Controls and Procedures
−Removed: Controls and Procedures
−Removed: maintain disclosure controls and procedures, as such term is defined in Rules 13a-15(e) and 15d-15(e) under the Exchange Act.
−Removed: supervision and with the participation of our management, including our Chief Executive Officer and our Chief Financial Officer, we evaluated
−Removed: the effectiveness of the design and operation of our disclosure controls and procedures pursuant to Rule 13a-15 and 15d-15 of the Exchange
−Removed: Based upon that evaluation, our Chief Executive Officer and our Chief Financial Officer concluded that our disclosure controls and
−Removed: procedures were effective as of the end of fiscal year 2023.
−Removed: Report on Internal Control Over Financial Reporting
−Removed: management is responsible for establishing and maintaining adequate internal control over financial reporting as such term is defined
−Removed: in Rules 13a-15(f) and 15d-15(f) of the Exchange Act.
−Removed: Our management, including the principal executive officer and principal financial
−Removed: officer, does not expect that our internal controls over financial reporting will prevent all errors and all fraud.
−Removed: A control system,
−Removed: no matter how well designed and operated, cannot provide full assurance that the objectives of the control system are met, and no evaluation
−Removed: of controls can provide absolute assurance that all control issues and instances of fraud, if any, within a company have been detected.
−Removed: Our internal control over financial reporting is designed to provide reasonable assurance regarding the reliability of financial reporting
−Removed: and the preparation of consolidated financial statements for external purposes in accordance with generally accepted accounting principles.
−Removed: the supervision and with the participation of our management, including the principal executive officer and principal financial officer,
−Removed: we conducted an evaluation as to the effectiveness of our internal control over financial reporting as of October 31, 2023.
−Removed: this assessment, our management used the criteria for effective internal control set forth by the Committee of Sponsoring Organizations
−Removed: of the Treadway Commission in the 2013 Internal Control – Integrated Framework .
−Removed: Based on this assessment, our management
−Removed: concluded that our internal control over financial reporting was effective as of October 31, 2023.
−Removed: Annual Report on Form 10-K does not include an attestation report of our independent registered public accounting firm regarding internal
−Removed: control over financial reporting.
−Removed: Management’s report was not subject to attestation by the Company’s independent registered
−Removed: public accounting firm pursuant to an exemption of the Commission that permits smaller reporting companies and non-accelerated filers,
−Removed: such as the Company, to provide only management’s report in this Annual Report on Form 10-K.
−Removed: Accordingly, our management’s
−Removed: assessment of the effectiveness of our internal control over financial reporting as of October 31, 2023 has not been audited by our auditors,
−Removed: Haskell & White LLP.
−Removed: in Internal Control Over Financial Reporting
−Removed: were no changes in our internal control over financial reporting during the fourth quarter of fiscal year 2023 that has materially affected,
−Removed: or is reasonably likely to materially affect, the Company’s internal control over financial reporting.
+Added: Disclosure Controls and Procedures
+Added: We maintain disclosure controls
+Added: and procedures, as such term is defined in Rules 13a-15(e) and 15d-15(e) under the Exchange Act.
+Added: Under the supervision and with the participation
+Added: of our management, including our Chief Executive Officer and our Chief Financial Officer, we evaluated the effectiveness of the design
+Added: and operation of our disclosure controls and procedures pursuant to Rule 13a-15 and 15d-15 of the Exchange Act.
+Added: Based upon that evaluation,
+Added: our Chief Executive Officer and our Chief Financial Officer concluded that our disclosure controls and procedures were effective as of
+Added: the end of fiscal year 2024.
+Added: Management’s Report on
+Added: Internal Control Over Financial Reporting
+Added: Our management is responsible
+Added: for establishing and maintaining adequate internal control over financial reporting as such term is defined in Rules 13a-15(f) and 15d-15(f)
+Added: of the Exchange Act.
+Added: Our management, including the principal executive officer and principal financial officer, does not expect that our
+Added: internal controls over financial reporting will prevent all errors and all fraud.
+Added: A control system, no matter how well designed and operated,
+Added: cannot provide full assurance that the objectives of the control system are met, and no evaluation of controls can provide absolute assurance
+Added: that all control issues and instances of fraud, if any, within a company have been detected.
+Added: Our internal control over financial reporting
+Added: is designed to provide reasonable assurance regarding the reliability of financial reporting and the preparation of consolidated financial
+Added: statements for external purposes in accordance with generally accepted accounting principles.
+Added: Under the supervision and with
+Added: the participation of our management, including the principal executive officer and principal financial officer, we conducted an evaluation
+Added: as to the effectiveness of our internal control over financial reporting as of October 31, 2024.
+Added: In making this assessment, our management
+Added: used the criteria for effective internal control set forth by the Committee of Sponsoring Organizations of the Treadway Commission in
+Added: the 2013 Internal Control – Integrated Framework .
+Added: Based on this assessment, our management concluded that our internal control
+Added: over financial reporting was effective as of October 31, 2024.
+Added: This Annual Report on Form 10-K
+Added: does not include an attestation report of our independent registered public accounting firm regarding internal control over financial
+Added: Management’s report was not subject to attestation by the Company’s independent registered public accounting firm
+Added: pursuant to an exemption of the Commission that permits smaller reporting companies and non-accelerated filers, such as the Company, to
+Added: provide only management’s report in this Annual Report on Form 10-K.
+Added: Accordingly, our management’s assessment of the effectiveness
+Added: of our internal control over financial reporting as of October 31, 2024 has not been audited by our auditors, Haskell & White LLP.
+Added: Changes in Internal Control Over Financial Reporting
+Added: There were no changes in our internal
+Added: control over financial reporting during the fourth quarter of fiscal year 2024 that has materially affected, or is reasonably likely to
+Added: materially affect, the Company’s internal control over financial reporting.
Other Information
−Removed: Directors, Executive Officers and Corporate Governance.
−Removed: information required by this Item will be set forth in our Proxy Statement for the 2024 Annual Meeting of Stockholders scheduled for
−Removed: March 21, 2024 which such Proxy Statement will be filed with the SEC within 120 days of October 31, 2023, and will be incorporated into
−Removed: this Annual Report on Form 10-K by reference.
+Added: Directors, Executive Officers and Corporate
+Added: The information required by this
+Added: Item will be set forth in our Proxy Statement for the 2025 Annual Meeting of Stockholders scheduled for March 20, 2025 which such Proxy
+Added: Statement will be filed with the SEC within 120 days of October 31, 2024, and will be incorporated into this Annual Report on Form 10-K
+Added: by reference.
Executive Compensation
−Removed: information required by this Item will be set forth in our Proxy Statement for the 2024 Annual Meeting of Stockholders scheduled for
−Removed: March 21, 2024 which such Proxy Statement will be filed with the SEC within 120 days of October 31, 2023, and will be incorporated into
−Removed: this Annual Report on Form 10-K by reference.
−Removed: Security Ownership of Certain Beneficial Owners and Management and Related Stockholder Matters.
−Removed: information required by this Item will be set forth in our Proxy Statement for the 2024 Annual Meeting of Stockholders scheduled for
−Removed: March 21, 2024 which such Proxy Statement will be filed with the SEC within 120 days of October 31, 2023, and will be incorporated into
−Removed: this Annual Report on Form 10-K by reference.
−Removed: Certain Relationships and Related Transactions, and Director Independence.
−Removed: information required by this Item will be set forth in our Proxy Statement for the 2024 Annual Meeting of Stockholders scheduled for
−Removed: March 21, 2024 which such Proxy Statement will be filed with the SEC within 120 days of October 31, 2023, and will be incorporated into
−Removed: this Annual Report on Form 10-K by reference.
+Added: The information required by this
+Added: Item will be set forth in our Proxy Statement for the 2025 Annual Meeting of Stockholders scheduled for March 20, 2025 which such Proxy
+Added: Statement will be filed with the SEC within 120 days of October 31, 2024, and will be incorporated into this Annual Report on Form 10-K
+Added: by reference.
+Added: Security Ownership of Certain Beneficial
+Added: Owners and Management and Related Stockholder Matters
+Added: The information required by this
+Added: Item will be set forth in our Proxy Statement for the 2025 Annual Meeting of Stockholders scheduled for March 20, 2025 which such Proxy
+Added: Statement will be filed with the SEC within 120 days of October 31, 2024, and will be incorporated into this Annual Report on Form 10-K
+Added: by reference.
+Added: Certain Relationships and Related Transactions,
+Added: and Director Independence
+Added: The information required by this
+Added: Item will be set forth in our Proxy Statement for the 2025 Annual Meeting of Stockholders scheduled for March 20, 2025 which such Proxy
+Added: Statement will be filed with the SEC within 120 days of October 31, 2024, and will be incorporated into this Annual Report on Form 10-K
+Added: by reference.
Principal Accounting Fees and Services
−Removed: information required by this Item will be set forth in our Proxy Statement for the 2024 Annual Meeting of Stockholders scheduled for
−Removed: March 21, 2024 which such Proxy Statement will be filed with the SEC within 120 days of October 31, 2023, and will be incorporated into
−Removed: this Annual Report on Form 10-K by reference.
+Added: The information required by this
+Added: Item will be set forth in our Proxy Statement for the 2025 Annual Meeting of Stockholders scheduled for March 20, 2025 which such Proxy
+Added: Statement will be filed with the SEC within 120 days of October 31, 2024, and will be incorporated into this Annual Report on Form 10-K
+Added: by reference.
Exhibits, Financial Statement Schedules
−Removed: Financial Statement Schedules
−Removed: accompanying “Index to Consolidated Financial Statements.”
−Removed: of Incorporation, as amended.
−Removed: (Incorporated by reference to Form 10-Q for the fiscal quarter ended July 31, 1992 and Form S-3, dated
−Removed: February 11, 2014.)
−Removed: to the Certificate of Incorporation.
+Added: (a)(1)(2) Financial
+Added: Statement Schedules
+Added: See accompanying “Index
+Added: to Consolidated Financial Statements.”
+Added: Certificate of Incorporation, as amended.
+Added: (Incorporated by reference to Form 10-Q for the fiscal quarter ended July 31, 1992 and Form S-3, dated February 11, 2014.)
+Added: Amendment to the Certificate of Incorporation.
(Incorporated by reference to Exhibit 3.2 to our Form 10-K for the fiscal year ended October 31, 2013.)
−Removed: of Amendment to the Certificate of Incorporation.
+Added: Certificate of Amendment to the Certificate of Incorporation.
(Incorporated by reference to Exhibit 3.1 to our Form 8-K, dated September 4, 2014.)
−Removed: of Designations, Preferences and Rights of Series A Convertible Preferred Stock.
−Removed: (Incorporated by reference to Exhibit 3.1 to our
−Removed: Form 8-K, dated September 10, 2014.)
−Removed: of Amendment to the Certificate of Incorporation.
+Added: Certificate of Designations, Preferences and Rights of Series A Convertible Preferred Stock.
+Added: (Incorporated by reference to Exhibit 3.1 to our Form 8-K, dated September 10, 2014.)
+Added: Certificate of Amendment to the Certificate of Incorporation.
(Incorporated by reference to Exhibit 3.1 to our Form 8-K, dated June 25, 2015.)
−Removed: of Amendment to the Certificate of Incorporation.
−Removed: (Incorporated by reference to Exhibit 3.1 to our Form 10-Q for the fiscal quarter
−Removed: ended April 30, 2018.)
−Removed: of Amendment to the Certificate of Incorporation.
+Added: Certificate of Amendment to the Certificate of Incorporation.
+Added: (Incorporated by reference to Exhibit 3.1 to our Form 10-Q for the fiscal quarter ended April 30, 2018.)
+Added: Certificate of Amendment to the Certificate of Incorporation.
(Incorporated by reference to Exhibit 3.1 to our Form 8-K, dated October 1, 2018.)
−Removed: of Amendment to the Certificate of Incorporation.
+Added: Certificate of Amendment to the Certificate of Incorporation.
(Incorporated by reference to Exhibit 3.1 to our Form 8-K, dated August 13, 2020.)
−Removed: and Restated By-laws.
+Added: Amended and Restated By-laws.
(Incorporated by reference to Exhibit 3.8 to our Form 10-K for the fiscal year ended October 31, 2019.)
−Removed: to the Amended and Restated Bylaws of the Company.
+Added: Amendment to the Amended and Restated Bylaws of the Company.
(Incorporated by reference to our Form 8-K, dated April 2, 2021.)
−Removed: of Underwriter Warrants.
+Added: Form of Underwriter Warrants.
(Incorporated by reference to Exhibit 4.1 to our Form 8-K, dated March 24, 2021.)
−Removed: of the Company’s Securities Registered under Section 12 of the Exchange Act (Incorporated by reference to the description of
−Removed: our common stock contained in our Current Report on Form 8-K filed on March 31, 2014.)
+Added: Description of the Company’s Securities Registered under Section 12 of the Exchange Act (Incorporated by reference to the description of our common stock contained in our Current Report on Form 8-K filed on March 31, 2014.)
2010 Share Incentive Plan.
(Incorporated by reference to Exhibit 10.1 to our Form 8-K, dated July 20, 2010.)
+Added: Amendment No.
1 to the 2010 Share Incentive Plan.
(Incorporated by reference to Exhibit 10.1 to our Form 8-K, dated July 7, 2011.)
+Added: Amendment No.
2 to the 2010 Share Incentive Plan.
(Incorporated by reference to Exhibit 10.1 to our Form 8-K, dated September 5, 2012.)
+Added: Amendment No.
3 to the 2010 Share Incentive Plan.
