DiaMedica Therapeutics Inc (DMAC) 2026 Q1 法說會逐字稿

Good morning, ladies and gentlemen, and welcome to the DiaMedica Therapeutics first-quarter 2026 earnings conference call. An audio recording of this webcast will be made available shortly after the call today on DiaMedica's website at www.diamedica.com in the Investor Relations section.

各位女士、先生，早安，歡迎參加 DiaMedica Therapeutics 2026 年第一季財報電話會議。本次網路直播的音訊錄影將於今日會後不久，於 DiaMedica 網站 www.diamedica.com 的「投資人關係」專區提供。

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.

在公司開始發言之前，請注意公司將於今日電話會議中發表前瞻性陳述。此等陳述受各項風險與不確定性影響，可能導致實際結果與該等陳述所預期或推估者出現重大差異。

More information, including factors that could cause actual results to differ from projected results appear in the sections entitled Cautionary Statement Notes regarding Forward-Looking Statements in the company's press release issued yesterday under the heading Risk Factors in DiaMedica's most recent annual report on Form 10-K and most recent quarterly report on Form 10-Q.

更多資訊（包括可能導致實際結果與預期結果不同的因素）載於公司昨日發布之新聞稿中「關於前瞻性陳述之警語聲明附註」章節，以及 DiaMedica 最近一期 Form 10-K 年報與最近一期 Form 10-Q 季報中「風險因素」標題下之相關內容。

DiaMedica's SEC filings are available at www.sec.gov and on its website. Please note that any comments made on today's call speak only as of today, May 7, 2026, and may no longer be accurate at the time of any replay or transcript rereading. Please -- following management's remarks, we will open the phone lines for Finalquestions.

DiaMedica 向 SEC 提交的文件可於 www.sec.gov 及公司網站查閱。另請注意，今日電話會議中的任何評論僅以今日（2026 年 5 月 7 日）為準，於任何重播或逐字稿再次閱讀時可能已不再準確。請注意——在管理層發言結束後，我們將開放電話線路進行最後提問。

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.

現在我想介紹今日電話會議的主持人：DiaMedica 總裁兼執行長 Rick Pauls。Pauls 先生，請開始。

Thank you, operator, and thank you all for joining us today. With me this morning are Dr. Julie Krop, our Chief Medical Officer; and Scott Kellen, our Chief Financial Officer. Given that our last call was only five weeks ago, we'll try to keep our remarks short. We are pleased with the progress we've made so far in 2026 as we continue to advance DM199 across both our preeclampsia and acute ischemic stroke programs.

謝謝接線員，也謝謝各位今天加入我們。今天早上與我一同出席的還有：我們的首席醫療長 Julie Krop 醫師，以及我們的財務長 Scott Kellen。由於我們上次的電話會議距今僅五週，我們會盡量簡短。我們對 2026 年迄今所取得的進展感到滿意，並持續推進 DM199 在子癲前症與急性缺血性腦中風兩項計畫中的發展。

Most importantly, for our shareholders, we're poised to deliver multiple clinical milestones between now and the end of 2027, all of which could provide significant validation of the value of DM199. We also weigh the risks and advantages of providing interim updates as clinically meaningful data emerges ahead of formal readouts.

對股東而言最重要的是，我們有望在現在到 2027 年底之間達成多項臨床里程碑，這些里程碑皆可能為 DM199 的價值提供重要驗證。我們也會在具臨床意義的數據於正式揭盲/讀出之前逐步浮現時，權衡提供期中更新的風險與優勢。

We're particularly interested in completing the interim analysis for our stroke program. We've been working diligently on the ReMEDy2 stroke trial for a long time, battling through some significant challenges emanating from the COVID pandemic. With enrollment having surpassed 70%, we expect that the interim analysis will validate all of the hard work that has gone into the program.

我們特別關注完成中風計畫的期中分析。我們在 ReMEDy2 腦中風試驗上已長期投入並努力推進，同時也克服了 COVID 疫情所帶來的一些重大挑戰。隨著收案已超過 70%，我們預期期中分析將能驗證此計畫投入的所有努力成果。

I now turn the call over to Julie to provide additional detail on our preeclampsia and stroke programs.

