FibroGen Inc (FGEN) 2025 Q1 法說會逐字稿

Good day, and thank you for standing by. Welcome to FibroGen first quarter 2025 earnings conference call. (Operator Instructions). Please be advised today's conference is being recorded.

您好，感謝您的支持。歡迎參加 FibroGen 2025 年第一季財報電話會議。（操作員指令）。請注意，今天的會議正在錄製。

I would not like to end the conference over to your speaker today, Joanne Geller. Please, go ahead.

我不想讓今天的會議以演講者喬安妮·蓋勒 (Joanne Geller) 的發言結束。請繼續。

Thank you, operator. Good afternoon, everyone. Thank you for joining today to discuss FibroGen's first quarter 2025 financial and business results.

謝謝您，接線生。大家下午好。感謝您今天參加討論 FibroGen 2025 年第一季的財務和業務業績。

I'm Joanne Geller from LifeSci Advisors. Joining me on today's call are Thane Wettig, our Chief Executive Officer; and David DeLucia, our Chief Financial Officer. Following the prepared remarks, we will open the call to your questions.

我是 LifeSci Advisors 的 Joanne Geller。參加今天電話會議的還有我們的執行長 Thane Wettig 和我們的財務長 David DeLucia。聽完準備好的發言後，我們將開始回答大家的提問。

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, our collaborations with AstraZeneca and Astellas, financial guidance, initiation, enrollment, design, conduct, and results of clinical trials, our regulatory strategies and potential regulatory results, our research and development activities, commercial results, and results of operations, risks related to our business, and certain other business matters. 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.

我想提醒您，今天電話會議的言論包括有關 FibroGen 的前瞻性陳述。此類聲明可能包括但不限於我們與阿斯特捷利康和阿斯特捷利康的合作、財務指導、臨床試驗的啟動、招募、設計、實施和結果、我們的監管策略和潛在的監管結果、我們的研發活動、商業成果和經營成果、與我們的業務相關的風險以及某些其他業務事項。每個前瞻性陳述都存在風險和不確定性，可能導致實際結果和事件與該陳述中的預測有重大差異。

A more complete description of these and other material risks can be found in FibroGen's filings with the SEC, including our most recent Form 10-K and Form 10-Q. FibroGen does not undertake any obligation to update publicly any forward-looking statements, whether as a result of new information, future events, or otherwise.

有關這些風險和其他重大風險的更完整描述可以在 FibroGen 向美國證券交易委員會提交的文件中找到，包括我們最新的 10-K 表格和 10-Q 表格。FibroGen 不承擔公開更新任何前瞻性聲明的義務，無論由於新資訊、未來事件或其他原因。

The press release reporting the company's financial results and business update, and a webcast of today's conference call, can be found on the investor 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 的投資者部分找到。

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

說到這裡，我想把電話轉給執行長 Thane Wettig。領主？

Thank you, Joanne. Good afternoon, everyone, and welcome to our first quarter 2025 earnings call. On today's call, I will provide a status update on the transformation of FibroGen, which includes the divestiture of FibroGen China and a laser focus on our US pipeline opportunities, specifically the exciting prospects for FG-3246 and FG-3180, our potential first-in-class antibody drug conjugate targeted in CD46, and our PET imaging agent in metastatic castration-resistant prostate cancer. And for roxadustat in the treatment of anemia due to lower-risk myelodysplastic syndrome. Then, David DeLucia, our CFO, will review the financials, after which we will open the call for your questions.

謝謝你，喬安妮。大家下午好，歡迎參加我們 2025 年第一季財報電話會議。在今天的電話會議上，我將提供有關 FibroGen 轉型的最新情況，其中包括剝離 FibroGen China 並重點關注我們的美國管道機會，特別是 FG-3246 和 FG-3180 的激動人心的前景，我們的潛在首創抗體藥物偶聯物針對 CD46，以及我們用於治療轉移性去勢抗性前列腺癌的 PET 成像劑。以及羅沙司他治療低風險骨髓增生異常綜合症引起的貧血。然後，我們的財務長 David DeLucia 將審查財務狀況，之後我們將開始回答您的問題。

On slide 3, I would like to highlight the strategic priorities we've set forth for FibroGen this year. I'll begin by providing an update on the sale of FibroGen China to AstraZeneca. As we've stated previously, this is a truly transformative transaction for FibroGen as it simplifies our operations, allows for the payoff of our term loan facility with Morgan Stanley Tactical Value, and provides the most efficient pathway to access the company's net cash held in China.

在投影片 3 上，我想強調我們今年為 FibroGen 制定的策略重點。首先，我將介紹 FibroGen China 賣給阿斯特捷利康的最新情況。正如我們之前所說，這對 FibroGen 來說是一項真正具有變革意義的交易，因為它簡化了我們的運營，使我們能夠償還摩根士丹利戰術價值的定期貸款，並提供了獲取公司在中國持有的淨現金的最有效途徑。

At the time of the announcement in February, the total consideration for the sale was expected to be approximately $160 million, which included an equity value of $85 million and expected net cash in China of approximately $75 million. We are pleased to share that we expect the total consideration to now be approximately $185 million, which is a $25 million increase from our initial guidance due to greater than expected net cash in China at closing. Importantly, the increase in expected proceeds extends the company's cash runway into the second half of 2027. We now expect the transaction to close in the third quarter of this year.

在二月宣布這項消息時，預計此次出售的總對價約為 1.6 億美元，其中包括 8,500 萬美元的股權價值和預計在中國的約 7,500 萬美元淨現金。我們很高興地告訴大家，我們預計總對價現在約為 1.85 億美元，比我們最初的預期高出 2500 萬美元，原因是交易結束時中國境內的淨現金高於預期。重要的是，預期收益的增加將使公司的現金流量延長至 2027 年下半年。我們現在預計該交易將在今年第三季完成。

Second, we remain hyper-focused on advancing FG-3246 and FG-3180 in metastatic castration-resistant prostate cancer or mCRPC, in which we continue to make important progress. We recently announced in March the publication of the full trial results from the Phase 1 monotherapy study of FG-3246 in patients with mCRPC in the Journal of Clinical Oncology, which highlights the promising potential of its anti-cancer activity, especially when considering the unselected, heavily pretreated patient population.

其次，我們仍然高度重視推進 FG-3246 和 FG-3180 在轉移性去勢抵抗性前列腺癌或 mCRPC 領域的研究，並在此領域不斷取得重要進展。我們最近於 3 月宣佈在《臨床腫瘤學雜誌》上發表了 FG-3246 針對 mCRPC 患者的 1 期單藥治療研究的完整試驗結果，這凸顯了其抗癌活性的巨大潛力，尤其是考慮到未經選擇的、接受過大量預處理的患者群體。

We believe the trial results demonstrate that the CD46 target is active and provide key insights into the potential clinical impact of targeting CD46-expressing tumors. We are excited to share that we recently received notification from the FDA clearing the IND for FG-3180, our companion PET imaging agent. This marks an important achievement for FibroGen as it paves the pathway for FG-3180 to be used alongside FG-3246 in the upcoming Phase 2 dose optimization monotherapy trial, which is expected to start in the third quarter.

