DiaMedica Therapeutics Inc (DMAC) 2020 Q4 法說會逐字稿

Good morning, ladies and gentlemen, and welcome to the DiaMedica Therapeutics Fourth Quarter 2020 Conference Call. An audio recording of the webcast will be available shortly after the call today on DiaMedica's website at www.diamedica.com in the Investor Relations section.

早安，女士們、先生們，歡迎參加 DiaMedica Therapeutics 2020 年第四季電話會議。今天電話會議後不久，將在 DiaMedica 網站 www.diamedica.com 的投資者關係部分提供網路廣播的錄音。

Before the company proceeds with its remarks, please note that the company will be making forward-looking statements on today's call. These statements are subject to risks and uncertainties that could cause actual results to differ materially from those projected in these statements. More information, including factors that could cause actual results to differ from projected results appears in the including factors that could cause actual results. Cautionary statement note regarding forward-looking statements in the company's press release issued yesterday and under the heading Risk Factors in DiaMedica's most recent annual report from Form 10-K. DiaMedica's SEC filings are available at www.sec.com and on its website. Again, that's www.sec.gov. Please also note that any comments made on today's call speak only as of today, March 11, 2021, and may no longer to be accurate at the time of any replay or transcript reading DiaMedica disclaims any duty to update its forward-looking statements. Following the prepared remarks, we will open the phone lines for questions.

在該公司發表評論之前，請注意該公司將在今天的電話會議上發表前瞻性聲明。這些陳述存在風險和不確定性，可能導致實際結果與這些陳述中的預測有重大差異。更多資訊（包括可能導致實際結果與預測結果不同的因素）出現在可能導致實際結果的因素中。關於該公司昨天發布的新聞稿中以及 DiaMedica 最新 10-K 表格年度報告中“風險因素”標題下的前瞻性陳述的警示性聲明。 DiaMedica 的 SEC 備案文件可在 www.sec.com 及其網站上查閱。再說一遍，這是 www.sec.gov。另請注意，對今天電話會議發表的任何評論僅代表今天（2021 年 3 月 11 日），在重播或閱讀文字記錄時可能不再準確。DiaMedica 不承擔更新其前瞻性陳述的任何義務。在準備好發言後，我們將開通電話提問。

I would now like to introduce your host for today's call, Rick Pauls, DiaMedica's President and Chief Executive Officer. Mr. Pauls, you may begin.

現在我想介紹一下今天電話會議的主持人，DiaMedica 總裁兼執行長 Rick Pauls。保羅斯先生，您可以開始了。

Thank you, operator. Good morning, everyone. We hope you are all well and we'd like to welcome you to the year-end 2020 earnings and business update call. We issued a press release with a business update and summary of our financial results for 2020 yesterday after the markets closed. At that time, we also filed our annual reports on Form 10-K. Both documents can be found in the Investor Relations section of our website at diamedica.com.

謝謝你，接線生。大家，早安。我們希望您一切順利，歡迎您參加 2020 年年底收益和業務更新電話會議。昨天市場收盤後，我們發布了一份新聞稿，其中包含 2020 年業務更新和財務業績摘要。當時，我們也以 10-K 表格形式提交了年度報告。這兩份文件均可在我們網站 diamedica.com 的投資者關係部分找到。

I'm joined this morning by our Chief Financial Officer Scott Kellen; and our Chief Medical Officer, Dr. Harry Alcorn.

今天早上我們的財務長 Scott Kellen 也加入了我的行列。以及我們的首席醫療官 Harry Alcorn 博士。

Let me begin this morning with a few comments on our acute ischemic stroke program. As you recall, we were very pleased with the FDA accepted our request for a pre-IND meeting for our stroke development program and are encouraged by their written responses to our questions. Their responses indicated acceptance of key elements of our planned Phase II/III trial for DM199 in acute ischemic stroke patients. Specifically, we proposed an adaptive trial design, which will allow us to conduct an interim check. The interim check will evaluate the performance of DM199. Specifically, an independent data monitoring committee will evaluate whether DM199 is having a positive effect that is consistent with our statistical analysis plan assumptions and allow for an adjustment in the patient size, if necessary. In short, we believe that the guidance received from the FDA provides a clear path forward for our stroke program.

