FibroGen Inc (FGEN) 2025 Q3 法說會逐字稿

Hello and thank you for standing by. Welcome to FibroGen's third-quarter 2025 earnings conference call.

您好，感謝您的耐心等待。歡迎參加 FibroGen 2025 年第三季財報電話會議。

(Operator Instructions)

（操作說明）

I would now like to hand the conference over to Gaia Shamis. You may begin.

現在我將把會議交給蓋亞·沙米斯。你可以開始了。

Thank you, [Tawanda]. Good afternoon, everyone. Thank you for joining us today to discuss FibroGen's third-quarter 2025 financial and business results.

謝謝你，[塔萬達]大家下午好。感謝您今天與我們一起討論 FibroGen 2025 年第三季的財務和業務業績。

I'm Gaia Shamis from LifeSci Advisors. Joining me on today's call are Thane Wettig, Chief Executive Officer; and David DeLucia, Chief Financial Officer.

我是來自 LifeSci Advisors 的 Gaia Shamis。今天與我一起參加電話會議的有執行長 Thane Wettig 和財務長 David DeLucia。

Following the prepared remarks, we will open the call to your questions.

在發言結束後，我們將開放提問環節。

I would like to remind you that remarks made on today's call include forward-looking statements about FibroGen. Such statements may include, but are not limited to, collaboration with AstraZeneca and Astellas; financial guidance; the initiation, enrollment, design, conduct, and results of clinical trials; regulatory strategies and potential regulatory results; research and development activities; commercial results and results of operations; risks related to our business; and certain other business matters.

我想提醒各位，今天電話會議上發表的言論包含有關 FibroGen 的前瞻性陳述。此類聲明可能包括但不限於：與阿斯特捷利康和安斯泰來公司的合作；財務指導；臨床試驗的啟動、招募、設計、實施和結果；監管策略和潛在的監管結果；研發活動；商業成果和經營成果；與我們業務相關的風險；以及某些其他商業事項。

Each forward-looking statement is subject to risks and uncertainties that could cause actual results and events to differ materially from those projected in that statement.

每項前瞻性聲明都存在風險和不確定性，可能導致實際結果和事件與該聲明中預測的結果和事件有重大差異。

A more complete description of these and other materials risks can be found in FibroGen's filing with the SEC, including our most recent Form 10-K and Form 10-Q.

有關這些及其他重大風險的更完整描述，請參閱 FibroGen 向美國證券交易委員會提交的文件，包括我們最新的 10-K 表格和 10-Q 表格。

FibroGen does not undertake any obligation to update publicly any forward-looking statements, whether as a result of new information, future events, or otherwise.

FibroGen 不承擔任何公開更新任何前瞻性聲明的義務，無論是由於新資訊、未來事件或其他原因。

The press release reporting the company's financial results and business updates and a webcast of today's conference call can be found on the Investors section of FibroGen's website at www.fibrogen.com.

報告公司財務表現和業務更新的新聞稿以及今天電話會議的網路直播可以在 FibroGen 網站 www.fibrogen.com 的投資者關係部分找到。

With that, I would like to turn the call over to CEO, Thane Wettig. Thane?

接下來，我將把電話交給執行長 Thane Wettig。領主？

Thank you, Gaia. Good afternoon, everyone. Welcome to our third quarter of 2025 earnings call.

感謝蓋亞。大家下午好。歡迎參加我們2025年第三季財報電話會議。

On today's call, I will provide an update on our ongoing efforts, with a focus on our three main priorities: the completion of the sale of FibroGen China; the continued progress with our lead asset, FG-3246, a potential first-in-class antibody drug conjugate targeting CD46, and its companion PET imaging agent in metastatic castration-resistant prostate cancer; and the path forward for Roxadustat as a potential treatment for anemia due to lower-risk myelodysplastic syndromes.

在今天的電話會議上，我將報告我們正在進行的工作，重點介紹我們的三個主要優先事項：完成對 FibroGen China 的出售；繼續推進我們的主導資產 FG-3246（一種潛在的首創抗體藥物偶聯物，靶向 CD46）及其配套 PET 成像劑在轉移性去勢抵抗性前列腺癌中的應用貧血症以及 Roxastat 作為健康疾病的異常治療的潛在疾病進展；

Then, David DeLucia, our CFO, will review the financials. After which, we will open the call for your questions.

然後，我們的財務長大衛·德盧西亞將審核財務報表。之後，我們將開放提問環節。

On slide 3, I would like to start with the sale of FibroGen China to AstraZeneca that we recently completed for approximately $220 million. This was a truly transformative transaction that provided us with the most efficient means to access the company's cash held in China, extending our cash runway into 2028. Following the transaction, we successfully paid off the term loan facility with Morgan Stanley tactical value.

在第 3 張投影片中，我想先談談我們最近以約 2.2 億美元的價格將 FibroGen China 出售給阿斯特捷利康的交易。這是一筆真正具有變革意義的交易，它為我們提供了獲取公司在中國持有的現金的最有效途徑，使我們的現金儲備能夠維持到 2028 年。交易完成後，我們利用摩根士丹利的戰術價值成功償還了定期貸款。

Second, we continued to progress FG-3246 and FG-3180 in metastatic castration-resistant prostate cancer, or mCRPC; and initiated the Phase 2 monotherapy trial of FG-3246 and FG-3180 earlier this quarter. Additionally, we expect the top-line results from the investigator-sponsored trial of FG-3246 in combination with enzalutamide in mCRPC to be presented at a medical conference in the first quarter of 2026.

其次，我們繼續推進 FG-3246 和 FG-3180 在轉移性去勢抵抗性前列腺癌 (mCRPC) 中的應用；並在本季度早些時候啟動了 FG-3246 和 FG-3180 的 2 期單藥治療試驗。此外，我們預計由研究者發起的 FG-3246 與恩扎盧胺聯合治療 mCRPC 的試驗的主要結果將於 2026 年第一季在醫學會議上公佈。

Third, as we have previously stated, we had a successful Type C meeting with the FDA in July, providing us with a clear regulatory path forward for Roxadustat. We remain on track to submit the Phase 3 trial protocol for Roxadustat for the treatment of lower-risk myelodysplastic syndromes in patients with high-transfusion burden later this quarter.

第三，正如我們之前所述，我們在 7 月與 FDA 成功舉行了 C 類會議，為 Roxadustat 的監管發展提供了明確的途徑。我們仍按計畫於本季稍後提交羅沙司他治療輸血負擔重的低風險骨髓增生異常症候群患者的 3 期試驗方案。

We are confident that with our mid- and late-stage assets, simplified capital structure, and upcoming near-term catalysts across both clinical programs, we are well positioned to advance meaningful therapeutic options for patients and significant value for shareholders.

