INmune Bio Inc (INMB) 2024 Q1 法說會逐字稿

Greetings, and welcome to the INmune Bio first-quarter 2024 earnings call.

您好，歡迎您參加 INmune Bio 2024 年第一季財報電話會議。

(Operator Instructions) At this time, it's my pleasure to introduce Mr. David Moss, CFO of INmune Bio.

（操作說明）此時，我很高興向您介紹INmune Bio 的財務長David Moss 先生。

David?

大衛？

Thank you, James, and good afternoon, everybody.

謝謝詹姆斯，大家下午好。

We thank you for joining us for the call for INmune Bio's first-quarter 2024 financial results.

我們感謝您參加我們的 INmune Bio 2024 年第一季財務業績電話會議。

With me on the call is Dr. R.J Tesi, CEO and Co-Founder of INmune Bio and Dr. Mark Lowdell, Chief Scientific Officer and Co-Founder of INmune Bio, who will provide an update on INKmune, our memory like Natural Killer Cell oncology platform.

與我一起參加電話會議的是INmune Bio 首席執行官兼聯合創始人R.J Tesi 博士和INmune Bio 首席科學官兼聯合創始人Mark Lowdell 博士，他們將提供INKmune 的最新信息，INKmune 是我們的記憶，就像自然殺手細胞一樣腫瘤學平台。

Before we begin, I remind everyone that except for statements of historical facts, the statements made by management and responses to questions on this conference call are forward-looking statements under the Safe Harbor provisions of the Private Securities Litigation Reform Act of 1995.

在開始之前，我提醒大家，除了歷史事實的陳述外，管理層在本次電話會議上所做的陳述和對問題的回答均屬於1995年《私人證券訴訟改革法案》安全港條款下的前瞻性陳述。

These statements involve risks and uncertainties that can cause actual results to differ materially from those such as forward-looking statements.

這些陳述涉及風險和不確定性，可能導致實際結果與前瞻性陳述等結果有重大差異。

Please see the forward-looking statements disclaimer in the company's earnings release, as well as risk factors in the company's SEC filings, including our most recent quarterly filings with the SEC.

請參閱公司收益發布中的前瞻性聲明免責聲明，以及公司向 SEC 提交的文件中的風險因素，包括我們最近向 SEC 提交的季度文件。

There's no assurance of any specific outcome.

無法保證任何具體成果。

Undue reliance should not be placed on forward-looking statements, which may which speak only as of the date they are made as the facts and circumstances underlying these forward-looking statements may change.

不應過度依賴前瞻性聲明，這些聲明僅代表發布之日的情況，因為這些前瞻性聲明所依據的事實和情況可能會發生變化。

Except as required by law, INmune Bio disclaims any obligations to update these forward-looking statements to reflect future information, events, or circumstances.

除法律要求外，INmune Bio 不承擔任何更新這些前瞻性聲明以反映未來資訊、事件或情況的義務。

With that behind us, now I'd like to turn the call over to Dr. R.J Tesi, CEO of INmune Bio.

有了這些之後，現在我想將電話轉給 INmune Bio 執行長 R.J Tesi 博士。

R.J?

R.J？

Thank you, David, and I thank everyone, for joining the call.

謝謝大衛，我也感謝大家加入這次電話會議。

As usual, I will arrange my remarks to highlight the key takeaways from the first quarter and the subsequent period and provide updates on our platform programs.

像往常一樣，我將安排我的發言，重點介紹第一季度和後續時期的主要要點，並提供有關我們平台計劃的最新資訊。

I will start by reviewing developments in the XPro platform and then pass it over to Mark Lowdell, who will update the INKmune program.

我將首先回顧 XPro 平台的開發情況，然後將其交給 Mark Lowdell，他將更新 INKmune 程式。

David, will conclude with a discussion of our financial results, including some commentary around the recent equity capital infusions and provide an update on upcoming milestones.

大衛將最後討論我們的財務業績，包括對最近股權資本注入的一些評論，並提供即將到來的里程碑的最新情況。

At a high level, steady progress on all fronts has continued over the last six weeks since we held our fourth quarter conference call in March.

從高水準來看，自三月召開第四季電話會議以來，過去六週以來，各方面持續取得穩定進展。

We continue to enroll patients globally in our early Phase 2 trial in Alzheimer's disease called AD02, and we expect to meet our target enrollment by mid-2024.

我們繼續在全球範圍內招募患者參加名為 AD02 的阿茲海默症早期 2 期試驗，我們預計在 2024 年中期實現我們的招募目標。

Clinical trial sites continue to enroll patients at a good clip, and we reiterate our commitment to complete enrollment mid-year.

臨床試驗中心繼續以良好的速度招募患者，我們重申我們對年中完成招募的承諾。

I know you want to know the exact date of our last patient enrollment, but we will not predict this because of the vagaries of predicting exact enrollment rates and pace.

我知道您想知道我們最後一次患者入組的確切日期，但我們不會預測這一點，因為預測確切的入組率和速度存在變數。

I promise you that as soon as we enroll that last patient, we will let everyone know.

我向您保證，一旦我們登記了最後一位患者，我們就會讓所有人知道。

Like you, we eagerly await the conclusion of the Phase 2 and the corresponding data readout that will occur about six weeks or just six months or so after that last patient is enrolled.

和您一樣，我們熱切地等待第二階段的結論以及相應的數據讀出，這將在最後一名患者入組後大約六週或六個月左右進行。

Recently, we provided an update on the long-term use of XPro in patients with Alzheimer's disease.

最近，我們提供了有關阿茲海默症患者長期使用 XPro 的最新資訊。

In that press release a week ago, we described two patients who participated in the Australian Phase 1 trial, one with MCI and the other was mild -- actually moderate Alzheimer's disease.

在一週前的新聞稿中，我們描述了兩名參加澳洲 1 期試驗的患者，其中一名患者患有 MCI，另一名患有輕度——實際上是中度阿茲海默症。

Both have been taking XPro roughly three years.

兩人都服用 XPro 大約三年了。

Due to the rules of clinical development in Australia, we cannot communicate directly with the patients, but the anecdotes that we see from their treating physicians highlighted the positive impact of XPro on the patient's cognitive health and the overall quality of life.

由於澳洲臨床開發的規則，我們無法直接與患者溝通，但我們從治療醫生那裡看到的軼事強調了 XPro 對患者認知健康和整體生活品質的積極影響。

If you haven't viewed the video links associated with that press release, I strongly encourage you to do so as they exemplify what we are trying to achieve with XPro in patients suffering with early AD. Obviously, this is a small sample, but the results speak for themselves.

如果您還沒有觀看與該新聞稿相關的視頻鏈接，我強烈建議您觀看，因為它們舉例說明了我們試圖透過 XPro 在患有早期 AD 的患者身上實現的目標。顯然，這是一個小樣本，但結果不言而喻。

Long term treatment with XPro in patients with Alzheimer's disease has been shown to be safe, well-tolerated and made a difference in the lives of these patients and their caregivers.

阿茲海默症患者長期使用 XPro 治療已被證明是安全的、耐受性良好的，並且對這些患者及其照護者的生活產生了影響。

The ongoing blinded, randomized placebo-controlled trials are a necessary step in the development process, and we believe we are helping these patients, their families, and their caregivers we live with this dreadful disease every day.

正在進行的盲法、隨機安慰劑對照試驗是開發過程中的必要步驟，我們相信我們正在幫助這些每天都與這種可怕的疾病生活在一起的患者、他們的家人和他們的照護人員。

Want to help you better understand three important elements of our ongoing Phase 2 trial.

希望幫助您更了解我們正在進行的第二階段試驗的三個重要要素。

The elements are duration, size, and primary endpoint.

