Celcuity Inc (CELC) 2025 Q3 法說會逐字稿

Good afternoon, ladies and gentlemen, and welcome to the Celcuity's third-quarter 2025 financial results webcast and conference call. (Operator Instructions)

女士們、先生們，下午好，歡迎參加 Celcuity 2025 年第三季財務業績網路直播和電話會議。（操作說明）

I would now like to turn the conference over to Apoorva Chaloori with ICR Healthcare. Please go ahead.

現在我將把會議交給 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 third-quarter 2025 financial results and business update. Earlier today, Celcuity Inc., released financial results for the third quarter ended September 30, 2025. The press release can be found on the Investors section of Celcuity's website.

謝謝接線員，大家下午好。感謝您參加本次會議，共同回顧 Celcuity 2025 年第三季財務業績和業務更新。今天早些時候，Celcuity Inc. 發布了截至 2025 年 9 月 30 日的第三季財務業績。新聞稿可在 Celcuity 網站的投資者關係版中找到。

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 Gorbatchevsky, Chief Medical Officer, who will be available during Q&A. 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.

今天與我一起參加電話會議的有 Celcuity 的執行長兼聯合創始人 Brian Sullivan；財務長 Vicky Hahne；以及首席醫療官 Igor Gorbatchevsky，他將在問答環節回答問題。在開始之前，我想提醒各位聽眾，我們今天的評論將包含一些前瞻性陳述。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進行了概述。

Actual events or results may differ materially from those projected in the forward-looking statements. 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.

實際事件或結果可能與前瞻性聲明中預測的內容有重大差異。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，這些因素可能導致實際結果或績效與預期結果或績效有重大差異。

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. 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.

在本次電話會議中，我們也將提及非GAAP財務指標。管理階層使用這些非GAAP指標來制定策略決策、預測未來績效和評估公司目前的績效。管理階層認為，列示這些非GAAP財務指標有助於投資人了解並評估公司目前的業務核心營運和未來前景。您可以在今天的新聞稿中找到將非GAAP財務指標與GAAP指標進行調節的表格。

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

接下來，我將把電話交給 Celcuity 的執行長 Brian Sullivan。請繼續。

Thank you, Apoorva. Good afternoon, everyone, and thank you for joining our third-quarter operating and financial update conference call. Past few months were busy and fruitful ones for Celcuity. We made significant progress achieving a number of clinical and regulatory milestones while also significantly bolstering our balance sheet. These achievements lay the groundwork for us to potentially establish gedatolisib as a new standard of care second-line therapy for patients with HR-positive, HER2-negative advanced breast cancer.

謝謝你，阿普爾瓦。各位下午好，感謝各位參加我們第三季營運和財務更新電話會議。過去幾個月對 Celcuity 來說是忙碌且富有成果的幾個月。我們在實現多項臨床和監管里程碑方面取得了重大進展，同時我們的資產負債表也得到了顯著改善。這些成就為我們奠定了基礎，有可能將 gedatolisib 確立為 HR 陽性、HER2 陰性晚期乳癌患者的二線治療新標準。

Amongst the key clinical and regulatory milestones achieved, first, we released top-line data results from the PIK3CA wild-type cohort of the Phase 3 VIKTORIA-1 study and then subsequently presented detailed efficacy and safety results for this study at a late-breaking oral presentation at the European Society for Medical Oncology, or ESMO Congress.

在取得的關鍵臨床和監管里程碑中，首先，我們發布了 VIKTORIA-1 3 期研究 PIK3CA 野生型隊列的初步數據結果，隨後在歐洲腫瘤內科學會 (ESMO) 大會上以最新口頭報告的形式，公佈了該研究的詳細療效和安全性結果。

We also presented at this ESMO Congress updated clinical results from the Phase 1 portion of a clinical trial evaluating gedatolisib in combination with darolutamide in men with metastatic castration-resistant prostate cancer. And third, we completed enrollment of the PIK3CA mutant cohort of the Phase 3 VIKTORIA-1 trial, and we now expect top-line data in late Q1 '26 or during Q2 '26.

我們也在本屆 ESMO 大會上介紹了評估 gedatolisib 與 darolutamide 聯合治療轉移性去勢抵抗性前列腺癌男性患者的臨床試驗 1 期部分的最新臨床結果。第三，我們完成了 VIKTORIA-1 3 期試驗中 PIK3CA 突變隊列的招募，現在預計將在 2026 年第一季末或 2026 年第二季獲得初步數據。

And fourth, the FDA accepted our request to submit our New Drug Application, or NDA, under their real-time oncology review program for gedatolisib based on the results from the PIK3CA wild-type cohort of the VIKTORIA-1 trial, and we expect to complete the submission this quarter. And then fifth, to strengthen our balance sheet, we completed concurrent offerings of convertible notes, common stock and prefunded warrants, which resulted in net proceeds of approximately $287 million.

第四，FDA 已接受我們根據 VIKTORIA-1 試驗中 PIK3CA 野生型隊列的結果，在其實時腫瘤審查計劃下提交 gedatolisib 的新藥申請 (NDA)，我們預計將在本季度完成提交。第五，為了加強我們的資產負債表，我們同時完成了可轉換票據、普通股和預付認股權證的發行，由此獲得了約 2.87 億美元的淨收益。

We also amended our term loan facility with Innovatus Capital Partners and Oxford Finance to increase the total term loan facility size to $500 million, including $350 million in committed capital and up to $150 million at the mutual discretion of Celcuity and its lenders. Future draws of committed capital under the facility are subject to the achievement of certain milestones.

我們也修改了與 Innovatus Capital Partners 和 Oxford Finance 的定期貸款協議，將定期貸款總額增加到 5 億美元，其中包括 3.5 億美元的承諾資本，以及 Celcuity 及其貸款人雙方酌情決定的最高 1.5 億美元。根據此融資機制，未來提取已承諾資金需滿足一定的里程碑條件。

The most consequential milestone of the quarter for Celcuity was, of course, the release of positive data from the PIK3CA wild-type cohort of the VIKTORIA-1 trial. And we've discussed previously the historic nature of the results and the new milestones they achieved in HR-positive, HER2-negative advanced breast cancer. But to recap, median progression-free survival, or PFS, for the gedatolisib triplet, which is gedatolisib, palbociclib, and fulvestrant was 9.3 months compared to only 2 months for fulvestrant, which is a 7.3-month incremental improvement in median PFS.

