cept Therapeutics rporated(CORT)2023-10-31 16:00Cushing's Syndrome Treatments - Korlym is marketed in the United States for treating Cushing's syndrome, with a focus on patient access through specialty pharmacy and distributor support, alongside patient assistance programs[96] - Relacorilant, a selective cortisol modulator, is in Phase 3 trials (GRACE and GRADIENT) for Cushing's syndrome, with 152 patients enrolled in GRACE and 130 planned for GRADIENT[97][98][99] - The GRADIENT trial aims to study relacorilant's effects on glucose metabolism and hypertension in patients with benign adrenal tumors, with half receiving the drug and half receiving placebo for 22 weeks[99] - Relacorilant has been designated as an orphan drug by the FDA and EC, offering tax credits, reduced fees, and exclusive marketing rights for 7 years in the U.S. and 10 years in the EU[114] - The CATALYST Phase 4 study aims to evaluate the prevalence of Cushing's syndrome in up to 1,000 patients with difficult-to-control diabetes, with potential randomization to Korlym or placebo for 24 weeks[111] Financial Performance and Expenses - Stock-based compensation expense for 2023 totaled 36.0 million for the nine months, compared to 32.1 million in 2022, respectively[103] - Income tax expense for the three and nine months ended September 30, 2023, was 13.0 million, respectively, compared to a benefit of 7.1 million in 2022[106] - Research and development expenses for the three and nine months ended September 30, 2023, were 11.2 million, respectively, compared to 9.7 million in 2022[103] Stock Options and Compensation - As of September 30, 2023, the company had 23.3 million stock options, 0.1 million RSUs, and 0.7 million RSAs outstanding, compared to 23.5 million, 0.2 million, and 0.2 million in 2022[105] Tax and R&D Regulations - The Tax Cuts and Jobs Act of 2017 requires U.S. and foreign R&D expenditures to be amortized over five and fifteen years, respectively, with no modifications as of September 30, 2023[108]