The accompanying notes are an integral part of
these condensed consolidated financial statements.
Notes
to Condensed Consolidated Financial Statements
(Unaudited)
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 to OncoSec
Medical Incorporated 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 augment anti-tumor immune responses for the treatment of cancers. Its core technology platform
ImmunoPulse® is a drug-device therapeutic modality platform comprised of a proprietary intratumoral electroporation (“EP”)
delivery device (the “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 the 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 (“FDA”) for TAVO™ in metastatic melanoma, which could qualify TAVO™ for expedited FDA review,
a rolling Biologics License Application (“BLA”) 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 inhibitor (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 & Co., Inc. (“Merck”) in
connection with the KEYNOTE-695 study. Pursuant to the terms of the agreement, each company will bear its own costs related to manufacturing
and supply of its product, as well as be responsible for its 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 were exposed to treatment with ipilimumab and progressed on prior anti-PD-1
checkpoint inhibitor. The amendment also enabled enrollment of approximately 25 additional patients to be treated with an updated version
of the OMS EP Device (i.e., GenPulseTM generator and Series 3 Applicator), in preparation for seeking FDA approval.
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 the safety and efficacy of TAVO™ in combination with KEYTRUDA® in patients with inoperable locally advanced or
metastatic TNBC who have previously failed at least one systemic chemotherapy or immunotherapy (Cohort 1) or TAVO™ in combination
with KEYTRUDA® and chemotherapy in patients with inoperable locally advanced or metastatic TNBC who have had no prior systemic therapy
in the advanced or metastatic setting (Cohort 2). In May 2018, the Company entered into a second clinical trial collaboration and supply
agreement with a subsidiary of Merck with respect to the KEYNOTE-890 study, Cohort 1. Pursuant to the terms of the agreement, each company
will bear its own costs related to manufacturing and supply of its product, as well as be responsible for its 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 to include KEYNOTE-890, Cohort 2. 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 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 2023.
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. 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.
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. Enrollment for this trial is expected
to be completed in 2023.
In
November 2020, the Company obtained an exclusive license 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 2021, the Company announced that it received authorization to CE mark the OMS EP Device for use in solid tumors. That CE mark indicates
compliance with Medical Device Directives (MDD) of the European Commission for the OMS EP Device as configured at the time. Subsequent
to receiving the CE mark for that version of the OMS EP Device, the Company has advanced the design of the applicator component of the
OMS EP Device, which the Company refers to as the Series 3 Applicator. This newer version of the OMS EP Device, which still includes
the GenPulseTM generator, is currently used as an investigational device in clinical trial sites in Australia, the EU and
Switzerland. The Company is currently seeking FDA agreement for investigational use of the GenPulseTM and the Series
3 Applicator in US clinical sites.
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 proprietary plasmid-DNA and delivered intratumorally
using EP. Specifically, the Company is developing proprietary 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 APOLLOTM
EP generator and Cliniporator®, and is expected to enable transfection of immunologically relevant genes into cells
located in visceral organs. In early 2020, the Company had two poster presentations, one at the Society for Interventional Oncology and
one at the Society for Interventional Radiology, where it presented preclinical data pertaining to visceral delivery of plasmid therapy.
Additionally, the Company has successfully completed several large animal studies to assess VLA design. The Company expected to bring
a VLA into the clinic in 2023. However, this timeline is under evaluation and may extend beyond 2023. The Company believes that the flexibility
of the Company’s proprietary plasmid-DNA technology allows the Company to deliver other immunologically relevant molecules into
the tumor microenvironment in addition to the delivery of plasmid-DNA encoding for IL-12.
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 April 30, 2022, the condensed consolidated statements of operations for the
three and nine months ended April 30, 2022 and 2021, the condensed consolidated statements of comprehensive loss for the three and nine
months ended April 30, 2022 and 2021, the condensed consolidated statements of stockholders’ equity for the three and nine months
ended April 30, 2022 and 2021, and the condensed consolidated statements of cash flows for the nine months ended April 30, 2022 and 2021,
are unaudited, but include all adjustments (consisting of normal recurring adjustments) that, in the opinion of management, are
necessary for a fair presentation of the Company’s financial position, results of operations and cash flows for the periods presented
and necessary in order to make the Company’s financial statements not misleading. The condensed consolidated results of
operations for the three and nine months ended April 30, 2022 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.
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 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 the Company’s
ability to continue as a going concern and certain calculations related to that determination, 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 amount insured by the Federal Deposit Insurance Corporation and $250,000 AUD (approximately $176,000 USD)
insured by the Australian Financial Claims Scheme. The Company has not experienced any losses in such accounts and management believes
that the Company does not have significant credit risk with respect to such cash and cash equivalents.
