KYNB 2026 年第二季法說會：9,570 萬美元流動資金與第四季臨床催化劑

重點摘要

• KYNB 截至 2026 年 6 月 30 日擁有 9,570 萬美元的現金、現金等價物、投資及應收帳款。管理層預期其現金消耗年限可延續至 2028 年。
• FG-3246 用於轉移性去勢抗性前列腺癌的第 2 期單藥治療試驗按計畫推進，預計將於 2026 年第 4 季對 36 名患者進行中期分析。該試驗預計在三個劑量層級招募 75 名患者。
• 管理層設定 FG-3246 的中位影像學無進展生存期目標至少為 10 個月，而先前第 1 期單藥治療試驗則為 8.7 個月。
• 該公司已敲定 roxadustat 用於低風險骨髓增生異常症候群第 3 期試驗的計畫書，並目標於 2026 年第 4 季啟動該研究，可能由內部籌集額外資金自行開展，或透過策略夥伴關係進行。
• 2026 年第 2 季營運成本與費用從去年同期的 1,340 萬美元增加至 1,610 萬美元。該公司錄得持續營運淨利潤 1,200 萬美元，而 2025 年第 2 季則為淨虧損 1,370 萬美元。

主要財務數據

業務與營運表現

用於轉移性前列腺癌的 FG-3246 與 FG-3180

FG-3246 是一款具首創 (first-in-class) 潛力、針對 CD46 的抗體藥物複合體 (ADC)，而 FG-3180 則是其搭配使用、採用相同 YS5 標靶抗體的正電子斷層掃描 (PET) 影像劑。該公司正開發此計畫，作為轉移性去勢抗性前列腺癌 (mCRPC) 的非 PSMA 療法。

目前進行中的開放標籤第 2 期試驗預計在患者先前接受過一次雄性激素受體通路抑制劑 (ARPI) 治療且尚未進行化療的情況下招募 75 名患者。該試驗正評估 1.8、2.4 及 2.7 mg/kg 劑量的 FG-3246。所有患者均接受 FG-3180 影像檢查，以評估 CD46 表達與治療反應之間的關係。

2026 年第 4 季的中期分析將涵蓋 PSA50 反應、客觀反應率、安全性、藥物動力學及暴露-反應數據。無效性 (futility) 將結合 PSA50 與客觀反應進行評估。成熟的影像學無進展生存期數據預計將於 2027 年期間得出。

管理層強調了先前的臨床結果，顯示在第 1 期單藥治療試驗中，中位影像學無進展生存期為 8.7 個月，PSA50 反應率為 36%。在 FG-3246 聯合恩雜魯胺 (enzalutamide) 的研究者發起試驗中，先前僅接受過一次 ARPI 治療的患者實現了 10.1 個月的中位影像學無進展生存期，PSA50 反應率為 40%。

第 2 期試驗設計納入了預防性使用 G-CSF，以減少嚴重嗜中性白血球減少症、減少劑量中斷，並支持更一致的藥物暴露。該公司在美國頂尖機構設有 23 個活躍的試驗中心。

Roxadustat 用於低風險 MDS

KYNB 敲定了 roxadustat 第 3 期試驗計畫書，旨在治療先前對紅血球生成刺激劑治療無效或不適用的低風險骨髓增生異常症候群患者的貧血。

在第 3 期 MATTERHORN 研究中高輸血負擔患者的事後分析 (post hoc analysis) 中，接受 roxadustat 治療的患者中有 36% 實現了至少連續 8 週無須輸血，而安慰劑組則為 7%。名義 p 值為 0.041。

新的第 3 期試驗將以前 24 週內連續 8 週無須輸血作為主要終點。關鍵次要終點將評估在 48 週期間內 12 週、16 週及 24 週無須輸血的情況。該研究將招募足夠的 RS 陽性與 RS 陰性患者，以評估這兩組患者的療效。

