Icosavax Reports Third Quarter 2023 Financial Results and Provides Corporate Update
14 Novembro 2023 - 6:05PM
Icosavax, Inc. (Nasdaq: ICVX), a biopharmaceutical company
leveraging its innovative virus-like particle (VLP) platform
technology to develop vaccines against infectious diseases, with an
initial focus on life-threatening respiratory diseases and a vision
of creating pan-respiratory vaccines for older adults, today
reported financial results for the third quarter ended September
30, 2023 and provided a corporate update.
“We are pleased with our clinical data updates
and continued pipeline progress this year. IVX-A12, our potential
first-in-class combination vaccine candidate for RSV and hMPV,
could address a significant unmet need and represent a large market
opportunity for the company,” said Adam Simpson, Chief Executive
Officer of Icosavax. “Our Phase 2 study for IVX-A12 remains on
track to report topline interim results by the end of 2023, and our
Phase 1 six-month durability data in the first quarter of 2024
gives us another opportunity to show a potentially differentiated
profile for our VLP-based technology. In addition, we today
announced candidate selection for our SARS-CoV-2 and influenza
programs. While we are not pursuing further development of these
candidates at this time, they provide strategic optionality for
potential future pan-respiratory vaccines and also highlight our
company’s antigen design capabilities.”
Third Quarter 2023 and Subsequent
Highlights
-
Completed candidate selection milestones for SARS-CoV-2 and
influenza. In SARS-CoV-2, Icosavax has identified a
generalizable RBD design that can improve stability, antigenicity,
and expression levels of RBD antigens from diverse variants,
including the original ancestral strain, BA.1, BA.5, and XBB. When
immunogenicity was tested in the context of the BA.5 strain, the
modified RBD antigen induced robust neutralizing antibody titers in
a mouse model while the native unmodified antigen did not. In
influenza, the company has selected both a QIV hemagglutinin (HA)
candidate demonstrating robust hemagglutination inhibition and
neutralizing antibody titer data against matched strains, and a
neuraminidase (NA) prototype candidate with strain-independent
antigen design blueprints that can be used to produce stable and
immunogenic NA antigens from all current seasonal subtypes and
lineages. Preclinical data show that when the company combines a
designed NA antigen with a quadrivalent HA VLP, robust titers are
generated against both HA and NA from the same vaccine. Icosavax
has now achieved its near-term objective for these two
programs.
-
Presenting the company’s antigen design capability at
upcoming World Vaccine & Immunotherapy Congress West
Coast. Icosavax will be presenting on November 29, 2023,
at 12:50 pm PT in a talk entitled, “From computationally designed
antigens to VLP-based antigen display – a recipe for best-in-class
vaccines.” The presentation will be made by Dr. Daniel Ellis,
Senior Scientist Computational Discovery, Icosavax.
-
Reported positive 12-month durability data for IVX-121
against RSV and initial evidence for revaccination
potential. In August 2023, Icosavax provided an update
from its Phase 1b extension trial of IVX-121 against RSV in older
adults. These data demonstrate substantial durability of
neutralizing antibody (NAb) response against RSV at twelve months
after a single administration of IVX-121, and initial evidence for
revaccination potential with its VLP-based vaccines, including
robust immune responses against RSV-A in participants who received
75 µg unadjuvanted IVX-121 at one year after their first dose.
-
Appointed Dr. Antu Dey as Senior Vice President,
Preclinical Research and Development. Icosavax recently
appointed Antu Dey, PhD as the company’s Senior Vice President of
Preclinical R&D. He has more than 15 years of industry
experience in discovery and early development of novel vaccine and
biologic candidates against multiple infectious disease targets.
Prior to Icosavax, Antu held roles of increasing responsibility at
GreenLight Biosciences, International Aids Vaccines Initiative
(IAVI), Novartis Vaccines & Diagnostics, and GSK Vaccines.
Near-Term Milestone
Expectations
- IVX-A12
(RSV + hMPV) Phase 2 topline interim data expected by end of
2023
- IVX-A12
(RSV+ hMPV) Phase 1 six-month immunogenicity data expected in 1Q
2024
Third Quarter Financial
Results
- Cash and
cash equivalents and short-term investments as of
September 30, 2023 was $229.2 million, compared to $219.4 million
for the period ended December 31, 2022. Icosavax currently expects
its cash balance to be sufficient to fund operations into 2H
2025.
- Research
and development (R&D) expenses for the three
months ended September 30, 2023 were $16.7 million, compared to
$15.5 million for the same period in 2022. The increase was
primarily driven by increased personnel related expenses and
stock-based compensation expense. Research and development expenses
include non-cash stock-based compensation expenses of $2.7 million
for the three months ended September 30, 2023.
