Monte Rosa Therapeutics Announces First Quarter 2025 Financial Results and Business Updates

VAV1-directed MRT-6160 program advancing toward multiple Phase 2 studies, enabled by Phase 1 SAD/MAD study data supporting broad potential application in immune-mediated diseases

MRT-2359 Phase 1/2 study data demonstrate encouraging signals of clinical response in heavily pretreated castration-resistant prostate cancer patients resistant to AR therapy; additional results expected in H2 2025

MRT-8102, a NEK7-directed molecular glue degrader targeting diseases driven by IL-1<BETA> and the NLRP3 inflammasome, on track for IND filing in H1 2025

Cyclin E1 (CCNE1) and CDK2-directed MGD programs for the treatment of CCNE1-driven solid tumors and ER+ breast cancer advancing toward the clinic; IND submission anticipated in 2026

Strong cash position expected to fund operations into 2028 through multiple anticipated proof-of-concept clinical readouts

BOSTON, May 08, 2025 (GLOBE NEWSWIRE) -- Monte Rosa Therapeutics, Inc. (Nasdaq: GLUE), a clinical-stage biotechnology company developing novel molecular glue degrader (MGD)-based medicines, today reported business highlights and financial results for the first quarter ended March 31, 2025.

"We've made significant progress across our entire portfolio in the development of our only-in-class and first-in-class molecular glue degrader therapeutics, targeting diseases poorly addressed by conventional pharmaceutical approaches," said Markus Warmuth, M.D., Chief Executive Officer of Monte Rosa Therapeutics. "As highlighted in our recent pipeline update, our MRT-6160 Phase 1 study results support the broad potential application of this molecule as a novel treatment approach for immune-mediated diseases, and we are working diligently to advance the program into Phase 2 studies alongside our collaborators at Novartis. For our GSPT1 program, based on encouraging preliminary data from our ongoing Phase 1/2 study of MRT-2359 in MYC-driven solid tumors, we are focused on castration-resistant prostate cancer, an exciting opportunity in a population with widespread c-MYC expression. Study enrollment is ongoing, and we expect to report additional clinical data in H2 2025. Lastly, we continue to make excellent progress with our earlier stage programs. Our NEK7 program, targeting inflammatory diseases driven by IL-1<BETA> and the NLRP3 inflammasome, is on track, and we plan to file an IND submission for MRT-8102 in the first half of this year. Recent preclinical data for our CDK2-directed MGD highlight the substantially greater tumor regression achieved with our MGD combined with standard of care therapies compared to standard of care alone. We look forward to an IND submission for our CDK2 and/or CCNE1 cell cycle programs next year."

RECENT HIGHLIGHTS

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

   -- In March 2025, Monte Rosa announced clinical results from its MRT-6160 
      Phase 1, single ascending dose / multiple ascending dose (SAD/MAD) study 
      in healthy volunteers (clinicaltrials.gov identifier NCT06597799). The 
      results support a clear path into anticipated Phase 2 studies and broad 
      potential applications in multiple immune-mediated diseases. Further 
      development of MRT-6160 toward Phase 2 studies is ongoing, in 
      collaboration with Novartis. 
 
   -- Monte Rosa has a global exclusive development and commercialization 
      license agreement with Novartis to advance VAV1 MGDs including MRT-6160. 
      Monte Rosa is eligible to receive up to $2.1 billion in development, 
      regulatory, and sales milestones, beginning upon initiation of Phase 2 
      studies. Monte Rosa will co-fund any Phase 3 clinical development and 
      will share 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 MYC-driven solid tumors

   -- In March 2025, Monte Rosa provided updated clinical results in evaluating 
      the safety, pharmacodynamics, and clinical activity of MRT-2359 in 
      various tumor types. The Company has determined castration-resistant 
      prostate cancer (CRPC) to be the primary MRT-2359 development focus. The 
      Company continues to enroll and evaluate patients with CRPC, with the 
      potential to expand enrollment to 20-30 patients if a positive efficacy 
      signal continues to be observed, and expects to present additional 
      results in H2 2025. Monte Rosa also continues to enroll and evaluate 
      patients with HR+ breast cancer and expects to present additional results 
      for this cohort in H2 2025. 