管理層展望

管理層預期其 9,570 萬美元的流動資金足以支持營運至 2028 年，同時支持該公司在美國的產品管道發展。

近期主要的催化劑為 2026 年第 4 季 FG-3246 的第 2 期中期分析，以及預計於 2026 年第 4 季啟動的 roxadustat 第 3 期試驗。若由內部自行啟動 roxadustat 研究將需要額外資金；該公司同時正在評估策略合作夥伴關係的選項。

風險與關注焦點

• Roxadustat 第 3 期試驗的啟動取決於能否為內部開發籌集資金，或達成可接受的策略合作安排。
• 根據該公司與阿斯特捷利康 (AstraZeneca) 的協議，若自行開發與商業化，需支付淨銷售額中個位數百分比的權利金。若該計畫採取合作開發，阿斯特捷利康將獲得 KYNB 所獲經濟收益的 35%。
• 支持性的 MATTERHORN 結果來自高輸血負擔亞組的事後分析，且僅具名義 p 值。
• 嗜中性白血球減少症一直是 FG-3246 的重要安全性考量。目前的試驗採用預防性 G-CSF 來減輕 3 級或以上的事件。
• 由於 mCRPC 疾病通常集中於骨骼，限制了配對切片取樣的可行性，因此組織收集受到限制。該公司亦同時使用影像學及循環腫瘤 DNA (ctDNA) 評估。

分析師問答亮點

在計劃中的第 3 期試驗中，roxadustat 的劑量調整可能每 6 週進行一次。管理層表示，劑量滴定將基於效益與風險評估，包括血紅素水平和血紅素增加速率。在 2.5 mg/kg 至 3.5 mg/kg 之間將使用中間劑量階梯。

關於 FG-3246，管理層表示第 2 期隨機分配的患者中約有 30% 先前曾接受過 Pluvicto 治療。統計分析計畫包含根據先前 Pluvicto 暴露史進行的預先指定評估，儘管管理層尚未承諾針對該亞組採取加速批准策略。

管理層表示，FG-3246 相對於 PSMA 標靶疗法的最終定位將由數據驅動。在 FG-3180 影像、PSMA 掃描、組織收集及 ctDNA 分析的支援下，該公司正在評估 CD46 標靶治療是否能在 PSMA 治療後為患者提供服務，或用於其他患者亞組。

法說會完整逐字稿

完整財報電話會議逐字稿

管理層陳述

Operator

Thank you. Good day and thank you for standing by. Welcome to the Kentra BIO Second Quarter 2026 Earnings Conference Call. At this time, all participants are in a listen-only mode. Later, we will conduct a question and answer session. If you would like to ask a question at that time, please press star 1-1 on your telephone and wait for your name to be announced. Please be advised that today's conference is being recorded. I would now like to hand the conference over to your speaker today, Gaia Shamus of LifeSci Advisors.

Please go ahead.

Daia Vasiliver-Shamis

Thank you, Latonya, and good afternoon everyone. Thank you for joining today to discuss KintraBio's second quarter 2026 financial and business results. I'm Gaia Chamis from Lifeline Advisors. Joining me on today's call are Thayne Wettig, Chief Executive Officer, David DiLuccier, Chief and Carl Gadum, Vice President of Product Development. Following the prepared remarks, we will open the call to your questions. I would like to remind you that remarks made on today's call include forward-looking statements about Kindred's bio. Such statements may include, but are not limited to, collaborations with AstraZeneca and Astellas, financial guidance, the initiation in the bio, and the application of the bio to the 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.

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. Our complete description of these and other material risks can be found in KintraBio's filing with the SEC, including our most recent Form 10-K and Form 10-Q. Intrabio does not undertake any obligation to update publicly any forward-looking statements, whether as a result of new information, future events, or otherwise. 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 investor section of Kintra Bio website at www.kintrabio.com. With that, I would like to turn the call over to the CEO, Thane Wedding. Thane?.

