- SOLUTION clinical study of Sollpura™ expanded to Europe, Israel and Canada in addition to ongoing US enrollment
- Craig Thompson named as President and Chief Operating Officer
- Appointment of Dr. James Pennington to Interim Chief Medical Officer
- Enrollment of BRIGHT-SC Phase 2 clinical study in IgA Nephropathy completed
- Bulk manufacturing campaign for blisibimod completed for CHABLIS-7.5
HAYWARD, Calif., May 09, 2016 (GLOBE NEWSWIRE) -- Anthera Pharmaceuticals, Inc. (Nasdaq:ANTH) today provided a business update and reported financial results for the first quarter ended March 31, 2016.
Recent Developments and Business Highlights:
Sollpura™ (liprotamase) – Exocrine Pancreatic Insufficiency
- Phase 3 SOLUTION Clinical Study Enrollment open in Europe
In the first quarter of 2016, we continued further clinical site activation for the Phase 3 SOLUTION clinical study to include four European countries, Israel and Canada. This study evaluates the efficacy and safety of the capsule formulation of Sollpura™ to treat exocrine pancreatic insufficiency in patients with cystic fibrosis. - SIMPLICITY Clinical Study expected to begin enrollment in Q2 2016
The SIMPLICITY clinical study will be the first to offer Sollpura™ supplied in a convenient, easy-to-administer packet, which can be mixed with water or apple juice for drinkable dose administration. After an initial cohort of patients older than 7, this study will allow for administration of Sollpura™ powder for oral solution to pediatric patients ranging in age from 28 days to seven years. For more information on the study, visit http://www.anthera.com/clinical-studies/simplicity-study/.
Blisibimod - Systemic Lupus Erythematosus (“SLE”)
- Topline Data from Phase 3 CHABLIS-SC1 Clinical Study
We continue to collect and finalize data from the CHABLIS-SC1 study, which will be released later this year.
- Phase 3 CHABLIS 7.5 Clinical Study to Initiate in Q2 2016
Following the completion of a bulk drug manufacturing campaign and clinical site activations, the CHABLIS 7.5 study is expected to begin enrollment in Q2 2016. This study will evaluate the efficacy and safety of blisibimod in patients who, despite corticosteroid use, continue to have clinically-active Lupus (SLE) and the presence of anti-double-stranded DNA and low complement which are of known serological markers of lupus. For more information about the CHABLIS 7.5 study, visit http://www.anthera.com/clinical-studies/chablis_7-5/.
Blisibimod – IgA Nephropathy
- Phase 2 BRIGHT-SC Data Planned for Q2 2016
We plan to conduct a proof-of-concept efficacy analysis of the BRIGHT-SC study when all patients have received a minimum of six months of therapy in Q2. This analysis will examine the effects of blisibimod versus placebo in the proportion of qualifying patients who achieve a complete response or a partial response at six months. As well, the effects of blisibimod on various disease markers will be assessed. For more information about the BRIGHT-SC study, visit http://www.anthera.com/clinical-studies/bright-sc/.
Management Update
- On January 7, 2016, we expanded our executive management team with the appointment of Craig Thompson as our President and Chief Operating Officer. In this role, Mr. Thompson will oversee both our late stage development programs and launch readiness efforts. Mr. Thompson joins Anthera with over 20 years of experience in pharmaceutical development and commercialization. Most recently he served as the Chief Operating Officer for Tetraphase Pharmaceuticals where he oversaw the development and implementation of the commercial strategy as well as the business development and commercial manufacturing. Prior to Tetraphase Pharmaceuticals, Mr. Thompson served as the Chief Commercial Officer for Trius Therapeutics resulting in the acquisition of Trius by Cubist Pharmaceuticals for over $700 million.
- On March 7, 2016, our Board appointed Dr. James Pennington as our Interim Chief Medical Officer, effective April 1, 2016. Dr. Pennington joined Anthera in 2007 and has over 40 years of successful clinical development and commercialization experience including 14 drug approvals and 10 registration ex-US approvals including both small and large molecule therapeutics. Our search for a permanent Chief Medical Officer is progressing well.
