GeoVax Labs Inc (GOVX) 2024 Q1 法說會逐字稿

Good afternoon, and welcome everyone to the GeoVax first-quarter 2024 corporate update call. My name is Mark, and I will facilitate today's call.

下午好，歡迎大家參加 GeoVax 2024 年第一季公司更新電話會議。我叫馬克，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)；財務長 Mark Reynolds、首席科學官 Mark Newman 博士、首席醫療官 Kelly McKee 醫學博士、公共衛生碩士和業務開發副總裁 John Sharkey 博士。（操作員指示）謹此提醒，本次會議正在錄製中。

At this time, I am turning the call over to Max Gadicke of Stern IR.

目前，我正在將電話轉給 Stern IR 的 Max Gadicke。

Thank you. Please note the following. Certain statements in this presentation constitute forward-looking statements within the meaning of the Private Securities Litigation Reform Act. These statements are based on management's current expectations and are subject to uncertainty and changes in circumstances. Actual results may differ materially from those included in these statements due to a variety of factors, including whether.

謝謝。請注意以下事項。本簡報中的某些陳述構成《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。由於多種因素（包括是否存在），實際結果可能與這些聲明中包含的結果有重大差異。

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 necessaries 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.

GeoVax 可以及時開發和製造具有所需特性的候選產品，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'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 中風險因素中列出的資訊。

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。

Thank you, Max. Good afternoon, and thank you for participating in the first quarter 2024 GeoVax corporate update call. During the first quarter, we successfully advanced our developments focused on our two Phase 2 status products, Gedeptin, a unique therapy against solid tumors, and GEO-CM04S1, a next-generation COVID-19 vaccine. In addition, we also advanced other critically important initiatives. Today, we'll discuss the progress, status and plans related to Gedeptin and CM04S1.

謝謝你，麥克斯。下午好，感謝您參加 2024 年第一季 GeoVax 公司更新電話會議。在第一季度，我們成功推進了我們的開發，重點是兩個 2 期狀態產品：Gedeptin（一種針對實體瘤的獨特療法）和 GEO-CM04S1（一種下一代 COVID-19 疫苗）。此外，我們也推動了其他至關重要的措施。今天，我們將討論Gedeptin和CM04S1的相關進展、現狀和計劃。

Our goal is to develop innovative cancer therapies and infectious disease vaccines 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，尋求支持加快註冊途徑的初步適應症。我們期望建立業務合作夥伴關係和協作，以支援全球開發、商業化和分銷。

Following my comments, Mark Reynolds, our CFO, will provide an update of our financials and then your questions will be addressed.

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。

At year-end, we announced the closure of enrollment for the Phase 1/2 trial of Gedeptin among advanced head and neck cancer patients. This initial targeted patient population represents those who are in end-stage care; the 17,000 in the US and over 400,000 worldwide, who unfortunately die each year as a result of head and neck cancer. Our goal is to obtain clinical evidence supporting advancement of this therapy, including in patients with earlier-stage disease.

年底，我們宣布停止針對晚期頭頸癌患者進行 Gedeptin 1/2 期試驗的招募。這個最初的目標患者群體代表那些處於末期照護的患者；美國每年有 17,000 人以及全世界超過 40 萬人不幸死於頭頸癌。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'll recall this trial was funded by the FDA under the Orphan Drugs Clinical Trials Program. We expect to report the trial final results during this first half of 2024, followed by discussing our plans for further evaluation of Gedeptin in patients with head and neck cancer, including a role similar to neoadjuvant or cytoreductive radiotherapy in combination with checkpoint blockade medications.

您可能還記得這項試驗是由 FDA 孤兒藥臨床試驗計畫資助的。我們預計在 2024 年上半年報告試驗的最終結果，然後討論我們對頭頸癌患者進一步評估 Gedeptin 的計劃，包括與檢查點阻斷藥物相結合的新輔助或細胞減滅放療類似的作用。

We refer to Gedeptin as tumor agnostic, meaning that its 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, in some of which we will present Gedeptin clinical data, with others to conduct partnering discussions.

