AIM ImmunoTech Inc (AIM) 2024 Q4 法說會逐字稿

Hello and welcome to the AIM ImmunoTech fourth-quarter and full-year 2024 update conference call and webcast. (Operator Instructions) Note that this webcast is being recorded at the company's request, and a replay will be made available on the company's website following the end of the event.

您好，歡迎參加 AIM ImmunoTech 2024 年第四季和全年更新電話會議和網路廣播。（操作員指示）請注意，本次網路直播是應公司要求錄製的，活動結束後將在公司網站上提供重播。

At this time, I'd like to remind our listeners that remarks made during the webcast may state management's intentions, beliefs, expectations, or future projections. These are forward-looking statements and involve risks and uncertainties. Forward-looking statements on this call are made pursuant to the safe harbor provisions of the federal securities laws and are based on AIM ImmunoTech current expectations and actual results could differ materially.

此時，我想提醒我們的聽眾，網路直播中的言論可能表明管理層的意圖、信念、期望或未來預測。這些是前瞻性陳述，涉及風險和不確定性。本次電話會議中的前瞻性聲明是根據聯邦證券法的安全港條款做出的，並基於 AIM ImmunoTech 目前的預期，實際結果可能存在重大差異。

As a result, you should not place undue reliance on any forward-looking statements. Some of the factors that could cause actual results of different materially from these contemplated by such forward-looking statements are discussed in the periodic reports AIM ImmunoTech's files with the Securities and Exchange Commission.

因此，您不應過度依賴任何前瞻性陳述。AIM ImmunoTech 向美國證券交易委員會提交的定期報告中討論了可能導致實際結果與此類前瞻性陳述所預期的結果存在重大差異的一些因素。

These documents are available in the Investor section of the company's website and on the Securities and Exchange Commission's website. We encourage you to view these documents carefully. Additionally, certain information contained in the webcast relates to or is based on studies, publications, surveys and other data obtained from third-party sources of the company's own estimates and research.

這些文件可在公司網站的投資者部分和美國證券交易委員會的網站上找到。我們鼓勵您仔細查看這些文件。此外，網路廣播中包含的某些資訊涉及或基於公司本身的估計和研究，或基於從第三方來源獲得的研究、出版物、調查和其他數據。

While the company believes the third-party sources to be reliable as of the date of this presentation, it has not independently verified and makes no representation as to the adequacy, fairness, accuracy or completeness of or that any independent source has verified any information obtained from third-party sources.

儘管本公司認為截至本簡報發布之日第三方來源是可靠的，但它尚未獨立核實，也不對任何獨立來源已核實從第三方來源獲得的任何資訊的充分性、公平性、準確性或完整性作出任何陳述。

Joining us on today's call from the AIM ImmunoTech leadership team is Thomas Equels, Chief Executive Officer. I'd like to now turn the call over to Mr. Equels. Please proceed.

參加今天 AIM ImmunoTech 領導團隊電話會議的有執行長 Thomas Equels。現在我想把電話轉給艾克爾斯先生。請繼續。

Thank you, operator. I'd like to thank everyone for joining us this morning. I've been looking forward to this call because the progress we've made in the last several months underscores our commitment to advancing Ampligen across multiple areas of significant medical need.

謝謝您，接線生。我要感謝大家今天早上的參加。我一直期待著這次電話會議，因為我們在過去幾個月中取得的進展強調了我們致力於在多個重大醫療需求領域推進 Ampligen 的承諾。

We're continuing to build meaningful momentum, both clinically and strategically, and I'm excited to walk through some of the recent highlights. To start, we recently announced plans to conduct a new clinical study evaluating Ampligen in combination with AstraZeneca's intranasal influenza vaccine FluMist.

我們正在臨床和策略上繼續建立有意義的勢頭，我很高興介紹一些最近的亮點。首先，我們最近宣布計劃進行一項新的臨床研究，以評估 Ampligen 與阿斯特捷利康鼻內流感疫苗 FluMist 的聯合作用。

This study will explore this combination as a potential intranasal vaccine for influenza, including avian flu. We're honored that Dr. Paul Goepfert of the University of Alabama-Birmingham Medical Center will serve as principal investigator for this important study.

這項研究將探討這種組合作為流感（包括禽流感）的潛在鼻內疫苗。我們很榮幸阿拉巴馬大學伯明翰醫學中心的 Paul Goepfert 博士將擔任這項重要研究的首席研究員。

From a corporate standpoint, we further strengthened our leadership with the addition of two Board members, Ted Kellner, who has 50 years of investment experience and was previously a portfolio manager at Fiduciary Management, and David Chemerow, who brings more than 40 years of finance, accounting and operations leadership across multiple industries. Their experience and guidance will be instrumental as we move forward to execute on our strategy.