Unknown Speaker

Thank you, Gaia. Good afternoon, everyone, and welcome to our second quarter 2026 earnings call. On today's call, I will provide an update on the important progress we have made across our clinical portfolio. First, with FG3246, our potential first-in-class antibody drug conjugate targeting CD46 and its companion Canyon 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 De La Chia, our CFO, will review the financials, after which we will open the call for your questions. Starting with slide three, I'd like to highlight our mid- and late-stage programs and upcoming catalysts. phase 2 monotherapy trial for FG3246 and its companion diagnostic FG3180 in the post-ARPI pre-chemo setting in metastatic castration-resistant prostate cancer continues to actively enroll patients, and we are on track for the results from the interim analysis in the fourth quarter of this year. With our Roxy-Dustat program, the protocol for the Phase III trial has been finalized, and we are advancing towards our goal of initiating the registrational trial in the fourth quarter of 2026. the simplified capital structure and cash runway into 2028. We remain committed to executing on our strategic vision and look forward to the upcoming catalysts for both clinical programs.

Let's start with the FG3246 and FG3180 program in MCRPC. Then that need for new treatments for the 65,000 men in the U.S. diagnosed every year with drug-treatable castration-resistant metastatic disease is substantial. Targeting CD46, a novel tumor-selective, multifunctional epitope that helps tumors evade complement-dependent cytotoxicity could help address this need. Moving to slide five, what sets CD46 apart from non-PSMA tumor antigen targets for metastatic prostate cancer centers on four key points. First, it is highly expressed in prostate cancer and other tumors, yet with limited expression in normal tissue. Second, CD46 is upregulated during tumorigenesis, as well as during the progression from localized castration-sensitive prostate cancer to metastatic castration-resistant prostate cancer. Third, an estimate of 15 to 70% of patients have high CD46 expressing tumors.

And finally, relative to PSMA, CD46 expression is more uniform with lower interpatient variability and with higher median expression in MCRPC tissues, which make it a compound non-PSMA therapeutic target. Slide six highlights FT-3246, our CD46 targeting potential first-in-class ADC, which combines the YS5 antibody with an MMAE payload. UMAE is the payload for five currently marketed ADCs that generated approximately $5 billion in worldwide revenue in 2025, making it a well-characterized therapeutic approach for treating solid tumors. The OIS5 antibody offers an androgen receptor agnostic and non-PSMA approach, differentiating it from many of the prostate cancer treatments currently in development. As with the ADC, our companion imaging agent, FGE3180, utilizes the same YS5 targeting antibody and is being developed under its own IND. We believe that having a patient selection biomarker could enable us to potentially enrich the patient population in a Phase III trial, while also differentiating the patient population. FG3246 in the prostate cancer treatment paradigm.

It also represents an important commercial opportunity as a companion diagnostic to FG3246, similar to the existing PSMA PET agents, which generated revenue of almost $2 billion in 2025. FG3180 is an important part of our ongoing phase two trial, where we will assess the correlation between CDP expression as measured by the PET agent in response to FG3246. Our aim is a clinically differentiated therapeutic in a competitive yet highly unsatisfied MCRPC market. Importantly, we are the only non-PSMA program in mid- to late-stage development that combines a therapeutic with a companion PET imaging agent. The excitement we have in this program comes from the clinical results for FG3246 across two distinct trials. We believe these results, summarized on slide seven, are competitive when compared to other approved and investigational treatments. In the phase one monotherapy trial highlighted on the left part of the slide, FG3246 demonstrated a median RPFS of 8.7 months in patients with MCRPC who were heavily pretreated and were not biomarker selected, with PSA50 response of 36%. 20% of the 25 resistive-available patients achieved an ORR with a meaningful duration of response of 7.5 months.

