- Completed $25 million registered direct stock offering priced
at the market
- Initiated Phase 2a Long COVID clinical trial
- Fast Track designation received from FDA for AXA1125 in NASH
with liver fibrosis
- Enhanced management team
- Long COVID top-line data and NASH interim data expected in the
third quarter of 2022
- Company to host conference call at 8:30 a.m. ET today
Axcella Therapeutics (Nasdaq: AXLA), a clinical-stage
biotechnology company pioneering a new approach to treat complex
diseases using multi-targeted endogenous metabolic modulator (EMM)
compositions, today announced financial results for the fourth
quarter and full year ended December 31, 2021 and provided a
business update.
“The year 2021 was one of significant accomplishment for Axcella
Therapeutics that was highlighted by the initiation of three
distinct Phase 2 trials in non-alcoholic steatohepatitis (NASH),
overt hepatic encephalopathy (OHE), and our newest area of focus,
Long COVID. We were pleased to continue our momentum in early 2022
by obtaining Fast Track designation for AXA1125 in NASH with liver
fibrosis,” said Bill Hinshaw, President and Chief Executive Officer
of Axcella. “A data-rich period is now fast approaching, with both
our Long COVID Phase 2a top-line results and NASH Phase 2b interim
results anticipated in the third quarter. With these steps, a
recently strengthened balance sheet and other potential value
drivers on the near-term horizon, we believe the stage has been set
for a transformational 2022.”
Recent Accomplishments and Developments
- Initiated Long COVID Phase 2a Clinical Trial: Axcella
initiated patient enrollment and dosing in a Phase 2a trial that is
investigating AXA1125 as a potential oral treatment for patients
with exertional fatigue related to Long COVID. Fatigue is the most
common symptom associated with Long COVID, impacting a majority of
patients. This randomized, double-blind, placebo-controlled trial
is enrolling approximately 40 patients at the University of Oxford
in the United Kingdom who are receiving AXA1125 or a matched
placebo for 28 days with a one-week safety follow-up period.
- Obtained Fast Track Designation for AXA1125: The U.S.
Food and Drug Administration (FDA) recently granted a Fast Track
designation to AXA1125 for the treatment of NASH with liver
fibrosis. Fast Track is a process designed by the FDA to facilitate
the development and expedite the review of drugs to treat serious
or life-threatening conditions with unmet medical needs.
- Presented Data at The Liver Meeting® 2021: Posters were
presented about Axcella’s programs at The Liver Meeting® 2021, the
Annual Meeting of the American Association for the Study of Liver
Diseases (AASLD), which took place virtually November 12-15, 2021.
One of the presentations focused on the amino acid signature of
AXA1665 and the other featured predictive metabolic modeling for
AXA1125.
- Progressed Screening and Enrollment in EMMPACT℠ and
EMMPOWER℠ Clinical Trials:
- EMMPACT is a global 48-week, randomized, double-blind,
placebo-controlled Phase 2b clinical trial that is evaluating the
efficacy and safety of AXA1125 in approximately 270 patients with
biopsy-confirmed F2/F3 NASH.
- EMMPOWER is a global 24-week, randomized, double-blind,
placebo-controlled Phase 2 clinical trial that 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.
- Strengthened Management: Margaret Koziel, M.D., was
promoted to the role of Chief Medical Officer. Dr. Koziel, who
previously served as Axcella’s Vice President, Clinical
Development, has a wealth of leadership experience within both
biopharma and academia. Additionally, Robert Crane was appointed as
the company’s new Chief Financial Officer. Mr. Crane brings to
Axcella over 35 years of experience building therapeutics,
diagnostics and medical device companies.
- Enhanced Balance Sheet: Axcella completed a registered
direct offering in March 2022. In this transaction, 13,089,002
shares of the company’s common stock were sold at the market for a
purchase price of $1.91 per share, yielding gross proceeds of
approximately $25.0 million.
Financial Results
Cash Position: As of December 31, 2021, cash, cash
equivalents, and marketable securities totaled $55.0 million,
compared to $107.3 million as of December 31, 2020. As mentioned
above, subsequent to the close of 2021, the company received
approximately $25.0 million in gross proceeds from a registered
direct offering of common stock. Axcella expects that its current
cash balance will be sufficient to meet its operating needs into
2023.
