GeoVax Labs Inc (GOVX) 2023 Q2 法說會逐字稿

Good day. My name is Jordan, and I'll be your conference operator today. At this time, I would like to welcome everyone to the GeoVax second quarter earnings conference call. I'll turn the call over to Gabrielle.

再會。我叫喬丹，今天我將擔任你們的會議操作員。現在，我歡迎大家參加 GeoVax 第二季度財報電話會議。我會把電話轉給加布里埃爾。

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，並可能受到不確定性和情況變化的影響。

Actual results may differ materially from those included in these statements due to a variety of factors, including whether GeoVax can develop and manufacture its product candidates with the desired characteristics in a timely manner and such products will be safe for human use. GeoVax's vaccines will effectively prevent targeted infections in humans. GeoVax's product candidates will receive regulatory approvals necessary to be licensed and marketed. GeoVax raises required capital to complete development of its products. There is development of competitive products that may be more effective or easier to use than GeoVax's product. GeoVax will be able to enter into favorable manufacturing and distribution agreements and other factors over which GeoVax has no control.

由於多種因素，實際結果可能與這些聲明中包含的結果存在重大差異，包括 GeoVax 是否能夠及時開發和製造具有所需特性的候選產品，以及此類產品是否可供人類安全使用。 GeoVax 的疫苗將有效預防人類的針對性感染。 GeoVax 的候選產品將獲得許可和銷售所需的監管批准。 GeoVax 籌集了完成其產品開發所需的資金。正在開發可能比 GeoVax 的產品更有效或更容易使用的競爭產品。 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 向美國證券交易委員會提交的文件中，包括 GeoVax 表格 10-K 中作為風險因素列出的信息。

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

現在我很高興向大家介紹 GeoVax 的董事長兼首席執行官 David Dodd。大衛？

Good afternoon and thank you for participating in the GeoVax corporate update call. This year, we've expanded patient enrollment and supported the Gedeptin Phase 2 clinical trial and the two Phase 2 trials for GEO-CM04S1, as well as announcing the initiation of the third Phase 2 clinical program evaluating this next-generation COVID-19 vaccine as a booster among patients with chronic lymphocytic leukemia.

下午好，感謝您參加 GeoVax 公司更新電話會議。今年，我們擴大了患者入組範圍，支持 Gedeptin 2 期臨床試驗和 GEO-CM04S1 的兩項 2 期試驗，並宣布啟動第三個 2 期臨床計劃，評估這種下一代 COVID-19 疫苗作為慢性淋巴細胞白血病患者的加強劑。

We also recently expanded our rights related to CMO4S1 to include Omnicom variants, monkeypox, and smallpox, further differentiating our COVID-19 vaccine. While the clinical development progress in Gedeptin and CMO4S1 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 CMO4S1 相關的權利，包括 Omnicom 變種、猴痘和天花，進一步使我們的 COVID-19 疫苗與眾不同。雖然 Gedeptin 和 CMO4S1 的臨床開發進展仍然是我們的首要任務，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。

During the second quarter, we progressed each of these priority initiatives. Currently, we are funded into 2024 and we anticipate further strengthening our balance sheet as a result of supportive stock activities, business development initiatives, and non-dilutive opportunities related to government and NGO funding.

在第二季度，我們推進了每一項優先舉措。目前，我們的資金到 2024 年為止，由於支持性股票活動、業務發展計劃以及與政府和非政府組織資助相關的非稀釋機會，我們預計將進一步加強我們的資產負債表。

As recently announced, interim data from the current Gedeptin clinical program was presented in July at the American Association for Cancer Research and the American Head & Neck Society joint conference on head and neck cancers. We are pleased and encouraged by the results noting no dose-limiting toxicities or serious adverse events definitely attributable to treatment with impaired growth in targeted lesions observed in the majority of the patients. We anticipate completion of the current clinical program shortly, and we are already planning the next stage of clinical development relative to this promising therapy.