我們相信，憑藉其中後期資產、簡化的資本結構以及兩個臨床項目即將出現的近期催化劑，我們有能力為患者推進有意義的治療方案，並為股東創造重大價值。

I will now provide a brief overview of our FG-3246 and FG-3180 programs in mCRPC.

現在我將簡要概述我們在 mCRPC 中的 FG-3246 和 FG-3180 專案。

Slide 5 summarizes the high unmet need in late-stage prostate cancer. Approximately 290,000 men are diagnosed with prostate cancer each year in the US, with about 65,000 drug-treatable patients where the cancer has metastasized and become castrate-resistant. This group of patients has a grim five-year survival rate of approximately 30%, underscoring the significant opportunity for new life-extending treatments.

投影片 5 總結了晚期前列腺癌患者未滿足的巨大需求。美國每年約有 29 萬名男性被診斷出患有前列腺癌，其中約有 6.5 萬名患者雖然可以透過藥物治療治愈，但癌症已經轉移並產生了去勢抵抗性。這群患者的五年存活率僅為 30% 左右，凸顯了開發新的延長生命療法的巨大機會。

We believe that FG-3246 could be this new treatment option and estimate the total addressable market to be well over $5 billion, annually.

我們相信 FG-3246 可能是一種新的治療選擇，並估計其潛在市場規模每年將超過 50 億美元。

On slide 6, we highlight the novelty of CD46, a tumor-selective target that has several distinguishing features.

在第 6 張投影片中，我們重點介紹了 CD46 的新穎性，CD46 是一種腫瘤選擇性靶點，具有幾個顯著特徵。

First, CD46 is upregulated during tumorigenesis and helps tumors evade complement-dependent cytotoxicity.

首先，CD46 在腫瘤發生過程中上調，幫助腫瘤逃避補體依賴性細胞毒性。

Second, its expression is also upregulated in the progression from localized castration-sensitive prostate cancer to metastatic castration-resistant prostate cancer; and further overexpressed, following treatment with androgen-signaling inhibitors.

其次，在從局部去勢敏感性前列腺癌發展為轉移性去勢抵抗性前列腺癌的過程中，其表達也上調；並且在接受雄激素信號抑製劑治療後，進一步過度表達。

Notably, CD46 is highly expressed in mCRPC tissues with lower interpatient variability and higher median expression compared with PSMA, making it an attractive therapeutic target.

值得注意的是，與 PSMA 相比，CD46 在 mCRPC 組織中高表達，患者間變異性較低，中位表達量較高，使其成為一個有吸引力的治療標靶。

Turning to slide 7, FG-3246 is our potential first-in-class ADC in development for mCRPC. The ADC combines the YS5 antibody with an MMAE payload to specifically target the tumor-selective epitope of CD46. YS5 is a fully human IgG1 monoclonal antibody that was engineered to specifically target the tumor-selective epitope of CD46, whose expression is limited in normal tissue.

翻到第 7 張投影片，FG-3246 是我們正在開發的用於治療 mCRPC 的潛在首創 ADC。此 ADC 將 YS5 抗體與 MMAE 有效載荷結合，以特異性靶向 CD46 的腫瘤選擇性表位。YS5 是一種全人源 IgG1 單株抗體，經過基因工程改造，可特異性靶向 CD46 的腫瘤選擇性表位，該表位在正常組織中的表現有限。

FG-3246 represents an androgen receptor-agnostic approach, clinically differentiating it from other prostate cancer treatments currently in development, many of which target PSMA.

FG-3246 代表了一種不依賴雄激素受體的方法，這在臨床上使其與其他正在開發的、以 PSMA 為標靶的前列腺癌治療方法有所區別。

The companion PET imaging agent, FG-3180, utilizes the same YS5-targeting antibody as FG -3246; and is also under clinical development.

伴隨的 PET 造影劑 FG-3180 使用了與 FG-3246 相同的 YS5 靶向抗體；目前也正在進行臨床開發。

We believe that having a patient selection biomarker would not only allow us to better enrich the patient population in a future Phase 3 trial, it could also enable differentiation of FG-3246 in the prostate cancer treatment paradigm.

我們相信，擁有患者選擇生物標記不僅可以讓我們在未來的 3 期試驗中更好地豐富患者群體，還可以使 FG-3246 在前列腺癌治療模式中脫穎而出。

In addition, FG-3180 could represent an important commercial opportunity as a companion diagnostic to FG-3246, similar to the existing PSMA PET agents.

此外，FG-3180 可能代表一個重要的商業機會，可以作為 FG-3246 的伴隨診斷試劑，類似於現有的 PSMA PET 試劑。

Slide 8 recaps the top-line results from the two FG-3246 clinical trials to date.

第 8 張投影片總結了迄今為止兩項 FG-3246 臨床試驗的主要結果。

On the left side, we highlight the Phase 1 monotherapy study where a median radiographic progression-free survival of 8.7 months was observed in patients with mCRPC that were heavily pre-treated and were not biomarker selected. PSA reductions of greater than 50% were achieved in 36% of these patients.

在左側，我們將重點放在 1 期單一藥物治療研究，該研究觀察到，對於接受大量預先治療且未透過生物標記選擇的 mCRPC 患者，中位放射學無惡化存活期為 8.7 個月。36% 的患者 PSA 值降低了 50% 以上。

On the right, we highlight the previously reported preliminary efficacy data from the Phase 1b portion of the investigator-sponsored combination study with enzalutamide, which demonstrated a preliminary estimate of 10.2 months of radiographic progression-free survival, with PSA declines observed in 71% of [evaluable] patients.

在右側，我們重點介紹了先前報告的由研究者發起的恩扎盧胺聯合治療研究的 1b 期部分初步療效數據，該數據初步估計放射學無進展生存期為 10.2 個月，在 71% 的[可評估的]患者中觀察到 PSA 下降。

The top-line results from the IST are expected to be presented at a medical conference in the first quarter of 2026.

IST 的主要研究結果預計將於 2026 年第一季在醫學會議上公佈。

Together, these results highlight what we believe is compelling clinical activity with FG-3246, with competitive rPFS results compared to other approved and investigational treatments in both the monotherapy and combination settings.

這些結果共同突顯了我們認為 FG-3246 具有令人信服的臨床活性，在單藥治療和聯合治療方面，其 rPFS 結果與其他已批准和正在研究的療法相比具有競爭力。

Moving to slide 9, based on the Phase 1 monotherapy results, we initiated the FG-3246 Phase 2 monotherapy dose-optimization trial in September. We plan to enroll 75 patients in the post-ARPI/pre-chemo setting across three dose levels to determine the optimal dose for Phase 3, based on efficacy, safety, and PK parameters.

