Merus Announces Financial Results for the Fourth Quarter and Full Year 2024 and Provides Business Update
Merus (NASDAQ: MRUS) announced financial results and business updates for Q4 and full year 2024. Key highlights include the FDA approval of BIZENGRI® for NRG1+ pancreatic adenocarcinoma and NSCLC patients, and two Breakthrough Therapy designations for petosemtamab.
The company is advancing two Phase 3 trials for petosemtamab: LiGeR-HN1 (in combination with pembrolizumab for 1L PD-L1+ r/m HNSCC) and LiGeR-HN2 (monotherapy in 2/3L r/m HNSCC), both expected to be substantially enrolled by year-end 2025. Interim data showed a 67% response rate in 1L HNSCC combination therapy and 36% response rate in 2L+ monotherapy.
Financial position remains strong with $724.0 million in cash, cash equivalents and marketable securities as of December 31, 2024, expected to fund operations into 2028.
Merus (NASDAQ: MRUS) ha annunciato i risultati finanziari e gli aggiornamenti aziendali per il quarto trimestre e l'intero anno 2024. I punti salienti includono l'approvazione da parte della FDA di BIZENGRI® per pazienti con adenocarcinoma pancreatico NRG1+ e NSCLC, e due designazioni di Terapia Innovativa per petosemtamab.
L'azienda sta portando avanti due studi di Fase 3 per petosemtamab: LiGeR-HN1 (in combinazione con pembrolizumab per 1L PD-L1+ r/m HNSCC) e LiGeR-HN2 (monoterapia in 2/3L r/m HNSCC), entrambi previsti per essere sostanzialmente arruolati entro la fine del 2025. I dati intermedi hanno mostrato un tasso di risposta del 67% nella terapia combinata per HNSCC di 1L e un tasso di risposta del 36% nella monoterapia di 2L+.
La posizione finanziaria rimane solida con $724,0 milioni in contante, equivalenti di cassa e titoli negoziabili al 31 dicembre 2024, previsti per finanziare le operazioni fino al 2028.
Merus (NASDAQ: MRUS) anunció resultados financieros y actualizaciones comerciales para el cuarto trimestre y el año completo 2024. Los aspectos destacados incluyen la aprobación de la FDA de BIZENGRI® para pacientes con adenocarcinoma pancreático NRG1+ y NSCLC, así como dos designaciones de Terapia Innovadora para petosemtamab.
La empresa está avanzando en dos ensayos de Fase 3 para petosemtamab: LiGeR-HN1 (en combinación con pembrolizumab para 1L PD-L1+ r/m HNSCC) y LiGeR-HN2 (monoterapia en 2/3L r/m HNSCC), ambos se espera que estén sustancialmente inscritos para finales de 2025. Los datos interinos mostraron una tasa de respuesta del 67% en la terapia combinada de HNSCC de 1L y una tasa de respuesta del 36% en la monoterapia de 2L+.
La posición financiera sigue siendo sólida con $724,0 millones en efectivo, equivalentes de efectivo y valores negociables al 31 de diciembre de 2024, que se espera financien las operaciones hasta 2028.
Merus (NASDAQ: MRUS)는 2024년 4분기 및 전체 연도 재무 결과와 사업 업데이트를 발표했습니다. 주요 내용으로는 NRG1+ 췌장 선암 및 NSCLC 환자를 위한 BIZENGRI®의 FDA 승인과 petosemtamab에 대한 두 가지 혁신 치료제 지정이 포함됩니다.
회사는 petosemtamab에 대한 두 가지 3상 시험을 진행 중입니다: LiGeR-HN1(1L PD-L1+ r/m HNSCC에 대한 pembrolizumab과의 병용) 및 LiGeR-HN2(2/3L r/m HNSCC에 대한 단독요법)로, 두 시험 모두 2025년 말까지 상당히 등록될 것으로 예상됩니다. 중간 데이터에 따르면, 1L HNSCC 병용 요법에서 67%의 반응률과 2L+ 단독 요법에서 36%의 반응률이 나타났습니다.
재정 상태는 2024년 12월 31일 기준으로 $724.0 백만의 현금, 현금성 자산 및 시장성 유가증권을 보유하고 있어 2028년까지 운영 자금을 지원할 것으로 예상됩니다.