我們相信試驗結果表明 CD46 標靶是活躍的，並為針對 CD46 表達腫瘤的潛在臨床影響提供了關鍵見解。我們很高興地告訴大家，我們最近收到了 FDA 的通知，批准我們的配套 PET 造影劑 FG-3180 的 IND。這標誌著 FibroGen 取得了一項重要成就，為 FG-3180 與 FG-3246 在即將進行的 2 期劑量優化單藥治療試驗中使用鋪平了道路，該試驗預計將於第三季度開始。

Third, for roxadustat, FibroGen recently filed a type C meeting request with the FDA to gain feedback on the potential path forward for roxadustat in anemia associated with lower-risk myelodysplastic syndromes, an indication with significant unmet medical need.

第三，對於羅沙司他，FibroGen 最近向 FDA 提交了一份 C 類會議請求，以獲得有關羅沙司他治療低風險骨髓增生異常綜合徵相關貧血的潛在發展方向的反饋，該疾病具有重大未滿足的醫療需求。

In the post hoc subgroup analysis from the MATTERHORN Phase 3 trial, roxadustat showed promise in reducing transfusion dependence in patients with a higher transfusion burden at baseline. We expect FDA feedback in the third quarter that will provide important clarity on the path forward for roxadustat in the US, with the aim of realizing additional value for this wholly owned asset.

在 MATTERHORN 第 3 階段試驗的事後亞組分析中，羅沙司他顯示出有望降低基線輸血負擔較高的患者的輸血依賴。我們預計 FDA 在第三季的回饋將為羅沙司他在美國的發展方向提供重要的明確性，目的是為這項全資資產實現額外的價值。

Altogether, we are confident that our refined focus, multiple near-term catalysts across both clinical programs, and our existing strong foundation position us well to create value for shareholders now and in the future. I will now provide a brief overview of our FG-3246 and FG-3180 programs in mCRPC.

總而言之，我們相信，我們精細化的重點、兩個臨床項目的多個近期催化劑以及我們現有的強大基礎使我們能夠在現在和將來為股東創造價值。我現在將簡要概述我們在 mCRPC 中的 FG-3246 和 FG-3180 程序。

Slide 5 highlights the high unmet need in late-stage prostate cancer. There are approximately 290,000 men diagnosed with prostate cancer each year in the US. Of these, there are 65,000 drug-treatable patients where the cancer has metastasized and become castrate-resistant, resulting in a grim five-year survival rate of approximately 30%. There remains a significant opportunity for new treatments that can extend survival for these men, with a total addressable market of well over $5 billion in annual sales. FG-3246 could become a non-PSMA treatment option that is so desperately needed given the significant unmet need in mCRPC.

投影片 5 強調了晚期前列腺癌的巨大未滿足需求。美國每年約有 29 萬名男性被診斷出罹患攝護腺癌。其中，有 65,000 名可採用藥物治療的患者癌症已發生轉移並產生去勢抵抗性，五年存活率僅約 30%。新的治療方法仍具有重大發展機遇，可以延長這些患者的生存期，其潛在市場總額年銷售額將超過 50 億美元。鑑於 mCRPC 領域存在大量未滿足的需求，FG-3246 可能成為一種迫切需要的非 PSMA 治療選擇。

Turning to slide 6, we highlight the novelty of our target, a tumor-selective epitope of CD46. CD46 and this specific CD46 epitope have several distinguishing features. First, CD46 is upregulated during tumorigenesis and helps tumors evade complement-dependent cytotoxicity. The CD46 epitope is highly expressed in mCRPC tissues with lower interpatient variability and higher median expression compared with PSMA, as depicted in the graph on the right-hand portion of the slide.

翻到投影片 6，我們重點介紹了我們的目標的新穎性，即 CD46 的腫瘤選擇性表位。CD46 和該特定的 CD46 抗原決定位具有幾個顯著特徵。首先，CD46 在腫瘤發生過程中上調，並幫助腫瘤逃避補體依賴性細胞毒性。CD46 抗原決定位在 mCRPC 組織中高度表達，與 PSMA 相比，患者間變異性較低且中位數表達較高，如幻燈片右側的圖表所示。

Importantly, the expression of CD46 is 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. The CD46 epitope is also overexpressed in colorectal cancer and other solid tumors.

重要的是，CD46 的表達在從局部去勢敏感性前列腺癌發展到轉移性去勢抵抗性前列腺癌的過程中上調，並且在用雄激素信號抑製劑治療後進一步過度表達。CD46表位在大腸直腸癌和其他實體腫瘤中也過度表現。

Turning to slide 7, FG-3246 is a potential first-in-class ADC in development for mCRPC with a novel targeting antibody YS5, which binds to the tumor-selective epitope of CD46 along with an MMAE payload. MMAE is a validated payload that is approved as part of a number of ADCs and other oncology indications. FG-3246 represents an androgen receptor agnostic approach, clinically differentiating it from other prostate cancer treatments currently in development.

翻到幻燈片 7，FG-3246 是一種針對 mCRPC 開發的潛在首創 ADC，具有新型靶向抗體 YS5，可與 MMAE 有效載荷結合 CD46 的腫瘤選擇性表位。MMAE 是一種經過驗證的有效載荷，已被批准為多種 ADC 和其他腫瘤學適應症的一部分。FG-3246 代表了一種雄激素受體不可知論方法，在臨床上將其與目前正在開發的其​​他前列腺癌治療方法區分開來。

A companion PET imaging agent, FG-3180, utilizes the same YS5 targeting antibody as FG-3246 and is also under clinical development. In preclinical studies, the PET imaging agent has demonstrated specific targeting of and uptake by CD46-positive tumor cells. We believe that having a patient selection biomarker would not only allow us to better enrich the patient population in the Phase 3 portion of the clinical development program, but it would also enable differentiation for FG-3246 in the prostate cancer treatment paradigm.

