- AXA1665 IND application cleared by FDA for the reduction in
risk of recurrent OHE
- AXA1125 IND application cleared by FDA for the treatment of
NASH
- Initiation of AXA1665 Phase 2 and AXA1125 Phase 2b clinical
trials expected shortly
- 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 first quarter ended March
31, 2021 and provided a business update.
“Already in 2021, we have made tremendous progress in advancing
our EMM platform and our mission to bring new multi-targeted
therapies to patients with complex diseases and conditions,” said
Bill Hinshaw, President and Chief Executive Officer of Axcella.
“The recent clearance of our first two investigational new drug
(IND) applications has extended our strong track record of
execution. Additionally, these milestones validate how we can
efficiently compile a significant amount of clinical data and then
rapidly progress into later-stage development. We expect to
continue our momentum as we get our later-stage clinical trials in
overt hepatic encephalopathy (OHE) and nonalcoholic steatohepatitis
(NASH) underway this quarter, ramp up enrollment leveraging a
physician network that is excited by our approach and modality, and
expand Axcella’s pipeline of EMM compositions.”
Recent Accomplishments and Next
Steps
AXA1665 for the Reduction in Risk of Recurrent OHE
- Cleared IND: In January 2021, Axcella’s IND
application was cleared by the U.S. Food and Drug Administration
(FDA) for AXA1665, the company’s oral product candidate for
OHE.
- Readied for Phase 2 Clinical Trial: During the
first quarter of 2021, Axcella finalized plans for a 24-week Phase
2 clinical trial of AXA1665 that will enroll patients with a
history of OHE. Initiation of this trial is expected in the near
future.
- Accepted for DDW 2021 Oral Presentation: Data
from Axcella’s AXA1665-002 clinical study were accepted for an oral
presentation at the Digestive Disease Week (DDW) 2021 Annual
Meeting, which will be held virtually from May 21 to 23, 2021.
AXA1125 for the Treatment of NASH
- Cleared IND: In April 2021, Axcella’s
investigational new drug (IND) application was cleared by the FDA
for AXA1125, the company’s oral product candidate for NASH.
- Readied for Phase 2b Clinical Trial: During the
first quarter of 2021, Axcella finalized plans for a 48-week Phase
2b serial biopsy clinical trial of AXA1125 that will enroll adult
patients with NASH, with primary and secondary endpoints based on
liver histology. Initiation of this trial is expected in the near
future.
- Presented Data at NASH-TAG 2021: In March 2021,
multiple presentations regarding AXA1125 were included in NASH-TAG
2021, an event bringing clinicians and researchers together to
focus on the diagnosis and treatment of NASH and liver fibrosis.
Among them was a poster presentation providing novel insights
regarding AXA1125’s multi-targeted mechanism of action and a
AXA1125-003 clinical study data presentation that was recognized
with a Distinguished Abstract and Poster Award.
Management Team
- Added Dr. Alison Schecter as President of
R&D: In March 2021, Axcella announced the
appointment of Alison D. Schecter, M.D., as the company’s President
of Research and Development. In this role, Dr. Schecter oversees
all of the company’s research, product candidate design, clinical
and regulatory efforts. She brings more than 20 years of research,
clinical and regulatory experience to Axcella at companies such as
Sanofi-Genzyme, Johnson & Johnson, Selecta Biosciences, and
Novartis.
Financial Results
Cash Position: As of March 31, 2021, cash, cash
equivalents, and marketable securities totaled $93.0 million,
compared to $107.3 million at December 31, 2020. Axcella expects
that its 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 were
$10.2 million and $10.3 million for the quarters ended March 31,
2021 and 2020, respectively.
G&A Expenses: General and administrative expenses
were $4.3 million and $4.1 million for the quarters ended March 31,
2021 and 2020, respectively.
Net Loss: Net loss for the quarter ended March 31, 2021
was $15.2 million, or $0.40 per basic and diluted share. This
compares with a net loss of $15.0 million, or $0.65 per basic and
diluted share, for the quarter ended March 31, 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
Studies
Each of the company’s clinical studies to date are or 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 were not designed or intended to
evaluate a product candidate’s ability to diagnose, cure, mitigate,
treat or prevent a disease. INDs were recently cleared for
Axcella’s lead product candidates, AXA1665 and AXA1125, allowing
for the investigation of efficacy, safety and tolerability in
subsequent 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 potential for our product candidates to improve
the quality of life for patients with complex diseases, the status
and timing of the company’s planned Phase 2 clinical trial of
AXA1665 and planned Phase 2b clinical trial of AXA1125, and the
company’s expected cash runway into the third quarter of 2022. 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)
March 31,
December 31,
2021
2020
Assets:
Cash and cash equivalents
$
43,049
$
71,590
Marketable securities
49,909
35,739
Other assets
1,522
2,263
Total assets
$
94,480
$
109,592
Liabilities and stockholders' equity:
Liabilities
$
32,822
$
34,211
Stockholders' equity
61,658
75,381
Total liabilities and stockholders'
equity
$
94,480
$
109,592
Axcella Health Inc.
Unaudited Condensed
Consolidated Statements of Operations
(in thousands, except share
and per share data)
Three Months Ended March
31,
2021
2020
Operating expenses:
Research and development
$
10,240
$
10,335
General and administrative
4,256
4,125
Total operating expenses
14,496
14,460
Loss from operations
(14,496
)
(14,460
)
Other income (expense):
Interest income (expense) and other income
(expense), net
(693
)
(549
)
Total other income (expense), net
(693
)
(549
)
Net loss
$
(15,189
)
$
(15,009
)
Net loss per share, basic and diluted
$
(0.40
)
$
(0.65
)
Weighted average common shares
outstanding, basic and diluted
37,652,158
23,188,816
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version on businesswire.com: https://www.businesswire.com/news/home/20210506005368/en/
Jason Fredette jfredette@axcellahealth.com (857) 320-2236
Axcella Health (NASDAQ:AXLA)
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