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Share Name | Share Symbol | Market | Type |
---|---|---|---|
Boundless Bio Inc | NASDAQ:BOLD | NASDAQ | Common Stock |
Price Change | % Change | Share Price | Bid Price | Offer Price | High Price | Low Price | Open Price | Shares Traded | Last Trade | |
---|---|---|---|---|---|---|---|---|---|---|
0.11 | 2.75% | 4.11 | 4.07 | 4.15 | 4.11 | 3.90 | 4.00 | 42,964 | 19:00:32 |
- BLA submission for AT132 for the treatment of XLMTM on-track for mid-2020; MAA on-track for second half of 2020
- Continued progress in Pompe Disease, DMD and DM1 pipeline programs: AT845 IND submitted and clinical start-up activities underway; AT702 IND on track for first quarter 2020 submission
- Strong balance sheet with September 30, 2019 cash, cash equivalents and marketable securities of $351.5 million
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 third quarter ended September 30, 2019, and provided an update on the company’s recent achievements and anticipated upcoming milestones.
“2019 has been marked by significant progress across our portfolio, including the recent positive data update from our ASPIRO study at the 24th International Annual Congress of the World Muscle Society,” stated Matthew R. Patterson, Chairman and Chief Executive Officer. “AT132 continues to show a promising safety and efficacy profile in patients with XLMTM, with the first seven treated patients now ventilator independent, and we remain on track to submit the BLA for AT132 in mid-2020.”
Mr. Patterson continued, “Beyond AT132, we are excited about the significant momentum building across our entire pipeline of development candidates. Importantly, we met a major milestone with the submission of our IND for AT845 for the treatment of Pompe disease and remain on track to submit the first IND in our DMD program in the first quarter of next year. With these and other anticipated milestones in our DMD and DM1 programs, we look forward to 2020 as a year of important catalysts for the company and the advancement of our potentially best and first-in-class genetic medicines for devastating neuromuscular diseases.”
Recent Achievements & Upcoming Key Events:
AT132 for X-linked Myotubular Myopathy (XLMTM):
AT845 for Pompe Disease:
AT702/AT753/AT751 for Duchenne Muscular Dystrophy (DMD):
AT466 for Myotonic Dystrophy (DM1):
Manufacturing:
Third 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 third 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# 8575077 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, the timing and nature of regulatory filings for the company’s product candidates, the timing of the company’s presentation of non-clinical data and the timing and nature of the company’s preclinical studies, clinical trials and manufacturing activities. 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
Amounts in thousands except share and per share data
Operating Results
Three months ended September 30,
Nine months ended September 30,
2019
2018
2019
2018
Unaudited Operating expenses: Research and development
$
37,636
$
29,918
$
114,772
$
76,157
General and administrative
10,189
7,817
31,960
20,617
Total operating expenses
47,825
37,735
146,732
96,774
Loss from operations
(47,825
)
(37,735
)
(146,732
)
(96,774
)
Interest income, net
2,112
1,509
6,937
3,662
Other expense, net
(28
)
(65
)
(101
)
(117
)
Net loss$
(45,741
)
$
(36,291
)
$
(139,896
)
$
(93,229
)
Net loss per share, basic and diluted$
(1.00
)
$
(0.97
)
$
(3.14
)
$
(2.57
)
Shares used in computing net loss per share, basic and diluted
45,543,354
37,359,877
44,538,676
36,302,803
Selected Balance Sheet Data
September 30, 2019 December 31, 2018 Unaudited Cash, cash equivalents, marketable securities and restricted cash$
355,212
$
418,055
Total assets$
441,508
$
472,555
Total liabilities$
58,049
$
29,801
Total stockholders' equity$
383,459
$
442,754
View source version on businesswire.com: https://www.businesswire.com/news/home/20191107005986/en/
Audentes Contacts:
Investor Contact: Andrew Chang 415.818.1033 achang@audentestx.com
Media Contact: Sarah Spencer 415.957.2020 sspencer@audentestx.com
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