| Item 7.01 | Regulation FD Disclosure. |
On September 2, 2020, Merus N.V. (the “Company” or “Merus”) posted an updated corporate slide presentation (the “Presentation”) in the “Investors and Media” portion of its website at www.merus.nl including updates to its clinical program for zenocutuzumab (“Zeno”, also known as MCLA-128). A copy of the Presentation is attached as Exhibit 99.1 to this Current Report on Form 8-K.
As set forth in the Presentation, the Company now plans to present efficacy data at a major medical conference in the second quarter of 2021 on more than 30 patients with neuregulin-1 (NRG-1) gene fusion positive (NRG1+) pancreatic, lung and other cancers with the opportunity for four or more months of follow up. At that time, Merus plans to also discuss details of the program and overall strategy. Merus previously expected to provide a clinical update of the Zeno Phase 1/2 eNRGy trial in patients with NRG1+ cancers by the end of the year.
As previously reported, enrollment and clinical operations activities in this trial have continued, albeit at a slower pace, through the COVID-19 pandemic. The decision to revise the timing of the data presentation was made following a recent review of the available dataset, which revealed that trial site restrictions have resulted in not only slower than anticipated enrollment but also insufficient source verification of clinical data required for the presentation of a mature dataset in 2020. Consequently, the Company expects to provide clinical data and a program update at a major medical conference in the second quarter of 2021.
Merus believes that Zeno continues to demonstrate encouraging single agent activity in NRG1+ cancers. Zeno also continues to be well tolerated, which is consistent with previously reported safety data in the overall patient population treated with Zeno monotherapy.
Site activation, patient identification and enrollment, and clinical operations activities have increased since the second quarter of 2020. Thirty clinical trial sites are now open globally, with additional sites being added monthly. Merus expects patient identification and enrollment to continue to accelerate though the Company’s ongoing patient screening and patient identification collaborations.
The Company’s cash, cash equivalents and marketable securities balance as of June 30, 2020 was $197.4 million, as previously reported. Based on Merus’ current operating plan, Merus continues to expect its existing cash, cash equivalents and marketable securities will be sufficient to fund its operations into the second half of 2022.
The information in this Item 7.01 of this Current Report on Form 8-K, including Exhibit 99.1 attached hereto, is intended to be furnished and shall not be deemed “filed” for purposes of Section 18 of the Securities Exchange Act of 1934, as amended (the “Exchange Act”), or otherwise subject to the liabilities of that section, nor shall it be deemed incorporated by reference in any filing under the Securities Act of 1933, as amended, or the Exchange Act, except as expressly set forth by specific reference in such filing. The Company undertakes no obligation to update, supplement or amend the materials attached hereto as Exhibit 99.1.
