Inovio Pharmaceuticals Inc (INO) 2025 Q3 法說會逐字稿

Good afternoon, ladies and gentlemen, and welcome to the INOVIO third-quarter 2025 financial results conference call. (Operator Instructions) This call is being recorded on Monday, November 10, 2025.

女士們、先生們，下午好，歡迎參加 INOVIO 2025 年第三季財務業績電話會議。（操作員指示）本次通話於2025年11月10日星期一進行錄音。

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

現在我謹將會議交給珍妮‧威爾森。謝謝。請繼續。

Good afternoon, and thank you for joining the INOVIO third-quarter 2025 financial results conference call. Joining me today 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.

下午好，感謝各位參加 INOVIO 2025 年第三季財務業績電話會議。今天與我一起參加電話會議的有：總裁兼執行長 Jacqui Shea 博士；首席醫療官 Mike Sumner 博士；首席財務官 Peter Kies；以及首席商務官 Steve Egge。

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

在今天的電話會議上，我們將回顧截至 2025 年 9 月 30 日的季度公司和財務信息，並提供一般業務最新情況。在發言結束後，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 of our request for priority review by the FDA of our BLA submission for INO-3107, and our expectation that the FDA will accept the submission by the end of 2025, along with capital resources, including the sufficiency of our cash resources; our expectations regarding competition; the size and growth of the potential markets for INO-3107, if approved, and our ability to serve those markets; the rate and degree of market acceptance of INO-3107; and strategic matters.

在本次電話會議中，我們將對未來事件和公司的未來表現做出前瞻性陳述。這些事件與我們開發 INOVIO DNA 藥物平台的業務計劃有關，其中包括臨床和監管進展、臨床數據公佈的時間安排、我們向 FDA 提交的 INO-3107 生物製品許可申請 (BLA) 的優先審查請求的計劃時間，以及我們預期 FDA 將在 2025 年底前接受該申請，同時還涉及資本資源，包括我們現金的期望的潛在市場規模和成長，以及我們服務這些市場的能力；INO-3107 的市場接受度和速度；以及策略事項。

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. 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.

以上所有陳述均基於管理階層截至目前的信念和預期。實際事件或結果可能與此有重大差異。我們建議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新聞稿中所述內容存在重大差異的重要因素。本次電話會議正在進行網絡直播，您可以在我們的網站 ir.inovio.com 上找到鏈接，會議結束後不久即可觀看回放。

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

現在我將把電話交給 INOVIO 的總裁兼執行長 Jacqui Shea 博士。

Good afternoon, and thank you for joining today's call. Today, I'm very pleased to share some important updates on the key progress we've made recently. First and foremost, we have achieved our primary objective for this year, which is completing the rolling submission of our BLA for INO-3107. This represents a milestone in our work to deliver on the promise of DNA medicine for the RRP community and is our first BLA submission, an important moment for INOVIO as well.

下午好，感謝各位參加今天的電話會議。今天，我非常高興地與大家分享我們近期取得的一些重要進展。首先，我們已經實現了今年的主要目標，即完成了 INO-3107 的滾動式 BLA 提交。這代表著我們在為 RRP 患者群體實現 DNA 藥物承諾方面取得的里程碑式進展，也是我們首次提交 BLA，對 INOVIO 而言也是一個重要的時刻。

We are now focused on the next steps in the process of bringing 3107 to patients. First, we expect to receive file acceptance by the FDA by year-end, and we have requested a priority review of the BLA, which, if granted, would provide for a potential PDUFA date around mid-2026.

我們現在專注於將 3107 帶給患者的後續步驟。首先，我們預計在年底前獲得 FDA 的文件受理，並且我們已經請求對 BLA 進行優先審查，如果獲得批准，則預計在 2026 年年中左右獲得 PDUFA 批准。

Second, we are continuing to drive commercial efforts forward in preparation for a swift and efficient launch, if approved. Although we will be second to market, we continue to believe that INO-3107 has compelling advantages that could make it the preferred treatment by RRP patients and their health care providers based on its clinical results and tolerability to date and the simplicity of its patient-centric treatment regimen.

其次，我們正在繼續推動商業化進程，為一旦獲得批准即可迅速且有效率地推出產品做好準備。儘管我們可能在市場上排名第二，但我們仍然相信 INO-3107 具有令人信服的優勢，根據其迄今為止的臨床結果和耐受性以及以患者為中心的治療方案的簡便性，它有可能成為 RRP 患者及其醫療保健提供者的首選治療方案。

As we work toward a potential launch date for our first commercial product, we're also advancing our next-generation DNA medicine candidates. I'm pleased to report that landmark, proof-of-concept data on our DNA-encoded monoclonal antibody, or, DMAb, technology was recently published in Nature Medicine. We are also preparing for an upcoming presentation of promising preclinical data from our DNA-encoded protein, or DPROT, technology at the World Federation of Hemophilia Global Forum.

在努力確定首款商業產品的潛在上市日期的同時，我們也正在推動下一代 DNA 藥物候選產品的研發。我很高興地報告，我們DNA編碼單株抗體（DMAb）技術的里程碑式概念驗證數據最近發表在《自然醫學》雜誌上。我們也準備在世界血友病聯盟全球論壇上展示我們 DNA 編碼蛋白（DPROT）技術的有前景的臨床前數據。

Both of these programs leverage a key strength of our DNA medicine platform, the ability to drive sustained, targeted protein production within the body. We believe our DMAb and DPROT technologies have immense potential to treat multiple diseases, and I look forward to sharing more on our progress in the coming months.

