GeoVax Labs Inc (GOVX) 2025 Q3 法說會逐字稿

Good afternoon, and welcome, everyone, to the GeoVax third-quarter 2025 corporate update call. My name is Sherry, and I will facilitate today's call. With me are David Dodd, Chairman and CEO; Mark Reynolds, Vice President, Chief Financial Officer; Mark Newman, PhD, Chief Scientific Officer; Kelly McKee, MD, MPH, Chief Medical Officer; and John Sharkey, PhD, Vice President, Business Development. (Operator Instructions) As a reminder, this conference is being recorded.

下午好，歡迎各位參加 GeoVax 2025 年第三季公司業績更新電話會議。我叫雪莉，今天的電話會議將由我主持。與我同行的有：董事長兼執行長大衛·多德；副總裁兼首席財務官馬克·雷諾茲；首席科學官馬克·紐曼博士；首席醫療官凱利·麥基醫學博士、公共衛生碩士；以及副總裁兼業務發展主管約翰·沙基博士。（操作說明）提醒各位，本次會議正在錄音。

Please note the following: Certain statements in this presentation may constitute forward-looking statements within the meaning of the Private Securities Litigation Reform Act. These statements are based on management's current expectations and are subject to uncertainty and changes in circumstances. Actual results may differ materially from those included in these statements due to a variety of factors, including whether GeoVax can develop and manufacture its product candidates with the desired characteristics in a timely manner and such products will be safe for human use.

請注意以下事項：本簡報中的某些陳述可能構成《私人證券訴訟改革法案》意義上的前瞻性陳述。這些聲明是基於管理層目前的預期，但會受到不確定性和情況變化的影響。由於多種因素，實際結果可能與這些聲明中包含的結果有重大差異，包括 GeoVax 能否及時開發和生產具有所需特性的候選產品，以及此類產品對人類使用是否安全。

GeoVax's vaccines will effectively prevent targeted infections in humans. GeoVax's product candidates will receive regulatory approvals necessary to be licensed and marketed. GeoVax raises required capital to complete development of its products. There is a development of competitive products that may be more effective or easier to use than GeoVax's products.

GeoVax的疫苗將有效預防人類的特定感染。GeoVax 的候選產品將獲得必要的監管批准，從而獲得許可並上市。GeoVax籌集了完成產品開發所需的資金。市面上出現了一些競爭產品，它們可能比 GeoVax 的產品更有效或更容易使用。

GeoVax will be able to enter into favorable manufacturing and distribution agreements and other factors over which GeoVax has no control. GeoVax assumes no obligation to update these forward-looking statements and does not intend to do so. More information about these factors is contained in GeoVax's filings with the Securities and Exchange Commission, including those set forth at Risk Factors in GeoVax's Form 10-K.

GeoVax 將能夠簽訂有利的生產和分銷協議，以及其他 GeoVax 無法控制的因素。GeoVax不承擔更新這些前瞻性聲明的義務，也不打算這樣做。有關這些因素的更多信息，請參閱 GeoVax 向美國證券交易委員會提交的文件，包括 GeoVax 10-K 表格中「風險因素」部分列出的內容。

It is now my pleasure to introduce the Chairman and CEO of GeoVax, David Dodd. Please go ahead.

現在我很榮幸地向大家介紹 GeoVax 的董事長兼執行長大衛‧多德。請繼續。

Thank you. Welcome to the third-quarter 2025 GeoVax corporate update. Following my comments, Mark Reynolds, our CFO, will provide an update of our financials, and then we will address any questions that you may have.

謝謝。歡迎閱讀 GeoVax 2025 年第三季公司最新動態。在我發言之後，我們的財務長馬克雷諾茲將介紹我們的財務狀況，然後我們將回答您可能提出的任何問題。

We remain confident in the continued progress and compelling outlook for our portfolio of GEO-MVA, GEO-CM04S1, Gedeptin and the game-changing MVA vaccine manufacturing process. Each of our product development candidates address critically important unmet health care needs, providing opportunities for expedited registration paths and strong opportunities to commercialize differentiated solutions supporting patient needs worldwide.

我們對 GEO-MVA、GEO-CM04S1、Gedeptin 以及顛覆性的 MVA 疫苗生產流程組合的持續進展和令人振奮的前景仍然充滿信心。我們的每個產品開發候選產品都旨在解決至關重要的未滿足的醫療保健需求，從而為加快註冊途徑和實現差異化解決方案的商業化提供強有力的機會，以滿足全球患者的需求。

We also anticipate that the advanced MVA manufacturing process will provide a game-changing advantage in production of MVA-based vaccines and therapies. We're experiencing increased partnering and collaboration interest from established industry players as well as increased interest from nondilutive funding organizations, including stakeholders addressing various areas of worldwide vaccine needs.

