Merus Announces Financial Results for the Third Quarter 2024 and
Provides Business Update
- Phase 3 registrational trials
evaluating petosemtamab in combination with pembrolizumab in 1L and
petosemtamab monotherapy in 2/3L r/m HNSCC enrolling
-
Petosemtamab in 2L+ r/m HNSCC interim clinical data accepted
for rapid oral presentation at ESMO® Asia Congress
2024
-
Based on the Company’s current operating plan, existing cash,
cash equivalents, and marketable securities expected to fund Merus’
operations into 2028
UTRECHT, The Netherlands and CAMBRIDGE, Mass., Oct. 31, 2024
(GLOBE NEWSWIRE) -- 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.
“I'm encouraged by our continued operational effectiveness, with
phase 3 trials accelerating for petosemtamab in both 1L and 2/3L
recurrent/metastatic head and neck cancer. I believe petosemtamab
has the potential to offer both a first and best in class
chemo-free option for these patients,” said Bill Lundberg,
M.D., President, Chief Executive Officer of Merus. “We look forward
to providing an update on petosemtamab’s monotherapy efficacy,
duration and safety in 2L+ HNSCC this December at ESMO® Asia and,
in the near future, providing more information on a number of
important potential near term catalysts in 2025.”
Petosemtamab (MCLA-158: EGFR x LGR5 Biclonics®):
Solid Tumors
LiGeR-HN1 phase 3 trial in 1L head and neck squamous cell
carcinoma (HNSCC) and LiGeR-HN2 phase 3 trial in 2/3L HNSCC
enrolling; phase 2 trial in 2L metastatic colorectal cancer (mCRC)
enrolling; clinical data update on 2L+ HNSCC planned for ESMO® Asia
in December 2024
In the third quarter, Merus announced the first patient was
dosed in LiGeR-HN1, a phase 3 trial evaluating the efficacy and
safety of petosemtamab in combination with pembrolizumab in 1L
HNSCC expressing PD-L1 (CPS≥1) compared to pembrolizumab. In this
trial, patients will be randomized to petosemtamab plus
pembrolizumab or pembrolizumab monotherapy. This was detailed in
our press release, Merus Announces First Patient Dosed in
LiGeR-HN1, a Phase 3 Trial Evaluating Petosemtamab in Combination
with Pembrolizumab in 1L r/m HNSCC (September 30, 2024).
Merus provided an interim clinical update on petosemtamab with
pembrolizumab in 1L r/m HNSCC at the American Society of Clinical
Oncology® (ASCO) Annual Meeting 2024, demonstrating a 67% response
rate among 24 evaluable patients. The oral presentation was
detailed in our press release, Merus’ Petosemtamab in Combination
with Pembrolizumab Interim Data Demonstrates Robust Response Rate
and Favorable Safety Profile in 1L r/m HNSCC (May 28, 2024).
Merus also provided an interim clinical update on petosemtamab
monotherapy in 2L+ HNSCC at the American Association of Cancer
Research® (AACR®) Annual Meeting 2023, demonstrating a 37%
response rate among 43 evaluable patients. The oral presentation
was detailed in our press release (April 17, 2023). Merus plans to
provide updated efficacy, durability and safety data of this cohort
along with clinical data from the dose optimization cohort
evaluating petosemtamab monotherapy 1500 or 1100 mg dose levels in
2L+HNSCC. This was detailed in our press release, Merus Announces
Abstract Accepted for Presentation at the ESMO Asia Congress 2024
(September 17, 2024).
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.
In the third quarter, Merus announced the first patient was
dosed in a phase 2 trial evaluating petosemtamab in combination
with standard chemotherapy in 2L mCRC. This was detailed in our
press release, Merus Announces First Patient Dosed in Phase 2 Trial
of Petosemtamab in 2L CRC (July 8, 2024).
