Document and Entity Information
Document and Entity Information - USD ($) | 12 Months Ended | ||
Oct. 31, 2019 | Dec. 16, 2019 | Apr. 30, 2019 | |
Document And Entity Information | |||
Entity Registrant Name | Advaxis, Inc. | ||
Entity Central Index Key | 0001100397 | ||
Document Type | 10-K | ||
Document Period End Date | Oct. 31, 2019 | ||
Amendment Flag | false | ||
Current Fiscal Year End Date | --10-31 | ||
Entity Well-known Seasoned Issuer | No | ||
Entity Voluntary Filers | No | ||
Entity Current Reporting Status | Yes | ||
Entity Interactive Data Current | Yes | ||
Entity Filer Category | Non-accelerated Filer | ||
Entity Small Business Flag | true | ||
Entity Emerging Growth Company | false | ||
Entity Ex Transition Period | false | ||
Entity Shell Company | false | ||
Entity Public Float | $ 28,098,000 | ||
Entity Common Stock, Shares Outstanding | 50,211,424 | ||
Document Fiscal Period Focus | FY | ||
Document Fiscal Year Focus | 2019 |
Balance Sheets
Balance Sheets - USD ($) $ in Thousands | Oct. 31, 2019 | Oct. 31, 2018 |
Current assets: | ||
Cash and cash equivalents | $ 32,363 | $ 44,141 |
Restricted cash | 977 | |
Accounts receivable | 1,664 | |
Deferred expenses | 2,353 | 2,072 |
Prepaid expenses and other current assets | 1,433 | 1,611 |
Total current assets | 36,149 | 50,465 |
Property and equipment (net of accumulated depreciation) | 4,350 | 6,684 |
Intangible assets (net of accumulated amortization) | 4,575 | 4,838 |
Other assets | 183 | 280 |
Total assets | 45,257 | 62,267 |
Current liabilities: | ||
Accounts payable | 976 | 5,646 |
Accrued expenses | 3,478 | 6,185 |
Deferred revenue | 4,476 | |
Common stock warrant liability | 19 | 6,517 |
Other current liabilities | 48 | 48 |
Total current liabilities | 4,521 | 22,872 |
Deferred revenue - net of current portion | 14,189 | |
Other liabilities | 1,205 | 1,155 |
Total liabilities | 5,726 | 38,216 |
Commitments and contingencies - Note 9 | ||
Stockholders' equity: | ||
Preferred stock, $0.001 par value; 5,000,000 shares authorized; Series B Preferred Stock; 0 shares issued and outstanding at October 31, 2019 and 2018. Liquidation preference of $0 at October 31, 2019 and 2018. | ||
Common stock - $0.001 par value; 170,000,000 shares authorized, 50,201,671 and 4,634,189 shares issued and outstanding at October 31, 2019 and 2018. | 50 | 5 |
Additional paid-in capital | 423,750 | 391,703 |
Accumulated deficit | (384,269) | (367,657) |
Total stockholders' equity | 39,531 | 24,051 |
Total liabilities and stockholders' equity | $ 45,257 | $ 62,267 |
Balance Sheets (Parenthetical)
Balance Sheets (Parenthetical) - USD ($) $ in Thousands | Oct. 31, 2019 | Oct. 31, 2018 |
Statement of Financial Position [Abstract] | ||
Preferred stock, par value | $ 0.001 | $ 0.001 |
Preferred stock, shares authorized | 5,000,000 | 5,000,000 |
Series B Preferred stock, shares issued | 0 | 0 |
Series B Preferred stock, shares outstanding | 0 | 0 |
Preferred stock, liquidation preference value | $ 0 | $ 0 |
Common stock, par value | $ 0.001 | $ 0.001 |
Common stock, shares authorized | 170,000,000 | 170,000,000 |
Common stock, shares issued | 50,201,671 | 4,634,189 |
Common stock, shares outstanding | 50,201,671 | 4,634,189 |
Statements of Operations
Statements of Operations - USD ($) $ in Thousands | 12 Months Ended | |
Oct. 31, 2019 | Oct. 31, 2018 | |
Income Statement [Abstract] | ||
Revenue | $ 20,884 | $ 6,063 |
Operating expenses: | ||
Research and development expenses | 26,677 | 56,970 |
General and administrative expenses | 12,179 | 19,472 |
Total operating expenses | 38,856 | 76,442 |
Loss from operations | (17,972) | (70,379) |
Other income (expense): | ||
Interest income | 435 | 577 |
Net changes in fair value of derivative liabilities | 2,589 | 3,400 |
Loss on shares issued in settlement of warrants | (1,607) | |
Other expense | (7) | (63) |
Net loss before income tax benefit | (16,562) | (66,465) |
Income tax expense | 50 | 50 |
Net loss | $ (16,612) | $ (66,515) |
Net loss per common share, basic and diluted | $ (1.09) | $ (19.36) |
Weighted average number of common shares outstanding, basic and diluted | 15,207,637 | 3,434,824 |
Statements of Stockholders' Equ
Statements of Stockholders' Equity - USD ($) $ in Thousands | Preferred Stock [Member] | Common Stock [Member] | Additional Paid-In Capital [Member] | Accumulated Deficit [Member] | Total |
Balance at Oct. 31, 2017 | $ 3 | $ 355,399 | $ (301,142) | $ 54,260 | |
Balance, shares at Oct. 31, 2017 | 2,744,196 | ||||
Stock-based compensation | 7,028 | 7,028 | |||
Stock-based compensation, shares | 50,828 | ||||
Tax withholdings paid related to net share settlement of equity awards | (87) | (87) | |||
Tax withholdings paid on equity awards | (474) | (474) | |||
Tax shares sold to pay for tax withholdings on equity awards | 460 | 460 | |||
Issuance of shares to employees under ESPP Plan | 43 | 43 | |||
Issuance of shares to employees under ESPP Plan, shares | 2,611 | ||||
ESPP Expense | 7 | 7 | |||
Advaxis at-the-market sales | 2,659 | 2,659 | |||
Advaxis at-the-market sales, shares | 58,776 | ||||
Advaxis public offerings | $ 2 | 26,668 | 26,670 | ||
Advaxis public offerings, shares | 1,777,778 | ||||
Net Loss | (66,515) | (66,515) | |||
Balance at Oct. 31, 2018 | $ 5 | 391,703 | (367,657) | 24,051 | |
Balance, shares at Oct. 31, 2018 | 4,634,189 | ||||
Stock-based compensation | 2,002 | 2,002 | |||
Stock-based compensation, shares | 12,220 | ||||
Tax withholdings paid on equity awards | (15) | (15) | |||
Tax shares sold to pay for tax withholdings on equity awards | 14 | 14 | |||
Issuance of shares to employees under ESPP Plan | 20 | 20 | |||
Issuance of shares to employees under ESPP Plan, shares | 7,435 | ||||
ESPP Expense | 2 | 2 | |||
Advaxis public offerings | $ 13 | 24,458 | $ 24,471 | ||
Advaxis public offerings, shares | 13,150,000 | 17,869,662 | |||
Pre-funded warrant exercises | $ 13 | $ 13 | |||
Pre-funded warrant exercises, shares | 13,656,000 | ||||
Warrant exercises | $ 18 | 104 | 122 | ||
Warrant exercises, shares | 17,884,962 | ||||
Warrant exchange | $ 1 | 5,462 | 5,463 | ||
Warrant exchange, shares | 856,865 | ||||
Net Loss | (16,612) | (16,612) | |||
Balance at Oct. 31, 2019 | $ 50 | $ 423,750 | $ (384,269) | $ 39,531 | |
Balance, shares at Oct. 31, 2019 | 50,201,671 |
Statement of Cash Flows
Statement of Cash Flows - USD ($) $ in Thousands | 12 Months Ended | |
Oct. 31, 2019 | Oct. 31, 2018 | |
OPERATING ACTIVITIES | ||
Net loss | $ (16,612) | $ (66,515) |
Adjustments to reconcile net loss to net cash used in operating activities: | ||
Stock compensation | 2,002 | 6,983 |
Employee stock purchase plan expense | 3 | 7 |
Gain on change in value of warrants | (2,589) | (3,400) |
Loss on shares issued in settlement of warrants | 1,607 | |
Loss on disposal of property and equipment | 344 | 614 |
Loss on write-down of property and equipment | 943 | |
Abandonment of intangible assets | 1,104 | 1,047 |
Depreciation expense | 1,097 | 1,113 |
Amortization expense of intangible assets | 386 | 388 |
Net accretion of premiums | (6) | |
Change in operating assets and liabilities: | ||
Accounts Receivable | 1,664 | (153) |
Prepaid expenses and other current assets | (103) | 836 |
Income taxes receivable | 4,453 | |
Other assets | 18 | 151 |
Accounts payable and accrued expenses | (7,377) | (1,954) |
Deferred revenue | (18,665) | (5,809) |
Other liabilities | 50 | 116 |
Net cash used in operating activities | (36,128) | (62,129) |
INVESTING ACTIVITIES | ||
Purchases of short-term investment securities | (12,487) | |
Proceeds from maturities of short-term investment securities | 58,891 | |
Purchase of property and equipment | (54) | (1,425) |
Proceeds from disposal of property and equipment | 83 | |
Cost of intangible assets | (1,227) | (1,416) |
Net cash (used in) provided by investing activities | (1,198) | 43,563 |
FINANCING ACTIVITIES | ||
Net proceeds of issuance of common stock and pre-funded warrants | 24,471 | 39,246 |
Warrant exercises | 68 | |
Pre-funded warrant exercises | 13 | |
Proceeds from employee stock purchase plan | 20 | 52 |
Tax withholdings paid related to net share settlement of equity awards | (87) | |
Employee tax withholdings paid on equity awards | (15) | (474) |
Tax shares sold to pay for employee tax withholdings on equity awards | 14 | 460 |
Net cash provided by financing activities | 24,571 | 39,197 |
Net (decrease) increase in cash, cash equivalents and restricted cash | (12,755) | 20,631 |
Cash, cash equivalents and restricted cash at beginning of year | 45,118 | 24,487 |
Cash, cash equivalents and restricted cash at end of year | 32,363 | 45,118 |
The following table provides a reconciliation of cash, cash equivalents and restricted cash reported within the balance sheets that sum to the total of the same such amounts shown in the statements of cash flows: | ||
Cash and cash equivalents | 32,363 | 44,141 |
Restricted cash | 977 | |
Total cash, cash equivalents and restricted cash shown in statements of cash flows | 32,363 | 45,118 |
Supplemental Disclosures of Cash Flow Information | ||
Cash paid for taxes | 50 | 50 |
Supplemental Schedule of Noncash Investing and Financing Activities | ||
Shares issued in settlement of warrants | 5,463 | |
Warrant liability reclassified into equity | 54 | |
Reclass of security deposit to property and equipment for delivered equipment | $ 79 |
Nature of Operations and Basis
Nature of Operations and Basis of Presentation | 12 Months Ended |
Oct. 31, 2019 | |
Organization, Consolidation and Presentation of Financial Statements [Abstract] | |
Nature of Operations and Basis of Presentation | 1. NATURE OF OPERATIONS AND BASIS OF PRESENTATION Advaxis, Inc. (“Advaxis” or the “Company”) is a clinical-stage biotechnology company focused on the development and commercialization of proprietary Listeria monocytogenes Lm Lm Lm Lm TM ● Alerting and training the immune system by activating multiple pathways in Antigen-Presenting Cells (“APCs”) with the equivalent of multiple adjuvants; ● Attacking the tumor by generating a strong, cancer-specific T cell response; and ● Breaking down tumor protection through suppression of the protective cells in the tumor microenvironment (“TME”) that shields the tumor from the immune system. This enables the activated T cells to begin working to attack the tumor cells. Advaxis’ proprietary Lm Lm In June 2019, Advaxis announced that it is closing the AIM2CERV Phase 3 clinical trial with axalimogene filolisbac (AXAL) in high-risk locally advanced cervical cancer and in October 2019, Advaxis announced that it has enrolled its last patient in its ADXS-NEO program in monotherapy and will not continue into Part B of this study. Going Concern and Managements Plans The Company has not yet commercialized any human products and the products that are being developed have not generated significant revenue. As a result, the Company has suffered recurring losses and requires significant cash resources to execute its business plans. These losses are expected to continue for an extended period of time. The aforementioned factors raise substantial doubt about the Company’s ability to continue as a going concern within one year from the date of filing. The accompanying financial statements have been prepared on a going concern basis, which contemplates the realization of assets and the satisfaction of liabilities in the normal course of business. The financial statements do not include any adjustments relating to the recoverability and classification of asset amounts or the classification of liabilities that might be necessary should the Company be unable to continue as a going concern within one year after the date the financial statements are issued. Historically, the Company’s major sources of cash have been comprised of proceeds from various public and private offerings of its common stock, clinical collaborations, option and warrant exercises, and interest income. From October 2013 through October 2019, the Company raised approximately $292.2 million in gross proceeds ($27.0 million in fiscal year 2019) from various public and private offerings of its common stock. As of October 31, 2019, the Company had approximately $32.4 million in cash and cash equivalents. Although the Company believes that it expects to have sufficient capital to fund its obligations, as they become due, in the ordinary course of business until at least January 2021, the actual amount of cash that it will need to operate is subject to many factors. Management’s plans to mitigate an expected shortfall of capital and to support future operations include obtaining additional funds through partnerships or strategic or financing investors. The Company has reduced its operating expenses to $38.9 million for the year ended October 31, 2019 as compared to $76.4 million during the comparable prior period. Furthermore, the Company expects operating expenses to be approximately $29 million for fiscal year 2020, which includes approximately $6 million in non-recurring costs related to programs that are winding down. The Company recognizes it will need to raise additional capital in order to continue to execute its business plan in the future. There is no assurance that additional financing will be available when needed or that management will be able to obtain financing on terms acceptable to the Company or whether the Company will become profitable and generate positive operating cash flow. If the Company is unable to raise sufficient additional funds, it will have to scale back its operations. |
Summary of Significant Accounti
Summary of Significant Accounting Policies | 12 Months Ended |
Oct. 31, 2019 | |
Accounting Policies [Abstract] | |
Summary of Significant Accounting Policies | 2. SUMMARY OF SIGNIFICANT ACCOUNTING POLICIES Estimates The preparation of financial statements in conformity with accounting principles generally accepted in the United States of America (“U.S. GAAP”) requires management to make estimates and assumptions that affect the amounts reported in the financial statements and accompanying notes. Estimates are used when accounting for such items as the fair value and recoverability of the carrying value of property and equipment and intangible assets (patents and licenses), deferred expenses and deferred revenue, the fair value of options, warrants and related disclosure of contingent assets and liabilities. On an on-going basis, the Company evaluates its estimates, based on historical experience and on various other assumptions that it believes to be reasonable under the circumstances. Actual results may or may not differ from estimates. Reclassification Certain amounts in the prior period financial statements have been reclassified to confirm to the presentation of the current period financial statements. The reclassifications had no effect on the previously reported net loss . Revenue Recognition Effective November 1, 2018, the Company adopted ASC Topic 606, Revenue form Contracts with Customers (ASC 606), using the modified retrospective transition method. Under this method, results for reporting periods beginning on November 1, 2018 are presented under ASC 606, while prior period amounts are not adjusted and continue to be reported in accordance with ASC Topic 605, Revenue Recognition The Company enters into licensing agreements that are within the scope of ASC 606, under which it may exclusively license rights to research, develop, manufacture and commercialize its product candidates to third parties. The terms of these arrangements typically include payment to the Company of one or more of the following: non-refundable, upfront license fees; reimbursement of certain costs; customer option exercise fees; development, regulatory and commercial milestone payments; and royalties on net sales of licensed products. In determining the appropriate amount of revenue to be recognized as it fulfills its obligations under its agreements, the Company performs the following steps: (i) identification of the promised goods or services in the contract; (ii) determination of whether the promised goods or services are performance obligations including whether they are distinct in the context of the contract; (iii) measurement of the transaction price, including the constraint on variable consideration; (iv) allocation of the transaction price to the performance obligations; and (v) recognition of revenue when (or as) the Company satisfies each performance obligation. As part of the accounting for these arrangements, the Company must use significant judgment to determine: (a) the number of performance obligations based on the determination under step (ii) above; (b) the transaction price under step (iii) above; and (c) the stand-alone selling price for each performance obligation identified in the contract for the allocation of transaction price in step (iv) above. The Company uses judgment to determine whether milestones or other variable consideration, except for royalties, should be included in the transaction price as described further below. The transaction price is allocated to each performance obligation on a relative stand-alone selling price basis, for which the Company recognizes revenue as or when the performance obligations under the contract are satisfied. Amounts received prior to revenue recognition are recorded as deferred revenue. Amounts expected to be recognized as revenue within the 12 months following the balance sheet date are classified as current portion of deferred revenue in the accompanying balance sheets. Amounts not expected to be recognized as revenue within the 12 months following the balance sheet date are classified as deferred revenue, net of current portion. Exclusive Licenses. Research and Development Services. Milestone Payments. Royalties. Collaborative Arrangements The Company analyzes its collaboration arrangements to assess whether such arrangements involve joint operating activities performed by parties that are both active participants in the activities and exposed to significant risks and rewards dependent on the commercial success of such activities and therefore within the scope of ASC Topic 808, Collaborative Arrangements Cash and Cash Equivalents The Company considers all highly liquid investments with an original maturity of three months or less from the date of purchase to be cash equivalents. Concentration of Credit Risk The Company maintains its cash in bank deposit accounts (checking) that at times exceed federally insured limits. Approximately $30.9 million is subject to credit risk at October 31, 2019. However, these cash balances are maintained at creditworthy financial institutions. The Company has not experienced any losses in such accounts and believes it is not exposed to any significant credit risk. Restricted Cash and Letter of Credit During July 2017 and January 2018, the Company established two letters of credit with a financial institution as security for the purchase of custom equipment and as security for application fees associated with the Company’s Marketing Authorization Application (“MAA”) in Europe. The letters of credit were collateralized by cash which was unavailable for withdrawal or for usage for general obligations. During the year ended October 31, 2019, the two letters of credit were terminated and as of October 31, 2019 the Company has no restricted cash balance. Deferred Expenses Deferred