Aethlon Medical Inc (AEMD) 2025 Q1 法說會逐字稿

完整原文

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 fiscal first quarter 2025 earnings and corporate update conference call. (Operator Instructions) Please note this event is being recorded. I would now like to turn the conference over to Michael Miller of Rx Communications. Please go ahead.

    美好的一天,歡迎參加 Aethlon Medical 2025 財年第一季財報和公司更新電話會議。(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。請繼續。

  • Michael Miller - IR

    Michael Miller - IR

  • Thank you, operator, and good afternoon, everyone. Welcome to Aethlon Medical's fiscal first quarter 2025 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 first quarter ended June 30, 2024. If you have not seen or received Aethlon Medical's earnings release, please visit the Investors page www.aethlonmedical.com.

    謝謝接線員,大家下午好。歡迎參加 Aethlon Medical 2025 財政年度第一季財報電話會議。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 2024 年 6 月 30 日的第一個財季財務業績。如果您尚未看到或收到 Aethlon Medical 的收益發布,請造訪投資者頁面 www.aethlonmedical.com。

  • Following this introduction and the reading of the company's forward-looking statement disclaimer, 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 strategy and recent development. Mr. Frakes will then make some brief remarks on Aethlon's financials will then open up the call for the Q&A session.

    在本介紹和閱讀公司前瞻性聲明免責聲明後,Aethlon 臨時執行長兼財務長 James Frakes 和 Aethlon 首席醫療官 Steven LaRosa 博士將概述 Aethlon 策略和近期發展。然後,Frakes 先生將就 Aethlon 的財務狀況發表一些簡短的評論,然後開始問答環節。

  • 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 statements. 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 statement.

    在我將電話轉交給弗雷克斯先生之前,請注意今天發布的新聞稿以及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。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, 2024, the company's most recent quarterly 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 the 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最新季度報告(截至 2024 年 3 月 31 日的財年)表格 10-K 年度報告的「風險因素」標題下找到。 10-Q 以及該公司向美國證券交易委員會提交的其他文件中。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。

  • With that, I'll now turn the call over to Mr. James Frakes, Aethlon's Interim Chief Executive Officer and Chief Financial Officer.

    現在,我將把電話轉給 Aethlon 臨時執行長兼財務長 James Frakes 先生。

  • James Frakes - Interim Chief Executive Officer, Chief Financial Officer

    James Frakes - Interim Chief Executive Officer, Chief Financial Officer

  • Thank you, Mike. I would like to thank all of you for dialing in. This is Jim Frakes, Interim CEO and longtime CFO of Aethlon Medical. Aethlon Medical is continuing the research and clinical development of its Hemopurifier, 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, which we also refer to as extracellular vesicles may promote immune suppression and metathesis, also in life-threatening infectious diseases and in organ transplantation.

    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。Aethlon Medical 正在繼續其 Hemopurifier 的研究和臨床開發,這是一種治療性血液過濾系統,旨在結合併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(我們也稱為細胞外囊泡)方面具有潛在的應用,也可促進免疫抑制和複分解,也可用於危及生命的傳染病和器官移植。

  • Now before I turn the call over to Dr. Steven LaRosa, who will give you an update on our efforts to date on the oncology front and the milestones we just hit, and on other potential milestones that we hope to achieve later on this year, I would like to take a moment to emphasize that we are starting to achieve, the two goals that I stated were our objectives when I was appointed as interim CEO last November.

    現在,在我將電話轉給史蒂文·拉羅薩博士之前,他將向您介紹我們迄今為止在腫瘤學領域所做的努力、我們剛剛達到的里程碑,以及我們希望在今年晚些時候實現的其他潛在里程碑,我想花點時間強調一下,我們正在開始實現我去年 11 月被任命為臨時執行長時所說的兩個目標。

  • Those goals were to get the Company moving forward on our oncology indication and to reduce our expenses. As you will hear shortly, we have made measurable progress on both those fronts. I'm gratified by this progress and hope that if it continues, our shareholders will be rewarded by that progress.

