Inovio Pharmaceuticals Inc (INO) 2025 Q2 法說會逐字稿

Good afternoon, ladies and gentlemen, and welcome to the Inovio Second Quarter 2025 Financial Results Conference Call. (Operator Instructions) This call is being recorded on Tuesday, August 12, 2025.

女士們、先生們，下午好，歡迎參加 Inovio 2025 年第二季財務業績電話會議。（操作員指示）此通話於 2025 年 8 月 12 日星期二錄製。

I would now like to turn the conference over to Jennie Willson. Please go ahead.

現在我想將會議交給珍妮威爾森 (Jennie Willson)。請繼續。

Good afternoon, and thank you for joining the Inovio Second Quarter 2025 Financial Results Conference Call.

下午好，感謝您參加 Inovio 2025 年第二季財務業績電話會議。

Joining me on today's call are Dr. Jacqui Shea, President and Chief Executive Officer; Dr. Mike Sumner, Chief Medical Officer; Peter Kies, Chief Financial Officer; and Steve Egge, Chief Commercial Officer.

參加今天電話會議的還有總裁兼執行長 Jacqui Shea 博士、首席醫療官 Mike Sumner 博士、財務長 Peter Kies 和首席商務官 Steve Egge。

Today's call will review our corporate and financial information for the quarter ended June 30, 2025, as well as provide a general business update. Following prepared remarks, we will conduct a question-and-answer session.

今天的電話會議將回顧我們截至 2025 年 6 月 30 日的季度的公司和財務信息，並提供一般業務更新。在準備好的發言之後，我們將進行問答環節。

During the call, we will be making forward-looking statements regarding future events and the future performance of the company. These events relate to our business plans to develop Inovio's DNA medicines platform, which include clinical and regulatory developments and timing of clinical data readouts and planned regulatory submissions along with capital resources and strategic matters.

在電話會議中，我們將對未來事件和公司未來表現做出前瞻性陳述。這些事件與我們開發 Inovio 的 DNA 藥物平台的業務計劃有關，其中包括臨床和監管發展、臨床數據讀數的時間和計劃的監管提交以及資本資源和戰略事項。

All of these statements are based on the beliefs and expectations of management as of today. Actual events or results could differ materially. We refer you to the documents we file from time to time with the SEC which under the Risk Factors heading identify important factors that could cause actual results to differ materially from those expressed by the company verbally as well as statements made within this afternoon's press release.

所有這些聲明都是基於管理層今天的信念和期望。實際事件或結果可能有重大差異。我們請您參閱我們不時向美國證券交易委員會提交的文件，這些文件在「風險因素」標題下列出了可能導致實際結果與公司口頭表達的結果以及今天下午的新聞稿中所作的聲明存在重大差異的重要因素。

This call is being webcast live, and a link can be found on our website, ir.inovio.com, and a replay will be made available shortly after this call is concluded.

本次電話會議將進行網路直播，連結可在我們的網站 ir.inovio.com 上找到，會議結束後不久將提供重播。

I will now turn the call over to Inovio's President and CEO, Dr. Jacqui Shea.

現在我將電話轉給 Inovio 總裁兼執行長 Jacqui Shea 博士。

Good afternoon, and thank you for joining today's call. I'd like to start today by highlighting the important progress we've made so far this year as we work to achieve our key strategic priorities. Most importantly, I'm very pleased to report that we remain on track to submit our BLA for INO-3107 in the second half of this year, thanks to several key accomplishments.

下午好，感謝您參加今天的電話會議。今天，我想先強調我們今年在努力實現關鍵策略重點方面所取得的重要進展。最重要的是，我很高興地報告，由於取得了幾項關鍵成就，我們仍有望在今年下半年提交 INO-3107 的 BLA。

We have completed the design verification or DV testing of our CELLECTRA 5PSP device, which allows us to move forward with the next key regulatory milestones for this program. Utilizing the breakthrough therapy designation awarded by the FDA to 3107 we have also requested rolling submission of our BLA. Our goal is to complete the submission and receive file acceptance by year-end. We plan to request a priority review of our BLA, which, if accepted, would provide a six-month review of the file, potentially providing for a PDUFA date around the middle of 2026.

我們已經完成了 CELLECTRA 5PSP 設備的設計驗證或 DV 測試，這使我們能夠推進該計劃的下一個關鍵監管里程碑。利用 FDA 授予 3107 的突破性療法認定，我們也要求滾動提交 BLA。我們的目標是在年底前完成提交並獲得文件接受。我們計劃請求對我們的 BLA 進行優先審查，如果被接受，將對文件進行為期六個月的審查，並可能在 2026 年中期確定 PDUFA 日期。

I'm also pleased to report that in addition to the publication of our Phase 1/2 clinical data in Nature Communications, earlier this year, data from our retrospective study on the long-term clinical effect of 3107 have been published in the Laryngoscope, the leading journal for physicians who treat RRP. These data are an integral part of our BLA submission package and core to our belief that 3107 could become the preferred product for patients and providers alike. Mike and Steve will provide further details shortly.

我還很高興地報告，除了今年早些時候在《自然通訊》上發表我們的 1/2 期臨床數據外，我們對 3107 長期臨床效果的回顧性研究數據已在治療 RRP 的醫生的領先雜誌《喉鏡》上發表。這些數據是我們 BLA 提交包中不可或缺的一部分，也是我們相信 3107 可能成為患者和提供者首選產品的核心。麥克和史蒂夫將很快提供更多詳細資訊。

While we continue to drive progress on the regulatory front, we have also continued working to advance our commercial plans ensuring that we are prepared for a swift and efficient launch should 3107 be approved. That includes engaging in further market research and continuing to refine our go-to-market plans.

在我們繼續推動監管方面取得進展的同時，我們也繼續努力推進我們的商業計劃，確保一旦 3107 獲得批准，我們就能迅速有效地啟動。這包括進行進一步的市場研究並繼續改善我們的市場進入計劃。

And finally, while we are primarily focused on the BLA submission for our lead asset 3107, we are excited about the potential of our broader pipeline. Most recently, we've had opportunities to highlight the broad therapeutic potential of our next-generation DNA medicine technology, including sharing the top line data from a Phase 1/2 trial of our DNA-encoded monoclonal antibody or dMAb technology, and a preprint on Research Square and featuring dMAbs and our DNA-encoded protein replacement or DPROT technology and a presentation at the Orphan Drug Summit in Boston this past July.

最後，雖然我們主要關注主要資產 3107 的 BLA 提交，但我們對更廣泛的管道潛力感到興奮。最近，我們有機會強調我們下一代 DNA 藥物技術的廣泛治療潛力，包括分享我們 DNA 編碼單株抗體或 dMAb 技術 1/2 期試驗的頂線數據、在 Research Square 上發表預印本並介紹 dMAbs 和我們的 DNA 編碼蛋白質替代或 DPROT 技術，以及在今年 7 月於波士頓舉行的孤兒藥峰會上進行演示。

We believe there are multiple diseases or medical conditions that our DPROT platform could successfully target, and we are actively seeking partnerships to advance this technology into the clinic. I look forward to sharing more on our progress there in the coming months.