我們將 Gedeptin 稱為腫瘤不可知論，這意味著它的作用機制將使我們能夠治療各種實體瘤，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，我們正在參加各種腫瘤學和合作會議，在其中一些會議中我們將展示 Gedeptin 臨床數據，並與其他會議進行合作討論。

We recently convened our oncology advisors reviewing the clinical results to-date as well as further opportunities related to Gedeptin and other monotherapy indications. Also addressed were combination therapy indications, Gedeptin in conjunction with immune checkpoint inhibitors. We continue to anticipate discussions with the FDA related to a potential expedited path to registration.

我們最近召集了腫瘤學顧問，審查了迄今為止的臨床結果以及與 Gedeptin 和其他單一療法適應症相關的進一步機會。也討論了聯合治療適應症，Gedeptin 與免疫檢查點抑制劑聯合使用。我們繼續預計與 FDA 就潛在的快速註冊途徑進行討論。

CM04S1, our next-generation COVID-19 vaccine, aims to provide a more practical public health friendly vaccine solution and that offered from the currently approved 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. This is the key differentiation of our vaccine and the current authorized vaccines.

CM04S1是我們的下一代COVID-19疫苗，旨在提供一種更實用的公共衛生友善疫苗解決方案，與目前批准的疫苗提供的解決方案相同。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。這是我們的疫苗與目前授權疫苗的關鍵差異。

Our vaccine utilizes a proven, safe and efficient delivery platform, Modified Vaccinia Ankara, or MVA, which does not replicate in mammalian cells. This distinction is critically important in addressing the high-risk populations of immune-compromised individuals, for whom the current vaccines and monoclonal antibody therapies focused only on blocking or reducing virus infection are often inadequate. 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 differentiation for CM04S1.

我們的疫苗採用經過驗證、安全且高效的遞送平台，改良安卡拉痘苗病毒（MVA），該平台不會在哺乳動物細胞中複製。這種區別對於解決免疫受損個體的高風險族群至關重要，目前僅專注於阻止或減少病毒感染的疫苗和單株抗體療法往往不足以滿足這些族群的需求。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。

In addition, 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 vaccines.

此外，我們相信CM04S1 提供了一種最適合更廣泛用途的免疫特徵，作為當前mRNA 疫苗的異源加強劑，針對新出現的變異提供更強大、持久和廣泛的功能性免疫反應，可能不需要連續的疫苗重新配置。

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. Let me now address our various clinical trials underway with this promising product.

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。現在讓我談談我們正在對這種有前途的產品進行的各種臨床試驗。

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

CM04S1 的三項 2 期臨床試驗正在進行中，其中兩項針對免疫功能低下患者的高風險族群。另一項 2 期試驗評估了我們的疫苗在健康成年人中在先前接受 mRNA 疫苗後作為異源加強疫苗的作用。

Overall, we hope to demonstrate that our COVID-19 vaccine successfully addresses the current unmet needs among the millions of immunocompromised patients while also demonstrating the vaccine is a more robust durable booster vaccine when used in conjunction with mRNA vaccines.

總體而言，我們希望證明我們的COVID-19 疫苗成功解決了數百萬免疫功能低下患者當前未滿足的需求，同時也證明該疫苗與mRNA 疫苗結合使用時是一種更強大、持久的加強疫苗。

Starting with our healthy adult booster trial, last September, we completed enrollment in this trial. The trial involves 63 healthy adults who had previously received the Pfizer/Moderna mRNA vaccine. The immunological responses measured throughout the year-long study provide both neutralizing antibodies against multiple SARS-CoV-2 variants and specific T-cell responses.

去年九月，我們從健康成人加強試驗開始，完成了該試驗的註冊。該試驗涉及 63 名先前接種過輝瑞/Moderna mRNA 疫苗的健康成年人。在長達一年的研究中測量的免疫反應提供了多種 SARS-CoV-2 變異體的中和抗體和特異性 T 細胞反應。

This past February, we reported positive interim data from this trial, indicating no serious adverse events and statistically significant increases in neutralizing antibodies against multiple SARS-CoV-2 variants, ranging from the original Wuhan strain through Delta and Omicron XBB 1.5, as well as robust cellular immune responses. We plan to perform additional testing against the current JN.1 variant. Final results from this heterologous booster trial are anticipated during fourth quarter of this year, reflecting the 12-month monitoring of these patients.