−Removed: (Incorporated by reference to Exhibit 10.1 to our Form 10-Q for the fiscal quarter ended
−Removed: January 31, 2014.)
+Added: (Incorporated by reference to Exhibit 10.1 to our Form 10-Q for the fiscal quarter ended January 31, 2014.)
2018 Share Incentive Plan.
(Incorporated by reference to Exhibit 4.13 to our Form S-8 dated October 1, 2018.)
−Removed: Agreement, dated November 13, 2017, between Certainty Therapeutics, Inc.
+Added: License Agreement, dated November 13, 2017, between Certainty Therapeutics, Inc.
and The Wistar Institute of Anatomy and Biology.
−Removed: (Incorporated
−Removed: by reference to Exhibit 10.14 to our Form 10-K, dated January 9, 2018.) (Portions of this exhibit have been redacted pursuant to
−Removed: a request for confidential treatment.
+Added: (Incorporated by reference to Exhibit 10.14 to our Form 10-K, dated January 9, 2018.) (Portions of this exhibit have been redacted pursuant to a request for confidential treatment.
The redacted portions have been separately filed with the Securities and Exchange Commission.)
−Removed: to License Agreement between Certainty Therapeutics, Inc.
+Added: Amendment to License Agreement between Certainty Therapeutics, Inc.
and The Wistar Institute of Anatomy and Biology.
−Removed: (Incorporated by reference
−Removed: to Exhibit 10.1 to our Form 10-Q for the fiscal quarter ended January 31, 2021.) (Certain information has been redacted in the marked
−Removed: portions of the exhibit.)
−Removed: and Restated Master Collaboration Agreement, dated November 1, 2021, between Certainty Therapeutics, Inc.
−Removed: Lee Moffitt Cancer
−Removed: Center and Research Institute, Inc.
+Added: (Incorporated by reference to Exhibit 10.1 to our Form 10-Q for the fiscal quarter ended January 31, 2021.) (Certain information has been redacted in the marked portions of the exhibit.)
+Added: Amended and Restated Master Collaboration Agreement, dated November 1, 2021, between Certainty Therapeutics, Inc.
+Added: Lee Moffitt Cancer Center and Research Institute, Inc.
(Incorporated by reference to Exhibit 10.8 to our Form 10-K for the fiscal year ended October 31, 2021.)
−Removed: License Agreement, dated July 8, 2019, between the Company and The Cleveland Clinic Foundation.
−Removed: (Incorporated by reference to Exhibit
−Removed: 10.1 to our Form 10-Q for the fiscal quarter ended July 31, 2019.) (Certain information has been redacted in the marked portions
−Removed: of the exhibit.)
−Removed: to Exclusive License Agreement between the Company and The Cleveland Clinic Foundation.
−Removed: (Filed herewith.)
−Removed: License Agreement, dated October 20, 2020, between the Company and The Cleveland Clinic Foundation.
−Removed: (Incorporated by reference to
−Removed: Exhibit 10.14 to our Form 10-K, for the fiscal year ended October 31, 2020.) (Certain information has been redacted in the marked
−Removed: portions of the exhibit.)
+Added: Exclusive License Agreement, dated July 8, 2019, between the Company and The Cleveland Clinic Foundation.
+Added: (Incorporated by reference to Exhibit 10.1 to our Form 10-Q for the fiscal quarter ended July 31, 2019.) (Certain information has been redacted in the marked portions of the exhibit.)
+Added: Amendment to Exclusive License Agreement between the Company and The Cleveland Clinic Foundation.
+Added: (Incorporated by reference to Exhibit 10.10 to our Form 10-K, for the fiscal year ended October 31, 2023.)
+Added: Exclusive License Agreement, dated October 20, 2020, between the Company and The Cleveland Clinic Foundation.
+Added: (Incorporated by reference to Exhibit 10.14 to our Form 10-K, for the fiscal year ended October 31, 2020.) (Certain information has been redacted in the marked portions of the exhibit.)
+Added: Amendment No.
1 to Exclusive License Agreement between the Company and The Cleveland Clinic Foundation.
−Removed: (Incorporated by reference to Exhibit
−Removed: 10.1 to our Form 10-Q for the fiscal quarter ended July 31, 2022.) (Certain information has been redacted in the marked portions
−Removed: of the exhibit.)
−Removed: of Controlled Equity Offering SM Sales Agreement (Incorporated by reference to Exhibit 10.1 to our Form S-3 dated September
−Removed: of Conduct (Incorporated by reference to Exhibit 14 to our Form 10-K, for the fiscal year ended October 31, 2020.)
−Removed: Trading Policy (Filed herewith.)
−Removed: of Anixa Biosciences, Inc.
+Added: (Incorporated by reference to Exhibit 10.1 to our Form 10-Q for the fiscal quarter ended July 31, 2022.) (Certain information has been redacted in the marked portions of the exhibit.)
+Added: Joint Development and Option Agreement, dated May 3, 2024, between the Company and The Cleveland Clinic Foundation.
+Added: (Incorporated by reference to Exhibit 10.1 to our Form 10-Q for the fiscal quarter ended April 30, 2024.) (Certain information has been redacted in the marked portions of the exhibit.)
+Added: Form of Controlled Equity Offering SM Sales Agreement (Incorporated by reference to Exhibit 10.1 to our Form S-3 dated September 9, 2022.)
+Added: Code of Conduct (Filed herewith.)
+Added: Insider Trading Policy (Incorporated by reference to Exhibit 19 to our Form 10-K, for the fiscal year ended October 31, 2023.)
+Added: Subsidiaries of Anixa Biosciences, Inc.
(Incorporated by reference to Exhibit 21 to our Form 10-K, for the fiscal year ended October 31, 2020.)
−Removed: of Haskell & White LLP.
+Added: Consent of Haskell & White LLP.
(Filed herewith.)
−Removed: Certification
−Removed: of Chief Executive Officer, pursuant to Section 302 of the Sarbanes-Oxley Act of 2002, dated January 16, 2024.
+Added: Certification of Chief Executive Officer, pursuant to Section 302 of the Sarbanes-Oxley Act of 2002, dated January 10, 2025.
(Filed herewith.)
−Removed: Certification
−Removed: of Chief Financial Officer, pursuant to Section 302 of the Sarbanes-Oxley Act of 2002, dated January 16, 2024.
+Added: Certification of Chief Financial Officer, pursuant to Section 302 of the Sarbanes-Oxley Act of 2002, dated January 10, 2025.
(Filed herewith.)
−Removed: of Chief Executive Officer, pursuant to Section 1350 of Title 18 of the United States Code, dated January 16, 2024.
+Added: Statement of Chief Executive Officer, pursuant to Section 1350 of Title 18 of the United States Code, dated January 10, 2025.
(Filed herewith.)
−Removed: of Chief Financial Officer, pursuant to Section 1350 of Title 18 of the United States Code, dated January 16, 2024.
+Added: Statement of Chief Financial Officer, pursuant to Section 1350 of Title 18 of the United States Code, dated January 10, 2025.
(Filed herewith.)
−Removed: Policy (Filed herewith.)
+Added: Clawback Policy (Incorporated by reference to Exhibit 99.1 to our Form 10-K, for the fiscal year ended October 31, 2023.)
Form 10-K Summary
−Removed: Company has elected not to include a summary pursuant to this Item 16.
−Removed: to the requirements of Section 13 or 15(d) of the Securities Exchange Act of 1934, the registrant has duly caused this report to be signed
−Removed: on its behalf by the undersigned, thereunto duly authorized.
−Removed: Biosciences, Inc.
−Removed: of the Board and
−Removed: Executive Officer
−Removed: to the requirements of the Securities Exchange Act of 1934, this report has been signed below by the following persons on behalf of the
−Removed: registrant and in the capacities and on the date indicated.
−Removed: of the Board and
−Removed: Executive Officer
−Removed: Executive Officer)
−Removed: Chief Operating Officer and
−Removed: Financial Officer
−Removed: Financial and Accounting Officer)
+Added: The Company has elected not to
+Added: include a summary pursuant to this Item 16.
+Added: Pursuant to the requirements of
+Added: Section 13 or 15(d) of the Securities Exchange Act of 1934, the registrant has duly caused this report to be signed on its behalf by the
+Added: undersigned, thereunto duly authorized.
+Added: Anixa Biosciences, Inc.
+Added: /s/ Amit Kumar
+Added: Chairman of the Board and
+Added: January 10, 2025
+Added: Chief Executive Officer
+Added: Pursuant to the requirements of
+Added: the Securities Exchange Act of 1934, this report has been signed below by the following persons on behalf of the registrant and in the
+Added: capacities and on the date indicated.
+Added: /s/ Amit Kumar
+Added: Chairman of the Board and
+Added: Chief Executive Officer
+Added: January 10, 2025
+Added: (Principal Executive Officer)
+Added: /s/ Michael J.
+Added: President, Chief Operating Officer and
+Added: Chief Financial Officer
+Added: January 10, 2025
+Added: (Principal Financial and Accounting Officer)
Titterton, Jr.
Titterton, Jr.
−Removed: Arnold Baskies
+Added: January 10, 2025
+Added: /s/ Arnold Baskies
Arnold Baskies
+Added: January 10, 2025
+Added: /s/ Emily Gottschalk
Emily Gottschalk
−Removed: BIOSCIENCES, INC.
+Added: January 10, 2025
+Added: ANIXA BIOSCIENCES, INC.
AND SUBSIDIARIES
−Removed: TO CONSOLIDATED FINANCIAL STATEMENTS
−Removed: of Independent Registered Public Accounting Firm (PCAOB ID:
−Removed: Balance Sheets as of October 31, 2023 and 2022
−Removed: Statements of Operations for the years ended October 31, 2023 and 2022
−Removed: Statements of Equity for the years ended October 31, 2023 and 2022
−Removed: Statements of Cash Flows for the years ended October 31, 2023 and 2022
−Removed: to Consolidated Financial Statements
−Removed: information required by schedules called for under Regulation S-X is either not applicable or is included in the consolidated financial
−Removed: statements or notes thereto.
−Removed: OF INDEPENDENT REGISTERED PUBLIC ACCOUNTING FIRM
−Removed: the Board of Directors and Shareholders
−Removed: Biosciences, Inc.
−Removed: on the Consolidated Financial Statements
−Removed: have audited the accompanying consolidated balance sheets of Anixa Biosciences, Inc.
−Removed: (the “Company”) as of October 31, 2023
−Removed: and 2022, and the related consolidated statements of operations, equity, and cash flows for each of the two years in the period ended
−Removed: October 31, 2023, and the related notes (collectively, the “consolidated financial statements”).
−Removed: In our opinion, the consolidated
−Removed: financial statements present fairly, in all material respects, the consolidated financial position of the Company as of October 31, 2023
−Removed: and 2022, and the consolidated results of its operations and its cash flows for each of the years in the two year period ended October
−Removed: 31, 2023, in conformity with accounting principles generally accepted in the United States of America.
−Removed: consolidated financial statements are the responsibility of the Company’s management.
−Removed: Our responsibility is to express an opinion
−Removed: on the Company’s consolidated financial statements based on our audits.
−Removed: We are a public accounting firm registered with the Public
−Removed: Company Accounting Oversight Board (United States) (“PCAOB”) and are required to be independent with respect to the Company
−Removed: in accordance with the U.S.
−Removed: federal securities laws and the applicable rules and regulations of the Securities Exchange Commission and
−Removed: conducted our audits in accordance with the standards of the PCAOB.
−Removed: Those standards require that we plan and perform the audits to obtain
−Removed: reasonable assurance about whether the consolidated financial statements are free of material misstatement, whether due to error or fraud.
−Removed: The Company is not required to have, nor were we engaged to perform, an audit of its internal control over financial reporting.
−Removed: of our audits, we are required to obtain an understanding of internal control over financial reporting but not for the purpose of expressing
−Removed: an opinion on the effectiveness of the Company’s internal control over financial reporting.
+Added: INDEX TO CONSOLIDATED FINANCIAL STATEMENTS
+Added: OCTOBER 31, 2024
+Added: Report of Independent Registered Public Accounting Firm (PCAOB ID:
+Added: Consolidated Balance Sheets as of October 31, 2024 and 2023
+Added: Consolidated Statements of Operations for the years ended October 31, 2024 and 2023
+Added: Consolidated Statements of Equity for the years ended October 31, 2024 and 2023
+Added: Consolidated Statements of Cash Flows for the years ended October 31, 2024 and 2023
+Added: Notes to Consolidated Financial Statements
+Added: Additional information required by schedules called
+Added: for under Regulation S-X is either not applicable or is included in the consolidated financial statements or notes thereto.
+Added: REPORT OF INDEPENDENT REGISTERED PUBLIC ACCOUNTING
+Added: To the Board of Directors and Shareholders
+Added: Anixa Biosciences, Inc.
+Added: Opinion on the Consolidated Financial Statements
+Added: We have audited the accompanying consolidated balance sheets of Anixa Biosciences,
+Added: (the “Company”) as of October 31, 2024 and 2023, and the related consolidated statements of operations, equity, and cash
+Added: flows for each of the two years in the period ended October 31, 2024, and the related notes (collectively, the “consolidated financial
+Added: statements”).
+Added: In our opinion, the consolidated financial statements present fairly, in all material respects, the consolidated financial
+Added: position of the Company as of October 31, 2024 and 2023, and the consolidated results of its operations and its cash flows for each of
+Added: the years in the two year period ended October 31, 2024, in conformity with accounting principles generally accepted in the United States
+Added: Basis for Opinion
+Added: These consolidated financial statements are the responsibility of the Company’s
+Added: Our responsibility is to express an opinion on the Company’s consolidated financial statements based on our audits.
