Cover
Cover - shares | 3 Months Ended | |
Oct. 31, 2021 | Dec. 15, 2021 | |
Cover [Abstract] | ||
Document Type | 10-Q | |
Amendment Flag | false | |
Document Quarterly Report | true | |
Document Transition Report | false | |
Document Period End Date | Oct. 31, 2021 | |
Document Fiscal Period Focus | Q1 | |
Document Fiscal Year Focus | 2022 | |
Current Fiscal Year End Date | --07-31 | |
Entity File Number | 000-54318 | |
Entity Registrant Name | ONCOSEC MEDICAL INCORPORATED | |
Entity Central Index Key | 0001444307 | |
Entity Tax Identification Number | 98-0573252 | |
Entity Incorporation, State or Country Code | NV | |
Entity Address, Address Line One | 24 NORTH MAIN STREET | |
Entity Address, City or Town | PENNINGTON | |
Entity Address, State or Province | NJ | |
Entity Address, Postal Zip Code | 08534 | |
City Area Code | (855) | |
Local Phone Number | 662-6732 | |
Title of 12(b) Security | Common Stock, par value $0.0001 per share | |
Trading Symbol | ONCS | |
Security Exchange Name | NASDAQ | |
Entity Current Reporting Status | Yes | |
Entity Interactive Data Current | Yes | |
Entity Filer Category | Non-accelerated Filer | |
Entity Small Business | true | |
Entity Emerging Growth Company | false | |
Entity Shell Company | false | |
Entity Common Stock, Shares Outstanding | 39,333,683 |
Condensed Consolidated Balance
Condensed Consolidated Balance Sheets - USD ($) | Oct. 31, 2021 | Jul. 31, 2021 |
Current assets | ||
Cash and cash equivalents | $ 35,706,755 | $ 45,951,233 |
Prepaid expenses and other current assets | 2,983,727 | 3,228,191 |
Total Current Assets | 38,690,482 | 49,179,424 |
Property and equipment, net | 874,636 | 928,821 |
Intangible assets, net | 430,941 | 448,412 |
Operating lease right-of-use assets | 5,350,864 | 5,445,744 |
Other long-term assets | 278,000 | 273,523 |
Total Assets | 45,624,923 | 56,275,924 |
Current liabilities | ||
Accounts payable and accrued liabilities | 4,513,535 | 5,561,645 |
Accrued compensation related | 487,368 | 320,655 |
Operating lease liabilities | 1,002,038 | 845,483 |
Notes payable | 867,009 | 1,234,133 |
Total Current Liabilities | 6,869,950 | 7,961,916 |
Operating lease liabilities, net of current portion | 4,976,279 | 5,238,207 |
Liability under co-promotion agreement - related party | 5,000,000 | 5,000,000 |
Total Liabilities | 16,846,229 | 18,200,123 |
Stockholders’ Equity | ||
Common stock authorized - 100,000,000 common shares with a par value of $0.0001 as of October 31, 2021 and July 31, 2021, common stock issued and outstanding — 39,202,590 and 39,152,610 common shares as of October 31, 2021 and July 31, 2021, respectively | 3,921 | 3,916 |
Additional paid-in capital | 286,979,197 | 286,337,291 |
Warrants issued and outstanding – 1,706,190 warrants as of October 31, 2021 and July 31, 2021 | 3,591,734 | 3,591,734 |
Accumulated other comprehensive loss | (209,502) | (79,109) |
Accumulated deficit | (261,586,656) | (251,778,031) |
Total Stockholders’ Equity | 28,778,694 | 38,075,801 |
Total Liabilities and Stockholders’ Equity | $ 45,624,923 | $ 56,275,924 |
Condensed Consolidated Balanc_2
Condensed Consolidated Balance Sheets (Parenthetical) - $ / shares | Oct. 31, 2021 | Jul. 31, 2021 |
Statement of Financial Position [Abstract] | ||
Common stock, shares authorized | 100,000,000 | 100,000,000 |
Common stock, par value | $ 0.0001 | $ 0.0001 |
Common stock, shares issued | 39,202,590 | 39,152,610 |
Common stock, shares outstanding | 39,202,590 | 39,152,610 |
Warrants issued | 1,706,190 | 1,706,190 |
Warrants outstanding | 1,706,190 | 1,706,190 |
Condensed Consolidated Statemen
Condensed Consolidated Statements of Operations (Unaudited) - USD ($) | 3 Months Ended | |
Oct. 31, 2021 | Oct. 31, 2020 | |
Income Statement [Abstract] | ||
Revenue | ||
Expenses: | ||
Research and development | 6,645,771 | 9,799,361 |
General and administrative | 3,269,723 | 3,240,732 |
Loss from operations | (9,915,494) | (13,040,093) |
Other expense, net | (2,010) | (623) |
Interest expense | (8,045) | (6,134) |
Foreign currency exchange gain (loss), net | 116,924 | (176,917) |
Loss before income taxes | (9,808,625) | (13,223,767) |
Income tax expense | 1,500 | |
Net loss | $ (9,808,625) | $ (13,225,267) |
Basic and diluted net loss per common share | $ (0.25) | $ (0.49) |
Weighted average shares used in computing basic and diluted net loss per common share | 39,177,330 | 26,771,176 |
Condensed Consolidated Statem_2
Condensed Consolidated Statements of Comprehensive Loss (Unaudited) - USD ($) | 3 Months Ended | |
Oct. 31, 2021 | Oct. 31, 2020 | |
Income Statement [Abstract] | ||
Net Loss | $ (9,808,625) | $ (13,225,267) |
Foreign currency translation adjustments | (130,393) | 92,315 |
Comprehensive Loss | $ (9,939,018) | $ (13,132,952) |
Condensed Consolidated Statem_3
Condensed Consolidated Statements of Stockholders' Equity (Unaudited) - USD ($) | Common Stock [Member] | Additional Paid-in Capital [Member] | Warrants [Member] | AOCI Attributable to Parent [Member] | Retained Earnings [Member] | Total |
Beginning balance, value at Jul. 31, 2020 | $ 2,305 | $ 214,789,808 | $ 5,708,127 | $ (19,504) | $ (206,610,300) | $ 13,870,436 |
Balance, shares at Jul. 31, 2020 | 23,054,474 | 3,114,288 | ||||
Stock-based compensation expense | 1,894,022 | 1,894,022 | ||||
Stock-based compensation expense,shares | 6,541 | |||||
Tax withholdings paid on equity awards | (13,532) | (13,532) | ||||
Tax shares sold to pay for tax withholdings on equity awards | 14,113 | 14,113 | ||||
August 2020 Registered Direct Offering, net of $1,464,276 issuance costs | $ 461 | 13,513,177 | 13,513,638 | |||
August 2020 Registered Direct Offering, net of $1,464,276 issuance costs,shares | 4,608,589 | |||||
Common stock issued for services | $ 3 | 84,997 | 85,000 | |||
Common stock issued for services,shares | 25,000 | |||||
Net loss | (13,225,267) | (13,225,267) | ||||
Other comprehensive loss | 92,315 | 92,315 | ||||
Ending balance, value at Oct. 31, 2020 | $ 2,769 | 230,282,585 | $ 5,708,127 | 72,811 | (219,835,567) | 16,230,725 |
Balance, shares at Oct. 31, 2020 | 27,694,604 | 3,114,288 | ||||
Beginning balance, value at Jul. 31, 2021 | $ 3,916 | 286,337,291 | $ 3,591,734 | (79,109) | (251,778,031) | 38,075,801 |
Balance, shares at Jul. 31, 2021 | 39,152,610 | 1,706,190 | ||||
Stock-based compensation expense | $ 4 | 599,903 | 599,907 | |||
Stock-based compensation expense,shares | 37,480 | |||||
Tax withholdings paid on equity awards | (28,119) | (28,119) | ||||
Tax shares sold to pay for tax withholdings on equity awards | 27,623 | 27,623 | ||||
Common stock issued for services | $ 1 | 42,499 | 42,500 | |||
Common stock issued for services,shares | 12,500 | |||||
Net loss | (9,808,625) | (9,808,625) | ||||
Other comprehensive loss | (130,393) | (130,393) | ||||
Ending balance, value at Oct. 31, 2021 | $ 3,921 | $ 286,979,197 | $ 3,591,734 | $ (209,502) | $ (261,586,656) | $ 28,778,694 |
Balance, shares at Oct. 31, 2021 | 39,202,590 | 1,706,190 |
Condensed Consolidated Statem_4
Condensed Consolidated Statements of Stockholders' Equity (Unaudited) (Parenthetical) | 3 Months Ended |
Oct. 31, 2020USD ($) | |
August 2020 [Member] | Registered Direct Offering [Member] | |
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | |
Payments of issuance cost | $ 1,464,276 |
Condensed Consolidated Statem_5
Condensed Consolidated Statements of Cash Flows (Unaudited) - USD ($) | 3 Months Ended | |
Oct. 31, 2021 | Oct. 31, 2020 | |
Operating activities | ||
Net loss | $ (9,808,625) | $ (13,225,267) |
Adjustments to reconcile net loss to net cash used in operating activities: | ||
Depreciation and amortization | 63,996 | 50,044 |
Amortization of right-of-use asset | 94,880 | 209,248 |
Stock-based compensation | 599,907 | 1,894,022 |
Common stock issued for services | 42,500 | 85,000 |
Foreign currency exchange (gain) loss, net | (116,924) | 176,917 |
Changes in operating assets and liabilities: | ||
Prepaid expenses and other current assets | 270,956 | (288,993) |
Other long-term assets | (8) | |
Accounts payable and accrued liabilities | (1,076,281) | 1,605,700 |
Accrued compensation related | 166,712 | (98,505) |
Operating lease liabilities | (105,373) | (146,762) |
Net cash used in operating activities | (9,868,252) | (9,738,604) |
Financing activities | ||
Proceeds from issuance of common stock | 14,977,914 | |
Payment of financing and offering costs | (1,432,861) | |
Principal payments on note payable | (367,124) | (164,376) |
Tax withholdings paid on equity awards | (28,119) | (13,532) |
Tax shares sold to pay for tax withholdings on equity awards | 27,623 | 14,113 |
Net cash (used in) provided by financing activities | (367,620) | 13,381,258 |
Effect of exchange rate changes on cash and cash equivalents | (8,606) | (21,487) |
Net (decrease) increase in cash and cash equivalents | (10,244,478) | 3,621,167 |
Cash and cash equivalents, at beginning of period | 45,951,233 | 20,354,462 |
Cash and cash equivalents, at end of period | 35,706,755 | 23,975,629 |
Supplemental disclosure for cash flow information: | ||
Interest | 8,045 | 3,741 |
Income taxes | 1,500 | |
Noncash investing and financing transactions: | ||
Increase in right-of-use assets and operating lease liabilities resulting from contract modification | 388,372 | |
Amounts accrued for offering costs | $ 31,415 |
Nature of Operations and Basis
Nature of Operations and Basis of Presentation | 3 Months Ended |
Oct. 31, 2021 | |
Organization, Consolidation and Presentation of Financial Statements [Abstract] | |
Nature of Operations and Basis of Presentation | Note 1— Nature of Operations and Basis of Presentation OncoSec Medical Incorporated (together with its subsidiary, unless the context indicates otherwise, being collectively referred to as the “Company”) began its operations as a biotechnology company in March 2011. The Company has not generated any revenues since its inception. The Company was incorporated in the State of Nevada on February 8, 2008 under the name of Netventory Solutions, Inc. and changed its name in March 2011 when it began operating as a biotechnology company. The Company is a late-stage immuno-oncology company focused on designing, developing and commercializing innovative, proprietary, intra-tumoral DNA-based therapeutics to stimulate and to augment anti-tumor immune responses for the treatment of cancers. Its core technology platform ImmunoPulse® is a drug-device therapeutic modality platform comprised of proprietary intratumoral electroporation (“EP”) delivery devices (the “OncoSec Medical System (“OMS”) Electroporation Device” or “OMS EP Device”) and a proprietary DNA plasmid that triggers transient expression of target protein in cells. The OMS EP Device is designed to deliver plasmid DNA-encoded drugs directly into a solid tumor and promote an immunological response against cancer. The OMS EP Device can be adapted to treat different tumor types, and consists of an electrical pulse generator, and disposable applicators. The Company’s lead product candidate is a DNA-encoded interleukin-12 (“IL-12”) called tavokinogene telseplasmid (“TAVO”). The OMS EP Device is used to deliver TAVO intratumorally, with the aim of reversing the immunosuppressive microenvironment in the treated tumor and elicit systemic tumor-specific immune responses in cancer patients. The activation of the appropriate inflammatory response in the treated tumor can drive a systemic anti-tumor response against untreated tumors in other parts of the body. In 2017, the Company received Fast Track Designation and Orphan Drug Designation from the U.S. Food and Drug Administration for TAVO in metastatic melanoma, which could qualify TAVO for expedited FDA review, a rolling Biologics License Application review and certain other benefits. The Company’s primary focus is to pursue its study of TAVO in combination with KEYTRUDA® (pembrolizumab) in melanoma and triple negative breast cancer (“TNBC”). The Company’s KEYNOTE-695 study is a registration-directed, Phase 2b open-label, single-arm, multicenter study in approximately 100 patients treated with TAVO in combination with KEYTRUDA® (pembrolizumab) in anti-PD-1 checkpoint (nivolumab or pembrolizumab) relapsed or refractory metastatic melanoma, being conducted in the United States, Canada, Australia and Europe. In May 2017, the Company entered into a clinical trial collaboration and supply agreement with a subsidiary of Merck in connection with the KEYNOTE-695 study. Pursuant to the terms of the agreement, both companies will bear their own costs related to manufacturing and supply of their product, as well as be responsible for their own internal costs. The Company is the study sponsor and is responsible for external costs. The study completed enrollment of the primary cohort in December 2020. In December 2020, the protocol was amended to include an additional cohort, consisting of patients who progressed on prior treatment of both ipilimumab and nivolumab. The amendment also enabled enrollment of approximately 25 additional patients to be treated with an updated version of the OMS EP Device (i.e., GenPulse generator and Series 3 Applicator), in preparation for FDA clearance. Based on and subject to the outcome of the study and feedback from FDA, the Company plans to file for accelerated approval with the FDA for this patient population in the second half of 2022. The Company’s KEYNOTE-890 study is a Phase 2, open-label, single-arm, multicenter study conducted in the