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UNITED
STATES
SECURITIES
AND EXCHANGE COMMISSION
Washington,
DC 20549
FORM 8-K
CURRENT
REPORT
Pursuant
to Section 13 or 15(d) of the Securities Exchange Act of 1934
Date
of Report (Date of earliest event reported): October 28, 2025
Unicycive Therapeutics, Inc.
(Exact
name of registrant as specified in its charter)
| Delaware |
|
001-40582 |
|
81-3638692 |
(State
or other jurisdiction of
incorporation or organization) |
|
(Commission
File Number) |
|
IRS
Employer
Identification No.) |
4300 El Camino Real, Suite 210
Los
Alto, CA 94022
(Address
of principal executive offices)
Registrant’s
telephone number, including area code: (650) 351-4495
(Former
name or former address, if changed since last report)
Securities
registered pursuant to Section 12(b) of the Act:
| Title of each class: |
|
Trading Symbol(s) |
|
Name of each exchange on which registered: |
| Common Stock |
|
UNCY |
|
Nasdaq
Capital Market |
Check
the appropriate box below if the Form 8-K filing is intended to simultaneously satisfy the filing obligation of the registrant under
any of the following provisions:
| ☐ | Written
communication pursuant to Rule 425 under the Securities Act (17 CFR 230.425) |
| ☐ | Soliciting material pursuant to Rule 14a-12 under the
Exchange Act (17 CFR 240.14a-12) |
| ☐ | Pre-commencement communications pursuant to Rule 14d-2(b) under
the Exchange Act (17 CFR 240.14d-2(b)) |
| ☐ | Pre-commencement communications pursuant to Rule 13e-4(c) under
the Exchange Act (17 CFR 240.13e-4(c)) |
Indicate
by check mark whether the registrant is an emerging growth company as defined in as defined in Rule 405 of the Securities Act of
1933 (§230.405 of this chapter) or Rule 12b-2 of the Securities Exchange Act of 1934 (§240.12b-2 of this chapter).
Emerging growth company ☒
If
an emerging growth company, indicate by check mark if the registrant has elected not to use the extended transition period for complying
with any new or revised financial accounting standards provided pursuant to Section 13(a) of the Exchange Act.
Item
2.02. Results of Operations and Financial Condition
On
October 28, 2025, Unicycive Therapeutics, Inc. (the “Company”) issued a press release that included information with respect to certain
preliminary, unaudited financial results of the Company.
While
the Company has not finalized its full financial results for the quarter ended September 30, 2025, the Company expects to report that
it had approximately $42 million of cash and cash equivalents as of September 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 September 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 September 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. Complete quarterly results
will be included in the Company’s Quarterly Report on Form 10-Q for the quarter ended September 30, 2025.
The
information in this Item 2.02 is intended to be furnished and shall not be deemed “filed” for purposes of Section 18
of the Securities Exchange Act of 1934, as amended (the Exchange Act), or otherwise subject to the liabilities of that section or Sections
11 and 12(a)(2) of the Securities Act of 1933, as amended (the Securities Act), nor shall it be deemed incorporated by reference in any
filing under the Securities Act or the Exchange Act, except as expressly set forth by specific reference in such filing.
Item
8.01. Other Events
On
October 28, 2025, the Company issued a press release announcing an update from its meeting with the U.S. Food and Drug Administration
and timing of the resubmission of its New Drug Application for Oxylanthanum Carbonate following receipt of a Complete Response
Letter on June 30, 2025. A copy of the press release is furnished as Exhibit 99.1 to this Current Report on Form 8-K.
Item
9.01. Financial Statements and Exhibits
(d)
Exhibits.
| 99.1 |
|
Press Release of Unicycive Therapeutics, Inc. dated October 28, 2025. |
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:
October 28, 2025
| |
UNICYCIVE
THERAPEUTICS, INC. |
| |
|
| |
By: |
/s/
Shalabh Gupta |
| |
|
Shalabh
Gupta |
| |
|
Chief
Executive Officer |
