Celcuity Inc (CELC) 2025 Q2 法說會逐字稿

Good afternoon, ladies and gentlemen, and welcome to the Celcuity second-quarter 2025 financial results webcast and conference call. (Operator Instructions) I would now like to turn the conference over to Apoorva Chaloori with ICR Healthcare. Please go ahead.

女士們、先生們，下午好，歡迎參加 Celcuity 2025 年第二季財務業績網路廣播和電話會議。（操作員指示）現在，我想將會議交給 ICR Healthcare 的 Apoorva Chaloori。請繼續。

Thank you, operator, and good afternoon to everyone. Thank you for joining us to review Celcuity's second-quarter 2025 financial results and business update. Earlier today, Celcuity Inc., released financial results for the second quarter ended June 30, 2025. The press release can be found on the Investor section of Celcuity's website.

謝謝接線員，大家下午好。感謝您與我們一起回顧 Celcuity 2025 年第二季的財務表現和業務更新。今天早些時候，Celcuity Inc. 發布了截至 2025 年 6 月 30 日的第二季財務業績。新聞稿可在 Celcuity 網站的投資者部分找到。

Joining me on the call today are Brian Sullivan, Celcuity's Chief Executive Officer and Co-Founder; Vicky Hahne, Chief Financial Officer; as well as Igor Gorbachevsky, Chief Medical Officer, who will be available during Q&A.

今天參加電話會議的還有 Celcuity 執行長兼聯合創始人 Brian Sullivan、財務長 Vicky Hahne 以及首席醫療官 Igor Gorbachevsky，他將在問答環節出席。

Before we begin, I would like to remind listeners that our comments today will include some forward-looking statements. These statements involve a number of risks and uncertainties which are outlined in today's press release and in our reports and filings with the SEC. Actual events or results may differ materially from those projected in the forward-looking statements.

在我們開始之前，我想提醒聽眾，我們今天的評論將包括一些前瞻性的陳述。這些聲明涉及許多風險和不確定性，這些風險和不確定性已在今天的新聞稿以及我們向美國證券交易委員會提交的報告和文件中概述。實際事件或結果可能與前瞻性陳述中的預測有重大差異。

Such forward-looking statements and their implications involve known and unknown risks, uncertainties, and other factors that may cause actual results or performance to differ materially from those projected.

此類前瞻性陳述及其意義涉及已知和未知的風險、不確定性和其他因素，可能導致實際結果或績效與預測有重大差異。

On this call, we will also refer to non-GAAP financial measures. These non-GAAP measures are used by management to make strategic decisions, forecast future results, and evaluate the company's current performance.

在本次電話會議上，我們也將參考非公認會計準則財務指標。管理階層使用這些非公認會計準則指標來制定策略決策、預測未來結果並評估公司的當前績效。

Management believes the presentation of these non-GAAP financial measures is useful for investors' understanding and assessment of the company's ongoing core operations and prospects for the future. You can find the table reconciling the non-GAAP financial measures to GAAP measures in today's press release.

管理階層認為，這些非公認會計準則財務指標的呈現有助於投資者了解和評估公司正在進行的核心業務和未來前景。您可以在今天的新聞稿中找到非 GAAP 財務指標與 GAAP 指標的對照表。

And with that, I would now like to turn the call over to Brian Sullivan, CEO of Celcuity. Please go ahead.

現在，我想將電話轉給 Celcuity 執行長 Brian Sullivan。請繼續。

Thank you, Apoorva, and good afternoon, everyone. Thank you for joining our second-quarter financial results conference call. The past few months have been eventful ones for Celcuity. We achieved several significant milestones, and we believe these milestones lay the foundation for us to potentially establish gedatolisib as a new standard of care therapy for patients with HR-positive, HER2-negative advanced breast cancer.

謝謝你，Apoorva，大家下午好。感謝您參加我們的第二季財務業績電話會議。過去幾個月對 Celcuity 來說是多事之秋。我們取得了幾個重要的里程碑，我們相信這些里程碑為我們有可能將 gedatolisib 確立為 HR 陽性、HER2 陰性晚期乳癌患者的新標準治療奠定了基礎。

First and most importantly, of course, was the positive top-line data we've reported from the PIK3CA wild-type cohort of our Phase 3 VIKTORIA-1 clinical trial. In patients with HR-positive, HER2-negative, PIK3CA wild-type, advanced breast cancer, gedatolisib plus fulvestrant and palbociclib or the gedatolisib triplet, and gedatolisib plus fulvestrant, or the gedatolisib doublet, met the study's two primary endpoints by demonstrating statistically significant and clinically meaningful improvement in progression-free survival, or PFS, versus fulvestrant.

首先也是最重要的，當然是我們從 3 期 VIKTORIA-1 臨床試驗的 PIK3CA 野生型隊列中報告的積極的頂線數據。對於 HR 陽性、HER2 陰性、PIK3CA 野生型晚期乳癌患者，gedatolisib 加氟維特

The reported hazard ratios and improvements in median PFS are unprecedented in HR-positive, HER2-negative advanced breast cancer. We believe these data validate our hypothesis that the role of the PIK3CA, or PI3K, AKT, mTOR, or PAM pathway as a cancer driver is not solely a function of the presence of a pathway mutation.

報告的風險比和中位 PFS 改善在 HR 陽性、HER2 陰性晚期乳癌中是前所未有的。我們相信這些數據驗證了我們的假設，即 PIK3CA 或 PI3K、AKT、mTOR 或 PAM 通路作為癌症驅動因素的作用不僅僅是通路突變的存在的功能。

And the implications are profound for patients with HR-positive, HER2-negative advanced breast cancer as we seek to advance gedatolisib as a therapeutic option for patients with or without PIK3CA mutations in both the second-line and first-line settings.

當我們尋求將 gedatolisib 推進為二線和一線治療中患有或不患有 PIK3CA 突變的患者的治療選擇時，這對於 HR 陽性、HER2 陰性晚期乳癌患者俱有深遠的影響。

Second important milestone achieved was the dosing of the first patient in our Phase 3 VIKTORIA-2 clinical trial. And this trial is evaluating gedatolisib in combination with a CDK4-6 inhibitor and fulvestrant as first-line treatment for patients with HR-positive, HER2-negative advanced breast cancer.

實現的第二個重要里程碑是我們第三階段 VIKTORIA-2 臨床試驗的第一位患者接受給藥。該試驗正在評估 gedatolisib 與 CDK4-6 抑制劑和氟維司群聯合作為 HR 陽性、HER2 陰性晚期乳癌患者的第一線治療。

The third milestone was the announcement of favorable preliminary top-line results from two early-phase clinical trials. One, evaluating gedatolisib and darolutamide in men with metastatic, castration-resistant prostate cancer, and a second one that evaluated gedatolisib and atrastuzumab biosimilar in patients with HER2-positive PIK3CA-mutated metastatic breast cancer.

