{"success":true,"data":{"pressRelease":{"id":"157836","rtpr_id":"nGNX8DpyQl-20261001","ticker":"GLUE","exchange":"NASDAQ","all_tickers":["GLUE"],"title":"Monte Rosa Therapeutics Announces Positive Results for MRT-8102 in GFORCE-1 Phase 1 Study Showing Normalization of Key Pathogenic Drivers of ASCVD in Subjects with Elevated CVD Risk","author":"Globe Newswire","published_at":"2026-10-01T11:00:01.170Z","article_body":"In obese subjects at elevated cardiovascular disease (CVD) risk, MRT-8102, a\nNEK7-directed molecular glue degrader in development for the treatment of\nNLRP3/IL-1-driven inflammatory diseases, normalized multiple atherosclerotic\ncardiovascular disease (ASCVD) pathogenic drivers of local plaque\ninflammation, thrombosis, and systemic inflammation\n\nRobust and sustained NEK7 degradation observed across 5 mg, 20 mg, and 40 mg\nonce-daily dose levels, with similar biomarker reductions at all three doses\n\nHMGB1, calprotectin, S100A12, and SAA, damage-associated molecular patterns\n(DAMPs) linked to atherosclerotic plaque progression and instability, and\nIL-1β, all established key pathogenic drivers of ASCVD, were reduced to\nlevels comparable to normal physiological levels seen in the healthy volunteer\npopulation of Phase 1 study\n\nMRT-8102 was safe and well tolerated over four weeks of dosing and four weeks\nof follow-up, with no serious adverse events, treatment-emergent adverse event\nrates comparable to placebo, and no evidence of increased infection risk\n\nPhase 2 trials planned across coronary artery disease (GFORCE-2), gout\n(GEMINI-1), and moderate to severe hidradenitis suppurativa (GALAXY-1)\n\nCompany to host conference call and webcast today, Oct. 1, at 8:00 a.m. ET\n\nBOSTON, Oct. 01, 2026 (GLOBE NEWSWIRE) -- Monte Rosa Therapeutics, Inc.\n(Nasdaq: GLUE), a clinical-stage biotechnology company developing novel\nmolecular glue degrader (MGD)-based medicines, today announced positive data\nfrom GFORCE-1, a Phase 1 study evaluating MRT-8102, a NEK7-directed MGD being\ndeveloped for the treatment of inflammatory conditions driven by the\nNEK7/NLRP3 pathway.\n\n“The GFORCE-1 data are highly encouraging and show that MRT-8102 does\nprecisely what we designed it to do: potently and selectively degrade NEK7 and\nreduce levels of upstream and downstream drivers of residual plaque\ninflammation and thrombotic risk, and it does so with a differentiated and\nfavorable safety profile,” said Markus Warmuth, M.D., Chief Executive\nOfficer of Monte Rosa Therapeutics. “We are particularly excited about our\ntranslational approach, including our unique and broad analysis of the\nNEK7/NLRP3 upstream pathway, that has allowed us to gain unprecedented\ninsights into how inhibition of the pathway through NEK7 degradation leads to\nnormalization of many of the most important drivers of atherosclerotic plaque\nformation, progression, and rupture. To that end, we observed compelling\nreductions of HMGB1, calprotectin, S100A12, SAA, and IL-1β. These DAMPs and\ncytokines are linked to pathogenic biology within atherosclerotic plaques and\nvessel walls, and they have been identified as independent risk factors of\nmuch greater significance than some of the systemic inflammatory markers\nevaluated in other studies. We have also seen intriguing correlation of these\nmarkers with NLRP3 risk alleles, opening up opportunities for a precision\nmedicine approach. The GFORCE-1 study results, alongside a body of genetic,\nbiological, and clinical data, reinforce our rationale for degrading NEK7 to\nsimultaneously dampen multiple key ASCVD disease drivers that can lead to\natherosclerosis, plaque progression, and thrombogenesis. We believe targeting\nNEK7 at the top of the NLRP3 signaling cascade has the potential to provide a\ndegree of clinical impact across NEK7/NLRP3-driven diseases not achievable by\ntargeting individual downstream cytokines.”\n\nFilip Janku, M.D., Ph.D., Chief Medical Officer of Monte Rosa Therapeutics,\ncommented, “We believe our results represent the most comprehensive\ntranslational data set reported to date for the NEK7/NLRP3 pathway. GFORCE-1\nwas designed to provide a broad view of the pharmacodynamic activity and\nsafety of MRT-8102, and the profile we observed further bolsters our\nenthusiasm for continued development in cardiovascular disease and other\nindications. With dose selection now informed by these data, we plan to\ninitiate GFORCE-2, a focused Phase 2b study in patients with coronary artery\ndisease, in the first half of 2027. In GFORCE-2, our goal is to connect\nimaging-based coronary artery plaque assessment, such as fat attenuation index\n(FAI), with NLRP3 genetics and molecular drivers of local disease pathogenesis\nand systemic inflammation to inform the design of an innovative and efficient\nPhase 3 study focused on the most disease-modifiable patient population. We\nalso expect to initiate GEMINI-1, a Phase 2 study in gout, in Q4 2026 or Q1\n2027, and GALAXY-1, a Phase 2 study in moderate to severe hidradenitis\nsuppurativa, in the first half of 2027, representing additional substantial\nopportunities associated with this pathway.”