RenovoRx Inc (RNXT) 2025 Q2 法說會逐字稿

Good afternoon. I’ll be your conference call operator today. (Operator Instructions) I will now turn the call over to Valter Pinto, Managing Director of KCSA Strategic Communications. Please go ahead.

午安.今天我將擔任您的電話會議接線生。（操作員指示）現在我將把電話轉給 KCSA 策略傳播總經理 Valter Pinto。請繼續。

Thank you, operator, and good afternoon. Welcome everyone to the RenovoRx second quarter 2025 conference call. I’m joined today by RenovoRx's leadership team, including Dr. Ramtin Agah, Chairman, Founder and Chief Medical Officer; Shaun Bagai, Chief Executive Officer; Leesa Gentry, Chief Clinical Officer and Ronald Kocak, VP Controller and Principal Accounting Officer.

謝謝接線員，下午好。歡迎大家參加 RenovoRx 2025 年第二季電話會議。今天與我一起出席的還有 RenovoRx 的領導團隊，其中包括董事長、創始人兼首席醫療官 Ramtin Agah 博士、首席執行官 Shaun Bagai、首席臨床官 Leesa Gentry 和副總裁兼首席會計官 Ronald Kocak。

Before we begin, I’d like to remind everyone that statements made during today’s conference call may be deemed forward looking statements within the meaning of the Safe Harbor of the Private Securities Litigation Reform Act of 1995 and applicable Federal Securities Laws. And that actual results may differ materially and adversely from what is contemplated by such forward looking statements due to a variety of risks, uncertainties and other factors.

在我們開始之前，我想提醒大家，今天的電話會議中所作的陳述可能被視為《1995 年私人證券訴訟改革法案》安全港和適用的聯邦證券法所定義的前瞻性陳述。由於各種風險、不確定性和其他因素，實際結果可能與此類前瞻性陳述所預期的結果有重大不利差異。

The company’s forward looking statements are based on management’s current plans and assumptions and are subject to the risks and uncertainties more fully described in the company’s filings with the SEC. These statements reflect management’s view of current and future market conditions, including but not limited to statements regarding the company’s clinical trials and other research studies, timing for potential additional interim data readouts in full patient enrollment for RenovoRx's ongoing Phase 3 TIGeR-PaC clinical trial studying intra-arterial gemcitabine, also known as IAG.

本公司的前瞻性陳述是基於管理層目前的計劃和假設，並受到公司向美國證券交易委員會提交的文件中更詳細描述的風險和不確定性的影響。這些聲明反映了管理層對當前和未來市場狀況的看法，包括但不限於有關公司臨床試驗和其他研究的聲明，以及 RenovoRx 正在進行的動脈內吉西他濱（也稱為 IAG）3 期 TIGeR-PaC 臨床試驗的全部患者入組時可能額外中期數據讀取的時間。

In locally advanced pancreatic cancer, the potential of the RenovoCath device as a standalone commercial product, or the Transarterial Microperfusion Therapy Platform, also known as TAMP, as a mechanism of action, the anticipated timing for and levels of revenue generation from RenovoCath sales, the company’s commercialization plans in general, the potential for IAG to treat or provide clinically meaningful outcomes for certain medical conditions or diseases, and RenovoRx’s efforts to explore commercialization strategies utilizing the TAM therapy platform.

在局部晚期胰腺癌中，RenovoCath 設備作為獨立商業產品的潛力，或經動脈微灌注治療平台（也稱為 TAMP）作為作用機制的潛力，RenovoCath 銷售的預期時間和創收水平，公司的總體商業化計劃，IAG 治療或為某些醫療狀況或疾病提供有臨床意義的結果的潛力，以及 RenovoRx 治療平台利用商業化策略的努力的潛力，以及 RenovoRx 幫助

For a detailed discussion of material risks and uncertainties facing RenovoRx, refer you to the company’s annual report on Form 10-K for the year ended December 31, 2024, as well as the company’s Investor Presentation and other reports filed periodically with the SEC, including the Form 10-Q for the second quarter 2025, which we just filed with the SEC.

有關 RenovoRx 面臨的重大風險和不確定性的詳細討論，請參閱公司截至 2024 年 12 月 31 日的 10-K 表年度報告，以及公司定期向美國證券交易委員會提交的投資者介紹和其他報告，包括我們剛剛向美國證券交易委員會提交的 2025 年第二季度 10-Q 表。

Except as required by law, RenovoRx disclaims any intention or obligation to update or revise any forward looking statements, whether as a result of new information, future events or otherwise. With that, it’s my pleasure to turn the call over to Dr, Ramtin Agah, Chairman, Founder and Chief Medical Officer of RenovoRx. Ramtin, please go ahead.

除法律要求外，RenovoRx 不承擔更新或修改任何前瞻性聲明的意圖或義務，無論是由於新資訊、未來事件或其他原因。我很高興將電話轉給 RenovoRx 董事長、創辦人兼首席醫療官 Ramtin Agah 博士。Ramtin，請繼續。

Thank you, Valter, and good afternoon, everyone. 2025 thus far has marked the most transformational period in our company history. As everyone knows, late last year we launched the commercialization of RenovoCath device.

謝謝你，瓦爾特，大家下午好。到目前為止，2025 年是我們公司歷史上最具變革性的時期。眾所周知，去年年底我們啟動了RenovoCath設備的商業化。

As a standalone product within its FDA cleared indications for use while we continue to make progress with our Phase 3 TIGeR-PaC study. Our clinical and commercial team have executed well and I could not be more excited about our future.

作為 FDA 批准的適應症內的獨立產品，我們將繼續推進第 3 階段 TIGeR-PaC 研究。我們的臨床和商業團隊表現出色，我對我們的未來感到無比興奮。

Our proprietary Transarterial Microperfusion Therapy Platform or TAMP is designed for targeted therapeutic delivery across the arterial wall near the tumor site to bait the target tumor. By localizing and targeting delivery of therapeutic agents via the peripheral vascular system, TAMP is designed to optimize drug concentration precisely where it is needed.

我們專有的經動脈微灌注治療平台或 TAMP 旨在透過腫瘤部位附近的動脈壁進行標靶治療，以誘捕目標腫瘤。TAMP 旨在透過週邊血管系統定位和標靶輸送治療劑，精確優化所需部位的藥物濃度。

This targeted approach can minimize systemic exposure and toxicities related to chemotherapy and addresses the longstanding challenge in cancer care of poor blood supply to tumor sites. We believe that TAMP, by using the body’s existing microvascular care pathway called the Vasa vasorum for drug delivery, represents a significant advancement in the way cancer treatment can be approached.

這種有針對性的方法可以最大限度地減少化療相關的全身暴露和毒性，並解決癌症治療中長期存在的腫瘤部位血液供應不足的難題。我們相信，TAMP 利用人體現有的微血管護理路徑（稱為血管血管）進行藥物輸送，代表了癌症治療方法的重大進步。

We began commercializing RenovoCath in the fourth quarter of 2024 and with other sales and marketing team we face, we are proud to have achieved over $400,000 in sales in the second quarter, a significant accomplishment in a short period of time.

我們在 2024 年第四季開始將 RenovoCath 商業化，與其他銷售和行銷團隊合作，我們很自豪在第二季度實現了超過 40 萬美元的銷售額，這是在短時間內取得的重大成就。

These initial sales prior to installing the sales and marketing infrastructure highlights the strong clinical market demand for our patented RenovoCath device as a standalone targeted drug delivery product among both new and existing customers. Equally important is our Phase 3 TIGeR-PaC trial.

在安裝銷售和行銷基礎設施之前的這些初始銷售凸顯了新舊客戶對我們專利的 RenovoCath 設備作為獨立標靶藥物傳輸產品的強勁臨床市場需求。同樣重要的是我們的第三階段 TIGeR-PaC 試驗。

The 50 second event in our trial occurred in Q2, triggering the preplanned second interim analysis and reviewed by the independent data monitoring committee known as the DMC, which happened recently. As a reminder, the DMC reviews the trial data and makes recommendation to our company mainly whether the data was compelling enough from their third party point of view to move forward with the trial or not.

