24
In addition to our chronic
disease pipeline, we are advancing
an infectious disease product candidate,
UB-612, as a heterologous booster
vaccine for
SARS-CoV-2.
We
have reported
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 global Phase 3
heterologous booster trial of
UB-612
that began in the first half of 2022.
We have principally funded our
operations through financing
transactions. Through June 30, 2022,
we received gross
proceeds of $306.1
million in connection with various financial instruments, including
the sale of preferred and common stock, the issuance of promissory
notes (including
convertible promissory
notes (“Convertible
Notes”)), the
entry into
simple agreements
for future
equity (“SAFEs”),
and proceeds from our initial public offering
.
Additionally, we have been
awarded grants totaling $10.1 million from the Coalition
for
Epidemic Preparedness Innovations and
the Michael J. Fox Foundation.
The Company will continue to pursue
non-dilutive sources of
financing,
including
grants,
collaboration
agreements,
and revenue
from
the
sale of
our
products.
However,
our
ability to
generate
revenue sufficient to
achieve profitability will depend on
the eventual regulatory approval, and
successful commercialization of one or
more of our product candidates. To
date, we have not yet obtained any regulatory approvals for our pipeline product
candidates.
Costs associated with research and development are the most significant component of our expenses. These costs can vary greatly from
period to period depending on
the timing of various
trials for our product
candidates. We expect our general and administrative expenses
to incur
increased costs
as a
result of
operating as
a public
company and
allocated research
and development
costs to
be in
line with
recent levels over
the next 12
months and to
thereafter increase over
time as we
expand the number
of product candidates
that we are
advancing,
whether
exclusively
or
with
partners.
Further,
we
anticipate
incurring
greater
selling
and
marketing
expenses
if
we
commercialize any of our
product candidates in
the future. Our product
candidates are in
clinical stage or
pre-clinical stage development,
and we
have generated
limited revenue
to date
and have
incurred significant
operating losses
since inception.
Net losses
were $17.3
million and
$26.9 million
for the
three months
ended June 30,
2022 and
2021, respectively.
Net losses
were $35.5
million and
$58.9
million for the
six months ended
June 30, 2022 and
2021, respectively.
As of June 30,
2022, we had
an accumulated deficit
of $265.0
million. Our
expenses and capital requirements may increase over time in connection with our operations,
which include:
•
continuing pre-clinical studies, existing
clinical trials, and initiating
new clinical trials
for product candidates, including clinical
trials of UB-313 and VXX-401;
•
commercializing UB-612 and meeting post-marketing regulatory
commitments;
•
hiring additional clinical, quality control, medical, scientific and other technical personnel
to support clinical and research and
development programs;
•
expanding operational, financial and management systems
and infrastructure, expanding our facilities
and increasing personnel
to support operations;
•
maintaining, expanding and protecting our intellectual property portfolio;
•
seeking regulatory approvals for any product candidates that successfully complete
clinical trials; and
•
undertaking pre-commercialization activities to establish sales, marketing
,
pharmacovigilance and distribution capabilities for
any product candidates for which we may receive regulatory approval in
regions where we elect to commercialize products
on our own or jointly with third parties.
As of
the date
of this
Report, we
expect our
existing cash
and cash
equivalents will
be sufficient
to fund
our operating
expenses and
capital expenditure
requirements for
at least
the next 12
months. We
believe that
cash and
cash equivalents
on hand
will enable
us to
fund our operating
expenses and capital requirements
into the second
half of 2023. Thereafter,
our viability will
depend on our
ability
to raise additional capital to finance operations through
debt or equity raises, or non-dilutive sources such as grants,
successful product
commercialization and/or collaborations with third parties for the development
of our product candidates. If we are unable to do any of
the foregoing, we would
be forced to delay,
limit, reduce or terminate
our product candidate development
or future commercialization
efforts.
Our estimates
are based
on a
variety of
assumptions that
may prove
to be
wrong, and
we could
exhaust our
available capital
resources sooner than expected. See “— Liquidity and Capital Resources.”
Business Update Regarding COVID-19 Pandemic
In March
2020, the
World
Health Organization
declared the
COVID-19 outbreak
a pandemic.
The onset
of the
pandemic led
to our
institutional
prioritization
of
COVID-19
vaccine
development
efforts,
which
correlated
to
a
decline
in
research
and
development
expenditures for our
chronic disease product candidates.
To date,
our operations have not
been negatively impacted
by the COVID-19
pandemic in a material manner. However,
at this time, we cannot predict the specific extent, duration or full impact that the COVID-19
pandemic will
have on
our financial
condition and
operations, but
the development
of clinical
supply materials
could be
delayed and
enrollment of patients in our studies may be delayed or suspended, as hospitals and
clinics in areas where we are conducting trials shift
