Unicycive presents the main results of a market study conducted with nephrologists | Your money

Renazorb Product Profile Ranked Best in Class Phosphate Binder

Nephrologists Report High Prescribing Intent for Renazorb Awaiting FDA Approval

LOS ALTOS, Calif., July 20 10, 2022 (GLOBE NEWSWIRE) — Unicycive Therapeutics, Inc. (Nasdaq: UNCY), a clinical-stage biotechnology company developing therapies for patients with kidney disease, today announced results from primary market research conducted on behalf of the company by Reason Research, LLC. The study was a discrete-choice (“conjoint”) model analysis in which 100 US-based nephrologists were presented with various phosphate binder attributes, including efficacy, safety/tolerability, pill load, composition (calcium-based or calcium-free), and dosage form (chewable or swallowed), in a compromise methodology to determine comparative prescribing preferences for currently available phosphate binders and Renazorb®, Unicycive’s product under development.

Main research results:

Nephrologists estimate that they will prescribe Renazorb (pending FDA approval) to 34% of their market-leading dialysis patients requiring phosphate binder therapy. fewer pills/better patient compliance (60%), higher efficacy (33%), better tolerability (15%), less frequent administration (15%), new mode of action (7%), lower cost (5%), (unaided answers)

“This market research with nephrologists, the predominant prescribers of phosphate binders, provides strong validation of our belief in the best-in-class potential of the Renazorb product profile,” said Doug Jermasek, MBA, Executive Vice President, business strategy at Unicycive. “Nephrologists recognize that the biggest challenge they face in the management of hyperphosphatemia is poor patient adherence to their prescribed phosphate binders, primarily due to high pill counts. With its high phosphate binding capacity and reduced pill count, Renazorb may offer patients a more attractive alternative to current treatment options. These survey results give us additional confidence in the significant market opportunity for Renazorb. Going forward, we are focused on establishing our global commercial strategy and our launch plans for Renazorb, as uncontrolled hyperphosphatemia is a persistent medical issue for CKD patients worldwide.

The unmet need in hyperphosphatemia

Renazorb is intended to be taken as a tablet to be swallowed whole with meals. Patients with CKD typically have comorbidities, which often require them to adhere to strict medication schedules. Current phosphate binders such as Renagel/Renvela®, Phoslo® and Fosrenol® require patients to take multiple and/or larger pills (average 9 pills/day), in addition to other phosphate binder pills that they sometimes take. need to take, resulting in poor compliance with prescribed drug treatment. Potential strategies to improve adherence to phosphate binders in patients with ESRD include: (i) reduction in tablet size and number, (ii) improvement in palatability, and (iii) reduction in associated adverse effects, as published in a study by Covic and Rastogi in 2013. Therefore, Unicycive believes there is a strong need for a better phosphate binder, such as Renazorb, which has high and rapid phosphate binding, as well than a reduced pill load for better medication compliance.

The hyperphosphatemia treatment market exceeds $1 billion in the United States and is more than double worldwide. The Unicycive team is preparing to capitalize on this substantial opportunity by offering patients and providers an attractive treatment alternative.

Along with the clinical development program, the Company is focusing on its commercialization plans for Renazorb in the United States and globally. Unicycive is conducting extensive market research to inform its branding and market access strategy and comprehensive launch plan for Renazorb.

About Renazorb (Lanthanum Dioxycarbonate)

Renazorb is a next-generation lanthanum-based phosphate-binding agent using proprietary nanoparticle technology under development for the treatment of hyperphosphatemia in patients with chronic kidney disease (CKD). Its potential best-in-class profile has significant patient compliance advantages over currently available treatment options because it requires fewer and fewer pills per dose and is swallowed instead of be chewed.

About Hyperphosphatemia

Hyperphosphatemia is a serious medical condition that occurs in almost all patients with end-stage renal disease (ESRD). If left untreated, hyperphosphatemia leads to secondary hyperparathyroidism (SHPT), which then leads to renal osteodystrophy (a condition similar to osteoporosis and associated with significant bone disease, fractures, and bone pain); cardiovascular disease associated with hardening of the arteries and atherosclerosis (due to the deposition of excess calcium-phosphorus complexes in soft tissues). Importantly, hyperphosphatemia is independently associated with increased mortality in patients with chronic renal failure on dialysis. According to the clinical data available to date, more than 80% of patients show signs of cardiovascular calcification at the time they become dependent on dialysis.

Dialysis patients are already at increased risk of cardiovascular disease (due to underlying conditions such as diabetes and hypertension), and hyperphosphatemia further compounds this risk. Treatment of hyperphosphatemia aims to lower serum phosphate levels by two means: (1) restricting dietary phosphorus intake; and (2) using, daily and with each meal, oral phosphate-binding drugs that facilitate faecal elimination of dietary phosphate rather than its absorption from the gastrointestinal tract into the bloodstream.

Fosrenol is a registered trademark of Takeda Pharmaceuticals Company Ltd. Renagel and Renvela are registered trademarks of Genzyme, a Sanofi Phoslo company and Velphoro are registered trademarks of Fresenius Medical Care

About Unicycive Therapeutics

Unicycive Therapeutics is a biotechnology company developing new treatments for kidney disease. Unicycive’s lead drug, Renazorb, is a new 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, 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. Such statements may be identified by words such as “anticipate”, “believe”, “expect”, “estimate”. ” and “intend” or other similar terms or expressions that relate to Unicycive’s expectations, strategy, plans or intentions. These forward-looking statements are based on Unicycive’s current expectations and actual results could differ materially. Several factors could cause actual events to differ materially from those indicated by these forward-looking statements. These factors include, but are not limited to, clinical trials involving a long and expensive process with an uncertain outcome, and the results of past studies and trials may not be predictive of future trial results; our clinical trials may be suspended or terminated due to unexpected side effects or other safety risks that may prevent approval of our product candidates; risks related to business interruptions, including the COVID-19 coronavirus outbreak, which could seriously harm our financial condition and increase our costs and expenses; reliance on key personnel; substantial competition; uncertainties of patent protection and litigation; dependence on third parties; and risks related to the inability to obtain FDA clearances or approvals and non-compliance with FDA regulations. Actual results may differ materially from those indicated by these forward-looking statements due to a variety of important factors, including: uncertainties related to market conditions and other factors described in more detail in the section entitled “Risk Factors” of the annual report of Unicycive on Form 10-K for the fiscal year ended December 31, 2021 and other periodic reports filed with the Securities and Exchange Commission. All 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 statements, whether as a result of new information, future events or other.

Investor contacts:

[email protected] (650) 900-5470

Anne Marie Stern Investor Relations [email protected] 212-362-1200

SOURCE: Unicycive Therapeutics, Inc.

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