Inhibikase Therapeutics Inc (IKT) 2024 Q1 法說會逐字稿

Greetings, and welcome to Inhibikase Therapeutics' first-quarter 2024 financial results conference call.

您好，歡迎參加 Inhibikase Therapeutics 2024 年第一季財務業績電話會議。

(Operator Instructions)

（操作員說明）

As a reminder, this conference is being recorded.

提醒一下，本次會議正在錄製中。

It is now my pleasure to introduce your host, Mr. Alexander Lobo, Stern Investor Relations.

現在我很高興向您介紹主持人，斯特恩投資者關係部的 Alexander Lobo 先生。

Thank you, Mr. Lobo, you may begin.

謝謝您，洛博先生，您可以開始了。

Good morning, and welcome to Inhibikase Therapeutics' first-quarter 2024 financial results conference call and audio webcast.

早安，歡迎來到 Inhibikase Therapeutics 的 2024 年第一季財務業績電話會議和音訊網路廣播。

With me today is Dr. Milton Werner, Chief Executive Officer; and Garth Lees-Rolfe, Chief Financial Officer.

今天與我在一起的是執行長 Milton Werner 博士；和財務長 Garth Lees-Rolfe。

On May 15, Inhibikase issued a press release announcing financial results for the first quarter ended March 31, 2024.

5 月 15 日，Inhibikase 發布新聞稿，宣布截至 2024 年 3 月 31 日的第一季財務表現。

We encourage everyone to read yesterday's press release as well as Inhibikase's quarterly report on Form 10-Q, which has been filed with the SEC.

我們鼓勵大家閱讀昨天的新聞稿以及 Inhibikase 已向 SEC 提交的 10-Q 表格季度報告。

The company's press release and Form 10-Q are also available on Inhibikase website at inhibikase.com. In addition, this conference call is being webcast through the Investor Relations section of the company's website and will be archived there for future reference.

該公司的新聞稿和表格 10-Q 也可在 Inhibikase 網站 inhibikase.com 上取得。此外，本次電話會議正在透過公司網站的投資者關係部分進行網路直播，並將存檔以供日後參考。

Please note that certain information discussed on today's call is covered under the Safe Harbor provisions of the Private Securities Litigation Reform Act of 1995.

請注意，今天電話會議中討論的某些資訊受 1995 年《私人證券訴訟改革法案》的安全港條款管轄。

Participants are cautioned that this conference call contains time-sensitive information that is accurate only as of the date of this live broadcast, May 16, 2024.

請與會者註意，本次電話會議包含時間敏感訊息，僅截至本次直播之日（2024 年 5 月 16 日）準確。

Actual results could differ materially from those stated or implied by these forward-looking statements due to risks and uncertainties associated with the company's business.

由於與公司業務相關的風險和不確定性，實際結果可能與這些前瞻性陳述中明示或暗示的結果有重大差異。

Information on potential risks and uncertainties are set forth in our most recent public filings with the SEC at sec.gov. The company undertakes no obligation to revise or update any forward-looking statements to reflect events or circumstances after the date of this webcast, except as may be required by applicable securities laws.

有關潛在風險和不確定性的資訊已在我們最近向 SEC 提交的 sec.gov 公開文件中列出。本公司不承擔修改或更新任何前瞻性聲明以反映本網路廣播日期之後發生的事件或情況的義務，除非適用的證券法可能要求。

With that said, I would now like to turn the call over to Dr. Milton Werner.

話雖如此，我現在想將電話轉給米爾頓·維爾納博士。

Milton, you may begin.

米爾頓，你可以開始了。

Thank you, Alex, and thank you, everyone, for joining us today to review our first-quarter 2024 financial results and recent clinical and business updates. 2024 is shaping up to be a year of clinical and regulatory execution as we advance our core programs towards important inflection points.

謝謝 Alex，也謝謝大家今天加入我們，回顧我們 2024 年第一季的財務表現以及最近的臨床和業務更新。 2024 年將成為臨床和監管執行的一年，我們將核心計畫推向重要的轉折點。

And we are proud of the achievements already accomplished by our team in the first quarter.

我們為我們的團隊在第一季的成就感到自豪。

We are making rapid progress in the enrollment of our Phase 2 trial for risvodetinib or risvo in Parkinson's disease, and we anticipate enrolling the final patient in June with top-line data reported in the second half of the year.

