- Initiated EMMPOWER Phase 2 clinical trial of AXA1665 for the
reduction in risk of recurrent OHE
- Initiated EMMPACT Phase 2b clinical trial of AXA1125 for the
treatment of NASH
- Presented data at key medical congresses
- Enhanced management team with the addition of Chief People
Officer
- Company to host conference call at 8:30 a.m. ET today
Axcella (Nasdaq: AXLA), a clinical-stage biotechnology company
pioneering a new approach to treat complex diseases and improve
health using endogenous metabolic modulator (EMM) compositions,
today announced financial results for the second quarter ended June
30, 2021 and provided a business update.
“Thanks to solid execution on the part of our team, Axcella has
rapidly advanced the development of its multi-targeted EMM
compositions in order to address significant unmet needs for
patients with complex diseases,” said Bill Hinshaw, President and
Chief Executive Officer of Axcella. “Our progress continued in the
second quarter as we initiated the EMMPOWER Phase 2 clinical trial
of AXA1665 in overt hepatic encephalopathy (OHE) as well as the
EMMPACT Phase 2b clinical trial of AXA1125 in nonalcoholic
steatohepatitis (NASH). With a high level of interest and
engagement from the medical community and many clinical sites
already activated for each of these global trials, I am pleased to
report that we are off to a strong start. As we enter the second
half of 2021, maximizing clinical trial enrollment and expanding
Axcella’s pipeline are our primary areas of focus.”
Recent Accomplishments
AXA1665 for the Reduction in Risk of Recurrent OHE
- Initiated EMMPOWER Clinical Trial: Axcella
recently initiated its EMMPOWER Phase 2 clinical trial. This global
24-week, randomized, double-blind, placebo-controlled trial is
evaluating the efficacy and safety of AXA1665 in approximately 150
patients who have experienced at least one prior OHE event and have
neurocognitive dysfunction at screening.
- Presented Orally at DDW 2021: Data from Axcella’s
AXA1665-002 clinical study were highlighted in an oral presentation
at the Digestive Disease Week (DDW) 2021 Annual Meeting by Dr. Arun
Sanyal, Professor in the Virginia Commonwealth University (VCU)
Department of Internal Medicine and Education Core Director in the
VCU Center for Clinical and Translational Research.
AXA1125 for the Treatment of NASH
- Initiated EMMPACT Clinical Trial: In April, the
U.S. Food and Drug Administration (FDA) cleared an Investigational
New Drug (IND) application for AXA1125. Shortly thereafter, Axcella
initiated its EMMPACT Phase 2b clinical trial. This global 48-week,
randomized, double-blind, placebo-controlled trial is evaluating
the efficacy and safety of AXA1125 in approximately 270 patients
with biopsy-confirmed F2/F3 NASH.
- Published Findings in Nature’s Scientific Reports:
Nature’s Scientific Reports published findings from a systematic
evaluation of AXA1125’s EMM constituents across multiple primary
human cell model systems demonstrating that they consistently and
simultaneously impacted NASH-relevant metabolic, inflammatory and
fibrotic processes.
- Presented at ADA 81st Scientific Sessions:
Clinical and nonclinical data regarding the effects from AXA1125
and its EMM constituents on insulin sensitivity were included in a
poster presentation at the American Diabetes Association (ADA) 81st
Scientific Sessions.
Management Team
- Added Virginia Dean as Chief People Officer: In
June 2021, Axcella appointed Virginia Dean as the company’s Senior
Vice President and Chief People Officer. In this role, Ms. Dean is
leading the company’s organizational and cultural development
initiatives with responsibility for all human resources functions.
She previously headed up ClearSight Leadership, a consulting firm
specializing in HR services, and led the human resources functions
for several high-growth companies, including TESARO, Inc. and ARIAD
Pharmaceuticals.
Financial Results
Cash Position: As of June 30, 2021, cash, cash
equivalents, and marketable securities totaled $78.9 million,
compared to $107.3 million at December 31, 2020. Axcella continues
to expect that its existing cash balance will be sufficient to meet
the company’s operating needs into the third quarter of 2022.
R&D Expenses: Research and development expenses for
the quarter and six months ended June 30, 2021 were $10.3 million
and $20.5 million, respectively. Research and development expenses
for the same periods ended June 30, 2020 were $8.6 million and
$18.9 million. These increases are primarily the result of work
related to the initiations of the company’s EMMPOWER and EMMPACT
clinical trials.
