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spk09: Good day everyone and welcome to the Clinetics Pharmaceuticals Second Quarter 2024 Earnings Conference Call. At this time all participants are in a listen only mode. Later you will have the opportunity to ask questions during the question and answer session. You may register to ask a question at any time by pressing the star and one on your telephone keypad. You may withdraw yourself from the queue by pressing star two. Please note this call may be recorded. I'll be standing by should you need any assistance. It is now my pleasure to turn the program over to Gaia 3
spk04: DeWalker.
spk12: Thanks, operator. Hello everyone and welcome to Clinetics Earnings Call. Joining me today are Dr. Scott Struthers, Founding and Chief Executive Officer, Dr. Dana Sizzuti, Chief Medical and Development Officer, Jim Hazard, Chief Commercial Officer, and Mark Wilson, Chief Financial Officer. Also joining us for the Q&A portion of the call is Dr. Alan Krasner, Chief Endocrinologist. A press release announcing the Second Quarter 2024 financial results was issued today and is also available on our corporate website. We will be using slides for today's presentation that can be viewed on the investor relations section of the Clinetics website. As a reminder, we'll be making forward-looking statements and I invite you to learn more about the risks and uncertainties associated with these statements as disclosed in our SEC filing. Such forward-looking statements are not a guaranteed performance and the company's actual results could differ materially from those stated or implied in such statements due to risks and uncertainties associated with the company's business. These forward-looking statements are qualified in their entirety by the cautionary statements contained in today's news release, the company's other news releases and the Clinetics SEC filing, including its annual report on Form 10K. I would also like to specify that the content of this conference call contains time-sensitive information that's accurate only as of the date of this live broadcast, August 8th, 2024. Clinics, take no obligation to revise or update any forward-looking statements to select events or circumstances after the date of this conference call. With that, I'll hand the call over to Scott.
spk13: Thank you, Gayathri. Good afternoon, everyone, and thank you for joining us on our Second Quarter 2024 results call. I'll begin by spending a few moments summarizing our recent accomplishments. Then I'll hand the call over to Dr. Dana Pizzuti, our Chief Medical and Development Officer, who'll provide a regulatory update. Jim Hazard, our Chief Commercial Officer, will share our plans to bring our lead candidate Paltus team to patients. And Mark Wilson, our Chief Financial Officer, will wrap up with a thrilling financial update. The second quarter of 2024 was extremely productive for kinetics. The Endocrine Society Annual Meeting in June proved to be an impactful meeting for us. We were thrilled to share highly encouraging initial results from the ongoing Phase II studies of our second development candidate, etumelanet, in both congenital adrenal hyperplasia and Cushing's disease. These unprecedented data were very well received by the endocrinology community. This reinforced our already strong confidence in the potential of etumelanet to be a -in-class and -in-class agent in both indications. Patients need better therapeutic options, and we are committed to realizing etumelanet's full potential as a revolutionary new treatment paradigm for people suffering from CH and Cushing's disease. Kinetics team is working hard to move development of etumelanet forward in both indications and bring this potential therapy to
spk04: people around the world. We also presented data from Paltusatine's
spk13: Pathfinder Phase III acromegaly program at ENDO. A new analysis from Pathfinder I highlighted results from an exploratory analysis using patient-reported outcomes captured in the acromegaly symptom diary, or ASD. These data showed that patients on monthly standard of care injections, who are defined as biochemically controlled, actually have a higher chance of getting acromegaly treatment. Patients actually experience variability in symptom control. In contrast, once daily Paltusatine treatment was associated with stable biochemical control and low rates of breakthrough symptoms. Dana and Jim will speak more on our progress of bringing Paltusatine to patients, but I'm incredibly excited about its potential to transform the future
spk04: of
spk13: acromegaly treatment and to find a
spk04: new standard of care. Overall, our 2024 plans
spk13: remain on track. Our next steps this year include filing the Paltusatine NDA for acromegaly, engaging with regulators to align on the initiation of a Phase III program in carcinoid syndrome, completing the Phase II studies of ethylmolamate and CAH and Cushing's, and transitioning multiple new drug candidates from our discovery efforts into preclinical and IND-enabling development. Along these lines, we've continued to make meaningful progress in our early stage pipeline. First, we've identified a parathyroid hormone, or PTH, receptor antagonist development candidate for our hyperparathyroidism program. Preclinical data demonstrates that this candidate reduces both PTH and PTH-related protein-induced hypercalcemia in rodent models, and it possesses a favorable drug-like profile. This profile is likely consistent with -per-day dosing in humans. We've begun IND-enabling studies and anticipate filing an IND in 2025. We've also selected an SST3 agonist development candidate to explore a completely new mechanism for the treatment of autosomal dominant polycystic kidney disease, or ADPKD.
