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,
2023 and provided a corporate update.
“Vaxxinity remains on track to meet critical milestones in 2023,
having taken our fifth program to the clinic with VXX-401, our
investigational anti-PCSK9 vaccine for lowering cholesterol. This
represents another opportunity to demonstrate the clinical
potential of our Vaxxine platform,” said Mei Mei Hu, Chief
Executive Officer of Vaxxinity. “Our well-capitalized position
allows us to pursue multiple catalysts across our chronic disease
pipeline, including Phase 1 trial data readouts for our
investigational vaccines including UB-313 for migraine and UB-312
for Parkinson’s disease. We’re also seeking authorization of
UB-612, our investigational COVID-19 booster vaccine, in the UK and
Australia, which may enable its commercialization in multiple
countries including low- and middle-income countries.”
Hu continued, “In the first quarter, Vaxxinity welcomed four new
members to our Board of Directors, strengthening our experience and
ability to set and execute upon our vision at the highest level. We
also established the Frontier Exploration Laboratory in Cape
Canaveral as our new corporate headquarters. Located in one of the
foremost innovation hubs, we are proud to be at our new home as we
continue advancing a new class of medicines in order to democratize
health.”
Vaxxinity corporate headquarters in Cape Canaveral, Fla. (Photo:
Vaxxinity)
First Quarter 2023 and Recent Updates
UB-312 in Parkinson’s disease (PD) and other
synucleinopathies
- UB-312 targets toxic forms of
aggregated α-synuclein in the brain.
- Vaxxinity has completed dosing
patients with PD in Part B of the Phase 1 trial of UB-312, and
anticipates a data readout this summer.
UB-313 in migraine
- UB-313 targets calcitonin
gene-related peptide (CGRP) to prevent migraines.
- In April 2023, JC Dodart, Senior
Vice President of Research, reported UB-313 preclinical data at the
American Academy of Neurology Annual Meeting in Boston in an oral
presentation and a poster titled “UB-313, an Investigational CGRP
Vaccine for the Prevention of Migraine.”
- Vaxxinity anticipates a data readout
in this second quarter of 2023 that will include safety and
tolerability, immunogenicity, and a capsaicin-induced dermal blood
flow model.
VXX-401 in hypercholesterolemia
- VXX-401 targets proprotein
convertase subtilisin/kexin type 9 (PCSK9) to reduce low-density
lipoprotein (LDL) cholesterol.
- In March 2023, the company began
dosing subjects with elevated cholesterol in a first-in-human Phase
1 clinical trial of VXX-401 in Australia.
- The company anticipates topline
Phase 1 data by early 2024.
UB-612 COVID-19 booster
- UB-612 employs a “multitope”
approach to neutralizing the ancestral SARS-CoV-2 virus and its
variants.
- Vaxxinity is pursuing
conditional/provisional marketing authorization of UB-612 with
regulatory authorities in the UK and Australia, who are reviewing
the application under their established work share agreement. If
successful, this submission may enable the commercialization of
UB-612 in multiple countries including low- and middle-income
countries.
- In April 2023, Vaxxinity delivered
two presentations about UB-612 to the World Vaccine Congress in
Washington, D.C.:
- “Vaccine Supply and Access: Lessons
Learned and the Way Forward (a Fireside Chat with Sarah Despres)”
featuring Vaxxinity CEO Mei Mei Hu
- “Success in Boosting the Immunity by
Vaxxinity’s UB-612 Compared to the mRNA, Adenovirus and Inactivated
COVID-19 Vaccine Platforms” featuring Alexander Rumyantsev, M.D.,
Ph.D., Therapeutic Area Head for Infectious Diseases at
Vaxxinity
- Vaxxinity expects to complete the
Phase 3 trial of UB-612 in the second half of 2023 and to obtain
additional data about UB-612’s safety, tolerability, and antibody
titer half-life.
First Quarter 2023 Financial Results
As of March 31, 2023, Vaxxinity had $67.7
million of highly liquid assets, including $22.6 million of cash
and cash equivalents, $45.0 million of short-term investments, and
$0.1 million of restricted cash, compared to $87.9 million as of
December 31, 2022.
Comparison of three months ended March 31, 2023
to three months ended March 31, 2022
Research and development expenses were $11.4
million and $11.5 million for the three months ended March 31,
2023 and 2022, respectively.
Research and development expenses remained
substantially flat across the two quarters due to increases in our
VXX-401 hypercholesterolemia program, platform development and
activities supporting multiple programs totaling $1.2 million,
partially offset by decreases in costs related to our UB-612
COVID-19 vaccine program, UB-312 PD program and UB-313 migraine
program totaling $1.1 million.
General and administrative expenses were $7.4
million and $6.7 million for the three months ended March 31,
2023 and 2022, respectively.
The $0.7 million increase was primarily due to
increases in professional and consulting services, travel expenses,
and salaries and personnel costs, partially offset by a decrease in
director and officer insurance expense of $0.4 million.
Net loss for the three months ended March 31, 2023 was $18.4
million or $0.15 per share compared to $18.3 million or $0.15 per
share for the three months ended March 31, 2022.
