical and execution risk. In essence, the regulatory clarity has significantly enhanced the value of iopofosine. Non-dilutive cash associated with these potential deals would be highly beneficial for the company.

In addition, we will be prepared to initiate Phase 1 studies for both the alpha actinium-based radioconjugate in pancreatic cancer and the Auger-emitter for triple negative breast cancer in the first half of 2025. The initiation of these respective studies are to be determined. Our current cash position extends into the fourth quarter of 2025, which we believe provides ample time to evaluate and advance non-dilutive licensing deals and potential funding vehicles and in parallel assess time for the initiation of our Phase 1 assets. Before opening the call to your questions, I would like to thank our dedicated and talented Cellectar team who continue to work with tremendous determination to move these important programs and the company forward.

We remain committed to the WM community and sincerely appreciate the abundance of support and continued encouragement to advance iopofosine to market. Together, we continue to push the boundaries of what is possible in oncology and we look forward to the future with optimism and hopes. Operator, we are ready to open the call to questions.

Q&A Session

Operator: Thank you. Ladies and gentlemen, we will now conduct a question-and-answer session. [Operator Instructions] Our first question comes from the line of Jeff Jones from Oppenheimer. Your line is open.

Unidentified Analyst: Hi, thanks for the update. This is Shiny [ph] on for Jeff. A clarity question for NDA is acceptance for iopofosine I 131. Does the NDA section require the NR data from the confirmatory study or just the CLOVER-WaM? And I have follow up. Thanks.

Jim Caruso: Sorry, let me you were breaking up there pretty bad. So I’m not 100% sure I captured everything that to you are trying question. Was the question for the NDA submission, does it require data from the new from a new study or is it just from the CLOVER-WaM study?

Unidentified Analyst: Yes, I mean the NDA acceptance require the MRR data from the confirmatory study or just the CLOVER study?

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

Unidentified Analyst: Gotcha. Thanks. So can you share the timeline for patients to achieve and be evaluated for an MRR response under the [indiscernible] study design?

Jim Caruso: Certainly. Hi, this is, Jim. Before I turn that question over to Jarrod. We do anticipate rapid enrollment in this study based on our obviously the drug’s performance in the Phase 2 where we achieved outstanding clinical results and quite frankly a very impressive adverse event profile as well. WM community was very disappointed that there would be a delay to market for iopofosine. There’s clearly high unmet medical need there and the patients have really reached out and have rallied around this drug and the company and we’re very appreciative of that. In addition, the thought leadership also disappointed that they’re not going to have this drug available in the very near term for their patients. Having said that, it’s very clear that the healthcare community would rally around the clinical study and we expect enrollment quite frankly very quickly.

And from first patient in we’ve crafted some time and events that we believe are conservative. And I’ll turn this over to Jarrod to provide some detail around this.

Jarrod Longcor: Yes, as Jim said, we took a conservative sort of approach to building our timelines here. And from that perspective we look at it from first patient enrolled, aka first patient dose that it would be approximately 24 months to full enrollment and then with the two major response rate being approximately 30 days that it would basically be one more month to achieve the necessary outcomes for major response rate.

Unidentified Analyst: Great, very helpful, thank you. And what would be the comparator be or any color on the comparator? Thanks.

Jarrod Longcor: We’re particularly excited about, how we’ve crafted this with the FDA and the FDA support in terms of the comparator arm. And this is one of the reasons why we believe we have and our thought leaders and advisory council believe we have very limited clinical risk here. Jarrod?

Jarrod Longcor: Yes. I would add to that. We believe or we know that at least one of the comparators, as we mentioned it will be two comparators. It’s investigator choice study design. So they get instead of one of the nine NCCN guideline options, they get two options to choose from. Both of those based off of utility. None of it’s based off of efficacy because no one’s tested in this late line study group before. Obviously, the most relevant data comes from the iNNOVATE study using rituximab monotherapy which we are using here again as one of the choices. Just to give you a sense in that iNNOVATE study, if you look at the major response rate rituximab monotherapy it was 22% with progression free survival of – median progression free survival around six months.

And so we think that again based off of our data that we stack up very nicely against that. The other arm will be – we’re finalizing that choice and I believe it will be a rituximab combination treatment where the expectation is it will perform very similar to the rituximab monotherapy.

