Vaxcyte Reports Second Quarter 2020 Financial Results and Provides Business Update
August 12 2020 - 4:10PM
Vaxcyte, Inc., formerly known as SutroVax, a next-generation
vaccine company seeking to improve global health by developing
superior and novel vaccines designed to prevent or treat some of
the most common and deadly infectious diseases worldwide, today
announced financial results for the second quarter ended June 30,
2020 and provided a business update.
“Despite the pandemic, the first half of 2020 was marked by
significant progress across all aspects of our business,
culminating with our successful initial public offering,” said
Grant Pickering, Chief Executive Officer and Co-founder of Vaxcyte.
“With key additions to our leadership team and the completion of
both our Series D financing and IPO in the past several months, we
are well positioned to execute our strategy and advance our
pipeline of novel vaccine candidates, led by VAX-24, our 24-valent
investigational pneumococcal conjugate vaccine.”
Recent Highlights
- Completed Upsized Initial Public Offering
(IPO): On June 16, 2010, Vaxcyte completed its IPO of
17,968,750 shares of common stock, which included the full exercise
of the underwriters’ option to purchase 2,343,750 additional
shares, at a public offering price of $16.00 per share, resulting
in aggregate net proceeds of $264.1 million.
- Achieved VAX-24 Manufacturing Milestones:
Vaxcyte achieved several key manufacturing milestones for VAX-24,
its lead vaccine candidate, including release of the good
manufacturing practices (GMP) batches of the eCRM protein carrier,
completion of the GMP batches of the 24 polysaccharide antigens and
initiation of the GMP batches of the conjugate drug substances.
VAX-24 is the Company’s 24-valent pneumococcal conjugate vaccine
(PCV) candidate being developed for the prevention of invasive
pneumococcal disease (IPD).
- Amended CARB-X Agreement for VAX-A1 Program:
In July 2020, Vaxcyte’s grant from CARB-X related to its VAX-A1
vaccine candidate was increased from 50% to 90% of reimbursable
expenses during the initial funding period. VAX-A1 is a novel
conjugate vaccine designed to provide universal protection from
infections caused by Group A Strep bacteria, which include
pharyngitis, toxic shock syndrome and necrotizing fasciitis.
- Strengthened Executive Leadership and Board:
In May 2020, Vaxcyte appointed Andrew Guggenhime as Chief Financial
Officer and Chief Business Officer, bringing more than two decades
of financial and strategic leadership experience in healthcare. In
April 2020, Vaxcyte appointed Halley Gilbert to its board of
directors, bringing over 20 years of biotechnology leadership
experience.
Anticipated Milestones
- VAX-24: Vaxcyte expects to submit an
Investigational New Drug (IND) application for VAX-24 to the U.S.
Food and Drug Administration (FDA) and initiate its Phase 1/2
clinical proof-of-concept study in the second half of 2021. Vaxcyte
expects to announce topline data from this study in 2022.
- VAX-A1: Vaxcyte expects to nominate a final
vaccine candidate for VAX-A1 in 2021.
- VAX-PG: Vaxcyte expects to nominate a final
vaccine candidate for VAX-PG, its novel therapeutic vaccine
designed to treat periodontal disease, in 2021.
Second Quarter 2020 Financial Results
- Cash Position: Cash and cash equivalents were
$410.0 million as of June 30, 2010, compared to $59.0 million as of
December 31, 2019, an increase due to Vaxcyte’s IPO in June 2020
and Series D financing in March 2020.
- Research & Development (R&D) Expenses:
R&D expenses were $18.2 million for the three months ended June
30, 2020 as compared to $10.0 million for the same period in 2019.
The increase was due primarily to an increase in manufacturing
expenses related to the Company’s VAX-24 program.
- General & Administrative (G&A)
Expenses: G&A expenses were $3.0 million for the three
months ended June 30, 2020 as compared to $2.3 million for the same
period in 2019. The increase was due primarily to an increase in
personnel-related expenses.
- Net Loss: For the three months ended June 30,
2020, net loss was $20.3 million, compared to $10.7 million for the
three months ended June 30, 2019.
About VaxcyteVaxcyte is a next-generation
vaccine company seeking to improve global health by developing
superior and novel vaccines designed to prevent or treat some of
the most common and deadly infectious diseases worldwide. The
Company’s cell-free protein synthesis platform, comprising the
XpressCFTM platform, exclusively licensed from Sutro Biopharma,
Inc., together with Vaxcyte’s proprietary know-how, enables the
design and production of protein carriers and antigens, the
critical building blocks of vaccines, in ways that the Company
believes conventional vaccine technologies currently cannot.
Vaxcyte’s lead vaccine candidate, VAX-24, is a preclinical,
24-valent broad-spectrum pneumococcal conjugate vaccine (PCV) being
developed for the prevention of invasive pneumococcal disease
(IPD). Vaxcyte’s pipeline also includes VAX-XP, a PCV with an
expanded breadth of coverage of at least 30 strains, including
newly emerging strains responsible for IPD and antibiotic
resistance; VAX-A1, a prophylactic vaccine candidate designed to
prevent Group A Strep infections; and VAX-PG, a therapeutic vaccine
candidate designed to slow or stop the progression of periodontal
disease by targeting the keystone pathogen responsible for this
chronic, oral inflammatory disease. For more information, visit
www.vaxcyte.com.