配套 PET 造影劑 FG-3180 採用與 FG-3246 相同的 YS5 靶向抗體，也正在臨床開發中。在臨床前研究中，PET 成像劑已證明能夠特異性靶向並被 CD46 陽性腫瘤細胞吸收。我們相信，擁有患者選擇生物標記不僅可以讓我們更好地豐富臨床開發計劃第 3 階段的患者群體，而且還可以使 FG-3246 在前列腺癌治療範例中實現差異化。

In addition, FG-3180 could represent an important commercial opportunity as a companion diagnostic to FG-3246, similar to the existing PSMA PET agents such as PYLARIFY. We are excited to announce that we have recently received IND clearance for FG-3180, paving the way for FG-3180 to be an important component for the upcoming Phase 2 dose optimization study that I will touch on in a moment.

此外，FG-3180 作為 FG-3246 的伴隨診斷可能代表一個重要的商業機會，類似於現有的 PSMA PET 藥物（如 PYLARIFY）。我們很高興地宣布，我們最近獲得了 FG-3180 的 IND 批准，這為 FG-3180 成為即將進行的第 2 階段劑量優化研究的重要組成部分鋪平了道路，我稍後會談到這一點。

Slide 8 recaps the top-line results from the Phase 1 monotherapy study with full details published in the peer-reviewed Journal of Clinical Oncology in March of this year. The completed monotherapy study included a total of 56 metastatic castration-resistant prostate cancer patients who were biomarker unselected and were heavily pre-treated, receiving a median of five lines of therapy prior to FG-3246.

第 8 張投影片概括了第一階段單一療法研究的頂線結果，其詳細資訊於今年 3 月發表在同行評審的《臨床腫瘤學雜誌》上。已完成的單藥治療研究共納入了 56 名轉移性去勢抵抗性前列腺癌患者，這些患者未經生物標誌物選擇且接受過大量預先治療，在接受 FG-3246 治療之前平均接受了五種療法。

In the efficacy evaluable population of 40 patients, a median radiographic progression-free survival of 8.7 months was observed. There was an overall response rate of 20% confirmed by RECIST 1.1, and PSA reductions of greater than 50% were achieved in 36% of patients. Adverse events were consistent with those observed with other MMAE-based ADC therapies.

在 40 名可評估療效的患者群體中，觀察到中位放射學無惡化存活期為 8.7 個月。經 RECIST 1.1 確認的整體反應率為 20%，36% 的患者 PSA 降低超過 50%。不良事件與其他基於 MMAE 的 ADC 療法觀察到的不良事件一致。

Additional highlights from the JCO publication include the expression of CD46 being observed in 80% of evaluable biopsies in patients enrolled during the dose expansion phase, which is consistent with results previously reported from a prospectively obtained cohort of patients who underwent metastatic CRPC biopsy.

JCO 出版物的其他亮點包括在劑量擴展階段入組的患者中 80% 的可評估活檢中觀察到 CD46 的表達，這與先前從接受轉移性 CRPC 活檢的前瞻性患者隊列中報告的結果一致。

20 patients had evaluable circulating tumor DNA at baseline, on treatment defined as before the cycle 2 day 1 dose, and at the end of treatment or disease progression. In 9 of these 20 patients, or 45% of those evaluable, there was a greater than 50% decline from baseline in ctDNA fraction after just one cycle of treatment.

20 名患者在基線、治療期間（定義為第 2 個週期第 1 天給藥之前）以及治療結束時或疾病進展時具有可評估的循環腫瘤 DNA。在這 20 名患者中，有 9 名（佔可評估患者的 45%）在僅接受一個療程的治療後，其 ctDNA 分數就從基線下降了 50% 以上。

A tighter dose-response relationship appeared to be observed for objective tumor response by imaging as opposed to serum PSA decline, which may be related to the independence of CD46 from the androgen signaling pathway and expression of CD46 in androgen receptor-independent tumor clones.

與血清 PSA 下降相比，透過影像觀察到的客觀腫瘤反應似乎具有更緊密的劑量反應關係，這可能與 CD46 獨立於雄激素信號通路以及 CD46 在雄激素受體非依賴性腫瘤克隆中的表達有關。

Finally, anti-tumor activity was observed in patients who had received more than one previous line of ARPI therapy, as well as those who had received taxane chemotherapy in the metastatic castration-sensitive setting, the latter being notable given similar mechanisms of action of taxane and MMAE. Based on the totality of the data from the Phase 1 monotherapy trial, we are encouraged by the clinical activity of FG-3246 in targeting CD46 in mCRPC.

最後，在接受過一線以上 ARPI 療法的患者以及在轉移性去勢敏感環境中接受過紫杉烷化療的患者中觀察到了抗腫瘤活性，後者因紫杉烷和 MMAE 的作用機制相似而引人注目。根據 1 期單藥治療試驗的全部數據，我們對 FG-3246 針對 mCRPC 中的 CD46 的臨床活性感到鼓舞。

On slide 9, we highlight the rPFS results of FG-3246 in its Phase 1 study versus other comparable early-stage studies. As covered on the previous slide, the Phase 1 study of FG-3246 demonstrated an rPFS of 8.7 months across a robust sample size of 40 heavily pre-treated patients. While we cannot make direct comparisons to these trials due to the differences in study design and prior prostate cancer treatments, we are encouraged by these rPFS results, which is a recognized regulatory endpoint in prostate cancer trials.

在投影片 9 上，我們重點介紹了 FG-3246 在其第 1 階段研究中與其他類似早期研究的 rPFS 結果。如上一張投影片所述，FG-3246 的 1 期研究表明，在 40 名接受過大量預先治療的患者組成的穩健樣本中，rPFS 為 8.7 個月。雖然由於研究設計和先前前列腺癌治療的差異，我們無法直接比較這些試驗，但這些 rPFS 結果令我們感到鼓舞，這是前列腺癌試驗中公認的監管終點。

On slide 10, we highlight previously reported preliminary efficacy data from the Phase 1b portion of the ongoing investigator-sponsored combination study with enzalutamide. These interim results included data on 17 biomarker unselected patients, 70% of whom were pre-treated with at least two prior ARSIs.

在第 10 張投影片上，我們重點介紹了正在進行的研究者贊助的恩雜魯胺聯合研究的 1b 期部分的先前報告的初步療效數據。這些中期結果包括 17 名未選擇生物標記的患者的數據，其中 70％ 的患者之前接受過至少兩次 ARSI 治療。

In addition to establishing the Phase 2 dose of FG-3246, the IST also demonstrated an encouraging 10.2 months of radiographic progression-free survival, with PSA declines observed in 71% of evaluable patients. We expect to report the Phase 2 top-line results in the fourth quarter of this year, which will also include data on CD46 expression in patients treated with FG-3180, our PET biomarker, during the Phase 2 portion of the IST.

