Icosavax Reports Third Quarter 2021 Financial Results and Provides Corporate Update
November 15 2021 - 04:05PM
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, today
reported financial results for the third quarter ended September
30, 2021 and provided a corporate update.
“I am pleased with the progress that Icosavax
has made in the third quarter, highlighted by our successful IPO in
July, the initiation of a Phase 1/1b clinical trial for IVX-121 in
September, and the continued progression of a Phase 1/2 clinical
trial for IVX-411,” said Adam Simpson, Chief Executive Officer of
Icosavax. “As we near the end of the year and look ahead to 2022,
we have several anticipated clinical milestones in the next few
quarters including interim, top-line data readouts from both our
IVX-411 Phase 1/2 and IVX-121 Phase 1/1b clinical trials. I look
forward to providing updates on our clinical programs in the coming
months.”
Third Quarter 2021 and Subsequent
Highlights
- Initiated a Phase 1/1b
clinical trial of IVX-121. In September, Icosavax
initiated a Phase 1/1b clinical trial to assess the safety and
immunogenicity of IVX-121, the company’s VLP vaccine candidate
displaying the prefusion stabilized RSV F antigen, in healthy
adults (Phase 1), including older adults (Phase 1b). Assuming
favorable results from the IVX-121 Phase 1/1b clinical trial and
favorable preclinical data from its human Metapneumovirus (hMPV)
VLP vaccine candidate, Icosavax plans to thereafter initiate a
Phase 1 clinical trial of its IVX-A12 combination bivalent RSV and
hMPV vaccine candidate.
- Progressed a Phase 1/2
clinical trial of IVX-411. Icosavax progressed its Phase
1/2 clinical trial to assess the safety and immunogenicity of
IVX-411, the company’s VLP vaccine candidate displaying the
SARS-CoV-2 receptor-binding domain antigen. Part 1 of this trial is
in adults who have neither had COVID-19 nor been vaccinated with a
licensed COVID-19 vaccine, and Part 2 of this trial is in adults
who have previously completed a vaccine regimen using a licensed
COVID-19 vaccine. Both parts of this trial have completed
dosing.
- Completed successful IPO;
listed on Nasdaq. In July, Icosavax successfully closed
its initial public offering raising gross proceeds of $209.3
million prior to deducting underwriting fees, commissions and
offering expenses. Icosavax’s common stock began trading on the
Nasdaq Global Select Market under the ticker symbol “ICVX” on July
29, 2021.
- Made key appointments to
Executive Team and Board. In July, Ann Veneman was
appointed to Icosavax’s Board of Directors. In August, Mark McDade
was appointed to chair the Board. In September, Icosavax appointed
Elizabeth Bekiroglu as the company’s General Counsel.
Near-Term Milestone
Expectations
- Phase 1/2 interim, top-line data
for IVX-411 in 1H 2022
- Phase 1/1b interim, top-line data
for IVX-121 in 1H 2022
- IND submission for IVX-A12, a
combination bivalent RSV and hMPV VLP vaccine candidate, in 1H
2022
Third Quarter 2021 Financial
Results
- Cash, cash equivalents and
short-term investments as of September 30, 2021 were
$293.9 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 months ended
September 30, 2021 were $10.9 million, compared to $4.8 million for
the same period in 2020. The increase was primarily driven by
increased clinical development and manufacturing costs, increased
stock-based compensation expense, growth in the number of R&D
employees, and increased non-clinical development and manufacturing
activity. Research and development expenses include non-cash
stock-based compensation expense of $0.9 million for the three
months ended September 30, 2021, versus an immaterial amount for
the prior year period.
- General and administrative
(G&A) expenses for the three months ended
September 30, 2021 were $25.4 million, compared to $0.7 million for
the same period in 2020. The increase was primarily due to
increased stock-based compensation expense, increased professional
services and other operating expenses to support the company’s
growth, and growth in the number of G&A employees. General and
administrative expenses include non-cash stock-based compensation
expenses of $22.7 million for the three months ended September 30,
2021, versus an immaterial amount for the prior year period. This
is inclusive of $21.0 million in one-time, non-cash stock-based
compensation expense from the acceleration of options in connection
with the death of the company’s former co-founder and Chairman
(Tachi Yamada).
- Net loss for
the three months ended September 30, 2021 was $34.4
million, or a basic and diluted net loss per share attributable to
common stockholders of $1.30. This includes non-cash stock-based
compensation expense of $23.7 million. Net loss for the same period
in 2020 was $5.6 million, or basic and diluted net loss per share
attributable to common stockholders of $2.40.
About Icosavax’s Virus-Like Particle
(VLP) Vaccines
VLPs enable multivalent display of antigens in a
manner that closely resembles viruses but contain no genetic
material. Approved vaccines that are derived from naturally
occurring VLPs have shown efficacy when formulated as combination
vaccines and have shown the ability to induce high and sustained
levels (titers) of neutralizing antibodies (nAbs) in adults, which
have generally been associated with protective immunity. However,
VLPs engineered to display complex viral antigens have in general
been difficult to develop or successfully manufacture at scale,
limiting the pathogens that can be addressed by this approach.