\n\nGFORCE-1 (clinicaltrials.gov identifier NCT07119125) enrolled 108 obese\nsubjects with elevated CVD risk, randomized to MRT-8102 at once-daily doses of\n5 mg, 20 mg, or 40 mg, or to placebo. The GFORCE-1 study followed\nbest-in-class data from the single ascending dose (SAD) and multiple ascending\ndose (MAD) cohorts in healthy volunteers, and those data were previously\nreported\n(https://www.globenewswire.com/Tracker?data=-QextCrzdyyM3TKC_slAoF9M6becxEJGFFjAONVASJPnevIMpBdj-oRiXqdx3u2Z-Fau46O8j7a7ytvsX9HMAeXjGbjA3ZKRs82JNSmKThMgjRHVELmCh_bcE85RHnnH_smIzuwpxSRMgvOLVyrthlTM_6KVEh1TruLMITWl92ppDYrjhS4PxPdKLGmUkaeONlLBvfkOdbZUIvDgdmT4IcN479zJpm-p4OWFIY2mgOc=).\nThe GFORCE-1 study evaluated safety and tolerability, along with multiple\npharmacodynamic markers, over a four-week treatment regimen, followed by four\nweeks of safety follow-up. Multiple dose levels were explored to support dose\nselection for further development across various NLRP3-driven diseases,\nincluding ASCVD, gout, and hidradenitis suppurativa.\n\nSummary of GFORCE-1 Results\n* GFORCE-1 enrolled 108 obese subjects with elevated CVD risk, randomized to\nMRT-8102 at 5 mg, 20 mg, or 40 mg once daily, or to placebo, for 4 weeks of\ndosing and 4 weeks of follow-up safety evaluation.\n* MRT-8102 achieved robust and sustained NEK7 degradation, with a median\nreduction of approximately 80 to 90% observed across all three dose levels.\n* Both local drivers of plaque growth and progression and systemic\ninflammatory biomarkers were substantially reduced following MRT-8102\nadministration at all three dose levels to levels comparable with baseline\nvalues from Phase 1 healthy volunteers.\n* Median values of calprotectin, S100A12, and SAA, which are critical drivers\nof ASCVD progression, were lowered by 56%, 46%, and 51%, respectively.\n* Median values of HMGB1 and IL-1β were elevated at baseline and decreased\ntoward healthy volunteer levels following treatment among subjects with\nelevated levels. Median reductions were 40% and 37%, respectively, in subjects\nwith levels in the top quartile.\n* The thrombogenic factor fibrinogen was reduced by a median of 28% to levels\nconsistent with those in healthy volunteers.\n* IL-6 and hsCRP, biomarkers of systemic inflammation, were reduced by a\nmedian of 54% and 85%, respectively. All three doses of MRT-8102 resulted in\nrapid and sustained reductions in hsCRP to levels comparable to baseline in\nhealthy volunteers from the healthy volunteer cohorts.\n* MRT-8102 administration reduced median lipoprotein(a) by 24%, comparable to\nPCSK9 inhibitors. Unlike IL-6(R) blockade, MRT-8102 treatment did not increase\nLDL-C or triglyceride levels.\n* Significant increases in baseline biomarker levels were identified in\ncarriers of NLRP3 risk alleles (approximately 30% of the GFORCE-1 population),\nparticularly for DAMPs and IL-1β, suggesting a higher-risk, genetically\nenrichable population for potential future development.\n* MRT-8102 was well tolerated over four weeks of dosing and four weeks of\nfollow-up. No serious adverse events (SAEs) were reported. Rates of\ntreatment-emergent adverse events (TEAEs) were similar between MRT-8102 and\nplacebo, occurring in 33% of MRT-8102 participants and 30% of placebo\nparticipants, with no evidence of increased infection risk.\nPhase 2 Program for MRT-8102\n\nMonte Rosa expects to initiate multiple Phase 2 studies of MRT-8102 in\nindications with high unmet need and strong biologic rationale for targeting\nthe NEK7/NLRP3 pathway:\n* GFORCE-2, a focused Phase 2b study of MRT-8102 in patients with stable\ncoronary artery disease and residual inflammation, is expected to initiate in\nH1 2027. The study design, pending regulatory feedback, will evaluate changes\nin local pathogenic drivers of ASCVD, systemic biomarkers, and cardiovascular\nimaging over a six-month dosing period to specifically observe modulation of\nplaque biology, as well as changes in inflammatory, thrombogenic, and lipid\nmediators of disease. The Company is working to complete long-term preclinical\ntoxicology studies to support this 6-month study.\n* GEMINI-1, a Phase 2 study of MRT-8102 in patients with gout, is expected to\ninitiate in Q4 2026 or Q1 2027. The study will investigate prevention of flare\nrecurrence following management of acute flares with MRT-8102. Initial data\nare expected in H2 2027.\n* GALAXY-1, a Phase 2 study of MRT-8102 in patients with moderate to severe\nhidradenitis suppurativa, is expected to initiate in H1 2027.\nInvestor Conference Call\n\nMonte Rosa will host a conference call and webcast presentation today, October\n1, 2026, at 8:00 a.m. ET. A webcast of the presentation will be accessible via\nthe “Events & Presentations” section of Monte Rosa’s website at\nir.monterosatx.com. Registration for the conference call is available at the\nfollowing link\n(https://www.globenewswire.com/Tracker?data=SIop70ua6CXA6oq15AzJJh57mpWVH3YmrxmUO2SyqK3FLHP4aW14Q3vOix6l0fryzOswTOEC3QezibMoOToIDNR0utkk0G9tubw6UdP3Mgiy_yWsb3Kr1RITM5eq7Mxu08WRixCshymB4nGjkQHV9W4pS7YamFQfixAHIdDuGOc=).\nAn archived version of the webcast will be made available for 30 days\nfollowing the presentation.\n\nAbout MRT-8102\n\nMRT-8102 is a potent, highly selective, and orally bioavailable\ninvestigational molecular glue degrader (MGD) that targets NEK7 for the\ntreatment of inflammatory diseases linked to NLRP3 and IL-1 dysregulation.