Inovio Pharmaceuticals Inc (INO) 2025 Q4 法說會逐字稿

Good afternoon, ladies and gentlemen, and welcome to the Inovio fourth-quarter and full year 2025 financial results conference call. (Operator Instructions) This call is being recorded on Thursday, March 12, 2026.

各位女士、各位先生，下午好，歡迎參加 Inovio 2025 年第四季及全年財務業績電話會議。(接線員指示) 本通話於 2026 年 3 月 12 日（星期四）錄音。

I would now like to turn the call over to Jennie Wilson. Please go ahead.

現在我想把電話交給 Jennie Wilson。請開始。

Good afternoon, and thank you for joining the Inovio fourth-quarter and full year 2025 financial results Conference Call. Joining me on today's call are Dr. Jacqui Shea, President and Chief Executive Officer; Dr. Mike Sumner, Chief Medical Officer; Steve Egge, Chief Commercial Officer; and Peter Kies, Chief Financial Officer.

各位下午好，感謝各位參加 Inovio 2025 年第四季及全年財務業績電話會議。今天與我一同出席的有：總裁兼執行長 Jacqui Shea 博士；首席醫學官 Mike Sumner 博士；首席商務官 Steve Egge；以及首席財務官 Peter Kies。

Today's call will review our corporate and financial information for the quarter and year ended December 31, 2025, as well as provide a general business update. Following prepared remarks, we will conduct a question-and-answer segment. During the call, we will be making forward-looking statements regarding future events and the future performance of the company.

今天的電話會議將回顧截至 2025 年 12 月 31 日止季度及年度的公司與財務資訊，並提供一般業務最新進展。在預先準備的發言之後，我們將進行問答環節。在本次通話中，我們將就未來事件及公司未來表現發表前瞻性陳述。

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 our interactions with the FDA regarding our BLA for INO-3107, including our yet to be scheduled meeting with the FDA to discuss eligibility for the accelerated approval program.

這些事件與我們推進 Inovio DNA 藥物平台之業務計畫相關，其中包括臨床與法規進展、臨床數據讀出時間點及計畫中的法規申報；以及我們就 INO-3107 的 BLA 與 FDA 的互動，包括尚未排定之與 FDA 會議，以討論是否符合加速核准計畫資格。

The potential benefits of INO-3107, along with capital resources including the sufficiency of our cash resources, our expectations regarding competition, the size and growth of the potential market 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.

INO-3107 的潛在效益，以及資本資源（包括我們現金資源是否充足）、我們對競爭的預期、若 INO-3107 獲核准其潛在市場的規模與成長，以及我們服務該等市場的能力。INO-3107 的市場接受度之速度與程度，以及策略性事項。

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 heading Risk Factors, 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.

上述所有陳述均以管理層截至今日的信念與預期為基礎。實際事件或結果可能存在重大差異。我們請各位參閱我們不時向 SEC 提交的文件，其中在「風險因素」標題下列示可能導致實際結果與公司口頭陳述以及今日下午新聞稿所載陳述存在重大差異的重要因素。本通話將以網路直播方式進行，連結可於我們網站 ir.inovio.com 查詢，並將於通話結束後不久提供重播。

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

現在我把電話交給 Inovio 總裁兼執行長 Jacqui Shea 博士。

Good afternoon, and thank you to everyone for joining today's call. These are very exciting times for Inovio with our first BLA for INO-3107 in as a potential treatment for adults with recurrent respiratory papillomatosis or RRP currently being reviewed by the FDA. In late December last year, we were pleased to announce that the FDA accepted our BLA review under the accelerated approval program.

各位下午好，感謝大家參加今天的電話會議。對 Inovio 而言，這是非常令人振奮的時刻：我們針對 INO-3107 的首份 BLA（作為治療成人復發性呼吸道乳頭狀瘤病（recurrent respiratory papillomatosis，RRP）的潛在療法）目前正由 FDA 審查中。去年 12 月下旬，我們很高興宣布 FDA 已在加速核准計畫下受理我們的 BLA 並進行審查。

The FDA granted a standard 10-month review with a Prescription Drug Use of Act or PDUFA target date set for October 30 of this year. While the BLA was accepted under the accelerated approval program, in the file acceptance letter, the FDA noted as a potential review issue, its preliminary conclusion that the company has not provided adequate information to justify eligibility for the accelerated approval program.

FDA 核予標準 10 個月審查期，並將《處方藥使用者付費法》（PDUFA）目標日期訂為今年 10 月 30 日。雖然該 BLA 係在加速核准計畫下獲受理，但在受理函中，FDA 指出一項可能的審查議題：其初步結論認為公司未提供足夠資訊以證明符合加速核准計畫資格。

This preliminary conclusion was made during the initial 60-day filing review period and was the first time a potential issue with respect to eligibility have been raised. As Mike will explain later in the presentation, we strongly believe that INO-3107 does fulfill the criteria for review under the accelerated approval program. By meeting an unmet medical need and providing a meaningful therapeutic benefit over existing treatment.

此一初步結論是在最初 60 天的送件審查期間作出，亦是首次提出與資格相關的潛在問題。如 Mike 稍後在簡報中將說明，我們堅信 INO-3107 確實符合加速核准計畫的審查標準。其原因在於它能滿足未被滿足的醫療需求，並相較既有治療提供具意義的治療效益。

The FDA has agreed to meet with us. We have provided additional documentation, and we're waiting for them to provide a meeting date. In the meantime, we are continuing to advance our commercial preparations, focusing on optimizing and expanding our resources towards our October PDUFA date. To achieve this, Inovio has taken steps to further conserve its financial resources, rescoping projects and activities and eliminating roles that don't directly support our primary goal for advancing INO-3107 towards US approval.

