22
and general and administrative expenses could increase over time
if we expand the number of product candidates
that we are advancing,
advance any of the current pipeline candidates to later stage clinical trials which typically have more subjects and higher costs, or incur
increased costs as a result
of operating as a
public company.
Further, we anticipate
incurring greater selling and
marketing expenses if
we commercialize
any of
our product
candidates in
the future
and prepare
for such commercialization.
Our product
candidates are
in
clinical
stage or
pre-clinical
stage
development.
We
have
generated
limited revenue
to
date
and
have incurred
significant
operating
losses since inception. Net
losses were $14.0 million
and $17.3 million for the
three months ended June 30, 2023
and 2022, respectively.
Net losses were
$32.4 million
and $35.5 million
for the six
months ended June
30, 2023
and 2022, respectively.
As of June 30,
2023,
we had an
accumulated deficit of $337.1
million. We expec
t our expenses
and capital requirements may
increase over time in
connection
with our planned operations, which include:
•
continuing pre-clinical studies, existing clinical trials, or initiating new clinical trials
for product candidates UB-312, UB-313,
VXX-401, UB-612, and other product candidates;
•
hiring additional
clinical, quality
control,
medical, scientific
and other
technical personnel
to support
additional clinical
and
research and development programs;
•
expanding operational, financial and management systems
and infrastructure, expanding our facilities and
increasing personnel
to support operations;
•
undertaking actions to meet the requirements and demands of being a public company;
•
maintaining, expanding and protecting our intellectual property portfolio;
•
seeking regulatory approvals for any product candidates that successfully complete clinical
trials; and
•
undertaking pre-commercialization and commercialization
activities to establish sales,
marketing 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
and our short-term
investments, together
with the plans
described above, will be sufficient
to fund our operating expenses
and capital expenditure requirements
for at least the next 12
months
and into mid-2024. See Note 1 to the consolidated financial statements.
Thereafter, our
viability will
depend on our
ability to raise
additional capital
to finance operations,
to successfully commercialize
our
product candidates,
if approved, or
to enter into
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.”
Recent Developments
On June 22, 2023, we announced positive results from Part B of the Phase 1 clinical trial
of UB-312, which showed that UB-312 was
well-tolerated and induced anti-alpha-synuclein (“aSyn”) antibody responses in participants
with early PD, meeting the primary
objectives of the trial.
92% of patients (12 out of 13) who completed dosing with UB-312 developed
anti-aSyn antibodies.
UB-312
had an overall adverse event profile similar to placebo.
Two patients experienced
serious adverse events (“SAEs”).
Only one SAE,
deep vein thrombosis, was deemed possibly related to the trial by the investigator,
and all SAEs were resolved. Anti-aSyn antibodies
were also detectable in the cerebrospinal fluid (“CSF”) of patients.
On July 17,
2023, we announced
additional data
from the Phase
1 clinical
trial of
UB-312 showing
that antibodies
derived from UB-
312 slow seeding of
aSyn in the
CSF of patients
with PD, as demonstrated
using multiple target
engagement assays.
UB-312-derived
antibodies showed preferential
binding to aggregated
aSyn isolated
from patients with
PD and Multiple
System Atrophy (“MSA”),
as
observed by dot blot. Preclinical data published in Alzheimer’s Research & Therapy in 2020 showed similar characteristics of UB-312-
derived
antibodies.
UB-312-derived
antibodies
also
successfully
demonstrated
inhibition
of
aSyn
aggregation
in
both
a
seed
amplification assay
(“SAA”) and
a protein
misfolding cyclic
amplification assay
(“PMCA”).
Finally,
aSyn aggregation
was slowed
down in CSF samples from PD patients who received UB-312, as compared
to those who received placebo, in the Phase 1 trial.
Interim results from the ongoing Phase 1 trial
of UB-313, our anti-CGRP candidate for migraine, show
that UB-313 was generally well-
tolerated and immunogenic in healthy volunteers.
The primary objectives of the trial are safety and tolerability,
as assessed by adverse
events, and
immunogenicity, as assessed by
serum anti-CGRP antibody
titers.
The secondary
objective is inhibition
of capsaicin-induced
dermal blood flow.
All subjects who received three doses of UB-313 (31 out of 31) developed anti-CGRP antibodies.
Despite a 100%
responder rate, the subjects did not
produce a level of serum
antibody titers we had expected based
on preclinical studies or as compared
to clinical results from
our other clinical programs.
For instance, the
titers induced by
UB-313 were on
average over 100
times lower