Full Year 2024 Cellectar Biosciences Inc Earnings Call
Ladies and gentlemen, thank you.
Right.
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 maybe recorded.
Speaker Change: I would now like to hand, the conference call over to Anne Marie fields, Managing director position. Thank you. Please go ahead.
Okay.
Speaker Change: Thank you operator.
Speaker Change: Morning, and welcome to the Selecta Biosciences fourth quarter and full year 'twenty 'twenty four financial results and business update conference call joining us today from select Saar are Jim Caruso, President and CEO, who will provide an overview of the company's progress before turning the call over to Chad colleague and CFO for a financial review of the quarter and the year.
Speaker Change: Following this Jared Law Court Chief operating officer will give an update on the company's progress and plans for its promising clinical development pipeline of Radiopharmaceuticals.
Speaker Change: So let's start issued a press release earlier this morning detailing the contents of today's call a copy can be found on the investor page at select corporate web site.
Speaker Change: I wanted 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.
Speaker Change: Contents of this conference call contains time sensitive information that's accurate only as of the date of this live broadcast March.
Speaker Change: 13th 2025, and 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.
Speaker Change: 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.
Jim Caruso: Thank you Anne Marie.
Jim Caruso: That you all for joining us this morning, as we share select doors recent regulatory progress with higher pulp machine.
Jim Caruso: Our ongoing preparations to advance our alpha and Oh, Gee radioisotopes solid tumor program.
Jim Caruso: Forward looking plans to address the competition aspect status and future funding, including the valuation.
Jim Caruso: Quite the opposite.
Jim Caruso: 'twenty three 'twenty four can be described as a bittersweet year for select dark starting with the announcement of excellent clinical results from our Clover Wans study of Io pulp machine I want three one for the treatment of relapsed refractory factory Walton strong macroglossia or ductless and.
In concluding.
Jim Caruso: Disappointing regulatory news, which still is the submission of the new drug application or NDA for conditional approval under the accelerated approval process and the Clover Wham study I am focusing demonstrated an impressive 88, 2% clinical benefit rate 83.
Jim Caruso: 6% overall response rate and a major response rate of 58.2%. These.
Jim Caruso: These clinical outcomes are particularly meaningful for this challenging to treat relapsed refractory elderly patient population for.
Jim Caruso: Are these patients limited reduction in tumor burden or shipment of disease stability.
Jim Caruso: 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 regulatory shut back 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.
Jim Caruso: As the clinical data demonstrates focusing offers potential to be a meaningful treatment for all relapsed refractory <unk> patients as such a lot of it with the FDA, we re crafted the paths to market through the accelerated approval process.
Jim Caruso: Our comprehensive product market research market sizing and commercial analysis underscores our polka seen significant market potential in the relapsed refractory setting.
Jim Caruso: Potential is driven by I appreciate its novel mechanism of action its distinctive product profile and size of the relapsed refractory Mark.
Jim Caruso: In addition to clinical benefits and the product profile. Other key attributes include a fixed dosing regimen of unique 17th day shelf life orphan drug pricing and its ability to address a high unmet clinical need and the landscape with limited approved treatment.
Jim Caruso: These factors collectively position focusing.
Jim Caruso: Pharmacy and therapeutic candidate in this challenging market segment, and select remains committed to bringing potentially life saving drug to patients.
Jim Caruso: To benefit from the Street.
To this end, we recently held a very productive meeting with the FDA to finalize the regulatory pathway for I hope the same thing Wm.
Jim Caruso: Pleased to share that we have achieved one of the design of the phase III studies required for market approval later in this call January let's discuss the study design the cost efficiency and projected timelines to advance <unk> towards commercialization.
Jim Caruso: Given the strong enthusiasm surrounding I am focusing among patients can your opinion leaders in Wm and the broader health care community.
Jim Caruso: The study will achieve rapid enrollment.
Jim Caruso: Underscores the high level of interest and our focus as a potential therapy for this challenging disease and reflects significant promise addressing unmet clinical needs.