United States and Australia to evaluate in patients with inoperable locally advanced or metastatic TNBC the safety and efficacy of TAVO in combination with KEYTRUDA® in patient who have previously failed at least one systemic chemotherapy or immunotherapy (Cohort 1) or the safety and efficacy of TAVO in combination with KEYTRUDA® and chemotherapy in patients with no prior systemic therapy (Cohort 2). In May 2018, the Company entered into a second clinical trial collaboration and supply agreement with Merck with respect to the KEYNOTE-890 study, Cohort 1. Pursuant to the terms of the agreement, both companies will bear their own costs related to manufacturing and supply of their product, as well as be responsible for their own internal costs. The Company is the study sponsor and is responsible for external costs. In June 2020, the Company amended its second clinical trial collaboration and supply agreement with Merck to include KEYNOTE-890, Cohort 2. Pursuant to the terms of the amended agreement, both companies will bear their own costs related to the manufacture and supply of their product, as well as be responsible for their own internal costs. The Company is the study sponsor and is responsible for external costs. Enrollment of Cohort 1 was completed (26 patients) in December 2020. Interim data for Cohort 1 was initially presented at the San Antonio Breast Cancer Symposium (“SABCS”) in December 2019, and an update on this cohort is was presented at the SABCS in December 2021. Enrollment of Cohort 2 (target 40 patients) began in January 2021 and is expected to be completed in 2022. In May 2019, the Company supported commencement of an investigator-initiated Phase 1 clinical trial conducted by the University of California San Francisco (“UCSF”) Helen Diller Family Comprehensive Cancer Center (“OMS-131”). This study targets patients with Squamous Cell Carcinoma of the Head & Neck and is a single-arm open-label clinical trial in which 68 evaluable patients will receive TAVO, KEYTRUDA® and epacadostat. Recruitment on this study has been halted after the last patient was treated in June 2021 while the Company and UCSF consider alterations in the design of the study. In August 2020, the Company supported commencement of an investigator-initiated Phase 2 study conducted by the H. Lee Moffitt Cancer Center and Research Institute and the University of South Florida Morsani College of Medicine to evaluate TAVO™ as neoadjuvant treatment (administered before surgery) in combination with intravenous OPDIVO®(nivolumab) in up to 33 patients with operable locally/regionally advanced melanoma. This study has been designed to evaluate whether the addition of TAVO can increase the published anti-tumor response observed with monotherapy OPDIVO®, an anti-PD-1 checkpoint inhibitor, in patients with locally/regionally advanced melanoma prior to surgical resection of tumors. This study began enrolling patients in December of 2020 and is expected to complete enrollment in 2022. In November 2020, the Company obtained exclusively licensed rights to the Cliniporator® electroporation gene electrotransfer platform from IGEA Clinical Biophysics. This platform has been used for electrochemotherapy in and outside of Europe in over 200 major oncological centers to treat cutaneous metastatic cancer nodules, including melanoma. The license encompasses a broad field of use for gene delivery in oncology, including use as part of the Company’s visceral lesion applicator (“VLA”) program. In April 2020, the Company announced that Providence Cancer Institute, a part of Providence St. Joseph Health (“Providence”), was pursuing a first-in-human Phase 1 clinical trial of OncoSec’s novel DNA-encodable, investigational vaccine, CORVax12, which is designed to act as a prophylactic vaccine to prevent COVID-19. CORVax12 consists of the Company’s existing product candidate, TAVO™, in combination with an immunogenic component of the SARS-CoV-2 virus developed by researchers at the National Institutes of Health National Institute of Allergy and Infectious Diseases (“NIAID”). Providence investigators filed and received an Investigator-Initiated Investigational New Drug (“IND”) Application; however, at this time, Providence does not intend to continue further enrollment in this study. In April 2021, the Company announced that it has received authorization to CE mark the OMS (OncoSec Medical System) EP (Electroporation) Device for use in solid tumors. The CE-marked OMS includes GenPulse TM In July 2021, the Company entered into a clinical trial collaboration and supply agreement with Merck with respect to a Phase 3 study of TAVO TM ® The Company intends to continue to pursue potential new trials and studies related to TAVO, in various tumor types. In addition, the Company is also developing its next-generation EP device and applicator, including advancements toward prototypes, pursuing discovery research to identify other product candidates that, in addition to IL-12, can be encoded into propriety plasmid-DNA and delivered intratumorally using EP. Specifically, the Company is developing, propriety technology to potentially treat liver, lung, bladder, pancreatic and other difficult to treat visceral lesions through the direct delivery of plasmid-based IL-12 with the VLA. The VLA is being designed to work with low voltage EP generators, including but not limited to the Company’s proprietary APOLLO TM ® The Company established a collaboration with Emerge Health Pty (“Emerge”), the leading Australian company providing full registration, reimbursement, sales, marketing and distribution services of therapeutic products in Australia and New Zealand, to commercialize TAVO and make it available under Australia’s Special Access Scheme (“SAS”). Emerge was acquired in late 2019 and in June 2021 informed the Company that oncology will not be a core therapeutic focus for Emerge into the future. The collaboration was terminated effective October 1, 2021, and the Company will not continue to participate in the SAS program. Unaudited Interim Financial Information The accompanying unaudited condensed consolidated financial statements of the Company have been prepared in accordance with U.S. generally accepted accounting principles (“U.S. GAAP”) for interim financial information and with instructions to Form 10-Q and Article 8 of Regulation S-X. Accordingly, they do not include all the information and footnotes required by U.S. GAAP for complete financial statements. The condensed consolidated balance sheet as of October 31, 2021, the condensed consolidated statements of operations, the condensed consolidated statements of comprehensive loss, the condensed consolidated statements of stockholders’ equity and the condensed consolidated statements of cash flows for the three months ended October 31, 2021 and 2020, are unaudited, but include all adjustments (consisting of normal recurring adjustments) that the Company considers necessary for a fair presentation of the Company’s financial position, results of operations and cash flows for the periods presented. The condensed consolidated results of operations for the three months ended October 31, 2021 shown herein are not necessarily indicative of the consolidated results that may be expected for the year ending July 31, 2022, or for any other period. These condensed consolidated financial statements, and notes thereto, should be read in conjunction with the audited consolidated financial statements for the fiscal year ended July 31, 2021, included in the Company’s Annual Report on Form 10-K (the “Annual Report”) filed with the U.S. Securities and Exchange Commission (“SEC”) on October 29, 2021. The condensed consolidated balance sheet at July 31, 2021 has been derived from the audited financial statements at that date but does not include all the information and footnotes required by U.S. GAAP for complete financial statements. |
Significant Accounting Policies
Significant Accounting Policies | 3 Months Ended |
Oct. 31, 2021 | |
Accounting Policies [Abstract] | |
Significant Accounting Policies | Note 2— Significant Accounting Policies Principles of Consolidation The accompanying condensed consolidated financial statements include the accounts of the Company and its wholly-owned subsidiary, OncoSec Medical Australia PTY LTD. All significant intercompany accounts and transactions have been eliminated in consolidation. Use of Estimates The accompanying condensed consolidated financial statements have been prepared in conformity with generally accepted accounting principles in the United States of America (“U.S. GAAP”), which requires management to make estimates and assumptions that affect the reported amounts of assets and liabilities and disclosure of contingent liabilities at the date of the financial statements and the reported amounts of expenses during the reporting period. Such estimates include going concern, stock-based compensation, the accrual of research, product development and clinical obligations, impairment of long-lived assets, determining the Incremental Borrowing Rate for calculating Right-Of-Use (“ROU”) assets and lease liabilities and accounting for income taxes, including the related valuation allowance on the deferred tax asset and uncertain tax positions. The Company bases its estimates on historical experience and on various other assumptions that it believes are reasonable under the circumstances, the results of which form the basis for making judgments about the carrying values of assets and liabilities that are not readily apparent from other sources. On an ongoing basis, the Company reviews its estimates to ensure that they appropriately reflect changes in the business or as new information becomes available. Actual results may differ from these estimates. Segment Reporting The Company operates in a single industry segment—the discovery and development of novel immunotherapeutic product candidates to improve treatment options for patients and physicians, intended to treat a wide range of oncology indications. Cash and Cash Equivalents The Company considers all highly liquid investments that are readily convertible into cash and have an original maturity of three months or less at the time of purchase to be cash equivalents. Concentrations and Credit Risk The Company maintains cash balances at a small number of financial institutions in both the United States and Australia and such balances commonly exceed the $ 250,000 250,000 183,000 Property and Equipment The Company’s capitalization threshold is $ 5,000 Schedule of Useful Lives of Property and Equipment for Purpose of Computing Depreciation Computers and equipment: 3 10 Computer software: 1 3 Leasehold improvements: Shorter of lease period or useful life Construction-in-progress is stated at cost, which relates to the cost of equipment not yet placed into service. No depreciation expense is recorded on construction-in-progress until such time as the relevant assets are completed and put into use. Intangible Assets Definite life intangible assets include a license. Intangible assets are recorded at cost. License agreements cost represent the fair value of the license agreement on the date acquired. Intangible assets are amortized on a straight-line basis over their estimated useful life. Impairment of Long-Lived Assets The Company periodically assesses the carrying value of intangible and other long-lived assets, and whenever events or changes in circumstances indicate that the carrying amount of an asset might not be recoverable. The assets are considered to be impaired if the Company determines that the carrying value may not be recoverable based upon its assessment, which includes consideration of the following events or changes in circumstances: ● the asset’s ability to continue to generate income from operations and positive cash flow in future periods; ● loss of legal ownership or title to the asset(s); ● significant changes in the Company’s strategic business objectives and utilization of the asset(s); and ● the impact of significant negative industry or economic trends. If the assets are considered to be impaired, the impairment recognized is the amount by which the carrying value of the assets exceeds the fair value of the assets. Fair value is determined by the application of discounted cash flow models to project cash flows from the assets. In addition, the Company bases estimates of the useful lives and related amortization or depreciation expense on its subjective estimate of the period the assets will generate revenue or otherwise be used by it. Assets to be disposed of are reported at the lower of the carrying amount or fair value, less selling costs. The Company also periodically reviews the lives assigned to long-lived assets to ensure that the initial estimates do not exceed any revised estimated periods from which the Company expects to realize cash flows from its assets. Research and Development Expenses Research and development expenses consist of costs incurred for internal projects, as well as partner-funded collaborative research and development activities. These costs include direct and research-related overhead expenses, which include salaries, stock-based compensation and other personnel-related expenses, facility costs, supplies, depreciation of facilities and laboratory equipment, as well as research consultants and the cost of funding research at universities and other research