Kyntra Bio, Inc. (KYNB) 2026 Q1 法說會逐字稿

Good day, and thank you for standing by. Welcome to the Kyntra Bio first-quarter 2026 earnings conference call. (Operator Instructions) Please be advised that today's call is being recorded.

各位好，感謝您稍候。歡迎參加 Kyntra Bio 2026 年第一季財報電話會議。（接線員指示）請注意，今天的電話會議將被錄音。

I would now like to hand it over to our first speaker, Gaia Shamis. Please go ahead.

現在我想把時間交給我們的第一位講者 Gaia Shamis。請開始。

Thank you, Victor. Good afternoon, everyone, and thank you for joining us today to discuss Kyntra Bio's first-quarter 2026 financial and business results. I'm Gaia Shamis from LifeSci Advisors.

謝謝你，Victor。各位下午好，感謝大家今天加入我們，一同討論 Kyntra Bio 2026 年第一季的財務與業務成果。我是 LifeSci Advisors 的 Gaia Shamis。

Joining me on today's calls are Thane Wettig, Chief Executive Officer; David DeLucia, Chief Financial Officer; and Carol Gaddum, Vice President of Product Development. Following the prepared remarks, we will open the call to your questions.

今天與我一同出席電話會議的有：執行長 Thane Wettig；財務長 David DeLucia；以及產品開發副總裁 Carol Gaddum。在事先準備的發言結束後，我們將開放提問。

I would like to remind you that remarks made on today's call include forward-looking statements about Kyntra Bio. Such statements may include, but are not limited to, collaborations 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，今天電話會議中的發言包含關於 Kyntra Bio 的前瞻性陳述。此類陳述可能包括但不限於：與 AstraZeneca 與 Astellas 的合作；財務指引；臨床試驗的啟動、收案、設計、執行與結果；法規策略與潛在法規結果；研發活動；商業成果與營運結果；與我們業務相關的風險；以及其他若干業務事項。

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, and our complete description of these and other material risks can be found in Kyntra Bio filing with the SEC, including our most recent Form 10-K and Form 10-Q.

每一項前瞻性陳述均受風險與不確定性影響，可能導致實際結果與事件與該等陳述中的預期存在重大差異。我們對這些及其他重大風險的完整說明，載於 Kyntra Bio 向美國證券交易委員會（SEC）提交的文件中，包括我們最新的 Form 10-K 與 Form 10-Q。

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

Kyntra Bio 不承擔公開更新任何前瞻性陳述的義務，不論係因新資訊、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 Kyntra Bio website at www.kyntrabio.com.

公司財務結果與業務更新的新聞稿，以及今日電話會議的網路直播，可於 Kyntra Bio 官網 www.kyntrabio.com 的「投資人」專區查閱。

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

接下來，我想把電話會議交給執行長 Thane Wettig。Thane？

Thank you, Gaia. Good afternoon, everyone, and welcome to our first-quarter 2026 earnings call.

謝謝你，Gaia。各位下午好，歡迎參加我們 2026 年第一季財報電話會議。

On today's call, I will provide an update on the consistent progress we have made across our portfolio. First, with FG-3246, our potential first-in-class antibody-drug conjugate targeting CD46 and its companion PET imaging agent in metastatic castration-resistant prostate cancer; and second, with roxadustat, our potential treatment for anemia due to lower-risk mild dysplastic syndromes. Then David DeLucia, our CFO, will review the financials, after which we will open the call for your questions.

在今天的電話會議中，我將就我們在產品組合各項計畫上所取得的持續進展提供最新資訊。第一，FG-3246：我們潛在同類首創（first-in-class）、以 CD46 為標的的抗體藥物複合體（ADC），以及其在轉移性去勢抗性前列腺癌中的配套 PET 影像顯影劑；第二，roxadustat：我們用於治療因低風險輕度骨髓增生不良症候群所致貧血的潛在療法。接著，我們的財務長 David DeLucia 將回顧財務表現，之後我們將開放提問。

Starting with slide 3, I'd like to highlight our mid- and late-stage programs and upcoming catalysts. FG-3246 and FG-3180 are two exciting assets that are currently being evaluated in a Phase 2 monotherapy trial in the post-ARPI pre-chemo setting in metastatic castration-resistant prostate cancer, where we are actively enrolling patients at multiple sites in the US anticipated interim analysis in the fourth quarter of 2026.

從投影片 3 開始，我想重點說明我們的中後期計畫與即將到來的催化劑。FG-3246 與 FG-3180 是兩項令人振奮的資產，目前正在一項第二期單藥試驗中評估，試驗族群為轉移性去勢抗性前列腺癌在 ARPI 後、化療前的治療情境；我們正於美國多個中心積極收案，並預計於 2026 年第四季進行期中分析。

Roxadustat, which received orphan drug designation in lower-risk myelodysplastic syndromes at the end of last year, is advancing as planned. We recently received constructive feedback from the FDA on the Phase 3 design and are in the process of finalizing the protocol. As we have stated previously, we expect to initiate the Phase 3 trial in the second half of 2026.

