Vaxcyte Reports Third Quarter 2023 Financial Results and Provides Business Update
06 Noviembre 2023 - 3:03PM
Vaxcyte, Inc. (Nasdaq: PCVX), a clinical-stage vaccine innovation
company engineering high-fidelity vaccines to protect humankind
from the consequences of bacterial diseases, today announced
financial results for the third quarter ended September 30, 2023
and provided a business update.
“Vaxcyte has continued to make significant strides toward our
goal of building a best-in-class PCV franchise, including VAX-24
and VAX-31, with the intent of delivering the broadest-spectrum of
coverage against invasive pneumococcal disease,” said Grant
Pickering, Chief Executive Officer and Co-founder of Vaxcyte.
“Following the positive results from the VAX-24 adult Phase 2
clinical studies, we are pleased to have completed a successful
End-of-Phase 2 meeting with the FDA focused on the clinical design
of our Phase 3 program. We look forward to continued interactions
with regulators through the first quarter of next year to finalize
the CMC-related licensure requirements as we prepare to initiate
the VAX-24 adult Phase 3 program, with topline data from the
pivotal, non-inferiority study expected in 2025.”
Mr. Pickering continued, “Additionally, we are excited to
advance VAX-31, which will be the broadest-spectrum PCV to enter
the clinic, into a Phase 1/2 study this quarter following the
recent FDA clearance of the IND application. We expect to announce
topline safety, tolerability and immunogenicity data from this
study in the second half of 2024.”
Key Third Quarter and Recent Highlights
- Completed Successful End-of-Phase 2 Meeting with FDA to
Inform VAX-24 Adult Phase 3 Clinical Program: At the end
of October 2023, Vaxcyte completed a successful End-of-Phase 2
meeting with the U.S. Food and Drug Administration (FDA). The
meeting focused on the VAX-24 adult Phase 3 clinical program,
including the design of the pivotal, non-inferiority study and
other Phase 3 studies needed to support a Biologics License
Application (BLA) submission. Based on the End-of-Phase 2 meeting,
the Company believes there is agreement with the FDA on the
clinical design of the adult Phase 3 program, including the
approximate overall number of subjects, the primary and secondary
endpoints for the pivotal, non-inferiority study as well as
confirmation that the planned immunogenicity analyses are
sufficient to support licensure and an efficacy study is therefore
not required. Vaxcyte plans to provide additional details about the
VAX-24 adult Phase 3 program following additional regulatory
discussions focused on the Company’s chemistry, manufacturing and
controls (CMC) strategy that are expected to occur through the
first quarter of 2024.
- Received FDA Clearance for VAX-31 Adult IND Application
for the Prevention of IPD: In October 2023, Vaxcyte
announced FDA clearance of the VAX-31 Investigational New Drug
(IND) application for the prevention of invasive pneumococcal
disease (IPD) in adults. The VAX-31 Phase 1/2 study, which will
enroll approximately 1,000 adults aged 50 and older, is designed to
enable Vaxcyte to understand the clinical potential of VAX-31 to
improve upon the standard-of-care for adults by providing a
broader-spectrum of protection against IPD. VAX-31 is a 31-valent
pneumococcal conjugate vaccine (PCV) designed to provide coverage
for approximately 95% of IPD currently circulating in the U.S.
adult population.
- Expanded Collaboration with Lonza for Global Commercial
Manufacturing of VAX-24 and VAX-31: In October 2023,
Vaxcyte and Lonza announced a new commercial manufacturing
agreement, which expands the existing collaboration, to support the
potential global commercialization of VAX-24 and VAX-31 in both the
adult and pediatric populations. This agreement builds upon the
long-standing relationship between the companies and complements
Vaxcyte’s plans to utilize existing Lonza infrastructure to advance
clinical development and support the anticipated initial U.S.
launch of VAX-24 for the adult population. Under the terms of the
new agreement, Lonza will provide Vaxcyte with a custom-built
manufacturing suite as part of Lonza’s Ibex® facility in Visp,
Switzerland to support the manufacture of key components, including
the drug substances, for Vaxcyte’s PCV franchise.
- Advanced to Second and Final Stage of Phase 2 Study
Evaluating VAX-24 for the Prevention of IPD in Infants and Dosed
First New Participants: In July 2023, Vaxcyte announced
that the ongoing Phase 2 study of VAX-24 in healthy infants
advanced to the second and final stage of the study. The
independent Data Safety Monitoring Board approved advancing to the
second stage of the study following the review of the safety and
tolerability results from the first stage. New participants began
enrolling and dosing in Stage 2 of the study in July 2023.