這兩個項目都利用了我們 DNA 藥物平台的一個關鍵優勢，即在體內持續、有針對性地生產蛋白質的能力。我們相信我們的 DMAb 和 DPROT 技術具有治療多種疾病的巨大潛力，我期待在接下來的幾個月與大家分享我們取得的更多進展。

Now I'll turn it over to Mike for some additional details about our regulatory progress and next steps for 3107. Mike?

現在我將把發言權交給 Mike，讓他詳細介紹我們在監管方面取得的進展以及 3107 的下一步措施。麥克風？

Thanks, Jacqui. This is indeed a pivotal moment for our RRP program and for INOVIO. We completed the rolling submission of our BLA on October 30, submitting a strong application package that we believe clearly articulates the clinical efficacy of 3107 and demonstrates a tolerable safety profile in clinical trials to date. We submitted under the accelerated-approval pathway and have requested a priority review. So we anticipate file acceptance by year-end, and if priority review is granted, a PDUFA date potentially mid next year.

謝謝你，杰奎。這確實是我們的 RRP 專案和 INOVIO 的關鍵時刻。我們於 10 月 30 日完成了 BLA 的滾動提交，提交了一份強有力的申請材料，我們相信該材料清楚地闡述了 3107 的臨床療效，並證明了迄今為止臨床試驗中可耐受的安全性。我們已依照加速審批途徑提交申請，並請求優先審查。因此，我們預計到年底將接受該文件，如果優先審查獲得批准，PDUFA 日期可能會在明年年中確定。

In the meantime, we are preparing for our pre-approval inspections for both in-house and external manufacturing sites. And you may remember that the FDA completed our clinical inspection in August this year.

同時，我們正在為內部和外部生產場所的預審批檢查做準備。您可能還記得，FDA 於今年 8 月完成了我們的臨床檢查。

We are also working to finalize our confirmatory trial plans. We had previously aligned with the FDA on a design for a randomized, placebo-controlled trial based on guidance indicating that a placebo control arm was required for an indication in patients who had two or more surgeries in the year prior to treatment.

我們目前也正在努力敲定驗證性試驗方案。我們先前已與 FDA 就一項隨機、安慰劑對照試驗的設計達成一致，該設計基於以下指導：對於在治療前一年內接受過兩次或兩次以上手術的患者，需要設立安慰劑對照組。

We now recognize that the landscape has changed following the recent full approval of Papzimeos, including how the FDA might view data requirements to support product approvals. The agency has confirmed that we only need to have initiated the confirmatory trial and enrolled the patient prior to approval, which we believe is achievable based upon our progress to date.

我們現在認識到，隨著 Papzimeos 最近獲得全面批准，情況已經發生了變化，包括 FDA 可能如何看待支持產品批准的數據要求。該機構已確認，我們只需在獲得批准之前啟動驗證性試驗並招募患者即可，根據我們迄今為止的進展，我們認為這是可以實現的。

As you will recall, we are working with more than 20 US academic sites and have made significant progress with site-initiation activities which should enable us to rapidly initiate our confirmatory trial and deliver results in a timely manner. We nevertheless want the opportunity to further discuss potential options for our confirmatory trial design with the agency and have submitted a request for a Type D meeting.

您應該還記得，我們​​正在與 20 多個美國學術機構合作，並在機構啟動活動方面取得了重大進展，這將使我們能夠迅速啟動驗證性試驗並及時提供結果。儘管如此，我們仍然希望有機會與該機構進一步討論我們確認性試驗設計的潛在方案，並已提交了召開 D 類會議的請求。

With a potential approval approaching, I'd like to take a moment to highlight the strengths of our RRP program, strengths that have been foundational to our progress so far and that I believe have the potential to position 3107 as a paradigm-shifting treatment preferred by patients and their health care providers.

隨著潛在的批准即將到來，我想藉此機會強調我們 RRP 計畫的優勢，這些優勢是我們迄今為止取得進展的基礎，我相信這些優勢有可能使 3107 成為患者及其醫療保健提供者首選的、具有範式轉移意義的治療方法。

First, we believe that there is a significant unmet need among the adult RRP patient community, even with an approved treatment on the market, and they deserve to have therapeutic options that work for them to reduce the number of surgeries needed to control their debilitating rare disease. Next, 3107 has a mechanism of action that elicited an antigen-specific T cell response that corresponded to a reduction in surgery in our Phase 1/2 trial.

首先，我們認為，即使市面上已有核准的治療方法，成人 RRP 患者群體仍存在巨大的未滿足需求，他們應該擁有適合自己的治療選擇，以減少控制這種罕見疾病所需的手術次數。其次，3107 的作用機制引發了抗原特異性 T 細胞反應，這與我們 1/2 期試驗中手術量的減少相對應。

In fact, the majority of patients experienced fewer surgeries with most experiencing a 50% to 100% reduction compared to the year before treatment. That clinical benefit continued to improve for most patients in the second 12-month period post treatment without additional dosing.

事實上，大多數患者的手術次數減少了，與治療前一年相比，大多數患者的手術次數減少了 50% 到 100%。在治療後的第二個 12 個月期間，大多數患者的臨床效益持續改善，無需額外給藥。

I also want to highlight that our innovative CELLECTRA administration technology is an integral part to the effectiveness of INO-3107, enabling the targeted, localized delivery of a DNA immunotherapy and offering a simple, effective, and well-tolerated treatment experience. Building on these foundational strengths, I think what really sets 3107 apart is its potential to address the biggest concern that RRP community has shared time and again.