R&D Expenses: Research and development expenses for
the quarter and year ended December 31, 2021 were $12.5 million and
$43.1 million, respectively. Research and development expenses for
the same periods ended December 31, 2020 were $10.6 million and
$37.0 million. These increases are primarily the result of the
initiation of the company’s EMMPOWER, EMMPACT and Long COVID Phase
2 clinical trials.
G&A Expenses: General and administrative expenses for
the quarter and year ended December 31, 2021 were $4.7 million and
$18.7 million, respectively. General and administrative expenses
for the same periods ended December 31, 2020 were $3.9 million and
$16.8 million. These increases are primarily the result of greater
non-cash stock-based compensation expenses.
Net Loss: Net loss for the quarter and year ended
December 31, 2021 was $17.9 million, or $0.46 per basic and diluted
share, and $64.6 million, or $1.70 per basic and diluted share,
respectively. This compares with a net loss of $15.2 million, or
$0.40 per basic and diluted share, and $56.5 million, or $1.78 per
basic and diluted share, for the quarter and year ended December
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.axcellatx.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.
Internet Posting of Information Axcella uses the
“Investors and News” section of its website, www.axcellatx.com, as
a means of disclosing material nonpublic information, to
communicate with investors and the public, and for complying with
its disclosure obligations under Regulation FD. Such disclosures
include, but may not be limited to, investor presentations and
FAQs, Securities and Exchange Commission filings, press releases,
and public conference calls and webcasts. The information that we
post on our website could be deemed to be material information. As
a result, we encourage investors, the media and others interested
to review the information that we post there on a regular basis.
The contents of our website shall not be deemed incorporated by
reference in any filing under the Securities Act of 1933, as
amended.
About Axcella Therapeutics (Nasdaq: AXLA) Axcella is a
clinical-stage biotechnology company pioneering a new approach to
treat complex diseases using compositions of endogenous metabolic
modulators (EMMs). The company’s product candidates are comprised
of EMMs and derivatives that are engineered in distinct
combinations and ratios to reset multiple biological pathways,
improve cellular energetics, and restore homeostasis. Axcella’s
pipeline includes lead therapeutic candidates in Phase 2
development for the treatment of Long COVID and non-alcoholic
steatohepatitis (NASH), and the reduction in risk of overt hepatic
encephalopathy (OHE) recurrence. The company’s unique model allows
for the evaluation of its EMM compositions through non-IND clinical
studies or IND clinical trials. For more information, please visit
www.axcellatx.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 timing of the
company’s clinical trial data readouts and its 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 Therapeutics
Unaudited Condensed
Consolidated Balance Sheets
(in thousands)
December 31,
December 31,
2021
2020
Assets:
Cash and cash equivalents
$
23,574
$
71,590
Marketable securities
31,474
35,739
Other assets
2,679
2,263
Total assets
$
57,727
$
109,592
Liabilities and stockholders' equity:
Liabilities
$
35,719
$
34,211
Stockholders' equity
22,008
75,381
Total liabilities and stockholders'
equity
$
57,727
$
109,592
Axcella Therapeutics
Unaudited Condensed
Consolidated Statements of Operations
(in thousands, except share
and per share data)
Three Months Ended December
31,
Year Ended December
31,
2021
2020
2021
2020
Operating expenses:
Research and development
$
12,467
$
10,598
$
43,135
$
37,039
General and administrative
4,736
3,869
18,711
16,797
Total operating expenses
17,203
14,467
61,846
53,836
Loss from operations
(17,203
)
(14,467
)
(61,846
)
(53,836
)
Other income (expense):
Interest income (expense) and other income
(expense), net
(688
)
(722
)
(2,782
)
(2,691
)
Total other income (expense), net
(688
)
(722
)
(2,782
)
(2,691
)
Net loss
$
(17,891
)
$
(15,189
)
$
(64,628
)
$
(56,527
)
Net loss per share, basic and diluted
$
(0.46
)
$
(0.40
)
$
(1.70
)
$
(1.78
)
Weighted average common shares
outstanding, basic and diluted
38,847,669
37,536,350
38,110,420
31,747,676
View source
version on businesswire.com: https://www.businesswire.com/news/home/20220330005062/en/
Company Contact Jason Fredette jfredette@axcellatx.com
(857) 320-2236
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