接下來我把電話交給 Julie，請她就我們的子癲前症與中風計畫提供更多細節。

Thank you, Rick. In the Phase II investigator-sponsored trial, enrollment is near completion in the extension cohort for the Part 1a dose escalation study in late-onset preeclampsia patients. Late onset patients are planned to deliver within 72 hours. This cohort will allow us to detect the dose or doses we plan to use for the upcoming cohorts of the IST. We expect to complete this cohort and provide a data update later this quarter.

謝謝你，Rick。在第二期研究者發起（investigator-sponsored）的試驗中，針對晚發型子癲前症患者之 Part 1a 劑量遞增研究，其延伸隊列的收案已接近完成。晚發型患者計畫於 72 小時內分娩。此隊列將協助我們辨識在即將進行之 IST 後續隊列中擬採用的劑量或劑量組合。我們預期將於本季稍晚完成此隊列並提供數據更新。

As you may recall, the interim results from this study demonstrated DM199's potential to reduce blood pressure and improve placental perfusion without crossing the placental barrier. While we only have data in a relatively small number of patients, the results we observed were highly consistent and encouraging.

各位或許記得，本研究的期中結果顯示 DM199 具有降低血壓並改善胎盤灌流、且不會穿越胎盤屏障的潛力。雖然目前僅有相對少數患者的數據，但我們觀察到的結果高度一致且令人鼓舞。

We look forward to sharing the data from the extension cohort to further support the interim results. Additionally, learnings from Part 1a are guiding protocol amendments for the two remaining preeclampsia study groups. The first group referred to as Part 1b is an expansion study with up to 30 additional late-onset preeclampsia patients who will receive DM199 as a continuous IV infusion until delivery.

我們期待分享延伸隊列的數據，以進一步支持期中結果。此外，Part 1a 的學習成果正用於指引其餘兩個子癲前症研究組別的試驗方案修訂。第一個組別稱為 Part 1b，為擴增研究，將再納入最多 30 名晚發型子癲前症患者，並以持續靜脈（IV）輸注方式給予 DM199 直至分娩。

In this cohort, we hope to learn more about the ability of doctors to use DM199 to effectively support blood pressure control management at this late stage of the disease. The second part referred to as Part 2 will study up to 30 early onset preeclampsia patients. Three doses will be evaluated to support dosing for a Phase III trial and an optimal dose level to extend the time mom is able to carry the baby, increasing the gestational age at the delivery.

在此隊列中，我們希望進一步了解醫師在疾病晚期使用 DM199 以有效支持血壓控制管理的能力。第二部分稱為 Part 2，將研究最多 30 名早發型子癲前症患者。將評估三種劑量，以支持第三期試驗的劑量選擇，並找出最佳劑量水準以延長母親能夠繼續妊娠的時間，進而提高分娩時的胎齡。

As you've seen in our investor presentations, the medical complications for the baby are expected to decrease significantly the longer mom carries the baby. With the potential for DM199 to help manage blood pressure and improve blood flow to the placenta, we believe DM199 has a chance to be a transformative therapy for preeclampsia. Initiation of these two preeclampsia cohorts which will recruit concurrently, is expected to begin after the completion of the ongoing Part 1a extension cohort.

如各位在我們的投資人簡報中所見，母親妊娠時間越長，嬰兒的醫療併發症預期將顯著降低。鑑於 DM199 可能有助於管理血壓並改善胎盤血流，我們相信 DM199 有機會成為子癲前症的變革性療法。這兩個子癲前症隊列將同步招募，預期在目前進行中的 Part 1a 延伸隊列完成後啟動。

The IST also includes a study in women experiencing fetal growth restriction. In this group, we will be evaluating the effects of DM199 on fetal growth restriction in patients without preeclampsia. FGR is a condition with diminished fetal growth due to a poorly functioning placenta, the life support system of the unborn child.

IST 亦包含一項針對胎兒生長受限（fetal growth restriction, FGR）女性的研究。在此組別中，我們將評估 DM199 對於未合併子癲前症之 FGR 患者的影響。FGR 是一種因胎盤功能不良（胎兒的生命支持系統）而導致胎兒生長減緩的狀況。

FGR is the leading cause of stillbirth and for infants that survive the FGR pregnancy, it is associated with enduring adverse health effects over the child's lifespan. In this cohort, we will evaluate the potential for DM199 to increase placental perfusion and improve fetal development. Enrollment of the first patient for this study is expected in the current quarter.