Additionally, in agreement with the FDA, Vaxcyte amended the study
protocol for Stage 2, changing the study comparator to Prevnar 20®,
which is currently the broadest-spectrum PCV recommended by the
Advisory Committee on Immunization Practices for infants.
Anticipated Key MilestonesVaxcyte is advancing
the clinical development of its PCV programs with several
anticipated key upcoming milestones, including:
- VAX-24 Adult Program:
- Meetings with the FDA regarding the Company’s CMC strategy to
finalize the Company’s Phase 3 program and BLA requirements
expected to occur through the first quarter of 2024.
- Topline safety, tolerability and immunogenicity data from the
Phase 3 pivotal non-inferiority study in adults in 2025.
- VAX-24 Infant Program:
- Topline safety, tolerability and immunogenicity data from the
primary three-dose immunization series of the infant Phase 2 study
by 2025, followed by topline data from the booster dose
approximately nine months later.
- VAX-31 Adult Program:
- Initiation of the Phase 1/2 study in the fourth quarter of
2023.
- Topline safety, tolerability and immunogenicity data from the
Phase 1/2 study in adults in second half of 2024.
Third Quarter 2023 Financial Results
- Cash Position: Cash, cash equivalents and
investments were $1,434.2 million as of September 30, 2023,
compared to $957.9 million as of December 31, 2022.
- Research & Development (R&D) Expenses:
R&D expenses were $97.4 million for the three months ended
September 30, 2023 as compared to $47.7 million for the same period
in 2022. The increase was due primarily to higher manufacturing
expenses related to the planned VAX-24 Phase 3 clinical trials and
the potential commercial launches of VAX-24 and VAX-31, as well as
an increase in personnel-related expenses related to R&D
growth.
- General & Administrative (G&A)
Expenses: G&A expenses were $15.6 million for the
three months ended September 30, 2023 as compared to $10.9 million
for the same period in 2022. The increase was due primarily to
higher personnel-related expenses related to the growth in G&A
employees as the Company continues to scale.
- Net Loss: For the three months ended September
30, 2023, net loss was $92.7 million, compared to $57.9 million for
the same period in 2022.
About VaxcyteVaxcyte is a vaccine innovation
company engineering high-fidelity vaccines to protect humankind
from the consequences of bacterial diseases. The Company is
developing broad-spectrum conjugate and novel protein vaccines to
prevent or treat bacterial infectious diseases. Vaxcyte’s lead
candidate, VAX-24, is a 24-valent, broad-spectrum, carrier-sparing
PCV being developed for the prevention of IPD and is poised to move
into late-stage development. VAX-31, the only 31-valent PCV in
development, is a follow-on candidate to VAX-24 and part of the
Company’s PCV franchise.
Vaxcyte is re-engineering the way highly complex vaccines are
made through modern synthetic techniques, including advanced
chemistry and the XpressCF™ cell-free protein synthesis platform,
exclusively licensed from Sutro Biopharma, Inc. Unlike conventional
cell-based approaches, the Company’s system for producing
difficult-to-make proteins and antigens is intended to accelerate
its ability to efficiently create and deliver high-fidelity
vaccines with enhanced immunological benefits. Vaxcyte’s pipeline
also includes VAX-A1, a prophylactic vaccine candidate designed to
prevent Group A Strep infections; VAX-PG, a therapeutic vaccine
candidate designed to slow or stop the progression of periodontal
disease; and VAX-GI, a vaccine program designed to prevent
Shigella. Vaxcyte is driven to eradicate or treat invasive
bacterial infections, which have serious and costly health
consequences when left unchecked. For more information, visit
www.vaxcyte.com.