正如最近宣布的，當前 Gedeptin 臨床計劃的中期數據於 7 月在美國癌症研究協會和美國頭頸協會頭頸癌聯合會議上公佈。我們對結果感到高興和鼓舞，該結果表明，在大多數患者中觀察到的目標病變生長受損的治療沒有明顯導致劑量限制性毒性或嚴重不良事件。我們預計當前的臨床計劃很快就會完成，並且我們已經在計劃與這種有前景的療法相關的下一階段的臨床開發。

There are approximately 67,000 new cases of head and neck cancers annually in the US, and approximately 13,000 deaths. 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. Patients suffering from advanced head and neck cancer represent a critical unmet medical need.

美國每年約有 67,000 例新發頭頸癌病例，約 13,000 人死亡。這代表了我們最初的目標患者群體。在世界範圍內，每年約有 900,000 例新發頭頸癌病例，約 400,000 例死亡。患有晚期頭頸癌的患者代表了未滿足的關鍵醫療需求。

We are excited about the outlook and promise of Gedeptin therapy against numerous tumors and cancers. We pursue significant opportunity addressing various tumors as monotherapy as well as the potential of combo therapy, administering Gedeptin in conjunction with other therapies such as immune checkpoint inhibitors.

我們對 Gedeptin 治療多種腫瘤和癌症的前景和前景感到興奮。我們尋求以單一療法解決各種腫瘤的重大機會以及聯合療法的潛力，將吉德普汀與免疫檢查點抑製劑等其他療法結合使用。

We anticipate publication of compelling preclinical evaluation of Gedeptin use in combination with ICIs later this year.

我們預計今年晚些時候將發表 Gedeptin 與 ICI 聯合使用的令人信服的臨床前評估。

Relative to commercialization, we anticipate partnering and collaborations in support of worldwide use, for which business development activities have been initiated. We hold worldwide rights for the use of Gedeptin in all indications.

相對於商業化，我們期望通過合作和協作來支持全球使用，為此已經啟動了業務開發活動。我們擁有在全球範圍內在所有適應症中使用 Gedeptin 的權利。

The vast array of unmet medical needs within oncology represents significant opportunities for GFX to advanced novel approaches addressing various cancer patient needs worldwide. Increasingly, we are participating in various oncology conferences, some of which we expect Gedeptin presentations and with others, Gedeptin partnering discussions.

腫瘤學領域大量未滿足的醫療需求為 GFX 提供了重大機會，可以採用先進的新方法來滿足全球各種癌症患者的需求。我們越來越多地參加各種腫瘤學會議，其中一些會議我們期待 Gedeptin 的演講，而另一些會議則希望 Gedeptin 進行合作討論。

GEO-CMO4S1, our next-generation COVID-19 vaccine, differentiates from the currently authorized COVID-19 vaccines and targeting both the antibody and cellular arms of the immune system focused on providing a more robust and durable protection than the current vaccines.

GEO-CMO4S1 是我們的下一代 COVID-19 疫苗，與目前授權的 COVID-19 疫苗不同，它針對免疫系統的抗體和細胞臂，專注於提供比當前疫苗更強大和持久的保護。

This is critically important in addressing the high risk populations of immune compromised individuals for whom the current vaccines and monoclonal antibody therapies are inadequate. 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.

這對於解決免疫受損個體的高危人群至關重要，目前的疫苗和單克隆抗體療法對其來說是不夠的。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的人群，以及接受免疫抑制治療的人群。

In general, patient groups with ablated immune systems unable to respond adequately to approved mRNA vaccines are at such high risk.

一般來說，免疫系統被削弱、無法對已批准的 mRNA 疫苗做出充分反應的患者群體面臨如此高的風險。

In the US, there are approximately 12 to 15 million immune compromised individuals. Worldwide, there are an estimated 200-plus million. This is a major critical need for next-generation COVID-19 vaccines to support such individuals and we believe the CMO4S1 is the leading next-generation vaccine in clinical developed.

在美國，大約有 12 至 1500 萬免疫受損的人。全球範圍內估計有 2 億多人。這是支持此類個體的下一代 COVID-19 疫苗的主要關鍵需求，我們相信 CMO4S1 是臨床開發中領先的下一代疫苗。

During second quarter, the White House announced Project NextGen, 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 being particularly interested in novel vaccine candidates already in clinical trials.