對於 Celcuity 而言，本季最重要的里程碑當然是 VIKTORIA-1 試驗中 PIK3CA 野生型隊列的積極數據發布。我們之前討論過這些結果的歷史意義，以及它們在 HR 陽性、HER2 陰性晚期乳癌領域中取得的新里程碑。但總而言之，吉達托利西布三合一療法（吉達托利西布、帕博西尼和氟維司群）的中位無惡化存活期（PFS）為 9.3 個月，而氟維司群單藥治療的中位無惡化存活期僅為 2 個月，中位 PFS 提高了 7.3 個月。

The hazard ratio was 0.24. For the gedatolisib doublet, which is gedatolisib and fulvestrant, median PFS was 7.4 months versus 2.0 months with fulvestrant, a 5.4-month incremental improvement in median PFS. And the hazard ratio was 0.33.

風險比為 0.24。對於 gedatolisib 雙藥（gedatolisib 和 fulvestrant），中位 PFS 為 7.4 個月，而 fulvestrant 為 2.0 個月，中位 PFS 提高了 5.4 個月。風險比為 0.33。

These results set several new benchmarks in HR-positive, HER2-negative advanced breast cancer. The hazard ratios for both the gedatolisib triplet and doublet are more favorable than have ever been reported by any Phase 3 trial for patients with HR-positive, HER2-negative ABC.

這些結果為 HR 陽性、HER2 陰性晚期乳癌設定了幾個新的基準。對於 HR 陽性、HER2 陰性 ABC 患者，gedatolisib 三聯療法和雙聯療法的風險比均優於任何 3 期試驗報告的結果。

The 7.3 and 5.4 months incremental improvements in median PFS with the gedatolisib triplet and doublet over fulvestrant, respectively, are higher than have ever been reported by any Phase 3 trial for patients with HR-positive, HER2-negative advanced breast cancer receiving at least their second line of endocrine therapy.

與氟維司群相比，吉達托利西布三重療法和雙聯療法分別使中位無進展生存期 (PFS) 延長了 7.3 個月和 5.4 個月，這一改善幅度高於任何 3 期試驗中報告的接受至少二線內分泌治療的 HR 陽性、HER2 陰性晚期乳腺癌患者的改善幅度。

And gedatolisib is the first inhibitor that targets the PI3K/AKT/mTOR pathway to demonstrate positive Phase 3 results in patients with HR-positive, HER2-negative PIK3CA wild-type breast cancer, whose disease progressed on or after treatment with a CDK4/6 inhibitor.

gedatolisib 是首個針對 PI3K/AKT/mTOR 路徑的抑制劑，在 HR 陽性、HER2 陰性、PIK3CA 野生型乳癌患者中取得了積極的 3 期臨床試驗結果，這些患者的病情在接受 CDK4/6 抑制劑治療期間或之後出現進展。

Now as a follow-up to the release of the top-line data in July, additional data were released at a late-breaking oral presentation in October at ESMO. Now in this presentation, we reported, among other things, that the objective response rate of the gedatolisib triplet was 32% compared to 1% with fulvestrant and the median duration of response was 17.5 months and that the objective response rate of the gedatolisib doublet was 28% and the median duration of response was 12.0 months. The median duration of response for fulvestrant was not determinable because there was only one objective response.

繼 7 月發布主要數據之後，10 月在 ESMO 會議上以最新口頭報告的形式發布了更多數據。在本次報告中，我們報告了以下結果：與氟維司群相比，gedatolisib 三聯療法的客觀緩解率為 32%，中位緩解持續時間為 17.5 個月；gedatolisib 雙聯療法的客觀緩解率為 28%，中位緩解持續時間為 12.0 個月。由於只有一例客觀緩解，因此無法確定氟維司群的中位數緩解持續時間。

And these results also established new benchmarks. The median duration of response and the incremental improvement in the objective response rate relative to control for the gedatolisib triplet and doublet are the highest reported for an endocrine therapy-based regimen in second-line HR-positive, HER2-negative advanced breast cancer.

這些結果也樹立了新的標竿。對於二線 HR 陽性、HER2 陰性晚期乳癌，吉達托利西布三聯療法和雙聯療法的中位緩解持續時間和客觀緩解率相對於對照組的增量改善是內分泌治療方案中報道的最高水平。

Additionally, the results demonstrated the clinical benefit of the gedatolisib regimens was consistent across patient subgroups. And one patient subgroup of note, patients enrolled in the United States and Canada, achieved median PFS of 19.3 months with the gedatolisib triplet and 14.9 months with the gedatolisib doublet. The ESMO presentation also provided detailed safety results that showed the gedatolisib triplet and doublet were generally well tolerated in the trial with mostly low-grade treatment-related adverse events.

此外，結果表明，gedatolisib 治療方案的臨床效益在各個患者亞組中均保持一致。值得注意的是，在美國和加拿大入組的患者亞組中，接受 gedatolisib 三聯療法的患者中位 PFS 為 19.3 個月，接受 gedatolisib 雙聯療法的患者中位 PFS 為 14.9 個月。ESMO 的報告還提供了詳細的安全性結果，顯示在試驗中，gedatolisib 三聯療法和雙聯療法整體耐受性良好，主要為低度治療相關不良事件。

Study treatment discontinuation due to treatment-related adverse events was reported in 2.3% of patients treated with the gedatolisib triplet and 3.1 months of patients with the gedatolisib doublet. Now in the presentation of results from the PIK3CA wild-type cohort of the VIKTORIA-1 study at ESMO, additional data from a Phase 1b clinical trial that evaluated gedatolisib in patients with HR-positive, HER2-negative advanced breast cancer was included. And the analyses reported efficacy data from patients who are treated with the same drug regimen evaluated in the VIKTORIA-1 study, gedatolisib combined with fulvestrant and palbociclib.

