Crinetics Pharmaceuticals, Inc.

And I'd like to turn the call over to Gayathri Diwakar, Head of Investor Relations. Please go ahead.

Thank you, Operator. Good afternoon, everyone, and thank you for joining us to discuss the third quarter 2025 results. Today on the call, we have Dr. Scott Struthers, Founder and Chief Executive Officer, Isabel Calafonos, Chief Commercial Officer, and Toby Schilke, Chief Financial Officer. Also joining for the Q&A portion will be Dr. Steve Betts, Founder and Chief Scientific Officer, Dr. Dana Pizzuti, Chief Medical and Development Officer, and Dr. Alan Krasner, Chief Endocrinologist. Please note there's a slide deck for today's presentation, which is in the Events and Presentations section of the Investors page on the Clinetics website. In addition, a press release was issued earlier today and is also available on the corporate website. Slide two. As a reminder, we'll be making forward-looking statements, and I invite you to learn more about the risk and uncertainties associated with these statements as disclosed in our SEC filings. Such forward-looking statements are not a guarantee of 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. In particular, today we will be reviewing launch progress to date, our commercialization plans, as well as estimates relating to market size, future performance, and other data about the acromegaly market, which are all necessarily subject to a high degree of uncertainty and risk. 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 Kinetics SEC filings, including its annual report on Form 10-K and quarterly reports on Form 10-Q. I would also like to specify that the content of this conference call contains time-sensitive information that is accurate only as of this live broadcast. Kinetics takes no obligation to revise or update any forward-looking statements to reflect events or circumstances after the date of this conference call. With that, I'll hand the call over to Scott.

