Merus Announces Financial Results for the Second Quarter 2025 and Provides Business Update
Rhea-AI Summary
Merus (NASDAQ:MRUS) reported significant Q2 2025 results and clinical progress. Their lead drug petosemtamab with pembrolizumab showed a 63% response rate in 43 evaluable head and neck cancer patients, with 79% overall survival at 12 months. The company successfully completed a $345M public offering, extending cash runway into 2028 with $892M in cash and equivalents.
Two phase 3 trials for petosemtamab in head and neck cancer are expected to be substantially enrolled by YE25, with potential topline interim readouts in 2026. The drug received Breakthrough Therapy Designation from FDA for first-line PD-L1+ HNSCC treatment. Initial clinical data for colorectal cancer is planned for 2H25.
Q2 financials showed increased R&D expenses of $93.9M, up $44.8M year-over-year, primarily due to clinical trial expansion. Revenue increased by $1.5M compared to Q2 2024, driven by collaboration partnerships.
Positive
- Petosemtamab achieved 63% response rate in 1L HNSCC with 79% overall survival at 12 months
- Successful $345M public offering completed, extending cash runway to 2028
- Strong cash position of $892M as of June 30, 2025
- FDA Breakthrough Therapy Designation received for petosemtamab in 1L PD-L1+ HNSCC
- Multiple revenue-generating partnerships with major pharmaceutical companies
Negative
- R&D expenses increased significantly by $44.8M year-over-year
- Operating loss widened to $110.35M from $64.37M in Q2 2024
- Substantial foreign exchange loss of $51.85M in Q2 2025
Insights
Petosemtamab shows remarkable 63% response rate in head/neck cancer; $892M cash position funds operations into 2028 after successful fundraising.
Merus' clinical data for petosemtamab represents a potential breakthrough in head and neck cancer treatment. The 63% response rate in first-line PD-L1+ recurrent/metastatic HNSCC when combined with pembrolizumab is substantially higher than the 20-25% typically seen with pembrolizumab monotherapy in this setting. The 79% overall survival rate at 12 months is similarly impressive, as current standards of care typically achieve 12-month survival rates of 50-55%.
The FDA's Breakthrough Therapy designations for petosemtamab (both as monotherapy in later lines and in combination with pembrolizumab in first-line) further validate the potential clinical significance. These designations provide enhanced FDA interaction and potentially expedited review.
The company's phase 3 trials are progressing rapidly with expected substantial enrollment completion by year-end 2025 and potential readouts in 2026. If successful, these trials could support both accelerated and regular approval pathways. The 36% response rate as monotherapy in 2L+ HNSCC is also clinically meaningful in a population with limited treatment options.
Merus is expanding petosemtamab's potential with ongoing trials in metastatic colorectal cancer, with initial data expected in 2H 2025. This indication expansion strategy could significantly broaden the commercial opportunity.
The $892 million cash position following their successful $345M raise provides runway into 2028, giving Merus ample resources to complete the phase 3 programs and potentially prepare for commercialization. This strong financial position contrasts with many biotech companies that face funding challenges and provides stability through critical clinical and regulatory milestones.
Strong clinical data driving phase 3 enrollment; $892M cash runway into 2028; R&D expenses rising to support pivotal trials.
Merus' financial position has strengthened considerably following their $345 million public offering, resulting in a robust $892 million cash position as of June 30, 2025. This extended runway into 2028 provides significant operational flexibility and reduces near-term financing risk during a critical phase of clinical development.
R&D expenses increased substantially by $44.8 million (91%) year-over-year for Q2, primarily driven by $37.9 million in increased clinical trial support related to petosemtamab studies. This acceleration in spending reflects the company's transition to late-stage development with two phase 3 trials. While this significantly increases cash burn, it's strategically justified given the compelling clinical data supporting their lead program.
The $20.1 million increase in total revenue for the six-month period compared to 2024 includes $13.3 million from commercial material sales to Partner Therapeutics related to their FDA-approved BIZENGRI®. This validates Merus' bispecific antibody platform while providing non-dilutive capital.
Multiple collaboration agreements with Incyte, Lilly, Gilead, Ono and Biohaven provide further financial validation and potential milestone revenue. During Q2, Merus received a $1 million milestone payment from Incyte for a candidate nomination.