我們正在快速招募 risvodetinib 或 risvo 治療帕金森氏症的 2 期試驗，我們預計將在 6 月招募最後一名患者，並在下半年報告頂線數據。

On the regulatory front, we had positive interactions with two FDA divisions for imatinib program, IkT-001Pro, as we continue to position this asset for the potential opportunity in pulmonary arterial hypertension and pursue the existing opportunity in blood and stomach cancers.

在監管方面，我們與 FDA 的兩個部門就伊馬替尼計畫 IkT-001Pro 進行了積極的互動，我們繼續將這項資產定位於肺動脈高壓的潛在機會，並尋求血液和胃癌的現有機會。

So let's take a deeper dive into each of our programs, beginning with risvodetinib.

因此，讓我們從 risvodetinib 開始更深入地了解我們的每個項目。

Risvo is a potent selective inhibitor of c-Abl that is administered once daily that we believe may slow or halt the progression of Parkinson's disease.

Risvo 是一種有效的選擇性 c-Abl 抑制劑，每天給藥一次，我們相信它可以減緩或阻止帕金森氏症的進展。

Our 201 trial is a two-phase trial with an ongoing 12-week double-blind study across three doses we believe should achieve therapeutic effect plus placebo.

我們的 201 試驗是一項兩階段試驗，正在進行為期 12 週的雙盲研究，涉及三種劑量，我們認為加安慰劑應該能達到治療效果。

The trial is approximately 83% enrolled as of May 10, with 99 participants, 15 prospective participants in medical screening, 22 potential participants being evaluated for suitability to initiate medical screening.

截至 5 月 10 日，該試驗入組人數約為 83%，共有 99 名參與者，其中 15 名潛在參與者正在接受醫學篩檢，22 名潛在參與者正在接受評估是否適合啟動醫學篩檢。

Additionally, 44 participants have completed the full 12-week dosing period.

此外，44 名參與者已完成完整的 12 週給藥期。

To date, there have been 25 mild and three moderate adverse events observed that might be related to risvo treatment.

迄今為止，已觀察到 25 起輕度不良事件和 3 起中度不良事件可能與 risvo 治療有關。

Four people withdrew from the trial without completing 12 weeks.

4 人未完成 12 週就退出試驗。

As I mentioned earlier, we anticipate that the last patient will be enrolled in June, and we expect to report top-line results from the study in the second half of this year.

正如我之前提到的，我們預計最後一名患者將於 6 月入組，並預計在今年下半年報告研究的主要結果。

Following completion of the 12-week double-blind period, we expect to request an end of Phase 2 meeting with the FDA.

12 週雙盲期結束後，我們預計將請求結束與 FDA 的第二階段會議。

Overall, we remain impressed by the speed at which our trial has been enrolling patients, as well as the broader interest expressed in the Parkinson's community nationwide.

總的來說，我們的試驗招募患者的速度以及全國帕金森氏症社區表達的更廣泛的興趣仍然給我們留下了深刻的印象。

We've worked hard to make sure that our dedicated patient portal -- accessible at www.the201trial.com -- provides accurate and up-to-date information regarding our trial and how to get involved and believe that the portal has been instrumental in enabling us to effectively enroll participants across all 32 open clinical trial sites.

我們努力確保我們的專用患者門戶網站（可透過 www.the201Trial.com 訪問）提供有關我們的試驗以及如何參與的準確和最新信息，並相信該門戶網站在以下方面發揮了重要作用：使我們能夠在所有32 個開放臨床試驗中心有效招募參與者。

As we continue to work to find the capital necessary to initiate two one-year extension trial, we are encouraged by what is emerging on the biomarker front.

當我們繼續努力尋找啟動兩項為期一年的延期試驗所需的資金時，我們對生物標誌物前緣出現的情況感到鼓舞。

Recently, we disclosed the development of a novel antibody against the key marker of alpha-synuclein pathology in Parkinson's disease, namely an antibody that can recognize phosphorylated tyrosine 39.

最近，我們公開了針對帕金森氏症α-突觸核蛋白病理學關鍵標記物的新型抗體的開發，即能夠識別磷酸化酪胺酸39的抗體。

We believe this antibody will serve a dual purpose of allowing us to track alpha-synuclein pathology and its possible elimination, along with a measure of target engagement by risvo.

