2 unchanged sentences
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 President, Chief Operating Officer
−Removed: and Chief Financial Officer, we evaluated the effectiveness of the design and operation of our disclosure controls and procedures pursuant
−Removed: to Rule 13a-15 and 15d-15 of the Exchange Act.
−Removed: Based upon that evaluation, our Chief Executive Officer and our President, Chief Operating
−Removed: Officer and Chief Financial Officer concluded that our disclosure controls and procedures were effective as of the end of fiscal year
+Added: supervision and with the participation of our management, including our Chief Executive Officer and our Chief Financial Officer, we evaluated
+Added: the effectiveness of the design and operation of our disclosure controls and procedures pursuant to Rule 13a-15 and 15d-15 of the Exchange
+Added: Based upon that evaluation, our Chief Executive Officer and our Chief Financial Officer concluded that our disclosure controls and
+Added: procedures were effective as of the end of fiscal year 2023.
Report on Internal Control Over Financial Reporting
17 unchanged sentences
Management’s report was not subject to attestation by the Company’s independent registered
−Removed: public accounting firm pursuant to a permanent exemption of the Commission that permits the Company to provide only management’s
−Removed: report in this Annual Report on Form 10-K.
−Removed: Accordingly, our management’s assessment of the effectiveness of our internal control
−Removed: over financial reporting as of October 31, 2022 has not been audited by our auditors, Haskell & White LLP.
+Added: public accounting firm pursuant to an exemption of the Commission that permits smaller reporting companies and non-accelerated filers,
+Added: such as the Company, to provide only management’s report in this Annual Report on Form 10-K.
+Added: Accordingly, our management’s
+Added: assessment of the effectiveness of our internal control over financial reporting as of October 31, 2023 has not been audited by our auditors,
+Added: Haskell & White LLP.
in Internal Control Over Financial Reporting
25 unchanged sentences
accompanying “Index to Consolidated Financial Statements.”
−Removed: Certificate 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 February 11, 2014.)
−Removed: Amendment to the Certificate of Incorporation.
+Added: 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
+Added: February 11, 2014.)
+Added: to the Certificate of Incorporation.
(Incorporated by reference to Exhibit 3.2 to our Form 10-K for the fiscal year ended October
−Removed: Certificate of Amendment to the Certificate of Incorporation.
−Removed: (Incorporated by reference to Exhibit 3.1 to our Form 8-K, dated September 4, 2014.)
−Removed: Certificate of Designations, Preferences and Rights of Series A Convertible Preferred Stock.
+Added: of Amendment to the Certificate of Incorporation.
(Incorporated by reference to Exhibit 3.1 to our Form 8-K, dated September 4, 2014.)
−Removed: Certificate of Amendment to the Certificate of Incorporation.
+Added: of Designations, Preferences and Rights of Series A Convertible Preferred Stock.
+Added: (Incorporated by reference to Exhibit 3.1 to our
+Added: Form 8-K, dated September 10, 2014.)
+Added: of Amendment to the Certificate of Incorporation.
(Incorporated by reference to Exhibit 3.1 to our Form 8-K, dated June 25, 2015.)
−Removed: Certificate of Amendment to the Certificate of Incorporation.
−Removed: (Incorporated by reference to Exhibit 3.1 to our Form 10-Q for the fiscal quarter ended April 30, 2018.)
−Removed: Certificate of Amendment to the Certificate of Incorporation.
+Added: of Amendment to the Certificate of Incorporation.
+Added: (Incorporated by reference to Exhibit 3.1 to our Form 10-Q for the fiscal quarter
+Added: ended April 30, 2018.)
+Added: of Amendment to the Certificate of Incorporation.
(Incorporated by reference to Exhibit 3.1 to our Form 8-K, dated October 1, 2018.)
−Removed: Certificate of Amendment to the Certificate of Incorporation.
+Added: of Amendment to the Certificate of Incorporation.
(Incorporated by reference to Exhibit 3.1 to our Form 8-K, dated August 13, 2020.)
−Removed: Amended and Restated By-laws.
+Added: 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: Amendment to the Amended and Restated Bylaws of the Company.
+Added: to the Amended and Restated Bylaws of the Company.
(Incorporated by reference to our Form 8-K, dated April 2, 2021.)
−Removed: Form of Underwriter Warrants.
+Added: of Underwriter Warrants.
(Incorporated by reference to Exhibit 4.1 to our Form 8-K, dated March 24, 2021.)
−Removed: 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.)
+Added: of the Company’s Securities Registered under Section 12 of the Exchange Act (Incorporated by reference to the description of
+Added: our common stock contained in our Current Report on Form 8-K filed on March 31, 2014.)
Share Incentive Plan.
(Incorporated by reference to Exhibit 10.1 to our Form 8-K, dated July 20, 2010.)
−Removed: 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.)
−Removed: 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.)
−Removed: 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 January 31, 2014.)
+Added: (Incorporated by reference to Exhibit 10.1 to our Form 10-Q for the fiscal quarter ended
+Added: January 31, 2014.)
Share Incentive Plan.
(Incorporated by reference to Exhibit 4.13 to our Form S-8 dated October 1, 2018.)
−Removed: License Agreement, dated November 13, 2017, between Certainty Therapeutics, Inc.
+Added: Agreement, dated November 13, 2017, between Certainty Therapeutics, Inc.
and The Wistar Institute of Anatomy and Biology.
−Removed: (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.
+Added: (Incorporated
+Added: by reference to Exhibit 10.14 to our Form 10-K, dated January 9, 2018.) (Portions of this exhibit have been redacted pursuant to
+Added: a request for confidential treatment.
The redacted portions have been separately filed with the Securities and Exchange Commission.)
−Removed: Amendment to License Agreement between Certainty Therapeutics, Inc.
+Added: to License Agreement between Certainty Therapeutics, Inc.
and The Wistar Institute of Anatomy and Biology.
−Removed: (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.)
−Removed: Amended and Restated Master Collaboration Agreement, dated November 1, 2021, between Certainty Therapeutics, Inc.
−Removed: Lee Moffitt Cancer Center and Research Institute, Inc.
−Removed: (Incorporated by reference to Exhibit 10.8 to our Form 10-K for the fiscal year ended October 31, 2021.)
−Removed: Exclusive License Agreement, dated July 8, 2019, between the Company and The Cleveland Clinic Foundation.
−Removed: (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.)
−Removed: Collaboration Agreement, dated April 14, 2020, between the Company and OntoChem GmbH.
−Removed: (Incorporated by reference to Exhibit 10.1 to our Form 10-Q for the fiscal quarter ended April 30, 2020.) (Certain information has been redacted in the marked portions of the exhibit.)
−Removed: Amendment to Collaboration Agreement between the Company and OntoChem GmbH.
+Added: (Incorporated by reference
+Added: 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
+Added: portions of the exhibit.)
+Added: and Restated Master Collaboration Agreement, dated November 1, 2021, between Certainty Therapeutics, Inc.
+Added: Lee Moffitt Cancer
+Added: Center and Research Institute, Inc.
(Incorporated by reference to Exhibit 10.8 to our Form 10-K for the fiscal year ended October
−Removed: Assignment Agreement dated May 1, 2021, between the Company, OntoChem GmbH and MolGenie GmbH.
−Removed: (Incorporated by reference to Exhibit 10.1 to our Form 10-Q for the fiscal quarter ended April 30, 2021.)
−Removed: Amendment 2 to the Collaboration Agreement between the Company and MolGenie GmbH.
−Removed: (Incorporated by reference to Exhibit 10.2 to our Form 10-Q for the fiscal quarter ended April 30, 2021.) (Certain information has been redacted in the marked portions of the exhibit.)
−Removed: Exclusive License Agreement, dated October 20, 2020, between the Company and The Cleveland Clinic Foundation.
−Removed: (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.)
−Removed: Amendment No.
+Added: License Agreement, dated July 8, 2019, between the Company and The Cleveland Clinic Foundation.
+Added: (Incorporated by reference to Exhibit
+Added: 10.1 to our Form 10-Q for the fiscal quarter ended July 31, 2019.) (Certain information has been redacted in the marked portions
+Added: of the exhibit.)
to Exclusive License Agreement between the Company and The Cleveland Clinic Foundation.
−Removed: (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.)
−Removed: Joint Development and Option Agreement, dated January 26, 2021, between the Company and The Cleveland Clinic Foundation.
−Removed: (Incorporated by reference to Exhibit 10.2 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.)
−Removed: Form of Controlled Equity Offering SM Sales Agreement (Incorporated by reference to Exhibit 10.1 to our Form S-3 dated September 9, 2022)
−Removed: Code of Conduct (Incorporated by reference to Exhibit 14 to our Form 10-K, for the fiscal year ended October 31, 2020.)
−Removed: Subsidiaries of Anixa Biosciences, Inc.
+Added: (Filed herewith.)
+Added: License Agreement, dated October 20, 2020, between the Company and The Cleveland Clinic Foundation.
+Added: (Incorporated by reference to
+Added: Exhibit 10.14 to our Form 10-K, for the fiscal year ended October 31, 2020.) (Certain information has been redacted in the marked
+Added: portions of the exhibit.)
+Added: 1 to Exclusive License Agreement between the Company and The Cleveland Clinic Foundation.
+Added: (Incorporated by reference to Exhibit
+Added: 10.1 to our Form 10-Q for the fiscal quarter ended July 31, 2022.) (Certain information has been redacted in the marked portions
+Added: of the exhibit.)
+Added: of Controlled Equity Offering SM Sales Agreement (Incorporated by reference to Exhibit 10.1 to our Form S-3 dated September
+Added: of Conduct (Incorporated by reference to Exhibit 14 to our Form 10-K, for the fiscal year ended October 31, 2020.)
+Added: Trading Policy (Filed herewith.)
+Added: of Anixa Biosciences, Inc.
(Incorporated by reference to Exhibit 21 to our Form 10-K, for the fiscal year ended October 31, 2020.)
−Removed: Consent of Haskell & White LLP.
+Added: of Haskell & White LLP.
(Filed herewith.)
−Removed: Certification of Chief Executive Officer, pursuant to Section 302 of the Sarbanes-Oxley Act of 2002, dated January 4, 2023.
+Added: Certification
+Added: of Chief Executive Officer, pursuant to Section 302 of the Sarbanes-Oxley Act of 2002, dated January 16, 2024.
(Filed herewith.)
−Removed: Certification of Chief Financial Officer, pursuant to Section 302 of the Sarbanes-Oxley Act of 2002, dated January 4, 2023.
+Added: Certification
+Added: of Chief Financial Officer, pursuant to Section 302 of the Sarbanes-Oxley Act of 2002, dated January 16, 2024.
(Filed herewith.)
−Removed: Statement of Chief Executive Officer, pursuant to Section 1350 of Title 18 of the United States Code, dated January 4, 2023.
+Added: of Chief Executive Officer, pursuant to Section 1350 of Title 18 of the United States Code, dated January 16, 2024.
(Filed herewith.)
−Removed: Statement of Chief Financial Officer, pursuant to Section 1350 of Title 18 of the United States Code, dated January 4, 2023.
+Added: of Chief Financial Officer, pursuant to Section 1350 of Title 18 of the United States Code, dated January 16, 2024.
(Filed herewith.)
+Added: Policy (Filed herewith.)
Form 10-K Summary.
12 unchanged sentences
Financial Officer
−Removed: Accounting Officer)
+Added: Financial and Accounting Officer)
Titterton, Jr.
