Aethlon Medical Inc (AEMD) 2024 Q4 法說會逐字稿

完整原文

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  • Operator

    Operator

  • Good day and welcome to the Aethlon Medical fiscal year end of 2024 earnings conference call. All participants will be in a listen-only mode. (Operator Instructions) Please note this event is being recorded. I would now like to turn the conference over to Mr. Michael Miller with Rx Communications. Please go ahead, sir.

    美好的一天,歡迎參加 Aethlon Medical 2024 財政年度終收益電話會議。所有參與者將處於僅聽模式。(操作員說明)請注意此事件正在被記錄。我現在想將會議轉交給 Rx Communications 的 Michael Miller 先生。請繼續,先生。

  • Michael Miller - IR

    Michael Miller - IR

  • Thank you, operator, and good afternoon, everyone. Welcome to Aethlon Medical's Fiscal Year End 2024 earnings conference call. My name is Michael Miller with Rx Communications. At 4:15 PM Eastern Time today, Aethlon Medical released financial results for its fiscal year end March 31, 2024. If you have not seen or received Aethlon Medical's earnings release, please visit the Investors page at www.aehlonmedical.com.

    謝謝接線員,大家下午好。歡迎參加 Aethlon Medical 的 2024 財政年度終收益電話會議。我是 Rx Communications 的 Michael Miller。美國東部時間今天下午 4:15,Aethlon Medical 發布了截至 2024 年 3 月 31 日的財年財務表現。如果您尚未看到或收到 Aethlon Medical 的收益發布,請造訪投資者頁面 www.aehlonmedical.com。

  • Following this introduction and the reading of the company's forward looking statement, Aethlon's Chief Executive Officer and Chief Financial Officer, James Frakes, Aethlon's Chief Medical Officer, Dr. Steven LaRosa will provide an overview of Aethlon's strategy and recent developments. Mr. Frakes will then make some brief remarks on Aethlon financials. We will then open up the call for the Q&A session.

    在介紹並閱讀公司前瞻性聲明後,Aethlon 執行長兼財務長 James Frakes 和 Aethlon 首席醫療官 Steven LaRosa 博士將概述 Aethlon 的策略和近期發展。然後,Frakes 先生將對 Aethlon 的財務狀況發表一些簡短的評論。然後我們將開始問答環節。

  • Before I hand the call over to Mr. Frakes, please note that the news release today and this call contain forward-looking statements within the meaning of the Securities Act of 1933 as amended and the Securities Exchange Act of 1934 as amended. The company cautions you that any statement that is not a statement of historical fact is a forward-looking statement. These statements are based on expectations and assumptions as of the date of this conference call.

    在我將電話轉交弗雷克斯先生之前,請注意今天的新聞稿和本次電話會議包含經修訂的 1933 年證券法和經修訂的 1934 年證券交易法含義內的前瞻性陳述。該公司提醒您,任何不是歷史事實陳述的陳述都是前瞻性陳述。這些陳述是基於截至本次電話會議之日的預期和假設。

  • Such forward-looking statements are subject to significant risks and uncertainties, and actual results may differ materially from the results anticipated in the forward-looking statements. Factors that could cause results to differ materially from those anticipated in forward looking statements can be found under the caption Risk Factors in the company's annual report on Form 10-K for the fiscal year ended March 31, 2024, and the company's most recent quarterly report on Form 10-Q and in the Company's other filings with the Securities and Exchange Commission.

    此類前瞻性陳述存在重大風險和不確定性,實際結果可能與前瞻性陳述中預期的結果有重大差異。可能導致結果與前瞻性陳述中預期的結果有重大差異的因素可以在公司截至2024 年3 月31 日的財年10-K 表格年度報告以及公司最近的季度報告中的“風險因素”標題下找到。

  • Except as may be required by law, the company does not intend nor does it undertake any duty to update this information to reflect future events or circumstance. With that I'll now turn the call over to Mr. James Frakes , Aethlon's Interim Chief Executive Officer, and Chief Financial Officer.