我們相信這種抗體將具有雙重目的，即讓我們能夠追蹤 α-突觸核蛋白病理學及其可能的消除，以及衡量 risvo 的目標參與程度。

The development of this antibody prompted our recent grant submissions to the National Institute of Neurological Disease and Stroke (sic - "National Institute of Neurological Disorders and Stroke") or NINDS, which is an institute of the National Institutes of Health or NIH.

這種抗體的開發促使我們最近向國家神經疾病和中風研究所（原文如此，「國家神經疾病和中風研究所」）或 NINDS（美國國立衛生研究院或 NIH 的一個研究所）提交了資助申請。

This antibody would be incorporated into both the skin biopsy tests and scene application tests that are already being used in the 201 trial to track the effect of risvo on the underlying pathology of disease in both the central and peripheral nervous systems.

該抗體將被納入 201 試驗中已使用的皮膚活檢測試和場景應用測試中，以追蹤 risvo 對中樞和周圍神經系統疾病的潛在病理學的影響。

Moving now to IkT-001Pro, our pro-drug formulation of imatinib mesylate that has been designed to potentially improve on the safety and tolerability profile of imatinib.

現在轉向 IkT-001Pro，這是我們甲磺酸伊馬替尼的前藥製劑，旨在潛在地改善伊馬替尼的安全性和耐受性。

We continue to make significant strides in the advancement of the pro-drug through our ongoing discussions with the FDA.

透過與 FDA 的持續討論，我們在前藥的發展方面繼續取得重大進展。

On January 19, we held the pre-NDA meeting with the FDA to discuss the requirements for potential approval under the 505(b)(2) statute.

1 月 19 日，我們與 FDA 舉行了 NDA 前會議，討論 505(b)(2) 法規下潛在批准的要求。

We were pleased with the discussion we had with the agency as we begin the process of building our first NDA package.

當我們開始建立第一個 NDA 包的過程時，我們對與該機構進行的討論感到滿意。

Our discussion with the FDA provided a roadmap to NDA submission to include our agreement to conduct a pre-clinical test to evaluate how 001Pro and imatinib affects certain gut transporters and to consider evaluating the 1,200 milligram dose of 001Pro as a possible equivalent to the approved dose of 800 milligram of imatinib mesylate.

我們與FDA 的討論為NDA 提交提供了路線圖，其中包括我們同意進行臨床前測試，以評估001Pro 和伊馬替尼如何影響某些腸道轉運蛋白，並考慮評估1,200 毫克劑量的001Pro 作為可能與核准劑量相當的劑量800毫克甲磺酸伊馬替尼。

Notably, we are able to pursue approval on all alone indications for which imatinib mesylate is approved.

值得注意的是，我們能夠對甲磺酸伊馬替尼已獲批准的所有單獨適應症尋求批准。

As we have continued to evaluate how to maximize value for 001Pro, we have also explored non-ecology indications for which 001Pro could prove to be effective.

在我們繼續評估如何最大化 001Pro 價值的同時，我們也探索了 001Pro 可能被證明有效的非生態適應症。

To this end, on April 5, we held a pre-IND meeting with the Office of Cardiology, Hematology, Endocrinology, and Nephrology in the Division of Cardiology and Nephrology at the FDA.

為此，4 月 5 日，我們與 FDA 心臟病學和腎臟科的心臟病學、血液學、內分泌學和腎臟科辦公室舉行了 IND 前會議。

We were discussing the potential of 001Pro as a disease-modifying treatment for pulmonary arterial hypertension or PAH.

我們正在討論 001Pro 作為肺動脈高壓或 PAH 疾病緩解治療的潛力。

Pulmonary arterial hypertension is a rare disease of the pulmonary microvasculature that primarily affects women between the ages of 30 to 60.

肺動脈高壓是一種罕見的肺微血管疾病，主要影響 30 至 60 歲的女性。

There are approximately 30,000 cases of PAH in the US alone.

光在美國就有大約 30,000 例 PAH 病例。

And many treatments for PAH are aimed at addressing symptoms of disease rather than outright curing it.

許多多環芳烴治療方法旨在解決疾病症狀，而不是徹底治癒疾病。

The global PAH market size is valued at approximately $7.66 billion, and we believe that IKT-001Pro would have the potential to deliver imatinib with an improved safety and tolerability profile that imatinib mesylate itself, an improved safety and tolerability profile, relative to imatinib mesylate itself for this indication.