expenses consist of advanced payments made on research and development projects. Expense is recognized in the Statement of Operations as the research and development activity is performed. Property and Equipment Property and equipment is stated at cost. Additions and improvements that extend the lives of the assets are capitalized, while expenditures for repairs and maintenance are expensed as incurred. Leasehold improvements are amortized on a straight-line basis over the shorter of the asset’s estimated useful life or the remaining lease term. Depreciation is calculated on a straight-line basis over the estimated useful lives of the assets ranging from three to ten years. When depreciable assets are retired or sold the cost and related accumulated depreciation are removed from the accounts and any resulting gain or loss is recognized in operations. Intangible Assets Intangible assets are recorded at cost and include patents and patent application costs, licenses and software. Intangible assets are amortized on a straight-line basis over their estimated useful lives ranging from 3 to 20 years. Patent application costs are written-off if the application is rejected, withdrawn or abandoned. Impairment of Long-Lived Assets The Company reviews its long-lived assets, including property and equipment and intangible assets, for impairment whenever events and circumstances indicate that the carrying value of an asset might not be recoverable. Recoverability of assets held and used is measured by comparison of the carrying amount of an asset to the future undiscounted cash flows expected to be generated from the use of the asset and its eventual disposition. If the total of the undiscounted future cash flows is less than the carrying amount of those assets, an impairment loss is recognized in the Statement of Operations based on the excess of the carrying amount over the fair value of the asset. Net Income (Loss) per Share Basic net income or loss per common share is computed by dividing net income or loss available to common shareholders by the weighted average number of common shares outstanding during the period. Diluted earnings per share give effect to dilutive options, warrants, convertible debt and other potential common stock outstanding during the period. In the case of a net loss the impact of the potential common stock resulting from warrants, outstanding stock options and convertible debt are not included in the computation of diluted loss per share, as the effect would be anti-dilutive. In the case of net income, the impact of the potential common stock resulting from these instruments that have intrinsic value are included in the diluted earnings per share. The table sets forth the number of potential shares of common stock that have been excluded from diluted net loss per share. As of October 31, 2019 2018 Warrants 432,142 944,635 Stock options 560,490 330,071 Restricted stock units 14,706 32,614 Total 1,007,338 1,307,320 Research and Development Expenses Research and development costs are expensed as incurred and include but are not limited to clinical trial and related manufacturing costs, payroll and personnel expenses, lab expenses, and related overhead costs. Stock Based Compensation The Company has an equity plan which allows for the granting of stock options to its employees, directors and consultants for a fixed number of shares with an exercise price equal to the fair value of the shares at date of grant. The Company measures the cost of services received in exchange for an award of equity instruments based on the fair value of the award. The fair value of the award is measured on the grant date and is then recognized over the requisite service period, usually the vesting period, in both research and development expenses and general and administrative expenses on the statement of operations, depending on the nature of the services provided by the employees or consultants. The process of estimating the fair value of stock-based compensation awards and recognizing stock-based compensation cost over their requisite service period involves significant assumptions and judgments. The Company estimates the fair value of stock option awards on the date of grant using the Black Scholes Model (“BSM”) for the remaining awards, which requires that the Company makes certain assumptions regarding: (i) the expected volatility in the market price of its common stock; (ii) dividend yield; (iii) risk-free interest rates; and (iv) the period of time employees are expected to hold the award prior to exercise (referred to as the expected holding period). As a result, if the Company revises its assumptions and estimates, stock-based compensation expense could change materially for future grants. The Company accounts for stock-based compensation using fair value recognition and records forfeitures as they occur. As such, the Company recognizes stock-based compensation cost only for those stock-based awards that vest over their requisite service period, based on the vesting provisions of the individual grants. Fair Value of Financial Instruments The carrying value of financial instruments, including cash and cash equivalents, restricted cash and accounts payable approximated fair value as of the balance sheet date presented, due to their short maturities. Derivative Financial Instruments The Company does not use derivative instruments to hedge exposures to cash flow, market or foreign currency risks. The Company evaluates all of its financial instruments to determine if such instruments are derivatives or contain features that qualify as embedded derivatives. For derivative financial instruments that are accounted for as liabilities, the derivative instrument is initially recorded at its fair value and is then re-valued at each reporting date, with changes in the fair value reported in the statements of operations. For stock-based derivative financial instruments, the Company used the Monte Carlo simulation model to value the derivative instruments at inception and on subsequent valuation dates. The classification of derivative instruments, including whether such instruments should be recorded as liabilities or as equity, is evaluated at the end of each reporting period. Derivative liabilities are classified in the balance sheet as current or non-current based on whether or not net-cash settlement of the instrument could be required within 12 months of the balance sheet date. Income Taxes The Company uses the asset and liability method of accounting for income taxes in accordance with ASC Topic 740, “Income Taxes.” Under this method, income tax expense is recognized for the amount of: (i) taxes payable or refundable for the current year and (ii) deferred tax consequences of temporary differences resulting from matters that have been recognized in an entity’s financial statements or tax returns. Deferred tax assets and liabilities are measured using enacted tax rates expected to apply to taxable income in the years in which those temporary differences are expected to be recovered or settled. The effect on deferred tax assets and liabilities of a change in tax rates is recognized in the results of operations in the period that includes the enactment date. A valuation allowance is provided to reduce the deferred tax assets reported if based on the weight of the available positive and negative evidence, it is more likely than not some portion or all of the deferred tax assets will not be realized. Recent Accounting Standards In February 2016, the Financial Accounting Standards Board, (“FASB”), issued Accounting Standards Update, (“ASU”), No. 2016-02, Leases (Topic 842), which establishes a comprehensive new lease accounting model. The new standard: (a) clarifies the definition of a lease; (b) requires a dual approach to lease classification similar to current lease classifications; and (c) causes lessees to recognize leases on the balance sheet as a lease liability with a corresponding right-of-use asset for leases with a lease-term of more than 12 months. The new standard is effective for fiscal years and interim periods beginning after December 15, 2018, with early adoption permitted. A modified retrospective transition approach is required for leases existing at, or entered into after, the beginning of the earliest comparative period presented in the financial statements, including a number of optional practical expedients that entities may elect to apply. In July 2018, the FASB issued ASU No. 2018-11, Leases (Topic 842): Targeted Improvements, an update which provides another transition method, in addition to the existing modified retrospective transition method, by allowing entities to initially apply the new lease standard at the adoption date and recognize a cumulative-effect adjustment to the opening balance of retained earnings in the period of adoption. The Company adopted Topic 842 effective November 1, 2019 using a modified retrospective method and will not restate comparative periods. Upon adoption, the Company recorded a right-to-use asset of approximately $5.3 million and a corresponding lease liability of approximately $6.6 million on the Company’s balance sheet with the difference relating to reclassifications of the deferred rent liability and lease incentive obligation as reductions to the right-of-use asset for its operating lease. Adoption of the new lease standard will not have a significant impact on the Company’s statement of operations. Recently Adopted Accounting Standards In May 2014, FASB issued ASU No. 2014-09, which amends the guidance for accounting for revenue from contracts with customers. ASU No. 2014-09 superseded the revenue recognition requirements in ASC 605 and created ASC 606 described above. In 2015 and 2016, the FASB issued additional ASUs related to ASC 606 that delayed the effective date of the guidance and clarified various aspects of the new revenue guidance, including principal versus agent considerations, identifying performance obligations, and licensing, and they include other improvements and practical expedients. Effective November 1, 2018, the Company adopted ASC 606 using the modified retrospective transition method. As a result of adopting ASC 606, the Company made reclassifications to the balance sheet and income statement. Net income (loss) was not impacted by the adoption of ASC 606. A summary of the amount by which each financial statement line item was affected by the impact of the cumulative adjustment is set forth in the table below (in thousands): Impact of ASC 606 Adoption on (in thousands) As reported Adjustments Balances without adoption of ASC 606 Accounts receivable $ 1,664 $ 1,664 $ - Prepaid expenses and other current assets $ 1,611 $ (1,664 ) $ 3,275 A summary of the amount by which each financial statement line item was affected in the current reporting period by ASC 606 as compared with the guidance that was in effect prior to the adoption of ASC 606 is set forth in the tables below. Impact of ASC 606 Adoption on (in thousands) As reported Adjustments Balances without adoption of ASC 606 Accounts receivable $ - $ - $ - Prepaid expenses and other current assets $ 1,433 $ - $ 1,433 Impact of ASC 606 Adoption on (in thousands) As reported under ASC 606 Adjustments Balances without adoption of ASC 606 Revenue $ 20,884 $ 1,960 $ 18,924 Research and Development Expenses $ 30,320 $ 1,960 $ 28,360 Impact of ASC 606 Adoption on (in thousands) As reported under ASC 606 Adjustments Balances without adoption of ASC 606 Accounts receivable $ - $ - $ - Prepaid expenses and other current assets $ 1,433 - 1,433 The most significant change to the Company’s accounting for revenue as a result of the adoption of ASC 606 relates to its treatment of clinical development payments it receives in its collaboration and licensing agreement with Amgen, Inc. (“Amgen”). Under ASC 605, the Company accounted for the clinical development payments as a reduction of research and development expenses in the statement of operations. Under ASC 606, the Company accounted for the reimbursements for research and development costs as revenue. For further discussion of the adoption of this standard, see Note 8. In November 2018, the FASB issued ASU No. 2018-18, “Collaborative Arrangements (Topic 808)—Clarifying the Interaction between Topic 808 and Topic 606” (“ASU 2018-18”). The amendments in ASU 2018-18 make targeted improvements to generally accepted accounting principles (GAAP) for collaborative arrangements by clarifying that certain transactions between collaborative arrangement participants should be accounted for as revenue under Topic 606 when the collaborative arrangement participant is a customer in the context of a unit of account. In those situations, all the guidance in Topic 606 should be applied, including recognition, measurement, presentation, and disclosure requirements. In addition, unit-of-account guidance in Topic 808 was aligned with the guidance in Topic 606 (that is, a distinct good or service) when an entity is assessing whether the collaborative arrangement or a part of the arrangement is within the scope of Topic 606. ASU 2018-18 is effective for fiscal years beginning after December 15, 2019, and interim periods within those fiscal years. Early adoption is permitted, including adoption in any interim period. The amendments should be applied retrospectively to the date of initial application of Topic 606. The Company adopted this guidance effective November 1, 2018 using the modified retrospective approach. There was no impact on the Company’s financial statements. In June 2018, the FASB issued ASU No. 2018-07, “Compensation—Stock Compensation (Topic 718) —Improvements to Nonemployee Share-Based Payment Accounting” (“ASU 2018-07”). The amendments in ASU 2018-07 expand the scope of Topic 718 to include share-based payment transactions for acquiring goods and services from nonemployees. An entity should apply the requirements of Topic 718 to nonemployee awards except for specific guidance on inputs to an option pricing model and the attribution of cost (that is, the period of time over which share-based payment awards vest and the pattern of cost recognition over that period). The amendments specify that Topic 718 applies to all share-based payment transactions in which a grantor acquires goods or services to be used or consumed in a grantor’s own operations by issuing share-based payment awards. The amendments also clarify that Topic 718 does not apply to share-based payments used to effectively provide (1) financing to the issuer or (2) awards granted in conjunction with selling goods or services to customers as part of a contract accounted for under Topic 606, Revenue from Contracts with Customers. ASU 2018-07 is effective for public business entities for fiscal years beginning after December 15, 2018, including interim periods within that fiscal year. Early adoption is permitted, but no earlier than an entity’s adoption date of Topic 606. The Company adopted this guidance effective as of February 1, 2019. There was no impact on the Company’s financial statements. In November 2016, the FASB issued ASU No. 2016-18, Restricted Cash Management does not believe that any other recently issued, but not yet effective accounting pronouncements, if adopted, would have a material impact on the accompanying financial statements. |
Property and Equipment
Property and Equipment | 12 Months Ended |
Oct. 31, 2019 | |
Property, Plant and Equipment [Abstract] | |
Property and Equipment | 3. PROPERTY AND EQUIPMENT Property and equipment consists of the following (in thousands): October 31, 2019 2018 Leasehold improvements $ 2,335 $ 2,321 Laboratory equipment 3,405 5,510 Furniture and fixtures 744 746 Computer equipment 409 409 Construction in progress 83 17 Total property and equipment 6,976 9,003 Accumulated depreciation and amortization (2,626 ) (2,319 ) Net property and equipment $ 4,350 $ 6,684 Depreciation expense for each of the years ended October 31, 2019 and 2018 was approximately $1.1 million. Disposals of laboratory equipment resulted in losses of approximately $0.3 million and $0.6 million for the years ended October 31, 2019 and 2018, respectively, that was charged to research and development expenses in the statement of operations Management has reviewed its property and equipment for impairment whenever events and circumstances indicate that the carrying value of an asset might not be recoverable. During the years ended October 31, 2019 and 2018, the Company recorded impairment losses on idle laboratory equipment of $0.9 million and $0, respectively, that was charged to research and development expenses in the statement of operations. Fair value for the idle assets was determined by a quoted purchase price for the assets. |
Intangible Assets
Intangible Assets | 12 Months Ended |
Oct. 31, 2019 | |
Goodwill and Intangible Assets Disclosure [Abstract] | |
Intangible Assets | 4. INTANGIBLE ASSETS Intangible assets consist of the following (in thousands): October 31, 2019 2018 Patents $ 5,833 $ 5,970 License 777 777 Software 117 117 Total intangibles 6,727 6,864 Accumulated amortization (2,152 ) (2,026 ) Net intangible assets $ 4,575 $ 4,838 The expirations of the existing patents range from 2019 to 2039 but the expirations can be extended based on market approval if granted and/or based on existing laws and regulations. Capitalized costs associated with patent applications that are abandoned without future value are charged to expense when the determination is made not to pursue the application. Patent applications having a net book value of approximately $1.1 million and $1.0 million were abandoned and were charged to general and administrative expenses in the statement of operations for the years ended October 31, 2019 and 2018, respectively. Intangible asset amortization expense that was charged to general and administrative expense in the statement of operations was approximately $0.4 million for each of the years ended October 31, 2019 and 2018, respectively. Management has reviewed its intangible assets for impairment whenever events and circumstances indicate that the carrying value of an asset might not be recoverable. Net assets are recorded on the balance sheet for patents and licenses related to axalimogene filolisbac (AXAL), ADXS-HOT, ADXS-PSA ADXS-HER2 and other products that are in development or out-licensed. However, if a competitor were to gain FDA approval for a treatment before us or if future clinical trials fail to meet the targeted endpoints, the Company would likely record an impairment related to these assets. In addition, if an application is rejected or fails to be issued, the Company would record an impairment of its estimated book value. Lastly, if the Company is unable to raise enough capital to continue funding our studies and developing its intellectual property, the Company would likely record an impairment to certain of these assets. At October 31, 2019, the estimated amortization expense by fiscal year based on the current carrying value of intangible assets is as follows (in thousands): 2020 $ 366 2021 346 2022 346 2023 346 2024 346 Thereafter 3,171 Total $ 4,575 |
Accrued Expenses
Accrued Expenses | 12 Months Ended |
Oct. 31, 2019 | |
Payables and Accruals [Abstract] | |
