BioNTech Outlines 2024 Strategic Priorities at the 42nd Annual J.P.
Morgan Healthcare Conference
- Plans to have ten or more potentially registrational trials by
the end of 2024
- Preparing to be commercial-ready by the end of 2025
- Ended 2023 with approximately €17.5 billion (unaudited) in
cash, cash equivalents and security investments
- Expects full year 2024 revenues of approximately €3
billion
- Presentation and webcast at the 42nd Annual J.P. Morgan
Healthcare Conference on Tuesday, January 9, 2024, at 6:00 p.m.
CET/ 12:00 p.m. ET
Mainz, Germany, January 9, 2024 (GLOBE
NEWSWIRE) -- BioNTech SE (Nasdaq: BNTX, “BioNTech” or “the
Company”) provided its full year 2024 revenue guidance as part of
its outlined 2024 strategic priorities today at the 42nd Annual
J.P. Morgan Healthcare Conference in San Francisco, California.
“At BioNTech, we are making important strides
towards building a global immunotherapy company. In 2023, we
continued our vaccine leadership in the fight against COVID-19 and
significantly expanded our mid- and late-stage oncology pipeline.
Currently, late-stage trials are ongoing in multiple oncology
indications, and we plan to have ten or more potentially
registrational trials in our pipeline by the end of 2024,”
said Prof. Ugur Sahin, M.D., CEO and Co-Founder of
BioNTech. “This year will be a year of significant
execution at BioNTech as we continue to expand and develop our
innovative pipeline towards our first oncology launches expected
from 2026 onwards.”
Prof. Ugur Sahin, M.D., will present a corporate
overview and update at the 42nd Annual J.P. Morgan Healthcare
Conference on Tuesday, January 9, 2024, at 6:00 p.m. CET/ 12:00
p.m. ET. A live webcast of the presentation will be available on
the “Events & Presentations” page in the Investor Relations
section on the Company’s website. The replay of the webcast will be
archived on the Company’s website for 30 days following the
conference.
2024-2026 Financial
Framework
BioNTech projects total company revenues of
approximately €3 billion for the financial year 2024, mainly driven
by the COVID-19 vaccine franchise which is expected to remain
profitable given the Company’s cost sharing structure with its
partner Pfizer Inc. (“Pfizer”). The Company plans to provide
detailed full year 2024 financial guidance during its Full Year and
Fourth Quarter 2023 Financial Results call on Wednesday, March 20,
2024.
BioNTech ended 2023 with approximately €17.5
billion (unaudited) in cash, cash equivalents and security
investments. The Company plans to maintain a strong financial
position and generate significant interest income in 2024. BioNTech
expects to grow its topline again in 2025. In the outer years, the
Company projects revenues derived from both oncology and
respiratory combination vaccine launches, which are subject to
successful development and regulatory approval.
As a science and innovation driven company,
BioNTech will continue to focus investments on R&D and scaling
the business for commercial readiness in oncology in multiple
countries by the end of 2025 while continuing to be cost
disciplined.
Summary of Selected Pipeline Updates and
Expected Milestones
COVID-19 & Other Infectious
Diseases
BioNTech’s infectious disease portfolio seeks to
address four key areas of high medical need: respiratory viruses,
latent viruses, global health pathogens, and antimicrobials. The
Company has established a broad early-stage infectious disease
vaccine candidate pipeline containing seven clinical programs
leveraging its mRNA technology.
BNT162b2 + BNT161 is an
mRNA-based combination vaccine program against COVID-19 and
influenza being developed in collaboration with Pfizer. Topline
data from the Phase 1/2 trial (NCT05596734) demonstrated robust
immune responses to influenza A, influenza B, and SARS-CoV-2
strains and that the safety profile of the candidates was
consistent with the companies’ COVID-19 vaccine.
Oncology
In 2023, BioNTech made significant progress in
demonstrating the potential of its oncology programs as part of its
in-house discovery and development efforts and added six new
clinical assets, including next generation antibody-drug conjugate
(ADC) candidates and antibody programs, to the Company’s oncology
pipeline through internal and collaborative efforts. The Company’s
pipeline continued to mature in 2023 with various programs
advancing towards later stages of development. BioNTech’s pipeline
currently contains 11 ongoing Phase 2 and 3 trials.
Selected later-stage programs:
BNT323/DB-1303 is an
HER2-targeted antibody-drug conjugate candidate being developed in
collaboration with Duality Biologics (Suzhou) Co. Ltd.
(“DualityBio”). First-in-human data from an ongoing Phase 1/2 trial
(NCT05150691) demonstrated anti-tumor activity in patients with
heavily pretreated HER2-expressing solid tumors. In December 2023,
the U.S. Food and Drug Administration (“FDA”) granted Breakthrough
Designation for BNT323/DB-1303 for the treatment of advanced
endometrial cancer in patients who progressed on or after treatment
with immune checkpoint inhibitors. A pivotal Phase 3 trial
(NCT06018337) in patients with Hormone Receptor-positive (“HR+”)
and HER2-low metastatic breast cancer that have progressed on
hormone and/or cyclin-dependent kinase 4/6 (“CDK4/6”) therapy is
planned. Additional potentially registrational trials are planned
to be initiated in 2024.