接受 gedatolisib 三聯療法治療的患者中有 2.3% 報告因治療相關不良事件而停止研究治療，接受 gedatolisib 雙聯療法治療的患者中有 3.1 個月報告因治療相關不良事件而停止研究治療。現在，在 ESMO 會議上公佈 VIKTORIA-1 研究的 PIK3CA 野生型隊列的結果時，還納入了來自一項 1b 期臨床試驗的額外數據，該試驗評估了 gedatolisib 在 HR 陽性、HER2 陰性晚期乳腺癌患者中的療效。分析報告顯示，接受 VIKTORIA-1 研究中評估的相同藥物方案（gedatolisib 合併 fulvestrant 和 palbociclib）治療的患者的療效數據。

Now these patients were included from the escalation Arm B and expansion Arms B, C and D of the Phase 1b study. Median PFS and the objective response rate, or ORR, were assessed in subgroups of patients according to their PIK3CA status. For the 30 analyzed patients with PIK3CA mutant tumors, median PFS was 14.6 months and the ORR in response of evaluable patients was 48%. For the 60 patients with PIK3CA wild-type tumors, median PFS was nine months and the ORR in response evaluable patients was 41%.

現在，這些患者均來自 1b 期研究的升級組 B 和擴展組 B、C 和 D。根據 PIK3CA 狀態，對患者亞組進行中位 PFS 和客觀緩解率 (ORR) 評估。在分析的 30 例 PIK3CA 突變腫瘤患者中，中位 PFS 為 14.6 個月，可評估患者的 ORR 為 48%。對於 60 位 PIK3CA 野生型腫瘤患者，中位 PFS 為 9 個月，可評估療效的患者的 ORR 為 41%。

Now let's turn over to our VIKTORIA-2 study, which is a Phase 3 clinical trial evaluating gedatolisib plus a CDK4/6 inhibitor and fulvestrant as first-line treatment for patients with HR-positive, HER2-negative advanced breast cancer who are endocrine therapy resistant. We dosed the first patient for this study in late July and enrollment is ongoing. We believe the positive results from the PIK3CA wild-type cohort of our VIKTORIA-1 study augurs well for the potential efficacy of gedatolisib triplet may induce in this patient population.

現在讓我們來看看 VIKTORIA-2 研究，這是一項 3 期臨床試驗，旨在評估 gedatolisib 加 CDK4/6 抑製劑和氟維司群作為 HR 陽性、HER2 陰性且對內分泌治療耐藥的晚期乳腺癌患者的一線治療方案。我們在7月下旬給第一位患者進行了給藥，目前患者招募工作仍在進行中。我們相信，VIKTORIA-1 研究中 PIK3CA 野生型隊列的積極結果預示著 gedatolisib 三聯療法可能在該患者群體中產生良好的療效。

Now let's turn to our Phase 1/2 clinical trial that is evaluating gedatolisib in combination with darolutamide in men with metastatic castration-resistant prostate cancer. We presented detailed data for the Phase 1 portion of the study at a poster presentation at ESMO. And in this portion of the Phase 1/2 study, 38 patients were randomly assigned to receive standard doses of gedatolisib in either 120 milligrams of gedatolisib in Arm 1 or 180 milligrams of gedatolisib in Arm 2.

現在讓我們來看看我們正在進行的 1/2 期臨床試驗，該試驗評估了 gedatolisib 與 darolutamide 聯合治療轉移性去勢抵抗性前列腺癌男性患者的療效。我們在 ESMO 會議上以海報形式展示了該研究 1 期部分的詳細數據。在這項 1/2 期研究的這一部分中，38 名患者被隨機分配接受標準劑量的 gedatolisib，其中 1 組接受 120 毫克 gedatolisib，2 組接受 180 毫克 gedatolisib。

Among the 38 patients enrolled, 61% had received one line of prior systemic therapy and 39% had received at least two or more lines of prior therapy. The Phase 1 data set utilized in August 15, 2025, data cutoff and median duration of follow-up was nine months.

在入組的 38 名患者中，61% 的患者接受過一線全身治療，39% 的患者接受過至少兩線或兩線以上的治療。2025 年 8 月 15 日使用的第一階段資料集，資料截止日期為 2025 年 8 月 15 日，中位追蹤時間為 9 個月。

The six-month radiographic PFS, or rPFS rate was 67% and the median radiographic progression-free survival for patients was 9.1 months from both arms combined. For patients treated with 120 milligrams of gedatolisib, the six month rPFS rate was 74% and the median rPFS was 9.5 months.

六個月放射學無惡化存活期（rPFS）率為 67%，兩組患者的中位放射學無惡化存活期為 9.1 個月。對於接受 120 毫克 gedatolisib 治療的患者，6 個月 rPFS 率為 74%，中位 rPFS 為 9.5 個月。

For patients treated with 180 milligrams of gedatolisib, the 6-month PFS rate was 61% and the median rPFS was 7.4 months. And these results compare favorably to historical results for patients with mCRPC who were treated with an androgen receptor inhibitor as second-line treatment.

對於接受 180 毫克 gedatolisib 治療的患者，6 個月 PFS 率為 61%，中位 rPFS 為 7.4 個月。與接受雄性激素受體抑制劑作為二線治療的 mCRPC 患者的歷史結果相比，這些結果令人滿意。

The combination of geda and darolutamide were generally well tolerated in the trial with mostly low-grade treatment-related adverse events. No dose-limiting toxicities were observed in either arm. The only Grade 3 treatment-related adverse events for patients from both arms combined included rash in about 5.3% of patients, stomatitis in 2.6% of patients, and pruritus in 2.6% of patients as well. No Grade 3 hypoglycemia was reported. Additionally, no patients discontinued the study treatment due to an adverse event.

試驗中，吉達和達羅魯胺的組合整體耐受性良好，主要表現為低度的治療相關不良事件。兩組均未觀察到劑量限制性毒性。兩組患者中唯一與治療相關的 3 級不良事件包括：約 5.3% 的患者出現皮疹，2.6% 的患者出現口腔炎，以及 2.6% 的患者出現搔癢。未報告3級低血糖事件。此外，沒有患者因不良事件而停止研究治療。

Now as we near what we hope is an FDA approval for gedatolisib in 2026, our efforts to prepare for the potential launch of gedatolisib have ramped up per our strategic launch plan. Foundational to these efforts was the additional cash we raised and the enhanced financial flexibility, our $500 million term loan facility provides us. We began laying the groundwork for a potential gedatolisib launch 18 months ago, and we've since made significant progress building the organization and internal systems required to operate as a commercial stage company.

