Hello, welcome to the Fusion conference call. All participants will be in listen-only mode. Should you need assistance, please signal a conference specialist by pressing the star key followed by zero. After today's presentation, there will be an opportunity to ask questions. To ask a question, you may press star then 1 on your telephone keypad. To withdraw your question, please press star then two. Please note, this event is being recorded. I would now like to turn the conference over to Amanda Cray, Head Investor Relations and Corporate Communications. Amanda, please go ahead. Thank you, MJ. Thank you all for joining today's call. Please note that we have slides we'll be referring to posted in the Events and Presentation section of the Fusion website. With us from management on the call today are Chief Executive Officer John Valliant, Chief Financial Officer John Crowley, Chief Medical Officer Dmitri Bobilev, Chief Technology Officer Eric Burak, Chief Scientific Officer Chris Leamon, and President and Chief Business Officer Mohit Rawat. In addition, we're pleased to welcome to the call Dr. Oliver Sartor, Laborde Professor for Cancer Research, Medical Director of the Tulane Cancer Center, and Assistant Dean for Oncology at Tulane University School of Medicine. After our prepared remarks, we'll open the call for questions. During today's call, we will be making a number of forward-looking statements based on current beliefs and expectations. Our actual results may differ materially from such statements. Descriptions of the risks and uncertainties associated with Fusion's business are included in our SEC filings, which can be accessed either on our website or at sec.gov. With that, I'll turn the call over to John Valliant. Thanks, Amanda. Good afternoon, everyone. Turning to slide three, we are pleased to update you today on this exciting opportunity to expand our pipeline of targeted alpha therapies with actinium-225 PSMA I&T, a phase II asset with established proof of concept. We believe our acquisition of the IND for the phase II TATCIST trial positions Fusion to be a first to market with an actinium-based PSMA-targeted radiopharmaceutical that has strong potential to address a significant unmet need for patients and to become a near-term value driver for Fusion. To date, actinium supply constraints have largely hindered the development of actinium-based therapies, preventing them from reaching later-stage trials and commercialization. Given our existing investments in actinium sourcing and supply chain infrastructure, we believe Fusion is uniquely positioned to overcome this barrier and advance agents like actinium PSMA I&T through clinical development. Notably, there are similarities to the path that Endocyte took to acquire and develop lutetium PSMA-617, which became Pluvicto. Our conviction for the opportunity results in part from existing data from various investigator-sponsored studies in over 250 patients would show that, like in the image here, patients who are refractory to beta-emitting radioligand therapies or who relapse following therapy can respond well to the corresponding actinium-based treatment. Actinium PSMA I&T has also shown a high rate of response in patients who are naive to lutetium-based PSMA treatments. Thus far, the preliminary TATCIST clinical data in 10 patients are consistent with the data in the literature. I am also pleased to announce that concurrent with this transaction, Fusion has closed a private placement for $60 million with a syndicate of top-tier healthcare investors. Before we walk you through the details and existing clinical data from the ongoing TATCIST study, I'll turn it over to Dr. Oliver Sartor to discuss the opportunity for an alpha-based therapy to address unmet need for patients. Dr. Sartor. Great. Thank you very much, John. I'm Dr. Oliver Sartor, professor down at Tulane University and a longtime researcher in prostate cancer and radiopharmaceuticals. Next slide. If you look at the PSMA molecule, you have an unequivocal validated target. We have Pluvicto, we also have a whole panoply of other studies that have extended over time, typically done in the German setting, where there's the opportunity to give some of these radiopharmaceuticals for compassionate care. If we look on the right-hand side of the slide, we'll see the PSMA radiotherapies that are in clinical trials. What you'll see is a whole variety of the beta particles that have been moving forward fairly well, including the FDA approval for PSMA-617 from Novartis, and that's Pluvicto. When you look at the alphas, you're going to see that there's relatively poor development overall. The J591 antibody is an interesting antibody, and it is currently with Tulane University, although arrangements have been made for a company called Convergent Therapeutics. When you look at the PSMA I&T being able to assume the IND from Exelixis, you see that the phase II is gonna jumpstart the efforts at Fusion, and I think this is an important step forward. Next slide. There are two PSMA ligands that are in advanced clinical trial. These are the PSMA-617 and the PSMA I&T. The Fusion acquisition is for the PSMA I&T molecule, which has been well established. If you look at the top right-hand part of the slide, you'll see the beta emitters. Lutetium is the one that we know the most about. Relatively low energy beta. If you look at the actinium, these are the alpha-emitting radioisotopes, and it's a little bit deceptive when you see the maximum energy in the MeVs, and these are much, much higher than the betas. You also have to realize that there are four alphas from the actinium-225 and a 10-day half-life. The preliminary data on the PSMA I&T with actinium is strong, but I'll not be showing it here. If we look at the PSMA lutetium, and this is from the VISION study, the pivotal study for the approval of Pluvicto, you can see an overall survival benefit, and you can also see a benefit in the radiographic progression-free survival. You'll also notice that there's an unmet need because these individuals are certainly going to continue to progress. Even though Pluvicto is clearly active, there's an opportunity now for the post-Pluvicto space to be explored. When you ask, and again on the next slide here, you'll see the betas are part of the important treatment paradigm today. What do we do when those patients progress? This is a new