* Petosemtamab in combination with pembrolizumab in 1L HNSCC initial interim

    clinical data at 2024 ASCO Annual Meeting; preparing for a potential phase
    3 trial
  * Zeno BLA accepted for priority review by the FDA for the treatment of NRG1+
    NSCLC and PDAC
  * Based on the Company's current operating plan, existing cash, cash
    equivalents and marketable securities expected to fund Merus' operations
    into 2027

UTRECHT, The Netherlands and CAMBRIDGE, Mass., May 08, 2024 (GLOBE NEWSWIRE) --
Merus N.V. (https://merus.nl/) (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.
"At the upcoming 2024 ASCO meeting, we are looking forward to presenting
multiple datasets including the first clinical data on safety and efficacy of
petosemtamab in combination with pembrolizumab in previously untreated head and
neck cancer. With petosemtamab, we continue to believe we have the opportunity
to significantly improve the lives of patients with both previously treated, as
well as newly diagnosed, head and neck cancer and thus, it remains the focus of
the company's resources," said Bill Lundberg, M.D., President, Chief Executive
Officer of Merus. "Additionally, we are thrilled that Zeno's BLA has been
accepted for priority review, a tremendous milestone for Merus representing our
first Biclonics® advancing from discovery to marketing application."
Petosemtamab (MCLA-158: EGFR x LGR5 Biclonics®): Solid Tumors
1L head & neck squamous cell carcinoma (HNSCC) in combination with pembrolizumab
ongoing, presentation at 2024 ASCO; previously treated (2L+) HNSCC phase 3
registration trial planned to initiate mid-2024 and dose comparison of
petosemtamab monotherapy 1100 vs 1500 mg in 2L+ HNSCC ongoing; planned
initiation of 2L colorectal cancer (CRC) cohort in 2024
An abstract entitled: Petosemtamab (MCLA-158) with pembrolizumab as first-line
(1L) treatment of recurrent/metastatic (r/m) head and neck squamous cell
carcinoma (HNSCC): Phase 2 study was accepted for rapid oral session
presentation at 2024 ASCO. Merus plans to report initial interim efficacy and
safety data from this cohort.
Merus 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 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.
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. Merus plans to provide updated efficacy, durability and safety data of
this cohort in the second half of 2024.
In 2024, Merus is planning to initiate the evaluation of petosemtamab with
standard chemotherapy in 2L CRC.
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+ NSCLC and PDAC accepted for priority review by
the FDA
The U.S. Food and Drug Administration (FDA) has accepted for priority review a
Biologics License Application (BLA) for the bispecific antibody zenocutuzumab
(Zeno) in patients with NRG1+ non-small cell lung cancer (NSCLC) and pancreatic
(PDAC) cancer. If approved, Zeno will be the first and only targeted therapy for
patients with NRG1+ NSCLC and PDAC.
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. Merus presented a pre-clinical
poster: Zenocutuzumab, a HER2xHER3 bispecific antibody, is effective in cancer
models with high NRG1 expression at the AACR Annual Meeting 2024.
Merus believes that obtaining a commercialization partnership agreement will be
an essential step in bringing Zeno to patients with NRG1+ cancer, if approved.
MCLA-129 (EGFR x c-MET Biclonics®): Solid Tumors
Investigation 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
An abstract entitled: Efficacy and safety of MCLA-129, an anti-EGFR/c-MET
bispecific antibody, in non-small-cell lung cancer (NSCLC) with c-MET exon 14
skipping mutations (METex14) was accepted for poster presentation at 2024 ASCO.
We plan to start a cohort investigating MCLA-129 in combination with
chemotherapy in 2L+ EGFRm NSCLC in 2024. We also remain interested in exploring
partnering MCLA-129 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. An abstract sponsored by Betta entitled: Efficacy and
