Every 8-K that Monte Rosa Therapeutics, Inc. (GLUE) has filed with the SEC in the last 24 months is listed below, newest first, and each one links through to the document itself with the summary and the scores our analysis gives it.
A 8-K covers material events a company has to report between its quarterly reports, so if you follow GLUE and want that one kind of document rather than the whole filing history, this is the page to keep. The company's other filings, of every form, are on the full GLUE filings page.
Monte Rosa Therapeutics, Inc. (GLUE) reported Phase 1 GFORCE-1 results for MRT-8102, a NEK7-directed molecular glue degrader being developed for NLRP3/IL-1-driven inflammatory diseases. The study enrolled 108 obese participants with elevated cardiovascular risk, who received once-daily doses of 5 mg, 20 mg or 40 mg, or placebo, followed by four weeks of safety follow-up after four weeks of dosing.
MRT-8102 produced median NEK7 degradation of approximately 80% to 90% across doses. After four weeks, median reductions included 56% for calprotectin, 46% for S100A12, 51% for SAA, 28% for fibrinogen, 54% for IL-6, 85% for hsCRP and 24% for lipoprotein(a). Treatment-emergent adverse events occurred in 33% of MRT-8102 participants and 30% of placebo participants; no serious adverse events were reported. Adverse events led to treatment discontinuation in 11% of the 20 mg group and 19% of the 40 mg group.
Monte Rosa expects GFORCE-2 in stable coronary artery disease to begin in H1 2027, with its six-month design pending regulatory feedback. GEMINI-1 in gout is expected in Q4 2026 or Q1 2027, and GALAXY-1 in hidradenitis suppurativa in H1 2027.
Monte Rosa Therapeutics, Inc. (GLUE) announced that collaborator Novartis has initiated a Phase 2 clinical study of the VAV1-directed molecular glue degrader MRT-6160 (DDY391) in people with Sjögren’s disease, triggering a $50 million milestone payment to Monte Rosa under their global license agreement.
Novartis holds exclusive worldwide rights to develop, manufacture and commercialize MRT-6160 and other VAV1-directed molecular glue degraders and is responsible for funding and conducting Phase 2 studies, while Monte Rosa will co-fund any Phase 3 development and share 30% of U.S. profits and losses. Monte Rosa is additionally eligible to receive up to $2.1 billion in development, regulatory and sales milestones, as well as tiered royalties on ex-U.S. net sales.
The Phase 2a/b trial is randomized, double-blind, placebo-controlled and multi-center, evaluating efficacy, safety and tolerability over up to 52 weeks of treatment to support Phase 3 dose selection. Prior Phase 1 data for MRT-6160 showed sustained, dose-dependent VAV1 degradation of greater than 90% in peripheral blood T cells and was generally well tolerated.
Monte Rosa Therapeutics reported second-quarter 2026 collaboration revenue of $9.0 million, down from $23.2 million a year earlier, as R&D spending rose to $48.0 million and G&A to $10.1 million. The quarter’s net loss widened to $43.4 million from $12.3 million.
Cash, cash equivalents, restricted cash, and marketable securities totaled $626.0 million as of June 30, 2026, which the company expects will fund operations into 2029. Clinically, enrollment and dosing in the GFORCE-1 Phase 1 study of MRT-8102 in elevated cardiovascular risk are complete, with data expected in the second half of 2026 and multiple Phase 2 trials planned in cardiometabolic risk, gout, and hidradenitis suppurativa.
Novartis has activated a Phase 2 study of MRT-6160 in Sjögren’s disease under a collaboration that could provide up to $2.1 billion in milestones, while Monte Rosa activated the MODeFIRe-1 Phase 2 study of MRT-2359 in metastatic castration-resistant prostate cancer and continues advancing cyclin E1 and CDK2-directed molecular glue degrader programs toward an expected IND filing in 2027.
