使用警語:中文譯文來源為 Google 翻譯,僅供參考,實際內容請以英文原文為主
Operator
Operator
Good day and welcome to the Aethlon Medical's third-quarter fiscal 2024 earnings and corporate update. (Operator Instructions) Please note, today's event is being recorded.
美好的一天,歡迎來到 Aethlon Medical 的 2024 財年第三季財報和公司更新。(操作員說明)請注意,今天的活動正在錄製中。
I would now like to turn the conference over to Michael Miller with Rx Communications. Please go ahead.
我現在想將會議轉交給 Rx Communications 的 Michael Miller。請繼續。
Michael Miller - IR
Michael Miller - IR
Thank you, operator, and good afternoon, everyone. Welcome to Aethlon Medical's third-quarter fiscal 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 third fiscal quarter ended December 31, 2023. If you have not seen or received Aethlon Medical's earnings release, please visit the Investors page at www.AethlonMedical.com.
謝謝接線員,大家下午好。歡迎參加 Aethlon Medical 2024 財政年度第三季財報電話會議。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 2023 年 12 月 31 日的第三財季財務業績。如果您尚未看到或收到 Aethlon Medical 的收益發布,請造訪 www.AethlonMedical.com 的投資者頁面。
Following this introduction and the reading of the company's forward-looking statement, Aethlon's Interim Chief Executive Officer and Chief Financial Officer, James Frakes; and 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's financials. We'll 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 臨時執行長兼財務長 James Frakes 表示: Aethlon 的首席醫療官 Steven LaRosa 博士將概述 Aethlon 的策略和最新進展。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.
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。
These statements are based on expectations and assumptions as of the date of this conference call. 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.
這些陳述是基於截至本次電話會議之日的預期和假設。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。
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, 2023, and the company's most recent report on Form 10-Q and in the company's other filings with the Securities and Exchange Commission. 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 circumstances.
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 2023 年 3 月 31 日的財年 10-K 表格年度報告中的「風險因素」標題下找到,以及公司最新的報告表格10-Q 以及公司向美國證券交易委員會提交的其他文件中。除非法律要求,否則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。
With that, I'll now turn the call over to Mr. James Frakes, Aethlon's Interim Chief Executive Officer and Chief Financial Officer. Jim?
現在,我將把電話轉給 Aethlon 臨時執行長兼財務長 James Frakes 先生。吉姆?
James Frakes - Interim CEO, CFO, SVP - Finance, Company Secretary, & Director
James Frakes - Interim CEO, CFO, SVP - Finance, Company Secretary, & Director
Thank you, Mike. And I'd like to thank all of you for dialing in. This is Jim Frakes, Interim CEO and long-time CFO of Aethlon Medical.
謝謝你,麥克。我要感謝大家撥電話。我是吉姆‧弗雷克斯 (Jim Frakes),Aethlon Medical 臨時執行長兼長期財務長。
In October 2023, Aethlon received clearance from the Drug Controller General of India, or DCGI, the country's Central Drug Authority, to conduct a Phase 1 safety, feasibility, and dose-finding trial of the Hemopurifier in patients with solid tumors who have stable or progressive disease during anti-PD-1 monotherapy treatment such as Keytruda or Opdivo. The trial is expected to begin following completion of an in vitro binding study of relevant targets and subsequent approval by the respective ethics boards of interested sites in India.
2023 年10 月,Aethlon 獲得印度藥品監管總局(DCGI)(印度中央藥品管理局)的許可,可在病情穩定或病情穩定的實體瘤患者中進行血液淨化器的1 期安全性、可行性和劑量探索試驗。該試驗預計將在完成相關目標的體外結合研究並隨後獲得印度感興趣地點的各自倫理委員會批准後開始。
In addition to an interested initial site in India, we have three interested sites in Australia that are also awaiting the data from our in vitro binding study. Our in vitro binding study of relevant oncology targets is complex and stands on the cutting edge of extracellular vesicle science.
