BioNTech SE (NASDAQ: BNTX, “BioNTech” or “the Company”), a
clinical-stage biotechnology company focused patient-specific
immunotherapies for the treatment of cancer and other serious
diseases, today provided an update on its corporate progress and
reported financial results for the quarter ended September 30,
2019.
“In the third quarter, we achieved important
milestones in our ambition to become the leading global
biotechnology company for individualized cancer medicine,” said
Prof. Ugur Sahin, BioNTech’s CEO. “In addition to
our successful IPO, we are also pleased with the advancement of our
programs. We initiated the second first-in-human clinical trial in
our 50:50 collaboration program with Genmab and successfully
transferred the IND for BNT321 from MabVax to BioNTech. Our balance
sheet remains strong and we are looking forward to advancing the
development of our planned clinical development program and growth
plans. We plan to initiate up to six first-in-human clinical trials
by the end of 2020.”
___________________________1 ECB exchange rate on September 30th
was 1.0889.
Key Pipeline Updates
Below is a summary of our clinical product candidates, organized
by platform.
Oncology
FixVac: Our FixVac product
candidates contain selected combinations of pharmacologically
optimized uridine mRNA encoding known cancer-specific shared
antigens.
- BNT111 (advanced melanoma): We
expect to initiate both a Phase 2 trial and a registrational,
randomized Phase 3 trial for BNT111 in 2020.
- BNT112 (prostate cancer): We plan
to initiate a Phase 1/2 trial for BNT112 targeting prostate cancer
in the second half of 2019. In the third quarter of 2019, CTAs were
approved in various European countries to support the initiation of
this trial.
- BNT113 (HPV+ head and neck
cancers): We are planning to initiate a Phase 2 trial for BNT113 in
HPV+ head and neck cancers by the second half of 2020.
- BNT114 (triple negative breast
cancer): We are conducting a Phase 1 trial of BNT114 in triple
negative breast cancer and expect to report a data update in the
first half of 2020.
Individualized neoantigen specific
immunotherapy (iNeST): Our iNeST immunotherapies contain
unmodified, pharmacologically-optimized mRNA encoding up to 20
patient-specific neoantigens and also feature our proprietary
RNA-LPX formulation. We are conducting, in collaboration with
Genentech, clinical trials of our iNeST product candidate,
RO7198457 (BNT122). We and Genentech expect to provide a data
update from our RO7198457 (BNT122) Phase 1 trial in multiple solid
tumors in 2020 and expect to report topline interim data from our
RO7198457 (BNT122) Phase 2 trial in first-line melanoma in the
second half of 2020.
mRNA intratumoral
immunotherapy: In collaboration with Sanofi, we are
conducting a Phase 1/2 trial of SAR441000 (BNT131), our first
mRNA-based intratumoral immunotherapy, as a monotherapy or in
combination with cemiplimab in patients with solid tumors. We plan
to provide an update on this trial in the second half of 2020.
CLDN6 CAR-T cell immunotherapy:
We are developing a proprietary chimeric antigen receptor T cell,
or CAR T, product candidate, BNT211, targeting Claudin-6, or CLDN6,
a novel solid tumor-specific antigen. We expect to initiate a Phase
1/2 clinical trial for BNT211 in patients with advanced CLDN6 +
solid tumors in the first half of 2020.
Next-generation checkpoint
immunomodulators: We are developing, in collaboration with
Genmab, novel bispecific antibodies that are designed for
conditional activation of immunostimulatory checkpoint molecules.
Our first bispecific candidates are GEN1046 (BNT311), which targets
PD-L1 in conjunction with 4-1BB, and GEN1042 (BNT312), which
targets CD40 in conjunction with 4-1BB. Genmab has initiated a
Phase 1/2a trial for each of GEN1046 (BNT311) and GEN1042 (BNT312)
in solid tumors.
GEN1042 (BNT312) is a bispecific antibody
designed to enhance an anti-tumor immune response through
conditional CD40-mediated stimulation of antigen presenting cells
crosslinked with conditional stimulation of 4-1BB+ T cells. We and
Genmab began enrollment in August 2019 for a Phase 1/2a trial of
BNT312 for the treatment of malignant solid tumors, including
non-small cell lung cancer, colorectal cancer and melanoma. The
first patient in this study was dosed in September 2019.
In the preclinical setting, GEN1042 (BNT312)
activated antigen presenting cells and enhanced T cell activation,
and also resulted in the conditional activation and expansion of
previously activated CD8+ T cells and cytokines. The ongoing Phase
1/2a trial has an estimated enrollment of 126 participants and is
an open-label, multi-center safety trial of GEN1042 (BNT312)
administered intravenously every 21 days. The trial consists of a
dose escalation phase and an expansion phase which will be
initiated once the recommended Phase 2 dose has been determined.