第三個里程碑是宣布兩項早期臨床試驗的初步結果良好。一項研究評估了格達托利西布和達洛魯胺對轉移性去勢抵抗性前列腺癌患者的療效，另一項研究評估了格達托利西布和阿曲妥珠單抗生物仿製藥對 HER2 陽性 PIK3CA 突變轉移性乳腺癌患者的療效。

Fourth milestone was the extension of our patent exclusivity for gedatolisib into 2042 with the issuance of a new dosing regimen patent for gedatolisib.

第四個里程碑是，我們將 gedatolisib 的專利獨佔期延長至 2042 年，並頒發了 gedatolisib 的新給藥方案專利。

And finally, we raised around $287 million to public offerings of convertible notes, common stock, and pre-funded warrants that provide the funding that should allow us to aggressively prepare for our launch of gedatolisib should we get FDA approval next year.

最後，我們透過公開發行可轉換票據、普通股和預先出資的認股權證籌集了約 2.87 億美元，這些資金將使我們能夠積極準備推出 gedatolisib（如果我們明年獲得 FDA 批准）。

I'd like now to turn to the VIKTORIA-1 trial. Last month, we announced top-line results from this trial. Median progression-free survival, or PFS, for the gedatolisib was tripled. It was 9.3 months compared to only two months for fulvestrant, 7.3 months incremental improvement in median PFS.

現在我想談談 VIKTORIA-1 試驗。上個月，我們公佈了此次試驗的最終結果。gedatolisib 的中位無惡化存活期（PFS）增加了兩倍。與氟維司群僅 2 個月相比，該組 PFS 中位數為 9.3 個月，增量提高了 7.3 個月。

The hazard ratio was 0.24, which translates to 4.2 times higher likelihood of survival without disease progression for the gedatolisib triplet than fulvestrant. For the gedatolisib doublet, median PFS was 7.4 months, again, compared to only two months for fulvestrant, 5.4 months incremental improvement in median PFS. The hazard ratio was 0.33, which translates to 3 times higher likelihood of survival without disease progression for the gedatolisib doublet than fulvestrant.

風險比為 0.24，這意味著格達托利西布三聯療法無疾病進展生存的可能性比氟維司群高 4.2 倍。對於 gedatolisib 雙藥，中位 PFS 為 7.4 個月，而氟維司群僅為 2 個月，中位 PFS 增量改善了 5.4 個月。風險比為 0.33，這意味著格達托利西布雙藥組無疾病進展生存的可能性比氟維司群組高 3 倍。

Now, these results established several new milestones in the history of drug development for this patient population. First, the hazard ratios reported for both the geda triplet and doublet were the most favorable ever reported by any Phase 3 trial, first line, second line, or third line in this population.

現在，這些結果為該患者群體的藥物開發歷史樹立了幾個新的里程碑。首先，Geda 三聯療法和雙聯療法報告的風險比是該族群中任何 3 期試驗（第一線、二線或三線療法）所報告的最有利的。

And second, the incremental improvements in median PFS for the triplet and doublet, 7.3 and 5.4 months, respectively, were the highest ever reported by any Phase 3 trial for this patient population, receiving at least their second line of therapy for advanced disease.

其次，三聯療法和雙聯療法的中位 PFS 分別增加了 7.3 個月和 5.4 個月，這是針對該患者群體進行的任何 3 期試驗中報告的最高值，這些患者至少接受了針對晚期疾病的第二線治療。

And third, gedatolisib is the first PAM inhibitor to achieve a positive Phase 3 data result in patients with PIK3CA wild-type tumors and whose disease progressed on or after treatment with the CDK4-6 inhibitor. And for comparison purposes, it's important to note that several Phase 3 studies in this patient population have reported data recently.

第三，gedatolisib 是第一個在 PIK3CA 野生型腫瘤患者中取得積極的 3 期數據結果的 PAM 抑制劑，並且在使用 CDK4-6 抑制劑治療期間或之後病情出現進展。為了進行比較，值得注意的是，針對該患者群體的幾項 3 期研究最近已報告了數據。

In these studies, the incremental improvement in median PFS ranged from 1.7 to 3.9 months, and the hazard ratios ranged from 0.55 to 0.73. Both gedatolisib regimens exhibited a favorable safety profile, including lower rates of hyperglycemia and somatitis, and the rate of discontinuation of all treatment due to a treatment-related adverse event was lower than was reported in a Phase 1b study in this patient population.

在這些研究中，中位數PFS的增量改善範圍為1.7至3.9個月，風險比範圍為0.55至0.73。兩種Gedatolisib方案均表現出良好的安全性，包括較低的高血糖和軀體炎發生率，並且由於治療相關不良事件而停止所有治療的比例低於該患者群體的1b期研究報告的比例。

In light of the favorable safety profile, more favorable hazard ratios, and longer incremental PFS with the gedatolisib regimens than the other currently available or investigational agents, we believe both the gedatolisib triplet and doublet each have the potential to establish a new standard of care for these patients.

鑑於 gedatolisib 方案比其他目前可用或研究藥物具有良好的安全性、更有利的風險比和更長的增量 PFS，我們相信 gedatolisib 三聯療法和雙聯療法都有可能為這些患者建立新的護理標準。

We're on track to submit a new drug application to the FDA in the fourth quarter of 2025 for geda based on data from the PIK3CA wild-type cohort. And we're looking forward to presenting the full data set later this year at an upcoming medical conference. Additionally, we expect to release top-line data for the VIKTORIA-1 PIK3CA mutation cohort by the end of 2025.

我們計劃於 2025 年第四季根據 PIK3CA 野生型隊列的數據向 FDA 提交 geda 的新藥申請。我們期待在今年稍後即將召開的醫學會議上展示完整的數據集。此外，我們預計將在 2025 年底發布 VIKTORIA-1 PIK3CA 突變隊列的頂線數據。

Moving on, I want to share just a quick overview of the market landscape we see for gedatolisib and how we're gearing up for a potential launch should we get FDA approval. We think the market looks very promising for gedatolisib. We estimate there are 34,000 patients moving to second-line treatment after progressing on a CDK4-6 inhibitor, and roughly 60% of them are PIK3CA wild-type. That's a very large opportunity.