第二季度，白宮宣布了一項價值50 億美元的Project NextGen 計劃，是“曲速行動”的後續行動，旨在尋求具有更廣度的針對變異的保護和更高的耐用性的COVID-19 疫苗，對已經進入臨床的新型候選疫苗特別感興趣試驗。

We believe the CMO4S1 is a leading example of the desired next-generation COVID-19 vaccine. 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 likely exists due to our focus on high-risk populations unserved by the current COVID-19 vaccines and monoclonal antibody therapies.

我們相信 CMO4S1 是理想的下一代 COVID-19 疫苗的領先例子。我們在國內和國際上都對參與我們的臨床開發項目抱有極大的興趣。我們認為，由於我們重點關注當前 COVID-19 疫苗和單克隆抗體療法無法服務的高危人群，因此可能存在加快監管路徑的機會。

Also, we anticipate partnering and collaborations in support of worldwide commercialization and distribution.

此外，我們期望建立夥伴關係和協作來支持全球商業化和分銷。

Regarding Project NextGen, all we can say at this time is that we're deeply involved in the process and discussions. We hope to provide further updates soon.

關於 NextGen 項目，我們目前只能說，我們正在深入參與該過程和討論。我們希望盡快提供進一步的更新。

For the remainder of 2023, we are focused on accelerating efforts in support of the Gedeptin and CMO4S1 Phase 2 clinical programs, advancing our MVA vaccine specific for mpox and smallpox into development and further advancement of our program focused on improved MVA manufacturing processes.

在 2023 年剩餘時間內，我們的重點是加快支持 Gedeptin 和 CMO4S1 2 期臨床計劃，推進我們針對mpox和天花的 MVA 疫苗的開發，並進一步推進我們專注於改進 MVA 製造工藝的計劃。

We also anticipate opportunities to add additional capital in support of these programs, accelerating the pace of progress and reporting a milestone in (technical difficulty)

我們還預計有機會增加額外資金來支持這些計劃，加快進展速度並報告（技術難度）的里程碑

Now, I'd like 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，我想將演示文稿交給 GeoVax 首席財務官 Mark Reynolds，讓其回顧我們最近的業績和財務狀況。標記？

Thank you, David. So starting with our income statement, I'll focus on the comparative figures for the six month periods of 2023 versus 2022.

謝謝你，大衛。因此，從我們的損益表開始，我將重點關注 2023 年與 2022 年六個月期間的比較數據。

We had no active grants during 2023 so far, so we reported no grant revenues as compared to a small amount in 2022. I'll note however that as David suggested, we are actively seeking additional non-dilutive funding for both our preclinical and clinical development programs, and we expect this may potentially be a very important component of our financing mix in the future.

到目前為止，我們在2023 年沒有主動資助，因此與2022 年的少量資助相比，我們沒有報告資助收入。不過，我要指出的是，正如David 所建議的，我們正在積極為我們的臨床前和臨床尋求額外的非稀釋資金發展計劃，我們預計這可能成為我們未來融資組合的一個非常重要的組成部分。

Research and development expenses were $7.5 million in 2023 versus $2.6 million in 2022 with the increase primarily associated with clinical trial activity for the CMO4S1 and Gedeptin programs, including manufacturing costs for clinical trial materials. The increase is also reflective of higher personnel costs as we brought on two additional executive level employees this year, which added depth to our regulatory and quality control functions.

2023 年的研發費用為 750 萬美元，而 2022 年為 260 萬美元，增長主要與 CMO4S1 和 Gedeptin 項目的臨床試驗活動有關，包括臨床試驗材料的製造成本。這一增長也反映了人員成本的增加，因為我們今年增加了兩名高管級別的員工，這增加了我們的監管和質量控制職能的深度。

General and administrative expenses were $2.9 million in 2023 versus $2.1 million in 2022 with the increase mostly associated with higher personnel, consulting, and patent costs. So overall net loss for the first six months of 2023 was approximately $10 million or $0.38 per share versus $4.7 million in 2022 or $0.47 per share, again, with the increase being driven by the CMO4S1 and Gedeptin clinical trial activity.

