GeoVax Labs Inc (GOVX) 2024 Q2 法說會逐字稿

Good afternoon and welcome everyone to the GeoVax second quarter 2024 corporate update Call. My name is Alex and I will facilitate today's call.

下午好，歡迎大家參加 GeoVax 2024 年第二季企業更新電話會議。我叫亞歷克斯，我將主持今天的電話會議。

With me are David Dodd, Chairman and CEO; Mark Reynolds, Chief Financial Officer; Mark Newman, PhD, Chief Scientific Officer; Kelly McKee, MD, MPH, Chief Medical Officer; and John Sharkey, PhD, Vice President, Business Development. (Operator Instructions) as a reminder, this conference is being recorded.

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；馬克紐曼博士，首席科學官； 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。 （操作員指示）提醒一下，本次會議正在錄製中。

At this time, I am turning the call over to Max Gadicke of Precision HQ.

目前，我將把電話轉給 Precision 總部的 Max Gadicke。

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.

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。

These statements are based on management's current expectations 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,

這些陳述是基於管理層目前的預期，可能會受到不確定性和情況變化的影響。由於多種因素，實際結果可能與這些陳述中包含的結果有重大差異，包括是否：

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,

GeoVax 可以及時開發和製造具有所需特性的候選產品，而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，

There is development of competitive products that may be more effective or easier to use than GeoVax products, GeoVax will be able to enter into favorable manufacturing and distribution agreements and other factors over which GeoVax has no control.

正在開發比 GeoVax 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 at 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 中列出的風險因素。

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。

Thank you, Max. Good afternoon and thank you for participating in the second quarter 2024 GeoVax corporate update call. Following my comments, Mark Reynolds, our CFO, will provide an update of our financials and then your questions will be addressed.

謝謝你，麥克斯。下午好，感謝您參加 2024 年第二季 GeoVax 公司更新電話會議。根據我的評論，我們的財務長馬克雷諾茲 (Mark Reynolds) 將提供我們財務狀況的最新信息，然後將解答您的問題。

The second quarter included several major events in the development of GeoVax, led by the BARDA Project NextGen award, valued at almost $400 million, supporting GEO-CM04S1, our next generation COVID-19 vaccine, in a Phase IIb 10,000 patient trial, comparing our vaccine to an FDA-authorized mRNA vaccine. This program is already underway, with our having already initiated billings to BARDA as Mark will further discuss during the financial review.

第二季度包括GeoVax 開發中的幾項重大事件，由BARDA Project NextGen 獎項牽頭，價值近4 億美元，支持我們的下一代COVID-19 疫苗GEO-CM04S1，在IIb 期10,000 名患者試驗中，比較了我們的下一代疫苗FDA 授權的 mRNA 疫苗的疫苗。該計劃已經在進行中，我們已經開始向 BARDA 開出帳單，Mark 將在財務審查期間進一步討論。

We're delighted to be partnered with Allucent as our CRO for the Project NextGen trial, as Allucent is our existing CRO supporting both our CM04S1 and Gedeptin clinical trials.

我們很高興與 Allucent 合作，作為我們 NextGen 計畫試驗的 CRO，因為 Allucent 是我們現有的 CRO，支持我們的 CM04S1 和 Gedeptin 臨床試驗。

In addition, during Q2, we conducted a comprehensive review of the Gedeptin Phase Ib, IIa trial in conjunction with the Gedeptin clinical advisory committee deciding to proceed with the implementation of a Phase II trial evaluating Gedeptin in combination with an immune check inhibitor as therapy for patients with squamous cell head and neck cancer.

此外，在第二季度，我們與 Gedeptin 臨床諮詢委員會一起對 Gedeptin Ib、IIa 期試驗進行了全面審查，決定繼續實施一項 II 期試驗，評估 Gedeptin 與免疫檢查抑製劑聯合治療患有鱗狀細胞頭頸癌的患者。

Thus far, clinical evaluation of Gedeptin therapy has demonstrated sufficient tumor stabilization or reduction activity to support plans to advance clinical development of Gedeptin in such an expanded Phase II clinical trial. These two events and decisions represent significant milestones for GeoVax.

迄今為止，Gedeptin 療法的臨床評估已證明有足夠的腫瘤穩定或減少活性，以支持在此類擴大的 II 期臨床試驗中推進 Gedeptin 臨床開發的計劃。這兩個事件和決定代表了 GeoVax 的重要里程碑。

Today, we'll discuss the progress, status and plans related to CM04S1 and Gedeptin, as well as provide updates on our other programs, including our progress in the advanced MVA manufacturing process.

今天，我們將討論與 CM04S1 和 Gedeptin 相關的進展、狀態和計劃，並提供我們其他項目的最新信息，包括我們在先進 MVA 製造工藝方面的進展。

Our goal is to successfully develop innovative cancer therapies and infectious disease vaccine, addressing critically important unmet medical needs, pursuing initial indications that support expedited registration pathways. We anticipate establishing business partnerships and collaborations in support of worldwide development, commercialization and distribution.

我們的目標是成功開發創新的癌症療法和傳染病疫苗，解決至關重要的未滿足的醫療需求，尋求支持加速註冊途徑的初步適應症。我們期望建立業務夥伴關係和協作，以支援全球開發、商業化和分銷。

Last December, we announced the closure of enrollment for the Phase Ia IIb trial of Gedeptin among advanced head and neck cancer patients. This initial targeted patient population represents those who are in end-stage care who unfortunately die each year as a result of head and neck cancer. This represents 17,000 in the US and over 400,000 individuals worldwide.

