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 fourth quarter and full year ended
December 31, 2023, and provided a business update.
“Over the past year, we made significant progress across
clinical, regulatory and manufacturing with our broad-spectrum,
carrier-sparing pneumococcal conjugate vaccine (PCV) franchise,
comprising VAX-24 and VAX-31, which are designed to prevent
invasive pneumococcal disease (IPD) in adults and children. These
notable achievements, coupled with two follow-on equity financings
totaling approximately $1.4 billion in gross proceeds, fortified
our efforts to build what we believe is a best-in-class PCV
franchise,” said Grant Pickering, Chief Executive Officer and
Co-founder of Vaxcyte. “This year promises an important anticipated
milestone with the VAX-31 adult Phase 1/2 topline data expected in
the third quarter, following which we intend to advance either
VAX-24 or VAX-31 into a Phase 3 adult clinical program.
Additionally, enrollment in the VAX-24 infant Phase 2 study is
nearing completion, and we remain on track to announce Phase 2
topline data from the primary immunization series by the end of the
first quarter of 2025.”
“The follow-on equity offering completed earlier this month
generated approximately $816.5 million in net proceeds, further
strengthening our balance sheet to advance our PCV franchise,
including Phase 3 studies and manufacturing scale-up, along with
our early-stage vaccine candidates while also growing the
organization in support of these initiatives,” said Andrew
Guggenhime, President and Chief Financial Officer of Vaxcyte. “We
look forward to delivering multiple anticipated Phase 3 data
readouts over the next few years as we progress toward a Biologics
License Application (BLA) submission for either the VAX-24 or
VAX-31 adult program.”
Key 2023 and 2024 to Date 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. Additional information about the study can be found
at www.clinicaltrials.gov under the identifier NCT06151288.
- Completed End-of-Phase 2 Meeting with FDA and Held CMC
Regulatory Discussions; VAX-24 Adult Clinical Program is Phase
3-Ready: In 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 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. Additionally, as
part of ongoing Chemistry, Manufacturing and Controls (CMC)-focused
discussions, Vaxcyte received encouraging input from the FDA
regarding the VAX-24 adult licensure requirements. The Company was
granted these discussions under the VAX-24 adult Breakthrough
Therapy designation and expects to seek additional CMC-focused
input from the FDA as it continues to prepare for and potentially
conduct the VAX-24 adult Phase 3 program.
- Reported Positive Data from Phase 2 Study of VAX-24 in
Adults Aged 65 and Older and Full Six-Month Safety Data from Adult
Phase 1/2 and Phase 2 Studies: In April 2023, Vaxcyte
announced positive results from the VAX-24 Phase 2 study in adults
aged 65 and older, as well as data from the full six-month safety
assessment and prespecified pooled immunogenicity analyses from
both the Phase 2 study in adults aged 65 and older and the prior
Phase 1/2 proof-of-concept (POC) study in adults aged 18-64 (Phase
1 portion included adults aged 18-49, Phase 2 portion included
adults aged 50-64). In the Phase 2 study in adults aged 65 and
older, VAX-24 demonstrated robust opsonophagocytic activity (OPA)
immune responses for all 24 serotypes at all doses studied,
confirming the prior adult Phase 1/2 POC study results. The
six-month safety data from both studies showed safety and
tolerability results for VAX-24 similar to PCV20 at all doses
studied.
- VAX-24 Adult Phase 1/2 POC Data Published in The Lancet
Infectious Diseases Highlighting Best-in-Class Potential of
VAX-24: In December 2023, the results from the VAX-24
Phase 1/2 clinical POC study were published in the journal The
Lancet Infectious Diseases.
- VAX-24 Granted Breakthrough Therapy Designation from
the FDA for the Prevention of IPD in Adults Aged 18 and
Older: In January 2023, Vaxcyte announced
that the FDA granted Breakthrough Therapy designation for VAX-24
for the prevention of IPD in adults. With Breakthrough Therapy
designation, Vaxcyte has access to all of the elements of the FDA’s
Fast Track program, as well as the ability to receive guidance and
support from the FDA on an efficient drug development program and
an organizational commitment from senior managers within the FDA.
The Breakthrough Therapy designation process is designed to
expedite the development and review of drugs and biologics that are
intended to treat a serious or life-threatening condition, where
preliminary clinical evidence indicates that the drug or biologic
may demonstrate substantial improvement over existing therapies on
one or more clinically significant endpoints.
