INmune Bio Inc (INMB) 2025 Q3 法說會逐字稿

Greetings and welcome to the INmune bio Third quarter, 2025 earnings call. (Operator Instructions)As a reminder, this conference is being recorded. A transcript will follow within 24 hours of this conference call. At this time, it is my pleasure to introduce Mr. Daniel Carlson, head of investor relations of Indian Bao. Daniel.

大家好，歡迎參加 INmune bio 2025 年第三季財報電話會議。（操作說明）提醒：本次會議正在錄音。本次電話會議結束後24小時內將提供會議記錄。在此，我很高興向大家介紹印度寶集團投資者關係主管丹尼爾‧卡爾森先生。丹尼爾。

Thank you, operator, and good afternoon, everyone. We thank you for joining us for the call for INmune BIO's third quarter 2025 financial results. Presenting on today's call are David Moss, CEO and co-founder of INmune Bio, Doctor Mark Ladell, Chief Scientific Officer and co-founder of INmune Bio, Doctor Christopher Barnum, head of neuroscience, and Corey Ellspermann, Immune bio-CFO.

謝謝接線員，大家下午好。感謝您參加 INmune BIO 2025 年第三季財務業績電話會議。今天出席電話會議的有：INmune Bio 執行長兼聯合創始人 David Moss、INmune Bio 首席科學官兼聯合創始人 Mark Ladell 博士、神經科學負責人 Christopher Barnum 博士以及 Immune Bio 財務長 Corey Ellspermann。

Before we begin, I remind everyone that except for statements of historical fact, the statements made by management and responses to question on this conference call are forward-looking statements under the safe harbour provisions of the Private Securities Litigation Reform Act of 1995. These statements involve risks and uncertainties that can cause actual results to differ material from those such as forward-looking statements.

在會議開始之前，我要提醒大家，除歷史事實陳述外，管理層在本次電話會議上所作的陳述以及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。這些聲明涉及風險和不確定性，可能導致實際結果與前瞻性聲明等預期結果有重大差異。

Please see the forward-looking statements disclaimer on the company's earnings press release, as well as risk factors on in the company's SEC filings, including our most recent quarterly filings with the SEC. There is no assurance of any specific outcome.

請參閱本公司獲利新聞稿中的前瞻性聲明免責聲明，以及本公司向美國證券交易委員會提交的文件（包括我們最近向美國證券交易委員會提交的季度文件）中的風險因素。無法保證任何具體成果。

Undue reliance should not be placed on forward-looking statements which speak only as of the date they are made, as the facts and circumstances underlying these forward-looking statements may change. Except as required by law, Indian bio disclaims any obligation to update these forward-looking statements to reflect future information, events, or circumstances.

不應過度依賴前瞻性陳述，因為這些前瞻性陳述所依據的事實和情況可能會發生變化，這些陳述僅代表其作出之日的情況。除法律要求外，Indian bio 不承擔任何義務更新這些前瞻性聲明以反映未來的資訊、事件或情況。

It's now my pleasure to turn the call over to CEO David Moss. David?

現在我很高興將電話交給執行長大衛·莫斯。大衛？

Thank you, Dan, and good afternoon, everyone. For a third quarter of 2025 call today, I will review key takeaways and provide an update on our platform programs. Following my review of the recent developments at INmune Bio, I will pass the microphone to Dr. Lodell, INmune Bio's Chief Scientific Officer and inventor of Nordstrom, who will provide an update on our Nordstrom MSC platform and particularly our [RD] [REV] program along with INmune .

謝謝你，丹，大家下午好。在今天舉行的 2025 年第三季電話會議上，我將回顧重點，並介紹我們平台專案的最新進展。在回顧了INmune Bio的最新進展之後，我將把麥克風交給INmune Bio的首席科學官兼Nordstrom的發明者Lodell博士，他將介紹我們的Nordstrom MSC平台，特別是我們與INmune合作的[RD][REV]專案的最新進展。。

Next, Dr. CJ Barnum, who leads our CNS drug development efforts, will provide an update on the Alzheimer's program, and then Corey Ellspermann, our CFO, will present our financial results, after which I'll conclude our prepared remarks with a review of our upcoming catalyst, and then we'll be happy to take your questions.

接下來，負責中樞神經系統藥物研發工作的 CJ Barnum 博士將介紹阿茲海默症計畫的最新進展，然後我們的財務長 Corey Ellspermann 將介紹我們的財務業績，之後我將回顧我們即將推出的催化劑，結束我們準備好的發言，然後我們很樂意回答大家的問題。

Since taking over the role of CEO at INmune Bio in July, it's been a time of transition for the company. Having spent the last two years with our main focus on Alzheimer's trial, which ended in late June, we're now able to direct our attention to the next stage of development for our platform drug programs. And we're highly optimistic that the next couple of years will demonstrate the success of our efforts as we take our programs through key development milestones which we expect could lead to benefits not only for investors but for patients suffering from diseases with limited therapeutic options available at this time.

自 7 月接任 INmune Bio 執行長一職以來，該公司一直處於轉型期。過去兩年，我們主要專注於阿茲海默症試驗，該試驗已於六月下旬結束。現在，我們可以將注意力集中到我們平台藥物專案的下一階段開發中。我們非常樂觀地認為，未來幾年我們將取得成功，因為我們的計畫將經歷關鍵的發展里程碑，我們預計這不僅會為投資者帶來好處，也將為目前治療選擇有限的疾病患者帶來好處。

Cordstrom is our most advanced program as we are now in the process of preparing for submission for marketing approval to the regulatory bodies in both the UK and the US. We believe Cordstrom has demonstrated a clear and safe benefit to patients suffering from recessive dystrophic epidermolysis bullosa, also referred to as RDEB, a very debilitating disease.

Cordstrom 是我們最先進的項目，我們目前正在準備向英國和美國的監管機構提交上市許可申請。我們相信，Cordstrom 已證明對患有隱性營養不良性大皰性表皮鬆解症（也稱為 RDEB，一種非常嚴重的致殘性疾病）的患者俱有明顯且安全的益處。

Patients on the drug had a significantly reduced itch, which not only affects wound healing in these young sufferers, but also reduces the itch, scratch, wound cycle. While RDEB primarily manifests as a as a genetic condition causing skin fragility, blistering and scarring due to the mutations of the collagen 7 gene, it also involves mucous membrane and internal organs, leading to multi-system complications.

服用該藥物的患者搔癢症狀明顯減輕，這不僅影響了這些年輕患者的傷口癒合，而且還減少了搔癢、抓癢、傷口癒合的惡性循環。雖然 RDEB 主要表現為一種遺傳性疾病，由於膠原蛋白 7 基因突變導致皮膚脆弱、起水泡和疤痕，但它也涉及黏膜和內臟器官，導致多系統併發症。

While RDEB has traditionally been treated topically, RDEB is a systemic disease that has blisters and scarring in the mouth, Esophagus, eyes, urethra. And anal area causing nutritional deficiencies, emotional stress, and other problems. We believe Cordstrom is potentially one of the first systemic treatments for RDEB. And made an improvement in the quality of life of the patients treated in our trial.

雖然 RDEB 傳統上採用局部治療，但 RDEB 是一種全身性疾病，會在口腔、食道、眼睛、尿道出現水皰和疤痕。肛門區域也會導致營養不良、情緒壓力和其他問題。我們認為 Cordstrom 有可能成為治療 RDEB 的首批系統性療法之一。並且改善了我們試驗中接受治療的患者的生活品質。

Looking beyond our initial indications are that we believe Cordstrom is a platform opportunity for immune bile, as it has the potential to accomplish all sorts of things in many different diseases. For example, we can genetically modify it to treat cancer cells, which is what it was originally developed for, and there are many other modifications you will hear about in the near future.

