On July 29, 2024 Corcept Therapeutics Incorporated (NASDAQ: CORT), a commercial-stage company engaged in the discovery and development of medications to treat severe endocrinologic, oncologic, metabolic and neurologic disorders by modulating the effects of the hormone cortisol, reported its results for the quarter ended June 30, 2024 (Press release, Corcept Therapeutics, JUL 29, 2024, https://ir.corcept.com/news-releases/news-release-details/corcept-therapeutics-announces-second-quarter-financial-2 [SID1234645129]).

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Financial Results

Revenue of $163.8 million, a 39 percent increase over the same period in 2023
Increase in 2024 revenue guidance to $640 – $670 million, from $620 – $650 million
Net income per common share of $0.32 (diluted), compared to $0.25 in second quarter 2023
Cash and investments of $492.5 million as of June 30, 2024
"Once again, we had a record number of new Korlym prescribers and a record number of patients receiving Korlym this quarter. Physicians are increasingly aware that hypercortisolism is much more prevalent than was previously assumed, so they are screening more patients for the disorder," said Joseph K. Belanoff, MD, Corcept’s Chief Executive Officer. "From the launch of Korlym, we implemented a unique system of patient and physician support and have invested in multiple refinements over the past 12 years. Hypercortisolism is a complicated disease and the expertise we have developed is critical to the life-changing impact for patients who receive Korlym treatment."

Corcept’s second quarter 2024 revenue was $163.8 million, compared to $117.7 million in the second quarter of 2023. Second quarter operating expenses were $128.2 million, compared to $88.1 million in the second quarter of 2023, due to increased spending on clinical trials and sales and marketing activities and to support the expansion of our commercial and clinical development teams. Net income was $35.5 million in the second quarter of 2024 compared to $27.5 million in the same period last year. Cash and investments were $492.5 million at June 30, 2024 compared to $451.0 million at March 31, 2024.

The company increased its 2024 revenue guidance to $640 – $670 million.

Clinical Development

"During the second quarter we presented the results from our GRACE and CATALYST trials. GRACE’s positive results are a welcome development for patients with hypercortisolism and constitute a significant step toward our new drug application for relacorilant, which we expect to submit in the fourth quarter. In addition, the results from the prevalence phase of our CATALYST study establish that hypercortisolism is a driving biological force in patients with diabetes refractory to treatment. We expect data from the treatment phase of the CATALYST study, as well as our other late-stage studies, GRADIENT, ROSELLA and DAZALS, by the end of this year," added Dr. Belanoff.

Cushing’s Syndrome

GRACE – Phase 3 trial of relacorilant in 152 patients with all etiologies of hypercortisolism – primary endpoint achieved in randomized withdrawal phase; open-label phase demonstrated clinically meaningful and statistically significant improvements in hypertension, hyperglycemia, weight, lean muscle mass, waist circumference, cognitive impairment and quality of life
Relacorilant New Drug Application (NDA) – NDA submission for Cushing’s syndrome expected in the fourth quarter
GRADIENT – Phase 3 trial of relacorilant in 137 patients with Cushing’s syndrome caused by adrenal adenomas – enrollment completed; results expected in the fourth quarter
CATALYST – Phase 4 trial examining the prevalence of hypercortisolism in patients with difficult-to-control type 2 diabetes – in the first 1,055 patients enrolled, 24% were found to have hypercortisolism; 136 patients with hypercortisolism entered a randomized, double-blind, placebo-controlled study of Korlym – treatment phase results expected in the fourth quarter
"Relacorilant has demonstrated tremendous promise as a treatment for patients with Cushing’s syndrome. Patients in GRACE’s open-label phase experienced significant improvements across a broad range of clinically meaningful endpoints, without significant safety burden. In the randomized withdrawal phase, GRACE met its primary endpoint and demonstrated that patients who remained on relacorilant maintained these improvements while those who received placebo saw a significant worsening in their signs and symptoms of hypercortisolism," said Bill Guyer, PharmD, Corcept’s Chief Development Officer.

"Our Phase 4 CATALYST trial is the largest and most rigorous study ever conducted to establish the prevalence of hypercortisolism in patients with difficult-to-control diabetes. The prevalence results from CATALYST confirm there are considerably more patients with Cushing’s syndrome than was previously assumed. CATALYST is poised to become the landmark study that guides physicians toward expanded screening for hypercortisolism and will result in better health outcomes for many patients who are struggling today," said Dr. Guyer.

Oncology

ROSELLA – Pivotal Phase 3 trial of relacorilant plus nab-paclitaxel in 381 patients with platinum-resistant ovarian cancer – enrollment completed; results expected in the fourth quarter
Open-label, Phase 1b trial of relacorilant plus pembrolizumab in 14 patients with advanced adrenal cancer with cortisol excess – improvement in Cushing’s syndrome signs and symptoms observed; no change in tumor progression
Randomized, placebo-controlled, Phase 2 trial of relacorilant plus enzalutamide in patients with prostate cancer in collaboration with the University of Chicago – enrollment continues
"Relacorilant has the potential to become the standard of care for patients with platinum-resistant ovarian cancer. If our pivotal ROSELLA trial replicates the positive results from our large, controlled, Phase 2 study, it will constitute a major medical advance. We expect progression-free survival data, ROSELLA’s primary endpoint, by the end of this year," said Dr. Guyer.

Amyotrophic Lateral Sclerosis (ALS)

DAZALS – Randomized, double-blind, placebo-controlled, Phase 2 trial of dazucorilant in 249 patients with ALS – enrollment completed; results expected in the fourth quarter
"Dazucorilant showed great promise in an animal model of ALS – improving motor performance and reducing neuroinflammation and muscular atrophy. We expect data by the end of this year and are hopeful that the trial results will create a much-needed advance for patients with ALS," said Dr. Guyer.

Metabolic Dysfunction-Associated Steatohepatitis (MASH)

MONARCH – Randomized, double-blind, placebo-controlled, Phase 2b trial of miricorilant with a cohort of patients with biopsy-confirmed MASH and a second cohort of patients with presumed MASH based on non-invasive diagnostic tests – enrollment continues
"In our Phase 1b study, miricorilant reduced liver fat very rapidly, improved liver health and key metabolic and lipid measures, and was well-tolerated. We look forward to building on these promising results in our MONARCH study," said Dr. Guyer. "Miricorilant has the potential to greatly benefit the millions of patients with MASH."

Conference Call

We will hold a conference call on July 29, 2024, 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 Corcept.com.