Net loss for the quarter and six months ended
Research and development expenses for the quarter and six months ended
General and administrative expense for the quarter and six months ended
Non-operating expense for the quarter and six months ended
As of June 30, 2015, we had cash and cash equivalents of $35.5 million, compared to $2.6 million as of December 31, 2014. On
Second Quarter Operational Update:
Preparation is underway to initiate our Phase 3 clinical study, SOLUTION, in patients with cystic fibrosis who suffer from exocrine pancreatic insufficiency in the U.S. and
Planning has begun for a second clinical study in infants and toddlers aged 28 days to 7 years. SIMPLICITY will use a powder formulation of Sollpura™ in sachet for ease of administration. The SIMPLICITY clinical study is currently planned for initiation in late 2015 or early 2016. Manufacturing activities to support the SOLUTION and SIMPLICITY studies, including the manufacture of two dosage strengths of Sollpura™ capsules and sachet formulation are in progress.
Blisibimod - Systemic Lupus Erythematosus ("SLE")
During the second quarter of 2015, we surpassed the enrollment target of 400 patients for the Phase 3 CHABLIS-SC1 clinical study.
With the additional funding from our July public offering, we began planning for our second lupus study, CHABLIS 7.5 (formerly named CHABLIS-SC2), whose name emphasizes the intent to reduce background corticosteroid medication to ≤7.5mg prednisone. The CHABLIS 7.5 study will evaluate the effect of blisibimod on top of standard-of-care medication in patients with severe, seropositive SLE that is inadequately controlled with corticosteroids. Patient eligibility for this study is informed by responder traits identified in the Phase 2 study with blisibimod as well as the large Phase 3 programs with other BAFF inhibitors, belimumab and tabalumab. For more information about the CHABLIS 7.5 study, please visit https://clinicaltrials.gov/ct2/show/NCT02514967.
Blisibimod - IgA Nephropathy
Expansion of our Phase 2/3 BRIGHT-SC clinical study in patients with IgA nephropathy is ongoing. We currently expect over 50 investigative sites will be actively recruiting patients by the end of 2015.
About Anthera Pharmaceuticals
Anthera Pharmaceuticals is a biopharmaceutical company focused on advancing the development and commercialization of innovative medicines that benefit patients with unmet medical needs.
Safe Harbor Statement
Any statements contained in this press release that refer to future events or other non-historical matters, including statements that are preceded by, followed by, or that include such words as "estimate," "intend," "anticipate," "believe," "plan," "goal," "expect," "project," or similar statements, are forward-looking statements made pursuant to the safe harbor provisions of the Private Securities Litigation Reform Act of 1995. These forward-looking statements include statements about Anthera's expectations with respect to its public offering, including statements about its intended use of proceeds from the offering. Such 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, including but not limited to those set forth in Anthera's public filings with the SEC, including Anthera's Quarterly Report on Form 10-Q for the quarter ended March 31, 2015. Anthera disclaims any intent or obligation to update any forward-looking statements, whether because of new information, future events or otherwise, except as required by applicable law.
CONSOLIDATED STATEMENTS OF OPERATIONS
(in thousands, except share and per share data)
Three Months Ended
Six Months Ended
|License fee||$ 146||$ —||$ 195||$ —|
|Research and development||$ 8,539||$ 5,279||$ 14,534||$ 11,044|
|General and administrative||1,696||1,586||3,603||3,430|
|Total operating expenses||9,135||6,865||17,037||14,474|
|Loss from operations||(8,846)||(6,865)||(16,503)||(14,474)|
|Total other expenses||(49)||(391)||(52)||(698)|
|Net loss||$ (8,895)||$ (7,256)||$ (16,555)||$ (15,172)|
|Net loss per share attributable to common stockholders:|
|Basic and diluted||$ (0.25)||$ (0.34)||$ (0.52)||$ (0.73)|
|Weighted-average number of shares used in per share calculation: basic and diluted||35,817,794||21,479,386||31,729,152||20,805,162|
BALANCE SHEET DATA
(in thousands, except share data)
|Cash and cash equivalents||
|Total deferred revenue||
|Total liabilities, excludes deferred revenue||$ 8,252||$ 5,751|
|Total shareholders' equity (deficit)||
|Common shares outstanding||35,870,664||23,005,209|
Nikhil Agarwalof Anthera Pharmaceuticals, Inc.firstname.lastname@example.org or 510-856-5621x5621
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