除了印度的一個感興趣的初始站點外,我們在澳洲還有三個感興趣的站點,它們也在等待我們的體外結合研究的數據。我們對相關腫瘤標靶的體外結合研究非常複雜,並且處於細胞外囊泡科學的前沿。
Our goal is to quantify the potential impact of our Hemopurifier on plasma from cancer patients who have been treated with anti-PD-1 monotherapy treatment in order to provide pre-clinical evidence to support our trial design. While our R&D team has started to quantify our internal data, the results to date are inconclusive.
我們的目標是量化我們的血液淨化器對接受抗 PD-1 單藥治療的癌症患者血漿的潛在影響,以便提供臨床前證據來支持我們的試驗設計。雖然我們的研發團隊已開始量化我們的內部數據,但迄今為止的結果尚無定論。
Therefore, while our internal team continues to fine-tune their work, in parallel, we have now engaged several third-party laboratories to independently perform assays on the samples. We are also continuing the study -- to study the use of our Hemopurifier as a treatment against life-threatening viral infections through our COVID-19 trial in India.
因此,在我們的內部團隊不斷調整工作的同時,我們現在已經聘請了幾個第三方實驗室來獨立對樣本進行檢測。我們也正在繼續這項研究——透過在印度進行的 COVID-19 試驗,研究使用我們的血液淨化器來治療危及生命的病毒感染。
We have two participating sites for this trial, the Medanta Medicity Hospital and Maulana Azad Medical College or MAMC. One patient has been treated to date. Recently, we have been informed by our contract research organization that a new COVID-19 subvariant has been detected in India. Our COVID-19 trial in India remains open in the event that there are COVID-19 admissions through the intensive care units at our two participating sites.
我們有兩個參與本試驗的地點:Medanta Medicity 醫院和 Maulana Azad 醫學院或 MAMC。迄今為止,已有一名患者接受治療。最近,我們的合約研究組織通知我們,在印度發現了一種新的 COVID-19 亞變體。如果我們兩個參與地點的重症監護病房有 COVID-19 入院,我們在印度的 COVID-19 試驗仍然開放。
Finally, since being named Interim Chief Executive Officer three months ago, I have focused our efforts on our oncology program as well as on reducing our expenses. As previously reported, we disclosed some interesting pre-clinical proof-of-concept data of the Hemopurifier in organ transplantation. As a result, we do plan to submit one or more articles for publication on our pre-clinical organ transplantation data.
最後,自從三個月前被任命為臨時執行長以來,我一直將工作重點放在腫瘤學計畫以及減少開支。如同先前所報導的,我們揭露了血液淨化器在器官移植中的一些有趣的臨床前概念驗證數據。因此,我們確實計劃提交一篇或多篇關於我們的臨床前器官移植數據的文章以供發表。
With that, I will now turn the call over to Dr. Steven LaRosa, Aethlon's Chief Medical Officer.
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, Jim. The clinical team at Aethlon continues to make strides toward initiating oncology studies in India and Australia. As a reminder, these studies will examine the safety and feasibility of the Hemopurifier in patients who are not responding to anti-PD-1 antibodies following an initial 60-day treatment period. The trial will also examine exosome removal by the Hemopurifier and the downstream effects on reversal of T-cell immunosuppression.
謝謝你,吉姆。Aethlon 的臨床團隊繼續在印度和澳洲啟動腫瘤學研究方面取得進展。提醒一下,這些研究將檢查血液淨化器對於在初始 60 天治療期後對抗 PD-1 抗體沒有反應的患者的安全性和可行性。該試驗還將檢查血液淨化器去除外泌體的情況以及逆轉 T 細胞免疫抑制的下游影響。
Three interested sites have been identified in Australia and one in India. Two of the three sites in Australia have already completed successful site qualification visits known as SQVs, and we are in the advanced stages of budget and clinical trial agreements or CTA negotiation.
