Vaxxinity Reports Second Quarter 2022 Financial Results and Provides Corporate Updates
August 11 2022 - 8:00AM
Vaxxinity, Inc. (Nasdaq: VAXX), a U.S. company pioneering the
development of a new class of immunotherapeutic vaccines, today
reported financial results for the second quarter ended June 30,
2022.
“We continue to advance our vaccine candidates further in
clinical development and are delighted with the recent progress. We
recently enrolled the first set of subjects into a Phase 1 clinical
trial to study UB-313, our anti-CGRP candidate for migraine, and
announced preclinical proof-of-concept data for our latest vaccine
candidate, VXX-401, which demonstrated a significant reduction in
cholesterol over a sustained period, further showcasing the
capabilities of our platform in chronic diseases,” said Mei Mei Hu,
CEO of Vaxxinity. “We remain diligent on strengthening our
execution to advance the company’s pipeline and look forward to
sharing clinical data updates in the second half of this year,
including UB-312 in Parkinson’s disease, as well as our COVID-19
heterologous booster, UB-612.”
Second Quarter 2022 and Recent Updates
UB-311 FDA Fast Track Designation Granted
- UB-311 targets toxic forms of aggregated amyloid-β in the brain
to fight Alzheimer’s disease (AD).
- In May 2022, UB-311 received Fast Track designation from the
FDA for the treatment of AD. This designation will facilitate the
development and expedite the review of UB-311.
- Vaxxinity plans to advance UB-311 into a registration-quality
Ph2b early AD treatment trial, and other pivotal development, with
a strategic partner, which may affect the trial initiation
timeline.
UB-312 Phase 1 Clinical Trial Part B Completes Last
Patient Last Dose
- UB-312 targets toxic forms of aggregated α-synuclein in the
brain to fight Parkinson’s disease (PD) and other
synucleinopathies.
- Phase 1 Part B trial evaluating UB-312 in PD has completed last
patient last dose. Vaxxinity expects to complete an
end-of-treatment analysis of Part B in the second half of
2022.
- Phase 1 Part A trial of UB-312 in healthy volunteers results
published in Movement Disorders, April 15, 2022.
UB-313 Phase 1 Clinical Trial Enrollment
Started
- UB-313 targets calcitonin gene-related peptide (CGRP) for the
preventive treatment of migraine.
- Subsequent to the quarter-end, Vaxxinity began enrolling
healthy volunteers into a Phase 1 clinical trial evaluating UB-313
for safety, tolerability, and immunogenicity. The trial also
includes target engagement as a secondary endpoint in the form of
capsaicin-induced dermal blood flow, a well established biomarker.
Vaxxinity expects to report initial data from the Phase 1 study in
1H23.
VXX-401 Preclinical Proof-of-Concept Achieved, Advanced
into IND-Enabling Studies
- VXX-401 targets proprotein convertase subtilisin/kexin type 9
(PCSK9) to lower low-density lipoprotein (LDL) and reduce the risk
of cardiac events.
- Two back-to-back studies in non-human primates demonstrate that
VXX-401 is well tolerated and provides long-lasting, significant
LDL reduction versus placebo.
- Vaxxinity has advanced VXX-401 into IND-enabling studies and
expects to initiate a FIH trial by early 2023.
UB-612 Phase 3 Heterologous Boost Study
Ongoing
- UB-612 employs a unique “multitope” approach to neutralizing
the SARS-CoV-2 virus.
- Awarded CEPI grant for $9.2 million for Ph3 heterologous boost
trial
- The Phase 3 heterologous boost study evaluating UB-612 against
COVID-19 in subjects who have received primary immunization from
mRNA, adenovirus vector, or inactivated viral vaccines is ongoing.
Vaxxinity expects a topline readout in the second half of 2022, and
if successful, these data will support global marketing
authorization applications.
- Data on neutralizing antibodies against SARS=CoV-2 Omicron BA.1
and BA.2 following a booster dose of UB-612 published in The
Journal of Infectious Diseases, June 20, 2022.
