Icosavax Reports Third Quarter Financial Results and Provides Corporate Update
November 14 2022 - 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 and a vision
of creating pan-respiratory vaccines for older adults, today
reported financial results for the third quarter ended September
30, 2022 and provided a corporate update.
“The past few months have marked a pivotal
moment for Icosavax, as we advanced our vision of creating
combination vaccine candidates targeting respiratory diseases for
older adults. Specifically, we recently initiated a Phase 1 trial
for IVX-A12, which is not only our first combination VLP vaccine
candidate, but also the only bivalent vaccine candidate targeting
RSV and hMPV to reach clinical development,” said Adam Simpson,
Chief Executive Officer of Icosavax. “As we continue to work to
progress IVX-A12, we are excited by the multiple potential
inflection points that are set up for next year. Notably, we
anticipate the IVX-A12 Phase 1 topline interim data in mid-2023, as
well as six- and twelve-month immunogenicity data from the Phase 1b
extension of its RSV component IVX-121 by early- and mid-2023,
respectively. In addition, during 2023 we expect to announce the
selection of candidates for our COVID-19 and flu programs.”
Third Quarter 2022 and Subsequent
Highlights
-
Initiated Phase 1 trial of IVX-A12 against RSV and hMPV in
older adults. In October, the company announced the
initiation of a Phase 1 clinical trial of IVX-A12, a combination
bivalent RSV and hMPV VLP vaccine candidate, 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. IVX-A12 is the first candidate from
Icosavax’s novel VLP platform to receive IND authorization in the
U.S. Icosavax anticipates announcing topline results from this
Phase 1 trial in mid-2023, and subsequently plans to initiate a
Phase 2 trial for IVX-A12 in 2H 2023.
Near-Term Milestone
Expectations
- IVX-121 (RSV)
Phase 1b extension, 6-month immunogenicity data expected by early
2023
- IVX-121 (RSV)
Phase 1b extension, 12-month immunogenicity data expected in
mid-2023
- IVX-A12
(RSV+hMPV) Phase 1 topline interim data expected in mid-2023
- IVX-A12
(RSV+hMPV) Phase 2a initiation expected in 2H 2023
- COVID-19
bivalent candidate selection expected in 2023
- Flu program
candidate selection expected in 2023
Third Quarter Financial
Results
- Cash,
cash equivalents, restricted cash, and short-term
investments as of September 30, 2022 were $222.5 million,
compared to $280.7 million as of December 31, 2021. 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, 2022, were $15.5 million compared to $10.9
million for the same period in 2021. The increase was primarily
driven by increased clinical development activity, and increased
personnel related expenses and stock-based compensation expense.
Research and development expenses include non-cash stock-based
compensation expenses of $2.0 million for the three months ended
September 30, 2022.
- General
and administrative (G&A) expenses for the three months
ended September 30, 2022 were $7.7 million, compared to $25.4
million for the same period in 2021. The decrease was primarily
from lower stock-based compensation expense, due to $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) in 2021,
offset by increased personnel costs, increased professional
services and insurance costs, and other operating expenses to
support the Company’s growth. General and administrative expenses
include non-cash stock-based compensation expenses of $3.4 million
for the three months ended September 30, 2022.
- Net
loss for the three months ended September 30, 2022 was
$22.0 million, or a basic and diluted net loss per share of $0.55.
This includes non-cash stock-based compensation expense of $5.4
million. Net loss for the same period in 2021 was $34.4 million, or
a basic and diluted net loss per share of $1.30.