我們也預計，先進的 MVA 製造流程將為基於 MVA 的疫苗和療法的生產帶來顛覆性的優勢。我們發現，來自成熟產業參與者的合作與協作興趣日益濃厚，來自非稀釋性融資機構（包括致力於解決全球疫苗需求各領域的利害關係人）的興趣也日益濃厚。

In June, we announced the receipt of guidance from the European Medicines Agency, referred to as the EMA, providing an expedited development path for GEO-MVA, our vaccine candidate against Mpox and Smallpox. This is most encouraging news in that it provides the potential for GeoVax to achieve marketing authorization and revenue generation sooner, allowing us to bypass Phase 1b and Phase 2 clinical trials and proceed directly to a Phase 3 immuno-bridging trial.

6 月，我們宣布收到歐洲藥品管理局（簡稱 EMA）的指導意見，為我們的抗痘和天花候選疫苗 GEO-MVA 提供了一條加快開發的道路。這是最令人鼓舞的消息，因為它使 GeoVax 有可能更快地獲得上市許可並產生收入，使我們能夠跳過 1b 期和 2 期臨床試驗，直接進行 3 期免疫橋接試驗。

As a result of this news, we're experiencing increased interest and dialogue with various industry colleagues and stakeholders regarding potential partnering, collaboration and funding. Relative to GEO-MVA, we have initiated the fill/finish of clinical batch vaccine material. We anticipate having vaccine available for clinical evaluation early next year. We're pleased to note that in addition to product in support of our clinical evaluation, we plan to produce additional product in support of potential use in conjunction with various stakeholder discussions that are underway.

由於這一消息，我們與各行業同行和利益相關者就潛在的合作、協作和資金問題展開了更多討論和對話。針對 GEO-MVA，我們已經啟動了臨床批次疫苗材料的填充/完成工作。我們預計明年年初即可提供疫苗進行臨床評估。我們很高興地註意到，除了用於支持臨床評估的產品外，我們還計劃生產更多產品，以支持與各利益相關方正在進行的討論中可能使用的產品。

We believe that GEO-MVA provides the potential to end the current monopoly of MVA vaccine supply, expanding the global supply of this critically needed vaccine, addressing both the needs resulting from epidemic outbreaks as well as the various stockpile opportunities worldwide.

我們相信，GEO-MVA 有潛力打破目前 MVA 疫苗供應的壟斷局面，擴大這種急需疫苗的全球供應，既能滿足疫情爆發的需求，又能滿足世界各地各種儲備機會。

Significant government interest exists relative to US-based supply chains versus the current overdependence on non-US suppliers. The strong sentiment in favor of such onshoring initiatives is a major national legislative focus and interest.

與目前過度依賴非美國供應商相比，美國政府對美國本土供應鏈展現出濃厚的興趣。支持此類本土化措施的強烈呼聲是國家立法機構關注的重點和利益所在。

We remain in active discussions and briefings with various stakeholders, including the White House, Congressional Representatives, HHS, WHO, the International Vaccine Institute, the Africa CDC and others regarding our progress relative to cGMP clinical inventory of GEO-MVA.

我們與包括白宮、國會代表、美國衛生與公眾服務部、世界衛生組織、國際疫苗研究所、非洲疾病預防控制中心等在內的各利益相關方保持著積極的討論和簡報，討論我們在 GEO-MVA 的 cGMP 臨床庫存方面取得的進展。

In fact, this was the subject of numerous discussions during our recent series of meetings in Europe in conjunction with the World Vaccine Congress Europe, BIO-Europe and individual meetings held in Geneva and elsewhere.

事實上，這正是我們近期在歐洲舉行的一系列會議的主題，這些會議包括與歐洲世界疫苗大會、歐洲生物技術大會以及在日內瓦和其他地方舉行的個別會議。

Over the remainder of 2025, we look forward to providing additional updates on our progress with this vaccine. GEO-CM04S1, our multi-antigen vaccine against COVID-19 is increasingly recognized as a critically needed vaccine for use among the over 40 million immunocompromised adults in the US as well as the over 400 million worldwide.

在 2025 年剩餘的時間裡，我們期待著向大家提供更多關於我們疫苗研發進展的最新資訊。GEO-CM04S1 是我們針對 COVID-19 的多抗原疫苗，它越來越被認為是美國 4000 多萬免疫功能低下的成年人以及全球 4 億多免疫功能低下的成年人急需的疫苗。

Based on the clinical data results thus far, we believe that CM04S1 provides potential for demonstrating a more robust immune response against emerging variants, improved durability versus the first-generation single antigen COVID-19 vaccine and especially in addressing the immune protection among those patients with compromised immune systems.

根據目前為止的臨床數據結果，我們認為 CM04S1 有潛力對新出現的變異株產生更強大的免疫反應，與第一代單抗原 COVID-19 疫苗相比具有更強的持久性，尤其是在免疫系統受損的患者中提供免疫保護方面。

Our current CM04S1 studies are progressing, especially our focus on continued enrollment of severely immunocompromised patients with blood cancers who have received cell transplants and towards completion of the investigator-initiated Phase 2 trial among chronic lymphocytic leukemia patients.

