Icosavax Reports Fourth Quarter and Full Year 2021 Financial Results and Provides Corporate Update
March 30 2022 - 3:15PM
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 fourth quarter and full year
ended December 31, 2021 and provided a corporate update.
“Despite the recent readout for IVX-411, I am
pleased with the progress we achieved in 2021, including our
successful initial public offering and advancing two programs into
the clinic,” said Adam Simpson, Chief Executive Officer of
Icosavax. “We continue to progress and evaluate our VLP vaccine
candidates for multiple indications, and in particular look forward
to the 2Q 2022 topline interim data from our lead program, IVX-121
against RSV. RSV represents a significant commercial opportunity,
and the readout provides the company with a near-term potential
milestone that may also serve as clinical proof of concept for our
VLP platform. Contingent on positive data from that trial, we plan
to then initiate a Phase 1 study of our first combination vaccine
candidate, IVX-A12, for RSV and human metapneumovirus during 2H
2022.”
Fourth Quarter 2021 and Subsequent
Highlights
- Announced topline interim
Phase 1/2 data for IVX-411 against SARS-CoV-2. In March,
Icosavax reported topline, interim data for IVX-411, a VLP vaccine
candidate displaying the SARS-CoV-2 receptor-binding domain (RBD).
Immunologic response was observed in both SARS-CoV-2 naive and
previously vaccinated subjects, but at lower than expected levels
that were inconsistent with known data about VLPs, including from
clinical studies in COVID-19 and the company’s own preclinical
data. As a result, the company is conducting an end-to-end drug
product investigation to better understand the results and
determine a path forward for the COVID-19 program.
- Initiated influenza
program. Icosavax licensed the rights to develop and
commercialize an influenza VLP vaccine from the University of
Washington, as the company executes on its strategy to develop
combination VLP vaccines targeting the viral causes of pneumonia in
older adults. The company has initiated preclinical development of
a quadrivalent, VLP influenza vaccine candidate.
- Appointed John Shiver,
Ph.D., to Board of Directors, and Robin Robinson, Ph.D. to
Scientific Advisory Board (SAB). In January, Dr. Shiver
was appointed to Icosavax’s Board of Directors. Dr. Shiver has more
than 30 years of experience in vaccine and pharmaceutical research,
having guided scientific teams to create novel vaccine and
monoclonal antibody candidates to prevent or treat more than 40
infectious and non-infectious diseases. Icosavax also expanded its
SAB with the addition of Dr. Robinson, who previously served for
eight years as the first Director for the Biomedical Advanced
Research and Development Authority (BARDA) and before that was Head
of Vaccines at Novavax, Inc.
- Data published on prefusion
hMPV antigen being advanced as part of IVX-A12, a combination
bivalent RSV and human Metapneumovirus (hMPV) VLP vaccine
candidate. Nature Communications published new data
showing that a prefusion form of the hMPV antigen elicits a
six-fold greater immune response in mice versus the postfusion
form. Icosavax has exclusively licensed rights to this prefusion
stabilized F antigen (except for one mRNA license that may be
granted) and incorporated the stabilizing mutations into a
VLP-based antigen.
Near-Term Milestone
Expectations
- IVX-121 (RSV) Phase 1/1b topline
interim data expected in 2Q 2022
- Provide update on IVX-411 (Covid)
following company’s end-to-end investigation
- IND submission for IVX-A12
(RSV+hMPV) and initiation of a Phase 1 trial for IVX-A12 expected
in 2H 2022
Fourth Quarter and Full Year 2021
Financial Results
- Cash and restricted
cash as of December 31, 2021 was $280.7 million,
compared to $15.5 million for the period ended December 31, 2020.
Icosavax currently expects its cash balance to be sufficient to
fund operations through at least 2024.
- Research and development
(R&D) expenses for the three and twelve months
ended December 31, 2021 were $14.1 million and $38.8, respectively,
compared to $5.2 million and $17.7 for the same period in 2020,
respectively. The increase was primarily driven by increased
clinical development and manufacturing costs, growth in the number
of R&D employees, including increased stock-based compensation
expense, and increased preclinical development and manufacturing
activity. Research and development expenses include non-cash
stock-based compensation expense of $1.2 million and $2.7 million
for the three and twelve months ended December 31, 2021,
respectively.
- General and administrative
(G&A) expenses for the three and twelve months
ended December 31, 2021 were $6.2 million and $34.9, respectively,
compared to $0.8 million and $2.7 for the same period in 2020,
respectively. The increase was primarily due to growth in the
number of G&A employees, including increased stock-based
compensation expense, and increased professional services and other
operating expenses to support the company’s growth. The increased
stock-based compensation for the twelve months ended December 31,
2021 is inclusive of $21.0 million in one-time, non-cash expense
from the acceleration of options in connection with the death of
the company’s former co-founder and Chairman (Tachi Yamada).
General and administrative expenses include non-cash stock-based
compensation expense of $2.4 million and $26.3 million for the
three and twelve months ended December 31, 2021, respectively.
- Net loss for
the three and twelve months ended December 31, 2021 was
$18.2 million and $67.0 million, respectively, or a basic and
diluted net loss per share attributable to common stockholders of
$0.46 and $3.73, respectively. This includes non-cash stock-based
compensation expense of $29.0 million. Net loss for the same period
in 2020 was $4.6 million and $18.9 million, respectively, or a
basic and diluted net loss per share attributable to common
stockholders of $1.28 and $8.40, respectively.