\nNEK7 has been shown to be required for NLRP3 inflammasome assembly,\nactivation, and IL-1β release both in vitro and in vivo. NLRP3 inflammasome\nactivation causes pyroptotic cell death, leading to the release of IL-1α/β,\nIL-18, and DAMPs such as HMGB1, calprotectin, S100A12, and SAA. IL-1β and\nIL-18 are highly inflammatory cytokines, and DAMPs further stimulate NLRP3\nactivity while promoting NLRP3-independent cytokine and chemokine production\nin neighboring cells. Together, DAMPs and IL-1 are responsible for the\nmajority of the local inflammation and tissue changes characteristic of ASCVD,\ngout, hidradenitis suppurativa, and other indications. The NEK7/NLRP3\ninflammasome plays a multifaceted role in plaque biology, contributing to\nplaque formation, plaque growth, vessel wall alterations, and thrombosis.\n\nAbout Monte Rosa\n\nMonte Rosa Therapeutics is a clinical-stage biotechnology company developing\nhighly selective molecular glue degrader (MGD) medicines for patients living\nwith serious diseases. MGDs are small molecule protein degraders that have the\npotential to treat many diseases that other modalities, including other\ndegraders, cannot. Monte Rosa’s QuEEN™ (Quantitative and Engineered\nElimination of Neosubstrates) discovery engine combines AI-guided chemistry,\ndiverse chemical libraries, structural biology, and proteomics to rationally\ndesign MGDs with unprecedented selectivity. Monte Rosa has developed the\nindustry’s leading pipeline of first-in-class and only-in-class MGDs,\nspanning autoimmune and inflammatory diseases, oncology, and beyond, with\nthree programs in the clinic. Monte Rosa has ongoing collaborations with\nleading pharmaceutical companies in the areas of immunology, oncology, and\nneurology. For more information, visit www.monterosatx.com.\n\nForward-Looking Statements\n\nThis communication includes express and implied “forward-looking\nstatements,” including forward-looking statements within the meaning of the\nPrivate Securities Litigation Reform Act of 1995. Forward-looking statements\ninclude all statements that are not historical facts and in some cases, can be\nidentified by terms such as “may,” “might,” “will,” “could,”\n“would,” “should,” “expect,” “intend,” “plan,”\n“objective,” “anticipate,” “believe,” “estimate,”\n“predict,” “potential,” “continue,” “ongoing,” or the negative\nof these terms, or other comparable terminology intended to identify\nstatements about the future. Forward-looking statements contained herein\ninclude, but are not limited to, statements about our ability to grow our\nproduct pipeline, our ability to successfully complete research and further\ndevelopment and commercialization of our drug candidates in current or future\nindications, including the timing and results of our clinical trials and our\nability to conduct and complete clinical trials, statements regarding our\nprogress and speed of development of only-in-class and first-in-class\nmolecular glue degrader therapeutics, statements around the Company's QuEEN™\ndiscovery engine and the broad potential applications of the platform and the\nCompany's ability to create long-term value through focused pipeline execution\nand strategic collaborations, statements about the advancement and timeline of\nour preclinical and clinical programs, pipeline and the various products\ntherein, statements regarding the positive Phase 1 data of MRT-8102 from the\nGFORCE-1 study, including the safety, tolerability, target engagement, and\nother results observed, statements regarding the potential of MRT-8102 to\nnormalize local and systemic pathologic drivers of ASCVD and to address\nNLRP3/IL-1-driven inflammatory diseases, our expectations regarding the\npotential of targeting NEK7 at the top of the NLRP3 inflammasome signaling\ncascade to provide differentiated clinical impact across NLRP3-driven\ndiseases, including compared with targeting individual downstream cytokines,\nstatements regarding the planned initiation of GFORCE-2, a Phase 2b study of\nMRT-8102 in patients with stable coronary artery disease and residual\ninflammation, including the expected timing, study design, regulatory feedback\nregarding the study design, use of coronary artery imaging, NLRP3 genetics and\nbiomarkers to identify a disease-modifiable patient population and inform the\ndesign of a potential Phase 3 study, and the completion of long-term\npreclinical toxicology studies to support GFORCE-2, statements regarding the\nplanned initiation of GEMINI-1, a Phase 2 study of MRT-8102 in patients with\ngout, including the expected timing, study design and objective of evaluating\nprevention of flare recurrence, and the expected timing of initial data,\nstatements regarding the planned initiation of GALAXY-1, a Phase 2 study of\nMRT-8102 in patients with moderate to severe hidradenitis suppurativa,\nincluding the expected timing, statements regarding dose selection informed by\nGFORCE-1 data for further development across various NLRP3-driven diseases,\nstatements regarding a genetically enrichable higher-risk population\nidentified through NLRP3 risk alleles for potential future development,\nstatements regarding opportunities for MRT-8102 in inflammatory diseases and\nstatements around our expectations of success for our programs, among others.