DiaMedica (DMAC) Q3 2026 Earnings Call Transcript

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DATE

Friday, Nov. 13, 2026

CALL PARTICIPANTS

• President and Chief Executive Officer - Rick Pauls
• Chief Medical Officer - Julie Krop
• Chief Financial Officer - Scott Kellen

TAKEAWAYS

• R&D Expense -- $9.2 million for the third quarter, compared with $6.4 million in the prior-year period due to clinical team expansion and ReMEDy2 global activities.
• Net Loss -- $11.3 million, or $0.21 per share, for the third quarter compared with $8.6 million, or $0.17 per share, in the prior-year period.
• Cash Balance -- $34.9 million in cash, cash equivalents, and short-term investments as of Sept. 30, 2026, reflecting a decrease from $59.9 million at the end of 2025.
• Cash Runway -- Into the fourth quarter of 2027, which management expects will fund planned clinical studies and corporate operations.
• AIS Interim Analysis Threshold -- 200 participants, a milestone reached in Oct. 2026 that triggers a prespecified independent data review.
• REMEDY2 Sample Size Range -- 300 to 728 participants, with the final number to be determined by the DSMB based on efficacy data.
• FGR Enrollment -- 12 participants enrolled across the first two cohorts of the phase 2 growth restriction study, completing those specific dose groups.
• FGR Dose Levels -- 5 micrograms per kg to 10 micrograms per kg, which were the doses evaluated in the first two cohorts of the phase 2 study.
• 9-Month Operating Cash Use -- $26 million, representing an increase from $21.3 million in the prior-year period due to higher net losses.
• Preeclampsia Trial Size -- 30 patients, the target enrollment for the global phase 2 dose-finding study across three dose levels.
• Working Capital -- $28 million as of Sept. 30, 2026, compared with $55.5 million at the end of the prior fiscal year.
• Current Liabilities -- $7.5 million at the end of the third quarter, an increase from $5.1 million as of Dec. 31, 2025.
• G&A Expense -- $2.4 million for the third quarter, a modest reduction from $2.6 million in the prior-year period driven by lower professional fees.
• Projected Stroke Enrollment -- 300 participants, a target CEO Rick Pauls indicated the study might approach by the time the interim analysis is completed in the first quarter of 2027.
• Preeclampsia Dose Range -- 5 micrograms per kg to 15 micrograms per kg, which management intends to evaluate in the upcoming Part 2 study.
• 9-Month R&D Expense -- $25.4 million, compared with $17.9 million for the same period in 2025, reflecting increased trial startup and manufacturing activities.
• Fetal Weight Severity -- 3rd percentile or less, representing the severity level of participants enrolled in the growth restriction study.
• Measurement Frequency -- Every three days for Doppler recordings once a patient has stabilized in the fetal growth restriction study.
• Preeclampsia Delivery Cause -- 50%, approximately, of early-onset patients who must deliver due to severe high blood pressure that management believe DM199 may address.
• Preeclampsia Expansion -- 12 additional patients, who will be enrolled at a selected dose level following the initial dose-finding phase of the phase 2 trial.

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RISKS

• Pauls stated, "Ultimately, we are subject to some of the constraints of administration and process at each site," regarding potential enrollment delays for the company-sponsored phase 2 study into early 2027.

SUMMARY

DiaMedica Therapeutics Inc. (NASDAQ:DMAC) reported progress on its clinical trials for DM199, which targets vascular dysfunction in stroke and pregnancy-related disorders. Management indicated that the 200th participant has been enrolled in the ReMEDy2 stroke trial, which triggers a planned interim efficacy analysis in the first quarter of 2027. The company stated that enrollment is complete for the first two dose cohorts in its phase 2 fetal growth restriction study, with preliminary data expected in late November. The company reported that regulatory authorizations from Health Canada and the European Medicines Agency support the expansion of its global phase 2 preeclampsia trial. Management stated that it is currently generating additional rat toxicology data required to support an investigational new drug application with the United States Food and Drug Administration.