我們目前的 CM04S1 研究正在取得進展，特別是我們繼續專注於招募接受過細胞移植的嚴重免疫功能低下的血液癌症患者，並朝著完成研究者發起的針對慢性淋巴細胞白血病患者的 2 期試驗的目標邁進。

Both the hematologic cell therapy patients and the CLL patients represent the highest risk groups in need of reducing the risk of severe infection, hospitalization and the risk of death resulting from COVID-19 infection.

血液細胞治療患者和慢性淋巴細胞白血病 (CLL) 患者都是風險最高的群體，需要降低因 COVID-19 感染而導致的嚴重感染、住院和死亡風險。

For these individuals, the pandemic continues. Demonstrating the critically important value of CM04S1 among such immune-compromised patients remains our focus for differentiation from the first-generation COVID-19 vaccines.

對這些人來說，疫情仍在持續。證明 CM04S1 在免疫功能低下患者中的關鍵價值仍然是我們與第一代 COVID-19 疫苗區分開來的重點。

The medical need for a vaccine such as CM04S1 remains substantial for those with medical conditions that render their immune systems inadequate in responding to the first-generation vaccine. It's noteworthy that just recently, the Infectious Disease Society of America, known as IDSA, issued updated guidelines regarding COVID-19 vaccine among immunocompromised patients. These critically important guidelines are well exceedingly well with our development of CM04S1.

對於那些因疾病導致免疫系統無法對第一代疫苗做出反應的人來說，像 CM04S1 這樣的疫苗的醫療需求仍然很大。值得注意的是，就在不久前，美國傳染病學會（IDSA）發布了關於免疫功能低下患者接種 COVID-19 疫苗的最新指南。這些至關重要的指導原則與我們 CM04S1 的發展非常契合。

During third quarter, multiple presentations of clinical results for CM04S1 were provided at the International Workshop on Chronic Lymphocytic Leukemia, the World Vaccine Congress Europe and the European Society of Clinical Microbiology and Infectious Disease.

第三季度，CM04S1 在國際慢性淋巴球白血病研討會、歐洲世界疫苗大會和歐洲臨床微生物學和傳染病學會上進行了許多臨床結果展示。

Each of these presentations resulted in additional and expanded discussions regarding potential partnering and collaborative developments.

每一次報告都引發了關於潛在合作與協作發展的進一步討論。

Let me point out, while such discussions tend to follow a somewhat tedious due diligence process, we are encouraged by the continued interest in CM04S1 as the leading multi-antigen COVID-19 vaccine in clinical development.

我想指出的是，雖然這類討論往往需要經過一些繁瑣的盡職調查過程，但我們對 CM04S1 作為臨床開發中領先的多抗原 COVID-19 疫苗持續受到關注感到鼓舞。

Relative to our plans for a Phase 2 Gedeptin trial in head and neck cancer, the primary determinant of the timing to initiate the Phase 2 trial is the completion of necessary product manufacturing. That is underway, along with the continued clinical operations plans and the necessary regulatory aspects.

就我們針對頭頸癌所進行的 Gedeptin 2 期試驗計畫而言，啟動 2 期試驗時間的主要決定因素是必要的產品生產完成情況。相關工作正在進行中，同時也有持續的臨床營運計畫和必要的監管方面工作。

Earlier this year, Dr. Marc Pipas presented at the AACR meeting in Chicago, reviewing the clinical results thus far and our plans for the Phase 2 study. Peer-reviewed publication of this work is forthcoming in JCO Oncology Advances, so be on the outlook for this.

今年早些時候，Marc Pipas 博士在芝加哥舉行的 AACR 會議上發表了演講，回顧了迄今為止的臨床結果以及我們對 2 期研究的計劃。這項研究成果將在 JCO Oncology Advances 上發表，敬請期待。

Following the impressive results of the KEYNOTE-689 study presented at ASCO, we have modified the Gedeptin Phase 2 study protocol, changing the target population to first-line therapy, mimicking KEYNOTE-689 trials historical control. As such, our focus will be on evaluating neoadjuvant Gedeptin and pembro, offering meaningful efficacy and tolerability in patients with primary squamous cell carcinoma head and neck, who are being considered for surgical resection with curative intent.

在 ASCO 上公佈了 KEYNOTE-689 研究的令人印象深刻的結果之後，我們修改了 Gedeptin 2 期研究方案，將目標人群改為一線治療，以模擬 KEYNOTE-689 試驗的歷史對照。因此，我們將專注於評估新輔助治療藥物 Gedeptin 和 pembro，以期為接受根治性手術切除的原發性頭頸部鱗狀細胞癌患者提供有意義的療效和耐受性。

Our primary endpoint will be major pathological response. We believe that Gedeptin has the potential to address multiple solid tumors, especially via combination therapy, providing significant value long term.

我們的主要終點指標將是主要病理反應。我們相信，Gedeptin 有潛力治療多種實體瘤，特別是透過聯合療法，從而提供長期的顯著價值。

We also plan additional studies of Gedeptin addressing other solid tumors beyond head and neck cancer. In addition, we are engaging in various discussions related to potential collaborations in the long-term development and commercialization of Gedeptin.