+Added: We are a public accounting firm registered with the Public Company Accounting Oversight Board (United States) (“PCAOB”) and
+Added: are required to be independent with respect to the Company in accordance with the U.S.
+Added: federal securities laws and the applicable rules
+Added: and regulations of the Securities and Exchange Commission and the PCAOB.
+Added: We conducted our audits in accordance with the standards of the PCAOB.
+Added: Those standards require that we plan and perform the audits to obtain reasonable assurance about whether the consolidated financial statements
+Added: are free of material misstatement, whether due to error or fraud.
+Added: The Company is not required to have, nor were we engaged to perform,
+Added: an audit of its internal control over financial reporting.
+Added: As part of our audits, we are required to obtain an understanding of internal
+Added: control over financial reporting, but not for the purpose of expressing an opinion on the effectiveness of the Company’s internal
+Added: control over financial reporting.
Accordingly, we express no such opinion.
−Removed: audits included performing procedures to assess the risks of material misstatement of the consolidated financial statements, whether
−Removed: due to error or fraud, and performing procedures that respond to those risks.
−Removed: Such procedures included examining, on a test basis, evidence
−Removed: supporting the amounts and disclosures in the consolidated financial statements.
−Removed: Our audits also included evaluating the accounting principles
−Removed: used and significant estimates made by management, as well as evaluating the overall presentation of the consolidated financial statements.
−Removed: We believe that our audits provide a reasonable basis for our opinion.
−Removed: Audit Matters
−Removed: critical audit matter communicated below is a matter arising from the current period audit of the consolidated financial statements
−Removed: that was communicated or required to be communicated to the audit committee and that:
−Removed: (1) relate to accounts or disclosures that are
−Removed: material to the consolidated financial statements and (2) involved our especially challenging, subjective, or complex
−Removed: The communication of critical audit matters does not alter in any way our opinion on the consolidated financial
−Removed: statements, taken as a whole, and we are not, by communicating the critical audit matter below, providing separate opinions on the critical
−Removed: audit matter or on the accounts or disclosures to which it relates.
−Removed: and Development Expenses – Refer to Note 2 of the Consolidated Financial Statements
−Removed: Audit Matter Description:
−Removed: Company recognizes research and development expenses as incurred.
−Removed: Advance payments for future research and development activities are
−Removed: deferred and expensed as the services are performed.
−Removed: The Company recognizes its preclinical studies and clinical trial expenses based
−Removed: on the services performed pursuant to contracts with research institutions, clinical research organizations (“CROs”), clinical
−Removed: manufacturing organizations (“CMOs”), and other parties that conduct and manage various stages of research and development
−Removed: activities on the Company’s behalf.
−Removed: Fees for such services are recognized based on management’s estimates after considering
−Removed: the activities and tasks completed by each service provider in a given period, the time period over which services are expected to be
−Removed: performed, and the level of effort expended in each reporting period.
−Removed: each balance sheet date, management estimates prepaid and accrued research and development costs by discussing progress or stage of completion
−Removed: of activities with internal personnel and external service providers, and comparing this information to payments made, invoices received,
−Removed: and the agreed-upon contractual fee to be paid for such services in the applicable contract or statements of work.
−Removed: addition, the Company allocates certain internal compensation costs to research and development expenses based on management’s
−Removed: estimates of each employee’s time and effort expended.
+Added: Our audits included performing procedures to assess the risks of material
+Added: misstatement of the consolidated financial statements, whether due to error or fraud, and performing procedures that respond to those
+Added: Such procedures included examining, on a test basis, evidence supporting the amounts and disclosures in the consolidated financial
+Added: Our audits also included evaluating the accounting principles used and significant estimates made by management, as well as
+Added: evaluating the overall presentation of the consolidated financial statements.
+Added: We believe that our audits provide a reasonable basis for
+Added: The critical audit matter communicated below is a matter arising from the
+Added: current period audit of the consolidated financial statements that was communicated or required to be communicated to the audit committee
+Added: (1) relate to accounts or disclosures that are material to the consolidated financial statements, and (2) involved our especially
+Added: challenging, subjective, or complex judgments.
+Added: The communication of the critical audit matter does not alter in any way our opinion on
+Added: the consolidated financial statements, taken as a whole, and we are not, by communicating the critical audit matter below, providing separate
+Added: opinions on the critical audit matter or on the accounts or disclosures to which it relates.
+Added: Research and Development Expenses – Refer to Note 2 of the consolidated
+Added: financial statements
+Added: Critical Audit Matter Description:
+Added: The Company recognizes research and development expenses as incurred.
+Added: payments for future research and development activities are deferred and expensed as the services are performed.
+Added: The Company recognizes
+Added: its preclinical studies and clinical trial expenses based on the services performed pursuant to contracts with research institutions,
+Added: clinical research organizations (“CROs”), clinical manufacturing organizations (“CMOs”), and other parties that
+Added: conduct and manage various stages of research and development activities on the Company’s behalf.
+Added: Fees for such services are recognized
+Added: based on management’s estimates after considering the activities and tasks completed by each service provider in a given period,
+Added: the time period over which services are expected to be performed, and the level of effort expended in each reporting period.
+Added: At each balance sheet date, management estimates prepaid and accrued research
+Added: and development costs by discussing progress or stage of completion of activities with internal personnel and external service providers,
+Added: and comparing this information to payments made, invoices received, and the agreed-upon contractual fee to be paid for such services in
+Added: the applicable contract or statements of work.
+Added: In addition, the Company allocates certain internal compensation costs
+Added: to research and development expenses based on management’s estimates of each employee’s time and effort expended.
the Critical Matter was Addressed in the Audit:
−Removed: primary procedures we performed to address this critical audit matter included the following:
−Removed: obtained an understanding, and evaluated the design and implementation, of controls relating
−Removed: to research and development costs, including controls over the review of third-party contracts,
−Removed: the process of gathering information from external and internal sources and management’s
−Removed: review thereof, and the determination of prepaid positions, period-end accruals, and expense
−Removed: the Company’s significant third-party contracts, we performed the following procedures:
−Removed: obtained and read related master service agreements, statements of work, or other supporting
−Removed: agreements with the research institution, CRO, or CMO.
−Removed: performed corroborating inquiries with management personnel responsible for the oversight
−Removed: of the activities regarding the nature and status of work performed.
−Removed: evaluated evidence of services provided by third parties including invoices regarding activities
−Removed: completed, and we inspected evidence supporting payments made by the Company.
−Removed: compared the data and evidence obtained from internal and external sources to the amounts
−Removed: recorded by management and recalculated the related research and development expense and
−Removed: prepaid research and development expense.
−Removed: the Company’s internal compensation allocations, we performed the following procedures:
−Removed: performed corroborating inquiries with management personnel responsible for the oversight
−Removed: of the activities regarding the nature of employee services performed.
−Removed: evaluated the reasonableness of allocations estimated by management by comparisons with prior
−Removed: periods and evaluating the reasonableness of significant changes made by management.
−Removed: obtained written representations from management regarding the appropriateness of allocation
−Removed: have served as the Company’s auditor since 2013
−Removed: BIOSCIENCES, INC.
+Added: The primary procedures we performed to address this critical audit matter
+Added: included the following:
+Added: We obtained an understanding, and evaluated the design and implementation, of controls relating to research and development costs, including controls over the review of third-party contracts, the process of gathering information from external and internal sources and management’s review thereof, and the determination of prepaid positions, period-end accruals, and expense allocations.
+Added: For the Company’s significant third-party contracts, we performed the following procedures:
+Added: We obtained and read related master service agreements, statements of work, or other supporting agreements with the research institution, CRO, or CMO.
+Added: We performed corroborating inquiries with management personnel responsible for the oversight of the activities regarding the nature and status of work performed.
+Added: We evaluated evidence of services provided by third parties including invoices regarding activities completed, and we inspected evidence supporting payments made by the Company.
+Added: We compared the data and evidence obtained from internal and external sources to the amounts recorded by management and recalculated the related research and development expense and prepaid research and development expense.
+Added: For the Company’s internal compensation allocations, we performed the following procedures:
+Added: We performed corroborating inquiries with management personnel responsible for the oversight of the activities regarding the nature of employee services performed.
+Added: We evaluated the reasonableness of allocations estimated by management by comparisons with prior periods, evaluating the reasonableness of significant changes made by management, and performing sensitivity analysis.
+Added: We obtained written representations from management regarding the appropriateness of allocation estimates.
+Added: Haskell & White LLP
+Added: We have served as the Company’s auditor since
+Added: Irvine, California
+Added: January 10, 2025
+Added: ANIXA BIOSCIENCES, INC.
AND SUBSIDIARIES
−Removed: BALANCE SHEETS
−Removed: thousands, except share and per share data)
+Added: CONSOLIDATED BALANCE SHEETS
+Added: (in thousands, except share
+Added: and per share data)
Current assets:
−Removed: Cash and cash
+Added: Cash and cash equivalents
Short–term investments
−Removed: expenses and other current assets
+Added: Prepaid expenses and other current assets
Total current assets
−Removed: Operating lease right-of-use
−Removed: LIABILITIES AND
+Added: Operating lease right-of-use asset
+Added: LIABILITIES AND EQUITY
Current liabilities:
1 unchanged sentence
Accrued expenses
−Removed: lease liability
−Removed: Total current liabilities
Operating lease liability
+Added: Total current liabilities
+Added: Operating lease liability, non-current
+Added: Total liabilities
Commitments and contingencies (Note 6)
Shareholders’ equity:
−Removed: Preferred stock, par value
−Removed: 19,860 shares
−Removed: issued or outstanding
−Removed: Series A convertible preferred
−Removed: stock, par value $ 100
+Added: Preferred stock, par value $ 100 per share;
19,860 shares authorized;
−Removed: shares issued or outstanding
+Added: no shares issued or outstanding
+Added: Series A convertible preferred stock, par value $ 100 per share;
+Added: 140 shares authorized;
+Added: no shares issued or outstanding
Preferred stock, value
−Removed: Common stock, par value
−Removed: 100,000,000 shares
−Removed: 31,145,219 and
−Removed: 30,913,902 shares
−Removed: issued and outstanding as of October 31, 2023 and 2022, respectively
+Added: Common stock, par value $ .01 per share;
+Added: 100,000,000 shares authorized;
+Added: 32,196,862 and 31,145,219 shares issued and outstanding as of October 31, 2024 and 2023, respectively
Additional paid-in capital
−Removed: Total shareholders’
−Removed: Noncontrolling
−Removed: interest (Note 2)
−Removed: liabilities and equity
−Removed: accompanying notes are an integral part of these statements.
−Removed: BIOSCIENCES, INC.
+Added: Accumulated deficit
+Added: Treasury stock, 2,000 shares at cost
+Added: Total shareholders’ equity
+Added: Noncontrolling interest (Note 2)
+Added: Total liabilities and equity
+Added: The accompanying notes are an integral part of these
+Added: ANIXA BIOSCIENCES, INC.
AND SUBSIDIARIES
−Removed: STATEMENTS OF OPERATIONS
−Removed: thousands, except per share data)
−Removed: the years ended October 31,
+Added: CONSOLIDATED STATEMENTS OF
+Added: (in thousands, except per
+Added: For the years ended October 31,
Operating costs and expenses:
−Removed: Inventor royalties, contingent
−Removed: legal fees, litigation and licensing expenses
−Removed: Research and development
−Removed: expenses (including non-cash share based compensation expenses of $ 2,037
−Removed: and $ 3,635 ,
−Removed: respectively)
−Removed: and administrative expenses (including non-cash share based compensation expenses of $ 2,698
−Removed: and $ 3,117 ,
−Removed: respectively)
−Removed: Total operating costs
+Added: Inventor royalties, contingent legal fees, litigation and licensing expenses
+Added: Research and development expenses (including non-cash stock-based compensation expenses of $ 1,859 and $ 2,037 , respectively)
+Added: General and administrative expenses (including non-cash stock-based compensation expenses of $ 2,923 and $ 2,698 , respectively)
+Added: Total operating costs and expenses
Loss from operations
Interest income
−Removed: Net loss attributable
−Removed: to noncontrolling interest
−Removed: Net loss attributable
−Removed: to common stockholders
+Added: Net loss attributable to noncontrolling interest
+Added: Net loss attributable to common shareholders
Net loss per share:
+Added: Basic and diluted
Weighted average common shares outstanding:
−Removed: accompanying notes are an integral part of these statements.
−Removed: BIOSCIENCES, INC.
+Added: Basic and diluted
+Added: The accompanying notes are an integral part of these
+Added: ANIXA BIOSCIENCES, INC.
AND SUBSIDIARIES
−Removed: STATEMENTS OF EQUITY
−Removed: THE YEARS ENDED OCTOBER 31, 2023 AND 2022
−Removed: thousands, except share data)
−Removed: Shareholders’
−Removed: October 31, 2021
+Added: CONSOLIDATED STATEMENTS OF EQUITY
+Added: FOR THE YEARS ENDED OCTOBER 31, 2024 AND 2023
+Added: (in thousands, except share data)
+Added: Additional Paid-in
+Added: Total Shareholders’
+Added: BALANCE, October 31, 2022
$ ( 218,385 )
−Removed: option compensation to employees and directors
−Removed: options and warrants issued to consultants
−Removed: stock issued upon exercise of stock options and warrants
−Removed: stock issued to consultants
−Removed: stock issued pursuant to employee stock purchase plan
−Removed: October 31, 2022
+Added: Stock option compensation to employees and directors
+Added: Stock options issued to consultants
+Added: Common stock issued upon exercise of stock options
+Added: Common stock issued to consultants
+Added: Common stock issued pursuant to employee stock purchase plan
+Added: BALANCE, October 31, 2023
$ ( 228,196 )
$ ( 228,196 )
−Removed: option compensation to employees and directors
−Removed: options issued to consultants
−Removed: stock issued upon exercise of stock options
−Removed: stock issued to consultants
−Removed: stock issued pursuant to employee stock purchase plan
−Removed: October 31, 2023
+Added: Stock option compensation to employees and directors
+Added: Stock options issued to consultants
+Added: Common stock issued upon exercise of stock options
+Added: Common stock issued to consultants
+Added: Common stock issued in an at-the-market offering, net of offering expenses of $ 168
+Added: Common stock issued pursuant to employee stock purchase plan
+Added: Purchase of treasury stock
+Added: BALANCE, October 31, 2024
$ ( 240,750 )
$ ( 240,750 )
−Removed: accompanying notes are an integral part of these statements.