現在，隨著我們希望 gedatolisib 在 2026 年獲得 FDA 批准，我們根據戰略上市計劃加大了為 gedatolisib 的潛在上市做準備的力度。這些努力的基礎是我們籌集的額外資金和增強的財務靈活性，這得益於我們 5 億美元的定期貸款安排。18 個月前，我們開始為 gedatolisib 的潛在上市做準備，此後我們在建立作為商業化階段公司運營所需的組織和內部系統方面取得了重大進展。

Now as planned, once the VIKTORIA-1 wild-type data was in hand, our commercial launch preparation efforts significantly accelerated. Except for the field sales force, we've mostly completed hiring of the individuals needed to execute the launch, and we're very fortunate to have attracted an incredibly talented group of individuals who have a strong track record of successfully launching novel oncology therapeutics.

現在，正如計劃的那樣，一旦掌握了 VIKTORIA-1 野生型數據，我們的商業發射準備工作就顯著加快了。除了現場銷售團隊之外，我們已經基本完成了產品上市所需人員的招募工作，我們非常幸運地吸引了一群才華橫溢的人才，他們在成功推出新型腫瘤療法方面有著良好的業績記錄。

Our sales management and customer operations groups have defined our regional and sales territories and our go-to-market objectives for each one. The medical science liaison and KOL engagement teams have done a great job of exchanging scientific information with key opinion leaders and community practice leaders and obtaining important insights and feedback from them.

我們的銷售管理和客戶營運團隊已經確定了我們的區域和銷售區域，以及每個區域的市場推廣目標。醫學科學聯絡和關鍵意見領袖參與團隊在與關鍵意見領袖和社區實踐領袖交流科學資訊以及從他們那裡獲得重要見解和回饋方面做得非常出色。

Now key efforts today include extensive outreach across the country to the payers and population health decision-makers in various treatment settings, including health systems, integrated delivery networks, and community oncology practices that will play a key role in providing oncologists access to gedatolisib for their patients. We've made strong progress engaging with these decision-makers, and we're very pleased with the feedback and enthusiastic response these efforts have yielded.

目前，關鍵措施包括在全國廣泛接觸各種治療場所的支付方和人口健康決策者，包括醫療系統、綜合服務網絡和社區腫瘤診所，這些機構將在為腫瘤醫生提供 gedatolisib 治療患者方面發揮關鍵作用。我們在與這些決策者的溝通方面取得了顯著進展，我們對這些努力所獲得的回饋和熱情回應感到非常滿意。

We're also very encouraged by the results of research we have fielded to gauge the willingness of community and academic oncologists to prescribe gedatolisib should it get approved. And these results make us optimistic about the possibility of establishing gedatolisib as the new standard of care in the second-line setting for HR-positive, HER2-negative advanced breast cancer in the wild-type patient population.

我們也對我們所進行的研究結果感到非常鼓舞，這些研究旨在評估社區和學術腫瘤學家在 gedatolisib 獲得批准後是否願意開立該藥。這些結果讓我們對將 gedatolisib 確立為野生型患者群體中 HR 陽性、HER2 陰性晚期乳癌二線治療的新標準充滿信心。

Now in light of this feedback, we believe obtaining majority market share in this setting appears not only achievable but potentially too conservative. Based on analysis of published epidemiological data, we estimate there are 37,000 patients in the US with HR-positive, HER2-negative advanced breast cancer who've progressed after treatment with a CDK4/6 inhibitor.

現在根據這些回饋，我們認為在當前情況下獲得多數市場份額不僅可以實現，而且可能過於保守。根據已發表的流行病學數據的分析，我們估計美國有 37,000 名 HR 陽性、HER2 陰性晚期乳癌患者在接受 CDK4/6 抑制劑治療後病情進展。

Using internal duration of treatment estimates and pricing assumptions consistent with currently available novel therapeutics for breast cancer, we estimate the total addressable market for gedatolisib in the second-line setting is $5 billion to $6 billion. And given the significant penetration our research is suggesting we can achieve, we believe it's reasonable to estimate that a second-line wild-type indication or second-line indication in general for gedatolisib can potentially generate peak revenues of $2.5 billion to $3 billion.

根據內部治療持續時間估計和與目前可用的乳癌新療法一致的定價假設，我們估計 gedatolisib 在二線治療中的潛在市場總額為 50 億至 60 億美元。鑑於我們的研究表明我們可以獲得顯著的市場滲透率，我們認為可以合理估計，gedatolisib 作為二線野生型適應症或一般二線適應症，其潛在峰值收入可達 25 億至 30 億美元。

The progress we've made to date is encouraging and exciting. We look forward to providing you updates over the next few quarters. We believe the resources we've raised will enable us to advance multiple potential blockbuster indications in breast and prostate cancer while also aggressively preparing for and potentially launching gedatolisib commercially should we receive FDA approval. Gedatolisib is well positioned to address critical needs in the second-line space with its unique mechanism of action and potential first-in-class and best-in-class safety and efficacy profile.

我們迄今的進展令人鼓舞，也令人振奮。我們期待在接下來的幾個季度向您提供最新進展。我們相信，我們籌集的資源將使我們能夠推進乳腺癌和前列腺癌的多個潛在重磅適應症，同時積極準備並在獲得 FDA 批准後可能將 gedatolisib 推向市場。Gedatolisib 具有獨特的作用機制，以及潛在的同類首創和同類最佳的安全性和有效性，因此在滿足二線治療領域的關鍵需求方面具有良好的優勢。

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

現在我想把電話交給維姬，讓她來審核一下我們的財務狀況。

Thank you, Brian, and good afternoon, everyone. I'll provide a brief overview of our financial results for the third quarter of 2025. Our third-quarter net loss was $43.8 million or $0.92 per share compared to $29.8 million net loss or $0.70 per share for the third quarter of 2024.

謝謝你，布萊恩，大家下午好。我將簡要概述我們2025年第三季的財務表現。我們第三季淨虧損為 4,380 萬美元，即每股虧損 0.92 美元，而 2024 年第三季淨虧損為 2,980 萬美元，即每股虧損 0.70 美元。

Our non-GAAP adjusted net loss was $37.2 million or $0.78 per share for the third quarter of 2025 compared to non-GAAP adjusted net loss of $27.6 million or $0.65 per share for the third quarter of 2024. Research and development expenses were $34.9 million for the third quarter of 2025 compared to $27.6 million for the third quarter of 2024.