Monte Rosa Therapeutics held its 2026 annual stockholder meeting, where investors voted on board elections and the company’s auditor. As of the April 16, 2026 record date, there were 84,382,573 shares of common stock outstanding.
Stockholders elected three Class II directors to serve until the 2029 annual meeting. Andrew Schiff, M.D. received 71,409,008 votes for and 741,197 withheld; Chandra P. Leo, M.D. received 71,469,933 votes for and 680,272 withheld; and Anthony Manning, Ph.D. received 56,995,916 votes for and 15,154,289 withheld. Each director election also had 3,128,885 broker non-votes.
Stockholders also ratified Deloitte & Touche LLP as the independent registered public accounting firm for the fiscal year ending December 31, 2026, with 75,171,524 votes for, 57,950 against, 49,616 abstentions and no broker non-votes. No other matters were submitted for a vote at the meeting.
Monte Rosa Therapeutics reported a first quarter 2026 net loss of $44.5 million, compared with net income of $46.9 million a year earlier, as collaboration revenue normalized after large 2025 milestone payments. Q1 2026 collaboration revenue fell to $4.2 million from $84.9 million.
Research and development expenses rose to $44.1 million and general and administrative costs to $10.2 million, reflecting expansion of clinical and discovery programs. Cash, cash equivalents, restricted cash, and marketable securities reached $671.2 million, and the company expects this balance to fund operations into 2029 while it advances multiple Phase 2 studies and new IND filings.
Monte Rosa Therapeutics reported fourth quarter and full-year 2025 results alongside major clinical and financing milestones. Collaboration revenue was $2.8 million in Q4 2025 versus $60.6 million a year earlier, and $123.7 million for 2025 versus $75.6 million in 2024. Full-year net loss improved to $38.6 million from $72.7 million despite higher R&D spending of $141.5 million.
Cash, cash equivalents, restricted cash and marketable securities were $382.1 million as of December 31, 2025. A follow-on equity offering in January 2026 raised approximately $345 million gross (about $323.8 million net), extending the company’s funding runway into 2029.
Clinically, NEK7-directed MGD MRT-8102 showed strong Phase 1 anti-inflammatory activity with CRP reductions of 85% and favorable safety in 88 treated participants, supporting multiple planned Phase 2 trials starting in 2026–2027. Oncology candidate MRT-2359 delivered a 100% PSA response rate in AR-mutant mCRPC patients in combination with enzalutamide, with a Phase 2 study with apalutamide planned for Q3 2026. Partnered VAV1-directed MGD MRT-6160 is progressing toward Novartis-led Phase 2 studies, backed by a collaboration that could yield up to $2.1 billion in milestones.
Monte Rosa Therapeutics, Inc. reported that Edmund Dunn plans to retire from his role as Senior Vice President, Corporate Controller and Principal Accounting Officer, effective April 3, 2026. The company states that his retirement is not due to any disagreement over operations, policies, or practices and that he will not receive severance payments or benefits tied to his departure.
Effective the same date, Matthew Bowen, age 37, will become Corporate Controller and Principal Accounting Officer. Bowen joined Monte Rosa’s finance department after its June 2021 initial public offering and has held roles of increasing responsibility, most recently as Director, Finance. He previously spent seven years in Ernst & Young LLP’s audit and assurance practice, primarily auditing large public companies. The filing notes there are no special arrangements, family relationships, or related-party transactions connected to his promotion.
Monte Rosa Therapeutics, Inc. entered into an underwriting agreement for an underwritten public offering of 11,125,000 shares of common stock at $24.00 per share and pre-funded warrants to purchase 1,375,000 shares at $23.9999 per warrant, with each warrant having a $0.0001 exercise price. The company also granted underwriters a 30-day option to buy up to 1,875,000 additional shares of common stock at the public offering price, less underwriting discounts and commissions.
