Nurix Therapeutics Reports Third Quarter 2025 Financial Results and Provides a Corporate Update

On October 9, 2025 Nurix Therapeutics, Inc. (Nasdaq: NRIX), a clinical-stage biopharmaceutical company focused on the discovery, development and commercialization of targeted protein degradation medicines, reported financial results for the fiscal quarter ended August 31, 2025, and highlighted significant progress across its clinical programs and strategic collaborations (Press release, Nurix Therapeutics, OCT 9, 2025, View Source [SID1234656538]).

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"Nurix is preparing to initiate pivotal studies for bexobrutideg in relapsed/refractory CLL patients in the fourth quarter of 2025 and we have outlined our plans for potential accelerated approval with a single arm study as well as a confirmatory randomized control Phase 3 study for full approval," said Arthur T. Sands, M.D., Ph.D., president and chief executive officer of Nurix. "We also continue to advance our autoimmune disease drug pipeline, including the IRAK4 degrader with Gilead, GS-6791, which is currently in healthy volunteer studies, and with the STAT6 degrader with Sanofi, which is currently in IND enabling studies. With a strong wholly owned pipeline and world-class partnerships, Nurix is well positioned to establish degrader-based medicines as a new standard of care in both cancer and autoimmune diseases."

Recent Business Highlights

Outlined bexobrutideg clinical development plans for pivotal trials:
Nurix announced plans to conduct a single arm study of bexobrutideg for potential accelerated approval in relapsed/refractory CLL patients to commence in H2 2025. In addition, Nurix described the design of a randomized controlled Phase 3 trial of bexobrutideg compared to an investigator’s choice control arm consisting of bendamustine and rituximab, idelalisib and rituximab, or pirtobrutinib.

Data presented at the European Academy of Dermatology and Venereology (EADV) 2025 Congress:
At EADV in September 2025, Nurix and collaboration partner Gilead presented preclinical findings for GS-6791, a novel, selective oral IRAK4 degrader. The data demonstrated potent degradation of IRAK4 in immune and epithelial cells, blocking IL-1 and IL-36 signaling pathways implicated in autoimmune and inflammatory diseases. In vivo, GS-6791 suppressed cytokine production and improved disease measures in a mouse model of dermatitis. These results highlight the differentiated mechanism of IRAK4 degradation compared with kinase inhibition and support the potential of GS-6791 to deliver efficacy across a range of inflammatory conditions.

Encore data presented at the Society of Hematologic Oncology (SOHO) 2025 Annual Meeting in chronic lymphocytic leukemia:
At SOHO in September 2025, Nurix presented encore Phase 1a data for bexobrutideg in patients with relapsed or refractory chronic lymphocytic leukemia (CLL). Among 47 response-evaluable patients, bexobrutideg achieved an ORR of 80.9%, including one complete response. Responses were rapid, with a median time to first response of 1.9 months and continued to deepen with longer treatment. Durable activity was observed across high-risk subgroups, including patients with TP53, PLCG2, and BTK mutations as well as those with CNS involvement. Bexobrutideg was well tolerated, with no dose-limiting toxicities and no new atrial fibrillation or flutter. These results support advancement of bexobrutideg into pivotal studies planned to initiate in the second half of 2025.

Encore data presented at the Society of Hematologic Oncology (SOHO) 2025 Annual Meeting in Waldenström macroglobulinemia:
At SOHO in September 2025, Nurix presented encore data from its ongoing Phase 1 trial of bexobrutideg in patients with relapsed or refractory Waldenström macroglobulinemia (WM). In 19 response-evaluable patients, bexobrutideg achieved a high objective response rate (ORR) of 84.2%, with responses observed across patients harboring MYD88 and CXCR4 mutations. Responses were rapid, durable, and associated with deep reductions in serum IgM levels. Bexobrutideg was well tolerated, with a safety profile consistent with prior reports, including no dose-limiting toxicities and no atrial fibrillation. These findings underscore the potential of BTK degraders to overcome BTKi resistance and provide meaningful benefit to heavily pretreated WM patients.

Upcoming Program Highlights*

Bexobrutideg: Building on the recent positive data in CLL and WM, Nurix anticipates providing additional clinical updates for bexobrutideg and remains on track to initiate pivotal trials for bexobrutideg in CLL in the second half of 2025. To support future development of bexobrutideg in autoimmune and inflammatory diseases, Nurix is enrolling a Phase 1b cohort for patients with CLL and autoimmune hemolytic anemia and is conducting the necessary Phase 1 healthy volunteer studies to support a potential autoimmune IND in 2026. More information on the ongoing Phase 1a/1b trial of bexobrutideg is available at www.clinicaltrials.gov (NCT05131022).

