GeoVax Labs Inc (GOVX) 2025 Q1 法說會逐字稿

完整原文

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  • Operator

    Operator

  • Good afternoon and welcome everyone to the GeoVax first quarter 2025 corporate update call. My name is Michelle and I'll facilitate today's call.

    下午好,歡迎大家參加 GeoVax 2025 年第一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。

  • With me are David Dodd, Chairman and CEO; Mark Reynolds, Chief Financial Officer; Mark Newman, Chief Scientific Officer; Kelly McKee, Chief Medical Officer; and John Sharkey, Vice President, Business Development.

    和我一起的是董事長兼首席執行官戴維·多德 (David Dodd);馬克·雷諾茲,首席財務官;馬克·紐曼,首席科學官;凱利·麥基 (Kelly McKee),首席醫療官;以及業務發展副總裁 John Sharkey。

  • (Operator Instructions) As a reminder, this conference is being recorded. At this time, I’ll turn 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,我將把電話轉給 Precision AQ 的 Max Gadicke。

  • Max Gadicke - Investor Relations

    Max Gadicke - Investor Relations

  • 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.

    謝謝,請注意以下內容。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。

  • Actual results may differ materially from those included in these statements due to a variety of factors, including weather: GeoVax can develop and manufacture its product candidates with the desired characteristics in a timely manner and such products are 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. 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.

    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 可以及時開發和製造具有所需特性的產品候選物,並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。正在開發的競爭產品可能比 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 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. It is now my pleasure to introduce the Chairman and CEO of GeoVax, David Dodd.

    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資​​訊包含在 GeoVax 向美國證券交易委員會提交的文件中,包括 GeoVax 10-K 表格中的風險因素中列出的資訊。現在我很高興介紹 GeoVax 董事長兼執行長 David Dodd。

  • David Dodd - Chairman of the Board, President, Chief Executive Officer

    David Dodd - Chairman of the Board, President, Chief Executive Officer

  • Thank you. Welcome to the first quarter of 2025 GeoVax corporate update call. 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。歡迎參加 2025 年第一季 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 (Mark Reynolds) 將提供我們的財務狀況更新,然後我們將解答您可能遇到的任何問題。

  • We remain confident in the continued progress and compelling outlook for our portfolio of GEO-CM04S1, GEO-MVA, Gedeptin and the advanced MVA manufacturing process.

    我們對 GEO-CM04S1、GEO-MVA、Gedeptin 和先進的 MVA 製造流程的產品組合的持續進步和強勁前景充滿信心。

  • Each of our product development candidates addresses critically important unmet healthcare needs, providing opportunities for expedited registration paths and strong opportunities to commercialize differentiated solutions supporting patient needs worldwide.

    我們的每款產品開發候選產品都解決了至關重要的未滿足的醫療保健需求,為加快註冊途徑提供了機會,並為商業化支持全球患者需求的差異化解決方案提供了強大的機會。

  • We also anticipate that the advanced MVA manufacturing process will provide a gain advantage in production of MVA-based vaccines and therapies.

    我們也預計,先進的 MVA 製造流程將在基於 MVA 的疫苗和療法的生產中帶來優勢。

  • We also wish to welcome Dr. Cynthia Ranganathan to GeoVax access our Vice President technical Development and CMC operations, joining our team to guide our transition to the next phase towards registration and commercialization of our exciting portfolio.

    我們也歡迎 Cynthia Ranganathan 博士加入 GeoVax,擔任我們的技術開發和 CMC 營運副總裁,加入我們的團隊,指導我們過渡到下一階段,以實現我們令人興奮的產品組合的註冊和商業化。

  • Before going any further, let me first address the recent project NextGen stop work order.

    在進一步討論之前,讓我先談談最近的 NextGen 專案停工令。

  • Following the close of the first quarter on April 11th, we unexpectedly received the stop work order notice relative to the BARDA Project NextGen program. The notice indicated that BARDA has decided to terminate the contract for convenience to the government pursuant to the terms of the project agreement. We can only assume this relates to the ongoing government efficiency efforts.

    4月11日第一季結束後,我們意外收到了與BARDA Project NextGen計畫相關的停工令通知。通知指出,BARDA已根據項目協議條款決定終止合同,以方便政府。我們只能假設這與政府正在進行的效率努力有關。

  • We had no prior indication that the notice was forthcoming and we're surprised by the notices. Both the GeoVax internal team, our external contractors and consultants were making good progress and had a very good productive working relationship with the technical team at BARDA.

    我們事先沒有任何跡象表明會收到該通知,我們對這些通知感到驚訝。GeoVax 內部團隊、我們的外部承包商和顧問都取得了良好的進展,並與 BARDA 的技術團隊建立了非常良好且有效率的工作關係。

  • The termination in no way implies any concerns as to the safety or potential efficacy of GEO-CM04S1 or the underlying MDA vaccine vector technology, nor will the termination impact the ongoing Phase 2 clinical trials of CMO4S1, primarily investigating our vaccine and immunocompromised patient populations.

    終止絕不意味著對 GEO-CM04S1 或底層 MDA 疫苗載體技術的安全性或潛在有效性有任何擔憂,也不會影響正在進行的 CMO4S1 第 2 階段臨床試驗,該試驗主要研究我們的疫苗和免疫功能低下的患者群體。

  • The funding from BARDA pursuant to the project agreement was mostly earmarked for incremental spending, with a large portion going directly to the external clinical research organization to conduct a clinical trial. Given the structure of the award, the financial impact of GeoVax is estimated at less than $750,000 annually toward reimbursement of existing personnel overhead costs.

    根據計畫協議,BARDA 提供的資金主要用於增量支出,其中很大一部分直接用於外部臨床研究組織進行臨床試驗。考慮到獎項的結構,GeoVax 的財務影響估計每年不到 75 萬美元,用於償還現有人員管理費用。

  • As a result, we don't anticipate any significant changes to our ongoing operations. The decision by BARDA to terminate our contract is very disappointing to GeoVax and our stakeholders. However, we remain committed to CMO4S1 as a critically needed next generation multi-antigen COVID-19 vaccine, providing the potential for 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.

    因此,我們預計我們正在進行的業務不會發生任何重大變化。BARDA 終止我們合約的決定讓 GeoVax 和我們的利害關係人非常失望。然而,我們仍然致力於將 CMO4S1 作為急需的下一代多抗原 COVID-19 疫苗,它有可能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 疫苗相比具有更高的持久性,特別是在解決免疫系統受損患者的免疫保護方面。

  • During the Q&A session, we welcome the opportunity to address any further questions that you may have.