已在澳洲確定了三個感興趣的地點,在印度確定了一個。澳洲的三個站點中的兩個已經成功完成了被稱為 SQV 的站點資格訪問,我們正處於預算和臨床試驗協議或 CTA 談判的後期階段。
The major milestone for site activation and enrollment is approval by each hospital's Ethics Committee. The three main documents that these committees examine are, one, the clinical trial protocol; two, the informed -- the patient informed consent, known as the ICF; and three, the clinical investigator brochure, known as the CIB. The Aethlon team has finalized the protocol and the informed consent documents. The clinical investigator brochure can be finalized once the results of the in vitro binding studies are available.
站點啟動和註冊的主要里程碑是每家醫院倫理委員會的批准。這些委員會審查的三個主要文件是:一是臨床試驗計畫;二是臨床試驗方案。二、知情-病人知情同意,稱為ICF;三是臨床研究者手冊,稱為 CIB。Aethlon 團隊已最終確定方案和知情同意文件。一旦獲得體外結合研究的結果,即可最終確定臨床研究者手冊。
Additionally, we are finalizing other important documents necessary for the conduct of the trial, including the electronic case report form known as the EDC, the safety monitoring plan, the statistical analysis plan, and the charter that the independent Data Safety Monitoring Board will use. In short, we are poised for site activation once our in vitro studies are completed.
此外,我們正在最終確定進行試驗所需的其他重要文件,包括稱為 EDC 的電子病例報告表、安全監測計劃、統計分析計劃以及獨立資料安全監測委員會將使用的章程。簡而言之,一旦我們的體外研究完成,我們就準備好進行位點活化。
With that, I'll turn the call back over to Jim for the financial discussion, and he will open it up for questions.
這樣,我會將電話轉回給吉姆進行財務討論,然後他將開放提問。
James Frakes - Interim CEO, CFO, SVP - Finance, Company Secretary, & Director
James Frakes - Interim CEO, CFO, SVP - Finance, Company Secretary, & Director
Thanks, Steve. And good afternoon again, everyone. As of December 31, 2023, Aethlon Medical had a cash balance of approximately $8 million. During December and January, we raised approximately $236,000 through common stock sales under our at-the-market program.
謝謝,史蒂夫。大家下午好。截至2023年12月31日,Aethlon Medical的現金餘額約為800萬美元。12 月和 1 月期間,我們透過市場計畫下的普通股銷售籌集了約 236,000 美元。
Now, as I've been previously encouraged not to cover our expenses on such a granular basis as I did on prior calls, I will try to keep my remarks a bit more high level this quarter. You will find detailed expense information in the financial statements attached to our earnings release that just hit the wire or on our soon-to-be-filed quarterly report on Form 10-Q.
現在,正如我之前被鼓勵不要像之前的電話會議那樣詳細地支付我們的費用,我將盡力在本季度的言論中保持更高的水平。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-Q 表格季度報告中找到詳細的費用資訊。
Our consolidated operating expenses for the three months ended December 31, 2023, were approximately $3.6 million compared to $2.8 million for the three months ended December 31, 2022. This increase of approximately $717,000 or 25.2% in the 2023 period was due to an increase in payroll and related expenses of approximately $871,000 offset by decreases in general and administrative expenses of approximately $92,000 and in professional fees of approximately $61,000.
截至2023年12月31日止三個月的綜合營運費用約為360萬美元,而截至2022年12月31日止三個月的綜合營運費用為280萬美元。2023 年期間增加約 717,000 美元或 25.2%,原因是工資和相關費用增加約 871,000 美元,但被一般和管理費用約 92,000 美元以及專業費用約 61,000 美元的減少所抵消。
The $871,000 increase in payroll and related expenses was primarily due to separation expenses for our former CEO of $873,000 and an increase in salary expense of $81,000 associated with an increase in average headcount. This was offset by a decrease in stock-based compensation of $83,000.
薪資和相關費用增加 871,000 美元,主要是由於我們前執行長的離職費用為 873,000 美元,以及與平均員工人數增加相關的工資費用增加了 81,000 美元。這被股票薪酬減少 83,000 美元所抵消。
Now I'd like to note that without the $873,000 separation expense that was accrued related to our former CEO, both our payroll expense and our overall operating expenses would have actually decreased from the 2022 period. The $92,000 decrease in general and administrative expenses was primarily due to a decrease in clinical trial expense of approximately $399,000. That decrease was offset by a $284,000 increase in supplies for manufacturing and R&D and a $31,000 increase in insurance expense.