Roxadustat 於去年年底在低風險骨髓增生不良症候群獲得孤兒藥資格認定，目前依計畫推進。我們近期自 FDA 收到對第三期試驗設計具建設性的回饋，並正進行方案定稿。如同先前所述，我們預期於 2026 年下半年啟動第三期試驗。

On the heels of our transformation over the past two years, we are laser-focused on continued execution of our strategy with upcoming catalysts for both clinical programs, a simplified capital structure, and a cash runway into 2028.

在過去兩年完成轉型之後，我們將持續聚焦於策略執行：兩項臨床計畫皆有即將到來的催化劑、資本結構更為簡化，且現金可支應營運至 2028 年。

Moving to our FG-3246 and FG-3180 program in mCRPC, where we believe significant opportunity exists to bring a new treatment for the 65,000 men in the US diagnosed every year with drug-treatable castration-resistant metastatic disease.

接著談到我們在 mCRPC 的 FG-3246 與 FG-3180 計畫；我們相信此領域存在顯著機會，可為美國每年約 65,000 名被診斷為可藥物治療之去勢抗性轉移性疾病的男性帶來新的治療選擇。

Slide 5 captures the uniqueness of CD46, a tumor-selective, multifunctional target that helps tumors evade complement-dependent cytotoxicity. While there are a number of non-PSMA tumor antigen targets for metastatic prostate cancer, there are important characteristics of CD46 that distinguish it from these other targets.

投影片 5 呈現 CD46 的獨特性：這是一個腫瘤選擇性、多功能的標的，可協助腫瘤逃避免疫補體依賴性細胞毒殺（complement-dependent cytotoxicity）。雖然針對轉移性前列腺癌存在多種非 PSMA 的腫瘤抗原標的，但 CD46 具備若干重要特性，使其有別於其他標的。

First, CD46 is highly expressed in prostate cancer and other tumors with limited expression in normal tissue. In addition, CD46 is upregulated during tumorigenesis, as well as during the progression from localized castration-sensitive prostate cancer to metastatic castration-resistant prostate cancer. Further, it is estimated that 50% to 70% of patients have high CD46-expressing tumors.

首先，CD46 在前列腺癌及其他腫瘤中高度表現，而在正常組織中的表現有限。此外，CD46 在腫瘤生成過程中會上調，並且在疾病由局部去勢敏感性前列腺癌進展至轉移性去勢抗性前列腺癌的過程中亦會上調。再者，估計有 50% 至 70% 的患者腫瘤具有高 CD46 表現。

Finally, CD46 is expressed more homogenously with lower interpatient variability and with higher median expression in mCRPC tissues compared with PSMA, making it an attractive non-PSMA therapeutic target.

最後，相較於 PSMA，CD46 的表現更為均一、病人間變異較低，且在 mCRPC 組織中的中位表現量更高，使其成為具吸引力的非 PSMA 治療標的。

Turning to slide 6, FG-3246 is our CD46-targeting 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, whose expression is limited in normal tissue.

接著看投影片 6，FG-3246 是我們正在開發、以 CD46 為標的、用於 mCRPC 的潛在同類首創 ADC。此 ADC 結合 YS5 抗體與 MMAE 載荷（payload），以特異性鎖定 CD46 的腫瘤選擇性表位，而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. In addition, the MMAE payload is clinically and commercially validated serving as the payload for five currently marketed ADCs that in 2025, generated approximately $5 billion in worldwide revenue.

FG-3246 代表一種不依賴雄性素受體（androgen receptor agnostic）的策略，使其在臨床上有別於其他目前開發中的前列腺癌療法，其中許多以 PSMA 為標的。此外，MMAE 載荷已在臨床與商業上獲得驗證，作為目前已上市五款 ADC 的載荷；這些產品於 2025 年合計創造約 50 億美元的全球營收。

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

配套的 PET 影像顯影劑 FG-3180 使用與 FG-3246 相同的 YS5 標的抗體，亦以其自身獨立的 IND 進行臨床開發。我們相信，若能具備用於病人篩選的生物標記，不僅可在未來第三期試驗中更有效地富集適合的病人族群，也可使 FG-3246 在前列腺癌治療版圖中形成差異化。

In addition, FG-3180 could represent an important commercial opportunity as a companion diagnostic to FG-3246, similar to the existing PSMA PET agents, which generated revenue of almost $2 billion in 2025.

此外，FG-3180 作為 FG-3246 的配套診斷（companion diagnostic）也可能代表重要的商業機會，類似於現有的 PSMA PET 顯影劑；後者在 2025 年創造了近 20 億美元的營收。

Our development strategy aims to achieve a clinically differentiated profile in a competitive yet highly unsatisfied mCRPC market. Importantly, we're the only non-PSMA program in mid- to late-stage development that combines a therapeutic with a companion PET imaging agent.

我們的開發策略旨在競爭激烈但高度未被滿足的 mCRPC 市場中，建立具臨床差異化的產品特性。重要的是，我們是唯一一個處於中後期開發、且將治療藥物與配套 PET 影像顯影劑結合的非 PSMA 計畫。

I will now recap the clinical results for FG-3246 across two distinct trials.

