Moleculin Biotech Inc (MBRX) 2024 Q2 法說會逐字稿

Greetings and welcome to the conference call where Moleculin Biotech discusses plans for MIRACLE Phase 3 pivotal trial.

您好，歡迎參加 Moleculin Biotech 討論 MIRACLE 3 期關鍵試驗計畫的電話會議。

(Operator Instructions) As a reminder, this conference is being recorded.

（操作員指示）謹此提醒，本次會議正在錄製中。

It is now my pleasure to introduce your host, Jenene Thomas.

現在我很高興向大家介紹你們的主持人 Jenene Thomas。

Thank you, operator.

謝謝你，接線生。

At this time, I'd like to remind our listeners that remarks made during this webcast may state management's intentions, beliefs, expectations, or future projections.

此時，我想提醒我們的聽眾，在本次網路廣播中發表的言論可能表明管理層的意圖、信念、期望或未來預測。

These are forward-looking statements and involve risks and uncertainties.

這些均為前瞻性陳述，涉及風險和不確定性。

Forward-looking statements on this call are made pursuant to the Safe Harbor provisions of the federal securities laws and are based on Moleculin's current expectations, and actual results could differ materially.

本次電話會議的前瞻性聲明是根據聯邦證券法的安全港條款做出的，並且基於 Moleculin 目前的預期，實際結果可能存在重大差異。

As a result, you should not place undue reliance on any forward-looking statements.

因此，您不應過度依賴任何前瞻性陳述。

Some of the factors that could cause actual results to differ materially from these contemplated by such forward-looking statements are discussed in the periodic reports Moleculin files with the Securities and Exchange Commission.

Moleculin 向美國證券交易委員會提交的定期報告中討論了一些可能導致實際結果與此類前瞻性陳述預期結果有重大差異的因素。

These documents are available in the Investors section of the company's website and on the Securities and Exchange Commission's website.

這些文件可在公司網站的投資者部分和美國證券交易委員會的網站上找到。

We encourage you to review these documents carefully.

我們鼓勵您仔細查看這些文件。

Additionally, certain information contained in this webcast relates to, or is based on, studies, publications, surveys, and other data obtained from third-party sources and the company's own estimates and research.

此外，本網路廣播中包含的某些資訊涉及或基於從第三方來源獲得的研究、出版物、調查和其他數據以及公司自己的估計和研究。

While the company believes these third-party sources to be reliable as of the date of this presentation, it has not independently verified, and makes no representation as to the adequacy, fairness, accuracy, or completeness of, or that any independent source has verified, any information obtained from third-party sources.

儘管該公司認為截至本簡報發布之日這些第三方來源是可靠的，但它尚未進行獨立驗證，也沒有就其充分性、公平性、準確性或完整性發表任何聲明，也沒有任何獨立來源已驗證，從第三方來源獲得的任何資訊。

So joining us on today's webcast from Moleculin's leadership team are Walter Klemp, Chairman and Chief Executive Officer; and Dr. John Paul Waymack, Senior Chief Medical Officer.

因此，與我們一起參加今天 Moleculin 領導團隊網絡廣播的包括董事長兼首席執行官 Walter Klemp；和高級首席醫療官 John Paul Waymack 博士。

The team is also joined by Dr. Michael Andreeff, Professor of Medicine, Department of Leukemia, Division of Cancer Medicine, The University of Texas, MD Anderson Cancer Center.

德州大學 MD 安德森癌症中心癌症醫學部白血病科醫學教授 Michael Andreeff 博士也加入了團隊。

I would now like to turn the webcast over to Walter Klemp, Chairman and CEO.

我現在想將網路廣播轉交給董事長兼執行長 Walter Klemp。

Walter, please proceed.

沃特，請繼續。

Thank you, Jenene, and welcome, everyone.

謝謝你，珍妮，歡迎大家。

This is a major update call for Moleculin.

這是 Moleculin 的重大更新。

We'll be updating you on our plan moving forward after the encouraging feedback from our recent meeting with the FDA.

在最近與 FDA 的會議獲得令人鼓舞的反饋後，我們將向您通報我們的最新計劃。

So we're really glad to have you joining us today.