    除法律要求外,本公司不打算也不承擔任何義務更新此資訊以反映未來的事件或情況。現在我將電話轉給 Aethlon 臨時執行長兼財務長 James Frakes 先生。

  • James Frakes - Interim Chief Executive Officer, Chief Financial Officer, Senior Vice President - Finance, Company Secretary, Director

    James Frakes - Interim Chief Executive Officer, Chief Financial Officer, Senior Vice President - Finance, Company Secretary, Director

  • Thank you, Mich. And I would like to thank all of you for dialling in. This is James Frakes. Aethlon medical is continuing the research and clinical development of a single purifier, a therapeutic blood filtration system designed to bind and remove harmful exosomes and life-threatening viruses from blood and other biological fluids. These qualities of the Hemopurifier have potential applications in oncology or cancer associated exosomes may promote immune suppression and metathesis and the life-threatening infectious diseases.

    謝謝你,米奇。我要感謝大家撥電話。這是詹姆斯·弗雷克斯。Aethlon Medical 正在繼續研究和臨床開發單一淨化器,這是一種治療性血液過濾系統,旨在結合並去除血液和其他生物液體中的有害外泌體和危及生命的病毒。血液淨化器的這些特性在腫瘤學或癌症相關的外泌體中具有潛在的應用,可能會促進免疫抑制和復分解以及危及生命的傳染病。

  • Aethlon is also investigating the use of the Hemopurifier in the organ transplant setting, initially focusing on the potential removal of viruses and exosomes that harmful cargo from the covered kidneys. Dr. Steven LaRosa will give you an update on our efforts to date on the oncology front and on potential milestones that we hope to achieve later on this year.

    Aethlon 也正在研究血液淨化器在器官移植環境中的使用,最初的重點是清除覆蓋腎臟中有害物質的病毒和外泌體。Steven LaRosa 博士將向您介紹我們迄今為止在腫瘤學領域所做的努力以及我們希望在今年稍後實現的潛在里程碑的最新情況。

  • However, before I turn the call over to Dr. LaRosa , I want to note that we've received multiple inquiries regarding the current multistate outbreak of H5N1 Avian Influenza virus in dairy cattle. While the Hemopurifier has demonstrated the ability to capture prior iterations of the H5N1 bird flu virus in in- vitro experiments.

    然而,在我將電話轉給 LaRosa 博士之前,我想指出的是,我們已收到多個關於目前乳牛中多州爆發 H5N1 禽流感病毒的詢問。而血液淨化器已在體外實驗中證明了捕捉 H5N1 禽流感病毒先前迭代的能力。

  • We have not tested the Hemopurifier against the current strain, nor have there been many cases of the current strain infecting humans. The company will continue to monitor the situation and provide any potential updates as needed. It's also worth noting that in April 2024, the US Food and Drug Administration approved our internal manufacturing facility under our virology IDE. With that, I will now turn the call over to Dr. Steven LaRosa , Aethlon's Chief Medical Officer.

    我們尚未對血液淨化器針對當前菌株進行測試,也沒有出現許多當前菌株感染人類的病例。該公司將繼續監控情況並根據需要提供任何可能的更新。另外值得注意的是,2024 年 4 月,美國食品藥物管理局批准了我們病毒學 IDE 下的內部生產設施。現在,我將把電話轉給 Aethlon 首席醫療官 Steven LaRosa 博士。

  • Steven Larosa - Chief Medical Officer

    Steven Larosa - Chief Medical Officer

  • Thank you Jam. As announced on June 18, 2024, the Human Research Ethics Committee of the central Adelaide local health network granted all ethics approval for Aethlon safety, feasibility and dose-finding clinical trials of the Hemopurifier in cancer patients with solid tumors who have stable or progressive disease during anti-PD-1 monotherapy treatment such as Keytruda, pembrolizumab, or Opdivo, nivolumab, which is known as the AEMD-2022-06 Hemopurifier study.

