Aethlon Medical Inc (AEMD) 2025 Q3 法說會逐字稿

(technical difficulty) October 2024 both in addition to my long-term role as CFO, I announced that I would focus the efforts of the company on oncology and on reducing operating expenses.

（技術難題）2024 年 10 月，除了長期擔任財務長之外，我還宣布將把公司的精力集中在腫瘤學和降低營運費用上。

I am pleased to cover the highlights of the December 2024 quarter and subsequent events to date to discuss how the results of that focus are really starting to show. I'm gratified by this progress and expect that our shareholders ultimately will be rewarded by our efforts. Dr. Steven LaRosa, our Chief Medical Officer, will now give an update on our oncology trial efforts and then I will touch on our financials, including the improvements in operating efficiencies. Steve?

我很高興報導 2024 年 12 月季度的亮點以及迄今為止的後續事件，以討論這一重點的成果如何真正開始顯現。我對這一進展感到欣慰，並期望我們的股東最終能夠因我們的努力而獲得回報。我們的首席醫療官 Steven LaRosa 博士現在將介紹我們的腫瘤學試驗工作的最新進展，然後我將談到我們的財務狀況，包括營運效率的提高。史蒂夫？

Thank you, Jim. Steady progress has been made in our Australian oncology trial of the Hemopurifier in patients with solid tumors. To date, three patients have been enrolled. Two patients did not advance to the Hemopurifier treatment phase of the study due to prespecified stopping criteria during the two-month running period. One had showed a clinical response to anti-PD-1 therapy alone while the other experienced toxicity to the anti-PD-1 agent.

謝謝你，吉姆。我們在澳洲針對實體瘤患者進行的血液淨化器腫瘤學試驗取得了穩定進展。迄今為止，已有三名患者入組。在兩個月的運行期內，兩名患者因預先指定的停止標準而未能進入研究的血液淨化器治療階段。其中一例患者單獨接受抗 PD-1 療法後出現臨床反應，另一例患者則對抗 PD-1 藥物產生毒性。

A third patient who did not respond to the anti-PD-1 therapy, completed a four-hour Hemopurifier treatment at Royal Adelaide Hospital on January 29, 2025. The treatment was completed with no device-related issues or immediate complications. At the prespecified day seven safety follow-up visit conducted on February 4, 2025, the patient was noted to not have experienced any adverse events and did not have any clinically significant changes in the safety laboratory measurements.

第三位對抗 PD-1 療法沒有反應的患者於 2025 年 1 月 29 日在皇家阿德萊德醫院完成了四小時的血液淨化器治療。治療完成時沒有出現任何與設備相關的問題或直接併發症。在 2025 年 2 月 4 日進行的預定第七天安全追蹤中，患者未出現任何不良事件，且安全實驗室測量結果也未出現任何臨床顯著變化。

Samples were also collected before and after Hemopurifier treatment to be analyzed for extracellular vesicle removal and changes in antitumor T-cell numbers by the device. This data will be available once all three patients in this patient cohort are treated. Once the seven-day safety follow-up period has been completed on the three patients in this first study cohort, an independent data safety monitoring board, known as the DSMB will convene regarding advancing to the second cohort where patients will get two Hemopurifier treatments during a given week.

在血液淨化器治療前後也收集了樣本，以分析該裝置去除細胞外囊泡的情況和抗腫瘤 T 細胞數量的變化。一旦該患者群體中的所有三名患者都接受治療，即可獲得這些數據。一旦對第一組研究對像中的三名患者完成為期七天的安全追蹤期，一個獨立的資料安全監測委員會（DSMB）將召開會議，討論是否進入第二組研究，第二組患者將在一周內接受兩次血液淨化器治療。

Following the investigator meeting with the three clinical sites, Aethlon received valuable feedback from the sites suggesting protocol modifications that could possibly improve enrollment speed, reduce screen failures, shorten the time to Hemopurifier treatments and the time to data. In response, the Aethlon team swiftly developed a protocol amendment incorporating these recommendations.