Jim Caruso: Based upon the quality of the Clover Wham data limited perceived clinical risk to approval and a robust global market opportunity. We continue to evaluate inbound inquiries regarding a range collaboration and licensing deals which is our preferred non pet food upon me.
Jim Caruso: <unk>.
Jim Caruso: In addition to what the bid stage <unk> program in February we remain bullish on our solid tumor focused radioisotope programs, which include our alpha emitters for pancreatic cancer and the oshie emitter for valuation in triple negative breast cancer.
Jim Caruso: Of which highlight the novel utility of our delivery platform.
Jim Caruso: As mentioned earlier the delay in our NDA submission for IV <unk> adversely impacted the company 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 IR purposes.
W. At acquisition of non dilutive funding technology validation as to a third party collaborations and progress with our phase one ready radioisotope assets, along with the removal of any perceived financial overview.
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 Colleague: Thank you Jim.
Chad Colleague: In 2024, we executed multiple financial transactions that strengthened select our balance sheet, including investors exercise of warrants in January generating $44 1 million.
Chad Colleague: And an inducement financing in July which included the exercise of existing warrants and the purchase of <unk>.
Chad Colleague: New awards were $19 4 billion in protein.
Chad Colleague: Okay.
Chad Colleague: As we communicated last October we refiled, our historical financial statements for fiscal years 2023 and 2022.
Chad Colleague: And action that was precipitated by a reevaluation of the accounting.
Chad Colleague: Issued prior to 2023.
As a reminder, at the time of issuance the worse were classified as equity based upon internal and external assessments.
Chad Colleague: Supported by our existing accounting firm at that time.
Chad Colleague: And a global professional services firm, which provided an expert third party evaluation.
Chad Colleague: A subsequent internal review, we 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 imported.
Chad Colleague: And the changes to earnings were all nonoperating and noncash.
Chad Colleague: Now turning to our financial results for 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.
Chad Colleague: Based upon the delay in <unk>.
Chad Colleague: NDA submission and lack of regulatory clarity, we implemented a cost savings strategic restructuring, which reduced head count by approximately six seven.
Chad Colleague: We expect restructuring to drive savings of approximately $7 million annually and to extend our cash runway into the fourth quarter of 2020.
Chad Colleague: Moving to the operating results.
Chad Colleague: Research and development expenses for the full year 2024 were approximately $26 1 million compared with $27 3 million in the prior year.
Chad Colleague: The decrease was largely driven by the timing of expenditures for our Wm case to study to support patient enrollment and follow up visits and was partially offset by the extensive analytical work necessary to prepare for our planned NDA submission product sourcing expansion in manufacturing and logistics infrastructure.
Chad Colleague: <unk> costs to support multi sourcing each aspect of Io, focusing and I hope everyone production.
Chad Colleague: Selling general and administrative expenses for the full year 'twenty.
Chad Colleague: $25 6 million compared to $11 7 million in the prior year.
Chad Colleague: 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.
Chad Colleague: Sale of our distribution and channel development.
Chad Colleague: This research and analytical work product further validated the substantial wm market opportunity for <unk>.
Chad Colleague: Enhancing the value of our hypotheses and supporting our funding efforts.
Speaker Change: Tangela collaborations with respective partners.
Speaker Change: Other income and expense net.
Speaker Change: It was approximately $7 4 million of income in 2024 as compared to approximately $3 9 million of expense in the prior years.
Speaker Change: These amounts are almost exclusively noncash and are driven by the issuance and valuation of equity securities in conjunction with our financing activities.
Speaker Change: The only component of this category of pit cash is interest income, which for the year. Just ended improved to approximately $1 2 million from 4 billion in 2023.
Speaker Change: Net loss for the full year ended December 31, 2024 was $44 6 million or $1 22 per basic share and $1 44.
Our fully diluted share.