翻到第 9 張投影片，根據 1 期單藥治療結果，我們在 9 月啟動了 FG-3246 2 期單藥治療劑量優化試驗。我們計劃在 ARPI 治療後/化療前階段招募 75 名患者，分為三個劑量水平，以根據療效、安全性和藥物動力學參數確定 3 期試驗的最佳劑量。

It is important to note that FG-3180 will be an integral part of the study, as we seek to demonstrate the correlation between CD46 expression and response to the ADC in this all-comers population.

值得注意的是，FG-3180 將是該研究的重要組成部分，因為我們試圖證明 CD46 表達與該所有人群對 ADC 的反應之間的相關性。

One other important design element is the use of G-CSF as primary prophylaxis to mitigate Grade 3 or greater neutropenia commonly seen with MMAE payloads and also experienced in the Phase 1 monotherapy trial. The addition of G-CSF is designed to reduce dose interruptions and downward adjustments and may enable a better tolerated and more consistent treatment with the ADC.

另一個重要的設計要素是使用 G-CSF 作為一級預防措施，以減輕 MMAE 有效載荷常見的 3 級或更高級別的中性粒細胞減少症，這種中性粒細胞減少症在 1 期單藥治療試驗中也有所發生。添加 G-CSF 旨在減少劑量中斷和劑量下調，並可能使 ADC 治療具有更好的耐受性和更穩定的療效。

An interim analysis of the Phase 2 trial is planned for the second half of 2026 and will include efficacy, safety, PK, and exposure response data that will be reported as they become available, given the open-label design of the trial.

計劃於 2026 年下半年對 2 期試驗進行中期分析，分析內容將包括療效、安全性、藥物動力學和暴露反應數據，鑑於該試驗採用開放標籤設計，這些數據將在獲得後立即公佈。

On slide 10, I'd like to highlight three important steps we have taken with the design of the Phase 2 monotherapy trial, with the aim of building on the 8.7 months of rPFS demonstrated in the Phase 1 monotherapy trial.

在第 10 張投影片中，我想重點介紹我們在 2 期單藥治療試驗設計中採取的三個重要步驟，目的是在 1 期單藥治療試驗中證明的 8.7 個月 rPFS 的基礎上繼續發展。

First, leveraging the preliminary evidence of an exposure-response relationship, the Phase 2 study will use three of the highest doses from the Phase 1 dose escalation and expansion study.

首先，利用暴露-反應關係的初步證據，2 期研究將採用第 1 期劑量遞增和擴展研究中最高的三個劑量。

Second, primary prophylaxis with G-CSF will be utilized to potentially mitigate neutropenia, which could enable more consistent exposure to the ADC, with fewer dose interruptions or adjustments early in the course of treatment. This could consequently extend the duration of the therapy and potentially enhance the efficacy of the ADC.

其次，將採用 G-CSF 進行一級預防，以減輕中性粒細胞減少症，從而能夠更穩定地暴露於 ADC，減少治療早期劑量中斷或調整。因此，這可能會延長治療持續時間，並有可能提高 ADC 的療效。

Third, enrolling healthier patients in earlier lines of therapy versus the five median lines of therapy in the Phase 1 trial.

第三，與第 1 期試驗中平均接受 5 線治療的患者相比，本研究納入了更健康的患者，並讓他們接受更早期的治療。

Together, we believe that these design elements have the potential to improve upon the Phase 1 results and achieve an rPFS of 10 months or greater, which we believe is the benchmark for commercial competitiveness.

我們相信，這些設計要素共同作用，有可能改善第一階段的結果，並實現 10 個月或更長的 rPFS，我們認為這是商業競爭力的基準。

Slide 11 shows our long-term development strategy for FG-3246 and FG-3180, which provides us with important optionality in prostate cancer. We have a well-designed Phase 2 monotherapy trial in the post-ARPI/pre-chemo setting in mCRPC to attempt to further build upon the 8.7 months of rPFS demonstrated in the Phase 1 monotherapy study.

第 11 張幻燈片展示了我們針對 FG-3246 和 FG-3180 的長期發展策略，這為我們在前列腺癌治療方面提供了重要的選擇。我們正在進行一項精心設計的 2 期單藥治療試驗，該試驗針對的是接受 ARPI 治療後/化療前的 mCRPC 患者，旨在進一步提高 1 期單藥治療研究中顯示的 8.7 個月的 rPFS。

In addition, the Phase 2 study will explore the correlation between CD46 expression and response to the ADC, potentially validating FG-3180 as a predictive patient selection biomarker in future studies.

此外，2 期研究將探討 CD46 表現與 ADC 反應之間的相關性，從而在未來的研究中驗證 FG-3180 作為預測患者選擇的生物標記。

We are confident that our development pathway for FG-3246 unlocks sequential or parallel registrational pathways, as FG-3246 will be evaluated in multiple lines of therapy, in monotherapy and/or in combination with an ARPI and in an all-comers population or patients with high expression of CD46.

我們相信，FG-3246 的開發途徑能夠開啟順序或併行的註冊途徑，因為 FG-3246 將在多種治療方案中進行評估，包括單藥治療和/或與 ARPI 聯合治療，以及在所有人群或 CD46 高表達患者中進行評估。

Slide 12 highlights the recent and upcoming catalysts for the FG-3246 in the FG-3180 program.

第 12 張投影片重點介紹了 FG-3180 計畫中 FG-3246 的近期和即將推出的催化劑。

Looking ahead, we expect the top-line results from the IST of FG-3246 in combination with enzalutamide to be presented at a medical conference in the first quarter of 2026. With the recent initiation of the Phase 2 monotherapy trial, we expect to report the interim results in the second half of 2026.

展望未來，我們預計 FG-3246 與恩扎盧胺聯合用藥的 IST 的主要結果將於 2026 年第一季在醫學會議上公佈。隨著 2 期單藥治療試驗的啟動，我們預計將於 2026 年下半年公佈中期結果。

To summarize, on slide 13, FG-3246 targets a novel epitope on prostate cancer cells with first-in-class potential, given there are no other CD46 targeted projects in clinical development. Targeting CD46 with FG-3246 has already demonstrated promising early efficacy signals with an acceptable safety profile, both in monotherapy and combination settings.

綜上所述，在第 13 張幻燈片中，FG-3246 靶向前列腺癌細胞上的一個新表位，具有首創潛力，因為目前還沒有其他 CD46 靶向項目處於臨床開發階段。靶向 CD46 的 FG-3246 已顯示出令人鼓舞的早期療效信號，並且在單藥治療和聯合治療中均具有可接受的安全性。

We are excited for the upcoming milestones and look forward to updating you as the program progresses.

