Unicycive Announces Full Year 2021 Financial Results and Provides Business Update On track to initiate clinical bioequivalence study of Renazorb to treat hyperphosphatemia in healthy volunteers in first hal

Unicycive Announces Full Year 2021 Financial

Results and Provides Business Update

On track to initiate clinical bioequivalence

study of Renazorb to treat hyperphosphatemia in

healthy volunteers in first half of 2022

Plans to initiate Phase 1 study for UNI-494

in second half of 2022

LOS ALTOS, Calif., March 31, 2022 -- 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, 2021 and provided

"The considerable progress we made throughout

2021 puts us in a strong position to execute on our strategy to advance our clinical development programs to address two important renal

diseases where current treatment options are suboptimal," said Shalabh Gupta, M.D., Chief Executive Officer. "Central

to our progress was the confirmatory regulatory guidance we received from the U.S. Food and Drug Administration (FDA) regarding the path

to marketing approval for our lead product candidate, Renazorb. We are delighted the FDA affirmed its guidance to enable us to pursue

the 505(b)2 regulatory pathway, which we believe will significantly reduce the clinical timelines and expense for bringing this enhanced

hyperphosphatemia therapy to chronic kidney disease patients seeking new treatment options for this continually challenging condition.

"We have an exciting year ahead at Unicycive

as we advance our late-stage program in hyperphosphatemia, initiate first-in-human studies of our earlier stage program with UNI-494 in

Acute Kidney Injury and strive to achieve a number of potentially value-creating milestones," concluded Dr. Gupta.

Renazorb (lanthanum dioxycarbonate)

Renazorb is a next-generation lanthanum-based

phosphate binding agent utilizing proprietary nanoparticle technology being developed for the treatment of hyperphosphatemia in patients

with chronic kidney disease (CKD). Its potential best-in-class profile has meaningful patient adherence benefits over currently available

treatment options as it requires smaller and fewer number of pills per dose and is swallowed instead of chewed.

Unicycive is preparing a clinical bioequivalence

study to be performed in healthy volunteers in order to submit a 505(b)(2) NDA to the FDA. The Company is making ongoing progress with

this program and has submitted the BE study protocol to the FDA. Unicycive has selected a CRO that will conduct the BE study and remains

on track to initiate this study in the second quarter of 2022, with a goal to complete the study by the end of 2022.

The Company identified a preclinical CRO and initiated

the work for the 6-month toxicology study that is required for the submission of the Renazorb NDA and this study remains on track to be

completed in time for NDA submission.

Unicycive is looking forward to the presentation

of preclinical and clinical data at the National Kidney Foundation Spring Meeting that support the potential safety and efficacy of Renazorb

to treat hyperphosphatemia in chronic kidney disease patients.

The hyperphosphatemia treatment market exceeds

one billion dollars in the U.S. and more than double that in the rest of the world. The Unicycive team is preparing to capitalize on this

substantial opportunity by offering patients and providers an attractive treatment alternative. In tandem with the clinical development

program, the Company is focused on its commercialization plans for Renazorb in the U.S. and around the world. Unicycive is conducting

important market research to inform its brand and market access strategy and comprehensive launch plan for Renazorb.

UNI-494 is a patent-protected new chemical entity

in late preclinical development for the treatment of acute kidney injury.

Unicycive continues to make progress toward advancing

UNI-494 into the clinic and, toward that end, has completed chemical synthesis for animal studies and has initiated preclinical in

vivo studies to support an Investigational New Drug submission expected in mid-2022. The Company plans to initiate a first-in-humans

Phase 1 study of UNI-494 in the third quarter of 2022.

Financial Results for the Year Ended December

Research and development expenses for the full

year ended December 31, 2021 were $6.1 million, compared to $1.0 million for the same period in 2020. This increase was primarily attributable

to a one-time $2.2 million increase in non-cash expense from the issuance of common stock to our Renazorb licensor. Development costs

increased $1.4 million from the prior year.

General and administrative expenses for the fiscal

year ended 2021 were $2.9 million, compared to $1.0 million for the year ended 2020. This increase was primarily attributable to an increase

of $0.7 million in insurance expense for directors and officers.

Net loss for the 12-month period ended December

31, 2021 was $10.0 million, or $0.86 per share of common stock, compared to a net loss of $2.3 million, or $0.27 per share of common stock,

for the same 12-month period in 2020. This increase was primarily attributable to non-cash stock issuance expense in the current period.

As of December 31, 2021, cash and cash equivalents

totaled $16.6 million.

About Unicycive Therapeutics

Unicycive Therapeutics is a biotechnology company

developing novel treatments for kidney diseases. Unicycive's lead drug, Renazorb, is a novel phosphate binding agent being developed

for the treatment of hyperphosphatemia. UNI-494 is a patent-protected new chemical entity in late preclinical development for the treatment

of acute kidney injury. For more information, please visit www.unicycive.com.

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