全球PAH市場規模估值約76.6億美元，我們相信IKT-001Pro將有潛力提供伊馬替尼，其安全性和耐受性比甲磺酸伊馬替尼本身​​更高，相對於甲磺酸伊馬替尼本身​​，安全性和耐受性得到改善對於這個指示。

Although we have yet to conduct any clinical studies to evaluate 001Pro and PAH, our pre-IND meeting has served to review our proposed light-stage trial design to confirm the new molecular entity status for 001Pro and PAH, and to open the door to exclusivity designations where 001Pro to be approved for this indication.

儘管我們尚未進行任何臨床研究來評估 001Pro 和 PAH，但我們的 IND 前會議已審查了我們提出的輕階段試驗設計，以確認 001Pro 和 PAH 的新分子實體狀態，並打開排他性之門其中001Pro 已獲核准用於該適應症。

These outcomes provide the opportunity to unlock substantial value for 001Pro as an indication of high unmet need that was not anticipated when 001Pro was first conceived.

這些結果為釋放 001Pro 的巨大價值提供了機會，表明存在大量未滿足的需求，而這在 001Pro 首次構思時並未預料到。

I will now turn the conversation over to our Chief Financial Officer, Garth Lees-Rolfe, to review our financial results for the quarter.

我現在將對話轉給我們的財務長 Garth Lees-Rolfe，以審查我們本季的財務表現。

Garth?

加斯？

Thank you, Milton.

謝謝你，米爾頓。

Now, let me review our financial results for the year and quarter ended March 31, 2024.

現在，讓我回顧一下截至 2024 年 3 月 31 日的年度和季度的財務表現。

Net loss for the quarter ended March 31, 2024, was $4.6 million, or $0.73 per share, compared to a net loss of $4.5 million, or $0.98 per share for the quarter ended March 31, 2023.

截至 2024 年 3 月 31 日的季度淨虧損為 460 萬美元，即每股 0.73 美元，而截至 2023 年 3 月 31 日的季度淨虧損為 450 萬美元，即每股 0.98 美元。

Research and development expenses for the quarter ended March 31, 2024, were $2.8 million, compared to $2.9 million for the same period in 2023.

截至 2024 年 3 月 31 日的季度研發費用為 280 萬美元，而 2023 年同期為 290 萬美元。

The $0.1 million decrease was to a decrease of $0.7 million in IkT-001Pro expenses offset by a $0.6 million increase in risvodetinib expenses.

減少 10 萬美元是指 IkT-001Pro 費用減少 70 萬美元，被 risvodetinib 費用增加 60 萬美元所抵銷。

Selling, general, and administrative expenses for the quarter ended March 31, 2024, were $2 million, compared to $1.9 million for the same period in 2023.

截至 2024 年 3 月 31 日的季度的銷售、一般和管理費用為 200 萬美元，而 2023 年同期為 190 萬美元。

The $0.1 million increase was primarily due to a $0.18 million increase in legal and consulting fees and a $0.8 million net decrease in all other general and administrative expenses.

增加 10 萬美元主要是由於法律和諮詢費用增加 18 萬美元，以及所有其他一般和管理費用淨減少 80 萬美元。

As of March 31, 2024, we had $9.7 million in cash and cash equivalents and marketable securities.

截至 2024 年 3 月 31 日，我們擁有 970 萬美元的現金和現金等價物以及有價證券。

We expect that the existing cash and cash equivalents will be sufficient to fund operations through November 2024.

我們預計現有現金和現金等價物將足以為 2024 年 11 月之前的營運提供資金。

That concludes our review of financial statements.

我們對財務報表的審查到此結束。

I'd like to hand the call back over to Milton for closing remarks.

我想將電話轉回米爾頓做總結發言。

Thank you, Garth.

謝謝你，加斯。

I'd like to now open the call to questions.

我現在想開始提問。

Operator?

操作員？

(Operator Instructions)

（操作員說明）

Ed White, HC Wainwright.

懷特 (Ed White)，HC 溫賴特 (HC Wainwright)。

Thanks for taking my questions.

感謝您回答我的問題。

I just have one on risvo and one on 001Pro.

我只有一台 risvo 和一台 001Pro。

So on risvo, how you would be looking at the data?

那麼在 risvo 上，您將如何查看數據？

What, to you, will be a positive result?

對您來說，什麼會是正面的結果？

And then assuming a positive result, what is your next steps on your pathway to approval?