Merus (NASDAQ: MRUS) a annoncé les résultats financiers et les mises à jour commerciales pour le quatrième trimestre et l'année entière 2024. Les points forts incluent l'approbation de la FDA de BIZENGRI® pour les patients atteints d'adénocarcinome pancréatique NRG1+ et de NSCLC, ainsi que deux désignations de Thérapie Innovante pour petosemtamab.
L'entreprise avance dans deux essais de Phase 3 pour petosemtamab : LiGeR-HN1 (en combinaison avec pembrolizumab pour 1L PD-L1+ r/m HNSCC) et LiGeR-HN2 (monothérapie en 2/3L r/m HNSCC), tous deux devant être considérablement inscrits d'ici la fin 2025. Les données intermédiaires ont montré un taux de réponse de 67 % dans la thérapie combinée pour HNSCC de 1L et un taux de réponse de 36 % dans la monothérapie de 2L+.
La position financière reste solide avec $724,0 millions en espèces, équivalents de liquidités et titres négociables au 31 décembre 2024, prévus pour financer les opérations jusqu'en 2028.
Merus (NASDAQ: MRUS) hat die finanziellen Ergebnisse und Geschäftsinformationen für das 4. Quartal und das gesamte Jahr 2024 bekannt gegeben. Zu den wichtigsten Punkten gehört die FDA-Zulassung von BIZENGRI® für NRG1+ Pankreas-Adenokarzinom- und NSCLC-Patienten sowie zwei Durchbruch-Therapie-Bezeichnungen für petosemtamab.
Das Unternehmen führt zwei Phase-3-Studien für petosemtamab durch: LiGeR-HN1 (in Kombination mit Pembrolizumab für 1L PD-L1+ r/m HNSCC) und LiGeR-HN2 (Monotherapie in 2/3L r/m HNSCC), die beide voraussichtlich bis Ende 2025 erheblich eingeschrieben werden. Zwischenzeitliche Daten zeigten eine Ansprechrate von 67 % in der Kombinationstherapie für 1L HNSCC und eine Ansprechrate von 36 % in der Monotherapie für 2L+.
Die finanzielle Lage bleibt stark mit $724,0 Millionen in bar, liquiden Mitteln und handelbaren Wertpapieren zum 31. Dezember 2024, die voraussichtlich die Betriebe bis 2028 finanzieren werden.
- FDA approval of BIZENGRI® for NRG1+ pancreatic cancer and NSCLC
- 67% response rate in 1L HNSCC combination therapy trial
- Two FDA Breakthrough Therapy designations for petosemtamab
- Strong cash position of $724M funding operations into 2028
- Collaboration revenue decreased by $7.8M compared to 2023
- R&D expenses increased by $84.7M year-over-year
- G&A expenses increased by $23.0M year-over-year
Insights
Merus's Q4/FY2024 results showcase a company at an inflection point, transforming from clinical-stage to commercial with significant pipeline momentum and a fortress-like balance sheet. The $724 million cash position providing runway into 2028 represents exceptional financial stability in the biotech sector, allowing Merus to fully execute its clinical programs without near-term financing pressure.
The dual Breakthrough Therapy designations for petosemtamab signal FDA recognition of potentially transformative efficacy. The 67% response rate in 1L PD-L1+ r/m HNSCC with pembrolizumab and 36% response rate in 2L+ r/m HNSCC as monotherapy substantially exceed current standards of care. With both Phase 3 trials expected to be substantially enrolled by YE2025, Merus is executing an accelerated timeline that could support potential submissions in 2026-2027.
December's FDA approval of BIZENGRI for NRG1-fusion cancers marks Merus's first commercial product, validating their Biclonics® platform technology. While commercialization has been licensed to Partner Therapeutics in the U.S., this arrangement allows Merus to maintain focus on pipeline advancement while still benefiting from commercial milestones and royalties.
The $84.7 million increase in R&D expenses reflects appropriate investment scaling to support two pivotal Phase 3 programs and multiple Phase 2 studies. Despite this significant spending increase, the company's cash runway remains exceptionally strong, indicating disciplined capital allocation.
Merus's collaborative business model continues to provide validation and non-dilutive funding. The recent Biohaven partnership for ADC development, following the Gilead collaboration announced in March 2024 ($56M upfront plus $25M equity investment), demonstrates continued interest from larger pharmaceutical companies in Merus's multispecific antibody platforms.
