On May 7, 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 first quarter and provided a business update (Press release, Merus, MAY 7, 2025, View Source [SID1234652662]).
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"We are very much looking forward to sharing the robust updated interim phase 2 data, on the entire 45 patient data set at 2025 ASCO (Free ASCO Whitepaper). We believe based on these interim data that petosemtamab continues to demonstrate substantial clinical activity superior to historical controls based on the magnitude and consistency of efficacy across ORR, PFS and OS in the overall population and within important subgroups of HPV disease and PD-L1 expression levels," said Bill Lundberg, M.D., President, Chief Executive Officer of Merus. "Additionally, I’m thrilled by the team’s execution in our two phase 3 trials and expect both trials to be substantially enrolled by year end 2025."
Petosemtamab (MCLA-158: EGFR x LGR5 Biclonics): Solid Tumors
LiGeR-HN1 phase 3 trial in 1L recurrent/metastatic (r/m) head and neck squamous cell carcinoma (HNSCC) and LiGeR-HN2 phase 3 trial in 2/3L r/m HNSCC enrolling – with both trials expected to be substantially enrolled by YE25; clinical update on phase 2 trial in combination with pembrolizumab in 1L PD-L1+ HNSCC at 2025 ASCO (Free ASCO Whitepaper); phase 2 trial in 1L, 2L and 3L+ metastatic colorectal cancer (mCRC) enrolling; mCRC initial clinical data planned for 2H25
An updated analysis of the interim clinical data from the phase 2 trial of petosemtamab with pembrolizumab as 1L treatment of PD-L1+ r/m HNSCC will be presented at the 2025 American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) Annual Meeting (ASCO) (Free ASCO Whitepaper) as detailed in our press release, Merus Announces Abstract Accepted for Presentation at the 2025 ASCO (Free ASCO Whitepaper) Annual Meeting. The presentation will include data on the entire 45 patient dataset and follows the early clinical efficacy and encouraging safety data previously presented at 2024 ASCO (Free ASCO Whitepaper), which was detailed in our 2024 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).
Merus will hold a conference call and webcast for investors on Thursday, May 22, 2025 at 5:30 p.m. ET. A replay will be available after the completion of the call in the Investors and Media section of our website for a limited time.
Date & Time: May 22, 2025 at 5:30 p.m. ET
Webcast link: Available on our website
Dial-in: Toll Free: (800) 715-9871 / International: (646) 307-1963
Conference ID: 7517301 or Merus NV call
In February 2025, the U.S. Food and Drug Administration (FDA) granted Breakthrough Therapy designation (BTD) to petosemtamab in combination with pembrolizumab for the first-line treatment of adult patients with recurrent or metastatic programmed death-ligand 1 (PD-L1) positive HNSCC with combined positive score (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). BTD was also granted for petosemtamab monotherapy 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, detailed in our press release, Petosemtamab granted Breakthrough Therapy Designation by the U.S. FDA (May 13, 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).
LiGeR-HN1, a phase 3 trial evaluating the efficacy and safety of petosemtamab in combination with pembrolizumab in 1L PD-L1+ (CPS≥1) r/m HNSCC compared to pembrolizumab, and LiGeR-HN2, a phase 3 trial evaluating the efficacy and safety of petosemtamab in 2/3L HNSCC compared to standard of care, are enrolling and we expect both trials to be substantially enrolled by YE25. Further, the Company manufactures both drug substance and drug product in the United States and Europe, with a plan to focus on potential commercial manufacturing in the United States.
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 for the Company’s phase 3 trial in 1L, and in phase 3 trial in 2/3L HNSCC.
A phase 2 trial evaluating petosemtamab in combination with standard chemotherapy in 1L and 2L mCRC, and as monotherapy in heavily pretreated (3L+) mCRC, is enrolling. 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
Merus has exclusively licensed to Partner Therapeutics, Inc. (PTx) 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
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.
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.
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 March 31, 2025, Merus had $638 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.
