cept Therapeutics rporated(US:CORT)2025-11-04 21:12Product Development and Trials - The company has marketed Korlym in the U.S. since 2012 for treating hypercortisolism, with an authorized generic version launched in June 2024[76]. - In the CATALYST study, 23.8% of 1,057 patients with difficult-to-control diabetes were found to have hypercortisolism, with Korlym showing a statistically significant HbA1c reduction of 1.47% compared to 0.15% for placebo (p-value: < 0.0001)[78]. - The MOMENTUM trial, initiated in March 2025, aims to enroll 1,000 patients to assess hypercortisolism prevalence in resistant hypertension[80]. - Relacorilant, a selective cortisol modulator, has been submitted for FDA approval with a PDUFA date of December 30, 2025, based on positive results from the GRACE and GRADIENT trials[84]. - In the GRACE trial, patients experienced a mean systolic blood pressure reduction of 7.9 mm Hg and a 63% response rate in hypertension[86]. - The GRADIENT study showed a placebo-adjusted reduction in fasting glucose of 22.2 mg/dL (p-value: 0.002) for patients receiving relacorilant[93]. - The company submitted an NDA for relacorilant in combination with nab-paclitaxel for platinum-resistant ovarian cancer, with a PDUFA date of July 11, 2026[98]. - The ROSELLA trial enrolled 381 women with recurrent ovarian cancer, assessing progression-free survival and overall survival as dual primary endpoints[99]. - The Phase 2 trial, BELLA, is enrolling 90 patients with platinum-resistant ovarian cancer to evaluate the efficacy and safety of relacorilant combined with nab-paclitaxel and bevacizumab[106]. - An interim analysis indicated a 31% reduction in risk of death for patients receiving relacorilant plus nab-paclitaxel, with a median overall survival of 16.0 months compared to 11.5 months for nab-paclitaxel alone[101]. - The Phase 2 trial DAZALS for ALS showed a statistically significant 84% reduction in risk of death for patients receiving 300 mg of dazucorilant compared to placebo[113]. - The Phase 2b trial MONARCH for miricorilant in patients with MASH has completed enrollment in two cohorts, with 82 patients in Cohort A and 93 patients in Cohort B[116]. - The FDA has granted dazucorilant Fast Track Designation and orphan drug status for the treatment of ALS in the United States[115]. Financial Performance - Net product revenue for Q3 2025 was $207.6 million, a 13.8% increase from $182.5 million in Q3 2024, driven by a 42.5% increase in sales volume[122]. - For the nine months ended September 30, 2025, net product revenue reached $559.3 million, up 13.4% from $493.2 million in the same period of 2024[122]. - Cost of sales for Q3 2025 was $4.6 million, representing 2.2% of revenue, compared to 1.6% in Q3 2024, primarily due to a $1.0 million write-off of scrapped inventory[124]. - Research and development expenses for Q3 2025 totaled $68.8 million, a 16.0% increase from $59.3 million in Q3 2024, attributed to advancing development programs and employee compensation[126]. - Selling, general and administrative expense increased to $124.0 million for Q3 2025 from $73.7 million in Q3 2024, and for the nine months ended September 30, 2025, it was $318.5 million compared to $196.9 million in 2024[129]. - Interest and other income decreased to $5.0 million for Q3 2025 from $6.3 million in Q3 2024, and for the nine months ended September 30, 2025, it was $16.2 million compared to $17.8 million in 2024[131]. - Income tax benefit for Q3 2025 was $4.4 million, compared to an expense of $5.7 million in Q3 2024, and for the nine months ended September 30, 2025, it was $18.8 million compared to $19.1 million in 2024[132]. - The company expects higher research and development and selling, general and administrative expenses in 2025 compared to 2024 due to advancing clinical programs and increased commercialization efforts[128][130]. Cash Flow and Assets - As of September 30, 2025, cash, cash equivalents, and marketable securities totaled $524.2 million, down from $603.2 million as of December 31, 2024[135]. - Net cash provided by operating activities was $103.5 million for the nine months ended September 30, 2025, compared to $138.2 million in the same period of 2024[137]. - Net cash provided by investing activities was $81.6 million for the nine months ended September 30, 2025, compared to net cash used of $113.2 million in 2024[138]. - Net cash used in financing activities was $189.2 million for the nine months ended September 30, 2025, compared to $23.8 million in 2024, with $209.3 million spent on share repurchases[139]. - Retained earnings as of September 30, 2025, were $619.1 million[140]. Regulatory and Legislative Impact - The FDA and European Commission have designated relacorilant as an orphan drug, providing benefits such as tax credits and exclusive marketing rights[96]. - The Inflation Reduction Act of 2022 may materially reduce profits starting in 2026 due to provisions limiting revenue from Medicare patients[118].