\nBy their nature, these statements are subject to numerous risks and\nuncertainties, including those risks and uncertainties set forth in our most\nrecent Annual Report on Form 10-K for the year ended December 31, 2025, filed\nwith the U.S. Securities and Exchange Commission on March 17, 2026, and any\nsubsequent filings, that could cause actual results, performance or\nachievement to differ materially and adversely from those anticipated or\nimplied in the statements, as well as the risk that outcomes of preclinical\nstudies may not be predictive of clinical trial results and the risk that\ninitial or interim results from a clinical trial may not be predictive of the\nfinal results of the trial or the results of future trials. You should not\nrely upon forward-looking statements as predictions of future events. Although\nour management believes that the expectations reflected in our statements are\nreasonable, we cannot guarantee that the future results, performance, or\nevents and circumstances described in the forward-looking statements will be\nachieved or occur. Recipients are cautioned not to place undue reliance on\nthese forward-looking statements, which speak only as of the date such\nstatements are made and should not be construed as statements of fact. We\nundertake no obligation to publicly update any forward-looking statements,\nwhether as a result of new information, any future presentations, or\notherwise, except as required by applicable law. Certain information contained\nin these materials and any statements made orally during any presentation of\nthese materials that relate to the materials or are based on studies,\npublications, surveys and other data obtained from third-party sources and our\nown internal estimates and research. While we believe these third-party\nstudies, publications, surveys and other data to be reliable as of the date of\nthese materials, we have not independently verified, and make no\nrepresentations as to the adequacy, fairness, accuracy or completeness of, any\ninformation obtained from third-party sources. In addition, no independent\nsource has evaluated the reasonableness or accuracy of our internal estimates\nor research and no reliance should be made on any information or statements\nmade in these materials relating to or based on such internal estimates and\nresearch.\n\nInvestors\nAndrew Funderburk\nir@monterosatx.com\n\nMedia\nCory Tromblee, Scient PR\nmedia@monterosatx.com\n\n(https://www.globenewswire.com/NewsRoom/AttachmentNg/20ed9999-454a-4e2a-aabc-217270a87d2d)\n\n\n\nGlobeNewswire, Inc. 2026","article_body_html":"","raw_payload":{"data":{"id":"nGNX8DpyQl-20261001","title":"Monte Rosa Therapeutics Announces Positive Results for MRT-8102 in GFORCE-1 Phase 1 Study Showing Normalization of Key Pathogenic Drivers of ASCVD in Subjects with Elevated CVD Risk","author":"Globe Newswire","ticker":"GLUE","created":"2026-10-01T11:00:01.170Z","tickers":["GLUE"],"exchange":"NASDAQ","article_body":"In obese subjects at elevated cardiovascular disease (CVD) risk, MRT-8102, a\nNEK7-directed molecular glue degrader in development for the treatment of\nNLRP3/IL-1-driven inflammatory diseases, normalized multiple atherosclerotic\ncardiovascular disease (ASCVD) pathogenic drivers of local plaque\ninflammation, thrombosis, and systemic inflammation\n\nRobust and sustained NEK7 degradation observed across 5 mg, 20 mg, and 40 mg\nonce-daily dose levels, with similar biomarker reductions at all three doses\n\nHMGB1, calprotectin, S100A12, and SAA, damage-associated molecular patterns\n(DAMPs) linked to atherosclerotic plaque progression and instability, and\nIL-1β, all established key pathogenic drivers of ASCVD, were reduced to\nlevels comparable to normal physiological levels seen in the healthy volunteer\npopulation of Phase 1 study\n\nMRT-8102 was safe and well tolerated over four weeks of dosing and four weeks\nof follow-up, with no serious adverse events, treatment-emergent adverse event\nrates comparable to placebo, and no evidence of increased infection risk\n\nPhase 2 trials planned across coronary artery disease (GFORCE-2), gout\n(GEMINI-1), and moderate to severe hidradenitis suppurativa (GALAXY-1)\n\nCompany to host conference call and webcast today, Oct. 1, at 8:00 a.m. ET\n\nBOSTON, Oct. 01, 2026 (GLOBE NEWSWIRE) -- Monte Rosa Therapeutics, Inc.\n(Nasdaq: GLUE), a clinical-stage biotechnology company developing novel\nmolecular glue degrader (MGD)-based medicines, today announced positive data\nfrom GFORCE-1, a Phase 1 study evaluating MRT-8102, a NEK7-directed MGD being\ndeveloped for the treatment of inflammatory conditions driven by the\nNEK7/NLRP3 pathway.