7 unchanged sentences
of Independent Registered Public Accounting Firm (PCAOB ID:
−Removed: Consolidated Balance Sheets as of October 31, 2022 and 2021
−Removed: Consolidated Statements of Operations for the years ended October 31, 2022 and 2021
−Removed: Consolidated Statements of Equity for the years ended October 31, 2022 and 2021
−Removed: Consolidated Statements of Cash Flows for the years ended October 31, 2022 and 2021
−Removed: Notes to Consolidated Financial Statements
+Added: Balance Sheets as of October 31, 2023 and 2022
+Added: Statements of Operations for the years ended October 31, 2023 and 2022
+Added: Statements of Equity for the years ended October 31, 2023 and 2022
+Added: Statements of Cash Flows for the years ended October 31, 2023 and 2022
+Added: to Consolidated Financial Statements
information required by schedules called for under Regulation S-X is either not applicable or is included in the consolidated financial
4 unchanged sentences
on the Consolidated Financial Statements
−Removed: We have audited the accompanying consolidated balance sheets of Anixa Biosciences,
−Removed: (the “Company”) as of October 31, 2022 and 2021, and the related consolidated statements of operations, equity, and cash
−Removed: flows for each of the two years in the period ended October 31, 2022, and the related notes (collectively, the “consolidated financial
−Removed: statements”).
−Removed: In our opinion, the consolidated financial statements present fairly, in all material respects, the consolidated financial
−Removed: position of the Company as of October 31, 2022 and 2021, and the consolidated results of its operations and its cash flows for each of
−Removed: the years in the two year period ended October 31, 2022, in conformity with accounting principles generally accepted in the United States
+Added: have audited the accompanying consolidated balance sheets of Anixa Biosciences, Inc.
+Added: (the “Company”) as of October 31, 2023
+Added: and 2022, and the related consolidated statements of operations, equity, and cash flows for each of the two years in the period ended
+Added: October 31, 2023, and the related notes (collectively, the “consolidated financial statements”).
+Added: In our opinion, the consolidated
+Added: financial statements present fairly, in all material respects, the consolidated financial position of the Company as of October 31, 2023
+Added: 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
+Added: 31, 2023, in conformity with accounting principles generally accepted in the United States of America.
consolidated financial statements are the responsibility of the Company’s management.
20 unchanged sentences
Audit Matters
−Removed: Critical audit matters are matters arising from the current period audit
−Removed: of the consolidated financial statements that were communicated or required to be communicated to the audit committee and that:
−Removed: to accounts or disclosures that are material to the consolidated financial statements and (2) involved our especially challenging, subjective,
−Removed: or complex judgments.
−Removed: We determined that there were no critical audit matters.
+Added: critical audit matter communicated below is a matter arising from the current period audit of the consolidated financial statements
+Added: that was communicated or required to be communicated to the audit committee and that:
+Added: (1) relate to accounts or disclosures that are
+Added: material to the consolidated financial statements and (2) involved our especially challenging, subjective, or complex
+Added: The communication of critical audit matters does not alter in any way our opinion on the consolidated financial
+Added: statements, taken as a whole, and we are not, by communicating the critical audit matter below, providing separate opinions on the critical
+Added: audit matter or on the accounts or disclosures to which it relates.
+Added: and Development Expenses – Refer to Note 2 of the Consolidated Financial Statements
+Added: Audit Matter Description:
+Added: Company recognizes research and development expenses as incurred.
+Added: Advance payments for future research and development activities are
+Added: deferred and expensed as the services are performed.
+Added: The Company recognizes its preclinical studies and clinical trial expenses based
+Added: on the services performed pursuant to contracts with research institutions, clinical research organizations (“CROs”), clinical
+Added: manufacturing organizations (“CMOs”), and other parties that conduct and manage various stages of research and development
+Added: activities on the Company’s behalf.
+Added: Fees for such services are recognized based on management’s estimates after considering
+Added: the activities and tasks completed by each service provider in a given period, the time period over which services are expected to be
+Added: performed, and the level of effort expended in each reporting period.
+Added: each balance sheet date, management estimates prepaid and accrued research and development costs by discussing progress or stage of completion
+Added: of activities with internal personnel and external service providers, and comparing this information to payments made, invoices received,
+Added: and the agreed-upon contractual fee to be paid for such services in the applicable contract or statements of work.
+Added: addition, the Company allocates certain internal compensation costs to research and development expenses based on management’s
+Added: estimates of each employee’s time and effort expended.
+Added: the Critical Matter was Addressed in the Audit:
+Added: primary procedures we performed to address this critical audit matter included the following:
+Added: obtained an understanding, and evaluated the design and implementation, of controls relating
+Added: to research and development costs, including controls over the review of third-party contracts,
+Added: the process of gathering information from external and internal sources and management’s
+Added: review thereof, and the determination of prepaid positions, period-end accruals, and expense
+Added: the Company’s significant third-party contracts, we performed the following procedures:
+Added: obtained and read related master service agreements, statements of work, or other supporting
+Added: agreements with the research institution, CRO, or CMO.
+Added: performed corroborating inquiries with management personnel responsible for the oversight
+Added: of the activities regarding the nature and status of work performed.
+Added: evaluated evidence of services provided by third parties including invoices regarding activities
+Added: completed, and we inspected evidence supporting payments made by the Company.
+Added: compared the data and evidence obtained from internal and external sources to the amounts
+Added: recorded by management and recalculated the related research and development expense and
+Added: prepaid research and development expense.
+Added: the Company’s internal compensation allocations, we performed the following procedures:
+Added: performed corroborating inquiries with management personnel responsible for the oversight
+Added: of the activities regarding the nature of employee services performed.
+Added: evaluated the reasonableness of allocations estimated by management by comparisons with prior
+Added: periods and evaluating the reasonableness of significant changes made by management.
+Added: obtained written representations from management regarding the appropriateness of allocation
have served as the Company’s auditor since 2013
4 unchanged sentences
Current assets:
−Removed: Cash and cash equivalents
+Added: Cash and cash
Short–term investments
−Removed: Prepaid expenses and other current assets
+Added: expenses and other current assets
Total current assets
−Removed: Operating lease right-of-use asset
−Removed: LIABILITIES AND EQUITY
+Added: Operating lease right-of-use
+Added: LIABILITIES AND
Current liabilities:
1 unchanged sentence
Accrued expenses
−Removed: Operating lease liability
+Added: lease liability
Total current liabilities
−Removed: Operating lease liability, non-current
−Removed: Total liabilities
+Added: Operating lease liability,
Commitments and contingencies (Note 6)
Shareholders’ equity:
−Removed: Preferred stock, par value $ 100 per share;
−Removed: 19,860 shares authorized;
+Added: Preferred stock, par value
+Added: 19,860 shares
issued or outstanding
−Removed: Series A convertible preferred stock, par value $ 100 per share;
−Removed: 140 shares authorized;
−Removed: no shares issued or outstanding
−Removed: Preferred stock
−Removed: Common stock, par value $ .01 per share;
+Added: Series A convertible preferred
+Added: stock, par value $ 100
shares authorized;
+Added: shares issued or outstanding
+Added: Preferred stock, value
+Added: Common stock, par value
+Added: 100,000,000 shares
31,145,219 and
−Removed: shares issued and outstanding as of October 31, 2022 and 2021, respectively
+Added: 30,913,902 shares
+Added: issued and outstanding as of October 31, 2023 and 2022, respectively
Additional paid-in capital
−Removed: Accumulated deficit
−Removed: Total shareholders’ equity
−Removed: Noncontrolling interest (Note 2)
−Removed: Total liabilities and equity
+Added: Total shareholders’
+Added: Noncontrolling
+Added: interest (Note 2)
+Added: liabilities and equity
accompanying notes are an integral part of these statements.
3 unchanged sentences
thousands, except per share data)
−Removed: For the years ended October 31,
+Added: the years ended October 31,
Operating costs and expenses:
−Removed: Inventor royalties, contingent legal fees, litigation and licensing expenses
−Removed: Research and development expenses (including non-cash share based compensation expenses of $ 3,635 and $ 4,166 , respectively)
−Removed: General and administrative expenses (including non-cash share based compensation expenses of $ 3,020 and $ 3,892 , respectively)
−Removed: Total operating costs and expenses
+Added: Inventor royalties, contingent
+Added: legal fees, litigation and licensing expenses
+Added: Research and development
+Added: expenses (including non-cash share based compensation expenses of $ 2,037
+Added: and $ 3,635 ,
+Added: respectively)
+Added: and administrative expenses (including non-cash share based compensation expenses of $ 2,698
+Added: and $ 3,117 ,
+Added: respectively)
+Added: Total operating costs
Loss from operations
−Removed: Gain on disposal of property and equipment
Interest income
−Removed: Net loss attributable to noncontrolling interest
−Removed: Net loss attributable to common stockholders
+Added: Net loss attributable
+Added: to noncontrolling interest
+Added: Net loss attributable
+Added: to common stockholders
Net loss per share:
−Removed: Basic and diluted
Weighted average common shares outstanding:
−Removed: Basic and diluted
accompanying notes are an integral part of these statements.
5 unchanged sentences
Shareholders’
−Removed: BALANCE, October 31, 2020
−Removed: $ ( 191,836 )
−Removed: Stock option compensation to employees and directors
−Removed: Expired restricted stock award to employee
+Added: October 31, 2021
$ ( 204,790 )
−Removed: Stock options and warrants issued to consultants
−Removed: Common stock issued upon exercise of stock options
−Removed: Common stock issued pursuant to employee stock purchase plan
−Removed: Common stock issued in a public offering, net of offering expenses of $ 2,208
−Removed: Common stock issued in an at-the-market offering, net of offering expenses of $ 341
−Removed: Proceeds received on sale of common stock held by ZQX Advisors, LLC
−Removed: BALANCE, October 31, 2021
+Added: option compensation to employees and directors
+Added: options and warrants issued to consultants
+Added: stock issued upon exercise of stock options and warrants
+Added: stock issued to consultants
+Added: stock issued pursuant to employee stock purchase plan
+Added: October 31, 2022
$ ( 218,385 )
−Removed: Balance, value
$ ( 218,385 )
−Removed: Stock option compensation to employees and directors
−Removed: Stock options and warrants issued to consultants
−Removed: Common stock issued upon exercise of stock options and warrants
−Removed: Common stock issued to consultants
−Removed: Common stock issued pursuant to employee stock purchase plan
−Removed: BALANCE, October 31, 2022
+Added: option compensation to employees and directors
+Added: options issued to consultants
+Added: stock issued upon exercise of stock options
+Added: stock issued to consultants
+Added: stock issued pursuant to employee stock purchase plan
+Added: October 31, 2023
$ ( 228,196 )
−Removed: Balance, value
$ ( 228,196 )
−Removed: Shareholders’ Equity [Member]
accompanying notes are an integral part of these statements.
2 unchanged sentences
STATEMENTS OF CASH FLOWS
−Removed: For the years ended October 31,
+Added: the years ended October 31,
Cash flows from operating activities:
−Removed: Reconciliation of net loss to net cash used in operating activities:
−Removed: Stock option compensation to employees and directors
−Removed: Stock options and warrants issued to consultants
−Removed: Common stock issued to consultants
−Removed: Gain on disposal of property and equipment
−Removed: Amortization of operating lease right-of-use asset
−Removed: Change in operating assets and liabilities:
−Removed: Prepaid expenses and other current assets
+Added: Reconciliation of net loss to net cash used
+Added: in operating activities:
+Added: Stock option compensation
+Added: to employees and directors
+Added: Stock options and warrants
+Added: issued to consultants
+Added: Common stock issued to
+Added: Amortization of operating
+Added: lease right-of-use asset
+Added: Change in operating assets
+Added: and liabilities:
+Added: Prepaid expenses and other
+Added: current assets
Accounts payable
Accrued expenses
−Removed: Operating lease liability
−Removed: Net cash used in operating activities
+Added: lease liability
+Added: cash used in operating activities
Cash flows from investing activities:
−Removed: Disbursements to acquire short-term investments
−Removed: Proceeds from maturities of short-term investments
−Removed: Proceeds from sale of equipment
−Removed: Proceeds received on sale of common stock by ZQX Advisors, LLC
−Removed: Net cash used in investing activities
+Added: Disbursements to acquire
+Added: short-term investments
+Added: from maturities of short-term investments
+Added: cash used in investing activities
Cash flows from financing activities:
−Removed: Proceeds from sale of common stock in a public offering, net of expenses
−Removed: Proceeds from sale of common stock in an at-the-market offering, net of expenses
−Removed: Proceeds from sale of common stock pursuant to employee stock purchase plan
−Removed: Proceeds from exercise of stock options and warrants
−Removed: Net cash provided by financing activities
−Removed: Net (decrease) increase in cash and cash equivalents
−Removed: Cash and cash equivalents at beginning of year
−Removed: Cash and cash equivalents at end of year
+Added: Proceeds from sale of common
+Added: stock pursuant to employee stock purchase plan
+Added: from exercise of stock options and warrants
+Added: cash provided by financing activities
+Added: Net decrease in cash and cash equivalents
+Added: Cash and cash equivalents
+Added: at beginning of year
+Added: Cash and cash equivalents
+Added: at end of year
Supplemental cash flow information:
−Removed: Cash proceeds from interest income
−Removed: Supplemental disclosure of non-cash investing activity:
−Removed: Operating lease right-of-use asset
−Removed: Supplemental disclosure of non-cash financing activities:
−Removed: Operating lease liability
−Removed: Fair value of warrants issued in connection with public offering
+Added: proceeds from interest income
accompanying notes are an integral part of these statements.
