- Reported positive top-line data from AXA1125-003, with
clinically relevant reductions in liver fat content, insulin
resistance and fibroinflammation observed in subjects with NAFLD
receiving AXA1125
- Completed enrollment of AXA1665-002, with data readout expected
in Q3 2020
- Announced AXA2678 patent issuance and oral presentation at
ICSFR
- Launched new corporate website at www.axcellahealth.com
Axcella (Nasdaq: AXLA), a clinical-stage biotechnology company
focused on leveraging endogenous metabolic modulators (EMMs) to
pioneer a new approach for treating complex diseases and improving
health, today announced financial results for the first quarter
ended March 31, 2020 and provided a business update.
“These past few months have been a particularly exciting period
for Axcella, culminating in our recent report of positive top-line
data for AXA1125, our NASH product candidate, that we believe
further validates our platform,” said Bill Hinshaw, President and
Chief Executive Officer of Axcella. “In addition to these recent
data, we also completed enrollment in AXA1665-002 in the first
quarter and plan to provide a data readout from that ongoing
clinical study in the third quarter of 2020 despite the COVID-19
pandemic. With this and other milestones expected in the quarters
ahead, including expected regulatory engagements regarding our lead
product candidates, 2020 has the potential to be a transformational
year for Axcella.”
Recent Highlights
Liver Programs
- Reported positive top-line data from AXA1125-003, a clinical
study assessing the impact of AXA1125 and AXA1957 on safety,
tolerability and physiology in subjects with non-alcoholic fatty
liver disease (NAFLD). Results from the study showed that AXA1125
and AXA1957 were generally well-tolerated, with sustained
reductions noted for both product candidates versus placebo in key
biomarkers of metabolism, inflammation and fibrosis over 16 weeks.
Overall, as compared to both placebo and AXA1957, AXA1125
demonstrated larger and more consistent reductions in clinically
relevant biomarkers.
- Completed enrollment of AXA1665-002, an ongoing clinical study
assessing the impact of AXA1665 on safety, tolerability and
physiology in adult subjects with mild and moderate hepatic
insufficiency. AXA1665 has been generally safe and well tolerated
in this study to date. The company expects to report data from this
study in the third quarter of 2020.
Muscle Program
- Discussed Axcella’s AXA2678 muscle product candidate during an
oral presentation at the 2020 International Conference on Frailty
and Sarcopenia Research (ICFSR) in March 2020.
- Announced the issuance of U.S. Patent 10,596,136, which broadly
covers the use of AXA2678 and related EMM compositions for the
reduction of fat infiltration in muscle.
Corporate
- Launched a new corporate website at www.axcellahealth.com that
includes additional detail about the company’s platform, product
candidates and culture.
Anticipated 2020 Milestones
Liver Programs
- Q3 2020: Report data from AXA1665-002 in adult subjects with
mild and moderate hepatic insufficiency.
- Q4 2020: Submit an Investigational New Drug (IND) application
to the U.S. Food and Drug Administration (FDA) and initiate a
potential Phase 2b/3 registrational clinical trial of AXA1665 for
the reduction in risk of OHE recurrence.
- 2H 2020: Engage with the FDA to discuss the company’s planned
IND application for AXA1125, proposed Phase 2b clinical trial in
adults and pediatric development program.
Blood Program
- Q4 2020: Report top-line data from Cohort 1 of AXA4010-001, a
clinical study on safety, tolerability and blood physiology in
subjects with sickle cell disease.
Financial Results
R&D Expenses: Research and
development expenses were $10.3 million and $7.6 million for the
quarters ended March 31, 2020 and 2019, respectively. The change
was primarily related to greater costs associated with the
advancement of the company’s product candidates and ongoing
clinical studies.
G&A Expenses: General and
administrative expenses were $4.1 million and $3.5 million for the
quarters ended March 31, 2020 and 2019, respectively. The change
was primarily related to higher professional services and
employee-related costs associated with being a public company.
Net Loss: Net loss for the quarter
ended March 31, 2020 was $15.0 million, or $0.65 per basic and
diluted share. This compares with a net loss of $11.6 million, or
$2.43 per basic and diluted share, for the quarter ended March 31,
2019.
Cash Position: Cash and cash
equivalents at March 31, 2020 were $75.5 million, which compares
with $92.1 million at December 31, 2019. Axcella expects that its
cash and cash equivalents will be sufficient to meet the company’s
operating needs into the second quarter of 2021.
About Endogenous Metabolic Modulators (EMMs) EMMs are a
broad family of molecules, including amino acids, that regulate
human metabolism. Axcella is developing a range of novel product
candidates that are comprised of multiple EMMs engineered in
distinct combinations and ratios to simultaneously impact multiple
metabolic pathways to modify the root causes of various complex
diseases and improve health.
