Anixa Biosciences (NasdaqCM:ANIX) Fireside chat Transcript

Summary of Anixa Biosciences Fireside Chat Company Overview - Company: Anixa Biosciences (NasdaqCM: ANIX) - Industry: Biotechnology - Focus: Development of CAR T cell therapy for ovarian cancer and a breast cancer vaccine - Clinical Stage: Engaged in clinical trials for cancer therapies Key Achievements in 2025 - Phase 1 Breast Cancer Vaccine Trial: Completed in collaboration with Cleveland Clinic and U.S. Department of Defense, with data presented in December 2025 [5][6] - CAR T Therapy Progress: Significant patient outcomes reported, with advancements in clinical trials and patent approvals [5][6] - Official Naming: CAR T therapy received official name approval from domestic and international organizations [6] Upcoming Milestones - Transition to Phase 2 for Breast Cancer Vaccine: Requires FDA report submission and discussions, with plans to enroll 80-100 women [7][10] - Manufacturing Plans: Working with manufacturers to produce larger vaccine quantities under GLP and GMP conditions [7][8] Financial Overview - Cash Burn: $7 million in the last fiscal year, with an expected increase to approximately $8 million for the upcoming year [11][12] - Cash Reserves: $15 million cash balance with no debt, providing over two years of operational runway [12][13] CAR T Therapy Developments - Safety and Efficacy: Phase 1 trial focused on safety, with promising early efficacy indicators; patients have outlived expected life expectancy [16][18] - Patient Outcomes: Some patients lived significantly longer than the median survival of 12 weeks, with one patient living 28 months [18][19] - Regulatory Approval: Seeking IRB approval to escalate dosages due to positive safety profile [19] Mechanisms of Action - Unique Targeting: CAR T therapy targets a unique protein present only on cancer cells, minimizing effects on healthy tissues [22] - Anti-Angiogenesis Effect: Potential destruction of tumor vasculature, enhancing treatment efficacy [23] - Peritoneal Delivery: Direct delivery to the peritoneal cavity improves therapy effectiveness and reduces systemic side effects [24] Lymphodepletion Strategy - Introduction of Lymphodepletion: Planned to enhance CAR T cell engraftment and proliferation, with careful monitoring of associated risks [31][33] - Comparative Analysis: Some cohorts will receive lymphodepletion while others will not, to evaluate its impact on patient outcomes [33] Expectations for 2026 - Pivotal Year: Anticipation of significant data from CAR T trials and breast cancer vaccine Phase 2 initiation [36][38] - Control Arm in Phase 2: Designed to evaluate the vaccine's efficacy against a control group [38] - Fiscal Responsibility: Commitment to maintaining financial prudence while advancing clinical trials [39] Conclusion - Outlook: 2026 is expected to be a busy and eventful year for Anixa, with critical data releases and potential partnerships on the horizon [39][40]