−Removed: BIOSCIENCES, INC.
+Added: The accompanying notes are an integral part of these
+Added: ANIXA BIOSCIENCES, INC.
AND SUBSIDIARIES
−Removed: STATEMENTS OF CASH FLOWS
−Removed: the years ended October 31,
+Added: CONSOLIDATED STATEMENTS OF CASH FLOWS
+Added: (in thousands)
+Added: For the years ended October 31,
Cash flows from operating activities:
−Removed: Reconciliation of net loss to net cash used
−Removed: in operating activities:
−Removed: Stock option compensation
−Removed: to employees and directors
−Removed: Stock options and warrants
−Removed: issued to consultants
−Removed: Common stock issued to
−Removed: Amortization of operating
−Removed: lease right-of-use asset
−Removed: Change in operating assets
−Removed: and liabilities:
−Removed: Prepaid expenses and other
−Removed: current assets
+Added: Reconciliation of net loss to net cash used in operating activities:
+Added: Stock option compensation to employees and directors
+Added: Stock options issued to consultants
+Added: Common stock issued to consultants
+Added: Amortization of operating lease right-of-use asset
+Added: Change in operating assets and liabilities:
+Added: Prepaid expenses and other current assets
Accounts payable
Accrued expenses
−Removed: lease liability
−Removed: cash used in operating activities
+Added: Operating lease liability
+Added: Net cash used in operating activities
Cash flows from investing activities:
−Removed: Disbursements to acquire
−Removed: short-term investments
−Removed: from maturities of short-term investments
−Removed: cash used in investing activities
+Added: Disbursements to acquire short-term investments
+Added: Proceeds from maturities of short-term investments
+Added: Net cash provided by (used in) investing activities
Cash flows from financing activities:
−Removed: Proceeds from sale of common
−Removed: stock pursuant to employee stock purchase plan
−Removed: from exercise of stock options and warrants
−Removed: cash provided by financing activities
−Removed: Net decrease in cash and cash equivalents
−Removed: Cash and cash equivalents
−Removed: at beginning of year
−Removed: Cash and cash equivalents
−Removed: at end of year
+Added: Proceeds from sale of common stock in an at-the-market offering, net of offering expenses of $168
+Added: Proceeds from sale of common stock pursuant to employee stock purchase plan
+Added: Proceeds from exercise of stock options
+Added: Disbursements for purchases of treasury stock
+Added: Net cash provided by financing activities
+Added: Net increase (decrease) in cash and cash equivalents
+Added: Cash and cash equivalents at beginning of year
+Added: Cash and cash equivalents at end of year
Supplemental cash flow information:
−Removed: proceeds from interest income
−Removed: accompanying notes are an integral part of these statements.
−Removed: BIOSCIENCES, INC.
+Added: Cash proceeds from interest income
+Added: Supplemental disclosure of non-cash investing activity:
+Added: Modification to operating lease right-of-use asset
+Added: Supplemental disclosure of non-cash financing activity:
+Added: Modification to operating lease liability
+Added: The accompanying notes are an integral part of these
+Added: ANIXA BIOSCIENCES, INC.
AND SUBSIDIARIES
−Removed: TO CONSOLIDATED FINANCIAL STATEMENTS
+Added: NOTES TO CONSOLIDATED FINANCIAL STATEMENTS
BUSINESS AND FUNDING
−Removed: used herein, “we,” “us,” “our,” the “Company” or “Anixa” means Anixa Biosciences,
−Removed: and its consolidated subsidiaries.
−Removed: Biosciences, Inc.
−Removed: is a biotechnology company developing vaccines and therapies that are focused on critical unmet needs in oncology.
−Removed: Our vaccine programs include (i) the development of a preventative vaccine against triple negative breast cancer (“TNBC”),
−Removed: the most lethal form of breast cancer, as well other forms of breast cancer and (ii) the development of a preventative vaccine against
−Removed: ovarian cancer.
−Removed: Our therapeutics programs include (i) the development of a chimeric endocrine receptor T cell therapy, a novel form of
−Removed: chimeric antigen receptor T cell (“CAR-T”) technology, initially focused on treating ovarian cancer, which is being developed
−Removed: at our subsidiary, Certainty Therapeutics, Inc.
−Removed: (“Certainty”), and (ii) until March 2023, the development of anti-viral drug
−Removed: candidates for the treatment of COVID-19 focused on inhibiting certain protein functions of the virus.
−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 mother’s mammary tissue.
−Removed: This protein disappears when the mother is no longer lactating, but reappears in
−Removed: many forms of breast cancer, especially TNBC.
+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 programs include (i)
+Added: the development of a chimeric endocrine receptor-T cell therapy, a novel form of chimeric antigen receptor-T cell (“CAR-T”)
+Added: technology, initially focused on treating ovarian cancer, which is being developed at our subsidiary, Certainty Therapeutics, Inc.
+Added: (“Certainty”),
+Added: and (ii) until March 2023, the development of anti-viral drug candidates for the treatment of COVID-19.
+Added: Our vaccine programs include (i)
+Added: the development of a vaccine against breast cancer, initially focused on triple negative breast cancer (“TNBC”), the most
+Added: lethal form of breast cancer, (ii) the development of a vaccine against ovarian cancer, and (iii) a vaccine discovery program utilizing
+Added: the same mechanism as our breast and ovarian cancer vaccines, to develop additional cancer vaccines to address many intractable cancers,
+Added: including high incidence malignancies in lung, colon and prostate.
+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.
+Added: With respect to Certainty’s equity obligations
+Added: to Wistar, Certainty issued to Wistar shares of its common stock equal to five percent ( 5 %) of the common stock of Certainty, such equity
+Added: stake subject to dilution by further funding of Certainty’s activities by the Company.
+Added: Due to such Company funding, Wistar’s
+Added: equity stake in Certainty was 4.4 % as of October 31, 2024.
+Added: Certainty, in collaboration with
+Added: Lee Moffitt Cancer Center and Research Institute, Inc.
+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 20 months
+Added: past initial treatment.
+Added: In the case of this patient, due to the encouraging results with her initial treatment, we sought single patient
+Added: Investigational New Drug (“IND”) application permission from the FDA to re-dose her.
+Added: This re-dosing was approved by the FDA,
+Added: and we administered her second treatment in October 2024.
+Added: This second treatment appears to have been well-tolerated by the patient.
+Added: November 2024, we treated the first patient in the third dose cohort, where patients are administered a ten-times higher dose of cells
+Added: than the patients in the first dose cohort.
+Added: As of January 10, 2025, we have treated two patients in this dose cohort and the treatment
+Added: at this dose level appears to be well-tolerated by the patients.
+Added: We anticipate completing treatment of patients in the third dose cohort
+Added: in February 2025, and commencing treatment of the fourth dose cohort—at a three-times higher dose than the third dose cohort—shortly
+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
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 dosing
−Removed: patients in a Phase 1 clinical trial of our breast cancer vaccine.
−Removed: This study, which is being funded by a U.S.
−Removed: Department of Defense
−Removed: grant to Cleveland Clinic, is a multiple-ascending dose Phase 1 trial to determine the maximum tolerated dose (“MTD”) of
−Removed: the vaccine in patients with early-stage, triple-negative breast cancer as well as monitor immune response.
−Removed: The study is being conducted
−Removed: at Cleveland Clinic.
−Removed: The first segment of the study, Phase 1a, will consist of 18 to 24 patients who have completed treatment for early-stage,
−Removed: triple-negative breast cancer within the past three years and are currently tumor-free but at high risk for recurrence.
−Removed: that 42% of TNBC patients will have a recurrence of their cancer, with most of the recurrences occurring in the first two to three years
−Removed: after standard of care treatment.
−Removed: During the course of the Phase 1a study, participants will receive three vaccinations, each two weeks
−Removed: apart, and will be closely monitored for side effects and immune response.
−Removed: In January 2023, the number of participants in each dose cohort
−Removed: was expanded, and as of August 2023, we had completed vaccinating all patients in these expanded cohorts.
−Removed: In December 2023, we presented
−Removed: the immunological data collected to date at the San Antonio Breast Cancer Symposium.
−Removed: The data presented show that in the vaccinated women
−Removed: who had been tested to date, various levels of antigen-specific T cell responses were observed at all dose levels.
−Removed: We have begun vaccinating
−Removed: participants in up to three additional dose cohorts at dose levels higher than the currently determined MTD and lower than the highest
−Removed: dose where we observed dose limiting toxicity.
−Removed: Further, we have commenced vaccination of participants in the second segment of the trial,
−Removed: Phase 1b, that includes participants who have never had cancer, but carry certain genetic mutations such as BRCA1, BRCA2 or PALB2, that
−Removed: indicate a greater risk of developing TNBC in the future, and have elected to have a prophylactic mastectomy.
−Removed: Finally, we are currently
−Removed: enrolling participants in the third segment of the trial, Phase 1c, that includes post-operative TNBC patients that have residual disease
−Removed: following neoadjuvant chemo-immunotherapy and are currently undergoing treatment with pembrolizumab (Keytruda®).
−Removed: BIOSCIENCES, INC.
−Removed: AND SUBSIDIARIES
−Removed: TO CONSOLIDATED FINANCIAL STATEMENTS
−Removed: November 2020, we executed a license agreement with Cleveland Clinic pursuant to which the Company was granted an exclusive worldwide,
+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,
royalty-bearing license to use certain intellectual property owned or controlled by Cleveland Clinic relating to certain ovarian cancer
vaccine technology.
−Removed: The license agreement requires us to make certain cash payments to Cleveland Clinic upon achievement of specific
−Removed: development milestones.
−Removed: This technology pertains to among other things, the use of vaccines for the treatment or prevention of ovarian
−Removed: cancers which express the anti-Mullerian hormone receptor 2 protein containing an extracellular domain (“AMHR2-ED”).
−Removed: tissue, this protein regulates growth and development of egg-containing follicles in the ovary.
−Removed: While expression of AMHR2-ED naturally
−Removed: and markedly declines during menopause, this protein is expressed at high levels in the ovaries of postmenopausal women with ovarian
−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.
+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
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 transfer of any rights of the
−Removed: Company’s assets.
−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.
−Removed: With respect to Certainty’s equity obligations
−Removed: to Wistar, Certainty issued to Wistar shares of its common stock equal to five percent ( 5 %)
−Removed: of the common stock of Certainty, such equity stake subject to dilution by further funding of Certainty’s activities by the Company.
−Removed: Due to such Company funding, Wistar’s equity stake in Certainty was 4.6% as of October 31, 2023.
−Removed: in collaboration with the H.
−Removed: 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 appears to have been well-tolerated by all patients treated to date.
−Removed: We anticipate that we will begin enrolling
−Removed: the successive patient cohort, that we expect to give a three-times higher dose of cells, in the first calendar quarter of 2024.
−Removed: study is a dose-escalation trial with two arms based on delivery method—intraperitoneal or intravenous—to determine the maximum
−Removed: tolerated dose in patients with recurrent epithelial ovarian cancer and to assess persistence, expansion and efficacy of the modified
−Removed: The study is being conducted at Moffitt and will consist of 24 to 48 patients who have received at least two prior lines of
−Removed: chemotherapy.
−Removed: The study is estimated to be completed in two to four years depending on multiple factors including when maximum tolerated
−Removed: dose is reached, the rate of patient enrollment, and how long we maintain the two different delivery methods.
−Removed: BIOSCIENCES, INC.
−Removed: AND SUBSIDIARIES
−Removed: TO CONSOLIDATED FINANCIAL STATEMENTS
−Removed: April 2020, we entered into a collaboration with OntoChem GmbH (“OntoChem”) which was later assigned to MolGenie GmbH, a
−Removed: company spun-out from OntoChem focused on drug discovery and development, to discover and ultimately develop anti-viral drug candidates
−Removed: against COVID-19.
−Removed: Through this collaboration, we identified compounds that appeared to be effective in disrupting the main protease of
−Removed: SARS-CoV-2, the virus that causes the disease COVID-19.
−Removed: While our compounds have shown promise as an effective treatment, results of
−Removed: animal studies indicate that there is not sufficient oral bioavailability, and it is unclear whether an orally delivered treatment may
−Removed: be developed.
−Removed: We do not currently believe that there is a viable market for an injectable treatment given the current oral treatments
−Removed: Furthermore, we believe the needed additional investment in research for alternative delivery methods would divert resources
−Removed: from more promising projects.
−Removed: Therefore, in March 2023, we decided to pause further development of our COVID-19 therapeutic.
−Removed: to prosecute our U.S.
−Removed: patent applications of this technology and may decide to restart development at some time in the future.
−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 (during the year ended October 31, 2023, we derived approximately $ 210,000
−Removed: of revenue from these activities).