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 providing early evidence of a dose-response relationship. In the top line results from the Phase 1B2 investigator-initiated study that UCSF summarized on the right side, combination of FG3246 with enzalutamide demonstrated encouraging anti-tumor activity with seven months of median radiographic progression-free survival in biomarker unselected patients across the entire cohort of 44 patients. Importantly, in patients who had progressed on only one prior ARPI, the combination of of FT-3246 and enzalutamide achieved a meaningful median RPFS of 10.1 months with a PSA50 response of 40%. In addition to the efficacy measures, the ISP provided us with important insights into the adverse event profile of the ADC. The use of GCSF prophylaxis led to a significant decrease in grade 3 or greater neutropenia compared to the phase 1 monotherapy trial. This approach is now designed into our ongoing phase 2 monotherapy study where our objective is to keep more patients on their initial dose without the same degree of dose interruption or reduction experienced in the Phase I monotherapy trial, with the aim to build upon the 8.7 months of RPFS demonstrated in the Phase I trial. Moving to slide 8, an additional insight we gained from the IST is that higher tumor uptake of FG3180 was associated with greater PSA50 response.

The PET imaging on the right is from a patient with clear and meaningful expression of CD46 after exposure to FG3180. The bottom row of the table on the left shows that 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 FG3246 versus those with a lower SUV. with a nominal p-value that just missed being statistically significant despite the small number of patients. This is the first observed association between CD46 expression and response to FG3246. We aim to further characterize this association as part of the ongoing phase two monotherapy trial. Slide 9 lays out the design for this Phase II monotherapy trial, where we will enroll 75 patients in the post-1-AORPI pre-chemo setting across three dose levels, with the primary objective to select the optimal Phase III dose based on efficacy, safety, and PK measures. All patients in the study will be treated with FG3180 in order to further explore the correlation between CD46 expression and response to the ADC in this biomarker unselected trial. The interim analysis of this open-label trial is on track for the fourth quarter of this year and will include PSA50 response, ORR, safety, PK, and exposure response data.

Futility will be assessed by a composite response rate of PSA50 and ORR. Importantly, we expect mature RPFS data to become available throughout 2027 as patients continue their treatment with FG3246 and the trial progresses toward completion. On slide 10, we'd like to emphasize the three design elements we have incorporated with the aim of improving upon the 8.7 months of median RPFS demonstrated in the Phase I trial. First, we are testing three of the highest doses from the Phase I monotherapy study, 1.8, 2.4, and 2.7 milligrams per kilogram. Second, primary prophylaxis with GCSF is being utilized to mitigate neutropenia, an approach which was successfully implemented in the Phase II portion of the IST. We believe reducing the incidence of grade 3 or greater neutropenia should lead to fewer dose interruptions or adjustments, extending the duration of therapy, and enabling more consistent exposure to the ADC. of FG3246. And third, we are enrolling patients who are earlier in the progression of MCRPC versus the median five prior lines of therapy in the phase one trial.

The 10.1 months of median RPFS demonstrated in the IST in patients who progress on only one prior ARPI underscores the potential of FG3246 in this patient population. Together we believe these design elements have the potential to improve upon the Phase I results and achieve a median RPFS of 10 months or greater, which can be viewed as a threshold for commercial competitiveness. Slide 10 shows the sites who are participating in the ongoing Phase 2 trial. We now have 23 sites live at top-tier U institutions, and we continue to be encouraged by our progress to date. We remain on track for the interim analysis of 36 patients in the fourth quarter of this year. To conclude this update on FG3246, we are actively enrolling patients in our Phase II monotherapy trial in the post-1ARPI pre-chemo MCRPC setting with important design elements in place that we believe could enable FG3246 to surpass the 8.7 months of median RPF best demonstrated in the Phase 1 trial. We look forward to the interim analysis in the fourth quarter of this year.

