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]

Core Insights - Anixa Biosciences is reporting promising outcomes from its ongoing Phase 1 clinical trial of CAR-T therapy for recurrent ovarian cancer, with several patients exceeding expected survival rates at low dose levels [1][2][3] Group 1: Trial Overview - The Phase 1 trial is focused on adult women with recurrent ovarian cancer who have not responded to standard chemotherapy and have progressed after two or more therapies [2] - Twelve patients have been treated at four dosage levels, with seven patients living beyond the expected median survival of three to four months [2] - Notably, one patient survived 28 months post-treatment, and three others have survived over one year [2] Group 2: Safety and Efficacy - The trial primarily aims to demonstrate safety, and the absence of dose-limiting toxicities (DLTs) has allowed for significant dose escalation [3][5] - The dosing may increase from 1×10 to as high as 1×10 CAR-positive cells per kilogram, representing a two-order-of-magnitude increase [3] - The favorable safety profile is attributed to the intra-peritoneal delivery method, which may enhance localized tumor targeting while reducing systemic toxicity [3] Group 3: Future Directions - The next patient cohort will receive higher doses following a lymphodepletion regimen, which is expected to create a more favorable environment for CAR-T cell activity [4] - The regulatory approval for the protocol amendment allows for further evaluation of both safety and potential therapeutic benefits as the study progresses [5] - Anixa plans to discuss trial observations and future plans in an upcoming fireside chat on February 10, 2026 [1][6] Group 4: Technology and Collaboration - Anixa's CAR-T therapy, lira-cel, targets the follicle-stimulating hormone receptor (FSHR), which is selectively expressed on ovarian cells and certain cancer cells [7] - The company collaborates with Moffitt Cancer Center, a leader in cancer immunotherapy, to develop its CAR-T therapy and other cancer vaccines [8]

Core Insights - Anixa Biosciences, Inc. has provided an update on its Phase 1 ovarian cancer CAR-T clinical trial, highlighting positive patient outcomes following a protocol amendment that allows for significant dose escalation [1] Trial Overview - The trial involves liraltagene autoleucel (lira-cel), which targets the follicle-stimulating hormone receptor (FSHR) selectively expressed on ovarian cells and certain cancer cells, while sparing healthy tissue [2] - The ongoing Phase 1 trial is enrolling adult women with recurrent ovarian cancer who have not responded to standard chemotherapy and have progressed after two or more prior therapies [2] Patient Outcomes - Twelve patients have been treated at four dosage levels, with seven patients surviving beyond the expected median survival of approximately three to four months [3] - Notably, one patient survived 28 months post-treatment, while three others survived over one year (17, 15, and 14 months respectively) [4] Safety Profile - No dose-limiting toxicities (DLTs) have been observed, leading to the approval of a protocol amendment for significant dose escalation [5] - The favorable safety profile is believed to be partly due to the direct intra-peritoneal delivery of CAR-T cells, which may reduce systemic toxicity and enhance localized tumor targeting [6] Protocol Amendment - The amended protocol allows dosing to increase from 1×10⁵ to 1×10⁹ CAR-positive cells per kilogram of body weight, representing a two-order-of-magnitude increase [7] - The next patient cohort will receive 1×10⁷ cells/kg following a lymphodepletion regimen with cyclophosphamide and fludarabine [7] Lymphodepletion - Lymphodepletion is intended to reduce competing immune cells, creating a more favorable environment for CAR-T expansion and activity, although its role in solid tumors remains investigational [8] Market Reaction - Anixa Biosciences shares increased by 1.69% to $3.01 during premarket trading [8]

Core Viewpoint - Anixa Biosciences has received approval for the non-proprietary name "liraltagene autoleucel" for its CAR-T therapy targeting recurrent ovarian cancer, marking a significant step towards its commercialization [1][2]. Group 1: Company Developments - The USAN Council approved the non-proprietary name for Anixa's CAR-T therapy, which follows prior approval from the WHO's INN Expert Committee, allowing for a globally recognized drug name [1][2]. - The company is focused on executing its ongoing Phase 1 trial of liraltagene autoleucel, in partnership with Moffitt Cancer Center, aimed at treating ovarian cancer [2][3]. - Liraltagene autoleucel is a novel CAR-T therapy that targets the follicle stimulating hormone receptor (FSHR), which is expressed on normal ovarian cells and certain cancer cells [3]. Group 2: Technology and Research - The CAR-T technology, known as chimeric endocrine receptor-T cell (CER-T) therapy, utilizes a natural ligand to bind to the FSHR receptor on tumor cells, differentiating it from traditional cell therapies [3]. - The ongoing Phase 1 trial is designed to evaluate safety, identify the maximum tolerated dose, and monitor clinical activity in adult women with recurrent ovarian cancer who have progressed after at least two prior therapies [3]. Group 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 [4]. - The company also has a vaccine portfolio aimed at treating and preventing breast and ovarian cancer, developed in collaboration with Cleveland Clinic, which is entitled to royalties from these technologies [4]. - Anixa's business model involves partnerships with leading research institutions to explore and commercialize emerging technologies in cancer treatment [4].