GEN1042 (BNT312) is one of two bispecific antibodies currently in
clinical trials by Genmab and BioNTech as part of a 50:50 strategic
collaboration in which development costs and future profit are
shared. BioNTech and Genmab shall jointly commercialize GEN1042
(BNT312) as to be further defined in a commercialization agreement
between the parties.
Targeted cancer antibodies:
BNT321 (MVT-5873) is a fully human IgG1 monoclonal antibody
targeting sialyl Lewis A (sLea), a novel epitope expressed
specifically in pancreatic and other solid tumors. BNT321
(MVT-5873) is currently in Phase 1 clinical development in
pancreatic cancer. We have filed the updated protocol and
supporting regulatory documentation with the FDA to transfer the
IND for MVT-5873 to BioNTech and resume the clinical trial
following the acquisition of the assets of MabVax Therapeutics
Holdings, Inc. and MabVax Therapeutics, Inc. in May 2019. The IND
transfer of MVT-5873 to BioNTech was successfully achieved in
August 2019. We expect the trial to be re-initiated in the fourth
quarter of 2019 and anticipate resuming patient enrollment in the
fourth quarter. This will be the first BioNTech-sponsored study
conducted in the US under an IND.
BNT321 is a fully human IgG1 monoclonal antibody
targeting sialyl Lewis A or CA19-9, an epitope expressed in
pancreatic and other gastrointestinal cancers that plays a role in
tumor adhesion and metastasis formation and is a marker of an
aggressive cancer phenotype.
In a Phase 1 dose-escalating study, 12
pancreatic cancer patients with CA19-9 positive metastatic
malignancies were injected with MVT-2163, a radiolabelled PET
imaging version of BNT321. A significant portion of patients
demonstrated high uptake of BNT321 in tumor tissue, suggesting that
the PET imaging high-affinity antibody version of BNT321 may be
used as a theranostic tool for the sensitive detection of primary
tumors and metastatic disease. BNT321 may also have potential to
deliver therapeutic doses of radiation to cancer cells.
BNT321 has also been investigated as a naked
antibody in an open-label, multi-center, non-randomized dose
escalation Phase 1/2 trial evaluating the safety and recommended
Phase 2 dose both as a monotherapy or in combination with a
standard of care chemotherapy. In this cohort, BNT321 was given in
combination with nab-paclitaxel and gemcitabine to six patients
newly diagnosed with CA19-9+ pancreatic cancer. At a dose of
0.125mg/kg, BNT321 was generally well tolerated by all patients
when added to first line chemotherapy. All six patients evaluated
had measurable tumor reductions by RECIST criteria, with four
patients meeting the criteria for partial response and two patients
meeting the criteria for stable disease.
BioNTech intends to further evaluate BNT321 in
CA19-9+ tumors, including in advanced pancreatic cancer and expects
to resume the Phase 1/2 trial in the fourth quarter of 2019.
Small molecule
immunomodulators: BNT411 is our novel small molecule TLR7
agonist product candidate. BNT411 is engineered for high potency
and high selectivity for the TLR7 receptor to activate both the
adaptive and innate immune system. BNT411 will be given as a
monotherapy or in combination with chemotherapy and/or checkpoint
inhibitors in multiple solid tumors, including colorectal cancer,
bladder cancer and small cell lung cancer. We filed an IND with the
FDA in early November 2019 and expect to initiate a Phase 1/2a
clinical trial of BNT411 in the first half of 2020.
In preclinical studies, BNT411 induced a strong
type-1 Interferon-dominated release of cytokines and a potent
stimulation of antigen-specific CD8+ T cells, B cells, and innate
immune cells such as NK cells and macrophages, resulting in potent
anti-tumor activity in various mouse models.
Recent Corporate
Developments
Clinical trial supply agreement with
Regeneron: In November 2019, BioNTech signed a clinical
trial supply agreement with Regeneron to supply cemiplimab for use
in combination with BioNTech’s BNT112 in a first-in-human Phase 1/2
trial in advanced prostate cancer. Under the terms of the
agreement, BioNTech and Regeneron will agree to a joint clinical
development plan in prostate cancer and Regeneron will agree to
supply their PD-1 checkpoint inhibitor Libtayo® (cemiplimab) at no
cost to BioNTech for use in combination with BNT112 in BioNTech’s
planned Phase 1/2 trial. BioNTech and Regeneron will each retain
full commercial rights to BNT112 and Libtayo respectively.
