On February 27, 2025 Merus N.V. (Nasdaq: MRUS) (Merus, the Company, we, or our), an oncology company developing innovative, full-length multispecific antibodies and antibody drug conjugates (Biclonics, Triclonics and ADClonics), reported financial results for the fourth quarter and full year and provided a business update (Press release, Merus, FEB 27, 2025, View Source [SID1234650727]).
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"We believe that petosemtamab’s receipt of two Breakthrough Therapy designations by the FDA – previously as monotherapy in the 2L+ treatment of r/m HNSCC and very recently, based on updated clinical efficacy, durability and safety of petosemtamab in combination with pembrolizumab in 1L PD-L1+ r/m HNSCC, indicates the potential for these treatment regimens to demonstrate substantial improvement over available therapies," said Bill Lundberg, M.D., President, Chief Executive Officer of Merus. "We look forward to sharing the updated clinical data, including durability, for petosemtamab with pembrolizumab in 1L PD-L1+ r/m HNSCC, for the full phase 2 cohort, in the first half of 2025."
Petosemtamab (MCLA-158: EGFR x LGR5 Biclonics): Solid Tumors
LiGeR-HN1 phase 3 trial in 1L PD-L1+ r/m head and neck squamous cell carcinoma (HNSCC) and LiGeR-HN2 phase 3 trial in 2/3L r/m HNSCC enrolling – we expect both trials to be substantially enrolled by YE25; clinical update on phase 2 trial in combination with pembrolizumab in 1L PD-L1+ r/m HNSCC planned for 1H25; phase 2 trial in 1L, 2L and 3L+ metastatic colorectal cancer (mCRC) enrolling; mCRC initial clinical data planned for 2H25
In February 2025, the U.S. Food and Drug Administration (FDA) granted Breakthrough Therapy designation (BTD) for petosemtamab in combination with pembrolizumab for the first-line treatment of adult patients with r/m PD-L1+ HNSCC with CPS ≥ 1. This designation was detailed in our press release, Petosemtamab granted Breakthrough Therapy designation by the U.S. FDA for 1L PD-L1 positive head and neck squamous cell carcinoma (February 18, 2025).
In September 2024, Merus announced the first patient was dosed in LiGeR-HN1, a phase 3 trial evaluating the efficacy and safety of petosemtamab in combination with pembrolizumab in 1L PD-L1+ r/m HNSCC compared to pembrolizumab. In this trial, patients will be randomized to petosemtamab plus pembrolizumab or pembrolizumab monotherapy. This was detailed in our press release, Merus Announces First Patient Dosed in LiGeR-HN1, a Phase 3 Trial Evaluating Petosemtamab in Combination with Pembrolizumab in 1L r/m HNSCC (September 30, 2024).
Merus provided an interim clinical update on petosemtamab with pembrolizumab in 1L PD-L1+ r/m HNSCC at the American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) Annual Meeting 2024, demonstrating a 67% response rate among 24 evaluable patients. The oral presentation was detailed in our press release, Merus’ Petosemtamab in Combination with Pembrolizumab Interim Data Demonstrates Robust Response Rate and Favorable Safety Profile in 1L r/m HNSCC (May 28, 2024). A clinical update on this cohort is planned for 1H25.
In July 2024, Merus announced the first patient was dosed in LiGeR-HN2, a phase 3 trial evaluating the efficacy and safety of petosemtamab in 2/3L HNSCC compared to standard of care. In this trial, patients will be randomized to petosemtamab monotherapy or investigator’s choice of single agent chemotherapy or cetuximab. This was detailed in our press release, Merus Announces First Patient Dosed in LiGeR-HN2, a Phase 3 Trial Evaluating Petosemtamab in 2/3L r/m HNSCC – Merus (July 24, 2024).