接下來，我將回顧 FG-3246 在兩項不同試驗中的臨床結果。

Starting with the Phase 1 monotherapy trial, slide 7 recaps the encouraging top-line results, which we believe are competitive when compared to other approved and investigational treatments. These results demonstrated a median RPFS of 8.7 months in patients with mCRPC that were heavily pretreated and were not biomarker selected, with PSA reductions of greater than 50% achieved in 36% of these patients. 20% of evaluable patients achieved an ORR with a meaningful duration of response of 7.5 months.

先從第一期單藥試驗開始，投影片 7 彙整了令人鼓舞的主要結果；我們認為與其他已核准及研發中的治療相比具競爭力。結果顯示，在接受多線治療且未依生物標記篩選的 mCRPC 病人中，中位 RPFS 為 8.7 個月；其中 36% 病人的 PSA 降幅超過 50%。在可評估病人中，有 20% 達到 ORR，且反應持續時間（duration of response）具意義，為 7.5 個月。

It is important to note that all of these ORRs were demonstrated at the 2.7 milligram per kilogram adjusted body weight dose utilized in the expansion phase of the trial, providing early evidence of a dose-response relationship.

需要強調的是，所有這些 ORR 皆出現在試驗擴增期所使用的 2.7 毫克/公斤（以調整後體重計）劑量，提供了劑量反應關係的早期證據。

In the top-line results from the Phase 1b/2 investigator-initiated study at UCSF shown on slide 8, combination of FG-3246 with enzalutamide demonstrated encouraging anti-tumor activity with seven months of median radiographic progression-free survival biomarker on selected patients across the entire cohort of 44 patients. Importantly, in patients who had progressed on only one prior ARPI, the combination of FG-3246 and enzalutamide achieved a very meaningful median RPFS of 10.1 months and demonstrated a PSA50 response of 40%.

在投影片 8 所示、由 UCSF 主導的第一期 b/第二期研究者發起試驗（IST）主要結果中，FG-3246 與 enzalutamide 的合併治療在全體 44 名、經生物標記篩選的病人中，展現令人鼓舞的抗腫瘤活性，中位影像學無惡化存活期為 7 個月。重要的是，在僅接受過一種先前 ARPI 且已進展的病人中，FG-3246 與 enzalutamide 的合併治療達到非常具意義的中位 RPFS 10.1 個月，並顯示 PSA50 反應率為 40%。

An important insight gained from the IST is that there was a significant decrease in Grade 3 or greater neutropenia compared to the Phase 1 monotherapy trial due to the use of GCSF prophylaxis. This finding is informative for the inclusion of GCSF prophylaxis in the design of our ongoing Phase 2 monotherapy study as we aim to substantially reduce the number of patients who require dose interruption or downward titration relative to the Phase 1 trial, with the goal of building upon the 8.7 months of RPFS demonstrated in the initial trial.

從該 IST 獲得的一項重要洞見是：相較於第一期單藥試驗，由於使用 GCSF 預防性治療，3 級或以上嗜中性白血球低下的發生率顯著下降。此發現對我們正在進行的第二期單藥研究設計具有參考價值，我們計畫納入 GCSF 預防性治療，以大幅降低相較於第一期試驗需要中斷給藥或下調劑量的病人數，並以在初始試驗中所展現的 8.7 個月 RPFS 為基礎再進一步提升。

Moving to slide 9, the IST also provided us with important insights into the potential for FG-3180 as a PET imaging biomarker for patient selection. On the right-hand part of the slide is an example of a PET image from the IST captured after administration of FG-3180, highlighting significant CD46 tumor expression.

接著看投影片 9，該 IST 也為我們提供了關於 FG-3180 作為病人篩選之 PET 影像生物標記的潛力的重要洞見。投影片右側為 IST 中在施用 FG-3180 後所取得的 PET 影像範例，突顯顯著的 CD46 腫瘤表現。

The table on the left shows that higher tumor uptake of FG-3180 was associated with PSA50 response. Patients with a higher average maximum standardized uptake value, or SUV, of a target lesion, when normalized to the SUV of the blood pool, demonstrated a trend to greater PSA50 response to FG-3246 versus those with a lower SUV, with a nominal p-value that just missed being statistically significant.

左側的表格顯示，FG-3180 在腫瘤中的較高攝取量與 PSA50 反應相關。當以血池的 SUV 進行標準化後，目標病灶的平均最大標準化攝取值（SUV）較高的患者，相較於 SUV 較低者，對 FG-3246 的 PSA50 反應呈現較佳趨勢；其名目 p 值僅略低於達到統計顯著性的門檻。

Of note, this data demonstrates for the first time an association between CD46 expression and response to FG-3246. Further characterization and evaluation of FG-3180 is an important part of the ongoing Phase 2 monotherapy trial.

值得注意的是，這些數據首次顯示 CD46 表達與對 FG-3246 的反應之間存在關聯。對 FG-3180 的進一步特性描述與評估，是正在進行的第 2 期單藥試驗的重要組成部分。

Altogether, the IST further validated important design elements of the ongoing Phase 2 trial, which we believe has the potential to improve upon the median RPFS observed in the Phase 1 monotherapy trial.