First Quarter 2025 Financial Results
Collaboration revenue for the three months ended March 31, 2025 increased by $18.6 million as compared to the three months ended March 31, 2024, primarily as a result of commercial material revenue this quarter and higher deferred revenue amortization.
Research and development expense for the three months ended March 31, 2025 increased by $41.5 million as compared to the three months ended March 31, 2024. The increase is primarily driven by an increase of $35.6 million in clinical trial support provided by contract manufacturing and development organizations and contract research organizations, most of which is related to the petosemtamab clinical trials.
General and administrative expense for the three months ended March 31, 2025 increased by $6.0 million as compared to the three months ended March 31, 2024, primarily as a result of increases in personnel related expenses including share-based compensation of $5.3 million; increases in consulting expenses, facilities and depreciation expense also contributed.
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.
MERUS N.V.
CONDENSED CONSOLIDATED BALANCE SHEETS
(UNAUDITED)
(Amounts in thousands, except share and per share data)
March 31,
2025 December 31,
2024
ASSETS
Current assets:
Cash and cash equivalents $ 197,199 $ 293,294
Marketable securities 261,126 243,733
Accounts receivable 14,203 1,261
Prepaid expenses and other current assets 49,744 30,784
Total current assets 522,272 569,072
Marketable securities 179,886 187,008
Property and equipment, net 10,937 10,770
Operating lease right-of-use assets 9,199 9,254
Intangible assets, net 1,703 1,679
Equity Investment 3,449 —
Deferred tax assets 364 1,520
Other assets 3,112 3,390
Total assets $ 730,922 $ 782,693
LIABILITIES AND SHAREHOLDERS’ EQUITY
Current liabilities:
Accounts payable $ 8,984 $ 4,164
Accrued expenses and other liabilities 42,799 43,957
Income taxes payable 8,015 7,317
Current portion of lease obligation 1,772 1,704
Current portion of deferred revenue 27,560 29,934
Total current liabilities 89,130 87,076
Lease obligation 8,084 8,208
Deferred revenue, net of current portion 37,589 39,482
Total liabilities 134,803 134,766
Commitments and contingencies – Note 6
Shareholders’ equity:
Common shares, €0.09 par value; 105,000,000 shares authorized at March 31, 2025 and December 31, 2024; 69,175,766 and 68,828,749 shares issued and outstanding as at March 31, 2025 and December 31, 2024, respectively 6,990 6,957
Additional paid-in capital 1,686,350 1,664,822
Accumulated other comprehensive income (32,360 ) (55,465 )
Accumulated deficit (1,064,861 ) (968,387 )
Total shareholders’ equity 596,119 647,927
Total liabilities and shareholders’ equity $ 730,922 $ 782,693
MERUS N.V.
CONDENSED CONSOLIDATED STATEMENTS OF OPERATIONS AND COMPREHENSIVE LOSS
(UNAUDITED)
(Amounts in thousands, except share and per share data)
Three Months Ended
March 31,
2025 2024
Commercial material revenue $ 13,331 $ —
Collaboration revenue 13,148 7,889
Royalty revenue 9 —
Total revenue 26,488 7,889
Operating expenses:
Research and development 80,116 38,584
General and administrative 22,112 16,114
Total operating expenses 102,228 54,698
Operating loss (75,740 ) (46,809 )
Other income, net:
Interest income, net 7,203 4,917
Foreign exchange gains (loss) (24,316 ) 8,534
Other expense (1,766 ) —
Total other income (loss), net (18,879 ) 13,451
Net loss before income taxes (94,619 ) (33,358 )
Income tax expense 1,855 1,098
Net loss $ (96,474 ) $ (34,456 )
Other comprehensive loss:
Currency translation adjustment 23,105 (7,388 )
Comprehensive loss $ (73,369 ) $ (41,844 )
Net loss per share attributable to common shareholders:
Basic and diluted $ (1.40 ) $ (0.59 )
Weighted-average common shares outstanding:
Basic and diluted 69,017,576 58,085,416