我們相信我們的 DPROT 平台可以成功針對多種疾病或醫療狀況，我們正在積極尋求合作夥伴關係以將這項技術推向臨床。我期待在未來幾個月分享更多我們在那裡取得的進展。

With that, I'll hand it over to Mike for an update on our progress with 3107.

說完這些，我將把麥克風交給 Mike，讓他報告 3107 的最新進展。

Thanks, Jacqui. As Jacqui highlighted, we have made significant progress so far this year towards our primary goal, which is to submit our BLA for INO-3107 in the second half of 2025. With DV testing for the CELLECTRA 5PSP device complete and non-device-related modules of the BLA ready for submission, we have moved forward with the next phase of our regulatory plans, requesting rolling submission of our BLA from the FDA in July. Rolling submission is one of the options available to candidates like 3107 that have been granted breakthrough therapy designation. We aim to complete our BLA submission over the next several months and request a priority review. If granted, this would allow for a six-month review period leading to a potential PDUFA date in the middle of 2026.

謝謝，杰奎。正如 Jacqui 所強調的，今年到目前為止，我們在實現主要目標方面已經取得了重大進展，即在 2025 年下半年提交 INO-3107 的 BLA。隨著 CELLECTRA 5PSP 設備的 DV 測試完成以及 BLA 的非設備相關模組準備提交，我們已經推進了監管計劃的下一階段，請求 FDA 在 7 月滾動提交我們的 BLA。滾動提交是 3107 等獲得突破性療法認定的候選藥物可用的選項之一。我們的目標是在接下來的幾個月內完成 BLA 提交並要求優先審查。如果獲得批准，這將允許六個月的審查期，最終確定 PDUFA 日期為 2026 年中期。

We are now focused on finalizing the device-related sections of the BLA and updating our active IND so that we can commence enrollment for our placebo-controlled randomized confirmatory trial, which will include 100 RRP patients and be conducted at approximately 20 sites across the United States. Amidst our focus on preparing for our BLA submission, I'm also pleased to report that the FDA inspection of Inovio as clinical sponsor of the Phase 1/2 trial was successfully completed. This is an important step in the regulatory process that's designed to assess compliance with FDA regulations for the conduct of clinical trials.

我們現在專注於完成 BLA 中與設備相關的部分並更新我們的活躍 IND，以便我們可以開始招募安慰劑對照的隨機確認試驗，該試驗將包括 100 名 RRP 患者並在美國約 20 個地點進行。在我們專注於準備 BLA 提交的同時，我也很高興地報告，FDA 對 Inovio 作為 1/2 期試驗臨床贊助商的檢查已成功完成。這是監管流程中的重要一步，旨在評估臨床試驗是否符合 FDA 規定。

And finally, we've continued to add to the body of research, demonstrating the transformational potential of 3107. In addition to the immunology and clinical data from our Phase 1/2 trial, published in Nature Communications earlier this year. Data from our retrospective study, RRP-002, investigating the long-term clinical efficacy in patients treated with 3107 have just been published in a peer-reviewed journal, The Laryngoscope, which targets the key physicians who treat RRP.

最後，我們持續擴大研究範圍，展示 3107 的轉型潛力。除了我們今年稍早在《自然通訊》上發表的 1/2 期試驗的免疫學和臨床數據。我們的回顧性研究 RRP-002 研究了接受 3107 治療的患者的長期臨床療效，其數據剛剛發表在同行評審期刊《喉鏡》上，該期刊針對治療 RRP 的主要醫生。

As a reminder, we conducted this separate retrospective trial to collect long-term efficacy data on 28 of the original 32 patients with a median follow-up of 2.8 years. We first announced the data in December of last year and later presented it at the Combined Otolaryngology Spring Meeting, otherwise known as COSM. It demonstrates that 3107 provided significant clinical benefit to RRP patients as measured by reduction in surgery. That continued to improve in almost all patients through year 2 and into year 3 following initial treatment. More specifically, in the first year, 72% of patients saw a 50% to 100% reduction in the number of surgeries after starting treatment with 3107.

提醒一下，我們進行了這項單獨的回顧性試驗，以收集最初 32 名患者中的 28 名患者的長期療效數據，中位追蹤期為 2.8 年。我們於去年 12 月首次公佈了這些數據，隨後在聯合耳鼻喉科春季會議（也稱為 COSM）上進行了展示。這表明 3107 為 RRP 患者提供了顯著的臨床益處，以減少手術來衡量。在初次治療後的第 2 年和第 3 年，幾乎所有患者的病情都得到了持續改善。更具體地說，在第一年，72% 的患者在開始使用 3107 治療後手術次數減少了 50% 至 100%。

With no additional dosing, this number increased to 86%. In the second 12-month period or year 2, with half of the patients requiring no surgeries at all, an increase from 28% in year 1. Focusing on the mean number of surgeries per year. You can see here that they continue to drop from 4.1 surgeries in the year prior to receiving 3107 to 1.7 for year 1 to 0.9 for year 2. Although we only have partial data for year 3, the improvement seems to be holding steady and we believe this presents an opportunity to consider a longer-term treatment strategy that leverages one of the core strengths of our DNA medicine platform, which is the ability to administer additional doses to continue to drive and amplify strong T cell-based immune responses without having to worry about the impact of an anti-vector response.

在沒有額外劑量的情況下，這個數字增加到了 86%。在第二個 12 個月或第二年，有一半的患者根本不需要手術，比第一年的 28% 增加。關注每年的平均手術次數。您可以在這裡看到，他們從接受 3107 的前一年的 4.1 次手術下降到第一年的 1.7 次，再下降到第二年的 0.9 次。雖然我們只有第 3 年的部分數據，但這種改善似乎保持穩定，我們相信這為我們考慮長期治療策略提供了機會，該策略利用我們的 DNA 藥物平台的核心優勢之一，即能夠施用額外的劑量以繼續驅動和放大強大的基於 T 細胞的免疫反應，而不必擔心抗載體反應的影響。

With that approach, we could potentially maintain complete and partial responses or extend clinical improvement, including the potential for non-responders to mount a clinical response. Collectively, we believe this research illustrates some of the foundational strengths of our RRP program, strengths that potentially position 3107 as a new standard of care for RRP and the preferred treatment by patients and their health care providers.

透過這種方法，我們可以潛在地維持完全和部分反應或延長臨床改善，包括無反應者產生臨床反應的可能性。總的來說，我們相信這項研究說明了我們的 RRP 計劃的一些基礎優勢，這些優勢可能使 3107 成為 RRP 護理的新標準以及患者及其醫療保健提供者的首選治療方法。

First, there is a significant unmet need for a therapeutic option that reduces the number of surgeries patients face to control this debilitating rare disease. Aside from posing risk for permanent vocal cord damage and burdening patients with emotional and financial costs, these surgeries don't address the underlying disease, and that's where the potential of 3107 comes in. Our treatment is designed to reduce the need for surgery for a broad range of patients by teaching their immune system to fight the human papillomavirus causing their disease.