FDA 已同意與我們會面。我們已提供額外文件，目前正等待對方提供會議日期。同時，我們持續推進商業化準備，聚焦於在 10 月 PDUFA 日期前最佳化並擴充資源配置。為達成此目標，Inovio 已採取進一步節省財務資源的措施，重新界定專案與活動範圍，並裁撤未直接支持我們主要目標（推進 INO-3107 取得美國核准）的職位。

These efforts have enabled the extension of our estimated cash runway into the fourth-quarter of this year. While the majority of our resources are directed to advancing our lead candidates towards approval, we are continuing to leverage the power of partnerships to advance other promising candidates in our pipeline. We have recently announced an exciting opportunity to build on our research in glioblastoma to an innovative Phase II adaptive platform trial bolstered by the Dana-Farber Cancer Institute, where we'll collaborate with Akzo, we evaluate INO-5412 in combination with their novel PD-1, CTLA-4 bispecific antibody checkpoint inhibitor.

這些努力使我們預估的現金可支撐期延長至今年第四季。雖然我們的大部分資源都用於推進主要候選產品取得核准，但我們仍持續運用合作夥伴關係的力量，推進管線中其他具前景的候選產品。我們近期宣布一項令人振奮的機會：在我們於膠質母細胞瘤的研究基礎上，推進一項創新的第二期自適應平台試驗，並由 Dana-Farber 癌症研究所加持；我們將與 Akzo 合作，評估 INO-5412 與其新型 PD-1、CTLA-4 雙特異性抗體免疫檢查點抑制劑的聯合治療。

Like our lead program, INO-3107, this program utilizes the antigen-specific cytotoxic T cell generating ability of our DNA medicines platform. But in this instance, the target cancer cells. We have also continued to advance some of our earlier-stage next-generation DNA medicine candidates, which I'll touch on later in this presentation. I look forward to advancing these programs in tandem with our top priority for 2026, achieving FDA approval of our first product and bringing INO-3107 patients.

如同我們的領先計畫 INO-3107，該計畫運用我們 DNA 藥物平台產生抗原特異性細胞毒性 T 細胞的能力。但在此情境下，目標為癌細胞。我們也持續推進一些較早期的下一代 DNA 藥物候選產品，稍後我會在本次簡報中提及。我期待在推進這些計畫的同時，也能達成我們 2026 年的首要優先事項：取得 FDA 對我們第一項產品的核准，並將 INO-3107 帶給患者。

Now I'll turn it over to Mike for some additional insights on our regulatory progress with 3107. Mike?

接下來我把時間交給 Mike，請他就 3107 的法規進展提供更多見解。Mike？

Thanks, Jacqui. As Jacqui outlined, we have made significant progress with our BLA as outlined on this slide, including the acceptance of our file for review under the accelerated approval program, with a PDUFA date of October 30, 2026. We believe our BLA makes a strong argument outlining how INO-3107 and meets an unmet medical need and provides a meaningful therapeutic benefit over existing treatments, thus fulfilling the accelerated approval program criteria.

謝謝你，Jacqui。如 Jacqui 所述，我們在 BLA 方面已取得重大進展，如本投影片所示，包括我們的申請在加速核准計畫下獲受理並進入審查，PDUFA 日期為 2026 年 10 月 30 日。我們相信，我們的 BLA 提出了有力論述，說明 INO-3107 如何滿足未被滿足的醫療需求，並相較既有治療提供具意義的治療效益，因此符合加速核准計畫的標準。

Our next step is to discuss this with the FDA. In preparation for this meeting, they had requested that we complete an assessment aid, which we submitted in February. In this document, we reiterate and expand on our rationale for accelerated approval review. It is important to note that while we wait to meet with the FDA, the BLA is under active review, and we have been responding to routine requests for information.

我們的下一步是與 FDA 討論此事。為準備這次會議，FDA 要求我們完成一份評估輔助文件（assessment aid），我們已於 2 月提交。在該文件中，我們重申並進一步闡述我們支持加速核准審查的理由。需要強調的是，在等待與 FDA 會面期間，BLA 仍在積極審查中，我們也一直在回覆例行性的資訊要求。

In addition, we submitted an updated protocol for our confirmatory trial to the IND and are awaiting feedback from the agency regarding finalizing the study design. I'd like to take a moment to focus on why we believe 3107 meets the accelerated approval criteria. Following the unexpected full approval of in August last year, the regulatory landscape changed with respect to the requirements for eligibility.

此外，我們已向 IND 提交確認性試驗的更新版試驗方案，並正等待主管機關就最終研究設計提供回饋。我想花點時間聚焦於我們為何相信 3107 符合加速核准標準。在去年 8 月出乎意料地獲得完全核准之後，與資格要求相關的法規環境已發生變化。

Based on published FDA guidance, when there's an already approved product, eligibility for accelerated approval depends on a candidate's ability to provide a meaningful therapeutic benefit over existing treatments and its ability to meet a remaining critical unmet need among patients. We believe that 3107 meets both of those criteria based on demonstrated efficacy and improved safety profile that does not include required surgery during the dosing window and a differentiated mechanism of action that provides the ability to treat patients who are not able to be served by existing therapy. Getting into more detail.

根據已發布的 FDA 指引，當已有一項產品獲核准時，加速核准的資格取決於候選產品是否能相較既有治療提供具意義的治療效益，以及是否能滿足患者仍存在的關鍵未被滿足需求。我們相信 3107 依據已證實的療效與更佳的安全性特徵（在給藥期間不包含必須進行的手術），以及具差異化的作用機轉（可治療無法由既有療法服務的患者），因此同時符合這兩項標準。接下來我會更詳細說明。

In our trial, the majority of patients experienced fewer surgeries after treatment with 3107, with most experiencing a 50% to 100% reduction compared to the year before treatment. That clinical benefit continued to improve in the second 12-month period post treatment with half of the patients requiring 0 surgeries during that time.