institutions, and are expensed as incurred. Costs to acquire technologies that are utilized in research and development that have no alternative future use, are expensed when incurred. In accordance with ASC 730-20, the Company accounts for upfront, non-refundable research and development payments received from a related party as a long-term liability as there has not been a substantive and genuine transfer of risk and there is a presumption that the Company is obligated to repay the related party. Accruals for Research and Development Expenses and Clinical Trials The Company is required to estimate its expenses resulting from its obligations under contracts with vendors, clinical research organizations and consultants and under clinical site agreements in connection with conducting clinical trials. The financial terms of these contracts vary from contract to contract and may result in payment terms that do not match the periods over which materials or services are provided under such contracts. The Company accounts for these expenses in its financial statements by matching those expenses with the period in which services are performed and efforts are expended. The Company determines accrual estimates through financial models and takes into account discussion with applicable personnel and outside service providers as to the progress of clinical trials, or the services completed. The Company makes estimates of its accrued expenses as of each balance sheet date based on the facts and circumstances known to it at that time. The Company’s clinical trial accruals are dependent upon the timely and accurate reporting of contract research organizations and other third-party vendors. During the course of a clinical trial, the Company adjusts its clinical expense recognition if actual results differ from its estimates. Fair Value of Financial Instruments The carrying amounts for cash and cash equivalents, prepaid expenses, accounts payable and accrued expenses and notes payable approximate fair value due to the short-term nature of these instruments. It is management’s opinion that the Company is not exposed to significant interest, currency, or credit risks arising from its other financial instruments and that their fair values approximate their carrying values except where expressly disclosed. The accounting standard for fair value measurements provides a framework for measuring fair value and requires disclosures regarding fair value measurements. Fair value is defined as the price that would be received to sell an asset or paid to transfer a liability in an orderly transaction between market participants at the measurement date, based on the Company’s principal or, in the absence of a principal, most advantageous market for the specific asset or liability. The Company uses a three-tier fair value hierarchy to classify and disclose all assets and liabilities measured at fair value on a recurring basis, as well as assets and liabilities measured at fair value on a non-recurring basis, in periods subsequent to their initial measurement. The hierarchy requires the Company to use observable inputs when available, and to minimize the use of unobservable inputs, when determining fair value. The three tiers are defined as follows: ● Level 1—Observable inputs that reflect quoted market prices (unadjusted) for identical assets or liabilities in active markets at the measurement date. Since valuations are based on quoted prices that are readily and regularly available in an active market, valuation of these products does not entail a significant degree of judgment. ● Level 2—Observable inputs other than quoted prices in active markets that are observable either directly or indirectly in the marketplace for identical or similar assets and liabilities. ● Level 3—Valuations based on inputs that are unobservable and significant to the overall fair value measurement. The development and determination of the unobservable inputs for Level 3 fair value measurements and fair value calculations are the responsibility of the Company’s management. Changes in fair value measurements categorized within Level 3 of the fair value hierarchy are analyzed each period based on changes in estimates or assumptions and recorded as appropriate. The Company had no assets or liabilities that required remeasurement on a recurring basis as of October 31, 2021 and July 31, 2021. Warrants The Company assesses its warrants as either equity or a liability based upon the characteristics and provisions of each instrument. Warrants classified as equity are recorded at fair value as of the date of issuance on the Company’s balance sheet and no further adjustments to their valuation are made. Warrants classified as derivative liabilities and other derivative financial instruments that require separate accounting as liabilities are recorded on the Company’s balance sheet at their fair value on the date of issuance and are re-measured on each subsequent balance sheet date until such instruments are exercised or expire, with any changes in the fair value between reporting periods recorded as other income or expense. Management estimates the fair value of these liabilities using option pricing models and assumptions that are based on the individual characteristics of the warrants or other instruments on the valuation date, as well as assumptions for future financings, expected volatility, expected life, yield and risk-free interest rate. As of October 31, 2021 and July 31, 2021, all outstanding warrants issued by the Company were classified as equity. Net Loss Per Share The Company computes basic net loss per common share by dividing the applicable net loss by the weighted-average number of common shares outstanding during the period. Diluted earnings per share is computed by dividing the applicable net loss by the weighted-average number of common shares outstanding during the period plus additional shares to account for the dilutive effect of potential future issuances of common stock relating to stock options and other potentially dilutive securities using the treasury stock method. The Company did not include shares underlying stock options, restricted stock units and warrants issued and outstanding during any of the periods presented in the computation of net loss per share, as the effect would have been anti-dilutive. The following potentially dilutive outstanding securities were excluded from diluted net loss per share because of their anti-dilutive effect: Schedule of Antidilutive Securities Excluded from Computation of Earnings Per Share For the Three Months Ended October 31, 2021 For the Three Months Ended October 31, 2020 Stock options 2,852,425 2,520,639 Restricted stock units 105,164 25,873 Warrants 1,706,190 3,114,288 Total 4,663,779 5,660,800 Stock-Based Compensation The Company grants equity-based awards (typically stock options or restricted stock units) under its stock-based compensation plan and outside of its stock-based compensation plan, with terms generally similar to the terms under the Company’s stock-based compensation plan. The Company estimates the fair value of stock option awards using the Black-Scholes option valuation model. For employees, directors and consultants, the fair value of the award is measured on the grant date. The fair value amount is then recognized over the period during which services are required to be provided in exchange for the award, usually the vesting period. The Black-Scholes option valuation model requires the input of subjective assumptions, including price volatility of the underlying stock, risk-free interest rate, dividend yield, and expected life of the option. The Company estimates the fair value of restricted stock unit awards based on the closing price of the Company’s common stock on the date of issuance. Employee Stock Purchase Plan Employees may elect to participate in the Company’s stockholder-approved employee stock purchase plan. The stock purchase plan allows for the purchase of the Company’s common stock at not less than 85 In accordance with applicable accounting guidance, the fair value of awards under the stock purchase plan is calculated at the beginning of each offering period. The Company estimates the fair value of the awards using the Black-Scholes option valuation model. The Black-Scholes option valuation model requires the input of subjective assumptions, including price volatility of the underlying stock, risk-free interest rate, dividend yield, and the offering period. This fair value is then amortized at the beginning of the offering period. Stock-based compensation expense is based on awards expected to be purchased at the beginning of the offering period, and therefore is reduced when participants withdraw during the offering period. Leases The Company determines if an arrangement is a lease at inception. Operating lease ROU assets represent the Company’s right to use an underlying asset during the lease term, and operating lease liabilities represent the Company’s obligation to make lease payments arising from the lease. Operating leases are included in ROU assets, current operating lease liabilities, and long-term operating lease liabilities on the Company’s condensed consolidated balance sheets. Lease ROU assets and lease liabilities are initially recognized based on the present value of the future minimum lease payments over the lease term at commencement date calculated using the Company’s incremental borrowing rate applicable to the lease asset, unless the implicit rate is readily determinable. ROU assets also include any lease payments made at or before lease commencement and exclude any lease incentives received. The Company’s lease terms may include options to extend or terminate the lease when it is reasonably certain that the Company will exercise that option. Leases with a term of 12 Foreign Currency Translation The Company uses the U.S. Dollar as the reporting currency for its financial statements. Functional currency is the currency of the primary economic environment in which an entity operates. The functional currency of the Company’s wholly owned subsidiary is the Australian dollar. Assets and liabilities of the Company’s subsidiary are translated into U.S. Dollars at period-end foreign exchange rates, and revenues and expenses are translated at average rates prevailing throughout the period. Translation adjustments are included in “Accumulated other comprehensive income” as a separate component of stockholders’ equity, and in the “Effect of exchange rate changes on cash and cash equivalents,” on the Company’s condensed consolidated statements of cash flows. Transaction gains and losses including intercompany transactions denominated in a currency other than the functional currency of the entity involved are included in “Foreign currency exchange gain (loss), net” on the Company’s condensed consolidated statements of operations. Accumulated Other Comprehensive Income (Loss) Accumulated other comprehensive income (loss) includes foreign currency translation adjustments related to the Company’s subsidiary in Australia and is excluded from the accompanying condensed consolidated statements of operations. Australia Research and Development Tax Credit The Company’s wholly-owned Australian subsidiary incurs research and development expenses, primarily in the course of conducting clinical trials. The Company’s Australian research and development activities qualify for the Australian government’s tax credit program, which provides a 43.5 Tax Reform On March 27, 2020, the president signed into law the Coronavirus Aid, Relief and Economic Security Act (“CARES Act”) providing nearly $ 2 Recent Accounting Pronouncements No recent accounting pronouncements are anticipated to have an impact on or related to the Company’s financial condition, results of operations, or related disclosures. |
Going Concern and Management_s
Going Concern and Management’s Plans | 3 Months Ended |
Oct. 31, 2021 | |
Organization, Consolidation and Presentation of Financial Statements [Abstract] | |
Going Concern and Management’s Plans | Note 3— Going Concern and Management’s Plans The Company has sustained losses in all reporting periods since inception, with an accumulated deficit of approximately $ 262 million as of October 31, 2021. These losses are expected to continue for an extended period of time. Further, the Company has never generated any cash from its operations and does not expect to generate such cash in the near term. The aforementioned factors raise substantial doubt about the Company’s ability to continue as a going concern within one year from the issuance date of the condensed consolidated financial statements. The accompanying condensed consolidated 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 condensed consolidated 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 condensed consolidated financial statements are issued. As of December 13, 2021, the Company had cash and cash equivalents of $ 30.2 The Company recognizes it will need to raise additional capital to continue operating its business and fund its planned operations, including research and development, clinical trials and, if regulatory approval is obtained, commercialization of its product candidates. In addition, the Company will require additional financing if it desires to in-license or acquire new assets, research and develop new compounds or new technologies and pursue related patent protection, or obtain any other intellectual property rights or other assets. There is no assurance that additional financing will be available to the Company when needed, 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. The source, timing and availability of any future financing will depend principally upon market conditions, and, more specifically, on the progress of our clinical development programs. The ongoing COVID-19 pandemic has also caused volatility in the global financial markets and threatened a slowdown in the global economy, which may negatively affect our ability to raise additional capital on attractive terms or at all. If the Company is unable to raise sufficient additional funds when needed, on favorable terms or at all, the Company will not be able to continue the development of its product candidates as currently planned or at all, will need to reevaluate its planned operations and may need to delay, scale back or eliminate some or all of its development programs, reduce expenses or cease operations, any of which would have a significant negative impact on its prospects and financial condition. |
