Earnings call transcript: Cellectar Biosciences Q4 2024 sees restructuring amid losses

Cellectar Biosciences Inc. reported a net loss of $44.6 million, or $1.22 per share, for the fiscal year 2024. Despite the loss, the company has extended its cash runway to the fourth quarter of 2025, thanks to a significant cost-saving restructuring that reduced its workforce by 60%. The company’s stock price fell by 5.5% following the announcement, trading at $0.2992, as investors reacted to the financial results and strategic updates. According to InvestingPro data, the company’s overall financial health score stands at 1.47, indicating significant challenges ahead. The company’s market capitalization has contracted to just $13.88 million, reflecting investor concerns about its rapid cash burn rate.

Key Takeaways

• Cellectar reported a net loss of $44.6 million for 2024, with EPS at -$1.22.
• The company reduced its workforce by 60%, aiming for $7.5 million in annual savings.
• Cash and cash equivalents increased to $23.3 million as of December 31, 2024.
• Stock price dropped 5.5% following the earnings announcement.
• New Phase III study design for iapopacine agreed with the FDA.

Company Performance

Cellectar Biosciences has faced financial challenges, ending 2024 with a net loss of $44.6 million. This marks a challenging year for the company, which has been actively working on its portfolio of radiopharmaceuticals. The restructuring effort is a critical move to manage costs and extend the company’s financial runway into late 2025. Despite these hurdles, Cellectar is advancing its clinical programs, particularly in oncology, targeting areas with high unmet needs.

Financial Highlights

• Cash and cash equivalents: $23.3 million (up from $9.6 million in 2023)
• Research and Development expenses: $26.1 million (down from $27.3 million in 2023)
• Selling, General & Administrative expenses: $25.6 million (up from $11.7 million in 2023)
• Net loss: $44.6 million, or $1.22 per share

Outlook & Guidance

Cellectar is focusing on expanding its pipeline with a new Phase III study for iapopacine in Waldenstrom’s Macroglobulinemia, expected to enroll 100 patients per arm with a projected cost of $40-45 million. The company also plans to initiate Phase I studies for its pancreatic and breast cancer programs in the first half of 2025. Cellectar is exploring licensing opportunities for iapopacine to further support its financial and strategic goals.

Executive Commentary

CEO Jim Caruso expressed confidence in iapopacine’s potential, stating, "We remain confident in the potential value iapopacine will provide to patients suffering from this incurable disease." COO Jared Loncore highlighted the company’s unique technology, saying, "Our technology allows the optimization of both essential elements and has demonstrated in vivo the differential benefit between isotopes for specific tumor types."

Risks and Challenges

• Financial sustainability remains a concern, with significant net losses reported.
• The success of upcoming clinical trials is crucial for future growth.
• Regulatory hurdles may arise as the company seeks FDA approval for its treatments.
• Market competition in the radiopharmaceutical sector could impact Cellectar’s positioning.
• Potential delays in securing licensing or funding partnerships could affect operations.

Cellectar’s strategic focus on high unmet medical needs in oncology, coupled with its ongoing clinical advancements, positions it as a potential leader in the radiopharmaceutical market. However, the company must navigate financial constraints and regulatory challenges to achieve its long-term objectives. Analyst price targets range from $1 to $13, suggesting significant potential upside despite current challenges. For deeper insights into Cellectar’s valuation and prospects, including exclusive Fair Value calculations and comprehensive financial analysis, visit InvestingPro, where you’ll find detailed research reports covering over 1,400 US stocks.

Full transcript - Cellectar Biosciences Inc (CLRB) Q4 2024:

Conference Operator: you, gentlemen. Thank you for staying back 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 Ann Marie Fields, Managing Director at Precision HQ. Please go ahead.