−Removed: generated any revenue to date from our vaccine or therapeutics programs.
−Removed: In addition, while we pursue our vaccine and therapeutics programs,
−Removed: we may also make investments in and form new companies to develop additional emerging technologies.
−Removed: We do not expect to begin generating
−Removed: revenue with respect to any of our current vaccine or therapy programs in the near term.
−Removed: We hope to achieve a profitable outcome by eventually
−Removed: licensing our technologies to large pharmaceutical companies that have the resources and infrastructure in place to manufacture, market
−Removed: and sell our technologies as vaccines or therapeutics.
−Removed: The eventual licensing of any of our technologies may take several years, if it
−Removed: 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 January 16, 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: We have implemented a business
−Removed: model that conserves funds by collaborating with third parties to develop our technologies.
−Removed: However, our projections of future cash needs
−Removed: and cash flows may differ from actual results.
−Removed: If current cash on hand, cash equivalents, short-term investments and cash that may be
−Removed: generated from our business operations are insufficient to continue to operate our business, or if we elect to invest in or acquire a
−Removed: company or companies or new technology or technologies that are synergistic with or complementary to our technologies, we may be required
−Removed: to obtain more working capital.
−Removed: Under our at-the-market equity program which is currently effective and may remain available for us to
−Removed: use in the future, as of October 31, 2023, we may sell up to $ 100
−Removed: million of common stock.
−Removed: We did not sell any
−Removed: shares under our at-the-market equity program during the fiscal year ended October 31, 2023.
−Removed: We may seek to obtain working capital during
−Removed: our fiscal year 2024 or thereafter through sales of our equity securities or through bank credit facilities or public or private debt
−Removed: from various financial institutions where possible.
−Removed: We cannot be certain that additional funding will be available on acceptable terms,
−Removed: If we do identify sources for additional funding, the sale of additional equity securities or convertible debt will result
−Removed: in dilution to our stockholders.
−Removed: We can give no assurance that we will generate sufficient cash flows in the future to satisfy our liquidity
−Removed: requirements or sustain future operations, or that other sources of funding, such as sales of equity or debt, would be available or would
−Removed: be approved by our security holders, if needed, on favorable terms or at all.
−Removed: If we fail to obtain additional working capital as and
−Removed: when needed, such failure could have a material adverse impact on our business, results of operations and financial condition.
−Removed: such lack of funds may inhibit our ability to respond to competitive pressures or unanticipated capital needs, or may force us to reduce
−Removed: operating expenses, which would significantly harm the business and development of operations.
−Removed: BIOSCIENCES, INC.
−Removed: AND SUBSIDIARIES
−Removed: TO CONSOLIDATED FINANCIAL STATEMENTS
+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.
+Added: We have not generated any revenue to date from our vaccine or therapeutics programs.
+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
+Added: as of January 10, 2025, we believe that our existing cash, cash equivalents, short-term investments and expected cash flows will be sufficient
+Added: to fund our activities for at least the next twelve months.
+Added: We have implemented a business model that conserves funds by collaborating
+Added: with third parties to develop our technologies.
+Added: However, our projections of future cash needs and cash flows may differ from actual results.
+Added: If current cash on hand, cash equivalents, short-term investments and cash that may be generated from our business operations are insufficient
+Added: to continue to operate our business, or if we elect to invest in or acquire a company or companies or new technology or technologies that
+Added: are synergistic with or complementary to our technologies, we may be required to obtain more working capital.
+Added: During the year ended October
+Added: 31, 2024, we raised approximately $ 2,955,000 , net of expenses, through an at-the-market equity offering of 785,290 shares of common stock.
+Added: Under our at-the-market equity program, which is currently effective and may remain available for us to use in the future, as of October
+Added: 31, 2024, we may sell up to $ 97 million of common stock.
+Added: We may seek to obtain working capital during our fiscal year 2025 or thereafter
+Added: through sales of our equity securities or through bank credit facilities or public or private debt from various financial institutions
+Added: where possible.
+Added: We cannot be certain that additional funding will be available on acceptable terms, or at all.
+Added: If we do identify sources
+Added: for additional funding, the sale of additional equity securities or convertible debt will result in dilution to our stockholders.
+Added: give no assurance that we will generate sufficient cash flows in the future to satisfy our liquidity requirements or sustain future operations,
+Added: or that other sources of funding, such as sales of equity or debt, would be available or would be approved by our security holders, if
+Added: needed, on favorable terms or at all.
+Added: If we fail to obtain additional working capital as and when needed, such failure could have a material
+Added: adverse impact on our business, results of operations and financial condition.
+Added: Furthermore, such lack of funds may inhibit our ability
+Added: to respond to competitive pressures or unanticipated capital needs, or may force us to reduce operating expenses, which could significantly
+Added: harm the business and development of operations.
SUMMARY OF SIGNIFICANT ACCOUNTING POLICIES
−Removed: of Presentation
−Removed: consolidated financial statements include the accounts of Anixa Biosciences, Inc.
+Added: Basis of Presentation
+Added: The consolidated financial statements
+Added: include the accounts of Anixa Biosciences, Inc.
and its wholly and majority owned subsidiaries.
−Removed: intercompany transactions have been eliminated.
−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 two years ended October 31, 2023 (in thousands):
+Added: All intercompany transactions have been
+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 two years ended October 31, 2024 (in thousands):
OF CHANGES IN NONCONTROLLING INTEREST
Balance October 31, 2022
−Removed: Net loss attributable
−Removed: to noncontrolling interest
+Added: Net loss attributable to noncontrolling interest
Balance October 31, 2023
−Removed: Net loss attributable
−Removed: to noncontrolling interest
+Added: Net loss attributable to noncontrolling interest
Balance October 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: 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 %
−Removed: of the revenue was recognized upon the execution of the agreements.
−Removed: BIOSCIENCES, INC.
−Removed: AND SUBSIDIARIES
−Removed: TO CONSOLIDATED FINANCIAL STATEMENTS
−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, licensing and enforcement related research and consulting and other expenses paid to third-parties.
−Removed: These costs are
−Removed: included under the caption “Operating costs and expenses” in the accompanying consolidated statements of operations.
−Removed: and Development Expenses
−Removed: and development expenses consist primarily of payments to third parties for research and development activities, including expenses related
−Removed: to clinical trials, employee compensation, and other direct costs associated with developing our therapeutics and vaccines.
−Removed: recognize research and development expenses as incurred.
−Removed: Advance payments for future research and development activities are deferred
−Removed: and expensed as the services are performed.
−Removed: We recognize our preclinical studies and clinical trial expenses based on the services performed
−Removed: pursuant to contracts with research institutions, clinical research organizations (“CROs”), clinical manufacturing organizations
−Removed: (“CMOs”), and other parties that conduct and manage various stages of research and development activities on our behalf.
−Removed: Fees for such services are recognized based on management’s estimates after considering the activities and tasks completed by each
−Removed: service provider in a given period, the time period over which services are expected to be performed, and the level of effort expended
−Removed: in each reporting period.
−Removed: each balance sheet date, management estimates prepaid and accrued research and development costs by discussing progress or stage of completion
+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.
+Added: We recognize research and development expenses as incurred.
+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
of activities with internal personnel and external service providers, and comparing this information to payments made, invoices received,
and the agreed-upon contractual fee to be paid for such services in the applicable contract or statements of work.
−Removed: In addition, we allocate certain internal compensation
−Removed: costs to research and development expenses based on management’s estimates of each employee’s time and effort expended.
−Removed: Value Measurements
−Removed: Standards Codification (“ASC”) 820, Fair Value Measurements and Disclosures (“ASC 820”), defines fair value,
−Removed: establishes a framework for measuring fair value under U.S.
−Removed: generally accepted accounting principles (GAAP), and expands disclosures
−Removed: about fair value measurements.
−Removed: In accordance with ASC 820, we have categorized our financial assets and liabilities, based on the priority
−Removed: of the inputs to the valuation technique, into a three-level fair value hierarchy as set forth below.
−Removed: If the inputs used to measure the
−Removed: financial instruments fall within different levels of the hierarchy, the categorization is based on the lowest level input that is significant
−Removed: to the fair value measurement of the instrument.
−Removed: assets and liabilities recorded in the accompanying consolidated balance sheets are categorized based on the inputs to the valuation
−Removed: 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: BIOSCIENCES, INC.
−Removed: AND SUBSIDIARIES
−Removed: TO CONSOLIDATED FINANCIAL STATEMENTS
−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: 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.
+Added: The Company has no Bitcoin Assets as of October 31, 2024 and 2023.
+Added: Fair Value Measurements
+Added: Accounting Standards Codification
+Added: (“ASC”) 820, Fair Value Measurements and Disclosures (“ASC 820”), defines fair value, establishes a framework
+Added: for measuring fair value under U.S.
+Added: generally accepted accounting principles (GAAP), and expands disclosures about fair value measurements.
+Added: In accordance with ASC 820, we have categorized our financial assets and liabilities, based on the priority of the inputs to the valuation
+Added: technique, into a three-level fair value hierarchy as set forth below.
+Added: If the inputs used to measure the financial instruments fall within
+Added: different levels of the hierarchy, the categorization is based on the lowest level input that is significant to the fair value measurement
+Added: of the instrument.
+Added: Financial assets and liabilities
+Added: recorded in the accompanying consolidated balance sheets are categorized based on the inputs to the valuation techniques as follows:
+Added: Level 1 – Financial instruments whose
+Added: values are based on unadjusted quoted prices for identical assets or liabilities in an active market which we have the ability to access
+Added: at the measurement date.
+Added: Level 2 – Financial instruments whose
+Added: values are based on quoted market prices in markets where trading occurs infrequently or whose values are based on quoted prices of instruments
+Added: with similar attributes in active markets.
+Added: Level 3 – Financial instruments whose
+Added: values are based on prices or valuation techniques that require inputs that are both unobservable and significant to the overall fair
+Added: value measurement.
+Added: These inputs reflect management’s own assumptions about the assumptions a market participant would use in pricing
+Added: the instrument.
+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):
OF FAIR VALUE MEASUREMENTS
1 unchanged sentence
Cash equivalents
−Removed: Certificates of deposit:
−Removed: Short term investments
treasury bills:
−Removed: term investments
+Added: Short term investments
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, 2022 (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, 2023 (in thousands):
Money market funds:
1 unchanged sentence
Certificates of deposit:
−Removed: Cash equivalents
Short term investments
treasury bills:
−Removed: term investments
+Added: Short term investments
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.
−Removed: Cash equivalents are stated at carrying value which approximates fair value.
−Removed: equivalents consist of highly liquid, short-term investments with original maturities of three months or less when purchased.
−Removed: October 31, 2023 and 2022, we had certificates of deposit and United States treasury bills with maturities greater than 90 days and less
−Removed: than 12 months when acquired of approximately $ 22,929,000
−Removed: and $ 17,327,000 ,
−Removed: respectively, that were classified as short-term investments and reported at fair value.
−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: BIOSCIENCES, INC.
−Removed: AND SUBSIDIARIES
−Removed: TO CONSOLIDATED FINANCIAL STATEMENTS
−Removed: maintain equity incentive plans under which we may grant incentive stock options, non-qualified stock options, stock appreciation rights,
−Removed: 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 consultants using the accounting guidance in ASC 718, Stock Compensation
−Removed: We estimate the fair value of service-based stock options on the date of grant, using the Black-Scholes pricing
−Removed: model, and recognize compensation expense over the requisite service period of the grant.
−Removed: recorded stock-based compensation expense, related to service-based stock options granted to employees and directors, of approximately
−Removed: and $ 3,463,000 ,
−Removed: during the years ended October 31, 2023 and 2022, respectively.
−Removed: Included in stock-based compensation cost for service-based options granted
−Removed: to employees and directors during the years ended October 31, 2023 and 2022 was approximately $ 3,023,000
−Removed: and $ 2,788,000 ,
−Removed: respectively, related to the amortization of compensation cost for stock options granted in prior periods but not yet vested.
−Removed: As of October
−Removed: 31, 2023, there was unrecognized compensation cost related to non-vested service-based stock options granted to employees and directors
−Removed: of approximately $ 5,194,000 ,
−Removed: which will be recognized over a weighted-average period of 1.7
−Removed: stock options that vest based on market conditions, such as the trading price of the Company’s common stock exceeding certain price
−Removed: targets, we use a Monte Carlo Simulation in estimating the fair value at grant date and recognize compensation expense over the implied
−Removed: service period (median time to vest).
−Removed: On June 1, 2021, our Chairman, then-President and Chief Executive Officer and our Chief Operating
−Removed: Officer and Chief Financial Officer were awarded market condition stock options for 2,000,000
−Removed: shares and 100,000
−Removed: shares of common stock, respectively, that vest
−Removed: in four equal installments upon the Company’s share price achieving targets ranging from $ 5.00
−Removed: per share, with implied service periods of three
−Removed: to fifteen months.
−Removed: The assumptions used in the Monte Carlo Simulation for the June 1, 2021 grants were stock price on date of grant and
−Removed: exercise price of $ 4.02 ,
−Removed: contract term of 10
−Removed: years, expected volatility of 75 %
−Removed: and risk-free interest rate of 1.62 %.
−Removed: As of October 31, 2023, 500,000
−Removed: options and 25,000
−Removed: options granted to our Chairman, then-President
−Removed: and Chief Executive Officer and our Chief Operating Officer and Chief Financial Officer, respectively, have vested.
−Removed: the year ended October 31, 2023, we recorded no
−Removed: stock-based compensation expense related to market
−Removed: condition stock options granted to employees.
