UNITED STATES
SECURITIES AND EXCHANGE COMMISSION
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FORM
CURRENT REPORT
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Item 2.02. Results of Operations and Financial Condition
The information set forth below in the second paragraph of Item 8.01 of this Current Report on Form 8-K is incorporated by reference herein.
Item 8.01 Other Events.
On June 30, 2025, Unicycive Therapeutics, Inc. (the “Company”) issued a press release announcing that the U.S. Food and Drug Administration (FDA) has issued a Complete Response Letter for its New Drug Application (NDA) for oxylanthanum carbonate (OLC) to treat hyperphosphatemia in patients with chronic kidney disease on dialysis. A copy of the press release is furnished as Exhibit 99.1 to this Current Report on Form 8-K and incorporated by reference herein.
While the Company has not finalized its full financial results for the quarter ended June 30, 2025, the Company expects to report that it had approximately $20.7 million of cash and cash equivalents as of June 30, 2025. This estimate is preliminary and is subject to change pending the actual results of, and completion of, the Company’s condensed consolidated financial statements for the quarter ending June 30, 2025. Additional information and disclosures would be required for a more complete understanding of the Company’s financial position and results of operations as of June 30, 2025. The Company’s independent registered public accounting firm has not reviewed or performed any procedures with respect to this preliminary information and, accordingly, does not express an opinion or any other form of assurance about them.
Item 9.01. Financial Statements and Exhibits
(d) Exhibits.
| 99.1 | Press Release of Unicycive Therapeutics, Inc. dated June 30, 2025. |
| 104 | Cover Page Interactive Data File (embedded within the Inline XBRL document) |
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SIGNATURE
Pursuant to the requirements of the Securities Exchange Act of 1934, the Registrant has duly caused this report to be signed on its behalf by the undersigned hereunto duly authorized.
Dated: June 30, 2025
| UNICYCIVE THERAPEUTICS, INC. | ||
| By: | /s/ Shalabh Gupta | |
| Shalabh Gupta | ||
| Chief Executive Officer | ||
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