Icosavax Reports First Quarter 2022 Financial Results and Provides Corporate Update
May 16 2022 - 3:05PM
Icosavax, Inc. (Nasdaq: ICVX), a biopharmaceutical company
leveraging its innovative virus-like particle platform technology
to develop combination 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 first quarter ended March 31,
2022 and provided a corporate update.
“Icosavax looks forward to announcing topline,
interim Phase 1/1b data for IVX-121 in RSV, in June. Contingent on
favorable data from this readout, we then plan to initiate a Phase
1 clinical trial of our first combination vaccine candidate and
lead program, IVX-A12, for RSV and human metapneumovirus (hMPV) in
the second half of the year,” said Adam Simpson, Chief Executive
Officer of Icosavax. “We believe a combination RSV/hMPV vaccine
represents a significant opportunity to address two leading causes
of pneumonia, each of which currently lack an approved vaccine. As
such, we look forward to providing additional corporate and
clinical updates in coming months as we work towards our vision of
creating pan-respiratory and combination vaccines.”
First Quarter 2022 and Subsequent
Highlights
- Completed enrollment in
older adults portion of Phase 1/1b clinical trial of
IVX-121. During the quarter, Icosavax completed dosing in
the Phase 1b (older adults; n=130) portion of its ongoing Phase
1/1b clinical trial of IVX-121. The Phase 1 (younger adults; n=90)
portion had previously completed dosing. A subset of the Phase 1b
older adult cohort is expected to be followed for up to 12 months
after vaccination to assess the durability of response to
IVX-121.
- Announced topline, interim
Phase 1/2 results for IVX-411 against SARS-CoV-2. In
March, Icosavax reported topline, interim data for IVX-411, a VLP
vaccine candidate displaying the SARS-CoV-2 receptor-binding domain
(RBD). Immunologic response was observed in both SARS-CoV-2 naive
and previously vaccinated subjects, but at lower-than-expected
levels that were inconsistent with known data about VLPs, including
from clinical studies in COVID-19 and the company’s own preclinical
data. As a result, the company is conducting an end-to-end drug
product investigation to better understand the results and
determine a path forward for its COVID-19 program.
- Expanded antigen design
capabilities. During the first quarter and subsequently,
Icosavax has expanded its laboratories and staff to add
computational antigen design capabilities, which could enable the
company to further build the pipeline, addressing pathogens and
targets that have proven difficult under conventional vaccine
approaches or where an optimized immune response could be
beneficial.
Near-Term Milestone
Expectations
- IVX-121 (RSV) Phase 1/1b topline,
interim data from younger and older adults expected in June
2022
- Provide update on IVX-411 (Covid)
following company’s end-to-end investigation
- IND submission and initiation of a
Phase 1 trial or IVX-A12 (RSV+hMPV) expected in 2H 2022
First Quarter Financial
Results
- Cash and restricted
cash as of March 31, 2022 was $262.4 million,
compared to $280.7 million for the period ended 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 March
31, 2022 were $17.9 million, compared to $5.6 million for the same
period in 2021. The increase was primarily driven by increased
preclinical development and manufacturing costs, growth in the
number of R&D employees, increased stock-based compensation
expense, and increased clinical development and manufacturing
activity. Research and development expenses include non-cash
stock-based compensation expenses of $1.7 million for the three
months ended March 31, 2022.
- General and administrative
(G&A) expenses for the three months ended March
31, 2022 were $6.3 million compared to $1.1 million for the same
period in 2021. The increase was primarily due to increased
stock-based compensation expense, growth in the number of G&A
employees, 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 $2.9 million for the three months ended
March 31, 2022.
- Net loss for
the three months ended March 31, 2022 was $23.5 million,
or a basic and diluted net loss per share of $0.60. This includes
non-cash stock-based compensation expense of $4.6 million. Net loss
for the same period in 2021 was $5.9 million or a basic and diluted
net loss per share of $2.11.