\n\n“The GFORCE-1 data are highly encouraging and show that MRT-8102 does\nprecisely what we designed it to do: potently and selectively degrade NEK7 and\nreduce levels of upstream and downstream drivers of residual plaque\ninflammation and thrombotic risk, and it does so with a differentiated and\nfavorable safety profile,” said Markus Warmuth, M.D., Chief Executive\nOfficer of Monte Rosa Therapeutics. “We are particularly excited about our\ntranslational approach, including our unique and broad analysis of the\nNEK7/NLRP3 upstream pathway, that has allowed us to gain unprecedented\ninsights into how inhibition of the pathway through NEK7 degradation leads to\nnormalization of many of the most important drivers of atherosclerotic plaque\nformation, progression, and rupture. To that end, we observed compelling\nreductions of HMGB1, calprotectin, S100A12, SAA, and IL-1β. These DAMPs and\ncytokines are linked to pathogenic biology within atherosclerotic plaques and\nvessel walls, and they have been identified as independent risk factors of\nmuch greater significance than some of the systemic inflammatory markers\nevaluated in other studies. We have also seen intriguing correlation of these\nmarkers with NLRP3 risk alleles, opening up opportunities for a precision\nmedicine approach. The GFORCE-1 study results, alongside a body of genetic,\nbiological, and clinical data, reinforce our rationale for degrading NEK7 to\nsimultaneously dampen multiple key ASCVD disease drivers that can lead to\natherosclerosis, plaque progression, and thrombogenesis. We believe targeting\nNEK7 at the top of the NLRP3 signaling cascade has the potential to provide a\ndegree of clinical impact across NEK7/NLRP3-driven diseases not achievable by\ntargeting individual downstream cytokines.”\n\nFilip Janku, M.D., Ph.D., Chief Medical Officer of Monte Rosa Therapeutics,\ncommented, “We believe our results represent the most comprehensive\ntranslational data set reported to date for the NEK7/NLRP3 pathway. GFORCE-1\nwas designed to provide a broad view of the pharmacodynamic activity and\nsafety of MRT-8102, and the profile we observed further bolsters our\nenthusiasm for continued development in cardiovascular disease and other\nindications. With dose selection now informed by these data, we plan to\ninitiate GFORCE-2, a focused Phase 2b study in patients with coronary artery\ndisease, in the first half of 2027. In GFORCE-2, our goal is to connect\nimaging-based coronary artery plaque assessment, such as fat attenuation index\n(FAI), with NLRP3 genetics and molecular drivers of local disease pathogenesis\nand systemic inflammation to inform the design of an innovative and efficient\nPhase 3 study focused on the most disease-modifiable patient population. We\nalso expect to initiate GEMINI-1, a Phase 2 study in gout, in Q4 2026 or Q1\n2027, and GALAXY-1, a Phase 2 study in moderate to severe hidradenitis\nsuppurativa, in the first half of 2027, representing additional substantial\nopportunities associated with this pathway.”\n\nGFORCE-1 (clinicaltrials.gov identifier NCT07119125) enrolled 108 obese\nsubjects with elevated CVD risk, randomized to MRT-8102 at once-daily doses of\n5 mg, 20 mg, or 40 mg, or to placebo. The GFORCE-1 study followed\nbest-in-class data from the single ascending dose (SAD) and multiple ascending\ndose (MAD) cohorts in healthy volunteers, and those data were previously\nreported\n(https://www.globenewswire.com/Tracker?data=-QextCrzdyyM3TKC_slAoF9M6becxEJGFFjAONVASJPnevIMpBdj-oRiXqdx3u2Z-Fau46O8j7a7ytvsX9HMAeXjGbjA3ZKRs82JNSmKThMgjRHVELmCh_bcE85RHnnH_smIzuwpxSRMgvOLVyrthlTM_6KVEh1TruLMITWl92ppDYrjhS4PxPdKLGmUkaeONlLBvfkOdbZUIvDgdmT4IcN479zJpm-p4OWFIY2mgOc=).\nThe GFORCE-1 study evaluated safety and tolerability, along with multiple\npharmacodynamic markers, over a four-week treatment regimen, followed by four\nweeks of safety follow-up. Multiple dose levels were explored to support dose\nselection for further development across various NLRP3-driven diseases,\nincluding ASCVD, gout, and hidradenitis suppurativa.\n\nSummary of GFORCE-1 Results\n* GFORCE-1 enrolled 108 obese subjects with elevated CVD risk, randomized to\nMRT-8102 at 5 mg, 20 mg, or 40 mg once daily, or to placebo, for 4 weeks of\ndosing and 4 weeks of follow-up safety evaluation.\n* MRT-8102 achieved robust and sustained NEK7 degradation, with a median\nreduction of approximately 80 to 90% observed across all three dose levels.\n* Both local drivers of plaque growth and progression and systemic\ninflammatory biomarkers were substantially reduced following MRT-8102\nadministration at all three dose levels to levels comparable with baseline\nvalues from Phase 1 healthy volunteers.\n* Median values of calprotectin, S100A12, and SAA, which are critical drivers\nof ASCVD progression, were lowered by 56%, 46%, and 51%, respectively.\n* Median values of HMGB1 and IL-1β were elevated at baseline and decreased\ntoward healthy volunteer levels following treatment among subjects with\nelevated levels. Median reductions were 40% and 37%, respectively, in subjects\nwith levels in the top quartile.\n* The thrombogenic factor fibrinogen was reduced by a median of 28% to levels\nconsistent with those in healthy volunteers.\n* IL-6 and hsCRP, biomarkers of systemic inflammation, were reduced by a\nmedian of 54% and 85%, respectively. All three doses of MRT-8102 resulted in\nrapid and sustained reductions in hsCRP to levels comparable to baseline in\nhealthy volunteers from the healthy volunteer cohorts.\n* MRT-8102 administration reduced median lipoprotein(a) by 24%, comparable to\nPCSK9 inhibitors. Unlike IL-6(R) blockade, MRT-8102 treatment did not increase\nLDL-C or triglyceride levels.\n* Significant increases in baseline biomarker levels were identified in\ncarriers of NLRP3 risk alleles (approximately 30% of the GFORCE-1 population),\nparticularly for DAMPs and IL-1β, suggesting a higher-risk, genetically\nenrichable population for potential future development.