On May 6, 2021 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), reported financial results for the first quarter that ended March 31, 2021, and provided a business update (Press release, Merus, MAY 6, 2021, View Source [SID1234579479]).

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"We have made significant progress on our clinical programs this quarter and we are excited to provide a clinical data update on Zeno in an oral presentation at ASCO (Free ASCO Whitepaper) in June, and on MCLA-145 later this year," said Bill Lundberg, M.D., President, Chief Executive Officer of Merus. "In addition we continue to validate our multispecific platforms with our recent value-generating deal with Loxo Oncology at Lilly, progress with our Incyte collaboration and further development of our own pipeline, including the start of clinical development for MCLA-129."

Clinical Programs

Zenocutuzumab (Zeno or MCLA-128: HER3 x HER2 Biclonics)

Oral presentation at the 2021 American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) Annual Meeting
Title: Efficacy and safety of zenocutuzumab in advanced pancreas cancer and other solid tumors harboring NRG1 fusions
Abstract #: 3003
Session Title: Developmental Therapeutics—Molecularly Targeted Agents and Tumor Biology
Session Date and Time: June 4, 2021, 11:00 AM-2:00 PM EDT

We plan to present interim efficacy and safety data from the eNRGy trial and Early Access Program (EAP) of Zeno in patients with NRG1 fusion positive (NRG1+) pancreatic, non-small cell lung and other cancers.

Zeno is currently in the phase 1/2 eNRGy trial to assess the safety and anti-tumor activity of Zeno monotherapy in NRG1+ cancers. We continue to be encouraged by the ongoing trial, observed clinical activity and safety profile and look forward to sharing an interim clinical data update at ASCO (Free ASCO Whitepaper) on June 4.

In the first quarter of 2021, we opened additional clinical trial sites, which are now at more than 35 locations, and we entered into more agreements and collaborations with companies and medical organizations with the goals of raising awareness of the eNRGy trial and providing access to molecular screening opportunities for eligible patients with cancers that may have NRG1 fusions. Merus is now working with more than ten different industry and academic collaborations across Asia, North America and Europe aimed to enhance testing for NRG1 fusions and to raise awareness of the eNRGy trial.

Details of the eNRGy trial can be found at www.ClinicalTrials.gov and Merus’ trial website at www.nrg1.com, or by calling 1-833-NRG-1234.

At the American Association for Cancer Research (AACR) (Free AACR Whitepaper) 2021 Annual Meeting we presented two posters on the mechanism of action of Zeno. Both posters present preclinical data demonstrating that the Dock & Block activity of Zeno can potently inhibit NRG1 (and NRG1 fusion) signaling through HER3:HER2 and tumorigenesis. In addition, a dose dependent inhibition of tumor growth was observed in NRG1 fusion lung and ovarian cancers in a mouse model.

Both posters can be found on our website.

MCLA-158 (Lgr5 x EGFR Biclonics): Solid Tumors

Phase 1 trial continues with dose expansion cohorts

Phase 1 clinical trial of MCLA-158 is ongoing in the dose expansion phase of the open-label, multicenter trial. Enrollment of patients with gastro-esophageal and head-and-neck cancers continues and preliminary evidence of antitumor activity has been observed.

MCLA-145 (CD137 x PD-L1 Biclonics): Solid Tumors

Phase 1 trial clinical data will be presented 2H21

The phase 1, open-label, single-agent clinical trial of MCLA-145 is ongoing and consists of dose escalation followed by dose expansion. MCLA-145 is the first drug candidate co-developed under Merus’ global collaboration and license agreement with Incyte Corporation, which permits the development and commercialization of up to 11 bispecific and monospecific antibodies from the Biclonics platform. Merus has full rights to develop and commercialize MCLA-145 if approved in the United States and Incyte is responsible for its development and commercialization outside the United States.

MCLA-129 (EGFR x c-MET Biclonics): Solid Tumors

First patient dosed in the phase 1/2 trial

Enrollment is on-going in the phase 1/2 dose escalation and expansion trial evaluating MCLA-129 for the treatment of patients with advanced non-small cell lung cancer (NSCLC) and other solid tumors. MCLA-129 is a Biclonics, which binds to EGFR and c-MET and is being investigated for the treatment of solid tumors. EGFR is an important oncogenic driver in many cancers, and upregulation of c-MET signaling has been associated with resistance to EGFR inhibition.

