DiaMedica Therapeutics Inc. Q4 FY2024 earnings call

• Preeclampsia program: Obtained ethics approval, regulatory clearance, and begun dosing preeclamptic mothers. DM199 has a favorable safety profile, doesn't cross placental barrier, and can lower blood pressure in humans. - Stroke program: Activated 30 clinical sites, operating under protocol version 5.0 which expands eligibility, DSMB reviewed safety data from ReMEDy2 trial and found no significant concerns, and protocol updates were well-received by sites. - Financials: Cash and investments as of Dec 31, 2024, were $44.1M, R&D expenses increased to $19.1M in 2024 due to clinical trial continuation, G&A expenses decreased to $7.6M in 2024, and net other income increased to $2.3M in 2024.

DiaMedica Therapeutics focuses on two main clinical development programs: preeclampsia and stroke. There is no traditional product segment revenue to report. For the preeclampsia program, significant progress has been made with ethics approval, regulatory clearance, and dosing of preeclamptic mothers. The stroke program has 30 clinical sites activated, operating under protocol version 5.0, and has seen updates including expanded eligibility and positive site reception.

• Anticipates current cash and investments provide runway into Q3 2026. - Expect R&D expenses to increase moderately as company expands ReMEDy2 globally and continues preeclampsia development. - Updated expectation for interim analysis of ReMEDy2 trial to first half of 2026, with further update after 25% enrollment.

No specific risks detailed beyond general forward-looking statement disclosures regarding potential differences between projected and actual results, and risks associated with clinical trial timelines and enrollment rates.

Q: Of the 30 activated sites, how many are the 15 top sites and how many are actively enrolling?

A: Of the 30 activated sites, the top 15 comprise about 13, the vast majority are activated and many are currently enrolling.

Q: How much data did the DSMB have on patients for the review?

A: The DSMB had the entire database, including all data entered for patients up to the cutoff date.

Q: What are expectations around enrollment rates and ultimate expectation for trial sites activated for ReMEDy2?

A: Anticipate doubling the number of enrolling sites, targeting sites that can enroll 1-2 patients per month; generally takes 6-12 months to get a site up and running, and we'll provide fuller picture when hitting 25% enrollment.

Q: Since protocol amendments, are you seeing improvement in enrollment rate for TPA non-responders?

A: Since the beginning of the year, there has been a very encouraging increase in enrollment, driven in part by the protocol amendment including TPA non-responders.

Q: Feedback from KOLs on DM199 in light of IST conference studies?

A: The negative results of mechanical thrombectomy studies at IST were encouraging for sites and Scientific Advisory Board, as it makes DM199's trial more attractive.

Q: Preliminary top line in preeclampsia expected in Q2, what threshold to look for?

A: Looking for a 10-20 drop in systolic pressure, down to ~140, no evidence of DM199 crossing placental barrier, and lower pulsatility index in uterine arteries indicating better placental perfusion.

Q: Has the amended statistical analysis plan for ReMEDy2 been finalized with the FDA?

A: Yes, it has been finalized.