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
TumorsLiGeR-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 tumorsZeno 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
TumorsInvestigation 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 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. 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 CompanyIn 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 SciencesIn 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 PharmaceuticalIn 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
EndedSeptember 30, |
|
|
Nine Months
EndedSeptember 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 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
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.
Investor and Media Inquiries:
Sherri Spear
Merus N.V.
SVP Investor Relations and Strategic Communications
617-821-3246
s.spear@merus.nl
Kathleen Farren
Merus N.V.
Associate Director Investor Relations and Corporate Communications
617-230-4165
k.farren@merus.nl
Merus NV (NASDAQ:MRUS)
과거 데이터 주식 차트
부터 12월(12) 2024 으로 1월(1) 2025
Merus NV (NASDAQ:MRUS)
과거 데이터 주식 차트
부터 1월(1) 2024 으로 1월(1) 2025