• The company attained the prespecified enrollment threshold for the ReMEDy2 interim analysis, which will evaluate the proportion of participants with excellent functional outcomes at 90 days.
• CEO Pauls stated, "Switching to IV DM199 may enable further prolongation of pregnancy for these women beyond the sub q dosing," regarding a new study for late-stage preeclampsia.
• Chief Medical Officer Krop stated, "DM199 is designed to improve collateral blood flow within the ischemic penumbra," distinguishing the drug's mechanism from current reperfusion treatments.
• The company completed the in-life portion of a rat reproductive toxicology study to address specific FDA feedback concerning DM199 enzymatic activity and exposure levels.
• Management expects to host a virtual event on Nov. 24 featuring preliminary safety and clinical observations from the first two cohorts of the fetal growth restriction study.
• The company received conditional authorization from the European Medicines Agency for its phase 2 dose-finding study, creating an opportunity for future expansion into European clinical sites.

INDUSTRY GLOSSARY

• DM199 (rinbifetapenem alfa): A recombinant form of human tissue kallikrein-1 protein being developed for neurological and renal disorders.
• Fetal Growth Restriction (FGR): A pregnancy disorder where the fetus fails to reach its growth potential, often due to impaired blood flow from the placenta.
• Acute Ischemic Stroke (AIS): A condition where a blood clot blocks blood flow to the brain, requiring rapid restoration of oxygen and nutrients to preserve tissue.
• Ischemic Penumbra: The area of brain tissue surrounding the core of a stroke that receives reduced blood flow but remains viable for a limited time.
• Modified Rankin Scale (mRS): A standard measure ranging from 0 to 6 used to assess the level of disability or dependence in stroke patients.
• Preeclampsia: A serious pregnancy complication characterized by high blood pressure and potential damage to organ systems like the liver and kidneys.
• Pulsatility Index: A measure used in ultrasound to assess the resistance to blood flow within a vessel, such as the uterine or umbilical arteries.

Full Conference Call Transcript

Operator: 3 Good morning, ladies and gentlemen. And welcome to DiaMedica Therapeutics third quarter 2026 earnings Conference Call. An audio recording of today's webcast will be available following the call on DiaMedica's website. Diamedica.com. In the investor relations section. Before we begin, please note that management will be making forward-looking statements. These statements are subject to risks and uncertainty that could cause actual results to differ materially from those expressed or implied Additional information about these risks appears in the cautionary statement in the company's earnings press release issued yesterday, and in DiaMedica's filings with the Securities and Exchange Commission. Including its most recent Form 10-K and Form 10-Q. Statements on this call speak only as of today, November 13, 2026.

Following prepared remarks, we will open the call for questions. I would now like to introduce Rick Pauls, DiaMedica's president and chief executive officer. Rick, please go ahead.

Dietrich John Pauls: Thank you, operator, and good morning, everyone. Thank you for joining our third quarter earnings call. With me today are Dr. Julie Krop, our Chief Medical Officer and Scott Kellen, our chief financial officer. Since our last earnings call, we achieved 2 major clinical milestones. First, enrollment was completed in the first 2 cohorts of the investigator sponsored phase 2 early onset fetal growth restriction study. Second, in October, we enrolled the 200th participant in ReMEDy2, our pivotal phase 2/3 trial in acute ischemic stroke. With this, we attained the prespecified enrollment threshold required for the REMEDY 2 interim analysis.

Together, these milestones bring us closer to important clinical readouts that could help define the next stage of development for DM199 in fetal growth restriction preeclampsia, and acute ischemic stroke. We are also continuing to prepare for additional studies in preeclampsia including our company sponsored phase 2 trial, and made progress addressing FDA feedback on the nonclinical package needed for a U.S. investigational new drug application for preeclampsia. I will walk through the major updates. Julie will discuss the clinical objectives in more detail, and Scott will review our financial results. As a reminder, DM199 generic name rinbifetapenem alfa, is a recombinant form of human tissue kallikrein-1 or KLK1.

