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Corporate overview

On January 12, 2026 Olema Oncology presented its corporate presentation.

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(Presentation, Olema Oncology, JAN 12, 2026, View Source [SID1234661963])

Nurix Therapeutics Outlines 2026 Goals and Objectives for Advancing Bexobrutideg and Its Pipeline of Novel Degrader-Based Medicines in Cancer and Autoimmune Diseases

On January 12, 2026 Nurix Therapeutics, Inc. (Nasdaq: NRIX), a clinical-stage biopharmaceutical company focused on the discovery, development and commercialization of targeted protein degradation medicines in oncology and autoimmune diseases, reported the Company’s achievements in 2025 and outlined key objectives and anticipated milestones for 2026, which will be the subject of Nurix’s corporate update at the 44th Annual J.P. Morgan Healthcare Conference today at 4:30 p.m. PT, in San Francisco.

"2025 was a defining year for Nurix, having advanced our potentially best-in-class BTK degrader, bexobrutideg, into pivotal development for patients with relapsed or refractory CLL," said Arthur T. Sands, president and chief executive officer of Nurix. "As we enter 2026, we are focused on executing the DAYBreak CLL-201 study and initiating the confirmatory Phase 3 trial, DAYBreak CLL-306. We are also excited to advance our pipeline of wholly owned and partnered programs in inflammation and autoimmune diseases, including our new tablet formulation of bexobrutideg, our IRAK4 degrader program partnered with Gilead, and our STAT6 degrader program partnered with Sanofi. With our pivotal DAYBreak program underway, a strong balance sheet, and multiple catalysts across oncology and immunology, we believe Nurix is exceptionally well positioned to make 2026 a transformative year for the Company and the field of targeted protein degradation."

2025 Select Accomplishments and Business Highlights

Potential Best-in-Class BTK degrader, Bexobrutideg, in CLL

Presented new and updated clinical and preclinical data supporting a potential best-in-class BTK degrader profile. New and updated clinical data were presented in December 2025 at the 67th American Society of Hematology (ASH) (Free ASH Whitepaper) Annual Meeting (ASH2025) that provide a maturing clinical picture of bexobrutideg’s efficacy, durability, and tolerability. Highlights included an 83% objective response rate, including two complete responses (4.3%) in CLL patients with a median of four prior lines of treatment. Responses were durable and deepened over time with a median progression-free survival estimated at 22.1 months, which is highly competitive with currently approved agents in a similar line of therapy. Bexobrutideg was well tolerated with no dose-limiting toxicities across all doses tested. New preclinical data were presented in October 2025 that support bexobrutideg’s potential best-in-class BTK degrader profile, demonstrating superior degradation potency, broad coverage of clinically relevant BTK mutations, and exquisite selectivity. These findings strengthen the Company’s conviction that bexobrutideg may prove to be a clinically superior medicine for the treatment of patients with CLL and other B-cell driven diseases.

Successfully addressed FDA’s Project Optimus with the selection of the 600 mg once daily dose for pivotal development in r/r CLL. The selection of the 600 mg dose was supported by data from a randomized cohort within the Phase 1b study comparing 200 mg and 600 mg in accordance with Project Optimus and reflects alignment with global regulators, including the U.S. Food and Drug Administration, the UK Medicines and Healthcare products Regulatory Agency, and the European Medicines Agency. The results, subsequently reported at ASH (Free ASH Whitepaper)2025, demonstrated a trend toward a higher objective response rate and longer progression-free survival with the 600 mg dose without an increase in adverse events. The clearance by regulators of the 600 mg dose allows Nurix to optimize bexobrutideg’s therapeutic effect, providing patients the opportunity to regain control of CLL that has progressed or has failed to respond to other therapies.

Initiated pivotal clinical development in patients with relapsed or refractory CLL. In October 2025, Nurix initiated enrollment in the DAYBreak CLL-201 pivotal Phase 2 study (NCT07221500). This single-arm, global study is evaluating bexobrutideg at 600 mg once daily in patients with relapsed or refractory CLL whose disease progressed following treatment with a BTK inhibitor and a BCL2 inhibitor. The trial is designed to support accelerated approval of bexobrutideg in triple-exposed CLL/SLL patients. Nurix plans to initiate a randomized confirmatory Phase 3 trial in 2026 to support full approval of bexobrutideg.

