3/13/2025

speaker
Conference Call Operator
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 PrecisionAQ. Please go ahead.

speaker
Selectar Bioscience Conference Call Moderator
Moderator

Thank you, Operator. Good morning and welcome to Selectar Bioscience's fourth quarter and full year 2024 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 Coley, 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 filing. 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'll 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?

speaker
Jim Caruso
President and CEO, Selectar Bioscience

Thank you, Anne-Marie, and thank you to all for joining us this morning as we share Selectar's recent regulatory progress with iFocusing, our ongoing preparations to advance our alpha and OG radioisotope solid tumor programs, and forward-looking plans to address the company's NASDAQ status and future funding, including evaluation of non-available funding opportunities. 2024 can be described as a bittersweet year for SelectR, starting with the announcement of excellent clinical results from our Clover-WAM study of Iopococine I131 for the treatment of relapsed refractory Waldenstrom's macroglobulinemia, or WM, 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, iaprofising 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 pre-survival and time to next treatment. We remain confident in the potential value I am focusing will provide 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 toward the end of last year. As the clinical data demonstrates, hypophysine offers potential to be a meaningful treatment for all relapsed refractory WM patients. As such, and aligned it 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 iapofasin's significant market potential in the relaxed refractory setting. This potential is driven by iapofasin's novel mechanism of action, its distinctive product profile, and size of the relaxed refractory market. 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 Iapocasin as a promising therapeutic candidate in this challenging market segment and SelectR 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 ibuprofen and WM. I am pleased to share that we have achieved alignment of 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 iapofasine toward commercialization. Given the strong enthusiasm surrounding iapofasine among patients, key opinion leaders in WM, and the broader healthcare community, we are confident that the study will achieve rapid enrollment. This moment underscores the high level of interest in iapofasine 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 WAMP 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-by-Luda funding approach. In addition to our late-stage iopopacin 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 MDA submission for iopopacin 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 IFO proceeding WM, acquisition of non-dilutive funding, technology validation through third-party collaborations, and progress with our Phase I-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?

speaker
Chad Coley
Chief Financial Officer, Selectar Bioscience

Thank you, Jim. In 2024, we executed multiple financial transactions that strengthened SelectR's balance sheet, including investors' exercise of Lawrence 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 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. 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 IFOC and NDA submission and lack of regulatory clarity, We implemented a cost-saving strategic restructuring, which reduced headcount by approximately 6%. 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 WMH2 study to support patient enrollment and follow-up visits, and was partially offset by the extensive analytical work necessary to prepare for a planned NDA submission, product sourcing, and expansion of manufacturing and logistics infrastructure costs to support multi-sourcing for each aspect of high-opacity Iowa 31 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 Iapofasine, enhancing the value of Iapofasine 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 of 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. 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 108-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.

speaker
Jared Loncore
Chief Operating Officer, Selectar Bioscience

Thank you, Chad, and good morning, everyone. I will begin by providing a regulatory update on hypoxine 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 6th, and I am pleased to report that we successfully achieved a crucial milestone for the future development of apophysin 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 Iopopcine in WM patients. The path requires the completion of a confirmatory randomized controlled study of Iopopcine I131 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 Selectar 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 and We anticipate that the study will enroll rapidly and to achieve full enrollment within approximately 24 months of the first patient treatment. The total cost is between $40 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 remaining will be required for the determination of PFS and long-term follow-up, and study closure. This approach aligns with FDA guidance and provides a well-defined path to potentially bring ayoprofen and I-131 to market for the treatment of relapse 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 design 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, Selectar 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. Iopovacine 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, CLR121225. And the second is CLR121125, our lead OJ emitter. CLR121225 is our lead alpha emitter conjugate product candidate that has shown excellent biodistribution 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, CLR121225 has been shown to be safe and well-tolerated. Like iapovacine, we have established a network of isotope and finished product CDMOs to guarantee sufficient supply in the near and long term for the full development of CLR121225. We continue to evaluate additional CDMOs to ensure capacity for indication expansion and long-term risk mitigation. The Phase I trial for CLR121-225 is designed to comprehensively evaluate the compounds of 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 distribution 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 CLR121-225 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 radioconjugate'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 Selector, 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. OG 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 CLR121-125 apart in the landscape of radiopharmaceuticals and potentially offering a new paradigm in targeted cancer therapy. We are strategically positioned to advance CLR121-125, our lead OJ emitter, using iodine-125 as radioconjugate product, into the next stage of development. The activity of CLR121-125'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 CLR121-225, we are preparing CLR121-125 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 CLR121125, 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 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 CLR121-125, and by extension, our entire radiopharmaceutical platform. These trials represent a critical step in our pipeline development, potentially positioning both CLR121-225 and CLR121-125 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?

speaker
Jim Caruso
President and CEO, Selectar Bioscience

Thank you, Jared. As you can see, We are off to a very good start in 2025 by rapidly securing clarity on the FDA's requirements for conditional approval under the Accelerated Approval Pathway. To state the obvious, this is a significant achievement, an asset value enhancer. As I previously reported, we are in advanced discussions with multiple companies regarding the licensing rights for Iofocusin. regulatory strategy established the FDA provides a clear and cost-efficient regulatory pathway forward for our focusing with what we believe to be limited clinical and execution risk in essence the regulatory clarity has significantly enhanced the value of our focusing non-vendor of cash associated with these potential deals would be highly beneficial for the company In addition, we will be prepared to initiate Phase I 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 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 timing for the initiation of our phase one assets. Before opening the call to your questions, I would like to thank our dedicated and talented SelectArt 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 ibuprofen 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.