總體而言，IST 進一步驗證了正在進行的第 2 期試驗之重要設計要素；我們相信該試驗有潛力改善第 1 期單藥試驗中觀察到的中位 RPFS。

Moving to slide 10, I'll now review the Phase 2 monotherapy dose optimization trial design. This trial aims to enroll 75 patients in the post-one ARPI pre-chemo setting across three dose levels to determine the optimal Phase 3 dose based on efficacy, safety, and PK parameters. As I previously mentioned, FG-3180 will be an integral part of the study as we seek to further explore what was demonstrated in the Phase 1b/2 combination trial, namely to determine whether there is a correlation between CD46 expression and response to the ADC in this all-comers trial.

接著看第 10 張投影片，我將回顧第 2 期單藥劑量最佳化試驗的設計。本試驗旨在於「接受過一種 ARPI 後、化療前」的治療情境中，於三個劑量水準招募 75 名患者，並根據療效、安全性與藥物動力學（PK）參數決定最佳的第 3 期劑量。如我先前所述，FG-3180 將是本研究不可或缺的一部分，因為我們希望在這項不限制入組條件（all-comers）的試驗中，進一步探索第 1b/2 期聯合試驗所顯示的結果，也就是判定 CD46 表達與對該 ADC 反應之間是否存在相關性。

An interim analysis of the open-label trial is planned for the fourth quarter of this year and will include PSA50, ORR, safety, PK, and exposure response data. Importantly, we expect mature RPFS data to become available in 2027 as patients continue their treatment with FG-3246 and the trial progresses towards completion.

這項開放標籤試驗計畫於今年第四季進行期中分析，內容將包括 PSA50、ORR、安全性、PK，以及暴露量-反應（exposure response）數據。重要的是，隨著患者持續接受 FG-3246 治療且試驗推進至完成，我們預期成熟的 RPFS 數據將於 2027 年取得。

On slide 11, I'd like to reiterate the three important steps we have taken with the design of the ongoing Phase 2 monotherapy trial which were further validated with the recently disclosed IST results, as we aim to improve upon the 8.7 months of meeting RPFS demonstrated in the Phase 1 monotherapy trial.

在第 11 張投影片，我想再次強調我們在正在進行的第 2 期單藥試驗設計中採取的三個重要步驟；這些步驟也在近期揭露的 IST 結果中獲得進一步驗證，目標是改善第 1 期單藥試驗所顯示的 8.7 個月中位 RPFS。

First, leveraging earlier evidence of an exposure-response relationship, the Phase 2 study is testing three of the highest doses from the Phase 1 monotherapy study.

第一，基於先前顯示的暴露量-反應關係證據，第 2 期研究正在測試第 1 期單藥研究中三個最高劑量。

Second, primary prophylaxis with GCSF is being utilized to mitigate neutropenia, an approach which was successfully demonstrated in the Phase 2 portion of the recently disclosed IST. The mitigation of neutropenia could enable more consistent exposure to the ADC with fewer dose interruptions or adjustments early in the course of treatment, which could extend the duration of therapy and potentially enhance the efficacy of the ADC.

第二，採用 GCSF 的初級預防（primary prophylaxis）以降低嗜中性球低下的風險；此作法已在近期揭露的 IST 第 2 期部分成功證實。降低嗜中性球低下可使患者在治療早期以較少的劑量中斷或調整，獲得更一致的 ADC 暴露，從而延長治療持續時間，並可能提升 ADC 的療效。

Third, we are enrolling patients in earlier lines of therapy versus the median five prior lines of therapy in the Phase 1 trial. The 10.1 months that median RPFS demonstrated in the IST in patients who progressed on only one prior ARPI underscores the potential of FG-3246 in this patient population.

第三，相較於第 1 期試驗中患者先前治療線數的中位數為 5 線，我們正在更早的治療線別納入患者。IST 中僅在一種既往 ARPI 治療後仍進展的患者，其所顯示的 10.1 個月中位 RPFS，凸顯了 FG-3246 在此患者族群中的潛力。

Together with the insights from the IST, we believe that the design elements have the potential to improve upon the Phase 1 results and achieve a median RPFS of 10 months or greater, which we believe is the benchmark for commercial competitiveness.

結合 IST 的洞見，我們相信這些設計要素有潛力優於第 1 期結果，並達成 10 個月或更長的中位 RPFS；我們認為這是具備商業競爭力的基準。

Slide 12 highlights the momentum we are experiencing with the ongoing Phase 2 trial. We now have 21 sites activated in top-tier institutions across the US and continue to actively screen and enroll patients. The sites are highly engaged, and we are encouraged about our progress to date. While we aren't disclosing enrollment figures at this time, we are on track for the interim analysis in Q4 of this year.

