Merus Announces Financial Results for the Third Quarter 2024 and Provides Business Update
Merus N.V. (NASDAQ: MRUS) reported Q3 2024 financial results and business updates. The company's phase 3 trials for petosemtamab in head and neck cancer are progressing, with clinical data updates expected at ESMO Asia in December 2024. The FDA has accepted Zeno BLA for priority review in NRG1+ NSCLC and PDAC cancer. Financial highlights include $782.9 million in cash, cash equivalents, and marketable securities, expected to fund operations into 2028. Q3 collaboration revenue increased by $0.8 million year-over-year, while R&D expenses increased by $26.5 million and G&A expenses rose by $8.2 million.
Merus N.V. (NASDAQ: MRUS) ha riportato i risultati finanziari del terzo trimestre del 2024 e aggiornamenti aziendali. Gli studi clinici di fase 3 per il petosemtamab nel cancro della testa e del collo stanno procedendo, con aggiornamenti sui dati clinici previsti per l'ESMO Asia a dicembre 2024. La FDA ha accettato la Zeno BLA per la revisione prioritaria per il cancro NRG1+ NSCLC e PDAC. I risultati finanziari evidenziano 782,9 milioni di dollari in contante, equivalenti in contante e titoli negoziabili, che si prevede finanzieranno le operazioni fino al 2028. I ricavi da collaborazioni del terzo trimestre sono aumentati di 0,8 milioni di dollari rispetto all'anno precedente, mentre le spese di R&S sono aumentate di 26,5 milioni di dollari e le spese generali e amministrative sono cresciute di 8,2 milioni di dollari.
Merus N.V. (NASDAQ: MRUS) informó sobre los resultados financieros del tercer trimestre de 2024 y actualizaciones empresariales. Los ensayos de fase 3 para el petosemtamab en cáncer de cabeza y cuello están avanzando, con actualizaciones de datos clínicos esperadas en ESMO Asia en diciembre de 2024. La FDA ha aceptado la Zeno BLA para revisión prioritaria en cáncer NRG1+ NSCLC y PDAC. Los aspectos destacados financieros incluyen 782,9 millones de dólares en efectivo, equivalentes de efectivo y valores negociables, que se espera financien las operaciones hasta 2028. Los ingresos por colaboración del tercer trimestre aumentaron en 0,8 millones de dólares interanual, mientras que los gastos de I+D aumentaron en 26,5 millones de dólares y los gastos generales y administrativos crecieron en 8,2 millones de dólares.
Merus N.V. (NASDAQ: MRUS)는 2024년 3분기 재무 결과 및 사업 업데이트를 보고했습니다. 두경부암에 대한 페토세미탐압의 3상 시험이 진행 중이며, 2024년 12월 ESMO 아시아에서 임상 데이터 업데이트가 예정되어 있습니다. FDA는 NRG1+ NSCLC 및 PDAC 암에 대해 Zeno BLA의 우선 심사를 수락했습니다. 재무 하이라이트로는 운영을 2028년까지 지원할 것으로 예상되는 7억8290만 달러의 현금, 현금성 자산 및 유가 증권이 포함됩니다. 3분기 협업 수익은 전년 대비 80만 달러 증가했으며, 연구개발비는 2650만 달러 증가하고, 일반 및 관리비는 820만 달러 증가했습니다.
Merus N.V. (NASDAQ: MRUS) a publié les résultats financiers du troisième trimestre 2024 et des mises à jour commerciales. Les essais de phase 3 pour le petosemtamab dans le cancer de la tête et du cou avancent, avec des mises à jour des données cliniques attendues à l'ESMO Asia en décembre 2024. La FDA a accepté la Zeno BLA pour un examen prioritaire dans le cancer NRG1+ NSCLC et PDAC. Les points saillants financiers incluent 782,9 millions de dollars en liquidités, équivalents de liquidités et titres négociables, qui devraient financer les opérations jusqu'en 2028. Les revenus de collaboration du troisième trimestre ont augmenté de 0,8 million de dollars d'une année sur l'autre, tandis que les dépenses de R&D ont augmenté de 26,5 millions de dollars et les dépenses générales et administratives ont augmenté de 8,2 millions de dollars.
