- Announced positive interim findings from ongoing clinical study
of AXA1125 and AXA1957; expect to report top-line data in second
quarter of 2020
- Completed enrollment in ongoing clinical study of AXA1665;
expect to report top-line data in third quarter of 2020
- Bolstered intellectual property portfolio with new patent
issuance for AXA1125 and AXA1957
- Strengthened management team
- Company provides COVID-19 update
Axcella Health Inc. (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 fourth quarter and full year ended December 31, 2019 and
provided a business update.
“Axcella made great strides in 2019 as we presented data at
preeminent medical congresses, bolstered our intellectual property
portfolio, completed our IPO and strengthened our management team
and Board of Directors. We also initiated four clinical studies
during the year to provide us with significant human data to inform
our clinical development plans and regulatory engagements,” said
Bill Hinshaw, President and Chief Executive Officer of Axcella. “As
we entered 2020, this strong momentum continued as we completed
enrollment of our clinical study of AXA1665 and announced positive
interim findings from our clinical study of AXA1125 and AXA1957. We
look forward to multiple planned readouts during the remainder of
the year and remain on track to report top-line data for our lead
candidates for nonalcoholic steatohepatitis (NASH) and overt
hepatic encephalopathy (OHE) in mid-2020.
“Meanwhile, the impacts of the COVID-19 outbreak on our society
and in the medical community are far-reaching and rapidly
evolving,” continued Mr. Hinshaw. “As it relates to Axcella, we
have taken a series of actions aimed at safeguarding our staff and
business associates, including implementing a work-at-home policy,
providing flexibility for working parents and suspending all
business-related travel. We also are keeping in close virtual
contact with our service providers and clinical sites in order to
assess and minimize impact to our programs.”
Recent Highlights
Liver Programs
- Announced interim findings from AXA1125-003, the company’s
ongoing clinical study assessing the impact of AXA1125 and AXA1957
on safety, tolerability and physiology in more than 100 adult
subjects with non-alcoholic fatty liver disease (NAFLD). The
analysis showed that AXA1125 and both doses of AXA1957 had been
well tolerated to date. Additionally, both AXA1125 and AXA1957
demonstrated clinically relevant responses on the three biological
nodes fundamental to liver health and disease: metabolism,
inflammation and fibrogenesis. The onset of response in some
biomarkers was seen as early as the eight-week, post-baseline
assessment with continued improvement through 16 weeks. These
findings were highlighted at the 2020 NASH-TAG Conference in
January 2020.
- Completed enrollment of AXA1665-002, an ongoing clinical study
to assess 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.
- Announced the issuance of U.S. Patent 10,471,034, which covers
an array of EMM compositions, including AXA1125 and AXA1957, the
company’s product candidates for NASH.
Blood Program
- Presented mechanistic data on the company’s hematology product
candidate AXA4010 at the 61st American Society of Hematology (ASH)
Annual Meeting and Exposition.
Muscle Program
- Discussed Axcella’s AXA2678 muscle product candidate during an
oral presentation at the 2020 International Conference on Frailty
and Sarcopenia Research (ICFSR).
Organization
- Appointed Laurent Chardonnet as the company’s Chief Financial
Officer and promoted Heidy King-Jones to General Counsel.
Anticipated 2020 Milestones
Liver Programs
- Q2 2020: Report top-line data from AXA1125-003 in adult
subjects with NAFLD. Since enrollment in this clinical study was
completed in October 2019, Axcella does not currently anticipate
the COVID-19 outbreak to impact the timing of its readout.
- Q3 2020: Report top-line data from AXA1665-002 in adult
subjects with mild and moderate hepatic insufficiency. Since
enrollment in this clinical study was completed in February 2020,
Axcella does not currently anticipate the COVID-19 outbreak to
impact the timing of its readout.
- 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.
- AXA1957 Update: As a result of a resource reallocation from
studies and trials toward COVID-19 detection and treatment at
clinical sites involved in AXA1957-002, enrollment and dosing in
this pediatric clinical study has been temporarily suspended.
Axcella continues to view pediatric NASH as a significant area of
unmet need. Utilizing information gathered thus far from
AXA1957-002 and the upcoming top-line readout from AXA1125-003, the
company plans to provide an update on its plans for this program at
a future date.
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 $10.8 million and $7.9 million for the
quarters ended December 31, 2019 and 2018, respectively. Research
and development expenses were $41.7 million and $25.5 million for
the years ended December 31, 2019 and 2018, respectively. The
increase in both periods 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 $4.6 million and $1.3 million for the
quarters ended December 31, 2019 and 2018, respectively. General
and administrative expenses were $15.8 million and $8.4 million for
the years ended December 31, 2019 and 2018, respectively. The
increase in both periods 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 December 31, 2019 was $15.7 million, or $0.68 per basic and
diluted share. This compares with a net loss of $9.8 million, or
$2.05 per basic and diluted share, for the quarter ended December
31, 2018. Net loss for the year ended December 31, 2019 was $59.0
million, or $3.55 per basic and diluted share. This compares with a
net loss of $36.1 million, or $7.97 per basic and diluted share,
for the year ended December 31, 2018.