speaker
Conference Call Operator
Operator

Thank you. Ladies and gentlemen, we will now conduct the question and answer session. If you have a question, please press the star key followed by one on your touchtone phone. You will hear a one tone prompt acknowledging your request. Your questions will be pulled in order when they are received. If you would like to decline from the polling process, please press the pound key. One moment for your questions, please. Our first question comes from the line of Jeff Jones from Oppenheimer. Your line is open.

speaker
Jeff Jones
Analyst, Oppenheimer

Thanks for the update. This is for Jeff. A clarity question for NDIS acceptance for IL-POF and IL-131. Does the NDIS acceptance require NR data from the complementary study or just the CLBR WM? And I have follow-up. Thanks.

speaker
Jared Loncore
Chief Operating Officer, Selectar Bioscience

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 Wham study?

speaker
Jeff Jones
Analyst, Oppenheimer

Yeah, I mean, the NDA acceptance requires the MRR data from the complementary study, or just the

speaker
Jared Loncore
Chief Operating Officer, Selectar Bioscience

Yes, the accelerated approval will require data from the additional study as well.

speaker
Jeff Jones
Analyst, Oppenheimer

Got you. Thanks. So, can you share the timeline for a patient to achieve and be evaluated for an MRR response under the administrative study design?

speaker
Jim Caruso
President and CEO, Selectar Bioscience

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, you know, the phase two where we achieved outstanding clinical results and, quite frankly, a very impressive adverse event profile as well. You know, the WM community was very disappointed that there would be a delay to market for iopopacin. You know, 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, you know, 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.

speaker
Jared Loncore
Chief Operating Officer, Selectar Bioscience

Yeah. As Jim said, you know, 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, you know, with the change to major response rate being approximately 30 days, that it would basically be one more month to achieve the necessary outcomes for major response rate.

speaker
Jeff Jones
Analyst, Oppenheimer

Great. Very helpful. Thank you. And what would be the comparatively or any color on the comparator.

speaker
Jim Caruso
President and CEO, Selectar Bioscience

Thanks. 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. Jared?

speaker
Jared Loncore
Chief Operating Officer, Selectar Bioscience

Yeah, 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 an 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 INOVATE study using rituximab monotherapy, which we are using here, again, as one of the choices. Just to give you a sense, in that INOVATE study, if you look at the major response rate of 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.

speaker
Jim Caruso
President and CEO, Selectar Bioscience

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

speaker
Jeff Jones
Analyst, Oppenheimer

Yep. Great. Thanks. If you don't mind, I have a little follow-up there. For financial runway of cash to fourth quarter this year, does this include the work to complete IMD filing for CLR 121, 225, and 125? And what about the studies themselves and what the estimated cost of those phase one studies? Thank you so much.

speaker
Jim Caruso
President and CEO, Selectar Bioscience

Sure. Go right ahead, Charlie.

speaker
Chad Coley
Chief Financial Officer, Selectar Bioscience

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.

speaker
Jared Loncore
Chief Operating Officer, Selectar Bioscience

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

speaker
Jeff Jones
Analyst, Oppenheimer

Great. Thank you so much.

speaker
Jim Caruso
President and CEO, Selectar Bioscience

Thank you.

speaker
Conference Call Operator
Operator

Our next question comes from the line of Jonathan Ascoff from Roth. Your line is open.

speaker
Jonathan Ascoff
Analyst, Roth

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

speaker
Jared Loncore
Chief Operating Officer, Selectar Bioscience

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 is 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.

speaker
Jonathan Ascoff
Analyst, Roth

That's helpful. Do you wish to allow us to understand that all the range of deal types you're entertaining for 131?

speaker
Jim Caruso
President and CEO, Selectar Bioscience

get that trial started yeah we're obviously we're very fortunate right we have a phase three ready oncology asset I'm in an area with high medical need with a substantial market both here and abroad with the opportunity for orphan drug pricing and 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 earlier, that the clarity on the regulatory side has been very well received. And I believe those entities that are reviewing 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 you know, the necessary results versus, you know, 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, you know, broadly or generally, you know, some of the types of deals that we would entertain.

speaker
Jared Loncore
Chief Operating Officer, Selectar Bioscience

Yeah, so to your point, Jonathan, and I think we've talked about this in the past, you know, 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 Asian 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 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.

speaker
Jim Caruso
President and CEO, Selectar Bioscience

And from a global licensing perspective, just for some clarity, Jonathan, from a global licensing perspective, You know 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 with the pivotal study and the responsibility for the execution of it as Jared mentioned and you know, based on our relationships that have been established in our experience in executing the phase two and with those known contacts with those institutions and community-based systems that will drive the majority of those patients both here and XUS, you know, that'll be some additional value that we would bring to add. 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.

speaker
Jonathan Ascoff
Analyst, Roth

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

speaker
Jared Loncore
Chief Operating Officer, Selectar Bioscience

Yeah, 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 falco adenocarcinoma. You know, 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.

speaker
Jim Caruso
President and CEO, Selectar Bioscience

One of the attractive natures of both of these phase ones is that, you know, 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, you know, 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 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 iapophysine 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 iapophysine.

speaker
Jonathan Ascoff
Analyst, Roth

Thanks a lot, and I'm glad you guys are having the inbounds.

speaker
Jim Caruso
President and CEO, Selectar Bioscience

All right. Jonathan, thank you. We'll see you next week at your conference. Thank you for the invitation. You got it. Bye.

speaker
Conference Call Operator
Operator

Again, if you would like to ask the question, please press start and the number one on your telephone keypad. There are no further questions at this time. Mr. Caruso, please go ahead.

speaker
Jim Caruso
President and CEO, Selectar Bioscience

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.

speaker
Conference Call Operator
Operator

Ladies and gentlemen, this concludes the conference call for today. Thank you for participating.

Disclaimer

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