5 unchanged sentences
and its consolidated subsidiaries.
−Removed: is a biotechnology company developing therapies and vaccines that are focused on critical unmet needs in oncology and infectious disease.
+Added: Biosciences, Inc.
+Added: is a biotechnology company developing vaccines and therapies that are focused on critical unmet needs in oncology.
Our vaccine programs include (i) the development of a preventative vaccine against triple negative breast cancer (“TNBC”),
4 unchanged sentences
at our subsidiary, Certainty Therapeutics, Inc.
−Removed: (“Certainty”), and (ii) the development of anti-viral drug candidates for
−Removed: the treatment of COVID-19 focused on inhibiting certain protein functions of the virus.
+Added: (“Certainty”), and (ii) until March 2023, the development of anti-viral drug
+Added: candidates for the treatment of COVID-19 focused on inhibiting certain protein functions of the virus.
hold an exclusive worldwide, royalty-bearing license to use certain intellectual property owned or controlled by The Cleveland Clinic
Foundation (“Cleveland Clinic”) relating to certain breast cancer vaccine technology developed at Cleveland Clinic.
+Added: agreement requires us to make certain cash payments to Cleveland Clinic upon achievement of specific development milestones.
this technology, we are working in collaboration with Cleveland Clinic to develop a method to vaccinate women against contracting breast
−Removed: cancer, focused specifically on TNBC.
+Added: cancer, focused initially on TNBC.
The focus of this vaccine is a specific protein, α-lactalbumin, that is only expressed during
3 unchanged sentences
Studies have shown that vaccinating against this protein prevents breast cancer in mice.
−Removed: Food and Drug Administration’s (“FDA”) authorization to proceed with clinical trials in December 2020, in
−Removed: October 2021, we commenced dosing patients in a Phase 1 clinical trial of our breast cancer vaccine.
−Removed: This study, which is being funded
−Removed: Department of Defense grant, is a multiple-ascending dose Phase 1 trial to determine the maximum tolerated dose (“MTD”)
−Removed: of the vaccine in patients with early-stage, triple-negative breast cancer as well as monitor immune response.
+Added: October 2021, following the U.S.
+Added: Food and Drug Administration’s (“FDA”) authorization to proceed, we commenced dosing
+Added: patients in a Phase 1 clinical trial of our breast cancer vaccine.
+Added: This study, which is being funded by a U.S.
+Added: Department of Defense
+Added: grant to Cleveland Clinic, is a multiple-ascending dose Phase 1 trial to determine the maximum tolerated dose (“MTD”) of
+Added: the vaccine in patients with early-stage, triple-negative breast cancer as well as monitor immune response.
The study is being conducted
−Removed: at Cleveland Clinic and will consist of 18 to 24 patients who have completed treatment for early-stage, triple-negative breast cancer
−Removed: within the past three years and are currently tumor-free but at high risk for recurrence.
−Removed: During the course of the study, participants
−Removed: will receive three vaccinations, each two weeks apart, and will be closely monitored for side effects and immune response.
−Removed: Initial indications
−Removed: from preliminary analyses suggest that an immune response is being observed.
−Removed: In December 2022, we announced that we had reached the MTD.
−Removed: We are now expanding the MTD cohort and are vaccinating additional participants at that dose level.
−Removed: Upon completion of vaccination and
−Removed: follow-up tests of the expanded cohort, we will compile and analyze the data, and we anticipate presenting the complete immunological
−Removed: data from the trial at a scientific conference or similar setting in the second calendar quarter of 2023.
−Removed: November 2020, we executed a license agreement with Cleveland Clinic pursuant to which the Company was granted an exclusive worldwide,
−Removed: royalty-bearing license to use certain intellectual property owned or controlled by Cleveland Clinic relating to certain ovarian cancer
−Removed: vaccine technology.
−Removed: This technology pertains to among other things, the use of vaccines for the treatment or prevention of ovarian cancers
−Removed: which express the anti-Mullerian hormone receptor 2 protein containing an extracellular domain (“AMHR2-ED”).
−Removed: In healthy tissue,
−Removed: this protein regulates growth and development of egg-containing follicles in the ovary.
−Removed: While expression of AMHR2-ED naturally and markedly
−Removed: declines after menopause, this protein is expressed at high levels in the ovaries of postmenopausal women with ovarian cancer.
−Removed: at Cleveland Clinic believe that a vaccine targeting AMHR2-ED could prevent the occurrence of ovarian cancer.
−Removed: We entered into a joint
−Removed: development agreement with Cleveland Clinic to advance this vaccine toward human clinical testing.
+Added: at Cleveland Clinic.
+Added: The first segment of the study, Phase 1a, will consist of 18 to 24 patients who have completed treatment for early-stage,
+Added: triple-negative breast cancer within the past three years and are currently tumor-free but at high risk for recurrence.
+Added: 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
+Added: after standard of care treatment.
+Added: During the course of the Phase 1a study, participants will receive three vaccinations, each two weeks
+Added: apart, and will be closely monitored for side effects and immune response.
+Added: In January 2023, the number of participants in each dose cohort
+Added: was expanded, and as of August 2023, we had completed vaccinating all patients in these expanded cohorts.
+Added: In December 2023, we presented
+Added: the immunological data collected to date at the San Antonio Breast Cancer Symposium.
+Added: The data presented show that in the vaccinated women
+Added: who had been tested to date, various levels of antigen-specific T cell responses were observed at all dose levels.
+Added: We have begun vaccinating
+Added: participants in up to three additional dose cohorts at dose levels higher than the currently determined MTD and lower than the highest
+Added: dose where we observed dose limiting toxicity.
+Added: Further, we have commenced vaccination of participants in the second segment of the trial,
+Added: Phase 1b, that includes participants who have never had cancer, but carry certain genetic mutations such as BRCA1, BRCA2 or PALB2, that
+Added: indicate a greater risk of developing TNBC in the future, and have elected to have a prophylactic mastectomy.
+Added: Finally, we are currently
+Added: enrolling participants in the third segment of the trial, Phase 1c, that includes post-operative TNBC patients that have residual disease
+Added: following neoadjuvant chemo-immunotherapy and are currently undergoing treatment with pembrolizumab (Keytruda®).
BIOSCIENCES, INC.
1 unchanged sentence
TO CONSOLIDATED FINANCIAL STATEMENTS
−Removed: May 2021, Cleveland Clinic was granted an award for our ovarian cancer vaccine technology by the National Cancer Institute’s (“NCI”)
−Removed: PREVENT program.
−Removed: The NCI is a part of the National Institutes of Health.
−Removed: The PREVENT program is a peer-reviewed agent development program
−Removed: designed to support pre-clinical development of innovative interventions and biomarkers for cancer prevention and interception towards
−Removed: clinical trials.
−Removed: The scientific and financial resources of the PREVENT program will be used for our ovarian cancer vaccine technology
−Removed: to perform virtually all pre-clinical research and development, manufacturing and IND-enabling studies.
−Removed: This work is being performed
−Removed: at NCI facilities, by NCI scientific staff and with NCI financial resources and will require no material financial expenditures by the
−Removed: Company, nor the transfer of any rights to the Company’s assets.
+Added: November 2020, we executed a license agreement with Cleveland Clinic pursuant to which the Company was granted an exclusive worldwide,
+Added: royalty-bearing license to use certain intellectual property owned or controlled by Cleveland Clinic relating to certain ovarian cancer
+Added: vaccine technology.
+Added: The license agreement requires us to make certain cash payments to Cleveland Clinic upon achievement of specific
+Added: development milestones.
+Added: This technology pertains to among other things, the use of vaccines for the treatment or prevention of ovarian
+Added: cancers which express the anti-Mullerian hormone receptor 2 protein containing an extracellular domain (“AMHR2-ED”).
+Added: tissue, this protein regulates growth and development of egg-containing follicles in the ovary.
+Added: While expression of AMHR2-ED naturally
+Added: and markedly declines during menopause, this protein is expressed at high levels in the ovaries of postmenopausal women with ovarian
+Added: Researchers at Cleveland Clinic believe that a vaccine targeting AMHR2-ED could prevent the occurrence of ovarian cancer.
+Added: May 2021, Cleveland Clinic was granted acceptance for our ovarian cancer vaccine technology into the National Cancer Institute’s
+Added: (“NCI”) PREVENT program.
+Added: The NCI is a part of the National Institutes of Health (“NIH”).
+Added: The PREVENT program
+Added: is a peer-reviewed agent development program designed to support pre-clinical development of innovative interventions and biomarkers
+Added: for cancer prevention and interception towards clinical trials.
+Added: The scientific and financial resources of the PREVENT program are being
+Added: used for our ovarian cancer vaccine technology to perform virtually all pre-clinical research and development, manufacturing and Investigational
+Added: New Drug (“IND”) application enabling studies.
+Added: This work is being performed at NCI facilities, by NCI scientific staff and
+Added: with NCI financial resources and will require no material financial expenditures by the Company, nor the transfer of any rights of the
+Added: Company’s assets.
subsidiary, Certainty, is developing immuno-therapy drugs against cancer.
1 unchanged sentence
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 National Cancer Institute designated cancer research center, relating to Wistar’s chimeric
−Removed: endocrine receptor targeted therapy technology.
−Removed: We have initially focused on the development of a treatment for ovarian cancer, but we
−Removed: also may pursue applications of the technology for the development of treatments for additional solid tumors.
−Removed: The license agreement requires
−Removed: Certainty to make certain cash and equity payments to Wistar upon achievement of specific development milestones.
−Removed: With respect to Certainty’s
−Removed: equity obligations to Wistar, Certainty issued to Wistar shares of its common stock equal to five percent ( 5 %) of the common stock of
+Added: biomedical research institute and a leading NCI designated cancer research center, relating to Wistar’s chimeric endocrine receptor
+Added: targeted therapy technology.
+Added: We have initially focused on the development of a treatment for ovarian cancer, but we also may pursue applications
+Added: of the technology for the development of treatments for additional solid tumors.
+Added: The license agreement requires Certainty to make certain
+Added: cash 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 %)
+Added: of the common stock of Certainty, such equity stake subject to dilution by further funding of Certainty’s activities by the Company.
+Added: Due to such Company funding, Wistar’s equity stake in Certainty was 4.6% as of October 31, 2023.
in collaboration with the H.
Lee Moffitt Cancer Center and Research Institute, Inc.
−Removed: (“Moffitt”), is advancing toward human
−Removed: clinical testing of the CAR-T technology licensed by Certainty from Wistar aimed initially at treating ovarian cancer.
−Removed: We received authorization
−Removed: from the FDA in August 2021, to commence enrollment and treatment of patients in a Phase 1 clinical trial.
−Removed: We began patient recruitment
−Removed: for the trial in March 2022, and in August 2022, we treated the first patient in the trial.
−Removed: The treatment appears to have been well-tolerated
−Removed: by the patient, and we continue to monitor her condition.
