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Investor releaseQuarter not tagged2026-08-07Monte Rosa Therapeutics (GLUE) Is Down 30.7% After Deepening Q2 Losses And H1 Earnings Reversal
Simply Wall St.
Monte Rosa Therapeutics (GLUE) Is Down 30.7% After Deepening Q2 Losses And H1 Earnings Reversal
Monte Rosa Therapeutics, Inc. recently reported second-quarter 2026 results showing a net loss of US$43.4 million, up from US$12.3 million a year earlier, with basic and diluted loss per share widening to US$0.43 from US$0.15. For the first half of 2026, the company swung from net income of US$34.59 million to a net loss of US$87.9 million, marking a sharp reversal in its earnings profile. Next, we’ll examine how this sharp widening of losses shapes Monte Rosa Therapeutics’ investment narrative and what it may imply for investors. This technology could replace computers: discover 26 stocks that are working to make quantum computing a reality. To own Monte Rosa Therapeutics today, you need to believe that its molecular glue degrader platform and emerging clinical data can ultimately justify sustained losses and a rich valuation. The latest quarter’s US$43.4 million loss, following a similar Q1, underlines how fast cash is being consumed after the early 2026 equity raise, and helps explain the very sharp share price pullback over the past month. Near term, the key catalysts still sit around clinical readouts for MRT‑2359 and other pipeline programs, as well as any partnering activity that could offset funding needs. The new earnings print does not change those scientific milestones, but it likely sharpens the market’s focus on dilution risk, execution on trials and whether current revenue expectations remain realistic relative to an 8.7% growth forecast. However, this widening loss profile introduces a funding and dilution risk that investors should not ignore. The valuation report we've compiled suggests that Monte Rosa Therapeutics' current price could be inflated. The Simply Wall St Community’s single fair value estimate of US$29.50 contrasts with recent selling after the larger losses, reminding you that community views can differ sharply and are worth comparing with evolving business risks. Explore another fair value estimate on Monte Rosa Therapeutics - why the stock might be worth just $29.50! Disagree with this assessment? Extraordinary investment returns rarely come from following the herd, so go with your instincts. A great starting point for your Monte Rosa Therapeutics research is our analysis highlighting 1 key reward and 5 important warning signs that could impact your investment decision. Our free Monte Rosa Therapeutics research report provides…Read full documentShow less
Monte Rosa Therapeutics, Inc. recently reported second-quarter 2026 results showing a net loss of US$43.4 million, up from US$12.3 million a year earlier, with basic and diluted loss per share widening to US$0.43 from US$0.15. For the first half of 2026, the company swung from net income of US$34.59 million to a net loss of US$87.9 million, marking a sharp reversal in its earnings profile. Next, we’ll examine how this sharp widening of losses shapes Monte Rosa Therapeutics’ investment narrative and what it may imply for investors. This technology could replace computers: discover 26 stocks that are working to make quantum computing a reality. To own Monte Rosa Therapeutics today, you need to believe that its molecular glue degrader platform and emerging clinical data can ultimately justify sustained losses and a rich valuation. The latest quarter’s US$43.4 million loss, following a similar Q1, underlines how fast cash is being consumed after the early 2026 equity raise, and helps explain the very sharp share price pullback over the past month. Near term, the key catalysts still sit around clinical readouts for MRT‑2359 and other pipeline programs, as well as any partnering activity that could offset funding needs. The new earnings print does not change those scientific milestones, but it likely sharpens the market’s focus on dilution risk, execution on trials and whether current revenue expectations remain realistic relative to an 8.7% growth forecast. However, this widening loss profile introduces a funding and dilution risk that investors should not ignore. The valuation report we've compiled suggests that Monte Rosa Therapeutics' current price could be inflated. The Simply Wall St Community’s single fair value estimate of US$29.50 contrasts with recent selling after the larger losses, reminding you that community views can differ sharply and are worth comparing with evolving business risks. Explore another fair value estimate on Monte Rosa Therapeutics - why the stock might be worth just $29.50! Disagree with this assessment? Extraordinary investment returns rarely come from following the herd, so go with your instincts. A great starting point for your Monte Rosa Therapeutics research is our analysis highlighting 1 key reward and 5 important warning signs that could impact your investment decision. Our free Monte Rosa Therapeutics research report provides a comprehensive fundamental analysis summarized in a single visual - the Snowflake - making it easy to evaluate Monte Rosa Therapeutics' overall financial health at a glance. Right now could be the best entry point. These picks are fresh from our daily scans. Don't delay: Find 50 companies with promising cash flow potential yet trading below their fair value. Uncover the next big thing with 20 elite penny stocks that balance risk and reward. Invest in the nuclear renaissance through our list of 89 elite nuclear energy infrastructure plays powering the global AI revolution. This article by Simply Wall St is general in nature. We provide commentary based on historical data and analyst forecasts only using an unbiased methodology and our articles are not intended to be financial advice. It does not constitute a recommendation to buy or sell any stock, and does not take account of your objectives, or your financial situation. We aim to bring you long-term focused analysis driven by fundamental data. Note that our analysis may not factor in the latest price-sensitive company announcements or qualitative material. Simply Wall St has no position in any stocks mentioned. Companies discussed in this article include GLUE. Have feedback on this article? Concerned about the content? Get in touch with us directly. Alternatively, email [email protected]
Investor releaseQuarter not tagged2026-08-06Monte Rosa Therapeutics Announces Second Quarter 2026 Financial Results and Business Updates
GlobeNewswire
Monte Rosa Therapeutics Announces Second Quarter 2026 Financial Results and Business Updates
Completed enrollment and dosing for GFORCE-1 study of MRT-8102 in subjects with elevated cardiovascular disease (CVD) risk; readout anticipated in H2 2026 Company expects to initiate multiple MRT-8102 Phase 2 studies, including in patients with elevated atherosclerotic risk and cardiometabolic syndrome in H2 2026, in patients with gout flares in Q4 2026/Q1 2027, and in patients with moderate to severe hidradenitis suppurativa in H1 2027 MODeFIRe-1 Phase 2 study of MRT-2359 activated, in combination with apalutamide in metastatic castration-resistant prostate cancer patients (mCRPC) with androgen receptor (AR) mutations Phase 2a/b clinical trial for VAV1-directed MGD MRT-6160 (DDY391) activated in participants with Sjögren’s disease; study to be conducted by Novartis under global exclusive development and commercialization license agreement Strong balance sheet with cash, cash equivalents, restricted cash, and marketable securities of$626.0 million, expected to support operations into 2029 BOSTON, Aug. 06, 2026 (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 second quarter ended June 30, 2026. “We’re tremendously proud of our progress to date in 2026, defined by strong execution across our clinical-stage portfolio, with two Phase 2 trials activated and additional trials expected across our programs,” said Markus Warmuth, M.D., Chief Executive Officer of Monte Rosa Therapeutics. “Importantly, for our VAV1 program, Novartis recently activated a Phase 2 study evaluating MRT-6160 (DDY391) in individuals with Sjögren’s disease, representing an important step forward for this program and established collaboration. We look forward to additional Phase 2 study activations expected as part of a broader development effort to evaluate the potential of MRT-6160 across other immune-mediated diseases. In addition, the Phase 2 study of MRT-2359 in combination with apalutamide in mCRPC patients with AR mutations is now activated, and we expect to enroll our first patients imminently, positioning us to validate the strong signals of clinical activity we observed in this patient population in our Phase 1/2 trial. We will update data from the initial Phase 1/2 arm exploring MRT-2359 in advanced…Read full documentShow less
Completed enrollment and dosing for GFORCE-1 study of MRT-8102 in subjects with elevated cardiovascular disease (CVD) risk; readout anticipated in H2 2026 Company expects to initiate multiple MRT-8102 Phase 2 studies, including in patients with elevated atherosclerotic risk and cardiometabolic syndrome in H2 2026, in patients with gout flares in Q4 2026/Q1 2027, and in patients with moderate to severe hidradenitis suppurativa in H1 2027 MODeFIRe-1 Phase 2 study of MRT-2359 activated, in combination with apalutamide in metastatic castration-resistant prostate cancer patients (mCRPC) with androgen receptor (AR) mutations Phase 2a/b clinical trial for VAV1-directed MGD MRT-6160 (DDY391) activated in participants with Sjögren’s disease; study to be conducted by Novartis under global exclusive development and commercialization license agreement Strong balance sheet with cash, cash equivalents, restricted cash, and marketable securities of$626.0 million, expected to support operations into 2029 BOSTON, Aug. 06, 2026 (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 second quarter ended June 30, 2026. “We’re tremendously proud of our progress to date in 2026, defined by strong execution across our clinical-stage portfolio, with two Phase 2 trials activated and additional trials expected across our programs,” said Markus Warmuth, M.D., Chief Executive Officer of Monte Rosa Therapeutics. “Importantly, for our VAV1 program, Novartis recently activated a Phase 2 study evaluating MRT-6160 (DDY391) in individuals with Sjögren’s disease, representing an important step forward for this program and established collaboration. We look forward to additional Phase 2 study activations expected as part of a broader development effort to evaluate the potential of MRT-6160 across other immune-mediated diseases. In addition, the Phase 2 study of MRT-2359 in combination with apalutamide in mCRPC patients with AR mutations is now activated, and we expect to enroll our first patients imminently, positioning us to validate the strong signals of clinical activity we observed in this patient population in our Phase 1/2 trial. We will update data from the initial Phase 1/2 arm exploring MRT-2359 in advanced CRPC by the end of the year.” Dr. Warmuth continued: “Moving forward, we expect a catalyst-rich second half of 2026, including data from our GFORCE-1 study of MRT-8102 in subjects with elevated cardiovascular disease risk, the study having been fully enrolled in June. With these data, we look forward to deepening our understanding of MRT-8102’s clinical activity across multiple dose levels and its impact on inflammatory and cardiometabolic biomarker endpoints. In particular, we will present data on levels of damage-associated molecular patterns (DAMPs) such as calprotectin that promote local inflammation, atherosclerotic plaque instability, and rupture of plaques in individuals with ASCVD – processes not adequately addressed by IL-1/IL-6 antibodies – as well as pathologic cytokines and C-reactive protein (CRP), a well-established pharmacodynamic marker. Over the next 9 to 12 months, we expect to initiate three MRT-8102 Phase 2 studies, including our Phase 2b study, GFORCE-2, later this year, which will inform the potential of MRT-8102 to modulate key parameters of metabolic and atherosclerotic risk, liver inflammation and anemia of inflammation through both primary and secondary study endpoints, as well as GEMINI-1, our study to explore the potential of MRT-8102 to prevent recurrent gout flares following management of acute flares. In summary, we continue to be impressed by the potential of MRT-8102 to address sterile inflammation in a variety of disorders with high unmet medical need, and we continue to explore multiple promising development opportunities in that space.” RECENT HIGHLIGHTS MRT-8102, NEK7-directed MGD for inflammatory diseases driven by the NLRP3 inflammasome and IL-1 Enrollment and dosing have been completed for all subjects participating in the GFORCE-1 Phase 1 study of MRT-8102 in individuals with elevated cardiovascular disease (CVD) risk (NCT07119125). The GFORCE-1 study explored multiple dose levels in a 4-week treatment regimen and 4 weeks of safety follow-up to accelerate dose selection and development in multiple indications, including in atherosclerotic cardiovascular disease (ASCVD), gout, and hidradenitis suppurativa, with an anticipated readout