2023 年一般和管理費用為 290 萬美元，而 2022 年為 210 萬美元，增長主要與人員、諮詢和專利成本增加有關。因此，2023 年前六個月的總體淨虧損約為1000 萬美元，即每股0.38 美元，而2022 年為470 萬美元，即每股0.47 美元，這一增長是由CMO4S1 和Gedeptin 臨床試驗活動推動的。

Turning now to the balance sheet, our cash balance as of June 30 were approximately $18 million as compared to $27.6 million at the end of '22. The change in the cash balances is reflective of $9.8 million used in operating activities. There were no significant financing or investing activities so far during 2023. Our outstanding common shares stand at 26.4 million.

現在轉向資產負債表，截至 6 月 30 日，我們的現金餘額約為 1800 萬美元，而 2022 年底為 2760 萬美元。現金餘額的變化反映了經營活動中使用的 980 萬美元。 2023 年迄今為止，沒有重大融資或投資活動。我們的已發行普通股為 2640 萬股。

Funding our four ongoing Phase 2 clinical programs is the most significant use of our cash and our top financial priority. But I'll note that the recently initiated fourth trial, that being for CLO, is being fully funded primarily through non-dilutive sources with GeoVax providing some relatively minor support for analytical costs. Our cash runway is sufficient to fund these programs through the milestones expected to occur through the end of this year and into early 2024.

為我們正在進行的四個二期臨床項目提供資金是我們現金最重要的用途，也是我們的首要財務優先事項。但我要指出的是，最近啟動的第四項試驗（針對 CLO）主要通過非稀釋性來源全額資助，GeoVax 為分析成本提供了一些相對較小的支持。我們的現金跑道足以為這些項目提供資金，以實現預計在今年年底和 2024 年初實現的里程碑。

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

因此，我很樂意在問答期間回答任何問題。我現在將把電話轉回給大衛。

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

謝謝你，馬克。現在我和我的同事回答大家的問題。參加問答環節的有 Mark Newman 醫生、Kelly McKee 醫生和 John Sharkey 醫生，他們分別是我們的首席科學官、首席醫療官和業務開發副總裁。

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

我現在將把電話轉給接線員，以獲取有關問答階段的說明。

(Operator Instructions) Robert LeBoyer, Noble Capital Markets.

（操作員說明）Robert LeBoyer，Noble Capital Markets。

Hi, and congratulations on all the progress that you've made in the past quarter. My question has to do with your mention of a combination trial with the checkpoint inhibitors, and I was wondering if there was any data that was going to be presented or any plans for the rest of the year? You had mentioned expansion of the current trials and completing enrollment, but I was wondering if there was any intention to start another arm or what the potential for combination therapy is right now?

您好，祝賀您在上個季度取得的所有進展。我的問題與您提到的檢查點抑製劑聯合試驗有關，我想知道今年剩餘時間是否有任何數據或計劃？您提到了擴大當前試驗並完成入組，但我想知道是否有意開始另一組或現在聯合治療的潛力是什麼？

Sure, Robert. This is David. I'll answer and then Kelly, if you want to add anything else.

當然，羅伯特。這是大衛。如果您還想補充什麼，我會回答，然後是凱利。

What I would say is, right now it's in preclinical work, we're supporting that work of the evaluation of Gedeptin in conjunction with ICIs. There is a manuscript that's in development. Again, this is preclinical work that we anticipate that manuscript will be published yet -- that our guidance and understanding is yet this year. And we'll continue to evaluate it. But at this time, we're not working in the clinic in any combo therapy. We're focused right now on the current clinical program.

我想說的是，現在處於臨床前工作中，我們正在支持 Gedeptin 與 ICI 結合的評估工作。有一份手稿正在開發中。同樣，這是臨床前工作，我們預計手稿將在今年發表——我們的指導和理解仍在今年。我們將繼續評估它。但目前，我們還沒有在診所進行任何組合療法。我們現在專注於當前的臨床計劃。

Kelly, do you want to add anything to that?

凱利，你想補充什麼嗎？

Sure. One of the really exciting things about Gedeptin is that its mechanism of action is essentially tumor agnostic with respect to solid cancers, solid tumor cancers. And so I think we have an opportunity to sort of survey the cancer landscape, if you will, and target a number of different tumor types.