除了確定 FG-3246 的 2 期劑量外，IST 還顯示出令人鼓舞的 10.2 個月放射學無惡化存活期，71% 的可評估患者出現 PSA 下降。我們預計將在今年第四季度報告第 2 階段的頂線結果，其中還將包括在 IST 第 2 階段期間使用我們的 PET 生物標記 FG-3180 治療的患者的 CD46 表達數據。

On slide 11, we depict a comparison of the initial results from the monotherapy trial in heavily pre-treated patients and the combination trial for FG-3246 versus the rPFS results from second-line therapies in late-stage trials. Again, while we cannot make direct comparisons to these trials due to the differences in study design and previous prostate cancer treatments, we are encouraged that FG-3246 demonstrates what we believe to be competitive rPFS results.

在投影片 11 上，我們描述了對接受過大量預先治療的患者進行的單一療法試驗和 FG-3246 聯合試驗的初步結果與後期試驗中二線療法的 rPFS 結果的比較。再次，雖然由於研究設計和先前的前列腺癌治療的差異，我們無法直接比較這些試驗，但我們很高興看到 FG-3246 展示了我們認為具有競爭力的 rPFS 結果。

Slide 12 highlights the Phase 2 monotherapy dose optimization trial design that is based on our discussion with the FDA. We plan to initiate the study next quarter and expect to enroll 75 patients in the post-ARSI pre-chemo setting across three dose levels to determine the optimal dose for Phase 3 based on efficacy, safety, and PK parameters. 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.

投影片 12 重點介紹了基於我們與 FDA 的討論的第 2 階段單藥治療劑量優化試驗設計。我們計劃於下個季度啟動這項研究，預計將在三個劑量水平上招募 75 名 ARSI 後化療前患者，以根據療效、安全性和 PK 參數確定第 3 階段的最佳劑量。值得注意的是，當我們試圖證明所有人群中 CD46 表達與 ADC 反應之間的相關性時，FG-3180 將成為研究的一個組成部分。

One other important design element is the use of UCSF as primary prophylaxis to mitigate Grade 3 or greater adverse events associated with neutropenia commonly seen with MMAE payloads. The addition of UCSF may enable a better tolerated and more consistent treatment with the ADC, minimizing dose interruptions or dose reductions, extending duration of therapy, and potentially enhancing the efficacy of the ADC. We are planning an interim analysis in the second half of 2026, which will include efficacy, safety, PK, and exposure-response data, and we intend to share relevant data with all stakeholders as they become available, given the open-label design.

另一個重要的設計元素是使用 UCSF 作為主要預防措施，以減輕 MMAE 有效載荷中常見的與中性粒細胞減少症相關的 3 級或更高級別不良事件。添加 UCSF 可使 ADC 治療具有更好的耐受性和更一致的治療效果，最大限度地減少劑量中斷或劑量減少，延長治療時間，並可能增強 ADC 的療效。我們計劃在 2026 年下半年進行中期分析，其中將包括功效、安全性、藥物動力學和暴露反應數據，並且鑑於開放標籤設計，我們打算在相關數據可用時與所有利益相關者分享。

Slide 13 highlights why we are so optimistic about the potential for the Phase 2 study to further build upon the strong efficacy seen in the Phase 1 study. We believe there are three factors that could drive our PFS even higher than the 8.7 months observed in the Phase 1 monotherapy trial.

投影片 13 強調了我們為何對第 2 階段研究在第 1 階段研究中看到的強大功效的基礎上進一步發展的潛力如此樂觀。我們認為有三個因素可以推動我們的 PFS 甚至高於第 1 階段單藥治療試驗中觀察到的 8.7 個月。

First, preliminary evidence of an exposure-response relationship allows us to focus our Phase 2 study on three of the highest tolerated doses from the Phase 1 dose escalation and expansion study. Second, utilizing primary prophylaxis with UCSF to combat neutropenia potentially allows patients more consistent exposure to the ADC with fewer dose interruptions or adjustments.

首先，暴露-反應關係的初步證據使我們能夠將第 2 階段研究重點放在第 1 階段劑量遞增和擴展研究中的三個最高耐受劑量。其次，利用 UCSF 進行一級預防來對抗嗜中性白血球減少症，可能使患者能夠更持續地接觸 ADC，減少劑量中斷或調整。

Third, enrolling patients in earlier lines of therapy versus the median five prior lines of therapy in the Phase 1 trial. We believe that these design elements have the potential to improve upon the Phase 1 results and achieve an rPFS in the 10 to 12-month range, which we believe is the benchmark for commercial competitiveness.

第三，招募患者接受早期治療方案，而非第一階段試驗中位數為五種先前治療方案。我們相信這些設計元素有可能改善第一階段的結果，並在 10 到 12 個月的範圍內實現 rPFS，我們相信這是商業競爭力的基準。

On slide 14. We show our long-term development strategy for FG-3246 and FG-3180, which we believe provides significant optionality in prostate cancer. We have a robust Phase 2 monotherapy trial in the pre-chemo setting in mCRPC to further build upon the compelling efficacy data of 8.7 months of rPFS in 40 heavily pretreated biomarker-unselected patients from the Phase 1 monotherapy study.

在第 14 張投影片上。我們展示了 FG-3246 和 FG-3180 的長期發展策略，我們相信這為前列腺癌的治療提供了重要的選擇。我們在 mCRPC 的化療前環境中進行了一項強有力的 2 期單藥治療試驗，以進一步鞏固 1 期單藥治療研究中 40 名接受過大量預處理且生物標誌物未選擇的患者 8.7 個月 rPFS 的令人信服的療效數據。

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

此外，本研究將探討 CD46 表現與 ADC 反應之間的相關性，可能在未來的研究中驗證 FG-3180 作為預測患者選擇生物標記。我們相信，FG-3246 的開發路徑將解鎖連續或並行的註冊路徑，因為 FG-3246 將在單一療法和/或與 ARSI 聯合治療的多種療法中進行評估，並且適用於所有人群或 CD46 高表達的患者。

Slide 15 shows the recent and upcoming catalysts for the FG-3246 and FG-3180 program. We are very pleased to have received IND clearance for FG-3180, as this marks an important milestone as we explore its potential to be used as a diagnostic tool and potential biomarker for patient selection in the treatment of mCRPC. We plan to initiate the Phase 2 monotherapy trial in the third quarter, which will include FG-3180 to enable assessment of its diagnostic performance and the potential correlation between CD46 expression and response to FG-3246.

幻燈片 15 展示了 FG-3246 和 FG-3180 計劃的近期和即將推出的催化劑。我們非常高興 FG-3180 獲得 IND 批准，這標誌著我們探索其作為 mCRPC 治療中的診斷工具和患者選擇的潛在生物標記的潛力的一個重要里程碑。我們計劃在第三季啟動 2 期單藥治療試驗，其中將包括 FG-3180，以評估其診斷性能以及 CD46 表達與對 FG-3246 的反應之間的潛在相關性。

To summarize on slide 16, FG-3246 targets a novel epitope on prostate cancer cells with first-in-class potential. It is important to note that 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. We are excited for the upcoming milestones and look forward to updating you on the program as the studies progress.

