Merus N.V. (Nasdaq: MRUS) (Merus, the Company, we, or our), a
clinical-stage oncology company developing innovative, full-length
multispecific antibodies (Biclonics® and Triclonics®), today
announced financial results for the third quarter and provided a
business update.
“The next several quarters are key for Merus and we are focused
on execution of our clinical programs, particularly Zeno and
petosemtamab,” said Bill Lundberg, M.D., President, Chief
Executive Officer of Merus. “For Zeno, our most advanced clinical
candidate, we are looking forward to potential BLA submissions- our
first as a company. For petosemtamab, we are preparing for a phase
3 study in 2L+ expected to start mid-2024. In the front line
setting we plan to provide initial data on the combination with
Keytruda in the 1H24. We are preparing for a potential front line
registration trial, with our decision conditioned on the safety
profile being confirmed. We believe petosemtamab has the potential
to become a new standard of care for HNSCC.”
Petosemtamab (MCLA-158: EGFR x LGR5 Biclonics®): Solid
TumorsGranted Fast Track Designation (FTD) for the
treatment of patients with recurrent or metastatic head & neck
squamous cell carcinoma (HNSCC); enrollment continues in dose
comparison of petosemtamab monotherapy 1100 vs 1500 mg in
previously treated HNSCC, as well as in combination with
Keytruda® (pembrolizumab) as front-line therapy
Merus plans to initiate a phase 3 clinical trial in mid-2024 to
evaluate petosemtamab monotherapy in previously treated recurrent
or metastatic HNSCC. In the planned trial, patients will be
randomized to petosemtamab monotherapy or investigators’ choice of
single agent chemotherapy or cetuximab. Merus believes a randomized
registration trial in HNSCC with an overall response rate (ORR)
endpoint could potentially support accelerated approval and the
overall survival (OS) results from the same study could potentially
verify its clinical benefit to support regular approval.
Merus continues to enroll approximately 40 patients with
previously treated HNSCC with petosemtamab monotherapy at the 1100
or 1500 mg dose levels to confirm a suitable dose for future
potential randomized trials. Merus plans to share the clinical
data from this cohort in 2024.
Merus also continues to enroll patients with previously
untreated advanced PD-L1+ HNSCC with petosemtamab 1500 mg in
combination with Keytruda®. Initial safety data from this single
arm cohort may support the initiation of a first-line registration
trial with this combination. Among the initial patients dosed in
the front-line combination, the safety profile has been observed to
be generally favorable. Merus plans to report initial interim
safety and efficacy data from this cohort in the first half of
2024.
Zenocutuzumab (Zeno or MCLA-128: HER2 x HER3
Biclonics®): NRG1 fusion-positive (NRG1+) cancer and other solid
tumorsGranted Breakthrough Therapy Designations (BTDs) for
both NRG1+ non-small cell lung cancer (NSCLC) and NRG1+ pancreatic
cancer (PDAC); the eNRGy trial of Zeno monotherapy in NRG1+ cancer
and a phase 2 trial of Zeno in combination with androgen
deprivation therapy (ADT) in castration resistant prostate cancer
(CRPC) continues; as well as in combination with afatinib in NRG1+
NSCLC
We shared updated interim clinical data on our Zeno program
(eNRGy trial and Early Access Program (EAP)) in patients with NRG1+
NSCLC and PDAC at the European Society for Medical Oncology (ESMO)
Congress 2023.
The reported data are from the phase 1/2 eNRGy trial and EAP
which are assessing the safety and anti-tumor activity of Zeno
monotherapy in NRG1+ cancer.
Durable efficacy of zenocutuzumab, a HER2 x HER3
bispecific antibody, in advanced NRG1
fusion-positive (NRG1+) non-small cell lung cancer
(NSCLC) Observations in the presentation
include:
- As of July 31, 2023 data cutoff
date, 105 patients with NRG1+ NSCLC were treated with Zeno. 78
patients with measurable disease were treated by February 13, 2023,
allowing for the potential for ≥ 24 weeks follow-up, and who met
the criteria for the primary analysis population.
