Monte Rosa Therapeutics Announces Closing of Global License Agreement with Novartis to Advance T and B Cell-modulating VAV1-directed Molecular Glue Degraders

Rhea-AI Summary

Monte Rosa Therapeutics (Nasdaq: GLUE) has closed its global exclusive development and commercialization license agreement with Novartis for VAV1-directed molecular glue degraders (MGDs), including MRT-6160. The deal includes a $150 million upfront payment and potential earnings of up to $2.1 billion in development, regulatory, and sales milestones. Novartis gains worldwide rights and will handle clinical development and commercialization from Phase 2 onwards, while Monte Rosa completes the ongoing Phase 1 study.

Monte Rosa will co-fund Phase 3 development and share U.S. profits and losses, receiving tiered royalties on ex-U.S. sales. MRT-6160 is an oral VAV1 degrader showing promise in preclinical studies for immune-mediated conditions.

Positive

• Secured $150 million upfront payment from Novartis
• Potential to earn up to $2.1 billion in milestone payments
• Retains profit-sharing rights in the U.S. market
• Will receive tiered royalties on ex-U.S. sales
• Risk and development costs transferred to Novartis from Phase 2 onwards

Negative

• Must share development costs for Phase 3 trials
• Gives up exclusive rights to VAV1 MGD portfolio

Insights

Financial Analyst

This significant licensing deal substantially strengthens Monte Rosa's financial position with an immediate $150 million cash injection and potential future payments of up to $2.1 billion in milestones. The partnership with Novartis, a major pharmaceutical company, validates Monte Rosa's molecular glue degrader technology platform and provides strong commercialization capabilities. The profit-sharing arrangement for U.S. commercialization and tiered royalties for ex-U.S. sales creates a balanced revenue structure. This deal structure, common in biotech, allows Monte Rosa to maintain significant upside while reducing development risks and costs.

Medical Research Analyst

The development of MRT-6160 as a VAV1-directed molecular glue degrader represents an innovative approach in treating immune-mediated conditions. The compound's selective targeting of VAV1, a important protein in both T and B cell signaling, could potentially offer a unique therapeutic advantage. Preclinical data showing significant cytokine reduction without off-target effects suggests a favorable safety profile. Having Novartis take over Phase 2 development leverages their extensive experience in immunology drug development, potentially accelerating the path to market.

Market Research Analyst

This partnership significantly derisks Monte Rosa's development pipeline while maintaining substantial economic interest. Novartis's commitment validates both the technology platform and market potential of VAV1-targeted therapeutics. The deal terms, including Phase 3 co-funding and U.S. profit-sharing, suggest strong confidence in the commercial prospects. For a company with a market cap of approximately $618 million, securing a deal worth potentially $2.25 billion represents a transformative transaction that could significantly impact future valuation.

BOSTON, Dec. 11, 2024 (GLOBE NEWSWIRE) -- Monte Rosa Therapeutics, Inc. (Nasdaq: GLUE), a clinical-stage biotechnology company developing novel molecular glue degrader (MGD)-based medicines, today announced the closing of the Company’s previously announced global exclusive development and commercialization license agreement with Novartis to advance VAV1-directed MGDs, including MRT-6160.

Under the terms of the agreement, Novartis will obtain exclusive worldwide rights to develop, manufacture, and commercialize MRT-6160 and other VAV1 MGDs and will be responsible for all clinical development and commercialization, starting with Phase 2 clinical studies. Monte Rosa remains responsible for completing the ongoing Phase 1 clinical study of MRT-6160.ⁱ Novartis has agreed to pay Monte Rosa $150 million up front. Monte Rosa is eligible to receive up to $2.1 billion in development, regulatory, and sales milestones, beginning upon initiation of Phase 2 studies, as well as tiered royalties on ex-U.S. net sales. 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.

MRT-6160 is a potent, highly selective, and orally bioavailable investigational degrader of VAV1, a key signaling protein downstream of both the T- and B-cell receptors. Preclinical studies have demonstrated deep degradation of VAV1, resulting in a significant decrease in cytokines linked to immune-mediated conditions, with no detectable effects on other proteins. MRT-6160 has shown promising activity in preclinical models of multiple immune-mediated conditions.^ii,iii

About Monte Rosa
Monte Rosa Therapeutics is a clinical-stage biotechnology company developing highly selective molecular glue degrader (MGD) medicines for patients living with serious diseases in the areas of oncology, autoimmune and inflammatory diseases, and more. MGDs are small molecule protein degraders that have the potential to treat many diseases that other modalities, including other degraders, cannot. Monte Rosa’s QuEEN™ (Quantitative and Engineered Elimination of Neosubstrates) discovery engine combines AI-guided chemistry, diverse chemical libraries, structural biology, and proteomics to identify degradable protein targets and rationally design MGDs with unprecedented selectivity. The QuEEN discovery engine enables access to a wide-ranging and differentiated target space of well-validated biology across multiple therapeutic areas. Monte Rosa has developed the industry’s leading pipeline of MGDs, which spans oncology, autoimmune and inflammatory disease and beyond. Monte Rosa has a global license agreement with Novartis to advance VAV1-directed molecular glue degraders and a strategic collaboration with Roche to discover and develop MGDs against targets in cancer and neurological diseases previously considered impossible to drug. For more information, visit www.monterosatx.com.

