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Yahoo
22-05-2025
- Business
- Yahoo
DiaMedica Therapeutics to Present at Jefferies Global Healthcare Conference 2025
MINNEAPOLIS, May 22, 2025--(BUSINESS WIRE)--DiaMedica Therapeutics Inc. (Nasdaq: DMAC), a clinical-stage biopharmaceutical company focused on developing novel treatments for preeclampsia and acute ischemic stroke, today announced that Rick Pauls, President and CEO, and Dave Wambeke, Chief Business Officer, will present at the upcoming Jefferies Global Healthcare Conference, being held in New York City, NY, June 3 – 5, 2025. Management will be available for one-on-one meetings with investors to discuss the company's strategy, recent developments and future outlook in greater detail. Presentation Details: Date & Time: June 4, 2025, 12:50 PM Eastern Time Location: New York City, NY About DM199 (rinvecalinase alfa) DM199 (rinvecalinase alfa) is a recombinant form of human tissue kallikrein-1 (rhKLK1) in clinical development for preeclampsia and acute ischemic stroke. KLK1 is a serine protease enzyme that plays an important role in the regulation of diverse physiological processes via a molecular mechanism that increases production of nitric oxide, prostacyclin and endothelium-derived hyperpolarizing factors. In the treatment of preeclampsia, DM199 is intended to lower blood pressure, enhance endothelial health and improve perfusion to maternal organs and the placenta. In the treatment of AIS, DM199 is intended to enhance blood flow and boost neuronal survival in the ischemic penumbra by dilating arterioles surrounding the site of the vascular occlusion and inhibition of apoptosis (neuronal cell death) while also facilitating neuronal remodeling through the promotion of angiogenesis. About DiaMedica Therapeutics Inc. DiaMedica Therapeutics Inc. is a clinical stage biopharmaceutical company committed to improving the lives of people suffering from preeclampsia and acute ischemic stroke. DiaMedica's lead candidate, DM199, is the first pharmaceutically active recombinant (synthetic) form of the KLK1 protein, an established therapeutic modality in Asia for the treatment of acute ischemic stroke, preeclampsia and other vascular diseases. For more information visit the Company's website at View source version on Contacts Scott KellenChief Financial OfficerPhone: (763) 496-5118skellen@ For Investor Inquiries:Mike MoyerManaging Director, LifeSci Advisors, LLCmmoyer@ Sign in to access your portfolio
Associated Press
22-05-2025
- Business
- Associated Press
DiaMedica Therapeutics to Present at Jefferies Global Healthcare Conference 2025
MINNEAPOLIS--(BUSINESS WIRE)--May 22, 2025-- DiaMedica Therapeutics Inc. (Nasdaq: DMAC), a clinical-stage biopharmaceutical company focused on developing novel treatments for preeclampsia and acute ischemic stroke, today announced that Rick Pauls, President and CEO, and Dave Wambeke, Chief Business Officer, will present at the upcoming Jefferies Global Healthcare Conference, being held in New York City, NY, June 3 – 5, 2025. Management will be available for one-on-one meetings with investors to discuss the company's strategy, recent developments and future outlook in greater detail. Presentation Details: Date & Time: June 4, 2025, 12:50 PM Eastern Time Location: New York City, NY About DM199 (rinvecalinase alfa) DM199 (rinvecalinase alfa) is a recombinant form of human tissue kallikrein-1 (rhKLK1) in clinical development for preeclampsia and acute ischemic stroke. KLK1 is a serine protease enzyme that plays an important role in the regulation of diverse physiological processes via a molecular mechanism that increases production of nitric oxide, prostacyclin and endothelium-derived hyperpolarizing factors. In the treatment of preeclampsia, DM199 is intended to lower blood pressure, enhance endothelial health and improve perfusion to maternal organs and the placenta. In the treatment of AIS, DM199 is intended to enhance blood flow and boost neuronal survival in the ischemic penumbra by dilating arterioles surrounding the site of the vascular occlusion and inhibition of apoptosis (neuronal cell death) while also facilitating neuronal remodeling through the promotion of angiogenesis. About DiaMedica Therapeutics Inc. DiaMedica Therapeutics Inc. is a clinical stage biopharmaceutical company committed to improving the lives of people suffering from preeclampsia and acute ischemic stroke. DiaMedica's lead candidate, DM199, is the first pharmaceutically active recombinant (synthetic) form of the KLK1 protein, an established therapeutic modality in Asia for the treatment of acute ischemic stroke, preeclampsia and other vascular diseases. For more information visit the Company's website at View source version on CONTACT: Scott Kellen Chief Financial Officer Phone: (763) 496-5118 [email protected] Investor Inquiries: Mike Moyer Managing Director, LifeSci Advisors, LLC [email protected] KEYWORD: UNITED STATES NORTH AMERICA MINNESOTA NEW YORK INDUSTRY KEYWORD: SCIENCE OTHER SCIENCE BIOTECHNOLOGY RESEARCH PHARMACEUTICAL HEALTH FDA CLINICAL TRIALS SOURCE: DiaMedica Therapeutics Inc. Copyright Business Wire 2025. PUB: 05/22/2025 08:30 AM/DISC: 05/22/2025 08:29 AM