除了我們最初的跡象之外，我們認為 Cordstrom 是一個免疫膽汁的平台機會，因為它有可能在許多不同的疾病中實現各種各樣的目標。例如，我們可以對其進行基因改造來治療癌細胞，這正是它最初被開發的目的，而且在不久的將來你還會聽到許多其他的改造。

So there's a lot of things that we can do with Cordstrom to improve its targeting and a variety of rare diseases and indeed less rare or more common diseases.

因此，我們可以利用 Cordstrom 做很多事情來改善其靶向性，從而治療各種罕見疾病，以及不太罕見或更常見的疾病。

I will be excited to share these modifications in the future as well as expansions towards other indications. Turning to the expo platform, we remain confident in its potential to treat neural inflammation in Alzheimer's disease. In September, we submitted a manuscript detailing the results of the phase 2 mindful trial for peer review publication. As we analysed the complete data set, we're gaining deeper insight into the drug's activity.

未來我將很高興與大家分享這些改進，以及在其他適應症的拓展。就博覽會平台而言，我們仍然對其治療阿茲海默症神經發炎的潛力充滿信心。9 月，我們提交了一份手稿，詳細介紹了 2 期正念試驗的結果，以供同行評審發表。透過分析完整的資料集，我們對該藥物的活性有了更深入的了解。

Dr. Barnum will elaborate. Our finding, we'll elaborate, but our findings indicate positive results in patients with higher baseline inflammation. We're actively pursuing an accelerated regulatory pathway and preparing for our end of phase two meeting with the FDA. Defining a clear path forward for explore is a primary objective and may be crucial for strategic funding and partnership discussions.

巴納姆博士將對此進行詳細闡述。我們的發現，我們將在後文詳細闡述，但我們的發現表明，基線發炎程度較高的患者會取得積極的治療效果。我們正在積極尋求加快監管審批的途徑，並準備與美國食品藥物管理局 (FDA) 召開第二階段結束會議。為探索專案製定明確的前進方向是首要目標，對於策略性資金和合作夥伴關係的討論可能至關重要。

2025 also saw us complete the phase two trial of [incommune] and prostate cancer ahead of schedule. With the primary endpoint and two of the three secondary endpoints met, I'm excited to have Mark share more and later.

2025 年，我們也提前完成了 [incommune] 和前列腺癌的第二期試驗。主要終點和三個次要終點中的兩個都已達到，我很高興稍後能請 Mark 分享更多資訊。

To conclude my remarks before I turn the call over to the team to discuss the individual programs, I'd like to thank the patients that participated in our trials, the clinical trial sites. And our dedicated team for helping us execute these very complex trials. I also want to thank our investors for their continued belief in our novel platforms and support.

在將電話交給團隊討論各個項目之前，我想總結一下我的發言，並感謝參與我們試驗的患者和臨床試驗中心。也要感謝我們敬業的團隊，他們幫助我們執行了這些非常複雜的試驗。我還要感謝我們的投資人一直以來對我們創新平台的信任與支持。

Our decision to develop three every different drug platform in parallel to provide strength and opportunity has borne fruit. INmune now has 2 later stage platform therapeutics that have demonstrated success in clinical trials and are ready to advance to the next stage of development, and a third which completed a phase 2 trial successfully. Our value proposition to shareholders and patients is clear.

我們決定並行開發三種不同的藥物平台，以增強實力和提供機會，這項決定已經取得了成果。INmune 目前擁有 2 種後期平台療法，已在臨床試驗中取得成功，並準備進入下一階段的開發；還有一種療法已成功完成 2 期試驗。我們向股東和患者提供的價值主張很明確。

First is to get Cordstrom to MAA in the UK, followed by a BLA in the US. Meanwhile, for Expro, we await regulatory alignment with the end of phase 2 study to determine next steps. We anticipate all of this will happen in 206, an exciting year for the company.

首先是讓 Cordstrom 獲得英國 MAA 的批准，然後是美國的 BLA 批准。同時，對於 Expro，我們正在等待監管部門與 2 期研究的最終結果達成一致，以確定下一步。我們預計這一切都將在 2006 年發生，這將是公司激動人心的一年。

Now I'll turn the car over to Mark. Call over to Mark Liddell for more color on cords for me in, Mark.

現在我把車交給馬克。馬克，請馬克·利德爾過來，幫我補充一些關於線纜的顏色資訊。

Good afternoon, everybody and thank you David for the introduction. As you've heard, we're progressing towards drug registration firstly in the UK and then the US with Cordstrom in our Deb as our initial indication, whilst developing other indications for the platform at the same time.

大家下午好，謝謝大衛的介紹。如您所知，我們正在推動藥物註冊工作，首先在英國，然後在美國，Cordstrom 是我們最初的適應症，同時我們也在開發該平台的其他適應症。

This is a truly debilitating disease which presents itself in the first months of life and for which there is no cure currently. The median survival for those with severe disease is fewer than 30 years. And although skin wounds are the most apparent manifestations of the disease, the lesions, as David has told you, are present throughout the gastrointestinal tract inside the nose, and behind the eyes. The disease is driven by inflammation, and CORDStrom provides systemic suppression of inflammation.

這是一種非常嚴重的疾病，通常在出生後的頭幾個月出現，目前尚無治癒方法。重症患者的中位存活期不足30年。雖然皮膚傷口是這種疾病最明顯的表現，但正如大衛告訴你的那樣，病灶遍布整個消化道、鼻子內部和眼睛後面。該疾病是由發炎引起的，而 CORDStrom 可係統性地抑制發炎。

Most importantly, CORDStrom is most effective when activated by the inflammatory cytokines at the sites, so its effect is somewhat targeted. During the Mission EB randomized placebo-controlled trial in the UK, over 120 infusions of CORDStrom were administered to over 30 children without any severe adverse reactions or adverse events.

最重要的是，CORDStrom 在被病灶部位的發炎細胞激素活化時效果最佳，因此其作用具有一定的標靶性。在英國進行的 Mission EB 隨機安慰劑對照試驗中，超過 30 名兒童接受了超過 120 次 CORDStrom 輸注，沒有任何嚴重不良反應或不良事件。

As David has said, reduction in systemic itch was a major reported benefit by patients, some as young as 2 years old who used a cartoon depiction of whole-body itch to demonstrate their experience severity. It control is important because the resulting scratch initiates new skin wounds and increases risk of infection, which is part of the disease cycle, and I can't emphasize how much important, how very important itch is to these children as it drives a vicious itch, scratch, wound cycle that impairs wound healing by separating skin layers and forming new blisters.

正如大衛所說，全身搔癢的減輕是患者報告的主要益處，有些患者甚至只有 2 歲，他們用卡通描繪全身搔癢來表示他們所經歷的嚴重程度。控制搔癢非常重要，因為由此產生的抓癢會引發新的皮膚傷口，增加感染的風險，而感染是疾病循環的一部分。我無法強調搔癢對這些孩子來說有多重要，它引發了搔癢、抓癢、傷口的惡性循環，透過分離皮膚層和形成新的水皰來損害傷口癒合。

These rupture easily, creating open wounds or exacerbating existing wounds, delaying healing and creating this terrible feedback loop. It's painful for these for these children with intense itch, causing a poor quality of life with distress, sleep loss, and emotional burden. Breaking this itch scratch wound habit is difficult and highlights one of the special aspects of CORDStrom.

這些傷口很容易破裂，造成開放性傷口或加重現有傷口，延緩癒合，並形成這種可怕的回饋循環。對這些孩子來說，劇烈的搔癢會讓他們感到痛苦，導致生活品質下降，並帶來痛苦、睡眠不足和精神負擔。戒掉這種抓傷傷口的習慣很困難，這也凸顯了 CORDStrom 的一個特殊面向。

[Miss] B was an investigator led trial. It wasn't sponsored or funded by INmune . We secured access to the entire trial data pack in August and have appointed an independent group of clinical statisticians to analyse all of the data in depth.

