Merus Announces Financial Results for the Fourth Quarter and Full
Year 2023 and Provides Business Update
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 fourth quarter and full year
and provided a business update.
“2024 is poised to be a transformational year for Merus. For
petosemtamab, we plan to start a phase 3 registration trial in 2L+
HNSCC in mid-2024. In the first-line setting, we plan to provide
initial data on the combination with pembrolizumab in the second
quarter and are preparing for a potential first-line phase 3 trial.
This year, we also plan to evaluate petosemtamab in 2L colorectal
cancer,” said Bill Lundberg, M.D., President, Chief Executive
Officer of Merus. “Additionally, for Zeno we are preparing our
first potential BLA submissions in NRG1+ lung and NRG1+ pancreatic
cancer. We are also excited by continued enhancements to our
productive Multiclonics® platforms, which serve as our engine to
develop innovative antibodies both for our own pipeline and for our
collaborators.”
Petosemtamab (MCLA-158: EGFR x LGR5 Biclonics®): Solid
TumorsPhase 3 registration trial in 2L+ head & neck
squamous cell carcinoma (HNSCC) on track to initiate mid-2024; dose
comparison of petosemtamab monotherapy 1100 vs 1500 mg in
previously treated (2L+) HNSCC ongoing; evaluation in combination
with pembrolizumab as first-line (1L) therapy ongoing; planned
initiation of 2L colorectal cancer (CRC) cohort in 2024
Merus plans to initiate a phase 3 clinical trial in mid-2024 to
evaluate petosemtamab monotherapy in 2L+ 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 evaluate approximately 40 patients treated
with petosemtamab monotherapy at either 1100 or 1500 mg dose levels
to confirm a suitable dose for future potential phase 3
trials. Merus plans to share clinical data from this cohort in
the second half of 2024.
Merus also continues to evaluate patients with untreated
advanced PD-L1+ HNSCC treated with petosemtamab 1500 mg in
combination with pembrolizumab. Initial safety data from this
single arm cohort may support the initiation of a 1L phase 3 trial
with this combination. Among the initial patients dosed in the 1L
combination cohort, the safety profile has been observed to be
generally favorable. Merus plans to report initial interim efficacy
and safety data from this cohort in the second quarter of 2024.
At the American Association of Cancer Research (AACR)
Annual Meeting 2023, Merus provided interim data on 49 2L+ HNSCC
patients that were treated with petosemtamab at the recommended
phase 2 dose of 1500 mg intravenous every two weeks. 43 patients
were evaluable for efficacy. As of a February 1, 2023 data cutoff
date, the ORR was 37.2% by Response Evaluation Criteria in Solid
Tumors (RECIST) v1.1 per investigator assessment. Petosemtamab
continued to demonstrate a manageable safety profile. Merus plans
to provide updated efficacy, durability and safety data of this
cohort in the second half of 2024.
The U.S. Food & Drug Administration (FDA) has
granted Fast Track Designation (FTD) for petosemtamab for the
treatment of patients with recurrent or metastatic HNSCC whose
disease has progressed following treatment with platinum-based
chemotherapy and an anti-programmed cell death protein 1
(anti-PD-1) antibody. FTD is designed to facilitate the development
and expedite the review of drugs to treat serious conditions and
fill unmet medical needs.
In 2024, Merus is planning to initiate the evaluation of
petosemtamab monotherapy in 2L CRC.
Zenocutuzumab (Zeno or MCLA-128: HER2 x HER3
Biclonics®): NRG1 fusion-positive (NRG1+) lung, pancreatic and
other solid tumorsSufficient clinical data expected in
1H24 to support potential BLA submissions in NRG1+ non-small cell
lung cancer (NSCLC) and NRG1+ pancreatic cancer (PDAC)
Zeno is being investigated in the phase 1/2 eNRGy trial and
Early Access Program (EAP) which are assessing the safety and
anti-tumor activity of Zeno monotherapy in NRG1+ cancer.
In 2023, Merus met with the FDA and based on these productive
and collaborative discussions, the Company believes it will have
sufficient clinical data in the first half of 2024 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.
In 2023, the FDA granted Breakthrough Therapy Designation (BTD)
to Zeno for the treatment of patients with advanced unresectable or
metastatic NRG1+ pancreatic cancer following progression with prior
systemic therapy or who have no satisfactory alternative treatment
options. Additionally, the FDA granted BTD to Zeno for the
treatment of patients with advanced unresectable or metastatic
NRG1+ NSCLC, following progression with prior systemic therapy.