現在我想指出的是,如果沒有與我們前任執行長相關的 873,000 美元離職費用,我們的薪資費用和整體營運費用實際上都會比 2022 年期間有所減少。一般及管理費用減少 92,000 美元主要是由於臨床試驗費用減少約 399,000 美元。這一減少被製造和研發供應增加 284,000 美元以及保險費用增加 31,000 美元所抵消。
That increase in insurance expense included $16,000 of health insurance expense related to the separation agreement with our former CEO. And the $61,000 decrease in professional fees was due to a $54,000 decrease in scientific consulting, a $22,000 decrease in marketing, a $21,000 decrease in recruiting, and a net $33,000 decrease in contract labor related to general R&D.
保險費用的增加包括與前任執行長的離職協議相關的 16,000 美元健康保險費用。專業費用減少 61,000 美元,是由於科學諮詢費用減少了 54,000 美元,行銷費用減少了 22,000 美元,招聘費用減少了 21,000 美元,以及與一般研發相關的合約工淨減少了 33,000 美元。
These decreases were offset by an increase of $44,000 in legal expenses, primarily related to a reverse stock split and $11,000 increase in director fees associated with the addition of a new director, and a $14,000 increase in investor relations and accounting fees.
這些減少被法律費用增加 44,000 美元所抵消,主要與反向股票分割有關,與增加新董事相關的董事費用增加 11,000 美元,以及投資者關係和會計費用增加 14,000 美元。
As a result of the changes and expenses that I just noted, the company's net loss increased to $3.6 million for the three months ended December 31, 2023, from $2.8 million in the three months ended December 31, 2022. We included these earnings results and related commentary in our press release issued earlier this afternoon.
由於我剛才提到的變化和費用,該公司截至2023年12月31日止三個月的淨虧損從截至2022年12月31日止三個月的280萬美元增至360萬美元。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。
That release included the balance sheet for December 31, 2023, and the statements of operations for the three and nine months ended December 31, 2023, and 2022. We will file our quarterly report on Form 10-Q following this call. Our next earnings call for the fiscal fourth quarter ending March 31, 2024, will coincide with the filing of our annual report on Form 10-K in June 2024.
新聞稿包括2023年12月31日的資產負債表,以及截至2023年12月31日和2022年12月31日的三個月和九個月的營運報表。在本次電話會議之後,我們將提交 10-Q 表格的季度報告。我們的下一次財報電話會議將於 2024 年 3 月 31 日結束的第四財季召開,屆時我們將在 2024 年 6 月提交 10-K 表格年度報告。
And now, Steve and I will be happy to take any questions that you may have. Operator, please open the call for questions.
現在,史蒂夫和我將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
(Operator Instructions) Marla Marin, Zacks.
(操作員說明)Marla Marin,Zacks。
Marla Marin - Analyst
Marla Marin - Analyst
Thank you. Hello. So I have a couple of housekeeping questions and then one sort of broader-picture question. Soin India, regarding your continued COVID trials, there still is an uptick in COVID cases. Will that make it easier for patient enrollment in your bigger trial there?
謝謝。你好。所以我有幾個內務問題,然後是一個更宏觀的問題。因此,在印度,關於您繼續進行的新冠病毒試驗,新冠病毒病例仍在增加。這會讓患者更容易參加更大的試驗嗎?
James Frakes - Interim CEO, CFO, SVP - Finance, Company Secretary, & Director
James Frakes - Interim CEO, CFO, SVP - Finance, Company Secretary, & Director
Steve, do you want to take that one?
史蒂夫,你想拿走那個嗎?
Steven LaRosa - Chief Medical Officer
Steven LaRosa - Chief Medical Officer
Yes. Hi, Marla. So yes, the trial, as you'll recall, is for severely ill patients. So those are patients in the intensive care unit. So what we know from our CRO is that cases are occurring with this new variant. this JN.1 variant. We don't know yet if that's going to translate into the critically ill populations or not, but the sites are open and open for enrollment. And so if those patients are in the ICU, yes, we'd be able to enroll them.
