−Removed: Financial Statements.
−Removed: BIOSCIENCES, INC.
+Added: ANIXA BIOSCIENCES,
AND SUBSIDIARIES
−Removed: CONSOLIDATED BALANCE SHEETS (UNAUDITED)
−Removed: thousands, except share and per share data)
−Removed: July 31, 2024
+Added: CONDENSED CONSOLIDATED BALANCE SHEETS (UNAUDITED)
+Added: (in thousands, except share and per share data)
+Added: January 31, 2025
October 31, 2024
21 unchanged sentences
no shares issued or outstanding
+Added: Preferred stock, value
Common stock, par value $ .01 per share;
100,000,000 shares authorized;
−Removed: 32,146,460 and 31,145,219 shares issued and outstanding as of July 31, 2024 and October 31, 2023, respectively
+Added: 32,196,862 shares issued and outstanding as of January 31, 2025 and October 31, 2024
Additional paid-in capital
Accumulated deficit
+Added: Treasury stock, 2,000 shares at cost
Total shareholders’ equity
1 unchanged sentence
Total liabilities and equity
−Removed: accompanying notes are an integral part of these condensed consolidated financial statements.
−Removed: BIOSCIENCES, INC.
+Added: The accompanying notes are an integral part of these
+Added: condensed consolidated financial statements.
+Added: ANIXA BIOSCIENCES, INC.
AND SUBSIDIARIES
−Removed: CONSOLIDATED STATEMENTS OF OPERATIONS (UNAUDITED)
−Removed: thousands, except per share data)
+Added: CONDENSED CONSOLIDATED STATEMENTS OF OPERATIONS
+Added: (in thousands, except per share data)
For the Three Months Ended
−Removed: For the nine months ended
Operating costs and expenses:
−Removed: Inventor royalties, contingent legal fees, litigation and licensing expenses
Research and development expenses (including non-cash stock-based compensation expenses of $ 397 and $ 489 , respectively)
9 unchanged sentences
Basic and diluted
−Removed: accompanying notes are an integral part of these condensed consolidated financial statements.
−Removed: BIOSCIENCES, INC.
+Added: The accompanying notes are an integral part of these
+Added: condensed consolidated financial statements.
+Added: ANIXA BIOSCIENCES, INC.
AND SUBSIDIARIES
−Removed: CONSOLIDATED STATEMENTS OF EQUITY (UNAUDITED )
−Removed: thousands, except share data)
−Removed: THE THREE MONTHS ENDED JULY 31, 2024
−Removed: Additional Paid-in
−Removed: Total Shareholders’ Equity
−Removed: Non- controlling
−Removed: Additional Paid-in
−Removed: Total Shareholders’ Equity
−Removed: Non- controlling
−Removed: Balance, April 30, 2024
−Removed: $ ( 234,590 )
+Added: CONDENSED CONSOLIDATED STATEMENTS OF EQUITY
+Added: (in thousands, except share data)
+Added: FOR THE THREE MONTHS ENDED JANUARY 31, 2025 (UNAUDITED )
+Added: Shareholders’
+Added: Balance, October 31, 2024
Stock option compensation to employees and directors
Stock options issued to consultants
−Removed: Offering expenses related to an at-the-market offering
−Removed: Common stock issued in an at-the-market offering, net of offering expenses of $139
−Removed: Common stock issued in an at-the-market offering, net of
−Removed: offering expenses of $139, shares
−Removed: Common stock issued upon exercise of stock options
Common stock issued to consultants
−Removed: Common stock issued pursuant to an employee stock purchase plan
−Removed: Common stock issued pursuant to an employee stock purchase
−Removed: Balance, July 31, 2024
−Removed: $ ( 237,867 )
−Removed: THE THREE MONTHS ENDED JULY 31, 2023
−Removed: Additional Paid-in
−Removed: Total Shareholders’
−Removed: Non- controlling
−Removed: Additional Paid-in
−Removed: Total Shareholders’
−Removed: Non- controlling
−Removed: Balance, April 30, 2023
−Removed: $ ( 222,995 )
−Removed: Stock option compensation to employees and directors
−Removed: Stock options issued to consultants
+Added: Common stock issued to consultants, shares
+Added: Common stock issued in an at-the-market offering, net of offering expenses
+Added: Common stock issued in an at-the-market offering, net of offering expenses, shares
Common stock issued upon exercise of stock options
−Removed: Common stock issued to consultants
−Removed: Balance, July 31, 2023
−Removed: $ ( 225,506 )
−Removed: accompanying notes are an integral part of these condensed consolidated financial statements.
−Removed: BIOSCIENCES, INC.
−Removed: AND SUBSIDIARIES
−Removed: CONSOLIDATED STATEMENTS OF EQUITY (UNAUDITED )
−Removed: thousands, except share data)
−Removed: THE NINE MONTHS ENDED JULY 31, 2024
−Removed: Additional Paid-in
−Removed: Total Shareholders’
−Removed: Non- controlling
−Removed: Additional Paid-in
−Removed: Total Shareholders’
−Removed: Non- controlling
+Added: Common stock issued upon exercise of stock options, shares
+Added: Expenses related to an at-the-market offering
+Added: Balance, January 31, 2025
+Added: FOR THE THREE MONTHS ENDED JANUARY 31, 2024
+Added: Shareholders’
+Added: Shareholders’
Balance, October 31, 2023
−Removed: $ ( 228,196 )
Stock option compensation to employees and directors
Stock options issued to consultants
−Removed: Common stock issued in an at-the-market offering, net of offering expenses of $ 139
−Removed: Common stock issued upon exercise of stock options
Common stock issued to consultants
−Removed: Common stock issued pursuant to an employee stock purchase plan
−Removed: Balance, July 31, 2024
−Removed: $ ( 237,867 )
−Removed: THE NINE MONTHS ENDED JULY 31, 2023
−Removed: Additional Paid-in
−Removed: Total Shareholders’
−Removed: Non- controlling
−Removed: Additional Paid-in
−Removed: Total Shareholders’
−Removed: Non- controlling
−Removed: Balance, October 31, 2022
−Removed: $ ( 218,385 )
−Removed: $ ( 218,385 )
−Removed: Stock option compensation to employees and directors
−Removed: Stock options issued to consultants
+Added: Common stock issued in an at-the-market offering, net of offering expenses of $ 68
Common stock issued upon exercise of stock options
−Removed: Common stock issued to consultants
−Removed: Common stock issued pursuant to an employee stock purchase plan
−Removed: Balance, July 31, 2023
−Removed: $ ( 225,506 )
−Removed: $ ( 225,506 )
−Removed: accompanying notes are an integral part of these condensed consolidated financial statements.
−Removed: BIOSCIENCES, INC.
+Added: Balance, January 31, 2024
+Added: The accompanying notes are an integral part of these
+Added: condensed consolidated financial statements.
+Added: ANIXA BIOSCIENCES, INC.
AND SUBSIDIARIES
−Removed: CONSOLIDATED STATEMENTS OF CASH FLOWS (UNAUDITED)
−Removed: For the nine months ended
+Added: CONDENSED CONSOLIDATED STATEMENTS OF CASH FLOWS
+Added: (in thousands)
+Added: For the three months ended
Cash flows from operating activities:
4 unchanged sentences
Amortization of operating lease right-of-use asset
+Added: Amortization of discount on held-to-maturity securities
Change in operating assets and liabilities:
7 unchanged sentences
Proceeds from maturities of short-term investments
−Removed: Net cash provided by (used in) investing activities
+Added: Net cash provided by investing activities
Cash flows from financing activities:
−Removed: Proceeds from sale of common stock in an at-the-market offering, net of offering expenses of $ 139
−Removed: Proceeds from sale of common stock pursuant to an employee stock purchase plan
+Added: Net (expenses) proceeds from an at-the-market
Proceeds from exercise of stock options
−Removed: Net cash provided by financing activities
−Removed: Net increase (decrease) in cash and cash equivalents
+Added: Net cash (used in) provided by financing activities
+Added: Net (decrease) increase in cash and cash equivalents
Cash and cash equivalents at beginning of period
Cash and cash equivalents at end of period
−Removed: Supplemental disclosure of non-cash investing activity:
−Removed: Operating lease right-of-use asset
−Removed: Supplemental disclosure of non-cash financing activity:
−Removed: Operating lease liability
−Removed: accompanying notes are an integral part of these condensed consolidated financial statements.
−Removed: BIOSCIENCES, INC.
+Added: The accompanying notes are an integral part of these
+Added: condensed consolidated financial statements.
+Added: ANIXA BIOSCIENCES, INC.
AND SUBSIDIARIES
−Removed: TO CONDENSED CONSOLIDATED FINANCIAL STATEMENTS
+Added: NOTES TO CONDENSED CONSOLIDATED FINANCIAL STATEMENTS
BUSINESS AND FUNDING
−Removed: used herein, “we,” “us,” “our,” the “Company” or “Anixa” means Anixa Biosciences,
−Removed: and its consolidated subsidiaries unless otherwise indicated.
−Removed: Biosciences, Inc.
−Removed: is a biotechnology company developing vaccines and therapies that are focused on critical unmet needs in oncology.
+Added: Description of Business
+Added: As used herein, “we,”
+Added: “us,” “our,” the “Company” or “Anixa” means Anixa Biosciences, Inc.
+Added: and its consolidated
+Added: subsidiaries.
+Added: Anixa Biosciences, Inc.
+Added: is a biotechnology
+Added: company developing therapies and vaccines that are focused on critical unmet needs in oncology.
+Added: Our therapeutics program consists of the
+Added: development of a chimeric endocrine receptor-T cell therapy, a novel form of chimeric antigen receptor-T cell (“CAR-T”) technology,
+Added: initially focused on treating ovarian cancer, which is being developed at our subsidiary, Certainty Therapeutics, Inc.