G&A Expenses: General and administrative expenses for
the quarter and six months ended June 30, 2021 were $4.9 million
and $9.2 million, respectively. General and administrative expenses
for the same periods ended June 30, 2020 were $4.6 million and $8.7
million. These increases are primarily the result of greater
non-cash stock-based compensation expenses and benefit-related
costs.
Net Loss: Net loss for the quarter and six months ended
June 30, 2021 was $15.9 million, or $0.42 per basic and diluted
share, and $31.1 million, or $0.83 per basic and diluted share,
respectively. This compares with a net loss of $13.9 million, or
$0.48 per basic and diluted share, and $28.9 million, or $1.10 per
basic and diluted share, for the quarter and six months ended June
30, 2020.
Conference Call Reminder
Axcella will host a conference call today at 8:30 a.m. ET to
discuss the company’s financial results and other recent business
updates. The conference call webcast will be accessible in the
Investors & News section on the company’s website at
www.axcellahealth.com. To access the call via telephone, please
dial (844) 808-7139 (U.S. toll free) or (412) 902-0127
(international) five minutes prior to the start time. For those
unable to listen in live, a webcast archive will be available on
the company’s website for 90 days following the call.
About Endogenous Metabolic Modulators
(EMMs)
EMMs are a broad family of naturally occurring 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
underlying causes of various complex diseases and improve
health.
About Axcella’s Clinical
Development
Each of the clinical investigations that the company has
completed to date have been conducted as non-investigational new
drug application (IND) “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 and when
Axcella decides to develop a product candidate as a potential
therapeutic, as is the case with AXA1665 and AXA1125, the company
will seek an IND to enable the initiation of “clinical trials.”
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 this portion
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 pioneering a
new approach to treat complex diseases and improve health using
endogenous metabolic modulator (EMM) compositions. 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. 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 AXA1665, AXA1125 and potential future EMM
compositions, the company’s ability to enroll its EMMPOWER and
EMMPACT clinical trials in a timely manner, its ability to expand
the company’s pipeline, and the company’s expected cash runway. 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 clinical trials 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 the company is able to
collect in its clinical trials of AXA1665 and AXA1125, other
potential impacts of COVID-19 on the company’s business and
financial results, including with respect to its ability to raise
additional capital and operational disruptions or delays, changes
in law, regulations, or interpretations and enforcement of
regulatory guidance, whether data readouts support the company’s
clinical trial plans and timing, clinical trial design and target
indications for AXA1665 and AXA1125, the clinical development and
safety profile of AXA1665 and AXA1125 and their therapeutic
potential, whether and when, if at all, the company’s product
candidates will receive approval from the FDA or other comparable
regulatory authorities, potential competition from other biopharma
companies in the company’s target indications, 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)
June 30,
December 31,
2021
2020
Assets:
Cash and cash equivalents
$
33,940
$
71,590
Marketable securities
45,003
35,739
Other assets
2,541
2,263
Total assets
$
81,484
$
109,592
Liabilities and stockholders' equity:
Liabilities
$
33,397
$
34,211
Stockholders' equity
48,087
75,381
Total liabilities and stockholders'
equity
$
81,484
$
109,592
Axcella Health Inc.
Unaudited Condensed
Consolidated Statements of Operations
(in thousands, except share
and per share data)
Three Months Ended June
30,
Six Months Ended June
30,
2021
2020
2021
2020
Operating expenses:
Research and development
$
10,298
$
8,565
$
20,538
$
18,900
General and administrative
4,946
4,619
9,202
8,744
Total operating expenses
15,244
13,184
29,740
27,644
Loss from operations
(15,244
)
(13,184
)
(29,740
)
(27,644
)
Other income (expense):
Interest income (expense) and other income
(expense), net
(691
)
(708
)
(1,384
)
(1,257
)
Total other income (expense), net
(691
)
(708
)
(1,384
)
(1,257
)
Net loss
$
(15,935
)
$
(13,892
)
$
(31,124
)
$
(28,901
)
Net loss per share, basic and diluted
$
(0.42
)
$
(0.48
)
$
(0.83
)
$
(1.10
)
Weighted average common shares
outstanding, basic and diluted
37,732,196
29,202,367
37,692,398
26,195,591
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version on businesswire.com: https://www.businesswire.com/news/home/20210729005112/en/
Jason Fredette jfredette@axcellahealth.com (857) 320-2236
Axcella Health (NASDAQ:AXLA)
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