PCV Franchise Infant Indication:
- Enrollment in VAX-24 Infant Phase 2 Study Nearing
Completion: The VAX-24 infant Phase 2 study is nearing
enrollment completion. This is a randomized, observer-blind,
dose-finding two-stage clinical study evaluating the safety,
tolerability and immunogenicity of VAX-24 in healthy 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) 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, in approximately 750 infants. Additional
information about the study can be found at www.clinicaltrials.gov
under the identifier NCT05844423.
Global Manufacturing:
- Exercised Option and Entered into Manufacturing Rights
Agreement with Sutro Biopharma, Inc. (Sutro) to Obtain Control Over
Manufacturing and Development of Cell-Free Extract for Vaxcyte’s
Vaccine Candidates: In November 2023, Vaxcyte exercised
its option and entered into a manufacturing rights agreement with
Sutro to obtain control over the development and manufacture of
cell-free extract, a key component of Vaxcyte’s PCV candidates.
Pursuant to the manufacturing rights agreement, Vaxcyte obtained
exclusive rights to independently, or through certain third
parties, develop, improve and manufacture cell-free extract for use
in connection with the Company’s vaccine candidates.
- Expanded Collaboration with Lonza for Global Commercial
Manufacturing of Vaxcyte’s PCV Candidates: In October
2023, Vaxcyte and Lonza entered into a new commercial manufacturing
agreement, expanding the existing collaboration. This agreement
supports the potential global commercialization of Vaxcyte’s PCV
candidates in both the adult and pediatric populations 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 or VAX-31 for the adult
population.
Equity Financings:
- Completed Two Successful Follow-On Financings Totaling
Approximately $1.4 Billion in Gross Proceeds, 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
approximately $862.5 million, before deducting underwriting
discounts and commissions and other offering expenses payable by
Vaxcyte.
- In April 2023, Vaxcyte completed an underwritten public
offering of 13,030,000 shares of its common stock, which included
the full exercise of the underwriters’ option to purchase
additional shares, at a public offering price of $41.00 per share
and pre-funded warrants to purchase 1,000,000 shares of common
stock at a public offering price of $40.999 per underlying share.
The aggregate gross proceeds to Vaxcyte from the offering were
approximately $575.2 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 in the third quarter, 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 March Investor Conferences
Company management will participate in fireside chats and host
one-on-one meetings at the following investor conferences. 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.
- Cowen 44th Annual
Health Care Conference, March 4-6, 2024:
Fireside Chat will take place live on Tuesday, March 5 at 2:10 p.m.
ET.
- Leerink Global Biopharma Conference, March 11-13,
2024: Fireside Chat will take place live on Tuesday, March
12 at 8:40 a.m. ET.
- Jefferies Biotech on the Bay Summit, March 11-13,
2024: One-on-one investor meetings will be held on
Wednesday, March 13.
Fourth Quarter and Full Year 2023 Financial
Results
- Cash Position: Cash, cash equivalents and
investments were $1,242.9 million as of December 31, 2023, compared
to $957.9 million as of December 31, 2022. The December 31, 2023
balance excludes approximately $816.5 million in net proceeds from
the Company’s underwritten public offering completed in February
2024.
- Research & Development (R&D) Expenses:
R&D expenses were $104.1 million for the three months ended
December 31, 2023 and $332.3 million for the full year 2023 as
compared to $51.6 million and $169.5 million, respectively, for the
same periods in 2022. The increase for the year ended December 31,
2023 was due primarily to higher manufacturing expenses related to
the planned adult Phase 3 clinical trials and the potential
commercial launches of the Company’s PCV programs, as well as an
increase in personnel expenses related to the growth in R&D
employees.
- Acquired Manufacturing Rights: Acquired
manufacturing rights expenses of $75.0 million for the three months
and full year ended December 31, 2023 related to the exercise of
the option with Sutro Biopharma, of which $50.0 million was paid in
cash in the fourth quarter of 2023. Acquired manufacturing rights
expenses of $23.0 million for the three months and full year ended
December 31, 2022 related to the upfront consideration incurred in
connection with the original option agreement entered into with
Sutro Biopharma.
- General & Administrative (G&A)
Expenses: G&A expenses were $17.5 million for the
three months ended December 31, 2023 and $60.7 million for the
full year 2023 as compared to $12.0 million and $39.8 million,
respectively, for the same periods in 2022. The increase for the
year ended December 31, 2023 was due primarily to higher personnel
expenses related to the growth in G&A employees.
- Net Loss: For the three months and year ended
December 31, 2023, net loss was $180.8 million and $402.3
million, respectively, compared to $78.1 million and $223.5 million
for the same periods in 2022.