Cash Position: Cash and cash
equivalents at December 31, 2019 were $92.1 million, which compares
with $79.5 million at December 31, 2018. The increase was the
result of proceeds from the company’s May 2019 initial public
offering, partially offset by operating expenditures. 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 AXA1125/1957,
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 and
development potential of the company’s EMM product candidates, the
design, status and timing of the company’s ongoing clinical studies
and planned IND-enabled clinical trials and the results, including
the quality, completeness, and interpretability of results, and the
timing of receipt and disclosure of data results from the same,
including with respect to the company’s ongoing clinical studies
for AXA1125, AXA1957 and AXA1665 and planned clinical trial for
AXA1665, the subject and timing of the company’s interactions with
the FDA, including with respect to the potential filing of an IND
for AXA1665, the sufficiency of the company’s cash and cash
equivalents to meet operating needs, the potential of the Company’s
product candidates to impact health and/or disease, including
AXA1125 and AXA1957’s potential in NASH and AXA1665 potential in
OHE, and the effect of the COVID-19 outbreak on any of the
foregoing. 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
clinical study recruitment, including on clinical site, staff and
subject availability, potential clinical study delays and holds,
regulatory limitations and operations and the completeness and
quality of data we are able to collect from ongoing clinical
studies, and the company’s ability to conduct and complete its
ongoing clinical studies and planned clinical trials in a time
manner or at all, 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, the breadth and potential uses of the company’s pipeline of
product candidates, including the potential for AXA1665 to benefit
OHE patients, whether planned data readouts and disclosures are
positive and support our beliefs regarding EMMs and AXA1125/AXA1957
and AXA1665’s potential ability to benefit not just healthy but
also diseased patients, including patients with NASH and OHE,
respectively, and the planned timing of our disclosures regarding
data readouts, whether data readouts and/or FDA feedback support
our planned timing for an IND filing, clinical trial design and
target indication for AXA1125/ AXA1957 and AXA1665, the potential
for the planned AXA1665 IND clinical trial to be registrational,
the strength of the company’s development platform, the efficiency
of the company’s discovery and development approach, 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 U.S. Food and Drug Administration, or other comparable
regulatory authorities, and for which, if any, indications,
competition from other biotechnology companies, the company’s
liquidity, its ability to successfully develop product candidates
through current and future milestones on the anticipated timeline,
if at all, past results from non-IND clinical studies not being
representative of future results, and other risks identified in the
company’s SEC filings, including Axcella’s 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)
December 31,
December 31,
2019
2018
Assets:
Cash and cash equivalents
$
92,053
$
79,466
Other assets
2,306
2,378
Total assets
$
94,359
$
81,844
Liabilities and stockholders' equity
(deficit):
Liabilities
$
34,135
$
33,755
Preferred stock
—
197,842
Stockholders' equity (deficit)
60,224
(149,753
)
Total liabilities and stockholders'
equity
$
94,359
$
81,844
Axcella Health Inc.
Unaudited Condensed
Consolidated Statements of Operations
(in thousands, except share
and per share data)
Three Months Ended
Year Ended
December 31,
December 31,
2019
2018
2019
2018
Operating expenses:
Research and development
$
10,758
$
7,877
$
41,658
$
25,486
General and administrative
4,582
1,286
15,781
8,410
Total operating expenses
15,340
9,163
57,439
33,896
Loss from operations
(15,340
)
(9,163
)
(57,439
)
(33,896
)
Other income (expense):
Change in fair value of preferred stock
warrant liability
—
(60)
(51
)
(14)
Interest income (expense), net
(373
)
(539
)
(1,547
)
(2,159
)
Total other income (expense), net
(373
)
(599
)
(1,598
)
(2,173
)
Net loss
$
(15,713
)
$
(9,762
)
$
(59,037
)
$
(36,069
)
Net loss per share, basic and diluted
$
(0.68
)
$
(2.05
)
$
(3.55
)
$
(7.97
)
Weighted average common shares
outstanding, basic and diluted
23,137,014
4,772,964
16,624,941
4,546,373
View source
version on businesswire.com: https://www.businesswire.com/news/home/20200323005657/en/
Company/Investor Contact Jason Fredette
jfredette@axcellahealth.com (857) 320-2236
Media Contact Azeem Zeekrya HDMZ azeem.zeekrya@hdmz.com
(312) 506-5244
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