如幻燈片 16 所示，FG-3246 針對前列腺癌細胞上的新表位，具有一流的潛力。值得注意的是，目前尚無其他針對 CD46 的項目處於臨床開發階段。使用 FG-3246 靶向 CD46 已經顯示出良好的早期療效信號，並且在單一療法和聯合療法中均具有可接受的安全性。我們對即將到來的里程碑感到興奮，並期待隨著研究的進展向您更新該計劃。

Turning to roxadustat, slide 18 highlights the unmet need and the potential for roxadustat in patients with anemia associated with lower-risk MDS. There is a lack of effective second-line and beyond treatments, given that the currently available therapies are only effective in approximately 50% of patients. In addition, there are no oral options available or in late-stage development, which could be a meaningful differentiator for roxadustat and potentially translate into a significant commercial opportunity.

談到羅沙司他，幻燈片 18 強調了未滿足的需求以及羅沙司他對於低風險 MDS 相關貧血患者的潛力。由於目前可用的療法僅對約 50% 的患者有效，因此缺乏有效的二線及以上治療方法。此外，目前還沒有口服藥物可供選擇或處於後期開發階段，這可能是羅沙司他的一個重要的區別因素，並可能轉化為一個重要的商業機會。

Moving on to slide 19, we highlight data from the Phase 3 MATTERHORN study of roxadustat in a subgroup of patients with anemia of lower-risk MDS who entered the trial with a higher transfusion burden. In this post hoc analysis, roxadustat demonstrated a meaningful difference in transfusion independence versus placebo, results that are highly similar to the pivotal trials for two recently approved therapies for anemia associated with lower-risk MDS.

轉到幻燈片 19，我們重點介紹了羅沙司他在第 3 階段 MATTERHORN 研究中的數據，該研究針對的是一組患有低風險 MDS 貧血且在試驗開始時輸血負擔較高的患者。在本次事後分析中，羅沙司他與安慰劑相比在輸血獨立性方面表現出顯著差異，其結果與最近批准的兩種針對低風險 MDS 相關貧血療法的關鍵試驗結果高度相似。

On slide 20, we highlight the significant opportunity for roxadustat in lower-risk MDS. Based on other lower-risk MDS development programs, we believe the indication would support an orphan drug designation, which would provide seven years of data exclusivity in the US. This potential exclusivity, combined with an attractive market opportunity and efficient commercial model, provides a significant economic opportunity for further development of roxadustat. We look forward to near-term discussions with the FDA, which could pave the way for developing roxadustat for anemia associated with lower-risk MDS on our own or through a potential partnership.

在第 20 張投影片上，我們重點介紹了羅沙司他在低風險 MDS 領域的巨大機會。根據其他低風險 MDS 開發計劃，我們認為該適應症將支持孤兒藥稱號，這將在美國提供七年的數據獨佔權。這種潛在的排他性，加上誘人的市場機會和高效的商業模式，為羅沙司他的進一步發展提供了重要的經濟機會。我們期待與 FDA 進行近期討論，這可能為我們自行或透過潛在合作夥伴開發用於治療低風險 MDS 相關貧血的羅沙司他鋪平道路。

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

說完這些，我現在將電話轉給戴夫，討論公司的財務狀況。戴夫？

Thank you, Thane. I will first review the updated FibroGen China transaction details and then provide the company's financial performance for the first quarter of 2025. As a reminder, our China operations are reflected as discontinued operations throughout our financials. We will continue to report our China operations in continued operations moving forward.

謝謝你，Thane。我將首先審查更新的 FibroGen China 交易細節，然後提供該公司 2025 年第一季的財務表現。提醒一下，我們的中國業務在我們的整個財務報表中被反映為已停止的業務。我們將在未來的持續營運中繼續報告我們的中國業務。

On slide 22, we highlight the summary of key financial terms of the transaction. Under the terms of the agreement, FibroGen will receive an enterprise value of $85 million plus FibroGen net cash held in China at closing, estimated to now be approximately $100 million, totaling approximately $185 million. This is a $25 million increase from our initial net cash guidance in February. Given the company's current market capitalization of approximately $30 million, we believe this increase in expected net cash received upon the close of the transaction represents a meaningful outcome for shareholders.

在第 22 張投影片上，我們重點介紹了交易的關鍵財務條款摘要。根據協議條款，FibroGen 將獲得 8,500 萬美元的企業價值，加上交易完成時 FibroGen 在中國持有的淨現金（目前估計約 1 億美元），總計約 1.85 億美元。這比我們二月最初的淨現金預期增加了 2500 萬美元。鑑於該公司目前的市值約為 3000 萬美元，我們相信交易結束時預期收到的淨現金的增加對股東來說是一個有意義的結果。

As a reminder, the value of FibroGen net cash in China includes FibroGen's portion of Falikang net cash, which is the joint distribution entity owned by FibroGen and AstraZeneca. Importantly, FibroGen will continue to accrue cash generated in China until the closing of the transaction, which is expected in the third quarter of 2025, pending customary closing conditions including regulatory review in China.

需要提醒的是，FibroGen 在中國的淨現金價值包括 FibroGen 在法利康淨現金中所佔的份額，法利康是 FibroGen 和阿斯特捷利康共同擁有的聯合分銷實體。重要的是，FibroGen 將繼續累積在中國產生的現金，直到交易完成，預計在 2025 年第三季度，但需滿足包括中國監管審查在內的慣例成交條件。

This transaction is truly transformative for FibroGen and allows the company to pay down its senior term loan facility with MSTV, fully access our cash in China, and extend the company's runway into the second half of 2027 to support US development initiatives.

這項交易對 FibroGen 來說具有真正的變革意義，使公司能夠償還 MSTV 的優先定期貸款，充分利用我們在中國的現金，並將公司的營運延長至 2027 年下半年，以支持美國的發展計畫。

Now, on to the company's financials for the first quarter. For the first quarter of 2025, total revenue was $2.7 million compared to $25.4 million for the same period in 2024. For the full year 2025, we reiterate total revenue to be between $4 million and $8 million.

現在，我們來看看該公司第一季的財務狀況。2025 年第一季總營收為 270 萬美元，而 2024 年同期為 2,540 萬美元。對於 2025 年全年，我們重申總收入將在 400 萬美元至 800 萬美元之間。

Now, moving down the income statement, total operating costs and expenses for the first quarter of 2025 were $17.7 million compared to $74.5 million for the first quarter of 2024, a decrease of $56.8 million or 76% year-over-year. R&D expenses for the first quarter of 2025 were $9.2 million compared to $36.5 million in the first quarter of 2024, a decrease of $27.3 million or 75% year-over-year. SG&A expenses for the first quarter of 2025 were $8.1 million compared to $16.7 million in the first quarter of 2024, a decrease of $8.6 million or 51% year-over-year.