Yahoo
15-05-2025
- Business
- Yahoo
Q1 2025 DiaMedica Therapeutics Inc Earnings Call
Operator 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 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. 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 and on its website 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. 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. 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. 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. 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. 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. 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. 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. 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. 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. 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. 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. 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. 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. 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. Operator 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. 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? 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. 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? 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. Got it. Excellent I appreciate. You taking the questions. Thank you. Thanks, Thomas. Operator Your next question comes from Matthew Caufield with HC Wainwright. Please go ahead. 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. 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. Thanks a lot appreciate it guys. Thank you. Operator Your next question comes from Chase Knickerbocker with Craig Hallam. Please go ahead. 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? 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. 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. 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. 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. Yeah, absolutely, and from the last earnings call, we're definitely seeing an encouraging uptick. Got it, that's it for me. Thanks. Great, thanks, Chase. Operator Your next question comes from Thomas Flatten with Lake Street. Please go ahead. 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? 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. And at some point, will you expand the study and if so, when into the US? 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. Got it. I appreciate it. Thank you. Yes, thanks, Thomas. Operator Thank you. There are no further questions at this time. I would like to turn the call back to Mr. Rick Pauls. 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. Operator Ladies and gentlemen, you may now disconnect. Error in retrieving data Sign in to access your portfolio Error in retrieving data Error in retrieving data Error in retrieving data Error in retrieving data
Business Wire
13-05-2025
- Business
- Business Wire
DiaMedica Therapeutics Reports First Quarter 2025 Financial Results And Provides Business Highlights
MINNEAPOLIS--(BUSINESS WIRE)--DiaMedica Therapeutics Inc. (Nasdaq: DMAC), a clinical-stage biopharmaceutical company focused on developing novel treatments for acute ischemic stroke and preeclampsia, today provided a business update and financial results for the quarter ended March 31, 2025. Management will host a conference call Wednesday, May 14, 2025, at 8:00 AM Eastern Time / 7:00 AM Central Time to discuss its business update and first quarter 2025 financial results. Preeclampsia Phase 2 Clinical Developments Parts 1A and B Dosing in the Phase 2 Part 1A trial of DM199 for preeclampsia (DM199 For Pregnancy Complications trial – PACTR202404895013782) continues as planned and is nearing the identification of the most clinically-relevant therapeutic dose-level for use in the Part 1B expansion phase of the trial. Preliminary topline safety and efficacy results from Part 1A of the trial are anticipated between the second half of June and the first half of July, depending on turnaround time for laboratory test results. 'With the upcoming release of preliminary topline safety and efficacy results from Part 1A of the Phase 2 preeclampsia study, DiaMedica is entering what we believe will be an exciting phase in the history of our company,' said Rick Pauls, President and CEO of DiaMedica Therapeutics. 