GeoVax Labs Inc (GOVX) 2023 Q3 法說會逐字稿

Good afternoon and welcome, everyone to the GeoVax Third Quarter 2023 corporate update call. My name is Mandy, and I will facilitate today's call. With me are David Dodd, Chairman and CEO; Mark Reynolds, Chief Financial 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 第三季公司更新電話會議。我叫曼迪，我將主持今天的通話。和我在一起的還有董事長兼執行長戴維‧多德 (David Dodd)；馬克‧雷諾茲，財務長； Kelly McKee 醫學博士、公共衛生碩士、首席醫療官；約翰‧夏基博士，業務發展副總裁。

(Operator Instructions) As a reminder, this conference is being recorded. At this time, I turn the call over to Max Gadicke of Stern IR. please note the following.

（操作員指示）謹此提醒，本次會議正在錄製中。這時，我把電話轉給了 Stern IR 的 Max Gadicke。請注意以下事項。

Thank you. Please note the following. Certain statements in this presentation may constitute forward-looking statements within the meanings 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。本簡報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。這些陳述是基於管理層目前的預期，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 weather 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 products. 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有重大差異，包括天氣 GeoVax 能否及時開發和製造具有所需特性的候選產品，並且此類產品對人類使用是安全的。 GeoVax 的疫苗將有效預防人類的針對性感染。 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 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聲明的義務，也不打算這樣做。有關這些因素的更多資​​訊包含在 GeoVax 向美國證券交易委員會提交的文件中，包括 GeoVax 表格 10-K 中作為風險因素列出的資訊。

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

現在我很高興向大家介紹 GeoVax 的董事長兼執行長 David Dodd。

Good afternoon and thank you for participating in the GeoVax corporate update call. This year and more specifically, during the third quarter, we have successfully advanced the progress of our development is focused on the two Phase 2 clinical stage products, while also advancing other critically important initiatives.

下午好，感謝您參加 GeoVax 公司更新電話會議。今年，更具體地說，在第三季度，我們成功地推進了我們的開發進度，重點是兩個二期臨床階段產品，同時也推進了其他至關重要的措施。

Today will address the progress status and plans related to give depth and currently in development as a therapy against advanced head and neck cancer and GEO-CM04S1, our next-generation COVID-19 vaccine.

今天將討論與深度治療和目前正在開發的晚期頭頸癌療法以及我們的下一代 COVID-19 疫苗 GEO-CM04S1 相關的進展狀況和計劃。

But first, I want to address the strategy behind our activities and why we are confident that we're on a course that will build significant shareholder and stakeholder value by delivering critically important differentiated products to improve lives worldwide. Following my comments, Mark Reynolds, our CFO, will provide an update of our financials and then your questions will be addressed.

但首先，我想談談我們活動背後的策略，以及為什麼我們有信心我們正在走一條透過提供極其重要的差異化產品來改善全球生活來建立顯著股東和利害關係人價值的路線。根據我的評論，我們的財務長馬克雷諾茲將提供我們財務狀況的最新信息，然後您的問題將得到解答。

Our strategy as GeoVax is to develop innovative cancer therapies and infectious disease vaccines that provide meaningful differentiation addressing important unmet medical needs, pursuing initial indications that support expedited registration pathways. We anticipate worldwide development, commercialization, and distribution via business partnerships and collaborations.

我們作為 GeoVax 的策略是開發創新的癌症療法和傳染病疫苗，提供有意義的差異化，解決重要的未滿足的醫療需求，尋求支持加速註冊途徑的初步適應症。我們預計透過業務夥伴關係和協作進行全球開發、商業化和分銷。

In other words, our strategy is reflected as innovate to differentiate, accelerate, and collaborate. It is this strategy that dictates our activities now and continuing through 2024. We are focused on our priorities in order to successfully implement our strategy.