Zelebrudomide: Zelebrudomide is an orally bioavailable degrader of BTK and the cereblon neosubstrates IKZF1 (Ikaros) and IKZF3 (Aiolos) designed for the treatment of relapsed or refractory B-cell malignancies. Nurix is conducting a Phase 1a/1b clinical trial, including a Phase 1b expansion cohort focused on patients with diffuse large B-cell lymphoma and mantle cell lymphoma. Nurix is enrolling a dose escalation study within the current Phase 1a/1b trial using the chirally controlled drug product. Additional information on the zelebrudomide clinical trial can be accessed at www.clinicaltrials.gov (NCT04830137).

NX-1607: NX-1607 is an investigational oral inhibitor of the E3 ligase Casitas B-lineage lymphoma proto-oncogene B (CBL-B) being developed for immuno-oncology indications, including a range of solid tumor types and lymphomas. Nurix is evaluating NX-1607 in an ongoing Phase 1 trial in adults in a range of oncology indications. This study includes a thorough investigation of both dose and schedule in the Phase 1a portion. Additional information on the NX-1607 clinical trial can be accessed at www.clinicaltrials.gov (NCT05107674).

Continued pipeline advancement of strategic collaborations with Gilead, Sanofi and Pfizer: Nurix and Sanofi continue to advance the STAT6 degrader, NX-3911, in IND-enabling studies and future updates are anticipated. Nurix expects to continue to achieve substantial research collaboration milestones throughout the terms of its collaborations with Gilead, Sanofi, and Pfizer.

Nurix expects to provide additional preclinical, clinical, and program updates throughout 2025 to multiple key audiences, including the European Society for Medical Oncology, the Society for Immunotherapy of Cancer (SITC) (Free SITC Whitepaper) and the American Society of Hematology (ASH) (Free ASH Whitepaper).

*Expected timing of events throughout this press release is based on calendar year quarters.

Fiscal Third Quarter 2025 Financial Results

Revenue for the three months ended August 31, 2025, was $7.9 million, compared with $12.6 million for the three months ended August 31, 2024. Revenue from the collaboration with Sanofi decreased as the initial research term for certain drug targets ended. The decrease was offset by a higher percentage of completion of performance obligations in the current period related to the collaboration with Pfizer.

Research and development expenses for the three months ended August 31, 2025, were $86.1 million compared with $55.5 million for the three months ended August 31, 2024. The increase was primarily related to clinical, contract manufacturing and consulting costs as Nurix continued to accelerate the enrollment of patients in the ongoing trial of bexobrutideg and prepare for the initiation of pivotal trials.

General and administrative expenses for the three months ended August 31, 2025, were $13.2 million, compared with $11.7 million for the three months ended August 31, 2024. The increase was primarily due to an increase in compensation and related personnel costs.

Net loss for the three months ended August 31, 2025, was $86.4 million, or ($1.03) per share, compared with $49.0 million, or ($0.67) per share, for the three months ended August 31, 2024.

Cash, cash equivalents and marketable securities was $428.8 million as of August 31, 2025, compared to $609.6 million as of November 30, 2024.

Sapu Nano Unveils First-in-Human Clinical Trial of Sapu-003 at 8th Australian Translational Breast Cancer Research Symposium

On October 8, 2025 Sapu Nano reported the presentation of its poster, "Sapu-003: Novel Intravenous Deciparticle Everolimus Entering Phase 1 Study in Australia," at the 8th Australian Translational Breast Cancer Research Symposium (ATBCR 2025) (Press release, Sapu Bioscience, OCT 8, 2025, View Source [SID1234656520]). Sapu Nano is part of the Sapu family of companies, formed through GMP Biotechnology Limited, a joint venture between Oncotelic Therapeutics, Inc. (OTCQB: OTLC) and Dragon Overseas Capital Limited.

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Sapu-003 is the first intravenous (IV) Deciparticle formulation of everolimus, an mTOR inhibitor widely used in oncology. While oral everolimus (Afinitor) has demonstrated efficacy in breast cancer, renal cell carcinoma, and neuroendocrine tumors, its broader use has been constrained by low bioavailability, variable systemic exposure, and gastrointestinal toxicities.