+Added: (“Certainty”).
Our vaccine programs include (i) the development of a vaccine against breast cancer, initially focused on triple negative breast cancer
2 unchanged sentences
many intractable cancers, including high incidence malignancies in lung, colon and prostate.
−Removed: Our therapeutics programs include (i) the
−Removed: development of a chimeric endocrine receptor T cell therapy, a novel form of chimeric antigen receptor T cell (“CAR-T”) technology,
−Removed: initially focused on treating ovarian cancer, which is being developed at our subsidiary, Certainty Therapeutics, Inc.
−Removed: (“Certainty”),
−Removed: and (ii) until March 2023, the development of anti-viral drug candidates for the treatment of Covid-19.
−Removed: hold an exclusive worldwide, royalty-bearing license to use certain intellectual property owned or controlled by The Cleveland Clinic
−Removed: Foundation (“Cleveland Clinic”) relating to certain breast cancer vaccine technology developed at Cleveland Clinic.
−Removed: agreement requires us to make certain cash payments to Cleveland Clinic upon achievement of specific development milestones.
−Removed: this technology, we are working in collaboration with Cleveland Clinic to develop a method to vaccinate women against contracting breast
−Removed: cancer, focused initially on TNBC.
−Removed: The focus of this vaccine is a specific protein, α-lactalbumin, that is only expressed during
−Removed: lactation in a healthy woman’s mammary tissue.
−Removed: This protein disappears when the woman is no longer lactating, but reappears in
−Removed: many forms of breast cancer, especially TNBC.
−Removed: Studies have shown that vaccinating against this protein prevents breast cancer in mice.
−Removed: October 2021, following the U.S.
−Removed: Food and Drug Administration’s (“FDA”) authorization to proceed, we commenced
−Removed: dosing patients in a Phase 1 clinical trial of our breast cancer vaccine.
−Removed: This study, which is being fully funded by a U.S.
−Removed: Department of Defense grant to Cleveland Clinic, is a multiple-ascending dose Phase 1 trial to determine the maximum tolerated dose
−Removed: (“MTD”) of the vaccine in patients with early-stage, triple-negative breast cancer as well as monitor immune response.
−Removed: The study is being conducted at Cleveland Clinic.
−Removed: During the course of the Phase 1 study, participants will receive three
−Removed: vaccinations, each two weeks apart, and will be closely monitored for side effects and immune response.
−Removed: The first segment of the
−Removed: study, Phase 1a, will consist of approximately 24 patients who have completed treatment for early-stage, triple-negative breast
−Removed: cancer within the past three years and are currently tumor-free but at high risk for recurrence.
−Removed: Studies show that 42% of TNBC
−Removed: patients will have a recurrence of their cancer, with most of the recurrences occurring in the first two to three years after
−Removed: standard of care treatment.
−Removed: In January 2023, the number of participants in each dose cohort was expanded, and as of August 2023, we
−Removed: had completed vaccinating all patients in these expanded cohorts.
−Removed: In December 2023, we presented the immunological data collected to
−Removed: date at the San Antonio Breast Cancer Symposium.
−Removed: The data presented show that in the vaccinated women who had been tested to date,
−Removed: various levels of antigen-specific T cell responses were observed at all dose levels.
−Removed: Subsequently, we began vaccinating
−Removed: participants in additional dose cohorts at varying dose levels of the different key components of the vaccine.
−Removed: Further, in November
−Removed: 2023, we commenced vaccination of participants in the second segment of the trial, Phase 1b, that includes participants who have
−Removed: never had cancer, but carry certain mutations in genes such as BRCA1, BRCA2 or PALB2, that indicate a greater risk of developing
−Removed: TNBC in the future, and have elected to have a prophylactic mastectomy.
−Removed: Finally, in January 2024, we commenced vaccination of
−Removed: participants in the third segment of the trial, Phase 1c, that includes post-operative TNBC patients that have residual disease
−Removed: following treatment and are currently undergoing treatment with pembrolizumab (Keytruda®).
−Removed: We anticipate presenting the most
−Removed: recent data from each of the three arms of the trial at the Society for Immunotherapy of Cancer (SITC) Annual Meeting in November
−Removed: hold an exclusive worldwide, royalty-bearing license to use certain intellectual property owned or controlled by Cleveland Clinic relating
−Removed: to certain ovarian cancer vaccine technology.
−Removed: The license agreement requires us to make certain cash payments to Cleveland Clinic upon
−Removed: achievement of specific development milestones.
−Removed: This technology pertains to among other things, the use of vaccines for the treatment
−Removed: or prevention of ovarian cancers which express the anti-Mullerian hormone receptor 2 protein containing an extracellular domain (“AMHR2-ED”).
−Removed: In healthy tissue, this protein regulates growth and development of egg-containing follicles in the ovary.
−Removed: While expression of AMHR2-ED
−Removed: naturally and markedly declines during menopause, this protein is expressed at high levels in the ovaries of postmenopausal women with
−Removed: ovarian cancer.
−Removed: Researchers at Cleveland Clinic believe that a vaccine targeting AMHR2-ED could prevent the occurrence of ovarian cancer.
−Removed: May 2021, Cleveland Clinic was granted acceptance for our ovarian cancer vaccine technology into the National Cancer Institute’s
−Removed: (“NCI”) PREVENT program.
−Removed: The NCI is a part of the National Institutes of Health (“NIH”).
−Removed: The PREVENT program
−Removed: is a peer-reviewed agent development program designed to support pre-clinical development of innovative interventions and biomarkers
−Removed: for cancer prevention and interception towards clinical trials.
−Removed: The scientific and financial resources of the PREVENT program are being
−Removed: used for our ovarian cancer vaccine technology to perform virtually all pre-clinical research and development, manufacturing and Investigational
−Removed: New Drug (“IND”) application enabling studies.
−Removed: This work is being performed at NCI facilities, by NCI scientific staff and
−Removed: with NCI financial resources and will require no material financial expenditures by the Company, nor the payment of any future consideration
−Removed: by the Company to NCI.
−Removed: May 2024, based on the positive clinical results to date in the development of our breast cancer vaccine, we entered into a Joint Development
−Removed: and Option Agreement with Cleveland Clinic to collaborate in efforts to develop additional vaccines for the prevention or treatment of
−Removed: Working with Cleveland Clinic researchers, we will focus on the same novel scientific mechanism as in our breast and ovarian
−Removed: cancer vaccines, and work to discover additional retired proteins that may be associated with other forms of cancer, specifically high
−Removed: incidence malignancies in the lung, colon and prostate.
−Removed: subsidiary, Certainty, is developing immuno-therapy drugs against cancer.
−Removed: Certainty holds an exclusive worldwide, royalty-bearing license
−Removed: to use certain intellectual property owned or controlled by The Wistar Institute (“Wistar”), the nation’s first independent
−Removed: biomedical research institute and a leading NCI designated cancer research center, relating to Wistar’s chimeric endocrine receptor
−Removed: targeted therapy technology.
−Removed: We have initially focused on the development of a treatment for ovarian cancer, but we also may pursue applications
−Removed: of the technology for the development of treatments for additional solid tumors.
−Removed: The license agreement requires Certainty to make certain
−Removed: cash and equity payments to Wistar upon achievement of specific development milestones.
+Added: Our subsidiary, Certainty, is
+Added: developing immuno-therapy drugs against cancer.
+Added: Certainty holds an exclusive worldwide, royalty-bearing license to use certain intellectual
+Added: property owned or controlled by The Wistar Institute (“Wistar”), the nation’s first independent biomedical research
+Added: institute and a leading NCI designated cancer research center, relating to Wistar’s chimeric endocrine receptor targeted therapy
+Added: We have initially focused on the development of a treatment for ovarian cancer, but we also may pursue applications of the
+Added: technology for the development of treatments for additional solid tumors.
+Added: The license agreement requires Certainty to make certain cash
+Added: and equity payments to Wistar upon achievement of specific development milestones.
With respect to Certainty’s equity obligations
2 unchanged sentences
Due to such Company funding, Wistar’s
−Removed: equity stake in Certainty was 4.4 % as of July 31, 2024.
−Removed: in collaboration with the H.
+Added: equity stake in Certainty was 4.3 % as of January 31, 2025.
+Added: Certainty, in collaboration with
Lee Moffitt Cancer Center and Research Institute, Inc.
−Removed: (“Moffitt”), has begun human clinical
−Removed: testing of the CAR-T technology licensed by Certainty from Wistar aimed initially at treating ovarian cancer.
−Removed: After receiving authorization
−Removed: from the FDA, we commenced enrollment of patients in a Phase 1 clinical trial and treated the first patient in August 2022.
−Removed: in May 2023 and August 2023, we treated the second and third patients in the trial, respectively, at the same dose level as the first
−Removed: patient, and the treatment was well-tolerated by the patients.
−Removed: In February 2024, May 2024 and June 2024, we treated the three patients,
−Removed: respectively, of the second dose cohort, where the patients were administered a three-times higher dose of cells than the patients in
−Removed: the first cohort.
−Removed: The treatment appears to have been well-tolerated by the patients.
−Removed: While the dose levels in the first two cohorts were
−Removed: expected to be sub-therapeutic, two of the six patients treated to date are exhibiting some anecdotal signs of efficacy.
−Removed: Both have shown
−Removed: signs of tumor necrosis, and one is more than 16 months past initial treatment.
−Removed: In the case of this patient, due to the encouraging results
−Removed: with her initial treatment, we sought single patient IND permission from the FDA to re-dose her.
−Removed: This re-dosing has been approved by
−Removed: the FDA, and we anticipate administering her second treatment in the coming weeks.
