Document

加州红木城, （纳斯达克：CORT）商业阶段公司corcept医疗从事通过调节皮质醇荷尔蒙影响来发现和开发治疗严重内分泌、肿瘤、代谢和神经系统疾病的药物，今天公布了截至2024年9月30日的季度结果。

「在第三季度，我们增加了更多的 Korlym® 处方人员和患者接受了 Korlym 治疗的比以往任何时候都更多，」康塞普行政总裁博士约瑟夫·贝拉诺夫表示。「医生越来越意识到高血管症的真正普遍性以及未治疗的患者的健康结果不佳。筛查越来越普遍，接受适当护理的患者数量继续增加。对于选择 Korlym 的患者和医生来说，我们广泛的支持服务系统对于优化我们药物的益处至关重要。」

Corcept在2024年第三季的营业收入为18250万美元，较2023年第三季的12360万美元增加。第三个季度第三季度营业费用为13590万美元，较2023年第三季的9240万美元增加。净利润在2024年第三季度为4720万美元，相较去年同期的3140万美元。

截至二零二四年九月三十日，现金和投资额为 547.6 万美元，而当时的现金和投资额为 4.92.5 亿美元二零二四年六月三十日。2024 年 9 月 30 日的余额反映收购 23.4 万美元普通股（870,000 股份) 在第三根据公司股票回购计划的季度，行使雇员股票期权净额及限制股份授权净授权。

「我们的临床开发计划已经为我们在第四季度带来变革奠定了基础，」贝兰诺夫博士补充说。「我们预计会在年底前提交对于relacorilant作为库欣氏综合症（Cushing's syndrome）患者治疗的新药申请。我们还预期将会在年底前公布(i)我们在库欣氏综合症患者中进行CATALYSt研究的治疗阶段数据，(ii)在对于铂金抗性卵巢癌的女性中进行的我们的关键性研究ROSELLA的数据，以及(iii)我们在肌萎缩性脊髓侧索硬化症（ALS）患者中进行的DAZALS研究的数据。」

•GRACE - relacorilant在152名具有Cushing氏症各种病因的患者中进行的至关重要的3期试验 - 所有板块达到随机撤退阶段的主要终点；开放标签阶段展示在广泛范围高皮质醇症征和症状方面具有临床意义的改善； relacorilant耐受性良好，没有relacorilant诱导的低钾血症、子宫内膜肥厚或相关的阴道出血、肾上腺功能不全或QT延长

•GRADIENt – NDA的支持性试验数据–在一项涉及137位库欣氏症患者、由肾上腺病理引起的库欣氏症的随机、双盲、安慰剂对照的第3期试验中，接受relacorilant治疗的患者在许多高皮质醇症的体征和症状上呈现出临床上有意义的改善；relacorilant的耐受性良好，其安全剖面与GRACE研究一致，其中没有relacorilant引起的低钾血症、子宫内膜肥厚或有关的阴道出血、肾上腺功能不全或QT间期延长的病例。

“GRADIENT的阳性结果在库欣综合症患者身上确认了relacorilant作为对治疗这种致命疾病的重大医疗进步的承诺。正如在GRACE研究中的情况一样，GRADIENt中接受relacorilant的患者在多种高皮质醇症的表征和症状上经历了临床意义深远的改善，而且没有出现目前批准的治疗对患者可能带来的一些严重不良影响，”Corcept公司的首席发展官Bill Guyer，药学博士表示。「这些数据将是relacorilant的新药申请的强有力补充，我们计划在年底前提交该申请。」

GRACE试验的关键第3阶段是relacorilant在库欣氏症的NDA基础，并达到其主要终点。在GRACE的初始、开放式阶段中，患有库欣氏症的患者在高血压、高血糖和其他症状方面均有临床意义和统计学意义的改善。在随机撤回阶段中，GRACE达到其主要终点，并证明那些继续使用relacorilant的患者保持了这些改善，而那些接受安慰剂的患者则在其高皮质醇症的表征和症状中看到了明显恶化。符合其已知的安全性档案，relacorilant在GRACE的两个阶段中均耐受良好。

