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CARMIEL, Israel, Aug. 10, 2015 (GLOBE NEWSWIRE) -- Protalix BioTherapeutics, Inc. (NYSE MKT:PLX) (TASE:PLX), today reported financial results for the second quarter of 2015.
"We recently reported positive Phase I results for PRX-106 (oral Anti-TNF), with exciting results showing biological activity in the gut and activation of regulatory T cells," said Moshe Manor, Protalix's President and Chief Executive Officer. "We look forward to selecting an indication and moving this program into a proof of concept trial around year-end. Additionally, we anticipate interim results for PRX-102 for the treatment of Fabry disease in September, including 6-month data for the 1mg/kg dose group and 12-month data for the 0.2mg/kg group. We also expect to initiate a proof of concept study for AIR DNaseTM in Cystic Fibrosis patients early next year."
Financial Results for the Period Ended June 30, 2015
Second Quarter and Recent Clinical and Corporate Highlights
About Protalix BioTherapeutics, Inc.
Protalix is a biopharmaceutical company focused on the development and commercialization of recombinant therapeutic proteins expressed through its proprietary plant cell-based expression system, ProCellEx®. Protalix's unique expression system presents a proprietary method for developing recombinant proteins in a cost-effective, industrial-scale manner. Protalix's first product manufactured by ProCellEx, taliglucerase alfa, was approved for marketing by the U.S. Food and Drug Administration (FDA) in May 2012, by Israel's Ministry of Health in September 2012, by the Brazilian National Health Surveillance Agency (ANVISA) in March 2013, by the Mexican Federal Commission for the Protection against Sanitary Risk (COFEPRIS) in April 2013, by the Australian Therapeutic Goods Administration(TGA) in May 2014 and by the regulatory authorities of other countries. Marketing applications for taliglucerase alfa have been filed in additional territories as well. Protalix has partnered with Pfizer Inc. for the worldwide development and commercialization of taliglucerase alfa, excluding Israel and Brazil, where Protalix retains full rights. Protalix's development pipeline includes the following product candidates: PRX-102, a modified version of the recombinant human alpha-GAL-A protein for the treatment of Fabry disease; PRX-112, an orally-delivered glucocerebrosidase enzyme that is produced and encapsulated within carrot cells, also for the treatment of Gaucher disease; PRX-106, an orally-delivered anti-inflammatory treatment; PRX-110 for the treatment of Cystic Fibrosis; and others.
To the extent that statements in this press release are not strictly historical, all such statements are forward-looking, and are made pursuant to the safe-harbor provisions of the Private Securities Litigation Reform Act of 1995. The terms "anticipate," "believe," "estimate," "expect," "plan" and "intend" and other words or phrases of similar import are intended to identify forward-looking statements. These forward-looking statements are subject to known and unknown risks and uncertainties that may cause actual future experience and results to differ materially from the statements made. These statements are based on our current beliefs and expectations as to such future outcomes. Drug discovery and development involve a high degree of risk. Factors that might cause material differences include, among others: risks relating to the compliance by Fundação Oswaldo Cruz with its purchase obligations and related milestones under our supply and technology transfer agreement; risks related to the commercialization efforts for taliglucerase alfa in the United States, Israel, Brazil, Canada, Australia and other countries; failure or delay in the commencement or completion of our preclinical and clinical trials which may be caused by several factors, including: slower than expected rates of patient recruitment; unforeseen safety issues; determination of dosing issues; lack of effectiveness during clinical trials; inability to monitor patients adequately during or after treatment; inability or unwillingness of medical investigators and institutional review boards to follow our clinical protocols; and lack of sufficient funding to finance clinical trials; the risk that the results of the clinical trials of our product candidates will not support our claims of safety or efficacy, that our product candidates will not have the desired effects or will be associated with undesirable side effects or other unexpected characteristics; our dependence on performance by third party providers of services and supplies, including without limitation, clinical trial services; delays in our preparation and filing of applications for regulatory approval; delays in the approval or potential rejection of any applications we file with the FDA or other health regulatory authorities, and other risks relating to the review process; the inherent risks and uncertainties in developing drug platforms and products of the type we are developing; the impact of development of competing therapies and/or technologies by other companies and institutions; potential product liability risks, and risks of securing adequate levels of product liability and other necessary insurance coverage; and other factors described in our filings with the U.S. Securities and Exchange Commission. The statements in this release are valid only as of the date hereof and we disclaim any obligation to update this information.
|PROTALIX BIOTHERAPEUTICS, INC.|
|CONDENSED CONSOLIDATED BALANCE SHEETS|
|(U.S. dollars in thousands)|
|June 30, 2015||December 31, 2014|
|Cash and cash equivalents||$43,238||$54,767|
|Accounts receivable - Trade||1,936||1,884|
|Total current assets||53,868||65,520|
|FUNDS IN RESPECT OF EMPLOYEE RIGHTS UPON RETIREMENT||1,596||1,555|
|PROPERTY AND EQUIPMENT, NET||10,392||11,282|
|LIABILITIES NET OF CAPITAL DEFICIENCY|
|Accounts payable and accruals:|
|Total current liabilities||25,519||26,210|
|LONG TERM LIABILITIES:|
|Liability in connection with collaboration operation||912|
|Liability for employee rights upon retirement||2,288||2,253|
|Total long term liabilities||105,572||107,861|
|Total liabilities net of capital deficiency||$65,954||$78,470|
|PROTALIX BIOTHERAPEUTICS, INC.|
|CONDENSED CONSOLIDATED STATEMENTS OF OPERATIONS|
|(U.S. dollars in thousands, except share and per share data)|
|Six Months Ended||Three Months Ended|
|June 30, 2015||June 30, 2014||June 30, 2015||June 30, 2014|
|COMPANY'S SHARE IN COLLABORATION AGREEMENT||1,539||948||834||261|
|COST OF REVENUES||(4,439)||(5,678)||(2,039)||(1,605)|
|RESEARCH AND DEVELOPMENT EXPENSES (1)||(13,233)||(15,228)||(6,471)||(7,076)|
|Less – grants and reimbursements||2,649||4,199||1,514||2,114|
|RESEARCH AND DEVELOPMENT EXPENSES, NET||(10,584)||(11,029)||(4,957)||(4,962)|
|SELLING, GENERAL AND ADMINISTRATIVE EXPENSES (2)||(4,005)||(5,277)||(2,092)||(1,566)|
|FINANCIAL EXPENSES – NET||(1,728)||(1,549)||(599)||(672)|
|NET LOSS FOR THE PERIOD||$(11,043)||$(13,464)||$(5,071)||$(6,119)|
|NET LOSS PER SHARE OF COMMON STOCK - BASIC AND DILUTED:||$(0.12)||$(0.15)||$(0.05)||$(0.07)|
|WEIGHTED AVERAGE NUMBER OF SHARES OF COMMON STOCK USED IN COMPUTING LOSS PER SHARE – BASIC AND DILUTED:||93,418,666||92,754,640||93,635,213||92,820,897|
|(1) Includes share-based compensation||409||591||283||163|
|(2) Includes share-based compensation||564||(14)||271||(256)|
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