Accrued Expenses | 5. ACCRUED EXPENSES: The following table represents the major components of accrued expenses (in thousands): October 31, 2019 2018 Salaries and other compensation $ 158 $ 2,035 Vendors 3,194 3,660 Professional fees 126 490 Total accrued expenses $ 3,478 $ 6,185 |
Common Stock Purchase Warrants
Common Stock Purchase Warrants and Warrant Liability | 12 Months Ended |
Oct. 31, 2019 | |
Common Stock Purchase Warrants And Warrant Liability | |
Common Stock Purchase Warrants and Warrant Liability | 6. COMMON STOCK PURCHASE WARRANTS AND WARRANT LIABILITY Warrants As of October 31, 2019, there were outstanding warrants to purchase 432,142 shares of our common stock with exercise prices ranging from $0 to $281.25 per share. Information on the outstanding warrants is as follows: Exercise Number of Shares Underlying Warrants Expiration Date Summary of Warrants $ - 359,838 July 2024 July 2019 Public Offering $ 281.25 25 N/A Other Warrants $ 0.372 72,279 September 2024 September 2018 Public Offering Grand Total 432,142 As of October 31, 2018, there were outstanding warrants to purchase 944,635 shares of our common stock with exercise prices ranging from $22.50 to $281.25 per share. Information on the outstanding warrants is as follows: Exercise Number of Shares Underlying Warrants Expiration Date Summary of Warrants $ 281.25 25 N/A Other Warrants $ 56.25 166 March 2019 March 2014 Public Offering- Placement Agent $ 22.50 944,444 September 2024 September 2018 Public Offering Grand Total 944,635 A summary of warrant activity was as follows (In thousands, except share and per share data): Shares Weighted Weighted Aggregate Outstanding and exercisable warrants at October 31, 2017 206,160 $ 75.00 .92 $ - Issued 944,444 22.50 Expired (205,969 ) 75.00 Outstanding and exercisable warrants at October 31, 2018 944,635 $ 22.50 5.87 $ - Issued 31,885,500 Exercised * (31,540,962 ) Exchanged (856,865 ) Expired (166 ) Outstanding and exercisable warrants at October 31, 2019 432,142 $ 0.08 4.76 $ 114,069 * Includes the cashless exercise of 17,869,662 warrants that resulted in the issuance of 17,869,662 shares of common stock. At October 31, 2019, the Company had 359,863 of its total 432,142 outstanding warrants classified as equity (equity warrants). At October 31, 2018, the Company had 191 of its total 944,635 outstanding warrants classified as equity warrants. At issuance, equity warrants are recorded at their relative fair values, using the Relative Fair Value Method, in the shareholders equity section of the balance sheet. Shares Issued in Settlement of Liability Warrants On March 14, 2019, the Company entered into private exchange agreements with certain holders of warrants issued in connection with the Company’s September 2018 public offering of common stock and warrants. The warrants being exchanged provided for the purchase of up to an aggregate of 856,865 shares of the Company’s common stock at an exercise price of $22.50, with an expiration date of September 11, 2024. Pursuant to such exchange agreements, the Company issued 856,865 shares of common stock to the investors in exchange for such warrants on a 1:1 basis. The exchange of warrants for common stock caused the down round provision to be triggered for the first time and the exercise price of the warrants that were not exchanged were reduced from $22.50 to $4.50. The warrants were valued at approximately $3.9 million on the March 14, 2019 using the Monte Carlo simulation model. In determining the fair warrant of the warrants issued on March 14, 2019, the Company used the following inputs in its Monte Carlo simulation model: exercise price $22.50, stock price $6.45, expected term 5.50 years, volatility 96.37% and risk free interest rate 2.44%. In connection with the exchange of warrants for common stock, the Company recorded a loss of approximately $1.6 million as the fair value of the shares issued exceeded the fair value of warrants exchanged. Warrant Liability At October 31, 2019, the Company had 72,279 of its total 432,142 outstanding warrants classified as liabilities (liability warrants). As of October 31, 2018, the Company had 944,444 of its total 944,635 outstanding warrants classified as liabilities (liability warrants). These warrants contain a down round feature, except for exempt issuances as defined in the warrant agreement, in which the exercise price would immediately be reduced to match a dilutive issuance of common stock, options, convertible securities and changes in option price or rate of conversion. As of October 31, 2018, the down round feature was not triggered. In April 2019, the down round feature was triggered a second time due to the sale of 2,500,000 common shares (see Note 11) and the exercise price of the warrants were reduced from $4.50 to $3.72. In July 2019, the down round feature was triggered a third time due to the sale of 10,650,000 common shares and 13,656,000 pre-funded warrants (see Note 11) and the exercise price of the warrants were reduced from $3.72 to $0.372. The warrants require liability classification as the warrant agreement requires the Company to maintain an effective registration statement and does not specify any circumstances under which net cash settlement would be permitted or required. As a result, net cash settlement is assumed and liability classification is warranted. For these liability warrants, the Company utilized the Monte Carlo simulation model to calculate the fair value of these warrants at issuance and at each subsequent reporting date. During the year ended October 31, 2018, 944,444 warrants were issued at an exercise price of $22.50 with a term of six years. The warrants were valued at approximately $9.9 million on the September 11, 2018 issuance using the Monte Carlo simulation model. In determining the fair warrant of the warrants issued on September 11, 2018, the Company used the following inputs in its Monte Carlo simulation model: exercise price $12.75, stock price $22.50, expected term 6 years, volatility 99.21% and risk free interest rate 2.91%. At October 31, 2019 and October 31, 2018, the fair value of the warrant liability was approximately $19,000 and $6.5 million, respectively. For the years ended October 31, 2019 and 2018, the Company reported income of approximately $2.6 million and $3.4 million, respectively, due to changes in the fair value of the warrant liability. In measuring the warrant liability, the Company used the following inputs in its Monte Carlo simulation model: October 31, 2019 October 31, 2018 Exercise Price $ 0.37 $ 22.50 Stock Price $ 0.32 $ 8.40 Expected Term 4.87 years 5.87 years Volatility % 100.99 % 97.47 % Risk Free Rate 1.51 % 3.03 % |
Share Based Compensation
Share Based Compensation | 12 Months Ended |
Oct. 31, 2019 | |
Share-based Payment Arrangement [Abstract] | |
Share Based Compensation | 7. SHARE BASED COMPENSATION The following table summarizes share-based compensation expense included in the statement of operations by expense category for the years ended October 31, 2019 and 2018 (in thousands): Year Ended October 31, 2019 2018 Research and development $ 1,036 $ 2,836 General and administrative 966 4,147 Total $ 2,002 $ 6,983 Amendments The Advaxis, Inc. 2015 Incentive Plan (the “2015 Plan”) was originally ratified and approved by the Company’s stockholders on May 27, 2015. Subject to proportionate adjustment in the event of stock splits and similar events, the aggregate number of shares of common stock that may be issued under the 2015 Plan is 240,000 shares, plus a number of additional shares (not to exceed 43,333) underlying awards outstanding as of the effective date of the 2015 Plan under the prior plan that thereafter terminate or expire unexercised, or are cancelled, forfeited or lapse for any reason. At the Annual Meeting of Stockholders of the Company held on March 10, 2016, the stockholders ratified and approved an amendment to the 2015 Plan to increase the aggregate number of shares of common stock authorized for issuance under such plan from 240,000 shares to 306,667 shares. Furthermore, the stockholders approved an amendment to the Company’s Certificate of Incorporation to increase the total number of authorized shares of common stock from 45,000,000 shares of common stock to 65,000,000 shares of common stock. At the Annual Meeting of Stockholders of the Company held on April 5, 2017, the stockholders ratified and approved an amendment to the 2015 Plan to increase the aggregate number of shares of common stock authorized for issuance under such plan from 306,667 shares to 406,667 shares. The amendment also included a provision that provides for pre-defined annual increases in the number of shares available for issuance under the Plan equal to the lesser of: (i) 5% of the total number of shares of common stock outstanding, (ii) 166,667, or (iii) a lesser number determined by the Board of Directors. On January 1, 2018, 137,743 shares, or 5% of the total number of shares of common stock outstanding, were added to the 2015 Plan. At the Annual Meeting of Stockholders of the Company held on March 21, 2018, the stockholders ratified and approved an amendment to the Company’s Certificate of Incorporation to increase the total number of authorized shares of common stock from 65,000,000 shares of common stock to 95,000,000 shares of common stock. On January 1, 2019, 166,667 shares were added to the 2015 Plan. At the Annual Meeting of Stockholders of the Company held on February 21, 2019, the Company’s stockholders voted to approve an amendment to increase the number of authorized shares of common stock from 95,000,000 to 170,000,000 and also voted to approve an amendment to allow the Company to execute a reverse stock split of common stock at the discretion of the Board of Directors. The amendment to increase the number of authorized shares of common stock became effective upon filing of the amendment with the Secretary of State of the State of Delaware on February 28, 2019. Additionally, on March 29, 2019, the Company executed a 1 for 15 reverse stock split. As of October 31, 2019, there were 26,161 shares available for issuance under the 2015 Plan. Restricted Stock Units (RSUs) A summary of the Company’s RSU activity and related information for the year ended October 31, 2019 and 2018 is as follows: Number of Weighted-Average Unvested as of October 31, 2017 90,870 $ 128.10 Granted 27,330 29.55 Vested (53,873 ) 115.65 Cancelled (31,713 ) 123.45 Unvested as of October 31, 2018 32,614 $ 70.41 Vested (12,257 ) 78.41 Cancelled (5,651 ) 112.39 Unvested as of October 31, 2019 14,706 $ 47.62 The fair value of the RSUs as of the respective vesting dates was approximately $51,000 and $1.6 million for the years ended October 31, 2019 and 2018, respectively. As of October 31, 2019, there was approximately $0.3 million of unrecognized compensation cost related to non-vested RSUs, which is expected to be recognized over a remaining weighted average vesting period of approximately 1.20 years. As of October 31, 2019, the aggregate intrinsic value of non-vested RSUs was approximately $5,000. Employee Stock Awards Common stock issued to executives and employees related to vested incentive retention awards, employment inducements, management purchases and employee excellence awards totaled 12,245 shares and 48,874 shares (45,830 shares on a net basis after employee taxes) during the years ended October 31, 2019 and 2018, respectively. Total stock compensation expense associated with these awards for the years ended October 31, 2019 and 2018 was approximately $0.8 million and $3.1 million, respectively. Included in compensation expense for the year ended October 31, 2018 was approximately $0.1 million and $0.3 million, respectively, recognized as a result of the modification of certain RSU’s associated with the resignation of the Company’s Chief Financial Officer in April 2018 and Chief Operating Officer in June 2018. Pursuant to the separation agreements, the vesting was accelerated on all of the outstanding RSU’s. Director Stock Awards During the years ended October 31, 2019 and 2018, common stock issued to the Directors for compensation related to board and committee membership was 0 shares and 5,000 shares, respectively. During the years ended October 31, 2019 and 2018, total stock compensation expense to the Directors was $0 and $0.2 million, respectively. Stock Options A summary of changes in the stock option plan for the years ended October 31, 2019 and 2018 is as follows (in thousands, except share and per share data): Shares Weighted Weighted Aggregate Outstanding as of October 31, 2017 259,571 $ 187.65 5.72 $ - Granted 167,871 30.90 Cancelled or expired (97,371 ) 137.10 Outstanding as of October 31, 2018 330,071 $ 122.79 6.56 $ - Granted 265,882 2.36 Cancelled or expired (35,463 ) 29.52 Outstanding as of October 31, 2019 560,490 $ 71.56 7.34 $ 1 Vested and exercisable at October 31, 2019 240,015 $ 155.25 4.50 $ - The following table summarizes information about the outstanding and exercisable options at October 31, 2019: Options Outstanding Options Exercisable Weighted Weighted Weighted Weighted Average Average Average Average Exercise Number Remaining Exercise Intrinsic Number Remaining Exercise Intrinsic Price Range Outstanding Contractual Price Value Exercisable Contractual Price Value $ .30-$10.00 249,329 9.69 $ 2.35 $ 1 178 8.98 $ 9.00 $ - $ 10.01-$100.00 119,753 8.53 $ 29.70 $ - 52,846 8.17 $ 34.15 $ - $ 100.01-$200.00 101,490 3.97 $ 167.11 $ - 97,073 3.85 $ 169.45 $ - $ 200.01-$318.75 89,918 3.04 $ 211.39 $ - 89,918 3.04 $ 211.39 $ - The fair value of each option granted from the Company’s stock option plans during the years ended October 31, 2019 and 2018 was estimated on the date of grant using the Black-Scholes option-pricing model. Using this model, fair value is calculated based on assumptions with respect to (i) expected volatility of the Company’s common stock price, (ii) the periods of time over which employees and Board Directors are expected to hold their options prior to exercise (expected lives), (iii) expected dividend yield on the Company’s common stock, and (iv) risk-free interest rates, which are based on quoted U.S. Treasury rates for securities with maturities approximating expected lives of the options. The Company used their own historical volatility in determining the volatility to be used. The expected term of the stock option grants was calculated using the “simplified” method in accordance with the SEC Staff Accounting Bulletin 107. The “simplified” method was used since the Company believes its historical data does not provide a reasonable basis upon which to estimate expected term and the Company does not have enough option exercise data from its grants issued to support its own estimate as a result of vesting terms and changes in the stock price. The expected dividend yield is zero as the Company has never paid dividends to common shareholders and does not currently anticipate paying any in the foreseeable future. The following table provides the weighted average fair value of options granted to directors and employees and the related assumptions used in the Black-Scholes model: Year Ended October 31, 2019 October 31, 2018 Weighted average fair value of options granted $ 1.84 $ 1.61 Expected term 5.50-6.51 years 5.35-6.51 years Expected volatility 90.24%-104.99 % 91.14%-100.34 % Expected dividends 0 % 0 % Risk free interest rate 1.35%-3.15 % 1.81%-3.16 % Total compensation cost related to the Company’s outstanding stock options, recognized in the statement of operations for the years ended October 31, 2019 and 2018 was approximately $1.2 million and $3.7 million, respectively. Included in compensation expense for the year ended October 31, 2018 is approximately $77,000 recognized as a result of the modification of certain option agreements associated with two Board members that decided not to run for re-election in March 2018. For the modified options, the vesting was accelerated and the expiration dates were changed to the earlier of the original expiration date or March 21, 2023. During the year ended October 31, 2019, 265,882 options were granted with a total grant date fair value of approximately $0.5 million. During the year ended October 31, 2018, 167,871 options were granted with a total grant date fair value of approximately $4.1 million. As of October 31, 2019, there was approximately $1.3 million of unrecognized compensation cost related to non-vested stock option awards, which is expected to be recognized over a remaining weighted average vesting period of approximately 1.65 years. Employee Stock Purchase Plan The Advaxis, Inc. 2018 Employee Stock Purchase Plan (ESPP) was approved by the Company’s shareholders on March 21, 2018. The 2018 ESPP allows employees to purchase common stock of the Company at a 15% discount to the market price on designated exercise dates. Employees were eligible to participate in the 2018 ESPP beginning May 1, 2018. 1,000,000 shares of the Company’s Common stock are reserved for issuance under the 2018 ESPP. During the year ended October 31, 2019, 7,435 shares were issued under the 2018 ESPP and the Company recorded an expense of approximately $2,000. During the year ended October 31, 2018, 2,611 shares were issued under the 2011 and 2018 ESPPs and the Company recorded an expense of approximately $7,000. As of October 31, 2019, 990,665 shares of Company’s common stock remain available for issuance under the 2018 ESPP. |
Collaboration and Licensing Agr
Collaboration and Licensing Agreements | 12 Months Ended |
Oct. 31, 2019 | |
Business Combinations [Abstract] | |