Balance Sheet Details
Balance Sheet Details | 3 Months Ended |
Oct. 31, 2021 | |
Organization, Consolidation and Presentation of Financial Statements [Abstract] | |
Balance Sheet Details | Note 4— Balance Sheet Details Property and Equipment Property and equipment, net, is comprised of the following: Schedule of Property and Equipment, Net October 31, 2021 July 31, 2021 Equipment and furniture $ 1,911,641 $ 1,919,301 Computer software 109,242 109,242 Leasehold improvements 32,651 32,651 Construction in progress 234,409 234,409 Property and equipment, gross 2,287,943 2,295,603 Accumulated depreciation and amortization (1,413,307 ) (1,366,782 ) Total $ 874,636 $ 928,821 Depreciation and amortization expense recorded for the three months ended October 31, 2021 and 2020 was approximately $ 47,000 50,000 Intangible Assets Intangible assets, net, is comprised of the following: Schedule of Intangible Assets October 31, 2021 July 31, 2021 License $ 495,000 $ 495,000 Accumulated amortization (64,059 ) (46,588 ) Total $ 430,941 $ 448,412 In November 2020, the Company licensed generator technology for use in its clinical trials and other research and development efforts. Unless earlier terminated, the term of the license agreement will remain in effect for 85 months. The Company has determined that the license has alternative future uses in research and development projects. The value of the acquired license is recorded as an intangible asset with amortization over the estimated useful life of 85 Intangible asset amortization expense recorded for the three months ended October 31, 2021 and 2020 was approximately $ 17,000 0 At October 31, 2021, the estimated amortization expense by fiscal year based on the current carrying value of intangible assets is as follows: Schedule of Amortization Expense of Intangible Assets oct 31 2021 Years ending July 31, 2022– the remainder of the fiscal year $ 52,412 2023 69,882 2024 69,882 2025 69,882 2026 69,882 Thereafter 99,001 Total $ 430,941 Accounts Payable and Accrued Liabilities Accounts payable and accrued liabilities are comprised of the following: Schedule of Accounts Payable and Accrued Liabilities October 31, 2021 July 31, 2021 Research and development costs $ 3,032,542 $ 4,206,926 Professional services fees 1,411,141 1,229,040 Other 69,852 125,679 Total $ 4,513,535 $ 5,561,645 Accrued Compensation Accrued compensation is comprised of the following: Schedule of Accrued Compensation October 31, 2021 July 31, 2021 Accrued payroll $ 105,331 $ 311,590 401K payable 31,933 9,065 Accrued Severance 350,104 - Total $ 487,368 $ 320,655 |
Notes Payable
Notes Payable | 3 Months Ended |
Oct. 31, 2021 | |
Debt Disclosure [Abstract] | |
Notes Payable | Note 5— Notes Payable On July 1, 2021, the Company entered into a finance agreement with AFCO Premium Credit LLC (“AFCO”). Pursuant to the terms of the agreement, AFCO loaned the Company the principal amount of $ 1,355,919 2.894 eleven monthly payments 125,056 867,009 |
Stockholders_ Equity
Stockholders’ Equity | 3 Months Ended |
Oct. 31, 2021 | |
Equity [Abstract] | |
Stockholders’ Equity | Note 6— Stockholders’ Equity August 2020 Offering On August 19, 2020, the Company completed the offer and sale of an aggregate of 4,608,589 3.25 15.0 13.5 8.0% 0.3 Outstanding Warrants At October 31, 2021, the Company had outstanding warrants to purchase 1,706,190 3.45 16.80 China Grand Pharmaceutical and Healthcare Holdings Limited and Sirtex Medical US Holdings, Inc. On October 10, 2019, the Company and China Grand Pharmaceutical and Healthcare Holdings Limited, a company formed under the laws of the British Virgin Islands (“CGP”), and its affiliate, Sirtex Medical US Holdings, Inc., a Delaware corporation (“Sirtex”) entered into Stock Purchase Agreements (as amended, the “Purchase Agreements”). Pursuant to which CGP and Sirtex were given the right to purchase additional shares of common stock at a purchase price equal to the same exercise price paid by each warrant holder in order to maintain CGP and Sirtex’s respective ownership percentages of the outstanding shares of common stock of the Company as of October 10, 2019. |
Stock-Based Compensation
Stock-Based Compensation | 3 Months Ended |
Oct. 31, 2021 | |
Share-based Payment Arrangement [Abstract] | |
Stock-Based Compensation | Note 7— Stock-Based Compensation The OncoSec Medical Incorporated 2011 Stock Incentive Plan (as amended and approved by the Company’s stockholders (the “2011 Plan”)), authorizes the Company’s Board of Directors to grant equity awards, including stock options and restricted stock units, to employees, directors and consultants. The 2011 Plan authorizes a total of 4,600,000 100 10 110 Stock Options During the three months ended October 31, 2021, the Company granted options to purchase 23,400 10 2.01 2.26 During the three months ended October 31, 2020, the Company granted options to purchase 726,576 125,000 25,000 10 3.43 3.82 10 3.43 10 3.82 During the three months ended October 31, 2020, the Company granted options to purchase 300,000 10 3.56 The Company accounts for stock-based compensation based on the fair value of the stock-based awards granted 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. The service period is generally the vesting period, with the exception of stock options granted pursuant to a consulting agreement, in which case the stock option vesting period and the service period are defined pursuant to the terms of the consulting agreement. The following assumptions were used for the Black-Scholes calculation of the fair value of stock-based compensation related to stock options granted during the periods presented: Schedule of Assumptions used to Calculate Fair Value of Stock Based Compensation Three Months Ended October 31, 2021 Three Months Ended October 31, 2020 Expected term (years) 5.13 6.00 5.00 6.50 Risk-free interest rate 0.69 0.92 % 0.27 0.52 % Volatility 86.98 88.89 % 85.31 88.44 % Dividend yield 0 % 0 % The Company’s expected volatility is derived from the historical daily change in the market price of its common stock. The Company uses the simplified method to calculate the expected term of options issued to employees, non-employees and directors, as the Company does not have much stock option exercise history and thus does not have enough information on exercise behavior to calculate a refined expected term based on that information. The risk-free interest rate used in the Black-Scholes calculation is based on the prevailing U.S. Treasury yield in effect at the time of grant, commensurate with the expected term. For the expected dividend yield used in the Black-Scholes calculation, the Company has never paid any dividends on its common stock and does not anticipate paying dividends on its common stock in the foreseeable future. The following is a summary of the Company’s 2011 Plan and non-Plan stock option activity for the three months ended October 31, 2021: Summary of Stock Option Activity Options Weighted Average Exercise Price Weighted - average Remaining Contract Aggregate Intrinsic Value ($000) Outstanding - July 31, 2021 3,111,642 $ 3.27 Granted 23,400 $ 2.12 Forfeited/Cancelled (282,617 ) $ 4.70 Outstanding - October 31, 2021 2,852,425 $ 3.12 8.9 $ 92 Exercisable - October 31, 2021 2,083,160 $ 2.88 8.8 $ 88 The weighted-average grant date fair value of stock options granted during the three months ended October 31, 2021 and 2020 was $ 1.50 2.58 As of October 31, 2021, the Company has approximately $ 1.9 1.45 1.1 1.7 Stock-based compensation expense recorded in the Company’s condensed consolidated statements of operations for the three months ended October 31, 2021 resulting from stock options awarded to the Company’s employees, directors and consultants was approximately $ 0.5 million. Of the total expense, $ 0.3 million was recorded to research and development and $ 0.2 million was recorded in general and administrative in the Company’s condensed consolidated statements of operations for the three months ended October 31, 2021. Stock-based compensation expense recorded in the Company’s condensed consolidated statements of operations for the three months ended October 31, 2020 resulting from stock options awarded to the Company’s employees, directors and consultants was approximately $ 1.9 million. Of the total expense, $ 1.0 million was recorded to research and development and $ 0.9 million was recorded in general and administrative in the Company’s condensed consolidated statements of operations for the three months ended October 31, 2020. Restricted Stock Units (“RSUs”) For the three months ended October 31, 2021 and 2020, the Company recorded approximately $ 76,000 27,000 The following table summarize restricted stock units issued and outstanding: Summarize Restricted Stock Units RSUs Weighted Average Grant Date Fair Value Nonvested - July 31, 2021 442,749 $ 3.24 Vested (37,480 ) $ 3.29 Forfeited/Cancelled (300,105 ) $ 3.16 Nonvested - October 31, 2021 105,164 $ 3.44 As of October 31, 2021, there was approximately $ 0.3 1.6 Shares Issued to Consultants During the three months ended October 31, 2021 and 2020, 12,500 25,000 0.04 0.1 2015 Employee Stock Purchase Plan Under the Company’s 2015 Employee Stock Purchase Plan (“ESPP”), the Company is authorized to issue 50,000 29,794 The ESPP is considered a Type B plan under FASB ASC Topic 718 because the number of shares a participant is permitted to purchase is not fixed based on the stock price at the beginning of the offering period and the expected withholdings. The ESPP enables the participant to “buy-up” to the plan’s share limit, if the stock price is lower on the purchase date. As a result, the fair value of the awards granted under the ESPP is calculated at the beginning of each offering period as the sum of: ● 15 ● 85 ● 15 The fair market value of the six-month call and six-month put are based on the Black-Scholes option valuation model. For the six-month offering period to end on January 31, 2022, the following assumptions were used: six-month 0.05 72.99 0 0 six-month 0.1 122.84 0 0 Approximately $ 1,200 4,100 Common Stock Reserved for Future Issuance The following table summarizes all common stock reserved for future issuance at October 31, 2021: Summary of Common Stock Reserved for Future Issuance Oct312021 Common Stock options outstanding (within the 2011 Plan and outside of the terms of the 2011 Plan) 2,852,425 Common Stock reserved for restricted stock unit release 105,164 Common Stock authorized for future grant under the 2011 Plan 1,283,463 Common Stock reserved for warrant exercise 1,706,190 Shares issuable under CGP and Sirtex stock purchase agreements (See Note 6) 1,924,001 Common Stock reserved for future ESPP issuance 29,794 Total Common Stock reserved for future issuance 7,901,037 |
Commitments and Contingencies
Commitments and Contingencies | 3 Months Ended |
Oct. 31, 2021 | |
Commitments and Contingencies Disclosure [Abstract] | |
Commitments and Contingencies | Note 8— Commitments and Contingencies Contingencies The Company is not a party to any other legal proceeding or aware of any other threatened action as of the date of this report. Employment Agreements The Company has entered into employment agreements with certain executive officers and certain other key employees. Generally, the terms of these agreements provide that, if the Company terminates the officer or employee other than for cause, death or disability, or if the officer terminates his or her employment with the Company for good cause, the officer shall be entitled to receive certain severance compensation and benefits as described in each such agreement. On August 13, 2021, the Company and the former interim CEO entered into an agreement, providing for severance payments and benefits to the former interim CEO consistent with the terms of his existing offer letter with the Company, including a severance payment of $ 365,000 , less tax withholdings, and reimbursement of COBRA premiums (less the portion of the premium that he would have paid if he was an active employee), in each case payable for twelve months following his departure. Accrued severance of approximately $ 350,000 was included in Accrued compensation related on the condensed consolidated balance sheet as of October 31, 2021. |
Leases
