GeoVax Labs Inc (GOVX) 2024 Q3 法說會逐字稿

Good afternoon and welcome, everyone, to the GeoVax third-quarter 2024 corporate update call. My name is Michelle, and I'll facilitate today's call. With me are David Dodd, Chairman, CEO; Mark Reynolds, Chief Financial Officer; Mark Newman, PhD, Chief Scientific Officer; Kelly McKee, MD, MPH, Chief Medical Officer; and John Sharkey, PhD, Vice President, Business Development.

下午好，歡迎大家參加 GeoVax 2024 第三季公司更新電話會議。我叫米歇爾，我將主持今天的電話會議。與我一起的是董事長兼執行長 David Dodd；雷諾茲（Mark Reynolds），財務長；馬克紐曼博士，首席科學官； Kelly McKee 醫學博士、公共衛生碩士，首席醫療官；以及業務發展副總裁 John Sharkey 博士。

(Operator Instructions) As a reminder, this conference is being recorded. At this time, I'm turning the call over to Max Gadicke of Precision AQ.

（操作員指示）提醒一下，本次會議正在錄音。現在，我將電話轉給 Precision AQ 的 Max Gadicke。

Thank you. 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 weather.

謝謝。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》所定義的前瞻性陳述。這些聲明是基於管理層目前的預期，並受不確定性和情況變化的影響。由於天氣等多種因素，實際結果可能與這些聲明中的結果有重大差異。

GeoVax can develop and manufacture its product candidates with desired characteristics in a timely manner and such products will be safe for human use. 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.

GeoVax 可以及時開發和生產具有所需特性的候選產品，且此類產品對人類使用是安全的。GeoVax 的疫苗將有效預防人類的目標感染。GeoVax 的候選產品將獲得許可和行銷所需的監管批准。GeoVax 籌集所需資金以完成其產品的開發。

There is development of competitive products that may be more effective or easier to use than GeoVax's products. 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.

已經開發出的競爭產品可能比 GeoVax 的產品更有效或更容易使用。GeoVax 將能夠達成有利的製造和分銷協議以及 GeoVax 無法控制的其他因素。GeoVax 不承擔更新這些前瞻性聲明的義務，也不打算這樣做。

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.

有關這些因素的更多資​​訊包含在 GeoVax 提交給美國證券交易委員會的文件中，包括 GeoVax 10-K 表格中「風險因素」中列出的資訊。

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

現在我很高興介紹 GeoVax 董事長兼執行長 David Dodd。

It's a pleasure to welcome everyone to the third-quarter 2024 GeoVax corporate update call. Following my comments, Mark Reynolds, our CFO will provide an update of our financials and then your questions will be addressed.

很高興歡迎大家參加 2024 年第三季 GeoVax 公司更新電話會議。在我發表評論之後，我們的財務長馬克雷諾茲將提供我們的財務狀況更新，然後解答您的問題。

The third quarter included several major events in the development of GeoVax led by the BARDA Project NextGen award valued at almost $400 million being announced during mid-June. This program is already underway with confirmation that all study sites have been selected as well as our ongoing billings to BARDA. Mark will further discuss this during the financial review.

第三季度，GeoVax 研發過程中發生了幾件大事，其中最為重要的是 6 月中旬宣布的 BARDA 專案 NextGen 獎項，該獎項的價值近 4 億美元。該計劃已經在進行中，並已確認已選定所有研究地點，且我們正在向 BARDA 支付持續的帳單。馬克將在財務審查期間進一步討論這個問題。

We're delighted to have been paired by BARDA with Allucent as our CRO for the Project NextGen trial, as Allucent is our existing CRO supporting our ongoing CM04S1 in recently completed Gedeptin clinical trials. In addition during quarter three, we announced plans to conduct a Phase 2 trial Gedeptin in combination with an immune checkpoint inhibitor among patients with locally recurrent head and neck squamous cell carcinomas, following primary therapy and for whom resection with curative intent as planned.

我們很高興能與 BARDA 合作，讓 Allucent 作為我們 NextGen 計畫試驗的 CRO，因為 Allucent 是我們現有的 CRO，支持我們在最近完成的 Gedeptin 臨床試驗中正在進行的 CM04S1。此外，在第三季度，我們宣布計劃對局部復發性頭頸部鱗狀細胞癌患者進行 Gedeptin 與免疫檢查點抑制劑聯合治療的 2 期試驗，這些患者已接受原發性治療並按計劃進行治癒性切除。

Thus far, our clinical evaluation of Gedeptin therapy has demonstrated an acceptable safety profile and sufficient tumor stabilization or reduction activity to support plans to advance clinical development of Gedeptin in such an expanded Phase 2 clinical trial.

到目前為止，我們對 Gedeptin 療法的臨床評估已證明其具有可接受的安全性和足夠的腫瘤穩定或減少活性，以支持在這種擴大的 2 期臨床試驗中推進 Gedeptin 臨床開發的計劃。

Relative to GEO-MVA, our vaccine candidate against mpox and smallpox, we've continued to advance the program this past quarter from having the cGMP production of a Master Seed Virus to establishing the working seed virus and currently having production of the first cGMP clinical substance batch underway with release anticipated by year end.

相對於 GEO-MVA（我們針對 mpox 和天花的候選疫苗），我們在過去的一個季度繼續推進該計劃，從擁有主種子病毒的 cGMP 生產到建立工作種子病毒，目前正在生產第一批 cGMP 臨床物質，預計年底前發布。

In addition, we are moving forward with our advanced MVA manufacturing process with preparation of our [AGE1] master cell bank being initiated. These activities represent significant progress and milestones for GeoVax. 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.

此外，我們正在推動先進的 MVA 製造工藝，並開始準備 [AGE1] 主細胞庫。這些活動代表了 GeoVax 的重大進展和里程碑。我們的目標是成功開發創新的癌症療法和傳染病疫苗，解決至關重要的未滿足的醫療需求，並尋求支持快速註冊途徑的初步適應症。

We anticipate establishing business partnerships and collaborations in support of worldwide development, commercialization, and distribution. In late July, we announced plans to initiate a Phase 2 trial with Gedeptin combination with an immune checkpoint inhibitor for treatment of previously treated patients with recurrent head and neck cancer.

我們期待建立商業夥伴關係和合作關係，以支持全球開發、商業化和分銷。7 月下旬，我們宣布計劃啟動 Gedeptin 與免疫檢查點抑制劑聯合治療的 2 期試驗，用於治療先前接受過治療的複發性頭頸癌患者。

The primary goal of this trial will be to demonstrate a pathological response with neoadjuvant Gedeptin therapy, combined with an immune checkpoint inhibitor and previously treated patients with recurrent squamous cell head and neck cancer, in whom surgery with curative intent is planned. The company has initiated the necessary planning activities including protocol development, manufacturing, and CRO selection with the trial activation anticipated during 2025.

該試驗的主要目標是證明新輔助 Gedeptin 療法聯合免疫檢查點抑制劑對復發性鱗狀細胞頭頸癌患者俱有良好的病理反應，這些患者計劃接受手術治癒。該公司已啟動必要的規劃活動，包括協議開發、製造和 CRO 選擇，預計於 2025 年啟動試驗。

We believe that the Gedeptin mechanism of action will enable us to address a variety of solid tumors, both cancerous and benign. We hold worldwide rights for all indications of this technology and we're participating in various oncology and partnering conferences. We're encouraged by the clinical results we've seen thus far. We're even more excited about trial activation as soon as possible.

我們相信，Gedeptin 的作用機制將使我們能夠治療各種實體腫瘤，包括癌性和良性腫瘤。我們擁有該技術所有適應症的全球權利，並且我們正在參加各種腫瘤學和合作會議。迄今為止所見的臨床結果令我們感到鼓舞。我們對盡快啟動試用版感到更加興奮。

Our big news recently was the announcement of the BARDA Project NextGen award of almost $400 million supporting GEO-CM04S1 in a 10,000-patient comparative trial against an FDA-authorized mRNA vaccine. This represents a highly significant event in the evolution of our company which we believe represents a validation of our MVA technology and expertise.

