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 first quarter and provided a
business update.
“We were thrilled to share the robust interim clinical results
for petosemtamab, our first in class bispecific antibody targeting
EGFR and LGR5 in patients with previously treated head and neck
squamous cell carcinoma at AACR,” said Bill Lundberg, M.D.,
President, Chief Executive Officer of Merus. “We are advancing our
petosemtamab program diligently toward a registration-directed
study in head and neck cancer. We expect our strong cash position
to continue to fund the company meaningfully beyond several
near-term clinical milestones and program updates, and into the
second half of 2025.”
Petosemtamab (MCLA-158: EGFR x LGR5 Biclonics®): Solid
TumorsEnrollment continues in dose expansion in the phase
1/2 trial, including in combination with Keytruda
(pembrolizumab)
Petosemtamab is in clinical development in the expansion part of
a phase 1/2 open-label, multicenter trial in advanced solid tumors,
including previously treated head and neck squamous cell carcinoma
(HNSCC). The Company also initiated a cohort investigating
petosemtamab in combination with Keytruda in patients with
untreated HNSCC, designed to evaluate safety and clinical activity
in this population.
In April, Merus provided an interim clinical update at the AACR
Annual Meeting 2023. As of the February 1, 2023 data cutoff date,
49 previously treated HNSCC patients (pts) were treated with
petosemtamab at the recommended phase 2 dose of 1500 mg intravenous
every two weeks. Patients had experienced a median of 2 (range 1-4)
prior lines of systemic therapy including PD-(L)1 inhibitor in 96%
of pts, chemotherapy in 94% and platinum-based chemotherapy in 92%
of pts; 2 pts received prior cetuximab. 43 pts were evaluable for
efficacy, receiving ≥2 treatment cycles (≥8 weeks) with ≥1
post-baseline tumor assessment or experiencing early progressive
disease. The overall response rate was 37.2% (16/43; 95% CI
23%-53.3%) by RECIST 1.1. per investigator assessment, including 15
confirmed partial responses and 1 confirmed complete response
(ongoing after 20 months). Median duration of response was 6.0
months (95% CI 3.7-NC), with 10 of 16 (62.5%) responders ongoing at
the time of the data cutoff. Median progression free survival was
5.3 months (95% CI 3.7-6.8); with 29 of 43 pts progressing and 14
of 43 pts censored. Median overall survival was 11.5 months (95% CI
7.2-20.6); with 29 of 49 pts still alive at the data cutoff date.
Petosemtamab continued to demonstrate a manageable safety
profile.
Merus met with the U.S. Food and Drug Administration (FDA) in an
end-of-phase meeting to discuss interim results from the previously
treated HNSCC cohort of the petosemtamab phase 1/2 trial. The FDA
recognized recurrent or metastatic HNSCC represents an area of
unmet medical need, and provided clear recommendations for the path
to potential registration.
Based on the strong clinical data and discussions with the FDA,
Merus believes a randomized clinical trial in previously treated
(2L/3L) or untreated (front-line) HNSCC may support a possible
registration. Additionally, Merus believes a randomized
registration trial in HNSCC with an overall response rate endpoint
could potentially support accelerated approval and the overall
survival results from the same study could potentially verify its
clinical benefit to support regular approval. The Company plans to
continue to acquire data to confirm a suitable dose for future
randomized clinical trials. Merus plans to provide an update in Q3
2023 on the potential registrational path for this program.
Zenocutuzumab (Zeno or MCLA-128: HER2 x HER3
Biclonics®): NRG1+ cancer and other solid tumorsEnrollment
continues in 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), and in combination with afatinib in NRG1+ non-small cell
lung cancer (NSCLC)
Merus plans to provide an update on the potential registrational
path and timeline in NRG1+ cancer in the first half of 2023 and a
clinical update on Zeno in NRG1+ cancer at a major medical
conference in 2023.
Further, Merus is evaluating Zeno in combination with an ADT
(enzalutamide or abiraterone) in men with CRPC, irrespective of
NRG1+ status. Merus plans to provide initial clinical data on Zeno
in CRPC in the second half of 2023.
Merus is also evaluating Zeno in combination with afatinib in
patients with NRG1+ NSCLC.