'Building on this data, we believe DM199 has an opportunity to become a treatment option for preeclampsia, which is among the most underserved conditions in medicine today with no approved therapeutics.' The Company will be hosting a virtual key opinion leader (KOL) event on May 28, 2025 at 8:00 AM ET to discuss the current treatment landscape for preeclampsia and the clinical trial design and endpoints of the DM199 Phase 2 preeclampsia study. More details to follow in the coming week. Acute Ischemic Stroke (AIS) ReMEDy2 Phase 2/3 Clinical Developments Enrollment in the Company's Phase 2/3 ReMEDy2 (the ReMEDy2 trial – NCT065216) trial is progressing as planned as discussed at the Company's last quarterly business update. DiaMedica reiterates its guidance for the interim analysis on the first 200 patients to be completed in the first half of 2026. Financial Results Highlights for the Quarter Ended March 31, 2025 Cash Position and Runway – Cash, cash equivalents and short-term investments were $37.3 million as of March 31, 2025, compared to $44.1 million as of December 31, 2024. Based on its current plans, the Company anticipates its current cash, cash equivalents and short-term investments will enable the Company to fund its planned clinical studies and support corporate operations into the third quarter of 2026. Cash Flows - Net cash used in operating activities for the quarter ended March 31, 2025 was $7.1 million compared to $6.7 million for the same period in 2024. The increase in cash used in operating activities resulted primarily from the increased net loss in the quarter ended March 31, 2025 as compared with the prior year period. Research and Development (R&D) – R&D expenses were $5.7 million and $3.7 million for the quarters ended March 31, 2025 and 2024, respectively. The increase was due primarily to cost increases resulting from the continuation of the ReMEDy2 clinical trial, including its global expansion; increased manufacturing development activity; and the expansion of the clinical team during 2024. These increases were partially offset by cost reductions related to in-use study work performed and completed in the prior year period. General and Administrative (G&A) – G&A expenses were $2.5 million and $2.1 million for the quarters ended March 31, 2025 and 2024, respectively. This increase resulted primarily from additional non-cash share-based compensation. Net Loss - Net loss was $7.7 million, or $0.18 loss per share, for the quarter ended March 31, 2025, compared to $5.2 million, or $0.14 loss per share, for the quarter ended March 31, 2024. Conference Call and Webcast Information DiaMedica Management will host a conference call and webcast to discuss its business update and first quarter 2025 financial results on Wednesday, May 14, 2025, at 8:00 AM Eastern Time / 7:00 AM Central Time: Interested parties may access the conference call by dialing in or listening to the simultaneous webcast. Listeners should log on to the website or dial in 15 minutes prior to the call. The webcast will remain available for play back on the Company's website, under investor relations - events and presentations, following the earnings call and for 12 months thereafter. A telephonic replay of the conference call will be available until May 21, 2025, by dialing (888) 660-6345 (US Toll Free) and entering the replay passcode: 93262#. About the Phase 2 Trial of DM199 for Preeclampsia Preeclampsia (PE) is a serious pregnancy disorder that typically develops after the 20th week of gestation, characterized by high blood pressure and damage to organ systems, often the kidneys and liver. Affecting up to 8% of pregnancies worldwide, preeclampsia can pose significant risks to both the mother and baby, including risk of stroke, placental abruption, progression to eclampsia, premature delivery and death. Currently there are no approved pharmacologic treatments of preeclampsia in any marketed territory in the world and represents a critical unmet medical need. This Phase 2 program is an investigator-sponsored, single center trial evaluating DM199 in preeclampsia that will enroll up to 90 women with preeclampsia and 30 women with fetal growth restriction. This trial is being conducted at the Tygerberg Hospital, Cape Town, South Africa (SA), under the direction of Catherine Cluver, MD, PhD, Professor of Maternal/Fetal Medicine, Stellenbosch University, Stellenbosch, SA, in collaboration with DiaMedica. The Phase 2 trial consists of three parts: Part 1 consists of: Part 1A, an open-label, single-arm, dose-escalation and proof-of-concept study in up to 30 women with preeclampsia requiring delivery within 72 hours. The objective of Part 1A is to identify a clinically-relevant therapeutic dose; Part 1B is an open-label, single-arm, single-dose level, safety, tolerability to then treat an additional up to 30 women with preeclampsia requiring delivery within 72 hours at the dose-level determined in Part 1A. Part 2 of the program is an open-label, single-arm, single-dose level, safety and tolerability study treating up to 30 women with preeclampsia undergoing expectant management. Part 3 of the program is an open-label, single-arm, single-dose level, safety and tolerability study treating up to 30 women with preeclampsia and fetal growth restriction. The overall data from the open-label Phase 2 program will enable further detailed discussions with the United States Food and Drug Administration and European regulatory authorities on the appropriate development pathway for market approval. About the Phase 2/3 ReMEDy2 Trial of DM199 for Acute Ischemic Stroke The ReMEDy2 trial is an adaptive design, randomized, double-blind, placebo-controlled trial studying