Merus N.V. (NASDAQ: MRUS) hat die finanziellen Ergebnisse für das 3. Quartal 2024 und Unternehmensupdates veröffentlicht. Die Phase-3-Studien für Petosemtamab bei Kopf- und Halskrebs kommen voran, wobei klinische Daten-Updates für Dezember 2024 bei ESMO Asia erwartet werden. Die FDA hat den Zeno BLA zur vorrangigen Prüfung bei NRG1+ NSCLC und PDAC-Krebs angenommen. Zu den finanziellen Eckdaten gehören 782,9 Millionen Dollar in bar, barähnlichen Vermögenswerten und handelbaren Wertpapieren, die voraussichtlich bis 2028 zur Finanzierung der Geschäfte verwendet werden. Die Zusammenarbeitserlöse im 3. Quartal stiegen im Vergleich zum Vorjahr um 0,8 Millionen Dollar, während die F&E-Ausgaben um 26,5 Millionen Dollar und die allgemeinen und Verwaltungskosten um 8,2 Millionen Dollar erhöht wurden.
- Strong cash position of $782.9 million, providing runway into 2028
- FDA acceptance of Zeno BLA for priority review
- Collaboration revenue increased by $0.8 million in Q3 2024 vs Q3 2023
- 67% response rate for petosemtamab with pembrolizumab in 1L r/m HNSCC trial
- Net loss increased to $99.9 million in Q3 2024 from $23.0 million in Q3 2023
- R&D expenses increased by $26.5 million year-over-year
- G&A expenses increased by $8.2 million year-over-year
- Foreign exchange losses of $34.95 million in Q3 2024
Insights
The Q3 2024 results reveal significant operational developments and financial positioning. Key highlights include:
- Strong cash position of
$782.9 million , expected to fund operations into 2028 - Increased R&D expenses by
$26.5 million YoY, reflecting expanded clinical programs - G&A expenses up
$8.2 million YoY due to organizational growth - Net loss widened to
$99.9 million vs$23 million in Q3 2023
The substantial cash runway provides robust operational flexibility for advancing multiple clinical programs. However, increased expenses and wider losses reflect aggressive investment in clinical development, particularly for petosemtamab's phase 3 trials. The collaboration revenue stream remains stable with
The clinical pipeline shows strong progression with multiple potential catalysts. Petosemtamab's development is particularly noteworthy with:
- Two phase 3 trials now enrolling in head and neck cancer
- Promising interim data showing
67% response rate in 1L HNSCC with pembrolizumab combination 37% response rate as monotherapy in 2L+ HNSCC
The FDA priority review acceptance for Zeno in NRG1+ cancers marks a significant regulatory milestone. The company's strategic focus on partnering for MCLA-129 and Zeno commercialization demonstrates a pragmatic approach to resource allocation while maintaining development momentum across the pipeline.
- Phase 3 registrational trials evaluating petosemtamab in combination with pembrolizumab in 1L and petosemtamab monotherapy in 2/3L r/m HNSCC enrolling
- Petosemtamab in 2L+ r/m HNSCC interim clinical data accepted for rapid oral presentation at ESMO® Asia Congress 2024
- 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., Oct. 31, 2024 (GLOBE NEWSWIRE) -- Merus N.V. (Nasdaq: MRUS) (Merus, the Company, we, or our), a clinical-stage oncology company developing innovative, full-length multispecific antibodies (Biclonics® and Triclonics®), today announced financial results for the third quarter and provided a business update.
“I'm encouraged by our continued operational effectiveness, with phase 3 trials accelerating for petosemtamab in both 1L and 2/3L recurrent/metastatic head and neck cancer. I believe petosemtamab has the potential to offer both a first and best in class chemo-free option for these patients,” said Bill Lundberg, M.D., President, Chief Executive Officer of Merus. “We look forward to providing an update on petosemtamab’s monotherapy efficacy, duration and safety in 2L+ HNSCC this December at ESMO® Asia and, in the near future, providing more information on a number of important potential near term catalysts in 2025.”