MCLA-129 (EGFR x c-MET Biclonics®): Solid
TumorsEnrollment continues in the expansion cohorts in the
phase 1/2 trial; clinical update planned for 2H23
MCLA-129 is in clinical development in a phase 1/2, open-label
clinical trial evaluating MCLA-129 monotherapy in patients with
EGFR ex20 NSCLC, MET ex14 NSCLC, and in HNSCC, as well as MCLA-129
in combination with Tagrisso (osimertinib), 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.
In April, Merus provided a pre-clinical presentation of MCLA-129
in comparison with amivantamab at the AACR Annual Meeting 2023. The
Company plans to provide an initial clinical data update from the
expansion cohorts, and a further clinical development strategy
update in the second half of 2023.
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
TumorsEnrollment continues in the phase 1 trial including
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 consists of a dose escalation phase,
followed by a dose expansion phase. Merus is also evaluating the
combination of MCLA-145 with Keytruda, with enrollment ongoing.
Collaborations
Incyte Corporation Since 2017, Merus has been
working together 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 INCA32459, a
novel Lag3xPD-1 bispecific antibody developed through the
collaboration is currently being evaluated in clinical studies. In
January 2023, Merus achieved a milestone payment of $2.5 million
related to this program.
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
second half 2025As of March 31, 2023, Merus had $287.3
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 second half 2025.
Annual General Meeting and Board of
DirectorsThe Company’s annual general meeting of
shareholders is planned to be held on May 26, 2023.
First Quarter 2023 Financial ResultsWe ended
the first quarter with cash, cash equivalents and marketable
securities of $287.3 million compared to $326.7
million at December 31, 2022. The decrease was primarily
the result of cash used to fund the operations.Collaboration
revenue for the three months ended March 31,
2023 increased by $1.8 million as compared to the
three months ended March 31, 2022, primarily as a result of an
increase from an Incyte milestone met of $2.5M partially offset by
lower cost reimbursement revenue.
Research and development expense for the three months
ended March 31, 2023 increased by $7.9
million as compared to the three months ended March 31,
2022, primarily as a result of an increase in clinical and
manufacturing costs related to our programs and stock-based
compensation.
General and administrative expense for the three months
ended March 31, 2023 increased by $3.6
million as compared to the three months ended March 31,
2022, primarily as a result of increases in consulting costs of
$2.3 million, facilities costs of $0.8 million and personnel
related expenses including stock-based compensation.
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 per share data) |
|
|
March 31,2023 |
|
|
December 31,2022 |
|
ASSETS |
|
|
|
|
|
|
Current assets: |
|
|
|
|
|
|
Cash and cash equivalents |
|
$ |
102,635 |
|
|
$ |
147,749 |
|
Marketable securities |
|
|
138,604 |
|
|
|
142,480 |
|
Accounts receivable |
|
|
4,769 |
|
|
|
4,051 |
|
Prepaid expenses and other current assets |
|
|
12,156 |
|
|
|
12,163 |
|
Total current assets |
|
|
258,164 |
|
|
|
306,443 |
|
Marketable securities |
|
|
46,103 |
|
|
|
36,457 |
|
Property and equipment,
net |
|
|
13,390 |
|
|
|
12,222 |
|
Operating lease right-of-use
assets |
|
|
12,322 |
|
|
|
12,618 |
|
Intangible assets, net |
|
|
1,933 |
|
|
|
1,950 |
|
Deferred tax assets |
|
|
2,369 |
|
|
|
2,041 |
|
Other assets |
|
|
4,239 |
|
|
|
4,811 |
|
Total assets |
|
$ |
338,520 |
|
|
$ |
376,542 |
|
LIABILITIES AND STOCKHOLDERS’ EQUITY |
|
|
|
|
|
|
Current liabilities: |
|
|
|
|
|
|
Accounts payable |
|
$ |
4,987 |
|
|
$ |
9,834 |
|
Accrued expenses and other liabilities |
|
|
39,543 |
|
|
|
35,590 |
|
Income taxes payable |
|
|
2,271 |
|
|
|
2,400 |
|
Current portion of lease obligation |
|
|
1,588 |
|
|
|