讓我從今天早上開始對我們的急性缺血性中風計劃發表一些評論。您還記得，我們​​很高興 FDA 接受了我們為中風發展計劃召開 IND 前會議的請求，並為他們對我們問題的書面答复感到鼓舞。他們的回應顯示接受我們計劃的急性缺血性中風患者的 DM199 II/III 期試驗的關鍵要素。具體來說，我們提出了一種適應性試驗設計，這將使我們能夠進行中期檢查。中期檢查將評估 DM199 的性能。具體來說，一個獨立的數據監測委員會將評估 DM199 是否具有與我們的統計分析計劃假設一致的積極作用，並在必要時允許調整患者規模。簡而言之，我們相信 FDA 的指導為我們的卒中計劃提供了明確的前進道路。

We are currently finalizing the Investigational New Drug Application for our proposed Phase II/III study and expect to be submitting this application later this month. In parallel with this process, we are taking steps to organize the supporting vendors to run the study. We still anticipate initiating the enrollment in the study later this summer. The results of our ReMEDy Phase II study in acute ischemic stroke will be the subject of an oral presentation at the upcoming International Stroke Conference 2021, being held virtually on March 17th to 19th, 2021.

我們目前正在敲定我們擬議的 II/III 期研究的研究性新藥申請，預計將於本月晚些時候提交該申請。同時，我們正在採取措施組織支持供應商進行這項研究。我們仍然預計在今年夏天晚些時候啟動這項研究的招募。我們針對急性缺血性中風的 ReMEDy II 期研究結果將成為即將於 2021 年 3 月 17 日至 19 日虛擬舉行的 2021 年國際中風會議上口頭報告的主題。

As we announced, we are also very pleased to be hosting a Stroke Key Opinion Leader Webinar on the Treatment of Acute Ischemic Stroke on March 19th at noon Eastern Time. The webinar will feature presentations from Dr. Scott Kasner of the University of Pennsylvania; and Dr. Paolo Madeddu of the University of Bristol, who will discuss the current treatment landscape and unmet medical need in the treating patients with acute ischemic stroke, along with our mechanism rationale in clinical data on stroke and recurrent stroke.

正如我們所宣布的，我們也很高興於東部時間 3 月 19 日中午舉辦關於急性缺血性中風治療的中風關鍵意見領袖網路研討會。該網路研討會將由賓州大學的 Scott Kasner 博士進行演講；布里斯託大學的 Paolo Madeddu 博士將討論治療急性缺血性中風患者的當前治療前景和未滿足的醫療需求，以及我們在中風和復發性中風臨床數據中的機制原理。

One final related note, I'd like to point out that on the DM199 for our stroke program, as it relates to reducing stroke reoccurrence. In November 2020, AstraZeneca received an approval for an expansion of its label for Brilinta, its latest generation blood thinner product. They were approved with an indication for reducing stroke reoccurrence in patients having had a mild stroke. We view AstraZeneca's label expansion as potentially opening another door for approval for DM199 in the treatment of stroke reoccurrence.

最後一個相關說明，我想指出的是，關於我們中風計畫的 DM199，因為它與減少中風復發有關。 2020 年 11 月，阿斯特捷利康獲得批准擴大其最新一代血液稀釋劑產品 Brilinta 的標籤。它們被批准用於減少輕度中風患者的中風復發。我們認為阿斯特捷利康的標籤擴展可能為 DM199 治療中風復發的批准打開另一扇大門。

If you recall from our ReMEDy Phase II data, we observed a statistically significant reduction in recurrent severe strokes. This was an 86% reduction, where there was 1 patient in the DM199 group compared with 7 in the placebo. And also to note that 4 of those 7 reoccurrence in the placebo were fatal. These results were study-wide, and we believe signaled the potential of DM199 to both improve the physical recoveries and reduced stroke reoccurrence. Stroke reoccurrence tends to be the more disabling, fatal and costly. We believe that DM199 has the potential to further improve the health and quality of life for stroke victims.

