On August 6, 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 second quarter ended June 30, 2026.

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"We’re tremendously proud of our progress to date in 2026, defined by strong execution across our clinical-stage portfolio, with two Phase 2 trials activated and additional trials expected across our programs," said Markus Warmuth, M.D., Chief Executive Officer of Monte Rosa Therapeutics. "Importantly, for our VAV1 program, Novartis recently activated a Phase 2 study evaluating MRT-6160 (DDY391) in individuals with Sjögren’s disease, representing an important step forward for this program and established collaboration. We look forward to additional Phase 2 study activations expected as part of a broader development effort to evaluate the potential of MRT-6160 across other immune-mediated diseases. In addition, the Phase 2 study of MRT-2359 in combination with apalutamide in mCRPC patients with AR mutations is now activated, and we expect to enroll our first patients imminently, positioning us to validate the strong signals of clinical activity we observed in this patient population in our Phase 1/2 trial. We will update data from the initial Phase 1/2 arm exploring MRT-2359 in advanced CRPC by the end of the year."

Dr. Warmuth continued: "Moving forward, we expect a catalyst-rich second half of 2026, including data from our GFORCE-1 study of MRT-8102 in subjects with elevated cardiovascular disease risk, the study having been fully enrolled in June. With these data, we look forward to deepening our understanding of MRT-8102’s clinical activity across multiple dose levels and its impact on inflammatory and cardiometabolic biomarker endpoints. In particular, we will present data on levels of damage-associated molecular patterns (DAMPs) such as calprotectin that promote local inflammation, atherosclerotic plaque instability, and rupture of plaques in individuals with ASCVD – processes not adequately addressed by IL-1/IL-6 antibodies as well as pathologic cytokines and C-reactive protein (CRP), a well-established pharmacodynamic marker. Over the next 9 to 12 months, we expect to initiate three MRT-8102 Phase 2 studies, including our Phase 2b study, GFORCE-2, later this year, which will inform the potential of MRT-8102 to modulate key parameters of metabolic and atherosclerotic risk, liver inflammation and anemia of inflammation through both primary and secondary study endpoints, as well as GEMINI-1, our study to explore the potential of MRT-8102 to prevent recurrent gout flares following management of acute flares. In summary, we continue to be impressed by the potential of MRT-8102 to address sterile inflammation in a variety of disorders with high unmet medical need, and we continue to explore multiple promising development opportunities in that space."

RECENT HIGHLIGHTS

MRT-8102, NEK7-directed MGD for inflammatory diseases driven by the NLRP3 inflammasome and IL-1

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Enrollment and dosing have been completed for all subjects participating in the GFORCE-1 Phase 1 study of MRT-8102 in individuals with elevated cardiovascular disease (CVD) risk (NCT07119125). The GFORCE-1 study explored multiple dose levels in a 4-week treatment regimen and 4 weeks of safety follow-up to accelerate dose selection and development in multiple indications, including in atherosclerotic cardiovascular disease (ASCVD), gout, and hidradenitis suppurativa, with an anticipated readout in H2 2026. Based on data reported in January, in subjects with elevated CVD risk, MRT-8102 demonstrated rapid and durable reductions in systemic inflammation, including an 85% median reduction of CRP levels after four weeks of treatment. Additional biomarker data, including impact on calprotectin, an independent risk factor for ASCVD, will be reported.
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Monte Rosa expects to initiate multiple Phase 2 studies of MRT-8102 in indications with high unmet need and strong biologic rationale for targeting the NLRP3/IL-1 pathway:
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A Phase 2b study (GFORCE-2) of MRT-8102 in patients with elevated atherosclerotic risk and cardiometabolic syndrome is expected to initiate in H2 2026 to evaluate the effect of MRT-8102 treatment for 12 weeks (plus open-label extension) on multiple primary and secondary endpoints including key parameters of CVD and metabolic risk, liver inflammation, and anemia of inflammation.
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A Phase 2 study (GEMINI-1) of MRT-8102 in patients with gout is expected to initiate in Q4 2026 or Q1 2027. The study will investigate prevention of flare recurrence post management of acute flares with MRT-8102.
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A Phase 2 study (GALAXY-1) of MRT-8102 in patients with moderate to severe hidradenitis suppurativa is expected to initiate in H1 2027.