我還要強調，我們創新的 CELLECTRA 給藥技術是 INO-3107 療效不可或缺的一部分，它能夠實現 DNA 免疫療法的標靶局部遞送，並提供簡單、有效且耐受性良好的治療體驗。基於這些基礎優勢，我認為 3107 的真正獨特之處在於它有可能解決 RRP 社群一次又一次表達的最大擔憂。

First and foremost, we know that RRP patients, every single surgery matters. As we shared at the European Society for Medical Oncology Congress recently, INO-3107 demonstrated continued clinical benefit with a persistent decline in the mean number of surgeries through year-two post therapy. For patients, that means a substantially lower average number of surgeries per year, a 78% drop from baseline to year two, meaning less exposure to the risks and costs of surgery.

首先，我們知道對於 RRP 患者來說，每一次手術都至關重要。正如我們最近在歐洲腫瘤內科學會大會上分享的那樣，INO-3107 顯示出持續的臨床益處，治療後第二年平均手術次數持續下降。對於患者而言，這意味著每年平均手術次數大幅減少，從基線到第二年下降了 78%，這意味著患者面臨的手術風險和成本降低。

We also believe one of the key strengths of our DNA medicine platform is the ability to continue treatment beyond the initial treatment regimen, further enhancing the immune response as we have demonstrated with other HPV-targeted DNA medicines. We believe this provides an opportunity to consider a longer-term treatment strategy to potentially extend or further improve clinical response, which is important for a chronic, often lifelong, virally mediated disease.

我們也認為，我們DNA藥物平台的關鍵優勢之一是能夠在初始治療方案結束後繼續治療，進一步增強免疫反應，正如我們在其他HPV標靶DNA藥物中所證明的那樣。我們認為這提供了一個機會，可以考慮制定更長期的治療策略，以期延長或進一步改善臨床療效，這對於慢性、通常終身的病毒性疾病非常重要。

The RRP community has also been very clear in their goal to make surgery a last resort, not a first-line treatment. As I said earlier, that was top of mind when we set out to study 3107, and our treatment regimen stands in stark contrast to Precigen's recently approved product. In their clinical trial prior to the third and fourth doses, patients were scoped to identify any residual papilloma tissue. And if anyone was -- if any was found, a surgery was performed to maintain what is referred to as minimal residual disease, or MRD.

RRP 群體也非常明確地表示，他們的目標是將手術作為最後的手段，而不是第一線治療方案。正如我之前所說，當我們開始研究 3107 時，這是我們最先考慮的問題，我們的治療方案與 Precigen 最近核准的產品形成了鮮明的對比。在第三劑和第四劑先前的臨床試驗中，醫生對患者進行了內視鏡檢查，以確定是否有殘留的乳頭狀瘤組織。如果發現任何殘留病灶，就會進行手術以控制所謂的微小殘留病灶（MRD）。

This process is reflected in the dosage and administration section of the prescribing information. They report these surgeries are performed to mitigate the effect of the immunosuppressive papilloma microenvironment and maximize the chance of clinical benefit for their product.

這個過程體現在處方資訊的劑量和給藥方法部分。他們報告稱，進行這些手術是為了減輕免疫抑制性乳頭瘤微環境的影響，並最大限度地提高其產品獲得臨床益處的機會。

To what does this requirement for maintenance of MRD during the dosing window mean for patients? 83% of patients in their clinical study underwent at least one of these surgeries, with 40% undergoing surgery at both time points. For the patients who later went on to have a complete response, 72% of patients, or 13 out of 18, received surgery in the dosing window. These MRD surgeries during the dosing window were not counted against their efficacy endpoint as they only started counting surgeries following completion of dosing. In contrast, in our trial for 3107, we counted every surgery following the first day of treatment against our endpoint.

對於病人而言，在給藥窗口期內維持 MRD 的要求意味著什麼？在他們的臨床研究中，83% 的患者至少接受過一次此類手術，40% 的患者在兩個時間點都接受了手術。對於後來完全緩解的患者，72% 的患者（即 18 人中的 13 人）在給藥窗口期內接受了手術。在給藥窗口期內進行的這些 MRD 手術不計入其療效終點，因為他們只在給藥完成後才開始統計手術。相較之下，在我們對 3107 例患者的試驗中，我們將治療第一天後的每一次手術都計入了我們的終點。

We believe that every patient deserves a treatment that reduces the number of surgeries they face, and that includes any surgeries that are part of a treatment regimen. That's just one of the core reasons we see so much potential for 3107, and believe it could become the product of choice for RRP patients and providers.

我們認為，每位患者都應該得到能夠減少所面臨手術次數的治療，這包括作為治療方案一部分的任何手術。這只是我們認為 3107 具有巨大潛力的核心原因之一，我們相信它可能會成為 RRP 患者和醫療服務提供者的首選產品。

With that, I'll turn it over to our Chief Commercial Officer, Steve Egge, to provide an update on the commercial front. Steve?

接下來，我將把發言權交給我們的首席商務官史蒂夫·埃格，讓他介紹一下商業方面的最新情況。史蒂夫？

Thanks, Mike. I'd like to start with why we're confident that 3107 has the potential to become the product of choice in the RRP market. A key advantage for 3107 is a positively differentiated product profile that I believe will appeal to laryngologists and to their RRP patients who are looking for an effective, well-tolerated treatment that minimizes exposure to the risks and costs of surgery, including during the treatment window. And this belief is founded on market research.