去年 12 月，我們宣布終止 Gedeptin 在晚期頭頸癌患者的 Ia IIb 期試驗的招募。這個最初的目標患者群體代表了那些每年不幸死於頭頸癌的末期護理患者。這代表了美國的 17,000 人以及全球超過 40 萬人。

Our goal is to obtain clinical evidence supporting advancement of this therapy, including in patients with earlier stage disease.

我們的目標是獲得支持該療法進展的臨床證據，包括早期疾病患者。

You recall this trial was funded by the FDA under the orphan drugs clinical trials program. The April comprehensive review of the results from the Phase I and the most recent Phase Ia IIb trial of Gedeptin concluded that Gedeptin has demonstrated acceptable safety and efficacy to support continued development of a Phase II trial and first recurrence head and neck cancer.

您還記得這項試驗是由 FDA 根據孤兒藥臨床試驗計劃資助的。4 月對 Gedeptin 的 I 期和最近的 Ia IIb 期試驗結果進行的全面審查得出結論，Gedeptin 已表現出可接受的安全性和有效性，以支持 II 期試驗和首次復發頭頸癌的持續開發。

The primary goal of this trial will be to establish efficacy of neoadjuvant Gedeptin therapy combined with an immune checkpoint inhibitor in squamous cell head and neck cancer.

本試驗的主要目標是確定新輔助 Gedeptin 療法合併免疫檢查點抑制劑治療鱗狀細胞頭頸癌的療效。

The company has initiated the necessary planning activities, including protocol development, manufacturing and CRO selection, with the trial activation anticipated during the first half of 2025.

該公司已啟動必要的規劃活動，包括方案開發、製造和 CRO 選擇，預計將於 2025 年上半年啟動試驗。

We believe that the Gedeptin mechanism of action will enable us to address a variety of solid tumors, both cancerous and benign. We hold worldwide rights for all indications of this technology and we are participating in various oncology and partnering conferences. We anticipate funding the expanded Phase II trial through a combination of internal funding, potential partnering and potential non-diluted funding resources. During the Q&A session, we welcome the opportunity to further discuss our plan for the expanded Phase II trial.

我們相信 Gedeptin 的作用機制將使我們能夠治療多種實體腫瘤，包括癌性和良性腫瘤。我們擁有該技術所有適應症的全球權利，並且我們正在參加各種腫瘤學和合作會議。我們預計透過內部資金、潛在合作和潛在非稀釋資金資源的結合來為擴大的第二階段試驗提供資金。在問答環節中，我們歡迎有機會進一步討論我們擴大二期試驗的計畫。

Our big news during Q2, however, was the announcement of the BARDA Project NextGen award of almost $400 million, supporting CM04S1 and a 10,000-patient comparative trial against an FDA-authorized mRNA vaccine.

然而，我們在第二季度的重大新聞是宣布獲得近 4 億美元的 BARDA Project NextGen 獎項，用於支持 CM04S1 和一項針對 FDA 授權的 mRNA 疫苗的 10,000 名患者的比較試驗。

This announcement and award represent a highly significant event in the evolution of our company which we believe represents a strong validation of our MVA technology and expertise.

這項公告和獎項代表了我們公司發展過程中的一個非常重要的事件，我們相信這代表了對我們 MVA 技術和專業知識的有力驗證。

The vetting process was lengthy and rigorous but we remained confident throughout and were delighted to be part of the Project NextGen vaccine program.

審查過程漫長而嚴格，但我們始終保持信心，並很高興成為 NextGen 疫苗計劃的一部分。

Our aim with CM04S1 is to provide a more practical, public health-friendly COVID-19 vaccine than that offered from the first-generation vaccines. We believe that this is achieved by stimulating a robust and durable immune response across multiple virus variants as a result of the induction of both the antibody and cellular arms of the immune system against multiple virus antigens.

我們 CM04S1 的目標是提供一種比第一代疫苗更實用、更有利於公共衛生的 COVID-19 疫苗。我們相信，這是透過刺激跨多種病毒變體的強大而持久的免疫反應來實現的，這是誘導免疫系統針對多種病毒抗原的抗體和細胞臂的結果。

This distinction is critically important in addressing the high-risk populations of immune-compromised individuals for whom the current vaccines and monoclonal antibody therapies are typically inadequate. This represents the key differentiation between our vaccine and the first-generation approved vaccines.

這種區別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通常不足以治療這些族群。這是我們的疫苗與第一代批准的疫苗之間的關鍵區別。

Our vaccine utilizes a proven safe and efficient delivery platform, Modified Vaccinia Ankara, or MVA which does not replicate in mammalian cells. The safety of MVA has been well established and accepted by regulatory authorities worldwide, especially among patients with weakened immune systems, as well as among pregnant women.

我們的疫苗採用經過驗證的安全且高效的遞送平台，改良安卡拉痘苗病毒（MVA），它不會在哺乳動物細胞中複製。MVA 的安全性已得到充分證實並得到世界各地監管機構的認可，特別是對於免疫系統較弱的患者以及孕婦。

That our vaccine platform, MVA, is also a standalone vaccine authorized for protection against mpox and smallpox is a unique feature with critically important clinical benefits, providing a significant differentiator for CM04S1, especially as a preferred COVID-19 vaccine in regions endemic to mpox.

我們的疫苗平台MVA 也是一種獨立的疫苗，被授權用於預防MPOX 和天花，這是一個獨特的功能，具有極其重要的臨床益處，為CM04S1 提供了顯著的差異化因素，特別是作為MPOX流行地區的首選COVID-19 疫苗。

A current example is within the Democratic Republic of the Congo, or DRC, where there is a threatening outbreak underway. Also, the CDC recently issued a warning of continued mpox threats and risks within the US We believe that CM04S1 offers an immune profile optimal for more general use as a heterologous booster to current mRNA vaccines, providing a more robust, durable and broadly functional immune response against emerging variants, potentially without the need for the continuous vaccine reconfiguration that appears necessary with the mRNA vaccine.

