GeoVax Labs Inc (GOVX) 2022 Q4 法說會逐字稿

Good afternoon, and welcome, everyone, to the GeoVax fourth quarter full year 2022 corporate update call. My name is Diego, and I will facilitate today's call. With me today are David Dodd, Chairman and CEO, Mark Reynolds, Chief Financial Officer, Mark Newman, Chief Scientific Officer, Dr. Kelly Mckee, Chief Medical Officer, and Dr. John Sharkey, Vice President Business Development. (Operator Instructions)

下午好，歡迎大家參加 GeoVax 2022 年第四季度全年公司更新電話會議。我的名字是 Diego，我將主持今天的電話會議。今天和我在一起的有董事長兼首席執行官 David Dodd、首席財務官 Mark Reynolds、首席科學官 Mark Newman、首席醫療官 Kelly Mckee 博士和業務發展副總裁 John Sharkey 博士。 （操作員說明）

Please note this conference is being recorded. I will now turn the conference over to our host, Gabby DeGravina of CG Capital. Thank you. You may begin.

請注意，此會議正在錄製中。我現在將會議轉交給我們的主持人，CG Capital 的 Gabby DeGravina。謝謝。你可以開始了。

Thank you. Please note the following certain statements in this presentation may constitute forward-looking statements within the meaning of the Private Securities Litigation Reform Act. These statements are based on management's current expectations and are subject to uncertainty and changes in circumstances. Actual results may differ materially from those included in these statements due to a variety of factors including whether GeoVax can develop and manufacture vaccines at the desired characteristics in a timely manner, GeoVax's vaccines will be safe for human use, GeoVax's vaccines will effectively prevent targeted infections in humans, GeoVax's vaccines will receive regulatory approvals necessary to be licensed and marketed, GeoVax raises required capital to complete vaccine development, 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.

謝謝。請注意，本演示文稿中的以下某些陳述可能構成《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。由於多種因素，包括 GeoVax 是否能夠及時開發和製造所需特性的疫苗，GeoVax 的疫苗對人類使用是安全的，GeoVax 的疫苗將有效預防靶向感染，實際結果可能與這些聲明中包含的結果存在重大差異在人類中，GeoVax 的疫苗將獲得許可和銷售所需的監管批准，GeoVax 籌集完成疫苗開發所需的資金，開發可能比 GeoVax 產品更有效或更易於使用的競爭產品，GeoVax 將能夠進入進入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.

現在我很高興介紹 GeoVax 的董事長兼首席執行官 David Dodd。

Good afternoon, and thank you for participating in the GeoVax corporate update call. Fourth quarter 2022 represented continued progress for GeoVax as we advance the Phase 2 clinical programs in support of Gedeptin, our promising cancer therapy for patients with advanced head and neck cancers, and GEO-CM04S1, our next-generation COVID-19 vaccine focused on the unmet needs of immunocompromised patients. We also continue to progress our overall development stage programs. This includes our GeoVax MUC1 immunotherapy, currently in IND supportive studies. Also, the preclinical studies evaluating Gedeptin in conjunction with immune checkpoint inhibitors continue to be encouraging with relevant data expected this year.

下午好，感謝您參與 GeoVax 公司更新電話會議。 2022 年第四季度代表 GeoVax 繼續取得進展，因為我們推進了 2 期臨床計劃以支持 Gedeptin（我們對晚期頭頸癌患者有希望的癌症治療）和 GEO-CM04S1（我們的下一代 COVID-19 疫苗，專注於免疫功能低下患者未滿足的需求。我們還繼續推進我們的整體發展階段計劃。這包括我們的 GeoVax MUC1 免疫療法，目前正在進行 IND 支持性研究。此外，評估 Gedeptin 與免疫檢查點抑製劑聯合使用的臨床前研究繼續令人鼓舞，相關數據有望於今年公佈。

Throughout 2022, we strengthened our balance sheet during a very difficult investment environment, especially for the biotech industry. As a result of our successful financings last year, we've expanded our current clinical programs to include additional sites while also adding near term opportunities related to our manufacturing processes and the additional oncology programs.

整個 2022 年，我們在非常困難的投資環境中加強了資產負債表，尤其是在生物技術行業。由於我們去年成功融資，我們擴大了當前的臨床項目以包括更多地點，同時還增加了與我們的製造工藝和其他腫瘤學項目相關的近期機會。

Recently, we announced the expansion of our Gedeptin Phase 2 clinical program with the activation of patient enrollment into two additional sites at Emory University and Thomas Jefferson University. For our COVID-19 vaccine program, we implemented a novel mobile clinical research facility in Claremont, California to support our Phase 2 COVID-19 vaccine booster trial. Additionally, multiple sites are in the process of joining our Phase 2 COVID-19 trial among immunocompromised patients, including some potential sites outside the US. There is significant interest in participating in the evaluation of our novel COVID-19 vaccine targeting the high risk immunocompromised patient populations.

最近，我們宣布擴大我們的 Gedeptin 2 期臨床計劃，並在埃默里大學和托馬斯杰斐遜大學的另外兩個地點激活患者註冊。對於我們的 COVID-19 疫苗計劃，我們在加利福尼亞州克萊蒙特實施了一個新型移動臨床研究設施，以支持我們的 2 期 COVID-19 疫苗加強試驗。此外，多個地點正在加入我們在免疫功能低下患者中進行的 2 期 COVID-19 試驗，包括美國以外的一些潛在地點。人們對參與針對高風險免疫功能低下患者群體的新型 COVID-19 疫苗的評估非常感興趣。

During the fourth quarter, we also announced the acquisition of the rights from the NIH allowing GeoVax to develop and commercialize their MVA as a vaccine against monkeypox or impox and smallpox. Our intent is to be the first and primary US based supplier of the GeoVax MVA vaccine against impox and smallpox, resulting in expanded supply and access worldwide, especially related to low and/* middle income countries which have consistently experienced significant difficulty in supply of many critical vaccines and therapies.

在第四季度，我們還宣布從 NIH 獲得權利，允許 GeoVax 開發和商業化他們的 MVA 作為針對猴痘或 impox 和天花的疫苗。我們的目標是成為第一家和主要的美國 GeoVax MVA 疫苗供應商，以對抗水痘和天花，從而擴大全球範圍內的供應和獲取，特別是與低收入和/*中等收入國家相關，這些國家在許多疫苗的供應方面一直存在重大困難關鍵疫苗和療法。

Finally, we recently announced our successful progress towards becoming the first vaccine supplier using an avian cell line base manufacturing process, significantly expanding the yield and capacity of MVA based vaccines. This will allow us to reduce supply chain risk associated with the use of chicken eggs, and to provide the means to greatly expand production cost scale to address potential global needs, again, especially related to lower-cost alternatives for supply to the low and middle income countries.