Forward-Looking Statements
This communication includes express and implied “forward-looking statements,” including forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. Forward-looking statements include all statements that are not historical facts and in some cases, can be identified by terms such as “may,” “might,” “will,” “could,” “would,” “should,” “expect,” “intend,” “plan,” “objective,” “anticipate,” “believe,” “estimate,” “predict,” “potential,” “continue,” “ongoing,” or the negative of these terms, or other comparable terminology intended to identify statements about the future. Forward-looking statements contained herein include, but are not limited to, statements about the future development and commercialization of  VAV1 MGDs, including MRT-6160 , our expectations regarding the potential clinical scope and benefit for the MRT-6160 program, including results of preclinical studies, and our expectations of timing for the program, statements around the advancement and application of our pipeline, statements about the obligations under the agreement with Novartis, as well as regarding the receipt of the development, regulatory, and sales milestones and other payments under the agreement , among others. By their nature, these statements are subject to numerous risks and uncertainties, including those risks and uncertainties set forth in our most recent Annual Report on Form 10-K for the year ended December 31, 2023, filed with the U.S. Securities and Exchange Commission on March 14, 2024, and any subsequent filings, that could cause actual results, performance or achievement to differ materially and adversely from those anticipated or implied in the statements. You should not rely upon forward-looking statements as predictions of future events. Although our management believes that the expectations reflected in our statements are reasonable, we cannot guarantee that the future results, performance, or events and circumstances described in the forward-looking statements will be achieved or occur. Recipients are cautioned not to place undue reliance on these forward-looking statements, which speak only as of the date such statements are made and should not be construed as statements of fact. We undertake no obligation to publicly update any forward-looking statements, whether as a result of new information, any future presentations, or otherwise, except as required by applicable law. Certain information contained in these materials and any statements made orally during any presentation of these materials that relate to the materials or are based on studies, publications, surveys and other data obtained from third-party sources and our own internal estimates and research. While we believe these third-party studies, publications, surveys and other data to be reliable as of the date of these materials, we have not independently verified, and make no representations as to the adequacy, fairness, accuracy or completeness of, any information obtained from third-party sources. In addition, no independent source has evaluated the reasonableness or accuracy of our internal estimates or research and no reliance should be made on any information or statements made in these materials relating to or based on such internal estimates and research.

Investors
Andrew Funderburk
ir@monterosatx.com

Media
Cory Tromblee, Scient PR
media@monterosatx.com
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ⁱ Details about the study, MRT-6160 in a First-in-human Study in Healthy Subjects, can be found at ClinicalTrials.gov under the identifier NCT06597799.
ⁱⁱ Cartwright A et al. MRT-6160, a VAV1-Directed Molecular Glue Degrader, Reduces Joint Inflammation
and Autoantibody Production in a Collagen-Induced Arthritis Autoimmune Disease Model. Poster presented at: Digestive Disease Week 2024; May 21, 2024; Washington, DC.
ⁱⁱⁱ Cartwright A et al. MRT-6160, a VAV1-Directed Molecular Glue Degrader, Inhibits Disease Progression in a T-cell Transfer Mediated Colitis Model Concomitant with Reduced Calprotectin Expression. Poster presented at: EULAR 2024 – Annual European Congress of Rheumatology; June 14, 2024; Vienna, Austria.

FAQ

What is the value of Monte Rosa's (GLUE) deal with Novartis for VAV1 MGDs?

The deal includes $150 million upfront and potential earnings of up to $2.1 billion in development, regulatory, and sales milestones, plus tiered royalties on ex-U.S. sales.

What rights does Novartis gain in the Monte Rosa (GLUE) licensing agreement?

Novartis gains exclusive worldwide rights to develop, manufacture, and commercialize MRT-6160 and other VAV1 MGDs, taking responsibility for clinical development from Phase 2 onwards.

What is Monte Rosa's (GLUE) role in the MRT-6160 development after the Novartis deal?

Monte Rosa will complete the ongoing Phase 1 clinical study, co-fund Phase 3 development, and share profits and losses for U.S. manufacturing and commercialization.

What is MRT-6160's mechanism of action in Monte Rosa's (GLUE) pipeline?

MRT-6160 is an oral degrader of VAV1, a key signaling protein in T- and B-cell receptors, showing deep degradation of VAV1 and decreased cytokines in immune-mediated conditions.