Positive GFORCE-1 Phase 1 results showed MRT-8102 reduced key pathogenic drivers of atherosclerotic cardiovascular disease (ASCVD) to levels comparable to healthy volunteers across all three dose levels, with treatment-emergent adverse event rates comparable to placebo; Phase 2 initiation in coronary artery disease anticipated in H1 2027
Initiation of Phase 2 study of MRT-8102 in gout expected in Q4 2026, with data update expected in H2 2027; additional Phase 2 initiation in hidradenitis suppurativa anticipated in H1 2027
Initiated MODeFIRe-1 Phase 2 study of MRT-2359 in combination with apalutamide in heavily pretreated metastatic castration-resistant prostate cancer (mCRPC) patients with androgen receptor (AR) mutations; Phase 2 data update expected in 2027; updated Phase 1/2 study data expected this year
Novartis initiated Phase 2a/b studies of VAV1-directed MGD MRT-6160 (DDY391) in Sjögren’s disease and psoriatic arthritis, triggering a total of
Strong balance sheet with cash, cash equivalents, restricted cash, and marketable securities of
“The last quarter marks a tremendously important step forward for our clinical portfolio, with a positive readout from the GFORCE-1 study of MRT-8102, the initiation of Phase 2 development for MRT-2359, and the advancement of our partnered VAV1 program into two Phase 2 studies,” said
RECENT HIGHLIGHTS
MRT-8102, NEK7-directed MGD for inflammatory diseases driven by NEK7/NLRP3 and IL-1
- In October, Monte Rosa reported positive results from GFORCE-1 (NCT07119125), a Phase 1 study of MRT-8102 in 108 obese subjects with elevated cardiovascular disease risk. Across all three dose levels, MRT-8102 achieved median NEK7 degradation of approximately 80% to 90%. MRT-8102 also resulted in substantial reductions of IL-1ß as well as HMGB1, calprotectin, S100A12, and SAA, damage-associated molecular patterns (DAMPs) linked to pathogenic biology within atherosclerotic plaques and vessel walls. MRT-8102 was well tolerated, with no serious adverse events, adverse event rates similar to placebo, and no evidence of increased infection risk.
- With dose selection informed by the GFORCE-1 data, Monte Rosa plans to initiate three Phase 2 studies of MRT-8102:
- GEMINI-1, a Phase 2 study in patients with gout, is expected to initiate in Q4 2026. The study will evaluate prevention of flare recurrence following management of acute flares, with initial data expected in H2 2027.
- GFORCE-2, a focused Phase 2b study in patients with stable coronary artery disease and residual inflammation, is expected to initiate in H1 2027. The study is expected to evaluate imaging-based coronary artery plaque assessment, such as fat attenuation index (FAI), along with NLRP3 genetics and molecular drivers of local disease pathogenesis and systemic inflammation, to inform the design of an innovative and efficient Phase 3 study focused on the most disease-modifiable patient population.
- GALAXY-1, a Phase 2 study in patients with moderate to severe hidradenitis suppurativa, is expected to initiate in H1 2027.
- Due to prioritization of the MRT-8102 Phase 2 study initiations, Investigational New Drug (IND) submission for the next-generation NEK7 MGD is now anticipated in 2027.
MRT-2359, GSPT1-directed MGD for mCRPC
- In August, Monte Rosa dosed the first patient in MODeFIRe-1 (NCT07745361), a Phase 2 study of MRT-2359 in combination with apalutamide in AR-mutant mCRPC patients who received prior treatment with a second-generation AR inhibitor. The study will enroll up to 25 patients, with MRT-2359 administered orally at 0.5 mg on a 21 days on, 7 days off schedule. Endpoints include PSA response, RECIST response, duration of response, radiographic progression-free survival, PSA progression-free survival, and safety. Monte Rosa has a clinical supply agreement with Johnson & Johnson to support the study.