Through activation of the bradykinin-2 receptor pathway, we believe DM199 has the potential to improve vascular health and function. Ultimately improving blood flow. This is a completely novel mechanism of action and provides a common therapeutic rationale across preeclampsia, fetal growth restriction, acute ischemic stroke, and other diseases. Even though the clinical objectives and endpoints differ across these indications. Let me begin with early onset fetal growth restriction program, or FGR. Professor Cluver has now completed enrollment in the first 2 cohorts of the phase 2 study being conducted at Tygerberg Hospital in Cape Town, South Africa. Together, these cohorts include 12 participants with 6 treated at 5 micrograms per kg and 6 treated at 10 micrograms per kg.

This is the first clinical evaluation of DM199 in women with early onset fetal growth restriction. Early onset FGR is a pregnancy disorder associated with significant risks to the fetus, frequently resulting from placental insufficiency. Creating impaired blood flow that restricts the supply of oxygen and nutrients to the baby. Currently, no therapy is approved to treat FGR. The only option today for physicians is to closely monitor both mother and baby balancing the risk of stillbirth and fetal complications from worsening placenta against the serious neonatal risk of delivering very prematurely. Pregnancies complicated by preeclampsia, maternal risk also includes severe high hypertension and organ injury.

The current early onset FGR study is evaluating repeated subcutaneous dosing of DM199 with the objective of assessing whether DM199 safely prolong pregnancy while minimizing risk to the mother and baby. Assessments include maternal and fetal safety, measures of utero placental vascular resistance, birth weight, centile, and duration of pregnancy. The dose for the third cohort will be selected based on the findings from the first 2 cohorts. On Tuesday, November 24 at 8 a.m. eastern time, we will host a virtual key opinion leader event focusing on fetal growth restriction featuring preliminary results from both completed cohorts.

Professor Cluver will be joined by Professor Steven Tong, and Professor Susan Walker, who are from the University of Melbourne, and Professor Andrew Shannon, from King's College London. The panel will discuss the treatment landscape and unmet need, the clinical rationale for DM199, and preliminary safety and clinical observations in the context of current maternal fetal medicine best practices. Within the investigation response of trial, 2 additional preeclampsia studies are expected to begin enrollment by the end of 2026. 1 comprised of up to 30 women with early onset preeclampsia receiving repeated subcutaneous dosing of DM199 until delivery. This is referred to as our part 2 of the study.

The second study will include up to 30 women with late onset or late stage preeclampsia, who are acutely hypertensive with delivery expected within 72 hours. Referred to as Part 1b. In the second study, patients will receive DM199 via continuous intravenous infusion which may provide insight into whether IV dosing of DM199 can help control severe hypertension. We believe every day matters for mom and baby. Switching to IV DM199 may enable further prolongation of pregnancy for these women beyond the sub q dosing. We are also advancing our company sponsored phase 2 program in early onset preeclampsia.

Health Canada authorized a protocol amendment to the open label phase 2 dose finding study in September and preparations continue to initiate enrollment at Canadian sites. Also plan to expand the study into the United Kingdom subject to regulatory authorization. In October, the study received conditional authorization from the European Medicines Agency or EMA with consideration for full approval after country specific ethical and site requirements, creating an opportunity for future European expansion. This trial is designed to evaluate approximately 30 patients with early onset preeclampsia across 3 dose levels. Drawing on the Part 1a preeclampsia experience, and emerging FGR observations.

Together, both of these studies will provide further information on dosing and pharmacologic activity in different clinical settings, allowing us to develop a dosing plan for use in larger preeclampsia trials. In The United States, our focus remains on addressing FDA's feedback regarding the nonclinical reproductive toxicology data to support an investigational new drug application or IND. To study DM199 in preeclampsia in the United States. Last quarter, we discussed FDA feedback indicating that our completed rat reproductive toxicology studies may be acceptable to support an IND. FDA's acceptance would depend on our ability to demonstrate that DM199 exposure and enzymatic activity were maintained at adequate levels throughout those studies.