- General
and administrative (G&A) expenses for the three
months ended September 30, 2023 were $8.6 million compared to $7.7
million for the same period in 2022. The increase was primarily due
to increased stock-based compensation expense and growth in the
number of G&A employees. General and administrative expenses
include non-cash stock-based compensation expenses of $3.9 million
for the three months ended September 30, 2023.
- Net
loss for the three months ended September
30, 2023 was $22.0 million, or a basic and diluted net
loss per share of $0.44. This includes non-cash stock-based
compensation expense of $6.6 million. Net loss for the same period
in 2022 was $22.0 million or a basic and diluted net loss per share
of $0.55.
About Icosavax
Icosavax is a biopharmaceutical company
leveraging its innovative VLP platform technology to develop
vaccines against infectious diseases, with an initial focus on
life-threatening respiratory diseases and a vision for combination
and pan-respiratory vaccines. Icosavax’s VLP platform technology
and antigen design capabilities enable multivalent, particle-based
display of complex viral antigens, which it believes will induce
broad, robust, and durable protection against the specific viruses
targeted. Icosavax’s lead program is a combination vaccine
candidate targeting respiratory syncytial virus (RSV) and human
metapneumovirus (hMPV). Its pipeline includes additional candidates
that provide optionality as potential components of future
combination and pan-respiratory vaccines, including influenza and
SARS-CoV-2, and the company may also develop candidates in other
areas of unmet need where VLP vaccines have the potential to offer
differentiated benefits. Icosavax was formed in 2017 to advance the
breakthrough VLP technology from the Institute for Protein Design
at the University of Washington with the goal to discover, develop,
and commercialize vaccines against infectious diseases. Icosavax is
located in Seattle.
For more information, visit
www.icosavax.com.
Forward-Looking Statements
Statements contained in this press release
regarding matters that are not historical facts are forward-looking
statements. The forward-looking statements are based on the
company’s current beliefs and expectations and include, but are not
limited to: the company’s expectation regarding the opportunities
for, and the prophylactic and commercial potential of, its vaccine
candidates and technology platform, including the potential for
IVX-A12 to be a first-in-class vaccine; the company’s ability to
advance its development program and achieve the noted development
milestones in 2023 and 2024; and the sufficiency of the company’s
current cash, cash equivalents and investments to fund its
operations into 2H 2025. Actual results may differ from those set
forth in this press release due to the risks and uncertainties
inherent in the company’s business, including, without limitation:
the early stage of the company’s development efforts; the company’s
approach to the development of vaccine candidates, including its
development of a combination bivalent RSV/hMPV VLP vaccine
candidate, which is a novel and unproven approach; potential delays
in the development process including without limitation in the
commencement, enrollment, conduct of, and receipt of data from,
clinical trials; unexpected adverse side effects or inadequate
immunogenicity or efficacy of the company’s vaccine candidates that
may limit their development, regulatory approval, and/or
commercialization; the company’s dependence on third parties in
connection with manufacturing, research, and clinical testing; the
risk that approved third party RSV vaccines may make conducting
clinical trials more difficult and costly and otherwise adversely
affect the company’s ability to successfully develop, obtain
regulatory approval of and commercialize its vaccine candidates;
approved vaccines and competing approaches limiting the commercial
value of the company’s vaccine candidates; regulatory developments
in the United States and other countries; the company’s ability to
fund its operating plans with its current cash, cash equivalents
and investments; and other risks described in the company’s prior
filings with the Securities and Exchange Commission (SEC),
including under the heading “Risk Factors” in the company’s
quarterly report on Form 10-Q for the quarter ended June 30, 2023
and any subsequent filings with the SEC. You are cautioned not to
place undue reliance on these forward-looking statements, which
speak only as of the date hereof, and the company undertakes no
obligation to update such statements to reflect events that occur
or circumstances that exist after the date hereof. All
forward-looking statements are qualified in their entirety by this
cautionary statement, which is made under the safe harbor
provisions of the Private Securities Litigation Reform Act of
1995.
