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Merus N.V. (Nasdaq: MRUS) is a clinical-stage immuno-oncology company focused on creating innovative therapies to treat and potentially cure cancer. At the heart of Merus' approach is its proprietary Biclonics® and Triclonics® technology platforms, which generate full-length human bispecific and trispecific antibodies. These advanced therapeutics are designed to engage the immune system to kill tumor cells and inhibit tumor cell growth pathways simultaneously.
Core Business
Merus' core business revolves around the discovery and development of bispecific antibody therapeutics. Their flagship technology, Biclonics®, can attack tumors in multiple ways, making them highly effective against various cancer types. The company’s portfolio includes several promising candidates, such as MCLA-128, which targets HER2 and HER3 receptors in gastric and breast cancers; MCLA-117, targeting AML; MCLA-158 (petosemtamab), focused on head and neck squamous cell carcinoma; and MCLA-145, developed for solid tumors.
Latest Achievements and News
As of May 2024, Merus has received the FDA's Breakthrough Therapy Designation (BTD) for petosemtamab in treating patients with recurrent or metastatic head and neck squamous cell carcinoma (HNSCC) that has progressed after treatment with platinum-based chemotherapy and PD-1/PD-L1 antibodies. This significant milestone is based on the promising data from the ongoing phase 1/2 trial of petosemtamab as a monotherapy, showing substantial improvement in clinically significant endpoints. Furthermore, Merus has announced plans to initiate a phase 3 trial in mid-2024 to evaluate the combination of petosemtamab and pembrolizumab in previously untreated patients.
Additionally, Merus revealed the acceptance of abstracts for MCLA-145 and MCLA-129 at the 2024 American Society of Clinical Oncology (ASCO) Annual Meeting. These presentations highlighted the clinical activity of MCLA-145 in advanced solid tumors and the efficacy of MCLA-129 in non-small cell lung cancer (NSCLC).
Financial Condition and Partnerships
Merus has a solid financial foundation, bolstered by strategic partnerships and collaborations. Notably, Merus collaborates with Betta Pharmaceuticals to develop MCLA-129 in China while retaining global rights outside China. The company’s financial strategy includes advancing its clinical development programs and supporting preclinical research and technology development through successful capital raises.
About Merus N.V.
Merus N.V. is dedicated to the development of multispecific antibody therapeutics, referred to as Multiclonics®. These therapeutics have been observed in preclinical and clinical studies to exhibit the same features as conventional human monoclonal antibodies, including long half-life and low immunogenicity. For more information, visit Merus’ official website, Twitter, and LinkedIn.
Merus N.V. (Nasdaq: MRUS) announced the pricing of a public offering of 3,859,650 common shares at $28.50 per share, generating approximately $110.0 million in gross proceeds. The offering, set to close on or about November 9, 2021, includes an option for underwriters to purchase an additional 578,947 shares. The funds will be utilized for advancing clinical development, preclinical research, and general corporate purposes. Jefferies LLC and SVB Leerink LLC are the joint book-running managers for the offering.
Merus N.V. (Nasdaq: MRUS) has announced a proposed underwritten public offering of its common shares to advance its clinical development of innovative bispecific and trispecific antibodies. The offering includes an additional 30-day option for underwriters to purchase 15% more shares. Proceeds will fund clinical and preclinical research, technology development, and working capital. Jefferies LLC and SVB Leerink LLC are the joint managers for this offering, which is contingent on market conditions. The offering follows a previously filed shelf registration statement with the SEC.
Merus N.V. (Nasdaq: MRUS) announced positive developments regarding its zenocutuzumab (Zeno) program after a Type B meeting with the FDA, securing alignment on a potential tumor-agnostic indication. The company shared interim clinical results for its MCLA-158 program at the AACR-NCI-EORTC Conference, with three of seven advanced head and neck cancer patients showing partial responses. Financially, the company reported collaboration revenue of $13.7 million for Q3 2021, up from $8.6 million a year prior, although operating expenses rose significantly. Cash reserves are projected to fund operations into H2 2024.
Merus, a clinical-stage oncology company, presented promising clinical data for its MCLA-158 treatment for advanced head and neck squamous cell carcinoma (HNSCC) during the AACR-NCI-EORTC conference. Out of 10 patients, 3 achieved partial responses and 1 a complete response. In preclinical studies, the Zeno antibody demonstrated a potent ability to block cancer cell growth. The safety profile for MCLA-158 showed infusion reactions as the most common adverse event. Future updates on the MCLA-158 trial are planned for 2022, indicating potential for further therapeutic advancements.
Merus N.V. (Nasdaq: MRUS), a clinical-stage oncology company, announced two poster presentations scheduled for the AACR-NCI-EORTC Virtual Conference on Molecular Targets and Cancer Therapeutics from October 7-10, 2021. The presentations focus on:
- Zenocutuzumab: Targeting HER2/HER3 in cancers with NRG1 fusions.
- MCLA-158: Evaluating antitumor activity in advanced head and neck squamous cell carcinoma.
The posters will be available on demand throughout the conference and on the company's website.
Merus N.V. (Nasdaq: MRUS), a clinical-stage oncology company, announced CEO Bill Lundberg's participation in several upcoming investor conferences. Key events include a panel discussion at Citi’s 16th Annual BioPharma Virtual Conference on September 9, 2021, a pre-recorded presentation at H.C. Wainwright 23rd Annual Global Investment Conference available on September 13, and a presentation at the 2021 Cantor Virtual Global Healthcare on September 27, 2021. The webcasts will be accessible on the company's investor page, with archived presentations available for a limited time.
Merus N.V. (Nasdaq: MRUS) reported its Q2 2021 financial results, with cash and equivalents rising to $352.8 million, expected to fund operations into H2 2024. Collaboration revenue surged to $12.4 million, primarily from Eli Lilly and Incyte. The company shared promising interim results from its Zeno program targeting NRG1 fusion cancers, showing 42% partial response in pancreatic cancer. Ongoing trials for MCLA-158 and MCLA-145 are set for updates in Q4 2021. However, R&D expenses increased, leading to a net loss of $27.4 million for the quarter.
Merus N.V. (Nasdaq: MRUS) announced the novel mechanism of action for its clinical-stage Biclonics® T-cell agonist, MCLA-145, which targets PD-L1 and CD137. Published in Nature Communications, the study reveals MCLA-145's ability to activate immune T cells in tumor microenvironments while blocking inhibitory signals. Currently, MCLA-145 is in a phase 1 multicenter dose escalation study for solid tumors, with Merus retaining U.S. commercialization rights, while Incyte holds rights outside the U.S.
On July 7, 2021, Merus N.V. (Nasdaq: MRUS) announced that CEO Bill Lundberg, M.D. will participate in the panel discussion titled Moving Beyond Monoclonals: The Potential of Multispecific Therapies at William Blair's Biotech Focus Conference 2021. The event is scheduled for July 14 at 11:20 a.m. ET. Investors can access the live webcast on the Company's website, with an archived presentation available for a limited time.
Merus specializes in developing innovative multispecific antibodies, known as Biclonics® and Triclonics®.
Merus has shared interim efficacy data from the phase 1/2 eNRGy trial for zenocutuzumab (Zeno) in patients with NRG1+ cancers, with 61 patients enrolled as of April 13, 2021. Notable findings reveal a 42% overall response rate in pancreatic cancer and a 29% rate across various NRG1+ tumor types. Zeno demonstrates a favorable safety profile, with most adverse events being mild or moderate. The company plans to discuss these results further in an investor call on June 6, 2021.
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