Form 8-K

8-K — Unicycive Therapeutics, Inc.

Accession: 0001213900-26-054736

Filed: 2026-05-12

Period: 2026-05-12

CIK: 0001766140

SIC: 2834 (PHARMACEUTICAL PREPARATIONS)

Item: Results of Operations and Financial Condition

Item: Financial Statements and Exhibits

Documents

8-K — ea0290277-8k_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): May 12, 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.

May 12, 2026, Unicycive Therapeutics, Inc. issued a press release announcing its financial results for the first quarter ended March 31,

2026 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 May 12, 2026.

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:

May 12, 2026

UNICYCIVE THERAPEUTICS, INC.

By:

/s/

Shalabh Gupta

Chief Executive Officer

EX-99.1 — PRESS RELEASE OF UNICYCIVE THERAPEUTICS, INC. DATED MAY 12, 2026

EX-99.1

Filename: ea029027701ex99-1.htm · Sequence: 2

Exhibit 99.1

Unicycive

Therapeutics Announces First Quarter 2026 Financial Results and Provides Business Update

- U.S.

Food and Drug Administration (FDA) review of oxylanthanum carbonate (OLC) New Drug Application

(NDA) resubmission remains on track, with a Prescription Drug User Fee Act (PDUFA) target

action date of June 29, 2026

- Commercial

readiness activities continue in anticipation of the potential commercial launch of OLC

MOUNTAIN

VIEW, Calif., May 12, 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 first quarter ended March 31, 2026,

and provided a business update.

“As

we approach the June 29th PDUFA target action date, we remain optimistic about the potential approval of OLC and focused on preparations

for the subsequent launch of OLC,” said Shalabh Gupta, M.D., Chief Executive Officer of Unicycive. “Our ongoing dialogue

with the FDA during the review cycle has been constructive and timely. Uncontrolled hyperphosphatemia remains a significant health concern,

affecting nearly 75% of U.S. patients with chronic kidney disease who are undergoing dialysis. OLC has the potential to improve adherence

and phosphorus control with reduced pill burden, compared with currently available phosphate binders.”

Key

Highlights & Upcoming Milestones

● In

January 2026, the Company announced the FDA 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 December 2025 resubmission was based on progress

made by the third-party manufacturing vendor responsible for the drug product.

● In

preparation for a potential launch of OLC later this year, the Company continues to strengthen

its commercial infrastructure and advance market readiness initiatives. Unicycive’s

goal is to optimize patient access across all reimbursement settings and intends to provide

dedicated access and reimbursement support services for all patients through Unicycive’s

UniSource™ reimbursement hub.

Financial

Results for the Quarter Ended March 31, 2026

of May 11, 2026, unaudited cash, cash equivalents, and marketable securities

totaled $57.1 million. The Company believes that it has sufficient resources to fund planned operations into 2027.

Research

and Development (R&D) expenses were $1.6 million for the quarter ended March 31, 2026, compared to $2.2 million for the three months

ended March 31, 2025. The decrease in research and development expenses was primarily attributed to a decrease in drug development costs

as well as consulting and professional fees.

General

and Administrative (G&A) expenses were $6.8 million for the quarter ended March 31, 2026, compared to $5.8 million for the three

months ended March 31, 2025. The increase was primarily attributed to an increase in consulting, professional services, and labor costs.

Other

income (expense) was $(4.4) million expense for the quarter ended March 31, 2026, compared to $8.6 million income for the three months

ended March 31, 2025, attributed primarily to an increase in the fair value of the Company’s warrant liability.

Net

comprehensive income (loss) attributable to common stockholders, basic for the quarter ended March 31, 2026, was a $(12.8) million loss,

or $(0.54) per share of common stock, compared to $0.5 million income, or $0.04 per share of common stock, for the three months ended

March 31, 2025. Net comprehensive income (loss) attributable to common stockholders, diluted for the quarter ended March 31, 2026, was

a $(12.8) million loss, or $(0.54) per share of common stock, compared to a $(6.2) million loss, or $(0.50) per share of common stock,

for the three months ended March 31, 2025. The increased net loss for the quarter ended March 31, 2026, was attributed primarily to an

increase in the fair value of the Company’s warrant liability.

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)

December 31,

2025

March 31,

2026

(Unaudited)

Assets

Current

assets:

Cash

and cash equivalents

$ 29,198

$ 37,371

Prepaid

expenses and other current assets

7,692

8,959

Marketable

securities

12,071

17,215

Total

current assets

48,961

63,545

Right

of use asset, net

108

813

Property

and equipment, net

Total

Assets

$ 49,135

$ 64,406

Liabilities

and stockholders’ equity

Current

liabilities:

Accounts

payable

$ 383

$ 1,140

Accrued

liabilities

1,523

3,052

Warrant

liability

16,915

21,695

Operating

lease liability – current

117

598

Total

current liabilities

18,938

26,485

Operating

lease liability – long term

—

217

Total

Liabilities

18,938

26,702

Commitments

and contingencies (Note 7)

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, 2025,

and March 31, 2026; 2,265 Series A-2 Prime shares issued and outstanding at December 31, 2025, and March 31, 2026

—

Series

B-2 preferred stock, $0.001 par value per share - 50,000 Series B-2 shares authorized at December 31, 2025, and March 31, 2026; zero

Series B-2 shares issued and outstanding at December 31, 2025, and March 31, 2026

—

Preferred

stock, $0.001 par value per share – 10,000,000 shares authorized at December 31, 2025, and March 31, 2026; zero shares issued

and outstanding at December 31, 2025, and March 31, 2026

—

Common

stock, $0.001 par value per share – 400,000,000 shares authorized at December 31, 2025, and March 31, 2026; 22,114,245 and

25,237,782 shares issued and outstanding at December 31, 2025, and March 31, 2026, respectively

Accumulated

other comprehensive (loss) income

(1 )

Additional

paid-in capital

158,001

178,321

Accumulated

deficit

(127,825 )

(140,648 )

Total

Stockholders’ Equity

30,197

37,704

Total

Liabilities And Stockholders’ Equity

$ 49,135

$ 64,406

Unicycive

Therapeutics, Inc.

Statements

of Operations and Comprehensive Income (Loss)

(In thousands,

except for share and per share amounts)

(Unaudited)

Three Months

Ended

March 31,

2025

Three Months

Ended

March 31,

2026

Operating

expenses:

Research

and development

$ 2,171

$ 1,607

General

and administrative

5,818

6,830

Total

operating expenses

7,989

8,437

Loss

from operations

(7,989 )

(8,437 )

Other

income (expenses):

Interest

income

226

394

Interest

expense

(15 )

—

Change

in fair value of warrant liability

8,348

(4,780 )

Total

other income (expenses)

8,559

(4,386 )

Net

income (loss)

570

(12,823 )

Other

comprehensive loss:

Unrealized

loss on marketable securities, net

—

(1 )

Net

comprehensive income (loss)

$ 570

$ (12,824 )

Net

comprehensive income (loss) attributable to common stockholders, basic

$ 510

$ (12,824 )

Net

comprehensive (loss) attributable to common stockholders, diluted

$ (6,214 )

$ (12,824 )

Net

comprehensive income (loss) per share

Basic

$ 0.04

$ (0.54 )

Diluted

$ (0.50 )

$ (0.54 )

Weighted-average

shares outstanding used in computing net comprehensive income (loss) per share:

Basic

11,681,881

23,908,153

Diluted

12,383,477

23,908,153

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