我們試驗中的 50 秒事件發生在第二季度，觸發了預先計劃的第二次中期分析，並由最近發生的獨立數據監測委員會（DMC）進行了審查。提醒一下，DMC 會審查試驗數據並向我們公司提出建議，主要是從第三方的角度來看數據是否足夠有說服力以繼續進行試驗。

We’re excited to report that the DMC recently completed the review of our second time interim analysis and has recommended that we continue the study. This is great news as we believe DMC’s recommendation is an expression of confidence in the potential for positive outcome in the trial overall.

我們很高興地報告，DMC 最近完成了對我們第二次中期分析的審查，並建議我們繼續這項研究。這是個好消息，因為我們相信 DMC 的建議表達了對整個試驗取得積極結果的可能性的信心。

With a view towards preserving the integrity of target pack trial for FDA purposes and following our review of general FDA guidance, discussions with the DMC and consultation with regulatory advisors, we have decided to defer publishing our second interim data.

為了維護 FDA 目標包裝試驗的完整性，並在審查了 FDA 一般指南、與 DMC 進行了討論並諮詢了監管顧問之後，我們決定推遲發布第二個中期數據。

Outside of myself, who has been speaking directly with the DMC, our entire team will remain blinded to the interim data. We will revisit publishing the actual second interim data most likely upon completion of this study as is common for pivotal Phase III trials. Meanwhile, the TIGeR-PaC trial is continuing at pace.

除了我自己直接與 DMC 溝通外，我們整個團隊都對中期數據一無所知。我們將重新考慮發布實際的第二個中期數據，這很可能是在本研究完成後進行的，這對於關鍵的 III 期試驗來說很常見。同時，TIGeR-PaC 試驗正在快速進行中。

As of August 12, 2025, 95 patients have been randomized and 61 events have occurred, putting us on target to complete enrollment later this year or early next year. At RenovoRx, our mission remains clear, transform patient outcomes through safer, more effective targeted therapy, especially for those battling difficult to treat cancers like locally advanced pancreatic cancer.

截至 2025 年 8 月 12 日，已有 95 名患者隨機分組，發生 61 起事件，我們的目標是在今年稍後或明年年初完成招募。在 RenovoRx，我們的使命始終明確，透過更安全、更有效的標靶治療來改變患者的治療結果，特別是對於那些與局部晚期胰腺癌等難以治療的癌症作鬥爭的患者。

Thank you all for your continued support. With that, I will turn the call over to our CEO, Shaun Bagai.

感謝大家一直以來的支持。說完這些，我將把電話轉給我們的執行長 Shaun Bagai。

Thank you, Ramtin. As Ramtin mentioned, 2025 has been a breakthrough year for our company and during the second quarter we made meaningful progress commercially and in the clinic. The second quarter showcased the early impact of our commercial strategy and we’re pleased to report second quarter 2025 revenue of over $400,000. We are proud of the initial organic revenue growth over the first two full quarters since launch of RenovoCath commercial sales, especially since this was achieved without a dedicated sales and marketing team.

謝謝你，Ramtin。正如 Ramtin 所提到的，2025 年對我們公司來說是突破性的一年，第二季我們在商業和臨床方面取得了有意義的進展。第二季展示了我們商業策略的早期影響，我們很高興地報告 2025 年第二季的收入超過 40 萬美元。我們對 RenovoCath 商業銷售啟動以來前兩個完整季度的初始有機收入成長感到自豪，尤其是在沒有專門的銷售和行銷團隊的情況下實現這一目標。

With the recent hiring of Phil Stocton as our Senior Director of Sales and Market Development, our goal is to stay lean while also continuing to build commercialization momentum. We will continue to gather important data about our market such as sales cycles, activation times, individual customer preferences, and other commercial matters as we seek to grow our customer base, fulfill repeat RenovoCath orders and position ourselves for commercial growth over the longterm.

我們最近聘請了 Phil Stocton 擔任銷售和市場開發高級總監，我們的目標是保持精簡，同時繼續建立商業化勢頭。我們將繼續收集有關我們市場的重要數據，例如銷售週期、啟動時間、個人客戶偏好和其他商業事項，因為我們尋求擴大我們的客戶群，履行重複的 RenovoCath 訂單，並為長期商業成長做好準備。

We believe RenovoCath is positioned to address a significant unmet need in oncology supported by a compelling market opportunity as an innovative approach to drug delivery. Our commercial vision and internal market analysis continue to support an initial US total addressable market for RenovoCath as a standalone device has an estimated initial $400 million peak annual US sales opportunity.

我們相信，RenovoCath 作為一種創新的藥物輸送方法，能夠滿足腫瘤學領域尚未滿足的重大需求，並得到極具吸引力的市場機會的支持。我們的商業願景和內部市場分析繼續支持 RenovoCath 作為獨立設備的初始美國總可尋址市場，預計初始年度美國銷售高峰機會為 4 億美元。

Beyond historical RenovoCath usage, we are already beginning to see interest in the adoption of our technology for the treatment of other solid tumors through our commercial efforts. This broad interest serves as the basis for our belief in the potential for a several billion dollar total addressable market for the RenovoCath device alone as we expand into additional cancer applications.

除了 RenovoCath 的歷史用途之外，我們已經開始看到人們對透過商業努力採用我們的技術來治療其他實體腫瘤的興趣。這種廣泛的興趣使我們相信，隨著我們擴展到其他癌症應用領域，僅 RenovoCath 設備就具有數十億美元的總潛在市場。

On the clinical front as Ramtin mentioned, we received a positive independent DMC recommendation to continue our Phase 3 TIGeR-PaC trial based on interim data review. We are very excited about this development and what it means for the future prospects of our Phase 3 trial. I would now like to turn the call over to Leesa Gentry, our Chief Clinical Officer, who will elaborate our clinical programs. Leesa?

正如 Ramtin 所提到的，在臨床方面，我們收到了獨立的 DMC 的積極建議，根據中期數據審查，繼續進行 3 期 TIGeR-PaC 試驗。我們對這一進展以及它對我們第三階段試驗的未來前景的意義感到非常興奮。現在，我想將電話轉給我們的首席臨床官 Leesa Gentry，她將詳細說明我們的臨床計劃。莉莎？

Thank you, Shaun. To reiterate, the DMC has recommended that RenovoRx continue the TIGeR-PaC trial following their review of the preplanned second interim analysis, which was triggered at the 50 second event.

謝謝你，肖恩。重申一下，DMC 在審查了在 50 秒事件中觸發的預先計劃的第二次中期分析後，建議 RenovoRx 繼續進行 TIGeR-PaC 試驗。

As Ramtin mentioned, as of August 12, 2025, we have randomized 95 patients and 61 events have occurred, keeping us on track to complete enrollment later this year or early next year. The trial design calls for 114 patients to be randomized and the final TIGeR-PaC analysis will be triggered upon the 86th event. We are also advancing our research pipeline.

正如 Ramtin 所提到的，截至 2025 年 8 月 12 日，我們已經隨機分組了 95 名患者，發生了 61 起事件，這使我們能夠在今年晚些時候或明年年初完成招募。試驗設計要求隨機分配 114 名患者，並將在第 86 次事件發生時觸發最終的 TIGeR-PaC 分析。我們也在推進我們的研究進程。

Last week, we announced the launch of our multicenter post marketing registry study called PanTheR to follow patients undergoing cancer treatment delivered by PanTheR to solid tumors. The PanTheR study is an important initiative aimed at evaluating the safety and effectiveness of RenovoCath in real world clinical settings.

上週，我們宣布啟動名為 PanTheR 的多中心上市後註冊研究，以追蹤接受 PanTheR 治療實體瘤的癌症患者。PanTheR 研究是一項重要舉措，旨在評估 RenovoCath 在真實臨床環境中的安全性和有效性。

This study is designed to assess long term safety and survival outcomes in patients with solid tumors who receive targeted drug delivery via RenovoCath. By collecting real world data on the use of RenovoCath across a broader range of tumor types, the PanTheR study aims to provide valuable insights into patient outcomes and support the generation of additional safety data. PanTheR marks a significant step forward in our commitment to better understand and demonstrate the long term safety and therapeutic potential of our RenovoCath device.