- 37.2% (29/78; 95% Cl: 26.5-48.9)
overall response rate (ORR) per RECIST (Response Evaluation
Criteria in Solid Tumors) v1.1 by investigator assessment
- 61.5% (95% CI: 49.8 - 72.3) clinical
benefit rate (CBR)
- 14.9 months (95% CI: 7.4-20.4)
median duration of response (DOR) and 20 patients were continuing
treatment as of the data cutoff
Durable efficacy of zenocutuzumab, a HER2 x HER3
bispecific antibody, in advanced NRG1
fusion-positive (NRG1+) pancreatic ductal
adenocarcinoma
(PDAC) Observations in
the presentation include:
- As of July 31, 2023 data cutoff
date, 44 patients with NRG1+ PDAC were treated with Zeno. 33
patients with measurable disease were treated by February 13, 2023,
allowing for the potential for ≥ 24 weeks follow-up, and who met
the criteria for the primary analysis population.
- 42.4% (95% CI, 25.5–60.8) ORR
per RECIST v1.1 by investigator assessment; 1 (3%) patient achieved
a complete response, and 13 (39%) patients achieved a partial
response
- 72.7% (95% CI, 54-87) CBR
- 82% experienced tumor
reduction
- Of 27 evaluable patients for CA
19-9 values, 21 (78%) showed a ≥ 50% decrease in CA 19-9 values
from baseline
- 9.1 months (95% CI, 5.5–12.0)
median DOR; and 6 patients were continuing treatment as of the data
cutoff
Safety findings from both
presentations: Zeno demonstrated a well tolerated
safety profile among the 189 NRG1+ cancer patients who were treated
at the cutoff date with 750 mg Q2W monotherapy, with only 6% of
patients experiencing related grade 3-4 toxicities.
An encore poster presentation will take place at ESMO Asia
Congress 2023 in Singapore December 1-3, 2023.
Presentation Details:
Title: Durable efficacy of zenocutuzumab, a
HER2 x HER3 bispecific antibody, in advanced NRG1 fusion-positive
(NRG1+) non-small cell lung cancer (NSCLC)Session
Category: Poster sessionDate: Saturday,
December 2, 2023 Time: 17:50-18:45 p.m.
SGTPresentation #: 595P
Merus recently met with the U.S. Food & Drug Administration
(FDA) in the context of our two Break Through Designations and
based on these productive and collaborative discussions, we believe
we will have sufficient clinical data in 1H24 to support potential
Biologics License Application (BLA) submissions in NRG1+ NSCLC and
NRG1+ PDAC.
Merus believes that obtaining a commercialization partnership
agreement will be an essential step in bringing Zeno to patients
with NRG1+ cancer, if approved.
Zeno in combination with ADT in CRPC Merus is
also evaluating Zeno in combination with an ADT (enzalutamide or
abiraterone) in CRPC, irrespective of NRG1+ status. As of a data
cutoff date of September 12, 2023, 10 patients have been treated,
ranging in age from 55-86 years, with a median of three lines of
prior therapy, and a median of 16.4 weeks of Zeno exposure, with
three patients remaining on treatment as of the data cutoff date.
The combination of Zeno and ADT was generally well tolerated with
no treatment related AEs of grade 3 or higher. The range of
maximum PSA change from baseline was +300% to -35%. Seven patients
discontinued for disease progression. Three patients remained on
treatment as of the cutoff date and continue to be followed for
efficacy and safety. The best overall response by PCWG3-modified
RECIST v1.1 by CT and/or bone scan in 9 evaluable patients at the
time of data cutoff is stable disease in 7 patients and progressive
disease in 2 patients. One patient was excluded from the efficacy
population due to less than two cycles of Zeno treatment.
