Merus Announces Financial Results for the Fourth Quarter and Full Year 2022 and Provides Business Update
– Zenocutuzumab (Zeno) in NRG1+ cancer potential registrational path and timeline update planned for first half of 2023
– Petosemtamab clinical and regulatory update planned for first half of 2023
– MCLA-129 clinical update planned for second half of 2023
– Based on the Company’s current operating plan, existing cash, cash equivalents and marketable securities expected to fund Merus’ operations into second half 2025
“We are making significant progress across our clinical pipeline of important and potentially clinically meaningful new cancer therapeutic candidates, all from our own Biclonics® antibody technologies,” said
Zenocutuzumab (Zeno or MCLA-128: HER2 x HER3 Biclonics®): NRG1+ cancer and other solid tumors
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), and in combination with afatinib in NRG1+ non-small cell lung cancer (NSCLC)
As of year end 2022, over 150 patients with NRG1+ cancer have been treated with Zeno monotherapy in our eNRGy trial and Early Access Program (EAP). Merus plans to provide an update on the potential registrational path and timeline in NRG1+ cancer in the first half of 2023 and a clinical update on Zeno in NRG1+ cancer at a major medical conference in 2023.
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.
Petosemtamab (MCLA-158: EGFR x LGR5 Biclonics®): Solid Tumors
Enrollment continues in dose expansion in the phase 1 trial; clinical update planned for 1H23
Petosemtamab is in clinical development in the expansion part of a phase 1 open-label, multicenter trial in advanced solid tumors, including previously treated head and neck squamous cell carcinoma (HNSCC). Merus previously reported early interim clinical data on petosemtamab in patients with advanced HNSCC at the
Merus plans to provide a clinical update on petosemtamab in the first half of 2023 at a medical conference. The planned update will include data from approximately 40 patients with HNSCC with meaningful clinical follow up, and data from patients with gastro-esophageal cancer, to inform clinical development strategy.
Merus further plans to provide a regulatory path update on petosemtamab in the first half of 2023.
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 EGFRex20 NSCLC, MetEx14 NSCLC, and in HNSCC, as well as MCLA-129 in combination with Tagrisso (osimertinib), 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.
Merus 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
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 consists of a dose escalation phase, followed by a planned dose expansion phase. Merus is also evaluating the combination of MCLA-145 with Keytruda, with enrollment ongoing.
Since 2017, Merus has been working together 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 development. Further, Incyte announced, in 2023, that INCA32459, a novel Lag3xPD-1 bispecific antibody developed through the collaboration is currently being evaluated in clinical studies. In
Loxo Oncology at Lilly
In January 2021, Merus and Loxo Oncology at Lilly, a research and development group of 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 Loxo Oncology at Lilly. The collaboration is progressing with multiple active research programs underway.
Cash Runway, existing cash, cash equivalents and marketable securities expected to fund Merus’ operations into second half 2025
Full Year 2022 Financial Results
Collaboration revenue for the year ended December 31, 2022 decreased $7.5 million as compared to the year ended December 31, 2021, primarily as a result of decreases in Lilly revenue of
Research and development expense for the year ended December 31, 2022 increased $51.2 million as compared to the year ended December 31, 2021, primarily as a result of increases 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 year ended December 31, 2022 increased $11.3 million as compared to the year ended December 31, 2021, primarily as a result increases in stock-based compensation of
Other income, net consists of interest earned on our cash and cash equivalents held on account, accretion of investment earnings and net foreign exchange gains or losses on our foreign denominated cash, cash equivalents and marketable securities, and payables and receivables.