當然。 Gedeptin 真正令人興奮的事情之一是，其作用機製本質上與實體癌、實體瘤癌症無關。因此，我認為我們有機會對癌症形勢進行某種調查，如果你願意的話，並針對一些不同的腫瘤類型。

And in that regard, we are exploring next steps in the head and neck cancer space, but we're also in discussions with some academic investigators who have expressed an interest in looking at Gedeptin in breast cancer patients.

在這方面，我們正在探索頭頸癌領域的下一步，但我們也在與一些學術研究人員進行討論，他們表示有興趣在乳腺癌患者中研究 Gedeptin。

And if we proceed in that direction, I think, the likely opportunity will be for us to go in with a combination Gedeptin checkpoint inhibitor trial, the design of which is, again, sort of in early phases of discussion. So really can't go into details on that. But that's probably going to be our next non-[agent] head and neck cancer target.

我認為，如果我們朝著這個方向前進，我們可能有機會進行 Gedeptin 檢查點抑製劑組合試驗，其設計再次處於討論的早期階段。所以真的不能詳細說明這一點。但這可能將成為我們的下一個非[代理]頭頸癌目標。

Kumar Raja, ROTH Capital.

庫馬爾·拉賈（Kumar Raja），羅斯資本。

So I had a question about the booster trial. In terms of data, when can we expect data from this trial? Will we have any interim data from this trial?

所以我對加強試驗有疑問。就數據而言，我們什麼時候可以期待這次試驗的數據？我們會得到這次試驗的任何中期數據嗎？

Kumar, are you asking about the healthy volunteer booster or the booster for the CLL patients?

Kumar，您是在問健康志願者加強劑還是 CLL 患者加強劑？

I'm asking about the CLL trial.

我問的是 CLL 試驗的情況。

Okay. Kelly, you want to address that, please?

好的。凱利，你想解決這個問題嗎？

Yeah. So the CLL trial just began enrolling a couple of weeks ago, and so it's still in the early phases of study. The expectation based on our discussions with the principal investigator at the City of Hope Medical Center and their team is that we'll have that trial fully enrolled within about a six-month period.

是的。 CLL 試驗幾週前才開始招募，因此仍處於研究的早期階段。根據我們與希望之城醫療中心的首席研究員及其團隊的討論，我們預計我們將在大約六個月的時間內完成該試驗的全部入組。

Now, the primary readout is a month or so after the second vaccination, which is three months after the first vaccination. So you do the math and I think you're likely to see at least an initial view of outcomes -- of immunologic outcomes and safety outcomes sometime towards the end of 2024, early 2025. The study itself is a follow up period of a year, so it won't be completed for 6 -- 12 months after it's fully enrolled, so whenever that timepoint hits.

現在，主要讀數是在第二次疫苗接種後一個月左右，即第一次疫苗接種後三個月。所以你算一下，我認為你可能會在 2024 年底、2025 年初的某個時候至少看到結果的初步看法——免疫學結果和安全性結果。這項研究本身是一年的後續階段，因此在完全註冊後的6 - 12 個月內不會完成，因此每當該時間點到來時。

Does that answer your question?

這是否回答你的問題？

Yeah. What I'm trying to get into is like, will you be waiting for all these 80 patients to be enrolled? Or will you be releasing some data out, let us say, data from like 40 patients or something like that? Will you be providing us any update in the interim?

是的。我想問的是，您會等待所有這 80 名患者入組嗎？或者你會發布一些數據，比如 40 名患者的數據或類似的數據？在此期間您會​​向我們提供任何更新嗎？

Well, again, remember this is an investigator-initiated study, and so the operational control of this trial is under the investigator himself. And we are fully informed of progress as the trial proceeds, but as to when specific data will be forthcoming, I can't answer that at this time.

好吧，再次記住，這是一項由研究者發起的研究，因此該試驗的操作控制權由研究者本人負責。隨著試驗的進行，我們已經充分了解了進展情況，但具體數據何時公佈，我目前無法回答。

Okay. And with regard to this manuscript you are preparing with the checkpoint inhibitor, what kind of preclinical models are being used there? And also, is the expectation like, how Gedeptin will be sequenced with the checkpoint? First you'll use Gedeptin and then followed by the checkpoint inhibitor?