現在，沿著損益表往下看，2025 年第一季的總營運成本和費用為 1,770 萬美元，而 2024 年第一季為 7,450 萬美元，年減 5,680 萬美元，即 76%。2025 年第一季的研發費用為 920 萬美元，而 2024 年第一季為 3,650 萬美元，年減 2,730 萬美元，降幅為 75%。2025 年第一季的銷售、一般及行政費用為 810 萬美元，而 2024 年第一季為 1,670 萬美元，年減 860 萬美元，降幅為 51%。

During the first quarter of 2025, we recorded a net loss from continuing operations of $16.8 million or $0.16 net loss per basic and diluted share, as compared to a net loss of $49 million or $0.49 per basic and diluted share for the first quarter of 2024. For the full year 2025, we reiterate our guidance for our total operating costs and expenses, including stock-based compensation, to be between $70 million and $80 million, which at the midpoint represents a 58% reduction from the full year 2024.

2025 年第一季度，我們錄得持續經營淨虧損 1,680 萬美元，即每股基本虧損和稀釋虧損均為 0.16 美元，而 2024 年第一季的淨虧損為 4,900 萬美元，即每股基本虧損和稀釋虧損均為 0.49 美元。對於 2025 年全年，我們重申總營運成本和費用（包括股票薪酬）的預期，在 7,000 萬美元至 8,000 萬美元之間，中間值比 2024 年全年減少 58%。

Now, shifting towards cash, as of December 31, we reported $33.8 million in cash, cash equivalents, and accounts receivable in the US, and $128.4 million in total consolidated cash, cash equivalents, and accounts receivable when including balances in China. The company was cash flow positive in the first quarter of 2025, generating a total of $7.3 million in cash flow on a total consolidated basis when including balances in China.

現在，轉向現金，截至 12 月 31 日，我們報告稱在美國擁有 3,380 萬美元的現金、現金等價物和應收帳款，包括中國餘額後，合併現金、現金等價物和應收帳款總額為 1.284 億美元。該公司在 2025 年第一季的現金流為正，包括中國餘額後，以合併口徑總計產生了 730 萬美元的現金流。

Given that the company will continue to accrue cash from its China operations until the close of the sale transaction, we expect the company to again be cash flow positive on a consolidated basis in the second quarter of 2025. Upon close of the China transaction, we plan to pay off our senior secured term loan with Morgan Stanley Tactical Value, resulting in a cash outflow of approximately $80 million. This includes the $75 million principal balance, accrued and unpaid interest, and an applicable prepayment penalty. Post the payoff of our MSTV term loan, we expect the company to have runway into the second half of 2027.

鑑於該公司在出售交易結束前將繼續從其中國業務中累積現金，我們預計該公司在 2025 年第二季的合併現金流量將再次為正。中國交易完成後，我們計劃償還摩根士丹利戰術價值的優先擔保定期貸款，這將產生約 8,000 萬美元的現金流出。其中包括 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。在償還 MSTV 定期貸款後，我們預計公司將在 2027 年下半年順利實現盈利。

Thank you, and we'll now turn the call back over to Thane.

謝謝，現在我們將電話轉回給 Thane。

Thank you, Dave. To conclude, we are extremely excited about the future prospects for FibroGen with a number of important catalysts in the coming months. We plan to advance our exciting pipeline, initiating the Phase 2 monotherapy study next quarter for FG-3246 and FG3-180 in mCRPC. We will gain important feedback from the FDA regarding the potential development of roxadustat in lower-risk MDS, and we anticipate the close of the FibroGen China sale, payoff of the MSTV term loan, and extension of our cash runway into the second half of 2027.

謝謝你，戴夫。總而言之，我們對 FibroGen 的未來前景感到非常興奮，未來幾個月將出現許多重要的催化劑。我們計劃推進我們令人興奮的產品線，下個季度啟動針對 mCRPC 的 FG-3246 和 FG3-180 的 2 期單藥治療研究。我們將從 FDA 獲得有關羅沙司他在低風險 MDS 中的潛在開發的重要反饋，我們預計 FibroGen 中國銷售的完成、MSTV 定期貸款的償還以及現金流的延長將在 2027 年下半年完成。

In summary, we are committed to driving significant shareholder value by advancing our US development initiatives, supported by our strong balance sheet. We look forward to providing further updates to our stakeholders over the coming months.

總而言之，我們致力於透過推動美國發展計畫並在強勁的資產負債表的支持下，為股東創造巨大價值。我們期待在未來幾個月內向我們的利害關係人提供進一步的更新。

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

現在我想將電話轉給接線員進行問答。

(Operator Instructions) Andy Hsish, William Blair.

（操作員指示）Andy Hsish，William Blair。

Thanks for taking our questions. Congratulations on the higher-than-expected proceeds from the AstraZeneca deal and the JCO publication. So, we have three questions. One has to do with clinical development on FG-3246 and so this has to do with some of the market dynamic changes after the Pluvicto approval based on the PSMA 4 study in the pre-chemo setting.

感謝您回答我們的問題。恭喜阿斯特捷利康交易和 JCO 出版物的收益高於預期。因此，我們有三個問題。其中一個與 FG-3246 的臨床開發有關，因此這與 Pluvicto 核准後（基於化療前環境中的 PSMA 4 研究）的一些市場動態變化有關。

I'm curious if you have contemplated potentially running the monotherapy study or the pivot program in the Pluvicto experienced population just to mitigate some of the risk associated with a highly heterogeneous population and maybe targeting a higher unmet medical need. So, that's question number one.

我很好奇，您是否考慮過在 Pluvicto 經驗豐富的人群中進行單一療法研究或關鍵計劃，只是為了減輕與高度異質性人群相關的一些風險，並可能針對更高的未滿足的醫療需求。這是第一個問題。

Question number two, has to do with some of the macro disruptions that we have read about in the news or reported by the media. I'm just curious if you can comment on some of the recent FDA correspondence or communication, especially with the Roxadustat study and the opportunity.