spk04: ADPKD... Excuse me.
spk13: Lost my place. ADPKD is one of the most common genetic diseases and affects over 140,000 people in the U.S. Preclinical data for this candidate are very promising, and we are pursuing options to advance this program to clinical studies, either with a partner or independently. Our discovery program for Graves disease, including thyroid eye disease and obesity, continue to make great progress, and we look forward to announcing optimized candidates for these programs in the near future. As a reminder, our pipeline also includes novel molecules and technologies that are being developed by our partners. For example, several years ago, we developed a novel non-peptide radiothera agnostic program that could be used in multiple oncology indications. With this, we created a company around the technology called Radionetics Oncology and entered into a collaboration and license agreement with the company. Radionetics announced on July 1st that it entered into a strategic relationship with Eli Lilly & Company. Under the terms of the agreement, Radionetics received $140 million upfront, and Lilly obtained a warrant for the exclusive right to purchase Radionetics for $1 billion. Chronetics currently owns approximately 25% of Radionetics. If Lilly were to exercise its right to purchase Radionetics, Chronetics would receive its pro rata share of the $1 billion purchase price. Chronetics is also entitled to single digit royalties and commercialization milestones for the three programs currently in development at Radionetics. We believe this transaction is a great validation of the strength of our discovery platform and has the potential to generate non-dilutive funding for Chronetics in the future.
spk04: We also have a partnership with Wood,
spk13: in which we license another one of our targeted somatospatin molecules to extend the lifespan and health span of dogs. The company, the entire company is hard at work executing our strategy to help more patients with endocrine-related diseases and to build long-term value for Chronetics shareholders. Lastly, as you may have seen in our press release, Mark, our Chief Financial Officer, will be leaving the company for personal reasons. The Chronetics executive team and board are grateful for Mark's contributions to the company as he has been an invaluable member of the Chronetics team since before the IPO. His leadership was instrumental in the success of all our public market activities which have put Chronetics on a strong financial footing. We have initiated a search for a successor, and Mark will remain in his current position until a successor is onboarded to ensure a seamless transition. With that, I'll hand it over to Dr. Dana Fazzuti to discuss our clinical and regulatory progress in more detail. Dana? Thank you, Scott.
spk11: I'll start with our lead candidate, Paltuzetine. As Scott just mentioned, we remain on track to submit our NDA for Paltuzetine in its first indication, acromegaly, this year. As we have discussed, the Phase III Pathfinder program was designed to evaluate the safety and efficacy of Paltuzetine for the treatment of a broad spectrum of patients with acromegaly. Based on the success of both Phase III Pathfinder studies, we intend to seek approval for all patients, including those switching from the standard of care injected SRLs to Paltuzetine as studied in Pathfinder I, and those who are not currently treated as studied in Pathfinder II. In parallel with our Phase III program, we have laid the foundation to streamline and accelerate the NDA filing. We have held two productive pre-NDA interactions with the FDA to align on clinical, non-clinical, CMC, and quality topics. The FDA confirmed that our proposed package support submission for both treatment and maintenance of acromegaly. This robust package includes data from our two Pathfinder Phase III studies, as well as dose response analyses, data from our long-term safety studies, and patient outcomes from the acromegaly symptom diary, which showed significant improvements in patient-reported symptoms in both of our studies. We look forward to updating you as we continue towards the NDA filing. In addition, we are diligently conducting health economics and outcome studies to further demonstrate the value proposition of Paltuzetine and acromegaly. This work supports the commercial team's efforts as they engage with payers, physicians, and patients. We are also making progress in Paltuzetine's second indication, carcinoid syndrome. As previously reported, our Phase II study showed highly statistically significant results demonstrating the potential of Paltuzetine to treat people living with carcinoid syndrome. Importantly, the patients who elected to participate in the ongoing open-label extension continue to benefit from Paltuzetine. Building on this success, we are preparing to discuss the Phase II results with the FDA and align on the design of a Phase III protocol. We expect to initiate the Phase III trial by the end