Corcept Therapeutics Inc (CORT) 2024 Q3 法說會逐字稿

Good day and thank you for standing by. Welcome through the course of therapeutic conference call at this time. (Operator Instructions) Please be advised that today's conference is being recorded. Alright, to hand the conference over to your first speaker today. Atabak Mokari, Chief Financial Officer. Please go ahead.

美好的一天，感謝您的支持。歡迎此時參加治療電話會議的過程。（操作員指示）請注意，今天的會議正在錄製中。好的，今天的會議交給第一位發言人。阿塔巴克·莫卡里，財務長。請繼續。

Hello Everyone. Good afternoon. And thank you for joining us today. We issued a press release announcing our financial results for the third quarter and providing a corporate update. A copy is available at Corcept.com. Our complete financial results will be available when we file our Form 10-Q with the SEC.

大家好。午安.感謝您今天加入我們。我們發布了新聞稿，宣布了第三季的財務業績並提供了公司最新情況。可在 Corcept.com 上取得副本。當我們向 SEC 提交 10-Q 表格時，即可獲得完整的財務結果。

Today's call is being recorded. The replay will be available at the investors past events, tab of our website statements during this call, other than statements of historical fact are forward-looking statements based on our plans and expectations that are subject to risks and uncertainties which might cause actual results to be materially different from those such statements expressed or implied.

今天的通話正在錄音。投資者將可以在過去的事件中重播，本次電話會議期間我們網站上的聲明選項卡，除了歷史事實的聲明外，都是基於我們的計劃和預期的前瞻性聲明，這些聲明受到風險和不確定性的影響，可能會導致實際結果發生變化。

These forward-looking statements are described in today's press release and the risks and uncertainties that may affect them are described in the press release. And our annual report on Form 10-K and our quarterly reports on Form 10-Q, all of which are publicly available at the Sec's website. Please refer to those documents for additional information. We disclaim any intention or duty to update forward-looking statements.

今天的新聞稿中描述了這些前瞻性陳述，並在新聞稿中描述了可能影響這些陳述的風險和不確定性。我們的 10-K 表格年度報告和 10-Q 表格季度報告，所有這些都可以在 SEC 網站上公開取得。請參閱這些文件以取得更多資訊。我們不承擔任何更新前瞻性陳述的意圖或義務。

Our revenue in the third quarter of 2024 was $182.5 million and an increase of 48% compared to the third quarter of last year. We expect our revenue growth to continue and have increased our 2024 revenue guidance to 675 to $700 million.

我們2024年第三季的營收為1.825億美元，比去年第三季成長48%。我們預計我們的收入將繼續成長，並將 2024 年收入指引上調至 6.75 至 7 億美元。

Net income was $47.2 million in the third quarter compared to $31.4 million in the third quarter of the prior year.

第三季淨利為 4,720 萬美元，而去年第三季淨利為 3,140 萬美元。

Our cash and investments at September 30th were $547.6 million compared to $492.5 million at June 30th.

截至 9 月 30 日，我們的現金和投資為 5.476 億美元，而 6 月 30 日為 4.925 億美元。

We acquired $23.4 million of our common stock in the third quarter. Pursuant to our stock repurchase program, the net exercise of stock options by Corcept employees and the net vesting of restricted stock grants. I will now turn the call over to Charlie Robb, our Chief Business Officer, Charlie.

我們在第三季收購了價值 2,340 萬美元的普通股。根據我們的股票回購計劃，Corcept 員工淨行使股票選擇權以及限制性股票授予的淨歸屬。我現在將把電話轉給我們的商務長查理羅伯（Charlie Robb）。

Thanks Atabak. I don't have much to report this quarter. As many of, you know, in March 2018, we sued Teva pharmaceuticals to stop it from marketing a generic version of quorum in violation of our patents. In December of last year, the court ruled against us appealed that decision to the Federal Circuit Court of Appeals briefing in the matter is complete. The documents are available at the government's Pacer website. And the next step is for the Federal Circuit to schedule oral argument.

謝謝阿塔巴克。本季我沒有太多要報告的內容。正如許多人所知，2018 年 3 月，我們起訴 Teva 製藥公司，阻止其銷售 Quorum 的仿製藥，侵犯了我們的專利。去年12月，法院作出不利於我們的上訴，該判決已向聯邦巡迴上訴法院通報此事。這些文件可在政府的 Pacer 網站上取得。下一步是聯邦巡迴法院安排口頭辯論。

The court could schedule or oral argument as early of as, as early as January of next year and issue a decision in the next quarter.

法院最早可以在明年一月安排或口頭辯論，並在下個季度做出裁決。

If we prevail TVOD lose FDA a approval of its product, and at least until the expiration of our patents in 2037 would be unable to market the product. As I've said before, we are eager to advance this appeal. We strongly believe that our position is correct and that the Federal Circuit with its deep expertise in patent law will agree.

如果我們獲勝，TVOD 將失去 FDA 對其產品的批准，並且至少在 2037 年我們的專利到期之前將無法銷售該產品。正如我之前所說，我們渴望推進這項呼籲。我們堅信我們的立場是正確的，並且擁有深厚專利法專業知識的聯邦巡迴法院將會同意。

I'll now turn the call over to Joe Belanoff, our Chief Executive Officer, Joe.

現在我將把電話轉給我們的執行長喬貝拉諾夫 (Joe Belanoff)。

Thank you Charlie and thank you everyone for joining us this afternoon. This is a very exciting time at Corcept. Physician Awareness and understanding of hypercortisolism is accelerating the results from our grace and gradient phase three studies clear the path for Rolland's new drug application in Cushing Syndrome, which we will submit by year end.

謝謝查理，也謝謝大家今天下午加入我們。這是 Corcept 非常令人興奮的時刻。醫生對皮質醇增多症的認識和理解正在加速我們的恩典和梯度第三階段研究的結果，為羅蘭在庫欣氏症候群中的新藥應用掃清了道路，我們將在年底提交該新藥。

Our phase four CATALYST trial in patients with Cushing's syndrome and difficult to treat diabetes will generate data this quarter. As will our trials in patients with ovarian cancer and Als success in these endeavors will transform the company.

我們針對庫欣氏症候群和難以治療的糖尿病患者進行的第四期 CATALYST 試驗將於本季產生數據。我們對卵巢癌患者進行的試驗以及 Als 在這些努力中取得的成功也將改變公司。

We ended the third quarter with another high in both the number of new quorum prescribers and the number of patients receiving treatment with quorum.

第三季結束時，新法定開處方者人數和接受法定人數治療的患者人數均創下新高。

More physicians are now aware that hypercortisolism is much more prevalent than was previously assumed as a result. They are screening and treating many more patients when quorum is prescribed, the expertise in infrastructure we have developed and refined over many years plays a critical role in helping patients and physicians achieve optimum benefit.