最後，我們最近宣布我們成功地成為第一家使用禽細胞系基礎製造工藝的疫苗供應商，顯著擴大了基於 MVA 的疫苗的產量和產能。這將使我們能夠降低與使用雞蛋相關的供應鏈風險，並提供大幅擴大生產成本規模以滿足潛在全球需求的方法，尤其是與向中低端供應的低成本替代品相關的需求收入國家。

Our mission is to provide immunotherapies and vaccines that improve lives worldwide, preventing or treating some of the world's most challenging cancers and infectious diseases. Our business strategy of partnering and collaborations is anticipated to allow us to provide worldwide access to our products while providing optimal value to our stakeholders. We believe that Gedeptin, CM04S1, and our other initiatives provide significant value expansion opportunities for the company, our shareholder, and stakeholder, while providing compelling career development opportunities for the members of our team.

我們的使命是提供免疫療法和疫苗，改善全世界的生活，預防或治療世界上一些最具挑戰性的癌症和傳染病。我們的合作和協作業務戰略預計將使我們能夠在全球範圍內提供對我們產品的訪問，同時為我們的利益相關者提供最佳價值。我們相信，Gedeptin、CM04S1和我們的其他舉措為公司、我們的股東和利益相關者提供了重要的價值擴展機會，同時為我們團隊的成員提供了引人注目的職業發展機會。

As a reminder, Gedeptin is a cancer therapy currently in an expanded multisite evaluation among patients suffering from advanced head and neck cancer. The product has received orphan drug designation from the FDA and funding from the current clinical trial -- it's from the FDA orphan drugs clinical trials program. Our focus is on completing the initial 10 patient study funded by the FDA. 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 Biologics License Application filing.

提醒一下，Gedeptin 是一種癌症療法，目前正在對患有晚期頭頸癌的患者進行擴大的多中心評估。該產品已獲得 FDA 的孤兒藥物指定和當前臨床試驗的資助——它來自 FDA 孤兒藥物臨床試驗計劃。我們的重點是完成由 FDA 資助的最初的 10 名患者研究。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 討論加快生物技術許可申請備案的可能性。

We are excited about the outlook and promise of Gedeptin within advanced head and neck cancers as well as other opportunities and indications relative to the expanded use of Gedeptin. This includes the potential application of the underlying technology in conjunction with other therapies such as immune checkpoint inhibitors, and potential synergy with our internally developed GeoVax MUC1 tumor-associated antigen approach. Relative to commercialization, we anticipate partnering and collaborations in support of worldwide use, for which business development activities have been initiated.

我們對 Gedeptin 在晚期頭頸癌中的前景和前景以及與擴大使用 Gedeptin 相關的其他機會和適應症感到興奮。這包括基礎技術與免疫檢查點抑製劑等其他療法的潛在應用，以及與我們內部開發的 GeoVax MUC1 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全球使用，為此已經啟動了業務開發活動。

The vast array of unmet medical needs within oncology represents significant opportunities for GeoVax to advance novel approaches such as that of Gedeptin therapy against multiple tumors, Gedeptin in conjunction with immune checkpoint inhibitors, and the GeoVax MUC1 cancer immunotherapy approach addressing various cancer patient needs worldwide. As previously mentioned, we hold worldwide rights for the use of Gedeptin and the GeoVax tumor-associated antigen technologies and all indications. Our plans include the successful development and commercialization globally in conjunction with collaborators and partners.

腫瘤學中大量未滿足的醫療需求為 GeoVax 提供了推進新方法的重要機會，例如針對多種腫瘤的 Gedeptin 療法、Gedeptin 與免疫檢查點抑製劑的結合，以及 GeoVax MUC1癌症免疫療法，可滿足全球各種癌症患者的需求。如前所述，我們擁有使用 Gedeptin 和 GeoVax 腫瘤相關抗原技術和所有適應症的全球權利。我們的計劃包括與合作者和合作夥伴一起在全球範圍內成功開發和商業化。

GEO-CM04S1, which we refer to as CM04S1 is in Phase 2 clinical development as a COVID-19 vaccine targeting both the antibody and cellular arms of the immune system. The goal is to provide a more robust and durable protection than the currently authorized vaccines, especially for immunocompromised individuals. This vaccine holds promise over the current authorized vaccines from several critical areas of differentiation and value to various patients. CM04S1 is being developed to address those patient populations of immunocompromised individuals currently inadequately served by the authorized vaccines and the various monoclonal antibody therapies.

GEO-CM04S1，我們稱之為 CM04S1，作為針對免疫系統的抗體和細胞臂的 COVID-19 疫苗，正處於 2 期臨床開發階段。目標是提供比目前授權的疫苗更強大和持久的保護，尤其是對免疫功能低下的人。這種疫苗在幾個關鍵領域的差異化和對不同患者的價值方面比目前授權的疫苗更有希望。正在開發 CM04S1，以解決目前未得到授權疫苗和各種單克隆抗體療法充分服務的免疫功能低下個體的患者群體。

A recent article in the New England Journal of Medicine addressed the critical need to address both antibodies and T-cells relative to protection against SARS-CoV-2 infection and COVID-19. CM04S1 is specifically constructed to include a broader focus on the SARS-CoV-2 virus, including both the spike protein and the nucleocapsid protein, resulting in strong humoral and cellular immune responses. As a result, it induces strong antibody and T-cell responses. Such immune responses were validated and reported last year in the Lancet Micro publication of the Phase 1 data.

《新英格蘭醫學雜誌》最近發表的一篇文章解決了解決抗體和 T 細胞與防止 SARS-CoV-2 感染和 COVID-19 相關的迫切需要。 CM04S1 經過專門構建，更廣泛地關注 SARS-CoV-2 病毒，包括刺突蛋白和核衣殼蛋白，從而產生強烈的體液和細胞免疫反應。因此，它會誘導強烈的抗體和 T 細胞反應。這種免疫反應去年在 Lancet Micro 發表的第 1 階段數據中得到驗證和報告。

Addressing the cellular immune responses via inclusion of the nucleocapsid protein is especially critical among those patient populations who have immune systems with ablated ability to mount a response to antibody stimulation. This includes patient populations with various blood cancers, HIV, sickle cell anemia, kidney disease, autoimmune disease and others with various co-morbidities. We estimate at least 15 million such individuals in the US alone and over 200 million patients worldwide. We believe the CM04S1 has the potential to address a critical worldwide medical need and commercial opportunity. We also believe that an opportunity for an expedited regulatory path may exist for such a development program. With CM04S1, we also anticipate partnering and collaborations to occur for worldwide distribution, providing a novel vaccine and support of patients with such compromised immune systems.