我們最近的重大新聞是，BARDA 計畫 NextGen 宣布獲得近 4 億美元的獎金，支持 GEO-CM04S1 進行 10,000 名患者的試驗，與 FDA 授權的 mRNA 疫苗進行對比試驗。這是我們公司發展歷程中具有重要意義的事件，我們相信這代表了對我們的 MVA 技術和專業知識的驗證。

The vetting process was lengthy and rigorous, but we remain confident throughout and we're delighted to be part of the Project NextGen vaccine program. Let me note that our vaccine selection represents one of only six vaccines awarded under Project NextGen. Already, all participating sites have been identified selected by Allucent and manufacturing activities are proceeding in support of the study start during 2025.

審查過程漫長而嚴格，但我們始終充滿信心，很高興成為 Project NextGen 疫苗計劃的一部分。我要指出的是，我們選擇的疫苗是 NextGen 計畫授予的僅有的六種疫苗之一。目前，所有參與地點已被 Allucent 確定和選定，製造活動正在進行中，以支持 2025 年啟動的研究。

Our aim with CM04S1 is to provide a more practical public health friendly COVID-19 vaccine than that offered from the first-generation approved vaccine. We believe that this is achieved by stimulating a robust and durable immune response across multiple virus variants as a result of the induction of both the antibody and cellular arms of the immune system against multiple virus antigens.

我們對 CM04S1 的目標是提供比第一代批准疫苗更實用、更有利於公共衛生的 COVID-19 疫苗。我們相信，這是透過誘導免疫系統的抗體和細胞臂針對多種病毒抗原，刺激對多種病毒變體產生強大而持久的免疫反應來實現的。

This distinction is critically important in addressing the high-risk populations of immunocompromised individuals for whom the current vaccines are often inadequate. This represents the key differentiation between our vaccine and the first-generation authorized vaccines.

這種區別對於解決免疫功能低下的高風險族群至關重要，因為目前的疫苗往往不足以治療這些族群。這是我們疫苗與第一代授權疫苗之間的關鍵差異。

Our vaccine utilizes a proven safe and efficient delivery platform, modified Vaccinia Ankara or MVA, which does not replicate in mammalian cells. The safety of MVA has been well-established and accepted by regulatory authorities worldwide, especially among patients with weakened immune systems, such as among pregnant women.

我們的疫苗採用經過驗證的安全有效的遞送平台，改良的安卡拉痘苗或 MVA，它不會在哺乳動物細胞中複製。MVA 的安全性已得到世界各地監管機構的充分認可和接受，尤其是對於免疫系統較弱的患者（例如孕婦）而言。

That our vaccine platform MVA is also a standalone vaccine authorized for protection against mpox and smallpox, is a unique feature which critically important clinical benefits providing a significant differentiator for CM04S1, especially when considered as a potential COVID-19 vaccine in regions endemic to mpox. A current example is within the Democratic Republic of the Congo or the DRC, where there is a threatening outbreak underway.

我們的疫苗平台 MVA 也是一種獲準用於預防 mpox 和天花的獨立疫苗，這是一項獨特的功能，其至關重要的臨床益處為 CM04S1 提供了顯著的差異化因素，尤其是當被視為 mpox 流行地區的潛在 COVID-19 疫苗時。目前的一個例子是剛果民主共和國，即剛果民主共和國，那裡正在發生一場威脅性的疫情。

Also, the CDC recently issued a warning of continued mpox threats and risk within the US. In addition to its benefits in immunocompromised individuals and protecting from severe COVID-19, we believe that CM04S1 has the potential for more general use as a heterologous booster to current mRNA vaccines, providing a durable and broadly functional immune response against emerging variants.

此外，疾病預防控制中心最近也發出警告，稱美國境內仍存在 mpox 威脅和風險。除了對免疫功能低下的個體有益並可預防嚴重的 COVID-19 之外，我們相信 CM04S1 還可以作為當前 mRNA 疫苗的異源增強劑得到更廣泛的應用，從而針對新出現的變種提供持久且廣泛功能的免疫反應。

The intriguing possibility is that GEO-CM04S1 could, by virtue of this immune profile, reduce the need for continuous vaccine reconfiguration that appears necessary with the mRNA vaccines. In fact, the HHS press release announcing our Project NextGen award specifically highlighted our award as providing the potential for a COVID-19 vaccine that provides broader protection, meaning encompassing a wider variety of variants and the potential for increased durability than that evidenced by the current authorized vaccines.

有趣的可能性是，GEO-CM04S1 可以憑藉這種免疫特性減少 mRNA 疫苗似乎必需的持續疫苗重新配置的需要。事實上，美國衛生與公共服務部在宣布我們的 NextGen 計畫獲獎的新聞稿中特別強調，我們的獎項為研製出一種能提供更廣泛保護的 COVID-19 疫苗提供了潛力，這意味著它涵蓋了更廣泛的變體，並且比目前授權的疫苗具有更高的耐用性。

The current data thus far from our existing Phase 2 studies is supportive of that potential. Relative to CM04S1, we anticipate partnering collaborations and additional clinical and research efforts and in support of worldwide commercialization distribution. Active initiatives are underway in these areas.

我們現有的第 2 階段研究迄今為止的數據支持這一潛力。相對於 CM04S1，我們期待合作夥伴和額外的臨床和研究努力，並支持全球商業化分銷。這些領域正在進行積極的措施。

Three Phase 2 clinical trials are underway with CM04S1, two of which address populations of immunocompromised patients at high risk for developing severe COVID-19. The other Phase 2 trial evaluates our vaccine as a heterologous booster among healthy adults following prior receipt of an mRNA vaccine.

CM04S1 目前正在進行三項 2 期臨床試驗，其中兩項針對嚴重 COVID-19 高風險的免疫功能低下患者群體。另一項 2 期試驗評估了我們的疫苗在健康成年人中作為異源加強劑在先前接種 mRNA 疫苗後的效果。

Overall, we hope to demonstrate that our COVID-19 vaccine successfully addresses the current unmet needs among the tens of millions of immunocompromised patients, while also demonstrating the vaccine is a more robust durable booster vaccine used in conjunction with mRNA vaccines. I won't delve further into these specific trials at this time, but we welcome any questions you may have during our Q&A session.

總的來說，我們希望證明我們的 COVID-19 疫苗成功滿足了數千萬免疫功能低下患者目前未滿足的需求，同時也證明該疫苗是一種與 mRNA 疫苗配合使用的更強效、更持久的加強疫苗。我目前不會深入探討這些具體的試驗，但我們歡迎您在問答環節提出任何問題。

With the announcement of our Project NextGen award and the progress in our other Phase 2 clinical studies, our activities related to partnering and collaborations with GEO-CM04S1 have increased. We believe that GEO-CM04S1 represents significant promise as a critically needed and important part of the COVID-19 vaccine armamentarium for public health worldwide.

隨著我們的 Project NextGen 獎項的發表以及其他第 2 階段臨床研究的進展，我們與 GEO-CM04S1 合作的相關活動有所增加。我們相信，GEO-CM04S1 作為全球公共衛生急需的 COVID-19 疫苗武器庫的重要組成部分，具有巨大的前景。

In August, the WHO declared mpox as a public health emergency of international concern. Highlighting the critical medical threat posed by this highly virulent virus, GeoVax is well-positioned and actively progressing GEO-MVA, our vaccine against mpox and smallpox intended to disrupt the current global monopoly in that important area. Moreover, we believe that our efforts will establish GeoVax as the first US-based supplier of such a vaccine.

8月，世界衛生組織宣布mpox為國際關注的突發公共衛生事件。鑑於這種高毒性病毒對醫療造成的嚴重威脅，GeoVax 已做好充分準備並積極推進 GEO-MVA，這是我們針對麻疹和天花的疫苗，旨在打破這一重要領域的當前全球壟斷。此外，我們相信，我們的努力將使 GeoVax 成為第一家美國此類疫苗供應商。

This may also provide GeoVax our initial step into revenue generation to the significant governmental interest in US-based supply chains versus overdependence on non-US suppliers. The strong sentiment in favor of such own-sourcing initiatives remains a major national legislative focus and interest.

