Merus Announces Financial Results for the Fourth Quarter and Full Year 2021 and Provides Business Update
Clinical data updates planned for lead program Zeno in 1H22 and for petosemtamab (“MCLA-158”) and MCLA-129 in 2H22
Based on the Company’s current operating plan, existing cash, cash equivalents and marketable securities expected to fund Merus’ operations beyond 2024
“We made significant progress in 2021, advancing our clinical programs, further developing our discovery and research pipeline and strengthening our balance sheet,” said Bill Lundberg, M.D., President and Chief Executive Officer of Merus. “Our most advanced product candidate, zenocutuzumab remains on track for a clinical update on the eNRGy trial in the first half of 2022, and, if the rate of enrollment and efficacy remain consistent, we believe a sufficient number of patients will be enrolled in the eNRGy trial and Early Access Program, with sufficient follow up, by mid-2022, that could form the basis of a potential registrational data set. We also plan to provide clinical updates on our second most-advanced candidate, petosemtamab, and on MCLA-129 in the second half of this year.”
Clinical Programs and Business Update
Zenocutuzumab, or “Zeno” (MCLA-128: HER3 x HER2 Biclonics®)
NRG1+ Cancer: Phase 1/2 eNRGy trial clinical data and program update planned for first half of 2022
Zeno is currently being investigated in the phase 1/2 eNRGy trial to assess the safety and anti-tumor activity of Zeno monotherapy in NRG1+ cancer.
Details of the eNRGy trial, including current trial sites, can be found at clinicaltrials.gov and Merus’ trial website at www.nrg1.com, or by calling 1-833-NRG-1234.
Petosemtamab, or “Peto” (MCLA-158: Lgr5 x EGFR Biclonics®): Solid Tumors
Dose expansion continues in the phase 1 trial: update planned for second half of 2022
Peto is currently enrolling in a phase 1 open-label, multicenter study, and is in the expansion phase, in patients with solid tumors.
MCLA-145 (CD137 x PD-L1 Biclonics®): Solid Tumors
Phase 1 trial continues
MCLA-145 is currently enrolling a global, phase 1, open-label, single-agent clinical trial evaluating MCLA-145 in patients with solid tumors. In
Following Incyte’s (Nasdaq: INCY) election to opt-out of its ex-U.S. development of MCLA-145, announced earlier this year, Merus holds global rights to this program. Further clinical evaluation of MCLA-145 is planned, both as monotherapy and in combination with a PD-1 blocking antibody.
MCLA-129 (EGFR x c-MET Biclonics®): Solid Tumors
Dose escalation continues in the phase 1 trial: update planned for the second half of 2022
MCLA-129 is currently enrolling in a phase 1/2, open-label clinical trial consisting of dose escalation followed by a planned dose expansion. Primary objectives of phase 1 are to determine the maximum tolerated dose and/or the recommended phase 2 dose, and the objectives of phase 2 are to evaluate safety, tolerability and potential clinical activity of the recommended phase 2 dose in patients with advanced solid tumors. MCLA-129 is subject to a collaboration and license agreement with Betta Pharmaceuticals Co. Ltd. (Betta), which permits Betta to exclusively develop MCLA-129 in
In the third quarter of 2021 Merus received a milestone payment for achieving pre-clinical candidate nomination of a novel bispecific antibody (target pair program) under the global collaboration and license agreement with Incyte. Candidate nomination has triggered this program’s next phase of IND-enabling studies by Incyte.
Merus receives reimbursement for research activities related to the collaboration and is eligible to receive potential development, regulatory and commercial milestones and sales royalties for any products, if approved.
Loxo Oncology at Lilly
Completed two Public Offerings in 2021
In January and
Shannon Campbell Appointed as Chief Commercial Officer
Cash Runway projected to be beyond 2024
Based on the Company’s current operating plan, Merus expects our existing cash, cash equivalents and marketable securities will fund Merus’ operations beyond 2024.
