Merus Announces Financial Results for the Second Quarter and Provides Business Update
“We are encouraged by the interim results on Zeno in patients with NRG1 fusion cancers that we reported in the second quarter and remain focused on successful execution of our Zeno program and our other clinical trials,” said
Zenocutuzumab (Zeno or MCLA-128: HER3 x HER2 Biclonics®)
Phase 2 part of the phase 1/2 trial continues: update planned by the first half of 2022
We shared interim clinical data of our zenocutuzumab (Zeno) program in patients with NRG1 fusion (NRG1+) cancers at the
- As of the
April 13, 2021, efficacy data cutoff, 61 patients with NRG1+ cancer were enrolled, including 45 patients evaluable for response.
- Encouraging early clinical activity was observed, with confirmed partial responses by investigator review (RECIST v1.1) in 42% (5 of 12) patients with pancreatic cancer and in 29% (13 of 45) patients across all NRG1+ tumor types treated.
- One additional partial response was confirmed after the data cutoff date, which if included in the interim efficacy analysis, would increase the percentage of confirmed partial responses across all NRG1+ tumor types treated to 31% (14 of 45 patients).
- More than three quarters (34 of 45) of evaluable patients showed tumor reduction. In addition, 40% (19 of 47) of all patients remained on therapy as of the data cutoff date.
- Zeno continues to be well tolerated with a favorable safety profile.
In the second quarter of 2021, we entered into collaborations with several companies and medical organizations in
MCLA-158 (Lgr5 x EGFR Biclonics®): Solid Tumors
Phase 1 trial continues with dose expansion cohorts: update planned for Q4’21
The phase 1, open-label, multicenter clinical trial of MCLA-158 is ongoing in the dose expansion phase. Enrollment of patients with gastro-esophageal and head-and-neck cancers continues, and preliminary evidence of antitumor activity has been observed. We plan to provide an update at a medical conference in the fourth quarter of 2021.
MCLA-145 (CD137 x PD-L1 Biclonics®): Solid Tumors
Phase 1 trial continues: update planned for Q4’21
The phase 1, open-label, single-agent clinical trial of MCLA-145 is ongoing and consists of a dose escalation phase, to be followed by a planned dose expansion phase. MCLA-145 is the first drug candidate co-developed under Merus’ global collaboration and license agreement with Incyte Corporation (“Incyte”), which permits the development and commercialization of up to 11 bispecific and monospecific antibodies from the Biclonics® platform. Merus retains full rights to develop and commercialize MCLA-145, if approved, in
We published a report in
MCLA-129 (EGFR x c-MET Biclonics®): Solid Tumors
The phase 1/2, open-label, single-agent clinical trial of MCLA-129 is ongoing and consists of a dose escalation phase, to be followed by planned expansion cohorts evaluating MCLA-129 for the treatment of patients with advanced non-small cell lung cancer (NSCLC) and other solid tumors. MCLA-129 is a Biclonics®, which binds to EGFR and c-MET and is being investigated for the treatment of solid tumors. EGFR is an important oncogenic driver in many cancers, and upregulation of c-MET signaling has been associated with resistance to EGFR inhibition.
Second Quarter 2021 Financial Results
We ended the second quarter with cash, cash equivalents and marketable securities of
Collaboration revenue for the three months ended
Research and development expense for the three months ended
General and administrative expense for the three months ended
Collaboration revenue for the six months ended
Research and development expense for the six months ended
General and administrative expense for the six months ended
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||$||311,472||$||163,082|
|Accounts receivable (related party)||2,212||1,623|
|Prepaid expenses and other current assets||10,559||8,569|
|Total current assets||366,994||217,993|
|Property and equipment, net||3,596||4,115|
|Operating lease right-of-use assets||4,762||3,907|
|Intangible assets, net||2,608||2,843|
|Deferred tax assets||140||410|
|LIABILITIES AND STOCKHOLDERS’ EQUITY|
|Accrued expenses and other liabilities||24,529||21,803|
|Income taxes payable||—||206|
|Current portion of lease obligation||1,597||1,432|
|Current portion of deferred revenue||13,184||625|
|Current portion of deferred revenue (related party)||18,937||19,554|
|Total current liabilities||64,407||46,746|
|Deferred revenue, net of current portion||25,338||237|
|Deferred revenue, net of current portion (related party)||67,553||79,450|
|Commitments and contingencies - Note 6|
|Common shares, €0.09 par value; 45,000,000 shares authorized; 38,444,580 and 31,602,953 shares issued and outstanding as at
|Additional paid-in capital||649,627||490,093|
|Accumulated other comprehensive income||3,155||9,071|
|Total stockholders’ equity||219,087||102,263|
|Total liabilities and stockholders’ equity||$||379,583||$||231,217|
CONDENSED CONSOLIDATED STATEMENTS OF OPERATIONS AND COMPREHENSIVE LOSS
(Amounts in thousands, except per share data)
|Three Months Ended
||Six Months Ended
|Collaboration revenue (related party)||7,261||5,872||14,012||11,845|
|Research and development||24,612||13,709||45,418||30,696|
|General and administrative||10,569||8,043||19,902||16,925|
|Total operating expenses||35,181||21,752||65,320||47,621|
|Other (loss) income, net:|
|Interest (expense) income, net||(51||)||99||(133||)||379|
|Foreign exchange (losses) gains, net||(4,525||)||(2,346||)||7,678||539|
|Other (losses) gains, net||52||—||(385||)||—|
|Total other (loss) income, net||(4,524||)||(2,247||)||7,160||918|
|Net loss before income taxes||(27,326||)||(17,943||)||(37,431||)||(34,346||)|
|Income tax expense||62||31||111||128|
|Other comprehensive income (loss):|
|Currency translation adjustment||3,475||2,201||(5,916||)||(906||)|
|Net loss per share attributable to common stockholders:|
|Basic and diluted||$||(0.71||)||$||(0.54||)||$||(1.01||)||$||(1.22||)|
|Weighted-average common shares outstanding:|
|Basic and diluted||38,376||29,034||37,299||28,990|
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 sufficiency of our cash, cash equivalents and marketable securities; the content and timing of potential milestones, updates, guidance, information, clinical trials and data readouts for our product candidates, including with respect to our focus on successful execution of our Zeno program and our other clinical trials; 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, and planned update in the fourth quarter of 2021, the advancement of the phase 1 trial for MCLA-158 and the planned update in the fourth quarter of 2021, and the advancement of the phase 1/2 trial for MCLA-129; the design and treatment potential of our bispecific antibody candidates, clinical study designs, the preclinical data and further advancement of our internal pipeline; the impact and benefit, if any, from increased agreements and collaborations with companies and medical organizations 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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