Grayscale Investments (GRAY) Q4 2025 earnings summary

Executive summary

• No evidence of drug-related toxicity found in the Phase 2 KOURAGE trial for AKI; trial discontinued due to mortality imbalance likely related to baseline disease severity, not the drug.

• Pivotal program design for Auxora in acute pancreatitis (AP) expected to be finalized in 1H 2026 after positive FDA engagement.

• Preclinical data for CM5480 in pulmonary arterial hypertension (PAH) published, showing potential as a differentiated therapy; IND submission anticipated in 2027.

Financial highlights

• Cash, cash equivalents, and short-term investments totaled $13.0 million as of December 31, 2025, expected to fund operations into Q4 2026.

• Research and development expenses were $15.2 million for 2025, up from $14.5 million in 2024, mainly due to increased preclinical and clinical activities.

• General and administrative expenses decreased to $7.9 million in 2025 from $9.7 million in 2024, primarily due to lower consulting and professional service costs.

• Net loss was $29.6 million ($1.97 per share) for 2025, compared to $13.7 million ($1.22 per share) in 2024, driven by higher non-cash fair value adjustments and interest expense.

Outlook and guidance

• Plans to discuss KOURAGE data and future AKI development with the FDA in Q2 2026; patient follow-up ongoing.

• Pivotal program for Auxora in AP to be finalized in 1H 2026, representing the first U.S. pivotal program for AP.

• IND submission for CM5480 in PAH anticipated in 2027, with ongoing preclinical studies.

• Cash runway expected to last into Q4 2026.