of 2024. Turning now to Adam Melman, we are excited about the progress and potential of Adam Melman in both CAH and Cushing's disease. As Scott mentioned, the initial results from the open-label Phase II studies, which were featured at ENDO, have exceeded our expectations. The three cohorts evaluating different doses of Adam Melman in the CAH Phase II study are now fully enrolled. We anticipate additional data will be available this year, and we are excited to advance this program. We also expect to share additional data from the ongoing study in ACTH-dependent Cushing syndrome later this year. Prenetics is fundamentally committed to placing patients at the forefront of everything we do. This patient-centric approach is deeply ingrained in the development activities for each of the programs in our pipeline. We actively seek patient input throughout the drug development process. We've gained valuable insights by sharing data with patients, particularly from our Acromegaly program. These insights validate our commitment to developing treatments that improve patients' quality of life, such as offering convenient dosing regimens. We have also routinely partnered with patient advocacy groups to obtain patient input on clinical trial design. Patients are enthusiastic about the potential of palatuzitein, recognizing that it not only delivers the desired biochemical control, but can also improve the symptom of the burden associated with their condition. We invested considerable effort to develop the Acromegaly symptom diary and are supporting that with psychometric analyses to help document the impact of palatuzitein on patients' quality of life. The positive feedback we have received so far indicates that our patient-focused approach can help us develop better therapies that make a meaningful difference to patients. I'll now hand the call over to Jim to review commercial readiness strategy and current progress.
spk01: Thank you, Dana. For many years, Chronetics has been a committed member of the endocrinology community. We participated in many medical conferences and learned from countless listening sessions with both patients and healthcare providers alike. We're now on the verge of filing the palatuzitein NDA, an opportunity to establish a new standard of care in the treatment of Acromegaly for patients, healthcare practitioners, and payers. Acromegaly is the first indication for palatuzitein. Our launch preparation activities are laying the foundation of a fully integrated organization that can be leveraged for future indications, including carcinoid syndrome, as well as other drug candidates in our pipeline. Our overarching strategy is to disrupt the established Acromegaly marketplace, which is not seeing any new molecules in over a decade. We are bringing a clinically differentiated, once-daily oral medication to market with our commercial infrastructure and differentiated support services. Our commercial strategy is guided by three underlying pillars. First, extending kinetics partnership with healthcare practitioners. Second, empowering patients. And third, streamlining access to therapy. The first pillar is extending our partnership with the endocrinology community. We will be launching into a concentrated prescriber base of approximately 200 healthcare practitioners who are responsible for the vast majority of prescriptions. These providers can be reached with a small sales force of approximately 25 to 30 sales representatives in conjunction with other activities across the organization, including medical affairs. As we deepen our relationships with prescribers, we are building awareness of the patient experience and burden associated with the current standard of care. We've conducted multiple lines of market research, and one common theme is a disconnect between what physicians perceive and what their patients actually experience. For example, we found that endocrinologists believe two-thirds of their acromegaly patients on pharmacotherapy are well controlled biochemically and symptomatically. However, in our patient surveys, we found that 79% of acromegaly patients report breakthrough symptoms. Now, these are symptoms that often reemerge toward the end of their monthly treatment cycle. Patients have indicated that the treatment burden and breakthrough symptoms can be detrimental to their lives, but patients may not mention this during their physician appointments. So, if doctors aren't asking and patients aren't volunteering this information, the disconnect is not being addressed. Healthcare practitioners are always seeking the best treatment for their patients, and today they don't always have complete visibility into their patient's experience. We at Prenetics are dedicated to providing an option that addresses the limitations of the current standard of care. We want to bridge the frequent disconnect in dialogue and help healthcare practitioners become more aware of the patient experience, including the pain and challenges associated with intramuscular