Speaker Change: Compared to $42 8 million or $3.50 per basic and fully diluted share during 2023.
Speaker Change: Addressing our compliance with the continued listing requirements for Nasdaq.
Speaker Change: As Jim noted in his opening remarks, we are engaged in a broad variety of fronts to further strengthen the balance sheet and enhance the valuation of the company.
Speaker Change: NASDAQ provides an additional 100, an initial 180 day remediation period.
Speaker Change: Okay price of the stock.
Speaker Change: Yes, Zach also maintains the right to grant an additional 180 day remediation period upon request.
Speaker Change: <unk> the company meets all other listing criteria.
Speaker Change: If necessary, we will request an additional 180 remediation period.
Speaker Change: In addition to create corporate Optionality.
Speaker Change: I'll ask our stockholders to approve a possible reverse stock split.
Speaker Change: Part of our June 2025 annual meeting.
Speaker Change: Of course, a reverse split would only be implemented if all other initiatives have been exhausted.
Speaker Change: And it is deemed absolutely necessary to do so.
Speaker Change: We believe this multifaceted approach enables the company's ability to maintain optionality and deliver the best available outcome for all constituencies.
Speaker Change: I will now turn this call over to Jared for an operational update including plans for a promising pipeline of Radiopharmaceuticals.
Jared Law: Thank you Chad and good morning, everyone.
Speaker Change: I will begin by providing a regulatory update on <unk> for the treatment of <unk>.
Following our.
Speaker Change: Our November 2024, FDA meeting, we sought to obtain additional clarity on the agencies preferred study designed 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.
Speaker Change: The formal meeting was held on March six and I am pleased to report that we successfully achieved a crucial milestone for the future development of <unk> 131, establishing a clear regulatory pathway for a promising drug.
Speaker Change: We view the outcome is a significant win and believe it sets a clear path to the NDA submission and market approval for <unk> in Wm patients.
Speaker Change: The past requires the completion of a confirmatory randomized controlled study by focusing I 131 versus the comparator arm, which will provide the study investigators a choice between one up to N. CCN approved treatment options. This trial is expected to enroll approximately 100 patients per arm.
Speaker Change: With the FDA and select sorry have agreed upon the major protocol elements and the requirements for accelerated and full approval.
Speaker Change: The approval process is anticipated to proceed in two stages additional accelerated approval is based upon major response rates subsequently.
Speaker Change: Full approval is contingent upon achieving progression free survival.
We anticipate that the study to enroll Wilson will rapidly and to achieve full enrollment within approximately 24 months of the first patient treated.
Speaker Change: 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 for meeting would be required for the determination of PFS long term follow up.
And study closure.
Speaker Change: This approach aligns with FDA guidance and provides a well defined path to potentially bring <unk> 31 to market for the treatment of relapsed refractory <unk> 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.
Speaker Change: In addition to these activities Celexa is employing our proprietary phospholipid drug conjugate or PDC tumor targeting delivery platform to develop unique potentially game changing cancer treatments are pdc's possess the potential to deliver improved efficacy and better safety, resulting from improved targeting of various oncology payloads.
Speaker Change: Due to the tumor.
I, probably seen clearly provides clinical proof of concept for the platform what the targeted delivery of a radioisotope.
Based upon this validation we have developed a broad proprietary pipeline that includes other targeted radio isotopes small molecules peptides and oligonucleotides each of which has been validated in vitro and in vivo.
Speaker Change: 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.
Speaker Change: This provides the unique ability to more effectively selective 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 <unk>.
Speaker Change: Our ability and activity of each isotopes in each type of cancer.
Speaker Change: 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 the differential benefit between isotopes for specific tumor types.
Speaker Change: I will now review two of our exciting early stage radio conjugate. The first is our alpha actinium based compound CLR 121225, and the second is CLR 121125, I'll lead OJ and better.
Speaker Change: CLR 121225, as our lead Alpha emitting radio conjugate product candidate that has shown excellent bio distribution and uptake into tumors exhibiting activity across multiple solid tumor animal models, including challenging to treat pancreatic ductal adenocarcinoma and colorectal cancers.
