Merus Announces Financial Results for the Third Quarter 2024 and Provides Business Update
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 TumorsLiGeR-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 67% response rate among 24 evaluable patients. The oral presentation was detailed in our 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 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 37% response rate among 43 evaluable patients. The oral presentation was detailed in our press release (April 17, 2023). Merus plans to provide updated efficacy, durability and safety data of this cohort along with clinical data from the dose optimization cohort evaluating petosemtamab monotherapy 1500 or 1100 mg dose levels in 2L+HNSCC. This was detailed in our press release, Merus Announces Abstract Accepted for Presentation at the ESMO Asia Congress 2024 (September 17, 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, 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 tumorsZeno 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 TumorsInvestigation 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 CorporationSince 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 CompanyIn 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 SciencesIn 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 $25 million in Merus common shares and an upfront payment of $56 million.
Ono PharmaceuticalIn 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 $782.9 million cash, cash equivalents and marketable securities. Based on the Company's current operating plan, the existing cash, cash equivalents and marketable securities are expected to fund Merus' operations into 2028.
Third Quarter 2024 Financial Results
Collaboration revenue for the three months ended September 30, 2024 increased by $0.8 million as compared to the three months ended September 30, 2023, primarily as a result of increases in amortization of upfront deferred revenue. The change in exchange rates did not significantly impact collaboration revenue.
Research and development expense for the three months ended September 30, 2024 increased by $26.5 million as compared to the three months ended September 30, 2023, primarily as a result of increases in external clinical services and drug manufacturing expenses.
General and administrative expense for the three months ended September 30, 2024 increased by $8.2 million as compared to the three months ended September 30, 2023, primarily as a result of increases in personnel related expenses, facilities, depreciation expense and consulting expenses.
Collaboration revenue for the nine months ended September 30, 2024 decreased by $8.0 million as compared to the nine months ended September 30, 2023, primarily as a result of decreases in milestone revenue and amortization of deferred revenue.
Research and development expense for the nine months ended September 30, 2024 increased by $51.0 million as compared to the nine months ended September 30, 2023, primarily as a result of increases in external clinical services and drug manufacturing expenses.
General and administrative expense for the nine months ended September 30, 2024 increased by $15.5 million as compared to the nine months ended September 30, 2023, primarily as a result of increases in personnel related expenses and consulting expenses.
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