unmet need and one that I think is going to be very important. One thing about the Pluvicto you may or may not have seen is that the pre-chemotherapy trial called PSMAfore has had a press release that announced its positivity for the primary endpoint, which is RPFS. The data will be presented at a future scientific meeting. Pluvicto is no longer going to be in the post-chemotherapy space. We anticipate it'll move into the pre-chemotherapy space, thereby enlarging the need for the post-Pluvicto patient. Next slide. I personally became intrigued with the alpha particles after seeing this particular presentation from Heidelberg, and in fact, as I went to the University of Heidelberg and met with the researchers there to better understand exactly what they were doing. Actinium-225, when given as ninth line of therapy, is capable of inducing responses that elicit wows when shown to our scientists. In addition, you can look at this patient on the next slide, who is a post-lutetium failure. Unequivocal progression, as measured by PSMA PET scans, measured by PSA, and then responding dramatically to the addition of PSMA actinium in this particular slide. Next slide. I don't want to go through all the individual studies. These are predominantly from 617 in various settings of metastatic CRPC. If you look carefully, the majority of these patients in most of the series have had prior novel hormones such as abiraterone and enzalutamide and chemotherapy. It turns out that some of these had radium as well. If you go to a relatively naive population from Mike Sathekge down in Pretoria, which is actually the largest series of 73 patients, see the PSA decline rates about 50%, median overall survival about 18%. These are very good results, not just the individual patients you might see in a photo, but actually looking at clinical trials. Next slide. In summary, there's no question in my mind that PSMA represents a validated target for prostate cancer therapeutics. That's a fact. It's also a fact that the VISION study with PSMA-617 lutetium represented a pivotal step forward, and this agent is now approved. The patients progressing after lutetium represent a new unmet need, and as we go to the PSMAfore studies, as I alluded to earlier, this unmet need is only going to be growing. I think with Fusion taking over the TATCIST trial with PSMA I&T and having the ability to deliver actinium, the ability to acquire actinium, I think this is going to be an important step forward and potentially even involving earlier lines of therapy, not just to post-Pluvicto, but nevertheless, this is an important step forward to be able to look at actinium being commercialized in the context of PSMA binding ligands. Thank you very much. Thank you, Oliver. Turning to slide 13. As I mentioned, there's an established roadmap for PSMA-targeted radioligand therapies based upon the Endocyte experience with lutetium PSMA-617, which ultimately became Pluvicto. Endocyte took over a Phase II IND, coincidentally from the same investigator from whom we have acquired this IND, and subsequently initiated the VISION trial. Ultimately, Novartis acquired the asset and commercially launched the drug. That drug was approved in a post-chemotherapy setting, and recent updates from Novartis state it could likely move into a pre-chemo setting. Current estimates indicate it could achieve $3 billion in annual sales by 2028. Turning to slide 14. Alpha-emitting medical isotopes like actinium-225, used in place of beta-emitting isotopes like lutetium-177 in PSMA-targeted radioligand therapies are emerging as potentially more potent next-generation therapies. Alpha particles deposit a tremendous amount of energy over a short distance, creating the opportunity to be more potent and precise than betas. At Fusion, we've been keen on alpha emitters from the outset and have our platform technology around actinium for a few reasons. At the same dose, alpha particles cause greater physical damage to cancer cells than beta particles, including multiple direct double-strand DNA breaks, which are highly lethal. Alpha particles are larger and have higher linear energy transfer rates than beta particles. They deposit a greater amount of tumor killing energy over a short distance of one to 3three cells compared to the relatively long distance of up to 12 millimeters for beta particles, allowing alpha particles to cause damage to cancer cells in close proximity while reducing off-target radiation risk. Based on the physical damage to the cancer cells, we believe that alphas also elicit a stronger antitumor immune response, which is supported by our previously reported work using combinations of checkpoint inhibitors and targeted alpha therapies. Additional data is emerging not just in prostate cancer, but also other cancer types, showing the value of alphas over betas. Given the potency and the precision of the alpha, we believe pursuing a validated target such as PSMA with an actinium-based agent represents a significant opportunity. Moving now to slide 15. There have been multiple investigator-sponsored studies supporting the potential of actinium-based PSMA agents, specifically actinium PSMA-617 and actinium PSMA I&T, which are based off the same basic core molecule that binds PSMA. There are over 250 patients treated, including approximately 100 patients post-treatment with lutetium-based PSMA agents. There is compelling efficacy data from these studies in both lutetium PSMA-naive and post-lutetium PSMA treatment, and the safety results are supportive of developability. Dmitri will further expand on this data in his remarks. Despite the opportunity to be best in class, as I noted previously, it has been access to actinium that has been a major barrier to advancement of this class of therapies. This is again why we feel Fusion is well-positioned to execute on this opportunity. Turning to slide 16. As you may know, Fusion was spun out of the CPDC, a radiopharmaceutical manufacturing center of excellence that I founded and ran for over a decade. Radiopharmaceutical manufacturing and supply chain expertise is a part of our roots. It is something we have been planning for and investing in since day one at Fusion. With the growing number of companies we see moving towards developing actinium-based therapies, we expect the actinium supply shortage to persist. We are well-positioned given the early steps we