通過包含核衣殼蛋白來解決細胞免疫反應在那些免疫系統對抗體刺激產生反應的能力減弱的患者群體中尤為重要。這包括患有各种血癌、艾滋病毒、鐮狀細胞性貧血、腎病、自身免疫性疾病和其他各種合併症的患者群體。我們估計僅在美國就有至少 1500 萬這樣的人，全世界有超過 2 億患者。我們相信 CM04S1 有潛力解決全球關鍵的醫療需求和商業機會。我們還認為，此類開發計劃可能存在加快監管路徑的機會。通過 CM04S1，我們還預計會在全球範圍內開展合作和協作，為免疫系統受損的患者提供新型疫苗和支持。

Regarding 2023 milestones, our focus this year includes accelerating efforts in support of the Gedeptin and CM04S1 Phase 2 clinical programs, moving the GeoVax MVA vaccine related to impox and smallpox into development, and advancing our MVA manufacturing process into operational validation. During the first half, we anticipate reporting initial clinical results of the safety lead-in for the CM04S1 immunocompromised trial. Presentations are scheduled for the World Vaccine Congress in early April, The Vaccine Summit 2023 in late May, as well as the ISAC Flow Cytometry International Meeting in late May. In addition to the recently reported site expansion of the Gedeptin study, we anticipate reviewing initial data later this year.

關於 2023 年的里程碑，我們今年的重點包括加快支持 Gedeptin 和 CM04S1 2 期臨床項目的工作，將與痘和天花相關的 GeoVax MVA 疫苗投入開發，並將我們的 MVA 製造工藝推進到操作驗證。在上半年，我們預計會報告 CM04S1 免疫功能低下試驗的安全導入的初步臨床結果。計劃在 4 月初的世界疫苗大會、5 月下旬的 2023 年疫苗峰會以及 5 月下旬的 ISAC 流式細胞術國際會議上發表演講。除了最近報告的 Gedeptin 研究的站點擴展之外，我們預計將在今年晚些時候審查初始數據。

Also this year, we anticipate reporting further preclinical information related to the use of the Gedeptin top technology used in conjunction with immune checkpoint inhibitors. Furthermore, we intend to provide updates relative to IND supportive studies of our advance in GeoVax MUC1 tumor-associated antigen therapy. In early June, our team will be actively participating in ASCO 2023.

同樣在今年，我們預計會報告與使用 Gedeptin 頂級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。此外，我們打算提供與我們在 GeoVax MUC1 腫瘤相關抗原治療方面取得進展的 IND 支持性研究相關的更新。 6 月初，我們的團隊將積極參加 ASCO 2023。

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

2022 年期間，我們加強了資產負債表，在許多生物技術公司實施休假計劃和/或人員休假期間增加了 3700 萬美元。我們認為我們的資本開發成功反映了投資者對 GeoVax 價值和增長機會的支持和信念。我們繼續收到與資本投資開發相關的強烈興趣，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，並實現我們當前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's 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 的首席財務官馬克·雷諾茲 (Mark Reynolds)，讓他回顧一下我們最近的業績和財務狀況。標記？

Thank you, David, starting with our income statement. The first thing to note is the lower grant revenues reported during 2022 as compared to 2021, which is reflective of the wind down of our grants from the US Army and (inaudible) for our [loss of fever] and COVID-19 preclinical program as we focused attention on our clinical programs. We do, however, intend to seek additional non-dilutive government funding for our preclinical development programs in the future.

謝謝你，大衛，從我們的損益表開始。首先要注意的是，與 2021 年相比，2022 年報告的贈款收入較低，這反映了我們從美國陸軍獲得的贈款逐漸減少，以及（聽不清）我們的 [退燒] 和 COVID-19 臨床前計劃我們將注意力集中在我們的臨床項目上。但是，我們確實打算在未來為我們的臨床前開發計劃尋求額外的非稀釋性政府資金。

Research and development expenses were $9.1 million for 2022 versus $15.6 million for 2021, representing a decrease of $6.4 million. It should be noted, however, that the '21 expense included $12.3 million of license fees and other upfront costs related to our licenses, our CM04S1 and Gedeptin. Excluding these costs, our R&D expense actually increased by $5.9 million. These increases were planned and expected as they were associated with new clinical trial activity for CM04S1 and Gedeptin, including manufacturing costs for clinical trial materials. The increase is also reflective of higher personnel and consulting costs as we stacked up earlier in the year.

2022 年的研發費用為 910 萬美元，而 2021 年為 1560 萬美元，減少了 640 萬美元。然而，應該注意的是，21 年的費用包括 1230 萬美元的許可費和與我們的許可、CM04S1 和 Gedeptin 相關的其他前期成本。排除這些成本，我們的研發費用實際上增加了 590 萬美元。這些增加是計劃和預期的，因為它們與 CM04S1 和 Gedeptin 的新臨床試驗活動相關，包括臨床試驗材料的製造成本。這一增長也反映了我們在今年早些時候積累的更高的人員和諮詢成本。

General administrative expenses were $5 million for 2022 as compared to $3.6 million in 2021 with the increases associated with higher personnel, consulting, and patent processes. So overall net loss for 2022 was $14 million or $0.83 per share, versus $18.6 million in 2021 or $3.4 per share. Again, the increases during 2022 are primarily associated with ramp up organizational infrastructure and other costs associated with the CM04S1 and Gedeptin clinical trials.

2022 年的一般管理費用為 500 萬美元，而 2021 年為 360 萬美元，增加的人員、諮詢和專利流程增加。因此，2022 年的總體淨虧損為 1400 萬美元或每股 0.83 美元，而 2021 年為 1860 萬美元或每股 3.4 美元。同樣，2022 年期間的增長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 December 31 were approximately $27.6 million as compared to $11.4 million at the end of '21. The change in our cash balances for 22 was reflective of $19 million used in operating activities offset by proceeds from stock offerings in January and May, with combined net proceeds to us of nearly $28 million, and an additional $7.6 million in proceeds from the (inaudible) warrants during third quarter of last year. Our outstanding common shares now stand at $26.3 million.

現在轉向資產負債表。我們在 12 月 31 日的現金餘額約為 2760 萬美元，而 2021 年底為 1140 萬美元。我們 22 年現金餘額的變化反映了用於經營活動的 1900 萬美元被 1 月和 5 月的股票發行收益所抵消，我們的淨收益合計近 2800 萬美元，另外還有 760 萬美元的收益（聽不清) 去年第三季度的認股權證。我們流通在外的普通股現在為 2630 萬美元。

In summary, we are well positioned to accelerate and advance our clinical programs with a cash runway sufficient to fund our operations and priority programs to the end of 2023. Funding our three ongoing Phase 2 clinical programs and preparing for the next stages of development are the most significant use of our cash and our top financial priority. I'll be happy to answer any questions during the Q&A, and I will now turn call back over to David.

總之，我們有能力加速和推進我們的臨床項目，現金跑道足以為我們的運營和優先項目提供資金，直至 2023 年底。為我們正在進行的三個 2 期臨床項目提供資金並為下一階段的開發做準備是最重要的現金使用和我們的首要財務優先事項。我很樂意在問答環節回答任何問題，現在我會把電話轉給大衛。

Thank you, Mark. My colleagues and I will now answer your questions. Joining us for the Q&A session are Dr. Mark Newman, Dr. Kelly McKee, Dr. John Sharkey, our Chief Scientific Officer, Chief Medical Officer and Vice President 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、John Sharkey 博士，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 over to the operator for instructions on the question and answer period.

我現在將電話轉給接線員，以獲取有關問答時間的說明。

Thank you. And before we take questions, I'm going to hand the floor to Mark Reynolds for some comments. Thank you.