in H2 2026. Based on data reported in January, in subjects with elevated CVD risk, MRT-8102 demonstrated rapid and durable reductions in systemic inflammation, including an 85% median reduction of CRP levels after four weeks of treatment. Additional biomarker data, including impact on calprotectin, an independent risk factor for ASCVD, will be reported. Monte Rosa expects to initiate multiple Phase 2 studies of MRT-8102 in indications with high unmet need and strong biologic rationale for targeting the NLRP3/IL-1 pathway: MRT-6160, VAV1-directed MGD for immune-mediated conditions Monte Rosa’s collaborator Novartis has activated a Phase 2 clinical study for the VAV1-directed MGD MRT-6160 (DDY391) in people living with Sjögren’s disease. Monte Rosa expects to receive a milestone payment upon the first patient visit in the Phase 2 clinical study. More information about the study, “A Phase 2a/b Study to Assess the Efficacy, Safety and Tolerability of DDY391 in Participants With Sjögren's Disease,” can be found at ClinicalTrials.gov, study identifier NCT07737743. Monte Rosa expects additional Phase 2 study activations as part of a broader development effort to evaluate the potential of MRT-6160 (DDY391) across immune-mediated diseases; Monte Rosa is eligible for additional Phase 2 milestones in conjunction with these study initiations. Monte Rosa has a global exclusive development and commercialization license agreement with Novartis to advance VAV1-directed MGDs, including MRT-6160 (DDY391). Monte Rosa is eligible to receive up to $2.1 billion in development, regulatory, and sales milestones, beginning upon initiation of Phase 2 studies. Novartis is responsible for conducting and funding Phase 2 studies. Monte Rosa will co-fund any Phase 3 clinical development and will share 30% of 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 metastatic CRPC Monte Rosa has activated the MODeFIRe-1 Phase 2 study of MRT-2359. The study will include up to 25 patients to efficiently assess the efficacy of MRT-2359 in combination with the second-generation AR inhibitor apalutamide in mCRPC patients with AR mutations, with potential to expand the study into additional patient subsets. Monte Rosa has a clinical supply agreement with Johnson & Johnson to support the Phase 2 trial evaluating MRT-2359 in combination with apalutamide. More information about the study, “MODeFIRe-1 (Molecular Degrader for Inhibitor Resistance): A Phase 2, Open-Label, Multicenter Study of Oral MRT-2359 in Combination with Apalutamide in Patients with Castration-Resistant Prostate Cancer,” can be found at ClinicalTrials.gov, study identifier: NCT07745361. Enrollment in the initial Phase 1/2 study expansion arm, in patients with advanced CRPC, has been completed. A total of 6 patients with AR mutation 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. Cyclin E1 and CDK2-directed MGD programs for solid tumors Monte Rosa expects to submit an IND application for its cyclin E1 (CCNE1)-directed molecular glue degrader program in 2027. Monte Rosa continues to advance its CDK2-directed MGD program for the treatment of ER+ breast cancer toward clinical development. ANTICIPATED UPCOMING MILESTONES AND DEVELOPMENT PRIORITIESImmunology and inflammation programs Readout of MRT-8102 GFORCE-1 study in subjects with elevated CVD risk anticipated in H2 2026. Initiate multiple Phase 2 studies of MRT-8102, including in elevated atherosclerotic risk patients in H2 2026, in gout flare patients in Q4 2026/Q1 2027, and in hidradenitis suppurativa patients in H1 2027. Submit an IND application for a second-generation NEK7-directed MGD in H2 2026. Monte Rosa expects its collaborator, Novartis, to initiate multiple Phase 2 studies of the VAV1-directed MGD MRT-6160 (DDY391) in immune-mediated diseases in 2026. Oncology programs Update on the initial Phase 1/2 expansion arm exploring MRT-2359 in combination with enzalutamide in advanced CRPC by the end of the year. Dose the first patient in the MODeFIRe-1 Phase 2 study of MRT-2359 in combination with apalutamide in mCRPC in Q3 2026. Submit an IND application for a cyclin E1-directed MGD in 2027. SECOND QUARTER 2026 FINANCIAL RESULTS Collaboration Revenue: Collaboration revenue for the second quarter of 2026 was $9.0 million, compared to $23.2 million for the second quarter of 2025. Collaboration revenue represents amounts earned from Monte Rosa’s collaboration and license agreements with Roche and Novartis. Research and Development (R&D) Expenses: R&D expenses for the second quarter of 2026 were $48.0 million, compared to $30.7 million for the second quarter of 2025. The increase was primarily driven by increased spending on the MRT-8102 program and on other development and discovery programs. R&D expenses included non-cash stock-based compensation of $3.3 million for the second quarter of 2026, compared to $2.9 million in the same period in 2025. General and Administrative (G&A) Expenses: G&A expenses for the second quarter of 2026 were $10.1 million compared to $8.1 million for the second quarter of 2025. G&A expenses included non-cash stock-based compensation of $2.7 million for the second quarter of 2026, compared to $2.0 million in the same period in 2025. Net Loss: Net loss for the second quarter of 2026 was $43.4 million, compared to $12.3 million for the second quarter of 2025. Cash Position and Financial Guidance: Cash, cash equivalents, restricted cash, and marketable securities as of June 30, 2026, were $626.0 million, compared to cash, cash equivalents, restricted cash, and marketable securities of $671.2 million as of March 31, 2026. The decrease of $45.2 million was primarily due to operational use of cash. Monte Rosa expects that its cash, cash equivalents, restricted cash, and marketable securities will support operations into 2029. About Monte RosaMonte 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 activation of a Phase 2 clinical study in Sjögren's disease by our collaborator Novartis, our expectations regarding the milestone payments upon Phase 2 study initiations, additional Phase 2 study activations to evaluate the potential of MRT-6160 (DDY391) across immune-mediated diseases, our eligibility to receive up to $2.1 billion in development, regulatory, and sales milestones, Novartis's responsibility for conducting and funding Phase 2 studies, our co-funding of any Phase 3 clinical development and sharing of 30% of any profits and losses associated with the manufacturing and commercialization of MRT-6160 in the U.S., and our eligibility for tiered royalties on ex-U.S. net sales, (ii) the ongoing development of our NEK7-directed MGD, referred to as MRT-8102, including the completion of enrollment and dosing for the GFORCE-1 Phase 1 study in individuals with elevated cardiovascular disease risk, anticipated readout of GFORCE-1 data in H2 2026 and our expectations to initiate multiple Phase 2 studies of MRT-8102, including the GFORCE-2 study in elevated atherosclerotic risk patients in H2 2026, the GEMINI-1 study in gout flare patients in Q4 2026/Q1 2027, and the GALAXY-1 study in hidradenitis suppurativa patients in H1 2027, (iii) the ongoing development of a second-generation NEK7-directed MGD with enhanced CNS penetration and expected IND submission in H2 2026, (iv) our ongoing clinical development of MRT-2359, including the activation of the MODeFIRe-1 Phase 2 study of MRT-2359 in combination with apalutamide in mCRPC, with potential to expand the study into additional patient subsets, 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 an IND application submission in 2027 for a cyclin E1-directed MGD, 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. 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. InvestorsAndrew [email protected] MediaCory Tromblee, Scient [email protected]
Investor releaseQuarter not tagged2026-08-06Monte Rosa Therapeutics: Q2 Earnings Snapshot
Associated Press
Monte Rosa Therapeutics: Q2 Earnings Snapshot
BOSTON (AP) — BOSTON (AP) — Monte Rosa Therapeutics Inc. (GLUE) on Thursday reported a loss of $43.4 million in its second quarter. The Boston-based company said it had a loss of 43 cents per share. The results fell short of Wall Street expectations. The average estimate of three analysts surveyed by Zacks Investment Research was for a loss of 25 cents per share. The biopharmaceutical company posted revenue of $9 million in the period, also missing Street forecasts. Three analysts surveyed by Zacks expected $25.7 million. _____ This story was generated by Automated Insights (http://automatedinsights.com/ap) using data from Zacks Investment Research. Access a Zacks stock report on GLUE at https://www.zacks.com/ap/GLUE
Investor releaseQuarter not tagged2026-05-07Monte Rosa Therapeutics: Q1 Earnings Snapshot
Associated Press
Monte Rosa Therapeutics: Q1 Earnings Snapshot
BOSTON (AP) — BOSTON (AP) — Monte Rosa Therapeutics Inc. (GLUE) on Thursday reported a loss of $44.5 million in its first quarter. The Boston-based company said it had a loss of 45 cents per share. The results missed Wall Street expectations. The average estimate of three analysts surveyed by Zacks Investment Research was for a loss of 28 cents per share. The biopharmaceutical company posted revenue of $4.2 million in the period, which also did not meet Street forecasts. Three analysts surveyed by Zacks expected $21.7 million. _____ This story was generated by Automated Insights (http://automatedinsights.com/ap) using data from Zacks Investment Research. Access a Zacks stock report on GLUE at https://www.zacks.com/ap/GLUE
Investor releaseQuarter not tagged2026-05-07Monte Rosa Therapeutics Announces First Quarter 2026 Financial Results and Business Updates
GlobeNewswire
Monte Rosa Therapeutics Announces First Quarter 2026 Financial Results and Business Updates
Interim clinical data from GFORCE-1 trial of NEK7-directed MGD MRT-8102 demonstrated profound CRP reductions in subjects with elevated CVD risk; readout of expanded GFORCE-1 trial in subjects with elevated CVD risk anticipated in H2 2026 Company expects to initiate multiple MRT-8102 Phase 2 studies, including in patients with elevated atherosclerotic risk in H2 2026, in patients with gout flares in Q4 2026/Q1 2027, and in patients with moderate to severe hidradenitis suppurativa in H1 2027 Presented positive interim Phase 1/2 clinical data of GSPT1-directed MGD MRT-2359 in combination with an AR inhibitor in mCRPC patients with AR mutations; initiation of Phase 2 study evaluating MRT-2359 in combination with apalutamide in mCRPC patients with AR mutations planned for Q3 2026 VAV1-directed MGD MRT-6160 advancing toward anticipated initiation by Novartis of multiple Phase 2 studies in immune-mediated diseases Preclinical data presented at AACR highlight a novel cyclin E1-directed MGD with superior selectivity and reduced off-target activity compared to CDK2 inhibitors; IND submission anticipated in H2 2026 Strong balance sheet with cash, cash equivalents, restricted cash, and marketable securities of $671 million, expected to support operations into 2029 BOSTON, May 07, 2026 (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, 2026. “We continue to make excellent progress advancing multiple programs through the clinic, with all three of our clinical-stage programs approaching Phase 2 trial initiations,” said Markus Warmuth, M.D., Chief Executive Officer of Monte Rosa Therapeutics. “Building on interim clinical data for our NEK7-directed MGD MRT-8102 demonstrating rapid, deep, and durable reductions in systemic inflammation, we expect to read out the GFORCE-1 study in subjects with elevated cardiovascular disease (CVD) risk this year, and to initiate three Phase 2 studies, starting in H2 2026, in diseases driven by the NLRP3/IL-1/IL-6 pathway. We also expect our collaborator Novartis to initiate multiple Phase 2 studies of our VAV1-directed MGD MRT-6160 in immune-mediated diseases this year. In addition, our oncology programs are also progressing rapidly…Read full documentShow less