換句話說，我們的策略體現為創新、差異化、加速和協作。正是這項策略決定了我們現在並持續到 2024 年的活動。我們專注於我們的優先事項，以便成功實施我們的策略。

It is critically important that we advance through catalysts and milestones that demonstrate the differentiated value of our developments while strengthening the confidence and support from our investors and other key stakeholders.

至關重要的是，我們要透過催化劑和里程碑來推進，以展示我們發展的差異化價值，同時增強投資者和其他主要利害關係人的信心和支持。

In addition, we're addressing opportunities that provide us a basis for achieving leadership within those targeted patient areas and commercial markets that's why our current clinical stage products, Gedeptin, and GEO-CM04S1 provide us the potential of achieving leadership in those respective populations.

此外，我們正在尋找機會，為我們在這些目標患者領域和商業市場中取得領導地位奠定基礎，這就是為什麼我們目前的臨床階段產品Gedeptin 和GEO-CM04S1 為我們提供了在這些各自人群中取得領導地位的潛力。

These represent areas where a much larger competitors either aren't addressing such patients, perhaps due to their relatively small size of those opportunities, such as the case for advanced head and neck cancer or their technologies are inadequate to address their respective patient populations such as immunocompromised patients relative to the current authorized COVID-19 vaccines.

在這些領域，規模大得多的競爭對手要么無法解決此類患者的問題，可能是因為這些機會相對較小，例如晚期頭頸癌的病例，要么他們的技術不足以解決各自的患者群體，例如與目前授權的COVID-19 疫苗相關的免疫功能低下患者。

Also, [GEONVA], our vaccine against mpox and smallpox is intended to disrupt the existing monopoly in that important area, providing us leadership as the first US-based suppliers such a vaccine. I'll reiterate this since we hold worldwide rights for our products. We are highly focused and engaged in discussions to ensure worldwide access and commercialization.

此外，[GEONVA]，我們針對mpox和天花的疫苗旨在打破這一重要領域的現有壟斷，使我們成為美國第一家此類疫苗供應商的領導地位。我會重申這一點，因為我們擁有我們產品的全球權利。我們高度專注並參與討論，以確保全球範圍內的訪問和商業化。

Finally, we really realized that adaptability to changing market conditions, emerging competitors, and other challenges required to achieve and maintain sustainability and success. The principles of focus, leadership, and adaptability are the foundation for implementing our strategy and progressing to successful growth and development.

最後，我們真正意識到，要實現並維持永續性和成功，就必須適應不斷變化的市場條件、新興競爭對手以及其他挑戰。專注、領導力和適應性原則是實施我們的策略並取得成功成長和發展的基礎。

This is not only relevant to our portfolio development activities, but also relative to our financing strategy, which includes equity proceeds, non-dilutive funding opportunities, and capital resulting from business development activities.

這不僅與我們的投資組合開發活動有關，還與我們的融資策略有關，其中包括股權收益、非稀釋性融資機會以及業務開發活動產生的資本。

We believe that having this multi-prong strategy relative to capital development provides us the ability to continue to support our development priorities in the current challenging economic market environment.

我們相信，這種與資本開發相關的多管齊下策略使我們有能力在當前充滿挑戰的經濟市場環境中繼續支持我們的發展重點。

The vast array of unmet medical needs within oncology represents significant opportunities to advance novel approaches addressing various cancer patient needs worldwide. Increasingly, we are participating in various oncology conferences, some of which we expect to present a Gedeptin clinical data and with others conduct partnering discussions.

腫瘤學領域大量未滿足的醫療需求為推動滿足全球各種癌症患者需求的新方法提供了重要機會。我們越來越多地參加各種腫瘤學會議，我們希望在其中一些會議上展示 Gedeptin 臨床數據，並與其他會議進行合作討論。

Gedeptin is based on a novel patented technology for the treatment of solid tumors through a gene therapy strategy, known as gene-directed enzyme prodrug therapy or GDEPT. In GDEPT, a vector is used to selectively transduce tumor cells with a nonhuman gene, which expresses an enzyme that can convert a non-toxic prodrug into a highly toxic anti-tumor compound in cyto.