這也可能為 GeoVax 提供創造收入的第一步，以滿足政府對美國供應鏈的極大興趣，避免過度依賴非美國供應商。對此類自有採購措施的強烈支持仍然是國家立法的主要關注點和興趣。

We remain in active discussions and briefings with various stakeholders such as the White House, BARDA, WHO, the African CDC, and others regarding our progress towards having a cGMP clinical batch produced and manufacturing capabilities advancing. WHO has clearly stated the expectation of continued expanded migration of the mpox virus reflected in recent reports of multiple cases in the UK.

我們仍在與白宮、生物醫學高級研究與發展局、世衛組織、非洲疾病預防控制中心等各利益相關方進行積極的討論和通報，討論我們在實現 cGMP 臨床批量生產和提高製造能力方面取得的進展。世衛組織已明確表示，預計英國近期報告的多起病例將持續擴大傳播。

The need for expanded mpox vaccine supply is a priority for WHO and other public health agencies globally. Finally, we anticipate providing continued updates related to our advanced MVA manufacturing process targeted to enable GeoVax to efficiently produce and distribute MVA-based vaccines in response to real-time market needs.

擴大mpox疫苗供應是世衛組織和全球其他公共衛生機構的首要任務。最後，我們期待持續提供與我們先進的 MVA 製造流程相關的更新，旨在使 GeoVax 能夠根據即時市場需求高效生產和分銷基於 MVA 的疫苗。

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. From a commercial perspective, these medical need opportunities represent a tremendous estimated annual US revenue potential.

我們相信，我們正走在一條能夠為股東和利害關係人創造巨大價值的道路之上，同時提供至關重要的差異化產品，以改善全世界的生活。從商業角度來看，這些醫療需求機會代表著美國巨大的預計年收入潛力。

I'll underscore that this isn't a sales forecast but rather a reflection of the significance of the need to address these critically important areas of healthcare both clinically and commercially. Expanding this to a worldwide basis in conjunction with partners and collaborators adds to the confidence we have relative to the outlook for GeoVax, our shareholders, and our stakeholders.

我要強調的是，這不是銷售預測，而是在臨床和商業上解決這些至關重要的醫療保健領域的重要性的反映。與合作夥伴和合作者一起將此擴展到全球範圍，增強了我們對 GeoVax、我們的股東和利害關係人的前景的信心。

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

現在，我想將演講交給 GeoVax 的財務長 Mark Reynolds，讓他回顧我們最近的業績和財務步驟。標記？

Thank you, David. I'll start reviewing with the income statement to begin with. Our contract with BARDA began on June 12, so there were minimal revenues reported during the second quarter. During the third quarter end of September 30, we reported $2.8 million of revenues and $3.1 million for the nine-month period. There were no comparable revenues reported during the 2023 periods.

謝謝你，大衛。首先，我將開始審查損益表。我們與 BARDA 的合約於 6 月 12 日開始，因此第二季的收入很少。截至 9 月 30 日的第三季度，我們報告的收入為 280 萬美元，前九個月的收入為 310 萬美元。2023 年期間沒有報告可比較收入。

This is a cost reimbursement contract. So future revenues will directly correlate with our billable personnel time and incremental expenses incurred. The total contract value direct to GeoVax is currently $26 million but may actually increase up to $45 million. And keep in mind that a separate contract of $443 million was awarded directly to Allucent, the CRO that is conducting our trial. Those revenues won't show up in our financial statements.

這是一個成本補償合約。因此，未來的收入將與我們的計費人員時間和發生的增量費用直接相關。目前與 GeoVax 直接簽訂的合約總價值為 2,600 萬美元，但實際上可能會增至 4,500 萬美元。請記住，另一份價值 4.43 億美元的合約已直接授予負責我們試驗的 CRO Allucent。這些收入不會出現在我們的財務報表中。

Research and development expenses were $16.1 million during the first nine months of 2024 versus $14.5 million in 2023, representing an increase of roughly $1.6 million or 11%. This year-over-year increase is primarily associated with the cost of manufacturing clinical trial materials and other costs associated with the BARDA contract.

2024 年前 9 個月的研發費用為 1,610 萬美元，而 2023 年為 1,450 萬美元，增加約 160 萬美元，即 11%。這一同比增長主要與製造臨床試驗材料的成本以及與 BARDA 合約相關的其他成本有關。

General administrative expenses were $3.8 million for the nine-month period in 2024 versus $4.6 million in 2023, representing a decrease of around $800,000 or 17%, primarily associated with lower stock-based compensation expense and a mix of other costs.

2024 年九個月的一般行政費用為 380 萬美元，而 2023 年為 460 萬美元，減少約 80 萬美元或 17%，主要與股票薪資費用降低以及其他成本有關。

Other income and expense was $70,000 in 2024 as compared to $675,000 in 2023, primarily reflecting lower interest income due to lower cash balances invested through our money market accounts. So overall net loss for the first nine months of 2024 was approximately $16.7 million or $4.52 per share versus $18.4 million in 2023 or $10.42 per share. Again, with the increase primarily being driven by manufacturing activities and costs associated with the BARDA contract.

2024 年其他收入和支出為 70,000 美元，而 2023 年為 675,000 美元，主要反映了由於透過我們的貨幣市場帳戶投資的現金餘額減少而導致的利息收入減少。因此，2024 年前 9 個月的整體淨虧損約為 1,670 萬美元或每股 4.52 美元，而 2023 年為 1,840 萬美元或每股 10.42 美元。再次，成長主要是由製造活動和與 BARDA 合約相關的成本推動的。

Turning now to the balance sheet, our cash balances at September 30 were $8.6 million compared to $6.5 million at December 31, 2023, reflective of $16.9 million used in operating activities offset by $19.1 million in financing transactions along with changes to our non-cash asset and liability balances.

現在來看看資產負債表，我們 9 月 30 日的現金餘額為 860 萬美元，而 2023 年 12 月 31 日的現金餘額為 650 萬美元，其中經營活動中使用的 1690 萬美元被融資交易中的 1910 萬美元所抵消，以及我們的非現金資產和負債的變化。

Our outstanding common shares currently stand at $9.4 million following the recent financings. Going forward, supporting the BARDA Project NextGen award is our top priority in terms of operational focus and the significant use of our research and development personnel. But it's important to keep in mind that the entire clinical program is fully funded by BARDA through the awards to GeoVax and through Allucent, our CRO partner.

經過最近的融資，我們目前已發行的普通股為 940 萬美元。展望未來，從營運重點和充分利用我們的研發人員的角度來看，支持 BARDA 計畫 NextGen 獎是我們的首要任務。但重要的是要記住，整個臨床計畫完全由 BARDA 透過授予 GeoVax 的獎項和透過我們的 CRO 合作夥伴 Allucent 資助。

In terms of actual funding needs in the Gedeptin and CM04S1 clinical programs as well as the development activities for the GEO-MVA mpox program will be the most significant use of our cash for the foreseeable future. We are currently developing our capital formation plans to fund those programs through several valuation inflection points.

就Gedeptin和CM04S1臨床專案的實際資金需求而言，以及GEO-MVA mpox專案的開發活動將是我們可預見的未來現金的最重要用途。我們目前正在製定資本形成計劃，透過幾個估值轉折點為這些項目提供資金。

I'll be happy to answer any further 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其他問題，現在我將把電話轉回給大衛。

Thank you, Mark. My colleagues and I will now answer your question. Joining us for the Q&A session are doctors 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。我和我的同事現在將回答您的問題。參加問答環節的有醫生 Mark Newman、Kelly McKee 和 John Sharkey；分別是我們的首席科學官、首席醫療官和業務發展副總裁。

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

我現在將把電話轉給接線員，以獲取有關問答環節的指示。

(Operator Instructions) Jonathan Aschoff, Roth Capital Partners.

（操作員指示）Jonathan Aschoff，Roth Capital Partners。

Thank you. Good afternoon, guys. I was curious regarding that AGE1 cell line for MVA manufacturing. What must you do to submit test batches to the FDA to get to that point? And can you help us on that timing?