Global Development Partnership
The trial is being conducted in collaboration with SOCRU, a leading Phase 1 clinical unit in Australia; Ingenū, a clinical research organization with deep early-phase expertise; and Medicilon, Sapu Nano’s strategic partner for preclinical drug development. Together, these partnerships ensure robust clinical execution, regulatory alignment, and high-quality product supply for the study.

Call to Patients and Physicians
The trial (ACTRN12625001083482) is now open for enrollment at leading oncology centers across Australia. Eligible participants include adults with advanced HR+/HER2- breast cancer or other mTOR-sensitive tumors who have exhausted standard therapies. Physicians are encouraged to refer patients who may benefit from participation.

"Sapu-003 represents a significant advance in the delivery of mTOR-targeted therapies," said Vuong Trieu, PhD, Chief Executive Officer of Sapu Nano. "Through the combined expertise of SOCRU, Ingenū, and Medicilon, we are positioned to accelerate development and bring this next-generation treatment option to patients with advanced cancers."

Oncoinvent Reports Positive Final Data from Phase 1 Trial of Radspherin® to Treat Ovarian Cancer

On October 8, 2025 Oncoinvent reported new data highlight continued potential of Radspherin to prevent disease progression Oncoinvent ASA, a clinical-stage radiopharmaceutical company developing innovative treatments for solid cancers, announced positive final 24-month follow-up results from its Phase 1 clinical trial (RAD-18-001) evaluating Radspherin in patients with platinum-sensitive recurrent ovarian cancer and peritoneal carcinomatosis (Press release, Oncoinvent, OCT 8, 2025, https://www.oncoinvent.com/press-release/oncoinvent-reports-positive-final-data-from-phase-1-trial-of-radspherin-to-treat-ovarian-cancer/?utm_source=mailpoet&utm_medium=email&utm_source_platform=mailpoet [SID1234656487]). Radspherin, direct intraperitoneal targeting with the alpha-emitter radium-224, aims to eliminate post-surgery micro-metastases and thereby prevent or delay peritoneal recurrence.

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In this Phase 1 trial, 10 out of 21 patients received the highest and recommended intraperitoneal dose of 7 MBq Radspherin after dose escalation (1, 2, 4 and 7 MBq). The final 24-month data still reports that only 1 of these 10 patients had peritoneal recurrence, and peritoneal recurrence rate remains at 10%. Two additional patients were reported with lymph node metastases outside of the peritoneum, giving an overall recurrence rate of 30%. In similar populations, approximately 55-60% of patients receiving best standard of care would expect disease recurrence at this time point[1],[2],[3].

"These highly encouraging results conclude our Phase 1 program for Radspherin and fuel our determination to advance Radspherin as an innovative treatment for patients with peritoneal metastases as quickly as possible," said Oystein Soug, CEO of Oncoinvent. "We are profoundly grateful to the patients, investigators, and the team for their invaluable contributions and look forward to interim results from our Phase 2 study next year."

"Peritoneal metastases remain a defining challenge in ovarian cancer, often driving recurrence," said Dr. Luis Chiva, Principal Investigator and Director of Department of Obstetrics and Gynecology, Clinica Universidad de Navarra, Spain. "These final results are truly encouraging, suggesting that Radspherin could help delay disease progression and offer patients hope for longer, healthier lives. It is particularly promising to see that the new recurrences were limited to lymph nodes, which are typically associated with longer survival compared to peritoneal relapses.

About RAD-18-001

RAD-18-001 was an open label Phase 1 trial conducted in patients with peritoneal metastases in platinum-sensitive recurrent ovarian cancer. The trial was designed to evaluate dosing, safety and tolerability, and signal of efficacy of intraperitoneally administered Radspherin following complete surgical resection. A total of 21 patients were enrolled across sites in Norway, Belgium and Spain.

Alligator announces publication of OPTIMIZE-1 biomarker analysis in Cell Reports Medicine supporting mitazalimab and mFOLFIRINOX in metastatic pancreatic cancer

On October 8, 2025 Alligator Bioscience (Nasdaq Stockholm: ATORX), a clinical-stage biotechnology company developing tumor-directed immuno-oncology antibody drugs, reported the publication of a peer-reviewed article in Cell Reports Medicine, a Cell Press journal (Press release, Alligator Bioscience, OCT 8, 2025, View Source [SID1234656505]). The paper presents biomarkers associated with clinical efficacy endpoints from the Phase 1b/2 OPTIMIZE-1 trial evaluating Alligator’s CD40 agonist mitazalimab in combination with mFOLFIRINOX chemotherapy in patients with untreated metastatic pancreatic ductal adenocarcinoma (mPDAC).