我們非常高興您今天加入我們。

Since this is a clinical update, we won't be covering any financial information on this webcast and we'll just be focusing on making sure investors understand the significance of our recent announcement of moving into a Phase 3 pivotal trial.

由於這是臨床更新，我們不會在此網路廣播中涵蓋任何財務信息，我們將專注於確保投資者了解我們最近宣布進入第三階段關鍵試驗的重要性。

Now, before we get into the meat of this important update, let me give a brief review of what Annamycin is and why it's so important, especially in acute myeloid leukemia, or AML.

現在，在我們深入了解這項重要更新的實質內容之前，讓我先簡單回顧一下安黴素是什麼以及它為何如此重要，尤其是在急性骨髓性白血病 (AML) 中。

The most important class of drugs to date for AML, as well as many other tumors, is anthracyclines.

迄今為止，治療 AML 以及許多其他腫瘤最重要的一類藥物是蒽環類藥物。

In fact, anthracyclines have been a cornerstone of cancer treatment for over 50 years now.

事實上，50 多年來，蒽環類藥物一直是癌症治療的基石。

But there's been very little in terms of the advancement of anthracyclines except for some improvements in drug delivery.

但除了藥物傳遞方面的一些改進外，蒽環類藥物的進步很少。

Until now, there really hasn't been a successful effort to actually improve the efficacy and safety of anthracyclines with true breakthroughs in chemical structure.

到目前為止，還沒有真正在化學結構上取得真正突破來提高蒽環類藥物的功效和安全性的成功努力。

But Annamycin changes all this.

但安黴素改變了這一切。

We're talking about the first real breakthrough in 50 years.

我們正在談論 50 年來第一個真正的突破。

Moleculin's proprietary anthracycline is an entirely new chemical entity and we believe it's a true disruptor to this well-established class of drugs.

Moleculin 的專有蒽環類藥物是一種全新的化學實體，我們相信它是這個成熟藥物類別的真正顛覆者。

Based on our clinical trials to date, we believe it may be safer and more effective than any currently approved anthracycline, period.

根據我們迄今為止的臨床試驗，我們相信它可能比目前批准的任何蒽環類藥物更安全、更有效。

And we believe it fills an unmet need for more than half of the AML population and has uses far beyond AML.

我們相信它滿足了一半以上 AML 人群未滿足的需求，並且其用途遠遠超出了 AML。

Even though today's discussion is about AML, don't forget we have an active clinical trial in sarcoma as well.

儘管今天的討論是關於 AML，但不要忘記我們在肉瘤方面也有一項活躍的臨床試驗。

And we believe that the most important immediate commercial opportunity for Annamycin is that it fills an unmet need for more than half of all AML patients.

我們相信，安黴素最重要的直接商業機會是它滿足了一半以上 AML 患者未滿足的需求。

And based on our clinical trials to date, Annamycin has delivered more than double the complete remission rate of any treatment for relapsed or refractory AML.

根據我們迄今為止的臨床試驗，安黴素的完全緩解率是任何復發或難治性 AML 治療方法的兩倍以上。

The leukemia community is grateful for the important contributions of existing anthracyclines as well as venetoclax and more recently targeted therapies.

白血病界感謝現有蒽環類藥物以及維奈托克和最近的標靶治療的重要貢獻。

But the sad truth is that all of these drugs combined help only about 40% of the AML population.

但令人悲傷的事實是，所有這些藥物加起來只能幫助大約 40% 的 AML 族群。

Per industry guidelines, including the NCCN, the rest, nearly 60% of AML patients are left to clinical trials or palliative care, and the primary reason for this is relapse from, or resistance to, the existing therapies.

根據包括 NCCN 在內的行業指南，近 60% 的 AML 患者需要進行臨床試驗或安寧療護，其主要原因是現有療法的復發或抗藥性。

And this is where Annamycin's lack of cross resistance comes into play and it shows in what we believe are the remarkable efficacy numbers that we've delivered to date.

這就是安黴素缺乏交叉抗藥性發揮作用的地方，我們相信迄今為止我們已經取得了顯著的療效數據。

For the most part, folks who have been following Moleculin have already seen these remarkable efficacy numbers, especially in second line subjects.