我們對即將到來的里程碑感到興奮，並期待隨著專案的進展向您報告最新情況。

Turning now to Roxadustat, slide 15 highlights the unmet need and the potential for Roxadustat in the approximately 49,000 patients with anemia associated with lower-risk MDS in the US alone.

現在來看羅沙司他，第 15 張投影片重點介紹了羅沙司他在美國約 49,000 名患有低危險 MDS 相關貧血的患者中尚未滿足的需求和潛力。

Current treatments are effective in less than 50% of patients. With no oral options currently on the market or in late-stage development, a significant opportunity exists to offer a potential new treatment that is durable, with convenient oral administration to patients in the second-line and beyond setting.

目前的治療方法對少於50%的患者有效。由於目前市面上沒有口服治療方案，也沒有處於後期研發階段的口服治療方案，因此存在著一個重要的機會，可以為二線及以後的治療患者提供一種持久有效的、方便口服的潛在新療法。

Moving to slide 16, I would like to briefly highlight the data from a post-hoc analysis in a subgroup of patients with anemia of lower-risk MDS who entered the Phase 3 MATTERHORN study of Roxadustat with a high-transfusion burden.

接下來是第 16 張投影片，我想簡要地重點介紹一項事後分析的數據，該分析針對的是一組患有低風險 MDS 貧血的患者，他們在 Roxadustat 的 3 期 MATTERHORN 研究中接受了高輸血負擔治療。

In this analysis, using the International Working Group definition for high-transfusion burden of four or more RBC units in two consecutive eight-week periods, Roxadustat showed a meaningful treatment effect, with 36% of patients achieving transfusion independence for greater than or equal to eight weeks versus only 7% in the placebo group with a nominal p-value of 0.041. These results are highly similar to the pivotal trial results for the two most recently approved therapies for anemia associated with lower-risk MDS.

在本分析中，根據國際工作小組對高輸血負擔的定義（即連續兩個八週內輸註四單位或以上紅血球），羅沙司他顯示出顯著的治療效果，36%的患者實現了八週或以上的輸血獨立，而安慰劑組僅為7%（名義p值為0.041）。這些結果與最近核准的兩種用於治療低危險性MDS相關貧血的關鍵性試驗結果高度相似。

Based on these results, as we turn to slide 17, our target indication for Roxadustat is in patients with lower MDS and high-transfusion burden who are refractory to or ineligible for prior ESA treatment, where we believe Roxadustat has the potential to elevate the standard of care in the second-line and beyond treatment settings.

基於這些結果，正如我們在第 17 張幻燈片中所述，我們對 Roxadustat 的目標適應症是 MDS 程度較低且輸血負擔較重的患者，這些患者對先前的 ESA 治療無效或不適合接受 ESA 治療，我們相信 Roxadustat 有潛力提高二線及以後治療的標準潛力。

In July, we had a positive Type C meeting with the FDA, where we aligned on key design elements and a regulatory path forward for Roxadustat.

7 月，我們與 FDA 舉行了一次積極的 C 類會議，會上我們與 Roxadustat 的關鍵設計要素和監管路徑達成了一致。

The potential pivotal Phase 3 trial, summarized on slide 18, will include patients requiring four or more RBC units in two consecutive eight-week periods prior to randomization who, as I alluded to on the previous slide, are refractory to, intolerant to, or ineligible for prior ESAs.

在投影片 18 中總結的潛在關鍵性 3 期試驗將包括隨機分組前連續兩個八週內需要 4 個或更多 RBC 單位的患者，正如我在上一張幻燈片中提到的，這些患者對先前的 ESA 治療無效、不耐受或不符合治療條件。

We also agreed with the FDA on important dosing elements, including the starting dose of 2.5 milligrams per kilogram; and on the management of potential thrombotic risk, which could include trial eligibility, dose modification, and discontinuation criteria. We are currently evaluating 8-week and 16-week RBC-transfusion independence as the primary endpoint for the trial.

我們也與 FDA 就重要的劑量要素達成一致，包括每公斤體重 2.5 毫克的起始劑量；以及對潛在血栓風險的管理，其中可能包括試驗資格、劑量調整和停藥標準。我們目前正在評估 8 週和 16 週的紅血球輸注獨立性作為試驗的主要終點。

The team continues to work diligently on finalizing the Phase 3 protocol. We remain on course for submission in the fourth quarter of this year. We are currently exploring our clinical development options, which include maintaining Roxadustat as a wholly owned asset and running the Phase 3 trial on our own or partnering the program. We are actively engaged in this process and will ultimately choose the path that we believe is in the best interest of our shareholders.

團隊正持續努力完善第三階段試驗方案。我們仍按計劃將於今年第四季提交報告。我們目前正在探索臨床開發方案，包括將 Roxadustat 作為完全擁有的資產，自行進行 3 期試驗，或與他人合作進行此計畫。我們正在積極參與這個過程，並最終選擇我們認為最符合股東利益的道路。

To summarize, on slide 19, there is significant opportunity for Roxadustat in anemia associated with lower-risk MDS, with no other oral treatments currently available or in late-stage development.

綜上所述，在第 19 張投影片中，羅沙司他對於與低危險 MDS 相關的貧血具有重要意義，目前尚無其他口服治療方法，也沒有其他治療方法處於後期研發階段。

Furthermore, we believe our target indication would support an orphan-drug designation which, if granted, would provide us with seven years of data exclusivity in the US. This potential exclusivity, combined with an attractive market opportunity and an efficient commercial model, represents a substantial economic opportunity for Roxadustat in anemia associated with lower-risk MDS.

此外，我們相信我們的目標適應症將支持孤兒藥資格認定，如果獲得認定，我們將在美國獲得七年的數據獨佔權。這種潛在的獨家性，加上有吸引力的市場機會和高效的商業模式，代表著羅沙司他治療低危險 MDS 相關貧血的巨大經濟機會。

With that, I will now turn the call over to Dave to discuss the company's financials. Dave?

接下來，我會把電話交給戴夫，讓他來討論公司的財務狀況。戴夫？

Thank you, Thane.

謝謝你，泰恩。

I will first review the updated FibroGen China transaction details; and then, provide the company's financial performance for the third quarter of 2025.

我將首先回顧更新的 FibroGen 中國交易詳情；然後，提供該公司 2025 年第三季的財務表現。

As a reminder: Our China operations are reflected as discontinued operations throughout our financials.

再次提醒：我們財務報表中已將中國業務列為終止經營業務。

On slide 21, we highlight the summary of the key financial terms of the transaction.

