On August 12, 2021 Monte Rosa Therapeutics, Inc. (NASDAQ: GLUE), a biotechnology company developing novel molecular glue precision medicines, reported business highlights and financial results for the second quarter, ended June 30, 2021 (Press release, Monte Rosa Therapeutics, AUG 12, 2021, View Source [SID1234586516]).
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"Following our successful initial public offering and with several pivotal additions to our leadership team, we are excited to have the resources in place to advance our pipeline of novel molecular glues towards and into the clinic and to continue the development of our unique and proprietary QuEEN platform. We are delighted by the continuing progress of our pipeline of molecular glue degraders, including the recent transition of our NEK7 program into lead optimization," said Markus Warmuth, M.D., CEO of Monte Rosa. "As we look ahead for the year, we remain on track to progress a development candidate for our lead program targeting GSPT1 into IND-enabling studies. We also expect to advance at least one additional program into lead optimization this year. All of this will bring us closer to our goal of tackling the previously undruggable or inadequately drugged target protein universe and fostering a new generation of precision medicine therapeutics."
SECOND QUARTER 2021 & RECENT HIGHLIGHTS
Completed upsized $255.6 million initial public offering: Monte Rosa Therapeutics closed its initial public offering of 13,455,000 shares of common stock, including the exercise in full by the underwriters of their option to purchase up to 1,755,000 additional shares of common stock at the public offering price of $19.00 per share. The aggregate gross proceeds were approximately $255.6 million before deducting underwriting discounts and commissions and other offering expenses.
Advanced NEK7 program into lead optimization: NEK7 is an activator of the NLRP3 inflammasome, a central regulator of cellular inflammatory responses to pathogens, damage and stress. Aberrant NLRP3 inflammasome activation is implicated in the pathogenesis of multiple autoimmune diseases. Our NEK7 degrader program has progressed into lead optimization, with the next major milestone anticipated to be selection of a development candidate.
Strengthened leadership team with key appointments: Since the start of 2021, Monte Rosa Therapeutics has made several key appointments aimed at further supporting advancement of its platform, expanding its business operations and preparing to bring its molecular glue degrader therapies into clinical trials. Most recently, the company announced the appointment of Filip Janku, M.D., Ph.D., as Chief Medical Officer, and has named Phil Nickson, Ph.D., J.D., as Head of Legal Operations and Jennifer Champoux as Vice President of Operations.
Expanded global presence: The company has opened two new state-of-the-art research centers in the Seaport District of Boston and in Basel, Switzerland. These sites will continue to enable the recruitment of key talent in both the U.S. and Europe.
KEY UPCOMING MILESTONES + EVENTS
Development candidate selection for lead program targeting GSPT1 for the treatment of cancers overexpressing one of the Myc family genes (c-Myc, N-Myc and L-Myc). The company anticipates selecting a development candidate and advancing it into IND-enabling studies before year-end.
Progression of at least one program in addition to NEK7 into lead optimization by end of 2021.
Upcoming conferences and presentations:
Owen Wallace, Ph.D., Chief Scientific Officer, to present at the European Protein Degradation Conference at 14:10 CEST, Sept. 21, in a session titled, "Facilitating interactions between ubiquitin ligase and selected proteins through rational design of molecular glues."
Sharon Townson, Ph.D., Chief Technology Officer, to present an overview of the company’s QuEEN platform at the 4th Annual Targeted Protein Degradation Summit at 11:45 a.m. EDT, Oct. 27; will also participate in a panel discussion titled, "What’s Next on the Horizon for Targeted Protein Degradation?" at 5 p.m. EDT, Oct. 28.
John Castle, Chief Data Scientist, to present an overview of the company’s QuEEN platform at the Genomics Live and BioData World Congress at 15:40 CEST, Nov. 3.
SECOND QUARTER 2021 FINANCIAL RESULTS
Research and Development (R&D) Expenses: R&D expenses for the second quarter of 2021 were $14.6 million, compared to $4.9 million for the second quarter of 2020. The increase in R&D expense was primarily due to the expansion of research and development activities in the United States and Switzerland including increased headcount and facilities, as well as corresponding increases in laboratory related expenses.
General and Administrative (G&A) Expenses: G&A expenses for the second quarter of 2021 were $3.5 million, compared to $0.5 million for the second quarter of 2020. The increase in G&A expense was a result of increased headcount and expenses in support of the company’s growth.
Net Loss: Net loss for the second quarter of 2021 was $18.4 million, compared to $5.4 million for the second quarter of 2020.
Cash Position and Financial Guidance: Cash and cash equivalents as of June 30, 2021, were $357.1 million, compared to $41.7 million as of December 31, 2020. The June 30th balance does not include the additional $31.0 million in net proceeds the company received as part of its initial public offering from the full exercise of the underwriters’ option to purchase up to an additional 1,755,000 shares of common stock at the public offering price of $19.00 per share. The company expects its cash and cash equivalents , including the aggregate net proceeds from the initial public offering, will be sufficient to fund our planned operations and capital expenditures into late 2024.