    在問答環節,我們歡迎有機會解答您可能有的任何其他問題。

  • Our current CMO4S1 studies will continue, especially our focus on achieving the completion of the investigator initiated Phase 2 trial among chronic lymphocytic leukemia patients, one of the highest risk groups in the need of reducing the risk of severe infection, hospitalization, the risk of death coming from COVID-19.

    我們目前的 CMO4S1 研究將繼續進行,特別是我們將重點放在研究者發起的針對慢性淋巴細胞白血病患者的 2 期試驗,該患者是需要降低嚴重感染風險、住院風險和 COVID-19 死亡風險的最高風險人群之一。

  • Demonstrating the potential superior value of CMO4S1 among immunocompromised patients remains our focus for the development of differentiation for the first generation and other single antigen focused COVID-19 vaccines.

    證明 CMO4S1 在免疫功能低下患者中的潛在卓越價值仍然是我們開發第一代和其他單一抗原針對的 COVID-19 疫苗的差異化重點。

  • The medical need for a COVID-19 vaccine such as CMO4S1 is substantial given that we estimate over 40 million adults in the United States have medical conditions rendering their immune systems inadequately responsive to the first generation and other single antigen vaccine.

    鑑於我們估計美國有超過 4000 萬成年人患有疾病,導致他們的免疫系統對第一代和其他單一抗原疫苗的反應不足,因此對 CMO4S1 等 COVID-19 疫苗的醫療需求是巨大的。

  • Worldwide, we estimate over 400 million at such risk. In addition, we believe the CMO4S1 provides the potential for a better booster for the first generation single antigen vaccines.

    我們估計,全世界有超過 4 億人面臨這種風險。此外,我們相信 CMO4S1 有可能成為第一代單一抗原疫苗更好的加強劑。

  • During 2025, we anticipate multiple presentations of clinical results for CMO4S1, including the World Vaccine Congress presentation last week.

    2025 年,我們預計將多次展示 CMO4S1 的臨床結果,包括上週的世界疫苗大會展示。

  • In addition, presentations are scheduled for the European Hematology Association, the International Workshop on Chronic Lymphocytic Leukemia, the American Association of Immunologists, the Keystone Vaccinology, and the additional conferences underscoring the important potential medical value of this unique next generation COVID-19 vaccine.

    此外,還將在歐洲血液學協會、慢性淋巴細胞白血病國際研討會、美國免疫學家協會、Keystone疫苗學和其他會議上發表演講,強調這種獨特的下一代COVID-19疫苗的重要潛在醫療價值。

  • These presentations will undoubtedly also serve as an important catalyst for ongoing strategic partnership discussions.

    這些演講無疑也將成為正在進行的策略夥伴關係討論的重要催化劑。

  • Relative to GEO-MVA, our vaccine candidate against Mpox and smallpox, we recently completed CGMP production and quality release of the clinical batch of vaccine material. We anticipate having vaccine available for clinical evaluation later this year.

    相對於我們針對 Mpox 和天花的候選疫苗 GEO-MVA,我們最近完成了疫苗材料臨床批次的 CGMP 生產和品質放行。我們預計今年稍後將有疫苗可供臨床評估。

  • We're pleased to state that we have produced sufficient amount of product to support the anticipated clinical evaluation, as well as additional product in support of additional clinical use in conjunction with various stakeholder discussions that we have underway.

    我們很高興地宣布,我們已經生產了足夠數量的產品來支持預期的臨床評估,以及結合我們正在進行的各種利益相關者討論來支持額外臨床使用的額外產品。

  • 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. Over the remainder of 2025, we look forward to providing additional updates on our progress with this vaccine.

    我們相信,GEO-MVA 有可能結束目前 MVA 疫苗供應的壟斷,擴大這種急需疫苗的全球供應,既能滿足疫情爆發帶來的需求,又能滿足世界各地的各種儲備機會。在 2025 年剩餘的時間裡,我們期待提供有關該疫苗進展的更多更新資訊。

  • Relative to our plans for a Phase 2 Gedeptin trial on head and neck cancer, the clinical operations plans are underway as we complete the necessary regulatory aspects of product manufacturing in support of the trial. Just this week, Dr. Mark Py has presented at the AACR meeting in Chicago reviewing the clinical results thus far and our plans for the Phase 2 study.

    相對於我們針對頭頸癌進行 Gedeptin 第 2 階段試驗的計劃,臨床運營計劃正在進行中,我們正在完成支持試驗的產品製造所需的監管方面。就在本週,Mark Py 博士在芝加哥舉行的 AACR 會議上回顧了迄今為止的臨床結果以及我們第二階段研究的計劃。

  • In addition to the upcoming Phase 2 trial, we also plan additional studies of Gedeptin addressing other solid tumors beyond head and neck cancer. We believe that Gedeptin has the potential to address multiple solid tumors, especially via combination therapy, providing significant value long term.

    除了即將進行的第二階段試驗外,我們還計劃對 Gedeptin 治療頭頸癌以外的其他實體腫瘤進行更多研究。我們相信 Gedeptin 具有治療多種實體腫瘤的潛力,尤其是透過聯合療法,可帶來長期的巨大價值。

  • 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 establishing business partnerships and collaborations in support of the worldwide development, commercialization, and distribution of our portfolio products.

    總體而言,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,尋求支持快速註冊途徑的初步適應症。我們期待建立商業夥伴關係和合作關係,以支持我們產品組合的全球開發、商業化和分銷。

  • Our priorities and anticipated milestones for 2025 remain focused on, one or first advancing GEO-CM04S1 for immune compromised populations. Secondly, advancing GEO-MVA to clinical evaluation.

    我們對 2025 年的首要任務和預期里程碑仍然集中於為免疫功能低下人群開發一款或首款 GEO-CM04S1。其次,將GEO-MVA推進到臨床評估階段。

  • I'll note the significant governmental interests exists relative to the US-based supply chain versus the current overdependence on non-US suppliers. The strong sentiment in favor of such onshoring initiatives remains a major national legislative focus and interest. We remain in active discussions and briefings with various stakeholders such as the White House, congressional representatives, HHS, BARDA, WHO, the AFCA CDC, and others regarding our having produced a CGMP clinical batch of GEO-MVA vaccine planned for use in the upcoming clinical study, as well as other potential uses.

