Icosavax Reports Second Quarter 2021 Financial Results and Provides Corporate Update
September 13 2021 - 4:05PM
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 second quarter ended June 30,
2021 and provided a corporate update.
“The second quarter and recent period has been a
transformational time for Icosavax thanks to our initiation of two
clinical trials, one in RSV and one in SARS-CoV-2, as well as our
successful initial public offering and listing on the Nasdaq stock
exchange. I would like to thank the entire Icosavax team for their
hard work during this period, and I believe our company is now
well-positioned to further advance the development of our VLP
vaccine pipeline,” said Adam Simpson, Chief Executive Officer of
Icosavax. “Our novel VLP platform has shown promise to drive a
robust, broad, and durable protective immune response to complex
antigens. To this end, we are delighted to have recently initiated
the Phase 1/1b trial of our RSV VLP vaccine candidate, IVX-121, in
addition to the Phase 1/2 trial of our COVID-19 VLP vaccine
candidate, IVX-411, and we look forward to providing future updates
on these and our other programs.”
Second 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 displaying an RSV
stabilized pre-fusion 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 candidate, Icosavax
plans to thereafter initiate a Phase 1 clinical trial of its
IVX-A12 bivalent RSV/hMPV vaccine candidate.
- Completed successful IPO;
listed on Nasdaq. In July, Icosavax successfully priced
its initial public offering raising gross proceeds of $209.3
million prior to deducting underwriting fees, commissions and
offering expenses, expected to enable the company to fund its
operations through at least 2024. Icosavax’s common stock began
trading on the Nasdaq Global Select Market under the ticker symbol
“ICVX” on July 29, 2021.
- Initiated a Phase 1/2
clinical trial of IVX-411. In June, Icosavax initiated a
Phase 1/2 clinical trial to assess the safety and immunogenicity of
IVX-411, the company’s VLP displaying the SARS-CoV-2
receptor-binding domain. Part 1 of this trial, in adults who have
neither had COVID-19 nor been vaccinated with a licensed COVID-19
vaccine, has completed dosing, and Part 2 of this trial, in adults
who have previously completed a vaccine regimen using a licensed
COVID-19 vaccine, has now been initiated.
- Appointed Elizabeth
Bekiroglu as General Counsel. In September, Icosavax
appointed Elizabeth Bekiroglu as the company’s General Counsel. Ms.
Bekiroglu has over 15 years of experience advising pharmaceutical
and biotechnology companies on a broad range of legal matters. Ms.
Bekiroglu most recently served as Associate General Counsel for
Seagen, where she helped lead and build the legal affairs group as
Seagen transformed into a multi-product, multinational
company.
- Appointed Thomas Russo as
Chief Financial Officer. In June, Thomas Russo was
appointed as Chief Financial Officer. Mr. Russo is a seasoned
financial executive who joins the company with more than 25 years
of diverse industry experience across finance, operations and
sell-side equity research for public biotechnology companies. Prior
to Icosavax, Mr. Russo most recently served as Chief Financial
Officer of Assembly Biosciences, where he contributed to financings
both through the capital markets and non-dilutive sources.
- Appointed additional Board
members. Icosavax appointed Heidi Kunz and Ann Veneman to
the Board of Directors in May and July 2021, respectively. Ms. Kunz
is a seasoned healthcare executive who sits on the Boards of
several healthcare companies and most recently served as Executive
Vice President and CFO of Blue Shield of California. Ms. Veneman
has a distinguished career in public service, most recently serving
as the Executive Director of the United Nations Children’s Fund
(UNICEF). Additionally, Mark McDade, who has served on Icosavax’s
Board of Directors since August 2019, was elected to chair the
Board in August 2021 following the sudden passing of the company’s
co-founder and former Board Chair, Tadataka (Tachi) Yamada.
Icosavax paid tribute to Tachi Yamada and his impact on public
health during a Nasdaq closing bell ceremony in August 2021.
- Completed successful Series
B financing. In April, Icosavax announced closing of a
$100 million Series B financing led by RA Capital Management and
joined by Janus Henderson Investors, Perceptive Advisors, Viking
Global Investors, Cormorant Asset Management, Omega Funds, and
Surveyor Capital (a Citadel company) as well as existing investors.
In conjunction with the financing, Peter Kolchinsky, Ph.D., founder
and managing partner of RA Capital Management, joined the company’s
Board of Directors.
Near-Term Milestone
Expectations
- Phase 1/2 interim/topline data for
IVX-411, in 1H 2022
- Phase 1/1b interim/topline data for
IVX-121, in 1H 2022
- IND submission for IVX-A12, a
combination bivalent RSV/human Metapneumovirus (hMPV) VLP vaccine
candidate, in 1H 2022
Second Quarter 2021 Financial
Results
- Cash, cash equivalents and
short-term investments as of June 30, 2021 were
$111.8 million, compared to $15.5 million for the period ended
December 31, 2020. Subsequently, in July, the company raised $190.6
million in net proceeds from its initial public offering. 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 June
30, 2021 were $8.3 million, compared to $4.7 million for the same
period in 2020. The increase was primarily driven by increased
clinical development and manufacturing costs, growth in the number
of R&D employees, non-clinical development and manufacturing
activity, and stock-based compensation expense. Research and
development expenses include non-cash stock-based compensation
expense of $0.4 million for the three months ended June 30, 2021
versus an immaterial amount for the same period in 2020.