這些元素是持續時間、大小和主要終點。

I'll start with the endpoints, primary endpoints.

我將從端點、主要端點開始。

The clinical trial is powered on the cognitive scale called CDR.

此臨床試驗是基於稱為 CDR 的認知量表。

CDR is a validated endpoint that has been used in the recent Phase 3 anti-amyloid trials that will all results and approval of those drugs.

CDR 是一個經過驗證的終點，已在最近的 3 期抗澱粉樣蛋白試驗中使用，該試驗將獲得這些藥物的所有結果和批准。

The endpoint is acceptable to regulatory authorities, certainly in the US and I respect globally in our Phase 1 trial, eight of the nine evaluable patients had stable or better cognition at three months.

該終點是監管機構可以接受的，當然在美國，在我們的一期試驗中，我尊重全球範圍內的情況，九名可評估患者中的八名在三個月內具有穩定或更好的認知能力。

Three of those patients had improved cognition to those were highlighted in the press release.

其中三名患者的認知能力比新聞稿中強調的有所改善。

We and this is where we differ a little bit on what the other companies do.

我們與其他公司的做法略有不同。

We believe some of the patients AD02 on XProgrowth will respond like those in the Phase 1 trial.

我們相信 XProgrowth 上的一些 AD02 患者會像第 1 期試驗中的患者一樣做出反應。

We need to be able to measure clinical improvements to do that.

為此，我們需要能夠衡量臨床改善情況。

We need a better more sensitive cognitive scales than CDR.

我們需要一個比 CDR 更好、更敏感的認知量表。

That is why we're using EMACC.

這就是我們使用 EMACC 的原因。

EMACC will allow us to accurately determine if patients have improved cognitive function and we believe that will be an important finding of the Phase 2 trial.

EMACC 將使我們能夠準確地確定患者的認知功能是否有所改善，我們相信這將是 2 期試驗的一個重要發現。

To be clear, the primary endpoint that will be used in the Phase 3 pivotal trial will come after discussion and after agreement with the regulatory agencies that we work with, including the FDA, EMA, MHRA, it may be CDR or maybe EMACC, that decision will be driven by data and the regulatory authorities, not by INmune Bio.

需要明確的是，3 期關鍵試驗中使用的主要終點將在與我們合作的監管機構（包括 FDA、EMA、MHRA）討論並達成協議後確定，可能是 CDR，也可能是 EMACC，決策將由數據和監管機構驅動，而不是由INmune Bio 驅動。

The size and duration of AD02 to the Alzheimer's trial are both smaller and shorter, respectively, compared to the other trials in Alzheimer's disease.

與其他阿茲海默症試驗相比，AD02 阿茲海默症試驗的規模較小，持續時間較短。

This trial design was based on careful analysis of our preclinical data, clinical data, and publicly available data.

該試驗設計是基於對我們的臨床前數據、臨床數據和公開數據的仔細分析。

First, I want to make a personal statement as a clinician.

首先，我想作為一名臨床醫生做一份個人陳述。

This is me talking this is not the company.

這是我說的，不是公司。

But when you put a patient into a clinical trial, then they get randomized to placebo.

但是當你讓患者參加臨床試驗時，他們會被隨機分配到安慰劑組。

We are asking that patient to allow their disease to progress under our care.

我們要求該患者讓他們的疾病在我們的護理下繼續發展。

In my opinion, we need to do everything possible to limit the number of patients who received placebo and how long they're on the placebo because we're really not benefiting the patients.

在我看來，我們需要盡一切可能限制接受安慰劑的患者數量以及他們服用安慰劑的時間，因為我們確實沒有讓患者受益。

The AD02 trial exposes patients to six months of placebo.

AD02 試驗讓患者服用六個月的安慰劑。

This is just one-third of the time in the anti-amyloid vials, they were 18 months long.

這只是抗澱粉樣蛋白小瓶中的三分之一，它們的有效期為 18 個月。

Shorter trials are good for patients, but is it bad for drug development and Alzheimer's disease.

較短的試驗對患者有利，但對藥物開發和阿茲海默症不利。

And the answer is clear, it is not that for.

而答案很明確，不是那為了。

Drug development in Alzheimer's disease.

阿茲海默症的藥物開發。

AD02 is fully powered to demonstrate a benefit at six months with XPro.

AD02 完全可以在 XPro 的六個月內展示其優勢。

And in fact, you realize that both of lecanemab and the donanemab trials, we're statistically positive at six months.

事實上，您意識到 Lecanemab 和 donanemab 試驗在六個月時的統計結果呈陽性。

They could have stopped those trials at six months and had the same result that we have today, that is the drug therapy is better than placebo.

他們本可以在六個月時停止這些試驗，並得到與我們今天相同的結果，即藥物治療比安慰劑更好。

There's nothing magical about an 18-month trial or 12-month trial.

18 個月或 12 個月的試用期並沒有什麼神奇之處。

The issue is statistical power and this is where our unique trial design matter.

問題在於統計功效，這就是我們獨特的試驗設計的重要性。

To our knowledge, AD02 is the only Alzheimer's trial that uses enrichment criteria to enroll patients.

據我們所知，AD02 是唯一使用豐富標準來招募患者的阿茲海默症試驗。

AD02 enrolled early Alzheimer's patients with biomarkers of inflammation.

AD02 招募了具有發炎生物標記的早期阿茲海默症患者。

There is a biologic and statistical advantage to this simple enrollment strategy.

這種簡單的入組策略具有生物學和統計學上的優勢。

The biological advantages that the mechanism of action of XPro targeting neuroinflammation is matched with the patient's disease that is the pathology that's driving their cognitive decline.

XPro 針對神經發炎的作用機制與患者的疾病相匹配，即導致認知能力下降的病理學，這是其生物學優勢。

Trials that don't use enrichment gamble that a large number of patients treated for a long time.

不使用濃縮療法的試驗是對大量患者進行長期治療的賭博。

We'll overcome statistical noise.

我們將克服統計噪音。

That's a risky and expensive strategy.

這是一個危險且昂貴的策略。

Benefits of enrichment are best seen in oncology drug development.

濃縮的好處在腫瘤藥物開發中得到了最好的體現。

Oncology clinical trials are routinely used enrichments to derisk clinical trials.

腫瘤學臨床試驗是常規使用的豐富手段來降低臨床試驗的風險。

This is called precision medicine.

這就是所謂的精準醫學。

Perceptive precision medicine is the standard in clinical oncology drug development, it should be the standard in CNS drug development, too.

感知精準醫學是臨床腫瘤藥物研發的標準，也應該成為中樞神經系統藥物研發的標準。

We are using a precision medicine approach.

我們正在使用精準醫學方法。

The second advantage is statistical on it.

第二個優點是統計上的。

So it's more subtle than this enrichment strategy.

所以它比這種豐富策略更微妙。

Patients with neuroinflammation with Alzheimer's disease progressed more quickly and more reliably than patients without neuroinflammation.

患有阿茲海默症的神經發炎患者比沒有神經發炎的患者進展更快、更可靠。

This is kind of a terrible thing to say, but it's a biological reality.

說起來有點可怕，但這是一個生物學現實。

Put in the language of a statistician who are critical and defined in the trial.

用在試驗中持批判態度和定義的統計學家的語言來表達。

The increased delta of difference between placebo and active arm and the lower variants provide important statistical advantages.

安慰劑組和活性組之間差異的增加以及較低的變異體提供了重要的統計優勢。

Overall, the trial was well designed, derisks, and relevant to today's patients with Alzheimer's.

總體而言，該試驗設計良好，風險較小，並且與當今的阿茲海默症患者相關。

To be smart with drug and drug supply and capital resources, we have closed enrollment of the Phase 2 open label extension.

