Unicycive Announces Second Quarter Financial Results and Provides Business Update Advancing global commercial strategy for Renazorb to treat hyperphosphatemia On track to file regulatory submission to initi

Unicycive Announces Second Quarter Financial

Results and Provides Business Update

Advancing global commercial strategy for Renazorb

to treat hyperphosphatemia

On track to file regulatory submission to initiate

Phase 1 healthy volunteer study with UNI-494 in second half of 2022

LOS ALTOS, Calif., August 15, 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 second quarter ended June 30, 2022 and provided

Management Commentary

"We made considerable progress executing

our strategy throughout the first half of the year. Toward that end, we were delighted to initiate our pivotal bioequivalence trial of

Renazorb , which keeps us on track to complete the study around yearend and to file a New Drug Application (NDA) in 2023. In addition,

we signed our first global partnership for the marketing and commercialization of Renazorb in China with Lee's Pharmaceutical (HK)

Limited. This agreement provides Unicycive with non-dilutive funding, including a $1.0 million upfront payment received in August, which

underscores the potential for Renazorb as a best-in-class phosphate binder worldwide."

"We continue to develop and build compelling

scientific knowledge in support of UNI-494's unique mechanism of action to restore mitochondrial function in a variety of diseases

that are affected by mitochondrial dysfunction and look forward to regulatory filing to initiate the first-in-humans clinical program

for UNI-494 in the second half of the year," said Shalabh Gupta, M.D., Chief Executive Officer.

"We are adequately funded into 2023, which

is expected to allow us to advance Renazorb to NDA filing and to initiate the clinical trial for UNI-494. We continue to execute according

to our plan and remain excited about the opportunities ahead for Unicycive as we advance our clinical studies, expand access to Renazorb

around the world and further elucidate the potential of UNI-494's novel mechanism for the improvement of mitochondrial function

to treat a variety of diseases with large unmet medical needs and substantial market opportunities," concluded Dr. Gupta.

Renazorb (lanthanum dioxycarbonate)

Renazorb (lanthanum dioxycarbonate) 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

UNI-494 is a mitochondrial KATP channel

opener that reduces oxidative stress and restores mitochondrial function. UNI-494 is cleaved by esterase enzymes to form nicorandil, which

is the active metabolite. Nicorandil has extensive safety and efficacy data from multiple clinical trials including a 5000-patient randomized

controlled trial (IONA Study) and there is a consensus in the literature that the activation of KATP channel is the biological

basis for the observed cardio-protection and reno-protection in multiple clinical trials.

In preclinical studies, UNI-494 showed improvement

on the pharmacokinetic profile resulting in substantially higher exposure of nicorandil that may allow for less frequent and lower dosing.

Unicycive completed pharmacokinetic, safety pharmacology, genetic toxicity

and ADME studies. Repeat dose toxicity studies in two species are on track to be completed in the third quarter. The Company is on track

to file a regulatory submission to initiate the Phase I healthy volunteer study in the second half of 2022.

While Unicycive's initial focus is on acute kidney injury (AKI), UNI-494's novel mechanism of action may also hold promise

for indications in which mitochondrial dysfunction is implicated such as chronic kidney disease, liver disease (alcoholic hepatitis, hepatic

encephalopathy) and ophthalmic disease (dry AMD, macular degeneration etc).

UNI-494 is patent protected by issued patent(s) in the US and Europe

and a wide range patent applications worldwide.

Financial Results for Second Quarter Ended

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.

Forward-looking statement

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; risks related to business interruptions, including the outbreak of COVID-19 coronavirus,

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; 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, 2021, 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.

Stern Investor Relations

SOURCE: Unicycive Therapeutics, Inc.

Unicycive Therapeutics,

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

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Statements of Operations

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for share and per share amounts)