從公司角度來看，我們透過增加兩位董事會成員進一步加強了我們的領導地位，這兩位董事會成員分別是擁有 50 年投資經驗、曾任 Fiduciary Management 投資組合經理的 Ted Kellner 和擁有 40 多年財務、會計和營運領導經驗的 David Chemerow，涉及多個行業。他們的經驗和指導對於我們實施策略將起到至關重要的作用。

On the clinical front, we're pleased to report that the Erasmus Medical Center Safety Committee has approved the continuation into the Phase 2 portion of the DURIPANC pancreatic cancer trial. This is the ongoing Phase 1b/2 study evaluating Ampligen in combination with AstraZeneca's drug Imfinzi, an anti-PD-L1 checkpoint inhibitor for the treatment of late-stage metastatic pancreatic cancer.

在臨床方面，我們很高興地報告，伊拉斯姆斯醫療中心安全委員會已經批准繼續進行 DURIPANC 胰臟癌試驗的第 2 階段。這是正在進行的 1b/2 期研究，旨在評估 Ampligen 與阿斯特捷利康的藥物 Imfinzi（一種抗 PD-L1 檢查點抑制劑）聯合用於治療晚期轉移性胰腺癌。

Dosing has commenced for the Phase 2 portion of the trial, which is a key step forward in this critical program. We also announced final clinical results from our AMP-518 study, evaluating Ampligen in the treatment of patients with post-COVID conditions.

該試驗的第二階段已開始給藥，這是該關鍵項目向前邁出的關鍵一步。我們也發表了 AMP-518 研究的最終臨床結果，評估了 Ampligen 對 COVID 後遺症患者的治療效果。

This data represents a culmination of our efforts in this space and reinforces our belief and Ampligen's potential to help address the persistent fatigue experienced by so many people post COVID. In parallel, we continue to expand our intellectual property estate. We were recently granted a US patent covering compositions and methods for the treatment of endometriosis as well as a Netherlands patent protecting the use of Ampligen for the post-COVID condition of fatigue.

這些數據代表了我們在這個領域努力的成果，並強化了我們的信念以及 Ampligen 幫助解決許多人在 COVID 後經歷的持續疲勞的潛力。同時，我們繼續擴大我們的知識產權資產。我們最近獲得了一項美國專利，涵蓋治療子宮內膜異位症的組合物和方法，以及一項荷蘭專利，保護使用 Ampligen 治療 COVID 後疲勞症狀。

And lastly, we announced the publication of new data from a Phase 1 study conducted at Roswell Park Comprehensive Cancer Center. This study evaluated Ampligen as part of a combination therapy in early stage triple negative breast cancer, and the data was published in the journal for Immunotherapy of Cancer, further strengthening the clinical foundation and broad-spectrum capabilities and potential of our immuno-oncology programs.

最後，我們宣布發布羅斯威爾帕克綜合癌症中心進行的第一階段研究的新數據。這項研究評估了 Ampligen 作為早期三陰性乳癌聯合療法的一部分的效果，其數據發表在《癌症免疫治療》雜誌上，進一步加強了我們的免疫腫瘤學計畫的臨床基礎和廣譜能力和潛力。

As you can see, we maintained strong momentum and continue to execute across multiple programs. I'm very proud of our team's progress, and I believe this growing body of clinical evidence reinforces Ampligen's broad potential and positions us as a company for the next phase of our journey.

如您所見，我們保持了強勁勢頭並繼續執行多個計劃。我為我們團隊的進步感到非常自豪，我相信越來越多的臨床證據增強了 Ampligen 的廣泛潛力，並使我們公司在下一階段的旅程中佔據了有利地位。

Now I'd like to walk through our pipeline to provide a snapshot of where we stand across each of our active clinical programs as well as highlight some upcoming value-driving milestones that we feel have great potential.

現在，我想介紹我們的產品線，簡要介紹我們在每個活躍臨床項目中的進展情況，並重點介紹一些我們認為具有巨大潛力的即將到來的價值驅動里程碑。

Starting with metastatic pancreatic cancer, the DURIPANC study is a Phase 1b/2 trial evaluating the combination of Ampligen with AstraZeneca's checkpoint inhibitor, durvalumab. This study is being conducted in collaboration with Erasmus Medical Center and is fully funded through that partnership and collaboration agreement entered into with Erasmus Medical Center and AstraZeneca.