為了明智地利用藥品、藥品供應和資本資源，我們已經結束了第二階段開放標籤擴展的註冊。

Remember, the open-label extension was patients were going to be offered 12 months of therapy in an open label trial as sort of a reward for being in the randomized blinded trial and also to give us additional safety and efficacy data.

請記住，開放標籤延期是指患者將在開放標籤試驗中接受 12 個月的治療，作為參與隨機盲法試驗的獎勵，同時也為我們提供了額外的安全性和有效性數據。

This was a practical consideration by the company.

這是公司的實際考量。

Having a large patient population on drug for 12 months consumes both drug and treasure.

大量患者連續 12 個月服用藥物，既消耗藥物，也消耗財富。

First question many ask is what will the FDA say?

許多人問的第一個問題是 FDA 會說什麼？

I remind you the Phase 2 trial is not a registration file.

我提醒您，第二階段試用不是註冊文件。

The purpose of the Phase 2 is to demonstrate safety and efficacy of XPro in the target population.

第二階段的目的是證明 XPro 在目標族群中的安全性和有效性。

Patients with early AD and biomarkers of neuroinflammation.

患有早期 AD 和神經發炎生物標記的患者。

At the end of the Phase 2 trial will have a end of Phase 2 meetings with the regulatory authorities where we will negotiate the design of the Phase 3 clinical trial.

在第二階段試驗結束時，我們將與監管機構舉行第二階段會議，我們將在會議中協商第三階段臨床試驗的設計。

The FDA worries about both safety and efficacy.

FDA 擔心安全性和有效性。

There's no question that FDA want more patients treated with XPro who have Alzheimer's disease.

毫無疑問，FDA 希望更多阿茲海默症的患者接受 XPro 治療。

The question is, will they want patients treated long for a longer period of time?

問題是，他們會希望患者接受更長時間的治療嗎？

In my mind, the FDA is very focused on doing no harm, that is a part of their chart and to ask the patient to be on placebo for 12 or 18 months when we are in one day.

在我看來，FDA 非常注重不造成傷害，這是他們圖表的一部分，並要求患者在我們所處的某一天服用安慰劑 12 或 18 個月。

And we already have data to show that you get an effective clinical readout at six months may prove to be an ethical dilemma.

我們已經有數據表明，在六個月內獲得有效的臨床讀數可能會被證明是一個道德兩難。

At this time, we can now predict what the FDA along with the Phase 3 trial, I predict and once again, this is R.J Tesi talking not INmune Bio that the FDA will want a larger trial, but not necessarily a longer trial.

現在，我們現在可以預測 FDA 以及 3 期試驗，我預測，這是 R.J Tesi 說的，而不是 INmune Bio，FDA 將想要進行更大規模的試驗，但不一定是更長的試驗。

The FDA does provide mechanisms to speed drugs through the drug development process.

FDA 確實提供了加快藥物開發過程的機制。

The accelerated approval pathways are in place for this purpose.

為此目的，已製定了加速審批途徑。

We believe XPro for Alzheimer's disease will qualify for accelerated approval.

我們相信治療阿茲海默症的 XPro 將有資格獲得加速批准。

Our pathway, we will apply for a fast-track approval.

我們的途徑是，我們將申請快速審批。

Based on our preclinical in Phase 1 data, we may be eligible for breakthrough status after we complete the Phase 2 clinical trial.

根據我們一期臨床前的數據，在完成二期臨床試驗後，我們可能有資格獲得突破性進展。

We cannot predict how the FDA, which respond to our applications, but we believe XPro's unique mechanism of action importance of neuroinflammation and glial activation in the path of physiology of Alzheimer's disease, combined with our clinical data will be a compelling story.

我們無法預測FDA 如何回應我們的申請，但我們相信XPro 獨特的作用機制對神經發炎和神經膠質活化在阿茲海默症生理學路徑中的重要性，結合我們的臨床數據將是一個引人注目的故事。

Finally, you've heard us talk about the many CNS diseases that XPro can be applied to all that have neuroinflammation as part of the underlying pathophysiology.

最後，您已經聽到我們談論 XPro 可應用於所有以神經發炎為基礎病理生理學的疾病。

We have 87 publications on our website with 12 different disease.

我們的網站上有 87 篇出版物，涉及 12 種不同的疾病。

This is the future of XPro.

這就是 XPro 的未來。

It is a CNS franchise and a drug.

它是中樞神經系統專營權和藥物。

For now treatment resistant depression will be the first disease beyond Alzheimer's disease that we develop.

目前，治療抵抗性憂鬱症將是我們開發的阿茲海默症以外的第一種疾病。

We will have further announcements on the treatment resistant depression Phase 2 program using XPro in the near future.

我們將在不久的將來發布有關使用 XPro 治療難治性憂鬱症第 2 期計畫的進一步公告。

Our goal is to arrive enroll that first patient in NIH boarded Phase 2 trial in the second half of this year.

我們的目標是在今年下半年讓 NIH 的第一位患者參加第 2 期試驗。

I will now pass the mic to Mark Lowdell, Co-Founder and CSO of INmune Bio to update progress on the INKmune program.

我現在將把麥克風交給 INmune Bio 聯合創始人兼 CSO Mark Lowdell，以更新 INKmune 專案的進度。

Mark?

標記？

Thanks, R.J, and thanks, everyone, for dialing in.

謝謝 R.J，也謝謝大家撥電話。

And yes, I'm going to tell you where we've got to with our prostate cancer trial called CaRePC and is unique in many ways as this be typical for a company.

是的，我要告訴你我們的前列腺癌試驗 CaRePC 的進展情況，它在很多方面都是獨一無二的，因為這對於一家公司來說是典型的。

First, the concept.

首先，概念。

This is an NK targeting therapy that doesn't actually administer NK cells or use cytokine which are typical historical uses of NK targeting therapies.

這是一種 NK 標靶療法，實際上並未施用 NK 細胞或使用細胞因子，而細胞激素是 NK 標靶療法的典型歷史用途。

INKmune converts the patient's own NK cells in circulation and probably actually within the tumor from resting non-cancer killing state to what we now know are memory-like NK cells that are able to destroy NK resistant cancer cells.

INKmune 將患者自身循環中的 NK 細胞（實際上可能是腫瘤內的 NK 細胞）從靜止的非癌症殺傷狀態轉化為我們現在所知的記憶樣 NK 細胞，能夠破壞 NK 抗性癌細胞。

Unlike more conventional adoptive immunotherapies with NK cells from donors, patients don't require any type of preconditioning chemotherapy, nor do they require NK stimulating cytokine that is common to other NK activating therapies.

與使用來自捐贈者的 NK 細胞的更傳統的過繼免疫療法不同，患者不需要任何類型的預處理化療，也不需要其他 NK 活化療法常見的 NK 刺激細胞因子。

The INmune patients sitting in a chair as an outpatient getting intravenous infusions over about 20 minutes and then having received that dose of INKmune, they're able to leave.

INmune 患者作為門診病人坐在椅子上接受靜脈輸液約 20 分鐘，然後接受該劑量的 INKmune，他們就可以離開。

We've given over 20 doses of INKmune in outpatient setting so far.

到目前為止，我們已經在門診提供了 20 多劑 INKmune。

Each infusion has been remarkably boring for the patient and as importantly, boring for the clinical team because it's been so well tolerated.

每次輸注對患者來說都非常無聊，同樣重要的是，對於臨床團隊來說也很無聊，因為它的耐受性非常好。

Each patient in the trial is monitored for immunological endpoints, as you would expect.

正如您所期望的，試驗中的每位患者都會接受免疫學終點監測。

And these include NK cell number phenotype of those NK cells, their ability to kill and NK resistant tumor cells.

