cerus corp (CERS) Snapshot

Cerus Corporation announced that it has initiated patient enrollment in two European Phase III clinical trials for the INTERCEPT System for red blood cells (RBCs). One trial is being conducted for patients with acute anemia, and a separate trial is being conducted for patients with chronic anemia. RBCs are the most frequently transfused blood component, with approximately 85 million units transfused globally each year. Surgical patients with acute anemia, including cardiac surgery patients, are major recipients of RBC transfusions. Chronic anemia patients, such as those with thalassemia and sickle cell disease, are exposed to more blood transfusions than almost any other patient group, receiving as many as 1,500 RBC units over the course of a lifetime and thus at elevated risk for exposure to existing and emerging pathogens as well as bacterial contamination. Cerus is conducting these two Phase III clinical trials to support CE Mark registration. The first clinical trial is being conducted in elective cardiovascular surgery patients with acute anemia. Patients are randomized to receive seven days of support, beginning on the day of surgery, with either conventional or INTERCEPT RBCs. Target enrollment is 50 patients, and the primary endpoint is hemoglobin content per RBC unit transfused. Hemoglobin content was selected as the primary endpoint to evaluate the efficacy of the INTERCEPT Blood System as it is a key requirement for RBC components for transfusion per the European guidelines (EDQM) and will provide supporting data for CE Mark registration per the EU Medical Device Directive. The second clinical trial is being conducted in transfusion-dependent thalassemia major patients with chronic anemia. Patients are randomized into a crossover design and will receive transfusion support, separately in random sequence, with both conventional and INTERCEPT RBCs over approximately 12 months. Target enrollment is 70 patients, and the primary endpoints are hemoglobin usage (efficacy) and immunogenicity with repeat exposure (safety). Hemoglobin usage was selected as the primary efficacy endpoint as it represents the ability of transfused RBCs to oxygenate tissues, to persist in circulation, and to suppress endogenous erythropoiesis. This endpoint is clinically relevant because hemoglobin consumption may contribute to iron burden, an important complication for patients despite availability of chelation therapies.

Cerus Corporation announced that Aalborg University Hospital, Denmark, signed a five year project collaboration agreement for the INTERCEPT Blood System for platelets. The department of FBE Klinisk Immunologi at Aalborg University Hospital transfuses an estimated 2,200 platelet units annually to Region Nordjylland, representing approximately 6% of Denmark's platelet market.

Cerus Corporation reported unaudited consolidated earnings results for the first quarter ended March 31, 2013. For the quarter, the company reported product revenue of $9,733,000 against $8,691,000 for the same period a year ago. Continued growth in certain markets and continued placement of INTERCEPT illumination devices drove the revenue growth. Loss from operations was $4,960,000 against $4,572,000 for the same period a year ago. Loss from operations before income taxes was $10,201,000 against $8,799,000 for the same period a year ago. Net loss $10,252,000 or $0.17 basic and diluted per share against $8,834,000 or $0.17 basic and diluted per share for the same period a year ago. The increase in operating losses was driven by higher operating expenses incurred during the first quarter of 2013 compared to the first quarter of 2012, partially offset by increased product revenue and improved gross margins on product sales during the first quarter of 2013. Net losses were impacted by the mark-to-market adjustments of the company's outstanding warrants to fair value, which resulted in non-cash charges of $5.1 million during the first quarter of 2013 compared to $4.5 million during the first quarter of 2012. With regard to its ongoing sales growth in its current commercial markets, the company is on plan to reach its guidance of $41-$43 million in product revenue for the year.