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The publication, titled "CD40 agonist mitazalimab with mFOLFIRINOX in untreated metastatic pancreatic cancer: biomarkers associated with outcomes from OPTIMIZE-1", provides mechanistic insights into determinants of clinical response and offers translational support for a planned randomized Phase 3 trial.

Key findings from the publication include:

Clinical efficacy: The OPTIMIZE-1 study met its primary endpoint, with a confirmed objective response rate of 42.1% in the Phase 2 cohort. Median duration of response was 12.6 months, progression-free survival 7.7 months, and overall survival 14.9 months. The survival rate at 24 months was 29.4%, triple that of chemotherapy alone.
Tumor gene signature linked to outcome: Baseline expression of a tumor-intrinsic fibrotic gene signature, directly linked to the mode of action of mitazalimab, was associated with improved overall survival.
Peripheral immune activation: Mitazalimab-induced increases in circulating activated immune cells correlated with better clinical outcomes.
Intratumoral immune activation: Patients with objective clinical responses displayed mitazalimab-induced immune activation supporting mitazalimab’s contribution to clinical outcomes
Translational impact: strongly supports mitazalimabs contribution to the improved clinical outcomes observed in OPTIMIZE-1 and supports future development of predictive biomarkers for mitazalimab.
"These data provide important guidance for understanding which patients may benefit most from mitazalimab-based immunotherapy in pancreatic cancer, and provides further evidence for mitazalimab’s contribution to the sustained clinical benefit observed in the OPTIMIZE-1 trial" said Søren Bregenholt, CEO of Alligator Bioscience. "The integration of biomarker-driven insights into our clinical development strategy strengthens the foundation for the next phase of mitazalimab’s evaluation in this high-need indication."

Aptevo Presenting Scientific and Clinical Updates at SITC and ASH, also Participating in Leading Financial and Industry Conferences in the Fourth Quarter

On October 8, 2025 Aptevo Therapeutics ("Aptevo" or the "Company") (Nasdaq:APVO), a clinical-stage biotechnology company developing novel bispecific and trispecific immuno-oncology therapeutics, reported its participation in upcoming key financial, industry, scientific and medical conferences this fall, providing the opportunity to highlight continued momentum and recent developments among a broad range of stakeholder audiences (Press release, Aptevo Therapeutics, OCT 8, 2025, View Source [SID1234656521]).

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These conferences include:

4th Annual ROTH Healthcare Opportunities Conference
October 9, 2025 – Metropolitan Club, New York City, New York

Aptevo will participate in a panel on Acute Myeloid Leukemia titled "Novel AML Therapies Showing Clear Clinical Progress," discussing progress and recent trial outcomes of its lead asset, mipletamig, and sharing emerging evidence of its differentiated clinical profile in frontline AML-where strong safety, tolerability, and early efficacy continue to demonstrate meaningful potential for improved patient outcomes

Biotechnology Innovation Organization (BIO)-Europe 2025 – 31st Annual International Partnering Conference
November 3-5, 2025 (in-person); Digital Partnering Days: November 11-12, 2025 – Messe Wien Exhibition & Congress Center, Vienna, Austria

The Business Development Team will be on-site and actively participating in meetings at the largest biotechnology meeting in Europe

Society of Immunotherapy in Cancer (SITC) (Free SITC Whitepaper) 2025 – 40th Anniversary Annual Meeting
November 5-9, 2025 – Gaylord National Resort & Convention Center, National Harbor, Maryland

Aptevo’s R&D Team will present a poster highlighting a novel trispecific targeting Nectin-4, CD3 and CD40 to overcome the immunosuppressive the tumor microenvironment

American Society of Hematology (ASH) (Free ASH Whitepaper) 2025 – 67th American Society of Hematology (ASH) (Free ASH Whitepaper) Annual Meeting & Exposition
December 6-9, 2025 – Orange County Convention Center, Orlando, Florida

Interim results from the ongoing Phase 1b/2 RAINIER trial evaluating mipletamig in frontline combination therapy for the treatment of AML, will be presented in a poster session by the clinical team.