the use of the Company's product candidate, DM199, to treat acute ischemic stroke patients that present within 4.5 to 24 hours of stroke onset. Currently there are no approved pharmacologic agents to treat acute ischemic stroke in the 4.5 to 24 hour timeframe and represents a critical unmet medical need. The trial is intended to enroll approximately 300 patients at up to 100 sites globally. The final sample size will be determined based upon the results of an interim analysis of 200 participants and, if not stopped for futility, may range between 300 and 728 patients, according to a pre-determined statistical plan. Patients enrolled in the trial will be treated for three weeks with either DM199 or placebo, beginning within 24 hours of the onset of AIS symptoms, with the final follow-up at 90 days. The trial excludes patients who received mechanical thrombectomy (MT) or participants with large vessel occlusions in the intracranial carotid artery or the M1 segment for the middle cerebral, vertebral or basilary arteries or those that are otherwise eligible for MT. Participants treated with tissue plasminogen activator (tPA) or tenecteplase (TNK), (thrombolytic agents) intended to dissolve blood clots, are eligible for participation if they continue to experience a persistent neurological deficit after receiving thrombolytic treatment and meet all other trial criteria. DiaMedica believes that the ReMEDy2 trial has the potential to serve as a pivotal registration study of DM199 in this patient population. About DM199 DM199 (rinvecalinase alfa) is a recombinant form of human tissue kallikrein-1 (rhKLK1) in clinical development for preeclampsia and acute ischemic stroke. KLK1 is a serine protease enzyme that plays an important role in the regulation of diverse physiological processes via a molecular mechanism that increases production of nitric oxide, prostacyclin and endothelium-derived hyperpolarizing factors. In the treatment of preeclampsia, DM199 is intended to lower blood pressure, enhance endothelial health and improve perfusion to maternal organs and the placenta. In the treatment of AIS, DM199 is intended to enhance blood flow and boost neuronal survival in the ischemic penumbra by dilating arterioles surrounding the site of the vascular occlusion and inhibition of apoptosis (neuronal cell death) while also facilitating neuronal remodeling through the promotion of angiogenesis. About DiaMedica Therapeutics Inc. DiaMedica Therapeutics Inc. is a clinical stage biopharmaceutical company committed to improving the lives of people suffering from preeclampsia and acute ischemic stroke. DiaMedica's lead candidate, DM199, is the first pharmaceutically active recombinant (synthetic) form of the KLK1 protein, an established therapeutic modality in Asia for the treatment of preeclampsia, acute ischemic stroke and other vascular diseases. For more information visit the Company's website at Cautionary Note Regarding Forward-Looking Statements This press release contains forward-looking statements within the meaning of the U.S. Private Securities Litigation Reform Act of 1995 and forward-looking information that are based on the beliefs of management and reflect management's current expectations. When used in this press release, the words 'anticipates,' 'believes,' 'continue,' 'could,' 'estimates,' 'expects,' 'intends,' 'may,' 'plans,' 'potential,' 'should,' or 'will,' the negative of these words or such variations thereon or comparable terminology and the use of future dates are intended to identify forward-looking statements and information. The forward-looking statements and information in this press release include statements regarding the Company's expectations regarding the timing for preliminary topline safety and efficacy data from Part 1A of the preeclampsia Phase 2 investigator-sponsored trial; continued ReMEDy2 trial enrollment and the timing of the interim analysis on the first 200 participants in the first half of 2026; anticipated clinical benefits and success of DM199 for the treatment of preeclampsia and acute ischemic stroke; future R&D and G&A expenses and the Company's cash runway into the third quarter of 2026. Such statements and information reflect management's current view and DiaMedica undertakes no obligation to update or revise any of these statements or information. By their nature, forward-looking statements involve known and unknown risks, uncertainties and other factors which may cause actual results, performance or achievements, or other future events, to be materially different from any future results, performance or achievements expressed or implied by such forward-looking statements. Applicable risks and uncertainties include, among others, risks and uncertainties relating to the timing of and topline safety and efficacy data from Part 1A of the Phase 2 trial for preeclampsia and risks and uncertainties relating to the clinical expansion into preeclampsia and that trial; the timing of ReMEDy2 trial enrollment, regulatory applications and related filing and approval timelines; the possibility that enrollment in the ReMEDy2 trial will