如果您還記得我們的 ReMEDy II 期數據，我們觀察到復發性嚴重中風的統計顯著減少。 DM199 組有 1 名患者，而安慰劑組有 7 名患者，減少了 86%。也要注意的是，安慰劑組中 7 次復發中有 4 次是致命的。這些結果是在整個研究範圍內進行的，我們相信這表明 DM199 具有改善身體恢復和減少中風復發的潛力。中風復發往往會造成更嚴重的殘疾、致命和昂貴的費用。我們相信 DM199 有潛力進一步改善中風患者的健康和生活品質。

Let us next update you on our REDUX trial studying DM199 as a treatment for 3 different causes of chronic kidney disease, or CKD. REDUX is a Phase II study in 13 centers with a target enrollment of 90 participants in 3 cohorts of 30 patients. Cohorts include IgA nephropathy, diabetic kidney disease, or DKD, and hypertensive African Americans.

接下來讓我們向您介紹我們的 REDUX 試驗的最新情況，該試驗研究 DM199 作為治療 3 種不同原因的慢性腎病 (CKD) 的方法。 REDUX 是一項在 13 個中心進行的 II 期研究，目標招募 3 個隊列（每組 30 名患者）中的 90 名參與者。隊列包括 IgA 腎病、糖尿病腎病變 (DKD) 和高血壓非裔美國人。

Participants in the REDUX CKD study will receive DM199 for approximately 13 weeks at 2 dose levels. The primary efficacy endpoint for the overall study are improvements in albinuria and eGFR.

REDUX CKD 研究的參與者將接受 2 個劑量等級的 DM199，為期約 13 週。整個研究的主要療效終點是白蛋白尿和 eGFR 的改善。

Secondary endpoints include evaluating the potential for DM199 to positive impact each of the underlying causes of CKD. Overall, our enrollment has reached 68 participants in the REDUX study. This includes the full enrollment in the DKD cohort. Enrollment in our IgA nephropathy cohort has reached 70%, or 21 participants, and enrollment in the African-American cohort remains at 50% or 15 participants. Obviously, we're very pleased to see the rapid enrollment in the DKD cohort. This was largely due to the size of the DKD population that matches the enrollment criteria for DKD, making it far easier to recruit the 30 participants despite concerns related to COVID. Also recall that the last participant was enrolled in this cohort in mid-December, and we are still very much on track to provide preliminary top line results from this cohort during the second quarter of 2021.

次要終點包括評估 DM199 對 CKD 的每個根本原因產生正面影響的潛力。整體而言，我們 REDUX 研究的報名人數已達 68 名。這包括 DKD 隊列的全部註冊。我們的 IgA 腎病隊列的入組率已達到 70%，即 21 名參與者，非裔美國人隊列的入組率仍維持在 50%，即 15 名參與者。顯然，我們很高興看到 DKD 隊列的快速註冊。這主要是由於 DKD 族群的規模符合 DKD 的招募標準，因此儘管存在與新冠病毒相關的擔憂，但招募 30 名參與者要容易得多。另請記住，最後一位參與者是在 12 月中旬加入該隊列的，我們仍有望在 2021 年第二季度提供該隊列的初步頂線結果。

With respect to the IgA nephropathy in African Americans, where enrollment has continued at a much slower-than-expected pace, we are pleased to report that we are seeing signs of increased activity. With the significant declines in new COVID cases and recently availability of vaccines, we now can announce that we anticipate completion of both of these cohorts in the second half of 2021.

關於非裔美國人的 IgA 腎病，其入組速度仍遠低於預期，我們很高興地報告，我們看到增加活動的跡象。隨著新冠肺炎新增病例的顯著下降以及最近疫苗的供應，我們現在可以宣布，預計這兩個隊列將在 2021 年下半年完成。

I would now like to ask Scott Kellen to take us through the financial results for 2020.