    我要指出的是,相對於目前對非美國供應商的過度依賴,美國供應鏈中存在著重大的政府利益。對此類在岸化措施的強烈支持仍然是國家立法的一大焦點和關注點。我們仍在與白宮、國會議員、衛生與公眾服務部、生物醫學高級研究與發展局、世界衛生組織、美國空軍臨床與臨床管理局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,討論我們已生產出一批符合 CGMP 標準的 GEO-MVA 臨床疫苗,計劃用於即將進行的臨床研究以及其他潛在用途。

  • In fact, WHO and other stakeholders have underscored the critical need for expanded Mpox vaccine supply as a priority for WHO and other public health agencies worldwide.

    事實上,世衛組織和其他利害關係人已強調擴大 Mpox 疫苗供應的迫切需要,這是世衛組織和世界其他公共衛生機構的優先事項。

  • Lastly, our focus on oncology, specifically related to Gedeptin is a major priority for the future of GeoVax. We have high expectations for the potential broad utilization of Gedeptin against various solid tumors, especially in combination with immune checkpoint inhibitors.

    最後,我們對腫瘤學的關注,特別是與 Gedeptin 相關的腫瘤學,是 GeoVax 未來的主要優先事項。我們對 Gedeptin 對抗各種實體腫瘤的潛在廣泛應用抱有很高的期望,尤其是與免疫檢查點抑制劑合併使用。

  • We continue to progress towards the invitation of our Phase 2 study to evaluate Gedeptin in combination with the immune checkpoint inhibitor among patients with locally recurrent head and neck squamous cell carcinomas following primary therapy and for whom resection with curative intent is planned.

    我們繼續推進 2 期研究的邀請,以評估 Gedeptin 與免疫檢查點抑制劑聯合治療在接受初次治療後局部復發的頭頸部鱗狀細胞癌患者,併計劃進行治愈性切除術。

  • Our clinical operations plans for this trial I mentioned are coming together nicely along with the regulatory aspects and necessary product manufacturing and support of the Phase 2 study.

    我提到的針對此次試驗的臨床營運計劃與第二階段研究的監管方面以及必要的產品製造和支援進展順利。

  • As I previously noted, this week, Dr. Pike has provided an overview of Gedeptin of the American Association of Cancer Research. In addition, we're planning various animal validation studies, further building a compelling basis of the potential value of Gedeptin addressing various solid tumors.

    正如我之前提到的,本週,派克博士對美國癌症研究協會的 Gedeptin 進行了概述。此外,我們正在計劃進行各種動物驗證研究,進一步為 Gedeptin 治療各種實體腫瘤的潛在價值奠定令人信服的基礎。

  • Overall 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.

    總的來說,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上,同時提供至關重要的差異化產品,以改善全世界的生活。

  • 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,我想將演講交給 GeoVax 財務長馬克雷諾茲 (Mark Reynolds),讓他回顧我們最近的表現和財務狀況,馬克。

  • Mark Reynolds - Chief Financial Officer, Corporate Secretary

    Mark Reynolds - Chief Financial Officer, Corporate Secretary

  • Thank you, David. The details of our first quarter, 2025 financial results are summarized in today's press release. I'll start my review with our income statement.

    謝謝你,大衛。我們的 2025 年第一季財務業績詳情已在今天的新聞稿中進行了總結。我將從我們的損益表開始我的審查。

  • Revenues associated with the BARDA contract were $1.6 million in 2025 versus zero in 2024 as the contract began during June of last year. As David mentioned, we received a stop work order from BARDA in April with the expectation that the contract is to be terminated.

    由於該合約於去年 6 月開始生效,因此 2025 年 BARDA 合約相關收入為 160 萬美元,而 2024 年則為零。正如戴維所提到的,我們在四月收到了 BARDA 的停工命令,預計合約將被終止。

  • So there will be a final settlement amount built to BARDA during Q2 of this year, and then nothing more going forward. But as a reminder, this is a cost reimbursement contract with the vast majority of the contract earmarked for new incremental spending. So the net financial impact to GeoVax is expected to be less than $750,000 annually for a billable personnel time and overhead. Research and development expenses were $5.4 million in 2025 versus $4.4 million in 2024, representing an increase of roughly $1 million or 21%.

    因此,我們將在今年第二季向 BARDA 支付最終結算金額,之後將不再進行任何結算。但需要提醒的是,這是一份成本補償合同,其中絕大部分資金專門用於新的增量支出。因此,預計 GeoVax 每年因可計費人員時間和間接費用而產生的淨財務影響將不到 75 萬美元。2025 年研發費用為 540 萬美元,而 2024 年為 440 萬美元,增加約 100 萬美元,增幅為 21%。

  • The increase during '25 is primarily related to costs associated with the BARDA contract, as well as our Gedeptin and GEO-MVA programs. These costs were partially offset by lower costs related to the CMO4S1 clinical trial.

    25 年期間的成長主要與 BARDA 合約相關的成本以及我們的 Gedeptin 和 GEO-MVA 計劃有關。這些成本被 CMO4S1 臨床試驗相關的較低成本部分抵銷。

  • General administrative expenses were $1.7 million in 2025 versus $1.5 million in 2024, representing an increase of $200,000 or 16% associated with higher investor relations, consulting costs, and stock-based compensation expense.

    2025 年一般行政費用為 170 萬美元,而 2024 年為 150 萬美元,增加了 20 萬美元或 16%,原因是投資者關係、諮詢費用和股票薪酬費用增加。

  • Interest income was $47,000 in 2025 compared with $33,000 in 2024. So overall net loss for the first quarter of 2025 was approximately $5.4 million or $0.45 per share versus $5.9 million in 2024 or $2.47 per share.

    2025 年利息收入為 47,000 美元,而 2024 年為 33,000 美元。因此,2025 年第一季的整體淨虧損約為 540 萬美元或每股 0.45 美元,而 2024 年為 590 萬美元或每股 2.47 美元。

  • Turning now to the balance sheet, our cash balances at March 31st were $7.4 million as compared to $5.5 million at December 31st, reflective of $6 million used in operating activities all set by $7.9 million in financing transactions. Our outstanding common shares currently stand at $15.2 million following recent financing activity.

    現在來看看資產負債表,我們 3 月 31 日的現金餘額為 740 萬美元,而 12 月 31 日的現金餘額為 550 萬美元,其中經營活動中使用的 600 萬美元全部由融資交易中的 790 萬美元決定。經過最近的融資活動,我們目前已發行的普通股價值為 1,520 萬美元。

  • Including the ongoing GEO-CM04S1clinical trials continues to be a top priority for us in terms of our operational focus. These trials were unaffected by the BARDA stop work order. We also expect to accelerate our plans for clinical trials associated with the GEO-MVA, and Gedeptin programs. Supporting these clinical programs will be the most significant use of our cash in the foreseeable future.