Collaboration and Licensing Agreements | 8. COLLABORATION AND LICENSING AGREEMENTS OS Therapies LLC On September 4, 2018, the Company granted a license to OS Therapies for the use of ADXS31-164, also known as ADXS-HER2, for evaluation in the treatment of osteosarcoma in humans. Under the terms of the license agreement, OST will be responsible for the conduct and funding of a clinical study evaluating ADXS-HER2 in recurrent, completely resected osteosarcoma. Pursuant to the agreement, the Company is to receive an upfront payment, reimbursement for product supply and other support, clinical, regulatory, and sales-based milestone payments, and royalties on future product sales. Amgen On August 1, 2016, the Company entered into a global agreement (the “Amgen Agreement”) with Amgen for the development and commercialization of the Company’s ADXS-NEO, a then- preclinical investigational immunotherapy, using the Company’s proprietary Listeria monocytogenes attenuated bacterial vector which activates a patient’s immune system to respond against unique mutations, or neoepitopes, contained in and identified from an individual patient’s tumor. Under the terms of the Amgen Agreement, Amgen received an exclusive worldwide license to develop and commercialize ADXS-NEO. Amgen made an upfront payment to Advaxis of $40 million and purchased directly from Advaxis 203,163 shares of the Company’s common stock, at approximately $123.00 per share (representing a purchase at market using a 20 day VWAP methodology) for a total of $25 million. Amgen assisted in funding the clinical development and commercialization of ADXS-NEO and Advaxis retained manufacturing responsibilities. Advaxis and Amgen collaborated through a joint steering committee for the development and commercialization of ADXS-NEO. Advaxis received reimbursements for research and development costs and Advaxis was eligible to receive future contingent payments based on development, regulatory and sales milestone payments of up to $475 million and high single digit to double digit royalty payments based on worldwide sales by Amgen. The Company assessed this arrangement in accordance with ASC 606 and concluded that the contract counterparty, Amgen, is a customer. The Company identified the following material promises under the arrangement: (1) licenses, (2) research and development activities, (3) clinical supplies, (4) regulatory responsibilities and (5) participation on a Joint Steering Committee (JSC). The Company determined that the licenses and research and development activities were not distinct from another, as the licenses had limited value without the performance of the research and development activities. Participation on the JSC to oversee the research and development activities was determined to be quantitatively and qualitatively immaterial and therefore was excluded from performance obligations. The clinical supply and regulatory responsibilities did not represent separate performance obligations based on their dependence on the research and development efforts. Based on this assessment, the Company identified one performance obligation at the outset of the Amgen Agreement, which consists of: (1) licenses, (2) research and development activities, (3) clinical supplies and (4) regulatory responsibilities. Under the Amgen Agreement, in order to evaluate the appropriate transaction price, the Company determined that the upfront amount of $40 million constituted the entirety of the consideration to be included in the transaction price as of the outset of the arrangement, which is allocated to the single performance obligation. The Company concluded that a time-based method was most appropriate to measuring progress toward completion given that the research and development services are satisfied reasonably evenly over the agreement and the Company has a stand-ready obligation to perform over such time. Accordingly, progress toward completion and related revenue recognition is measured using the input method of time elapsed relative to the estimated timeline for Advaxis to submit the Phase 2 package to Amgen, or perform the contractual research and development services, which was the predominant promise in the Company’s combined performance obligation to Amgen. The reimbursement for the research and development costs was variable consideration that was included in the transaction price at the outset, subject to the constraint. The Company estimated the consideration from the reimbursement of the research and development costs using the most-likely amount. When the research and development costs are no longer constrained, they are added to the transaction price for the single, combined performance obligation and recognized over the same recognition period as the rest of the performance obligation’s allocated revenue. The potential milestone and sales-based royalty payments that the Company was eligible to receive were excluded from the transaction price, as all milestone and sales royalty amounts were fully constrained based on the probability of achievement. The Company reevaluated the transaction price at the end of each reporting period and as uncertain events were resolved or other changes in circumstances occurred, and, as necessary, adjusted its estimate of the transaction price. On December 10, 2018, the Company received a written notice of termination from Amgen with respect to the Amgen Agreement. The termination became effective as of February 8, 2019, and the Company regained worldwide rights for the development and commercialization of its ADXS-NEO program. On October 24, 2019, Advaxis announced that it has enrolled its last patient in its ADXS-NEO program in monotherapy and will not enter Part B. The remaining deferred revenue of approximately $18.2 million on December 10, 2018 related to the $40 million non-refundable, up-front payment received from Amgen was accounted for as of the modification date. As of that notification date, the Company adjusted revenue on a cumulative catch-up basis considering the revised measure of progress for the combined performance obligation based on the modified service period up to and through the contract termination date of February 8, 2019. The Company recognized cumulative catch-up revenue of approximately $15.6 million on December 10, 2018. The remaining $2.6 million was recognized over the subsequent 60 days until the performance obligation was satisfied on February 8, 2019. During the years ended October 31, 2019 and 2018, the Company recognized revenue from the Amgen Agreement of approximately $20.6 million and $5.8 million, respectively. During the year ended October 31, 2018, Company recorded reductions in research and development expenses of approximately $5.8 million pertaining to the reimbursement of research and development costs. During the year ended October 31, 2019, the reimbursement of research and development costs of approximately $2.0 million was included in revenue. Merck & Co., Inc. On August 22, 2014, the Company entered into a Clinical Trial Collaboration and Supply Agreement (the “Merck Agreement”) with Merck, pursuant to which the parties collaborated on a Phase 1/2 dose-determination and safety trial. The Phase 1 portion of the trial evaluated the safety of our Lm Each party is responsible for their own internal costs and expenses to support the trial, while the Company was responsible for all third party costs of conducting the trial. Merck was responsible for manufacturing and supplying the Merck Compound. The Company was responsible for manufacturing and supplying the Advaxis Compound. The Company is the sponsor of the trial and holds the IND related to the trial. All data and results generated under the trial (“Collaboration Data”) will be jointly owned by the parties, except that ownership of data and information generated from sample analysis to be performed by each party on its respective compound will be owned by the party conducting such testing. All rights to all inventions and discoveries, which claim or cover the combined use of the Advaxis Compound and the Merck Compound shall belong jointly to the parties. Inventions and discoveries relating solely to the Advaxis Compound, or a live attenuated bacterial vaccine, shall be the exclusive property of Advaxis. Inventions and discoveries relating solely to the Merck Compound, or a PD-1 antagonist, shall be the exclusive property of Merck. During the years ended October 31, 2019 and 2018, the Company incurred approximately $0.9 million and $2.4 million, respectively, in expenses pertaining to the Merck agreement, and such expenses were a component of research and development expenses in the statement of operations. Elanco Animal Health (formerly Aratana Therapeutics) On March 19, 2014, the Company and Aratana entered into a definitive Exclusive License Agreement (the “Aratana Agreement”). Pursuant to the Agreement, Advaxis granted Aratana an exclusive, worldwide, royalty-bearing, license, with the right to sublicense, certain Advaxis proprietary technology that enables Aratana to develop and commercialize animal health products that will be targeted for treatment of osteosarcoma and other cancer indications in animals. Under the terms of the Aratana Agreement, Aratana paid an upfront payment to the Company, of $1 million. As this license has stand-alone value to Aratana (who has the ability to sublicense) and was delivered to Aratana, upon execution of the Aratana Agreement, the Company recorded the $1 million payment as licensing revenue during the year ended October 31, 2014. Aratana will also pay the Company up to an additional $36.5 million based on the achievement of certain milestones with respect to the advancement of products pursuant to the terms of the Aratana Agreement. In addition, Aratana may pay the Company an additional $15 million in cumulative sales milestones pursuant to the terms of the Aratana Agreement. During the year ended October 31, 2018, the USDA’s Center for Veterinary Biologics granted Aratana conditional approval for its canine osteosarcoma vaccine using Advaxis’ technology. During the years ended October 31, 2019 and 2018, Advaxis recognized royalty revenue totaling approximately $8,000 and $3,000, respectively, from Aratana’s sales of the canine osteosarcoma vaccine. On July 16, 2019, Aratana announced their shareholders approved a merger agreement with Elanco Animal Health (“Elanco”) whereby Elanco will be the majority shareholder in Aratana. All of the terms of the Aratana Agreement remain in effect. Global BioPharma Inc. On December 9, 2013, the Company entered into an exclusive licensing agreement for the development and commercialization of axalimogene filolisbac with Global BioPharma, Inc. (GBP), a Taiwanese based biotech company funded by a group of investors led by Taiwan Biotech Co., Ltd (TBC). GBP is planning to conduct a randomized Phase 2, open-label, controlled trial in HPV-associated NSCLC in patients following first-line induction chemotherapy. GBP has obtained Taiwanese regulatory approval for this trial and plans to initiate this trial in late 2019 or early 2020. This trial will be fully funded exclusively by GBP and GBP will be responsible for all clinical development and commercialization costs in the GBP territory and GBP is committed to establishing manufacturing capabilities for its own. Under the terms of the agreement, the Company will exclusively license the rights of axalimogene filolisbac to GBP for the Asia, Africa, and former USSR territory, exclusive of India and certain other countries, for all HPV-associated indications. Advaxis will retain exclusive rights to axalimogene filolisbac for the rest of the world. During each of the years ended October 31, 2019 and 2018, the Company recorded $0.25 million in revenue for the annual license fee renewal. Since Advaxis has no significant obligation to perform after the license transfer and has provided GBP with the right to use its intellectual property, performance is satisfied when the license renews. In addition, GBP paid $2.25 million to the contract research organization that manages the Company’s AIM2CERV clinical trial. On June 27, 2019, Advaxis announced that it is closing the AIM2CERV Phase 3 clinical trial with AXAL in high-risk locally advanced cervical cancer. |
Commitments and Contingencies
Commitments and Contingencies | 12 Months Ended |
Oct. 31, 2019 | |
Commitments and Contingencies Disclosure [Abstract] | |
Commitments and Contingencies | 9. COMMITMENTS AND CONTINGENCIES Legal Proceedings Stendhal On September 19, 2018, Stendhal filed a Demand for Arbitration before the International Centre for Dispute Resolution (Case No. 01-18-0003-5013) relating to the Co-development and Commercialization Agreement with Especificos Stendhal SA de CV (the “Stendhal Agreement”). In the demand, Stendhal alleged that (i) the Company breached the Stendhal Agreement when it made certain statements regarding its AIM2CERV program, (ii) that Stendhal was subsequently entitled to terminate the Agreement for cause, which it did so at the time and (iii) that the Company owes Stendhal damages pursuant to the terms of the Stendhal Agreement. Stendhal is seeking to recover $3 million paid to the Company in 2017 as support payments for the AIM2CERV clinical trial along with approximately $0.3 million in expenses incurred. Stendhal is also seeking fees associated with the arbitration and interest. The Company has answered Stendhal’s Demand for Arbitration and denied that it breached the Stendhal Agreement. The Company also alleges that Stendhal breached its obligations to the Company by, among other things, failing to make support payments that became due in 2018 and that Stendhal therefore owes the Company $3 million. Advaxis is also seeking fees associated with the arbitration and interest. On April 2, 2019, the Arbitrator denied the Company’s early application for summary disposition of Stendhal’s claims. No reasoning was provided. From October 21-23, 2019, an evidentiary hearing for the arbitration was conducted, and on November 23, 2019, the arbitrator requested that the parties submit post-hearing briefs. The deadline for submission is January 15, 2020. Closing arguments may also get scheduled at a later date. At this time, the Company is unable to predict the likelihood of an unfavorable outcome. Corporate Office & Manufacturing Facility Lease The Company leases its corporate office and manufacturing facility under an operating lease expiring in November 2025. Future minimum payments under the Company’s operating leases are as follows (in thousands): Year ended October 31, 2020 $ 1,233 2021 1,318 2022 1,369 2023 1,395 2024 1,419 Thereafter 1,564 Total $ 8,298 Rent expense for each of the years ended October 31, 2019 and 2018 was approximately $1.2 million. |
Income Taxes
Income Taxes | 12 Months Ended |
Oct. 31, 2019 | |
Income Tax Disclosure [Abstract] | |
Income Taxes | 10. INCOME TAXES The income tax provision (benefit) consists of the following (in thousands): October 31, 2019 October 31, 2018 Federal Current $ - $ - Deferred 32,673 22,325 State and Local Current - - Deferred (1,634 ) (5,449 ) Change in valuation allowance (31,039 ) (16,876 ) Income tax provision (benefit) $ - $ - The Company has U.S. federal net operating loss carryovers (“NOLs”) of approximately $68.3 million and $265.8 million at October 31, 2019 and 2018 respectively, available to offset taxable income which expire beginning in 2023. If not used, these NOLs may be subject to limitation under Internal Revenue Code Section 382 should there be a greater than 50% ownership change as determined under the regulations. During the years ended October 31, 2019 and 2018, the Company performed a detailed analysis of any historical and/or current Section 382 ownership changes that may limit the utilization of the net operating loss carryovers. From the entire federal NOL of $278.1 million as of October 31, 2019, approximately $68.3 million is available for use based on Internal Revenue Code Section 382 analysis. The NOL and the deferred tax asset table below does not include approximately $209.8 million of NOL’s that may expire unused. The Company also has New Jersey State Net Operating Loss carryovers of approximately $116.6 million as of October 31, 2019 available to offset future taxable income through 2039. In assessing the realization of deferred tax assets, management considers whether it is more likely than not that some portion or all of the deferred tax assets will not be realized. The ultimate realization of deferred tax assets is dependent upon future generation for taxable income during the periods in which temporary differences representing net future deductible amounts become deductible. Management considers the scheduled reversal of deferred tax liabilities, projected future taxable income and tax planning strategies in making this assessment. After consideration of all the information available, management believes that significant uncertainty exists with respect to future realization of the deferred tax assets and has therefore established a full valuation allowance. On December 22, 2017, the U.S. government enacted comprehensive tax legislation commonly referred to as the Tax Cuts and Jobs Act (the “Tax Act”). The Tax Act made broad and significant changes to the U.S. tax code including, but not limited to, a change in the federal rate from 34% to 21%. As a result of the enactment of the legislation, the Company recorded a one-time reduction to its deferred tax assets of approximately $34.4 million, which was offset by a reduction in the valuation allowance. When a U.S. federal tax rate change occurs during a fiscal year, taxpayers are required to compute a weighted daily average rate for the fiscal year of enactment. As a result of the Tax Act, Advaxis has calculated a blended U.S. federal statutory corporate income tax rate of approximately 23% for the year ended October 31, 2018 and applied this rate in computing the income tax provision for year ending October 31, 2018. The blended U.S. federal statutory corporate income tax rate of 23% is the weighted daily average rate between the pre-enactment U.S. federal statutory tax rate of 34% applicable to the Company’s 2018 fiscal year prior to the Effective Date and the post-enactment U.S. federal statutory tax rate of 21% applicable to the 2018 fiscal year thereafter. Advaxis expects the U.S. federal statutory rate to be 21% for fiscal years beginning after October 31, 2018. The Company evaluated the provisions of ASC 740 related to the accounting for uncertainty in income taxes recognized in an enterprise’s financial statements. ASC 740 prescribes a comprehensive model for how a company should recognize, present, and disclose uncertain positions that the company has taken or expects to take in its tax return. For those benefits to be recognized, a tax position must be more-likely-than-not to be sustained upon examination by taxing authorities. Differences between tax positions taken or expected to be taken in a tax return and the net benefit recognized and measured pursuant to the interpretation are referred to as “unrecognized benefits.” A liability is recognized (or amount of net operating loss carry forward or amount of tax refundable is reduced) for unrecognized tax benefit because it represents an enterprise’s potential future obligation to the taxing authority for a tax position that was not recognized as a result of applying the provisions of ASC 740. If applicable, interest costs related to the unrecognized tax benefits are required to be calculated and would be classified as other expense in the statement of operations. Penalties would be recognized as a component of general and administrative expenses in the statement of operations. No interest or penalties on unpaid tax were recorded during the years ended October 31, 2019 and 2018, respectively. As of October 31, 2019 and 2018, no liability for unrecognized tax benefits was required to be reported. The Company does not expect any significant changes in its unrecognized tax benefits in the next year. The Company files tax returns in the U.S. federal and state jurisdictions and is subject to examination by tax authorities beginning with the year ended October 31, 2016. The Company’s deferred tax assets (liabilities) consisted of the effects of temporary differences attributable to the following (in thousands): Years Ended October 31, 2019 October 31, 2018 Deferred Tax Assets Net operating loss carryovers $ 22,627 $ 65,002 Stock-based compensation 11,767 12,081 Research and development credits 10,234 6,843 Capitalized R&D costs 13,399 - Deferred revenue - 5,247 Other deferred tax assets 405 587 Total deferred tax assets $ 58,432 $ 89,760 Valuation allowance (56,822 ) (87,862 ) Deferred tax asset, net of valuation allowance $ 1,610 $ 1,898 Deferred Tax Liabilities Other deferred tax liabilities $ (1,610 ) $ (1,898 ) Total deferred tax liabilities $ (1,610 ) $ (1,898 ) Net deferred tax asset (liability) $ - $ - The expected tax (expense) benefit based on the statutory rate is reconciled with actual tax expense benefit as follows: Years Ended October 31, 2019 October 31, 2018 US Federal statutory rate 21.00 % 23.17 % State income tax, net of federal benefit 9.84 8.19 Permanent differences 1.23 1.22 Research and development credits 17.30 (0.38 ) Change in valuation allowance (47.02 ) 25.37 Tax Cuts and Jobs Act - (53.93 ) Other (2.34 ) (3.64 ) Income tax (provision) benefit 0.00 % 0.00 % Sale of Net Operating Losses (NOLs) The Company was eligible to receive cash from the sale of its Net Operating Losses under the State of New Jersey NOL Transfer Program. In January 2018, the Company received a net cash amount of approximately $4.5 million from the sale of its state NOLs and research and development tax credits for the year ended October 31, 2016. Following the receipt of the NOL and research and development tax credit for the year ending October 31, 2016, the Company reached the limit under the NJ NOL program. |