Forward-Looking Statements This 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
potential benefits of VAX-24 and VAX-31, including breadth of
coverage and clinical potential, the ability to deliver a
potentially best-in-class profile and the improvement upon the
standard-of-care; the design, process and timing of anticipated
future development of Vaxcyte’s vaccine candidates, including the
timing and availability of data for the VAX-24 adult and infant
studies and related regulatory interactions and the timing of the
initiation of the VAX-31 adult Phase 1/2 study and availability of
the corresponding topline data; the potential of VAX-31 to serve as
a follow-on candidate to VAX-24; the ability of Vaxcyte to
commercialize VAX-24 and VAX-31; the timing and strategy regarding
the initial commercial launch of VAX-24; the ability of Vaxcyte’s
dedicated manufacturing suite as part of Lonza’s Ibex® facility to
support the manufacture of key components, including the drug
substances; and other statements that are not historical fact. The
words “anticipate,” “believe,” “could,” “expect,” “intend,” “may,”
“on track,” “potential,” “should,” “would” and similar expressions
(as well as other words or expressions referencing future events,
conditions or circumstances) convey uncertainty of future events or
outcomes and 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 November 6, 2023 or in other documents Vaxcyte subsequently
files with or furnishes to the SEC. All forward-looking statements
contained in this press release speak only as of the date on which
they were made and are based on management’s assumptions and
estimates as of such date, and readers should not rely upon the
information in this press release as current or accurate after its
publication date. 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.
Contacts:Janet Graesser, Vice President,
Corporate Communications and Investor Relations Vaxcyte,
Inc.917-685-8799media@vaxcyte.com
Jennifer Zibuda, Senior Director, Investor RelationsVaxcyte,
Inc.860-729-8902investors@vaxcyte.com
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Vaxcyte, Inc. |
|
Condensed Statements of Operations |
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(in thousands, except share and per share
amounts) |
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Three Months Ended September 30, |
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Nine Months Ended September 30, |
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2023 |
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2022 |
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2023 |
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2022 |
|
|
Operating expenses: |
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|
|
|
|
|
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|
|
Research and development (1) |
|
$ |
97,421 |
|
|
$ |
47,679 |
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|
$ |
228,191 |
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|
$ |
117,825 |
|
|
General and administrative (1) |
|
|
15,605 |
|
|
|
10,898 |
|
|
|
43,174 |
|
|
|
27,858 |
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|
Total operating expenses |
|
|
113,026 |
|
|
|
58,577 |
|
|
|
271,365 |
|
|
|
145,683 |
|
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Loss from operations |
|
|
(113,026 |
) |
|
$ |
(58,577 |
) |
|
|
(271,365 |
) |
|
|
(145,683 |
) |
|
Other income (expense), net: |
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Interest expense |
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- |
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|
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- |
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- |
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(2 |
) |
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Interest income |
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|
18,495 |
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|
|
1,190 |
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45,339 |
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|
|
1,723 |
|
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Grant income |
|
|
1,640 |
|
|
|
157 |
|
|
|
4,759 |
|
|
|
1,006 |
|
|
Foreign currency transaction (losses) gains |
|
|
227 |
|
|
|
(687 |
) |
|
|
(198 |
) |
|
|
(2,479 |
) |
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Total other income (expense), net |
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20,362 |
|
|
|
660 |
|
|
|
49,900 |
|
|
|
248 |
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Net loss |
|
$ |
(92,664 |
) |
|
$ |
(57,917 |
) |
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$ |
(221,465 |
) |
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$ |
(145,435 |
) |
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Net loss per share, basic and diluted |
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$ |
(0.91 |
) |
|
$ |
(0.93 |
) |
|
$ |
(2.32 |
) |
|
$ |
(2.42 |
) |
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Weighted-average shares outstanding, basic and diluted |
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101,668,655 |
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61,989,347 |
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95,367,751 |
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60,166,583 |
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(1) Amounts include stock-based compensation expense as
follows: |
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Research and development |
|
$ |
6,335 |
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$ |
2,682 |
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$ |
16,774 |
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|
$ |
6,804 |
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General and administrative |
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|
6,885 |
|
|
|
3,966 |
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|
|
18,639 |
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|
|
9,837 |
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Total stock-based compensation expense |
|
$ |
13,220 |
|
|
$ |
6,648 |
|
|
$ |
35,413 |
|
|
$ |
16,641 |
|
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Vaxcyte, Inc. |
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Summary Balance Sheet Data |
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(in thousands) |
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September 30, |
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December 31, |
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2023 |
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2022 |
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Cash, cash equivalents and investments |
|
|
|
$ |
1,434,248 |
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|
$ |
957,925 |
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Total assets |
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1,496,057 |
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1,006,178 |
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Total stockholders' equity |
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1,402,716 |
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953,613 |
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Vaxcyte (NASDAQ:PCVX)
Gráfica de Acción Histórica
De Ago 2024 a Sep 2024
Vaxcyte (NASDAQ:PCVX)
Gráfica de Acción Histórica
De Sep 2023 a Sep 2024