Merus shared updated interim clinical data on our Zeno program
(eNRGy trial and EAP) in patients with NRG1+ NSCLC and NRG1+ PDAC
at the European Society for Medical Oncology (ESMO) Congress 2023.
In 78 evaluable NRG1+ NSCLC patients, as of a July 31, 2023 data
cutoff date, a 37% ORR per RECIST v1.1 by investigator assessment
and 14.9 months median duration of response (DOR) was reported. In
33 evaluable NRG1+ PDAC patients, a 42% ORR per RECIST v1.1 by
investigator assessment and 9.1 months median DOR was reported.
Zeno continued to demonstrate a well-tolerated safety profile.
Merus also evaluated patients with castration resistant prostate
cancer (CRPC) treated with Zeno in combination with an androgen
deprivation therapy (enzalutamide or abiraterone), irrespective of
NRG1+ status. Enrollment is complete and Merus plans to continue
monitoring these patients. The Company also continues to monitor
and evaluate patients treated with Zeno in combination with
afatinib but no further enrollment is planned at this time.
The Company is also conducting ongoing translational work on
potential biomarkers outside of NRG1+ cancer which may support
development opportunities for Zeno in additional areas of unmet
need.
MCLA-129 (EGFR x c-MET Biclonics®): Solid
TumorsInvestigation of MCLA-129 continues in the MET ex14
NSCLC expansion cohort in the phase 1/2 trial; MCLA-129 in
combination with chemotherapy in 2L+ EGFR mutant (EGFRm) NSCLC
planned to start in 2024
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 Merus plans to start a cohort of MCLA-129 in
combination with chemotherapy in 2L+ EGFRm NSCLC in 2024.
In December at the ESMO Asia Congress 2023 interim data was
presented on MCLA-129 from ongoing expansion cohorts in NSCLC and
in previously treated HNSCC. Patients with advanced/metastatic
EGFRm NSCLC were treated with MCLA-129 combined with osimertinib as
first-line therapy or in the 2L+ setting after progression on
osimertinib. In the 1L setting, all 16 evaluable patients
experienced tumor shrinkage. In the 2L+ setting, 34 patients were
evaluable for response with 11 experiencing confirmed PRs and 1
unconfirmed PR by RECIST v1.1. per investigator assessment. We
continue to monitor these patients and evaluate potential for
biomarkers to maximize efficacy, while proactively addressing
safety signals seen to date.
We also remain interested in exploring partnering MCLA-129 with
other companies to sufficiently resource the development of
MCLA-129 and potential benefit it may have for patients.
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
TumorsInvestigation continues of the phase 1 trial of
MCLA-145 in combination with pembrolizumab
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, with the
Company monitoring and evaluating patients on treatment with the
combination of MCLA-145 with pembrolizumab.
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 fourth quarter of
2023. 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.
Cash Runway, existing cash, cash equivalents and
marketable securities expected to fund Merus’ operations into
2027As of December 31, 2023, Merus had $411.7
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.
Full Year 2024 Financial ResultsCollaboration
revenue for the year ended December 31, 2023 increased $2.4 million
as compared to the year ended December 31, 2022, primarily as a
result of increases in Incyte revenue of $2.6 million, and Lilly
revenue of $1.0 million, offset by decreases in Other revenue of
$1.2 million. The increase in Incyte revenue is primarily the
result of increases in milestone revenue of $5.0 million and
upfront payment amortization of $0.4 million due to changes in
foreign exchange rates, partially offset by decreases in
reimbursement revenue of $2.8 million. The increase in Lilly
revenue is primarily the result of increases in reimbursement
revenue of $0.7 million and upfront payment amortization of $0.3
million.
Research and development expense for the year ended December 31,
2023 decreased $8.8 million as compared to the year ended December
31, 2022, primarily as a result of decreases in external clinical
services and drug manufacturing costs, including costs to fulfill
our obligations under our collaboration agreements related to our
programs of $18.8 million and partner expenses of $0.7 million,
partially offset by increases to personnel related expenses
including share-based compensation of $6.5 million due to an
increase in employee headcount, consultancy expenses of $2.9
million, facilities expenses of $1.1 million, consumables expenses
of $0.3 million, and travel expenses of $0.3 million.