首先，人們迫切需要一種治療方法來減少患者為控制這種使人衰弱的罕見疾病而面臨的手術次數。除了造成永久性聲帶損傷的風險以及給患者帶來情感和經濟負擔之外，這些手術並不能解決潛在的疾病，而這正是 3107 的潛力所在。我們的治療旨在透過教導患者的免疫系統對抗導致其疾病的人類乳突病毒來減少廣大患者的手術需求。

In the Nature Communications paper, we described our proposed mechanism of action, showing that 3107 was able to elicit an antigen-specific T cell response against both HPV6 and HPV11 proteins. The two strains known to cause the vast majority of RRP cases. That T cell response correlated to the reduction in surgery we observed in the trial. Looking at our RRP-001 and 002 clinical trials together, we have demonstrated that treatment with 3107 resulted in long-term surgery reduction for patients indicating that 3107, if approved, could be an effective treatment option for RRP with the potential to change the trajectory of patients' disease.

在《自然通訊》論文中，我們描述了我們提出的作用機制，顯示 3107 能夠引發針對 HPV6 和 HPV11 蛋白的抗原特異性 T 細胞反應。已知這兩種菌株是導致絕大多數 RRP 病例的原因。T 細胞反應與我們在試驗中觀察到的手術減少有關。綜合考慮我們的 RRP-001 和 002 臨床試驗，我們證明使用 3107 治療可以減少患者的長期手術量，這表明 3107（如果獲得批准）可能成為 RRP 的有效治療選擇，並有可能改變患者的疾病軌跡。

And finally, we are working to initiate the confirmatory trial, which is a randomized placebo-controlled trial that takes into account both FDA feedback and patients focus on reduction in surgery and is designed for patients who have had two or more surgeries in the year prior to treatment initiation. The design of the trial also aligns with feedback from European regulators which is important for future development plans.

最後，我們正在努力啟動確認性試驗，這是一項隨機安慰劑對照試驗，它既考慮了 FDA 的回饋，也考慮了患者對減少手術的關注，並且是為在開始治療前一年內接受過兩次或兩次以上手術的患者設計的。試驗的設計也符合歐洲監管機構的回饋，這對未來的發展計畫很重要。

With that, I'll turn it over to our Chief Commercial Officer, Steve Egge, for some additional commercial insights. Steve?

接下來，我將把問題交給我們的首席商務官史蒂夫·埃格 (Steve Egge)，以徵求一些額外的商業見解。史蒂夫？

Thanks, Mike. I'd like to take a few moments to highlight how we're leveraging and building on those foundational strengths that Mike just described in our commercial strategy and why they're central to our belief that 3107 will become the preferred product for patients and providers.

謝謝，麥克。我想花點時間強調我們如何利用和建立 Mike 剛才在我們的商業策略中描述的那些基礎優勢，以及為什麼它們對於我們相信 3107 將成為患者和提供者的首選產品至關重要。

Let's start with the patients and the market opportunity. In the US, the most widely cited US epidemiology data published in 1995 estimated there were 14,000 active adult and juvenile RRP cases and about 1.8 per 100,000 new cases of RRP in adults each year. However, research and our own claims data analysis indicates that these estimates are likely underrepresenting the prevalence of the disease. Because HPV vaccination rates are plateauing and because the majority of the adult population remains unvaccinated, the risk of our RRP remains steady.

讓我們從患者和市場機會開始。在美國，1995 年發表的被廣泛引用的美國流行病學數據估計，每年有 14,000 例活躍的成人和青少年 RRP 病例，每 100,000 例新發成人 RRP 病例中約有 1.8 例。然而，研究和我們自己的索賠數據分析表明，這些估計值可能低估了疾病的流行程度。由於 HPV 疫苗接種率趨於穩定，且大多數成年人口仍未接種疫苗，因此我們的 RRP 風險保持穩定。

In fact, HPV experts believe the HPV vaccine is unlikely to have a significant impact on our RRP prevalence in adults for at least a generation. As Mike noted earlier, 3107 was designed with the understanding that every surgery matters because every surgery carries both a risk and a cost to the patient. We believe 3107 has the potential to address a significant unmet need by targeting the underlying cause of RRP to reduce the number of surgeries these patients face.

事實上，HPV 專家認為 HPV 疫苗至少在一代人的時間內不太可能對我們成年人的 RRP 盛行率產生重大影響。正如 Mike 之前提到的，3107 的設計理念是每次手術都很重要，因為每次手術都會為患者帶來風險和成本。我們相信 3107 有潛力透過針對 RRP 的根本原因來滿足尚未滿足的重大需求，從而減少這些患者面臨的手術次數。

We also see potential to provide continuation of therapy with 3107, meaning additional dosing over time to maintain or extend patient outcomes, which is important in a chronic lifelong disease. So not only is there significant market opportunity here, our market research continues to tell us that patients and providers find the combination of efficacy, tolerability and simplicity that 3107 offers very compelling.

我們也看到了 3107 提供持續治療的潛力，這意味著隨著時間的推移增加劑量以維持或延長患者的治療效果，這對於慢性終身疾病非常重要。因此，這裡不僅存在巨大的市場機會，我們的市場研究也不斷告訴我們，患者和提供者發現 3107 提供的功效、耐受性和簡單性的結合非常引人注目。

With respect to efficacy, the vast majority of patients saw a significant benefit from 3107 and many of them -- for many of them, that benefit continued to improve over time. The physicians we spoke to were most interested in the overall response rate, 72% in year 1 would increase to 86% in year 2 and they noted, while the complete response rate is good, a 50% to 100% reduction in surgeries and 8 out of 10 patients is most compelling. Similarly, when laryngologists look at the tolerability data, they see a generally well-tolerated treatment that would have a limited impact on patients return to daily life, which is important when a patient is receiving four doses over a relatively short period of time.

就療效而言，絕大多數患者從 3107 中獲得了顯著益處，對於其中許多患者而言，這種益處隨著時間的推移而持續改善。我們訪談的醫生對整體反應率最感興趣，第一年的 72% 將在第二年上升到 86%，他們指出，雖然完全反應率不錯，但手術量減少 50% 到 100% 以及 10 名患者中有 8 名能夠接受手術是最令人信服的。同樣，當喉科醫生查看耐受性數據時，他們發現這種治療方法總體上耐受性良好，對患者恢復日常生活的影響有限，這對於患者在相對較短的時間內接受四次劑量治療時非常重要。

And finally, with respect to the treatment regimen itself, 3107 could be administered in the physician's office. There's no need to refer patients out to an infusion center, so the physician maintains control. The device is also simple to use. And with 3107, there is no requirement for scoping or surgeries during the treatment window. This is important because, again, every single surgery carries both a risk and a cost to the patient, these market insights have been critical as we continue to advance our launch preparations. Key progress so far includes building our distribution and channel strategy and identifying partners. We signed a contract with a 3PL provider and are in the process of negotiating contracts with our specialty pharmacy, specialty distributor and patient hub partners.