第 12 張投影片突顯我們在正在進行的第 2 期試驗中所展現的動能。我們目前已在全美頂尖機構啟動 21 個研究中心，並持續積極篩選與招募患者。各中心參與度很高，我們對目前的進展感到鼓舞。雖然我們此時不披露入組人數，但我們正按計畫於今年第四季進行期中分析。

To summarize our prostate cancer program, we have an ongoing Phase 2 monotherapy trial in the post-one ARPI pre-chemo setting in mCRPC with important design elements that we believe could enable the ADC to build upon the 8.7 months of median RPFS demonstrated in the Phase 1 trial. We look forward to the interim analysis in the fourth quarter of this year.

總結我們的前列腺癌計畫：我們在 mCRPC 的「接受過一種 ARPI 後、化療前」治療情境中，正在進行第 2 期單藥試驗；其關鍵設計要素我們相信可使該 ADC 在第 1 期試驗所顯示的 8.7 個月中位 RPFS 基礎上再進一步提升。我們期待今年第四季的期中分析結果。

Shifting gears to our roxadustat program. Slide 14 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.

接著轉到我們的 roxadustat 計畫。第 14 張投影片突顯在美國約 49,000 名與低風險 MDS 相關貧血患者中，尚未被滿足的醫療需求，以及 roxadustat 的潛在機會。

Current treatments, as measured by transfusion independence, 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 across multiple lines of therapy.

以輸血獨立性（transfusion independence）衡量，現有治療在不到 50% 的患者中有效。由於目前市場上或後期開發中尚無口服選項，因此存在顯著機會，為不同治療線別的患者提供一種可能具持久效果且口服給藥便利的新療法。

Moving to slide 15, I would like to 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. 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 at least 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 improved therapies for anemia associated with lower-risk MDS.

接著看第 15 張投影片，我想重點說明一項事後分析（post-hoc analysis）的數據：該分析針對在 roxadustat 第 3 期 MATTERHORN 研究中入組、且具有高輸血負擔的低風險 MDS 貧血患者亞組。在此分析中，採用國際工作組對高輸血負擔的定義——在連續兩個 8 週期間內輸注 4 單位或以上紅血球（RBC）——roxadustat 顯示出具意義的治療效果：36% 的患者達到至少 8 週的輸血獨立性，而安慰劑組僅 7%，名目 p 值為 0.041。這些結果與最近兩項獲核准、用於低風險 MDS 相關貧血之關鍵性試驗結果高度相似。

Moving to slide 16, based on these results, our target indication is for the treatment of anemia in patients with lower-risk MDS who are refractory to or ineligible for prior ESA treatment. We believe roxadustat has real potential to elevate the standard of care across multiple treatment lines.

接著看第 16 張投影片，基於這些結果，我們的目標適應症為：治療對既往 ESA 治療無反應（refractory）或不符合既往 ESA 治療資格的低風險 MDS 患者之貧血。我們相信 roxadustat 具有在多條治療線別提升照護標準的實質潛力。

In addition, we believe there is a unique opportunity to demonstrate transfusion independence across both RS-positive and RS-negative patients. Based on a recently conducted opportunity assessment that was informed by primary research with practicing clinicians, we believe roxadustat has the potential to penetrate both RS-positive and RS-negative segments. We further believe that the opportunity in the RS-negative population is substantial given that luspatercept, the market-leading brand and the treatment of lower-risk MDS, has not demonstrated clinically differentiated efficacy in the segment of the lower-risk MDS population.

此外，我們相信有一個獨特機會可在 RS 陽性與 RS 陰性患者中皆證明輸血獨立性。根據近期完成的機會評估（由對臨床醫師的主要研究所提供資訊），我們認為 roxadustat 有潛力同時滲透 RS 陽性與 RS 陰性兩個族群。我們也進一步認為 RS 陰性族群的機會相當可觀，因為市場領導品牌、用於低風險 MDS 治療的 luspatercept，尚未在該低風險 MDS 族群分段中展現具臨床差異化的療效。

Moving to slide 17, in April 2026, we received clinical and statistical information requests from the FDA, which were highly constructive to the Phase 3 design. We've responded to the agency and are in the last stages of finalizing the Phase 3 protocol.

接著看第 17 張投影片，2026 年 4 月，我們收到 FDA 提出的臨床與統計資訊要求（information requests），這些要求對第 3 期設計非常具有建設性。我們已回覆主管機關，目前正處於完成第 3 期試驗方案（protocol）定稿的最後階段。

Of note, the final protocol will specify a primary endpoint of eight-week transfusion independence with key secondary endpoints of 12- and 16-week transfusion independence. We continue to anticipate the initiation of the study in the second-half of 2026, while in parallel continuing to explore the opportunity to develop roxadustat internally or with a strategic partner.

值得注意的是，最終方案將指定「8 週輸血獨立性」為主要終點，並以「12 週與 16 週輸血獨立性」作為關鍵次要終點。我們仍預期於 2026 年下半年啟動研究；同時也將並行探索由內部自行開發 roxadustat 或與策略夥伴合作開發的機會。

To summarize on slide 18, given the sizable unmet need in lower-risk MDS, the dearth of oral treatments available or in late-stage development, the potential to demonstrate efficacy in RS-negative patients, and the recently granted orphan drug designation, roxadustat represents a compelling commercial opportunity for Kyntra Bio.

