Delaware | 001-34637 | 20-1852016 | ||
(State or Other Jurisdiction of Incorporation) |
(Commission File Number) | (I.R.S. Employer Identification No.) |
25801 Industrial Boulevard, Suite B, Hayward, California | 94545 | |
(Address of Principal Executive Offices) | (Zip Code) |
o | Written communications pursuant to Rule 425 under the Securities Act (17 CFR 230.425) |
o | Soliciting material pursuant to Rule 14a-12 under the Exchange Act (17 CFR 240.14a-12) |
o | Pre-commencement communications pursuant to Rule 14d-2(b) under the Exchange Act (17 CFR 240.14d-2(b)) |
o | Pre-commencement communications pursuant to Rule 13e-4(c) under the Exchange Act (17 CFR 240.13e-4(c)) |
Item 2.02 | Results of Operations and Financial Condition. |
Item 9.01 | Financial Statements and Exhibits. |
Exhibit No. | Description | |
99.1 | Press Release, dated May 3, 2011 |
Anthera Pharmaceuticals, Inc. |
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Date: May 3, 2011 | By: | /s/ Christopher P. Lowe | ||
Christopher P. Lowe | ||||
Chief Financial Officer | ||||
Exhibit No. | Description | |
99.1 | Press Release, dated May 3, 2011 |
| Enrollment and site initiations continue according to the Companys estimated timelines in the PEARL-SC study. Active enrollment is underway in the following countries: United States, Mexico, Peru, Chile, the Philippines, Argentina and Colombia. PEARL-SC is examining the therapeutic benefit of A-623, which utilizes a subcutaneous formulation and modulates both soluble and membrane-bound BAFF in patients with systemic lupus erythematosus (lupus). The primary endpoint of the PEARL-SC study is an SLE responder index (SRI). Details regarding the study can be found at http://www.clinicaltrials.gov/ct2/show/NCT01162681. |
| The PEARL-SC open label extension protocol has been submitted to FDA. This would allow Anthera to capture important long term safety data and optimize enrollment by giving study subjects an option to continue participation on active therapy beyond the PEARL-SC duration. |
| In the Phase 3 VISTA-16 study, enrollment surpassed the 1000 patient threshold during the first quarter, triggering a pre-defined, blinded biomarker analysis conducted by an independent statistician. The statistician examined four predefined biomarkers of cardiovascular risk and one composite responder index including sPLA2, IL-6, CRP, LDL-C and a composite analysis comparing the proportion of patients achieving an LDL-C < 70 and a CRP < 1. Subsequent to the end of the first quarter, the Company announced a favorable outcome from the biomarker analysis. 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 ACS. Details regarding the study can be found at http://www.clinicaltrials.gov/ct2/show/NCT01130246. The next substantial review of clinical safety and efficacy data is planned once 50 percent of the anticipated primary endpoints have occurred. At this review the DSMB will conduct the first prescribed statistical efficacy review of the primary endpoint. |
| The Company initiated pilot scale manufacturing of A-623 and has established process parameters for the purification of small-scale fermentation. |
| The Company has submitted the first of three A-623 Comparability Plans to the US FDA a key step in ensuring adequate drug supply for Phase 3 and expanded indications. |
| Peter Thompson, M.D., was appointed to Antheras Board of Directors during the quarter. Dr. Thompson is a venture partner with OrbiMed and is the founder and Managing Director of Strategicon Partners, an investment and management services company. In 2009, Dr. Thompson retired as the Chief Executive Officer and Chairman of Trubion Pharmaceuticals, which he co-founded. He is also the former Vice President and General Manager of Chiron Informatics and held various executive positions at Becton Dickinson. |
Three Months Ended March 31, | ||||||||
2011 | 2010 | |||||||
OPERATING EXPENSE: |
||||||||
Research and development |
$ | 16,316,758 | $ | 5,241,814 | ||||
General and administrative |
2,339,882 | 1,224,110 | ||||||
Total operating expense |
18,656,640 | 6,465,924 | ||||||
LOSS FROM OPERATIONS: |
(18,656,640 | ) | (6,465,924 | ) | ||||
OTHER INCOME (EXPENSE): |
||||||||
Other expense and interest income, net |
90,935 | (4,637,868 | ) | |||||
Total other income (expense) |
90,935 | (4,637,868 | ) | |||||
NET LOSS |
$ | (18,565,705 | ) | $ | (11,103,792 | ) | ||
Net loss per sharebasic and diluted |
$ | (0.56 | ) | $ | (0.83 | ) | ||
Weighted-average number of shares used in
per share calculation basic and diluted |
32,895,152 | 13,344,231 | ||||||
March 31, | December 31, | |||||||
2011 | 2010 | |||||||
Cash and cash equivalents |
$ | 66,557,789 | $ | 40,029,972 | ||||
Short term investments |
$ | 11,982,185 | $ | 23,350,922 | ||||
Total assets |
$ | 81,445,375 | $ | 65,263,062 | ||||
Accounts payable |
$ | 7,664,486 | $ | 3,791,693 | ||||
Accrued clinical trial expense |
$ | 8,159,476 | $ | 3,136,786 | ||||
Total current liabilities |
$ | 16,770,711 | $ | 8,005,382 | ||||
Total notes payable |
$ | 23,719,801 | $ | | ||||
Deficit accumulated during development stage |
$ | (124,209,472 | ) | $ | (105,643,767 | ) | ||
Total shareholders equity |
$ | 40,954,863 | $ | 57,257,680 | ||||
Common shares outstanding |
32,909,914 | 32,853,032 |