−Removed: The process of recruiting additional patients is ongoing.
−Removed: This study is a dose-escalation
−Removed: trial with two arms based on injection method—intraperitoneal or intravenous—to determine the maximum tolerated dose in patients
−Removed: with recurrent epithelial ovarian cancer and to assess persistence, expansion and efficacy of the modified T-cells.
−Removed: The study is being
−Removed: conducted at Moffitt and will consist of 24 to 48 patients who have received at least two prior lines of chemotherapy.
−Removed: The study is estimated
−Removed: to be completed in two to four years depending on multiple factors including when maximum tolerated dose is reached, the rate of patient
−Removed: recruitment, and how long we maintain the two different injection methods.
−Removed: April 2020, we entered into a collaboration with OntoChem GmbH (“OntoChem”) to discover and ultimately develop anti-viral
−Removed: drug candidates against COVID-19.
−Removed: Through this collaboration, we utilized advanced computational methods, machine learning, and molecular
−Removed: modeling techniques to perform in silico screening of over 1.2 billion compounds in chemical libraries (including publicly available
−Removed: compounds and OntoChem’s proprietary libraries) to evaluate if any of these compounds could disrupt one of two key enzymes of SARS-CoV-2,
−Removed: the virus that causes the disease COVID-19.
+Added: (“Moffitt”), has begun human clinical
+Added: testing of the CAR-T technology licensed by Certainty from Wistar aimed initially at treating ovarian cancer.
+Added: After receiving authorization
+Added: from the FDA, we commenced enrollment of patients in a Phase 1 clinical trial and treated the first patient in August 2022.
+Added: 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
+Added: patient, and the treatment appears to have been well-tolerated by all patients treated to date.
+Added: We anticipate that we will begin enrolling
+Added: the successive patient cohort, that we expect to give a three-times higher dose of cells, in the first calendar quarter of 2024.
+Added: study is a dose-escalation trial with two arms based on delivery method—intraperitoneal or intravenous—to determine the maximum
+Added: tolerated dose in patients with recurrent epithelial ovarian cancer and to assess persistence, expansion and efficacy of the modified
+Added: The study is being conducted at Moffitt and will consist of 24 to 48 patients who have received at least two prior lines of
+Added: chemotherapy.
+Added: The study is estimated to be completed in two to four years depending on multiple factors including when maximum tolerated
+Added: dose is reached, the rate of patient enrollment, and how long we maintain the two different delivery methods.
BIOSCIENCES, INC.
1 unchanged sentence
TO CONSOLIDATED FINANCIAL STATEMENTS
−Removed: screening process resulted in the identification of multiple compounds that could potentially disrupt critical enzymes of the virus,
−Removed: including the virus’ main protease, M pro .
−Removed: Several of these compounds were synthesized and tested in in vitro
−Removed: biological assays.
−Removed: Upon completion of these biological assays, we identified two of the most promising compounds and tested them in animal
−Removed: In these animal studies, the two compounds were compared to Remdesivir, which at the time the assays were performed was the only
−Removed: anti-viral drug authorized by the FDA for COVID-19.
−Removed: The data showed that administration of the drugs to infected hamsters did not cause
−Removed: any noticeable adverse effects, and monitoring of weight and general animal behavior demonstrated comparable efficacy between each of
−Removed: our compounds and Remdesivir.
−Removed: Based on this promising data in the animal study, we directed our team to proceed to the next stage of
−Removed: drug development and we selected one of the compounds around which our team is performing combinatorial synthetic medicinal chemistry
−Removed: to evaluate whether potency can be increased and pharmacokinetics optimized.
−Removed: This work is ongoing.
−Removed: May 2021, after completion of the aforementioned animal studies, OntoChem assigned its rights and obligations related to this collaboration
−Removed: to MolGenie GmbH (“MolGenie”), a company spun-out from OntoChem focused on drug discovery and development.
−Removed: As a result of
−Removed: the MolGenie spin-out, there was no change in the personnel working on our project, and the assignment caused no interruptions to the
−Removed: program’s development.
−Removed: use of preventative vaccines is widespread throughout much of the developed world, we believe that there is and will continue to be a
−Removed: need for effective treatments for COVID-19.
−Removed: We believe that there are a number of factors that have limited the effectiveness, both in
−Removed: the near and long term, of the vaccines currently in use, including, but not limited to, vaccine persistence, viral escape and perceptions
−Removed: of long-term safety resulting in vaccine resistance.
−Removed: Furthermore, there are currently new anti-viral treatments, such as Pfizer’s
−Removed: Paxlovid, which is a combination therapy consisting of the protease-inhibitor nirmatrelvir and the antiretroviral ritonavir, that have
−Removed: been authorized for use in the U.S.
−Removed: As the main component of Pfizer’s treatment is a protease-inhibitor targeting M pro ,
−Removed: it is most similar to our compounds, and we therefore conducted a head-to-head analysis via a Fluorescence Resonance Energy Transfer
−Removed: (FRET) assay that tested the ability of the compounds to inhibit the function of M pro .
−Removed: The results of this head-to-head in
−Removed: vitro analysis suggest that our compounds may be five times more effective at inhibiting M pro than Pfizer’s nirmatrelvir.
−Removed: the next several quarters, we expect the development of our breast and ovarian cancer vaccines, our COVID-19 therapeutic discovery program
−Removed: and Certainty’s CAR-T technology to be the primary focus of the Company.
−Removed: As part of our legacy operations, the Company remains
−Removed: engaged in limited patent licensing activities regarding its liquid biopsy platform and in the area of encrypted audio/video conference
−Removed: We do not expect these activities to be a significant part of the Company’s ongoing operations nor do we expect these
−Removed: activities to require material financial resources or attention of senior management.
+Added: April 2020, we entered into a collaboration with OntoChem GmbH (“OntoChem”) which was later assigned to MolGenie GmbH, a
+Added: company spun-out from OntoChem focused on drug discovery and development, to discover and ultimately develop anti-viral drug candidates
+Added: against COVID-19.
+Added: Through this collaboration, we identified compounds that appeared to be effective in disrupting the main protease of
+Added: SARS-CoV-2, the virus that causes the disease COVID-19.
+Added: While our compounds have shown promise as an effective treatment, results of
+Added: animal studies indicate that there is not sufficient oral bioavailability, and it is unclear whether an orally delivered treatment may
+Added: be developed.
+Added: We do not currently believe that there is a viable market for an injectable treatment given the current oral treatments
+Added: Furthermore, we believe the needed additional investment in research for alternative delivery methods would divert resources
+Added: from more promising projects.
+Added: Therefore, in March 2023, we decided to pause further development of our COVID-19 therapeutic.
+Added: to prosecute our U.S.
+Added: patent applications of this technology and may decide to restart development at some time in the future.
+Added: the next several quarters, we expect the development of our vaccines and therapeutics to be the primary focus of the Company.
+Added: of our legacy operations, the Company remains engaged in limited patent licensing activities of its various patent portfolios.
+Added: not expect these activities to be a significant part of the Company’s ongoing operations nor do we expect these activities to require
+Added: material financial resources or attention of senior management.
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.
−Removed: We have not generated any revenue to date from our therapeutics or vaccine programs.
−Removed: In addition, while
−Removed: we pursue our therapeutics and vaccine programs, we may also make investments in and form new companies to develop additional emerging
−Removed: technologies.
−Removed: We do not expect to begin generating revenue with respect to any of our current therapy or vaccine programs in the near
−Removed: Our strategy is to achieve a profitable outcome by eventually licensing our technologies to large pharmaceutical companies that
−Removed: have the resources and infrastructure in place to manufacture, market and sell our technologies as therapeutics or vaccines.
−Removed: licensing of any of our technologies may take several years, if it is to occur at all, and may depend on positive results from human
−Removed: clinical trials.
−Removed: BIOSCIENCES, INC.
−Removed: AND SUBSIDIARIES
−Removed: TO CONSOLIDATED FINANCIAL STATEMENTS
+Added: the settlement of litigation (during the year ended October 31, 2023, we derived approximately $ 210,000
+Added: of revenue from these activities).
+Added: generated any revenue to date from our vaccine or therapeutics programs.
+Added: In addition, while we pursue our vaccine and therapeutics programs,
+Added: we may also make investments in and form new companies to develop additional emerging technologies.
+Added: We do not expect to begin generating
+Added: revenue with respect to any of our current vaccine or therapy programs in the near term.
+Added: We hope to achieve a profitable outcome by eventually
+Added: licensing our technologies to large pharmaceutical companies that have the resources and infrastructure in place to manufacture, market
+Added: and sell our technologies as vaccines or therapeutics.
+Added: The eventual licensing of any of our technologies may take several years, if it
+Added: is to occur at all, and may depend on positive results from human clinical trials.
and Management’s Plans
10 unchanged sentences
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, 2022, we may sell up to $ 100 million of common stock.
−Removed: We did not sell any shares under our at-the-market
−Removed: equity program during the year ended October 31, 2022.
−Removed: We may seek to obtain working capital during our fiscal year 2023 or thereafter
−Removed: through sales of our equity securities or through bank credit facilities or public or private debt from various financial institutions
−Removed: where possible.
−Removed: We cannot be certain that additional funding will be available on acceptable terms, or at all.
−Removed: If we do identify sources
−Removed: for additional funding, the sale of additional equity securities or convertible debt will result in dilution to our stockholders.
−Removed: can give no assurance that we will generate sufficient cash flows in the future to satisfy our liquidity requirements or sustain future
−Removed: operations, or that other sources of funding, such as sales of equity or debt, would be available or would be approved by our security
−Removed: holders, if needed, on favorable terms or at all.
−Removed: If we fail to obtain additional working capital as and when needed, such failure could
−Removed: have a material adverse impact on our business, results of operations and financial condition.
−Removed: Furthermore, such lack of funds may inhibit
−Removed: our ability to respond to competitive pressures or unanticipated capital needs, or may force us to reduce operating expenses, which would
−Removed: significantly harm the business and development of operations.
+Added: use in the future, as of October 31, 2023, we may sell up to $ 100
+Added: million of common stock.
+Added: We did not sell any
+Added: shares under our at-the-market equity program during the fiscal year ended October 31, 2023.
+Added: We may seek to obtain working capital during
+Added: our fiscal year 2024 or thereafter through sales of our equity securities or through bank credit facilities or public or private debt
+Added: from various financial institutions where possible.
+Added: We cannot be certain that additional funding will be available on acceptable terms,
+Added: If we do identify sources for additional funding, the sale of additional equity securities or convertible debt will result
+Added: in dilution to our stockholders.
+Added: We can give no assurance that we will generate sufficient cash flows in the future to satisfy our liquidity
+Added: requirements or sustain future operations, or that other sources of funding, such as sales of equity or debt, would be available or would
+Added: be approved by our security holders, if needed, on favorable terms or at all.
+Added: If we fail to obtain additional working capital as and
+Added: when needed, such failure could have a material adverse impact on our business, results of operations and financial condition.
+Added: such lack of funds may inhibit our ability to respond to competitive pressures or unanticipated capital needs, or may force us to reduce
+Added: operating expenses, which would significantly harm the business and development of operations.
+Added: BIOSCIENCES, INC.
+Added: AND SUBSIDIARIES
+Added: TO CONSOLIDATED FINANCIAL STATEMENTS
SUMMARY OF SIGNIFICANT ACCOUNTING POLICIES
6 unchanged sentences
interest represents Wistar’s equity ownership in Certainty and is presented as a component of equity.
