Icosavax Reports Second Quarter 2022 Financial Results and Provides Corporate Update
August 15 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 second quarter ended June 30,
2022 and provided a corporate update.
“We are pleased with the company’s progress this
year - especially the recently announced positive topline interim
Phase 1/1b results for our VLP vaccine candidate IVX-121 against
RSV - and remain focused on continuing that momentum through the
second half of the year,” said Adam Simpson, Chief Executive
Officer of Icosavax. “IVX-121 demonstrated a robust immunologic
response, consistent across both young and older adults, a
favorable tolerability profile, and provided initial validation of
our underlying VLP technology. Based on these results, in addition
to the body of preclinical data for our hMPV VLP and the RSV/hMPV
combination VLP, we now look forward to the near-term initiation of
a Phase 1 study for our first combination vaccine candidate,
IVX-A12, against both RSV and hMPV.”
Second Quarter 2022 and Subsequent
Highlights
- Announced positive topline
interim Phase 1/1b results for VLP vaccine candidate IVX-121
against RSV. In June, the company announced positive
topline interim Phase 1/1b results for IVX-121, a VLP vaccine
candidate displaying a prefusion stabilized RSV F antigen, in young
and older adults. Icosavax is on track to advance to an
investigational new drug application (IND) and subsequent Phase 1
initiation of IVX-A12, its bivalent VLP vaccine candidate against
RSV and hMPV in 2H 2022.
- Completed end-to-end drug
product investigation of IVX-411 (COVID-19). In July,
Icosavax completed its end-to-end drug product investigation of
IVX-411. Results of the investigation confirmed the company’s
initial hypothesis that the reduced potency observed for IVX-411
was antigen-specific (i.e., related to the Receptor Binding Domain
(RBD) antigen), and data to date indicate that this antigenic
instability is not observed in other Icosavax vaccine candidates,
including for RSV and hMPV. Icosavax now intends to focus on a
bivalent strategy for COVID-19 development, with candidate
selection expected for 2023.
Near-Term Milestone
Expectations
- IND submission
and initiation of a Phase 1 trial for IVX-A12 (RSV+hMPV) expected
in 2H 2022
- 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
Second Quarter Financial
Results
- Cash and cash equivalents,
restricted cash, and short-term investments as of
June 30, 2022 were $243.9 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 June
30, 2022 were $15.8 million, compared to $8.3 million for the same
period in 2021. The increase was primarily driven by increased
preclinical development and manufacturing costs, increased
stock-based compensation expense, growth in the number of R&D
employees, and increased clinical development and manufacturing
activity. Research and development expenses include non-cash
stock-based compensation expenses of $2.2 million for the three
months ended June 30, 2022.
- General and administrative
(G&A) expenses for the three months ended June
30, 2022 were $7.3 million, compared to $2.2 million for the same
period in 2021, respectively. The increase was primarily due to
increased stock-based compensation expense, growth in the number of
G&A employees, increased insurance and professional services
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 June 30, 2022.
- Net loss for
the three months ended June 30, 2022 was $22.6 million,
or a basic and diluted net loss per share of $0.57. This includes
non-cash stock-based compensation expense of $5.6 million. Net loss
for the same period in 2021 was $8.6 million, or a basic and
diluted net loss per share of $2.86.