1,684 |
|
Current portion of deferred revenue |
|
|
26,698 |
|
|
|
29,418 |
|
Total current liabilities |
|
|
75,087 |
|
|
|
78,926 |
|
Lease obligation |
|
|
11,588 |
|
|
|
11,790 |
|
Deferred revenue, net of
current portion |
|
|
34,322 |
|
|
|
38,771 |
|
Total liabilities |
|
|
120,997 |
|
|
|
129,487 |
|
Commitments and contingencies
- Note 6 |
|
|
|
|
|
|
Stockholders’ equity: |
|
|
|
|
|
|
Common shares, €0.09 par value; 67,500,000 shares authorized at
March 31, 2023 and December 31, 2022; 46,341,181 and 46,310,589
shares issued and outstanding as at March 31, 2023 and
December 31, 2022, respectively |
|
|
4,754 |
|
|
|
4,751 |
|
Additional paid-in capital |
|
|
876,838 |
|
|
|
870,874 |
|
Accumulated other comprehensive income |
|
|
(26,206 |
) |
|
|
(30,448 |
) |
Accumulated deficit |
|
|
(637,863 |
) |
|
|
(598,122 |
) |
Total stockholders’ equity |
|
|
217,523 |
|
|
|
247,055 |
|
Total liabilities and
stockholders’ equity |
|
$ |
338,520 |
|
|
$ |
376,542 |
|
MERUS N.V.CONDENSED CONSOLIDATED STATEMENTS OF
OPERATIONS AND COMPREHENSIVE
LOSS(UNAUDITED)(Amounts in thousands,
except per share data) |
|
|
Three Months
EndedMarch 31, |
|
|
|
2023 |
|
|
2022 |
|
Collaboration revenue |
|
$ |
13,499 |
|
|
$ |
11,655 |
|
Total revenue |
|
|
13,499 |
|
|
|
11,655 |
|
Operating expenses: |
|
|
|
|
|
|
Research and development |
|
|
34,865 |
|
|
|
26,975 |
|
General and administrative |
|
|
15,386 |
|
|
|
11,753 |
|
Total operating expenses |
|
|
50,251 |
|
|
|
38,728 |
|
Operating loss |
|
|
(36,752 |
) |
|
|
(27,073 |
) |
Other (loss) income, net: |
|
|
|
|
|
|
Interest (expense) income, net |
|
|
1,995 |
|
|
|
106 |
|
Foreign exchange gains (loss) |
|
|
(5,441 |
) |
|
|
7,730 |
|
Other (losses) gains, net |
|
|
— |
|
|
|
458 |
|
Total other income (loss),
net |
|
|
(3,446 |
) |
|
|
8,294 |
|
|
|
|
|
|
|
|
Net loss before income
taxes |
|
|
(40,198 |
) |
|
|
(18,779 |
) |
Income tax expense |
|
|
(457 |
) |
|
|
114 |
|
Net loss |
|
$ |
(39,741 |
) |
|
$ |
(18,893 |
) |
Other comprehensive loss: |
|
|
|
|
|
|
Currency translation adjustment |
|
|
4,242 |
|
|
|
(6,048 |
) |
Comprehensive loss |
|
$ |
(35,499 |
) |
|
$ |
(24,941 |
) |
Net loss per share
attributable to common stockholders: |
|
|
|
|
|
|
|
|
Basic and diluted |
|
$ |
(0.86 |
) |
|
$ |
(0.43 |
) |
Weighted-average common shares
outstanding: |
|
|
|
|
|
|
|
|
Basic and diluted |
|
|
46,323,772 |
|
|
|
43,489,870 |
|
|
|
|
|
|
|
|
|
|
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, www.merus.nl and https://twitter.com/MerusNV.
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; the continuation of enrollment
of patients in the eNRGy trial to assess the safety and anti-tumor
activity of Zeno monotherapy in NRG1+ cancers; our clinical trial
evaluating Zeno in combination with afatinib for NRG1+ NSCLC; our
clinical trial evaluating Zeno in combination with an ADT as a
potential treatment for CRPC; statements regarding the sufficiency
of our cash, cash equivalents and marketable securities, and
expectation that it will fund the Company into the second half of
2025 and expectation that our cash position will continue to fund
the company meaningfully beyond several near-term clinical
milestones and program updates; the advancement of the phase 1
trial of MCLA-145, as monotherapy and in combination with Keytruda;
the advancement of the phase 1/2 trial for petosemtamab; statements
regarding advancing our petosemtamab program diligently toward a
registration-directed study in head and neck cancer; the
advancement of the phase 1/2 trial for MCLA-129 in the dose
expansion phase, in monotherapy in Met ex14 NSCLC, EGFR ex20 NSCLC,
and 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 INCA32459 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. 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-K for the period
ended December 31, 2022, filed with the Securities and Exchange
Commission, or SEC, on February 28, 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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