這項研究旨在評估透過 RenovoCath 接受標靶藥物輸送的實體腫瘤患者的長期安全性和存活結果。PanTheR 研究旨在收集有關在更廣泛的腫瘤類型中使用 RenovoCath 的真實世界數據，為患者結果提供有價值的見解並支持產生額外的安全數據。PanTheR 標誌著我們在更好地理解和展示 RenovoCath 設備的長期安全性和治療潛力方面邁出了重要一步。

And now I will turn it back to Shaun.

現在我將把話題轉回給肖恩。

Thanks, Leesa. You and your team have done a wonderful job with our Phase 3 trial. We are excited about the continued validation of our platform, progress of our commercial strategy and strong execution by our team.

謝謝，Leesa。您和您的團隊在我們的第三階段試驗中表現非常出色。我們對我們的平台的持續驗證、商業策略的進展以及我們團隊的強大執行力感到興奮。

Additionally, each cancer center participating in the registry study will purchase RenovoCath devices from RenovoRx for use in the study. With that I’ll turn the call over to Ron Kocak, our Vice President Controller and Principal Accounting Officer to review the financials before Q and A. Ron?

此外，參與註冊研究的每個癌症中心將從 RenovoRx 購買 RenovoCath 設備進行研究。這樣，我將把電話轉給我們的副總裁財務主管兼首席會計官 Ron Kocak，讓他在問答之前審查財務狀況。 Ron？

Thank you, Shaun. For the second quarter of 2025 ending June 30, RenovoRx reported revenues of approximately $422,000 from commercial sales of RenovoCath driven by new customer purchase orders and early repeat orders from our initial sites.

謝謝你，肖恩。截至 6 月 30 日的 2025 年第二季度，RenovoRx 報告稱，RenovoCath 商業銷售收入約為 422,000 美元，這主要得益於新客戶採購訂單和我們初始站點的早期重複訂單。

Research and development expenses were $1.4 million for the second quarter, reflecting a $0.1 million decrease from the same quarter year-over-year. The decrease is primarily due to other clinical and regulatory expenses including an allocation of selling, general and administrative expenses of $0.2 million. This decrease was offset by an increase in non-recurring engineering costs on our RenovoCath device of $0.1 million.

第二季研發費用為 140 萬美元，較去年同期減少 10 萬美元。下降的主要原因是其他臨床和監管費用，包括分配 20 萬美元的銷售、一般和行政費用。這一減少被我們的 RenovoCath 設備的非經常性工程成本增加 10 萬美元所抵消。

Selling, general and administrative expenses were approximately $1.5 million remaining unchanged from the same quarter last year. We ended the quarter with $12.3 million in cash and cash equivalents on hand. We anticipate revenues from RenovoCath sales orders to reduce our burn rate over time.

銷售、一般及行政開支約 150 萬美元，與去年同期相比維持不變。本季末，我們手頭上有 1,230 萬美元的現金和現金等價物。我們預計 RenovoCath 銷售訂單的收入將隨著時間的推移降低我們的資金消耗率。

We believe that cash as of June 30, 2025, will fully fund both ongoing RenovoCath commercial scale up efforts and additional progress towards the completion in the Phase 3 TIGeR-PaC trial. Common shares outstanding as of August 11, 2025, totaled 36,645,884.

我們相信，截至 2025 年 6 月 30 日的現金將完全資助正在進行的 RenovoCath 商業擴大規模工作以及完成第 3 階段 TIGeR-PaC 試驗的進一步進展。截至 2025 年 8 月 11 日，流通普通股總數為 36,645,884 股。

With that, I will turn the call back to the operator for Q and A. Operator, please open the line for questions.

說完這些，我將把電話轉回給接線生進行問答。接線員，請開通熱線以回答問題。

(Operator Instructions)

（操作員指示）

Scott Henry, AGP.

斯科特·亨利（Scott Henry），AGP。

Thank you. Good afternoon. Certainly, a lot to talk about. I guess just for clarification, the decision was to maintain the trial at the same number of patients. I know sometimes they can add patients. It sounds like they did not, but just want clarify that.

謝謝。午安.當然，有很多事情要談。我想只是為了澄清一下，決定是維持試驗中相同數量的患者。我知道有時他們可以增加病人。聽起來他們沒有，但我只是想澄清這一點。

Yeah. Thanks for the -- hey, Scott, thanks for the question. Yeah, that’s a good thing to point out is that the DMC feedback we got seem very positive and maintaining the same number sample size, the same number of patients. So we did not add patients to the trial.

是的。謝謝——嘿，斯科特，謝謝你的提問。是的，值得指出的是，我們收到的 DMC 回饋似乎非常積極，並且保持了相同的樣本量和相同的患者數量。因此我們沒有增加患者參與試驗。

Okay, great. And I know after the first analysis, did comment on a lot of the data, but not the second analysis. Is that because it’s closer to the end? Is there any kind of reason why kind of was okay the first time, but not the second time? I certainly understand that’s the way a lot of these things work, but I just wanted to hear your thoughts.

好的，太好了。我知道在第一次分析之後，確實對很多數據進行了評論，但第二次分析卻沒有。是因為已經接近尾聲了嗎？有什麼原因導致第一次還可以，但第二次不行嗎？我當然知道很多事情都是這樣運作的，但我只是想聽聽你的想法。

Yeah, Scott, you nailed it. As a reminder, we had very significant or positive results from our Phase 1/2 trial showing a potential for increasing the lifespan of pancreatic cancer patients, and really reducing the side effects and toxicities. This allowed us and gave us the confidence to jump straight into a Phase 3 randomized, which should be a pivotal trial. And the FDA agreed that based on our preliminary data from the Phase 1/2 trials, we could jump to a Phase 3. In most circumstances, you do a prospective Phase 2 trial to help inform the design with that confidence.

是的，史考特，你成功了。提醒一下，我們的 1/2 期試驗取得了非常顯著或正面的結果，顯示出延長胰臟癌患者壽命的潛力，並真正減少副作用和毒性。這讓我們有信心直接進入第三階段隨機試驗，這應該是一項關鍵的試驗。FDA 同意，根據我們第 1/2 階段試驗的初步數據，我們可以進入第 3 階段。在大多數情況下，您會進行前瞻性的第 2 階段試驗，以協助以信心告知設計。

We went to the Phase 3, not having done the Phase 2, taking a very early look, i.e., 30% of the data would give us confidence that we are on the right track almost in lieu of a Phase 2 trial. And being that early in the study, we didn’t feel like it would bias or jeopardize the study in any way. And you nailed it now that we’re getting nearing the end of the trial. And already there’s enthusiasm for the potential positivity. We didn’t want to introduce any bias at this late stage in the game.

我們進入了第 3 階段，沒有進行第 2 階段，進行了非常早期的觀察，即 30% 的數據可以讓我們相信我們幾乎在代替第 2 階段試驗的正確軌道上。由於研究還處於早期階段，我們並不認為這會對研究造成任何偏見或傷害。現在審判已經接近尾聲，你說得非常對。人們已經對潛在的積極性產生了熱情。我們不想在遊戲的後期引入任何偏見。

How close you are to the finish line and the DMC’s confidence to move forward to completion and then potential preparation of an NDA filing and to protect the integrity of the trial, made sense to keep this with the highest chance of success with the FDA at the end.

您距離終點線有多近，以及 DMC 是否有信心繼續完成並可能準備 NDA 申請，以及保護試驗的完整性，最終與 FDA 保持最高的成功機會是有意義的。

Okay, makes sense. Certainly. And then, looks like you need to enroll 19 more patients. The pace of the past few months would seem to indicate that that could reach till kind of mid-2026, but it sounds like you think it could be a little bit earlier. Are you expecting kind of a ramp up? Is it kind of the fall? Maybe it’s slow in the summer. But it seems like the enrollment pace is expected to increase near term.

