Vaxxinity Reports First Quarter 2022 Financial Results and Provides Corporate Updates
May 09 2022 - 7:42AM
Vaxxinity, Inc. (Nasdaq: VAXX), a U.S. company pioneering the
development of a new class of immunotherapeutic vaccines, today
reported financial results for the first quarter ended March 31,
2022.
“Vaxxinity has laid the groundwork to have multiple shots on
goal this year after a productive and exciting start to 2022. The
FDA granted Fast Track designation to our Alzheimer’s vaccine
candidate and we completed enrollment for our Parkinson’s vaccine
candidate with initial data expected in the second half of this
year. We also initiated enrollment in our global pivotal Phase 3
trial of UB-612 for prevention of COVID-19 with the support of a
CEPI grant,” said Mei Mei Hu, CEO of Vaxxinity. “As we pursue our
mission to democratize health and bring transformative medicines to
all patients in need, we look forward to initiating our
first-in-human trial of our migraine vaccine candidate and
reporting proof-of-concept data in non-human primates for our LDL
cholesterol-lowering vaccine.”
First Quarter 2022 and Recent Updates
UB-311 receives FDA Fast Track Designation for
Alzheimer’s Disease
- FDA’s determination that UB-311
could potentially address a serious unmet medical need was based on
both preclinical data and clinical data in Alzheimer’s
patients
- This designation will facilitate the
development and expedite the review of UB-311
UB-312 targets toxic forms of aggregated α-synuclein in
the brain to fight Parkinson’s disease (PD) and other
synucleinopathies.
- As of April 2022, the Part B arm of
the ongoing, double-blinded, placebo-controlled Phase 1 trial of
UB-312 in Parkinson’s disease has fully enrolled. The Company
expects to complete an end-of-treatment analysis of Part B in the
second half of 2022.
- The results from Part A of the Phase
1 trial in healthy volunteers were published in Movement Disorders
in April 2022.
UB-612 employs a unique “multitope” approach to
neutralizing the ancestral SARS-CoV-2 virus and its
variants.
- In March 2022, we began dosing
patients in our Phase 3 heterologous boost study of UB-612 designed
to demonstrate the potential for UB-612 to boost immunity against
COVID-19 in subjects who have received primary immunization from
mRNA, adenovirus vector, or inactivated viral vaccines. This
head-to-head trial is designed to demonstrate noninferior
neutralizing antibody titers, comparing UB-612 to each of the three
individual respective platform vaccines. The Company expects a
topline readout in the second half of 2022, and if successful,
these data will support global marketing authorization
applications.
- In April 2022, we announced the
co-funding of the Phase 3 heterologous boost study with the
Coalition for Epidemic Preparedness Innovations (CEPI), providing
up to $9.25m in funding.
First Quarter 2022 Financial Results
As of March 31, 2022, cash and cash equivalents
were $124.8 million, as compared to $144.9 million on December 31,
2021.
Research and development (R&D) expenses for the three months
ended March 31, 2022 were $11.5 million compared to $11.7 million
for the three months ended March 31, 2021. A decrease of $6.0
million related to our UB-612 COVID vaccine program was partially
offset by a $2.4 million increase in program-specific spend in our
other chronic disease programs, including our Parkinson’s,
migraine, and hypercholesterolemia programs, and a non-program
increase of $3.1 million in personnel costs (including stock-based
compensation) as we added team members to advance our pipeline.
General and administrative (G&A) expenses for the three
months ended March 31, 2022 were $6.7 million compared to $8.6
million for the three months ended March 31, 2021. The $1.9 million
decrease was primarily due to decreases in professional services
and other expenses of $1.2 million related to our March 2021
Reorganization, and decreases of $2.0 million in stock-based
compensation and recruiting expenses, partially offset by increased
audit, compliance and insurance costs of $1.3M related to being a
public company.
Net loss for the three months ended March 31, 2022 was $18.3
million or $0.15 per share compared to $32.0 million or $0.47 per
share for the three months ended March 31, 2021.
About Vaxxinity
Vaxxinity, Inc. is a purpose-driven biotechnology company
committed to democratizing healthcare across the globe. The company
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. The company’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 “expect,” “potential,”
"may," “continue,” “looking forward,” and "will" and similar
expressions, are intended to identify forward-looking statements.
These forward-looking statements involve substantial risks and
uncertainties, including statements that are based on the current
expectations and assumptions of Vaxxinity’s management about the
development of a new class of immunotherapeutic vaccines and the
innovation and efficacy of Vaxxinity’s 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, as highlighted in the “Special Note
Regarding Forward-Looking Statements” and "Management’s Discussion
and Analysis of Financial Condition and Results of Operations"
sections of Vaxxinity’s Quarterly Report on Form 10-Q filed with
the Securities and Exchange Commission (SEC) on May 9, 2022 and
described in further detail under the “Risk Factors” section of
Vaxxinity’s Annual Report on Form 10-K filed with the SEC on March
24, 2022. 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) |
|
|
|
|
|
|
|
|
Three Months Ended |
|
|
March 31, |
|
|
2021 |
|
|
|
2022 |
|
|
|
|
|
|
|
Revenue |
$ |
17 |
|
|
$ |
0 |
|
Cost of revenue |
|
1 |
|
|
|
0 |
|
Gross (loss) profit |
|
16 |
|
|
|
0 |
|
Operating expenses: |
|
|
|
|
|
Research and development |
|
11,688 |
|
|
|
11,478 |
|
General and administrative |
|
8,584 |
|
|
|
6,686 |
|
Total operating expenses |
|
20,272 |
|
|
|
18,164 |
|
Loss from operations |
|
(20,256 |
) |
|
|
(18,164 |
) |
Other (income) expense: |
|
|
|
|
|
Interest expense, net |
|
511 |
|
|
|
100 |
|
Change in fair value of convertible notes |
|
2,667 |
|
|
|
0 |
|
Change in fair value of simple agreement for future equity |
|
8,365 |
|
|
|
0 |
|
Change in fair value of warrant liability |
|
214 |
|
|
|
0 |
|
Foreign currency loss, net |
|
8 |
|
|
|
(1 |
) |
Other (income) expense |
|
11,765 |
|
|
|
99 |
|
Loss before income taxes |
|
(32,021 |
) |
|
|
(18,263 |
) |
Provision for income
taxes |
|
0 |
|
|
|
0 |
|
Net loss |
$ |
(32,021 |
) |
|
$ |
(18,263 |
) |
Net loss per share, basic and
diluted |
|
(0.47 |
) |
|
|
(0.15 |
) |
Weighted average common shares
outstanding, basic and diluted |
|
68,550,993 |
|
|
|
125,709,613 |
|
|
|
|
|
|
|
VAXXINITY, INC. |
Selected Balance Sheet Data |
(in Thousands) |
|
|
|
|
|
|
|
December 31, |
|
March 31 |
|
2021 |
|
2022 |
Cash and
cash equivalents |
$ |
144,885 |
|
$ |
124,766 |
Total
assets |
|
166,673 |
|
|
147,528 |
Total
liabilities |
|
38,054 |
|
|
34,873 |
Total
stockholder's equity (deficit) |
|
128,619 |
|
|
112,655 |
|
|
|
|
|
|
Investor ContactClaudia Styslinger
vaxxinity@argotpartners.com
Press ContactPhilip
Cowdellmedia@vaxxinity.com
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