GeoVax Labs Inc (GOVX) 2023 Q1 法說會逐字稿

完整原文

使用警語:中文譯文來源為 Google 翻譯,僅供參考,實際內容請以英文原文為主

  • Operator

    Operator

  • Good afternoon, and welcome, everyone to the GeoVax first quarter 2023 corporate update call. My name is Jack, and I will facilitate today's call. With me are David Dodd, Chairman and 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 2023 年第一季度公司更新電話會議。我叫傑克,今天的電話會議由我主持。和我一起的是董事長兼首席執行官 David Dodd;馬克·雷諾茲,首席財務官; Mark Newman 博士,首席科學官; Kelly McKee,醫學博士,公共衛生碩士,首席醫療官;和業務發展副總裁 John Sharkey 博士。

  • (Operator Instructions) As a reminder, this conference is being recorded. At this time, I'll turn the call over to Gabby DeGravina of GC Capital.

    (操作員說明)提醒一下,正在錄製此會議。這時,我會將電話轉給 GC Capital 的 Gabby DeGravina。

  • Gabby DeGravina - IR

    Gabby DeGravina - IR

  • 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。請注意以下事項。本演示文稿中的某些陳述可能構成《私人證券訴訟改革法》含義內的前瞻性陳述。這些陳述基於管理層當前的預期,並受不確定性和環境變化的影響。

  • Actual results may differ materially from those included in these statements due to a variety of factors, including whether: GeoVax can develop and manufacture it's product candidates with the 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, there is development of competitive products that may be more effective or easier to use that GeoVax's products; GeoVax will be able to enter into favorable manufacturing and distribution agreements; and other factors over which GeoVax has no control.

    由於各種因素,實際結果可能與這些陳述中包含的結果存在重大差異,包括: GeoVax 的疫苗將有效預防人類的靶向感染; GeoVax 的候選產品將獲得獲得許可和上市所需的監管批准; GeoVax 籌集到完成其產品開發所需的資金,正在開發比 GeoVax 的產品更有效或更易於使用的競爭產品; GeoVax 將能夠簽訂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 as risk factors in GeoVax's Form 10-K.

    GeoVax 不承擔更新這些前瞻性陳述的義務,也不打算這樣做。有關這些因素的更多信息包含在 GeoVax 提交給美國證券交易委員會的文件中,包括 GeoVax 10-K 表格中列為風險因素的那些。

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

    現在我很高興介紹 GeoVax 的董事長兼首席執行官。大衛多德。大衛?

  • David Dodd - Chairman, President & CEO

    David Dodd - Chairman, President & CEO

  • Good afternoon, and thank you for participating in the GeoVax corporate update call. Since the start of 2023, we have expanded patient enrollment and supported the Gedeptin Phase 2 clinical trial, and the two Phase 2 trials for GEO-CM04S1; also, the third Phase 2 clinical program in support of CM04S1, evaluating the vaccine as a booster among patients with chronic lymphocytic leukemia has viewed by the FDA and is expected to initiate soon.

    下午好,感謝您參與 GeoVax 公司更新電話會議。自 2023 年初以來,我們擴大了患者入組並支持了 Gedeptin 2 期臨床試驗,以及 GEO-CM04S1 的兩項 2 期試驗;此外,支持 CM04S1 的第三個 2 期臨床計劃評估了該疫苗作為慢性淋巴細胞白血病患者的助推器,該計劃已獲得 FDA 的審查,預計將很快啟動。

  • We also recently expanded our rights related to CM04S1 to include all omicron variants, monkeypox, and smallpox, further differentiating our COVID-19 vaccine. While the clinical development progress Gedeptin and the CM04S1 remain our priority, we are also focused on GEO-MVA, our vaccine against monkeypox and smallpox; as well as the implementation of the transformative MVA continuous cell line manufacturing process.

    我們最近還擴大了與 CM04S1 相關的權利,以包括所有 omicron 變體、猴痘和天花,進一步區分我們的 COVID-19 疫苗。雖然 Gedeptin 和 CM04S1 的臨床開發進展仍然是我們的優先事項,但我們也專注於 GEO-MVA,我們的猴痘和天花疫苗;以及變革性 MVA 連續細胞系製造工藝的實施。

  • Last year, we strengthened our balance sheet adding $37 million during a very difficult investment environment especially for the biotech industry. This enabled us to expand our current clinical programs, including additional sites, while also adding near-term opportunities related to further development opportunities, including our MVA manufacturing process, and expanding our oncology programs. We expect that our cash position will support our increased clinical program expansions and other initiatives through the remainder of this year.

    去年,我們加強了資產負債表,在非常困難的投資環境中增加了 3700 萬美元,尤其是對生物技術行業而言。這使我們能夠擴展我們當前的臨床項目,包括更多的站點,同時還增加了與進一步發展機會相關的近期機會,包括我們的 MVA 製造工藝,並擴展了我們的腫瘤學項目。我們預計我們的現金狀況將在今年剩餘時間內支持我們增加的臨床項目擴展和其他舉措。

  • In the [interim] we will evaluate opportunities to further strengthen our balance sheet, resulting from supportive stock activities, business development opportunities, and non-dilutive opportunities related to government, and NGO funding. Gedeptin is a cancer therapy currently and has expanded multisite evaluation among patients suffering from advanced head and neck cancers. The product has received orphan drug designation and funding for the current clinical trial from the FDA orphan drug has clinical trials program.

    在此期間,我們將評估進一步加強資產負債表的機會,這些機會來自支持性股票活動、業務發展機會以及與政府和非政府組織資金相關的非稀釋性機會。 Gedeptin 是目前的一種癌症療法,已在患有晚期頭頸癌的患者中擴展了多點評估。該產品已獲得 FDA 孤兒藥臨床試驗計劃的孤兒藥指定和當前臨床試驗的資助。

  • Our target population for the initial indication includes head and neck cancer patients, who are receiving palliative care, having failed other therapies and medical interventions. There are approximately 67,000 new cases of head and neck cancers annually in the US, and approximately 13,000 deaths annually resulting from head-and-neck cancers. This represents our initial targeted patient population. Worldwide, there are approximately 900,000 new cases of head and neck cancers annually, and approximately 400,000 deaths.

    我們的初始適應症目標人群包括接受姑息治療、其他療法和醫療干預失敗的頭頸癌患者。美國每年大約有 67,000 例頭頸癌新發病例,每年大約有 13,000 例死於頭頸癌。這代表了我們最初的目標患者群體。在全球範圍內,每年大約有 900,000 例頭頸癌新發病例,約有 400,000 例死亡。

  • Patients suffering from advanced head and neck cancer represents a critical unmet medical need which we hope to address. The FDA funding the initial 10 patient portion of the clinical program underscores the recognition of this critical unmet medical need. Our focus is on completing the 10-patient study funded by the FDA. We anticipate completion of the initial 10 patient study yet this year including our review of the results. We will review those results with the FDA along with our recommendations for an expanded program, while also discussing with the FDA the potential for an expedited BLA filing.