General and administrative expense for the year ended December
31, 2023 increased $7.6 million as compared to the year ended
December 31, 2022, primarily as a result of increases in
consultancy expenses of $3.1 million, personnel related expenses
including share-base compensation of $2.1 million due to an
increase in employee headcount, intellectual property and licenses
expenses of $1.0 million, facilities and depreciation expense of
$0.9 million, legal expenses of $0.8 million and travel expenses of
$0.5 million, partially offset by decreases in finance and human
resources expenses of $0.9 million.
Other income, net consists of interest earned on our cash and
cash equivalents held on account, accretion of investment earnings
and net foreign exchange gains or losses on our foreign denominated
cash, cash equivalents and marketable securities, and payables and
receivables.
|
MERUS N.V.CONSOLIDATED BALANCE
SHEETS (Amounts in thousands, except share and per
share data) |
|
|
|
2023 |
|
|
2022 |
|
ASSETS |
|
|
|
|
|
|
Current assets: |
|
|
|
|
|
|
Cash and cash equivalents |
|
$ |
204,246 |
|
|
$ |
147,749 |
|
Marketable securities |
|
|
150,130 |
|
|
|
142,480 |
|
Accounts receivable |
|
|
2,429 |
|
|
|
4,051 |
|
Prepaid expenses and other current assets |
|
|
12,009 |
|
|
|
12,163 |
|
Total current assets |
|
|
368,814 |
|
|
|
306,443 |
|
Marketable securities |
|
|
57,312 |
|
|
|
36,457 |
|
Property and equipment,
net |
|
|
12,135 |
|
|
|
12,222 |
|
Operating lease right-of-use
assets |
|
|
11,362 |
|
|
|
12,618 |
|
Intangible assets, net |
|
|
1,800 |
|
|
|
1,950 |
|
Deferred tax assets |
|
|
1,199 |
|
|
|
2,041 |
|
Other assets |
|
|
2,872 |
|
|
|
4,811 |
|
Total assets |
|
$ |
455,494 |
|
|
$ |
376,542 |
|
LIABILITIES AND STOCKHOLDERS’ EQUITY |
|
|
|
|
|
|
Current liabilities: |
|
|
|
|
|
|
Accounts payable |
|
$ |
4,602 |
|
|
$ |
9,834 |
|
Accrued expenses and other liabilities |
|
|
38,482 |
|
|
|
35,590 |
|
Income taxes payable |
|
|
1,646 |
|
|
|
2,400 |
|
Current portion of lease obligation |
|
|
1,674 |
|
|
|
1,684 |
|
Current portion of deferred revenue |
|
|
22,685 |
|
|
|
29,418 |
|
Total current liabilities |
|
|
69,089 |
|
|
|
78,926 |
|
Lease obligation |
|
|
10,488 |
|
|
|
11,790 |
|
Deferred revenue, net of
current portion |
|
|
19,574 |
|
|
|
38,771 |
|
Total liabilities |
|
|
99,151 |
|
|
|
129,487 |
|
Commitments and contingencies
(Note 10) |
|
|
|
|
|
|
Stockholders’ equity: |
|
|
|
|
|
|
Common shares, €0.09 par value; 67,500,000 and 67,500,000 shares
authorized at December 31, 2023 and 2022, respectively; 57,825,879
and 46,310,589 shares issued and outstanding at December 31, 2023
and 2022, respectively |
|
|
5,883 |
|
|
|
4,751 |
|
Additional paid-in capital |
|
|
1,126,054 |
|
|
|
870,874 |
|
Accumulated deficit |
|
|
(753,061 |
) |
|
|
(598,122 |
) |
Accumulated other comprehensive (loss) income |
|
|
(22,533 |
) |
|
|
(30,448 |
) |
Total stockholders’ equity |
|
|
356,343 |
|
|
|
247,055 |
|
Total liabilities and
stockholders’ equity |
|
$ |
455,494 |
|
|
$ |
376,542 |
|
|
MERUS N.V.CONSOLIDATED STATEMENTS OF
OPERATIONS AND COMPREHENSIVE LOSS (Amounts in
thousands, except share and except per share data) |
|
|
|
Year Ended December 31, |
|
|
|
2023 |
|
|
2022 |
|
|
2021 |
|
Collaboration revenue |
|
$ |
43,947 |
|
|
|
41,586 |
|
|
$ |
19,503 |
|
Collaboration revenue (related
party) |
|
|
— |
|
|
|
— |
|
|
|
29,604 |
|
Total revenue |
|
|
43,947 |
|
|
|
41,586 |
|
|
|
49,107 |
|
Operating expenses: |
|
|
|
|
|
|
|
|
|
Research and development |
|
|
140,658 |
|
|
|
149,424 |
|
|
|
98,187 |
|
General and administrative |
|
|
59,836 |
|
|
|
52,200 |
|
|
|
40,896 |
|
Total operating expenses |
|
|
200,494 |
|
|
|
201,624 |
|
|
|
139,083 |
|
|
|
|
|
|
|
|
|
|
|
Operating loss |
|
|
(156,547 |