目前的一個例子是剛果民主共和國境內，那裡正在爆發威脅性的疫情。此外，CDC 最近發布了關於美國境內持續存在的MPOX 威脅和風險的警告。廣泛功能的免疫反應對抗新出現的變異，可能不需要 mRNA 疫苗所需的連續疫苗重新配置。

In fact, the HHS press release announcing our Project NextGen award specifically highlighted our award as providing the potential for a COVID-19 vaccine that provides broader protection, meaning encompassing a wider array of variants and the potential for increased durability than that evidenced by the current authorized vaccines. The clinical data thus far from our current Phase II studies is supportive of this potential.

事實上，宣布我們的NextGen 項目獎項的HHS 新聞稿特別強調了我們的獎項，因為我們的獎項提供了提供更廣泛保護的COVID-19 疫苗的潛力，這意味著涵蓋更廣泛的變體以及比當前疫苗所證明的更強的耐用性的潛力授權疫苗。迄今為止，我們目前的二期研究的臨床數據支持了這種潛力。

Relative to CM04S1, we anticipate partnering and collaborations in additional clinical and research efforts and in support of worldwide commercialization and distribution. Active initiatives are underway in these areas.

相對於 CM04S1，我們預計在額外的臨床和研究工作中合作，並支援全球商業化和分銷。這些領域正在積極採取行動。

As mentioned earlier, we're delighted to be partnered with Allucent for this Phase IIb trial and we recognize the BARDA funding provided to both GeoVax and Allucent to ensure successful operational execution of this critically important study.

如前所述，我們很高興與 Allucent 合作開展這項 IIb 期試驗，並且我們認可 BARDA 向 GeoVax 和 Allucent 提供的資金，以確保這項極其重要的研究的成功實施。

As you recall, 3 Phase II clinical trials are underway with CM04S1, 2 of which address the high-risk populations of immunocompromised patients. The other Phase II trial evaluates our vaccine as a heterologous booster among healthy adults following prior receipt of an mRNA vaccine.

如您所知，CM04S1 的 3 項 II 期臨床試驗正在進行中，其中 2 項針對免疫功能低下患者的高風險族群。另一項 II 期試驗評估我們的疫苗作為健康成年人在先前接受 mRNA 疫苗後的異源加強劑。

Overall, we hope to demonstrate that our COVID-19 vaccine successfully addresses the current unmet needs among the tens of millions of immunocompromised patients while also demonstrating the vaccine as a more robust, durable booster vaccine used in conjunction with mRNA vaccines. I won't delve further into these specific trials at this time but we welcome any questions you may have during our Q&A session.

總體而言，我們希望證明我們的 COVID-19 疫苗成功解決了數千萬免疫受損患者當前未滿足的需求，同時也證明該疫苗是與 mRNA 疫苗結合使用的更強大、更持久的加強疫苗。我目前不會進一步深入研究這些特定試驗，但我們歡迎您在問答環節提出任何問題。

With the announcement of our Project NextGen award last month and the progress in our other Phase II clinical studies, our activity related to partnering and collaborations has increased. We believe that CM04S1 represents significant promise as a critically needed and important part of the COVID-19 vaccine armamentarium for public health worldwide. During the remainder of 2024, we anticipate continued expanded discussions and advancing business development negotiations.

隨著上個月宣布我們的 NextGen 計畫獎項以及我們其他 II 期臨床研究的進展，我們與合作和協作相關的活動有所增加。我們相信，CM04S1 作為全球公共衛生領域迫切需要的 COVID-19 疫苗裝備的重要組成部分，具有重大前景。在 2024 年剩餘時間內，我們預計將繼續擴大討論並推動業務發展談判。

In summary, we are focused on addressing opportunities that provide a basis for achieving leadership within differentiated patient areas and commercial markets. Our current clinical stage products, Gedeptin and CM04S1, are focused on patient populations currently underserved or unserved by existing therapies and or vaccines.

總之，我們專注於抓住機遇，為在差異化患者領域和商業市場中實現領導者奠定基礎。我們目前的臨床階段產品 Gedeptin 和 CM04S1 專注於目前現有療法和/或疫苗服務不足或未服務的患者群體。

GEO-MVA, our vaccine candidate against mpox and smallpox, is intended to disrupt the current monopoly in that important area, providing us a leadership as the first US-based supplier of such a vaccine.

GEO-MVA 是我們針對麻疹和天花的候選疫苗，旨在打破這一重要領域目前的壟斷，使我們成為美國第一家此類疫苗供應商的領導地位。

This may also provide GeoVax our initial step into revenue generation due to the significant governmental interest in US-based supply chains versus over-dependence on non-US suppliers. The strong sentiment in favor of such on sourcing initiative remains a major national legislative focus and interest.

由於政府對美國供應鏈的巨大興趣而不是過度依賴非美國供應商，這也可能為 GeoVax 提供創造收入的第一步。支持這種採購措施的強烈情緒仍然是國家立法的主要焦點和興趣。

We're confident that we're on a course that will build significant shareholder and stakeholder value while delivering critically important differentiated products to improve lives worldwide.

我們相信，我們所走的道路將創造顯著的股東和利害關係人價值，同時提供極其重要的差異化產品，以改善全世界的生活。

Finally, we anticipate providing continued 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 need.