這些包括 NK 細胞的數量、這些 NK 細胞的表型、它們殺死和 NK 抗藥性腫瘤細胞的能力。

We also measure tumor related variables.

我們也測量腫瘤相關變數。

In this metastatic castrate resistant prostate cancer trial, we measure anti-tumor effects by following blood, prostate-specific antigen levels, tumor volume with PMSA scans, and we measure circulating tumor DNA.

在這項轉移性去勢抵抗性前列腺癌試驗中，我們透過追蹤血液、前列腺特異性抗原水平、PMSA 掃描腫瘤體積來測量抗腫瘤效果，並測量循環腫瘤 DNA。

So this rich dataset will allow us to determine whether the drug is ready for a pivotal trial at the end of Phase 2.

因此，這個豐富的數據集將使我們能夠確定該藥物是否已準備好在第二階段結束時進行關鍵試驗。

Phase 1, Phase 2 trials expected to enroll 30 patients.

1期、2期試驗預計招募30名患者。

And the men enrolled in CaRePC have all received previous high-dose therapy, but now have metastatic castrate resistant disease.

參加 CaRePC 的男性之前都接受過高劑量治療，但現在患有轉移性去勢抵抗性疾病。

In the trial, they received three infusions of INKmune, as I said, on outpatient basis, it with a six month follow-up.

在試驗中，正如我所說，他們在門診接受了 3 次 INKmune 輸注，並進行了六個月的追蹤。

We have three centers enrolling patients at the moment, a fourth opening this month and four more planned to open over the next few months.

目前我們有三個中心正在招募患者，第四個中心將於本月開業，另外四個中心則計劃在未來幾個月內開業。

The Phase 1 portion of the trial will be completed by September this year, and we expect patient enrollment in the Phase 2 portion to be completed by the second quarter of next year with data available for all of the patients by the end of 2025 at the latest.

該試驗的第一階段部分將於今年 9 月完成，我們預計第二階段部分的患者入組將於明年第二季度完成，並在 2025 年底前獲得所有患者的數據。

It is an open-label trial, which means that we're looking forward to some snapshots of the data in 2024 or early 2025.

這是一項開放標籤試驗，這意味著我們期待在 2024 年或 2025 年初獲得一些資料快照。

Equally important is the trial.

同樣重要的是審判。

The INKmune team has been working very hard on perfecting the manufacturing and logistics elements of INKmune for future clinical and commercial development.

INKmune 團隊一直在努力完善 INKmune 的製造和物流要素，以適應未來的臨床和商業開發。

So I still have a part-time university post.

所以我還有一個兼職的大學職位。

I'm wearing my academic has over the last 35 years.

我穿著過去 35 年的學術服裝。

I've seen an awful lot of promising therapeutic strategies in the cell and gene therapy space fail due to manufacturing and logistical problems.

我看到細胞和基因治療領域中有很多有前途的治療策略由於製造和物流問題而失敗。

And I'm sure you'll all be aware of some of those associated with adoptive immunotherapies like CAR-T cells.

我相信你們都會知道其中一些與 CAR-T 細胞等過繼免疫療法相關的內容。

We're scaling up the manufacturing process for INKmune in preparation for the pivotal trial, and we perfected the quality and release assays, which will be required by the regulatory authorities as we move forward.

我們正在擴大 INKmune 的製造工藝，為關鍵試驗做準備，並且我們完善了品質和釋放檢測，這將是監管機構在我們前進過程中所要求的。

Because the product shipps on dry ice logistics and storage and treatment centers are easy and they sit with many other commercial drugs.

因為該產品透過乾冰運輸，物流、儲存和治療中心很容易，它們與許多其他商業藥物坐在一起。

So in summary, we can make the drug.

綜上所述，我們可以製造這種藥物。

We can quality control release the drug, we can ship it and hospitals can store the drug.

我們可以對藥物進行品質控制，我們可以運輸它，醫院可以儲存藥物。

The clinical trials will determine the drug's therapeutic value as we move forward.

隨著我們的進展，臨床試驗將確定該藥物的治療價值。

Our pivot from hematological malignancies to solid tumors was not a one tumor project and has been well planned initial transition transition into the solid tumor space.

我們從血液惡性腫瘤轉向實體瘤並不是一個單一的腫瘤項目，並且已經精心計劃了向實體瘤領域的初步過渡。

The unique attributes of INKmune primed NK cells and make them ideal to treat a wide variety of solid tumors and we've published papers on some of those.

INKmune 引發的 NK 細胞的獨特屬性使其成為治療多種實體瘤的理想選擇，我們已經發表了有關其中一些的論文。

Prostate cancer is a test case, but we found preclinical work in ovarian cancer, and we're developing the same data in renal cell carcinoma at the momen/t as we obtain resources, these will be the next targets for INKmune therapy.

前列腺癌是一個測試案例，但我們在卵巢癌中發現了臨床前工作，當我們獲得資源時，我們正在開發腎細胞癌中相同的數據，這些將是 INKmune 治療的下一個目標。

So that ends my update on the INKmune platform, and I'd like to turn the call over to David Moss, our CFO and the Co-Founder to discuss the financials.

我對 INKmune 平台的更新到此結束，我想將電話轉給我們的財務長兼聯合創始人 David Moss，討論財務狀況。

Thank you, David.

謝謝你，大衛。

Thank you, Mark.

謝謝你，馬克。

As usual, I'll provide a brief overview of our financial results and upcoming milestones to before we head to our Q&A session.

像往常一樣，在我們開始問答環節之前，我將簡要概述我們的財務表現和即將到來的里程碑。

However, I'd like to begin with some comments on our recent capital equity raises as we get closer to our Phase 2 Alzheimer's readout and INKmune data.

然而，隨著我們接近 2 期阿茲海默症讀數和 INKmune 數據，我想先對我們最近的資本股權融資發表一些評論。

We are pleased to have raised $14.5 million in gross proceeds from two separate equity offerings over the past weeks at an average price of $8.35 in $9.84 per share.

我們很高興在過去幾週透過兩次單獨的股票發行籌集了 1,450 萬美元的總收益，平均價格為 8.35 美元，每股 9.84 美元。

In the two transactions, the company issued an aggregate of approximately 1.5 million shares of common stock and warrants to purchase an aggregate of approximately 1.5 million shares of common stock.

在兩筆交易中，公司發行了總計約150萬股普通股以及購買總計約150萬股普通股的認股權證。

The exercise price of the warrants is $9.15 and $9.84, respectively.

認股權證的行使價分別為9.15美元和9.84美元。

The warrants are exercisable on the earlier of two year anniversary of the initial exercise date or 30 days following the reporting of top line data in the Phase 2 Alzheimer's program for XPro.

認股權證可在初始行使日期兩週年或 XPro 第二階段阿茲海默症計畫報告頂線資料後 30 天（以較早者為準）行使。

In the first $4.8 million raise management, employees and members of the Board of Directors purchased over $1 million worth of stock.

在第一批 480 萬美元的融資中，員工和董事會成員購買了價值超過 100 萬美元的股票。

I cannot underscore how financially committed and aligned the entire INmune team is the success of the company.

我無法強調整個 INmune 團隊在財務上的投入和協調是公司成功的關鍵。

We greatly appreciate the support from our existing shareholders and the support we saw in both offerings for mostly existing investors.

我們非常感謝現有股東的支持以及我們在這兩項發行中看到的對大多數現有投資者的支持。

Our team here at INmune , but also we welcome a few new holders to the registry.

我們在 INmune 的團隊，同時也歡迎一些新的持有者加入註冊表。

Now moving on to the financials.