and deep subcutaneous injections and the breakthrough symptoms that can occur at the end of the somatostatin receptor ligand injection cycle. We believe paltucitin may provide a better treatment option for patients as it was designed to address the limitations of today's standard of care. Our commercial team has recently launched acromegalytruth.com, our disease awareness campaign for endocrinologists treating patients with acromegaly, which you can see on slide seven. More than 1,500 providers have already interacted with this site so far. Acromegalytruth.com includes perspectives from patients on injectable SRLs, including injection site reactions, GI side effects, breakthrough symptoms, and emotional impact of treatment. In addition, we believe that positive data from the Acromegaly Symptom Diary, which was one of the secondary endpoints used in the Pathfinder Phase III program, will help healthcare practitioners understand the clinical benefits of paltucitin, which go well beyond biochemical control. In fact, we have already shared some of this data from the Acromegaly Symptom Diary at ENDO this past June. We hope this data will help physicians understand the potential transformative impact of paltucitin for their patients. We already have strong relationships with academic key opinion leaders in the pituitary treatment centers. As another example of our commercial execution, we are looking to expand our relationship with endocrinologists in the community setting. To that end, we've assembled an initial team of thought leader liaisons who are in the field deepening our relationships with clinical endocrinologists who are managing patients day in and day out. The second pillar of our commercial plan is empowering patients to ask for better care and improved control of their symptoms. We recognize the vital role patients play in advocating for their diagnosis, managing their disease, and seeking optimal treatment. To this end, we plan to launch next year an expanded disease awareness campaign targeted towards patients with acromegaly. The goal is to help patients realize that better control of their acromegaly symptoms and the lower treatment burden may be possible. Ultimately, we want to empower patients to ask their health care practitioner for paltucitin once approved. As Dana mentioned, our patient advocacy team has been engaging with the acromegaly patient organizations since early in clinical development. We are continuing to strengthen our relationship with the patient community to ensure we are addressing the needs of patients. The third pillar of our commercial plan is to ensure optimal patient access to our best in class therapy. The national account team responsible for all payer interactions is in place and onboarded. We have had discussions with the top commercial and government payers covering the majority of lives in the country, and initial feedback from those payer advisory meetings has been encouraging. We are finalizing a highly differentiated patient support center to help streamline the prescribing, dispensing, and reimbursement process. This support center is being designed based on our ongoing market research and discussions with patients to develop best practices and close the gaps in the current reimbursement processes. We have also finalized our distribution channel. We look forward to sharing more details at our next earnings call. In addition to establishing the commercial foundation for a successful launch, our medical affairs team is engaging in robust scientific discussions throughout the medical community. We have hired Dr. Bob Cudahy, an experienced endocrinologist who has dedicated much of his time to the research of the clinical research team, and has built and led medical affairs functions at other organizations such as Janssen, Sanofi, and Amgen. In conclusion, Chronetics continues our evolution to ensure that we are in the best position to execute our launch strategy following approval. The data that have been generated to date puts us in a unique position to demonstrate a highly differentiated clinical profile across multiple dimensions, including biochemical control, symptom control, tolerability, and the overall patient experience. We know what is important to patients, to the physicians who treat them, and to the healthcare system. And we believe in the value proposition of Peltucetine, which serves each of these constituencies well. Over the coming months, leading up to the expected launch in 2025, we will continue to implement our commercial strategy and share updates along the way. I believe in the transformative potential of Peltucetine for patients with acromegaly, and I'm excited to be leading our commercial team to launch this therapy. We are laying the foundation for a fully integrated pharmaceutical company that will be prepared for future Peltucetine indications, as well as other products in the Chronetics pipeline. With that, I will now hand it over to Mark to review the financials. Thank you, Jim.