Full Year 2021 Financial Results
Collaboration revenue for the year ended
Research and development expense for the year ended
General and administrative expense for the year ended
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.
Merus ended 2021 with cash, cash equivalents and marketable securities of
CONSOLIDATED BALANCE SHEETS
(Amounts in thousands except per share data)
|Cash and cash equivalents||$||241,435||$||163,082|
|Accounts receivable (related party)||4,609||1,623|
|Prepaid expenses and other current assets||7,448||8,569|
|Total current assets||424,179||217,993|
|Property and equipment, net||3,549||4,115|
|Operating lease right-of-use assets||3,733||3,907|
|Intangible assets, net||2,347||2,843|
|Deferred tax assets||417||410|
|LIABILITIES AND STOCKHOLDERS’ EQUITY|
|Accrued expenses and other liabilities||22,506||21,803|
|Income taxes payable||—||206|
|Current portion of lease obligation||1,494||1,432|
|Current portion of deferred revenue||16,613||625|
|Current portion of deferred revenue (related party)||18,048||19,554|
|Total current liabilities||71,898||46,746|
|Deferred revenue, net of current portion (related party)||55,282||79,450|
|Commitments and contingencies (Note 10)|
|Common shares, €0.09 par value; 67,500,000 and 45,000,000 shares authorized as at
|Additional paid-in capital||787,869||490,093|
|Accumulated other comprehensive (loss) income||(9,221||)||9,071|
|Total stockholders’ equity||316,201||102,263|
|Total liabilities and stockholders’ equity||$||456,600||$||231,217|
CONSOLIDATED STATEMENTS OF OPERATIONS AND COMPREHENSIVE LOSS
(Amounts in thousands except per share data)
|Collaboration revenue (related party)||29,604||26,580||25,831|
|Research and development||98,187||70,040||55,680|
|General and administrative||40,896||35,781||34,110|
|Total operating expenses||139,083||105,821||89,790|
|Other income (loss), net:|
|Interest (expense) income, net||(129||)||300||1,889|
|Foreign exchange (losses) gains, net||24,663||(9,432||)||1,615|
|Other (losses) gains, net||(1,135||)||—||196|
|Total other income (loss), net||23,399||(9,132||)||3,700|
|Loss before income tax expense||(66,577||)||(85,010||)||(54,957||)|
|Income tax expense||239||503||194|
|Other comprehensive income (loss):|
|Currency translation adjustment||(18,292||)||7,485||(1,308||)|
|Net loss per share allocable to common stockholders:|
|Basic and diluted||$||(1.73||)||$||(2.92||)||$||(2.28||)|
|Weighted-average common shares outstanding:|
|Basic and diluted||38,638,434||29,256,203||24,218,083|
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 updates for our product candidates, including with respect to enrollment and timing of data in our eNRGY trial, the treatment potential of Zeno, the design of the eNRGY clinical trial; our belief that the design and planned enrollment will be appropriate to potentially support a BLA submission seeking a tumor agnostic indication for Zeno in patients with previously treated NRG1+ cancers; our belief that, if the rate of enrollment and efficacy remain consistent, we believe a sufficient number of patients will be enrolled in the eNRGy trial and EAP, with sufficient follow up, by mid-2022, that could form the basis of a potential registrational data set, and 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 1/2 eNRGy trial and planned update by the first half of 2022; the advancement of the Phase 1 trial of MCLA-145, planned, both 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 in second half of 2022; the advancement of the phase 1/2 trial for MCLA-129 and the planned update in second half of 2022; the design and treatment potential of our bispecific antibody candidates and impact of their preclinical data; our global collaboration and license agreement with Incyte, and our eligibility to receive potential development, regulatory and commercial milestones and sales royalties for any products, if approved; our collaboration and exclusive license agreement with Lilly and whether any programs under the collaboration will be successful; 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 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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