在大多數情況下，一直關注 Moleculin 的人們已經看到了這些顯著的療效數據，尤其是在二線受試者中。

But since our last update, we've added two more subjects.

但自從上次更新以來，我們又增加了兩個主題。

They aren't second line, so they didn't change the second line outcome.

他們不是二線，所以他們沒有改變二線的結果。

But what did change is to add another third line subject.

但改變的是增加了另一個第三行主題。

And we're now showing the combined results for second and third line subjects where the n equals 40 and the CRc rate is 50%.

我們現在顯示二線和三線受試者的綜合結果，其中 n 等於 40，CRc 率為 50%。

What's also changed is our median durability of remission, which has increased now to seven months.

同樣改變的是我們的緩解持續時間中位數，現在已增加到七個月。

And we've been able to characterize anecdotally that these outcomes appear to be agnostic to prior therapy, and importantly, have resulted in MRD negative test results in 78% of responders.

據我們所知，這些結果似乎與先前的治療無關，而且重要的是，78% 的應答者的 MRD 檢測結果為陰性。

Now, MRD stands for measurable residual disease, and it's gained in popularity among investigators as a strong prognostic indicator.

現在，MRD 代表可測量的殘留疾病，作為強有力的預後指標，它在研究人員中越來越受歡迎。

Simply put, the prevailing opinion is that MRD negative patients are more likely to have long-term positive outcomes than those who test MRD positive.

簡而言之，普遍的觀點是 MRD 陰性患者比 MRD 檢測呈陽性的患者更有可能獲得長期陽性結果。

And compared to available treatments for relapsed or refractory AML, 78% MRD negative is an impressive outcome.

與復發性或難治性 AML 的現有治療方法相比，78% 的 MRD 陰性結果令人印象深刻。

We've also gained insight supporting our belief that Annamycin is genotype and mutation agnostic.

我們也獲得了支持我們信念的見解，即安黴素與基因型和突變無關。

In fact, 89% of our complete remissions came from subjects with cytogenetics and mutations that are generally considered difficult to treat and are associated with poor outcomes.

事實上，89% 的完全緩解來自具有細胞遺傳學和突變的受試者，這些細胞遺傳學和突變通常被認為難以治療且與不良預後相關。

So we've taken some of the most severe AML patients and given the majority of them the most hoped for outcome, durable, complete remission, and for many, a pathway to a curative bone marrow transplant.

因此，我們收治了一些最嚴重的AML 患者，並為他們中的大多數人提供了最希望的結果，即持久、完全緩解，並且對許多人來說，提供了一條通往治癒性骨髓移植的途徑。

And that brings us to why we're here today, the launch of our Phase 3 pivotal trial.

這就是我們今天在這裡的原因：啟動我們的第三階段關鍵試驗。

Officially, we're calling it the Moleculin Relapsed Refractory AML AnnAraC Clinical Evaluation, and that's quite a mouthful.

我們正式稱之為分子復發難治性 AML AnnAraC 臨床評估，這有點拗口。

So we've also coined the acronym, MIRACLE.

所以我們也創造了縮寫「MIRACLE」。

In order to present the MIRACLE trial in more detail, let me ask our Senior Chief Medical Officer, Dr. Paul Waymack, to walk you through our recent FDA meeting and the resulting pivotal trial design.

為了更詳細地介紹 MIRACLE 試驗，讓我請我們的高級首席醫療官 Paul Waymack 博士向您介紹我們最近的 FDA 會議以及由此產生的關鍵試驗設計。

And I'll warn you in advance, Dr. Waymack is recovering from a bout of COVID, so his voice is a little challenged today.

我會提前警告您，韋馬克博士正在從新冠病毒感染中恢復，所以他的聲音今天有點困難。

Paul?

保羅？

Thanks, Wally.

謝謝，沃利。

Overall, we strongly believe that our recent end of Phase 1B/2 meeting with the FDA significantly de-risked the development program for Annamycin.

總體而言，我們堅信，最近與 FDA 舉行的 1B/2 期會議大大降低了安黴素開發計劃的風險。

Importantly, we presented the FDA with data from 84 patients, including reports by an independent cardiology expert in the field of cardiac damage from anthracyclines.

