We are a biotechnology company dedicated to developing treatments for certain medical conditions. Two of our programs are focused on kidney disease: 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. During 2020, we 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 adults in the United States have CKD and, of these, about 2 million patients have CKD Stage 3-5, and around 400,000 patients with end-stage renal disease (ESRD) have hyperphosphatemia. In the European Union, around 20 million adults have CKD, more than 1 million are CKD Stage 3-5 patients, and about 180,000 patients with ESRD have hyperphosphatemia. The number of patients with ESRD is increasing steadily and is projected to reach between 971,000 and 1.26 million 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 priced its IPO on July 12, 2021, by slightly increasing the number of units to 5 million, up from 4.55 million in the prospectus, at $5 – the low end of its $5-to-$6 range – to raise $25 million. The company cut its IPO on June 30, 2021, to 4.55 million units at $5 to $6 each – down from 6.7 million units at $5.50 to $6.50 each. This followed the deal’s shift to a unit offering in an S-1/A filing dated June 21, 2021 – and those terms represented  a change from its initial filing for an IPO of 2.65  shares at $8.50 to $10.50 each.)