好的。關於您正在用檢查點抑製劑準備的這篇手稿，那裡使用了什麼樣的臨床前模型？另外，預期的情況是，Gedeptin 將如何與檢查點進行測序？首先使用 Gedeptin，然後使用檢查點抑製劑？

Well, so the manuscript is being prepared by our academic collaborators and this is based on their work in a mouse model, a mouse tumor model. And the specific details of that I'm not at liberty to disclose, but it will guide the design of our clinical trial. I think you can -- we can say that with some confidence.

那麼，這份手稿是由我們的學術合作者準備的，這是基於他們在小鼠模型、小鼠腫瘤模型中的工作。具體細節我不能透露，但它將指導我們臨床試驗的設計。我認為你可以——我們可以充滿信心地說。

Okay. And mostly this data will be in head and neck cancer models as well as breast cancer models. That's my understanding, is that accurate?

好的。這些數據主要來自頭頸癌模型以及乳腺癌模型。這是我的理解，準確嗎？

I'm not sure. I haven't seen the draft manuscript, so I'm not sure exactly what is being put in there. But I do know that they have data from at least breast cancer -- a breast cancer tumor model and additional tumors. But I'm not sure what additional tumors those are.

我不知道。我還沒有看過手稿，所以我不確定裡面到底寫了什麼。但我確實知道他們至少有乳腺癌的數據——乳腺癌腫瘤模型和其他腫瘤。但我不確定這些是什麼額外的腫瘤。

John Sharkey, do you have that information?

約翰·夏基，你有這些信息嗎？

Yeah. Hey, Kumar. They -- my understanding is they've looked at a couple of different tumor types. They've looked at a glioblastoma. As Kelly said, they've looked at a breast cancer, which ones they're going to include in this publication we're just not aware, privy to until we see the first draft of this. They're in preparation and internal circulation within their institution at the current time.

是的。嘿，庫馬爾。他們——我的理解是他們研究了幾種不同的腫瘤類型。他們研究了膠質母細胞瘤。正如凱利所說，他們已經研究了乳腺癌，他們將把哪些乳腺癌納入本出版物中，我們只是不知道，直到我們看到初稿為止。目前它們正在機構內進行準備和內部流通。

Okay. And with regard to the head and neck, has all the 10 patients been enrolled in the trials? What can you share with regard to that?

好的。至於頭頸部，這10名患者是否全部參加了試驗？對此您有什麼可以分享的嗎？

No. We're still a couple of patients short of our target -- enrollment target. And we -- I know you're at -- what you really want to know is when we're going to complete enrollment? We're hoping that that's going to take place before the end of the year. This is -- we found this to be a very, very difficult patient population to enroll for a whole variety of reasons, but we're confident that we'll be able to close out this study by the end of the year.

不。我們距離我們的目標——入組目標還有幾個病人。我們——我知道你在——你真正想知道的是我們什麼時候完成註冊？我們希望這將在今年年底之前實現。我們發現，由於各種原因，這是一個非常非常難以招募的患者群體，但我們有信心能夠在今年年底前結束這項研究。

Kumar, let me just add, on the CLL study, I did want to point out that vaccinations have already begun. It was just recent, a couple weeks ago we announced initiation of it, but there's -- there appears to be a strong building, I'll call it, queue of CLL patients interested in this.

Kumar，讓我補充一下，關於 CLL 研究，我確實想指出疫苗接種已經開始。就在最近，幾週前我們宣布啟動它，但似乎有一個強大的建築，我稱之為，對此感興趣的 CLL 患者隊列。

So the vaccinations have already started and there's quite a nice screening buildup in the background. And so the concept of this being fully enrolled within six months does not mean it'll be six months. We have to monitor the pace of it because it is an investigator initiated trial. And our anticipation is that we will be learning data as we go through and not simply waiting till the full ADR completed.