最後，就治療方案本身而言，3107 可以在醫生辦公室進行管理。無需將患者轉診至輸液中心，因此醫生可以保持控制權。該設備使用起來也很簡單。而使用 3107，治療期間無需進行檢查或手術。這很重要，因為每一次手術都會給患者帶來風險和成本，這些市場洞察對於我們繼續推進發布準備至關重要。迄今為止的主要進展包括建立我們的分銷和通路策略以及確定合作夥伴。我們與一家 3PL 供應商簽訂了合同，並且正在與我們的專業藥房、專業分銷商和患者中心合作夥伴協商合約。

We have also conducted research with payers and developed our initial pricing strategy as well as developed our physician and patient targeting segmentation and product positioning work supporting positive differentiation. I look forward to providing more updates on our progress next quarter as we finalize our go-to-market model, and plan to further build-out of the commercial organization.

我們還與付款人進行了研究，制定了初步的定價策略，並制定了針對醫生和患者的細分和支持積極差異化的產品定位工作。我期待在下個季度提供更多有關我們進展的最新信息，因為我們將最終確定我們的市場進入模式，併計劃進一步擴大商業組織。

With that, I'll turn it over to Peter for a financial update.

說完這些，我會把財務更新交給彼得。

Thanks, Steve. Today, I'd like to provide an overview of Inovio's financial results for the second quarter 2025 and provide a financial snapshot of the year so far.

謝謝，史蒂夫。今天，我想概述 Inovio 2025 年第二季的財務業績，並提供今年迄今的財務概況。

Our goal is to ensure that Inovio's resources are strategically aligned to advance our lead candidate 3107. I am pleased to report that in the second quarter, we've continued to work efficiently and with fiscal responsibility to support the important progress my colleagues have highlighted today. As you can see here, we've been able to significantly reduce our operating expenses over the past year. Our operating expenses dropped from $33.3 million in the second quarter of 2024 to $23.1 million in the second quarter of 2025, a 31% decrease. When you look at the first six months of 2025, we've reduced operating expenses by 26% compared to the same period last year.

我們的目標是確保 Inovio 的資源在策略上保持一致，以推進我們的主要候選藥物 3107。我很高興地報告，在第二季度，我們繼續高效工作並承擔財政責任，以支持我的同事今天強調的重要進展。正如您所看到的，我們在過去一年中已經大幅降低了營運費用。我們的營運費用從 2024 年第二季的 3,330 萬美元下降到 2025 年第二季的 2,310 萬美元，下降了 31%。回顧 2025 年上半年，我們的營運費用與去年同期相比減少了 26%。

Again, this is due to a strategic effort to manage our resources with the efficiency and precision needed to support progress for the 3107 program. Inovio's net loss for the second quarter of 2025 dropped 27% to $23.5 million from a net loss of $32.2 million in the second quarter of 2024. On a per share basis, both basic and dilutive, the net loss for the second quarter of 2025 dropped 49% to $0.61 per share from $1.19 per share for the second quarter of 2024. You can see similar reductions in our net loss for the entire six months of 2025 versus 2024, as we continue to conserve our resources to support the 3107 program.

再一次，這是因為我們做出了策略性努力，以高效和精確的方式管理我們的資源，從而支持 3107 計劃的進展。Inovio 2025 年第二季的淨虧損較 2024 年第二季的 3,220 萬美元下降 27% 至 2,350 萬美元。以基本和稀釋每股計算，2025 年第二季的淨虧損從 2024 年第二季的每股 1.19 美元下降 49% 至每股 0.61 美元。您可以看到，由於我們繼續節省資源來支持 3107 計劃，我們 2025 年整個六個月的淨虧損與 2024 年相比也有類似的減少。

We finished the second quarter of 2025 with $47.5 million in cash, cash equivalents and short-term investments compared to $94.1 million as of December 31, 2024. This excludes efforts to strengthen our balance sheet with an underwritten public offering of common stock and warrants in July 2025. Net proceeds from the offering, after deducting underwriter discounts, commissions and operating expenses, were approximately $22.5 million. Including the funds from the public offering, we estimate our cash runway to take us into the second quarter of 2026. This projection includes an operational net cash burn estimate of approximately $22 million for the third quarter of 2025.

截至 2025 年第二季度，我們的現金、現金等價物和短期投資為 4,750 萬美元，而截至 2024 年 12 月 31 日為 9,410 萬美元。這還不包括 2025 年 7 月透過承銷公開發行普通股和認股權證來加強資產負債表的努力。扣除承銷商折扣、佣金和營運費用後，此次發行的淨收益約為 2,250 萬美元。包括公開發行的資金在內，我們估計我們的現金流將維持到 2026 年第二季。該預測包括 2025 年第三季約 2,200 萬美元的營運淨現金消耗估計。

These cash runway projections do not include any further capital raising activities that we may undertake. As a reminder, you can find our full financial statements in this afternoon's press release as well as in our quarterly report, Form 10-Q filed today with the SEC.

這些現金流預測不包括我們可能進行的任何進一步的融資活動。提醒一下，您可以在今天下午的新聞稿以及我們今天向美國證券交易委員會提交的季度報告 10-Q 表中找到我們的完整財務報表。

And with that, I'll turn it back over to Jacqui.

說完這些，我將把發言權交還給 Jacqui。

Thanks, Peter. While we spend most of today's call talking about our focus on 3107, we are very excited about the potential of our overall pipeline that continues to make progress through the power of our partnerships. Of particular note, the ongoing exciting research at the Basser Center at the University of Pennsylvania on the potential for INO-5401 to prevent cancer in people with BRCA1 and BRCA2 mutations has recently been highlighted in the news. While our partner ApolloBio in China have continued to advance the Phase 3 development of VGX-3100 for HPV-16 and 18 related cervical HSIL for that marketplace.

謝謝，彼得。雖然我們今天的大部分時間都在討論對 3107 的關注，但我們對我們的整體管道潛力感到非常興奮，該管道將繼續透過我們合作夥伴的力量取得進展。特別值得注意的是，賓州大學巴瑟中心正在進行的關於 INO-5401 對 BRCA1 和 BRCA2 突變患者預防癌症的潛力的激動人心的研究最近成為新聞焦點。而我們在中國的合作夥伴 ApolloBio 則持續推動針對該市場 HPV-16 和 18 相關子宮頸 HSIL 的 VGX-3100 的 3 期開發。

And as I mentioned earlier, we and our partners at the Wistar Institute and University of Pennsylvania announced top line clinical data for our promising next-gen dMAb programs. It's worth noting that our BLA for 3107 will be the first filed for a DNA medicine in the United States and if approved, could open the door for future partnerships and development opportunities across our pipeline, both in the US and globally.