    患有晚期頭頸癌的患者代表了我們希望解決的關鍵未滿足醫療需求。 FDA 為臨床計劃最初的 10 名患者部分提供資金,強調了對這一未滿足的關鍵醫療需求的認識。我們的重點是完成由 FDA 資助的 10 名患者的研究。我們預計今年將完成最初的 10 名患者研究,包括我們對結果的審查。我們將與 FDA 一起審查這些結果以及我們對擴展計劃的建議,同時還將與 FDA 討論加快 BLA 申請的可能性。

  • We're excited about the outlook and promise of Gedeptin within advanced head and neck cancers, as well as other opportunities related to the expanded use in other indications. We foresee significant opportunity in addressing various tumors as monotherapy, as well as potential combo therapy in conjunction with other therapies such as immune checkpoint inhibitors. We also anticipate potential synergy with the GeoVax [Mark-1] tumor-associated antigen approach. Relative to commercialization, we anticipate partnering and collaborations in support of worldwide use for which business development activities have already been initiated.

    我們對 Gedeptin 在晚期頭頸癌中的前景和前景以及與在其他適應症中擴大使用相關的其他機會感到興奮。我們預見到將各種腫瘤作為單一療法以及與免疫檢查點抑製劑等其他療法相結合的潛在組合療法的重要機會。我們還預計與 GeoVax [Mark-1] 腫瘤相關抗原方法的潛在協同作用。相對於商業化,我們期待合作和協作,以支持已經啟動業務開發活動的全球使用。

  • We hold worldwide rights for the use of Gedeptin and all indications. The vast array of unmet medical needs within oncology represents significant opportunities for GeoVax to advance novel approaches, addressing various cancer patient needs worldwide. Throughout 2023, we are participating in various oncology conferences, some of which we expect Gedeptin presentations and with others, Gedeptin partnering discussions.

    我們擁有使用 Gedeptin 和所有適應症的全球權利。腫瘤學中大量未滿足的醫療需求為 GeoVax 提供了推進新方法、滿足全球各種癌症患者需求的重要機會。在整個 2023 年,我們將參加各種腫瘤學會議,其中一些我們期待 Gedeptin 的演講,並與其他人一起進行 Gedeptin 合作討論。

  • GEO-CM04S1, our next-generation COVID-19 vaccine differentiates from the current authorized COVID-19 vaccines in targeting both the antibody and cellular arms of the immune system, focusing on providing a more robust and durable protection than the current authorized vaccines. This is critically important in addressing the high-risk populations of immune compromised individuals for whom the current authorized vaccines and monoclonal antibodies are inadequate.

    GEO-CM04S1 是我們的下一代 COVID-19 疫苗,它與當前授權的 COVID-19 疫苗的區別在於同時針對免疫系統的抗體和細胞臂,重點是提供比當前授權疫苗更強大和持久的保護。這對於解決當前授權疫苗和單克隆抗體不足的免疫受損個體的高風險人群至關重要。

  • Such populations include those with various blood cancers, renal disease, sickle cell anemia, HIV positive, autoimmune diseases such as lupus, and those on immune suppressive therapy. In general, patient groups with abated immune systems unable to respond adequately to approved mRNA vaccines are at such high risk.

    這些人群包括患有各种血癌、腎病、鐮狀細胞性貧血、HIV 陽性、狼瘡等自身免疫性疾病以及接受免疫抑制治療的人群。一般而言,免疫系統減弱且無法對批准的 mRNA 疫苗做出充分反應的患者群體處於如此高的風險中。

  • In the US, there are approximately 12 million to 15 million individuals within this overall population, with over 200 million worldwide. There is a major critical need for next-generation COVID-19 vaccines to support such individuals. And we believe the CM04S1 is the leading next-generation vaccine in clinical development. Our recently published article in the New England Journal of Medicine highlights the critical need for a vaccine to induce both antibodies and T-cells for optimal protection against SARS-CoV-2 infection. CM04S1 is specifically constructed to include the spike protein and the nucleocapsid protein, and to induce a broader focused immune response specific to those proteins on the SARS-CoV-2 virus.

    在美國,這一總人口中大約有 1200 萬至 1500 萬人,全世界有超過 2 億人。迫切需要下一代 COVID-19 疫苗來支持這些人。我們相信 CM04S1 是臨床開發中領先的下一代疫苗。我們最近在《新英格蘭醫學雜誌》上發表的文章強調了迫切需要一種疫苗來誘導抗體和 T 細胞,以針對 SARS-CoV-2 感染提供最佳保護。 CM04S1 專門構建為包括刺突蛋白和核衣殼蛋白,並誘導針對 SARS-CoV-2 病毒上這些蛋白質的更廣泛的集中免疫反應。

  • Clinical evaluation demonstrated the CM04S1 does, in fact, induce both strong antibody and T-cell responses against both the spike and nucleocapsid proteins. The results of this clinical study were reported last year in the Lancet Microbe publication of the Phase 1 data. The adoption of T-cell immune responses is especially critical among those patient populations, who have immune systems with depleted ability to mount effective antibody responses.

    臨床評估表明,CM04S1 實際上確實會誘導針對刺突蛋白和核衣殼蛋白的強烈抗體和 T 細胞反應。這項臨床研究的結果於去年在第一階段數據的柳葉刀微生物出版物中進行了報導。 T 細胞免疫反應的採用在那些免疫系統無法產生有效抗體反應的患者群體中尤為重要。

  • New safety and immune response data from the Phase 2 trial were presented at the World Vaccine Congress in Washington DC, during April of 2023, highlighting the potential effectiveness of this vaccine in patients undergoing different types of treatments for hematologic cancer. Clinical testing of this vaccine continues to provide compelling data supporting development and [alternate] use in the targeted patient populations. While the noise of COVID seems to have died down, SARS-CoV-2 continues to evolve with threatening variants of concern. It is well accepted that the current authorized vaccines are not sufficiently protective and that their durability is unsatisfactory.

    2023 年 4 月在華盛頓特區舉行的世界疫苗大會上公佈了 2 期試驗的新安全性和免疫反應數據,強調了該疫苗對接受不同類型血液癌症治療的患者的潛在有效性。該疫苗的臨床測試繼續提供令人信服的數據,支持在目標患者人群中的開發和[替代]使用。儘管 COVID 的喧囂似乎已經平息,但 SARS-CoV-2 仍在繼續演變,帶來令人擔憂的威脅變種。公認的是,當前授權的疫苗沒有足夠的保護作用,而且它們的持久性也不能令人滿意。

  • In fact, just a few weeks ago, the White House announced Project Next Gen, a $5 billion initiative, the follow-on from Operation Warp Speed seeking COVID-19 vaccines with enhanced breadth of protection against variants and improved durability, particularly being interested in novel vaccine candidates in clinical trial or capable of entering clinical trials within the next nine months.