Ann Marie Fields, Managing Director, Precision HQ: Thank you, operator. Good morning, and welcome to Selectar Biosciences’ fourth quarter and full year twenty twenty four financial results and business update conference call. Joining us today from Selectar are Jim Caruso, President and CEO, who will provide an overview of the company’s progress before turning the call over to Chad Colian, CFO, for a financial review of the quarter and the year. Following this, Jared Loncore, Chief Operating Officer, will give an update on the company’s progress and plans for its promising clinical development pipeline of radiopharmaceuticals. Selectar issued a press release earlier this morning detailing the contents of today’s call.

A copy can be found on the Investor page of Selectar’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, 03/13/2025. 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’ll begin the call with prepared remarks and then open the lines for your questions. I’ll now turn the call over to Jim Caruso.

Jim?

Jim Caruso, President and CEO, Selectar Biosciences: Thank you, Ann Marie. And thank you to all for joining us this morning as we share Selectar’s recent regulatory progress with iapopacine, our ongoing preparations to advance our alpha and o g 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. Twenty twenty four can be described as a bittersweet year for Selector, starting with the announcement of excellent clinical results from our CLOVER WAN study of iofolucine I-one hundred and thirty one for the treatment of relapsedrefractory Waldenstrom’s macroglobulinemia or W1. 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, iofofacin demonstrated an impressive ninety eight point two percent clinical benefit rate, eighty three point six percent overall response rate and a major response rate of fifty eight point two percent.

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 I am focusing 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 twenty twenty five, which adversely impacted our stock price toward the end of last year. As the clinical data demonstrates, I have focusing 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 iupofacin’s significant market potential in the relaxed refractory setting. This potential is driven by iupofacin’s novel mechanism of action, its distinctive product profile and size of the relapsed refractory market. In addition to clinical benefits and the product profile, other key attributes include a fixed dosing regimen, a unique 17 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 IaFocusing as a promising therapeutic candidate in this challenging market segment and Selector remains committed to bringing this 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 imopithecine and WM. I am pleased to share that we have achieved alignment on the design of a Phase three study required for market approval. Later in this call, Jared will discuss the study design, the cost efficiency and projected timelines to advance iofofacin toward commercialization. Given the strong enthusiasm surrounding iofofacin among patients, key opinion leaders in WN and the broader healthcare community, we are confident that the study will achieve rapid enrollment. This moped underscores the high level of interest in iofofacin 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 dilute upon

Chad Colian, CFO, Selectar Biosciences: the approach.

Jim Caruso, President and CEO, Selectar Biosciences: In addition to our late stage ioflucine program in WN, we remain bullish on our solid tumor focused radioisotope programs, which include our alpha emitter for pancreatic cancer and the OG emitter for evaluation in triple negative breast cancer, both of which highlight the novel utility of our delivery platform. As mentioned earlier, the delay in our NDA submission for iapofacine 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 iofocipine and WM, acquisition of non dilutive funding, technology validation through third party collaborations and progress with our Phase one 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 Colian, CFO, Selectar Biosciences: Thank you, Jim. In 2024, we executed multiple financial transactions that strengthened Selector’s balance sheet, including investors exercise of warrants in January, generating $44,100,000 and an inducement financing in July, which included the exercise of existing warrants and the purchase of new warrants for $19,400,000 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 reevaluation of the accounting for warrants issued prior to 2023. As a reminder, at the time of issuance, the warrants were classified as equity based

Jim Caruso, President and CEO, Selectar Biosciences: upon

Chad Colian, CFO, Selectar Biosciences: internal and external assessment. As supported by our existing accounting firm at that time and a global professional services firm, which provided an expert third party evaluation. A subsequent internal review determined that these warrants should have been classified as liabilities, which necessitated the revision to our historical reporting. Importantly, the restatement had no impact on historical cash or cash burns 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 12/31/2024, we ended the year with cash and cash equivalents of $23,300,000 as compared to $9,600,000 as of 12/31/2023.