謝謝。大家下午好。我對用於 MVA 製造的 AGE1 細胞系感到好奇。為了達到這一點，您必須做什麼才能向 FDA 提交測試批次？您能幫我們確定時間嗎？

Sure, Jonathan, this is David. Thanks for your question. I'm going to ask Mark Newman and also perhaps John Sharkey to weigh in on that.

當然，喬納森，這是大衛。感謝您的提問。我將請馬克紐曼和約翰沙基對此發表看法。

Okay. So there's a pretty standard process of valuation that we would go through and process development. And I mean, that's well-defined to the regulatory agencies. The key element will be purifying the virus to again, standards that are acceptable by the FDA. We're just starting on the process development on that and generating -- we have plans to find -- to generate cell banks.

好的。因此，我們會經歷一個非常標準的評估流程和流程開發過程。我的意思是，這對監管機構來說是明確的。關鍵因素是再次淨化病毒，使其達到 FDA 可接受的標準。我們才剛開始進行這方面的流程開發和生成——我們有計劃尋找——生成細胞庫。

So giving you timing on it would be a bit difficult. But I could estimate that once we start throwing people at it, this was qualifying the cell line, getting to where we want, and then starting to run test batches which would not be GMP but would be products where we test quality of the virus quality of our process purity. That's probably an 18-month process minimum. But it could potentially be -- this is one of those areas where you can put more effort on it and more people and expedite it if there's a reason to do so.

因此給你時間安排可能會有點困難。但我可以估計，一旦我們開始投入人員，這將使細胞係得到鑑定，達到我們想要的水平，然後開始運行測試批次，這些批次雖然不是 GMP，但會是我們測試病毒品質和製程純度的產品。這可能至少需要 18 個月的時間。但它可能是——如果有理由的話，這是一個你可以投入更多精力、更多人力並加快進程的領域之一。

Okay, thanks for that. David, when might -- for both the CLL and the healthy volunteer trials, when would we be able to see interim and final results respectively for those two trials?

好的，謝謝。大衛，對於 CLL 和健康志願者試驗，我們什麼時候才能分別看到這兩項試驗的中期和最終結果？

I think, clearly, this quarter and probably sooner rather than later. But before year end, we anticipate to be announcing and reporting of the interim results for the CLL study as well as the final result. Now, the final results for the healthy volunteer, just from the basis of knowing a little bit about where the statisticians are, that could move into early next year. But as you're aware, that's a completed study, it's being cleaned up, the database analysis is being done.

我認為，顯然，本季就會出現這種情況，而且很可能很快就會出現。但在年底之前，我們預計將宣布並報告 CLL 研究的中期結果以及最終結果。現在，僅從對統計人員所在位置的了解來看，健康志工的最終結果可能會在明年年初公佈。但正如您所知，這是一項已經完成的研究，正在清理中，資料庫分析正在進行中。

And we're obviously urging the statistician to move faster rather than slower. So our goal is to be able to report both by year end. I think with certainty, we feel regarding the interim results of the CLL study and relative to the healthy volunteer booster trial, that may hold over into early next year. But we're hoping that it (inaudible).

我們顯然敦促統計人員加快步伐，而不是放慢速度。因此我們的目標是能夠在年底前報告這兩項結果。我認為，我們可以肯定地認為，就 CLL 研究的中期結果以及相對於健康志願者加強試驗而言，這可能會持續到明年年初。但我們希望它（聽不清楚）。

Okay. And then, last couple are just -- have you made much progress -- can you tell us the progress that you've made in your request for expedited regulatory pathway for mpox? And then, I just saw nothing about when you'll start enrolling trial of patients in your 10,000-patient Phase 2 COVID trial. I was just hoping that was something that was at least going to start by the middle of 2025, but you gave no timing on that.

好的。然後，最後幾個問題是——您是否取得了很大進展——您能告訴我們您在請求加快 mpox 監管途徑方面取得了哪些進展嗎？然後，我沒有看到任何關於何時開始在涉及 10,000 名患者的第二階段 COVID 試驗中招募患者的資訊。我只是希望這件事至少能在 2025 年中期開始，但你沒有給出具體時間。

So I was wondering when you could start enrolling those patients and the progress you made in expediting regulatory pathway for mpox?

所以我想知道您什麼時候可以開始招募這些患者，以及您在加快 mpox 監管途徑方面取得了什麼進展？

So let me ask John Sharkey, who also serves as our Executive Lead on the GEO-MVA. So to discuss that one, and then I'll ask for Doctor Kelly McKee to then address the Project NextGen, study starts.

所以我想問約翰‧沙基 (John Sharkey)，他也是 GEO-MVA 的執行負責人。因此，為了討論這個問題，然後我會請凱利·麥基博士來談談下一代計劃，研究開始了。

Sure. Hey, Jonathan. We have not disclosed our regulatory strategy per se. But what I can share is we are in active engagement with the regulators. The guidance we're getting is because it is MVA, generally recognized to say that we're manufacturing on the chicken embryo fibroblast platform for the initial registration that there is indeed, an expedited pathway for us that will involve abbreviated trial structure, and probably at most of bridging costs in animal models.

當然。嘿，喬納森。我們尚未披露我們的監管策略本身。但我可以分享的是，我們正在與監管機構積極合作。我們獲得的指導是因為它是 MVA，普遍認可我們在雞胚成纖維細胞平台上進行初始註冊的生產，這對我們來說確實是一條快速途徑，其中將涉及縮短的試驗結構，並且很可能最多涉及動物模型的橋接成本。

We are continuing those discussions with the agency to finalize agreement on the clinical protocol design as well as what if any additional animal work they would want to see to support the registration. But they've been clear that they do not see a need for us to do the traditional [pull-tops] Phase 1, Phase 2, Phase 3 for this asset given that it is MVA that ancestrally, it's very close to what is already approved. And we are, for the initial product introduction, will be using the chicken embryo fibroblast platform.

我們將繼續與該機構進行討論，以最終就臨床方案設計達成協議，並確定他們希望看到哪些額外的動物研究來支持​​註冊。但他們已經明確表示，他們認為我們沒有必要對這項資產進行傳統的 [拉頂] 第 1 階段、第 2 階段和第 3 階段，因為從祖先來看，它是 MVA，與已經批准的資產非常接近。對於初始產品介紹，我們將使用雞胚成纖維細胞平台。

Okay. And so, you wouldn't even have to do efficacy in animals?

好的。那麼，你甚至不需要在動物身上進行功效測試嗎？

Well, remember how MVA is approved for smallpox and monkeypox, it is approved with an immunological evaluation in humans as well as safety. Efficacy is demonstrated in animal models. We are having discussions with them, what if any efficacy parameter would they want to see in an animal model to basically match the immunological response we're going to measure. If they end up requiring an animal efficacy [like], we could run that in parallel with the clinical trial. So it would not be, at all, rate-limiting for us. The rate-limiting will be running the immunological trial.

好吧，記住 MVA 是如何被批准用於治療天花和猴痘的，它是經過人類免疫學評估和安全性測試後才被批准的。動物模型證明了其功效。我們正在與他們討論，他們希望在動物模型中看到什麼樣的功效參數才能與我們要測量的免疫反應基本相符。如果他們最終需要動物療效測試，我們可以將其與臨床試驗同時進行。所以這對我們來說根本不會是限制速度的限制。限速將進行免疫學試驗。

Thank you. And just finally, the NextGen trial start timing?

謝謝。最後，NextGen 試驗的開始時間是什麼時候？

Yeah. Hi, Jonathan. This is Kelly. Right now, we are projecting enrollment to begin around October 1, the early part of October of 2025. That's being driven by the sort of manufacturing timelines. And that's kind of where we are.

是的。你好，喬納森。這是凱利。目前，我們預計報名將於 2025 年 10 月 1 日左右（10 月初）開始。這是由製造時間表決定的。這就是我們現在的狀況。

Okay. Thank you very much, guys.

好的。非常感謝你們。

James Molloy, Alliance Global Partners.