重要的是，我們向 FDA 提交了 84 名患者的數據，包括蒽環類藥物心臟損傷領域獨立心臟科專家的報告。

And by the way, those reports indicated a complete lack of cardiotoxicity from Annamycin.

順便說一句，這些報告顯示安黴素完全沒有心臟毒性。

These data and reports were reviewed by both the FDA Hematology Oncology Division and their Cardiorenal Division, which is considered the ultimate authority within FDA regarding the cardiotoxicity of drugs seeking approval.

這些數據和報告均經過 FDA 血液腫瘤科及其心腎科的審查，該科被認為是 FDA 內關於尋求批准的藥物心臟毒性的最終權威。

As a result of this review, the FDA has now agreed to allow AML patients in the US to be treated for the first time above the current lifetime maximum allowable anthracycline dose.

作為此審查的結果，FDA 現已同意允許美國 AML 患者首次接受高於目前終生最大允許蒽環類藥物劑量的治療。

And that opens the door for us to finally bring Annamycin back to the US for all future clinical development, which reduces the time and complexity of ultimately gaining marketing approval.

這為我們最終將安黴素帶回美國進行所有未來的臨床開發打開了大門，這減少了最終獲得行銷批准的時間和複雜性。

And as we have disclosed already, the performance of Annamycin in the MB-106 trial has been described by KOL as remarkable.

正如我們已經揭露的，安黴素在 MB-106 試驗中的表現被 KOL 描述為「卓越」。

But this success has created a bit of a challenge, and that FDA has a new initiative called Project Optimus, which is designed to encourage developers to avoid higher than necessary dosing.

但這項成功也帶來了一些挑戰，FDA 推出了一項名為 Project Optimus 的新舉措，旨在鼓勵開發人員避免高於必要的劑量。

You see, historically, many oncology drugs have been labeled to be administered at their maximum tolerable dose, or MTD, with those regards to whether a lesser dose could be just as effective.

您會看到，從歷史上看，許多腫瘤藥物都被標記為以最大耐受劑量（MTD）給藥，考慮到較小的劑量是否也能同樣有效。

In aligning with this new initiative, this is why in the dose escalation phase of our MB-106 trial, we stopped sort of establishing an MTD, and instead, focused on what was clearly a safe and effective dose at 230 milligrams per meter square.

為了配合這項新舉措，這就是為什麼在我們的 MB-106 試驗的劑量遞增階段，我們停止了建立 MTD，而是專注於每平方公尺 230 毫克的明顯安全有效劑量。

However, as a further step in establishing the optimum dose, the FDA would like our pivotal Phase 3 trial to incorporate a comparison between a lower dose, in this case 190 milligrams per meter square, and the 230 milligrams per meter square used in the expansion phase of MB-106.

然而，作為確定最佳劑量的進一步步驟，FDA 希望我們的關鍵 3 期試驗納入較低劑量（本例中為每平方米 190 毫克）與擴展中使用的每平方米 230 毫克之間的比較MB- 106 相。

In order to accomplish this, and as a specific recommendation of the FDA, we are planning the MIRACLE trial to be an adaptive Phase 3 trial design whereby the first 75 patients will be randomized to receive HiDAC plus either placebo, 190 milligrams per meter square of Annamycin, or 230 milligrams per meter square of Annamycin.

為了實現這一目標，並且作為 FDA 的具體建議，我們計劃將 MIRACLE 試驗設為適應性 3 期試驗設計，其中前 75 名患者將被隨機接受 HiDAC 加上安慰劑，每平方米 190 毫克安黴素，或每平方公尺230毫克安黴素。

For the second portion of the trial, approximately 120 patients will be randomized to receive HiDAC plus either placebo, or whichever dose of Annamycin is found to be optimal based upon the interim look at the data from the first 75 patients.

對於試驗的第二部分，大約 120 名患者將被隨機分配接受 HiDAC 加安慰劑，或根據對前 75 名患者數據的中期觀察發現最佳劑量的安黴素。

The selection of an optimum dose will be based not only on the absence of dose-limiting toxicities, but also on the overall balance of safety, pharmacokinetics, and efficacy data obtained from the initial 75 patients is consistent with FDA's new Project Optimus initiative.