最後，我們預計將提供與先進 MVA 製造流程相關的持續更新，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。

Overall, our various lead stage products, Gedeptin, CM04S1 and MVA represent critically important areas of medical needs, largely unserved or underserved by current products and standard of care.

總體而言，我們的各種領先階段產品 Gedeptin、CM04S1 和 MVA 代表了極其重要的醫療需求領域，而目前的產品和護理標準在很大程度上沒有滿足或服務不足。

We're pleased with the consistent encouraging results we're seeing from our clinical studies. Moreover, we believe that expedited paths to registration are feasible for these products.

我們對從臨床研究中看到的一致的令人鼓舞的結果感到高興。此外，我們相信這些產品的快速註冊途徑是可行的。

From a commercial perspective, these product opportunities represent an estimated annual US revenue potential of over $40 billion. I'll underscore that this isn't a sales forecast but rather a reflection of the significance of the need to address these critically important areas of healthcare, both clinically and commercially.

從商業角度來看，這些產品機會代表了美國每年超過 400 億美元的收入潛力。我要強調的是，這不是銷售預測，而是反映了解決這些至關重要的醫療保健領域（無論是臨床還是商業）的必要性的重要性。

Expanding this to a worldwide basis in conjunction with partners and collaborators adds to the confidence we have relative to the outlook for GeoVax, our shareholders and stakeholders.

與合作夥伴和協作者一起將其擴展到全球範圍，增強了我們對 GeoVax、我們的股東和利害關係人的前景的信心。

Now, I'd like to turn the presentation over to Mark Reynolds, GeoVax's Chief Financial Officer, for a review of our recent results of financial status. Mark?

現在，我想將簡報交給 GeoVax 財務長 Mark Reynolds，讓其回顧我們最近的財務狀況結果。標記？

Thank you, David. Starting with our income statement, I'll focus most of my comments on the comparative figures for the six-month period of 2024 versus 2023.

謝謝你，大衛。從我們的損益表開始，我的大部分評論將集中在 2024 年與 2023 年六個月期間的比較數據。

During the quarter ended June 30, we reported $301,000 of revenues associated with the BARDA Project NextGen award.

在截至 6 月 30 日的季度中，我們報告了與 BARDA Project NextGen 獎項相關的 301,000 美元收入。

There were no comparable revenues reported during 2023. This represents our first billing to BARDA under the contract which began on June 12. So there's a little more than half a month worth of billing there. This is a cost reimbursement contract, so future revenues will directly correlate with our billable personnel time and the incremental expenses we incur.

2023 年沒有報告可比較收入。這是我們根據 6 月 12 日開始的合約向 BARDA 開出的第一筆帳單。所以那裡有半個月多一點的帳單。這是一份成本補償合同，因此未來的收入將與我們的計費人員時間和我們產生的增量費用直接相關。

Research and development expenses were $8.7 million during the first six months of 2024 versus $7.5 million in 2023, representing an increase of roughly $1.2 million, or 15%. This year-over-year increase is primarily associated with the cost of conducting our clinical trials, including manufacturing costs for clinical trial materials, as well as some supportive studies.

2024 年前 6 個月的研發費用為 870 萬美元，而 2023 年為 750 萬美元，增加了約 120 萬美元，即 15%。這種同比增長主要與進行臨床試驗的成本有關，包括臨床試驗材料的製造成本以及一些支持性研究。

General administrative expenses were $2.5 million in 2024 versus $2.9 million in 2023, representing a decrease of $400,000 or 13%, mostly associated with lower stock-based compensation expense and a mix of other costs as well.

2024 年一般管理費用為 250 萬美元，而 2023 年為 290 萬美元，減少了 40 萬美元或 13%，主要與股票薪酬費用和其他成本的降低有關。

Other income net was $31,000 in 2024 as compared to $484,000 in 2023, primarily reflecting lower interest income due to lower cash balances invested through money market accounts.

2024 年其他淨收入為 31,000 美元，而 2023 年為 484,000 美元，主要反映了由於透過貨幣市場帳戶投資的現金餘額減少而導致利息收入減少。

So, overall net loss for the first six months of 2024 was approximately $11 million or $4.68 per share versus $10 million in 2023 or $5.66 per share. Again, with the increase and the net loss being driven by the CM04S1 and the cadet and clinical trial activity.

因此，2024 年前六個月的整體淨虧損約為 1,100 萬美元，即每股 4.68 美元，而 2023 年為 1,000 萬美元，即每股 5.66 美元。同樣，增加和淨損失是由 CM04S1 以及學員和臨床試驗活動所驅動的。

Turning now to the balance sheet, our cash balances at June 30 were $1.6 million as compared to $6.5 million at December 31, reflective of $7.6 million used in operating activities, partially offset by $2.7 million in financing transactions together with some buildup in our payables and accrual balances. We also completed an additional raise in July with net proceeds of $2.8 million which is not reflected in the current balance sheet that you see. Our outstanding common shares currently stand at 5.3 million following the recent financials.

現在轉向資產負債表，我們截至6 月30 日的現金餘額為160 萬美元，而截至12 月31 日為650 萬美元，其中760 萬美元用於經營活動，部分被融資交易中的270 萬美元以及我們的應付帳款和應付帳款的累積所抵銷。我們還在 7 月完成了額外融資，淨收益為 280 萬美元，這並未反映在您看到的當前資產負債表中。根據最近的財務數據，我們的流通普通股目前為 530 萬股。

As David mentioned, the BARDA Project NextGen award was the most significant event during the second quarter and it's our top priority going forward in terms of operational focus. But that entire clinical program is fully funded by BARDA through the awards to GeoVax and to Allucent, our CRO partner. The total federal support for this program will total, we expect, between $367 million and $388 million over the next several years.