DURIPANC 研究從轉移性胰臟癌開始，是一項 1b/2 期試驗，評估 Ampligen 與阿斯特捷利康檢查點抑制劑 durvalumab 的合併用藥。這項研究是與伊拉斯姆斯醫療中心合作進行的，並透過與伊拉斯姆斯醫療中心和阿斯特捷利康達成的合作協議獲得全額資助。

Following the recent start of the Phase 2 dosing, we anticipate enrollment of the final patient in the study during the second or third quarter of 2026.

隨著最近開始第 2 階段給藥，我們預計將於 2026 年第二季或第三季招募最後一位患者參與研究。

In advanced ovarian cancer, we have a Phase 2 study evaluating Ampligen and Pembrolizumab, and it is nearing completion. The study is grant funded by Merck. It's expected to be completed in the first half of 2025 with data anticipated soon thereafter.

在晚期卵巢癌方面，我們進行了一項評估 Ampligen 和 Pembrolizumab 的 2 期研究，目前已接近完成。該研究由默克公司資助。預計該項目將於 2025 年上半年完成，隨後將很快提供數據。

For refractory melanoma, we have a Phase 2 study evaluating a combination regimen that includes Ampligen, Interferon Alpha, Celecoxib and a polarized dendritic cell vaccine in HLA-A2 positive patients. This study is funded by the National Cancer Institute, and we expect the first patient to be dosed in the first half of 2025.

對於難治性黑色素瘤，我們進行了 2 期研究，評估針對 HLA-A2 陽性患者的聯合治療方案，包括 Ampligen、幹擾素 α、塞來昔布和極化樹突狀細胞疫苗。這項研究由美國國家癌症研究所資助，我們預計第一位患者將於 2025 年上半年接受治療。

There is also a phase 1/2a trial in Stage 4 triple negative breast cancer that combines Ampligen with Celecoxib, Interferon Alpha and Pembrolizumab. This program is also grant funded with support from Merck and the National Cancer Institute. Enrollment is underway and the study is expected to complete enrollment in the second quarter of 2026.

此外，還有一項針對第 4 期三陰性乳癌的 1/2a 期試驗，將 Ampligen 與塞來昔布、幹擾素 α 和 Pembrolizumab 結合。該計畫也獲得了默克公司和美國國家癌症研究所的資助。招募工作正在進行中，預計將於 2026 年第二季完成招募。

We also remain committed to advancing Ampligen in long COVID, where we've completed our AMP-518 trial and are actively planning a follow-up study to build on the encouraging data generated today.

我們也將繼續致力於推進 Ampligen 在長期 COVID 中的應用，我們已經完成了 AMP-518 試驗，並正在積極計劃後續研究，以在今天產生的令人鼓舞的數據的基礎上再接再厲。

Additionally, we're preparing a new clinical study, which I mentioned earlier evaluating Ampligen in combination with FluMist as a potential intranasal vaccine for influenza, including avian influenza in collaboration with the University of Alabama-Birmingham.

此外，我們正在準備一項新的臨床研究，我之前提到過，該研究將與阿拉巴馬大學伯明翰分校合作，評估 Ampligen 與 FluMist 的組合作為流感（包括禽流感）的潛在鼻內疫苗。

As you can see, our pipeline continues to advance with multiple programs nearing key inflection points. Each of these programs is targeted to address areas of high unmet medical need, and we believe this continued clinical progress combined with growing external validation and strategic collaboration positions AIM for an exciting year ahead.

如您所見，我們的管道繼續向前推進，多個專案已接近關鍵轉折點。這些項目均旨在解決尚未滿足的醫療需求領域，我們相信，持續的臨床進展，加上不斷增長的外部驗證和策略合作，將使 AIM 迎來令人興奮的一年。

I want to touch briefly now on our financial position. In terms of cash, cash equivalents and marketable securities, and we need to address this based on the last audited numbers, we had $4 million approximately as of December 31, 2024.

現在我想簡單談談我們的財務狀況。就現金、現金等價物和有價證券而言，我們需要根據上次審計的數字來解決這個問題，截至 2024 年 12 月 31 日，我們約有 400 萬美元。

Research and development expenses for the year ended December 31, 2024, were $6.2 million as compared to $10.9 million for the year, which ended on December 31, 2023. And general and administrative expenses for the year ended December 31, 2024, were $13.7 million as compared to $21.1 million for the year ended December 31, 2023.

截至 2024 年 12 月 31 日止年度的研發費用為 620 萬美元，而截至 2023 年 12 月 31 日止年度的研發費用為 1,090 萬美元。截至 2024 年 12 月 31 日止年度的一般及行政費用為 1,370 萬美元，而截至 2023 年 12 月 31 日止年度的一般及行政費用為 2,110 萬美元。

Now, I'd like to take a moment to address our continued listing on the New York Stock Exchange American. Maintaining our listing is a major priority frame and we believe it's essential for our long term success. Being listed on a national exchange provides access to capital, enhances our credibility and visibility in the market, and supports stockholder and partner confidence.