是的。嗨,瑪拉。所以,是的,正如您所記得的那樣,該試驗是針對重症患者的。這些是重症監護室的病人。因此,我們從 CRO 了解到,這種新變種的病例正在發生。這個 JN.1 變體。我們還不知道這是否會轉化為危重病人,但這些網站已經開放並可供註冊。因此,如果這些患者在加護病房,我們就可以讓他們入組。
James Frakes - Interim CEO, CFO, SVP - Finance, Company Secretary, & Director
James Frakes - Interim CEO, CFO, SVP - Finance, Company Secretary, & Director
And we have Hemopurifiers there waiting to doctors have been trained. In fact, the doctors of Medanta Medicity have very deep experience using the Hemopurifier in prior trials.
我們在那裡有血液淨化器等待接受過訓練的醫生。事實上,Medanta Medicity的醫生在先前的試驗中使用血液淨化器有著非常豐富的經驗。
Steven LaRosa - Chief Medical Officer
Steven LaRosa - Chief Medical Officer
So they're at the ready, so to speak. It's just whether the patients -- critically ill population is there or not.
所以可以這麼說,他們已經準備好了。問題只是在於病人——重症患者是否存在。
Marla Marin - Analyst
Marla Marin - Analyst
Got it. Okay. That also, Jim, what you just said leads me to another question, which is, are we to understand that you have a sufficient number of Hemopurifiers at the moment to support all of the clinical efforts that you're looking to conduct at least in the near term?
知道了。好的。吉姆,您剛才所說的也讓我想到了另一個問題,即我們是否理解您目前擁有足夠數量的血液淨化器來支持您至少在近期?
James Frakes - Interim CEO, CFO, SVP - Finance, Company Secretary, & Director
James Frakes - Interim CEO, CFO, SVP - Finance, Company Secretary, & Director
We do for the planned oncology trials. If all hell broke loose with COVID, that's an unknown. We do -- we have a cache of Hemopurifiers in India awaiting at those two sites. So it would need to be a massive outbreak with a lot of people in the ICUs to cause a problem. So I think we're in pretty good shape, actually, Marla.
我們為計劃中的腫瘤學試驗做這件事。如果新冠疫情徹底爆發,那還是個未知數。我們確實這麼做了——我們在印度有一批血液淨化器在這兩個地點等著。因此,只有在加護病房裡有很多人的情況下才會出現大規模爆發,才會造成問題。所以我認為我們的狀態實際上很好,瑪拉。
Marla Marin - Analyst
Marla Marin - Analyst
Okay. Then you talked about some one-off costs in the third quarter, one-off expenses associated with the separation from the former CEO. Are there any one-off costs that are going to spill over into the fourth quarter?
好的。然後您談到了第三季的一些一次性成本,即與前任執行長離職相關的一次性費用。是否有任何一次性成本會蔓延到第四季?
James Frakes - Interim CEO, CFO, SVP - Finance, Company Secretary, & Director
James Frakes - Interim CEO, CFO, SVP - Finance, Company Secretary, & Director
No. The accounting treatment was to analyze all those costs and book the accrual into the December quarter, which was the quarter in which he left the company. So while not all -- that large sum didn't go out as cash, a small portion did. We've accrued it, and it will be just paid out over the year. We're paying him over a 12-month severance period.
不。會計處理是分析所有這些成本並將應計費用記入 12 月季度,即他離開公司的季度。因此,雖然不是全部——大筆資金沒有以現金形式流出,但有一小部分卻以現金形式流出。我們已經累積了這筆錢,並將在一年內支付。我們將支付他 12 個月的遣散費。
We have pretty extensive detail on that in our quarterly report 10-Q that will go on file shortly. So I'd encourage anybody that's interested in that to take a look at the footnotes.
