DiaMedica Therapeutics Inc (DMAC) 2025 Q1 法說會逐字稿

Good morning, ladies and gentlemen, and welcome to the DiaMedica Therapeutics first quarter 2025 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. Before DiaMedica 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.

女士們、先生們，早安，歡迎參加 DiaMedica Therapeutics 2025 年第一季電話會議。今天電話會議結束後不久，您將可以在 DiaMedica 網站 www.Diamedica.com 的投資者關係部分上找到網路廣播的音訊記錄。在 DiaMedica 繼續發表評論之前，請注意該公司將在今天的電話會議上發表前瞻性陳述。這些聲明受風險和不確定性的影響，可能導致實際結果與這些聲明中預測的結果有重大差異。

More information, including factors that could cause actual results to differ from projected results, appears in the section entitled Cautionary Note regarding forward-looking statements. In the company's press release issued yesterday and under the heading Risk factors in the company's most recent annual report on Form 10K and most recent quarterly report, Form 10Q. DiaMedica's SEC filings are available on the SEC's website www.sec.gov and on its website Diamedica.com.

更多信息，包括可能導致實際結果與預測結果不同的因素，請參閱題為“有關前瞻性陳述的警告說明”的部分。在公司昨天發布的新聞稿中，以及公司最新的 10K 表年度報告和 10Q 表季度報告的「風險因素」標題下。DiaMedica 向美國證券交易委員會提交的文件可在美國證券交易委員會網站 www.sec.gov 及其網站 Diamedica.com 上查閱。

Please also note that any comments made on today's call speak only as of today, May 14, 2025 and may no longer be accurate at the time of any replay or transcript re-reading. DiaMedica disclaims any duty to update its forward-looking statements. Following the prepared remarks, the phone lines will be open for questions. I would now like to turn you over to your host for today's call, Mr. Rick Pauls, DiaMedica's President and Chief Executive Officer. Mr. Pauls.

另請注意，今天電話會議上發表的任何評論僅代表截至 2025 年 5 月 14 日的觀點，在重播或重讀記錄時可能不再準確。DiaMedica 不承擔更新其前瞻性聲明的任何義務。準備好的發言結束後，電話熱線將開放，接受提問。現在，我想將今天的電話會議主持人、DiaMedica 總裁兼執行長 Rick Pauls 先生交給您。保羅斯先生。

Thank you, operator. Hello, everyone, and welcome to our first quarter 2025 conference call. I am joined this morning by Scott Kellen, our Chief Financial Officer Dr. Lorianne Masuokais currently on short-term medical leave, and we hope she gets well soon. We're happy to be here today to update you on the progress on our two clinical development programs. It has only been a short interval since our last update. That's I'll keep my remarks brief. That said, I'm pleased to report that we continue to make substantial progress in both of our clinical development programs. I'll start with an update on a Preeclampsia program.

謝謝您，接線生。大家好，歡迎參加我們的 2025 年第一季電話會議。今天上午，我與 Scott Kellen 一起出席了會議，我們的財務長 Lorianne Masuokais 博士目前正在短期病假，我們希望她早日康復。我們很高興今天在這裡向您通報我們的兩個臨床開發項目的進展。距離我們上次更新僅過了很短的一段時間。因此我將簡短地發表我的言論。話雖如此，我很高興地報告，我們的兩個臨床開發項目都繼續取得實質進展。我首先會介紹先兆子癇計畫的最新進展。

Building upon the significant accomplishments of this program within a very short time frame as we discussed in March, we're pleased to be able to disclose that we believe Part 1A of our phase 2 investigative sponsored preeclampsia trial is very close to identifying a target dose to move forward with it in Part 1 B. Dose selection will be guided primarily a few key data points which we expect to be sharing in our upcoming preliminary top line results from the part 1A proof of concept portion of the trial. These key data points include 1, safety and tolerability, including results of a placental transfer analysis. 2. the amount of decrease in systolic and diastolic blood pressure levels and 3. changes in uterine and placental blood flow as assessed by the Doppler ultrasound measurement of the uterine artery pulsatility index. This measure is important as reductions in the pulsatility index may suggest decreased downstream resistance and improved uterine and placental blood flow, which could also be an indication of disease modifying.