    就我們的營運重點而言,正在進行的 GEO-CM04S1 臨床試驗仍然是我們的首要任務。這些試驗並未受到 BARDA 停工令的影響。我們也希望加快與 GEO-MVA 和 Gedeptin 計畫相關的臨床試驗計畫。在可預見的未來,支持這些臨床項目將是我們資金最重要的用途。

  • We continue to explore various strategies to fund our development programs through several evaluation inflection points and to extend our cash runway. These could come in the form of strategic partnerships, non-diluted funding, and additional offerings of our common stock.

    我們將繼續探索各種策略,透過幾個評估轉折點為我們的開發項目提供資金並延長我們的現金跑道。這些可能以策略夥伴關係、非稀釋融資和普通股額外發行的形式出現。

  • I'll be happy to answer any questions during the Q&A, and now I'll turn the call back over 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。

  • David Dodd - Chairman of the Board, President, Chief Executive Officer

    David Dodd - Chairman of the Board, President, Chief Executive Officer

  • Thank you, Mark. My colleagues and I will now answer your questions. 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. I'll now turn the call over to the operator for instructions on the question answer period.

    謝謝你,馬克。我和我的同事現在就來回答大家的問題。參加問答環節的有我們的首席科學官 Mark Newman 醫師、首席醫療官 Kelly McKee 醫師和業務發展副總裁 John Sharkey 醫師。我現在將把電話轉給接線員,請接線生提供問答環節的指示。

  • Operator

    Operator

  • Thank you. We will now begin the question and answer session. To ask a question.

    謝謝。我們現在開始問答環節。提出一個問題。

  • (Operator Instructions)

    (操作員指示)

  • And our first question comes from James Malloy with Alliance Global Partners. Your line is open.

    我們的第一個問題來自 Alliance Global Partners 的 James Malloy。您的線路已開通。

  • James Molloy - Analyst

    James Molloy - Analyst

  • Hey guys, thank you very much for taking my question. I want to address, I'm sure you saw that Vaxart recently got their hold lifted. I was wondering if you could talk a little bit about that if any compare or contrast potentially between, their program, your program, is that a hopeful sign for potentially, a change in the thinking of the administration with the stop work order.

    嘿夥計們,非常感謝你們回答我的問題。我想說的是,我相信你已經看到 Vaxart 最近被解除了控制。我想知道您是否可以稍微談談這個問題,如果他們的計劃和您的計劃之間有任何潛在的比較或對比,這是否是一個充滿希望的信號,表明政府在停工令方面的想法可能會發生改變。

  • David Dodd - Chairman of the Board, President, Chief Executive Officer

    David Dodd - Chairman of the Board, President, Chief Executive Officer

  • Hey James, thank you. This is David and I'll be happy to address that. There's some distinct differences between their program and ours. First of all, Vaxart had already dosed 400 patients, if you may recall that. So they had a 400 patient sentinel group out of the 10,000. That was what was halted in February they received notice I believe it was February 21st and so the situation they had was you had a group of patients out there already dosed, this was also true with another company which is a private company that had just started their clinical trial. There are actually two such holds issued back stop work quarters and in February.

    嘿,詹姆斯,謝謝你。我是大衛,我很樂意回答這個問題。他們的計劃和我們的計劃之間存在一些明顯的差異。首先,如果您還記得的話,Vaxart 已經為 400 名患者進行了給藥。因此,在 10,000 名患者中,他們有 400 名是耐心的哨兵組。這就是 2 月停止的事情,他們收到通知,我記得是在 2 月 21 日,所以他們的情況是,有一組病人已經服藥了,另一家公司也是如此,這是一家剛開始臨床試驗的私人公司。實際上,早在季度末和二月就已發布過兩次這樣的停工令。

  • One we know much more about because it's a public company, that's facts are. So the challenge that they had and that the government had is you've got pay of the crowd who have been dosed and you can't just leave them out there necessarily without doing something, and so they took the time they evaluated, you may recall that stop work order indicated there would be a 90 day pause in which the government would review the situation and get back by the end of the 90 days, that would have been around the 20th or thereabouts of May.

    因為它是一家上市公司,所以我們對它了解更多,事實就是如此。因此,他們和政府面臨的挑戰是,你必須支付那些已經服藥的人群的費用,你不能只是把他們留在外面而不採取任何措施,所以他們花了一些時間進行評估,你可能還記得,停工令表明將有 90 天的暫停期,政府將在此期間審查情況並在 90 天結束前恢復,大約在 5 月 20 日左右。

  • As it was, the termination was made to then reinstitute and start that program over. So I just want to underscore that in the case of two of the companies of the six vaccines that were in Project NextGen, two of them were already dosing patients. And both of them will received a stop work order. At least one of them that we know about because they made the the public disclosure has, it has been lifted and they'll then go forward.

    事實上,終止該計劃是為了重新開始該計劃。因此,我只想強調一下,就 NextGen 計畫中六種疫苗的兩家公司而言,其中兩家已經開始為患者接種疫苗。他們兩人都將收到停工令。我們知道其中至少有一個,因為他們已經公開披露,禁令已經解除,他們將繼續前進。

  • I also point out that of the six vaccines that had been given the Project NextGen awards of those. You had Vaxart, the other private company, CastleVax is a private company. It remains on a stop work order as we do. And also you had Gritstone which ended up filing bankruptcy, so it's no longer in the program.

    我還指出,在獲得下一代計劃獎的六種疫苗中,有六種是其中之一。你有另一家私人公司 Vaxart,CastleVax 也是一家私人公司。與我們一樣,該公司仍處於停工令狀態。另外,Gritstone 最終也申請破產,因此不再參與該計劃。

  • The only one in which there's little information that we've been able and others have been able to find is Codegenics, which is again a private company so it's hard to find out what I don't, I would not try to guide anyone on what to read into this, we posted our statement on our website. I commented some today. We believe some element of government efficiency because there were no negative reasons that we could determine or that were conveyed to us of why the stop work order occurred, of course we have seen the announcement of $500 million going from BARDA now for a work towards a universal influenza vaccine and a universal coronavirus vaccine.