Interim clinical data from GFORCE-1 trial of NEK7-directed MGD MRT-8102 demonstrated profound CRP reductions in subjects with elevated CVD risk; readout of expanded GFORCE-1 trial in subjects with elevated CVD risk anticipated in H2 2026 Company expects to initiate multiple MRT-8102 Phase 2 studies, including in patients with elevated atherosclerotic risk in H2 2026, in patients with gout flares in Q4 2026/Q1 2027, and in patients with moderate to severe hidradenitis suppurativa in H1 2027 Presented positive interim Phase 1/2 clinical data of GSPT1-directed MGD MRT-2359 in combination with an AR inhibitor in mCRPC patients with AR mutations; initiation of Phase 2 study evaluating MRT-2359 in combination with apalutamide in mCRPC patients with AR mutations planned for Q3 2026 VAV1-directed MGD MRT-6160 advancing toward anticipated initiation by Novartis of multiple Phase 2 studies in immune-mediated diseases Preclinical data presented at AACR highlight a novel cyclin E1-directed MGD with superior selectivity and reduced off-target activity compared to CDK2 inhibitors; IND submission anticipated in H2 2026 Strong balance sheet with cash, cash equivalents, restricted cash, and marketable securities of $671 million, expected to support operations into 2029 BOSTON, May 07, 2026 (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, 2026. “We continue to make excellent progress advancing multiple programs through the clinic, with all three of our clinical-stage programs approaching Phase 2 trial initiations,” said Markus Warmuth, M.D., Chief Executive Officer of Monte Rosa Therapeutics. “Building on interim clinical data for our NEK7-directed MGD MRT-8102 demonstrating rapid, deep, and durable reductions in systemic inflammation, we expect to read out the GFORCE-1 study in subjects with elevated cardiovascular disease (CVD) risk this year, and to initiate three Phase 2 studies, starting in H2 2026, in diseases driven by the NLRP3/IL-1/IL-6 pathway. We also expect our collaborator Novartis to initiate multiple Phase 2 studies of our VAV1-directed MGD MRT-6160 in immune-mediated diseases this year. In addition, our oncology programs are also progressing rapidly, in particular with a Phase 2 study initiation of MRT-2359 in metastatic castration-resistant prostate cancer (mCRPC) patients with androgen receptor (AR) mutations planned for Q3 2026, following the encouraging Phase 1/2 data we presented at ASCO GU.” RECENT HIGHLIGHTS MRT-8102, NEK7-directed MGD for inflammatory diseases driven by the NLRP3 inflammasome, IL-1, and IL-6 In January, Monte Rosa announced positive interim data from an ongoing Phase 1 clinical study evaluating MRT-8102. In subjects with elevated CVD risk, after four weeks of MRT-8102 administration, CRP levels decreased by 85%, and 94% of study participants achieved CRP levels below 2 mg/L, a threshold associated with reduced CVD risk. The Company subsequently announced unblinded safety data from the single ascending dose / multiple ascending dose (SAD/MAD) cohorts and 3-month results from the ongoing long-term toxicology study in cynomolgus monkeys support a broad therapeutic index for MRT-8102. The ongoing GFORCE-1 study of MRT-8102 in subjects with elevated CVD risk is evaluating multiple dose levels to accelerate development in atherosclerotic cardiovascular disease (ASCVD) with an anticipated readout in H2 2026. Monte Rosa expects to initiate multiple Phase 2 studies of MRT-8102 in indications with high unmet need and strong biologic rationale for targeting the NLRP3/IL-1/IL-6 pathway: A study (GFORCE-2) of MRT-8102 in patients with elevated atherosclerotic risk is expected to initiate in H2 2026 to evaluate the effect of MRT-8102 treatment for 12 weeks (plus open-label extension) on CRP levels, as well as effects on liver fat, liver inflammation, and obesity. A study of MRT-8102 in patients with gout flares is expected to initiate in Q4 2026 or Q1 2027. A study of MRT-8102 in patients with moderate to severe hidradenitis suppurativa is expected to initiate in H1 2027. MRT-6160, VAV1-directed MGD for immune-mediated conditions Advancement of MRT-6160 toward multiple Phase 2 studies in immune-mediated diseases is ongoing, in collaboration with Novartis. Results from the Phase 1, single ascending dose / multiple ascending dose (SAD/MAD) study in healthy volunteers (clinicaltrials.gov identifier NCT06597799) support a clear path into anticipated Phase 2 studies and broad potential applications in multiple immune-mediated diseases. Monte Rosa has a global exclusive development and commercialization license agreement with Novartis to advance VAV1-directed 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. Novartis is responsible for conducting and funding Phase 2 studies. Monte Rosa will co-fund any Phase 3 clinical development and will share 30% of 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 metastatic CRPC In February, Monte Rosa presented additional interim data from an ongoing Phase 1/2 clinical study evaluating MRT-2359 in combination with enzalutamide in heavily pretreated patients with mCRPC at the ASCO Genitourinary Cancers Symposium (ASCO GU). MRT-2359 is an investigational, orally bioavailable, GSPT1-directed MGD. PSA responses in patients with AR mutations expanded to 5 of 5 patients, with a 100% disease control rate, including 2 patients with RECIST partial responses and 3 with stable disease, all showing reductions in size of target lesions. Across all 15 evaluable patients, the overall RECIST disease control rate was 67%, and 10 of 15 patients showed tumor size reductions of target lesions. The combination of MRT-2359 and enzalutamide was generally well-tolerated with primarily Grade 1-2 AEs. There were no treatment discontinuations due to AEs. The Company plans to initiate a Phase 2 study (MODeFIRe-1) in 2026 of up to 25 patients to efficiently assess the efficacy of MRT-2359 in combination with the second-generation AR inhibitor apalutamide in mCRPC patients with AR mutations, with potential to expand the study into additional patient subsets. In March, Monte Rosa announced it entered into a supply agreement with Johnson & Johnson to evaluate MRT-2359 in combination with ERLEADA® (apalutamide) for the treatment of patients with mCRPC with androgen receptor (AR) mutations in its planned Phase 2 study. Cyclin E1 (CCNE1)-directed MGD program for CCNE1-amplified solid tumors Monte Rosa presented preclinical data on the potential of its potent and highly selective cyclin E1 (CCNE1)-directed molecular glue degrader, MRT-55811, to treat CCNE1-amplified solid tumors at the American Association for Cancer Research (AACR) Annual Meeting 2026. MRT-55811 induced deep tumor regressions in CCNE1-amplified in vivo models of ovarian, breast, and gastric cancers, and demonstrated superior selectivity and reduced off-target activity compared to CDK2 inhibitors. Monte Rosa expects to submit an IND application for its CCNE1 MGD program in H2 2026. The Company expects to develop this molecule in ovarian cancer and other cancer types driven by CCNE1 amplification. CDK2-directed MGD program for ER+ breast cancer Monte Rosa continues to advance its CDK2-directed MGD program for the treatment of ER+ breast cancer toward clinical development. Corporate In January, Monte Rosa closed an upsized underwritten public offering. Gross proceeds, before deducting underwriting discounts and commissions and offering expenses, were $345 million. Monte Rosa continues to progress its collaboration with Novartis to develop novel degraders for immune-mediated diseases and its collaboration with Roche to discover and develop MGDs against targets in cancer and neurological diseases previously considered impossible to drug. ANTICIPATED UPCOMING MILESTONES AND DEVELOPMENT PRIORITIES Immunology and Inflammation programs Readout of MRT-8102 GFORCE-1 study in subjects with elevated CVD risk anticipated in H2 2026. Initiate multiple Phase 2 studies of MRT-8102, including in elevated atherosclerotic risk patients in H2 2026, in gout flare patients in Q4 2026/Q1 2027, and in hidradenitis suppurativa patients in H1 2027. Submit an IND application for a second-generation NEK7-directed MGD in H2 2026. Monte Rosa expects its collaborator, Novartis, to initiate multiple Phase 2 studies of VAV1-directed MGD MRT-6160 in immune-mediated diseases in 2026. Oncology programs Initiate the MODeFIRe-1 Phase 2 study of MRT-2359 in combination with apalutamide in mCRPC in Q3 2026. Submit an IND application for a cyclin E1-directed MGD in H2 2026. FIRST QUARTER 2026 FINANCIAL RESULTS Collaboration Revenue: Collaboration revenue for the first quarter of 2026 was $4.2 million, compared to $84.9 million for the first quarter of 2025. Collaboration revenue represents amounts earned from the Company’s collaboration and license agreements with Roche and Novartis. Research and Development (R&D) Expenses: R&D expenses for the first quarter of 2026 were $44.1 million, compared to $32.2 million for the first quarter of 2025. These increases were driven by increased spending during the quarter on our MRT-8102 program and on other development and discovery programs. General and Administrative (G&A) Expenses: G&A expenses for the first quarter of 2026 were $10.2 million, compared to $8.7 million for the first quarter of 2025. These increases, which include non-cash stock-based compensation, were driven by increased headcount and expenses in support of our growth and operations as a public company. Net Loss: Net loss for the first quarter of 2026 was $44.5 million, compared to $46.9 million net income for the first quarter of 2025. Cash Position and Financial Guidance: Cash, cash equivalents, restricted cash, and marketable securities as of March 31, 2026, were $671.2 million, compared to cash, cash equivalents, restricted cash, and marketable securities of $382.1 million as of December 31, 2025. The increase of $289.1 million was primarily due to net proceeds from the underwritten public offering in January, partially offset by operational use of cash. In January 2026, the Company closed an underwritten public equity offering of $345.0 million aggregate gross proceeds. Aggregate net proceeds from the offering after deducting underwriting discounts and commissions and offering expenses were $323.8 million. Based on current cash, cash equivalents, restricted cash, and marketable securities, together with the proceeds from the January 2026 offering, the Company expects its cash and cash equivalents to be sufficient to fund planned operations and capital expenditures into 2029. 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 around the Company’s QuEEN™ discovery engine and the broad potential applications of the platform and the Company’s 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 the Company’s view of its 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, statements related to its clear path into anticipated Phase 2 studies in collaboration with Novartis and our expectations regarding the broad potential applications in multiple immune-mediated diseases, as well as our expectation that our collaborator, Novartis, will initiate multiple Phase 2 studies of VAV1-directed MGD MRT-6160 in immune-mediated diseases in 2026, (ii) the ongoing development and progress of our NEK7-directed MGD, referred to as MRT-8102, including our expectations regarding anticipated readout of data of the GFORCE-1 study in subjects with elevated CVD risk in H2 2026, as well as our plans to target initiation of multiple Phase 2 studies of MRT-8102, including in elevated atherosclerotic risk patients in H2 2026, in gout flare patients in Q4 2026/Q1 2027, and in hidradenitis suppurativa patients in H1 2027, (iii) the ongoing development of a second-generation NEK7-directed MGD and our statements around targeted IND submission in H2 2026, (iv) our ongoing clinical development of MRT-2359, statements relating to our plans to target initiation of the MODeFIRe-1 Phase 2 study of MRT-2359 in combination with the second-generation androgen receptor inhibitor apalutamide in mCRPC in Q3 2026 and the potential to expand the study into additional patient subsets, (v) statements around the progress of both our CDK2 and cyclin E1-directed MGD programs, including statements around the targeted timing of submission of an IND application in H2 2026 for a cyclin E1-directed MGD, and statements regarding the expected potential clinical benefit of MRT-55811 in CCNE1-amplified solid tumors, as well as statements related to the expected potential clinical benefit of any of our candidates, advancement and application of our platform, statements around 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 on our development programs, including our collaborations with Novartis and Roche, statements about obligations under our collaboration agreements, expectations around the receipt of any payments under such agreements and the future studies, development and commercialization of various products, statements regarding regulatory filings for our development programs, including the planned timing of such regulatory filings, such as IND applications, and potential review by regulatory authorities, our use of capital, expenses and other financial results in the future, availability of funding for existing programs through multiple anticipated Phase 2 study initiations and clinical data readouts, 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. 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 [email protected] Media Cory Tromblee, Scient PR [email protected]
Investor releaseQuarter not tagged2026-03-17Monte Rosa Therapeutics Announces Fourth Quarter and Full-Year 2025 Financial Results and Business Updates
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Monte Rosa Therapeutics Announces Fourth Quarter and Full-Year 2025 Financial Results and Business Updates