Icosavax’s Contacts
Media Contact:Jessica Yingling, Ph.D.,Little Dog Communications
Inc.jessica@litldog.com858.344.8091
Investor Contact:Laurence WattsGilmartin Group,
LLClaurence@gilmartinir.com619.916.7620
|
|
ICOSAVAX, INC. |
|
Condensed Balance Sheets |
|
(Unaudited) |
|
(in thousands) |
|
|
September 30, |
|
December 31, |
|
|
2023 |
|
|
|
2022 |
|
Assets |
|
|
|
Current assets: |
|
|
|
Cash and cash equivalents |
$ |
63,239 |
|
|
$ |
58,846 |
|
Restricted cash |
|
— |
|
|
|
1,061 |
|
Short-term investments |
|
165,967 |
|
|
|
159,461 |
|
Prepaid expenses and other current assets |
|
6,101 |
|
|
|
4,545 |
|
Total current assets |
|
235,307 |
|
|
|
223,913 |
|
Right-of-use assets – operating leases |
|
2,975 |
|
|
|
3,247 |
|
Property and equipment, net |
|
11,400 |
|
|
|
11,517 |
|
Other noncurrent assets |
|
1,614 |
|
|
|
— |
|
Total assets |
$ |
251,296 |
|
|
$ |
238,677 |
|
Liabilities and stockholders' equity |
|
|
|
Current liabilities: |
|
|
|
Accounts payable |
$ |
1,239 |
|
|
$ |
2,892 |
|
Accrued and other current liabilities |
|
9,606 |
|
|
|
8,759 |
|
Current portion of operating lease liabilities |
|
2,185 |
|
|
|
2,137 |
|
Total current liabilities |
|
13,030 |
|
|
|
13,788 |
|
Operating lease liabilities, net of current portion |
|
5,886 |
|
|
|
6,658 |
|
Other noncurrent liabilities |
|
— |
|
|
|
69 |
|
Total liabilities |
|
18,916 |
|
|
|
20,515 |
|
Stockholders' equity: |
|
|
|
Common stock |
|
7 |
|
|
|
6 |
|
Additional paid-in capital |
|
491,347 |
|
|
|
404,386 |
|
Accumulated other comprehensive loss |
|
(48 |
) |
|
|
(403 |
) |
Accumulated deficit |
|
(258,926 |
) |
|
|
(185,827 |
) |
Total stockholders' equity |
|
232,380 |
|
|
|
218,162 |
|
Total liabilities and stockholders' equity |
$ |
251,296 |
|
|
$ |
238,677 |
|
|
|
|
|
ICOSAVAX, INC. |
|
Condensed Statements of Operations and Comprehensive
Loss |
|
(Unaudited) |
|
(in thousands, except share and per share data) |
|
|
|
|
|
|
|
|
|
Three Months Ended September 30, |
|
Nine Months Ended September 30, |
|
|
2023 |
|
|
|
2022 |
|
|
|
2023 |
|
|
|
2022 |
|
|
|
|
|
Grant revenue |
$ |
— |
|
|
$ |
— |
|
|
$ |
— |
|
|
$ |
582 |
|
Operating expenses: |
|
|
|
|
|
|
|
Research and development |
|
16,668 |
|
|
|
15,484 |
|
|
|
53,851 |
|
|
|
49,217 |
|
General and administrative |
|
8,607 |
|
|
|
7,659 |
|
|
|
26,901 |
|
|
|
21,292 |
|
Total operating expenses |
|
25,275 |
|
|
|
23,143 |
|
|
|
80,752 |
|
|
|
70,509 |
|
Loss from operations |
|
(25,275 |
) |
|
|
(23,143 |
) |
|
|
(80,752 |
) |
|
|
(69,927 |
) |
Other income: |
|
|
|
|
|
|
|
Interest and other income |
|
3,234 |
|
|
|
1,167 |
|
|
|
7,653 |
|
|
|
1,782 |
|
Total other income |
|
3,234 |
|
|
|
1,167 |
|
|
|
7,653 |
|
|
|
1,782 |
|
Net loss |
$ |
(22,041 |
) |
|
$ |
(21,976 |
) |
|
$ |
(73,099 |
) |
|
$ |
(68,145 |
) |
Other comprehensive income (loss): |
|
|
|
|
|
|
|
Unrealized gains (losses) on available-for-sale debt
securities |
|
18 |
|
|
|
(334 |
) |
|
|
355 |
|
|
|
(609 |
) |
Comprehensive loss |
$ |
(22,023 |
) |
|
$ |
(22,310 |
) |
|
$ |
(72,744 |
) |
|
$ |
(68,754 |
) |
Net loss per share, basic and diluted |
$ |
(0.44 |
) |
|
$ |
(0.55 |
) |
|
$ |
(1.61 |
) |
|
$ |
(1.72 |
) |
Weighted-average common shares outstanding, basic and diluted |
|
50,030,759 |
|
|
|
39,748,984 |
|
|
|
45,411,654 |
|
|
|
39,623,357 |
|
|
|
|
|
|
|
|
|
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