2025 年第三季度，我們非 GAAP 調整後的淨虧損為 3,720 萬美元，即每股虧損 0.78 美元，而 2024 年第三季非 GAAP 調整後的淨虧損為 2,760 萬美元，即每股虧損 0.65 美元。2025 年第三季的研發費用為 3,490 萬美元，而 2024 年第三季的研發費用為 2,760 萬美元。

Of the approximately $7.3 million increase in R&D expenses, $5.6 million was related to increased employee and consulting expenses, $3.2 million of which related to commercial headcount additions and other launch activities. The remaining $1.7 million increase was primarily related to activities supporting our ongoing clinical trials.

研發費用增加約 730 萬美元，其中 560 萬美元與員工和諮詢費用增加有關，而這 560 萬美元中又有 320 萬美元與商業人員增加和其他上市活動有關。剩餘的 170 萬美元增長主要與支持我們正在進行的臨床試驗的活動有關。

General and administrative expenses were $7.9 million for the third quarter of 2025 compared to $2.5 million for the third quarter of 2024. Of the approximately $5.4 million increase in G&A expenses, $4.9 million increase was related to increased employee and consulting expenses. Of this increase, $4 million was related to noncash stock-based compensation. The remaining $0.5 million of the $5.4 million increase primarily related to professional fees, expanding infrastructure, and other administrative expenses.

2025 年第三季一般及行政費用為 790 萬美元，而 2024 年第三季為 250 萬美元。在約 540 萬美元的 G&A 費用增加中，490 萬美元的增加與員工和諮詢費用的增加有關。其中，400萬美元與非現金股票補償有關。540萬美元的成長中剩餘的50萬美元主要用於專業費用、擴大基礎設施和其他行政支出。

Net cash used in operating activities for the third quarter of 2025 was $44.8 million compared to $20.6 million for the third quarter of 2024. We ended the quarter with approximately $455 million of cash, cash equivalents, and short-term investments. As Brian mentioned earlier, in July of 2025, we conducted a concurrent public offering of 2.75% convertible senior notes due in 2031 common stock and a prefunded warrant offering. The net proceeds from the combined offerings were $287 million after deducting underwriting discounts, commissions, and the company's operating expenses.

2025 年第三季經營活動所用現金淨額為 4,480 萬美元，而 2024 年第三季為 2,060 萬美元。本季末，我們持有約 4.55 億美元的現金、現金等價物和短期投資。正如布萊恩之前提到的，在 2025 年 7 月，我們同時進行了 2031 年到期的 2.75% 可轉換優先票據、普通股和預付認股權證的公開發行。扣除承銷折扣、佣金和公司營運費用後，合併發行所得淨收益為 2.87 億美元。

In September of 2025, the company entered into an amendment to its existing senior secured term loan facility with an affiliate of Innovatus Capital Partners and Oxford Finance and certain of its affiliates. The amendment increases the total term loan facility size to $500 million, including $350 million in committed capital and up to $150 million at the mutual discretion of Celcuity and its lenders.

2025 年 9 月，該公司與 Innovatus Capital Partners 和 Oxford Finance 的關聯公司及其某些關聯公司簽訂了一份對其現有高級擔保定期貸款安排的修訂協議。該修正案將定期貸款總額增加到 5 億美元，其中包括 3.5 億美元的承諾資本，以及 Celcuity 及其貸款人雙方酌情決定的最高 1.5 億美元。

In connection with the release of the positive top-line data from the PIK3CA wild-type cohort of the VIKTORIA-1 Phase 3 clinical trial, Celcuity achieved the Term D milestone and was eligible to draw an additional $30 million under the term loan facility. In connection with the amendment to the term loan facility, the Term D loan was disbursed and Celcuity received net proceeds of $27.8 million. The upsized facility strengthens Celcuity's ability to manage its capital structure efficiently while providing additional funding to support commercial launch preparations for gedatolisib and other strategic initiatives.

隨著 VIKTORIA-1 3 期臨床試驗中 PIK3CA 野生型隊列的積極頂線數據的發布，Celcuity 達到了 D 期里程碑，並有資格根據定期貸款安排提取額外的 3000 萬美元。與定期貸款安排的修訂有關，定期 D 貸款已發放，Celcuity 獲得了 2780 萬美元的淨收益。擴建後的設施增強了 Celcuity 有效管理其資本結構的能力，同時為支持 gedatolisib 的商業上市準備和其他戰略舉措提供了額外的資金。

Also triggered by the release of the positive top-line data was the 75-day expiration date for warrants that were issued pursuant to a private placement that closed on December 9, 2022. Warrants that were exercised generated cash proceeds of $12.8 million. We expect cash, cash equivalents, investments, and drawdowns on our current debt facility to fund operations through 2027.

正面的業績資料發布也引發了以下事件：根據 2022 年 12 月 9 日完成的私募配售發行的認股權證的 75 天到期日。已行使的認股權證產生了 1280 萬美元的現金收益。我們預計現金、現金等價物、投資以及提取現有債務融資將為營運提供資金，直至 2027 年。

I will now hand the call back to Brian.

現在我將把電話轉回給布萊恩。

Thank you, Vicky. Operator, could you please open the call for questions?

謝謝你，維姬。接線生，請開啟問答環節好嗎？

(Operator Instructions) Maury Raycroft, Jefferies.

（操作說明）莫里‧雷克羅夫特，傑弗里斯。

Hi. Congrats on the progress and thanks for taking my questions. You're planning on having additional data at the San Antonio Breast Cancer Symposium Conference. Maybe talk about what the main focus of the presentation is going to be. And do you anticipate sharing more detailed subpopulation data related to ESR1 wild-type and mutant in the near future?

你好。恭喜你取得進展，謝謝你回答我的問題。您計劃在聖安東尼奧乳癌研討會上提供更多數據。或許可以談談演講的主要內容是什麼。您是否預計在不久的將來分享與 ESR1 野生型和突變型相關的更詳細的亞群數據？

Thanks, Maury. We'll present the data when it's presented. Typically, these presentations that follow the detailed initial presentation include additional subgroup analyses for efficacy, additional data that might relate to certain safety or quality of life aspects of the study. And we expect to follow that approach with the data we released in San Antonio.

