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 first quarter ended March 31,
2024, and provided a business update.
“We continue to make meaningful progress across our business,
including for our pneumococcal conjugate vaccine (PCV) candidates,
VAX-24 and VAX-31, which are intended to deliver the broadest
spectrum of coverage against invasive pneumococcal disease (IPD),”
said Grant Pickering, Chief Executive Officer and Co-founder of
Vaxcyte. “We remain on track to announce the VAX-31 adult Phase 1/2
study topline safety, tolerability and immunogenicity data in the
third quarter of this year, following which we plan to advance
either VAX-24 or VAX-31 into Phase 3 clinical development in
adults. Additionally, with enrollment completed in the VAX-24
infant Phase 2 study, we expect to deliver topline data from the
primary immunization series by the end of the first quarter of
2025. Together, these two milestones will provide significant
insight into our PCV franchise’s ability to achieve its full
potential across the adult and pediatric populations.”
“We closed the first quarter with a strong balance sheet
bolstered by $816.5 million in net proceeds from the follow-on
equity offering in February, propelling advancement of our PCV
franchise and the scale-up of our manufacturing infrastructure,”
said Andrew Guggenhime, President and Chief Financial Officer of
Vaxcyte. “We also continue to progress our early-stage pipeline led
by VAX-A1, a vaccine candidate designed to prevent Group A Strep
infections. We believe our cell-free platform has the potential to
enable the development of first-in-class vaccines to prevent or
treat bacterial infections, which have serious and costly health
consequences when left unchecked.”
Key First Quarter Highlights
PCV Franchise Adult Indication:
- Completed Enrollment of Phase 1/2 Study Evaluating
VAX-31 for the Prevention of IPD in Adults Aged 50 and
Older: In January 2024, Vaxcyte announced the completion
of enrollment in its Phase 1/2 clinical study evaluating VAX-31, a
31-valent PCV candidate designed to prevent IPD, in healthy adults.
This is a randomized, observer-blind, active-controlled,
dose-finding study designed to evaluate the safety, tolerability
and immunogenicity of VAX-31 at three dose levels (low, middle and
high) compared to Prevnar 20® (PCV20) in 1,015 healthy adults aged
50 and older. VAX-31, the broadest-spectrum PCV in the clinic, has
the potential to address a significant public health need by
covering approximately 95% of IPD circulating in the U.S. adult
population while maintaining coverage of previously circulating
strains that are currently contained via ongoing vaccination.
Additional information about the study can be found at
www.clinicaltrials.gov under the identifier NCT06151288.
PCV Franchise Infant Indication:
- Completed Enrollment of Phase 2 Study Evaluating VAX-24
for the Prevention of IPD in Infants: In March 2024,
Vaxcyte announced the completion of enrollment in its Phase 2
clinical study evaluating VAX-24, a broad-spectrum, carrier-sparing
24-valent PCV candidate designed to prevent IPD, in healthy
infants. The Phase 2 clinical study, which enrolled 802
healthy infants, is a randomized, observer-blind, dose-finding
two-stage clinical study evaluating the safety, tolerability and
immunogenicity of VAX-24 in infants. The Stage 1 portion of the
study evaluated the safety and tolerability of a single injection
of VAX-24 at three dose levels (low dose/1.1mcg, middle
dose/2.2mcg, mixed dose/2.2mcg or 4.4mcg) and compared to
VAXNEUVANCE™ (PCV15), which was the broadest-spectrum PCV at the
time of study initiation, in 48 infants. The Stage 2 portion, which
commenced in July 2023, is evaluating the safety, tolerability and
immunogenicity of VAX-24 for the prevention of IPD at the same
three dose levels and compared to PCV20, currently the
broadest-spectrum PCV recommended by the Advisory Committee on
Immunization Practices (ACIP). Participants who received VAX-24 in
Stage 1 will continue the standard dosing regimen as part of Stage
2 and will be included in the safety, tolerability and
immunogenicity analysis of the study. Additional information about
the study can be found at www.clinicaltrials.gov under
the identifier NCT05844423.
Equity Financing:
- Completed Successful $862.5 Million Follow-On
Financing, Further Strengthening Vaxcyte’s Balance Sheet:
In February 2024, Vaxcyte completed an underwritten public offering
of 12,695,312 shares of its common stock, which included the full
exercise of the underwriters’ option to purchase additional shares,
at a public offering price of $64.00 per share and pre-funded
warrants to purchase 781,250 shares of common stock at a public
offering price of $63.999 per underlying share. The aggregate gross
proceeds to Vaxcyte from this offering were $862.5 million, before
deducting underwriting discounts and commissions and other offering
expenses payable by Vaxcyte.