我們也計劃進行更多關於 Gedeptin 治療頭頸癌以外其他實體瘤的研究。此外，我們正在就 Gedeptin 的長期開發和商業化方面的潛在合作進行各種討論。

Overall, our goal is to successfully develop innovative cancer therapies and infectious disease vaccines, addressing critically important unmet medical needs, pursuing initial indications that support expedited registration pathways. We anticipate business partnerships and collaborations in support of worldwide development, commercialization and distribution.

總而言之，我們的目標是成功開發創新的癌症療法和傳染病疫苗，以滿足至關重要的未滿足醫療需求，並尋求支持快速註冊途徑的初步適應症。我們期待透過商業夥伴關係和合作，支持全球範圍內的開發、商業化和分銷。

Our priorities and anticipated milestones for 2025 through 2026 remain focused on advancing GEO-MVA to clinical evaluation, advancing GEO-CM04S1 for immune-compromised populations, advancing the progress of the advanced MVA manufacturing process and our focus on oncology, specifically related to Gedeptin is a major priority for the future of GeoVax.

2025 年至 2026 年，我們的優先事項和預期里程碑仍然集中在推進 GEO-MVA 進入臨床評估階段、推進 GEO-CM04S1 用於免疫功能低下人群、推進先進 MVA 製造工藝的進展，以及我們對腫瘤學的關注，特別是與 Gedeptin 相關的腫瘤學，是 GeoVax 未來發展的主要優先事項。

We have high expectations for the potential broad utilization of Gedeptin against various solid tumors, especially in combination with immune checkpoint inhibitors. We also are focused on progressing various partnering and collaboration discussions in support of these developments with the potential to accelerate the pace of these programs. We're confident that we're on a course that will build significant shareholder and stakeholder value while delivering critically important differentiated products to improve lives worldwide.

我們對 Gedeptin 在對抗各種實體瘤方面的潛在廣泛應用寄予厚望，尤其是在與免疫檢查點抑制劑聯合使用時。我們也致力於推動各種合作與夥伴關係討論，以支持這些發展，並有可能加快這些專案的進度。我們有信心，我們正走在一條能夠為股東和利害關係人創造巨大價值，同時提供至關重要的差異化產品以改善全球人民生活的道路上。

Now I'd like to turn the presentation over to Mark Reynolds, GeoVax Chief Financial Officer, for a review of our recent results and financial status. Mark?

現在，我想把演講交給 GeoVax 財務長 Mark Reynolds，讓他回顧我們最近的表現和財務狀況。標記？

Thank you, David. And the details of our third quarter financial results are summarized in today's press release. I'll start the review with our income statement. During the nine months ended September 30, 2025, we reported revenues of $2.5 million versus $3.1 million in 2024. This relates to the BARDA Project NextGen contract that began in June 2024.

謝謝你，大衛。我們第三季財務業績的詳細情況已在今天的新聞稿中進行了概述。我將首先從我們的損益表開始進行回顧。截至 2025 年 9 月 30 日的九個月期間，我們的收入為 250 萬美元，而 2024 年的收入為 310 萬美元。這與 BARDA 的「下一代計畫」合約有關，該計畫於 2024 年 6 月開始。

And as we previously discussed in our Q1 earnings call this year, in April, the contract was terminated along with other Project NextGen funded contracts as part of the government's efficiency program, so there were no contract revenues reported during Q3.

正如我們在今年 4 月第一季財報電話會議上討論的那樣，該合約與其他由「下一代專案」資助的合約一起，作為政府效率計劃的一部分而被終止，因此第三季度沒有報告任何合約收入。

Research and development expense for the quarter was $5 million versus $7.4 million in 2024. For the nine-month period, R&D expense was $15.1 million versus $16.1 million in 2024.

本季研發費用為 500 萬美元，而 2024 年為 740 萬美元。前九個月的研發費用為 1,510 萬美元，而 2024 年則為 1,610 萬美元。

The decrease during 2025 is primarily related to discontinued costs associated with the termination of the BARDA contract as well as lower costs for the CM04S1 clinical trials and manufacturing costs associated with the CM04S1 and Gedeptin programs. These lower costs were partially offset by higher personnel and consulting costs and manufacturing costs associated with the GEO MVA development program in preparation for initiating clinical trials in 2026.

2025 年的下降主要與終止 BARDA 合約相關的成本減少，以及 CM04S1 臨床試驗成本降低和與 CM04S1 和 Gedeptin 計畫相關的生產成本降低有關。這些較低的成本被與 GEO MVA 開發計劃相關的較高人員和諮詢成本以及製造成本部分抵消，該計劃旨在為 2026 年啟動臨床試驗做準備。

General and administrative expense was $1.3 million for the third quarter of '25 versus $1.2 million in '24. For the nine-month period, G&A expense was $4.6 million versus $3.8 million in '24. The overall increase during 2025 is associated with higher personnel costs, investor relations consulting and other programmatic expenses and stock-based compensation expense.