    事實上,就在幾週前,白宮宣布了一項耗資 50 億美元的“下一代計劃”,這是“曲速行動”的後續行動,旨在尋求 COVID-19 疫苗,以增強對變體的保護範圍並提高耐用性,特別是對正在臨床試驗中或能夠在未來九個月內進入臨床試驗的新型候選疫苗。

  • We believe the CM04S1 is the leading example of the desired next-generation vaccines. We have considerable interest both domestically and internationally in participating in our clinical development program. We believe that an opportunity for an expedited regulatory path will likely exist due to our focus on high-risk populations unserved by the current COVID-19 vaccines as well as the monoclonal antibody therapy. Also, we anticipate partnering collaborations and support of worldwide commercialization and distribution.

    我們相信 CM04S1 是所需下一代疫苗的主要例子。我們在國內和國際上都對參與我們的臨床開發計劃非常感興趣。我們認為,由於我們關注當前 COVID-19 疫苗和單克隆抗體療法未提供服務的高危人群,因此可能存在加快監管路徑的機會。此外,我們期待合作夥伴的合作以及對全球商業化和分銷的支持。

  • Our focus for the remainder of 2023 includes accelerating efforts in support of Gedeptin in the CM04S1 Phase 2 clinical programs, advancing the GeoVax MVA vaccine specific for monkeypox and smallpox into development, and further advancement of our program focused on improved MVA manufacturing processes. Presentations are expected at various scientific and medical conferences to update the progress on both Gedeptin and CM04S1. We anticipate reporting further preclinical information related to the use of the Gedeptin technology used in conjunction with immune checkpoint inhibitors yet this year.

    我們在 2023 年剩餘時間內的重點包括在 CM04S1 2 期臨床項目中加快支持 Gedeptin 的工作,推進針對猴痘和天花的 GeoVax MVA 疫苗的開發,以及進一步推進我們專注於改進 MVA 製造工藝的項目。預計將在各種科學和醫學會議上發表演講,以更新 Gedeptin 和 CM04S1 的進展。我們預計今年還會報告與使用 Gedeptin 技術與免疫檢查點抑製劑結合使用相關的更多臨床前信息。

  • Regarding GEO-MVA, it is a vaccine against monkeypox and smallpox. Our intent is to be the first and primary US based supplier of an MVA based vaccine to protect against Mpox or monkeypox, or smallpox, providing expanded supply and access worldwide, especially related to low and middle-income countries which have consistently experienced significant difficulty in the supply of many critical vaccines. We are advancing this initiative and look forward to reporting progress quarterly.

    關於GEO-MVA,它是針對猴痘和天花的疫苗。我們的目標是成為美國第一個也是主要的基於 MVA 的疫苗供應商,以預防 Mpox 或猴痘或天花,在全球範圍內提供更多的供應和使用,特別是與低收入和中等收入國家相關,這些國家在疫苗接種方面一直遇到重大困難許多關鍵疫苗的供應。我們正在推進這一舉措,並期待每季度報告進展情況。

  • Last year of 2022, we strengthened our balance sheet, adding $37 million during a time of which many biotech firms were furloughing programs and or people. We feel that our capital development success has reflected investor support and belief in the value growth opportunities underway at GeoVax. We continue to receive strong interest related investment capital, which we will evaluate, but we're focused on execution towards our 2023 goals, strengthening shareholder value and achieving critical reporting milestones for our development programs.

    2022 年的最後一年,我們加強了資產負債表,增加了 3700 萬美元,在此期間許多生物技術公司都在休假計劃和/或人員。我們認為,我們資本開發的成功反映了投資者對 GeoVax 正在進行的價值增長機會的支持和信念。我們將繼續收到與利息相關的大量投資資本,我們將對其進行評估,但我們專注於執行我們的 2023 年目標,加強股東價值並實現我們發展計劃的關鍵報告里程碑。

  • 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,我想將演示文稿轉交給 GeoVax 首席財務官 Mark Reynolds,以審查我們最近的業績和財務狀況。標記?

  • Mark Reynolds - CFO

    Mark Reynolds - CFO

  • Thank you, David. I'll begin with a brief overview of our income statement. And I'll first point out that we reported no grant revenues during 2023 as compared to a small amount in 2022, which is reflective of the wind down of our grant from the US Army for our last fever preclinical program. I'll note, however, that we are actively seeking additional non-dilutive government funding for our preclinical and clinical development programs, and we expect this to be an important component of our financing mix in the future.

    謝謝你,大衛。我將從簡要概述我們的損益表開始。我首先要指出的是,與 2022 年的少量收入相比,我們報告了 2023 年沒有撥款收入,這反映了美國陸軍對我們上一個發熱臨床前項目的撥款逐漸減少。然而,我會注意到,我們正在積極為我們的臨床前和臨床開發項目尋求額外的非稀釋性政府資金,我們預計這將成為我們未來融資組合的重要組成部分。

  • Research and development expenses were $2.8 million in the first quarter of 2023 versus $1.3 million in 2022. The increase was planned and expected and is associated with clinical trial activity for our CM04S1 and Gedeptin programs. The increase is also reflective of higher personnel and consulting costs as we staffed up during 2022.

    2023 年第一季度的研發費用為 280 萬美元,而 2022 年為 130 萬美元。增加是計劃和預期的,並且與我們的 CM04S1 和 Gedeptin 項目的臨床試驗活動有關。這一增長還反映了我們在 2022 年增加人員時人員和諮詢成本的增加。

  • G&A expenses were $1.5 million in the first quarter of '23 as compared to $1.2 million in '22, with the increases also associated with higher personnel and consulting costs as well as patent costs. So overall, net loss for the first quarter of 2023 was $4 million or $0.15 per share, versus $2.4 million in 2022 or $0.34 per share. Again, with the increases primarily associated with the ramp-up of organizational infrastructure and other costs associated with the CM04S1 and Gedeptin clinical trials.

    G&A 費用在 23 年第一季度為 150 萬美元,而 22 年第一季度為 120 萬美元,增加還與更高的人員和諮詢成本以及專利成本有關。因此,總體而言,2023 年第一季度的淨虧損為 400 萬美元或每股 0.15 美元,而 2022 年為 240 萬美元或每股 0.34 美元。同樣,增加主要與組織基礎設施的增加以及與 CM04S1 和 Gedeptin 臨床試驗相關的其他成本有關。

  • Turning now to the balance sheet. Our cash balances at March 31 were $23.9 million, as compared to $27.6 million at December 31. The change in cash is reflective of $3.8 million used in operating activities. There were no significant financing or investing activities during the first quarter. Our outstanding common shares now stand at 26.4 million.