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 is
designed to 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 pipeline includes vaccine candidates targeting
respiratory syncytial virus (RSV), human metapneumovirus (hMPV) and
severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2), and
an emerging program in influenza. 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 therapeutic and commercial potential of, its vaccine
product candidates; the company’s ability to advance its
development program and achieve the noted development milestones in
2022; and the sufficiency of the company’s current cash, cash
equivalents, and investments to fund its operations through at
least 2024. 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 plan to pursue a
combination bivalent RSV/hMPV VLP vaccine candidate, which is a
novel and unproven approach; potential delays in the commencement,
enrollment, and completion of clinical trials and preclinical
studies; the company’s dependence on third parties in connection
with manufacturing, research, and preclinical and clinical testing;
unexpected adverse side effects or inadequate immunogenicity or
efficacy of the company’s product candidates that may limit their
development, regulatory approval, and/or commercialization; the
potential for the end-to-end drug product investigation relating to
IVX-411 to produce inconclusive results; the potential that, even
if the investigation identifies a root cause or contributing
factors for the lower than expected IVX-411 interim topline
immunogenicity data, the company may be unable to resolve all
ambiguity; the potential for the investigation into IVX-411 interim
results to impact the results of the company’s ongoing trial for
IVX-121; the possibility of disappointing results in later clinical
trials despite promising results in earlier preclinical research or
clinical trials; 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 obtain
and maintain intellectual property protection for its product
candidates and maintain its rights under intellectual property
licenses; the company’s ability to fund its operating plans with
its current cash, cash equivalents, and investments; the company’s
ability to maintain undisrupted business operations during the
COVID-19 pandemic, including with respect to clinical trials,
manufacturing, and supply chain; 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 September 30,
2021 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.
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.Balance
Sheets(in thousands)
|
December 31, |
|
|
2021 |
|
|
|
2020 |
|
Assets |
|
|
|
Current assets: |
|
|
|
Cash |
$ |
279,082 |
|
|
$ |
13,114 |
|
Restricted cash |
|
1,642 |
|
|
|
2,384 |
|
Prepaid expenses and other current assets |
|
5,829 |
|
|
|
662 |
|
Total current assets |
|
286,553 |
|
|
|
16,160 |
|
Property and equipment, net |
|
1,076 |
|
|
|
10 |
|
Total assets |
$ |
287,629 |
|
|
$ |
16,170 |
|
Liabilities, convertible preferred stock, and stockholders'
equity (deficit) |
|
|
Current liabilities: |
|
|
|
Accounts payable |
$ |
3,899 |
|
|
$ |
1,918 |
|
Accrued and other current liabilities |
|
4,757 |
|
|
|
1,532 |
|
Deferred revenue |
|
582 |
|
|
|
2,384 |
|
Total current liabilities |
|
9,238 |
|
|
|
5,834 |
|
Long-term convertible promissory note |
|
— |
|
|
|
4,947 |
|
Embedded derivative liability |
|
— |
|
|
|
1,604 |
|
Other noncurrent liabilities |
|
171 |
|
|
|
426 |
|
Total liabilities |
|
9,409 |
|
|
|
12,811 |
|
Convertible preferred stock |
|
— |
|
|
|
30,062 |
|
Stockholders' equity (deficit): |
|
|
|
Preferred stock |
|
— |
|
|
|
— |
|
Common stock |
|
5 |
|
|
|
2 |
|
Additional paid-in capital |
|
372,284 |
|
|
|
393 |
|
Accumulated deficit |
|
(94,069 |
) |
|
|
(27,098 |
) |
Total stockholders' equity (deficit) |
|
278,220 |
|
|
|
(26,703 |
) |
Total liabilities, convertible preferred stock and stockholders'
equity (deficit) |
$ |
287,629 |
|
|
$ |
16,170 |
|
|
|
|
|
ICOSAVAX, INC.Statements
of Operations and Comprehensive Loss(in thousands, except
share and per share data)
|
Three Months Ended December 31, |
|
Year Ended December 31, |
|
|
2021 |
|
|
|
2020 |
|
|
|
2021 |
|
|
|
2020 |
|
|
(unaudited) |
|
|
|
|
Grant revenue |
$ |
2,070 |
|
|
$ |
1,616 |
|
|
$ |
7,802 |
|
|
$ |
1,616 |
|
Operating expenses: |
|
|
|
|
|
|
|
Research and development |
|
14,063 |
|
|
|
5,329 |
|
|
|
38,776 |
|
|
|
17,667 |
|
General and administrative |
|
6,218 |
|
|
|
802 |
|
|
|
34,887 |
|
|
|
2,659 |
|
Total operating expenses |
|
20,281 |
|
|
|
6,131 |
|
|
|
73,663 |
|
|
|
20,326 |
|
Loss from operations |
|
(18,211 |
) |
|
|
(4,515 |
) |
|
|
(65,861 |
) |
|
|
(18,710 |
) |
Other income (expense): |
|
|
|
|
|
|
|
Change in fair value of embedded derivative liability |
|
— |
|
|
|
187 |
|
|
|
(205 |
) |
|
|
187 |
|
Loss on extinguishment of convertible promissory note |
|
— |
|
|
|
— |
|
|
|
(754 |
) |
|
|
— |
|
Interest and other expense |
|
29 |
|
|
|
(280 |
) |
|
|
(151 |
) |
|
|
(331 |
) |
Total other expense |
|
29 |
|
|
|
(93 |
) |
|
|
(1,110 |
) |
|
|
(144 |
) |
Net loss and comprehensive loss |
$ |
(18,182 |
) |
|
$ |
(4,608 |
) |
|
$ |
(66,971 |
) |
|
$ |
(18,854 |
) |
Net loss per share, basic and diluted |
$ |
(0.46 |
) |
|
$ |
(1.28 |
) |
|
$ |
(3.73 |
) |
|
$ |
(8.40 |
) |
Weighted-average common shares outstanding, basic and diluted |
|
39,139,724 |
|
|
|
3,596,936 |
|
|
|
17,965,894 |
|
|
|
2,245,223 |
|
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