Speaker Change: Importantly in all tumor types tested CLR 121225 has been shown to be safe and well tolerated.
Speaker Change: Like I have probably seen we have established a network of isotope and finished product CDM owes to guarantee sufficient supply in the near and long term for the full development of CLR 121225, we continue to evaluate additional CDM owes to ensure capacity for indication expansion and long term risk mitigation.
Speaker Change: The phase one trial for CLR 121225 is designed to be comprehensively evaluate the compounded bio distribution.
Speaker Change: <unk> and Tolerability in patients with pancreatic adenocarcinoma.
Speaker Change: The study will commence with the dosimetry phase aimed at determining the absorbed dose in both normal and turmoil in tumor tissue.
This initial assessment will provide valuable insights into the compounds are distribution and potential therapeutic window laying the foundation for subsequent phases of the trial and future development.
Speaker Change: Only 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 plc technology with Alpha emitters.
Speaker Change: <unk> potentially showcasing this radio conjugates unique ability to safely treat large bulky solid tumors. The significance of this trial extends beyond its immediate objective.
Speaker Change: Positive outcomes and 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 selected potentially opening new avenues for targeted radio therapeutics and rapidly advancing our position at the forefront of cancer treatment innovation, we will be prepared to initiate.
Speaker Change: This study in the first half of 2025.
Osha emitting isotopes represents the pinnacle of precision and targeted radiotherapy with admissions traveling only a few nanometers. This ultra short range necessitates delivery of the isotopes in close proximity to the cellular DNA to achieve therapeutic activity.
Speaker Change: Our proprietary PDC platform uniquely enables intracellular delivery and facilitates the necessary targeted delivery at the sub cellular level setting CLR 121125, apart in the landscape of Radiopharmaceuticals and potentially offering a new paradigm in targeted cancer therapy, we are strategically positioned to.
Speaker Change: Advanced CLR, one to one five our lead <unk> using <unk> 125 as radio conjugate product.
Speaker Change: Into the next stage of development.
Speaker Change: The activity of CLR, one to 112 fives 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.
Speaker Change: And metastatic breast cancer.
Similar to CLR 121225, we are preparing CLR 121125 for a phase <unk> 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 II dose. The study will include an imaging component to further <unk>.
Speaker Change: <unk> date, the bio distribution of CLR, one to 1125, providing crucial insights into its targeting and potential efficacy.
Speaker Change: 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 <unk>.
Speaker Change: Success in this area could be particularly particularly impactful given the limited treatment options currently available for triple negative breast cancer patients.
Speaker Change: We anticipate that positive data from this study could significantly enhance the value proposition of CLR 12115, and by extension our entire radiopharmaceutical platform.
Speaker Change: These trials represent a critical step in our pipeline development potentially positioning both CLR 121225, and CLR one to one once you put as groundbreaking therapies in the evolving landscape of targeted radiopharmaceuticals for cancer treatment.
Speaker Change: 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.
Speaker Change: Thank you Gerry as you can see we are off to a very good start in 2025 by rapidly secure and clarity on the fda's requirements for conditional approval under the accelerated approval pathway to state. The obvious this is a significant achievement.
Speaker Change: Asset value enhance as I previously reported we are in advanced discussions with multiple companies regarding the licensing rights for <unk>.
Speaker Change: The regulatory strategy established the FDA provides a clear and cost efficient regulatory pathway forward for pulp machine with what we believe to be limited clinical execution risk.
Speaker Change: The regulatory clarity has significantly enhanced the value of <unk>.
Speaker Change: Non dilutive cash associated with these potential deals would be highly beneficial for the company and.
Speaker Change: In addition, we will be prepared to initiate phase one studies for both the Alpha Actinium based radio conjugate in pancreatic cancer and the <unk> 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 assessing timing for the initiation of our phase one assets.