spk10: As Scott mentioned, I will be stepping down from my role as CFO at Chronetics for personal reasons. Chronetics is in very capable hands with its deep bench of leaders across the organization. I am proud of all we have accomplished during my tenure, and I look forward to the company's continued success as it evolves into a fully integrated endocrinology franchise. With that, I will now review the second quarter financial results. Chronetics continues to be in a strong financial position, having ended the second quarter with approximately $863 million in cash and investments. Our solid financial foundation is projected to fund our current operating plan into 2028. This includes plans to commercialize Peltucetine for acromegaly, the initiation of multiple later stage clinical trials and additional indications with Peltucetine and Entomelnet, as well as continued investment in our pipeline. With respect to the second quarter financial results, research and development expenses were $58.3 million for the quarter end of June 30, 2024, compared to $40.6 million for the same period in 2023. The increase was primarily attributable to higher personnel costs and manufacturing and development activities, both of which were driven by the advancement of our clinical programs and the expansion of our preclinical portfolio. For the quarter end of June 30, 2024, general and administrative expenses were $24.8 million compared to $13.3 million for the same period in 2023. The change was primarily due to an increase in personnel costs and an increase in outside services as we continue to build the infrastructure to support our growing pipeline. Net loss for the quarter end of June 30, 2024, was $74.1 million compared to a net loss of $51 million for the same period in 2023. Revenues were $0.4 million for the quarter end of June 30, compared to $1 million for the same period in 2023. Revenues during the current year's quarter were derived from the Peltucetine licensing arrangement with our Japanese partner, SKK. Net cash used for operating activities for the quarter end of June 30, 2024, was $45.6 million. We expect our cash burn to be approximately $50 to $60 million per quarter for the remainder of 2024. I will now hand it back to Scott for closing remarks before we begin Q&A.
spk13: Thank you, Mark. Looking to the rest of 2024 and 2025, we'll continue to build on the strong progress today. We look forward to upcoming clinical and regulatory milestones from Peltucetine and Atumelnet and continued advancement of our deep pipeline of emerging candidates. Chronetics continues to be well positioned to become the premier fully integrated endocrine-focused pharmaceutical company. Thank you all for your attention. Operator, we're ready to take questions. For folks on the call, we'd appreciate it if you could limit yourself to one question. We have a lot of analysts on the call. We want to ensure that we can provide each of you with a thoughtful response. Thank you, everybody.
spk09: And at this time, if you would like to ask a question, please press star 1 now on your telephone keypad. To withdraw yourself from the queue, you may press star 2. We'll take our first question from Jessica Fye of JPMorgan.
spk17: Hey, guys. Good afternoon. Thanks for taking my question. And Mark, it's been great working with you over the years. I was wondering how we should think about what additional insights we could expect to gain from the Phase 2 updates in CAH and Cushings coming later this year and what venue or venues we should look for those at.
spk13: Thank you, Jess. Let me hand that over to Alan to give you a brief.
spk05: Yeah, you know, we will have final or top-line results in CAH and Cushings disease, hopefully, and we will be able to sort of continue to support the messages, I believe, that we have already communicated with the Endocrine Society. I mean, this appears to be a uniquely effective agent in these disease states in terms of biomarker responses. I think, you know, with higher sample sizes, we'll have a greater variety, a greater number of patients evaluated and we'll have, most importantly, probably from the regulatory standpoint, is the dose-response relationship fully described. And I think that's what will trigger, that's the information we need to really fully design our Phase 3 program and go forward in development.
spk13: Yeah, and maybe as a quick reminder to those not as close to it as us, that we now have the 40, 80, and 120-milligram cohorts enrolled, and the data from
spk04: those groups will be available later this year.
spk20: Thank
spk04: you. We'll take our next question from Yasmeen
spk09: Rahimi of Piper Sandler.
spk18: Mark, we're going to greatly miss you. It's been really a pleasure working with you and you've done a tremendous job. So we will definitely miss you and hope the search continues for a little longer so we can continue working with you. I wanted to ask just a question on carcinoid. If you could provide some color around engagement with the agency, where are you in terms of the sign-off and what's sort of left to do to kick off the registrational study? And I'll jump back into the queue.
spk11: Thanks, Yas. Danny, you want to handle that one? Well, yeah, we've just completed all the analyses that we needed to do and are, you know, essentially ready to, you know, start the process of engaging with them. So it shouldn't take too long to get that squared away. As we mentioned, we're expecting to get the trial up and running by the end of the year. So, you know, we have not, you know, yet completed the discussions with them. So,
spk04: you know, we're sort of actively involved. We'll take our next question from Jeff Hung of Morgan Stanley.
spk07: Thanks for taking my question and best wishes to Mark. You mentioned that you may advance your ADPKD program with a partner independently. What would be the deciding factors for Connexion to go with one strategy versus the other? And is that only relevant to this program or are there specific early stage programs that you would not be open to partnering?