現在轉向財務方面。

Net loss attributable to common stockholders for the quarter ended March 31, 2024 was approximately $11 million compared with approximately $6.5 million for the comparable period as we've reached scale with both of our clinical programs.

截至 2024 年 3 月 31 日的季度，普通股股東應佔的淨虧損約為 1,100 萬美元，而同期的淨虧損約為 650 萬美元，因為我們的兩個臨床項目都已達到規模。

Research and development expenses totaled approximately $8.7 million for the quarter ended March 31, 2024, compared with approximately $4.1 million for the comparable period.

截至 2024 年 3 月 31 日的季度，研發費用總計約為 870 萬美元，而同期的研發費用約為 410 萬美元。

General and administrative expenses was approximately $2.3 million for the quarter ended March 31, '24, compared with approximately $2.3 million for the comparable period in '23.

截至 2024 年 3 月 31 日的季度，一般及管理費用約為 230 萬美元，而 2023 年同期約為 230 萬美元。

At March 31, 2024, the company had cash and cash equivalents of approximately $26 million.

截至2024年3月31日，該公司擁有現金及現金等價物約2,600萬美元。

This figure does not include the recent raises.

這個數字不包括最近的加薪。

Based on our current operating plan, we believe our cash is sufficient to fund our operations into 2025.

根據我們目前的營運計劃，我們相信我們的現金足以支持我們到 2025 年的營運。

As of May 9, 2024, the company had approximately 19.8 million shares of common stock outstanding.

截至2024年5月9日，該公司已發行普通股約1,980萬股。

Now I'd like to focus on some key upcoming milestones.

現在我想專注於即將到來的一些關鍵里程碑。

Full enrollment in the Phase 2 extra trial for the treatment of neuroinflammation as a cause of Alzheimer's disease are expected mid-2024, followed by top-line data, approximately six months from the last patient enrolled.

治療阿茲海默症引起的神經發炎的 2 期額外試驗預計將於 2024 年中期完成全部入組，隨後將在距離最後一名患者入組約六個月後公佈頂線數據。

We will initiate a Phase 2 trial of XPro in patients with treatment resistant depression in the second half of this year.

我們將於今年下半年針對難治性憂鬱症患者啟動 XPro 的 2 期試驗。

Last week, we announced completion of Cohort 1 for the first of our three patients, taking part in the metastatic castration resistant prostate program.

上週，我們宣布完成三名患者中第一名患者的第一組治療，參加轉移性去勢抵抗性前列腺計畫。

We expect Cohort 2 to start shortly.

我們預計第二組很快就會開始。

We expect complete enrollment in the Phase 1 portion of the metastatic castration resistant prostate trial by the end of Q3 '24, and the Phase 2 portion is expected to complete enrollment in Q2 of '25.

我們預計轉移性去勢抵抗性前列腺試驗的第一階段部分將在 24 年第三季末完成入組，第二階段部分預計將在 25 年第二季完成入組。

Although we've secured additional funding.

儘管我們已經獲得了額外的資金。

As always, we continue to focus on achieving our primary clinical objectives while remaining cost prudent with the potential to recover a portion of R&D expenses in Australia and the UK.

一如既往，我們繼續專注於實現我們的主要臨床目標，同時保持成本審慎，有可能收回澳洲和英國的部分研發費用。

Further, the recent changes R.J mentioned with regards to the open-label extension will save the company a $2 million in drug and trial related expenses.

此外，R.J 最近提到的有關開放標籤擴展的變化將為公司節省 200 萬美元的藥物和試驗相關費用。

In summary, we secured a meaningful equity infusion recently that puts us in good position heading into data and our focus remains solely on execution.

總之，我們最近獲得了有意義的股權注入，這使我們在數據方面處於有利地位，而我們的重點仍然是執行。

At this point, I'd like to thank you for your time and attention.

在此，我要感謝您的時間和關注。

I'd like to turn it back to James to poll for questions.

我想把它轉回詹姆斯來詢問問題。

James?

詹姆士？

(Operator Instructions)

（操作員說明）

Tom Shrader, BTIG.

湯姆‧施雷德 (Tom Shrader)，BTIG。

Good afternoon.

午安.

Thanks for taking the question.

感謝您提出問題。

So R.J, you must be thinking about the role of beta antibodies in your Phase 3.

所以 R.J，您一定正在考慮 β 抗體在第三階段中的作用。

Is there any guidance or thoughts are you going to be able to stratify or could you still do a monotherapy trial?

有什麼指導或想法可以讓您分層，或者您仍然可以進行單一療法試驗嗎？

I'm just curious if there's any sort of thought yet.

我只是好奇是否還有任何想法。

And then a quick one for Mark.

然後是馬克的快速發言。

I understand Mark boring is good, but would do you would you expect some fever if you're turning on NK cells, just the your historical thoughts on why things are so safe?

我知道馬克無聊是好的，但是如果你打開 NK 細胞，你會不會期待一些發燒，只是你對為什麼事情如此安全的歷史想法？

Thanks.

謝謝。

So let me thank you, Tom, for those.

湯姆，讓我感謝你。

Very interesting question about the anti-amyloid.

關於抗澱粉樣蛋白的非常有趣的問題。

We have signaled very strongly.

我們已經發出了非常強烈的訊號。

We are aware that we're going to have to be able to answer the question about combination therapy used.

我們知道我們必須能夠回答有關聯合治療的問題。

I think we've said that you should expect some preclinical data to that regard from us mid-year.

我想我們已經說過，您應該期待我們在年中提供一些這方面的臨床前數據。

What's more important, though, is how will it affect the Phase 3 clinical trial.

但更重要的是它將如何影響第三期臨床試驗。

At least in the United States the only place these drugs are currently approved adoption has been slow.

至少在目前批准這些藥物的唯一地方美國，採用進展緩慢。

So I believe that there will be plenty of patients who are not on the anti-amyloid drugs who will be potential clinical trial participants in the United States and other regulatory jurisdictions like the Europe, UK, Canada and beyond.

因此，我相信，在美國和歐洲、英國、加拿大等其他監管管轄區，有大量未服用抗澱粉樣蛋白藥物的患者將成為潛在的臨床試驗參與者。

We don't know when those drugs are going to be approved, it will be approved by the time we start our Phase 3.

我們不知道這些藥物何時會獲得批准，但在我們開始第三階段時就會獲得批准。

No doubt.

毫無疑問。

Once again, those drugs have had slow adoption.

這些藥物再次被緩慢採用。

So I am we are not concerned at this point.

所以我認為我們目前並不擔心。

We believe a combination trial is actually a different development pathway that may be answering a different question then whether XPro works alone for patients in Alzheimer's with the neuroinflammation.

我們認為，聯合試驗實際上是一種不同的開發途徑，可能會回答一個不同的問題，即 XPro 是否單獨對患有神經發炎的阿茲海默症患者有效。

David, do you want me to comment on, is Mark on the phone?

大衛，你想讓我評論一下嗎，馬克在打電話嗎？

I think his call may have dropped.

我想他的電話可能已經斷線了。

Mark, you there?

馬克，你在嗎？

I'll tell you what, Mark got dropped.

我告訴你吧，馬克被拋棄了。

He's got to call it.

他必須打電話。

In relation to your question, Tom, why you don't see a fever or some sort of inflammatory response, why the drug out of the safe?

關於你的問題，湯姆，為什麼你沒有看到發燒或某種發炎反應，為什麼藥物從保險箱拿出來？

So the answer to the question was about term, no fever.

所以問題的答案是足月，不發燒。

Why no inflammatory reactions with INKmune?

為什麼 INKmune 沒有發炎反應？

Well INKmune activates NK cells and it doesn't activate T cells.