Based upon the delay in Iapocea’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 $7,500,000 annually and to extend our cash runway into the fourth quarter of twenty twenty five. Moving to the operating results. Research and development expenses for the full year 2024 were approximately $26,100,000 compared with $27,300,000 in

Jared Loncore, Chief Operating Officer, Selectar Biosciences: the prior

Chad Colian, CFO, Selectar Biosciences: year. The decrease was largely driven by the timing of expenditures for our WM Phase two study to support patient enrollment and follow-up visits and was partially offset by the extensive analytic work necessary to prepare for a planned NDA submission, product sourcing and expansion of manufacturing and logistics infrastructure costs to support multi sourcing each aspect of IO focusing on production. Selling, general and administrative expenses for the full year 2024 were $25,600,000 compared to $11,700,000 in the prior year. These incremental investments were largely due to pre commercialization initiatives such as product related to 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 ipofacine, enhancing the value of and supporting our funding efforts and potential collaborations with prospective partners.

Other income and expense net was approximately $7,400,000 of income in 2024 as compared to approximately $3,900,000 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 $1,200,000 from $400,000 in 2023. Net loss for the full year ended 12/31/2024 was $44,600,000 or $1.22 per basic share and $1.4 per fully diluted share compared to $42,800,000 or $3.5 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 additional one hundred and eighty day remediation period to refresh the $1 bid price for the stock. NASDAQ also maintains the right to grant an additional one hundred and eighty day remediation period upon request, provided the company meets all other listed criteria. If necessary, we will request an additional one hundred and eighty 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 this call over to Jared for an operational update, including plans for our promising pipeline of radiopharmaceuticals.

Jared Loncore, Chief Operating Officer, Selectar Biosciences: Thank you, Chad, and good morning, everyone. I will begin by providing a regulatory update on iapopacine 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 II 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 iapopecine I-one hundred and thirty one, 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 iapopecine in WM patients. The path requires the completion of a confirmatory randomized controlled study, iapopcine I-one hundred and thirty one 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 Selector have agreed upon the major protocol elements and the requirements for accelerated and full approval. The approval process is anticipated to proceed in two stages.

The conditional accelerated approval is based upon major response 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 twenty four months of the first patient treatment. The total cost is between $40,000,000 and $45,000,000 We estimate that approximately $30,000,000 will be required to achieve full enrollment, which facilitates the NDA submission for conditional approval. The approximately $15,000,000 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 IAPOCI and I-one 31 to market for the treatment of relapsedrefractory 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, Selector 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. Ibuprofen 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 accomplished 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 the differential benefit between isotopes for specific tumor types. I will now review two of our exciting early stage radio conjugates. The first is our alpha emitting actinium based compound CLR12125 and the second is CLR112125, our lead Auger emitter. CLR12125 is our lead alpha and conjugate product candidate that has shown excellent cloud distribution and uptake into 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-one hundred and twenty one thousand two hundred and twenty five has been shown to be safe and well tolerated.

Like iapopacine, 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 CLR11225. We continue to evaluate additional CDMOs to ensure capacity for indication expansion and long term risk mitigation. The Phase one trial for CLR-one hundred and twenty one thousand two hundred and twenty five 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-one hundred and twenty one thousand two hundred and twenty five 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 Selecta, 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 twenty twenty five. OJ 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-one 20 one-one 25 apart in the landscape of radiopharmaceuticals and potentially offering a new paradigm in targeted cancer therapy. We are strategically positioned to advance CLR-one 20 one-one 25, our lead OJE emitter using Iodine-one 25 as radio conjugate product into the next stage of development.

The activity of CLR-one 20 one-one 20 five’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-one hundred and twenty one thousand two hundred and twenty five, we are preparing CLR-one hundred and twenty one-one 25 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 two dose. The study will include an imaging component to further elucidate the biodistribution of CLR-one hundred and twenty one-one hundred and twenty five providing crucial insights into its targeting and potential efficacy.