took to secure supply. We have historically received our actinium from the U.S. Department of Energy, and while adequate for our current scale, their production capacity from the actinium generators for new orders is limited. We have signed strategic partnerships and supply agreements with TRIUMF, Niowave, and most recently with BWXT Medical, one of the largest commercial scale medical isotope manufacturers. Each of these groups have produced actinium that we have received and tested. We expect each of these groups to continue to scale their production of actinium. These agreements are not just basic supply agreements. They provide preferential access and, as noted, the ability to scale production to meet our future needs. Fusion has deep internal expertise and experience with manufacturing actinium-based radiopharmaceuticals. We have tech transferred multiple clinical stage programs to leading CDMOs. Foreseeing the growth of our pipeline, including programs emerging from our collaboration with AstraZeneca, we initiated and are nearing completion of construction of our own GMP manufacturing facility, which we expect to be fully operational in 2024. The facility will add commercial scale capacity to our existing contract manufacturers and create a diversified manufacturing base that can scale as needed. Redundancy in supply chain versus consolidating at a single site and the ability to flex your production capacities is critical in this space, particularly as we move into advanced trials and eventual commercial scale production. Given these investments, we feel we have the skills, the infrastructure and expertise to be first to market with an actinium-based PSMA agent. Looking at the landscape of actinium PSMA trials on slide 17. There are several companies developing PSMA agents based on beta emitting isotopes, we feel the alpha emitting forms are differentiated. To our knowledge, the TATCIST trial is the only phase II study and is the most advanced actinium PSMA clinical trial. Novartis has an actinium-based PSMA program with no U.S. IND and a small number of sites open outside the U.S. The Convergent program is based on the long-studied antibody J591. The bulk of other actinium PSMA development candidates are preclinical. By taking over the ongoing Phase II IND for TATCIST, we believe there's an opportunity to be first to market, mirroring the approach that benefited Endocyte and then Novartis with Pluvicto. I'll turn it over to Dmitri to talk about the TATCIST trial and existing data to date. Thank you, John. Turning to slide 18. As John described, we are taking over the phase II TATCIST study. This study is enrolling metastatic castration-resistant prostate cancer patients who have progressed on at least one line of chemotherapy or who have declined therapy with taxanes. The patients may or may not have received prior treatment with lutetium-based PSMA agent, and they are required to have a positive PSMA scan and lesions with SUV greater than two. As it is currently designed, we expect to enroll approximately 100 patients into the study, dosing every eight weeks up to the maximum four cycles per patient. The starting dose will be 100 kBq per kg with a possible de-escalation to a lower dose if necessary, and it will depend on the decline in PSA and safety profile. De-escalation has been shown to help manage side effects and particularly xerostomia. Patients will be evaluated for the rate and depth of PSA decline, radiographic response, and changes in SUV and PSMA PET. One significant advantage of the program is that we are moving immediately into an active phase II study, with 10 patients already enrolled in treatment. Upon completion, this program will serve as the basis for the end of phase II meeting with FDA to inform registration phase III study design. In this study, we have the opportunity to treat a growing patient population with high unmet need, including those who have previously been treated with lutetium-based PSMA agents and also those who have had no prior PSMA radioligand therapy. Turning to slide 19. The proof of concept for actinium-based PSMA radioligands has been established in more than 250 patients with metastatic castration-resistant prostate cancer, approximately 100 of whom were lutetium PSMA-treated patients. As you can see on the slide, actinium PSMA I&T is active in those patients who progressed on or after lutetium PSMA radioligand therapy. The image on the left shows significant PSA decline in 14 patients, 11 of whom were previously treated with lutetium PSMA, and is an example of decrease in PSMA uptake corresponding to PSA decline in a patient who progressed on lutetium PSMA. The results were similar with actinium PSMA-617, shown on the right. Thus far, the TATCIST preliminary results are in line with the 250 patients with established data from investigator-sponsored studies. Turning to slide 20. I'll review the existing preliminary data from the ongoing TATCIST study. A heterogeneous group of 10 heavily pre-treated patients but lutetium treatment-naive patients were enrolled and treated in the TATCIST study to date, and they are in various stages of treatment. We plan to prioritize enrollment for lutetium PSMA-treated patients in the future for current protocol. In this preliminary look into emerging data in the ongoing study, 10 patients have at least one post-baseline PSA value, and some of those patients didn't reach the 8-week evaluation point. The PSA 50 response was observed in four of the first eight patients who reached the 8-week evaluation point, and it corresponds to PSA 50 response rate at eight weeks of 50%. This number reflects patients who may also have progressed early in dosing but who may still be continuing therapy. For reference, the PSA 50 response rate for Pluvicto in VISION study was 46%. Looking at radiographic response, there are seven patients who are resistant variable. In these patients available for best response, we have one complete response, two partial responses of which one was unconfirmed, and three patients with stable disease and one patient with progressive disease. PSMA PET is also used as an additional measure of evaluation. Five patients were available for PSMA PET response at the time of data cut. One had complete response, two had partial response with more than 30% decline in SUV, and two patients had stable disease with less than 30% decline