INKmune 活化 NK 細胞，但不活化 T 細胞。

Sowe've spent a lot of time looking at that.

Sowe花了很多時間研究這個問題。

So the inflammatory response, you see cytokine release syndrome is entirely T cell mediated.

所以發炎反應，你看細胞激素釋放症候群完全是 T 細胞介導的。

So, it's released inflammatory cytokines from CD4 T cells and NK cells, which are activated by INKmune or even by cytokines don't secrete inflammatory cytokine.

因此，它從 CD4 T 細胞和 NK 細胞中釋放發炎細胞因子，這些細胞被 INKmune 激活，甚至被不分泌發炎細胞因子的細胞因子激活。

So NK therapy itself and what it has been associated with inflammatory type reactions.

那麼 NK 療法本身以及它與發炎類型反應的關係。

Got it.

知道了。

Okay.

好的。

Thanks for thanks for the thoughts on both nanotechnology to understand.

感謝您對奈米技術的理解的想法。

It's a very smart question actually, because it's normally the cytokins that are administered to sustain NK cells that cause side effects and of course INKmune doesn't require the administration decided cytokine.

實際上這是一個非常聰明的問題，因為通常是為了維持 NK 細胞而施用的細胞激素會引起副作用，當然 INKmune 不需要施用決定的細胞激素。

So specifically NK cell targeting.

特別是 NK 細胞標靶。

Got it, okay.

明白了，好吧。

Thank you.

謝謝。

Joel Beatty, Baird.

喬爾·比蒂，貝爾德。

Hi, thanks for taking the questions.

您好，感謝您提出問題。

The first one is for the ongoing Phase 2 trial in early AD. Can you remind us of the mix of patients you're targeting an enrollment between the ones that have mild cognitive impairment versus mild AD and how enrollment is tracking with that?

第一個是針對西元早期正在進行的第二階段試驗。您能否提醒我們，您計劃招募的患者包括輕度認知障礙患者和輕度 AD 患者，以及招募情況是如何追蹤的？

Yes, good question.

是的，好問題。

So two things, two points to make.

所以有兩件事、兩點要說明。

It's relevant considering my comments on placebo.

考慮到我對安慰劑的評論，這是相關的。

We have a team of one entrollment of active to placebo.

我們有一支由一名活性藥物和安慰劑組成的團隊。

In other words for every group of three patients, two patients get that problem and one patient gets placebo.

換句話說，對於每組三名患者，兩名患者出現該問題，一名患者接受安慰劑。

So that's number one.

所以這是第一。

Number two, the way the protocol is written, there will not be more than a two-to-one balance.

第二，協議的編寫方式不會超過二比一的平衡。

In other words, there were always -- we don't specify whether it's twice as many early mild AD as MCI or twice as many MCI as mild AD.

換句話說，我們並沒有具體說明早期輕度 AD 的數量是 MCI 的兩倍，還是 MCI 的數量是輕度 AD 的兩倍。

It will not be a -- it will really be an early AD trial like all the other ones do.

這不會是一個——它真的會像所有其他試驗一樣是一個早期的 AD 試驗。

Statistically, I would expect you would expect more MCI patients.

從統計數據來看，我預計會有更多 MCI 患者。

But as you recall, we started the trial with only enrolling for mild AD patients.

但正如您所記得的，我們開始試驗時只招募了輕度 AD 患者。

So I suspect it will be very close to 50:50 mix.

所以我懷疑混合比例會非常接近 50:50。

Don't hold me to that.

別讓我這麼做。

That's a prediction, but it's the way it's looking right now, it's going to be about a 50:50.

這是一個預測，但從目前的情況來看，比例大約是 50:50。

Okay, great.

好的，太好了。

And then the question on the open-label extension study that some I guess, a quick clarification.

然後是關於開放標籤擴展研究的問題，我想對此進行快速澄清。

Has it just been enrollments that's close, but some patients in the study are continuing to be dosed or is dosing come complete in all patients?

是否只是入組結束，但研究中的一些患者仍在繼續接受給藥，還是所有患者的給藥都已完成？

And in any case, are there plans to share the open-label extension data that you have collected?

無論如何，是否有計劃分享您收集的開放標籤擴展數據？

Yes.

是的。

So that's a good question.

這是一個好問題。

The open label extension data that we have has always been complicated by the fact that we don't know what the patients were on at entry.

由於我們不知道患者在進入時服用什麼藥物，因此我們擁有的開放標籤擴展數據一直很複雜。

Remember they come into the trial after a blinded randomized trial, so we don't know.

請記住，他們是在盲法隨機試驗後進入試驗的，所以我們不知道。

So we haven't figured out the best way to analyze those.

所以我們還沒有找到分析這些的最佳方法。

Right now because of really, as I said, both drug supply and financial considerations abide really.

現在，正如我所說，藥品供應和財務方面的考慮確實存在。

Drug supply is a financial consideration because making this stuff is not a small task.

藥品供應是一個財務考慮因素，因為製造這種東西不是一項小任務。

We are we are basically now working with the sites to decide the best path.

我們現在基本上正在與網站合作來決定最佳路徑。

Some patients will go on to a kind of a scheme where they are.

有些患者會繼續進行某種計劃。

They get compassionate use that's available to them and some will not be will be discontinued.

他們會得到可用的同情使用，有些不會被停止。

It's not you know, the company is not happy with this turn of events, but it is a practical consideration.

不是你知道嗎，公司對這樣的發展並不滿意，但這是出於實際考量。

Our goal and our commitment to investors is to make sure we finish the Phase 2 trial, get the result we're looking for and that's where we're focusing our resource.

我們的目標和對投資者的承諾是確保完成第二階段試驗，獲得我們正在尋找的結果，這就是我們集中資源的地方。

Thank you.

謝謝。

Jason McCarthy, Maxim Group.

傑森麥卡錫，馬克西姆集團。

Thanks for taking the questions.

感謝您提出問題。

I guess, this is R.J thoughts, type of question.

我想，這是 R.J 的想法，問題類型。

R.J, can you kind of opine a little bit on what do you think regulators might want in terms of timing for this trial?

R.J，您能否就您認為監管機構可能希望本次試驗的時間安排發表一些看法？

You said that the two approved amyloid drugs at six months already saw that they are effective.

您說這兩種被批准的澱粉樣蛋白藥物在六個月時就已經看到它們是有效的。

But given what you know now about markers of inflammation, seemingly FDA willingness to accept a correlation between biomarkers and outcomes pub in Alzheimer's disease and with any current standard of care in mild or early Alzheimer's, what is the expected rate of decline?

但考慮到您現在對發炎標記物的了解，FDA 似乎願意接受阿茲海默症生物標記與結果之間的相關性，以及目前輕度或早期阿茲海默症的照護標準，預期下降率是多少？

Can you really get a trial that's just three to six months because of all the inflammatory biomarkers that are available that the FDA seems to be more accepting of?

由於 FDA 似乎更容易接受所有可用的發炎生物標記物，您真的可以進行僅三到六個月的試驗嗎？

So a good question, and I'm going to answer it in a series of statements.

這是一個很好的問題，我將透過一系列陳述來回答它。

First of all, I'm not predicting three months.

首先，我並不是預測三個月。

Our trial is six months, three months is pretty quick.

我們的試用期是六個月，三個月很快。

When would we expect robust results after six months.

六個月後我們什麼時候可以期待強勁的結果。

Now let's talk a little bit about the biomarkers.

現在讓我們來談談生物標誌物。

Our biomarkers of neuroinflammation in the Phase 2 trial, our enrichment criteria.

我們二期試驗中的神經發炎生物標記物，我們的富集標準。

In other words, there are things you need for enrollment.