現在越來越多的醫生意識到皮質醇增多症比以前認為的更為普遍。當法定人數被規定時，他們正在篩選和治療更多的患者，我們多年來開發和完善的基礎設施專業知識在幫助患者和醫生實現最佳利益方面發揮著關鍵作用。

Our quorum business is thriving perhaps even more important. We've recently made substantial progress in the advancement of our proprietary selective cortisol modulator reliant. The story is not complicated. Patients in the grace and gradient studies experience meaningful improvements in hypertension, glucose control weight and body composition as well as other signs and symptoms of Cushing's syndrome.

我們的法定人數業務正在蓬勃發展，也許更為重要。最近，我們在開發專有的選擇性皮質醇調節劑依賴方面取得了實質進展。故事並不複雜。恩典和梯度研究中的患者在高血壓、血糖控制、體重和身體組成以及庫欣氏症候群的其他體徵和症狀方面都得到了有意義的改善。

Relacorilant was very well tolerated and did not cause some of the serious adverse events that can be caused by other medications used to treat Cushing's Syndrome. In particular hypokalemia, endometrial hypertrophy, its related vaginal bleeding, QT prolongation and adrenal insufficiency.

Relacorilant 的耐受性非常好，不會引起其他用於治療庫欣氏症候群的藥物可能引起的一些嚴重不良事件。特別是低血鉀、子宮內膜肥大、其相關的陰道出血、QT間期延長和腎上腺皮質功能不全。

As you recall, our pivotal phase three grace trial is the basis for Relacorilant NDA. In the trial's open label phase, 152 patients with Cushing's Syndrome and either hypertension hyperglycemia or both, received Relacorilant for 22 weeks.

您還記得，我們​​關鍵的第三階段寬限試驗是 Relacorilant NDA 的基礎。在該試驗的開放標籤階段，152 名患有庫欣氏症候群並患有高血壓、高血糖或兩者兼而有之的患者接受了 Relacorilant 治療 22 週。

Patients who met prespecified improvements were given the opportunity to enter the trial's randomized double blind withdrawal phase. In which half of the patients continued to receive Relacorilant and half received placebo for 12 weeks.

達到預定改善的患者有機會進入試驗的隨機雙盲退出階段。其中一半患者繼續接受 Relacorilant 治療，一半患者接受安慰劑治療 12 週。

Patients in the open label phase of grace exhibited clinically meaningful and statistically significant improvements in hypertension hyperglycemia, weight, lean muscle mass, waist circumference, cognition, cushioned quality of life score and other important clinical measures.

處於寬限期開放標籤階段的患者在高血壓、高血糖、體重、瘦肌肉質量、腰圍、認知、緩衝生活品質評分和其他重要臨床指標方面表現出具有臨床意義和統計顯著性的改善。

And in the randomized withdrawal phase of grace, which compared patients taking Relacorilant to those taking placebo grace met its primary endpoint of maintenance of blood pressure control. The odds ratio which is the study's primary endpoint was 0.17 with a p-value of 0.02. An odds ratio of 0.17 means that patients taking Relacorilant were six times more likely to maintain blood pressure response. Compared to those taking.

在 Grace 的隨機戒斷階段，對服用 Relacorilant 的患者與服用安慰劑的患者進行了比較，Grace 達到了維持血壓控制的主要終點。研究的主要終點比值比為 0.17，p 值為 0.02。優勢比為 0.17，表示服用 Relacorilant 的患者維持血壓反應的可能性是其他患者的六倍。與服用者相比。

In addition, patients who continue to take Relacorilant in the randomized withdrawal phase maintained the broad range of other improvements observed in the open label phase. While those who receive placebo experienced a significant worsening of their symptoms, these outcomes would on their own, provide powerful evidence for our NDA, but they do not stand on their own.

此外，在隨機戒斷階段繼續服用 Relacorilant 的患者保持了開放標籤階段觀察到的廣泛其他改善。雖然接受安慰劑的患者的症狀明顯惡化，但這些結果本身就可以為我們的 NDA 提供有力的證據，但它們並不是獨立存在的。

Today, we released results from our second phase three trial of Relacorilant and Cushing's Syndrome gradient. A 22 week randomized double blind placebo controlled study in 137 patients whose hypercortisolism is caused by an adrenal adenoma or adrenal hyperplasia. Patients with this type of Cushing's syndrome often experience a less rapid decline but their health outcomes are poor and include a significantly higher risk of premature death.

今天，我們發布了 Relacorilant 和庫欣氏症候群梯度第二階段三期試驗的結果。一項為期 22 週的隨機雙盲安慰劑對照研究，受試者為 137 名因腎上腺腺瘤或腎上腺增生引起的皮質醇增多症患者。患有這種類型的庫欣氏症候群的患者通常病情下降速度較慢，但他們的健康結果很差，且過早死亡的風險明顯較高。

Gradient data will support our NDA by providing further evidence of Relacorilant efficacy and safety, confirming what we found in grace. Patients treated with Relacorilant gradient exhibited clinically meaningful and statistically significant improvements in hypertension hyperglycemia weight and body composition compared to baseline. While patients who received placebo did not, the trial's primary endpoint was the improvement in systolic blood pressure compared to placebo with hyperglycemia weight and body composition as secondary end points.

梯度數據將透過提供 Relacorilant 功效和安全性的進一步證據來支持我們的 NDA，證實我們在 Grace 中的發現。與基線相比，接受 Relacorilant 梯度治療的患者在高血壓、高血糖、體重和身體組成方面表現出具有臨床意義和統計學顯著性的改善。雖然接受安慰劑的患者沒有這樣做，但該試驗的主要終點是與安慰劑相比收縮壓的改善，高血糖、體重和身體組成作為次要終點。

Patients with hypertension who received reliant had an improvement of 6.6 millimeters of mercury in their systolic blood pressure at 22 weeks compared to baseline with a p-value of 0.012. Patients who received placebo had an improvement of 2.1 millimeters of mercury in their systolic blood pressure at 22 weeks compared to baseline, a nonsignificant improvement.

接受 Reliant 治療的高血壓患者在 22 週時的收縮壓比基線改善了 6.6 毫米汞柱，p 值為 0.012。與基線相比，接受安慰劑的患者在 22 週時的收縮壓改善了 2.1 毫米汞柱，但改善並不顯著。

The difference in the improvement in hypertension in those who receive Relacorilant compared to those who received placebo was not statistically significant patients whose hypertension worsened substantially during the study were given rescue hypertension medications. Notably, five patients who received placebo required rescue medication while only one patient who received Relacorilant required it.

接受 Relacorilant 治療的患者與接受安慰劑治療的患者相比，高血壓改善的差異不具有統計學意義，而在研究期間高血壓嚴重惡化且接受了救援性高血壓藥物治療的患者中。值得注意的是，五名接受安慰劑的患者需要救援藥物，而只有一名接受 Relacorilant 的患者需要救援藥物。

Patients with hyperglycemia who received Relacorilant experienced clinically meaningful and statistically significant improvements in glucose metabolism compared to those who received placebo with placebo adjusted improvements in fasting glucose of 22 mg per deciliter p -value of 0.002 and hemoglobin A one c of 0.3% p-value of 0.019 at 22 weeks.