今年2 月，我們報告了該試驗的積極中期數據，表明沒有嚴重的不良事件，並且針對多種SARS-CoV-2 變體的中和抗體有統計顯著增加，從最初的武漢毒株到Delta和Omicron XBB 1.5，以及強大的細胞免疫反應。我們計劃對目前的 JN.1 變體進行額外的測試。這項異源加強試驗的最終結果預計將於今年第四季度公佈，反映了對這些患者為期 12 個月的監測。

In the US, there are approximately 20 million, 25 million immune-compromised adults. Worldwide, there are an estimated 250 million-plus. Such populations include those with various blood cancers, renal disease, autoimmune diseases such as lupus, transplant patients and others with disease or therapy-induced immunosuppression. Many of these patients are limited in their ability to respond adequately to the approved mRNA vaccines, placing them at significant increased risk of severe COVID-19 infection, hospitalization, and potentially death. This is well documented in the medical literature, highlighting the need of a next-generation vaccine that addresses this critically important medical area.

在美國，大約有 2,000 萬、2,500 萬成年人免疫力低下。全球估計有 2.5 億以上。這些人群包括患有各種血癌、腎臟病、狼瘡等自體免疫疾病的人群、移植患者以及其他患有疾病或治療引起的免疫抑制的人。其中許多患者對已批准的 mRNA 疫苗做出充分反應的能力有限，這使他們面臨嚴重 COVID-19 感染、住院治療和潛在死亡的風險顯著增加。這在醫學文獻中有詳細記錄，強調了需要下一代疫苗來解決這個至關重要的醫學領域。

We believe that CM04S1 is the leading next-generation vaccine in clinical development in support of the needs of immunocompromised patients. Also, we believe that an opportunity for an expedited regulatory path likely exists due to our focus on such high-risk unserved and underserved immunocompromised patient populations.

我們相信 CM04S1 是臨床開發中領先的下一代疫苗，可滿足免疫功能低下患者的需求。此外，我們認為，由於我們關注此類高風險、未得到服務和服務不足的免疫功能低下患者群體，因此可能存在加快監管路徑的機會。

Encouraging data from our Phase 2 stem cell transplant immunocompromised, randomized trial comparing CM04S1 against an mRNA vaccine have been presented at several international conferences. Preliminary results were published last September in the peer reviewed journal Vaccines. The findings demonstrated robust immunogenicity, illustrating the vaccine's ability to strongly induce both antibody and T-cell responses, essential for conferring protection, particularly in immunocompromised individuals.

我們的 2 期幹細胞移植免疫受損隨機試驗的令人鼓舞的數據已在多個國際會議上公佈，該試驗將 CM04S1 與 mRNA 疫苗進行比較。初步結果於去年九月發表在同行評審期刊《疫苗》。研究結果證明了強大的免疫原性，說明該疫苗能夠強烈誘導抗體和 T 細胞反應，這對於提供保護至關重要，特別是在免疫功能低下的個體中。

The Vaccine article also highlighted the unique feature of CM04S1, providing immune responses across a spectrum of viral variants, again from the ancestral Wuhan strain through Delta and the highly virulent Omicron XBB 1.5 variant. We're continuing to expand this study to additional sites. Thus far, the data continue to demonstrate increased robust protective immunity and increased durability. This patient population represents one of the highest at-risk patient populations with severe disease, hospitalization and the risk of death.

疫苗文章也強調了 CM04S1 的獨特功能，可提供跨一系列病毒變體的免疫反應，同樣從祖先的武漢株到 Delta 和高毒力的 Omicron XBB 1.5 變種。我們正在繼續將這項研究擴展到其他地點。到目前為止，數據繼續證明增強的保護免疫力和增強的耐用性。此患者群是重症、住院和死亡風險最高的患者群之一。

Following the initiation of patient enrollment in the chronic lymphocytic leukemia immunocompromised patient trial last August, this investigator-initiated trial has continued to recruit and enroll patients. The trial is designed to evaluate CM04S1 among approximately 80 CLL patients directly comparing it to the Pfizer/BioNTech mRNA vaccine.

