On November 6, 2025 Monte Rosa Therapeutics, Inc. (Nasdaq: GLUE), a clinical-stage biotechnology company developing novel molecular glue degrader (MGD)-based medicines, reported business highlights and financial results for the third quarter ended September 30, 2025.

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"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

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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.
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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

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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

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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.
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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.
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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

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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

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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

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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.
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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

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Continue advancement of MRT-6160 toward Phase 2 initiation, in collaboration with Novartis.
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Share MRT-8102 Phase 1 results in H1 2026.
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Submit an IND application for a second-generation NEK7-directed MGD with enhanced CNS penetration in 2026.
Oncology programs

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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.
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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.

(Press release, Monte Rosa Therapeutics, NOV 6, 2025, View Source [SID1234659581])

On November 6, 2025 Plus Therapeutics, Inc. (Nasdaq: PSTV) (the "Company"), a clinical-stage pharmaceutical company developing targeted radiotherapeutics with advanced platform technologies for central nervous system (CNS) cancers, reported its participation at the 40th Society for Immunotherapy of Cancer (SITC) (Free SITC Whitepaper) Annual Meeting, Melanoma Research Foundation (MRF) Brain Metastases Summit 4.0 on November 9, 2025 in Alexandria, VA. Dr. Andrew Brenner, M.D., Ph.D., Professor of Medicine in the Division of Hematology and Oncology at The University of Texas Health Science Center at San Antonio will highlight the Company’s REYOBIQ and ReSPECT-LM clinical trial results in the session on leptomeningeal metastases (LM) disease.

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Recall, at the 2025 SNO/ASCO CNS Metastases conference in August, ReSPECT-LM Phase 1 single dose escalation trial data showed:

REYOBIQ produced a clinical benefit rate of over 75% in 3 clinically relevant outcome measures
RNA sequencing and circulating tumor cell reduction consistent with tumor cell death
No dose limiting toxicities were observed with an overall favorable safety profile up to and including the recommended phase 2 dose of 44.1 mCi
"Given the growing incidence and unmet need, with no approved therapies for LM, we are encouraged by the continued interest in the ReSPECT-LM data, which demonstrated excellent tolerance of REYOBIQ at much higher doses than current standard, which we believe supports its broad therapeutic range," said Dr. Brenner. "REYOBIQ has been granted FDA Fast Track and Orphan Drug Designation, with enrollment in the ReSPECT-LM Dose Optimization Trial ongoing."

About LM
Leptomeningeal metastases (LM) are a rare but severe complication of advanced cancer, affecting the fluid-lined structures of the central nervous system. LM occurs in approximately 5% of patients with metastatic cancer, with breast cancer, lung cancer, and melanoma being the most common sources. Median survival is typically 2-6 months, and effective treatment options are limited, highlighting the urgent need for novel therapies.

About REYOBIQ (rhenium Re186 obisbemeda)
REYOBIQ (rhenium Re186 obisbemeda) is a novel injectable radiotherapy specifically formulated to deliver direct targeted high dose radiation in CNS tumors in a safe, effective, and convenient manner to optimize patient outcomes. REYOBIQ has the potential to reduce off target risks and improve outcomes for CNS cancer patients, versus currently approved therapies, with a more targeted and potent radiation dose. Rhenium-186 is an ideal radioisotope for CNS therapeutic applications due to its short half-life, beta energy for destroying cancerous tissue, and gamma energy for real-time imaging. REYOBIQ is being evaluated for the treatment of recurrent glioblastoma, leptomeningeal metastases, and pediatric brain cancer in the ReSPECT-GBM, ReSPECT-LM, and ReSPECT-PBC clinical trials. ReSPECT-GBM is supported by an award from the National Cancer Institute (NCI), part of the U.S. National Institutes of Health (NIH), and ReSPECT-LM is funded by a three-year $17.6M grant by the Cancer Prevention & Research Institute of Texas (CPRIT). The Company’s ReSPECT-PBC clinical trial for pediatric brain cancer is supported by a $3 million grant from the U.S. Department of Defense’s Peer Reviewed Cancer Research Program.