在我們的試驗中，多數患者在接受 3107 治療後需要的手術次數減少，其中大多數患者相較治療前一年減少了 50% 至 100%。該臨床效益在治療後第二個 12 個月期間仍持續改善，其中有一半患者在該期間需要 0 次手術。

Efficacy was achieved without the vast majority of patients requiring surgery during the dosing window, a key differentiating advantage of the 3107 safety profile. Remember, in our Phase I/II trial, our protocol counted every surgery conducted after day 0. In contrast, surgeries conducted during the 12-week treatment window in the pepsemuos trial were not counted against the efficacy end point and 72% of the reported complete responders in the single-site Phase I/II trial had at least 1 surgery during the 12-week dosing window.

在給藥期間內，絕大多數患者無需接受手術即可達成療效，這是 3107 安全性特徵的一項關鍵差異化優勢。請記得，在我們的第一/二期試驗中，我們的方案將第 0 天之後進行的每一例手術都納入計算。相較之下，在 pepsemuos 試驗中，於 12 週治療期間內進行的手術不會被計入療效終點；而在單一中心的第一/二期試驗中，所報告的完全反應者中有 72% 在 12 週給藥期間內至少接受過 1 次手術。

To maintain what is referred to as minimal residual disease, or MRD, a protocol that is required for the efficacy of that product and is included in the label. Additionally, 310 offers a differentiated mechanism of action, which provides the ability to treat patients who are not served by existing therapy and thus address an unmet need in the RRP treatment landscape.

為了維持所謂的微小殘存疾病（minimal residual disease, MRD），這是一項該產品療效所必需的治療方案，並已納入其標籤中。此外，310 具備差異化的作用機轉，使其能夠治療現有療法未能涵蓋的患者，從而滿足 RRP 治療領域中尚未被滿足的需求。

Pepsemuos utilizes a gorilla adenoviral vector, and it is well established in the scientific literature that efficacy of adenoviral vectors may be impacted by preexisting neutralizing antibodies as they have been shown to limit the immune response that patients with these antibodies can generate. In addition, several immune factors relating to the papilloma microenvironment were identified by the investigators as being linked to the lack of efficacy for pepsemuos. In contrast, ad data published in Nature Communications shows that efficacy of INO-3107 is not impacted by the papaloma microenvironment. We look forward to discussing our rationale for review under accelerated approval with the FDA.

Pepsemuos 使用的是大猩猩腺病毒載體；科學文獻已充分證實，腺病毒載體的療效可能會受到既存中和抗體的影響，因為研究顯示這些抗體會限制患者所能產生的免疫反應。此外，研究者也辨識出數項與乳頭狀瘤微環境相關的免疫因素，並認為其與 pepsemuos 缺乏療效有關。相較之下，發表於《Nature Communications》的資料顯示，INO-3107 的療效不受乳頭狀瘤微環境影響。我們期待與 FDA 討論我們申請加速核准審查的理由。

And with that, I will now turn it over to Steve for a brief commercial update. Steve?

接下來，我將把時間交給 Steve，請他做一個簡短的商業面更新。Steve？

Thanks, Mike. The burden of our RP on patients is significant, and there's an urgent need for treatment options that reduce the need for repeated surgery. RRP is characterized by chronic work light growth called Papilloma to grow in the respiratory tract and can cause difficulty speaking, swallowing and breathing. Surgery is still the standard of care and patients have numerous surgeries, sometimes hundreds of surgeries in the most severe cases throughout their lifetime.

謝謝你，Mike。我們的 RP 對患者造成的負擔相當沉重，且迫切需要能降低反覆手術需求的治療選項。RRP 的特徵是在呼吸道出現稱為乳頭狀瘤（Papilloma）的慢性疣狀增生，可能導致說話、吞嚥與呼吸困難。手術仍是標準治療，患者一生中會接受多次手術；在最嚴重的病例中，甚至可能多達數百次。

Every surgery matters to patients because the risk is well established. Every surgery carries the risk of permanent damage to the vocal cords and airways and the cost of surgery can have a significant impact as well. Traveling hundreds of miles for specialized RRP care missing work and social functions while preparing for or recovering from surgery, the anxiety and frustration of impaired voice quality, making it difficult to communicate and the psychological trauma of undergoing repeated surgeries.

每一次手術對患者都很重要，因為其風險早已被充分證實。每一次手術都伴隨聲帶與氣道永久性損傷的風險，而手術費用也可能造成顯著影響。為了接受專門的 RRP 照護而長途跋涉數百英里、在準備手術或術後復原期間缺勤工作與社交活動、因聲音品質受損而產生的焦慮與挫折使溝通變得困難，以及反覆接受手術所帶來的心理創傷。

This is why we're committed to delivering on the potential of 3107 for RRP patients, and that potential has been validated in market research, which supports our belief that this product is approved to become the preferred treatment based on its efficacy, tolerability and simple treatment regimen. I shared these insights previously, but I think they bear repeating.

這正是我們致力於實現 3107 對 RRP 患者潛力的原因；而這項潛力已在市場研究中獲得驗證，支持我們的看法：一旦獲批，該產品將憑藉其療效、耐受性與簡便的治療方案成為首選治療。我之前分享過這些洞見，但我認為值得再次強調。

Physicians we engaged in market research were most interested in the fact that the vast majority of patients by 50% to 100% reduction in surgery from 3107 and for many of them, that clinical 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.