繼去年八月開始慢性淋巴球白血病免疫功能低下患者試驗的患者入組後，這項由研究者發起的試驗繼續招募和入組患者。該試驗旨在在大約 80 名 CLL 患者中評估 CM04S1，直接與輝瑞/BioNTech mRNA 疫苗進行比較。

Typically, these patients are unable to generate protective antibody responses following mRNA vaccine due to their underlying hematologic malignancy, placing them at extreme risk of developing clinically severe COVID-19. As a consequence, many of these patients remain homebound more than four years since the pandemic began. We are optimistic the CM04S1 can offer these individuals the protection from this virus that they so desperately need. We anticipate that the required number of patients in support of an interim analysis will soon be reached and that the interim results will be available yet this year.

通常，這些患者由於潛在的血液惡性腫瘤，在 mRNA 疫苗接種後無法產生保護性抗體反應，使他們面臨發展為臨床嚴重的 COVID-19 的極高風險。因此，自大流行開始以來，這些患者中的許多人仍居家隔離四年多。我們樂觀地認為 CM04S1 可以為這些人提供他們迫切需要的對這種病毒的保護。我們預計支持中期分析所需的患者數量很快就會達到，中期結果將於今年公佈。

Finally, I'd like to address Project NextGen. This $5 billion initiative, the follow-on from Operation Warp Speed, is focused on accelerating the clinical development of COVID-19 vaccines with the potential for enhanced breadth of protection against variants and improved durability, being particularly interested in novel vaccine candidates already in clinical trials. CM04S1 is a prime example of the desired next-generation COVID-19 vaccine. We continue to have active advancing negotiations regarding the inclusion of CM04S1 in Project NextGen, and we look forward to further updating you in the near future.

最後，我想談談 NextGen 專案。這項價值50 億美元的計畫是「曲速行動」的後續行動，重點是加速COVID-19 疫苗的臨床開發，有可能增強針對變異的保護廣度並提高耐用性，對已經進入臨床的新型候選疫苗特別感興趣試驗。CM04S1 是所需的下一代 COVID-19 疫苗的典型例子。我們繼續積極推動有關將 CM04S1 納入 Project NextGen 的談判，並期待在不久的將來向您提供進一步的最新消息。

We're addressing opportunities that provide us 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 existing vaccines and/or therapies. GEO-MVA, our vaccine against Mpox and Smallpox is intended to disrupt the current global monopoly in that important area, providing us a leadership position as the first US-based supplier of such a vaccine.

我們正在尋找機會，為我們在不同的患者領域和商業市場中取得領導地位奠定基礎。我們目前的臨床階段產品 Gedeptin 和 CM04S1 專注於目前現有疫苗和/或療法服務不足或未服務的患者群體。GEO-MVA 是我們針對 Mpox 和天花的疫苗，旨在打破當前在這一重要領域的全球壟斷，使我們成為美國第一個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 government interest at US-based supply chains versus overdependence on non US suppliers. The strong sentiment in favor of such own-sourcing initiative remains a major national legislative focus and interest, and we're well aware of it and very much involved in it. 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.

由於政府對美國供應鏈的巨大興趣而不是對非美國供應商的過度依賴，這也可能為 GeoVax 提供創造收入的第一步。支持這種自行採購計劃的強烈情緒仍然是國家立法的主要焦點和興趣，我們很清楚這一點並積極參與其中。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。

During the remainder of this year, we'll continue to report progress and results from our CM04S1 Phase 2 programs. For Gedeptin, we expect to report the final results from the recently completed trial and our plans for the expanded Phase 2 trial.

在今年剩餘時間內，我們將繼續報告 CM04S1 第二階段計畫的進展和結果。對於 Gedeptin，我們預計將報告最近完成的試驗的最終結果以及擴大 2 期試驗的計劃。

We also expect to report further plans regarding next steps related to evaluating Gedeptin as combination therapy used in conjunction with immune checkpoint inhibitors. Relative to our MVA vaccine against Mpox and Smallpox, we anticipate reporting our regulatory path and plans related to advancing that product towards registration.