Second Quarter 2022 Financial Results
As of June 30, 2022, cash and cash equivalents were
$109.1 million, as compared to $144.9 million on December 31, 2021.
As of June 30, 2022, the Company also has a Restricted Cash balance
of $4.7 million of which $4.6 million is restricted for the
reimbursement of certain research and development expenses related
to our UB-612 Covid vaccine program.
Research and development (R&D) expenses for the three months
ended June 30, 2022 were $10.7 million compared to $19.0 million
for the three months ended June 30, 2021. The $8.3 million decrease
consisted of decreases in program-specific costs of $13.7 million
and increases in non-program costs of $5.3 million. Of the
program-specific decrease, $16.9 million was related to our UB-612
Covid vaccine program, partially offset by increases in spend of
$1.3 million on our UB-313 migraine program and $0.7 million on our
UB-312 Parkinson’s Disease program. The non-program increase was
driven primarily by an increase of $4.2 million in personnel costs
(including $0.6 million of stock-based compensation) as we added
staff to advance our pipeline, and related overhead costs
associated with our Florida lab space.
General and administrative (G&A) expenses for the three
months ended June 30, 2022 were $6.6 million compared to $5.8
million for the three months ended June 30, 2021. The $0.8 million
increase was primarily driven by an increase of $0.9 million in
Directors and Officers (D&O) insurance and $0.7 million of
salaries and personnel costs (including $0.4 million of stock-based
compensation), partially offset by decreases of $1.0 million in
consulting costs and professional services.
Net loss for the three months ended June 30, 2022 was $17.3
million or $0.14 per share compared to $26.9 million or $0.39 per
share for the three months ended June 30, 2021.
About Vaxxinity
Vaxxinity, Inc. is a purpose-driven biotechnology company
committed to democratizing healthcare across the globe. Vaxxinity’s
is pioneering a new class of synthetic, peptide-based
immunotherapeutic vaccines aimed at disrupting the existing
treatment paradigm for chronic disease, increasingly dominated by
monoclonal antibodies, which suffer from prohibitive costs and
cumbersome administration. Vaxxinity’s proprietary technology
platform has enabled the innovation of novel pipeline candidates
designed to bring the efficiency of vaccines to the treatment of
chronic diseases, including Alzheimer’s, Parkinson’s, migraine, and
hypercholesterolemia. The technology is also implemented as part of
a COVID-19 vaccine program. Vaxxinity has optimized its pipeline to
achieve a potentially historic, global impact on human health.
For more information about Vaxxinity, Inc., visit
http://www.vaxxinity.com and follow us on social media
@vaxxinity.
Forward-looking Statement
This press release includes forward-looking statements within
the meaning of the Private Securities Litigation Reform Act of
1995. The use of certain words, including “look forward,” “may,”
“expect,” “potentially,” and “will” and similar expressions, are
intended to identify forward-looking statements. These
forward-looking statements involve substantial risks and
uncertainties, and are based on the current expectations and
assumptions of Vaxxinity’s management. Forward-looking statements
include statements about the development of a new class of
immunotherapeutic vaccines, the innovation and potential efficacy
of Vaxxinity’s product candidates, and the anticipated outcomes
from the studies we are conducting or will conduct for our product
candidates. Various important factors could cause actual results or
events to differ materially from those that may be expressed or
implied by our forward-looking statements. Additional important
factors to be considered in connection with forward-looking
statements are described in the "Risk Factors" section of the
Vaxxinity’s Annual Report on Form 10-K filed with the Securities
and Exchange Commission on March 24, 2022 and other reports we file
with the Securities and Exchange Commission. The forward-looking
statements are made as of this date and Vaxxinity does not
undertake any obligation to update any forward-looking statements,
whether as a result of new information, future events or otherwise,
except as required by law.