- Enrollment in the initial Phase 1/2 study expansion arm, in patients with mCRPC, has been completed. A total of 6 patients with AR mutations were enrolled and treated with MRT-2359 in combination with enzalutamide. Monte Rosa plans to provide an update on this patient subset by the end of the year. Interim data were presented at the ASCO Genitourinary Cancers Symposium (ASCO GU) in February.
MRT-6160 (DDY391), VAV1-directed MGD for immune-mediated conditions
- In September, Monte Rosa announced achievement of a milestone associated with its collaborator Novartis initiating a global Phase 2a/b randomized, double-blind, placebo-controlled study (NCT07737743), evaluating the efficacy, safety, and tolerability of up to 52 weeks of treatment with MRT-6160 (DDY391) in participants with Sjögren’s disease. The first patient visit triggered a
$50 million milestone payment to Monte Rosa. - In October, Monte Rosa announced achievement of an additional milestone associated with Novartis initiating a second Phase 2 study of MRT-6160 (DDY391) in participants with active moderate to severe psoriatic arthritis (PsA). The Phase 2a/b randomized, double-blind, placebo-controlled, multicenter study (NCT07801495) will evaluate the efficacy, safety, tolerability, and dose-response relationship of MRT-6160 (DDY391). The first patient visit triggered a
$37.5 million milestone payment to Monte Rosa. - The Sjögren’s and PsA studies are the first two of several studies expected for MRT-6160 (DDY391). Under its global exclusive development and commercialization license agreement with Novartis, Monte Rosa is eligible for additional Phase 2 study initiation milestone payments.
CDK2 and Cyclin E1-directed MGD programs for solid tumors
- Monte Rosa expects to submit IND applications for its CDK2 and cyclin E1 (CCNE1)-directed MGD programs in 2027.
ANTICIPATED UPCOMING MILESTONES AND DEVELOPMENT PRIORITIES
Immunology and inflammation programs
- Initiate GEMINI-1 Phase 2 study of MRT-8102 in gout in Q4 2026, with initial data expected in H2 2027.
- Initiate GFORCE-2 Phase 2b study of MRT-8102 in stable coronary artery disease in H1 2027.
- Initiate GALAXY-1 Phase 2 study of MRT-8102 in moderate to severe hidradenitis suppurativa in H1 2027.
- Monte Rosa expects its collaborator, Novartis, to initiate additional Phase 2 studies of MRT-6160 (DDY391) in immune-mediated diseases.
Oncology programs
- Provide a clinical data update on the initial Phase 1/2 expansion arm exploring MRT-2359 in combination with enzalutamide in mCRPC by the end of 2026.
- Provide a clinical data update on the MODeFIRe-1 Phase 2 study of MRT-2359 in combination with apalutamide in mCRPC patients with AR mutations in 2027.
- Submit an IND application for a CDK2-directed MGD in 2027.
- Submit an IND application for a CCNE1-directed MGD in 2027.