Positive interim Phase 1 data of NEK7-directed MGD MRT-8102 demonstrated profound CRP reductions in elevated CVD-risk subjects; readout of expanded part 3 CRP PoC trial (now called GFORCE-1) anticipated in H2 2026 Newly announced unblinded safety data from MRT-8102 SAD/MAD cohorts continue to support favorable safety/tolerability profile and wide therapeutic window Company plans to initiate multiple Phase 2 studies of MRT-8102, including in patients with elevated CVD-risk in H2 2026, in patients with gout flares in Q4 2026/Q1 2027, and in patients with moderate to severe hidradenitis suppurativa in H1 2027 Presented positive interim data from the Phase 1/2 clinical study of MRT-2359 in combination with enzalutamide showing 100% PSA response rate in metastatic castration-resistant prostate cancer (mCRPC) patients with AR mutations Phase 2 study initiation of MRT-2359 in combination with apalutamide in mCRPC patients with AR mutations anticipated in Q3 2026 VAV1-directed MGD MRT-6160 advancing toward anticipated initiation by Novartis of multiple Phase 2 studies in immune-mediated diseases $345 million upsized follow-on financing further strengthens balance sheet, supporting operations into 2029 and through multiple anticipated Phase 2 study initiations and clinical data readouts BOSTON, March 17, 2026 (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 fourth quarter and full year ended December 31, 2025. “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 Markus Warmuth, M.D., Chief Executive Officer of Monte Rosa Therapeutics. “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 targ…Read full documentShow less
Positive interim Phase 1 data of NEK7-directed MGD MRT-8102 demonstrated profound CRP reductions in elevated CVD-risk subjects; readout of expanded part 3 CRP PoC trial (now called GFORCE-1) anticipated in H2 2026 Newly announced unblinded safety data from MRT-8102 SAD/MAD cohorts continue to support favorable safety/tolerability profile and wide therapeutic window Company plans to initiate multiple Phase 2 studies of MRT-8102, including in patients with elevated CVD-risk in H2 2026, in patients with gout flares in Q4 2026/Q1 2027, and in patients with moderate to severe hidradenitis suppurativa in H1 2027 Presented positive interim data from the Phase 1/2 clinical study of MRT-2359 in combination with enzalutamide showing 100% PSA response rate in metastatic castration-resistant prostate cancer (mCRPC) patients with AR mutations Phase 2 study initiation of MRT-2359 in combination with apalutamide in mCRPC patients with AR mutations anticipated in Q3 2026 VAV1-directed MGD MRT-6160 advancing toward anticipated initiation by Novartis of multiple Phase 2 studies in immune-mediated diseases $345 million upsized follow-on financing further strengthens balance sheet, supporting operations into 2029 and through multiple anticipated Phase 2 study initiations and clinical data readouts BOSTON, March 17, 2026 (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 fourth quarter and full year ended December 31, 2025. “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 Markus Warmuth, M.D., Chief Executive Officer of Monte Rosa Therapeutics. “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.” “Our preclinical and clinical data corroborate the important role of NEK7 in driving lipid and metabolite-induced inflammation and support further development of MRT-8102 in cardiovascular and cardiometabolic indications,” said Filip Janku, M.D., Ph.D., Chief Medical Officer of Monte Rosa Therapeutics. “Dosing is underway in our expanded GFORCE-1 study in subjects with elevated cardiovascular disease (CVD) risk, with additional results expected in H2 2026, and we look forward to initiating multiple Phase 2 studies of MRT-8102, starting with an ASCVD study this year. We’re excited that our VAV1-directed MGD MRT-6160, in collaboration with Novartis, is advancing towards multiple Phase 2 study initiations in immune-mediated diseases. Additionally, based on the promising data from our Phase 1/2 study of MRT-2359 in combination with an AR inhibitor in mCRPC patients, we plan to initiate a new Phase 2 study this year to evaluate MRT-2359 in combination with the second-generation AR-inhibitor apalutamide in patients with AR mutations, a population with limited therapeutic options. We are very pleased to have entered into a supply agreement with Johnson & Johnson for the provision of apalutamide for this study.” RECENT HIGHLIGHTS MRT-8102, NEK7-directed MGD for inflammatory diseases driven by the NLRP3 inflammasome, IL-1, and IL-6 In January, Monte Rosa announced positive interim data from an ongoing Phase 1 clinical study evaluating MRT-8102. In subjects with elevated cardiovascular disease (CVD) risk, MRT-8102 demonstrated rapid and durable reductions in systemic inflammation. After four weeks of MRT-8102 administration, CRP levels decreased by 85%, and 94% of study participants achieved CRP levels below 2 mg/L, a threshold associated with reduced CVD risk. Single ascending dose (SAD) and multiple ascending dose (MAD) cohorts demonstrated deep and sustained NEK7 degradation at doses from 5 mg to 400 mg. Monte Rosa today announced unblinded safety data from the SAD/MAD cohorts of the Phase 1 study. In a total of 88 participants treated, there were no serious adverse events (SAEs), and no treatment-emergent adverse events (AEs) over grade 2. Rates of treatment-emergent AEs were 22% in subjects treated with MRT-8102, compared with 32% in subjects treated with placebo. The most frequent treatment-emergent AE was headache, reported in 9% of participants treated with MRT-8102 and 9% of participants treated with placebo. The data support a broad therapeutic index for MRT-8102. Monte Rosa recently provided topline 3-month results from the ongoing long-term toxicology study in cynos. No test article-related findings were reported and the no observed adverse events level (NOAEL) was the highest dose tested, a dose approximately 200 – 300-fold over the projected human efficacious dose. These findings reinforce the favorable safety and tolerability profile observed to date in the ongoing Phase 1 clinical study of MRT-8102 and in the 28-day preclinical GLP toxicology studies. In a cyno model of high-fat diet-induced obesity, daily dosing of a NEK7 MGD for 11 weeks produced an approximately 8% reduction in body weight relative to vehicle-treated animals. When combined with the GLP-1 receptor agonist semaglutide, body weight loss exceeded 23% relative to the vehicle group (versus 17% for semaglutide monotherapy). These findings are consistent with similar studies conducted with MRT-8102, both alone and in combination with semaglutide, in a mouse model of high-fat diet-induced obesity. Notably, DEXA body composition analysis of the cynos revealed preferential reductions in central abdominal fat, a depot strongly associated with increased metabolic risk, with proportionally greater loss compared with the gynoid fat depot and minimal impact on lean mass. As announced in January, the ongoing GFORCE-1 Study of MRT-8102 in subjects with elevated CVD risk has been expanded to multiple dose levels to accelerate development in atherosclerotic cardiovascular disease (ASCVD) with an anticipated readout in H2 2026. Dosing is now ongoing in the additional dose cohorts. Monte Rosa expects to initiate multiple Phase 2 studies of MRT-8102 in indications with high unmet need and strong biologic rationale for targeting the NLPR3/IL-1/IL-6 pathway: A study (GFORCE-2) of MRT-8102 in elevated CVD risk patients defined by Stage 3/4 chronic kidney disease and elevated CRP, expected to initiate in H2 2026, to evaluate the effect of MRT-8102 treatment for 12 weeks (plus open-label extension) on CRP levels, as well as effects on liver fat, liver inflammation, and obesity A study (GFORCE-3) of MRT-8102 in patients with gout flares, expected to initiate in Q4 2026 or Q1 2027 A study (GFORCE-4) of MRT-8102 in patients with moderate to severe hidradenitis suppurativa, expected to initiate in H1 2027 MRT-6160, VAV1-directed MGD for immune-mediated conditions Advancement of MRT-6160 toward multiple Phase 2 studies in immune-mediated diseases is ongoing, in collaboration with Novartis. Results from the Phase 1, single ascending dose / multiple ascending dose (SAD/MAD) study in healthy volunteers (clinicaltrials.gov identifier NCT06597799) support a clear path into anticipated Phase 2 studies and broad potential applications in multiple immune-mediated diseases. In October, Monte Rosa presented additional supportive MRT-6160 preclinical data at ACR Convergence 2025. In a preclinical autoimmune disease model characterized by chronic inflammation, autoantibody production, and multi-organ involvement, administration of MRT-6160 resulted in broad activity across an array of disease markers, including attenuated autoantibody levels and reduced skin and kidney pathology. Monte Rosa has a global exclusive development and commercialization license agreement with Novartis to advance VAV1-directed 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. Novartis is responsible for conducting and funding Phase 2 studies. Monte Rosa will co-fund any Phase 3 clinical development and will share 30% of 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 metastatic CRPC In February, Monte Rosa announced additional interim data from an ongoing Phase 1/2 clinical study evaluating MRT-2359 in combination with enzalutamide in heavily pretreated patients with mCRPC. MRT-2359 is an investigational, orally bioavailable, GSPT1-directed MGD. PSA responses in patients with AR mutations expanded to 5 of 5 patients, with a 100% disease control rate, including 2 patients with RECIST partial responses and 3 with stable disease, all showing reductions in size of target lesions. Across all 15 evaluable patients, the overall RECIST disease control rate was 67%, and 10 of 15 patients showed tumor size reductions of target lesions. The combination of MRT-2359 and enzalutamide was generally well-tolerated with primarily Grade 1-2 AEs. There were no treatment discontinuations due to AEs. The data bolster the promising results shared in December, reinforcing MRT-2359's potential in mCRPC. The Company plans to initiate a Phase 2 study in 2026 of up to 25 patients to efficiently assess the efficacy of MRT-2359 in combination with the second-generation AR inhibitor apalutamide in mCRPC patients with AR mutations, with potential to expand the study into additional patient subsets. In March, Monte Rosa announced it entered into a supply agreement with Johnson & Johnson to evaluate MRT-2359 in combination with ERLEADA® (apalutamide) for the treatment of patients with mCRPC with androgen receptor (AR) mutations in its planned Phase 2 study. Cyclin E1 and CDK2-directed MGD programs for solid tumors Monte Rosa continues to advance its cyclin E1 (CCNE1)- and CDK2-directed MGD programs for the treatment of CCNE1-amplified solid tumors and ER+ breast cancer toward clinical development. The Company expects to submit an IND application in 2026 for a cyclin E1-directed MGD. Corporate In January, Monte Rosa closed an upsized underwritten public offering of 13,000,000 shares of its common stock, including the full exercise by the underwriters of their option to purchase an additional 1,875,000 shares, at a public offering price of $24.00 per share and, in lieu of common stock to certain investors, pre-funded warrants to purchase 1,375,000 shares of common stock at a public offering price of $23.9999 per pre-funded warrant, which represents the per share public offering price of each share of common stock less the $0.0001 per share exercise price for each pre-funded warrant. The gross proceeds to Monte Rosa from the offering, before deducting underwriting discounts and commissions and offering expenses, were approximately $345 million. All of the shares and pre-funded warrants in the offering were sold by Monte Rosa. In September 2025, Monte Rosa announced a second agreement to collaborate with Novartis to develop novel degraders for immune-mediated diseases. Monte Rosa’s publicly disclosed pipeline programs are outside the scope of this agreement. Under the terms of the agreement, Monte Rosa received an upfront payment of $120 million. Monte Rosa will also receive payments to maintain the options. In total deal value, Monte Rosa is eligible to receive up to $5.7 billion, including upfront, option maintenance, preclinical milestone, option exercise, and development, regulatory, and sales milestone payments across programs, as well as tiered royalties on global net sales in the high single to low double-digit range. In December 2025, Monte Rosa achieved a preclinical milestone under its strategic collaboration and license agreement with Roche, triggering a $7 million milestone payment to Monte Rosa. Monte Rosa today announced two leadership team promotions: Magnus Walter, DPhil, to Chief Technology Officer, and Andrew Funderburk to Chief Investor Relations and Strategy Officer. ANTICIPATED UPCOMING MILESTONES AND DEVELOPMENT PRIORITIES Immunology and Inflammation disease programs Readout of MRT-8102 GFORCE-1 study in subjects with elevated CVD risk anticipated in H2 2026. Initiate multiple Phase 2 studies of MRT-8102, including in elevated CVD risk patients with Stage 3/4 chronic kidney disease in H2 2026, in gout flare patients in Q4 2026/Q1 2027, and in hidradenitis suppurativa patients in H1 2027. Submit an IND application for a second-generation NEK7-directed MGD in 2026. Monte Rosa expects its collaborator, Novartis, to initiate multiple Phase 2 studies of VAV1-directed MGD MRT-6160 in immune-mediated diseases in 2026. Oncology programs Initiate the MODeFIRe-1 Phase 2 study of MRT-2359 in combination with apalutamide in mCRPC in Q3 2026. Submit an IND application for a cyclin E1-directed MGD in 2026. FOURTH QUARTER AND FULL YEAR 2025 FINANCIAL RESULTS Collaboration Revenue: Collaboration revenue for the fourth quarter of 2025 was $2.8 million, compared to $60.6 million for the fourth quarter of 2024, and $123.7 million for the year ended December 