Summary of Vir Biotechnology FY Conference Call Company Overview - **Company**: Vir Biotechnology (NasdaqGS:VIR) - **Industry**: Biotechnology, focusing on infectious diseases and oncology - **Mission**: Harnessing the human immune system to combat diseases, including infectious diseases and cancer [2][3] Core Strategies and Pillars 1. **Hepatitis Delta Program**: - Aiming to deliver a transformational therapy for chronic hepatitis Delta, with a significant commercial opportunity in the U.S. and other regions [3][4] - Registration program for Hepatitis Delta is underway, with potential regulatory review expected in 2027 [4][16] - Estimated 174,000 viremic patients in key markets, with a global prevalence of about 7 million [6][9] 2. **T-cell Engagers for Oncology**: - Developing a clinical-stage lineup of dual-masked T-cell engagers targeting solid tumors, addressing high unmet needs [4][18] - Upcoming data on VIR-5500, a PSMA-targeting T-cell engager, expected in Q1 2026 [4][22] 3. **Discovery Engine**: - Focused on developing a pipeline of best-in-class preclinical T-cell engagers and cancer immunotherapies [5][30] - Utilizes a unique ProXTEN masking technology to enhance safety and efficacy of T-cell engagers [18][20] Key Data and Results - **Hepatitis Delta**: - Combination therapy of Tobevibart (monoclonal antibody) and elebsiran (siRNA) shows promising results, with 88% of patients achieving undetectable HDV RNA at 96 weeks [12][14] - Combination therapy demonstrated significant reductions in HBV surface antigen levels, critical for controlling the delta virus [13][15] - **Oncology**: - VIR-5500 has shown favorable efficacy and safety profiles in early trials, with low rates of cytokine release syndrome [22][25] - VIR-5818 (HER2-targeted) and VIR-5525 (EGFR-targeted) are also in development, with promising early efficacy signals [23][24] Financial and Strategic Partnerships - Entered a commercial license agreement with Norgine, including an upfront payment of EUR 550 million and milestone payments, which will help fund the Eclipse program [16][17] - Retained commercialization rights in the U.S. and other markets outside Greater China, indicating a strategic focus on growth in these regions [17] Future Milestones - Anticipated top-line data for the Eclipse studies in Q4 2026 and Q1 2027, with plans for rapid marketing authorization submission [31][32] - Continued focus on advancing the T-cell engager pipeline, with updates expected in early 2026 [32][33] Challenges and Considerations - Manufacturing scaling remains a focus, with expertise inherited from previous assets aiding in this process [39][40] - The company is not currently seeking additional opportunities in hepatitis B, focusing instead on existing programs [38] Conclusion Vir Biotechnology is positioned to make significant advancements in the treatment of hepatitis Delta and various cancers through its innovative therapies and strategic partnerships, with a strong pipeline and upcoming data expected to drive future growth and value creation [33]

Core Insights - The combination of pelareorep and atezolizumab has shown a nearly tripled objective response rate (ORR) compared to historical benchmarks, achieving an ORR of approximately 29% in a heavily pretreated population of third-line metastatic squamous cell anal carcinoma (SCAC) patients [1][3][5] - The median duration of response (DOR) for this combination therapy is approximately 17 months, indicating significant clinical benefit in a setting with no FDA-approved therapies [1][3][5] Clinical Data Summary - In the updated GOBLET Cohort 4, four out of 14 evaluable patients achieved objective responses, including two complete responses and two partial responses [3][4] - Historical studies in third-line SCAC typically report an ORR of around 10% or less, highlighting the potential of pelareorep plus atezolizumab in addressing unmet medical needs [4][5] Development Strategy - Oncolytics plans to pursue a registration study based on the promising data from GOBLET Cohort 4, aiming for accelerated approval from the FDA [7] - The company has received initial positive feedback from key opinion leaders (KOLs) and the FDA, with a Type C meeting scheduled for Q1 2026 to discuss the development plan [7]

Core Insights - OS Therapies Inc. is positioned to enhance the standard of care for metastatic osteosarcoma with its lead candidate OST-HER2, with significant regulatory submissions planned for 2026 [3][4][5] Regulatory Submissions - The company plans to submit a Biologics License Application (BLA) to the U.S. FDA by the end of January 2026 under the Accelerated Approval Program [4] - Marketing Authorization Applications (MAA) for conditional approval are expected to be submitted to the U.K. MHRA and the European EMA by the end of February 2026 and March 2026, respectively [4][5] Clinical Data and Milestones - Phase 2b biomarker data from the Metastatic Osteosarcoma Program is anticipated to be released during the week of the J.P. Morgan Healthcare Conference in January 2026 [2][12] - The company expects to engage in multiple meetings with regulatory authorities in the first half of 2026 to discuss clinical efficacy endpoints and trial designs [5] Designations and Incentives - OST-HER2 has received Orphan Disease Designation (ODD), Fast Track Designation, and Rare Pediatric Disease Designation (RPDD) from the FDA, making it eligible for a Priority Review Voucher (PRV) if approved before September 30, 2026 [6][9] Future Developments - The company is advancing its OS Animal Health subsidiary towards a go-public transaction, with a confidential SEC filing expected in early January 2026 [7][12] - Additional oncology programs, including OST-503 and OST-504, are also in development, with key meetings with the FDA planned for 2026 [8][12]