    我們和其他人能夠找到的唯一信息很少的是 Codegenics,這又是一家私營公司,所以很難找出我不知道的信息,我不會試圖指導任何人閱讀這篇文章,我們在我們的網站上發布了我們的聲明。我今天評論了一些。我們相信這其中有政府效率的因素,因為我們無法確定任何負面原因,也沒有人向我們傳達停工令的執行原因,當然,我們已經看到生物醫學高級研究與發展局 (BARDA) 宣布撥款 5 億美元用於研製通用流感疫苗和通用冠狀病毒疫苗。

  • We don't know if some of that money came from what was in our award or what. I would point out that in September of 2023 vaccines insights was a very well received publication from our R&D team of the universal coronavirus vaccine and certainly we have been positioning that and more recently there was a publication in vaccines peer reviewed journal of a multi-antigen a couple of additional constructs we have that are multi-antigens that could be the candidates for universal pan coronavirus vaccine.

    我們不知道這些錢是否來自我們的獎金或其他什麼。我想指出的是,2023 年 9 月,我們的研發團隊發表了一篇關於通用冠狀病毒疫苗的非常受歡迎的出版物《疫苗洞察》,當然我們一直在定位這一點,最近在疫苗同行評審期刊上發表了一篇關於多抗原的出版物,我們還有一些額外的多抗原構建體,它們可能是通用冠狀病毒疫苗的候選者。

  • So I would just leave it that, but I can't really guide you on what to read into this. So we, made our announcement. All we know is what has been communicated to us and we're focused on running the company and not trying to read too much into convince that may happen. I hope that help answer your question if you have any follow up, just go ahead and ask that.

    所以我就不說了,但我無法真正指導你該讀什麼。因此,我們發布了公告。我們所知道的只是傳達給我們的訊息,我們專注於經營公司,而不是試圖過度解讀可能發生的事情。我希望這能幫助您回答問題,如果您有任何疑問,請繼續詢問。

  • James Molloy - Analyst

    James Molloy - Analyst

  • No, absolutely, of course, let's see what happens. Maybe, just one quick comment as well on the recent, comments by, the head of HHS about, placebo control vaccine trials. Does that impact, your thoughts for your trials going forward and change to design, or we'll see if it even comes to pass.

    不,絕對的,當然的,讓我們看看會發生什麼。也許,我只是想對衛生與公眾服務部負責人最近關於安慰劑對照疫苗試驗的評論做一個簡短的評論。這是否會影響您對未來試驗的想法以及設計的改變,或者我們會看看它是否會實現。

  • David Dodd - Chairman of the Board, President, Chief Executive Officer

    David Dodd - Chairman of the Board, President, Chief Executive Officer

  • Well, we have three Phase 2 trials underway.

    嗯,我們正在進行三項第二階段試驗。

  • One has been completed, which is the Healthy volunteers where we're evaluating two different doses of our vaccine among healthy adults who had previously been vaccinated with MRNA vaccine. Those results, the readout we believe will be around the middle or thereabouts of June. That's what the statisticians telling us because they told us other dates previously, but they're crunching it out and we're getting there, so we hope to be making announcement within, before the end of next month.

    一項研究已經完成,即健康志願者研究,我們正在對先前接種過 MRNA 疫苗的健康成年人進行兩種不同劑量疫苗的評估。我們相信這些結果將在六月中旬左右公佈。這是統計人員告訴我們的,因為他們之前告訴我們其他日期,但他們正在計算,我們很快就能確定,所以我們希望在下個月底之前宣布這一消息。

  • So that would be there. We have the CLL trial which we announced, very promising encouraging results in November. That was the randomized comparison of our vaccine to the Pfizer vaccine among CLL patients. You may recall that the at the interim review, the Pfizer arm did not meet its end point and it was subsequently halted on the recommendation of the data safety monitoring board.

    所以它就在那裡。我們宣布了 CLL 試驗,並在 11 月取得了非常令人鼓舞的結果。這是我們的疫苗與輝瑞疫苗在 CLL 患者中進行的隨機比較。您可能還記得,在中期審查中,輝瑞團隊沒有達到終點,隨後根據資料安全監測委員會的建議停止了研究。

  • The study continues. It's an investigator initiated study. It continues towards completion. I think there remains about approximately 24 more patients to complete that trial we're hoping they will be completed yet this year again we don't, it's not our sponsored study, so we have less control and influence over it, but we work as close as we can with the investigator that's one that we believe demonstrates very nicely and encouragingly that our vaccine is apparent is apparently doing something which we would like to see that it's doing providing value to patients with compromised immune systems where we're not seeing that being validated in in various studies but certainly in this in this study.

    研究仍在繼續。這是一項由研究人員發起的研究。它將繼續完成。我認為還有大約 24 名患者需要完成該試驗,我們希望他們能夠完成,但今年我們還是沒有完成,這不是我們贊助的研究,因此我們對其的控制和影響較小,但我們會盡可能與研究人員密切合作,我們相信這非常好且令人鼓舞地證明了我們的疫苗顯然正在發揮我們希望看到的功效,即為免疫系統受損的患者提供價值,我們尚未在各種研究中看到這一點。

  • And then we have the immune the hematologic cancer patients who are being prepped for stem cell transplant or therapy and that study contends to enroll patients in the preliminary data that have been coming out including what was presented last week at the World Vaccine Congress but continue to be very encouraging on that. That's also a randomized comparison that this case between our between our vaccine and the MRNA vaccine. So the patients in the other in the non GX arm are either receiving Pfizer or Moderna,

    然後,我們有免疫系統的血液癌症患者正在準備接受幹細胞移植或治療,這項研究爭取讓患者參與已經公佈的初步數據,包括上週在世界疫苗大會上公佈的數據,但在這方面仍然非常令人鼓舞。這也是我們的疫苗與 MRNA 疫苗之間的隨機比較。因此,非 GX 組的患者要麼接受輝瑞治療,要麼接受 Moderna 治療,

  • So, we're looking and monitoring the statements, and certainly we saw the recent statement that the Secretary of HHS came out, indicating his preference for multi-antigen vaccines, versus single antigen vaccines related to use within certain infectious disease categories. We obviously believe very strongly that there is a enhance value by a multi-antigen vaccine.

    因此,我們正在關注和監測這些聲明,當然,我們看到了衛生和公共服務部部長最近發表的聲明,表明他傾向於使用多抗原疫苗,而不是在某些傳染病類別中使用的單一抗原疫苗。我們顯然堅信多重抗原疫苗具有增強價值。

  • I also point out that we do have an active bar of proposal for moving forward with our advanced MVA based manufacturing process that was deemed worthy. We received notes that was deemed worthy of funding by BARDA, but right now they've made no awards because of funding levels and considerations they're all that are going on, but they have indicated in some instances proposals that were not acceptable. Ours has been placed into a two year basket for funding as the money becomes available and we're quite encouraged and excited about that also. So we remain with our MVA vaccine CM04S1as well as our overall MVA, advanced MVA manufacturing process and our dealings with the government. We remain optimistic and very positive in that regard.