作为relacorilant在库欣氏症的新药申请(NDA)的一部分，为期22周的第3期GRADIENt研究支持了GRACE试验，进一步证明了relacorilant的有效性和安全性。接受GRADIENt研究中relacorilant治疗的患者，相较于基线，临床上意义深远且在统计上显著改善了高血压、高血糖、体重和体组成，而接受安慰剂的患者则没有。试验的主要终点是与安慰剂相比的收缩压(SBP)改善，高血糖、体重和体组成则是次要终点。

参加GRADIENt且患有高血压的患者，在22周接受relacorilant后，平均SBP有显著并具临床意义的改善（下降6.6 mm Hg；p值：0.012），与基准相比。接受安慰剂的患者则没有（降低2.1 mm Hg；p值：ns），与基准相比。接受relacorilant和安慰剂之间的比较在统计意义上不具有显著差异。研究期间，5名接受安慰剂的患者需要使用抗高血压药物进行救助措施，而只有1名接受relacorilant的患者需要。为确保准确性，高血压是通过24小时动态血压监测来进行测量。

接受瑞拉康肽治疗的高血糖患者在22周时，葡萄糖代谢有显著及具有临床意义的改善，包括空腹血糖（安慰剂调整后减少22.2 mg/dL；p值：0.002）、口服葡萄糖耐量试验曲线下面积（安慰剂调整后减少2.6 h*mmol/L；p值：0.046）和血红素A1c（安慰剂调整后减少0.3％；p值：0.019），相较于接受安慰剂的患者。

Patients in GRADIENT who received relacorilant experienced clinically meaningful and statistically significant improvements at 22 weeks in body weight (placebo-adjusted reduction of 3.9 kg; p-value: 0.0001) and both visceral adipose fat mass and volume (p-values: 0.018 and 0.016, respectively), compared to those who received placebo.

Relacorilant was well tolerated in GRADIENT, with side effects consistent with those seen in its Phase 2 and GRACE trials. Across all of these studies, the most common adverse events were mild-to-moderate nausea, edema, pain in extremities and back, and fatigue – all symptoms associated with the “cortisol withdrawal” many patients experience following surgery or start of medical therapy for Cushing’s syndrome. Importantly, there were

“We are also looking forward to results from the treatment phase of our CATALYST study by year-end,” continued Dr. Guyer. “CATALYST is the largest and most rigorous study ever conducted of hypercortisolism in patients with difficult-to-control diabetes. CATALYST’s prevalence results confirm there are many more patients with Cushing’s syndrome than was previously assumed and the trial is poised to be a landmark study in the identification and treatment of patients with hypercortisolism. We are confident it will lead to better health outcomes for many patients who are struggling today.”

•Early-stage prostate cancer – Enrollment continues in randomized, placebo-controlled, Phase 2 trial of relacorilant plus enzalutamide in patients with early-stage prostate cancer, conducted in collaboration with the University of Chicago

“Relacorilant has the potential to become the standard of care for patients with platinum-resistant ovarian cancer. If ROSELLA replicates the positive results of our large, controlled, Phase 2 study, it will constitute a major medical advance and serve as the basis for relacorilant’s next NDA. We expect progression-free survival data, ROSELLA’s primary endpoint, by the end of this year,” said Dr. Guyer.

“ALS is a dire disease, with few good treatment options. Our selective cortisol modulator dazucorilant showed great promise in an animal model of ALS, improving motor performance and reducing neuroinflammation and muscular atrophy. We expect data regarding DAZALS’s primary endpoint – improvement in patients’ ALS Functional Rating Scale-Revised (ALSFRS-R) score – by the end of this year. We hope DAZALS will lead to a much-needed advance for patients with ALS,” said Dr. Guyer.

“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.”

We will hold a conference call on October 30, 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.