Stockholders' Equity
Stockholders' Equity | 12 Months Ended |
Oct. 31, 2019 | |
Equity [Abstract] | |
Stockholders' Equity | 11. STOCKHOLDERS’ EQUITY At-the-Market Transactions During January 2018, the Company sold 58,776 shares of its common stock at-the-market transactions resulting in net proceeds of approximately $2.7 million. Public Offerings During February 2018, the Company closed on an underwritten public offering of 666,667 shares of the Company’s common stock in a public offering at $30.00 per share, for total gross proceeds of $20 million. After deducting the underwriting discounts and commissions and other offering expenses, the net proceeds from the offering were approximately $18.4 million. The sale of the Offered Shares was registered pursuant to a Registration Statement (No. 333-216008) on Form S-3, as amended, which was filed by the Company with the Securities and Exchange Commission on March 17, 2017 and declared effective on March 20, 2017. In September 2018, the Company closed on an underwritten public offering of 1,111,111 shares of its common stock and warrants to purchase up to 944,444 shares of common stock at a public offering price of $18.00, for gross proceeds of $20 million. Each share of common stock was sold together in a fixed combination with a warrant to purchase 0.85 shares of common stock. The warrants are exercisable immediately, expire six years from the date of issuance and have an exercise price of $22.50 per share, subject to anti-dilution adjustments (see Note 6). After deducting the underwriting discounts and commissions and other offering expenses, the net proceeds from the offering were approximately $18.2 million. The shares of common stock were sold pursuant to an effective shelf registration statement on Form S-3 (No. 333- 226988) filed with the Securities and Exchange Commission on August 23, 2018 and declared effective on August 30, 2018. In April 2019, the Company issued 2,500,000 shares of the Company’s common stock in a public offering at $4.00 per share, less underwriting discounts and commissions. The net proceeds to the Company from the transaction was approximately $9 million. In July 2019, the Company closed on an underwritten public offering of 10,650,000 shares of its common stock, pre-funded warrants to purchase 13,656,000 shares of common stock and warrants to purchase up to 17,142,000 shares of common stock for gross proceeds of $17.0 million. Each share of common stock was sold together in a fixed combination with a warrant to purchase 0.75 shares of common stock for $0.70, and each pre-funded warrant was sold together in a fixed combination with a warrant to purchase 0.75 shares of common stock for $0.699. The pre-funded warrants are exercisable immediately, do not expire and have an exercise price of $0.001 per share. The warrants are exercisable immediately, expire five years from the date of issuance, have an exercise price of $2.80 per share and are subject to anti-dilution and other adjustments for certain The warrants also provide that if during the period of time between the date that is the earlier of (i) 30 days after issuance and (ii) if the common stock trades an aggregate of more than 35,000,000 shares after the pricing of the offering, and ending 15 months after issuance, the weighted-average price of common stock immediately prior to the exercise date is lower than the then-applicable exercise price per share, each Common Warrant may be exercised, at the option of the holder, on a cashless basis for one share of Common Stock. After deducting the underwriting discounts and commissions and other offering expenses, the net proceeds from the offering were approximately $15.5 million. |
Fair Value
Fair Value | 12 Months Ended |
Oct. 31, 2019 | |
Fair Value Disclosures [Abstract] | |
Fair Value | 12. FAIR VALUE The authoritative guidance for fair value measurements defines fair value as the exchange price that would be received for an asset or paid to transfer a liability (an exit price) in the principal or the most advantageous market for the asset or liability in an orderly transaction between market participants on the measurement date. Market participants are buyers and sellers in the principal market that are (i) independent, (ii) knowledgeable, (iii) able to transact, and (iv) willing to transact. The guidance describes a fair value hierarchy based on the levels of inputs, of which the first two are considered observable and the last unobservable, that may be used to measure fair value which are the following: ● Level 1 — Quoted prices in active markets for identical assets or liabilities. ● Level 2— Inputs other than Level 1 that are observable, either directly or indirectly, such as quoted prices for similar assets or liabilities; quoted prices in markets that are not active; or other inputs that are observable or corroborated by observable market data or substantially the full term of the assets or liabilities. ● Level 3 — Unobservable inputs that are supported by little or no market activity and that are significant to the value of the assets or liabilities. The following table provides the assets and liabilities carried at fair value measured on a recurring basis as of October 31, 2019 and October 31, 2018: October 31, 2019 Level 1 Level 2 Level 3 Total Common stock warrant liability, warrants exercisable at $0.372 through September 2024 - - $ 19 $ 19 October 31, 2018 Level 1 Level 2 Level 3 Total Common stock warrant liability, warrants exercisable at $22.50 through September 2024 - - $ 6,517 $ 6,517 The following table sets forth a summary of the changes in the fair value of the Company’s warrant liabilities: Year Ended October 31, 2019 2018 Beginning balance $ 6,517 $ - Issuance of warrants - 9,917 Shares issued in settlement of warrants (3,856 ) - Warrant exercises (53 ) - Change in fair value (2,589 ) (3,400 ) Ending Balance $ 19 $ 6,517 |
Employee Benefit Plan
Employee Benefit Plan | 12 Months Ended |
Oct. 31, 2019 | |
Retirement Benefits [Abstract] | |
Employee Benefit Plan | 13. EMPLOYEE BENEFIT PLAN The Company sponsors a 401(k) Plan. Employees become eligible for participation upon the start of employment. Participants may elect to have a portion of their salary deferred and contributed to the 401(k) Plan up to the limit allowed under the Internal Revenue Code. The Company makes a matching contribution to the plan for each participant who has elected to make tax-deferred contributions for the plan year. The Company made matching contributions which amounted to approximately $0.2 million and $0.4 million for the years ended October 31, 2019 and 2018, respectively. These amounts were charged to the statement of operations. The employer contributions vest immediately. |
Summary of Significant Accoun_2
Summary of Significant Accounting Policies and Basis of Presentation (Policies) | 12 Months Ended |
Oct. 31, 2019 | |
Accounting Policies [Abstract] | |
Estimates | Estimates The preparation of financial statements in conformity with accounting principles generally accepted in the United States of America (“U.S. GAAP”) requires management to make estimates and assumptions that affect the amounts reported in the financial statements and accompanying notes. Estimates are used when accounting for such items as the fair value and recoverability of the carrying value of property and equipment and intangible assets (patents and licenses), deferred expenses and deferred revenue, the fair value of options, warrants and related disclosure of contingent assets and liabilities. On an on-going basis, the Company evaluates its estimates, based on historical experience and on various other assumptions that it believes to be reasonable under the circumstances. Actual results may or may not differ from estimates. |
Reclassification | Reclassification Certain amounts in the prior period financial statements have been reclassified to confirm to the presentation of the current period financial statements. The reclassifications had no effect on the previously reported net loss . |
Revenue Recognition | Revenue Recognition Effective November 1, 2018, the Company adopted ASC Topic 606, Revenue form Contracts with Customers (ASC 606), using the modified retrospective transition method. Under this method, results for reporting periods beginning on November 1, 2018 are presented under ASC 606, while prior period amounts are not adjusted and continue to be reported in accordance with ASC Topic 605, Revenue Recognition The Company enters into licensing agreements that are within the scope of ASC 606, under which it may exclusively license rights to research, develop, manufacture and commercialize its product candidates to third parties. The terms of these arrangements typically include payment to the Company of one or more of the following: non-refundable, upfront license fees; reimbursement of certain costs; customer option exercise fees; development, regulatory and commercial milestone payments; and royalties on net sales of licensed products. In determining the appropriate amount of revenue to be recognized as it fulfills its obligations under its agreements, the Company performs the following steps: (i) identification of the promised goods or services in the contract; (ii) determination of whether the promised goods or services are performance obligations including whether they are distinct in the context of the contract; (iii) measurement of the transaction price, including the constraint on variable consideration; (iv) allocation of the transaction price to the performance obligations; and (v) recognition of revenue when (or as) the Company satisfies each performance obligation. As part of the accounting for these arrangements, the Company must use significant judgment to determine: (a) the number of performance obligations based on the determination under step (ii) above; (b) the transaction price under step (iii) above; and (c) the stand-alone selling price for each performance obligation identified in the contract for the allocation of transaction price in step (iv) above. The Company uses judgment to determine whether milestones or other variable consideration, except for royalties, should be included in the transaction price as described further below. The transaction price is allocated to each performance obligation on a relative stand-alone selling price basis, for which the Company recognizes revenue as or when the performance obligations under the contract are satisfied. Amounts received prior to revenue recognition are recorded as deferred revenue. Amounts expected to be recognized as revenue within the 12 months following the balance sheet date are classified as current portion of deferred revenue in the accompanying balance sheets. Amounts not expected to be recognized as revenue within the 12 months following the balance sheet date are classified as deferred revenue, net of current portion. Exclusive Licenses. Research and Development Services. Milestone Payments. Royalties. |
Collaborative Arrangements | Collaborative Arrangements The Company analyzes its collaboration arrangements to assess whether such arrangements involve joint operating activities performed by parties that are both active participants in the activities and exposed to significant risks and rewards dependent on the commercial success of such activities and therefore within the scope of ASC Topic 808, Collaborative Arrangements |
Cash and Cash Equivalents | Cash and Cash Equivalents The Company considers all highly liquid investments with an original maturity of three months or less from the date of purchase to be cash equivalents. |
Concentration of Credit Risk | Concentration of Credit Risk The Company maintains its cash in bank deposit accounts (checking) that at times exceed federally insured limits. Approximately $30.9 million is subject to credit risk at October 31, 2019. However, these cash balances are maintained at creditworthy financial institutions. The Company has not experienced any losses in such accounts and believes it is not exposed to any significant credit risk. |
Restricted Cash and Letter of Credit | Restricted Cash and Letter of Credit During July 2017 and January 2018, the Company established two letters of credit with a financial institution as security for the purchase of custom equipment and as security for application fees associated with the Company’s Marketing Authorization Application (“MAA”) in Europe. The letters of credit were collateralized by cash which was unavailable for withdrawal or for usage for general obligations. During the year ended October 31, 2019, the two letters of credit were terminated and as of October 31, 2019 the Company has no restricted cash balance. |
Deferred Expenses | Deferred Expenses Deferred expenses consist of advanced payments made on research and development projects. Expense is recognized in the Statement of Operations as the research and development activity is performed. |
Property and Equipment | Property and Equipment Property and equipment is stated at cost. Additions and improvements that extend the lives of the assets are capitalized, while expenditures for repairs and maintenance are expensed as incurred. Leasehold improvements are amortized on a straight-line basis over the shorter of the asset’s estimated useful life or the remaining lease term. Depreciation is calculated on a straight-line basis over the estimated useful lives of the assets ranging from three to ten years. When depreciable assets are retired or sold the cost and related accumulated depreciation are removed from the accounts and any resulting gain or loss is recognized in operations. |
Intangible Assets | Intangible Assets Intangible assets are recorded at cost and include patents and patent application costs, licenses and software. Intangible assets are amortized on a straight-line basis over their estimated useful lives ranging from 3 to 20 years. Patent application costs are written-off if the application is rejected, withdrawn or abandoned. |
Impairment of Long-Lived Assets | Impairment of Long-Lived Assets The Company reviews its long-lived assets, including property and equipment and intangible assets, for impairment whenever events and circumstances indicate that the carrying value of an asset might not be recoverable. Recoverability of assets held and used is measured by comparison of the carrying amount of an asset to the future undiscounted cash flows expected to be generated from the use of the asset and its eventual disposition. If the total of the undiscounted future cash flows is less than the carrying amount of those assets, an impairment loss is recognized in the Statement of Operations based on the excess of the carrying amount over the fair value of the asset. |
Net Income (Loss) Per Share | Net Income (Loss) per Share Basic net income or loss per common share is computed by dividing net income or loss available to common shareholders by the weighted average number of common shares outstanding during the period. Diluted earnings per share give effect to dilutive options, warrants, convertible debt and other potential common stock outstanding during the period. In the case of a net loss the impact of the potential common stock resulting from warrants, outstanding stock options and convertible debt are not included in the computation of diluted loss per share, as the effect would be anti-dilutive. In the case of net income, the impact of the potential common stock resulting from these instruments that have intrinsic value are included in the diluted earnings per share. The table sets forth the number of potential shares of common stock that have been excluded from diluted net loss per share. As of October 31, 2019 2018 Warrants 432,142 944,635 Stock options 560,490 330,071 Restricted stock units 14,706 32,614 Total 1,007,338 1,307,320 |
Research and Development Expenses | Research and Development Expenses Research and development costs are expensed as incurred and include but are not limited to clinical trial and related manufacturing costs, payroll and personnel expenses, lab expenses, and related overhead costs. |
Stock Based Compensation | Stock Based Compensation The Company has an equity plan which allows for the granting of stock options to its employees, directors and consultants for a fixed number of shares with an exercise price equal to the fair value of the shares at date of grant. The Company measures the cost of services received in exchange for an award of equity instruments based on the fair value of the award. The fair value of the award is measured on the grant date and is then recognized over the requisite service period, usually the vesting period, in both research and development expenses and general and administrative expenses on the statement of operations, depending on the nature of the services provided by the employees or consultants. The process of estimating the fair value of stock-based compensation awards and recognizing stock-based compensation cost over their requisite service period involves significant assumptions and judgments. The Company estimates the fair value of stock option awards on the date of grant using the Black Scholes Model (“BSM”) for the remaining awards, which requires that the Company makes certain assumptions regarding: (i) the expected volatility in the market price of its common stock; (ii) dividend yield; (iii) risk-free interest rates; and (iv) the period of time employees are expected to hold the award prior to exercise (referred to as the expected holding period). As a result, if the Company revises its assumptions and estimates, stock-based compensation expense could change materially for future grants. The Company accounts for stock-based compensation using fair value recognition and records forfeitures as they occur. As such, the Company recognizes stock-based compensation cost only for those stock-based awards that vest over their requisite service period, based on the vesting provisions of the individual grants. |
Fair Value of Financial Instruments | Fair Value of Financial Instruments The carrying value of financial instruments, including cash and cash equivalents, restricted cash and accounts payable approximated fair value as of the balance sheet date presented, due to their short maturities. |