Property
and Equipment
The
Company’s capitalization threshold is $5,000 for property and equipment. The cost of property and equipment is depreciated on a
straight-line basis over the estimated useful lives of the related assets. The useful lives of property and equipment for the purpose
of computing depreciation are as follows:
Schedule of Useful Lives of Property and Equipment for Purpose of Computing Depreciation
Computers
and equipment: |
|
3
to 10 years |
Computer
software: |
|
1
to 3 years |
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 agreement cost represents 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 Accounting
Standards Codification (“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 April 30, 2022 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 April 30, 2022 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 and Nine Months
Ended | | |
For the Three and Nine Months
Ended | |
| |
April 30, 2022 | | |
April 30, 2021 | |
Stock options | |
| 2,323,314 | | |
| 2,491,898 | |
Restricted stock units | |
| 74,805 | | |
| 21,541 | |
Warrants | |
| 1,706,190 | | |
| 1,714,315 | |
Total | |
| 4,104,309 | | |
| 4,227,754 | |
Stock-Based
Compensation
The
Company grants equity-based awards (typically stock options or restricted stock units) under its stock-based compensation plan and occasionally
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% of the lesser of (i) the fair market value of a share of common
stock on the beginning date of the offering period and (ii) the fair market value of a share of common stock on the purchase date of
the offering period, subject to a share and dollar limit as defined in the plan and subject to the applicable legal requirements. There
are two six-month offering periods during each fiscal year, ending on January 31 and July 31.
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 months or less are not recognized on the condensed consolidated balance sheets.
The Company’s leases do not contain any residual value guarantees. Lease expense for minimum lease payments is recognized on a
straight-line basis over the lease term. The Company accounts for lease and non-lease components as a single lease component for all
its leases.
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% credit for qualifying research and development expenses. The tax credit does not depend on the Company’s
generation of future taxable income or ongoing tax status or position. Accordingly, the credit is not considered an element of income
tax accounting under ASC 740 “Income Taxes” and is recorded against qualifying research and development expenses.
The
CARES Act
On
March 27, 2020, the president signed into law the Coronavirus Aid, Relief and Economic Security Act (“CARES Act”) providing
nearly $2
trillion in economic relief to eligible businesses
impacted by the coronavirus outbreak. The CARES Act, among other things, includes provisions relating to refundable payroll tax credits,
deferment of employer social security payments, net operating loss (“NOL”) utilization and carryback periods, modifications
to the net interest deduction limitations and technical corrections to tax depreciation methods for qualified improvement property. In
addition to the loan under the Paycheck Protection Program (the “PPP”) under the CARES Act received in April 2020
(see Note 5), the Company continues to review, and intends to seek, any other available potential benefits under the CARES Act
as well as any future legislation signed into law during 2022. Other than the forgiveness of the PPP loan, the effects of the
CARES Act did not have a significant impact on the Company’s condensed consolidated financial statements during the three and nine
months ended April 30, 2022 and 2021.
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.
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 $277.7 million as
of April 30, 2022. 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 June 1, 2022, the Company had cash and cash equivalents of $17.3 million. Since inception, cash flows from financing
activities have been the primary source of the Company’s liquidity. Based on the Company’s current cash levels, the Company
believes its cash resources are insufficient to meet the Company’s anticipated needs for the 12 months following the date the condensed
consolidated financial statements are issued.
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. Similarly, if our common stock is delisted from the Nasdaq Capital Market, it may limit our ability
to raise additional funds (see Note 13). 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 the Company’s prospects and financial condition.
Note
4—Balance Sheet Details
Property
and Equipment
Property
and equipment, net, is comprised of the following:
Schedule of Property and Equipment, Net
| |
April 30, 2022 | | |
July 31, 2021 | |
Equipment and furniture | |
$ | 1,944,540 | | |
$ | 1,919,301 | |
Computer software | |
| 109,242 | | |
| 109,242 | |
Leasehold improvements | |
| 32,651 | | |
| 32,651 | |
Construction in progress | |
| 446,367 | | |
| 234,409 | |
Property and equipment, gross | |
| 2,532,800 | | |
| 2,295,603 | |
Accumulated depreciation and amortization | |
| (1,509,072 | ) | |
| (1,366,782 | ) |
Total | |
$ | 1,023,728 | | |
$ | 928,821 | |
Depreciation
and amortization expense recorded for the three and nine months ended April 30, 2022 was approximately $47,000 and $143,000, respectively.
Depreciation
and amortization expense recorded for the three and nine months ended April 30, 2021 was approximately $47,000 and $143,000, respectively.
