DiaMedica Therapeutics Inc. (DMAC) SEC Filings & Earnings Calls

Cash runway through 2027; no near-term financing risk.

“$43.5M cash; anticipated runway through 2027.”

Clinical trial enrollment delays

“As previously disclosed, we have experienced and continue to experience slower than expected site activations and enrollment in our ReMEDy2 trial.” · word for word

Regulatory delay for PE program

“In June 2026, we announced that the FDA provided written feedback regarding the need for additional nonclinical reproductive toxicity data to support continued development of DM199 for the treatment of PE.” · word for word

Cash runway limited to 12 months

“we expect our current cash resources will be sufficient to allow us to fund our planned operations for at least the next 12 months from the date of issuance of the condensed consolidated financial statements included in this report.” · word for word

No approved products or revenue

“We do not have commercial approval to market any product, nor have we ever had such approval.” · word for word

Regulatory risk: rabbit study antibody response may delay ePPND study

“Preliminary results of the rabbit study suggest that the animals developed an antibody response to DM199, a humanized recombinant protein, preventing us from completing the requested embryo-fetal development and pre- and postnatal development (ePPND) study in the rabbit model.” · word for word

Clinical trial risk: ReMEDy2 interim analysis results unknown

“Interim analysis remains planned for completion in the fourth quarter of 2026.” · word for word

Increasing net loss and cash burn

“Net loss was $10.0 million for Q1 2026 vs $7.7 million for Q1 2025; net cash used in operating activities $9.1M vs $7.1M.”

Clinical Trial Enrollment Delays

“We have experienced and continue to experience slower than expected site activations and enrollment in our ReMEDy2 trial.” · word for word

Regulatory Setback for PE Program

“Preliminary results of the rabbit study suggest that the animals developed an antibody response to DM199... preventing us from completing the requested ePPND study.” · word for word

Cash Runway Risk

“Cash, cash equivalents and marketable securities decreased from $59.9M to $51.3M.”

No Approved Products

“We do not have commercial approval to market any product, nor have we ever had such approval.” · word for word

Clinical-stage company with substantial losses

“As a clinical-stage company we have incurred substantial losses since our inception and expect to continue to incur substantial losses for at least two or three years.” · word for word

Significant equity dilution from outstanding options and inducement plan

“Plan Category Securities to be Issued Upon Exercise of Outstanding Options, Warrants and Rights (#) 7,039,369 ... Number of Securities Remaining Available for Future Issuance Under Equity Compensation Plans 1,601,791.” · word for word

Registration rights agreement with liquidated damages up to 10% of invested capital

“If we fail to keep the resale registration statement effective...we will be required to pay liquidated damages to the investors in an amount of up to 10% of the invested capital, excluding interest.” · word for word

Clinical trial enrollment and regulatory risks for DM199 in preeclampsia and AIS

“ReMEDy2 trial approaching 70% enrollment; interim analysis planned 2H 2026. Preeclampsia Phase 2 IST enrollment ongoing.”

Cash burn rate may increase with expanded clinical programs

“Net cash used in operating activities increased to $29.1M from $22.1M. R&D expenses expected to increase moderately.”

Clinical trial enrollment failure

“We have had and may continue to have difficulty enrolling patients in our ReMEDy2 trial, which could delay further completion of the trial or even jeopardize the viability of the trial.” · word for word

Regulatory delay for PE program

“the FDA requested an additional non-clinical, 10-day modified embryo-fetal development and pre- and postnatal development (ePPND) study in a rabbit model, a non-rodent species.” · word for word

Need for additional capital

“We will likely need additional funding to continue our clinical development activities and other operations, which may not be available to us on acceptable terms, or at all.” · word for word

PFIC tax status

“We believe that we were a PFIC for the taxable year ended December 31, 2016 and again for each of the taxable years ended December 31, 2022, 2023, 2024[, and December 31, 2025].” · word for word

Single source manufacturing dependency

“We currently have a single source of supply for our drug substance and for our drug product.” · word for word

Clinical trial enrollment delay

“we have experienced and continue to experience slower than expected site activations and enrollment in our ReMEDy2 trial” · word for word

Need for additional capital

“we expect we will need substantial additional capital to complete our R&D activities” · word for word

Regulatory approval uncertainty

“If political pressure, global health concerns, or other factors prevent the FDA or other regulatory authorities from conducting their regular reviews ... it could significantly impact the ability of the FDA to timely review and process our regulatory submissions” · word for word

Increasing net loss and cash burn rate; operating cash flow used $21.3M in 9M 2025 vs $15.6M in prior year.

“Net losses were $8.6 million and $24.0 million for the three and nine months ended September 30, 2025, respectively, up from $6.3 million and $16.5 million” · word for word

Clinical trial execution risk: ReMEDy2 interim analysis not expected until 2H 2026; preeclampsia program still in early stages.

“Enrollment in ReMEDy2 Phase 2/3 trial nearing 50% of target of 200 patients for the interim analysis expected in 2H 2026.” · word for word