Core Insights - Anixa Biosciences has completed the transfer of the Investigational New Drug application for its breast cancer vaccine from Cleveland Clinic, becoming the trial sponsor for its future development [1][2] - The company plans to advance the vaccine into a Phase 2 clinical trial after completing enrollment and observing encouraging immune response and safety data in the Phase 1 trial [2][4] - The breast cancer vaccine targets -lactalbumin, a protein that re-emerges in many forms of breast cancer, potentially offering therapeutic and preventive benefits [3] Company Overview - Anixa is a clinical-stage biotechnology company focused on cancer treatment and prevention, with a portfolio that includes an ovarian cancer immunotherapy program developed in collaboration with Moffitt Cancer Center [5] - The company’s vaccine portfolio includes vaccines for breast and ovarian cancer, developed in collaboration with Cleveland Clinic, and aims to address various cancers by immunizing against "retired" proteins expressed in certain cancer forms [5] - Anixa's business model involves partnering with renowned research institutions to explore emerging technologies for further development and commercialization [5]

Core Insights - TuHURA Biosciences, Inc. has achieved a milestone in its clinical trial for REM-001, demonstrating safety and signs of clinical efficacy in ten metastatic cutaneous breast cancer patients after eight weeks of follow-up [1][2] Group 1: Company Overview - TuHURA Biosciences, Inc. is a Phase 3 immuno-oncology company focused on developing novel therapeutics to address resistance to cancer immunotherapy, a significant challenge in cancer treatment [3] - The company's lead product, IFx-2.0, aims to overcome primary resistance to checkpoint inhibitors and is currently in a Phase 3 trial as an adjunctive therapy to Keytruda® for advanced or metastatic Merkel Cell Carcinoma [4] Group 2: Recent Developments - Following the successful completion of the REM-001 trial, TuHURA will release an aggregate of 1,539,958 shares of common stock to legacy Kintara Therapeutics stockholders as per the Contingent Value Rights Agreement [2] - TuHURA has also acquired TBS-2025 through its merger with Kineta Inc., which is moving into Phase 2 development for mutNPM1 r/r AML [5]

Core Insights - Anixa Biosciences, Inc. announced positive final data from its Phase 1 clinical trial of an investigational breast cancer vaccine, indicating safety and immune response efficacy, supporting advancement to Phase 2 development [1][2][12] Group 1: Clinical Trial Results - The Phase 1 trial met all major primary endpoints, demonstrating safety and tolerability at the maximum tolerated dose (MTD), with 74% of participants showing protocol-defined immune responses [2][8] - The investigational vaccine, targeting alpha-lactalbumin (aLA), was well tolerated with minimal adverse effects, primarily injection-site irritation [6][9] - Participants will be followed for five years post-study to assess long-term outcomes [8] Group 2: Cohort Details - The trial included 35 participants across three cohorts, focusing on women at elevated risk of recurrence, those with BRCA mutations, and women receiving pembrolizumab (Keytruda) [5][10] - In Cohort Ia, the vaccine was safe with no flu-like symptoms reported, while Cohort Ib showed similar safety profiles [6][7] - Cohort Ic aimed to evaluate the combination of the vaccine with pembrolizumab, reporting no major adverse side effects [9] Group 3: Future Development Plans - The results support plans for a Phase 2 neoadjuvant combination study with Keytruda in newly diagnosed breast cancer patients [1][8] - Ongoing analyses of immunohistochemistry in resected breast tissue will provide further insights into the vaccine's efficacy [7][8] - The company aims to engage with regulators to advance the vaccine's development following the promising Phase 1 results [12]

Core Viewpoint - OS Therapies has successfully completed a pre-Marketing Authorisation Application meeting with the UK MHRA for its Phase 2b clinical trial of OST-HER2, aimed at preventing or delaying recurrent pulmonary metastatic osteosarcoma [2][4] Group 1: Clinical Trial and Regulatory Progress - The company achieved full alignment on key points regarding non-clinical, chemistry, manufacturing, and controls (CMC), and post-market authorization confirmatory study design during the pre-MAA meeting [6] - The company plans to submit a conditional MAA for the Metastatic Osteosarcoma Program to the MHRA by the end of January 2026 [4][6] - A meeting with the US FDA is scheduled for December 11, 2025, to discuss biomarker data analysis, which is crucial for supporting a Biologics Licensing Application under the Accelerated Approval Program [3][6] Group 2: Clinical Efficacy and Future Plans - The Phase 2b clinical trial of OST-HER2 demonstrated statistically significant benefits in the 12-month event-free survival primary endpoint [7] - The company anticipates submitting a Biologics Licensing Application to the US FDA for OST-HER2 in osteosarcoma in the first quarter of 2026, which could lead to eligibility for a Priority Review Voucher [7] - OST-HER2 has received various designations from the US FDA, including Rare Pediatric Disease Designation and Fast-Track designation, indicating its potential significance in treating osteosarcoma [5][7] Group 3: Product Development and Innovation - OS Therapies is advancing its next-generation Antibody Drug Conjugate (ADC) and Drug Conjugates (DC), known as tunable ADC (tADC), utilizing proprietary technology for enhanced delivery of therapeutic payloads [8]