(Press release, Plus Therapeutics, NOV 6, 2025, View Source;_hsenc=p2ANqtz-9wK0pEiXdCF6C_QhGr1luNoUuLy0Y0aCzdXjasFH0TXIWLb6Cl_OE8hKG707ChQCieDhElzVLmx2Jvfp8-Ij7lJUmdlw&_hsmi=388703881&utm_content=388703881&utm_source=hs_email [SID1234659609])

On November 6, 2025 Defence Therapeutics Inc. ("Defence" or the "Company"), a leading biotechnology company pioneering next-generation antibody-drug conjugate ("ADC"), reported the successful presentation of new data on its proprietary Accum platform at the 16th World ADC Conference in San Diego, USA (November 4–5, 2025).

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The presentation generated exceptional interest from both the scientific and industry communities, with attendees continuing discussions around Defence’s poster long after the official session concluded. The results presented by Dr. Maxime Parisotto, Chief Scientific Officer of Defence Therapeutics, demonstrated how Accum enhances intracellular delivery and payload release, thereby amplifying the potency and therapeutic index of ADCs.

"The response to our new data was phenomenal," said Dr. Parisotto. "It’s clear that the Accum platform addresses one of the key challenges in ADC design—efficient endosomal escape and payload delivery. We are now moving forward to test Accum across a broader range of on-market and development-stage ADCs to fully explore its potential to improve efficacy and patient outcomes."

The Company is now expanding its collaborative and internal testing programs to include multiple commercial and clinical-stage ADC constructs, aiming to validate Accum as a plug-and-play enhancer for the next generation of targeted cancer therapies.

"Our goal is to demonstrate that Accum can universally enhance the performance of ADCs, regardless of the payload or antibody used," said Dr. Mark Lambermon, Head of Quality and Operation at Defence Therapeutics who was also in attendance in San Diego. "We are engaging with leading industry partners to accelerate these evaluations and bring this transformative technology closer to patients."

The Defence team extends its gratitude to the organizers of the World ADC Conference and to the many collaborators and industry partners who joined discussions in San Diego.

(Press release, Defence Therapeutics, NOV 6, 2025, View Source;utm_medium=rss&utm_campaign=defence-announces-successful-presentation-at-the-world-adc-conference-in-san-diego-and-plans-to-expand-evaluation-of-accum-in-commercial-and-pipeline-adcs [SID1234659634])

On November 6, 2025 Alkermes plc (Nasdaq: ALKS) reported that management will participate in two upcoming investor conferences.

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Stifel 2025 Healthcare Conference
Date/Time: Thursday, Nov. 13, 2025 at 2:40 p.m. ET (7:40 p.m. GMT)

Jefferies Global Healthcare Conference in London
Date/Time: Wednesday, Nov. 19, 2025 at 11:30 a.m. ET (4:30 p.m. GMT)

The live webcasts may be accessed under the Investors tab on www.alkermes.com and will be archived for 14 days.

(Press release, Alkermes, NOV 6, 2025, View Source [SID1234659550])

On November 6, 2025 CytomX Therapeutics, Inc. (Nasdaq: CTMX), a leader in the field of masked, conditionally activated biologics, reported third quarter 2025 financial results and provided a business update.

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"CytomX continued to execute against its pipeline priorities this quarter, highlighted by robust Phase 1 expansion enrollment for CX-2051. We remain on track for a CX-2051 Phase 1 data update in Q1 2026. Looking ahead to 2026, CX-2051 is well positioned as a first-in-class EpCAM-directed, topoisomerase-1 ADC designed to address the high unmet need in CRC and a wide range of other EpCAM-expressing indications. CytomX’s top priority is to advance CX-2051 towards a potential registrational study in advanced, late-line CRC. Additionally, we continue to plan for focused investments to further unlock the potential of CX-2051, including moving into earlier lines of CRC therapy and additional EpCAM positive cancers," said Sean McCarthy, D.Phil., chief executive officer and chairman of CytomX.

Dr. McCarthy continued "We are also pleased with the dose escalation progress for our PROBODY interferon alpha-2b, CX-801, and look forward to presenting encouraging initial biomarker data at SITC (Free SITC Whitepaper) which underscore this potent masked cytokine’s therapeutic potential in combination with checkpoint inhibitors in advanced melanoma."