在研究人員與三個臨床站點會面後，Aethlon 從這些站點獲得了寶貴的回饋意見，建議修改協議，這可能會提高入組速度，減少篩檢失敗，縮短血液淨化器治療時間和資料獲取時間。作為回應，Aethlon 團隊迅速制定了納入這些建議的協議修正案。

Key changes made in the amendment included enrolling patients only after they've been confirmed to not be responding to anti-PD-1 therapy. This adjustment eliminates the need to identify patients within the first two weeks of starting anti-PD-1 therapy while also removing the two-month run-in period previously required to assess response to therapy.

修正案中的關鍵變化包括僅在確認患者對抗 PD-1 療法沒有反應後才招募患者。此項調整消除了在開始抗 PD-1 治療後的前兩週內識別患者的需要，同時也取消了先前評估治療反應所需的兩個月的導入期。

Additionally, restrictions on commonly prescribed concomitant medications that would not impact patient safety were lifted. The amended protocol also broadens eligibility to include patients receiving all approved dosing regimens of pembrolizumab and nivolumab, rather than limiting enrollment to patients on specific schedules of those medications.

此外，對不會影響病人安全的常用伴隨藥物的限制也被取消。修訂後的方案還擴大了入選資格，將接受所有經批准的 pembrolizumab 和 nivolumab 給藥方案的患者納入其中，而不是將入選範圍限制在按照特定時間表服用這些藥物的患者身上。

The company is pleased to announce that the Human Research Ethics Committee, known as HREC and Research Governance Offices known as RGO have all approved this amendment at all three sites. The two currently active sites, Royal Adelaide Hospital and Pindara Private Hospital can enroll under this amended protocol presently. The third site, Genesis Care Royal North Shore Hospital, can begin enrollment under this amendment following a site initiation visit to be conducted this week, on February 14, 2020.

該公司很高興地宣布，人類研究倫理委員會（HREC）和研究管理辦公室（RGO）均已在三個地點批准了此項修正案。目前活躍的兩個站點，皇家阿德萊德醫院和平達拉私立醫院，目前可根據此修訂協議進行登記。第三個地點 Genesis Care Royal North Shore Hospital 將於本週（2020 年 2 月 14 日）進行現場啟動訪問後，根據該修正案開始招募患者。

The company continues to pursue approval of a similarly designed clinical trial in India. HREC approval has been obtained at Medanta Medicity Hospital, and we are currently awaiting approval from the regulatory agency, CDSCO in India. Recent regulatory changes in India have introduced additional documentation requirements that were previously not necessary. Aethlon is actively responding to CDSCO's queries through the company's India CRO Qualtran. As a reminder, the primary endpoint of the approximate nine to 18-patient, safety, feasibility and dose-finding trial is safety.

該公司繼續尋求在印度批准類似設計的臨床試驗。Medanta Medicity 醫院已獲得 HREC 批准，目前正在等待印度監管機構 CDSCO 的批准。印度最近的監管變化引入了以前不必要的額外文件要求。Aethlon 正在透過該公司的印度 CRO Qualtran 積極回應 CDSCO 的詢問。提醒一下，大約 9 到 18 名患者的安全性、可行性和劑量探索試驗的主要終點是安全性。

The trial will monitor any adverse events and clinically significant changes in labs of the Hemopurifier treated patients with solid tumors who have stable or progressive disease at different treatment intervals after a 2-month run-in period of anti-PD-1 therapy, either Keytruda or Opdivo.

該試驗將監測接受 Hemopurifier 治療的實體瘤患者的任何不良事件和實驗室臨床顯著變化，這些患者在接受抗 PD-1 療法（Keytruda 或 Opdivo）的 2 個月磨合期後，病情穩定或出現進展，並且會在不同的治療間隔內出現這些變化。

Patients who don't respond to the anti-PD-1 therapy will be eligible to enter the Hemopurifier 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 verticals, EVs and if these changes in EV concentrations improves the body's own natural ability to attack tumor cells.