聯盟全球合作夥伴 (Alliance Global Partners) 的詹姆斯‧莫洛伊 (James Molloy)。

Thank you very much. Looking up past the fourth quarter here, what are the sort of the next steps we should anticipate here for in early '25 for the primary vaccine trial, the CLL trial, the booster vaccine trial, all of which are putting out data end of this year, early next? What kind of next steps we should anticipate and where -- what's the sort of end game on each of those trials where you can go to the FDA and start talking about the next steps or potentially filing?

非常感謝。展望第四季之後，我們應該預期 25 年初的主要疫苗試驗、CLL 試驗和加強疫苗試驗將採取哪些後續措施？我們應該預期下一步採取什麼措施，以及每個試驗的最終結果是什麼，您可以前往 FDA 討論下一步或可能提交申請？

Jim, thank you. This is David. I'll touch on those and then Kelly, if you want to add to it. But the way we're looking at it is we want to see the results of the -- the interim results of the CLL trial. Remember, that's an investigator-initiated trial. We've always felt that such a high need compromised population that there is an opportunity, we believe, for an expedited development process.

吉姆，謝謝你。這是大衛。我會談及這些，然後凱利，如果你想補充的話。但我們的看法是，我們希望看到 CLL 試驗的中期結果。請記住，這是一項由研究人員發起的試驗。我們一直認為，如此高的需求會損害民眾的利益，因此我們相信有機會加快發展進程。

We'll look at the results. We'll decide to -- do we want to go forward with the company-sponsored trial and pursue that? That would involve also discussions in advance with the agency about our plans, et cetera, what the outcome might be. From the healthy volunteer trial, it's really -- we're seeking to see the final results from there when one thinks about it.

我們將看看結果。我們將決定—我們是否要繼續進行由公司贊助的試驗並追求這一點？這也涉及提前與該機構討論我們的計劃等等，以及結果可能會是什麼。從健康志願者試驗來看，我們確實希望看到最終的結果。

Project NextGen is actually the expansion of that. It's a much larger trial. It's generally healthy but it's a very diverse population type of boat of study participants. And also, it's a comparative trial. Our stem cell transplant trial continues to add sites and enrollment. And I guess, I'd say with that, Kelly, would you like to pick up, add any other comments on this on our trials for CM04S1?

Project NextGen 實際上是它的擴充。這是一次更大規模的試驗。總體而言，他們是健康的，但研究參與者的群體類型非常多樣化。而且這也是一次比較試驗。我們的幹細胞移植試驗持續增加地點和招募人數。我想，凱利，你想就我們對 CM04S1 的試驗發表任何其他評論嗎？

No, you pretty much hit the high points. Just to keep in mind, the healthy volunteer study, we're comparing two doses of the vaccine. There's no active control and there's no placebo control in that study. And so, we're not anticipating any surprises to come out of that. But as David indicated, we should have results of that by sort of sometime in the first quarter of 2025, I think.

不，你幾乎已經達到最高點了。請記住，在健康志願者研究中，我們正在比較兩劑疫苗。研究中沒有主動對照，也沒有安慰劑對照。因此，我們預計不會有任何意外情況。但正如大衛所說，我認為我們應該會在 2025 年第一季的某個時候得到結果。

For the cell transplant study, we're continuing to enroll our current trial. We anticipate continuing that enrollment through the end of next year. We've added a couple of additional sites which should be coming online very shortly. I mean, literally within weeks. Two additional sites to add to the three that are currently enrolling patients. We've got patients in active screening. So we're adding to the number that we've already enrolled, which is around 31 patients up to this point in time.

對於細胞移植研究，我們正在繼續招募目前的試驗。我們預計招生將持續到明年年底。我們添加了幾個額外的網站，它們很快就會上線。我的意思是，實際上在幾週之內。除目前正在招募患者的三個站點外，再增加兩個站點。我們已有患者正在接受主動篩檢。因此，我們正在增加已招募的患者人數，到目前為止，大約有 31 名患者。

So that study is continuing to acquire -- accumulate data, which will be very important to us going forward. It's not a registrational trial. We sort of recognize that from the outset. But the data that's coming out of that study is going to be very supportive to any registrational trial that we do.

因此，這項研究正在繼續獲取和累積數據，這對我們未來的發展非常重要。這不是註冊試驗。我們從一開始就意識到了這一點。但該研究得出的數據將對我們進行的任何註冊試驗提供非常強大的支持。

We have another sort of more robust trial designed -- the study protocol drafted already and we're ready to launch that at the conclusion of this study, of the current study, which I think, again, with the data from the current study added to it, should give us a pretty -- should position us pretty well to go talk to the agency about the registrational pathway.

我們設計了另一種更為強有力的試驗——研究方案已經起草完畢，我們準備在本項研究、當前研究結束時啟動該方案，我認為，加上當前研究的數據，我們應該能夠很好地與該機構討論註冊途徑。

Thank you. And then on mpox and smallpox. A few folks -- you're looking to get some vaccines together for these -- who do you see as sort of the clear leaders? It;s not yourselves, of course, in this space. And what do you think gets you to the finish line? Who do you think will get to the finish line first there? What do you think, it's something where you'll need multiple vaccines, different populations? What have you --?

謝謝。然後是 mpox 和天花。有些人——你們正在為這些目標尋找一些疫苗——你們認為誰是明顯的領導者？當然，在這個空間裡，不是你們自己。您認為什麼能讓您到達終點？您認為誰會第一個到達終點？您認為不同族群是否需要多種疫苗？你有什麼--？

Yeah, John, do you want to pick up on that?

是的，約翰，你想繼續說下去嗎？

Sure. So the benefit of -- I mean, there's three vaccines out there. There's ACAM2000 vaccinia, which is indicated as usable in healthy individuals. There's LC16, which was registered in Japan and that was tested in children. The vaccinias are replicating virus, the LC16 is a minimally rep -- they referred to it as the minimally replicating virus. Then there's MVA which doesn't replicate.

當然。所以好處是——我的意思是，目前有三種疫苗。有ACAM2000痘苗，顯示其適用於健康個體。LC16 已在日本註冊，並且已經在兒童身上進行過測試。痘苗病毒是一種複製型病毒，LC16 病毒是最低限度複製型病毒－他們稱之為最低限度複製病毒。然後還有無法複製的 MVA。

So the nice part about MVA, when you look at the WHO recommendation, it's recommended for healthy individuals, the immunocompromised, pregnant women, lactating women, children, as preferred vaccine. So given all things being equal as far as availability, I think the general trend is if you have the option, you vaccinate with MVA because you don't have to worry about the patient's current health state.

因此，MVA 的優點在於，當您查看 WHO 的建議時，它被推薦用於健康個體、免疫功能低下者、孕婦、哺乳期婦女和兒童，作為首選疫苗。因此，在可用性方面，考慮到所有條件相同，我認為總體趨勢是，如果您可以選擇，您可以接種 MVA 疫苗，因為您不必擔心患者當前的健康狀況。

So we believe that the MVA will remain the preferred product in this space. The other ones are there and depending on need, can be used. But our general sense of talking with people is that MVA is the preferred product. It is currently right now as you well know, a single-source manufacturer, very complicated manufacturing process.

因此我們相信 MVA 仍將是該領域的首選產品。其他的都可以，根據需要使用。但我們與人們交談中的普遍感覺是，MVA 是首選產品。眾所周知，它目前是單一來源製造商，製造過程非常複雜。

If you want to make more MVA, you got to build new facilities, the process doesn't transfer easily to other facilities, which is the whole basis of our AGE1 platform while we're going to that because the benefits of the AGE1 besides being more productive, it's also a suspensive cell line which will now allow us to implement manufacturing in currently built manufacturing -- back to manufacturing facilities that typically handle suspense and cell line.

如果想要生產更多的 MVA，就必須建造新的設施，這個過程不容易轉移到其他設施，而這正是我們 AGE1 平台的整個基礎，我們之所以這樣做，是因為 AGE1 的好處除了生產率更高之外，它還是一種懸浮細胞系，現在我們可以在目前建造的製造工廠中實施製造——回到通常處理懸浮和細胞系的製造工廠。

So that's how you change the paradigm and supply for these MVAs.

