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.