Gedeptin 是基於一種透過基因治療策略治療實體瘤的新型專利技術，稱為基因定向酶前藥療法或 GDEPT。在GDEPT中，載體被用來選擇性地用非人類基因轉導腫瘤細胞，該基因表達一種酶，可以將無毒的前藥轉化為細胞內高毒性的抗腫瘤化合物。

Gedeptin is tumor agnostic, meaning that it provides the opportunity to address a variety of solid tumors, either cancer or fludarabine. We hold worldwide rights for all indications of this technology or as we call it this pipeline technology.

Gedeptin 與腫瘤無關，這意味著它提供了治療各種實體瘤（癌症或氟達拉濱）的機會。我們擁有該技術或我們稱之為管道技術的所有適應症的全球權利。

Annually in the US, there are 67,000 new cases of head and neck cancers with approximately 15,000 deaths. Worldwide, there are approximately 900,000 new cases of head and neck cancers annually and approximately 400,000 deaths.

美國每年新增 67,000 例頭頸癌病例，其中約 15,000 人死亡。在世界範圍內，每年約有 90 萬例新發頭頸癌病例，約 40 萬例死亡。

Our initial targeted patient population for the application of Gedeptin represents those who are in stage care 15,000 in the US and the 400,000 worldwide. These patients represent a critical unmet medical need. Many are unable to swallow food and have difficulty speaking, most have exhausted existing therapies and standard of care. Typically, they're receiving palliative care. Our goal is to provide an improved in-state quality of life by reducing and or eliminating various targeted tumors.

我們最初應用 Gedeptin 的目標患者群體包括美國 15,000 名接受階段護理的患者和全球 400,000 名接受階段護理的患者。這些患者代表了未滿足的關鍵醫療需求。許多人無法吞嚥食物並且說話有困難，大多數人已經用盡了現有的療法和標準護理。通常，他們正在接受安寧療護。我們的目標是透過減少和/或消除各種靶向腫瘤來改善州內的生活品質。

The protocol entails up of the five treatment cycles, each consisting of three intra-tumoral injections of Gedeptin over two days, followed by infusion of a prodrug, fludarabine phosphate, once daily for three days. The Phase 1 dose-ranging study demonstrated that treating a tumor with a single cycle of Gedeptin, followed by fludarabine infusions, was well tolerated, with evidence of a reduction in tumor size in patients with solid tumors.

此方案需要五個治療週期，每個週期包括在兩天內進行三次腫瘤內注射 Gedeptin，然後輸注前藥磷酸氟達拉濱，每天一次，持續三天。第一階段劑量範圍研究表明，以單週期 Gedeptin 治療腫瘤，然後輸注氟達拉濱，耐受性良好，有證據表明實體瘤患者的腫瘤尺寸有所減少。

As a result of that study, the FDA is funding the current trial under the Orphan Drug Clinical Trials Program. In July, this data from the current multisite trial was presented at the AACR-AHNS International Conference in Montreal. That presentation included results from the initial eight of the targeted 10 patients enrolled.

這項研究的結果，FDA 正在資助孤兒藥物臨床試驗計畫下的當前試驗。 7 月，目前多中心試驗的數據在蒙特利爾舉行的 AACR-AHNS 國際會議上公佈。該演示包括 10 名目標患者中最初 8 名的結果。

As noted in the press release issued at that time, the administration of Gedeptin was shown to be safe and feasible. We expect to complete this initial trial by the end of Q1 2024. And to review our recommendations for an expanded Phase 2 trial with the FDA focused on an expedited path to registration.

正如當時發布的新聞稿中指出的那樣，Gedeptin 的給藥已被證明是安全可行的。我們預計在 2024 年第一季末完成這項初步試驗。並與 FDA 一起審查我們關於擴大 2 期試驗的建議，重點是加快註冊路徑。

In the interim, we are discussing partnerships and collaborations in support of worldwide development and commercialization of Gedeptin and against very solid tumors, both as monotherapy and as combination therapy in conjunction with immune checkpoint inhibitors.

