Merus Announces Financial Results for the Second Quarter 2024 and
Provides Business Update
– Petosemtamab in combination with
pembrolizumab interim data presented at 2024 ASCO®
demonstrated robust 67% response rate among 24 evaluable
patients
– First patients dosed in phase 3 trial
evaluating petosemtamab monotherapy in 2/3L HNSCC, phase 2 trial
evaluating petosemtamab in combination with standard chemotherapy
in 2L mCRC, and phase 2 trial evaluating MCLA-129 in combination
with chemotherapy in 2L+ EGFRm NSCLC
– Based on the Company’s current
operating plan, existing cash, cash equivalents, including
successful public offering raising $460M gross
proceeds, and marketable securities expected to fund
Merus’ operations into 2028
UTRECHT, The Netherlands and CAMBRIDGE, Mass., Aug. 01, 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 second quarter and provided a business
update.
“Petosemtamab has already demonstrated potential for best in
class efficacy with a favorable safety profile in both 1L and 2L+
HNSCC, major areas of unmet medical need. I’m also looking forward
to evaluating petosemtamab in mCRC, another potential important
opportunity,” said Bill Lundberg, M.D., President, Chief
Executive Officer of Merus. “With the addition of Dr. Fabian Zohren
as CMO and the recent successful equity financing raising $460M
gross proceeds, we are well positioned for our ambitious phase 3
trial plans for petosemtamab in HNSCC and beyond.”
Petosemtamab (MCLA-158: EGFR x LGR5
Biclonics®): Solid Tumors
LiGeR-HN2 phase 3 trial in 2/3L head and neck squamous cell
carcinoma (HNSCC) enrolling and LiGeR-HN1 phase 3 trial in 1L HNSCC
planned to initiate by year end 2024; phase 2 trial in 2L
metastatic colorectal cancer (mCRC) enrolling; clinical data update
on 2L+ HNSCC planned for late fourth quarter of 2024
Merus has confirmed through feedback with the U.S. Food and Drug
Administration (FDA) that petosemtamab 1500 mg every two weeks is
appropriate for further development in HNSCC as monotherapy, and in
combination with pembrolizumab.
Merus provided an interim clinical update on petosemtamab with
pembrolizumab in 1L HNSCC at the 2024 American Society of Clinical
Oncology® (ASCO®) Annual Meeting,
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 (recurrent/metastatic) HNSCC (May 28, 2024). Merus plans to
initiate LiGeR-HN1, a phase 3 trial evaluating petosemtamab in
combination with pembrolizumab in 1L HNSCC by year end 2024.
Merus 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 Merus’
Petosemtamab Interim Data Demonstrates Clinically Meaningful
Activity in Previously Treated Head and Neck Squamous Cell
Carcinoma (HNSCC) (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
in late fourth quarter of 2024.
Merus announced the first patient was dosed in LiGeR-HN2, a
phase 3 trial evaluating the efficacy and safety of petosemtamab in
2/3L HNSCC compared to standard of care. In this trial, patients
will be randomized to petosemtamab monotherapy or investigator’s
choice of single agent chemotherapy or cetuximab. This was detailed
in our press release, Merus Announces First Patient Dosed in
LiGeR-HN2, a Phase 3 Trial Evaluating Petosemtamab in 2/3L r/m
HNSCC - Merus (July 24, 2024).
The FDA has granted Breakthrough Therapy Designation (BTD)
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
receptor-1 (PD-1) or anti-programmed death ligand 1 (PD-L1)
antibody. This designation was detailed in our press release,
Petosemtamab granted Breakthrough Therapy Designation by the U.S.
FDA (May 13, 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.
Merus announced the first patient was dosed in the phase 2
open-label trial evaluating the safety and preliminary antitumor
activity of petosemtamab with FOLFIRI in 2L mCRC. Trial design 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 zenocutuzumab (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
At 2024 ASCO® Merus presented efficacy and safety
data of MCLA-129, in NSCLC with c-MET exon 14 skipping mutations
(METex14). This poster presentation was detailed in our press
release Merus’ MCLA-129 Demonstrates Promising Single-Agent
Efficiency in METex14 NSCLC in Poster Presentation at the 2024
ASCO® Annual Meeting (June 3, 2024).
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
Interim clinical data on MCLA-145 monotherapy and in
combination with pembrolizumab in patients with advanced/metastatic
solid tumors were presented at 2024 ASCO®. The oral
presentation was detailed in our press release Merus Presents
Interim Data on MCLA-145 Monotherapy and in Combination with
Pembrolizumab at the 2024 ASCO® Annual Meeting (June 2,
2024).
Company News
Merus announced the appointment of Fabian Zohren M.D., Ph.D.
as Chief Medical Officer (CMO). This management addition is
detailed in our press release Merus Appoints Fabian Zohren M.D.,
Ph.D., as Chief Medical Officer (July 1, 2024).
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. During the second
quarter of 2024, Merus received the milestone payment of $1 million
for the candidate nomination accomplished in first quarter of
2024.
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.