safety of MCLA-129, an EGFR/c-MET bispecific antibody, in advanced non-small
cell lung cancer (NSCLC) was accepted for poster presentation at 2024 ASCO.
MCLA-145 (CD137 x PD-L1 Biclonics®): Solid Tumors
Investigation continues of the phase 1 trial of MCLA-145 in combination with
pembrolizumab
An abstract entitled: Phase I study of MCLA-145, a bispecific antibody targeting
CD137 and PD-L1, in solid tumors, as monotherapy or in combination with
pembrolizumab was accepted for rapid oral session presentation at 2024 ASCO.
Research
At the 20th Annual PEGS Boston meeting on May 14th, Merus plans to present
preclinical validation of the compatibility and favorable pharmaceutical
properties of Biclonics® conjugated with a range of linkers and payloads to
generate antibody-drug conjugates (ADClonics(TM)), demonstrating our platform
and format holds the potential for improved binding selectivity, internalization
and cancer cell killing activity.
Company News
Effective May 7, 2024, Jason Haddock was appointed to the Merus Board of
Directors. Most recently, he served as Chief Financial Officer (CFO) at Archer
Dx from May to August 2020 until it was acquired by Invitae Corporation. From
2016 to 2019, he served as CFO of Array BioPharma, Inc. and from 2015 to 2016,
Mr. Haddock served as CFO and Chief Operating Officer (COO) of BERG. Mr. Haddock
spent 15 years (2001-2015) at Bristol-Myers Squibb in a variety of finance,
strategic, commercial and business development capacities, including CFO and COO
roles for business units in Asia Pacific, Europe and the United States. He
currently serves on the board of directors of PYC Therapeutics. Mr. Haddock
holds a BS in accounting from Illinois State University and an Executive MBA
from Washington University in St. Louis.
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 first quarter of 2024, Merus achieved a
milestone of $1 million for candidate nomination and expects to receive payment
in the second quarter of 2024. This is the fifth program to obtain candidate
nomination under the collaboration.
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.
On April 9, 2024, Merus received U.S. Patent Number 11,952,424 covering our
proprietary Triclonics® format, related to a trispecific antibody comprising a
common light chain, capable of binding at least three different epitopes or
antigens.
Cash Runway, existing cash, cash equivalents and marketable securities expected
to fund Merus' operations into 2027
As of March 31, 2024, Merus had $398.7 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.
First Quarter 2024 Financial Results
We ended the first quarter with cash, cash equivalents and marketable securities
of $398.7 million compared to $411.7 million at December 31, 2023. The decrease
was primarily the result of cash used to fund the operations partially offset by
equity investment from Gilead Sciences.
Collaboration revenue for the three months ended March 31, 2024 decreased by
$5.6 million as compared to the three months ended March 31, 2023, primarily as
a result of lower cost reimbursement revenue.
Research and development expense for the three months ended March 31, 2024
increased by $3.7 million as compared to the three months ended March 31, 2023,
primarily as a result of an increase in clinical and manufacturing costs related
to our programs.
General and administrative expense for the three months ended March 31, 2024
increased by $0.7 million as compared to the three months ended March 31, 2023,
primarily as a result of increases in personnel related costs partially offset
by decrease in facility and consulting costs.
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)
                                                  March 31,      December 31,
                                                    2024             2023
                                                -------------   --------------
                    ASSETS