The $76.2 million foreign exchange loss for the six-month period significantly impacted bottom-line results but represents a non-cash accounting impact. Investors should focus on the operational metrics and clinical progress rather than this currency-related fluctuation.
The investment thesis for Merus centers on petosemtamab's clinical profile and commercial potential, with the current valuation primarily reflecting expectations for this lead program. The strong efficacy data in head and neck cancer could position petosemtamab as a potential best-in-class therapy in this indication.
- Petosemtamab in combination with pembrolizumab in 1L PD-L1+ r/m HNSCC phase 2 trial demonstrates 6
- Based on the Company’s current operating plan, existing cash, cash equivalents, including successful public offering raising
UTRECHT, The Netherlands and CAMBRIDGE, Mass., Aug. 05, 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 second quarter and provided a business update.
“We were excited to share the unprecedented efficacy of petosemtamab with pembrolizumab in first-line head and neck cancer at 2025 ASCO®, and were thrilled by the response from clinicians and KOLs, which we believe continues to drive strong phase 3 site activation and support our expectation that both phase 3 trials will be substantially enrolled by year end 2025,” said Bill Lundberg, M.D., President, Chief Executive Officer of Merus. “Additionally, I believe these data substantially enhance the likelihood of clinical success of petosemtamab. We are looking forward to providing initial clinical data on mCRC in the second half of 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 and potential top line interim readout for one or both trials in 2026; phase 2 trial in 1L, 2L and 3L+ metastatic colorectal cancer (mCRC) enrolling; mCRC initial clinical data planned for 2H25
Merus provided updated interim clinical data from the phase 2 trial of petosemtamab with pembrolizumab as 1L treatment for PD-L1+ (CPS≥1) r/m HNSCC at the 2025 American Society of Clinical Oncology® (ASCO®) Annual Meeting, demonstrating a
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, 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.
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. We expect to provide topline interim readout of one or both phase 3 registration trials in 2026.
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 monotherapy in 2L+ r/m HNSCC at the European Society for Medical Oncology Asia Congress, demonstrating a
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. During the second quarter of 2025, Merus received the milestone payment of
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 two 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. The collaboration is progressing well with two programs advancing through preclinical development.
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.
Corporate Activities
Completed public offering raising
This equity raise is detailed in a press release: Merus N.V. Announces Pricing of Public Offering of Common Shares (June 4, 2025).
Cash Runway, existing cash, cash equivalents and marketable securities expected to fund Merus’ operations at least into 2028
As of June 30, 2025, Merus had
Second Quarter 2025 Financial Results
Total revenue for the three months ended June 30, 2025 increased by
Research and development (R&D) expense for the three months ended June 30, 2025 increased by
General and administrative expense for the three months ended June 30, 2025 increased by
Total revenue for the six months ended June 30, 2025 increased by
Research and development expense for the six months ended June 30, 2025 increased by
General and administrative expense for the six months ended June 30, 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) | |||||||
| June 30, 2025 | December 31, 2024 | ||||||
| ASSETS | |||||||
| Current assets: | |||||||
| Cash and cash equivalents | $ | 442,791 | $ | 293,294 | |||
| Marketable securities | 267,433 | 243,733 | |||||
| Accounts receivable | 16,889 | 1,261 | |||||
| Prepaid expenses and other current assets | 41,169 | 30,784 | |||||
| Total current assets | 768,282 | 569,072 | |||||
| Marketable securities | 181,729 | 187,008 | |||||
| Property and equipment, net | 11,346 | 10,770 | |||||
| Operating lease right-of-use assets | 10,320 | 9,254 | |||||
