On May 11, 2023 Monte Rosa Therapeutics, Inc. (Nasdaq: GLUE), a clinical-stage biotechnology company developing novel molecular glue degrader (MGD)-based medicines, reported business highlights and financial results for the quarter ended March 31, 2023 (Press release, Monte Rosa Therapeutics, MAY 11, 2023, View Source [SID1234631524]).

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"During the first quarter, we made significant progress with our Phase 1/2 clinical trial of MRT-2359 in MYC-driven solid tumors. This trial continues to attract top oncologists and academic centers, and patient enrollment is on track for us to have initial data to share in the second half of the year. We remain excited about the prospect of bringing a potential therapeutic option to a range of indications driven by MYC, one of the most frequently altered families of oncogenes," said Markus Warmuth, M.D., CEO of Monte Rosa. "Furthermore, we expect to declare a development candidate in our VAV1 program in the second quarter. This milestone will mark a significant advancement in our pipeline of MGD-based medicines in the field of immunology and inflammation. We believe the underlying biology and our preclinical data support the potential of our VAV1-directed MGD to provide clinical benefit in multiple autoimmune diseases. Our continued progress with our pipeline speaks to the power of our QuEEN discovery engine and our position as a leading molecular glue degrader company. Backed by a strong balance sheet and a sharp focus on developing impactful medicines, we look forward to continuing to further the development of our molecular glue therapeutics."

FIRST QUARTER 2023 AND RECENT HIGHLIGHTS

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Presented preclinical data highlighting the preferential activity of MRT-2359, an orally bioavailable GSPT1-directed MGD, in MYC-driven tumor cells at the American Association for Cancer Research (AACR) (Free AACR Whitepaper) Annual Meeting 2023 in Orlando, FL
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Appointed Jan Skvarka, Ph.D., MBA, an accomplished biopharmaceutical executive with extensive operational, strategic, and financial expertise to the Company’s Board of Directors

UPCOMING MILESTONES

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On track to announce initial clinical data, including pharmacokinetic (PK), pharmacodynamic (PD), safety, and available initial efficacy data from the Phase 1 part of the ongoing Phase 1/2 clinical trial evaluating MRT-2359 in MYC-driven tumors, including non-small cell lung cancer, small cell lung cancer, and other MYC-driven tumors, in the second half of 2023
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On track to advance multiple preclinical programs to development candidates in immunology, inflammation, and oncology, including declaring a VAV1 development candidate in the second quarter of 2023

FIRST QUARTER 2023 FINANCIAL RESULTS

Research and Development (R&D) Expenses: R&D expenses for the first quarter of 2023 were $26.8 million, compared to $17.9 million for the first quarter of 2022. These increases were driven by the successful achievement of key milestones in our R&D organization, including the advancement of MRT-2359 in the clinic, the progression of our preclinical pipeline in lead optimization, and the continued development of the Company’s QuEEN platform for discovery efforts. The increase in R&D expenses was driven by increased headcount and laboratory-related expenses to achieve these milestones. Non-cash stock-based compensation constituted $2.1 million of R&D expenses for Q1 2023, compared to $1.2 million in the same period in 2022.

General and Administrative (G&A) Expenses: G&A expenses for the first quarter of 2023 were $7.5 million compared to $6.4 million for the first quarter of 2022. The increase in G&A expenses was a result of increased headcount and expenses in support of the company’s growth and operations as a public company. G&A expenses included non-cash stock-based compensation of $1.8 million for the first quarter of 2023, compared to $1.1 million for the same period in 2022.

Net Loss: Net loss for the first quarter of 2023 was $32 million, compared to $23.9 million for the first quarter of 2022.

Cash Position and Financial Guidance: Cash, cash equivalents, restricted cash, and marketable securities as of March 31, 2023, were $237 million, compared to cash, cash equivalents, and restricted cash of $268.1 million as of December 31, 2022. The decrease of $31.1 million was primarily related to cash used to fund operations in the first quarter, including a seasonal reduction in accrued expenses. The company expects that its cash and cash equivalents will be sufficient to fund currently planned operations and capital expenditures into 2025.

About MRT-2359

MRT-2359 is a potent, selective and orally bioavailable molecular glue degrader (MGD) that induces the interaction between the E3 ubiquitin ligase component cereblon and the translation termination factor GSPT1, leading to the targeted degradation of GSPT1 protein. The MYC transcription factors (c‑MYC, L-MYC and N-MYC) are well-established drivers of human cancers that maintain high levels of protein translation, which is critical for uncontrolled cell proliferation and tumor growth. Preclinical studies have shown that this addiction to MYC-induced protein translation creates a dependency on GSPT1. By inducing degradation of GSPT1, MRT-2359 exploits this vulnerability, disrupting the protein synthesis machinery, leading to anti-tumor activity in MYC-driven tumors.

About VAV1

VAV1, a Rho-family guanine nucleotide exchange factor, is a key signaling protein downstream of both the T and B cell receptors, whose expression is restricted to blood and immune cells, including T and B cells. Preclinical studies have shown that targeted degradation of VAV1 protein via an MGD modulates both T- and B-cell receptor-mediated activity in vitro and in vivo, as displayed by a significant decrease in cytokine secretion, as well as activity in preclinical models of immune diseases. VAV1-directed MGDs have the potential to provide therapeutic benefits in multiple autoimmune indications, such as multiple sclerosis, rheumatoid arthritis, and dermatological disorders.