THIRD QUARTER 2026 FINANCIAL RESULTS
Collaboration Revenue: Collaboration revenue for the third quarter of 2026 was
Research and Development (R&D) Expenses: R&D expenses for the third quarter of 2026 were
General and Administrative (G&A) Expenses: G&A expenses for the third quarter of 2026 were
Net Income (Loss): Net income for the third quarter of 2026 was
Cash Position and Financial Guidance: Cash, cash equivalents, restricted cash, and marketable securities as of
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. 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 rationally design MGDs with unprecedented selectivity. Monte Rosa has developed the industry’s leading pipeline of first-in-class and only-in-class MGDs, spanning autoimmune and inflammatory diseases, oncology, and beyond, with three programs in the clinic. Monte Rosa has ongoing collaborations with leading pharmaceutical companies in the areas of immunology, oncology, and neurology. 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 our ability to grow our product pipeline, our ability to successfully complete research and further development and commercialization of our drug candidates in current or future indications, including the timing and results of our clinical trials and our ability to conduct and complete clinical trials, statements regarding our progress and speed of development of only-in-class and first-in-class molecular glue degrader therapeutics, statements about our QuEEN™ discovery engine and the broad potential applications of the platform and our ability to create long-term value through focused pipeline execution and strategic collaborations, as well as to expand the targetable protein space for MGD drug discovery, statements about our potential to rationally design MGDs with unprecedented selectivity, statements about the advancement and timeline of our preclinical and clinical programs, pipeline and the various products therein, including (i) the ongoing development of our VAV1-directed degrader, referred to as MRT-6160 (DDY391), including the initiation of Phase 2 clinical studies in Sjögren's disease and psoriatic arthritis by our collaborator Novartis, our expectations regarding the milestone payments triggered by the initiation of such Phase 2 studies, additional Phase 2 study activations expected to evaluate the potential of MRT-6160 (DDY391) across immune-mediated diseases, our eligibility for additional Phase 2 study initiation milestone payments, (ii) the ongoing development of our NEK7-directed MGD, referred to as MRT-8102, including the positive results from the GFORCE-1 Phase 1 study and the clinical significance of the data observed, statements regarding the potential of MRT-8102 to normalize local and systemic pathologic drivers of ASCVD and to provide differentiated clinical impact across NEK7/NLRP3-driven inflammatory diseases, including compared with targeting individual downstream cytokines, our expectations to initiate multiple Phase 2 studies of MRT-8102, including the GEMINI-1 study in gout patients in Q4 2026 with initial data expected in H2 2027, the GFORCE-2 Phase 2b study in patients with stable coronary artery disease and residual inflammation in H1 2027, including use of coronary artery imaging, NLRP3 genetics and biomarkers to identify a disease-modifiable patient population and inform the design of a potential Phase 3 study, and the GALAXY-1 study in moderate to severe hidradenitis suppurativa patients in H1 2027, statements regarding dose selection informed by GFORCE-1 data for further development across various NLRP3-driven diseases, statements regarding the potential of MRT-8102 in gout, (iii) the ongoing development of a next-generation NEK7-directed MGD and expected IND submission in 2027, (iv) our ongoing clinical development of MRT-2359, including the initiation of the MODeFIRe-1 Phase 2 study of MRT-2359 in combination with apalutamide in mCRPC patients with AR mutations, with potential to expand the study into additional patient subsets, our plans to provide updated data from the initial Phase 1/2 study expansion arm in patients with metastatic CRPC by the end of the year, statements regarding the clinical significance of the data observed and the potential of MRT-2359 to benefit patients with mCRPC with AR mutations, and our clinical supply agreement with Johnson & Johnson to support such trial, and (v) progress of our CDK2 and cyclin E1-directed MGD programs, including the timing of IND application submissions in 2027 for CDK2-directed and cyclin E1-directed MGDs, as well as statements related to the expected potential clinical benefit of any of our candidates, advancement and application of our platform, our ability to capitalize on and potential benefits resulting from our research and translational insights, including announcements related to preclinical programs, as well as our ability to optimize collaborations with industry partners, statements about obligations under our collaboration agreements, expectations around the receipt of payments under such agreements and the future development and commercialization of various products, statements regarding regulatory filings, including the planned timing of such filings, and potential review by regulatory authorities, our use of capital, expenses and other financial results in the future, ability to fund operations and capital expenditures into 2029, as well as our expectations of success for our programs, strength of collaboration relationships and the strength of our financial position, 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, 2025, filed with the U.S. Securities and Exchange Commission on March 17, 2026, 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, as well as the risk that outcomes of preclinical studies may not be predictive of clinical trial results and the risk that initial or interim results from a clinical trial may not be predictive of the final results of the trial or the results of future trials. 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.