我們在市場研究中接觸的醫師最感興趣的是：絕大多數患者在使用 3107 後，手術次數可降低 50% 至 100%；且對許多患者而言，這項臨床效益會隨時間持續改善。醫師同樣對耐受性資料印象深刻；資料顯示 3107 整體而言耐受性良好，將對患者回歸日常生活的影響降到最低。

This is important considering the treatment protocol includes four doses over a relatively short period of time. And in terms of the treatment regimen itself, 3107 takes into account concern of both physicians and RRP patients. It can be administered in the physician's office without an ultra cold chain requirement. The device is simple to use and importantly, there's no requirement for surgeries to maintain minimum residual disease during the treatment window.

這點很重要，因為治療方案在相對短的時間內包含四次給藥。就治療流程本身而言，3107 也納入了醫師與 RRP 患者的顧慮。它可在醫師診間施用，且不需要超低溫冷鏈。該裝置操作簡單；更重要的是，在治療期間內不需要透過手術來維持最低殘存疾病（MRD）。

This is a key area of differentiation from Precigen's gorilla adenoviral based therapy, which, as Mike noted, requires scoping and surgery during the treatment window to maintain minimum residual disease. Precigen's data publication indicates that these surgeries are required to mitigate the effect of the immunosuppressive papilloma microenvironment to maximize the chance of clinical benefit from the product. We believe this key difference makes 3107 a more patient-centric approach to treating our RP.

這是與 Precigen 以大猩猩腺病毒為基礎的療法之間的一項關鍵差異；如 Mike 所提，該療法需要在治療期間進行內視鏡檢查與手術以維持最低殘存疾病。Precigen 發表的資料指出，這些手術是為了減輕免疫抑制性的乳頭狀瘤微環境影響，以最大化產品帶來臨床效益的機會。我們相信，這項關鍵差異使 3107 成為治療我們 RP 的更以患者為中心的方法。

I will also mention that the recently published RRP foundation position statement on the management of adults with RRP now recommends immunotherapy as first-line treatment for RRP and notes that 3107 if approved, would also be included as a first-line treatment option. I would also like to share just a few updates on our ongoing commercial launch preparations.

我也要提到，近期發表的 RRP 基金會（RRP foundation）關於成人 RRP 管理的立場聲明，現已建議將免疫治療作為 RRP 的第一線治療，並指出若 3107 獲批，也將被納入第一線治療選項。我也想分享幾項我們正在進行的商業化上市準備更新。

Over the past year, we've executed critical market research, which informed strategic choices on launch preparations for 3107. We completed targeting segmentation of product positioning work and developed our pricing strategy. On the operational front, we've selected key commercial partners, including our third-party logistics provider, specialty distributor, specialty pharmacy, patient services hub and our agency of record. We are also finalizing our go-to-market model and planning the build-out of our commercial organization. I look forward to providing further updates on our progress next quarter.

在過去一年中，我們執行了關鍵的市場研究，並據此做出 3107 上市準備的策略性選擇。我們完成了目標客群分層與產品定位工作，並制定了定價策略。在營運面，我們已選定關鍵商業合作夥伴，包括第三方物流供應商、專科經銷商、專科藥局、患者服務中心（hub）以及我們的主責代理商（agency of record）。我們也正在完成上市（go-to-market）模式的定案，並規劃商業組織的建置。我期待在下個季度提供更多進展更新。

I'll now turn it back over to Jacqui for a pipeline update.

接下來我把時間交回給 Jacqui，請她更新研發管線。

Thanks, Steve. While we remain steadfastly focused on INO-3107, in the past few quarters, we've also provided some important updates on how we're continuing to advance our DNA medicine platform. That includes promising Phase I proof-of-concept dMAb data published in Nature Medicine in October of last year, which demonstrated the technology's ability to durably and tolerably produce

謝謝你，Steve。雖然我們仍堅定聚焦於 INO-3107，但在過去幾個季度，我們也提供了一些重要更新，說明我們如何持續推進 DNA 藥物平台。其中包括去年 10 月發表於《Nature Medicine》的第一期概念驗證（proof-of-concept）dMAb 資料，顯示該技術能夠在具耐受性的情況下，於體內長期產生

monoclonal antibodies, a complex protein within the human body for up to 72-weeks without generating antidrug antibodies. Additional data presented this year has now demonstrated consistent production of dMAbs out to 96-weeks. Our pot technology builds on this research, aiming to enable additional types of complex proteins being made within the body, preclinical work evaluating the potential to expand into in vivo production of other types of therapeutic proteins, which presented at the World Federation of Hemophilia Global Forum last November, including our first data on Factor VIII production.

單株抗體——這是一種人體內的複雜蛋白——最長可達 72 週，且不會產生抗藥抗體（antidrug antibodies）。今年所呈現的額外資料，現已顯示 dMAb 的穩定產生可延續至 96 週。我們的 POT 技術在此研究基礎上更進一步，目標是讓更多類型的複雜蛋白能在體內生成；我們也正在進行臨床前研究，評估將體內（in vivo）產生擴展至其他類型治療性蛋白的潛力。這些研究於去年 11 月在世界血友病聯盟（World Federation of Hemophilia）全球論壇上發表，其中包括我們首次公布的第 VIII 因子（Factor VIII）產生資料。

We see great potential for this DPP technology to treat multiple diseases and are actively seeking partnerships to advance additional rare disease targets into clinical evaluation. We also announced an exciting opportunity to build on our research in glioblastoma, or GBM, the most common and defy brain cancer show an innovative Phase II adaptive platform trial sponsored by the Dana Farber Cancer institute.

我們看好這項 DPP 技術在治療多種疾病上的巨大潛力，並正積極尋求合作夥伴，以推進更多罕見疾病標的進入臨床評估。我們也宣布一項令人振奮的機會：在我們於膠質母細胞瘤（glioblastoma, GBM）研究的基礎上再向前推進。GBM 是最常見且最具侵襲性的腦癌；我們將參與一項由 Dana-Farber 癌症研究所主導的創新第二期適應性平台試驗。

In this trial, we will partner with Akeso to evaluate INO-50 in combination with catenilimab, their first-in-class PD-1, CTLA-4 bispecific antibody checkpoint inhibitor. The trial is planned to initiate in the second half of this year. INO-5412 is composed of INO-5401, which encodes for 3 tumor-associated antigens. And then INO-1912, which encodes for IL-12 and immune stimulants.

