SAN JOSE, Calif., Feb. 2, 2026 /PRNewswire/ -- Anixa Biosciences, Inc. ("Anixa" or the "Company") (NASDAQ: ANIX), a biotechnology company focused on the treatment and prevention of cancer, today announced that the United States Adopted Names (USAN) Council approved "liraltagene autoleucel" for the non-proprietary name of the Company's novel FSHR-targeted CAR-T therapy for recurrent ovarian cancer. This U.S. approval follows the earlier approval for international use of the name by the International Nonprop ...

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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]

Core Insights - Anixa Biosciences, Inc. is participating in the Water Tower Research Fireside Chat Series on December 15, 2025, with CEO Dr. Amit Kumar as a speaker [1][2] - The company focuses on cancer treatment and prevention, with a notable emphasis on ovarian cancer immunotherapy and vaccine development [2] Company Overview - Anixa is a clinical-stage biotechnology company specializing in cancer treatment and prevention [2] - The company is developing an ovarian cancer immunotherapy program in collaboration with Moffitt Cancer Center, utilizing a novel CAR-T technology called chimeric endocrine receptor-T cell (CER-T) [2] - Anixa's vaccine portfolio includes collaborations with Cleveland Clinic to develop vaccines for breast and ovarian cancer, as well as other cancers like lung, colon, and prostate [2] - The vaccines target "retired" proteins expressed in certain cancers, with exclusive licensing agreements in place with Cleveland Clinic for breast and ovarian cancer vaccines [2] Upcoming Events - The Fireside Chat will be hosted by Robert Sassoon, Managing Director – Healthcare at Water Tower Research, and is open to all investors [2] - Final data from Anixa's Phase 1 breast cancer vaccine trial will be presented on December 11, 2025, at the San Antonio Breast Cancer Symposium [5]

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Core Insights - Anixa Biosciences is a clinical stage biotech company focused on developing innovative CAR-T cell therapy for ovarian cancer and a vaccine for breast cancer [2] Company Overview - Anixa is listed on NASDAQ under the ticker ANIX [2] - The company is engaged in the development of additional predevelopment candidates beyond its primary therapies [2] Leadership - Dr. Amit Kumar serves as the Chairman and CEO of Anixa Biosciences [1]