not continue to increase as anticipated; the possibility of additional future adverse events associated with or unfavorable results from the ReMEDy2 trial; the possibility of unfavorable results from DiaMedica's other ongoing or future clinical trials of DM199; the risk that existing preclinical and clinical data may not be predictive of the results of ongoing or later clinical trials; DiaMedica's plans to develop, obtain regulatory approval for and commercialize its DM199 product candidate for the treatment of preeclampsia and acute ischemic stroke and its expectations regarding the benefits of DM199; DiaMedica's ability to conduct successful clinical testing of DM199 and within its anticipated parameters, site activations, enrollment numbers, costs and timeframes; the adaptive design of the ReMEDy2 trial and the possibility that the targeted enrollment and other aspects of the trial could change depending upon certain factors, including additional input from the FDA and the blinded interim analysis; the perceived benefits of DM199 over existing treatment options; the potential direct or indirect impact of hospital and medical facility staffing shortages, increased tariffs and worldwide global supply chain shortages on DiaMedica's business and clinical trials, including its ability to meet its site activation and enrollment goals; DiaMedica's reliance on collaboration with third parties to conduct clinical trials; DiaMedica's ability to continue to obtain funding for its operations, including funding necessary to complete current and planned clinical trials and obtain regulatory approvals for DM199 for preeclampsia and acute ischemic stroke and the risks identified under the heading 'Risk Factors' in DiaMedica's annual report on Form 10-K for the fiscal year ended December 31, 2024 filed with the U.S. Securities and Exchange Commission (SEC) and subsequent SEC reports. The forward-looking information contained in this press release represents the expectations of DiaMedica as of the date of this press release and, accordingly, is subject to change after such date. Readers should not place undue importance on forward-looking information and should not rely upon this information as of any other date. While DiaMedica may elect to, it does not undertake to update this information at any particular time except as required in accordance with applicable laws. DiaMedica Therapeutics Inc. Condensed Consolidated Balance Sheets (In thousands, except share amounts) March 31, 2025 December 31, 2024 (unaudited) ASSETS Current assets: Cash and cash equivalents $ 2,589 $ 3,025 Marketable securities 33,731 41,122 Prepaid expenses and other assets 649 227 Amounts receivable 253 236 Deposits 200 — Total current assets 37,422 44,610 Non-current assets: Marketable securities 1,000 — Operating lease right-of-use asset, net 259 279 Property and equipment, net 149 148 Deposits — 1,308 Total non-current assets 1,408 1,735 Total assets $ 38,830 $ 46,345 LIABILITIES AND EQUITY Current liabilities: Accounts payable $ 1,507 $ 940 Accrued liabilities 3,053 4,347 Operating lease obligation 93 90 Finance lease obligation 12 13 Total current liabilities 4,665 5,390 Non-current liabilities: Operating lease obligation 201 225 Finance lease obligation 10 12 Total non-current liabilities 211 237 Shareholders' equity: Common shares, no par value; unlimited authorized; 42,859,465 and 42,818,660 shares issued and outstanding, as of March 31, 2025 and December 31, 2024, respectively — — Paid-in capital 181,658 180,697 Accumulated other comprehensive income 5 23 Accumulated deficit (147,709 ) (140,002 ) Total shareholders' equity 33,954 40,718 Total liabilities and shareholders' equity $ 38,830 $ 46,345 Expand DiaMedica Therapeutics Inc. Condensed Consolidated Statements of Cash Flows (In thousands) (Unaudited) Three Months Ended March 31, 2025 2024 Cash flows from operating activities: Net loss $ (7,707 ) $ (5,151 ) Adjustments to reconcile net loss to net cash used in operating activities: Share-based compensation 867 488 Amortization of discount on marketable securities (261 ) (329 ) Non-cash lease expense 20 18 Depreciation 11 8 Changes in operating assets and liabilities: Amounts receivable (17 ) (30 ) Prepaid expenses and other assets (422 ) (158 ) Deposits 1,108 (1,308 ) Accounts payable 567 (210 ) Accrued liabilities (1,315 ) 19 Net cash used in operating activities (7,149 ) (6,653 ) Cash flows from investing activities: Purchase of marketable securities (6,866 ) (9,783 ) Maturities of marketable securities 13,500 14,000 Purchases of property and equipment (12 ) (9 ) Net cash provided by investing activities 6,622 4,208 Cash flows from financing activities: Proceeds from the exercise of stock options 94 — Principal payments on finance lease obligation (3 ) (1 ) Net cash provided by (used in) financing activities 91 (1 ) Net decrease in cash and cash equivalents (436 ) (2,446 ) Cash and cash equivalents at beginning of period 3,025 4,543 Cash and cash equivalents at end of period $ 2,589 $ 2,097 Supplemental disclosure of non-cash transactions: Cash paid for income taxes $ 6 $ 7 Expand