與接受安慰劑的患者相比，接受Relacorilant 治療的高血糖患者的葡萄糖代謝得到了具有臨床意義和統計學意義的顯著改善，安慰劑調整後的空腹血糖改善為22 毫克/分升，p 值為0.002，血紅素A one c 為0.3% p 值22 週時為 0.019。

Patients in gradient who receive Relacorilant also experience clinically meaningful and statistically significant improvements in body weight compared to those who receive placebo with a placebo adjusted weight loss of 3.9 kg and AP value of 0.0001 at 22 weeks.

與接受安慰劑的患者相比，接受Relacorilant 治療的梯度患者的體重也出現了具有臨床意義和統計學意義的顯著改善，第22 週時安慰劑調整後的體重減輕了3.9 kg，AP 值為0.0001。

An important feature of Relacorilant as how well it was tolerated in both grace and gradient. In both studies, the most common adverse events were mild to moderate nausea, pain in the extremities and back and fatigue. These symptoms are consistent with the cortisol withdrawal. Patients with hypercortisolism experience following a rapid reduction in cortisol activity, whether due to surgery that removes an act or cortisol secreting tumor or the start of medical therapy.

Relacorilant 的一個重要特徵是它在優雅和梯度方面的耐受性。在這兩項研究中，最常見的不良事件是輕度至中度噁心、四肢和背部疼痛以及疲勞。這些症狀與皮質醇戒斷症狀一致。皮質醇增多症患者會經歷皮質醇活性迅速降低的情況，無論是因為手術切除了分泌皮質醇的腫瘤或是開始藥物治療。

As expected, there were no Relacorilant induced instances of hypokalemia, endometrial hypertrophy or its related vaginal bleeding. No cases of adrenal insufficiency and no cases of QT prolongation.

如預期的那樣，沒有出現 Relacorilant 引起的低血鉀、子宮內膜肥大或其相關陰道出血的情況。沒有腎上腺功能不全的病例，也沒有 QT 延長的病例。

All of these adverse events can have serious health consequences and arise in patients taking the medications currently used to treat patients with hypercortisolism.

所有這些不良事件都可能產生嚴重的健康後果，並發生在服用目前用於治療皮質醇增多症的藥物的患者中。

The positive efficacy and safety results now supported by the global improvement seen in patients in the gradient study. Promise a great advance for patients with Cushing's Syndrome.

梯度研究中患者的整體改善證明了積極的療效和安全性結果。為庫欣氏症候群患者帶來巨大進步。

Concurrent with our work on Relacorilant's new drug application, we continue to look to further increase physician awareness and understanding of Cushing's syndrome.

在進行 Relacorilant 新藥應用工作的同時，我們繼續尋求進一步提高醫生對庫欣氏症候群的認識和理解。

Our phase four CATALYST study of patients with difficult to treat diabetes has produced potent evidence to help advance the field.

我們對難以治療的糖尿病患者進行的第四期 CATALYST 研究提供了有力的證據來幫助推動該領域的發展。

The prevalence results from CATALYST were presented in the American Diabetes Association's annual scientific sessions in June. They clearly demonstrated that there are significantly more patients with hypercortisolism than was previously recognized.

CATALYST 的盛行率結果已在 6 月的美國糖尿病協會年度科學會議上發表。他們清楚地表明，皮質醇增多症患者的數量比以前認識到的要多得多。

Of the 1st 1,055 patients enrolled in CATALYST, one in four were found to have hypercortisolism. This is a far higher prevalence rate than was assumed with large implications for patient care.

在第一批加入 CATALYST 的 1,055 名患者中，四分之一的患者被發現患有皮質醇增多症。這個盛行率比假設的要高得多，對病患照護有很大影響。

Hypercortisolism was even more common in patients in the study who in addition to their diabetes had already diagnosed cardiovascular disease, particularly in those who were using three or more medications to manage their hypertension.

在該研究中，除了糖尿病之外還已經診斷出心血管疾病的患者中，皮質醇增多症更為常見，尤其是那些使用三種或更多藥物來控制高血壓的患者。

More than a third of this group of patients were found to have hypercortisolism.

這群患者中有超過三分之一被發現有皮質醇增多症。

The second portion of the CATALYST study is ongoing in it. Patients with hypercortisolism are randomized to receive either quorum or placebo.

CATALYST 研究的第二部分正在進行中。皮質醇增多症患者被隨機分配接受法定人數或安慰劑治療。

The primary endpoint is the reduction in hemoglobin A1c between these groups. We expect results of this portion of the study by the end of the year.

主要終點是這些組別之間血紅蛋白 A1c 的降低。我們預計這部分研究的結果將在今年底得到。

As you know, we are also studying Relacorilant as a treatment for different types of cancer mediated by cortisol activity.

如您所知，我們也正在研究 Relacorilant 作為皮質醇活性介導的不同類型癌症的治療方法。

In our pivotal rosella study. 381 women with platinum resistant ovarian cancer have been randomized on a 1 to 1 basis to receive either Nab-paclitaxel, a medication often prescribed to women with platinum resistant disease or Nab-paclitaxel Relacorilant. Our expectation is that Relacorilant will re-sensitize ovarian tumors to the effects of chemotherapy by blunting the anti apoptotic effect of cortisol activity.

在我們的關鍵羅塞拉研究中。 381 名患有鉑類抗藥性卵巢癌的女性以1 比1 的比例隨機接受白蛋白結合型紫杉醇（一種通常為患有鉑類抗藥性疾病的女性開出的藥物）或白蛋白結合型紫杉醇Relacorilant 。我們的期望是，Relacorilant 將透過削弱皮質醇活性的抗細胞凋亡作用，使卵巢腫瘤對化療的作用重新敏感。

Rosella's design closely tracks the design of our successful controlled phase two trial.

Rosella 的設計與我們成功的受控二期試驗的設計密切相關。

In the phase two trial, women who received Relacorilant intermittently, the day before the day of and the day after they received Nab-paclitaxel, exhibited a statistically significant improvement in progression free survival and duration of response compared to the group who received Nab-paclitaxel monotherapy.

在第二階段試驗中，與接受白蛋白結合型紫杉醇治療組相比，在接受白蛋白結合型紫杉醇治療前一天和後一天間歇性接受Relacorilant 治療的女性在無進展生存期和反應持續時間方面表現出統計學上顯著的改善單一療法。

Women in the Relacorilant group also live longer than those in the comparator arm.

Relacorilant 組的女性也比對照組的女性壽命更長。

29% of the patients who took intermittent Relacorilant were alive two years after studies start versus only 14% who took Nab-paclitaxel alone.

間歇性服用 Relacorilant 的患者中有 29% 在研究開始兩年後仍存活，而單獨服用白蛋白結合型紫杉醇的患者中只有 14% 存活。

Importantly, the women who received Relacorilant and plus Nab-paclitaxel experienced no additional side effect burden compared to those who received Nab-paclitaxel alone, we expect roselle to replicate these results.