Leases | 3 Months Ended |
Oct. 31, 2021 | |
Leases | |
Leases | Note 9— Leases Lease Agreements The Company has operating leases for corporate offices and lab space. These leases have remaining lease terms of approximately one year to seven years, some of which include options to extend the lease. For any lease where the Company is reasonably certain that a renewal option will be exercised, the lease payments associated with the renewal option period are included in the ROU asset and lease liability as of October 31, 2021. Supplemental balance sheet information related to leases as of October 31, 2021 was as follows: Schedule of Operating Lease Liabilities Operating Leases: Oct, 31, 2021 Operating lease right-of-use assets $ 5,350,864 Operating Leases: Current portion included in current liabilities $ 1,002,038 Long-term portion included in non-current liabilities 4,976,279 Total operating lease liabilities $ 5,978,317 Supplemental lease expense related to leases was as follows: Schedule of Lease Expenses For the Three Months Ended October 31, 2021 Operating lease cost $ 369,792 Total lease expense $ 369,792 Other information related to leases where the Company is the lessee is as follows: Schedule of Other Information Related to Leases As of October 31, 2021 Weighted-average remaining lease term 4.8 Weighted-average discount rate 9.96 % Supplemental cash flow information related to operating leases is as follows: Schedule of Cash Flow Information Related to Operating Leases For the Three Months Ended October 31, 2021 Cash paid for operating lease liabilities $ 380,284 Total cash flows related to operating lease liabilities $ 380,284 Future minimum lease payments under non-cancellable leases as of October 31, 2021 is as follows: Schedule of Future Minimum Lease Payments Under Non-Cancellable Lease Years ending July 31, Oct,31,2021 2022– the remainder of the fiscal year $ 1,162,716 2023 1,585,224 2024 1,539,142 2025 1,516,126 2026 1,533,882 Thereafter 240,688 Total minimum lease payments 7,577,778 Less: Imputed interest (1,599,461 ) Total $ 5,978,317 |
401(k) Plan
401(k) Plan | 3 Months Ended |
Oct. 31, 2021 | |
Retirement Benefits [Abstract] | |
401(k) Plan | Note 10— 401(k) Plan Effective May 15, 2012, the Company adopted a defined contribution savings plan pursuant to Section 401(k) of the Code. The plan is for the benefit of all qualifying employees and permits voluntary contributions by employees of up to 100 % of eligible compensation, subject to the maximum limits imposed by Internal Revenue Service. The terms of the plan allow for discretionary employer contributions and the Company currently matches 100 % of its employees’ contributions, up to 3 % of their annual compensation. The Company’s contributions are recorded as expense in the accompanying condensed consolidated statements of operations and totalled approximately $ 54,000 and $ 28,000 for the three months ended October 31, 2021 and 2020, respectively. |
Related Party Transactions
Related Party Transactions | 3 Months Ended |
Oct. 31, 2021 | |
Related Party Transactions [Abstract] | |
Related Party Transactions | Note 11— Related Party Transactions Except as disclosed elsewhere herein, below are the Company’s related party transactions. Equity Offerings On August 19, 2020, the Company completed the offer and sale of an aggregate of 4,608,589 3.25 Co-Promotion and Funded Research Agreement In January 2021, the Company entered into a co-promotion agreement with Sirtex, pursuant to which the Company granted Sirtex the option to co-promote TAVO for the treatment of anti-PD-1 refractory locally advanced or metastatic melanoma in the U.S., including its territories and possessions. In consideration for the option, the Company received an upfront, non-refundable payment of $ 5.0 25.0 20.0 5.0 Under the terms of the co-promotion agreement, if Sirtex exercises the co-promote option, the Company will pay to Sirtex a high-teens to low-twenties royalty (“promotion fee”) of U.S. net sales of the TAVO products. The co-promotion agreement will continue until the earlier of the expiration of the option period without Sirtex extending the option or the eighth anniversary of the first FDA approval of the BLA, and can be extended by mutual agreement between the Company and Sirtex. During the co-promotion term, the Company is responsible for funding approximately two-thirds of the promotional costs incurred by Sirtex and Sirtex shall be responsible for approximately one-third. The Company has determined that the co-promotion agreement represents a funded research and development arrangement within the scope of ASC Subtopic 730-20, Research and Development—Research and Development Arrangements (ASC 730-20). The Company concluded that there has not been a substantive and genuine transfer of risk related to the co-promotion agreement and the Company’s ongoing development of TAVO as there is a presumption that the Company is obligated to repay Sirtex based on the significant related party relationship that exists between the parties. This significant related party relationship is based on Sirtex’s approximate 8 % ownership of the outstanding shares of the Company’s common stock, and that of its significant equity holder, CGP (which owns 49 % of Sirtex), which, at the time of entering into the agreement, owned approximately 42 % of the outstanding shares of the Company’s common stock and is the Company’s largest shareholder. The Company has determined that the appropriate accounting treatment under ASC 730-20 is to record any proceeds received from Sirtex for the co-promote option or upon exercise of the option as cash and cash equivalents as the Company has the ability to direct the usage of funds, and as a corresponding long-term liability (“Liability under co-promotion agreement – related party”) on the Company’s condensed consolidated balance sheet when received. The liability will remain on the balance sheet until (i) Sirtex exercises the option which results in royalties paid by the Company to Sirtex based on the net sales of the TAVO products, or (ii) Sirtex does not exercise the option and the co-promotion agreement is terminated by the parties. As of October 31, 2021, the balance of the Liability under co-promotion agreement – related party relates to the option fee payment of $ 5.0 |
Subsequent Events
Subsequent Events | 3 Months Ended |
Oct. 31, 2021 | |
Subsequent Events [Abstract] | |
Subsequent Events | Note 12— Subsequent Events Except as disclosed elsewhere herein, below are the Company’s subsequent events. On November 29, 2021, the Company notified The Nasdaq Capital Market (“Nasdaq”) that Robert Ward, as previously disclosed on the Company’s Current Report filed on Form 8-K on November 30, 2021, had resigned as a member of the board of directors of the Company (the “Board”) and the Company’s Audit Committee. After giving effect to Mr. Ward’s resignation, the Company’s Audit Committee no longer consists of three independent members as required by Nasdaq Listing Rule 5605(c)(2)(A). On December 8, 2021, the Company received a letter from Nasdaq noting that the Company no longer complied with the requirement of Listing Rule 5605. The letter also acknowledged that the Listing Rules provide a cure period in order for the Company to regain compliance until the earlier of the Company’s next annual meeting of stockholders or November 23, 2022 (or, by May 23, 2022, if such meeting is held before May 23, 2022). The Company intends to cure this deficiency during the allotted period afforded to it by Nasdaq. |
Significant Accounting Polici_2
Significant Accounting Policies (Policies) | 3 Months Ended |
Oct. 31, 2021 | |
Accounting Policies [Abstract] | |
Principles of Consolidation | Principles of Consolidation The accompanying condensed consolidated financial statements include the accounts of the Company and its wholly-owned subsidiary, OncoSec Medical Australia PTY LTD. All significant intercompany accounts and transactions have been eliminated in consolidation. |
Use of Estimates | Use of Estimates The accompanying condensed consolidated financial statements have been prepared in conformity with generally accepted accounting principles in the United States of America (“U.S. GAAP”), which requires management to make estimates and assumptions that affect the reported amounts of assets and liabilities and disclosure of contingent liabilities at the date of the financial statements and the reported amounts of expenses during the reporting period. Such estimates include going concern, stock-based compensation, the accrual of research, product development and clinical obligations, impairment of long-lived assets, determining the Incremental Borrowing Rate for calculating Right-Of-Use (“ROU”) assets and lease liabilities and accounting for income taxes, including the related valuation allowance on the deferred tax asset and uncertain tax positions. The Company bases its estimates on historical experience and on various other assumptions that it believes are reasonable under the circumstances, the results of which form the basis for making judgments about the carrying values of assets and liabilities that are not readily apparent from other sources. On an ongoing basis, the Company reviews its estimates to ensure that they appropriately reflect changes in the business or as new information becomes available. Actual results may differ from these estimates. |
Segment Reporting | Segment Reporting The Company operates in a single industry segment—the discovery and development of novel immunotherapeutic product candidates to improve treatment options for patients and physicians, intended to treat a wide range of oncology indications. |
Cash and Cash Equivalents | Cash and Cash Equivalents The Company considers all highly liquid investments that are readily convertible into cash and have an original maturity of three months or less at the time of purchase to be cash equivalents. |
Concentrations and Credit Risk | Concentrations and Credit Risk The Company maintains cash balances at a small number of financial institutions in both the United States and Australia and such balances commonly exceed the $ 250,000 250,000 183,000 |
Property and Equipment | Property and Equipment The Company’s capitalization threshold is $ 5,000 Schedule of Useful Lives of Property and Equipment for Purpose of Computing Depreciation Computers and equipment: 3 10 Computer software: 1 3 Leasehold improvements: Shorter of lease period or useful life Construction-in-progress is stated at cost, which relates to the cost of equipment not yet placed into service. No depreciation expense is recorded on construction-in-progress until such time as the relevant assets are completed and put into use. |
Intangible Assets | Intangible Assets Definite life intangible assets include a license. Intangible assets are recorded at cost. License agreements cost represent the fair value of the license agreement on the date acquired. Intangible assets are amortized on a straight-line basis over their estimated useful life. |
Impairment of Long-Lived Assets | Impairment of Long-Lived Assets The Company periodically assesses the carrying value of intangible and other long-lived assets, and whenever events or changes in circumstances indicate that the carrying amount of an asset might not be recoverable. The assets are considered to be impaired if the Company determines that the carrying value may not be recoverable based upon its assessment, which includes consideration of the following events or changes in circumstances: ● the asset’s ability to continue to generate income from operations and positive cash flow in future periods; ● loss of legal ownership or title to the asset(s); ● significant changes in the Company’s strategic business objectives and utilization of the asset(s); and ● the impact of significant negative industry or economic trends. If the assets are considered to be impaired, the impairment recognized is the amount by which the carrying value of the assets exceeds the fair value of the assets. Fair value is determined by the application of discounted cash flow models to project cash flows from the assets. In addition, the Company bases estimates of the useful lives and related amortization or depreciation expense on its subjective estimate of the period the assets will generate revenue or otherwise be used by it. Assets to be disposed of are reported at the lower of the carrying amount or fair value, less selling costs. The Company also periodically reviews the lives assigned to long-lived assets to ensure that the initial estimates do not exceed any revised estimated periods from which the Company expects to realize cash flows from its assets. |
Research and Development Expenses | Research and Development Expenses Research and development expenses consist of costs incurred for internal projects, as well as partner-funded collaborative research and development activities. These costs include direct and research-related overhead expenses, which include salaries, stock-based compensation and other personnel-related expenses, facility costs, supplies, depreciation of facilities and laboratory equipment, as well as research consultants and the cost of funding research at universities and other research institutions, and are expensed as incurred. Costs to acquire technologies that are utilized in research and development that have no alternative future use, are expensed when incurred. In accordance with ASC 730-20, the Company accounts for upfront, non-refundable research and development payments received from a related party as a long-term liability as there has not been a substantive and genuine transfer of risk and there is a presumption that the Company is obligated to repay the related party. |