FGR 是死胎的主要原因；而對於在 FGR 妊娠中存活下來的嬰兒，FGR 亦與其一生中持續的不良健康影響相關。在此隊列中，我們將評估 DM199 增加胎盤灌流並改善胎兒發育的潛力。預期本季將完成此研究的首位患者收案。

In parallel with the IST, we are advancing our global Phase II study in early onset preeclampsia. We intend to conduct this study in North America, both the United States and Canada and the United Kingdom. In March 2026, we received approval from Health Canada to initiate this study and study sites have been selected. We are working to initiate enrollment in Canada by the end of this year.

在推進 IST 的同時，我們也在推進早發型子癲前症的全球第二期研究。我們計畫在北美（美國與加拿大）以及英國進行此研究。2026 年 3 月，我們已取得加拿大衛生部（Health Canada）核准啟動此研究，並已選定研究中心。我們正努力在今年底前於加拿大啟動收案。

We expect to file a clinical trial application in the UK in the current quarter. With respect to the status of the IND submission in the United States, as we discussed previously, the FDA requested an additional nonclinical 10-day modified embryo fetal development and pre- and postnatal development study in a rabbit model.

我們預期將於本季在英國提交臨床試驗申請。至於美國 IND 申請的狀態，如我們先前所討論，FDA 要求在兔子模型中進行一項額外的非臨床 10 天改良胚胎—胎兒發育研究，以及產前與產後發育研究。

Results of a non-GLP dose-ranging study in rabbit suggest that the animals developed an adverse immune response to DM199, preventing us from completing the requested modified pre- and postnatal development study in a rabbit model. We have proposed to the FDA performing this study in a second rodent model and are awaiting their response.

兔子之非 GLP 劑量範圍探索研究結果顯示，動物對 DM199 產生不良免疫反應，使我們無法完成 FDA 要求的兔子模型改良產前與產後發育研究。我們已向 FDA 提議改在第二種囓齒類動物模型中執行該研究，目前正等待其回覆。

That said, I would highlight for everyone that we are moving forward in parallel with the study in Canada and are planning to add UK sites while we complete any additional preclinical work requested by the FDA. This study will evaluate three dose groups of DM199 in patients with early onset preeclampsia to further establish safety, pharmacokinetics and pharmacodynamics in a more ethnically diverse patient group prior to initiating a registration study.

即便如此，我仍要向各位強調：我們正與加拿大的研究同步推進，並計畫在完成 FDA 可能要求的任何額外臨床前工作期間，加入英國的研究中心。本研究將在早發型子癲前症患者中評估 DM199 的三個劑量組，以在啟動註冊性研究之前，於更具族群多樣性的患者群中進一步建立其安全性、藥物動力學與藥效學。

Turning now to our stroke program. We are encouraged by the continued progress on the ReMEDy2 trial. Enrollment has now surpassed 70% of the target required for the interim analysis. Site activations and enrollments have recently commenced in Europe as well. In addition to the United States, Canada and the UK, we've added six additional European countries and now have approximately 70 sites activated.

接著談我們的中風計畫。我們對 ReMEDy2 試驗持續取得的進展感到鼓舞。收案目前已超過進行期中分析所需目標的 70%。歐洲地區的研究中心啟動與收案近期也已開始。除美國、加拿大與英國外，我們新增了六個歐洲國家，目前約有 70 個研究中心已啟動。

In April, we sponsored an investigator meeting for our European study team that was well attended and had many productive sessions and discussions, which we believe are the key to getting the study teams excited about and focused on patient enrollment. And we are reiterating our intention to complete the interim analysis by the end of 2026.

4 月，我們為歐洲研究團隊主辦了一場研究者會議，出席踴躍，並進行了多場富有成效的會議與討論；我們相信，這些是讓研究團隊對病患收案感到振奮並保持專注的關鍵。我們也再次重申，我們的目標是在 2026 年底前完成期中分析。

As a reminder, in the Phase II ReMEDy1 stroke study, treatment with DM199 was associated with clinically meaningful improvements in functional outcomes for the patient group that most closely resembles the patients enrolling in our ReMEDy2 trial. In the subset of patients that did not undergo a thrombectomy, we observed a 15% absolute increase over placebo in the proportion of patients achieving favorable recovery as measured by a score of zero or one on the modified Rankin Scale.