31, 2025, as compared to $75.6 million for the year ended December 31, 2024. Collaboration revenue represents amounts earned from the Company’s collaboration and license agreements with Roche and Novartis. Research and Development (R&D) Expenses: R&D expenses for the fourth quarter of 2025 were $42.0 million, compared to $38.9 million for the fourth quarter of 2024, and $141.5 million for the year ended December 31, 2025, compared to $121.6 million for the year ended December 31, 2024. These increases were driven by increased spending during the year on our MRT-8102 program and on other development and discovery programs. General and Administrative (G&A) Expenses: G&A expenses for the fourth quarter of 2025 were $10.5 million compared to $8.8 million for the fourth quarter of 2024, and $36.4 million for the year ended December 31, 2025, compared to $35.2 million for the year ended December 31, 2024. These increases, which include non-cash stock-based compensation, were driven by increased headcount and expenses in support of our growth and operations as a public company. Net Loss: Net loss for the fourth quarter of 2025 was $46.1 million, compared to $13.4 million for the fourth quarter of 2024, and net loss for the year ended December 31, 2025, was $38.6 million, compared to $72.7 million for the year ended December 31, 2024. Cash Position and Financial Guidance: Cash, cash equivalents, restricted cash, and marketable securities as of December 31, 2025, were $382.1 million, compared to cash, cash equivalents, restricted cash, and marketable securities of $396.2 million as of September 30, 2025. The decrease of $14.1 million was primarily due to operational use of cash, partially offset by proceeds of $24.3 million from the sale of stock under our at-the-market program. In January 2026, the Company closed an underwritten public equity offering of approximately $345.0 million aggregate gross proceeds. Aggregate net proceeds from the offering after deducting underwriting discounts and commissions and offering expenses are expected to be approximately $323.8 million. Based on current cash, cash equivalents, restricted cash, and marketable securities, together with the proceeds from the 2026 Offering, the Company expects its cash and cash equivalents to be sufficient to fund planned operations and capital expenditures into 2029. 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 around the Company’s QuEEN™ discovery engine and the broad potential applications of the platform and the Company’s 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 the Company’s view of its 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, statements related to its clear path into anticipated Phase 2 studies in collaboration with Novartis and our expectations regarding the broad potential applications in multiple immune-mediated diseases, as well as our expectation that our collaborator, Novartis, will initiate multiple Phase 2 studies of VAV1-directed MGD MRT-6160 in immune-mediated diseases in 2026 (ii) the ongoing development and progress of our NEK7-directed MGD, referred to as MRT-8102, including our expectations regarding anticipated readout of data of the GFORCE-1 study in subjects with elevated CVD risk in H2 2026, as well as our expectations to initiate multiple Phase 2 studies of MRT-8102, including in elevated CVD risk patients with Stage 3/4 chronic kidney disease in H2 2026, in gout flare patients in Q4 2026/Q1 2027, and in hidradenitis suppurativa patients in H1 2027, statements around additional indications for Phase 2 studies of MRT-8102, including hidradenitis suppurativa and statement around MRT-8102’s potential to be an oral best-in-class therapeutic among agents targeting the NLRP3/IL-1/IL-6 pathway and statements relating to demonstrating suppression of high-sensitivity C-reactive protein (hsCRP) at rates comparable to or better than those previously reported with biologic therapies, (iii) the ongoing development of a second-generation NEK7-directed MGD with enhanced CNS penetration and our statements around expected IND submission in 2026, (iv) our ongoing clinical development of MRT-2359, statements relating our expectations to initiate the MODeFIRe-1 Phase 2 study of MRT-2359 in combination with the second-generation androgen receptor inhibitor apalutamide in mCRPC in Q3 2026,5 and (v) statements around the progress of both our CDK2 and cyclin E1-directed MGD programs, including statements around the timing of submission of an IND application in 2026 for a cyclin E1-directed MGD, as well as statements related to the expected potential clinical benefit of any of our candidates, advancement and application of our platform, statements around 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 the ability to optimize collaborations with industry partners on our development programs, statements about obligations under our collaboration agreements, expectations around the receipt of any payments under such agreements and the future development and commercialization of various products, statements regarding regulatory filings for our development programs, including the planned timing of such regulatory filings, such as IND applications, and potential review by regulatory authorities, our use of capital, expenses and other financial results in the future, availability of funding for existing programs through multiple anticipated Phase 2 study initiations and clinical data readouts, 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. 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 [email protected] Media Cory Tromblee, Scient PR [email protected]
Investor releaseQuarter not tagged2026-03-17Agenus (AGEN) Q4 Earnings and Revenues Surpass Estimates
Zacks
Agenus (AGEN) Q4 Earnings and Revenues Surpass Estimates
Agenus (AGEN) came out with quarterly earnings of $0.56 per share, beating the Zacks Consensus Estimate of a loss of $1.27 per share. This compares to a loss of $2.04 per share a year ago. These figures are adjusted for non-recurring items. This quarterly report represents an earnings surprise of +144.27%. A quarter ago, it was expected that this biotechnology company would post earnings of $2.63 per share when it actually produced earnings of $1.94, delivering a surprise of -26.24%. Over the last four quarters, the company has surpassed consensus EPS estimates two times. Agenus, which belongs to the Zacks Medical - Biomedical and Genetics industry, posted revenues of $34.2 million for the quarter ended December 2025, surpassing the Zacks Consensus Estimate by 17.54%. This compares to year-ago revenues of $26.84 million. The company has topped consensus revenue estimates three times over the last four quarters. The sustainability of the stock's immediate price movement based on the recently-released numbers and future earnings expectations will mostly depend on management's commentary on the earnings call. Agenus shares have lost about 1.3% since the beginning of the year versus the S&P 500's decline of 3.1%. While Agenus has outperformed the market so far this year, the question that comes to investors' minds is: what's next for the stock? There are no easy answers to this key question, but one reliable measure that can help investors address this is the company's earnings outlook. Not only does this include current consensus earnings expectations for the coming quarter(s), but also how these expectations have changed lately. Empirical research shows a strong correlation between near-term stock movements and trends in earnings estimate revisions. Investors can track such revisions by themselves or rely on a tried-and-tested rating tool like the Zacks Rank, which has an impressive track record of harnessing the power of earnings estimate revisions. Ahead of this earnings release, the estimate revisions trend for Agenus was mixed. While the magnitude and direction of estimate revisions could change following the company's just-released earnings report, the current status translates into a Zacks Rank #3 (Hold) for the stock. So, the shares are expected to perform in line with the market in the near future. You can see the complete list of today's Zacks #1 Rank…Read full documentShow less
Agenus (AGEN) came out with quarterly earnings of $0.56 per share, beating the Zacks Consensus Estimate of a loss of $1.27 per share. This compares to a loss of $2.04 per share a year ago. These figures are adjusted for non-recurring items. This quarterly report represents an earnings surprise of +144.27%. A quarter ago, it was expected that this biotechnology company would post earnings of $2.63 per share when it actually produced earnings of $1.94, delivering a surprise of -26.24%. Over the last four quarters, the company has surpassed consensus EPS estimates two times. Agenus, which belongs to the Zacks Medical - Biomedical and Genetics industry, posted revenues of $34.2 million for the quarter ended December 2025, surpassing the Zacks Consensus Estimate by 17.54%. This compares to year-ago revenues of $26.84 million. The company has topped consensus revenue estimates three times over the last four quarters. The sustainability of the stock's immediate price movement based on the recently-released numbers and future earnings expectations will mostly depend on management's commentary on the earnings call. Agenus shares have lost about 1.3% since the beginning of the year versus the S&P 500's decline of 3.1%. While Agenus has outperformed the market so far this year, the question that comes to investors' minds is: what's next for the stock? There are no easy answers to this key question, but one reliable measure that can help investors address this is the company's earnings outlook. Not only does this include current consensus earnings expectations for the coming quarter(s), but also how these expectations have changed lately. Empirical research shows a strong correlation between near-term stock movements and trends in earnings estimate revisions. Investors can track such revisions by themselves or rely on a tried-and-tested rating tool like the Zacks Rank, which has an impressive track record of harnessing the power of earnings estimate revisions. Ahead of this earnings release, the estimate revisions trend for Agenus was mixed. While the magnitude and direction of estimate revisions could change following the company's just-released earnings report, the current status translates into a Zacks Rank #3 (Hold) for the stock. So, the shares are expected to perform in line with the market in the near future. You can see the complete list of today's Zacks #1 Rank (Strong Buy) stocks here. It will be interesting to see how estimates for the coming quarters and the current fiscal year change in the days ahead. The current consensus EPS estimate is $1.65 on $103.3 million in revenues for the coming quarter and $0.54 on $213.95 million in revenues for the current fiscal year. Investors should be mindful of the fact that the outlook for the industry can have a material impact on the performance of the stock as well. In terms of the Zacks Industry Rank, Medical - Biomedical and Genetics is currently in the bottom 42% of the 250 plus Zacks industries. Our research shows that the top 50% of the Zacks-ranked industries outperform the bottom 50% by a factor of more than 2 to 1. Monte Rosa Therapeutics (GLUE), another stock in the same industry, has yet to report results for the quarter ended December 2025. This biopharmaceutical company is expected to post quarterly loss of $0.47 per share in its upcoming report, which represents a year-over-year change of -304.4%. The consensus EPS estimate for the quarter has been revised 6.5% higher over the last 30 days to the current level. Monte Rosa Therapeutics' revenues are expected to be $10.26 million, down 83.1% from the year-ago quarter. Want the latest recommendations from Zacks Investment Research? Today, you can download 7 Best Stocks for the Next 30 Days. Click to get this free report Agenus Inc. (AGEN) : Free Stock Analysis Report Monte Rosa Therapeutics, Inc. (GLUE) : Free Stock Analysis Report This article originally published on Zacks Investment Research (zacks.com). Zacks Investment Research
Investor releaseQuarter not tagged2026-03-17Monte Rosa Therapeutics: Q4 Earnings Snapshot
Associated Press Finance
Monte Rosa Therapeutics: Q4 Earnings Snapshot
BOSTON (AP) — BOSTON (AP) — Monte Rosa Therapeutics Inc. (GLUE) on Tuesday reported a loss of $46.1 million in its fourth quarter. The Boston-based company said it had a loss of 55 cents per share. The results did not meet Wall Street expectations. The average estimate of three analysts surveyed by Zacks Investment Research was for a loss of 47 cents per share. The biopharmaceutical company posted revenue of $2.8 million in the period, also falling short of Street forecasts. Three analysts surveyed by Zacks expected $10.3 million. For the year, the company reported a loss of $38.6 million, or 46 cents per share. Revenue was reported as $123.7 million. _____ This story was generated by Automated Insights (http://automatedinsights.com/ap) using data from Zacks Investment Research. Access a Zacks stock report on GLUE at https://www.zacks.com/ap/GLUE
Investor releaseQuarter not tagged2026-03-12Monte Rosa Therapeutics (GLUE) Expected to Beat Earnings Estimates: Can the Stock Move Higher?