正如我之前提到的，我們和我們在威斯塔研究所和賓州大學的合作夥伴公佈了我們有前景的下一代 dMAb 計畫的頂級臨床數據。值得注意的是，我們針對 3107 提交的 BLA 將是美國首個 DNA 藥物申請，如果獲得批准，將為我們在美國乃至全球範圍內的未來合作和發展機會打開大門。

I'd now like to open up the call to answer any questions you might have. Operator?

現在我想開始回答你們可能提出的任何問題。操作員？

(Operator Instructions) Your first question is from Ted Tenthoff from Piper Sandler.

（操作員指示）您的第一個問題來自 Piper Sandler 的 Ted Tenthoff。

Great. Thank you very much, and congrats on the update and looking forward to continued progress, not just with the lead asset but also the pipeline initially outlined. I'm wondering, as you start to wrap up the filing, are you anticipating having an advisory committee meeting -- and what kind of prep work are you doing for a potential advisory -- AdCom.

偉大的。非常感謝，並祝賀更新，並期待繼續取得進展，不僅是主要資產，還有最初概述的管道。我想知道，當您開始完成文件提交時，您是否預計會召開諮詢委員會會議 - 以及您為潛在的諮詢委員會做了哪些準備工作 - AdCom。

Ted, it's nice to hear from you. I'll hand over to Mike to talk about the Advisory Committee potential. Mike?

泰德，很高興收到你的來信。我將把時間交給麥克來談論諮詢委員會的潛力。麥克風？

Ted, I mean, at the based on all our interactions with the agency to date, there's certainly been zero indication that this will go to an AdCom. And I think when I look at the sort of overall risk benefit of the data we're presenting, I don't think there will be any requirement for the agency, but obviously, that is their call. But I think the chance of it is relatively low.

泰德，我的意思是，根據我們迄今為止與該機構的所有互動，沒有任何跡象表明這將提交給 AdCom。我認為，當我看到我們所呈現的數據的整體風險效益時，我認為對該機構不會有任何要求，但顯然，這是他們的決定。但我認為這種可能性相對較低。

Got you. And then just in terms of preparation and anything going on, any thoughts in terms of the upcoming regulatory decision for your competitor and how that can either set a stage or potentially prime the pump for your eventual launch hopefully next year.

明白了。然後就準備工作和任何正在進行的事情而言，您對競爭對手即將做出的監管決定有何看法，以及這將如何為您明年的最終發布奠定基礎或做好準備。

Yes. That's a good question. And I think it's important to bear in mind that there are quite a lot of differences between their program and ours. For instance, the way they conducted their initial clinical study was very different, as you know, they conducted scoping and surgeries during their dosing window to maintain minimal residual disease, and we didn't do that. With our focus on every surgery matters for patients, we counted every surgery after day 0 after we started dosing. So real differences in the way the trials were conducted. And I think also real differences as well in the candidates. So we -- our candidate 3107 is based on DNA medicines technology. We don't have a viral vector involved. So very different technologies there. I think their vector, this will be the first time this particular vector has gone to a BLA filing. So differences there.

是的。這是個好問題。我認為重要的是要記住他們的計劃和我們的計劃之間存在著許多差異。例如，他們進行初步臨床研究的方式非常不同，如你所知，他們在給藥窗口期間進行了範圍檢查和手術以維持微小殘留疾病，而我們沒有這樣做。我們關注的是每次手術對患者都很重要，因此我們在開始用藥後的第 0 天之後就對每次手術進行了計數。因此，試驗的實施方式確實存在差異。我認為候選人之間也確實存在差異。因此，我們的候選藥物 3107 是基於 DNA 藥物技術。我們沒有涉及病毒載體。所以那裡的技術非常不同。我認為他們的載體，這將是這個特定載體第一次進入 BLA 備案。所以存在差異。

And then finally, in terms of the confirmatory trial, we're going for a very different confirmatory trial designs. We're going for a placebo-controlled design. We're aiming that trial at patients who've had two or more surgeries in the prior year. And then in contrast, they're going for a single arm design. And I think they're targeting patients who've had three or more surgeries in the prior year. So some real differences between the programs. Mike, Steve, anything you want to add to that?

最後，就確認試驗而言，我們將採用非常不同的確認試驗設計。我們正在進行安慰劑對照設計。我們的試驗對像是過去一年內接受過兩次或兩次以上手術的患者。相比之下，他們選擇採用單臂設計。我認為他們的目標患者是過去一年中接受過三次或三次以上手術的患者。因此這些程序之間確實存在一些差異。麥克、史蒂夫，你們還有什麼要補充的嗎？

No, I think that was comprehensive, Jacqui.

不，我認為這很全面，杰奎。

Your next question is from Jay Olson from Oppenheimer.

您的下一個問題來自奧本海默公司的傑伊·奧爾森 (Jay Olson)。

This is Cheng online for Jay. And congrats on the progress. Just on the DV testing. First, congrats on the completion of that. It just appears to us that maybe the prior guidance was to complete the DV testing in the first half. So we're just wondering if there's like any delays there? Or anything that may have changed regarding your interaction with the regulators? And then we have a follow-up question.

我是傑伊的在線程。並祝賀你的進展。只是進行 DV 測試。首先，恭喜你完成了。在我們看來，也許之前的指導是在上半年完成 DV 測試。所以我們只是想知道那裡是否有任何延誤？或是您與監管機構的互動有變化嗎？然後我們有一個後續問題。

Yes. I think that's a great question. So I think the important thing to bear in mind is our overall timelines. So we remain on track for submitting our BLA in the second half of this year with the goal of file acceptance by year-end. The DV testing is quite a complicated process. We had to work with multiple external vendors, so that wasn't entirely within our control. But I'm pleased to say we're now past that point. We're very much focused on the rolling submission of our BLA, and we're looking forward to those future milestones.

是的。我認為這是一個很好的問題。所以我認為需要牢記的重要一點是我們的整體時間表。因此，我們仍將按計劃在今年下半年提交 BLA，目標是在年底前獲得文件接受。DV測試是一個相當複雜的過程。我們必須與多個外部供應商合作，因此這並不完全在我們的控制範圍內。但我很高興地說，我們現在已經過了那個階段。我們非常關注 BLA 的滾動提交，並期待未來的里程碑。

Got it. And again, congrats on the recent data on the long-term surgery reduction results from RRP-002? And I think there's still pretty good protection at year 3. So just wondering your latest thinking around maybe a redosing strategy for 3107 based on the new data.

知道了。再次恭喜 RRP-002 的長期手術減少結果的最新數據？我認為第三年的保​​護仍然相當好。所以我只是想知道您最近的想法，也許是基於新數據對 3107 進行重新給藥策略。

Mike?

麥克風？

No. So I mean, we mentioned this partly in the call today. I mean we are seeing a sort of stabilization of the clinical effect as we go into the third year. And one of the benefits of our DNA medicine platform. And we -- I think in the last call, we talked about data from our 3100 program that really shows that we can boost that cytotoxic T cell response. So we're definitely going to move forward with a redosing strategy most likely something relatively simple, such as annual dosing so that it's easy for patients and physicians to remember. And then hopefully, that should enhance the clinical effect that we are already very excited about.