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), human metapneumovirus (hMPV) and
severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2), and
an emerging program in 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 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 immunogenicity or
efficacy of the company’s product candidates that may limit their
development, regulatory approval, and/or commercialization; the
potential for the drug product investigation relating
to IVX-411 to produce inconclusive results; the potential
that, even if the investigation identifies a root cause or
contributing factors for the lower than
expected IVX-411 interim topline immunogenicity data, the
company may be unable to resolve all ambiguity; the potential for
the investigation into IVX-411 interim results to impact
the results of the company’s ongoing trial
for IVX-121; the possibility of disappointing results in
later clinical trials despite promising results in earlier
preclinical research or clinical trials; 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 annual report on
Form 10-K for the year ended December 31, 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)
|
|
March 31,2022 |
|
|
|
December 31,2021 |
|
Assets |
|
|
|
Current assets: |
|
|
|
Cash |
$ |
261,357 |
|
|
$ |
279,082 |
|
Restricted cash |
|
1,061 |
|
|
|
1,642 |
|
Prepaid expenses and other current assets |
|
7,681 |
|
|
|
5,829 |
|
Total current assets |
|
270,099 |
|
|
|
286,553 |
|
Right-of-use assets –
operating leases |
|
3,309 |
|
|
|
— |
|
Property and equipment,
net |
|
3,237 |
|
|
|
1,076 |
|
Total assets |
$ |
276,645 |
|
|
$ |
287,629 |
|
Liabilities and
stockholders' equity (deficit) |
|
|
|
Current liabilities: |
|
|
|
Accounts payable |
$ |
6,019 |
|
|
$ |
3,899 |
|
Accrued and other current liabilities |
|
7,448 |
|
|
|
4,757 |
|
Current portion of operating lease liabilities |
|
530 |
|
|
|
— |
|
Deferred revenue |
|
— |
|
|
|
582 |
|
Total current liabilities |
|
13,997 |
|
|
|
9,238 |
|
Operating lease liabilities, net of current portion |
|
2,964 |
|
|
|
— |
|
Other noncurrent liabilities |
|
144 |
|
|
|
171 |
|
Total liabilities |
|
17,105 |
|
|
|
9,409 |
|
Stockholders' equity
(deficit): |
|
|
|
Common stock |
|
5 |
|
|
|
5 |
|
Additional paid-in capital |
|
377,137 |
|
|
|
372,284 |
|
Accumulated deficit |
|
(117,602 |
) |
|
|
(94,069 |
) |
Total stockholders' equity
(deficit) |
|
259,540 |
|
|
|
278,220 |
|
Total liabilities and
stockholders' equity (deficit) |
$ |
276,645 |
|
|
$ |
287,629 |
|
ICOSAVAX, INC.
Condensed Statements of Operations and
Comprehensive Loss (Unaudited) (in thousands, except share
and per share data)
|
Three Months EndedMarch 31, |
|
|
2022 |
|
|
|
2021 |
|
|
|
Grant revenue |
$ |
582 |
|
|
$ |
2,001 |
|
Operating expenses: |
|
|
|
|
|
|
|
Research and development |
|
17,913 |
|
|
|
5,553 |
|
General and administrative |
|
6,322 |
|
|
|
1,091 |
|
Total operating expenses |
|
24,235 |
|
|
|
6,644 |
|
Loss from operations |
|
(23,653 |
) |
|
|
(4,643 |
) |
Other income (expense): |
|
|
|
|
|
|
|
Change in fair value of embedded derivative liability |
|
- |
|
|
|
(205 |
) |
Loss on extinguishment of convertible promissory note |
|
- |
|
|
|
(754 |
) |
Interest and other |
|
120 |
|
|
|
(249 |
) |
Total other income
(expense) |
|
120 |
|
|
|
(1,208 |
) |
Net loss and comprehensive
loss |
$ |
(23,533 |
) |
|
$ |
(5,851 |
) |
Net loss per share, basic and
diluted |
$ |
(0.60 |
) |
|
$ |
(2.11 |
) |
Weighted-average common shares
outstanding, basic and diluted |
|
39,401,805 |
|
|
|
2,769,962 |
|
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