Firm is pushing on with U.S. commercialization of CE-marked Intercept plasma and platelet system.
Cerus hopes to raise about $21 million through a public offering of common stock and warrants, priced at $2.85 per unit. Each unit comprises one share of common stock and a warrant to purchase 0.5 of a share of common stock. Each warrant will have an exercise price of $3.20 per share and be exercisable six months after the date of issuance, for up to five years. Cerus says net proceeds from the offering are projected to be about $19.7 million, after the deduction of underwriting discounts and commissions, but before legal and other offering expenses.
Cerus is commercializing its pathogen inactivation technology, known as the Intercept Blood System, for platelets, plasma, and red blood cells. The technology is designed to reduce the risk of transfusion-transmitted diseases by inactivating a broad range of pathogens, including viruses, bacteria, and parasites, which may be present in donated blood intended for transfusion.
Just last week the firm reported the award of two cash grants totaling approximately $489,000 under the U.S. Government’s Qualifying Therapeutic Discovery Project (QTDP) program. The funding will be used to support the development of the Intercept Blood System for platelets and red blood cells.
Two separate Intercept systems have been developed. THE CE-marked platform for platelets and plasma exploits Cerus’ Helinx technology and uses amotosalen HCl to block the replication of DNA and RNA and prevent the proliferation of susceptible pathogens. The approach essentially crosslinks the nucleic acids present in susceptible pathogens, blocking replication, and preventing their proliferation, Cerus explains. The treatment process in addition simultaneously inactivates donor leukocytes that can pose risks for transfusion recipients. Cerus says over 450,000 Intercept platelet and plasma kits have been shipped to date, and the technology has been used clinically in Europe, Russia, the Middle East, Asia, and in selected countries in other regions around the world. The platelet and plasma systems are in Phase III trials in the United States.
The system for red blood cell pathogen inactivation uses a similar treatment process, and is based on a molecule known as S-303 that forms crosslinks when activated by a change in pH that occurs when red blood cells are added to the disposable set. It has yet to be approved in any market. Phase III testing of the original red blood cell system highlighted potential issues relating to the development of antibodies against the treated red blood cells, even though the primary endpoints were met. The system was subsequently redesigned to minimize the antibody issue, and Cerus successfully completed a small Phase I clinical trial with the modified red blood cell system at two sites in the U.S. early in 2010. The firm then said it would wait to raise additional financing before starting another Phase III trial. Additional funding for the red blood cell system was awarded in September, through a $1.4 million grant from the U.S. Department of Defense.
Cerus holds worldwide rights to commercialize the Intercept system. Under a restructured agreement with Baxter the firm is now directly responsible for the worldwide development and commercialization of the system, excluding certain Asian countries, which have been licensed to BioOne. Cerus has separately established a subsidiary based in The Netherlands to market and sell the Intercept platelet and plasma systems in Europe, Russia, the Middle East, and in selected countries in other regions around the world. The firm has established distributor agreements for Intercept in Spain, Portugal, Chile, Italy, Greece, Turkey, Kuwait, Russia, Poland, and other CIS countries.