−Removed: The following table
−Removed: sets forth the changes in noncontrolling interest for the two years ended October 31, 2022 (in thousands):
+Added: The following table sets
+Added: forth the changes in noncontrolling interest for the two years ended October 31, 2023 (in thousands):
OF CHANGES IN NONCONTROLLING INTEREST
Balance October 31, 2021
−Removed: Net loss attributable to noncontrolling interest
+Added: Net loss attributable
+Added: to noncontrolling interest
Balance October 31, 2022
−Removed: Net loss attributable to noncontrolling interest
+Added: Net loss attributable
+Added: to noncontrolling interest
Balance October 31,
8 unchanged sentences
is distinct from other promised goods or services and evaluating whether a license transfers to a customer at a point in time or over
+Added: revenue arrangements provide for the payment, within 30 days of execution of the agreement, of contractually determined, one-time, paid-up
+Added: license fees in settlement of litigation and in consideration for the grant of certain intellectual property rights for patented technologies
+Added: owned or controlled by the Company.
+Added: These arrangements typically include some combination of the following:
+Added: (i) the grant of a non-exclusive,
+Added: retroactive and future license to manufacture and/or sell products covered by patented technologies owned or controlled by the Company,
+Added: (ii) a covenant-not-to-sue, (iii) the release of the licensee from certain claims, and (iv) the dismissal of any pending litigation.
+Added: In 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
+Added: rights, including no obligation to maintain or upgrade the technology, or provide future support or services.
+Added: Licensees obtained control
+Added: of the intellectual property rights they have acquired upon execution of the agreement.
+Added: Accordingly, the performance obligations from
+Added: these agreements were satisfied and 100 %
+Added: of the revenue was recognized upon the execution of the agreements.
BIOSCIENCES, INC.
1 unchanged sentence
TO CONSOLIDATED FINANCIAL STATEMENTS
−Removed: revenue arrangements generally provide for the payment, within 30 days of execution of the agreement, of contractually determined, one-time,
−Removed: paid-up license fees in settlement of litigation and in consideration for the grant of certain intellectual property rights for patented
−Removed: technologies owned or controlled by the Company.
−Removed: These arrangements typically include some combination of the following:
−Removed: (i) the grant
−Removed: of a non-exclusive, retroactive and future license to manufacture and/or sell products covered by patented technologies owned or controlled
−Removed: by the Company, (ii) a covenant-not-to-sue, (iii) the release of the licensee from certain claims, and (iv) the dismissal of any pending
−Removed: In such instances, the intellectual property rights granted have been perpetual in nature, extending until the expiration
−Removed: of the related patents.
−Removed: Pursuant to the terms of these agreements, we have no further obligations with respect to the granted intellectual
−Removed: property rights, including no obligation to maintain or upgrade the technology, or provide future support or services.
−Removed: Licensees obtained
−Removed: control of the intellectual property rights they have acquired upon execution of the agreement.
−Removed: Accordingly, the performance obligations
−Removed: from these agreements were satisfied and 100 % of the revenue was recognized upon the execution of the agreements.
of revenues include the costs and expenses incurred in connection with our patent licensing and enforcement activities, including inventor
4 unchanged sentences
and Development Expenses
−Removed: and development expenses, consisting primarily of employee compensation, payments to third parties for research and development activities,
−Removed: including expenses related to clinical trials, and other direct costs associated with developing immuno-therapy drugs against cancer,
−Removed: developing anti-viral drug candidates for COVID-19, developing our breast cancer vaccine and developing our ovarian cancer vaccine, are
−Removed: expensed in the consolidated financial statements in the year incurred.
+Added: and development expenses consist primarily of payments to third parties for research and development activities, including expenses related
+Added: to clinical trials, employee compensation, and other direct costs associated with developing our therapeutics and vaccines.
+Added: recognize research and development expenses as incurred.
+Added: Advance payments for future research and development activities are deferred
+Added: and expensed as the services are performed.
+Added: We recognize our preclinical studies and clinical trial expenses based on the services performed
+Added: pursuant to contracts with research institutions, clinical research organizations (“CROs”), clinical manufacturing organizations
+Added: (“CMOs”), and other parties that conduct and manage various stages of research and development activities on our behalf.
+Added: Fees for such services are recognized based on management’s estimates after considering the activities and tasks completed by each
+Added: service provider in a given period, the time period over which services are expected to be performed, and the level of effort expended
+Added: in each reporting period.
+Added: each balance sheet date, management estimates prepaid and accrued research and development costs by discussing progress or stage of completion
+Added: of activities with internal personnel and external service providers, and comparing this information to payments made, invoices received,
+Added: and the agreed-upon contractual fee to be paid for such services in the applicable contract or statements of work.
+Added: In addition, we allocate certain internal compensation
+Added: costs to research and development expenses based on management’s estimates of each employee’s time and effort expended.
Value Measurements
12 unchanged sentences
which we have the ability to access at the measurement date.
−Removed: BIOSCIENCES, INC.
−Removed: AND SUBSIDIARIES
−Removed: TO CONSOLIDATED FINANCIAL STATEMENTS
2 – Financial instruments whose values are based on quoted market prices in markets where trading occurs infrequently or whose
4 unchanged sentences
a market participant would use in pricing the instrument.
+Added: BIOSCIENCES, INC.
+Added: AND SUBSIDIARIES
+Added: TO CONSOLIDATED FINANCIAL STATEMENTS
following table presents the hierarchy for our financial assets measured at fair value on a recurring basis as of October 31, 2023 (in
−Removed: OF HIERARCHY OF FINANCIAL ASSETS
−Removed: market funds:
−Removed: term investments
+Added: OF FAIR VALUE MEASUREMENTS
+Added: Money market funds:
+Added: Cash equivalents
+Added: Certificates of deposit:
+Added: Short term investments
treasury bills:
term investments
−Removed: financial assets
+Added: Total financial assets
following table presents the hierarchy for our financial assets measured at fair value on a recurring basis as of October 31, 2022 (in
−Removed: market funds:
−Removed: term investments
+Added: Money market funds:
+Added: Cash equivalents
+Added: Certificates of deposit:
+Added: Cash equivalents
+Added: Short term investments
treasury bills:
term investments
−Removed: financial assets
+Added: Total financial assets
non-financial assets that are measured on a non-recurring basis are property and equipment and other assets which are measured using
4 unchanged sentences
Cash equivalents are stated at carrying value which approximates fair value.
−Removed: equivalents consists of highly liquid, short-term investments with original maturities of three months or less when purchased.
−Removed: BIOSCIENCES, INC.
−Removed: AND SUBSIDIARIES
−Removed: TO CONSOLIDATED FINANCIAL STATEMENTS
+Added: equivalents consist of highly liquid, short-term investments with original maturities of three months or less when purchased.
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 $ 17,327 and $ 6,599 , respectively, that were classified as short-term investments and reported at fair
+Added: than 12 months when acquired of approximately $ 22,929,000
+Added: and $ 17,327,000 ,
+Added: respectively, that were classified as short-term investments and reported at fair value.
recognize deferred tax assets and liabilities for the estimated future tax effects of events that have been recognized in our financial
4 unchanged sentences
A valuation allowance is established, when necessary, to reduce deferred tax assets to the amount expected to be
−Removed: maintain stock equity incentive plans under which we may grant non-qualified stock options, incentive stock options, stock appreciation
−Removed: rights, stock awards, performance awards and stock units to employees, non-employee directors and consultants.
+Added: BIOSCIENCES, INC.
+Added: AND SUBSIDIARIES
+Added: TO CONSOLIDATED FINANCIAL STATEMENTS
+Added: maintain equity incentive plans under which we may grant incentive stock options, non-qualified stock options, stock appreciation rights,
+Added: stock awards, performance awards, or stock units to employees, directors and consultants.
Option Compensation Expense
3 unchanged sentences
recorded stock-based compensation expense, related to service-based stock options granted to employees and directors, of approximately
−Removed: $ 3,463,000 and $ 3,531,000 , during the years ended October 31, 2022 and 2021, respectively.
−Removed: Included in stock-based compensation cost
−Removed: for service-based options granted to employees and directors during the years ended October 31, 2022 and 2021 was approximately $ 2,788,000
−Removed: and $ 1,841,000 , respectively, related to the amortization of compensation cost for stock options granted in prior periods but not yet
−Removed: As of October 31, 2022, there was unrecognized compensation cost related to non-vested service-based stock options granted to
−Removed: employees and directors of approximately $ 5,141,000 , which will be recognized over a weighted-average period of 1 year.
−Removed: stock options that vest based on market conditions, such as the trading price of the Company’s common stock exceeding certain
−Removed: price targets, we use a Monte Carlo Simulation in estimating the fair value at grant date and recognize compensation expense over
−Removed: the implied service period (median time to vest).
−Removed: On May 8, 2018, we issued market condition stock options to purchase 1,500,000
−Removed: shares of common stock, to our Chairman, then-President and Chief Executive Officer, vesting at target trading prices of $ 5.00
−Removed: per share before May
−Removed: 31, 2021 , with implied service periods of three
−Removed: The assumptions used in the Monte Carlo Simulation for the May 18, 2018 grant were stock price on date of grant and
+Added: and $ 3,463,000 ,
+Added: during the years ended October 31, 2023 and 2022, respectively.
+Added: Included in stock-based compensation cost for service-based options granted
+Added: to employees and directors during the years ended October 31, 2023 and 2022 was approximately $ 3,023,000
+Added: and $ 2,788,000 ,
+Added: respectively, related to the amortization of compensation cost for stock options granted in prior periods but not yet vested.
+Added: As of October
+Added: 31, 2023, there was unrecognized compensation cost related to non-vested service-based stock options granted to employees and directors
+Added: of approximately $ 5,194,000 ,
+Added: which will be recognized over a weighted-average period of 1.7
+Added: stock options that vest based on market conditions, such as the trading price of the Company’s common stock exceeding certain price
+Added: targets, we use a Monte Carlo Simulation in estimating the fair value at grant date and recognize compensation expense over the implied
+Added: service period (median time to vest).
+Added: On June 1, 2021, our Chairman, then-President and Chief Executive Officer and our Chief Operating
+Added: Officer and Chief Financial Officer were awarded market condition stock options for 2,000,000
+Added: shares and 100,000
+Added: shares of common stock, respectively, that vest
+Added: in four equal installments upon the Company’s share price achieving targets ranging from $ 5.00
+Added: per share, with implied service periods of three
+Added: to fifteen months.
+Added: The assumptions used in the Monte Carlo Simulation for the June 1, 2021 grants were stock price on date of grant and
exercise price of $ 4.02 ,
2 unchanged sentences
and risk-free interest rate of 1.62 %.
−Removed: In October 2018, the first tranche of 500,000
−Removed: shares of market condition options became exercisable upon achieving an average closing price above $ 5.00
−Removed: per share for twenty
−Removed: consecutive trading days.
−Removed: The remaining tranches did not vest as of May 31, 2021 and expired.
−Removed: BIOSCIENCES, INC.
−Removed: AND SUBSIDIARIES
−Removed: TO CONSOLIDATED FINANCIAL STATEMENTS
−Removed: June 1, 2021, our Chairman, then-President and Chief Executive Officer and our Chief Operating Officer and Chief Financial Officer were awarded
−Removed: market condition stock options for 2,000,000 shares and 100,000 shares of common stock, respectively, that vest in four equal installments
−Removed: upon the Company’s share price achieving targets ranging from $ 5.00 to $ 8.00 per share, with implied service periods of three to
−Removed: 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 , contract term of 10 years, expected volatility of 75 % and risk-free interest rate of 1.62 %.
As of October 31, 2023, 500,000
−Removed: 2022, 500,000 options and 25,000 options granted to our Chairman, then-President and Chief Executive Officer and our Chief Operating Officer
−Removed: and Chief Financial Officer, respectively, have vested.
−Removed: recorded stock-based compensation expense related to market condition stock options granted to employees of approximately $ 2,537,000
−Removed: during the year ended October 31, 2022, which amount represented expense related to the amortization of compensation cost for stock options
−Removed: granted during the year ended October 31, 2021.
+Added: options and 25,000
+Added: options granted to our Chairman, then-President
+Added: and Chief Executive Officer and our Chief Operating Officer and Chief Financial Officer, respectively, have vested.
+Added: the year ended October 31, 2023, we recorded no
+Added: stock-based compensation expense related to market
+Added: condition stock options granted to employees.