By focusing on triple negative breast cancer, we are targeting an aggressive and difficult to treat subtype of breast cancer, underscoring our commitment to addressing high unmet medical needs. The strategic decision to pursue this indication aligns with our broader mission to develop innovative therapies for challenging malignancies. Success in this area could be particularly impactful given the limited treatment options currently available for triple negative breast cancer patients. We anticipate the positive data from this study could significantly enhance the value proposition of CLR-one hundred and twenty one-one 25 and by extension our entire radiopharmaceutical platform. These trials represent a critical step in our pipeline development, potentially positioning both CLR-one hundred and twenty one-two 25 and CLR-one 20 one-one hundred and 20 five 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 about 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, President and CEO, Selectar Biosciences: Thank you, Jerry. As you can see, we are off to a very good start in 2025 by rapidly securing clarity on the FDA’s requirements for a conditional approval under the accelerated approval pathway. To state the obvious, this is a significant achievement and asset value enhancement. As I previously reported, we are in advanced discussions with multiple companies regarding the licensing rights for IFOQ. The regulatory strategy established with the FDA provides a clear and cost efficient regulatory pathway forward for IFOPOCIEN with what we believe to be limited clinical and execution risk.

In essence, the regulatory clarity has significantly enhanced the value of IFOPOCIEN. Non dilutive cash associated with these potential deals would be highly beneficial for the company. In addition, we will be prepared to initiate Phase one studies for both the alpha actinium based radial conjugate in pancreatic cancer and the OG emitter for triple negative breast cancer in the first half of twenty twenty five. The initiation of these respective studies are to be determined. Our current cash position extends into the fourth quarter of twenty twenty five, which we believe provides ample time to evaluate and advance non dilutive licensing deals and potential funding vehicles and in parallel assess timing for the initiation

Jared Loncore, Chief Operating Officer, Selectar Biosciences: of our Phase one assets.

Jim Caruso, President and CEO, Selectar Biosciences: Before opening the call to your questions, I would like to thank our dedicated and talented Select Art 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 iapofacin 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 goals. Operator, we are ready to open the call to questions.

Conference Operator: Thank you. Our first question comes from the line of Jeff Jones from Oppenheimer. Your line is open.

Fani, Analyst, Oppenheimer: Thanks for the update. This is Fani on for Jeff.

Conference Operator: A clarity question for NDA

Fani, Analyst, Oppenheimer: for IL-one hundred and thirty one. Does the NDA on such record MR data from the complementary study or just the COVID-nineteen WN? And I have follow-up. Thanks.

Jared Loncore, Chief Operating Officer, Selectar Biosciences: Sorry. Let me you were breaking up there pretty bad, so I’m not 100% sure I captured everything that you were trying to question. Was the question for the NDA submission, does it require data from a new study or is it just from the CLOVER WAM study?

Fani, Analyst, Oppenheimer: Yes. I mean, the NDA acceptance require the MRR data from the complementary study or just the CLOVER study?

Jared Loncore, Chief Operating Officer, Selectar Biosciences: Yes. The accelerated approval will require data from the additional study as well.

Fani, Analyst, Oppenheimer: Got you. Thanks. So can you share the timeline for patients to achieve and be validated for MRR response under the anticipated study design?

Jim Caruso, President and CEO, Selectar Biosciences: Certainly. Hi, this is Jim. Before I turn that question over to Jared, we do anticipate rapid enrollment in this study based on our obviously the drug’s performance in the Phase II, where we achieved outstanding clinical results and quite frankly a very impressive adverse event profile as well. The WM community was very disappointed that there would be a delay to market for ihopalazine. 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 Jared to provide some detail around this.

Jared Loncore, Chief Operating Officer, Selectar Biosciences: 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 twenty four months to full enrollment. And then with the change to major response rate being approximately thirty days, that it would basically be one more month to achieve the necessary outcomes for major response rate.