| Intangible assets, net | 1,797 | 1,679 | |||||
| Equity Investment | 2,430 | — | |||||
| Deferred tax assets | 758 | 1,520 | |||||
| Other assets | 3,514 | 3,390 | |||||
| Total assets | $ | 980,176 | $ | 782,693 | |||
| LIABILITIES AND SHAREHOLDERS’ EQUITY | |||||||
| Current liabilities: | |||||||
| Accounts payable | $ | 21,075 | $ | 4,164 | |||
| Accrued expenses and other liabilities | 41,387 | 43,957 | |||||
| Income taxes payable | 478 | 7,317 | |||||
| Current portion of lease obligation | 2,245 | 1,704 | |||||
| Current portion of deferred revenue | 26,394 | 29,934 | |||||
| Total current liabilities | 91,579 | 87,076 | |||||
| Lease obligation | 8,754 | 8,208 | |||||
| Deferred revenue, net of current portion | 38,107 | 39,482 | |||||
| Total liabilities | 138,440 | 134,766 | |||||
| Commitments and contingencies - Note 6 | |||||||
| Shareholders’ equity: | |||||||
| Common shares, | 7,647 | 6,957 | |||||
| Additional paid-in capital | 2,038,795 | 1,664,822 | |||||
| Accumulated other comprehensive income | 18,373 | (55,465 | ) | ||||
| Accumulated deficit | (1,223,079 | ) | (968,387 | ) | |||
| Total shareholders’ equity | 841,736 | 647,927 | |||||
| Total liabilities and shareholders’ equity | $ | 980,176 | $ | 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 June 30, | Six Months Ended June 30, | ||||||||||||||
| 2025 | 2024 | 2025 | 2024 | ||||||||||||
| Commercial material revenue | $ | — | $ | — | $ | 13,331 | $ | — | |||||||
| Collaboration revenue | 8,828 | 7,332 | 21,976 | 15,221 | |||||||||||
| Royalty revenue | — | — | 9 | — | |||||||||||
| Total revenue | 8,828 | 7,332 | 35,316 | 15,221 | |||||||||||
| Operating expenses: | |||||||||||||||
| Research and development | 93,926 | 49,119 | 174,042 | 87,703 | |||||||||||
| General and administrative | 25,252 | 22,587 | 47,364 | 38,701 | |||||||||||
| Total operating expenses | 119,178 | 71,706 | 221,406 | 126,404 | |||||||||||
| Operating loss | (110,350 | ) | (64,374 | ) | (186,090 | ) | (111,183 | ) | |||||||
| Other income, net: | |||||||||||||||
| Interest income, net | 7,122 | 7,130 | 14,325 | 12,047 | |||||||||||
| Foreign exchange gains (loss) | (51,854 | ) | 9,519 | (76,170 | ) | 18,053 | |||||||||
| Other expense | (1,265 | ) | — | (3,031 | ) | — | |||||||||
| Total other income (loss), net | (45,997 | ) | 16,649 | (64,876 | ) | 30,100 | |||||||||
| Net loss before income taxes | (156,347 | ) | (47,725 | ) | (250,966 | ) | (81,083 | ) | |||||||
| Income tax expense | 1,871 | 2,317 | 3,726 | 3,415 | |||||||||||
| Net loss | $ | (158,218 | ) | $ | (50,042 | ) | $ | (254,692 | ) | $ | (84,498 | ) | |||
| Other comprehensive loss: | |||||||||||||||
| Currency translation adjustment | 50,733 | (8,978 | ) | 73,838 | (16,366 | ) | |||||||||
| Comprehensive loss | $ | (107,485 | ) | $ | (59,020 | ) | $ | (180,854 | ) | $ | (100,864 | ) | |||
| Net loss per share attributable to common shareholders: | |||||||||||||||
| Basic and diluted | $ | (2.23 | ) | $ | (0.81 | ) | $ | (3.64 | ) | $ | (1.41 | ) | |||
| Weighted-average common shares outstanding: | |||||||||||||||
| Basic and diluted | 71,096,937 | 61,851,260 | 69,996,121 | 59,968,338 | |||||||||||
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, LinkedIn and Bluesky.
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 initial clinical data update on the phase 2 investigation of petosemtamab in mCRC in the 2H of 2025; 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 and petosemtamab monotherapy for the treatment of patients with recurrent or metastatic HNSCC whose disease has progressed following treatment with platinum based chemotherapy and a PD-1 or PD-L1 antibody; our expectation that the LiGeR-HN1 and LiGeR-HN2 trials will be substantially enrolled by year-end; our expectation of reporting a topline interim readout of one or both phase 3 registration trials in 2026; 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 statements regarding the sufficiency of our cash, cash equivalents and marketable securities, and expectation that it will fund the Company at least 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 June 30, 2025, filed with the Securities and Exchange Commission, or SEC, on August 5, 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. Director Investor Relations and Corporate Communications 617-230-4165 k.farren@merus.nl