Unicycive Therapeutics, Inc.

Unicycive Therapeutics, Inc. announced the appointment of Meredith S. Manning as an independent director to its board, effective October 1, 2026. Ms. Manning will also chair the Nominating and Corporate Governance Committee and serve on the Audit and Compensation Committees. In a separate announcement, the company resubmitted its New Drug Application (NDA) for oxylanthanum carbonate, an oral phosphate binder for hyperphosphatemia in chronic kidney disease patients. The resubmission includes updated CMC data from a new manufacturing vendor, and the company anticipates FDA acceptance within 30 days with a PDUFA date six months thereafter. The company's current cash position provides runway into the second half of 2027.

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.

Unicycive Therapeutics announced its Q2 2026 financial results and a business update, highlighting that the FDA has assigned a facility inspection for its third-party manufacturing vendor of oxylanthanum carbonate (OLC). The company plans to resubmit its New Drug Application (NDA) for OLC following a successful inspection. Financially, Unicycive reported $61.4 million in cash, cash equivalents, and marketable securities as of June 30, 2026, providing a runway into 2027. The net loss for the quarter significantly decreased to $(1.7) million.

Unicycive Therapeutics reported a net loss of $(14.5) million for the six months ended June 30, 2026, compared to a net loss of $(5.9) million in the prior year period. The company significantly increased its cash and cash equivalents to $44.2 million as of June 30, 2026, up from $29.2 million at December 31, 2025. This increase was primarily driven by net proceeds of approximately $34.0 million from the sale of common stock through a sales agreement. Unicycive continues to incur operating losses as it develops its drug candidates, UNI 494 and Renazorb, but believes it has sufficient resources for at least one year.

Unicycive Therapeutics, Inc. reported an ending cash balance of approximately $61.4 million as of June 30, 2026. These figures represent preliminary results for the second quarter and have been prepared by management, without audit or review by independent accountants.

Unicycive Therapeutics announced it received a Complete Response Letter (CRL) from the U.S. Food and Drug Administration (FDA) for its New Drug Application (NDA) for oxylanthanum carbonate (OLC). The CRL cited deficiencies at a third-party manufacturing vendor, which were previously identified in a June 2025 CRL. The FDA did not raise concerns about OLC's clinical efficacy or safety data and did not request additional data, with labeling discussions currently in progress.

Unicycive Therapeutics, Inc. announced an increase in its at-the-market (ATM) offering capacity. The company amended its Sales Agreement with Guggenheim Securities, LLC to raise the aggregate offering price for its common stock to up to $150,000,000, an increase of $50,000,000. This capital raise is facilitated through an ATM offering, with a corresponding Shelf Registration Statement on Form S-3 filed with the SEC.

Unicycive Therapeutics announced its financial results for the first quarter ended March 31, 2026, and provided a business update. The FDA review of its oxylanthanum carbonate (OLC) New Drug Application (NDA) resubmission remains on track, with a PDUFA target action date of June 29, 2026. The company is also continuing commercial readiness activities for the potential launch of OLC. For Q1 2026, Unicycive reported a net comprehensive loss of $(12.8) million, or $(0.54) per share, primarily due to an increase in the fair value of its warrant liability. As of May 11, 2026, the company held $57.1 million in cash, cash equivalents, and marketable securities, sufficient to fund operations into 2027.

Unicycive Therapeutics announced that the FDA review of its oxylanthanum carbonate (OLC) New Drug Application (NDA) resubmission remains on track, with a Prescription Drug User Fee Act (PDUFA) target action date of June 29, 2026. The company is continuing commercial readiness activities for a potential launch. For the first quarter ended March 31, 2026, Unicycive reported a net comprehensive loss of $(12.8) million, or $(0.54) per share, compared to a net income of $0.5 million, or $0.04 per share, in the prior year period. As of May 11, 2026, cash, cash equivalents, and marketable securities totaled $57.1 million, expected to fund operations into 2027.

Unicycive Therapeutics reported a net loss of $(12.8) million for the three months ended March 31, 2026, a significant decline from a net income of $0.6 million in the prior year period. The company's cash and cash equivalents increased to $37.4 million, primarily driven by $19.6 million in net proceeds from a secondary public offering. Operating expenses increased, and the change in fair value of warrant liability negatively impacted results.