MRT-6160, VAV1-directed MGD for immune-mediated conditions

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Monte Rosa’s collaborator Novartis has activated a Phase 2 clinical study for the VAV1-directed MGD MRT-6160 (DDY391) in people living with Sjögren’s disease. Monte Rosa expects to receive a milestone payment upon the first patient visit in the Phase 2 clinical study. More information about the study, "A Phase 2a/b Study to Assess the Efficacy, Safety and Tolerability of DDY391 in Participants With Sjögren’s Disease," can be found at ClinicalTrials.gov, study identifier NCT07737743.
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Monte Rosa expects additional Phase 2 study activations as part of a broader development effort to evaluate the potential of MRT-6160 (DDY391) across immune-mediated diseases; Monte Rosa is eligible for additional Phase 2 milestones in conjunction with these study initiations.
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Monte Rosa has a global exclusive development and commercialization license agreement with Novartis to advance VAV1-directed MGDs, including MRT-6160 (DDY391). Monte Rosa is eligible to receive up to $2.1 billion in development, regulatory, and sales milestones, beginning upon initiation of Phase 2 studies. Novartis is responsible for conducting and funding Phase 2 studies. Monte Rosa will co-fund any Phase 3 clinical development and will share 30% of any profits and losses associated with the manufacturing and commercialization of MRT-6160 in the U.S., and is also eligible for tiered royalties on ex-U.S. net sales.

MRT-2359, GSPT1-directed MGD for metastatic CRPC

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Monte Rosa has activated the MODeFIRe-1 Phase 2 study of MRT-2359. The study will include up to 25 patients to efficiently assess the efficacy of MRT-2359 in combination with the second-generation AR inhibitor apalutamide in mCRPC patients with AR mutations, with potential to expand the study into additional patient subsets. Monte Rosa has a clinical supply agreement with Johnson & Johnson to support the Phase 2 trial evaluating MRT-2359 in combination with apalutamide.
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More information about the study, "MODeFIRe-1 (Molecular Degrader for Inhibitor Resistance): A Phase 2, Open-Label, Multicenter Study of Oral MRT-2359 in Combination with Apalutamide in Patients with Castration-Resistant Prostate Cancer," can be found at ClinicalTrials.gov, study identifier: NCT07745361.
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Enrollment in the initial Phase 1/2 study expansion arm, in patients with advanced CRPC, has been completed. A total of 6 patients with AR mutation 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.

Cyclin E1 and CDK2-directed MGD programs for solid tumors

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Monte Rosa expects to submit an IND application for its cyclin E1 (CCNE1)-directed molecular glue degrader program in 2027.
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Monte Rosa continues to advance its CDK2-directed MGD program for the treatment of ER+ breast cancer toward clinical development.

ANTICIPATED UPCOMING MILESTONES AND DEVELOPMENT PRIORITIES

Immunology and inflammation programs

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Readout of MRT-8102 GFORCE-1 study in subjects with elevated CVD risk anticipated in H2 2026.
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Initiate multiple Phase 2 studies of MRT-8102, including in elevated atherosclerotic risk patients in H2 2026, in gout flare patients in Q4 2026/Q1 2027, and in hidradenitis suppurativa patients in H1 2027.
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Submit an IND application for a second-generation NEK7-directed MGD in H2 2026.
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Monte Rosa expects its collaborator, Novartis, to initiate multiple Phase 2 studies of the VAV1-directed MGD MRT-6160 (DDY391) in immune-mediated diseases in 2026.
Oncology programs

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Update on the initial Phase 1/2 expansion arm exploring MRT-2359 in combination with enzalutamide in advanced CRPC by the end of the year.
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Dose the first patient in the MODeFIRe-1 Phase 2 study of MRT-2359 in combination with apalutamide in mCRPC in Q3 2026.
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Submit an IND application for a cyclin E1-directed MGD in 2027.

SECOND QUARTER 2026 FINANCIAL RESULTS

Collaboration Revenue: Collaboration revenue for the second quarter of 2026 was $9.0 million, compared to $23.2 million for the second quarter of 2025. 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 second quarter of 2026 were $48.0 million, compared to $30.7 million for the second quarter of 2025. The increase was primarily driven by increased spending on the MRT-8102 program and on other development and discovery programs. R&D expenses included non-cash stock-based compensation of $3.3 million for the second quarter of 2026, compared to $2.9 million in the same period in 2025.

General and Administrative (G&A) Expenses: G&A expenses for the second quarter of 2026 were $10.1 million compared to $8.1 million for the second quarter of 2025. G&A expenses included non-cash stock-based compensation of $2.7 million for the second quarter of 2026, compared to $2.0 million in the same period in 2025.

Net Loss: Net loss for the second quarter of 2026 was $43.4 million, compared to $12.3 million for the second quarter of 2025.

Cash Position and Financial Guidance:

Cash, cash equivalents, restricted cash, and marketable securities as of June 30, 2026, were $626.0 million, compared to cash, cash equivalents, restricted cash, and marketable securities of $671.2 million as of March 31, 2026. The decrease of $45.2 million was primarily due to operational use of cash. Monte Rosa expects that its cash, cash equivalents, restricted cash, and marketable securities will support operations into 2029.

(Press release, Monte Rosa Therapeutics, AUG 6, 2026, View Source [SID1234669800])