    謝謝你,傑姆。正如2024 年6 月18 日宣布的那樣,阿德萊德中央地方衛生網絡的人類研究倫理委員會授予了Aethlon 血液淨化器在患有穩定或進展性疾病的實體瘤癌症患者中的安全性、可行性和劑量探索臨床試驗的所有倫理批准。

  • The approval is valid for three years until June 13, 2027. The trial will be conducted by Professor Michael Brown and his staff at the cancer clinical trials unit, Central Adelaide Local Health Network, Royal Adelaide Hospital located in Adelaide Australia. Currently only approximately 30% of patients have received pembrolizumab or nivolumab will have a lasting clinical response to these agents.

    此核准有效期三年,至2027年6月13日止。該試驗將由位於澳洲阿德萊德皇家阿德萊德醫院癌症臨床試驗部門、中央阿德萊德地方衛生網絡的邁克爾布朗教授及其工作人員進行。目前,只有大約 30% 接受過派姆單抗或納武單抗治療的患者會對這些藥物產生持久的臨床反應。

  • Extracellular vesicles produced by tumors have been implicated in the spread of cancers as well as resistance to the anti-PD-1 therapy. The Aethlon Hemopurifier has been designed to bind and remove these extracellular vesicles from the bloodstream, which may improve therapeutic response rates to anti-PD-1 antibodies.

    腫瘤產生的細胞外囊泡與癌症的擴散以及抗 PD-1 療法的抗藥性有關。Aethlon 血液淨化器旨在結合並去除血液中的這些細胞外囊泡,這可能會提高抗 PD-1 抗體的治療反應率。

  • In preclinical study for Hemopurifier has been shown to reduce the number of exosomes from the plasma of cancer patient samples. During the fourth quarter and subsequent period, we have continued to make significant progress advancing towards our planned safety, feasibility and dose-finding oncology trials in Australia and India, punctuated by the recent approval from the Human Rapid Research Ethics Committee at Central Adelaide Local Health Network.

    在臨床前研究中,血液淨化器已被證明可以減少癌症患者樣本血漿中外泌體的數量。在第四季度及隨後的時期內,我們繼續在澳大利亞和印度計劃的安全性、可行性和劑量探索腫瘤學試驗方面取得重大進展,最近阿德萊德中部地方衛生中心人類快速研究倫理委員會的批准也印證了這一點網路。

  • Upon submission to the Therapeutic Goods Administration which is the National Health Regulatory Agency of Australia, obtaining approval from the Central Adelaide Local Health Research Governance Committee and conducting a site initiation visit, we expect that we will be able to enroll and treat the first patient either in the September quarter or in the December quarter.

    在提交給治療產品管理局(澳洲國家衛生監管機構)、獲得阿德萊德中部地方健康研究管理委員會的批准並進行現場啟動訪問後,我們希望能夠招募並治療第一位患者在9 月季度或12 月季度。

  • We anticipate several upcoming potential value-creating milestones, including submission to the ethics committees at two additional sites in Australia and one in India with the expectation of possibly receiving approval from one or more of those three hospitals in the September quarter 2024, after which we expect to be able to enroll patients at these additional sites by the end of 2024.

    我們預計即將到來的幾個潛在的創造價值的里程碑,包括向澳大利亞另外兩個地點和印度一個地點的倫理委員會提交,預計可能在2024 年9 月季度獲得這三家醫院中的一家或多家醫院的批准,之後我們預計到 2024 年底能夠在這些額外地點招募患者。

  • As a reminder, the primary endpoint of the approximate 18 patient safety feasibility and dose-finding trial is safety. The trial will monitor any adverse events and clinically significant changes in lab tests of Hemopurifier treated patients with solid tumors with progressive or stable disease after a two month run-in period of anti-PD-1 antibody, Keytruda or Opdivo.

    提醒一下,大約 18 名患者的安全可行性和劑量探索試驗的主要終點是安全性。該試驗將監測血液淨化器治療的實體腫瘤患者在接受抗 PD-1 抗體、Keytruda 或 Opdivo 兩個月磨合期後的實驗室測試中出現的任何不良事件和臨床顯著變化。

  • Patients who did not respond to PD-1 antibody therapy will be eligible to enter the Hemopurifier period of the study, where sequential cohorts will receive one, two or three Hemopurifier treatments during a one week period. In addition to monitoring safety study is designed to examine the number of Hemopurifier treatment needed to decrease the concentration of EV's and if these changes in EV concentration, improve the body's own natural ability to attack tumor cells.