Fani, Analyst, Oppenheimer: Great. Very helpful. Thank you. And what would be the comparator be or any color on the comparator? Thanks.

Jim Caruso, President and CEO, Selectar Biosciences: 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

Jared Loncore, Chief Operating Officer, Selectar Biosciences: of the reasons why we believe we have and our thought leaders and advisory council believe we have very limited clinical risk here. Jared? 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 is based off of efficacy because no one has 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 of rituximab monotherapy, it was twenty two percent 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. And for clarity,

Jim Caruso, President and CEO, Selectar Biosciences: both treatments will sum to 100 patients.

Fani, Analyst, Oppenheimer: Great. Thanks. If you don’t mind, I have a one follow-up. For financial runway of cash to fourth quarter this year, this include the work to complete IND filing for CLR 01/5125. And what about the studies themselves and what the estimated cost of those Phase one studies?

Thank you so much.

Jim Caruso, President and CEO, Selectar Biosciences: Sure. Go right ahead, Charles.

Chad Colian, CFO, Selectar Biosciences: 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 one trials running and that is also encompassed in the cash runway that we presented earlier.

Jared Loncore, Chief Operating Officer, Selectar Biosciences: And the cost associated with each of those studies is in the ballpark of about $4,500,000

Conference Operator: Great. Thank you so much.

Jim Caruso, President and CEO, Selectar Biosciences: Thank you.

Conference Operator: Our next question comes from the line of Jonathan Askov from Roth. Your line is open.

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

Jared Loncore, Chief Operating Officer, Selectar Biosciences: No, that is not correct, Jonathan. So they only get to choose 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 Askov, Analyst, Roth: Sounds like what I said.

Jared Loncore, Chief Operating Officer, Selectar Biosciences: No, it’s not though. It’s not a fiftyfifty, 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 Askov, Analyst, Roth: 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, President and CEO, Selectar Biosciences: Yes. Obviously, we’re very fortunate, right? We have a Phase III 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 renewing 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 Jared just cited earlier. So those deals could take on a number of different looks. I’ll have Jared talk to some broadly or generally some of the types of deals that we would enter.

Jared Loncore, Chief Operating Officer, Selectar Biosciences: Yes. So to your point, Jonathan, 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. And from

Jim Caruso, President and CEO, Selectar Biosciences: 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 would assign those rights to would also be fully responsible for the economics associated with the pivotal study and the responsibility for the execution of it. As Jared mentioned, based on our relationships that have been established and our experience in executing the Phase II and with those known contacts with those institutions and community based systems that will drive the majority of those patients, both here and ex U. S, that’ll be some additional value that we would bring to add. Additionally, and importantly, all of the CMC related costs, 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 Askov, Analyst, Roth: Okay. Thanks. Lastly, why pancreatic for 02/25? Is that based mostly on market need or was there some clearly differential preclinical efficacy signal?

Jared Loncore, Chief Operating Officer, Selectar Biosciences: 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 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, President and CEO, Selectar Biosciences: One of the attractive natures of both of these Phase 1s is that JARED 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 to valuation. We believe both of these tumor types are there’s clearly high unmet medical need in very large markets and also high unmet medical need.

And on the radiotherapeutic side of the equation, these solid tumor programs for these large bulky tumors are very rare based on the technology associated with delivery of these radioisotopes. And we believe based on proof of concept with iapofacin and a significant amount of preclinical work and obviously all the work we’ve done on the imaging and diagnostic side of the equation that our targeting platform is unique and we’ll be able to deliver the isotope regardless of the isotope to the tumor, high uptake as well as the associated safety that we observe with iOpofacin.

Jonathan Askov, Analyst, Roth: Thanks a lot. And I’m glad you guys are having the inbounds.

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

Jonathan Askov, Analyst, Roth: Got it.

Conference Operator: There are no further questions at this time. Mr. Caruso, please go ahead.

Jim Caruso, President and CEO, Selectar Biosciences: 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.

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

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