Zenocutuzumab (Zeno or MCLA-128: HER2 x HER3
Biclonics®): NRG1 fusion-positive (NRG1+) lung, pancreatic and
other solid tumors
Zeno BLA for treatment of NRG1+ non-small cell lung cancer
(NSCLC) and pancreatic cancer (PDAC) accepted for priority review
by the FDA
The FDA has accepted for priority review a Biologics License
Application (BLA) for the bispecific antibody Zeno in patients with
NRG1+ NSCLC and PDAC cancer. This acceptance was detailed in our
press release Merus Announces U.S. FDA Acceptance and Priority
Review of Biologics License Application for Zeno for the Treatment
of NRG1+ NSCLC and PDAC (May 6, 2024).
Merus believes that obtaining a commercialization partnership
agreement is an important step in bringing Zeno to patients with
NRG1+ cancer, if approved.
MCLA-129 (EGFR x c-MET Biclonics®): Solid
Tumors
Investigation of MCLA-129 is ongoing in METex14 NSCLC; phase 2
trial in combination with chemotherapy in 2L+ EGFR mutant (EGFRm)
NSCLC enrolling
In the third quarter, Merus announced the first patients were
dosed in the phase 2 trial evaluating MCLA-129 in combination with
chemotherapy in 2L+ EGFRm NSCLC, with a cohort receiving MCLA-129
and paclitaxel and carboplatin, and another cohort receiving
MCLA-129 and docetaxel. We also remain interested in partnering
MCLA-129 to sufficiently resource the development of MCLA-129 and
the 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
Tumors
Investigation continues of the phase 1 trial of MCLA-145 in
combination with pembrolizumab
Collaborations
Incyte Corporation
Since 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. 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.
Eli Lilly and Company
In January 2021, Merus and 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 Lilly. The
collaboration is progressing well with three programs ongoing at
various stages of preclinical development.
Gilead Sciences
In March 2024, Merus and Gilead Sciences announced a collaboration
to discover novel antibody based trispecific T-cell engagers using
Merus’ patented Triclonics® platform. Under the terms of the
agreement, Merus will lead early-stage research activities for two
programs, with an option to pursue a third. Gilead will have the
right to exclusively license programs developed under the
collaboration after the completion of select research activities.
If Gilead exercises its option to license any such program from the
collaboration, Gilead will be responsible for additional research,
development and commercialization activities for such program.
Merus received an equity investment by Gilead of $25 million in
Merus common shares and an upfront payment of $56 million.
Ono Pharmaceutical
In 2018, the Company granted Ono Pharmaceutical Co., Ltd.
(Ono) an exclusive, worldwide, royalty-bearing license, with the
right to sublicense, research, test, make, use and market a limited
number of bispecific antibody candidates based on Merus’
Biclonics® technology platform directed to an
undisclosed target combination. During the third quarter of 2024,
Merus achieved and received a milestone payment based on the filing
of an Investigational New Drug (IND) application in Japan.
Cash Runway, existing cash, cash equivalents and
marketable securities expected to fund Merus’ operations into
2028
As of September 30, 2024, Merus had $782.9
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 2028.
Third Quarter 2024 Financial
Results
Collaboration revenue for the three months ended
September 30, 2024 increased by $0.8 million as compared to
the three months ended September 30, 2023, primarily as a
result of increases in amortization of upfront deferred revenue.
The change in exchange rates did not significantly impact
collaboration revenue.
Research and development expense for the three months ended
September 30, 2024 increased by $26.5 million as compared to
the three months ended September 30, 2023, primarily as a
result of increases in external clinical services and drug
manufacturing expenses.
General and administrative expense for the three months ended
September 30, 2024 increased by $8.2 million as compared to
the three months ended September 30, 2023, primarily as a
result of increases in personnel related expenses, facilities,
depreciation expense and consulting expenses.
Collaboration revenue for the nine months ended
September 30, 2024 decreased by $8.0 million as compared to
the nine months ended September 30, 2023, primarily as a
result of decreases in milestone revenue and amortization of
deferred revenue.
Research and development expense for the nine months ended
September 30, 2024 increased by $51.0 million as compared to
the nine months ended September 30, 2023, primarily as a
result of increases in external clinical services and drug
manufacturing expenses.
General and administrative expense for the nine months ended
September 30, 2024 increased by $15.5 million as compared to
the nine months ended September 30, 2023, primarily as a
result of increases in personnel related expenses and consulting
expenses.