spk04: Well,
spk13: so there's a couple of considerations. Thanks for the question, Jeff. A couple of considerations. One is, you know, we've built a remarkably strong team in the endocrinology area and we would need to start building out our kidney capabilities, our nephrology capabilities in order to do justice for this program. That being said, I think that's quite a reasonable thing for us to do. As a reminder, the polycystic kidney program and the PTH antagonist program both address nephrology populations. So, there would be some synergy there. On the other hand, there may be groups out there that are further advanced than us in the field and could do better justice to this program more rapidly. And I'll also just say that, you know, given the productivity of our discovery group and the depth of our pipeline, I want to make sure that from an internal perspective, we can grow adequately to give each program its due resources and attention. And so that growth of the company is a factor as well. We're in a very fortunate position to be able to have to make choices like
spk04: this. Great. Thank you. We'll take our next question from Dennis Dean of
spk09: Jeffreys.
spk03: Hi, thanks for taking our questions. Maybe if I can ask one on acromegaly. Here's how you're thinking about the pricing strategy once you guys eventually get approved next year and if you plan a price at a premium given your norm. Thank you so much.
spk04: Thanks, Dennis. I'll let Jim handle that one. Thanks, Dennis.
spk01: You know, still too early to talk about pricing. We are engaged with, as we mentioned, we are engaged with payers and sharing the value proposition. And again, it has been some encouraging conversations to date. But again, we just need to have a deeper look at a number of factors before we disclose pricing
spk04: probably next year. Thank you. Our next question is from Joseph Schwartz of Lerink Partners.
spk06: Great. Thanks very much. And best wishes to Mark, of course. It's been great to work with you. Are specific clinical outcomes being systematically measured in Toucan or was the observation of two patients who resumed menstruation something that was just noticed? I'm just wondering if there are other clinical benefits that might arise when you report top line data in the second half. Alan, would you like to answer Joe?
spk05: Yeah, so in addition to our standard endocrine biomarkers to assess disease state in CH, there's a large number of clinical parameters that are observed as part of any clinical trial. But in particular, this one, we do follow certain things very carefully, particularly menstrual function. We have menstrual diaries in these trials. For example, we also look at metabolic control and other ways using various kinds of blood testing. We know that, for example, glucose is an important parameter in these patients and other like measures. There's actually going to be a large number of what I would call patient reported outcomes and also position reported outcomes. Both in phase two, but even more importantly in phase three, when we have larger numbers of patients to assess of both genders.
spk04: Very helpful. Thanks, Alan. We'll take our next
spk09: question from Gavin Clark Gartner of Evercore ISI. Your line is open.
spk15: Hey, guys. Thanks for taking the question. I just wanted to ask more specifically on the carcinoid regulatory feedback as we're getting close to that. What's your desired base case or expectation on primary endpoint confidence that a placebo comparator arm will be viable and also just reconfirm you're looking at both switch and new starts and confirming those would be within the same one trial. Thank you.
spk11: Okay, thanks. As far as the, you know, the patient population, we're definitely intending to include both, you know, previously treated and nine patients. I think that, you know, the we have looked at, you know, a lot of different ways to estimate efficacy. And since there's no real sort of, you know, guidances from FDA in this indication, it's a little bit, you know, sort of ours to propose. Right. So I think that, you know, we'd rather kind of have the discussions first and then disclose where we're going. You know, after we've designed the trial.
spk04: Thanks. Evan, that you asked.
spk15: It's just reconfirm whether placebo or an active comparator arm may be required.
spk04: Our plan is that a placebo trial will be required. Yep. Thanks. Our next question is from
spk09: Ryan, of Baird.
spk16: Hi, this is Charlie on for Brian. Thanks for taking our question. So just thinking about the profile of Peltucitin we've seen so far. Do you have any plans to investigate in the treatment of neuroendocrine tumors in
spk04: the future? So, we
spk13: are using it to treat neuroendocrine tumors in those patients that experience the symptoms of carcinoid syndrome. So perhaps you're referring to understanding the anti tumor activity that's well described as part of a somatostatin receptor ligands on these tumor types. And so we are thinking that as part of our phase three, we will be
spk03: observing
spk13: tumors both in the phase three study in itself and in open label extensions. But we're not designing the trial to measure anti tumor activities as we think we've got a wide range of other areas we should be investing in. And that the treatment of patients with neuroendocrine tumors is moving more and more to somatostatin analogs for symptom control and other modalities are coming in play for treatment of the tumor growth itself. And I think you'll hear more from us in the coming quarters
spk04: about some of these details.