Derivative Financial Instruments | Derivative Financial Instruments The Company does not use derivative instruments to hedge exposures to cash flow, market or foreign currency risks. The Company evaluates all of its financial instruments to determine if such instruments are derivatives or contain features that qualify as embedded derivatives. For derivative financial instruments that are accounted for as liabilities, the derivative instrument is initially recorded at its fair value and is then re-valued at each reporting date, with changes in the fair value reported in the statements of operations. For stock-based derivative financial instruments, the Company used the Monte Carlo simulation model to value the derivative instruments at inception and on subsequent valuation dates. The classification of derivative instruments, including whether such instruments should be recorded as liabilities or as equity, is evaluated at the end of each reporting period. Derivative liabilities are classified in the balance sheet as current or non-current based on whether or not net-cash settlement of the instrument could be required within 12 months of the balance sheet date. |
Income Taxes | Income Taxes The Company uses the asset and liability method of accounting for income taxes in accordance with ASC Topic 740, “Income Taxes.” Under this method, income tax expense is recognized for the amount of: (i) taxes payable or refundable for the current year and (ii) deferred tax consequences of temporary differences resulting from matters that have been recognized in an entity’s financial statements or tax returns. Deferred tax assets and liabilities are measured using enacted tax rates expected to apply to taxable income in the years in which those temporary differences are expected to be recovered or settled. The effect on deferred tax assets and liabilities of a change in tax rates is recognized in the results of operations in the period that includes the enactment date. A valuation allowance is provided to reduce the deferred tax assets reported if based on the weight of the available positive and negative evidence, it is more likely than not some portion or all of the deferred tax assets will not be realized. |
Recent Accounting Standards | Recent Accounting Standards In February 2016, the Financial Accounting Standards Board, (“FASB”), issued Accounting Standards Update, (“ASU”), No. 2016-02, Leases (Topic 842), which establishes a comprehensive new lease accounting model. The new standard: (a) clarifies the definition of a lease; (b) requires a dual approach to lease classification similar to current lease classifications; and (c) causes lessees to recognize leases on the balance sheet as a lease liability with a corresponding right-of-use asset for leases with a lease-term of more than 12 months. The new standard is effective for fiscal years and interim periods beginning after December 15, 2018, with early adoption permitted. A modified retrospective transition approach is required for leases existing at, or entered into after, the beginning of the earliest comparative period presented in the financial statements, including a number of optional practical expedients that entities may elect to apply. In July 2018, the FASB issued ASU No. 2018-11, Leases (Topic 842): Targeted Improvements, an update which provides another transition method, in addition to the existing modified retrospective transition method, by allowing entities to initially apply the new lease standard at the adoption date and recognize a cumulative-effect adjustment to the opening balance of retained earnings in the period of adoption. The Company adopted Topic 842 effective November 1, 2019 using a modified retrospective method and will not restate comparative periods. Upon adoption, the Company recorded a right-to-use asset of approximately $5.3 million and a corresponding lease liability of approximately $6.6 million on the Company’s balance sheet with the difference relating to reclassifications of the deferred rent liability and lease incentive obligation as reductions to the right-of-use asset for its operating lease. Adoption of the new lease standard will not have a significant impact on the Company’s statement of operations. |
Recently Adopted Accounting Standards | Recently Adopted Accounting Standards In May 2014, FASB issued ASU No. 2014-09, which amends the guidance for accounting for revenue from contracts with customers. ASU No. 2014-09 superseded the revenue recognition requirements in ASC 605 and created ASC 606 described above. In 2015 and 2016, the FASB issued additional ASUs related to ASC 606 that delayed the effective date of the guidance and clarified various aspects of the new revenue guidance, including principal versus agent considerations, identifying performance obligations, and licensing, and they include other improvements and practical expedients. Effective November 1, 2018, the Company adopted ASC 606 using the modified retrospective transition method. As a result of adopting ASC 606, the Company made reclassifications to the balance sheet and income statement. Net income (loss) was not impacted by the adoption of ASC 606. A summary of the amount by which each financial statement line item was affected by the impact of the cumulative adjustment is set forth in the table below (in thousands): Impact of ASC 606 Adoption on (in thousands) As reported Adjustments Balances without adoption of ASC 606 Accounts receivable $ 1,664 $ 1,664 $ - Prepaid expenses and other current assets $ 1,611 $ (1,664 ) $ 3,275 A summary of the amount by which each financial statement line item was affected in the current reporting period by ASC 606 as compared with the guidance that was in effect prior to the adoption of ASC 606 is set forth in the tables below. Impact of ASC 606 Adoption on (in thousands) As reported Adjustments Balances without adoption of ASC 606 Accounts receivable $ - $ - $ - Prepaid expenses and other current assets $ 1,433 $ - $ 1,433 Impact of ASC 606 Adoption on (in thousands) As reported under ASC 606 Adjustments Balances without adoption of ASC 606 Revenue $ 20,884 $ 1,960 $ 18,924 Research and Development Expenses $ 30,320 $ 1,960 $ 28,360 Impact of ASC 606 Adoption on (in thousands) As reported under ASC 606 Adjustments Balances without adoption of ASC 606 Accounts receivable $ - $ - $ - Prepaid expenses and other current assets $ 1,433 - 1,433 The most significant change to the Company’s accounting for revenue as a result of the adoption of ASC 606 relates to its treatment of clinical development payments it receives in its collaboration and licensing agreement with Amgen, Inc. (“Amgen”). Under ASC 605, the Company accounted for the clinical development payments as a reduction of research and development expenses in the statement of operations. Under ASC 606, the Company accounted for the reimbursements for research and development costs as revenue. For further discussion of the adoption of this standard, see Note 8. In November 2018, the FASB issued ASU No. 2018-18, “Collaborative Arrangements (Topic 808)—Clarifying the Interaction between Topic 808 and Topic 606” (“ASU 2018-18”). The amendments in ASU 2018-18 make targeted improvements to generally accepted accounting principles (GAAP) for collaborative arrangements by clarifying that certain transactions between collaborative arrangement participants should be accounted for as revenue under Topic 606 when the collaborative arrangement participant is a customer in the context of a unit of account. In those situations, all the guidance in Topic 606 should be applied, including recognition, measurement, presentation, and disclosure requirements. In addition, unit-of-account guidance in Topic 808 was aligned with the guidance in Topic 606 (that is, a distinct good or service) when an entity is assessing whether the collaborative arrangement or a part of the arrangement is within the scope of Topic 606. ASU 2018-18 is effective for fiscal years beginning after December 15, 2019, and interim periods within those fiscal years. Early adoption is permitted, including adoption in any interim period. The amendments should be applied retrospectively to the date of initial application of Topic 606. The Company adopted this guidance effective November 1, 2018 using the modified retrospective approach. There was no impact on the Company’s financial statements. In June 2018, the FASB issued ASU No. 2018-07, “Compensation—Stock Compensation (Topic 718) —Improvements to Nonemployee Share-Based Payment Accounting” (“ASU 2018-07”). The amendments in ASU 2018-07 expand the scope of Topic 718 to include share-based payment transactions for acquiring goods and services from nonemployees. An entity should apply the requirements of Topic 718 to nonemployee awards except for specific guidance on inputs to an option pricing model and the attribution of cost (that is, the period of time over which share-based payment awards vest and the pattern of cost recognition over that period). The amendments specify that Topic 718 applies to all share-based payment transactions in which a grantor acquires goods or services to be used or consumed in a grantor’s own operations by issuing share-based payment awards. The amendments also clarify that Topic 718 does not apply to share-based payments used to effectively provide (1) financing to the issuer or (2) awards granted in conjunction with selling goods or services to customers as part of a contract accounted for under Topic 606, Revenue from Contracts with Customers. ASU 2018-07 is effective for public business entities for fiscal years beginning after December 15, 2018, including interim periods within that fiscal year. Early adoption is permitted, but no earlier than an entity’s adoption date of Topic 606. The Company adopted this guidance effective as of February 1, 2019. There was no impact on the Company’s financial statements. In November 2016, the FASB issued ASU No. 2016-18, Restricted Cash Management does not believe that any other recently issued, but not yet effective accounting pronouncements, if adopted, would have a material impact on the accompanying financial statements. |
Summary of Significant Accoun_3
Summary of Significant Accounting Policies and Basis of Presentation (Tables) | 12 Months Ended |
Oct. 31, 2019 | |
Accounting Policies [Abstract] | |
Schedule of Anti-dilutive Securities Excluded from Diluted Net Loss Per Share | The table sets forth the number of potential shares of common stock that have been excluded from diluted net loss per share. As of October 31, 2019 2018 Warrants 432,142 944,635 Stock options 560,490 330,071 Restricted stock units 14,706 32,614 Total 1,007,338 1,307,320 |
Schedule of Reclassifications to Balance Sheet and Income Statement | A summary of the amount by which each financial statement line item was affected by the impact of the cumulative adjustment is set forth in the table below (in thousands): Impact of ASC 606 Adoption on (in thousands) As reported Adjustments Balances without adoption of ASC 606 Accounts receivable $ 1,664 $ 1,664 $ - Prepaid expenses and other current assets $ 1,611 $ (1,664 ) $ 3,275 A summary of the amount by which each financial statement line item was affected in the current reporting period by ASC 606 as compared with the guidance that was in effect prior to the adoption of ASC 606 is set forth in the tables below. Impact of ASC 606 Adoption on (in thousands) As reported Adjustments Balances without adoption of ASC 606 Accounts receivable $ - $ - $ - Prepaid expenses and other current assets $ 1,433 $ - $ 1,433 Impact of ASC 606 Adoption on (in thousands) As reported under ASC 606 Adjustments Balances without adoption of ASC 606 Revenue $ 20,884 $ 1,960 $ 18,924 Research and Development Expenses $ 30,320 $ 1,960 $ 28,360 Impact of ASC 606 Adoption on (in thousands) As reported under ASC 606 Adjustments Balances without adoption of ASC 606 Accounts receivable $ - $ - $ - Prepaid expenses and other current assets $ 1,433 - 1,433 |
Property and Equipment (Tables)
Property and Equipment (Tables) | 12 Months Ended |
Oct. 31, 2019 | |
Property, Plant and Equipment [Abstract] | |
Schedule of Property and Equipment | Property and equipment consists of the following (in thousands): October 31, 2019 2018 Leasehold improvements $ 2,335 $ 2,321 Laboratory equipment 3,405 5,510 Furniture and fixtures 744 746 Computer equipment 409 409 Construction in progress 83 17 Total property and equipment 6,976 9,003 Accumulated depreciation and amortization (2,626 ) (2,319 ) Net property and equipment $ 4,350 $ 6,684 |
Intangible Assets (Tables)
Intangible Assets (Tables) | 12 Months Ended |
Oct. 31, 2019 | |
Goodwill and Intangible Assets Disclosure [Abstract] | |
Summary of Intangible Assets | Intangible assets consist of the following (in thousands): October 31, 2019 2018 Patents $ 5,833 $ 5,970 License 777 777 Software 117 117 Total intangibles 6,727 6,864 Accumulated amortization (2,152 ) (2,026 ) Net intangible assets $ 4,575 $ 4,838 |
Schedule of Carrying Value of Intangible Assets | At October 31, 2019, the estimated amortization expense by fiscal year based on the current carrying value of intangible assets is as follows (in thousands): 2020 $ 366 2021 346 2022 346 2023 346 2024 346 Thereafter 3,171 Total $ 4,575 |
Accrued Expenses (Tables)
Accrued Expenses (Tables) | 12 Months Ended |
Oct. 31, 2019 | |
Payables and Accruals [Abstract] | |
Schedule of Accrued Expenses | The following table represents the major components of accrued expenses (in thousands): October 31, 2019 2018 Salaries and other compensation $ 158 $ 2,035 Vendors 3,194 3,660 Professional fees 126 490 Total accrued expenses $ 3,478 $ 6,185 |
Common Stock Purchase Warrant_2
Common Stock Purchase Warrants and Warrant Liability (Tables) | 12 Months Ended |
Oct. 31, 2019 | |
Common Stock Purchase Warrants And Warrant Liability | |
Schedule of Outstanding Warrants | Exercise Number of Shares Underlying Warrants Expiration Date Summary of Warrants $ - 359,838 July 2024 July 2019 Public Offering $ 281.25 25 N/A Other Warrants $ 0.372 72,279 September 2024 September 2018 Public Offering Grand Total 432,142 Exercise Number of Shares Underlying Warrants Expiration Date Summary of Warrants $ 281.25 25 N/A Other Warrants $ 56.25 166 March 2019 March 2014 Public Offering- Placement Agent $ 22.50 944,444 September 2024 September 2018 Public Offering Grand Total 944,635 |
Schedule of Warrants Activity | A summary of warrant activity was as follows (In thousands, except share and per share data): Shares Weighted Weighted Aggregate Outstanding and exercisable warrants at October 31, 2017 206,160 $ 75.00 .92 $ - Issued 944,444 22.50 Expired (205,969 ) 75.00 Outstanding and exercisable warrants at October 31, 2018 944,635 $ 22.50 5.87 $ - Issued 31,885,500 Exercised * (31,540,962 ) Exchanged (856,865 ) Expired (166 ) Outstanding and exercisable warrants at October 31, 2019 432,142 $ 0.08 4.76 $ 114,069 * Includes the cashless exercise of 17,869,662 warrants that resulted in the issuance of 17,869,662 shares of common stock. |
Schedule of Assumptions Used in Warrant Liability | In measuring the warrant liability, the Company used the following inputs in its Monte Carlo simulation model: October 31, 2019 October 31, 2018 Exercise Price $ 0.37 $ 22.50 Stock Price $ 0.32 $ 8.40 Expected Term 4.87 years 5.87 years Volatility % 100.99 % 97.47 % Risk Free Rate 1.51 % 3.03 % |
Share Based Compensation (Table
Share Based Compensation (Tables) | 12 Months Ended |
Oct. 31, 2019 | |
Share-based Payment Arrangement [Abstract] | |
Summary of Share Based Compensation Expense | The following table summarizes share-based compensation expense included in the statement of operations by expense category for the years ended October 31, 2019 and 2018 (in thousands): Year Ended October 31, 2019 2018 Research and development $ 1,036 $ 2,836 General and administrative 966 4,147 Total $ 2,002 $ 6,983 |
Summary of RSU Activity and Related Information | A summary of the Company’s RSU activity and related information for the year ended October 31, 2019 and 2018 is as follows: Number of Weighted-Average Unvested as of October 31, 2017 90,870 $ 128.10 Granted 27,330 29.55 Vested (53,873 ) 115.65 Cancelled (31,713 ) 123.45 Unvested as of October 31, 2018 32,614 $ 70.41 Vested (12,257 ) 78.41 Cancelled (5,651 ) 112.39 Unvested as of October 31, 2019 14,706 $ 47.62 |
Summary of Changes in Stock Option Plan | A summary of changes in the stock option plan for the years ended October 31, 2019 and 2018 is as follows (in thousands, except share and per share data): Shares Weighted Weighted Aggregate Outstanding as of October 31, 2017 259,571 $ 187.65 5.72 $ - Granted 167,871 30.90 Cancelled or expired (97,371 ) 137.10 Outstanding as of October 31, 2018 330,071 $ 122.79 6.56 $ - Granted 265,882 2.36 Cancelled or expired (35,463 ) 29.52 Outstanding as of October 31, 2019 560,490 $ 71.56 7.34 $ 1 Vested and exercisable at October 31, 2019 240,015 $ 155.25 4.50 $ - |
Summary of Outstanding and Exercisable Options | The following table summarizes information about the outstanding and exercisable options at October 31, 2019: Options Outstanding Options Exercisable Weighted Weighted Weighted Weighted Average Average Average Average Exercise Number Remaining Exercise Intrinsic Number Remaining Exercise Intrinsic Price Range Outstanding Contractual Price Value Exercisable Contractual Price Value $ .30-$10.00 249,329 9.69 $ 2.35 $ 1 178 8.98 $ 9.00 $ - $ 10.01-$100.00 119,753 8.53 $ 29.70 $ - 52,846 8.17 $ 34.15 $ - $ 100.01-$200.00 101,490 3.97 $ 167.11 $ - 97,073 3.85 $ 169.45 $ - $ 200.01-$318.75 89,918 3.04 $ 211.39 $ - 89,918 3.04 $ 211.39 $ - |
Summary of Fair Value of Stock Options Granted of BSM | The following table provides the weighted average fair value of options granted to directors and employees and the related assumptions used in the Black-Scholes model: Year Ended October 31, 2019 October 31, 2018 Weighted average fair value of options granted $ 1.84 $ 1.61 Expected term 5.50-6.51 years 5.35-6.51 years Expected volatility 90.24%-104.99 % 91.14%-100.34 % Expected dividends 0 % 0 % Risk free interest rate 1.35%-3.15 % 1.81%-3.16 % |
Commitments and Contingencies (
Commitments and Contingencies (Tables) | 12 Months Ended |
Oct. 31, 2019 | |
Commitments and Contingencies Disclosure [Abstract] | |
Summary of Future Minimum Payments of Operating Leases | Future minimum payments under the Company’s operating leases are as follows (in thousands): Year ended October 31, 2020 $ 1,233 2021 1,318 2022 1,369 2023 1,395 2024 1,419 Thereafter 1,564 Total $ 8,298 |
Income Taxes (Tables)
Income Taxes (Tables) | 12 Months Ended |
Oct. 31, 2019 | |
Income Tax Disclosure [Abstract] | |
Schedule of Income Tax Provision (Benefit) | The income tax provision (benefit) consists of the following (in thousands): October 31, 2019 October 31, 2018 Federal Current $ - $ - Deferred 32,673 22,325 State and Local Current - - Deferred (1,634 ) (5,449 ) Change in valuation allowance (31,039 ) (16,876 ) Income tax provision (benefit) $ - $ - |
Schedule of Deferred Tax Assets (Liabilities) | The Company’s deferred tax assets (liabilities) consisted of the effects of temporary differences attributable to the following (in thousands): Years Ended October 31, 2019 October 31, 2018 Deferred Tax Assets Net operating loss carryovers $ 22,627 $ 65,002 Stock-based compensation 11,767 12,081 Research and development credits 10,234 6,843 Capitalized R&D costs 13,399 - Deferred revenue - 5,247 Other deferred tax assets 405 587 Total deferred tax assets $ 58,432 $ 89,760 Valuation allowance (56,822 ) (87,862 ) Deferred tax asset, net of valuation allowance $ 1,610 $ 1,898 Deferred Tax Liabilities Other deferred tax liabilities $ (1,610 ) $ (1,898 ) Total deferred tax liabilities $ (1,610 ) $ (1,898 ) Net deferred tax asset (liability) $ - $ - |
