Icosavax Reports Second Quarter 2023 Financial Results and Provides Corporate Update
14 Agosto 2023 - 5:05PM
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 second quarter ended June 30,
2023 and provided a corporate update.
“The first half of 2023 has been particularly
productive for Icosavax, highlighted by our positive topline
interim Phase 1 data and the initiation of a Phase 2 trial for
IVX-A12, our potential first-in-class bivalent vaccine candidate
for RSV and hMPV,” said Adam Simpson, Chief Executive Officer of
Icosavax. “From our Phase 1b extension trial of IVX-121 in RSV, we
recently announced positive 12-month immunogenicity and initial
revaccination data; these were exciting because better durability
and improved response to boosting are potential opportunities for
differentiation of our VLP technology. Looking ahead we have
additional near-term clinical milestones, including topline interim
data from our Phase 2 study of IVX-A12 by the end of the year.”
Second Quarter 2023 and Subsequent
Highlights
- Reported
positive topline interim phase 1 results for bivalent VLP vaccine
candidate IVX-A12 against RSV and hMPV in older adults. In
May 2023, Icosavax announced positive topline interim results from
a Phase 1 clinical trial of IVX-A12 against respiratory syncytial
virus (RSV) and human metapneumovirus (hMPV) in older adults.
IVX-A12 is comprised of IVX-121, Icosavax’s RSV prefusion F protein
VLP vaccine candidate, and IVX-241, Icosavax’s hMPV prefusion F
protein VLP vaccine candidate. In this Phase 1 trial, IVX-A12
induced robust immune responses against both RSV and hMPV at day 28
in older adults, with no evidence of immune interference between
RSV and hMPV VLPs administered in combination, and was generally
well-tolerated across all dosage groups.
-
Initiated Phase 2 clinical trial of IVX-A12 against RSV and
hMPV in older adults. In June 2023, Icosavax announced the
initiation of a Phase 2 clinical trial of IVX-A12 in older adults.
Dosing has been completed and topline interim data is now expected
by the end of 2023.
-
Reported positive 12-month durability data for IVX-121
against RSV and initial evidence for revaccination
potential. In August 2023, Icosavax provided a 12-month
immunogenicity 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. The company
also reported initial evidence for revaccination potential with its
VLP-based vaccines, including robust immune responses against RSV-A
in Phase 1b extension trial participants who received 75 µg
unadjuvanted IVX-121 at one year after their first dose.
-
Completed a $67.8 million registered direct offering of
common stock. In May 2023, Icosavax closed a registered
direct offering of 8,369,754 shares of its common stock at a
purchase price of $8.10 per share. The $67.8 million financing was
led by new investor TCGX with participation by additional new
investors including Logos Capital and Vivo Capital.
-
Appointed Dr. M. Amin Khan, PhD as Executive Vice
President, Head of Research and Development. During the
quarter, Icosavax appointed Dr. M. Amin Khan as the company’s Head
of Research and Development. Dr. Khan has more than 30 years’
experience in vaccine and pharmaceutical R&D, including senior
scientific and executive leadership roles at Eli Lilly, Novartis
and GlaxoSmithKline. He has guided scientific and technical teams
to develop novel vaccines for infectious diseases including targets
for RSV, influenza, meningitis, group B streptococcus, S.
aureus, COPD, CMV, herpes zoster and SARS-Cov-2, and has
contributed to the licensure of four vaccines.
Near-Term Milestone
Expectations
- IVX-A12
(RSV + hMPV) Phase 2 topline interim data expected by end 2023
- IVX-A12
(RSV+ hMPV) Phase 1 six-month immunogenicity data expected in 1Q
2024
- Other
indications: no changes to milestones related to Flu and COVID-19
programs
Second Quarter Financial
Results
- Cash and
cash equivalents and short-term investments as of
June 30, 2023 was $246.9 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 June 30, 2023 were $19.9 million, compared to $15.8
million for the same period in 2022. The increase was primarily
driven by increased clinical development activity, increased
personnel related expenses and stock-based compensation expense,
increased expenses primarily related to facilities costs, and
increased development-related consulting costs, partially offset by
decreased preclinical development and manufacturing activity.
Research and development expenses include non-cash stock-based
compensation expenses of $2.4 million for the three months ended
June 30, 2023.
- General
and administrative (G&A) expenses for the three
months ended June 30, 2023 were $9.1 million compared to $7.3
million for the same period in 2022. The increase was primarily due
to increased expenses related to facilities costs to support the
company’s growth, increased stock-based compensation expense,
increased professional services, 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 June 30, 2023.
- Net
loss for the three months ended June
30, 2023 was $26.5 million, or a basic and diluted net
loss per share of $0.59. This includes non-cash stock-based
compensation expense of $6.3 million. Net loss for the same period
in 2022 was $22.6 million or a basic and diluted net loss per share
of $0.57.