−Removed: study is a dose-escalation trial with two arms based on route of delivery—intraperitoneal or intravenous—to determine the
−Removed: maximum tolerated dose in patients with recurrent epithelial ovarian cancer and to assess persistence, expansion and efficacy of the
−Removed: modified T cells.
−Removed: The study is being conducted at Moffitt and will consist of up to 24 to 48 patients who have received at least two
−Removed: prior lines of chemotherapy.
−Removed: The study is estimated to be completed in two to four years depending on multiple factors including when
−Removed: the maximum tolerated dose is reached, the rate of patient enrollment, the significance of efficacy data and how long we maintain the
−Removed: two different delivery methods.
−Removed: the next several quarters, we expect the development of our vaccines and therapeutics to be the primary focus of the Company.
−Removed: of our legacy operations, the Company remains engaged in limited patent licensing activities of its various patent portfolios.
−Removed: not expect these activities to be a significant part of the Company’s ongoing operations nor do we expect these activities to require
−Removed: material financial resources or attention of senior management.
−Removed: the past several years, our revenue was derived from technology licensing and the sale of patented technologies, including revenue from
−Removed: the settlement of litigation.
+Added: (“Moffitt”), has begun human clinical testing of the CAR-T technology
+Added: licensed by Certainty from Wistar aimed initially at treating ovarian cancer.
+Added: After receiving authorization from the FDA, we commenced
+Added: enrollment of patients in a Phase 1 clinical trial and treated the first patient in August 2022.
+Added: Further, in May 2023 and August 2023,
+Added: we treated the second and third patients in the trial, respectively, at the same dose level as the first patient, and the treatment was
+Added: well-tolerated by the patients.
+Added: In February 2024, May 2024 and June 2024, we treated the three patients, respectively, of the second dose
+Added: cohort, where the patients were administered a three-times higher dose of cells than the patients in the first cohort.
+Added: The treatment at
+Added: this dose level has also been well-tolerated by the patients.
+Added: While the dose levels in the first two cohorts were expected to be sub-therapeutic,
+Added: two of the six patients exhibited some anecdotal signs of efficacy.
+Added: Both have shown possible signs of tumor necrosis, and one is still
+Added: alive nearly 2 years past initial treatment.
+Added: In the case of this patient, due to the encouraging results with her initial treatment, we
+Added: sought single patient Investigational New Drug (“IND”) application permission from the FDA to re-dose her.
+Added: This re-dosing
+Added: was approved by the FDA, and we administered her second treatment in October 2024.
+Added: This second treatment appears to have been well-tolerated
+Added: by the patient.
+Added: From November 2024 to February 2025, we treated three patients in the third dose cohort, where they were administered
+Added: a ten-times higher dose of cells than the patients in the first dose cohort.
+Added: Consistent with the lower dose cohorts, the treatment appears
+Added: to have been well-tolerated by the patients.
+Added: As of March 11, 2025, we are preparing to enroll patients in the 4 th dose cohort,
+Added: where we will be administering a 30-times higher dose than the original dose cohort.
+Added: This study is a dose-escalation
+Added: trial with two arms based on route of delivery—intraperitoneal or intravenous—to determine the maximum tolerated dose in patients
+Added: with recurrent epithelial ovarian cancer and to assess persistence, expansion and efficacy of the modified T cells.
+Added: The study is being
+Added: conducted at Moffitt and will consist of up to 24 to 48 patients who have received at least two prior lines of chemotherapy.
+Added: is estimated to be completed in two to three years depending on multiple factors including when the maximum tolerated dose is reached,
+Added: the rate of patient enrollment, the significance of efficacy data and how long we maintain the two different delivery methods.
+Added: We hold an exclusive worldwide,
+Added: royalty-bearing license to use certain intellectual property owned or controlled by The Cleveland Clinic Foundation (“Cleveland
+Added: Clinic”) relating to certain breast cancer vaccine technology developed at Cleveland Clinic.
+Added: The license agreement requires us to
+Added: make certain cash payments to Cleveland Clinic upon achievement of specific development milestones.
+Added: Utilizing this technology, we are
+Added: working in collaboration with Cleveland Clinic to develop a method to vaccinate women against breast cancer, focused initially on TNBC.
+Added: The focus of this vaccine is a specific protein, α-lactalbumin, that is only expressed during lactation in a healthy woman’s
+Added: mammary tissue.
+Added: This protein disappears when the woman is no longer lactating, but reappears in many forms of breast cancer, especially
+Added: Studies have shown that vaccinating against this protein prevents breast cancer in mice.
+Added: In October 2021, following the
+Added: Food and Drug Administration’s (“FDA”) authorization to proceed, we commenced dosing patients in a Phase 1 clinical
+Added: trial of our breast cancer vaccine.
+Added: This study, which is being fully funded by a U.S.
+Added: Department of Defense grant to Cleveland Clinic,
+Added: is a multiple-ascending dose Phase 1 trial to determine the maximum tolerated dose (“MTD”) of the vaccine in patients with
+Added: early-stage, triple-negative breast cancer as well as monitor immune response.
+Added: The study is being conducted at Cleveland Clinic.
+Added: the course of the Phase 1 study, participants will receive three vaccinations, each two weeks apart, and will be closely monitored for
+Added: side effects and immune response.
+Added: The first segment of the study, Phase 1a, will consist of approximately 24 patients who have completed
+Added: treatment for early-stage, triple-negative breast cancer within the past three years and are currently tumor-free but at high risk for
+Added: Studies show that 42% of TNBC patients will have a recurrence of their cancer, with most of the recurrences occurring in the
+Added: first two to three years after standard of care treatment.
+Added: In January 2023, the number of participants in each dose cohort was expanded,
+Added: and as of August 2023, we had completed vaccinating all patients in these expanded cohorts.
+Added: In December 2023, we presented the immunological
+Added: data collected to date at the San Antonio Breast Cancer Symposium.
+Added: The data presented show that in the vaccinated women who had been tested
+Added: to date, various levels of antigen-specific T cell responses were observed at all dose levels.
+Added: Subsequently, we began vaccinating participants
+Added: in additional dose cohorts at varying dose levels of the different key components of the vaccine.
+Added: Further, in November 2023, we commenced
+Added: vaccination of participants in the second segment of the trial, Phase 1b, that includes participants who have never had cancer, but carry
+Added: certain mutations in genes such as BRCA1, BRCA2 or PALB2, that indicate a greater risk of developing TNBC in the future, and have elected
+Added: to have a prophylactic mastectomy.
+Added: Finally, in January 2024, we commenced vaccination of participants in the third segment of the trial,
+Added: Phase 1c, that includes post-operative TNBC patients that have residual disease following treatment and are currently undergoing treatment
+Added: with pembrolizumab (Keytruda®).
+Added: In November 2024, we presented the most recent data from each of the three arms of the trial at the
+Added: Society for Immunotherapy of Cancer (SITC) Annual Meeting.
+Added: Key findings presented include i) patients exhibited antigen-specific immune
+Added: responses at all dose levels and in all three patient groups (Phase 1a, 1b and 1c), ii) patients receiving our vaccine in combination
+Added: with Keytruda are not showing any additional or more severe adverse side effects, and iii) no adverse side effects were seen other than
+Added: varying degrees of injection site irritation.
+Added: These findings are promising, and as we continue the Phase 1 trial, we are preparing to
+Added: initiate a Phase 2 clinical trial in the neo-adjuvant setting (pre-surgery) to determine possible therapeutic effect of the vaccine.
+Added: anticipate commencing the Phase 2 trial in 2025.
+Added: We hold an exclusive worldwide,
+Added: royalty-bearing license to use certain intellectual property owned or controlled by Cleveland Clinic relating to certain ovarian cancer
+Added: vaccine technology.
+Added: The license agreement requires us to make certain cash payments to Cleveland Clinic upon achievement of specific development
+Added: This technology pertains to among other things, the use of vaccines for the treatment or prevention of ovarian cancers which
+Added: express the anti-Mullerian hormone receptor 2 protein containing an extracellular domain (“AMHR2-ED”).
+Added: In healthy tissue,
+Added: this protein regulates growth and development of egg-containing follicles in the ovary.
+Added: While expression of AMHR2-ED naturally and markedly
+Added: declines during menopause, this protein is expressed at high levels in the ovaries of postmenopausal women with ovarian cancer.
+Added: at Cleveland Clinic believe that a vaccine targeting AMHR2-ED could prevent the occurrence of ovarian cancer.
+Added: In May 2021, Cleveland Clinic
+Added: was granted acceptance for our ovarian cancer vaccine technology into the National Cancer Institute’s (“NCI”) PREVENT
+Added: The NCI is a part of the National Institutes of Health (“NIH”).
+Added: The PREVENT program is a peer-reviewed agent development
+Added: program designed to support pre-clinical development of innovative interventions and biomarkers for cancer prevention and interception
+Added: towards clinical trials.
+Added: The scientific and financial resources of the PREVENT program are being used for our ovarian cancer vaccine technology
+Added: to perform virtually all pre-clinical research and development, manufacturing and IND enabling studies.
+Added: This work is being performed at
+Added: NCI facilities, by NCI scientific staff and with NCI financial resources and will require no material financial expenditures by the Company,
+Added: nor the payment of any future consideration by the Company to NCI.
+Added: In May 2024, based on the positive
+Added: clinical results to date in the development of our breast cancer vaccine, we entered into a Joint Development and Option Agreement with
+Added: Cleveland Clinic to collaborate in efforts to develop additional vaccines for the prevention or treatment of cancers.
+Added: Working with Cleveland
+Added: Clinic researchers, we are focusing on the same novel scientific mechanism as in our breast and ovarian cancer vaccines, and working to
+Added: discover additional retired proteins that may be associated with other forms of cancer, specifically high incidence malignancies in the
+Added: lung, colon and prostate.
+Added: Over the next several quarters,
+Added: we expect the development of our therapeutics and vaccines to be the primary focus of the Company.