現在我想請 Scott Kellen 向我們介紹 2020 年的財務表現。

Thank you, Rick. Good morning, everyone. As Rick mentioned, we did release our full year 2020 financial results and filed our 10-K yesterday afternoon. If you haven't had a chance to review these documents, they are both available on either the DiaMedica or SEC websites.

謝謝你，瑞克。大家，早安。正如 Rick 所提到的，我們確實發布了 2020 年全年財務業績，並於昨天下午提交了 10-K 報表。如果您還沒有機會查看這些文件，您可以在 DiaMedica 或 SEC 網站上找到它們。

Our net loss for the full year of 2020 was $12.3 million or $0.78 per share. This compares to a net loss of $10.6 million or $0.89 per share for the prior year. Our research and development expenses were $8.3 million for the year ended December 31, 2020, and this compares to $7.9 million for the year ended December 31, 2019, an increase of $0.4 million.

我們 2020 年全年的淨虧損為 1,230 萬美元，即每股 0.78 美元。相比之下，上一年的淨虧損為 1,060 萬美元，即每股虧損 0.89 美元。截至2020年12月31日止年度，我們的研發費用為830萬美元，而截至2019年12月31日止年度的研發費用為790萬美元，增加了40萬美元。

Now, the increase was primarily due to a combination of costs incurred for our REDUX Phase II CKD study, which initiated in late 2019 and, of course, driven in particular by the addition of the third cohort, targeting the DKD patients, which fully enrolled during the fourth quarter of 2020.

現在，這一增長主要是由於我們的REDUX II 期CKD ​​研究產生的綜合成本，該研究於2019 年底啟動，當然，特別是由於第三個隊列的增加，該隊列針對DKD 患者，該隊列已完全入組2020 年第四季。

We also incurred increased noncash share-based compensation costs, and these costs were partially offset by decreases related to clinical study costs incurred for our ReMEDy stroke study, which wound down in the first half of 2020 and the nonrecurring costs of the Phase Ib CKD study, which was started and completed during 2019. Additionally, there was a year-over-year net decrease in drug manufacturing and development costs.

我們還增加了非現金股份補償成本，這些成本被 ReMEDy 中風研究（該研究於 2020 年上半年結束）相關的臨床研究成本減少以及 Ib 期 CKD 研究的非經常性成本部分抵消。 ，該項目於2019年啟動並完成。此外，藥品生產和開發成本比去年同期淨下降。

Our general and administrative expenses were $4.4 million and $3.7 million for the years ended December 31, 2020, and 2019, respectively. This $0.7 million increase was primarily due to increased noncash share-based compensation costs, increased outside professional services and increased directors' and officers' liability insurance. And the increase in 2020 was partially offset by reduced travel and meeting costs driven by restrictions instituted as countermeasures to the COVID-19 pandemic.

截至2020年12月31日及2019年12月31日止年度，我們的一般及管理費用分別為440萬美元及370萬美元。 70 萬美元的成長主要是由於非現金股份補償成本的增加、外部專業服務的增加以及董事和高級管理人員責任保險的增加。 2020 年的成長被為應對 COVID-19 大流行而採取的限制措施導致的旅行和會議成本減少所部分抵消。

Our total other income net was $0.4 million for the year ended December 31, 2020. This compares to $1 million for all of 2019. This decrease was driven primarily by the reduced [R&C] incentives receivable from the Australian government, which are paid for qualifying research work performed by our Australian subsidiary during 2020. And this, of course, was related to the wind-down of the ReMEDy study during the first half of 2020. This decrease was partially offset by increased foreign currency transaction gains recognized during 2020.