    這些目標是讓公司在腫瘤適應症方面取得進展並減少開支。正如您很快就會聽到的那樣,我們在這兩個方面都取得了可衡量的進展。我對這一進展感到滿意,並希望如果這種進展繼續下去,我們的股東將從這一進展中得到回報。

  • 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. As announced on August 12, 2024, The Bellberry Human Research Ethics Committee BHREC granted full ethics approval to the Pindara Private Hospital for a safety, feasibility, and dose-finding clinical trial of the Hemopurifier in patients with solid tumors who have stable or progressive disease, during anti-PD-1 monotherapy treatment such as Merck's Keytruda, pembrolizumab ot Bristol-Myers Squibb's Opdivo, nivolumab.

    謝謝你,吉姆。正如2024 年8 月12 日宣布的那樣,Bellberry 人類研究倫理委員會BHREC 向Pindara 私立醫院授予了完全倫理批准,用於在患有穩定或進展性疾病的實體瘤患者中進行血液淨化器的安全性、可行性和劑量探索臨床試驗,在抗 PD-1 單藥治療期間,例如默沙東的 Keytruda、pembrolizumab 或百時美施貴寶的 Opdivo、nivolumab。

  • The approval is valid for one year until August 6, 2025, after which time it will be eligible for renewal. The trial will be conducted by Dr. Marco Mattos and its staff at the Pindara Private Hospital located in Queensland, Australia. Earlier on June 18, 2024, the human research Ethics Committee of the central Adelaide local health network, the CALHN granted full ethics approval for this same multicenter clinical trial. The approval is valid for three years until June 13, 2027.

    該批准的有效期為一年,截至 2025 年 8 月 6 日,此後將有資格續展。該試驗將由位於澳洲昆士蘭州 Pindara 私立醫院的 Marco Mattos 博士及其工作人員進行。早些時候,2024 年 6 月 18 日,阿德萊德中央地方衛生網路 CALHN 的人類研究倫理委員會為同一多中心臨床試驗授予了完全倫理批准。此核准有效期三年,至2027年6月13日止。

  • The trial will be conducted at this site by Professor Michael Brown and his staff that the Cancer Clinical Trials Units at CALH and Royal Adelaide Hospital and Adelaide Australia. Going forward, the next steps are to receive approval from the research governance offices at each hospital. The research governance office reviews indemnities and insurance.

    該試驗將由 Michael Brown 教授及其工作人員在 CALH 癌症臨床試驗中心、皇家阿德萊德醫院和澳洲阿德萊德進行。展望未來,下一步是獲得每家醫院研究管理辦公室的批准。研究治理辦公室審查賠償和保險。

  • Once these approvals are obtained, Aethlon in concert with our Australian contract research organization, Rescue, will conduct site initiation visits noted that's IV, after which, patient enrollment in the trial may proceed. We expect that we will be open for enrollment in mid to late September 2024.

    一旦獲得這些批准,Aethlon 將與我們的澳洲合約研究組織 Rescue 合作,進行現場啟動訪問(IV),之後即可繼續進行患者入組試驗。我們預計 2024 年 9 月中下旬開放報名。

  • We anticipate several upcoming potential value-creating milestones, including submission to the governance committee at an additional site in Australia that is under the jurisdiction of the Belberry HREC, which has already reviewed the study for the Pindara site. The timeframe for activation of this third site should be in line with the activation of the other two sites.

    我們預計即將到來的幾個潛在的價值創造里程碑,包括向 Belberry HREC 管轄下的澳洲另一個地點的治理委員會提交,該委員會已經審查了 Pindara 地點的研究。第三個站點的啟動時間範圍應與其他兩個站點的啟動時間一致。

  • We also await the response from the scientific committee at a site in India, with the expectation that that will be followed by a human research ethics committee review. As a reminder, the primary endpoint of these studies is a 9 to 18 patients, safety, feasibility and dose-finding trial, and the primary endpoint is safety. The trial will monitor any adverse events and clinically significant changes in lab tests of Hemopurifier treated patients with solid tumors, with stable or progressive disease at different treatment intervals after a two month run-in period of PD-1 antibody anti-PD-1 antibody, either Keytruda or Opdivo.

