- 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
- Phase 3 SOLUTION Clinical Study Enrollment open in EuropeIn 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 2016The 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/.
- 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 2016Following 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/.
- Phase 2 BRIGHT-SC Data Planned for Q2 2016We 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/.
- 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.
- 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 $0.28 per basic and diluted share in the same period in 2015.
|ANTHERA PHARMACEUTICALS, INC. CONSOLIDATED STATEMENTS OF OPERATIONS (in thousands, except share and per share data) (unaudited)|
|Three Months Ended March 31,|
|Research and development||$||9,624||$||5,995|
|General and administrative||2,238||1,907|
|Total operating expenses||11,862||7,902|
|Loss from operations||(11,717||)||(7,657||)|
|Other income (expense)||(9||)||(3||)|
|Total other income (expense)||(9||)||(3||)|
|Net loss per share attributable to common stockholders:|
|Basic and diluted||$||(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||$||46,951|
|Total deferred revenue||$||-||$||138|
|Total liabilities, excludes deferred revenue||$||8,036||$||8,330|
|Total shareholders' equity||$||30,820||$||39,657|
|Common shares outstanding||40,486,883||40,004,037|
CONTACT: Nikhil Agarwal of Anthera Pharmaceuticals, Inc.firstname.lastname@example.org or 510-856-5600x5621