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2025-06-30
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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): June 30, 2025
Unicycive Therapeutics, Inc.
(Exact
name of registrant as specified in its charter)
| Delaware |
|
001-40582 |
|
81-3638692 |
| (State
or other jurisdiction |
|
(Commission
File Number) |
|
IRS
Employer |
| of
incorporation or organization) |
|
|
|
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
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) |
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 |
2