−Removed: We recorded stock-based compensation expense related to market condition stock options
−Removed: granted to employees of approximately $ 2,537,000
−Removed: during the year ended October 31, 2022, which
−Removed: amount represented expense related to the amortization of compensation cost for stock options granted during the year ended October 31,
−Removed: As of October 31, 2023, there was no
−Removed: unrecognized compensation cost related to market
−Removed: condition stock options granted to employees.
−Removed: recorded consulting expense, related to service-based stock options granted to consultants, during the years ended October 31, 2023 and
−Removed: 2022 of approximately $ 221,000
−Removed: and $ 434,000 ,
−Removed: respectively.
−Removed: Included in stock-based consulting expense for the years ended October 31, 2023 and 2022 was approximately $ 209,000
−Removed: and $ 434,000 ,
−Removed: respectively, related to compensation cost for stock options granted in prior periods but not yet vested.
+Added: non-financial assets that are measured at fair value on a non-recurring basis are property and equipment and other assets which are
+Added: measured using fair value techniques whenever events or changes in circumstances indicate a condition of impairment exists.
+Added: estimated fair value of prepaid expenses and other current assets, accounts payable and accrued expenses approximates their
+Added: individual carrying amounts due to the short-term nature of these measurements.
+Added: Cash equivalents are stated at carrying value which
+Added: approximates fair value.
+Added: Cash Equivalents
+Added: Cash equivalents consist of highly
+Added: liquid, short-term investments with maturities of three months or less when purchased.
+Added: Short-term Investments
+Added: At October 31, 2024 and 2023,
+Added: we had certificates of deposit and United States treasury bills with maturities greater than 90 days and less than 12 months when acquired
+Added: of approximately $ 18,653,000 and $ 22,929,000 , respectively, that were classified as short-term investments.
+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: Stock-Based Compensation
+Added: We maintain equity incentive plans
+Added: under which we may grant incentive stock options, non-qualified stock options, stock appreciation rights, stock awards, performance awards,
+Added: 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 (“ASC 718”).
+Added: the fair value of service-based stock options on the date of grant, using the Black-Scholes pricing model, and recognize compensation
+Added: expense over the requisite service period of the grant.
+Added: We recorded stock-based compensation
+Added: expense, related to service-based stock options granted to employees and directors, of approximately $ 4,420,000 and $ 4,422,000 , during
+Added: the years ended October 31, 2024 and 2023, respectively.
+Added: Included in stock-based compensation cost for service-based options granted to
+Added: employees and directors during the years ended October 31, 2024 and 2023 was approximately $ 3,187,000 and $ 3,023,000 , respectively, related
+Added: to the amortization of compensation cost for stock options granted in prior periods but not yet vested.
As of October 31, 2024, there
−Removed: was unrecognized consulting expense related to non-vested service-based stock options granted to consultants of approximately $ 281,000 ,
−Removed: which will be recognized over a weighted-average period of 2.5
−Removed: BIOSCIENCES, INC.
−Removed: AND SUBSIDIARIES
−Removed: TO CONSOLIDATED FINANCIAL STATEMENTS
−Removed: Value Determination
−Removed: use the Black-Scholes pricing model in estimating the fair value of stock options granted to employees, directors and consultants which
−Removed: vest over a specific period of time.
−Removed: The stock options we granted during each of the years ended October 31, 2023 and 2022 consisted
−Removed: of awards with 5 -year
−Removed: terms that vest over 12
−Removed: following weighted average assumptions were used in estimating the fair value of stock options granted during the years ended October
−Removed: 31, 2023 and 2022:
+Added: was unrecognized compensation cost related to non-vested service-based stock options granted to employees and directors of approximately
+Added: $ 4,843,000 , which will be recognized over a weighted-average period of 1.7 years.
+Added: We recorded consulting expense,
+Added: related to service-based stock options granted to consultants, during the years ended October 31, 2024 and 2023 of approximately $ 125,000
+Added: and $ 221,000 , respectively.
+Added: Included in stock-based consulting expense for the years ended October 31, 2024 and 2023 was approximately
+Added: $ 120,000 and $ 209,000 , respectively, related to compensation cost for stock options granted in prior periods but not yet vested.
+Added: October 31, 2024, there was unrecognized consulting expense related to non-vested service-based stock options granted to consultants of
+Added: approximately $ 180,000 , which will be recognized over a weighted-average period of 1.9 years.
+Added: Fair Value Determination
+Added: We use the Black-Scholes pricing
+Added: model in estimating the fair value of stock options granted to employees, directors and consultants which vest over a specific period
+Added: The stock options we granted during each of the years ended October 31, 2024 and 2023 consisted of awards with 5 -year and 10 -year
+Added: terms that vest over 12 to 36 months.
+Added: The following weighted average
+Added: assumptions were used in estimating the fair value of stock options granted during the years ended October 31, 2024 and 2023:
OF WEIGHTED AVERAGE ASSUMPTIONS USED IN ESTIMATING FAIR VALUE OF STOCK OPTIONS
−Removed: the Year Ended October 31,
−Removed: Weighted average fair value at
+Added: For the Year Ended October 31,
+Added: Weighted average fair value at grant date
Valuation assumptions:
3 unchanged sentences
Expected dividend yield
−Removed: expected term of stock options represents the weighted average period the stock options are expected to remain outstanding.
−Removed: For employees
−Removed: and directors, we use the simplified method, which is a weighted average of the vesting term and contractual term, to determine expected
−Removed: The simplified method was adopted since we do not believe that historical experience is representative of future performance because
−Removed: of the impact of the changes in our operations and the change in terms from historical operations.
−Removed: For consultants, we use the contract
−Removed: term for expected term.
−Removed: Under the Black-Scholes pricing model, we estimated the expected volatility of our shares of common stock based
−Removed: upon the historical volatility of our share price over a period of time equal to the expected term of the options.
−Removed: We estimated the risk-free
−Removed: interest rate based on the implied yield available on the applicable grant date of a U.S.
−Removed: Treasury note with a term equal to the expected
−Removed: term of the underlying grants.
−Removed: We made the dividend yield assumption based on our history of not paying cash dividends and our expectation
−Removed: not to pay dividends in the future.
−Removed: ASC 718, the amount of stock-based compensation expense recognized is based on the portion of the awards that are ultimately expected
−Removed: Accordingly, if deemed necessary, we reduce the fair value of the stock option awards for expected forfeitures, which are forfeitures
−Removed: of the unvested portion of surrendered options.
−Removed: Based on our historical experience and future expectations, we have not reduced the amount
−Removed: of stock-based compensation expenses for anticipated forfeitures.
−Removed: will reconsider use of the Black-Scholes pricing model if additional information becomes available in the future that indicates another
−Removed: model would be more appropriate.
−Removed: If factors change and we employ different assumptions in the application of ASC 718 in future periods,
−Removed: the compensation expense that we record under ASC 718 may differ significantly from what we have recorded in the current period.
−Removed: BIOSCIENCES, INC.
−Removed: AND SUBSIDIARIES
−Removed: TO CONSOLIDATED FINANCIAL STATEMENTS
−Removed: warrants granted to consultants for services rendered, we estimate the fair value using the Black-Scholes pricing model on the date of
−Removed: During the years ended October 31, 2023 and 2022 we recorded consulting expense, based on the fair value, of $ 0
−Removed: and approximately $ 221,000 ,
−Removed: respectively, for warrants granted to consultants.
−Removed: Loss Per Share of Common Stock
−Removed: accordance with ASC 260, Earnings Per Share, basic net loss per common share (“Basic EPS”) is computed by dividing net loss
−Removed: by the weighted average number of common shares outstanding.
−Removed: Diluted net loss per common share (“Diluted EPS”) is computed
−Removed: by dividing net loss by the weighted average number of common shares and dilutive common share equivalents and convertible securities
−Removed: then outstanding.
−Removed: Diluted EPS for all years presented is the same as Basic EPS, as the inclusion of the effect of common share equivalents
−Removed: then outstanding would be anti-dilutive.
−Removed: For this reason, excluded from the calculation of Diluted EPS for the years ended October 31,
−Removed: 2023 and 2022 were options to purchase 11,430,000
−Removed: shares and 10,318,872
−Removed: shares, respectively, and warrants to purchase
−Removed: shares and 300,000
−Removed: shares, respectively.
−Removed: preparation of financial statements in conformity with accounting principles generally accepted in the United States of America requires
+Added: The expected term of stock options
+Added: represents the weighted average period the stock options are expected to remain outstanding.
+Added: For employees and directors, we use the simplified
+Added: method, which is a weighted average of the vesting term and contractual term, to determine expected term.
+Added: The simplified method was adopted
+Added: since we do not believe that historical experience is representative of future performance because of the impact of the changes in our
+Added: operations and the change in terms from historical operations.
+Added: For consultants, we use the contract term for expected term.
+Added: Black-Scholes pricing model, we estimated the expected volatility of our shares of common stock based upon the historical volatility of
+Added: our share price over a period of time equal to the expected term of the options.
+Added: We estimated the risk-free interest rate based on the
+Added: implied yield available on the applicable grant date of a U.S.
+Added: Treasury note with a term equal to the expected term of the underlying
+Added: We made the dividend yield assumption based on our history of not paying cash dividends and our expectation not to pay dividends
+Added: in the future.
+Added: Under ASC 718, the amount of stock-based
+Added: compensation expense recognized is based on the portion of the awards that are ultimately expected to vest.
+Added: Accordingly, if deemed necessary,
+Added: we reduce the fair value of the stock option awards for expected forfeitures, which are forfeitures of the unvested portion of surrendered
+Added: Based on our historical experience and future expectations, we have not reduced the amount of stock-based compensation expenses
+Added: for anticipated forfeitures.
+Added: We will reconsider use of the
+Added: Black-Scholes pricing model if additional information becomes available in the future that indicates another model would be more appropriate.
+Added: If factors change and we employ different assumptions in the application of ASC 718 in future periods, the compensation expense that we
+Added: record under ASC 718 may differ significantly from what we have recorded in the current period.
+Added: Net Loss Per Share of Common Stock
+Added: In accordance with ASC 260, Earnings
+Added: Per Share, basic net loss per common share (“Basic EPS”) is computed by dividing net loss by the weighted average number of
+Added: common shares outstanding.
+Added: Diluted net loss per common share (“Diluted EPS”) is computed by dividing net loss by the weighted
+Added: average number of common shares and dilutive common share equivalents and convertible securities then outstanding.
+Added: Diluted EPS for all
+Added: years presented is the same as Basic EPS, as the inclusion of the effect of common share equivalents then outstanding would be anti-dilutive.
+Added: For this reason, excluded from the calculation of Diluted EPS for the years ended October 31, 2024 and 2023 were options to purchase 12,158,062
+Added: shares and 11,430,000 shares, respectively, and warrants to purchase 300,000 shares and 300,000 shares, respectively.
+Added: Use of Estimates
+Added: The preparation
+Added: of financial statements in conformity with accounting principles generally accepted in the United States of America requires
management to make estimates and assumptions that affect the reported amounts of assets and liabilities and disclosure of contingent
−Removed: assets and liabilities at the date of the financial statements and the reported amounts of revenues and expenses during the reporting
−Removed: Estimates and assumptions are used for, but not limited to, determining stock-based compensation, asset impairment evaluations,
−Removed: tax assets and liabilities, license fee revenue, the allowance for doubtful accounts, depreciation lives and other contingencies.
−Removed: results could differ from those estimates.
−Removed: BIOSCIENCES, INC.
−Removed: AND SUBSIDIARIES
−Removed: TO CONSOLIDATED FINANCIAL STATEMENTS
−Removed: of Recently Issued Pronouncements
−Removed: August 2020, the FASB issued Accounting Standards Update 2020-06 (“ASU 2020-06”), Accounting for Convertible Instruments
−Removed: and Contracts in an Entity’s Own Equity.
−Removed: The amendments in ASU 2020-06 include guidance on convertible instruments and the derivative
−Removed: scope exception for contracts in an entity’s own equity and simplifies the accounting for convertible instruments which include
−Removed: beneficial conversion features or cash conversion features by removing certain separation models in Subtopic 470-20.
−Removed: Additionally, ASU
−Removed: 2020-06 will require entities to use the “if-converted” method when calculating diluted earnings per share for convertible
−Removed: The amendments in this update are effective for fiscal years beginning after December 15, 2021, including interim periods
+Added: assets and liabilities at the date of the financial statements and the reported amounts of revenues and expenses during the
+Added: reporting period.
+Added: Estimates and assumptions are used for, but not limited to, determining stock-based compensation, asset impairment
+Added: evaluations, tax assets and liabilities, license fee revenue, research and development expense accruals, the allowance for doubtful
+Added: accounts, depreciation lives and other contingencies.
+Added: Actual results could differ from those estimates.
+Added: Effect of Recently Issued Pronouncements
+Added: In October 2021, the FASB issued
+Added: Accounting Standards Update 2021-08, Business Combinations (Topic 805):
+Added: Accounting for Contract Assets and
+Added: Contract Liabilities from Contracts with Customers, to require that an acquirer recognize and measure contract assets and contract liabilities
+Added: acquired in a business combination in accordance with Topic 606, Revenue from Contracts with Customers.
+Added: At the acquisition date, an acquirer
+Added: should account for the related revenue contracts in accordance with Topic 606 as if it had originated the contracts.
+Added: The amendments in
+Added: this update should be applied prospectively and are effective for fiscal years beginning after December 15, 2022, including interim periods
within those fiscal years.
−Removed: The adoption of this standard did not have a material impact on our consolidated financial statements and
−Removed: related disclosures.