+Added: As part of our legacy operations, the
+Added: Company remains engaged in limited patent licensing activities of its various patent portfolios.
+Added: We do not expect these activities to
+Added: be a significant part of the Company’s ongoing operations nor do we expect these activities to require material financial resources
+Added: or attention of senior management.
+Added: Over the past several years, our
+Added: revenue was derived from technology licensing and the sale of patented technologies, including revenue from the settlement of litigation.
We have not generated any revenue to date from our vaccine or therapeutics programs.
−Removed: In addition, while
−Removed: we pursue our vaccine and therapeutics programs, we may also make investments in and form new companies to develop additional emerging
−Removed: technologies.
−Removed: We do not expect to begin generating revenue with respect to any of our current vaccine or therapy programs in the near
−Removed: We hope to achieve a profitable outcome by eventually licensing our technologies to large pharmaceutical companies that have the
−Removed: resources and infrastructure in place to manufacture, market and sell our technologies as vaccines or therapeutics.
−Removed: The eventual licensing
−Removed: of any of our technologies may take several years, if it is to occur at all, and may depend on positive results from human clinical trials.
−Removed: and Management’s Plans
−Removed: on currently available information as of September 6, 2024, we believe that our existing cash, cash equivalents, short-term investments
−Removed: and expected cash flows will be sufficient to fund our activities for at least the next twelve months.
−Removed: The Company has approximately $ 20,745,000 of cash, cash equivalents, and
−Removed: short-term investments at July 31, 2024 compared to approximately $ 23,844,000 at October 31, 2023 which is a reduction of approximately
−Removed: $ 3,099,000 during the nine months ended July 31, 2024.
−Removed: Therefore, the Company believes that it has sufficient cash, cash equivalents,
−Removed: and short-term investments to operate its business, as currently contemplated, for significantly longer than 12 months from the date of
−Removed: We have implemented a business
−Removed: model that conserves funds by collaborating with third parties to develop our technologies.
−Removed: During the nine months ended July 31, 2024, we raised approximately $ 2,984,000 , net of expenses, through
−Removed: an at-the-market equity offering of 785,290 shares of common stock, under which offering we may issue up to $ 100 million of common stock.
−Removed: Under our at-the-market equity program, which is currently effective and may remain available for us to use in the future, as of July
−Removed: 31, 2024, we may sell an additional approximately $ 97 million of common stock.
+Added: In addition, while we pursue our vaccine and therapeutics
+Added: programs, we may also make investments in and form new companies to develop additional emerging technologies.
+Added: We do not expect to begin
+Added: generating revenue with respect to any of our current vaccine or therapy programs in the near term.
+Added: We hope to achieve a profitable outcome
+Added: by eventually licensing our technologies to large pharmaceutical companies that have the resources and infrastructure in place to manufacture,
+Added: market and sell our technologies as vaccines or therapeutics.
+Added: The eventual licensing of any of our technologies may take several years,
+Added: if it is to occur at all, and may depend on positive results from human clinical trials.
+Added: Funding and Management’s Plans
+Added: Based on currently available information as of March 11, 2025, we believe
+Added: that our existing cash, cash equivalents and short-term investments will be sufficient to fund our activities for at least the next twelve
+Added: The Company had approximately $ 18,686,000 of total current assets at January 31, 2025 compared to approximately $ 21,362,000 at
+Added: October 31, 2024 which is a reduction of approximately $ 2,676,000 for the three months ended January 31, 2025.
+Added: Therefore, the Company
+Added: believes that it has sufficient cash, cash equivalents and short-term investments to operate its business, as currently contemplated,
+Added: for significantly longer than 12 months from the date of this Report.
+Added: We have implemented a business model that conserves funds by collaborating
+Added: with third parties to develop our technologies.
+Added: During the three months ended January 31, 2025, we did not issue any shares under our
+Added: at-the-market equity offering.
+Added: Under our at-the-market equity program, which is currently effective and may remain available for us to
+Added: use in the future, as of January 31, 2025, we may sell approximately $ 97 million of common stock.
SIGNIFICANT ACCOUNTING POLICIES
−Removed: of Presentation
−Removed: accompanying unaudited condensed consolidated financial statements have been prepared in accordance with generally accepted accounting
−Removed: principles in the United States of America (“US GAAP”) for interim financial information and with the instructions to Form
−Removed: 10-Q and Rule 8-03 of Regulation S-X.
−Removed: Accordingly, certain information and disclosures required by generally accepted accounting principles
−Removed: in annual financial statements have been omitted or condensed.
−Removed: These interim condensed consolidated financial statements should be read
−Removed: in conjunction with the audited consolidated financial statements and related disclosures included in our Annual Report on Form 10-K
−Removed: for the fiscal year ended October 31, 2023.
−Removed: The accompanying October 31, 2023 condensed consolidated balance sheet data was derived from
−Removed: the audited financial statements but does not include all disclosures required by US GAAP.
−Removed: The condensed consolidated financial statements
−Removed: include all adjustments of a normal recurring nature which, in the opinion of management, are necessary for a fair statement of our financial
−Removed: position as of July 31, 2024, and results of operations and cash flows for the interim periods represented.
−Removed: The results of operations
−Removed: for the three and nine months ended July 31, 2024 are not necessarily indicative of the results to be expected for the year.
−Removed: Noncontrolling
−Removed: Noncontrolling
−Removed: interest represents Wistar’s equity ownership in Certainty and is presented as a component of equity.
−Removed: The following table sets
−Removed: forth the changes in noncontrolling interest for the nine months ended July 31, 2024 (in thousands):
−Removed: OF CHANGES IN NONCONTROLLING INTEREST
+Added: Basis of Presentation
+Added: The accompanying unaudited condensed
+Added: consolidated financial statements have been prepared in accordance with generally accepted accounting principles in the United States
+Added: of America (“US GAAP”) for interim financial information and with the instructions to Form 10-Q and Rule 8-03 of Regulation
+Added: Accordingly, certain information and disclosures required by generally accepted accounting principles in annual financial statements
+Added: have been omitted or condensed.
+Added: These interim condensed consolidated financial statements should be read in conjunction with the audited
+Added: consolidated financial statements and related disclosures included in our Annual Report on Form 10-K for the fiscal year ended October
+Added: The accompanying October 31, 2024 condensed consolidated balance sheet data was derived from the audited financial statements
+Added: but does not include all disclosures required by US GAAP.
+Added: The condensed consolidated financial statements include all adjustments of a
+Added: normal recurring nature which, in the opinion of management, are necessary for a fair statement of our financial position as of January
+Added: 31, 2025, and results of operations and cash flows for the interim periods represented.
+Added: The results of operations for the three months
+Added: ended January 31, 2025 are not necessarily indicative of the results to be expected for the year.
+Added: Noncontrolling Interest
+Added: Noncontrolling interest represents
+Added: Wistar’s equity ownership in Certainty and is presented as a component of equity.
+Added: The following table sets forth the changes in
+Added: noncontrolling interest for the three months ended January 31, 2025 (in thousands):
+Added: SCHEDULE OF CHANGES IN NONCONTROLLING INTEREST
Balance, October 31, 2024
Net loss attributable to noncontrolling interest
−Removed: Balance, July 31, 2024
−Removed: revenue has been derived solely from technology licensing and the sale of patented technologies.
−Removed: Revenue is recognized upon transfer
−Removed: of control of intellectual property rights and satisfaction of other contractual performance obligations to licensees in an amount that
−Removed: reflects the consideration we expect to receive.
−Removed: revenue recognition policy requires us to make certain judgments and estimates in connection with the accounting for revenue.
−Removed: may include determining the existence of a contract and identifying each party’s rights and obligations to transfer goods and services,
−Removed: identifying the performance obligations in the contract, determining the transaction price and allocating the transaction price to separate
−Removed: performance obligations, estimating the timing of satisfaction of performance obligations, determining whether a promise to grant a license
−Removed: is distinct from other promised goods or services and evaluating whether a license transfers to a customer at a point in time or over
−Removed: revenue arrangements provide for the payment, within 30 days of execution of the agreement, of contractually determined, one-time, paid-up
−Removed: license fees in settlement of litigation and in consideration for the grant of certain intellectual property rights for patented technologies
+Added: Balance, January 31, 2025
+Added: Revenue Recognition
+Added: has been derived solely from technology licensing and the sale of patented technologies.
+Added: Revenue is recognized upon transfer of control
+Added: of intellectual property rights and satisfaction of other contractual performance obligations to licensees in an amount that reflects
+Added: the consideration we expect to receive.
+Added: recognition policy requires us to make certain judgments and estimates in connection with the accounting for revenue.
+Added: Such areas may include
+Added: determining the existence of a contract and identifying each party’s rights and obligations to transfer goods and services, identifying
+Added: the performance obligations in the contract, determining the transaction price and allocating the transaction price to separate performance
+Added: obligations, estimating the timing of satisfaction of performance obligations, determining whether a promise to grant a license is distinct
+Added: from other promised goods or services and evaluating whether a license transfers to a customer at a point in time or over time.
+Added: arrangements provide for the payment, within 30 days of execution of the agreement, of contractually determined, one-time, paid-up license
+Added: fees in settlement of litigation and in consideration for the grant of certain intellectual property rights for patented technologies
owned or controlled by the Company.
3 unchanged sentences
(ii) a covenant-not-to-sue, (iii) the release of the licensee from certain claims, and (iv) the dismissal of any pending litigation.
−Removed: In such instances, the intellectual property rights granted have been perpetual in nature, extending until the expiration of the related
−Removed: Pursuant to the terms of these agreements, we have no further obligations with respect to the granted intellectual property
−Removed: rights, including no obligation to maintain or upgrade the technology, or provide future support or services.