這就是改變這些 MVA 範式和供應的方式。

Okay. The last question, and thank you for taking them. Could you characterize how the collaboration partnership environment looks currently? And then maybe just a mechanistic question, the top line. About $3 million a quarter, is that what we should anticipate until you get to the $26 million or whatever the ultimate number comes to be for the BARDA contract? Thank you very much.

好的。這是最後一個問題，感謝您回答這個問題。您能描述一下目前的合作夥伴關係環境嗎？然後可能只是一個機械問題，第一行。每季約 300 萬美元，這是我們預期的數字，直到達到 2,600 萬美元或 BARDA 合約的最終數字為止？非常感謝。

Mark Reynolds, do you want to touch on the financial first? And then I'll (inaudible).

馬克雷諾茲，您想先談談財務問題嗎？然後我會（聽不清楚）。

Yeah. So the financials, the reimbursement is on the cost reimbursement basis. So we're recording -- the revenue we record is based on just standard personnel time each month with overheads layered on top and the rest will come as the bills, the respective bills come in from manufacturing activities. The clinical trial piece of that is not going to be reflected in our financials. That's through Allucent, the CRO, whp had a direct award from BARDA.

是的。因此，財務方面，報銷是以成本報銷為基礎的。所以我們記錄的收入僅基於每月標準人員時間加上管理費用，其餘部分將作為帳單，相應的帳單來自製造活動。臨床試驗部分不會反映在我們的財務狀況中。這是透過 CRO Allucent 實現的，該公司直接從 BARDA 獲得了獎項。

I'm not sure if that answered the question, Jim.

我不確定這是否回答了這個問題，吉姆。

Just as we're modeling on this, we sort of plug in about $3 million a quarter, roughly going forward until you run through the $26 million.

正如我們對此進行建模一樣，我們每個季度都會投入約 300 萬美元，大致如此，直到我們用完 2600 萬美元。

Yeah, I think that for your model, I think that's a fair approach. It's a little uncertain on our end. But I think that's how I model it for our internal cash flow projections.

是的，我認為對於您的模型，這是一種公平的方法。就我們這邊來說，有點不確定。但我認為這就是我為我們的內部現金流預測建模的方式。

Great. Thank you.

偉大的。謝謝。

And in regard, Jim, regarding the question about the partnering environment, et cetera, I'm going to ask John to weigh in on that because he and I have just returned from several weeks in Europe interacting with people about potential partners, et cetera. So, John?

吉姆，關於合作環境等問題，我將請約翰對此發表看法，因為他和我剛從歐洲回來，在那裡呆了幾個星期，與人們就潛在合作夥伴等進行了交流。那麼，約翰？

The partnering area is still somewhat difficult in the sense that M&A and licensing has been a little bit depressed with everything going on. It's definitely picking up, people are actively engaging with us. They're reaching out to us to talk at the meetings, seeing some significant interest in Gedeptin. And the 04S1 is a little harder for some people to get their hands around because of all the political noise around it.

合作領域仍然有些困難，因為隨著一切進展，併購和授權業務一直有些低迷。它確實在發展，人們正在積極地與我們互動。他們聯繫我們，希望在會議上進行交談，因為他們對 Gedeptin 有濃厚的興趣。而由於周遭的政治噪音，04S1 對某些人來說有點難以取得。

And it's not a big issue with the pandemic's past, but once we can engage them and explain that, yeah, it's passed for the healthy individual but not for the immunocompromised individual. These are still the people at risk. They then begin to engage and understand that there's potentially a commercial opportunity present here for them.

就過去的疫情而言，這不是什麼大問題，但一旦我們能夠與他們溝通，並向他們解釋，是的，這種病毒會傳染給健康的人，但不會傳染給免疫功能低下的人。這些人仍然處於危險之中。然後他們開始參與並了解這裡可能存在商業機會。

So I would say that people are engaging, they are interested in Gedeptin, clearly. 04S1, if we get the chance to tell them the story of where we see it fit, they will engage and like anything else, it's (inaudible) finding that match.

所以我想說，人們顯然對 Gedeptin 很感興趣。04S1，如果我們有機會向他們講述我們認為合適的故事，他們就會參與其中，就像其他任何事情一樣，這就是（聽不清楚）找到匹配。

Awesome, yeah --

太棒了，是的--

I was just going to add, Jim that the -- it was surprising from some quarters to hear of the interest because of the need and the lack of access to mpox vaccine. So to the existing MVA, and so we had people pointing out that in their particular region of the world, their locations, they'd be very interested and have asked us to keep them updated as we progress with the GEO-MVA.

我只是想補充一點，吉姆，由於對 mpox 疫苗的需求和無法獲得疫苗，有些人對這種興趣感到驚訝。對於現有的 MVA，我們讓人們指出，在他們所在的特定地區、他們的位置，他們會非常感興趣，並要求我們在 GEO-MVA 進展過程中向他們通報最新情況。

Yeah, I was thinking too. The (inaudible) are putting $2.3 billion in the quarter of (inaudible) as much as interest may have waned on Wall Street on COVID. COVID hasn't gotten tired of us.

是啊，我也這麼想。(聽不清楚) 本季投入了 23 億美元，儘管華爾街對 COVID 的興趣可能已經減弱。COVID 並沒有厭倦我們。

There's another thing that might be worth mentioning and that is there was a recent publication out of the Fred Hutch that highlighted the fact that the clinical trials for the COVID vaccines have traditionally avoided enrolling immunocompromised patients. And given that the need is so great in that population, there is sort of an increasing momentum to recognize the fact that these patients need to be in clinical trials.

還有另一件事可能值得一提，那就是弗雷德哈金森癌症研究中心最近發表了一篇出版物，強調了一個事實，即 COVID 疫苗的臨床試驗傳統上避免招募免疫功能低下的患者。鑑於該族群的需求如此之大，人們越來越認識到這些患者需要參加臨床試驗的事實。

They need to be offered the opportunity to participate in vaccine trials. And we're hoping that that's going to -- the attention that that's starting to get with the institutions that manage these patients is going to encourage some greater participation on the part of both investigators and patients.

他們需要獲得參與疫苗試驗的機會。我們希望這能引起管理這些患者的機構的關注，從而鼓勵研究人員和患者更多參與。

Thank you for taking the questions.

感謝您回答這些問題。

Jason Kolbert, D. Boral Capital.

Jason Kolbert，D.Boral Capital。

Thanks, guys. A couple of questions. I'm just wondering if you've been watching the launch of Pemgarda and what you think of that because it is -- while it's not a traditional vaccine, it's a monoclonal antibody. It is targeting immunocompromised patients for COVID. And are there any lessons to be learned from that?

謝謝大家。幾個問題。我只是想知道您是否一直在關注 Pemgarda 的推出，以及您對此有何看法，因為雖然它不是傳統疫苗，但它是一種單株抗體。其針對的是免疫功能低下的 COVID 患者。我們可以從中學到什麼教訓嗎？

So I'll ask Kelly, if you'd like to weigh in on that?

所以我想問凱利，你是否願意對此發表意見？

Yeah, we're certainly aware of that, that it was launched. It's clearly offering benefit to these patients. I think it's worth recognizing that monoclonal antibodies are not totally innocuous on the one hand. There are a number of patients that have had bad reactions to those, not necessarily that one but other monoclonal antibodies.

是的，我們當然知道它已經發射了。這顯然為這些患者帶來了益處。我認為值得認識到的是，一方面單株抗體並不是完全無害的。許多患者對這些藥物產生了不良反應，不一定是這一種，而是其他單株抗體。

And the fact that the half life of these antibodies is pretty much restricted by the nature of what they are. And so, one of the advantages that we think we're bringing with our vaccine is by stimulating a strong T cell response. We're enhancing sort of the memory response that these patients will develop to vaccination, and we'll offer them a more prolonged protection against developing severe disease or worse.

事實上，這些抗體的半衰期很大程度上受到其性質的限制。因此，我們認為我們的疫苗的優點之一是能夠刺激強烈的 T 細胞反應。我們正在增強這些患者對疫苗接種的記憶反應，並為他們提供更持久的保護，防止他們患上嚴重疾病或更糟的情況。

So I think Pemgarda is certainly can be viewed as a competitive product in one sense, but it has advantages and disadvantages just like vaccines do.

