Quarterly ResultAug 12, 2026, 08:08 AM
Unicycive Q2 Net Loss $(1.7)M; FDA Assigns OLC Facility Inspection
AI Summary
Unicycive Therapeutics announced its second quarter 2026 financial results, reporting a net loss of $(1.7) million, or $(0.06) per share, a significant improvement from $(6.5) million in the prior year. The company also provided a business update, stating that the FDA has assigned a facility inspection to its third-party manufacturing vendor for oxylanthanum carbonate (OLC). This inspection is a critical step towards resubmitting the New Drug Application (NDA) for OLC, following previous Complete Response Letters related to manufacturing deficiencies. Unicycive expects its cash runway to extend into 2027, with $61.4 million in cash, cash equivalents, and marketable securities as of June 30, 2026.
Key Highlights
- Q2 2026 net loss was $(1.7) million, or $(0.06) per share.
- Q2 2025 net loss was $(6.5) million, or $(0.52) per share.
- FDA assigned a facility inspection for OLC manufacturing vendor.
- Company expects OLC NDA resubmission after successful inspection.
- Cash, cash equivalents, and marketable securities totaled $61.4 million.
- Expected cash runway into 2027.
- Q2 2026 R&D expense increased to $2.8 million.
- Q2 2026 G&A expense increased to $7.4 million.
Price Impact
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