B 小姐是調查員主導的審判。它並非由INmune贊助或資助。。我們在 8 月獲得了整個試驗資料包的存取權限，並任命了一個獨立的臨床統計學家小組對所有數據進行深入分析。

This is critical for our submission to regulatory agencies and is well underway. In the trial, all patients received both Cordstrom and placebo, separated by 6 months. Some treated first with placebo and then Cordstrom, and the other half treated with Cordstrom first and then placebo. These in-depth analyses of these data show improvements in disease activity scores in all patients' subgroups after Cordstrom compared to their previous placebo treatment.

這對於我們向監管機構提交文件至關重要，目前工作進展順利。在試驗中，所有患者均接受了 Cordstrom 和安慰劑治療，兩次治療間隔 6 個月。一部分患者先接受安慰劑治療，然後接受 Cordstrom 治療；另一部分患者先接受 Cordstrom 治療，然後接受安慰劑治療。對這些數據的深入分析表明，與先前的安慰劑治療相比，Cordstrom 治療後所有患者亞組的疾病活動評分均有所改善。

In preparation for registration filing, Immune in the UK has now relocated into rented CGMP manufacturing space, which is compliant with commercial production as a licensed medicine. We successfully completed the technology transfer earlier this month and we're on track to be ready for UK filing at the end of Q2 next year. Alongside the CGMP work we're confirming the complex mechanisms of action of Cordstrom in ADEB and validating assays to test drug batches at the end of manufacture.

為了準備註冊申請，英國的 Immune 公司現已搬遷至租用的符合 CGMP 標準的生產場所，該場所符合獲批藥品的商業生產要求。本月初我們成功完成了技術轉讓，目前一切進展順利，預計在明年第二季末向英國提交申請。在進行 CGMP 工作的同時，我們正在確認 Cordstrom 在 ADEB 中的複雜作用機制，並驗證在生產結束時測試藥物批次的檢測方法。

This work is Very critical since FDA and other agencies require robust tests of drug potency, and failures to get this right with cellular drugs have delayed other drug approvals for many years. This year also saw the completion of the phase 2 aspect of our trial of in commune in patients with castration resistant prostate cancer.

這項工作至關重要，因為 FDA 和其他機構要求對藥物效力進行嚴格的測試，而細胞藥物在這方面的失誤已經導致其他藥物的審批延遲多年。今年，我們也完成了去勢抵抗性前列腺癌患者的共同試驗的第二階段。

As David said, we met the primary endpoint of the trial in Q1 of this year, and analysis of the 1st 9 patients showed evidence of NK cell proliferation in vivo and generation of the functional memory-like NK cells that we understand in generates in 4 of the 6 patients treated at the lowest and intermediate dose levels.

正如大衛所說，我們在今年第一季達到了試驗的主要終點，對前 9 名患者的分析顯示，體內有 NK 細胞增殖的證據，並且產生了我們了解到的功能性記憶樣 NK 細胞，在接受最低和中等劑量治療的 6 名患者中的 4 名中產生了這種細胞。

The data from the patients in the highest dose cohort are awaiting analysis, but the team is tied up with Cordstrom at the moment. Thus, two of the secondary end points were met. The final secondary endpoint was reduction in tumour load, and our primary measure was PSMA PET scans. But it was obvious from the analysis of the 1st six subjects that the patients being enrolled had very high disease burden beyond that which would respond to immunotherapy.

最高劑量組患者的數據尚待分析，但目前團隊正忙於科德斯特羅姆的研究。因此，兩個次要終點均已達到。最終次要終點是腫瘤負荷的減少，而我們的主要測量指標是 PSMA PET 掃描。但從前六名受試者的分析中可以明顯看出，入組患者的疾病負擔非常重，超出了免疫療法所能達到的程度。

We thus decided that since we'd met the primary and two of the secondary endpoints at both low and intermediate doses, we had identified the dose to take forward to randomize phase 2 trial and so we could close the current trial to recruitment. We're analysing the blood samples and the PET scans from the final 3 patients at present, and we'll report them to you as soon as they become available. Now we plan to work on the design of the randomized trial during 2026 as resources become available.

因此，我們決定，既然我們已經在低劑量和中等劑量下達到了主要終點和兩個次要終點，我們就確定了要進行隨機 2 期試驗的劑量，因此我們可以結束目前的試驗招募。我們目前正在分析最後 3 名患者的血液樣本和 PET 掃描結果，一旦結果出來，我們會立即向您報告。現在我們計劃在 2026 年資源到位後，著手設計隨機試驗。

Though 2025 has been incredibly busy for the UK team in supporting both INmune and Cordstrom, but all the staff remain fully dedicated to delivering the goals we've set, and we look forward to providing more good news as the data become available.

儘管 2025 年英國團隊在支持 INmune 和 Cordstrom 方面非常忙碌，但所有員工仍然全力以赴地實現我們設定的目標，我們期待著隨著數據的公佈帶來更多好消息。

Now I'll hand over to Christopher Barnum to report on the company's progress with XPro and look forward to any questions later in the call.

現在我將把發言權交給克里斯托弗·巴納姆，讓他匯報公司在 XPro 方面的進展，並期待在稍後的電話會議中回答大家的任何問題。

Thank you, Mark, and good afternoon, everyone. We have established four strategic priorities for expo.

謝謝你，馬克，大家下午好。我們為世博會制定了四項策略重點。

First, to secure regulatory alignment with the FDA at our forthcoming end of phase 2 meeting. Second, to pursue an accelerated approval pathway. Third, to publish comprehensive insights from our phase 2 mindful trial. And 4th, to advanced discussions with potential partners to support late-stage clinical development.

首先，在即將召開的 2 期臨床試驗結束會議上，確保與 FDA 的監管要求保持一致。其次，尋求加速審批途徑。第三，公佈我們 2 期正念試驗的全面見解。第四，與潛在合作夥伴進行深入討論，以支援後期臨床開發。

During the third quarter, we achieved an important milestone by submitting the phase 2 mindful trial results for peer reviewed publication. A pre-print manuscript is now available on MTRX, providing the scientific community and our stakeholders with expanded insights.

第三季度，我們取得了一項重要里程碑，即提交了 2 期正念試驗結果以供同儕審查發表。預印本手稿現已在 MTRX 上發布，為科學界和我們的利益相關者提供更深入的見解。

While much of the data has been previously presented, this manuscript introduces new analysis from the dose compliant patient set. These are patients who received at least 21 of the 23 scheduled doses. This population reflects the impact of sustained therapy and has been recognized by the FDA as a potential indicator of disease modifications. The findings demonstrate that longer treatment durations with XPro are associated with greater improvements in neuropsychiatric symptoms and biomarkers, including PTA 217 and GFAP.

雖然在許多數據之前已經發表過，但本文介紹了來自劑量符合患者集的新分析。這些患者至少接受了 23 次預定劑量中的 21 次。此族群反映了持續治療的影響，並已被美國食品藥物管理局 (FDA) 認定為疾病改變的潛在指標。研究結果表明，使用 XPro 治療的時間越長，神經精神症狀和生物標記（包括 PTA 217 和 GFAP）的改善程度就越大。

We continue to build a robust evidence base to advanced analysis of neuroimaging endpoints. These focus on white matter integrity, an indicator of myelin preservation, and grey matter metrics related to neurodegeneration. Emerging results are expected to further substantiate XPro's potential as a differentiated disease modifying therapy, and we plan to share these findings as they become available.

我們持續建構強大的證據基礎，以推進神經影像終點的分析。這些研究主要關注白質完整性（髓鞘保存的指標）和與神經退化性變相關的灰質指標。預計後續的研究結果將進一步證實 XPro 作為一種差異化的疾病修飾療法的潛力，我們將在研究結果公佈後與大家分享。

There remains substantial unmet need beyond existing anti amyloid treatments, particularly for patients with a strong inflammatory profile or those unable to receive anti amyloid therapies due to safety concerns such as Area. XPro is uniquely positioned to address this GAAP, as no area-related safety signals were observed, even among high-risk individuals.