所以疫苗接種已經開始，並且在後台有相當好的篩查積累。因此，六個月內完全註冊的概念並不意味著需要六個月。我們必須監控它的進度，因為這是由研究者發起的試驗。我們的預期是，我們將在整個過程中學習數據，而不是簡單地等到完整的 ADR 完成。

(Operator Instructions) Jeffrey Kraws, Crystal Research Associates.

（操作員說明）Jeffrey Kraws，Crystal Research Associates。

Two of my questions were already answered leaving just one. With regard to the CMO4S1 and the Omicron variance, this is actually, I would think, a technology while COVID has died down given smallpox and some of the issues they're having in other countries. Are you seeing good response following that data that you presented, showing both the T-cell response as well as an immune response?

我的兩個問題已經得到解答，只剩下一個。關於 CMO4S1 和 Omicron 方差，我認為，這實際上是一項技術，而鑑於天花和其他國家/地區遇到的一些問題，新冠病毒已經消亡。根據您提供的數據，您是否看到良好的反應，顯示 T 細胞反應和免疫反應？

Yeah. I'll ask if Mark Newman would like to weigh in on this, because we've seen very promising, encouraging response with vaccine against the Omicron and Delta, basically all the way through XBB.1.5, but Mark?

是的。我會問 Mark Newman 是否願意對此發表意見，因為我們已經看到了針對 Omicron 和 Delta 的疫苗非常有希望、令人鼓舞的反應，基本上一直到 XBB.1.5，但是 Mark 呢？

Yeah, sure. Thank you, David. We have samples in the freezer from the Phase 1 and then we have what we call the safety lead in -- or the sentinels in the blood cancer studies that are evaluated in real time. And so one of the things you always do is go back and look at your samples and ask, well, okay, how did it work against the Wuhan and where we started? How does it work against Delta? How does it work against Omicron?

好，當然。謝謝你，大衛。我們的冰箱裡有第一階段的樣本，然後我們就有了所謂的安全線索——或者是實時評估的血癌研究中的哨兵。所以你經常做的一件事就是回去查看你的樣本並問，好吧，它是如何對抗武漢的以及我們從哪裡開始？它如何對抗達美航空？它如何對抗 Omicron？

And in fact, what we're finding, and this has been presented at a couple of vaccine meetings, is that we're getting great booster responses even in the cancer treatment patients. And in fact, I would say, surpassing initial expectations. This includes an increase in antibody responses that neutralize the variance from the original Wuhan through the Delta and into some of the Omicrons, including Omicron BA.1.2 and 1.5.

事實上，我們發現，即使在癌症治療患者中，我們也得到了很好的加強反應，這一點已經在幾次疫苗會議上提出過。事實上，我想說，超出了最初的預期。這包括抗體反應的增加，抵消了從最初的武漢到三角洲和一些 Omicron 的差異，包括 Omicron BA.1.2 和 1.5。

So we're always a little bit, I would say, behind, maybe three to four weeks behind. It takes that long to make the new constructs up. But it's very promising data and that we're seeing neutralization across to these other variants. And of course, we're seeing T-cell recognition to both the S and the N maintained at a high level.

所以我想說，我們總是落後一點，也許落後三到四個星期。建造新結構需要很長時間。但這是非常有希望的數據，我們看到這些其他變體的中和作用。當然，我們看到 T 細胞對 S 和 N 的識別都保持在高水平。

That was actually predictable because the virus is not varying the T-cell epitopes as much as it's varying the portion that the antibodies is recognizing.

這實際上是可以預見的，因為病毒改變 T 細胞表位的程度不如改變抗體識別的部分。

So yeah, it's all pointing in the right direction.

所以是的，一切都指向正確的方向。

Now, on the -- looking at the -- such populations with the various blood cancers, et cetera, as well as sickle cell, it's not widely recognized. While the sickle cell population in United States was less than 200,000, the sickle cell population in India is estimated to be 28 million. So that is an area I think you would have a lot of interest for not only partnering but a lot of interest for patient population treating because it's such a large market for them.