Anticipated Key MilestonesVaxcyte is advancing
the clinical development of its PCV programs with several
anticipated key upcoming milestones:
PCV Franchise Adult Indication:
- Announce topline safety, tolerability and immunogenicity data
from VAX-31 adult Phase 1/2 study in the third quarter of
2024.
- Following VAX-31 data, advance either VAX-24 or VAX-31 to an
adult Phase 3 program.
If VAX-24:
- Initiate Phase 3 pivotal, non-inferiority study in adults aged
50 and older in the second half of 2024 and announce topline
safety, tolerability and immunogenicity data in the second half of
2025.
- Initiate balance of expected Phase 3 studies in 2025 and
2026.
If VAX-31:
- Initiate full complement of expected Phase 3 studies in 2025
and 2026.
PCV Franchise Infant Indication:
- Announce topline safety, tolerability and immunogenicity data
from VAX-24 infant Phase 2 study primary three-dose immunization
series by the end of the first quarter of 2025, followed by topline
data from the booster dose by the end of 2025.
Upcoming May and June Investor Conferences
Company management will participate in fireside chats and host
one-on-one meetings at the following investor conferences, and a
live webcast of the fireside chats will be accessible through the
Investors & Media section of the Company’s website
at http://investors.vaxcyte.com for approximately 30 days
following each conference:
- Bank of America Securities Health Care Conference, May
14-16, 2024: Fireside chat will take place live on
Tuesday, May 14 at 9:20 a.m. PT / 12:20 p.m. ET.
- Jefferies Global Healthcare Conference, June 5-6,
2024: Fireside chat will take place live on Wednesday,
June 5 at 8:30 a.m. PT / 11:30 a.m. ET.
First Quarter 2024 Financial Results
- Cash Position: Cash, cash equivalents and
investments were $1,899.8 million as of March 31, 2024, compared to
$1,242.9 million as of December 31, 2023. The March 31, 2024 amount
includes the $816.5 million in net proceeds from the follow-on
offering completed in February 2024.
- Research & Development (R&D)
Expenses: R&D expenses were $94.6 million for the
three months ended March 31, 2024 as compared to $58.1 million
for the same period in 2023. The increase was due primarily to
higher expenses related to the ongoing VAX-31 adult and VAX-24
infant clinical studies, higher manufacturing expenses related to
the planned VAX-24 or VAX-31 adult Phase 3 clinical trials and the
potential commercial launches of the Company’s PCV programs,
initially in the adult population, as well as an increase in
personnel expenses related to the growth in the number of R&D
employees.
- General & Administrative (G&A)
Expenses: G&A expenses were $19.9 million for the
three months ended March 31, 2024 as compared to $13.1 million
for the same period in 2023. The increase was due primarily to
higher personnel expenses related to the growth in the number of
G&A employees.
- Net Loss: For the three months ended
March 31, 2024, net loss was $95.0 million, compared to $60.5
million for the same period in 2023.
- Commercial Manufacturing Suite: In the first
quarter of 2024, Vaxcyte incurred an additional $15.3 million in
capital and facility buildout expenditures related to the ongoing
construction of the dedicated manufacturing suite at Lonza intended
to support the potential global commercialization of the Company’s
PCV programs. As of March 31, 2024, Vaxcyte had incurred $101.8
million in total capital and facility buildout expenditures that
were reflected on the Company’s balance sheet as of that date.
About Vaxcyte Vaxcyte 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 Phase 3-ready 24-valent, broad-spectrum,
carrier-sparing pneumococcal conjugate vaccine (PCV) being
developed for the prevention of invasive pneumococcal disease
(IPD). VAX-31, the Company’s next-generation 31-valent PCV, is the
broadest-spectrum PCV candidate in the clinic today. Both VAX-24
and VAX-31 are designed to improve upon the standard-of-care PCVs
for both children and adults by covering the serotypes that are
responsible for a significant portion of IPD in circulation and are
associated with high case-fatality rates, antibiotic resistance and
meningitis, while maintaining coverage of previously circulating
strains that are currently contained through continued vaccination
practice.