−Removed: Licensees obtained control
−Removed: of the intellectual property rights they have acquired upon execution of the agreement.
−Removed: Accordingly, the performance obligations from
−Removed: these agreements were satisfied and 100 % of the revenue was recognized upon the execution of the agreements.
−Removed: of revenues include the costs and expenses incurred in connection with our patent licensing and enforcement activities, including inventor
−Removed: royalties paid to original patent owners, contingent legal fees paid to external counsel, other patent-related legal expenses paid to
−Removed: external counsel and licensing and enforcement related research, consulting and other expenses paid to third-parties.
−Removed: These costs are
−Removed: included under the caption “Operating costs and expenses” in the accompanying condensed consolidated statements of operations.
−Removed: and Development Expenses
−Removed: and development expenses consist primarily of employee compensation, payments to third parties for research and development activities
−Removed: and other direct costs associated with developing our therapeutics and vaccines.
+Added: such instances, the intellectual property rights granted have been perpetual in nature, extending until the expiration of the related
+Added: Pursuant to the terms of these agreements, we have no further obligations with respect to the granted intellectual property rights,
+Added: including no obligation to maintain or upgrade the technology, or provide future support or services.
+Added: Licensees obtained control of the
+Added: intellectual property rights they have acquired upon execution of the agreement.
+Added: Accordingly, the performance obligations from these agreements
+Added: were satisfied and 100 % of the revenue was recognized upon the execution of the agreements.
+Added: Cost of Revenues
+Added: Cost of revenues include the costs
+Added: and expenses incurred in connection with our patent licensing and enforcement activities, including inventor royalties paid to original
+Added: patent owners, contingent legal fees paid to external counsel, other patent-related legal expenses paid to external counsel, licensing
+Added: and enforcement related research and consulting and other expenses paid to third-parties.
+Added: These costs are included under the caption “Operating
+Added: costs and expenses” in the accompanying consolidated statements of operations.
+Added: Research and Development Expenses
+Added: Research and development expenses
+Added: consist primarily of employee compensation, payments to third parties for research and development activities and other direct costs associated
+Added: with developing our therapeutics and vaccines.
We recognize research and development expenses as incurred.
−Removed: Advance payments for future research and development activities are deferred and expensed as the services are performed.
−Removed: our preclinical studies and clinical trial expenses based on the services performed pursuant to contracts with research institutions,
−Removed: clinical research organizations (“CROs”), clinical manufacturing organizations (“CMOs”), and other parties that
−Removed: conduct and manage various stages of research and development activities on our behalf.
−Removed: Fees for such services are recognized based on
−Removed: management’s estimates after considering the activities and tasks completed by each service provider in a given period, the time
−Removed: period over which services are expected to be performed, and the level of effort expended in each reporting period.
−Removed: Company’s investment policy is to acquire U.S.
−Removed: government debt securities with fixed maturities and contractual cash flows that
−Removed: the Company has the positive intent and ability to hold to maturity.
−Removed: These securities are recorded at amortized cost, net of any applicable
−Removed: discount which is amortized to interest income, and are accounted for as held-to-maturity securities.
+Added: Advance payments for future
+Added: research and development activities are deferred and expensed as the services are performed.
+Added: We recognize our preclinical studies and
+Added: clinical trial expenses based on the services performed pursuant to contracts with research institutions, clinical research organizations
+Added: (“CROs”), clinical manufacturing organizations (“CMOs”), and other parties that conduct and manage various stages
+Added: of research and development activities on our behalf.
+Added: Fees for such services are recognized based on management’s estimates after
+Added: considering the activities and tasks completed by each service provider in a given period, the time period over which services are expected
+Added: to be performed, and the level of effort expended in each reporting period.
+Added: balance sheet date, management estimates prepaid and accrued research and development costs by discussing progress or stage of completion
+Added: of activities with internal personnel and external service providers, and comparing this information to payments made, invoices received,
+Added: and the agreed-upon contractual fee to be paid for such services in the applicable contract or statements of work.
+Added: we allocate certain internal compensation costs to research and development expenses based on management’s estimates of each employee’s
+Added: time and effort expended.
+Added: Investment Policy
+Added: The Company’s investment
+Added: policy is designed to optimize returns while managing risk and liquidity.
+Added: The policy allows for investments in a diversified range of
+Added: financial instruments, including U.S.
+Added: government debt securities with fixed maturities and contractual cash flows, as well as alternative
+Added: investments such as Bitcoin and Bitcoin-based exchange traded funds (collectively, the “Bitcoin Assets”).
+Added: The Company acquires U.S.
+Added: debt securities that it has the positive intent and ability to hold to maturity.
+Added: These securities are recorded at amortized cost, net
+Added: of any applicable discount which is amortized to interest income, and are accounted for as held-to-maturity securities.
+Added: The Company’s
+Added: Bitcoin Assets are measured at fair value based on quoted prices on active exchanges.
+Added: The Company recognizes changes in the fair value
+Added: of Bitcoin Assets as gains or losses in the statement of operations during the period in which they occur.
STOCK-BASED COMPENSATION
−Removed: Company maintains stock equity incentive plans under which the Company grants incentive stock options, non-qualified stock options, stock
−Removed: appreciation rights, stock awards, performance awards, or stock units to employees, directors and consultants.
−Removed: Option Compensation Expense
−Removed: account for stock options granted to employees, directors and others using the accounting guidance in ASC 718, Stock Compensation (“ASC
−Removed: We estimate the fair value of service-based stock options on the date of grant, using the Black-Scholes pricing model, and
−Removed: recognize compensation expense over the requisite service period of the grant.
−Removed: We recorded stock-based compensation expense related to
−Removed: service-based stock options granted to employees and directors of approximately $ 1,094,000 and $ 1,153,000 during the three months ended
−Removed: July 31, 2024 and 2023, respectively, and approximately $ 3,440,000 and $ 3,265,000 during the nine months ended July 31, 2024 and 2023,
−Removed: respectively.
−Removed: compensation cost for service-based stock options granted to consultants is measured at the grant date, based on the fair value of the
−Removed: award using the Black-Scholes pricing model, and is expensed on a straight-line basis over the requisite service period (the vesting
−Removed: period of the stock option) which is one to three years.
−Removed: We recorded stock-based consulting expense related to stock options granted
−Removed: to consultants of approximately $ 23,000 and $ 47,000 during the three months ended July 31, 2024 and 2023, respectively, and approximately
−Removed: $ 101,000 and $ 175,000 during the nine months ended July 31, 2024 and 2023, respectively.
−Removed: the three and nine months ended July 31, 2024, we had two stock option plans:
+Added: The Company maintains stock equity
+Added: incentive plans under which the Company may grant incentive stock options, non-qualified stock options, stock appreciation rights, stock
+Added: awards, performance awards, or stock units to employees, directors and consultants.
+Added: Stock Option Compensation Expense
+Added: We account for stock options granted
+Added: to employees, directors and consultants using the accounting guidance in ASC 718, Stock Compensation.
+Added: We estimate the fair value of service-based
+Added: stock options on the date of grant, using the Black-Scholes pricing model, and recognize compensation expense over the requisite service
+Added: period of the grant.
+Added: We recorded stock-based compensation expense related to service-based stock options granted to employees and directors
+Added: of approximately $ 1,031,000 and $ 1,108,000 during the three months ended January 31, 2025 and 2024.
+Added: The compensation cost for service-based
+Added: stock options granted to consultants is measured at the grant date, based on the fair value of the award using the Black-Scholes pricing
+Added: model, and is expensed on a straight-line basis over the requisite service period (the vesting period of the stock option) which is one
+Added: to three years.
+Added: We recorded stock-based consulting expense related to stock options granted to consultants of approximately $ 24,000 and
+Added: $ 56,000 during the three months ended January 31, 2025 and 2024, respectively.
+Added: Stock Option Activity
+Added: During the three months ended
+Added: January 31, 2025 and 2024, we granted options to purchase 1,355,000 shares and 1,335,000 shares of common stock, respectively, to employees
+Added: and consultants, with exercise prices ranging from $ 2.37 to $ 4.39 per share, pursuant to the 2018 Share Plan.
+Added: During the three months
+Added: ended January 31, 2025, no stock options were exercised.
+Added: During the three months ended January 31, 2024, stock options to purchase 24,000
+Added: shares of common stock were exercised on a cash basis, with aggregate proceeds of approximately $ 67,000 .
+Added: Stock Option Plans
+Added: During the three months ended
+Added: January 31, 2025, we had two stock option plans:
the Anixa Biosciences, Inc.
−Removed: 2010 Share Incentive Plan (the
−Removed: “2010 Share Plan”) and the Anixa Biosciences, Inc.
−Removed: 2018 Share Incentive Plan (the “2018 Share Plan”), which were
−Removed: adopted by our Board of Directors on July 14, 2010 and January 25, 2018, respectively.
−Removed: The 2018 Share Plan was approved by our shareholders
−Removed: on March 29, 2018.
−Removed: Option Activity
−Removed: the three months ended July 31, 2024 and 2023, we did not grant any options to purchase shares of common stock, and during the nine months
−Removed: ended July 31, 2024 and 2023, we granted options to purchase 1,350,000 shares and 1,505,000 shares of common stock, respectively, to
−Removed: employees, directors and consultants, with exercise prices ranging from $ 3.17 to $ 4.39 per share, pursuant to the 2018 Share Plan.
−Removed: the three months ended July 31, 2024, stock options to purchase 80,000 shares of common stock were exercised on a cash basis, with aggregate
−Removed: proceeds of approximately $ 194,000 .
−Removed: During the three months ended July 31, 2023, stock options to purchase 160,000 shares of common stock,
−Removed: of which 115,417 shares were withheld, were exercised on a cashless basis and stock options to purchase 10,446 shares of common stock
−Removed: were exercised on a cash basis, with aggregate proceeds of approximately $ 3,000 .