Intangible
Assets
Intangible
assets, net, is comprised of the following:
Schedule of Intangible Assets
| |
April 30, 2022 | | |
July 31, 2021 | |
License | |
$ | 495,000 | | |
$ | 495,000 | |
Accumulated amortization | |
| (99,000 | ) | |
| (46,588 | ) |
Total | |
$ | 396,000 | | |
$ | 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 months.
Intangible
asset amortization expense recorded for the three and nine months ended April 30, 2022 was approximately $17,000 and $52,000, respectively.
Intangible
asset amortization expense recorded for the three and nine months ended April 30, 2021 was approximately $17,000 and $29,000, respectively.
At
April 30, 2022, 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
| |
| |
Years ending July 31, | |
| |
2022 – the remainder of the fiscal year | |
$ | 17,471 | |
2023 | |
| 69,882 | |
2024 | |
| 69,882 | |
2025 | |
| 69,882 | |
2026 | |
| 69,882 | |
Thereafter | |
| 99,001 | |
Total | |
$ | 396,000 | |
Accounts
Payable and Accrued Liabilities
Accounts
payable and accrued liabilities are comprised of the following:
Schedule
of Accounts Payable and Accrued Liabilities
| |
April 30, 2022 | | |
July 31, 2021 | |
Research and development costs | |
$ | 2,391,304 | | |
$ | 4,206,926 | |
Professional services fees | |
| 664,035 | | |
| 1,229,040 | |
Other | |
| 90,489 | | |
| 125,679 | |
Total | |
$ | 3,145,828 | | |
$ | 5,561,645 | |
Accrued
Compensation
Accrued
compensation is comprised of the following:
Schedule of Accrued Compensation
|
|
|
April 30, 2022 |
|
|
|
July 31, 2021 |
|
Accrued
payroll |
|
$ |
166,384 |
|
|
$ |
311,590 |
|
401K
payable |
|
|
31,996 |
|
|
|
9,065 |
|
Accrued
severance |
|
|
144,501 |
|
|
|
- |
|
Total |
|
$ |
342,881 |
|
|
$ |
320,655 |
|
Note
5—Note Payable
On
April 27, 2020, the Company was granted a two-year loan (the “Loan”) from the Banc of California in the aggregate amount
of $952,744,
pursuant to the PPP under the CARES Act, which was enacted on March 27, 2020. Interest accrued at 1%
per year, effective on the date of initial disbursement.
The
Company submitted its application for full loan forgiveness on January 6, 2021. On February 12, 2021, the Company received notice that
the full Loan amount of $952,744 and $8,046 of accrued interest had been forgiven. As a result, the Company recorded a $960,790 gain
on extinguishment of debt in its condensed consolidated statement of operations for the three and nine months ended April 30, 2021.
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, which would accrue interest at 2.894% per annum, to partially
fund the payment of the premium of the Company’s Director & Officer insurance. The agreement requires the Company to make eleven
monthly payments of $125,056, including interest starting on July 18, 2021. At April 30, 2022, the outstanding balance related to this
finance agreement was $124,755.
Note
6—Stockholders’ Equity
January
2021 Offering
On
January 25, 2021, the Company completed the offer and sale of an aggregate of 7,711,284 shares of its common stock at a purchase price
of $5.45 per share in a public offering. The gross proceeds from the offering were approximately $42.0 million, and the net proceeds,
after deducting the placement agent’s fee and other offering fees and expenses paid by the Company, were approximately $39.1 million.
In connection with the offering, the Company paid the underwriters an aggregate cash fee equal to 6.0% of the gross proceeds of the offering,
as well as legal and other expenses equal to approximately $0.4 million.
August
2020 Offering
On
August 19, 2020, the Company completed the offer and sale of an aggregate of 4,608,589 shares of its common stock at a purchase price
of $3.25 per share in a registered direct public offering. The gross proceeds from the offering were approximately $15.0 million, and
the net proceeds, after deducting the placement agent’s fee and other offering fees and expenses paid by the Company, were approximately
$13.5 million. In connection with the offering, the Company paid the placement agent and other financial advisors an aggregate cash fee
equal to 8.0% of the gross proceeds of the offering, as well as legal and other expenses equal to approximately $0.3 million.
Common
Stock Option Exercise
During
the nine months ended April 30, 2022, shares of common stock issued related to option exercises totaled 130,000. The Company realized
proceeds of approximately $0.2 million from the stock option exercises. During the nine months ended April 30, 2021, shares of common
stock issued related to option exercises totaled 294,884. The Company realized proceeds of approximately $0.5 million from the stock
option exercises.