接下來，我想簡單介紹一下我們所看到的 gedatolisib 的市場格局，以及如果獲得 FDA 批准，我們將如何為潛在的上市做準備。我們認為 gedatolisib 的市場前景非常廣闊。我們估計有 34,000 名患者在服用 CDK4-6 抑制劑後病情出現進展，轉入第二線治療，其中約 60% 為 PIK3CA 野生型。這是一個非常大的機會。

And there's also a significant need for more efficacious therapies than those currently available. Currently, approved therapies only offer two to four months of median PFS. With gedatolisib's unique mechanism of action, corresponding clinical benefit, it's all positioned to address critical needs in the second-line space.

此外，我們還需要比目前更有效的治療方法。目前，核准的療法僅能提供兩到四個月的平均 PFS。gedatolisib 具有獨特的作用機制和相應的臨床益處，可滿足二線領域的關鍵需求。

And this unmet need has been verified in our market research, which shows that oncologists are hungry for options that are more effective and have a safety profile they can manage. And as we've discussed on prior calls, efficacy and safety are the two primary criteria oncologists use to select therapies for their patients. This is also consistent with the criteria used by treatment guidelines, such as NCCN, to determine recommendation categories for drug treatments.

我們的市場研究已經證實了這個未滿足的需求，研究表明腫瘤學家渴望獲得更有效且具有他們可以管理的安全性的選擇。正如我們在先前的電話會議中討論過的，療效和安全性是腫瘤學家為患者選擇治療方法的兩個主要標準。這也與NCCN等治療指引確定藥物治療建議類別的標準一致。

Additionally, as an IV-administered therapy, we believe gedatolisib will be very well received in the community practice setting, where over 80% of patients are treated. Gedatolisib will fall under the medical benefit category, which means typically a smoother reimbursement process compared to oral drugs that fall under the pharmacy benefit category. For oral drugs, payers tend to manage claims more heavily, resulting in a more cumbersome prescribing and reimbursement process for practices.

此外，作為一種靜脈注射療法，我們相信 gedatolisib 將在社區實踐環境中受到廣泛歡迎，超過 80% 的患者在社區實踐環境中接受治療。Gedatolisib 將屬於醫療福利類別，這意味著與屬於藥房福利類別的口服藥物相比，其報銷流程通常更為順暢。對於口服藥物，付款人傾向於更嚴格地管理索賠，導致診所的處方和報銷流程更加繁瑣。

And unlike oral drugs, IV-administered therapies also allow physicians to recover costs associated with the purchase and administration of therapy, and to better ensure patient compliance with the treatment regimen. And finally, the breast cancer community is active, engaged, and well-supported by advocacy groups, which will help create awareness for new treatments in general, and we think for gedatolisib, specifically.

與口服藥物不同，靜脈注射療法也能讓醫師收回購買和管理療法的相關成本，並更確保患者遵守治療方案。最後，乳癌社群非常活躍，積極參與，並得到倡導團體的大力支持，這將有助於提高人們對新療法的認識，特別是對 gedatolisib 的認識。

As a result, we believe Celcuity has the opportunity to build a strong presence amongst medical oncologists to address this large, underserved patient population. And based on our projections, we believe the addressable market potential for a standard of care second-line therapy to treat this patient population is roughly $5 billion.

因此，我們相信 Celcuity 有機會在腫瘤醫學專家中建立強大的影響力，以解決這個龐大且服務不足的患者群體的問題。根據我們的預測，我們認為用於治療該患者群體的標準二線治療的潛在市場潛力約為 50 億美元。

I'd like now to turn to our Phase 3 VIKTORIA-2 trial. Last month, we announced that we dosed the first patient in VIKTORIA-2 that's evaluating gedatolisib plus a CDK4-6 inhibitor that the investigator may choose, and fulvestrant as first-line treatment for patients who have endocrine therapy-resistant HR-positive, HER2-negative advanced breast cancer.

現在我想談談我們的第三階段 VIKTORIA-2 試驗。上個月，我們宣布對 VIKTORIA-2 中的第一位患者進行了給藥，該研究正在評估 gedatolisib 加上研究者可以選擇的 CDK4-6 抑製劑以及氟維司群作為對內分泌治療耐藥的 HR 陽性、HER2 陰性晚期乳腺癌患者的一線治療。

The standard of care first-line treatment for most endocrine therapy-resistant patients includes any one of three approved CDK4-6 inhibitors combined with fulvestrant. And results from a recent trial suggest the median progression-free survival period for patients receiving one of these three regimens is only about seven to eight months and highlighting the significant need for more efficacious frontline therapy for these patients. We believe the positive top-line data from the PIK3CA wild-type cohort of our VIKTORIA-1 study are as well for the gedatolisib triplet in this patient population.

對於大多數內分泌治療抗性的患者，第一線治療的標準包括三種核准的 CDK4-6 抑制劑中的任意一種與氟維司群聯合使用。最近一項試驗的結果表明，接受這三種方案之一的患者的中位無惡化存活期僅為七到八個月左右，凸顯了這些患者對更有效的一線治療的迫切需求。我們相信，VIKTORIA-1 研究的 PIK3CA 野生型隊列的積極頂線數據也適用於該患者群體中的 gedatolisib 三聯體。

I'd like now to turn to our Phase 1b/2 clinical trial that's evaluating gedatolisib in combination with darolutamide in men with metastatic, castration-resistant prostate cancer. In late June, we announced encouraging Phase 1b preliminary efficacy and safety data from the study, which enrolled 38 prostate cancer patients who were randomly assigned to either receive 80 milligrams of darolutamide twice daily, combined with either 120 milligrams of gedatolisib in Arm 1 or 180 milligrams of gedatolisib in Arm 2. And gedatolisib was administered once weekly for three weeks and then one week off in both arms.

現在我想談談我們的 1b/2 期臨床試驗，該試驗正在評估格達托利西布與達洛魯胺聯合治療轉移性去勢抵抗性前列腺癌男性的效果。6 月底，我們公佈了令人鼓舞的 1b 期初步療效和安全性數據，該研究招募了 38 名前列腺癌患者，他們被隨機分配接受每天兩次 80 毫克達洛魯胺，聯合 120 毫克格達托利西布（第 1 組）或 180 毫克格達托利西布（第 2 組）。兩組每週服用一次 gedatolisib，連續服用三週，然後停藥一週。

The preliminary analyses for the combined arms show the six-month radiographic PFS rate was 66%, which compares favorably to published data for androgen receptor inhibitors in this setting.

聯合治療組的初步分析顯示，六個月的放射學 PFS 率為 66%，與該環境下雄激素受體抑制劑的已發表數據相比更為有利。

Additionally, the data highlighted the favorable safety profile of this novel combination. There were no treatment-related discontinuations, and less than 3% of patients experienced Grade 3 stomatitis. This data indicate that the optimal gedatolisib dose for this patient population may not yet have been reached, and we believe it's important to explore additional dose options for gedatolisib. And as such, we amended the clinical trial protocol to enable exploration of additional doses in the Phase 1b portion of this clinical trial to determine the recommended Phase 2 dose.

此外，數據也凸顯了這種新型組合的良好安全性。沒有出現與治療相關的停藥情況，少於 3% 的患者出現 3 級口腔炎。這些數據表明，對於該患者群體來說，最佳的 gedatolisib 劑量可能尚未達到，我們認為探索 gedatolisib 的其他劑量選擇非常重要。因此，我們修改了臨床試驗方案，以便在該臨床試驗的 1b 期部分探索額外的劑量，以確定建議的 2 期劑量。

In addition to announcing the encouraging preliminary data from our prostate cancer trial, we also announced encouraging data from an investigator-sponsored Phase 2 clinical trial. In this trial, 44 patients with HER2-positive PIK3CA-mutated breast cancer were treated with gedatolisib plus standard doses of a trastuzumab biosimilar.

除了宣布前列腺癌試驗令人鼓舞的初步數據外，我們還宣布了由研究者發起的 2 期臨床試驗令人鼓舞的數據。在本次試驗中，44 名 HER2 陽性 PIK3CA 突變乳癌患者接受了 gedatolisib 加標準劑量的曲妥珠單抗生物相似藥治療。

No prophylaxis for stomatitis was administered. The median number of prior anti-HER2 therapies enrolled patients received in the metastatic setting was four or more. 86% of patients had received at least three prior anti-HER2 therapies, so these patients were heavily pretreated. The overall response rate was 43%, and no patients discontinued gedatolisib due to a treatment-related adverse event.

沒有採取任何口腔炎預防措施。在轉移性患者中，接受過 4 次或以上抗 HER2 治療的患者中，86% 的患者之前至少接受過 3 次抗 HER2 治療，因此這些患者接受過大量預先治療。整體反應率為 43%，沒有患者因治療相關不良事件而停止使用 gedatolisib。

Achieving 43% overall response rate in patients receiving a fourth or fifth line of anti-HER2 treatment for their disease is very encouraging and compares favorably to published data for other available therapies in this group of patients. It also suggests to gedatolisib, in combination with HER2 targeted therapy, may be an effective and well-tolerated therapeutic option for patients with HER2-positive metastatic breast cancer.

對於接受第四線或第五線抗 HER2 治療的患者來說，實現 43% 的總體反應率是非常令人鼓舞的，並且與該組患者中其他可用療法的已發表數據相比具有優勢。這也表明，gedatolisib 與 HER2 標靶治療相結合，可能成為 HER2 陽性轉移性乳癌患者的有效且耐受性良好的治療選擇。

Now, I'd like to turn to a few corporate updates. First, US Patent and Trademark Office issued Celcuity a new patent covering the clinical dosing regimen for gedatolisib in HR-positive, HER2-negative breast cancer patients. The patent extends gedatolisib's patent exclusivity in the US into 2042. And with this added patent exclusivity, we expect to have a long runway to optimize development of gedatolisib.

現在，我想介紹一些公司的最新動態。首先，美國專利商標局向Celcuity頒發了一項新專利，涵蓋了Gedatolisib在HR陽性、HER2陰性乳癌患者中的臨床給藥方案。該專利將 gedatolisib 在美國專利獨佔期延長至 2042 年。憑藉這一額外的專利獨佔權，我們期望能夠擁有長期的時間來優化 gedatolisib 的開發。

And last but not least, we also completed concurrent offerings of convertible notes, common stock, and pre-funded warrants with net proceeds of $286.5 million at the end of July and beginning of August. With the current resources and other financing arrangements, we believe we are well-positioned to advance multiple blockbuster indications in breast and prostate cancer and to aggressively prepare for and launch gedatolisib commercially should we receive FDA approval.

最後但同樣重要的一點是，我們還完成了可轉換票據、普通股和預先出資認股權證的同步發行，截至 7 月底和 8 月初的淨收益為 2.865 億美元。憑藉現有的資源和其他融資安排，我們相信，我們已做好準備，推動乳癌和前列腺癌領域的多項重磅藥物適應症，並在獲得 FDA 批准後積極準備並推出 gedatolisib 的商業化產品。

I'd like now to hand the call over to Vicky Hahne, our CFO, to review our finances.

現在我想將電話交給我們的財務長 Vicky Hahne，來審查我們的財務狀況。

Thank you, Brian, and good afternoon, everyone. I'll provide a brief overview of our financial results for the second quarter of 2025. Our second-quarter net loss was $45.3 million, or $1.04 per share, compared to $23.7 million net loss, or $0.62 per share, for the second quarter of 2024.

謝謝你，布萊恩，大家下午好。我將簡要概述我們 2025 年第二季的財務表現。我們第二季的淨虧損為 4,530 萬美元，即每股 1.04 美元，而 2024 年第二季的淨虧損為 2,370 萬美元，即每股 0.62 美元。

Our non-GAAP adjusted net loss was $40.5 million, or $0.93 per share, for the second quarter of 2025 compared to non-GAAP adjusted net loss of $22.2 million, or $0.58 per share, for the second quarter of 2024.

2025 年第二季度，我們的非 GAAP 調整後淨虧損為 4,050 萬美元，即每股 0.93 美元，而 2024 年第二季的非 GAAP 調整後淨虧損為 2,220 萬美元，即每股 0.58 美元。

Research and development expenses were $40.2 million for the second quarter of 2025 compared to $22.5 million for the second quarter of 2024. Of the approximately $15.7 million increased in R&D expenses, $6.6 million was related to increased employee and consulting expenses; $6.1 million was related to increased research and development costs, primarily attributable to activities supporting our ongoing clinical trials; and $5 million is related to an anticipated development milestone payment under the license agreement with Pfizer.

2025 年第二季研發費用為 4,020 萬美元，而 2024 年第二季為 2,250 萬美元。在增加的約 1,570 萬美元研發費用中，660 萬美元與員工和諮詢費用增加有關；610 萬美元與增加的研發成本有關，主要歸因於支持我們正在進行的臨床試驗的活動；500 萬美元與根據與輝瑞簽訂的許可協議預期的開發里程碑付款有關。

General and administrative expenses were $3.8 million for the second quarter of 2025, compared to $1.8 million for the second quarter of 2024. Of the $2 million increase in general and administrative expenses, $1.6 million was related to increased employee and consulting expenses. The remaining $0.4 million of the $2 million increase resulted from professional fees, expanding infrastructure, and other administrative expenses.