Monte Rosa estimates net proceeds of approximately $281.6 million from this offering, excluding any proceeds from the underwriters’ option. It plans to use the cash, together with existing balances, to advance MRT-8102 in chronic inflammatory diseases including atherosclerotic cardiovascular disease, further develop its QuEENTM platform across immunology, inflammation and oncology targets, and for working capital and general corporate purposes. The offering is expected to close on or about January 12, 2026, and the company expects its cash and cash equivalents to fund planned operations and capital expenditures into 2029.
Monte Rosa Therapeutics, Inc. reported that, effective January 7, 2026, it terminated the sales agreement prospectus used for its at-the-market (“ATM”) equity program under its Form S-3 registration statement. This means the company will not sell additional shares of its common stock under the existing Open Market Sale Agreement with Jefferies LLC unless and until it files a new prospectus, prospectus supplement, or a new registration statement.
The underlying Sales Agreement with Jefferies LLC, originally dated July 1, 2022 and amended March 20, 2025, remains in full force and effect apart from the ATM prospectus termination. As of January 7, 2026, the company had issued and sold 2,955,082 shares of common stock under this arrangement, generating aggregate net proceeds of $24.2 million.
Monte Rosa Therapeutics reported positive interim results from an ongoing Phase 1 study of MRT-8102, a NEK7-directed molecular glue degrader being developed for inflammatory conditions linked to the NLRP3 inflammasome, IL-1, and IL-6.
Single ascending dose cohorts enrolled 48 subjects and multiple ascending dose cohorts enrolled 40 subjects, with 24 higher-risk cardiovascular subjects completing four weeks of dosing. Across study parts, MRT-8102 produced rapid, deep and sustained NEK7 degradation of about 80–90% in peripheral blood T cells at all dose levels.
MRT-8102 led to significant reductions in high-sensitivity CRP after single and seven-day multiple dosing. In subjects with elevated cardiovascular disease risk, four weeks of treatment reduced hsCRP by 85%, while the placebo group showed no significant change, and 94% of subjects reached hsCRP below 2 mg/L from a median baseline of 6.3 mg/L. The drug also reduced IL-1β secretion and endogenous IL-6, including a 55% median IL-6 drop in high-CRP subjects and a 75% decrease in cerebrospinal fluid IL-6 in two subjects.
The safety profile to date was described as favorable, with mild to moderate, self-resolving adverse events, no dose-dependent increase in frequency or severity, and no evidence of higher infection risk. Monte Rosa also outlined 2026 milestones, including Phase 2 starts and additional IND submissions across its immunology, inflammation, and oncology pipelines.
Monte Rosa Therapeutics reported positive interim results from a Phase 1/2 study of MRT-2359 plus enzalutamide in heavily pretreated metastatic castration-resistant prostate cancer. Among 20 patients enrolled, safety was favorable, with mainly mild or moderate gastrointestinal side effects.
Of 14 evaluable patients with non-neuroendocrine disease, 4 had androgen receptor mutations and all 4 achieved PSA responses, including 2 PSA90 responses. Two partial tumor responses were seen in this AR-mutant subset, giving a 100% disease control rate, while overall disease control among evaluable patients was 64% (9 of 14). Monte Rosa plans a Phase 2 study in up to 25 patients with AR-mutant disease anticipated to start in 2026 and expects to share updated MRT-2359 data at the ASCO Genitourinary Cancers Symposium in February.
The company also highlighted MRT-8102, a first-in-class NEK7-directed degrader for inflammatory diseases, with Phase 1 dosing underway in a cardiovascular risk cohort and interim data planned for early 2026.
Monte Rosa Therapeutics (GLUE) furnished an update on operations, announcing it has reported financial results for the quarter ended September 30, 2025. The full details are contained in a press release furnished as Exhibit 99.1.
The company also posted a revised corporate presentation to the Presentations section of its website on November 6, 2025. Information under Items 2.02 and 7.01 is furnished, not filed, and is not subject to Section 18 liability or incorporated by reference unless expressly stated.