提醒一下，在第二期 ReMEDy1 腦中風研究中，DM199 治療與臨床上具意義的功能性結局改善相關，而該受試者族群與我們 ReMEDy2 試驗目前收案的病患最為相近。在未接受血栓切除術（thrombectomy）的病患子集中，我們觀察到：以改良 Rankin 量表（modified Rankin Scale）0 分或 1 分衡量之達到良好復原的病患比例，相較安慰劑組有 15% 的絕對提升。

Furthermore, ReMEDy2 is enrolling patients presenting with moderate stroke severity defined as an NIHSS score between 5 and 15. Looking at that subgroup in the ReMEDy1 study, there was a 19% absolute improvement over placebo in functional outcomes. There was also a 50% reduction in the number of patient deaths and a 13.3% reduction in recurrent strokes compared to placebo. These data inform the design and powering assumptions for the ongoing ReMEDy2 trial. I think you can understand why we are eagerly awaiting the results of the interim analysis.

此外，ReMEDy2 正在收納中度中風嚴重度的病患，其定義為 NIHSS 分數介於 5 至 15。回看 ReMEDy1 研究中的該子群，相較安慰劑組，功能性結局有 19% 的絕對改善。同時，病患死亡人數減少 50%，且相較安慰劑組，復發性中風降低 13.3%。這些數據為目前進行中的 ReMEDy2 試驗之設計與樣本數估算（powering assumptions）提供依據。我想各位可以理解，為何我們正殷切期待期中分析的結果。

Let me now turn the call back to Rick.

接下來我把電話交回給 Rick。

Thanks, Julie. I'd like to now ask Scott to review the financial results for the quarter.

謝謝，Julie。接下來我想請 Scott 回顧本季的財務結果。

Thank you, Rick, and good morning, everyone. We announced our first quarter 2026 financial results and filed our quarterly report on Form 10-Q yesterday after the markets closed. As of March 31, 2026, our cash, cash equivalents and short-term investments were $51.3 million, current liabilities were $5.7 million and working capital was $46.6 million compared to cash and investments of $59.9 million, current liabilities of $5.1 million and working capital of $55.5 million as of December 31, 2025.

謝謝你，Rick，各位早安。我們在昨天收盤後公布了 2026 年第一季財務結果，並提交了 Form 10-Q 季度報告。截至 2026 年 3 月 31 日，我們的現金、約當現金及短期投資為 5,130 萬美元，流動負債為 570 萬美元，營運資金為 4,660 萬美元；相較之下，截至 2025 年 12 月 31 日，現金及投資為 5,990 萬美元，流動負債為 510 萬美元，營運資金為 5,550 萬美元。

We anticipate that our current cash and investments will be sufficient to fund our planned clinical studies and operations through 2027. Net cash used in operating activities for the first quarter of '26 was $9.1 million compared to $7.1 million for the first quarter of 2025. The increase in cash used in operating activities resulted primarily from the increased net loss for the current year period, partially offset by changes in operating assets and liabilities during the current year quarter.

我們預期目前的現金與投資足以支應我們規劃中的臨床研究與營運至 2027 年。2026 年第一季營運活動使用之淨現金為 910 萬美元，較 2025 年第一季的 710 萬美元增加。營運活動使用現金增加，主要是因本年度同期淨損擴大所致，部分被本季營運資產與負債變動所抵銷。

Turning to the income statement. Our research and development expenses increased to $8 million for the three months ended March 31, 2026, up from $5.7 million for the same period in the prior year. The increase is due primarily to the increased costs resulting from the continuation of our ReMEDy2 clinical trial and its global expansion, the expansion of our clinical team and costs related to additional reproductive toxicity testing being performed in support of our PE program in the United States.

接著看損益表。我們截至 2026 年 3 月 31 日止三個月的研發費用增至 800 萬美元，高於前一年度同期的 570 萬美元。增加主要來自：ReMEDy2 臨床試驗持續進行及其全球擴展所帶來的成本上升、臨床團隊擴編，以及為支持我們在美國的 PE 計畫而進行的額外生殖毒性測試相關成本。

These increases were partially offset by net cost reductions in manufacturing development activity related to work performed and completed in the prior year period. We expect that our R&D expenses will moderately increase in future periods relative to recent prior periods as we continue our ReMEDy2 trial and continue to advance our DM199 clinical development program into PE.

