Axcella Health Reports Second Quarter 2019 Financial Results and Provides Company Update
Initiated a Non-IND, IRB-Approved Clinical Study for AXA1957 in adolescent subjects with NAFLD
Announced the publication in Frontiers of data describing attenuation of muscle atrophy observed with AXA2678 in short-term muscle disuse study
Finished the second quarter with
“Our Company continued to make headway in the clinic with the initiation of our first study in adolescents. This Non-IND, IRB-Approved Clinical Study is being conducted in subjects with Non-Alcoholic Fatty Liver Disease or NAFLD. NAFLD is driven by metabolic dysregulation which is increasing in incidence. We believe our unique development model and ability to generate human data prior making a development path decision for our AXA Candidates provides the potential to make rapid and well-informed product development decisions. Our ongoing clinical programs, including AXA1665 for Hepatic Encephalopathy and AXA1125/AXA1957 in liver are progressing well and we look forward to completing enrollment and anticipate reporting additional human data next year,” said
Corporate Highlights
-
In
July 2019 , Axcella initiated a Non-IND, IRB-Approved Clinical Study for AXA1957 in adolescent subjects with NAFLD -
In
July 2019 , Axcella announced the publication of data describing attenuation of muscle atrophy observed with AXA2678 in short-term muscle disuse study -
In
May 2019 , Axcella completed its initial public offering, raising gross proceeds of$71.4 million through the sale of 3,571,428 shares of common stock at an initial public offering price of$20.00 per share and commenced trading on TheNasdaq Global Market under the ticker symbol AXLA
Anticipated Milestones
- Initiate a Non-IND, IRB-Approved Clinical Study of AXA4010 in subjects with sickle cell disease in the second half of 2019
- Report data from our Non-IND, IRB-Approved Clinical Study of AXA1665 in subjects with hepatic insufficiency in the first half of 2020
- Report data from our Non-IND, IRB-Approved Clinical Study of AXA1125 and AXA1957 in adult subjects with NAFLD in the second half of 2020
- Report data from our Non-IND, IRB-Approved Clinical Study of AXA1957 in adolescent subjects with NAFLD in the second half of 2020
- Report data from our Non-IND, IRB-Approved Clinical Study of AXA4010 in subjects with sickle cell disease in the second half of 2020
Second Quarter Financial Results
For the second quarter ended
Research and development expenses for the quarter ended
General and administrative expenses were
Cash and cash equivalents were
Six Month Financial Results
Net loss for the first six months of 2019 was
Cash Flows used in operating activities for the six months ended
About
Axcella is designing and developing AXA Candidates, compositions of endogenous metabolic modulators, or EMMs, engineered in distinct ratios, designed to target and maximize the fundamental role that EMMs play in regulating multiple metabolic functions. Axcella’s AXA Candidates are generated from its proprietary, human-focused AXA Development Platform. Axcella believes its expertise and capabilities in EMMs position it to become a preeminent biotechnology company reprogramming metabolism to address a diverse set of complex diseases and support health. Axcella’s AXA Development Platform has already produced a pipeline of product candidates in programs targeting liver, muscle and blood. Axcella was founded by Flagship Pioneering.
About Non-IND, IRB-Approved Clinical Studies
Axcella conducts non-investigational new drug application (Non-IND),
Forward-Looking Statements
This press release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995, as amended, including, without limitation, statements regarding the development potential and development pathway of our current AXA Candidates, potential expansion into new therapeutic fields, the timing of our clinical studies and the timing of receipt of data from the same, our liquidity, including our expected cash runway, and our strategy, business plans and focus. The words “may,” “will,” “could,” “would,” “should,” “expect,” “plan,” “anticipate,” “intend,” “believe,” “estimate,” “predict,” “project,” “potential,” “continue,” “target” and similar expressions are intended to identify forward-looking statements, although not all forward-looking statements contain these identifying words. Any forward-looking statements in this press release are based on management’s current expectations and beliefs and are subject to a number of risks, uncertainties and important factors that may cause actual events or results to differ materially from those expressed or implied by any forward-looking statements contained in this press release, including, without limitation, those related to the breadth of our pipeline of product candidates, the strength of our proprietary product platform, the efficiency of our discovery and development approach, the clinical development and safety profile of our AXA Candidates and their health or therapeutic potential, whether and when, if at all, our AXA Candidates will become commercial products or, if applicable, receive approval from the
Axcella Health Inc. |
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Condensed Consolidated Statements of Operations (Unaudited) |
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(in thousands, except share and per share data) |
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|
|
|
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Three Months Ended
|
|
Six Months Ended
|
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|
2019 |
|
2018 |
|
2019 |
|
2018 |
||||||||
Operating expenses: |
|
|
|
|
|
|
|
||||||||
Research and development |
$ |
9,343 |
|
|
$ |
6,007 |
|
|
$ |
16,906 |
|
|
$ |
11,462 |
|
General and administrative |
4,728 |
|
|
2,901 |
|
|
8,196 |
|
|
5,037 |
|
||||
Total operating expenses |
14,071 |
|
|
8,908 |
|
|
25,102 |
|
|
16,499 |
|
||||
Loss from operations |
(14,071 |
) |
|
(8,908 |
) |
|
(25,102 |
) |
|
(16,499 |
) |
||||
Other income (expense): |
|
|
|
|
|
|
|
||||||||
Change in fair value of preferred stock warrant liability |
— |
|
|
4 |
|
|
(51 |
) |
|
41 |
|
||||
Interest income (expense), net |
(376 |
) |
|
(519 |
) |
|
(867 |
) |
|
(1,065 |
) |
||||
Total other income (expense), net |
(376 |
) |
|
(515 |
) |
|
(918 |
) |
|
(1,024 |
) |
||||
Net loss |
$ |
(14,447 |
) |
|
$ |
(9,423 |
) |
|
$ |
(26,020 |
) |
|
$ |
(17,523 |
) |
Net loss per share, basic and diluted |
$ |
(0.95 |
) |
|
$ |
(2.15 |
) |
|
$ |
(2.60 |
) |
|
$ |
(4.08 |
) |
Weighted average common shares outstanding, basic and diluted |
15,230,815 |
|
|
4,405,597 |
|
|
10,032,202 |
|
|
4,317,845 |
|
Axcella Health Inc. |
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Condensed Consolidated Balance Sheet Data (Unaudited) |
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(in thousands) |
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|
|
|
|
|
|||||
|
|
June 30, |
|
December 31, |
|||||
|
|
2019 |
|
2018 |
|||||
Assets: |
|
|
|
|
|||||
Cash and cash equivalents |
|
$ |
117,910 |
|
|
|
$ |
79,466 |
|
Other assets |
|
4,497 |
|
|
2,378 |
|
|||
Total assets |
|
$ |
122,407 |
|
|
$ |
81,844 |
|
|
Liabilities and stockholders' (deficit) equity |
|
|
|
|
|||||
Liabilities |
|
$ |
32,463 |
|
|
|
$ |
33,755 |
|
Preferred stock |
|
— |
|
|
|
197,842 |
|
||
Stockholders' equity (deficit) equity |
|
89,944 |
|
|
|
(149,753 |
) |
||
Total liabilities and stockholders' equity |
|
$ |
122,407 |
|
|
|
$ |
81,844 |
|
View source version on businesswire.com: https://www.businesswire.com/news/home/20190812005606/en/
Source:
Investor Contact
Lauren Stival
ir@axcellahealth.com
(212) 698-8646
Company Contact
Alison Williams
awilliams@axcellahealth.com
(857) 320-2204