Merus provided updated interim clinical data on petosemtamab in 2L+ r/m HNSCC at the European Society for Medical Oncology Asia Congress, demonstrating a 36% response rate among 75 evaluable patients. The oral presentation was detailed in our press release, Merus’ Petosemtamab Monotherapy Interim Data Continues to Demonstrate Clinically Meaningful Activity in 2L+ r/m HNSCC (Dec. 7, 2024).
In May 2024, the FDA granted BTD for petosemtamab for the treatment of patients with recurrent or metastatic HNSCC whose disease has progressed following treatment with platinum based chemotherapy and an anti-programmed cell death receptor-1 (PD-1) or anti-programmed death ligand 1 (PD-L1) antibody. This designation was detailed in our press release, Petosemtamab granted Breakthrough Therapy Designation by the U.S. FDA (May 13, 2024).
Merus believes a randomized registration trial in HNSCC with an overall response rate endpoint could potentially support accelerated approval and the overall survival results from the same study could potentially verify its clinical benefit to support regular approval.
In the third quarter 2024, Merus announced the first patient was dosed in a phase 2 trial evaluating petosemtamab in combination with standard chemotherapy in 2L mCRC. This was detailed in our press release, Merus Announces First Patient Dosed in Phase 2 Trial of Petosemtamab in 2L CRC (July 8, 2024). In the fourth quarter 2024, Merus announced the first patient was dosed in a phase 2 trial evaluating petosemtamab monotherapy in heavily pretreated (3L+) mCRC. This was detailed in our press release, Merus announces First Patient Dosed in Phase 2 Trial of Petosemtamab in 3L+ mCRC (Dec. 16, 2024). In January 2025, the first patient was dosed in a phase 2 trial evaluating petosemtamab in combination with standard chemotherapy in 1L mCRC. We expect to provide initial clinical data for petosemtamab in mCRC in 2H25.
BIZENGRI (zenocutuzumab-zbco: HER2 x HER3 Biclonics)
Approved by FDA for adults with pancreatic adenocarcinoma or non–small cell lung cancer (NSCLC) that are advanced unresectable or metastatic and harbor a neuregulin 1 (NRG1) gene fusion who have disease progression on or after prior systemic therapy
In December 2024, the FDA approved BIZENGRI (zenocutuzumab-zbco), the first and only treatment indicated for adults with pancreatic adenocarcinoma or NSCLC that are advanced unresectable or metastatic and harbor a NRG1 gene fusion who have disease progression on or after prior systemic therapy. These indications are approved under accelerated approval based on overall response rate (ORR) and duration of response (DOR). Continued approval for these indications may be contingent upon verification and description of clinical benefit in a confirmatory trial(s). BIZENGRI has a Boxed WARNING for Embryo-Fetal Toxicity and warnings for infusion-related reactions (IRRs), hypersensitivity and anaphylactic reactions, interstitial lung disease (ILD)/pneumonitis, and left ventriculardysfunction.1 See Important Safety Information below. This was detailed in our press release, Merus Announces FDA Approval of BIZENGRI (zenocutuzumab-zbco) for NRG1+ Pancreatic Adenocarcinoma and NRG1+ Non–Small Cell Lung Cancer (NSCLC) Based on Safety and Efficacy Data From the eNRGy Study (December 4, 2024).
Merus has exclusively licensed to Partner Therapeutics the right to commercialize BIZENGRI for the treatment of NRG1+ cancer in the U.S. This was detailed in our press release, Merus and Partner Therapeutics Announce License Agreement for the U.S. Commercialization of Zenocutuzumab in NRG1 Fusion-Positive Cancer (December 2, 2024).
MCLA-129 (EGFR x c-MET Biclonics): Solid Tumors
Investigation of MCLA-129 is ongoing in METex14 NSCLC; phase 2 trial in combination with chemotherapy in 2L+ EGFR mutant (EGFRm) NSCLC enrolling
In the third quarter 2024, Merus announced the first patients were dosed in the phase 2 trial evaluating MCLA-129 in combination with chemotherapy in 2L+ EGFRm NSCLC, with a cohort receiving MCLA-129 and paclitaxel and carboplatin, and another cohort receiving MCLA-129 and docetaxel. We remain interested in partnering MCLA-129 to sufficiently resource the development of MCLA-129 and the potential benefit it may have for patients.
