Vivoryon Therapeutics (VVY) Q2 2024 earnings summary

Executive summary

• Strategic focus shifted from Alzheimer's disease to kidney disease and inflammatory/fibrotic disorders after disappointing AD results, leveraging compelling kidney function data from the VIVIAD Phase II-B study.

• Varoglutamstat demonstrated statistically significant improvement in kidney function (eGFR), especially in diabetic subgroups, with a benefit of 3.4 mL/min/1.73m2/year overall and >8 mL/min/1.73m2/year in diabetes subgroup, and showed excellent safety and tolerability up to 600mg BID.

• Planning a Phase II study in advanced diabetic kidney disease (DKD), subject to additional funding or partnerships.

• The company is pursuing additional indications and partnerships, with ongoing non-clinical studies and further analysis of VIVA-MIND data expected by year-end.

• Management changes included a new CFO and board member transitions; all AGM agenda items approved, including share nominal value reduction.

Financial highlights

• No revenue reported for H1 2024 or H1 2023.

• Research and development expenses rose to €10.3 million in H1 2024 from €6.3 million in H1 2023, mainly due to increased clinical costs for VIVIAD and VIVA-MIND studies.

• General administrative expenses decreased to €3.5 million from €4.4 million year-over-year.

• Net loss for H1 2024 was €13.6 million, compared to €10.7 million in H1 2023.

• Cash and cash equivalents stood at €15.3 million as of June 30, 2024, down from €28.6 million at year-end 2023.

Outlook and guidance

• Cash and cash equivalents are expected to fund operations into Q2 2025; additional financing or partnerships required for the planned Phase II DKD study and to extend runway.

• Phase II study in advanced DKD planned, targeting stage 3b/4 patients on top of standard of care, with interim analysis expected at month 15 and trial cost estimated at €10–12 million.

• Continued analysis of VIVA-MIND data and non-clinical studies to inform future pipeline priorities.