    我還指出,我們確實有一個積極的提案標準,以推進我們被認為是有價值的基於先進 MVA 的製造流程。我們收到了 BARDA 認為值得資助的通知,但目前他們還沒有授予任何獎項,因為資金水平和考慮因素都是他們正在做的事情,但他們在某些情況下指出了不可接受的提案。我們的資金已放入為期兩年的資助籃子中,一旦資金到位,我們對此感到非常鼓舞和興奮。因此,我們將繼續保留 MVA 疫苗 CM04S1 以及我們的整體 MVA、先進的 MVA 製造流程和與政府的往來。對此,我們依然保持樂觀和積極的態度。

  • James Molloy - Analyst

    James Molloy - Analyst

  • Well, I thank you, David. Certainly a lot of moving parts. I appreciate your input.

    好吧,謝謝你,大衛。確實有很多活動部件。我很感謝您的意見。

  • David Dodd - Chairman of the Board, President, Chief Executive Officer

    David Dodd - Chairman of the Board, President, Chief Executive Officer

  • Thank you.

    謝謝。

  • Operator

    Operator

  • Thank you. (Operator Instructions)

    謝謝。(操作員指示)

  • Our next question comes from Robert LeBoyer with Noble Capital Markets. Your line is open.

    我們的下一個問題來自 Noble Capital Markets 的 Robert LeBoyer。您的線路已開通。

  • Robert LeBoyer - Analyst

    Robert LeBoyer - Analyst

  • Good afternoon. And based on the upcoming results in the healthy volunteers trial, what are you thinking in terms of the next steps for a trial in terms of size? funding? and just length of trial any any thoughts or guidance that you can share with us?

    午安.根據健康志願者試驗即將得出的結果,您認為下一步試驗的規模應該如何?資金?以及試用期長度,您有什麼想法或指導可以與我們分享嗎?

  • David Dodd - Chairman of the Board, President, Chief Executive Officer

    David Dodd - Chairman of the Board, President, Chief Executive Officer

  • Sure, our focus is not primarily on otherwise healthy individuals. It's always been focused on the immunocompromised populations for the simple reason that these are individuals who do not respond to antibody stimulation, which is the basis or the target for the single antigen vaccines, those that are authorized as well as others in development. And we believe that this provides us, in the case of the United States, only 40 million plus population that currently remain in a pandemic state because they don't respond to the current vaccines, either the MRNAs or the protein adjuvant from Novava so we continue to feel very strongly that this is an ideal point of differentiation for fulfilling an unmet medical need and making a real difference.

    當然,我們的關注點主要不是健康個體。它始終專注於免疫功能低下的人群,原因很簡單,這些人對抗體刺激沒有反應,這是單一抗原疫苗(已授權的疫苗以及正在開發的其​​他疫苗)的基礎或目標。我們相信,就美國而言,這只為目前仍處於大流行狀態的 4000 多萬人口提供了幫助,因為他們對目前的疫苗(無論是 MRNA 還是 Novava 的蛋白質佐劑)都沒有反應,因此我們仍然強烈地認為,這是一個理想的差異點,可以滿足尚未滿足的醫療需求並帶來真正的改變。

  • So our goal has never been to go further with towards registration in a healthy volunteer population when it require a much larger type of clinical trial as you're hearing in discussions with the current vaccines, no vaccines as a prime example of going after that population. So it's looking for taking market share away from Pfizer and Moderna. We've always looked at it as we would be creating a new submarket because it's currently not being addressed, so we would have the opportunity for a leadership position in there. We believe that by this trial it would give us some some good indication of data that would be reflective of how our vaccine operates within an otherwise healthy population that was also our focus for Project NextGen.

    因此,我們的目標從來都不是進一步在健康志願者群體中進行登記,因為這需要進行更大規模的臨床試驗,正如您在討論當前疫苗時所聽到的,沒有疫苗就是針對該群體的典型例子。因此,它希望從輝瑞和 Moderna 手中奪取市場份額。我們一直將其視為創建一個新的子市場,因為該市場目前尚未解決,因此我們有機會在該市場佔據領導地位。我們相信,透過這次試驗,它將為我們提供一些很好的數據指示,這些數據將反映我們的疫苗在健康人群中的效果,這也是我們 NextGen 計畫的重點。

  • We were not looking to go forward after doing 10,000 patients, 5,000 each and doing a much larger study in otherwise healthy volunteers. It would have generated for us a very strong database of how our vaccine works in otherwise healthy individuals which would then be the basis for comparison of how our vaccine works in otherwise healthy patients versus immunocompromised populations, be it CLL patients, be it people with renal disease, whatever the target audience was.

    在對 10,000 名患者(每人 5,000 名)進行研究,並對其他方面健康的志願者進行更大規模的研究後,我們並不打算繼續進行下去。它將為我們產生一個非常強大的資料庫,用於了解我們的疫苗在其他健康個體中如何發揮作用,然後以此為基礎比較我們的疫苗在其他健康患者和免疫功能低下人群中如何發揮作用,無論是慢性淋巴細胞白血病患者,還是腎病患者,無論目標受眾是誰。

  • So that's how we're looking for our focus going forward is going to be couple fold one is going to be look at the results that come out of the current investigator initiated trial for CLL patients, if the results of that, trial are continue to be encouraging, then we'll look at doing an expanded trial that'll be a company sponsored trial that would feed into a dossier that would be developed for registration, we would also utilize that as a as a initial entry point of discussion for expedited review with regulatory authorities because there is nothing else for these patients from a vaccine standpoint. So that's our general approach of developing CMO4S1 is around the immunocompromise looking and fulfilling the opportunities where patients otherwise do not have a vaccine to help prevent.

    因此,我們未來的重點將是幾個方面​​,首先是查看當前研究者針對 CLL 患者發起的試驗的結果,如果該試驗的結果繼續令人鼓舞,那麼我們將考慮進行一項擴展試驗,這將是一項由公司贊助的試驗,它將納入為註冊而開發的檔案,我們還將以此作為與監管機構進行快速審查的初步討論點切入,因為從疫苗的角度來看,這些患者沒有其他選擇。因此,我們開發 CMO4S1 的整體方法是圍繞免疫缺陷尋找並實現機會,否則患者沒有疫苗可以幫助預防。

  • And remember that our vaccine has shown much more robustness in terms of protection against variants. If you recall, we've demonstrated protective immunity from the original Wuhan strain through the Omicron XVB 1.5 without having to reconfigure.