First-in-class CBL-B Inhibitor NX-1607

Presented positive Phase 1a clinical data demonstrating immune activation and clinical activity. New Phase 1a clinical data for NX-1607 were presented at the European Society for Medical Oncology (ESMO) (Free ESMO Whitepaper) Congress in October and the 2025 Society for Immunotherapy of Cancer (SITC) (Free SITC Whitepaper) Annual Meeting in November, demonstrating dose-dependent pharmacologic activity and signals of clinical activity across a diverse set of 82 patients with eleven different tumor types. Clinical activity was observed through reductions in tumor-specific biomarkers such as prostate-specific antigen (PSA) in prostate cancer and carcinoembryonic antigen (CEA) in colorectal cancer. Notably, there was a confirmed partial response in a patient with micro-satellite stable colorectal cancer (MSS CRC), a tumor type typically unresponsive to immune checkpoint therapy. As anticipated, treatment with NX-1607 led to increased peripheral T cell activation and proliferation, indicating active T-cell receptor engagement and immune responsiveness, suggesting its potential as an active immune-oncology agent with a unique mechanism distinct from PD-1/PD-L1 therapies.

Advancing Pipeline in Inflammation and Autoimmune Diseases

Introduced new tablet formulation of bexobrutideg into Phase 1 testing to support an IND for inflammation and autoimmune indications. In 2025, Nurix initiated a Phase 1 single ascending and multiple ascending dose (SAD/MAD) study to evaluate pharmacokinetics (PK), pharmacodynamics (PD), and safety of a new tablet formulation of bexobrutideg. This study is intended to support an IND filing and enable expansion into inflammatory and autoimmune indications beginning in 2026.

Partner Gilead initiated Phase 1 testing of IRAK-4 degrader. In April 2025, Nurix announced that the FDA cleared the Investigational New Drug (IND) application for GS-6791 (previously NX-0479), a novel, potentially best-in-class oral degrader of IRAK4 being developed in collaboration with Gilead Sciences. GS-6791 is designed to selectively degrade IRAK4, a key signaling protein that drives inflammation in autoimmune and inflammatory diseases. Gilead subsequently initiated an ongoing Phase 1 trial in healthy volunteers, the results of which will inform Nurix’s option for a 50/50 co-development and U.S. profit share.

Partner Sanofi advanced STAT6 degrader program into IND enabling studies: In June 2025, Nurix announced that Sanofi exercised its option to extend its license for Nurix’s STAT6 program, including the development candidate NX-3911. NX-3911 is an oral, highly selective degrader of STAT6, a key transcription factor within the IL-4/IL-13 signaling pathways that drive inflammation in allergic and type 2 inflammatory conditions, which currently is in IND enabling studies. Sanofi is responsible for all development activities, and Nurix retains an option for a 50/50 U.S. profit share and co-promotion after initial clinical proof of concept.

Corporate and Leadership

Strengthened financial position to support execution of bexobrutideg pivotal program and expansion into inflammation and autoimmune disease. In October 2025, Nurix closed an underwritten registered offering of 24,485,799 shares of its common stock, providing gross proceeds to Nurix of $250.0 million, before deducting underwriting discounts and commissions and other offering expenses payable by Nurix. In addition, Nurix earned $47.0 million in non-dilutive capital through its strategic collaborations with Gilead, Sanofi and Pfizer. Nurix is well capitalized with pro forma cash/investments of $663.8 million1.

Strengthened leadership with appointments of chief commercial officer and new board members with deep experience in drug development and commercialization. In 2025, Nurix announced the hiring of John Northcott as chief commercial officer, bringing extensive U.S. and global commercial leadership experience, including both pre-launch planning and on-market commercialization in hematology, oncology and a wide range of other therapeutic areas. In addition Nurix also appointed two board members: Roy Baynes, MB.Bch., M.Med., Ph.D., who has extensive experience in the development of innovative, blockbuster medicines during a distinguished career in hematology and oncology, and Roger Dansey, M.D., senior leader in drug development and operations with over 25 years of executive experience in pharmaceutical and biotech companies across both U.S. and international markets.