Summary of Financial Results
- Cash Position. Cash and cash equivalents totaled $38 million as of March 31, 2016, compared to $47 million as of December 31, 2015. The decrease in cash was mainly attributable to research, development and operational expenses during the first quarter of 2016 and in line with our expectations.
- Revenues. License and collaborative revenues for the quarter ended March 31, 2016 totaled $145,000.
- R&D Expense. Research and development expenses for the quarter ended March 31, 2016 totaled $9.6 million, compared to $6.0 million in the same period in 2015. The increase is due to higher clinical development expenses of $3.4 million to support our ongoing clinical programs and preparation for two new Phase 3 studies, namely the SIMPLICITY study with Sollpura and the CHABLIS-7.5 study with blisibimod in severe lupus patients, and higher non-cash stock-based compensation expense of $0.2 million recognized during the first quarter of 2016 as a result of a greater number of outstanding and unvested stock options.
- G&A Expense. General and administrative expenses for the quarter ended March 31, 2016 totaled $2.2 million, compared to $1.9 million in the same period in 2015. The increase is due to higher non-cash compensation expense of $0.4 million recognized during the first quarter of 2015 as a result of a greater number of outstanding and unvested stock options.
- Net Loss. Net loss for the quarter ended March 31, 2016 was $11.7 million, or $0.29 per basic and diluted share, compared to $7.7 million, or $0.28 per basic and diluted share in the same period in 2015.
About Anthera Pharmaceuticals
Anthera Pharmaceuticals is a clinical-stage biopharmaceutical company focused on developing and commercializing products to treat serious and life-threatening diseases, including exocrine pancreatic insufficiency due to cystic fibrosis, lupus, lupus with glomerulonephritis, and IgA nephropathy. Additional information on the Company can be found at www.anthera.com.
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 Annual Report on Form 10-k for the year ended December 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.
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| ANTHERA PHARMACEUTICALS, INC. CONSOLIDATED STATEMENTS OF OPERATIONS (in thousands, except share and per share data) (unaudited) | ||||||||||||||||
| Three Months Ended March 31, | ||||||||||||||||
| 2016 | 2015 | |||||||||||||||
| Revenues: | ||||||||||||||||
| License revenue | $ | 139 | $ | 49 | ||||||||||||
| Collaboration revenue | 6 | 196 | ||||||||||||||
| Total revenues | 145 | 245 | ||||||||||||||
| Operating Expenses: | ||||||||||||||||
| Research and development | $ | 9,624 | $ | 5,995 | ||||||||||||
| General and administrative | 2,238 | 1,907 | ||||||||||||||
| Total operating expenses | 11,862 | 7,902 | ||||||||||||||
| Loss from operations | (11,717 | ) | (7,657 | ) | ||||||||||||
| Other Expenses: | ||||||||||||||||
| Other income (expense) | (9 | ) | (3 | ) | ||||||||||||
| Total other income (expense) | (9 | ) | (3 | ) | ||||||||||||
| Net loss | $ | (11,726 | ) | $ | (7,660 | ) | ||||||||||
| Net loss per share attributable to common stockholders: | ||||||||||||||||
| Basic and diluted | $ | (0.29 | ) | $ | (0.28 | ) | ||||||||||
| Weighted-average number of shares used in per share calculation: basic and diluted | 40,049,895 | 27,595,081 | ||||||||||||||
| ANTHERA PHARMACEUTICALS, INC. BALANCE SHEET DATA (in thousands, except share data) (unaudited) | ||||||||||||||||
| March 31, 2016 | December 31, 2015 | |||||||||||||||
| Cash and cash equivalents | $ | 37,877 | $ | 46,951 | ||||||||||||
| Accounts receivable | $ | - | $ | 326 | ||||||||||||
| Total assets | $ | 38,856 | $ | 48,125 | ||||||||||||
| Total deferred revenue | $ | - | $ | 138 | ||||||||||||
| Total liabilities, excludes deferred revenue | $ | 8,036 | $ | 8,330 | ||||||||||||
| Accumulated deficit | $ | (363,757 | ) | $ | (352,031 | ) | ||||||||||
| Total shareholders' equity | $ | 30,820 | $ | 39,657 | ||||||||||||
| Common shares outstanding | 40,486,883 | 40,004,037 | ||||||||||||||