重要的是，與單獨接受白蛋白結合型紫杉醇治療的女性相比，接受 Relacorilant 聯合白蛋白結合型紫杉醇治療的女性沒有經歷額外的副作用負擔，我們預計洛神花能夠複製這些結果。

Enrollment in rosella is complete, we anticipate having enough progression events to analyze the study's primary endpoint progression free survival by the end of this year. We are conducting rosella in collaboration with leading clinicians from the Gynecologic oncology group or GOG in the United States and the European Network of Gynecological oncology trials or ENGOT group in Europe and deeply appreciate their enthusiasm and support.

rosella 的入組工作已完成，我們預計到今年年底將有足夠的進展事件來分析研究的主要終點無惡化存活期。我們正在與來自美國婦科腫瘤學組或 GOG 以及歐洲婦科腫瘤學試驗網絡或歐洲 ENGOT 組的領先臨床醫生合作進行羅塞拉試驗，並深深感謝他們的熱情和支持。

In anticipation of a successful outcome, we have established a stand alone oncology division. So we can move swiftly after the conclusion of rosella to bring reliant to the women who can benefit from it. Positive results will also prompt us to explore reliant as a treatment for earlier stages of ovarian cancer and other solid tumors that express the glucocorticoid receptor.

為了取得成功的結果，我們建立了一個獨立的腫瘤科。因此，我們可以在羅塞拉結束後迅速採取行動，為可以從中受益的女性帶來依賴。正面的結果也將促使我們探索依賴療法治療早期卵巢癌和其他表達糖皮質激素受體的實體腫瘤。

In addition to exploring its potential to re-sensitize tumors to chemotherapy, we are evaluating cortisol modulations activity in two other mechanisms of action.

除了探索其使腫瘤對化療重新敏感的潛力之外，我們還在評估皮質醇在其他兩種作用機制中的調節活性。

In combination with androgen deprivation therapy and immunotherapy.

與雄性激素剝奪療法和免疫療法相結合。

Cortisol stimulation is thought to be a major reason why patients with prostate cancer treated with the widely prescribed androgen receptor antagonist enzalutamide eventually experience resurgent disease deprived of androgen stimulation. Their tumor switched to cortisol activity to stimulate growth.

皮質醇刺激被認為是使用廣泛使用的雄性激素受體拮抗劑恩雜魯胺治療的前列腺癌患者最終在失去雄性激素刺激後疾病復發的主要原因。他們的腫瘤轉變為皮質醇活性來刺激生長。

Leading academic researchers and clinicians hypothesize that cortisolism modulation can block this tumor escape route.

領先的學術研究人員和臨床醫生假設皮質醇調節可以阻止這種腫瘤逃脫途徑。

Our collaborators at the University of Chicago are currently enrolling a randomized placebo controlled phase two trial of Relacorilant plus enzalutamide in patients with early stage prostate cancer before these patients have had an initial prostatectomy.

我們在芝加哥大學的合作者目前正在招募一項 Relacorilant 加 enzalutamide 的隨機安慰劑對照二期試驗，用於治療早期前列腺癌患者，此前這些患者尚未接受初始前列腺切除術。

Another potential role of cortisol modulation is in combination with immunotherapy because cortisol suppresses the immune system. It may blunt the effectiveness of cancer therapies intended to stimulate the immune system, adding a cortisol modulator to immunotherapy such as checkpoint inhibitors may enhance their effectiveness following our phase one B trial in advanced adrenal cancer we are evaluating next steps to further understand the role of cortisol modulation in combination with immunotherapies in other tumor types and earlier stages of cancer.

皮質醇調節的另一個潛在作用是與免疫療法結合，因為皮質醇會抑制免疫系統。它可能會削弱旨在刺激免疫系統的癌症療法的有效性，在免疫療法中添加皮質醇調節劑（例如檢查點抑製劑）可能會在我們對晚期腎上腺癌進行一期B 期試驗後增強其有效性，我們正在評估後續步驟，以進一步了解其作用皮質醇調節與其他腫瘤類型和癌症早期階段的免疫療法相結合。

Our research team has developed a library of more than 1,000 selective cortisol modulators with distinct pharmacodynamic properties. Some are more potent in modulating cortisol activity across many tissue types. Some are tissue specific, some are very potent in oncologic models, some less so some cross the blood brain barrier, some don't.

我們的研究團隊開發了一個包含 1,000 多種具有獨特藥效特性的選擇性皮質醇調節劑的庫。有些在調節多種組織類型的皮質醇活性方面更有效。有些是組織特異性的，有些在腫瘤模型中非常有效，有些則不太有效，有些可以穿過血腦屏障，有些則不能。

One of the compounds our scientists have created that is highly effective at getting into the brain is Dazucorilant. We have advanced Dazucorilant into clinical studies based on compelling data showing improved motor performance and reduced neuroinflammation and muscular atrophy in a commonly used mouse model of ALS. A randomized double blind placebo controlled phase two Dazu trial is ongoing at clinical sites in Europe, the United States and Canada.

我們的科學家發明的一種能夠非常有效地進入大腦的化合物是 Dazucorilant。我們已將 Dazucorilant 推進臨床研究，基於令人信服的數據顯示，在常用的 ALS 小鼠模型中，Dazucorilant 改善了運動性能並減少了神經發炎和肌肉萎縮。一項隨機雙盲安慰劑對照二期 Dazu 試驗正在歐洲、美國和加拿大的臨床中心進行。

249 patients with ALS have been randomized on a double blind basis to receive either 150 mg of Dazucorilant, 300 mg of Dazucorilant or placebo for 24 weeks. The primary endpoint is performance on the revised ALS functional rating scale score. A validated measure of the impact ALS has on patients. We expect to receive data by the end of the year.

249 名 ALS 患者在雙盲基礎上被隨機分配接受 150 mg Dazucorilant、300 mg Dazucorilant 或安慰劑治療，為期 24 週。主要終點是修訂後的 ALS 功能評定量表評分的表現。一項經過驗證的 ALS 對患者影響的衡量標準。我們預計在今年底前收到數據。

Mash metabolic dysfunction associated steatohepatitis is a serious liver disorder that afflicts millions of patients in the United States cortisol modulation may serve as an effective treatment for mash because cortisol activity has been implicated in both the initial development and progression of the disease.

馬什代謝功能障礙相關的脂肪性肝炎是一種嚴重的肝臟疾病，在美國困擾著數百萬患者。進展有關。

Our phase 1b dose finding study of miricorilant found that patients who receive 100 mg orally just twice a week for 12 weeks, experienced a 30% reduction in liver fat and improvements in liver enzymes, markers of fibrosis and key metabolic and lipid measures such as insulin resistance, serum triglycerides and LDL.

我們對miricorilant 進行的1b 期劑量發現研究發現，每週兩次口服100 毫克、持續12 週的患者，肝臟脂肪減少了30%，肝酵素、纖維化標記物以及胰島素等關鍵代謝和血脂指標均得到改善。

Importantly, miricorilant was also very well tolerated with none of the g side effects which commonly arise in patients being treated for MS A randomized double blind placebo controlled phase two. B. Monarch study aims to expand on these encouraging results. Monarch is enrolling two cohorts in the 1st 120 patients with biopsy confirmed MSH are randomized 2 to 1 to receive either 100 mg of miricorilant twice weekly or placebo for 48 weeks. The primary endpoint for this cohort is reduction in liver fat with biopsy-confirmed MASH resolution and fibrosis improvement. Key secondary end points.

重要的是，miricorilant 的耐受性也非常好，沒有任何副作用，而這種副作用通常發生在接受 MS 隨機雙盲安慰劑對照第二階段治療的患者中。B. Monarch 研究旨在擴展這些令人鼓舞的結果。Monarch 正在招募第一批 120 名活檢證實 MSH 的患者，以 2 比 1 的比例隨機分組，接受每週兩次 100 毫克的 miricorilant 或安慰劑，為期 48 週。該隊列的主要終點是肝臟脂肪的減少以及活檢證實的 MASH 分辨率和纖維化的改善。關鍵的次要終點。

The second cohort has a planned enrollment of 75 patients with presumed mesh patients in this cohort will be randomized 2 to 1 to receive either 100 mg of miricorilant twice weekly for six weeks, followed by 200 mg of miricorilant twice weekly for 18 weeks or placebo for the whole 24 weeks. In this cohort. The primary endpoint is also a reduction in liver fat.

第二個隊列計劃招募75 名患者，該隊列中的假定網狀患者將被隨機分為2 比1，接受100 毫克的miricorilant，每週兩次，持續6 週，然後接受200 mg 的miricorilant，每週兩次，持續18 週，或接受安慰劑，持續18 週。在這個隊列中。主要終點也是肝臟脂肪的減少。

This is an incredibly exciting time at Corcept, our commercial business is strong. The grace and gradient trial results demonstrate that we've developed a distinct superior treatment for patients with Cushing's syndrome.

在 Corcept，這是一個令人難以置信的激動人心的時刻，我們的商業業務非常強勁。寬限和梯度試驗結果表明，我們已經為庫欣氏症候群患者開發了一種獨特的優質治療方法。

The prevalence results from our CATALYST trial make it clear that there are far more patients with Cushing's syndrome than was previously assumed.

我們的 CATALYST 試驗的盛行率結果清楚地表明，庫欣氏症候群患者的數量比先前假設的要多得多。

But by the end of this year, we expect to receive treatment data from our CATALYST study in patients with Cushing's syndrome, as well as results from our pivotal rosella study in ovarian cancer. And our DAZAL study in ALS.

但到今年年底，我們預計將收到庫欣氏症候群患者 CATALYST 研究的治療數據，以及卵巢癌關鍵玫瑰疹研究的結果。還有我們針對 ALS 的 DAZAL 研究。

Positive results in these studies will be transformative for the company and more important lead to great benefit for the patients we serve. Every employee at Corcept understands the importance of the work we do. We are driven to support as quickly and as effectively as we can patients with Cushing's syndrome and the other disorders where cortisol modulation can make a difference.

這些研究的正面結果將為公司帶來變革，更重要的是為我們服務的患者帶來巨大利益。Corcept 的每位員工都了解我們所做工作的重要性。我們致力於盡快、有效地為庫欣氏症候群和其他皮質醇調節可以發揮作用的疾病患者提供支持。

Operator, Let's proceed now to questions.

接線員，我們現在開始提問。

Thank you. At this time, we'll conduct a question answer session as a reminder to ask a question.

謝謝。此時，我們將進行問答環節，以提醒提問。

(Operator Instructions)

（操作員說明）

David Amsellem, Piper Sandler.

大衛·阿姆塞勒姆，派珀·桑德勒。

Thanks. So just have a couple on the gradient data.

謝謝。所以只要有一些梯度資料就可以了。

First, I guess I'm I'm trying to better understand how to think about this. So you have on the blood pressure endpoint you active drug versus placebo. That difference was not statistically significant. I understand the differences versus baseline. But I guess my question here is, you know, how should one interpret that?

首先，我想我正在努力更好地理解如何思考這個問題。因此，在血壓終點上，您可以看到活性藥物與安慰劑的比較。這種差異沒有統計意義。我了解與基線的差異。但我想我的問題是，你知道，該如何解釋這一點？

Number one, just, just given the absence of separation specifically versus placebo, not baseline. And then number two, what gives you confidence that you will be able to not only file but be able to get approval here with the gradient data in hand given that that backdrop.

第一，只是考慮到與安慰劑相比沒有特別的分離，而不是基線。第二，是什麼讓您有信心，在這種背景下，您不僅能夠提交文件，而且能夠利用手中的梯度資料獲得批准。

And then I guess the last part of the question is that is gradient needed for approval. Has your communication with the FDA change regarding the role of gradient in the NBA?

然後我想問題的最後一部分是批准所需的梯度。關於梯度在 NBA 中的作用，您與 FDA 的溝通是否發生了變化？

Thank you, David. I think I understood all those questions. And first I, I'd just like to pass you over to Bill Guy, Bill is our Chief Development Officer. You've heard him on previous calls and I think he can answer your data question very specifically.

謝謝你，大衛。我想我理解了所有這些問題。首先，我想把您交給比爾蓋伊（Bill Guy），比爾是我們的首席開發長。您在之前的電話中聽過他的講話，我認為他可以非常具體地回答您的數據問題。

I think I can. Thank you, Dave for that question. I can hopefully address all your questions you've asked. So the most important thing to remember when you look at the gradient data is that as you pointed out, we're very confident with submitting an NDA based upon the gradient data, but it's not just the gradient data our NDA will include a total of four studies, our phase two study and three phase three studies grace as our pivotal study gradient as a supportive study.

我想我可以。謝謝戴夫提出這個問題。我希望能夠回答您提出的所有問題。因此，當您查看梯度資料時，要記住的最重要的一點是，正如您所指出的，我們非常有信心根據梯度資料提交 NDA，但這不僅僅是我們的 NDA 將包含的梯度資料四項研究，我們的第二階段研究和三個第三階段研究，作為我們的關鍵研究梯度作為支持性研究。

And another phase three study, we don't talk about as much, but I will today is study 452 which is our long term extension study altogether. This gives us the largest NDA package for Cushing's Syndrome and we have hundreds of patients. So going to the FDA with this large of a package, no other company has done that thus far.

另一個第三階段研究，我們不會談論太多，但我今天要討論的是研究 452，這是我們的長期擴展研究。這為我們提供了最大的庫欣氏症候群 NDA 方案，我們有數百名患者。因此，向 FDA 提交如此大的包裝，迄今為止還沒有其他公司這樣做過。

Now, gradient from its inception was always designed to be supportive of grace and Grace was always going to be our pivotal study. And that's our agreement with the FDA and we met our primary endpoint for grace.

現在，梯度從一開始就被設計為支持恩典，而恩典永遠是我們的關鍵研究。這是我們與 FDA 達成的協議，我們達到了寬限期的主要終點。

Now, as we look at the gradient trial, let me and even the grace trial or all of our trials together, let me remind you that Cushing's is a syndrome with many signs and symptoms, probably 20 or more signs and symptoms and hypertension and hyperglycemia are just two of those examples.