換句話說，註冊時需要一些東西。

The FDA, I'm not convinced that the FDA will be, will accept biomarkers of neuroinflammation as a biomarker of Alzheimer's.

我不相信 FDA 會接受神經發炎生物標記作為阿茲海默症的生物標記。

What they will accept are biomarkers of what they consider Alzheimer's, which are amyloid, tau, GFAP which is a glial fibrillary acidic protein, a biomarkers astrocyte.

他們會接受的是他們所認為的阿茲海默症的生物標記，即澱粉樣蛋白、tau蛋白、GFAP（一種膠質纖維酸性蛋白）、星狀細胞的生物標記。

Now the good news is there's very good blood tests for all of those and I predict that we will actually show a decrease in those biomarkers and the Phase 2 trial in patients who get XPro.

現在好消息是對所有這些都進行了非常好的血液測試，我預測我們實際上會在接受 XPro 的患者中顯示這些生物標記和 2 期試驗的減少。

So my bet is that what we've got is we're going to be focused on patients who have neuroinflammation because that's how the drug works.

所以我敢打賭，我們將重點放在患有神經發炎的患者，因為這就是藥物的作用原理。

But we don't think that the FDA will make surprised mind but we don't think the FDA will actually focus on neuroinflammation as a response.

但我們認為 FDA 不會對此感到驚訝，但我們認為 FDA 不會真正將重點放在神經發炎上作為應對措施。

They're going to stick to the biomarkers they know and they know amyloid and tau, and they might be interested in GFAP's and I don't think they'll be interest in NfL neurofilament light chain in Alzcheimer's.

他們將堅持使用他們知道的生物標記物，他們知道澱粉樣蛋白和 tau 蛋白，他們可能對 GFAP 感興趣，但我認為他們不會對阿茲海默症中的 NfL 神經絲輕鏈感興趣。

So those are my prediction.

這些是我的預測。

But I think I really think if we do as well as we think we are, we've got a placebo group that's racing to really quite a significant cognitive impairment and the XPro Group, which is relatively stable.

但我認為，如果我們做得像我們想像的那樣好，我們就會有一個安慰劑組，它正在加速出現相當嚴重的認知障礙，而 XPro 組則相對穩定。

I don't think they're going to force us to treat patients on placebo for a very long time.

我認為他們不會強迫我們在很長一段時間內用安慰劑治療患者。

But there're going want to go to want to see more patients. 200 patients will not be the size of the next trial.

但人們會想去看看更多的病人。 200 名患者不會是下一次試驗的規模。

It will be at least double that probably three times that my prediction.

這將至少是我預測的兩倍，可能是我預測的三倍。

So from -- in the placebo group, even with acetylcholinesterase inhibitors or something like that, how far out can they go even with the true placebo effect and then start to decline kind of like not to fake it till you make it?

那麼，在安慰劑組中，即使使用乙醯膽鹼酯酶抑制劑或類似的藥物，即使具有真正的安慰劑效應，他們又能走多遠，然後開始下降，就像在成功之前不假裝一樣？

But you know what I mean where that they will eventually

但你知道我的意思 他們最終會

-- (multiple speakers)

——（多位發言者）

Yes, so two points, if you see the acetylcholinesterase inhibitors in general, after three months, certainly after six months, you don't see any benefits with those drugs.

是的，所以有兩點，如果您總體上看到乙醯膽鹼酯酶抑制劑，三個月後，當然是六個月後，您不會看到這些藥物有任何好處。

Patients have to be on a stable therapy before they can be enrolled, and that's for three months.

患者必須接受穩定的治療才能入組，為期三個月。

So any patient that would be entrolled with acetylcholinesterase, inhibitor in that result for instance, would have been on the drug long enough that they are no longer benefiting from the drug.

因此，任何接受乙醯膽鹼酯酶（例如該結果的抑制劑）的患者都將服用該藥物足夠長的時間，以至於他們不再從該藥物中受益。

But many patients are on the drug and it's really the doctors are treating themselves as much as they're treating the patients atleast, that's my clinical view.

但許多患者都在服用藥物，醫生實際上是在治療自己，至少在治療患者，這是我的臨床觀點。

I think that the early question asked by the Tom Shrader's Group was regarding anti-amyloid is interesting.

我認為湯姆·施雷德小組早期提出的關於抗澱粉樣蛋白的問題很有趣。

I don't think the the monotherapy trial will not -- patients won't be on maintenance anti-amyloid.

我不認為單一療法試驗不會－患者不會接受維持性抗澱粉樣蛋白治療。

That will be a separate file and a separate question that we will ask hopefully with a partner that has an anti-amyloid drug because they're the ones who I think will be the most curious if the addition of combination therapy may improve both the safety profile of those drugs and the efficacy profile.

這將是一個單獨的文件和一個單獨的問題，我們希望向擁有抗澱粉樣蛋白藥物的合作夥伴詢問，因為我認為他們是最好奇的人，如果添加聯合療法可以提高安全性這些藥物的概況和功效概況。

But that's the question of the future.

但這是未來的問題。

And the first thing we need to do as prove that the combination of safe and animal models.

而我們要做的第一件事就是證明安全性和動物模型的結合。

And as I mentioned, those studies are underway.

正如我所提到的，這些研究正在進行中。

And just one quick question on INKmune.

關於 INKmune 的一個簡單問題。

I think I heard earlier that potential to move towards renal cancer next depending on resources, of course.

當然，我想我早些時候聽說過下一步發展為腎癌的潛力取決於資源。

But is that selection of renal cancer have similarities to prostate cancer choice in terms of there seems to be a higher proportion of NK cells versus T cells in those tumor types?

但是，腎癌的選擇與前列腺癌的選擇是否有相似之處，因為這些腫瘤類型中 NK 細胞與 T 細胞的比例似乎更高？

Absolutely.

絕對地。

So there's a long history.

所以有很長的歷史。

I mean, last week I was examining a PhD student at the Karolinska who spent four years looking at the same issue.

我的意思是，上週我正在研究卡羅林斯卡醫學院的博士生，他花了四年的時間研究同一個問題。

And yes, renal cell cancer is thought typically heavily infiltrated with NK cells.

是的，腎細胞癌通常會被 NK 細胞大量浸潤。

And as a prognostic benefit to those patients who have a high NK cell infiltrate.

對於 NK 細胞浸潤較高的患者來說，這可以帶來預後益處。

And infact there's a negative and prognostic effect of having a high CD8 T-cell infiltrate.

事實上，高 CD8 T 細胞浸潤會產生負面影響和預後影響。

And of course, the drugs that have been approved for renal cell cancer NK targeting often failed in IL-2.

當然，已批准用於腎細胞癌 NK 標靶的藥物通常在 IL-2 方面失敗。

So yes, that's really the rationale behind that.

是的，這確實是背後的基本原理。

And we've got some very nice data to demonstrate that to NK cells do target renal cell carcinoma cell lines better after they've been primed to INKmune.

我們得到了一些非常好的數據來證明 NK 細胞在接受 INKmune 處理後確實可以更好地靶向腎細胞癌細胞系。

Got it.

知道了。

Thank you, David.

謝謝你，大衛。

Daniel Carlson, Tailwinds Research.

丹尼爾·卡爾森，Tailwinds Research。

Guys, and thanks for taking my question.

夥計們，感謝您提出我的問題。

R.J, just you'd talk about hopefully showing it flat on cognition as opposed to steep decline in the placebo group.

R.J，您剛才提到希望在認知方面表現出持平，而不是安慰劑組的急劇下降。

I'm wondering if you do put up those type of numbers, is there any chance that conditional approval post the Phase 2?

我想知道您是否確實提供了這些類型的數字，第二階段是否有可能有條件批准？

Yes.