對抗 PD-1 療法沒有反應的患者將有資格參加 Hemopurifier 研究，其中連續隊列將在一周內接受一、二或三次 Hemopurifier 治療。除了監測安全性之外，該研究還旨在檢查降低細胞外垂直細胞膜 (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 of a subsequent efficacy and safety trial, including a premarket approval study known as the PMA study required by the FDA and other regulatory agencies. Currently, only approximately 30% of patients who received pembrolizumab or nivolumab will have a lasting clinical response to these agents. Extracellular vesicles produced by tumors have been implicated in the spread of the cancers as well as the resistance to anti-PD-1 therapy.

這些探索性的中心實驗室分析有望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研究（即 PMA 研究）。目前，接受 pembrolizumab 或 nivolumab 治療的患者中只有約 30% 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抗 PD-1 療法的抗藥性有關。

The Aethlon Hemopurifier has been designed to bind and remove these EVs from the bloodstream, which may improve therapeutic response rates to anti-PD-1 antibodies. In preclinical studies, the Hemopurifier has been shown to reduce the number of EVs in cancer patient plasma samples.

Aethlon 血液淨化器旨在結合並從血液中去除這些 EV，這可能會提高對抗 PD-1 抗體的治療反應率。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 is closely monitoring developments related to bird flu in the United States, Marburg virus in Rwanda and Ebola virus in Uganda. Aethlon has direct experience with these viruses having previously generated in vitro viral binding data for all three viruses, and treated an Ebola patient in Germany under emergency use conditions. Aethlon will continue to monitor these situations carefully and be poised to respond if currently available treatment strategies are deemed ineffective.

該公司正密切關注美國禽流感、盧安達馬堡病毒和烏幹達伊波拉病毒的動態。Aethlon 對這些病毒有直接的經驗，之前曾為這三種病毒產生過體外病毒結合數據，並在緊急使用條件下在德國治療過一名伊波拉患者。Aethlon 將繼續密切監測這些情況，如果目前的治療策略被認為無效，我們將做好準備做出反應。

Finally, we have previously disclosed that we received samples from patients with Long COVID through the link, known as the long-term impact of infection with novel coronavirus study cohort at the University of California San Francisco Medical Center. EVs, including those containing SARS-CoV-2 have been implicated in the pathogenesis and the resulting symptoms seen in Long COVID. Our research team has been testing these Long COVID samples to see if the proprietary G&A resin in our Hemopurifier binds the EVs in these patient samples. We plan to share this data in the future.

最後，我們先前曾披露，我們透過連結收到了來自長期 COVID 患者的樣本，該連結被稱為加州大學舊金山醫學中心的新型冠狀病毒感染的長期影響研究隊列。EVs，包括含有 SARS-CoV-2 的 EVs，與 Long COVID 的發病機制和由此產生的症狀有關。我們的研究團隊一直在測試這些 Long COVID 樣本，以查看我們的血液淨化器中專有的 G&A 樹脂是否能與這些患者樣本中的 EVs 結合。我們計劃將來分享這些數據。

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

說完這些，我會把電話轉回給吉姆討論財務問題，然後他會回答大家的提問。

Great. Thanks, Steve, and good afternoon again, everyone. Now on to the financial portion of our remarks. Aethlon has implemented strategic cost-cutting measures to optimize company resources enabling us to maintain a strong focus on the high-impact oncology trials in both Australia and India. These initiatives are designed to improve resource allocation, reduce operational expenses, and support the continued advancement of our clinical programs.

偉大的。謝謝，史蒂夫，大家下午好。現在談談我們評論的財務部分。Aethlon 實施了策略性削減成本措施，以優化公司資源，使我們能夠將重點放在澳洲和印度的高影響力腫瘤學試驗。這些措施旨在改善資源分配、降低營運費用並支持我們的臨床計畫持續推進。

I will keep our financial overview brief with a focus on key points. For a more detailed analysis, you can refer to 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.

我將簡要介紹我們的財務概況，重點在於重點。如需更詳細的分析，您可以參考我們剛發布的收益報告所附的財務報表或我們即將提交的 10-Q 表季度報告。

As of December 31, 2024, Aethlon had a cash balance of approximately $4.8 million. Our consolidated operating expenses for the fiscal quarter ended December 31, 2024 decreased by approximately $1.8 million or approximately 50% to $1.8 million compared to $3.6 million for the fiscal quarter ended December 31, 2023. This reduction was driven by a $1.3 million decrease in payroll and related expenses, a $300,000 decrease in professional fees and a $200,000 decrease in general and administrative expenses or G&A expenses.