Petosemtamab (MCLA-158: EGFR x LGR5 Biclonics®): Solid Tumors
LiGeR-HN1 phase 3 trial in 1L head and neck squamous cell carcinoma (HNSCC) and LiGeR-HN2 phase 3 trial in 2/3L HNSCC enrolling; phase 2 trial in 2L metastatic colorectal cancer (mCRC) enrolling; clinical data update on 2L+ HNSCC planned for ESMO® Asia in December 2024
In the third quarter, 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 HNSCC expressing PD-L1 (CPS≥1) 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 r/m HNSCC at the American Society of Clinical Oncology® (ASCO) Annual Meeting 2024, demonstrating a
Merus also provided an interim clinical update on petosemtamab monotherapy in 2L+ HNSCC at the American Association of Cancer Research® (AACR®) Annual Meeting 2023, demonstrating a
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, 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).
Zenocutuzumab (Zeno or MCLA-128: HER2 x HER3 Biclonics®): NRG1 fusion-positive (NRG1+) lung, pancreatic and other solid tumors
Zeno BLA for treatment of NRG1+ non-small cell lung cancer (NSCLC) and pancreatic cancer (PDAC) accepted for priority review by the FDA
The FDA has accepted for priority review a Biologics License Application (BLA) for the bispecific antibody Zeno in patients with NRG1+ NSCLC and PDAC cancer. This acceptance was detailed in our press release Merus Announces U.S. FDA Acceptance and Priority Review of Biologics License Application for Zeno for the Treatment of NRG1+ NSCLC and PDAC (May 6, 2024).
Merus believes that obtaining a commercialization partnership agreement is an important step in bringing Zeno to patients with NRG1+ cancer, if approved.
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, 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 also 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.
MCLA-145 (CD137 x PD-L1 Biclonics®): Solid Tumors
Investigation continues of the phase 1 trial of MCLA-145 in combination with pembrolizumab
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 ongoing at various stages of 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.
Cash Runway, existing cash, cash equivalents and marketable securities expected to fund Merus’ operations into 2028
As of September 30, 2024, Merus had
Third Quarter 2024 Financial Results
Collaboration revenue for the three months ended September 30, 2024 increased by
Research and development expense for the three months ended September 30, 2024 increased by
General and administrative expense for the three months ended September 30, 2024 increased by
Collaboration revenue for the nine months ended September 30, 2024 decreased by
Research and development expense for the nine months ended September 30, 2024 increased by
General and administrative expense for the nine months ended September 30, 2024 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) | ||||||||
| September 30, 2024 | December 31, 2023 | |||||||
| ASSETS | ||||||||
| Current assets: | ||||||||
| Cash and cash equivalents | $ | 432,998 | $ | 204,246 | ||||
| Marketable securities | 199,270 | 150,130 | ||||||
| Accounts receivable | 1,134 | 2,429 | ||||||
| Prepaid expenses and other current assets | 32,874 | 12,009 | ||||||
| Total current assets | 666,276 | 368,814 | ||||||
| Marketable securities | 150,620 | 57,312 | ||||||
| Property and equipment, net | 12,146 | 12,135 | ||||||
| Operating lease right-of-use assets | 10,312 | 11,362 | ||||||
| Intangible assets, net | 1,856 | 1,800 | ||||||
| Deferred tax assets | 838 | 1,199 | ||||||
| Other assets | 2,628 | 2,872 | ||||||
| Total assets | $ | 844,676 | $ | 455,494 | ||||
| LIABILITIES AND SHAREHOLDERS’ EQUITY | ||||||||
| Current liabilities: | ||||||||
| Accounts payable | $ | 6,185 | $ | 4,602 | ||||
| Accrued expenses and other liabilities | 36,279 | 38,482 | ||||||
| Income taxes payable | 4,876 | 1,646 | ||||||
| Current portion of lease obligation | 1,762 | 1,674 | ||||||
| Current portion of deferred revenue | 30,974 | 22,685 | ||||||
| Total current liabilities | 80,076 | 69,089 | ||||||