在第 18 張投影片總結：鑑於低風險 MDS 的龐大未滿足需求、可用或處於後期開發的口服治療稀缺、在 RS 陰性患者中證明療效的潛力，以及近期獲授予的孤兒藥資格認定（orphan drug designation），roxadustat 對 Kyntra Bio 而言代表一項具吸引力的商業機會。

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

接下來，我將把電話會議交給 Dave，請他說明公司的財務狀況。Dave？

Thank you, Thane. For the first quarter of 2026, total revenue was $3.7 million compared to $2.7 million for the same period in 2025. Total operating costs and expenses for the first quarter of 2026 were $17.6 million compared to $17.7 million for the first quarter of 2025.

謝謝你，Thane。2026 年第一季總營收為 370 萬美元，較 2025 年同期的 270 萬美元增加。2026 年第一季的總營運成本與費用為 1,760 萬美元，與 2025 年第一季的 1,770 萬美元相當。

R&D expenses for the first quarter of 2026 were $7.6 million compared to $9.2 million in the first quarter of 2025.

2026 年第一季研發（R&D）費用為 760 萬美元，較 2025 年第一季的 920 萬美元下降。

SG&A expenses for the first quarter of 2026 were $5.9 million compared to $8.1 million in the first quarter of 2025.

2026 年第一季銷售、一般及行政（SG&A）費用為 590 萬美元，較 2025 年第一季的 810 萬美元下降。

During the first quarter of 2026, we recorded a net loss from continuing operations of $15.1 million or $3.74 net loss per basic and diluted share compared to a net loss of $16.8 million or $4.15 net loss per basic and diluted share one year ago.

2026 年第一季，我們持續營運的淨損為 1,510 萬美元，或每股基本及稀釋後淨損 3.74 美元；相較之下，一年前的淨損為 1,680 萬美元，或每股基本及稀釋後淨損 4.15 美元。

Now shifting toward cash, as of March 31, we reported $100.3 million in cash equivalents, investments, and accounts receivable. We expect the company to have cash runway into 2028, enabling us to continue to invest in our US pipeline opportunities.

接著談現金狀況，截至 3 月 31 日，我們申報的現金等價物、投資與應收帳款合計為 1.003 億美元。我們預期公司現金可支應至 2028 年，使我們得以持續投資於美國的產品線機會。

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

謝謝，接下來我把電話會議交回給 Thane。

Thank you, Dave. In closing, we are continuing to make important progress across our pipeline and are well-positioned to support multiple clinical milestones from now into 2028. We will continue our disciplined execution of the FG-3246 and FG-3180 program with expected interim analysis from the Phase 2 monotherapy trial in the fourth quarter of 2026 and anticipate initiation of the Phase 3 trial for roxadustat in lower-risk MDS in the second-half of 2026.

謝謝你，Dave。最後，我們在整體研發管線上持續取得重要進展，並已做好充分準備，從現在到 2028 年支持多項臨床里程碑。我們將持續以嚴謹紀律推進 FG-3246 與 FG-3180 計畫，預期於 2026 年第四季取得第 2 期單藥試驗的期中分析結果，並預計於 2026 年下半年啟動 roxadustat 用於低風險 MDS 的第 3 期試驗。

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

接下來，我想把電話交給接線員進行問答。

(Operator Instructions) Alex Ramsey, William Blair.

（接線員指示）Alex Ramsey，William Blair。

Hello, this is Alex on for Andy Hsieh. Thank you for taking our question. So just thinking about the fourth-quarter update, what do you want to see for 3180 in Phase 2 to use it in Phase 3? So you just want to see that p-value be specifically significant or are there other metrics you plan to look at to make that decision?

大家好，我是 Alex，代替 Andy Hsieh 發言。感謝讓我們提問。就第四季的更新來看，對於 3180 在第 2 期你們希望看到什麼，才會用於第 3 期？你們是希望 p 值達到特定的統計顯著性，還是還有其他指標會用來做這個決策？

And then related, what role could 3180 serve in the Phase 3 even if you decide to not enroll patients based on uptake of 3180? So could you still use it as a way to kind of look at CD46 expression or which is not incorporated at all into the different?

另外相關的問題是，即使你們決定不根據 3180 的採用情況來納入病人，3180 在第 3 期中仍可能扮演什麼角色？例如是否仍可用來觀察 CD46 表現量，或是這部分完全不會納入不同的（設計）之中？

Yeah. Alex, thanks for the question. This is Thane. I'll answer first and then Carol, if you've got thoughts in addition to mine, please chime in.

好的。Alex，謝謝你的問題。我是 Thane。我先回答，然後 Carol，如果你有補充想法也請加入。

First, as it relates to the parameters that we're going to be looking at with respect to the fourth quarter of this year and the interim analysis, Alex, I think that's what you were asking. Is that correct? Alex?