    現在轉向資產負債表。我們在 3 月 31 日的現金餘額為 2390 萬美元,而 12 月 31 日為 2760 萬美元。現金的變化反映了經營活動中使用的 380 萬美元。一季度無重大融資或投資活動。我們流通在外的普通股現在為 2640 萬股。

  • Funding our three ongoing Phase 2 clinical programs is obviously the most important use of our cash and our top financial priority. Our cash runway is sufficient to fund these programs through the milestones expected to occur over the course of this year, as David previously mentioned. We believe the advancement of our clinical programs will create an attractive investment opportunity for new fundraising activities, and I'll be happy to answer any questions during the Q&A period. So I'll now turn the call back over to David.

    資助我們正在進行的三個二期臨床項目顯然是我們現金最重要的用途,也是我們的首要財務優先事項。正如 David 先前提到的,我們的現金跑道足以通過預計在今年發生的里程碑為這些計劃提供資金。我們相信我們臨床項目的進步將為新的籌款活動創造一個有吸引力的投資機會,我很樂意在問答期間回答任何問題。所以我現在將電話轉回給大衛。

  • David Dodd - Chairman, President & CEO

    David Dodd - Chairman, President & CEO

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

    謝謝你,馬克。我和我的同事現在將回答您的問題。與我們一起參加問答環節的有 Mark Newman 博士、Kelly McKee 博士和 John Sharkey,他們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 back to the operator for instructions on the question-and-answer period.

    我現在將電話轉回給接線員,以獲取有關問答期的說明。

  • Operator

    Operator

  • (Operator Instructions) Jason Kolbert, Dawson James.

    (操作員說明)Jason Kolbert,Dawson James。

  • Jason Kolbert - Analyst

    Jason Kolbert - Analyst

  • I'm here, thank you. Great job conserving capital resources and focusing on what's important clinical expenses, something that we couldn't say about this company a couple of years ago. One really interesting question I have is what kind of discussions are you having with the government about what they are looking for in terms of a next-generation COVID vaccine? They're probably thinking something ubiquitous for the population, but have you caught their attention, and have you had any of those discussions with them yet?

    我來了,謝謝。保存資本資源和專注於重要的臨床費用方面做得很好,這是幾年前我們無法對這家公司說的。我有一個非常有趣的問題是,您與政府就他們在尋找下一代 COVID 疫苗方面的需求進行了什麼樣的討論?他們可能在想一些對大眾來說無處不在的東西,但是你有沒有引起他們的注意,你有沒有和他們討論過這些?

  • David Dodd - Chairman, President & CEO

    David Dodd - Chairman, President & CEO

  • Sure, Jason. This is David, and thanks for your question. The April 10, the federal government issued the RFI request for information related to Project Next Gen, and that specifically outlined what they were looking for relative to criteria. And it was what I actually stated during my comments, about durability, a breadth of protection, and specifically focused on products that were already in the clinic or could enter the clinic within nine months.

    當然,傑森。我是大衛,謝謝你的提問。 4 月 10 日,聯邦政府發布了 RFI 請求,要求提供與下一代項目相關的信息,並具體概述了他們正在尋找的與標準相關的內容。這就是我在評論中所說的關於耐用性、保護範圍的內容,並特別關注已經進入臨床或可能在九個月內進入臨床的產品。

  • So, they're looking and recognizing that durability as a key issue, that the breadth of protection is an issue, and they are also -- there are populations out there for whom current vaccines and therapies are inadequate. So, they laid that out, that the process for the RFI is that you completed and submitted, which we did very quickly, very well-prepared, I'd say, response to it. They will go through those and then decide with whom they're going to follow-up for further information. At this stage, there was no discussion or providing information in terms of -- or how much money are you seeking for what purposes, we have that all outlines.

    因此,他們正在尋找並認識到持久性是一個關鍵問題,保護的廣度是一個問題,而且他們也是——目前的疫苗和療法對某些人群來說是不充分的。因此,他們規定,RFI 的流程是您完成並提交,我們做得非常快,準備充分,我會說,回應它。他們將檢查這些,然後決定他們將與誰一起跟進以獲取更多信息。在這個階段,沒有討論或提供信息——或者你為了什麼目的尋求多少錢,我們有所有的輪廓。

  • Now to address the question, we have had ongoing discussions with individuals within the federal government that includes those who are specifically part of the review team, et cetera, on Project Next Gen. We've been having such discussions for some time now, and had some even more recently on that, and have discussed with them, shared with them that we have accomplished thus far and what we're proceeding towards with the continuous cell-line manufacturing process, which seem to really capture some interest. Ultimately, we'll have to see how they respond.

    現在要解決這個問題,我們已經與聯邦政府內部的個人進行了持續的討論,其中包括審查團隊的具體成員,等等,關於下一代項目。我們已經進行了一段時間這樣的討論,並且最近有一些人對此進行了討論,並與他們進行了討論,與他們分享了我們迄今為止所取得的成就以及我們在連續細胞系製造過程中的進展,這似乎確實引起了一些興趣。最終,我們必須看看他們如何回應。

  • The process of submitting a response to the RFI is closed on May 25. So right now, and still different companies are submitting, again, we submitted our very, very quickly. We were prepared for it, et cetera. And so, we're in the waiting. We still are engaging an outreach and discussion with various federal government individuals, some of whom are part of Project Next Gen and some who are part of related entities, making sure that they are aware, not only of GeoVax, but of what we have already accomplished, where we are in the process of clinical development, and what our plans are in terms of moving forward with this new manufacturing system.

    向 RFI 提交回复的流程已於 5 月 25 日結束。所以現在,還有不同的公司在提交,我們再次非常非常快地提交了我們的回复。我們為此做好了準備,等等。所以,我們在等待。我們仍在與各種聯邦政府個人進行外展和討論,其中一些人是下一代項目的一部分,一些人是相關實體的一部分,確保他們不僅了解 GeoVax,而且了解我們已經擁有的東西完成,我們在臨床開發過程中的位置,以及我們在推進這個新製造系統方面的計劃。

  • So I hope that answers the questions. So, the answer is yes, we have that dialogue. But we're also working through the process they've laid out also, but we're also working directly through other avenues to make sure we reach out to people.

    所以我希望這能回答問題。所以,答案是肯定的,我們進行了對話。但我們也在努力完成他們也制定的流程,但我們也在通過其他途徑直接工作,以確保我們接觸到人們。

  • Jason Kolbert - Analyst

    Jason Kolbert - Analyst

  • Perfect. Thank you. And David, if you don't mind, can you just touch on the sequence of milestones. I know you did mention it earlier, but given your CFO's comments, I'd just like to understand how they lay out over the next 12 months?

    完美的。謝謝。大衛,如果你不介意的話,你能談談里程碑的順序嗎?我知道你之前確實提到過,但鑑於你的首席財務官的評論,我只想了解他們在未來 12 個月內的佈局?