With multiple clinical readouts planned for 2025, including petosemtamab data in both head and neck cancer and colorectal cancer, Merus has several potential value-creating catalysts ahead while maintaining one of the strongest balance sheets among mid-cap oncology companies.
Merus's clinical data for petosemtamab represents potentially practice-changing efficacy in head and neck cancer. The 67% response rate with pembrolizumab in 1L PD-L1+ HNSCC is remarkable when contextualized against the current standard of pembrolizumab monotherapy, which typically achieves only 15-20% response rates in this population. Similarly, the 36% response rate as monotherapy in heavily pretreated 2L+ HNSCC substantially outperforms current options like cetuximab (~10-13% ORR) or single-agent chemotherapy (5-10% ORR).
Petosemtamab's mechanism targeting both EGFR and LGR5 represents a novel approach that may address fundamental limitations of previous EGFR-targeted therapies. By targeting LGR5, a marker of cancer stem cells, petosemtamab potentially eliminates the tumor-initiating cell population responsible for treatment resistance and recurrence - a mechanism that could explain the durable responses observed.
The expansion into colorectal cancer is scientifically rational given that LGR5 is a well-established stem cell marker in intestinal tissue and is frequently overexpressed in CRC. This represents a substantial market opportunity beyond HNSCC, with approximately 150,000 new CRC cases annually in the US alone compared to about 66,000 HNSCC cases.
The BIZENGRI approval marks a significant milestone as the first and only FDA-approved therapy specifically for NRG1 fusion-positive cancers. While this represents an ultra-rare patient population (estimated 0.2-0.5% of NSCLC and pancreatic cancers), the approval validates Merus's bispecific antibody platform and demonstrates their ability to successfully navigate regulatory pathways.
The company's strategy of advancing petosemtamab into multiple tumor types and treatment settings while seeking a partner for MCLA-129 shows appropriate pipeline prioritization. The EGFR x c-MET bispecific approach of MCLA-129 remains scientifically sound for addressing EGFR inhibitor resistance mechanisms, but partnering would allow Merus to focus resources on the more advanced petosemtamab program with its breakthrough designations and potentially near-term approval pathway.
- Phase 3 registrational trials evaluating petosemtamab in combination with pembrolizumab in 1L PD-L1+ r/m HNSCC and petosemtamab monotherapy in 2/3L r/m HNSCC enrolling; expected to be substantially enrolled by YE25
- Petosemtamab in combination with pembrolizumab in 1L PD-L1+ r/m HNSCC phase 2 trial ongoing with clinical data update planned for 1H25
- Petosemtamab evaluation in mCRC ongoing in combination with standard chemotherapy in 1L and 2L and monotherapy in 3L+; mCRC initial clinical data planned for 2H25
- 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., Feb. 27, 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 fourth quarter and full year and provided a business update.
“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®) Annual Meeting 2024, demonstrating a
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
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
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
Full Year 2024 Financial Results
Collaboration revenue for the year ended December 31, 2024 decreased
Research and development expense for the year ended December 31, 2024 increased
General and administrative expense for the year ended December 31, 2024 increased
| 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, | 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.
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 in the 1H 2025 on the phase 2 cohort of 1L r/m PD-L1+ HNSCC; our planned initial clinical data update on the phase 2 investigation of petosemtamab in mCRC; our belief that petosemtamab’s receipt of two BTDs 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; the potential benefits of BTD for petosemtamab’s development, if any; our looking 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; our expectation that the LiGeR-HN1 and LiGeR-HN2 studies 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; 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 in monotherapy in Met ex14 NSCLC, and enrolling of patients in the investigation of MCLA-129 in combination with chemotherapy in 2L+ EGFRm NSCLC; our interest in partnering MCLA-129 to sufficiently resource the development of MCLA-129 and the potential benefit it may have for patients; 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-K for the period ended December 31, 2024, filed with the Securities and Exchange Commission, or SEC, on February 27, 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.
Bizengri®, Multiclonics®, Biclonics®, Triclonics® and ADClonics® are registered trademarks of Merus N.V.
FAQ
What was the response rate for petosemtamab with pembrolizumab in 1L PD-L1+ HNSCC trials?
When will Merus (MRUS) complete enrollment for the Phase 3 petosemtamab trials?
What is MRUS's cash runway as of Q4 2024?
What are the FDA Breakthrough Therapy designations received by MRUS's petosemtamab?