    對 PD-1 抗體治療沒有反應的患者將有資格進入研究的血液淨化器階段,其中連續隊列將在一周內接受一次、兩次或三次血液淨化器治療。除了監測安全性之外,研究還旨在檢查降低 EV 濃度所需的血液淨化器治療次數,以及 EV 濃度的這些變化是否會提高人體自身攻擊腫瘤細胞的自然能力。

  • These exploratory central laboratory analyses are expected to inform the design have a subsequent efficacy and safety trial, including a premarket approval of noted as a PMA study required by the FDA and other regulatory agencies.

    這些探索性中心實驗室分析預計將為隨後的功效和安全性試驗的設計提供信息,包括 FDA 和其他監管機構要求的 PMA 研究的上市前批准。

  • The company is also maintaining a position to use for the Hemopurifier as a treatment against life-threatening viral infections through its COVID-19 trial in India. There are two participating sites for this trial, Medanta Medicity Hospital and Maulana Azad Medical College. One patient has been treated thus far.

    透過在印度進行的 COVID-19 試驗,該公司也維持了使用血液淨化器治療危及生命的病毒感染的地位。該試驗有兩個參與地點:Medanta Medicity 醫院和 Maulana Azad 醫學院。目前已有一名患者接受治療。

  • However, the company has been informed by its contract research organization that a new COVID-19 variant was recently detected in India. The COVID-19 trial in India remains open in the event that there are COVID-19 admissions to the intensive care unit at these two participating sites.

    然而,該公司從其合約研究組織獲悉,最近在印度發現了一種新的 COVID-19 變種。如果這兩個參與地點的重症監護病房有 COVID-19 入院,印度的 COVID-19 試驗仍然開放。

  • With that, I'll turn the call back over to Jim for the financial discussion and then open up for questions.

    這樣,我會將電話轉回給吉姆進行財務討論,然後再提出問題。

  • James Frakes - Interim Chief Executive Officer, Chief Financial Officer, Senior Vice President - Finance, Company Secretary, Director

    James Frakes - Interim Chief Executive Officer, Chief Financial Officer, Senior Vice President - Finance, Company Secretary, Director

  • Thank you, Steve, and good afternoon again to everyone. Before I turn to the financial matters, I just want to say after being in this position for about six months, I'm very pleased and excited that we are moving forward now with this clinical trial, and we're excited.

    謝謝你,史蒂夫,再次祝大家下午好。在談到財務問題之前,我只想說,在擔任這個職位大約六個月後,我非常高興和興奮,我們現在正在推進這項臨床試驗,我們很興奮。

  • On to the finances. As of March 31, 2024, Aethlon Medical had a cash balance of approximately $5.4 million. And as of June 25, 2024, we had a cash balance of approximately $9.1 million. And as I've been previously encourage not to cover our expenses on such a granular basis. like I had done previously or tried to keep my remarks at a higher level this quarter.

    說到財務。截至 2024 年 3 月 31 日,Aethlon Medical 的現金餘額約為 540 萬美元。截至 2024 年 6 月 25 日,我們的現金餘額約為 910 萬美元。正如我之前所鼓勵的那樣,不要如此細粒度地支付我們的費用。就像我之前所做的那樣,或者試圖在本季度將我的言論保持在更高的水平。

  • You'll find detailed expense information on the financial statements attached to our earnings release that just hit the wire or in our soon to be filed report on Form 10-K.

    您可以在我們剛發布的收益發布所附的財務報表或即將提交的 10-K 表格報告中找到詳細的費用資訊。

  • Our consolidated operating expenses for the fiscal year ended March 31, 2024, were approximately $12.6 million compared to approximately $12.5 million for the fiscal year ended March 31, 2023, an increase of approximately $164,000. This increase in the fiscal year ended March 31, 2024 was due to an increase in payroll and related expenses of approximately $763,000, partially offset by decreases in G&A expenses of approximately $578,000, and then professional fees of approximately $21,000.