謝謝你，麥克。首先我想談談我們為什麼有信心 3107 有潛力成為 RRP 市場的首選產品。3107 的一個關鍵優勢是其具有積極差異化的產品特性，我相信這將吸引喉科醫生及其 RRP 患者，他們正在尋找一種有效、耐受性良好的治療方法，以最大限度地減少手術的風險和成本，包括在治療窗口期內。這種觀點是基於市場調查得出的。

The physicians we've spoken to were most interested in the fact that the vast majority of patients saw a significant benefit of 50% to 100% reduction in surgeries from 3107. And for many of them, that benefit continued to improve over time. Physicians were similarly impressed with the tolerability data, which shows that 3107 was generally well tolerated, limiting the impact on patients' return to daily life. This is very important when considering the treatment protocol includes four doses over a relatively short period of time.

我們訪談的醫生最感興趣的是，絕大多數患者從 3107 年開始就獲得了顯著的益處，手術次數減少了 50% 到 100%。對他們中的許多人來說，這種益處隨著時間的推移而不斷提高。醫生對耐受性數據同樣印象深刻，數據顯示 3107 整體耐受性良好，限制了對患者恢復日常生活的影響。考慮到治療方案需要在相對較短的時間內進行四次給藥，這一點非常重要。

And in terms of the treatment regimen itself, 3107 offers a more patient-centric approach that takes into account real concerns of both physicians and their RRP patients. It can be administered in the physician's office without an ultracold chain requirement. The device is simple to use. And as Mike noted, very importantly, there's no requirement for minimum residual disease surgeries during the treatment window.

就治療方案本身而言，3107 提供了一種以患者為中心的更全面的方法，充分考慮了醫生和 RRP 患者的實際擔憂。無需超冷鏈，即可在醫師診間進行給藥。該設備使用起來很簡單。正如麥克指出的那樣，非常重要的一點是，在治療窗口期內沒有要求進行最小殘留病灶手術。

We believe, and the market research supports, that there are many laryngologists and RRP patients who, given a choice, don't want to risk additional surgeries as part of the treatment that is intended to provide relief from surgery. And finally, as Mike noted, 3107 has been studied in a broad population of RRP patients, specifically in patients with as few as two surgeries during the year prior to treatment.

我們相信，市場調查也支持這一觀點，許多喉科醫生和復發性呼吸道乳頭狀瘤病 (RRP) 患者，如果可以選擇，都不願冒著再次手術的風險，作為旨在緩解手術痛苦的治療的一部分。最後，正如 Mike 指出的那樣，3107 已在廣泛的 RRP 患者群體中進行了研究，特別是治療前一年內接受過兩次手術的患者。

We believe it's important for patients to start treatment as soon as possible after diagnosis to avoid the risk of irreversible damage from repeated surgery. Of course, in addition to these strengths, we'll learn from the launch of Papzimeos, and we will plan to be a fast follower in a market that we believe will continue to have significant unmet need when we enter.

我們認為，患者確診後應盡快開始治療，以避免因反覆手術而造成不可逆的損害。當然，除了這些優勢之外，我們還會從 Papzimeos 的推出中吸取經驗，併計劃迅速跟進我們認為在我們進入市場後仍將存在巨大未滿足需求的市場。

Moving now to a few updates on launch preparations. We've continued on pace with our regulatory progress. Since our last quarterly report, we've made noted progress on both the market research and operational fronts. We've continued critical research with payers, developed our initial pricing strategy, commenced price optimization work, and completed targeting-segmentation and product-positioning work supporting a positively differentiated product profile.

接下來介紹一些關於發布準備工作的最新進展。我們的監管工作進展一直按計劃進行。自從上一季報告發布以來，我們在市場調查和營運方面都取得了顯著進展。我們繼續與支付方進行關鍵研究，制定了初步定價策略，開始了價格優化工作，並完成了目標細分和產品定位工作，從而支持了具有積極差異化的產品形象。

We're preparing for commercialization. We're finalizing contracts with our specialty distributor, specialty pharmacy, and patient-hub partners; finalizing our go-to-market model; and advancing the build-out of our commercial organization. I look forward to providing more updates on our progress next quarter as we further advance our commercial preparations. We're planning to get out of the gate quickly if approved, and I'm excited about the opportunity to bring this much-needed treatment to the RRP community.

我們正在為商業化做準備。我們正在敲定與專業經銷商、專業藥房和患者中心合作夥伴的合約；敲定我們的市場推廣模式；並推進我們商業組織的建設。我期待在下個季度向我們提供更多進展信息，因為我們將進一步推進商業準備工作。如果獲得批准，我們將迅速啟動，我很高興有機會為 RRP 患者群體帶來這種急需的治療方法。

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

接下來，我將把發言權交給彼得，讓他報告財務狀況。彼得？

Thanks, Steve. Today, I'd like to provide an overview of INOVIO's financial results for the third-quarter 2025 and provide a snapshot of the year so far. I am pleased to report that we have continued to align our resources to support the development of our lead candidate, INO-3107, and we will be focused on the critical needs ahead as we work towards a potential launch in mid-2026.