因此我認為從某種意義上來說，Pemgarda 當然可以被視為一種有競爭力的產品，但它和疫苗一樣，有優點也有缺點。

Yeah, fair enough. I think it's interesting. I think they could actually be complementary in a lot of ways. You did a very good financing in August, particularly when you look at where the stock was then and where it is now. One of the biggest challenges in the micro-cap world is financing. Can you talk a little bit about what the strategy is to kind of get across the next 12 to 24 months where it seems like you have multiple inflection points coming? Thanks.

是的，相當公平。我認為這很有趣。我認為它們實際上在很多方面可以互補。你們八月的融資非常好，特別是當你查看當時的股票價格和現在的股票價格時。小型資本市場面臨的最大挑戰之一是融資。您能否稍微談談未來 12 到 24 個月的策略，在這段期間您似乎將迎來多個轉捩點？謝謝。

Thank you. So, Mark, would you like to pick that up? I'll toss that to you.

謝謝。那麼，馬克，你想接這個嗎？我會把它丟給你。

Yeah, I can't answer the exact strategy, Jason, other than to say that we've got multiple tools in our tool belt now. We've got -- we've recently installed an ATM facility. We've got ongoing conversations with multiple bankers. And we've recently been able to extract ourselves out of the baby shelf restriction for selling (inaudible) under our shelf registration. So we've got a lot of opportunities here to efficiently raise capital with better terms than we've seen in the past and I'll kind of leave it at that.

是的，傑森，我無法回答具體的策略，只能說我們現在的工具帶中有多個工具。我們最近安裝了一台 ATM 設備。我們正在與多位銀行家進行對話。最近，我們已經能夠擺脫嬰兒貨架限制，在我們的貨架註冊下銷售（聽不清楚）。因此，我們有很多機會以比過去更好的條件有效地籌集資金，我就不多說了。

Okay. Fair enough. Thanks so much for the update.

好的。很公平。非常感謝您的更新。

Vernon Bernardino, H.C. Wainwright.

伯納迪諾，H.C.溫賴特。

Hi, David and everyone. Thanks for taking my question and apologize for the graininess of this connection. I just wanted to ask a question about R&D expenses.

嗨，大衛，大家好。感謝您回答我的問題，並對您回答的不夠清楚表示歉意。我只是想問一個關於研發費用的問題。

What cost do you think you may continue to incur regarding manufacturing materials for the clinical trials with 04S1 and the border contract (technical difficulty) and with Oxford Biomedica manufacturing supply for you. Is that something where you -- they manufacture supply and then you pay them? What kind of accounting treatment is used there? And what level of expenses do you incur there?

您認為您可能繼續承擔與04S1臨床試驗的製造材料和邊境合約（技術難度）以及Oxford Biomedica為您提供的製造供應相關的哪些成本。這是你們的做法嗎——他們製造供應品然後你付款給他們？那裡採用什麼樣的會計處理？您在那裡的開支是多少？

Mark, you want to address those?

馬克，你想解決這些問題嗎？

Yeah, I'll try to answer the question as best I can. Our relationship with Oxford Biomedica is we have multiple task orders with them for various different manufacturing campaigns for different products. And it is a -- I won't call it necessarily bill as you go, but there are -- like the standard contract might be 40% up front, 40% on a certain milestone and then 20%.

是的，我會盡力回答這個問題。我們與 Oxford Biomedica 的關係是，我們與他們有多個任務訂單，針對不同產品的各種不同的製造活動。而且它是——我不會稱它為賬單，但是——標準合約可能是預付款 40%，某個里程碑付款 40%，然後付款 20%。

What you see reflected in our financials, we've had some heavy expenses during 2024 for a manufacturing campaign and much of that is going to be behind us now. So we're in a good position. Relative to the material for the BARDA contract, that's going to be fully paid for by BARDA. I mean, we pay for it but it gets reimbursed by Barda. So it's really a wash for us.

從我們的財務狀況來看，我們在 2024 年的製造活動中花費了大量資金，而其中大部分資金現在已經過去了。因此我們處於有利地位。相對於 BARDA 合約的材料，該費用將全額由 BARDA 支付。我的意思是，我們付了錢，但 Barda 會報銷。所以這對我們來說確實是一種洗禮。

Much of that cost is still in front of us. But it really doesn't affect us on a cash flow basis except for a minor bit of working capital needs. Just while we wait on getting reimbursed from BARDA, which is quick. They pay us within 30 days of when we submit the expenses. So I don't know, does that sufficiently answer the question?

大部分成本仍擺在我們面前。但除了少量營運資金需求外，它實際上不會對我們的現金流產生影響。我們目前正在等待 BARDA 的報銷，報銷速度很快。他們在我們提交費用後 30 天內付款給我們。所以我不知道，這是否充分回答了這個問題？

Yeah. Just to clarify those. So if you were to be paid, if you were to incur those expenses this month, you would be paid in December and not in January?

是的。只是為了澄清這些。所以如果您要得到報酬，如果您這個月要產生這些費用，您會在 12 月而不是 1 月得到報酬嗎？

We would probably be paid in January because we bill BARDA on a monthly basis at the end of the month. So our cost incurred in November, for example, if we pay for that right away or even if we don't pay for it, if the expense comes in in November, we submit our invoice to BARDA first week of December, we get paid first week of January.

我們可能會在一月份收到付款，因為我們會在月底按月向 BARDA 收費。例如，如果我們在 11 月產生了費用，如果我們立即支付，或者即使我們不支付，如果費用在 11 月發生，我們會在 12 月的第一周向 BARDA 提交發票，我們會在 1 月的第一周收到付款。

Great. That's very helpful. I appreciate you answering my questions and congrats on the process of -- on the progress. Looking forward to the readouts in the coming weeks.

偉大的。這非常有幫助。感謝您回答我的問題，並對這項進程的進展表示祝賀。期待未來幾週的讀數。

Thank you. Appreciate that.

謝謝。非常感謝。

Robert LeBoyer, Noble Capital Markets.

羅伯特‧勒博耶（Robert LeBoyer），Noble Capital Markets。

Good afternoon and congratulations on a really great quarter. Just wanted to congratulate the whole team on all of the achievements that have been reported in the last quarter and just applaud the progress that you've made in the face of some really difficult times in the past.

下午好，恭喜您度過了一個非常出色的季度。只是想祝賀整個團隊在上個季度取得的所有成就，並讚揚你們在過去一些非常困難的時刻所取得的進步。

My question has to do with Gedeptin and you mentioned in the press release that the Phase 2 will have a single cycle -- will be a single-cycle trial and pathological response rate will be the primary endpoint. I was curious if you could expand a little bit about the treatment and whether a single-cycle trial means single cycle of Gedeptin and standard dosing of the checkpoint inhibitor for one single cycle of each? And if there were any specific pathological response endpoints that you could share at this point?

我的問題與 Gedeptin 有關，您在新聞稿中提到，第 2 階段將有一個單週期試驗——將是單週期試驗，病理反應率將是主要終點。我想知道您是否可以稍微詳細說明一下治療方法，以及單週期試驗是否意味著 Gedeptin 單週期和檢查點抑制劑標準劑量各一個週期？此時您可以分享任何具體的病理反應終點嗎？

Thank you. Kelly?

謝謝。凱莉？

Yeah, I'll do my best. We have a clinical oncologist on staff that's been sort of driving the design and prosecution of this program. So where we are is, the single cycle refers to the single cycle of Gedeptin. The study will actually involve a cycle of Gedeptin plus, which is Ad/PNP plus fludarabine, along with a single cycle of pembrolizumab that will be followed by another cycle of pembrolizumab then followed by surgery, surgical resection of the tumor and observation for effect.

是的，我會盡力。我們有一個臨床腫瘤學家團隊，負責推動這個計畫的設計和實施。所以我們現在的單週期是指 Gedeptin 的單週期。研究實際上將涉及一個 Gedeptin 加療程，即 Ad/PNP 加氟達拉濱，以及一個療程的 pembrolizumab，然後再進行另一個療程的 pembrolizumab，然後進行手術、手術切除腫瘤並觀察效果。

So it's again -- to answer your question directly, it's a single cycle of Gedeptin plus pembro, but they're actually going to be two rounds of pembro given prior to surgical resection.

