Form 8-K

8-K — Unicycive Therapeutics, Inc.

Accession: 0001213900-26-035961

Filed: 2026-03-30

Period: 2026-03-30

CIK: 0001766140

SIC: 2834 (PHARMACEUTICAL PREPARATIONS)

Item: Results of Operations and Financial Condition

Item: Financial Statements and Exhibits

Documents

8-K — ea0283942-8k_unicycive.htm (Primary)

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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):

March 30, 2026

Unicycive Therapeutics, Inc.

(Exact name of registrant as specified in its charter)

Delaware

001-40582

81-3638692

(State or other jurisdiction of

(Commission File Number)

IRS Employer

incorporation or organization)

Identification No.)

1975 W. El Camino Real, Suite 204

Mountain View, CA 94040

(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 Conditions.

On March 30, 2026, Unicycive Therapeutics, Inc.

issued a press release announcing its financial results for the full  year ended December 31, 2025 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.

Item 9.01. Financial Statements and Exhibits

(d) Exhibits.

99.1

Press Release of Unicycive Therapeutics, Inc. dated March 30, 2026.

104

Cover Page Interactive Data File - the cover page XBRL tags are 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: March 30, 2026

UNICYCIVE THERAPEUTICS, INC.

By:

/s/ Shalabh Gupta

Shalabh Gupta

Chief Executive Officer

EX-99.1 — PRESS RELEASE OF UNICYCIVE THERAPEUTICS, INC. DATED MARCH 30, 2026

EX-99.1

Filename: ea028394201ex99-1.htm · Sequence: 2

Exhibit 99.1

Unicycive

Therapeutics Announces Full Year 2025 Financial Results and Provides Business Update

- Oxylanthanum carbonate (OLC) New Drug Application (NDA) resubmission under review by U.S. Food and Drug

Administration (FDA) with a Prescription Drug User Fee Act (PDUFA) target action date of June 29, 2026

- Commercial readiness activities ongoing in anticipation of potential commercial launch of OLC in 3Q26

- As of March 30, 2026 unaudited cash, cash equivalents, and marketable securities totaled $54.9 million,

with expected runway into 2027

LOS ALTOS, Calif., March 30, 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 full year ended December 31, 2025, and provided a business update.

“This year is shaping up to be pivotal for

Unicycive, underscored by the U.S. Food and Drug Administration’s acceptance of our New Drug Application resubmission for OLC and

the potential for approval and launch later this year,” said Shalabh Gupta, M.D., Chief Executive Officer of Unicycive. “With

hyperphosphatemia still uncontrolled in nearly 75% of U.S. patients with chronic kidney disease undergoing dialysis, OLC, if approved,

has the potential to offer a meaningful new treatment option characterized by a differentiated clinical profile and reduced pill burden

compared to currently available phosphate binders.”

Key Highlights & Upcoming Milestones

● In January 2026, the Company announced the FDA has accepted the resubmission of its NDA for OLC, an investigational oral phosphate

binder for the treatment of hyperphosphatemia in patients with CKD on dialysis. The FDA set a PDUFA target action date of June 29, 2026.

The NDA is supported by data from three clinical studies (a Phase 1 study in healthy volunteers, a bioequivalence study in healthy volunteers

and a tolerability study in patients with CKD on dialysis), multiple preclinical studies and chemistry, manufacturing and controls (CMC)

data. The FDA did not raise any concerns regarding the preclinical, clinical or safety data for OLC included in the original NDA submission.

The resubmission in December 2025 was based on the progress made by the third-party manufacturing vendor responsible for the drug product

(Drug Product).

● As part of Unicycive’s continued preparation to support a potential launch of OLC later this year, the Company is continuing

to strengthen its commercial infrastructure and advance market readiness initiatives.

Financial Results for the Year Ended December

31, 2025

Research and Development (R&D) expenses were

$9.1 million for the year ended December 31, 2025, compared to $20.0 million for the same period in 2024. The decrease in research and

development expenses was primarily due to a decrease in drug development as well as clinical trial costs.

General and Administrative (G&A) expenses

were $20.4 million for the year ended December 31, 2025, compared to $12.1 million for the same period in 2024. The increase was primarily

due to an increase in consulting, professional services, and commercial launch preparation costs.

Other income was $3.0 million for the year ended

December 31, 2025 compared to Other expense of $4.6 million in the same period in 2024 due primarily to a decrease in the fair value of

the Company’s warrant liability.

Net loss attributable to common stockholders for

the year ended December 31, 2025 was $26.6 million, or $1.67 per share of common stock, compared to a net loss attributable to common

stockholders of $37.8 million, or $5.65 per share of common stock for the same period in 2024. The decreased net loss for the year ended

December 31, 2025, was attributable primarily to the decrease in drug development and clinical trial costs.

As of March 30, 2026 unaudited cash, cash equivalents,

and marketable securities totaled $54.9 million. The Company believes that it has sufficient resources to fund planned operations into

2027.

About Unicycive Therapeutics

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 currently under review by the U.S. Food and Drug Administration (FDA) 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.

