22
Item 2. Management’s Discussion and Analysis of
Financial Condition and Results of Operations.
The following discussion and analysis of our financial condition and
results of operations should be rea
d
together with our unaudited
condensed consolidated financial statements and related
notes and other financial information appearing elsewhere
in this Quarterly
Report. We
intend for this discussion to provide you with information that
will assist you in understanding our unaudited condensed
consolidated financial statements, the changes in key items in those unaudited
condensed consolidated financial statements from
period to period and the primary factors that accounted for those changes.
Some of the information contained in this discussion and
analysis or set forth elsewhere in this Quarterly
Report, including information with respect to
our plans and strategy for our business
and related financing, includes forward
-looking statements that involve risks, uncertainties and assumptions.
See the section of this
Quarterly Report titled “Special Note Regarding
Forward-Looking Statements” for a discussion of
forward-looking statements. As a
result of many factors, including those factors set forth
in the “Risk Factors” section of this Quarterly Report, our actual results
could
differ materially from management’s
expectations and the results described in or implied by
the forward-looking statements contained
in the following discussion and analysis.
Overview
Vaxxinity
is engaged in the development and commercialization of rationally designed prophylactic and therapeutic vaccines to combat
chronic
disorders and
infectious diseases
with large
patient populations
and unmet
medical needs.
While vaccines
have traditionally
been unable
to effectively
and safely
combat chronic
diseases, we
believe our
platform could
overcome the
traditional hurdles
facing
vaccines in this area.
Our Vaxxine
Platform relies on a synthetic peptide
vaccine technology first developed by
UBI and subsequently
refined over the last
two decades. We
believe our vaccines have
the potential to combat
conditions that have not
yet been successfully
treated, or which have primarily
been addressed with monoclonal antibodies
(“mAbs”) which, while generally
effective, are extremely
costly and cumbersome to administer,
and thus have limited accessibility.
Our pipeline primarily consists of five programs focused
on
chronic disease, particularly
neurodegenerative disorders, in
addition to other
neurology and cardiovascular
indications. Given the
global
COVID-19 pandemic and our Vaxxine
Platform’s applicability to infectious disease, we
are also opportunistically advancing a product
candidate that addresses SARS-CoV-2.
We separated our business from UBI
through two transactions:
a spin-out from UBI
in 2014 of
operations focused on
developing chronic
disease product candidates that resulted
in UNS, and a second spin-out
from UBI in 2020 of operations
focused on the development of
a COVID-19 vaccine that resulted in COVAXX.
On February 2, 2021, Vaxxinity
was incorporated for the purpose of reorganizing and
combining UNS and
COVAXX
and did so on
March 2, 2021 through
the Reorganization. The
Reorganization was determined
to be a
common control transaction,
so the
carrying values of
all contributed assets
and assumed liabilities
remained unchanged and
the financial
information for all
periods in this
section of the
financial statements presented
prior to the
Reorganization are presented on
a consolidated
basis. Unless the context
requires otherwise, in this section
we use the terms
“Vaxxinity,”
“we,” “us” and “our”
to refer to our
operations
(including through UNS and COVAXX)
both prior to and after the Reorganization.
Since our spin-out transactions
from UBI, we have
focused on organizing
and staffing our business,
business planning, raising
capital,
developing our Vaxxine
Platform and pipeline candidates,
identifying and testing
potential product candidates
and conducting clinical
trials. We have also
developed a SARS CoV-2
antibody ELISA test, which received an EUA from the FDA in January 2021.
Our current pipeline consists of six programs from early to late-stage
development, including five programs focused on chronic disease.
Our
neurodegenerative
chronic
disease
pipeline
has
three
primary
programs:
UB-311,
our
leading
neurology
product
candidate,
in
development for
Alzheimer’s Disease
(“AD”); UB-312,
in development
for Parkinson’s
Disease (“PD”)
and other
synucleinopathies;
and an anti-tau product candidate
which has the potential to
address multiple neurodegenerative conditions, including AD. Additionally,
we have
two other
primary
programs
focused on
chronic
disease: UB-313,
which
targets
CGRP to
prevent
migraines; and
our anti-
PCSK9 program,
which targets
hypercholesterolemia to
reduce the risk
of cardiac
events. Through
our Vaxxine
Platform, we
believe
we may be able to
address a wide range of
other chronic diseases, including chronic diseases
that are or could potentially
be successfully
treated by mAbs, which increasingly dominate the treatment paradigm
for many chronic diseases.
In addition
to our
chronic
disease pipeline,
given
our
Vaxxine
Platform’s
applicability
to infectious
disease and
the global
need
for
additional vaccines to address
SARS-CoV-2, we are advancing an infectious disease
product candidate. We have reported interim
results
of our
UB-612 Phase
1, Phase
2, and
Phase 1
extension clinical
trials. An
EUA application
for UB-612
was denied
by the
TFDA in
August 2021.
We
are pursuing
accelerated pathways
to authorization
with regulators
in multiple
jurisdictions, including
high income
countries and LMICs, based on a Phase 3 heterologous booster trial of UB-612
that began in the first half of 2022.
To
date, our revenue
has been generated
from the modest
sales of our
ELISA test and
the sale of
an option to
negotiate a license
with
UNS (which option
has expired). As
a result,
our ability to
generate revenue sufficient to
achieve profitability will
depend on the
eventual
regulatory approval, and
commercialization of one
or more of
our product candidates.
We have not yet obtained
any regulatory approvals
for our pipeline product candidates.