上述增加部分被製造開發活動的淨成本下降所抵銷，該下降與前一年度同期已執行並完成的工作相關。我們預期，隨著我們持續推進 ReMEDy2 試驗，並持續將 DM199 臨床開發計畫推進至 PE，未來期間的研發費用相較近期前期期間將溫和增加。

Our general and administrative expenses were $2.5 million for the three months ended March 31, 2026, and 2025. While small changes occurred within a number of expense categories, the differences were not material individually or in the aggregate and the overall net changes offset each other. We expect G&A expenses to remain relatively consistent in future periods as compared to recent prior periods.

我們截至 2026 年 3 月 31 日止三個月的一般及行政費用於 2026 年與 2025 年皆為 250 萬美元。雖然多個費用類別出現小幅變動，但無論單項或合計皆不具重大性，且整體淨變動彼此抵銷。我們預期未來期間的 G&A 費用相較近期前期期間將維持相對一致。

With that, let me ask the operator to open the lines for questions.

接下來，請接線員開放提問。

(Operator Instructions)

（接線員指示）

Josh Schimmer, Cantor.

Josh Schimmer，Cantor。

Thanks for taking this question. The preeclampsia data updates that we'll get this quarter for the late onset cohort, what incremental observations should we be looking for beyond blood pressure control? Obviously, preeclampsia can affect urine output, kidney function, liver function platelets and biomarkers like sFlt. At what point will you have data to share on those parameters?

謝謝讓我提問。本季我們將取得晚發型（late onset）隊列的子癲前症數據更新，除了血壓控制之外，我們還應該關注哪些新增觀察指標？顯然，子癲前症會影響尿量、腎功能、肝功能、血小板以及像 sFlt 這類生物標記。你們何時會有這些參數可分享的數據？

Yes. Thanks, Josh. So the expansion cohort that we're running is going to be 12 additional patients. We're almost completing that right now. It's going to be at the cohort 10 from the Part 1a. And so it's really just going to give us additional clarification here, particularly on blood pressure, dilation of the intrauterine arteries.

是的，謝謝你，Josh。我們正在進行的擴增隊列將再納入 12 名病患，我們目前幾乎已完成。這將是在 1a 部分的第 10 隊列。因此，這主要是要為我們提供更多釐清，特別是在血壓以及子宮內動脈擴張方面。

At this point, we're really not expecting any changes in some of the biomarkers like sFlt because these patients really only got two doses. It's really we believe that having the drug on board for ideally a week, two weeks that we really would see some of those biomarkers improve.

就目前而言，我們其實不預期像 sFlt 這類生物標記會有任何變化，因為這些病患實際上只接受了兩次給藥。我們認為，理想情況下需要讓藥物在體內維持一週、兩週，才會真正看到其中一些生物標記改善。

Okay. Got it. So I think at one point, the lead investigators suggested that there was an improvement in edema at the very least maybe might be something that can improve within a short period of time. Is that something you're looking for?

好的，了解。所以我記得有一次主要研究者提到，至少水腫（edema）有所改善，或許是能在短時間內改善的項目。這是你們正在觀察的嗎？

Yes, that's something that if there is an improvement in endothelial health, and it is something that Dr. Cathy Cluver very clearly seen in some of these patients that the edema did resolve even within 12 to 24 hours of getting DM199, which is encouraging. It's a small number of patients, but we'll be looking to see maybe there's some additional insight there as well.

是的，如果內皮健康（endothelial health）有所改善，水腫確實可能改善。Cathy Cluver 醫師在部分病患身上非常清楚地看到，水腫甚至在接受 DM199 後 12 到 24 小時內就消退，這令人鼓舞。雖然病患數量不多，但我們也會觀察是否能從中獲得更多額外洞見。

Just a couple of other quick questions, if I may. What are the steps to start initiating enrollment in the early onset preeclampsia study? Why is that not going to occur until later this year?

如果可以的話，我再快速問兩個問題。啟動早發型（early onset）子癲前症研究收案需要哪些步驟？為什麼要到今年稍晚才會發生？

Yes. Julie, do you want to take that one?

是的。Julie，你要回答這題嗎？

Yes. Are you referring to the IST cohort? Or are you referring to the -- to our sponsored trial?

好的。你指的是 IST 隊列嗎？還是指——指我們主辦的試驗？

Sponsored trial.