    請記住,我們的疫苗在預防變異方面表現出了更強的穩健性。如果您還記得的話,我們已經透過 Omicron XVB 1.5 證明了對原始武漢病毒株的保護性免疫,而無需重新配置。

  • Now that in and of itself is a major deficiency, and that's part of the problem that Novavax is dealing with is they're being asked to do a full clinical trial to show that. That an updated construct is worthy of signing off by the FDA, and what the FDA and not the FDA ,what HHS is really looking for as they iterated in in the announcement about the universal one is something that works across multiple generations of variants and so far the only vaccine we've seen that has consistently shown that has been GEO-CM04S1.

    這本身就是一個重大缺陷,也是 Novavax 所面臨的問題的一部分,他們被要求進行全面的臨床試驗來證明這一點。更新後的疫苗結構值得 FDA 簽署,FDA 而不是 FDA,HHS 真正尋求的,正如他們在關於通用疫苗的公告中反复提到的那樣,是一種可以跨多代變體起作用的疫苗,到目前為止,我們所見過的唯一一種始終如一地證明這一點的疫苗是 GEO-CM04S1。

  • So that's where our focus is and where we think we have a major difference by taking the approach we have of a multi-antigen approach targeting and applying it to populations for whom current existing vaccines, they all happen to be single antigen or simply inadequate.

    因此,這就是我們的重點所在,我們認為我們有一個重大差異,即採用多抗原方法,將其應用於目前現有疫苗都只有單一抗原或根本不適用的人群。

  • Robert LeBoyer - Analyst

    Robert LeBoyer - Analyst

  • Okay, thank you very much.

    好的,非常感謝。

  • Mark Reynolds - Chief Financial Officer, Corporate Secretary

    Mark Reynolds - Chief Financial Officer, Corporate Secretary

  • Thank you. Appreciate your interest.

    謝謝。感謝您的關注。

  • Operator

    Operator

  • Thank you. Our next question comes from Jeffrey Kraws with Crystal Research Associates. Your line is open.

    謝謝。我們的下一個問題來自 Crystal Research Associates 的 Jeffrey Kraws。您的線路已開通。

  • Jeffrey Kraws - Analyst

    Jeffrey Kraws - Analyst

  • Thank you very much, David, several of my questions were answered, but two remaining questions. You haven't seen anything contrary to your balance safety and efficacy with your Mpox vaccine, that is, you haven't seen any of the challenges and the complications that people are seeing with the myocarditis, encephalitis or other complications, correct?

    非常感謝,大衛,我的幾個問題都得到了回答,但還有兩個問題。您沒有看到任何與 Mpox 疫苗的平衡安全性和有效性相悖的情況,也就是說,您沒有看到人們在心肌炎、腦炎或其他併發症中看到的任何挑戰和併發症,對嗎?

  • David Dodd - Chairman of the Board, President, Chief Executive Officer

    David Dodd - Chairman of the Board, President, Chief Executive Officer

  • No, not at all, and MVA was developed in the late 60s, early 70s specifically to be utilized among people who have compromised immune systems, pregnant women and children. The fact that it does not replicate in humans or mammals, but so it's humans means that it's and it's been recognized for being exquisitely safe and that's one thing you can count on with MVA. It's always been shown to be extremely safe.

    完全不是,MVA 是在 20 世紀 60 年代末、70 年代初開發的,專門用於免疫系統受損的人群、孕婦和兒童。事實上,它無法在人類或哺乳動物體內複製,但對人類來說卻如此,這意味著它被公認為極其安全,這是 MVA 值得信賴的一點。事實證明它非常安全。

  • We've mentioned in the past that you know we received an exemption from MVA to not have to do the animal toxicology studies because with MVA it's recognized for its safety by regulatory authorities worldwide. So one thing that most people recognize with MVA has always been its safety. It was specifically developed for patients for whom the traditional vaccinia was contraindicated.

    我們過去曾提到,您知道我們獲得了 MVA 的豁免,無需進行動物毒理學研究,因為 MVA 的安全性已得到世界各地監管機構的認可。因此,大多數人對 MVA 的認可始終是它的安全性。它是專門為不適合接種傳統牛痘的患者所開發的。

  • We would not have been able, the world would not have been able to rid itself of smallpox otherwise. So we feel very strongly about that. But the challenge with MVA and in the hurdle has always been the complicated cumbersome manufacturing process because it's very slow, it's very cumbersome and that's why typically products are stockpiled but that's why we went forward 4.5 plus years ago towards this advanced MVA manufacturing process which now we have in process development so but we have not seen those types of side effects in in any of our MVA based products.

    否則我們就無法消滅天花,世界也無法消滅天花。所以我們對此感受非常強烈。但是 MVA 所面臨的挑戰和障礙一直是複雜繁瑣的製造工藝,因為它非常緩慢、非常麻煩,這就是為什麼通常產品會被囤積的原因,但這也是我們在 4.5 年多前就朝著這種先進的 MVA 製造工藝邁進的原因,現在我們已經進入了工藝開發階段,但我們在任何基於 MVA 的產品中都沒有看到這些副作用。

  • Jeffrey Kraws - Analyst

    Jeffrey Kraws - Analyst

  • Great, and that is helpful because the rumor mill out there, of course, runs wild with both those issues. So thank you for confirming what our beliefs were.

    很好,這很有幫助,因為外面關於這兩個問題的謠言四起。所以感謝您確認了我們的信念。

  • The second question relates around the backbone of vaccine manufacturing. You indicated in the call here that obviously there's a move underway to sort of move from having, vaccines and all the constructs of vaccines, manufactured outside this country as many of the basis are in China right now.

    第二個問題涉及疫苗製造的支柱。您在電話中表示,顯然我們正在採取行動,不再在國外生產疫苗和所有疫苗結構,因為目前許多疫苗基礎都在中國。

  • Are you receiving support or indications of support in your conversations with the government for having a, US-based manufacturing piece? I would think that would be something that, they're involved in. I know you brought up BARDA and you said funding is all halted right now on that construct, but would you expect significant movement there given your proclivity for manufacturing here.

    在與政府的對話中,您是否獲得了對在美國設立製造部門的支持或支持跡象?我認為那是他們參與的事情。我知道您提到了生物醫學高級研究與發展局 (BARDA),並且您說目前對該項目的資金已經全部停止,但考慮到您在這裡進行製造業的傾向,您是否預計該項目會有重大進展?

