On November 5, 2026 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 third quarter ended September 30, 2026.
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"The last quarter marks a tremendously important step forward for our clinical portfolio, with a positive readout from the GFORCE-1 study of MRT-8102, the initiation of Phase 2 development for MRT-2359, and the advancement of our partnered VAV1 program into two Phase 2 studies," said Markus Warmuth, M.D., Chief Executive Officer of Monte Rosa Therapeutics. "The GFORCE-1 results reinforce our view that targeting NEK7 at the top of the NLRP3 signaling cascade could address a broader set of disease drivers than targeting individual downstream cytokines. Our planned Phase 2 studies in coronary artery disease (CAD), gout, and hidradenitis suppurativa, conditions with major unmet needs, are intended to deepen our understanding of the therapeutic potential of NEK7 degradation. In CAD, our innovative study design integrates molecular and imaging-based readouts to explore how MRT-8102’s broad biological activity translates into changes in coronary plaque biology, to inform patient selection and design for an efficient future Phase 3 study."
Dr. Warmuth continued: "We are particularly excited about the opportunity in gout, where there is a substantial unmet need for effective flare prevention that is well tolerated with prolonged use. With the emergence of next-generation urate-lowering drugs and their propensity to induce flares in the first 6 to 12 months of use, we believe the need for a well-tolerated, non-immunosuppressive flare prevention treatment will only increase. We expect initial data from our Phase 2 gout study in H2 2027. Across the broader pipeline, we are pursuing a focused development strategy for MRT-2359 through MODeFIRe-1, evaluating its potential in combination with apalutamide in mCRPC patients with AR mutations. We have shown previously that degradation of GSPT1 dampens MYC signaling in CRPC, a pathway we believe is moving to center stage for new treatment options in CRPC. We look forward to a data update from this Phase 2 study in 2027, as well as a final data update from our completed Phase 1/2 study of MRT-2359 in combination with enzalutamide by year-end. Novartis’s advancement of MRT-6160 (DDY391) into Phase 2 studies in Sjögren’s disease and psoriatic arthritis expands the evaluation of VAV1 degradation across immune-mediated diseases and brings additional non-dilutive funding to Monte Rosa. With our balance sheet expected to support operations into 2029, we are well positioned to pursue these opportunities while maintaining a disciplined focus on generating clinical evidence and advancing our pipeline."
RECENT HIGHLIGHTS
MRT-8102, NEK7-directed MGD for inflammatory diseases driven by NEK7/NLRP3 and IL-1
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In October, Monte Rosa reported positive results from GFORCE-1 (NCT07119125), a Phase 1 study of MRT-8102 in 108 obese subjects with elevated cardiovascular disease risk. Across all three dose levels, MRT-8102 achieved median NEK7 degradation of approximately 80% to 90%. MRT-8102 also resulted in substantial reductions of IL-1β as well as HMGB1, calprotectin, S100A12, and SAA, damage-associated molecular patterns (DAMPs) linked to pathogenic biology within atherosclerotic plaques and vessel walls. MRT-8102 was well tolerated, with no serious adverse events, adverse event rates similar to placebo, and no evidence of increased infection risk.
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With dose selection informed by the GFORCE-1 data, Monte Rosa plans to initiate three Phase 2 studies of MRT-8102:
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GEMINI-1, a Phase 2 study in patients with gout, is expected to initiate in Q4 2026. The study will evaluate prevention of flare recurrence following management of acute flares, with initial data expected in H2 2027.
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GFORCE-2, a focused Phase 2b study in patients with stable coronary artery disease and residual inflammation, is expected to initiate in H1 2027. The study is expected to evaluate imaging-based coronary artery plaque assessment, such as fat attenuation index (FAI), along with NLRP3 genetics and molecular drivers of local disease pathogenesis and systemic inflammation, to inform the design of an innovative and efficient Phase 3 study focused on the most disease-modifiable patient population.
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GALAXY-1, a Phase 2 study in patients with moderate to severe hidradenitis suppurativa, is expected to initiate in H1 2027.
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Due to prioritization of the MRT-8102 Phase 2 study initiations, Investigational New Drug (IND) submission for the next-generation NEK7 MGD is now anticipated in 2027.
MRT-2359, GSPT1-directed MGD for mCRPC
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In August, Monte Rosa dosed the first patient in MODeFIRe-1 (NCT07745361), a Phase 2 study of MRT-2359 in combination with apalutamide in AR-mutant mCRPC patients who received prior treatment with a second-generation AR inhibitor. The study will enroll up to 25 patients, with MRT-2359 administered orally at 0.5 mg on a 21 days on, 7 days off schedule. Endpoints include PSA response, RECIST response, duration of response, radiographic progression-free survival, PSA progression-free survival, and safety. Monte Rosa has a clinical supply agreement with Johnson & Johnson to support the study.
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Enrollment in the initial Phase 1/2 study expansion arm, in patients with mCRPC, has been completed. A total of 6 patients with AR mutations were enrolled and treated with MRT-2359 in combination with enzalutamide. Monte Rosa plans to provide an update on this patient subset by the end of the year. Interim data were presented at the ASCO (Free ASCO Whitepaper) Genitourinary Cancers Symposium (ASCO GU) in February.