不。所以我的意思是，我們在今天的電話會議中提到了這一點。我的意思是，隨著進入第三年，我們看到臨床效果趨於穩定。這是我們 DNA 醫學平台的優勢之一。而且我們——我想在上次電話會議中，我們討論了來自 3100 計劃的數據，這些數據確實表明我們可以增強細胞毒性 T 細胞反應。因此，我們肯定會推進重新給藥策略，很可能是一些相對簡單的策略，例如年度給藥，以便患者和醫生容易記住。然後希望這能增強我們已經非常興奮的臨床效果。

And I think it's important to note that RRP can be a chronic often life-long disease. So I think it's going to be really important that once patients are starting to see this clinical benefit of reduction of surgery that we're able to maintain that benefit and even potentially improve upon it. So I think that's really a key strength of our technology.

我認為值得注意的是，RRP 可能是一種慢性疾病，甚至是終身疾病。因此我認為，一旦患者開始看到減少手術的臨床益處，我們就能夠保持這種益處，甚至可能改善它，這一點非常重要。所以我認為這確實是我們技術的關鍵優勢。

Got it. Just a quick follow-up on that. Is the redosing strategy will be part of the filing or you need some additional data or evidence to show that.

知道了。對此僅做快速跟進。重新給藥策略是否會成為備案的一部分，或者您是否需要一些額外的數據或證據來證明這一點。

We will start discussing that strategy with the agency after we've submitted BLA.

提交 BLA 後，我們將開始與該機構討論該策略。

Your next question is from Sudan Loganathan from Stephens Inc.

您的下一個問題來自 Stephens Inc. 的蘇丹·洛加納坦 (Sudan Loganathan)。

Thank you for the update and congrats on your progress towards the filing for INO-3107. First, I wanted to ask, it's great to see the long-term year 2 data for 3107 get published. Can you remind me what the median number of prior surgeries these patients had that were enrolled in your trial?

感謝您的更新，並祝賀您在申請 INO-3107 方面取得進展。首先，我想問一下，很高興看到 3107 的第二年長期數據得以發布。您能否提醒我參加您試驗的這些患者之前接受過手術的中位數是多少？

Yes, certainly. Sudan. So the patients in the original study had a median of four surgeries. You will see that we've presented mean surgeries in the latest long-term follow-up, and that mean was 4.1. And so when you look at the mean surgeries over time, that dropped to 1.7 in the original Phase 1/2 12-month period and then had a further reduction down to 0.9 in the year 2, the second 12-month period, year 2.

是的，當然。蘇丹。因此，原始研究中的患者平均接受了四次手術。大家會看到，我們公佈了最新長期追蹤中的平均手術次數，當時的平均值是4.1次。因此，如果觀察一段時間內的平均手術次數，就會發現在最初的1/2期（12個月）期間，這一數字下降到了1.7次，然後在第二年，也就是第二個12個月期間，進一步下降到了0.9次。

Got it. Great. I appreciate that. And secondly, with the potential approval by the end of this month for Precigen's asset in RRP, do you anticipate any headwinds to enrolling the 100 patients that you need for the confirmatory trial since there would be potentially approved option on the market? And would you be including patients in your confirmatory trial that were previously dosed on Precigen 2012 asset?

知道了。偉大的。我很感激。其次，由於本月底 Precigen 在 RRP 中的資產可能獲得批准，您是否預計在招募確認試驗所需的 100 名患者時會遇到任何阻力，因為市場上可能存在獲得批准的選擇？您是否會將先前服用過 Precigen 2012 藥物的患者納入您的確認試驗中？

Obviously, I mean, Precigen is not on the market at the moment, so it would be a long time before those patients came into the trial. But we have gone with a strategy that's included sites across the entire United States, even if Precigen are approved, there is usually a lag between this coverage in the people's insurance policy. And also, unfortunately, there will be many patients that still won't have the ability to be covered by medical insurance or be able to afford the out-of-pocket expenses. So I still feel with the prevalence of this disease that we're seeing, there will be a sizable population that will be still accessible for our clinical trial.

顯然，我的意思是，Precigen 目前還沒有上市，所以這些患者還需要很長時間才能參加試驗。但我們採取的策略包括整個美國的站點，即使 Precigen 獲得批准，人們的保險政策中的覆蓋範圍通常也會存在滯後。而且不幸的是，仍有許多患者無法享有醫療保險或無法負擔自付費用。因此，我仍然認為，鑑於這種疾病的流行程度，仍有相當一部分人群可以參加我們的臨床試驗。

I think it's also important to sort of remember that this trial isn't a particularly large trial. We're looking at recruiting about 100 patients across about 20 different clinical sites in the US. So we think it's very achievable even if they are approved.

我認為同樣重要的是要記住，這次試驗並不是一次特別大規模的試驗。我們正在美國大約 20 個不同的臨床地點招募約 100 名患者。因此我們認為即使獲得批准也是可以實現的。

Your next question is from Yi Chen from H.C. Wainwright.

您的下一個問題來自 H.C. Wainwright 的 Yi Chen。

This is Eduardo on for Yi. I guess maybe to get some understanding on how diffuse the physicians are that treat these RRP patients and the commercial infrastructure you guys would need to execute and deploy in order to get a meaningful launch, can you get some color there.

愛德華多替補易建聯上場。我想也許可以了解一下治療這些 RRP 患者的醫生分佈情況，以及為了實現有意義的啟動您們需要執行和部署的商業基礎設施，您能否提供一些詳細資訊。

Steve?

史蒂夫？

Yes, sure. So I believe we've mentioned before, there's 300 to 400 laryngologists that we believe treat the majority of RRP patients out there. It's a mix of these large kinds of academic medical centers, it's probably 65%, 70% of the patients seek care there. And then there's also a large community-based practices, laryngology practices, they're treating these patients. So the numbers overall are small. The patients are treated at a very kind of concentrated fashion. So in terms of the commercial organization required to go after that, it's quite small. We haven't kind of guided to specific numbers there. But when you think about medical science liaisons and access team, sales team, it's a very small kind of cost-efficient commercial organization that's needed to get out and to promote to 300 to 400 laryngologists that live in a very narrow set of locations in the US.

是的，當然。我相信我們之前提到過，我們認為有 300 到 400 名喉科醫生負責治療大多數 RRP 患者。它是這些大型學術醫療中心的混合體，大概有 65% 到 70% 的患者在那裡尋求治療。然後還有大型社區診所、喉科診所，他們正在治療這些病人。所以總體數量很少。病人受到非常集中的治療。因此，就實現這一目標所需的商業組織而言，規模相當小。我們還沒有給出具體的數字。但是，當您考慮醫學科學聯絡和訪問團隊、銷售團隊時，您會發現它是一種規模非常小且具有成本效益的商業組織，需要走出去並向居住在美國非常狹窄地區的 300 到 400 名喉科醫師進行推廣。

Got it. That's really helpful. And then going back to the confirmatory trial design. One of the questions earlier mentioned the fact that you had 4.1 average prior surgeries in the initial trial, and now you're going to drop that down to -- I understand it's around two prior surgeries in prior year. Do you have any data from your initial trial with patients in that subgroup with the fewer surgeries that you can potentially extrapolate to understand the relative impact and reduction of surgeries that you anticipate for the confirmatory trial?