Icosavax’s VLP vaccine technology is designed to enable robust,
durable and broad immune responses against a broader array of
pathogens than has been possible with naturally occurring VLPs and
to overcome the manufacturing challenges experienced with other VLP
technologies.
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. 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). 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 exclusively licensed the VLP
technology for use in several fields, including RSV and hMPV, from
the University of Washington. For
SARS-CoV-2, Icosavax has a non-exclusive, worldwide
(excluding South Korea) license from the University of Washington
that will convert to an exclusive license in North America and
Europe in 2025. Icosavax is located in Seattle.
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 efficacy of the
company’s product candidates that may limit their development,
regulatory approval, and/or commercialization; results from
preclinical studies or early clinical trials not necessarily being
predictive of future results; 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 June 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.
Condensed Balance Sheets
(Unaudited)(in thousands, except share and par value data)
|
|
September 30, |
|
|
December 31, |
|
|
|
|
2021 |
|
|
2020 |
|
Assets |
|
|
|
|
|
Current
assets: |
|
|
|
|
|
Cash |
|
$ |
291,271 |
|
|
$ |
13,114 |
|
Restricted cash |
|
|
2,652 |
|
|
|
2,384 |
|
Prepaid expenses and other current assets |
|
|
6,353 |
|
|
|
662 |
|
Total current
assets |
|
|
300,276 |
|
|
|
16,160 |
|
Property and
equipment, net |
|
|
548 |
|
|
|
10 |
|
Total assets |
|
$ |
300,824 |
|
|
$ |
16,170 |
|
Liabilities, convertible preferred stock, and stockholders'
equity (deficit) |
|
|
|
|
|
Current
liabilities: |
|
|
|
|
|
Accounts payable |
|
$ |
3,049 |
|
|
$ |
1,918 |
|
Accrued and other current liabilities |
|
|
2,487 |
|
|
|
1,532 |
|
Deferred revenue |
|
|
2,652 |
|
|
|
2,384 |
|
Total current
liabilities |
|
|
8,188 |
|
|
|
5,834 |
|
Long-term convertible promissory note |
|
|
— |
|
|
|
4,947 |
|
Embedded derivative liability |
|
|
— |
|
|
|
1,604 |
|
Other noncurrent liabilities |
|
|
197 |
|
|
|
426 |
|
Total
liabilities |
|
|
8,385 |
|
|
|
12,811 |
|
Convertible
preferred stock |
|
— |
|
|
30,062 |
|
Total
stockholders' equity (deficit) |
|
292,439 |
|
|
(26,703 |
) |
Total liabilities,
convertible preferred stock and stockholders' equity (deficit) |
|
$ |
300,824 |
|
|
$ |
16,170 |
|
|
|
|
|
|
|
|
|
|
ICOSAVAX, INC.
Condensed Statements of Operations and
Comprehensive Loss (Unaudited) (in thousands, except share
and per share data)
|
|
Three Months EndedSeptember
30, |
|
Nine Months EndedSeptember
30, |
|
|
2021 |
|
|
2020 |
|
|
2021 |
|
|
2020 |
Grant revenue |
|
$ |
1,827 |
|
|
$ |
— |
|
|
$ |
5,732 |
|
|
$ |
— |
Operating expenses: |
|
|
|
|
|
|
|
|
|
|
|
Research and development |
|
|
10,883 |
|
|
|
4,752 |
|
|
|
24,713 |
|
|
|
12,338 |
|
General and administrative |
|
|
25,357 |
|
|
|
704 |
|
|
|
28,669 |
|
|
|
1,857 |
|
Total operating expenses |
|
|
36,240 |
|
|
|
5,456 |
|
|
|
53,382 |
|
|
|
14,195 |
|
Loss from operations |
|
|
(34,413 |
) |
|
|
(5,456 |
) |
|
|
(47,650 |
) |
|
|
(14,195 |
) |
Other income (expense): |
|
|
|
|
|
|
|
|
|
|
|
|
Change in fair value of embedded derivative liability |
|
|
- |
|
|
|
- |
|
|
|
(205 |
) |
|
|
- |
|
Loss on extinguishment of convertible promissory note |
|
|
- |
|
|
|
- |
|
|
|
(754 |
) |
|
|
- |
|
Interest and other income (expense) |
|
|
27 |
|
|
|
(121 |
) |
|
|
(180 |
) |
|
|
(51 |
) |
Total other income
(expense) |
|
|
27 |
|
|
|
(121 |
) |
|
|
(1,139 |
) |
|
|
(51 |
) |
Net loss and comprehensive
loss |
|
$ |
(34,386 |
) |
|
$ |
(5,577 |
) |
|
$ |
(48,789 |
) |
|
$ |
(14,246 |
) |
Net loss per share, basic and
diluted |
|
$ |
(1.30 |
) |
|
$ |
(2.40 |
) |
|
$ |
(4.50 |
) |
|
$ |
(6.66 |
) |
Weighted-average common shares outstanding, basic and diluted |
|
|
26,494,914 |
|
|
|
2,321,765 |
|
|
|
10,836,894 |
|
|
2,139,768 |
|
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