On May 1, 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 March 31, 2024 (Press release, Corcept Therapeutics, MAY 1, 2024, https://ir.corcept.com/news-releases/news-release-details/corcept-therapeutics-announces-first-quarter-financial-results-1 [SID1234642507]).

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Financial Results

Revenue of $146.8 million, a 39 percent increase over the same period in 2023
Increase in 2024 revenue guidance to $620 – $650 million, from $600 – $630 million
Net income per common share of $0.25 (diluted), compared to $0.14 in first quarter 2023
Cash and investments of $451.0 million as of March 31, 2024
"There were a record number of new Korlym prescribers in the first quarter and a record number of patients receiving Korlym. 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. "When Korlym is prescribed, we use the expertise and infrastructure that we have developed and refined over many years to support physicians and patients. This additional care helps create a life-changing impact for patients who receive Korlym treatment."

Corcept’s first quarter 2024 revenue was $146.8 million, compared to $105.7 million in the first quarter of 2023. First quarter operating expenses were $117.3 million, compared to $90.8 million in the first quarter of 2023, due to increased clinical trial activity and expenses to support the expansion of our commercial team. Net income was $27.8 million in the first quarter of 2024 compared to $15.9 million in the same period last year. Cash and investments were $451.0 million at March 31, 2024 compared to $425.4 million at December 31, 2023.

The company increased its 2024 revenue guidance to $620 – $650 million.

Clinical Development

"The results of the open-label phase of our GRACE trial, which we released last week, are compelling," said Dr. Belanoff. "We expect to build on these results in the trial’s randomized withdrawal phase. Results from this portion of the study will be available in the coming weeks. We are on track to submit our NDA for relacorilant in Cushing’s syndrome by the end of this quarter.

"In addition, we have completed enrollment in all our other late-stage studies – GRADIENT, CATALYST, ROSELLA and DAZALS. We expect that these studies will provide potent evidence that cortisol modulation is a powerful therapeutic mechanism with activity in many serious disorders," added Dr. Belanoff. "We expect data from these trials by the end of this year."

Cushing’s Syndrome

GRACE – Phase 3 trial of relacorilant in patients with all etiologies of hypercortisolism – open-label phase demonstrated clinically meaningful and statistically significant improvements in hypertension, hyperglycemia, weight, waist circumference, cognitive impairment and quality of life; results from randomized withdrawal phase expected this quarter
Relacorilant New Drug Application (NDA) – NDA submission for Cushing’s syndrome expected this quarter
GRADIENT – Phase 3 trial of relacorilant in 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; patients with hypercortisolism may enter a randomized, double-blind, placebo-controlled study of Korlym – enrollment completed; preliminary results: approximately 25% of patients enrolled were found to have hypercortisolism; full prevalence phase results expected this quarter and treatment phase results expected by year-end
"Relacorilant has demonstrated tremendous promise as a treatment for patients with Cushing’s syndrome. Patients in GRACE’s open-label phase exhibited significant improvements across a broad range of clinically meaningful endpoints, without significant safety burden. All patients have now completed the randomized withdrawal phase of the study. We plan to present data from both the open-label and randomized withdrawal phases of the study at a medical conference in June," said Bill Guyer, PharmD, Corcept’s Chief Development Officer.

"Our CATALYST trial is the largest and most rigorous study ever conducted to establish the prevalence of hypercortisolism in patients with difficult-to-control diabetes. We believe that CATALYST will be a landmark study to guide physicians as they identify and treat patients with hypercortisolism. We will present final results from the prevalence phase at the American Diabetes Association’s 84th Scientific Sessions in June," said Dr. Guyer.

Oncology

ROSELLA – Pivotal Phase 3 trial of relacorilant plus nab-paclitaxel in patients with platinum-resistant ovarian cancer – enrollment completed; results expected by year-end
Open-label, Phase 1b trial of relacorilant plus pembrolizumab in patients with adrenal cancer with cortisol excess – enrollment completed; results expected by mid-year
Randomized, placebo-controlled, Phase 2 trial of relacorilant plus enzalutamide in patients with prostate cancer in collaboration with the University of Chicago – enrollment continues
"Fully enrolling ROSELLA takes us a big step closer to addressing the unmet medical need of women with platinum-resistant ovarian cancer. Relacorilant has the potential to become the standard of care for patients with this devastating disease. 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 patients with ALS – enrollment completed; results expected by year-end
"Better treatments for ALS are urgently needed. Dazucorilant showed great promise in an animal model of ALS – improving motor performance and reducing neuroinflammation and muscular atrophy. Fully enrolling DAZALS is an important step toward understanding dazucorilant’s potential for significantly improving outcomes for people living with this devastating disease. We expect data by the end of this year," said Dr. Guyer.

Non-alcoholic Steatohepatitis (NASH)

MONARCH – Randomized, double-blind, placebo-controlled, Phase 2b trial of miricorilant in patients with biopsy-confirmed NASH – 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. "This drug has the potential to greatly benefit the millions of patients with NASH."

Conference Call

We will hold a conference call on May 1, 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.