知道了。這真的很有幫助。然後再回到驗證性試驗設計。先前的一個問題提到，在初次試驗中，您平均接受過 4.1 次手術，現在您要將其降至 - 我知道這是前一年大約兩次手術。您是否擁有針對該亞組中手術次數較少的患者進行的初步試驗數據，您可以透過這些數據推斷出您預期的確認性試驗的相對影響和手術減少量？

Yes. So that was the mean number of surgeries. In the original trial, we actually had patients from two up to eight and actually had a very sort of good spread of those surgeries across the entire population. And we saw clinical benefit regardless of how we up the number of surgeries pretreatment. So we're very confident that this will carry forward into our confirmatory trial.

是的。這就是平均手術次數。在最初的試驗中，我們實際上有 2 到 8 名患者，並且實際上在整個人群中很好地傳播了這些手術。無論我們在治療前如何增加手術次數，我們都看到了臨床益處。因此，我們非常有信心這將延續到我們的確認試驗中。

Yes. And I think it's important to note that the reason why we're focused on patients who've had two or more surgeries in the prior year is it's really important to intervene early with RRP. Every surgery comes at a cost and a risk to the patient. So the sooner that we can come in with a nonsurgical therapeutical alternative, the better chance we have of minimizing permanent damage to the vocal cords. So we believe it's very important to start treating these patients as early as possible.

是的。我認為值得注意的是，我們之所以關注那些在過去一年中接受過兩次或兩次以上手術的患者，是因為儘早進行 RRP 介入非常重要。每次手術都會為患者帶來費用和風險。因此，我們越早找到非手術治療方法，就越有機會將聲帶的永久性損傷降到最低。因此我們認為儘早開始治療這些患者非常重要。

Got it. And do you have an estimate in terms of what fraction of current RRP patients meet that clinical criteria?

知道了。您是否估計過目前有多少比例的 RRP 患者符合該臨床標準？

Sure. Yes, this is Steve. So the 14,000 that we referenced, the widely published data, we do think that's an underestimate and we do believe that it's best to try to treat early in the disease to kind of change the trajectory of the disease. Every -- like I said, every surgery matters. The 14,000 published, they did not provide kind of a segment of patients kind of how they break out in terms of surgical burden. But I think what Mike just shared in the Phase 1, Phase 2, we treated patients with a range of surgeries from two to eight with median of four and that may be representative of what the general kind of RRP population looks like. And that's really the kind of prevalent population of patients.

當然。是的，這是史蒂夫。因此，我們引用的 14,000 個廣泛發表的數據，我們確實認為這是一個低估的數字，我們確實相信最好在疾病早期嘗試治療以改變疾病的發展軌跡。每一次——就像我說的，每一次手術都很重要。雖然已經公佈了 14,000 份報告，但他們並沒有提供患者在手術負擔方面的細分情況。但我認為 Mike 在第 1 階段和第 2 階段分享的內容是，我們為患者進行了 2 至 8 次手術，中位數為 4 次，這可能代表了 RRP 族群的一般情況。這確實是普遍的患者群。

But keep in mind, there's also an incident population, newly diagnosed patients every year that also kind of adds to the opportunity. And then as we mentioned earlier, we do expect there'll be an opportunity for continued treatment or additional doses over time, which also expands the commercial opportunity.

但請記住，每年都有發病人群，新診斷的患者也增加了患病機會。正如我們之前提到的，我們確實預計隨著時間的推移會有機會繼續治療或增加劑量，這也擴大了商業機會。

The next question is from Roy Buchanan from Citizens.

下一個問題來自《公民報》的羅伊‧布坎南 (Roy Buchanan)。

Just I wonder if you can provide maybe greater detail on the timelines for the next major events. And more importantly, I guess, with one you're going to announce, I'm thinking it is okay for the rolling submission, the IND revision acceptance, start of the confirmatory trial and BLA acceptance.

我只是想知道您是否可以提供有關接下來重大事件時間表的更多細節。更重要的是，我猜，對於您要宣布的消息，我認為滾動提交、IND 修訂接受、確認試驗的開始和 BLA 接受都是可以的。

Yes. Great questions, Roy. So as we said in the call, we requested rolling submission in July. So we would expect to hear back from the FDA on that rolling submission sometime in August. And then we -- once we hear back, we have modules that are available to submit pretty much immediately. We're working on updating the device sections of our IND to enable -- normal to start within the confirmatory trial. And then we're aiming to complete the submission of all of our modules of the BLA in the second half of this year with sufficient time to allow us to receive acceptance of the file by the FDA by year-end. So that's the overall timeline. We're working as quickly as we can to try and get through those steps.

是的。很好的問題，羅伊。正如我們在電話中所說，我們要求在 7 月滾動提交。因此，我們預計將於 8 月某個時候收到 FDA 關於該滾動提交的回應。然後我們 — — 一旦收到回复，我們就會立即提供可供提交的模組。我們正在更新 IND 的設備部分，以便在確認試驗內正常啟動。然後，我們計劃在今年下半年完成 BLA 所有模組的提交，以便有足夠的時間讓我們在年底前獲得 FDA 對該文件的接受。這就是整體時間表。我們正在盡快努力完成這些步驟。

Okay. Great. We think you'll announce all of those publicly. Is that --

好的。偉大的。我們認為您會公開宣布所有這些。那是嗎--

Yes. We're certainly committed to using our normal channels of communication to provide updates as they occur.

是的。我們當然致力於使用我們的正常溝通管道來提供最新更新。

Okay. Perfect. And then interactions with the FDA since the last report. I guess any impact from some of the volatility around Dr. Prasad on those interactions?

好的。完美的。然後是自上次報告以來與 FDA 的互動。我猜想普拉薩德博士周圍的一些波動會對這些互動產生什麼影響？

Yes. So we're very focused on the things that we can control in our interactions with the FDA, the FDA to date have continued as normal. So we're just very focused on the work that we need to do to get our submission in.

是的。因此，我們非常關注與 FDA 互動中我們可以控制的事情，FDA 迄今為止一直一切正常。因此，我們只是非常專注於我們需要做的工作以提交我們的作品。

Okay. Perfect. And then last couple of ones. I noticed the publication from yesterday that full year 3 results were 6 out of the 28 patients. Are you going to present data from the additional patients completed in year 3, maybe this year?

好的。完美的。然後是最後幾個。我注意到昨天的出版物顯示，第 3 年全年結果是 28 名患者中的 6 名。您是否會提供第三年（也許是今年）完成的額外患者的數據？

And then one for Steve, any change to the pricing outlook from your prior comments?