−Removed: May 2021, the FASB issued Accounting Standards Update 2021-04 (“ASU 2021-04”), Issuer’s Accounting for Certain Modifications
−Removed: or Exchanges of Freestanding Equity-Classified Written Call Options.
−Removed: The guidance in ASU 2021-04 requires the issuer to treat a modification
−Removed: of an equity-classified written call option (the “option”) that does not cause the option to become liability-classified
−Removed: as an exchange of the original option for a new option.
−Removed: This guidance applies whether the modification is structured as an amendment
−Removed: to the terms and conditions of the option or as termination of the original option and issuance of a new option.
+Added: The adoption of this standard did not have a material impact on our consolidated financial statements and related
+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.
The amendments in this
−Removed: update are effective for fiscal years beginning after December 15, 2021, including interim periods within those fiscal years.
−Removed: of this standard did not have a material impact on our consolidated financial statements and related disclosures.
−Removed: October 2021, the FASB issued Accounting Standards Update 2021-08 (“ASU 2021-08”), Business Combinations (Topic 805):
−Removed: for Contract Assets and Contract Liabilities from Contracts with Customers, to require that an acquirer recognize and measure contract
−Removed: assets and contract liabilities acquired in a business combination in accordance with Topic 606, Revenue from Contracts with Customers.
−Removed: At the acquisition date, an acquirer should account for the related revenue contracts in accordance with Topic 606 as if it had originated
−Removed: the contracts.
−Removed: The amendments in this update should be applied prospectively and are effective for fiscal years beginning after December
−Removed: 15, 2022, including interim periods within those fiscal years.
−Removed: We do not expect the adoption of this standard to have a material impact
−Removed: on our consolidated financial statements and related disclosures.
−Removed: Concentration
−Removed: of Credit Risks
−Removed: instruments that potentially subject us to concentrations of credit risk are cash equivalents, short-term investments and accounts receivable.
−Removed: Cash equivalents are primarily highly rated money market funds.
−Removed: Short-term investments are certificates of deposit within federally insured
−Removed: limits as well as U.S.
+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: Concentration of Credit Risks
+Added: Financial instruments that potentially
+Added: subject us to concentrations of credit risk are cash equivalents, short-term investments and accounts receivable.
+Added: Cash equivalents are
+Added: primarily highly rated money market funds.
+Added: Short-term investments are U.S.
treasury bills.
−Removed: Where applicable, management reviews our accounts receivable and other receivables for potential
−Removed: doubtful accounts and maintains an allowance for estimated uncollectible amounts.
−Removed: Our policy is to write-off uncollectable amounts at
−Removed: the time it is determined that collection will not occur.
−Removed: One licensee accounted for 100% of revenues from patent licensing activities
−Removed: during fiscal year 2023.
+Added: Where applicable,
+Added: management reviews our accounts receivable and other receivables for potential doubtful accounts and maintains an allowance for estimated
+Added: uncollectible amounts.
+Added: Our policy is to write-off uncollectable amounts at the time it is determined that collection will not occur.
+Added: licensee accounted for 100 % of revenues from patent licensing activities during fiscal year 2023.
+Added: We recorded no revenue in fiscal year
ACCRUED EXPENSES
−Removed: liabilities consist of the following as of:
−Removed: OF ACCRUED EXPENSES
+Added: Accrued liabilities consist of
+Added: the following as of:
+Added: SCHEDULE OF ACCRUED EXPENSES
Payroll and related expenses
1 unchanged sentence
Accrued other
−Removed: BIOSCIENCES, INC.
−Removed: AND SUBSIDIARIES
−Removed: TO CONSOLIDATED FINANCIAL STATEMENTS
+Added: Accrued expenses
SHAREHOLDERS’ EQUITY
−Removed: the year ended October 31, 2023, we had two stock option plans:
+Added: Stock Option Plans
+Added: During the year ended October
+Added: 31, 2024, we had two stock option plans:
the Anixa Biosciences, Inc.
−Removed: 2010 Share Incentive Plan (the “2010
−Removed: Share Plan”) and the Anixa Biosciences, Inc.
−Removed: 2018 Share Incentive Plan (the “2018 Share Plan”) which were adopted by
−Removed: our Board of Directors on July 14, 2010 and January 25, 2018, respectively.
+Added: 2010 Share Incentive Plan (the “2010 Share Plan”) and
+Added: 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.
The 2018 Share Plan was approved by our shareholders on March 29, 2018.
−Removed: In accordance with the provisions of the 2010 Share Plan, the plan terminated with respect to the grant of future securities
−Removed: on July 14, 2020.
−Removed: the years ended October 31, 2023 and 2022, stock options to purchase 157,761
−Removed: shares of common stock, respectively, were exercised
−Removed: on a cash basis, with aggregate proceeds of approximately $ 353,000
−Removed: and $ 439,000 ,
−Removed: respectively.
−Removed: During the years ended October 31, 2023 and 2022, stock options to purchase 161,111
−Removed: shares of common stock, of which 116,225
−Removed: shares were withheld, and 1,488,881
−Removed: shares of common stock, of which 1,083,517
−Removed: shares were withheld, were exercised on a cashless
−Removed: basis, respectively.
−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: On the first business day of each calendar year the aggregate number of shares available
−Removed: for future issuance was replenished such that 800,000
−Removed: shares were available.
−Removed: The exercise price with
−Removed: respect to all of the options granted under the 2010 Share Plan was equal to the fair market value of the underlying common stock at
−Removed: the grant date.
−Removed: Information regarding the 2010 Share Plan for the two years ended October 31, 2023 is as follows:
+Added: In accordance
+Added: with the provisions of the 2010 Share Plan, the plan terminated with respect to the grant of future securities on July 14, 2020.
+Added: During the years ended October
+Added: 31, 2024 and 2023, stock options to purchase 173,031 and 157,761 shares of common stock, respectively, were exercised on a cash basis,
+Added: with aggregate proceeds of approximately $ 456,000 and $ 353,000 , respectively.
+Added: During the year ended October 31, 2023, stock options to
+Added: purchase 161,111 shares of common stock, of which 116,225 shares were withheld, were exercised on a cashless basis, respectively.
+Added: the year ended October 31, 2024, no stock options were exercised on a cashless basis.
+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: On the first business day of each calendar year the aggregate number of shares available for future issuance was replenished
+Added: such that 800,000 shares were available.
+Added: The exercise price with respect to all of the options granted under the 2010 Share Plan was equal
+Added: to the fair market value of the underlying common stock at the grant date.
+Added: Information regarding the 2010 Share Plan for the two years
+Added: ended October 31, 2024 is as follows:
OF OPTION ACTIVITY
+Added: Weighted Average
Exercise Price
−Removed: Intrinsic Value
+Added: Aggregate Intrinsic Value
Options Outstanding at October 31, 2022
Options Outstanding at October 31, 2023
−Removed: Options Outstanding
−Removed: and Exercisable at October 31, 2023
−Removed: following table summarizes information about stock options outstanding under the 2010 Share Plan as of October 31, 2023:
+Added: Options Outstanding and Exercisable at October 31, 2024
+Added: The following table summarizes
+Added: information about stock options outstanding under the 2010 Share Plan as of October 31, 2024:
OF OUTSTANDING AND EXERCISABLE
−Removed: of Exercise Prices
−Removed: BIOSCIENCES, INC.
−Removed: AND SUBSIDIARIES
−Removed: TO CONSOLIDATED FINANCIAL STATEMENTS
−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: On the first business day of each calendar year the maximum
−Removed: aggregate number of shares available for future issuance is replenished such that 2,000,000
−Removed: shares are available.
−Removed: The exercise price with
−Removed: respect to all of the options granted under the 2018 Share Plan was equal to the fair market value of the underlying common stock at
−Removed: the grant date.
−Removed: As of October 31, 2023, the 2018 Share Plan had 750,000
−Removed: shares available for future grants.
−Removed: regarding the 2018 Share Plan for the two years ended October 31, 2023 is as follows:
+Added: Range of Exercise Prices
+Added: Outstanding and
+Added: Weighted Average
+Added: Contractual Life
+Added: Exercise Price
+Added: $ 0.67 - $ 2.27
+Added: $ 2.58 - $ 3.13
+Added: $ 3.46 - $ 5.30
+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: On the first business day of each calendar year the maximum aggregate number of shares
+Added: available for future issuance is replenished such that 2,000,000 shares are available.
+Added: The exercise price with respect to all of the options
+Added: granted under the 2018 Share Plan was equal to the fair market value of the underlying common stock at the grant date.
+Added: As of October 31,
+Added: 2024, the 2018 Share Plan had 983,907 shares available for future grants.
+Added: Information regarding the 2018 Share Plan for the two years
+Added: ended October 31, 2024 is as follows:
OF OPTION ACTIVITY
+Added: Weighted Average
Exercise Price
−Removed: Intrinsic Value
+Added: Aggregate Intrinsic Value
Options Outstanding at October 31, 2022
+Added: Forfeited/Expired
Options Outstanding at October 31, 2023
Forfeited/Expired
+Added: Options Outstanding at October 31, 2024
+Added: Options Exercisable at October 31, 2024
+Added: The following table summarizes
+Added: information about stock options outstanding under the 2018 Share Plan as of October 31, 2024:
+Added: OF OUTSTANDING AND EXERCISABLE
Options Outstanding
−Removed: at October 31, 2023
Options Exercisable
−Removed: at October 31, 2023
−Removed: following table summarizes information about stock options outstanding under the 2018 Share Plan as of October 31, 2023:
−Removed: OF OUTSTANDING AND EXERCISABLE
−Removed: addition to options granted under stock option plans, during the years ended October 31, 2012 and 2013, the Board of Directors approved
−Removed: the grant of stock options to certain employees and directors (the “Non-Plan Options”).
−Removed: BIOSCIENCES, INC.
−Removed: AND SUBSIDIARIES
−Removed: TO CONSOLIDATED FINANCIAL STATEMENTS
−Removed: regarding the Non-Plan Options for the two years ended October 31, 2023 is as follows:
−Removed: OF OPTION ACTIVITY
+Added: Exercise Prices
+Added: Contractual Life
Exercise Price
−Removed: Options Outstanding October 31,
+Added: Contractual Life
+Added: Exercise Price
$ 2.09 - $ 3.87
−Removed: Options Outstanding
−Removed: and Exercisable at October 31, 2022
−Removed: Stock Purchase Plan
−Removed: Company maintains the Anixa Biosciences, Inc.
−Removed: Employee Stock Purchase Plan which permits eligible employees to purchase shares at not
−Removed: less than 85 %
−Removed: of the market value of the Company’s common stock on the offering date or the purchase date of the applicable offering period,
−Removed: whichever is lower.
−Removed: The plan was adopted by our Board of Directors on August 13, 2018 and approved by our shareholders on September 27,
−Removed: During the years ended October 31, 2023 and 2022, employees purchased 4,360
−Removed: shares, respectively, with aggregate proceeds
−Removed: of approximately $ 13,000
−Removed: and $ 13,000 ,
−Removed: respectively.
−Removed: Stock Purchase Warrants
−Removed: November 1, 2021 we issued a warrant, expiring on October
−Removed: 30, 2026 , to purchase 60,000
−Removed: shares of common stock at $ 4.77
−Removed: per share, vesting over five
−Removed: months , to a consultant for investor relations
−Removed: We recorded consulting expense of approximately $ 221,000
−Removed: during the year ended October 31, 2022, based
−Removed: on the fair value of the warrant recognized on a straight-line basis over the vesting period.
−Removed: The warrant terminated in May 2022 upon
−Removed: termination of the consulting agreement.
−Removed: connection with a public offering in March 2021, we issued to certain designees of the underwriter, as compensation, warrants to purchase
−Removed: shares of common stock at $ 6.5625
−Removed: per share, expiring on March
−Removed: regarding the Company’s warrants for the two years ended October 31, 2023 is as follows:
+Added: $ 3.96 - $ 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 years ended October 31, 2024 and 2023, employees purchased 3,986 and 4,360 shares, respectively, with aggregate proceeds
+Added: of approximately $ 10,000 and $ 13,000 , respectively.
+Added: Common Stock Purchase Warrants
+Added: In connection with a public offering
+Added: in March 2021, we issued to certain designees of the underwriter, as compensation, warrants to purchase 300,000 shares of common stock
+Added: at $ 6.5625 per share, expiring on March 22, 2026 .
+Added: Information regarding the Company’s
+Added: warrants for the two years ended October 31, 2024 is as follows:
OF WARRANTS ACTIVITY
+Added: Weighted Average
Exercise Price
−Removed: Warrants Outstanding at October
−Removed: Warrants Outstanding
−Removed: and Exercisable at October 31, 2022 and October 31, 2023
−Removed: following table summarizes information about the Company’s outstanding and exercisable warrants as of October 31 , 2023:
+Added: Warrants Outstanding and Exercisable at October 31, 2023 and October 31, 2024
+Added: The following table summarizes
+Added: information about the Company’s outstanding and exercisable warrants as of October 31 , 2024:
OF OUTSTANDING AND EXERCISABLE
−Removed: BIOSCIENCES, INC.
−Removed: AND SUBSIDIARIES
−Removed: TO CONSOLIDATED FINANCIAL STATEMENTS
−Removed: lease approximately 2,000
−Removed: square feet of office space at 3150 Almaden Expressway,
−Removed: San Jose, California (our principal executive offices) from an unrelated party pursuant to an operating lease that, as amended, will
−Removed: expire on September
−Removed: 30, 2024 , with an
−Removed: option to extend the lease an additional two years.