在此試驗中，我們將與 Akeso 合作，評估 INO-50 與其同類首創（first-in-class）的 PD-1、CTLA-4 雙特異性抗體免疫檢查點抑制劑 catenilimab 的聯合治療。該試驗預計於今年下半年啟動。INO-5412 由 INO-5401 與 INO-1912 組成；其中 INO-5401 編碼 3 種腫瘤相關抗原。而 INO-1912 則編碼 IL-12 與免疫刺激因子。

When combined with a checkpoint blockade, this targeted DNA immunotherapy has the potential to overcome the limitations for immune checkpoint therapy alone by stimulating a T cell-based immune response against the tumor antigen, and driving T cell infiltration into the GBM tumor micro environment. Combining 5412 with Akeso's novel checkpoint modality represents an important evolution of our researching GBM, building on our previous data showing the potential to improve patient outcomes and highlights our ongoing commitment to advancing innovative treatments for rare diseases with significant unmet need.

當與檢查點阻斷（checkpoint blockade）合併使用時，這種標靶 DNA 免疫療法有潛力克服單獨免疫檢查點治療的限制，方法是刺激以 T 細胞為基礎、針對腫瘤抗原的免疫反應，並促進 T 細胞浸潤至 GBM 腫瘤微環境。將 5412 與 Akeso 的新型檢查點治療模式結合，代表我們 GBM 研究的重要演進；這也建立在我們先前資料所顯示的改善患者預後潛力之上，並凸顯我們持續致力於推進針對重大未滿足需求之罕見疾病的創新療法。

We are looking forward to collaborating with these two trailblazing partners and leveraging a unique opportunity to efficiently advance another promising late-stage candidates.

我們期待與這兩家開創性的合作夥伴攜手合作，並把握一個獨特機會，以高效率推進另一項具前景的後期候選產品。

Now I'll turn it over to our CFO, Peter Kies, to group financial update. Peter?

現在我把時間交給我們的財務長 Peter Kies，為大家帶來財務更新。Peter？

Thanks, Jacqui. Today, I'd like to provide an overview of Inovio's financial results for the fourth-quarter and full year of 2025. As Jacqui noted, our primary goal is to advance INO-3107 towards approval, and we remain focused on directing resources and extending our cash runway towards a potential launch date in 2026.

謝謝你，Jacqui。今天，我想概述 Inovio 於2025年第四季及全年之財務結果。如 Jacqui 所提，我們的首要目標是推進 INO-3107 取得核准；我們仍專注於資源配置，並延長現金可支撐期間，以因應2026年潛在上市時點。

With the October PDUFA date in mind, we have further prioritized programs and resources, including recently reducing head count by approximately 15% and have focused on continuing to reduce spending to extend our cash runway. We now estimate our cash runway to take us into fourth-quarter 2026. This projection includes an operational net cash burn estimate of approximately $22 million for the first-quarter of 2026. Historically, our first-quarter operational net cash burn runs higher than other quarters.

考量到10月的 PDUFA 日期，我們進一步優先排序各項計畫與資源配置，包括近期將人力編制削減約15%，並持續致力於降低支出以延長現金可支撐期間。我們目前估計現金可支撐至2026年第四季。此預估包含2026年第一季約2,200萬美元的營運淨現金消耗估計。歷來我們第一季的營運淨現金消耗通常高於其他季度。

These cash runway projections do not include any further capital raising activities that we may undertake. We finished the fourth-quarter of 2025 with $58.5 million in cash, cash equivalents and short-term investments compared to $94.1 million as of December 31, 2024. Turning to our results for 2025. Our total operating expenses dropped from $20.5 million in the fourth-quarter of 2024 to $17.5 million in the fourth-quarter of 2025.

上述現金可支撐期間的預估未包含我們可能進行的任何進一步募資活動。我們於2025年第四季末的現金、約當現金及短期投資為5,850萬美元，相較於2024年12月31日的9,410萬美元。接著看2025年的營運結果。我們的總營運費用自2024年第四季的2,050萬美元降至2025年第四季的1,750萬美元。

Our full year operating -- operational expenses decreased 23% from $112.6 million in 2024 to $86.9 million in 2025. Inovio reported a net income for the fourth-quarter of 2025 of $3.8 million or $0.06 per share and a dilutive net loss per share of $0.26. Our total net loss for the full year of 2025 was $84.9 million or $1.81 per share basic and dilutive.

我們全年營運費用下降23%，由2024年的1億1,260萬美元降至2025年的8,690萬美元。Inovio 於2025年第四季錄得淨利380萬美元，或每股0.06美元；而稀釋後每股淨損為0.26美元。我們2025年全年淨損為8,490萬美元，基本及稀釋後每股皆為1.81美元。

The net income for the fourth-quarter 2025 was primarily driven by $21.2 million noncash gain on fair value adjustment related to our warrant liability as the fair value of the warrants fluctuates with our share price and other market inputs, the adjustment can result in significant variability in our reported net income or loss. As a reminder, you can find our full financial statements in this afternoon's press release as well as in our annual report Form 10-K filed with the SEC today.

2025年第四季的淨利主要來自與認股權證負債相關之公允價值調整所產生的2,120萬美元非現金收益；由於認股權證的公允價值會隨股價及其他市場輸入變動，該調整可能導致我們申報的淨利或淨損出現顯著波動。提醒各位，完整財務報表可見於今天下午的新聞稿，以及我們今日向美國證券交易委員會（SEC）提交的年度報告 Form 10-K。

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

以上，我把時間交回給 Jacqui。

Thanks, Peter. I'd now like to pause and open up the call to answer any questions you might have. Operator?