2025 年第二季的一般及行政費用為 380 萬美元，而 2024 年第二季為 180 萬美元。在一般和行政費用增加的 200 萬美元中，有 160 萬美元與員工和諮詢費用的增加有關。200 萬美元增幅中的剩餘 40 萬美元來自專業費用、擴大基礎設施和其他管理費用。

Net cash used in operating activities for the second quarter of 2025 was $36.2 million, compared to $18.1 million for the second quarter of 2024. We ended the quarter with approximately $168.4 million of cash, cash equivalents, and short-term investments. However, on a pro forma basis, taking into account the net proceeds of our financing activities in Q3, cash, cash equivalents, and short-term investments as of the end of Q2 2025 was approximately $455 million.

2025 年第二季經營活動所用淨現金為 3,620 萬美元，而 2024 年第二季為 1,810 萬美元。本季末，我們擁有約 1.684 億美元的現金、現金等價物和短期投資。然而，以備考基礎計算，考慮到我們第三季融資活動的淨收益，截至 2025 年第二季末的現金、現金等價物和短期投資約為 4.55 億美元。

Additionally, existing financing arrangements are expected to give us access to an incremental $116 million of cash over the next few quarters, $80 million from our current term loan agreement, and $36 million from the exercise of soon-to-expire in the money warrants. As a result, we believe we have the resources and financing in place to fund our operations through 2027.

此外，現有的融資安排預計將使我們在未來幾季獲得 1.16 億美元的增量現金，其中 8,000 萬美元來自我們目前的定期貸款協議，3,600 萬美元來自即將到期的貨幣認股權證的行使。因此，我們相信我們擁有足夠的資源和資金來支持我們到 2027 年的營運。

I will now hand the call back to Brian.

我現在將把電話交還給布萊恩。

Thank you, Vicki. Operator, could you please open the call for questions? Thank you very much.

謝謝你，薇琪。接線生，您能打開電話詢問嗎？非常感謝。

(Operator Instructions) Maury Raycroft, Jefferies.

（操作員指示）Maury Raycroft，Jefferies。

Hi. This is Amin on for Mori. Thank you for taking our questions and congrats on all the progress. A couple of questions from us. First, regarding the upcoming full data presentation later this year for PIK3CA wild-type portion of the Phase 3 study, can you elaborate on what we should expect to see? Specifically, will you be sharing subgroup analysis such as PFS and OS for ESR-1 wild-type and mutant cohorts there? And then I have a follow-up.

你好。這是阿明代替莫里上場。感謝您回答我們的問題，並祝賀我們取得的所有進展。我們有幾個問題。首先，關於今年稍後即將發布的 PIK3CA 野生型第 3 階段研究部分的完整數據展示，您能詳細說明我們應該期待看到什麼嗎？具體來說，您會在那裡分享 ESR-1 野生型和突變型隊列的亞組分析，例如 PFS 和 OS 嗎？然後我有一個後續問題。

Sure. We'll be focused on our initial data presentation on the primary analyses, primary endpoints, and then we would expect to present data at subsequent meetings, additional subgroup analyses.

當然。我們將專注於主要分析、主要終點的初步數據展示，然後我們希望在後續會議上展示數據和其他亞組分析。

Okay, sounds good. And for the PIK3CA mutant population, how are you thinking about the benchmarks for success here? Is there a specific hazard ratio or PFS delta that you are considering a meaningful threshold there and could be considered clinically meaningful?

好的，聽起來不錯。對於 PIK3CA 突變群體，您如何看待成功的基準？是否存在一個特定的風險比或 PFS 增量，您認為這是一個有意義的閾值，並且可以被認為具有臨床意義？

Sure. So I think there are two thresholds to consider when we're reviewing the data in that cohort. The first is the comparison to the control, which in this case is opalypsib and fulvestrant. As it turns out, given what we think is the likely outcome based on historical data for opalypsib in this population of between let's say seven to eight months, a statistically significant result would also be a clinically meaningful result of a little less than three months. So we think if we have a positive study, we'll also be reporting clinically meaningful results.

當然。因此我認為，當我們審查該群體的數據時，需要考慮兩個閾值。首先是與對照組的比較，在本例中是 opalypsib 和氟維司群。事實證明，根據我們根據該族群中 opalypsib 的歷史數據得出的可能結果，假設時間為七到八個月，那麼具有統計意義的結果也將是略少於三個月的具有臨床意義的結果。因此我們認為，如果我們進行一項積極的研究，我們也將報告具有臨床意義的結果。

Additionally, because opalypsib is probably no longer the primary option that physicians are relying on, we think from a practical standpoint, the benchmark data that physicians will consider will be the data for capivacetor, an AKT inhibitor.

此外，由於 opalypsib 可能不再是醫生所依賴的主要選擇，我們認為從實際角度來看，醫生將考慮的基準數據將是 AKT 抑制劑 capivacetor 的數據。

And capi data is reported data in the post-CDK population of about five and a half months of median PFS. So if we're able to report positive results relative to opalypsib, and those will be especially positive relative to our capivacetor.

而 capi 數據是報告的 CDK 後人群中約五個半月的中位 PFS 數據。因此，如果我們能夠報告與 opalypsib 相關的正面結果，那麼這些結果對我們的 capivacetor 來說將尤其積極。

Okay. Sounds good. Thank you.

好的。聽起來不錯。謝謝。

You're welcome.

不客氣。

Tara Bancroft, TD Cowen.

塔拉·班克羅夫特（Tara Bancroft），TD Cowen。

Hi. This is Frances on for Tara Bancroft. So just one question on our end. So since the full safety data isn't broken out in the top line, is there any more detail you can offer ahead of it? If there's better rates observed, was that overall rates or just Grade 3 somatitis end?

你好。這是弗朗西斯 (Frances) 為塔拉·班克羅夫特 (Tara Bancroft) 主持的節目。所以我們只想問一個問題。那麼，由於完整的安全資料沒有在第一行列出，您能否提前提供更多詳細資訊？如果觀察到更好的發生率，那麼這是總體發生率還是只是 3 級軀體炎結束？

Sure. So we'll be providing that data at the upcoming conference. We were really only at this stage able to provide a general summary of what we saw, but the additional detail will be forthcoming.

當然。因此我們將在即將召開的會議上提供這些數據。目前我們實際上只能對所見內容進行概括總結，但更多細節即將公佈。

Thank you.

謝謝。

You're welcome.

不客氣。

Andrew Behrens, Leerink Partners.

