Axcella Health Reports Third Quarter 2019 Financial Results and Provides Company Update
- Completed enrollment of an ongoing non-IND clinical study of AXA1125/AXA1957 in more than 100 adult subjects with NAFLD
- Announced intent to conduct future studies of AXA1125/AXA1957 under IND as therapeutic candidates for NASH
- On track to file an IND and initiate a registrational trial of AXA1665 for OHE in 2020
- Initiated a non-IND clinical study of hematology candidate AXA4010
-
Closed third quarter with
$105 million in cash and cash equivalents, providing runway through the second quarter of 2021
“We are excited by our team’s execution and are pleased to report back on the great strides we have made across our programs in recent months,” said
Recent Highlights
Liver Programs
- Presented data from non-IND clinical studies at The Liver Meeting™ on the multifactorial effects of AXA1665 observed in subjects with mild and moderate hepatic insufficiency and AXA1125 in subjects with Non-Alcoholic Fatty Liver Disease (NAFLD)
- Completed enrollment of a non-IND clinical study to assess the impact of AXA1125/AXA1957 on safety, tolerability and physiological impact in more than 100 adult subjects with NAFLD
- Initiated enrollment of a non-IND clinical study to assess the impact of AXA1957 on safety, tolerability and physiology in approximately 30 adolescent subjects with NAFLD
- Declared the company’s intent to conduct future studies of AXA1125/AXA1957 in patients with NASH under an IND
Blood Program
-
Announced an upcoming presentation of mechanistic data on the company’s hematology candidate AXA4010 at the 61st
American Society of Hematology (ASH) Annual Meeting and Exposition - Initiated a non-IND clinical study to assess the impact of AXA4010 on safety, tolerability and blood physiology in subjects with sickle cell disease
Muscle Program
- Announced a collaboration with CYTOO aimed at informing the development of new product candidates that promote skeletal muscle growth and function
Organization
-
Appointed
Catherine A. Sohn , Pharm.D. to replaceChristopher A. Viehbacher on the company’s Board of Directors
Anticipated 2020 Milestones
Liver Programs
- Early 2020: Complete enrollment in the company’s non-IND clinical study to assess the impact of AXA1665 on safety, tolerability and physiology in subjects with mild and moderate hepatic insufficiency
- First Half of 2020: Report data from the aforementioned non-IND clinical study of AXA1665
- Mid 2020: Report data from the company’s non-IND clinical study to assess the impact of AXA1125/AXA1957 on safety, tolerability and physiology in adult subjects with NAFLD
-
Second Half of 2020: Submit an IND application to the
U.S. Food and Drug Administration (FDA ) to study AXA1665 in patients with overt hepatic encephalopathy (OHE) - Second Half of 2020: Report data from the company’s non-IND clinical study to assess the impact of AXA1957 on safety, tolerability and physiology in adolescent subjects with NAFLD
Blood Program
- First Half of 2020: Complete enrollment in the company’s non-IND clinical study to assess the impact of AXA4010 on safety, tolerability and blood physiology in subjects with sickle cell disease
- Second Half of 2020: Report data from the aforementioned non-IND clinical study of AXA4010
Third Quarter Financial Results
For the third quarter ended
-
Research and development expenses were
$12.2 million . This compares with$6.1 million for the third quarter endedSeptember 30, 2018 . The increase in R&D expenses was primarily related to greater costs related to the company’s non-IND clinical studies and other expenses associated with the development of the company’s product candidates. -
General and administrative expenses were
$4.8 million . This compares with$2.1 million for the quarter endedSeptember 30, 2018 . The increase in G&A expenses was primarily related to higher professional services and employee-related costs associated with the company’s infrastructure growth. -
A net loss of approximately
$17.3 million , or$0.75 per basic and diluted share. This compares with a net loss of$8.8 million , or$1.85 per basic and diluted share, for the quarter endedSeptember 30, 2018 . -
Cash and cash equivalents at
September 30, 2019 were$105.4 million , which compares with$79.5 million atDecember 31, 2018 . The increase was the result of proceeds from the company’sMay 2019 initial public offering, partially offset by operating expenditures. Axcella continues to expect that its existing balance of cash and equivalents is sufficient to meet the company’s operating needs through the second quarter of 2021.
About Non-IND Clinical Studies
Axcella conducts non-investigational new drug application (Non-IND),
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. For more information, visit www.axcellahealth.com.
Internet Posting of Information
Axcella uses its website, www.axcellahealth.com, as a means of disclosing material nonpublic information and for complying with its disclosure obligations under Regulation FD. Such disclosures will be included in the “Investors and News” section of the company’s website. Accordingly, investors should monitor this portion of the website, in addition to following Axcella’s press releases,
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) |
|||||||||||
(in thousands, except share and per share data) |
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|
|
|
|
||||||||
|
Three Months Ended
|
|
Nine Months Ended
|
||||||||
|
2019 |
|
2018 |
|
2019 |
|
2018 |
||||
Operating expenses: |
|
|
|
|
|
|
|
||||
Research and development |
$ |
12,157 |
|
$ |
6,147 |
|
$ |
29,063 |
|
$ |
17,609 |
General and administrative |
4,840 |
|
2,087 |
|
13,036 |
|
7,124 |
||||
Total operating expenses |
16,997 |
|
8,234 |
|
42,099 |
|
24,733 |
||||
Loss from operations |
(16,997) |
|
(8,234) |
|
(42,099) |
|
(24,733) |
||||
Other income (expense): |
|
|
|
|
|
|
|
||||
Change in fair value of preferred stock warrant liability |
— |
|
5 |
|
(51) |
|
46 |
||||
Interest income (expense), net |
(307) |
|
(555) |
|
(1,174) |
|
(1,620) |
||||
Total other income (expense), net |
(307) |
|
(550) |
|
(1,225) |
|
(1,574) |
||||
Net loss |
$ |
(17,304) |
|
$ |
(8,784) |
|
$ |
(43,324) |
|
$ |
(26,307) |
Net loss per share, basic and diluted |
$ |
(0.75) |
|
$ |
(1.85) |
|
$ |
(3.01) |
|
$ |
(5.92) |
Weighted average common shares outstanding, basic and diluted |
23,083,367 |
|
4,769,387 |
|
14,430,397 |
|
4,470,013 |
Axcella Health Inc. |
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Condensed Consolidated Balance Sheet Data (Unaudited) |
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(in thousands) |
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|
|
|
|
|
|||||
|
|
September 30, 2019 |
|
December 31, 2018 |
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Assets: |
|
|
|
|
|||||
Cash and cash equivalents |
|
$ |
105,355 |
|
$ |
79,466 |
|||
Other assets |
|
3,832 |
|
|
2,378 |
|
|||
Total assets |
|
$ |
109,187 |
|
|
$ |
81,844 |
|
|
Liabilities and stockholders' (deficit) equity |
|
|
|
|
|||||
Liabilities |
|
$ |
34,843 |
|
$ |
33,755 |
|||
Preferred stock |
|
— |
|
|
197,842 |
|
|||
Stockholders' equity (deficit) equity |
|
74,344 |
|
|
(149,753) |
|
|||
Total liabilities and stockholders' equity |
|
$ |
109,187 |
|
|
$ |
81,844 |
|
View source version on businesswire.com: https://www.businesswire.com/news/home/20191112005946/en/
Source:
Company/Investor Contact
Jason Fredette
jfredette@axcellahealth.com
(857) 320-2236
Media Contact
Azeem Zeekrya
azeem.zeekrya@hdmz.com
(312) 506-5244