謝謝你，史蒂夫。今天，我想概述一下INOVIO 2025年第三季的財務業績，並簡要介紹今年迄今為止的情況。我很高興地報告，我們已繼續調整資源以支持我們主要候選藥物 INO-3107 的開發，我們將專注於未來的關鍵需求，努力爭取在 2026 年年中推出該產品。

As you can see here, we've continued to reduce our operating expenses over the past year. Operating expenses dropped from $27.3 million in the third quarter of 2024 to $21.2 million in the third quarter of 2025, a 22% decrease. When you look at the first nine months of 2025, we reduced operating expenses by 25% compared to the same time period last year.

正如您所看到的，在過去一年中，我們持續降低了營運費用。營運支出從 2024 年第三季的 2,730 萬美元降至 2025 年第三季的 2,120 萬美元，降幅達 22%。從 2025 年前九個月的情況來看，與去年同期相比，我們的營運支出減少了 25%。

Our net loss for the quarter increased to $45.5 million or $0.87 per share basic and dilutive, primarily driven by a $22.5 million noncash loss on fair value adjustments related to our warrant liabilities. As the fair value of the warrants fluctuate with our share price and other market inputs, this adjustment can result in significant variability in our reported net loss. However, the net loss from operations prior to other income and expense items for the third quarter of 2025 decreased 25 -- 22% to $21.2 million from a loss from operations of $27.3 million in the third quarter of 2024.

本季淨虧損增至 4,550 萬美元，即每股基本虧損和稀釋虧損 0.87 美元，主要原因是與認股權證負債相關的公允價值調整導致 2,250 萬美元的非現金損失。由於認股權證的公允價值會隨著我們的股價和其他市場因素而波動，因此這種調整可能會導致我們報告的淨虧損出現重大波動。然而，2025 年第三季在扣除其他收入和支出項目之前的淨營業虧損減少了 25 - 22%，至 2,120 萬美元，而 2024 年第三季營運虧損為 2,730 萬美元。

On a per share basis, both basic and dilutive, the loss from operations for the third quarter of 2025 dropped 58% to $0.41 per share from $0.97 per share for the third quarter of 2024. You can see similar reductions in our net loss from operations for the first nine months of 2025 versus 2024 as we continue to conserve and direct our resources to support the 3107 program. We finished the quarter of 2025 with $50.8 million in cash, cash equivalents and short-term investments compared to $94.1 million as of December 31, 2024.

以每股計算，無論是基本虧損還是稀釋虧損，2025 年第三季的經營虧損從 2024 年第三季的每股 0.97 美元下降 58% 至每股 0.41 美元。您可以看到，由於我們繼續節約資源並引導資源支持 3107 計劃，2025 年前九個月的營運淨虧損與 2024 年相比也有類似的減少。截至 2025 年第一季末，我們持有現金、現金等價物和短期投資 5,080 萬美元，而截至 2024 年 12 月 31 日，這一數字為 9,410 萬美元。

We estimate our cash runway to take us into the second quarter of 2026. This projection includes a net operational cash burn estimate of approximately $22 million for the fourth quarter of 2025. These cash runway projections do not include any further capital-raise 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 with the SEC today.

我們預計現金流可以維持到 2026 年第二季。該預測包括 2025 年第四季約 2,200 萬美元的淨營運現金消耗估計。這些現金儲備預測不包括我們可能進行的任何其他融資活動。再次提醒，您可以在今天下午的新聞稿以及今天向美國證券交易委員會提交的季度報告（10-Q 表格）中找到我們的完整財務報表。

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

那麼，我就把麥克風交還給傑奎琳了。

Thanks, Peter. While our primary focus continues to be on 3107 and a potential launch mid next year, we see immense opportunity across the rest of our pipeline as well. We're excited about the potential we see for INO-3112 for head and neck cancer, and INO-5401 for glioblastoma as well as a potential cancer-prevention treatment in people with BRCA mutations. And while we're currently focusing resources on 3107, we look forward to exploring opportunities to advance those programs.

謝謝你，彼得。雖然我們的主要關注點仍然是 3107 以及明年年中可能推出的產品，但我們也看到了我們其他產品線中的巨大機會。我們對 INO-3112 在治療頭頸癌方面的潛力，以及 INO-5401 在治療膠質母細胞瘤方面的潛力感到興奮，同時我們也對 INO-5401 作為潛在的癌症預防療法在 BRCA 突變患者中的應用感到興奮。雖然我們目前將資源集中用於 3107 項目，但我們期待探索推進這些項目的機會。

And as I mentioned during my opening comments, earlier in the clinical pipeline, proof-of-concept data on INOVIO's DMAb technology was recently published in Nature Medicine. This study, led by the Wistar Institute in collaboration with INOVIO, AstraZeneca, and clinical investigators at the Perelman School of Medicine at the University of Pennsylvania, was the first clinical demonstration that monoclonal antibodies, which are complex proteins, can be durably and tolerably produced within the human body without generating antidrug antibodies.

正如我在開場白中提到的，在臨床研發的早期階段，INOVIO 的 DMAb 技術的概念驗證數據最近已發表在《自然醫學》雜誌上。這項研究由威斯塔研究所牽頭，與INOVIO、阿斯特捷利康以及賓州大學佩雷爾曼醫學院的臨床研究人員合作開展，首次在臨床上證明，單株抗體（一種複雜的蛋白質）可以在人體內持久且耐受地產生，而不會產生抗藥性抗體。

Our DPROT technology builds on this research and our promising preclinical work evaluating the potential to expand into vivo production of therapeutic proteins will be presented this week at the World Federation of Hemophilia Global Forum, including our first research from Factor VIII production. Our DPROT's approach aims to address some of the shortcomings of conventional therapeutic protein replacement treatments, including gene therapy approaches. As we work to bring the first approved DNA medicine to the United States, we are actively looking for future partnerships and development opportunities to advance these and other promising candidates across our pipeline.