BNT316/ONC-392 (gotistobart) is
a next-generation anti-CTLA-4 monoclonal antibody candidate jointly
developed by BioNTech and OncoC4, Inc. (“OncoC4”). A pivotal Phase
3 trial (NCT05671510) evaluating BNT316/ONC-392 (gotistobart) in
patients with immunotherapy-experienced non-small cell lung cancer
(NSCLC) is ongoing.
BNT327/PM8002 (PD-L1xVEGF) is
an anti-VEGF-A antibody candidate fused to a humanized anti-PD-L1
VHH being developed in collaboration with Biotheus Inc.
(“Biotheus”). BNT327/PM8002 is currently being evaluated in several
Phase 2/3 studies in China to assess the efficacy and safety of the
candidate as a monotherapy or in combination with chemotherapy in
various indications. Trial data are planned to be presented this
year at a medical conference, and an Investigational New Drug
application has been accepted by the FDA for further studies in the
U.S. A potentially registrational trial is planned in 2024.
BNT311/GEN1046
(acasunlimab) is a potential first-in-class
bispecific antibody candidate combining PD-L1 checkpoint inhibition
with 4-1BB costimulatory activation being developed in
collaboration with Genmab S/A (“Genmab”). Based on emerging
clinical data, the companies have planned engagement with health
authorities on the design of a Phase 3 trial for BNT311/GEN1046
(acasunlimab) in second line NSCLC. The companies intend to share
the data on which this decision was based at a medical conference
in 2024.
BNT312/GEN1042 is a potential
first-in-class bispecific antibody candidate designed to induce
conditional immune activation by crosslinking CD40 and 4-1BB
positive cells, also being developed in collaboration with Genmab.
Data required to determine next steps for this program are planned
to be shared at a medical conference in 2024.
BNT122 (autogene cevumeran) is
an mRNA cancer vaccine candidate based on an individualized
neoantigen-specific immunotherapy (iNeST) approach being developed
in collaboration with Genentech Inc. (“Genentech”), a member of the
Roche Group. In October 2023, BioNTech announced the initiation of
IMCODE003, a Phase 2 trial (NCT05968326) evaluating the efficacy
and safety of autogene cevumeran in combination with the anti-PD-L1
immune checkpoint inhibitor atezolizumab and standard of care
chemotherapy in patients with resected pancreatic ductal
adenocarcinoma. This is the third indication for which autogene
cevumeran is being evaluated in a Phase 2 trial, alongside other
ongoing studies in first-line melanoma and adjuvant colorectal
cancer. An additional Phase 2 trial is planned to be initiated as
early as late 2024.
BNT211 consists of two
investigational medicinal products: a CAR-T cell product candidate
targeting Claudin-6 (CLDN6)-positive solid tumors, in combination
with a CAR-T cell-amplifying RNA vaccine (CARVac) encoding CLDN6.
BioNTech plans to initiate a pivotal Phase 2 trial in
relapsed/refractory germ cell tumors in 2024.
In 2024, BioNTech intends to accelerate the
development of its portfolio of next-generation investigational
medicines both as monotherapies and in combination with
immunotherapy agents and other targeted therapies across a wide
range of tumor types. BioNTech believes it is well positioned to
have ten or more potentially registrational trials in areas of
unmet medical need by the end of 2024 in advance of launching its
first oncology products from 2026 onwards.
Upcoming Investor and Analyst
Events
- Full Year and Fourth Quarter 2023 Financial Results: March 20,
2024
- Annual General Meeting: May 17, 2024
About BioNTechBiopharmaceutical
New Technologies (BioNTech) is a next generation immunotherapy
company pioneering novel therapies for cancer and other serious
diseases. The Company exploits a wide array of computational
discovery and therapeutic drug platforms for the rapid development
of novel biopharmaceuticals. Its broad portfolio of oncology
product candidates includes individualized and off-the-shelf
mRNA-based therapies, innovative chimeric antigen receptor T cells,
bispecific immune checkpoint modulators, targeted cancer antibodies
and small molecules. Based on its deep expertise in mRNA vaccine
development and in-house manufacturing capabilities, BioNTech is
developing multiple mRNA vaccine candidates for evaluation for a
range of infectious diseases alongside its diverse oncology
pipeline, either on its own or together with collaborators.
BioNTech has established a broad set of relationships with multiple
global pharmaceutical collaborators, including DualityBio, Fosun
Pharma, Genentech, a member of the Roche Group, Genevant, Genmab,
OncoC4, Regeneron and Pfizer.