最佳劑量的選擇不僅基於不存在劑量限制性毒性，而且還基於從最初 75 名患者獲得的安全性、藥物動力學和療效數據的整體平衡，這與 FDA 的新 Project Optimus 計劃一致。

Of critical importance here, however, the primary endpoint is planned to be complete remission at approximately one month.

然而，這裡至關重要的是，主要終點計劃是在大約一個月內完全緩解。

This is especially important because of the speed with which we can evaluate performance and the fact that, based on our data today, we have a very high degree of confidence in the ability of Annamycin to outperform the comparator arm, high-dose Ara-C using that endpoint.

這一點尤其重要，因為我們可以快速評估性能，而且根據我們今天的數據，我們對安黴素優於比較組高劑量 Ara-C 的能力非常有信心使用該端點。

The secondary endpoints of durability and remission are also important, but they won't be the basis for approval, and therefore, this trial design significantly shortens our potential path to approval.

耐久性和緩解的次要終點也很重要，但它們不會成為批准的基礎，因此，該試驗設計顯著縮短了我們的潛在批准路徑。

It is important to note that the FDA does not distinguish between second, third, and further lines of therapy in the NDA process and has requested that we also provide randomized data for third line as well as second line subjects.

值得注意的是，FDA 在 NDA 過程中不區分二線、三線和進一步的治療，並要求我們也提供三線和二線受試者的隨機數據。

To accommodate this request while also facilitating the expedient establishment of an optimal dose, we plan to conduct the MIRACLE trial in only second line subjects and then follow on with a similar trial that we're calling MIRACLE2, enrolling only third line subjects.

為了滿足這項要求，同時也便於方便地確定最佳劑量，我們計劃僅在二線受試者中進行 MIRACLE 試驗，然後繼續進行類似的試驗，我們稱之為 MIRACLE2，僅招募三線受試者。

We estimate this to be approximately a 200 subject trial, randomizing 1:1 between the optimum dose of Annamycin established in the MIRACLE trial versus placebo, both combined with high-dose Ara-C.

我們估計這將是一項大約有200 名受試者的試驗，在MIRACLE 試驗中確定的安黴素最佳劑量與安慰劑之間按1:1 隨機分配，兩者均與高劑量Ara-C聯合使用。

One thing we cannot stress enough is how much we believe this trial design has de-risked our path to approval.

我們必須強調的一件事是，我們多麼相信這種試驗設計已經降低了我們獲得批准的風險。

As you can see from this chart, the historical performance of HiDAC is very well established at around 17% to 18%.

從這張圖表中可以看出，HiDAC 的歷史表現非常穩定，約 17% 至 18%。

In comparison, Annamycin's performance in combination with HiDAC in our most recent trial was more than -- double that level.

相較之下，在我們最近的試驗中，安黴素與 HiDAC 組合的性能是該水平的兩倍多。

Dr. Andreeff, you've treated many AML patients in your career and you were in attendance during our meeting with the FDA.

Andreeff 博士，您在您的職業生涯中治療過許多 AML 患者，並且您出席了我們與 FDA 的會議。

What are your thoughts about Annamycin's prospects for approval?

您對安黴素的核准前景有何看法？

Well, Paul, I agree with you.

好吧，保羅，我同意你的觀點。

This was a very successful meeting with the FDA.

這是與 FDA 的一次非常成功的會議。

And of course, it helps when the Phase 2 trial data are as strong as they are for Annamycin.

當然，當第二階段試驗數據與安黴素一樣強大時，這會有所幫助。

As for the trial design, it's always a challenge to create a robust, randomized trial when there are so many different off-label approaches being tried by different institutions for this group of patients.

至於試驗設計，當不同機構針對這群患者嘗試瞭如此多不同的標籤外方法時，創建穩健的隨機試驗始終是一個挑戰。

But I think the FDA really helped us when they agreed to allow patients to cross over after 30 days.

但我認為當 FDA 同意允許患者在 30 天後跨越時，他們確實幫助了我們。

That should really help with recruitment since the patients won't be taking a big risk by being randomized into the control group only.

這確實有助於招募，因為患者不會因為僅被隨機分配到對照組而冒很大的風險。

Overall, I'm very optimistic about this trial for Annamycin.