現在，當我們看梯度試驗時，讓我和恩典試驗或我們所有的試驗一起，讓我提醒您庫欣氏綜合症是一種具有許多體徵和症狀的綜合徵，可能有20 種或更多體徵和症狀以及高血壓和高血糖這只是其中兩個例子。

When you look at the results from gradient, it supports a successful path to an FDA because we see clinically significant improvements in all signs and symptoms of Cushing's Syndrome including improvements in blood pressure, blood glucose weight, just to name a few.

當您查看梯度結果時，它支持了FDA 的成功之路，因為我們看到庫欣氏症候群的所有體徵和症狀在臨床上都有顯著改善，包括血壓、血糖重量的改善，僅舉幾例。

Now, when it comes to blood pressure, in all of our studies, we see an immediate drop in blood pressure that starts at week two and continues out through week 22.

現在，說到血壓，在我們所有的研究中，我們發現血壓從第 2 週開始立即下降，一直持續到第 22 週。

In addition to that, as part of the syndrome, we see significant improvements in hyperglycemia. End points for fasting blood glucose, a glucose and hemoglobin A one C as Joe had mentioned. But also when we look at patients with even higher hemoglobin A one CS and have overt diabetes, we see an even greater response to all of those.

除此之外，作為此綜合症的一部分，我們發現高血糖有顯著改善。正如喬所提到的，空腹血糖、葡萄糖和血紅蛋白 A 和 C 的終點。但當我們觀察血紅素 A 1 CS 較高且患有明顯糖尿病的患者時，我們發現對所有這些的反應甚至更大。

And also when we look at all of the data, I'll tell you that Relacorilant produces a clinically significant and statistically significant improvement in insulin resistance because we see improvements in AUC insulin and HOMA-IR.

此外，當我們查看所有數據時，我會告訴您，Relacorilant 對胰島素阻抗產生了臨床顯著和統計顯著的改善，因為我們看到胰島素 AUC 和 HOMA-IR 有所改善。

As well as when we look at other factors like coagulation factors, we see statistical improvements in coagulation factors all favoring reliant as well as Joe mentioned, we saw significant improvement in body weight and body compositions. When we do Dexa scans, patients are losing fat from the visceral area, which is the bad fat in the belly area, which is what we wanted to see.

當我們觀察其他因素（如凝血因子）時，我們發現凝血因子的統計改善均有利於依賴，正如喬所提到的那樣，我們看到體重和身體組成顯著改善。當我們進行Dexa掃描時，患者內臟區域的脂肪正在減少，也就是腹部區域的壞脂肪，這正是我們希望看到的。

So altogether, this speaks to the broad improvement of Cushing's syndrome from the gradient study.

總而言之，這說明梯度研究對庫欣氏症候群的廣泛改善。

In addition to that, when you look at the safety profile, it confirms what we saw in grace as well as phase two. And it's consistent with the known safety profile of Relacorilant and no new safety signals were seen in the gradient trial. And I've got to reiterate because this is really important because it helps differentiate Relacorilant from any other product, especially that of corilant.

除此之外，當你查看安全概況時，它證實了我們在 Grace 以及第二階段中看到的情況。這與 Relacorilant 已知的安全性一致，並且在梯度試驗中沒有看到新的安全訊號。我必須重申，因為這非常重要，因為它有助於將 Relacorilant 與任何其他產品（尤其是 Corilant）區分開來。

We see no reported cases of endometrial hypertrophy with or without vaginal bleeding. No cases of adrenal insufficiency, no evidence of drug induced hypokalemia and no QT interval prolongation. All of this is supportive of and similar to that of what we saw in grace.

我們沒有看到子宮內膜肥大伴或不伴陰道出血的病例報告。沒有腎上腺功能不全的病例，沒有藥物引起的低血鉀的證據，也沒有QT間期延長。所有這些都支持並類似於我們在恩典中所看到的。

Now let me also come back to the other phase three study study 452 of why I feel confident with the positive FDA moving forward.

現在讓我也回到另一個第三階段研究 452，解釋為什麼我對 FDA 的積極進展充滿信心。

This study is a study that takes patients that come from our phase two trial and roll over or also come from grace gradient and roll into this trial. And so we will see patients who have remained on Reic Corant and some have been on this for over seven years. And we will be able to see data from this trial. People who were randomized placebo who now switch over to Relacorilant and will be able to evaluate their progression as well.

這項研究將我們第二階段試驗的患者轉入本試驗，或也來自恩典梯度的患者轉入本試驗。因此，我們會看到繼續服用 Reic Corant 的患者，有些患者已經服用了七年多。我們將能夠看到這次試驗的數據。接受隨機安慰劑治療的人現在改用 Relacorilant，也能夠評估他們的進展。

Now that the gradient study is unblinded, we can evaluate and look at this data and I will tell you that it's highly supportive of what we've seen in all of our studies because high potential response shows clinically significant and statistically significant improvements in both systolic and diastolic blood pressure at month six and it continues and continues to improve out two years.

現在梯度研究是非盲的，我們可以評估和查看這些數據，我會告訴您，它高度支持我們在所有研究中看到的結果，因為高潛在反應顯示收縮壓和統計顯著性改善和第六個月的舒張壓，並且在兩年內持續改善。

So when you look at the totality of evidence that we see from all of these studies, we believe we have a successful path to a positive FDA for relic Relacorilant that will happen in the coming weeks.

因此，當您查看我們從所有這些研究中看到的全部證據時，我們相信我們已經成功地獲得了 FDA 對 Relic Relacorilant 的積極認可，這將在未來幾週內發生。

Thank. Thank you, Bill.

感謝。謝謝你，比爾。

Next question please.

請下一個問題。

Matt Kaplan, Ladenburg.

馬特卡普蘭，拉登堡。

Hey, guys, can you hear me?

嘿，夥計們，你們聽得到我說話嗎？

Yeah, please speak up Matt a little bit. It's a little fuzzy.

是的，請馬特說一點。有點模糊。

I'll try out. Okay. So yeah, thanks for taking the question and, and thanks for clearing up the question on on gradient that was very helpful already. And then just with respect to the results you're seeing for coral and during the quarter, can you talk a little bit about if you're seeing an impact of the a CATALYST results, the initial results showing the the prevalence in terms of additional screenings that are going on to ID identify patients with, with with cushions.

我會嘗試一下。好的。所以，是的，感謝您提出這個問題，並且感謝您解決了有關梯度的問題，這已經非常有幫助了。然後，就您在本季度看到的珊瑚結果而言，您能否談談您是否看到了 CATALYST 結果的影響，初步結果顯示了額外的流行程度正在進行的身份識別篩檢可以識別出帶有墊子的患者。

Yes, Matt, thanks very much for the question. I understand that. And I think Sean Maduck, the President of our Endocrinology division is best prepared to answer that question. Go ahead, Sean.