好的，有道理。當然。然後，看起來您需要再招募 19 名患者。過去幾個月的速度似乎表明這可能會持續到 2026 年中期，但聽起來您認為可能會更早一點。您是否期待出現某種程度的上升？是不是有點像秋天？也許夏天比較慢。但看起來入學速度預計近期會增加。

Yes, Scott, thanks for the question. A couple of things to keep in mind is in terms of enrollment, we do enroll patients treatment naive. We then go through an induction phase to weed out patients that might have micrometastasis and then randomized truly locally advanced pancreatic cancer patients. So there is kind of a fallout in that middle phase. So we’ve randomized 95 to date, need to randomize 114 to stop the study, or to complete enrollment randomization.

是的，斯科特，謝謝你的提問。在招募方面需要記住的幾件事是，我們確實招募了未接受過治療的患者。然後，我們經過誘導階段，淘汰可能出現微轉移的患者，然後隨機分配真正的局部晚期胰臟癌患者。因此，中間階段會產生某種後果。因此，到目前為止，我們已經隨機化了 95 人，需要隨機化 114 人才能停止研究，或完成入組隨機化。

So enrollment completion is what we’re aiming for. And that we anticipate to be towards the end of the year or first quarter next year. As far as a ramp goes, you’re 100% correct. We’ve added some larger volume, more well known cancer centers in the last several months, including University of Nebraska, Northwell, Johns Hopkins. As we anticipate that with these larger cancer centers, we should start to see a ramp we’re coming out of the summer.

因此，我們的目標是完成入學。我們預計這一時間將在今年年底或明年第一季。就坡道而言，您 100% 正確。在過去的幾個月裡，我們增加了一些規模更大、更知名的癌症中心，包括內布拉斯加大學、諾斯韋爾大學和約翰霍普金斯大學。正如我們預期的那樣，隨著這些大型癌症中心的出現，我們應該開始看到夏季癌症治療數量的上升。

So it’s a combination of getting enrollment done to be able to randomize that the 114 patient and these new centers coming on board in the recent past to help accelerate enrollment towards the end the year, if not the beginning of next year.

因此，需要結合完成入組工作以便能夠隨機分配 114 名患者，以及最近加入的這些新中心，以幫助加速在年底甚至明年年初完成入組。

Okay, great. Just a final question, then I’ll jump into the queue. On the PanTheR trial, when should we see data coming out of that?

好的，太好了。最後一個問題，然後我就加入隊列了。關於 PanTheR 試驗，我們什麼時候可以看到數據？

It’s interesting. It’s a broad based post market device registry. And so there’s not as pre specified endpoint with data. As investigators and the company sees interesting findings. We can publish and present on podiums data along the way.

這很有趣。它是一個廣泛的上市後設備註冊系統。因此，沒有預先指定的資料端點。正如調查人員和公司所看到的有趣的發現。我們可以在講台上發布並展示沿途的數據。

One of the exciting aspects of the PanTheR study, it is a solid tumor registry. And while our experience to date has not fully, but been primarily in pancreatic cancer, it does allow us to collect capture and then present on data outside of pancreatic cancer.

PanTheR 研究的一個令人興奮的方面是，它是一個實體腫瘤登記處。雖然我們迄今為止的經驗還不全面，但主要集中在胰臟癌方面，它確實使我們能夠收集並呈現胰臟癌以外的數據。

So as we start to see either trends in usage or trends and results, we start can to publish and present data along the way. So not a great answer in terms of timing, but it is imminent. And we look forward to being able to explore the use of the RenovoCath technology beyond where we’ve seen it to date. And another interesting aspect about the PanTheR trial is that these centers will be purchasing devices to be able to use to explore further uses of the RenovoCath, which could help with revenue as well.

因此，當我們開始看到使用趨勢或趨勢和結果時，我們就可以開始發布和呈現數據。因此，從時間角度來看這不是一個很好的答案，但它即將到來。我們期待能夠進一步探索 RenovoCath 技術的用途。PanTheR 試驗的另一個有趣的方面是，這些中心將購買設備，以便能夠探索 RenovoCath 的進一步用途，這也有助於增加收入。

Okay, great. Thank you for taking the questions and congratulations on a lot of progress in the past few months.

好的，太好了。感謝您回答問題，並祝賀您在過去幾個月中取得的巨大進步。

Thank you, Scott.

謝謝你，斯科特。

Edward Wu, Ascendiant Capital Markets. Please proceed with your question.

Edward Wu，Ascendiant Capital Markets。請繼續您的問題。

Hi, it’s Raffafer for Edward Woo, Ascendiant Capital Markets. Can you give an update on you previously mentioned partnering with the top 200 cancer centers?

大家好，我是 Ascendiant Capital Markets 的 Edward Woo 的 Raffafer。您能否介紹一下先前提到的與前 200 家癌症中心合作的最新情況？

Yeah, thanks for the question. Great to talk to you. Thanks for calling in. So as I’ve kind of outlined in terms of market potential, there are about 200 cancer centers across the US that treat the majority of non-metastatic GI solid tumors. So it’s a good example market for us for pancreatic cancer.

是的，謝謝你的提問。很高興和你談話。謝謝您的來電。正如我在市場潛力方面所概述的，美國大約有 200 個癌症中心，治療大多數非轉移性胃腸道實體瘤。所以對我們來說，這是一個很好的胰臟癌示範市場。

And the way I’ve characterized these 200 centers is it wouldn’t take a large sales force to attack them. And as we operate in this commercial environment, very leanly without hiring a large expensive sales force, we’re able to have deep penetration in the broader market by focusing on some of these top centers.

我對這 200 個中心的描述是，不需要龐大的銷售團隊來攻擊它們。而且，由於我們在這種商業環境中精簡運營，無需僱用大量昂貴的銷售人員，因此我們能夠透過專注於其中一些頂級中心，在更廣泛的市場中實現深度滲透。

We’ve already made announcements that we’re in 13 hospitals with back approvals, which means that the hospitals are approved to purchase the device or already issued purchase orders RenovoCath with our early commercial efforts.

我們已經宣布，我們已在 13 家醫院獲得了批准，這意味著這些醫院已獲準購買該設備，或者已經透過我們的早期商業努力向 RenovoCath 發出了採購訂單。

Those 13 centers are some of the top 200 large volume cancer centers across the US, 4 of which have started using the device, treating patients and having reorders as well. As far as using their names publicly, we did mention a couple of centers, including Hackensack Medical Center in New Jersey.

這 13 家中心是美國排名前 200 位的大型癌症中心之一，其中 4 家已開始使用該設備治療患者並接受重新訂購。至於公開使用他們的名字，我們確實提到了幾個中心，包括新澤西州的哈肯薩克醫療中心。

And as we get permission to use names, we’ll start publishing more on exactly which centers we’re partnering with. We are also on the verge of launching a RenovoCath website, where patients can go to define which centers are offering the technology. So in the not too distant future, you’ll be able to see which centers are involved as well, once we get permission to use your name to help drive patients towards centers to be able to receive treatment.

當我們獲得使用名稱的許可時，我們將開始發布更多關於我們合作中心的具體資訊。我們也即將推出 RenovoCath 網站，患者可以透過該網站了解哪些中心提供該技術。因此，在不久的將來，一旦我們獲得使用您的名字的許可，您將能夠看到哪些中心參與其中，以幫助吸引患者前往中心接受治療。

Okay, great. Can you also discuss any plans for the RenovoCath for international markets?

好的，太好了。您能討論一下 RenovoCath 針對國際市場的計畫嗎？

Yeah, it’s an interesting topic. The reimbursement tailwinds and the cost of doing business here in the US and the large market and unmet need here, we’re hyper focused on the US market first. We do anticipate down the road once we establish the US market to explore internationally. There is a large volume of cancer patients without great technologies or therapies across Europe and different Asian countries as well. We’ve begun to have dialogues with investigators there over the years and also potential partners. So as we start to really get traction in the US, we’ll further explore outside the US markets either with a partner or on our own.