Merus plans to continue monitoring these patients and evaluating
these data to determine potential further exploration of this
indication. The company is also conducting ongoing translational
work on potential biomarkers outside of NRG1+ tumors, in CRPC and
beyond which may support development opportunities for Zeno in
additional areas of unmet need.
MCLA-129 (EGFR x c-MET Biclonics®): Solid
TumorsEnrollment continues in the expansion cohorts in the
phase 1/2 trial; clinical update planned at ESMO Asia 2023
MCLA-129 is in clinical development in a phase 1/2, open-label
clinical trial evaluating MCLA-129 monotherapy in patients with MET
ex14 NSCLC and in HNSCC, as well as MCLA-129 in combination with
Tagrisso®, a third generation EGFR TKI, in patients with
treatment-naïve EGFR mutant (m) NSCLC and in patients with EGFRm
NSCLC that have progressed on Tagrisso®.
Merus has discontinued the NSCLC with EGFR exon20 mutation
cohort due to the competition in this niche market.
Abstracts on the bispecific antibody MCLA-129 as first line
therapy for, and in previously treated, NSCLC and in previously
treated HNSCC, were selected for presentation at the ESMO Asia
Congress 2023.
Presentation Details:
Title: Efficacy and safety of MCLA-129, an
EGFR x c-MET bispecific antibody, combined with osimertinib, as
first-line therapy or after progression on osimertinib in non-small
cell lung cancer (NSCLC)Session Category:
Mini-oral session 2Session: Thoracic
CancerDate: Sunday, December 3, 2023
Time: 9:40 -9:45 a.m. SGTPresentation
#: 516MO
Title: Efficacy and safety of MCLA-129, an
anti-EGFR/c-MET bispecific antibody, in head and neck squamous cell
cancer (HNSCC)Session Category: Poster
sessionDate: Saturday, December 2, 2023
Time: 17:50-18:45 p.m. SGTPresentation
#: 362P
MCLA-129 is subject to a collaboration and license agreement
with Betta Pharmaceuticals Co. Ltd. (Betta), which permits Betta to
develop MCLA-129 and potentially commercialize exclusively
in China, while Merus retains global rights outside
of China.
MCLA-145 (CD137 x PD-L1 Biclonics®): Solid
TumorsThe phase 1 trial continues in combination with
Keytruda® (pembrolizumab), a PD-1 inhibitor
MCLA-145 is in clinical development in a global, phase 1,
open-label, clinical trial evaluating MCLA-145 in patients with
solid tumors. The trial is in the dose expansion phase evaluating
the combination of MCLA-145 with Keytruda®.
Collaborations
Incyte CorporationSince 2017, Merus has been
working with Incyte Corporation (Incyte) under a global
collaboration and license agreement focused on the research,
discovery and development of bispecific antibodies utilizing Merus’
proprietary Biclonics® technology platform. The agreement
grants Incyte certain exclusive rights for up to ten bispecific and
monospecific antibody programs. The collaboration is progressing,
with multiple programs in various stages of preclinical and
clinical development. For each program under the collaboration,
Merus receives reimbursement for research activities and is
eligible to receive potential development, regulatory and
commercial milestones and sales royalties for any products, if
approved. Further, Incyte announced, in 2023, that INCA33890, a
novel TGFBr2xPD-1 bispecific antibody developed through the
collaboration is currently being evaluated in clinical trials.
Merus achieved a milestone and received a payment of $2.5
million related to the advancement of this program in the
third quarter of 2023. Merus also achieved an additional milestone
of $1 million for candidate nomination in the quarter. This is the
third program to undergo candidate nomination under the
collaboration.
Loxo Oncology at LillyIn January
2021, Merus and Loxo Oncology at Lilly, a research
and development group of Eli Lilly and Company (Lilly), announced a
research collaboration and exclusive license agreement to develop
up to three CD3-engaging T-cell re-directing bispecific antibody
therapies utilizing Merus’ Biclonics® platform and proprietary
CD3 panel along with the scientific and rational drug design
expertise of Loxo Oncology at Lilly. The collaboration is
progressing with multiple active research programs underway.