| Condensed Consolidated Balance Sheets | ||||||||||
| (in thousands, except share amounts) | ||||||||||
| (unaudited) | ||||||||||
| 2026 | 2025 | |||||||||
| Assets | ||||||||||
| Current assets: | ||||||||||
| Cash and cash equivalents | $ | 45,180 | $ | 129,883 | ||||||
| Marketable securities | 532,546 | 247,221 | ||||||||
| Collaboration receivable | 50,000 | 7,000 | ||||||||
| Other receivables | 7,624 | 4,600 | ||||||||
| Prepaid expenses and other current assets | 4,715 | 4,481 | ||||||||
| Total current assets | 640,065 | 393,185 | ||||||||
| Property and equipment, net | 28,632 | 25,986 | ||||||||
| Operating lease right-of-use assets | 23,343 | 24,386 | ||||||||
| Restricted cash | 4,918 | 4,954 | ||||||||
| Other long-term assets | 767 | 148 | ||||||||
| Total assets | $ | 697,725 | $ | 448,659 | ||||||
| Liabilities and stockholders’ equity | ||||||||||
| Current liabilities: | ||||||||||
| Accounts payable | $ | 3,347 | $ | 3,550 | ||||||
| Accrued expenses and other current liabilities | 33,414 | 26,694 | ||||||||
| Current deferred revenue | 21,098 | 29,571 | ||||||||
| Current portion of operating lease liability | 4,187 | 4,397 | ||||||||
| Total current liabilities | 62,046 | 64,212 | ||||||||
| Deferred revenue, net of current | 102,261 | 111,332 | ||||||||
| Defined benefit plan liability | 5,131 | 5,265 | ||||||||
| Operating lease liability, net of current | 32,079 | 34,794 | ||||||||
| Total liabilities | 201,517 | 215,603 | ||||||||
| Stockholders’ equity | ||||||||||
| Common stock, | 9 | 7 | ||||||||
| Additional paid-in capital | 1,064,442 | 714,090 | ||||||||
| Accumulated other comprehensive loss | (6,192 | ) | (3,827 | ) | ||||||
| Accumulated deficit | (562,051 | ) | (477,214 | ) | ||||||
| Total stockholders’ equity | 496,208 | 233,056 | ||||||||
| Total liabilities and stockholders’ equity | $ | 697,725 | $ | 448,659 | ||||||
| Consolidated Statements of Income (Loss) | ||||||||||||||||
| (in thousands) (unaudited) | ||||||||||||||||
| Three months ended | Nine months ended | |||||||||||||||
| 2026 | 2025 | 2026 | 2025 | |||||||||||||
| Collaboration revenue | $ | 54,366 | $ | 12,768 | $ | 67,544 | $ | 120,891 | ||||||||
| Operating expenses: | ||||||||||||||||
| Research and development | 45,363 | 36,678 | 137,396 | 99,521 | ||||||||||||
| General and administrative | 10,942 | 9,065 | 31,251 | 25,863 | ||||||||||||
| Total operating expenses | 56,305 | 45,743 | 168,647 | 125,384 | ||||||||||||
| Loss from operations | (1,939 | ) | (32,975 | ) | (101,103 | ) | (4,493 | ) | ||||||||
| Other income: | ||||||||||||||||
| Interest income | 5,625 | 2,746 | 17,132 | 9,253 | ||||||||||||
| Foreign currency exchange gain (loss) | 93 | (29 | ) | 110 | 1,534 | |||||||||||
| Gain on disposal of property and equipment | — | — | — | 59 | ||||||||||||
| Total other income | 5,718 | 2,717 | 17,242 | 10,846 | ||||||||||||
| Net income (loss) before income taxes | $ | 3,779 | $ | (30,258 | ) | $ | (83,861 | ) | $ | 6,353 | ||||||
| Income tax (provision) benefit | (716 | ) | 3,177 | (976 | ) | 1,156 | ||||||||||
| Net income (loss) | $ | 3,063 | $ | (27,081 | ) | $ | (84,837 | ) | $ | 7,509 | ||||||
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