是的，這是一個有趣的話題。由於報銷順風和在美國開展業務的成本以及這裡巨大的市場和未滿足的需求，我們首先高度關注美國市場。我們確實期望一旦建立美國市場，我們就能開拓國際市場。歐洲和亞洲各國都存在大量缺乏先進技術或治療方法的癌症患者。多年來，我們已經開始與那裡的調查人員以及潛在合作夥伴進行對話。因此，當我們開始在美國真正獲得發展動力時，我們將與合作夥伴或自行進一步探索美國以外的市場。

Great. Thank you very much.

偉大的。非常感謝。

Thanks for the questions, Ed.

謝謝你的提問，艾德。

(Operator Instructions)

（操作員指示）

Swayampakula with H. C. Wainwright. Please proceed with your question.

Swayampakula 和 H.C. Wainwright。請繼續您的問題。

Thank you. This is RK from H. C. Wainwright. Good afternoon, Shaun. So looking at your revenues of $422,000, I’m just trying to figure out is any of it, any of the revenues coming from purchasing for the clinical studies itself or is all of it really commercial dollars?

謝謝。這是來自 H. C. Wainwright 的 RK。下午好，肖恩。因此，看看你們 422,000 美元的收入，我只是想知道其中是否有任何收入來自臨床研究本身的購買，還是全部都是商業收入？

Okay, this is a great question. I really appreciate you asking them because it’s a great delineation. This is all non--PaC Phase 3 revenue. So these are all brand new customers who were outside of the clinical trial or outside usage of the trial. Any revenues and we do charge for the catheter and it is reimbursed within the Phase 3 TIGeR-PaC trial. But any revenues from those are not recognized as revenue, but considered an R&D offset, which you can see from our filings. So it is important to note that the revenue stream is all external to TIGeR-PaC.

好的，這是一個很好的問題。我真的很感謝你問他們這個問題，因為這是一個很好的描述。這些都是非 PaC 第三階段的收入。因此，這些都是臨床試驗以外或試驗使用範圍之外的全新客戶。任何收入我們都會對導管收費，並在第三階段 TIGeR-PaC 試驗中報銷。但這些產生的任何收入都不被確認為收入，而是被視為研發抵消，您可以從我們的文件中看到這一點。因此，值得注意的是，收入來源全部來自 TIGeR-PaC 外部。

As mentioned earlier in Scott’s question, we do aim to complete enrollment towards the end of this year, beginning of next year. After that, those 18 centers that are in the TIGeR-PaC trial can and most likely will convert to commercial paying customers, where they can start treating patients with various elements or tumors using the device. And those purchases will be revenue towards a company in terms of revenue recognition.

正如斯科特在前面的問題中提到的，我們的目標是在今年年底或明年年初完成招生。此後，參與 TIGeR-PaC 試驗的 18 個中心可以（並且很可能會）轉變為商業付費客戶，他們可以開始使用該設備治療患有各種元素或腫瘤的患者。從收入確認的角度來看，這些購買將成為公司的收入。

So the TIGeR-PaC sites using catheters does help our bottom line, but the $422,000 just announced does not include any of that revenue recognition. On the flip side, because the PanTheR study is a post market device registry revenue obtained for the PanTheR sites will count towards a revenue recognition.

因此，使用導管的 TIGeR-PaC 站點確實有助於我們的盈利，但剛剛宣布的 422,000 美元並不包括任何收入確認。另一方面，由於 PanTheR 研究是上市後設備註冊研究，因此 PanTheR 站點獲得的收入將計入收入確認。

Okay, and then so on PanTheR study, since it’s a registry study, so do you really have a specific number of centers or anything like that? Or it obviously depends upon which center wants to run this, utilize the device and be part of the registry. How does that work?

好的，那麼關於 PanTheR 研究，由於它是一項註冊研究，那麼您真的有具體數量的中心或類似的東西嗎？或者顯然取決於哪個中心想要運行它、利用該設備並成為註冊表的一部分。這是如何運作的？

It’s relatively open. So we don’t have a specific small, limited number of patients or centers. As we’re discussing with centers, there’s academic interest in collecting data around certain patient populations, we’ll partner with them. So it’s not limited. We are also looking at investigator initiated trials.

它相對開放。因此，我們沒有特定數量的患者或中心。正如我們與中心討論的那樣，學術界對收集特定患者群體的數據感興趣，我們將與他們合作。所以它不受限制。我們也關注研究者發起的試驗。

There are some very interesting research ideas outside of where we’ve seen usage so far that would most likely fall under the registry or an IIT. And those don’t have to be mutually exclusive. We could also perform investigator initiated studies within the registry and use those research ideas.

除了我們目前看到的用途之外，還有一些非常有趣的研究想法，它們很可能屬於註冊表或 IIT 範疇。而這些不一定是互相排斥的。我們也可以在登記處內進行研究者發起的研究並使用這些研究想法。

That gives us a lot of leeway and optionality in terms of what patients might be studied. And then subsequently, what data might be published or presented to show where the RenovoCath can really help patients and really push the science behind this, and also help us capture additional hospitals with academic interests in these areas.

這為我們在選擇研究對象方面提供了很大的自由度和選擇性。隨後，可能會發布或展示哪些數據來表明 RenovoCath 能夠真正幫助患者並真正推動其背後的科學發展，同時也幫助我們吸引更多對這些領域有學術興趣的醫院。

And then for the PanTheR study, I know you’re not really started bringing in patients, but in general, when you started talking with your advisors and whatnot, what sort of solid tumors were they thinking could be a good possibility for the utility of the RenovoCath?

對於 PanTheR 研究，我知道您還沒有真正開始接收患者，但總的來說，當您開始與您的顧問等交談時，他們認為哪種實體腫瘤可能適合使用 RenovoCath？

I really appreciate this question because given the success we’ve seen in pancreatic cancer, there is a vast interest beyond what we studied primarily specifically locally advanced pancreatic cancer. The biggest few interests have been one in locally advanced pancreatic cancer following [FOLFIRINOX] treatment. As most are aware, the Phase 3 trial design has a gemcitabine plus [Abraxane] Induction Phase. Many patients opt for FOLFIRINOX, the younger, healthier patients. And so coupling local treatment with the FOLFIRINOX induction is of interest.

我非常感謝這個問題，因為鑑於我們在胰腺癌治療中取得的成功，人們對我們主要研究的局部晚期胰腺癌之外的領域產生了濃厚的興趣。最大的興趣之一是 [FOLFIRINOX] 治療後的局部晚期胰腺癌。眾所周知，第 3 階段試驗設計有一個吉西他濱加 [Abraxane] 誘導階段。許多患者選擇 FOLFIRINOX，更年輕、更健康的患者。因此，將局部治療與 FOLFIRINOX 誘導相結合是令人感興趣的。

Also exploring the use of the technology beyond locally advanced pancreatic cancer, for example, in resectable in the neoadjuvant setting or borderline resectable pancreatic cancer patients. There’s also an interest in setting or using the device in metastatic pancreatic cancer patients.

也探索了該技術在局部晚期胰腺癌以外的應用，例如在新輔助治療中可切除或邊緣可切除的胰腺癌患者中。人們也對在轉移性胰腺癌患者中設置或使用該設備感興趣。

Physicians are saying that patients with a single metastases or multiple metastases local control could be important, or could even have effects on the immune system with different agents as they try different agents through device as well. So those have been some of the top research and ideas and interests. Beyond pancreatic cancer, the most common requests or discussion is around cholangiocarcinoma or bile duct cancer.

醫生表示，對於單一轉移或多個轉移的患者來說，局部控制可能很重要，或者當他們透過設備嘗試不同的藥物時，不同的藥物甚至可能對免疫系統產生影響。這些就是一些頂尖的研究、想法和興趣。除了胰臟癌之外，最常見的要求或討論是關於膽管癌或膽管癌。

Given the similar nature of these tumors being hypovascular, having less blood supply, and also using the same drugs like Gemcitabine for example, to treat. And there’s also been an interest in studying bile duct cancers. Beyond that, there’s been interest in certain subsets of non-small cell lung cancer, sarcomas, head and neck tumors. It’s great to see this level of interest across different specialties based on our early success in pancreatic cancer.

