GLUE News & Events

Collaboration revenue in the same quarter last year was $60.65M. Net loss for the fourth quarter of 2025 was $46.1M, compared to $13.4M for the fourth quarter of 2024. Expects its cash and cash equivalents to be sufficient to fund planned operations and capital expenditures into 2029. "Monte Rosa is now on the cusp of Phase 2 trial initiations for three clinical-stage programs, each targeting expansive opportunities. Strengthened by our recent capital raise, our cash runway now extends into 2029 and enables us to fund aggressive development plans for each of our programs through multiple anticipated readouts and value inflection points," said CEO Markus Warmuth. "We recently presented clinical data from the Phase 1 study of our NEK7-directed MGD MRT-8102, demonstrating suppression of high-sensitivity C-reactive protein at rates comparable to or better than those previously reported with biologic therapies, supporting the potential of MRT-8102 to be an oral best-in-class therapeutic among agents targeting the NLRP3/IL-1/IL-6 pathway. The unblinded SAD/MAD safety data announced today, combined with the recently announced 3-month results from our long-term cynomolgus monkey toxicology study, further support the favorable safety/tolerability profile observed to date and wide therapeutic window of this drug candidate. In addition, today we released promising data from a cyno obesity study demonstrating substantial impact of NEK7 degradation on body weight and body fat composition, alone or in combination with semaglutide."

Expects its cash and cash equivalents to be sufficient to fund planned operations and capital expenditures into 2029. "Monte Rosa is now on the cusp of Phase 2 trial initiations for three clinical-stage programs, each targeting expansive opportunities. Strengthened by our recent capital raise, our cash runway now extends into 2029 and enables us to fund aggressive development plans for each of our programs through multiple anticipated readouts and value inflection points," said CEO Markus Warmuth. "We recently presented clinical data from the Phase 1 study of our NEK7-directed MGD MRT-8102, demonstrating suppression of high-sensitivity C-reactive protein (hsCRP) at rates comparable to or better than those previously reported with biologic therapies, supporting the potential of MRT-8102 to be an oral best-in-class therapeutic among agents targeting the NLRP3/IL-1/IL-6 pathway. The unblinded SAD/MAD safety data announced today, combined with the recently announced 3-month results from our long-term cynomolgus (cyno) monkey toxicology study, further support the favorable safety/tolerability profile observed to date and wide therapeutic window of this drug candidate. In addition, today we released promising data from a cyno obesity study demonstrating substantial impact of NEK7 degradation on body weight and body fat composition, alone or in combination with semaglutide."

Monte Rosa Therapeutics announced the company has entered into a supply agreement with Johnson & Johnson to evaluate MRT-2359 in combination with ERLEADA for the treatment of patients with metastatic castration-resistant prostate cancer with androgen receptor mutations in a planned Phase 2 study expected to initiate in the third quarter of 2026. MRT-2359 is an investigational, orally bioavailable, GSPT1-directed MGD discovered and developed by Monte Rosa. ERLEADA is an AR inhibitor developed by Janssen Research and Development, LLC, indicated for the treatment of patients with metastatic castration-sensitive prostate cancer and patients with non-metastatic castration-resistant prostate cancer. Under the terms of the agreement, Monte Rosa will conduct and sponsor the trial and Johnson & Johnson will provide ERLEADA as part of a supply agreement. The planned Phase 2 study of up to 25 mCRPC patients is designed to efficiently assess the efficacy and safety of MRT-2359 plus ERLEADA in mCRPC patients with AR mutations, with potential to expand the study into additional patient subsets, including patients naive to next-generation AR inhibitors, should the activity in the AR mutant patient population confirm. The study will evaluate PSA response, RECIST response, duration of response, progression-free survival, radiographic progression-free survival, and safety. Monte Rosa recently announced additional, positive data from the company's ongoing Phase 1/2 clinical study evaluating MRT-2359 in combination with enzalutamide in heavily pretreated patients with mCRPC. The data were presented at the 2026 ASCO Genitourinary Cancers Symposium on February 26, 2026.