謝謝。在我們提問之前，我要請 Mark Reynolds 發表一些意見。謝謝。

Take a minute to tell all the listeners that what you just heard was prerecorded by David in May. Unfortunately, David had an unexpected family emergency today and he is going to be unavailable to participate in a live Q&A session. But I still have with me today, Mark Newman, John Sharkey, and Kelly McKee, and we'll all do our best to answer any questions that might arise. So I'll turn it back to the operator now.

花點時間告訴所有的聽眾，你們剛才聽到的是大衛在五月份預先錄製的。不幸的是，大衛今天遇到了意外的家庭緊急情況，他將無法參加現場問答環節。但今天我還有馬克紐曼、約翰夏基和凱利麥基，我們都會盡力回答可能出現的任何問題。所以我現在把它轉回給接線員。

Thank you. And at this time, we will begin our question and answer session. (Operator Instructions)

謝謝。此時，我們將開始問答環節。 （操作員說明）

Jason Kolbert, Dawson James.

傑森科爾伯特，道森詹姆斯。

Hi guys. Congratulations on all the progress. A couple of questions across a couple of areas. First on Gedeptin. At what point do you think you hit a proof of concept? That's what I'm trying to understand. Phase 1/2 trial? At what point do you walk away and say, yes, this thing works.

嗨，大家好。祝賀所有的進步。幾個領域的幾個問題。首先是 Gedeptin。你認為你在什麼時候達到了概念驗證？這就是我想要理解的。 1/2 期試驗？你什麼時候走開說，是的，這東西有用。

Mark or Kelly, which one would you take that question, please?

Mark 或 Kelly，請問您會選擇哪一位？

Well, this is Kelly. Let me let me sort of start off. That's really kind of a hard question to answer. We have proof of concept in a general sense from the Phase 1 study that is already completed. In that we demonstrated that injection of tumors with Gedeptin followed by fludarabine infusions shrank the tumors. Now this is palliative therapy. So we have no expectation that we're going to improve overall survival or even necessarily link the survival. But we do have proof of concept already that this technology will shrink tumors.

嗯，這是凱利。讓我開始吧。這真是一個很難回答的問題。我們從已經完成的第一階段研究中獲得了一般意義上的概念證明。在這一點上，我們證明了用 Gedeptin 注射腫瘤然後輸注氟達拉濱可以縮小腫瘤。現在這是姑息療法。所以我們不期望我們會提高整體生存率，甚至不一定將生存率聯繫起來。但我們確實已經有了這項技術將縮小腫瘤的概念證明。

The current study is designed to sort of follow up that initial trial by giving repeat administrations of Gedeptin and repeat with fludarabine infusions following to activate the protein inside the tumor. And sort of assess not only sort of what the safety profile is with repeat administration, but to see whether we're seeing an accelerated benefit or an expanded benefit in shrinking tumors. And we've -- it's a small number of patients. We've now enrolled 8 of our target 10. And once that stage is completed and we start looking at all the data sort of qualitatively as well as quantitatively, I think we'll have a better sense for that. And that information should start to become available towards the end of the summer given sort of the timelines of the trial itself. Does that help answer your question?

目前的研究旨在通過重複給予 Gedeptin 並在激活腫瘤內的蛋白質後重複輸注氟達拉濱來對初始試驗進行排序。不僅要評估重複給藥的安全性，還要看我們是否看到了縮小腫瘤的加速效益或擴大效益。而且我們 - 這是少數患者。我們現在已經招募了 10 名目標中的 8 名。一旦該階段完成，我們開始從定性和定量的角度研究所有數據，我認為我們將對此有更好的認識。考慮到試驗本身的時間表，這些信息應該會在夏末開始提供。這有助於回答您的問題嗎？

Yes, no, that does. It establishes the timeline, we're going to get a peek at any point in time and see what the data looks like. What's the best case scenario that you'd like to see?

是的，不，確實如此。它建立了時間線，我們將隨時查看任何時間點並查看數據的樣子。您希望看到的最佳案例是什麼？

The best case is we take our data package to the FDA and they they look at it and tell us well, you know, if you can give us similar data in additional reasonable number of patients -- so we don't know what that reasonable number would be. We were initially hoping it would be somewhere in the neighborhood of 20 to 40, but it's probably going to be more than that. But then we could achieve an accelerated approval for this as an unmet medical need.

最好的情況是我們將我們的數據包帶到 FDA，他們看了之後告訴我們，如果你能給我們更多合理數量的患者的類似數據——所以我們不知道什麼是合理的數將是。我們最初希望它會在 20 到 40 附近的某個地方，但它可能會更多。但隨後我們可以將此作為未滿足的醫療需求獲得加速批准。

But again, it sort of depends on what the data looks like when we finish the trial, and what the environment at the FDA is in terms of accelerated approvals for these kinds of therapies at the time that we presented to them.

但同樣，這在某種程度上取決於我們完成試驗時數據的樣子，以及 FDA 在我們向他們展示時加速批准這些療法的環境。

Okay. Fair enough. Understood. Similar question on the COV-2 vaccine program. Two Phase, two trials. What's the next focal point that we should be looking at in terms of that dataset?

好的。很公平。明白了。關於 COV-2 疫苗計劃的類似問題。兩個階段，兩個試驗。就該數據集而言，我們應該關注的下一個焦點是什麼？

Well, so the two trials that we have ongoing, one of them is in healthy volunteers as healthy individuals as a heterologous booster. And we're about between a third and a halfway through enrollment. With the addition of our new clinical site, we anticipate accelerating enrollment dramatically, and hope to have that study fully enrolled within the next couple or three months at worst. And given the follow-up that can -- the primary endpoint, it's a primary immune marker endpoint is a month or so after the booster. So we should start seeing some of that data hopefully by three quarter -- well, say early quarter four of this year.

那麼，我們正在進行的兩項試驗，其中一項是在健康志願者中作為異源助推器作為健康個體。我們大約進行了三分之一到一半的註冊。隨著我們新的臨床站點的增加，我們預計會大大加快入組速度，並希望在接下來的幾個月或最壞的情況下讓該研究完全入組。考慮到可以進行的後續行動——主要終點，它是主要免疫標記終點是加強後一個月左右。因此，我們應該希望在三季度之前開始看到其中的一些數據——好吧，比如說今年四季度初。

The study that we've got ongoing in patients with hematologic malignancies is a much slower pace study. We've not been able to enroll that study as quickly as we had anticipated at the City of Hope, National Medical Center where it was begun. And for that reason, we've begun enlisting support of multiple other academic medical centers. And by summertime, we should have a handful of those lined up and enrolling patients. So I wouldn't anticipate any significant readouts of that for -- best guess, a year or something like that. (multiple speakers) It's hard to find patients that meet the eligibility criteria for this trial.