Accruals for Research and Development Expenses and Clinical Trials | Accruals for Research and Development Expenses and Clinical Trials The Company is required to estimate its expenses resulting from its obligations under contracts with vendors, clinical research organizations and consultants and under clinical site agreements in connection with conducting clinical trials. The financial terms of these contracts vary from contract to contract and may result in payment terms that do not match the periods over which materials or services are provided under such contracts. The Company accounts for these expenses in its financial statements by matching those expenses with the period in which services are performed and efforts are expended. The Company determines accrual estimates through financial models and takes into account discussion with applicable personnel and outside service providers as to the progress of clinical trials, or the services completed. The Company makes estimates of its accrued expenses as of each balance sheet date based on the facts and circumstances known to it at that time. The Company’s clinical trial accruals are dependent upon the timely and accurate reporting of contract research organizations and other third-party vendors. During the course of a clinical trial, the Company adjusts its clinical expense recognition if actual results differ from its estimates. |
Fair Value of Financial Instruments | Fair Value of Financial Instruments The carrying amounts for cash and cash equivalents, prepaid expenses, accounts payable and accrued expenses and notes payable approximate fair value due to the short-term nature of these instruments. It is management’s opinion that the Company is not exposed to significant interest, currency, or credit risks arising from its other financial instruments and that their fair values approximate their carrying values except where expressly disclosed. The accounting standard for fair value measurements provides a framework for measuring fair value and requires disclosures regarding fair value measurements. Fair value is defined as the price that would be received to sell an asset or paid to transfer a liability in an orderly transaction between market participants at the measurement date, based on the Company’s principal or, in the absence of a principal, most advantageous market for the specific asset or liability. The Company uses a three-tier fair value hierarchy to classify and disclose all assets and liabilities measured at fair value on a recurring basis, as well as assets and liabilities measured at fair value on a non-recurring basis, in periods subsequent to their initial measurement. The hierarchy requires the Company to use observable inputs when available, and to minimize the use of unobservable inputs, when determining fair value. The three tiers are defined as follows: ● Level 1—Observable inputs that reflect quoted market prices (unadjusted) for identical assets or liabilities in active markets at the measurement date. Since valuations are based on quoted prices that are readily and regularly available in an active market, valuation of these products does not entail a significant degree of judgment. ● Level 2—Observable inputs other than quoted prices in active markets that are observable either directly or indirectly in the marketplace for identical or similar assets and liabilities. ● Level 3—Valuations based on inputs that are unobservable and significant to the overall fair value measurement. The development and determination of the unobservable inputs for Level 3 fair value measurements and fair value calculations are the responsibility of the Company’s management. Changes in fair value measurements categorized within Level 3 of the fair value hierarchy are analyzed each period based on changes in estimates or assumptions and recorded as appropriate. The Company had no assets or liabilities that required remeasurement on a recurring basis as of October 31, 2021 and July 31, 2021. |
Warrants | Warrants The Company assesses its warrants as either equity or a liability based upon the characteristics and provisions of each instrument. Warrants classified as equity are recorded at fair value as of the date of issuance on the Company’s balance sheet and no further adjustments to their valuation are made. Warrants classified as derivative liabilities and other derivative financial instruments that require separate accounting as liabilities are recorded on the Company’s balance sheet at their fair value on the date of issuance and are re-measured on each subsequent balance sheet date until such instruments are exercised or expire, with any changes in the fair value between reporting periods recorded as other income or expense. Management estimates the fair value of these liabilities using option pricing models and assumptions that are based on the individual characteristics of the warrants or other instruments on the valuation date, as well as assumptions for future financings, expected volatility, expected life, yield and risk-free interest rate. As of October 31, 2021 and July 31, 2021, all outstanding warrants issued by the Company were classified as equity. |
Net Loss Per Share | Net Loss Per Share The Company computes basic net loss per common share by dividing the applicable net loss by the weighted-average number of common shares outstanding during the period. Diluted earnings per share is computed by dividing the applicable net loss by the weighted-average number of common shares outstanding during the period plus additional shares to account for the dilutive effect of potential future issuances of common stock relating to stock options and other potentially dilutive securities using the treasury stock method. The Company did not include shares underlying stock options, restricted stock units and warrants issued and outstanding during any of the periods presented in the computation of net loss per share, as the effect would have been anti-dilutive. The following potentially dilutive outstanding securities were excluded from diluted net loss per share because of their anti-dilutive effect: Schedule of Antidilutive Securities Excluded from Computation of Earnings Per Share For the Three Months Ended October 31, 2021 For the Three Months Ended October 31, 2020 Stock options 2,852,425 2,520,639 Restricted stock units 105,164 25,873 Warrants 1,706,190 3,114,288 Total 4,663,779 5,660,800 |
Stock-Based Compensation | Stock-Based Compensation The Company grants equity-based awards (typically stock options or restricted stock units) under its stock-based compensation plan and outside of its stock-based compensation plan, with terms generally similar to the terms under the Company’s stock-based compensation plan. The Company estimates the fair value of stock option awards using the Black-Scholes option valuation model. For employees, directors and consultants, the fair value of the award is measured on the grant date. The fair value amount is then recognized over the period during which services are required to be provided in exchange for the award, usually the vesting period. The Black-Scholes option valuation model requires the input of subjective assumptions, including price volatility of the underlying stock, risk-free interest rate, dividend yield, and expected life of the option. The Company estimates the fair value of restricted stock unit awards based on the closing price of the Company’s common stock on the date of issuance. |
Employee Stock Purchase Plan | Employee Stock Purchase Plan Employees may elect to participate in the Company’s stockholder-approved employee stock purchase plan. The stock purchase plan allows for the purchase of the Company’s common stock at not less than 85 In accordance with applicable accounting guidance, the fair value of awards under the stock purchase plan is calculated at the beginning of each offering period. The Company estimates the fair value of the awards using the Black-Scholes option valuation model. The Black-Scholes option valuation model requires the input of subjective assumptions, including price volatility of the underlying stock, risk-free interest rate, dividend yield, and the offering period. This fair value is then amortized at the beginning of the offering period. Stock-based compensation expense is based on awards expected to be purchased at the beginning of the offering period, and therefore is reduced when participants withdraw during the offering period. |
Leases | Leases The Company determines if an arrangement is a lease at inception. Operating lease ROU assets represent the Company’s right to use an underlying asset during the lease term, and operating lease liabilities represent the Company’s obligation to make lease payments arising from the lease. Operating leases are included in ROU assets, current operating lease liabilities, and long-term operating lease liabilities on the Company’s condensed consolidated balance sheets. Lease ROU assets and lease liabilities are initially recognized based on the present value of the future minimum lease payments over the lease term at commencement date calculated using the Company’s incremental borrowing rate applicable to the lease asset, unless the implicit rate is readily determinable. ROU assets also include any lease payments made at or before lease commencement and exclude any lease incentives received. The Company’s lease terms may include options to extend or terminate the lease when it is reasonably certain that the Company will exercise that option. Leases with a term of 12 |
Foreign Currency Translation | Foreign Currency Translation The Company uses the U.S. Dollar as the reporting currency for its financial statements. Functional currency is the currency of the primary economic environment in which an entity operates. The functional currency of the Company’s wholly owned subsidiary is the Australian dollar. Assets and liabilities of the Company’s subsidiary are translated into U.S. Dollars at period-end foreign exchange rates, and revenues and expenses are translated at average rates prevailing throughout the period. Translation adjustments are included in “Accumulated other comprehensive income” as a separate component of stockholders’ equity, and in the “Effect of exchange rate changes on cash and cash equivalents,” on the Company’s condensed consolidated statements of cash flows. Transaction gains and losses including intercompany transactions denominated in a currency other than the functional currency of the entity involved are included in “Foreign currency exchange gain (loss), net” on the Company’s condensed consolidated statements of operations. |
Accumulated Other Comprehensive Income (Loss) | Accumulated Other Comprehensive Income (Loss) Accumulated other comprehensive income (loss) includes foreign currency translation adjustments related to the Company’s subsidiary in Australia and is excluded from the accompanying condensed consolidated statements of operations. |
Australia Research and Development Tax Credit | Australia Research and Development Tax Credit The Company’s wholly-owned Australian subsidiary incurs research and development expenses, primarily in the course of conducting clinical trials. The Company’s Australian research and development activities qualify for the Australian government’s tax credit program, which provides a 43.5 |
Tax Reform | Tax Reform On March 27, 2020, the president signed into law the Coronavirus Aid, Relief and Economic Security Act (“CARES Act”) providing nearly $ 2 |
Recent Accounting Pronouncements | Recent Accounting Pronouncements No recent accounting pronouncements are anticipated to have an impact on or related to the Company’s financial condition, results of operations, or related disclosures. |
Significant Accounting Polici_3
Significant Accounting Policies (Tables) | 3 Months Ended |
Oct. 31, 2021 | |
Accounting Policies [Abstract] | |
Schedule of Useful Lives of Property and Equipment for Purpose of Computing Depreciation | Schedule of Useful Lives of Property and Equipment for Purpose of Computing Depreciation Computers and equipment: 3 10 Computer software: 1 3 Leasehold improvements: Shorter of lease period or useful life |
Schedule of Antidilutive Securities Excluded from Computation of Earnings Per Share | Schedule of Antidilutive Securities Excluded from Computation of Earnings Per Share For the Three Months Ended October 31, 2021 For the Three Months Ended October 31, 2020 Stock options 2,852,425 2,520,639 Restricted stock units 105,164 25,873 Warrants 1,706,190 3,114,288 Total 4,663,779 5,660,800 |
Balance Sheet Details (Tables)
Balance Sheet Details (Tables) | 3 Months Ended |
Oct. 31, 2021 | |
Organization, Consolidation and Presentation of Financial Statements [Abstract] | |
Schedule of Property and Equipment, Net | Property and equipment, net, is comprised of the following: Schedule of Property and Equipment, Net October 31, 2021 July 31, 2021 Equipment and furniture $ 1,911,641 $ 1,919,301 Computer software 109,242 109,242 Leasehold improvements 32,651 32,651 Construction in progress 234,409 234,409 Property and equipment, gross 2,287,943 2,295,603 Accumulated depreciation and amortization (1,413,307 ) (1,366,782 ) Total $ 874,636 $ 928,821 |
