Unicycive Therapeutics Reports Q2 EPS of -$0.52, Exceeds Estimates; Net Loss at $6.4 Million

Unicycive Therapeutics Inc reported a Q2 2025 net loss of $6.4 million, beating estimates of -$0.78. The company's cash and cash equivalents decreased to $22.3 million, supporting ongoing research and development activities. Despite challenges, pivotal study data highlighted OLC's safety and efficacy, positioning it as a potentially best-in-class treatment for hyperphosphatemia in dialysis patients. The company requested a Type A meeting with the FDA to resolve a Complete Response Letter and obtain regulatory approval.

Unicycive Therapeutics Inc. (Nasdaq: UNCY) has reported its financial results for the second quarter of 2025, ending June 30, 2025. The company's net loss for the quarter was $6.4 million, which was an improvement over the estimated net loss of -$0.78. This result was driven by a decrease in research and development (R&D) expenses, which fell to $1.8 million from $4.9 million in the same quarter last year. General and administrative (G&A) expenses more than doubled to $5.2 million, primarily due to increased consulting and professional services related to commercial launch preparation [1].

The company's cash and cash equivalents stood at $22.3 million as of June 30, 2025, providing sufficient resources to fund operations into the second half of 2026. Despite the financial challenges, Unicycive's pivotal study data for oxylanthanum carbonate (OLC) highlighted its safety and efficacy, positioning it as a potentially best-in-class treatment for hyperphosphatemia in dialysis patients [1].

Unicycive has requested a Type A meeting with the U.S. Food and Drug Administration (FDA) to discuss the resolution of a Complete Response Letter (CRL) received in June. The CRL was related to the New Drug Application for OLC, citing issues with a third-party manufacturing vendor. The company believes it has multiple approaches to correct the deficiency and is hopeful that the FDA will grant approval following the Type A meeting [1].

The company's focus remains on clinical validation, regulatory approval, and effective commercialization of its products. Unicycive's lead investigational treatment, OLC, is a novel phosphate binding agent for the treatment of hyperphosphatemia in patients with chronic kidney disease on dialysis. The company's second investigational treatment, UNI-494, is intended for the treatment of conditions related to acute kidney injury and has been granted orphan drug designation (ODD) by the FDA for the prevention of Delayed Graft Function (DGF) in kidney transplant patients [1].

Unicycive's financial results and regulatory progress reflect its efforts to address challenges while maintaining financial flexibility for future product launches. Investors can expect further updates later in the third quarter following FDA discussions.

References:
[1] https://finance.yahoo.com/news/unicycive-therapeutics-announces-second-quarter-110000771.html
[2] https://www.nasdaq.com/articles/unicycive-posts-65-eps-gain-q2