我們在血液系統惡性腫瘤患者中正在進行的研究是一項進展緩慢的研究。我們無法像我們在國家醫療中心國家醫療中心希望之城開始的那樣迅速招募該研究。出於這個原因，我們已經開始爭取其他多個學術醫療中心的支持。到夏季，我們應該有一些排隊並招募患者的人。所以我預計不會有任何重要的讀數 - 最好的猜測，一年或類似的時間。 （多位發言者）很難找到符合該試驗資格標準的患者。

Okay. Fair enough. And my last question is really understanding the importance of the NDA manufacturing process. What I'm thinking here is that what you're saying is in the event that there is another pandemic, the ability to be able to make a vaccine at scale, high capacity, high yield quickly becomes critical. Obviously, you're differentiated from an mRNA process, which is a pretty rapid process too. But you're making the point that you're getting a way. Egg based vaccine technology is something in the past. And you've now kind of got this critical piece in place. Is that is that understanding correct or perhaps you would add to that?

好的。很公平。我的最後一個問題是真正理解 NDA 製造過程的重要性。我在這裡想的是，你所說的是，如果發生另一場大流行，能夠大規模、高容量、高產量地迅速生產疫苗的能力變得至關重要。顯然，你與 mRNA 過程不同，後者也是一個非常快速的過程。但是您要指出的是您正在找到一種方法。基於雞蛋的疫苗技術已經成為過去。你現在已經準備好這個關鍵部分了。這種理解是正確的，還是您可以補充一下？

Mark Newman, let me comment on that one. Sure. Yes, that is the goal here. The mRNA is a platform as you mentioned, really enables you to do a rapid response. So there's a difference we've seen a response and building of vaccine capabilities. So the cell line production gives us a large scale. But it's also the idea is to get back to kind of the normal world of vaccines where childhood vaccines are given at a young age and you hope never to get never to get sick rest of your life type of thing. And that's what we're looking at for our products.

馬克紐曼，讓我評論一下。當然。是的，這就是這裡的目標。 mRNA 是你提到的一個平台，真的可以讓你做出快速反應。因此，我們看到了反應和疫苗能力建設的不同。所以細胞系生產給了我們很大的規模。但它的想法也是回到正常的疫苗世界，在這種情況下，兒童疫苗是在年輕時接種的，你希望永遠不會生病，永遠不會生病。這就是我們正在尋找的產品。

So larger scale manufacturing needed to meet that type of distribution. So it's -- we're focused on COVID. So you can always being compared to the mRNA vaccine groups, but we're actually targeting that field totally differently. So that's the issue. It's kind of -- we can [build] small scale and certainly address with the current technology smaller niche types of patient populations. But to really expand it, which is what is in our plans, that will fit into the cell production based system.

因此，更大規模的製造需要滿足這種類型的分銷。所以它是——我們專注於 COVID。所以你總是可以與 mRNA 疫苗組進行比較，但我們實際上針對的是完全不同的領域。這就是問題所在。這有點——我們可以 [建立] 小規模，當然可以用當前的技術解決較小的利基類型的患者群體。但要真正擴展它，這就是我們的計劃，它將適合基於細胞生產的系統。

Yes, thank you. That really clear clears that up for me a lot. Congratulations on all the progress. I hope David is well. Thank you.

是的，謝謝。這真的很清楚，對我來說很清楚。祝賀所有的進步。我希望大衛一切安好。謝謝。

Vernon Bernardino, H.C. Wainwright.

弗農貝納迪諾，H.C.溫賴特。

Hi. Thanks for taking my questions. Most of them have already been asked and answered. But just wanted to follow up on Jason's question regarding Gedeptin. And that's the kind of efficacy that we might expect from the Phase 1/2. You mentioned that 8 patients have been enrolled. And perhaps expect some data at the end of summer. But what kind of data would that be? Would that be just data in which you confirm that Gedeptin shrinks tumors or is there some other kind of efficacy data you expect to announce?

你好。感謝您回答我的問題。他們中的大多數已經被詢問和回答。但只是想跟進 Jason 關於 Gedeptin 的問題。這就是我們對第 1/2 階段的預期效果。你提到已經招募了 8 名患者。也許可以期待夏末的一些數據。但是那會是什麼樣的數據呢？那隻是您確認 Gedeptin 縮小腫瘤的數據，還是您希望公佈其他類型的療效數據？

Well, we are measuring our endpoint measures include two -- We graded these these tumors under RECIST 1.1. And we will be taking tumor measurements. We'll be looking at not only the sort of quantitative impact on injected tumors, but the potential effect on distant tumors that were not injected. And it's as much to give us a sense for -- or some confidence in that what we're doing is actually benefiting patients in a meaningful way just in terms of improving somewhat their quality of life. But also sort of giving us some guidance with regard to direction for follow-on studies.

好吧，我們正在衡量我們的終點指標包括兩個——我們根據 RECIST 1.1 對這些腫瘤進行了分級。我們將進行腫瘤測量。我們不僅要研究對注射腫瘤的定量影響，還要研究對未註射的遠處腫瘤的潛在影響。這同樣讓我們感覺到——或者讓我們相信我們正在做的事情實際上是以一種有意義的方式使患者受益，只是在一定程度上改善了他們的生活質量。但也為我們提供了一些關於後續研究方向的指導。

There's no doubt that we're going to have to add additional patients to the 10 that we will have at the end of this trial. But whether that means we will be able to, for example, increase the amount of fludarabine we're able to give patients to give a chance to activate more of the Gedeptin inside the tumor, tumor masses that are injected, whether that means we can and either dial up or dial back the amount of injected and the virus that carries the activating protein into the tumors. Those kinds of questions, we'll get some sense for where we can take this study as we go into additional patients.

毫無疑問，我們將不得不在試驗結束時增加 10 名患者。但這是否意味著我們能夠，例如，增加我們能夠為患者提供的氟達拉濱的量，從而有機會激活更多腫瘤內的 Gedeptin，注射的腫瘤塊，這是否意味著我們可以並調高或調低注射量和攜帶激活蛋白進入腫瘤的病毒。這些問題，當我們進入更多患者時，我們將了解我們可以在哪裡進行這項研究。

Does that help you?

這對你有幫助嗎？

Yes.

是的。

And a follow up and do you have any expectations on how many repeat cycles it may be possible, especially when you're also getting fludarabine?

然後跟進，您對可能的重複週期有多少期望，尤其是當您還服用氟達拉濱時？

Well. So each cycle right now involves injection of Gedeptin -- three Gedeptin injections over a two-day period, followed by three days of fludarabine. Now -- and it's five cycles for each -- up to five cycles for each patient. Now whether we can add additional cycles -- whether additional cycles would be useful, we really don't know that yet. And again, these are questions that we want to explore as we progress the development program. But we don't have enough information now to be able to make that decision.

出色地。所以現在每個週期都涉及注射 Gedeptin——在兩天內註射 3 次 Gedeptin，然後是三天的氟達拉濱。現在 - 每個患者五個週期 - 每個患者最多五個週期。現在我們是否可以添加額外的循環——額外的循環是否有用，我們真的還不知道。同樣，這些是我們在推進開發計劃時想要探索的問題。但是我們現在沒有足夠的信息來做出那個決定。

And you expect to discuss on data from the 10 patients with the FDA? And what do you think that'll be this year?