|
|
VAXXINITY,
INC. |
Statement of
Operations |
(In
thousands, except number of shares and per share
amounts) |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Three Months
Ended |
|
|
Six Months
Ended |
|
|
|
June 30, |
|
|
June 30, |
|
|
|
2022 |
|
|
2021 |
|
|
2022 |
|
|
2021 |
|
|
|
|
|
|
|
|
|
|
|
|
|
Revenue |
|
$ |
0 |
|
|
$ |
0 |
|
|
$ |
0 |
|
|
$ |
17 |
|
Cost of
revenue |
|
|
0 |
|
|
|
1,927 |
|
|
|
0 |
|
|
|
1,928 |
|
Gross (loss) profit |
|
|
0 |
|
|
|
(1,927 |
) |
|
|
0 |
|
|
|
(1,911 |
) |
Operating
expenses: |
|
|
|
|
|
|
|
|
|
|
|
|
Research and development |
|
|
10,664 |
|
|
|
19,020 |
|
|
|
22,142 |
|
|
|
30,708 |
|
General and administrative |
|
|
6,560 |
|
|
|
5,846 |
|
|
|
13,246 |
|
|
|
14,430 |
|
Total operating expenses |
|
|
17,224 |
|
|
|
24,866 |
|
|
|
35,388 |
|
|
|
45,138 |
|
Loss from
operations |
|
|
(17,224 |
) |
|
|
(26,793 |
) |
|
|
(35,388 |
) |
|
|
(47,049 |
) |
Other
(income) expense: |
|
|
|
|
|
|
|
|
|
|
|
|
Interest expense, net |
|
|
105 |
|
|
|
109 |
|
|
|
210 |
|
|
|
620 |
|
Interest income |
|
|
(75 |
) |
|
|
(2 |
) |
|
|
(80 |
) |
|
|
(2 |
) |
Change in fair value of convertible notes |
|
|
0 |
|
|
|
0 |
|
|
|
0 |
|
|
|
2,667 |
|
Change in fair value of simple agreement for future equity |
|
|
0 |
|
|
|
0 |
|
|
|
0 |
|
|
|
8,365 |
|
Change in fair value of warrant liability |
|
|
0 |
|
|
|
0 |
|
|
|
0 |
|
|
|
214 |
|
Foreign currency loss, net |
|
|
(2 |
) |
|
|
8 |
|
|
|
(3 |
) |
|
|
16 |
|
Other (income) expense |
|
|
28 |
|
|
|
115 |
|
|
|
127 |
|
|
|
11,880 |
|
Loss before
income taxes |
|
|
(17,252 |
) |
|
|
(26,908 |
) |
|
|
(35,515 |
) |
|
|
(58,929 |
) |
Provision
for income taxes |
|
|
0 |
|
|
|
0 |
|
|
|
0 |
|
|
|
0 |
|
Net
loss |
|
$ |
(17,252 |
) |
|
$ |
(26,908 |
) |
|
$ |
(35,515 |
) |
|
$ |
(58,929 |
) |
Net loss per
share, basic and diluted |
|
|
(0.14 |
) |
|
|
(0.39 |
) |
|
|
(0.28 |
) |
|
|
(0.86 |
) |
Weighted
average common shares outstanding, basic and diluted |
|
|
125,948,595 |
|
|
|
68,702,833 |
|
|
|
125,829,764 |
|
|
|
68,627,943 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
VAXXINITY, INC. |
Selected Balance Sheet Data |
(in Thousands) |
|
|
|
|
|
|
|
June 30, |
|
December 31, |
|
2022 |
|
2021 |
Cash and cash equivalents |
$ |
109,066 |
|
$ |
144,885 |
Total assets |
|
136,996 |
|
|
166,673 |
Total liabilities |
|
39,655 |
|
|
38,054 |
Total stockholder's equity (deficit) |
|
97,341 |
|
|
128,619 |
|
|
|
|
|
|
|
|
|
|
|
|
Investor Contact Ben Matone
benm@vaxxinity.com
Press Contact Kate Coyle
media@vaxxinity.com
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