總的來說，我對安黴素的這次試驗非常樂觀。

As your chart shows, the performance of high dose Ara-C as a control arm is well understood.

如圖表所示，高劑量 Ara-C 作為對照組的表現是眾所周知的。

And you see MB-106 trial data are indicative.

您會看到 MB-106 試驗數據具有指示性。

Annamycin should have no problems prevailing in this Phase 3 trial.

安黴素在本次 3 期試驗中應該不會有任何問題。

Well, thank you, Paul and Michael, for helping everyone understand the significance of our move into Phase 3 development.

好吧，謝謝 Paul 和 Michael，幫助大家理解我們進入第三階段開發的重要性。

So here's how we believe this all plays out in our estimated timeline.

因此，我們相信這一切都會在我們的預計時間表中實現。

We should be able to begin enrolling in the MIRACLE trial in the first quarter of 2025.

我們應該能夠在 2025 年第一季開始參加 MIRACLE 試驗。

And we would expect to have the unblinded interim data for the first 75 patients available by the middle of 2026.

我們預計到 2026 年中期可以獲得前 75 名患者的非盲中期數據。

That's when we would pause, as Paul mentioned, to review with the FDA and select the optimum dose.

正如 Paul 所提到的，那時我們會停下來與 FDA 進行審查並選擇最佳劑量。

That's also when we should be able to apply for breakthrough designation, which will be a solid indicator of whether the FDA views Annamycin to be a significant opportunity for patients and a high priority for potential approval.

那時我們也應該能夠申請突破性指定，這將成為 FDA 是否認為安黴素對患者來說是一個重要機會以及潛在批准的高度優先事項的可靠指標。

Now, throughout this phase of our development, you can see that we expect multiple high-value milestones to support interest and trading activity in the company's stock.

現在，在我們發展的這個階段，您可以看到我們期望實現多個高價值里程碑來支持公司股票的興趣和交易活動。

One such additional milestone would be a recruitment progress report that we plan to give once we've recruited the first 40 or so subjects.

其中一個額外的里程碑是招募進度報告，我們計劃在招募了前 40 名左右的受試者後提供該報告。

Call it a midway point on our way to unblinded data.

我們可以稱之為非盲資料之路的中間點。

Now, although that recruitment update will be blinded, we will be able to announce the total number of CRs at that point.

現在，儘管招募更新將是盲目的，但我們屆時將能夠公佈 CR 的總數。

And here's why that's so important.

這就是為什麼這麼重要。

If, say, at the point where we have 40 subjects treated, we see 11 or 12 CRs, mathematically, it's likely we're beating the control because the historical performance of our control HiDAC is known and has been consistent from trial to trial.

比方說，如果我們有40 名受試者接受治療，我們看到11 或12 個CR，從數學上講，我們很可能擊敗了對照，因為我們的對照HiDAC 的歷史表現是已知的，並且每次試驗都是一致的。

So that should give us even more confidence about the unblinded data in 2026.

因此，這應該會讓我們對 2026 年的非盲數據更有信心。

Now, the completion of enrollment and beginning of the NDA process wouldn't be until 2028, but we can't overstate the importance of having unblinded interim data on 75 subjects in mid-'26.

現在，註冊工作的完成和 NDA 流程的開始要到 2028 年，但我們不能誇大在 26 年中期獲得 75 名受試者的非盲中期數據的重要性。

That should add confidence that the final results of the MIRACLE trial will end positively.

這應該會增加人們對 MIRACLE 試驗最終結果將取得正面結果的信心。

In our view, this interim data in mid-'26 will probably be the most critical inflection point next to actually submitting our NDA.

我們認為，26 年中期的中期數據可能是繼實際提交 NDA 之後最關鍵的轉折點。

And as we've said before, we are now entering a period where these milestones will very likely stimulate partnering activity that could lead to the kind of valuation and exit opportunities that our shareholders deserve.

正如我們之前所說，我們現在正進入一個時期，這些里程碑很可能會刺激合作活動，從而帶來股東應得的估值和退出機會。

At this point, I would also like to remind folks just how much better we believe Annamycin is compared with the best alternative approved treatments available for relapsed or refractory AML.