Speaker Change: Before opening the call to your questions I would like to thank our dedicated and talented select our team who continue to work with tremendous determination to move these important programs in the company forward.
Speaker Change: We remain committed to Wm community I sincerely appreciate the abundance of support and continued encouragement to advance <unk> to market.
Speaker Change: Together, we continue to push the boundaries of what is possible in oncology and we look forward to the future with optimism.
Speaker Change: Yes.
Speaker Change: Operator, we are ready to open the call to questions.
Speaker Change: Thank you, ladies and gentlemen, I will now conduct a question and answer session. If you have a question. Please press the star key followed by one on your thoughts Jon Cohen.
Speaker Change: You will hear a one.
Speaker Change: Solid January quest to your questions will be pulled in or their with their disease.
Speaker Change: If you would like to take place from the polling process. Please press the pound key.
Speaker Change: One moment for your questions. Please.
Speaker Change: Okay.
Speaker Change: Our first question comes from the line of Jeff Jones from Oppenheimer. Your line is open.
Speaker Change: Thanks for the update this is Larry I'll start Jeff.
Speaker Change:
Speaker Change: Okay, Great question I'm sorry.
Satcom for Io.
Speaker Change: 131.
Speaker Change: Sure.
Speaker Change: And our data from the complementary study or just a call back.
Speaker Change: Yes.
Speaker Change: And now have a follow up thanks.
Speaker Change: Sorry.
Speaker Change: You were breaking up there pretty bad so I am not 100% sure I captured everything that you.
Speaker Change: We were trying to question was the question.
Speaker Change: For the NDA submission does it require data from the news from a new study or is it just from the <unk> study.
Speaker Change: Yes.
Speaker Change: Yes.
Speaker Change: Captain require the.
Data from the complementary study or just yet.
Robert: Robert QUADRA study.
Robert: Yes, the accelerated approval will require data from the additional study as well.
Robert: Got it thanks.
Robert: So can you share the time line for patients to achieve and validated before.
Robert: Our response on that.
Robert: At self pay the study design.
Jim Caruso: Certainly this is Jim before I turn turn that question over to <unk>.
Robert: Jared.
Robert: We do anticipate rapid enrollment in this study based on our obviously the drug's performance and now the phase two.
Where we achieved outstanding clinical results and quite frankly, a very impressive adverse event profile as well.
Robert: Wm community was very disappointed that there would be a delay to market for iron pulp machine.
Robert: There's clearly high unmet medical need there.
Robert: 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.
Robert: Also disappointed that theyre not going to have this drug available in the very near term for their patients having said that it's very clear.
Robert: That the health care community would rally around the clinical study and we expect the enrollment quite frankly very quickly.
And from first patient and.
Jared Law: Crafted some time at events that we believe are conservative and I'll turn this over to Jarrett to provide some detail around this.
Speaker Change: As Jim said.
Jared Law: We took a conservative sort of approach to building our timelines here.
Speaker Change: And from that perspective.
Speaker Change: We look at it from first patient enrolled 8-K first patient dose that it would be approximately 24 months to full enrollment.
Speaker Change: And then with the two major response rate bids approximately 30 days that it would basically be one more months to achieve the necessary outcomes or major response rate.
Speaker Change: Great very helpful. Thank you.
Speaker Change: And what would be the comparator.
Speaker Change: Any color on the Paragon.
Okay. Thanks.
Speaker Change: We're particularly excited about.
Speaker Change: 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.
Speaker Change: And our thought leaders and Advisory Council I believe we have very limited clinical risk here.
Eric: Eric Yes.
Speaker Change: I would add to that.
Speaker Change: We believe or we know that at least one of the comparator is as we mentioned it will be two comparator.
Speaker Change: It's an investigator choice study design, so they get instead of one of the nine and the CCN guideline options they get to two options to choose from.
What 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.
Speaker Change: Obviously, the most relevant data comes from the innovate study using Rituximab mono therapy, 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 mono therapy it was 22%.