Leerink Partners 的 Andrew Behrens。

Hi. Good afternoon. This is Eason on for Andy. Congrats on all the progress, and thanks for taking our questions. Just a two-parter if I can. So we noticed across various pivotal trials in the HR-positive, HER2-negative breast cancer space, it's been mixed whether the PFS primary endpoint was based on BICR, as is the case in VIKTORIA-1, or based on investigator assessment.

你好。午安.這是 Eason 代替 Andy 的表演。恭喜您取得的所有進展，並感謝您回答我們的問題。如果可以的話，我只拍兩個部分。因此，我們注意到，在 HR 陽性、HER2 陰性乳癌領域的各種關鍵試驗中，PFS 主要終點是基於 BICR（如 VIKTORIA-1 的情況）還是基於研究者的評估，結果不一。

So first question is, can we expect the PFS analysis based on investigator assessment to be presented at an upcoming meeting later this year? And then second, what is the company's understanding on the concordance between BICR versus investigator assessment based on what we've seen in prior HR-positive, HER2-negative trials, as well as how is this aspect evaluated by FDA and other regulatory agencies? Thank you.

所以第一個問題是，我們是否可以期待在今年稍後召開的會議上展示基於研究者評估的 PFS 分析？其次，根據我們在先前 HR 陽性、HER2 陰性試驗中看到的情況，公司對 BICR 與研究者評估之間的一致性有何理解，以及 FDA 和其他監管機構如何評估這方面？謝謝。

Sure. No, thanks. So the selection of BICR for our study as the assessment method was a function of our study being an open-label study, and that just reflects that gedatolisib is an IV-administered drug, and you can't really have a plausible placebo.

當然。不，謝謝。因此，我們選擇 BICR 作為研究評估方法，是因為我們的研究是一項開放標籤研究，這反映了 gedatolisib 是一種靜脈注射藥物，而你不可能真正得到合理的安慰劑。

And you use blinded assessment of the scans to ensure that you're eliminating the potential for investigator bias. And that's why you saw -- see that the trials for the recent oral SERDs the EMERALD trial and the VERITAC-2 trial were also BICR studies because, again, not plausible to create a placebo for fulvestrant.

並且您使用盲法評估掃描結果以確保消除調查人員偏見的可能性。這就是為什麼您會看到——最近的口服 SERD、EMERALD 試驗和 VERITAC-2 試驗也是 BICR 研究，因為再次強調，為氟維司群創建安慰劑是不合理的。

And so BICR is the method that the FDA actually encourages or recommends when you do have an open-label study for that purpose. And so in this case then, the investigator data is really simply collected as part of ongoing assessment. And it's more for exploratory sensitivity analysis. And so it's not a fundamental analysis and we'll be reporting data as I indicated earlier in the sequence as we move from one conference to another.

因此，當您為此目的進行開放標籤研究時，BICR 實際上是 FDA 鼓勵或推薦的方法。因此在這種情況下，研究人員的數據實際上只是作為持續評估的一部分進行收集。它更適合探索性敏感度分析。因此，這不是一項基本面分析，正如我之前在序列中指出的那樣，當我們從一個會議轉到另一個會議時，我們將報告數據。

But into your question regarding concordance, I think I saw one study that showed the concordance between the hazard ratios of a bigger PFS and the investigator-assessed PFS were, I think, correlated well over 90%. It might even have been 95%. And so we do not expect to have any issues on that front.

但是關於您關於一致性的問題，我認為我看到過一項研究表明，更大的 PFS 的風險比和研究者評估的 PFS 之間的一致性，我認為相關性遠高於 90%。甚至可能達到 95%。因此我們預計在這方面不會有任何問題。

We've -- and the processes we prepare for NDA doing sensitivity analyses, many of which are prescribed by the FDA in our discussions with them about our statistical analysis plan. And all the sensitivity analyses are indicating that our data is very robust and we're very comfortable and confident about the package that we expect to submit to the FDA.

我們為 NDA 準備的流程是進行敏感度分析，其中許多都是 FDA 在我們與 FDA 討論統計分析計劃時規定的。所有敏感度分析都顯示我們的數據非常可靠，我們對即將提交給 FDA 的方案非常放心和有信心。

Great. Thank you.

偉大的。謝謝。

Stephen Willey, Stifel.

史蒂芬威利（Stephen Willey），Stifel。

Yeah. Good afternoon. Thanks for taking the question. I was just wondering how you're now thinking about launch readiness. You're going to be filing an NDA here in the fourth quarter. You've got breakthrough. Presumably, there's an RTOR pathway you can leverage.

是的。午安.感謝您回答這個問題。我只是想知道您現在對於發布準備有何看法。您將在第四季在此提交一份保密協議。你已取得突破。據推測，您可以利用一條 RTOR 路徑。

So what are some of the comps, I guess, that you look to in terms of the requisite amount of infrastructure build that you need? And how do you think about scaling that infrastructure here over the near term and as we get into '26?

那麼，我想，就您所需的基礎設施建設數量而言，您會考慮哪些比較對象呢？您認為在短期內以及進入 26 年後如何擴大這裡的基礎設施？

Sure. No, that's a great question. So it's a couple points to highlight. First, we began building our team last year. We hired our Chief Commercial Officer, Eldon Mayer in first quarter of 2024, and then he, in turn, brought on board a head of marketing, head of market access, head of commercial operations. And they focused on projects that have a long lead time and there are a variety of those that can take up to 18 months to get done.

當然。不，這是一個很好的問題。因此，有幾點需要強調。首先，我們從去年就開始組建我們的團隊。我們於 2024 年第一季聘請了首席商務官 Eldon Mayer，隨後他又任命了行銷主管、市場准入主管和商業營運主管。他們專注於那些需要較長準備時間的項目，其中有些項目可能需要長達 18 個月才能完成。

And so, essentially, we've been working back from a launch date. You have to assume an earlier launch date or you're aggressive on when you think that'll occur just so you're not blindsided and you're ready under any circumstance.

因此，從本質上講，我們一直在從發布日期開始進行工作。您必須假設一個更早的發布日期，或者您對發佈時間有積極的預期，這樣您就不會措手不及，並且可以在任何情況下做好準備。

And now as we've gotten closer to launch these past few months, we've begun hiring the individuals who report up to the heads of these various departments. And in turn, they've been taking on more projects. Now that we have our data, we have what we think is a clear path to an approval decision, which we can -- where we can define with some degree of confidence a launch date, we'll be taking that next step.

現在，隨著我們在過去幾個月中越來越接近發布，我們已經開始招募向各部門負責人報告的人員。反過來，他們也承擔了更多的專案。現在我們有了數據，我們認為這是一條通往批准決定的明確道路，我們可以——我們可以有信心地確定發布日期，然後我們將採取下一步行動。

And so that'll involve additional infrastructure associated in the commercial operations area to support sales force, to supporting MSL force, there's activities in the market access area, engaging with payers, strategic accounts in ways that are appropriate at this stage.

