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Share Name | Share Symbol | Market | Type |
---|---|---|---|
Rocket Pharmaceuticals Inc | NASDAQ:RCKT | NASDAQ | Common Stock |
Price Change | % Change | Share Price | Bid Price | Offer Price | High Price | Low Price | Open Price | Shares Traded | Last Trade | |
---|---|---|---|---|---|---|---|---|---|---|
0.70 | 3.07% | 23.47 | 21.50 | 27.00 | 24.00 | 23.09 | 23.63 | 630,425 | 01:00:00 |
- Achieved Regulatory Designations for Fanconi Anemia (FA) in the U.S. and Europe; Registrational Trial on Track for 2019 -
- Presented Promising Fanconi Anemia Data at ASGCT -
- Adeno-associated Viral Vector Program Disclosure on Track for Fourth Quarter of 2018 -
Rocket Pharmaceuticals, Inc. (NASDAQ:RCKT) (“Rocket”), a leading U.S.-based multi-platform gene therapy company, today reported financial results for the quarter ended June 30, 2018, and provided an update on the Company’s recent achievements, as well as upcoming milestones.
“Rocket made significant progress on our clinical, regulatory and corporate initiatives in the second quarter,” said Gaurav Shah, M.D., Chief Executive Officer and President of Rocket. “We are pleased with the positive clinical data from our FA program that were presented at ASGCT and look forward to additional data over the next 12-18 months. The momentum has continued with recent regulatory designations for FA, including Rare Pediatric Disease from the U.S. Food and Drug Administration (FDA) and Advanced Therapy Medicinal Product (ATMP) by the European Medicines Agency (EMA). These positive steps set the stage nicely for a global registrational study in 2019.”
“Our additional gene therapy pipeline programs for devastating rare diseases remain on track. These include our products for Leukocyte Adhesion Deficiency-I (LAD-I), Pyruvate Kinase Deficiency (PKD) and our undisclosed adeno-associated viral vector (AAV) program. We expect to disclose the indication and share preclinical data from our AAV program later this year, and clinical data on up two programs in 2019. Our progress to date has been a true collaboration between the Rocket team, our partners, physicians, and the patients we serve. We look forward to meeting the milestones ahead.”
Recent Pipeline and Corporate Updates
Anticipated Milestones
September Conferences
Second Quarter 2018 Financial Results
Financial Guidance
About Rocket Pharmaceuticals, Inc.
Rocket Pharmaceuticals, Inc. (NASDAQ: RCKT) (“Rocket”) is an emerging, clinical-stage biotechnology company focused on developing first-in-class gene therapy treatment options for rare, devastating diseases. Rocket’s multi-platform development approach applies the well-established lentiviral vector (LVV) and adeno-associated viral vector (AAV) gene therapy platforms. Rocket's lead clinical program is a LVV-based gene therapy for the treatment of Fanconi Anemia (FA), a difficult to treat genetic disease that leads to bone marrow failure and potentially cancer. Preclinical studies of additional bone marrow-derived disorders are ongoing and target Pyruvate Kinase Deficiency (PKD), Leukocyte Adhesion Deficiency-I (LAD-I) and Infantile Malignant Osteopetrosis (IMO). Rocket is also developing an AAV-based gene therapy program for an undisclosed rare pediatric disease. For more information about Rocket, please visit www.rocketpharma.com.
Cautionary Statement Regarding Forward-Looking Statements
Various statements in this release concerning Rocket’s future expectations, plans and prospects, including without limitation, Rocket’s expectations regarding the safety, effectiveness and timing of product candidates that Rocket may develop, including in collaboration with academic partners, to treat Fanconi Anemia (FA), Leukocyte Adhesion Deficiency-I (LAD-I), Pyruvate Kinase Deficiency (PKD) and Infantile Malignant Osteopetrosis (IMO), and the safety, effectiveness and timing of related pre-clinical studies and clinical trials, may constitute forward-looking statements for the purposes of the safe harbor provisions under the Private Securities Litigation Reform Act of 1995 and other federal securities laws and are subject to substantial risks, uncertainties and assumptions. You should not place reliance on these forward-looking statements, which often include words such as "believe", "expect", "anticipate", "intend", "plan", "will give", "estimate", "seek", "will", "may", "suggest" or similar terms, variations of such terms or the negative of those terms. Although Rocket believes that the expectations reflected in the forward-looking statements are reasonable, Rocket cannot guarantee such outcomes. Actual results may differ materially from those indicated by these forward-looking statements as a result of various important factors, including, without limitation, Rocket’s ability to successfully demonstrate the efficacy and safety of such products and pre-clinical studies and clinical trials, its gene therapy programs, the preclinical and clinical results for its product candidates, which may not support further development and marketing approval, Rocket’s ability to commence a registrational study in FA within the projected time periods, the potential advantages of Rocket’s product candidates, actions of regulatory agencies, which may affect the initiation, timing and progress of pre-clinical studies and clinical trials of its product candidates, Rocket’s and its licensors ability to obtain, maintain and protect its and their respective intellectual property, the timing, cost or other aspects of a potential commercial launch of Rocket’s product candidates, Rocket’s ability to manage operating expenses, Rocket’s ability to obtain additional funding to support its business activities and establish and maintain strategic business alliances and new business initiatives, Rocket’s dependence on third parties for development, manufacture, marketing, sales and distribution of product candidates, the outcome of litigation, and unexpected expenditures, as well as those risks more fully discussed in the section entitled “Risk Factors” in Rocket’s Annual Report on Form 10-K for the year ended December 31, 2017. Accordingly, you should not place undue reliance on these forward-looking statements. All such statements speak only as of the date made, and Rocket undertakes no obligation to update or revise publicly any forward-looking statements, whether as a result of new information, future events or otherwise.
Selected Financial Information Operating Results: (amounts in thousands, except share and per share data) Three Months Ended June 30, Six Months Ended June 30, 2018 2017 2018 2017 Revenue $ - $ - $ - $ - Operating expenses: Research and development 10,772 $ 2,819 16,525 5,104 General and administrative 4,100 702 12,752 1,287 Total operating expenses 14,872 3,521 29,277 6,391 Loss from operations (14,872 ) (3,521 ) (29,277 ) (6,391 ) Research and development incentives - 192 186 192 Interest expense (1,363 ) - (2,834 ) - Interest income 473 - 805 - Other income (5 ) - 10 - Net loss $ (15,767 ) $ (3,329 ) $ (31,110 ) $ (6,199 ) Net loss per share attributable to common shareholders - basic and diluted $ (0.40 ) $ (0.49 ) $ (0.82 ) $ (0.91 ) Weighted-average common shares outstanding - basic and diluted 39,483,006 6,795,627 37,954,972 6,795,627 Selected Balance Sheet Information (amounts in thousands) June 30, December 31, 2018 2017 Cash, cash equivalents and investments 171,466 18,142 Total assets 207,574 20,147 Total liabilities 50,498 4,628 Total shareholders' equity 157,076 15,519
View source version on businesswire.com: https://www.businesswire.com/news/home/20180808005190/en/
Claudine Prowse, Ph.D.SVP Corporate Strategy and IRORocket Pharma, Inc.The Empire State Building, Suite 7530New York, NY 10118cp@rocketpharma.comwww.rocketpharma.cominvestors@rocketpharma.com
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