Moving on to the Roxodustat Lower Risk Mildness Plastic Syndrome Program on slide 13. There are approximately 50,000 patients with anemia associated with lower risk MDS in the U.S. with current therapies effective in less than 50% of these patients. With no oral options currently on the market or in late stage development, there's a significant opportunity for an effective, durable, convenient oral treatment that works across multiple lines of therapy. Slide 14 highlights why we believe Roxidustab can be that treatment. In a post hoc analysis of high transfusion burden patients from our previous phase III Matterhorn study using the international working group definition for high transfusion burden of four or more RBC units in two consecutive eight-week periods, we saw that 36 percent of patients treated with roxidustat achieved transfusion independence. for at least eight straight 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. Turning to slide 15, based on these results, our target indication is intended to be for the treatment of anemia in patients with lower-risk MDS who are refractory to or ineligible for prior ESA treatment, where we believe Rotsadustat can raise the standard of care across multiple lines of treatment.

We believe we also have a unique opportunity to demonstrate transfusion independence across both RS-positive and RS-negative patients. As presented in our most recent disclosure at EHA, the European Hematology Association, in a post hoc analysis of the Phase III Matterhorn study, Roxadustat demonstrated similar rates of transfusion independence across both RS positive and RS negative patients. Primary research that we have conducted with practicing clinicians indicates that Ruxidustab has the potential to be a useful treatment in both of these patient segments. The RS negative opportunity, which represents a majority of lower risk MDS patients, is especially relevant given that Lusvapracept, the market leading brand in the treatment of lower risk MDS, has not demonstrated clinically differentiated efficacy in this segment of the lower risk MDS population and is not indicated for use in the second line setting in RS-negative patients. We believe that demonstrating similar efficacy across the entire patient population could position Rocto-Ducet favorably in the treatment paradigm of lower risk MDS. Slide 16 provides an overview of the Phase III trial. Following our interactions with the FDA, we have now finalized the protocol for the Phase III study, which includes a primary endpoint of eight-week transfusion independence over the first 24 weeks of the trial, with key secondary endpoints of 12-, 16-, and 24-week transfusion independence over 48 weeks.

We continue to explore the opportunity to develop Roxidustat internally or with a strategic partner, which aligns with our goal of initiating the study in the fourth quarter of 2026. To summarize the Roxyduce-Stat opportunity in lower risk MDS on slide 17, with a substantial unmet need, no oral therapeutic options on the market or in late development, potential in RS negative patients and an orphan drug designation in hand we see Roxadustat as a compelling commercial opportunity. We continue to make important progress with the phase 3 enabling activities. With that, I will now turn the call over to Dave to discuss the company's financials. Dave?.

Unknown Speaker

Thank you, Thayne. For the second quarter of 2026, total revenue was negative $1.5 million compared to $1.3 million for the same period in 2025. Total operating costs and expenses for the second quarter of 2026 were $16.1 million compared to $13.4 million for the second quarter of 2025. R&D expenses for the second quarter of 2026 were $6.8 million compared to $5.9 million in the second quarter of 2025. SG&A expenses for the second quarter of 2026 were $9.3 million compared to $7.1 million in the second quarter of 2025. During the second quarter of 2026, we recorded a net income from continuing operations of $12 million, or $2.96 net income per basic and diluted share, compared to a net loss of $13.7 million, or $3.38 net loss per basic and diluted share. share one year ago. Now shifting towards cash. As of June 30th, we reported $95.7 million in cash, cash equivalents, investments, and accounts receivable. We expect the company to have a cash runway into 2028, enabling us to continue to invest in our U.S. pipeline opportunities.

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

Unknown Speaker

call back over to Fane. Thank you, Dave. We entered the second half of 2026 with promising momentum. We will continue our disciplined execution of the FG3246 and FG3180 program with results from the interim analysis of the phase two monotherapy trial expected in the fourth quarter of 2026 and continue the phase three enabling activities for Roxodustat with the goal of initiating the Phase 3 trial in lower-risk MDS in the fourth quarter of 26. With that, I would now like to turn the call over to the operator for Q&A.

Operator

Certainly. As a reminder, to ask a question, please press star 1-1 on your telephone and wait for your name to be announced. To withdraw your question, please press star 1-1 again. Please stand by while we compile our Q&A roster. Our first question will come from the line of Alex Ramsey of William Blair. Your line is open.