因此，這將涉及商業營運領域相關的額外基礎設施，以支援銷售隊伍、支援 MSL 隊伍，在市場准入領域開展活動，以現階段適當的方式與付款人和策略客戶互動。

And then in turn, you start to build out your Salesforce management structure, starting with head of sales and then regional management, which in turn requires you to define sales territories, number of territories, the geographic alignment, et cetera.

然後，您開始建立 Salesforce 管理結構，從銷售主管開始，然後是區域管理，這又要求您定義銷售區域、區域數量、地理位置等等。

So all those projects are on track. and as far as how are we doing or what is our benchmark? We've been very deliberate about hiring folks in all of these key positions, people who have been involved in first launch of a company's drug, first drug launch for a company.

所以所有這些項目都在按計劃進行。至於我們做得怎麼樣或我們的基準是什麼？我們在招募所有這些關鍵職位的人員時都非常謹慎，這些人員都曾參與過公司藥物的首次上市，也曾為公司推出過首款藥物。

And that's critical because there's so much infrastructure, operational support activities that are required to be effective as a commercial organization. It's not a plug-and-play if somebody coming from big pharma has never had to set up all of this infrastructure or to establish these processes and these functions from scratch.

這很關鍵，因為作為一個商業組織，要有效運作需要大量的基礎設施和營運支援活動。如果大型製藥公司的員工從未設置過所有這些基礎設施或從頭開始建立這些流程和功能，那麼它就不是即插即用的。

So I think we've been very, very fortunate. We've hired a great team, incredibly experienced, very focused, and I think we're absolutely on track to having what we think. We're optimistic about the launch and our ability to be very, very effective in communicating benefits of geda -- what we believe are the benefits of geda to medical oncologists.

所以我認為我們非常非常幸運。我們聘請了一支優秀的團隊，他們經驗豐富、專注力強，我認為我們完全可以實現我們的想法。我們對此次發布以及我們非常有效地傳達 geda 益處的能力感到樂觀——我們相信 geda 對腫瘤內科醫生有益。

All right. Thanks for taking the question.

好的。感謝您回答這個問題。

You're welcome.

不客氣。

Gil Blum, Needham & Company.

吉爾·布魯姆（Gil Blum），Needham & Company。

Hi This is [Gil] for Gil. So, just a couple from us. Can you put into context the practical ramifications for physicians now that they may have optionality with both a doublet and a triplet? And I have a follow-on.

你好，我是 Gil 的 [Gil]。所以我們只有一對夫婦。您能否解釋一下現在醫生可以選擇雙重和三重療法所帶來的實際影響？我還有一個後續問題。

Well, I think the primary, I think, goal of all these physicians is to optimize and delay as long as possible the progression of a patient's disease, and the triplet offers that to these doctors. Now, the triplet, because it includes polycycline, also induces some myelosuppression which for patients who could be elderly or have an immune system that may be more compromised, they may consider not to be appropriate.

嗯，我認為所有這些醫生的主要目標是盡可能優化和延緩患者病情的進展，三聯療法為這些醫生提供了這一點。現在，由於三重療法中含有多環素，也會引起一些骨髓抑制，對於老年或免疫系統可能較弱的患者來說，他們可能認為不合適。

And so, they'll have the option of still getting very, very, what we believe, extended incremental benefit in PFS. And so, what we think having either regimen available does is allow us to have access to as broad a range of patients as possible.

因此，他們仍然可以選擇獲得我們認為的 PFS 中的非常大的增量利益。因此，我們認為，只要有這兩種療法，我們就能接觸到盡可能廣泛的患者。

And that's always great. And then, I think as we get into and describe results for different subgroups, I think that will help guide some of the decision-making for different subgroups for physicians and how they might want to think about the doublet versus the triplet as an example.

這總是很棒的。然後，我認為當我們進入並描述不同亞組的結果時，我認為這將有助於指導醫生針對不同亞組做出一些決策，以及他們如何以雙聯體和三聯體為例來思考。

Thank you, very helpful. And just as a follow-on to Steve's question, is there any consideration on commercial partnering strategy for a launch? I mean, it looks like it might be a very large investment just given the size of the market. Thank you.

謝謝，非常有幫助。作為史蒂夫問題的後續，在發布產品時是否考慮過商業合作策略？我的意思是，考慮到市場的規模，這看起來可能是一項非常大的投資。謝謝。

No, we're expecting and planning to launch ourselves. We think we understand what's required. We know what's required. We have a very, very detailed operating plan and operating budget. We know what the headcount is and why we need to bring them on. The investment is not insignificant, but it's not ridiculous, to be frank.

不，我們期待併計劃自己推出。我們認為我們了解需要什麼。我們知道需要什麼。我們有非常非常詳細的營運計劃和營運預算。我們知道員工人數是多少，以及為什麼我們需要招募他們。坦白說，這項投資雖然不小，但也不荒謬。

And relative to the size of the opportunity, it's very manageable. And so we've financed ourselves accordingly. That's the other part of the equation obviously is having sufficient capital to invest aggressively in a launch.

相對於機會的規模來說，這是非常容易管理的。因此，我們相應地籌集了資金。顯然，等式的另一部分是擁有足夠的資本來積極投資新產品。

And we think we've set ourselves up very well with our balance sheet to do that. And so just purely from a financial perspective and financial return perspective, it makes absolute sense for us to be launching this ourselves and not to be partnering with somebody.

我們認為，我們的資產負債表已經為實現這一目標做好了充分準備。因此，僅從財務角度和財務回報角度來看，我們自己啟動這個專案而不是與別人合作是絕對合理的。

Thanks for taking our questions.

感謝您回答我們的問題。

You're welcome.

不客氣。

Chase Knickerbocker, Craig-Hallum.

蔡斯·尼克博克、克雷格·哈勒姆。

Good afternoon. Thanks for taking the questions. Maybe, Brian, just to start, can you just give us your general thoughts on the competitive landscape in the mutant population? There's, obviously, some other actionable mutations in there with ESR, et cetera. So can you just give us your general two early thoughts as far as the competitive environment there and how you see geda fitting in?

午安.感謝您回答這些問題。布萊恩，首先，您能否先跟我們講講您對變種人群體競爭格局的整體看法？顯然，其中還存在一些與 ESR 等有關的可操作突變。那麼，您能否就那裡的競爭環境以及您如何看待 Geda 的適應情況，向我們提供兩點初步想法？

Right. So I think two things. I mean, for PIK3CA mutation patients, we'll be reporting out that data later this year. Obviously, if our data is positive and shows benefit relative to opalypsib, we think that'll position us very well to establish geda as a new potential standard of care. So we'll be taking -- we think that'll speak for itself.