in SUV. The PSMA PET scan image of the patient with complete response is shown in the middle panel, and all the visible lesions have disappeared on PSMA scan. This patient had a PSA of approximately 1,100 at baseline and currently is at approximately two upon completion of the treatment program. This is a very encouraging result for a patient with such a high tumor burden. Turning attention to the colored spider plot. You will notice some patients achieve a significant PSA decline of more than 50% and more than 80% associated with long duration of reduced PSA level. In other patients, PSA level increased rapidly. It is important to note that this is investigator-sponsored study, which is enrolling patients who have received multiple lines of prior therapy, including novel anti-androgens, taxane, and radium-223, and includes some patients with ECOG performance status 2 and liver metastasis. For reference, in the VISION study of Pluvicto, patients with poor performance status and liver metastasis were only a very small proportion, less than 10% of the entire study population. Among those patients who showed rapid progression, two had ECOG performance status 2, which is a known poor prognostic factor. Importantly, the TATCIST study was amended in December to exclude these type of patients going forward. In terms of safety profile, see the table of adverse events observed to date. As expected, xerostomia was observed in the majority of patients. Out of nine evaluable patients, seven had grade one xerostomia, and one patient had grade two xerostomia. Also present were dysgeusia, changes in taste, as well as dry eye and decrease in blood counts. These are all known and expected side effects of PSMA targeted radioligand therapy. No patients discontinued the study treatment due to xerostomia. Three patients experienced grade three anemia. Of them, two patients also had grade three and grade four thrombocytopenia, which were reported as serious adverse events. One patient had anemia and grade three thrombocytopenia, which are noted as potentially unrelated to therapy as a result of patient extended disease in general status. The investigator is still evaluating the attribution to study drug, which is to be determined. An important note regarding the patient with grade four thrombocytopenia is that he entered the study with pre-existing decreased blood count, which should have made this patient ineligible for the study. As stated earlier, these data are simply an early snapshot based on 10 patients, some of whom have not yet completed their course of treatment. This is also a heavily pre-treated population, with patients having received between four to seven lines of therapy, including chemotherapy and abiraterone. With these caveats, the data are consistent with a larger data set of 250 patients reported in the literature on actinium PSMA and support the potential and developability of actinium PSMA IND. Moving to slide 21. We provide more detail on some of the recent changes made to the study and changes that will be implemented upon Fusion initiation of activities. In particular, according to the protocol amendment made in December, patients with poor performance status and liver metastasis will no longer be eligible for the study. Moreover, as Fusion takes over the study, there will be tighter control on patient selection. To go to slide 22, I will review the next steps and the development strategy. Upon taking over the IND, we plan to expand the number of study sites to accelerate patient enrollment. We will prioritize patients previously treated with lutetium PSMA, as we are planning for the first registration study to be conducted in a post-lutetium population. This allow us to address the expected growth in the number of patients treated with this agent. The plan is to enroll a total approximately 60 patients who progressed on or after lutetium PSMA therapy and 40 who are lutetium PSMA naive. We expect that in approximately 12 months we will report preliminary safety and efficacy results for 20 to 30 patients. We expect that by the end of 2024 we will complete the phase II study and have an end of phase II meeting with FDA so that we are in a position to move quickly into phase III study. I will turn over it to Mohit. Thanks, Dmitri. I will touch on the unmet need patient population and the opportunity on slide 23. As Oliver mentioned, the VISION study with lutetium PSMA-617, now referred to as Pluvicto, showed positive results for the ability to treat later stage metastatic castration-resistant prostate cancer. The PSA 50% response was less than 50%, and the radiographic ORR in patients with evaluable disease was less than 30%, there is a further opportunity and need to provide improved efficacy for patients. In the VISION study, about 37% of patients on Pluvicto went on to receive another therapy, there is a very clear unmet need, especially in the lutetium PSMA relapsed refractory population. There is no established standard of care post-lutetium, this population has one of the highest unmet needs in prostate cancer. The current Pluvicto label makes it third line plus therapy after at least one ARTA and at least one chemotherapy. Novartis recently announced that their pre-taxane study, PSMAfore, hit its primary endpoint, and they plan to file for submission in the pre-taxane setting in 2023. In addition, there are multiple additional late-stage lutetium-based PSMA trials ongoing. Why is this important? As lutetium PSMA treatments are expected to move up in the treatment paradigm, the pool of lutetium relapsed refractory patients is expected to grow. That's where we aim to come to the market with the first indication. Based upon current estimates, we believe in the U.S. alone, that could be a $500 million opportunity. In addition, we believe there are multiple opportunities for market expansion. First, we believe that actinium has the potential to be more potent and therefore more effective than lutetium agents. We have the opportunity as a second stage of our development plan to move into earlier lines of treatment and take on lutetium PSMA agents. Taking some share in earlier lines could present an additional $1 billion opportunity. If approved, Europe and rest of the world will be an additional upside. We also have issued combination IP on TATs with checkpoint inhibitors and have filed IP with DNA damage response