Anthera Pharmaceuticals Reports 2015 First Quarter and Operational Update
Completed Interim Analysis from Phase 3 Trial with Blisibimod for Systematic Lupus Erythematosus
Completed Interim Analysis from Phase 2/3 Trial with Blisibimod for IgA Nephropathy
Increased Cash Position by $43 Million Through Equity Investment by Zenyaku and Equity Offering
Received $3 Million Research Award from Cystic Fibrosis Foundation Therapeutics for Phase 3 Development of Sollpura (liprotamase)
HAYWARD, Calif., May 11, 2015 (GLOBE NEWSWIRE) -- Anthera Pharmaceuticals, Inc. (ANTH) today announced financial results and an operational update for the first quarter ended March 31, 2015.
Net loss for the quarter ended March 31, 2015 was $7.7 million, compared to $7.9 million for the same period in 2014.
Research and development expense for the quarter ended March 31, 2015 was $6.0 million, compared to $5.8 million for the same period in 2014. The increase in research and development expense was primarily due to expansion activities for our BRIGHT-SC IgA nephropathy study and manufacturing activities for our upcoming Phase 3 SOLUTION study with liprotamase.
General and administrative expense for the quarter ended March 31, 2015 was $1.9 million, compared to $1.8 million for the same period in 2014.
Non-operating expense for the quarter ended March 31, 2015 was reduced from $0.3 million to $3,000 mainly as a result of a reduction in interest expense driven by our elimination of all debt financing arrangements in the fourth quarter of 2014.
As of March 31, 2015, we had cash and cash equivalents of $41.6 million, compared to $2.6 million as of December 31, 2014. The increase in our cash balance was mainly driven by total financing proceeds of $45.5 million received from the sale of our common stock through a public offering for $26.9 million, $11.6 million from the sale of common stock through an at-the-market offering and $7.0 million from an equity investment by our collaborative partner, Zenyaku, in the first quarter of 2015.
First Quarter Operational Update:
Sollpura(TM) (liprotamase)
Manufacturing activities for liprotamase progressed on schedule with respect to both capsule and sachet products. Sachet formulation development was substantially completed and pilot-scale feasibility was executed demonstrating manufacturability.
In March 2015, we received a research award from Cystic Fibrosis Foundation Therapeutics Inc. of up to $3 million to support the manufacturing and clinical development of our novel pancreatic enzyme replacement therapy, Sollpura(TM) (liprotamase). Cystic Fibrosis Foundation Therapeutics is a non-profit affiliate of the Cystic Fibrosis Foundation which supports and governs activities related to cystic fibrosis drug discovery through the many stages of drug development and clinical evaluation.
Blisibimod -- Systemic Lupus Erythematosus
In February 2015, we modified the primary efficacy endpoint of CHABLIS-SC1 from the SRI-8 responder index to SRI-6 (previously a secondary endpoint of the study). The SRI (SLE Responder Index) is a recognized endpoint by the FDA for previously approved therapeutics. The change in primary efficacy endpoint was based on our Scientific Advisory Board's evaluation of published clinical data from other recent lupus studies with BAFF inhibitors in which the outcomes as measured using SRI-6 endpoint were more consistent. Subsequent to the amendment of the primary endpoint, an independent un-blinded statistician conducted an interim analysis of CHABLIS-SC1 based on the proportion of responders to the SRI-6 at a pre-specified time point. Based on this analysis, the un-blinded statistician recommended the study to continue to completion as planned. We anticipate full enrollment of 400 patients in the CHABLIS-SC1 trial to be completed this year with top-line efficacy data expected in the second half of 2016.
Blisibimod -- IgA Nephropathy
In March 2015, an interim analysis of the BRIGHT-SC study was conducted by an independent un-blinded statistician, who evaluated several important biomarkers of renal disease in IgA nephropathy amongst patients who had completed at least 8 weeks of treatment. Based on the results of the interim analysis, it was recommended that the BRIGHT-SC trial should continue to completion. Following this outcome, in collaboration with our partner Zenyaku, we are expanding the number of BRIGHT-SC worldwide clinical sites.
