Current Report · Items 2.02, 9.01 · 8-K

Unicycive Therapeutics, Inc.

UNCYNASDAQEQUITYCurrent

Results of Operations and Financial Condition

Filed Aug 12, 2026Accepted Aug 12, 2026, 8:04 AM EDTCIK 1766140Accession 0001213900-26-088061

Company context

Unicycive Therapeutics is a biotechnology company developing novel treatments for kidney diseases. Unicycive’s lead investigational treatment is oxylanthanum carbonate, a novel phosphate binding agent for the treatment of hyperphosphatemia in patients with chronic kidney disease who are on dialysis. Unicycive’s second investigational treatment UNI-494 is intended for the treatment of conditions related to acute kidney injury. It has been granted orphan drug designation (ODD) by the FDA for the prevention of Delayed Graft Function (DGF) in kidney transplant patients and has completed a Phase 1 dose-ranging safety study in healthy volunteers. For more information, please visit Unicycive.com and follow us on LinkedIn and X.

Current securities

UNCYNASDAQ · EQUITY · Current

Recent company filings

Disclosure sections

Items 2.02, 9.01

Select an item to read the extracted section. The as-filed document remains the primary evidence.

Item 2.02Item 2.02 - Results of Operations

Item 2.02 Results of Operations and Financial Conditions. On August 12, 2026, Unicycive Therapeutics, Inc. issued a press release announcing its financial results for the second quarter ended June 30, 2026 and provided a business update. A copy of the press release is furnished as Exhibit 99.1 to this Form 8-K. The information disclosed under this Item 2.02, including Exhibit 99.1 hereto, is being furnished and shall not be deemed “filed” for purposes of Section 18 of the Securities Exchange Act of 1934, as amended, nor shall it be incorporated by reference into any registration statement or other document pursuant to the Securities Act of 1933, as amended, except as expressly set forth in such filing.

Filed exhibits (1)

EX-99.1 (by filename) ea030169901ex99-1.htm

EX-99.1 2 ea030169901ex99-1.htm PRESS RELEASE OF UNICYCIVE THERAPEUTICS, INC. DATED AUGUST 12, 2026 Exhibit 99.1 Unicycive Therapeutics Announces Second Quarter 2026 Financial Results and Provides Business Update - Company expects to resubmit New Drug Application (NDA) for oxylanthanum carbonate (OLC) assuming completion of successful inspection of third-party manufacturing vendor - FDA has assigned a facility inspection to third-party manufacturing vendor of OLC - As of June 30, 2026, unaudited cash, cash equivalents, and marketable securities totaled $61.4 million, with expected runway into 2027 MOUNTAIN VIEW, Calif., August 12, 2026 -- Unicycive Therapeutics, Inc. (Nasdaq: UNCY), a clinical-stage biotechnology company developing therapies for patients with kidney disease, today announced its financial results for the second quarter ended June 30, 2026, and provided a business update. “We are focused on securing approval of oxylanthanum carbonate (OLC) and remain confident in the efficacy and safety of OLC and in its potential to improve care for patients with hyperphosphatemia on dialysis,” said Shalabh Gupta, M.D., Chief Executive Officer of Unicycive. “The latest upd…

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