\n* MRT-8102 was well tolerated over four weeks of dosing and four weeks of\nfollow-up. No serious adverse events (SAEs) were reported. Rates of\ntreatment-emergent adverse events (TEAEs) were similar between MRT-8102 and\nplacebo, occurring in 33% of MRT-8102 participants and 30% of placebo\nparticipants, with no evidence of increased infection risk.\nPhase 2 Program for MRT-8102\n\nMonte Rosa expects to initiate multiple Phase 2 studies of MRT-8102 in\nindications with high unmet need and strong biologic rationale for targeting\nthe NEK7/NLRP3 pathway:\n* GFORCE-2, a focused Phase 2b study of MRT-8102 in patients with stable\ncoronary artery disease and residual inflammation, is expected to initiate in\nH1 2027. The study design, pending regulatory feedback, will evaluate changes\nin local pathogenic drivers of ASCVD, systemic biomarkers, and cardiovascular\nimaging over a six-month dosing period to specifically observe modulation of\nplaque biology, as well as changes in inflammatory, thrombogenic, and lipid\nmediators of disease. The Company is working to complete long-term preclinical\ntoxicology studies to support this 6-month study.\n* GEMINI-1, a Phase 2 study of MRT-8102 in patients with gout, is expected to\ninitiate in Q4 2026 or Q1 2027. The study will investigate prevention of flare\nrecurrence following management of acute flares with MRT-8102. Initial data\nare expected in H2 2027.\n* GALAXY-1, a Phase 2 study of MRT-8102 in patients with moderate to severe\nhidradenitis suppurativa, is expected to initiate in H1 2027.\nInvestor Conference Call\n\nMonte Rosa will host a conference call and webcast presentation today, October\n1, 2026, at 8:00 a.m. ET. A webcast of the presentation will be accessible via\nthe “Events & Presentations” section of Monte Rosa’s website at\nir.monterosatx.com. Registration for the conference call is available at the\nfollowing link\n(https://www.globenewswire.com/Tracker?data=SIop70ua6CXA6oq15AzJJh57mpWVH3YmrxmUO2SyqK3FLHP4aW14Q3vOix6l0fryzOswTOEC3QezibMoOToIDNR0utkk0G9tubw6UdP3Mgiy_yWsb3Kr1RITM5eq7Mxu08WRixCshymB4nGjkQHV9W4pS7YamFQfixAHIdDuGOc=).\nAn archived version of the webcast will be made available for 30 days\nfollowing the presentation.\n\nAbout MRT-8102\n\nMRT-8102 is a potent, highly selective, and orally bioavailable\ninvestigational molecular glue degrader (MGD) that targets NEK7 for the\ntreatment of inflammatory diseases linked to NLRP3 and IL-1 dysregulation.\nNEK7 has been shown to be required for NLRP3 inflammasome assembly,\nactivation, and IL-1β release both in vitro and in vivo. NLRP3 inflammasome\nactivation causes pyroptotic cell death, leading to the release of IL-1α/β,\nIL-18, and DAMPs such as HMGB1, calprotectin, S100A12, and SAA. IL-1β and\nIL-18 are highly inflammatory cytokines, and DAMPs further stimulate NLRP3\nactivity while promoting NLRP3-independent cytokine and chemokine production\nin neighboring cells. Together, DAMPs and IL-1 are responsible for the\nmajority of the local inflammation and tissue changes characteristic of ASCVD,\ngout, hidradenitis suppurativa, and other indications. The NEK7/NLRP3\ninflammasome plays a multifaceted role in plaque biology, contributing to\nplaque formation, plaque growth, vessel wall alterations, and thrombosis.\n\nAbout Monte Rosa\n\nMonte Rosa Therapeutics is a clinical-stage biotechnology company developing\nhighly selective molecular glue degrader (MGD) medicines for patients living\nwith serious diseases. MGDs are small molecule protein degraders that have the\npotential to treat many diseases that other modalities, including other\ndegraders, cannot. Monte Rosa’s QuEEN™ (Quantitative and Engineered\nElimination of Neosubstrates) discovery engine combines AI-guided chemistry,\ndiverse chemical libraries, structural biology, and proteomics to rationally\ndesign MGDs with unprecedented selectivity. Monte Rosa has developed the\nindustry’s leading pipeline of first-in-class and only-in-class MGDs,\nspanning autoimmune and inflammatory diseases, oncology, and beyond, with\nthree programs in the clinic. Monte Rosa has ongoing collaborations with\nleading pharmaceutical companies in the areas of immunology, oncology, and\nneurology. For more information, visit www.monterosatx.com.\n\nForward-Looking Statements\n\nThis communication includes express and implied “forward-looking\nstatements,” including forward-looking statements within the meaning of the\nPrivate Securities Litigation Reform Act of 1995. Forward-looking statements\ninclude all statements that are not historical facts and in some cases, can be\nidentified by terms such as “may,” “might,” “will,” “could,”\n“would,” “should,” “expect,” “intend,” “plan,”\n“objective,” “anticipate,” “believe,” “estimate,”\n“predict,” “potential,” “continue,” “ongoing,” or the negative\nof these terms, or other comparable terminology intended to identify\nstatements about the future. Forward-looking statements contained herein\ninclude, but are not limited to, statements about our ability to grow our\nproduct pipeline, our ability to successfully complete research and further\ndevelopment and commercialization of our drug candidates in current or future\nindications, including