正如 David 所提到的，BARDA 下一代專案獎是第二季最重要的事件，也是我們未來營運重點的首要任務。但整個臨床計畫由 BARDA 透過授予 GeoVax 和我們的 CRO 合作夥伴 Allucent 的獎項全額資助。我們預計，未來幾年聯邦政府對該計畫的支持總額將在 3.67 億至 3.88 億美元之間。

In terms of our funding needs, the ongoing non- BARDA Phase II clinical programs for Gedeptin and CM04S1 will continue to be the most significant use of our cash in the foreseeable future. We are currently developing our capital formation plans to fund these programs through the next several valuation and collection points.

就我們的資金需求而言，在可預見的未來，正在進行的 Gedeptin 和 CM04S1 的非 BARDA II 期臨床項目將繼續是我們現金的最重要用途。我們目前正在製定資本形成計劃，透過接下來的幾個評估和收集點為這些計劃提供資金。

I'll be happy to answer any questions during the Q&A period and I'll now turn the call back over to David.

我很樂意在問答期間回答任何問題，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 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。參加我們問答環節的有 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 instructions on the question-and-answer period. Thank you.

我現在將把電話轉給接線員，以獲取有關問答階段的說明。謝謝。

(Operator Instructions)

（操作員說明）

Robert LeBoyer with NOBLE Capital Market.

NOBLE Capital Market 的 Robert LeBoyer。

Good afternoon, and And congratulations on all the great progress in the first half of the year. One of the things that was mentioned was that the cadet in trial is in squamous cell carcinoma of the head and neck and there was a mention of a variety of solid tumors. So I was wondering if there was anything else that you could tell us on any additional indications in preclinical or planned IND filings there?

下午好，祝賀上半年的巨大進展。其中提到的一件事是，試驗中的學員患有頭頸部鱗狀細胞癌，並且提到了多種實體瘤。所以我想知道您是否可以告訴我們關於臨床前或計劃的 IND 申請中的任何其他跡象？

Thank you, Robert. I hope people can hear me. I've been out of the conference call for quite a while but anyway, I'm going to ask Kelly McKee, our Chief Medical Officer, to address that. Kelly?

謝謝你，羅伯特。我希望人們能聽到我的聲音。我已經有一段時間沒有參加電話會議了，但無論如何，我要請我們的首席醫療官凱莉·麥基解決這個問題。凱莉？

Robert, can you hear me okay?

羅伯特，你聽得到我說話嗎？

Yes, I was having some technical difficulties a little earlier but you're loud and clear right now.

是的，我早些時候遇到了一些技術困難，但你現在聲音響亮且清晰。

Okay, because I missed over two-third of this, so I guess Kelly is over there, some -- still some technical difficulties. Well, we initially were studying the advanced head and neck cancer. We did that with the Phase I and then the Phase Ia, IIb. And then we had this -- our review with our clinical advisory committee at the end of April.

好吧，因為我錯過了三分之二以上的內容，所以我猜凱利就在那裡，有些——仍然有一些技術困難。嗯，我們最初研究的是晚期頭頸癌。我們在第一階段做到了這一點，然後是第一階段、第二階段。然後我們在四月底與臨床諮詢委員會進行了審查。

And we've determined that the next target for the Phase II study will be the study approximately, it will be decided as we go through and finalize the protocol but approximately 36 patients. It'll be Gedeptin in combination with the immune checkpoint inhibitor and it will target those with first recurrent head and neck cancer.

我們已經確定 II 期研究的下一個目標將是大約 36 名患者的研究，這將在我們完成並最終確定方案時決定。它將是 Gedeptin 與免疫檢查點抑制劑的組合，它將針對那些首次復發的頭頸癌患者。

Now, we also have been receiving proposals or interest that we also look at triple-negative breast cancer and we also look at earlier stage cancers now. Right now, our focus is not on any of those others, it really is towards advancing with the Phase II trial as we recently announced. I think it was last week we announced what the plans are for that. But we do anticipate that the Gedeptin technology, the therapy, will be applicable to a variety of solid tumors as long as, again, as long as they're needle accessible which is virtually all of today's technology. So we have quite a bit of interest both internally as well as among our oncology advisors.

現在，我們也一直收到建議或興趣，要求我們也研究三陰性乳癌，我們現在也研究早期癌症。目前，我們的重點不是其他任何一個，而是正如我們最近宣布的那樣，推進第二階段試驗。我認為上週我們宣布了相關計劃。但我們確實預期 Gedeptin 技術（即療法）將適用於各種實體瘤，只要它們可以透過針頭進入，這幾乎是當今所有技術的特徵。因此，我們內部以及腫瘤學顧問都對我們非常感興趣。

But right now, we're focused on moving forward with all the planning activities that we've already initiated, the manufacturing, the development of protocols, so that we'll be prepared as we get towards the end of that sort of late second, maybe the beginning of the third quarter next year to activate this Phase II trial.

但現在，我們的重點是推進我們已經啟動的所有規劃活動、製造、協議的開發，以便我們在接近尾聲時做好準備，也許明年第三季初就可以啟動這個二期試驗。

Does that answer your questions well enough?

這足以回答您的問題嗎？

Yes. That was that was a great answer, gave me some of the details I was hoping for. And if I could just ask a second question. Is it too early to ask if the accounting or the funding from NextGen the $24 million has been determined yet? Or any hint as to what the accounting treatment is going to be on those?