2025 年第三季一般及行政費用為 130 萬美元，而 2024 年為 120 萬美元。前九個月的一般及行政費用為 460 萬美元，而 2024 年為 380 萬美元。2025 年的整體成長與人員成本、投資者關係諮詢和其他項目費用以及股票選擇權補償費用的增加有關。

Other income expense was $151,000 for the year-to-date period in '25 as compared to $70,000 in '24, primarily reflecting higher interest income. So overall net loss for the quarter was $6.3 million versus $5.8 million in '24 and $17 million for the year-to-date period versus $16.7 million in '24.

2025 年同期其他收入支出為 151,000 美元，而 2024 年同期為 70,000 美元，主要反映了利息收入的增加。因此，本季淨虧損總額為 630 萬美元，而 2024 年同期為 580 萬美元；年初至今淨虧損總額為 1,700 萬美元，而 2024 年同期為 1,670 萬美元。

Turning now to the balance sheet. Our cash balances at September 30 were $5 million as compared to $5.5 million at December 31, '24, reflective of $16.5 million used in operating activities, offset by $16 million in financing transactions.

現在來看資產負債表。截至 2024 年 9 月 30 日，我們的現金餘額為 500 萬美元，而截至 2024 年 12 月 31 日為 550 萬美元，這反映了經營活動中使用的 1,650 萬美元，以及融資交易中使用的 1,600 萬美元。

Our outstanding common shares currently stand at $27.7 million. Supporting our clinical programs for the priority programs at CM04S1, GEO-MVA and Gedeptin will be the most significant use of our cash for the foreseeable future.

我們目前已發行普通股的市值為2,770萬美元。在可預見的未來，我們資金最重要的用途將是支持 CM04S1、GEO-MVA 和 Gedeptin 等優先項目的臨床項目。

We continue to explore various strategies to fund these programs through several valuation inflection points and also to extend our cash runway. These could include strategic partnerships, nondilutive funding or additional offerings of our common stock.

我們將繼續探索各種策略，透過幾個估值拐點為這些項目提供資金，並延長我們的現金儲備。這些措施可能包括策略合作、非稀釋性融資或增發普通股。

And I'll be happy to answer any questions during the Q&A, and I'll now turn the call back to David.

我很樂意在問答環節回答任何問題，現在我會把電話轉回給大衛。

Thank you, Mark. My colleagues and I will now answer your questions. Joining us for the Q&A session are Dr. Mark Newman, Kelly McKee and John Sharkey, our Chief Scientific Officer, Chief Medical Officer and Vice President of Business Development, respectively.

謝謝你，馬克。現在我和我的同事將回答你們的問題。參加問答環節的有首席科學官馬克紐曼博士、首席醫療官凱利麥基和業務發展副總裁約翰沙基。

I'll now turn the call over to the operator for instructions on the question-and-answer period.

現在我將把電話轉交給接線員，聽取問答環節的相關指示。

(Operator Instructions)

（操作說明）

Jonathan Aschoff, ROTH Capital Partners.

喬納森·阿肖夫，ROTH Capital Partners。

I was kind of curious, can you envision any kind of scenario, an outbreak type of scenario that would get MVA into the hands of governments? Is there anything that you can think of that would make that go commercial at least temporarily way before you would do any sort of clinical trials with it?

我有點好奇，您能否設想一下，在什麼情況下，例如疫情爆發之類的，會導致《機動車保險法》（MVA）落入政府手中？你能想到什麼辦法能讓這項技術至少在進行任何臨床試驗之前就暫時商業化嗎？

This is David, Jonathan. I wouldn't anticipate that prior to any clinical evaluation that such a situation would occur. We do believe there may be an opportunity as well as a significant need for emergency use licensing, which would come through WHO based on certain situations occurring. And some of those types of discussions were part of our recent trip in Europe that we had with WHO and other parties.

這是大衛，喬納森。我預計在進行任何臨床評估之前，不會發生這種情況。我們認為，在某些特定情況下，可能會出現緊急使用許可的機會和重大需求，而這可以透過世界衛生組織來實現。我們最近在歐洲與世衛組織和其他各方進行的討論中，也包含了其中一些類型的討論。

Okay. I think that's really all that I had. The Q will come out soon, yes.

好的。我想這就是我全部的家當了。Q系列很快就會發布了，沒錯。

Yes.

是的。

The 10-Q.

10-Q。

Yeah, the Q (technical difficulty)

是的，Q（技術難題）

Yeah, I think came out at 4.

是的，我想是4點出來的。

Robert LeBoyer, NOBLE Capital Markets.

Robert LeBoyer，NOBLE Capital Markets。

Congratulations on all the progress you've been making. I know it's probably a little early to talk about the collaborations specifically. But on the broad strategic level, is there anything that you can tell us about what you're thinking in terms of the collaborations or partnerships or anything like that, that would be helpful in determining what the prospects are for kind of business combination or partnership?