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 lead program is a combination vaccine candidate
targeting respiratory syncytial virus (RSV) and human
metapneumovirus (hMPV), and its pipeline includes additional
programs in influenza 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 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 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;
difficulties in developing an hMPV challenge model and the risk
that the planned challenge study may produce negative or
inconclusive results based on such model or otherwise; 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 March 31, 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)
|
|
June 30, |
|
December 31, |
|
|
|
2023 |
|
|
|
2022 |
|
Assets |
|
|
|
|
Current
assets: |
|
|
|
|
Cash and cash equivalents |
|
$ |
155,073 |
|
|
$ |
58,846 |
|
Restricted cash |
|
|
- |
|
|
|
1,061 |
|
Short-term investments |
|
|
91,860 |
|
|
|
159,461 |
|
Prepaid expenses and other current assets |
|
|
4,766 |
|
|
|
4,545 |
|
Total
current assets |
|
|
251,699 |
|
|
|
223,913 |
|
Right-of-use
assets - operating leases |
|
|
3,072 |
|
|
|
3,247 |
|
Property and
equipment, net |
|
|
12,131 |
|
|
|
11,517 |
|
Other
noncurrent assets |
|
|
2,124 |
|
|
|
- |
|
Total
assets |
|
$ |
269,026 |
|
|
$ |
238,677 |
|
Liabilities and stockholders' equity |
|
|
|
|
Current
liabilities: |
|
|
|
|
Accounts payable |
|
$ |
1,547 |
|
|
$ |
2,892 |
|
Accrued and other current liabilities |
|
|
11,298 |
|
|
|
8,759 |
|
Current portion of operating lease liabilities |
|
|
2,169 |
|
|
|
2,137 |
|
Total
current liabilities |
|
|
15,014 |
|
|
|
13,788 |
|
Operating lease liabilities, net of current portion |
|
|
6,272 |
|
|
|
6,658 |
|
Other noncurrent liabilities |
|
|
18 |
|
|
|
69 |
|
Total
liabilities |
|
|
21,304 |
|
|
|
20,515 |
|
Stockholders' equity: |
|
|
|
|
Common stock |
|
|
7 |
|
|
|
6 |
|
Additional paid-in capital |
|
|
484,666 |
|
|
|
404,386 |
|
Accumulated other comprehensive loss |
|
|
(66 |
) |
|
|
(403 |
) |
Accumulated deficit |
|
|
(236,885 |
) |
|
|
(185,827 |
) |
Total
stockholders' equity |
|
|
247,722 |
|
|
|
218,162 |
|
Total
liabilities and stockholders' equity |
|
$ |
269,026 |
|
|
$ |
238,677 |
|
|
|
|
|
|
ICOSAVAX, INC.
Condensed Statements of Operations and
Comprehensive Loss
(Unaudited)
(in thousands, except share and per share
data)
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Three Months Ended June 30, |
|
Six Months Ended June 30, |
|
|
|
2023 |
|
|
|
2022 |
|
|
|
2023 |
|
|
|
2022 |
|
|
|
|
|
|
Grant
revenue |
|
$ |
- |
|
|
$ |
- |
|
|
$ |
- |
|
|
$ |
582 |
|
Operating
expenses: |
|
|
|
|
|
|
|
|
Research and development |
|
|
19,826 |
|
|
|
15,820 |
|
|
|
37,183 |
|
|
|
33,733 |
|
General and administrative |
|
|
9,129 |
|
|
|
7,311 |
|
|
|
18,294 |
|
|
|
13,633 |
|
Total
operating expenses |
|
|
28,955 |
|
|
|
23,131 |
|
|
|
55,477 |
|
|
|
47,366 |
|
Loss from
operations |
|
|
(28,955 |
) |
|
|
(23,131 |
) |
|
|
(55,477 |
) |
|
|
(46,784 |
) |
Other
income: |
|
|
|
|
|
|
|
|
Interest and other income |
|
|
2,458 |
|
|
|
495 |
|
|
|
4,419 |
|
|
|
615 |
|
Total other
income |
|
|
2,458 |
|
|
|
495 |
|
|
|
4,419 |
|
|
|
615 |
|
Net
loss |
|
$ |
(26,497 |
) |
|
$ |
(22,636 |
) |
|
$ |
(51,058 |
) |
|
$ |
(46,169 |
) |
Other
comprehensive (loss) income: |
|
|
|
|
|
|
|
|
Unrealized
(losses) gains on available-for-sale debt securities |
|
|
(3 |
) |
|
|
(275 |
) |
|
|
337 |
|
|
|
(275 |
) |
Comprehensive loss |
|
$ |
(26,500 |
) |
|
$ |
(22,911 |
) |
|
$ |
(50,721 |
) |
|
$ |
(46,444 |
) |
Net loss per
share, basic and diluted |
|
$ |
(0.59 |
) |
|
$ |
(0.57 |
) |
|
$ |
(1.19 |
) |
|
$ |
(1.17 |
) |
Weighted-average common shares outstanding, basic and diluted |
|
|
44,770,820 |
|
|
|
39,594,028 |
|
|
|
43,042,461 |
|
|
|
39,524,408 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
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