截至2020 年12 月31 日的年度，我們的其他淨收入總額為40 萬美元。相比之下，2019 年全年為100 萬美元。這一下降主要是由於應從澳大利亞政府收到的[R&C ] 激勵措施減少，這些激勵措施是為符合資格而支付的我們的澳洲子公司在2020 年開展的研究工作。當然，這與2020 年上半年ReMEDy 研究的結束有關。這一下降被2020 年確認的外幣交易收益增加部分抵銷。

Turning to the balance sheet. We finished the fourth quarter of 2020 with cash, cash equivalents and marketable securities of $27.5 million. Current liabilities were $2 million and working capital was $25.9 million. This compares to $7.9 million in cash, cash equivalents and marketable securities, $1.3 million in current liabilities and $7.5 million in working capital as of the end of 2019. The increases in the company's combined cash and marketable securities and in our working capital are due to our February and August 2020 public offerings of common shares. And if you recall, in August, we completed an underwritten public offering, raising gross proceeds of $23 million or net proceeds of $21.2 million. And in February, we completed an offering raising gross proceeds of $8.5 million or net proceeds of $7.7 million.

轉向資產負債表。截至 2020 年第四季度，我們的現金、現金等價物及有價證券為 2,750 萬美元。流動負債為 200 萬美元，營運資金為 2,590 萬美元。相較之下，截至 2019 年底，現金、現金等價物和有價證券為 790 萬美元，流動負債為 130 萬美元，營運資本為 750 萬美元。公司現金和有價證券合併以及營運資本的增加是由於我們於2020 年2 月和8 月公開發行普通股。如果您還記得，我們​​在 8 月完成了一次承銷公開發行，籌集了 2,300 萬美元的總收益或 2,120 萬美元的淨收益。 2 月份，我們完成了一次發行，籌集了 850 萬美元的總收益或 770 萬美元的淨收益。

Our current capital position should allow us to complete a number of significant milestones for DiaMedica, including data readouts for all 3 cohorts of our REDUX Phase II CKD study, along with initiating our Phase II/III study in the acute ischemic stroke and further fund our planned operations into the third quarter of 2020.

我們目前的資本狀況應該使我們能夠完成DiaMedica 的許多重要里程碑，包括我們REDUX II 期CKD ​​研究的所有3 個隊列的數據讀出，以及啟動我們針對急性缺血性中風的II/III 期研究，並進一步資助我們的計劃營運至2020年第三季。

Now let me turn the call back over to Rick.

現在讓我把電話轉回給里克。

Thank you, Scott. We'd like to open the call for questions. Operator, if you could please introduce the first analyst.

謝謝你，斯科特。我們想開始提問。接線員，請您介紹第一位分析師。

Your first question comes from Alex Nowak from Craig-Hallum.

你的第一個問題來自 Craig-Hallum 的 Alex Nowak。

Maybe could you just speak to on the label expansion to include stroke reoccurrences. How would that work? Do you anticipate that the single pivotal Phase II/III study would support that label alone for stroke reoccurrences? And frankly, is there enough powering in that 350 patients to get an indication? What have you been hearing from the FDA?

也許您可以談談標籤擴展以包括中風復發。那會如何運作呢？您是否預期單一關鍵的 II/III 期研究將支持單獨針對中風復發的標籤？坦白說，這 350 名患者是否有足夠的力量來獲得指示？您從 FDA 聽到了什麼？

Yes. Thanks, Al. So our plan is surely after filing our IND for the planned Phase II/III. We plan to reach out to the FDA and request a meeting to discuss the clinical path and the powering. We do believe that based upon the profile of our therapy for stroke reoccurrence there is -- it's truly a real potential. And this is something that we wanted to get clarity with the FDA first.

是的。謝謝，艾爾。因此，我們的計劃肯定是在為計劃的第二/第三階段提交 IND 後。我們計劃聯繫 FDA 並要求召開會議討論臨床路徑和動力。我們確實相信，根據我們對中風復發的治療方案，它確實具有真正的潛力。這是我們希望首先向 FDA 澄清的事情。

So that decision will come later. It sounds like, okay. Maybe from the feedback you got from the FDA back in December, what did they say around fast track or breakthrough designation? And when would you plan to submit for those 2 labels?

所以這個決定會稍後再做出。聽起來好像，好吧。也許從 12 月 FDA 收到的回饋來看，他們對快速通道或突破性指定有何評論？您計劃何時提交這兩個標籤？

Yes. So our plan is shortly after filing our IND that we will be filing for fast track designation. And then based upon our discussions with the FDA, we'll look at other pathways for expedited approval.