For more information, please visit
www.BioNTech.com
Forward-Looking StatementsThis
press release contains forward-looking statements within the
meaning of the Private Securities Litigation Reform Act of 1995, as
amended, including, but not limited to, statements concerning:
planned next steps in BioNTech’s pipeline programs, including, but
not limited to, statements regarding timing or plans for initiation
of clinical trials, enrollment or submission for, and receipt of
product approvals with respect to BioNTech’s product candidates;
BioNTech's estimates of certain financial information, including
financial guidance for full year 2024 revenue, which includes
expected revenues related to sales of BioNTech's COVID-19 vaccine
(referred to as COMIRNATY where approved for use under full or
conditional marketing authorization) in territories controlled by
BioNTech's collaboration partners, particularly for those figures
that are derived from preliminary estimates provided by BioNTech's
partners; the rate and degree of market acceptance of BioNTech's
COVID-19 vaccine and, if approved, BioNTech's investigational
medicines; expectations regarding anticipated changes in COVID-19
vaccine demand, including changes to the ordering environment and
expected regulatory recommendations to adapt vaccines to address
new variants or sublineages; the registrational potential of any
trials BioNTech may initiate; the initiation, timing, progress,
results, and cost of BioNTech's research and development programs,
including statements regarding the timing of initiation and
completion of studies or trials and related preparatory work, the
availability of results, and characterization and timing of
clinical data; BioNTech’s targeted timing for a potential oncology
product launch, subject to approval, including expectations
regarding the timing of commercial readiness activities; the
potential safety and efficacy of BioNTech’s product candidates;
BioNTech’s expectations with respect to its intellectual property;
and BioNTech’s ongoing relationships with Pfizer, Inc.; Duality
Biologics (Suzhou) Co. Ltd.; OncoC4, Inc.; Biotheus Inc.; Genmab
S/A; Genentech Inc., a member of the Roche Group; and others. In
some cases, forward-looking statements can be identified by
terminology such as “will,” “may,” “should,” “expects,” “intends,”
“plans,” “aims,” “anticipates,” “believes,” “estimates,”
“predicts,” “potential,” “continue,” or the negative of these terms
or other comparable terminology, although not all forward-looking
statements contain these words. The forward-looking statements in
this press release are neither promises nor guarantees, and you
should not place undue reliance on these forward-looking statements
because they involve known and unknown risks, uncertainties, and
other factors, many of which are beyond BioNTech’s control and
which could cause actual results to differ materially from those
expressed or implied by these forward-looking statements. These
risks and uncertainties include, but are not limited to: the
uncertainties inherent in research and development, including the
ability to meet anticipated clinical endpoints, commencement and/or
completion dates for clinical trials, regulatory submission dates,
regulatory approval dates and/or launch dates, as well as risks
associated with preclinical and clinical data, including the data
discussed in this release, and including the possibility of
unfavorable new preclinical, clinical or safety data and further
analyses of existing preclinical, clinical or safety data; the
nature of the clinical data, which is subject to ongoing peer
review, regulatory review and market interpretation; discussions
with regulatory agencies regarding timing and requirements for
additional clinical trials; the ability to produce comparable
clinical results in future clinical trials; the timing of and
BioNTech's ability to obtain and maintain regulatory approval for
BioNTech's product candidates; the ability of BioNTech’s mRNA
technology to demonstrate clinical efficacy outside of BioNTech’s
infectious disease platform; BioNTech's pricing and coverage
negotiations with governmental authorities, private health insurers
and other third-party payors after BioNTech's initial sales to
national governments; the future commercial demand and medical
need for initial or booster doses of a COVID-19 vaccine;
competition from other COVID-19 vaccines or related to BioNTech's
other product candidates, including those with different mechanisms
of action and different manufacturing and distribution constraints,
on the basis of, among other things, efficacy, cost, convenience of
storage and distribution, breadth of approved use, side-effect
profile and durability of immune response; the ability of
BioNTech’s COVID-19 vaccines to prevent COVID-19 caused by emerging
virus variants; BioNTech's and its counterparties’ ability to
manage and source necessary energy resources; BioNTech's ability to
identify research opportunities and discover and develop
investigational medicines; the ability and willingness of
BioNTech's third-party collaborators to continue research and
development activities relating to BioNTech's development
candidates and investigational medicines; unforeseen safety issues
and potential claims that are alleged to arise from the use of
BioNTech's COVID-19 vaccine and other products and product
candidates developed or manufactured by BioNTech; BioNTech's and
its collaborators’ ability to commercialize and market BioNTech's
COVID-19 vaccine and, if approved, its product candidates;
BioNTech's ability to manage its development and expansion;
regulatory developments in the United States and other countries;
BioNTech's ability to effectively scale BioNTech's production
capabilities and manufacture BioNTech's products, including
BioNTech's target COVID-19 vaccine production levels, and
BioNTech's product candidates; risks relating to the global
financial system and markets; and other factors not known to
BioNTech at this time.
You should review the risks and uncertainties
described under the heading “Risk Factors” in BioNTech's Report on
Form 6-K for the period ended September 30, 2023, and in subsequent
filings made by BioNTech with the SEC, which are available on the
SEC’s website at www.sec.gov. Except as required by law, BioNTech
disclaims any intention or responsibility for updating or revising
any forward-looking statements contained in this press release in
the event of new information, future developments or otherwise.
These forward-looking statements are based on BioNTech’s current
expectations and speak only as of the date hereof.
CONTACTS
Investor RelationsVictoria Meissner, M.D.+1 617
528 8293Investors@biontech.de
Media RelationsJasmina Alatovic+49 (0)6131 9084
1513Media@biontech.de
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