Crinetics Pharmaceuticals, Inc.

Welcome to the Cryonetics Pharmaceuticals fourth quarter and full year 2023 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. I will now turn the call over to Corey Davis of LifeSite Advisors. Please go ahead.

Thank you, Sergio, and hello, everyone. Joining me on the call today are Scott Struthers, founder and chief executive officer, Alan Krasner, chief endocrinologist, and Mark Wilson, Chief Financial Officer. Also joining us for the Q&A portion of the call are Dana Pizzuti, Chief Medical and Development Officer, and Jim Hazard, Chief Commercial Officer. A press release announcing the fourth quarter and full year 2023 financial results was issued today and is also available on the Chronetics 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 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. 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 Crenetics SEC filings, including its annual report on Form 10-K. I'd also like to specify that the content of this conference call contains time-sensitive information that is accurate only as the date of this live broadcast, February 28, 2024. Corinnex takes no obligation to revise or update any forward-looking statements to reflect events or circumstances after the date of this call. I'll now hand the call over to Scott Struthers. Scott, go ahead.

Thanks, Corey. Good afternoon, everyone, and thank you for joining us for our quarterly results call. As the company progresses towards commercialization, it's our intent to expand our investor outreach and provide regular opportunities for interactive dialogue. We appreciate your attendance and look forward to our discussion today and on future quarterly calls. To begin, I'll spend a few moments summarizing our recent accomplishments before turning the call over to Alan Krasner, our chief endocrinologist, to discuss our clinical programs and recently reported data in some more detail. Before we get started with a review of 2023, I wanted to say how pleased we are to have announced a private placement equity financing of approximately $350 million earlier today. We're very appreciative of the continued support that we've received from new and existing shareholders who share our long-term vision for building the premier endocrine company to help patients suffering from a wide range of different endocrine-related diseases. This financing is simply one more step forward in that strategy. 2023 was a tremendously successful year for chronetics on many fronts. I'll begin with our lead development candidate, paltucetine. Paltucetine continues to deliver impressive results in the two indications for which it is being developed, acromegaly and carcinoid syndrome. In September, we reported clinical results in acromegaly that exceeded expectations. Our Phase III Pathfinder 1 trial achieved its primary endpoint of maintaining IGF control and met all secondary endpoints with high statistical significance. As a reminder, Pathfinder 1 was designed to evaluate oral paltucetine in patients with acromegaly who are already controlled on standard of care, which are injected somatostatin receptor ligand depots or SRL therapy. Our intention for this trial is to support an indication for the maintenance of acromegaly treatment. In other words, to maintain biochemical control in patients switching from standard of care injectables to once daily oral paltucetine. In contrast, our second phase three trial, Pathfinder 2, is evaluating paltucetine in patients with acromegaly who have elevated IGF levels above the normal range. These are patients who are either naive to therapy, untreated for at least four months, or patients who agreed to wash out of the standard of care as part of entering the study. We completed enrollment in Pathfinder 2 last year, and we are on track to unblind and report top line results in March. If successful, we intend to submit an NDA supported by these results from both studies to the U.S. FDA in the second half of 2024. Overall, our Pathfinder program is intended to provide a broad label for the treatment of acromegaly. Moving now to carcinoid syndrome, our second intended indication for paltucetine. In December, we reported initial results from our ongoing open-label Phase II trial in patients with carcinoid syndrome. From a safety point of view, peltucetine continues to be well-tolerated in this patient population, consistent with what we've seen from our other clinical studies to date. With regard to efficacy, to date we are seeing clear reductions in the two key symptoms of carcinoid syndrome, which are excess bowel movement frequencies and flushing episodes. Results from December were from a subset of patients, and the study is now fully complete with a total of 36 patients. In the profile we reported in the initial results is confirmed in the top line results that we are expected in the first half of this year. We're excited to move forward into phase three studies in carcinoid syndrome pending alignment with the FDA on the study design. Following in the footsteps of Taltucetin, we built a remarkably deep pipeline. Our second molecule, 4894, is currently being evaluated in an open-label phase 2 trial in patients with congenital adrenal hyperplasia, or CAH, and a second trial in patients with ACTH-dependent Cushing's disease. People with CAH are unable to make cortisol and instead make excess adrenal androgens, and 4894 is an oral ACTH antagonist designed to normalize levels of adrenal androgens. Alan will elaborate on this program, and we anticipate reporting initial results from a subset of patients in the second quarter of the year. Beyond 4894, we're also advancing multiple preclinical programs, including a parathyroid hormone, or PTH, receptor antagonist for the treatment of hyperparathyroidism, a TSH antagonist for the treatment of Graves' disease and thyroid eye disease, and candidates for metabolic disease, diseases, including diabetes and obesity. These are just a few of the many early-stage programs in our pipeline, and we plan to provide you with regular updates on these and other development candidates when appropriate. In anticipation of a potential 2025 launch of paltucetine, we also remain focused on building out our commercial organization. Acromegaly and carcinoid syndrome together present a multibillion-dollar market opportunity. We're actively developing commercial capabilities for these markets, identifying key prescribers, and tailoring our launch strategy. We know that Pathfinder 1 data is resonating well, creating excitement among the acromegaly and carcinoid syndrome prescribers and the patients. Understanding payer perspectives is also crucial, and Jim Hazard and our chief commercial officer is building a market access team to build relationships with these important stakeholders. We're preparing logistics, finalizing specialty pharmacy agreements, and generally preparing the company for commercial readiness on all fronts. Looking forward to the rest of 2024 and 25, we anticipate multiple transformative milestones ahead. Completing Pathfinder 2. Completing Phase 2 followed by initiation of a Phase 3 study in carcinoid syndrome. Completing a Phase 2 and initiating a Phase 3 in CAH. submitting our first NDA, and launching Peltucetine for Acromegaly, if approved. Moreover, continuing to advance our pipeline of promising candidates in high prevalence indications that are beginning to emerge from discovery. We will also continue to invest in our world-class discovery capabilities that are the roots of our long-term success. With that, let me hand it over to Dr. Alan Krasner, our chief endocrinologist, to talk about our clinical program and the results we're seeing today. Alan?