DiaMedica Therapeutics Inc. Q3 FY2024 earnings call

Stroke Program

• Progress on AIS study: 13 of top 15 sites either fully activated or with signed agreements, with top 5 sites anticipated to enroll disproportionately. Houston Methodist, Chattanooga, and Oregon Health sites activated or in process. Canada to add 5-7 sites. Implemented protocol update to accelerate enrollment, using refrigerated vials for investigational product.

Preeclampsia Program

• Secured regulatory approval from South African Health Products Regulatory Authority, with first pregnant participant enrolled. DM199 has potential to be disease-modifying, with Part 1a study announcement expected in first half 2025.

ReMEDy2 Trial Updates

• Protocol updates submitted to FDA in August, no comments received. Included tPA non-responders and increased interim analysis sample size from 144 to 200, enhancing Bayesian simulation power. These updates aim to accelerate enrollment, improve response rate, and optimize interim analysis for better sample size determination.

No distinct product segments with revenue contributions were detailed; focus was on stroke and preeclampsia programs.

Stroke Program

• Anticipate top 5 U.S. sites activated and recruiting by end of 2024. Interim analysis for ReMEDy2 now expected in Q4 2025.

Preeclampsia Program

• Part 1a study of DM199 in preeclampsia to be announced in first half 2025.

None specifically detailed in the transcript beyond general forward-looking statement risks mentioned at the start regarding actual results differing from projections.

Q: What was the original prompt for re-evaluating the protocol and statistical analysis plan for ReMEDy2?

A: It was a combination of wanting to simulate enrollment and extensive discussions with SAB and KOL experts, including statistical input for Bayesian sample size adjustment.

Q: At what point will patients now be randomized, particularly those that are tPA failures?

A: If patients are randomized, they won't receive tPA; they'll be randomized into the study. If they receive tPA prior to randomizing, we'll wait 6 hours to determine if they're a non-responder and can enter the study.

Q: With the change to 200 for interim analysis, when should we expect enrollment to complete?

A: With interim analysis in Q4 2025, enrollment completion is expected some time next summer.

Q: Does the change to include tPA non-responders have a material impact to DM199's commercial opportunity?

A: Yes, it's expected to expand the patient opportunity, with potential to expand label and increase revenue, including over $1 billion in additional U.S. revenue from expanding to tPA non-responder patients.

Q: With preeclampsia dosing now commenced, will there be any patients that would have received one versus the other (frozen vs refrigerated vials)?

A: Initially, patients will receive the frozen product, but primarily they'll be using refrigerated products, and there's no anticipation of distinction between the two as they're identical.

Q: Is there risk the FDA provides subsequent feedback necessitating trial modification once changes are up and running?

A: Traditionally, FDA responds within 30 days, and since we're well past that mark, chances of additional substantive feedback are relatively low.