    截至 2024 年 3 月 31 日的財年,我們的綜合營運費用約為 1,260 萬美元,而截至 2023 年 3 月 31 日的財年約為 1,250 萬美元,增加了約 164,000 美元。截至 2024 年 3 月 31 日的財年的這一增長是由於工資和相關費用增加了約 763,000 美元,部分被約 578,000 美元的一般及行政費用減少以及約 21,000 美元的專業費用的減少所抵消。

  • The approximate $763,000 increase in payroll and related expenses was primarily due to separation expenses for the company's former Chief Executive Officer of $862,000, and we had an increase of $127,000 associated with an increase in average headcount. And those were partially offset by a decrease in stock-based comp of the $226,000.

    薪資和相關費用增加了大約 763,000 美元,主要是由於公司前執行長的離職費用為 862,000 美元,而我們的平均員工人數增加了 127,000 美元。這些損失被股票補償減少 226,000 美元部分抵消。

  • The approximate $578,000 decrease in general and administrative expenses was primarily driven by a direct decrease of $819,000 in clinical trial expenses related to the closed US COVID-19 clinical trial, a decrease of $280,000 in subcontract expense related to contracts and grants with the National Institutes of Health and $99,000 decrease in rent expense associated with a mobile clean room leased in the prior year, a decrease of $30,000 in travel related expenses associated with the former remote employee and a decrease of $22,000 in expenses related to various other general office and operating expenses.

    一般和管理費用減少約578,000 美元,主要是由於與已結束的美國COVID-19 臨床試驗相關的臨床試驗費用直接減少了819,000 美元,與美國國立衛生研究院的合約和撥款相關的分包費用減少了28 萬美元。與上一年租賃的行動無塵室相關的健康費用和租金費用減少了99,000 美元,與前遠距員工相關的差旅相關費用減少了30,000 美元,與各種其他一般辦公室和營運費用相關的費用減少了22,000 美元。

  • These decreases were partially offset by an increase of $405,000 in manufacturing and R&D supplies related to manufacturing Hemopurifier devices and various R&D activities. And the approximate $21,000 decrease in professional fees was primarily due to a decrease in outside scientific product research and regulatory services of $303,000, a decrease of $60,000 in recruiting fees and a $33,000 decrease in legal fees.

    這些減少被與製造血液淨化器設備和各種研發活動相關的製造和研發供應增加 405,000 美元部分抵消。專業費用減少了約 21,000 美元,主要是由於外部科學產品研究和監管服務減少了 303,000 美元,招聘費用減少了 60,000 美元,法律費用減少了 33,000 美元。

  • These decreases were partially offset by increases in Investor Relations of $151,000, accounting fees of $137,000 and Board of Director fees of $34,000 and outside operational and administrative expenses of $53,000.

    這些減少被投資者關係費用增加 151,000 美元、會計費用增加 137,000 美元、董事會費用增加 34,000 美元以及外部營運和管理費用增加 53,000 美元部分抵消。

  • As a result of the factors I just mentioned, Aethlon net loss increased to $12.2 million for the fiscal year ended March 31, 2024 from $12.0 million for the fiscal year ended March 31, 2023. We included these earnings results and related commentary in a press release issued earlier this afternoon. That release included the balance sheet for March 31, 2024 and the statements of operations for the fiscal years ended March 31, 2024 and 2023. We will file our annual report on Form 10-K following this call.

    由於我剛才提到的因素,Aethlon 的淨虧損從截至 2023 年 3 月 31 日的財年的 1,200 萬美元增至截至 2024 年 3 月 31 日的財年的 1,220 萬美元。我們在今天下午早些時候發布的新聞稿中納入了這些盈利結果和相關評論。新聞稿包括2024年3月31日的資產負債表以及截至2024年3月31日和2023年3月31日的財政年度的營運報表。本次電話會議後,我們將提交 10-K 表年度報告。

  • Our next earnings call for the fiscal first quarter ending June 30, 2024, will coincide with the filing of our quarterly report on Form 10-Q in August 2024. And now Steve and I would be happy to take any questions that you may have. Operator, please open the call for questions.