−Removed: During the nine months ended July 31, 2024, stock options
−Removed: to purchase 123,999 shares of common stock were exercised on a cash basis, with aggregate proceeds of approximately $ 318,000 .
−Removed: the nine months ended July 31, 2023, stock options to purchase 161,111 shares of common stock, of which 116,225 shares were withheld,
−Removed: were exercised on a cashless basis and stock options to purchase 39,525 shares of common stock were exercised on a cash basis, with aggregate
−Removed: proceeds of approximately $ 81,000 .
−Removed: 2010 Share Plan provided for the grant of nonqualified stock options, stock appreciation rights, stock awards, performance awards and
−Removed: stock units to employees, directors and consultants.
−Removed: In accordance with the provisions of the 2010 Share Plan, the plan terminated with
−Removed: respect to the ability to grant future awards on July 14, 2020.
−Removed: Information regarding the 2010 Share Plan for the nine months ended Jul
−Removed: 31, 2024 is as follows:
+Added: 2010 Share Incentive Plan (the “2010 Share Plan”)
+Added: and the Anixa Biosciences, Inc.
+Added: 2018 Share Incentive Plan (the “2018 Share Plan”), which were adopted by our Board of Directors
+Added: on July 14, 2010 and January 25, 2018, respectively.
+Added: The 2018 Share Plan was approved by our shareholders on March 29, 2018.
+Added: 2010 Share Plan
+Added: The 2010 Share Plan provided for
+Added: the grant of nonqualified stock options, stock appreciation rights, stock awards, performance awards and stock units to employees, directors
+Added: and consultants.
+Added: In accordance with the provisions of the 2010 Share Plan, the plan terminated with respect to the ability to grant future
+Added: awards on July 14, 2020.
+Added: Information regarding the 2010 Share Plan for the three months ended January 31, 2025 is as follows:
SCHEDULE OF OPTION ACTIVITY
−Removed: Exercise Price
+Added: Average Exercise
+Added: Price Per Share
Intrinsic Value
1 unchanged sentence
Options outstanding at October 31, 2024
−Removed: Options outstanding and exercisable at July 31, 2024
−Removed: following table summarizes information about stock options outstanding and exercisable under the 2010 Share Plan as of July 31, 2024:
+Added: Options outstanding and exercisable at January 31, 2025
+Added: The following table summarizes
+Added: information about stock options outstanding and exercisable under the 2010 Share Plan as of January 31, 2025:
OF OPTIONS OUTSTANDING AND EXERCISABLE
−Removed: Range of Exercise
+Added: Exercise Prices
Outstanding and
−Removed: Contractual Life
Weighted Average
+Added: Contractual Life
Exercise Price
2 unchanged sentences
3.46 - $ 5.30
−Removed: 2018 Share Plan provides for the grant of incentive stock options, nonqualified stock options, stock appreciation rights, stock awards,
−Removed: performance awards and stock units to employees, directors and consultants.
−Removed: As of July 31, 2024, the 2018 Share Plan had 938,907 shares
−Removed: available for future grants.
−Removed: Information regarding the 2018 Share Plan for the nine months ended July 31, 2024 is as follows:
+Added: 2018 Share Plan
+Added: The 2018 Share Plan provides for
+Added: the grant of incentive stock options, nonqualified stock options, stock appreciation rights, stock awards, performance awards and stock
+Added: units to employees, directors and consultants.
+Added: As of January 31, 2025, the 2018 Share Plan had 645,000 shares available for future grants.
+Added: Information regarding the 2018 Share Plan for the three months ended January 31, 2025 is as follows:
OF OPTION ACTIVITY
−Removed: Exercise Price
+Added: Average Exercise
+Added: Price Per Share
Intrinsic Value
1 unchanged sentence
Options outstanding at October 31, 2024
−Removed: Options outstanding at July 31, 2024
−Removed: Options exercisable at July 31, 2024
−Removed: following table summarizes information about stock options outstanding and exercisable under the 2018 Share Plan as of July 31, 2024:
+Added: Forfeited/expired
+Added: Options outstanding at January 31, 2025
+Added: Options exercisable at January 31, 2025
+Added: The following table summarizes
+Added: information about stock options outstanding and exercisable under the 2018 Share Plan as of January 31, 2025:
OF OPTIONS OUTSTANDING AND EXERCISABLE
2 unchanged sentences
Exercise Prices
−Removed: Remaining Contractual
+Added: Contractual Life
Exercise Price
+Added: Contractual Life
Exercise Price
2.09 - $ 3.87
−Removed: Stock Purchase Plan
−Removed: Company maintains the Anixa Biosciences, Inc.
−Removed: Employee Stock Purchase Plan (the “ESPP”) which permits eligible employees
−Removed: to purchase shares at not less than 85 % of the market value of the Company’s common stock on the offering date or the purchase
−Removed: date of the applicable offering period, whichever is lower.
−Removed: The ESPP was adopted by our Board of Directors on August 13, 2018 and approved
−Removed: by our shareholders on September 27, 2018.
−Removed: During the three and nine months ended July 31, 2024 and 2023, employees purchased 2,616 and
−Removed: 1,903 shares, respectively, with aggregate proceeds of approximately $ 7,000 and $ 6,000 , respectively.
−Removed: of July 31, 2024, we had warrants outstanding to purchase 300,000 shares of common stock at $ 6.56 per share, issued during fiscal year
−Removed: 2021 and expiring on March 22, 2026.
−Removed: regarding the Company’s warrants for the nine months ended July 31, 2024 is as follows:
+Added: 4.02 - $ 5.30
+Added: Employee Stock Purchase Plan
+Added: The Company maintains the Anixa
+Added: Biosciences, Inc.
+Added: Employee Stock Purchase Plan (the “ESPP”) which permits eligible employees to purchase shares at not less
+Added: than 85 % of the market value of the Company’s common stock on the offering date or the purchase date of the applicable offering
+Added: period, whichever is lower.
+Added: The ESPP was adopted by our Board of Directors on August 13, 2018 and approved by our shareholders on September
+Added: During the three months ended January 31, 2025 and 2024, no shares were purchased under the ESPP.
+Added: As of January 31, 2025, we had
+Added: warrants outstanding to purchase 300,000 shares of common stock at $ 6.56 per share, issued during fiscal year 2021 and expiring on March
+Added: Information regarding the Company’s
+Added: warrants for the three months ended January 31, 2025 is as follows:
OF WARRANTS ACTIVITY
−Removed: Exercise Price
−Removed: Intrinsic Value
+Added: Average Exercise
+Added: Price Per Share
Warrants outstanding at October 31, 2024
−Removed: Warrants outstanding and exercisable at July 31, 2024
−Removed: following table summarizes information about the Company’s outstanding and exercisable warrants as of July 31, 2024:
−Removed: OF OUTSTANDING AND EXERCISABLE
−Removed: Range of Exercise
+Added: Warrants outstanding and exercisable at January 31, 2025
+Added: The following table summarizes
+Added: information about the Company’s outstanding and exercisable warrants as of January 31, 2025:
+Added: SCHEDULE OF OUTSTANDING AND EXERCISABLE
+Added: Exercise Prices
Outstanding and
−Removed: Contractual Life
Weighted Average
+Added: Contractual Life
Exercise Price
−Removed: the three months ended July 31, 2024 and 2023, we issued 60,000 shares and 4,076 shares of common stock, respectively, to consultants
−Removed: providing investor relations services and recorded expense of approximately $ 62,000 and $ 17,000 , respectively.
−Removed: During the nine months
−Removed: ended July 31, 2024 and 2023, we issued 89,336 shares and 17,554 shares of common stock, respectively, to consultants providing investor
−Removed: relations services and recorded expense of approximately $ 158,000 and $ 67,000 , respectively.
−Removed: As of July 31, 2024 and 2023, approximately
−Removed: $ 97,000 and $ 0 , respectively, was recorded as a prepaid expense.
+Added: During the three months ended
+Added: January 31, 2025, we did not issue any stock awards.
+Added: During the three months ended January 31, 2024, we issued 29,336 shares of common
+Added: stock to consultants providing investor relations services, and recorded expense of approximately $ 96,000 .
+Added: Treasury stock
+Added: As of January 31, 2025, the Company
+Added: held 2,000 shares of its common stock as treasury stock.
+Added: These shares were repurchased during the fiscal year ended October 31, 2024,
+Added: at an average cost of $ 3.17 per share for a total cost of approximately $ 6,000 .
+Added: The repurchases were made as part of a stock buyback program
+Added: approved by our Board of Directors on July 11, 2024.
+Added: The treasury shares are accounted for under the cost method and are recorded as a
+Added: reduction in shareholders’ equity in the consolidated balance sheet.
+Added: The Company may reissue treasury shares for stock option exercises,
+Added: acquisitions, or other corporate purposes.
FAIR VALUE MEASUREMENTS
−Removed: GAAP defines fair value and establishes a framework for measuring fair value.
−Removed: We have categorized our financial assets and liabilities,
−Removed: based on the priority of the inputs to the valuation technique, into a three-level fair value hierarchy as set forth below.
−Removed: If the inputs
−Removed: used to measure the financial instruments fall within different levels of the hierarchy, the categorization is based on the lowest level
−Removed: input that is significant to the fair value measurement of the instrument.
−Removed: assets and liabilities recorded in the accompanying condensed consolidated balance sheets are categorized based on the inputs to the
−Removed: valuation techniques as follows:
−Removed: 1 – Financial instruments whose values are based on unadjusted quoted prices for identical assets or liabilities in an active market
−Removed: which we have the ability to access at the measurement date.
−Removed: 2 – Financial instruments whose values are based on quoted market prices in markets where trading occurs infrequently or whose
−Removed: values are based on quoted prices of instruments with similar attributes in active markets.