截至 2024 年 12 月 31 日，Aethlon 的現金餘額約為 480 萬美元。截至 2024 年 12 月 31 日的財政季度，我們的綜合營運費用減少了約 180 萬美元，約 50%，至 180 萬美元，而截至 2023 年 12 月 31 日的財政季度為 360 萬美元。減少的原因是工資和相關費用減少 130 萬美元、專業費用減少 30 萬美元以及一般和行政費用或 G&A 費用減少 20 萬美元。

The approximate $1.3 million decrease in payroll and related expenses was primarily attributable to a reduction of $900,000 in separation expenses related to the separation agreement with our former CEO that has been recorded in the December 2023 period as well as a decrease of approximately $400,000 due to a reduction in head count. Of the approximate $900,000 of separation expenses related to the departure of the former CEO, approximately $400,000 related to the acceleration of vesting of stock options.

薪資和相關費用減少約 130 萬美元，主要原因是與我們前任執行長達成的離職協議相關的離職費用減少了 90 萬美元（該費用已記錄在 2023 年 12 月期間），以及由於員工人數減少而減少了約 40 萬美元。在與前任執行長離職有關的約 90 萬美元的離職費用中，約 40 萬美元與加速股票選擇權歸屬有關。

The approximate $300,000 decrease in professional fees was primarily due to an approximate reduction of $200,000 in legal fees resulting from the transition to a new legal firm and a decrease of $200,000 in scientific and operational consulting fees, largely attributable to completed projects. These decreases were partially offset by an approximate $100,000 increase in Investor Relations and accounting fees. The approximate $200,000 decrease in G&A expenses was primarily driven by a $300,000 reduction in supplies, largely related to the raw materials and components used in the manufacturing of the Hemopurifier with no comparable purchases during the current period.

專業費用減少約 30 萬美元，主要是因為轉入新的律師事務所導致法律費用減少約 20 萬美元，以及科學和營運諮詢費用減少 20 萬美元，這主要歸因於已完成的項目。這些減少被投資者關係和會計費用約 10 萬美元的增加部分抵消。一般及行政費用減少約 20 萬美元，主要是由於供應品減少 30 萬美元，這主要與製造血液淨化器所使用的原材料和部件有關，而本期間沒有可比採購。

Additionally, there was an approximate $100,000 decrease in insurance expenses associated with the reduced head count and various other operating expenses. These reductions were partially offset by a $200,000 increase in clinical trial expenses related to our ongoing clinical trials in Australia and India. As a result of the factors I just noted, our net loss decreased to approximately $1.8 million in the fiscal quarter ended December 31, 2024, from approximately $3.5 million in the fiscal year ended December 31, 2023.

此外，由於員工人數減少，保險費用和其他各種營運費用也減少了約 10 萬美元。這些減少的部分被我們在澳洲和印度正在進行的臨床試驗相關的臨床試驗費用增加 20 萬美元所抵消。由於我剛才提到的因素，我們的淨虧損從截至 2023 年 12 月 31 日的財政年度的約 350 萬美元減少至截至 2024 年 12 月 31 日的財政季度的約 180 萬美元。

We included these earnings results and related commentary in our press release issued this afternoon. The release also included the balance sheet for December 31, 2024, and the statements of operations for the three- and nine-month periods ended December 31, 2024, and 2023. We will file our quarterly report on Form 10-Q following this call. Our next earnings call for the fiscal year ending March 31, 2025, will coincide with the filing of our annual report on Form 10-K in June 2025.

我們在今天下午發布的新聞稿中包含了這些收益結果和相關評論。新聞稿還包括 2024 年 12 月 31 日的資產負債表以及截至 2024 年 12 月 31 日和 2023 年 12 月 31 日的三個月和九個月期間的經營報表。本次電話會議結束後，我們將提交 10-Q 表季度報告。我們下一次關於截至 2025 年 3 月 31 日的財政年度的收益電話會議將與我們 2025 年 6 月提交 10-K 表年度報告的時間一致。

And now, Steve and I would 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你們的任何問題。接線員，請打開電話詢問。

(Operator Instructions) Marla Marin, Zacks.