我們在 10-Q 季度報告中對此有相當廣泛的詳細信息,該報告很快就會歸檔。因此,我鼓勵任何對此感興趣的人看一下腳註。
Marla Marin - Analyst
Marla Marin - Analyst
Got it. Okay. And then last question for me. So in order to move forward with the oncology trial, you said you need to do some pre-clinical work -- in vitro work, correct, in order to see if the plasma from cancer patients that are enrolled and being treated with anti-PD-1 treatment the response when the Hemopurifier is used. Can you just give us some color on how you get those patients involved, how you are able to obtain access to the plasma from these patients, pre-moving parts?
知道了。好的。然後是我的最後一個問題。因此,為了推進腫瘤學試驗,您說您需要做一些臨床前工作 - 體外工作,正確的,以便看看來自入組並接受抗 PD 治療的癌症患者的血漿是否-1 治療使用血液淨化器時的反應。您能否向我們介紹一下您如何讓這些患者參與進來,您如何能夠從這些患者那裡獲得血漿以及預移動部件?
Steven LaRosa - Chief Medical Officer
Steven LaRosa - Chief Medical Officer
Yes, so Marla, the kind of the work plan, if you will, for those pre-clinical studies is there are commercially available sources of plasma from cancer patients. The patients have already signed consent. So they've agreed to allow the use of this. So we've acquired plasma samples from patients with malignancy, particularly those who have been treated with anti-PD-1 therapy.
是的,所以馬拉,如果你願意的話,對於那些臨床前研究來說,工作計劃是有來自癌症患者的商業血漿來源。患者已經簽署同意書。所以他們同意允許使用這個。因此,我們採集了惡性腫瘤患者的血漿樣本,特別是那些接受過抗 PD-1 治療的患者。
We then run those over a smaller version of our Hemopurifier. And then we count things like exosomes and exosomes of PD-L1 and effects on T-cells. So we are at that, the process that we are in, and we are still working on getting a definitive answer from those studies.
然後我們在較小版本的血液淨化器上運行它們。然後我們計算外泌體和 PD-L1 外泌體以及對 T 細胞的影響。所以我們正處於這個過程中,我們仍在努力從這些研究中獲得明確的答案。
Marla Marin - Analyst
Marla Marin - Analyst
Okay, got. Thanks. Thank you so much.
好的,明白了。謝謝。太感謝了。
James Frakes - Interim CEO, CFO, SVP - Finance, Company Secretary, & Director
James Frakes - Interim CEO, CFO, SVP - Finance, Company Secretary, & Director
Thank you, Marla.
謝謝你,瑪拉。
Operator
Operator
(Operator Instructions) Anthony Vendetti, Maxim Group.
(操作員說明)Anthony Vendetti,Maxim Group。
Anthony Vendetti - Analyst
Anthony Vendetti - Analyst
Yes, thanks. So Jim, on the studies in India, just how many patients are enrolled at this point, and just -- go through again. That should help, right, bringing over those results over to the US?
對了謝謝。吉姆,關於印度的研究,目前有多少患者入組,然後再次進行。這應該有助於將這些結果帶到美國,對嗎?
Steven LaRosa - Chief Medical Officer
Steven LaRosa - Chief Medical Officer
So Anthony, the COVID study, which is the one that's open right now, we can enroll up to 15, 1-5 patients. We've enrolled one to date, but it's designed in a manner that, yes, the data, including the biomarker data would be useful for submissions to regulatory agencies. But again, the issue has been with the evolving COVID epidemic or patients who were affected who aren't critically ill. And that's the population that's eligible for the study.
安東尼,目前正在進行的新冠肺炎研究,我們最多可以招募 15 名、1-5 名患者。到目前為止,我們已經註冊了一個,但它的設計方式是,包括生物標記數據在內的數據對於向監管機構提交數據很有用。但同樣,問題在於不斷發展的新冠疫情或受到影響但病情並不危重的患者。這就是有資格參加這項研究的人群。
James Frakes - Interim CEO, CFO, SVP - Finance, Company Secretary, & Director
James Frakes - Interim CEO, CFO, SVP - Finance, Company Secretary, & Director
And the FDA prior studies in India did accept and use that data, so it's useful information.