正如我們在 3 月討論的那樣，基於該計劃在很短的時間內取得的重大成就，我們很高興地披露，我們相信我們第 2 階段調查贊助的先兆子癇試驗的第 1A 部分非常接近確定在第 1B 部分中繼續推進的目標劑量。劑量選擇將主要以幾個關鍵數據點為指導，我們預計將在即將發布的第 1A 部分概念驗證試驗的初步頂線結果中分享這些數據點。這些關鍵數據點包括：1、安全性和耐受性，包括胎盤轉移分析的結果。2.收縮壓和舒張壓下降的量，以及 3.透過多普勒超音波測量子宮動脈搏動指數來評估子宮和胎盤血流的變化。這項測量很重要，因為脈動指數的降低可能表明下游阻力降低以及子宮和胎盤血流改善，這也可能是疾病變化的徵兆。

Currently we expect to be in a position to release those preliminary topline results between the 2nd half of June and the 1st half of July. The final timing will be primarily dependent on the schedules at the outside laboratories running the various tests, including the pharmacodynamic biomarkers and the assay, which will be used to determine if DM 189 crosses the placental barrier. One additional update May is preeclampsia Awareness Month, and we will be sponsoring a preeclampsia key opinion leader call on May 28th at 8 a.m. Eastern.

目前，我們預計將在 6 月下半月至 7 月上半月之間發布這些初步結果。最終時間主要取決於外部實驗室進行各種測試的時間表，包括藥效動力學生物標記和檢測，這些測試將用於確定 DM 189 是否穿過胎盤屏障。5 月的另一個更新是先兆子癇宣傳月，我們將於 5 月 28 日東部時間上午 8 點贊助先兆子癇關鍵意見領袖電話會議。

Compared to other therapeutic areas like oncology, which have advanced more rapidly in recent years, the treatment of pregnancy complications remains outdated and is not well understood. No FDA approved treatments exist for preeclampsia despite the growing burden of this disease. To our knowledge, DM 19 is the only novel agent currently being studied in pregnant women with preeclampsia. With this KOL events, we will continue our work to educate investors, physicians, and other interested parties on preeclampsia as a disease and the current state of treatment.

與近年來發展更快的腫瘤學等其他治療領域相比，妊娠併發症的治療仍然過時且尚未得到很好的理解。儘管先兆子癇的盛行率日益增加，但目前尚無 FDA 核准的治療方法。據我們所知，DM 19 是目前正在研究的唯一針對子癇前症孕婦的新型藥物。透過此次 KOL 活動，我們將繼續致力於向投資者、醫生和其他相關方宣傳子癇前症以及目前的治療狀況。

With this background, we will also discuss the design of our current phase 2 trial of DM-189 in preeclampsia. Turning briefly to our stroke program, enrollment is moving ahead steadily, and we're pleased to announce that participant enrollment now is between the 20th and 25th percentile mark of patients enrolled for the interim analysis. Our next enrollment update will be at the 50th percentile mark.

在此背景下，我們也將討論我們目前針對子癇前症進行的 DM-189 第 2 階段試驗的設計。簡單談談我們的中風項目，招募工作正在穩步推進，我們很高興地宣布，現在的參與者招募人數處於中期分析招募患者的第 20 到第 25 個百分位之間。我們的下一次招生更新將位於第 50 個百分位。

We believe that our efforts over the past year to engage with sites to promote communications between the sites and to simplify study logistics have been important in driving the recent uptick in enrollment. Accordingly, we reiterated our guidance that the interim analysis on those 1st 200 participants will be completed in the first half of 2026.

我們相信，過去一年來我們與各站點合作、促進站點間溝通和簡化研究後勤工作的努力對於推動近期入學人數的上升起到了重要作用。因此，我們重申我們的指導意見，即對前 200 名參與者的中期分析將在 2026 年上半年完成。

I would also note for you that we have engaged an experienced stroke neurologist to support site engagement during Lorianne's leave in order to maintain our enrollment momentum in the Remedy II trial. This individual has spent over 10 years treating stroke patients at a major US research center and also has 5 years of recent biotech drug development experience. He has been doing a tremendous job connecting with and maintaining our relationships with sites and supporting our recent enrollment momentum. Now, I'd like to hand the call over to Scott Kellen to review this quarter's financial results.

