(Mark One) ☒ QUARTERLY REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the quarterly period ended September 30, 2025 UNITED STATES SECURITIES AND EXCHANGE COMMISSION WASHINGTON, DC 20549 FORM 10-Q OR ☐ TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the transition period from ____________ to ____________ Commission File Number: 001-40522 Monte Rosa Therapeutics, Inc. (Exact name of registrant as specified in its charter) Delaware ...

Exhibit 99.1 Phase 1/2 study of GSPT1-directed MGD MRT-2359 advancing in heavily pretreated, metastatic castration-resistant prostate cancer (mCRPC) patients; additional results expected by year-end Strong cash position expected to fund operations through 2028, enabling multiple anticipated proof-of- concept clinical readouts across the portfolio BOSTON, Mass., Nov. 6, 2025 – Monte Rosa Therapeutics, Inc. (Nasdaq: GLUE), a clinical-stage biotechnology company developing novel molecular glue degrader (MGD)-b ...

Second agreement signed with Novartis to develop novel degraders for immune-mediated diseases, providing upfront payment of $120 million plus option maintenance payments, and eligibility for option exercise payments, milestones, and tiered royalties Phase 1 study of NEK7-directed MGD MRT-8102 underway, investigating a potential novel approach to treat inflammatory diseases driven by the NLRP3 inflammasome; initial readout including data from high-CVD risk cohort on track for H1 2026 VAV1-directed MGD MRT-61 ...

Core Insights - Monte Rosa Therapeutics is presenting preclinical data on MRT-6160, a molecular glue degrader targeting VAV1, at ACR Convergence 2025, indicating its potential to treat various autoimmune and inflammatory diseases [2][3] - MRT-6160 has shown significant efficacy in a preclinical autoimmune disease model, reducing multiple disease markers and demonstrating broad activity against chronic inflammation and organ involvement [3][6] Group 1: MRT-6160 Overview - MRT-6160 is a highly selective and orally bioavailable investigational drug that degrades VAV1, a key protein in immune signaling [5] - In preclinical studies, MRT-6160 demonstrated deep degradation of VAV1 with no detectable effects on other proteins, indicating its specificity [5] - The drug has shown promising results in models of autoimmune conditions, with a Phase 1 study confirming sustained, dose-dependent VAV1 degradation in T and B cells [5] Group 2: Clinical Development and Collaboration - Monte Rosa is collaborating with Novartis, which holds exclusive worldwide rights to develop and commercialize MRT-6160, with potential milestone payments up to $2.1 billion [5] - The company is co-funding Phase 3 clinical development and will share profits and losses from MRT-6160's commercialization in the U.S. [5] Group 3: Efficacy and Mechanism - In a spontaneous autoimmune disease model, MRT-6160 administration led to reduced proteinuria, lymphadenopathy, skin lesions, autoantibody production, and organomegaly [6] - The drug was found to be equivalent or superior to existing treatments like prednisone and anti-CD40L monoclonal antibodies across various disease metrics [6] - MRT-6160 effectively attenuated T and B cell effector functions, indicating its potential to block multiple pathogenic cytokines and autoantibodies [3][6]

Group 1 - Monte Rosa Therapeutics, Inc. (NASDAQ:GLUE) is recognized as a promising investment opportunity, with Pallas Capital Advisors acquiring 13,182 shares valued at approximately $59,000 during the second quarter [1] - The company has entered into a significant partnership with Novartis to develop molecular glue degraders for immune-mediated disorders, which is expected to generate $120 million in proceeds and has the potential for $5.7 billion in milestone payments [2] - Monte Rosa Therapeutics has received IND clearance from the FDA for MRT-8102, a second molecular glue degrader, indicating strong potential for future growth if initiatives are executed successfully [3] Group 2 - Monte Rosa Therapeutics is a clinical-stage biotechnology company based in Massachusetts, focused on developing novel small-molecule precision medicines, and has a strategic partnership with F. Hoffmann-La Roche Ltd [4]

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Core Insights - Monte Rosa Therapeutics (GLUE) shares surged 44% following a collaboration agreement with Novartis (NVS) to develop novel molecular glue degraders (MGD) for immune-mediated diseases [1][6]. Group 1: Collaboration Details - The collaboration involves Novartis obtaining an exclusive license to a discovery target developed through Monte Rosa's QuEEN platform, which utilizes artificial intelligence and machine learning [2]. - Novartis will also have options to license two additional programs from Monte Rosa's preclinical immunology portfolio, although publicly disclosed pipeline programs are excluded from this deal [3]. - Monte Rosa will receive an upfront payment of $120 million, with the total deal potentially valued at up to $5.7 billion, including milestone payments and royalties on future sales [4][7]. Group 2: Financial Impact - The deal significantly enhances Monte Rosa's cash position, which stood at $295.5 million as of June 2025, expected to fund operations into 2028 [6]. - The collaboration is seen as a validation of Monte Rosa's QuEEN platform and its MGD pipeline, which has underperformed compared to the industry this year [6]. Group 3: Pipeline Developments - Monte Rosa is advancing two additional pipeline candidates: MRT-8102 for inflammatory diseases and MRT-2359 for solid tumors, both in early-stage studies [9]. - Initial data from the phase I study of MRT-8102 is anticipated in the first half of 2026, while updates on MRT-2359 are expected by the end of this year [10]. Group 4: Other Collaborations - In addition to Novartis, Roche has also engaged with Monte Rosa, signing a strategic collaboration deal in October 2023 to develop MGDs for cancer and neurological diseases, valued at over $2 billion [11].

Company Overview - Monte Rosa Therapeutics (GLUE) shares increased by 44.1% to close at $6.93, with trading volume significantly higher than usual [1] - The stock has gained 5% over the past four weeks [1] Collaboration Deal - Monte Rosa entered a multi-billion-dollar collaboration with Novartis to develop therapies for immune-mediated diseases [2] - Novartis will receive an exclusive license to a discovery target developed using Monte Rosa's proprietary platform and options to license two programs from GLUE's preclinical immunology portfolio [2] Financial Terms of the Deal - Monte Rosa will receive an upfront payment of $120 million, along with option maintenance payments [3] - The total potential value of the deal is up to $5.7 billion, including royalties on future sales of the drug [3] Earnings Expectations - Monte Rosa is expected to report a quarterly loss of $0.28 per share, reflecting a year-over-year change of +3.5% [4] - Revenue is projected to be $14.07 million, up 52.6% from the same quarter last year [4] Stock Performance Insights - The consensus EPS estimate for Monte Rosa has remained unchanged over the last 30 days, indicating that stock price movements may not continue without earnings estimate revisions [5] - Monte Rosa currently holds a Zacks Rank of 3 (Hold) [5]

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