On November 1, 2023 Corcept Therapeutics Incorporated (NASDAQ: CORT), a commercial-stage company engaged in the discovery and development of medications to treat severe endocrine, oncology, metabolism and neurology disorders by modulating the effects of the hormone cortisol, reported results for the quarter ended September 30, 2023 (Press release, Corcept Therapeutics, NOV 1, 2023, https://ir.corcept.com/news-releases/news-release-details/corcept-therapeutics-announces-third-quarter-financial-results-2 [SID1234636629]).

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Financial Results

Revenue of $123.6 million, a 22 percent increase from third quarter 2022
Increase in 2023 revenue guidance to $470 – $480 million, from $455 – $470 million
Net income per common share of $0.28 (diluted), compared to $0.30 in third quarter 2022
Cash and investments of $414.8 million as of September 30, 2023
"Our strong results in the third quarter reflect returns on our substantial investment in helping physicians to better recognize and treat hypercortisolism. As screening for hypercortisolism (Cushing’s syndrome) becomes more common, the number of patients receiving medical therapy grows. We are confident this trend will continue. 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 raising our 2023 revenue guidance again, to $470 – $480 million," said Joseph K. Belanoff, MD, Corcept’s Chief Executive Officer.

Corcept’s third quarter 2023 revenue was $123.6 million, compared to $101.7 million in the third quarter of 2022. Third quarter operating expenses were $92.4 million, compared to $69.8 million in the third quarter of 2022, due to increased clinical trial activity and expenses to support the expansion of our clinical development and commercial teams. Net income was $31.4 million in the third quarter of 2023 compared to $34.6 million in the same period last year.

Cash and investments were $414.8 million at September 30, 2023 compared to $363.3 million at the end of the prior quarter.

Clinical Development

"We are also very excited by the potential of our clinical development programs, with important milestones approaching. In 2024, we expect to report data from our trials in Cushing’s syndrome (the GRACE, GRADIENT and CATALYST studies), ovarian cancer (ROSELLA) and ALS (DAZALS). We also plan to submit an NDA for relacorilant in Cushing’s syndrome and to complete enrollment of our Phase 2b MONARCH study in patients with NASH," added Dr. Belanoff.

Cushing’s Syndrome

GRACE – Phase 3 trial of relacorilant as a treatment for patients with all etiologies of Cushing’s syndrome – enrollment completed; new drug application (NDA) submission expected in the second quarter of 2024
GRADIENT – Phase 3 trial of relacorilant as a treatment for patients with Cushing’s syndrome caused by adrenal adenomas – continues enrollment; results expected in mid-2024
CATALYST – 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 – continues enrollment; prevalence phase results expected in first quarter of 2024 and full results by year-end 2024
"Relacorilant has tremendous promise as a treatment for patients with Cushing’s syndrome and we are eager to make it available," said Bill Guyer, PharmD, Corcept’s Chief Development Officer. "Additionally, our CATALYST trial has the potential to serve as a landmark study to guide physician’s understanding of Cushing’s syndrome. CATALYST is the largest study ever conducted to establish the prevalence of hypercortisolism in patients with difficult-to-control diabetes. We expect CATALYST’s findings to greatly enhance physicians’ ability to diagnose and treat the many patients with Cushing’s syndrome whose condition now frequently goes undiagnosed. We expect data from the prevalence phase of the CATALYST study by early next year."

Oncology

ROSELLA – 360-patient pivotal Phase 3 trial of relacorilant plus nab-paclitaxel in patients with recurrent, platinum-resistant ovarian cancer – continues enrollment; results expected by year-end 2024
Open-label, Phase 1b trial of relacorilant plus pembrolizumab in patients with adrenal cancer with cortisol excess – continues enrollment; results expected in early 2024
Randomized, placebo-controlled, Phase 2 trial of relacorilant plus enzalutamide in patients with prostate cancer – initiated in collaboration with the University of Chicago
"Our Phase 2 trial demonstrated the potential of relacorilant combined with nab-paclitaxel to become a new standard of care for the treatment of patients with platinum-resistant ovarian cancer. The results were published in June in The Journal of Clinical Oncology. Our pivotal ROSELLA trial aims to replicate those results. We expect data by the end of next year," said Dr. Guyer.

Amyotrophic Lateral Sclerosis (ALS)

DAZALS – 198-patient, randomized, double-blind, placebo-controlled, Phase 2 trial of dazucorilant in patients with ALS – continues enrollment; results expected by year-end 2024
"ALS, also known as Lou Gehrig’s disease, is a devastating illness with an urgent need for better treatment. We are conducting our DAZALS study at sites in Europe and the United States to investigate dazucorilant’s potential to significantly improve the lives of patients with ALS. We expect data from this study by the end of next year," said Dr. Guyer.

Non-alcoholic Steatohepatitis (NASH)

MONARCH – 150-patient, randomized, double-blind, placebo-controlled, Phase 2b trial of miricorilant in patients with biopsy-confirmed NASH – initiated in October 2023
"We intend MONARCH to build on the promising results of our Phase 1b study, which demonstrated that miricorilant effectively reduces liver fat, improves liver health and key metabolic and lipid measures and is well-tolerated. Miricorilant has the potential to greatly benefit the millions of patients with NASH. We look forward to sharing our Phase 1b results and more details about MONARCH at a medical conference this fall," said Dr. Guyer.

Conference Call

We will hold a conference call on November 1, 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.