我們還期望報告有關評估 Gedeptin 作為與免疫檢查點抑制劑聯合使用的聯合療法相關的後續步驟的進一步計劃。相對於我們針對 Mpox 和天花的 MVA 疫苗，我們預計會報告我們的監管路徑以及與推進該產品註冊相關的計劃。

Finally, we anticipate further 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，我們預計與我們先進的 MVA 製造流程相關的進一步更新，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。

To summarize, our various clinical stage products, Gedeptin, CM04S1 and MVA, represent critically important areas of medical needs, largely unserved or underserved by current products and standard of care. We are 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.

總而言之，我們的各種臨床階段產品 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。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 potential commercial perspective, these product opportunities represent an estimated annual US revenue potential of almost $30 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. 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.

從潛在的商業角度來看，這些產品機會代表了美國每年約 300 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。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 and financial status. Mark?

現在，我想將簡報交給 GeoVax 財務長 Mark Reynolds，以回顧我們最近的業績和財務狀況。標記？

I'll begin with a brief review of our income statement. The first thing to comment on is we had no grant revenues or government contracts during the first quarter as we've reported in the past years. However, we are having advanced discussions with BARDA related to Project NextGen, and we are highly encouraged of the status of these negotiations. If an award were to be made through this program, this would be a significant catalyst for fundraising and will become an important component of our financing mix going forward. But I will emphasize that this is a forward-looking statement. There can be no assurance that such an award will actually be made.

我將首先簡要回顧我們的損益表。首先要評論的是，正如我們過去幾年所報告的那樣，我們在第一季沒有贈款收入或政府合約。然而，我們正在與 BARDA 就 NextGen 計畫進行深入討論，我們對這些談判的進展感到非常鼓舞。如果透過該計劃進行獎勵，這將成為籌款的重要催化劑，並將成為我們未來融資組合的重要組成部分。但我要強調的是，這是一份前瞻性聲明。無法保證實際會頒發此類獎項。

Research and development expenses were $4.4 million in the first quarter of ‘24 versus $2.8 million in ‘23, representing an increase of $1.6 million or 57%. The year-over-year increase is primarily associated with the cost of conducting our clinical trials, including manufacturing costs for clinical trial materials currently being used and being used in the future.

2024 年第一季的研發費用為 440 萬美元，而 2023 年第一季的研發費用為 280 萬美元，增加了 160 萬美元，增幅為 57%。年比成長主要與進行臨床試驗的成本有關，包括目前使用和未來使用的臨床試驗材料的製造成本。

General and administrative expenses were $1.5 million in the first quarter of ‘24 and relatively unchanged from the amount reported last year.

2024 年第一季的一般和管理費用為 150 萬美元，與去年報告的金額相比基本上沒有變化。

Interest income was $33,000 in the first quarter of this year compared to $232,000 in ‘23, reflecting lower cash balances invested through our money market accounts.

今年第一季的利息收入為 33,000 美元，而 2023 年第一季的利息收入為 232,000 美元，反映出透過貨幣市場帳戶投資的現金餘額減少。

So, overall, net loss for the first quarter of 2024 was $5.9 million, or $2.47 per share, versus $4 million in 2023, or $2.30 per share, again with the increase primarily being driven by the CM04S1 and Gedeptin clinical trial programs.

因此，總體而言，2024 年第一季的淨虧損為590 萬美元，即每股2.47 美元，而2023 年為400 萬美元，即每股2.30 美元，這一增長主要是由CM04S1 和Gedeptin 臨床試驗項目推動的。

Turning now to the balance sheet. Our cash balances at March 31st were $769,000 as compared to $6.5 million at the end of 2023, reflective of $5.7 million used in operating activities. There were no financing activities in the first quarter, but we do expect to raise capital in the very near future. And I'll also note that, as disclosed in our 10-Q being filed today, our management team and Board recently provided a modest amount of capital to the company through a straight debt structure in order to help bridge to our next capital raise.

現在轉向資產負債表。截至 3 月 31 日，我們的現金餘額為 769,000 美元，而 2023 年底為 650 萬美元，其中 570 萬美元用於經營活動。第一季沒有融資活動，但我們確實預計在不久的將來籌集資金。我還要指出的是，正如我們今天提交的 10-Q 中所披露的那樣，我們的管理團隊和董事會最近通過直接債務結構向公司提供了適量的資本，以幫助我們完成下一次融資。

Our outstanding common shares stand at 2.3 million following the reverse split we exercised at the end of January this year, which brought us -- the intention of that was to bring us back into full compliance with NASDAQ.

