Form 8-K

8-K — Unicycive Therapeutics, Inc.

Accession: 0001213900-26-088061

Filed: 2026-08-12

Period: 2026-08-12

CIK: 0001766140

SIC: 2834 (PHARMACEUTICAL PREPARATIONS)

Item: Results of Operations and Financial Condition

Item: Financial Statements and Exhibits

Documents

8-K — ea0301699-8k_unicycive.htm (Primary)

EX-99.1 — PRESS RELEASE OF UNICYCIVE THERAPEUTICS, INC. DATED AUGUST 12, 2026 (ea030169901ex99-1.htm)

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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): August 12, 2026

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 ☒

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.

August 12, 2026, Unicycive Therapeutics, Inc. issued a press release announcing its financial results for the second quarter ended June

30, 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 August 12, 2026.

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:

August 12, 2026

UNICYCIVE THERAPEUTICS, INC.

By:

/s/ Shalabh Gupta

Shalabh Gupta

Chief Executive Officer

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

EX-99.1

Filename: ea030169901ex99-1.htm · Sequence: 2

Exhibit 99.1

Unicycive

Therapeutics Announces Second Quarter 2026 Financial Results and Provides Business Update

- Company expects to resubmit New Drug Application (NDA) for oxylanthanum carbonate (OLC) assuming completion of successful inspection of third-party manufacturing vendor

- FDA has assigned a facility inspection to third-party manufacturing vendor of OLC

- As of June 30, 2026, unaudited cash, cash equivalents, and marketable securities totaled $61.4 million, with expected runway into 2027

MOUNTAIN

VIEW, Calif., August 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 second quarter ended June

30, 2026, and provided a business update.

“We

are focused on securing approval of oxylanthanum carbonate (OLC) and remain confident in the efficacy and safety of OLC and in its potential

to improve care for patients with hyperphosphatemia on dialysis,” said Shalabh Gupta, M.D., Chief Executive Officer of Unicycive.

“The latest update from our third-party manufacturing vendor is that the U.S. Food and Drug Administration (FDA) has assigned a

facility inspection. This marks a positive step forward, and our dialogue with the FDA on OLC labeling and packaging has been productive

and continuous throughout this process. We are optimistic about a successful inspection of the third-party manufacturing facility, which

would enable us to promptly resubmit the NDA. In the meantime, we are well positioned to launch OLC as quickly as possible following

potential approval, and we are utilizing this time to continue to expand market awareness in preparation for the commercial success of

OLC.”

Key

Highlights & Upcoming Milestones

● In

June, the Company received a Complete Response Letter (CRL) from the FDA regarding the resubmitted

NDA for OLC for the treatment of hyperphosphatemia in patients with chronic kidney disease

on dialysis. The CRL cites the same third-party manufacturing deficiencies identified in

a previous CRL issued in June 2025. The FDA has not raised any concerns regarding clinical

efficacy or safety data, and no additional data was requested from the Company.

● The

Company’s third-party vendor has received written notification from the FDA that the

facility inspection has been assigned, and the Company plans to provide an update following

completion of the FDA inspection.

● In

preparation for the potential launch of OLC, the Company continues to advance its commercial

readiness initiatives. Unicycive is focused on optimizing patient access across all reimbursement

settings and plans to support patients with dedicated access and reimbursement services through

its UniSource™ reimbursement hub.

● The

Company will also engage with the patient and clinical community at several medical meetings

during the third quarter, including the 51st Annual American Association of Kidney Patients

National Patient Meeting (September 11–13, Little Rock, Arkansas) and the 2026 Renal

Healthcare Association Annual Conference (September 23–26, Savannah, Georgia).

Financial

Results for the Quarter Ended June 30, 2026

Research

and Development (R&D) expense was $2.8 million for the quarter ended June 30, 2026, compared to $1.8 million for the three months

ended June 30, 2025. The increase was primarily driven by a $0.9 million increase in non-cash stock-based compensation, and an increase

in consulting and professional fees of $0.1 million.

General

and Administrative (G&A) expense was $7.4 million for the quarter ended June 30, 2026, compared to $5.2 million for the three months

ended June 30, 2025. The increase was primarily driven by a $1.4 million increase in non-cash stock-based compensation as well as an

increase of $0.3 million in other labor costs. There was also an increase of $0.4 million related to commercial launch preparation.

Other

income (expense) was $8.4 million for the quarter ended June 30, 2026, compared to $0.5 million income for the three months ended June

30, 2025, attributed primarily to an increase in the fair value of the Company’s warrant liability.

Net

loss attributable to common stockholders, basic and diluted, for the quarter ended June 30, 2026, was $(1.7) million, or $(0.06) per

share of common stock, compared to $(6.5) million loss, or $(0.52) per share of common stock, for the three months ended June 30, 2025.

The decreased net loss for the quarter ended June 30, 2026, was attributed primarily to a decrease 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 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:

Unicycive

Therapeutics

media@unicycive.com

SOURCE: Unicycive

Therapeutics, In

As of

December 31,

2025

As of

June 30,

2026

(Unaudited)

Assets

Current assets:

Cash and cash equivalents

$ 29,198

$ 44,185

Prepaid expenses and other current assets

7,692

9,895

Marketable securities

12,071

17,240

Total current assets

48,961

71,320

Right of use asset, net

108

668

Property and equipment, net

Total assets

$ 49,135

$ 72,029

Liabilities and stockholders’ equity

Current liabilities:

Accounts payable

$ 383

$ 2,234

Accrued liabilities

1,523

2,136

Warrant liability

16,915

13,718

Operating lease liability - current

117

616

Total current liabilities

18,938

18,704

Operating lease liability – long term

Total liabilities

18,938

18,759

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 June 30, 2026; 2,265 and zero Series A-2 Prime shares issued and outstanding at December 31, 2025, and June 30, 2026, respectively

Series B-2 preferred stock, $0.001 par value per share – 50,000 Series B-2 shares authorized at December 31, 2025, and June 30, 2026; zero Series B-2 shares issued and outstanding at December 31, 2025, and June 30, 2026

Preferred stock, $0.001 par value per share – 10,000,000 shares authorized

at December 31, 2025, and June 30, 2026; zero shares issued and outstanding at December 31, 2025, and June 30, 2026

Common stock, $0.001 par value per share – 400,000,000 shares authorized at December 31, 2025, and June 30, 2026; 22,114,245 and 27,855,257 shares issued and outstanding at December 31, 2025, and June 30, 2026, respectively

Accumulated other comprehensive loss

(1 )

(23 )

Additional paid-in capital

158,001

195,635

Accumulated deficit

(127,825 )

(142,370 )

Total stockholders’ equity

30,197

53,270

Total liabilities and stockholders’ equity

$ 49,135

$ 72,029

Three Months Ended

June 30,

2025

2026

Operating expenses:

Research and development

1,750

2,788

General and administrative

5,213

7,352

Total operating expenses

6,963

10,140

Loss from operations

(6,963 )

(10,140 )

Other income (expenses):

Interest income

155

441

Interest expense

(13 )

Change in fair value of warrant liability

374

7,977

Total other income (expenses)

516

8,418

Net loss

(6,447 )

(1,722 )

Other comprehensive loss:

Unrealized loss on marketable securities, net

(29 )

Net comprehensive loss

$ (6,447 )

$ (1,751 )

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

$ (0.52 )

$ (0.06 )

Weighted-average shares outstanding used in computing net loss per share

12,302,059

26,917,266

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