Outstanding
Warrants
There
were no warrants exercised during the nine months ended April 30, 2022. During the nine months ended April 30, 2021, shares of common
stock issued related to warrant exercises totaled 1,389,261. The Company realized proceeds of approximately $4.8 million from the warrant
exercises.
At
April 30, 2022, the Company had outstanding warrants to purchase 1,706,190 shares of its common stock, with exercise prices ranging from
$3.45 to $16.80, all of which were classified as equity instruments. These warrants expire at various dates between October 2022 and
May 2024.
China
Grand Pharmaceutical and Healthcare Holdings Limited and Sirtex Medical US Holdings, Inc.
On
October 10, 2019, the Company and Grand Pharmaceutical Group Limited (formerly 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 the Company agreed to sell and issue to CGP and Sirtex 10,000,000 shares and 2,000,000 shares,
respectively, of the Company’s common stock for a total purchase price of $30.0 million. The net proceeds, after deducting offering
fees and expenses paid by the Company, were approximately $28.0 million. This transaction closed on February 7, 2020 (the “Closing”).
Pursuant to the Purchase Agreements, CGP and Sirtex were given the right under certain circumstances to purchase in
the future additional shares of common stock in order to maintain CGP and Sirtex’s respective ownership percentages of the
outstanding shares of common stock of the Company as of the Closing.
During
the nine months ended April 30, 2021, shares of common stock issued to third party investors related to warrant exercises totaled 1,389,261.
On April 16, 2021, in accordance with their respective Purchase Agreement, CGP and Sirtex exercised their rights to purchase additional
shares of common stock at a purchase price equal to the same exercise price paid by each warrant holder. The Company issued 1,409,838
shares of common stock to CGP at an exercise
price of $3.45
per share, resulting in gross proceeds of approximately
$4.8
million. The Company issued 281,968
shares of common stock to Sirtex at an exercise
price of $3.45
per share, resulting in gross proceeds of approximately $1.0
million.
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 but not limited to, stock options
and restricted stock units, to employees, directors and consultants. 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.
Modification
of Stock Option Awards
During
the nine months ended April 30, 2021, the compensation committee of the Company’s Board of Directors approved the accelerated vesting
of 791,019 and 91,666 previously granted time-vesting awards for employees and directors, respectively. The Company accounted for the
effects of the stock option modifications described above under the guidance of ASC 718 as follows:
●
The unamortized compensation costs associated with the time-vesting options was expensed on the date of acceleration, which was approximately
$1.2 million and $0.1 million for the employees and directors, respectively.
●
Upon modification, it is required under ASC 718 to analyze the fair value of the instruments, before and after the modification, recognizing
additional compensation cost for any incremental value. The Company computed the fair value of the award immediately prior to the modification
and compared the fair value to that of the modified award. Since the value of the awards were less after the modification as compared
to immediately prior to the modification, no additional compensation expense was recorded.
Stock
Options
During
the nine months ended April 30, 2022, the Company granted options to purchase 23,400 and 25,000 shares of its common stock to employees
and a consultant under the 2011 Plan, respectively. The stock options issued to employees have a 10-year term, vest over two years and
have exercise prices ranging from $2.01 to $2.26. The stock options issued to the consultant have a 10-year term, vest over one year
and have an exercise price of $1.42.
During
the nine months ended April 30, 2021, the Company granted options to purchase 879,226, 125,000 and 25,000 shares of its common stock
to employees, directors and a consultant under the 2011 Plan, respectively. The stock options issued to employees have a 10-year term,
vest over two to three years and have exercise prices ranging from $3.43 to $7.64. The stock options issued to directors have a 10-year
term, vest over one year and have an exercise price of $3.43. The stock options issued to the consultant have a 10-year term, vest over
one year and have an exercise price of $3.82.
During
the nine months ended April 30, 2021, in accordance with Nasdaq Listing Rule 5635(c)(4), the Company granted inducement equity awards
that consisted of options to purchase 520,000 shares of its common stock to employees outside the 2011 Plan. The stock options issued
to the employee are nonqualified, have a 10-year term, vest over one to two years and have exercise prices ranging from $3.56 to $7.45.
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
| |
Nine
Months
Ended
April 30, 2022 | | |
Nine
Months
Ended
April 30, 2021 | |
Expected term (years) | |
| 5.00
– 6.00 years | | |
| 5.00
– 6.50 years | |
Risk-free interest rate | |
| 0.69 – 1.30 | % | |
| 0.27 – 1.13 | % |
Volatility | |
| 86.98 – 90.74 | % | |
| 85.31 – 89.08 | % |
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 nine months ended April 30, 2022: