Merus Announces Financial Results for the Third Quarter and Provides Business Update
– Clinical update of MCLA-129 presented at the 34th EORTC/NCI/AACR (ENA) Symposium on Molecular Targets and Cancer Therapeutics
– Zenocutuzumab (Zeno) Regulatory update: FDA recommends additional enrollment in eNRGy trial to support potential BLA filing
– Clinical update of petosemtamab planned for first half of 2023
“We continue to advance numerous programs which now demonstrate important clinical activity across the portfolio,” said
Zenocutuzumab (Zeno or MCLA-128: HER3 x HER2 Biclonics®): NRG1+ cancer and other solid tumors
Enrollment continues in the eNRGy trial; enrollment in combination study in NRG1+ NSCLC as well as monotherapy in castration resistant prostate cancer (CRPC) planned to begin enrollment in 4Q2022
At the end of October, Merus met with the
Merus is assessing the impact on the timeline for a potential BLA filing for Zeno in NRG1+ cancer. Enrollment continues in the phase 1/2 eNRGy trial to assess the safety and anti-tumor activity of Zeno monotherapy in NRG1+ cancers. Merus believes Zeno has the potential to be a first and best in class and a new standard of care for patients with NRG1+ cancer.
Further, Merus is initiating a clinical trial evaluating Zeno in combination with afatinib for NRG1+ NSCLC, and a clinical trial evaluating Zeno outside of NRG1+ cancer, as a treatment for castration resistant prostate cancer. The Company is also actively exploring the ways in which targeting both HER2 and HER3 with Zeno has potential for the treatment of other cancers.
Petosemtamab (MCLA-158: Lgr5 x EGFR Biclonics®): Solid Tumors
Dose expansion continues in the phase 1 trial: clinical update planned for 1H2023
Petosemtamab is currently enrolling patients with advanced solid tumors in the expansion phase of a phase 1 open-label, multicenter study.
Merus plans to provide a clinical update for petosemtamab at a medical conference in the first half of 2023. The planned presentation will provide the opportunity to present a robust update across the program, including approximately 40 patients with head and neck squamous cell carcinoma (HNSCC) with meaningful clinical follow up, and an update on the gastro-esophageal cohort, to inform clinical development strategy and planned regulatory interactions.
MCLA-145 (CD137 x PD-L1 Biclonics®): Solid Tumors
Phase 1 trial continues including in combination with a PD1 inhibitor
MCLA-145 is currently enrolling a global, phase 1, open-label, single-agent 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 a PD-1 blocking antibody, with first patient dosed and enrollment ongoing.
MCLA-129 (EGFR x c-MET Biclonics®): Solid Tumors
Phase 1 continues with enrollment in expansion cohorts
MCLA-129 is currently enrolling patients in a phase 1/2, open-label clinical trial evaluating patients with MCLA-129 monotherapy in MetEx14 NSCLC, EGFRex20 NSCLC, and in HNSCC, as well as in combination with a third generation EGFR TKI in treatment naïve EGFR mutant (m) NSCLC and in patients with EGFR m NSCLC that have progressed on Tagrisso (osimertinib).
Merus presented initial clinical data regarding MCLA-129 at the 34th EORTC/NCI/AACR (ENA) Symposium. Twenty patients, (14 patients with EGFR m lung cancer, 2 with c-MET exon 14 skipping m NSCLC, 1 patient with c-MET amplified gastric adenocarcinoma, 1 patient with esophageal squamous cell cancer, 2 patients with HNSCC), were treated with MCLA-129 across dose levels of 100 mg-1500 mg. As of an
MCLA-129 is also subject to a collaboration and license agreement with Betta Pharmaceuticals Co. Ltd. (Betta), which permits Betta to exclusively develop MCLA-129 in
Since 2017, Merus has been working together with Incyte Corporation under global collaboration and license agreement, which grants Incyte exclusive rights for up to ten bispecific and monospecific antibody programs from Merus’ Biclonics® platform. The collaboration is progressing, with multiple programs in various stages of preclinical development. Further, Incyte announced this quarter that it plans to start a clinical study of INCA32459, a novel Lag3xPD-1 bispecific antibody developed in collaboration with Merus using Merus’ Biclonics® antibody 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.
Loxo Oncology at Lilly
Cash Runway, Merus expects to be funded beyond 2024
Third Quarter 2022 Financial Results
Collaboration revenue for the three months ended September 30, 2022 decreased by $7.1 million as compared to the three months ended September 30, 2021, primarily as a result of a decrease in Lilly upfront payment amortization and reimbursement revenues and Incyte upfront payment amortization. The change in exchange rates did not significantly impact collaboration revenue.
Research and development expense for the three months ended September 30, 2022 increased by $16.3 million as compared to the three months ended September 30, 2021, primarily as a result of an increase in external clinical services and drug manufacturing costs.
General and administrative expense for the three months ended September 30, 2022 increased by $2.3 million as compared to the three months ended September 30, 2021, primarily as a result of an increase in stock-based compensation expense and consulting costs.
Collaboration revenue for the nine months ended September 30, 2022 decreased by $3.5 million as compared to the nine months ended September 30, 2021, primarily in Lilly upfront payment amortization and reimbursement revenues and Incyte upfront payment amortization.
Research and development expense for the nine months ended September 30, 2022 increased by $29.0 million as compared to the nine months ended September 30, 2021, primarily as a result of an increase in external clinical services and drug manufacturing costs.
General and administrative expense for the nine months ended September 30, 2022 increased by $6.8 million as compared to the nine months ended September 30, 2021, primarily as a result of an increase in stock-based compensation expense, personnel related expenses, and consultancy costs.