Corporate ActivitiesCompleted public offering
raising $172M gross proceedsIn August 2023, Merus closed a
public offering, with gross proceeds from the offering of
approximately $172 million, inclusive of underwriters’ 30-day
option to purchase additional common shares at the public offering
price. Net proceeds from the offering are planned to be used to
advance the clinical development of our product candidates, for
preclinical research and technology development, and for working
capital and general corporate purposes.
Cash Runway, existing cash, cash equivalents and
marketable securities expected to fund Merus’ operations into
2027As of September 30, 2023, Merus had $446
million cash, cash equivalents and marketable securities.
Based on the Company’s current operating plan, the existing cash,
cash equivalents and marketable securities are expected to fund
Merus’ operations into 2027.
Third Quarter 2023 Financial
ResultsCollaboration revenue for the three months
ended September 30, 2023 increased by $4.4
million as compared to the three months
ended September 30, 2022, primarily as a result of
earning milestones of $3.5 million from Incyte. The change in
exchange rates did not significantly impact collaboration
revenue.
Research and development expense for the three months
ended September 30, 2023 decreased by $5.5
million as compared to the three months
ended September 30, 2022, primarily as a result of a
decrease in external clinical services and drug manufacturing
costs.
General and administrative expense for the three months
ended September 30, 2023 was flat as compared
to the three months ended September 30, 2022.
Collaboration revenue for the nine months
ended September 30, 2023 increased by $4.1
million as compared to the nine months
ended September 30, 2022, primarily due to $3.5 million
in milestones earned from Incyte.
Research and development expense for the nine months
ended September 30, 2023 decreased by $0.4
million as compared to the nine months
ended September 30, 2022, primarily as a result of a
decrease in external clinical services and drug manufacturing
costs.
General and administrative expense for the nine months
ended September 30, 2023 increased by $7.1
million as compared to the nine months
ended September 30, 2022, primarily as a result of an
increase in stock-based compensation expense, personnel related
expenses, and consultancy costs.
Other income (loss), net consists of interest earned and fees
paid on our cash and cash equivalents held on account, accretion of
investment earnings and net foreign exchange (losses) gains on our
foreign denominated cash, cash equivalents and marketable
securities. Other gains or losses relate to the issuance and
settlement of financial instruments.
MERUS N.V. |
CONDENSED CONSOLIDATED BALANCE SHEETS |
(UNAUDITED) |
(Amounts in thousands, except share and per share
data) |
|
|
September 30,2023 |
|
|
December 31,2022 |
|
ASSETS |
|
|
|
|
|
Current assets: |
|
|
|
|
|
Cash and cash equivalents |
$ |
241,868 |
|
|
$ |
147,749 |
|
Marketable securities |
|
146,702 |
|
|
|
142,480 |
|
Accounts receivable |
|
3,434 |
|
|
|
4,051 |
|
Prepaid expenses and other current assets |
|
12,828 |
|
|
|
12,163 |
|
Total current assets |
|
404,832 |
|
|
|
306,443 |
|
Marketable securities |
|
57,259 |
|
|
|
36,457 |
|
Property and equipment, net |
|
12,176 |
|
|
|
12,222 |
|
Operating lease right-of-use
assets |
|
11,323 |
|
|
|
12,618 |
|
Intangible assets, net |
|
1,771 |
|
|
|
1,950 |
|
Deferred tax assets |