您希望與 FDA 討論這 10 名患者的數據？你認為今年會是什麼？

Yes, I mean, we are obviously sort of constrained by how quickly we can enroll these final two patients. And then, if you sort of follow -- if these final two patients follow the entire five cycle program, we're looking at basically six months from the time that the last patient is enrolled. So give us a month or so to analyze the data and pull it together, schedule meeting with the FDA. So we're hoping we'll be able to get in front of them by the end of the year. But there are some factors that are sort of beyond our control in that regard.

是的，我的意思是，我們顯然在某種程度上受到了我們招募最後兩名患者的速度的限制。然後，如果你有點遵循——如果這最後兩名患者遵循整個五個週期的計劃，我們基本上會看到從最後一名患者登記後的六個月。所以給我們一個月左右的時間來分析數據並將其整合在一起，安排與 FDA 的會議。所以我們希望我們能夠在今年年底前趕上他們。但是在這方面有些因素是我們無法控制的。

Terrific. That's very helpful. And thanks for taking my questions.

了不起。這很有幫助。感謝您回答我的問題。

Jason McCarthy, Maxim Group.

馬克西姆集團的傑森麥卡錫。

Hi, this is Joanne Lee on the call for Jason McCarthy. Thanks for taking the question. Just two from me as most of my questions have already been answered. But firstly, I guess sort of from a broader perspective, do you guys have any numbers on the proportion of patients who are getting regular boosting and revaccination? And would you expect this to be sort of the addressable population for your vaccine? Curious to hear your thoughts.

嗨，我是喬安妮·李，正在接聽傑森·麥卡錫的電話。感謝您提出問題。我只有兩個，因為我的大部分問題都已經得到解答。但首先，我想從更廣泛的角度來看，你們有沒有關於定期加強免疫和重新接種疫苗的患者比例的數字？您是否希望這成為您疫苗的可尋址人群？很想听聽你的想法。

When you mean patients, you mean you mean our hematologic malignancy population or who are you talking about specifically?

當您指的是患者時，您指的是我們的血液惡性腫瘤人群，或者您具體指的是誰？

For the COVID. Related to the COVID vaccine, I guess. How many people are up-to-date and actively getting boosters. And I guess if your COVID vaccine that you're currently developing would be addressable to this population of patients?

對於 COVID。我猜與 COVID 疫苗有關。有多少人是最新的並積極獲得助推器。我想您目前正在開發的 COVID 疫苗是否適用於這部分患者？

Well, I mean, I would anticipate that given the impact that this disease can have on immunocompromised populations of patients, virtually all of them will be getting regular boosters with mRNA vaccines according to the schedule prescribed by the CDC and the cancer societies. But we don't have any specific numbers in hand. What we do know is that the response that these patients generate to mRNA vaccines is suboptimal compared to that seen in normal healthy individuals. And that they remain vulnerable to contracting severe illness when they get infected with this virus.

嗯，我的意思是，我預計鑑於這種疾病可能對免疫功能低下的患者群體產生的影響，幾乎所有患者都將根據 CDC 和癌症協會規定的時間表定期接種 mRNA 疫苗加強劑。但我們手頭沒有任何具體數字。我們所知道的是，與正常健康個體相比，這些患者對 mRNA 疫苗產生的反應是次優的。而且當他們感染這種病毒時，他們仍然容易患上嚴重的疾病。

Great. Appreciate the color. And moving on, I guess, to the head and neck cancer trial. How long do you think the trial will go in terms of enrollment? And what kind of response rate do you think would be clinically meaningful to advanced the program?

偉大的。欣賞顏色。我想，然後繼續進行頭頸癌試驗。您認為試驗將在註冊方面進行多長時間？您認為什麼樣的反應率對推進該計劃具有臨床意義？

You've just asked the two questions that we're going to be curious to hear from the FDA about on. We don't really know right now what they're going to require in order for us to be granted an accelerated approval. We have some estimates from some of our consultants that range anywhere from 80 to 120 patients. But whether that's really what they're thinking right now, we don't know.

您剛剛問了我們很想從 FDA 那裡聽到的兩個問題。我們現在真的不知道他們需要什麼才能讓我們獲得加速批准。我們從我們的一些顧問那裡得到一些估計，範圍從 80 到 120 名患者不等。但他們現在是否真的這麼想，我們不知道。

And in terms of what sort of the endpoints, what sort of readouts. Again, we don't know what the emphasis is going to be. Whether it's going to be sort of tumor response in terms of shrinkage, whether it's going to be a quality of life measure, some combination of that. We really don't know what they're going to require. And between now and our meeting with the FDA, we're going to solicit input from a number of regulatory specialists that have been working in this area to give us some thoughts and recommendations about what to present, what to propose.

就什麼樣的端點而言，什麼樣的讀數。同樣，我們不知道重點是什麼。它是否會在縮小方面成為某種腫瘤反應，是否會成為一種生活質量衡量標準，這些的某種組合。我們真的不知道他們需要什麼。從現在到我們與 FDA 的會議，我們將徵求一些一直在該領域工作的監管專家的意見，以便為我們提供一些想法和建議，說明要展示什麼，要提出什麼建議。

Got it. Appreciate you taking all the time to provide updates. Congrats again on the quarter.

知道了。感謝您抽出寶貴時間提供更新。再次祝賀本季度。

Robert LeBoyer, NOBLE Capital Markets.

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

Good afternoon. I was hoping that you could discuss some of the things in the Gedeptin trial, and specifically the use of the checkpoint inhibitors that was mentioned earlier. There was a mention of the dosing regimen. But I was curious as to whether you are going to have separate arms with checkpoint inhibitors or all patients? Or how are you going to go about testing it, either (inaudible) either alone or in combination?

下午好。我希望你能討論 Gedeptin 試驗中的一些事情，特別是前面提到的檢查點抑製劑的使用。提到了給藥方案。但我很好奇，你們是要分別使用檢查點抑製劑還是所有患者？或者您將如何單獨或組合（聽不清）進行測試？

Yes. So well, I mean, fundamentally, we don't have a study design specifically in mind at this point in time. However, we recognize the potential that adding a checkpoint inhibitor offers to a therapy like Gedeptin. I mean, there's sort of biologically plausible rationale for doing this. And there are other therapeutic agents in trials in head and neck cancer that are sort of capitalizing on this concept at the present time. So we have some ideas about how to go about doing this. But we don't have any specific design in mind at this time.

是的。好吧，我的意思是，從根本上說，我們此時並沒有專門考慮研究設計。然而，我們認識到添加檢查點抑製劑為 Gedeptin 等療法提供的潛力。我的意思是，這樣做有某種生物學上合理的理由。目前，在頭頸癌的試驗中還有其他治療藥物正在利用這一概念。所以我們對如何著手做這件事有一些想法。但我們目前沒有任何具體的設計想法。

The preclinical work that's ongoing is with our collaborators at Emory University in which they've demonstrated in animal models some very encouraging results which I think are going to support moving forward and how to move forward. Our thinking at this time, and this is not meant to commit us in a way. But our thinking at this time is that offering Gedeptin as a checkpoint in the context of neoadjuvant therapy is a very appealing approach. And we intend to explore that extensively as we discussed, taking the program down the road in multiple different directions.