And that DM199 produces a sufficient pharmacologic effect in rats to justify their use as a toxicology species. We initiated an additional rat study during the third quarter, to generate this data. I am pleased to report that the in life portion of the study has been completed and DM199 was well tolerated by the animals. We expect the pharmacokinetics and pharmacologic results in the coming weeks. And once the report is complete, we plan to submit to the FDA. Our other major recent clinical milestone was an acute ischemic stroke. Where REMEDY 2 reached the enrollment threshold for its prespecified interim analysis.

Acute ischemic stroke, where a blood clot blocks blood flow to the brain, can cause profound lasting disability or death. Current reperfusion treatments including thrombolytic drugs, which attempt to dissolve the clot and mechanical thrombectomy, which attempts to physically remove the clot can be highly effective for certain eligible patients. But their use is limited by clinical eligibility, treatment time window, and the location of the clots. Most stroke patients either cannot receive these treatments or still experience significant disability despite treatment, is why stroke also remains a significant unmet medical need and additional approaches to preserve at-risk brain tissue. And improve functional recovery are urgently needed.

Following the required 90-day follow-up of the 200th participant, the independent data safety monitoring board, or DSMB, will examine the primary efficacy endpoint. The proportion of participants with a modified Rankin Scale score of 0 to 1 at day 90, indicating an excellent functional outcome. As part of the trial's prespecified adaptive design, the DSMB will use this efficacy data to determine whether the study should continue. And if so, whether the final sample size should be adjusted. If the trial continues, the final enrollment target will range from 300 to 728 participants under the prespecified statistical plan. Diomedical will remain blinded to the treatment effect data reviewed by the DSMB.

If successful, REMEDY 2 has the potential to serve as a pivotal trial supporting a future new drug application or NDA. For use of DM199 in acute ischemic stroke. Patient recruitment continues during the completion of the follow-up period and data preparations for interim review. We expect the DSMB to complete its analysis in the first quarter of 2027. With that, I will turn the call over to Julie to discuss the clinical programs in more detail. Julie?

Julie Krop: Thank you, Rick, and good morning, everyone. I would like to expand on 2 aspects of our pregnancy related development strategy. First, what are we seeking to learn from the FGR cohorts? And second, the initial preeclampsia findings are informing the next studies. Severe early onset fetal growth restriction presents a substantial challenge because impaired placental function can severely limit the fetus' ability to grow and develop As Rick noted, clinical management requires balancing the potential benefit of prolonging gestation against the maternal and fetal risk of continuing the pregnancy.

We are evaluating whether and to what degree DM199 can favorably affect vast vascular physiology to improve vascular health and blood flow and ultimately support improved outcomes for both the mother and the baby. The ongoing Phase 2 FGR IST trial is evaluating repeated subcutaneous dosing of DM199 in women with early onset disease. Key assessments include safety and tolerability, and umbilical artery Doppler indices, that reflect the degree of resistance to blood flow from the fetus to the placenta. Abnormal Doppler findings, particularly absent or reversed end diastolic flow, help guide the timing of delivery in pregnancies complicated by fetal growth restriction.

Changes in these physiologic parameters will provide important information about the pharmacologic activity of DM199 and help inform further development. At the November 24 KOL event, we will review preliminary observations from the 2 6-participant cohorts tested at DM199 subcutaneous dose levels 5 and 10 micrograms per kilogram, respectively. Although this is an early open label study involving a small number of patients, the findings will provide an initial opportunity to assess DM199 safety, pharmacologic activity, and potential clinical effects in women with early onset FGR. And importantly, the experts will help put the open label data into context by providing benchmarking data on outcomes in patients receiving current standard of care treatment.

In Part 1a of the investigator sponsored trial, patients with late onset preeclampsia were studied. If you recall, that data showed rapid and sustained reductions in maternal systolic and diastolic blood pressure following DM199 treatment. We also observed pharmacodynamic effects including trends suggesting reduction in the uterine artery pulsatility and a measure of resistance and an indirect measure of uteroplacental blood flow. Together, these observations support dose selection and provide a strong rationale for conducting additional studies to determine whether DM199 can deliver meaningful clinical benefits, particularly in early onset disease. I would also like to highlight the clinical rationale for DM199 in acute ischemic stroke. Unlike thrombolytic therapies, which dissolve blood clots or mechanical thrombectomy, which physically remove them.