在第 21 張投影片中，我們重點概述了交易的關鍵財務條款。

Upon the close of the transaction in August 2025, FibroGen received an enterprise value of $85 million plus FibroGen net cash held in China at closing of approximately $135 million, with a total consideration of approximately $220 million. This is a $60 million increase from our initial net cash guidance in February.

2025 年 8 月交易完成後，FibroGen 獲得 8,500 萬美元的企業價值，加上 FibroGen 在交易完成時在中國持有的約 1.35 億美元的淨現金，總對價約為 2.2 億美元。這比我們2月的初步淨現金預期增加了6000萬美元。

Upon close of the China transaction, we paid off our senior secured term loan with Morgan Stanley Tactical Value, resulting in a cash outflow of approximately $80.9 million. This includes the $75 million principal balance, accrued and unpaid interest, and an applicable pre-payment penalty.

中國交易完成後，我們償還了摩根士丹利戰術價值公司的優先擔保定期貸款，導致約 8,090 萬美元的現金流出。這包括 7,500 萬美元的本金餘額、應計未付利息以及適用的提前還款罰金。

The net cash payable at closing is subject to holdbacks of $10 million, which is comprised of a $6 million holdback to offset final net cash adjustments and a $4 million holdback to satisfy any indemnity claims.

交割時應付淨現金需預留 1,000 萬美元，其中包括 600 萬美元用於抵銷最終淨現金調整，以及 400 萬美元用於滿足任何賠償要求。

I am happy to announce that we have received $6.4 million associated with the first holdback last week. We expect to receive the second holdback of $4 million in the second quarter of 2026.

我很高興地宣布，我們已收到上週第一筆預留款項相關的 640 萬美元。我們預計將於 2026 年第二季收到第二筆預留款項 400 萬美元。

This truly transformative transaction allowed us to pay down our senior term loan facility with MSTV, provided full access to our cash in China, and extended the company's runway into 2028 to support US development initiatives.

這項真正具有變革意義的交易使我們能夠償還MSTV的高級定期貸款，讓我們能夠完全動用在中國的現金，並將公司的營運期限延長至2028年，以支持美國的發展計畫。

Given the company's current market capitalization of approximately $45 million, we believe these increases in expected net cash received upon the close of the transaction represent a meaningful outcome for shareholders.

鑑於該公司目前的市值約為 4500 萬美元，我們認為交易完成後預期收到的淨現金增加，對股東而言是一個有意義的結果。

Now, on to the company's financials for the third quarter.

接下來，我們來看看公司第三季的財務數據。

For the third quarter of 2025, total revenue was $1.1 million compared to $0.1 million for the same period in 2024. For full-year 2025, we reiterate total revenues to be between $6 million and $8 million dollars.

2025 年第三季總營收為 110 萬美元，而 2024 年同期為 10 萬美元。對於 2025 年全年，我們重申總收入將在 600 萬美元至 800 萬美元之間。

Now, moving down the income statement, total operating costs and expenses for the third quarter of 2025 were $6.5 million compared to $47.8 million for the third quarter of 2024, a decrease of $41.3 million or 86% year over year. R&D expenses for the third quarter of 2025 were $1.2 million compared to $20 million in the third quarter of 2024, a decrease of $18.8 million or 94% year over year. SG&A expenses for the third quarter of 2025 were $5.3 million compared to $9.4 million in the third quarter of 2024, a decrease of $4.1 million or 43% year over year.

現在，我們來看看損益表，2025 年第三季的總營運成本和費用為 650 萬美元，而 2024 年第三季為 4,780 萬美元，年比減少了 4,130 萬美元，降幅達 86%。2025 年第三季的研發費用為 120 萬美元，而 2024 年第三季為 2,000 萬美元，年減了 1,880 萬美元，降幅達 94%。2025 年第三季的銷售、一般及行政費用為 530 萬美元，而 2024 年第三季為 940 萬美元，年比減少了 410 萬美元，降幅達 43%。

During the third quarter of 2025, we recorded a net loss from continuing operations of $13.1 million or $3.25 net loss per basic and diluted share, as compared to a net loss of $48.3 million or $12.01 per basic and diluted share for the third quarter of 2024.

2025 年第三季度，我們錄得持續經營業務淨虧損 1,310 萬美元，即每股基本及攤薄虧損 3.25 美元，而 2024 年第三季淨虧損為 4,830 萬美元，即每股基本及攤薄虧損 12.01 美元。

For full-year 2025, we are updating our guidance for our total operating costs and expenses, including stock-based compensation, to be between $50 million and $60 million dollars. At the midpoint, this represents a 70% reduction from full-year 2024.

對於 2025 年全年，我們將總營運成本和費用（包括股票選擇權費用）的預期更新為 5,000 萬美元至 6,000 萬美元。中點數值比 2024 年全年減少了 70%。

Now, shifting towards cash, as of September 30, we reported $121.1 million in cash, cash equivalents, accounts receivable, and investments in the US. We expect the company to now have cash runway into 2028.

現在，讓我們來看看現金，截至 9 月 30 日，我們報告在美國擁有 1.211 億美元的現金、現金等價物、應收帳款和投資。我們預計該公司目前的現金流足以支撐到 2028 年。

In summary, we believe we have taken important steps to reduce our fixed cost infrastructure across both project and FTE spend to maximize our cash runway and enable investment in our US pipeline opportunities.

總而言之，我們相信我們已經採取了重要措施來降低專案和 FTE 支出方面的固定成本基礎設施，從而最大限度地延長我們的現金儲備，並使我們能夠投資於我們在美國的專案機會。

Thank you. I will now turn the call back over to Thane.

謝謝。現在我將把通話轉回給塔恩。

Thank you, Dave.

謝謝你，戴夫。

To conclude today's remarks, with a substantially strengthened financial position and an extended cash runway through multiple clinical milestones into 2028, we are well positioned to advance our mid- and late-stage clinical development programs for FG-3246 and Roxadustat, respectively.

最後總結一下今天的發言，憑藉大幅增強的財務狀況和持續到 2028 年的多個臨床里程碑的現金儲備，我們完全有能力推進 FG-3246 和 Roxadustat 的中期和後期臨床開發項目。

We look forward to reporting the top-line results from the investigator-sponsored study of FG-3246 in combination with enzalutamide at a medical conference in the first quarter of 2026. The recently initiated Phase 2 monotherapy trial of FG-3246 is progressing as planned and we expect to report the interim results in the second half of 2026.

