Merus Announces Financial Results for the Second Quarter 2023 and Provides Business Update
– Petosemtamab granted Fast Track Designation for the treatment of patients with recurrent or metastatic head & neck squamous cell carcinoma
– Phase 3 trial of petosemtamab monotherapy in previously treated (2L/3L) head and neck squamous cell carcinoma planned to initiate in mid-2024
– Zeno granted two Breakthrough Therapy Designations in NRG1 fusion (NRG1+) non-small cell lung and pancreatic cancer
– Based on the Company’s current operating plan, existing cash, cash equivalents and marketable securities expected to fund Merus’ operations into 2026
“Receiving Fast Track Designation is an important milestone for petosemtamab, which we believe further validates its potential to address the unmet need of patients with previously treated recurrent or metastatic head and neck cancer,” said
Petosemtamab (MCLA-158: EGFR x LGR5 Biclonics®): Solid Tumors
Granted Fast Track Designation (FTD) for the treatment of patients with recurrent or metastatic head & neck squamous cell carcinoma (HNSCC), enrollment continues in dose expansion in the phase 1/2 trial with petosemtamab monotherapy in previously treated HNSCC, as well as in combination with Keytruda® (pembrolizumab) as front-line therapy.
Petosemtamab is in clinical development in the expansion part of a phase 1/2 open-label, multicenter trial evaluating petosemtamab monotherapy in patients with advanced solid tumors, including previously treated (recurrent or metastatic) HNSCC. Enrollment is also ongoing in a cohort investigating petosemtamab in combination with Keytruda® in patients with untreated HNSCC to evaluate the safety and clinical activity in this population. Merus plans to report initial interim clinical data from this cohort in the first half of 2024.
Initiation of potential registration-enabling trial
Merus is enrolling up to a total of approximately 40 patients in previously treated (2L/3L) HNSCC with petosemtamab monotherapy at the 1100 or 1500 mg dose levels to confirm a suitable dose for future randomized trials. Based on these data and additional information and analyses, Merus anticipates potentially initiating a randomized phase 3 trial of petosemtamab monotherapy, or investigators’ choice of single agent chemotherapy or cetuximab in 2L/3L HNSCC. Merus anticipates such a trial could potentially start in mid-2024. 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 is also evaluating a phase 3 trial investigating petosemtamab with Keytruda® as a potential front-line therapy for advanced HNSCC expressing PD-L1 (CPS > 1), pending analysis of additional data on the tolerability and safety of the drug combination.
Fast Track Designation
FTD is designed to facilitate the development and expedite the review of drugs to treat serious conditions and fill unmet medical needs.
Interim data from AACR
In April, Merus provided an interim clinical update at the
Zenocutuzumab (Zeno or MCLA-128: HER2 x HER3 Biclonics®): NRG1 fusion (NRG1+) cancer and other solid tumors
Granted Breakthrough Therapy Designation (BTD) for both NRG1+ non-small cell lung cancer (NSCLC) and NRG1+ pancreatic cancer; enrollment continues in the eNRGy trial of Zeno monotherapy in NRG1+ cancer and a phase 2 trial of Zeno in combination with androgen deprivation therapy (ADT) in castration resistant prostate cancer (CRPC); as well as in combination with afatinib in NRG1+ non-small cell lung cancer (NSCLC)
The FDA has granted BTD to Zeno for the treatment of patients with advanced unresectable or metastatic NRG1+ pancreatic cancer following progression with prior systemic therapy or who have no satisfactory alternative treatment options. Additionally, the FDA has granted BTD to Zeno for the treatment of patients with advanced unresectable or metastatic NRG1+ NSCLC, following progression with prior systemic therapy. Zeno is being investigated in the phase 1/2 eNRGy trial and Early Access Program (EAP) which are assessing the safety and anti-tumor activity of Zeno monotherapy in NRG1+ cancer (Phase 1/2: NCT02912949, EAP: NCT04100694).
Merus believes that obtaining a commercialization partnership agreement will be an essential step in bringing Zeno to patients with NRG1+ cancer, if approved.
Merus plans to present a clinical update on Zeno in NRG1+ cancer at the
Further, Merus is evaluating Zeno in combination with an ADT (enzalutamide or abiraterone) in men with CRPC, irrespective of NRG1+ status. Merus plans to provide initial clinical data on Zeno in CRPC in the second half of 2023.