今年 1 月底進行反向分割後，我們的已發行普通股達到 230 萬股，此舉的目的是讓我們重新完全遵守納斯達克證券交易所的規定。

Funding our ongoing Phase 2 clinical programs for CM04S1 and Gedeptin will continue to be the most significant use of our cash for the foreseeable future. We don't expect this prioritization of spending to change if we receive a Project NextGen award from BARDA, as any incremental spending for that program will be funded completely by the award.

在可預見的未來，為我們正在進行的 CM04S1 和 Gedeptin 2 期臨床項目提供資金將繼續是我們現金最重要的用途。如果我們獲得 BARDA 頒發的 Project NextGen 獎項，我們預計這種支出優先順序不會改變，因為該計劃的任何增量支出都將完全由該獎項資助。

Now happy to answer any questions during the Q&A, and I'll turn the call back to David.

現在很高興回答問答期間的任何問題，我會將電話轉回給大衛。

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

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馬克紐曼(Mark Newman) 醫生、凱利麥基(Kelly McKee) 醫生和約翰夏基(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。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）

Robert LeBoyer, Noble Capital Markets.

羅伯特·勒博耶，Noble Capital Markets。

Good afternoon. And my first question has to do with Gedeptin. And you mentioned that there would be a data update coming shortly and you had been in consultation with your advisors about the path forward with combinations of checkpoint inhibitors or monotherapy. Were there any other options that you mentioned? There were a few things that I thought I heard, but wasn't exactly certain as to what pathway you were thinking about t

午安.我的第一個問題與 Gedeptin 有關。您提到很快就會有數據更新，並且您一直在與您的顧問就檢查點抑制劑組合或單一療法的前進道路進行協商。您提到的還有其他選擇嗎？我想我聽到了一些事情，但不確定你正在考慮什麼途徑

So, Robert, I'll answer and then I'll ask Dr. McKee to step in. So, we recently met with our advisors, and thank you for your question, first of all, and that was to go through the final results, et cetera, from the trial that was completed at last year-end. The focus that we have going forward initially will be on head and neck cancer, as we've done in that initial trial and looking at it perhaps even an earlier stage. The combination therapy is when Gedeptin will be combined with the immune checkpoint inhibitors, but we will be looking at other monotherapy uses of Gedeptin against standalone solid tumors.

所以，羅伯特，我會回答，然後我會請麥基醫生介入。因此，我們最近會見了我們的顧問，首先感謝您提出的問題，這是從去年年底完成的試驗中得出的最終結果等。我們最初的重點將放在頭頸癌上，正如我們在最初的試驗中所做的那樣，甚至可能在早期階段進行研究。聯合療法是吉德普汀與免疫檢查點抑制劑合併使用，但我們將研究吉德普汀針對獨立實體瘤的其他單一療法用途。

Kelly, would you like to step in now?

凱莉，你現在願意介入嗎？

Well, sure. I mean, I think you sort of hit the nail on the head. Our advisory committee sort of recommended a sort of a next step forward for the head and neck cancer program, sort of by focusing on a target population that they thought would yield more meaningful data in terms of sort of where we would go beyond that in the head and neck cancer treatment population.

嗯，當然。我的意思是，我認為你說得一針見血。我們的諮詢委員會建議頭頸癌計劃採取下一步措施，即重點關注目標人群，他們認為這些目標人群將在我們將在哪些方面超越這一目標方面產生更有意義的數據。

At the same time, we're looking at other solid tumor types. I mean, we've got some discussions underway with a group at Emory that's interested in looking at this in triple-negative breast cancer patients, and we will be speaking with some people at Oxford University next week, in fact, about the potential for a study, so the (inaudible) trial in other solid tumor types. But those discussions are all very early on -- early at this point and probably no details worth sharing it at this time.