我們期待在 2026 年第一季的醫學會議上報告由研究者發起的 FG-3246 與恩扎盧胺聯合用藥研究的主要結果。最近啟動的 FG-3246 2 期單藥治療試驗正在按計劃進行，我們預計將於 2026 年下半年公佈中期結果。

Finally, with the positive feedback received from the FDA, we now have a regulatory path forward to advanced Roxadustat for the treatment of anemia associated with lower-risk MDS. We'll submit the pivotal Phase 3 protocol before the end of this year.

最後，在收到 FDA 的正面回饋後，我們現在有了一條監管途徑，可以推進 Roxadustat 的研發，用於治療與低風險 MDS 相關的貧血。我們將在今年底前提交關鍵的第三階段試驗方案。

We have made substantial progress this year transforming FibroGen into a lean and laser -focused organization, firmly positioning us to finish this year on a high note with an exciting future ahead.

今年，我們在將 FibroGen 轉型為精簡高效、目標明確的組織方面取得了實質進展，這使我們能夠以優異的成績結束今年，並擁有一個令人興奮的未來。

We look forward to providing further updates to our stakeholders over the coming months.

我們期待在未來幾個月內向利害關係人提供更多最新資訊。

I would now like to turn the call over to the operator for Q&A.

現在我想把電話轉交給接線生進行問答環節。

Thank you.

謝謝。

(Operator Instructions)

（操作說明）

Andy Hsieh, William Blair.

謝家華，威廉布萊爾。

Yeah. Thanks for taking our question. Congratulations on closing that [$220 million] deal with AstraZeneca. Just really transformative for the company.

是的。感謝您回答我們的問題。恭喜你們與阿斯特捷利康達成價值 2.2 億美元的交易。這對公司來說真是一次意義非凡的變革。

We have three questions across the pipeline program.

我們對整個人才培育計畫有三個問題。

One is on the Roxadustat-MDS pivotal trial. You mentioned about the potential thrombotic risk, very prudent thing to incorporate into the trial. But I'm just curious, maybe from an epidemiology perspective, in that second-line or later setting, refractory, intolerable to ESAs, what proportion of patients do you think might be screened out because of the thrombotic risk?

其中一位參與了 Roxadustat-MDS 的關鍵性試驗。您提到了潛在的血栓風險，這是非常謹慎的做法，應該將其納入試驗中。但我只是好奇，從流行病學的角度來看，在二線或更晚期治療中，對於 ESA 無效或不耐受的患者，您認為有多少比例的患者會因為血栓風險而被篩檢出來？

Maybe related to that, basically, I'm just curious about the cost of running that Phase 3 trial, whether -- or how would that impact the 2028 cash guidance that you provided.

或許與此有關，我主要是好奇開展這項 3 期試驗的成本，以及這會對您提供的 2028 年現金流預期產生怎樣的影響。

I will have quick follow-up. Thank you.

我會盡快跟進。謝謝。

Yeah. Thanks, Andy. Nice to hear from you. I appreciate the questions.

是的。謝謝你，安迪。很高興收到你的來信。感謝大家的提問。

As it relates to the thrombotic risk and what that could potentially do to the size of the patient population, I think that it'll be dependent, really, upon two things.

至於血栓風險以及這可能對患者群體規模的影響，我認為這實際上取決於兩件事。

One is, what is the ultimate exclusion criteria that we align on with the FDA?

第一個問題是，我們與 FDA 達成一致的最終排除標準是什麼？

And then, second, ultimately, what is the data report from the Phase 3 trial?

其次，最終，3 期試驗的數據報告是什麼？

I think it's too early for us to even estimate -- is it a really small proportion of the total population of Phase-2-and-beyond patients in lower-risk MDS? Or is it more of a moderate portion of the population?

我認為現在估計還為時過早——這是否只是低風險 MDS 患者中 2 期及以後階段總人口的一小部分？或者說，這只是人口中的中等比例？

Our hypothesis is it's a pretty small amount of the patient potential. But we would not know that until we really align on the inclusion and exclusion criteria with the agency; ultimately run the trial; see the data; and then, figure out exactly what the label says, should we have a positive trial and a positive registration.

我們的假設是，這只是潛在患者的一小部分。但是，只有當我們真正與監管機構就納入和排除標準達成一致；最終開展試驗；查看數據；然後，如果我們試驗和註冊都取得了積極成果，才能弄清楚標籤上究竟寫些什麼。

In terms of the cost of the trial, we're estimating it that it will cost in the neighborhood of $50 million to $60 million, assuming about 200 patients in enrollment period of 18 to 24 months.

就試驗成本而言，我們估計在 5,000 萬至 6,000 萬美元左右，假設招募期為 18 至 24 個月，招募人數約 200 人。

But I'll let Dave comment on how we're thinking about that, in terms of our cash runway and our guidance. Dave?

但我會讓戴夫來評論我們是如何考慮這個問題的，包括我們的現金儲備和業績指引。戴夫？

Yeah. Sure. Thank you, Thane.

是的。當然。謝謝你，泰恩。

Right now, our current guidance reflects the cash runway into 2028. That does not contemplate taking on the Phase 3 study on our own.

目前，我們的現金流量預期能夠維持到 2028 年。這並不包括我們自行進行第三階段研究。

To your point, Andy, obviously, it would impact our cash guidance. We think that, if we decide to take it on our own, without raising incremental capital, it could take the cash guidance into the second half of 2027, give or take. But we do expect that we would be looking to bring on incremental capital to help support the cost of running the Phase 3 study, if we were to take it on our own.

安迪，你說得對，這顯然會影響我們的現金流預期。我們認為，如果我們決定自行承擔，而不籌集額外資金，現金流預期可能會持續到 2027 年下半年左右。但如果我們自行進行 3 期研究，我們預計需要引入額外的資金來幫助支付研究成本。

(multiple speakers)

（多位發言者）

Andy, maybe one -- yeah. One final comment on that, Andy, is, as we said in our prepared remarks, as we are evaluating the potential to run the trial on our own versus the partnering process, which we have commenced, ultimately, it's going to come down to a combination of what we would call strategic and economic considerations.

安迪，也許一個——是的。安迪，關於這一點，我還有最後一點要補充，正如我們在準備好的發言稿中所說，我們正在評估是自行開展試驗還是通過我們已經啟動的合作流程，最終，這將取決於我們所說的戰略和經濟因素的綜合考量。

On the economic front, we would have to bring in additional capital per days point. We've started to have those conversations just to see what the potential or the likelihood for us to be able to do that. And then, we'll compare that as we advance the partnering process. We'll be able to compare that side by side and, ultimately, do what we think is in the best interest of shareholders.

在經濟方面，我們需要每天投入額外的資金。我們開始進行這些對話，只是為了看看我們實現這一目標的可能性有多大。然後，隨著合作進程的推進，我們將對結果進行比較。我們將能夠進行並排比較，並最終做出我們認為最符合股東利益的決定。

I see. Okay. Great.

