Crinetics Pharmaceuticals, Inc.

standby. We're about to begin. Good afternoon, everyone. Welcome to the Krenetics Pharmaceuticals fourth quarter and full year 2024 financial results conference call. At this time, all participants are in a listen-only mode. Following management's prepared remarks, we will hold a question and answer session. You may register to ask a question at any time by pressing star 1 on your telephone. Also, today's call is being recorded, and with that, I'll turn things over to Gayathri Diwakar, Head of Investor Relations. Please go ahead, ma'am.

Thank you, Operator. Good afternoon, everyone, and thank you for joining us to discuss the fourth quarter and full year 2024 results. Today on the call, we have Dr. Scott Struthers, Founder and Chief Executive Officer, Isabel Calafonos, Chief Commercial Officer, Dr. Dana Pizzuti, Chief Medical and Development Officer, Dr. Steve Betts, Founder and Chief Scientific Officer, and Mark Wilson, Chief Financial Officer. Also joining us for Q&A is Dr. Alan Krasner, Chief Endocrinologist. Please note there is 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 filing. Such forward-looking statements are not a guarantee of performance, and the company's actual results can 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 Krenetic's 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 to the date of this live broadcast, February 27, 2025. Krenetics takes no obligation to revise or update any forward-looking statement 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. 2024 was a remarkable year for Krenetics. As you can see on slide three, we successfully executed on all of the key objectives we set out to accomplish. This sets the stage for what we believe will be a transformative 2025. On today's call, we'll review some of these accomplishments and outline our plans for 2025 and beyond. Since our last earnings call, the FDA accepted the NDA for our investigational drug paltucetine for the treatment and long-term maintenance therapy of acromegaly. The PDUFA date is September 25 of this year. This is our first NDA filing, and I'm extremely proud of the team for its hard work in getting us to this point. We're continuing to prepare our organization for the anticipated launch of paltucetine later this year. As part of this, we are completing the build-out of our commercial and medical affairs teams, as well as the underlying administrative infrastructure. A very important part of this was hiring Isabel Calafonos this past December as Chief Commercial Officer. She successfully launched many rare disease products at both large and small biopharmaceutical companies. Isabel has all the skill sets and relevant experience to lead us through our upcoming transition into a commercial stage company. I'm happy to introduce her to you here today. Given the strength of the clinical data for our lead programs and the deep pipeline behind them, we continue forward with our stepwise regional growth strategy in Europe. We anticipate filing the DMAA for Acromegaly shortly. We have incorporated a hub in Zug, Switzerland, and brought a general manager and leadership for EU regulatory, market access, and medical affairs. And we're beginning to extend this organization to Germany. As a leader in endocrine innovation, we plan on leveraging this infrastructure in the coming years as we evolve into a fully integrated global pharmaceutical company. Last year, we made significant progress on multiple clinical readouts, including for paltucetine's second indication, carcinoidin. In a Phase II study, paltucetine treatment demonstrated rapid, sustained reductions in frequency and severity of flushing episodes and bowel movements. We have begun activating clinical trial sites for the Phase 3 trial and expect the first patient to enroll next quarter. We also shared extremely positive data for our second candidate, etumelnat, in both congenital adrenal hyperplasia, or CAH, and in Cushing's disease. In a Phase 2 study in adults with CAH, etumelnat achieved rapid, substantial, and sustained reductions of both biomarkers, A4 and 17-OHPs. Importantly, significant clinical improvements in symptoms were also observed, which was impressive in a 12-week study. We believe that Atomelnet can provide healthier hormone levels on both dimensions, adrenal androgens and exogenous glucocorticoids, and this profile has the potential to differentiate Atomelnet and provide meaningful improvements to people living with CAH. With this in mind, we're progressing towards initiation of late-stage CAH studies in both adults and in children. These studies are designed to take advantage of etomelanin's very potent mechanism of action to provide benefits for a broad spectrum of patients with CAH. Etomelanin also demonstrated initial positive results in Cushing's disease. All participants in this phase 1B28 trial rapidly achieved normalization of urinary-free cortisol, and that is the primary endpoint required for registrational studies in Cushing's disease. We're making notable progress on our earlier stage programs, including 9682, our first drug candidate from a novel non-peptide drug conjugate, or NDC, platform. This year, we expect to submit four INDs in total, including 9682. Steve will discuss these in more detail towards the end of the call. With that, I'm pleased to introduce Isabel, who will tell you more about the progress in building our commercial capabilities.