    我們的下一次財報電話會議將於 2024 年 6 月 30 日結束的第一財季召開,屆時我們將在 2024 年 8 月提交 10-Q 表格季度報告。現在,史蒂夫和我很樂意回答您可能提出的任何問題。接線員,請打開電話提問。

  • Operator

    Operator

  • Yes sir. We will now begin the question and answer session. (Operator Instructions)

    是的,先生。我們現在開始問答環節。(操作員說明)

  • Marla Marin, Zacks.

    瑪拉馬林,札克斯。

  • Marla Marin - Analyst

    Marla Marin - Analyst

  • Thank you. So good afternoon. Can you talk a little bit, obviously, it was a pretty big announcement you had about the approval from the ethics board. Can you talk a little bit about how you see that possibly facilitating moving forward additional venue?

    謝謝。午安.您能簡單說一下嗎?您能否談談您如何看待這可能有助於推進更多場地?

  • James Frakes - Interim Chief Executive Officer, Chief Financial Officer, Senior Vice President - Finance, Company Secretary, Director

    James Frakes - Interim Chief Executive Officer, Chief Financial Officer, Senior Vice President - Finance, Company Secretary, Director

  • Steve, do you want to take that?

    史蒂夫,你想接受這個嗎?

  • Steven Larosa - Chief Medical Officer

    Steven Larosa - Chief Medical Officer

  • Sure. Thanks, Marla. So in Australia, things work in a different fashion than in the US where the primary gatekeeper for going forward, the clinical trial is the FDA. In Australia, you go first to the Ethics Board Committees, ethics committees at the hospitals. They're the primary gatekeeper where they follow the rules and the national statement for the scientific merit and the ethics of doing a study.

    當然。謝謝,瑪拉。因此,在澳大利亞,事情的運作方式與美國不同,在美國,臨床試驗的主要看門人是 FDA。在澳大利亞,您首先會去道德委員會,醫院的道德委員會。他們是主要的看門人,遵守規則和國家聲明,以確保研究的科學價值和道德規範。

  • So, the approval from the Central Adelaide Local Health Network is an important milestone, because now we can submit to the governance committee at the hospital which looks at the logistics of the study and we can inform the TGA, which is the FDA equivalent in Australia. We can inform them and notify them that we're going to go forward.

    因此,阿德萊德中央地方衛生網絡的批准是一個重要的里程碑,因為現在我們可以向醫院的治理委員會提交該報告,該委員會負責研究研究的後勤工作,並且我們可以通知TGA(澳大利亞的FDA 相當於) 。我們可以通知他們並通知他們我們將繼續前進。

  • So it really is a big lever that's pressed to initiate. And as you said, we will submit to the TGA for the notification, we'll get governance, we'll seek governance approval from the hospital and then we'll do a final trading. But this is the first step of everything else in motion. And the one thing I will say is the other hospital that will be submitted to in Australia, it's important to them that an Ethics Committee at another site has already approved. That facilitates things in their review.

    所以它確實是一個按下啟動的大槓桿。正如你所說,我們將向 TGA 提交通知,我們將獲得治理,我們將尋求醫院的治理批准,然後我們將進行最終交易。但這是其他一切行動的第一步。我要說的一件事是將提交給澳洲的另一家醫院,對他們來說很重要的是另一個地點的道德委員會已經批准了。這有利於他們的審查。

  • Marla Marin - Analyst

    Marla Marin - Analyst

  • Thank you. That makes sense. And in terms of how this study is designed to include patients who are, who have various different types of tumors. Can you talk a little bit about how you see that potentially helping to facilitate patient enrollment?

    謝謝。這是有道理的。就這項研究的設計方式而言,包括患有各種不同類型腫瘤的患者。您能否談談您如何看待這可能有助於促進病患登記?