NEK7-directed MGDs for inflammatory and CNS diseases driven by IL-1<BETA> and the NLRP3 inflammasome

   -- Monte Rosa has successfully completed GLP tox studies for MRT-8102, a 
      first-in-class, NEK7-directed MGD for the treatment of inflammatory 
      diseases driven by interleukin-1<BETA> (IL-1<BETA>) and the NLRP3 
      inflammasome, supporting a considerable safety margin. The Company is on 
      track to submit an IND application for MRT-8102 in H1 2025 and plans to 
      initiate Phase 1 healthy volunteer and proof-of-concept studies in 
      individuals with high levels of C-reactive protein $(CRP.NZ)$ and in 
      cardio-immunology indications. The Company continues to evaluate future 
      Phase 2 proof-of-concept studies in gout, pseudogout (calcium 
      pyrophosphate deposition disease), and osteoarthritis. 

Cyclin E1 and CDK2-directed MGD programs for treatment of solid tumors

   -- In April 2025, Monte Rosa presented preclinical data on the potential of 
      its highly selective CDK2-directed molecular glue degrader, MRT-51443, to 
      treat HR-positive/HER2-negative breast cancer at the American Association 
      for Cancer Research (AACR) Annual Meeting 2025. MRT-51443 demonstrated 
      superior anti-tumor activity in HR-positive/HER2-negative breast cancer 
      models when combined with CDK4/6 inhibition and anti-estrogen therapy as 
      compared to the standard-of-care combination of CDK4/6 inhibition and 
      anti-estrogen therapy. Results also showed that MRT-51443 displayed 
      superior selectivity compared to clinical-stage CDK2 inhibitors. 

QuEEN$(TM)$ (Quantitative and Engineered Elimination of Neosubstrates) discovery engine

   -- Monte Rosa is advancing novel discovery programs for immunology and 
      inflammation targets that the Company believes have the potential for 
      highly differentiated, oral MGDs degrading undruggable targets in 
      critical I&I pathways. These may include programs with the potential to 
      improve upon the clinical profile of cell therapies, such as CAR-T, or 
      biologics, such as FcRn inhibitors. 

ANTICIPATED UPCOMING MILESTONES AND DEVELOPMENT PRIORITIES

   -- Continue advancement of MRT-6160 toward Phase 2 initiation, in 
      collaboration with Novartis. 
 
   -- Share additional MRT-2359 Phase 1/2 study data in CRPC patients resistant 
      to androgen receptor $(AR)$ therapy and in patients with HR+ breast cancer 
      in H2 2025. 
 
   -- Submit an IND application for MRT-8102 in H1 2025. 
 
   -- Submit an IND application for the second-generation NEK7-directed MGD 
      with enhanced CNS penetration in 2026. 
 
   -- Submit an IND application for a CDK2 and/or cyclin E1-directed MGD in 
      2026. 

FIRST QUARTER 2025 FINANCIAL RESULTS

Collaboration revenue: Collaboration revenue for the first quarter of 2025 was $84.9 million and $1.1 million for the quarter ended March 31, 2024. Collaboration revenue represents amounts earned from our collaboration and license agreements with Roche and Novartis, primarily revenue recognized from the Novartis $150 million upfront payment in the fourth quarter of 2024 based on progress made on our performance obligations defined in the Novartis License Agreement.

Research and Development (R&D) Expenses: R&D expenses for the first quarter of 2025 were $32.2 million, compared to $27.0 million for the first quarter of 2024. These increases were driven by the successful achievement of key milestones in our R&D organization, including the continuation of the MRT-2359 clinical study, the progression and growth of our preclinical pipeline, including research performed in connection with our collaboration with Roche, the advancement of MRT-6160 to enter the clinic, and the continued development of the Company's QuEEN(TM) discovery engine. Approximately $1.0 million included in R&D expenses are to be reimbursed pursuant to our license agreement with Novartis. Non-cash stock-based compensation constituted $3.1 million of R&D expenses for Q1 2025, compared to $2.7 million in the same period in 2024.

General and Administrative (G&A) Expenses: G&A expenses for the first quarter of 2025 were $8.7 million compared to $9.0 million for the first quarter of 2024. G&A expenses included non-cash stock-based compensation of $2.2 million for the first quarter of 2025, compared to $2.2 million in the same period in 2024.

Net Income (Loss): Net income for the first quarter of 2025 was $46.9 million, compared to a net loss of $32.0 million for the first quarter of 2024.

Cash Position and Financial Guidance: Cash, cash equivalents, restricted cash, and marketable securities as of March 31, 2025, were $331 million, compared to cash, cash equivalents, restricted cash, and marketable securities of $377 million as of December 31, 2024. The decrease of $46 million was primarily due to the operational use of cash and one-time payments not recorded in operating expenses, including $12.2 million of value-added tax (VAT) collected from Novartis in the fourth quarter of 2024 in connection with the Novartis $150 million upfront payment and remitted to the Swiss Federal Tax Administration in the first quarter of 2025.

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