鑑於這些腫瘤的相似性質，即血管減少、血液供應較少，也使用相同的藥物（例如吉西他濱）進行治療。人們也對研究膽管癌很感興趣。除此之外，人們也對某些非小細胞肺癌、肉瘤、頭頸部腫瘤感興趣。基於我們在胰臟癌治療方面早期取得的成功，我們很高興看到不同專業領域對此表現出如此高的興趣。

So at one point we were talking about how outside of the chemotherapy additional drugs or drug categories could be also be part of the Renault cap. Do you envisage that sort of data in between this PanTheR study or is it going to be purely the typical chemotherapy that you’re currently using within the TIGeR-PaC study?

因此，我們一度討論過，除了化療之外，其他藥物或藥物類別也可以成為雷諾上限的一部分。您是否設想在 PanTheR 研究中獲得此類數據，或者它是否純粹是您目前在 TIGeR-PaC 研究中使用的典型化療？

I do beyond other tumor types. That’s exactly what will be studied is other agents as well. So there’s been interest from physicians to move beyond or in addition to gemcitabine either with multiple therapies or other drugs that might be more caustic or toxic to the body.

我確實超越了其他腫瘤類型。這也正是其他藥劑所要研究的。因此，醫生有興趣在吉西他濱的基礎上採用多種療法或其他可能對身體更具腐蝕性或毒性的藥物。

For example, platinum based drugs are big interest and one of the biggest limitations of systemic FOLFIRINOX. Beyond that, there are several class of immunotherapeutics that have been tried, tested and failed in pancreatic cancer and other tumors.

例如，鉑類藥物備受關注，但這也是全身性 FOLFIRINOX 治療的最大限制之一。除此之外，還有幾類免疫療法已經在胰臟癌和其他腫瘤中嘗試、測試但失敗了。

One of the reasons is because of this desmoplastic barrier, high pressure and really tumor resistance and lack of blood vessels feeding the tumor. And we overcome that with our TAMP system and with the Renovo cath.

原因之一是由於這種促纖維化屏障、高壓和真正的腫瘤抵抗以及缺乏為腫瘤供血的血管。我們利用 TAMP 系統和 Renovo 導管克服了這個問題。

So being able to deliver different agents that might have an immunotherapeutic effect to turn on the body’s immune system to attack metastatic disease can really open up a large potential for patients. So the registry both in and of itself, and then also the IITs that we’re discussing and negotiating with physicians, both give us an avenue to look into these areas and collect data and present data in these areas beyond just gemcitabine and beyond just locally advanced pancreatic cancer.

因此，能夠提供具有免疫治療作用的不同藥物，啟動人體免疫系統來攻擊轉移性疾病，確實能為患者帶來巨大的潛力。因此，註冊中心本身以及我們正在與醫生討論和協商的 IIT 都為我們提供了研究這些領域、收集數據和呈現數據的途徑，這些數據不僅限於吉西他濱和局部晚期胰腺癌。

Okay, so the last question I know I’ve taken a lot of your time, but the last question from me is bringing on Board, Phil Stocton. So what should we expect now that you have a carrier sales senior executive? Should we expect say three months or six months down the line, the trajectory of revenue to be much better or is his responsibility more to get ready when you get through the TIGeR-PaC and get through any additional FDA approvals?

好的，最後一個問題，我知道我佔據了大家很多時間，但我的最後一個問題是請 Phil Stocton 加入董事會。那麼，現在您有一位營運商銷售高階主管，我們該期待什麼呢？我們是否應該預期三個月或六個月後收入軌跡會好得多，或者他的責任是否更多地是在通過 TIGeR-PaC 並獲得任何額外的 FDA 批准時做好準備？

I appreciate the question RK, it’s the former. Given the early traction we saw, and we posted, I believe two good quarters so far but primarily grassroots efforts on the behalf of me and some of my team members without having a sales and marketing team in place. Given that we can see the upside in market penetration and potential to drive revenues to a level that would support the company at some point in time, bringing on fill to bring on a small team to really start ramping for commercialization efforts now makes sense. And that’s for the pure RenovoCath not needing to wait for the drug device combination and TIGeR-PaC.

我很感謝 RK 提出的問題，是前者。鑑於我們早期看到的和發布的進展，我相信到目前為止兩個季度都表現良好，但主要是我和我的一些團隊成員在沒有銷售和行銷團隊的情況下進行的基層努力。鑑於我們可以看到市場滲透率的上升空間以及將收入推高至可在某個時間點支持公司發展的水平的潛力，因此引入一個小團隊來真正開始加大商業化努力現在是有意義的。這是因為純 RenovoCath 不需要等待藥物裝置組合和 TIGeR-PaC。

The goal is to have the team fully in place and positioned by the end of the year. So I anticipate continuing revenue over the year, but really gearing up for success in 2026 to start driving towards profitability at some point in time or cash flow breakeven as that team gets in place and we drive market penetration.

我們的目標是在今年年底前讓團隊完全到位並做好準備。因此，我預計今年的收入將持續成長，但真正為 2026 年的成功做好準備，隨著團隊到位和市場滲透的推進，我們將在某個時間點開始實現盈利或現金流收支平衡。

I see 2025 with fill at the helm, really learning the sales cycle, the activation timelines, collecting other sales metrics on how we can optimize that and then really plan for more of a full penetration and launch in 2026 into some of those 200 accounts as alluded to.

我認為 2025 年將由填充來掌舵，真正了解銷售週期、激活時間表，收集其他銷售指標以了解如何優化這些指標，然後真正計劃在 2026 年更全面地滲透並推出上述 200 個帳戶中的一些帳戶。

Okay. Thank you. Thanks for taking all my questions, Shaun.

好的。謝謝。謝謝你回答我的所有問題，肖恩。

Thanks, RK. I appreciate the questions.

謝謝，RK。我很感謝你們提出這些問題。

Jason McCarthy, Maxim Group.

傑森麥卡錫，馬克西姆集團。

Hi, guys. This is Chad on for Jason. Thanks for taking the questions. We were wondering, have you guys engaged or plan to engage with FDA regarding a potential accelerated approval pathway?

嗨，大家好。這是 Chad 代替 Jason 上場的。感謝您回答這些問題。我們想知道，你們是否已經與 FDA 接洽或計劃與 FDA 接洽，探討潛在的加速審批途徑？

Thanks for the question, Chad. So from the DMC readout, the goal is to complete the study as an overall survival study. The plan would be as we prepare for an NDA to engage at that time with the FDA to see if there’s an accelerated approval, given the unmet need and failed treatments in pancreatic cancer, getting this from trial completion to potential approval as fast as possible makes sense. So short answer to your question is yes, as we start narrowing final data, we will engage with the FDA to see if acceleration is a possibility.

謝謝你的提問，查德。因此，從 DMC 讀數來看，目標是將研究作為一項總體生存研究來完成。我們的計劃是，在準備 NDA 時與 FDA 接洽，看看是否有加速批准，考慮到胰腺癌中未滿足的需求和失敗的治療，盡快從試驗完成到潛在批准是有意義的。所以對你的問題的簡短答案是肯定的，當我們開始縮小最終數據範圍時，我們將與 FDA 合作，看看是否有可能加速。

Okay, got it. Thanks. And then, how does the sixteen month median OS from the first interim compared to outcomes from other trials in the setting that also used induction chemo and [SBRT]?

好的，明白了。謝謝。那麼，第一次中期試驗的 16 個月中位 OS 與同樣使用誘導化療和[SBRT]？

Chad, I appreciate the question because it’s important to see that we’re aligning what we expect this patient population to do. Previous large, randomized studies have shown that locally advanced pancreatic cancer should yield an overall survival from time of diagnosis to and the report outspend anywhere between 12 months to 18 months, or 14 months to 18 months, maybe more contemporary trials.

查德，我很感謝你提出這個問題，因為重要的是要確保我們對這些患者群體的期望一致。先前的大型隨機研究顯示局部晚期胰臟癌從診斷到治療的總存活期應為 12 個月至 18 個月，或 14 個月至 18 個月，或許更多當代試驗也是如此。

So the 15.5 months -- estimated 15.5 months we saw admin control arm in our first interim analysis fits right in the middle of that. Further validation can be seen with the previously completed PANOVA-3 noble cure trial in their trial. I believe they showed 14.2 months in their gemcitabine plus Abraxane control arm and about 16.2 months in their tumor treating fields plus gemcitabine plus Abraxane. So we’re right smack in the middle of what’s expected in local advanced pancreatic cancer.