Thank you, Gayathri, and thank you to everyone joining us on today's call. This is a landmark year for kinetics. It's a rare privilege to be part of a team that has taken a molecule conceived in our own lab developed with our own global clinical trial and is now bringing it to patients as a commercial stage biotech. With Palsonify, we are now redefining efficacy in acromegaly as both biochemical and symptom control. And when you think about it, when's the last time you know of someone who made an appointment with their HCP to complain about their lab results? On slide five are pictures of people we've gotten to know, people who have acromegaly, carcinoid syndrome, CAH, and have helped guide the vision for Palsonify and Etumelnet. We've worked with the Acromegaly community for over a decade. We've listened to their stories and hopes, stories from Ellen about the frustration of symptoms that injections don't fully control, or from Wendy about the simple desire to feel like yourself again. We recently observed Acromegaly Awareness Day and utilized this important moment in time to both drive broader consumer awareness of the disease and advance our patient engagement strategy. Our own chief endocrinologist, Dr. Alan Krasner, and Acromegaly patient, Tony, were featured in numerous broadcast media interviews across key Palsanify markets. These broadcasts will continue throughout the month of November, pointing viewers and listeners to acromegalyreality.com. I am proud we can help them and many, many others struggling with Acromegaly enter a new era of therapy with Palsanify. My hope is that Palsanify brings them freedom, freedom from the symptoms and freedom from the burdens of managing their disease. I hope they can focus on their lives while Palsanify fades into the background as just another pill that they take in the morning. Palsanify is just the beginning. We've proven that we can discover important new drugs, proven that we can conduct high-quality global clinical development, and are now in the early stages of proving that we can bring them to people struggling with acromegaly as a commercial company. We plan to apply that same focus intensity to carcinoid syndrome and CAH and the other serious endocrine diseases in our pipeline. We're just getting started. With slide six, I'm excited to share that the launch of Pelsonify is going very well. Isabel will share more details. Our goal is to make Pelsonify the first-line treatment of choice for Acmegaly. In the initial 31 weekdays since approval, we've already made significant progress, and the team is executing seamlessly. The first patients received their bottles of Pelsonify only 11 days after the PDUFA date. All U.S. patients in our open label extension studies are in the process of transitioning to commercial supplies. As expected, the bulk of our initial patients are those switching to Pelsonify from other therapies. However, we're also pleased to see a number of patients who are newly diagnosed starting with Pelsonify as their first medical therapy. We are making headway activating the pituitary centers and have had very good reception in from community endocrinologists, some of whom are proactively calling their patients to have them come in to talk about Pelosonify. I've spent a lot of time in the past few weeks with our field force and their enthusiasm and knowledge of the practitioners and offices in their territories is impressive. But we aren't relying on just the sales force, it's our entire field team, MSLs, field reimbursement specialists, nurse educators, our clinical development team, and executives. We're all out there trying to help improve the care of people with acromegaly. I'm also pleased that our early experience indicates that payers also recognize the value of Palsonify. Prior authorizations have been mostly straightforward, and in some cases, reimbursement has been approved for up to 12-month supplies, even before we've secured formulary coverage. Because of our proactive work with payers, we're seeing meaningful numbers of patients starting on reimbursed Pelsonify. I look forward to January when we'll have a full quarter's worth of launch metrics to share with you. At that time, we will update on revenue, new patient starts, number of unique prescribers, and further characterize what we're seeing on the payer reimbursement side of the business. We are currently in the earliest days of phase one of our three-phase strategy illustrated on slides acromegaly get the care they need. The focus of phase one is to concentrate on switching patients already on injectable SRL depots and other therapies to Palsonify. This is a readily identifiable population regularly visiting their HCP offices. In this phase, we also think that Palsonify's rapid onset of action will make it the medical therapy of choice to treat newly diagnosed patients. Looking ahead to next year, while we continue to serve both switching and naive patients, we will also begin additional efforts towards returning previously diagnosed patients back to care. There are multiple reasons why these 1,700 patients have discontinued medical therapy recently. We hope that Palsanify will provide a path for them to return to the care they need. From there, we will extend our efforts to reach the approximately 7,500 follow-up after diagnosis and returning them to medical care. There can be multiple reasons why these patients have discontinued medical therapy. It won't be easy and it will take time, but we believe that Palsonify will offer these patients a path back to care as well. The third and final phase will be to improve the time to diagnosis of acromegaly. Diagnosing acromegaly is easy once you suspect it, but suspecting it can be challenging even for experienced providers. We anticipate launching specific initiatives later next year, and our general efforts to improve acromegaly awareness and its treatment options should start making a difference sooner. But the story of Krenetics is not just the acromegaly launch. It's about our execution across the entire pipeline shown on slide 8. I want to emphasize the strength and depth of what we've built through our internal discovery and development efforts. On the discovery front, we remain committed to holding our clinical candidates to the highest possible standards. Unfortunately, during IND-enabling tox studies, we identified weaknesses in our lead TSH candidate for Graves' disease. Therefore, we're delaying the IND timelines as we prioritize and activate the best of the backup molecules. We're also delaying the timelines for our SST3 agonist program for ADPKD as we conduct follow-ups to the core IND-enabling studies. Given the launch of Palsonify and Acromegaly and the multiple late-stage programs in development, we will no longer provide regular updates on the timing of preclinical programs until those programs dose their first patient in a Phase I study. But rest assured, we are committed to not only advancing the late-stage pipeline, but also to expanding the clinical pipeline and our discovery activities continue unabated. Expect the clinical pipeline to continue to expand in 2026 and the years to come. Moving to the top of the pipeline, carcinoid syndrome is the second indication in development for paltucetine. People with carcinoid syndrome struggle with debilitating and frequent flushing and bowel movement episodes. Like in acromegaly, standard of care for these patients is painful monthly depot injectable SRLs. Based on our phase two data, we believe paltucetine could offer consistent daily control of these in an oral formulation. Our Phase III study, shown here on slide 9, is designed to evaluate its efficacy and safety in both naive and switch patients, and the OLE study will also evaluate control of the underlying neuroendocrine tumors. More than 20 clinical sites have been activated and are currently screening patients for this study. Complementing Paltucetin is CRN9682, the first candidate from the non-peptide drug conjugate program. 9682 is comprised of a novel ligand targeting SST2 to drive internalization into tumor cells, a novel linker that is cleaved only in the tumor cell, and a payload to be delivered, in this case, MMAE. We believe 9682 will be differentiated from other current modalities, and as shown on slide 10, we are studying it in the BRAVEST Phase 1-2 basket study in patients with SST2-expressing tumors. This includes neuroendocrine tumors, as well as other types of tumors that overexpress SST2. The first six sites in this study have been activated and are actively screening patients. The enthusiasm for this study from both investigators and potential participants has been high. This is an important study for kinetics. It's designed to provide the first human proof of concept for our entire NDC platform, and we're thrilled for it to be underway. Moving on to Atamelnet on slide 11. In the first three cohorts of our Phase II Toucan trial for congenital adrenal hyperplasia, or CAH, etzumelanin showed a remarkable ability to highly suppress adrenal androgens in these patients. As you know, we added a fourth cohort to look at morning dosing instead of evening dosing, as well as the ability to lower adrenal androgens while simultaneously reducing glucocorticoid therapy towards physiologic levels. Patients in this fourth cohort have recently completed their 12-week treatment period, and we continue to see favorable benefit-risk profiles. I look forward to sharing the data from cohort four in January once our analysis is completed, along with initial data from a handful of patients from prior cohorts who have now reached the 13-week assessment in the open-label extension study. Now moving on to the design of our global phase three CALM-CAH trial of Atumelna in adults with CAH, The study shown on slide 12 builds on the strong top line results from the first three cohorts of our phase two study. It's designed to provide a novel therapeutic paradigm for CAH where atom melanin is used to treat the disease itself and glucocorticoids are only needed for physiologic replacement. People with CAH deserve physiologic levels of both and that is why we're utilizing a novel uncompromising primary endpoint that combines both goals. This is a very high bar, but appropriate for the level of efficacy we expect from anti-balance. I'm pleased to report that the first sites for the column CAH trial have been activated. Screening is underway, and we expect the first patients to be randomized before the end of the year. Moving on to slide 13, which shows our balanced CAH study for pediatric patients in more detail, we believe it is crucial to address both high androgen and glucocorticoid levels in pediatric patients because each can cause significant clinical sequelae, and we designed our clinical program with that goal in mind. This study is an operationally seamless Phase 2-3 design with a Phase 2 dose selection during which glucocorticoids remain stable, followed by a Phase 3 portion in which new patients will be randomized and have the opportunity to taper glucocorticoids. Eligible patients from both phases will have the opportunity to enroll in an open-label extension, We look forward to enrolling the first patient before the end of the year. With that, let me turn the call over to Isabel to provide additional color on the launch of Palsonify for acromegaly. Isabel?