Forward-Looking StatementsThis press release
contains forward-looking statements within the meaning of The
Private Securities Litigation Reform Act of 1995. These statements
include, but are not limited to, statements related to the process
and timing of anticipated future development of Vaxcyte’s vaccine
candidates, including VAX-24, VAX-XP, VAX-A1 and VAX-PG. The
words “anticipate,” “believe,” “continue,” “could,” “estimate,”
“expect,” “intend,” “may,” “plan,” “potential,” “predict,”
“project,” “should,” “target,” “will,” “would” and similar
expressions are intended to identify forward-looking statements,
although not all forward-looking statements contain these
identifying words. These forward-looking statements are based
on Vaxcyte’s current expectations and actual results and
timing of events could differ materially from those anticipated in
such forward-looking statements as a result of risks and
uncertainties, including, without limitation, risks related
to Vaxcyte’s product development programs, including
development timelines, success and timing of chemistry,
manufacturing and controls and related manufacturing activities,
potential delays or inability to obtain and maintain required
regulatory approvals for its vaccine candidates, and the risks and
uncertainties inherent with preclinical and clinical development
processes; the success, cost and timing of all development
activities and clinical trials; and sufficiency of cash and other
funding to support Vaxcyte’s development programs and other
operating expenses. These and other risks are described more fully
in Vaxcyte’s filings with the Securities and Exchange Commission
(SEC), including its Quarterly Report on Form 10-Q filed with
the SEC on August 12, 2020, its prospectus dated
June 11, 2020 filed with the SEC on June 15, 2020 or in other
documents Vaxcyte subsequently files with or furnishes to the SEC.
Vaxcyte undertakes no duty or obligation to update any
forward-looking statements contained in this release as a result of
new information, future events or changes in its expectations.
Readers should not rely upon the information in this press release
as current or accurate after its publication date.
Investor Contact:Andrew Guggenhime, Chief
Financial Officer & Chief Business OfficerVaxcyte,
Inc.650-837-0111investors@vaxcyte.com
Vaxcyte,
Inc. |
|
Condensed
Statements of Operations |
|
(in
thousands, except share and per share amounts) |
|
(unaudited) |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Three Months
Ended |
|
Six Months
Ended |
|
|
|
June 30, |
|
June 30, |
|
|
|
|
2020 |
|
|
|
2019 |
|
|
|
2020 |
|
|
|
2019 |
|
|
Operating
expenses: |
|
|
|
|
|
|
|
|
|
Research and development (1) |
|
$ |
18,178 |
|
|
$ |
9,968 |
|
|
$ |
42,493 |
|
|
$ |
22,595 |
|
|
General and administrative (1) |
|
|
3,046 |
|
|
|
2,264 |
|
|
|
6,327 |
|
|
|
3,580 |
|
|
Total operating expenses |
|
|
21,224 |
|
|
|
12,232 |
|
|
|
48,820 |
|
|
|
26,175 |
|
|
|
|
|
|
|
|
|
|
|
|
Loss from
operations |
|
|
(21,224 |
) |
|
|
(12,232 |
) |
|
|
(48,820 |
) |
|
|
(26,175 |
) |
|
Other income
(expense), net |
|
|
|
|
|
|
|
|
|
Interest expense |
|
|
— |
|
|
|
(11 |
) |
|
|
(7 |
) |
|
|
(24 |
) |
|
Interest income |
|
|
44 |
|
|
|
181 |
|
|
|
179 |
|
|
|
418 |
|
|
Grant income |
|
|
1,036 |
|
|
|
— |
|
|
|
1,365 |
|
|
|
— |
|
|
Foreign currency transaction losses |
|
|
(176 |
) |
|
|
(53 |
) |
|
|
(179 |
) |
|
|
(231 |
) |
|
Change in fair value of the redeemable convertible preferred stock
tranche liability |
|
|
— |
|
|
|
1,450 |
|
|
|
— |
|
|
|
1,676 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Total other income (expense), net |
|
|
904 |
|
|
|
1,567 |
|
|
|
1,358 |
|
|
|
1,839 |
|
|
|
|
|
|
|
|
|
|
|
|
Net loss and
comprehensive loss |
|
$ |
(20,320 |
) |
|
$ |
(10,665 |
) |
|
$ |
(47,462 |
) |
|
$ |
(24,336 |
) |
|
|
|
|
|
|
|
|
|
|
|
Net loss per
share, basic and diluted |
|
$ |
(1.72 |
) |
|
$ |
(2.90 |
) |
|
$ |
(5.99 |
) |
|
$ |
(6.62 |
) |
|
|
|
|
|
|
|
|
|
|
|
Weighted-average shares outstanding, basic and diluted |
|
|
11,803,778 |
|
|
|
3,682,897 |
|
|
|
7,926,818 |
|
|
|
3,677,032 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
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(1) Amounts
include stock-based compensation expense as follows: |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Research and
development |
|
$ |
374 |
|
|
$ |
87 |
|
|
$ |
523 |
|
|
$ |
175 |
|
|
General and
administrative |
|
|
915 |
|
|
|
191 |
|
|
|
1,138 |
|
|
|
370 |
|
|
Total stock-based compensation expense |
|
$ |
1,289 |
|
|
$ |
278 |
|
|
$ |
1,661 |
|
|
$ |
545 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
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Vaxcyte,
Inc. |
|
Summary
Consolidated Balance Sheet Data |
|
(in
thousands) |
|
(unaudited) |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
June
30, |
|
December
31, |
|
|
|
|
|
|
|
2020 |
|
|
|
2019 |
|
|
|
|
Cash and
cash equivalents |
|
|
|
$ |
410,046 |
|
|
$ |
58,976 |
|
|
|
|
Total
assets |
|
|
|
|
416,248 |
|
|
|
65,698 |
|
|
|
|
Redeemable
convertible preferred stock |
|
|
|
|
— |
|
|
|
160,310 |
|
|
|
|
Total
stockholders' equity (deficit) |
|
|
|
|
383,210 |
|
|
|
(106,373 |
) |
|
|
|
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