然後假設取得了積極的結果，您在獲得批准的道路上的下一步是什麼？

So for us, it's a two-fold question.

所以對我們來說，這是一個雙重問題。

We are sitting at the forefront of biomarker developments and those biomarker measurements are ongoing.

我們處於生物標誌物開發的最前沿，而這些生物標誌物測量正在進行中。

And we believe they will illustrate, hopefully, under treatment only, but we don't know what we're going to see yet, that we're able to impact both central nervous system and peripheral nervous system pools of alpha-synuclein aggregate.

我們相信，它們將有望說明，僅在治療下，但我們還不知道我們將看到什麼，即我們能夠影響中樞神經系統和周圍神經系統的 α-突觸核蛋白聚集體。

As we've defined what the pathological aggregate of alpha-synuclein is, namely, that it's phosphorylated at Ser129 and tyrosine 39, our ability to track that species and watch whether treatment results in any changes in the pools of that species will allow us to have a direct measure of an impact of a drug treatment on underlying pathology of disease.

正如我們已經定義了α-突觸核蛋白的病理聚集體是什麼，即它在Ser129 和酪氨酸39 處磷酸化，我們追蹤該物種並觀察治療是否會導致該物種庫發生任何變化的能力將使我們能夠直接衡量藥物治療對疾病潛在病理學的影響。

There has been no prior measurement of that kind, and we think that the biomarker results will be quite illustrative.

之前沒有進行過此類測量，我們認為生物標記結果將非常具有說明性。

Secondary to that, we're only treating for 12 weeks.

其次，我們只治療 12 週。

No one expects to see some remarkable reversal of Parkinson's disease in such a short period of time.

沒有人期望在如此短的時間內看到帕金森氏症的顯著逆轉。

But we would expect to see some impact on quality of life measures, on Parkinson's disease severity, and/or on formal measurements of parts one, two, or three, or any combination thereof of what is known as the UPDRS, Universal Parkinson's Disease Rating Score.

但我們預計會對生活品質測量、帕金森氏症嚴重程度和/或第一部分、第二部分或第三部分或其任何組合的正式測量產生一些影響，即所謂的 UPDRS（通用帕金森氏症評級）分數。

And I think we've said this many times in the past, in press releases, and discussions of this kind, we might begin to see trends in the right direction without worsening relative to placebo.

我認為我們過去已經多次說過，在新聞稿和此類討論中，我們可能會開始看到趨勢朝著正確的方向發展，而不會相對於安慰劑惡化。

And if that's what we see, coupled with biomarkers, that will be, in our view, a pretty remarkable outcome and that will motivate what we're doing in Phase 3.

如果這就是我們所看到的，再加上生物標誌物，我們認為這將是一個非常了不起的結果，這將激勵我們在第三階段所做的事情。

We hope to be able to have the capital to run the 12-month extension study so we can keep measuring these patients.

我們希望能夠有資金進行為期 12 個月的擴展研究，以便我們能夠繼續對這些患者進行測量。

But we don't have the capital just yet, so we don't know what's going to happen there.

但我們還沒有資金，所以我們不知道那裡會發生什麼事。

Okay, thanks, Milton.

好的，謝謝，米爾頓。

And just on 001Pro, congratulations on getting it viewed as a novel chemical entity for PAH.

就在 001Pro 上，恭喜您將其視為 PAH 的新型化學實體。

Just wanted to get your thoughts what the protocol would look like for the Phase 2, 3 potential trial design?

只是想了解您對第 2 期、第 3 期潛在試驗設計的方案有何看法？

So there's a pretty standard way to do this.

所以有一個非常標準的方法來做到這一點。

So first of all, to us, what's remarkable about this is that we had this idea to try to address tolerability issues in the design of Abl inhibitors for non-ecology purposes.

首先，對我們來說，值得注意的是，我們的想法是嘗試解決非生態目的 Abl 抑制劑設計中的耐受性問題。

And our first accomplishment was trying to mask some of the potential GI causes in this class of medication.

我們的第一個成就是試圖掩蓋此類藥物中一些潛在的胃腸道原因。

We were able to measure bioequivalence.

我們能夠測量生物等效性。

And all of that work was paid for by the National Cancer Institute through an SBIR grant.

所有這些工作均由國家癌症研究所透過 SBIR 撥款支付。

Once we recognize that pro-drugs seems to have, well, we believe, some favorable properties, but certainly not fully proven to be superior or better tolerated yet.