Current assets:

 Cash and cash equivalents                       $   178,168     $    204,246
 Marketable securities                               159,328          150,130
 Accounts receivable                                  58,726            2,429
 Prepaid expenses and other current assets            14,038           12,009
                                                -------------   --------------
 Total current assets                                410,260          368,814
 Marketable securities                                61,167           57,312
 Property and equipment, net                          11,336           12,135
 Operating lease right-of-use assets                  10,767           11,362
 Intangible assets, net                                1,716            1,800
 Deferred tax assets                                     277            1,199
 Other assets                                          2,560            2,872
                                                -------------   --------------
 Total assets                                    $   498,083     $    455,494
                                                -------------   --------------
     LIABILITIES AND SHAREHOLDERS' EQUITY

Current liabilities:

 Accounts payable                                $     7,488     $      4,602
 Accrued expenses and other liabilities               33,361           38,482
 Income taxes payable                                  1,822            1,646
 Current portion of lease obligation                   1,674            1,674
 Current portion of deferred revenue                  34,142           22,685
                                                -------------   --------------
 Total current liabilities                            78,487           69,089
 Lease obligation                                      9,853           10,488
 Deferred revenue, net of current portion             60,295           19,574
                                                -------------   --------------
 Total liabilities                                   148,635           99,151

Commitments and contingencies - Note 6
Shareholders' equity:
Common shares, EUR0.09 par value; 67,500,000
shares authorized at March 31, 2024 and
December 31, 2023;
58,687,551 and 57,825,879 shares issued and
outstanding as at
March 31, 2024 and December 31, 2023,

 respectively                                          5,968            5,883
 Additional paid-in capital                        1,160,918        1,126,054
 Accumulated other comprehensive income              (29,921 )        (22,533 )
 Accumulated deficit                                (787,517 )       (753,061 )
                                                -------------   --------------
 Total shareholders' equity                          349,448          356,343
                                                -------------   --------------
 Total liabilities and shareholders' equity      $   498,083     $    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
                                                          March 31,
                                               -------------------------------
                                                    2024             2023
                                               --------------   --------------
 Collaboration revenue                          $      7,889     $     13,499
                                               --------------   --------------
 Total revenue                                         7,889           13,499

Operating expenses:

 Research and development                             38,584           34,865
 General and administrative                           16,114           15,386
                                               --------------   --------------
 Total operating expenses                             54,698           50,251
                                               --------------   --------------
 Operating loss                                      (46,809 )        (36,752 )

Other income, net:

 Interest income, net                                  4,917            1,995
 Foreign exchange gains (loss)                         8,534           (5,441 )
                                               --------------   --------------
 Total other income (loss), net                       13,451           (3,446 )
                                               --------------   --------------
 Net loss before income taxes                        (33,358 )        (40,198 )
 Income tax expense                                    1,098             (457 )
                                               --------------   --------------
 Net loss                                       $    (34,456 )   $    (39,741 )
                                               --------------   --------------

Other comprehensive loss:

 Currency translation adjustment                      (7,388 )          4,242
                                               --------------   --------------
 Comprehensive loss                             $    (41,844 )   $    (35,499 )

Net loss per share attributable to common
stockholders:
Basic and diluted $ (0.59 ) $ (0.86 )
Weighted-average common shares outstanding:
Basic and diluted 58,085,416 46,323,772
About Merus N.V.
Merus (https://merus.nl/about/) is a clinical-stage oncology company developing
innovative full-length human bispecific and trispecific antibody therapeutics,
referred to as Multiclonics® (https://merus.nl/technology/multiclonics-
platform/). 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 (https://merus.nl/), and LinkedIn
(https://www.linkedin.com/company/merus).
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 our Zeno through the regulatory, BLA review and
potential commercialization processes; our upcoming presentations of multiple
datasets at ASCO 2024, including the first clinical data on safety and efficacy
of petosemtamab in combination with pembrolizumab in previously untreated head
and neck cancer; our belief we have the opportunity to significantly improve the
lives of patients with both previously treated, as well as newly diagnosed, head
and neck cancer by administration of petosemtamab, and it being a focus of the
Company's resources; 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 with standard chemotherapy in 2L colorectal cancer
patients; 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 belief that obtaining a commercialization partnership
agreement will be an essential step in bringing Zeno to patients with NRG1+
cancer, if approved; 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; our plan to initiate a cohort of MCLA-129 in
combination with chemotherapy in 2L+ EGFRm NSCLC in 2024; 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 March 31, 2024, filed
with the Securities and Exchange Commission, or SEC, on May 8, 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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