Corporate Activities
Completed public offering raising $460M gross
proceeds
This equity raise is detailed in a press release: Merus Announces
Pricing of Upsized Public Offering of Common Shares (May 29,
2024).
Cash Runway, existing cash, cash equivalents and
marketable securities expected to fund Merus’ operations into
2028
As of June 30, 2024, Merus had $846.4
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.
Second Quarter 2024 Financial
Results
We ended the second quarter with cash, cash equivalents and
marketable securities of $846.4 million compared
to $411.7 million at December 31, 2023.
Collaboration revenue for the three months ended June 30,
2024 decreased by $3.2 million as compared to the
three months ended June 30, 2023, primarily as a result of
decreases in reimbursement revenue of $1.5 million and
amortization of deferred revenue of $1.7 million.
Research and development expense for the three months
ended June 30, 2024 increased by $20.8
million as compared to the three months ended June 30,
2023, primarily as a result of increases in external clinical
services and drug manufacturing expenses, including costs to
fulfill our obligations under our collaboration agreements, related
to our programs of $16.2 million, consulting expenses of $2.2
million, facilities and depreciation expenses of $1.2 million,
personnel related expenses including share-based compensation of
$1.0 million, consumables expenses of $0.1 million, and travel
expenses of $0.1 million.
General and administrative expense for the three months
ended June 30, 2024 increased by $6.5
million as compared to the three months
ended June 30, 2023, primarily as a result of increases
in personnel related expenses including share-based compensation of
$3.7 million, consulting expenses of $3.6 million, intellectual
property and license expenses of $0.5 million, and legal expenses
of $0.4 million, partially offset by decreases in facilities and
depreciation expense of $1.2 million, travel expenses of $0.3
million, and finance and human resources expenses of $0.2
million.
Collaboration revenue for the six months
ended June 30, 2024 decreased by $8.8
million as compared to the six months ended June 30,
2023, primarily as a result of a decrease in reimbursement revenue
of $2.2 million, decrease in milestone revenue of $1.5
million and decrease in amortization of deferred revenue
of $5.1 million.
Research and development expense for the six months
ended June 30, 2024 increased by $24.5
million as compared to the six months ended June 30,
2023, primarily as a result of increases in external clinical
services and drug manufacturing expenses, including costs to
fulfill our obligations under our collaboration agreements, related
to our programs of $19.4 million, consulting expenses of $3.7
million, facilities and depreciation expenses of $2.3 million,
pre-launch inventory of $0.2 million, and travel expenses of $0.2
million, partially offset by decreases in personnel related
expenses including share-based compensation of $1.2 million and
consumables expenses of $0.1 million
General and administrative expense for the six months ended
June 30, 2024 increased by $7.3 million as compared to the six
months ended June 30, 2023, primarily as a result of increases
in personnel related expenses including share-based compensation of
$4.5 million, consulting expenses of $3.2 million, legal expenses
of $1.0 million, and intellectual property and license expenses of
$0.8 million, partially offset by decreases in facilities and
depreciation expense of $1.7 million, travel expenses of $0.3
million, and finance and human resources expenses of $0.2
million
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) |
|
|
|
|
|
|
|
|
June 30, 2024 |
|
|
December 31, 2023 |
|
ASSETS |
|
|
|
|
|
Current assets: |
|
|
|
|
|
Cash and cash equivalents |
$ |
629,475 |
|
|
$ |
204,246 |
|
Marketable securities |
|
157,948 |
|
|
|
150,130 |
|
Accounts receivable |
|
1,842 |
|
|
|
2,429 |
|
Prepaid expenses and other current assets |
|
17,288 |
|
|
|
12,009 |
|
Total current assets |
|
806,553 |
|
|
|
368,814 |
|
Marketable securities |
|
58,961 |
|
|
|
57,312 |
|
Property and equipment, net |
|
12,090 |
|
|
|
12,135 |
|
Operating lease right-of-use
assets |
|
10,291 |
|
|
|
11,362 |
|
Intangible assets, net |
|
1,658 |
|
|
|
1,800 |
|
Deferred tax assets |
|
543 |
|
|
|
1,199 |
|
Other assets |
|
2,132 |
|
|
|
2,872 |
|
Total assets |
$ |
892,228 |
|
|
$ |
455,494 |
|
LIABILITIES AND SHAREHOLDERS’ EQUITY |
|
|
|
|
|
Current liabilities: |
|
|
|
|
|
Accounts payable |
$ |
4,395 |
|
|
$ |
4,602 |
|