正在進行的臨床前工作是與我們在埃默里大學的合作者進行的，他們在動物模型中展示了一些非常令人鼓舞的結果，我認為這些結果將支持前進以及如何前進。我們此時的想法，這並不意味著要以某種方式承諾我們。但我們目前的想法是，在新輔助治療的背景下提供 Gedeptin 作為檢查點是一種非常有吸引力的方法。我們打算像我們討論的那樣廣泛地探索這一點，讓這個項目朝著多個不同的方向發展。

Okay. Thank you very much.

好的。非常感謝。

Thank you. (Operator Instructions)

謝謝。 （操作員說明）

Kumar Raja, ROTH Capital.

羅斯資本的 Kumar Raja。

Thanks for taking my questions. So first one, with regard to the MUC1 IND filing, what needs to be done there before -- and also the timing? And with regard to the Gedeptin trail, what are you seeing in terms of the screen failure rate, and what should we expect in terms data at ASCO?

感謝您回答我的問題。那麼第一個，關於 MUC1 IND 備案，之前需要在那裡做什麼——還有時間安排？關於 Gedeptin 試驗，您在篩選失敗率方面看到了什麼，我們在 ASCO 的數據方面應該期待什麼？

I'll take the Gedeptin one and then Mark and Mark will address the MUC1 question. So we're not presenting anything at ASCO. I'm going to be going to that meeting and availing myself the opportunity to interact with many of the key opinion leaders in the head-and-neck cancer field to pick their brains to see sort of see what the state of the art is with using some sort of therapeutic interventions, either alone or in conjunction with checkpoint inhibitors and other immunologic sort of -- I don't want to say adjuvants, but in combination with other immunologic stimulators -- stimulants.

我將使用 Gedeptin，然後 Mark 和 Mark 將解決 MUC1 問題。所以我們不會在 ASCO 上展示任何東西。我將要去參加那次會議，並藉此機會與頭頸癌領域的許多主要意見領袖互動，徵求他們的意見，看看最先進的技術是什麼使用某種治療干預措施，單獨使用或與檢查點抑製劑和其他免疫學類型——我不想說佐劑，但與其他免疫刺激劑——興奮劑結合使用。

So there's no data that is going to be presented at ASCO because we don't really have a complete dataset to be able to present. What was your other question about Gedeptin before I give it back to Mark?

所以沒有數據會在 ASCO 上展示，因為我們真的沒有完整的數據集可以展示。在我把 Gedeptin 還給 Mark 之前，你還有什麼問題？

I was wondering what you're seeing in terms of screen failure rate.

我想知道您在屏幕故障率方面看到了什麼。

Yes. So that's really a hard question to answer because the patients that are offered to us by our site investigators are those that are sort of at the end of their other therapeutic options. And patients tend to be pretty identified at some point well in advance of the time that they're really ready to enroll in our trial. And whether they start -- whether they show a response to a current therapeutic regimen that they're on or whether they find themselves in such dire straits because of their underlying disease that they don't qualify because of abnormal blood chemistries or cardiac failure or whatever. It's kind of all over the place. And so we don't really see -- the patients aren't screened unless they sort of get to the point where they're in a position where the investigator thinks there's a reasonable chance that they could enroll in our trial. Now once they get to that point, I would guess at our screen failure rate is probably somewhere in the neighborhood of 25% to 50%.

是的。所以這真的是一個很難回答的問題，因為我們現場調查人員提供給我們的患者是那些其他治療選擇已經結束的患者。患者往往會在他們真正準備好參加我們的試驗之前的某個時間點得到很好的識別。以及他們是否開始——他們是否對他們正在接受的當前治療方案有反應，或者他們是否發現自己因為潛在的疾病而陷入如此可怕的困境，以至於他們因血液化學異常或心力衰竭而無法勝任，或者任何。到處都是。因此，我們並沒有真正看到——除非患者達到某種程度，即研究人員認為他們有合理的機會可以參加我們的試驗，否則不會對患者進行篩查。現在一旦他們達到這一點，我猜我們的屏幕故障率可能在 25% 到 50% 左右。

Okay. That's great.

好的。那太棒了。

Thank you.

謝謝。

Jeffrey Kraws, Crystal Research.

杰弗里克勞斯，水晶研究。

Thank you very much. Many of my questions were already asked. But the questions remain, you just addressed ASCO, but you expect to be presenting any scientific papers or scientific presentations or dataset presentations at any of the three scientific conferences you're attending?

非常感謝。我的很多問題都已經被問過了。但問題仍然存在，您剛剛在 ASCO 發表了講話，但您希望在您參加的三個科學會議中的任何一個上發表任何科學論文或科學報告或數據集報告？

For Gedeptin or for?

對於 Gedeptin 還是為了？

For anything.

為了任何東西。

Yes.

是的。

Just not at ASCO. The other two, yes.

只是不在 ASCO。另外兩個，是的。

Right, yes. There's going to be data presented at the World Vaccine Congress in early April. There's going to be data of CM04S1. There is going to be data presented at the Vaccine Summit in Boston. I guess that's early June or maybe late May on CM04S1. And then there's a flow cytometry conference in May for some data. And that's sort of the -- some of the lab -- more technical lab stuff associated with our trial that's going to be presented as well.

對，是的。將在 4 月初的世界疫苗大會上公佈數據。將有 CM04S1 的數據。將在波士頓的疫苗峰會上公佈數據。我想那是 CM04S1 的 6 月初或 5 月下旬。然後在 5 月份召開了一個流式細胞術會議，以獲取一些數據。這就是 - 一些實驗室 - 更多與我們的試驗相關的技術實驗室材料，這些材料也將被展示。

Fantastic. I know you've been working very hard to move that along and that's great news.

極好的。我知道您一直在努力推動這一進程，這是個好消息。

The second question is with regard to the manufacturing and having that as one of your goals. If one was to look at your manufacturing validation that you want to have, and just say you hope to have it by a certain date, what would you say the percentage of working towards that is complete now? I'm not asking you what the specific guide is. You say you're 50% or 60% there, 80% there, just roughly.

第二個問題是關於製造並將其作為您的目標之一。如果要查看您想要獲得的製造驗證，並且只是說您希望在某個日期之前獲得它，那麼您認為現在完成的工作百分比是多少？我不是問你具體的指南是什麼。你說你在那裡有 50% 或 60%，大約有 80%。

Mark, John, that's yours.

馬克，約翰，那是你的。

So we have different viral vector vaccines, right? So we're in the [Ebola] field. We've got 04S1, which is the other COVID -- first step towards a universal COVID vaccine. And you match each of these -- well, we are at least evaluating each of these with different cell lines for expression systems. And that's a stepwise process. So the first thing you want to know is that a particular virus will grow in a particular cell line. And sometimes they don't. Sometimes the insert causes a toxicity. And these cell lines can be duck origin or chicken origin. They're all tumor cell type of lines, but with slightly different genetic variations based on the birds you get them from.