Schedule of Expected Tax (Expense) Benefit Based on Statutory Rate with Actual Tax Expense Benefit | The expected tax (expense) benefit based on the statutory rate is reconciled with actual tax expense benefit as follows: Years Ended October 31, 2019 October 31, 2018 US Federal statutory rate 21.00 % 23.17 % State income tax, net of federal benefit 9.84 8.19 Permanent differences 1.23 1.22 Research and development credits 17.30 (0.38 ) Change in valuation allowance (47.02 ) 25.37 Tax Cuts and Jobs Act - (53.93 ) Other (2.34 ) (3.64 ) Income tax (provision) benefit 0.00 % 0.00 % |
Fair Value (Tables)
Fair Value (Tables) | 12 Months Ended |
Oct. 31, 2019 | |
Fair Value Disclosures [Abstract] | |
Schedule of Fair Value, Assets and Liabilities Measured on Recurring Basis | The following table provides the assets and liabilities carried at fair value measured on a recurring basis as of October 31, 2019 and October 31, 2018: October 31, 2019 Level 1 Level 2 Level 3 Total Common stock warrant liability, warrants exercisable at $0.372 through September 2024 - - $ 19 $ 19 October 31, 2018 Level 1 Level 2 Level 3 Total Common stock warrant liability, warrants exercisable at $22.50 through September 2024 - - $ 6,517 $ 6,517 |
Schedule of Changes in Fair Value of Warrant Liabilities | The following table sets forth a summary of the changes in the fair value of the Company’s warrant liabilities: Year Ended October 31, 2019 2018 Beginning balance $ 6,517 $ - Issuance of warrants - 9,917 Shares issued in settlement of warrants (3,856 ) - Warrant exercises (53 ) - Change in fair value (2,589 ) (3,400 ) Ending Balance $ 19 $ 6,517 |
Nature of Operations and Basi_2
Nature of Operations and Basis of Presentation (Details Narrative) - USD ($) $ in Thousands | 12 Months Ended | 72 Months Ended | |
Oct. 31, 2019 | Oct. 31, 2018 | Oct. 31, 2019 | |
Proceeds from public offering | $ 27,000 | $ 292,200 | |
Cash and cash equivalents | 32,363 | $ 44,141 | $ 32,363 |
Operating expenses | 38,856 | $ 76,442 | |
Fiscal Year 2020 [Member] | |||
Operating expenses | 29,000 | ||
Non-recurring costs | $ 6,000 |
Summary of Significant Accoun_4
Summary of Significant Accounting Policies and Basis of Presentation (Details Narrative) - USD ($) $ in Thousands | 12 Months Ended | |
Oct. 31, 2019 | Oct. 31, 2018 | |
Concentration at credir risk | $ 30,900 | |
Restricted cash balance | $ 977 | |
Right to use asset | 5,300 | |
Lease liability | $ 6,600 | |
Minimum [Member] | ||
Estimated useful lives of property and equipment | 3 years | |
Estimated useful life of intangible assets | 3 years | |
Maximum [Member] | ||
Estimated useful lives of property and equipment | 10 years | |
Estimated useful life of intangible assets | 20 years |
Summary of Significant Accoun_5
Summary of Significant Accounting Policies and Basis of Presentation - Schedule of Anti-dilutive Securities Excluded from Diluted Net Loss Per Share (Details) - shares | 12 Months Ended | |
Oct. 31, 2019 | Oct. 31, 2018 | |
Antidilutive Securities Excluded from Computation of Earnings Per Share [Line Items] | ||
Anti dilutive securities, share | 1,007,338 | 1,307,320 |
Warrants [Member] | ||
Antidilutive Securities Excluded from Computation of Earnings Per Share [Line Items] | ||
Anti dilutive securities, share | 432,142 | 944,635 |
Stock Options [Member] | ||
Antidilutive Securities Excluded from Computation of Earnings Per Share [Line Items] | ||
Anti dilutive securities, share | 560,490 | 330,071 |
Restricted Stock Units (RSUs) [Member] | ||
Antidilutive Securities Excluded from Computation of Earnings Per Share [Line Items] | ||
Anti dilutive securities, share | 14,706 | 32,614 |
Summary of Significant Accoun_6
Summary of Significant Accounting Policies and Basis of Presentation - Schedule of Reclassifications to Balance Sheet and Income Statement (Details) - USD ($) $ in Thousands | 12 Months Ended | ||
Oct. 31, 2019 | Oct. 31, 2018 | Nov. 02, 2018 | |
Accounts receivable | $ 1,664 | $ 1,664 | |
Prepaid expenses and other current assets | 1,433 | 1,611 | 1,611 |
Revenue | 20,884 | 6,063 | |
Research and Development Expenses | 26,677 | 56,970 | |
Accounts receivable | 1,664 | (153) | |
Prepaid expenses and other current assets | (103) | $ 836 | |
Adjustments [Member] | |||
Accounts receivable | 1,664 | ||
Prepaid expenses and other current assets | (1,664) | ||
Revenue | 1,960 | ||
Research and Development Expenses | 1,960 | ||
Accounts receivable | |||
Prepaid expenses and other current assets | |||
Balances Without Adoption of ASC 606 [Member] | |||
Accounts receivable | |||
Prepaid expenses and other current assets | 1,433 | $ 3,275 | |
Revenue | 18,924 | ||
Research and Development Expenses | 28,360 | ||
Accounts receivable | |||
Prepaid expenses and other current assets | $ 1,433 |
Property and Equipment (Details
Property and Equipment (Details Narrative) - USD ($) $ in Thousands | 12 Months Ended | |
Oct. 31, 2019 | Oct. 31, 2018 | |
Property, Plant and Equipment [Abstract] | ||
Depreciation expense | $ 1,097 | $ 1,113 |
Laboratory equipment, disposed | 300 | 600 |
Impairment loss on idle laboratory equipment | $ 900 | $ 0 |
Property and Equipment - Schedu
Property and Equipment - Schedule of Property and Equipment (Details) - USD ($) $ in Thousands | Oct. 31, 2019 | Oct. 31, 2018 |
Property, Plant and Equipment [Abstract] | ||
Leasehold improvements | $ 2,335 | $ 2,321 |
Laboratory equipment | 3,405 | 5,510 |
Furniture and fixtures | 744 | 746 |
Computer equipment | 409 | 409 |
Construction in progress | 83 | 17 |
Total property and equipment | 6,976 | 9,003 |
Accumulated depreciation and amortization | (2,626) | (2,319) |
Net property and equipment | $ 4,350 | $ 6,684 |
Intangible Assets (Details Narr
Intangible Assets (Details Narrative) - USD ($) $ in Thousands | 12 Months Ended | |
Oct. 31, 2019 | Oct. 31, 2018 | |
Goodwill and Intangible Assets Disclosure [Abstract] | ||
Finite lived patents expirations year | The expirations of the existing patents range from 2019 to 2039 | |
Book value patent applications, net | $ 1,104 | $ 1,047 |
Intangible asset amortization expense | $ 386 | $ 388 |
Intangible Assets - Summary of
Intangible Assets - Summary of Intangible Assets (Details) - USD ($) $ in Thousands | Oct. 31, 2019 | Oct. 31, 2018 |
Goodwill and Intangible Assets Disclosure [Abstract] | ||
Patents | $ 5,833 | $ 5,970 |
License | 777 | 777 |
Software | 117 | 117 |
Total intangibles | 6,727 | 6,864 |
Accumulated amortization | (2,152) | (2,026) |
Net Intangible assets | $ 4,575 | $ 4,838 |
Intangible Assets - Schedule of
Intangible Assets - Schedule of Carrying Value of Intangible Assets (Details) $ in Thousands | Oct. 31, 2019USD ($) |
Goodwill and Intangible Assets Disclosure [Abstract] | |
2020 | $ 366 |
2021 | 346 |
2022 | 346 |
2023 | 346 |
2024 | 346 |
Thereafter | 3,171 |
Total | $ 4,575 |
Accrued Expenses - Schedule of
Accrued Expenses - Schedule of Accrued Expenses (Details) - USD ($) $ in Thousands | Oct. 31, 2019 | Oct. 31, 2018 |
Payables and Accruals [Abstract] | ||
Salaries and other compensation | $ 158 | $ 2,035 |
Vendors | 3,194 | 3,660 |
Professional fees | 126 | 490 |
Total accrued expenses | $ 3,478 | $ 6,185 |
Common Stock Purchase Warrant_3
Common Stock Purchase Warrants and Warrant Liability (Details Narrative) $ in Thousands | Mar. 14, 2019USD ($)$ / sharesshares | Jul. 31, 2019$ / sharesshares | Apr. 30, 2019$ / sharesshares | Jan. 31, 2018shares | Oct. 31, 2019USD ($)$ / sharesshares | Oct. 31, 2018USD ($)$ / sharesshares | Sep. 11, 2018USD ($)$ / shares | Oct. 31, 2017USD ($) |
Class of Warrant or Right [Line Items] | ||||||||
Number of warrants to purchase common stock | shares | 432,142 | 944,635 | ||||||
Exercise price | $ 0.372 | $ 22.50 | ||||||
Warrants outstanding | shares | 432,142 | 944,635 | ||||||
Number of common stock shares issued | shares | 17,869,662 | |||||||
Loss on shares issued in settlement of warrants | $ | $ (1,607) | |||||||
Number of common stock shares sold | shares | 58,776 | |||||||
Fair value of the warrant liability | $ | 19 | 6,517 | ||||||
Income on fair value of warrants | $ | $ 2,600 | $ 3,400 | ||||||
Exercise Price [Member] | ||||||||
Class of Warrant or Right [Line Items] | ||||||||
Warrants, measurement input | 22.50 | 12.75 | ||||||
Stock Price [Member] | ||||||||
Class of Warrant or Right [Line Items] | ||||||||
Warrants, measurement input | 6.45 | 22.50 | ||||||
Expected Term [Member] | ||||||||
Class of Warrant or Right [Line Items] | ||||||||
Warrants, term | 5 years 6 months | 6 years | ||||||
Volatility [Member] | ||||||||
Class of Warrant or Right [Line Items] | ||||||||
Warrants, measurement input fair value, percentage | 96.37% | 99.21% | ||||||
Risk Free Interest Rate [Member] | ||||||||
Class of Warrant or Right [Line Items] | ||||||||
Warrants, measurement input fair value, percentage | 2.44% | 2.91% | ||||||
Private Exchange Agreement [Member] | ||||||||
Class of Warrant or Right [Line Items] | ||||||||
Number of warrants to purchase common stock | shares | 856,865 | |||||||
Exercise price | $ 22.50 | |||||||
Warrant expiration | Sep. 11, 2024 | |||||||
Private Exchange Agreement [Member] | Investor [Member] | ||||||||
Class of Warrant or Right [Line Items] | ||||||||
Number of common stock shares issued | shares | 856,865 | |||||||
Fair value of warrant | $ | $ 3,900 | |||||||
Equity Warrants [Member] | ||||||||
Class of Warrant or Right [Line Items] | ||||||||
Warrants outstanding | shares | 359,863 | 191 | ||||||
Warrant Liability [Member] | ||||||||
Class of Warrant or Right [Line Items] | ||||||||
Warrants outstanding | shares | 72,279 | 944,444 | ||||||
Warrants, term | 6 years | |||||||
Number of common stock shares sold | shares | 10,650,000 | 2,500,000 | ||||||
Fair value of the warrant liability | $ | $ 19 | $ 6,517 | ||||||
Income on fair value of warrants | $ | $ (2,589) | $ (3,400) | ||||||
Warrant Liability [Member] | Pre-funded Warrants [Member] | ||||||||
Class of Warrant or Right [Line Items] | ||||||||
Number of warrants to purchase common stock | shares | 13,656,000 | |||||||
Warrant Liability [Member] | Exercise Price [Member] | ||||||||
Class of Warrant or Right [Line Items] | ||||||||
Warrants, measurement input | 0.37 | 22.50 | ||||||
Warrant Liability [Member] | Stock Price [Member] | ||||||||
Class of Warrant or Right [Line Items] | ||||||||
Warrants, measurement input | 0.32 | 8.40 | ||||||
Warrant Liability [Member] | Expected Term [Member] | ||||||||
Class of Warrant or Right [Line Items] | ||||||||
Warrants, term | 4 years 10 months 14 days | 5 years 10 months 14 days | ||||||
Warrant Liability [Member] | Investor [Member] | ||||||||
Class of Warrant or Right [Line Items] | ||||||||
Fair value of warrant | $ | $ 9,900 | |||||||
Warrants [Member] | ||||||||
Class of Warrant or Right [Line Items] | ||||||||
Exercise price | $ 22.50 | |||||||
Warrants outstanding | shares | 944,444 | |||||||
Warrants, term | 6 years | |||||||
Minimum [Member] | ||||||||
Class of Warrant or Right [Line Items] | ||||||||
Exercise price | $ 0 | $ 22.50 | ||||||
Minimum [Member] | Private Exchange Agreement [Member] | ||||||||
Class of Warrant or Right [Line Items] | ||||||||
Exercise price | $ 4.50 | |||||||
Minimum [Member] | Warrant Liability [Member] | ||||||||
Class of Warrant or Right [Line Items] | ||||||||
Exercise price | $ 0.372 | $ 3.72 | ||||||
Maximum [Member] | ||||||||
Class of Warrant or Right [Line Items] | ||||||||
Exercise price | $ 281.25 | $ 281.25 | ||||||
Maximum [Member] | Private Exchange Agreement [Member] | ||||||||
Class of Warrant or Right [Line Items] | ||||||||
Exercise price | $ 22.50 | |||||||
Maximum [Member] | Warrant Liability [Member] | ||||||||
Class of Warrant or Right [Line Items] | ||||||||
Exercise price | $ 3.72 | $ 4.50 |
Common Stock Purchase Warrant_4
Common Stock Purchase Warrants and Warrant Liability - Schedule of Outstanding Warrants (Details) - $ / shares | 12 Months Ended | |
Oct. 31, 2019 | Oct. 31, 2018 | |
Class of Warrant or Right [Line Items] | ||
Exercise Price | $ 0.372 | $ 22.50 |
Number of Shares Underlying Warrants | 432,142 | 944,635 |
Exercise Price Range One [Member] | ||
Class of Warrant or Right [Line Items] | ||
Exercise Price | $ 281.25 | |
Number of Shares Underlying Warrants | 359,838 | 25 |
Expiration Date | Jul. 31, 2024 | |
Summary of Warrants | July 2019 Public Offering | Other Warrants |
Exercise Price Range Two [Member] | ||
Class of Warrant or Right [Line Items] | ||
Exercise Price | $ 281.25 | $ 56.25 |
Number of Shares Underlying Warrants | 25 | 166 |
Expiration Date | Mar. 31, 2019 | |
Summary of Warrants | Other Warrants | March 2014 Public Offering- Placement Agent |
Exercise Price Range Three [Member] | ||
Class of Warrant or Right [Line Items] | ||
Exercise Price | $ 0.372 | $ 22.50 |
Number of Shares Underlying Warrants | 72,279 | 944,444 |
Expiration Date | Sep. 30, 2024 | Sep. 30, 2024 |
Summary of Warrants | September 2018 Public Offering | September 2018 Public Offering |
Common Stock Purchase Warrant_5
Common Stock Purchase Warrants and Warrant Liability - Schedule of Warrants Activity (Details) - USD ($) $ / shares in Units, $ in Thousands | 12 Months Ended | ||
Oct. 31, 2019 | Oct. 31, 2018 | ||
Common Stock Purchase Warrants And Warrant Liability | |||
Number of Warrants, Outstanding and exercisable warrants, Beginning balance | 944,635 | 206,160 | |
Number of Warrants, Issued | 31,885,500 | 944,444 | |
Number of Warrants, Exercised | [1] | (31,540,962) | |
Number of Warrants, Exchanged | (856,865) | ||
Number of Warrants, Expired | (166) | (205,969) | |
Number of Warrants, Outstanding and exercisable warrants, Ending balance | 432,142 | 944,635 | |
Weighted Average Exercise Price, Outstanding and exercisable warrants, Beginning | $ 22.50 | $ 75 | |
Weighted Average Exercise Price, Issued | 22.50 | ||
Weighted Average Exercise Price, Expired | 75 | ||
Weighted Average Exercise Price, Outstanding and exercisable warrants, Ending | $ 0.08 | $ 22.50 | |
Weighted Average Remaining Contractual Life In Years, Outstanding and exercisable warrants, Beginning | 5 years 10 months 14 days | 11 months 1 day | |
Weighted Average Remaining Contractual Life In Years, Outstanding and exercisable warrants, Ending balance | 4 years 9 months 3 days | 5 years 10 months 14 days | |
Aggregate Intrinsic Value, Beginning | |||
Aggregate Intrinsic Value, Ending | $ 114,069 | ||
[1] | Includes the cashless exercise of 17,869,662 warrants that resulted in the issuance of 17,869,662 shares of common stock. |
Common Stock Purchase Warrant_6
Common Stock Purchase Warrants and Warrant Liability - Schedule of Warrants Activity (Details) (Parenthetical) | 12 Months Ended |
Oct. 31, 2019shares | |
Common Stock Purchase Warrants And Warrant Liability | |
Cashless warrant exercise | 17,869,662 |
Number of common stock shares issued | 17,869,662 |
Common Stock Purchase Warrant_7
Common Stock Purchase Warrants and Warrant Liability - Schedule of Assumptions Used in Warrant Liability (Details) - $ / shares | Oct. 31, 2019 | Mar. 14, 2019 | Oct. 31, 2018 | Sep. 11, 2018 |
Exercise Price [Member] | ||||
Class of Warrant or Right [Line Items] | ||||
Warrants, measurement input | 22.50 | 12.75 | ||
Stock Price [Member] | ||||
Class of Warrant or Right [Line Items] | ||||
Warrants, measurement input | 6.45 | 22.50 | ||
Expected Term [Member] | ||||
Class of Warrant or Right [Line Items] | ||||
Warrants, term | 5 years 6 months | 6 years | ||
Warrant Liability [Member] | ||||
Class of Warrant or Right [Line Items] | ||||
Warrants, term | 6 years | |||
Warrant Liability [Member] | Exercise Price [Member] | ||||
Class of Warrant or Right [Line Items] | ||||
Warrants, measurement input | 0.37 | 22.50 | ||
Warrant Liability [Member] | Stock Price [Member] | ||||
Class of Warrant or Right [Line Items] | ||||
Warrants, measurement input | 0.32 | 8.40 | ||
Warrant Liability [Member] | Expected Term [Member] | ||||
Class of Warrant or Right [Line Items] | ||||
Warrants, term | 4 years 10 months 14 days | 5 years 10 months 14 days | ||
Warrant Liability [Member] | Volatility [Member] | ||||
Class of Warrant or Right [Line Items] | ||||
Warrants, measurement input percentage | 100.99% | 97.47% | ||
Warrant Liability [Member] | Risk Free Interest Rate [Member] | ||||
Class of Warrant or Right [Line Items] | ||||
Warrants, measurement input percentage | 1.51% | 3.03% |
Share Based Compensation (Detai
Share Based Compensation (Details Narrative) - USD ($) $ in Thousands | Mar. 29, 2019 | Mar. 21, 2018 | Jan. 02, 2018 | Apr. 05, 2017 | Jan. 31, 2018 | Oct. 31, 2019 | Oct. 31, 2018 | Feb. 21, 2019 | Jan. 02, 2019 | Mar. 10, 2016 |
Issuance of common stock | 58,776 | |||||||||
Common stock authorized for issuance | 170,000,000 | 170,000,000 | ||||||||
Common stock, shares outstanding | 50,201,671 | 4,634,189 | ||||||||
Reverse stock split, description | 1 for 15 reverse stock split | |||||||||
Unrecognized compensation cost related to non-vested stock option awards | $ 1,300 | |||||||||
Unrecognized compensation cost related to non-vested remaining weighted average vesting period | 1 year 7 months 24 days | |||||||||
Stock compensation expense | $ 2,002 | $ 6,983 | ||||||||
Compensation cost related to outstanding stock options | $ 1,200 | $ 3,700 | ||||||||
Number of options, granted | 265,882 | 167,871 | ||||||||
Fair value of option granted | $ 500 | $ 4,100 | ||||||||
Share-based compensation options expiration date | Mar. 21, 2023 | |||||||||
Expenses recorded under employee stock purchase plan | $ 20 | 43 | ||||||||
Two Board Members [Member] | ||||||||||
Stock compensation expense | 77 | |||||||||
Restricted Stock Units (RSUs) [Member] | ||||||||||
Fair value of equity purchases value | 51 | 1,600 | ||||||||
Unrecognized compensation cost related to non-vested stock option awards | $ 300 | |||||||||
Unrecognized compensation cost related to non-vested remaining weighted average vesting period | 1 year 2 months 12 days | |||||||||
Aggregate intrinsic value of non-vested RSU | $ 5 | |||||||||
Restricted Stock Units (RSUs) [Member] | Chief Financial Officer [Member] | ||||||||||
Stock compensation expense | 100 | |||||||||
Restricted Stock Units (RSUs) [Member] | Chief Operating Officer [Member] | ||||||||||
Stock compensation expense | $ 300 | |||||||||
Employee Stock Awards [Member] | ||||||||||
Share-based compensation, common stock, shares | 12,245 | 48,874 | ||||||||
Share-based compensation, shares on net basis after employee payroll taxes | 45,830 | 45,830 | ||||||||
Stock compensation expense | $ 800 | $ 3,100 | ||||||||
Director Stock Awards [Member] | ||||||||||
Stock compensation expense | $ 0 | $ 200 | ||||||||
Issuance of common stock issued for share based compensation | 0 | 5,000 | ||||||||
Maximum [Member] | ||||||||||
Common stock authorized for issuance | 170,000,000 | |||||||||
Minimum [Member] | ||||||||||
Common stock authorized for issuance | 95,000,000 | |||||||||
2015 Plan [Member] | ||||||||||
Shares of common stock outstanding, percentage | 5.00% | 5.00% | ||||||||
Common stock, shares outstanding | 137,743 | 166,667 | 166,667 | |||||||