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) and human metapneumovirus (hMPV),
as well as programs in severe acute respiratory syndrome
coronavirus 2 (SARS-CoV-2) and 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 prophylactic and commercial potential of, its vaccine
candidates and technology platform; the company’s ability to
advance its development program and achieve the noted development
milestones in 2022 and 2023; 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 develop 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 candidate development, IND submission, 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; results from preclinical studies or early
clinical trials not necessarily being predictive of future results;
the company’s dependence on third parties in connection with
manufacturing, research, and clinical testing; the potential for
challenges encountered in the manufacturing and scale up process,
including without limitation challenges that reduce drug product
stability or potency; 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
vaccine 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; 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, 2022 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)
|
|
September 30, |
|
December 31, |
|
|
|
2022 |
|
|
|
2021 |
|
Assets |
|
|
|
|
Current assets: |
|
|
|
|
Cash and cash equivalents |
|
$ |
64,505 |
|
|
$ |
279,082 |
|
Restricted cash |
|
|
1,061 |
|
|
|
1,642 |
|
Short-term investments |
|
|
156,894 |
|
|
|
— |
|
Prepaid expenses and other current assets |
|
|
6,272 |
|
|
|
5,829 |
|
Total current assets |
|
|
228,732 |
|
|
|
286,553 |
|
Right-of-use assets –
operating leases |
|
|
3,330 |
|
|
|
— |
|
Property and equipment,
net |
|
|
11,815 |
|
|
|
1,076 |
|
Total assets |
|
$ |
243,877 |
|
|
$ |
287,629 |
|
Liabilities and
stockholders' equity |
|
|
|
|
Current liabilities: |
|
|
|
|
Accounts payable |
|
$ |
4,722 |
|
|
$ |
3,899 |
|
Accrued and other current liabilities |
|
|
6,720 |
|
|
|
4,757 |
|
Current portion of operating lease liabilities |
|
|
1,591 |
|
|
|
— |
|
Deferred revenue |
|
|
— |
|
|
|
582 |
|
Total current liabilities |
|
|
13,033 |
|
|
|
9,238 |
|
Operating lease liabilities, net of current portion |
|
|
5,089 |
|
|
|
— |
|
Other noncurrent liabilities |
|
|
93 |
|
|
|
171 |
|
Total liabilities |
|
|
18,215 |
|
|
|
9,409 |
|
Stockholders' equity: |
|
|
|
|
Common stock |
|
|
5 |
|
|
|
5 |
|
Additional paid-in capital |
|
|
388,480 |
|
|
|
372,284 |
|
Accumulated other comprehensive loss |
|
|
(609) |
|
|
|
— |
|
Accumulated deficit |
|
|
(162,214) |
|
|
|
(94,069) |
|
Total stockholders'
equity |
|
|
225,662 |
|
|
|
278,220 |
|
Total liabilities and
stockholders' equity |
|
$ |
243,877 |
|
|
$ |
287,629 |
|
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, |
|
|
|
2022 |
|
|
|
2021 |
|
|
|
2022 |
|
|
|
2021 |
|
|
|
|
|
|
|
|
Grant revenue |
|
$ |
— |
|
|
$ |
1,827 |
|
|
$ |
582 |
|
|
$ |
5,732 |
|
Operating expenses: |
|
|
|
|
|
|
|
|
Research and development |
|
|
15,484 |
|
|
|
10,883 |
|
|
|
49,217 |
|
|
|
24,713 |
|
General and administrative |
|
|
7,659 |
|
|
|
25,357 |
|
|
|
21,292 |
|
|
|
28,669 |
|
Total operating expenses |
|
|
23,143 |
|
|
|
36,240 |
|
|
|
70,509 |
|
|
|
53,382 |
|
Loss from operations |
|
|
(23,143) |
|
|
|
(34,413) |
|
|
|
(69,927) |
|
|
|
(47,650) |
|
Other income (expense): |
|
|
|
|
|
|
|
|
Change in fair value of embedded derivative liability |
|
|
— |
|
|
|
— |
|
|
|
— |
|
|
|
(205) |
|
Loss on extinguishment of convertible promissory note |
|
|
— |
|
|
|
— |
|
|
|
— |
|
|
|
(754) |
|
Interest and other |
|
|
1,167 |
|
|
|
27 |
|
|
|
1,782 |
|
|
|
(180) |
|
Total other income
(expense) |
|
|
1,167 |
|
|
|
27 |
|
|
|
1,782 |
|
|
|
(1,139) |
|
Net loss |
|
$ |
(21,976) |
|
|
$ |
(34,386) |
|
|
$ |
(68,145) |
|
|
$ |
(48,789) |
|
Comprehensive loss: |
|
|
|
|
|
|
|
|
Unrealized losses on
available-for-sale debt securities |
|
|
(334) |
|
|
|
— |
|
|
|
(609) |
|
|
|
— |
|
Comprehensive loss |
|
$ |
(22,310) |
|
|
$ |
(34,386) |
|
|
$ |
(68,754) |
|
|
$ |
(48,789) |
|
Net loss per share, basic and
diluted |
|
$ |
(0.55) |
|
|
$ |
(1.30) |
|
|
$ |
(1.72) |
|
|
$ |
(4.50) |
|
Weighted-average common shares
outstanding, basic and diluted |
|
|
39,748,984 |
|
|
|
26,494,914 |
|
|
|
39,623,357 |
|
|
|
10,836,894 |
|
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