Other income (loss), net consists of interest earned and fees paid on our cash and cash equivalents held on account, accretion of investment earnings and net foreign exchange (losses) gains on our foreign denominated cash, cash equivalents and marketable securities. Other gains or losses relate to the issuance and settlement of financial instruments.
CONDENSED CONSOLIDATED BALANCE SHEETS
(Amounts in thousands, except per share data)
|Cash and cash equivalents||$||190,980||$||241,435|
|Accounts receivable (related party)||—||4,609|
|Prepaid expenses and other current assets||14,128||7,448|
|Total current assets||368,199||424,179|
|Property and equipment, net||7,339||3,549|
|Operating lease right-of-use assets||12,345||3,733|
|Intangible assets, net||1,889||2,347|
|Deferred tax assets||435||417|
|LIABILITIES AND STOCKHOLDERS’ EQUITY|
|Accrued expenses and other liabilities||31,190||22,506|
|Income taxes payable||—||—|
|Current portion of lease obligation||1,868||1,494|
|Current portion of deferred revenue||27,975||16,613|
|Current portion of deferred revenue (related party)||—||18,048|
|Total current liabilities||64,150||71,898|
|Deferred revenue, net of current portion||40,790||10,962|
|Deferred revenue, net of current portion (related party)||—||55,282|
|Commitments and contingencies - Note 6|
|Common shares, €0.09 par value; 67,500,000 shares authorized as at
|Additional paid-in capital||864,842||787,869|
|Accumulated other comprehensive income||(54,665||)||(9,221||)|
|Total stockholders’ equity||298,777||316,201|
|Total liabilities and stockholders’ equity||$||414,990||$||456,600|
CONDENSED CONSOLIDATED STATEMENTS OF OPERATIONS AND COMPREHENSIVE LOSS
(Amounts in thousands, except per share data)
|Three Months Ended
||Nine Months Ended
|Collaboration revenue (related party)||—||7,750||—||21,762|
|Research and development||42,307||26,018||100,378||71,436|
|General and administrative||12,469||10,171||36,917||30,073|
|Total operating expenses||54,776||36,189||137,295||101,509|
|Other (loss) income, net:|
|Interest (expense) income, net||866||(25||)||1,288||(158||)|
|Foreign exchange gains (loss)||23,041||7,756||55,378||15,434|
|Other (losses) gains, net||—||(75||)||1,059||(460||)|
|Total other income (loss), net||23,907||7,656||57,725||14,816|
|Net loss before income taxes||(24,288||)||(14,864||)||(48,650||)||(52,295||)|
|Income tax expense||327||(11||)||572||100|
|Other comprehensive loss:|
|Currency translation adjustment||(19,475||)||(5,391||)||(45,444||)||(11,307||)|
|Net loss per share attributable to common stockholders:|
|Basic and diluted||$||(0.53||)||$||(0.39||)||$||(1.11||)||$||(1.39||)|
|Weighted-average common shares outstanding:|
|Basic and diluted||46,057||38,513||44,452||37,708|
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.
Forward Looking Statement
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 updates for our product candidates, including with respect to enrollment and timing of data in our eNRGY trial and Early Access Program, the treatment potential of Zeno and to be potentially first and best in class for NRG1 fusion cancer; our belief in the potential registrational path in NRG1+ cancer tumor agnostic indication or separate applications for NRG1+ lung and NRG1+ pancreatic cancer, which could then be followed by a subsequent potential tumor agnostic filing; the impact of additional enrollment of patients under either approach (tissue agnostic or tumor-type specific), to obtain further supportive data for a potential registrational data set; our understanding of the recent FDA draft guidance on Tissue Agnostic Drug Development in Oncology; our potential filing of a BLA for Zeno in NRG1+ cancer under either a tumor agnostic or tumor specific approach; our assessment of the impact on timeline for a potential BLA filing; the continuation of enrollment of patients in the eNRGY trial to assess the safety and anti-tumor activity of Zeno monotherapy in NRG1+ cancers; future use and potential benefit of Zeno in combination with other cancer therapies; our planned clinical trial evaluating Zeno in combination with afatinib for NRG1+ NSCLC and planned evaluation of Zeno for castration resistant prostate cancer; our exploring the ways in which targeting both HER2 and HER3 with Zeno has potential for the treatment of other cancers; the impact of regulatory interactions on our development of product candidates; statements regarding the sufficiency of our cash, cash equivalents and marketable securities; the advancement of the Phase 1 trial of MCLA-145, as monotherapy and in combination with a PD-1 blocking antibody; 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 a robust update across the program, including approximately 40 patients with HNSCC with meaningful clinical follow up, and an update on the gastro-esophageal cohort, to inform clinical development strategy and planned regulatory interactions; 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 a third generation EGFR TKI in treatment naïve EGFRm NSCLC and in patients with EGFRm NSCLC that have progressed on Tagrisso (osimertinib); the selection of the initial recommended phase 2 dose on the MCLA-129 study; the design and treatment potential of our bispecific antibody candidates and impact of their preclinical data; the benefits of a collaboration between Loxo Oncology at Lilly and Merus, its potential for future value generation; whether any programs under the collaboration will be successful; Merus’ and Lilly’s activities under the agreement; and 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 plans to start a clinical study of INCA32459 developed in collaboration with us; our collaboration and license agreement with Betta, which permits Betta to exclusively develop MCLA-129 in
These and other important factors discussed under the caption “Risk Factors” in our Quarterly Report on Form 10-Q for the period ended
Multiclonics®, Biclonics® and Triclonics® are registered trademarks of Merus N.V.
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