Common stock reserved for issuance under plan | 26,161 | |||||||||
2015 Plan [Member] | Maximum [Member] | ||||||||||
Common stock authorized for issuance | 95,000,000 | 406,667 | 65,000,000 | 306,667 | ||||||
2015 Plan [Member] | Minimum [Member] | ||||||||||
Common stock authorized for issuance | 65,000,000 | 306,667 | 45,000,000 | 240,000 | ||||||
2015 Plan [Member] | Additional Shares [Member] | Maximum [Member] | ||||||||||
Issuance of common stock | 43,333 | |||||||||
2018 Employee Stock Purchase Plan [Member] | ||||||||||
Common stock reserved for issuance under plan | 1,000,000 | |||||||||
Discount price percentage | 15.00% | |||||||||
Employee stock purchase plan description | The Company's shareholders on March 21, 2018. The 2018 ESPP allows employees to purchase common stock of the Company at a 15% discount to the market price on designated exercise dates. Employees were eligible to participate in the 2018 ESPP beginning May 1, 2018. 1,000,000 shares of the Company's Common stock are reserved for issuance under the 2018 ESPP. | |||||||||
2018 Employee Stock Purchase Plan [Member] | ||||||||||
Common stock reserved for issuance under plan | 990,665 | |||||||||
Number of shares issued under employee stock purchase plan | 7,435 | |||||||||
Expenses recorded under employee stock purchase plan | $ 2 | |||||||||
2011 & 2018 Employee Stock Purchase Plans [Member] | ||||||||||
Number of shares issued under employee stock purchase plan | 2,611 | |||||||||
Expenses recorded under employee stock purchase plan | $ 7 | |||||||||
Stock Split [Member] | 2015 Plan [Member] | ||||||||||
Issuance of common stock | 240,000 |
Share Based Compensation - Summ
Share Based Compensation - Summary of Share Based Compensation Expense (Details) - USD ($) $ in Thousands | 12 Months Ended | |
Oct. 31, 2019 | Oct. 31, 2018 | |
Share-based compensation expense | $ 2,002 | $ 6,983 |
Research and Development [Member] | ||
Share-based compensation expense | 1,036 | 2,836 |
General and Administrative [Member] | ||
Share-based compensation expense | $ 966 | $ 4,147 |
Share Based Compensation - Su_2
Share Based Compensation - Summary of RSU Activity and Related Information (Details) - Restricted Stock Units (RSUs) [Member] - $ / shares | 12 Months Ended | |
Oct. 31, 2019 | Oct. 31, 2018 | |
Number of RSUs, Unvested Beginning Balance | 32,614 | 90,870 |
Number of RSUs, Granted | 27,330 | |
Number of RSUs, Vested | (12,257) | (53,873) |
Number of RSUs, Cancelled | (5,651) | (31,713) |
Number of RSUs, Unvested Ending Balance | 14,706 | 32,614 |
Weighted-Average Grant Date Fair Value, Unvested Beginning Balance | $ 70.41 | $ 128.10 |
Weighted-Average Grant Date Fair Value, Granted | 29.55 | |
Weighted-Average Grant Date Fair Value, Vested | 78.41 | 115.65 |
Weighted-Average Grant Date Fair Value, Cancelled | 112.39 | 123.45 |
Weighted-Average Grant Date Fair Value, Unvested Ending Balance | $ 47.62 | $ 70.41 |
Share Based Compensation - Su_3
Share Based Compensation - Summary of Changes in Stock Option Plan (Details) - USD ($) $ / shares in Units, $ in Thousands | 12 Months Ended | |
Oct. 31, 2019 | Oct. 31, 2018 | |
Share-based Payment Arrangement [Abstract] | ||
Number of Options, Beginning Balance | 330,071 | 259,571 |
Number of Options, Granted | 265,882 | 167,871 |
Number of Options, Cancelled or Expired | (35,463) | (97,371) |
Number of Options, Ending Balance | 560,490 | 330,071 |
Number of Options, Vested and Exercisable | 240,015 | |
Weighted-Average Exercise Price, Outstanding, Beginning | $ 122.79 | $ 187.65 |
Weighted-Average Exercise Price, Granted | 2.36 | 30.90 |
Weighted-Average Exercise Price, Cancelled or Expired | 29.52 | 137.10 |
Weighted-Average Exercise Price, Outstanding, Ending | 71.56 | $ 122.79 |
Weighted-Average Exercise Price, Vested and Exercisable | $ 155.25 | |
Weighted Average Remaining Contractual Life In Years, Outstanding, Beginning | 6 years 6 months 21 days | 5 years 8 months 19 days |
Weighted Average Remaining Contractual Life In Years, Outstanding, Ending balance | 7 years 4 months 2 days | 6 years 6 months 21 days |
Weighted Average Remaining Contractual Life In Years, Vested and Exercisable | 4 years 6 months | |
Aggregate Intrinsic Value, Beginning | ||
Aggregate Intrinsic Value, Ending | 1 | |
Aggregate Intrinsic Value, Vested and Exercisable |
Share Based Compensation - Su_4
Share Based Compensation - Summary of Outstanding and Exercisable Options (Details) - USD ($) $ / shares in Units, $ in Thousands | 12 Months Ended | ||
Oct. 31, 2019 | Oct. 31, 2018 | Oct. 31, 2017 | |
Options Outstanding, Number Outstanding | 560,490 | 330,071 | 259,571 |
Options Weighted Average Remaining Contractual Term | 6 years 6 months 21 days | 5 years 8 months 19 days | |
Options Outstanding, Weighted Average Exercise Price | $ 71.56 | $ 122.79 | $ 187.65 |
Options Outstanding, Intrinsic Value | $ 1 | ||
Options Exercisable, Number Outstanding | 240,015 | ||
Options Exercisable, Weighted Average Exercise Price | $ 155.25 | ||
Options Exercisable, Intrinsic Value | |||
Exercise Price Range One [Member] | |||
Range, lower limit | $ 0.30 | ||
Range, upper limit | $ 10 | ||
Options Outstanding, Number Outstanding | 249,329 | ||
Options Weighted Average Remaining Contractual Term | 9 years 8 months 9 days | ||
Options Outstanding, Weighted Average Exercise Price | $ 2.35 | ||
Options Outstanding, Intrinsic Value | $ 1 | ||
Options Exercisable, Number Outstanding | 178 | ||
Options Weighted Average Remaining Contractual Term Exercisable | 8 years 11 months 23 days | ||
Options Exercisable, Weighted Average Exercise Price | $ 9 | ||
Options Exercisable, Intrinsic Value | |||
Exercise Price Range Two [Member] | |||
Range, lower limit | $ 10.01 | ||
Range, upper limit | $ 100 | ||
Options Outstanding, Number Outstanding | 119,753 | ||
Options Weighted Average Remaining Contractual Term | 8 years 6 months 10 days | ||
Options Outstanding, Weighted Average Exercise Price | $ 29.70 | ||
Options Outstanding, Intrinsic Value | |||
Options Exercisable, Number Outstanding | 52,846 | ||
Options Weighted Average Remaining Contractual Term Exercisable | 8 years 2 months 1 day | ||
Options Exercisable, Weighted Average Exercise Price | $ 34.15 | ||
Options Exercisable, Intrinsic Value | |||
Exercise Price Range Three [Member] | |||
Range, lower limit | $ 100.01 | ||
Range, upper limit | $ 200 | ||
Options Outstanding, Number Outstanding | 101,490 | ||
Options Weighted Average Remaining Contractual Term | 3 years 11 months 19 days | ||
Options Outstanding, Weighted Average Exercise Price | $ 167.11 | ||
Options Outstanding, Intrinsic Value | |||
Options Exercisable, Number Outstanding | 97,073 | ||
Options Weighted Average Remaining Contractual Term Exercisable | 3 years 10 months 6 days | ||
Options Exercisable, Weighted Average Exercise Price | $ 169.45 | ||
Options Exercisable, Intrinsic Value | |||
Exercise Price Range Four [Member] | |||
Range, lower limit | $ 200.01 | ||
Range, upper limit | $ 318.75 | ||
Options Outstanding, Number Outstanding | 89,918 | ||
Options Weighted Average Remaining Contractual Term | 3 years 15 days | ||
Options Outstanding, Weighted Average Exercise Price | $ 211.39 | ||
Options Outstanding, Intrinsic Value | |||
Options Exercisable, Number Outstanding | 89,918 | ||
Options Weighted Average Remaining Contractual Term Exercisable | 3 years 15 days | ||
Options Exercisable, Weighted Average Exercise Price | $ 211.39 | ||
Options Exercisable, Intrinsic Value |
Share Based Compensation - Su_5
Share Based Compensation - Summary of Fair Value of Stock Options Granted of BSM (Details) - $ / shares | 12 Months Ended | |
Oct. 31, 2019 | Oct. 31, 2018 | |
Weighted average fair value of options granted | $ 1.84 | $ 1.61 |
Expected Dividends | 0.00% | 0.00% |
Minimum [Member] | ||
Expected Term | 5 years 6 months | 5 years 4 months 6 days |
Expected Volatility | 90.24% | 91.14% |
Risk Free Interest Rate | 1.35% | 1.81% |
Maximum [Member] | ||
Expected Term | 6 years 6 months 3 days | 6 years 6 months 3 days |
Expected Volatility | 104.99% | 100.34% |
Risk Free Interest Rate | 3.15% | 3.16% |
Collaboration and Licensing A_2
Collaboration and Licensing Agreements (Details Narrative) - USD ($) $ / shares in Units, $ in Thousands | Feb. 08, 2019 | Dec. 10, 2018 | Aug. 02, 2016 | Mar. 19, 2014 | Oct. 31, 2019 | Oct. 31, 2018 | Oct. 31, 2014 |
Number of common stock shares issued | 17,869,662 | ||||||
Value of stock purchased | $ 24,471 | $ 26,670 | |||||
Revenue | 20,884 | 6,063 | |||||
Global BioPharma, Inc [Member] | |||||||
Payment to contract research organization | 2,250 | ||||||
License and Service [Member] | Global BioPharma, Inc [Member] | |||||||
Revenue | 250 | 250 | |||||
Merck Agreement [Member] | |||||||
Agreement expenses | 900 | 2,400 | |||||
Amgen Agreement [Member] | |||||||
Upfront payment | $ 40,000 | ||||||
Number of common stock shares issued | 203,163 | ||||||
Share issued price per share | $ 123 | ||||||
Value of stock purchased | $ 25,000 | ||||||
Development, regulatory and sales milestone payments | 475,000 | ||||||
Upfront payment recorded as deferred revenue | $ 40,000 | $ 40,000 | |||||
Deferred revenue | 18,200 | ||||||
Cumulative catch-up revenue | $ 2,600 | $ 15,600 | |||||
Revenue | 20,600 | 5,800 | |||||
Reduction in research and development expenses | 2,000 | 5,800 | |||||
Aratana Agreement [Member] | |||||||
Upfront payment | $ 1,000 | ||||||
Development, regulatory and sales milestone payments | 36,500 | ||||||
Licensing revenue | $ 1,000 | ||||||
Additional, cumulative sales milestone payments | $ 15,000 | ||||||
Aratana Agreement [Member] | Royalty [Member] | |||||||
Revenue | $ 8 | $ 3 |
Commitments and Contingencies_2
Commitments and Contingencies (Details Narrative) - USD ($) $ in Thousands | Sep. 19, 2018 | Oct. 31, 2019 | Oct. 31, 2018 |
Rent expense | $ 1,200 | $ 1,200 | |
Corporate Office and Manufacturing Facility Lease [Member] | |||
Operating lease expiring date | Nov. 30, 2025 | ||
Especificos Stendhal SA de CV [Member] | |||
Damages sought value by plaintiff | $ 3,000 | ||
Litigation expense | 300 | ||
Due from related party | $ 3,000 |
Commitments and Contingencies -
Commitments and Contingencies - Summary of Future Minimum Payments of Operating Leases (Details) $ in Thousands | Oct. 31, 2019USD ($) |
Commitments and Contingencies Disclosure [Abstract] | |
2020 | $ 1,233 |
2021 | 1,318 |
2022 | 1,369 |
2023 | 1,395 |
2024 | 1,419 |
Thereafter | 1,564 |
Total | $ 8,298 |
Income Taxes (Details Narrative
Income Taxes (Details Narrative) - USD ($) $ in Thousands | Dec. 22, 2017 | Jan. 31, 2018 | Oct. 31, 2019 | Oct. 31, 2018 |
Net operating loss carry-forward | $ 68,300 | $ 265,800 | ||
Operating loss expiration year | 2023 | |||
Income tax reconciliation description | The U.S. government enacted comprehensive tax legislation commonly referred to as the Tax Cuts and Jobs Act (the 'Tax Act"). The Tax Act made broad and significant changes to the U.S. tax code including, but not limited to, a change in the federal rate from 34% to 21%. As a result of the enactment of the legislation, the Company recorded a one-time reduction to its deferred tax assets of approximately $34.4 million, which was offset by a reduction in the valuation allowance. When a U.S. federal tax rate change occurs during a fiscal year, taxpayers are required to compute a weighted daily average rate for the fiscal year of enactment. As a result of the Tax Act, Advaxis has calculated a blended U.S. federal statutory corporate income tax rate of approximately 23% for the year ended October 31, 2018 and applied this rate in computing the income tax provision for year ending October 31, 2018. The blended U.S. federal statutory corporate income tax rate of 23% is the weighted daily average rate between the pre-enactment U.S. federal statutory tax rate of 34% applicable to the Company's 2018 fiscal year prior to the Effective Date and the post-enactment U.S. federal statutory tax rate of 21% applicable to the 2018 fiscal year thereafter. Advaxis expects the U.S. federal statutory rate to be 21% for fiscal years beginning after October 31, 2018. | NOLs may be subject to limitation under Internal Revenue Code Section 382 should there be a greater than 50% ownership change as determined under the regulations. | ||
Total net operating loss carry-forward | $ 278,100 | |||
Net operating loss and deferred tax asset does not include nol's | 209,800 | |||
New jersey state net operating loss carryovers | $ 116,600 | |||
Income tax effective tax rate | 21.00% | 0.00% | 0.00% | |
Deferred tax assets | $ 34,400 | $ 58,432 | $ 89,760 | |
Amount received from sale of net operating losses | $ 4,500 | |||
Internal Revenue Code [Member] | ||||
Net operating loss carry-forward | $ 68,300 |
Income Taxes - Schedule of Inco
Income Taxes - Schedule of Income Tax Provision (Benefit) (Details) - USD ($) $ in Thousands | 12 Months Ended | |
Oct. 31, 2019 | Oct. 31, 2018 | |
Income Tax Disclosure [Abstract] | ||
Federal Current | ||
Federal Deferred | 32,673 | 22,325 |
State and Local Current | ||
State and Local Deferred | (1,634) | (5,449) |
Change in valuation allowance | (31,039) | (16,876) |
Income tax provision (benefit) | $ 50 | $ 50 |
Income Taxes - Schedule of Defe
Income Taxes - Schedule of Deferred Tax Assets (Liabilities) (Details) - USD ($) $ in Thousands | Oct. 31, 2019 | Oct. 31, 2018 | Dec. 22, 2017 |
Income Tax Disclosure [Abstract] | |||
Net operating loss carryovers | $ 22,627 | $ 65,002 | |
Stock-based compensation | 11,767 | 12,081 | |
Research and development credits | 10,234 | 6,843 | |
Capitalized R&D costs | 13,399 | ||
Deferred revenue | 5,247 | ||
Other deferred tax assets | 405 | 587 | |
Total deferred tax assets | 58,432 | 89,760 | $ 34,400 |
Valuation allowance | (56,822) | (87,862) | |
Deferred tax asset, net of valuation allowance | 1,610 | 1,898 | |
Other deferred tax liabilities | (1,610) | (1,898) | |
Total deferred tax liabilities | (1,610) | (1,898) | |
Net deferred tax asset (liability) |
Income Taxes - Schedule of Expe
Income Taxes - Schedule of Expected Tax (Expense) Benefit Based on Statutory Rate with Actual Tax Expense Benefit (Details) | Dec. 22, 2017 | Oct. 31, 2019 | Oct. 31, 2018 |
Income Tax Disclosure [Abstract] | |||
US Federal statutory rate | 21.00% | 23.17% | |
State income tax, net of federal benefit | 9.84% | 8.19% | |
Permanent differences | 1.23% | 1.22% | |
Research and development credits | 17.30% | (0.38%) | |
Change in valuation allowance | (47.02%) | 25.37% | |
Tax Cuts and Jobs Act | 0.00% | (53.93%) | |
Other | (2.34%) | (3.64%) | |
Income tax (provision) benefit | 21.00% | 0.00% | 0.00% |
Stockholders' Equity (Details N
Stockholders' Equity (Details Narrative) - USD ($) $ / shares in Units, $ in Thousands | 1 Months Ended | 12 Months Ended | 72 Months Ended | |||||
Jul. 31, 2019 | Apr. 30, 2019 | Sep. 30, 2018 | Feb. 28, 2018 | Jan. 31, 2018 | Oct. 31, 2019 | Oct. 31, 2018 | Oct. 31, 2019 | |
Number of common stock shares sold | 58,776 | |||||||
Proceeds from sale of common shares | $ 2,700 | |||||||
Number of shares issued, shares | 17,869,662 | |||||||
Number of shares issued, value | $ 24,471 | $ 26,670 | ||||||
Net proceeds from offering | $ 27,000 | $ 292,200 | ||||||
Number of warrants to purchase common stock | 432,142 | 944,635 | 432,142 | |||||
Common Stock [Member] | ||||||||
Number of shares issued, shares | 13,150,000 | 1,777,778 | ||||||
Number of shares issued, value | $ 13 | $ 2 | ||||||
Public Offering [Member] | ||||||||
Number of shares issued, shares | 2,500,000 | 666,667 | ||||||
Share price per share | $ 4 | $ 18 | $ 30 | |||||
Number of shares issued, value | $ 9,000 | $ 20,000 | ||||||
Net proceeds from offering | $ 18,400 | |||||||
Underwritten Public Offering [Member] | ||||||||
Number of shares issued, shares | 10,650,000 | 1,111,111 | ||||||
Number of shares issued, value | $ 17,000 | $ 20,000 | ||||||
Net proceeds from offering | $ 15,500 | $ 18,200 | ||||||
Number of warrants to purchase common stock | 944,444 | |||||||
Sale of stock price per share | $ 0.85 | |||||||
Warrants, term | 5 years | 6 years | ||||||
Sold price per share transaction | Each share of common stock was sold together in a fixed combination with a warrant to purchase 0.75 shares of common stock for $0.70, and each pre-funded warrant was sold together in a fixed combination with a warrant to purchase 0.75 shares of common stock for $0.699. The pre-funded warrants are exercisable immediately, do not expire and have an exercise price of $0.001 per share. The warrants are exercisable immediately, expire five years from the date of issuance, have an exercise price of $2.80 per share and are subject to anti-dilution and other adjustments for certain stock splits, stock dividends, or recapitalizations. The warrants also provide that if during the period of time between the date that is the earlier of (i) 30 days after issuance and (ii) if the common stock trades an aggregate of more than 35,000,000 shares after the pricing of the offering, and ending 15 months after issuance, the weighted-average price of common stock immediately prior to the exercise date is lower than the then-applicable exercise price per share, each Common Warrant may be exercised, at the option of the holder, on a cashless basis for one share of Common Stock. | |||||||
Underwritten Public Offering [Member] | Maximum [Member] | ||||||||
Number of warrants to purchase common stock | 17,142,000 | |||||||
Underwritten Public Offering [Member] | Common Stock [Member] | ||||||||
Sale of stock price per share | $ 0.70 | |||||||
Underwritten Public Offering [Member] | Pre-funded Warrants [Member] | ||||||||
Number of warrants to purchase common stock | 13,656,000 | |||||||
Sale of stock price per share | $ 0.75 |
Fair Value - Schedule of Fair V
Fair Value - Schedule of Fair Value, Assets and Liabilities Measured on Recurring Basis (Details) - USD ($) $ in Thousands | Oct. 31, 2019 | Oct. 31, 2018 |
Common stock warrant liability, warrants exercisable | $ 19 | $ 6,517 |
Fair Value, Inputs, Level 1 [Member] | ||
Common stock warrant liability, warrants exercisable | ||
Fair Value, Inputs, Level 2 [Member] | ||
Common stock warrant liability, warrants exercisable | ||
Fair Value, Inputs, Level 3 [Member] | ||
Common stock warrant liability, warrants exercisable | $ 19 | $ 6,517 |
Fair Value - Schedule of Fair_2
Fair Value - Schedule of Fair Value, Assets and Liabilities Measured on Recurring Basis (Details) (Parenthetical) - $ / shares | Oct. 31, 2019 | Oct. 31, 2018 |
Fair Value Disclosures [Abstract] | ||
Warrant exercise price per share | $ 0.372 | $ 22.50 |
Fair Value - Schedule of Change
Fair Value - Schedule of Changes in Fair Value of Warrant Liabilities (Details) - USD ($) $ in Thousands | 12 Months Ended | |
Oct. 31, 2019 | Oct. 31, 2018 | |
Beginning balance | $ 6,517 | |
Warrant exercises | 122 | |
Change in fair value | 2,600 | $ 3,400 |
Ending Balance | 19 | 6,517 |
Warrant Liability [Member] | ||
Beginning balance | 6,517 | |
Issuance of warrants | 9,917 | |
Shares issued in settlement of warrants | (3,856) | |
Warrant exercises | (53) | |
Change in fair value | (2,589) | (3,400) |
Ending Balance | $ 19 | $ 6,517 |
Employee Benefit Plan (Details
Employee Benefit Plan (Details Narrative) - USD ($) $ in Thousands | 12 Months Ended | |
Oct. 31, 2019 | Oct. 31, 2018 | |
401(k) Plan [Member] | ||
Employee contributions, amount | $ 200 | $ 400 |