是的。那是一個很好的答案，給了我一些我所希望的細節。如果我可以問第二個問題。現在問 NextGen 的 2400 萬美元的帳目或資金是否已經確定是否還為時過早？或者有什麼關於這些的會計處理的暗示嗎？

Mark, you are okay, go ahead.

馬克，你沒事吧，繼續。

Yes, I'll answer that. We're treating this as revenue. It's a cost reimbursement program. So as we expend the external cost for the study and as we incur the personnel time, we bill BARDA for that with a slight mark-up for fringe benefits and for some overhead rates. So as the costs are incurred is when the revenue is recognized. So for the 10-Q that we just filed, the project didn't start until June 12.

是的，我會回答這個問題。我們將其視為收入。這是一個成本補償計劃。因此，當我們花費研究的外部成本以及我們產生的人員時間時，我們會向 BARDA 收取費用，並在附加福利和一些間接費用方面略有加價。因此，成本的發生就是收入的確認。因此，對於我們剛提交的 10-Q，該專案直到 6 月 12 日才開始。

And so we billed a small amount for the month of June. I think we reported $301,000 in the income statement but that will be billed overtime. But the big value here is in the money that's going to the CRO. And that does not flow through our financial statements at all. The money goes directly to the CRO. So you won't see that reflected in our revenues.

因此，我們在 6 月收取了少量費用。我認為我們在損益表中報告了 301,000 美元，但這將按加班費計算。但這裡最大的價值在於為 CRO 提供的資金。這根本不反映在我們的財務報表中。這筆錢直接流向 CRO。所以你不會看到這反映在我們的收入上。

Yes, of course, okay. Thank you very much.

是的，當然，好吧。非常感謝。

So, Mark. Thank you.

那麼，馬克。謝謝。

Jason Kolbert with EF Hutton.

Jason Kolbert 與 EF Hutton。

David, you're right. You cut out about, I would estimate, about a one-third of the way through. So we kind of missed everything you were saying. And I did want to hear you discuss kind of the financials in terms of what the pro forma cash is today and understand how you're going to manage the cash burn going forward. And I understand. BARDA really has nothing to do with this, right? BARDA is just kind of a pass-through on the income statement.

大衛，你是對的。我估計，你刪掉了大約三分之一的內容。所以我們有點想念你所說的一切。我確實想聽你討論一下今天的預計現金是什麼的財務狀況，並了解你將如何管理未來的現金消耗。我明白了。BARDA確實與此無關，對嗎？BARDA 只是損益表的一種傳遞。

Mark, do you want to?

馬克，你願意嗎？

Yes, Jason, I'll address that. In fact, I don't know if the web's live stream is still available or not but I flipped back in the slides to kind of cover some of this. I mean, we did have some across-the-board technical difficulties here where the stream just went down for some reason. So anyway, as I just answered with Robert, for the quarter, we reported $300,000 in revenues from the BARDA contract. And as I said, the money will start flowing. In fact, for the month of July.

是的，傑森，我會解決這個問題。事實上，我不知道網路直播是否仍然可用，但我翻回幻燈片以介紹其中的一些內容。我的意思是，我們確實遇到了一些全面的技術困難，流由於某種原因而中斷。無論如何，正如我剛剛回答 Robert 的那樣，我們報告了本季來自 BARDA 合約的收入 30 萬美元。正如我所說，資金將開始流動。事實上，對於七月來說。

Well, the bottom line is that even with the BARDA funding, we're going to need to raise money, okay? That's a given, because the BARDA contract obviously doesn't cover the other programs we've got ongoing, the other clinical trials for CM04S1 and the planned Gedeptin trial and plus our ongoing corporate overhead and burn.

好吧，最重要的是，即使有了 BARDA 的資金，我們也需要籌集資金，好嗎？這是理所當然的，因為 BARDA 合約顯然不包括我們正在進行的其他項目、CM04S1 的其他臨床試驗和計劃中的 Gedeptin 試驗，以及我們正在進行的公司管理費用和燒錢。

So we will be raising funds. We're not at liberty yet to say how or how much and the timing of all that. That's in development. We are in discussions with several different bankers in that regard. But what I can say is that by BARDA funding a complete clinical pathway for at least one significant program for CM04S1, that gives them flexibility to turn the spigot on and off, so to speak, on some of the other programs.

所以我們將籌集資金。我們還不能自由地透露這一切的方式、程度和時間。那是在開發中。我們正在與幾位不同的銀行家就此進行討論。但我能說的是，透過 BARDA 資助至少一個 CM04S1 重要計畫的完整臨床路徑，這使他們能夠靈活地打開和關閉其他一些計畫的龍頭。

Now we want to accelerate as fast as we can, obviously but that's going to be dependent on the availability of capital resources and the fundraising efforts. And that's still to be determined.

顯然，現在我們希望盡可能快地加速，但這將取決於資本資源的可用性和籌款工作。這還有待確定。

Well, the bottom line is that even with the BARDA funding, we're going to need to raise money, okay? That's a given, because the BARDA contract obviously doesn't cover the other programs we've got ongoing, the other clinical trials for CM04S1 and the planned Gedeptin trial and plus our ongoing corporate overhead and burn.

好吧，最重要的是，即使有了 BARDA 的資金，我們也需要籌集資金，好嗎？這是理所當然的，因為 BARDA 合約顯然不包括我們正在進行的其他項目、CM04S1 的其他臨床試驗和計劃中的 Gedeptin 試驗，以及我們正在進行的公司管理費用和燒錢。

So we will be raising funds. We're not at liberty yet to say how or how much and the timing of all that. That's in development. We are in discussions with several different bankers in that regard. But what I can say is that by BARDA funding a complete clinical pathway for at least one significant program for CM04S1, that gives them flexibility to turn the spigot on and off, so to speak, on some of the other programs.