|
702 |
|
|
|
2,041 |
|
Other assets |
|
4,123 |
|
|
|
4,811 |
|
Total assets |
$ |
492,186 |
|
|
$ |
376,542 |
|
LIABILITIES AND STOCKHOLDERS’ EQUITY |
|
|
|
|
|
Current liabilities: |
|
|
|
|
|
Accounts payable |
$ |
3,843 |
|
|
$ |
9,834 |
|
Accrued expenses and other liabilities |
|
35,712 |
|
|
|
35,590 |
|
Income taxes payable |
|
137 |
|
|
|
2,400 |
|
Current portion of lease obligation |
|
1,607 |
|
|
|
1,684 |
|
Current portion of deferred revenue |
|
23,019 |
|
|
|
29,418 |
|
Total current liabilities |
|
64,318 |
|
|
|
78,926 |
|
Lease obligation |
|
10,506 |
|
|
|
11,790 |
|
Deferred revenue, net of current
portion |
|
23,974 |
|
|
|
38,771 |
|
Total liabilities |
|
98,798 |
|
|
|
129,487 |
|
Commitments and contingencies -
Note 6 |
|
|
|
|
|
Stockholders’ equity: |
|
|
|
|
|
Common shares, €0.09 par value; 67,500,000 shares authorized at
September 30, 2023 and December 31, 2022; 57,729,180 and 46,310,589
shares issued and outstanding as at September 30, 2023 and
December 31, 2022, respectively |
|
5,874 |
|
|
|
4,751 |
|
Additional paid-in capital |
|
1,117,855 |
|
|
|
870,874 |
|
Accumulated other comprehensive income |
|
(37,433 |
) |
|
|
(30,448 |
) |
Accumulated deficit |
|
(692,908 |
) |
|
|
(598,122 |
) |
Total stockholders’ equity |
|
393,388 |
|
|
|
247,055 |
|
Total liabilities and
stockholders’ equity |
$ |
492,186 |
|
|
$ |
376,542 |
|
MERUS N.V. |
CONDENSED CONSOLIDATED STATEMENTS OF OPERATIONS AND
COMPREHENSIVE LOSS |
(UNAUDITED) |
(Amounts in thousands, except share and per share
data) |
|
Three Months
EndedSeptember 30, |
|
|
Nine Months
EndedSeptember 30, |
|
|
2023 |
|
|
2022 |
|
|
2023 |
|
|
2022 |
|
Collaboration revenue |
$ |
11,033 |
|
|
$ |
6,581 |
|
|
$ |
35,008 |
|
|
$ |
30,920 |
|
Total revenue |
|
11,033 |
|
|
|
6,581 |
|
|
|
35,008 |
|
|
|
30,920 |
|
Operating expenses: |
|
|
|
|
|
|
|
|
|
|
|
Research and development |
|
36,810 |
|
|
|
42,307 |
|
|
|
99,973 |
|
|
|
100,378 |
|
General and administrative |
|
12,591 |
|
|
|
12,469 |
|
|
|
44,040 |
|
|
|
36,917 |
|
Total operating expenses |
|
49,401 |
|
|
|
54,776 |
|
|
|
144,013 |
|
|
|
137,295 |
|
Operating loss |
|
(38,368 |
) |
|
|
(48,195 |
) |
|
|
(109,005 |
) |
|
|
(106,375 |
) |
Other income, net: |
|
|
|
|
|
|
|
|
|
|
|
Interest income, net |
|
4,522 |
|
|
|
866 |
|
|
|
9,312 |
|
|
|
1,288 |
|
Foreign exchange gains (loss) |
|
11,952 |
|
|
|
23,041 |
|
|
|
7,062 |
|
|
|
55,378 |
|
Other gains, net |
|
— |
|
|
|
— |
|
|
|
— |
|
|
|
1,059 |
|
Total other income (loss),
net |
|
16,474 |
|
|
|
23,907 |
|
|
|
16,374 |
|
|
|
57,725 |
|
|
|
|
|
|
|
|
|
|
|
|
|
Net loss before income taxes |
|
(21,894 |
) |
|
|
(24,288 |
) |
|
|
(92,631 |
) |
|
|
(48,650 |
) |
Income tax expense |
|
1,118 |
|
|
|
327 |
|
|
|
2,155 |
|
|
|
572 |
|
Net loss |
$ |
(23,012 |
) |
|
$ |
(24,615 |
) |
|
$ |
(94,786 |
) |
|
$ |
(49,222 |
) |
Other comprehensive loss: |
|
|
|
|
|
|
|
|
|
|
|
Currency translation adjustment |
|
(10,722 |
) |
|
|
(19,475 |
) |
|
|
(6,985 |
) |
|
|
(45,444 |
) |
Comprehensive loss |
$ |
(33,734 |
) |
|
$ |
(44,090 |
) |
|
$ |
(101,771 |
) |
|
$ |
(94,666 |
) |
Net loss per share attributable
to common stockholders: |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Basic and diluted |
$ |
(0.43 |
) |
|
$ |
(0.53 |
) |
|
$ |
(1.91 |
) |
|
$ |
(1.11 |
) |
Weighted-average common shares
outstanding: |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Basic and diluted |
|
53,869,762 |
|
|
|
46,056,719 |
|
|
|
49,532,722 |
|
|
|
44,451,997 |
|
About Merus N.V.
