Q3 2025 DiaMedica Therapeutics Inc Earnings Call

Speaker #3: Based on historical enrollment We data . believe this primarily is due to changes in stroke referral patterns by the such technologies Viz.ai and in the tele of as when patients present to smaller use hospitals and are not eligible for mechanical adoption of thrombectomy .

Speaker #3: currently more likely than in the They are remain at those hospitals rather than get transferred to the larger comprehensive stroke centers that typically serve as our research sites .

Speaker #3: and implement strategies to develop offset these support our clinical sites . challenges and Based on this updated our recently remedy to enrollment preparing to rates forecast from our enrollment clinical trial sites in lieu historical rates we originally used said , .

Speaker #3: a lot of of the enthusiasm among the are investigators who highly motivated to find additional options That high for this unmet need . medical continue treatment to make steady progress with enrollment of .

Speaker #3: today , our approaching As enrollment our 50% of our target for analysis that interim includes a sample size Re-estimation . We now the expect interim analysis based on the first 200 patients to be in the second completed half 2026 .

Speaker #3: of reminder , after reviewing data from the participants safety study , first 50 the in this independent Safety Data Board Monitoring safety concerns and unanimously recommended enrollment that continue without modification .

Speaker #2: Julie . Thanks , I would like to now Ascot to review financial quarter the .

Speaker #2: Thanks . Rick , and

Speaker #4: . everyone As of September 30th , cash cash 2025 , our short equivalents and term $55.3 million . This were $30 million as of June 30th , 2025 , and 44.1 million as of our year prior end .

Speaker #4: Our current cash net includes the proceeds from our July private placement . We feel confident that our current cash position will fund our planned studies corporate operations second half into the of 2027 .

Speaker #4: We used $21.3 million of net cash in operating activities for the nine months ended September 30th , 2025 , compared to $15.6 million for the same period in 2024 .

Speaker #4: increase is This primarily a result of the increase in net loss in the first nine months of 2025 , compared to the prior year period , partially by changes in assets and offset liabilities during the current year .

Speaker #4: R&D period Our expenses were 6.4 million and operating 17.9 million for the three and nine month periods ending September 30th , 2025 . This was an increase from 5,000,012.6 million for the same time prior in the .

Speaker #4: periods year were due Both primarily to increases , including its cost resulting from the global progress of the progress with increases the expansion phase two investigator sponsored trial in continued preeclampsia and the expansion of our clinical team during the prior current and year periods .

Speaker #4: These increases were partially offset by cost reductions related to manufacturing process development work performed and completed in the prior year periods. Our general and administrative expenses were $2.6 million and $7.3 million for the three and nine months ending September 30, 2025.

Speaker #4: These expenses increased compared to the same time in 2020 . periods which 1.9 million were and 5.7 million , respectively . The increases in both periods resulted primarily from increased non-cash share based compensation and personnel increased costs incurred conjunction in expanding our team .

Speaker #4: investor Increases in relations , patent and professional fees also to the contributed both periods increases in . Overall , our net losses were 8.6 million and 24.0 million for the three and nine month period ending September 30th , These 2025 .

Speaker #4: are higher than the 6.3 million and the same 16.5 million reported during period For . Now , let me call turn the back over to Rick

Speaker #4: .

Speaker #2: you . We'd like to now open the call for Scott . questions . Thank Operator . please If you could introduce the first analyst .

Speaker #1: you . Your first question comes Thank from Stacy Kouwe with TD . Cowan . Your line is open .

Speaker #5: Hey . Good Thanks so morning . much for taking our questions . And congrats on the progress . So as first , we go a little bigger picture , maybe as we from the minutes Pre-ind FDA meeting , you talk await the about the can work that you all are doing with community and the pre-eclampsia clinical trials to increase awareness of what you've seen so far with the Dm1 99 proof of concept ?

Speaker #5: it comes to Specifically , when US clinical development . Maybe also talk about the key factors you're now for considering right trial sites .

Speaker #5: So that's the first question . And then the second , as it relates to the protocol , maybe can you go into a little bit more detail what you all are thinking , maybe talk a little about bit more the amendments doses the and outcomes that you all are seeing so far .

Speaker #5: Just help us understand that piece . Thank you so . much

Speaker #2: Sure . Great , great . Stacy . So starting off with the Col . So we've been doing extensive reach out quite with Kols really across the US and also , you know , basically for that globally matter .

Speaker #2: feedback that we've been getting has been very encouraging . There hasn't been a drug in development for preeclampsia a number for years . And I of think first off , the getting feedback we're is , you know , the fact that the crossing the not drug is placental barrier is just a very safety critical profile .

Speaker #2: And just to and immediate drops in blood pressure seeing those and the fact that we're seeing that very encouraging consistently amongst pretty much every patient .

Speaker #2: And then , you know , I think the upside is it's also encouraging . But early still know , the is , you dilation of the arteries intra uterine .

Speaker #2: And so if this can consist into later stage studies , you know , I think this is a clear sign of being disease modifying with protocol regards to the at .

Speaker #2: So first for the part one B , what we're looking at doing is IV only . And IV until delivery with the ability of the physicians to adjust the the dosing as as needed .

Speaker #2: And so being able to dial in the the blood pressure to where it needs to be ahead of delivery . And the part two , then for we're still working on on some that adjustments on .

Speaker #2: Right now we're looking at likely using cohort ten from recently completed part one a of the study in part cohort ten , we see very consistent and very clear drops in blood pressure .

Speaker #2: As we've seen, you from cohort 6 to 9.