Forward-looking statements

Certain statements in this press release are forward-looking within the meaning of the Private Securities Litigation Reform Act of 1995.

These statements may be identified using words such as “anticipate,” “believe,” “forecast,” “estimated”

and “intend” or other similar terms or expressions that concern Unicycive’s expectations, strategy, plans or intentions. These

forward-looking statements are based on Unicycive’s current expectations and actual results could differ materially. There are several

factors that could cause actual events to differ materially from those indicated by such forward-looking statements. These factors include,

but are not limited to, clinical trials involve a lengthy and expensive process with an uncertain outcome, and results of earlier studies

and trials may not be predictive of future trial results; our clinical trials may be suspended or discontinued due to unexpected side

effects or other safety risks that could preclude approval of our product candidates; our dependence on third parties for manufacturing;

risks related to business interruptions, which could seriously harm our financial condition and increase our costs and expenses; dependence

on key personnel; substantial competition; uncertainties of patent protection and litigation; dependence upon third parties; market acceptance

of our products; and risks related to failure to obtain FDA clearances or approvals and noncompliance with FDA regulations. Actual results

may differ materially from those indicated by such forward-looking statements as a result of various important factors, including: the

uncertainties related to market conditions and other factors described more fully in the section entitled ‘Risk Factors’ in

Unicycive’s Annual Report on Form 10-K for the year ended December 31, 2025, and other periodic reports filed with the Securities

and Exchange Commission. Any forward-looking statements contained in this press release speak only as of the date hereof, and Unicycive

specifically disclaims any obligation to update any forward-looking statement, whether as a result of new information, future events or

otherwise.

Investor Contacts:

Kevin Gardner

LifeSci Advisors

kgardner@lifesciadvisors.com

Media Contact:

Layne Litsinger

Real Chemistry

llitsinger@realchemistry.com

SOURCE: Unicycive Therapeutics, Inc.

Unicycive

Therapeutics, Inc.

Balance Sheets

(in thousands, except for share and per share amounts)

As of

December 31,

2024

2025

Assets

Current assets:

Cash

$ 26,142

$ 29,198

Prepaid expenses and other current assets

4,806

7,692

Marketable securities

12,071

Total current assets

30,948

48,961

Right of use asset, net

645

108

Property and equipment, net

Total assets

$ 31,668

$ 49,135

Liabilities and stockholders’ equity

Current liabilities:

Accounts payable

$ 1,058

$ 383

Accrued liabilities

3,562

1,523

Warrant liability

18,936

16,915

Operating lease liability - current

564

117

Total current liabilities

24,120

18,938

Operating lease liability - long term

117

Total liabilities

24,237

18,938

Commitments and contingencies

Stockholders’ equity:

Series A-2 Prime preferred stock, $0.001 par value per share - 21,388.01 Series A-2 Prime shares authorized at December 31, 2024, and December 31, 2025; 6,150.21 and 2,265 Series A-2 Prime shares issued and outstanding at December 31, 2024, and December 31, 2025, respectively

Series B-2 preferred stock, $0.001 par value per share - 50,000 Series B-2 shares authorized at December 31, 2024, and December 31, 2025; 3,000 and zero Series B-2 shares issued and outstanding at December 31, 2024, and December 31, 2025, respectively

Preferred stock, $0.001 par value per share- 10,000,000 shares authorized at December 31, 2024, and December 30, 2025; zero shares issued and outstanding at December 31, 2024, and December 31, 2025

Common stock, $0.001 par value per share - 400,000,000 shares authorized at December 31, 2024, and December 31, 2025; 11,384,236 and 22,114,245 shares issued and outstanding at December 31, 2024, and December 31, 2025, respectively

Accumulated other comprehensive loss

(1 )

Additional paid-in capital

108,690

158,001

Accumulated deficit

(101,270 )

(127,825 )

Total stockholders’ equity

7,431

30,197

Total liabilities and stockholders’ equity

$ 31,668

$ 49,135

Unicycive

Therapeutics, Inc.

Statements of Operations

(in thousands, except for share and per share amounts)

Year Ended

December 31,

2024

2025

Operating expenses:

Research and development

$ 20,014

$ 9,121

General and administrative

12,103

20,396

Total operating expenses

32,117

29,517

Loss from operations

(32,117 )

(29,517 )

Other income (expenses):

Interest income

1,261

1,012

Interest expense

(71 )

Change in fair value of warrant liability

(5,802 )

2,021

Total other income (expenses)

(4,612 )

2,962

Net loss

(36,729 )

(26,555 )

Other comprehensive loss:

Unrealized loss on marketable securities, net

(1 )

Net comprehensive loss

$ (36,729 )

$ (26,556 )

Dividend to Series B-1 preferred stockholders

(1,095 )

Net loss attributable to common stockholders

$ (37,824 )

$ (26,555 )

Net loss per share attributable to common stockholders, basic and diluted

$ (5.65 )

$ (1.67 )

Weighted-average shares outstanding used in computing net loss per share, basic and diluted

6,698,513

15,886,876

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