FDA 先前在印度進行的研究確實接受並使用了這些數據,因此這是有用的信息。
Anthony Vendetti - Analyst
Anthony Vendetti - Analyst
So you said that they found that a new variant in India. Is that different then than the JN.1 in the US, the most prevalent now in the US?
所以你說他們在印度發現了一種新的變體。這與美國現在最受歡迎的 JN.1 有什麼不同嗎?
Steven LaRosa - Chief Medical Officer
Steven LaRosa - Chief Medical Officer
No. I'd say it's -- the JN.1, what they are finding is it's the predominant and they don't know what the downstream clinical consequences are going to be, meaning, is it going to translate? Is it going to translate to more hospitalized and critically ill patients? So that's an unknown right now.
不。我想說的是-JN.1,他們發現它是主要的,他們不知道下游的臨床後果是什麼,意思是,它會轉化嗎?這是否會導致更多住院和危重病患的出現?所以現在還是個未知數。
Anthony Vendetti - Analyst
Anthony Vendetti - Analyst
Okay. And then in terms of the oncology trial data, is that being done in Australia?
好的。那麼就腫瘤學試驗數據而言,這是在澳洲進行的嗎?
Steven LaRosa - Chief Medical Officer
Steven LaRosa - Chief Medical Officer
The planned studies, safety, feasibility, and akin to dose finding, how often do you have to give the Hemopurifier treatment? Those -- two individual trials are going to be -- one trial is going to be conducted in India. One's going to be conducted in Australia. Again, we're awaiting our in vitro data to submit to the ethics boards to get those studies started.
計劃的研究、安全性、可行性以及類似劑量的發現,您需要多久進行一次血液淨化器治療?這些——兩項單獨的試驗——其中一項試驗將在印度進行。其中一個將在澳大利亞進行。同樣,我們正在等待我們的體外數據提交給倫理委員會以啟動這些研究。
Anthony Vendetti - Analyst
Anthony Vendetti - Analyst
Okay. So neither of them has started at this point?
好的。那麼他們兩個都還沒開始嗎?
Steven LaRosa - Chief Medical Officer
Steven LaRosa - Chief Medical Officer
That's correct.
這是正確的。
James Frakes - Interim CEO, CFO, SVP - Finance, Company Secretary, & Director
James Frakes - Interim CEO, CFO, SVP - Finance, Company Secretary, & Director
That's correct. We are poised. I've been really pushing hard on this, Anthony, since I was named Interim CEO. And we've come a long way on the R&D efforts. They couldn't even count the extracellular PD-L1 on the extracellular vesicles two months ago. And now they can count both for total aggregates, but there have -- it's just inconclusive. That's why we're engaging outside labs to get to the bottom of exactly where we are.
這是正確的。我們已做好準備。安東尼,自從我被任命為臨時執行長以來,我一直在努力推動這一點。我們在研發工作上已經取得了長足的進步。兩個月前他們甚至無法計數細胞外囊泡上的細胞外PD-L1。現在他們可以將兩者都算作總總量,但有——這只是不確定的。這就是為什麼我們要與外部實驗室合作來弄清楚我們到底在哪裡。
Steven LaRosa - Chief Medical Officer
Steven LaRosa - Chief Medical Officer
Yes. And to reiterate Jim's point, so there's a whole -- as you can imagine, there's a whole host of activities that have to be done to start a trial. And so we've been pushing to get every one of those done so that once we have the data, we can go -- if it's a go.
是的。重申吉姆的觀點,正如你可以想像的那樣,啟動試驗需要完成一系列的活動。因此,我們一直在努力完成每一項工作,以便一旦我們獲得數據,我們就可以開始——如果可以的話。
Anthony Vendetti - Analyst
Anthony Vendetti - Analyst
Understood. Okay. And then lastly, I think you did mention, at the end of your prepared remarks, an update on the on the organ transplant progress. Is that -- maybe just give me a little more color on that. Is that -- I know the oncology is taking priority, but maybe just an update on where that's at.