DM199 is designed to improve collateral blood flow within the ischemic penumbra the surrounding brain tissue that are adversely impacted by the clot, and that remain viable for a period of time but are at risk of irreversible injury if adequate blood flow is not restored. By improving hospital delivery to the threatened tissue, we believe DM199 may help preserve neurologic function ultimately leading to improved recovery following stroke. REMEDY 2 is a randomized double blind placebo controlled study evaluating DM199 in patients with acute ischemic stroke who begin treatment within 24 hours of symptom onset. Participants receive DM199 or placebo over 3 weeks with functional recovery assessed at day 90.

The study focuses on patients who are not candidates for mechanical thrombectomy, a population with substantial unmet medical need. Across these programs, our goal is to determine whether DM199's effect on vascular function and blood flow can translate into meaningful clinical benefits for patients with these serious conditions. Rick, back to you.

Dietrich John Pauls: Thanks, Julie. I will now ask Scott to review our third quarter financial results. Scott?

Scott Kellen: Thanks, Rick, and good morning, everyone. As of September 30, 2026, we had $34.9 million in cash, cash equivalents and short term investments, compared with $59.9 million at December 31, 2025. Current liabilities were $7.5 million and working capital $28 million at quarter end, compared with $5.1 million and $55.5 million at year-end 2025. Based upon our current plans, we expect our cash, cash equivalents and short term investments to fund our planned clinical studies and corporate operations into the fourth quarter of 2027. Net cash used in operating activities for the first 9 months of 2026 was $26 million compared with $21.3 million for the first 9 months of 2025.

This increase primarily reflected the higher net loss partially offset by changes in operating assets and liabilities. Turning to the income statement. Our research and development expense was $9.2 million for the third quarter and $25.4 million for the first 9 months of 2026, compared with $6.4 million and $17.9 million for the corresponding periods of 2025. These increases were driven primarily by the expansion of our clinical team ongoing REMEDY 2 activities, including the trial's global expansion, start up activities for our phase 2 preeclampsia study in Canada and the United Kingdom, additional reproductive toxicity testing supporting our planned U.S. preeclampsia program, increased manufacturing development activity, and higher noncash share based compensation charges.

We expect that research and development expenses will increase moderately relative to recent prior periods as enrollment continues in REMEDY 2 and start up activities progress in our global phase 2 preeclampsia study. General and administrative expense was $2.4 million for the third quarter and $7.2 million for the first 9 months of 2026, compared with $2.6 million and $7.3 million, respectively, for the same periods in 2025. The modest reductions primarily reflected lower professional fees partially offset by increased non-cash share-based compensation in the current quarter and increased personnel costs over the 9 month period. We expect general and administrative expense to remain relatively steady compared with recent prior periods.

Our net loss for the third quarter was $11.3 million, or $0.21 per share compared with $8.6 million, or $0.17 per share in the third quarter of 2025. For the 9 months ended September 30, our net loss was $31.5 million, or $0.58 per share compared with $24 million, or $0.53 per share for the same period in the prior year. With that, operator, please open the call for questions.

Operator: We will now begin the question-and-answer If you would like to ask a question during this time, simply press star followed by the number 1 on your telephone keypad. Press star 1 again. And your first question comes from the line of Thomas Flaten with Lake Street Capital Markets. Please go ahead.

Thomas Flaten: Hey, good morning. I appreciate you taking the questions. Just 2 for me. Rick, assuming that current pacing is maintained, you have a projection on how many patients will be enrolled in the stroke study by the time the interim analysis reads out?

Dietrich John Pauls: Thanks, Thomas. We have not provided specific updates, but hopefully we will be getting closer to the 300th patient in total. So if 300 patients is the final amount, we hopefully only need a few more months to complete enrollment.