因此，再次直接回答您的問題，這是一個 Gedeptin 加 pembro 的單週期治療，但實際上在手術切除之前會進行兩輪 pembro 治療。

Now the end points, we're looking for complete response, but we're also going to be monitoring for all sort of levels of pathological response. Our comparator is a recently completed trial with -- that looked at pembro alone as is neoadjuvant treatment for this class of patients in which there was essentially no complete responses seen. So we think we've got a pretty good shot at demonstrating something that's better than what the current standard offers in that regard.

現在，我們尋求的最終目標是完全緩解，但我們也將監測各種程度的病理反應。我們的對照試驗是一項最近完成的試驗，該試驗單獨研究了派姆單抗作為新輔助治療對這類患者的作用，結果基本上沒有看到完全緩解。因此，我們認為我們很有可能展示出比當前標準在這方面提供的更好的東西。

Okay, great. That's very helpful. Thank you.

好的，太好了。這非常有幫助。謝謝。

Karen Goldfarb, Crystal Research.

凱倫‧戈德法布 (Karen Goldfarb)，水晶研究公司。

Thank you. It's actually Jeffrey Kraws. I wanted to ask -- four of my questions have already been answered, but I wanted to ask: with the durability, because obviously immunocompromised patients, we've addressed this before. There's so many immunocompromised patients and immunocompromised children out there. When you go to run your test for not only your clinical trials, the push to include immunocompromised patients, how big of an effort is that on your behalf?

謝謝。其實就是 Jeffrey Kraws。我想問——我的四個問題已經得到解答了，但我想問：關於耐用性，因為顯然免疫功能低下的患者，我們之前已經解決過這個問題。世上有許多免疫功能低下的患者和免疫功能低下的兒童。當您不僅為臨床試驗進行測試，而且還推動將免疫功能低下的患者納入其中時，您付出了多大的努力？

And the second part is obviously, across all the vaccine platforms you're working on, durability and having the differentiation of having T cells activated and having the T cells educated and learned to go after the virus as it replicates. How long do you plan on conducting those studies in length to try and show that your product is more durable?

第二部分顯然是，在您正在研究的所有疫苗平台上，耐久性和分化性，激活 T 細胞，並教育和學會在病毒複製時追蹤病毒。您計劃進行多長時間的研究來證明您的產品更耐用？

Kelly, do you want to answer?

凱利，你想回答嗎？

Sorry, I had to get myself off on mute. So to answer your first question, our immunocompromised patient population is really our primary patient population target for CM04S1. And that's where we put the majority of our effort beside the BARDA trial obviously, in our development programs. The durability question, in an ideal world, what we'd like to see is being able to reliably measure durability over at least a one-year period. And we're following all of our patients in our trials for one year after following their first dose of vaccine.

抱歉，我不得不靜音。因此，回答您的第一個問題，我們的免疫功能低下的患者群體實際上是 CM04S1 的主要患者群體目標。顯然，除了 BARDA 試驗之外，我們還將大部分精力投入到我們的開發項目中。關於耐用性問題，在理想世界中，我們希望看到的是能夠在至少一年的時間內可靠地測量耐用性。在試驗中，我們會對所有接種第一劑疫苗的患者進行為期一年的追蹤。

What complicates that is the virus continues to sort of be very prevalent globally and there continue to be ongoing infections in these patients. And so, when we're trying to differentiate a natural infection from a vaccine-induced immune response, and immune response from a natural infection from that induced by vaccines and patients that are getting infected throughout the course of follow-up, it becomes very difficult.

讓情況更加複雜的是，這種病毒在全球範圍內仍然非常流行，這些患者仍在持續感染。因此，當我們試圖區分自然感染與疫苗引起的免疫反應、自然感染的免疫反應與疫苗引起的免疫反應以及在整個追蹤過程中被感染的患者時，變得非常困難。

And so, we're very interested in the -- we know we're seeing breakthrough infections. We're not seeing any severe breakthrough infections to date. And we're very interested in following the intensity of infections that that will be occurring in these patients. But trying to sort of sort that out or immunologically is kind of a challenge for us, but we're working on that and we're trying to come up with some workarounds.

因此，我們非常感興趣——我們知道我們正看到突破性感染。到目前為止我們還沒有發現任何嚴重的突破性感染。我們非常有興趣追蹤這些患者的感染強度。但嘗試從免疫學角度解決這個問題對我們來說是一種挑戰，但我們正在努力並試圖找到一些解決方案。

Great, appreciate that. And the last question I have is referring earlier to the 10,000-patient study. We were talking about, we weren't sure when the first patient is going to be enrolled. When you look at the timetable after the first patient is rolled, what is the timetable that you have right now that you're planning to see to get those 10,000 patients all enrolled?

非常好，非常感謝。我的最後一個問題與之前提到的 10,000 名患者的研究有關。我們正在討論，我們不確定什麼時候會招募第一位患者。當您查看第一位患者入院後的時間表時，您目前的時間表是怎樣的？

The current thinking is that we'll get all those assuming we start this trial, when we think we're going to start this trial, which is again, beginning of October 2025. We should be able to enroll this -- fully enroll this study within six months. That's the discussion that we have with our CRO, Allucent, as well as with BARDA. And that's kind of where we're thinking.

目前的想法是，我們將在假設開始這項試驗的情況下獲得所有這些信息，我們認為開始這項試驗的時間是 2025 年 10 月初。我們應該能夠在六個月內完成這項研究。這是我們與 CRO、Allucent 以及 BARDA 進行的討論。這正是我們的想法。

Great. Thank you very much and thank you for the transparency, it's appreciated.

偉大的。非常感謝，感謝您的透明度，我們深表感謝。

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

謝謝。我們的問答環節到此結束。我想將會議交還給戴維·多德 (David Dodd) 來做結束語。

I want to thank everybody for participating in today's update and also especially, members of our team who've been so helpful in answering these questions. But we've had the opportunity to review our achievements, our progress, as well as our outlook.

我要感謝大家參與今天的更新，特別是感謝我們團隊的成員在回答這些問題時提供的幫助。但我們有機會回顧我們的成就、進步以及前景。

We strongly believe that Q3 represented continued and significant progress in the GeoVax development, as a result of the Project NextGen Award, our decision to proceed with an expanded cadet and Phase 2 clinical trial, and our progress with GEO-MVA as well as the advanced MVA manufacturing process. These are our priorities. These represent our focus.Your interest is greatly appreciated, and we look forward to ongoing interactions.

我們堅信，第三季代表了 GeoVax 開發的持續和重大進展，這是 NextGen 計畫獎的結果，我們決定進行擴大學員和第 2 階段臨床試驗，以及我們在 GEO-MVA 以及先進的 MVA 製造流程方面取得的進展。這些是我們的優先事項。這些代表了我們的重點。

As always, I'd like to acknowledge and thank the GeoVax Board of Directors and advisors, our entire GeoVax staff, and the many other parties that continue to support us towards achieving success. We remain 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.

像往常一樣，我要感謝 GeoVax 董事會和顧問、全體 GeoVax 員工以及繼續支持我們成功的許多其他方。我們始終致力於為具有高度競爭力、注重品質的人才提供有意義的職業發展機會，以打破當前的癌症治療和傳染病疫苗模式。

We like doing that. 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 is 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.

我們喜歡這麼做。我們為我們的團隊感到無比自豪和感激，包括那些繼續為 GeoVax 的進步和成功做出貢獻的外部合作夥伴。對我們所有人來說，為我們的股東服務並成為這個團隊的一員是一種莫大的榮譽。我們的首要目標是透過開發和商業化新型、急需的癌症療法和傳染病疫苗來改善全世界的生活。

But today, have a safe and enjoyable day and thank you again for your support and interest.

但今天，祝您度過安全愉快的一天，再次感謝您的支持與關注。

The conference is now concluded. Thank you for attending today's presentation. You may now disconnect.

會議現已結束。感謝您參加今天的演講。您現在可以斷開連線。