在此期間，我們正在討論夥伴關係和合作，以支持 Gedeptin 在全球範圍內的開發和商業化，並針對非常實體瘤，作為單一療法和與免疫檢查點抑製劑聯合的聯合療法。

Turning now to COVID-19, 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 more durable protection than the current vaccines.

現在轉向COVID-19，CM04S1，我們的下一代COVID-19 疫苗與目前授權的COVID-19 疫苗不同，它針對的是免疫系統的抗體和細胞臂，專注於提供比傳統疫苗更強大、更持久的保護。目前的疫苗。

This is critically important addressing the high-risk populations of immune compromised individuals, those 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風險族群至關重要，目前的疫苗和單株抗體療法對這些人來說是不夠的。這些人群包括患有各種血癌、腎臟疾病、鐮狀細胞性貧血、HIV陽性、狼瘡等自體免疫疾病的人群，以及接受免疫抑制治療的人。

In general, patient groups with a bladed immune systems unable to respond adequately to the approved mRNA vaccines are at such a high risk. In the US, there are approximately 15 million immune-compromised individuals. Worldwide, there are an estimated 240 plus million.

一般來說，免疫系統脆弱、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。在美國，大約有 1500 萬免疫力低下的人。全世界估計有 240 多萬。

There's 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 currently in clinical development.

迫切需要下一代 COVID-19 疫苗來支持這些人，我們相信 CM04S1 是目前臨床開發中領先的下一代疫苗。

During second quarter of this year, the White House announced Project NextGen, a $5 billion initiative, the follow-on from Operation Warp Speed, seeking COVID-19 vaccine with enhanced breadth of protection against variants and improved durability being particularly interested in novel vaccine candidates already in clinical trials.

今年第二季度，白宮宣布了NextGen 項目，這是一項50 億美元的計劃，是「曲速行動」的後續行動，旨在尋求具有更廣泛的針對變體的保護範圍和更高的耐用性的COVID-19 疫苗，對新型候選疫苗特別感興趣已經在臨床試驗中。

We believe the CM04S1 is a prime example 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 CM04S1 是下一代 COVID-19 疫苗的典型例子。我們在國內和國際上都對參與我們的臨床開發項目抱持極大的興趣。我們認為，由於我們重點關注當前 COVID-19 疫苗和單株抗體療法無法服務的高風險族群，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援全球商業化和分銷。

Regarding Project NextGen, we are currently in active discussions related to full participation in this initiative. Of the $5 billion funding, so far, 1.9 billion has been award, resulting in 3.1 billion remaining to be awarded. Project NextGen leadership has indicated their expectation to award the full 5 billion with additional awards to be announced by year end. We hope to provide further updates soon.

關於 Project NextGen，我們目前正在積極討論全面參與該計劃。迄今為止，在 50 億美元的資金中，已撥款 19 億美元，尚待撥款 31 億美元。 NextGen 計畫領導層已表示，他們希望獎勵全部 50 億美元，並在年底前宣布額外獎勵。我們希望盡快提供進一步的更新。

For the remainder of 2023 and 2024, we are focused on accelerating efforts in support of the Gedeptin and CMO4S1 Phase 2 clinical programs, as well as advancing our MVA vaccine specific to mpox and smallpox into development and further progress of our program focused on the advanced MVA manufacturing system.

在 2023 年和 2024 年剩餘的時間裡，我們的重點是加快支持 Gedeptin 和 CMO4S1 2 期臨床計劃，以及推進我們針對mpox和天花的 MVA 疫苗的開發和我們的計劃的進一步進展，重點是先進的MVA製造系統。

In 2024, this will include the further reporting of results from our CMO4S1 Phase 2 programs, including results from the healthy volunteer booster program. Completion of enrolment in our results from the immunocompromised CLL trial and additional site initiations and further results from our immunocompromised stem cell transplant trial.