MRT-6160 (DDY391), VAV1-directed MGD for immune-mediated conditions
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In September, Monte Rosa announced achievement of a milestone associated with its collaborator Novartis initiating a global Phase 2a/b randomized, double-blind, placebo-controlled study (NCT07737743), evaluating the efficacy, safety, and tolerability of up to 52 weeks of treatment with MRT-6160 (DDY391) in participants with Sjögren’s disease. The first patient visit triggered a $50 million milestone payment to Monte Rosa.
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In October, Monte Rosa announced achievement of an additional milestone associated with Novartis initiating a second Phase 2 study of MRT-6160 (DDY391) in participants with active moderate to severe psoriatic arthritis (PsA). The Phase 2a/b randomized, double-blind, placebo-controlled, multicenter study (NCT07801495) will evaluate the efficacy, safety, tolerability, and dose-response relationship of MRT-6160 (DDY391). The first patient visit triggered a $37.5 million milestone payment to Monte Rosa.
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The Sjögren’s and PsA studies are the first two of several studies expected for MRT-6160 (DDY391). Under its global exclusive development and commercialization license agreement with Novartis, Monte Rosa is eligible for additional Phase 2 study initiation milestone payments.
CDK2 and Cyclin E1-directed MGD programs for solid tumors
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Monte Rosa expects to submit IND applications for its CDK2 and cyclin E1 (CCNE1)-directed MGD programs in 2027.
ANTICIPATED UPCOMING MILESTONES AND DEVELOPMENT PRIORITIES
Immunology and inflammation programs
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Initiate GEMINI-1 Phase 2 study of MRT-8102 in gout in Q4 2026, with initial data expected in H2 2027.
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Initiate GFORCE-2 Phase 2b study of MRT-8102 in stable coronary artery disease in H1 2027.
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Initiate GALAXY-1 Phase 2 study of MRT-8102 in moderate to severe hidradenitis suppurativa in H1 2027.
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Monte Rosa expects its collaborator, Novartis, to initiate additional Phase 2 studies of MRT-6160 (DDY391) in immune-mediated diseases.
Oncology programs
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Provide a clinical data update on the initial Phase 1/2 expansion arm exploring MRT-2359 in combination with enzalutamide in mCRPC by the end of 2026.
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Provide a clinical data update on the MODeFIRe-1 Phase 2 study of MRT-2359 in combination with apalutamide in mCRPC patients with AR mutations in 2027.
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Submit an IND application for a CDK2-directed MGD in 2027.
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Submit an IND application for a CCNE1-directed MGD in 2027.
THIRD QUARTER 2026 FINANCIAL RESULTS
Collaboration Revenue: Collaboration revenue for the third quarter of 2026 was $54.4 million, compared to $12.8 million for the third quarter of 2025. The increase was primarily driven by recognition of collaboration revenue from the $50.0 million milestone triggered by the initiation of the Novartis Phase 2 study of MRT-6160 (DDY391) in participants with Sjögren’s disease. The $37.5 million milestone triggered by the initiation of the Novartis Phase 2 study of MRT-6160 (DDY391) in participants with psoriatic arthritis in October is not reflected in third quarter collaboration revenue as it was triggered after the end of the quarter. Collaboration revenue represents amounts earned from Monte Rosa’s collaboration and license agreements with Roche and Novartis.
Research and Development (R&D) Expenses: R&D expenses for the third quarter of 2026 were $45.4 million, compared to $36.7 million for the third quarter of 2025. The increase was primarily driven by increased spending on development and discovery programs. R&D expenses included non-cash stock-based compensation of $3.3 million for the third quarter of 2026, compared to $2.5 million in the same period in 2025.
General and Administrative (G&A) Expenses: G&A expenses for the third quarter of 2026 were $10.9 million, compared to $9.1 million for the third quarter of 2025. G&A expenses included non-cash stock-based compensation of $3.0 million for the third quarter of 2026, compared to $1.9 million in the same period in 2025.
Net Income (Loss): Net income for the third quarter of 2026 was $3.1 million, compared to a net loss of $27.1 million for the third quarter of 2025.
Cash Position and Financial Guidance: Cash, cash equivalents, restricted cash, and marketable securities as of September 30, 2026, were $582.6 million, compared to $626.0 million as of June 30, 2026. The decrease of $43.4 million was primarily due to operational use of cash. In September, Monte Rosa announced achievement of a $50 million milestone associated with the first patient visit of the Novartis Phase 2 study of MRT-6160 (DDY391) in participants with Sjögren’s disease. In October, Monte Rosa announced achievement of a $37.5 million milestone associated with the first patient visit of the Novartis Phase 2 study of MRT-6160 (DDY391) in participants with active moderate to severe psoriatic arthritis. Cash receipts from these milestones are not reflected in the September 30th cash balance as the payments had not yet been received as of that date. Monte Rosa expects that its cash, cash equivalents, restricted cash, and marketable securities will support operations into 2029.
(Press release, Monte Rosa Therapeutics, NOV 5, 2026, View Source [SID1234674318])