是的。因此，我們的計劃是在提交 IND 後不久，我們將申請快速通道指定。然後根據我們與 FDA 的討論，我們將尋找其他加快批准的途徑。

And then any update on the timing to run the pivotal stroke study? Just how long will that take? And what sort of costs, all in for 350 patients? And has there been any discussion about partnering on stroke to include participants outside the U.S.

那麼進行關鍵中風研究的時間有什麼更新嗎？這需要多長時間？ 350 名患者的全部費用是多少？是否有任何關於在中風領域開展合作以將美國以外的參與者納入其中的討論？

Yes. So the -- based upon the powering on a 90% powering, we're anticipating approximately 350 patients overall. That study will start this summer. And we're planning to have an interim analysis after about halfway through. And right now, we're planning for that to happen next year in 2022 and then ideally to finish the study in 2023. The overall cost of that study will be close to $30 million for the 350 patients. And then in terms of partnering, we're always having discussions, ongoing discussions right now, our real focus, though, is getting this IND filed, getting the chronic kidney disease cohorts completed. And I think after that point in time, I think we'll be in a much better position. Both looking for a partner in Asia and globally.

是的。因此，基於 90% 的供電，我們預計總共有約 350 名患者。這項研究將於今年夏天開始。我們計劃在大約一半後進行中期分析。目前，我們計劃在明年 2022 年完成這項研究，然後最好在 2023 年完成這項研究。對於 350 名患者來說，這項研究的總成本將接近 3,000 萬美元。然後在合作方面，我們一直在進行討論，現在正在進行討論，但我們真正的重點是提交 IND 申請，完成慢性腎病隊列。我認為在那之後，我認為我們的處境會好得多。雙方都在亞洲和全球尋找合作夥伴。

And then you mentioned in the press release that you do intend to take the drug forward in IgA nephropathy and that's even before seeing the data. Just -- am I reading that correctly, and perhaps speak to why you picked this indication now before you've even seen the 3 cohorts of data? And I guess how closely should the upcoming DKD results correlate to IgA population?

然後您在新聞稿中提到您確實打算將該藥物用於治療 IgA 腎病，而這甚至是在看到數據之前。只是——我讀得是否正確，也許在你看到這 3 組數據之前，談談你為什麼現在選擇這個指示？我想即將到來的 DKD 結果與 IgA 族群的相關性應該有多密切？

Yes, so as we look at the clinical -- the regulatory path for these different cohorts, we see a very clear path for IgA nephropathy rare form, there are a number of other recent compounds that are moving into pivotal studies for IgA nephropathy. So we think this is the clearest path for us moving forward. And so how we see the potential for DM199 for kidney disease is the potential to start off in the rare. And then longer term, us sort of partner moving into the overall CKD or diabetic kidney disease. And part of that just comes to today, the size and the cost of running a pivotal study for diabetic kidney disease is much larger. So how we see it and the rationale for this pathway here is, again, we can see a clear path for the IgA. And then longer term, we could see a partner having interest in taking this to the overall CKD or DKD patient population.

是的，所以當我們觀察這些不同群體的臨床調節路徑時，我們看到了 IgA 腎病罕見形式的非常清晰的路徑，還有許多其他最近的化合物正在進入 IgA 腎病的關鍵研究。所以我們認為這是我們前進的最清晰的道路。因此，我們如何看待 DM199 治療腎臟疾病的潛力，是從罕見的情況開始的。長遠來看，我們會成為慢性腎臟病（CKD）或糖尿病腎病變的夥伴。其中一部分直到今天，針對糖尿病腎病變進行關鍵研究的規模和成本要大得多。因此，我們如何看待它以及這條路徑的基本原理是，我們可以再次看到 IgA 的清晰路徑。從長遠來看，我們可能會看到合作夥伴有興趣將其推廣到整個 CKD 或 DKD 患者群體。

And then just a correlation of DKD results to IgA.

