UNICYCIVE THERAPEUTICS, INC.
We are a biotechnology company dedicated to developing treatments for certain medical conditions. Currently, two of our programs are focused on kidney disease that we believe have the potential to offer medical benefit. As we grow the Company and build our team, we intend to focus on identifying medical conditions within and outside of kidney disease. Our current development programs are focused on the development of two novel therapies: Renazorb, for treatment of hyperphosphatemia in patients with chronic kidney disease, and UNI 494, for treatment of acute kidney injury (AKI). Renazorb and UNI 494 were initially developed by, and licensed to us from, Spectrum Pharmaceuticals (“Spectrum”) and Sphaera Pharmaceuticals, respectively. Spectrum conducted a Phase 1 clinical trial with Renazorb in 2012 prior to the grant of our license in 2018. Sphaera conceived, and performed initial characterization of, various potential pro-drug linkers, including the initial patent application, and performed some initial physiochemical characterization and preliminary animal pharmacokinetic studies. As discussed herein, during 2020 we have conducted preclinical studies with UNI 494.
Chronic kidney disease (CKD) is the gradual loss of kidney function that can get worse over time leading to lasting damage. Our initial focus is on developing drugs and getting them approved in the U.S., and then to partner with global biopharmaceutical companies in the rest of the world. According to estimates by The Centers for Disease Control and Prevention (CDC) in 2019, 37 million (approximately 15%) adults in the United States have CKD and, of these, approximately 2 million patients with CKD stage 3-5, and around 400 thousand patients with end-stage renal disease (ESRD) have hyperphosphatemia. In the European Union (EU), around 20 million (approximately 8%) adults have CKD, more than 1 million CKD stage 3-5 patients, and approximately 180 thousand patients with ESRD have hyperphosphatemia. The number of patients with ESRD is increasing steadily and is projected to reach between 971,000 and 1,259,000 in 2030.
AKI is a sudden episode of kidney failure or kidney damage (within the first 90 days of injury). After 90 days, the patient is considered to have progressed into CKD. AKI affects over 2 million U.S. patients and costs the healthcare system over $9 billion per year. AKI kills more than 300,000 patients per year in the U.S. and is caused by multiple etiologies.
Our business model is to license technologies and drugs and pursue development, regulatory approval, and commercialization of those products in global markets. Many biotechnology companies utilize similar strategies of in-licensing and then developing and commercializing drugs. We believe, however, that our management team’s broad network, expertise in the biopharmaceutical industry, and successful track record gives us an advantage in identifying and bringing these assets into our Company at an attractive price with limited upfront cost.
(Note: Unicycive Therapeutics amended its IPO on June 21, 2021, to become a unit offering: 6.7 million units at $5.50 to $6.50 each to raise $40.2 million, if priced at the mid-point. Each unit consists of one share of common stock and one-half warrant to buy one share of common stock at an exercise price equal to 125 percent of the IPO price, according to the S-1/A filing dated June 21, 2021. The deal previously consisted of 2.65 million shares at $8.50 to $10.50 each to raise $25.08 million. The deal initially appeared on the pricing schedule for the week of June 14th.)
|Address||5150 El Camino Real, Suite A-32, Los Altos, CA 94022|
|Phone Number||(650) 351-4495|
|View Prospectus:||UNICYCIVE THERAPEUTICS, INC.|
|Revenues||$0 mil (last 12 months)|
|Net Income||$-2.26 mil (last 12 months)|
|Price range||$5.50 - $6.50|
|Est. $ Volume||$40.2 mil|
|Manager / Joint Managers||Roth Capital Partners|
|CO-Managers||EF Hutton (formerly Kingswood Capital Markets)|
|Expected To Trade:||6/25/2021|
|Quiet Period Expiration Date:||Available only to Subscribers|
|Lock-Up Period Expiration Date:||Available only to Subscribers|
|SCOOP Rating||Available only to Subscribers|
|Rating Change||Available only to Subscribers|