Unless the context indicates otherwise, all references to "OncoSec," "the
Company," "we," "us" and "our" in this report refer to
This discussion and analysis of our financial condition and results of
operations is not a complete description of our business or the risks associated
with an investment in our common stock. As a result, this discussion and
analysis should be read together with our condensed consolidated financial
statements and related notes included in this report, as well as the other
disclosures in this report and in the other documents we file from time to time
with the
This discussion and analysis and the other disclosures in this report contain
forward-looking statements within the meaning of Section 27A of the Securities
Act of 1933, as amended, or Securities Act, and Section 21E of the Securities
Exchange Act of 1934, as amended, or Exchange Act. Forward-looking statements
relate to future events or circumstances or our future performance and are based
on our current assumptions, expectations and beliefs about future developments
and their potential effect on our business. All statements in this report that
are not statements of historical fact could be forward-looking statements. The
forward-looking statements in this discussion and analysis and elsewhere in this
report include statements about, among other things, the status, progress and
results of our clinical programs and our expectations regarding our liquidity
and performance, including our expense levels, and the potential impact of the
COVID-19 pandemic. Forward-looking statements are only predictions and are not
guarantees of future performance, and they are subject to known and unknown
risks, uncertainties and other factors, including the risks described under the
heading "Risk Factors" herein and in Part I, Item IA of the Company's most
recent Annual Report on Form 10-K and similar discussions contained in the other
documents we file from time to time with the
Overview
We are 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. Our core technology platform ImmunoPulse® is a drug-device therapeutic
modality platform comprised of proprietary intratumoral electroporation ("EP")
delivery devices (the "OMS EP Device") and a proprietary DNA plasmid delivery
and application method that triggers transient expression of target protein in
cells. The OMS EP Device is designed to promote cellular uptake of 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 paired with
disposable applicators. Our 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. The activation of the
appropriate inflammatory response can drive a systemic anti-tumor response
against untreated tumors in other parts of the body. In 2017, we received Fast
Track Designation and Orphan Drug Designation from the
Our current focus is to pursue our study of TAVO™-EP in combination with KEYTRUDA® (pembrolizumab) in melanoma.
26 Performance Outlook
As a result of recent cash runway and working capital limitations, we expect to use our available working capital in the near term primarily for the advancement of our existing and planned clinical melanoma programs, including delivery of the KEYNOTE-695 trial results. In order to preserve our existing working capital, we have decreased clinical work on our other clinical trials and studies, including those involving triple negative breast cancer. We anticipate our spending on clinical programs and the development of our next-generation OMS EP Device will continue throughout our current fiscal year. Our spending on research and development programs will be prioritized to support development of TAVO™-EP in melanoma, based on our current focus on the KEYNOTE-695 trial. Due to ongoing restructuring efforts, we expect our cash-based general and administrative expenses to remain relatively flat in the near term, as we seek to continue to leverage internal resources and automate processes to decrease our outside services expenses. See "Results of Operations" below for more information.
Restructuring Plan
On
We currently estimate that we will incur charges of approximately
The charges that we expect to incur in connection with the Restructuring Plan are estimates and subject to a number of assumptions, and actual results may differ materially. The foregoing estimated amounts do not include any non-cash charges associated with stock-based compensation. We expect to operationalize additional cost reduction actions that will include other incremental cost reduction actions unrelated to workforce reductions.
COVID-19
Our operational and financial performance have been affected by the COVID-19 pandemic. Our clinical trials have experienced delays in patient enrollment, potentially due to prioritization of hospital resources toward the COVID-19 pandemic or concerns among patients about participating in clinical trials during a public health emergency. The COVID-19 pandemic is also affecting the operations of government entities, such as the FDA, as well as contract research organizations, third-party manufacturers, and other third-parties upon whom we rely. The extent of the impact on our operations cannot be ascertained at this time.
27
Results of Operations for the Three Months Ended
The unaudited financial data for the three months ended
October 31, October 31, $ % 2022 2021 Change Change Revenue $ - $ - $ - - Expenses Research and development 4,768,372 6,645,771 (1,877,399 ) (28 ) General and administrative 2,538,497 3,269,723 (731,226 ) (22 ) Loss from operations (7,306,869 ) (9,915,494 ) 2,608,625 (26 ) Other income (expense), net 38,098 (2,010 ) 40,108 (1995 ) Interest expense (11,081 ) (8,045 ) (3,036 ) 38 Foreign currency exchange gain (loss), net (781,546 ) 116,924 (898,470 ) (768 ) Loss before income taxes (8,061,398 ) (9,808,625 ) 1,747,227 (18 ) Income tax (benefit) expense - - - - Net loss$ (8,061,398 ) $ (9,808,625 ) $ 1,747,227 (18 ) Revenue
We have not generated any revenue since our inception, and we do not anticipate generating revenue in the near term.