恭喜你所取得的所有進步。我知道現在談論具體的合作可能還為時過早。但從宏觀策略層面來看，您能否透露一些關於合作、夥伴關係或其他類似方面的想法，以便我們確定某種商業合併或合作的前景？

Sure, Robert. This is David. We hold worldwide rights for all of our product assets. And our plan and our focus is to register broadly on a global basis. It doesn't mean every single country, as you know, but broadly to register on it.

當然可以，羅伯特。這是大衛。我們擁有所有產品資產的全球權利。我們的計劃和重點是在全球廣泛註冊。這並不指每個國家都要註冊，如你所知，而是指大致上要在上面註冊。

And our initial thinking is that we would be able to handle North America, which would be the US and Canada, but I would also underscore that we'll always listen to any proposal that a potential partner has. We are quite active in attending various conferences as we just did, both World Vaccine Congress Europe as well as BIO-Europe. BIO-Europe is largely a partnering-oriented conference. We attend that every fall as well as in the spring as well as obviously US-based similar types of conferences.

我們最初的想法是，我們可以負責北美市場，也就是美國和加拿大，但我也要強調，我們總是會認真聽取潛在合作夥伴的任何建議。我們非常積極地參加各種會議，就像我們剛參加的歐洲世界疫苗大會和歐洲生物技術大會一樣。BIO-Europe 主要是以合作為導向的會議。我們每年秋季和春季都會參加，當然也會參加美國境內類似的會議。

So increasingly, our discussions related to potential partnering or collaboration, which would entail involvement of a partner as we develop it for a particular region, and you can sort of think through how certain rights would be distributed if someone was heavily focused in a certain region, the Pacific region, then they might be assisting us in the development process for their regulatory process, et cetera. So all of those types of concepts are actively discussed in meetings that we continue to have and have been having. And we're open to whatever makes sense from a win-win and from the basis of value for our shareholders as well as the stakeholders who are out there.

因此，我們越來越多地討論潛在的合作或夥伴關係，這意味著在為特定地區開發產品時需要合作夥伴的參與。你可以想像一下，如果有人非常專注於某個地區，例如太平洋地區，那麼某些權利將如何分配，他們可能會協助我們進行其監管流程的開發等等。因此，所有這些類型的概念都在我們持續舉行的會議中積極討論。我們對任何能夠實現雙贏，並為我們的股東和所有利害關係人創造價值的方案都持開放態度。

Jim Molloy, Alliance Global Partners.

吉姆·莫洛伊，Alliance Global Partners。

This is Laura Suriel on for Jim Molloy. So for GEO-MVA, can you just talk a bit more about the collaboration you have in place with the University of Queensland and UniQuest for the needle-free administration method that you have for this vaccine? And also any research or manufacturing plans that you have in place here as well?

這裡是勞拉·蘇裡爾，替吉姆·莫洛伊為您報道。那麼對於 GEO-MVA，您能否再詳細談談您與昆士蘭大學和 UniQuest 就該疫苗的無針注射方法開展的合作？另外，你們這裡也有任何研發或生產計畫嗎？

So we announced not too long ago that we were doing an evaluation in conjunction with the technology out of out of Vaxxas. And we believe it's very important and in fact, critically important for certain regions of the world to look at nontraditional delivery methods. And as you know, Vaxxas is a leader in the area of microarray patches. There's someone we've known for several years as well as other very good players in those delivery areas. And so we're evaluating it to see what the feasibility is relative to GEO-MVA.

所以不久前我們宣布，我們將結合Vaxxas公司的技術來進行評估。我們認為，對於世界上的某些地區來說，研究非傳統交付方式非常重要，事實上，更是至關重要。如您所知，Vaxxas 是微陣列貼片領域的領導者。我們認識其中一位好幾年了，還有其他一些在配送區非常優秀的球員。因此，我們正在評估它相對於 GEO-MVA 的可行性。

And as information comes actively -- in evaluation now, as information comes forward, we will make appropriate announcements of that. And so that's what we're doing within that realm of it. You asked a question, I think, about manufacturing. What was that? I didn't quite get it, please.

隨著資訊的不斷湧現——目前正在進行評估，隨著資訊的不斷湧現，我們將發布相應的公告。所以，這就是我們在這個領域內所做的工作。我想，你問的是一個關於製造業的問題。那是什麼？我沒完全明白，謝謝。

Just the manufacturing that you might have for this particular program for GEO-MVA?

您指的是針對 GEO-MVA 這個特定項目可能需要的製造服務嗎？

GEO-MVA, I'm going to ask our executive lead for our GEO-MVA program, John Sharkey to address that. John?

GEO-MVA，我將請我們 GEO-MVA 專案的執行負責人 John Sharkey 來談談這個問題。約翰？

So in regards to our manufacturing, as we've explained before, our lead here is to manufacture on the CEF platform, Chicken Embryo Fibroblast. That is the fastest pathway to registration and EMA has understood this.

所以，就我們的生產而言，正如我們之前解釋過的，我們的主要目標是在 CEF 平台（雞胚成纖維細胞）上進行生產。這是最快的註冊途徑，EMA也明白這一點。

Our partner is, as we do with all our programs, we use CDMOs. And so we're partnered with Oxford Biomedica in the UK. We are -- as David mentioned in the presentation, we're in the process of packaging our clinical supplies, and we are in active discussions with OXB to how we can expand the supply out of their facility as well in discussions with other potential manufacturers to add additional supply as we move -- when we move forward to commercialization.