  • Steven Larosa - Chief Medical Officer

    Steven Larosa - Chief Medical Officer

  • Yes. So the study that's going forward in Australia and India is what's called a basket trial, which means we're not we're being agnostic to the tumor type that we may benefit. We're actually going to be able to enroll and any patient who has a solid tumor type for which an anti-PD-1 therapy is standard of care. And after a two month period those that aren't responding will go on.

    是的。因此,澳洲和印度正在進行的研究被稱為“籃子試驗”,這意味著我們對可能受益的腫瘤類型不可知。實際上,我們將能夠招募任何患有以抗 PD-1 治療為標準治療的實體腫瘤類型的患者。兩個月後,那些沒有回應的人將繼續。

  • So we would -- for data from the trial will inform us about the effect in more than a single tumor type. It will include such very common tumors as non-small cell lung cancer as well as on melanoma, which is quite a problem in Australia. So we'll be able to get data from a variety of tumor types.

    因此,我們會—因為試驗數據將告訴我們該藥物對多種腫瘤類型的影響。它將包括非小細胞肺癌和黑色素瘤等非常常見的腫瘤,這在澳洲是一個相當大的問題。因此我們將能夠從各種腫瘤類型中獲取數據。

  • It's also set up in such a way that we can examine the interval of dosing with the Hemopurifier to determine how often would you need to administer the treatments to have a lasting effect on decreasing exosomes and improving the immune system. So well, it will provide a dataset that will allow the design of the efficacy trial that I mentioned, the PMA trial.

    它的設定方式還使我們可以檢查血液淨化器的給藥間隔,以確定您需要多久進行一次治療,才能對減少外泌體和改善免疫系統產生持久效果。那麼,它將提供一個資料集,允許設計我提到的功效試驗,即 PMA 試驗。

  • Marla Marin - Analyst

    Marla Marin - Analyst

  • Well, thank you.

    嗯,謝謝。

  • Operator

    Operator

  • Anthony Vendetti, Maxim Group.

    安東尼文代蒂,馬克西姆集團。

  • Unidentified Participant

    Unidentified Participant

  • Hi. This is actually Jeremy on line for Anthony. How are you doing? Two quick questions. So, if hopefully if you get all these other approvals that you need to begin this clinical trial, when do you think you have 18 patients, what do you think the timeline for that would be?

    你好。這實際上是傑里米為安東尼在線。你好嗎?兩個簡單的問題。那麼,如果您希望獲得開始這項臨床試驗所需的所有其他批准,那麼您認為您何時有 18 名患者,您認為時間表會是多少?

  • You mentioned that you hope to get the first patient enrolled either in the, let's say, the third or fourth quarter of the calendar quarter. But then when do you think, how do you think the rest of the timeline plays out? And then when you could start the next, the PMA study?

    您提到您希望讓第一位患者在日曆季度的第三或第四季度註冊。但你認為時間軸的其餘部分什麼時候會發生?然後你什麼時候可以開始下一個 PMA 研究?

  • James Frakes - Interim Chief Executive Officer, Chief Financial Officer, Senior Vice President - Finance, Company Secretary, Director

    James Frakes - Interim Chief Executive Officer, Chief Financial Officer, Senior Vice President - Finance, Company Secretary, Director

  • Steve, do you want to reply ?

    史蒂夫,你想回覆嗎?

  • Steven Larosa - Chief Medical Officer

    Steven Larosa - Chief Medical Officer

  • Yes. So, the way the study is set up, we specifically did feasibility assessments at the three sites that we mentioned in Australia, as well as the site in India. So, we know that these are high quality active cancer clinical trial units and we've done due diligence that they have the patients who are getting the anti-PD-1 therapies that we mentioned, nivolumab and pembrolizumab.

    是的。因此,根據研究的設置方式,我們專門在澳洲提到的三個地點以及印度的地點進行了可行性評估。因此,我們知道這些是高品質的活躍癌症臨床試驗單位,我們已經進行了盡職調查,他們的患者正在接受我們提到的抗 PD-1 療法,納武單抗和派姆單抗。

  • So, I can't give you what the exact enrollment rates will be, but at least we've done our feasibility that these are sites that have a reasonably large patient population in which screening can take place. So, we're anticipating based on our feasibility status that enrollment will proceed in a timely fashion.