We recorded stock-based compensation expense related to market condition stock options
−Removed: granted to employees of approximately $ 3,972,000 during the year ended October 31, 2021, which amount did not include any expense related
−Removed: to the amortization of compensation cost for stock options granted in prior periods.
−Removed: As of October 31, 2022, there was no unrecognized
−Removed: compensation cost related to market condition stock options granted to employees.
+Added: granted to employees of approximately $ 2,537,000
+Added: during the year ended October 31, 2022, which
+Added: amount represented expense related to the amortization of compensation cost for stock options granted during the year ended October 31,
+Added: As of October 31, 2023, there was no
+Added: unrecognized compensation cost related to market
+Added: condition stock options granted to employees.
recorded consulting expense, related to service-based stock options granted to consultants, during the years ended October 31, 2023 and
−Removed: 2021 of approximately $ 434,000 and $ 460,000 , respectively.
−Removed: Included in stock-based consulting expense for the years ended October 31,
−Removed: 2022 and 2021 was approximately $ 434,000 and $ 103,000 , respectively, related to compensation cost for stock options granted in prior
−Removed: periods but not yet vested.
−Removed: As of October 31, 2022, there was unrecognized consulting expense related to non-vested service-based stock
−Removed: options granted to consultants of approximately $ 466,000 , which will be recognized over a weighted-average period of 1.2 years.
+Added: 2022 of approximately $ 221,000
+Added: and $ 434,000 ,
+Added: respectively.
+Added: Included in stock-based consulting expense for the years ended October 31, 2023 and 2022 was approximately $ 209,000
+Added: and $ 434,000 ,
+Added: respectively, related to compensation cost for stock options granted in prior periods but not yet vested.
+Added: As of October 31, 2023, there
+Added: was unrecognized consulting expense related to non-vested service-based stock options granted to consultants of approximately $ 281,000 ,
+Added: which will be recognized over a weighted-average period of 2.5
+Added: BIOSCIENCES, INC.
+Added: AND SUBSIDIARIES
+Added: TO CONSOLIDATED FINANCIAL STATEMENTS
Value Determination
2 unchanged sentences
The stock options we granted during each of the years ended October 31, 2023 and 2022 consisted
−Removed: of awards with 5 -year and 10 -year terms that vest over 12 to 36 months.
+Added: of awards with 5 -year
+Added: terms that vest over 12
following weighted average assumptions were used in estimating the fair value of stock options granted during the years ended October
1 unchanged sentence
OF WEIGHTED AVERAGE ASSUMPTIONS USED IN ESTIMATING FAIR VALUE OF STOCK OPTIONS
−Removed: Ended October 31,
−Removed: Weighted average fair value at grant date Valuation assumptions:
+Added: the Year Ended October 31,
+Added: Weighted average fair value at
+Added: Valuation assumptions:
Expected life (years)
2 unchanged sentences
Expected dividend yield
−Removed: BIOSCIENCES, INC.
−Removed: AND SUBSIDIARIES
−Removed: TO CONSOLIDATED FINANCIAL STATEMENTS
expected term of stock options represents the weighted average period the stock options are expected to remain outstanding.
−Removed: employees and directors, we use the simplified method, which is a weighted average of the vesting term and contractual term, to
−Removed: determine expected term.
−Removed: The simplified method was adopted since we do not believe that historical experience is representative of
−Removed: future performance because of the impact of the changes in our operations.
−Removed: For consultants we use the contract term for expected
−Removed: Under the Black-Scholes pricing model, we estimated the expected volatility of our shares of common stock based upon the
−Removed: historical volatility of our share price over a period of time equal to the expected term of the options.
+Added: For employees
+Added: and directors, we use the simplified method, which is a weighted average of the vesting term and contractual term, to determine expected
+Added: The simplified method was adopted since we do not believe that historical experience is representative of future performance because
+Added: of the impact of the changes in our operations and the change in terms from historical operations.
+Added: For consultants, we use the contract
+Added: term for expected term.
+Added: Under the Black-Scholes pricing model, we estimated the expected volatility of our shares of common stock based
+Added: upon the historical volatility of our share price over a period of time equal to the expected term of the options.
We estimated the risk-free
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
−Removed: expected term of the underlying grants.
−Removed: We made the dividend yield assumption based on our history of not paying cash dividends and
−Removed: our expectation not to pay dividends in the future.
+Added: Treasury note with a term equal to the expected
+Added: term of the underlying grants.
+Added: We made the dividend yield assumption based on our history of not paying cash dividends and our expectation
+Added: not to pay dividends in the future.
ASC 718, the amount of stock-based compensation expense recognized is based on the portion of the awards that are ultimately expected
7 unchanged sentences
the compensation expense that we record under ASC 718 may differ significantly from what we have recorded in the current period.
−Removed: Award Compensation Expense
−Removed: account for stock awards granted to employees, directors and consultants in accordance with ASC 718.
−Removed: On May 8, 2018, a restricted stock
−Removed: award of 1,500,000 shares of common stock was granted to our Chairman, then-President and Chief Executive Officer.
−Removed: The restricted stock award
−Removed: was to vest in its entirety upon achievement of a target trading price of $ 11.00 per share of the Company’s common stock before
−Removed: May 31, 2021 .
−Removed: The restricted stock award did not vest as of May 31, 2021 and expired.
−Removed: For restricted stock awards vesting upon achievement
−Removed: of a price target of our common stock we use a Monte Carlo Simulation in estimating the fair value at grant date and recognize compensation
−Removed: cost over the implied service period (median time to vest).
−Removed: The assumptions used in the Monte Carlo Simulation were stock price on date
−Removed: of grant of $ 3.70 , contract term of 3.06 years, expected volatility of 128.8 % and risk-free interest rate of 2.66 %.
−Removed: We did not record
−Removed: any compensation expense related to the restricted stock award during the years ended October 31, 2022 and 2021.
−Removed: We did not issue any
−Removed: stock awards during the years ended October 31, 2022 and 2021.
−Removed: As of October 31, 2022, there was no unrecognized compensation cost related
−Removed: to the restricted stock awards.
+Added: BIOSCIENCES, INC.
+Added: AND SUBSIDIARIES
+Added: TO CONSOLIDATED FINANCIAL STATEMENTS
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, 2022 and 2021 we recorded consulting expense, based on the fair value, of approximately $ 221,000
−Removed: and $ 96,000 , respectively, for warrants granted to consultants.
+Added: During the years ended October 31, 2023 and 2022 we recorded consulting expense, based on the fair value, of $ 0
+Added: and approximately $ 221,000 ,
+Added: respectively, for warrants granted to consultants.
Loss Per Share of Common Stock
7 unchanged sentences
For this reason, excluded from the calculation of Diluted EPS for the years ended October 31,
−Removed: 2022 and 2021 were options to purchase 10,318,872 shares and 10,770,626 shares, respectively, and warrants to purchase 300,000 shares
−Removed: and 860,000 shares, respectively.
−Removed: BIOSCIENCES, INC.
−Removed: AND SUBSIDIARIES
−Removed: TO CONSOLIDATED FINANCIAL STATEMENTS
+Added: 2023 and 2022 were options to purchase 11,430,000
+Added: shares and 10,318,872
+Added: shares, respectively, and warrants to purchase
+Added: shares and 300,000
+Added: shares, respectively.
preparation of financial statements in conformity with accounting principles generally accepted in the United States of America requires
4 unchanged sentences
results could differ from those estimates.
+Added: BIOSCIENCES, INC.
+Added: AND SUBSIDIARIES
+Added: TO CONSOLIDATED FINANCIAL STATEMENTS
of Recently Issued Pronouncements
−Removed: January 2020, the FASB issued Accounting Standards Update 2020-01 (“ASU 2020-01”) Investments-Equity Securities (Topic 321),
−Removed: Investments-Equity Method and Joint Ventures (Topic 323), and Derivatives and Hedging (Topic 815).
−Removed: The amendments in ASU 2020-01 clarify
−Removed: certain interactions between the guidance to account for certain equity securities under Topic 321, the guidance to account for investments
−Removed: under the equity method of accounting in Topic 323, and the guidance in Topic 815, which could change how an entity accounts for an equity
−Removed: security under the measurement alternative or a forward contract or purchased option to purchase securities that, upon settlement of
−Removed: the forward contract or exercise of the purchased option, would be accounted for under the equity method of accounting or the fair value
−Removed: option in accordance with Topic 825, Financial Instruments.
−Removed: These amendments improve current GAAP by reducing diversity in practice and
−Removed: increasing comparability of the accounting for these interactions.
−Removed: The amendments in this update are effective for fiscal years beginning
−Removed: after December 15, 2020, and interim periods within those fiscal years.
−Removed: The adoption of this standard did not have a material impact
−Removed: on our consolidated financial statements and related disclosures.
August 2020, the FASB issued Accounting Standards Update 2020-06 (“ASU 2020-06”), Accounting for Convertible Instruments
7 unchanged sentences
within those fiscal years.
−Removed: We do not expect the adoption of this standard to have a material impact on our consolidated financial statements
−Removed: and related disclosures.
−Removed: May 2021, the FASB issued Accounting Standards Update 2021-04 (“ASU No.
−Removed: 2021-04”), Issuer’s Accounting for Certain
−Removed: Modifications or Exchanges of Freestanding Equity-Classified Written Call Options.
−Removed: The guidance in ASU 2021-04 requires the issuer to
−Removed: treat a modification of an equity-classified written call option (the “option”) that does not cause the option to become
−Removed: liability-classified as an exchange of the original option for a new option.
−Removed: This guidance applies whether the modification is structured
−Removed: as an amendment to the terms and conditions of the option or as termination of the original option and issuance of a new option.
−Removed: amendments in this update are effective for fiscal years beginning after December 15, 2021, including interim periods within those fiscal
−Removed: We do not expect the adoption of this standard to have a material impact on our consolidated financial statements and related
−Removed: BIOSCIENCES, INC.
−Removed: AND SUBSIDIARIES
−Removed: TO CONSOLIDATED FINANCIAL STATEMENTS
−Removed: October 2021, the FASB issued Accounting Standards Update 2021-08 (“ASU No.
−Removed: 2021-08”), Business Combinations (Topic 805):
−Removed: Accounting for Contract Assets and Contract Liabilities from Contracts with Customers, to require that an acquirer recognize and measure
−Removed: contract assets and contract liabilities acquired in a business combination in accordance with Topic 606, Revenue from Contracts with
−Removed: At the acquisition date, an acquirer should account for the related revenue contracts in accordance with Topic 606 as if it
−Removed: had originated the contracts.
−Removed: The amendments in this update should be applied prospectively and are effective for fiscal years beginning
−Removed: after December 15, 2022, including interim periods within those fiscal years.
−Removed: We do not expect the adoption of this standard to have
−Removed: a material impact on our consolidated financial statements and related disclosures.
+Added: The adoption of this standard did not have a material impact on our consolidated financial statements and
+Added: related disclosures.
+Added: May 2021, the FASB issued Accounting Standards Update 2021-04 (“ASU 2021-04”), Issuer’s Accounting for Certain Modifications
+Added: or Exchanges of Freestanding Equity-Classified Written Call Options.
+Added: The guidance in ASU 2021-04 requires the issuer to treat a modification
+Added: of an equity-classified written call option (the “option”) that does not cause the option to become liability-classified
+Added: as an exchange of the original option for a new option.
+Added: This guidance applies whether the modification is structured as an amendment
+Added: to the terms and conditions of the option or as termination of the original option and issuance of a new option.
+Added: The amendments in this
+Added: update are effective for fiscal years beginning after December 15, 2021, including interim periods within those fiscal years.
+Added: of this standard did not have a material impact on our consolidated financial statements and related disclosures.
+Added: October 2021, the FASB issued Accounting Standards Update 2021-08 (“ASU 2021-08”), Business Combinations (Topic 805):
+Added: for Contract Assets and Contract Liabilities from Contracts with Customers, to require that an acquirer recognize and measure contract
+Added: assets and contract liabilities acquired in a business combination in accordance with Topic 606, Revenue from Contracts with Customers.