我還要指出的是，我們聘請了一位經驗豐富的中風神經病學家，在 Lorianne 休假期間支持現場參與，以保持我們在 Remedy II 試驗中的招募勢頭。該人曾在美國一家大型研究中心治療中風患者超過 10 年，最近還擁有 5 年的生物技術藥物開發經驗。他為我們與各個站點建立聯繫並維護關係以及支持我們最近的招生勢頭做出了巨大的貢獻。現在，我想將電話交給 Scott Kellen 來回顧本季的財務表現。

Thanks, Rick, and good morning everyone. As the operator mentioned, we announced our first quarter, 2025 financial results and filed our quarterly report on Form 10Q yesterday after the markets closed. These documents are both available on either the DiaMedica or the SEC websites.

謝謝，里克，大家早安。正如營運商所提到的，我們在昨天市場收盤後公佈了 2025 年第一季的財務業績並提交了 10Q 表季度報告。這些文件均可在 DiaMedica 或 SEC 網站上找到。

As of March 31, 2025, we reported a total combined cash and investments of $37.3 million. Current liabilities of $4.7 million and working capital of $32.8 million. This compares to a total combined cash and investments of $44.1 million, $5.4 million in current liabilities, and $39.2 million in working capital as of December 31, 2024. The decreases in combined cash and investments and in working capital were due primarily to the net cash used to fund our operations.

截至 2025 年 3 月 31 日，我們報告的現金和投資總額為 3,730 萬美元。流動負債為 470 萬美元，營運資金為 3,280 萬美元。相較之下，截至 2024 年 12 月 31 日，現金和投資總額為 4,410 萬美元，流動負債為 540 萬美元，營運資金為 3,920 萬美元。現金和投資總額以及營運資本的減少主要是由於用於資助我們營運的淨現金所致。

The net cash used in operating activities for the first quarter of 2025 was $7.1 million compared to $6.7 million for the first quarter of 2024. The increase in cash used in operating activities resulted primarily from our increased net loss, partially offset by changes in operating assets abilities occurring during the current year period. We anticipate that our current cash and investments provides us a runway into Q3 of 2026.

2025 年第一季經營活動所用淨現金為 710 萬美元，而 2024 年第一季為 670 萬美元。經營活動所用現金的增加主要源自於淨虧損的增加，但被本年度期間經營資產能力的變動部分抵銷。我們預計，我們目前的現金和投資將為我們進入 2026 年第三季提供支撐。

Our research and development expenses increased to $5.7 million for the three months ended March 31, 2025, up from $3.7 million for the three months ended March 31, 2024. The increase was due primarily to cost increases resulting from the continuation of our remedy to clinical trial, including our global expansion, increased manufacturing development activity, and the expansion of our clinical team during 2024.

截至 2025 年 3 月 31 日的三個月，我們的研發費用從截至 2024 年 3 月 31 日的三個月的 370 萬美元增加至 570 萬美元。成長的主要原因是，我們繼續進行臨床試驗，包括我們的全球擴張、增加製造開發活動以及 2024 年期間臨床團隊的擴大，導致成本增加。

Now these increases were partially offset by cost reductions related to in use study work performed and completed in the prior year period. We expect that our R&D expenses will moderately increase in future periods relative to our recent prior periods as we continue our remedy to trial, including the global expansion and our continued expansion of our DM 199 clinical development program in preeclampsia.

現在，這些增加的部分被與去年同期執行和完成的使用中研究工作相關的成本減少所抵消。我們預計，隨著我們繼續試驗治療方法，包括全球擴張和繼續擴大子癇前症 DM 199 臨床開發計劃，未來期間我們的研發費用將相對於近期適度增加。

Our general and administrative expenses were $2.5 million and $2.1 million for the three months ended March 31, 2025, and 2024 respectively. This increase resulted primarily from additional non-cash share-based compensation expense recognized as a result of the approval of an extension of the post-termination exercise period for stock options held by a retiring member of our board of directors. We expect G&A expenses to remain steady in future periods as compared to recent prior periods.

截至 2025 年 3 月 31 日及 2024 年 3 月 31 日的三個月，我們的一般及行政費用分別為 250 萬美元及 210 萬美元。這一增長主要源於董事會批准延長退休成員持有的股票選擇權的離職後行使期而確認的額外非現金股份薪酬費用。我們預計，與近期相比，未來期間的一般及行政費用將保持穩定。

Our net other income was $443,000 for the three months ended March 31, 2025, compared to $597,000 for the three months ended in March 31, 2024. This decrease was driven by reduced interest income recognized during the current year period related to lower average marketable securities balances during the current year period as compared to the prior year period. With that, let me ask the operator to open the lines for questions.

截至 2025 年 3 月 31 日的三個月，我們的淨其他收入為 443,000 美元，而截至 2024 年 3 月 31 日的三個月，我們的淨其他收入為 597,000 美元。造成這一下降的原因是，與去年同期相比，今年期間的平均有價證券餘額較低，導致今年期間確認的利息收入減少。現在，請容許我請接線生開通問答專線。

Thank you so much, ladies and gentlemen. We'll now begin our question and answer session. Should you have a question, please press star, followed by one on your touchtone phone. You will hear a prompt that your hand has been raised. Should you wish to remove your hand from the queue, please press star, followed by 2. If you're using a speakerphone, please lift the handset before pressing any keys. One moment for your first question. And your first question comes from Thomas Flatton with Lake Street. Please go ahead.

非常感謝各位，女士們、先生們。我們現在開始問答環節。如果您有任何問題，請在按鍵電話上按星號，然後按 1。您將聽到提示，提示您已舉手。如果您希望從佇列中移除您的手，請按星號，然後按 2。如果您使用的是揚聲器，請在按任何按鍵之前拿起聽筒。請稍等片刻，回答您的第一個問題。您的第一個問題來自 Lake Street 的 Thomas Flatton。請繼續。

Good morning. I appreciate you taking the questions. Hey, Rick, just to clarify, the laboratory test results that seem to be the variable in terms of the readout between June and July, is that primarily the test for DM 199 crossing the placental barrier, so in the umbilical cord, or is there something else there that we should be aware of?

早安.感謝您回答這些問題。嘿，里克，只是想澄清一下，實驗室測試結果似乎是 6 月和 7 月之間讀數的變量，這主要是針對 DM 199 穿過胎盤屏障（即臍帶）的測試，還是還有其他我們應該注意的事項？

Yeah, Thomas, yeah, absolutely. So that's the main item is going to be the placental transfer. So we have an essay that we're just having finalized in terms of getting to lower limits of detection. And so it's just a question of time for them to run it. So we want to at least give a range today in terms of when we anticipate the results.

是的，托馬斯，是的，絕對是。因此，主要項目是胎盤移植。因此，我們有一篇關於降低檢測極限的論文剛剛完成。所以對他們來說，運行它只是時間問題。因此，我們今天至少想給出一個預期結果的範圍。

Makes sense. And then, I see you mentioned that you're expecting to start part 1 B in Q3. What are the triggers for part 2 and 3, so the expected management and the fetal growth restriction components of the study?

有道理。然後，我看到您提到您希望在第三季開始第 1 部分 B。第 2 部分和第 3 部分的觸發因素是什麼？預期的管理和研究中的胎兒生長限制部分是什麼？

So, I'll start off with the fetal growth restrictions. So, if we see dilation of the intrauterine arteries, our investigators are prepared to move ahead with that cohort, and then we'll have more to talk about the part two when we delight the results here in the coming weeks.

因此，我將從胎兒生長限制開始。因此，如果我們發現宮內動脈擴張，我們的研究人員就準備好繼續進行該群體的研究，然後當我們在未來幾週獲得結果時，我們將更多地討論第二部分。

Got it. Excellent I appreciate. You taking the questions. Thank you.

知道了。非常好，我很感激。你回答問題。謝謝。

Thanks, Thomas.

謝謝，托馬斯。

Your next question comes from Matthew Caufield with HC Wainwright. Please go ahead.

您的下一個問題來自 HC Wainwright 的 Matthew Caufield。請繼續。

Hi, good morning, guys. Thanks for taking our question. I was wondering if you could speak to the anticipated read through or any de-risking between the initial preeclampsia data and how that profile could translate to AIS development and the remedy to trial. Thanks again.