2024 年，這將包括進一步報告我們的 CMO4S1 第 2 階段計畫的結果，其中包括健康志工加強計畫的結果。完成了免疫功能低下 CLL 試驗的結果登記和其他站點啟動以及免疫功能低下幹細胞移植試驗的進一步結果。

for Gedeptin in 2024, we expect to report the final results from the current trial and our plans for the expanded Phase 2 trial. We also expect to report plans regarding the next steps related to evaluating Gedeptin in this combination therapy used in conjunction with immune checkpoint inhibitors.

對於 2024 年的 Gedeptin，我們預計將報告目前試驗的最終結果以及擴大 2 期試驗的計畫。我們也期望報告有關評估 Gedeptin 與免疫檢查點抑制劑合併治療的後續步驟的計劃。

Relative to GEONVA against imports of smallpox, we anticipate reporting in 2024 regulatory path and plans related to advancing that product towards registration.

相對於進口天花的 GEONVA，我們預計將在 2024 年報告與推進該產品註冊相關的監管路徑和計畫。

Finally, next year, we'll continue to provide updates related to our advanced MVA manufacturing process targeted to enable GeoVax to effectively produce and distribute MVA based vaccines in response to real time market needs.

最後，明年，我們將繼續提供與先進 MVA 製造流程相關的更新，旨在使 GeoVax 能夠有效生產和分銷基於 MVA 的疫苗，以滿足即時市場需求。

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?

現在我想將簡報交給 GeoVax 財務長 Mark Reynolds，以審查我們最近的業績和財務狀況。標記？

Thank you, David.

謝謝你，大衛。

I'll start the financial review with our income statement. We had no active grants during 2023, so we reported no grant revenues as compared to a small amount in 2022. However, as David has noted, we are having ongoing discussions with Garden Project NextGen, If, an award were to be made by BARDA to GeoVax, this could become a very important component of our financing mix in the future.

我將從我們的損益表開始進行財務審查。我們在 2023 年沒有活躍的贈款，因此與 2022 年的少量贈款相比，我們報告沒有贈款收入。但是，正如 David 所指出的，我們正在與 Garden Project NextGen 進行持續討論，如果 BARDA 授予獎項對於GeoVax 來說，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。

In this regard there, I'll say that there is no award to date and there are no guarantees that will be one, so I'll refer everyone back to the forward-looking statements disclaimer at the beginning of this call as all of our comments regarding Project NextGen are forward-looking statements.

在這方面，我要說的是，迄今為止還沒有獲獎，也不能保證會獲獎，所以我將請大家回顧本次電話會議開始時的前瞻性聲明免責聲明，因為我們所有的有關NextGen 項目的評論屬於前瞻性陳述。

Research and development expenses were 6.9 million and 14.5 million for the three-month and nine-month periods in 2023 versus 2.7 million and 5.4 million, respectively in 2022.

2023 年三個月和九個月期間的研發費用分別為 690 萬美元和 1,450 萬美元，而 2022 年分別為 270 萬美元和 540 萬美元。

These increases are primarily associated with clinical trial activity for the CMO4S1 and get opt-in programs, which includes manufacturing costs clinical trial materials. The increase is also reflective of higher personnel costs as we brought on two additional executive-level employees in early 2023, adding depth to our regulatory and quality control functions.

這些增長主要與 CMO4S1 的臨床試驗活動和選擇加入計劃有關，其中包括臨床試驗材料的製造成本。這一成長也反映出人員成本上升，因為我們在 2023 年初增加了兩名高階主管級員工，從而增強了我們的監管和品質控制職能的深度。

General administrative expenses were 1.7 million and $4.6 million for the three-month and nine-month periods in 2023 versus 1.2 million and $3.4 million in 2022, with the increases mostly associated with higher personnel and consulting costs, patent costs, and investor relations expenses.

