DiaMedica Therapeutics (DMAC) Q4 2020 earnings summary

Executive summary

• 2020 progress centered on DM199 for acute ischemic stroke (AIS) and chronic kidney disease (CKD): Phase 2 AIS results showed safety and a signal for fewer severe recurrent strokes; CKD trials continued amid COVID-19 enrollment delays.

• The clinical-stage business remains pre-revenue and loss-making, but two 2020 share offerings materially strengthened liquidity and were expected to fund planned operations for at least 12 months from the financial-statement issuance date.

Financial highlights

• FY2020 net loss was $12.3M versus $10.6M in FY2019; operating loss was $12.7M versus $11.6M, with no product-sales revenue.

• R&D expense was $8.3M versus $7.9M; G&A was $4.4M versus $3.7M, reflecting higher share-based compensation, professional services and D&O insurance, partly offset by lower travel costs.

• Cash, cash equivalents and marketable securities were $27.5M at Dec. 31, 2020 versus $7.9M a year earlier; working capital was $25.9M versus $7.5M.

• Basic and diluted net loss per share was $0.78 in FY2020 versus $0.89 in FY2019; weighted-average shares rose to 15.68M from 11.99M.

Outlook and guidance

• Cash resources were expected to fund all three REDUX cohorts, initiate the AIS Phase 2/3 study and support planned operations for at least 12 months from financial-statement issuance; additional capital will be needed for further development.

• REDUX Cohorts I and II were expected to complete in H2 2021; preliminary DKD Cohort III results were expected in Q2 2021.

• The proposed adaptive, randomized, double-blind, placebo-controlled AIS Phase 2/3 study targeted ~300–350 participants, with a day-90 modified Rankin Scale primary endpoint and potential interim sample-size adjustment.

• Near-term spending was expected to rise with CKD trial completion, AIS trial launch, manufacturing process development and G&A support; no product-sale revenue was expected for at least three to five years.