On May 3, 2023 Corcept Therapeutics Incorporated (NASDAQ: CORT), a commercial-stage company engaged in the discovery and development of medications to treat severe endocrine, oncologic, metabolic and neurological disorders by modulating the effects of the hormone cortisol, reported its results for the quarter ended March 31, 2023 (Press release, Corcept Therapeutics, MAY 3, 2023, https://ir.corcept.com/news-releases/news-release-details/corcept-therapeutics-announces-first-quarter-financial-results-0 [SID1234630908]).

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Financial Results

Revenue of $105.7 million, compared to $93.7 million in first quarter 2022
Raised 2023 revenue guidance to $435 – $455 million, from $430 – $450 million
Net income per common share of $0.14 (diluted), compared to $0.20 in first quarter 2022
Cash and investments of $465.1 million as of March 31, 2023
Purchase of 6.6 million shares of Corcept common stock for $145.4 million in April 2023
Corcept’s first quarter 2023 revenue was $105.7 million, compared to $93.7 million in the first quarter of 2022. First quarter operating expenses were $90.8 million, compared to $66.9 million in the first quarter of 2022, due to increased spending on clinical trials and sales and marketing activities and to support the expansion of our clinical development and commercial teams. Net income was $15.9 million in the first quarter of 2023 compared to $22.8 million in the same period last year.

Cash and investments were $465.1 million at March 31, 2023 compared to $436.6 million at December 31, 2022. In April 2023, Corcept purchased 6.6 million shares of its common stock for $145.4 million.

"Korlym is an excellent treatment for patients with Cushing’s syndrome and there are many eligible patients who have yet to receive it. We are making substantial investments to improve the ability of physicians to identify and treat patients with hypercortisolism, most notably our recently established CATALYST study, and are optimistic about the growth of our Cushing’s syndrome business. We are raising our 2023 revenue guidance to $435 – $455 million," said Joseph K. Belanoff, MD, Corcept’s Chief Executive Officer.

Clinical Development

"In the next twelve months we expect data from our GRACE, GRADIENT and NASH Phase 1b studies, submission of the NDA for relacorilant in Cushing’s syndrome, completion of enrollment of our CATALYST, ROSELLA and DAZALS studies and initiation of a Phase 2b trial of miricorilant in patients with NASH," added Dr. Belanoff.

Cushing’s Syndrome

Phase 3 GRACE trial of relacorilant as a treatment for patients with all etiologies of Cushing’s syndrome – new drug application (NDA) submission expected in the first half of 2024
Enrollment continues in Phase 3 GRADIENT trial of relacorilant as a treatment for patients with Cushing’s syndrome caused by adrenal adenomas
Enrollment continues in CATALYST – 1,000-patient Phase 4 trial examining the prevalence of hypercortisolism in patients with difficult to control type 2 diabetes; patients with hypercortisolism may enter a randomized, double-blind, placebo-controlled study of Korlym
Our GRACE trial will serve as the basis for relacorilant’s NDA in Cushing’s syndrome, which we plan to submit in the first half of 2024. We are pleased to share that we have identified all the patients necessary to complete this study and expect to complete enrollment in the coming weeks. Our Phase 3 GRADIENT trial will produce valuable data about an etiology of Cushing’s syndrome that affects many patients but has not been rigorously examined in a controlled study.

"Independent studies conducted over the last fifteen years have found that the prevalence of hypercortisolism in patients with type 2 diabetes is substantially higher than in the general population. The most prominent diabetologists in the United States helped us design and are participating in our CATALYST trial, which will be the largest study of its kind and is now enrolling patients. CATALYST identifies patients whose diabetes is caused by hypercortisolism and offers them a placebo-controlled study where Korlym is the active treatment. We expect to complete enrollment by the end of this year," said Bill Guyer, PharmD, Corcept’s Chief Development Officer.

Oncology

Enrollment continues in ROSELLA – 360-patient pivotal Phase 3 trial of relacorilant plus nab-paclitaxel in patients with recurrent, platinum-resistant ovarian cancer
Enrollment continues in open-label, Phase 1b trial of relacorilant plus pembrolizumab in patients with adrenal cancer with cortisol excess
Randomized, placebo-controlled Phase 2 trial of relacorilant plus enzalutamide in patients with prostate cancer expected to begin by mid-year in collaboration with the University of Chicago
"We and our investigators are excited to advance relacorilant in platinum-resistant ovarian cancer. Relacorilant plus nab-paclitaxel has the potential to become a new standard of care for the treatment of patients with this dire disease. We are on track to complete enrollment in ROSELLA by the end of this year," said Dr. Guyer.

Amyotrophic Lateral Sclerosis (ALS)

Enrollment continues in DAZALS – 198-patient, randomized, double-blind, placebo-controlled Phase 2 trial of dazucorilant in patients with ALS
"ALS, commonly known as Lou Gehrig’s disease, is a devastating illness with an urgent need for better treatment. We are conducting our DAZALS study in collaboration with TRICALS, the leading ALS academic consortium in Europe, to investigate dazucorilant’s potential to significantly improve the lives of patients with ALS. We are on track to complete enrollment in DAZALS by early 2024," said Dr. Guyer.

Non-alcoholic Steatohepatitis (NASH)

Enrollment completed in Phase 1b dose-finding trial of miricorilant in patients with presumed NASH – data expected by mid-year; Phase 2b trial to begin in the fourth quarter
"Miricorilant, a potent, oral, selective cortisol modulator with targeted activity in the liver, continues to demonstrate great promise as a treatment for NASH. Our Phase 1b study has identified a range of doses, all substantially lower than our originally tested doses, that significantly reduce liver fat without causing excessive liver irritation," said Dr. Guyer. "We expect to share results from this study by mid-year and plan to start a Phase 2b trial in the fourth quarter of this year."

Conference Call

We will hold a conference call on May 3, 2023, at 5:00 p.m. Eastern Time (2:00 p.m. Pacific Time). Participants must register in advance of the conference call by clicking here. Upon registering, each participant will receive a dial-in number and a unique access PIN. Each access PIN will accommodate one caller. Additionally, a listen-only webcast will be available by clicking here. A replay of the call will be available on the Investors / Events tab of www.corcept.com.

Hypercortisolism

Hypercortisolism, often referred to as Cushing’s syndrome, is caused by excessive activity of the hormone cortisol. Endogenous Cushing’s syndrome is an orphan disease that most often affects adults aged 20-50. In the United States, an estimated 20,000 patients have Cushing’s syndrome, with about 3,000 new patients diagnosed each year. Symptoms vary, but most patients experience one or more of the following manifestations: high blood sugar, diabetes, high blood pressure, upper-body obesity, rounded face, increased fat around the neck, thinning arms and legs, severe fatigue and weak muscles. Irritability, anxiety, cognitive disturbances and depression are also common. Hypercortisolism can affect every organ system and can be lethal if not treated effectively. Corcept holds patents directed to the composition of relacorilant and the use of cortisol modulators, including Korlym, in the treatment of patients with hypercortisolism.