spk09: Thank you.
spk04: We'll take our next question from Catherine
spk09: Novak of Jones research.
spk19: Hey, good afternoon guys. If I can just one about the pipeline again, I'm about curious about the role of three agonism and ADPKD. You can just talk about your decision to go into ADPKD and how this approach might differentiate from earlier studies that looked at anti prolific drugs, which seem to reduce kidney volume, but not necessarily improve kidney function per se.
spk13: Yeah, no, thanks Catherine. And that's that question could justify a half a day conversation about the science here, but it is fairly remarkable that as we were looking through the literature, just in our day to day scientific reading, we noticed that the people studying silly apathy's of which poly cystic kidney is a one of the manifestations of the silly apathy's. That everybody was using an antibody against three as a cytologic marker for immunostaining of the of the silly. So, three is expressed very cleanly in silly. And we know that the silly, silly apathy's are caused by mutations and poly systems, which results in an imbalance of the cyclic AMP and calcium ratio in the silly. And also matter that with with too much cyclic AMP and also matter that analogs are acting also metastatic receptors are acting to decrease cyclic AMP levels in cells. And in this case, in the primary silly. So we'll be coming out with more and more data around this, but we've developed animal models in genetically engineered mice. We've done this models and dispersed kidney cells. We've done signaling. We've done a variety of things to begin to shore up the hypothesis that activating the three will be effective in poly cystic kidney disease. But of course, the real test is to get it into patients and see what it does. So that's what we're trying to figure out how to get there, whether either ourselves or through partners, but a huge unmet need. And just as a hint, we don't expect based on the location in the renal tubules that this will cause the type of very high urine volumes that you see with the with the phase of precedent antagonists like 12 apt and. And that's one of the major limiting tolerability issues around the use of top.
spk20: Right. Well, thanks. I'm definitely looking forward to hearing more from that program in the future.
spk04: Super exciting, very high on my need.
spk09: We'll take our next question
spk04: from
spk09: John Wallaby of citizens. JMP.
spk08: Hey, good afternoon. Thanks for taking the question and best wishes to mark. I was hoping you guys could talk a little bit about how you're thinking about next steps to simply in if you think you'd have enough information to move forward to a people trial and then how you think about integrating younger patients
spk04: into the program as well.
spk11: Well, thanks so much for the question. Yeah, those are definitely key areas for us in the future. As Alan mentioned, and Scott mentioned before that, we're really encouraged by the data so far for and we think that once we have the full complement of patient data, we'll definitely be able to talk to the FDA about the design of phase three. So I think the data that we generate from those three cohorts in that trial will certainly be enough to go talk to the agency about our phase three design. And as far as the pediatric program, you know, we're also actively, you know, putting together protocol designs to evaluate that in phase two, and then be able to use that, you know, to very quickly move into phase three, because that obviously is a significant unmet medical need with the. Profound morbidity for those kids. So we're very,
spk04: very focused on that. That's helpful. Thank you very much. Take our next question from Leland Grishel of Oppenheimer.
spk13: Hey, good afternoon. Thanks for taking my questions and Mark has been great working with you and best of luck in the future. Scott want to ask on your thyrotropin receptor program. You'd mentioned recent calls that you've been moving
spk08: nicely
spk13: along with potential candidates. Just wondering where you may be there. Could we see a clinical candidate nominated in the next few months or perhaps in 2025? Thanks. Yeah, thanks Leon. It's always hard to say when you're going to get there. The process of drug discovery is very much an asymptote and you just keep getting closer and closer and closer to what you think is an ideal candidate. And a certain point you say that's good. That's good enough. And I got to say that in in the TSH antagonist where one to two percent of the population can have this disease. And we just saw, I just saw the news this morning that one of my favorite characters, Ray in Star Wars was just diagnosed with Graves disease. But this molecule needs to be really high quality. So we are working hard on that. I can I can tell we're really close. But whether that's this quarter, next quarter, early next year, I don't know for sure,
spk04: but
spk13: it's
spk04: it's right around the corner. Great. Thank you. We'll take our next question from Douglas
spk09: Sowell of HC Wainwright.
