Anthera Pharmaceuticals Reports 2010 Fourth Quarter and Year End Financial Results and Operational Update
Financial Results
Total operating expenses for the fourth quarter ended
Anthera ended the fourth quarter of 2010 with approximately
Recent Business Highlights and Upcoming Events:
Clinical
- In the fourth quarter the Company resumed the PEARL-SC Phase
2b clinical study. This study is expected to enroll approximately 540 subjects, utilizing up to 90 sites in 12 countries. PEARL-SC is examining the therapeutic benefit of A-623 in patients with systemic lupus erythematosus (lupus).The primary endpoint of the PEARL-SC study will be an SLE responder index. Details regarding the study can be found at http://www.clinicaltrials.gov/ct2/show/NCT01162681. - VISTA-16 site activations and patient enrollment are on-track for completion of the interim biomarker analysis. Patient enrollment has exceeded the 1000 patient threshold required for the analysis and we expect the data for the interim analyses to be submitted to an independent statistician in the coming weeks. The
statistician will examine four (4) predefined biomarkers of cardiovascular risk and one composite responder index including sPLA2, IL-6, CRP, LDL-C and the proportion of patients able to achieve an LDL-C < 70 and a CRP < 1. According to a predefined algorithm, the varespladib treatment arm must demonstrate an improvement versus placebo and meet various statistical treatment effects on these biomarkers for the study to continue. The VISTA-16 clinical study is designed to reduce inflammation and the risk of subsequent secondary Major Adverse Cardiovascular Events (MACE) in high-risk patients following an Acute Coronary Syndrome (ACS). Details regarding the study can be found at http://www.clinicaltrials.gov/ct2/show/NCT01130246. On
February 28, 2011 , at5 pm Eastern Time , Anthera will host a conference call to discuss the parameters and algorithm of the upcoming VISTA-16 interim biomarker analysis, including the expected timeline of the results. Conference details will be provided separately. - Subsequent to the end of the fourth quarter, the Data Safety Monitoring Board held a second review meeting for the VISTA-16 clinical study and provided a recommendation to continue the VISTA-16 clinical study without modification. A DSMB meeting will be scheduled to coincide closely with the upcoming biomarker analysis.
- The Company has submitted a protocol for A-001 with the
FDA based on promising data from a pre-specified interim review of our Phase 2 study. IMPACTS-2 (Investigation of the Modulation of Phospholipase in Acute ChesT Syndrome 2) is a 150 patient randomized, placebo-controlled study targeting the prevention of ACS in sickle cell patients.
Manufacturing
- In the fourth quarter the Company resolved certain instances of fractured A-623 drug product vials utilized in the PEARL-SC study. After extensive analysis, simulation and consultation with industry experts the root cause was determined, addressed, and the study resumed with sufficient drug supply on hand to complete PEARL-SC.
- The Company selected the Merck BioManufacturing Network in
Billingham, UK to manufacture the large-scale GMP clinical and pre-commercial supplies of A-623. The Company initiated pilot scale manufacturing of A-623 with the Merck BioManufacturing Network including the initial purification of intermediate products and small-scale fermentation.
Management
- Subsequent to the fourth quarter,
Larry Rosania joined Anthera as Vice-President of Global Regulatory Affairs and Compliance. Mr. Rosania brings over 35 years of experience, including his work on biologics such as Tysabri and MyoBloc. - In February,
Peter Thompson M.D . was appointed to Anthera's Board of Directors. Dr. Thompson is a venture partner with OrbiMed and is the founder and Managing Director ofStrategicon Partners , an investment and management services company. In 2009, Dr. Thompson retired as the Chief Executive Officer and Chairman ofTrubion Pharmaceuticals , which he co-founded. He is also the former Vice President and General Manager of Chiron Informatics and held various executive positions atBecton Dickinson .
About
Safe Harbor Statement
Any statements contained in this press release that refer to future events or other non-historical matters are forward-looking statements made pursuant to the safe harbor provisions of the Private Securities Litigation Reform Act of 1995. These include, but are not limited to, statements relating to the anticipated initiation of Anthera's clinical studies, anticipated duration and expected results of these studies, and the progression of Anthera's products through future stages of clinical development. These forward-looking statements are based on Anthera's expectations as of the date of this press release and are subject to certain risks and uncertainties that could cause actual results to differ materially as set forth in the Company's public filings with the
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ANTHERA PHARMACEUTICALS, INC. | ||||||||
A Development Stage Company | ||||||||
STATEMENT OF OPERATIONS | ||||||||
(unaudited) | ||||||||
Three Months Ended December 31, | Year Ended December 31, | |||||||
2010 | 2009 | 2010 | 2009 | |||||
OPERATING EXPENSE: | ||||||||
Research and development | $ 10,891,654 | $ 688,285 | $ 29,456,742 | $ 8,415,414 | ||||
General and administrative | 2,056,849 | 695,208 | 6,300,849 | 3,425,690 | ||||
Total operating expense | 12,948,503 | 1,383,493 | 35,757,591 | 11,841,104 | ||||
LOSS FROM OPERATIONS: | (12,948,503) | (1,383,493) | (35,757,591) | (11,841,104) | ||||
OTHER INCOME (EXPENSE): | ||||||||
Interest income and expense, net | (91,616) | (94,171) | (859,733) | (362,388) | ||||
Warrant mark to market adjustment | - | (3,796,491) | ||||||
Total other income (expense) | (91,616) | (94,171) | (4,656,224) | (362,388) | ||||
NET LOSS | $ (13,040,119) | $ (1,477,664) | $ (40,413,815) | $ (12,203,492) | ||||
Net loss per share--basic and diluted | $ (0.40) | $ (0.95) | $ (1.76) | $ (8.06) | ||||
Weighted-average number of shares used in per share calculation-- basic and diluted | 32,828,697 | 1,557,708 | 22,909,802 | 1,513,598 | ||||
ANTHERA PHARMACEUTICALS, INC. | ||||
A Development Stage Company | ||||
BALANCE SHEET DATA | ||||
(unaudited) | ||||
December 31, | December 31, | |||
Cash and cash equivalents | $ 40,029,972 | $ 3,803,384 | ||
Short term investments | $ 23,350,922 | |||
Total assets | $ 65,263,062 | $ 5,888,789 | ||
Total notes payable | $ -- | $ 13,129,877 | ||
Total warrant and derivative liabilities | $ -- | $ 406,130 | ||
Total current liabilities | $ 8,005,382 | $ 18,167,645 | ||
Deficit accumulated during development stage | $ (105,643,767) | $ (65,229,952) | ||
Total shareholders' equity (deficit) | $ 57,257,680 | $ (12,278,856) | ||
Common shares outstanding | 32,853,032 | 1,566,199 | ||
Preferred shares outstanding | -- | 8,146,308 | ||
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