第二個問題與我們在新聞中讀到或媒體報導的一些宏觀動盪有關。我只是好奇您是否可以對最近的一些 FDA 信函或交流發表評論，特別是有關 Roxadustat 的研究和機會。

And third, I think this is something you have mentioned a couple of times in previous calls. Given the cash infusion from AstraZeneca, is it worthwhile, maybe from a capital allocation perspective, to conduct some feasibility studies in colorectal cancer, especially in light of [CytomX's] success this morning? Thank you very much

第三，我認為這是您在之前的通話中提到過幾次的事情。鑑於阿斯特捷利康的現金注入，從資本配置的角度來看，對結直腸癌進行一些可行性研究是否值得，尤其是考慮到今天上午 [CytomX] 的成功？非常感謝

Hey, thanks, Andy, for the comments and the questions. Appreciate that. So, let me touch on the first one and then I'll ask Dave to comment as well. As it relates to clinical development for FG-3246 and some market dynamic changes with Pluvicto's new indication, as part of our synopsis or protocol for the Phase 2 monotherapy trial, we are going to allow Pluvicto experienced patients who happen to progress while on Pluvicto in that pre-chemo or post-ARSI pre-chemo setting to be entered into our trial.

嘿，安迪，謝謝你的評論和問題。非常感謝。那麼，讓我先談談第一個問題，然後我會請戴夫也發表評論。由於它與 FG-3246 的臨床開發以及 Pluvicto 新適應症的一些市場動態變化有關，作為我們第 2 階段單藥治療試驗概要或方案的一部分，我們將允許在化療前或 ARSI 化療後使用 Pluvicto 期間病情出現進展的 Pluvicto 經驗豐富的患者參加我們的試驗。

We don't think it makes sense to only or exclusively study those patients who are post-Pluvicto because, as I'm sure you can appreciate, Andy, you never have rapid adoption of an agent with a new indication. It usually takes time for clinicians to begin to adopt it.

我們認為，只研究或專門研究那些接受 Pluvicto 治療的患者是沒有意義的，因為，安迪，我相信你能理解，你永遠不會迅速採用一種具有新適應症的藥物。臨床醫生通常需要一些時間才能開始接受它。

So, if we would require all patients who would be entered into our Phase 2 monotherapy trial to have been Pluvicto experienced, we just think that would create too much of an enrollment challenge. But we will be allowing patients who have been treated with Pluvicto to be entered into our Phase 2 monotherapy trial. Dave, anything to add to that?

因此，如果我們要求所有參加第 2 階段單藥治療試驗的患者都接受過 Pluvicto 治療，我們認為這會對入組造成太大的挑戰。但我們將允許接受過 Pluvicto 治療的患者參加我們的第 2 期單一療法試驗。戴夫，還有什麼要補充的嗎？

Nothing to add there, thanks.

沒什麼好補充的，謝謝。

Okay, and then in terms of the macro news and a lot of what's going on with respect to (inaudible) and FDA and the like, the only thing that we can point to are recent interactions that we've had with the agency. Maybe I'll give you just a flavor of that.

好的，就宏觀新聞和與（聽不清楚）和 FDA 等有關的許多事情而言，我們唯一可以指出的是我們最近與該機構的互動。也許我會讓你稍微體會一下。

The first one was when we filed the IND for FG-3180, which is our PET imaging agent. Everything progressed exactly on schedule. The questions, there were just a few of them, they came in a timely way. We answered them, the IND got cleared right on time.

第一個是我們提交了 FG-3180（這是我們的 PET 造影劑）的 IND。一切都按計畫順利進行。問題只有幾個，而且來得非常及時。我們答覆了他們，IND 準時得到了批准。

The next example that we have for the agency was the reactivation of the roxadustat IND in the US. We had deactivated it once we got the license back from AZ a little over a year ago. We needed to reactivate it in order to file the Type C meeting request. We requested the reactivation, that was also achieved right on time.

我們為該機構提供的下一個例子是在美國重新啟動羅沙司他 IND。一年多前，我們從 AZ 拿回許可證後就將其停用了。我們需要重新啟動它才能提交 C 類會議請求。我們請求重新激活，這也及時完成了。

And then in terms of the Type C meeting request that we filed, typically the FDA has 21 days or so to get back to the sponsor once a Type C meeting request has been filed. If they accept the Type C meeting request, there is then a date that has been set. We filed that Type C meeting request a week ago and have already heard back from the agency on the date that the Type C meeting is set for. So, the experiences that we have, Andy, I think are very favorable in terms of the FDA continuing to keep to certain timelines. In fact, we haven't experienced anything that's different than that.

就我們提交的 C 類會議請求而言，通常情況下，一旦提交了 C 類會議請求，FDA 有大約 21 天的時間回覆發起人。如果他們接受 C 類會議請求，則會確定日期。我們在一週前提交了 C 類會議請求，並且已經收到了該機構關於 C 類會議召開日期的回應。因此，安迪，我認為我們的經驗對於 FDA 繼續遵守某些時間表非常有利。事實上，我們並沒有經歷過任何與此不同的事情。

And then finally, in terms of cash from AZ and potentially doing a feasibility study for FG-3246 in mCRPC, I think we're going to hold off on that for now. We continue to evaluate lifecycle opportunities. The most important thing that we need to do is get the Phase 2 monotherapy trial started and then we'll be evaluating other opportunities that we think make sense from a lifecycle perspective.

最後，就來自 AZ 的現金以及可能對 FG-3246 在 mCRPC 中進行的可行性研究而言，我認為我們暫時不會這麼做。我們將繼續評估生命週期機會。我們需要做的最重要的事情是開始第二階段單一療法試驗，然後我們將從生命週期的角度評估我們認為有意義的其他機會。

Dave, anything to add to that?

戴夫，還有什麼要補充的嗎？

No, I think you hit the nail on the head there, Thane. I think for us, obviously, we have identified colorectal cancer as a potential opportunity for FG-3246 given the expression of CD46 in those patients. But at the same point, I think our goals for this calendar year are really to close the transaction for China, kick off our Phase 2 studies, and really get the ball rolling around the development pathway for roxadustat in MDS as well. So, great question, Andy.

不，我認為你說到了點子上了，Thane。我認為，對我們來說，顯然，鑑於這些患者體內 CD46 的表達，我們已經將結直腸癌確定為 FG-3246 的潛在機會。但同時，我認為我們今年的目標實際上是完成中國的交易，啟動我們的第二階段研究，並真正推動羅沙司他治療 MDS 的開發進程。所以，安迪，這個問題問得好。

Great, thank you so much.

太好了，非常感謝。

Any other follow-up questions, Andy?

還有其他後續問題嗎，安迪？

I think that's it from us. Thank you so much.

我想我們就這些了。太感謝了。

Okay. Yeah, thanks for the questions. Appreciate it.

好的。是的，謝謝你的提問。非常感謝。

(Operator Instructions) Matthew Keller, HCW.

（操作員指示）Matthew Keller，HCW。

Hey everyone, congrats on the quarter and thanks for taking our questions. Just two quick ones from us. The first one, I was wondering if you have any additional or any rate-limiting steps ahead of the upcoming Phase 2 monotherapy study?