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 Statements
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 "believe," "may,"
"continue," "advancing," "will" and similar expressions, are
intended to identify forward-looking statements. Forward-looking
statements include statements, other than statements of historical
fact, regarding, among other things: the plans for, or progress,
scope, initiation, duration, enrollment, results or timing for
availability of results of, development of any of Vaxxinity’s
product candidates or programs, including timing of the data
readouts of UB-313 and VXX-401, and completion of the Phase 3 trial
of UB-612; the target indication(s) for development or approval,
the size, design, population, location, conduct, cost, objective,
enrollment, duration or endpoints of any clinical trial, or the
timing for initiation or completion of or availability or reporting
of results from any clinical trial; the potential future regulatory
authorization or approval and commercialization of Vaxxinity’s
product candidates; the potential benefits or competitive position
of any Vaxxinity product candidate or program or the commercial
opportunity in any target indication; and Vaxxinity’s plans,
expectations or future operations, financial position, revenues,
costs or expenses. 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,
including, but not limited to: whether UB-312, UB-313, VXX-401,
UB-612 or any other current or future product candidate of
Vaxxinity will be approved or authorized by any regulatory agency
for the indications that Vaxxinity targets; any potential negative
impacts of the COVID-19 pandemic, including on manufacturing,
supply, conduct or initiation of clinical trials, or other aspects
of Vaxxinity’s business; Vaxxinity’s product candidates may not be
successful or clinical development may take longer and be more
costly than anticipated; product candidates that appeared promising
in earlier research and clinical trials may not demonstrate safety
or efficacy in larger-scale or later clinical trials or in clinical
trials for other indications; the timing for initiation or
completion of, or for availability of data from, clinical trials
for UB-312, UB-313, VXX-401 or UB-612, and the outcomes of such
trials; Vaxxinity’s reliance on collaborative partners and other
third parties for development of its product candidates;
Vaxxinity’s ability to obtain coverage, pricing or reimbursement
for any approved products and acceptance from patients and
physicians for any approved indications; delays or other challenges
in the recruitment of patients for, or the conduct of, Vaxxinity’s
clinical trials; challenges associated with supply and
manufacturing activities; and Vaxxinity’s accounting policies.
These and other important factors to be considered in connection
with forward-looking statements are described in the "Risk Factors"
section of Vaxxinity’s Annual Report on Form 10-K filed with the
U.S. Securities and Exchange Commission on March 27, 2023. 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 |
|
|
|
March 31, |
|
|
|
2023 |
|
|
|
2022 |
|
|
|
|
|
|
|
|
|
Operating expenses: |
|
|
|
|
|
|
Research and development |
$ |
11,424 |
|
|
$ |
11,478 |
|
|
General and administrative |
|
7,384 |
|
|
|
6,686 |
|
|
Total operating expenses |
|
18,808 |
|
|
|
18,164 |
|
|
Loss from operations |
|
(18,808 |
) |
|
|
(18,164 |
) |
|
Other (income) expense: |
|
|
|
|
|
|
Interest and other expense |
|
192 |
|
|
|
105 |
|
|
Interest and other income |
|
(567 |
) |
|
|
(5 |
) |
|
(Gain) loss on foreign currency transactions, net |
|
(12 |
) |
|
|
(1 |
) |
|
Total other (income) expense, net |
|
(387 |
) |
|
|
99 |
|
|
Net loss |
$ |
(18,421 |
) |
|
$ |
(18,263 |
) |
|
Net loss per share, basic and diluted |
$ |
(0.15 |
) |
|
$ |
(0.15 |
) |
|
Weighted average common shares outstanding, basic and diluted |
|
126,061,273 |
|
|
|
125,709,613 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
VAXXINITY, INC. |
Selected Balance Sheet Data |
(in Thousands) |
|
|
|
|
|
|
|
|
|
|
|
March 31, |
|
|
|
December 31, |
|
|
|
|
2023 |
|
|
|
2022 |
|
|
Cash and cash equivalents |
$ |
22,585 |
|
|
$ |
33,475 |
|
|
Short term investments |
|
44,993 |
|
|
|
53,352 |
|
|
Restricted cash |
|
100 |
|
|
|
1,095 |
|
|
Total assets |
|
85,531 |
|
|
|
106,399 |
|
|
Total liabilities |
|
39,398 |
|
|
|
44,222 |
|
|
Total stockholder's equity (deficit) |
|
46,133 |
|
|
|
62,177 |
|
|
|
|
|
|
|
|
|
|
|
Investor ContactMark
Joinnidesir@vaxxinity.com
Press ContactJon Yumedia@vaxxinity.com
A photo accompanying this announcement is available at
https://www.globenewswire.com/NewsRoom/AttachmentNg/58d93f54-ab1a-4766-a25a-877945d0c543
Vaxxinity (NASDAQ:VAXX)
Gráfico Histórico do Ativo
De Mai 2024 até Jun 2024
Vaxxinity (NASDAQ:VAXX)
Gráfico Histórico do Ativo
De Jun 2023 até Jun 2024