Merus is a clinical-stage oncology company developing innovative
full-length human bispecific and trispecific antibody therapeutics,
referred to as Multiclonics®. Multiclonics® are manufactured using
industry standard processes and have been observed in preclinical
and clinical studies to have several of the same features of
conventional human monoclonal antibodies, such as long half-life
and low immunogenicity. For additional information, please visit
Merus’ website, Twitter and LinkedIn.
Forward-Looking Statements
This press release contains forward-looking statements within
the meaning of the Private Securities Litigation Reform Act of
1995. All statements contained in this press release that do not
relate to matters of historical fact should be considered
forward-looking statements, including without limitation,
statements regarding the content and timing of clinical trials,
data readouts and clinical, regulatory, strategy and development
updates for our product candidates; Merus belief that the next
several quarters are key for the Company, our focus on execution of
our clinical programs, particularly Zeno and petosemtamab; our
looking forward to potential BLA submissions and belief that we
expect to have data in the 1H of 2024 in NRG1+ NSCLC and NRG1+ PDAC
for potential BLA submissions; our preparation for a phase 3 study
in 2L + expected to start mid-2024; our plan to provide initial
data on the combination with Keytruda in the 1H24; our preparation
for a potential front line registration trial investigating
petosemtamab in combination with Keytruda in previously untreated
advanced PD-L1+ HNSCC, with our decision conditioned on the safety
profile of the combination of Keytruda and petosemtamab; our belief
that petosemtamab has the potential to become a new standard of
care for HNSCC; the potential design and details of our planned
phase 3 trial design, potentially initiating a randomized phase 3
trial of petosemtamab monotherapy, or investigators’ choice of
single agent chemotherapy or cetuximab in 2L/3L HNSCC; the
enrollment of approximately 40 patients in previously treated HNSCC
with petosemtamab monotherapy at the 1100 or 1500 mg dose levels to
confirm a suitable dose for future randomized trials; the potential
benefits of FTD for petosemtamab and BTD designations for Zeno and
the ability of Merus to maintain such designations; our belief that
obtaining a commercialization partnership agreement will be an
essential step in bringing Zeno to patients with NRG1+ cancer, if
approved; our data on patients with CRPC receiving Zeno in
combination with ADT, and the impact of such data and our plan to
continue monitoring these patients and evaluating these data to
determine potential further exploration of this indication; our
conduct of ongoing translational work on potential biomarkers
outside of NRG1+ tumors, in CRPC and beyond which may support
development opportunities for Zeno in additional areas of unmet
need; the planned presentations of Zeno and MCLA-129 at ESMO Asia
2023; statements regarding the sufficiency of our cash, cash
equivalents and marketable securities, and expectation that it will
fund the Company into 2027; our planned use of proceeds from the
follow-on offering that raised gross proceeds of
approximately $172 million; the advancement of the phase 1
trial of MCLA-145 in combination with Keytruda®; the advancement of
the phase 1/2 trial for MCLA-129 in the dose expansion phase, in
monotherapy in Met ex14 NSCLC, in HNSCC, as well as in combination
with Tagrisso® in treatment naïve EGFRm NSCLC and in patients with
EGFRm NSCLC that have progressed on Tagrisso®; the design and
treatment potential of our bispecific antibody candidates and
impact of their preclinical data; the benefits of the collaboration
between Loxo Oncology at Lilly and Merus, its potential for future
value generation, including whether and when Merus will receive any
future payment under the collaboration, including milestones or
royalties, and the amounts of such payments; whether any programs
under the collaboration will be successful; Merus’ and Lilly’s
activities under the agreement; our global collaboration and