    我們也正在等待印度某個地點的科學委員會的回應,預計隨後將進行人類研究倫理委員會的審查。提醒一下,這些研究的主要終點是 9 至 18 名患者的安全性、可行性和劑量探索試驗,主要終點是安全性。該試驗將監測血液淨化器治療的實體瘤患者的實驗室測試中的任何不良事件和臨床顯著變化,這些患者在接受PD-1 抗體兩個月的磨合期後,在不同的治療間隔內病情穩定或進展。

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

    對抗 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細胞外囊泡濃度所需的血液淨化器治療次數。如果細胞外囊泡濃度的這些變化提高了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 of a subsequent efficacy and safety trial, including a premarket approval known 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後續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上市前批准(稱為 PMA 研究)。

  • Currently, only approximately 30% of patients who receive pembrolizumab or nivolumab will have lasting clinical responses to these agents. Extracellular vesicles produced by tumors had been implicated in the spread of cancers as well as the resistance to these anti-PD-1 therapies. The Aethlon Hemopurifier has been designed to bind and remove these extracellular vesicles from the bloodstream, which may improve therapeutic response rates to the anti-PD-1 therapies. In preclinical studies, the Hemopurifier has been shown to reduce the number of EV's in cancer patient plasma samples.

    目前,只有大約 30% 接受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。腫瘤產生的細胞外囊泡與癌症的擴散以及對這些抗 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 療法的治療反應率。在臨床前研究中,血液淨化器已被證明可以減少癌症患者血漿樣本中的 EV 數量。

  • The company also stands poised to address outbreaks and pandemics due to life threatening envelope viruses for which no treatment exists. We have previously demonstrated the ability of a benchtop version of the Hemopurifier combined, a number of envelope viruses have interest in in vitro experiments. These include dengue -- not limited to but include dengue, [AH51] avian influenza known as bird flu. Additionally, the company's COVID 19 trial in India remains open to enroll patients with severe COVID-19 infection who require admission to the intensive care unit. To date, one patient has been treated. The company is actively evaluating COVID-19 admissions at our sites and potential enrollment against the ongoing cost of maintaining this trial.

    該公司還準備應對因危及生命的包膜病毒而導致的疫情和流行病,目前尚無治療方法。我們之前已經展示了桌上型版本的血液淨化器的結合能力,許多包膜病毒都對體外實驗感興趣。其中包括登革熱 - 不限於但包括登革熱、[AH51] 禽流感(稱為禽流感)。此外,該公司在印度的 COVID-19 試驗仍然開放,以招募需要入住重症監護室的嚴重 COVID-19 感染患者。迄今為止,已有一名患者接受治療。該公司正在根據維持該試驗的持續成本,積極評估我們網站的 COVID-19 入院情況和潛在入院情況。

  • 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,然後提出問題。

  • James Frakes - Interim Chief Executive Officer, Chief Financial Officer

    James Frakes - Interim Chief Executive Officer, Chief Financial Officer

  • Thanks, Steve, and good afternoon again, everyone. I will try to keep my remarks on our financial discussion and at a high level. You'll find detailed expense information in the financial statements attached to our earnings release that just hit the wire or in our soon to be filed quarterly report on Form 10-Q. As of June 30, 2024, Aethlon Medical had a cash balance of approximately $9.1 million.