Thomas Flaten: Got it. And then this is a bit of in the weeds question, and I do not want to get ahead of the event in a week and a half. But you mentioned in your prepared remarks that birth weight was going to be measured in the FGR cohorts. I am just curious what you are benchmarking birth weight percentile against. Is it a projection at the time they start treatment? Or can you just help me think that 1 through?

Dietrich John Pauls: Yeah. If you could hang tight here, we will have that here, in a week and a half. And we really look forward to sharing the full results at the conference, at the event.

Thomas Flaten: Got it. Appreciate it. Thank you.

Operator: Your next question comes from the line of Stacy Ku with TD Cowen. Please go ahead.

Stacy Ku: Thanks so much for taking our questions, and we are looking forward to the KOL event in 2 weeks. So we are also going to try to get a couple of, I would say, heads up for the FGR data, as we await the detailed discussion points. A few things we can talk through your current thinking on the potential differences in dosing. As we think about hypotension and the patient population. And then 2, as we think about the patient population that you are enrolling, you said in the past, they are going to be very severe.

So you are planning to disclose what percent have concomitant preeclampsia, or are they going to be FGR patients purely And then, Julie, a question on kind of your. The recordings for vascular resistance. How frequently are we recording? The updates for facility index? So just trying to understand when we get the data, how we put it all together. And then last question, Rick, if you are willing to comment. As we get the early proof of concept for fetal growth restriction, what kind of read through would you expect as we think about the early onset preeclampsia opportunity? Those are my good questions. Thank you so much.

Dietrich John Pauls: All right. Thanks, Stacy. Yes, for the FTR data, I mean, we are going to be sharing results from the cohorts 1 and 2, so 5 and 10 micrograms per kg. And then based on that, we will share our plans in terms of the next dose. That will likely be looking at going at a higher level. While we also do believe this is a potential to in the future measure at a lower level as well. In terms of severity, so these are very severe patients. So the severity of the pulsatility indexes in the sorry, the fetal weight is in the 3rd percentile or less, whereas the official definition of fetal growth is a 10th percentile.

So these are very small, very severe severity. And then in terms of read through with regards to preeclampsia, many preeclampsia patients also have fetal growth restriction. But 1 of the main differences though is that preeclampsia patients, particularly early onset, have typically more severe endothelial dysfunction that often results in hypertension, high blood pressure. And so 1 of the things that we, you know, we feel very clearly that our drug does is control blood pressure.

So we can show positive effects in this FGR is focusing more on blood flow to the placenta and extending gestational days, I think that will have us feeling very even more excited about the prospects for preeclampsia where we think we can also address the more severe endothelial dysfunction. And, from past studies, about half of preeclampsia patients, the reason they have to deliver is high blood pressure, which we think we can also address. So, again, I think this should, if, assuming that we share some positive results, this should be very encouraging in terms of the read through. And then Julie?

Julie Krop: Yeah. Hi, Stacy. Thanks for the question. So, typically, we. So early on, they are checked more often, and then if they stabilize every 3 days is typically when we would measure them in the study.

Stacy Ku: Super helpful. Thank you so much. Looking forward to it.

Operator: Your next question comes from the line of Matthew Caulfield with H. C. Wainwright. Please go ahead.

Matthew Caufield: Looking towards the Phase II FGR interim data, what could be key signals or any initial thresholds for pregnancy elongation and observations for the uterine and umbilical artery Doppler measurements? Any additional thoughts there on what success could look like? Thanks.

Dietrich John Pauls: Yes. Thanks, Matthew. So what we will be sharing during the call is the prolongation days and we will compare that to historical controls. And so it will also depend on severity. So if we are targeting the more severe patients, they will be less prolongation expected from historical whereas they are less severe, they will be longer. And so we will share some historical data that I think will help to support a difference in terms of outcomes with what we are seeing thus far.

Matthew Caufield: And then any thoughts on the Doppler measurements?