2026 Outlook: Executing the Next Phase of Growth

Execute pivotal development pathway in CLL:
Enrollment of pivotal Phase 2 trial – DAYBreak CLL-201
Initiation of a confirmatory Phase 3 study in patients with r/r CLL in the 2L+ setting comparing bexobrutideg monotherapy to pirtobrutinib – DAYBreak CLL-306
Initiation of a Phase 1b/2 clinical study in patients with CLL in combination with other therapeutic agents including venetoclax (BCL-2 inhibitor)
Advance Degrader Programs in I&I:
Bexobrutideg – data from new tablet formulation SAD/MAD study supporting IND in I&I
GS-6791 IRAK4 degrader – potential Phase 1 results2
NX-3911 STAT6 degrader – potential IND filing by Sanofi2
Report Ongoing Clinical Data Updates:
Bexobrutideg Phase 1a/b CLL cohorts
Bexobrutideg Phase 1a/b NHL cohorts
Zelebrudomide Phase 1a cohorts
Progress Research and Development Pipeline:
Leverage DEL-AITM platform to fuel wholly owned and partnered drug discovery programs
Earn additional research milestones and potential licensing fees from its collaborations with Gilead, Sanofi, and Pfizer.

1Represents cash balance as of August 31, 2025, plus the net proceeds from the October 2025 registered direct offering

2Statements include Nurix estimate for partnered programs using industry standard timelines based on current stage of development (not official guidance of partners).

About Bexobrutideg (NX-5948)
Bexobrutideg is an investigational, orally bioavailable, brain penetrant, highly selective small molecule degrader of BTK currently being evaluated in the DAYBreak CLL-201 clinical trial (NCT07221500), a pivotal single-arm Phase 2 study of bexobrutideg in patients with relapsed or refractory chronic lymphocytic leukemia. Bexobrutideg also continues to be studied in the NX-5948-301 Phase 1a/1b clinical trial (NCT05131022) in patients with relapsed or refractory B cell malignancies.

About NX-1607
NX-1607 is an investigational first-in-class 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. CBL-B is a cytoplasmic E3 ubiquitin ligase that negatively regulates T cell activation, making it an attractive target for immuno-oncology and offering a novel therapeutic approach to treat solid tumors. Inhibition of CBL-B in preclinical studies reverses T cell exhaustion, alleviates tumor induced immunosuppression, and may also exert direct antitumor effects. 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).

(Press release, Nurix Therapeutics, JAN 12, 2026, View Source [SID1234661962])

Nerviano Medical Sciences announces NMPA Clearance of IND for PARP7-Selective Inhibitor Atamparib in Promising New Therapeutic Setting

On January 12, 2026 NMS Group (NMS), a global leader in oncological innovation, reported that the China’s National Medical Products Administration (NMPA) has granted approval to the Investigational New Drug (IND) application for its first-in-class, orally bioavailable PARP7-selective inhibitor, atamparib, enabling its clinical studies in patients with advanced solid tumors.

The phase Ib/II clinical trial expected to start in the first quarter of 2026 is designed to evaluate the safety, tolerability, pharmacokinetics, and preliminary antitumor activity of atamparib in patients with advanced solid tumors, with a focus on a promising new therapeutic sub-setting. The goal is to validate the molecule’s differentiated mechanism of action and its favorable safety and tolerability with more than 200 patients treated so far, both in late-line patients and in future combination with standard-of-care in earlier treatment settings.

"The IND approval in China represents a key strategic milestone for the development of atamparib," said Hugues Dolgos, CEO of NMS Srl. "Recent data generated across preclinical and clinical programs, along with the newly published mechanism of action, have enabled us to reposition this asset into a promising sizeable indication where we believe it can deliver meaningful clinical benefit."

"Conducting the study in China is expected to support atamparib global clinical development by enabling timely access to a clinically relevant patient population and facilitating the potential availability of new treatment options for patients in China and worldwide," said Dadong Li, CEO of NMS Shanghai. "This milestone marks an important step in advancing the development of atamparib and exploring its potential to expand treatment options for patients."

In parallel, NMS is advancing a dual inhibitor program currently in preclinical development, targeting PARP7 and another undisclosed target, which is expected to complement the clinical development strategy of atamparib and underscores the company’s commitment to building a differentiated portfolio of innovative therapeutic candidates.

(Press release, Nerviano Medical Sciences, JAN 12, 2026, View Source [SID1234661961])

Mereo BioPharma Provides Corporate Update

On January 12, 2026 Mereo BioPharma Group plc (NASDAQ: MREO) ("Mereo" or the "Company"), a clinical-stage biopharmaceutical company focused on rare diseases, reported an update on its programs, setrusumab for the treatment of osteogenesis imperfecta (OI) and alvelestat, which is being studied for the treatment of alpha-1 antitrypsin deficiency-associated lung disease (AATD-LD), and revised its cash runway guidance.