2023 年三個月和九個月期間的一般管理費用分別為170 萬美元和460 萬美元，而2022 年分別為120 萬美元和340 萬美元，成長主要與人員和諮詢成本、專利成本和投資者關係費用增加有關。

Interest income was 675,023 versus just 4,000 in 2022, reflecting increasing interest rates available through our money market accounts. So overall, net loss for the nine month period of '23 was by 18 million or $0.69 per share versus $8.6 million in 2022 or $0.63 per share, again, with the increase being driven by the CMO4S1 and Gedeptin clinical trial activity.

利息收入為 675,023，而 2022 年僅為 4,000，反映出透過我們的貨幣市場帳戶提供的利率不斷增加。因此，整體而言，2023 年9 個月期間的淨虧損為1,800 萬美元，即每股0.69 美元，而2022 年為860 萬美元，即每股0.63 美元，這一增長也是由CMO4S1 和Gedeptin 臨床試驗活動所推動的。

Turning now to the balance sheet, and our cash balances at September 30 were approximately 12.7 million as compared to 27.6 million at the end of 2022. The change in our cash balances is reflective of 14.9 million used in operating activities. There were no significant financing or investing activities, so far during 2023.

現在轉向資產負債表，截至 9 月 30 日，我們的現金餘額約為 1,270 萬美元，而 2022 年底為 2,760 萬美元。我們現金餘額的變化反映了經營活動中使用的 1,490 萬美元。 2023 年迄今為止，沒有重大融資或投資活動。

Our outstanding common shares currently stand at 26.7 million.

我們已發行的普通股目前為 2,670 萬股。

So going forward of funding, our ongoing Phase 2 clinical programs for CMO4S1 and Gedeptin will continue to be the most significant use of our cash going into '24. We don't expect this prioritization of our spending to change if we receive a Project NextGen award from BARDA, and any incremental spending for that program will be funded by the award.

因此，在資金方面，我們正在進行的 CMO4S1 和 Gedeptin 2 期臨床計畫將繼續成為我們進入 24 年現金最重要的用途。如果我們獲得 BARDA 頒發的 Project NextGen 獎項，我們預計我們的支出優先順序不會改變，並且該計劃的任何增量支出都將由該獎項資助。

We do expect to raise additional capital to fund our programs in 2024, and we intend to do that in conjunction with positive news flow. I'll be happy to answer any questions to the Q&A, and I'll now turn the call back to David.

我們確實希望在 2024 年籌集更多資金來資助我們的項目，並且我們打算結合積極的消息來實現這一目標。我很樂意回答問答中的任何問題，現在我會將電話轉回給 David。

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。現在我和我的同事回答大家的問題。參加我們問答環節的有 Mark Newman 博士、Kelly McKee 和 John Sharkey；我們的首席科學官；首席醫療官;分別是業務開發副總裁。

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

我現在將把電話轉給接線員，以獲取有關問答階段的說明。

We will now begin the question-and-answer session. (Operator Instructions)

我們現在開始問答環節。 （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.

大家好，祝賀所有的進展。

I have kind of a tangential question, but I think it's important. There have been a tremendous number of COVID reinfection was people who had COVID, recovered from it, and now they're getting it again, and I noticed that the emergency use authorization is now approved for Pfizer's Paxlovid. And Paxlovid is getting prescribed quite a lot. So, I'm just wondering how this impacts the marketplace and does it impact immune compromised patients at all?

我有一個無關緊要的問題，但我認為這很重要。已經有大量的新冠病毒再次感染者，即那些患有新冠病毒、康復了的人，現在他們又再次感染了新冠病毒，我注意到輝瑞的 Paxlovid 的緊急使用授權現已獲得批准。 Paxlovid 的處方量相當大。所以，我只是想知道這對市場有何影響？它是否會影響免疫受損的患者？

Thank you, Jason. And what I'll do is, I'll make a couple of comments on my thoughts on this and then Kelly, I'll ask, if you'd like to add to it. But first of all, say that I don't think it impacts the immunocompromised at all because it's been shown that they're not responding well to the monoclonal antibodies either as a Synarel or Paxlovid. So, I think that's unchanged. There's still a tremendous need for a vaccine such as ours that will address their needs because they've been unmet since the beginning of the introduction of the vaccine sooner. So I think from that standpoint, there's just really no impact or anything further under underscores the importance of what we have in development.

