Anthera Pharmaceuticals Reports 2014 Second Quarter Financial Results and Operational Update
Net loss for the three months ended
Net loss for the six months ended
As of
Second Quarter Operational Update:
Clinical
Blisibimod for the treatment of Systemic Lupus Erythematosus (CHABLIS-SC1)
Our Phase 3 lupus clinical study, CHABLIS-SC1, is recruiting at 12 countries in
We have submitted the final protocol to the US FDA for our second lupus registration study, CHABLIS-SC2. This second study is expected to enroll up to 400 patients with active lupus, including patients with glomerulonephritis who may have a previous diagnosis of Lupus Nephritis. Consistent with the CHABLIS-SC1 clinical study, the primary endpoint of this second study will be the SRI-8 response. These two pivotal studies will form the basis of a submission for blisibimod as a treatment for patients with active lupus.
Blisibimod for the treatment of IgA Nephropathy (BRIGHT-SC)
The BRIGHT-SC clinical study is currently recruiting patients with a biopsy-proven diagnosis of IgA nephropathy in seven countries in
In
We believe blisibimod and the BRIGHT-SC clinical study represent the only therapeutic approach intended to specifically target the underlying biological problem of IgA nephropathy - immunoglobulin complex formation. Unlike other potential anti-inflammatory treatments for IgA nephropathy, blisibimod's specific targeting of B cells and plasma cells may safely reduce IgA and IgG production and inflammation and potentially halt further damage to the kidney - key to improving clinical outcomes.
To date, baseline characteristics of patients enrolled in the BRIGHT-SC study are consistent with our objectives to enroll patients with a biopsy diagnosis of IgA nephropathy, high levels of proteinuria, and kidney function indicative of progressive kidney disease. Additional information and publications from the BRIGHT-SC clinical study can be found at http://www.anthera.com/studies_bright-sc.htm.
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CONSOLIDATED STATEMENTS OF OPERATIONS (in thousands, except share and per share data) (unaudited) | ||||||||||||
Three months ended June 30, |
Six months ended | |||||||||||
2014 |
2013 |
2014 |
2013 | |||||||||
Operating expenses: |
||||||||||||
Research and development |
$ |
5,279 |
$ |
5,265 |
$ |
11,044 |
$ |
10,194 | ||||
General and administrative |
1,586 |
1,688 |
3,430 |
3,660 | ||||||||
Total operating expenses |
6,865 |
6,953 |
14,474 |
13,854 | ||||||||
Loss from operations |
(6,865) |
(6,953) |
(14,474) |
(13,854) | ||||||||
Other Income (expense): |
||||||||||||
Other income (expense) - net |
(31) |
(6) |
(79) |
19 | ||||||||
Interest expense |
(360) |
(1,322) |
(619) |
(2,026) | ||||||||
Total other (expense) - net |
(391) |
(1,328) |
(698) |
(2,007) | ||||||||
Net loss |
$ |
(7,256) |
$ |
(8,281) |
$ |
(15,172) |
$ |
(15,861) | ||||
Net loss per basic and diluted: |
$ |
(0.34) |
$ |
(0.43) |
$ |
(0.73) |
$ |
(0.92) | ||||
Weighted-average number of shares used in per share calculation-basic and diluted |
21,479,386 |
19,059,130 |
20,805,162 |
17,297,098 | ||||||||
| ||||||
BALANCE SHEET DATA | ||||||
(in thousands, except share data) | ||||||
(unaudited) | ||||||
2014 |
2013 | |||||
Cash and cash equivalents |
$ |
20,897 |
$ |
25,946 | ||
Restricted cash |
$ |
1,900 |
$ |
10,000 | ||
Total assets |
$ |
24,033 |
$ |
37,417 | ||
Total current liabilities, excluding current portion of notes payable |
$ |
5,186 |
$ |
4,784 | ||
Total notes payable |
$ |
8,386 |
$ |
17,875 | ||
Accumulated deficit |
$ |
(302,379) |
$ |
(287,207) | ||
Total shareholders' equity |
$ |
10,461 |
$ |
14,758 | ||
Common shares outstanding |
22,644,006 |
19,415,901 | ||||
SOURCE
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