除了現有的抗澱粉樣蛋白治療外，仍有大量未滿足的需求，特別是對於發炎症狀較重的患者或因安全問題（如 Area）而無法接受抗澱粉樣蛋白治療的患者。XPro 具有獨特的優勢來應對此 GAAP，因為即使在高風險族群中，也沒有觀察到與區域相關的安全訊號。

Despite the challenges inherent in Alzheimer's drug development, XPro continues to distinguish itself through its targeted patient selection, compelling safety profile, and growing body of evidence.

儘管阿茲海默症藥物研發面臨諸多挑戰，但 XPro 憑藉其精準的患者選擇、令人信服的安全性能和不斷增長的證據體系，持續脫穎而出。

Our disciplined, data-driven approach which prioritizes scientific rigor, regulatory engagement, and financial responsibility, supports the long-term goal of establishing XPro as a transformative therapy and delivering sustained value to patients, partners, and shareholders. We look forward to providing ongoing updates as we advance toward key clinical and regulatory milestones. I will now turn it over to Corey for the financial update.

我們秉持嚴謹、數據驅動的方法，優先考慮科學的嚴謹性、監管參與和財務責任，支持將 XPro 打造成變革性療法並為患者、合作夥伴和股東帶來持續價值的長期目標。我們將持續更新最新進展，以協助我們邁向關鍵的臨床和監管里程碑。接下來我將把財務報告交給科里。

Thank you, CJ. At this time, I'll provide a brief overview of our financial results.

謝謝你，CJ。此時，我將簡要地概述一下我們的財務表現。

Net loss attributable to common stockholders for the quarter ended September 30, 2025, was approximately $6.5 million compared with approximately $12.1 million for the comparable period in 2024. Research and development expenses totalled approximately $4.9 million for the quarter ended September 30, 2025, compared with approximately $10.1 million for the comparable period in 2024.

截至 2025 年 9 月 30 日止季度，歸屬於普通股股東的淨虧損約為 650 萬美元，而 2024 年同期約為 1,210 萬美元。截至 2025 年 9 月 30 日的季度，研發費用總計約為 490 萬美元，而 2024 年同期約為 1,010 萬美元。

General and administrative expenses were approximately $2.5 million for the quarter ended September 30, 2025, compared with approximately $2.2 million for the comparable period in 2024. On September 30, 2025, the company had cash and cash equivalents of approximately $27.7 million, and based on our current operating plan, we believe our cash is sufficient to fund our operations into Q4 2026.

截至 2025 年 9 月 30 日的季度，一般及行政費用約為 250 萬美元，而 2024 年同期約為 220 萬美元。截至 2025 年 9 月 30 日，本公司擁有現金及現金等價物約 2,770 萬美元，根據我們目前的營運計劃，我們認為我們的現金足以支持我們的營運直至 2026 年第四季。

As of October 30th, 2025, the company had approximately $26.6 million shares of common stock outstanding.

截至 2025 年 10 月 30 日，該公司已發行約 2,660 萬美元的普通股。

Now I'll pass it back to David.

現在我把它交還給大衛。

Thank you, Corey. Now I'd like to present upcoming milestones for the company, and then we can start the Q&A session.

謝謝你，科里。現在我想介紹一下公司即將取得的里程碑式成就，然後我們就可以開始問答環節了。

For a Cordstrom program, we have a number of significant events in front of us. In Q4 will present additional data from the trial. In mid 2026, we expect to file a marketing authorization application in the UK. A few months after filing the marketing authorization application, we expect to file a BLA (biologic's licensing application) with the FDA. We'd expect to hear back from the FDA sometime by the middle of 2017 or later.

對於科德斯特羅姆計畫來說，我們面前有很多重要事件。第四季將公佈試驗的更多數據。我們預計將於 2026 年中在英國提交上市許可申請。在提交上市許可申請幾個月後，我們預計將向FDA提交BLA（生物製品許可申請）。我們預計在 2017 年年中或之後會收到 FDA 的回覆。

For XPro, we expect to accomplish a lot in the next few quarters. In Q4, we anticipate getting more MRI data conducted during the Mindful trial. With this data, we hope to show improvements in myelin, gray matter, and white matter which would support the cognitive and biomarker findings of XPro benefits that CJ spoke about earlier. We expect to hear from the FDA on accelerated pathways sometime in Q1 of 2026, and we anticipate having the minutes from the end of the phase two meeting sometime in Q1 of 2026. So, a lot happening in 2026.

對於 XPro，我們預計在接下來的幾個季度會取得很多成就。預計在第四季度，我們將獲得更多在 Mindful 試驗期間進行的 MRI 數據。我們希望透過這些數據來證明髓鞘、灰質和白質的改善，這將支持 CJ 先前提到的 XPro 帶來的認知和生物標記益處。我們預計在 2026 年第一季會收到 FDA 關於加速審批途徑的消息，並預計在 2026 年第一季會收到第二階段會議結束的會議紀錄。所以，2026年會發生很多事。

At this point I'd like to hand the call back to the operator to poll for questions.

此時我想把電話轉回接線生，詢問大家是否有問題。

(Operator Instructions) Gary Nachman, Raymond James.

（操作說明）Gary Nachman，Raymond James。

Hey guys, this is Dennis Resnick on for Gary Knopman. Thanks for taking our questions. So just a couple from us. So, on XPro, as you're preparing for this end of phase two meeting with the FDA, can you just walk us through what some of the biggest questions or discussion topics that you're hoping to get more clarity on. And then I believe you were previously saying that the meeting could occur before the year end, and now you're guiding to the meeting occurring in one cue. So could you just speak as to why the flight delay occurred, and I got one follow-up.

大家好，我是丹尼斯·雷斯尼克，今天替加里·諾普曼為大家報道。謝謝您回答我們的問題。我們這裡就舉兩個例子。所以，XPro，在你們準備與FDA進行第二階段結束會議之際，能否請你們簡要介紹一下，你們希望更清楚地了解哪些最重要的問題或討論主題？然後，我相信你之前說過會議可能會在年底前舉行，現在你又暗示會議將在近期舉行。所以能否說明一下航班延誤的原因？我還有一個後續問題。

Yeah, no, I appreciate it, Dennis. Let me start with the second part of your question and then I'll let CJ jump to the first part. We anticipated getting everything together, but we weren't able to get enough of the data in time to really get to the FDA to have the meeting, the end of Q4. I will say though that we're very close. It still could happen. We're going by the end of the date that the FDA puts forward. I don't know what that's going to look like and then keep in mind that you don't get the minutes for the meeting until approximately 30 days after. Our experience with the FDA in the past has been that we usually get it on day 30 or very close to day 30, so we're being relatively conservative, saying in 1, which is the not only the period of time you have the response from the FDA, but the 30 minutes, the 30 days to get the written minutes. CJ, I'll let you respond to the type of questions. I'm not sure we're going to publicly disclose them, but I'll tell you that they relayed around setting up a registration study.

是啊，謝謝你，丹尼斯。讓我先回答你問題的第二部分，然後讓 CJ 直接跳到第一部分。我們原本預計能夠把所有事情都準備好，但是由於時間關係，我們沒能及時收集到足夠的數據，所以無法在第四季末與 FDA 召開會議。不過我可以說，我們關係非常親密。這仍然有可能發生。我們將以FDA提出的截止日期為準。我不知道那會是什麼樣子，而且請記住，會議紀要大約在會議結束後 30 天才能拿到。我們過去與 FDA 打交道的經驗是，我們通常會在第 30 天或非常接近第 30 天的時候收到回复，所以我們比較保守，說 1 天，這不僅是你收到 FDA 回复的時間，還包括收到書面會議紀要的 30 分鐘和 30 天。CJ，我會讓你來回答這類問題。我不確定我們是否會公開披露這些信息，但我可以告訴你，他們曾經四處奔走，籌備一項註冊研究。

Yeah, I mean, I think there's a few obvious ones out there. One of them is that we've talked about quite a bit is EMACC, right? We want to understand the agency's view on EMACC. Another one of the key questions is the enrichment biomarkers. It's clear from our data that the patients that had greater inflammation were the ones that are more likely to respond. And this is somewhat novel in this space, enriching for these biomarkers. So you know these are the sorts of questions that we need to ask. And as David said, because our goal is to really get alignment on how we move this into a registration trial, another key question is the safety database, right? The agency usually requires a certain number of patients to be treated. Prior to, before the drug could be commercialized. So I think, those are sort of the obvious ones. There's some obvious or some other nuanced ones as well, but those are sort of the big questions that I think that we're willing, that we can discuss at this point.