明白了。好的。最後,我認為您在準備好的演講結束時確實提到了器官移植進展的最新情況。是嗎——也許只是給我更多的色彩。我知道腫瘤學是優先考慮的,但也許只是更新情況。
James Frakes - Interim CEO, CFO, SVP - Finance, Company Secretary, & Director
James Frakes - Interim CEO, CFO, SVP - Finance, Company Secretary, & Director
Well, I did push to make the oncology effort as the highest priority, but there was momentum with the organ transplant work. We have generated additional data. It's pretty interesting stuff, and we do plan to write one or more articles.
嗯,我確實推動腫瘤學工作作為最高優先事項,但器官移植工作也有動力。我們已經產生了額外的數據。這是非常有趣的東西,我們確實計劃寫一篇或多篇文章。
We have the data. We're far enough along with the oncology studies that some of the more senior people can move their head -- wrap their head around getting the articles written or trying to get those published. So we haven't stopped that work. We may very well have things to talk about on future calls on the organ transplantation front.
我們有數據。我們在腫瘤學研究方面已經取得了足夠的進展,一些資深人士可以轉移他們的注意力——把他們的注意力集中在撰寫文章或試圖發表這些文章上。所以我們還沒有停止這項工作。我們很可能在未來關於器官移植的電話會議上討論一些事情。
Anthony Vendetti - Analyst
Anthony Vendetti - Analyst
Are you still working with 34 lives on the transplant side?
您還在為34條人生做移植工作嗎?
James Frakes - Interim CEO, CFO, SVP - Finance, Company Secretary, & Director
James Frakes - Interim CEO, CFO, SVP - Finance, Company Secretary, & Director
We are. They've been busy getting their clinical trial going. We've been busy with the oncology stuff, but yes, we're still -- we have a collaboration agreement with them. And now that they -- I don't really know where they are with their [clinic's program]. They are a private company. We couldn't talk about it publicly even if new. But yes, we're still working with them. And I think the time to move forward may be coming soon. They may have gotten things going. But I don't know. It's not our business.
我們是。他們一直忙於進行臨床試驗。我們一直忙於腫瘤學方面的工作,但是,是的,我們仍然與他們簽訂了合作協議。現在他們——我真的不知道他們和他們的人在哪裡[診所的計劃]。他們是一家私人公司。即使是新的,我們也不能公開談論它。但是,是的,我們仍在與他們合作。我認為向前邁進的時機可能很快就會到來。他們可能已經讓事情進展順利了。但我不知道。這不關我們的事。
Anthony Vendetti - Analyst
Anthony Vendetti - Analyst
Okay, great. All right, guys, thanks for the update. I'll hop back in the queue.
好的,太好了。好的,夥計們,感謝您的更新。我會跳回到隊列中。
James Frakes - Interim CEO, CFO, SVP - Finance, Company Secretary, & Director
James Frakes - Interim CEO, CFO, SVP - Finance, Company Secretary, & Director
Thank you, Anthony.
謝謝你,安東尼。
Operator
Operator
Thank you. Ladies and gentlemen, this concludes the question-and-answer session. I'd like to turn the conference back over to Jim Frakes for closing remarks.
謝謝。女士們、先生們,問答環節到此結束。我想將會議轉回吉姆·弗雷克斯(Jim Frakes)致閉幕詞。
James Frakes - Interim CEO, CFO, SVP - Finance, Company Secretary, & Director
James Frakes - Interim CEO, CFO, SVP - Finance, Company Secretary, & Director
Thank you again for joining us today to discuss our quarter end results. We look forward to keeping you up to date on future calls. Bye.
再次感謝您今天加入我們討論我們的季度末業績。我們期待在未來的電話會議中為您提供最新資訊。再見。
Operator
Operator
Thank you. This concludes today's conference call. We thank you all for attending today's presentation. You may now disconnect your lines and have a wonderful day.
謝謝。今天的電話會議到此結束。我們感謝大家參加今天的演講。您現在可以斷開線路並度過美好的一天。