大家好，恭喜本季取得佳績，感謝您回答我們的問題。我們只想簡單說兩句話。第一個問題，我想知道在即將進行的第二階段單一療法研究之前，您是否有任何額外或任何限速措施？

And then secondly, with the updates on today's call, I was wondering how we should start to view the evolving commercial opportunity for FG-3180?

其次，根據今天電話會議的最新消息，我想知道我們應該如何開始看待 FG-3180 不斷發展的商業機會？

Thanks, Matt, for the questions. I'll take them and then ask Dave to add some additional commentary as well. Originally, as it relates to the Phase 2 monotherapy trial, we weren't certain how quickly we were going to get the FG-3180 IND cleared. So, there was a point in time where we thought that the majority of the patients in the Phase 2 monotherapy trial, the 75 patients, would be able to be treated with the PET biomarker in addition to the ADC.

謝謝馬特提出的問題。我會接受它們，然後讓戴夫也添加一些額外的評論。最初，由於它與第 2 階段單一療法試驗有關，我們不確定我們將多快獲得 FG-3180 IND 的批准。因此，我們曾一度認為，第 2 期單藥治療試驗中的大多數患者（75 名患者）除了 ADC 之外，還可以接受 PET 生物標記治療。

Now, with the clearing of the IND, I wouldn't call it a rate limiter, but what that allows us to do is to get an amendment in front of the sites that includes FG-3180 as part of the Phase 2 monotherapy study. So that all of the patients in the Phase 2 trial will be able to be treated with the PET biomarker in advance of receiving the ADC. We're going through that process right now as we speak.

現在，隨著 IND 的批准，我不會稱之為限速器，但它使我們能夠在站點前進行修訂，將 FG-3180 納入第 2 階段單一療法研究的一部分。這樣，第 2 階段試驗中的所有患者都能夠在接受 ADC 之前接受 PET 生物標記的治療。我們現在就在經歷這個過程。

The rate limiter is the close of the China transaction so that we can move forward rapidly to then start the Phase 2 monotherapy trial. In terms of the question around the evolving landscape, what was that one question again?

限速器是中國交易的結束，這樣我們就可以快速前進，然後開始第二階段單藥療法試驗。關於景觀演變的問題，那個問題又是什麼？

Kind of like how we should view the commercial opportunity for FG-3180 as it evolves, both as a stand-alone product or in combination with some of the other things you guys have going on as well.

這有點像我們應該如何看待 FG-3180 在發展過程中的商業機會，既可以將其作為獨立產品，也可以將其與你們正在進行的其他一些產品相結合。

Yeah, it's a really important question. The Phase 2 trial will tell us a lot. It will give us even more information relative to what we have now. There have been about 25 or 27 patients who have been treated with the PET imaging agent in the Phase 1/2 investigator-sponsored trial at UCSF in combination with enzalutamide. We've seen those scans. It's clear that the target lights up with the PSMA imaging agent, and as you know, it uses the same YS5 antibody that is part of the ADC. The scans look really clear.

是的，這是一個非常重要的問題。第二階段試驗將會告訴我們很多。它將為我們提供更多與現有資訊相關的資訊。在加州大學舊金山分校由研究人員發起的 1/2 期試驗中，大約有 25 或 27 名患者接受了 PET 造影劑與恩雜魯胺聯合治療。我們已經看過那些掃描結果了。很明顯，目標被 PSMA 成像劑照亮，並且如您所知，它使用與 ADC 一部分相同的 YS5 抗體。掃描結果看起來非常清晰。

The Phase 2 trial will then tell us if we continue to see the scans appropriately light up the lesions and what we can learn in terms of the assessment of the expression level of CD46 in response to the ADCs. That will be a correlation analysis that we will do during the course of the trial and at the end of the trial so that we can understand the diagnostic performance of the agent itself.

然後，第 2 階段試驗將告訴我們是否繼續看到掃描適當地照亮病變，以及我們可以從對 ADC 反應的 CD46 表達水平的評估中學到什麼。我們將在試驗期間和試驗結束時進行相關性分析，以便我們了解藥物本身的診斷效能。

We have looked at the radioligand space, we've looked at the PSMA PET space. Clearly, with the PSMA PET imaging agents from Lantheus and from Telix that generate well over $1.5 billion in annual revenue, there is a clear commercial opportunity. But we're going to have to assess the performance of our PET imaging agent to determine what that potential commercial opportunity could be.

我們研究了放射性配體空間，我們研究了 PSMA PET 空間。顯然，Lantheus 和 Telix 的 PSMA PET 造影劑每年可產生超過 15 億美元的收入，這其中蘊含著明顯的商業機會。但我們必須評估 PET 造影劑的性能，以確定潛在的商業機會是什麼。

Dave, please add to that.

戴夫，請補充一下。

Yeah, I think the one thing that I want to add around the Phase 2 and the importance of being able to dose all 75 patients is that we're really trying to get to a point where we can have a large swath of patients being able to be tested with FG-3180. The fact that we could have 75 patients in the Phase 2, we have the Phase 2 portion of the combination therapy and the IST with UCSF.

是的，我想補充一點，關於第 2 階段以及能夠為所有 75 名患者進行給藥的重要性是，我們確實希望達到能夠讓大量患者接受 FG-3180 測試的程度。事實上，我們在第 2 階段可以有 75 名患者，我們有聯合療法的第 2 階段部分以及與 UCSF 合作的 IST。

The more and more patients that we can get treated with FG-3180 allows us to get really smart around what the levels of expression would be that could correlate with efficacy and allows us to better understand how it can be used in future studies.

使用 FG-3180 治療的患者數量越多，我們就越能了解與療效相關的表達水平，也就越能理解如何在未來的研究中使用它。

Yep, no, totally makes sense. Thanks again for taking our questions. Appreciate you guys.

是的，不，完全有道理。再次感謝您回答我們的問題。感謝你們。

Thank you, Matt.

謝謝你，馬特。

I'm not showing any further questions at this time. I turn the call back over to Thane for closing remarks.

我目前沒有其他問題。我把電話轉回給 Thane，請他做最後發言。

We appreciate everybody's participation today and continued interest in FibroGen. We look forward to updating you over the coming weeks and months on the important catalysts that are ahead of us. Thank you for your time today.

我們感謝大家今天的參與以及對 FibroGen 的持續關注。我們期待在未來幾週和幾個月內向您通報我們面臨的重要催化劑。感謝您今天抽出時間。

Ladies and gentlemen, this concludes today's presentation. You may now disconnect and have a wonderful day.

女士們、先生們，今天的演講到此結束。現在您可以斷開連接並享受美好的一天。