在這一點上，我還想提醒人們，我們相信安黴素與可用於治療復發或難治性 AML 的最佳替代療法相比要好得多。

All of the targeted therapies combined are able to help only about 13% of second line AML patients in the aggregate.

所有標靶治療總共只能幫助約 13% 的二線 AML 患者。

The performance we produced in the MB-106 trial suggests that Annamycin should be able to more than double that success rate.

我們在 MB-106 試驗中的表現顯示安黴素應該能夠使成功率增加一倍以上。

And even though today's discussion is solely focused on AML, please don't forget that Annamycin has potential uses far beyond just this one indication.

儘管今天的討論僅集中於 AML，但請不要忘記安黴素的潛在用途遠遠超出了這種適應症。

Based on our current sarcoma clinical trial and pre-clinical studies and other indications, we believe that Annamycin could play a significant role in the treatment of all the cancers listed here, just as other currently approved anthracyclines do today.

根據我們目前的肉瘤臨床試驗和臨床前研究以及其他適應症，我們相信安黴素可以在治療此處列出的所有癌症中發揮重要作用，就像目前其他已批准的蒽環類藥物一樣。

Importantly though, our data indicate that Annamycin should be safer and maybe more effective than those other anthracyclines.

但重要的是，我們的數據顯示安黴素應該比其他蒽環類藥物更安全，而且可能更有效。

And when you translate all of this into market value, the potential for shareholders here, we believe is enormous.

當你將所有這些轉化為市場價值時，我們相信股東的潛力是巨大的。

Just two of the drugs from that previous slide, Idhifa and Tibsovo, now those are targeted AML drugs relevant to just a small subset of the AML population and with an average CR rate of around 20%.

上一張幻燈片中只有兩種藥物，Idhifa 和 Tibsovo，現在它們是靶向 AML 藥物，僅與一小部分 AML 人群相關，平均 CR 率約為 20%。

Those two drugs sold to Servier in 2021 for $2 billion.

這兩種藥物於 2021 年以 20 億美元的價格出售給施維雅。

We believe that Annamycin is relevant to three times as many AML patients and has demonstrated more than double the performance for those treated.

我們相信安黴素與三倍的 AML 患者有關，並且對治療患者的療效提高了一倍以上。

And as we've said many times recently, we believe the disparity in value that's reflected on this slide cannot last.

正如我們最近多次說過的那樣，我們相信這張投影片上反映的價值差異不會持續下去。

And the ultimate exit value for Moleculin shareholders may be measured in the billions.

Moleculin 股東的最終退出價值可能達到數十億美元。

Thankfully, we now have the regulatory visibility that we've needed to give people a realistic timeline for this to happen.

值得慶幸的是，我們現在擁有了所需的監管可見性，可以為人們提供實現這一目標的現實時間表。

Just to be clear for investors, we've included in this presentation a table of upcoming milestones.

為了讓投資者清楚，我們在本簡報中列出了即將到來的里程碑的表格。

And as always, this presentation will be available on our website for your review.

與往常一樣，該簡報將在我們的網站上供您審閱。

Becoming a Phase 3 company has been such a sought-after goal for us.

成為第三階段的公司一直是我們追求的目標。

It's hard to believe that we're actually here.

很難相信我們真的在這裡。

We believe the valuation disparity that has persisted to date can no longer be justified.

我們認為迄今為止持續存在的估值差異不再合理。

Most importantly, we believe we are on the cusp of improving and even saving thousands of lives by positioning Annamycin for new drug approval.

最重要的是，我們相信，透過安黴素獲得新藥批准，我們即將改善甚至拯救數千人的生命。

To all of those who have helped us get to this point, we thank you.

對於所有幫助我們走到這一步的人，我們表示感謝。

And to everyone following Moleculin, we are so pleased to be able to say, this is finally happening.

對於所有關注 Moleculin 的人，我們很高興能夠說，這終於發生了。

Thanks, everyone, and have a great day.

謝謝大家，祝你有美好的一天。

This concludes today's conference.

今天的會議到此結束。

You may now disconnect your lines at this time.

此時您可以斷開線路。

Thank you for your participation.

感謝您的參與。