Blog: AXCELLA HEALTH INC. : Regulation FD Disclosure, Other Events, Financial Statements and Exhibits (form 8-K) –

Item 7.01 Regulation FD Disclosure.

On August 2, 2022, Axcella Health Inc. (the “Company” or “Axcella”) issued a
press release announcing top-line data from its Phase 2a clinical trial of
AXA1125 for the treatment of Long COVID entitled “Axcella Announces Results from
Phase 2a Clinical Trial for Long COVID.” The Company also hosted a conference
call to discuss the top-line data results on Tuesday, August 2, 2022 at 8:00
a.m. Eastern Time. Copies of the press release and presentation are attached as
Exhibits 99.1 and 99.2, respectively, to this Current Report on Form 8-K and are
incorporated herein by reference.

The information in this Item 7.01 and Exhibits 99.1 and 99.2 attached hereto
shall not be deemed “filed” for purposes of Section 18 of the Securities and
Exchange Act of 1934, as amended, or otherwise subject to the liabilities of
that section, nor shall they be deemed incorporated by reference in any filing
under the Securities Act of 1933, as amended, or the Exchange Act, except as
expressly set forth by specific reference in such filing.

Item 8.01 Other Events.

On August 2, 2022, the Company reported topline results from the Phase 2a
randomized, double-blind, placebo-controlled investigation to evaluate the
efficacy and safety of AXA1125 in patients with fatigue related to Long COVID.

In the study, 41 subjects were enrolled and randomized to receive either 67.8
grams per day of AXA1125 (N=21) or a matched placebo (N=20) in two divided doses
for 28 days, with a one-week safety follow-up period. All 41 subjects who
started the study remained in the study to completion. Endpoints included
phosphocreatine recovery time (PCr?) following moderate exercise as assessed by
31P-magnetic resonance spectroscopy (MRS), which was included to assess
mitochondrial function, and most importantly, clinically relevant endpoints
including self-reported mental and physical fatigue as assessed by the Chalder
Fatigue Questionnaire (CFQ-11), 6 minute walk test (6MWT) as well as serum
lactate levels. The CFQ-11 is a validated patient reported outcome measure of
fatigue that has been used in measuring patient impact in fatigue states such as
chronic fatigue syndrome.

Subjects who received AXA1125 had improvements in measures of mental and
physical fatigue that were both highly statistically significant and clinically
relevant compared to those who received placebo. Mean changes in total, physical
and mental scores in the CFQ-11 versus placebo were -4.30 (p=0.0039), -2.94
(p=0.0097) and -1.32 (p=0.0097), respectively. Clinically meaningful shifts in
the severity of physical and mental fatigue were also noted in subjects who
received AXA1125 compared to those who received placebo. There was a
statistically significant correlation of improvement in fatigue score and
greater distance achieved in the 6MWT (p=0.0027), an objective measure of
physical ability, only observed in subjects who received AXA1125 when compared
to those receiving placebo.

Baseline PCr? among all subjects was significantly higher and had a higher
degree of inter-subject variability (92.46 S + 35.3 S) than previously reported
in the literature. These findings support the hypothesis that there is
significant mitochondrial dysfunction in these patients but limits the utility
of this parameter in a clinical trial. The trial did not meet its exploratory
primary endpoint of showing a change from baseline to week four in the PCr?
recovery rate following moderate exercise between subjects receiving AXA1125 and
placebo. There was a notable trend toward significant improvement in serum
lactate levels after a 6MWT in AXA1125 subjects (p=0.0730). AXA1125 was safe and
well tolerated with no significant emergent adverse events or serious adverse
events reported by study subjects.

Cautionary Note Regarding Forward-Looking Statements

This Form 8-K contains forward-looking statements within the meaning of the
Private Securities Litigation Reform Act of 1995, as amended, including, without
limitation, statements regarding interest that may ensue in the Company’s
product candidates or securities following announcement of the Company’s recent
clinical trial results and the timing of the Company’s clinical trial data
readouts and next steps for its clinical programs, including a potential
registration trial of AXA1125 for the treatment of Long COVID. 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 Form 8-K 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 Form 8-K, including, without limitation, those related to the belief that
mitochondrial dysfunction is a key driver of Long COVID induced fatigue,
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 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 AXA1125, the clinical development and safety profile of AXA1125 and its
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 Reports 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 Form 8-K 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

Item 9.01 Financial Statements and Exhibits.

(d) Exhibits.

 Number                                  Description
  99.1        Press Release dated August 2, 2022 entitled "Axcella Announces
            Results from Phase 2a Clinical Trial for Long COVID"
  99.2        Presentation of Axcella Health, Inc., doing business as "Axcella
            Therapeutics," dated August 2, 2022
104         Cover Page Interactive Data (embedded within the Inline XBRL document)

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