謝謝你，Peter。我現在先暫停一下，開放電話會議讓大家提問。接線員？

(Operator Instructions) Ted Tenthoff, Piper Sandler.

（接線員指示）Ted Tenthoff，Piper Sandler。

Great. I wanted to first start just with respect to the conversations with the FDA upcoming regarding accelerated approval. Are there any additional data that you would need to submit? Or what other factors will go into that conversation for potentially transitioning the review to accelerate our approval?

很好。我想先從即將與 FDA 就加速核准進行的討論談起。是否需要提交任何額外資料？或是還有哪些因素會納入該次討論，以便可能將審查轉為加速核准？

Thanks, Ted. Great question. So there's no new clinical data. However, we have already submitted new documentation to the FDA in the form of an assessment aid, which we submitted in February. So we are now waiting for the FDA to get back to us regarding the date of the meeting. Mike, anything you want to add to that?

謝謝你，Ted。好問題。目前不需要新的臨床資料。不過，我們已於2月以「評估輔助文件」（assessment aid）的形式向 FDA 提交了新的文件。因此我們正在等待 FDA 回覆會議日期。Mike，你要補充嗎？

Yes. The only thing I'd add, Ted, is we utilize that document to sort of reiterate what we put in our original BLA submission and really expand on our rationale for accelerated approval review. So we're -- as I mentioned, we're looking forward to having those discussions with the agency.

是的。Ted，我唯一想補充的是，我們利用該文件再次強調我們在原始 BLA 申請中所提交的內容，並進一步闡述我們支持以加速核准途徑進行審查的理由。所以——如我所提，我們期待與主管機關進行這些討論。

Jay Olson, Oppenheimer.

Jay Olson，Oppenheimer。

Thanks for providing this update and taking our questions. We had a couple of questions. I guess maybe to start with, if you do eventually gain alignment with the FDA on a priority review, how would a 6-month priority review time line impacts your ability to launch? And any launch preparations that you have underway. If you could just talk about that, that would be great. And then we have 1 follow-up, please.

謝謝你們提供最新進展並回答問題。我們有幾個問題。我想先問，如果你們最終與 FDA 就優先審查達成一致，6個月的優先審查時程會如何影響你們的上市能力？以及目前有哪些上市準備工作正在進行。若能談談這些就太好了。然後我們還有一個追問，謝謝。

Thanks, Jay. Nice to hear from you. So our focus at the moment is really on ensuring we have aligned with FDA for review under the accelerated program. We're not really focused on priority review at this stage. However, having said that, we are well advanced in our commercial preparations. And I'll ask Steve to make any comments here.

謝謝你，Jay。很高興聽到你的聲音。我們目前的重點是確保與 FDA 就加速計畫下的審查方式達成一致。在這個階段，我們並未特別聚焦於優先審查。不過話說回來，我們的商業化準備已相當成熟。我請 Steve 在這裡補充說明。

Yes. So as I mentioned in the prepared remarks, I mean, we've done a lot of market research with physicians, with patients, with payers. So we feel like we know the market opportunity quite well. We've built kind of our strategies around that. We've got our commercial partners kind of onboard or selected. And we will be prepared to get out of the gate really, really quickly, should we get approved. So I think we're doing everything that we need to be prepared and to move very quickly once the FDA makes a decision.

好的。如我在事先準備的發言中提到，我們已針對醫師、病患與支付方做了大量市場研究。因此我們覺得自己對市場機會有相當深入的理解。我們也據此建立了相關策略。我們的商業合作夥伴也已大致到位或完成遴選。一旦獲得核准，我們將能非常、非常快速地啟動上市。所以我認為我們已完成所有必要準備，並能在 FDA 做出決定後迅速推進。

Okay. Great. And then if we could follow up on the publication in Nature Communications and the. Can you just talk about any feedback that you got from KOLs and patients and how you might anticipate that feedback to translate into the uptake trajectory upon approval.

好的。很好。接著想追問一下關於發表在《Nature Communications》的論文以及——你們能否談談從關鍵意見領袖（KOL）與病患那裡收到的任何回饋，以及你們預期這些回饋在獲批後會如何轉化為採用（uptake）軌跡？

Yes. Great question, Jay. So as we mentioned on the call, we do believe that we have the preferred product profile in this space, and that's based across efficacy tolerability in a very patient-centric treatment regimen. And when we have conducted research and with research conducted by third-party providers, both patients and physicians really appreciated and preferred the product profile for 3107.

可以。好問題，Jay。如我們在電話會議中提到，我們確實相信我們在此領域具備較佳的產品特性（product profile），這是基於療效與耐受性，以及非常以病患為中心的治療方案。在我們自行進行的研究以及第三方供應商所做的研究中，病患與醫師都非常認同並偏好 3107 的產品特性。

And what was really interesting to them was the fact that the majority of patients see a significant reduction in the numbers of surgeries. So 72% of patients see a 50% to 100% reduction in the first year following treatments, and that improves up to 86% in the second year with 50% of patients in the second year, requiring no surgeries at all. So a very strong efficacy profile.

他們覺得非常有意思的一點是，多數病患的手術次數顯著下降。也就是說，72%的病患在治療後第一年手術次數可降低50%至100%；第二年可提升至86%，且第二年有50%的病患完全不需要任何手術。因此呈現非常強勁的療效特性。

With regards to tolerability, the fact that we don't require these minimal residual disease surgeries during the treatment window is very well received. And for the competitor product, over 70% of the patients required surgery during their treatment window, requiring one or more surgeries during that treatment window. Actually -- sorry, that number was actually 83%, and it was 72% of their complete responders.