因此，我們在第一次中期分析中看到的管理控制部門的 15.5 個月（估計為 15.5 個月）正好處於這個範圍的中間。在他們的試驗中，可以透過先前完成的 PANOVA-3 高貴療法試驗看到進一步的驗證。我相信他們在吉西他濱加 Abraxane 對照組中顯示出 14.2 個月，在腫瘤治療領域加吉西他濱加 Abraxane 中顯示出約 16.2 個月。因此，我們正處於局部晚期胰臟癌的預期治療階段。

Now, what’s interesting with the Novocure study is that they were able to achieve local control and a two month survival benefit, which added about a billion dollars of market cap to their company with those types of results. And it really shows both on the finance side and also the physician interest side that the bar is very low for this patient population to have that much success with a two month benefit. We can imagine what we can accomplish achieving much more than that down the road.

現在，Novocure 研究的有趣之處在於，他們能夠實現局部控制和兩個月的生存益處，這些成果為他們的公司增加了約 10 億美元的市值。這確實表明，無論從財務方面還是從醫生的利益方面來看，對於這個患者群體來說，透過兩個月的福利獲得如此大的成功門檻非常低。我們可以想像，未來我們能夠取得比這更大的成就。

Okay, great. Thanks for taking the questions again, and congrats on all the progress.

好的，太好了。感謝您再次回答問題，並祝賀您取得的所有進展。

Thanks, Chad.

謝謝，乍得。

Scott Henry, AGP.

斯科特·亨利（Scott Henry），AGP。

Thank you for the follow-up question. Shaun, I just wanted to ask a couple of questions about the catheter business. Gross margins, I believe they’re 64% in the quarter, which is a pretty high number for this level of revenues. Is that a sustainable number? And where could gross margins get to on the catheter sales? Thank you.

感謝您的後續提問。肖恩，我只是想問幾個關於導管業務的問題。我認為本季的毛利率為 64%，對於這樣的收入水準來說，這是一個相當高的數字。這是一個可持續的數字嗎？導管銷售的毛利率能達到多少？謝謝。

Yes. Scott, I appreciate the question. And that’s one of the benefits and the reasons why we’re deciding to commercialize because this looks like it could be extremely profitable for the organization. As far as the direct margins in terms of the cost of the actual materials building the catheter, generally new medical devices as they start to achieve success, start reaching that 70% to 90% range. And we’re actually in there.

是的。史考特，我很感謝你提出這個問題。這就是我們決定將其商業化的好處之一，也是原因之一，因為這看起來可以為組織帶來極大的利潤。就製造導管的實際材料成本的直接利潤而言，一般來說，新的醫療設備在開始取得成功時，就會達到 70% 到 90% 的範圍。我們確實就在那裡。

So there was additional expenses, I believe reported in the queue, but we believe we’ll keep pushing that higher towards that 70% to 90% range in the not too distant future. So I see the gross margins increasing over time as we scale.

因此，我相信隊列中報告了額外的費用，但我們相信在不久的將來我們會繼續將這一比例推高至 70% 到 90% 的範圍。因此，我看到隨著我們規模的擴大，毛利率也會增加。

Again, this is with the reimbursement in place. This is part of the decision to go ahead and commercialize at this stage in the company’s development process, given the high potential margins of the technology with the current reimbursement landscape.

再次強調，這是在報銷到位的情況下。考慮到該技術在當前報銷情況下的潛在利潤空間較大，這是公司在發展過程的現階段決定繼續商業化的原因之一。

It would seem with these numbers and just looking at the spending, how it compares to prior quarters, that it’s already significant maybe not significantly, but it’s already cash flow positive. And by the time you add these up this team, it should probably still be accretive at that point. Would you agree with that statement?

從這些數字來看，只要看一下支出狀況，與前幾季相比，就會發現雖然不是很明顯，但已經是相當可觀的了，但現金流已經為正。當你把這些加到這個團隊時，它可能仍然應該在那時增值。您同意這個說法嗎？

I do. It’s, looking at the device manufacturing itself, it is accretive. And as mentioned, it doesn’t take a big expensive sales force. And I think that’s really one of the big advantages we have as an emerging commercial medical device organization outside of the Phase 3 trial is that usually the burn is very high and the margins are low. We’ve been able to, as you know, achieve a lot of momentum and success and value creation with very little money.

我願意。從設備製造本身來看，它具有增值性。如同前面所提到的，它不需要龐大而昂貴的銷售團隊。我認為，作為一個新興的商業醫療器材組織，我們在 3 期試驗之外的一大優勢是，通常燒錢的金額很高，但利潤卻很低。如您所知，我們能夠用很少的錢實現巨大的發展勢頭和成功並創造價值。

And with this type of a niche market, very focused market, we could achieve high revenues a handful of sales reps. It’s also important to note that with the reimbursement in place, each patient receives multiple treatments. So once the patient’s identified at a given hospital, they end up receiving between 5 and 10 treatments.

透過這種利基市場，非常集中的市場，我們可以從少數銷售代表那裡獲得高收入。值得注意的是，在報銷政策實施後，每位患者都可以接受多次治療。因此，一旦患者在某家醫院確診，他們最終會接受 5 到 10 次治療。

And so the numbers add up pretty quickly in terms of revenue. So without the need for large sales force, our burn can stay low, but our revenues will continue to ramp through the end of this year and then into the next year as well.

因此，就收入而言，數字很快就會增加。因此，由於不需要龐大的銷售隊伍，我們的成本消耗可以保持在較低水平，但我們的收入將在今年年底甚至明年繼續增長。

Okay, great. And I would be remiss not to give you an opportunity to talk about your thoughts for the rest of the year, the catheter revenue. I’m not trying to get guidance out of you, but would you expect sequential gains in Q3 and Q4? I know sometimes there’s a lot of upfront bolus sales and then you have to wait for reorders, but it seems like reorders are moving. Do you look for would you expect sequential gains in the coming quarters?

好的，太好了。如果我不給你機會談談你對今年剩餘時間導管收入的想法，那我就太失職了。我並不是想從您那裡得到指導，但您是否預計第三季和第四季會出現連續成長？我知道有時會有很多預付大劑量銷售，然後你必須等待重新訂購，但似乎重新訂購正在進行中。您是否預計未來幾季會出現連續成長？

So of course, as you can imagine, with such a new effort, we can’t give guidance currently as I really look at 2025 as a learning year. And I wouldn’t measure success on a quarterly basis, because there will be ups and downs and fluctuations this early in the process, especially since there’s multiple procedures per patient, a couple of patients can really change the needle going from zero, pretty much 43,000 or pretty much zero, just over six months ago to where we’ve achieved so far with 420,000 plus this quarter is fantastic.

所以當然，正如你可以想像的，對於這樣一項新的努力，我們目前無法提供指導，因為我真的將 2025 年視為學習年。我不會以季度為單位來衡量成功，因為在這個過程的早期階段，會出現起伏和波動，特別是因為每個病人要接受多次手術，幾個病人就能真正改變情況，從零開始，大約 43,000 例，或者從六個月前幾乎為零開始，到我們迄今為止取得的 420,000 例以上的成績，這個季度真是太棒了。

I do see us driving hard learning and penetrating deeply, bringing more of those 13 centers across the finish line to start ordering catheters and treating patients. We do have a pipeline another 20 or 30 hospitals behind them. So I do see growth over the next half of the year, but I really see that that ramp start to take place with these few new sales hires as we work on infrastructure right now, more in 2026. So anticipate success throughout the year and then really ramping next year.

我確實看到我們正在努力學習和深入滲透，讓這 13 個中心中的更多中心跨過終點線，開始訂購導管並治療患者。我們確實有一條管道，可以覆蓋另外 20 或 30 家醫院。因此，我確實看到了下半年的成長，但我真正看到的成長是隨著我們現在致力於基礎設施建設而招募的幾名新銷售人員開始出現的，更多的成長將在 2026 年出現。因此，預計全年都會取得成功，然後明年會真正取得進展。

Okay, great. Thank you for taking the questions.