) |
|
|
(160,038 |
) |
|
|
(89,976 |
) |
Other income (loss), net: |
|
|
|
|
|
|
|
|
|
Interest (expense) income, net |
|
|
14,510 |
|
|
|
2,722 |
|
|
|
(129 |
) |
Foreign exchange (losses) gains, net |
|
|
(9,710 |
) |
|
|
26,022 |
|
|
|
24,663 |
|
Other (losses) gains, net |
|
|
— |
|
|
|
1,059 |
|
|
|
(1,135 |
) |
Total other income (loss), net |
|
|
4,800 |
|
|
|
29,803 |
|
|
|
23,399 |
|
|
|
|
|
|
|
|
|
|
|
Loss before income tax
expense |
|
|
(151,747 |
) |
|
|
(130,235 |
) |
|
|
(66,577 |
) |
Income tax expense |
|
|
3,192 |
|
|
|
959 |
|
|
|
239 |
|
Net loss |
|
$ |
(154,939 |
) |
|
$ |
(131,194 |
) |
|
$ |
(66,816 |
) |
Other comprehensive income
(loss): |
|
|
|
|
|
|
|
|
|
Currency translation adjustment |
|
|
7,915 |
|
|
|
(21,227 |
) |
|
|
(18,292 |
) |
Comprehensive loss |
|
$ |
(147,024 |
) |
|
$ |
(152,421 |
) |
|
$ |
(85,108 |
) |
Net loss per share allocable
to common stockholders: |
|
|
|
|
|
|
|
|
|
Basic and diluted |
|
$ |
(3.00 |
) |
|
$ |
(2.92 |
) |
|
$ |
(1.73 |
) |
Weighted-average common shares
outstanding: |
|
|
|
|
|
|
|
|
|
Basic and diluted |
|
|
51,605,444 |
|
|
|
44,919,084 |
|
|
|
38,638,434 |
|
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, and LinkedIn.
Forward-Looking StatementsThis 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; our
belief that 2024 is poised to be a transformational year for Merus;
our plan to start a phase 3 registration trial in 2L+ HNSCC in
mid-2024; our plan to provide initial interim efficacy and safety
data on the combination with pembrolizumab in the second quarter of
2024; our preparation for a potential first-line phase 3 trial of
petosemtamab in combination with pembrolizumab in untreated
advanced PD-L1+ HNSCC; our plan to initiate investigation of
petosemtamab in 2L colorectal cancer patients; our preparing for
potential BLA submissions for Zeno in the treatment of NRG1+ PDAC
and NRG1+ NSCLC; the continued enhancements to our productive
Multiclonics® platforms, which serve as our engine to develop
innovative antibodies both for our own pipeline and for our
collaborators; our 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; the potential design and details of our planned phase 3
trial investigating monotherapy petosemtamab in 2L 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 and plan to
share the clinical data form this cohort in the second half of
2024; our plan to provide updated efficacy, durability and safety
data in the second half of 2024 of the cohort disclosed at the AACR
Annual Meeting 2023; our plan to initiate a cohort investigating
petosemtamab in 2L colorectal cancer; 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
continued monitoring and evaluation of patients with CRPC receiving
Zeno in combination with ADT, and patients with NRG1+ NSCLC
receiving Zeno in combination with afatinib; our conduct of ongoing
translational work on potential biomarkers outside of NRG1+ tumors,
which may support development opportunities for Zeno in additional
areas of unmet need; statements regarding the sufficiency of our
cash, cash equivalents and marketable securities, and expectation
that it will fund the Company into 2027; the ongoing monitoring and
evaluation of patients the phase 1 trial of MCLA-145 in combination
with pembrolizumab; the advancement of the phase 1/2 trial for
MCLA-129 in the dose expansion phase, in monotherapy in Met ex14
NSCLC; the ongoing monitoring and evaluation of patients receiving
MCLA-129 in combination with osimertinib; our plan to initiate a
cohort of MCLA-129 in combination with chemotherapy in 2L+ EGFRm
NSCLC in 2024; 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, 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.
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