大家好，早安。感謝您回答我們的問題。我想知道您是否可以談談預期的解讀或初始先兆子癇數據之間的任何風險降低，以及該概況如何轉化為 AIS 開發和試驗治療。再次感謝。

Sure, I mean, I'll start off by saying that these are definitely two very unique indications, but I will add that a positive effect here in preeclampsia will just be another confirmation that this protein is active. And I would also mention around that we've previously talked about the fact that there are two forms of this protein in Asia that are being used. So, the formula protein isolated from human urine that today is treating close to a million patients per year for acute ischemic stroke, and then it's also a form of protein isolated from pig pancreas in both Japan and China. And we've been able to track down about 10 publications with that form of the protein to treat preeclampsia. So I think it'll just be very encouraged and you know that we have an active protein and what we're seeing in some of the validation and rationale for going into both of these indications is what we'll call the crude forms in Asia today.

當然，我的意思是，我首先要說的是，這絕對是兩個非常獨特的適應症，但我要補充一點，先兆子癇的積極作用只是再次證實了這種蛋白質是活躍的。我還想提一下，我們之前討論過，在亞洲，這種蛋白質有兩種形式正在使用。因此，從人類尿液中分離的配方蛋白如今每年用於治療近百萬急性缺血性中風患者，並且在日本和中國它也是一種從豬胰腺中分離的蛋白質。我們已經找到了大約 10 篇利用這種蛋白質治療子癇前症的出版物。所以我認為這將受到很大的鼓舞，你知道我們有一種活性蛋白質，我們在進入這兩種適應症的一些驗證和理由中看到的就是我們今天在亞洲所說的粗製形式。

Thanks a lot appreciate it guys.

非常感謝大家。

Thank you.

謝謝。

Your next question comes from Chase Knickerbocker with Craig Hallam. Please go ahead.

您的下一個問題來自 Craig Hallam 的 Chase Knickerbocker。請繼續。

Good morning. Thanks for taking the questions. Rick, just on stroke, be good to kind of get some incremental details on enrollment. I mean, maybe just kind of starting out with those high volume or potential high-volume centers, can you kind of give us an update on what percentage of kind of those high-volume accounts are now, at that 1 to 2 per month that you want to see?

早安.感謝您回答這些問題。里克，剛才打斷一下，很高興能得到一些關於招生的詳細資訊。我的意思是，也許只是從那些高容量或潛在的高容量中心開始，您能否向我們提供一下最新情況，即現在這些高容量帳戶的百分比是多少，您希望看到的是每月 1 到 2 個？

I would add that, as we had kind of talked on past calls, we really do, we really did think that there would be a small number of sites, in particularly in the US that would drive enrollment, and as we're starting to build some momentum, that's clearly what we're starting to see. So some of these high enrolling sites are seeing the 1 to 2 patients per site per month and so. We're working on building momentum and then really working hard on some of those other sites to expand the relationship here to encourage, but, I say currently we are above our plan here now and you know we're encouraged with the with the momentum that's being built.

我想補充一點，正如我們在過去的電話會議中談到的那樣，我們確實認為會有少數站點，特別是在美國，可以推動招生，而且隨著我們開始積累一些勢頭，這顯然是我們開始看到的。因此，一些高入院率的站點每個月會接待 1 到 2 名患者。我們正在努力積聚勢頭，然後在其他一些網站上努力工作，以擴大這裡的關係，但是，我說目前我們已經超出了我們的計劃，你知道我們對正在形成的勢頭感到鼓舞。

So maybe just an update on overall centers as well as, again, it's only been a couple of months here, but, we have we expanded that past 30 and then maybe on the geographic footprint of those centers that we started to see some international enrollment coming in.

因此，也許只是對整體中心進行更新，同樣，這才剛剛幾個月，但我們已經將其擴展到 30 個以上，然後也許在這些中心的地理覆蓋範圍內，我們開始看到一些國際招生。

Yeah, so we're currently in mid-30s, and keeping in mind that there are sites now that are not performing that we're shutting down and so we're really again focusing on the high-end rolling sites. We also have sites in Georgia that have been performing very well. And that's where that is the country of Georgia.