  • David Dodd - Chairman, President & CEO

    David Dodd - Chairman, President & CEO

  • So with Gedeptin, now, we have 8 of the 10 patients in the program. We had expanded it, as you recall, to three sites. And we anticipate bringing in the last two for this initial a 10-patient trial. That's the one that's been funded fully by the FDA. Our plan is to have that accomplished sooner rather than later, clearly yet this year to review the data, we've already been in discussions with our advisors about the expanded program that we would propose to the FDA. So, we anticipate yet this year to review the data, to discuss the data, and hopefully initiate it and have initial discussions with the FDA.

    所以有了 Gedeptin,現在,我們有 10 名患者中的 8 名參與了該項目。如您所知,我們已將其擴展到三個站點。我們預計將在最初的 10 名患者試驗中引入最後兩個。那是一個由 FDA 全額資助的項目。我們的計劃是盡快完成這項工作,顯然今年要審查數據,我們已經與我們的顧問討論了我們將向 FDA 提議的擴展計劃。因此,我們預計今年將審查數據,討論數據,並希望啟動它並與 FDA 進行初步討論。

  • Jason Kolbert - Analyst

    Jason Kolbert - Analyst

  • Perfect. Thank you so much --

    完美的。太感謝了 -

  • David Dodd - Chairman, President & CEO

    David Dodd - Chairman, President & CEO

  • We really -- we appreciate all these updates.

    我們真的——我們感謝所有這些更新。

  • Jason Kolbert - Analyst

    Jason Kolbert - Analyst

  • Okay, Thank you.

    好的謝謝。

  • Operator

    Operator

  • Vernon Bernardino, HC Wainwright.

    弗農伯納迪諾,HC 溫賴特。

  • Vernon Bernardino - Analyst

    Vernon Bernardino - Analyst

  • Hi, David, and Mark, everyone. Thanks for taking my question, and congrats on the process, especially with the manufacturing for MVA based vaccines and immunotherapies. It's a really important piece. A lot of my questions were asked by Jason, so I don't have anything other than -- just wanted to get your take, as you know, on the Federal Register, did you see as ACIP is going to have a meeting next month -- and one of the things, David, intend to discuss is Mpox or formally called monkeypox.

    大家好,大衛和馬克。感謝您提出我的問題,並祝賀這一過程,特別是基於 MVA 的疫苗和免疫療法的製造。這是一個非常重要的作品。 Jason 問了我很多問題,所以我沒有別的,只是想听聽你對《聯邦公報》的看法,你看到 ACIP 下個月要開會了嗎-- 大衛打算討論的其中一件事是 Mpox 或正式名稱為猴痘。

  • I was wondering if there's anything there as well as the other vaccine recommendations that they may have that could help you with your programs. What are you looking for, and what made you change it, as far as your programs are concerned, such the candidates could be advanced into the clinic in the near term future such as next 6 to 12 months?

    我想知道是否有任何東西以及他們可能擁有的其他疫苗建議可以幫助您完成您的計劃。你在尋找什麼,是什麼讓你改變它,就你的計劃而言,這樣的候選人可以在短期內(比如接下來的 6 到 12 個月)進入診所?

  • David Dodd - Chairman, President & CEO

    David Dodd - Chairman, President & CEO

  • Thank you, [Vernon] We're not aware of anything on that agenda that relates to what we're doing, but I'm going to ask John Sharkey to weigh in, since he's leading our MVA vaccine program. That is specifically what we in-licensed or acquired the rights to and are developing against Mpox and smallpox. John?

    謝謝你,[Vernon] 我們不知道該議程上有任何與我們正在做的事情相關的內容,但我會請 John Sharkey 參與,因為他正在領導我們的 MVA 疫苗計劃。這就是我們針對 Mpox 和 smallpox 授權或獲得權利並正在開發的內容。約翰?

  • John Sharkey - VP, Business Development

    John Sharkey - VP, Business Development

  • Sure. Hey, thanks for the question, Vernon. As we've mentioned before, our desire for the MVA is -- the monkeypox and smallpox has become US based manufacturer, eventually switch to continuous cell-line platform, so that we can manufacture on large scale in quick time frames.

    當然。嘿,謝謝你的問題,弗農。正如我們之前提到的,我們對 MVA 的渴望是——猴痘和天花已經成為美國的製造商,最終轉向連續的細胞系平台,這樣我們就可以在快速的時間內大規模生產。

  • Our regulatory strategy, as we mentioned, is that there's a number of countries outside the US that were unable -- were or are still unable to get access to the MVA vaccine. And so we see a market opportunity there. Our strategy right now is engaging. We have retained an outside regulatory consulting group that's well-known, respected in this space.

    正如我們所提到的,我們的監管策略是美國以外的許多國家無法——曾經或仍然無法獲得 MVA 疫苗。所以我們在那裡看到了市場機會。我們現在的策略是吸引人。我們保留了一個在該領域廣為人知、受人尊敬的外部監管諮詢小組。

  • And we're putting together a strategy to see what regulatory agencies around the world would be open to working with us, given the known safety and efficacy of MVA against smallpox and monkeypox to put together as we refer an [expedited] pathway, whether that's an accelerated pathway or that's a biosimilar, whatever it is. What that (inaudible) will be available to get approval from a recognized regulatory agency that we could then use with NGOs and other countries, that will be confident with that approval, would now allow use of MVA within their territories.

    我們正在製定一項戰略,看看世界各地的哪些監管機構願意與我們合作,考慮到已知的 MVA 抗天花和猴痘的安全性和有效性,將我們提到的 [加速] 途徑放在一起,無論是加速途徑或生物仿製藥,無論它是什麼。什麼(聽不清)將可用於獲得公認的監管機構的批准,然後我們可以與非政府組織和其他國家一起使用,這些國家將對該批准充滿信心,現在將允許在其領土內使用 MVA。

  • So, that's our general strategy. Right now, we're in the -- we're past the information gathering. We're beginning now to reach out to regulatory agency to engage discussions with them about our thinking, and how we would like to work with them to accelerate approval process to get this product to the market, because we believe there is a need in many parts of the world.

    所以,這是我們的總體戰略。現在,我們處於 - 我們已經過去了信息收集。我們現在開始聯繫監管機構,與他們討論我們的想法,以及我們希望如何與他們合作以加快審批流程,將此產品推向市場,因為我們相信許多人都需要世界的一部分。

  • Vernon Bernardino - Analyst

    Vernon Bernardino - Analyst

  • Terrific. Thanks for that information. And as a follow up, do you anticipate making further progress and announcing progress on those kinds of things you might get as far as what the governments need outside the US, outside the western world such as Europe, later this year?

    了不起。感謝您提供該信息。作為後續行動,您是否預計今年晚些時候在美國以外、歐洲等西方世界之外的政府需要的事情上取得進一步進展並宣布取得進展?

  • John Sharkey - VP, Business Development

    John Sharkey - VP, Business Development

  • Yes. It will definitely be within the next [two] months. We we've looked at this for a couple of months now, and kind of reading the regulations of working with our consultants. We've mapped out proposed strategies that we want to present to them, as well as engage them and see what their thinking is on how we might adjust them or tweak them or is there a pathway we may not be familiar with that they would be willing to work with us on. So, this is going to move quickly forward into the engagement phase with the regulators.