主辦的試驗。

Yes. We are in the midst of getting our dosing data from -- again, from the IST study before we select our final doses for that protocol as well as getting sites contracted up and running and our CRO selection process, all of that completed and then we'll be initiating. So it's a combination of factors, but we should be again in Canada later this year.

好的。我們正在取得——再次強調，是從 IST 研究取得——我們的給藥數據，之後才會為該試驗方案選定最終劑量；同時也在進行研究中心簽約並啟動，以及 CRO 選擇流程等，待這些都完成後就會啟動。因此是多項因素的組合；不過我們應該會在今年稍晚於加拿大展開。

And then last sorry --

然後最後一題，抱歉——

Sorry, if I can add. And so importantly, as we mentioned, so we have selected the 2 sites in Canada and one site in particular, is already in our stroke trial. So we're looking forward to leveraging the relationships, the existing contract that we have to basically doing what we can to expedite and get those sites activated as soon as we can.

抱歉，我補充一下。更重要的是，如同我們提到的，我們已在加拿大選定 2 個研究中心，其中 1 個中心已參與我們的中風試驗。因此我們期待能善用既有合作關係與現有合約，盡我們所能加速流程，讓這些中心儘快啟動。

Got it. And then last question, timelines for completing the second animal toxicology study and then ultimately reengaging with the FDA for IND.

了解。最後一題：完成第二項動物毒理研究的時程，以及之後最終與 FDA 重新接洽以推進 IND 的時程？

Yes. So it will really depend on the feedback that we get from the FDA. And so it is a rat study that we proposed. And if they agree to that, that's a matter of a few months, probably three to four months to complete. And so again, while that's all happening, we'll be running the Phase II in Canada and then expanding to the UK.

好的。這將主要取決於我們從 FDA 收到的回饋。我們提出的是一項大鼠研究；若他們同意，完成大約需要幾個月，可能三到四個月。因此，同時在這些進行期間，我們會在加拿大執行第二期試驗，之後再擴展到英國。

Thanks very much. Appreciate it.

非常感謝。感激不盡。

Stacy Ku, TD Cowen.

Stacy Ku，TD Cowen。

Hey, good morning, everyone. So we have a couple of questions. So I guess, first, follow-ups. When could you expect to hear from the FDA on the mouse study? And is there a possibility the FDA could ask for another animal model? And how are you looking to prepare for all these different scenarios?

各位早安。那我們有幾個問題。我想先從追問開始。你們預計何時會收到 FDA 對小鼠研究的回覆？FDA 是否有可能要求使用另一種動物模型？你們打算如何為這些不同情境做準備？

It sounds like the rat study is pretty straightforward, but just help us understand how you view the next two necessary steps. And again, just to clarify, it sounds like you are expecting a potential study initiation of the global Phase II by year-end. Just want to make sure you're reiterating that time line.

聽起來大鼠研究相當直接，但請協助我們理解你們如何看待接下來兩個必要步驟。另外再確認一次，聽起來你們預期全球第二期（Phase II）可能在年底前啟動研究。只是想確認你們是否重申這個時間表。

And then we're looking forward to the updated preeclampsia results in Q2. But as we think about the early onset preeclampsia or fetal growth restriction subgroups of the IST, could we think about any potential for low-dose updates by year-end for either of these groups? And then, Julie, just a clarification again, what is the timing of potentially starting the early onset preeclampsia IST? And then last, just a reminder, what's the go and no-go decisions on the interim results for stroke? I can repeat some of these questions.

另外，我們也期待在第二季（Q2）看到更新的子癲前症結果。但當我們思考 IST 中早發型子癲前症或胎兒生長受限（FGR）子群時，是否可能在年底前針對其中任一族群提供低劑量的更新？還有，Julie，再請澄清一次，可能何時開始早發型子癲前症的 IST？最後提醒一下，中期結果對中風試驗的 go/no-go 決策標準是什麼？我可以再重複其中一些問題。

Okay. Great. So we'll try to take those. I'll start off here. Maybe Julie, you can help me out here. So in terms of the -- we did our submission to the FDA over a month ago. And so we're just waiting to hear the feedback. So as soon as we get clarity from the FDA, we'll provide an update. We have looked at alternative kind of backup plans in case they want something different. But we think we've got a very strong rationale for the proposed rat study.