現在，我想花點時間談談我們繼續在紐約證券交易所美國上市的問題。維護我們的清單是我們的主要優先事項，我們相信這對我們的長期成功至關重要。在國家交易所上市可以讓我們獲得資金，提高我們在市場上的信譽和知名度，並增強股東和合作夥伴的信心。

It also helps ensure liquidity for our stockholders, which is a critical consideration as we continue to build momentum across our pipeline. We understand the importance of meeting the exchange listing requirements and are actively evaluating all available options to maintain compliance.

它還有助於確保我們股東的流動性，這是我們繼續在整個管道中建立勢頭的關鍵考慮因素。我們了解滿足交易所上市要求的重要性，並正在積極評估所有可用選項以保持合規性。

This includes a potential reverse stock split among other strategic alternatives. We will be holding a special meeting of stockholders within the next month or so to authorize our Board to affect the reverse stock split at that time and at a ratio that should avoid delisting.

其中包括潛在的反向股票分割等策略性選擇。我們將在下個月左右召開一次特別股東大會，授權董事會在那時以避免退市的比例進行反向股票分割。

We are committed to taking the necessary steps to preserve our listing, and we will continue to act in the best interests of the company and our stockholders as we move forward. Before I turn it over to the operator for questions and answers, I want to take a moment to center on what drives everything we do here at AIM.

我們致力於採取必要措施維持我們的上市地位，並將繼續以公司和股東的最佳利益為出發點。在將問題交給操作員進行回答之前，我想花點時間集中討論一下我們在 AIM 所做的一切的驅動力。

It is our mission, immunology for a better future, and that is more than just a tagline. It reflects our deep belief in the potential of the Ampligen and our commitment to advancing this important asset so it can make a real difference in patients' lives.

我們的使命是，用免疫學創造更美好的未來，這不僅僅是一句口號。它反映了我們對 Ampligen 潛力的堅定信念以及我們致力於推進這一重要資產的承諾，以便它能夠真正改變患者的生活。

With that operator, we're ready to take questions, and thank you very much.

有了那位接線員，我們就可以回答問題了，非常感謝。

(Operator Instructions) Ed Woo, Ascendiant Capital Markets.

（操作員指示）Ed Woo，Ascendiant Capital Markets。

Yeah. Congratulations on all the progress. My question is on your current inventory of Ampligen, do you have adequate supply for all your clinical trials this year and how easy would it be for you to get new supply?

是的。祝賀你取得的所有進展。我的問題是關於您目前的 Ampligen 庫存，您是否有足夠的供應來滿足您今年的所有臨床試驗的需求，以及您獲得新供應的難易程度如何？

Well, thank you, Dr. Woo. We have a Ampligen budget that's tied to our ongoing clinical activity so that we make an effort and certainly our collaborators, especially the research institutes that we work with consider it very important that we budget sufficient Ampligen for the trials that are ongoing.

好的，謝謝你，吳醫師。我們的 Ampligen 預算與我們正在進行的臨床活動掛鉤，以便我們做出努力，當然我們的合作者，特別是與我們合作的研究機構認為，為正在進行的試驗預算足夠的 Ampligen 非常重要。

So I believe absent some unanticipated or extraneous event that there should be no problem supplying the Ampligen for the ongoing clinical trials. For future clinical trials, we will have to manufacture more Ampligen and that requires capital, but the process for manufacturing additional Ampligens being analyzed and the work that we're doing with polymer manufacturers and other vendors that are essential to the manufacturing process is a part of our constant operational activity.

因此我相信，只要不發生一些意外或無關事件，為正在進行的臨床試驗提供 Ampligen 應該不會有問題。對於未來的臨床試驗，我們將必須生產更多的 Ampligen，這需要資金，但生產更多 Ampligen 的過程正在分析中，而我們與聚合物製造商和其他對製造過程至關重要的供應商合作的工作是我們持續營運活動的一部分。

So we don't anticipate a problem of running out of Ampligen absent some unforeseen circumstances.

因此，除非出現一些不可預見的情況，我們預計不會出現 Ampligen 耗盡的問題。

Great. Well, thank you for answering my questions, and I wish you guys good luck. Thank you.

偉大的。好吧，謝謝你回答我的問題，祝你們好運。謝謝。

Thank you. We have reached the end of our question-and-answer session. And with that does bring this call to a close. We appreciate your participation today. You may now disconnect.

謝謝。我們的問答環節已經結束。本次通話至此結束。我們感謝您今天的參與。您現在可以斷開連線。