我們的 DPROT 技術建立在這項研究的基礎上，我們評估擴大體內治療性蛋白質生產的潛力的有前景的臨床前工作將於本週在世界血友病聯盟全球論壇上進行展示，其中包括我們首次開展的 VIII 因子生產研究。我們的 DPROT 方法旨在解決傳統治療性蛋白質替代療法（包括基因療法）的一些缺點。在我們努力將首個獲批的 DNA 藥物引入美國的同時，我們正在積極尋找未來的合作夥伴關係和發展機會，以推進這些以及我們研發管線中其他有前景的候選藥物的研發。

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

現在我開放通話，回答大家可能有的任何問題。操作員？

(Operator Instructions)

（操作說明）

Ted Tenthoff, Piper Sandler.

泰德·滕索夫，派珀·桑德勒。

Thanks for all of the update. When it comes to Papzimeos, have you guys heard if they've officially launched yet? And I'm wondering how big of a deal do you think this head start that they have is, especially in a market where it's going to be a lot about education and educating physicians about new therapeutic options?

感謝您提供的所有最新資訊。關於 Papzimeos，你們聽說他們正式上線了嗎？我想知道你認為他們獲得的這種先發優勢有多重要，尤其是在一個非常注重教育，需要向醫生普及新療法的市場中？

Thanks, Ted. Yes. So what we've heard from their public statements is that Papzimeos became available to order as of October 21. So Steve, do you want to talk about our expectations of being a fast follower and how we see our market entry?

謝謝你，泰德。是的。從他們的公開聲明中我們了解到，Papzimeos 從 10 月 21 日起開始接受預訂。史蒂夫，你想談談我們作為快速追隨者的預期以及我們如何看待進入市場嗎？

Sure. So we would expect, when we look at rare-disease analogies, that when the time period kind of between when they're out and when we would expect to be approved in mid-'26, if the current time line holds, we would expect single-digit penetration into the prevalent population in that time period. So at the time we enter, the majority of the prevalent population will be available. Obviously, the incident annual diagnosed patients will be available.

當然。因此，當我們以罕見疾病為例進行類比時，我們預計，如果目前的進度保持不變，那麼在藥物上市到我們預計在 2026 年中期獲得批准的這段時間內，藥物在流行人群中的滲透率將只有個位數。因此，當我們進入遊戲時，大部分人口都將可以參與。顯然，每年確診患者的事件數據將會公佈。

And then over time, we've talked about, we would expect continued treatment or redosing also to represent an opportunity. So by the time we arrive, the vast majority of the opportunity will remain. And like we've talked about previously, we do expect to have the preferred product profile in this space. So over time, we think there's still a significant opportunity, of course, for 3107.

然後隨著時間的推移，正如我們之前討論過的，我們預計持續治療或再次給藥也將代表著一種機會。所以等到我們到達時，絕大多數機會仍將存在。正如我們之前討論過的，我們確實期望在這個領域擁有首選的產品定位。所以從長遠來看，我們認為 3107 當然還有很大的發展機會。

Jay Olson, Oppenheimer.

傑伊·奧爾森，奧本海默。

Congrats on the progress. Our first question is, do you expect to have a similar label for 3107 versus Papzimeos? And do you think the requirement for debulking with Papzimeos is something that could present a key differentiator in the label for 3107?

恭喜你取得進展。我們的第一個問題是，您是否預期 3107 和 Papzimeos 會有類似的標籤？您認為使用 Papzimeos 進行減容的要求是否會成為 3107 標籤上的關鍵差異化因素？

And then our second follow-up question is related to I think you mentioned you're still planning to run a pivotal study for full FDA approval. Is that study also required for ex-US approval?

那麼，我們的第二個後續問題與你剛才提到的你仍然計劃進行一項關鍵性研究以獲得 FDA 的全面批准有關。這項研究也是美國以外地區獲得批准的必要條件嗎？

Thanks, Jake. Great question. So Mike, maybe I can ask you to take the label question, first of all.

謝謝你，傑克。問得好。所以麥克，首先，或許我可以請你回答一下標籤的問題。

Yeah, certainly. So I mean, from a patient-population perspective, we study the broad population. We had two to eight surgeries pre-treatment with INO-3107. And we demonstrated clinical efficacy across the entire range of surgeries. As you are aware, we have a well-tolerated product profile. So we do believe our data would justify a broad label similar to what Papzimeos received.

當然可以。所以我的意思是，從患者群體的角度來看，我們研究的是廣大患者群體。在接受 INO-3107 治療之前，我們進行了 2 到 8 次手術。我們已證明該方法在所有手術類型中均具有臨床療效。如您所知，我們的產品具有良好的耐受性。因此，我們相信我們的數據足以證明，Papzimeos 所獲得的標籤是廣泛的。

So in terms of the minimal residual disease surgeries that Precigen's treatment regimen requires, we do think that, that's going to be a really key differentiator. What we're hearing from our market research is physicians have questions around the logistics of scheduling those surgeries, so do payers as well.

因此，就 Precigen 治療方案所需的微小殘留病灶手術而言，我們認為這將是一個真正關鍵的區別因素。我們從市場調查中了解到，醫生們對安排這些手術的後勤工作有疑問，支付者也有同樣的疑問。

So we think in addition to what it means for patients, patients clearly don't want to undergo additional surgeries as part of the treatment regimen. But just from the logistical point of view as well, it also creates some challenges.