Core Insights - OS Therapies has received a waiver from the U.S. FDA for the application fee related to BLA 125867 for its lead product OST-HER2, which is a listeria-based cancer immunotherapy [1][6] - The European Medicines Agency (EMA) has granted eligibility for Union Marketing Authorisation for OST-HER2 in the prevention or delay of recurrent, fully-resected pulmonary metastatic osteosarcoma, with a request for an accelerated Marketing Authorisation Application by February 28, 2026 [2] - The company is preparing for pre-Marketing Authorisation Application meetings with the UK's Medicines and Healthcare products Regulatory Agency (MHRA) and the U.S. FDA to discuss final commercial considerations and study designs [3][6] Company Overview - OS Therapies is a clinical-stage oncology company focused on developing treatments for osteosarcoma and other solid tumors, leading in listeria-based cancer immunotherapies [4] - OST-HER2 has received multiple designations from regulatory bodies, including Rare Pediatric Disease Designation and Fast-Track and Orphan Drug designations from the U.S. FDA and EMA [4] - The company reported positive results from its Phase 2b clinical trial of OST-HER2, showing statistically significant benefits in the 12-month event-free survival primary endpoint [4] Future Developments - The company anticipates submitting a Biologics Licensing Application (BLA) for OST-HER2 in early 2026, which could lead to eligibility for a Priority Review Voucher [4] - OS Therapies is also advancing its next-generation Antibody Drug Conjugate (ADC) and Drug Conjugates (DC), known as tunable ADC (tADC), utilizing proprietary technology for enhanced delivery [5][7]

Core Viewpoint - OS Therapies has received approval from the World Health Organization for the non-proprietary name 'daznelimgene lisbac' for its cancer immunotherapy product candidate OST-HER2, which is aimed at treating pulmonary metastatic osteosarcoma [1][2][3]. Company Overview - OS Therapies is a clinical stage oncology company specializing in listeria-based cancer immunotherapies, particularly for osteosarcoma and other solid tumors [3]. - The company is recognized as a leader in listeria-based cancer immunotherapies and is developing OST-HER2 to leverage the immune-stimulatory effects of Listeria bacteria [3]. Product Development - OST-HER2 has received multiple designations from regulatory authorities, including Rare Pediatric Disease Designation (RPDD) from the U.S. FDA and Fast-Track and Orphan Drug designations from both the U.S. FDA and European Medicines Agency [3]. - The company reported positive results from its Phase 2b clinical trial of OST-HER2, showing statistically significant benefits in the 12-month event-free survival (EFS) primary endpoint [3]. - A Biologics Licensing Application (BLA) for OST-HER2 is anticipated to be submitted to the U.S. FDA in early 2026, with the potential to receive a Priority Review Voucher if approved [3]. Future Plans - OS Therapies is on track to receive regulatory feedback from U.S., UK, and European authorities in December 2025, with plans to file for regulatory approvals starting in January 2026 [3]. - The company is also advancing its next-generation Antibody Drug Conjugate (ADC) and Drug Conjugates (DC) platform, known as tunable ADC (tADC), which utilizes proprietary technology for enhanced delivery of therapeutic payloads [4].

Core Viewpoint - Anaptysbio and GSK are engaged in a legal dispute over alleged breaches of contract related to the marketing of the cancer immunotherapy Jemperli, with both companies filing lawsuits against each other [1][2]. Group 1: Legal Dispute - Anaptysbio claims GSK violated their decade-old agreement by testing its experimental cancer drugs alongside competitors of Jemperli, such as Merck's Keytruda [2]. - GSK initiated the lawsuit first, asserting that Anaptysbio's actions constituted a material breach of the license agreement, seeking to terminate the agreement and reduce royalties owed to Anaptysbio [4]. - Anaptysbio's countersuit alleges that GSK's testing of other PD-1 drugs before Jemperli breached the terms of their license [4]. Group 2: Background of the Agreement - The lawsuits stem from a 2014 deal between Anaptysbio and Tesaro, which licensed Jemperli, a PD-1 inhibitor similar to Keytruda and Opdivo [3]. - GSK acquired Tesaro in 2019 for $5.1 billion, primarily for the ovarian cancer drug Zejula, but also recognized the potential of Jemperli [3]. Group 3: Financial Implications - Jemperli generated sales of approximately $785 million through the first nine months of 2025, with projections to reach $1 billion by year-end [6]. - Anaptysbio stands to receive a $75 million milestone payment and royalties of 8% on sales up to $1 billion, increasing to 12% on sales between $1 billion and $1.5 billion [6].