謝謝你，莫里。數據公佈後，我們會公佈。通常情況下，在詳細的初步報告之後進行的這些報告包括額外的療效亞組分析，以及可能與研究的某些安全性或生活品質相關的額外數據。我們預計在聖安東尼奧發布的數據中也將採用這種方法。

Okay. Understood. And maybe a question just related to the frontline setting. Wondering if you can comment on whether enrollment in VIKTORIA-2 has been positively impacted by the second-line data. And is there anything additional you can say on timelines? And also wondering if you're considering expanding to first-line endocrine-sensitive patients with the current formulation.

好的。明白了。或許還有一個與前線環境相關的問題。想請您評論一下，VIKTORIA-2 的參保人數是否受到了二線數據的正面影響。關於時間安排，您還有什麼補充說明嗎？我還想知道您是否考慮將目前的配方推廣到第一線內分泌敏感患者。

Thanks for the question. No, enrollment is on track. I mean, certainly, investigators who are participating in the VIKTORIA-2 study were very excited about the results. And I think that, of course, would impact the visibility for their patients and the credibility of the study itself. So we think it will have a favorable effect.

謝謝你的提問。不，招生工作進展順利。我的意思是，參與 VIKTORIA-2 研究的研究人員當然對研究結果感到非常興奮。而我認為這當然會影響患者對研究的關注度以及研究本身的可信度。所以我們認為這將產生有利的影響。

As far as additional Phase 3 studies, I mean, certainly, we have a long-term life cycle development plan. And over time, as we make progress fleshing that out or making some decisions about timing and approach, we'll announce those, but we're not ready to do that yet.

至於其他 3 期研究，我的意思是，當然，我們有一個長期的生命週期開發計劃。隨著時間的推移，當我們完善細節或就時間安排和方法做出一些決定時，我們會公佈這些內容，但我們現在還沒有準備好這樣做。

Got it. Okay, thanks for taking my questions.

知道了。好的，謝謝您回答我的問題。

You're welcome.

不客氣。

Andrew Berens, Leerink Partners.

安德魯貝倫斯，Leerink Partners。

Hi, everyone. This is Amanda on for Andy. So for the real-time oncology review submission process to the FDA, you're guiding to completing that in fourth quarter. We're just kind of trying to figure out the wild-type submission will be complete from the -- completely separate from the mutant submission. Are there any implications to this? Do you also expect the mutant submission to be a real-time oncology review? Any color would be helpful. Thanks.

大家好。這裡是阿曼達替安迪報道。因此，對於向 FDA 提交的即時腫瘤學審查流程，你們的目標是在第四季度完成。我們只是想弄清楚野生型提交是否完整，這與突變體提交完全分開。這會帶來什麼影響？您是否也希望突變體提交能夠進行即時腫瘤學審查？任何顏色都會有幫助。謝謝。

Sure. So we're on track, as I indicated, with the submission for the wild-type cohort completed by the end of this quarter. And we've had specific conversations about the approach that we're taking with this NDA and the RTOR submission and that was ultimately approved by the FDA, reflected that we'll just be submitting and seeking an NDA for the wild-type population. So we're in sync with the FDA on that front.

當然。正如我之前所說，我們正按計劃推進，野生型隊列的提交工作將在本季末完成。我們已經就此次 NDA 和 RTOR 提交所採取的方法進行了具體的討論，最終獲得了 FDA 的批准，這表明我們將只提交和尋求針對野生型群體的 NDA。所以在這方面，我們與FDA的立場是一致的。

We would, depending on the data, request a real-time oncology review for the mutant data, but it's always a function of the data. These real-time reviews are typically only granted when the data is very, very clear and the potential for a new standard of care is possible. And so we hope that's the case. But until we have the data, we can't necessarily commit to that.

根據數據情況，我們會要求對突變數據進行即時腫瘤學審查，但這始終取決於數據。這些即時審查通常只有在數據非常非常清晰，並且有可能形成新的護理標準時才會批准。所以我們希望情況確實如此。但在獲得數據之前，我們不能就此做出承諾。

Got it. Thank you.

知道了。謝謝。

You're welcome.

不客氣。

Tara Bancroft, TD Cowen.

塔拉·班克羅夫特，TD Cowen。

Hi, good afternoon. Thanks for taking the question. So I'm hoping you can maybe expand a bit more on what you believe the eventual duration of therapy will be, especially in the commercial setting for the triplet based on the data that you've seen so far. And then separately, I'm wondering if you could tell us what assumptions would go into your pricing strategy and what are some good comps to look for there. Thanks.

您好，下午好。感謝您回答這個問題。所以我希望您能再詳細闡述您認為最終治療持續時間會是多久，尤其是在商業環境下，根據您目前看到的數據，三胞胎的治療持續時間會是多久。另外，我想單獨問您，您的定價策略是基於哪些假設，以及有哪些好的可比較公司可以參考。謝謝。

Yeah, okay. As far as the duration of therapy, I mean, there's a couple of ways to think about that because there -- we did find variation in the outcomes according to region. And in the US, for instance, we reported that PFS was 19.3 months, which was significantly longer than the intent to treat.

好的。至於治療持續時間，我的意思是，可以從幾個方面來考慮，因為我們確實發現治療結果因地區而異。例如，在美國，我們報告 PFS 為 19.3 個月，明顯長於意圖治療。

And so we have an internal estimate of what we think is reasonable yet. We will do some further analysis before we might share that externally, and that will be a function of providing additional subgroup analyses over the coming months.

因此，我們內部對目前認為合理的方案有初步的估計。在對外分享之前，我們會進行一些進一步的分析，而這取決於未來幾個月內提供的額外亞組分析。

As far as assumptions for pricing, there have been drugs launched recently that are novel therapeutics targeting, in this case, the PI3K pathway. I think the wholesale acquisition cost for one therapeutic or several therapeutics that are in this HR-positive, HER2-negative space are in the range of, let's call it, $25,000, plus or minus.

至於定價假設，最近推出了一些新型治療藥物，其標靶是 PI3K 路徑。我認為，一種或幾種 HR 陽性、HER2 陰性療法的批發採購成本大約在 25,000 美元左右，上下浮動。

And so that's a reasonable benchmark. You also have to factor in potential discounts that would be associated with distribution of the drug. Oral drugs typically will have probably closer to a 30% discount, gross to net of 70% discount.