    謝謝史蒂夫,大家下午好。我將盡力在我們的財務討論中保持高水準的發言。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。截至 2024 年 6 月 30 日,Aethlon Medical 的現金餘額約為 910 萬美元。

  • Our consolidated operating expenses for the fiscal quarter ended June 30, 2024, were approximately $2.6 million compared to $3.4 million for the fiscal quarter ended June 2023. This decrease of approximately $800,000 or approximately 24% in the 2024 period was due to a decrease of approximately $600,000 in general and administrative expenses, and a decrease of approximately $300,000 in professional fees, partially offset by an increase in payroll and related expenses of approximately $100,000.

    截至 2024 年 6 月 30 日的財政季度,我們的綜合營運費用約為 260 萬美元,而截至 2023 年 6 月 30 日的財政季度的綜合營運費用為 340 萬美元。2024 年期間減少約 80 萬美元或約 24%,是由於一般和管理費用減少約 60 萬美元,專業費用減少約 30 萬美元,部分被薪資和相關費用增加約 10 萬美元所抵消。

  • The approximate $600,000 decrease in G&A expenses in the fiscal quarter ended June 30, 2024, was primarily due to a $447,000 decrease in supplies related to the purchase of raw materials for manufacturing of Hemopurifier and for lab supplies. The approximate $300,000 decrease in professional fees was primarily due to a $136,000 decrease in consulting expenses, primarily related to termination of services with a contract manufacturing organization, a $110,000 decrease in scientific consulting, and a $78,000 decrease in legal fees relating to general corporate matters.

    截至 2024 年 6 月 30 日的財季,一般管理費用減少了約 60 萬美元,主要是由於與購買用於製造血液淨化器和實驗室用品的原材料相關的供應減少了 447,000 美元。專業費用減少約30 萬美元,主要是由於諮詢費用減少了136,000 美元(主要與終止與合約製造組織的服務有關)、科學諮詢費用減少了110,000 美元,以及與一般公司事務相關的法律費用減少了78,000 美元。

  • The approximate $100,000 increase in payroll and related expenses was primarily due to an increase in separation expenses of approximately $300,000 related to the termination of an employee. That increase was partially offset by a decrease of $111,000 in stock-based compensation and an $89,000 decrease in general and administrative personnel expenses. As a result of the factors I just noted, Aethlon's net loss decreased by approximately $700,000 to approximately $2.6 million in the fiscal quarter ended June 30, 2024, from approximately $3.3 million in the fiscal quarter ended June 30, 2023.

    薪資和相關費用增加約 10 萬美元,主要是由於與解僱員工相關的離職費用增加約 30 萬美元。這一增長被股票薪酬減少 111,000 美元以及一般和行政人員費用減少 89,000 美元部分抵消。由於我剛才提到的因素,Aethlon 的淨虧損從截至2023 年6 月30 日的財政季度的約330 萬美元減少到截至2024 年6 月30 日的財政季度的約260 萬美元,減少了約70萬美元。

  • I'd like to note and emphasize that if we exclude the $300,000 provision related to that employee termination, our operating expenses decreased by over $1 million quarter over quarter. We included these earnings results and related commentary in a press release issued earlier this afternoon. That release included the balance sheet for June 30, 2024, and the statements of operations for the fiscal quarters ended June 30, 2024 and 2023. We will file our quarterly report on Form 10-Q following this call. Our next earnings call for the fiscal second quarter ending September 30, 2024, will coincide with the filing of our quarterly report on Form 10-Q in November 2024.

    我想指出並強調的是,如果我們排除與該員工解僱相關的 30 萬美元準備金,我們的營運費用將比上一季減少超過 100 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6月30日的資產負債表以及截至2024年6月30日和2023年6月30日的財政季度的營運報表。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 9 月 30 日結束的第二財季召開,屆時我們將在 2024 年 11 月提交 10-Q 表格季度報告。

  • 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)

    (操作員說明)

  • Marla Marin, Zacks.

    瑪拉馬林,札克斯。

  • Marla Marin - Analyst

    Marla Marin - Analyst

  • So just I wanted to -- Jim, I wanted to get back to something you just said about the operating expense. If you normalize it yellow to exclude the, payment to the former employee. And is that a good run rate going forward. Our understanding, of course, is that as soon as some of the clinical development efforts begin to ramp, we will see that reflected in higher R&D?