我懂了。好的。偉大的。

And then, maybe a big-picture question on the prostate cancer landscape. There's a lot of targets out there, PSMA; C1; DLL3; CD46, obviously; and then, most interestingly, Bombesin, which has a negative expression correlation profile versus PSMA.

然後，或許可以提出一個關於前列腺癌現狀的大局性問題。有許多靶點，例如 PSMA；C1；DLL3；CD46，顯然；然後，最有趣的是鈴蟾肽，它與 PSMA 的表達相關性為負。

Do we have additional, maybe, academic work that look at some of the overlapping expression profile that could actually be advantageous for CD47 to position based on the expression levels? Just curious about your thinking on that front. Thanks.

我們是否有其他學術研究，探討一些重疊的表達譜，這些表達譜實際上可能對 CD47 根據其表達水平進行定位有利？只是好奇你在這方面是怎麼想的。謝謝。

No. Thanks, Andy. It's a really good question. One that we talk about on a pretty regular basis. We've got a great group of KOLs who are beginning to help us think through this, as well.

不。謝謝你，安迪。這確實是個好問題。這是我們經常談到的一個話題。我們還有一群很棒的意見領袖，他們也開始幫助我們思考這個問題。

If we think about expression levels of CD46, we probably can best characterize it as it relates to expression levels of PSMA. We know that there's a great degree of concordance in patients who express the CD46 epitope and those that express PSMA.

如果我們考慮 CD46 的表達水平，我們或許可以透過它與 PSMA 表達水平的關係來最好地描述它。我們知道，表達 CD46 表位的患者與表達 PSMA 的患者之間存在高度一致性。

We do know that as patients are treated with androgen receptor inhibitors and are treated with a taxane or potentially, even Pluvicto, that we see some resistance to PSMA develop. We actually see PSMA expression levels go down.

我們知道，當患者接受雄性激素受體抑制劑治療，並接受紫杉烷類藥物治療，甚至可能接受 Pluvicto 治療時，我們發現對 PSMA 產生了一些抗藥性。我們實際上觀察到PSMA表達水平下降。

We're going to be able to tell a lot more, we believe, from our Phase 2 monotherapy trial, where we're going to treat all the patients with the CD46 PET imaging agent to be able to characterize the varied expression levels. We do think we'll have some data on many of those patients in terms of their previous PSMA expression levels, as well. We'll be able to then do a correlation assessment based upon those expression levels in response to the ADC. And then, we'll also be able to look at the data, albeit in probably a smaller number of patients, of how our ADC performs in patients who were previously on Pluvicto and those that weren't.

我們相信，透過 2 期單藥治療試驗，我們將能夠了解更多資訊。在該試驗中，我們將使用 CD46 PET 造影劑治療所有患者，以便能夠表徵不同的表現量。我們認為我們也能獲得許多患者先前 PSMA 表達水平的一些數據。然後，我們將能夠根據這些表達量對 ADC 的反應進行相關性評估。然後，我們還可以查看數據（儘管可能患者數量較少），以了解我們的 ADC 在先前接受過 Pluvicto 治療的患者和未接受 Pluvicto 治療的患者中的表現。

Again, given this signal that we've seen where it seems that as patients progress and are treated with the taxanes and potentially with Pluvicto, that their PSMA levels are altered to some degree.

再次鑑於我們已經看到的信號，即隨著患者病情進展並接受紫杉烷類藥物治療，以及可能接受 Pluvicto 治療，他們的 PSMA 水平似乎會在某種程度上發生改變。

We're not probably going to have much data from our Phase 2 as it relates to any of the other targets. There is, as you stated, some academic work that's been done that looks at expression levels of (inaudible) to CD46, PSMA, et cetera. And so it's probably premature for us to come on this point in time as it relates to how CD46 might overlap with the expression of some of those other targets.

由於第二階段試驗涉及其他靶點，我們可能不會獲得太多相關數據。正如您所說，已經有一些學術研究探討了 CD46、PSMA 等的表達量。因此，現在討論 CD46 如何與某些其他標靶的表達重疊可能還為時過早。

Great. That's helpful. Look forward to the second-half 2026 interim readout.

偉大的。那很有幫助。敬請期待 2026 年下半年的中期報告。

Matthew Keller, H.C. Wainwright.

馬修凱勒，H.C. 溫賴特。

Oh. Yeah. Hey, guys. Thanks for the update. Thanks for taking your question.

哦，是的。嘿，夥計們。謝謝你的更新。感謝您回答我的問題。

Just one from us. On 3246, I was wondering if you could provide a little bit more color or what your thoughts are and what we can expect, specifically from the top-line data out of the IST study? Really, what we're trying to get at is, more specifically, what are you considering a success from this data readout?

我們只提供一份。關於第 3246 頁，我想請您提供更多信息，或者您的想法以及我們可以期待些什麼，特別是從 IST 研究的初步數據中？實際上，我們想更具體地了解的是，您認為從這份數據解讀中，什麼才算成功？

Yeah. Thanks, Matt. I'll go ahead and start. Dave, feel free to add comments afterwards, as well.

是的。謝謝你，馬特。我先開始了。Dave，之後也歡迎你補充評論。

In the preliminary efficacy data from the 1b portion of the combination trial, there was a preliminary efficacy estimate of 10.2 months. So we would see something consistent with that. I think that that would be pretty encouraging for us.

在聯合試驗 1b 部分的初步療效數據中，初步療效估計為 10.2 個月。所以我們會看到與此相符的情況。我認為這對我們來說是個相當大的鼓舞。

I think it's going to be important to look at the data, on the roughly 44 patients or so, and how that data shakes out, based upon the number of prior ARPI that a particular patient has been on. We think that that will be a part of the disclosure, given the IST nature of that particular trial.

我認為，查看大約 44 名患者的數據，以及根據特定患者之前使用 ARPI 的數量來分析這些數據，將會非常重要。我們認為，鑑於該特定試驗的IST性質，這將是揭露的一部分。

Clearly, we're hands off, on the disclosure and what that disclosure, that information, will say. But I think that that will be also an important part of the learning. We do know that the higher the number of ARPIs that patients are treated with, obviously, regardless of what comes next, you see a declining rPFS. And so I think that that will be an important part of the disclosure.

顯然，我們不會幹預資訊揭露以及揭露的內容。但我認為這也將是學習過程中重要的一環。我們知道，患者接受 ARPI 治療的數量越多，顯然，無論接下來採取什麼措施，rPFS 都會下降。所以我認為這將是披露的重要組成部分。

Dave, anything to add to that?