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 China, while Merus retains global rights outside of China.
Collaborations
Incyte Corporation
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. 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.
Eli Lilly and Company
In January 2021, Merus and 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 Lilly. The collaboration is progressing well with three programs advancing through preclinical development.
Gilead Sciences
In March 2024, Merus and Gilead Sciences announced a collaboration to discover novel antibody based trispecific T-cell engagers using Merus’ patented Triclonics platform. Under the terms of the agreement, Merus will lead early-stage research activities for two programs, with an option to pursue a third. Gilead will have the right to exclusively license programs developed under the collaboration after the completion of select research activities. If Gilead exercises its option to license any such program from the collaboration, Gilead will be responsible for additional research, development and commercialization activities for such program. Merus received an equity investment by Gilead of $25 million in Merus common shares and an upfront payment of $56 million.
Ono Pharmaceutical
In 2018, the Company granted Ono Pharmaceutical Co., Ltd. (Ono) an exclusive, worldwide, royalty-bearing license, with the right to sublicense, research, test, make, use and market a limited number of bispecific antibody candidates based on Merus’ Biclonics technology platform directed to an undisclosed target combination. During the third quarter of 2024, Merus achieved and received a milestone payment based on the filing of an Investigational New Drug (IND) application in Japan.
Biohaven
In January 2025, Merus and Biohaven announced a research collaboration and license agreement to co-develop three novel bispecific antibody drug conjugates (ADCs), leveraging Merus’ leading Biclonics technology platform, and Biohaven’s next-generation ADC conjugation and payload platform technologies. Under the terms of the agreement, Biohaven is responsible for the preclinical ADC generation of three Merus bispecific antibodies under mutually agreed research plans. The agreement includes two Merus bispecific programs generated using the Biclonics platform, and one program under preclinical research by Merus. Each program is subject to mutual agreement for advancement to further development, with the parties then sharing subsequent external development costs and commercialization, if advanced.
Cash Runway, existing cash, cash equivalents and marketable securities expected to fund Merus’ operations into 2028
As of December 31, 2024, Merus had $724.0 million cash, cash equivalents and marketable securities. Based on the Company’s current operating plan, the existing cash, cash equivalents and marketable securities are expected to fund Merus’ operations into 2028.
Full Year 2024 Financial Results
Collaboration revenue for the year ended December 31, 2024 decreased $7.8 million as compared to the year ended December 31, 2023, primarily as a result of decreases in Lilly revenue of $8.4 million and Incyte revenue of $6.4 million, offset by increases in Gilead revenue of $4.8 million, and Other revenue of $2.2 million. The decrease in Lilly revenue is primarily the result of decreases in upfront payment amortization of $4.8 million and reimbursement revenue of $3.6 million. The decrease in Incyte revenue is primarily the result of decreases in milestone revenue of $5.0 million and reimbursement revenue of $1.4 million. Gilead revenue increased due to the start of the collaboration agreement in 2024 which resulted in an increase in upfront payment amortization of $4.8 million. The increase in Other revenue is primarily the result of increases in milestone revenue of $2.1 million.
Research and development expense for the year ended December 31, 2024 increased $84.7 million as compared to the year ended December 31, 2023, primarily as a result of increases in external clinical services and drug manufacturing costs of $66.6 million, which primarily includes costs to advance our petosemtamab program and costs to fulfill our obligations under our collaboration agreements related to our programs, increases in personnel related expenses including share-based compensation of $11.8 million due to an increase in employee headcount and an increase in share price, consultancy expenses of $5.5 million, facilities expenses and other related expenses of $0.7 million, and consumables expenses of $0.2 million, offset by decreases in depreciation and amortization of $0.1 million.