- Commercial Manufacturing Suite: In the fourth
quarter of 2023, construction and buildout commenced on the
manufacturing suite to support the potential global
commercialization of Vaxcyte’s PCV programs in connection with the
commercial manufacturing agreement Vaxcyte entered into with Lonza
in October 2023. As of December 31, 2023, Vaxcyte had incurred
$86.5 million of capital and facility buildout expenditures that
were reflected on the Company’s consolidated balance sheet as of
that date.
Conference Call and WebcastVaxcyte will host a
conference call and webcast to discuss this announcement today,
February 27, 2024, at 4:30 p.m. ET / 1:30 p.m. PT. To participate
in the conference call, please dial 800-225-9448 (domestic) or
203-518-9708 (international) and refer to conference ID PCVXQ423. A
live webcast of the conference call will be available in the
Investors & Media section of the Company’s website at
www.vaxcyte.com. After the live webcast, the event will remain
archived on Vaxcyte’s website for 30 days.
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 PCV being developed for the prevention of 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 best-in-class PCV
franchise and the 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
timing of a potential BLA submission for VAX-24 or VAX-31; 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 existing Lonza infrastructure to advance clinical
development and support the anticipated initial U.S. launch of
VAX-24 or VAX-31 for the adult population; 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 Annual
Report on Form 10-K filed with the SEC on February 27, 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:
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
Vaxcyte,
Inc. |
Condensed
Statements of Operations |
(in
thousands, except share and per share amounts) |
|
|
|
|
|
|
|
|
|
Year Ended
December 31, |
|
|
|
2023 |
|
|
|
2022 |
|
|
|
2021 |
|
Operating
expenses: |
|
|
|
|
|
|
Research and development (1) |
|
$ |
332,341 |
|
|
$ |
169,451 |
|
|
$ |
78,411 |
|
Acquired manufacturing rights |
|
|
75,000 |
|
|
|
22,995 |
|
|
|
- |
|
General and administrative (1) |
|
|
60,700 |
|
|
|
39,810 |
|
|
|
25,259 |
|
Total operating expenses |
|
|
468,041 |
|
|
|
232,256 |
|
|
|
103,670 |
|
|
|
|
|
|
|
|
Loss from
operations |
|
|
(468,041 |
) |
|
|
(232,256 |
) |
|
|
(103,670 |
) |
Other income
(expense), net |
|
|
|
|
|
|
Interest expense |
|
|
- |
|
|
|
(2 |
) |
|
|
(7 |
) |
Interest income |
|
|
62,907 |
|
|
|
8,356 |
|
|
|
344 |
|
Grant income |
|
|
4,765 |
|
|
|
1,931 |
|
|
|
1,585 |
|
Realized gains on marketable securities |
|
|
- |
|
|
|
- |
|
|
|
2 |
|
Loss on disposal of fixed assets |
|
|
- |
|
|
|
(44 |
) |
|
|
- |
|
Foreign currency transaction (losses) gains |
|
|
(1,897 |
) |
|
|
(1,470 |
) |
|
|
1,669 |
|
Total other income (expense), net |
|
|
65,775 |
|
|
|
8,771 |
|
|
|
3,593 |
|
|
|
|
|
|
|
|
Net
loss |
|
$ |
(402,266 |
) |
|
$ |
(223,485 |
) |
|
$ |
(100,077 |
) |
|
|
|
|
|
|
|
Net loss per
share, basic and diluted |
|
$ |
(4.14 |
) |
|
$ |
(3.44 |
) |
|
$ |
(1.93 |
) |
|
|
|
|
|
|
|
Weighted-average shares outstanding, basic and diluted |
|
97,157,690 |
|
|
|
64,877,988 |
|
|
|
51,922,108 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
(1) Amounts include
stock-based compensation expense as follows: |
|
|
|
|
|
|
|
Research and
development |
|
$ |
23,275 |
|
|
$ |
9,899 |
|
|
$ |
3,954 |
|
General and
administrative |
|
|
25,485 |
|
|
|
13,751 |
|
|
|
6,775 |
|
Total stock-based compensation expense |
|
$ |
48,760 |
|
|
$ |
23,650 |
|
|
$ |
10,729 |
|
|
|
|
|
|
|
|
Vaxcyte,
Inc. |
Summary
Balance Sheet Data |
(in
thousands) |
|
|
|
|
|
|
|
|
|
|
|
December 31, |
|
|
|
|
|
2023 |
|
|
|
2022 |
|
Cash, cash
equivalents and investments |
|
|
|
$ |
1,242,902 |
|
|
$ |
957,925 |
|
Total
assets |
|
|
|
|
1,407,917 |
|
|
|
1,006,178 |
|
Total
stockholders' equity |
|
|
|
|
1,240,468 |
|
|
|
953,613 |
|
|
|
|
|
|
|
|
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