the timing and results of our clinical trials and our\nability to conduct and complete clinical trials, statements regarding our\nprogress and speed of development of only-in-class and first-in-class\nmolecular glue degrader therapeutics, statements around the Company's QuEEN™\ndiscovery engine and the broad potential applications of the platform and the\nCompany's ability to create long-term value through focused pipeline execution\nand strategic collaborations, statements about the advancement and timeline of\nour preclinical and clinical programs, pipeline and the various products\ntherein, statements regarding the positive Phase 1 data of MRT-8102 from the\nGFORCE-1 study, including the safety, tolerability, target engagement, and\nother results observed, statements regarding the potential of MRT-8102 to\nnormalize local and systemic pathologic drivers of ASCVD and to address\nNLRP3/IL-1-driven inflammatory diseases, our expectations regarding the\npotential of targeting NEK7 at the top of the NLRP3 inflammasome signaling\ncascade to provide differentiated clinical impact across NLRP3-driven\ndiseases, including compared with targeting individual downstream cytokines,\nstatements regarding the planned initiation of GFORCE-2, a Phase 2b study of\nMRT-8102 in patients with stable coronary artery disease and residual\ninflammation, including the expected timing, study design, regulatory feedback\nregarding the study design, use of coronary artery imaging, NLRP3 genetics and\nbiomarkers to identify a disease-modifiable patient population and inform the\ndesign of a potential Phase 3 study, and the completion of long-term\npreclinical toxicology studies to support GFORCE-2, statements regarding the\nplanned initiation of GEMINI-1, a Phase 2 study of MRT-8102 in patients with\ngout, including the expected timing, study design and objective of evaluating\nprevention of flare recurrence, and the expected timing of initial data,\nstatements regarding the planned initiation of GALAXY-1, a Phase 2 study of\nMRT-8102 in patients with moderate to severe hidradenitis suppurativa,\nincluding the expected timing, statements regarding dose selection informed by\nGFORCE-1 data for further development across various NLRP3-driven diseases,\nstatements regarding a genetically enrichable higher-risk population\nidentified through NLRP3 risk alleles for potential future development,\nstatements regarding opportunities for MRT-8102 in inflammatory diseases and\nstatements around our expectations of success for our programs, among others.\nBy their nature, these statements are subject to numerous risks and\nuncertainties, including those risks and uncertainties set forth in our most\nrecent Annual Report on Form 10-K for the year ended December 31, 2025, filed\nwith the U.S. Securities and Exchange Commission on March 17, 2026, and any\nsubsequent filings, that could cause actual results, performance or\nachievement to differ materially and adversely from those anticipated or\nimplied in the statements, as well as the risk that outcomes of preclinical\nstudies may not be predictive of clinical trial results and the risk that\ninitial or interim results from a clinical trial may not be predictive of the\nfinal results of the trial or the results of future trials. You should not\nrely upon forward-looking statements as predictions of future events. Although\nour management believes that the expectations reflected in our statements are\nreasonable, we cannot guarantee that the future results, performance, or\nevents and circumstances described in the forward-looking statements will be\nachieved or occur. Recipients are cautioned not to place undue reliance on\nthese forward-looking statements, which speak only as of the date such\nstatements are made and should not be construed as statements of fact. We\nundertake no obligation to publicly update any forward-looking statements,\nwhether as a result of new information, any future presentations, or\notherwise, except as required by applicable law. Certain information contained\nin these materials and any statements made orally during any presentation of\nthese materials that relate to the materials or are based on studies,\npublications, surveys and other data obtained from third-party sources and our\nown internal estimates and research. While we believe these third-party\nstudies, publications, surveys and other data to be reliable as of the date of\nthese materials, we have not independently verified, and make no\nrepresentations as to the adequacy, fairness, accuracy or completeness of, any\ninformation obtained from third-party sources. In addition, no independent\nsource has evaluated the reasonableness or accuracy of our internal estimates\nor research and no reliance should be made on any information or statements\nmade in these materials relating to or based on such internal estimates and\nresearch.