所以這是一個合理的衡量標準。你還需要考慮與藥品分銷相關的潛在折扣。口服藥物通常可能享受接近 30% 的折扣，總折扣可能達到 70%。

And then medical benefit drugs like geda would probably only have a 20% discount. So you could potentially get a better price in this market just by virtue of being a medical benefit on a net basis with the same wholesale acquisition cost price.

那麼像蓋達這樣的醫療福利藥物可能只能享有 20% 的折扣。因此，僅僅因為醫療福利的淨收益與批發採購成本價格相同，你就有可能在這個市場上獲得更優惠的價格。

Now we're doing research in this area now. We haven't made a final decision on our pricing approach. But for purposes of trying to estimate what the addressable market value is, we think it's reasonable to use the numbers that I just shared.

我們現在正在進行這方面的研究。我們尚未最終確定定價方案。但為了估算潛在市場價值，我們認為使用我剛才分享的數字是合理的。

Great, thank you. That's very helpful.

太好了，謝謝。那很有幫助。

Brad Canino, Guggenheim.

布拉德卡尼諾，古根漢美術館。

Afternoon. Just one question for me. What is the plan to bring gedatolisib to patients outside the US? Thanks.

下午。我只有一個問題。如何將 gedatolisib 帶給美國以外的患者？謝謝。

Sure. I think we've discussed in other calls or at least we've mentioned that we expect to commercialize in the US and as I discussed on the call, and then find a partner or partners to commercialize the drug ex-US. And we are holding off finalizing or really moving forward with intense discussions on that until we have our mutant data available and until we've submitted what we hope is an sNDA for the mutant population.

當然。我想我們已經在其他電話會議中討論過，或者至少提到過，我們希望在美國實現商業化，正如我在電話會議上討論的那樣，然後找到一個或多個合作夥伴，在美國以外地區實現該藥物的商業化。在我們獲得突變體數據並提交我們希望是突變體群體的補充保密協議之前，我們暫緩就此進行最終確定或真正推進深入討論。

And coincident with the submission of the sNDA for the mutant population, if all goes according to plan, we would soon after expect to file an MAA to the European medical authorities that would comprise both mutant and wild-type patient data.

如果一切按計劃進行，在提交突變人群的補充新藥申請 (sNDA) 的同時，我們預計不久後將向歐洲藥品管理局提交上市許可申請 (MAA)，其中將包含突變型和野生型患者數據。

Additionally, we've also been working with the Japanese health authority to identify their requirements for a submission. We think we're aligned with them on an approach that makes sense to us. And so we're moving forward on a regulatory path that will allow us to stay on track with as rapid commercialization as possible, even without the -- rather a marketing partner. And we would expect to start engaging those discussions once, I would say, the middle of next year once our data was available and the regulatory submissions were on their way.

此外，我們也一直在與日本衛生部門合作，以確定他們對提交資料的要求。我們認為我們在方法上與他們保持一致，這種方法對我們來說也是合理的。因此，我們正在朝著監管方向前進，即使沒有行銷合作夥伴，也能讓我們盡可能快速地實現商業化。我預計，一旦我們的數據可用且監管文件正在提交中，我們將在明年年中開始參與這些討論。

Okay, that's clear. Thanks, Brian.

好的，明白了。謝謝你，布萊恩。

You're welcome.

不客氣。

Stephen Willey, Stifel.

Stephen Willey，Stifel。

Hey, can you hear me?

嘿，你聽得到我說話嗎？

We can.

我們可以。

Okay. Hey, This is Dara Azar on for Steve. Brian, you announced plans to develop gedatolisib for endocrine-resistant frontline well before the VIKTORIA-1 readout. I'm curious, has your thinking around the type of frontline population to be enrolled changed at all now that you have Phase 3 data from the wild-type population, you have this interesting signal from Phase 1b subgroup analysis?

好的。大家好，我是Dara Azar，代Steve為您報道。Brian，早在 VIKTORIA-1 試驗結果公佈之前，你就宣布了開發 gedatolisib 用於內分泌抗藥性一線治療的計劃。我很好奇，既然你們現在有了來自野生型人群的 3 期數據，並且從 1b 期亞組分析中得到了這個有趣的信號，你們對於要招募的一線人群類型的想法是否有所改變？

And I'm assuming you have KOL feedback, investor feedback. So what is your philosophical view around the need to conduct endocrine-sensitive trial in the frontline setting? Thank you.

我假設你們有KOL回饋和投資者回饋。那麼，您對在一線環境中進行內分泌敏感性試驗的必要性有何哲學看法？謝謝。

No, thank you for the question. Well, I mean, certainly, we believe that there's an important opportunity to help patients delay their progression for even longer than is possible with the current CDK4/6 letrozole regimens. And we base that view on the data that we obtained in our Phase 1b study in treatment-naive endocrine-sensitive patients.

不，謝謝你的提問。嗯，我的意思是，我們當然相信，這是一個重要的機會，可以幫助患者延緩病情進展，甚至比目前的 CDK4/6 來曲唑療法所能達到的時間更長。我們的觀點是基於我們在 1b 期研究中對未經治療的內分泌敏感患者所獲得的數據。

Now the standard of care CDK4/6 letrozole regimens, the three of them offer patients, at least, as reported in their Phase 3 studies, about 25 months, plus or minus median PFS. In our Phase 1b study, which, again, only 41 patients, single-arm study, so you have to caveat it, but a meaningful enough population that is probably not a random result. But we reported about 48 months median PFS.

目前，CDK4/6 來曲唑治療方案的標準療法，根據其 3 期研究報告，至少可以為患者提供約 25 個月的中位無惡化存活期 (PFS)。在我們的 1b 期研究中，同樣只有 41 名患者，這是一項單臂研究，所以你必須謹慎對待，但這是一個足夠有意義的人群，這可能不是隨機的結果。但我們報告的中位無惡化存活期約為 48 個月。

So that we think helps establish or certainly provide preliminary evidence that this pathway is an important driver in treatment-naive hormone receptor positive breast cancer. And in effect, it kind of confirms our hypothesis certainly helps demonstrate that this pathway, the PAM pathway is really one of three driver pathways promoting breast cancer, the PAM pathway, CDK4/6 and endocrine therapy, or ER pathway.

