On March 29, 2022 Monte Rosa Therapeutics, Inc. (NASDAQ: GLUE), a biotechnology company developing novel molecular glue degrader (MGD) medicines, reported business highlights and financial results for the fourth quarter and full year, ended December 31, 2021 (Press release, Monte Rosa Therapeutics, MAR 29, 2022, View Source [SID1234611090]).
Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:
Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing
Schedule Your 30 min Free Demo!
"Last year was transformational for Monte Rosa as we continued to build our world-class leadership team, expanded operations across our two sites in Boston and Basel, named MRT-2359 – our development candidate for the GSPT1 program – and secured $377.6 million in funding," said Markus Warmuth, M.D., CEO of Monte Rosa. "As we look to 2022, we anticipate significant pipeline progress, including the submission of our IND for MRT-2359, as well as continued lead optimization on our CDK2 and NEK7 programs. We are also seeing exciting advancements across our proprietary QuEEN platform, including the expansion of our understanding of structural characteristics of degradable proteins driven by both our experimental and AI platforms. We believe we are well-positioned both organizationally and financially to execute on our vision of tackling historically undruggable targets and identifying potent, highly selective therapies for patients with few or no treatment options."
FOURTH QUARTER 2021 & RECENT HIGHLIGHTS
•Presented preclinical data for MRT-2359 demonstrating anti-tumor activity in L- and N-Myc-positive non-small cell lung cancer patient-derived xenograft (PDX) models. The data were featured as part of the company’s presentation at the 40th Annual J.P. Morgan Healthcare Conference. MRT-2359 is a potent, selective and orally bioavailable GSPT1-directed molecular glue degrader. MRT-2359 has been shown to induce tumor regression in multiple Myc-driven preclinical models, including models of non-small cell lung cancer and small cell lung cancer
•Advanced CDK2 degrader program into lead optimization. Leveraging the company’s QuEEN platform, Monte Rosa has identified selective MGDs for CDK2, a highly validated oncogenic driver of breast, gynecological and other cancers
•Announced license and research collaboration agreement with Dr. Nir London and the Yeda Research and Development Company Ltd., the commercial arm of the Weizmann Institute of Science. The goal of the collaboration is to leverage innovative covalent chemistry to further expand the target space for molecular glue degradation
•Strengthened executive leadership team with promotions of Jullian Jones, Ph.D., J.D., MBA, to Chief Business Officer and Phil Nickson, Ph.D., J.D., to General Counsel
•Presented at recent scientific and medical conferences, including:
•3rd Annual Protein Degradation and Targeting Undruggables Congress, March 8-9
•ESMO Targeted Anticancer Therapies Congress 2022, March 7-8
•2nd Annual Targeted Protein Degradation Europe, March 15-17
UPCOMING MILESTONES & DATA PRESENTATIONS
•Submission of Investigational New Drug (IND) application to the U.S. Food and Drug Administration (FDA) for MRT-2359 expected in mid-2022
•Initiation of at least one additional lead optimization program expected in 2022
•Share new preclinical data supporting MRT-2359 program in a poster presentation at the upcoming American Association for Cancer Research (AACR) (Free AACR Whitepaper) Annual Meeting, hosted April 8-13, 2022, in New Orleans; presentation details, as follows:
Title: Identification of MRT-2359 a potent, selective and orally bioavailable GSPT1-directed molecular glue degrader (MGD) for the treatment of cancers with Myc-induced translational addiction
Abstract: 3929
Presenter: Gerald Gavory, Ph.D.
Date and Time: April 13, 2022, 9:00 AM – 12:30 PM
UPCOMING INVESTOR EVENTS
Monte Rosa will be participating in the following upcoming investor conferences:
•Wells Fargo Biotech Forum, April 11-13
•Piper Sandler Boston Biotech Bus Tour, May 4-5
•UBS Global Healthcare Conference, May 23-25
•Jefferies Global Healthcare Conference, June 8-10
FOURTH QUARTER AND FULL YEAR 2021 FINANCIAL RESULTS
Research and Development (R&D) Expenses: R&D expenses were $18.1 million for the fourth quarter of 2021 and $57.2 million for the year ended December 31, 2021, compared to $9.9 million and $24.0 million, respectively for the same periods of 2020. These increases were due to the expansion of research and development activities, including the development of our QuEEN
ACTIVE/115879056.5
platform and discovery, lead optimization efforts of our GSPT1 program, and the advancement of development candidate MRT-2359, as well as increases in headcount and laboratory-related expenses due to our continued growth as a research and development organization. R&D expenses included non-cash stock-based compensation of $1.0 million for the fourth quarter of 2021 and $2.6 million for the year ended December 31, 2021, compared to $0.1 million and $0.2 million, respectively, for the same periods in 2020.
General and Administrative (G&A) Expenses: G&A expenses for the fourth quarter of 2021 were $5.3 million compared to $2.1 million for the fourth quarter of 2020, and $15.7 million for the year ended December 31, 2021, compared to $4.0 million for the year ended December 31, 2020. The increase in G&A expenses were a result of increased headcount and expenses in support of the company’s growth and operations as a public company and director and officer liability insurance. G&A expenses included non-cash stock-based compensation of $1.0 million for the fourth quarter of 2021 and $2.6 million for the year ended December 31, 2021, compared to $0.1 million and $0.2 million, respectively, for the same periods in 2020.
Net Loss: Net loss for the fourth quarter of 2021 was $23.4 million compared to $19.7 million for the fourth quarter of 2020, and $74.0 million for the year ended December 31, 2021, compared to $35.9 million for the year ended December 21, 2020.
Cash Position and Financial Guidance: Cash, cash equivalents and restricted cash as of December 31, 2021, were $351.4 million, compared to $42.9 million as of December 31, 2020. The company expects that its cash and cash equivalents, including the aggregate net proceeds from the initial public offering, will be sufficient to fund planned operations and capital expenditures into late 2024.