Data from the Phase 3 Orbit and Cosmic studies of setrusumab in osteogenesis imperfecta, including data on bone mineral density, vertebral fractures, and patient reported outcomes on pain and physical function, will be presented at the J.P. Morgan Healthcare Conference.

The Company is also updating its previous cash runway guidance. As of December 31, 2025, cash and cash equivalents were approximately $41 million, which are expected to fund operations to mid-2027.

"The reductions and delays in pre-commercial and manufacturing activities related to setrusumab that we implemented following the recent top-line data from the Phase 3 Orbit and Cosmic studies have extended our cash runway to mid-2027 and we will continue to tightly manage our resources as we assess potential next steps for the program, alongside our partner, Ultragenyx," said Dr. Denise Scots-Knight, Chief Executive Officer of Mereo. "There are no FDA or EMA approved treatments for people living with OI. Although bisphosphonates are used to improve bone mineral density, OI remains a high unmet need. We will continue to assess the totality of the Phase 3 trial data to determine next steps, including potential interactions with the regulators. In parallel, we are advancing partnering discussions for our Phase 3 ready program, alvelestat in AATD-LD."

Dr. Scots-Knight is scheduled to present at the 44th Annual J.P. Morgan Healthcare Conference on Wednesday, January 14, 2026 at 1:30pm PT (9:30pm GMT). A live audio webcast of the presentation can be accessed through the news and events section of the Company’s website at www.mereobiopharma.com/news. Following the conclusion of the live event, an archived replay will be available on the Company’s website.

Setrusumab (UX143)

As announced on December 29, 2025, the Phase 3 Orbit and Cosmic studies of setrusumab in OI did not achieve statistical significance against the primary endpoints of reduction in annualized clinical fracture rate compared to placebo or bisphosphonates, respectively. Both studies achieved strong statistical significance against the key secondary endpoint of improvement in bone mineral density versus comparator. The improvement in bone mineral density in the Cosmic study was associated with a decreased rate of fracture in this younger more highly fracturing patient population, although this was not statistically significant. The safety profile of setrusumab was consistent with that observed in prior studies.

Further analyses of the data from both studies are ongoing to determine the path forward, including potential regulatory interactions.

There is a high unmet medical need in OI, which is associated with a substantial clinical, humanistic and economic burden of illness due to the complexity of the condition and necessary medical care and support. As well as fractures, people living with OI present with a broad spectrum of skeletal features including bone deformity, scoliosis and growth impairment. Pain is the most common and impactful sign, symptom or clinical event reported in children and adolescents.

There are no EMA or FDA approved treatments for OI (except for neridronate, which is approved nationally in Italy). Bisphosphonates are used off-label in children in Europe and the U.S., despite the lack of clinical evidence to support their effectiveness in reducing fractures.

Alvelestat (MPH-966)

The Company is continuing to advance key activities to support the planned initiation of the global Phase 3 pivotal study. Based on previous discussions with the FDA and EMA, Mereo anticipates a single Phase 3 trial enrolling approximately 220 early- and late-stage AATD-LD patients evaluating alvelestat over an 18-month treatment period will support regulatory submissions in both the U.S. and Europe. The primary efficacy endpoint for U.S. approval will be the St. George’s Respiratory Questionnaire (SGRQ) Total Score, with lung density measured by CT scan serving as the primary endpoint for potential European regulatory approval.

Mereo continues to be in active discussions with potential partners for the Phase 3 development and commercialization of alvelestat.

Vantictumab (OMP18R5)

The Company out-licensed vantictumab for autosomal dominant osteopetrosis Type 2 (ADO2) to āshibio, Inc. whilst retaining European rights. āshibio, Inc. is responsible for funding the global program and following regulatory discussions, plans to initiate a Phase 2 study in 2H 2026. Vantictumab was previously investigated in Phase 1a/b oncology trials in around 100 patients with biomarker evidence of potential impact on osteoclast function and high bone turnover which led to fragility fractures in some patients. āshibio, Inc. reported promising pre-clinical data at ASBMR 2025 in ADO2 mouse model. Vantictumab significantly decreased areal bone mineral density and rescued the bone phenotype in the ADO2 mouse model.