是的。

Right.

正確的。

Your lips to god's ears.

你的嘴唇貼近上帝的耳朵。

I do as much as the FDA has tortured us.

FDA 折磨我們的事情我都做了。

I do believe in general, the FDA has their heart in the right place.

我確實相信，總的來說，FDA 的用心是正確的。

And if the results are extraordinary and I would consider that an extraordinary result.

如果結果是非凡的，我會認為這是一個非凡的結果。

Not only will investors be excited.

不僅投資者會感到興奮。

Not only will the company be excited but the FDA gets excited.

不僅公司會興奮，FDA 也會興奮。

And who knows what will happen,Dan.

誰知道會發生什麼，丹。

They will do they will pull out all the stuff to help push us along.

他們會拿出所有的東西來幫助推動我們前進。

I don't know what that looks like, but they get excited about groundbreaking data just like you and I do.

我不知道那是什麼樣子，但他們就像你我一樣對突破性的數據感到興奮。

So you know, is there a chance?

那你知道，還有機會嗎？

Yes, would I bet more than a steak dinner on it?

是的，我會賭它比牛排晚餐還要多嗎？

At this point, no.

在這一點上，沒有。

But man, if we knock it out of the park, I think all bets are off.

但是，夥計，如果我們成功了，我想所有的賭注都會落空。

We'll just have to see what they say.

我們只需看看他們怎麼說。

Patient advocacy groups make a big difference with the FDA.

患者權益團體對 FDA 的影響很大。

The Alzheimer's field or the Alzheimer's advocacy groups, although there are a lot of patients are not particularly vocal compared to some of the other indications which are smaller such as ALS and DMD.

阿茲海默症領域或阿茲海默症倡導團體，儘管與其他一些較小的適應症（如 ALS 和 DMD）相比，並沒有特別發聲。

I don't know, it's a great question.

我不知道，這是一個很好的問題。

I like to dream about it, but I'm not going to hold my breath, Dan.

我喜歡做夢，但我不會屏住呼吸，丹。

Okay.

好的。

And just sort of a follow-up on that.

這只是對此的後續行動。

What about other jurisdictions?

其他司法管轄區又如何呢？

Are they all going to fall in line behind the FDA or might it get approved on those results elsewhere?

他們是否都會跟隨 FDA 的腳步，還是可能會根據其他地方的這些結果獲得批准？

I hesitate to ask that question because, you know, each of them is a little bit different.

我猶豫是否要問這個問題，因為，你知道，他們每個人都有一點不同。

I think the MHRA tends to be one that I think has a little more independent thinking.

我認為 MHRA 往往是一個具有更多獨立思考能力的機構。

The EMA tends to think very much like the FDA and we certainly haven't seen a lot of innovation of regulatory innovation and Alzheimer's disease.

EMA 的思維方式往往與 FDA 非常相似，我們當然還沒有看到很多監管創新和阿茲海默症的創新。

But I have to say some of that is just because they haven't had many swings at the ball right.

但我不得不說，其中一些原因只是因為他們在球權上沒有太多揮桿。

Then for all practical purposes, the only drugs that have come through or are the anti amyloids and that's kind of they all look pretty much the same.

然後，出於所有實際目的，唯一已經通過的藥物是抗澱粉樣蛋白，它們看起來幾乎都一樣。

I don't know, we'll see.

我不知道，我們拭目以待。

And I think that let's we need right now to get there Phase 2 enroll number one, we need to get it analyzed.

我認為我們現在需要進入第二階段，首先註冊，我們需要對其進行分析。

And then when we see that top line data, then we'll both have the resources and the insight to move as quickly as we can and believe me, we'll be making every attempt we can to move quickly.

然後，當我們看到最重要的數據時，我們都將擁有資源和洞察力來盡快採取行動，相信我，我們將盡一切努力快速採取行動。

Yes, that's great.

是的，那太好了。

I look forward to seeing what happens when you ring the bell there.

我期待著看到當你按下那裡的門鈴時會發生什麼。

So I just have one question about TRD.

我只有一個關於 TRD 的問題。

Now that you've got some more capital in and can you just sort of refresh the timeline and you get more resources to put there and tell us more about this trial when we could expect something out of it?

現在你已經有了更多的資金，你能不能刷新一下時間表，並獲得更多的資源來放在那裡，並在我們可以期待從中得到什麼的時候告訴我們更多關於這次試驗的信息？

Yes, expect something out of that one.

是的，期待從中得到一些東西。

Once again, it's a blindly randomized, placebo-controlled file.

這又是一個盲目隨機、安慰劑對照的文件。

So actually getting data the first thing you're going to hear is that, this is the way it will go.

因此，實際上在獲取數據時，您首先聽到的是，這就是它的發展方向。

The FDA will announce that the FDA has accepted that the IND and the trial is open.

FDA 將宣布 FDA 已接受 IND 且試驗已開放。

First patient enrolled, and then we'll be moving it forward.

第一個患者註冊，然後我們將繼續前進。

The amount of the speed of the trial will directly be related to how much resources we can put behind it.

審判速度的快慢，直接關係到我們能投入多少資源。

Right now, the NIH grant only funds about a third of the trial.

目前，美國國立衛生研究院的撥款僅資助了約三分之一的試驗。

So we have to be careful because our primary mission, as we've said, is number one, Alzheimer's and then number two, the INKmune CaRePC.

所以我們必須小心，因為正如我們所說，我們的首要任務是第一任務：阿茲海默症，然後是第二任務：INKmune CaRePC。

But we think we'll be able to move that ahead.

但我們認為我們能夠推動這項進程。

And as our resources expand, we'll be able to put the pedal through the metal on treatment resistant depression.

隨著我們的資源不斷擴大，我們將能夠全力治療難治性憂鬱症。

But this year, the two milestones you should hear from, as David said, is that the FDA has allowed us to open the IND because it is a US trial.

但今年，正如 David 所說，您應該聽到的兩個里程碑是 FDA 允許我們開放 IND，因為這是一項美國試驗。

And the second thing will be the first patient enrolled.

第二件事將是第一位入組的患者。

That's our goal.

這就是我們的目標。

And that will conclude today's question-and-answer session.

今天的問答環節就到此結束。

I will now turn the conference over to R.J for any additional closing remarks.

現在，我將把會議轉交給 R.J，讓其發表更多閉幕詞。

Well, thank you, and with the success of the fundraising, we now have the capital to comfortably complete AD02, THE early Alzheimer's trial and support CaRePC into some of the open label data in metastatic castrate-resistant prostate cancer.

好的，謝謝，隨著籌款的成功，我們現在有資金輕鬆完成早期阿茲海默症試驗 AD02，並支持 CaRePC 獲得轉移性去勢抵抗性前列腺癌的一些開放標籤數據。

Our goal is to provide positive readout in these problems.

我們的目標是對這些問題提供正面的解讀。

With positive readouts we expect will be able to access capital markets in a way to allow the company to become more aggressive and pursuing its goals.

憑藉積極的數據，我們預計將能夠進入資本市場，從而使公司變得更加積極進取並追求其目標。

Both of these products have uses beyond their primary indications.

這兩種產品的用途超越了其主要適應症。

We believe that with the resources with -- given the resources we hope to get we have the expertise in the management capitalized on these other activities either alone or with partners.

我們相信，鑑於我們希望獲得的資源，我們擁有管理方面的專業知識，可以單獨或與合作夥伴一起利用這些其他活動。

For now we appreciate your support.

目前，我們感謝您的支持。

Thank you very much.

非常感謝。

This does conclude today's conference call.

今天的電話會議到此結束。

Thank you for your participation.

感謝您的參與。

You may now disconnect.

您現在可以斷開連線。