Accrued expenses and other liabilities |
|
40,826 |
|
|
|
38,482 |
|
Income taxes payable |
|
1,605 |
|
|
|
1,646 |
|
Current portion of lease obligation |
|
1,688 |
|
|
|
1,674 |
|
Current portion of deferred revenue |
|
32,350 |
|
|
|
22,685 |
|
Total current liabilities |
|
80,864 |
|
|
|
69,089 |
|
Lease obligation |
|
9,332 |
|
|
|
10,488 |
|
Deferred revenue, net of current
portion |
|
55,260 |
|
|
|
19,574 |
|
Total liabilities |
|
145,456 |
|
|
|
99,151 |
|
Commitments and contingencies -
Note 6 |
|
|
|
|
|
Shareholders’ equity: |
|
|
|
|
|
Common shares, €0.09 par value; 105,000,000 shares authorized at
June 30, 2024 and December 31, 2023; 67,852,920 and
57,825,879 shares issued and outstanding as at June 30, 2024
and December 31, 2023, respectively |
|
6,863 |
|
|
|
5,883 |
|
Additional paid-in capital |
|
1,616,367 |
|
|
|
1,126,054 |
|
Accumulated other comprehensive income |
|
(38,899 |
) |
|
|
(22,533 |
) |
Accumulated deficit |
|
(837,559 |
) |
|
|
(753,061 |
) |
Total shareholders’ equity |
|
746,772 |
|
|
|
356,343 |
|
Total liabilities and
shareholders’ equity |
$ |
892,228 |
|
|
$ |
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 June 30, |
|
|
Six Months
Ended June 30, |
|
|
2024 |
|
|
2023 |
|
|
2024 |
|
|
2023 |
|
Collaboration revenue |
$ |
7,332 |
|
|
$ |
10,476 |
|
|
$ |
15,221 |
|
|
$ |
23,975 |
|
Total revenue |
|
7,332 |
|
|
|
10,476 |
|
|
|
15,221 |
|
|
|
23,975 |
|
Operating expenses: |
|
|
|
|
|
|
|
|
|
|
|
Research and development |
|
49,119 |
|
|
|
28,298 |
|
|
|
87,703 |
|
|
|
63,163 |
|
General and administrative |
|
22,587 |
|
|
|
16,063 |
|
|
|
38,701 |
|
|
|
31,449 |
|
Total operating expenses |
|
71,706 |
|
|
|
44,361 |
|
|
|
126,404 |
|
|
|
94,612 |
|
Operating loss |
|
(64,374 |
) |
|
|
(33,885 |
) |
|
|
(111,183 |
) |
|
|
(70,637 |
) |
Other income, net: |
|
|
|
|
|
|
|
|
|
|
|
Interest income, net |
|
7,130 |
|
|
|
2,795 |
|
|
|
12,047 |
|
|
|
4,790 |
|
Foreign exchange gains (loss) |
|
9,519 |
|
|
|
551 |
|
|
|
18,053 |
|
|
|
(4,890 |
) |
Total other income (loss),
net |
|
16,649 |
|
|
|
3,346 |
|
|
|
30,100 |
|
|
|
(100 |
) |
|
|
|
|
|
|
|
|
|
|
|
|
Net loss before income taxes |
|
(47,725 |
) |
|
|
(30,539 |
) |
|
|
(81,083 |
) |
|
|
(70,737 |
) |
Income tax expense |
|
2,317 |
|
|
|
1,494 |
|
|
|
3,415 |
|
|
|
1,037 |
|
Net loss |
$ |
(50,042 |
) |
|
$ |
(32,033 |
) |
|
$ |
(84,498 |
) |
|
$ |
(71,774 |
) |
Other comprehensive loss: |
|
|
|
|
|
|
|
|
|
|
|
Currency translation adjustment |
|
(8,978 |
) |
|
|
(505 |
) |
|
|
(16,366 |
) |
|
|
3,737 |
|
Comprehensive loss |
$ |
(59,020 |
) |
|
$ |
(32,538 |
) |
|
$ |
(100,864 |
) |
|
$ |
(68,037 |
) |
Net loss per share attributable
to common stockholders:
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Basic and diluted |
$ |
(0.81 |
) |
|
$ |
(0.66 |
) |
|
$ |
(1.41 |
) |
|
$ |
(1.52 |
) |
Weighted-average common shares
outstanding:
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Basic and diluted |
|
61,851,260 |
|
|
|
48,321,708 |
|
|
|
59,968,338 |
|
|
|
47,328,259 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
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 planned initiation of LiGeR-HN1 by year-end, our planned update
by late 4Q 2024 on the HNSCC 2L+ dose cohort and patients
previously reported at AACR2023; the potential of petosetmamab for
best in class efficacy with a favorable safety profile in both 1L
and 2L+ HNSCC; the potential opportunity of petosemtamab being
investigated in 2L mCRC in combination with FOLFIRI; our belief
that we are well positioned for our ambitious phase 3 trial plans
for petosemtamab in HNSCC and beyond; the potential future benefit
if any for the receipt of BTD 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 receptor-1 (PD-1) or anti-programmed
death ligand 1 (PD-L1) antibody; 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 advancement of the phase 1/2
trial for MCLA-129 in the dose expansion phase, in monotherapy in
Met ex14 NSCLC, and MCLA-129 in combination with chemotherapy in
2L+ EGFRm NSCLC; the benefits of the collaborations between Incyte
and Merus, Lilly and Merus, Gilead and Merus, and the potential of
those collaboration for future value generation, including whether
and when Merus will receive any future payment under the
collaborations, 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 June 30, 2024, filed with the Securities and Exchange
Commission, or SEC, on August 1, 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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Merus NV (TG:2GH)
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From Oct 2023 to Oct 2024