(Press release, Mereo BioPharma, JAN 12, 2026, View Source [SID1234661958])

New Data Underscoring Ability of Leapfrog Bio’s OncoSLX Platform to Identify Drug Retargeting Opportunities for Treating Cancer Published in Nature Portfolio Journal

On January 12, 2026 Leapfrog Bio, a clinical-stage precision oncology company dedicated to discovering and developing novel targeted therapies for cancers caused by loss-of-function (LOF) mutations, reported the publication of a peer‑reviewed study in npj Systems Biology and Applications, a Nature Portfolio journal, titled "Challenges and opportunities for oncology drug repurposing informed by synthetic lethality." The paper provides a practical framework for drug retargeting in oncology and highlights core discoveries that helped guide the optimization of Leapfrog Bio’s OncoSLX Platform.

"This paper validates two fundamental realities in targeted cancer drug discovery: genetic targeting opportunities discovered in cell lines are more likely to hold up in the clinic when caused by a driver mutation, and drugs behave very differently from genetic knockouts, so screening them against the causal biology is essential," said Tomas Babak, Ph.D., Founder and Chief Scientific Officer of Leapfrog Bio and co-author on the publication. "Our OncoSLX platform is built on these principles and allows us to run thousands of these drug-mutation tests against all cancer driver mutations simultaneously, quickly identifying potent, genetically targeted treatments for LOF cancers."

Dr. Babak continued, "By screening clinically safe drugs, we can restart development in Phase 2 in genetically selected patients where the probability of efficacy is higher. We expect this approach to be significantly accelerating and derisking as we advance through development."

"Leapfrog Bio was founded to bring the transformative benefit of precision medicines to the many patients with cancers caused by LOF mutations, for whom targeted options are limited," said Greg Vontz, Chief Executive Officer of Leapfrog Bio. "Among our most promising discoveries to date is the vulnerability of EP300 LOF cancers to BET inhibitors, like our lead candidate, LFB190. Leveraging learnings from our OncoSLX platform, we are positioned to advance LFB190 directly into mid-stage development. We look forward to initiating our planned Phase 1b/2a trial in mid-2026."

LFB190 is an oral, small-molecule, potentially best-in-class BETi in development for the more than 60,000 U.S. patients annually who are diagnosed with EP300-mutated solid tumors, including non-small cell lung, bladder, colon, pancreatic, head and neck, and bile duct cancers. While BET inhibitors have been widely studied across cancer indications, they have shown limited efficacy in genetically unselected populations. Extensive preclinical studies have shown that BET inhibitors can be highly effective when used to treat EP300-driven cancers, and previous clinical development of LFB190 as an untargeted therapy has shown favorable safety and tolerability for the drug.

About OncoSLX Platform
OncoSLX Platform is Leapfrog Bio’s proprietary pharmacogenetic platform that screens clinically characterized small molecules against isogenic models of cancer driver mutations, focusing on loss‑of‑function biology. Unlike traditional synthetic‑lethality approaches based on gene knockouts, OncoSLX captures the full spectrum of drug biology and then integrates real‑world outcomes data to prioritize indications likely to deliver survival benefit, compressing timelines and reducing translational risk. This approach identifies novel treatments for loss-of-function-driven cancers that cannot be discovered by conventional methods.

About LFB190 and EP300-Mutated Cancers
LFB190 is a novel, oral BET inhibitor for the treatment of solid tumors driven by EP300 loss-of-function (LOF) mutations. Leapfrog Bio’s OncoSLX Platform has identified a novel synthetic lethality relationship between BET inhibitors and EP300 LOF mutations, which are a known and frequent cancer driver with no targeted therapy available. LFB190 has shown strong preclinical efficacy in patient-derived xenograft (PDX) models of EP300-mutated cancers. EP300 is a tumor suppressor gene involved in chromatin remodeling and transcriptional regulation. When mutated, its loss contributes to tumor progression across multiple cancer types, including approximately 6 percent of non-small cell lung cancers (NSCLC), approximately 15 percent of bladder cancers, and similar frequencies in colon, pancreatic, and head and neck cancers. While BET inhibitors have historically shown limited efficacy in unselected populations, Leapfrog Bio’s platform revealed a compelling effect in EP300-mutated tumors.

(Press release, Leapfrog Bio, JAN 12, 2026, View Source [SID1234661957])