Monte Rosa Therapeutic (GLUE) investor relations material

NEK7 and cardiovascular development

• GFORCE-1 was a four-week PK/PD biomarker study; MRT-8102 was described as safe, with measured DAMPs, IL-1β, IL-6 and CRP falling toward normal physiological levels.

• Management attributed ZEUS’s outcome to CKD-related inflammation, a broad ASCVD definition and IL-6 inhibition being too far downstream; it views NEK7 as an upstream target.

• GFORCE-2 is designed to relate FAI imaging scores to pathway inhibition using upstream markers such as calprotectin and HMGB1; management sees imaging as increasingly useful in ASCVD.

• The intended signal is reduced plaque FAI after six months, correlated with biomarkers; management said the relationship between FAI changes and phase III outcomes remains to be established.

• A future outcome study could target high-risk patients with modifiable disease and be smaller and shorter than 6,000 patients; design and whether to proceed independently or with a partner depend on phase II.

Gout and MRT-8102

• Management described gout as the most validated target indication, citing colchicine’s NLRP3 activity and clinical evidence for IL-1β blockade in flare prevention.

• GEMINI-1 is a ~60-patient study with two dose levels; treatment begins at an acute flare, with subsequent flare prevention compared against historical data.

• MRT-8102 is positioned as an oral, daily next-generation anti-inflammatory for flare prevention across gout treatment lines; management cited potential convenience and cardiovascular benefits.

• Biomarker assessments will include DAMPs, IL-1β and downstream markers, with similar profiles observed across ASCVD, gout and HS.

Hidradenitis suppurativa

• Management viewed AbbVie’s lutikizumab data as validating IL-1 biology, while noting a smaller treatment-placebo difference from phase II and an overperforming placebo arm.

• GALAXY-1 will assess lesion improvement and HiSCR75; it is expected to start in H1 next year.

• Management sees potential for small molecules as monotherapy or in combination in a disease currently dominated by biologics.