Schedule of Intangible Assets | Intangible assets, net, is comprised of the following: Schedule of Intangible Assets October 31, 2021 July 31, 2021 License $ 495,000 $ 495,000 Accumulated amortization (64,059 ) (46,588 ) Total $ 430,941 $ 448,412 |
Schedule of Amortization Expense of Intangible Assets | At October 31, 2021, the estimated amortization expense by fiscal year based on the current carrying value of intangible assets is as follows: Schedule of Amortization Expense of Intangible Assets oct 31 2021 Years ending July 31, 2022– the remainder of the fiscal year $ 52,412 2023 69,882 2024 69,882 2025 69,882 2026 69,882 Thereafter 99,001 Total $ 430,941 |
Schedule of Accounts Payable and Accrued Liabilities | Accounts payable and accrued liabilities are comprised of the following: Schedule of Accounts Payable and Accrued Liabilities October 31, 2021 July 31, 2021 Research and development costs $ 3,032,542 $ 4,206,926 Professional services fees 1,411,141 1,229,040 Other 69,852 125,679 Total $ 4,513,535 $ 5,561,645 |
Schedule of Accrued Compensation | Accrued compensation is comprised of the following: Schedule of Accrued Compensation October 31, 2021 July 31, 2021 Accrued payroll $ 105,331 $ 311,590 401K payable 31,933 9,065 Accrued Severance 350,104 - Total $ 487,368 $ 320,655 |
Stock-Based Compensation (Table
Stock-Based Compensation (Tables) | 3 Months Ended |
Oct. 31, 2021 | |
Share-based Payment Arrangement [Abstract] | |
Schedule of Assumptions used to Calculate Fair Value of Stock Based Compensation | The following assumptions were used for the Black-Scholes calculation of the fair value of stock-based compensation related to stock options granted during the periods presented: Schedule of Assumptions used to Calculate Fair Value of Stock Based Compensation Three Months Ended October 31, 2021 Three Months Ended October 31, 2020 Expected term (years) 5.13 6.00 5.00 6.50 Risk-free interest rate 0.69 0.92 % 0.27 0.52 % Volatility 86.98 88.89 % 85.31 88.44 % Dividend yield 0 % 0 % |
Summary of Stock Option Activity | The following is a summary of the Company’s 2011 Plan and non-Plan stock option activity for the three months ended October 31, 2021: Summary of Stock Option Activity Options Weighted Average Exercise Price Weighted - average Remaining Contract Aggregate Intrinsic Value ($000) Outstanding - July 31, 2021 3,111,642 $ 3.27 Granted 23,400 $ 2.12 Forfeited/Cancelled (282,617 ) $ 4.70 Outstanding - October 31, 2021 2,852,425 $ 3.12 8.9 $ 92 Exercisable - October 31, 2021 2,083,160 $ 2.88 8.8 $ 88 |
Summarize Restricted Stock Units | The following table summarize restricted stock units issued and outstanding: Summarize Restricted Stock Units RSUs Weighted Average Grant Date Fair Value Nonvested - July 31, 2021 442,749 $ 3.24 Vested (37,480 ) $ 3.29 Forfeited/Cancelled (300,105 ) $ 3.16 Nonvested - October 31, 2021 105,164 $ 3.44 |
Summary of Common Stock Reserved for Future Issuance | The following table summarizes all common stock reserved for future issuance at October 31, 2021: Summary of Common Stock Reserved for Future Issuance Oct312021 Common Stock options outstanding (within the 2011 Plan and outside of the terms of the 2011 Plan) 2,852,425 Common Stock reserved for restricted stock unit release 105,164 Common Stock authorized for future grant under the 2011 Plan 1,283,463 Common Stock reserved for warrant exercise 1,706,190 Shares issuable under CGP and Sirtex stock purchase agreements (See Note 6) 1,924,001 Common Stock reserved for future ESPP issuance 29,794 Total Common Stock reserved for future issuance 7,901,037 |
Leases (Tables)
Leases (Tables) | 3 Months Ended |
Oct. 31, 2021 | |
Leases | |
Schedule of Operating Lease Liabilities | Supplemental balance sheet information related to leases as of October 31, 2021 was as follows: Schedule of Operating Lease Liabilities Operating Leases: Oct, 31, 2021 Operating lease right-of-use assets $ 5,350,864 Operating Leases: Current portion included in current liabilities $ 1,002,038 Long-term portion included in non-current liabilities 4,976,279 Total operating lease liabilities $ 5,978,317 |
Schedule of Lease Expenses | Supplemental lease expense related to leases was as follows: Schedule of Lease Expenses For the Three Months Ended October 31, 2021 Operating lease cost $ 369,792 Total lease expense $ 369,792 |
Schedule of Other Information Related to Leases | Other information related to leases where the Company is the lessee is as follows: Schedule of Other Information Related to Leases As of October 31, 2021 Weighted-average remaining lease term 4.8 Weighted-average discount rate 9.96 % |
Schedule of Cash Flow Information Related to Operating Leases | Supplemental cash flow information related to operating leases is as follows: Schedule of Cash Flow Information Related to Operating Leases For the Three Months Ended October 31, 2021 Cash paid for operating lease liabilities $ 380,284 Total cash flows related to operating lease liabilities $ 380,284 |
Schedule of Future Minimum Lease Payments Under Non-Cancellable Lease | Future minimum lease payments under non-cancellable leases as of October 31, 2021 is as follows: Schedule of Future Minimum Lease Payments Under Non-Cancellable Lease Years ending July 31, Oct,31,2021 2022– the remainder of the fiscal year $ 1,162,716 2023 1,585,224 2024 1,539,142 2025 1,516,126 2026 1,533,882 Thereafter 240,688 Total minimum lease payments 7,577,778 Less: Imputed interest (1,599,461 ) Total $ 5,978,317 |
Schedule of Useful Lives of Pro
Schedule of Useful Lives of Property and Equipment for Purpose of Computing Depreciation (Details) | 3 Months Ended |
Oct. 31, 2021 | |
Computers And Equipment [Member] | Minimum [Member] | |
Property, Plant and Equipment [Line Items] | |
Property and equipment useful lives | 3 years |
Computers And Equipment [Member] | Maximum [Member] | |
Property, Plant and Equipment [Line Items] | |
Property and equipment useful lives | 10 years |
Software and Software Development Costs [Member] | Minimum [Member] | |
Property, Plant and Equipment [Line Items] | |
Property and equipment useful lives | 1 year |
Software and Software Development Costs [Member] | Maximum [Member] | |
Property, Plant and Equipment [Line Items] | |
Property and equipment useful lives | 3 years |
Leasehold Improvements [Member] | |
Property, Plant and Equipment [Line Items] | |
Property and equipment useful lives description | Shorter of lease period or useful life |
Schedule of Antidilutive Securi
Schedule of Antidilutive Securities Excluded from Computation of Earnings Per Share (Details) - shares | 3 Months Ended | |
Oct. 31, 2021 | Oct. 31, 2020 | |
Antidilutive Securities Excluded from Computation of Earnings Per Share [Line Items] | ||
Total | 4,663,779 | 5,660,800 |
Restricted Stock Units (RSUs) [Member] | ||
Antidilutive Securities Excluded from Computation of Earnings Per Share [Line Items] | ||
Total | 105,164 | 25,873 |
Stock Options [Member] | ||
Antidilutive Securities Excluded from Computation of Earnings Per Share [Line Items] | ||
Total | 2,852,425 | 2,520,639 |
Warrants [Member] | ||
Antidilutive Securities Excluded from Computation of Earnings Per Share [Line Items] | ||
Total | 1,706,190 | 3,114,288 |
Significant Accounting Polici_4
Significant Accounting Policies (Details Narrative) | Mar. 27, 2020USD ($) | Oct. 31, 2021USD ($) | Oct. 31, 2021AUD ($) |
Collaborative Arrangement and Arrangement Other than Collaborative [Line Items] | |||
Amount insured by federal deposit insurance corporation (FDIC) | $ 250,000 | ||
Amount issued insured australian financial claims | 183,000 | $ 250,000 | |
Capitalization threshold of property and equipment | $ 5,000 | ||
Percentage of stock purchase | 85.00% | ||
Lease term | 12 months | 12 months | |
Tax credit percentage | 43.50% | ||
Coronavirus Aid, Relief and Economic Security Act [Member] | |||
Collaborative Arrangement and Arrangement Other than Collaborative [Line Items] | |||
Economic relief to eligible businesses | $ 200,000,000,000 |
Schedule of Property and Equipm
Schedule of Property and Equipment, Net (Details) - USD ($) | Oct. 31, 2021 | Jul. 31, 2021 |
Property, Plant and Equipment [Line Items] | ||
Property and equipment, gross | $ 2,287,943 | $ 2,295,603 |
Accumulated depreciation and amortization | (1,413,307) | (1,366,782) |
Total | 874,636 | 928,821 |
Equipment and Furniture [Member] | ||
Property, Plant and Equipment [Line Items] | ||
Property and equipment, gross | 1,911,641 | 1,919,301 |
Software and Software Development Costs [Member] | ||
Property, Plant and Equipment [Line Items] | ||
Property and equipment, gross | 109,242 | 109,242 |
Leasehold Improvements [Member] | ||
Property, Plant and Equipment [Line Items] | ||
Property and equipment, gross | 32,651 | 32,651 |
Construction in Progress [Member] | ||
Property, Plant and Equipment [Line Items] | ||
Property and equipment, gross | $ 234,409 | $ 234,409 |
Going Concern and Management__2
Going Concern and Management’s Plans (Details Narrative) - USD ($) | Dec. 13, 2021 | Oct. 31, 2021 | Jul. 31, 2021 |
Subsequent Event [Line Items] | |||
Retained Earnings (Accumulated Deficit) | $ 261,586,656 | $ 251,778,031 | |
Cash and cash equivalents | $ 35,706,755 | $ 45,951,233 | |
Subsequent Event [Member] | |||
Subsequent Event [Line Items] | |||
Cash and cash equivalents | $ 30,200,000 |
Schedule of Intangible Assets (
Schedule of Intangible Assets (Details) - USD ($) | Oct. 31, 2021 | Jul. 31, 2021 |
Organization, Consolidation and Presentation of Financial Statements [Abstract] | ||
License | $ 495,000 | $ 495,000 |
Accumulated amortization | (64,059) | (46,588) |
Total | $ 430,941 | $ 448,412 |
Schedule of Amortization Expens
Schedule of Amortization Expense of Intangible Assets (Details) - USD ($) | Oct. 31, 2021 | Jul. 31, 2021 |
Organization, Consolidation and Presentation of Financial Statements [Abstract] | ||
2022– the remainder of the fiscal year | $ 52,412 | |
2023 | 69,882 | |
2024 | 69,882 | |
2025 | 69,882 | |
2026 | 69,882 | |
Thereafter | 99,001 | |
Total | $ 430,941 | $ 448,412 |
Schedule of Accounts Payable an
Schedule of Accounts Payable and Accrued Liabilities (Details) - USD ($) | Oct. 31, 2021 | Jul. 31, 2021 |
Organization, Consolidation and Presentation of Financial Statements [Abstract] | ||
Research and development costs | $ 3,032,542 | $ 4,206,926 |
Professional services fees | 1,411,141 | 1,229,040 |
Other | 69,852 | 125,679 |
Total | $ 4,513,535 | $ 5,561,645 |
Schedule of Accrued Compensatio
Schedule of Accrued Compensation (Details) - USD ($) | Oct. 31, 2021 | Jul. 31, 2021 |
Organization, Consolidation and Presentation of Financial Statements [Abstract] | ||
Accrued payroll | $ 105,331 | $ 311,590 |
401K payable | 31,933 | 9,065 |
Accrued Severance | 350,104 | |
Total | $ 487,368 | $ 320,655 |
Balance Sheet Details (Details
Balance Sheet Details (Details Narrative) - USD ($) | 1 Months Ended | 3 Months Ended | |
Nov. 30, 2020 | Oct. 31, 2021 | Oct. 31, 2020 | |
Organization, Consolidation and Presentation of Financial Statements [Abstract] | |||
Depreciation and amortization expense | $ 47,000 | $ 50,000 | |
Intangible asset estimated useful life | 85 months | ||
Intangible asset amortization expense | $ 17,000 | $ 0 |
Notes Payable (Details Narrativ
Notes Payable (Details Narrative) - Finance Agreement [Member] - AFCO Premium Credit LLC [Member] - USD ($) | Jul. 01, 2021 | Oct. 31, 2021 |
Collaborative Arrangement and Arrangement Other than Collaborative [Line Items] | ||
Debt principal amount | $ 1,355,919 | $ 867,009 |
Accrued interest rate | 2.894% | |
Number of monthly payments | eleven monthly payments | |
Monthly payments amount | $ 125,056 |
Stockholders_ Equity (Details N
Stockholders’ Equity (Details Narrative) - USD ($) $ / shares in Units, $ in Millions | Aug. 19, 2020 | Oct. 31, 2021 |
Accumulated Other Comprehensive Income (Loss) [Line Items] | ||
Sale of stock | 4,608,589 | |
Shares price, per share | $ 3.25 | |
Gross proceeds | $ 15 | |
Net proceeds | $ 13.5 | |
Cash fees percentage | 8.00% | |
Other expenses | $ 0.3 | |
Warrants [Member] | ||
Accumulated Other Comprehensive Income (Loss) [Line Items] | ||
Number of warrant to purchase shares of common stock | 1,706,190 | |
Warrants [Member] | Minimum [Member] | ||
Accumulated Other Comprehensive Income (Loss) [Line Items] | ||
Warrant exercise price per share | $ 3.45 | |
Warrants [Member] | Maximum [Member] | ||
Accumulated Other Comprehensive Income (Loss) [Line Items] | ||
Warrant exercise price per share | $ 16.80 |
Schedule of Assumptions used to
Schedule of Assumptions used to Calculate Fair Value of Stock Based Compensation (Details) | 3 Months Ended | |
Oct. 31, 2021 | Oct. 31, 2020 | |
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | ||
Risk-free interest rate, minimum | 0.69% | 0.27% |
Risk-free interest rate, maximum | 0.92% | 0.52% |
Volatility, minimum | 86.98% | 85.31% |
Volatility, maximum | 88.89% | 88.44% |
Dividend yield | 0.00% | 0.00% |
Minimum [Member] | ||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | ||
Expected term (years) | 5 years 1 month 17 days | 5 years |
Maximum [Member] | ||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | ||
Expected term (years) | 6 years | 6 years 6 months |
Summary of Stock Option Activit