然後問史蒂夫一個問題，您之前的評論中對定價前景有什麼改變嗎？

Yes. So in terms of the to date. And we obviously have -- because it was a single retrospective look, we have variable length of data depending on when they originally entered into the original study. We have provided some of the data in the press release. But because it becomes -- because there is a different amount of data for different patients, it becomes more difficult to interpret. So I think sort of digging into that third-year data just isn't the best sort of scientific approach, which is why the publication really focused on year 2 where we have a complete set of data, and we can present the complete picture of the original population.

是的。就目前而言。而且我們顯然有——因為這是回顧性觀察，所以我們擁有可變長度的數據，這取決於他們最初進入原始研究的時間。我們在新聞稿中提供了一些數據。但因為不同患者的數據量不同，所以解釋起來變得更加困難。所以我認為深入研究第三年的數據並不是最好的科學方法，這就是為什麼該出版物真正關注的是第二年，因為我們有一整套完整的數據，我們可以呈現原始人口的完整情況。

And then I think your second question -- I think your second question about pricing. So there, we're -- I think we previously guided to Ogsiveo as a potential analog there. And we're not expecting any changes in our ports around pricing. We're expecting rare disease pricing in discussions with payers, they seem to believe that this is appropriate. So really no changes there. Steve, anything you want to add?

然後我認為你的第二個問題——我認為你的第二個問題是關於定價的。所以，我想我們之前已經將 Ogsiveo 引導為那裡的潛在類似物。我們預計我們的港口定價不會有任何變化。我們期待與付款人討論罕見疾病的定價，他們似乎認為這是合適的。所以實際上沒有變化。史蒂夫，你還有什麼要補充的嗎？

No. With respect to price, I mean we've commented there earlier. We did a fair amount of research with payers reviewing the product profile. As Jacqui mentioned, rare disease pricing certainly is appropriate. And then the SpringWorks Therapeutics product, Ogsiveo that's priced at $360,000 a year. That's kind of the range of pricing that we're thinking and that we've shared with payers. Obviously, we can't give more specifics than that, but that's kind of the guidance that we've provided thus far.

不。關於價格，我的意思是我們之前已經評論過了。我們對付款人的產品概況進行了大量的研究。正如 Jacqui 所提到的，罕見疾病的定價當然是合適的。然後是 SpringWorks Therapeutics 產品 Ogsiveo，其每年售價為 36 萬美元。這就是我們正在考慮的並且已經與付款人分享的定價範圍。顯然，我們無法提供更多細節，但這是我們迄今為止提供的指導。

Your next question is from Liang Cheng from Jefferies.

您的下一個問題來自 Jefferies 的 Liang Cheng。

This is Liang Cheng for Roger. So maybe quickly touch on the confirmatory study. So understanding that study has about 20 sites across the United States. And also, you have aligned your study plan with probably UK regulators. So how should we think about your ex-US strategy regarding the confirmatory study?

我是梁成，為羅傑服務。因此也許可以快速觸及驗證性研究。因此，據了解，這項研究在美國各地約有 20 個站點。而且，您已經將您的學習計畫與英國監管機構進行了調整。那麼，我們應該如何看待您針對美國以外的驗證性研究的策略呢？

Yes. So I mean, we've mentioned we were very strategic in making sure that our confirmatory trial in the United States will meet the requirements of the European and UK regulators. So we don't anticipate any difference in terms of how we would structure any study or design it. The two patients was fully in line with what we studied in our Phase 1/2 study. And as we've said, they've requested along with the FDA that have an inclusion criteria of two surgeries, you need to provide placebo-controlled data.

是的。所以我的意思是，我們已經提到過，我們非常有策略地確保我們在美國進行的確認試驗能夠滿足歐洲和英國監管機構的要求。因此，我們預計在研究結構或設計方面不會有任何差異。這兩位患者的情況與我們在第 1/2 階段研究中發現的情況完全一致。正如我們所說，他們與 FDA 一起要求納入兩項手術的標準，您需要提供安慰劑對照數據。

And maybe quickly, are there -- so for ex US, are there any differences in the current practice of treating RRP?

也許很快，那麼對於美國以外的人來說，目前治療 RRP 的做法有什麼不同嗎？

So the -- I mean the one difference that I will note is obviously the majority of European surgeries are actually conducted in the operating theater. And because access to operating the time in Europe can often be a little longer, they tend to actually have a slightly lower number of surgeries which is, again, having the inclusion criteria of just two surgeries was actually important for Europe to make sure that we can include as many European patients in the future onto 3107.

所以——我要指出的一個區別顯然是，歐洲的大多數手術實際上都是在手術室進行的。而且由於歐洲的手術時間通常更長，因此他們實際上進行的手術數量往往會略少，也就是說，僅有兩次手術的納入標準對於歐洲來說實際上很重要，以確保我們將來能夠將盡可能多的歐洲患者納入 3107 項目。

(Operator Instructions) There are no further questions at this time. Please proceed with closing remarks.

（操作員指示）目前沒有其他問題。請繼續致結束語。

Thank you. Before we close today, I'd like to take a moment to note that Inovio will continue the scientific and medical outreach strategy we outlined last quarter with a full schedule of presentation opportunities this fall. We'll be focused on continuing to illustrate the strengths of our RRP program and the potential of 3107 as well as the great potential we see for our next-generation dMAb and DPROT technologies. I would also like to briefly mention the key catalysts we are focused on. First and foremost, submitting our BLA for 3107 on a rolling basis, updating our active IND for our confirmatory trial with our completed device data and continuing to advance our commercial preparations so that we'll be ready to launch 3107 quickly and efficiently, if approved.

謝謝。在今天結束之前，我想花點時間指出，Inovio 將繼續我們上個季度概述的科學和醫學推廣策略，並在今年秋天安排完整的演示機會。我們將專注於繼續展示我們的 RRP 計劃的優勢和 3107 的潛力以及我們所看到的下一代 dMAb 和 DPROT 技術的巨大潛力。我還想簡要地提一下我們關注的關鍵催化劑。首先，也是最重要的，我們將滾動提交 3107 的 BLA，使用已完成的設備數據更新我們用於確認試驗的活躍 IND，並繼續推進我們的商業準備，以便我們能夠在獲得批准後快速有效地推出 3107。

And finally, I would like to emphasize what's at the heart of the progress I've outlined here today, the potential to change the treatment paradigm for RRP, a debilitating rare disease. We continue to be driven by the fact that every day and every surgery matters to RRP patients and to our mission. Thank you for your attention, and good evening, everyone.

最後，我想強調我今天在此概述的進展的核心，即改變 RRP（一種使人衰弱的罕見疾病）治療模式的潛力。我們始終堅信，每一天、每一次手術對 RRP 患者和我們的使命都至關重要。謝謝大家的關注，大家晚上好。

Ladies and gentlemen, this concludes your conference call for today. We thank you for participating and ask that you please disconnect your lines.

女士們、先生們，今天的電話會議到此結束。感謝您的參與，並請您斷開線路。