然後只是 DKD 結果與 IgA 的相關性。

I think, ultimately, one of the differences between DKD and IgA is that we feel that for the IgA, there's a potential immunomodulating effect. But again, I think we're optimistic for all 3 cohorts, and we plan to follow the data.

我認為，歸根結底，DKD 和 IgA 之間的區別之一是我們認為 IgA 具有潛在的免疫調節作用。但同樣，我認為我們對所有 3 個隊列都持樂觀態度，並且我們計劃追蹤數據。

Your next question comes Etzer Darout, Guggenheim.

你的下一個問題來自古根漢的埃澤·達魯特（Etzer Darout）。

Just the first one on stroke. Just wanted to know if you had any further color on which mechanism -- or sorry, which medications won't be allowed beyond alteplase in the stroke Phase II/III study?

只是第一個中風。只是想知道您是否對哪種機制有任何進一步的了解——或者抱歉，在中風 II/III 期研究中除了阿替普酶之外，哪些藥物不允許使用？

Sure. The protocol is currently being developed and finalized in the inclusion/exclusion criteria, which we've delineated being, they will not be allowed to be on TPA or receive TPA or mechanical thrombectomy. Beyond that, we will look at each patient individually, but that's the only 2 exclusions at this point for this patient population.

當然。該方案目前正在製定並最終確定納入/排除標準，我們已經規定，他們將不允許接受 TPA 或接受 TPA 或機械血栓切除術。除此之外，我們將單獨查看每位患者，但這是該患者群體目前唯一的 2 個排除項。

And then just quickly on kidney. So IgA nephropathy diabetic kidney disease seems to be pretty clearly defined population. Just wondered, do regulators view the hypertensive African-American with CKD cohorts the same way as other sort of CDK indications in terms of UACR and eGFR, I guess either death decline or the improvements that would be needed by new therapies in that particular indication?

然後很快就腎了。因此，IgA 腎病變、糖尿病腎病變似乎是一個相當明確的族群定義。只是想知道，監管機構是否將患有CKD 的高血壓非裔美國人與其他類型的CDK 適應症（在UACR 和eGFR 方面）視為相同的方式，我想要么是死亡率下降，要么是該特定適應症的新療法所需的改進？

Yes, that is correct, especially with UACR, there was a meeting just last week on CKD 3, where the agency weighed in, in regards to the fact that they're looking at UACR directly as for kidney improvement along with eGFR, respectively.

是的，這是正確的，特別是對於 UACR，上週就 CKD 3 舉行了一次會議，該機構在會議上進行了權衡，因為他們分別直接關注 UACR 和 eGFR 來改善腎臟。

Your next question comes from Elemer Piros from ROTH Capital Partners.

您的下一個問題來自 ROTH Capital Partners 的 Elemer Piros。

What I'd like to ask is, Rick, as you outlined that you would pursue IgA nephropathy as an orphan indication. If then subsequently, there is a partner who would develop it for other kidney indications, how would you tackle the potential pricing differential in the different therapeutic indications?

我想問的是，Rick，正如您概述的那樣，您將把 IgA 腎病作為孤兒適應症。如果隨後有合作夥伴將其開發用於其他腎臟適應症，您將如何解決不同治療適應症的潛在定價差異？

Yes. So that's -- so a great question. So how we see this and we actually recently have engaged a consulting company to help us to first answer the question is that, can we co-position DM199 for both stroke and kidney disease? And the bottom line, the feedback was that we feel those will be distinct products. They'll have different NDC numbers. From a prescriber's perspective, the stroke product will be prescribed in a hospital setting, whereas the kidney disease and particularly the rare will be done from a nephrologist. So both indications, and then that partner could manage. Right now, our focus is getting as much data as we can and positioning ourselves here to find the right partner. We don't have intentions to commercialize ourselves, but we do can move this forward and again, find the right partner for both indications.