Zacks
Monte Rosa Therapeutics (GLUE) Expected to Beat Earnings Estimates: Can the Stock Move Higher?
Wall Street expects a year-over-year decline in earnings on lower revenues when Monte Rosa Therapeutics (GLUE) reports results for the quarter ended December 2025. While this widely-known consensus outlook is important in gauging the company's earnings picture, a powerful factor that could impact its near-term stock price is how the actual results compare to these estimates. The stock might move higher if these key numbers top expectations in the upcoming earnings report. On the other hand, if they miss, the stock may move lower. While the sustainability of the immediate price change and future earnings expectations will mostly depend on management's discussion of business conditions on the earnings call, it's worth handicapping the probability of a positive EPS surprise. This biopharmaceutical company is expected to post quarterly loss of $0.47 per share in its upcoming report, which represents a year-over-year change of -304.4%. Revenues are expected to be $10.26 million, down 83.1% from the year-ago quarter. The consensus EPS estimate for the quarter has been revised 6.52% higher over the last 30 days to the current level. This is essentially a reflection of how the covering analysts have collectively reassessed their initial estimates over this period. Investors should keep in mind that an aggregate change may not always reflect the direction of estimate revisions by each of the covering analysts. Price, Consensus and EPS Surprise Estimate revisions ahead of a company's earnings release offer clues to the business conditions for the period whose results are coming out. Our proprietary surprise prediction model -- the Zacks Earnings ESP (Expected Surprise Prediction) -- has this insight at its core. The Zacks Earnings ESP compares the Most Accurate Estimate to the Zacks Consensus Estimate for the quarter; the Most Accurate Estimate is a more recent version of the Zacks Consensus EPS estimate. The idea here is that analysts revising their estimates right before an earnings release have the latest information, which could potentially be more accurate than what they and others contributing to the consensus had predicted earlier. Thus, a positive or negative Earnings ESP reading theoretically indicates the likely deviation of the actual earnings from the consensus estimate. However, the model's predictive power is significant for positive ESP readings only. A…Read full documentShow less
Wall Street expects a year-over-year decline in earnings on lower revenues when Monte Rosa Therapeutics (GLUE) reports results for the quarter ended December 2025. While this widely-known consensus outlook is important in gauging the company's earnings picture, a powerful factor that could impact its near-term stock price is how the actual results compare to these estimates. The stock might move higher if these key numbers top expectations in the upcoming earnings report. On the other hand, if they miss, the stock may move lower. While the sustainability of the immediate price change and future earnings expectations will mostly depend on management's discussion of business conditions on the earnings call, it's worth handicapping the probability of a positive EPS surprise. This biopharmaceutical company is expected to post quarterly loss of $0.47 per share in its upcoming report, which represents a year-over-year change of -304.4%. Revenues are expected to be $10.26 million, down 83.1% from the year-ago quarter. The consensus EPS estimate for the quarter has been revised 6.52% higher over the last 30 days to the current level. This is essentially a reflection of how the covering analysts have collectively reassessed their initial estimates over this period. Investors should keep in mind that an aggregate change may not always reflect the direction of estimate revisions by each of the covering analysts. Price, Consensus and EPS Surprise Estimate revisions ahead of a company's earnings release offer clues to the business conditions for the period whose results are coming out. Our proprietary surprise prediction model -- the Zacks Earnings ESP (Expected Surprise Prediction) -- has this insight at its core. The Zacks Earnings ESP compares the Most Accurate Estimate to the Zacks Consensus Estimate for the quarter; the Most Accurate Estimate is a more recent version of the Zacks Consensus EPS estimate. The idea here is that analysts revising their estimates right before an earnings release have the latest information, which could potentially be more accurate than what they and others contributing to the consensus had predicted earlier. Thus, a positive or negative Earnings ESP reading theoretically indicates the likely deviation of the actual earnings from the consensus estimate. However, the model's predictive power is significant for positive ESP readings only. A positive Earnings ESP is a strong predictor of an earnings beat, particularly when combined with a Zacks Rank #1 (Strong Buy), 2 (Buy) or 3 (Hold). Our research shows that stocks with this combination produce a positive surprise nearly 70% of the time, and a solid Zacks Rank actually increases the predictive power of Earnings ESP. Please note that a negative Earnings ESP reading is not indicative of an earnings miss. Our research shows that it is difficult to predict an earnings beat with any degree of confidence for stocks with negative Earnings ESP readings and/or Zacks Rank of 4 (Sell) or 5 (Strong Sell). For Monte Rosa Therapeutics, the Most Accurate Estimate is higher than the Zacks Consensus Estimate, suggesting that analysts have recently become bullish on the company's earnings prospects. This has resulted in an Earnings ESP of +2.13%. On the other hand, the stock currently carries a Zacks Rank of #3. So, this combination indicates that Monte Rosa Therapeutics will most likely beat the consensus EPS estimate. While calculating estimates for a company's future earnings, analysts often consider to what extent it has been able to match past consensus estimates. So, it's worth taking a look at the surprise history for gauging its influence on the upcoming number. For the last reported quarter, it was expected that Monte Rosa Therapeutics would post a loss of$0.39 per share when it actually produced a loss of -$0.33, delivering a surprise of +15.38%. Over the last four quarters, the company has beaten consensus EPS estimates four times. An earnings beat or miss may not be the sole basis for a stock moving higher or lower. Many stocks end up losing ground despite an earnings beat due to other factors that disappoint investors. Similarly, unforeseen catalysts help a number of stocks gain despite an earnings miss. That said, betting on stocks that are expected to beat earnings expectations does increase the odds of success. This is why it's worth checking a company's Earnings ESP and Zacks Rank ahead of its quarterly release. Make sure to utilize our Earnings ESP Filter to uncover the best stocks to buy or sell before they've reported. Monte Rosa Therapeutics appears a compelling earnings-beat candidate. However, investors should pay attention to other factors too for betting on this stock or staying away from it ahead of its earnings release. Another stock from the Zacks Medical - Biomedical and Genetics industry, Kyntra Bio (KYNB), is soon expected to post loss of $3.89 per share for the quarter ended December 2025. This estimate indicates a year-over-year change of -94.5%. Revenues for the quarter are expected to be $1.6 million, down 49% from the year-ago quarter. Over the last 30 days, the consensus EPS estimate for Kyntra Bio has remained unchanged. Nevertheless, the company now has an Earnings ESP of +24.07%, reflecting a higher Most Accurate Estimate. This Earnings ESP, combined with its Zacks Rank #3 (Hold), suggests that Kyntra Bio will most likely beat the consensus EPS estimate. Over the last four quarters, the company surpassed EPS estimates just once. Stay on top of upcoming earnings announcements with the Zacks Earnings Calendar. Want the latest recommendations from Zacks Investment Research? Today, you can download 7 Best Stocks for the Next 30 Days. Click to get this free report Monte Rosa Therapeutics, Inc. (GLUE) : Free Stock Analysis Report Kyntra Bio Inc (KYNB) : Free Stock Analysis Report This article originally published on Zacks Investment Research (zacks.com). Zacks Investment Research
Investor releaseQuarter not tagged2026-02-17NeoGenomics (NEO) Q4 Earnings and Revenues Surpass Estimates
Zacks
NeoGenomics (NEO) Q4 Earnings and Revenues Surpass Estimates
NeoGenomics (NEO) came out with quarterly earnings of $0.06 per share, beating the Zacks Consensus Estimate of $0.04 per share. This compares to earnings of $0.04 per share a year ago. These figures are adjusted for non-recurring items. This quarterly report represents an earnings surprise of +57.90%. A quarter ago, it was expected that this operator of cancer-focused testing laboratories would post earnings of $0.02 per share when it actually produced earnings of $0.03, delivering a surprise of +50%. Over the last four quarters, the company has surpassed consensus EPS estimates three times. NeoGenomics, which belongs to the Zacks Medical - Biomedical and Genetics industry, posted revenues of $190.17 million for the quarter ended December 2025, surpassing the Zacks Consensus Estimate by 0.90%. This compares to year-ago revenues of $172 million. The company has topped consensus revenue estimates two times over the last four quarters. The sustainability of the stock's immediate price movement based on the recently-released numbers and future earnings expectations will mostly depend on management's commentary on the earnings call. NeoGenomics shares have lost about 3.2% since the beginning of the year versus the S&P 500's decline of 0.1%. While NeoGenomics has underperformed the market so far this year, the question that comes to investors' minds is: what's next for the stock? There are no easy answers to this key question, but one reliable measure that can help investors address this is the company's earnings outlook. Not only does this include current consensus earnings expectations for the coming quarter(s), but also how these expectations have changed lately. Empirical research shows a strong correlation between near-term stock movements and trends in earnings estimate revisions. Investors can track such revisions by themselves or rely on a tried-and-tested rating tool like the Zacks Rank, which has an impressive track record of harnessing the power of earnings estimate revisions. Ahead of this earnings release, the estimate revisions trend for NeoGenomics was favorable. While the magnitude and direction of estimate revisions could change following the company's just-released earnings report, the current status translates into a Zacks Rank #2 (Buy) for the stock. So, the shares are expected to outperform the market in the near future. You can see the comple…Read full documentShow less