  • David Dodd - Chairman of the Board, President, Chief Executive Officer

    David Dodd - Chairman of the Board, President, Chief Executive Officer

  • Well, everybody right now there's not an MVA manufacturer or contract CDMO manufacturer in the United States. So if you're doing MVA, you have to go and that's why we're working with Oxford Biomedical and the manufacturing for us right now is being done outside the US and France specifically.

    嗯,各位,目前美國沒有 MVA 製造商或合約 CDMO 製造商。因此,如果您正在進行 MVA,您就必須去,這就是我們與牛津生物醫學公司合作的原因,我們目前的製造業務是在美國和法國以外進行的。

  • However, helping this new method and all in our relationship with Oxford Biomedical, we would anticipate as we go forward with the advanced MVA manufacturing that that will be manufactured in the United States and we do, as I mentioned, we submitted a proposal a little over a year ago when that RFP came out from Florida.

    然而,透過這種新方法以及我們與牛津生物醫學公司的關係,我們預計隨著先進 MVA 製造的推進,這些製造將在美國進行,正如我所提到的,我們在一年多前從佛羅裡達州發出 RFP 時提交了一份提案。

  • They made no awards on it, but we recently were informed that our proposal was deemed appropriate for funding, passed the mustard there and it's been placed in a two year what they call it basket so that as funding may occur and come forward and course that'll be competing with whatever alternative options people are looking at this and that to to utilize the funding from the government, we discussed this with legislators. Well, with congressmen, with the representatives, our senators, we discussed it with with other representatives on that would have an interest in that.

    他們沒有授予任何獎項,但我們最近獲悉,我們的提案被認為適合獲得資助,通過了審核,並被放入為期兩年的所謂“籃子”中,以便資金能夠到位並推進,當然,這將與人們正在考慮的其他選擇競爭,以便利用政府的資金,我們與立法者討論了這個問題。好吧,我們和國會議員、眾議員、參議員以及其他對此感興趣的代表討論了這個問題。

  • So we believe that what we will migrate towards will be US based manufacturing of our MVA based vaccines. I've been asked by a couple of, Let's say stakeholders, what would it take to go even faster? And the answer is very simple. It's your balance sheet drives that, and I usually point out to them that I'm having to sit across, having to be sitting across from a person that could make a difference there. So those discussions so far no one has handed me a check, but so far handed us a check, I should say, but so far those discussions continue.

    因此,我們相信,我們將轉向在美國生產基於 MVA 的疫苗。有幾個利害關係人問我,怎樣才能加快速度?答案很簡單。這是你的資產負債表驅動的,我通常會向他們指出,我必須坐在對面,必須坐在一個可以帶來改變的人對面。因此,到目前為止,還沒有人給我支票,但是到目前為止,我應該說已經給我們支票了,但到目前為止,這些討論仍在繼續。

  • A week after next I'll be briefing people in Washington DC, legislator, their staffs, etc. And decision makers, influencers, and all of that. So I'll be doing that both as part of a group and as well as individually. So we continue to go forward with that because our commitment is to establish US based manufacturing, even if it's using a CDMO and that's what we're working towards with our relationship with Oxford Biomedical

    下下週我將向華盛頓特區的人們、立法者、他們的工作人員等以及決策者、有影響力的人等簡報。因此,我將以團隊和個人的身份來做這件事。因此,我們將繼續推進這一進程,因為我們的承諾是建立美國製造,即使使用 CDMO,這也是我們與牛津生物醫學公司合作的目標。

  • Robert LeBoyer - Analyst

    Robert LeBoyer - Analyst

  • Perfect. Thank you very much, David.

    完美的。非常感謝,大衛。

  • David Dodd - Chairman of the Board, President, Chief Executive Officer

    David Dodd - Chairman of the Board, President, Chief Executive Officer

  • You're welcome. Thank you.

    不客氣。謝謝。

  • Operator

    Operator

  • 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 David Dodd 並請他做最後發言。

  • David Dodd - Chairman of the Board, President, Chief Executive Officer

    David Dodd - Chairman of the Board, President, Chief Executive Officer

  • Alright, thank you, everyone. I really appreciate your interest.

    好的,謝謝大家。我非常感謝您的關注。

  • Let me just say that.

    我只想說這一點。

  • As always, I'd like to acknowledge the ongoing support and thank our board of directors and our advisers, and especially our staff and the many others, either consultants, contractors, but the many other parties who continue to support us towards achieving the success we believe that we have underway here.

    像往常一樣,我要感謝大家的持續支持,並感謝我們的董事會和顧問,特別是我們的員工和許多其他人,無論是顧問、承包商,還是許多其他方,他們繼續支持我們實現我們相信我們已經取得的成功。

  • We indeed remain committed to providing meaningful career development opportunities for what we consider highly competitive, quality oriented individuals who want to be part of the disruption of the current paradigm of cancer therapies and infectious disease vaccines, and we're most proud and appreciative of our team, including those external partners because they're dedicated to us, they're supportive of us, and they're part of our ongoing success.

    我們確實一直致力於為那些我們認為具有高度競爭力、注重品質、希望成為顛覆當前癌症治療和傳染病疫苗模式的一部分的個人提供有意義的職業發展機會,我們為我們的團隊感到最自豪和感激,包括那些外部合作夥伴,因為他們對我們忠誠,他們支持我們,他們是我們持續成功的一部分。

  • So for those of you who have taken the time to participate in this, we especially want to thank you because you're not only interested, sometimes you may have been assigned to listen to this broadcast, but we know that you are sincere you give us good counsel, good guidance, and we appreciate that.

    因此,對於那些花時間參與此事的人,我們特別要感謝你們,因為你們不僅感興趣,有時你們可能被指派收聽這次廣播,但我們知道你們是真誠的,你們給了我們很好的建議和指導,我們對此表示感謝。

  • Just lastly I would just underscore that our overriding goal is to drive products through to the registration point to improve lives worldwide through these efforts and especially in these two areas. So with that I look forward to keeping you updated hopefully in between the next call but also at the next call. So thank you and have a wonderful day.

    最後,我想強調的是,我們的首要目標是推動產品進入註冊階段,透過這些努力,特別是在這兩個領域的努力,改善全世界人民的生活。因此,我希望能夠在下次通話期間以及下次通話時向您通報最新情況。謝謝你,祝你有美好的一天。

  • Operator

    Operator

  • The conference is now concluded.

    會議現已結束。

  • Thank you for attending today's presentation. You may now disconnect.

    感謝您參加今天的演講。您現在可以斷開連線。