Q3 2025 Pipeline Program Updates:

CX-2051 (EpCAM PROBODY Topo-1 ADC)

CX-2051 Phase 1 dose expansions across the 7.2 mg/kg, 8.6 mg/kg, and 10 mg/kg doses, administered every three weeks (Q3W) are ongoing.
In Q3 2025, dose expansion enrollment continued with the goal of supporting a potential registrational study of CX-2051 monotherapy in advanced CRC.
Phase 1 study enrollment is projected to reach approximately 100 patients by the planned CX-2051 Phase 1 update in Q1 2026.
A Phase 1b CX-2051 combination study with bevacizumab in CRC is expected to start in Q1 2026, data from which is intended to inform potential late-phase development in earlier lines of CRC therapy.
Evaluation ongoing of multiple non-CRC, EpCAM-expressing tumor indications for potential future CX-2051 development.
CX-801 (PROBODY Interferon alpha-2b)

Society of Immunotherapy of Cancer (SITC) (Free SITC Whitepaper) 2025 Annual Meeting
CX-801 monotherapy biomarker data in advanced melanoma patients to be presented that support CX-801’s mechanism of action and the ongoing combination study with KEYTRUDA (pembrolizumab).
CX-801 monotherapy has been well tolerated at doses exceeding the approved dose of unmasked IFNα2b.1
Gene expression analysis of pre- and post-treatment patient tumor biopsies demonstrated consistently increased expression of interferon-stimulated genes.
Patients demonstrated evidence of T-cell and NK cell activation and upregulation of immune checkpoint genes, including PD-1 and PD-L1.
Evidence of sustained elevation of CXCL10 in the tumor but not the blood was observed, suggesting preferential CX-801 activity in the tumor versus the periphery.
PK analysis also demonstrated dose-proportional exposure of CX-801, which remained predominantly in its intact (masked) form in circulation.
The CX-801 Phase 1 study is ongoing with a focus in advanced melanoma. CX-801 monotherapy dose escalation has reached the fourth dose level.
In May 2025, Phase 1 dose escalation of CX-801 in combination with KEYTRUDA was initiated. Dose escalation of CX-801 in combination with KEYTRUDA is currently enrolling the 2nd dose level.
Initial clinical data for CX-801 in the combination with KEYTRUDA in advanced melanoma is anticipated in 2026.
KEYTRUDA is a registered trademark of Merck Sharp & Dohme LLC, a subsidiary of Merck & Co., Inc., Rahway, NJ, USA

Corporate and Financial:

Corporate:
In October 2025, announced the appointment of Rachael Lester, MBA as Senior Vice President, Chief Business Officer.
Financial:
CytomX ended the third quarter of 2025 with $143.6 million of cash, cash equivalents and investments with expected cash runway to the second quarter of 2027.
Research Pipeline and Collaborations:
CytomX has research collaborations with Bristol Myers Squibb, Amgen, Astellas, Regeneron, and Moderna. Multiple drug discovery programs continue across our research collaborations with a focus on bispecific immunotherapies, including T-cell engagers.
At SITC (Free SITC Whitepaper) 2025, preclinical data will be presented for CX-908, a dually masked PROBODY T-cell Engager targeting CDH3 and CD3. CX-908 potently induced tumor regressions in established breast and lung cancer xenograft tumor models and demonstrated a 100-fold improvement in tolerability, including significantly reduced cytokine release vs. an unmasked CDH3xCD3 molecule.

Third Quarter 2025 Financial Results:

Cash, cash equivalents and investments totaled $143.6 million as of September 30, 2025, compared to $158.1 million as of June 30, 2025.

Total revenue was $6.0 million for the quarter ended September 30, 2025, compared to $33.4 million for the quarter ended September 30, 2024. The decrease in revenue was driven primarily by the completion of our performance obligations in the Bristol Myers Squibb collaboration and a decrease in Moderna activities due to Moderna budget considerations.

Total operating expense in the third quarter of 2025 was $21.7 million compared to $29.3 million in the third quarter of 2024, a decrease of $7.6 million.

Research and development expenses were $15.3 million for the three months ended September 30, 2025, a decrease of $6.1 million compared to the corresponding period of 2024. Reduced research and development expenses were primarily due to a reduction in CX-904 spend due to program de-prioritization in Q1 2025, reduced research expenses following the Q1 2025 restructuring, and lower CX-2051 manufacturing expenses which was partially offset by the increase in CX-2051 clinical spend.

General and administrative expenses were $6.4 million for the three months ended September 30, 2025, a decrease of $1.5 million compared to the corresponding period of 2024. The decrease in general and administrative expenses was primarily driven by personnel costs as well as patent and legal expenses.

(Press release, CytomX Therapeutics, NOV 6, 2025, View Source [SID1234659566])