是的，我的意思是，我認為有一些顯而易見的例子。其中一個我們已經討論過很多次的就是 EMACC，對吧？我們想了解該機構對 EMACC 的看法。另一個關鍵問題是富集生物標記。我們的數據清楚地表明，發炎程度越高的患者，治療效果越好。這在這領域具有一定的新穎性，豐富了這些生物標記的研究。所以你知道，這些都是我們需要提出的問題。正如大衛所說，因為我們的目標是真正就如何將其推進到註冊試驗中達成一致，所以另一個關鍵問題是安全資料庫，對吧？該機構通常要求接受治療的患者人數達到某一標準。在此之前，也就是該藥物商業化之前。所以我覺得，這些應該是顯而易見的。當然也有一些顯而易見的問題，或是一些比較微妙的問題，但這些是我們目前願意、可以討論的一些重要議題。

That's super helpful. And then speaking with ex pro on the partnership conversations, can you provide some colors of how those are progressing, or at least maybe compare the tone of the conversations as to where they were at the end of last quarter? And then separately on Incommune, can you just talk a little bit more about how you view the future of that asset? Is this something that you're going to take through development yourself or would you consider partnering this out? Thanks so much, guys.

這太有幫助了。然後，關於與前職業球員的合作洽談，您能否介紹一下這些洽談的進展情況，或者至少比較一下這些洽談與上個季度末的洽談情況？另外，關於 Incommune，您能否再詳細談談您對該資產未來的看法？這個專案你打算自己獨立開發，還是會考慮找合作夥伴？非常感謝各位。

Appreciate it then so. I'll let Mark jump in on me and let me just jump in a little bit further. I think that before we really have aggressive partnering discussions, there's been very top level discussions with a handful of groups. I think like our investors, they want to see what the regulatory feedback and alignment looks like, and on top of that, they want to see more of the data set. I think if we're able to provide. Imaging data, white and gray matter that aligns with what we saw in our highly inflamed patient group. I mean, that's going to be, I think, very compelling. So, we're still gathering all the package together. We want to deliver a complete package where we have really serious discussions.

那麼，請好好珍惜吧。我讓馬克插話進來，然後我也再插話進去一點。我認為，在我們真正展開積極的合作洽談之前，我們已經與少數幾個團體進行了非常高層的討論。我認為，和我們的投資者一樣，他們也想看看監管方面的回饋和調整情況，除此之外，他們還想看到更多的數據集。我認為如果我們能夠提供的話。影像學數據顯示，白質和灰質與我們在高度發炎患者組中觀察到的情況一致。我的意思是，我認為這將會非常有吸引力。所以，我們還在整理所有包裹。我們希望提供一個完整的方案，進行真正嚴肅的討論。

Mark, do you want to comment about anything?

馬克，你有什麼想說的嗎？

Yes, thanks for the question. So, as we've published data on immune potentiating NK responses to a number of different tumours, both Hematological and solid. So, there are plenty of opportunities to take INmune into phase 2 trials now that we've completed one phase 2 trial in other in other disorders and indeed going now into prostate and looking at patients with better risk disease.

是的，謝謝你的提問。因此，我們已經發表了關於增強 NK 細胞對多種不同腫瘤（包括血液腫瘤和實體腫瘤）免疫反應的數據。因此，既然我們已經完成了針對其他疾病的 2 期試驗，並且現在正在研究前列腺疾病，研究風險較高的患者，那麼現在有很多機會將 INmune 推進到 2 期試驗階段。

I'm always very keen to talk to potential. Partners and others that would want to invest in or buy the asset, but I think from our perspective at the moment is to get more phase 2 data in randomized trials in at least prostate and then maybe other diseases as funds become available and then yes indeed look for partnership opportunities in the first instance and potentially keeping it within the company depending upon funding and taking it through to commercial in the way that we're hoping to do with or expecting to do with Cordstrom.

我一直都非常樂意與潛在候選人交流。合作夥伴和其他有意投資或購買該資產的人士，但我認為，就我們目前而言，最重要的是在至少前列腺癌的隨機試驗中獲得更多二期數據，然後隨著資金的到位，可能會擴展到其他疾病。是的，我們首先會尋找合作機會，並有可能根據資金情況將其保留在公司內部，並按照我們希望或預期與 Cordstrom 合作的方式將其商業化。

Great thank you so much. thank you, Mark. Next question please.

非常感謝。謝謝你，馬克。下一個問題。

(Operator Instructions) Jason McCarthy, Maxim Group.

（操作說明）Jason McCarthy，Maxim Group。

Hey guys.

嘿，大家好。

Thanks for the questions or taking the questions. I'm going to concentrate them on the CORDStrom activity. First, has there been any feedback from European regulators, with any specifics you could provide us for potential MAA filing, and do you think if you could file the MAA that would be, further supportive with regulators here in the states?

感謝提問或回答問題。我將讓他們專注於 CORDStrom 活動。首先，歐洲監管機構是否有任何回饋？您能否提供一些關於潛在上市許可申請的具體資訊？您認為如果能夠提交上市許可申請，​​是否會對美國監管機構提供進一步的支援？

So, another good question. So, we're waiting for our scientific meeting with the MHRA. I sit on the British Pharmacopeia, which is part of the MHRA. So, I do get unofficial conversations with colleagues at the agency, and they have been very supportive of us taking this through for scientific advice before the end of the year. So, we're putting that package together and we will submit it as soon as we've got the data from the. The enhanced statistical analyses that are being done at the moment. So I'm expecting early next month to submit the data to the agency for a scientific advice meeting which we may well get before the end of the year, but it's probably going to be early next year and then move ahead with our program. We have contracted a specialist advisory group that work or advisory company called TMC Pharma that Works with rare diseases and has taken a lot of these through the agency and so they're giving us a lot of daily feedback really, they're doing all of our paperwork for that filing to the MHRA and then for the MAA

又是一個好問題。所以，我們正在等待與英國藥品和保健產品監管署 (MHRA) 的科學會議。我擔任英國藥典委員會成員，該委員會隸屬於英國藥品和保健產品監管署 (MHRA)。因此，我與該機構的同事們進行了一些非正式的交流，他們非常支持我們在年底前就此進行科學諮詢。所以，我們正在整理這個資料包，一旦收到數據，就會立即提交。目前正在進行的增強型統計分析。所以我預計下個月初會將數據提交給該機構，以便召開科學諮詢會議。我們很可能在年底前就能收到會議結果，但可能要等到明年初，然後才能繼續推進我們的專案。我們聘請了一家名為TMC Pharma的專業顧問公司，他們專注於罕見疾病領域，並已成功處理過許多罕見疾病藥物的審批流程。他們每天都會給我們很多回饋，並負責我們向英國藥品和保健產品監管署（MHRA）以及上市許可申請（MAA）提交的所有文件。

so, as David said, we are still on track to deliver the MAA submission to the MHRA by Q2 next year and then. And regulatory agencies talk to each other a lot, as I'm sure and none likes to gain say another, so I'm confident that if we address the subtle differences for US use compared to European use and get those data ready in the months after our MOA filing, we'll be in a good position to file a BLA by the end of the year, by which the MHRA will have had their first opportunity. They have their 80 day line to come back to us with comments, and we can any improvements that they come up with, we can put into the FDA document. So I think if we have got an MAA being considered by the UK agency that will feed into the FDA's opinion of the same data, but obviously these are agencies, so. We can't really comment on what they on their activities and the way in which they review other people's data.