BioNTech will be the sponsor of the trial. The CTA in various
European countries was accepted on November 5, 2019. BioNTech
expects to initiate the single-agent dose escalation part of the
Phase 1/2 trial in the fourth quarter of 2019.
Exercise of Greenshoe:On
October 29, 2019, JP Morgan Securities LLC, BOFA Securities, Inc,
UBS Securities LLC and SVB Leerink LLC, as representatives of the
lead joint book-running managers of BioNTech’s recently closed
initial public offering on the Nasdaq Global Market, exercised
their over-allotment option to purchase an additional 517,408
American Depository Shares (“ADSs”) at a price to the public of
US$15 per ADS, representing 517,408 ordinary shares with no par
value with a notional amount attributable to each ordinary share of
€1 each. The option exercise closed on November 6, 2019 and raised
additional net proceeds of approximately $7 million (€6,6 million),
after deducting underwriting discounts and commissions.
Third Quarter 2019 Financial
Results
Cash Position: Cash and cash
equivalents as of September 30, 2019, were €463.3 million, compared
to €411.5 million as of December 31, 2018.
Revenue: Total revenue,
consisting primarily of revenue from collaborative agreements, was
€28.7 million for the quarter ended September 30, 2019, compared to
€20.4 million for the quarter ended September 30, 2018. The
increase was primarily due to progress in our collaboration
agreements with Genentech and Eli Lilly.
Research and Development
Expenses: Research and development expenses were €50.4
million for the quarter ended September 30, 2019, compared to €32.8
million for the quarter ended September 30, 2018. The increase was
primarily due to an increase in headcount, the expense recognized
from the granting of options under the ESOP program and higher
expenses regarding our collaboration agreements.
General and Administrative
Expenses: General and administrative expenses were €10.6
million for the quarter ended September 30, 2019, compared to €6.6
million for the quarter ended September 30, 2018. This increase was
primarily due to an increase in headcount and the expense
recognized from the granting of options under the ESOP program.
Net Loss: Net loss was €30.1
million for the quarter ended September 30, 2019, compared to net
loss of €23.5 million for the quarter ended September 30, 2018.
Shares Outstanding: Shares
outstanding as of September 30, 2019 were 216,262,336.
Full financial statements can be found in the
6-K filing as published on the SEC website under
https://www.sec.gov/.
Conference Call and Webcast
Information
BioNTech SE will host a conference call and
webcast today at 08:00 a.m. ET (2:00 p.m. CET) to report its
financial results for the third quarter ended September 30, 2019
and provide a corporate update.
To participate in the conference call, please
dial the following numbers five minutes prior to the start of the
call and provide the Conference ID: 8453733.
United States international: +1 631
510 7495United States domestic (toll-free): +1 866 966
1396Germany: +49 692 443 7351
Participants may also access the slides and the
webcast of the conference call via the “Events & Presentations”
page of the Investor Relations section of the Company’s website at
https://biontech.de/. A replay of the webcast will be available
shortly after the conclusion of the call and archived on the
Company’s website for 30 days following the call.
About BioNTech
BioNTech was founded in 2008 on the
understanding that every cancer patient’s tumor is unique and
therefore each patient’s treatment should be individualized. Its
cutting-edge pipeline includes individualized mRNA-based product
candidates, innovative chimeric antigen receptor T cells, novel
checkpoint immunomodulators, targeted cancer antibodies and small
molecules. BioNTech has established relationships with seven
pharmaceutical collaborators, including Eli Lilly and Company,
Genmab, Sanofi, Bayer Animal Health, Genentech, a member of the
Roche Group, Genevant and Pfizer, and has published over 150
peer-reviewed publications on its scientific approach.
Forward-Looking Statements
This 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: the planned next steps in BioNTech’s
pipeline programs and specifically including, but not limited to,
statements regarding the re-initiation of clinical trials for
BNT321; plans to initiate clinical trials of BNT111, BNT112, BNT113
and BNT211; and expectations for data announcements with respect to
BioNTech’s iNeST and BNT114 clinical trials. 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. You should review the risks and
uncertainties described under the heading “Risk Factors” and those
described in BioNTech’s Prospectus filed with the U.S.
Securities and Exchange Commission (SEC) on October
11, 2019 and in subsequent filings made
by BioNTech with the SEC, which are available on
the SEC’s website at https://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.
For more information, please
contact:
BioNTech
SE
Michael Boehler, MD, Head of Global External
CommunicationsTel: +49 (0)6131 9084 1640Email:
Michael.Boehler@biontech.de
For all media inquiries:
Trophic Communications Gretchen Schweitzer /
Stephanie May, PhD Tel: +49 (0)89 23 88 77 30 or +49 171 185 56
82Email: May@trophic.eu
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