−Removed: base rent is approximately $ 5,000
−Removed: per month and the lease provides for annual increases
−Removed: of approximately 3 %
−Removed: 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 $ 260,000
+Added: Exercise Price
+Added: Outstanding and
+Added: Weighted Average
+Added: Contractual Life
+Added: Exercise Price
+Added: During the years ended October
+Added: 31, 2024 and 2023, we issued 89,336 shares and 24,310 shares of common stock, respectively, to consultants providing investor relations
+Added: services and recorded expense of approximately $ 237,000 and $ 92,000 , respectively.
+Added: As of October 31, 2024 and 2023, approximately $ 18,000
+Added: and $ 0 , respectively, was recorded as a prepaid expense.
+Added: Treasury stock
+Added: As of October 31, 2024, the Company
+Added: held 2,000 shares of its common stock as treasury stock.
+Added: These shares were repurchased at an average cost of $ 3.17 per share for a total
+Added: cost of approximately $ 6,000 .
+Added: The repurchases were made as part of a stock buyback program approved by our Board of Directors on July
+Added: The treasury shares are accounted for under the cost method and are recorded as a reduction in shareholders’ equity in
+Added: the consolidated balance sheet.
+Added: The Company may reissue treasury shares for stock option exercises, acquisitions, or other corporate purposes.
+Added: We lease approximately 2,000 square
+Added: feet of office space at 3150 Almaden Expressway, San Jose, California 95118 (our principal executive offices) from an unrelated party
+Added: pursuant to an operating lease that, as amended, will expire on September 30, 2027 , with an option to extend the lease an additional two
+Added: The base rent is approximately $ 5,000 per month and the lease provides for annual increases of approximately 3 % and an escalation
+Added: clause for increases in certain operating costs.
+Added: The lease, as amended, resulted in a right-of-use asset and lease liability of approximately
$ 250,000 with a discount rate of 12 %.
−Removed: Rent expense was approximately $ 66,000 for
−Removed: each of the years ended October 31, 2023 and 2022.
−Removed: operating leases, the lease liability is initially and subsequently measured at the present value of the unpaid lease payments.
−Removed: The remaining
−Removed: lease term as of October 31, 2023 for the Company’s lease includes the noncancelable period of the lease and the additional two-year
−Removed: option period that the Company believes it is reasonably certain to exercise.
−Removed: All right-of-use assets are reviewed for impairment when
−Removed: indications of impairment are present.
−Removed: of October 31, 2023, the annual minimum lease payments of our operating lease liability were as follows (in thousands):
−Removed: OF MINIMUM LEASE PAYMENTS
+Added: Rent expense was approximately $ 61,000 and $ 66,000 for the years ended October 31, 2024 and 2023,
+Added: respectively.
+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 59 -month lease term
+Added: as of October 31, 2024 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 October 31, 2024, the annual
+Added: minimum lease payments of our operating lease liability were as follows (in thousands):
+Added: SCHEDULE OF MINIMUM LEASE PAYMENTS
For Years Ending October 31,
−Removed: Total future minimum lease
−Removed: payments, undiscounted
+Added: Operating Leases
+Added: Total future minimum lease payments, undiscounted
Imputed interest
−Removed: value of future minimum lease payments
+Added: Present value of future minimum lease payments
+Added: Balance as of October 31, 2024
+Added: Operating lease liability
+Added: Operating lease liability, non-current
COMMITMENTS AND CONTINGENCIES
−Removed: than lawsuits we bring to enforce our patent rights, we are not involved in any litigation or other legal proceedings and management
−Removed: is not 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 October 31, 2023, our commitments under the license agreements with Wistar and Cleveland Clinic for the year ending October 31, 2024
−Removed: were approximately $ 70,000 .
−Removed: & Development Agreements
−Removed: have entered into certain research and development agreements with various third-party vendors related to the manufacturing of materials
−Removed: necessary for the expected Phase 2 clinical trial of our breast cancer vaccine.
−Removed: As of October 31, 2023, future payments the Company may
−Removed: make under these agreements may be approximately $ 3.5 million and such payments may be made over up to a five-year period.
−Removed: tax provision (benefit) consists of the following:
+Added: Litigation Matters
+Added: Other than lawsuits we bring to
+Added: enforce our patent rights, we are not involved in any litigation or other legal proceedings and management is not aware of any pending
+Added: litigation 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 October 31, 2024, 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 October 31, 2024, 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 $ 4.2 million and such payments may be made over up to a
+Added: five-year period.
+Added: Income tax provision (benefit)
+Added: consists of the following:
OF INCOME TAX PROVISION (BENEFIT)
−Removed: Ended October 31,
−Removed: ( 1,739,000 )
+Added: Year Ended October 31,
( 2,284,000 )
−Removed: Adjustment to valuation
−Removed: allowance related to net deferred tax assets
−Removed: BIOSCIENCES, INC.
−Removed: AND SUBSIDIARIES
−Removed: TO CONSOLIDATED FINANCIAL STATEMENTS
−Removed: tax effects of temporary differences that give rise to significant portions of the deferred tax asset, net, at October 31, 2023 and 2022,
−Removed: are as follows:
+Added: Adjustment to valuation allowance related to net deferred tax assets
+Added: The tax effects of temporary differences
+Added: that give rise to significant portions of the deferred tax asset, net, at October 31, 2024 and 2023, are as follows:
OF DEFERRED TAX ASSETS AND LIABILITIES
Long-term deferred tax assets:
−Removed: state NOL and tax credit carryforwards
+Added: Federal and state NOL and tax credit carryforwards
Deferred compensation
2 unchanged sentences
( 34,502,000 )
−Removed: tax asset, net
−Removed: of October 31, 2023, we had Federal tax net operating loss and tax credit carryforwards of approximately $ 95,752,000
−Removed: and $ 1,870,000 ,
−Removed: respectively.
−Removed: At the federal level, businesses can carry forward their net operating losses indefinitely, but the deductions are limited
−Removed: to 80 percent of taxable income.
−Removed: Prior to the Tax Cuts and Jobs Act (TCJA) of 2017, businesses could carry losses forward for 20 years
−Removed: (without a deductibility limit).
−Removed: If the tax benefits relating to deductions of option holders’ income are ultimately realized,
−Removed: those benefits will be credited directly to additional paid-in capital.
−Removed: Certain changes in stock ownership can result in a limitation
−Removed: on the amount of net operating loss and tax credit carryovers that can be utilized each year.
−Removed: As of October 31, 2023, management has
−Removed: not determined the extent of any such limitations, if any.
−Removed: had California tax net operating loss carryforwards of approximately $ 51,065,000
−Removed: as of October 31, 2023, available within statutory
−Removed: limits ( expiring
−Removed: at various dates between 2024 and 2043 ), to offset
−Removed: future corporate taxable income and taxes payable, if any, under certain computations of such taxes.
−Removed: have provided a 100 %
−Removed: valuation allowance against our deferred tax
−Removed: asset due to our current and historical pre-tax losses and the uncertainty regarding their realizability.
−Removed: The primary differences from
−Removed: the Federal statutory rate of 21 %
−Removed: and the effective rate of 0 %
−Removed: is attributable to expiring net operating losses and a change in the valuation allowance.
−Removed: The following is a reconciliation of income
−Removed: taxes at the Federal statutory tax rate to income tax expense (benefit):
+Added: Deferred tax asset, net
+Added: As of October 31, 2024, we had
+Added: Federal tax net operating loss and tax credit carryforwards of approximately $ 99,868,000 and $ 1,946,000 , respectively.
+Added: At the federal
+Added: level, businesses can carry forward their net operating losses indefinitely, but the deductions are limited to 80 percent of taxable income.
+Added: Prior to the Tax Cuts and Jobs Act (TCJA) of 2017, businesses could carry losses forward for 20 years (without a deductibility limit).
+Added: If the tax benefits relating to deductions of option holders’ income are ultimately realized, those benefits will be credited directly
+Added: to additional paid-in capital.
+Added: Certain changes in stock ownership can result in a limitation on the amount of net operating loss and tax
+Added: credit carryovers that can be utilized each year.
+Added: As of October 31, 2024, management has not determined the extent of any such limitations,
+Added: We had California tax net operating
+Added: loss carryforwards of approximately $ 60,618,000 as of October 31, 2024, available within statutory limits ( expiring at various dates between
+Added: 2025 and 2044 ), to offset future corporate taxable income and taxes payable, if any, under certain computations of such taxes.
+Added: We have provided a 100 % valuation
+Added: allowance against our deferred tax asset due to our current and historical pre-tax losses and the uncertainty regarding their realizability.
+Added: The primary differences from the Federal statutory rate of 21 % and the effective rate of 0 % is attributable to a change in the valuation
+Added: The following is a reconciliation of income taxes at the Federal statutory tax rate to income tax expense (benefit):
OF RECONCILIATION OF INCOME TAXES
−Removed: Ended October 31,
+Added: Year Ended October 31,
Income tax benefit at U.S.
−Removed: statutory income tax rate
+Added: Federal statutory income tax rate
$ ( 2,667,000 )
2 unchanged sentences
Permanent differences
−Removed: Expiring net operating losses, credits and
−Removed: Change in valuation
−Removed: tax provision
−Removed: BIOSCIENCES, INC.
−Removed: AND SUBSIDIARIES
−Removed: TO CONSOLIDATED FINANCIAL STATEMENTS
−Removed: the two fiscal years ended October 31, 2023, we incurred no Federal and no State income taxes.
−Removed: unrecognized tax benefits as of October 31, 2023
−Removed: and 2022 and we account for interest and penalties related to income tax matters in general and administrative expenses.
−Removed: which our net operating losses relate remain open to examination by Federal and California authorities to the extent which the net operating
−Removed: losses have yet to be utilized.
+Added: Expiring net operating losses, credits and other
+Added: Change in valuation allowance
+Added: Income tax provision
+Added: During the two fiscal years ended
+Added: October 31, 2024, we incurred no Federal and no State income taxes.
+Added: We have no unrecognized tax benefits as of October 31, 2024 and 2023
+Added: and we account for interest and penalties related to income tax matters in general and administrative expenses.
+Added: Tax years to which our
+Added: net operating losses relate remain open to examination by Federal and California authorities to the extent which the net operating losses
+Added: have yet to be utilized.
SEGMENT INFORMATION
−Removed: follow the accounting guidance of ASC 280, Segment Reporting (“ASC 280”).
−Removed: Reportable operating segments are determined based
−Removed: on the management approach.
−Removed: The management approach, as defined by ASC 280, is based on the way that the chief operating decision-maker
−Removed: organizes the segments within an enterprise for making operating decisions and assessing performance.
−Removed: While our results of operations
−Removed: are primarily reviewed on a consolidated basis, the chief operating decision-maker manages the enterprise in four
−Removed: reportable segments, each with different operating
−Removed: and potential revenue generating characteristics:
−Removed: (i) CAR-T Therapeutics, (ii) Cancer Vaccines, (iii) Anti-Viral Therapeutics and (iv)
−Removed: The following represents selected financial information for our segments for the years ended October 31, 2023 and 2022:
+Added: We follow the accounting guidance
+Added: of ASC 280, Segment Reporting (“ASC 280”).
+Added: Reportable operating segments are determined based on the management approach.
+Added: The management approach, as defined by ASC 280, is based on the way that the chief operating decision-maker organizes the segments within
+Added: an enterprise for making operating decisions and assessing performance.
+Added: While our results of operations are primarily reviewed on a consolidated
+Added: basis, the chief operating decision-maker manages the enterprise in three reportable segments, each with different operating and potential
+Added: revenue generating characteristics:
+Added: (i) Cancer Vaccines, (ii) CAR-T Therapeutics, and (iii) Other.
+Added: The following represents selected financial
+Added: information for our segments for the years ended October 31, 2024 and 2023, in thousands:
OF SEGMENT INFORMATION
−Removed: Ended October 31,
−Removed: Net income (loss):
−Removed: CAR-T Therapeutics
+Added: Year Ended October 31,
Cancer Vaccines
−Removed: Anti-Viral Therapeutics
−Removed: income (loss)
−Removed: Total operating costs and expenses
−Removed: Less non-cash share-based
−Removed: costs and expenses excluding non-cash share-based compensation
−Removed: Operating costs and expenses excluding non-cash
−Removed: share based compensation:
CAR-T Therapeutics
+Added: Net income (loss)
+Added: Total operating costs and expenses
+Added: Less non-cash stock-based compensation
+Added: Operating costs and expenses excluding non-cash stock-based compensation
+Added: Operating costs and expenses excluding non-cash stock-based compensation:
Cancer Vaccines
−Removed: Anti-Viral Therapeutics
+Added: CAR-T Therapeutics
costs and expenses excluding non-cash share based compensation
Total assets:
−Removed: CAR-T Therapeutics
Cancer Vaccines
−Removed: Anti-Viral Therapeutics
−Removed: costs and expenses excluding non-cash share-based compensation is the measurement the chief operating decision-maker uses in managing
−Removed: the enterprise.
−Removed: Company’s consolidated revenue of $ 210,000
−Removed: and inventor royalties, contingent legal fees, litigation and
−Removed: licensing expense of $ 161,000 ,
−Removed: for the year ended October 31, 2023 were solely related to our other segment.
−Removed: All our revenue is generated domestically (United States)
−Removed: 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.
+Added: The Company had no revenue during
+Added: the year ended October 31, 2024.
+Added: The Company’s consolidated revenue of $ 210,000 and inventor royalties, contingent legal fees, litigation
+Added: and licensing expense of $ 161,000 , for the year ended October 31, 2023 were solely related to our other segment.
+Added: All our revenue is generated
+Added: domestically (United States) based on the country in which the licensee is located.
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.