在耐受性方面，我們在治療期間不需要進行這些用於維持微量殘存疾病（minimal residual disease）的手術，這點獲得非常正面的回應。而競品方面，超過70%的病患在其治療期間需要手術，也就是在該治療期間需要一次或多次手術。其實——抱歉，那個數字實際上是83%，而且在其完全反應者（complete responders）中有72%需要手術。

So as you can see, the competitive product patients receiving competitive products in their trial actually required a lot of surgery during the dosing in dose. And the fact that INO-3107 doesn't require these surgeries maintain minimal residual disease is very attractive. And then as I think Steve mentioned, it's our ability to administer 3107 in the doctor's office -- and the simple patient-centric treatment regimen, again, is very attractive to patients. Steve, anything else you want to add to that?

因此如各位所見，競品試驗中接受競品治療的病患，在給藥期間實際上需要進行相當多的手術。而 INO-3107 不需要透過這些手術來維持微量殘存疾病，這點非常具吸引力。另外，如我想 Steve 也提到的，我們能在醫師診間施打 3107——以及簡單、以病患為中心的治療方案——同樣對病患非常有吸引力。Steve，你還有什麼要補充的嗎？

No, I think you covered it. I mean the research has shown really repeatedly a lot of evidence that we have the potential to be the preferred product in this space.

不，我想你已經涵蓋到了。我的意思是，研究已經一再顯示大量證據，證明我們有潛力成為這個領域的首選產品。

[Sudan Loganatha], Stephens.

[Sudan Loganatha]，Stephens。

This is Ketan for Sudan, and congrats on wrapping up the quarter. Just a quick one. So as you engage with the third-party logistics and commercial partners ahead of launch, are you specifically using those partners to incorporate learnings from the Papsimios rollout to inform your distribution strategy site activation planning, reimbursement approach and overall launch execution for 3107?

我是代替 Sudan 的 Ketan，恭喜你們完成本季。我只有一個簡短問題。因此，當你們在上市前與第三方物流及商業合作夥伴接洽時，你們是否特別運用這些夥伴，把 Papsimios 推廣過程中的經驗教訓納入，以指導你們針對 3107 的配送策略、據點啟動規劃、給付/報銷方式以及整體上市執行？

Sure. So yes, I mean, obviously, we would -- we're watching carefully what our competitors doing and learning from that. I don't know that they're necessarily the same commercial partners that Precigen is using but they have very deep broad experience in the rare disease space. So we're learning from that as well. So I would say the more general rare disease experience, but also presses experience as well to do everything that we can to ensure that we're kind of very well prepared from a long standpoint.

當然。所以是的，我的意思是，很明顯地，我們會——我們正密切關注競爭對手在做什麼並從中學習。我不確定他們是否一定是 Precigen 所使用的同一批商業合作夥伴，但他們在罕見疾病領域擁有非常深厚且廣泛的經驗。因此我們也會從那方面學習。所以我會說，主要是更一般性的罕見疾病經驗，但也包括在新聞/媒體推廣方面的經驗，我們會盡一切所能，確保從上市角度來看我們已做好非常充分的準備。

And if I can add, there were some key differences for 3107 Paseo. We don't require any ultra cold chain also, so we don't have those logistical issues setting up an ultra-cold train. And also as we don't require these minimal residual disease surgeries during the treatment window, physicians don't have to plan for scoping and possibly doing surgery as well, which obviously makes the treatment regimen very attractive to physicians and to patients.

另外我補充一下，3107 與 Paseo 有一些關鍵差異。我們也不需要任何超低溫冷鏈，因此不會有建立超低溫運輸鏈的物流問題。此外，由於在治療期間我們不需要進行這些微小殘存病灶（MRD）手術，醫師也不必規劃內視鏡檢查並可能同時進行手術；這顯然使得該治療方案對醫師與病患都非常有吸引力。

[Roger Song], Jefferies.

[Roger Song]，Jefferies。

This is Nabil on for Roger. I had a question on the GSO partnership. If you could just kind of walk us through that biological rationale of the dual PD-1, CTLA-4 blockade. How does that sort of add on top of the T cell priming that you've shown before with 5412 and GBM?

我是代替 Roger 的 Nabil。我有一個關於 GSO 合作夥伴關係的問題。你們能否帶我們了解一下雙重 PD-1、CTLA-4 阻斷的生物學理據？這樣的機制如何在你們先前以 5412 與 GBM 所展示的 T 細胞啟動（priming）之上再加成？

Yes, great question. So in the previous study, we combined 5401 plus IL-12 plus a PD-1 inhibitor from Regeneron. And what we saw in that study was encouraging data where we saw beneficial patient outcomes linked to the immune responses against the antigens that were encoded within 5401. So by partnering with Akeso in this innovative trial, what we're hoping is that the CTL4 element in addition to the PD-1 inhibition by providing an additional pathway for checkpoint inhibition.

是的，這是個很好的問題。在先前的研究中，我們將 5401 加上 IL-12，再加上來自 Regeneron 的 PD-1 抑制劑進行合併。我們在該研究中看到令人鼓舞的數據：病患的有利結局與針對 5401 所編碼抗原的免疫反應相關。因此，透過在這項創新試驗中與 Akeso 合作，我們希望 CTLA-4 的組成在 PD-1 抑制之外，能藉由提供另一條檢查點抑制途徑。

Will allow those immune responses against the tumor-associated antigens to provide additional benefit. So we're excited to be partnering with Akeso and excited to get the study underway. Mike, anything else you would like to add?

讓這些針對腫瘤相關抗原的免疫反應帶來額外的效益。因此我們很高興能與 Akeso 合作，也很期待研究能夠啟動。Mike，你還有什麼想補充的嗎？

The only point. I mean it's well established that there is significant synergism between CTLA-4 and PD-1. So as Jacqui said, we think it will be a very nice combination to 5412?