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 pursue 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 March 31, 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)
|
|
June 30, |
|
December 31, |
|
|
|
2022 |
|
|
|
2021 |
|
Assets |
|
|
|
|
Current assets: |
|
|
|
|
Cash and cash equivalents |
|
$ |
108,345 |
|
|
$ |
279,082 |
|
Restricted cash |
|
|
1,061 |
|
|
|
1,642 |
|
Short-term investments |
|
|
134,459 |
|
|
|
— |
|
Prepaid expenses and other current assets |
|
|
4,637 |
|
|
|
5,829 |
|
Total current assets |
|
|
248,502 |
|
|
|
286,553 |
|
Right-of-use assets –
operating leases |
|
|
3,227 |
|
|
|
— |
|
Property and equipment,
net |
|
|
7,949 |
|
|
|
1,076 |
|
Total assets |
|
$ |
259,678 |
|
|
$ |
287,629 |
|
Liabilities and
stockholders' equity (deficit) |
|
|
|
|
Current liabilities: |
|
|
|
|
Accounts payable |
|
$ |
3,485 |
|
|
$ |
3,899 |
|
Accrued and other current liabilities |
|
|
7,349 |
|
|
|
4,757 |
|
Current portion of operating lease liabilities |
|
|
1,061 |
|
|
|
— |
|
Deferred revenue |
|
|
— |
|
|
|
582 |
|
Total current liabilities |
|
|
11,895 |
|
|
|
9,238 |
|
Operating lease liabilities, net of current portion |
|
|
5,235 |
|
|
|
— |
|
Other noncurrent liabilities |
|
|
119 |
|
|
|
171 |
|
Total liabilities |
|
|
17,249 |
|
|
|
9,409 |
|
Stockholders' equity
(deficit): |
|
|
|
|
Common stock |
|
|
5 |
|
|
|
5 |
|
Additional paid-in capital |
|
|
382,937 |
|
|
|
372,284 |
|
Accumulated other comprehensive loss |
|
|
(275 |
) |
|
|
— |
|
Accumulated deficit |
|
|
(140,238 |
) |
|
|
(94,069 |
) |
Total stockholders'
equity |
|
|
242,429 |
|
|
|
278,220 |
|
Total liabilities and
stockholders' equity |
|
$ |
259,678 |
|
|
$ |
287,629 |
|
|
|
|
|
|
|
|
|
|
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, |
|
|
2022 |
|
|
|
2021 |
|
|
|
2022 |
|
|
|
2021 |
|
|
|
|
|
|
|
Grant revenue |
$ |
— |
|
|
$ |
1,904 |
|
|
$ |
582 |
|
|
$ |
3,905 |
|
Operating expenses: |
|
|
|
|
|
|
|
Research and development |
|
15,820 |
|
|
|
8,277 |
|
|
|
33,733 |
|
|
|
13,830 |
|
General and administrative |
|
7,311 |
|
|
|
2,221 |
|
|
|
13,633 |
|
|
|
3,312 |
|
Total operating expenses |
|
23,131 |
|
|
|
10,498 |
|
|
|
47,366 |
|
|
|
17,142 |
|
Loss from operations |
|
(23,131 |
) |
|
|
(8,594 |
) |
|
|
(46,784 |
) |
|
|
(13,237 |
) |
Other income (expense): |
|
|
|
|
|
|
|
Change in fair value of embedded derivative liability |
|
— |
|
|
|
— |
|
|
|
— |
|
|
|
(205 |
) |
Loss on extinguishment of convertible promissory note |
|
— |
|
|
|
— |
|
|
|
— |
|
|
|
(754 |
) |
Interest and other |
|
495 |
|
|
|
42 |
|
|
|
615 |
|
|
|
(207 |
) |
Total other income
(expense) |
|
495 |
|
|
|
42 |
|
|
|
615 |
|
|
|
(1,166 |
) |
Net loss |
$ |
(22,636 |
) |
|
$ |
(8,552 |
) |
|
$ |
(46,169 |
) |
|
$ |
(14,403 |
) |
Comprehensive loss: |
|
|
|
|
|
|
|
Unrealized losses on
available-for-sale debt securities |
|
(275 |
) |
|
|
— |
|
|
|
(275 |
) |
|
|
— |
|
Comprehensive loss |
$ |
(22,911 |
) |
|
$ |
(8,552 |
) |
|
$ |
(46,444 |
) |
|
$ |
(14,403 |
) |
Net loss per share, basic and
diluted |
$ |
(0.57 |
) |
|
$ |
(2.86 |
) |
|
$ |
(1.17 |
) |
|
$ |
(5.00 |
) |
Weighted-average common shares
outstanding, basic and diluted |
|
39,594,028 |
|
|
|
2,985,183 |
|
|
|
39,524,408 |
|
|
|
2,878,163 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
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