    是的。肯定會在接下來的[兩個]月內。我們已經研究了幾個月,並且閱讀了與我們的顧問合作的規定。我們已經制定了我們想要向他們展示的建議策略,並讓他們參與進來,看看他們對我們如何調整或微調他們的想法是什麼,或者是否有他們可能不熟悉的途徑願意與我們合作。因此,這將迅速進入與監管機構的接觸階段。

  • Vernon Bernardino - Analyst

    Vernon Bernardino - Analyst

  • Perfect. That's very exciting. Looking forward to further news on that front. And thanks for taking my question.

    完美的。這非常令人興奮。期待這方面的進一步消息。感謝您提出我的問題。

  • John Sharkey - VP, Business Development

    John Sharkey - VP, Business Development

  • You're welcome.

    不客氣。

  • Operator

    Operator

  • Kumar Raja, Roth Capital.

    羅斯資本的 Kumar Raja。

  • Kumaraguru Raja - Analyst

    Kumaraguru Raja - Analyst

  • Thanks for taking my questions, and congratulations on the progress. Just a follow-up on Gedeptin. Will you'll be enrolling more than 10 patients if they are screened by Q2? And in terms of the interactions with the regulator, following those interactions, how quickly do you think you can expand the program, if expectation that in the expanded program, there will be arm which will include a checkpoint inhibitor? Thank you.

    感謝您提出我的問題,並祝賀您取得的進展。只是 Gedeptin 的後續行動。如果在 Q2 進行篩查,你們是否會招募超過 10 名患者?在與監管機構的互動方面,在這些互動之後,您認為您可以多快擴展該程序,如果期望在擴展的程序中,會有一個包含檢查點抑製劑的手臂?謝謝。

  • David Dodd - Chairman, President & CEO

    David Dodd - Chairman, President & CEO

  • Okay. I'm going to ask Kelly Mackey, our Chief Medical Officer to provide some guidance on there. And then he and John Sharkey may want to discuss the status related to what is currently still preclinical, but with immune checkpoint inhibitors. Kelly?

    好的。我將請我們的首席醫療官凱利·麥基 (Kelly Mackey) 就此提供一些指導。然後他和 John Sharkey 可能想討論與目前仍處於臨床前但與免疫檢查點抑製劑相關的狀態。凱莉?

  • Kelly McKee - Chief Medical Officer

    Kelly McKee - Chief Medical Officer

  • Yes. Hi. With regard to whether or not we would continue enrolling after we hit our current target of 10 patients, I think that's a bit of an open question. We don't have any current plans to do that, but I think it would probably depend on the dynamics of enrollment.

    是的。你好。關於我們是否會在達到目前的 10 名患者目標後繼續招募,我認為這是一個懸而未決的問題。我們目前沒有任何計劃這樣做,但我認為這可能取決於入學的動態。

  • If we have an opportunity to add one or two additional patients within a reasonable timeframe, for example, if there are -- if our investigators have people identified that are waiting and willing and available to enroll without delaying the final closure of the study, then we would probably consider that. But I think, at the present time, we really are targeting 10 total patients for this study, get it closed up to get the data reviewed in front of the regulators for furthering our and discussions.

    如果我們有機會在合理的時間範圍內增加一兩個額外的患者,例如,如果我們的研究人員確定了正在等待並願意並且可以在不延遲研究最終結束的情況下註冊的人,那麼我們可能會考慮這一點。但我認為,目前,我們確實針對 10 名患者進行這項研究,將其關閉,以便在監管機構面前審查數據,以進一步開展我們的討論。

  • David Dodd - Chairman, President & CEO

    David Dodd - Chairman, President & CEO

  • John, do you want to comment some on the ICIs and where that stands, and what we [learn]

    約翰,你想對 ICI 及其現狀以及我們 [學習] 發表一些評論嗎?

  • John Sharkey - VP, Business Development

    John Sharkey - VP, Business Development

  • Sure. So as David said, it's still in preclinical that be (technical difficulty) the scheduling of the ICIs in combination with Gedeptin, I think and Kelly can speak to it more, is still somewhat open. Our focus right now is to see the data from the 10 patients, see what's actually there, have the discussions with the agency on what we could do to get Gedeptin approved as a monotherapy.

    當然。正如 David 所說,ICI 與 Gedeptin 結合的時間安排仍處於臨床前階段(技術困難),我認為 Kelly 可以更多地談論它,仍然有些開放。我們現在的重點是查看 10 名患者的數據,了解實際情況,與該機構討論我們可以做些什麼來讓 Gedeptin 被批准為單一療法。

  • At what point we would now win the ICI, with that, I think is going to be very dependent on how that discussion goes with the regulatory agency. Preclinical data is highly suggestive, because [always] never show as you go from a small animal to humans that there will be a synergistic effect between the two. But that's the discussions we have with the regulators to decide how -- in concert with them, how would you want to proceed? And I'll let Kelly add any other insight to that.

    在什麼時候我們現在將贏得 ICI,我認為這將非常取決於與監管機構的討論如何進行。臨床前數據非常具有啟發性,因為從小動物到人類,[總是]永遠不會表明兩者之間會產生協同效應。但這就是我們與監管機構進行的討論,以決定如何 - 與他們一起,你想如何進行?我會讓凱利對此添加任何其他見解。

  • Kelly McKee - Chief Medical Officer

    Kelly McKee - Chief Medical Officer

  • Well, only that I think we're very optimistic that this is going to be a sort of major advancement for our program. You're well aware of the success that Moderna and Merck have with -- in acral melanomas. There was some recent data on bladder cancer, where they have a oncolytic virus paired up with a checkpoint inhibitor, which in many ways is sort of similar to the concept or conceptually similar to what we've got in mind, exposing neoantigens.

    好吧,只是我認為我們非常樂觀,這將成為我們計劃的一種重大進步。你很清楚 Moderna 和默克在肢端黑色素瘤方面取得的成功。最近有一些關於膀胱癌的數據,他們將溶瘤病毒與檢查點抑製劑配對,這在很多方面與我們想到的概念或概念上相似,暴露了新抗原。

  • And so, I think we're optimistic that offers a potential for us to target patients with head and neck cancer in earlier stages of the disease, as well as other solid tumor types with this approach. So we're going to move as quickly as we can to advance this. But again, it's going to depend on our discussions with the regulators abut about what's required for us to get there.

    因此,我認為我們樂觀地認為,我們有可能通過這種方法針對處於疾病早期階段的頭頸癌患者以及其他實體瘤類型。因此,我們將盡快採取行動推進這一進程。但同樣,這將取決於我們與監管機構的討論,以及我們實現目標所需的條件。

  • Kumaraguru Raja - Analyst

    Kumaraguru Raja - Analyst

  • Okay. That's great. Thanks so much.