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Revenue and Income - Revenue for fiscal years 2025 and 2024 was $0, with past revenue derived from technology licensing and patent sales [172]. - Interest income decreased to approximately $673,000 in fiscal year 2025 compared to approximately $1,133,000 in fiscal year 2024 [177]. Expenses - Research and development expenses decreased by approximately $1,325,000 to approximately $5,071,000 in fiscal year 2025 from approximately $6,396,000 in fiscal year 2024 [175]. - Research and development expenses for cancer vaccines and CAR-T therapeutics in fiscal year 2025 were approximately $3,121,000 and $1,950,000, respectively [174]. - General and administrative expenses decreased by approximately $805,000 to approximately $6,630,000 in fiscal year 2025 from approximately $7,435,000 in fiscal year 2024 [176]. Cash Flow and Financial Position - Cash used in operating activities was approximately $7,173,000 during the fiscal year ended October 31, 2025 [181]. - Cash, cash equivalents, and short-term investments decreased approximately $4,750,000 to approximately $15,174,000 at October 31, 2025 [181]. - The company raised approximately $2,378,000 net of expenses through an at-the-market equity offering of 772,001 shares of common stock during the fiscal year [180]. - Expected future cash obligations related to office leases through 2029 are estimated at approximately $256,000 [182]. Net Loss and Market Risk - The net loss attributable to noncontrolling interest decreased by approximately $43,000 to approximately $101,000 in fiscal year 2025 [178]. - No quantitative and qualitative disclosures about market risk were required for the smaller reporting company [197].

Summary of Anixa Biosciences Conference Call Company Overview - **Company**: Anixa Biosciences (NasdaqCM: ANIX) - **Industry**: Biotechnology - **Focus**: Clinical stage biotech company with two early-stage clinical developments: a CAR T cell therapy for ovarian cancer and a breast cancer vaccine program [1][2] Key Points and Arguments Breast Cancer Vaccine Program - The breast cancer vaccine program is designed as both a treatment and prophylactic, focusing on a novel approach targeting a protein expressed only during lactation, which is produced by cancer cells in some breast cancer patients [6][7][8] - The phase one study presented at the 2025 San Antonio Breast Cancer Symposium showed promising results, with the data exceeding expectations and being superior to other cancer vaccines in phase one trials [9][10] Phase One Study Results - The phase one trial involved three cohorts of women: 1. Women with a history of triple-negative breast cancer at high risk of recurrence 2. Women with BRCA mutations who opted for prophylactic mastectomies 3. Women with residual disease post-treatment [10][12][13] - Key findings: - The vaccine was found to be safe with no significant side effects, only mild injection site irritation [11][18] - Strong immune responses were observed in 75% of participants [11][20] - No significant differences in immune response rates among the cohorts [21] Future Clinical Trials - Plans for a phase two study in a neoadjuvant setting, where newly diagnosed breast cancer patients will receive the vaccine alongside standard care (Keytruda) [24][25] - The trial is expected to enroll 80 to 100 women and take approximately two to three years to complete, with data available much sooner [29][31] - The goal is to demonstrate the vaccine's efficacy in reducing tumor burden before surgery, potentially leading to better outcomes and lower recurrence rates [25][27] Corporate Strategy and Partnerships - Anixa aims to establish pharmaceutical partnerships to fund further trials and commercialize the vaccine, reducing reliance on capital markets [28] - The IND has been transferred from Cleveland Clinic to Anixa, allowing the company to sponsor the trial [32] Broader Research Initiatives - Anixa is also advancing preclinical and R&D vaccine programs targeting other cancers, including ovarian, prostate, lung, and colon cancers, with a focus on identifying unique proteins associated with these cancers [34][35] Additional Important Insights - The approach of targeting unique proteins on cancer cells aims to avoid autoimmune responses, which is a significant advantage over traditional cancer vaccine strategies [7][35] - The company is optimistic about the potential for the breast cancer vaccine findings to be replicated in other cancer types, indicating a broader application of their research strategy [34][35]

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 Viewpoint - Anixa Biosciences Inc. shares experienced a significant increase of 15.21% in after-hours trading following the presentation of final Phase 1 clinical trial data for its investigational breast cancer vaccine [1]. Phase 1 Trial Results - The final data was presented at the 2025 San Antonio Breast Cancer Symposium, showing that the vaccine met all major primary endpoints [2]. - The trial, conducted with the Cleveland Clinic and funded by a U.S. Department of Defense grant, demonstrated that protocol-defined immune responses occurred in 74% of participants [2][3]. - The investigational α-lactalbumin vaccine was reported to be safe and well-tolerated at the maximum tolerated dose [3]. Trial Details - The trial enrolled a total of 35 participants across three cohorts [4]. Next Steps - Anixa Biosciences plans to use the trial data to inform the design of a Phase 2 study, which may include a combination trial with Keytruda for newly diagnosed breast cancer patients [5]. - The Chairman and CEO of Anixa Biosciences expressed anticipation for engaging with regulators to advance plans for the Phase 2 study [5]. Trading Metrics - Anixa Biosciences has a market capitalization of $158 million, with a 52-week stock price range of $2.07 to $5.46 [6]. - Year-to-date, the stock has gained 106.90%, although it closed at $4.80, down 6.43% on Thursday [5][6].

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]