好的。很好。我們會試著逐一回答。我先開始，Julie 也許你可以幫我補充。就 FDA 的部分而言——我們在一個多月前已向 FDA 提交資料，目前正在等待回饋。所以一旦我們從 FDA 得到明確答覆，就會提供更新。我們也已評估一些替代性的備援方案，以防他們要求不同的內容。但我們認為我們所提議的大鼠研究有非常強而有力的理據。

And I think it's encouraged that the Health Canada has already approved us to start the trial in Canada. With the PE trial in terms of, yes, potential that we could get some data as soon as we have a cohort that's completed and we see some compelling data, we would look at potentially press releasing or getting that at a late-breaking conference.

而且我認為令人鼓舞的是，加拿大衛生部（Health Canada）已經核准我們在加拿大啟動試驗。至於子癲前症（PE）試驗方面，確實有可能一旦某個隊列完成、且我們看到一些具說服力的數據，我們就會考慮發布新聞稿，或在重大突破（late-breaking）的會議上公布。

And the last question that you had with regards to the outcomes of the interim analysis for the stroke program. First, we'll do a futility analysis. So if there's not a drug effect, we'll terminate. Otherwise, there'll be a resample size. And the resample size will be between 300 and 700 patients.

至於你最後一個問題，關於中風計畫的期中分析結果。首先我們會做無效性（futility）分析；如果看不到藥物效果，我們就會終止。否則，將會進行重新估算樣本數（resample size），樣本數會介於 300 到 700 名病患之間。

And we believe if we see a drug effect comparable to what we see from our Phase II, which is comparable to the data we've seen with the data with the human urinary form in China, and there's about 1 million patients either being treated with that form. We would look at completing the enrollment in the following quarter.

我們相信，如果我們看到的藥物效果可與我們第二期試驗所見相當——也與我們在中國看到的人類尿源型（human urinary form）數據相當，而該形式約有 100 萬名病患正在接受治療——那麼我們會考慮在下一個季度完成收案（enrollment）。

Helpful. Thank you so much.

很有幫助。非常感謝。

Thomas Flaten, Lake Street.

Thomas Flaten，Lake Street。

Hey, Rick, just following up on that last response, just to clarify, given that you've got 70-plus sites and 70% enrolled, if you -- when you said we're going to complete enrollment in the following quarter, do you mean the first quarter of '27 or the -- which quarter were you referring to on the full enrollment?

Rick，我想接續你剛才的回覆再確認一下：鑑於你們有 70 多個試驗中心且已收案 70%，當你說「我們會在下一個季度完成收案」時，你指的是 2027 年第一季，還是——你指的是哪一季完成全部收案？

Yes. So assuming that we have the interim analysis at the end of this year, then we would anticipate completing the enrollment the following quarter, so the Q1 of next year.

是的。假設我們在今年年底完成期中分析，那我們預期在下一個季度完成收案，也就是明年第一季（Q1）。

And does that assume an upsize in the total population? Because it seems to me it's only May. And by year-end, when the interim analysis reads out, you should be pretty close to full enrollment on the original study size, right?

那這是否假設總樣本數會上調？因為現在才 5 月。到年底期中分析出來時，照理你們應該已經非常接近原始研究規模的全數收案了，對吧？

We will be. So that after patient 200 is dosed, there'll be a 30 -- sorry, a 90-day window here for the primary endpoint and then another approximately four weeks for the interim analysis to occur. And during that approximately four months, we'll be continuing to enroll. So we'll be getting closer to the 300 patient number during that period of time.

我們會的。所以在第 200 位病患完成給藥後，主要終點會有 30——抱歉，是 90 天的觀察窗口，接著期中分析大約還需要另外約四週進行。在這大約四個月期間，我們會持續收案。因此在那段時間內，我們會更接近 300 名病患的數字。

Got it. And then just to clarify a prior response. So once you get the Part 1a expansion data out this quarter, there's -- is it reasonable to assume that you would start Part 1b and Part 2 in the third quarter? Or should we expect maybe a fourth quarter start on that?

了解。再澄清一下你先前的回覆：一旦你們在本季公布 Part 1a 擴增數據後，是否可以合理假設你們會在第三季啟動 Part 1b 和 Part 2？還是我們應該預期可能第四季才開始？

No, those should be starting here this summer. And so we're just -- we finalized the dosing that will be going into those cohorts. So we'll be doing three doses at 5, 10 and 15 micrograms per kg subcutaneous every three days until delivery. So those cohorts should be starting very soon.