    好的。那太棒了。非常感謝。

  • Operator

    Operator

  • James Molloy, Alliance Global Partners.

    James Molloy,Alliance Global Partners。

  • Laura Suriel - Analyst

    Laura Suriel - Analyst

  • Hi, this is Laura in for Jim Molloy. Thank you for taking our questions. So, for enrollment for the Phase 1/2 trial of Gedeptin expected to be completed on soon this quarter. When should we anticipate a last patient in or last patient visit announcement? And then also on top of the ICIs that were already mentioned in the previous question, what might the protocol for the subsequent expanded trial look like? Or will this be determined following the completion of the ongoing Phase 1/2 trial?

    嗨,我是 Jim Molloy 的 Laura。感謝您接受我們的提問。因此,Gedeptin 1/2 期試驗的註冊預計將於本季度很快完成。我們應該在什麼時候預測最後一位患者或最後一位患者就診公告?然後除了上一個問題中已經提到的 ICI 之外,後續擴展試驗的方案可能是什麼樣的?或者這將在正在進行的 1/2 期試驗完成後確定?

  • David Dodd - Chairman, President & CEO

    David Dodd - Chairman, President & CEO

  • Let me just comment. Once we have the 10th patient enrolled, there are five cycles. So it's basically five months. So that gives you a time period depending on when that 10th patient is enrolled, then we look forward to then through the five cycles and then the evaluation of the data. So, if we're successful when they come in -- as the sooner they come in, then the more likely is we'll be able to see the results of the completion through the five cycles yet this year. I mean, that's just the [metrics] so it depends on that. And that's what we're working on.

    讓我發表評論。一旦我們招募了第 10 名患者,就有五個週期。所以基本上是五個月。因此,這給了你一個時間段,具體取決於第 10 名患者何時入組,然後我們期待著通過五個週期,然後對數據進行評估。所以,如果我們在他們進來時取得成功——因為他們進來得越早,那麼我們就越有可能在今年看到五個週期的完成結果。我的意思是,那隻是[指標],所以它取決於那個。這就是我們正在努力的。

  • Obviously when we expanded to the three sites from the initial one that and open up greater opportunity to be able to move this along and complete this initial 10 patient study. There's been no discussions about clinical protocol related to in conjunction or in combo therapy with ICIs, mainly because our focus is really on determining if there's a basis which we hope to see from the 10th patient to then look at an expanded Phase 2 trial. And that may be anywhere depending on what the final protocol structure, but less, I think, we're thinking less than 100 patients and all. But again, that will be based upon the discussions we have a review of the data. I'll ask if Kelly, I'd like to add anything at this point.

    顯然,當我們從最初的一個站點擴展到三個站點時,並開闢了更大的機會來推動這一點並完成最初的 10 名患者研究。目前還沒有關於與 ICI 聯合或聯合治療相關的臨床方案的討論,主要是因為我們的重點實際上是確定是否有我們希望從第 10 名患者那裡看到的基礎,然後再研究擴大的 2 期試驗。這可能在任何地方,具體取決於最終協議結構,但我認為,我們考慮的患者少於 100 名。但同樣,這將基於我們對數據進行審查的討論。我會問 Kelly,現在我想補充什麼嗎?

  • Kelly McKee - Chief Medical Officer

    Kelly McKee - Chief Medical Officer

  • No, I think that that pretty much summarizes it. Just to note that enrolling these patients is not as simple and straightforward as it might appear on the surface. Remember that our trial is targeting patients with essentially the terminal stages of their disease. So it's more or less palliative therapy for these folks. And in order for us to find eligible patients, they have to have exhausted all of their other therapeutic options, and they have to be healthy enough to enroll in a study that's going to take them through, again, six months -- five, six months of treatment. And we found that those patients tend to be few and far between.

    不,我認為這幾乎概括了它。請注意,招募這些患者並不像表面上看起來那麼簡單直接。請記住,我們的試驗主要針對處於疾病末期的患者。所以這對這些人來說或多或少是姑息療法。為了讓我們找到符合條件的患者,他們必須用盡所有其他治療選擇,而且他們必須足夠健康才能參加一項將讓他們再次經歷六個月——五、六個月的研究幾個月的治療。我們發現這些患者往往很少而且相距甚遠。

  • And so we're trying as hard as we can to get eligible patients identified and enrolled. But it's taking a little bit longer than we had initially anticipated. But as David said, I mean once we get this study fully enrolled, get our data analyzed, and in front of the agency, and have our discussions about what they would like to see for us to continue in this patient population and then what they would also like to see for us to take a sort of a parallel approach with a checkpoint inhibitor or potentially other combination strategies. We'll just have to wait to see how those discussions go, I think.

    因此,我們正在盡最大努力確定並招募符合條件的患者。但這比我們最初預期的要長一點。但正如大衛所說,我的意思是,一旦我們完成這項研究,對我們的數據進行分析,並在機構面前進行討論,並討論他們希望我們繼續在這個患者群體中看到什麼,然後他們會做什麼還希望看到我們採用一種與檢查點抑製劑或其他潛在組合策略並行的方法。我想,我們只需要等待,看看這些討論的進展情況。

  • David Dodd - Chairman, President & CEO

    David Dodd - Chairman, President & CEO

  • Thank you. And it'll be --

    謝謝。它將是——

  • Laura Suriel - Analyst

    Laura Suriel - Analyst

  • Got it --

    知道了 -

  • David Dodd - Chairman, President & CEO

    David Dodd - Chairman, President & CEO

  • If data supported so it will be a big priority for sure, because we've been encouraged by the limited data that was in the Phase 1, and we are happy that we now have eight of them, but we need to get the 10. We need to analyze the data and reach agreement on an expanded Phase 2 program, and then we'll go full out with expanded sites, and try to do that as quickly as possible, and then in parallel also with the other trials. So we'll keep you updated, though. Thank you.

    如果有數據支持,那肯定會成為重中之重,因為我們對第一階段有限的數據感到鼓舞,我們很高興現在有 8 個,但我們需要獲得 10 個。我們需要分析數據並就擴展的第 2 階段計劃達成一致,然後我們將全面擴展站點,並嘗試盡快完成,然後與其他試驗同時進行。不過,我們會及時通知您。謝謝。

  • Laura Suriel - Analyst

    Laura Suriel - Analyst

  • Understood. Also, just on also just one more question. So, for your CM04S1 candidate, as mentioned with the shifting landscape for COVID-19 and as new variants emerge, does this change in any way the development for this candidate moving forward? And then, do you also think it may work equally as well against these newer streams?

    明白了。另外,還有一個問題。那麼,對於您的 CM04S1 候選人,正如 COVID-19 的變化和新變種的出現所提到的,這是否以任何方式改變了該候選人的發展?然後,您是否還認為它對這些較新的流也同樣有效?