戴夫，你還有什麼要補充的嗎？

No. I think you hit the nail on the head. Thank you.

不。我覺得你說得太對了。謝謝。

Chen Lin, Lin Asset Management.

陳琳，林資產管理公司。

Hi, guys. Thank you for taking my questions. Many of my questions have been answered.

嗨，大家好。謝謝您回答我的問題。我的很多疑問都得到了解答。

Just curious, there's a line of liability of $63 million, on your report. Is that related to the milestone payment for the ADC assets?

我只是好奇，你們的報告上有一項6,300萬美元的負債。這和ADC資產的里程碑付款有關嗎？

I'll take that.

我接受。

No. That liability is actually related to the royalties associated with our royalty financing with NovaQuest Capital Management. That is associated with our royalty stream from Roxadustat sales in CKD in the European and Japanese territories where we are partnered with Astellas.

不。該負債實際上與我們透過 NovaQuest Capital Management 進行的特許權使用費融資相關的特許權使用費有關。這與我們在歐洲和日本地區（我們與安斯泰來公司合作）銷售 CKD 藥物 Roxadustat 所獲得的特許權使用費有關。

Oh. Okay. Great. So that's the royalty stream. You own royalty, right? And then, you sold some royalty. That's that for that, okay.

哦好的。偉大的。這就是版稅收入。你擁有版稅，對吧？然後，你賣掉了一些版稅。就到此為止吧，好的。

Is there a minimum payment for that royalty? What's the liability look like? Or it will just -- your future revenue will be covered that?

該版稅是否有最低支付額？責任範圍是怎樣的？或者就只是──你未來的收入就能彌補這一點？

Yeah. Currently, the way the deal is structured is that we owe NovaQuest 22.5% of any of the royalties received in those territories. So FibroGen, Inc., owes 77.5%; and then, the 22.5% are paid out to NovaQuest Capital Management on an annual basis.

是的。目前，該協議的結構是，我們需要向 NovaQuest 支付在這些地區收到的任何版稅的 22.5%。因此，FibroGen 公司欠款 77.5%；然後，剩餘的 22.5% 將按年支付給 NovaQuest Capital Management。

Okay. Great. So it's a line item and not actual, the royalty, that you owe them, going forward. Great. Thank you for this clarification.

好的。偉大的。所以這只是一個項目，而不是你今後應該支付給他們的實際版稅。偉大的。感謝您的澄清。

Do you have any other line item for the potential future milestone you need to pay for the ADC, going forward, in the financial report?

在財務報告中，您是否還有其他項目需要用於支付未來可能需要支付的ADC款項？

Yeah. Dave, I'll take that. I'll take that one.

是的。戴夫，我收下。我選那個。

Chen, the only future milestone that we would have in the relatively near term related to the agreement that we struck with Fortis in May of 2023 would be if we decide, based upon the Phase 2 data, to move the program into Phase 3. We would then exercise the option to acquire Fortis Therapeutics for $80 million.

陳先生，根據我們與 Fortis 在 2023 年 5 月達成的協議，在相對較短的時間內，我們唯一可能取得的里程碑是，根據第二階段的數據，決定將該項目推進到第三階段。然後我們將行使選擇權，以 8000 萬美元收購 Fortis Therapeutics。

We would then run the Phase 3 trial. If the data supports, then a filing. If the product were ultimately to get approved in either the US or Europe, we would then owe them an additional milestone, based on approval, of $75 million.

接下來我們將進行第三階段試驗。如果數據支持，則提交備案。如果該產品最終在美國或歐洲獲得批准，我們將根據批准情況向他們支付額外的里程碑款項 7500 萬美元。

And then, there would be no royalty obligation on net sales to Fortis after that. There would be a very small single-digit royalty obligation to UCSF but not to Fortis.

此後，Fortis 將不再承擔淨銷售額的特許權使用費義務。UCSF 將承擔非常小的個位數版稅義務，但 Fortis 則無需承擔版稅義務。

Just to add to that: The reason why we don't carry the liability on the balance sheet is because it is fully at our discretion. As Thane pointed out, if the Phase 2 trial is successful and we like what we see, we can exercise that option. If we do not like what we see, then we can return the asset back to Fortis Therapeutics. So it is fully in FibroGen's discretion, based upon the outcome of the Phase 2 study of FG-3246.

補充一點：我們不在資產負債表上列出該負債的原因是，這完全由我們自行決定。正如 Thane 所指出的那樣，如果 2 期試驗成功，並且我們對結果滿意，我們可以行使該選擇權。如果我們對所看到的不滿意，我們可以將該資產退還給 Fortis Therapeutics。因此，這完全由 FibroGen 根據 FG-3246 的 2 期研究結果自行決定。

Okay. Great. Thank you. That clarifies a lot.

好的。偉大的。謝謝。這解釋了很多問題。

When do you expect to decide which pathway you go with the LR-MDS; this new Phase 3 trial? Do you want to wait for the Phase 2 interim results or you plan to move it forward before that?

您預計何時決定 LR-MDS 的治療方案，即這項新的 3 期臨床試驗？您是想等待第二階段中期結果，還是計劃在此之前推進？

Yeah. Thanks, Chen.

是的。謝謝陳。

Now, well, and these are completely independent of one another. And so we're looking at the low-risk MDS opportunity for Roxadustat by itself as a standalone.

嗯，而且這些彼此之間完全獨立。因此，我們正在研究羅沙司他單獨用於治療低風險 MDS 的機會。

I would think that we'd be able to have some clarity on the path forward, whether we do it on our own versus whether we partner it. Probably in the second quarter of next year, we'll have better clarity on that.

我認為我們應該能夠更清楚地了解未來的發展方向，是獨立完成還是與他人合作。可能到明年第二季度，我們就能更清楚地了解狀況了。

Thank you. Ladies and gentlemen, I'm showing no further questions in the queue.

謝謝。女士們先生們，隊列中不再顯示任何問題。

I would now like to turn the call back over to Thane for closing remarks.

現在我想把電話轉回給塔恩，請他作總結發言。

Yeah. Thank you. Thanks, everybody, for joining us for today's third-quarter earnings call.

是的。謝謝。感謝各位參加今天的第三季財報電話會議。

We appreciate your continued interest in FibroGen.

感謝您一直以來對 FibroGen 的關注。

Have a great rest of your day. Thank you.

祝您今天餘下的時間過得愉快。謝謝。

Ladies and gentlemen, that concludes today's conference call.

女士們、先生們，今天的電話會議到此結束。

Thank you for your participation. You may now disconnect.

感謝您的參與。您現在可以斷開連線了。