On August 10, 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 June 30, 2023 (Press release, Monte Rosa Therapeutics, AUG 10, 2023, View Source [SID1234634201]).
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"During the second quarter, we continued focusing on advancing our clinical and preclinical portfolios, marking significant milestones, including the nomination of MRT-6160 as the development candidate for our VAV1 program. MRT-6160 is a potent, highly selective and orally bioavailable VAV1-targeting MGD. By selectively degrading VAV1, a protein pivotal to T and B cell signaling, MRT-6160 is designed to help patients with a range of severe autoimmune conditions. We expect to file an IND application for MRT-6160 in the first half of 2024," said Markus Warmuth, M.D., CEO of Monte Rosa Therapeutics. "Moreover, the Phase 1/2 trial of MRT-2359, our GSPT1-directed MGD, in MYC-driven solid tumors is enrolling well and we anticipate sharing initial clinical data this year. Our strong cash reserve supports further development of our groundbreaking pipeline of investigational MGD-based medicines and the discovery of additional MGD development candidates through our innovative QuEEN discovery engine."
In addition, this morning, Monte Rosa announced the resignation of Ajim Tamboli, CFA, who has served as the Company’s Chief Financial Officer (CFO). "Ajim was an instrumental part of Monte Rosa’s path to and through its initial public offering (IPO) and of the Company’s leadership team. We thank him for his service to the Company and wish him all the best in his future endeavors," said Dr. Warmuth.
SECOND QUARTER 2023 AND RECENT HIGHLIGHTS
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Announced development candidate MRT-6160, a VAV1-directed MGD, for the treatment of autoimmune diseases
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Received Orphan Drug Designation from the U.S. Food and Drug Administration (FDA) for MRT-2359 for the treatment of small cell lung cancer (SCLC)
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Presented preclinical data highlighting the preferential activity of MRT-2359, an orally bioavailable GSPT1-directed MGD, in MYC-driven solid tumors at the 2023 American Association for Cancer Research (AACR) (Free AACR Whitepaper) Annual Meeting
UPCOMING MILESTONES
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On track to present initial Phase 1/2 clinical data for MRT-2359 in MYC-driven solid tumors, including pharmacokinetics (PK), pharmacodynamics (PD), safety, and available initial efficacy data, in the second half of 2023
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On track for planned IND submission for MRT-6160 in the first half of 2024
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On track to nominate development candidates for one or more additional preclinical programs in the second half of 2023
SECOND QUARTER 2023 FINANCIAL RESULTS
Research and Development (R&D) Expenses: R&D expenses for the second quarter of 2023 were $29.1 million, compared to $20.9 million for the second 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, 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 $2.3 million of R&D expenses for Q2 2023, compared to $1.4 million in the same period in 2022.
General and Administrative (G&A) Expenses: G&A expenses for the second quarter of 2023 were $8.1 million compared to $6.3 million for the second 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. G&A expenses included non-cash stock-based compensation of $1.9 million for the second quarter of 2023, compared to $1.4 million for the same period in 2022.
Net Loss: Net loss for the second quarter of 2023 was $35.2 million, compared to $26.5 million for the second quarter of 2022.
Cash Position and Financial Guidance: Cash, cash equivalents, restricted cash, and marketable securities as of June 30, 2023, were $207.6 million, compared to cash, cash equivalents, restricted cash, and marketable securities of $237.0 million as of March 31, 2023. The decrease of $29.4 million was primarily related to cash used to fund operations. The company expects its cash and cash equivalents will be sufficient to fund planned operations and capital expenditures into 2025.
About MRT-2359
MRT-2359 is a potent, selective and orally bioavailable investigational 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 this addiction to MYC-induced protein translation creates a dependency on GSPT1. By inducing degradation of GSPT1, MRT-2359 is designed to exploit this vulnerability, disrupting the protein synthesis machinery, leading to anti-tumor activity in MYC-driven tumors.
About MRT-6160
MRT-6160 is a potent, highly selective, and orally bioavailable investigational degrader of VAV1, which in our in vitro studies has shown deep degradation of its target with no detectable effects on other proteins. VAV1, a Rho-family guanine nucleotide exchange factor, is a key signaling protein downstream of both the T-and B-cell receptors. VAV1 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. This modulation is evident both in vitro and in vivo, demonstrated by a significant decrease in cytokine secretion, proteins vital for maintaining autoimmune diseases. Moreover, VAV1-directed MGDs have shown promising activity in preclinical models of autoimmune diseases and thus have the potential to provide therapeutic benefits in multiple autoimmune indications, such as multiple sclerosis, rheumatoid arthritis, and dermatological disorders. Preclinical studies demonstrate MRT-6160 inhibits disease progression in in vivo autoimmunity models.