是的，馬特，非常感謝你的提問。我明白這一點。我認為我們內分泌部門的總裁肖恩·馬杜克（Sean Maduck）最有可能回答這個問題。繼續吧，肖恩。

Thanks for the question. And yeah, I mean the short answer is yes, we are starting to see some impact from, from CATALYST and those results. I will say though that it takes some time for those results to roll into guidelines and sort of practices and it's going to take some time to see the full effect, so our expectation is that we will see the full effect later into 2025 and beyond.

謝謝你的提問。是的，我的意思是簡短的答案是肯定的，我們開始看到來自 CATALYST 和這些結果的一些影響。我想說的是，這些結果需要一些時間才能納入指導方針和實踐，並且需要一些時間才能看到全面的效果，因此我們的期望是，我們將在2025 年晚些時候及以後看到全面的效果。

What I wanted to touch on though is that we have seen tremendous volume growth in 2024. And obviously, that CATALYST was part of it, but I wanted to touch on specifically why we're really just getting started.

不過，我想談談的是，我們在 2024 年看到了銷量的巨大成長。顯然，催化劑是其中的一部分，但我想具體談談為什麼我們才剛開始。

And at the front of the curve of that growth, one Joe mentioned it in his early comments and that's that hypercortisol hypercortisolism is once is more prevalent than one's thought and it's no longer considered, considered an ultra rare disease. There's been multiple studies in the last couple of years that have highlighted this fact, CATALYST enforced it with the one in four number. And even the most recent FDA guidance in 2023 highlighted that the number is bigger. So there's far more prevalence.

在這種成長曲線的前端，喬在他的早期評論中提到了這一點，那就是皮質醇增多症曾經比人們想像的更普遍，並且不再被認為是一種極其罕見的疾病。過去幾年的多項研究都強調了這一事實，CATALYST 以四分之一的比例強制執行了這一事實。甚至 FDA 2023 年最新指南也強調這一數字更大。所以流行率高很多。

Because of that prevalence we're seeing more and more screening across multiple different physician groups, they're looking for these patients, they're finding them and the paradigm is shifting.

由於這種普遍性，我們看到越來越多的針對多個不同醫生群體的篩檢，他們正在尋找這些患者，他們正在尋找他們，範式正在改變。

But again, we're just at the beginning of that shift and we're confident that over time, this screening is going to become routine behavior. So with the increased recognition that this is more prevalent and the increase screening, we expect volume growth to be substantial in the near term. And in the long term, I mean quorum is a great product, but Relacorilant is going to be even better.

但同樣，我們正處於這一轉變的開始，我們相信隨著時間的推移，這種篩檢將成為常規行為。因此，隨著人們越來越認識到這種現象更加普遍，且篩檢量不斷增加，我們預計近期銷量將大幅成長。從長遠來看，我的意思是 quorum 是一個很棒的產品，但 Relacorilant 會更好。

It shows efficacy across multiple and all signs and symptoms of Cushing's syndrome as Bill just walked through and Joe walked through in his comments and it has a significant safety benefit. It doesn't have the off target, just our own effects that we see with quorum. It does not cause hypokalemia. It does not cause adrenal insufficiency and it does not, does not cause QT prolongation which really separates it from all the other products in the market.

它顯示了對庫欣氏症候群的多種和所有體徵和症狀的功效，因為比爾剛剛走過，喬在他的評論中走過，並且它具有顯著的安全益處。它沒有偏離目標，只是我們在法定人數中看到的我們自己的影響。它不會引起低血鉀症。它不會導致腎上腺功能不全，也不會導致 QT 延長，這確實將其與市場上的所有其他產品區分開來。

So, you know, because of this fact and because of where we see this growth going, we believe we're on a track to be a $3 billion business in the next five years.

因此，您知道，由於這一事實以及我們看到的成長趨勢，我們相信我們有望在未來五年內成為價值 30 億美元的企業。

Thank you, Sean. And thank you. Next question, please.

謝謝你，肖恩。謝謝你。請下一個問題。

Ramakanth, H.C. Wainwright.

拉馬坎特，H.C.溫賴特。

Thank you. This is. RK from H.C. Wainwright. A quick question on the Rosella study. So in the prepared remarks, Joe, you're stating that you expect they, they that you will have all the events that you need for analysis by the end of the year.

謝謝。這是。RK 來自 H.C.溫賴特。關於羅塞拉研究的一個簡單問題。因此，喬，在準備好的發言中，您表示您期望他們，他們將在今年年底之前獲得分析所需的所有事件。

So my question is, would you have enough time, you know, to even do the analysis and release the data or do you think you will just get to the point of having enough events by the end of the year?

所以我的問題是，你是否有足夠的時間來進行分析並發布數據，或者你認為你會在年底之前舉辦足夠的活動嗎？

I'm going to pass you back to Bill for a second. But let me just answer your question generally as opposed to other studies where for instance, you have a 20 week, 24 week study with a double blind period and you break the blind and you have the results oncology studies are a little bit less determined because you're waiting for a number of events to occur and you do your best calculation.

我將把您轉回給比爾。但讓我籠統地回答你的問題，而不是其他研究，例如，你有一個為期20 週、24 週的雙盲期研究，你打破了盲法，你得到的結果是腫瘤學研究的確定性稍差一些，因為你正在等待許多事件的發生，然後你會做出最好的計算。

And of course, we have done that. Now, I'll give you back the bill to give you kind of specifics but understand that that lack of specificity in the and when a result will read out from an oncology study is just par for the course for oncology studies. But bill, please go ahead. Yes.

當然，我們已經做到了。現在，我將把賬單退還給您，為您提供一些具體信息，但請理解，腫瘤學研究中缺乏具體性以及何時讀出結果只是腫瘤學研究課程的標準。但是比爾，請繼續。是的。

So I'll add a little bit more color, but I completely agree with that.

所以我會添加更多的顏色，但我完全同意這一點。

So, you know, when you look at Relacorilant plus Nab-paclitaxel, a key thing that differentiates it probably from any other drug or combination in a platin resistant ovarian cancer is that we see a differential effect on duration of response. And that duration of response is what's driving the PFS and OS benefit that we saw in phase two.

所以，您知道，當您考慮 Relacorilant 聯合白蛋白結合型紫杉醇時，它與鉑類抗藥性卵巢癌的任何其他藥物或組合的一個關鍵區別在於，我們看到了對反應持續時間的不同影響。反應持續時間推動了我們在第二階段看到的 PFS 和 OS 優勢。

So if you model that out where we saw the greatest benefit in the phase two trial is women who were living longer, especially two times the amount of women who are living longer at year two for Relacorilant plus Nab-paclitaxel versus Nab-paclitaxel alone.

因此，如果您進行建模，我們發現第二階段試驗中最大的益處是壽命較長的女性，尤其是第二年使用Relacorilant 聯合白蛋白結合型紫杉醇與單獨使用白蛋白結合型紫杉醇相比，壽命較長的女性數量的兩倍。

Now, we're replicating that in a study that is 2 to 3 times larger. And so it does just come down to the number of women that are progressing. Now, we hope the longer this goes this shows that women are living even longer on relient plus Napack Taxel. But once we cross that number of events, my team and I are prepared to analyze that data and announce it as soon as possible.