\n\nInvestors\nAndrew Funderburk\nir@monterosatx.com\n\nMedia\nCory Tromblee, Scient PR\nmedia@monterosatx.com\n\n(https://www.globenewswire.com/NewsRoom/AttachmentNg/20ed9999-454a-4e2a-aabc-217270a87d2d)\n\n\n\nGlobeNewswire, Inc. 2026"},"type":"article","timestamp":"2026-10-01T11:00:01.600087558Z","server_sent_at_ms":1790852401600},"received_at":"2026-10-01T11:00:01.658Z","source_url":null},"analysis":{"id":"146489","press_release_id":"157836","analysis_json":{"industry":{"label":"Biotechnology","sector":"Health Care"},"redFlags":["Early Phase 1 biomarker data only; no clinical outcome evidence yet","GFORCE-2 initiation contingent on completion of long-term preclinical toxicology studies and regulatory feedback"],"eventType":"clinical_trial","narrative":"Monte Rosa Therapeutics reported positive Phase 1 GFORCE-1 results for MRT-8102, a NEK7-directed molecular glue degrader, in 108 obese subjects with elevated cardiovascular risk.\n\nNEK7 degradation was robust and sustained (~80-90% median) across all doses, with key ASCVD biomarkers (calprotectin -56%, SAA -51%, hsCRP -85%) normalized to healthy-volunteer levels and lipoprotein(a) reduced 24%, comparable to PCSK9 inhibitors.\n\nThe drug was well tolerated with no serious adverse events and TEAE rates similar to placebo (33% vs 30%).\n\nThree Phase 2 studies are planned: GFORCE-2 in coronary artery disease (H1 2027), GEMINI-1 in gout (Q4 2026/Q1 2027, initial data H2 2027), and GALAXY-1 in hidradenitis suppurativa (H1 2027).","sentiment":"bullish","agentHooks":{"shouldPost":true,"suggestedAngle":"Phase 1 wins for MRT-8102 de-risk the NEK7/NLRP3 pathway with three Phase 2 starts on deck -- watch GLUE into the GEMINI-1 gout readout."},"keyFigures":{"drugName":"MRT-8102","phaseOfTrial":"Phase 1","customDimensions":{"il6_reduction":"54%","lpa_reduction":"24%","saa_reduction":"51%","hscrp_reduction":"85%","s100a12_reduction":"46%","subjects_enrolled":108,"teae_rate_mrt8102":"33%","teae_rate_placebo":"30%","fibrinogen_reduction":"28%","calprotectin_reduction":"56%","nek7_degradation_median":"80-90%","il1b_reduction_top_quartile":"37%","hmgb1_reduction_top_quartile":"40%"}},"quotedText":"The GFORCE-1 data are highly encouraging and show that MRT-8102 does precisely what we designed it to do: potently and selectively degrade NEK7 and reduce levels of upstream and downstream drivers of residual plaque inflammation and thrombotic risk, and it does so with a differentiated and favorable safety profile","namedEntities":{"people":[{"name":"Markus Warmuth, M.D.","role":"CEO"},{"name":"Filip Janku, M.D., Ph.D.","role":"Chief Medical Officer"}],"products":["MRT-8102","QuEEN"],"companies":[{"name":"Monte Rosa Therapeutics, Inc.","ticker":"GLUE","relationship":"filer/issuer"},{"name":"Scient PR","relationship":"media relations"}],"dollarAmounts":[]},"materialImpact":{"score":4,"reasoning":"Positive Phase 1 GFORCE-1 data for lead NEK7 degrader MRT-8102 with robust target degradation (~80-90%), biomarker normalization, clean safety, and three Phase 2 programs advancing. Not a binary event but a meaningful pipeline de-risking catalyst for a clinical-stage biotech."},"tickerRelevance":{"others":[],"primary":"GLUE"},"globalImportance":45,"audienceRelevance":35,"eventTypeSecondary":[],"importanceComponents":{"tickerTier":"mid-small-cap clinical biotech","eventGravity":"positive Phase 1 data with Phase 2 catalysts","sectorWeight":"biotech clinical catalysts trade on data","eventGravityNote":"not a binary readout (Phase 1 safety/biomarker)"}},"event_type":"clinical_trial","event_type_secondary":null,"sentiment":"bullish","material_impact_score":4,"narrative":"Monte Rosa Therapeutics reported positive Phase 1 GFORCE-1 results for MRT-8102, a NEK7-directed molecular glue degrader, in 108 obese subjects with elevated cardiovascular risk.\n\nNEK7 degradation was robust and sustained (~80-90% median) across all doses, with key ASCVD biomarkers (calprotectin -56%, SAA -51%, hsCRP -85%) normalized to healthy-volunteer levels and lipoprotein(a) reduced 24%, comparable to PCSK9 inhibitors.\n\nThe drug was well tolerated with no serious adverse events and TEAE rates similar to placebo (33% vs 30%).\n\nThree Phase 2 studies are planned: GFORCE-2 in coronary artery disease (H1 2027), GEMINI-1 in gout (Q4 2026/Q1 2027, initial data H2 2027), and GALAXY-1 in hidradenitis suppurativa (H1 2027).","key_figures":{"drugName":"MRT-8102","phaseOfTrial":"Phase 1","customDimensions":{"il6_reduction":"54%","lpa_reduction":"24%","saa_reduction":"51%","hscrp_reduction":"85%","s100a12_reduction":"46%","subjects_enrolled":108,"teae_rate_mrt8102":"33%","teae_rate_placebo":"30%","fibrinogen_reduction":"28%","calprotectin_reduction":"56%","nek7_degradation_median":"80-90%","il1b_reduction_top_quartile":"37%","hmgb1_reduction_top_quartile":"40%"}},"named_entities":{"people":[{"name":"Markus Warmuth, M.D.","role":"CEO"},{"name":"Filip Janku, M.D., Ph.D.","role":"Chief Medical Officer"}],"products":["MRT-8102","QuEEN"],"companies":[{"name":"Monte Rosa Therapeutics, Inc.","ticker":"GLUE","relationship":"filer/issuer"},{"name":"Scient PR","relationship":"media relations"}],"dollarAmounts":[]},"model_name":"glm-5.3-flashx","prompt_hash":"sha256:727b4b9429a443af","schema_hash":"sha256:05005c02d9cffac9","created_at":"2026-10-01T11:00:23.707Z","global_importance":45,"audience_relevance":35,"importance_components":{"tickerTier":"mid-small-cap clinical biotech","eventGravity":"positive Phase 1 data with Phase 2 catalysts","sectorWeight":"biotech clinical catalysts trade on data","eventGravityNote":"not a binary readout (Phase 1 safety/biomarker)"}},"durationMs":7025,"modelName":"glm-5.3-flashx"}}