    所以我只是想——吉姆,我想回到你剛才所說的關於營運費用的話題。如果將其標準化為黃色以排除向前僱員付款。未來的運作率是否良好?當然,我們的理解是,一旦一些臨床開發工作開始加強,我們就會看到這反映在更高的研發中?

  • James Frakes - Interim Chief Executive Officer, Chief Financial Officer

    James Frakes - Interim Chief Executive Officer, Chief Financial Officer

  • Hi, Marla. That's a good question. We have things moving in different directions. On the expense reduction side -- and this is public information now if you look at our website and filings to all of them, we changed law firms and accounting firms, the firms that should be somewhat less expensive. So we didn't have that benefit in the June quarter. So there should be further expense reductions from those professional fees going forward.

    嗨,瑪拉。這是個好問題。我們的事情正朝著不同的方向發展。在減少費用方面——如果你查看我們的網站和向所有這些公司提交的文件,這是現在的公開信息,我們更換了律師事務所和會計師事務所,這些公司的成本應該要便宜一些。因此,我們在六月季度沒有獲得這種好處。因此,未來這些專業費用應該會進一步減少。

  • But as you noted, starting in September month to month, we expect much more activity in the Australian clinical trials. I see them some colleagues are going to fly over there at the site initiation to train the people on. So there will be additional and will probably remain higher on the clinical trial front on the expenses. So they may offset that we can perfect exactly, but they should be somewhat offsetting.

    但正如您所指出的,從 9 月開始,我們預計澳洲臨床試驗的活動將會更加頻繁。我看到一些同事將在啟動儀式上飛到那裡對人們進行培訓。因此,臨床試驗方面的費用將會增加,並且可能會保持在較高水準。所以它們可能會抵消我們可以精確完善的部分,但它們應該會有所抵消。

  • Marla Marin - Analyst

    Marla Marin - Analyst

  • So then follow-up to Steve. In terms of any kind of training that you have to provide, do you expect that to be a relatively short term process? And how will you provide support once you've when you return back to the state?

    接下來是史蒂夫的後續行動。就您必須提供的任何類型的培訓而言,您是否認為這是一個相對短期的過程?當您返回該州後,您將如何提供支援?

  • Steven Larosa - Chief Medical Officer

    Steven Larosa - Chief Medical Officer

  • No, great question. Thank you, Marla. So on as I mentioned, the research governance approvals on both of that review process is underway. We've already got the site initiation visits at those two sites scheduled in September. Provided the governance goes, okay, once you're done with the site initiation visits, which my colleagues get up on, will participate in virtually, those sites can actually begin screening and enrolling patients. So that's kind of the on switch. That will be followed by a site investigator meeting in the October time frame, which will actually travel to Australia, and we would all the personnel at the sites. But those sites will already be -- the two sites will already be opened for our enrollment by then.

    不,很好的問題。謝謝你,瑪拉。正如我所提到的,這兩個審查過程的研究治理批准正在進行中。我們已經安排在 9 月對這兩個地點進行現場啟動訪問。如果治理順利的話,一旦你完成了站點啟動訪問(我的同事們開始進行虛擬參與),這些站點實際上就可以開始篩選和招募患者。這就是開關。隨後將在 10 月召開現場調查員會議,會議實際上將前往澳大利亞,我們將與現場的所有人員會面。但到那時,這些網站已經開放供我們註冊。

  • At both the site initiation visit time frame and the investigator meeting timeframe, there will be lots of technical training on the actual device. And then we are also in the phase now of interviewing people as it is for a technical position at Aethlon who would provide real-time assistance through those trials, so that actually be boots on the ground if you will, to help the sites. So yeah, they'll be -- my colleague and I here who will be available, of course, at all times for any patient that's enrolled.

