Multiple Data Presentations Support the Company’s Pipeline of Innovative Product Candidates aimed at Improving the Quality-of-Life for Patients Battling Kidney Disease

Independently Hosted Key Opinion Leader Panel to Highlight Potential of Company’s Product Candidates in Hyperphosphatemia and Acute Kidney Injury

LOS ALTOS, Calif., Oct. 26, 2022 (GLOBE NEWSWIRE) -- Unicycive Therapeutics, Inc. (Nasdaq: UNCY), a clinical stage biotechnology company developing therapies for patients with kidney disease, today announced that it will have a strong presence at the upcoming American Society of Nephrology’s (ASN) Kidney Week 2022 taking place November 3-6, 2022 in Orlando, Florida.

"We look forward to showcasing the growing body of clinical evidence in support of our innovative product candidates to improve the treatment paradigm for patients with kidney disease at this premier international nephrology conference,” said Shalabh Gupta, M.D., Chief Executive Officer of Unicycive. “Hyperphosphatemia continues to be a serious problem for end stage renal patients around the world, particularly as compliance with currently available phosphate binders is challenging and where we believe Renazorb’s unique product profile can improve adherence.   We are also looking forward to sharing compelling preclinical data from UNI-494, our novel drug candidate to reduce oxidative stress and restore mitochondrial function.”

Renazorb is an advanced phosphate binding agent utilizing proprietary nanoparticle technology being developed for the treatment of hyperphosphatemia. Unicycive has completed a clinical trial studying Renazorb in 32 healthy volunteers. In this study Renazorb was minimally absorbed to the systemic circulation and was safe and well-tolerated at doses up to 6000 mg/day. Renazorb significantly reduced urine phosphate excretion and significantly increased fecal phosphate excretion at doses at and above 3000 mg/day.

UNI-494 is a mitochondrial ATP sensitive potassium (mitoKATP) channel activator that is in development for the treatment of AKI. UNI-494 has been shown in preclinical models to improve tubular function in Acute Kidney Injury rat models and works by blocking the opening of mitochondrial permeability transition pores.

The following abstracts have been accepted for presentation at ASN’s Kidney Week:

In addition, Abstract #3764498, which is titled “Daily Medication Volume of Phosphate Binder Therapies,” was accepted for publication in ASN 2022’s Abstract Supplemental.

All abstracts for ASN’s Kidney Week 2022 are available via the ASN website (www.asn-online.org/education/kidneyweek) 

Separately, Ed Arce, Managing Director and Senior Biotechnology Analyst at H.C. Wainwright & Co., will host a Key Opinion Leader Panel on November 4, 2022. The panel will feature Ravindra L. Mehta, MD and Stuart M. Sprague, DO, FASN in a discussion about new treatment options in kidney disease. The panel is an invitation-only investor event. For those who are interested in participating in the panel discussion, please reach out to ea@unicycive.com. In addition, the event will be video archived and accessible on Events section of Unicycive’s website.

About the Key Opinion Leaders

Dr. Mehta is a Professor Emeritus of Medicine in the Department of Medicine at University of California San Diego where he directs the UCSD Masters in Clinical Research Program. He is an internationally recognized expert in the field of acute kidney injury (AKI) and continuous renal replacement therapies (CRRT). He chairs the annual International AKI and CRRT Conference in San Diego that is now in its 25th year. He chaired the International Society of Nephrology (ISN) Committee on AKI, is a founding member of the Acute Dialysis Quality Initiative (ADQI) and the Acute Kidney Injury network (AKIN), a member of the KDIGO Guidelines in AKI committee and served as the director of the ISN 0 by 25 initiative to eliminate preventable deaths from AKI by 2025. He has coordinated and led several multinational efforts for determining best approaches for managing AKI and CRRT. He has more than 200 original research publications, 100 reviews and book chapters. He has served on the NIH NIDDK study section and special emphasis panels and on editorial boards of the Journal of American Society of Nephrology, Kidney International and CJASN. He has been on the program committee of the ISN and contributed to the annual meetings of the American Society of Nephrology, National kidney Foundation and ISICEM. He has coordinated the development of consensus recommendations including the RIFLE and AKIN diagnostic and staging criteria for AKI. He has been recognized as one of the Best Doctors in San Diego and the US for several years. In 2008 he was recognized by the American Nephrologists of Indian Origin and in March 2009 he was elected as a Fellow of the Royal College of Physicians in the UK. He received the International Society of Nephrology (ISN) Bywaters Award for lifetime achievement in AKI in April 2011. He received the M.B.B.S. degree (1976) from the Government Medical School in Amritsar, India, and the M.D. (1979) and D.M. (1981) degrees from the Post Graduate Institute of Medical Education and Research in Chandigarh, India. He subsequently completed a nephrology fellowship at the University of Rochester in Rochester New York and obtained his boards in Internal Medicine (1986) and Nephrology (1988). He has been on the faculty at San Diego since 1988.

Dr. Sprague currently serves as the Chief of the Division of Nephrology and Hypertension at NorthShore University Health System and is a Clinical Professor of Medicine at the University of Chicago Pritzker School of Medicine. Previously, he was a Professor of Medicine at Northwestern University. Dr. Sprague has also been the recipient of a Fulbright Professorship. Dr. Sprague is internationally recognized in the field of bone and mineral metabolism, having authored over 200 peer-reviewed articles and spoken at numerous national and international professional meetings. Dr. Sprague has previously served as the Chairperson of the medical advisory board of the National Kidney Foundation of Illinois, the education committee of ASN, and the program committee of the National Kidney Foundation and ASN. He is currently a member of the leadership committee of the Global Bone and Mineral Initiative, an international scientific organization under the auspices of the National Kidney Foundation and European Renal Association to evaluate the diagnosis and management of bone, mineral, and cardiovascular disease in patients with chronic kidney disease.

He earned his undergraduate and medical degrees at Michigan State University in East Lansing, completed his internal medicine training at Rush-Presbyterian-St. Luke’s Medical Center in Chicago, and completed a nephrology clinical and research fellowship at the University of Chicago.

Dr. Sprague is on the editorial board of several prominent nephrology journals, is a reviewer for the NIH, has served as Chairperson for the Technical Expert Panel on mineral metabolism for CMS, and serves as a scientific consultant to industry.

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.

Investor Contact:
ir@unicycive.com
(650) 900-5470

Anne Marie Fields
Stern Investor Relations
annemarie.fields@sternir.com
212-362-1200

SOURCE: Unicycive Therapeutics, Inc.