Crinetics Pharmaceuticals, Inc.

Welcome to Krenetics Pharmaceutical School's second quarter 2025 financial results conference call. At this time, all participants are on listen-only mode. Following the management's prepared remarks, we will hold a question and answer session. In order to raise a question, please signal by pressing star followed by one on your telephone keypad. To remove yourself from the line of questioning, it will be star followed by two. And I would like to turn the call over to Gayathri De Walker, Head of Investor Relations. Please go ahead.

Thank you, Operator. Good afternoon, everyone, and thank you for joining us to discuss the second quarter 2025 results. Today on the call, we have Dr. Scott Struthers, Founder and Chief Executive Officer, Dr. Dana Pizzuti, Chief Medical and Development Officer, Isabel Calazono, Chief Commercial Officer, and Toby Schoke, Chief Financial Officer. In addition, Dr. Steve Betts, Founder and Chief Scientific Officer, and Dr. Alan Krasner, Chief Endocrinologist, will also be joining for the Q&A portion. 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 Kinetics 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 risks 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 our commercialization plans, as well as estimates related to market size, growth, and other data about the African-American market. Projections, assumptions, and estimates of the future performance and the future performance of the markets in which we operate are 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 the date of this live broadcast, August 7, 2025. Prenetics 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 good afternoon to everyone joining today's call. Turning to slide three, we are pleased to provide an update on our corporate progress and share our second quarter results. We continue to execute on our mission to develop innovative therapies for patients with endocrine diseases and endocrine-related tumors. As we approach the pivotal moment of our pending approval of our first NDA, I'm pleased to report strong execution across all aspects of our business. I want to begin by reaffirming that the Paltucidine NDA review remains on track. We continue to work closely with the FDA towards an anticipated approval in September. We are grateful for the FDA's commitment to this important work and their collaborative approach throughout the process. Our regulatory team has maintained excellent momentum and remain confident in our timeline and preparations for what will be a transformational launch for CNET. We've assembled an outstanding launch team of experienced professionals, both in our headquarters and in the field, who bring deep expertise in endocrinology and rare disease commercialization. The caliber of talent we've attracted speaks to the excitement around CalSanify and its potential impact on patient care. Recently, we hosted a group of more than 40 people living with acromegaly at our headquarters in San Diego as part of our ongoing engagement with the patient community. We have worked with the acromegaly advocacy group since before peltucetine entered the clinic. We continue to seek their insights to shape our commercial strategy. At this most recent patient event, I heard directly about their experiences with their disease and their interactions with the healthcare systems around the country. After talking with them personally, I am more confident than ever that Palsonify's profile addresses a critical unmet need that will make a very positive impact on all these patients' daily lives. Deeper in the pipeline, We continue to make progress towards initiating four additional pivotal programs. Trials of peltucetine for the treatment of carcinoid syndrome and etumelanet for the treatment of adult and pediatric congenital adrenal hyperplasia are ramping up now. We remain highly encouraged by the potential of etumelanet's novel mechanism of action in ACTH-dependent Cushing's syndrome, and following extensive conversations with multiple regulatory authorities, anticipate initiation of a phase 2-3 study in the first half of 2026. The enthusiasm for our earlier pipeline continues to build. The phase 1-2 study of CRN9682 and SST2 expressing solid tumors is ramping up, and our work towards IND submissions across multiple additional discovery stage programs continues. As you may have seen, we've been extremely active at several key endocrinology conferences over the last few months, including Endo 2025 last month in San Francisco. We delivered six poster presentations and two oral presentations covering Palsonify and Acromegaly, Etumelnet and CAH, and our Thyroid Stimulating Hormone, or TSH, receptor antagonist program. We also hosted product theaters and innovation sessions to highlight our pipeline's differentiation and met with key opinion leaders across the different indications we were pursuing. Among the presentations at ENDO was an update of CRN12755, our TSH receptor antagonist candidate for the treatment of Graves' disease. We believe this novel mechanism of action has the potential to be a single oral therapy that addresses the core driver of Graves' disease in order to treat both Graves' hyperthyroidism and treat or prevent thyroid eye disease. Turning back to the launch of Palsonify, I'm energized by the team we've built The progress we've made with Acromegaly. With that, let me turn the call over to Isabel to tell you more.