所以我們有不同的病毒載體疫苗，對吧？所以我們在[埃博拉]領域。我們有 04S1，這是另一種 COVID——邁向通用 COVID 疫苗的第一步。你匹配其中的每一個——好吧，我們至少正在用表達系統的不同細胞系評估每一個。這是一個循序漸進的過程。所以你首先要知道的是特定病毒會在特定細胞系中生長。有時他們沒有。有時插入物會引起毒性。這些細胞係可以是鴨源或雞源。它們都是腫瘤細胞類型的細胞系，但根據您從中獲得它們的鳥類，它們的遺傳變異略有不同。

So you march through the series of events and say which cell line supports which virus. Now for 04S1, we've actually got a choice. We've taken that along to the point where we're comfortable, we could make a choice whenever we wanted to. They are produced with different manufacturing technologies, which we -- they're out there. We would just have to select how we wanted to do it. So we're actually at the stage now where we're talking business terms, and that would be John Sharkey. I don't know that we're going to share any details on that. But that one's ready to go on.

所以你通過一系列事件並說出哪個細胞系支持哪種病毒。現在對於 04S1，我們實際上有一個選擇。我們已經把它帶到了我們感到舒服的地步，我們可以隨時做出選擇。它們是用不同的製造技術生產的，我們——它們就在那裡。我們只需要選擇我們想要的方式。所以我們現在實際上正處於討論業務術語的階段，那就是 John Sharkey。我不知道我們是否會分享這方面的任何細節。但是那個人已經準備好繼續了。

We have another candidate. I know another research level product where I think we would know exactly where we would go, but it's still in the mouse model. And it's kind of a secondary approach, more of a universal COVID. But we're not focusing on that as much as the 04S1.

我們還有另一位候選人。我知道另一種研究級產品，我認為我們會確切地知道我們會去哪裡，但它仍然在鼠標模型中。這是一種輔助方法，更像是一種通用的 COVID。但我們並沒有像 04S1 那樣專注於此。

So we're there, but I think you will have to say that each one of these is likely to be a specific paired system. It would be great if we could find a single manufacturer and a single cell line that would do it all for us. And I'm hopeful. Maybe we'll get lucky. But realistically, we have seen variation. And so we're doing the right stuff, each of the steps for each product. So these lead product, we're ready. We can make a decision.

所以我們就在那裡，但我認為你必須說其中的每一個都可能是一個特定的配對系統。如果我們能找到一個製造商和一個細胞係來為我們完成這一切，那就太好了。我充滿希望。也許我們會走運。但實際上，我們已經看到了變化。所以我們正在做正確的事情，每個產品的每個步驟。所以這些主導產品，我們準備好了。我們可以做出決定。

Perfect. (inaudible) concur with what you said.

完美的。 （聽不清）同意你所說的。

One final question is, you're seeing a lot of interest and a lot of movement out there, much pharma companies in our coverage of pharma. We're seeing still a strong interest in partnering with novel companies with unique and differentiated technologies that are game-changers. Are you still seeing a lot of interest from potential partners?

最後一個問題是，你看到了很多興趣和很多動作，很多製藥公司都在我們的製藥報導中。我們看到人們仍然對與擁有改變遊戲規則的獨特和差異化技術的新公司合作有著濃厚的興趣。您是否仍然看到潛在合作夥伴的濃厚興趣？

Yes, I'll take that one. Hey, Jeff, thanks for the question. So actually, I was in (inaudible) earlier this week at the Biospring European partnering meetings. And as you know, we started discussions with companies last year at Bio. And what I can say is that I'm seeing more and more interest in once people understand the niche we're trying to work in. I mean, the reality is, the world's gotten a little tired of COVID in the general population. And so I'm often asked, do we need another COVID vaccine. So when you kind of lay out where we're working in immune-compromised that the current vaccine just are not adequate to protect these people. And the people are risks people are people engage with now.

是的，我會拿那個。嘿，傑夫，謝謝你的提問。所以實際上，本週早些時候我在（聽不清）參加了 Biospring 歐洲合作會議。如您所知，我們去年在 Bio 上開始與公司進行討論。我能說的是，一旦人們了解了我們正在努力工作的利基市場，我就會看到越來越多的興趣。我的意思是，現實情況是，世界對普通民眾中的 COVID 已經有點厭倦了。所以我經常被問到，我們是否需要另一種 COVID 疫苗。因此，當你說出我們在免疫受損的地方工作時，目前的疫苗不足以保護這些人。人就是人們現在參與的風險。

Are we at the point where you say somebody is going to snap it up? I can't say that. But I will say that people are engaging with us and following up with us on stock. And so I think where we're working, we're succeeding convincing people there's a real need in this space. And that's jusy a lot of attractive options in this space. And these are patients who are normally under active treatment or being medically managed or being managed by specialists, which means that smaller field force is detailed them. They're easier to identify and get to. There's a lot of positives from a commercial side and work.

我們是否到了你說有人要搶購它的地步？我不能這麼說。但我會說人們正在與我們接觸並跟進我們的庫存。所以我認為我們正在努力的地方，我們正在成功地說服人們在這個領域有真正的需求。這就是這個領域的許多有吸引力的選擇。這些患者通常正在積極治療或接受醫療管理或由專科醫生管理，這意味著他們需要更小的現場力量。它們更容易識別和到達。商業方面和工作有很多積極因素。

Thanks. Appreciate your candidness. Thanks for taking the questions, keep up the good work.

謝謝。欣賞你的坦率。感謝您提出問題，繼續努力。

Thank you.

謝謝。

Thank you. There are no questions at this time. I'll hand the floor back to Mark Reynolds for closing remarks.

謝謝。目前沒有問題。我會將發言權交還給 Mark Reynolds，讓他發表閉幕詞。

Yes, thank you. I just wanted to conclude the call by thanking everybody for participating. Your interest really is greatly appreciated by all of us. I'll say that our focus for this year for 2023 is on execution on reporting updates and progress for Gedeptin and our CM04S1 clinical programs as well as the other development programs we have underway. And for all of us, it is a great pleasure serving shareholders. I say that truthfully and being part of this team. So with that, I'll conclude and just tell everybody have a good day. Thank you.

是的，謝謝。我只是想通過感謝大家的參與來結束電話會議。我們所有人都非常感謝您的關注。我會說，我們今年 2023 年的重點是執行 Gedeptin 和我們的 CM04S1 臨床項目以及我們正在進行的其他開發項目的報告更新和進展。對於我們所有人來說，為股東服務是一件非常愉快的事情。我說的是實話，並且是這個團隊的一員。因此，我將結束並告訴大家祝大家有美好的一天。謝謝。

Thank you. This concludes today's conference. All parties may disconnect. Have a great day.

謝謝。今天的會議到此結束。各方可能會斷開連接。祝你有美好的一天。