（操作員指示） Marla Marin，Zacks。

So I would like -- I'm wondering if we can get a little bit more color on the first three patients enrolled in the study. So the study is expected to ultimately enroll 9 to 18 participants. Correct?

所以我想知道我們是否可以對參與這項研究的前三名患者有更多的了解。因此研究預計最終將招募 9 至 18 名參與者。正確的？

Marla, well -- sorry, go ahead. Please continue.

瑪拉，嗯——抱歉，請說。請繼續。

So the fact that two of the people who had been enrolled did not proceed to treatment. I'm wondering whether the range there of the 9 to 18 means that you won't lose any -- there's no opportunity cost in terms of gathering data for support of Hemopurifier treatment because you can move closer to that 18 number? Or is that not the right way to look at it?

事實是，兩名參加試驗的人並未接受治療。我想知道 9 到 18 之間的範圍是否意味著您不會失去任何東西——在收集支持血液淨化器治療的數據方面沒有任何機會成本，因為您可以更接近 18 這個數字？或者這不是正確的看待它的方式？

No. The 9 to 18 Marla refers to 19 -- 9 to 18 Hemopurifier treated patients. So to date, we only have one Hemopurifier treated patients. Those two patients still provide valuable information about T cells and EVs over the course of their run-in period. So it's valuable data.

不。9 至 18 Marla 指的是 19——9 至 18 名接受血液淨化器治療的患者。因此到目前為止，我們只有一位使用血液淨化器治療的患者。這兩名患者在磨合期內仍提供有關 T 細胞和 EV 的寶貴資訊。所以這是很有價值的數據。

But to your question, you have to have 9 to 18 Hemopurifier-treated patients. It could be as few as nine if none experience serious adverse event related to the device or a dose-limiting toxicity. So it could be just three in each patient cohort or nine, but they have to be treated with the device.

但對於您的問題，您必須有 9 至 18 名接受血液淨化器治療的患者。如果沒有人經歷與該設備相關的嚴重不良事件或劑量限制性毒性，那麼人數可能只有九人。因此，每個患者群體中可能只有三人或九人需要使用該設備進行治療。

Okay. So essentially, the two that did proceed, there's no data from them and almost as if they -- you just have to add two other people at some point to that cohort.

好的。因此，從本質上講，對於這兩個確實進行過的人，沒有他們的數據，就好像他們一樣——你只需要在某個時候將另外兩個人添加到該群體中。

That's correct.

沒錯。

Okay. Got it. Good.

好的。知道了。好的。

And Marla, following up on your question, the new protocol that Steve described that eliminates the two-month run-in period and only patients that are failing or are neutral on their anti-PD-1 therapy, Keytruda or Opdivo, it should simplify things. So the two-month run-in period goes away. So the ones that qualify will be eligible.

瑪拉，關於你的問題，史蒂夫描述的新方案消除了兩個月的導入期，並且只針對對抗 PD-1 療法 Keytruda 或 Opdivo 治療失敗或療效中立的患者，這應該會簡化事情。因此兩個月的磨合期就消失了。因此符合條件的人將有資格。

There won't be any drop -- anybody screened that goes through screening will go right into Hemopurifier treatment.

不會有任何下降——任何經過篩檢的人都會直接接受血液淨化器治療。

Got it. Right. Yes, that's understood. And will this new protocol will that also inform the trial design once you launch the trial in India?

知道了。正確的。是的，明白了。一旦在印度啟動試驗，這個新協議是否也會為試驗設計提供資訊？

Yes. We're going to -- we're actually are submitting the same -- I mean, they haven't started in India. So we have the ability to submit that same amendment to the ethics committee there, and we're doing that. So yes, they'll do the same exact study. So again, the thing is there's looser requirements with respect to concomitant meds and dosing intervals, et cetera, and you get rid of the two-month run-in period.