+Added: At the acquisition date, an acquirer should account for the related revenue contracts in accordance with Topic 606 as if it had originated
+Added: the contracts.
+Added: The amendments in this update should be applied prospectively and are effective for fiscal years beginning after December
+Added: 15, 2022, including interim periods within those fiscal years.
+Added: We do not expect the adoption of this standard to have a material impact
+Added: on our consolidated financial statements and related disclosures.
Concentration
11 unchanged sentences
during fiscal year 2023.
−Removed: March 25, 2021, the Company completed a public offering in which we sold an aggregate of 4,285,715 shares of its common stock, which
−Removed: represented 15.8 % of the Company’s outstanding shares at the time of the offering, at a public offering price of $ 5.25 per share.
−Removed: The Company realized net proceeds of approximately $ 20,292,000 from the public offering, after deducting underwriting discounts and deal
−Removed: In connection with the public offering, the Company issued to certain designees of the underwriter, as compensation, warrants
−Removed: expiring on March 22, 2026 , to purchase 300,000 shares of common stock exercisable for $ 6.5625 per share.
+Added: ACCRUED EXPENSES
liabilities consist of the following as of:
3 unchanged sentences
Accrued other
−Removed: Accrued expenses
−Removed: SHAREHOLDERS’
+Added: BIOSCIENCES, INC.
+Added: AND SUBSIDIARIES
+Added: TO CONSOLIDATED FINANCIAL STATEMENTS
+Added: SHAREHOLDERS’ EQUITY
the year ended October 31, 2023, we had two stock option plans:
5 unchanged sentences
The 2018 Share Plan was approved by our shareholders on March
−Removed: BIOSCIENCES, INC.
−Removed: AND SUBSIDIARIES
−Removed: TO CONSOLIDATED FINANCIAL STATEMENTS
−Removed: the year ended October 31, 2022, stock options to purchase 793,103 shares, net of 1,083,517 shares withheld on cashless exercises, were
−Removed: exercised with aggregate proceeds of approximately $ 439,000 .
−Removed: During the year ended October 31, 2021, stock options to purchase 207,697
−Removed: shares, net of 60,691 shares withheld on cashless exercises, were exercised with aggregate proceeds of approximately $ 434,000 .
−Removed: 2010 Share Plan provides for the grant of nonqualified stock options, stock appreciation rights, stock awards, performance awards and
+Added: In accordance with the provisions of the 2010 Share Plan, the plan terminated with respect to the grant of future securities
+Added: on July 14, 2020.
+Added: the years ended October 31, 2023 and 2022, stock options to purchase 157,761
+Added: shares of common stock, respectively, were exercised
+Added: on a cash basis, with aggregate proceeds of approximately $ 353,000
+Added: and $ 439,000 ,
+Added: respectively.
+Added: During the years ended October 31, 2023 and 2022, stock options to purchase 161,111
+Added: shares of common stock, of which 116,225
+Added: shares were withheld, and 1,488,881
+Added: shares of common stock, of which 1,083,517
+Added: shares were withheld, were exercised on a cashless
+Added: basis, respectively.
+Added: 2010 Share Plan provided for the grant of nonqualified stock options, stock appreciation rights, stock awards, performance awards and
stock units to employees, directors and consultants.
On the first business day of each calendar year the aggregate number of shares available
−Removed: for future issuance is replenished such that 800,000 shares are available.
−Removed: The exercise price with respect to all of the options granted
−Removed: under the 2010 Share Plan was equal to the fair market value of the underlying common stock at the grant date.
−Removed: In accordance with the
−Removed: provisions of the 2010 Share Plan, the plan terminated with respect to the grant of future options on July 14, 2020.
−Removed: Information regarding
−Removed: the 2010 Share Plan for the two years ended October 31, 2022 is as follows:
+Added: for future issuance was replenished such that 800,000
+Added: shares were available.
+Added: The exercise price with
+Added: 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
+Added: the grant date.
+Added: Information regarding the 2010 Share Plan for the two years ended October 31, 2023 is as follows:
OF OPTION ACTIVITY
−Removed: Average Exercise
−Removed: Price Per Share
−Removed: Aggregate Intrinsic Value
+Added: Exercise Price
+Added: Intrinsic Value
Options Outstanding at October
Options Outstanding at October 31, 2022
−Removed: Options Outstanding and Exercisable at
−Removed: October 31, 2022
+Added: Options Outstanding
+Added: and Exercisable at October 31, 2023
following table summarizes information about stock options outstanding under the 2010 Share Plan as of October 31, 2023:
OF OUTSTANDING AND EXERCISABLE
−Removed: Outstanding and
−Removed: Weighted Average
−Removed: Contractual Life
−Removed: $ 0.67 - $ 2.27
−Removed: $ 3.46 - $ 5.30
+Added: of Exercise Prices
BIOSCIENCES, INC.
4 unchanged sentences
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 shares are available.
−Removed: The exercise price
−Removed: with respect to all of the options granted under the 2018 Share Plan was equal to the fair market value of the underlying common stock
−Removed: at the grant date.
−Removed: As of October 31, 2022, the 2018 Share Plan had 605,134 shares available for future grants.
−Removed: Information regarding
−Removed: the 2018 Share Plan for the two years ended October 31, 2022 is as follows:
+Added: aggregate number of shares available for future issuance is replenished such that 2,000,000
+Added: shares are available.
+Added: The exercise price with
+Added: 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
+Added: the grant date.
+Added: As of October 31, 2023, the 2018 Share Plan had 750,000
+Added: shares available for future grants.
+Added: regarding the 2018 Share Plan for the two years ended October 31, 2023 is as follows:
OF OPTION ACTIVITY
−Removed: Average Exercise
−Removed: Price Per Share
−Removed: Aggregate Intrinsic Value
−Removed: Options Outstanding at October 31, 2020
−Removed: ( 1,392,781 )
+Added: Exercise Price
+Added: Intrinsic Value
Options Outstanding at October
Options Outstanding at October 31, 2022
−Removed: Options Exercisable at October 31, 2022
−Removed: following table summarizes information about stock options outstanding under the 2018 Share Plan as of October 31, 2022:
−Removed: OF OUTSTANDING AND EXERCISABLE
+Added: Forfeited/Expired
Options Outstanding
+Added: at October 31, 2023
Options Exercisable
−Removed: Exercise Prices
−Removed: Contractual Life
−Removed: Contractual Life
−Removed: $ 2.09 -$ 3.87
−Removed: $ 3.96 -$ 5.30
+Added: at October 31, 2023
+Added: following table summarizes information about stock options outstanding under the 2018 Share Plan as of October 31, 2023:
+Added: OF OUTSTANDING AND EXERCISABLE
addition to options granted under stock option plans, during the years ended October 31, 2012 and 2013, the Board of Directors approved
the grant of stock options to certain employees and directors (the “Non-Plan Options”).
+Added: BIOSCIENCES, INC.
+Added: AND SUBSIDIARIES
+Added: TO CONSOLIDATED FINANCIAL STATEMENTS
regarding the Non-Plan Options for the two years ended October 31, 2023 is as follows:
OF OPTION ACTIVITY
−Removed: Average Exercise
−Removed: Price Per Share
−Removed: Options Outstanding at October 31, 2020
+Added: Exercise Price
Options Outstanding October 31,
( 1,642,000 )
−Removed: Options Outstanding and Exercisable at October 31, 2022
−Removed: BIOSCIENCES, INC.
−Removed: AND SUBSIDIARIES
−Removed: TO CONSOLIDATED FINANCIAL STATEMENTS
+Added: Options Outstanding
+Added: and Exercisable at October 31, 2022
Stock Purchase Plan
1 unchanged sentence
Employee Stock Purchase Plan which permits eligible employees to purchase shares at not
−Removed: less than 85 % of the market value of the Company’s common stock on the offering date or the purchase date of the applicable offering
−Removed: period, whichever is lower.
+Added: less than 85 %
+Added: of the market value of the Company’s common stock on the offering date or the purchase date of the applicable offering period,
+Added: whichever is lower.
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, 2022 and 2021, employees purchased 4,741 and 2,377 shares, respectively, with aggregate
−Removed: proceeds of approximately $ 13,000 and $ 6,000 , respectively.
+Added: During the years ended October 31, 2023 and 2022, employees purchased 4,360
+Added: shares, respectively, with aggregate proceeds
+Added: of approximately $ 13,000
+Added: and $ 13,000 ,
+Added: respectively.
Stock Purchase Warrants
−Removed: October 30, 2020 we issued a warrant, expiring on October
+Added: November 1, 2021 we issued a warrant, expiring on October
30, 2026 , to purchase 60,000
1 unchanged sentence
per share, vesting over five
−Removed: months , to a consultant for investor relations services.
+Added: months , to a consultant for investor relations
We recorded consulting expense of approximately $ 221,000
−Removed: during the year ended October 31, 2021, based on the fair value of the warrant recognized on a straight-line basis over the vesting
−Removed: On November 16, 2021, the warrant was exercised in full on a cashless basis and 25,484
−Removed: shares were withheld as payment.
−Removed: November 1, 2021 we issued a warrant, expiring on October 30, 2026 , to purchase 60,000 shares of common stock at $ 4.77 per share, vesting
−Removed: over five months , to a consultant for investor relations services.
−Removed: We recorded consulting expense of approximately $ 221,000 during the
−Removed: year ended October 31, 2022, based on the fair value of the warrant recognized on a straight-line basis over the vesting period.
−Removed: warrant terminated in May 2022 upon termination of the consulting agreement.
−Removed: discussed in Note 3, in connection with the March 25, 2021 public offering, we issued to certain designees of the underwriter, as compensation,
−Removed: warrants to purchase 300,000 shares of common stock at $ 6.5625 per share, expiring on March 22, 2026 .
+Added: during the year ended October 31, 2022, based
+Added: on the fair value of the warrant recognized on a straight-line basis over the vesting period.
+Added: The warrant terminated in May 2022 upon
+Added: termination of the consulting agreement.
+Added: connection with a public offering in March 2021, we issued to certain designees of the underwriter, as compensation, warrants to purchase
+Added: shares of common stock at $ 6.5625
+Added: per share, expiring on March
regarding the Company’s warrants for the two years ended October 31, 2023 is as follows:
OF WARRANTS ACTIVITY
−Removed: Average Exercise
−Removed: Price Per Share
−Removed: Intrinsic Value
−Removed: Warrants Outstanding at October 31, 2020
+Added: Exercise Price
Warrants Outstanding at October
−Removed: Warrants Outstanding and Exercisable at
−Removed: October 31, 2022
+Added: Warrants Outstanding
+Added: and Exercisable at October 31, 2022 and October 31, 2023
+Added: following table summarizes information about the Company’s outstanding and exercisable warrants as of October 31 , 2023:
+Added: OF OUTSTANDING AND EXERCISABLE
BIOSCIENCES, INC.
1 unchanged sentence
TO CONSOLIDATED FINANCIAL STATEMENTS
−Removed: following table summarizes information about the Company’s outstanding and exercisable warrants as of October 31 , 2022:
−Removed: OF OUTSTANDING AND EXERCISABLE
−Removed: Outstanding and
−Removed: Weighted Average
−Removed: Contractual Life
−Removed: Advisors, LLC
−Removed: Advisors, LLC (“ZQX”) was an inactive joint venture in which we held a 19.5 % interest, and which was dissolved during fiscal
−Removed: The only assets of ZQX were shares of our common stock which were sold during fiscal year 2021, for which we received proceeds
+Added: lease approximately 2,000
+Added: square feet of office space at 3150 Almaden Expressway,
+Added: San Jose, California (our principal executive offices) from an unrelated party pursuant to an operating lease that, as amended, will
+Added: expire on September
+Added: 30, 2024 , with an
+Added: option to extend the lease an additional two years.