inhibitors. There is a growing body of evidence that shows synergistic efficacy potential using lutetium PSMA agents with checkpoint inhibitors, most recently in the PRINCE trial combining Pluvicto and pembrolizumab. Combination therapy represents an exciting opportunity for market growth and further upside. In summary, if you take the most conservative estimates of the near term opportunity just in lutetium relapsed refractory patients, we believe it's significant. If we add the potential of going upline, combinations or outside the U.S., it substantially increases the potential value of the asset and the opportunity to address patients in need of treatment options. Turning to slide 24. To highlight the strength of the team we have assembled to execute on this opportunity to be the first actinium PSMA agent to reach the market. We have deep PSMA radiopharmaceutical, prostate cancer and oncology expertise across various functions. As you may know, coming from Endocyte, our Chief Scientific Officer, Chris Leamon, was a key figure in the successful development of lutetium PSMA-617, which became Pluvicto. Dmitry, who joined us recently as our Chief Medical Officer, has deep radiation oncology and prostate cancer clinical development expertise. John Valliant, our CEO, founded the CPDC, a radiopharmaceutical contract manufacturer, and brought deep radiopharmaceutical manufacturing and supply chain expertise to Fusion. In addition, we have substantial functional radiopharmaceutical and oncology expertise across actinium supply, regulatory, medical, and commercial. I want to note two additional key points that we feel provide us an advantage. First, from a clinical operations standpoint, we have brought in people who were involved in running the VISION trial. This opportunity is about speed and execution, and we have an experienced team who know how to run the TATCIST study and who know the key prostate cancer sites and investigators to get patients enrolled on this trial. Second, we have established a scientific advisory board consisting of the top KOLs, including Dr. Sartor. We have received their input to optimize the development plan, and we will continue to receive their guidance as we drive forward the development of this program. We believe this team and the cross-functional expertise supports our ability to bring the first actinium PSMA agent to the market. On slide 25, I'll walk you through an overview of the IP status. As you might know, the lutetium version of PSMA I&T has been previously published and is not covered by a composition of matter patent. Heidelberg University owns a broad method of use patent covering actinium PSMA I&T. We've consulted with a leading biotech IP firm, and based on their assessment, we believe the patent is invalid given relevant prior published art. In conjunction with this announcement, we have filed an Inter Partes Review, or IPR, to invalidate the patent. Although our ability to be successful in this challenge is subject to the decision of the Patent Trial and Appeal Board, an IPR is a well-defined process and we estimate a final decision in 12-18 months. Our goal is to be first to market, which gives us 5-year market exclusivity. As noted by John, one of our biggest competitive advantages is actinium supply and to be able to conduct large-scale clinical studies which will further strengthen our leadership position in the space. We believe there is a high barrier to entry for radiopharmaceuticals, and we intend to continue to leverage our advantages in supply chain and manufacturing capabilities. We aim to further strengthen and build around our competitive lead by leveraging our combination therapy IP for TATS with checkpoint inhibitors and DDRIs. There is a growing body of evidence for TAT combinations with immunotherapy and DDRIs to generate synergistic efficacy and move upline in the treatment paradigm. We also have other strategies to further bolster the IP portfolio for this asset. With that, I'll turn it back to John Valliant to conclude. John? Thanks, Mohit. Turning to slide 26. We are excited about this program for a number of reasons that we outlined. Notably existing clinical data in 250 patients and established proof of concept in a well-defined patient population with treating physicians who are increasingly using radiopharmaceuticals as part of the treatment paradigm. The increasing sales of Pluvicto is one indicator of that growing use. The addition of actinium PSMA I&T bolsters our pipeline with a phase II program, adding to our diverse portfolio of innovative targeted alpha therapies. It also creates additional near-term data catalysts, supporting a steady cadence of clinical updates over the next 24 months, beginning with our FPI-1434 program next quarter. Finally, to summarize on slide 27, we are acquiring the IND for the TATCIST trial for very favorable terms, including a modest upfront payment, clinical and regulatory and sales milestones, and low single-digit royalties. We believe this asset allows us to capitalize on the infrastructure investments we've been making in actinium supply and manufacturing while leveraging the expertise of our team, a team which I believe is uniquely qualified to move this program forward quickly and efficiently. Most importantly, we believe that the potency and precision of an alpha emitter combined with an agent targeting PSMA, which we now refer to as FPI-2265, carries an opportunity to fill a significant unmet need for patients who are not adequately treated with currently available therapies. We are now happy to open the call up for questions. Operator? Thank you. We will now begin the question- and- answer session. To ask a question, you may press star then one on your telephone keypad. If you're using a speakerphone, please pick up your handset before pressing the keys. To withdraw your question, please press star then two. That all may have a turn, please limit yourself to one question and one follow-up, and if needed, please rejoin the queue. At this time, we will pause momentarily to assemble our roster. Today's first question comes from Faisal Khurshid with SVB Securities. Please go ahead. Hi, guys. Congrats on this update. I wanted to ask, what does the development path look like if you could provide a little more color around that? Specifically, do you see a possibility for an accelerated approval path in post-lutetium patients? Also, when could you be in a position to potentially initiate a pivotal study? Thank you. Maybe I'll ask Dmitry to handle that question. Sure. Thank you. As we presented, the current development plan for this asset is to pursue the possible vector population. As data first will be generated in non-randomized phase II study, we're planning expanding for registration into phase III randomized study. We believe that the best results of which we'll inform with the registration of this product will come from the, from the study with survival endpoint, this can be achieved in a randomized setting. Got it. Thank you. The next question comes from David Nierengarten with Wedbush Securities. Please go ahead. Hey, thanks for taking the question, and congrats on the deal. First, do you have the dose established with these first few patients? Are you going to be working on, you know, different dosing regimens in your phase II? A quick follow-up on the IP. Who holds that Heidelberg license? Is it Novartis now, or is it still the university? Thanks. Why don't we begin, Dmitri, with the dosing, and then, Mohit, I'll ask you to answer about the IP. Sure. The advantage of this program is that this is a phase II study. The TATCIST was initiated by an investigator with a submission of original phase II protocol, which already explained and described the recommended dose at kBq. The reason for this to be a successful submission for this IND is because there are multiple publications, and we described approximately 250 patients. They almost all were treated with 100 kBq, and there is overwhelming evidence of safety profile and activity at this dose level. We are taking this dose level. There are components of dose optimization in our study that we will implement. There is no need for exploration in phase I settings. Good. Yeah. On the IP, David, the IP is owned by Heidelberg University, to the best of our knowledge. We have been in communication with them. We are, of course, not privy to any non-public confidential information. Got it. Thank you. The next question comes from Nicole Germino with Truist Securities. Please go ahead. Hey, thanks for taking my question, and congrats on the deal as well. As you're thinking about extending the trial sites, will the focus be on U.S. sites only, or are you also looking to explore ex-U.S. sites? Can you just talk about the appetite for, you know, an actinium I&T therapy ex-U.S., and what are the push and pulls there? Sure. Dmitri, do you wanna speak to the sites for the phase II and then beyond? Yeah, absolutely. As we are getting ongoing phase II study, and the timelines that we shared here, preliminary assessment, that this program is going to be executed fairly quickly in order to inform end of phase II that will help us discussion for registration phase study with the FDA. We are planning to expand first of all in the U.S. for this phase II program. As soon as we have patients, obviously the next stage is going to go outside of the U.S. and explore additional sites and open additional sites into the phase III. Because of the rate of execution, we potentially have the best execution of the study if we stay in the U.S. However, we are considering going across the borders if needed. Thank you. The next question comes from Suji Jeong with Jefferies. Please go ahead. Hi, good afternoon. Thanks for taking my question. I have a couple of questions for the expert, Dr. Sartor. First, what do you see as the differentiation between actinium-225 J591, the monoclonal antibody versus PSMA I&T? Do you think that actinium-225 will show better efficacy versus lutetium? I'm asking from the context of, like, actinium-225 small molecule like PSMA-617 or I&T having a dose-limiting toxicity in terms of xerostomia. Do you think that might be a limiting factor for achieving higher efficacy versus lutetium? I have follow-ups. Thank you. Sure. There were a couple things sort of wrapped into there. Let's talk a little bit about the xerostomia. This is an interesting issue because it actually has been relatively poorly annotated. If you go to the German literature, you can see that there are limitations on xerostomia that are noted. However, if you actually look at the number of people who discontinued the therapy, it's very small. One of the things that I've learned a while back is that the German nuclear medicine community is not particularly proficient at assessing adverse events, and we learned that from the Pluvicto, where they severely limited the dose. When we had a little more experience, we were able to dose escalate quite safely. I'll simply say that xerostomia is an interesting issue and one that we can talk more about. Thus far it has not been dose limiting in the preliminary data acquired from the RadioMedix. Next question on the antibody. You know, if you look at the actual data from the antibody and actinium, it's extremely limited. You have a phase I trial that has been published, and it's a single-dose phase I trial. There's been no repetitive dosing to date that has been published. What I'll say about the monoclonal is, to date, we just don't have the same level of evidence that you can get with the small molecules. I'm gonna say that I think that 617 and I&T are gonna be pretty similar to one another. If you take the totality of the evidence that was presented, and that was part of the presentation here, what you see is an unequivocally active compound. What you see in the J591 is a single-dose phase I, and we just don't really know that much about it today. I think those are two major aspects of the question. Was there more that I can clarify? Yes, that's really helpful. Just one follow-up question to your comments about dose limiting toxicity for actinium. I noticed that the renal toxicity rate is slightly higher with actinium versus lutetium. Do you think that might affect you, especially for patients who are pre-chemo setting? Well, you know, to date, there's not been much in the way of renal toxicity. I think the concern is that there could develop long-term renal toxicity, and that's what others have been concerned about. In the short term, there really is no toxicity. I will say in the long term, there's no toxicity that's been noted to date, simply a concern. Typical for the radiopharmaceuticals, and this would be true for radium and true for Pluvicto, that the FDA would require some long-term