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8-K2026-05-12· deepseek-chat

UNCY · Unicycive Therapeutics, Inc.

0001213900-26-054736

SEC filing

Summary

Unicycive Therapeutics reported Q1 2026 net loss of $12.8 million, driven by warrant liability fair value changes, while advancing OLC NDA with PDUFA date of June 29, 2026.

Key takeaways

Full analysis

Unicycive Therapeutics reported a net loss of $12.8 million for Q1 2026, compared to net income of $0.5 million in the same period last year. The significant swing was primarily driven by a $4.8 million expense from the change in fair value of warrant liability, versus an $8.3 million gain in Q1 2025. Operating loss widened to $8.4 million from $8.0 million, as R&D expenses decreased to $1.6 million (down from $2.2 million) due to lower drug development costs, while G&A expenses increased to $6.8 million (up from $5.8 million) due to higher consulting, professional services, and labor costs. The company ended the quarter with $54.6 million in cash, cash equivalents, and marketable securities (excluding $2.5 million in restricted cash), and as of May 11, 2026, total liquidity was $57.1 million, sufficient to fund operations into 2027. The key catalyst remains the FDA's PDUFA target action date of June 29, 2026, for the OLC NDA resubmission. Management expressed optimism and noted constructive dialogue with the FDA. Commercial readiness activities are ongoing, including the UniSource reimbursement hub to optimize patient access. The company's second program, UNI-494 for acute kidney injury, has orphan drug designation and completed a Phase 1 study. The increased net loss and warrant liability volatility are notable, but the focus remains on the upcoming PDUFA decision.