現在，我們正在一項規模擴大 2 到 3 倍的研究中複製這一點。因此，這確實取決於正在進步的女性數量。現在，我們希望這種情況持續的時間越長，這表示女性服用 relient 加上 Napack Taxel 的壽命更長。但是，一旦我們完成了這麼多的事件，我和我的團隊就準備好分析這些數據並儘快公佈。

And we're on track to see that, you know, cross that endpoint by the end of the year and analyze that data as soon as we can to then talk about it publicly and present it at a conference next year.

我們預計在今年年底之前跨越該終點，並儘快分析這些數據，然後公開討論並在明年的會議上展示它。

But we will release that information as soon as our analysis are done on arcade is obviously very important event. We'll, you'll hear about it. We just can't tell you what day it's going to be yet.

但是，一旦我們對街機進行了分析，我們就會立即發布該訊息，這顯然是非常重要的事件。我們會的，你會聽到的。我們只是還不能告訴你具體是哪一天。

Thank you. Thanks for the call.

謝謝。感謝您的來電。

Okay, sure. Next question please.

好吧，當然。請下一個問題。

Joon Lee.

俊李.

Hey, thanks for taking our questions. Your characterization of gradient is seems to be as a supportive study while Grace is the pivotal is that view shared by the FDA?

嘿，感謝您回答我們的問題。你對梯度的描述似乎是一項支持性研究，而 Grace 是關鍵，FDA 也同意這個觀點嗎？

Yes. And, and, and I'd like to pass you over to Charlie Rob, who handles all of our regulatory affairs and I think can really provide some very useful color to you.

是的。而且，而且，我想把您交給查理·羅布（Charlie Rob），他負責處理我們所有的監管事務，我認為他確實可以為您提供一些非常有用的信息。

Yeah. Hi June. The answer is yes. And you know, I think, you know, one thing I know, I'm sure you understand, but maybe not all of our listeners do is that, you know, this isn't some, you know, a dark art where we have to guess what's on the FDA'S mind. I mean, there's published guidance as well as, you know, any conversations a sponsor may have where the FDA has made it clear that a single well controlled study which we have in the form of our grace and the data from grace, along with confirmatory evidence is sufficient to demonstrate a drug safety and efficacy.

是的。嗨，六月。答案是肯定的。你知道，我想，你知道，我知道一件事，我相信你明白，但也許不是我們所有的聽眾都知道，你知道，這不是一種我們可以用它來表達的黑暗藝術。的想法。我的意思是，有已發布的指南，以及申辦者可能進行的任何對話，其中FDA 已明確表示，我們以我們的恩典和來自恩典的數據的形式進行了一項良好對照的研究，以及驗證性的研究證據足以證明藥物的安全性和有效性。

And, you know, Bill gave you really the strong clinical view. But I just wanted to underscore, you know, from the perspective of the person who has to go in with the team and present the arguments to the FDA. Just what a good position we're in. I mean, we've studied as Bill pointed out Relacorilant and more patients with Cushing's Syndrome than any other company with approved treatments out there. So we have a tremendous amount of data.

而且，你知道，比爾給了你真正強而有力的臨床觀點。但我只是想強調，你知道，從必須與團隊一起向 FDA 提出論點的人的角度來看。我們處於多麼好的位置。我的意思是，正如 Bill 指出的那樣，我們進行了研究，Relacorilant 的庫欣氏症候群患者數量比任何其他擁有批准治療方法的公司都多。所以我們有大量的數據。

And our findings have been remarkably consistent from phase two to grace to our extension study. And now to gradient patients who receive Rli Corant got better across the entire range of Cushing's syndrome size and symptoms. It's really as simple as that. It's that easy an argument to prevent, to present to the FDA.

從第二階段到擴展研究，我們的研究結果非常一致。現在，接受 Rli Corant 治療的梯度患者在庫欣氏症候群的大小和症狀的整個範圍內都得到了改善。真的就是這麼簡單。向 FDA 提出這樣的爭論是很容易預防的。

Got it. And when was the last interaction with the FDA? And have you already have a pre FDA a meeting with the FDA? Seems like you're planning to submit the FDA within weeks. So just curious if you've already had that conversation with the (inaudible).

知道了。上次與 FDA 互動是什麼時候？您是否已經與 FDA 召開了 FDA 前會議？看來您計劃在幾週內向 FDA 提交申請。所以只是好奇你是否已經與（聽不清楚）。

Well, so I mean, you'll appreciate we, we don't comment on the, you know, the particulars or interactions with the FDA. But I mean, I can say that we've talked to the FDA plenty about this program about all of our programs and I foresee absolutely no impediments to getting our, our FDA in.

好吧，所以我的意思是，您會感激我們，我們不會對細節或與 FDA 的互動發表評論。但我的意思是，我可以說，我們已經與 FDA 就該計劃以及我們所有的計劃進行了大量討論，我預計我們的 FDA 參與絕對不會遇到任何障礙。

Got it. And one more, please. Did the hyperglycemia end point separate from the placebo? I just wanted to clarify if that was, please.

知道了。請再來一張。高血糖終點是否與安慰劑不同？我只是想澄清一下是否是這樣。

The answer is yes. But Bill, let me just repeat the question that June said. Did the patients who were treated with reliant on the hyperglycemia endpoints separate from those who were treated with placebo?

答案是肯定的。但是比爾，讓我重複瓊所說的問題。依賴高血糖終點進行治療的患者與接受安慰劑治療的患者是否有所不同？

Yes, they were all statistically significantly different favoring Relacorilant for all hyperglycemia end points and those endpoints got better even as we got higher A1c. So we hit it for all patients and we hit it also for patients who were sicker with overt diabetes.

是的，在所有高血糖終點上，它們在統計上都顯著不同，有利於 Relacorilant，而且即使我們的 A1c 較高，這些終點也會變得更好。因此，我們為所有患者提供了治療方案，也為患有明顯糖尿病的病情較重的患者提供了治療方案。

All looking forward to the full day of next year. Thank you.

所有人都期待明年的充實一天。謝謝。

Okay, thank you June. Well, thank you everybody for tuning in. I'll just repeat. This is for all those who followed us for a long time. There's been no more exciting time at Corcept. This is when things are really starting to happen and we really have an opportunity to help a much larger group of patients than we previously helped.

好的，謝謝你，六月。嗯，謝謝大家的收聽。我就重複一遍。這是獻給所有長期關注我們的人的。Corcept 沒有比這更令人興奮的時刻了。這是事情真正開始發生的時候，我們確實有機會幫助比我們以前幫助的更多的患者。

So we're, we're really very, very excited about this and look forward to sharing the next results for you and talking to you to you next quarter. Thank you.

因此，我們對此感到非常非常興奮，並期待與您分享下一個結果，並在下個季度與您交談。謝謝。

Thank you. This concludes the question answer session. Thank you for your participation in today's conference. This concludes the program. You may now disconnect.

謝謝。問答環節到此結束。感謝您參加今天的會議。程式到此結束。您現在可以斷開連線。