Unicycive Therapeutics reported its third‑quarter 2025 results, posting a net loss of $6.0 million—an increase from the $4.1 million loss recorded in the same period a year earlier. Research and development spending rose to $3.0 million, while general and administrative costs climbed to $4.4 million, reflecting intensified investment in commercial launch preparations for its lead phosphate‑binder candidate, oxylanthanum carbonate (OLC). Cash and cash equivalents stood at $42.7 million as of September 30, giving the company a runway that management projects will extend into 2027.
The company’s earnings per share missed the consensus estimate of $‑0.59, a shortfall largely attributable to the higher G&A outlay and a fair‑value adjustment to warrant liabilities. The miss underscores the impact of the company’s strategic spending on future commercialization, even as it continues to fund clinical development.
Comparing sequentially, the second quarter of 2025 saw a net loss of $6.4 million, R&D expenses of $1.8 million, and G&A costs of $5.2 million. The Q3 increase in G&A, offset by a modest rise in R&D, indicates a shift toward preparing for the upcoming regulatory submission while maintaining a lean research budget.
Regulatory progress remains a central focus. Unicycive received a Complete Response Letter on June 30, 2025, citing a single deficiency related to a third‑party manufacturing vendor. Following a Type A meeting with the FDA, the company has engaged the vendor to resolve the issue and reiterated its plan to resubmit the New Drug Application for OLC by year‑end, targeting a PDUFA date in the first half of 2026.
Cash generation has been robust, with at‑the‑market sales through Guggenheim contributing approximately $38.6 million over the nine months to September 30. A 1‑for‑10 reverse stock split, effective in June, has reduced the share count, improving per‑share liquidity. The strong cash position and projected runway reduce the immediate need for additional capital raises, allowing the company to focus on regulatory milestones and early‑stage commercialization.
CEO Shalabh Gupta emphasized that the company remains committed to advancing OLC and resubmitting the NDA by year‑end. He highlighted the reduced pill burden of OLC as a key differentiator and expressed confidence that the company’s strategic investments will position it for a successful launch once regulatory hurdles are cleared.
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