Merus is also evaluating Zeno in combination with afatinib in patients with NRG1+ NSCLC.
MCLA-129 (EGFR x c-MET Biclonics®): Solid Tumors
Enrollment continues in the expansion cohorts in the phase 1/2 trial; clinical update planned for 2H23
MCLA-129 is in clinical development in a phase 1/2, open-label clinical trial evaluating MCLA-129 monotherapy in patients with EGFR ex20 NSCLC, MET ex14 NSCLC, and in HNSCC, as well as MCLA-129 in combination with Tagrisso®, a third generation EGFR TKI, in patients with treatment-naïve EGFR mutant (m) NSCLC and in patients with EGFRm NSCLC that have progressed on Tagrisso®.
In April, Merus provided a pre-clinical presentation of MCLA-129 in comparison with amivantamab at the AACR Annual Meeting 2023. The Company plans to provide an initial clinical data update from the expansion cohorts, and a further clinical development strategy update in the second half of 2023.
MCLA-129 is subject to a collaboration and license agreement with Betta Pharmaceuticals Co. Ltd. (Betta), which permits Betta to develop MCLA-129 and potentially commercialize exclusively in
In July, the
MCLA-145 (CD137 x PD-L1 Biclonics®): Solid Tumors
Enrollment continues in the phase 1 trial, including in combination with Keytruda® (pembrolizumab), a PD-1 inhibitor
MCLA-145 is in clinical development in a global, phase 1, open-label, clinical trial evaluating MCLA-145 in patients with solid tumors. The trial is in the dose expansion phase evaluating the combination of MCLA-145 with Keytruda®, with enrollment ongoing.
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. The agreement grants Incyte certain exclusive rights for up to ten bispecific and monospecific antibody programs. The collaboration is progressing, with multiple programs in various stages of preclinical and clinical development. For each program under the collaboration, Merus receives reimbursement for research activities and is eligible to receive potential development, regulatory and commercial milestones and sales royalties for any products, if approved. Further, Incyte announced, in 2023, that INCA33890, a novel TGFBr2xPD1 bispecific antibody developed through the collaboration is currently being evaluated in clinical studies. In
In January 2021, Merus and
Cash Runway, existing cash, cash equivalents and marketable securities expected to fund Merus’ operations into 2026
Second Quarter 2023 Financial Results
We ended the second quarter with cash, cash equivalents and marketable securities of $311.5 million compared to $326.7 million at December 31, 2022.
Collaboration revenue for the three months ended June 30, 2023 decreased by $2.2 million as compared to the three months ended June 30, 2022, primarily as a result of decreases in reimbursement revenue of
Research and development expense for the three months ended June 30, 2023 decreased by $2.8 million as compared to the three months ended June 30, 2022, primarily as a result of decreases in external clinical services and drug manufacturing costs, including costs to fulfill our obligations under our collaboration agreements, related to our programs of
General and administrative expense for the three months ended June 30, 2023 increased by $3.4 million as compared to the three months ended June 30, 2022, primarily as a result of increases in facilities costs including depreciation of
Collaboration revenue for the six months ended June 30, 2023 decreased by $0.3 million as compared to the six months ended June 30, 2022, primarily as a result of a decrease in reimbursement revenue of
Research and development expense for the six months ended June 30, 2023 increased by $5.1 million as compared to the six months ended June 30, 2022, primarily as a result of increases in personnel related expenses including stock-based compensation of
Other income (loss), net consists of interest earned and fees paid on our cash and cash equivalents held on account, accretion of investment earnings and net foreign exchange (losses) gains on our foreign denominated cash, cash equivalents and marketable securities. Other gains or losses relate to the issuance and settlement of financial instruments.