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,
2024 |
|
|
December 31,
2023 |
|
ASSETS |
|
|
|
|
|
|
Current assets: |
|
|
|
|
|
|
Cash and cash equivalents |
|
$ |
432,998 |
|
|
$ |
204,246 |
|
Marketable securities |
|
|
199,270 |
|
|
|
150,130 |
|
Accounts receivable |
|
|
1,134 |
|
|
|
2,429 |
|
Prepaid expenses and other current assets |
|
|
32,874 |
|
|
|
12,009 |
|
Total current assets |
|
|
666,276 |
|
|
|
368,814 |
|
Marketable securities |
|
|
150,620 |
|
|
|
57,312 |
|
Property and equipment, net |
|
|
12,146 |
|
|
|
12,135 |
|
Operating lease right-of-use
assets |
|
|
10,312 |
|
|
|
11,362 |
|
Intangible assets, net |
|
|
1,856 |
|
|
|
1,800 |
|
Deferred tax assets |
|
|
838 |
|
|
|
1,199 |
|
Other assets |
|
|
2,628 |
|
|
|
2,872 |
|
Total assets |
|
$ |
844,676 |
|
|
$ |
455,494 |
|
LIABILITIES AND SHAREHOLDERS’ EQUITY |
|
|
|
|
|
|
Current liabilities: |
|
|
|
|
|
|
Accounts payable |
|
$ |
6,185 |
|
|
$ |
4,602 |
|
Accrued expenses and other liabilities |
|
|
36,279 |
|
|
|
38,482 |
|
Income taxes payable |
|
|
4,876 |
|
|
|
1,646 |
|
Current portion of lease obligation |
|
|
1,762 |
|
|
|
1,674 |
|
Current portion of deferred revenue |
|
|
30,974 |
|
|
|
22,685 |
|
Total current liabilities |
|
|
80,076 |
|
|
|
69,089 |
|
Lease obligation |
|
|
9,284 |
|
|
|
10,488 |
|
Deferred revenue, net of current
portion |
|
|
52,055 |
|
|
|
19,574 |
|
Total liabilities |
|
|
141,415 |
|
|
|
99,151 |
|
Commitments and contingencies -
Note 6 |
|
|
|
|
|
|
Shareholders’ equity: |
|
|
|
|
|
|
Common shares, €0.09 par value; 105,000,000 shares authorized at
September 30, 2024 and December 31, 2023;
68,426,779 and 57,825,879 shares issued and outstanding as at
September 30, 2024 and December 31, 2023,
respectively |
|
|
6,919 |
|
|
|
5,883 |
|
Additional paid-in capital |
|
|
1,640,930 |
|
|
|
1,126,054 |
|
Accumulated other comprehensive income |
|
|
(7,124 |
) |
|
|
(22,533 |
) |
Accumulated deficit |
|
|
(937,464 |
) |
|
|
(753,061 |
) |
Total shareholders’ equity |
|
|
703,261 |
|
|
|
356,343 |
|
Total liabilities and
shareholders’ equity |
|
$ |
844,676 |
|
|
$ |
455,494 |
|
MERUS N.V.