−Removed: 3 – Financial instruments whose values are based on prices or valuation techniques that require inputs that are both unobservable
−Removed: and significant to the overall fair value measurement.
−Removed: These inputs reflect management’s own assumptions about the assumptions
−Removed: a market participant would use in pricing the instrument.
−Removed: following table presents the hierarchy for our financial assets measured at fair value on a recurring basis as of July 31, 2024 (in thousands):
+Added: US GAAP defines fair value and
+Added: establishes a framework for measuring fair value.
+Added: We have categorized our financial assets and liabilities, based on the priority of the
+Added: inputs to the valuation technique, into a three-level fair value hierarchy as set forth below.
+Added: If the inputs used to measure the financial
+Added: instruments fall within different levels of the hierarchy, the categorization is based on the lowest level input that is significant to
+Added: the fair value measurement of the instrument.
+Added: Financial assets and liabilities
+Added: recorded in the accompanying condensed consolidated balance sheets are categorized based on the inputs to the valuation techniques as
+Added: Level 1 – Financial instruments
+Added: whose values are based on unadjusted quoted prices for identical assets or liabilities in an active market which we have the ability to
+Added: access at the measurement date.
+Added: Level 2 – Financial instruments
+Added: whose values are based on quoted market prices in markets where trading occurs infrequently or whose values are based on quoted prices
+Added: of instruments with similar attributes in active markets.
+Added: Level 3 – Financial instruments
+Added: whose values are based on prices or valuation techniques that require inputs that are both unobservable and significant to the overall
+Added: fair value measurement.
+Added: These inputs reflect management’s own assumptions about the assumptions a market participant would use in
+Added: pricing the instrument.
+Added: The following table presents the
+Added: hierarchy for our financial assets measured at fair value on a recurring basis as of January 31, 2025 (in thousands):
SCHEDULE OF FINANCIAL ASSETS MEASURED AT FAIR VALUE ON A RECURRING BASIS
1 unchanged sentence
Cash equivalents
+Added: Bitcoin exchange traded funds:
+Added: Short-term investments
treasury bills:
1 unchanged sentence
Total financial assets
−Removed: following table presents the hierarchy for our financial assets measured at fair value on a recurring basis as of October 31, 2023 (in
+Added: The following table presents the
+Added: hierarchy for our financial assets measured at fair value on a recurring basis as of October 31, 2024 (in thousands):
Money market funds:
Cash equivalents
−Removed: Certificates of deposit:
−Removed: Short term investments
treasury bills:
1 unchanged sentence
Total financial assets
−Removed: non-financial assets that are measured on a non-recurring basis are property and equipment and other assets which are measured using
−Removed: fair value techniques whenever events or changes in circumstances indicate a condition of impairment exists.
−Removed: The estimated fair value
−Removed: of prepaid expenses and other current assets, accounts payable and accrued expenses approximates their individual carrying amounts due
−Removed: to the short-term nature of these measurements.
+Added: Our non-financial assets that
+Added: are measured at fair value on a non-recurring basis are property and equipment and other assets which are measured using fair value techniques
+Added: whenever events or changes in circumstances indicate a condition of impairment exists.
+Added: The estimated fair value of prepaid expenses and
+Added: other current assets, accounts payable and accrued expenses approximates their individual carrying amounts due to the short-term nature
+Added: of these measurements.
Cash equivalents are stated at carrying value which approximates fair value.
ACCRUED EXPENSES
−Removed: expenses consist of the following as of:
+Added: Accrued expenses consist of the
+Added: following as of:
SCHEDULE OF ACCRUED EXPENSES
5 unchanged sentences
NET LOSS PER SHARE OF COMMON STOCK
−Removed: net loss per common share (“Basic EPS”) is computed by dividing net loss by the weighted average number of common shares
−Removed: Diluted net loss per common share (“Diluted EPS”) is computed by dividing net loss by the weighted average number
−Removed: of common shares and dilutive common share equivalents and convertible securities then outstanding.
−Removed: Diluted EPS for all periods presented
−Removed: is the same as Basic EPS, as the inclusion of the effect of common share equivalents then outstanding would be anti-dilutive.
−Removed: reason, excluded from the calculation of Diluted EPS for the nine months ended July 31, 2024 and 2023, were stock options to purchase
−Removed: 12,342,094 and 11,473,236 shares, respectively, and warrants to purchase 300,000 and 300,000 shares, respectively.
+Added: Basic net loss per common share
+Added: (“Basic EPS”) is computed by dividing net loss by the weighted average number of common shares outstanding.
+Added: Diluted net loss
+Added: per common share (“Diluted EPS”) is computed by dividing net loss by the weighted average number of common shares and dilutive
+Added: common share equivalents and convertible securities then outstanding.
+Added: Diluted EPS for all periods presented is the same as Basic EPS,
+Added: as the inclusion of the effect of common share equivalents then outstanding would be anti-dilutive.
+Added: For this reason, excluded from the
+Added: calculation of Diluted EPS for the three months ended January 31, 2025 and 2024, were stock options to purchase 13,488,062 and 12,497,094
+Added: shares, respectively, and warrants to purchase 300,000 and 300,000 shares, respectively.
EFFECT OF RECENTLY ADOPTED AND ISSUED PRONOUNCEMENTS
−Removed: October 2021, the FASB issued Accounting Standards Update 2021-08, Business Combinations (Topic 805):
−Removed: Accounting for Contract Assets
−Removed: and Contract Liabilities from Contracts with Customers, to require that an acquirer recognize and measure contract assets and contract
−Removed: liabilities acquired in a business combination in accordance with Topic 606, Revenue from Contracts with Customers.
−Removed: At the acquisition
−Removed: date, an acquirer should account for the related revenue contracts in accordance with Topic 606 as if it had originated the contracts.
−Removed: The amendments in this update should be applied prospectively and are effective for fiscal years beginning after December 15, 2022, including
−Removed: interim periods within those fiscal years.
−Removed: The adoption of this standard did not have a material impact on our consolidated financial
−Removed: statements and related disclosures.
−Removed: November 2023, the FASB issued Accounting Standards Update 2023-07, Segment Reporting (Topic 280):
−Removed: Improvements to Reportable
−Removed: Segment Disclosures, to provide more disaggregated expense information about a public entity’s reportable segments.
−Removed: amendments in this update should be applied retrospectively and are effective for fiscal years beginning after December 15, 2023,
−Removed: and interim periods beginning after December 15, 2024.
−Removed: We began a detailed assessment of the impact that this guidance will have on
−Removed: our consolidated financial statements and related disclosures, and our analysis is currently ongoing.
−Removed: December 2023, the FASB issued Accounting Standards Update 2023-09, Income Taxes (Topic 740):
−Removed: Improvements to Income Tax
−Removed: Disclosures, to require disaggregated information about a reporting entity’s effect tax rate reconciliation as well as
−Removed: information on income taxes paid.
−Removed: The amendments in this update should be applied prospectively, with an option to apply them
−Removed: retrospectively, and are effective for fiscal years beginning after December 15, 2024 for public entities.
−Removed: We began a detailed
−Removed: assessment of the impact that this guidance will have on our consolidated financial statements and related disclosures, and our analysis is currently ongoing.
−Removed: recognize deferred tax assets and liabilities for the estimated future tax effects of events that have been recognized in our financial
−Removed: statements or tax returns.
−Removed: Under this method, deferred tax assets and liabilities are determined based on the difference between the
−Removed: financial statement and tax bases of assets and liabilities using enacted tax rates in effect in the years in which the differences are
−Removed: expected to reverse.
−Removed: A valuation allowance is established, when necessary, to reduce deferred tax assets to the amount expected to be
−Removed: We have provided a full valuation allowance against our deferred tax asset due to our historical pre-tax losses and the uncertainty
−Removed: regarding the realizability of these deferred tax assets.
−Removed: have substantial net operating loss carryforwards for Federal and California income tax returns.
−Removed: These net operating loss carryforwards
−Removed: could be subject to limitations under Internal Revenue Code section 382, the effects of which have not been determined by the Company.
−Removed: We have no unrecognized income tax benefits as of July 31, 2024 and October 31, 2023 and we account for interest and penalties related
−Removed: to income tax matters, if any, in general and administrative expenses.
−Removed: lease approximately 2,000 square feet of office space at 3150 Almaden Expressway, San Jose, California (our principal executive offices)
−Removed: from an unrelated party pursuant to an operating lease that, as amended, will expire on September 30, 2027 , with an option to extend
−Removed: the lease an additional two years .
−Removed: Our base rent is approximately $ 5,000 per month and the lease provides for annual increases of approximately
−Removed: 3 % and an escalation clause for increases in certain operating costs.
−Removed: The lease, as amended, resulted in a right-of-use asset and lease
−Removed: liability of approximately $ 250,000 with a discount rate of 12 %.
−Removed: Rent expense was approximately $ 16,000 and $ 17,000 , respectively, for
−Removed: the three months ended July 31, 2024 and 2023, and approximately $ 49,000 and $ 50,000 , respectively, for the nine months ended July 31,
+Added: In November 2023, the FASB issued
+Added: Accounting Standards Update 2023-07, Segment Reporting (Topic 280):
+Added: Improvements to Reportable Segment Disclosures, to provide more disaggregated
+Added: expense information about a public entity’s reportable segments.
+Added: The amendments in this update should be applied retrospectively
+Added: and are effective for fiscal years beginning after December 15, 2023, and interim periods beginning after December 15, 2024.
+Added: a detailed assessment of the impact that this guidance will have on our consolidated financial statements and related disclosures, and
+Added: our analysis is currently ongoing.