首先，關於我們在今年第四季與期中分析時將觀察的參數，Alex，我想這就是你在問的，對嗎？Alex？

And so, as we've stated before, the interim analysis, we're going to be looking at some of the typical measures, PSA50, ORR, duration of response, dose response, PK parameters, things of that nature, which will then inform our decision to continue, and if we do continue, do we continue with all three doses or perhaps are we seeing something with a particular dose that would allow us or enable us to perhaps drop that dose and then accrue those patients in the remaining doses.

因此，如同我們先前所述，在期中分析中，我們會看一些典型指標：PSA50、ORR、反應持續時間、劑量反應、PK 參數等，這些將用來支持我們是否繼續的決策；若繼續，則會決定是否三個劑量都繼續，或是否在某個特定劑量看到訊號，使我們能夠或有條件地淘汰該劑量，並將病人累積到其餘劑量組。

What we've also said before is that we've got a hurdle that is consistent with this composite response of ORR and PSA50 that we saw in the Phase 1 monotherapy trial. And the reason that is the case is because we are most interested in getting to the more fully mature RPFS data in 2027. And so clearly, if we see either safety or efficacy results that are not meeting our expectations, and we'll be able to (inaudible) however, we do expect, given the further that we've set, we do expect the assets to continue on until we see the more fully mature RPFS data in 2027.

我們也曾提到，我們設定的門檻與第 1 期單藥試驗中看到的 ORR 與 PSA50 的複合反應一致。之所以如此，是因為我們最關注的是在 2027 年取得更成熟的 RPFS 數據。因此，若我們看到安全性或療效結果未達預期，我們將能夠（聽不清）不過，基於我們設定的門檻，我們預期該資產會持續推進，直到我們在 2027 年看到更成熟的 RPFS 數據。

Carol, anything to add there before we hit the question on 3180?

Carol，在我們進入 3180 的問題之前，你還有什麼要補充的嗎？

Nothing to add. Thank you.

沒有補充。謝謝。

Okay. And then as it relates to FG-3180 and in the Phase 3 portion of the program, clearly, if we see a correlation between expression of CD46 and response to the ADC across the 75 patients in the phase two trial, and we'll also be able to then compile that data across 75 patients with the 25 patients worth of data we have from Dr. Aggarwal (inaudible). And so that'll be pretty informative of the potential correlation between the expression of the target response to the ADC. And then that would allow us, we think, to be able to then better select and target patients who are higher expressors of CD46 for the Phase 3 portion of the program.

好的。接著談到 FG-3180 在該計畫第 3 期部分的角色：如果我們在第 2 期試驗的 75 位病人中看到 CD46 表現量與 ADC 反應之間的相關性，我們也能把這些資料與我們從 Aggarwal 醫師那裡取得的 25 位病人資料（聽不清）合併彙整。這將非常有助於判斷標的表現量與 ADC 反應之間可能的相關性。接著我們認為，這將使我們能在計畫第 3 期部分更好地篩選並鎖定 CD46 高表現的病人。

If we don't see a correlation, then we do think it would still be instructive to collect the expression data. And clearly, when you're moving from a Phase 2 trial of 75 patients to a Phase 3 trial of 400 patients or more, the more data that we have, obviously, the more informed we're going to be with respect to characterization of the target.

如果我們沒有看到相關性，我們仍認為收集表現量資料具有指導意義。顯然，當你從 75 人的第 2 期試驗走向 400 人或更多的第 3 期試驗時，我們掌握的資料越多，就越能更有依據地進行標的特性描述。

But if we see a strong RPFS signal in the Phase 2 trial in an all-comer sort of population, in other words, if we don't see a correlation, then we do think it would be instructive to capture CD46 data with the CD46 PET imaging agent, but it will be in an all-comer's population in the Phase 3 part of the program.

但如果我們在第 2 期試驗、以不分族群（all-comer）的受試者中看到強烈的 RPFS 訊號，也就是說如果我們沒有看到相關性，那麼我們仍認為用 CD46 PET 影像試劑來取得 CD46 資料會很有幫助；不過在計畫第 3 期部分，將會是在 all-comer 族群中進行。

Carol, thoughts on that one?

Carol，對這點你有什麼看法？

Yeah. Just to reiterate, if supported by Phase 2 data, we would consider using FG-3180 as a patient selection biomarker for the Phase 3 pivotal trial so that we would conduct this trial in CD46 high population if supported by Phase 2 data.

有的。再強調一次，如果第 2 期數據支持，我們會考慮在第 3 期關鍵性試驗中使用 FG-3180 作為病人篩選的生物標記，亦即在第 2 期數據支持的前提下，我們會在 CD46 高表現族群中進行該試驗。

That's super helpful. And so just to clarify, and sorry, I was on you earlier, but just to clarify, basically in Phase 2, you really just want that p-value to be statistically significant to kind of confirm that correlation?

這非常有幫助。那我再確認一下，也抱歉我剛剛打斷你，但我想確認的是：基本上在第 2 期，你們主要就是希望 p 值達到統計顯著，來確認這個相關性，對嗎？

Yeah, that's exactly right. And we've got the SAP that's in place right now. And given the open label nature of the trial, which is a really positive part of this Phase 2 design, is that we're going to be informed of these CD46 expression patterns early in the course of this trial. And we'll be able to then start to look at correlation early with PSA50, then over time with RPFS. But yeah, we'll be looking at -- to see if there is a correlation, we'll be looking to ensure that the statistics support that.

