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Share Name | Share Symbol | Market | Type |
---|---|---|---|
Protalix BioTherapeutics Inc | AMEX:PLX | AMEX | Common Stock |
Price Change | % Change | Share Price | High Price | Low Price | Open Price | Shares Traded | Last Trade | |
---|---|---|---|---|---|---|---|---|
0.0004 | 0.04% | 1.0904 | 1.10 | 1.0795 | 1.08 | 74,901 | 01:00:00 |
- Losses narrowed by 19%
- Interim data and full results for PRX-102 expected in the Second Half of 2015
Protalix BioTherapeutics, Inc. (NYSE MKT:PLX) (TASE:PLX), today reported financial results for the quarter ended March 31, 2015.
"We continue to execute on our strategy for accelerated growth, which centers on developing products with clinically superior profiles and clear competitive advantages," said Moshe Manor, Protalix's President and Chief Executive Officer. "We have a number of key milestones anticipated to occur over the next few quarters that have the potential to create significant shareholder value. We plan to announce interim and full results from our phase I/II clinical trial of PRX-102 for the treatment of Fabry disease during the second half of 2015. Around year-end, we anticipate holding an end of Phase II meeting with the U.S. Food and Drug Administration for PRX-102, and initiating proof of concept clinical trials in patients for both oral antiTNF and AIR DNase. In the first half of 2016, we expect to launch a pivotal head-to-head phase III clinical trial of PRX-102 for the treatment of Fabry disease, and report results from our oral antiTNF and AIR DNase trials."
Financial Results for the Quarter Ended March 31, 2015
First Quarter and Recent Operational and Clinical 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.
Forward-Looking Statements
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 under our supply and technology transfer; 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: unforeseen safety issues; determination of dosing issues; lack of effectiveness during clinical trials; slower than expected rates of patient recruitment; 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) | |||||
(Unaudited) | |||||
March 31, 2015 | December 31, 2014 | ||||
ASSETS | |||||
CURRENT ASSETS: | |||||
Cash and cash equivalents | $ 47,958 | $ 54,767 | |||
Accounts receivable - Trade | 1,816 | 1,884 | |||
Other assets | 2,931 | 2,202 | |||
Inventories | 6,879 | 6,667 | |||
Total current assets | 59,584 | 65,520 | |||
FUNDS IN RESPECT OF EMPLOYEE RIGHTS UPON RETIREMENT | 1,520 | 1,555 | |||
PROPERTY AND EQUIPMENT, NET | 10,839 | 11,282 | |||
DEFERRED CHARGES | 105 | 113 | |||
Total assets | $ 72,048 | $ 78,470 | |||
LIABILITIES NET OF CAPITAL DEFICIENCY | |||||
CURRENT LIABILITIES: | |||||
Accounts payable and accruals: | |||||
Trade | $ 5,195 | $ 3,951 | |||
Other | 14,282 | 15,496 | |||
Deferred revenues | 7,072 | 6,763 | |||
Total current liabilities | 26,549 | 26,210 | |||
LONG TERM LIABILITIES: | |||||
Convertible notes | 67,566 | 67,464 | |||
Deferred revenues | 36,890 | 37,232 | |||
Liability in connection with collaboration operation | 912 | ||||
Liability for employee rights upon retirement | 2,197 | 2,253 | |||
Total long term liabilities | 106,653 | 107,861 | |||
Total liabilities | 133,202 | 134,071 | |||
COMMITMENTS | |||||
CAPITAL DEFICIENCY | (61,154) | (55,601) | |||
Total liabilities net of capital deficiency | $ 72,048 | $ 78,470 |
PROTALIX BIOTHERAPEUTICS, INC. | ||||
CONDENSED CONSOLIDATED STATEMENTS OF OPERATIONS | ||||
(U.S. dollars in thousands, except per share data) | ||||
(Unaudited) | ||||
Three Months Ended | ||||
March 31, 2015 | March 31, 2014 | |||
REVENUES | $ 4,392 | $ 6,696 | ||
COMPANY'S SHARE IN COLLABORATION AGREEMENT | 705 | 687 | ||
COST OF REVENUES | (2,400) | (4,073) | ||
GROSS PROFIT | 2,697 | 3,310 | ||
RESEARCH AND DEVELOPMENT EXPENSES (1) | (6,762) | (8,152) | ||
Less – grants and reimbursements | 1,135 | 2,085 | ||
RESEARCH AND DEVELOPMENT EXPENSES, NET | (5,627) | (6,067) | ||
SELLING, GENERAL AND ADMINISTRATIVE EXPENSES (2) | (1,913) | (3,711) | ||
OPERATING LOSS | (4,843) | (6,468) | ||
FINANCIAL EXPENSES | (1,157) | (915) | ||
FINANCIAL INCOME | 28 | 38 | ||
FINANCIAL EXPENSES – NET | (1,129) | (877) | ||
NET LOSS FOR THE PERIOD | $ (5,972) | $ (7,345) | ||
NET LOSS PER SHARE OF COMMON STOCK – BASIC AND DILUTED | $ 0.06 | $ 0.08 | ||
WEIGHTED AVERAGE NUMBER OF SHARES OF COMMON STOCK USED IN COMPUTING LOSS PER SHARE-BASIC AND DILUTED | 93,200,739 | 92,686,638 | ||
(1) Includes share-based compensation | 126 | 428 | ||
(2) Includes share-based compensation | 293 | 242 | ||
CONTACT: Investor Contact Marcy Nanus The Trout Group, LLC 646-378-2927 mnanus@troutgroup.com
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