好的，太好了。感謝您回答這些問題。

Thanks, Scott. I appreciate it.

謝謝，斯科特。我很感激。

Steven Reed, KIT Investments.

史蒂文·里德​​（Steven Reed），KIT 投資公司。

Hey, guys. Great progress. A couple questions. On the full four knots, are you going to be moved to studying that in pigs first or what’s kind of your next steps?

嘿，大家好。很大的進步。幾個問題。在完整的四個結中，您是否會先在豬身上進行研究，或者您的下一步是什麼？

Thanks for the question, Steve. Always great to catch up with you. So as we look to gemcitabine, one of the reasons we chose gemcitabine initially in the Phase 3 trial is it’s so well characterized and we did have a lot of early experience with it.

謝謝你的提問，史蒂夫。很高興能和你見面。因此，當我們考慮吉西他濱時，我們最初在 3 期試驗中選擇吉西他濱的原因之一是它的特性非常明確，而且我們確實對它有很多早期經驗。

As we look to other drugs, we will perform animal experience to ensure we’re not causing any major detrimental vascular damage. And then as we discussed IITs and even registry patients with physicians, as we look to other agents, we will make sure we perform preclinical studies in conjunction with those physicians or on our own to ensure as we move into humans, that we don’t have issues. So short answer to your question, yes. And we have begun exploring what other drugs do to the vessel wall and like gemcitabine so far, it looks like we don’t have any issues.

當我們研究其他藥物時，我們將進行動物實驗，以確保不會造成任何重大的有害血管損傷。然後，當我們與醫生討論 IIT 甚至註冊患者時，當我們尋找其他藥物時，我們將確保與這些醫生一起或自行進行臨床前研究，以確保在應用於人體時不會出現問題。所以對於您的問題，簡短的回答是：是的。我們已經開始探索其他藥物對血管壁的影響，例如吉西他濱，到目前為止，看起來我們沒有遇到任何問題。

Okay. So do you think a few of those studies you’ll be sharing with us in the next quarters on which preclinical studies those might be, where you have the most interest?

好的。那麼，您認為您將在接下來的幾季與我們分享哪些臨床前研究，您最感興趣的是哪些研究？

Yeah, we haven’t disclosed publicly where we are in the process of preclinical studies and which drugs. But for sure, as we move into patients being treated, especially under the guise of launching the registry, either during that time or events of that, if we have publishable data, we’ll do so.

是的，我們還沒有公開披露臨床前研究的進展以及研究哪些藥物。但可以肯定的是，當我們開始治療患者時，特別是在啟動登記的幌子下，無論是在那段時間還是在那段事件中，如果我們有可發布的數據，我們就會這樣做。

Okay. It’s great to see your in house sales team coming together. I was curious if you could give us an update if you’re simultaneously still working on some partnerships, distributors. I saw in March and June that you might have issued some restricted stock in consideration for commercial contracts. Really, any color around that would be helpful as well.

好的。很高興看到您的內部銷售團隊團結一致。我很好奇，如果您同時仍在致力於一些合作夥伴關係和經銷商，您能否向我們提供最新消息？我在三月和六月看到，您可能已經發行了一些限制性股票以換取商業合約。確實，周圍的任何顏色也會有幫助。

Yeah. Thanks for the question, Steven. So to clarify, we issued some stock options or research stock to our contract manufacturer, Medical Murray, in conjunction with a ramping production to get us to where we are today and then take us to the next level in terms of providing enough catheters for sales to treat patients. So that’s on the partnership side, on the manufacturing side, that’s complete and underway. As far as the distribution side, we’ve been talking to several potential strategic distribution partners. And what I’ve said publicly previously is we’ll do the math around what’s makes most economic sense.

是的。謝謝你的提問，史蒂文。因此需要澄清的是，我們向我們的合約製造商 Medical Murray 發行了一些股票選擇權或研究股票，同時提高產量，以使我們達到今天的水平，然後在提供足夠的導管用於治療患者方面將我們提升到一個新的水平。因此，在合作方面和製造方面，這項工作已經完成並正在進行中。就分銷方面而言，我們一直在與幾個潛在的策略性分銷合作夥伴進行洽談。我之前公開說過，我們會計算出什麼是最經濟合理的。

Given what we’ve achieved so far without any sales or marketing in house team, besides myself and a couple of my team members for the most part, it’s been prudent financially to make sure we capture all the revenue versus revenue share for this initial market entry.

考慮到我們迄今為止所取得的成就，除了我和我的幾個團隊成員之外，沒有任何內部銷售或行銷團隊，從財務角度來看，確保我們獲得首次進入市場的所有收入而不是收入份額是明智的。

We’ve done the math on it, keeping our burn relatively the same with the addition of Phil Stocton, and he’s pulling in a handful of sales reps over the next several months or quarters. We’ll make a decision down the road as we want to scale or need to scale based on usage in which tumor types and how far we can scale. If we should grow the sales force even further down the road next year, or actually strike a partnership and leverage the distribution channel of a large medical device company. Those discussions, I said publicly are ongoing, But for the short term, in the meantime, we do plan on driving with our in house team to capture the best value for our shareholders.

我們已經對此進行了計算，在加入 Phil Stocton 後，我們的資金消耗將保持相對不變，而且他將在接下來的幾個月或幾個季度內吸引一批銷售代表。我們將根據腫瘤類型的用途以及我們可以擴展的程度來做出決定，因為我們想要擴展或需要擴展。我們是否應該在明年進一步擴大銷售隊伍，或實際上建立合作夥伴關係並利用大型醫療器材公司的分銷管道。我公開表示，這些討論仍在進行中，但就短期而言，同時，我們確實計劃與我們的內部團隊一起努力，為股東創造最大價值。

Thanks, Shaun. That’s all I have.

謝謝，肖恩。這就是我所擁有的一切。

Thanks for the question, Steven.

謝謝你的提問，史蒂文。

(Operator Instructions)

（操作員指示）

It appears that there are no further questions today. I would now like to pass the floor over to Shaun Bagai for closing comments.

看來今天沒有其他問題了。現在我想請 Shaun Bagai 作最後發言。

Thank you for the opportunity and for those dialing in and listening in. Thank you. And I appreciate the questions from those who called in as well. I’m very happy and thrilled with the results we’ve had for our second quarter of this year, both in terms of the commercial success to date without in house sales and marketing team, and then the progress we’re making with the additional hire Phil Stocton as he built out his team. Also timing was excellent and a great happenstance to have the DMC have the ability to review the second interim analysis.

感謝您提供的機會，也感謝各位撥入電話並收聽。謝謝。我也非常感謝那些打電話提問的人。我對今年第二季取得的成績感到非常高興和激動，無論是在沒有內部銷售和行銷團隊的情況下迄今為止取得的商業成功，還是在聘請 Phil Stocton 組建團隊後我們取得的進展。時機非常好，而且 DMC 還有機會審查第二次中期分析，這真是一個偉大的巧合。

And we’re proud and happy to see the continuation, which gives us confidence that we should be hopefully moving towards a successful clinical trial in a Phase 3 manner and locally advanced pancreatic cancer. I’m also happy with the prudent decision here to protect the integrity of the trial. That’s we have the best chance of success with a potential NDA application down the road. Thank you again for everyone chiming in and look forward to following up with individuals down the road.

我們很自豪和高興地看到研究繼續進行，這給了我們信心，希望我們能夠以第三階段的方式成功進行臨床試驗，並治療局部晚期胰腺癌。我也很高興看到這裡所做的謹慎決定，以保護審判的完整性。這意味著我們將來在潛在的 NDA 申請中獲得成功的可能性最大。再次感謝大家的參與，並期待日後與大家跟進。

This concludes today’s teleconference. You may disconnect your lines at this time. Thank you for your participation.

今天的電話會議到此結束。現在您可以斷開線路。感謝您的參與。