Merus Announces Financial Results for the First Quarter 2025 and Provides Business Update
- Strong cash position of $638M expected to fund operations into 2028
- FDA granted Breakthrough Therapy designation for petosemtamab in two indications
- Revenue increased by $18.6M compared to Q1 2024
- Multiple strategic collaborations with major pharmaceutical companies (Incyte, Lilly, Gilead, Ono, Biohaven)
- Net loss widened to $96.47M from $34.46M year-over-year
- R&D expenses increased significantly by $41.5M
- G&A expenses increased by $6.0M
- Foreign exchange losses of $24.32M compared to gains of $8.53M in previous year
Insights
Merus advancing petosemtamab in late-stage trials with breakthrough designations, showing promising response rates while maintaining multiple strategic partnerships.
Merus is making substantial progress with its lead candidate petosemtamab, with two pivotal phase 3 trials in head and neck squamous cell carcinoma (HNSCC) expected to be substantially enrolled by year-end 2025. The FDA has granted Breakthrough Therapy designations for this candidate in both the first-line setting (in combination with pembrolizumab for PD-L1+ HNSCC) and later-line setting (as monotherapy), recognizing its potential clinical importance.
The company will present updated interim phase 2 data for petosemtamab plus pembrolizumab at ASCO 2025, covering the complete 45-patient dataset. Previously reported interim data for petosemtamab monotherapy in later-line HNSCC showed a 36% response rate among 75 evaluable patients - a notable figure for this difficult-to-treat population. Additional exploration in metastatic colorectal cancer is ongoing with initial data expected in 2H 2025.
Merus has achieved a significant regulatory milestone with BIZENGRI® (zenocutuzumab) receiving FDA approval for NRG1 fusion-positive advanced pancreatic cancer and NSCLC. Rather than commercializing independently, Merus has licensed U.S. commercialization rights to Partner Therapeutics while maintaining global rights to other assets.
The company's multispecific antibody platforms continue attracting major pharmaceutical partners. Current collaborations with Incyte, Eli Lilly, Gilead Sciences, Ono Pharmaceutical, and Biohaven provide external validation of Merus' technology while generating revenue streams through research reimbursements and potential milestone payments. These partnerships enhance the company's ability to advance its wholly-owned programs while sharing risk on collaborative projects.
Merus reports 236% revenue increase but widening losses amid accelerated R&D spending, with $638M cash runway into 2028.
Merus' Q1 2025 financial results reveal a company actively investing in late-stage clinical development while maintaining a strong balance sheet. Total revenue reached
Despite revenue growth, operating expenses surged dramatically with R&D expenses more than doubling to
The combination of increased operating expenses and
Merus maintains a solid financial foundation with
The financial data reflects Merus' transition to a more advanced clinical-stage company executing multiple late-stage trials simultaneously. The significant R&D investment demonstrates management's confidence in their pipeline while their substantial cash position provides flexibility to pursue these programs without immediate financing needs.
- Petosemtamab in combination with pembrolizumab in 1L PD-L1+ r/m HNSCC phase 2 trial ongoing with clinical data update at 2025 ASCO® Annual Meeting
- Based on the Company’s current operating plan, existing cash, cash equivalents and marketable securities expected to fund Merus’ operations into 2028
UTRECHT, The Netherlands and CAMBRIDGE, Mass., May 07, 2025 (GLOBE NEWSWIRE) -- 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®), today announced financial results for the first quarter and provided a business update.
“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®. 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®; 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® Annual Meeting (ASCO®) as detailed in our press release, Merus Announces Abstract Accepted for Presentation at the 2025 ASCO® 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®, 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
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
First Quarter 2025 Financial Results
Collaboration revenue for the three months ended March 31, 2025 increased by
Research and development expense for the three months ended March 31, 2025 increased by
General and administrative expense for the three months ended March 31, 2025 increased by
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, | 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 | |||||
About Merus N.V.
Merus is an 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, and LinkedIn.