Speaker Change: Progression free survival median progression free survival around six months.
Speaker Change: 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.
Speaker Change: Believe it will be a rituximab combination treatment, where the expectation is it will perform very similar to the rituximab mono therapy.
Speaker Change: And for clarity.
Both the treatments.
Speaker Change: I will sum to 100 patients.
Speaker Change: Great. Thanks.
Speaker Change: If you don't mind I have a one follow up.
Speaker Change: Our financial runway of cash to fourth quarter this year.
Speaker Change: Include the work to complete IMD filing for CLR, one tier one could you comment on that one too.
Speaker Change: What about the studies themselves former Whidbey estimated costs of those phase one studies. Thank you so much.
Speaker Change: Sure.
Speaker Change: Go right ahead.
Speaker Change: So.
Speaker Change: The answer to your question is yes that runway does include the cost for the IND.
Speaker Change: Fillings.
And it causes as well.
Speaker Change: Relatively modest to get the phase one trials running and that is also encompassed in the cash runway that we presented earlier.
Speaker Change: And the costs associated with each of those studies is in the ballpark of about $4 $5 million.
Speaker Change: Great. Thank you so much.
Speaker Change: Okay.
Speaker Change: Thank you.
Speaker Change: Our next question comes from the line of Jonathan Aschoff from Roth. Your line is open.
Jonathan Aschoff: Hi, good morning. Thanks.
Jonathan Aschoff: Congrats on the progress and I was just curious the comparator arm.
Jonathan Aschoff: It's pretty much going to be 50, 51 group, taking rituximab and the other one taken something else among those nine end CCN drugs is that correct.
No that is not correct, Jonathan so they only get to choose what if theres only two choices right. One will be rituximab, one will be the other the other arm that we're agreeing to with the FDA, we have to provide them with.
Speaker Change: Utilization data on our other choice, that's what they want to see.
Speaker Change: How that breaks down.
Speaker Change: <unk>.
Speaker Change: No it's not that it's not a 50 50 right the physicians get to choose it could be 90% of it talks about monotherapy and 10%. The other arm. We don't know we don't have any control over that so it's a 100% and investigator choice between two options.
Speaker Change: That's that's helpful. Do you wish to allow us to understand that all the range of deal types youre entertaining for $1 31 to get that trial started.
Speaker Change: Again, we're obviously, we're very fortunate right we have a.
Speaker Change: Phase three ready oncology asset <unk>.
Area with high unmet medical need with a substantial market both here and abroad with the opportunity for orphan drug pricing.
Speaker Change: In our space with very very limited treatment options and likely.
Speaker Change: One of the next one or two radio therapeutics 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.
Speaker Change: As I cited in my.
Speaker Change: Remarks that the clarity on the regulatory side has been very well received and I believe.
Speaker Change: Those entities that are reviewing the asset.
Speaker Change: Also view this as very very limited clinical risk.
Speaker Change: So you have a pretty much a clear pathway to approval with very low risk.
Speaker Change: Not achieving.
Speaker Change: The necessary results versus the comparator arms at Jared just cited earlier so those deals could take on a number of different looks all have jarrett talk to some broadly or generally some of the types of deals that we would entertain.
Speaker Change: So to your point, Jonathan I think we've talked about this in the past.
Speaker Change: We're entertaining everything from.
Speaker Change: Global partnerships, where someone would take over obviously the global rights and we will continue to collaborate with them on on.
Speaker Change: Execution.
Speaker Change: But they would be predominantly responsible for everything and then they would be.
Speaker Change: Responsible for the commercialization of our compound afterwards.
Speaker Change: All the way down to regional rights, where it might be a European partner or work in Asia partner, and we would still maintain the U S rights.
Speaker Change: And proceeds from that perspective, we do have a number of quite as Jim alluded to we have a number of parties and we have parties in each of those buckets that have that are progressing their process 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 Change: And from a global licensing perspective.