  • David Dodd - Chairman, President & CEO

    David Dodd - Chairman, President & CEO

  • Well, we don't know the latter until we have some testing, and we have evidence of it now. The concept of targeting both the antibody side and T-cells to the spike protein and nucleic acids is done to hopefully achieve a broader, more robust type of protection, and where the antibody alone isn't sufficient more or less that we can more than compensate for that by incorporating with the T-cells. And so that's what we're hoping to demonstrate.

    好吧,在我們進行一些測試之前我們不知道後者,我們現在有證據。將抗體側和 T 細胞同時靶向刺突蛋白和核酸的概念旨在實現更廣泛、更強大的保護類型,而單靠抗體或多或少不足以滿足我們的需求通過與 T 細胞結合來彌補這一點。這就是我們希望展示的。

  • We did announce recently we had added the rights in terms of related to omicron, it to be a license agreement that we have. And we will continue to look at the current vaccine, and CM04S1, and also if we decide that we want to do some alternate modifications because of variants that, again, to evolve that they may be significantly different. So, we just have to stay attuned to that.

    我們最近確實宣布我們已經添加了與 omicron 相關的權利,這是我們擁有的許可協議。我們將繼續研究當前的疫苗和 CM04S1,如果我們決定要進行一些替代修改,因為這些變體再次進化,它們可能會有很大的不同。所以,我們只需要保持適應。

  • One thing we do know is that the modifications that have been going on with the existing vaccines continue to provide us with the sort of inadequate vaccines for the breadth of populations, and especially, for those individuals with compromised immune system. And as we've discussed before, we're focusing very heavily to differentiate by going after the populations that are underserved or not adequately served by the current authorized vaccines. And that's the basis behind the structure of CM04S1. And we believe that the initial data we're seeing shows that it is making a much broader difference. So we'll keep you updated as data comes forward.

    我們確實知道的一件事是,對現有疫苗進行的修改繼續為我們提供適合廣大人群的疫苗,尤其是那些免疫系統受損的人。正如我們之前討論過的那樣,我們非常注重通過追踪當前授權疫苗服務不足或服務不足的人群來實現差異化。這就是 CM04S1 結構背後的基礎。我們相信,我們看到的初步數據表明它正在產生更廣泛的影響。因此,隨著數據的出現,我們會及時通知您。

  • Laura Suriel - Analyst

    Laura Suriel - Analyst

  • Got it. Thank you for taking the questions.

    知道了。感謝您提出問題。

  • David Dodd - Chairman, President & CEO

    David Dodd - Chairman, President & CEO

  • Thank you.

    謝謝。

  • Operator

    Operator

  • Robert LeBoyer, Noble Capital Markets.

    Noble Capital Markets 的羅伯特·勒博耶 (Robert LeBoyer)。

  • Robert LeBoyer - Analyst

    Robert LeBoyer - Analyst

  • Thank you. Well, John and Kelly gave a very good answer to my question about the ICI inhibitors and combinations. But the question I still have is about the timing of an announcement for Gedeptin. And based on the earlier comments with the five cycles and looking at the calendar, it looks as if an announcement might come maybe at the end of the year, but more likely first quarter? Is that what you're thinking?

    謝謝。好吧,約翰和凱利對我關於 ICI 抑製劑和組合的問題給出了很好的答案。但我仍然有一個問題是關於 Gedeptin 的發佈時間。根據之前對五個週期的評論並查看日曆,看起來公告可能會在今年年底發布,但更有可能在第一季度發布?你是這麼想的嗎?

  • David Dodd - Chairman, President & CEO

    David Dodd - Chairman, President & CEO

  • Yes, Robert, depending on, again -- obviously, when that 10th patient comes in, et cetera, then we -- you know, it's just like we've always done on trials when you know the length of the evaluation period, you just map that out. So, we're as anxious as everyone to get these last two patients in. But, as Kelly mentioned, as he said, these are patients who have failed everything. There's not anticipated survival from this type of therapy. It is really, can we affect the tumors and improve their quality of life during this terminal period of their lives with when they on palliative care.

    是的,羅伯特,再次取決於——顯然,當第 10 名患者進來時,等等,然後我們——你知道,就像我們在試驗中一直做的那樣,當你知道評估期的長度時,你只是映射出來。所以,我們和每個人一樣急於讓最後兩名患者入院。但是,正如凱利所說,正如他所說,這些患者的一切都失敗了。這種療法沒有預期的存活率。真的,當他們接受姑息治療時,我們能否在他們生命的最後階段影響腫瘤並改善他們的生活質量。

  • Robert LeBoyer - Analyst

    Robert LeBoyer - Analyst

  • Okay, great. Thank you very much.

    好的,太好了。非常感謝。

  • David Dodd - Chairman, President & CEO

    David Dodd - Chairman, President & CEO

  • Thank you.

    謝謝。

  • Operator

    Operator

  • There are no further questions at this time. I'd like to turn the call back over to David Dodd for closing remarks.

    目前沒有其他問題。我想將電話轉回給 David Dodd 以作結束語。

  • David Dodd - Chairman, President & CEO

    David Dodd - Chairman, President & CEO

  • Thank you, and thank you, everyone, for participating in this update call and sharing our achievements progress and outlook. We greatly appreciate your interest. Our biggest focus and greatest challenge is to see an accelerated pace of patient enrollment, getting to data milestones sooner, so we can talk about greater database of results. And We'll continue to stay focused on that, that's what we're focused on, Gedeptin, CM04S1, and the other development programs we've talked about today.

    感謝,也感謝大家參與此次更新電話會議並分享我們的成就進展和展望。我們非常感謝您的關注。我們最大的關注點和最大的挑戰是加快患者登記的步伐,更快地達到數據里程碑,這樣我們就可以討論更大的結果數據庫。我們將繼續專注於此,這就是我們關注的重點,Gedeptin、CM04S1 以及我們今天討論的其他開發項目。

  • Our goal is that by doing this, we'll be able to build shareholder value, stakeholder value, and of course, providing a motivating career development opportunities for our team. We want to thank our Board of Directors, our staff, our advisers, and all other parties, including some of you who have been asking questions, who continue to support, advise, and guide us towards achieving success.

    我們的目標是,通過這樣做,我們將能夠建立股東價值、利益相關者價值,當然,還可以為我們的團隊提供激勵性的職業發展機會。我們要感謝我們的董事會、我們的員工、我們的顧問和所有其他各方,包括你們中的一些人,他們一直在提出問題,他們繼續支持、建議和指導我們取得成功。

  • With that, we wish you all a great evening. Have a great weekend. Great (inaudible). And again, thank you for your interest in GeoVax.

    至此,祝大家度過一個愉快的夜晚。週末愉快。太好了(聽不清)。再次感謝您對 GeoVax 的關注。

  • Operator

    Operator

  • This concludes today's GeoVax call. We thank you for your participation. You may now disconnect.

    今天的 GeoVax 電話會議到此結束。我們感謝您的參與。您現在可以斷開連接。