speaker
Operator
Conference Operator

Welcome to Chronetics Pharmaceuticals' fourth quarter and full year 2025 financial results conference call. At this time, all participants are in listen-only mode. Following management's prepared remarks, we will hold a question and answer session. In order to ask a question, please press star then one on your telephone. I'd now like to turn the call over to Gayathri Tawaka, Head of Investor Relations. Please go ahead.

speaker
Gayathri Tawaka
Head of Investor Relations

Thank you, Operator. Good afternoon, everyone, and thank you for joining us to discuss the fourth quarter and four-year 2025 results. Today on the call, we have Dr. Scott Struthers, Founder and Chief Executive Officer, Dr. Alan Krasner, Chief Endocrinologist, and Toby Schoke, Chief Financial Officer. Also joining for the Q&A portion will be Isabel Califonos, Chief Commercial Officer. 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. 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 launch progress to date, our commercialization plan, 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's accurate only as of this live broadcast. Krenetics 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.

speaker
Dr. Scott Struthers
Founder and Chief Executive Officer

Thank you, Gayathri, and thank you all for joining us today. 2025 was a breakout year for Krenetics. We're transitioning from building a pipeline to building a business. In 2025, we successfully launched our first commercial product with a label that reflects its ability to become the preferred medical treatment for acromegaly. Palsonify uptake continues to grow. We presented compelling phase two data on our second late stage candidate that illustrates its potential to be the preferred medical treatment for congenital adrenal hyperplasia, or CAH, and Cushing's disease. Atzimelnet phase three studies in both adult and pediatric participants with CAH are underway. And today we will tell you about its phase two, three study in Cushing's disease. Finally, the first candidate from our new non-peptide drug conjugate program CRM9682 has begun the dose escalation phase of a phase one, two study in a broad basket of people with SST2 expressing tumors. With this growing pipeline and the support of our strong balance sheet, we are now focusing on building a successful commercial business that will grow into the leading endocrinology company. Turning to slide five, before I turn the call over to Alan to talk about the Ataman development program in Cushing's disease, let me take a few minutes to review results from the Palsonify launch. As we previously shared, in Q4, we received more than 200 enrollment forms. As a reminder, this included all 22 U.S. participants in the open-label extension studies of the clinical program. We're effectively getting the word out about Palsonify. More than 125 unique prescribers in both community and pituitary treatment center practices have entrusted the treatment of their patients to Palsonify. Finally, we're making significant progress with PEARS. As we announced in January, we are seeing early and encouraging formulary momentum. Payers recognize the transformative value we're bringing to the acromegaly community. We are already securing wins with some of the top plans in the country, adding Palsonify to their formulary with straightforward prior authorization written directly to our label and no step-ups. In the interim, we expect to continue seeing reimbursement through the medical exceptions process for patients from all payer types, including all government payers. Turning to slide six, with the launch of Palsonify in the US, we have built a fully integrated and highly capable commercial enterprise. Our sales professionals are in physician practices educating about Palsonify and the services Krenetics provides to patients and offices, including help from our nurse educators and field reimbursement specialists. Our efficacy first messaging shown on our HCP site on the left side of this slide is resonating with healthcare providers and they understand the importance of symptom control as well as biochemical control. Our medical affairs team is there to help with deeper scientific and medical support for providers. We're presenting data on Palsonify and the rest of our pipeline at regional and international endocrinology conferences every month. Creneticare is online and staffed by nurses to help patients navigate their acromegaly healthcare. Our first patient ambassadors, two of whom are shown on the right side of this slide, have been deployed to provide patient-to-patient conversations and testimonials. Our market access team is ensuring that all patients can get access to Palsonify. I'm very proud of the great team we've built and their passionate dedication to serving our patients. Every day, they're working hard, spreading the word, and helping people with acromegaly get access to Palsonify. Our goal for Palsonify is to become the new standard of care for people with acromegaly, and we are well on our way. But this is about more than just the launch of Palsonify. This is about building, testing, refining, and honing an enterprise to launch many new innovative pharmaceuticals to come from our pipeline. This is the core of the team that will launch Paltucetin for the treatment of carcinoid syndrome, Atomelnet for CAH, and Cushing's, and our other pipeline candidates pending their own approvals. As I said, We're now in the stage of building a sustainable business to create, develop, and deliver novel therapeutics using the tools of endocrinology. With that, I'll hand it over to our chief endocrinologist, Alan Krasner, to talk about the pipeline and the upcoming Cushing study in particular. Alan?

Disclaimer

This conference call transcript was computer generated and almost certianly contains errors. This transcript is provided for information purposes only.EarningsCall, LLC makes no representation about the accuracy of the aforementioned transcript, and you are cautioned not to place undue reliance on the information provided by the transcript.

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Investor presentation