General and administrative expense for the year ended December 31, 2024 increased $23.0 million as compared to the year ended December 31, 2023, primarily as a result of increases in personnel related expenses including share-based compensation of $12.6 million due to an increase in employee headcount and an increase in share price, consultancy expenses of $6.8 million, legal expenses of $1.8 million, facilities and depreciation expense of $1.2 million, and intellectual property and licenses expenses of $0.7 million. 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.
MERUS N.V.
CONSOLIDATED BALANCE SHEETS
(Amounts in thousands, except share and per share data)
2024 2023
ASSETS
Current assets:
Cash and cash equivalents $ 293,294 $ 204,246
Marketable securities 243,733 150,130
Accounts receivable 1,261 2,429
Prepaid expenses and other current assets 30,784 12,009
Total current assets 569,072 368,814
Marketable securities 187,008 57,312
Property and equipment, net 10,770 12,135
Operating lease right-of-use assets 9,254 11,362
Intangible assets, net 1,679 1,800
Deferred tax assets 1,520 1,199
Other assets 3,390 2,872
Total assets $ 782,693 $ 455,494
LIABILITIES AND SHAREHOLDERS’ EQUITY
Current liabilities:
Accounts payable $ 4,164 $ 4,602
Accrued expenses and other liabilities 43,957 38,482
Income taxes payable 7,317 1,646
Current portion of lease obligation 1,704 1,674
Current portion of deferred revenue 29,934 22,685
Total current liabilities 87,076 69,089
Lease obligation 8,208 10,488
Deferred revenue, net of current portion 39,482 19,574
Total liabilities 134,766 99,151
Commitments and contingencies (Note 10)
Shareholders’ equity:
Common shares, €0.09 par value; 105,000,000 and 67,500,000 shares authorized at December 31, 2024 and 2023, respectively; 68,828,749 and 57,825,879 shares issued and outstanding at December 31, 2024 and 2023, respectively 6,957 5,883
Additional paid-in capital 1,664,822 1,126,054
Accumulated deficit (968,387 ) (753,061 )
Accumulated other comprehensive (loss) income (55,465 ) (22,533 )
Total shareholders’ equity 647,927 356,343
Total liabilities and shareholders’ equity $ 782,693 $ 455,494
MERUS N.V.
CONSOLIDATED STATEMENTS OF OPERATIONS AND COMPREHENSIVE LOSS
(Amounts in thousands, except share and except per share data)
Year Ended December 31,
2024 2023 2022
Collaboration revenue $ 36,133 43,947 41,586
Total revenue 36,133 43,947 41,586
Operating expenses:
Research and development 225,368 140,658 149,424
General and administrative 82,832 59,836 52,200
Total operating expenses 308,200 200,494 201,624
Operating loss (272,067 ) (156,547 ) (160,038 )
Other income (loss), net:
Interest (expense) income, net 30,789 14,510 2,722
Foreign exchange (losses) gains, net 34,103 (9,710 ) 26,022
Other (losses) gains, net — — 1,059
Total other income (loss), net 64,892 4,800 29,803
Loss before income tax expense (207,175 ) (151,747 ) (130,235 )
Income tax expense 8,151 3,192 959
Net loss $ (215,326 ) $ (154,939 ) $ (131,194 )
Other comprehensive income (loss):
Currency translation adjustment (32,932 ) 7,915 (21,227 )
Comprehensive loss $ (248,258 ) $ (147,024 ) $ (152,421 )
Net loss per share allocable to common shareholders:
Basic and diluted $ (3.35 ) $ (3.00 ) $ (2.92 )
Weighted-average common shares outstanding:
Basic and diluted 64,220,765 51,605,444 44,919,084
Please see full Prescribing Information, including Boxed WARNING, at BIZENGRI.com/pi.
Reference: 1. BIZENGRI. Prescribing information. Merus N.V.; 2024.