所以，正如大衛所說，我們仍然有望在明年第二季向MHRA提交MAA申請，然後。監管機構之間經常溝通，這一點我確信，而且沒有哪個機構喜歡在別人面前佔便宜，所以我相信，如果我們能解決美國使用與歐洲使用之間的細微差別，並在提交 MOA 申請後的幾個月內準備好這些數據，我們就能在年底前順利提交 BLA 申請，屆時 MHRA 也將迎來他們的第一次機會。他們有 80 天的時間向我們回饋意見，我們可以將他們提出的任何改進意見納入 FDA 文件中。所以我認為，如果我們有一份 MAA 正在接受英國監管機構的審查，那麼這將影響 FDA 對相同數據的意見，但顯然這些都是監管機構，所以…我們無法對他們的活動以及他們審查他人數據的方式發表評論。

It's part of that discussion. Thank you, Mark. It's part of that discussion to include. Like at least conversation or anecdotal thoughts around limitations of gene therapy, given that they are topical, there's now two that are on the market, as and potential use in the setting of some of these gene therapies as you'd imagine many of these kids going forward are going to probably try this.

這是討論的一部分。謝謝你，馬克。這是討論的一部分，必須納入其中。就像關於基因療法限制的討論或軼事想法一樣，鑑於它們是熱門話題，目前市面上有兩種，而且在某些基因療法中具有潛在用途，你可以想像，未來很多孩子可能會嘗試這種療法。

Yes, absolutely, but neither of those provide a systemic solution. So, this is what we believe makes Cordstrom unique. But also, the side effects associated with those therapies, one of the major side effects that's reported is itch. So even if it was an additional therapy to address the itch. That isn't addressed by these topical therapies, there's a rationale there for codstrom's use in patients who are potentially being treated with the gene therapies. But as I say, the data we're getting at the moment which once we've got them audited and good enough to share or secure enough to share. Already demonstrating changes in systemic cytokines associated with Strong treatments, so we believe that the strength of this drug will be its ability to have a systemic effect on inflammatory cytokines and therefore downstream as the patients get treated for longer in terms of the overall disease pathway.

是的，當然，但這兩者都不能提供系統性的解決方案。所以，我們認為這就是 Cordstrom 的獨特之處。但這些療法也會帶來副作用，其中一個主要的副作用是搔癢。所以即使它是一種額外的止癢療法。這些局部療法無法解決這個問題，因此對於可能接受基因療法治療的患者來說，使用 codstrom 是有道理的。但正如我所說，我們目前獲得的數據，只有在經過審核並足夠好或足夠安全後才能共享。已經證實，強效治療可以改變系統性細胞因子，因此我們相信，這種藥物的優點在於它能夠對發炎細胞因子產生系統性影響，從而隨著患者接受更長時間的治療，對整個疾病路徑產生下游影響。

And just one mechanistic question, sort of a two part, question. First you had mentioned, can you talk a little bit about the uniqueness of cytokine based activation for Cordstrom once it is given systemically at least in a setting of inflammation like in RD and also the ability to use the Cordstrom platform and tailor it to specific disease types, obviously that would be beyond Rd and how that separates itself from other MSC therapies that are out there.

還有一個機制方面的問題，其實這個問題包含兩個部分。首先您提到，您能否談談 Cordstrom 在全身給藥後，至少在像 RD 這樣的發炎環境下，基於細胞因子的活化的獨特性，以及使用 Cordstrom 平台並將其定制為特定疾病類型的能力（顯然，這超出了 RD 的範疇），以及它與其他 MSC 療法的區別？

Absolutely I could talk for hours on that, but the first question was about inflammation, and we know that for some functions of some MSCs they require what's called licensing, so they need to be activated by inflammatory cytokines and indeed we have evidence in vitro that cause there's a ton of things that caused stem cells do without being activated by inflammatory cytokines, and then there are additional cytokines. And functions that they perform in the presence of inflammatory cytokines. Now, as I'm sure cytokines don't really work systemically in vivo.

當然，我可以就此滔滔不絕地講上幾個小時，但第一個問題是關於發炎的，我們知道某些間質幹細胞的某些功能需要所謂的“許可”，也就是說它們需要被發炎細胞因子激活。事實上，我們在體外實驗中也發現，許多幹細胞在沒有發炎細胞激素活化的情況下也能發揮作用，此外還有其他一些細胞激素。以及它們在發炎細胞激素存在下所發揮的功能。現在，我確信細胞激素在體內並不能真正發揮系統性作用。

They are signalling molecules between cells, and they normally operate over sort of nano distances. But so what we know is that these patients have inflammatory cytokines being generated at the site of itch actually and then the wound. And the itch response is driven by a particular T cell called TH2 releasing a cytokine called I-31, and we know that the Cordstrom suppresses those TH2 cells and suppresses the myeloid cells that are also producing inflammatory cytokines, and they are induced by the inflammatory cytokines that are there.

它們是細胞間的信號分子，通常在奈米尺度上發揮作用。但我們知道，這些患者的搔癢部位以及傷口都會產生發炎細胞激素。搔癢反應是由一種稱為 TH2 的特定 T 細胞釋放一種稱為 I-31 的細胞因子驅動的，我們知道 Cordstrom 會抑制這些 TH2 細胞，並抑制也會產生發炎細胞因子的髓系細胞，而這些細胞是由存在的發炎細胞因子誘導的。

So yes, we think that these cells have a targeted effect in vivo. But your second question was about Cordstrom being used in other indications and what makes Cordstrom truly unique, there are, as you say, many MSCs have been put into trial, and there are at least 3 products which are now licensed around the world, but none of those use 4 MSCs from 4 pool donors. So what we do is we take our amlycal cords, we get them from cord blood.

所以，我們認為這些細胞在體內具有標靶作用。但你的第二個問題是關於 Cordstrom 在其他適應症中的應用，以及 Cordstrom 的真正獨特之處。正如你所說，許多 MSC 都已投入試驗，目前至少有 3 種產品已在全球範圍內獲得許可，但沒有一種產品使用來自 4 個捐贈者的 4 個 MSC。所以我們所做的就是取出我們的無髓臍帶，我們從臍帶血中獲取它們。

Banks in the UK and we isolate the MSCs from those individual courts and then we test them for their various different potencies. So if we know the mechanisms of action we want in a particular disease, we choose 4 chords that have that particular strength in their mechanisms of action, and we pool them. So cordstrom for EB is from 4 pooled donors that we have characterized very well, and we have other donors with the same characteristics which we've also pooled and shown we make the same product. So Cordstrom is one.

英國的銀行，我們從各法院分離出MSC，然後測試它們各種不同的效力。因此，如果我們知道某種特定疾病所需的作用機制，我們會選擇 4 個作用機制具有該特定優勢的和弦，並將它們組合在一起。所以，用於 EB 的 cordstrom 來自 4 個我們已經充分錶徵的混合捐贈者，我們還有其他具有相同特徵的捐贈者，我們也將它們混合在一起，並證明我們生產了相同的產品。所以科德斯特羅姆就是其中之一。

EB is one derivation of Cordstrom, but we can select donors caused with different characteristics that might some of them are specific to chondrocyte interactions and anti-inflammatory responses that could be targeted to osteoarthritis, for example. We've used another pool to treat SLE patients in. In a trial in France which is published, so we can the reason it's a platform is because by selecting different chords it becomes a different drug because the potency data, the potency selection are different and therefore the potency assays and release assays are different. So that's why we're really excited about it as a platform for multiple different different indications.

