[8-K] Unicycive Therapeutics, Inc. Reports Material Event

Rhea-AI Filing Summary

Unicycive Therapeutics (UNCY) furnished an 8-K with preliminary cash data and a regulatory update. The company expects to report approximately $42 million in cash and cash equivalents as of September 30, 2025, based on preliminary, unaudited figures. The company’s independent registered public accounting firm has not reviewed these figures, and complete quarterly results will appear in the upcoming Form 10-Q for the quarter ended September 30, 2025.

Unicycive also furnished a press release announcing an update from its meeting with the U.S. Food and Drug Administration and the timing of the resubmission of its New Drug Application for Oxylanthanum Carbonate, following a Complete Response Letter dated June 30, 2025.

Insights

Biopharma regulatory and financial analyst

Informational 8-K: preliminary cash of $42M and NDA resubmission timing update.

Unicycive reports preliminary, unaudited cash and cash equivalents of $42,000,000 as of September 30, 2025. These figures have not been reviewed by the auditor and will be finalized in the forthcoming Form 10-Q. This provides a snapshot of liquidity but does not include operating results.

The company also notes a press release with an FDA meeting update and timing for resubmitting the NDA for Oxylanthanum Carbonate after a Complete Response Letter on June 30, 2025. The disclosure signals ongoing engagement with the FDA; actual regulatory outcomes will depend on the resubmission and agency review.

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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.

1

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

2

FAQ

What preliminary financial figure did UNCY disclose?

Unicycive expects to report approximately $42 million in cash and cash equivalents as of September 30, 2025, based on preliminary, unaudited data.

Did UNCY’s auditor review the preliminary cash figure?

No. The company states its independent registered public accounting firm has not reviewed these preliminary figures.

When will UNCY provide full quarterly results?

Complete results will be included in the Form 10‑Q for the quarter ended September 30, 2025.

What regulatory update did UNCY announce regarding Oxylanthanum Carbonate?

A press release announced an update from an FDA meeting and the timing of the NDA resubmission following a Complete Response Letter on June 30, 2025.

Is this 8-K information furnished or filed?

The information in Item 2.02 is furnished and not deemed “filed” under the Exchange Act.

What is UNCY’s Nasdaq ticker and listing venue?

Unicycive Therapeutics trades as UNCY on the Nasdaq Capital Market.