所以我們將籌集資金。我們還不能自由地透露這一切的方式、程度和時間。那是在開發中。我們正在與幾位不同的銀行家就此進行討論。但我能說的是，透過 BARDA 資助至少一個 CM04S1 重要計畫的完整臨床路徑，這使他們能夠靈活地打開和關閉其他一些計畫的龍頭。

Now we want to accelerate as fast as we can, obviously but that's going to be dependent on the availability of capital resources and the fundraising efforts. And that's still to be determined.

顯然，現在我們希望盡可能快地加速，但這將取決於資本資源的可用性和籌款工作。這還有待確定。

But Mark, where I was really going was, what is the impact of the BARDA award in terms of your flexibility of fundraising instruments? We all know you can raise equity, right? But I'm still wondering if there might be a more or a less dilutive approach. Have you considered debt?

但是馬克，我真正想說的是，BARDA 獎對你們募款工具的靈活性有何影響？我們都知道你可以籌到股本，對嗎？但我仍然想知道是否可能有一種或多或少的稀釋方法。你考慮過債務嗎？

I noticed one of my other companies who was dealing with a depressed stock price actually did something really smart. They did a debt offering and I'm not a big fan of that, except that you have such a securitized asset with BARDA that I would think you -- it would open up some new financial levers for you. That's what I was.

我注意到我的另一家公司在股價低迷的情況下實際上做了一些非常聰明的事情。他們發行了債券，我對此不太感興趣，除了你在 BARDA 擁有這樣的證券化資產，我認為你會為你打開一些新的金融槓桿。我就是這樣。

Well, yes, okay, I understand now. The issue I have with debt is -- and I'm not opposed to debt in the right circumstances. The issue we have with taking on debt for where we are now is that you mentioned the word securitized.

嗯，是的，好吧，我現在明白了。我對債務的看法是──而且我並不反對在適當的情況下債務。我們目前面臨的債務問題是您提到了「證券化」這個詞。

Okay, that's one form -- one way to get some debt done is securitizing asset. But then that hamstrings you -- sometimes with strategic opportunities for corporate licensing and whatever, if you have some lien on your assets or your patents.

好吧，這是一種形式——償還債務的一種方法是將資產證券化。但如果你對你的資產或專利有一些留置權，這就會限制你——有時會帶來公司許可等策略機會。

And outside of that, if you're looking at unsecured debt, then you're -- where we are, you're looking at usually a convertible feature that's built in there. And I'm really not a fan of those.

除此之外，如果您正在考慮無擔保債務，那麼您通常會考慮內建的可轉換功能。我真的不喜歡這些。

But you don't feel -- do you feel comfortable with the kind of offers you're getting that you'll be able to continue to develop, adapt and in terms of the timeline you've already represented in

但你不覺得──你對你得到的那種你能夠繼續發展、適應的工作機會感到滿意嗎？

Yes. Absolutely. I mean, I think that there's still a communication challenge we have to really communicate the value of the assets we've got that is not being reflected in the stock price. And the current environment we're under and the crapper that the market is in right now just compounds that. But I think we're going to weather through it. We will find the funds to continue the programs. And I think there's a lot of upside here.

是的。絕對地。我的意思是，我認為仍然存在溝通挑戰，我們必須真正傳達我們所擁有的資產的價值，而這些資產並沒有反映在股價中。而我們目前所處的環境以及市場目前所處的糟糕狀況只會加劇這種情況。但我想我們會渡過難關的。我們將找到資金來繼續該計劃。我認為這裡有很多好處。

All right. Thanks, guys. I really appreciate it.

好的。謝謝，夥計們。我真的很感激。

Thank you, Dave.

謝謝你，戴夫。

Jeff Kraws with Crystal Research.

水晶研究公司的傑夫·克勞斯。

Thank you very much. And sorry you had your technical difficulties on the call. The questions that basically have been asked that I was going to ask, although I will say I concur with your thoughts on the financial aspects and not using debt because I think that does limit your ability to do many things. On the CM04S1 and the development, given that it does allow you to throttle back on the cash or move forward on the cash when you do, do your raise with your other programs, what is the anticipated speed that you think that product will complete its enrollment?

非常感謝。很抱歉您在通話中遇到了技術困難。這些問題基本上是我要問的，儘管我會說我同意你對財務方面的想法，並且不使用債務，因為我認為這確實限制了你做很多事情的能力。關於 CM04S1 和開發，鑑於它確實允許您減少現金或在您與其他程序一起籌集資金時向前推進現金，您認為該產品完成其預期的速度是多少？

And what is the timing do you think that those trials will conclude? And is there a lot of competition to attract those patients? Obviously, with Gedeptin, you have an easier time recruiting but just wanted to hear your thoughts on recruitment with this. And it's great that obviously it's funded but I wanted to hear your time on that also.

您認為這些試驗何時結束？是否有很多競爭來吸引這些患者？顯然，有了 Gedeptin，您可以更輕鬆地進行招聘，但只是想聽聽您對此的招聘想法。很高興它顯然得到了資助，但我也想聽聽你對此的看法。

Sure.

當然。

Kelly, are you own? Would you like to address that?

凱莉，你是自己的嗎？您想解決這個問題嗎？

Yes, I finally got back on. Sorry about that. Yes, so to talk about the recruitment -- so with the ongoing trial that we have in patients with blood cancers that have received cell transplants, we have two -three sites currently active, two of which have been enrolling fairly briskly. Now, briskly, you have to put that into context.