registries and follow-ups to ensure that there would not be long-term issues. I'll simply say to date, they've not been present. I see. Great. Thank you. I have two more questions for the management team. First, I missed your plan for phase III program. Did you say you're gonna be doing in both naive and lutetium-experienced patients? Dmitri? Yeah. The registration program is going to be in patients who are lutetium treated. This is the highest unmet need, and this is what our plan is. There is a future potential that the drug will be applied in earlier stages population as well as combination treatment in different subsets of prostate cancer patients. The next question comes from Justin Walsh with Jones Trading. Please go ahead. Hi. Thanks for taking the question. It's great that you guys are arguably best positioned to meet the actinium-225 supply for a commercial and clinical asset. Can you maybe provide some more color on the current status of the supply in the context of multiple Fusion trials ongoing and hopefully a pivotal trial for the asset in the near future? Just sort of follow up on that. Similarly, being first to market would be great, but do you anticipate being able to meet the demand, particularly in the context of the strong initial Pluvicto launch we've seen? Thanks, Justin. I'll ask Eric to speak to that. Yeah. Good afternoon, Justin. As John indicated earlier, we continue to support all of our trials with our current supplies. Our current phase I studies are ongoing, and with our projected ramp-up of this new phase II trial, we expect to be able to meet all of those needs as well. In addition, we're currently building a supply with our partners. Programs with TRIUMF, BWXT, Niowave are all starting to produce research-grade materials, that they're expecting to grow over the coming term, so to supply this current phase II trial as well. In addition, we continue to work with the DOE to expand their use of actinium as well. We have multiple opportunities to bring in multiple sources of actinium for not only this trial but all of our portfolio. Got it. Maybe one very quick follow-up on that. just sort of wondering, some comment, 'cause a lot of people, as you just cited, a lot of people are working on improving the supply. I'm sort of wondering what you're thinking the window is where you guys have this advantage of the preferred actinium-225 supply before everyone else catches up. Thanks. You know, it's really tough to say, you know, a specific timeline. Right now, we're working very closely with our partners evaluating their supplies. As John said earlier, we continue to test their materials. We're working with them to set specifications. Our early advantage is just there, is helping work with them to help divine their supplies for our needs. Once again, it also gets back to our partnerships. We have preferred access. We have preferred pricing. We get our needs met generally first, that's one of the things we're excited about. The next question comes from Andy Hsieh with William Blair. Congratulations on the deal and the private placement. Thanks for taking our questions. I have a question about dosing. I think most people are familiar with, you know, six, seven GBq from the lutetium. I'm just wondering if there's any sort of, you know, kind of nuclear physics, kind of equation in terms of translating that into actinium, where you're using the 100 kBq. Just trying to understand how comfortable you are with the current dose. Sure. I mean, The potency of alphas being so much greater than that of betas, you tend to use orders of magnitude lower activity, but again because we have seen data on over 250 patients from the literature, including testing different doses, we feel very comfortable with the 100 kBq per kg and the strategy that we're using. Great. I have a follow-up for Dr. Soter, if you don't mind. There's been a lot of debate, at least in the investment community, about larger tumor burden versus smaller tumor burden and perhaps, you know, the beta emitters are better for the former versus the latter. I'm just curious about your take on that. Also, if you look at the Pluvicto clinical programs, I think they allowed for up to six doses for responders. Also curious about your take on, you know, whether four doses is enough versus what, you know, Novartis has pushed for. I mean, a couple of questions in there. You know, number one, the alphas and betas are really two different animals, and I think we've all heard the story about the betas being potentially better for the larger tumors and the alphas better for the smallers. The truth is, when you look at the responses that you see with the alphas, it is rather extraordinary. It doesn't matter whether the tumors are large or small. I don't know if you saw Matt's slide presentation, but you saw some very, very high volume tumors that were completely eradicated. I think the sort of alpha-beta, and size of tumor arguments may not be so strong after all, at least when it comes to the alphas. For the betas, I think there's a lot of questioning about the very small tumors that can be eradicated with betas. That's a story for the Pluvicto folks to answer. On the dosing regimen, you know, it turns out that if you look at the amount of doses that have typically been given for the 100 kBq per kg, it turns out that a lot of times you certainly do not need four and five and six doses as you did with the beta. You are correct with Pluvicto that the way the VISION trial was put together, you would be given four doses and then two more if your physician believed there was benefit, and the majority of patients actually received six. Here, I don't think that six is gonna be required. You simply have so much punch, so much higher linear energy transfer, and so much killing power, double-strand breakage with the alphas, that I just don't think you're gonna need the same number of doses. The next question is from David Martin with Bloom Burton. Please go ahead. Yes. Congratulations and thanks for taking my questions. Of the 250 patients that have been treated with an actinium, PSMA, thus far, how many of them have got the I&T base versus the J591, base TATs? Mohit, do you wanna take that question? Yeah. With PSMA I&T, it's been 15 patients. The rest out of the 250 that we are quoting here, the rest is from PSMA-617. J591 study was not included in that 250 patients, that's