分析師問答

Alexandra Ramsey

Hi, this is Alex on for Andy. So for the upcoming phase three trial of Roxadustat, the dosing regimen begins with 2.5 mg per kg with potential for titrating up to 3.5. So we were just wondering how that determination is made and if it's based on tolerability or efficacy, after starting the treatment the assessment is made and then also what the titration interval is from both a timing and a dosing perspective.

Unknown Speaker

Thanks, Alex, for the call. I'm going to hand that question over to Carol Gattam, our VP of Product Development.

Unknown Speaker

Thank you for the question. So up titration or down titration is based on an assessment of benefit and risk, as you have highlighted. And the assessment is or a change in dose is possible every six weeks based on what we see frequently.

Alexandra Ramsey

from a benefit and risk perspective. Perfect, thank you so much. And so, and that is it straight from the beginning. from 2.5 to 3.5 if they go up in dose or is there some interval in between? There are some intervals in between. There are some intervals in between, yes.

Unknown Speaker

Okay, perfect. Thank you so much. And Alex, there will be very specific guidance to the sites on the titration either up or down based upon a number of factors, including hemoglobin level and the rate of rise of that hemoglobin level as well.

Operator

Perfect. Thank you so much. And our next question will be coming from the line of Matthew Keller of HC Wainwright. Your line is open.

Matthew Keller

Hey, good afternoon everyone. Thanks for taking our questions. So I guess on the ROXA program as well, first I was wondering if you could remind us, you know, how contingent are you starting the phase three on a partner? And then a follow up to that I was wondering is, you know, how has the Matterhorn data change your calculus at all on potentially partnering that program.

Unknown Speaker

Thanks, Matt, for the question. So the start of the phase three, as we've stated previously, we are undergoing both the opportunity to develop internally as well as partner the program. To develop internally, we would have to bring in capital in order to do that. And so that's a consideration while we also evaluate strategic partners as well. And so we're running a parallel path with both of these. And at the end of the day, we're going to make the decision that we believe is in the best interest of shareholders. There are some dynamics in play related to economics. So if you think about the license that we wholly own in North America and South America, that was a license that was previously held by AstraZeneca during the development of the CKD program.

When we negotiated those rights back from AZ, if we were to develop Roxadustat on our own and commercialize on our own. we would owe AZ a mid single digit royalty on net sales. If we were to partner the product, the program with a strategic and somebody else were to develop and commercialize, AZ would then be entitled to 35% of any economics that would accrue to Kentra Bio. So that's one consideration from an economic perspective. strategic and operational considerations that we continue to evaluate. And as I said, we're going to ultimately make the call that we believe is in the best interest of shareholders.

Matthew Keller

Yes, it totally makes sense. And then can you comment at all about how the RS data is maybe playing into that, if at all? And if I may, kind of an adjacent question, did the RS data also influence the potential phase three design at all? Sorry, I'm going to pepper you with a couple there. No, it's a great question. And so yes.

Unknown Speaker

The RS kind of dynamic with respect to RS positive and RS negative, there's clearly a larger need in the marketplace for RS negative patients, given the fact that Lusbatyrecept has not been able to really show any sort of a benefit relative to ESAs in that particular patient population. And in fact, they're not indicated in the second line setting for RS negative patients. And so, the understanding of that dynamic, obviously plays into how we think about the opportunity, how we think about the clinical design, think about we're going to make sure that we enroll a requisite number of both RS positive and RS negative patients in the phase three trial so that we can have the power to be able to demonstrate that roxidustat works across both of those patient populations but the RS negative opportunity or the the Matterhorn data, we'd be pursuing this regardless of the opportunity for Roxy-Dustat to perhaps show a differential benefit in RS-negative patients relative to RS-positive patients, but it clearly does give us, we think, a really nice commercial opportunity across both segments, but especially in the RS-negative population, which makes that more than 50% of the total patients who have lower risk modest plastic syndrome. Did that get at your question, Matt? It absolutely did. Thank you so much for the call, Eric. I really appreciate it. And Dave or Carol, anything to add to that? No.