和我們所有的專案一樣，我們的合作夥伴也是CDMO。因此，我們與英國的牛津生物醫學公司建立了合作關係。正如 David 在演講中提到的，我們正在對臨床用品進行包裝，並且正在與 OXB 積極討論如何擴大其工廠的供應，同時也在與其他潛在的製造商進行討論，以便在我們推進商業化進程時增加額外的供應。

(Operator Instructions) John Vandermosten, Zacks.

（操作說明）John Vandermosten，Zacks。

So you guys are working with CEPI, Africa CDC, WHO and others. What regions of the world are looking most supportive for your vaccine programs? And then what are their pathogens of greatest concern?

所以你們正在與流行病防範創新聯盟（CEPI）、非洲疾管中心、世界衛生組織（WHO）等機構合作。世界上哪些地區對你們的疫苗接種計畫最為支持？那麼，他們最擔心的病原體是什麼呢？

I think clearly -- and John, that from the perspective of GEO-MVA, it's obviously in the Southern Hemisphere, where you see endemic outbreaks. But then we're also seeing increasingly reports of Mpox and the new strain Mpox becoming evident not only in the US but throughout Europe. But certainly, the concentration is in the Southern Hemisphere. And there's a significant interest from parties that relate to that.

我認為很明顯——約翰，從 GEO-MVA 的角度來看，很明顯，疫情主要發生在南半球，那裡是地方性疫情爆發的地方。但同時，我們也看到越來越多的報導指出，痘病毒和新株痘病毒不僅在美國，而且在整個歐洲都開始出現。但可以肯定的是，這些集中區域位於南半球。對此，相關各方表現出了濃厚的興趣。

I mean we keep being encouraged and told by WHO leaders that this is not going away. It's going to continue to evolve. It's not going to get any better and that they really are in need of our supply contribution as well as the eventual shift to our AGE1, our suspension cell line, continuous manufacturing process for that. So I think from that standpoint, that's where that one is heavily concentrated, which sort of is intuitive. But it's on a broader basis. It's not just the stockpile needs, it will eventually also include the response in a more timely manner to endemic needs also. So we believe that.

我的意思是，世界衛生組織的領導人不斷鼓勵我們，並告訴我們，疫情不會消失。它也會繼續發展演變。情況不會好轉，他們確實需要我們的供應支持，以及最終轉向我們的 AGE1（懸浮細胞生產線）連續生產流程。所以我覺得從這個角度來看，這就是它高度集中的地方，這在某種程度上也是符合直覺的。但這是在更廣泛的層面上。這不僅僅是儲備需求，最終還將包括更及時地應對地方性需求。所以我們相信這一點。

When it comes to our CM04S1, clearly, the most significant need are among those populations who have inadequate -- they have medical conditions that have rendered their immune systems, basically inability to appropriately respond to antibody stimulation. And for these people, as I mentioned, the pandemic continues. I mean, these 40-plus million adults in the United States, the estimated 400 million worldwide who have various medical conditions, blood cancers, kidney disease, diabetes, multiple sclerosis, lupus, et cetera, it goes on and on. These are individuals that their risk is not so much, for instance, to die of the blood cancer that they have or to be hospitalized from, it's more from an infection. That's where they're risk.

就我們的 CM04S1 而言，顯然，最迫切的需求群體是那些免疫系統不足的人群——他們患有疾病，導致他們的免疫系統基本上無法對抗體刺激做出適當的反應。正如我之前提到的，對這些人來說，疫情仍在持續。我的意思是，美國有超過 4000 萬成年人患有各種疾病，包括血液癌症、腎臟病、糖尿病、多發性硬化症、紅斑狼瘡等等，全球估計有 4 億人患有這些疾病，不勝枚舉。例如，這些人面臨的風險並非死於他們所患的血癌或因此住院，而是死於感染。這就是他們面臨的風險。

And so that's where we see a broad interest for those parties that are caring for individuals who have such medical conditions. These medical practitioners, these medical health care groups, they are very interested in what our vaccine has the capability or potential to do and how can we move it faster. That's what we're always asked. And the answer is as a pre-revenue company, it's all about the balance sheet.

因此，我們看到，那些照顧患有此類疾病的個體的各方對此有著廣泛的興趣。這些醫療從業人員、這些醫療保健團體，他們非常關注我們的疫苗具有什麼能力或潛力，以及我們如何更快地推廣它。我們總是被問到這個問題。答案是，對於一家尚未產生收入的公司來說，一切都取決於資產負債表。

The stronger our balance sheet is, the faster we can move something forward. Obviously, we're all looking forward to the Phase 2 trial with Gedeptin. And as we go forward with the implementation of that, evaluating Gedeptin along with pembro in first-line therapy, you're following mimicking the KEYNOTE-689 trial. So there's a lot of interest in that related to any parties that are following solid tumor cancers.