因此，我們認為，除了對患者而言意味著什麼之外，患者顯然不希望在治療方案中接受額外的手術。但從後勤角度來看，這也帶來了一些挑戰。

Steve, Mike, I don't know if you'd like to add to that.

史蒂夫，麥克，不知道你們是否還有補充。

No, I think you've covered it.

不，我覺得你已經講清楚了。

Yeah. I think that's good.

是的。我覺得這樣很好。

And then in terms of the confirmatory trial, Mike?

那麼，關於確認性審判，麥克？

Yeah. So I mean, obviously, you heard me say today that we have submitted a Type D meeting request to the agency to align on what that confirmatory study is going to look like. It's difficult to say exactly the value of that study to a European filing without knowing the exact design.

是的。所以我的意思是，很顯然，你們今天都聽到我說，我們已經向該機構提交了 D 類會議請求，以確定該確認性研究的具體形式。在不了解具體設計的情況下，很難準確判斷這項研究對歐洲專利申請的價值。

But -- and clearly, any data collected under -- in a rigorous manner is going to help define our efficacy and safety profile. So I think any study that we perform will be of value to our European filing.

但是——而且顯然——任何以嚴格方式收集的數據都將有助於確定我們的療效和安全性概況。所以我認為我們進行的任何研究都將對我們的歐洲備案工作有價值。

Great. Congrats again on the progress.

偉大的。再次恭喜你取得的進展。

Sudan Loganathan, Stephens.

蘇丹·洛加納坦，史蒂芬斯。

Congrats on the quarter. This is Felix Ampomah for Sudan. I have one or two questions. Number one, can you please comment on the sales-force preparedness post 3107 approval? And then secondly, if 3107 is approved, given that it's a DNA-based medicine and also Papzimeos is virus-based, can you comment on switching from Papzimeos to 3107, if there wouldn't be any cross-reactivity issues there?

恭喜你本季取得佳績。這是費利克斯·安波馬代表蘇丹發回的報道。我還有一兩個問題。首先，請問您對 3107 號提案核准後銷售團隊的準備有何評價？其次，如果 3107 獲得批准，鑑於它是一種基於 DNA 的藥物，而 Papzimeos 是基於病毒的藥物，您能否評論一下從 Papzimeos 換用 3107 是否會有任何交叉反應問題？

Great questions, Felix. So maybe, Steve, you can take the commercial-readiness question.

菲利克斯，問得好。所以，史蒂夫，或許你可以來回答商業化準備的問題。

Yeah. So we're -- as I mentioned in the prepared comments, we're advancing our launch preparations. In terms of what a field force would look like, we are planning to have MSLs as well as an access team out ahead of approval to begin to engage in scientific exchange as well as work with payers on pre-approval information exchange.

是的。正如我在準備好的演講稿中提到的，我們正在推動發射準備。就現場推廣團隊的組成而言，我們計劃在產品獲批前安排醫學聯絡官 (MSL) 和准入團隊，以便開始進行科學交流，並與支付方合作進行獲批前的信息交流。

And then we haven't guided in terms of the timing on the sales force. You've probably heard Precigen has shared that they expect a sales team of 18 or 18 territories. And I think it's a safe assumption that we would be kind of in that neighborhood, but we haven't provided specific guidance there. But we're certainly advancing commercial plans and plan to get out of the gate very, very quickly post approval.

而且，我們在銷售團隊的時間安排方面也沒有提供指導。你可能已經聽說 Precigen 表示，他們預計銷售團隊將涵蓋 18 或 18 個不同的銷售區域。我認為我們可以合理地假設我們大致處於那個範圍內，但我們還沒有提供具體的指導。但我們肯定會推進商業計劃，並計劃在獲得批准後迅速啟動。

And then, Mike, the cross-reactivity?

那麼，麥克，交叉反應呢？

Yeah, certainly. So there's certainly no reason to suspect there would be any cross-reactivity issues for patients who have previously received Papzimeos to receive INO-3107. The one thing we would anticipate, though, is it will be important to give the entire treatment regimen as clearly. We present different epitopes to patients, so they will need to have all four courses of the treatment.

當然可以。因此，完全沒有理由懷疑先前接受過 Papzimeos 治療的患者在接受 INO-3107 治療時會出現任何交叉反應問題。不過，我們預計，必須清楚說明整個治療方案。我們向患者展示不同的表位，因此他們需要接受全部四個療程的治療。

Okay. Thank you, and congrats again.

好的。謝謝，再次恭喜。

Ram Selvaraju, H.C. Wainwright.

拉姆‧塞爾瓦拉朱 (Ram Selvaraju)，H.C.溫賴特。

This is Eduardo on for Ram. I guess some questions related to the DMAb and the DPROT technologies. I was hoping if you could comment a bit on the levels of expression that you're achieving for the DMAb. I know that there was a SARS-CoV neutralizing antibodies that you guys published in Nature Medicine, as you mentioned. Curious about what kind of titers you guys are achieving and if that compares favorably to kind of existing recombinant kind of titers and doses and where you can -- how you're envisioning prioritizing programs within each of these technologies and platforms?