一旦我們認識到前藥似乎具有一些有利的特性，我們相信，但肯定還沒有完全證明其優越性或更好的耐受性。

We haven't done enough patients.

我們治療的病人還不夠多。

We recognize that the old work that was done in the early 2010s that could allow us to think again whether imatinib is a suitable agent for PAH; we're not alone in this.

我們認識到 2010 年代初期所做的舊工作可以讓我們重新思考伊馬替尼是否是治療 PAH 的合適藥物；我們並不孤單。

Two other companies have pursued such ideas.

另外兩家公司也追求過這樣的想法。

And but they have not been able to do it with systemic administration of imatinib, which we think is the only way to properly inhibit the Abl enzymes necessary to cause an effect in disease.

但他們還無法透過全身施用伊馬替尼來做到這一點，我們認為這是正確抑制對疾病產生影響所必需的 Abl 酶的唯一方法。

And so that trial design would use a Phase 2 period with a smaller cohort.

因此，試驗設計將使用具有較小隊列的第二階段。

That trial design would have a primary end point in pulmonary vascular resistance, which is a pretty typical design.

此試驗設計的主要終點是肺血管阻力，這是一個非常典型的設計。

I believe the trial size of design now is 140 patients.

我相信現在設計的試驗規模是140名患者。

And we would look to roll those patients if the safety profile emerging early in that trial, because you're measuring it over 24 weeks, if that safety profile looks favorable, we'll amend the protocol to incorporate the entire Phase 3 program so people will roll smoothly from Phase 2 into Phase 3.

如果安全性在該試驗早期出現，我們會考慮滾動這些患者，因為你要在 24 週內進行測量，如果安全性看起來不錯，我們將修改方案以納入整個 3 期計劃，以便人們將從第二階段順利推進到第三階段。

The Phase 3 programs, just like the Phase 2 programs in this indication, are pretty standard.

第三階段計劃，就像該適應症中的第二階段計劃一樣，都是相當標準的。

You have to measure hemodynamics, things like pulmonary vascular resistance, a secondary end point in the Phase 3.

你必須測量血流動力學，例如肺血管阻力，這是第三階段的次要終點。

Your primary endpoint has to be six minute walking distance.

您的主要終點必須是六分鐘的步行距離。

A success in six-minute walking distance is typically viewed as better than 30-meter improvement.

六分鐘步行距離的成功通常被視為比 30 公尺的進步更好。

And so that's what we'd be looking for.

這就是我們要尋找的。

The nice thing about 001Pro, it's a very unique opportunity for us is that we already know imatinib is a highly effective agent, almost as effective or perhaps even superior to WINREVAIR, which was just approved for Merck, which operates by different mechanism using the same approach.

001Pro 的好處是，這對我們來說是一個非常獨特的機會，因為我們已經知道伊馬替尼是一種高效藥物，幾乎與WINREVAIR 一樣有效，甚至可能優於WINREVAIR，WINREVAIR 剛剛被默克批准，後者透過不同的機制使用相同的藥物來發揮作用。

And so and we think that sotatercept or WINREVAIR and imatinib are complementary; they work at either ends of the disease-causing mechanism.

因此，我們認為 sotatercept 或 WINREVAIR 和伊馬替尼是互補的；它們在致病機制的兩端發揮作用。

And so one could imagine a combination of therapies, which would be quite compatible in our view, where you can really lead to a real corrective therapy for people.

因此，人們可以想像一種療法的組合，在我們看來，這將是非常相容的，你可以真正為人們帶來真正的糾正療法。

And there are no other agents out there that are like this, just imatinib and sotatercept to date.

到目前為止，還沒有其他類似的藥物，只有伊馬替尼和索塔西普。

And so we think this is a fantastic opportunity in a hard-to-treat patient population.

因此，我們認為這對於難以治療的患者群體來說是一個絕佳的機會。

And it's so rare to have an asset where you already know how to dose it; you already have a whole portfolio of safety data going over two decades in a variety of different types of patients.

擁有一項你已經知道如何配置的資產是非常罕見的。您已經擁有二十多年來各種不同類型病患的完整安全資料組合。

You know something is going to work.

你知道有些事情會起作用。

And now you have to just reevaluate the safety and tolerability profile in the target population as your primary outcome that you need to accomplish.