For over 25 years, Corcept’s focus on cortisol modulation and its potential to treat patients with a wide variety of serious disorders has led to the discovery of more than 1,000 proprietary selective cortisol modulators. Corcept is conducting advanced clinical trials in patients with hypercortisolism, solid tumors, ALS and liver disease. In February 2012, the company introduced Korlym, the first medication approved by the U.S. Food and Drug Administration for the treatment of patients with Cushing’s syndrome. Corcept is headquartered in Redwood City, California. For more information, visit Corcept.com.

Statements in this press release, other than statements of historical fact, are forward-looking statements based on our current plans and expectations that are subject to risks and uncertainties that might cause our actual results to differ materially from those such statements express or imply. These risks and uncertainties include, but are not limited to, risks related to the sale and reimbursement of Korlym and our ability to operate our business successfully in a competitive and closely regulated market; risks related to the study and development of Korlym, relacorilant, dazucorilant, miricorilant and our other product candidates, including their clinical attributes and applicable regulatory approvals, mandates, oversight and other government requirements; general litigation risks; and the scope and protective power of our intellectual property. These and other risks are set forth in our SEC filings, which are available at our website and the SEC’s website.

In this press release, forward-looking statements include those concerning: trends in medical practice, including trends regarding the identification and treatment of patients with hypercortisolism; our revenue growth and 2024 revenue guidance; the development of relacorilant as a treatment for patients with Cushing’s syndrome and solid tumors, dazucorilant as a treatment for patients with ALS, miricorilant as a treatment for patients with MASH; the timing and outcome of relacorilant’s NDA in Cushing’s syndrome; the timing of and expectations regarding our CATALYST, ROSELLA, DAZALS and MONARCH trials and the possibility of relacorilant, dazucorilant and miricorilant being approved for the treatment of any disorder; and the accrual and attributes of our clinical data and the timing and content of our regulatory submissions. We disclaim any intention or duty to update forward-looking statements made in this press release.


	September 30, 2024		December 31, 2023(1)
	(Unaudited)
Assets
Cash and investments	$	547,646	$	425,397
Trade receivables, net of allowances	59,717		41,123
Insurance recovery receivable related to Melucci litigation	—		14,000
Inventory	15,814		15,974
Operating lease right-of-use asset	5,503		120
Deferred tax assets, net	126,799		90,605
Other assets	28,778		34,298
Total assets	$	784,257	$	621,517
Liabilities and Stockholders’ Equity
Accounts payable	$	18,584	$	17,396
Accrued settlement related to Melucci litigation	—		14,000
Operating lease liabilities	6,791		151
Other liabilities	120,047		83,265
Stockholders’ equity	638,835		506,705
Total liabilities and stockholders’ equity	$	784,257	$	621,517

(1) Derived from audited financial statements at that date


	Three Months Ended				Nine Months Ended
	September 30,				September 30,
	2024		2023		2024		2023
Revenues
Product revenue, net	$	182,546	$	123,601	$	493,150	$	346,970

Operating expenses
Cost of sales	2,867		1,645		7,926		4,604
Research and development	59,336		45,517		176,587		129,646
Selling, general and administrative	73,745		45,262		196,948		137,107
Total operating expenses	135,948		92,424		381,461		271,357
Income from operations	46,598		31,177		111,689		75,613
Interest and other income	6,345		5,208		17,844		12,135
Income before income taxes	52,943		36,385		129,533		87,748
Income tax expense	(5,730)		(5,007)		(19,070)		(12,963)
Net income	$	47,213	$	31,378	$	110,463	$	74,785

Net income attributable to common stockholders	$	46,690	$	31,172	$	109,344	$	74,353

Basic net income per common share	$	0.45	$	0.31	$	1.06	$	0.72

Diluted net income per common share	$	0.41	$	0.28	$	0.98	$	0.66

Weighted-average shares outstanding used in computing net income per common share
Basic	103,371		102,014		103,094		103,933
Diluted	113,723		111,099		111,571		112,054