    在現場啟動訪問時間和研究者會議時間範圍內,都會有大量針對實際設備的技術訓練。然後我們現在也處於面試人員的階段,因為這是 Aethlon 的技術職位,他們將透過這些試驗提供即時幫助,所以如果你願意的話,實際上是在現場幫助這些網站。所以,是的,他們將是——我和我的同事,當然,他們將隨時為任何登記的患者提供服務。

  • Marla Marin - Analyst

    Marla Marin - Analyst

  • Okay. Thank you. And then last question, it's really more of a housekeeping question. I just want to make sure that I'm understanding what you said in your prepared remarks as far as like the paperwork at your end, you have completed all of the paperwork from that you needed to submit?

    好的。謝謝。最後一個問題,這實際上更像是一個家務問題。我只是想確保我理解您在準備好的演講中所說的內容,就像您最後的文件一樣,您已經完成了需要提交的所有文件嗎?

  • Steven Larosa - Chief Medical Officer

    Steven Larosa - Chief Medical Officer

  • We had for both the ethics committees. You know, we had a paperwork that had to be submitted and responses. And so we're through that phase. And now we've provided our CRO rescue with all the paperwork that they need from our end for the for the governance review, yes, we've done all. We've done everything we could do. We're waiting for the governance offices at those two sites to rule.

    我們有兩個道德委員會。你知道,我們有一份必須提交和回覆的文件。我們已經經歷了這個階段。現在,我們已經向 CRO 救援人員提供了他們需要的所有文件,以進行治理審查,是的,我們已經完成了所有工作。我們已經做了我們所能做的一切。我們正在等待這兩個地點的管理辦公室做出裁決。

  • Marla Marin - Analyst

    Marla Marin - Analyst

  • Okay, great, thank you.

    好的,太好了,謝謝。

  • James Frakes - Interim Chief Executive Officer, Chief Financial Officer

    James Frakes - Interim Chief Executive Officer, Chief Financial Officer

  • And again, of those are just kind of straightforward business issues. We're selling them. Our insurance policies, we've signed indemnities. I think they've even counter sign. Some of them are tracking on appeal.

    再說一遍,這些只是一些簡單的商業問題。我們正在出售它們。我們的保險單,我們已經簽署了賠償。我認為他們甚至還反對簽名。其中一些人正在追蹤上訴。

  • Steven Larosa - Chief Medical Officer

    Steven Larosa - Chief Medical Officer

  • Agreed-upon budget.

    商定的預算。

  • James Frakes - Interim Chief Executive Officer, Chief Financial Officer

    James Frakes - Interim Chief Executive Officer, Chief Financial Officer

  • Budgets are agreed upon. So it's not a straightforward business family served to nail down.

    預算已商定。因此,這不是一個簡單的商業家族就能確定的。

  • Marla Marin - Analyst

    Marla Marin - Analyst

  • Got it, thank you.

    明白了,謝謝。

  • Operator

    Operator

  • (Operator Instructions)

    (操作員說明)

  • This concludes our question-and-answer session. I would like to turn the conference back over to Jim Frakes for any closing remarks.

    我們的問答環節到此結束。我想將會議轉回吉姆·弗雷克斯(Jim Frakes)發表閉幕詞。

  • James Frakes - Interim Chief Executive Officer, Chief Financial Officer

    James Frakes - Interim Chief Executive Officer, Chief Financial Officer

  • Thank you, operator, and thank you again, everybody for joining us today to discuss our first fiscal quarter results. We're pleased that we're making progress, and we look forward to keeping you up to date on future calls.

    謝謝運營商,再次感謝大家今天加入我們討論我們的第一財季業績。我們很高興我們正在取得進展,並期待在未來的通話中向您通報最新情況。

  • Operator

    Operator

  • The conference has now concluded. Thank you for attending today's presentation. You may now disconnect.

    會議現已結束。感謝您參加今天的演講。您現在可以斷開連線。