About Axcella’s Clinical Studies Each of the company’s
ongoing clinical studies are being conducted as non-investigational
new drug (IND) application clinical studies under U.S. Food and
Drug Administration regulations and guidance supporting research
with food. These studies evaluate product candidates for safety,
tolerability and effects on the normal structures and functions in
humans, including in individuals with disease. They are not
designed or intended to evaluate a product candidate’s ability to
diagnose, cure, mitigate, treat or prevent a disease. If Axcella
decides to further develop a product candidate as a potential
therapeutic, as is the case with AXA1665 and AXA1125, subsequent
studies will be conducted under an IND.
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 on the company’s
website in the “Investors and News” section. Accordingly, investors
should monitor such portions of the company’s website, in addition
to following its press releases, SEC filings and public conference
calls and webcasts.
About Axcella Axcella is a clinical-stage biotechnology
company focused on leveraging endogenous metabolic modulators
(EMMs) to pioneer a new approach for treating complex diseases and
improving health. The company’s product candidates are comprised of
EMMs and their derivatives that are engineered in distinct
combinations and ratios to simultaneously impact multiple
biological pathways. Axcella’s pipeline includes lead therapeutic
candidates for non-alcoholic steatohepatitis (NASH) and the
reduction in risk of overt hepatic encephalopathy (OHE) recurrence.
Additional muscle- and blood-related programs are in earlier-stage
development. For more information, please visit
www.axcellahealth.com.
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 characteristics,
competitive position and development potential of the company’s EMM
product candidates, including for AXA1125 and AXA1665, the design,
status and timing of the company’s ongoing clinical studies and
planned IND-enabled clinical trials, the company’s anticipated
program milestones, including the timing of AXA1665-002 and
AXA4010-001 data readouts, the subject and timing of the company’s
planned interactions with the FDA on the AXA1665 and AXA1125
programs including potential timing of IND application submissions,
and the potential of the company’s product candidates to impact
health and/or disease, including AXA1125’s potential in NASH and
AXA1665 potential in OHE. 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
potential impact of COVID-19 on the company’s ability to conduct
and complete its ongoing or planned clinical studies and IND
enabled clinical trials and planned interactions and submissions to
FDA or other regulatory authorities in a timely manner or at all
due to patient or principal investigator recruitment or
availability challenges, clinical trial site shutdowns or other
interruptions and potential limitations on the quality,
completeness and interpretability of data we are able to collect in
our ongoing AXA1665-002 and AXA4010-001 clinical studies and
potential delays in disclosure of the same, other potential impacts
of COVID-19 on our business and financial results, including with
respect to our ability to raise additional capital and operational
disruptions or delays, changes in law, regulations, or
interpretations and enforcement of regulatory guidance, whether
data readouts and/or FDA feedback support our IND submission and
clinical trial initiation plans and timing, clinical trial design
and target indication for AXA1125 and AXA1665, the clinical
development and safety profile of the company’s product candidates
and their health or therapeutic potential, whether and when, if at
all, the company’s product candidates will receive approval from
the FDA or other comparable regulatory authorities, and for which,
if any, indications, competition from other biotechnology
companies, past results from clinical studies not being
representative of future results, and other risks identified in the
company’s SEC filings, including Axcella’s Annual Report on Form
10-K, Quarterly Report on Form 10-Q and subsequent filings with the
SEC. The company cautions you not to place undue reliance on any
forward-looking statements, which speak only as of the date they
are made. Axcella disclaims any obligation to publicly update or
revise any such statements to reflect any change in expectations or
in events, conditions or circumstances on which any such statements
may be based, or that may affect the likelihood that actual results
will differ from those set forth in the forward-looking statements.
Any forward-looking statements contained in this press release
represent the company’s views only as of the date hereof and should
not be relied upon as representing its views as of any subsequent
date. The company explicitly disclaims any obligation to update any
forward-looking statements.
Axcella Health Inc.
Unaudited Condensed
Consolidated Balance Sheets
(in thousands)
March 31,
March 31,
2020
2019
Assets:
Cash and cash equivalents
$
75,522
$
66,769
Other assets
2,060
$
4,149
Total assets
$
77,582
$
70,918
Liabilities and stockholders' equity
(deficit):
Liabilities
$
30,768
$
33,253
Preferred stock
—
$
197,888
Stockholders' equity (deficit)
46,814
$
(160,223
)
Total liabilities and stockholders'
equity
$
77,582
$
70,918
Axcella Health Inc.
Unaudited Condensed
Consolidated Statements of Operations and Comprehensive
Loss
(in thousands, except share
and per share data)
Three Months Ended
March 31,
2020
2019
Operating expenses:
Research and development
$
10,335
$
7,563
General and administrative
4,125
3,468
Total operating expenses
14,460
11,031
Loss from operations
(14,460)
(11,031)
Other income (expense), net
(549)
(542)
Net loss and comprehensive loss
$
(15,009)
$
(11,573)
Net loss per share, basic and diluted
$
(0.65)
$
(2.43)
Weighted average common shares
outstanding, basic and diluted
23,188,816
4,775,828
View source
version on businesswire.com: https://www.businesswire.com/news/home/20200511005106/en/
Company/Investor Contact Jason Fredette
jfredette@axcellahealth.com (857) 320-2236
Media Contact Azeem Zeekrya azeem.zeekrya@hdmz.com (312)
506-5244
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