NeoGenomics (NEO) came out with quarterly earnings of $0.06 per share, beating the Zacks Consensus Estimate of $0.04 per share. This compares to earnings of $0.04 per share a year ago. These figures are adjusted for non-recurring items. This quarterly report represents an earnings surprise of +57.90%. A quarter ago, it was expected that this operator of cancer-focused testing laboratories would post earnings of $0.02 per share when it actually produced earnings of $0.03, delivering a surprise of +50%. Over the last four quarters, the company has surpassed consensus EPS estimates three times. NeoGenomics, which belongs to the Zacks Medical - Biomedical and Genetics industry, posted revenues of $190.17 million for the quarter ended December 2025, surpassing the Zacks Consensus Estimate by 0.90%. This compares to year-ago revenues of $172 million. The company has topped consensus revenue estimates two times over the last four quarters. The sustainability of the stock's immediate price movement based on the recently-released numbers and future earnings expectations will mostly depend on management's commentary on the earnings call. NeoGenomics shares have lost about 3.2% since the beginning of the year versus the S&P 500's decline of 0.1%. While NeoGenomics has underperformed the market so far this year, the question that comes to investors' minds is: what's next for the stock? There are no easy answers to this key question, but one reliable measure that can help investors address this is the company's earnings outlook. Not only does this include current consensus earnings expectations for the coming quarter(s), but also how these expectations have changed lately. Empirical research shows a strong correlation between near-term stock movements and trends in earnings estimate revisions. Investors can track such revisions by themselves or rely on a tried-and-tested rating tool like the Zacks Rank, which has an impressive track record of harnessing the power of earnings estimate revisions. Ahead of this earnings release, the estimate revisions trend for NeoGenomics was favorable. While the magnitude and direction of estimate revisions could change following the company's just-released earnings report, the current status translates into a Zacks Rank #2 (Buy) for the stock. So, the shares are expected to outperform the market in the near future. You can see the complete list of today's Zacks #1 Rank (Strong Buy) stocks here. It will be interesting to see how estimates for the coming quarters and the current fiscal year change in the days ahead. The current consensus EPS estimate is $0.02 on $188.18 million in revenues for the coming quarter and $0.18 on $795 million in revenues for the current fiscal year. Investors should be mindful of the fact that the outlook for the industry can have a material impact on the performance of the stock as well. In terms of the Zacks Industry Rank, Medical - Biomedical and Genetics is currently in the top 34% of the 250 plus Zacks industries. Our research shows that the top 50% of the Zacks-ranked industries outperform the bottom 50% by a factor of more than 2 to 1. One other stock from the same industry, Monte Rosa Therapeutics (GLUE), is yet to report results for the quarter ended December 2025. This biopharmaceutical company is expected to post quarterly loss of $0.45 per share in its upcoming report, which represents a year-over-year change of -295.7%. The consensus EPS estimate for the quarter has remained unchanged over the last 30 days. Monte Rosa Therapeutics' revenues are expected to be $10.26 million, down 83.1% from the year-ago quarter. Want the latest recommendations from Zacks Investment Research? Today, you can download 7 Best Stocks for the Next 30 Days. Click to get this free report NeoGenomics, Inc. (NEO) : Free Stock Analysis Report Monte Rosa Therapeutics, Inc. (GLUE) : Free Stock Analysis Report This article originally published on Zacks Investment Research (zacks.com). Zacks Investment Research
Investor releaseQuarter not tagged2025-12-16Monte Rosa Therapeutics to Present Updated MRT-2359 Phase 1/2 Study Results
GlobeNewswire
Monte Rosa Therapeutics to Present Updated MRT-2359 Phase 1/2 Study Results
Conference call and webcast to be held at 8 a.m. ET on December 16, 2025 BOSTON, Dec. 15, 2025 (GLOBE NEWSWIRE) -- Monte Rosa Therapeutics, Inc. (Nasdaq: GLUE), a clinical-stage biotechnology company developing novel molecular glue degrader (MGD)-based medicines, today announced that management will host a live conference call and webcast on Tuesday, December 16, 2025, at 8:00 a.m. ET. The webcast presentation will highlight interim clinical results from the ongoing Phase 1/2 study of the GSPT1-directed MGD MRT-2359 in heavily pretreated, metastatic castration-resistant prostate cancer (mCRPC) patients. A webcast of the presentation will be accessible via the “Events & Presentations” section of Monte Rosa’s website at ir.monterosatx.com. Registration for the conference call is available at the following link. An archived version of the webcast will be made available for 30 days following the presentation. 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. Investors Andrew Funderburk [email protected] Media Cory Tromblee, Scient PR [email protected]
Investor releaseQuarter not tagged2025-11-06Monte Rosa Therapeutics Announces Third Quarter 2025 Financial Results and Business Updates
GlobeNewswire
Monte Rosa Therapeutics Announces Third Quarter 2025 Financial Results and Business Updates
Second agreement signed with Novartis to develop novel degraders for immune-mediated diseases, providing upfront payment of $120 million plus option maintenance payments, and eligibility for option exercise payments, milestones, and tiered royalties Phase 1 study of NEK7-directed MGD MRT-8102 underway, investigating a potential novel approach to treat inflammatory diseases driven by the NLRP3 inflammasome; initial readout including data from high-CVD risk cohort on track for H1 2026 VAV1-directed MGD MRT-6160 advancing toward anticipated initiation of multiple Phase 2 studies in immune-mediated diseases Phase 1/2 study of GSPT1-directed MGD MRT-2359 advancing in heavily pretreated, metastatic castration-resistant prostate cancer (mCRPC) patients; additional results expected by year-end Strong cash position expected to fund operations through 2028, enabling multiple anticipated proof-of-concept clinical readouts across the portfolio BOSTON, Nov. 06, 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 third quarter ended September 30, 2025. “With three programs in clinical development and a highly productive drug discovery engine creating additional future opportunities, we are building a leading protein degradation company innovating in the molecular glue degrader space,” said Markus Warmuth, M.D., Chief Executive Officer of Monte Rosa Therapeutics. “In that context, our recently announced second collaboration with Novartis marks another major milestone for Monte Rosa, significantly expanding our potential impact on immune-mediated diseases. We believe this partnership further validates the breadth and versatility of our QuEEN™ discovery engine and underscores the growing recognition of MGDs as a distinct and potentially transformative therapeutic modality. Our cash runway extends beyond multiple anticipated Phase 2 readouts for MRT-8102, MRT-6160, and MRT-2359, and positions us to execute on our early-stage portfolio, including multiple undisclosed targets in Th1, Th2, and Th17-driven autoimmune conditions.” “In regard to our clinical programs, we are enrolling our Phase 1 study of MRT-8102, the only clinical-stage degrader targeting NEK7, which we believe offers a highly di…Read full documentShow less
Second agreement signed with Novartis to develop novel degraders for immune-mediated diseases, providing upfront payment of $120 million plus option maintenance payments, and eligibility for option exercise payments, milestones, and tiered royalties Phase 1 study of NEK7-directed MGD MRT-8102 underway, investigating a potential novel approach to treat inflammatory diseases driven by the NLRP3 inflammasome; initial readout including data from high-CVD risk cohort on track for H1 2026 VAV1-directed MGD MRT-6160 advancing toward anticipated initiation of multiple Phase 2 studies in immune-mediated diseases Phase 1/2 study of GSPT1-directed MGD MRT-2359 advancing in heavily pretreated, metastatic castration-resistant prostate cancer (mCRPC) patients; additional results expected by year-end Strong cash position expected to fund operations through 2028, enabling multiple anticipated proof-of-concept clinical readouts across the portfolio BOSTON, Nov. 06, 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 third quarter ended September 30, 2025. “With three programs in clinical development and a highly productive drug discovery engine creating additional future opportunities, we are building a leading protein degradation company innovating in the molecular glue degrader space,” said Markus Warmuth, M.D., Chief Executive Officer of Monte Rosa Therapeutics. “In that context, our recently announced second collaboration with Novartis marks another major milestone for Monte Rosa, significantly expanding our potential impact on immune-mediated diseases. We believe this partnership further validates the breadth and versatility of our QuEEN™ discovery engine and underscores the growing recognition of MGDs as a distinct and potentially transformative therapeutic modality. Our cash runway extends beyond multiple anticipated Phase 2 readouts for MRT-8102, MRT-6160, and MRT-2359, and positions us to execute on our early-stage portfolio, including multiple undisclosed targets in Th1, Th2, and Th17-driven autoimmune conditions.” “In regard to our clinical programs, we are enrolling our Phase 1 study of MRT-8102, the only clinical-stage degrader targeting NEK7, which we believe offers a highly differentiated approach to potentially address a wide range of inflammatory and cardio-immunology indications driven by the NLRP3 inflammasome, IL-1β and IL-6. We have recently initiated dosing a cohort of subjects with elevated cardiovascular disease (CVD) risk to evaluate changes in well-validated biomarkers such as C-reactive protein. Initial MRT-8102 data from the healthy volunteer and elevated CVD-risk subject cohorts are on track for the first half of 2026. In addition, we continue to work with Novartis to advance MRT-6160, our VAV1-directed MGD, towards Phase 2 studies across multiple indications where alternative treatment options are urgently needed. Our recent preclinical data presentation at ACR Convergence provides further support for exploration of systemic lupus erythematosus, Sjögren's disease, and rheumatoid arthritis, amongst others. In oncology, MRT-2359 continues to progress through expansion in mCRPC, and we plan to share additional data by year-end. We are also making strong progress with our programs targeting cyclin E1 and CDK2, two well-validated tumor drivers poorly addressed by conventional approaches, and we remain on track for an Investigational New Drug (IND) submission next year.” RECENT HIGHLIGHTS Collaboration with Novartis for degraders to treat immune-mediated diseases In September 2025, Monte Rosa announced a second agreement to collaborate with Novartis to develop novel degraders for immune-mediated diseases. Monte Rosa’s publicly disclosed pipeline programs are outside the scope of this agreement. Under the terms of the agreement, Monte Rosa has received an upfront payment of $120 million. Monte Rosa will also receive payments to maintain the options. In total deal value, Monte Rosa is eligible to receive up to $5.7 billion, including upfront, option maintenance, preclinical milestone, option exercise, and development, regulatory, and sales milestone payments across programs, as well as tiered royalties on global net sales in the high single to low double-digit range. MRT-8102, NEK7-directed MGD for inflammatory diseases driven by IL-1β, IL-6, and the NLRP3 inflammasome Monte Rosa continues to execute a Phase 1 study of MRT-8102, a first-in-class, NEK7-directed MGD for inflammatory diseases driven by the NLRP3 inflammasome, IL-1β, and IL-6. The ongoing study includes single ascending dose / multiple ascending dose (SAD/MAD) cohorts in healthy volunteers, as well as an additional Part 3 cohort designed to evaluate potential early proof of concept in subjects with increased CVD risk. The Company has initiated dosing in Part 3 of the study, evaluating subjects with high CVD risk. Initial Phase 1 data, including from the Part 3 cohort, are on track for H1 2026. MRT-6160, VAV1-directed MGD for immune-mediated conditions Advancement of MRT-6160 toward multiple Phase 2 studies in immune-mediated diseases is ongoing, in collaboration with Novartis. Results from the Phase 1, SAD/MAD study in healthy volunteers (clinicaltrials.gov identifier NCT06597799) support a clear path into anticipated Phase 2 studies and broad potential applications in multiple immune-mediated diseases. In