Jonathan Aschoff: Just for some clarity Jonathan from a global licensing perspective.
Speaker Change: That would include a typical upfront payment series of milestones and royalties back to our company and then to the entity.
Put aside those rights too would also be fully responsible for the economics associated with the <unk>.
Speaker Change: With the pivotal study and the responsibility for the execution of it as Jarrett mentioned based on our relationships that had been established and our experience in executing the phase two.
Speaker Change: And with those known contacts with institutions and community based systems that will drive the majority of those patients both gear and ex U S that.
Speaker Change: That will be some additional value that we would bring to add additional way.
Speaker Change: And importantly, all of the CMC related costs and manufacturing costs would also be.
Speaker Change: Responsibility of a third party we would.
Speaker Change: Obviously because of our experience here and.
Speaker Change: And what we believe best in class Radiotherapeutic manufacturer language, we would be responsible for the manufacturing of the drug.
Speaker Change: Okay, Thanks, and lastly.
Why pancreatic for 225 is that based mostly on market need or was there some clearly differential preclinical efficacy signal.
Jonathan Aschoff: Yes, so yes actually Jonathan.
Jonathan Aschoff: The easy answer is yes, both actually so clearly the market need.
Jonathan Aschoff: It is significant there.
Jonathan Aschoff: And patients are in severe need of a new treatment paradigm, particularly for <unk>.
Jonathan Aschoff: Pancreatic ductal adenocarcinoma.
Jonathan Aschoff: <unk>.
Jonathan Aschoff: The addition to that as every preclinical model that we've tested of P deck.
Jonathan Aschoff: The Actinium program has done an incredible job of being highly effective.
Jonathan Aschoff: In every animal model of MTV reproduce that now.
Jonathan Aschoff: 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 light.
Jonathan Aschoff: <unk>.
Jonathan Aschoff: Therapeutic activity will be in a therapeutic window based off the safety profile.
Attractive natures of both of these phase ones is that Jarrett will orchestrate. This in such a way where we will receive dosimetry data on patient. So we will very rapidly see the amount of drug that's targeted to the tumor.
Jonathan Aschoff: And also within six to nine patients or so have a really good understanding of safety associated with this as well so it's not a <unk>.
Jonathan Aschoff: Long pathway to valuation we believe both of these tumor types are clearly higher medical need and very large markets.
Jonathan Aschoff: Also high unmet medical need and.
Jonathan Aschoff: And on the radio therapeutic side of the equation the 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 <unk> and a significant amount of preclinical work and obviously.
Jonathan Aschoff: All the work we've done on the imaging and diagnostic side of the equation.
Jonathan Aschoff: Our targeting platform is unique and will be able to deliver.
Jonathan Aschoff: The isotope regardless of the isotope too.
Jonathan Aschoff: To the tumor uptake as well as the associated safety that we observed with <unk>.
Thanks, a lot and I'm glad you guys are having the inbound.
Jonathan Aschoff: All right Jonathan. Thank you, we'll see you next week at your conference. Thank you for the invitation.
Jonathan Aschoff: Hi.
Jonathan Aschoff: Again, if you would like to ask a question. Please press Star then the number one on your telephone keypad.
Jonathan Aschoff: Yes.
Jonathan Aschoff: Okay.
Jonathan Aschoff: Yes.
Okay.
Speaker Change: There are no further question at this time Mr. Caruso. Please go ahead.
Sure. Thank you operator, and thank you everyone. This does conclude our call for today.
Speaker Change: Obviously take this opportunity to disconnect and please have an enjoyable day. Thank you.
Speaker Change: Ladies and gentlemen, this concludes the conference call for today. Thank you for participating please disconnect your lines.
Speaker Change: Yes.
Speaker Change: Okay.
Speaker Change: Okay.
Speaker Change: Okay.
Speaker Change: Okay.
Speaker Change: Sure.
Speaker Change: Okay.
Speaker Change: Sure.