這裡是代表 Ram 的 Eduardo。我想問一些與DMAb和DPROT技術相關的問題。我希望您能就您在DMAb方面所達到的表達水平做一些評論。我知道你們曾在《自然醫學》雜誌上發表過關於SARS-CoV中和抗體的文章，正如你們所提到的。我很想知道你們目前達到的滴度是多少，與現有的重組滴度和劑量相比是否有利，以及在哪些方面——你們打算如何優先考慮每項技術和平台中的項目？

Yeah. That's a really great question. So we're excited around our DMAb technology. In the Nature Medicine paper, we described production of two different monoclonal antibodies against SARS-CoV-2 within the body. We were able to get sustained expression over 72 weeks. We didn't see any antidrug antibodies being produced.

是的。這真是個好問題。所以我們對我們的DMAb技術感到非常興奮。在《自然醫學》論文中，我們描述了體內針對 SARS-CoV-2 的兩種不同單株抗體的產生。我們成功實現了72週的持續表達。我們沒有觀察到任何抗藥性抗體的產生。

And this was a dose-escalation-and-safety study, and we were able to see a dose response with an increasing amount of the DNA medicine being administered and we were able to increase the dose by giving -- sorry, increase the amounts of monoclonal antibodies that we were able to detect in the blood by giving a second dose. So we were able to demonstrate in this first clinical proof-of-concept study, a concentration in the blood of about of over 1 microgram per milligram. And that would certainly put us into the right range for a number of different antibody therapies as well as potentially some protein-replacement candidates as well.

這是一項劑量遞增和安全性研究，我們能夠觀察到隨著DNA藥物給藥量的增加而出現的劑量反應，我們能夠透過給予——抱歉，是透過給予第二劑來增加我們在血液中檢測到的單株抗體的數量，從而增加劑量。因此，在這項首個臨床概念驗證研究中，我們能夠證明血液中的濃度約為每毫克 1 微克以上。這樣一來，我們肯定能夠研發出多種不同的抗體療法，以及一些潛在的蛋白質替代療法。

But this was a first proof-of-concept study. We were able to show that these monoclonal antibodies were functional as well and as functional as the native monoclonal that we designed this program around. So we're -- we think this is very promising and has read through to production of other proteins within the body. At the end of the day, monoclonal antibodies are a complex protein to produce, and we think this data bodes extremely well.

但這只是一項初步的概念驗證研究。我們能夠證明這些單株抗體具有功能性，並且與我們設計該方案所依據的天然單株抗體一樣具有功能性。所以我們認為這非常有前景，並且已經延伸到體內其他蛋白質的產生。歸根究底，單株抗體是一種生產過程複雜的蛋白質，我們認為這些數據預示著非常好的結果。

Great. And any thoughts or comments on what specific programs you're going to potentially prioritize in further development down the line?

偉大的。對於未來可能優先發展的具體項目，您有什麼想法或建議嗎？

Yes. So we've -- this week, we're going to be presenting our first data on some of the preclinical work on some undisclosed targets that we've been conducted -- conducting. And this first target that we're presenting on is Factor VIII for the treatment of hemophilia A.

是的。所以，本週我們將公佈一些針對未公開標靶的臨床前研究的首批數據。我們首先要介紹的是用於治療血友病 A 的 VIII 因子。

As we're progressing these programs, clearly, the majority of our resources are going towards 3107 at the moment supporting the potential launch of 3107. And so we're going to be looking to advance these programs once we get into the clinic through partnerships or once we have additional financial resources available.

隨著我們推進這些項目，很顯然，目前我們的大部分資源都投入了 3107 項目上，以支持 3107 項目的潛在啟動。因此，一旦我們透過合作進入臨床階段，或者一旦我們有了額外的財務資源，我們將尋求推進這些項目。

And there are no further questions at this time. I will now hand the call back to Jacqui Shea for any closing remarks.

目前沒有其他問題了。現在我將把電話轉回給杰奎·謝伊，請她作總結發言。

Thank you. Before we close, I'd like to reiterate the key catalysts ahead. We're now focused on the next milestones for 3107, which include expected BLA file acceptance by year-end and a potential PDUFA date in mid-2026. We'll also finalize our confirmatory trial design with FDA and have this study underway before approval. And we'll continue to advance our commercial preparations so that we'll be ready to launch our first commercial product in the year ahead.

謝謝。在結束之前，我想重申未來的關鍵催化劑。我們現在專注於 3107 的下一個里程碑，其中包括預計在年底前獲得 BLA 文件批准，以及可能在 2026 年年中獲得 PDUFA 批准。我們也將在獲得批准前與FDA敲定驗證性試驗方案，並啟動這項研究。我們將繼續推進商業準備工作，以便在來年推出我們的首款商業產品。

In closing, I'd like to take a moment to thank all the patients, advocates, and doctors of the RRP community who have made our progress with 3107 possible. You are at the heart of our efforts to deliver on the promise of DNA medicine and our mission to provide every RRP patient with effective and durable relief from the devastating cycle of surgical interventions. As always, we're moving forward with the patient in mind, knowing that every day and every surgery matters.

最後，我要藉此機會感謝 RRP 社群的所有病患、倡議者和醫生，正是他們的努力使得 3107 的研發取得進展。您是我們實現 DNA 醫學承諾和使命的核心，我們的使命是為每位 RRP 患者提供有效且持久的緩解，使其擺脫手術幹預帶來的毀滅性循環。一如既往，我們始終以患者為中心，深知每一天、每一次手術都至關重要。

Thank you for your attention, and good evening, everyone.

謝謝大家的關注，大家晚上好。

And this concludes today's call. Thank you for participating. You may all disconnect.

今天的電話會議到此結束。感謝您的參與。你們可以斷開連結了。