Crinetics Pharmaceuticals, Inc.

Welcome to the Chronetics Pharmaceuticals First Quarter 2025 Financial Results Conference Call. At this time, all participants are in listen-only mode. Following the management's prepared remarks, we will hold a question and answer session. Please press star followed by one on your telephone keypad. If you change your mind, please press star followed by two. I would now 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 first 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 Calafonos, Chief Commercial Officer, and Toby Schilke, Chief Financial Officer. Dr. Alan Krasner, Chief Endocrinologist, will also be joining for the Q&A portion. Please note there is a slide deck for today's presentation, which is in the events and presentation section of the investors page on the Crunetics website. In addition, a press release was issued earlier today and is also available on the corporate website. Slide two. As a reminder, we will 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 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 chronetics 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, May 8, 2025. 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, Guthrie, and good afternoon to everyone joining in today's call. We're pleased to share our first quarter results and highlight the great progress we're making towards our mission of transforming the lives of patients with serious endocrine and endocrine-adjacent diseases. Turning to slide three, kinetics has never been stronger, and I want to emphasize that. We're strategically positioned for long-term, sustainable growth. Our immediate focus is on the anticipated commercial launch of our first product this year. This is a pivotal milestone for the company. We believe Peltucetin has the potential to deliver meaningful improvements for people living with acromegaly. Faced by an experienced team deeply embedded in the endocrinology community and driven by a strong commitment to patients and science, we're well on our way to becoming a fully integrated global commercial organization. We're advancing a robust pipeline in parallel, including two late stage candidates, one recently clearing IND, and three additional candidates in preclinical studies. With $1.3 billion on the balance sheet, we're able to continue to invest in our pipeline, support prospective launches, and thoughtfully pursue opportunities and enhance value across our portfolio. We have never been stronger. I'd like to take a moment to welcome Toby Schilke. who you'll be hearing from towards the end of today's call. Toby recently joined as Chief Financial Officer, and he brings over 25 years of global experience with a proven track record of guiding companies through the transition from R&D-focused ventures into fully integrated commercial organizations. Toby's extensive financial and operational experience will be invaluable as we accelerate our growth trajectory and position Krenetics for long-term success. I also wanted to reassure you that regulatory engagement with the FDA on the Caltucetine NDA for acromegaly, as well as our other clinical development activities, have been proceeding on track. We're grateful for the ongoing professionalism and commitment of the staff at FDA with whom we interact. We remain proactive in monitoring the evolving regulatory environment and maintaining active dialogue with key stakeholders, both in the administration and on Capitol Hill. As you'll hear from Isabel, we're laser-focused on preparing for the anticipated launch of Peltucetine in September. This will be our first product approval and a defining milestone for our ambition to become a fully integrated pharmaceutical company. On today's call, we'll walk through some of the launch initiatives we are executing and reflect on the progress the team has made to date. Turning to AstraZeneca, we remain very encouraged by its potential to establish an uncompromising adrenal hyperplasia. We're moving forward to the phase three study for adults with CAH that Dana will describe in some detail. At a high level, this study is designed to redefine the standard of care as the achievement of normal adrenal androgen levels with only physiologic levels of glucocorticoid replacement. We believe atumelan should be used to treat the disease and glucocorticoid should only be used for physiologic replacement, not treatment. With that, I'll hand the call over to Isabel to update on our Acromegaly launch preparations. Isabel?