CONDENSED CONSOLIDATED STATEMENTS OF OPERATIONS AND
COMPREHENSIVE LOSS
(UNAUDITED)
(Amounts in thousands, except share and per share
data)
|
|
|
Three Months Ended
September 30, |
|
|
Nine Months Ended
September 30, |
|
|
|
2024 |
|
|
2023 |
|
|
2024 |
|
|
2023 |
|
Collaboration revenue |
|
$ |
11,772 |
|
|
$ |
11,033 |
|
|
$ |
26,993 |
|
|
$ |
35,008 |
|
Total revenue |
|
|
11,772 |
|
|
|
11,033 |
|
|
|
26,993 |
|
|
|
35,008 |
|
Operating expenses: |
|
|
|
|
|
|
|
|
|
|
|
|
Research and development |
|
|
63,239 |
|
|
|
36,810 |
|
|
|
150,942 |
|
|
|
99,973 |
|
General and administrative |
|
|
20,765 |
|
|
|
12,591 |
|
|
|
59,466 |
|
|
|
44,040 |
|
Total operating expenses |
|
|
84,004 |
|
|
|
49,401 |
|
|
|
210,408 |
|
|
|
144,013 |
|
Operating loss |
|
|
(72,232 |
) |
|
|
(38,368 |
) |
|
|
(183,415 |
) |
|
|
(109,005 |
) |
Other income, net: |
|
|
|
|
|
|
|
|
|
|
|
|
Interest income, net |
|
|
10,254 |
|
|
|
4,522 |
|
|
|
22,301 |
|
|
|
9,312 |
|
Foreign exchange gains (loss) |
|
|
(34,950 |
) |
|
|
11,952 |
|
|
|
(16,897 |
) |
|
|
7,062 |
|
Total other income (loss),
net |
|
|
(24,696 |
) |
|
|
16,474 |
|
|
|
5,404 |
|
|
|
16,374 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Net loss before income taxes |
|
|
(96,928 |
) |
|
|
(21,894 |
) |
|
|
(178,011 |
) |
|
|
(92,631 |
) |
Income tax expense |
|
|
2,977 |
|
|
|
1,118 |
|
|
|
6,392 |
|
|
|
2,155 |
|
Net loss |
|
$ |
(99,905 |
) |
|
$ |
(23,012 |
) |
|
$ |
(184,403 |
) |
|
$ |
(94,786 |
) |
Other comprehensive loss: |
|
|
|
|
|
|
|
|
|
|
|
|
Currency translation adjustment |
|
|
31,775 |
|
|
|
(10,722 |
) |
|
|
15,409 |
|
|
|
(6,985 |
) |
Comprehensive loss |
|
$ |
(68,130 |
) |
|
$ |
(33,734 |
) |
|
$ |
(168,994 |
) |
|
$ |
(101,771 |
) |
Net loss per share attributable
to common stockholders:
Basic and diluted |
|
$ |
(1.46 |
) |
|
$ |
(0.43 |
) |
|
$ |
(2.94 |
) |
|
$ |
(1.91 |
) |
Weighted-average common shares
outstanding:
Basic and diluted |
|
|
68,254,120 |
|
|
|
53,869,762 |
|
|
|
62,750,425 |
|
|
|
49,532,722 |
|
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 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; our ability to successfully advance Zeno through the
regulatory, BLA review and potential commercialization processes;
our ongoing LiGeR-HN1, LiGeR-HN2 and phase 2 mCRC trials for
petosemtamab, our planned update at ESMO Asia in December on the
HNSCC 2L+ dose cohort and patients previously reported at AACR
2023; our belief that petosemtamab has the potential to offer both
a first and best in class chemo-free option for r/m HNSCC patients;
our belief that 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; our belief that obtaining a commercialization
partnership agreement is an important step in bringing Zeno to
patients with NRG1+ cancer, if approved; statements regarding the
sufficiency of our cash, cash equivalents and marketable
securities, and expectation that it will fund the Company into
2028; the continued investigation of MCLA-145 in combination with
pembrolizumab; the investigation of MCLA-129 in monotherapy in Met
ex14 NSCLC, and enrolling of patients in the investigation of
MCLA-129 in combination with chemotherapy in 2L+ EGFRm NSCLC; our
interest in partnering MCLA-129 to sufficiently resource the
development of MCLA-129 and the potential benefit it may have for
patients; the benefits of the collaborations between Incyte and
Merus, Lilly and Merus, Gilead and Merus, and license agreement
between Ono and Merus; and the potential of those collaborations
and license for future value generation, including whether and when
Merus will receive any future payments, 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 volatility in the global
economy, including global instability, including the ongoing
conflicts in Europe and the Middle East; 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; and
our registered or unregistered trademarks or trade names may be
challenged, infringed, circumvented or declared generic or
determined to be infringing on other marks.
These and other important factors discussed under the caption
“Risk Factors” in our Quarterly Report on Form 10-Q for the period
ended September 30, 2024, filed with the Securities and Exchange
Commission, or SEC, on October 31, 2024, 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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