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

Unidentified Analyst: Great, thanks. If you don’t mind, I have a one follow-up. For financial runway of cash to fourth quarter this year, does this include the work to complete IND filings for CLR 121225 and 125 [ph]? And what about the studies themselves and what the estimated cost of those Phase 1 studies? Thank you so much.

Jim Caruso: Sure. What – yes, go right ahead, Chad.

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

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

Unidentified Analyst: Great. Thank you so much.

Jim Caruso: Thank you.

Operator: Our next question comes from the line of Jonathan Aschoff from ROTH. Your line is open.

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

Jarrod Longcor: No, that is not correct, Jonathan. So they only get to choose one. There’s only two choices, right? One will be rituximab, one will be the other arm that we’re agreeing to with the FDA, we have to provide them with utilization data on our other choice. That’s what they want to see. How that breaks down…

Jonathan Aschoff: Sounds like what I said…

Jarrod Longcor: It’s – no, it’s not though. It’s not a 50/50, right? The physicians get to choose. It could be 90% rituximab monotherapy and 10% the other arm. We don’t know. We don’t have any control over that. So it’s 100% an investigator choice between two options.

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

Jim Caruso: Yes. We’re – obviously we’re very fortunate, right. We have a Phase 3 ready oncology asset in an area with high unmet medical need, with a substantial market both here and abroad, with the opportunity for orphan drug pricing and in a space with very, very limited treatment options. And likely one of the next one or two radiotherapeutics that would be approved in this space in an area that’s growing in a high degree of interest. So I mean, as you would expect there would be a lot of interest in an asset of that nature. I also believe, as I cited in my remarks that the clarity on the regulatory side has been very well received. And I believe those entities that are doing the asset also view this as very, very limited clinical risk.

And so you have a pretty much a clear pathway to approval with very low risk of not achieving the necessary results versus the comparator arms that Jarrod just cited earlier. So those deals could take on a number of different looks. I’ll have Jarrod talk to some, you know, broadly or in generally some of the types of deals that we would entertain.

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

Jim Caruso: And from a global licensing perspective, just for some clarity, Jonathan, from a global licensing perspective that would include a typical upfront payment, series of milestones and royalties back to our company. And then the entity that we assign those rights to would also be fully responsible for the economics associated with the – with the pivotal study and the responsibility for the execution of it. As Jarrod mentioned, based on our relationships that have been established and our experience in executing the Phase 2 and with those known contacts with those institutions and community based systems that will drive the majority of those both here and ex-U.S., that’ll be some additional value that we would bring to add [ph].

Additionally and importantly, all of the CMC related costs and manufacturing costs would also be responsibility of a third party. We would, obviously, because of our experience here and what we believe best-in-class radiotherapeutic manufacturing, we would be responsible for the manufacturing of the drug.

Jonathan Aschoff: Okay, thanks. Lastly, why pancreatic for 225? Is that based mostly on market need or was there some clearly differential preclinical efficacy signal?

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

Jim Caruso: One of the attractive natures of both of these Phase 1s is that, Jarrod will orchestrate this in such a way where we’ll receive dosimetry data on patients so we will very rapidly see the amount of drug that’s targeted to the tumor and also, within six, nine patients or so have a really good understanding of safety associated with this as well. So, it’s not a long pathway to evaluation. We believe both of these tumor types are – there’s clearly high unmet medical needs in very large markets and also high unmet medical need. And on the radiotherapeutic side of the equation, these solid tumor programs for these large bulky tumors are very rare. Based on the technology associated with delivery of these radioisotopes, and we believe, based on proof-of-concept with iopofosine and a significant amount of preclinical work, and obviously all the work we’ve done on the imaging and diagnostic side of the equation that our targeting platform is unique and will be able to deliver the isotope, regardless of the isotope, to the tumor high uptake as well as the associated safety that we observe with iopofosine.

Jonathan Aschoff: Thanks a lot. I’m glad you guys are having the inbound.

Jim Caruso: All right. Jonathan, thank you. We’ll see you next week at your conference. Thank you for the invitation.

Jonathan Aschoff: Got it. Bye.

Operator: [Operator Instructions] There are no further question at this time. Mr. Caruso, please go ahead.

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

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