不，這些應該會在今年夏天開始。我們已經確定將納入這些隊列的給藥劑量。我們會做三個劑量：每公斤 5、10 與 15 微克，皮下注射，每三天一次，直到分娩。因此這些隊列應該很快就會開始。

We had some -- we've now got our sites, Cape Town South Africa has had some challenges with some staffing and they've added some new staff. And so they've been very active recently in the Part 1a expansion study. So we feel very good that, that study will be enrolling soon.

我們有一些——目前我們的試驗中心中，南非開普敦在人力配置上遇到一些挑戰，已增補新員工。最近他們在 Part 1a 擴增研究上非常積極。因此我們對該研究很有信心，應該很快就會開始收案。

Chase Knickerbocker, Craig-Hallum Capital Group.

Chase Knickerbocker，Craig-Hallum Capital Group。

Good morning. Thanks for taking the questions. One for Scott. I appreciate your comments on forward R&D, but maybe just a little bit more color there. You said kind of modest increase. I would imagine kind of enrollment is still picking up on an absolute number for stroke. And then can you just give us an idea kind of what the magnitude of that increase you expect sequentially in stroke and then kind of the incremental costs you expect for PE through the year.

早安。謝謝讓我提問。有一題給 Scott。我很感謝你對前瞻研發（R&D）的評論，但能否再多提供一些細節？你提到是「小幅增加」。我想中風試驗的收案在絕對數量上應該仍在加速。你能否讓我們了解一下，你預期中風試驗的費用按季增加幅度大概是多少？以及今年內子癲前症（PE）預期的增量成本大概是多少？

Sure. Thanks, Chase. Yes, with respect to the stroke, modest increases. I mean the -- and you're correct, it's all going to be driven by the enrollment rates. And to some extent, it depends on whether those patients are enrolled in the US or Europe. US is probably the most expensive followed by UK, Canada and Europe.

當然。謝謝你，Chase。是的，關於中風試驗，小幅增加——你的判斷沒錯，主要會由收案速度驅動。在某種程度上，也取決於病患是在美國或歐洲收案。美國可能最昂貴，其次是英國、加拿大與歐洲。

And then with respect to the incremental cost for PE, there'll be -- well, we're still working on the estimates for the Phase II trial. The financial support we provide for the IST is very modest. It's an incredible bargain. So again, moderate -- modest to moderate increases, nothing order of magnitude change-wise.

至於子癲前症（PE）的增量成本——我們仍在估算第二期試驗的費用。我們對 IST 提供的財務支持非常有限，性價比非常高。所以同樣是中度——小到中度的增加，不會有數量級的變化。

Could you just define modest or moderate for us, if you don't mind? And then just one for Rick. Just as we think about the resample, should we kind of just expect to receive the number on the resample or anything else at that point that we'll be able to provide?

如果你不介意的話，能否幫我們定義一下「小幅」或「中度」？另外有一題給 Rick：當我們思考重新估算樣本數（resample）時，我們是否只會在那個時間點收到重新估算的數字，或還會有其他我們能提供的資訊？

Sure. For the interim analysis, we'll be providing an update on the expected timelines to complete the enrollments.

當然。針對期中分析，我們會更新完成收案的預期時間表。

Chase, it's hard to give a specific number because there's movement inside all the different expense categories. I mean I wouldn't expect it to go up more than 10% a quarter.

Chase，很難給出一個明確數字，因為各項費用類別內部都有變動。我是說，我不預期它會按季上升超過 10%。

Helpful. Thank you.

很有幫助。謝謝。

I will now hand today's call over to Rick Pauls for any closing remarks.

我現在把今天的電話會議交給 Rick Pauls，請他做結語。

All right. Well, thank you all for joining us today. We greatly appreciate your interest in DiaMedica and hope that you enjoy the rest of the day. This concludes our call today. Thank you.

好的。感謝各位今天加入。我們非常感謝大家對 DiaMedica 的關注，也希望各位今天剩下的時間過得愉快。今天的電話會議到此結束。謝謝。

Thank you for joining. You may now disconnect your lines.

感謝加入。您現在可以掛斷電話線。