Dietrich John Pauls: Yeah. Historically, you are looking at seeing more. You know, these patients typically only worsen. So what we believe is that even a stabilization would be good, whereas we could. If we can see an absolute reduction, that would be great. Again, to historical controls they are typically more stable to worsening, which would be increasing.

Julie Krop: And I guess in terms of the Doppler findings, you know, if you start obviously, you know, sustain reverse blood flow would be a signal for immediate delivery. And so we are looking at those signals as well and looking at absence We are looking at reversal. We are looking at, you know, forward flow. And all those things contribute along with the pulsatility index and how the baby is doing too when delivery is needed.

Dietrich John Pauls: So as Rick mentioned, there are benchmarks about how those parameters affect when gestation. You know, when to end gestation and deliver the baby.

Matthew Caufield: Excellent. Thank you, guys. Looking forward to it.

Operator: Your next question comes from the line of Chase Knickerbocker with Craig Hallum. Please go ahead.

Chase Knickerbocker: Good morning. Thanks for taking the questions. I know we have talked about this in the past, but I wanted to get your thoughts, again, as we approach interim resampling in stroke. Can you just give us a sense for how you are thinking about decision tree around the trial and resample size? So I am really asking if there are threshold of resample size at the high end of the range or continuing does it make practical sense in your mind or a threshold at which there is a go, no go decision just trying to get your thoughts there, ahead of that. Thanks.

Dietrich John Pauls: Sure. Yeah. So right now, with the interim analysis, if we are not seeing a drug effect, we will stop the study for futility. Otherwise, if we see a drug effect, a lot of it depends on the statistical analysis plan, but if we see that it is a drug effect that is comparable to what we saw in our phase 2, we would be looking at closer to 300 patients. If we see a drug effect closer to, you know, 6 percent, we would be looking at the high end of 728. So I think that will give us a very good indication in terms of where the drug effect is coming in.

Chase Knickerbocker: Okay. Got it. Maybe just on the company sponsored phase 2. I think you previously expected that first enrollment in Q4. Can you just give us a sense or a little bit more detail, just on the status there, what might be causing some delays And then you also noted that it is gonna be informed by preliminary. FGR results. So can you just give us your thoughts there on what that means for that company sponsored phase 2?

Dietrich John Pauls: Yeah. So we are doing what we can to expedite the process. So we have been providing customized contracts and budgets to simplify the process with the sites Ultimately, we are subject to some of the constraints of administration and process at each site. So we would still like to see enrollment this year, but worst case it should be early in 2027. That study will be quite comparable to the Phase II early onset in South Africa. Also looking at 3 different dose levels. We are looking at 6 patients per dose level, and then we will select 1 of those 3 doses and have an additional 12 patients.

So it will be very comparable again to the South African study. That should be starting here in the next few weeks.

Chase Knickerbocker: And then just last for me. If we think about potential IND approval in the U.S., assuming satisfactory data here shortly, Should we think about it as expanding enrollment from that current company sponsored phase 2, or is there other program plans in the U.S.? Just your thoughts there.

Dietrich John Pauls: Interesting question. Yep. Yep. that is the current plan is that it would be an expansion of the existing study that will be starting off in Canada and the U.K. And we are also already looking at what that next larger, clinical trial will look like for early onset preeclampsia. Thanks, sir.

Operator: That concludes today's question-and-answer session. I will turn the call back to Rick Pauls for closing remarks.

Dietrich John Pauls: All right. Thank you, operator, and thank you, everyone, for joining us this morning. Looking ahead, our next major milestones are for the November 24 fetal growth restriction KOL event and the expected completion of the ReMEDy2 Data Safety Monitoring Board interim analysis in the first quarter of 2027. At the same time, we are preparing to initiate our additional preeclampsia studies and advancing our U. S. Regulatory efforts. Together these activities will help inform the next stages of DM199 clinical development. Thank you for all your continued interest in DiaMedica. We look forward to updating you as these programs progress. Operator, you may now conclude the call.

Operator: This concludes today's DiaMedica Therapeutics earnings conference call. Thank you for participating. You may now disconnect.

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