+Added: In December 2023, the FASB issued
+Added: Accounting Standards Update 2023-09, Income Taxes (Topic 740):
+Added: Improvements to Income Tax Disclosures, to require disaggregated information
+Added: about a reporting entity’s effective tax rate reconciliation as well as information on income taxes paid.
+Added: The amendments in this
+Added: update should be applied prospectively, with an option to apply them retrospectively, and are effective for fiscal years beginning after
+Added: December 15, 2024 for public entities.
+Added: We began a detailed assessment of the impact that this guidance will have on our consolidated financial
+Added: statements and related disclosures, and our analysis is currently ongoing.
+Added: In March 2024, the FASB issued
+Added: Accounting Standards Update 2024-03, Income Statement—Reporting Comprehensive Income—Expense Disaggregation Disclosures (Subtopic
+Added: Disaggregation of Income Statement Expenses, to improve the disclosures about a public business entity’s expenses and to
+Added: provide more detailed information about the types of expenses in commonly presented expense captions.
+Added: The amendments in this update should
+Added: be applied either prospectively or retrospectively, and are effective for fiscal years beginning after December 15, 2026, and interim
+Added: periods beginning after December 15, 2027.
+Added: We began a detailed assessment of the impact that this guidance will have on our consolidated
+Added: financial statements and related disclosures, and our analysis is currently ongoing.
+Added: We recognize deferred tax assets
+Added: and liabilities for the estimated future tax effects of events that have been recognized in our financial statements or tax returns.
+Added: this method, deferred tax assets and liabilities are determined based on the difference between the financial statement and tax bases
+Added: of assets and liabilities using enacted tax rates in effect in the years in which the differences are expected to reverse.
+Added: allowance is established, when necessary, to reduce deferred tax assets to the amount expected to be realized.
+Added: We have provided a full
+Added: valuation allowance against our deferred tax asset due to our historical pre-tax losses and the uncertainty regarding the realizability
+Added: of these deferred tax assets.
+Added: We have substantial net operating
+Added: loss carryforwards for Federal and California income tax returns.
+Added: These net operating loss carryforwards could be subject to limitations
+Added: under Internal Revenue Code section 382, the effects of which have not been determined by the Company.
+Added: We have no unrecognized income
+Added: tax benefits as of January 31, 2025 and October 31, 2024 and we account for interest and penalties related to income tax matters, if any,
+Added: in general and administrative expenses.
+Added: We lease approximately 2,000 square
+Added: feet of office space at 3150 Almaden Expressway, San Jose, California (our principal executive offices) from an unrelated party pursuant
+Added: to an operating lease that, as amended, will expire on September 30, 2027 , with an option to extend the lease an additional two years.
+Added: The base rent is approximately $ 5,000 per month and the lease provides for annual increases of approximately 3 % and an escalation clause
+Added: for increases in certain operating costs.
+Added: The lease, as amended, resulted in a right-of-use asset and lease liability of approximately
+Added: $ 250,000 with a discount rate of 12 %.
+Added: Rent expense was approximately $ 16,000 and $ 17,000 , respectively, for the three months ended January
31, 2025 and 2024.
−Removed: operating leases, the lease liability is initially and subsequently measured at the present value of the unpaid lease payments.
−Removed: The remaining
−Removed: 62 -month lease term as of July 31, 2024 for the Company’s lease includes the noncancelable period of the lease and the additional
−Removed: two-year option period that the Company is reasonably certain to exercise.
−Removed: All right-of-use assets are reviewed for impairment when indications
−Removed: of impairment are present.
−Removed: of July 31, 2024, the annual minimum future lease payments of our operating lease liabilities were as follows (in thousands):
+Added: For operating leases, the lease
+Added: liability is initially and subsequently measured at the present value of the unpaid lease payments.
+Added: The remaining 56 -month lease term
+Added: as of January 31, 2025 for the Company’s lease includes the noncancelable period of the lease and the additional two-year option
+Added: period that the Company is reasonably certain to exercise.
+Added: All right-of-use assets are reviewed for impairment when indications of impairment
+Added: As of January 31, 2025, the annual
+Added: minimum future lease payments of our operating lease liability were as follows (in thousands):
SCHEDULE OF MINIMUM LEASE PAYMENTS
4 unchanged sentences
Present value of future minimum lease payments
+Added: Balance as of January 31, 2025:
+Added: Operating lease liability
+Added: Operating lease liability, non-current
COMMITMENTS AND CONTINGENCES
−Removed: than lawsuits related to the enforcement of our patent rights, we are not a party to any material pending legal proceedings, nor are
−Removed: we aware of any pending litigation or legal proceeding against us that would have a material adverse effect upon our results of operations
−Removed: or financial condition.
−Removed: of July 31, 2024, our commitments under certain technology license agreements related to our therapeutic and vaccine development programs
−Removed: for the next twelve months, were approximately $ 150,000 .
−Removed: & Development Agreements
−Removed: have entered into certain research and development agreements with various third-party vendors related to the manufacturing and stability
−Removed: testing of the materials necessary for the development of our breast cancer vaccine and our CAR-T therapeutic, as well as basic research
−Removed: related to our new cancer vaccine discovery program.
−Removed: As of July 31, 2024, future payments the Company may make under these agreements,
−Removed: dependent upon, among other things, development of analytical methods, formulation feasibility studies, stability testing, and results
−Removed: of manufacturing processes, may be approximately $ 4.3 million and such payments may be made over up to a five -year period.
+Added: Litigation Matters
+Added: Other than lawsuits related to
+Added: the enforcement of our patent rights, we are not a party to any material pending legal proceedings, nor are we aware of any pending litigation
+Added: or legal proceeding against us that would have a material adverse effect upon our results of operations or financial condition.
+Added: License Commitments
+Added: As of January 31, 2025, our commitments
+Added: under certain technology license agreements related to our therapeutic and vaccine development programs for the next twelve months, were
+Added: approximately $ 150,000 .
+Added: Research & Development Agreements
+Added: We have entered into certain research
+Added: and development agreements with various collaboration partners and third-party vendors related to i) the manufacturing of materials necessary
+Added: for the expected Phase 2 clinical trial of our breast cancer vaccine, ii) the discovery of new vaccine targets in high incidence malignancies
+Added: in prostate, lung and colon and iii) the further development of our CAR-T technology.
+Added: As of January 31, 2025, future payments the Company
+Added: may make under these agreements, dependent upon, among other things, development of analytical methods, formulation feasibility studies,
+Added: stability testing and results of manufacturing processes, may be approximately $ 3.7 million and such payments may be made over up to a
+Added: five-year period.
SEGMENT INFORMATION
−Removed: follow the accounting guidance of ASC 280 “Segment Reporting” (“ASC 280”).
−Removed: Reportable operating segments are
−Removed: determined based on the management approach.
−Removed: The management approach, as defined by ASC 280, is based on the way that the chief operating
−Removed: decision-maker organizes the segments within an enterprise for making operating decisions and assessing performance.
−Removed: While our results
−Removed: of operations are primarily reviewed on a consolidated basis, the chief operating decision-maker manages the enterprise in three reportable
−Removed: segments, each with different operating and potential revenue generating characteristics:
−Removed: (i) CAR-T Therapeutics, (ii) Cancer Vaccines
−Removed: and (iii) Other.
−Removed: The following represents selected financial information for our segments for the three and nine months ended July 31,
−Removed: 2024 and 2023 and as of July 31, 2024 and October 31, 2023, in thousands:
+Added: We follow the accounting guidance
+Added: of ASC 280 “Segment Reporting” (“ASC 280”).
+Added: Reportable operating segments are determined based on the management
+Added: The management approach, as defined by ASC 280, is based on the way that the chief operating decision-maker organizes the segments
+Added: within an enterprise for making operating decisions and assessing performance.
+Added: While our results of operations are primarily reviewed
+Added: on a consolidated basis, the chief operating decision-maker manages the enterprise in three reportable segments, each with different operating and potential revenue generating
+Added: characteristics:
+Added: (i) Cancer Vaccines, (ii) CAR-T Therapeutics, and (iii) Other.
+Added: The following represents selected financial information
+Added: for our segments for the three months ended January 31, 2025 and 2024 and as of January 31, 2025 and October 31, 2024 (in thousands):
SCHEDULE OF SEGMENT INFORMATION
For the Three Months Ended
−Removed: For the Nine Months Ended
−Removed: CAR-T Therapeutics
Cancer Vaccines
+Added: CAR-T Therapeutics
Net income (loss)
2 unchanged sentences
Operating costs and expenses excluding non-cash stock-based compensation
−Removed: Operating costs and expenses excluding non-cash stock-based compensation:
−Removed: CAR-T Therapeutics
+Added: Operating costs and expenses excluding non-cash stock-based compensation expense:
Cancer Vaccines
−Removed: costs and expenses excluding non-cash stock-based compensation
−Removed: Total assets:
CAR-T Therapeutics
+Added: Operating costs and expenses excluding non-cash share based compensation
+Added: Total assets:
Cancer Vaccines
−Removed: costs and expenses excluding non-cash stock-based compensation is the measurement the chief operating decision-maker uses in managing
−Removed: the enterprise.
−Removed: Company’s consolidated revenue of $ 210,000 and inventor royalties, contingent legal fees, litigation and licensing expense of $ 161,000
−Removed: for the nine months ended July 31, 2023 were solely related to our encrypted audio/video conference calling technology, which is included
−Removed: in our Other segment.
−Removed: All our revenue is generated domestically (United States) based on the country in which the licensee is located.
+Added: CAR-T Therapeutics
+Added: Operating costs and expenses excluding
+Added: non-cash stock-based compensation is the measurement the chief operating decision-maker uses in managing the enterprise.
Compared sentence by sentence after normalising whitespace, quotation marks, case and digits, so re-formatting and restated figures do not read as changed language. Wording changes appear as one removal and one addition. The current filing and the prior one are authoritative.