Unknown Speaker

Thank you. The only thing I would add is you asked around how Matterhorn informed the Phase III design, and it's obviously been a significant driver of the Phase III design, went through a comprehensive analysis of what variables were driving outcomes, roxa versus placebo, and isolated transfusion burden. as the key variable and have designed the phase 3 trial accordingly. And to Thane's point, the analysis also shows that roxidustat improves transfusion independence and hemoglobin across RS positive and negative. And so that is also reflected in the phase 3 design.

Operator

Okay. That makes sense. Thank you. And our next question will be coming from the line of Michael King of Rodman & Renshaw LLC. Your line is open.

Unknown Speaker

Thanks for taking the question, guys. If I could, I'd like to pivot to 3246 and 3180. of questions on the program I'm just curious how you guys look at it as far as you know I know it's one to two prior lines one prior a RPI but I'm just curious what you anticipate the enrollment might be for individuals who have been treated with lutetium-177, and whether you can, you know, enrich enrollment for that population. The reason I'm asking is I'm trying to think about whether there's any element of the design of the Phase 2 that could... propel you towards some kind of an accelerated approval strategy.

Unknown Speaker

Yes, it's a great question, Mike, and I appreciate the question. I'll go ahead and kick it off, and then Carol, I'll hand it over to you for additional commentary. So to your point, we clearly are allowing prior pluvicto-treated patients into the trial. At the outset of the trial, we kind of had an estimate as it relates to what percent of patients were going to be previous PluVicto-treated patients. far into the trial, while we're not disclosing our enrollment stats yet, what we can say is about 30% of patients who have been enrolled into the trial and randomized were previously treated with Pluvicto. And we've got a pre-specified analysis. based upon prior Plobicto exposure or not. So that we've got that built into the SAP so that we will be able to clearly determine is there any sort of a differential impact or effect from 3246 based upon prior Plobicto exposure. I haven't really thought about the ability to go for accelerated approval in that particular patient population if we showed a really nice benefit, but it's an interesting thought.

Ultimately, we're going to be data-driven based upon the outcome of the phase two trial. So Carol, go ahead.

Unknown Speaker

No additions from my side. I just wonder, has there been any inflection? Because, I mean, I know it's early days, but... Novartis just recently received first line indication. So I wonder if that 30% proportion might increase.

Unknown Speaker

going forward from here? Yes, it very well could. I think what we've found is that, you know, you don't see an immediate or instantaneous adoption, especially in urinary cancer therapy, where ARPIs have been really cemented as standard of care, both in the castration-sensitive phase, as well as if they haven't been previously treated with an ARPI, the castration-resistant phase as well. So it's something we'll continue to keep an eye on. We're closely evaluating the patients who are enrolled to understand, are we seeing an inflection in previously plevictor treated patients? And so it's clearly an important consideration for us.

Unknown Speaker

Yes, I would just add to that, that there is obviously the dynamic around enrollment, and that is obviously also highly driven by the sites in particular and the treatment practice at the individual sites. As we think about the design of a global phase three, we're obviously very closely monitoring market shares in the global market. the pre-CRPC setting and then the metastatic setting to understand eligibility criteria, but also how we set up the control arm and what is the appropriate prior line of therapy. So point well taken around there being a lot of movement in that space.

Unknown Speaker

Yes, yes, yes. Sorry to keep belaboring this point, but one other question I wanted to ask, and that is I know PET imaging is your key guide towards response, but I'm wondering is it possible to get – both pre and post treatment biopsy from these individuals because I'm just curious about the expression, the levels of expression of PSMA prior to therapy and post therapy to see if there's any difference. you know correlation or With with the level of expression with with PSMA sort of are you going to be more active? serving the post PSMA setting less active or you know indifferent to to PSMA the.