是的，所以我們目前處於 30 年代中期，並且請記住，現在有些站點沒有運行，我們正在關閉這些站點，因此我們再次將重點放在高端滾動站點上。我們在喬治亞州也有站點，表現非常良好。這就是格魯吉亞。

Yeah, I got it, and just kind of I guess summing all this up, first half 26 interim analysis, I think at least implies that, enrollment rates continue to pick up, and I mean you're seeing that trajectory in, recent weeks, recent months as far as that curve continuing to steepen.

是的，我明白了，我想總結一下，26 年上半年的中期分析至少表明，入學率繼續上升，我的意思是，你看到最近幾週、最近幾個月的軌跡表明曲線繼續變陡。

Yeah, absolutely, and from the last earnings call, we're definitely seeing an encouraging uptick.

是的，絕對如此，從上次財報電話會議來看，我們確實看到了令人鼓舞的成長動能。

Got it, that's it for me. Thanks.

明白了，對我來說就這樣了。謝謝。

Great, thanks, Chase.

太好了，謝謝你，Chase。

Your next question comes from Thomas Flatten with Lake Street. Please go ahead.

您的下一個問題來自 Lake Street 的 Thomas Flatten。請繼續。

Yeah, hey, thanks for taking another question. Just back to preeclampsia real quick, the part 2 and 3, those are, those studies will be primarily based out of South Africa, or are you thinking that there's going to be a US component to those which would necessitate ID filing?

是的，嘿，感謝您回答另一個問題。回到子癇前症的話題，第 2 部分和第 3 部分，這些研究主要以南非為基地，或者您是否認為其中會有一個美國部分，需要進行身分證申報？

So that part 2 and part 3 are still part of the same protocol, and so our collaborators will not need to go back for regulatory clearance.

因此第 2 部分和第 3 部分仍然是同一協議的一部分，我們的合作者無需回去尋求監管部門的批准。

And at some point, will you expand the study and if so, when into the US?

在某個時候，您是否會擴大這項研究？如果會，什麼時候擴展到美國？

We do plan in the future to expand this to the US and global, and you know we'll have more to share at a later date. Right now, the focus is getting the part 1A and then moving into the part 1B as well as parts2 and then 3 hopefully.

我們確實計劃在未來將其擴展到美國和全球，您知道我們稍後會分享更多資訊。現在，重點是獲得第 1A 部分，然後進入第 1B 部分以及第 2 部分，然後希望是第 3 部分。

Got it. I appreciate it. Thank you.

知道了。我很感激。謝謝。

Yes, thanks, Thomas.

是的，謝謝，托馬斯。

Thank you. There are no further questions at this time. I would like to turn the call back to Mr. Rick Pauls.

謝謝。目前沒有其他問題。我想把電話轉回給 Rick Pauls 先生。

Alright, in closing, we're very encouraged by our steady progress and clear momentum across both the preeclampsia and stroke programs. We look forward to sharing upcoming key milestones, including the top line results from our preeclampsia approve a concept trial and the interim analysis from our stroke program. We thank our dedicated team. Investigators and importantly our patients and their families for the continued trust and commitment. Please also mark your calendars from May 28th at 8 a.m. Eastern time for our preeclampsia KOL event. We'll be sending out the call in details via press release early next week. As always, we appreciate the ongoing support of our shareholders and look forward to updating you further in the months ahead. Thank you again for joining our call today. This concludes our call.

好的，最後，我們對先兆子癇和中風計畫的穩定進展和明顯勢頭感到非常鼓舞。我們期待分享即將到來的關鍵里程碑，包括先兆子癇概念試驗的頂線結果和中風項目的中期分析。我們感謝我們敬業的團隊。研究人員以及更重要的是我們的患者和他們的家人對我們持續的信任和承諾。也請在日曆上標記 5 月 28 日東部時間上午 8 點，以參加我們的子癇前症 KOL 活動。我們將於下周初透過新聞稿發布有關此次電話會議的詳細資訊。像往常一樣，我們感謝股東的持續支持，並期待在未來幾個月向您提供進一步的更新資訊。再次感謝您今天參加我們的電話會議。我們的通話到此結束。

Ladies and gentlemen, you may now disconnect.

女士們、先生們，現在可以斷開連接了。