PR Newswire
SAN FRANCISCO, May 7, 2019
SAN FRANCISCO, May 7, 2019 /PRNewswire/ -- Audentes Therapeutics, Inc. (Nasdaq: BOLD), a leading AAV-based genetic medicines company focused on developing and commercializing innovative products for serious rare neuromuscular diseases, today reported its financial results for the first quarter ended March 31, 2019 and provided an update on the company's recent achievements and anticipated upcoming milestones.
"We are excited by the continued strong momentum across our business," stated Matthew R. Patterson, Chairman and Chief Executive Officer. "We recently presented new positive data from ASPIRO, the Phase 1/2 study of AT132 for the treatment of XLMTM, at the 22nd Annual Meeting of the American Society of Gene and Cell Therapy. These data further support the compelling profile of this important product candidate and help further our progress toward the goal of making AT132 globally available to patients living with XLMTM as rapidly as possible."
Mr. Patterson continued, "In our Pompe disease program, this quarter we successfully completed an initial NHP safety study of our product candidate AT845 and the encouraging results give us added confidence as we complete GLP toxicology and dose-ranging studies to support a third quarter IND submission. Finally, we are thrilled to have recently announced the expansion of our technology platform and development pipeline with the addition of programs utilizing vectorized antisense to address Duchenne muscular dystrophy and myotonic dystrophy, two devastating neuromuscular diseases."
Recent Achievements & Upcoming Key Events
AT132 for X-Linked Myotubular Myopathy (XLMTM):
AT845 for Pompe Disease:
AT702/AT751/AT753 for Duchenne Muscular Dystrophy (DMD):
AT466 for Myotonic Dystrophy (DM1):
AT342 for Crigler-Najjar Syndrome and AT307 for CASQ2-CPVT:
Manufacturing:
Corporate:
First Quarter 2019 Financial Results
Conference Call
At 4:30 p.m. Eastern Time today, Audentes management will host a conference call and a simultaneous webcast to discuss its first quarter 2019 financial results and provide a corporate update. To access a live webcast of the conference call, please visit the Events & Presentations page within the Investors + Media section of the Audentes website at www.audentestx.com. Alternatively, please call (833) 659-8620 (U.S.) or (409) 767-9247 (international) and dial the conference ID# 6839198 to access the call.
A replay of the webcast will be available on the Audentes website for approximately 30 days.
About Audentes Therapeutics, Inc.
Audentes Therapeutics (Nasdaq: BOLD) is a leading AAV-based genetic medicines company focused on developing and commercializing innovative products for serious rare neuromuscular diseases. We are leveraging our AAV gene therapy technology platform and proprietary manufacturing expertise to develop programs across three modalities: gene replacement, vectorized exon skipping, and vectorized RNA knockdown. Our product candidates are showing promising therapeutic profiles in clinical and preclinical studies across a range of neuromuscular diseases. Audentes is a focused, experienced and passionate team driven by the goal of improving the lives of patients.
For more information regarding Audentes, please visit www.audentestx.com.
Forward Looking Statements
This press release contains forward-looking statements within the meaning of the "safe harbor" provisions of the Private Securities Litigation Reform Act of 1995, including, but not limited to the expected benefits of the company's product candidates and technology platform, the timing and nature of the company's research, development and manufacturing activities, the nature of the results of the company's data, the timing for optimal dose selection and providing an update regarding license application submission plans for AT132, the timing of regulatory filings for AT132, AT845 and AT466, the expected market size of DMD and DM1 and the company's potential penetration into those markets and the company's intention to outlicense Crigler-Najjar and CASQ2-CPVT. All statements other than statements of historical fact are statements that could be deemed forward-looking statements. Although the company believes that the expectations reflected in such forward-looking statements are reasonable, the company cannot guarantee future events, results, actions, levels of activity, performance or achievements, and the timing and results of biotechnology development and potential regulatory approval is inherently uncertain. Forward-looking statements are subject to risks and uncertainties that may cause the company's actual activities or results to differ significantly from those expressed in any forward-looking statement, including risks and uncertainties related to the company's ability to advance its product candidates, obtain regulatory approval of and ultimately commercialize its product candidates, the timing and results of preclinical and clinical trials, the company's ability to fund development activities and achieve development goals, establish and scale-up manufacturing processes that comply with regulatory requirements, and protect intellectual property and other risks and uncertainties described under the heading "Risk Factors" in documents the company files from time to time with the Securities and Exchange Commission. These forward-looking statements speak only as of the date of this press release, and the company undertakes no obligation to revise or update any forward-looking statements to reflect events or circumstances after the date hereof.
Selected Financial Information
Operating Results | |||
Three months ended March 31, | |||
2019 | 2018 | ||
Unaudited | |||
Operating expenses: | |||
Research and development | $ 39,837 | $ 19,891 | |
General and administrative | 11,993 | 6,519 | |
Total operating expenses | 51,830 | 26,410 | |
Loss from operations | (51,830) | (26,410) | |
Interest income, net | 2,472 | 859 | |
Other expense, net | (33) | (20) | |
Net loss | $ (49,391) | $ (25,571) | |
Net loss per share, basic and diluted | $ (1.13) | $ (0.74) | |
Shares used in computing net loss per share, basic and diluted | 43,625,316 | 34,582,071 |
Selected Balance Sheet Data | ||||
March 31, 2019 | December 31, 2018 | |||
Unaudited | Audited | |||
Cash, cash equivalents, marketable securities | ||||
and restricted cash | $ 378,769 | $ 418,055 | ||
Total assets | $ 455,176 | $ 472,555 | ||
Total liabilities | $ 53,181 | $ 29,801 | ||
Total stockholders' equity | $ 401,995 | $ 442,754 |
Audentes Contacts:
Investor Contact:
Andrew Chang
415.818.1033
[email protected]
Media Contacts:
Sarah Spencer
415.957.2020
[email protected]
Katie Hogan
415.951.3398
[email protected]
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SOURCE Audentes Therapeutics, Inc.
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