CONSOLIDATED BALANCE SHEETS
(Amounts in thousands except per share data)
|Cash and cash equivalents||$||147,749||$||241,435|
|Accounts receivable (related party)||—||4,609|
|Prepaid expenses and other current assets||12,163||7,448|
|Total current assets||306,443||424,179|
|Property and equipment, net||12,222||3,549|
|Operating lease right-of-use assets||12,618||3,733|
|Intangible assets, net||1,950||2,347|
|Deferred tax assets||2,041||417|
|LIABILITIES AND STOCKHOLDERS’ EQUITY|
|Accrued expenses and other liabilities||35,590||22,506|
|Income taxes payable||2,400||—|
|Current portion of lease obligation||1,684||1,494|
|Current portion of deferred revenue||29,418||16,613|
|Current portion of deferred revenue (related party)||—||18,048|
|Total current liabilities||78,926||71,898|
|Deferred revenue, net of current portion||38,771||10,962|
|Deferred revenue, net of current portion (related party)||—||55,282|
|Commitments and contingencies (Note 10)|
|Common shares, €0.09 par value; 67,500,000 and 67,500,000 shares authorized as at
|Additional paid-in capital||870,874||787,869|
|Accumulated other comprehensive (loss) income||(30,448||)||(9,221||)|
|Total stockholders’ equity||247,055||316,201|
|Total liabilities and stockholders’ equity||$||376,542||$||456,600|
CONSOLIDATED STATEMENTS OF OPERATIONS AND COMPREHENSIVE LOSS
(Amounts in thousands except per share data)
|Collaboration revenue (related party)||—||29,604||26,580|
|Research and development||149,424||98,187||70,040|
|General and administrative||52,200||40,896||35,781|
|Total operating expenses||201,624||139,083||105,821|
|Other income (loss), net:|
|Interest (expense) income, net||2,722||(129||)||300|
|Foreign exchange (losses) gains, net||26,022||24,663||(9,432||)|
|Other (losses) gains, net||1,059||(1,135||)||—|
|Total other income (loss), net||29,803||23,399||(9,132||)|
|Loss before income tax expense||(130,235||)||(66,577||)||(85,010||)|
|Income tax expense||959||239||503|
|Other comprehensive income (loss):|
|Currency translation adjustment||(21,227||)||(18,292||)||7,485|
|Net loss per share allocable to common stockholders:|
|Basic and diluted||$||(2.92||)||$||(1.73||)||$||(2.92||)|
|Weighted-average common shares outstanding:|
|Basic and diluted||44,919,084||38,638,434||29,256,203|
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, www.merus.nl and https://twitter.com/MerusNV.
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, including with respect to enrollment and timing of data in our eNRGy trial and EAP, the treatment potential of Zeno and to be potentially first and best in class for NRG1+ cancer; our belief that multiple registrational paths remain viable, and that the optimal approach is to sequence its development plan by first seeking a potential application for NRG1+ lung and/or pancreatic cancer, which could then be followed by a potential tissue agnostic filing; our understanding of the recent FDA draft guidance; our potential filing of a BLA for Zeno in NRG1+ cancer; the continuation of enrollment of patients in the eNRGy trial to assess the safety and anti-tumor activity of Zeno monotherapy in NRG1+ cancers; our clinical trial evaluating Zeno in combination with afatinib for NRG1+ NSCLC; our clinical trial evaluating Zeno in combination with an ADT as a treatment for CRPC; statements regarding the sufficiency of our cash, cash equivalents and marketable securities, and expectation that it will fund the Company into the second half of 2025; the advancement of the phase 1 trial of MCLA-145, as monotherapy and in combination with Keytruda; the advancement of the phase 1 trial for MCLA-158 and the planned update at a medical conference in the first half of 2023 and opportunity to present an update including approximately 40 patients with HNSCC with meaningful clinical follow up, and an update on patients with gastro-esophageal cancer, and planned a regulatory path update on petosemtamab in the first half of 2023; the advancement of the phase 1/2 trial for MCLA-129 in the dose expansion phase, in monotherapy in MetEx14 NSCLC, EGFRex20 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 Loxo Oncology at Lilly and Merus, its potential for future value generation, including whether and when Merus will receive any future payment under the collaboration, including milestones or royalties, and the amounts of such payments; whether any programs under the collaboration will be successful; Merus’ and Lilly’s activities under the agreement; our global collaboration and license agreement with Incyte, its progress and potential development and commercialization of up to ten bispecific and monospecific antibodies from our Biclonics® platform and Incyte’s clinical study of INCA32459 developed in collaboration with us, including whether and when Merus will receive any future payment under the collaboration, including milestones or royalties, and the amounts of such payments; whether any programs under the collaboration will be successful; our collaboration and license agreement with Betta, which permits Betta to develop MCLA-129 and potentially commercialize exclusively in
These and other important factors discussed under the caption “Risk Factors” in our Annual Report on Form 10-K for the period ended
Multiclonics®, Biclonics® and Triclonics® are registered trademarks of Merus N.V.
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