是的。我們將會——我們實際上正在提交同樣的文件——我的意思是，他們還沒有在印度開始。因此，我們有能力向那裡的道德委員會提交同樣的修正案，我們正在這樣做。是的，他們會做完全相同的研究。因此，再次強調，對於伴隨用藥和給藥間隔等的要求更加寬鬆，並且可以擺脫兩個月的磨合期。

So you shorten the time to Hemopurifier treatment and the hopefully, the time to data as well.

因此，您可以縮短血液淨化器治療的時間，並且希望也可以縮短獲取數據的時間。

Right. Okay. Got it. And then my last question on this. This is for you, Jim. The roughly $200,000 increase in expenses related to clinical trial expenses on the portion that is related to Australia, I'm thinking that perhaps that's the greater percentage of that $200,000 was related to Australia. You do expect to get 43% back on that portion. Is that correct?

正確的。好的。知道了。這是我對此的最後一個問題。這是給你的，吉姆。與澳洲有關的臨床試驗費用增加了約 20 萬美元，我想這 20 萬美元中與澳洲有關的佔比可能更大。您確實希望獲得該部分 43% 的回報。對嗎？

That's correct. I mean it's the vast majority related to Australia. And yes, any life science-oriented work in Australia, we can apply for that 43% tax rebate, which is a cash rebate, not a tax credit, is cash. So that's one of many reasons we're doing it in Australia, great science, great scientists, great doctors, but also there's a very attractive element that they have going for them.

沒錯。我的意思是絕大多數都跟澳洲有關。是的，在澳洲從事任何生命科學導向的工作，我們都可以申請 43% 的退稅，這是現金退稅，而不是稅收抵免，是現金。這就是我們在澳洲進行這項工作的眾多原因之一，他們擁有偉大的科學、偉大的科學家、偉大的醫生，而且他們還擁有非常有吸引力的因素。

Right. And would you please just remind us of the timing of that? When you --

正確的。您能提醒我們一下時間嗎？當你--

It's an annual submission. I think we do it in the June quarter. Our fiscal year end is March 31, as you know. So that's also the fiscal year-end for our Australian subsidiary. So it's after we conclude the books for the subsidiary. So it might be May, June -- and we might receive the money well after that.

這是一份年度提交。我認為我們會在六月季度完成這件事。如您所知，我們的財政年度結束於 3 月 31 日。這也是我們澳洲子公司的財政年度結束。這是我們完成子公司帳簿之後的事。所以可能是五月、六月——我們可能在那之後才能收到錢。

Anthony Vendetti, Maxim Group.

安東尼·文德蒂（Anthony Vendetti），馬克西姆集團（Maxim Group）。

So you have two sites activated. The third site is supposed to be activated this month. It hasn't been activated yet, right? So it's going to -- you're expecting it any week now, right?

因此您已啟動兩個網站。第三個站點預計將於本月啟用。還沒激活吧？所以它將會——您現在預計它將於下週發生，對嗎？

We will do what's called the site initiation visit on our Thursday, which is Friday in Australia. So it's dated the 14. Within a day to two days, they will be fully active to enroll patients, recruit and enroll, yes.

我們將在星期四（澳洲時間為星期五）進行所謂的現場啟動訪問。所以它的日期是 14 日。在一到兩天內，他們就會全力招募病人，招募和招生，是的。

And the hospital is located in Sydney.

該醫院位於悉尼。

It's the largest facility in North Sydney, Royal North Shore Hospital, so they have a huge patient pool with, Stephen Clarke, who is a well-regarded successful investigator. So we have great -- it's been a bureaucratic process, but we're through that. So we have high confidence in actually the team and think that they'll be able to draw from a large patient base.

皇家北岸醫院是北雪梨最大的醫療機構，因此他們擁有大量的患者，其中包括備受推崇的成功研究員 Stephen Clarke。所以，我們做得很好——這是一個官僚程序，但我們已經完成了。因此，我們對這個團隊非常有信心，並相信他們能夠從龐大的患者群體中招募人才。

Okay. That's great. Okay. So it's the largest hospital in Sydney, North Shore Hospital. That's great. So do you believe that with that third site activated in Sydney that the pace at which you could sign up, it sounds like the pace at which you could sign up patients should accelerate once that hospital is activated, right?