Summary of Stock Option Activity (Details) $ / shares in Units, $ in Thousands | 3 Months Ended |
Oct. 31, 2021USD ($)$ / sharesshares | |
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | |
Options Outstanding, Ending Balance | 2,852,425 |
2011 Plan [Member] | |
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | |
Options Outstanding, Beginning Balance | 3,111,642 |
Weighted Average Exercise Price, Outstanding Beginning Balance | $ / shares | $ 3.27 |
Options, Granted | 23,400 |
Weighted Average Exercise Price, Granted | $ / shares | $ 2.12 |
Options, Forfeited/Cancelled | (282,617) |
Weighted Average Exercise Price, Forfeited/Cancelled | $ / shares | $ 4.70 |
Options Outstanding, Ending Balance | 2,852,425 |
Weighted Average Exercise Price, Outstanding Ending Balance | $ / shares | $ 3.12 |
Weighted Average Remaining Contract, Outstanding Ending Balance | 8 years 10 months 24 days |
Aggregate Intrinsic Value Outstanding Ending Balance | $ | $ 92 |
Options Exercisable, Ending Balance | 2,083,160 |
Weighted Average Exercise Price, Exercisable , Ending Balance | $ / shares | $ 2.88 |
Weighted Average Remaining Contract, Exercisable Ending Balance | 8 years 9 months 18 days |
Aggregate Intrinsic Value Exercisable Ending Balance | $ | $ 88 |
Summarize Restricted Stock Unit
Summarize Restricted Stock Units (Details) | 3 Months Ended |
Oct. 31, 2021$ / sharesshares | |
Share-based Payment Arrangement [Abstract] | |
Restricted stock units Beginning Balance | shares | 442,749 |
Weighted Average Grant Date Fair Value Beginning Balance | $ / shares | $ 3.24 |
Restricted stock units Granted | shares | (37,480) |
Weighted Average Grant Date Fair Value Granted | $ / shares | $ 3.29 |
Restricted stock units Forfeited/Cancelled | shares | (300,105) |
Weighted Average Grant Date Fair Value Forfeited/Cancelled | $ / shares | $ 3.16 |
Restricted stock units Ending Balance | shares | 105,164 |
Weighted Average Grant Date Fair Value Ending Balance | $ / shares | $ 3.44 |
Summary of Common Stock Reserve
Summary of Common Stock Reserved for Future Issuance (Details) | Oct. 31, 2021shares |
Share-based Payment Arrangement [Abstract] | |
Common Stock options outstanding (within the 2011 Plan and outside of the terms of the 2011 Plan) | 2,852,425 |
Common Stock reserved for restricted stock unit release | 105,164 |
Common Stock authorized for future grant under the 2011 Plan | 1,283,463 |
Common Stock reserved for warrant exercise | 1,706,190 |
Shares issuable under CGP and Sirtex stock purchase agreements (See Note 6) | 1,924,001 |
Common Stock reserved for future ESPP issuance | 29,794 |
Total Common Stock reserved for future issuance | 7,901,037 |
Stock-Based Compensation (Detai
Stock-Based Compensation (Details Narrative) - USD ($) | 3 Months Ended | 6 Months Ended | 12 Months Ended | ||
Oct. 31, 2021 | Oct. 31, 2020 | Jan. 31, 2022 | Jan. 31, 2021 | Jul. 31, 2021 | |
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | |||||
Purchase price of incentive stock options as a percentage of its fair value | 85.00% | ||||
Weighted-average grant date fair value of stock options granted | $ 1.50 | $ 2.58 | |||
Number of shares issued for service, value | $ 42,500 | $ 85,000 | |||
Number of shares authorized for issuance | 7,901,037 | ||||
Common Stock [Member] | |||||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | |||||
Number of shares issued for service | 12,500 | 25,000 | |||
Number of shares issued for service, value | $ 1 | $ 3 | |||
Minimum [Member] | |||||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | |||||
Fair value maturity | 5 years 1 month 17 days | 5 years | |||
Maximum [Member] | |||||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | |||||
Fair value maturity | 6 years | 6 years 6 months | |||
2011 Plan [Member] | |||||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | |||||
Stock option exercisable period | 10 years | ||||
Number of options issued | 23,400 | ||||
Exercise price | $ 2.12 | ||||
2011 Plan [Member] | Stock Option Awards [Member] | |||||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | |||||
Stock-based compensation costs | $ 1,900,000 | $ 1,700,000 | |||
Unrecognized stock-based compensation amortization period | 1 year 5 months 12 days | ||||
Fair value vested | $ 1,100,000 | ||||
2011 Plan [Member] | Restricted Stock Units (RSUs) [Member] | |||||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | |||||
Stock-based compensation costs | $ 76,000 | $ 27,000 | |||
Unrecognized stock-based compensation amortization period | 1 year 7 months 6 days | ||||
2011 Plan [Member] | Restricted Stock Units (RSUs) [Member] | |||||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | |||||
Stock-based compensation costs | $ 300,000 | ||||
2011 Plan [Member] | Employee, Director and Consultants [Member] | |||||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | |||||
Employee stock purchase program description | The 2011 Plan authorizes a total of 4,600,000 shares of common stock for issuance. Under the 2011 Plan, incentive stock options are to be granted at a price that is no less than 100% of the fair value of the Company’s common stock at the date of grant. Stock options vest over a period specified in the individual option agreements entered into with grantees and are exercisable for a maximum period of 10 years after the date of grant. Incentive stock options granted to stockholders who own more than 10% of the outstanding stock of the Company at the time of grant must be issued at an exercise price of no less than 110% of the fair value of the Company’s common stock on the date of grant | ||||
Number of shares authorized for issuance to awards granted | 4,600,000 | ||||
2011 Plan [Member] | Employee, Director and Consultants [Member] | Minimum [Member] | |||||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | |||||
Purchase price of incentive stock options as a percentage of its fair value | 100.00% | ||||
Provisional percentage of outstanding stock owned by stockholders | 110.00% | ||||
2011 Plan [Member] | Employees [Member] | Common Stock [Member] | |||||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | |||||
Number of options issued | 23,400 | 300,000 | |||
Term of stock options | 10 years | 10 years | |||
Exercise price | $ 3.56 | ||||
2011 Plan [Member] | Employees [Member] | Minimum [Member] | |||||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | |||||
Exercise price | 3.43 | ||||
2011 Plan [Member] | Employees [Member] | Minimum [Member] | Common Stock [Member] | |||||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | |||||
Exercise price | $ 2.01 | ||||
2011 Plan [Member] | Employees [Member] | Maximum [Member] | |||||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | |||||
Exercise price | $ 3.82 | ||||
2011 Plan [Member] | Employees [Member] | Maximum [Member] | Common Stock [Member] | |||||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | |||||
Exercise price | $ 2.26 | ||||
2011 Plan [Member] | Employees [Member] | Common Stock [Member] | |||||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | |||||
Number of options issued | 726,576 | ||||
Term of stock options | 10 years | ||||
2011 Plan [Member] | Director [Member] | |||||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | |||||
Number of options issued | 125,000 | ||||
Term of stock options | 10 years | ||||
Exercise price | $ 3.43 | ||||
2011 Plan [Member] | Consultants [Member] | |||||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | |||||
Number of options issued | 25,000 | ||||
Term of stock options | 10 years | ||||
Exercise price | $ 3.82 | ||||
Number of shares issued for service | 12,500 | 25,000 | |||
Number of shares issued for service, value | $ 40,000 | $ 100,000 | |||
2011 Plan [Member] | Employee, Director and Consultants [Member] | Stock Option Awards [Member] | |||||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | |||||
Stock-based compensation costs | 500,000 | 1,900,000 | |||
2011 Plan [Member] | Employee, Director and Consultants [Member] | Stock Option Awards [Member] | Research and Development Expense [Member] | |||||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | |||||
Stock-based compensation costs | 300,000 | 1,000,000 | |||
2011 Plan [Member] | Employee, Director and Consultants [Member] | Stock Option Awards [Member] | General and Administrative Expense [Member] | |||||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | |||||
Stock-based compensation costs | 200,000 | 900,000 | |||
2015 Employee Stock Purchase Plan [Member] | |||||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | |||||
Stock-based compensation costs | $ 1,200 | $ 4,100 | |||
Number of shares authorized for issuance | 50,000 | ||||
Remaining shares to be issued | 29,794 | ||||
Discount from market price, offering date | 15.00% | ||||
Fair market value of unvested shares, percentage | 15.00% | ||||
Fair value maturity | 6 months | ||||
Fair value risk free interest rate | 0.10% | ||||
Fair value volatility rate | 122.84% | ||||
Fair value forfeitures percentage | 0.00% | ||||
Fair value dividend | $ 0 | ||||
2015 Employee Stock Purchase Plan [Member] | Six Month Call On Unvested Share [Member] | |||||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | |||||
Fair market value of unvested shares, percentage | 85.00% | ||||
2015 Employee Stock Purchase Plan [Member] | Forecast [Member] | |||||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | |||||
Fair value maturity | 6 months | ||||
Fair value risk free interest rate | 0.05% | ||||
Fair value volatility rate | 72.99% | ||||
Fair value forfeitures percentage | 0.00% | ||||
Fair value dividend | $ 0 |
Commitments and Contingencies (
Commitments and Contingencies (Details Narrative) - USD ($) | 3 Months Ended | |
Oct. 31, 2021 | Jul. 31, 2021 | |
Collaborative Arrangement and Arrangement Other than Collaborative [Line Items] | ||
Accrued Employee Benefits, Current | $ 350,104 | |
Employment Agreements [Member] | Chief Executive Officer [Member] | ||
Collaborative Arrangement and Arrangement Other than Collaborative [Line Items] | ||
Restricted Stock, Value, Shares Issued Net of Tax Withholdings | 365,000 | |
Accrued Employee Benefits, Current | $ 350,000 |
Schedule of Operating Lease Lia
Schedule of Operating Lease Liabilities (Details) - USD ($) | Oct. 31, 2021 | Jul. 31, 2021 |
Leases | ||
Operating lease right-of-use assets | $ 5,350,864 | $ 5,445,744 |
Current portion included in current liabilities | 1,002,038 | 845,483 |
Long-term portion included in non-current liabilities | 4,976,279 | $ 5,238,207 |
Total operating lease liabilities | $ 5,978,317 |
Schedule of Lease Expenses (Det
Schedule of Lease Expenses (Details) | 3 Months Ended |
Oct. 31, 2021USD ($) | |
Leases | |
Operating lease cost | $ 369,792 |
Total lease expense | $ 369,792 |
Schedule of Other Information R
Schedule of Other Information Related to Leases (Details) | Oct. 31, 2021 |
Leases | |
Weighted-average remaining lease term | 4 years 9 months 18 days |
Weighted-average discount rate | 9.96% |
Schedule of Cash Flow Informati
Schedule of Cash Flow Information Related to Operating Leases (Details) | 3 Months Ended |
Oct. 31, 2021USD ($) | |
Leases | |
Cash paid for operating lease liabilities | $ 380,284 |
Total cash flows related to operating lease liabilities | $ 380,284 |
Schedule of Future Minimum Leas
Schedule of Future Minimum Lease Payments Under Non-Cancellable Lease (Details) | Oct. 31, 2021USD ($) |
Leases | |
2022– the remainder of the fiscal year | $ 1,162,716 |
2023 | 1,585,224 |
2024 | 1,539,142 |
2025 | 1,516,126 |
2026 | 1,533,882 |
Thereafter | 240,688 |
Total minimum lease payments | 7,577,778 |
Less: Imputed interest | (1,599,461) |
Total | $ 5,978,317 |
401(k) Plan (Details Narrative)
401(k) Plan (Details Narrative) - USD ($) | May 15, 2012 | Oct. 31, 2021 | Oct. 31, 2020 |
Defined Benefit Plan Disclosure [Line Items] | |||
Defined Contribution Plan, Maximum Annual Contributions Per Employee, Percent | 100.00% | ||
Defined Contribution Plan, Employer Matching Contribution, Percent of Match | 100.00% | ||
Defined Contribution Plan, Cost | $ 54,000 | $ 28,000 | |
Maximum [Member] | |||
Defined Benefit Plan Disclosure [Line Items] | |||
Defined Contribution Plan, Employers Matching Contribution, Annual Vesting Percentage | 3.00% |
Related Party Transactions (Det
Related Party Transactions (Details Narrative) - USD ($) | Aug. 19, 2020 | Jan. 31, 2021 | Oct. 31, 2021 | Oct. 31, 2020 | Jul. 31, 2021 |
Sale of stock | 4,608,589 | ||||
Shares price, per share | $ 3.25 | ||||
Number of common stock shares issued | $ 13,513,638 | ||||
Liability under co-promotion agreement related party | $ 5,000,000 | $ 5,000,000 | |||
Funded Research and Development Arrangement [Member] | |||||
Share Based Compensation Arrangement by Share Based Payment Award, Fair Value Assumptions Expected Forfeiture Rate | 42.00% | ||||
Sirtex [Member] | |||||
[custom:NonrefundablePayment] | $ 5,000,000 | ||||
Additional non-refundable and non-creditable option exercise fee | $ 25,000,000 | ||||
Cash | 20,000,000 | ||||
Number of common stock shares issued | $ 5,000,000 | ||||
Equity Method Investment, Ownership Percentage | 8.00% | ||||
Liability under co-promotion agreement related party | $ 5,000,000 | ||||
Sirtex [Member] | Funded Research and Development Arrangement [Member] | |||||
Share Based Compensation Arrangement by Share Based Payment Award, Fair Value Assumptions Expected Forfeiture Rate | 49.00% |