唯一要補充的一點。我的意思是，CTLA-4 與 PD-1 之間存在顯著協同作用，這點已被充分證實。所以如 Jacqui 所說，我們認為這會是與 5412 非常好的組合。

Yes. That's exciting. A follow-up on that. I think inside historically, you guys emphasized the '06 ethaguanin metal transfer the unmethylated group. Any idea this is like early, but in terms of subgroups, like does the methylation status influence any expectations for like the immunotherapy responsiveness?

是的。這很令人振奮。我再追問一下。我想過去你們一直強調「06」——乙基鳥嘌呤甲基轉移酶（MGMT）未甲基化族群。我知道現在還早，但就亞族群而言，甲基化狀態是否會影響你們對免疫治療反應性的任何預期？

Yes. So it is a prior trial -- we saw benefits in both methylated and unmethylated groups. So we were very encouraged by that data. Sorry, Mike, you wanted to say something?

是的。在先前的試驗中——我們在甲基化與未甲基化兩組都看到了效益。因此我們對該數據感到非常鼓舞。抱歉，Mike，你想補充什麼嗎？

I was going to say exactly the same. But the INSIGHT trial is actually in the unmethylated population. So while it's very sad for the patients that will lead to a quicker readout as they have a poorer prognosis.

我正要說完全一樣的話。不過 INSIGHT 試驗其實是在未甲基化族群中進行。因此，雖然對病患而言很令人難過，但由於他們預後較差，這將帶來更快的讀出結果。

[Yi Chan], H.C. Wainright.

[Yi Chan]，H.C. Wainright。

This is Katie on for Yi. Taking a look at your pipeline, if 3107 is approved, what are your plans to move forward with 3112? Are you guys planning to reinvest internally or seek partnership for that type of program?

我是代替 Yi 的 Katie。從你們的產品線來看，如果 3107 獲得核准，你們對 3112 接下來的推進計畫是什麼？你們打算在內部再投資，還是為這類計畫尋求合作夥伴？

Yes. Great question. So for those of you who are not familiar, 3112 is our program in HPE 16 and 18 positive head and neck cancer or a parent or squamous cell carcinoma. And there, we announced a partnership with Coherus for their PD-1 inhibitor, locos, which is approved in nasopharyngeal carcinoma. We're looking to start a Phase III trial However, at the moment, the vast majority of our resources are going towards moving 3107 forward.

是的。這是個很好的問題。對於不熟悉的人來說，3112 是我們針對 HPV 16 與 18 陽性的頭頸癌，或肛門/鱗狀細胞癌的計畫。在那方面，我們已宣布與 Coherus 合作，使用其 PD-1 抑制劑 locos，該藥已在鼻咽癌獲批。我們希望啟動一項第三期試驗；然而目前，我們絕大多數資源都投入在推進 3107。

So should -- should 3107 be approved later on this year and we have sufficient financial resources available, then we'll be looking to move forward with the other candidates in our pipeline. But we're very excited by our later stage candidates, which are predominantly focused on T cell mechanisms. So 3107, 5401, 3112, are all focused on driving T cell responses, either against viral antigens or against cancer antigens.

因此——如果 3107 在今年稍晚獲得核准，且我們有足夠的財務資源可用，那麼我們將著手推進產品線中的其他候選項目。不過我們對後期階段的候選項目感到非常興奮，這些項目主要聚焦於 T 細胞機制。因此 3107、5401、3112 都著重於驅動 T 細胞反應，無論是針對病毒抗原或癌症抗原。

And then we also have our earlier stage pipeline around our depots and our DMAC candidates, where we're looking to move those candidates into the clinic through partnerships. So partnerships are going to be very important to us in terms of how we see our pipeline developing going forward.

此外，我們在更早期階段也有圍繞 depots 與 DMAC 候選項目的產品線，我們希望透過合作夥伴關係將這些候選項目推進到臨床。因此，就我們如何看待未來產品線的發展而言，合作夥伴關係對我們將非常重要。

Thank you. We have no further questions. I will now turn the call over to Jacqui Shea for closing remarks.

謝謝。我們沒有其他問題。我現在把電話交回給 Jacqui Shea 作結語。

Thank you. As we've outlined here today, our strategic focus for the months ahead is clear, advancing the BLA review for 310 and optimizing our resources to extend our cash runway towards our October 30 PDUFA date. At the same time, we'll continue driving progress across our pipeline where possible, leveraging partnership opportunities and the potential of our platform in GBM, hemophilia and other rare diseases.

謝謝。正如我們今天在此所概述的，我們未來數月的策略重點很明確：推進 310 的 BLA 審查，並最佳化資源配置，以延長我們的現金可支撐期（cash runway），直至 10 月 30 日的 PDUFA 日期。同時，我們也會在可行之處持續推動產品線進展，把握合作機會，並發揮我們平台在 GBM、血友病及其他罕見疾病上的潛力。

As I close today, I'd like to reiterate our belief that 3107 can address the unmet needs of RRP patients. Patients who have faced the risks and burdens of their disease were far too long. We're moving forward committed to making sure that every patient can find relief from repeated surgery that they deserve. Thank you for your attention, and good evening, everyone.

在我今天結束之前，我想再次重申我們的信念：3107 能夠滿足 RRP 病患尚未被滿足的需求。這些病患長期以來承受其疾病帶來的風險與負擔，時間實在太久了。我們將持續向前，致力於確保每一位病患都能獲得他們應得的、擺脫反覆手術的緩解。感謝各位的聆聽，祝各位晚安。

And thank you, ladies and gentlemen. This concludes our conference call. We thank you for your participation. You may now disconnect.

也謝謝各位女士先生。本次電話會議到此結束。感謝各位的參與。各位現在可以掛線。