license agreement with Incyte, its progress and potential
development and commercialization of up to ten bispecific and
monospecific antibodies from our Biclonics® platform and Incyte’s
clinical study of INCA33890 developed in collaboration with us,
including whether and when Merus will receive any future payment
under the collaboration, including milestones or royalties, and the
amounts of such payments; whether any programs under the
collaboration will be successful; and our collaboration and license
agreement with Betta, which permits Betta to develop MCLA-129 and
potentially commercialize exclusively in China, while Merus retains
full ex-China rights, including any future clinical development by
Betta of MCLA-129. These forward-looking statements are based on
management’s current expectations. These statements are neither
promises nor guarantees, but involve known and unknown risks,
uncertainties and other important factors that may cause our actual
results, performance or achievements to be materially different
from any future results, performance or achievements expressed or
implied by the forward-looking statements, including, but not
limited to, the following: our need for additional funding, which
may not be available and which may require us to restrict our
operations or require us to relinquish rights to our technologies
or antibody candidates; potential delays in regulatory approval,
which would impact our ability to commercialize our product
candidates and affect our ability to generate revenue; the lengthy
and expensive process of clinical drug development, which has an
uncertain outcome; the unpredictable nature of our early stage
development efforts for marketable drugs; potential delays in
enrollment of patients, which could affect the receipt of necessary
regulatory approvals; our reliance on third parties to conduct our
clinical trials and the potential for those third parties to not
perform satisfactorily; impacts of the COVID-19 pandemic; we may
not identify suitable Biclonics® or bispecific antibody candidates
under our collaborations or our collaborators may fail to perform
adequately under our collaborations; our reliance on third parties
to manufacture our product candidates, which may delay, prevent or
impair our development and commercialization efforts; protection of
our proprietary technology; our patents may be found invalid,
unenforceable, circumvented by competitors and our patent
applications may be found not to comply with the rules and
regulations of patentability; we may fail to prevail in potential
lawsuits for infringement of third-party intellectual property; our
registered or unregistered trademarks or trade names may be
challenged, infringed, circumvented or declared generic or
determined to be infringing on other marks; and risks related to
our ceasing to qualify as an emerging growth company and a smaller
reporting company after December 31, 2021.
These and other important factors discussed under the caption
“Risk Factors” in our Annual Report on Form 10-Q for the period
ended September 30, 2023, filed with the Securities and Exchange
Commission, or SEC, on November 2, 2023, and our other reports
filed with the SEC, could cause actual results to differ materially
from those indicated by the forward-looking statements made in this
press release. Any such forward-looking statements represent
management’s estimates as of the date of this press release. While
we may elect to update such forward-looking statements at some
point in the future, we disclaim any obligation to do so, even if
subsequent events cause our views to change, except as required
under applicable law. These forward-looking statements should not
be relied upon as representing our views as of any date subsequent
to the date of this press release.
Multiclonics®, Biclonics® and Triclonics® are registered
trademarks of Merus N.V.
Investor and Media Inquiries:
Sherri Spear
Merus N.V.
VP Investor Relations and Corporate Communications
617-821-3246
s.spear@merus.nl
Kathleen Farren
Merus N.V.
Investor Relations and Corporate Communications
617-230-4165
k.farren@merus.nl
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