資產負債表越穩健，我們就能越快推進專案。顯然，我們都非常期待 Gedeptin 的第二期臨床試驗。隨著我們推進該方案的實施，評估 Gedeptin 與 pembro 聯合一線治療的效果，我們正在效仿 KEYNOTE-689 試驗。因此，對於關注實體腫瘤癌症的任何一方來說，這都引起了極大的興趣。

So we get a question on all of these at various meetings. I would say right now, we have many more questions and interest because of the sense of urgency related to GEO-MVA. We spent a lot of time addressing that as well as opportunities with Gedeptin.

所以我們在各種會議上都會被問到這些問題。我認為，目前由於 GEO-MVA 的緊迫性，我們有更多的問題和興趣。我們花了很多時間來解決這個問題，以及與 Gedeptin 合作的機會。

Okay. And my next question is on Gedeptin actually and the use of -- you mentioned that you're going to have it in combination with pembro. Do you think by the time this is approved, there'll be a biosimilar version of that available? And do you think that will help adoption?

好的。我的下一個問題實際上是關於 Gedeptin 的，以及它的用途——您提到您將把它與 pembro 聯合使用。你認為等到這項技術獲得批准時，會有相應的生物相似藥上市嗎？你認為這對收養有幫助嗎？

I would say I really don't know because we may very well continue to develop Gedeptin across various immune checkpoint inhibitors. We have other players who have checkpoint inhibitors are interested in what we're doing. Obviously, we don't have the resources to do a blanket testing across all immune checkpoint inhibitors, but we do have potential interest, and that may evolve into some collaborative development opportunities.

我真的不知道，因為我們很可能會繼續開發 Gedeptin 作為各種免疫檢查點抑制劑。還有其他一些擁有檢查點抑制劑的玩家對我們正在做的事情很感興趣。顯然，我們沒有資源對所有免疫檢查點抑制劑進行全面測試，但我們對此有潛在興趣，這可能會發展成為一些合作開發的機會。

We've had some discussions, but I would be -- it would be incorrect for me to suggest that we're actively in discussions that are going to, within a reasonable time period, expand it to other ICIs.

我們已經進行了一些討論，但是，如果我說我們正在積極討論，並且將在合理的時間範圍內將其擴展到其他ICI，那將是不正確的。

We have interest that's been expressed. We've had a few discussions, and we're certainly open to that and would encourage such discussions. But we'll just see how those discussions continue to evolve.

我們已經收到了一些表達的興趣。我們已經進行過幾次討論，我們當然對此持開放態度，並鼓勵進行此類討論。但我們將拭目以待，看看這些討論將如何繼續發展。

This concludes our question-and-answer session. I would like to turn the conference back over to David Dodd for any closing remarks.

我們的問答環節到此結束。我謹將會議交還給大衛·多德，請他作總結發言。

Well, thank you, everyone, for participating in today's update. We really appreciate your interest, and we look forward to ongoing interactions. As always, I wish to acknowledge and thank the GeoVax Board of Directors and advisers -- certainly, our GeoVax staff and the many other parties who contribute toward our success.

感謝大家參與今天的更新。我們非常感謝您的關注，並期待與您繼續交流。一如既往，我要感謝 GeoVax 董事會和顧問——當然，還有我們的 GeoVax 員工以及為我們的成功做出貢獻的許多其他各方。

We're committed to providing meaningful career development opportunities for highly competitive, quality-oriented individuals seeking to disrupt the current paradigm of cancer therapies and infectious disease vaccines. We welcome any and continued inquiries about opportunities at GeoVax. We're a small company, so we received many more inquiries than we have availability for, but we thank you for your interest.

我們致力於為那些具有高度競爭力、注重品質、渴望顛覆當前癌症療法和傳染病疫苗模式的人才提供有意義的職業發展機會。我們歡迎您隨時諮詢有關 GeoVax 的工作機會。我們公司規模較小，所以收到的諮詢遠超過我們的接待能力，但我們仍然感謝您的關注。

We're most proud and appreciative of our team, including those external partners who continue to contribute to the progress and success underway at GeoVax. For all of us, it's a great pleasure serving our shareholders and being a part of this team. Our overriding goal is to improve lives worldwide through our development and commercialization of novel critically needed cancer therapies and infectious disease vaccines.

我們為我們的團隊感到無比自豪和感激，也感謝那些繼續為 GeoVax 的發展和成功做出貢獻的外部合作夥伴。對我們所有人來說，能夠為股東服務並成為這個團隊的一份子，是一件非常愉快的事情。我們的首要目標是透過開發和商業化急需的新型癌症療法和傳染病疫苗，改善全世界人民的生活。

And with that, I want to wish everyone a safe and enjoyable day. And again, thank you for your time and attention.

最後，祝大家平安愉快。再次感謝您的時間和關注。

This concludes today's program. Thank you for participating. You may now disconnect.

今天的節目到此結束。感謝您的參與。您現在可以斷開連線了。