| Lease obligation | 9,284 | 10,488 | ||||||
| Deferred revenue, net of current portion | 52,055 | 19,574 | ||||||
| Total liabilities | 141,415 | 99,151 | ||||||
| Commitments and contingencies - Note 6 | ||||||||
| Shareholders’ equity: | ||||||||
| Common shares, 68,426,779 and 57,825,879 shares issued and outstanding as at September 30, 2024 and December 31, 2023, respectively | 6,919 | 5,883 | ||||||
| Additional paid-in capital | 1,640,930 | 1,126,054 | ||||||
| Accumulated other comprehensive income | (7,124 | ) | (22,533 | ) | ||||
| Accumulated deficit | (937,464 | ) | (753,061 | ) | ||||
| Total shareholders’ equity | 703,261 | 356,343 | ||||||
| Total liabilities and shareholders’ equity | $ | 844,676 | $ | 455,494 | ||||
| MERUS N.V. CONDENSED CONSOLIDATED STATEMENTS OF OPERATIONS AND COMPREHENSIVE LOSS (UNAUDITED) (Amounts in thousands, except share and per share data) | ||||||||||||||||
| Three Months Ended September 30, | Nine Months Ended September 30, | |||||||||||||||
| 2024 | 2023 | 2024 | 2023 | |||||||||||||
| Collaboration revenue | $ | 11,772 | $ | 11,033 | $ | 26,993 | $ | 35,008 | ||||||||
| Total revenue | 11,772 | 11,033 | 26,993 | 35,008 | ||||||||||||
| Operating expenses: | ||||||||||||||||
| Research and development | 63,239 | 36,810 | 150,942 | 99,973 | ||||||||||||
| General and administrative | 20,765 | 12,591 | 59,466 | 44,040 | ||||||||||||
| Total operating expenses | 84,004 | 49,401 | 210,408 | 144,013 | ||||||||||||
| Operating loss | (72,232 | ) | (38,368 | ) | (183,415 | ) | (109,005 | ) | ||||||||
| Other income, net: | ||||||||||||||||
| Interest income, net | 10,254 | 4,522 | 22,301 | 9,312 | ||||||||||||
| Foreign exchange gains (loss) | (34,950 | ) | 11,952 | (16,897 | ) | 7,062 | ||||||||||
| Total other income (loss), net | (24,696 | ) | 16,474 | 5,404 | 16,374 | |||||||||||
| Net loss before income taxes | (96,928 | ) | (21,894 | ) | (178,011 | ) | (92,631 | ) | ||||||||
| Income tax expense | 2,977 | 1,118 | 6,392 | 2,155 | ||||||||||||
| Net loss | $ | (99,905 | ) | $ | (23,012 | ) | $ | (184,403 | ) | $ | (94,786 | ) | ||||
| Other comprehensive loss: | ||||||||||||||||
| Currency translation adjustment | 31,775 | (10,722 | ) | 15,409 | (6,985 | ) | ||||||||||
| Comprehensive loss | $ | (68,130 | ) | $ | (33,734 | ) | $ | (168,994 | ) | $ | (101,771 | ) | ||||
| Net loss per share attributable to common stockholders: Basic and diluted | $ | (1.46 | ) | $ | (0.43 | ) | $ | (2.94 | ) | $ | (1.91 | ) | ||||
| Weighted-average common shares outstanding: Basic and diluted | 68,254,120 | 53,869,762 | 62,750,425 | 49,532,722 | ||||||||||||
About Merus N.V.
Merus is a clinical-stage 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 ability to successfully advance Zeno through the regulatory, BLA review and potential commercialization processes; our ongoing LiGeR-HN1, LiGeR-HN2 and phase 2 mCRC trials for petosemtamab, our planned update at ESMO Asia in December on the HNSCC 2L+ dose cohort and patients previously reported at AACR 2023; our belief that petosemtamab has the potential to offer both a first and best in class chemo-free option for r/m HNSCC patients; 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; our belief that obtaining a commercialization partnership agreement is an important step in bringing Zeno to patients with NRG1+ cancer, if approved; 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-145 in combination with pembrolizumab; the 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 collaborations between Incyte and Merus, Lilly and Merus, Gilead and Merus, and license agreement between Ono and Merus; and the potential of those collaborations and license 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 September 30, 2024, filed with the Securities and Exchange Commission, or SEC, on October 31, 2024, 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® and Triclonics® are registered trademarks of Merus N.V.
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