對，完全正確。我們目前已有 SAP（統計分析計畫）。而且由於這個試驗是開放標籤，這其實是第 2 期設計中非常正面的部分，因為我們能在試驗早期就得知這些 CD46 表現型態，並能及早開始用 PSA50 來觀察相關性，之後隨時間再用 RPFS 來觀察。不過是的，為了判斷是否存在相關性，我們會看統計結果是否支持。

Okay, perfect. Thanks so much. Appreciate it.

好的，完美。非常感謝，感激不盡。

Matthew Keller, H.C. Wainwright.

Matthew Keller，H.C. Wainwright。

Hey, everyone. Thanks for the update, and thanks for taking our questions. So kind of related to the previous questions, but I was wondering, since you presented the IST data, if you've received any additional feedback or any change in the amount of inbounds you've had, particularly related to 3180?

各位好。謝謝更新，也謝謝回答我們的問題。這跟前面問題有點相關，但我想問的是，自從你們發表 IST 數據後，是否收到任何額外回饋，或是你們收到的主動洽詢（inbounds）數量有沒有變化，特別是與 3180 相關的？

And then my second question, just briefly, is, do you know when we can expect maybe more details related to the roxa Phase 3 trial?

第二個問題簡短問一下：我們大概何時可以期待看到更多與 roxa 第 3 期試驗相關的細節？

Yeah. Thanks, Matt, for the questions. In terms of additional inbounds on 3180, I won't comment on any business development activities, which are ongoing at this point in time. Clearly, we do believe that that particular data point from the IST is one of the most intriguing and thought-provoking data points from the IST. The mitigation of neutropenia with GCSF, an important finding that we've now incorporated into the Phase 2 design.

謝謝，Matt，謝謝你的問題。關於 3180 額外的主動洽詢，我不會評論任何商務開發活動，因為目前仍在進行中。顯然，我們確實認為 IST 的那個特定數據點，是 IST 中最引人入勝、也最發人深省的數據點之一。以 GCSF 緩解嗜中性球低下是一項重要發現，我們現在已將其納入第 2 期設計。

And then the data that we've seen with respect to that association between CD46 expression and response to the ADC not only is intriguing for us, but it's intriguing for others as well, so I'll leave it at that.

另外，我們看到 CD46 表現量與 ADC 反應之間的關聯性相關數據，不僅對我們很有吸引力，對其他人也同樣有吸引力，所以我就先說到這裡。

Carol, any additional thoughts on that one?

Carol，對這題你還有補充想法嗎？

Just to build on that, we have had very encouraging interactions with investigators in the community at ASCO GU. And we're also seeing the excitement reflected in the current enrollment activities at our 21 active sites, so that speaks a lot to that as well. Thank you.

我補充一下：在 ASCO GU 期間，我們與社群中的研究者有非常令人鼓舞的互動。我們也看到這份興奮反映在目前 21 個啟動中試驗中心的收案活動上，這也很能說明問題。謝謝。

And then in terms of roxa Phase 3 and sharing additional information, we'll continue to keep you -- the investment community updated. We probably won't be commenting any further with respect to our Phase 3 protocol, the information, and the feedback that we got through the information requests from the FDA, as I said, were very instructive, both on the statistical as well as on the clinical side. So we are very close to finalizing the protocol.

至於 roxa 第 3 期以及分享更多資訊，我們會持續向投資社群更新。我們可能不會就第 3 期方案本身、相關資訊，以及我們透過 FDA 資訊請求所獲得的回饋再做進一步評論；如我所說，那些回饋在統計面與臨床面都非常具有指導性。因此，我們已非常接近完成方案定稿。

We've selected the CRO for the trial, and we continue to have conversations about how we ultimately conduct the trial, whether it's on our own or whether it's with a strategic. And so we'll just keep, Matt, you and others posted as we continue to make progress.

我們已為該試驗選定 CRO，並持續討論最終如何執行試驗，是由我們自行進行，或與策略夥伴合作。因此，Matt，我們會在持續取得進展的同時，隨時向你以及其他人更新。

Yes, perfect. Thank you so much.

好的，太好了。非常感謝。

(Operator Instructions) And I'm not showing any further questions in the queue. I'd like to turn it back over to Thane for any closing remarks.

（接線員指示）目前我這邊顯示隊列中沒有其他問題了。我想把電話交回給 Thane，請他做結語。

Yeah. Thanks for joining us today for the first-quarter earnings call and for your interest in Kyntra Bio. Enjoy the rest of your day. Thanks, everyone.

好的。感謝各位今天參加第一季財報電話會議，也謝謝各位對 Kyntra Bio 的關注。祝各位今天剩下的時間愉快。謝謝大家。

Thank you for your participation in today's conference. This does conclude the program. You may now disconnect. Everyone, have a great day.

感謝各位參與今天的會議。本次議程到此結束。您現在可以掛線。祝各位有美好的一天。