EB 是 Cordstrom 的衍生類型，但我們可以選擇具有不同特徵的供體，其中一些可能專門針對軟骨細胞相互作用和抗炎反應，例如，可以針對骨關節炎。我們也利用另一個游泳池來治療系統性紅斑狼瘡患者。在法國進行的一項試驗中（該試驗已發表），我們可以看出，它之所以是一個平台，是因為透過選擇不同的和弦，它就變成了一種不同的藥物，因為效力數據、效力選擇不同，因此效力測定和釋放測定也不同。所以，正因如此，我們才對它作為多種不同適應症的平台感到非常興奮。

Sorry, David, a quick one for you. We discussed this, you and I at length a couple of weeks back, but just some high level thoughts of the regulatory environment here, in the states, particularly around MSCs and cell therapy in general because as you guys both know there was one approved the first one in the United States was approved last year for GVHD.

抱歉，大衛，給你一個簡短的問題。幾週前，你我曾詳細討論過這個問題，但這裡只是對美國的監管環境有一些高層次的想法，特別是關於 MSC 和細胞療法的監管環境，因為你們都知道，去年美國第一個獲批的用於治療 GVHD 的藥物就是 MSC。

Could be another filing for heart failure soon and you know where Capricorn is and DMD. And then here you guys are coming with, well, that's not an MSC, but Capricorn is cell therapy. Potentially for our deb next year.

可能很快又會收到一份關於心臟衰竭的申請，你知道 Capricorn 和 DMD 在哪裡。然後你們又說，好吧，那不是間質幹細胞，但 Capricorn 是細胞療法。或許可以作為我們明年的畢業舞會。

I think, the beauty of Mark and his team, and when Mark comes up with an idea, he wouldn't pursue it if he knew that he couldn't manufacture it consistently in large scale to deliver not, dozens of doses or hundreds of doses, but tens of thousands of doses at a commercial scale cost for a for a drug. Whereas a lot of companies, they get in love with the science and they develop a drug, and then they go back if they get approval to figure out how to manufacture it, the manufacturing cost ends up being so high. A lot of it has to do with staff and facilities and time.

我認為，馬克和他的團隊的偉大之處在於，當馬克想出一個主意時，如果他知道自己無法持續地大規模生產，以商業規模的成本提供數萬劑藥物，而不是幾十劑或幾百劑，他就不會去追求這個主意。很多公司對科學充滿熱情，在研發藥物後，即使獲得批准，他們又會回頭去研究如何生產，但最終生產成本卻非常高。許多因素都與人員配備、設施和時間有關。

And Cordstrom and I both solve that problem, right? I mean, we can get the cost down dramatically. We can provide a repeatable batch and so on. So I think that what Mark has done is exactly what the agencies want to see. They want to see a product that batch to batch consistently. It's the same. They know that, if Mark produces the batch today or produces it 10 years from now, it's not a different product. And then from an end user standpoint, an insurance standpoint and a payment standpoint, yes, these are ultra rare diseases, so the prices are high because the volume is low, but still, the margins are there. Typically cell therapies, oftentimes the margins are a little bit tight. We've seen some companies that have some approvals for some cell therapies and they charge very high pro.

我和科德斯特羅姆都能解決這個問題，對吧？我的意思是，我們可以大幅降低成本。我們可以提供可重複生產的批次等等。所以我認為馬克所做的正是各機構希望看到的。他們希望看到產品批次間的一致性。是一樣的。他們知道，無論是馬克今天生產這批產品，或是 10 年後生產這批產品，都不是不同的產品。從最終用戶、保險和支付的角度來看，是的，這些都是極其罕見的疾病，所以價格很高，因為數量很少，但利潤空間仍然存在。通常情況下，細胞療法的利潤空間都比較有限。我們看到一些公司獲得了某些細胞療法的批准，但他們的收費非常高。

Prices for it, but what they're making net is is a challenge, they've got a lot of work to streamline their manufacturing. Those are not things we have to worry too much about with courses because that's the way Mars has has built it. Truly kind of this process engineering mindset from the start, big advantage. So from regulatory standpoint, it's nice to see that they're approving products like this. We've, I like to think that Cordstrom is the most advanced Mizeymal stromal cell program out there, at least as far as I've seen, and I think it's designed with the regulators in mind from the very beginning.

雖然價格方面存在一些問題，但他們的淨利潤卻面臨挑戰，他們需要做很多工作來簡化生產流程。對於課程方面的問題，我們不必太擔心，因為火星就是這樣設計的。從一開始就採用這種流程工程思維方式，確實很有優勢。所以從監管角度來看，很高興看到他們批准了這樣的產品。我認為，Cordstrom 是目前最先進的 Mizeymal 基質細胞項目，至少就我所見而言是這樣，而且我認為它從一開始就考慮到了監管人員的需求。

Got it thank you guys for taking all the questions.

明白了，謝謝各位回答所有問題。

Appreciate it. You got a lot, Jason. Next question please.

謝謝。傑森，你得到了很多。下一個問題。

(Operator Instructions) James Molloy AGP / Alliance Global Partners Corp - Analyst

（操作說明）James Molloy AGP / Alliance Global Partners Corp - 分析師

Hey guys, Matt on for gym today. Thank you for taking our questions. First on Cordstrom, I wanted to ask about the treatment paradigm, the current treatment paradigm for REV in the UK and how that looks, and where Cordstrom might slot in there. I understand, Krystal Biotech's Vyjuvek is approved there but not Abeona's PDL.

大家好，今天由Matt來健身。感謝您回答我們的問題。首先，關於 Cordstrom，我想詢問一下治療模式，英國目前 REV 的治療模式及其現狀，以及 Cordstrom 可能在其中扮演的角色。據我了解，Krystal Biotech 的 Vyjuvek 在那裡獲得了批准，但 Abeona 的 PDL 沒有。

Yes, so it is approved. It's not approved by NICE for reimbursement through the NHS, so there is no RDE specific treatment available to be prescribed and paid for by the UK government for in our healthcare system, so it's only available for self-payers in the UK, and I'm not aware of it being widely used, if at all. Certainly the largest center for pediatric ADE in the UK is. 8 Ormond Street, where the trial was led from, and they are weakly calling me up and saying how can we open the next phase of the trial for the patients who were treated. So, there is a big demand for this, I think alluding to what David was saying, the challenge here with the therapies that are available in IDE is their price and their price point, and we have a drug here that can Come in well below those current price points and have a systemic effect.

是的，已經獲得批准。由於英國國家衛生與臨床優化研究所 (NICE) 未批准透過英國國家醫療服務體系 (NHS) 進行報銷，因此英國政府無法在我們的醫療保健系統中開立和支付針對 RDE 的特定治療方案，所以它只能供英國的自費患者使用，而且據我所知，它即使被廣泛使用，也並不常見。英國最大的兒科ADE中心無疑是…8 Ormond Street，也就是這項試驗的發起地，他們無力地打電話給我，問我如何才能為接受治療的患者啟動下一階段的試驗。所以，這方面的需求很大。我認為，正如大衛所說，目前IDE療法面臨的挑戰是價格和定價，而我們這裡有一種藥物，價格可以遠低於目前的定價，並且具有系統性作用。

So, we already have this trial was driven by NIHR. It was a publicly funded trial, and we were paid to supply the drug. We didn't run the trial, as I said, and that the NIHR, which is part of NHS England. Specifically said they wanted this drug to be developed as a commercial product if the trials were successful, so we have a lot of push in the UK to make this drug available to patients as soon as possible, and I don't see a problem in terms of competing drugs at the moment. What will happen in the US I'm uncertain because obviously those drugs are already licensed and are being used in the US, but it can come down to efficacy and cost at the end of the day in terms of which ones survive and which ones where costrom comes within that.