好的。那太棒了。好的。它是雪梨最大的醫院，北岸醫院。那太棒了。那麼，您是否認為，隨著雪梨第三個站點的啟用，報名的速度應該會加快，聽起來，一旦該醫院啟用，報名患者的速度應該會加快，對嗎？

Well, we think that, yes, they have a huge patient pool and they're a seasoned group. So we think that, coupled with the fact that the previous two sites, which are active and have amendment approval, they are already screening. So we think all three of those factors should increase enrollment, yes.

嗯，我們認為，是的，他們擁有龐大的患者群體，而且他們是一群經驗豐富的人。因此我們認為，再加上先前兩個已經活躍並且已經獲得修訂批准的站點，它們已經在進行篩選。所以我們認為這三個因素都應該會增加入學率，是的。

No. So based on that, I know it's obviously based on patient population and so forth. But internally, do you have a sort of expectation when you can get to that to 9 to 18 patient population? Is it by the end of calendar '25, hopefully sooner? How do you look at that?

不。因此基於此，我知道這顯然是基於患者族群等等。但在內部，您是否對能夠涵蓋 9 至 18 名患者群體有某種期望？是在 25 年底前嗎，希望能更早？您怎麼看待這個？

Yes. I don't have specific estimations what one would hope for sites usually estimate a patient per month. But again, anything would be an estimate.

是的。我沒有具體的估計，人們希望網站通常估計每月一名患者的費用。但同樣，任何事情都只是一個估計。

We're in February, so you would hope you would see a few patients over the next couple of months that we would get through. We get through that first cohort, which is the first big inflection point in that kind of time frame.

現在是二月，所以你希望在接下來的幾個月裡能看到我們接診的幾位病人。我們完成了第一批任務，這是這個時間範圍內的第一個重大轉折點。

Okay, okay. And then switching gears, I know you made some comments about some of the other viruses, and I know you've treated Ebola before, but I guess the one that seems to present the nearest term opportunity as we continue to learn about new bird flu cases, whether it's livestock or different chickens and so forth throughout the United States and some of those have been, at least for the farmers that have been treating or interacting with some of this livestock, they have contracted bird flu.

好的，好的。然後換個主題，我知道您對其他一些病毒發表了一些評論，我也知道您以前治療過伊波拉病毒，但我想，隨著我們繼續了解新的禽流感病例，似乎最有可能出現的是伊波拉病毒，無論是美國各地的牲畜還是不同的雞等等，其中一些人，至少對於治療或與這些牲畜接觸的農民來說，已經感染了禽流感。

I know you've treated Ebola, but have you treated any bird flu cases and what do you think the potential opportunity? You said any current procedures are exhausted, you could be a backup. But do you think that with bird flu there's an opportunity to be -- since -- as far as I know, there's not any other way to treat it. So I'm not sure if there is a first-line defense. But is there an opportunity for the Hemopurifier to be a first-line potential treatment?

我知道您治療過伊波拉病毒，但您治療過禽流感病例嗎？您認為潛在的機會是什麼？您說任何當前程序都已用盡，您可以作為後援。但是您是否認為，對於禽流感，存在著一種治療機會——因為——據我所知，沒有其他方法可以治療它。所以我不確定是否存在第一道防線。但是血液淨化器是否有機會成為第一線潛在治療方法？

That's a great question. First I'd be remiss if I didn't say I misspoke about Marburg virus, I meant to say Tanzania, it's not Rwanda, Tanzania, so I just want to clear up that. But to answer your question about bird flu. So the current treatment strategy for people who actually acquire -- humans who acquire bird flu is Oseltamivir which is Tamiflu. However, there are some things that give one pause, right, about the long-term success there that things we're seeing.

這是一個很好的問題。首先，如果我不說我對馬爾堡病毒說錯了話，那我就太失職了，我的意思是說坦尚尼亞，而不是盧安達，坦尚尼亞，所以我只是想澄清一下。但要回答你關於禽流感的問題。因此，對於感染禽流感的人，目前的治療策略是使用奧司他韋，也就是達菲。然而，有些事情讓人對我們所看到的長期成功感到擔憂。

There's recently been identified viruses in humans and in cattle that have mammalian adaptations. That means the virus has mutated such that it's more apt to be transmitted to mammals, including humans. So that's a concern. There have been previous reports of Oseltamivir resistance. So that could be an evolving issue.