是的。所以這是一個很好的問題。那麼我們如何看待這一點，實際上我們最近聘請了一家諮詢公司來幫助我們首先回答這個問題：我們可以將 DM199 聯合用於中風和腎臟疾病嗎？最重要的是，回饋是我們認為這些將是獨特的產品。他們會有不同的 NDC 號碼。從處方者的角度來看，中風產品將在醫院開出處方，而腎臟疾病（尤其是罕見疾病）將由腎臟科專家進行。因此，這兩個跡象，然後該合作夥伴都可以管理。目前，我們的重點是獲取盡可能多的數據，並定位自己以尋找合適的合作夥伴。我們無意將自己商業化，但我們確實可以不斷向前推進，為這兩種適應症找到合適的合作夥伴。

And the next question would be what new data do you anticipate to release at next week's stroke conference?

下一個問題是您預計在下週的卒中會議上發布哪些新數據？

There is some potential new data that could be coming, but we'll have to hold off until that event. So it'll be great to join in on the call on March 19th.

可能會有一些潛在的新數據出現，但我們必須推遲到該事件發生為止。因此，很高興參加 3 月 19 日的電話會議。

Your next question comes from Thomas Flaten from Lake Street Capital Markets.

您的下一個問題來自 Lake Street Capital Markets 的 Thomas Flaten。

Just a couple of follow-ups on stroke. Is -- are large vessel occlusions still part of the exclusion criteria?

只是對中風進行了幾次追蹤。大血管閉塞仍然是排除標準的一部分嗎？

Large vessel occlusions will be excluded, which will automatically exclude mechanical thrombectomy.

將排除大血管閉塞，這將自動排除機械血栓切除術。

Yes. And then just going back to the sub-study on stroke recurrence. So if you're going to submit the protocol as part of the IND, obviously, will -- how would you then reintegrate a potential sub-study? Would that require an amendment? Would that potentially lead to a slow down in enrollment or a pause? Can you help me just think through the mechanics of how that would work?

是的。然後再回到中風復發的子研究。因此，如果您打算將方案作為 IND 的一部分提交，那麼您將如何重新整合潛在的子研究？這需要修改嗎？這是否會導致招生速度放緩或暫停？你能幫我想一下它是如何運作的嗎？

Yes. So we'll be filing the application with stroke reoccurrence as a key secondary endpoint. And then after we get clarity from the FDA and based upon those discussions, we'll look at the potential for a subgroup study. But we don't -- we do not anticipate this will slow down any aspects of the study or deposit, yes.

是的。因此，我們將在提交申請時將中風復發作為關鍵的次要終點。然後，在我們從 FDA 獲得明確資訊並根據這些討論後，我們將研究進行亞組研究的可能性。但我們不會——我們預計這不會減慢研究或存款的任何方面，是的。

And then one for Scott. With, I guess, a bit of a slow down on the CKD enrollment and then the pick up as you start the stroke study, how should we think about spending pacing over the course of the year?

然後是史考特的一份。我想，隨著 CKD 註冊人數的放緩，然後隨著中風研究的開始，註冊人數增加，我們應該如何考慮全年的支出節奏？

Well, it's a little -- it's chunky, obviously. So as we wrap up the enrollment in the -- in REDUX, the spending will decline a little bit. Of course, that's offset by a start-up on the stroke study. So you'll probably see a slowdown midyear and then a ramp back up towards the end of the year as the site activations commence.

嗯，它有點——顯然很粗。因此，當我們結束 REDUX 的註冊時，支出將略微下降。當然，這被中風研究的新創公司所抵消。因此，您可能會在年中看到經濟放緩，然後隨著站點激活的開始，到年底又回升。

There is no further question at this time. I'd like to turn the call over back to Mr. Pauls.

目前沒有進一步的問題。我想把電話轉回給保羅斯先生。

All right. Again, we would like to thank everyone for joining us this morning. We appreciate your interest and continued support. Please stay safe in these challenging times. And with this, this concludes our call today.

好的。我們再次感謝大家今天早上加入我們。我們感謝您的關注和持續的支持。在這個充滿挑戰的時期，請保持安全。我們今天的電話會議到此結束。