正確的。所以我想到了兩件事。我的意思是，對於 PIK3CA 突變患者，我們將在今年稍後報告該數據。顯然，如果我們的數據是積極的並且顯示出相對於 opalypsib 的優勢，我們認為這將使我們能夠很好地將 geda 確立為一種新的潛在護理標準。所以我們會採取——我們認為這將不言而喻。

As far as the ESR1 mutations, we just don't think they'll be as relevant given the nature of the drug combination that we have. In the absence of inhibition of, let's say, CDK4-6 or the PAM pathway, potentially in ESR1 mutant patients, I mean, data suggests that you can get some incremental benefit if you use an oral SERD to address that pathway.

就 ESR1 突變而言，考慮到我們擁有的藥物組合的性質，我們只是認為它們不會那麼重要。假設沒有抑制 CDK4-6 或 PAM 通路，那麼對於 ESR1 突變患者來說，數據表明，如果使用口服 SERD 來處理該通路，可以獲得一些增量益處。

And, at the same time, we think if you are addressing the PAM pathway and CDK4-6, the relative difference in outcomes between the SR1 mutant and wild-type patients is unlikely to be meaningfully different.

同時，我們認為，如果您正在研究 PAM 路徑和 CDK4-6，SR1 突變型患者和野生型患者之間的結果相對差異不太可能有顯著差異。

Got it. Maybe just on the mutant side to dig in a little bit there. Obviously, the most recent approval there with Itovebi, I mean, can you just give us some thoughts as far as how the market's changed in the last 10, 12 months and any relative comparisons there?

知道了。也許只是在突變方面進行一點點挖掘。顯然，Itovebi 最近獲得了批准，我的意思是，您能否就過去 10 到 12 個月市場發生的變化以及相關比較向我們提供一些看法？

Sure. So I still use the generic name, inavolisib. That drug is an alpha-PI3K alpha inhibitor. It's approved for treating patients who have a PIK3CA mutation in the first-line setting for women who have endocrine treatment-resistant disease -- advanced disease. And that's actually the patient population that we'll be -- that we're addressing in our VIKTORIA-2 study. So that population doesn't overlap at all of the population that we'll be addressing with the VIKTORIA-1 study results.

當然。所以我仍然使用通用名 inavolisib。該藥物是一種 α-PI3K α 抑制劑。它被批准用於治療患有內分泌治療難治性疾病（晚期疾病）的女性中攜帶 PIK3CA 突變的患者的一線治療。這其實就是我們在 VIKTORIA-2 研究中所針對的患者族群。因此，該族群與我們將透過 VIKTORIA-1 研究結果討論的族群完全不重疊。

And so the data does provide confirmation that in the frontline setting, treatment-naive patients have involvement for PAM pathway in their disease, and they'll benefit. In this case this drug has only shown activity -- unfavorable activity, in patients that had a PIK3CA mutation. That drug also has some induces levels of hypoglycemia that can potentially limit its use to patients who are healthy metabolically which means they they are not pre-diabetic or not diabetic at all.

因此，數據確實證實，在前線環境中，未接受治療的患者在其疾病中涉及 PAM 通路，並且他們會受益。在這種情況下，這種藥物僅對患有 PIK3CA 突變的患者表現出活性—不利的活性。該藥物還具有一定的誘發低血糖水平，這可能會限制其在代謝健康的患者中的使用，這意味著他們不是糖尿病前期或根本沒有糖尿病。

And we would hope, and that's what our trial will evaluate, that geda can be effective in treating patients independent of their PIK3CA status and independent of their metabolic status and independent of their HbA1c levels or glucose levels. And so ultimately, if our data from wild type recapitulates in the VIKTORIA-2 study and we show activity generally, we think we have another opportunity to establish geda as a potential standard of care.

我們希望，而且我們的試驗將評估的是，geda 能夠有效治療患者，無論他們的 PIK3CA 狀態、代謝狀態、HbA1c 水平或血糖水平如何。因此，最終，如果我們從野生型獲得的數據在 VIKTORIA-2 研究中重現，並且我們普遍表現出活性，我們認為我們還有另一個機會將 geda 確立為潛在的護理標準。

Thanks, Brian. And maybe just one more if I could sneak it in. On the CMC portion of your filing, when you submit it in Q4, can you just remind us your manufacturer there any specifics you wanted to give as far as your confidence around your CMC package?

謝謝，布萊恩。如果我能偷偷帶進去的話，也許還會再來一個。關於您文件中的 CMC 部分，當您在第四季度提交時，您能否提醒我們您的製造商，關於您對 CMC 封裝的信心，您想提供任何具體細節？

We're very confident about the CMC package. We have all the data. Our modules are complete for CMC. There's a very prescribed set of studies that are expected, analyses to be performed, number of demonstration of consistency of your process, and that's all been done.

我們對 CMC 套件非常有信心。我們擁有所有數據。我們的模組對於 CMC 來說是完整的。有一系列非常規定的預期研究、要進行的分析、流程一致性的證明數量，這些都已完成。

So we're very confident just based on and the robustness of the package that we've built and the data that we've generated that we should satisfy the FDA's requirements. And we've also engaged directly with the FDA and ensured that there aren't any open questions based on an outline that we've provided to them of the data we expect to provide. And so we think we should be in good shape on that front.

因此，我們非常有信心，僅基於我們所建立的包裝的穩健性和我們產生的數據，我們就應該滿足 FDA 的要求。我們還直接與 FDA 接洽，並確保根據我們向他們提供的我們預計將提供的數據概要，不存在任何懸而未決的問題。因此我們認為我們在這方面應該處於良好狀態。

Great. Thanks, Brian.

偉大的。謝謝，布萊恩。

You're welcome.

不客氣。

There are no further questions at this time. I'd like to turn the call back to Mr. Brian Sullivan for closing comments. Sir, please go ahead.

目前沒有其他問題。我想將電話轉回給 Brian Sullivan 先生，請他發表最後評論。先生，請繼續。

Well, thank you for participating in our call today, and thank you for your ongoing support. I look forward to catching up with you at various conferences along the way. Take care.

好吧，感謝您今天參加我們的電話會議，也感謝您一直以來的支持。我期待在沿途的各種會議上與您見面。小心。

Ladies and gentlemen, this concludes today's conference call. Thank you very much for your participation. You may now disconnect.

女士們、先生們，今天的電話會議到此結束。非常感謝您的參與。您現在可以斷開連線。