Research and Development Expenses
Our research and development expenses decreased by approximately
General and Administrative
Our general and administrative expenses decreased by
Foreign Currency Exchange Gain (Loss), Net
Foreign currency exchange gain (loss), net, decreased by approximately
28
Liquidity and Capital Resources
Working Capital
The following table and subsequent discussion summarize our working capital as of each of the periods presented:
At AtOctober 31, 2022 July 31, 2022
Current assets$ 8,633,159 $ 15,232,471 Current liabilities 6,909,514 6,633,328 Working capital$ 1,723,645 $ 8,599,143 Current Assets
Current assets as of
Current Liabilities
Current liabilities as of
Cash Flow
Cash Used in Operating Activities
Net cash used in operating activities for the three months ended
Cash Used in Financing Activities
Net cash used in financing activities was
Uses of Cash and Cash Requirements
Our primary uses of cash have been to finance clinical and research and development activities focused on the identification and discovery of new potential product candidates, the development of innovative and proprietary medical approaches for the treatment of cancer, and the design and advancement of pre-clinical and clinical trials and studies related to our pipeline of product candidates. We also use our capital resources on general and administrative activities and building and strengthening our corporate infrastructure, programs and procedures to enable compliance with applicable federal, state and local laws and regulations.
Our primary objectives for the next 12 months are to continue the advancement of our KEYNOTE-695 trial and to continue our research and development activities for our next-generation EP device. In addition, we expect to pursue capital-raising transactions, which could include equity or debt financings, in the near term to fund our existing and planned operations and acquire and develop additional assets and technology consistent with our business objectives as opportunities arise.
29
Going Concern and Management's Plans
We have sustained losses in all reporting periods since inception, with an
accumulated deficit of approximately
As of
We will need to raise additional capital to continue operating our business and fund our planned operations, including research and development, clinical trials and, if regulatory approval is obtained, commercialization of its product candidates. In addition, we will require additional financing if we desire 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 us when needed, that Management will be able to obtain financing on terms acceptable to us, or whether we 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 "Nasdaq Deficiency Notice" below. 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 we are unable to raise sufficient additional funds when needed, on favorable terms or at all, we will not be able to continue the development of our product candidates as currently planned or at all, will need to reevaluate our planned operations and may need to delay, scale back or eliminate some or all of our development programs, reduce expenses or cease operations, any of which would have a significant negative impact on our prospects and financial condition.
Sources of Capital
We have not generated any revenue since our inception, and we do not anticipate generating revenue in the near term. Historically, we have raised the majority of the funding for our business through offerings of our common stock and warrants to purchase our common stock. If we issue equity or convertible debt securities to raise additional funds, our existing stockholders would experience further dilution, and the new equity or debt securities may have rights, preferences and privileges senior to those of our existing stockholders. If we incur debt, our fixed payment obligations, liabilities and leverage relative to our equity capitalization would increase, which could increase the cost of future capital. Further, the terms of any debt securities we issue or borrowings we incur, if available, could impose significant restrictions on our operations, such as limitations on our ability to incur additional debt or issue additional equity or other operating restrictions that could adversely affect our ability to conduct our business, and any such debt could be secured by any or all of our assets pledged as collateral. Additionally, we may incur substantial costs in pursuing future capital, including investment banking, legal and accounting fees, printing and distribution expenses and other costs.
30 Reverse Stock Split
Our Board of Directors approved a reverse stock split of the Company's
authorized, issued and outstanding shares of common stock at a ratio of 1-for-22
(the "Reverse Stock Split"). The Reverse Stock Split became effective on
Convertible Promissory Note -
On
Subject to the consent of GDDL, the Note is convertible into such number of
fully paid and non-assessable shares of the Company's common stock, par value
Additionally, if at any time after the Funding Date the last closing bid price
of a share of Common Stock as reported on the Nasdaq for ten consecutive trading
days or the average closing bid price of a share Common Stock as reported on
Nasdaq for the thirty trading days immediately preceding such date is equal to
or exceeds
The unpaid principal of and any accrued interest on the Note constitute
unsubordinated obligations of the Company and are senior and preferred in right
of payment to all equity securities of the Company outstanding as of the Funding
Date, which are secured by all of the Company's right, title and interest, in
and to certain of the Company's intellectual property rights in
31December 2022 Offering
On
The Offering closed on
32 Nasdaq Deficiency Notice
On
On
Critical Accounting Policies
Use of Estimates
The accompanying consolidated financial statements have been prepared in
conformity with
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, we account 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 we are obligated to repay the related party.
33 Equity-Based Awards
We grant equity-based awards (typically stock options or restricted stock units) under our stock-based compensation plan and occasionally outside of our stock-based compensation plan, with terms generally similar to the terms under our stock-based compensation plan. We estimate 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. We estimate the fair value of restricted stock unit awards based on the closing price of the Company's common stock on the date of grant.
Leases
We determine if an arrangement is a lease at inception. Operating lease right of use ("ROU") assets represent our right to use an underlying asset during the lease term, and operating lease liabilities represent our 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 our 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 our 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. Our lease terms may include options to extend or terminate the lease when it is reasonably certain that we will exercise that option. Leases with a term of 12 months or less are not recognized on the consolidated balance sheets. Our 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. We account for lease and non-lease components as a single lease component for all its leases.
Recent Accounting Pronouncements
Information regarding recent accounting pronouncements is contained in Note 2 to our consolidated financial statements included in this report.
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