所以，我們已經知道這項試驗是由 NIHR 推動的。這是一項公共資金資助的試驗，我們受僱提供藥物。正如我所說，我們沒有進行試驗，而且 NIHR 是 NHS England 的一部分。他們明確表示，如果試驗成功，他們希望將這種藥物開發成商業產品，因此我們在英國大力推動盡快讓患者能夠用上這種藥物，而且就目前而言，我認為不存在藥物競爭方面的問題。我不確定美國會發生什麼，因為很明顯這些藥物已經獲得許可並在美國使用，但最終哪些藥物能存活下來，哪些藥物會因為成本問題而受到影響，這可能取決於療效和成本。

We, no, sorry to interrupt. I just want to add, if you don't mind, we cheer all, we cheer on all the competitor products. When you see this disease, it's a huge unmet need and these children, it's just heartbreaking to see. And and so, we cheer them on, but I think that the the one thing to really keep in mind is that it's typically looked at as a dermatologic disease from a topical nature, but the systemic systems overlooked. But a byproduct of all of the app, the 3 approved products in the United States is an increase in itch. If you look at the label, it'll say itch, and that's really part of the process of healing, right? So the more healing you have the itch. And again, if you're going to itch this cream off, you've got to cover it up, tremendously painful.

我們，不，不好意思打斷。我只想補充一點，如果您不介意的話，我們為所有競爭對手的產品歡呼。當你看到這種疾病時，你會發現這是一個巨大的未滿足的需求，看到這些孩子，真是令人心碎。所以，我們為他們加油，但我認為真正需要記住的一點是，它通常被視為一種局部性的皮膚病，而全身系統卻被忽視了。但所有這些應用程序，以及美國批准的 3 款產品，都帶來了副作用：搔癢加劇。如果你看一下標籤，上面會寫著“癢”，而這其實是癒合過程的一部分，對吧？所以，癒合得越快，癢感就越強烈。再說一遍，如果你要搔掉這個藥膏，就必須把它遮蓋起來，否則會非常痛。

And if you list the, if you look at the list of the top complaints from REVEB patients, usually number one is itch, even before pain. It's been described to us as like being bitten by a mosquito 1,000 times a day. It's just chronic itch, and so it's, it should slot nicely with the competitors. And again, keep in mind, we're conscious on the margins of the product from day zero before we even started the trial. Got it.

如果你列出 REVEB 患者的主要抱怨，你會發現排名第一的通常是搔癢，甚至排在疼痛之前。有人形容這種感覺就像一天被蚊子叮咬1000次。這只是慢性瘙癢，所以，它應該能很好地與競爭對手的產品相媲美。再次提醒大家，從一開始，甚至在開始試用之前，我們就非常關注產品的各個方面。知道了。

Thank you for the call. And in terms of data points suggesting Cordstrom has a systemic effect, I know you mentioned the cytokines, but do you have any anecdotal or quantitative, data suggesting symptomatic relief for patients in terms of systemic. Like wounds behind the eyelids and stuff like that.

謝謝你的來電。至於表明 Cordstrom 具有全身性影響的數據點，我知道您提到了細胞因子，但您是否有任何軼事或定量數據表明，就全身性而言，該藥物可以緩解患者的症狀？例如眼瞼後面的傷口之類的。

Yeah, so the data that are published from the trial by Great Ormond Street that were published a few months ago demonstrated the systemic effects that are associated with itch is a systemic disease effectively, but yes, there are systemic data reports from that. What we're looking at now are getting into those data much more acutely, and that's being done independently and blinded from us to guarantee that when we have the data to take to the agencies, there's no question that we have manipulated it, so we'll be getting those data, but I haven't seen them, so I'm unable to comment on them. But when they when they come through, we will be sharing them.

是的，幾個月前大奧蒙德街醫院公佈的試驗數據顯示，搔癢症是一種全身性疾病，其全身性影響確實存在，但確實有相關的全身性數據報告。我們現在正在更深入地研究這些數據，這項工作是獨立進行的，並且對我們保密，以確保當我們把數據提交給相關機構時，不會有人質疑我們篡改過數據。所以我們會收到這些數據，但我還沒有看到，所以我無法對此發表評論。但是，當它們最終成型時，我們會與大家分享。

Yeah, and I'll just add from an anecdotal standpoint it's a very good question that the patients on the trial could pretty much identify whether they're on drug or placebo, and one of the patients, unbeknownst to us ended up speaking to the BBC and the BBC published an article about it, and he talked about his massive improvement in quality of life, being able to do things he wasn't able to do before. And this is something that we heard from some of the PIs as well, and visually, they saw an improvement in the quality of life of these children and their wounds look different to them as well. But if you type in BBC and REB into Google, I think it's the first thing that pops up, but that is a child that describes his experience on the Mission EB trial from Cordstrom.

是的，我還要補充一點，從軼事的角度來看，這是一個很好的問題，試驗中的患者幾乎可以分辨出他們服用的是藥物還是安慰劑。其中一位患者，我們事先並不知情，最後接受了BBC的採訪，BBC也發表了一篇關於此事的文章。他在文章中談到了他的生活品質得到了極大的改善，能夠做一些以前做不到的事情。我們也從一些首席研究員那裡聽到了類似的說法，而且從視覺上看，他們發現這些孩子的生活品質有所改善，他們的傷口看起來也不同了。但是，如果你在谷歌上輸入 BBC 和 REB，我想第一個跳出來的就是這個，那是一個孩子描述了他在科德斯特羅姆參加“使命 EB”試驗的經歷。

Got it thank you. And then just lastly on cash runway, where does your current cash position get you out to in terms of milestones with Cordstrom and also with XPro as well?

明白了，謝謝。最後，關於現金儲備，您目前的現金狀況能夠讓您在 Cordstrom 和 XPro 的里程碑專案中達到什麼目標？

Yeah, so Q1's a big timing period for us for expo. We should have very clear clarity on an accelerated pathway and the phase 2 meeting, and certainly the imaging data by then. Our cache runway, as we've reported in the quarter, is really to the end of next year in Q4. And then obviously we've got, we're getting close to the MAA which will be around the middle of next year. On top of that, as Mark had alluded earlier, we'll have we should have some of the cytokine data and additional data around the Mission EB program towards the end of this year as well. So a number of milestones before we run out of cash.

是的，所以第一季對我們來說是展會的重要時期。到那時，我們應該對加速治療方案、第二階段會議以及影像數據有非常清楚的了解。正如我們在本季度報告中所述，我們的快取儲備實際上可以維持到明年第四季末。然後很明顯，我們即將迎來 MAA，它將在明年年中左右舉行。除此之外，正如馬克之前提到的那樣，我們應該會在今年年底前獲得一些細胞激素數據和有關Mission EB計劃的其他數據。所以，在我們資金耗盡之前，還有一系列里程碑要完成。

Understood thank you guys for taking our Questions

明白了，謝謝各位回答我們的問題。

Thank you.

謝謝。

Thank you. And this does conclude our Q&A session. I will now turn the call back to David for closing remarks.

謝謝。我們的問答環節到此結束。現在我將把電話轉回給大衛，請他作總結發言。

Appreciate it. I'd like to wrap up our prepared remarks by saying that we're as excited as ever about the future of a new bio. Despite the setbacks of missing the top-line on the Mindful trial, we're convinced in the prospects for expo in the Alzheimer's disease and in other diseases.

謝謝。我想在結束我們準備好的演講時說，我們對新生物技術的未來仍然充滿熱情。儘管在 Mindful 試驗中未能取得預期效果，但我們仍然堅信 Expo 在阿茲海默症和其他疾病領域的應用前景。

Meanwhile, we're very optimistic about filing an MAA and DLA in courts from next year, and we believe that platform has far greater potential than the market is giving it credit for. We've had a number of attainable goals in front of us, and we appreciate your support as we go about achieving achieving them. As always, we thank our stakeholders for your continued support and look forward to updating on our progress on the discussion milestones. Thank you Everybody.

同時，我們對明年向法院提交 MAA 和 DLA 申請非常樂觀，我們相信該平台的潛力遠遠超出市場對其的認知。我們面前有許多可以實現的目標，感謝你們在我們努力實現這些目標的過程中給予的支持。一如既往，我們感謝各位利害關係人的持續支持，並期待向大家報告我們在討論里程碑方面的進展。謝謝大家。

Thank you.

謝謝。

And this does conclude today's program. Thank you for your participation. You may disconnect at any time.

今天的節目到此結束。感謝您的參與。您可以隨時斷開連線。