October, Monte Rosa presented additional preclinical data at ACR Convergence 2025, demonstrating that in a spontaneous autoimmune disease mouse model characterized by chronic inflammation, autoantibody production, and multi-organ involvement, MRT-6160 inhibited disease pathology, including proteinuria, lymphadenopathy, skin lesion formation, autoantibody production, and organomegaly. These results provide further support for MRT-6160's potential across multiple immune-mediated diseases, including systemic lupus erythematosus, Sjögren’s disease, rheumatoid arthritis, and others. Monte Rosa has a global exclusive development and commercialization license agreement with Novartis to advance VAV1-directed 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. Novartis is responsible for conducting and funding Phase 2 studies. Monte Rosa will co-fund any Phase 3 clinical development and will share 30% of 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 Monte Rosa continues to enroll and evaluate MRT-2359 in patients with mCRPC. The Company plans to present updated clinical results in 20 to 30 patients with mCRPC and in patients with hormone receptor (HR)+ breast cancer by year-end 2025. Cyclin E1 and CDK2-directed MGD programs for treatment of solid tumors Monte Rosa continues to advance its cyclin E1 (CCNE1)- and CDK2-directed MGD programs for the treatment of CCNE1-amplified solid tumors and ER+ breast cancer toward clinical development. The Company remains on track to submit an IND application in 2026 for a CDK2 and/or cyclin E1-directed MGD. QuEEN™ (Quantitative and Engineered Elimination of Neosubstrates) discovery engine In July 2025, Monte Rosa’s publication, featured on the cover of Science, showcased the Company’s proprietary QuEEN™ AI/ML-powered discovery engine. The findings significantly expand the targetable protein space for MGD drug discovery, unlocking new opportunities to address previously undruggable therapeutic targets. Monte Rosa continues to progress its strategic collaboration with Roche to discover and develop MGDs against targets in cancer and neurological diseases previously considered impossible to drug. ANTICIPATED UPCOMING MILESTONES AND DEVELOPMENT PRIORITIES Immunology and Inflammation disease programs Continue advancement of MRT-6160 toward Phase 2 initiation, in collaboration with Novartis. Share MRT-8102 Phase 1 results in H1 2026. Submit an IND application for a second-generation NEK7-directed MGD with enhanced CNS penetration in 2026. Oncology programs Share updated MRT-2359 Phase 1/2 study data in heavily pretreated mCRPC patients and in patients with HR+ breast cancer by year-end 2025. Submit an IND application for a CDK2 and/or cyclin E1-directed MGD in 2026. THIRD QUARTER 2025 FINANCIAL RESULTS Collaboration Revenue: Collaboration revenue for the third quarter of 2025 was $12.8 million, compared to $9.2 million for the third quarter of 2024. Collaboration revenue represents amounts earned from our collaboration and license agreements with Roche and Novartis. Research and Development (R&D) Expenses: R&D expenses for the third quarter of 2025 were $36.7 million, compared to $27.6 million for the third quarter of 2024. These increases were driven by the successful achievement of key milestones in our R&D organization, including the advancement of MRT-8102 to enter the clinic, the continuation of the MRT-2359 clinical study, continued program activities for MRT-6160 in preparation for Phase 2 studies, the progression of our preclinical pipeline, including research performed in connection with our collaboration with Roche, and the continued development of the Company’s QuEEN™ discovery engine. Non-cash stock-based compensation constituted $2.5 million of R&D expenses for the third quarter of 2025, compared to $2.6 million in the same period in 2024. General and Administrative (G&A) Expenses: G&A expenses for the third quarter of 2025 were $9.1 million compared to $8.1 million for the third quarter of 2024. G&A expenses included non-cash stock-based compensation of $1.9 million for the third quarter of 2025, compared to $1.7 million in the same period in 2024. Net Loss: Net loss for the third quarter of 2025 was $27.1 million, compared to a net loss of $23.9 million for the third quarter of 2024. Cash Position and Financial Guidance: Cash, cash equivalents, restricted cash, and marketable securities as of September 30, 2025, were $396.2 million, compared to cash, cash equivalents, restricted cash, and marketable securities of $295.5 million as of June 30, 2025. The increase of $100.7 million was primarily due to a $120.0 million non-refundable upfront payment the Company received from Novartis in September 2025. The Company also received from Novartis $9.7 million for value added taxes related to the transaction, which is included in the Company’s accounts payable balance as of September 30, 2025 and is expected to be remitted to the Swiss government in the fourth quarter of 2025. During October 2025, the Company sold 2,955,082 shares of common stock in an at-the-market offering for aggregate gross proceeds of $25.0 million, or aggregate net proceeds of $23.9 million after deducting sales agent discounts, commissions, and other offering costs. Based on current cash, cash equivalents, restricted cash, marketable securities, and certain anticipated Roche and Novartis collaboration revenue, the Company expects its cash and cash equivalents to be sufficient to fund planned operations and capital expenditures through 2028. About MRT-6160 MRT-6160 is a potent, highly selective, and orally bioavailable investigational molecular glue degrader of VAV1, which in preclinical studies has shown deep degradation of its target with no detectable effects on other proteins. VAV1 is a key signaling protein downstream of both the T- and B-cell receptors. VAV1 expression is restricted to immune cells, including T and B cells. MRT-6160 has shown promising activity in preclinical models of multiple immune-mediated conditions. In a Phase 1, single ascending dose / multiple ascending dose (SAD/MAD) study in healthy subjects (clinicaltrials.gov identifier NCT06597799), MRT-6160 demonstrated sustained, dose-dependent VAV1 degradation in peripheral blood T and B cells after single and multiple dose administration. MRT-6160 also substantially inhibited secretion of inflammatory cytokines from whole blood derived T and B cells following ex vivo stimulation. Under the terms of an agreement announced in October 2024, Novartis has exclusive worldwide rights to develop, manufacture and commercialize MRT-6160 and other VAV1 MGDs. 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. About MRT-8102 MRT-8102 is a potent, highly selective, and orally bioavailable investigational molecular glue degrader (MGD) that targets NEK7 for the treatment of inflammatory diseases linked to NLRP3, IL-1β, and IL-6 dysregulation. NEK7 has been shown to be required for NLRP3 inflammasome assembly, activation and IL-1β release both in vitro and in vivo. Aberrant NLRP3 inflammasome activation and the subsequent release of active IL-1β and interleukin-18 (IL-18) has been implicated in multiple inflammatory disorders, including cardiovascular disease, gout, osteoarthritis, neurologic disorders including Parkinson’s disease and Alzheimer’s disease, and metabolic disorders. In a non-human primate model, MRT-8102 was shown to potently, selectively, and durably degrade NEK7, and resulted in near-complete reductions of IL-1β and caspase-1 following ex vivo stimulation of whole blood. MRT-8102 has demonstrated a considerable safety margin (>200-fold exposure margin over projected human efficacious dose) in GLP toxicology studies. MRT-8102 is currently being investigated in a Phase 1 study (clinicaltrials.gov identifier NCT07119125) in healthy participants and participants at elevated cardiovascular disease risk. About MRT-2359 MRT-2359 is a potent, highly selective, and orally bioavailable investigational molecular glue degrader (MGD) of GSPT1. MYC transcription factors (c-MYC, L-MYC and N-MYC) are well-established drivers of human cancers that maintain high levels of protein translation, which is critical for uncontrolled cell proliferation and tumor growth. Preclinical studies have shown this addiction to MYC-induced protein translation creates a dependency on GSPT1. By inducing degradation of GSPT1, MRT-2359 is designed to exploit this vulnerability, disrupting the protein synthesis machinery, leading to anti-tumor activity in MYC-driven tumors. MRT-2359 is being investigated in an ongoing Phase 1/2 study (clinicaltrials.gov identifier NCT05546268) in solid tumors, including castration-resistant prostate cancer (CRPC). In heavily pretreated CRPC patients, a patient group characterized by widespread expression of c-MYC, MRT-2359 demonstrated encouraging early signals of clinical response. 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 around the Company’s QuEEN™ discovery engine and the broad potential applications of the platform and the Company’s 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, unlocking new opportunities to address previously undruggable therapeutic targets, statements about the Company’s view of its potential to rationally design MGDs with unprecedented selectivity and its potential impact on immune-mediated diseases, statements around the breadth and versatility of our QuEEN™ discovery engine and the growing recognition of MGDs as a distinct and potentially transformative therapeutic modality, 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, statements related to its clear path into anticipated Phase 2 studies in collaboration with Novartis and our expectations regarding the broad potential applications in multiple immune-mediated diseases, including systemic lupus erythematosus, Sjögren’s disease, rheumatoid arthritis, and others, (ii) the ongoing development and progress of our NEK7-directed MGD, referred to as MRT-8102, including our expectations regarding initial Phase 1 data in the first half of 2026 and statements regarding our beliefs that MRT-8102 offers a highly differentiated approach to potentially address a wide range of inflammatory and cardio-immunology indications, (iii) the ongoing development of a second-generation NEK7-directed MGD optimized for CNS penetration and our statements around expected IND submission in 2026, and (iv) our ongoing clinical development of MRT-2359, statements regarding the timing for data readouts by year-end 2025 and around MRT-2359’s potential to provide therapeutic benefit to patients resistant to androgen receptor inhibitors, including those with AR alterations, as well as statements related to the expected potential clinical benefit of any of our candidates, advancement and application of our platform, statements around 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 the ability to optimize collaborations with industry partners on our development programs, statements about obligations under our collaboration agreements, expectations around the receipt of any payments under such agreements and the future development and commercialization of various products, statements regarding regulatory filings for our development programs, including the planned timing of such regulatory filings, such as IND applications, and potential review by regulatory authorities, our use of capital, expenses and other financial results in the future, availability of funding for existing programs, ability to fund operations through 2028 beyond multiple anticipated Phase 2 readouts for MRT-8102, MRT-6160, and MRT-2359, statements around our cash runway positioning us to execute on our early-stage portfolio including multiple undisclosed targets in Th1, Th2, and Th17-driven autoimmune conditions, statements around 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, 2024, filed with the U.S. Securities and Exchange Commission on March 20, 2025, 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 [email protected] Media Cory Tromblee, Scient PR [email protected]