    因此,我無法告訴您確切的登記率是多少,但至少我們已經完成了可行性研究,這些地點擁有相當多的患者群體,可以進行篩檢。因此,根據我們的可行性狀況,我們預計註冊將及時進行。

  • Unidentified Participant

    Unidentified Participant

  • Okay, understood. Thank you. And then just moving, I know it seems like oncology is your number one focus right now, but you have mentioned in the press release and in the past about an opportunity in organ transplant. And you did say that you had some publications, I think you may be working on. Is there, maybe you can give us some update on that that would be helpful? Thank you.

    好的,明白了。謝謝。然後就移動,我知道腫瘤學似乎是您現在的首要關注點,但您在新聞稿中和過去都提到器官移植的機會。你確實說過你有一些出版物,我想你可能正在研究。您是否可以提供我們一些有用的最新資訊?謝謝。

  • James Frakes - Interim Chief Executive Officer, Chief Financial Officer, Senior Vice President - Finance, Company Secretary, Director

    James Frakes - Interim Chief Executive Officer, Chief Financial Officer, Senior Vice President - Finance, Company Secretary, Director

  • Sure, Jeremy. This is Jam. We do have most of our publications drafted, I'm told. And we'll get that published sooner rather than later, I think. There's no date in mind. Aethlon perhaps has come across as a little schizophrenic in the past. I'm trying to really have a solid focus on oncology. But the paper's mostly written. Our technology appears to work well in that organ transplant setting in the perquisites.

    當然,傑里米。這是果醬。有人告訴我,我們確實已經起草了大部分出版品。我想我們會盡快發布它。心裡沒有日期。Aethlon 過去或許給人一種有點精神分裂的感覺。我正在努力真正專注於腫瘤學。但論文大部分已寫完。我們的技術似乎在器官移植環境中運作良好,並有額外的條件。

  • So, we do want to get that information out. And there may be opportunities to hook up in some fashion with organ procurement operations across the country or there are firms that are commercial firms that play in that industry and that might be a good opportunity to work with them instead of doing it on our own. But it's early days, we will see how that works.

    所以,我們確實想得到這些資訊。可能有機會以某種方式與全國各地的器官採購業務聯繫起來,或者有一些公司是從事該行業的商業公司,這可能是與他們合作而不是我們自己做的好機會。但現在還為時過早,我們將看看它是如何運作的。

  • Unidentified Participant

    Unidentified Participant

  • Okay, great. Thank you so much. I'll hop back in the queue.

    好的,太好了。太感謝了。我會跳回到隊列中。

  • James Frakes - Interim Chief Executive Officer, Chief Financial Officer, Senior Vice President - Finance, Company Secretary, Director

    James Frakes - Interim Chief Executive Officer, Chief Financial Officer, Senior Vice President - Finance, Company Secretary, Director

  • Thanks, Jeremy.

    謝謝,傑里米。

  • Operator

    Operator

  • This concludes our question and answer session. I would like to turn the conference back over to Mr. James Frakes for any closing remarks. Please go ahead, sir.

    我們的問答環節到此結束。我想將會議轉交詹姆斯·弗雷克斯先生發表閉幕詞。請繼續,先生。

  • James Frakes - Interim Chief Executive Officer, Chief Financial Officer, Senior Vice President - Finance, Company Secretary, Director

    James Frakes - Interim Chief Executive Officer, Chief Financial Officer, Senior Vice President - Finance, Company Secretary, Director

  • Thank you again for joining us today to discuss our year-end results, and we look forward to keeping you up-to-date on future calls. Have a good day. Thanks. Bye.

    再次感謝您今天加入我們討論我們的年終業績,我們期待在未來的電話會議中向您通報最新情況。祝你有美好的一天。謝謝。再見。

  • Operator

    Operator

  • The conference is 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。