因此，我們認為這有助於確立或至少提供初步證據，證明該通路是未經治療的荷爾蒙受體陽性乳癌的重要驅動因素。實際上，這在某種程度上證實了我們的假設，也確實有助於證明 PAM 通路確實是促進乳癌的三大驅動通路之一，另外兩個通路是 PAM 通路、CDK4/6 和內分泌治療或 ER 通路。

And so we think there's a very, very strong rationale to develop this drug for that population. It's a long study, given the potential progression-free survival of both the control and study arm and probably a fairly sizable number of patients as well. And so, again, we are wanting to step back, as you suggested, given the results we have here where we really saw a profound effect in wild-type patients and be very thoughtful about how we would design that study in light of the current study in endocrine-resistant patients.

因此，我們認為有非常充分的理由為該族群開發這種藥物。考慮到對照組和研究組的潛在無惡化存活期，以及可能相當多的患者，這是一項長期研究。因此，正如您所建議的，鑑於我們在這裡得到的結果，我們確實看到了對野生型患者的顯著影響，我們再次希望退後一步，認真思考如何根據目前對內分泌抗藥性患者的研究來設計這項研究。

So yes, we believe it's an important opportunity to help patients further. It represents probably two-thirds of women who are treatment-naive in the metastatic setting. And so we think would be an important thing for us to do. And we think there's a lot of strong rationale to do it. And over time, we will provide updates on our thoughts on that.

所以，是的，我們認為這是一個進一步幫助患者的重要機會。這可能代表了轉移性癌症患者中未接受過治療的女性的三分之二。所以我們認為這對我們來說是一件很重要的事。我們認為這樣做有很多充分的理由。我們會不時更新我們對此的看法。

Oliver McCammon, LifeSci.

Oliver McCammon，生命科學。

Thanks for taking my question. I'm just curious if you can speak to the potential impact of a favorable overall survival trend in the second- and third-line setting, caveating that we've seen interim OS data so far. And also curious if you can speak to potentially what role these data could play in the regulatory process as well. Thanks again.

謝謝您回答我的問題。我只是好奇您能否談談在二線和三線治療中，整體生存率呈現良好趨勢的潛在影響，需要說明的是，我們目前看到的只是中期的總體生存率數據。另外，我還想請教一下，這些數據在監管過程中可能扮演什麼角色？再次感謝。

Sure. And so in conjunction with the primary analysis, our stats plan and typically is required, but our stats plan performed an interim OS analysis to demonstrate or hopefully to reveal what, if any, effect you might have on overall survival for these patients.

當然。因此，結合主要分析，我們的統計計劃通常是必需的，但我們的統計計劃進行了中期 OS 分析，以展示或希望揭示您可能對這些患者的總生存期產生的影響（如果有的話）。

The requirement from a regulatory standpoint is that, you don't show any evidence that you're reducing patients' likelihood of survival, i.e., you have to have a hazard ratio that's below one. And in the case of the interim analysis for our study, the hazard ratio was, I think, 0.69 for the triplet and about the same for the doublet, which, again, we believe is a favorable trend. And we think that that supports our submission for drug approval and supportive of that.

從監管角度來看，要求是不能提供任何證據表明你降低了患者的生存幾率，也就是說，你的風險比必須低於 1。就我們研究的中期分析而言，我認為三聯體的風險比為 0.69，雙聯體的風險比也大致相同，我們再次認為這是一個有利的趨勢。我們認為這支持了我們提交的藥物審批申請，並對此表示支持。

As far as the impact of an overall survival positive readout, certainly, we think, impactful. But that's -- it has been a very high bar to beat in second-line setting. There hasn't been a drug yet in the second-line setting that has showed an OS advantage. And that's just because of the nature and heterogeneous nature of the patients and the subsequent drugs they receive. But we'll see.

至於整體存活率陽性結果的影響，我們認為，當然，影響很大。但那——在二線陣容中，這是一個非常高的門檻。目前還沒有一種二線藥物顯示出總存活期優勢。這完全是因為患者的性質和異質性以及他們隨後接受的藥物所致。但我們拭目以待。

I mean, certainly, we look forward to reporting out those numbers. But when you have a study of our size with the sample size, you have a relatively small number of events that you're using to characterize what is only a certain effect size. And so it's a high bar to beat with a small sample size, but we'll see. And certainly, if successful, it will be very impactful.

當然，我們期待著公佈這些數據。但是，對於我們這種規模的研究和樣本量來說，你只有相對較少的事件來描述某種特定的效應量。因此，在樣本量較小的情況下，要達到這個目標難度很高，但我們拭目以待。當然，如果成功，將會產生非常大的影響。

Thanks again.

再次感謝。

Chase Knickerbocker, Craig-Hallum.

蔡斯·尼克博克，克雷格-哈勒姆。

Hi, guys. Thanks for taking the questions. This is Jake on for Chase. In light of this administration's focus on domestic manufacturing, could you just remind us where geda is manufactured?

嗨，大家好。謝謝您回答問題。這是傑克替蔡斯報道。鑑於本屆政府重視國內製造業，您能否提醒我們一下，geda是在哪裡生產的？

Sure. We have several sites for manufacturing, and we have an approach that we think allows us to have flexibility in how we manufacture, where we manufacture the drug. We haven't really announced where we're manufacturing the drug. But based on our kind of inventory approach and also our approach to finding second sources, we're basically taking the steps necessary to make sure our supply chain is as bulletproof as you can make it.

當然。我們擁有多個生產基地，我們採取的方法讓我們能夠在生產方式和生產地點方面擁有更大的靈活性。我們還沒有正式公佈藥品的生產地點。但根據我們的庫存管理方法以及尋找第二貨源的方法，我們基本上正在採取必要的措施，以確保我們的供應鏈盡可能萬無一失。

Great. Thank you.

偉大的。謝謝。

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

目前沒有其他問題了。我想把電話轉回給布萊恩·沙利文，請他做總結發言。先生，請繼續。

Well, thank you for attending our call, and I look forward to providing further updates in the future. Good-bye.

感謝您參加我們的電話會議，我期待在未來為您提供更多最新資訊。再見。

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了。