Speaker #5: Understood . Thank you so much .

Speaker #2: Thanks , Stacy

Speaker #1: next question comes from

Speaker #1: with Lake Street Capital Markets . Your line is open . .

Speaker #6: morning . for taking questions . Thanks follow up Hey . Good on Just a the part one B you kind of wedged in this 12 patient expansion cohort from from part one a was that intended to kind of supplement what you had originally intended to do with part one B where you were going to do basically a dose I'm trying expansion cohort ?

Speaker #6: to understand the purpose of that 12 patient cohort , given the changes you're contemplating for part one .

Speaker #2: D yeah , that's it . exactly So this , this , this cohort done is at at expansion , we've cohort ten . So that's the highest dose we've gone to .

Speaker #2: And so I'd call this kind of an additional work that really would replace what was previously planned for the part one B . then when the part one B now will be , And will be IV only .

Speaker #6: Got And then as you ramp up towards a phase two study here in the US , what is the What data are you waiting it .

Speaker #6: Kluver you before initiate the study here actually in the US , is there trigger ? particular you're waiting for ?

Speaker #2: been analyzing the No , we've data that we've received up to date . We'll be continuing to dosing more patients before that study gets initiated .

Speaker #2: And , you know , not just the , you know , the efficacy and the safety data , you know , the PK data is also very important that we've been analyzing as well .

Speaker #2: So we but , feel we have the data that we need to proceed . But of course , you know , we get any additional data way that could further along the help us to refine the that protocol as needed .

Speaker #2: Right now , the plan is for the that phase two would be to up approximately 30 participants for the for the US study .

Speaker #6: Excellent . Thanks , Rick .

Speaker #2: Thanks , Thomas .

Speaker #1: The next question comes from Chase Knickerbocker with Craig-hallum . Your line is open .

Speaker #7: Good morning . Thanks for the questions . Maybe just first , Rick , any more specifics you'd be willing to give on what you saw in cohort ten ?

Speaker #7: That kind of led to those additional 12 patients , and then that , you know , comment on , you know , potentially that being the the dose we're going to take into part two , just any additional you'd be willing detail to give on what you've seen in the patients you've dosed in that far cohort so

Speaker #7: ?

Speaker #2: think we're Yeah , what we're what we're seeing . Chase is just very clear and immediate drop in blood pressure . You know , some of these patients .

Speaker #2: In cohort ten and even , you the those that are , you know , in the 6 to 9 , you know , these patients are all resistant know , in hypertension .

Speaker #2: They've been on maximum tolerable alpha beta blockers , calcium blockers channel . And their refractory . They're not seeing any improvement . You know some of these patients are coming in .

Speaker #2: They're on you know short they're on acting IV labetalol . And there's no change in blood pressure . And , you know , frankly , within minutes of getting the m189 blood pressure is coming down very , very And so we're rapidly .

Speaker #2: that pretty much every patient is seeing an immediate reduction in blood pressure . So it just gives us a lot of hope and excitement for this , for this treatment .

Speaker #7: And so you've seen an incremental dose response in that 10th cohort . And then just second on on stroke , if I can I mean , can you just us through maybe walk what your kind of expectations for enrollment rate and kind of was where it sits today .

Speaker #7: And then if you could give us an of where , you update kind know , the site activation situation sits , including kind of us .

Speaker #2: Yeah . Julie had had mentioned in the As remarks , you know , the stroke historical enrollment rates , we're you know , we were looking at around 0.25 that we had previously using .

Speaker #2: we're And seeing a little less this . And than we wanted to provide an revising the guidance . We so a little update here , over 35 sites activated .

Speaker #2: We've got a number that are coming on board. We recently had regulatory clearance in the UK. We believe we've got Europe on as well here coming soon.

Speaker #2: And so I think on board it's important for us here now that , you know , in the past , instead historical rates , we're using of looking at specific rates that we're seeing at our current sites .

Speaker #2: So that gives us a little more comfort here in terms of the revised forecast today.

Speaker #2: So that gives us a little more comfort here in terms of the the revised forecast today .

Speaker #7: enrollment rate , Rick , that you're the to assuming What get the second half target at this point .

Speaker #7: to

Speaker #2: We're not providing that at this point in time . Jace

Speaker #7: thank you for the . Okay , questions .

Speaker #2: Yep . Thanks , Jace .

Speaker #1: The next question comes from Caulfield Matthew with H.C. Wainwright . Your line is open .

Speaker #8: Hi . Thank you . Good morning , Rick and team . So as the progress is made towards the EIS interim for reaching those analysis 200 patients regarding the modified Rankin Scale score , what would what would reflect a meaningful change there , in your view , at the time of the interim analysis ?

Speaker #8: Thanks a lot .

Speaker #2: Sure . So we had initiated in the powering and really following what we saw in phase two . So in our phase two trial in the , not patients mechanical thrombectomy , there was a 15% absolute improvement in the Mrs. score of And we also had an adjustment to the protocol , excluding those with severe 0 to 1 .

Speaker #2: made patients , when they come severity so when we those stroke we saw a 19% . exclude is currently study is currently powered is that around the study that 15% , you know , we'd be looking at 3 to 350 patients for the final sample size

Speaker #1: concludes the question and answer session . Understood . I'll turn the call to Rick for closing remarks .

Speaker #2: Great . Well , thank you all for joining us today . We greatly appreciate your interest in Diamedica and hope you enjoy the rest of the day .

Speaker #2: This concludes our call . Thank you .