At the American Association for Cancer Research (AACR) (Free AACR Whitepaper) 2021 Annual Meeting, we presented data that demonstrate in preclinical models MCLA-129 blocks EGF and HGF binding to their respective receptors EGFR and c-MET and MCLA-129’s enhanced Fc is capable of potent promotion of antibody-dependent cellular cytotoxicity and antibody-dependent cellular phagocytosis. The data also show MCLA-129 potently inhibits NSCLC tumor growth as monotherapy and in combination with an EGFR TKI and overcomes HGF-mediated EGFR-TKI resistance in preclinical models.

The poster can be found on our website.

Corporate Activities

In May, Merus promoted Cecile Geuijen, Ph.D, to Chief Scientific Officer. Cecile joined Merus twelve years ago as Senior Scientist. Dr. Geuijen has over two decades of experience in discovering and developing antibodies as medicines for clinical evaluation. "We are delighted to have Cecile join our Management Team as CSO," said Bill Lundberg, M.D. CEO of Merus. "She is an outstanding scientist and leader, having a pivotal role in the discovery, design and development of each of Merus’ current clinical-stage assets and many of our preclinical programs." Before joining Merus, Cecile worked on the identification of new therapeutic targets in oncology at Crucell and evaluated new therapeutic targets in oncology at Genmab. She holds a Ph.D. in Biology from the University of Utrecht, was a Marie Curie Fellow at the Duve Institute in Brussels and completed Post-Doctoral studies in cancer biology at the Dutch NKI.

Expanding Collaborations

In January 2021 Merus and Loxo Oncology at Lilly, a research and development group of Eli Lilly and Company (Lilly) announced a research collaboration and exclusive license agreement that will leverage Merus’ proprietary Biclonics platform along with the scientific and rational drug design expertise of Loxo Oncology at Lilly to research and develop up to three CD3-engaging T-cell re-directing bispecific antibody therapies. Merus received an upfront cash payment of $40 million, as well as an equity investment by Lilly of $20 million in Merus common shares. Merus is also eligible to receive up to $540 million in potential development and commercialization milestones per product, for a total of up to approximately $1.6 billion for three products, as well as tiered royalties ranging from the mid-single to low-double digits on product sales should Lilly successfully commercialize a therapy from the collaboration. Under the terms of the agreement, Merus will lead the discovery and early-stage research and Loxo Oncology at Lilly will be responsible for subsequent research, development and commercialization activities.

Cash Runway extended, Merus expects to be funded to at least 2H 2024 through its second follow-on offering and Lilly upfront cash payment and equity investment

On January 21, 2021, Merus successfully priced its second follow-on offering since its 2016 IPO, raising a total of approximately $129.4 million in net proceeds. Based on the Company’s current operating plan, we expect our existing cash, cash equivalents and marketable securities inclusive of the proceeds of $60.0 million from the collaboration with and equity investment by Lilly in January 2021 and aggregate net proceeds from the January follow-on offering will fund Merus’ operations at least into the second half of 2024.

Annual General Meeting and Board of Directors

The Company’s annual general meeting of shareholders (AGM) is planned to be held on May 28, 2021.

First Quarter 2021 Financial Results

We ended the first quarter with cash, cash equivalents and marketable securities of $374.4 million compared to $207.8 million at December 31, 2020. The increase was primarily the result of net proceeds from our follow-on offering and proceeds from the collaboration with and equity investment by Lilly, net of cash used in operations and other items.

Collaboration revenue for the three months ended March 31, 2021 increased by $2 million as compared to the three months ended March 31, 2020, primarily as a result of an increase from a Lilly upfront payment amortization and reimbursement revenues of $1.4 million that commenced in the first quarter, and $0.8 million increases related to Incyte reflecting activities in the period for MCLA-145. The change in exchange rates did not significantly impact collaboration revenue.

Research and development expense for the three months ended March 31, 2021 increased by $3.8 million as compared to the three months ended March 31, 2020, primarily as a result of an increase in external and manufacturing costs related to our programs and stock-based compensation.

General and administrative expense for the three months ended March 31, 2021 increased by $0.4 million as compared to the three months ended March 31, 2020, which is not a significant change and no significant offsetting items in the period.

Other income, net for the three months ended March 31, 2021 was $11.7 million as compared to $3.2 million for the three months ended March 31, 2020. Other income, net consists of interest earned on the Company’s cash and cash equivalents held on account, accretion of investment earnings and net foreign exchange gains on the Company’s foreign denominated cash, cash equivalents and marketable securities.