Unknown Speaker

No, thanks, Mike. Carol, you want to take that one? Sure, yes, it's certainly a very interesting scientific question, and we're doing a lot in terms of tissue collection, PSMA scans, PET scans, and our 3180 scans, as much as possible to understand how it evolves over time, as you can appreciate there limitations as to the burden that you can put on patients. So it is a bit more on a best effort basis, but it's certainly a key question to address. And what I would also just say is in this disease area, the tissue availability is limited given the disease, often just being bone disease and also tissue availability if soft tissue disease. So we're coming up against some challenges here in terms of disease, but we're doing all we can to address that scientific question. Well, I know the Proxy Cancer Working Group just updated their guidelines to encourage the use of ctDNA. I don't know, are you going to be looking at ctDNA in these patients?.

Unknown Speaker

Correct. Yes, we are. We definitely are. In fact, in the Phase I monotherapy trial, there was a really nice ctDNA effect with FG3246.

Unknown Speaker

Okay. All right. I think I've exhausted my questions for now. Thank you. I appreciate it, Mike.

Operator

And our next question will come from the line of Jay Olson of Oppenheimer. Your line is open, Jay.

Jay Olson

Oh, hey, congrats on all the progress and thanks for taking our questions. We had a couple of questions, starting with 3246. Can you just talk about how you're thinking of positioning and 3246 is a differentiated non-PSMA approach to metastatic CRPCs. Is the greatest opportunity in PSMA low or PSMA negative patients? Or do you see CD46 targeted therapy as potentially complementary to PSMA directed approaches? And then just on rocks from a longer term perspective, how are you thinking about eventually moving into the first line setting? Thank you.

Unknown Speaker

Thanks, Jay. Good to hear from you. Carol, you want to take that one and then I'll add on?.

Unknown Speaker

Sure, yes, I think these are exactly the type of questions we're looking to address with the phase two, and that's why we're allowing prior letitian to understand how responses are similar or different in different patient subpopulations. And to the prior question, we're also doing the scans to really understand where the patient is. fall and where there's the greatest unmet need and where we have the most compelling value proposition for 3180. So I think all strategic options are here on the table and it will ultimately will be data driven. And then to your point around moving up lines, I think that's what we've traditionally used. seen right is is from the post chemo setting into the pre chemo setting into then the to the hormone sensitive setting and so that those are certainly part of our of our life cycle of our life cycle considerations moving forward.

Unknown Speaker

Dane, back to you. Yes, thanks, Carol. And Jay, maybe one other comment. And this just comes from discussions with clinicians in this space. And this isn't based upon dozens of interviews like we would do as we would contemplate a phase three design, but this is speaking with some KOLs. They believe that a PSMA approach will continue to be kind of standard of care in this pre-chemo setting. What they also talk about is with the ARPIs, they're being used more in the castration-sensitive phase, and that clinicians are shying away from this ARPI switch approach just because you only get an incremental four to six months of additional RPFS when you switch from one ARPI to another. And so they think that the PSMA approach, Pluvicto or other PSMA-directed therapies would be standard of care once a patient has progressed on an ARPI.

Once a patient then progresses on a PSMA-directed therapy, then they tend to think about a different target, but they also tend to think about a different modality. So if they were on an RLT that targeted PSMA, they then might think about an ADC that targets a different epitope like CD46. So they wouldn't go from an RLT that targets PSMA to an ADC that targets PSMA. They also may not go from an RLT that targets PSMA to an RLT that targets another epitope. And so, again, that's it's a different question. It's more anecdotal than anything. We'll continue to, as Carol said, explore it. heavily driven by what we see in our phase two trial. But yes, it's something that we think about a lot as we contemplate what a phase three design could look like.

Operator

Great. Thanks for taking the questions. You bet. And I'd now like to turn the call back to Thayne for closing remarks.

Unknown Speaker

Yes, we appreciate everybody joining us for today's second quarter earnings call and your continued interest in Kindred Bio. Enjoy the rest of your day, guys. And this concludes today's conference call. Thank you for participating. You may now disconnect.

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