|CONDENSED CONSOLIDATED BALANCE SHEETS|
|(Amounts in thousands, except per share data)|
|Cash and cash equivalents||$||101,096||$||147,749|
|Prepaid expenses and other current assets||15,243||12,163|
|Total current assets||283,125||306,443|
|Property and equipment, net||13,049||12,222|
|Operating lease right-of-use assets||11,946||12,618|
|Intangible assets, net||1,882||1,950|
|Deferred tax assets||3,057||2,041|
|LIABILITIES AND STOCKHOLDERS’ EQUITY|
|Accrued expenses and other liabilities||31,143||35,590|
|Income taxes payable||1,349||2,400|
|Current portion of lease obligation||1,610||1,684|
|Current portion of deferred revenue||24,151||29,418|
|Total current liabilities||65,849||78,926|
|Deferred revenue, net of current portion||29,202||38,771|
|Commitments and contingencies - Note 6|
|Common shares, €0.09 par value; 67,500,000 shares authorized at
|Additional paid-in capital||948,913||870,874|
|Accumulated other comprehensive income||(26,711||)||(30,448||)|
|Total stockholders’ equity||257,405||247,055|
|Total liabilities and stockholders’ equity||$||363,624||$||376,542|
|CONDENSED CONSOLIDATED STATEMENTS OF OPERATIONS AND COMPREHENSIVE LOSS|
|(Amounts in thousands, except per share data)|
|Three Months Ended
||Six Months Ended
|Research and development||28,298||31,096||63,163||58,071|
|General and administrative||16,063||12,695||31,449||24,448|
|Total operating expenses||44,361||43,791||94,612||82,519|
|Other income, net:|
|Interest income, net||2,795||316||4,790||422|
|Foreign exchange gains (loss)||551||24,607||(4,890||)||32,337|
|Other gains, net||—||601||—||1,059|
|Total other income (loss), net||3,346||25,524||(100||)||33,818|
|Net loss before income taxes||(30,539||)||(5,583||)||(70,737||)||(24,362||)|
|Income tax expense||1,494||131||1,037||245|
|Other comprehensive loss:|
|Currency translation adjustment||(505||)||(19,921||)||3,737||(25,969||)|
|Net loss per share attributable to common stockholders:|
|Basic and diluted||$||(0.66||)||$||(0.13||)||$||(1.52||)||$||(0.56||)|
|Weighted-average common shares outstanding:|
|Basic and diluted||48,321,708||43,636,337||47,328,259||43,781,195|
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, Twitter and LinkedIn.
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; Merus’ belief that receipt of FTD for petosemtamab validates its potential to address the unmet need of patients with previously treated recurrent or metastatic HNSCC; Merus’ belief that the robust clinical data observed in previously treated HNSCC support a phase 3 trial of petosemtamab monotherapy in patients with previously treated head and neck cancer, which could potentially start in mid-2024; the progress to date with the combination of petosemtamab and Keytruda® as potential front-line therapy in advanced head and neck cancer; Merus’ anticipation of potentially initiating a randomized phase 3 trial of petosemtamab monotherapy, or investigators’ choice of single agent chemotherapy or cetuximab in 2L/3L HNSCC; the potential design and details of such a phase 3 trial; 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; Merus’ consideration of conducting a phase 3 trial in front-line therapy in advanced head and neck cancer; the planned interim clinical data update in the first half of 2024 concerning the combination of petosemtamab with Keytruda® in front-line HNSCC; the potential benefits of FTD for petosemtamab and BTD designations for Zeno and the ability of Merus to maintain such designations; Merus’ belief that a obtaining a commercialization partnership agreement will be an essential step in bringing Zeno to patients with NRG1+ cancer, if approved; the planned presentations of Zeno at ESMO 2023; any planned updates on Zeno and NRG1+ cancer, and Zeno in combination with an ADT for the potential treatment of CRPC; statements regarding the sufficiency of our cash, cash equivalents and marketable securities, and expectation that it will fund the Company into 2026; the advancement of the phase 1 trial of MCLA-145, as monotherapy and in combination with Keytruda®; the advancement of the phase 1/2 trial for MCLA-129 in the dose expansion phase, in monotherapy in Met ex14 NSCLC, EGFR ex20 NSCLC, and in HNSCC, as well as in combination with Tagrisso® in treatment naïve EGFRm NSCLC and in patients with EGFRm NSCLC that have progressed on Tagrisso®; the design and treatment potential of our bispecific antibody candidates and impact of their preclinical data; the benefits of the collaboration between
These and other important factors discussed under the caption “Risk Factors” in our Annual Report on Form 10-Q for the period ended
Multiclonics®, Biclonics® and Triclonics® are registered trademarks of Merus N.V.
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Sherri SpearMerus N.V. VP Investor Relations and Corporate Communications 617-821-3246 firstname.lastname@example.org Kathleen FarrenMerus N.V. Investor Relations and Corporate Communications 617-230-4165 email@example.com