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 candidate 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, the ability to deliver a potentially first-in-class PCV
franchise and improvement upon the standard-of-care; the process
and timing of anticipated future development of Vaxcyte’s vaccine
candidates; the advancement of either VAX-24 or VAX-31 into a Phase
3 adult clinical program, and the timing of such studies and their
data readouts; the design, timing and availability of data for the
VAX-24 infant Phase 2 study; the design, timing and availability of
data for the VAX-31 adult Phase 1/2 study; the demand for Vaxcyte’s
vaccine candidates; the potential global commercialization of
Vaxcyte’s PCV candidates in both the adult and pediatric
populations; Vaxcyte’s ability to establish global commercial
manufacturing capacity for its PCV candidates; Vaxcyte’s plans to
utilize Lonza infrastructure to support the potential global
commercialization of Vaxcyte’s PCV programs; the ability of
Vaxcyte’s cell-free platform to potentially enable the development
of first-in-class vaccines to prevent or treat bacterial
infections; 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 May 8, 2024 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:
Jennifer Zibuda, Senior Director, Investor RelationsVaxcyte,
Inc.860-729-8902investors@vaxcyte.com
Janet Graesser, Senior Vice President, Corporate Communications
and Investor Relations Vaxcyte,
Inc.917-685-8799media@vaxcyte.com
Vaxcyte,
Inc. |
|
Condensed
Consolidated Statements of Operations |
|
(in
thousands, except share and per share amounts) |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Three Months Ended March 31, |
|
|
|
|
|
|
|
2024 |
|
|
|
2023 |
|
|
|
Operating
expenses: |
|
|
|
|
|
|
|
|
Research and development (1) |
|
|
|
$ |
94,587 |
|
|
$ |
58,080 |
|
|
|
General and administrative (1) |
|
|
|
|
19,885 |
|
|
|
13,112 |
|
|
|
Total operating expenses |
|
|
|
|
114,472 |
|
|
|
71,192 |
|
|
|
|
|
|
|
|
|
|
|
|
Loss from
operations |
|
|
|
|
(114,472 |
) |
|
|
(71,192 |
) |
|
|
Other income
(expense), net: |
|
|
|
|
|
|
|
|
Interest income |
|
|
|
|
21,666 |
|
|
|
10,393 |
|
|
|
Grant income |
|
|
|
|
126 |
|
|
|
654 |
|
|
|
Realized gains on marketable securities |
|
|
|
|
22 |
|
|
|
- |
|
|
|
Foreign currency transaction losses |
|
|
|
|
(2,362 |
) |
|
|
(317 |
) |
|
|
Total other income (expense), net |
|
|
|
|
19,452 |
|
|
|
10,730 |
|
|
|
|
|
|
|
|
|
|
|
|
Net
loss |
|
|
|
$ |
(95,020 |
) |
|
$ |
(60,462 |
) |
|
|
|
|
|
|
|
|
|
|
|
Net loss per
share, basic and diluted |
|
|
|
$ |
(0.85 |
) |
|
$ |
(0.70 |
) |
|
|
|
|
|
|
|
|
|
|
|
Weighted-average shares outstanding, basic and diluted |
|
|
|
111,690,951 |
|
|
|
86,206,817 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
(1) Amounts include
stock-based compensation expense as follows: |
|
|
|
|
|
|
|
|
|
|
|
Research and
development |
|
|
|
$ |
8,818 |
|
|
$ |
4,527 |
|
|
|
General and
administrative |
|
|
|
|
8,811 |
|
|
|
5,121 |
|
|
|
Total stock-based compensation expense |
|
|
|
$ |
17,629 |
|
|
$ |
9,648 |
|
|
|
|
|
|
|
|
|
|
|
|
Vaxcyte,
Inc. |
|
Summary
Consolidated Balance Sheet Data |
|
(in
thousands) |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
March 31, |
|
December
31, |
|
|
|
|
|
|
|
2024 |
|
|
|
2023 |
|
|
|
Cash, cash
equivalents and investments |
|
|
|
$ |
1,899,765 |
|
|
$ |
1,242,902 |
|
|
|
Total
assets |
|
|
|
|
2,091,305 |
|
|
|
1,407,917 |
|
|
|
Total
stockholders' equity |
|
|
|
|
1,983,983 |
|
|
|
1,240,468 |
|
|
|
|
|
|
|
|
|
|
|
|
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