同時，我們正在研究其他實體瘤類型。我的意思是，我們正在與埃默里大學的一個小組進行一些討論，該小組有興趣在三陰性乳癌患者中研究這一點，事實上，我們下週將與牛津大學的一些人討論這種方法的潛力一項研究，因此是針對其他實體瘤類型的（聽不清楚）試驗。但這些討論都還處於早期階段，目前可能還沒有值得分享的細節。

Okay. Well, thank you. That's very helpful. I also had a question on the MVA for Smallpox and Monkeypox, and was wondering if there were any details that you could share about the steps or milestones between where you are today and potential revenues down the road?

好的。嗯，謝謝。這非常有幫助。我還有一個關於天花和猴痘 MVA 的問題，想知道您是否可以分享有關您目前的狀況和未來潛在收入之間的步驟或里程碑的任何細節？

Sure. I'll call on John Sharkey to address that. He's leading our MVA program standalone vaccine.

當然。我會請約翰·夏基來解決這個問題。他正在領導我們的 MVA 獨立疫苗計畫。

Hey, Robert. Thanks for the question. So, we continue to progress our MVA. We have begun the process of preparing the (inaudible) with our partner Oxford Biomedica, formerly was ABL in France prior to the merger. We are finalizing the submission to the appropriate regulatory agency. We've not disclosed our regulatory strategies just yet with some additional questions on the process forward.

嘿，羅伯特。謝謝你的提問。因此，我們繼續推進 MVA。我們已經開始與我們的合作夥伴 Oxford Biomedica（合併前的法國 ABL）一起準備（聽不清楚）。我們正在完成向適當監管機構提交的申請。我們尚未披露我們的監管策略，但對後續流程還有一些其他問題。

We remain optimistic there is an accelerated pathway forward for this program, but we have not, at this point, projected any final registration date or anything else. But we continue, as I said, to move efforts forward on both the supply front to have material available for any clinical work we have to do, as well as initial commercial launch supplies, as well as discussions with regulatory authority to finalize any last questions that we have. Hopefully, that helps.

我們仍然樂觀地認為該計劃將加速推進，但目前我們還沒有預期任何最終註冊日期或其他任何內容。但正如我所說，我們繼續在供應方面做出努力，為我們必須做的任何臨床工作提供可用的材料，以及最初的商業發射供應，並與監管機構進行討論以最終確定最後的問題我們有。希望這會有所幫助。

Yes, that does help. Thank you very much.

是的，這確實有幫助。非常感謝。

I'll add on, Robert, that you're probably familiar with there have been major outbreaks of Mpox throughout Africa and even in locations in major cities throughout the United States. So this isn't going away and there's a great interest in US-based supplier, so that we're able to respond in meeting the full global needs and doing that in a rapid time period.

羅伯特，我還要補充一點，您可能很熟悉整個非洲甚至美國主要城市的一些地方都曾爆發過大規模的 Mpox 疫情。因此，這種情況不會消失，而且人們對美國供應商很感興趣，因此我們能夠做出反應，滿足全球的全部需求，並在短時間內做到這一點。

Yes. And as you mentioned, the national stockpile is a definite customer for Smallpox vaccines and other things that can be produced through that method. So thank you.

是的。正如您所提到的，國家庫存是天花疫苗和其他可以透過該方法生產的產品的明確客戶。所以謝謝。

Sure. Thank you.

當然。謝謝。

(Operator Instructions)

（操作員說明）

There are no more questions coming at this time. This concludes our question-and-answer session. I would like to turn the conference back over to David Dodd for any closing remarks.

目前沒有更多問題。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。

Sure. Thank you, everyone, for participating in today's update and sharing in our achievements, progress and outlook. We really appreciate your interest. I want to acknowledge and thank the Board of Directors and Advisors, our GeoVax staff and the many other parties that continue to support us towards achieving success.

當然。感謝大家參與今天的更新並分享我們的成就、進步和展望。我們非常感謝您的關注。我要感謝董事會和顧問、我們的 GeoVax 員工以及繼續支持我們成功的許多其他各方。

Additionally, we're committed to providing meaningful career development opportunities for highly-competitive, quality-oriented individuals seeking to disrupt the current paradigm of cancer therapies and infectious disease vaccines. We are most proud and appreciative of our team, including those external partners who continue to contribute to the progress and success underway at GeoVax.

此外，我們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範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 is 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 dissconnect.

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。