Forward-Looking Statements
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, regulatory, strategy and development updates for our product candidates; our ongoing LiGeR-HN1, LiGeR-HN2 and phase 2 mCRC trials for petosemtamab, our planned update at 2025 ASCO® on the phase 2 cohort of 1L PD-L1+ r/m HNSCC; our planned initial clinical data update on the phase 2 investigation of petosemtamab in mCRC; the potential impact, if any, on the receipt of BTD by the FDA for petosemtamab in combination with pembrolizumab in 1L PD-L1+ r/m HNSCC; our expectation that the LiGeR-HN1 and LiGeR-HN2 trials will be substantially enrolled by year-end; our belief that 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 our phase 3 trial in 1L, and in phase 3 trial in 2/3L HNSCC; our looking forward to sharing the robust updated interim phase 2 data, on the entire 45 patient data set at 2025 ASCO® ; our belief 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; our statements regarding the sufficiency of our cash, cash equivalents and marketable securities, and expectation that it will fund the Company into 2028; the continued investigation of MCLA-129 and enrolling of patients in the investigation of MCLA-129 in combination with chemotherapy in 2L+ EGFRm NSCLC; the benefits of the license from Merus to PTx for the commercialization of Bizengri® in the US for NRG1+ cancer, collaborations between Incyte and Merus, Lilly and Merus, Gilead and Merus, Biohaven and Merus, and license agreement between Ono and Merus; and the potential of those licenses and collaborations for future value generation, including whether and when Merus will receive any future payments, including milestones or royalties, and the amounts of such payments; whether any programs under the collaboration will be successful; and our collaboration and license agreement with Betta, which permits Betta to develop MCLA-129 and potentially commercialize exclusively in China, while Merus retains full ex-China rights, including any future clinical development by Betta of MCLA-129. These forward-looking statements are based on management’s current expectations. These statements are neither promises nor guarantees, but involve known and unknown risks, uncertainties and other important factors that may cause our actual results, performance or achievements to be materially different from any future results, performance or achievements expressed or implied by the forward-looking statements, including, but not limited to, the following: our need for additional funding, which may not be available and which may require us to restrict our operations or require us to relinquish rights to our technologies or antibody candidates; potential delays in regulatory approval, which would impact our ability to commercialize our product candidates and affect our ability to generate revenue; the lengthy and expensive process of clinical drug development, which has an uncertain outcome; the unpredictable nature of our early stage development efforts for marketable drugs; potential delays in enrollment of patients, which could affect the receipt of necessary regulatory approvals; our reliance on third parties to conduct our clinical trials and the potential for those third parties to not perform satisfactorily; impacts of the volatility in the global economy, including global instability, including the ongoing conflicts in Europe and the Middle East; we may not identify suitable Biclonics® or bispecific antibody candidates under our collaborations or our collaborators may fail to perform adequately under our collaborations; our reliance on third parties to manufacture our product candidates, which may delay, prevent or impair our development and commercialization efforts; protection of our proprietary technology; our patents may be found invalid, unenforceable, circumvented by competitors and our patent applications may be found not to comply with the rules and regulations of patentability; we may fail to prevail in potential lawsuits for infringement of third-party intellectual property; and our registered or unregistered trademarks or trade names may be challenged, infringed, circumvented or declared generic or determined to be infringing on other marks.
These and other important factors discussed under the caption “Risk Factors” in our Quarterly Report on Form 10-Q for the period ended March 31, 2025, filed with the Securities and Exchange Commission, or SEC, on May 7, 2025, and our other reports filed with the SEC, could cause actual results to differ materially from those indicated by the forward-looking statements made in this press release. Any such forward-looking statements represent management’s estimates as of the date of this press release. While we may elect to update such forward-looking statements at some point in the future, we disclaim any obligation to do so, even if subsequent events cause our views to change, except as required under applicable law. These forward-looking statements should not be relied upon as representing our views as of any date subsequent to the date of this press release.
Multiclonics®, Biclonics®, Triclonics®, ADClonics® and BIZENGRI® are registered trademarks of Merus N.V.
Please see full Prescribing Information, including Boxed WARNING, at BIZENGRI.com/pi.
Reference: 1. BIZENGRI. Prescribing information. Merus N.V.; 2024.
Investor and Media Inquiries: Sherri Spear Merus N.V. SVP Investor Relations and Strategic Communications 617-821-3246 s.spear@merus.nl Kathleen Farren Merus N.V. Investor Relations and Corporate Communications 617-230-4165 k.farren@merus.nl
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