謝謝你，傑森。我要做的是，我會就我對此的想法發表一些評論，然後凱利，我會問你是否願意補充。但首先，我認為它根本不會影響免疫功能低下的人，因為研究表明，他們對 Synarel 或 Paxlovid 等單株抗體的反應不佳。所以，我認為這一點沒有改變。我們仍然非常需要像我們這樣的疫苗來滿足他們的需求，因為自從更早推出疫苗以來，他們的需求一直沒有得到滿足。所以我認為從這個角度來看，實際上沒有任何影響，或任何進一步強調我們開發的重要性。

Kelly, do you want to add anything?

凱莉，你想補充什麼嗎？

Yeah, just a couple of thoughts. I mean, first of all, as far as the impact on the vaccine market overall, I mean, I think everybody sort of recognizes that currently with the mRNA vaccine sales have been and certainly lower than they were at the in the first stages of the pandemic for sure. And there's so many factors that impact that and that sort of issue of recurrent infections or breakthrough infections is only a component of that.

是的，只是一些想法。我的意思是，首先，就對整個疫苗市場的影響而言，我認為每個人都認識到，目前 mRNA 疫苗的銷量肯定低於第一階段的水平。大流行是肯定的。影響這一點的因素有很多，而反覆感染或突破性感染的問題只是其中的一個組成部分。

So I'm not sure you can sort of parse those issues on efficiently as far as is the impact on the immunocompromised population. I mean, we're sort of talking apples and oranges. Paxlovid is a therapeutic recourse and we've got a vaccine to offer in, I think by anybody's measure, if we can prevent people from getting sick particularly for those -- it keeps them from getting severely ill for better off than having to rely on a therapeutic and antiviral therapeutic that number one isn't 100% effective and number two as some substantial sort of side effects that you prefer not to deal with, not the least of which is the sort of long COVID syndrome seems to sort of appear in people after they stop taking Paxlovid.

因此，我不確定您是否可以有效解析這些問題對免疫功能低下人群的影響。我的意思是，我們有點像在談論蘋果和橘子。 Paxlovid 是一種治療手段，我認為以任何人的標準來看，如果我們能夠防止人們生病，特別是對於那些人來說，我們就可以提供一種疫苗——它可以防止他們患上重病，從而使他們的生活比依賴依賴更好。一種治療和抗病毒療法，第一不是 100% 有效，第二是你不想處理的某種實質副作用，其中最重要的是似乎出現在人們在停止服用Paxlovid 後。

And so, it shouldn't impact us at all and whether it hasn't as what the influences on the wider land vaccine landscape, I can't really. I don't know.

因此，它根本不應該影響我們，無論它對更廣泛的陸地疫苗領域有什麼影響，我真的不能。我不知道。

Well, I was just what I see in the real world is a very large segment of the population does not want to get a fourth, fifth, and sixth mRNA booster. they are hearing that Paxlovid does have some side effects, metallic taste in the mouth, principally, but it's pretty effective at knocking virus down. But you're right, there is a lag. And I think a segment of the population would really like an mRNA alternative and I'm really wondering, is that might that not be a market segment that in addition to immune-compromised patients kind of becomes very attractive to you?

嗯，我在現實世界中看到的是，很大一部分人不希望獲得第四、第五和第六個 mRNA 增強劑。他們聽說 Paxlovid 確實有一些副作用，主要是嘴裡有金屬味，但它在擊倒病毒方面非常有效。但你是對的，有一個滯後。我認為一部分人真的很喜歡 mRNA 替代品，我真的很想知道，除了免疫功能低下的患者之外，這是否不是一個對您非常有吸引力的細分市場？

(multiple speaker) Go ahead, Kelly, I'm sorry.