現在，看看患有各种血癌等以及鐮狀細胞病的人群，這一點尚未得到廣泛認可。美國的鐮狀細胞數量不足 20 萬，而印度的鐮狀細胞數量估計為 2800 萬。因此，我認為這是一個領域，您不僅對合作感興趣，而且對患者群體的治療也很感興趣，因為這對他們來說是一個巨大的市場。

That's true. Numerous groups within the -- I'll call it, the immunocompromised populations. People are still being sequestered in the United States who are CLL patients, people being sequestered in other parts of the world, whereas the rest of us know -- we don't even -- we barely remember wearing a mask. It seems like we're going about our lives.

這是真的。我將其稱為免疫功能低下人群中的許多群體。美國仍然有慢性淋巴細胞白血病患者被隔離，世界其他地方的人們也被隔離，而我們其他人知道——我們甚至不知道——我們幾乎不記得戴過口罩。看來我們還是要過自己的生活。

But there are these populations who have these medical conditions for -- for whom the current vaccines and monoclonal antibodies are inadequate and they're not leaving, they're not back to normal lives. They're still sequestered being kept indoors and that's why we saw a strong response and interest with the announcement of the initiation of the CLL booster trial.

但有些人患有這些疾病，目前的疫苗和單克隆抗體對他們來說還不夠，他們不會離開，也不會恢復正常生活。他們仍然被隔離在室內，這就是為什麼我們在宣布啟動 CLL 加強試驗時看到了強烈的反應和興趣。

There are no further questions at this time. I would like to turn the call back over to the presenters.

目前沒有其他問題。我想將電話轉回給演示者。

Thank you. Thank you everyone for participating in this corporate update and sharing in our achievements, progress and outlook. We're quite excited about what we're learning with these products. Gedeptin is continuing to show promise and encouragement, not just in head and neck cancers, but in the application of other areas. We think there's broad-based opportunity there and we'll keep you updated as more data comes in and as we learn more about that.

謝謝。感謝大家參與本次公司更新並分享我們的成就、進步和展望。我們對從這些產品中學到的東西感到非常興奮。 Gedeptin 不僅在頭頸癌方面，而且在其他領域的應用中，繼續展現出希望和鼓勵。我們認為那裡存在廣泛的機會，隨著更多數據的出現以及我們對此了解的更多信息，我們將隨時向您通報最新情況。

CMO4S1, as Mark Newman mentioned, it's exceeding probably expectations in terms of the promise and what we're looking forward to. We're highly encouraged with the interest we've received from various parties about that product and the opportunity, the broad base use of it. Again, we'll keep you updated as more data comes in, and at the same thing, as we progress with our MVA vaccine to become the first US-based supplier of such a vaccine and help the world supply, et cetera. And then of course, our manufacturing process improvement. So we'll keep you updated.

CMO4S1，正如馬克·紐曼（Mark Newman）提到的，就承諾和我們的期待而言，它可能超出了預期。各方對該產品及其機會及其廣泛使用的興趣使我們深受鼓舞。同樣，隨著更多數據的到來，我們將及時向您通報最新情況，同時，隨著我們的 MVA 疫苗取得進展，成為美國第一家此類疫苗的供應商，並幫助世界供應，等等。當然，我們的製造工藝也得到了改進。所以我們會及時向您通報最新情況。

Our focus is on accelerating to these milestone catalysts. Our goal is to deliver critically needed vaccines and immunotherapies to build shareholder and stakeholder value while providing highly motivating career development opportunities for our team. We take that very seriously. We want to acknowledge and thank our Board of Directors, our staff, and the many other parties who continue to support, advise, counsel and assist us as we move forward.

我們的重點是加速實現這些里程碑式的催化劑。我們的目標是提供急需的疫苗和免疫療法，以創造股東和​​利益相關者的價值，同時為我們的團隊提供高度激勵的職業發展機會。我們非常重視這一點。我們要感謝我們的董事會、員工以及在我們前進過程中繼續支持、建議、諮詢和協助我們的許多其他各方。

So thank you for your interest. Please circle back if you have further questions. We appreciate your time, attention, and interest. Thank you. Have a good day.

感謝您的關注。如果您還有其他問題，請回來。我們感謝您的時間、關注和興趣。謝謝。祝你有美好的一天。

This concludes today's conference call. You may now disconnect.

今天的電話會議到此結束。您現在可以斷開連接。