spk02: Hi, good afternoon. Thanks for taking the questions and I'll join the chorus of people saying how much we've enjoyed working with Mark over the years. I guess, you know, maybe a question for Jim, since he mentioned, you know, the fact that patients often have a very different experience with acromegaly than clinicians realize. So I guess in terms of driving adoption, you know, how do you plan to get around that? Because I think that has been a factor that has hampered the launch of my caps. You know, in terms of converting that product. And I know that the you're about to see profiles very different, much, much stronger data. But, you know, just how do you from a from a tactical standpoint plan to address that aspect of the launch? Thank you.
spk01: Thanks, Doug. And I think, you know, I'll start where you left off, which is, yeah, we've got a great product in Peltucitin. And that's something that does differentiate us certainly from most recent launches. But, however, it is true that even with such a great product, what we hear from physicians is if it's not broken, I'm not going to fix it. And that's exactly the purpose and the rationale behind our disease state campaign acromegaly truth dot com. So already, you know, there's a small contingent of endocrinologists that are behind a lot of the data in this area of, again, trying to address this this discord in dialogue. And it is really making sure that physicians are aware of the patient experience and then ensuring that, you know, as we get closer to launch, that we really do empower patients to have that discussion with their endocrinologist. Based on the research that we've done, Doug, it's a powerful message. And I know that the physicians have reacted well to the awareness. And I will tell you that patients even react better to it when they see the campaign and realize that, yes, this is the kind of discussion. These are the kinds of symptoms that they're feeling. This is what they want. This is the kind of discussion they want to have with their endocrinologist. So more to come, and we'll be providing details as to how impactful this is and what the metrics are from the campaign. But it is really that the underpinning of a great product is the awareness around the problem.
spk04: Okay, great. Thank you so much. And that's helpful. Thanks, Doug. And we'll take a question from Corey of LifeSci
spk09: Capital.
spk14: Hey, thanks for taking our questions and congrats on all the progress. And Mark, congrats on everything you've helped build over the years. We'll definitely be sad to see you go, but of course, wish you well and whatever comes next. But I guess, can you help give us a bit of context in how your launch efforts in acromegaly could potentially help support a launch in carcinoid syndrome down the line? Thinking about these prescriber groups as almost like a Venn diagram. How often might a carcinoid patient be coming in contact with an endocrinologist that might have had previous experience with palatocetin treating acromegalics? And while it's certainly been several errors ago, are there any learnings you're taking from the expansion of Oxyriotide or Lanreotide into these patient groups from acromegaly to carcinoid syndrome? Or gap nets that can be applied to your strategy with palatocetin?
spk01: Thanks, Corey. We have already started to look at the overlap in terms of the customer base. And I'll tell you where we see a great deal of overlap is in the pituitary treatment centers. So the same academic centers, there are about 45 of these pituitary treatment centers. And there is a good deal of overlap with, for example, the NCCN Cancer Network, the National Comprehensive Cancer Network. So places like Memorial Sloan Kettering, Dr. Eliza Gere is at MSK. That's also obviously a cancer institution. And as well, to your point, there are specific endocrinologists that are very much involved in neuroendocrine tumors as well. So there is also an overlap. It will be a new indication for us to get into. And oncologists are going to be a new audience for us. But again, where they're located is a lot of co-location and a great opportunity for us.
spk13: And maybe I'll just add to that, Corey, that beyond the actual practicing physicians and their staffs, launching your first drug is an exercise in building out a range of different capabilities, relationships with those institutions, the pharmacies at those institutions, relationships with the payers, and as I mentioned, just our internal capabilities. So there's a huge amount of synergy between this and then the second launch. And then that, of course, also support the third launch and fourth launches with Atumelnet and then the many, many other launches we anticipate with other
spk04: things coming out of the pipeline. Excellent. Any other questions? Thank you. And
spk09: there are no further questions at this time. I'd be happy to return the call to our hosts for any closing comments.
spk13: Thank you all for being here and listening to us. And those of you who have such affection for Mark, he's not going anywhere right away and you know how to find him. And I'm sure he'd be happy to have a drink or lunch or ice cream and ketchup sometime. Thank you all for listening.
spk09: This does conclude today's Clinetics Pharmaceuticals second quarter 2024 earnings conference call. Thank you for participating. You may now disconnect your line and have a great day.
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