最近有研究發現，人類和牛體內存在著具有哺乳動物適應性的病毒。這意味著病毒已經發生變異，更容易傳播給包括人類在內的哺乳動物。所以這是一個令人擔憂的問題。之前曾有關於奧司他韋抗藥性的報告。所以這可能是個不斷發展的問題。

And then most recently, there was actually a cattle to human transmission, which is the first time that that's actually been described. So there are some concerning things going on. I think currently, when you listen to CDC and IDSA webinars, the party line is still -- first-line treatment is Oseltamivir, particularly in people in the hospital, those who aren't improving is to send samples off for resistance testing. And it's an evolving story. We'll have to see where it goes.

最近，實際上出現了由牛傳播給人的現象，這是首次有報導描述此類現象。因此，有一些令人擔憂的事情正在發生。我認為目前，當您收聽 CDC 和 IDSA 網路研討會時，黨的路線仍然是——一線治療是奧司他韋，特別是對於住院患者，那些沒有好轉的患者，要送去樣本進行抗藥性測試。這是一個不斷發展的故事。我們得看看它會走向何方。

As it currently stands, the Hemopurifier would not be a first line treatment. But if things go south, it would be something that we'd have to respond to what the regulatory agencies say about experimental therapy. You also asked, has anybody been treated with bird flu with the Hemopurifier, any human. The answer is no. We only have in vitro studies.

就目前情況而言，血液淨化器不會成為第一線治療方法。但如果情況惡化，我們就必須對監管機構關於實驗療法的說法做出回應。您還問過，是否有人用血液淨化器治療過禽流感，有人嗎？答案是否定的。我們只有體外研究。

Okay. Yes. No, that's helpful. And then is probably more for Jim, but you significantly brought down expenses versus last year approximately cut in half and definitely even from earlier this year, they've gone down to this -- that's the question really, is this $1.8 million sort of the new run rate we should look at in terms of OpEx? Or as you enroll more of these patients, should that tick up a little bit from here?

好的。是的。不，這很有幫助。對於吉姆來說，可能還要更多，但與去年相比，你們大幅降低了開支，大約減少了一半，甚至從今年早些時候開始，開支已經降到了這個水平——這真的是個問題，從運營支出的角度來看，180 萬美元是否是我們應該考慮的新運行率？或者隨著您招募更多這樣的患者，這種情況是否應該從現在開始增加？

Well, this is Jim, Anthony. I do expect G&A expenses to increase ramp up as the clinical trial in Australia and then India continue progressing, it will go up. We're going to try to hold the line on professional fees and payroll to the extent we can. We may need to add a few people. I've really cut back the headcount here. And sooner or later, we're going to have to step up a bit.

嗯，這是吉姆，安東尼。我確實預計，隨著澳洲和印度臨床試驗的不斷進展，一般及行政費用將會增加。我們將盡力控制專業費用和薪資。我們可能需要增加幾個人。我確實削減了這裡的員工人數。或早或晚，我們都必須加緊努力。

Okay. So it sounds like you brought it down to sort of a bare bones level that you could. But as this trial moves on, obviously, there's some increased cost with that and then you may have to add a few people.

好的。因此，聽起來你已經將它降低到你能達到的最低限度的水平。但隨著試驗的進行，顯然成本會增加，可能需要增加幾個人。

Yes. I think that's fair, that's fair.

是的。我認為這是公平的，這是公平的。

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

我們的問答環節到此結束。我想將會議交還給吉姆·弗雷克斯先生，請他作最後發言。先生，請繼續。

Thank you again for joining us today to discuss our fiscal third quarter results. and 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第三季財報業績。我們期待在未來的電話會議中向您通報最新情況。再見。

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。

Portions of this transcript marked (technical difficulty) indicate audio problems. The missing text will be supplied if a replay becomes available.

本記錄中標記為（技術難題）的部分錶示有音訊問題。如果有重播，將會提供缺少的文字。