- General and administrative
expenses for the three months ended June 30, 2021
were $2.2 million, compared to $0.5 million for the same period in
2020. The increase was primarily due to increased stock-based
compensation expense, growth in the number of G&A employees,
and professional services including legal fees to support the
company’s growth. General and administrative expenses include
non-cash stock-based compensation expenses of $0.9 million for the
three months ended June 30, 2021 versus an immaterial amount for
the same period in 2020.
- Net loss for
the three months ended June 30, 2021 was $8.6 million, or
a basic and diluted net loss per share attributable to common
stockholders of $2.86. Net loss for the same period in 2020 was
$5.2 million, or basic and diluted net loss per share attributable
to common stockholders of $2.45.
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 Registration Statement on Form S-1 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 (in
thousands, except share and par value data) (Unaudited)
|
|
June 30, |
|
|
December 31, |
|
|
|
2021 |
|
|
2020 |
|
Assets |
|
|
|
|
|
|
Current assets: |
|
|
|
|
|
|
Cash |
|
$ |
110,585 |
|
|
$ |
13,114 |
|
Restricted cash |
|
|
1,179 |
|
|
|
2,384 |
|
Prepaid expenses and other current assets |
|
|
4,119 |
|
|
|
662 |
|
Total current assets |
|
|
115,883 |
|
|
|
16,160 |
|
Property and equipment,
net |
|
|
561 |
|
|
|
10 |
|
Deferred offering costs |
|
|
2,265 |
|
|
|
— |
|
Total assets |
|
$ |
118,709 |
|
|
$ |
16,170 |
|
Liabilities,
convertible preferred stock, and stockholders'
deficit |
|
|
|
|
|
|
Current liabilities: |
|
|
|
|
|
|
Accounts payable |
|
$ |
3,111 |
|
|
$ |
1,918 |
|
Accrued and other current liabilities |
|
|
1,825 |
|
|
|
1,532 |
|
Deferred revenue |
|
|
1,179 |
|
|
|
2,384 |
|
Total current liabilities |
|
|
6,115 |
|
|
|
5,834 |
|
Long-term convertible promissory note |
|
|
— |
|
|
|
4,947 |
|
Embedded derivative liability |
|
|
— |
|
|
|
1,604 |
|
Other noncurrent liabilities |
|
|
279 |
|
|
|
426 |
|
Total liabilities |
|
|
6,394 |
|
|
|
12,811 |
|
Convertible preferred stock,
$0.0001 par value; 89,908,215 and 54,039,749 shares authorized at
June 30, 2021 and December 31, 2020, respectively; 89,908,215 and
32,198,879 shares issued and outstanding at June 30, 2021 and
December 31, 2020, respectively |
|
151,613 |
|
|
|
30,062 |
|
Total stockholders'
deficit |
|
|
(39,298 |
) |
|
|
(26,703 |
) |
Total liabilities, convertible
preferred stock and stockholders' deficit |
|
$ |
118,709 |
|
|
$ |
16,170 |
|
|
|
|
|
|
|
|
|
|
ICOSAVAX, INC.
Condensed Statements of Operations and
Comprehensive Loss (Unaudited) (in thousands, except share
and per share data)
|
|
Three Months EndedJune 30, |
|
|
Six Months EndedJune 30, |
|
|
|
2021 |
|
|
2020 |
|
|
2021 |
|
|
2020 |
|
Grant revenue |
|
$ |
1,904 |
|
|
$ |
— |
|
|
$ |
3,905 |
|
|
$ |
— |
|
Operating expenses: |
|
|
|
|
|
|
|
|
|
|
|
|
Research and development |
|
|
8,277 |
|
|
|
4,666 |
|
|
|
13,830 |
|
|
|
7,586 |
|
General and administrative |
|
|
2,221 |
|
|
|
541 |
|
|
|
3,312 |
|
|
|
1,153 |
|
Total operating expenses |
|
|
10,498 |
|
|
|
5,207 |
|
|
|
17,142 |
|
|
|
8,739 |
|
Loss from operations |
|
|
(8,594 |
) |
|
|
(5,207 |
) |
|
|
(13,237 |
) |
|
|
(8,739 |
) |
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) |
|
|
42 |
|
|
|
9 |
|
|
|
(207 |
) |
|
|
70 |
|
Total other income
(expense) |
|
|
42 |
|
|
|
9 |
|
|
|
(1,166 |
) |
|
|
70 |
|
Net loss and comprehensive
loss |
|
$ |
(8,552 |
) |
|
$ |
(5,198 |
) |
|
$ |
(14,403 |
) |
|
$ |
(8,669 |
) |
Net loss per share, basic and
diluted |
|
$ |
(2.86 |
) |
|
$ |
(2.45 |
) |
|
$ |
(5.00 |
) |
|
$ |
(4.23 |
) |
Weighted-average common shares
outstanding, basic and diluted |
|
|
2,985,183 |
|
|
|
2,119,312 |
|
|
|
2,878,163 |
|
|
|
2,047,803 |
|
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