DiaMedica Therapeutics (DMAC) Q4 2021 earnings summary

Executive summary

• Advanced DM199 for acute ischemic stroke (AIS): ReMEDy2 Phase 2/3 began site activation and enrolled its first patient; the FDA granted Fast Track and accepted stroke recurrence as an independent primary endpoint.

• DM199’s REDUX Phase 2 chronic kidney disease (CKD) trial completed enrollment; interim findings included reduced albuminuria in IgA nephropathy and hypertensive African American cohorts.

Financial highlights

• FY2021 net loss was $13.6M versus $12.3M in FY2020; operating expenses were $13.6M versus $12.7M.

• FY2021 R&D expense was $8.8M versus $8.2M; G&A was $4.9M versus $4.5M, while other income, net, was $0.1M versus $0.4M.

• Basic and diluted net loss per share was $0.65 in FY2021 versus $0.78 in FY2020; weighted-average shares were 20.8M versus 15.7M.

• No product-sales revenue had been generated; accumulated deficit was $82.5M at December 31, 2021.

Outlook and guidance

• FY2022 expenses and operating losses were expected to increase as ReMEDy2 site activation and enrollment continued, REDUX follow-up was completed, and the team and intellectual-property portfolio expanded.

• Cash, cash equivalents and marketable securities were expected to fund planned operations for at least 12 months from the financial-statement issuance date, including ReMEDy2 and REDUX follow-up.

• REDUX follow-ups and final analysis were expected to conclude by mid-2022; ReMEDy2’s blinded interim analysis was targeted for H1 2023.

• No product-sales revenue was expected for at least three to five years; substantial additional capital was anticipated to advance DM199 development and regulatory work.