+Added: base rent is approximately $ 5,000
+Added: per month and the lease provides for annual increases
of approximately 3 %
−Removed: lease approximately 2,000 square feet of office space at 3150 Almaden Expressway, San Jose, California (our principal executive offices)
−Removed: from an unrelated party pursuant to an operating lease that was set to expire on September 30, 2021 .
−Removed: Effective August 17, 2021, the lease
−Removed: was amended to extend the expiration date to September 30, 2024, with an option to extend the lease an additional two years .
−Removed: rent is approximately $ 5,000 per month and the lease provides for annual increases of approximately 3 % and an escalation clause for increases
−Removed: in certain operating costs.
−Removed: The amendment to the lease resulted in a right-of-use asset and lease liability of approximately $ 260,000
+Added: and an escalation clause for increases in certain operating costs.
+Added: The lease, as amended, resulted in a right-of-use asset and lease
+Added: liability of approximately $ 260,000
with a discount rate of 10 %.
−Removed: Rent expense was approximately $ 66,000 and $ 64,000 , respectively, for the years ended October 31, 2022 and
+Added: Rent expense was approximately $ 66,000 for
+Added: each of the years ended October 31, 2023 and 2022.
operating leases, the lease liability is initially and subsequently measured at the present value of the unpaid lease payments.
The remaining
−Removed: 47 month lease term as of October 31, 2022 for the Company’s lease includes the noncancelable period of the lease and the additional
−Removed: two-year option period that the Company believes it is reasonably certain to exercise.
−Removed: All right-of-use assets are reviewed for impairment when indications of
−Removed: impairment are present.
+Added: lease term as of October 31, 2023 for the Company’s lease includes the noncancelable period of the lease and the additional two-year
+Added: option period that the Company believes it is reasonably certain to exercise.
+Added: All right-of-use assets are reviewed for impairment when
+Added: indications of impairment are present.
of October 31, 2023, the annual minimum lease payments of our operating lease liability were as follows (in thousands):
1 unchanged sentence
For Years Ending October 31,
−Removed: Operating Leases
−Removed: Total future minimum lease payments, undiscounted
+Added: Total future minimum lease
+Added: payments, undiscounted
Imputed interest
value of future minimum lease payments
−Removed: AND CONTINGENCIES
+Added: COMMITMENTS AND CONTINGENCIES
than lawsuits we bring to enforce our patent rights, we are not involved in any litigation or other legal proceedings and management
1 unchanged sentence
or financial condition.
−Removed: BIOSCIENCES, INC.
−Removed: AND SUBSIDIARIES
−Removed: TO CONSOLIDATED FINANCIAL STATEMENTS
−Removed: Collaborative
−Removed: Research and License Commitments
−Removed: of October 31, 2022, our commitments under the collaborative and license agreements with Moffitt, Wistar, Cleveland Clinic and MolGenie
−Removed: for the year ending October 31, 2023 were approximately $ 70,000 .
−Removed: of Coronavirus Pandemic
−Removed: extent to which the COVID-19 pandemic impacts our business, operations and financial results will depend on numerous evolving factors
−Removed: that we may not be able to accurately predict, including:
−Removed: the duration and scope of the pandemic;
−Removed: governmental, business and individuals’
−Removed: actions that have been and continue to be taken in response to the pandemic;
−Removed: the impact of the pandemic on economic activity and actions
−Removed: taken in response;
−Removed: our ability to continue daily operations, including as a result of travel restrictions and people working from home;
−Removed: the effect the pandemic may have on the ability to recruit patients to participate in our clinical trials;
−Removed: and any closures of our and
−Removed: our business partners’ offices and facilities.
−Removed: the Company and its partners are not currently experiencing significant negative impact of COVID-19, there can be no assurance that the
−Removed: current situation will continue.
−Removed: Further, events such as natural disasters and public health emergencies divert our attention away from
−Removed: normal operations and limited resources.
−Removed: Our inability to timely resume normal operations following any pandemic disruption could adversely
−Removed: affect our business, financial condition or results of operations in a material manner.
+Added: of October 31, 2023, our commitments under the license agreements with Wistar and Cleveland Clinic for the year ending October 31, 2024
+Added: were approximately $ 70,000 .
+Added: & Development Agreements
+Added: have entered into certain research and development agreements with various third-party vendors related to the manufacturing of materials
+Added: necessary for the expected Phase 2 clinical trial of our breast cancer vaccine.
+Added: As of October 31, 2023, future payments the Company may
+Added: make under these agreements may be approximately $ 3.5 million and such payments may be made over up to a five-year period.
tax provision (benefit) consists of the following:
OF INCOME TAX PROVISION (BENEFIT)
−Removed: Year Ended October 31,
+Added: Ended October 31,
( 1,739,000 )
−Removed: Adjustment to valuation allowance related
−Removed: to net deferred tax assets
−Removed: Income tax provision
+Added: ( 1,021,000 )
+Added: Adjustment to valuation
+Added: allowance related to net deferred tax assets
BIOSCIENCES, INC.
5 unchanged sentences
Long-term deferred tax assets:
−Removed: Federal and state NOL and tax credit carryforwards
+Added: state NOL and tax credit carryforwards
Deferred compensation
2 unchanged sentences
( 29,602,000 )
−Removed: Deferred tax asset, net
−Removed: of October 31, 2022, we had Federal tax net operating loss and tax credit carryforwards of approximately $ 91,947,000 and
−Removed: $ 1,614,000 ,
+Added: tax asset, net
+Added: of October 31, 2023, we had Federal tax net operating loss and tax credit carryforwards of approximately $ 95,752,000
+Added: and $ 1,870,000 ,
respectively.
−Removed: At the federal level, businesses can carry forward their net operating losses indefinitely, but the deductions are
−Removed: limited to 80 percent of taxable income.
−Removed: Prior to the Tax Cuts and Jobs Act (TCJA) of 2017, businesses could carry losses forward
−Removed: for 20 years (without a deductibility limit).
−Removed: If the tax benefits relating to deductions of option holders’ income are
−Removed: ultimately realized, those benefits will be credited directly to additional paid-in capital.
−Removed: Certain changes in stock ownership can
−Removed: result in a limitation on the amount of net operating loss and tax credit carryovers that can be utilized each year.
−Removed: As of October
−Removed: 31, 2022, management has not determined the extent of any such limitations, if any.
−Removed: had California tax net operating loss carryforwards of approximately $ 42,712,000 as of October 31, 2022, available within statutory limits
−Removed: ( expiring at various dates between 2023 and 2042 ), to offset future corporate taxable income and taxes payable, if any, under certain
−Removed: computations of such taxes.
−Removed: have provided a 100 % valuation allowance against our deferred tax asset due to our current and historical pre-tax losses and the
−Removed: uncertainty regarding their realizability.
−Removed: The primary differences from the Federal statutory rate of 21 %
+Added: At the federal level, businesses can carry forward their net operating losses indefinitely, but the deductions are limited
+Added: 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
+Added: (without a deductibility limit).
+Added: If the tax benefits relating to deductions of option holders’ income are ultimately realized,
+Added: those benefits will be credited directly to additional paid-in capital.
+Added: Certain changes in stock ownership can result in a limitation
+Added: on the amount of net operating loss and tax credit carryovers that can be utilized each year.
+Added: As of October 31, 2023, management has
+Added: not determined the extent of any such limitations, if any.
+Added: had California tax net operating loss carryforwards of approximately $ 51,065,000
+Added: as of October 31, 2023, available within statutory
+Added: limits ( expiring
+Added: at various dates between 2024 and 2043 ), to offset
+Added: future corporate taxable income and taxes payable, if any, under certain computations of such taxes.
+Added: have provided a 100 %
+Added: valuation allowance against our deferred tax
+Added: asset due to our current and historical pre-tax losses and the uncertainty regarding their realizability.
+Added: The primary differences from
+Added: the Federal statutory rate of 21 %
and the effective rate of 0 %
is attributable to expiring net operating losses and a change in the valuation allowance.
−Removed: The following is a reconciliation of
−Removed: income taxes at the Federal statutory tax rate to income tax expense (benefit):
+Added: The following is a reconciliation of income
+Added: taxes at the Federal statutory tax rate to income tax expense (benefit):
OF RECONCILIATION OF INCOME TAXES
−Removed: Year Ended October 31,
+Added: Ended October 31,
Income tax benefit at U.S.
−Removed: Federal statutory income tax rate
+Added: statutory income tax rate
( 2,085,000 )
2 unchanged sentences
Permanent differences
−Removed: Expiring net operating losses, credits and other
−Removed: Change in valuation allowance
−Removed: Income tax provision
−Removed: the two fiscal years ended October 31, 2022, we incurred no Federal and no State income taxes.
−Removed: We have no unrecognized tax benefits as
−Removed: of October 31, 2022 and 2021 and we account for interest and penalties related to income tax matters in general and administrative expenses.
−Removed: Tax years to which our net operating losses relate remain open to examination by Federal and California authorities to the extent which
−Removed: the net operating losses have yet to be utilized.
+Added: Expiring net operating losses, credits and
+Added: Change in valuation
+Added: tax provision
BIOSCIENCES, INC.
1 unchanged sentence
TO CONSOLIDATED FINANCIAL STATEMENTS
+Added: the two fiscal years ended October 31, 2023, we incurred no Federal and no State income taxes.
+Added: unrecognized tax benefits as of October 31, 2023
+Added: and 2022 and we account for interest and penalties related to income tax matters in general and administrative expenses.
+Added: which our net operating losses relate remain open to examination by Federal and California authorities to the extent which the net operating
+Added: losses have yet to be utilized.
+Added: SEGMENT INFORMATION
follow the accounting guidance of ASC 280, Segment Reporting (“ASC 280”).
4 unchanged sentences
While our results of operations
−Removed: are primarily reviewed on a consolidated basis, the chief operating decision-maker manages the enterprise in four reportable segments,
−Removed: each with different operating and potential revenue generating characteristics:
−Removed: (i) CAR-T Therapeutics, (ii) Cancer Vaccines, (iii) Anti-Viral
−Removed: Therapeutics and (iv) Other.
−Removed: The following represents selected financial information for our segments for the years ended October 31,
−Removed: 2022 and 2021:
+Added: are primarily reviewed on a consolidated basis, the chief operating decision-maker manages the enterprise in four
+Added: reportable segments, each with different operating
+Added: and potential revenue generating characteristics:
+Added: (i) CAR-T Therapeutics, (ii) Cancer Vaccines, (iii) Anti-Viral Therapeutics and (iv)
+Added: The following represents selected financial information for our segments for the years ended October 31, 2023 and 2022:
OF SEGMENT INFORMATION
−Removed: Year Ended October 31,
+Added: Ended October 31,
Net income (loss):
2 unchanged sentences
Anti-Viral Therapeutics
−Removed: Net income (loss)
+Added: income (loss)
Total operating costs and expenses
−Removed: Less non-cash share-based compensation
−Removed: Operating costs and expenses excluding non-cash share-based compensation
−Removed: Operating costs and expenses excluding non-cash share based compensation:
+Added: Less non-cash share-based
+Added: costs and expenses excluding non-cash share-based compensation
+Added: Operating costs and expenses excluding non-cash
+Added: share based compensation:
CAR-T Therapeutics
1 unchanged sentence
Anti-Viral Therapeutics
−Removed: Operating costs and expenses excluding non-cash share based compensation
+Added: costs and expenses excluding non-cash share based compensation
Total assets:
4 unchanged sentences
the enterprise.
−Removed: Company’s consolidated revenue of $ 512,000 and inventor royalties, contingent legal fees, litigation and licensing expense of $ 385,000 ,
−Removed: for the year ended October 31, 2021 were solely related to our patent licensing segment.
−Removed: All our revenue is generated domestically (United
−Removed: States) based on the country in which the licensee is located.
+Added: Company’s consolidated revenue of $ 210,000
+Added: and inventor royalties, contingent legal fees, litigation and
+Added: licensing expense of $ 161,000 ,
+Added: for the year ended October 31, 2023 were solely related to our other segment.
+Added: All our revenue is generated domestically (United States)
+Added: 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.