（多位發言者）請繼續，凱利，對不起。

While she's going to say, I mean, when you say they prefer an mRNA option, I think the mRNA or kind of what they have currently available to them. One of the big advantage that I think our vaccine offers is sort of an alternative approach to immunization, where we can provide sort of broad durable immune protection that won't require, shouldn't, I should say, require frequent once or twice a year boosting in order to maintain immune protective status.

雖然她會說，我的意思是，當你說他們更喜歡 mRNA 選項時，我認為 mRNA 或他們目前可用的某種東西。我認為我們的疫苗提供的一大優勢是一種替代的免疫方法，我們可以提供一種廣泛的持久的免疫保護，不需要，我應該說，不需要頻繁地進行一次或兩次年加強以維持免疫保護狀態。

Well. I was going to add, Jason. I was going to add that as the data comes out from the recently fully enrolled trial, where it's the healthy volunteers receiving our vaccine as a booster. I think that data may be demonstrative of sort of what Kelly was just touching on, maybe that our breadth of protection and the durability that's delivered from this dual antigen approach is going to have to give something that will be a value that they are not receiving from the mRNA.

出色地。我想補充一點，傑森。我想補充一點，因為數據來自最近完全入組的試驗，其中健康志願者接受了我們的疫苗作為加強劑。我認為這些數據可能說明了凱利剛剛談到的內容，也許我們透過這種雙抗原方法提供的保護範圍和耐久性必須提供一些他們沒有收到的價值來自 mRNA。

In a prior life, I was involved in pharmaceutical sales. So, a year from now before you hire a pharmaceutical sales manager, you should give me a call.

前世，我從事藥品銷售工作。因此，一年後，在您僱用藥品銷售經理之前，您應該打電話給我。

Okay, we'll do that.

好的，我們就這麼做。

Alright guys, thank you so much.

好的，夥計們，非常感謝你們。

Thank you.

謝謝。

(Operator Instructions)

（操作員說明）

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

我們的問答環節到此結束。現在我將把會議轉回給大衛·多德（David Dodd）發表閉幕詞。

Well, thank you for everyone who weren't that many questions that we have a new sales manager coming in a year from now, I guess. But anyway, I want to thank everyone for participating in the call. We appreciate your interest. And I'd just say that again, to reiterate, our strategy we're focused on is to innovate to differentiate to accelerate to the market and to do this, while collaborating and that reflects our focus towards building significant shareholder share at a total value.

好吧，謝謝大家提出的問題，我猜一年後我們將迎來一位新的銷售經理。但無論如何，我要感謝大家參與這場電話會議。我們感謝您的關注。我只想再說一遍，重申一下，我們重點關注的策略是創新，實現差異化，加速進入市場，並在合作的同時做到這一點，這反映了我們致力於在總價值上建立重要的股東份額。

I want to acknowledge and thank the our Board of Directors, our staff, and the many other parties that continue to support that buys us towards achieving success. We're committed to providing meaningful career development opportunities for highly competitive quality-oriented members of our team. We're seeking disrupt the current paradigm of both cancer therapies, infectious disease, vaccines, and redefining how their success, in fact, define and addressing various patient populations.

我要感謝我們的董事會、我們的員工以及許多其他持續支持我們成功的各方。我們致力於為團隊中具有高度競爭力、注重品質的成員提供有意義的職業發展機會。我們正在尋求顛覆癌症治療、傳染病、疫苗的當前範式，並重新定義它們的成功實際上如何定義和解決不同的患者群體。

So, I want to wish everyone a wonderful day. Thank you, and we look forward to keeping you updated as we go forward.

所以，我想祝大家有個美好的一天。謝謝您，我們期待為您提供最新進展。

Thank you.

謝謝。

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

會議現已結束。感謝您參加今天的演講。您現在可以斷開連線。