是的，我終於又回來了。對此感到抱歉。是的，說到招募——隨著我們對接受細胞移植的血癌患者正在進行的試驗，我們目前有兩三個活躍的站點，其中兩個的招募速度相當快。現在，您必須快速地將其置於上下文中。

But we've they've been enrolling over several a couple of patients a month which is pretty much what we projected them to do. And we're planning to activate two additional sites here in the state. And that trial we intend to continue probably for the next year while we are preparing to launch sort of a follow-on study which will be an international trial that will involve sites in the US Canada and the UK.

但我們每個月都會招募幾名患者，這幾乎就是我們預期的。我們計劃在該州另外啟動兩個站點。我們打算可能在明年繼續這項試驗，同時我們準備啟動一項後續研究，這將是一項涉及美國、加拿大和英國站點的國際試驗。

The UK we've been in serious discussions with about this follow-on trial and they're very, very enthusiastic about enrolling patients. We've had discussions with patient groups over there who have -- are clamoring for the opportunity to participate in that trial. So with regard to sort of projected recruitment challenges, I think they're going to diminish over time as we sort of mature the current trial and get the role into the next trial within the next year or two.

我們一直在與英國就這項後續試驗進行認真的討論，他們非常非常熱衷於招募病患。我們已經與那裡的患者團體進行了討論，他們強烈要求有機會參加該試驗。因此，關於預計的招募挑戰，我認為隨著我們目前試驗的成熟並在未來一兩年內將該職位納入下一次試驗，這些挑戰將隨著時間的推移而減少。

So thank you.

所以謝謝你。

And Jeff, this is David. Let me just add, relative to the project NextGen, there are five vaccines that have been provided Project NextGen award. Each one is going to conduct 10,000-patient trial and there's estimated 100 sites in each trial. So there's a lot of competition out there for patients.

傑夫，這是大衛。我補充一下，相對於NextGen項目，有五種疫苗獲得了Project NextGen獎。每個試驗將進行 10,000 名患者的試驗，每個試驗估計有 100 個地點。因此，對於患者來說，競爭非常激烈。

But they're healthy adults, so we think that will go well. We're thrilled at how fast this is moving for us on our behalf. We made the announcement on June the 18 and here we are, what, a month and a half past. And of the 100 sites, there's currently 80 confirmed sites that have already been identified and signed on to this. And others, there are additional ones but they just haven't completed the confirmation process.

但他們都是健康的成年人，所以我們認為一切都會順利。我們對這一切以我們的名義發展得如此之快感到興奮。我們在 6 月 18 日宣布了這一消息，現在已經過去一個半月了。在這 100 個站點中，目前有 80 個已確認的站點已被識別並簽署。還有一些，還有其他的，但他們只是還沒完成確認過程。

So we see, from what I understand, that the Allucent, Kelly and others are, is that we're anticipating that it'll -- enrollment will take about six months which is pretty fast, to say the least, of that. And we're following for, I think it's for a year, whatever it is. But basically, this will go very nicely and we're off to an incredibly fast, successful start of this program. I could not be more thrilled and delighted at the pace that things are going. So that's where it is and that may help you understand it also.

因此，據我了解，Allucent、Kelly 和其他人預計註冊將需要大約六個月的時間，至少可以說，這相當快。我們會跟踪，我想是一年，無論是什麼。但基本上，這將會非常順利，我們將以令人難以置信的速度、成功地開始這個計劃。我對事情進展的速度感到非常興奮和高興。這就是它所在的位置，這也可以幫助您理解它。

Thank you very much, David.

非常感謝你，大衛。

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

我們的問答環節到此結束。我想將會議轉回給大衛·多德（David Dodd）發表閉幕詞。

Okay, thank you. Thank you everyone for participating in today's update, reviewing our progress, our achievements and our outlook. We believe that this past quarter Q2 represented a watershed in the GeoVax development as a result of the Project NextGen award and our decision to proceed with an expanded Gedeptin Phase II clinical trial. Your interest is greatly appreciated and we look forward to ongoing interactions.

好的，謝謝。感謝大家參與今天的更新，回顧我們的進展、我們的成就和我們的展望。我們相信，由於獲得了 Project NextGen 獎項以及我們決定繼續擴大 Gedeptin II 期臨床試驗，上個季度的第二季度代表了 GeoVax 開發的分水嶺。非常感謝您的關注，我們期待持續的互動。

As always, we want to acknowledge and thank our Board of Directors and advisors, our GeoVax staff and the many other parties, entities that continue to support us towards achieving success. We're also committed to providing meaningful career development opportunities for highly competitive, quality-oriented individuals seeking to disrupt the current paradigm of cancer therapy and infectious disease vaccine developments. We're most proud and appreciative of our team, including those external partners who continue to contribute to the progress and success underway at GeoVax.

一如既往，我們要感謝我們的董事會和顧問、GeoVax 員工以及繼續支持我們成功的許多其他各方、實體。我們也致力於為具有高度競爭力、以品質為導向、尋求顛覆當前癌症治療和傳染病疫苗開發模式的個人提供有意義的職業發展機會。我們對我們的團隊感到非常自豪和感激，包括那些繼續為 GeoVax 的進步和成功做出貢獻的外部合作夥伴。

For all of us, it's a great pleasure serving our shareholders and being part of this team. Our overriding goal is to improve lives worldwide by our development and commercialization of novel, critically needed cancer therapies and infectious disease vaccines.

對於我們所有人來說，為我們的股東服務並成為這個團隊的一員感到非常高興。我們的首要目標是透過開發和商業化急需的新型癌症療法和傳染病疫苗來改善全世界的生活。

Have a safe and enjoyable day. Thank you.

度過安全愉快的一天。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。