On November 10, 2022 Monte Rosa Therapeutics, Inc. (NASDAQ: GLUE), a biotechnology company developing novel molecular glue degrader (MGD)-based medicines, reported business highlights and financial results for the third quarter, ended September 30, 2022 (Press release, Monte Rosa Therapeutics, NOV 10, 2022, View Source [SID1234623832]).
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"Throughout 2022, we have made important strides in advancing our QuEENTM platform and our portfolio of MGDs derived from it, including our GSPT1 degrader MRT-2359. The FDA’s clearance of our first investigational new drug application, along with the recent initiation of patient dosing of MRT-2359 in our clinical trial in MYC-driven tumors, serve as strong validation of our platform, the quality of our team and the level of innovation we are bringing to the field," said Markus Warmuth, M.D., CEO of Monte Rosa. "We are continually progressing toward our goal of discovering and developing MGDs into a new generation of precision medicines for patients who currently have no real alternatives. With a strong cash position and investor support, we are well positioned to continue to execute on our first clinical program, as well as advance additional discovery programs through lead optimization."
THIRD QUARTER 2022 & RECENT HIGHLIGHTS
Received a Study May Proceed Letter from the U.S. Food and Drug Administration (FDA) to begin a Phase 1/2 clinical trial for MRT‑2359, a potent, selective and orally bioavailable GSPT1-directed MGD
Recently initiated patient dosing with MRT-2359, evaluating the treatment of MYC-driven solid tumors, including lung cancer
Advanced VAV1 degrader program into lead optimization; VAV1 plays a key role in T-cell and B-cell development and activation and is a highly validated target for multiple autoimmune diseases, as well as several types of lymphoma
Continued progress of CDK2 and NEK7 programs toward development candidate nominations
Entered into collaboration with Professor Sereina Riniker, Ph.D., (ETH Zürich) to integrate molecular dynamics into Monte Rosa’s AI/ML engine for target identification and virtual screening
Gave multiple presentations at the 5th Annual Targeted Protein Degradation Summit in October in Boston, which included new and updated preclinical data supporting development of MRT-2359 in MYC-driven lung cancer, and novel AI applications for the discovery of MGDs
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Presented overview of development of MRT-2359 as a GSPT1-directed MGD to target MYC-driven malignancies at the 34th EORTC-NCI-AACR (Free EORTC-NCI-AACR Whitepaper) Symposium on Oct. 28 in Barcelona, Spain
UPCOMING INVESTOR EVENTS
Monte Rosa will be participating in the following upcoming investor conferences:
Jefferies 13th Annual Global Healthcare Conference, Nov. 15-17, London
Piper Sandler 34th Annual Healthcare Conference, Nov. 29-Dec. 1, New York
41st Annual J.P. Morgan Health Care Conference, Jan. 9-12, 2023, San Francisco
THIRD QUARTER 2022 FINANCIAL RESULTS
Research and Development (R&D) Expenses: R&D expenses for the third quarter of 2022 were $21.3 million, compared to $15.1 million for the third quarter of 2021. These increases were due to the expansion of R&D activities, including the advancement of MRT-2359 toward clinical development and the development of the company’s QuEEN platform and its preclinical programs, as well as increased headcount and laboratory-related expenses due to the company’s continued growth as an R&D organization. R&D expenses for the third quarter of 2022 included non-cash stock-based compensation of $1.7 million and non-cash lease expense of $1.5 million due to a rent holiday on the company’s Harrison Avenue facility lease. The same period in 2021 included non-cash stock-based compensation expense of $1.1 million.
General and Administrative (G&A) Expenses: G&A expenses for the third quarter of 2022 were $7.0 million, compared to $4.8 million for the third quarter of 2021. The increase in G&A expenses was a result of additional expenses incurred in support of the company’s growth and operations as a public company. G&A expenses included non-cash stock-based compensation of $1.5 million for the third quarter of 2022, compared to $1.0 million for the same period in 2021.
Net Loss: Net loss for the third quarter of 2022 was $27.3 million, compared to $19.8 million for the third quarter of 2021.
Cash Position and Financial Guidance: Cash, cash equivalents, restricted cash and marketable securities as of September 30, 2022, were $277.4 million, compared to cash, cash equivalents and restricted cash of $299.5 million as of June 30, 2022. The decrease is primarily related to cash used to fund operations of $20.6 million and cash used for fixed assets of $1.4 million, partially off-set by proceeds from the exercise of stock options of $0.1 million. The company expects that its cash and cash equivalents will be sufficient to fund planned operations and capital expenditures into late 2024.