現在您必須重新評估目標族群的安全性和耐受性概況，作為您需要實現的主要結果。

Because everything else is in line for approval for imatinib in this indication, as long as the older safety data that was observed is not observed in the new treatment paradigm for these patients.

因為伊馬替尼在該適應症中的其他一切都符合批准，只要在這些患者的新治療模式中沒有觀察到舊的安全性數據即可。

So we're quite excited about this.

所以我們對此感到非常興奮。

Okay, that's great.

好的，太好了。

Thanks, Milton.

謝謝，米爾頓。

And just you had mentioned partnering before and just wondering if there's any update on potential partnering of this drug?

您之前曾提到過合作，只是想知道這種藥物的潛在合作是否有任何更新？

We're actively seeking that.

我們正在積極尋求這一點。

The players are pretty obvious, and we are in discussions with more than one of them.

參與者非常明顯，我們正在與不只一位參與者進行討論。

And I think that's all I could say at the present time; it's an early stage.

我想這就是我目前能說的全部；現在還處於早期階段。

We needed to see these regulatory milestones achieved with relation to how the FDA would view imatinib delivered as pro drug without accomplishment in hand and seeing that we have the kind of product lifecycle, at least potentially available to us, as a novel chemical entity with patent and pneumolecularity exclusivity available, potentially accelerated approval aspects available because it's a novel mechanism of action for this indication.

我們需要看到這些監管里程碑的實現，涉及FDA 如何看待伊馬替尼作為前體藥物交付，但尚未取得成果，並看到我們擁有這樣的產品生命週期，至少是我們可能使用的，作為一種擁有專利的新型化學實體和肺分子排他性可用，潛在的加速批准方面可用，因為它是該適應症的一種新穎的作用機制。

Now that that's all under our belt, we have a much stronger case to make with potential partners to either license the drug or to collaborate and help fund or predominantly fund the trial work.

現在這一切都在我們的掌控之中，我們有一個更有力的理由與潛在合作夥伴合作，要么許可該藥物，要么合作並幫助資助或主要資助試驗工作。

This is not trivial trial work.

這不是一項微不足道的試驗工作。

And once you put patients on drugs in this indication, you can never take them off.

一旦你讓患者服用這種適應症的藥物，你就永遠無法停止用藥。

Nobody will participate if you're going to withdraw medication at the end of the trial.

如果您要在試驗結束時撤藥，沒有人會參與。

So you have to roll everybody into an extension trial or keep them into the next phase of the trial of clinical development program until you get to approval or it fails to be approved.

因此，你必須讓每個人都參加延期試驗，或讓他們進入臨床開發計畫的下一階段試驗，直到獲得批准或未能獲得批准。

So the commitment you make is very significant, very fast, and that really requires a partner for a company of our size.

因此，您所做的承諾非常重要、非常迅速，這確實需要一個適合我們規模公司的合作夥伴。

Okay.

好的。

Thanks, Milton, for taking my questions.

謝謝米爾頓回答我的問題。

You're welcome.

不客氣。

Thank you.

謝謝。

Ladies and gentlemen, we have reached the end of question-and-answer session.

女士們、先生們，問答環節已經結束。

I would now like to turn the floor over to Dr. Milton Werner for closing comments.

現在我想請 Milton Werner 博士發表總結意見。

Well, thank you very much for your attention today.

嗯，非常感謝您今天的關注。

Our shareholders have seen a lot of volatility around our stock price.

我們的股東看到我們的股價波動很大。

They continue to see our progress in all of our programs and the novel ways which help drive to develop value for our assets and for shareholder return.

他們繼續看到我們在所有計劃中取得的進展以及有助於推動我們的資產價值和股東回報發展的新穎方法。

And we really want to thank the shareholders, along with all of the trial participants whose commitment has been unparalleled.

我們真的要感謝股東以及所有付出了無與倫比的努力的試驗參與者。

For reasons that we cannot explain, our trial participants really want to be involved in the trial work they're participating in and they're providing invaluable information towards understanding risvodetinib could be a transformative therapy in neurodegenerative disease.

由於我們無法解釋的原因，我們的試驗參與者確實希望參與他們正在參與的試驗工作，並且他們為了解 risvodetinib 可能成為神經退化性疾病的變革性療法提供了寶貴的資訊。

And so I want to thank you for all of your attention through this process.

因此，我要感謝大家在過程中的關注。

Thank you.

謝謝。

This concludes today's teleconference.

今天的電話會議到此結束。

You may 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。