around 32. I would also like to note there's a recent publication that shows really the biodistribution and the PK across Lutetium version of PSMA-617 and PSMA I&T really showed the almost identical results. Okay. The 10 INTs that were presented today are phase II. I take it there were five patients treated in phase I, and they were all at the 100 dose. Were there responses in those patients? Just to clarify. There was no phase I. Sorry, David, just for clarification, there's no phase I involved. These are all patients from the phase II. Oh, they are. Okay. Okay. let's see. In 12 months, you said you'll have data for 20-30 patients. I may have missed it, but are you now focusing on lutetium failed patients? Dmitri, do you wanna answer? The study is positioned to enroll both types of patients. It is open for lutetium naive and lutetium treated, you are correct. The emphasis and the given our registration path and lutetium treated patients, the priority is going to enroll patients who were treated with lutetium in the study. The next question comes from Kemp Dolliver with Brookline Capital Markets. Please go ahead. Great. Thank you. The trial design as initially proposed would follow patients for up to 24 months. I mean, how quickly or how long do you expect you would follow patients to be able to meet the timeline to complete the study and go to phase III? Dmitri? The primary endpoint for the study is response rate at this point. We also have progression-free survival, and especially in patients with lutetium treated patients, we expect that the progression-free survival event will happen within a year. The overall survival and some safety follow-up is, we predict that it will be required for any FDA conversation, and it's going to be condition for us to generate as much data for long-term follow-up as possible, and this is why we have extended timeline. As we said, the preliminary results of the 20 to 30 patients will be expected within a year from now, and the study will be completed to satisfy for the provide enough information for the end of phase II treatment, we expect by the end of 2024. Great. Thank you. Just one financial question, that's the change in the runway guidance. Does that continue to include additional borrowing under the credit line or strictly reflects the additional capital you've raised? John? Hi, Kemp. No, that reflects strictly the capital that we raised. It does not consider any additional drawdown of our debt facility. The next question comes from Yuan Zhi from B. Riley Securities. Please go ahead. Thank you for taking our questions, and congratulations on this deal. Maybe, first one is for this assets from RadioMedix. Is it carrier-added or non-carrier-added actinium? Where does FDA stand of, treating these two forms? I have a follow-up questions. Eric, do you wanna answer that? Currently, RadioMedix is using the non-carrier-added, so containing no actinium-227. They're getting their material from the US Department of Energy. As in terms of where the FDA stands, the FDA hasn't come out publicly to state where they sit with that material. However, we have said in the past that we are under discussions with FDA to get their understanding of what it would take to move that material into clinical trials. Currently, we don't use the accelerator or actinium-227 containing material in our trials. We only use the non-carrier-added. We are under discussion with FDA to see what it would take to bring the carrier-added material into clinical trials. Got it. Thank you for the clarification. Can you perhaps clarify on why is the dosing interval here is about 8 weeks? What are the factors driving you to choose eight weeks instead of four weeks or six weeks? Dmitri? Yeah. The body of literature that we have presented was universally using 8-week intervals between treatment. It's historically been explored and demonstrated the safety. This was going to be our starting point of exploration. There are no other therapy regimen explored to date to our knowledge. Today's last question comes from Hangf ei Fu with Cowen. Please go ahead. Thank you for taking my question, congrats on the deal as well. Can you expand on the safety of this actinium PSMA I&T? More specifically, what are the radiation exposures to kidney and mucositis compared to beta PSMA agents? I have a follow-up question. Thank you. Dmitri? There is no direct measurement of exposure of organs at risk with actinium PSMA I&T available in the literature. The reason, unlike lutetium that can be measured using traditional dosimetry methods, actinium doesn't provide this degree of activity which is measurable. However, based on distribution, we consider that the safe levels will be achieved with the regimens that so far been established, which is 100 kBq per kg for four administration. Okay. Thank you. My next follow-up question is, POINT Biopharma is developing actinium PNT2001. In their view, the I&T was not good enough of targeting, and they showed in their clinical study that actinium PNT2001 had better efficacy and a reduced toxicity than actinium PSMA I&T. Anything you can comment on that? Appreciate. Chris, do you wanna comment there? Sure. Thanks for the question. We are aware of all of the compounds that POINT is currently exploring, as well as other groups. What POINT has disclosed is basically preclinical data. The attributes that they believe are positive for that are certainly borne out in animal studies. Translating that into the clinical outcome has yet to be obviously known. We have seen instances with various PSMA-based agents, certainly I have, I've been in this space for a while, where preclinical benefits do not translate at the clinical level. That can be whether it's salivary gland uptake or renal disparities of uptake. Actually, we just need to wait and see. This opportunity that we're discussing today is obviously well advanced, which is why we're pursuing it. We're in the best position for it. I think it's gonna take a some time before we understand POINT's preclinical asset, how that will compare. This concludes our question and answer session. I would like to turn the conference back over to Mr. John Valliant for any closing remarks. Thank you everyone for joining us today, and we look forward to updating you on our progress soon. Thank you. The conference has now concluded. 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