UNITED STATES
SECURITIES AND EXCHANGE COMMISSION
Washington, D.C. 20549
FORM
| QUARTERLY REPORT PURSUANT TO
SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the quarterly period ended |
or
| TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the transition period from ______ to ______ |
Commission
file number
| (Exact name of registrant as specified in its charter) |
| (State or other jurisdiction of | (I.R.S. Employer | |
| incorporation or organization) | Identification No.) |
| (Address of principal executive offices) | (Zip Code) |
| (Registrant’s telephone number, including area code) |
Securities registered pursuant to Section 12(b) of the Act:
| Title of each class | Trading symbol | Name of exchange on which registered | ||
Indicate by check mark whether the registrant: (1) has filed all reports required to be filed by Section 13 or 15(d) of the Securities Exchange Act of 1934 during the preceding 12 months (or for such shorter period that the registrant was required to file such reports), and (2) has been subject to such filing requirements for the past 90 days.
Indicate by check mark whether the registrant has submitted electronically every Interactive Data File required to be submitted pursuant to Rule 405 of Regulation S-T (§232.405 of this chapter) during the preceding 12 months (or for such shorter period that the registrant was required to submit such files).
Indicate by check mark whether the registrant is a large accelerated filer, an accelerated filer, a non-accelerated filer, smaller reporting company, or an emerging growth company. See the definitions of “large accelerated filer,” “accelerated filer,” “smaller reporting company,” and “emerging growth company” in Rule 12b-2 of the Exchange Act.
| Large accelerated filer ☐ | Accelerated filer ☐ | |
| Smaller
reporting company |
Emerging
growth company |
If an emerging growth company, indicate by check mark if the registrant has elected not to use the extended transition period for complying with any new or revised financial accounting standards provided pursuant to Section 13(a) of the Exchange Act. ☐
Indicate by check mark whether the registrant is a shell company (as defined in Rule 12b-2 of the Exchange Act).
Yes
☐
Indicate the number of shares outstanding of each of the issuer’s classes of common stock, as of the latest practicable date.
On September 1, 2021 the registrant had outstanding shares of Common Stock, par value $.01 per share, which is the registrant’s only class of common stock.
TABLE OF CONTENTS
| ii |
PART I. FINANCIAL INFORMATION
Item 1. Financial Statements.
ANIXA BIOSCIENCES, INC. AND SUBSIDIARIES
CONDENSED CONSOLIDATED BALANCE SHEETS
| July 31, 2021 | October 31, 2020 | |||||||
| (Unaudited) | ||||||||
| ASSETS | ||||||||
| Current assets: | ||||||||
| Cash and cash equivalents | $ | $ | ||||||
| Short-term investments | ||||||||
| Prepaid expenses and other current assets | ||||||||
| Total current assets | ||||||||
| Operating lease right-of-use asset | ||||||||
| Other assets | - | |||||||
| Total assets | $ | $ | ||||||
| LIABILITIES AND EQUITY | ||||||||
| Current liabilities: | ||||||||
| Accounts payable | $ | $ | ||||||
| Accrued expenses | ||||||||
| Operating lease liability | ||||||||
| Total current liabilities | ||||||||
| Commitments and contingencies (Note 10) | ||||||||
| Equity: | ||||||||
| Shareholders’ equity: | ||||||||
| Preferred stock, par value $ per share; shares authorized; shares issued or outstanding | ||||||||
| Series A convertible preferred stock, par value $ per share; shares authorized; shares issued or outstanding | ||||||||
| Common stock, par value $ per share; shares authorized; and shares issued and outstanding, respectively | ||||||||
| Additional paid-in capital | ||||||||
| Accumulated deficit | ( | ) | ( | ) | ||||
| Total shareholders’ equity | ||||||||
| Noncontrolling interest (Note 1) | ( | ) | ( | ) | ||||
| Total equity | ||||||||
| Total liabilities and equity | $ | $ | ||||||
The accompanying notes are an integral part of these condensed consolidated financial statements.
| 1 |
ANIXA BIOSCIENCES, INC. AND SUBSIDIARIES
CONDENSED CONSOLIDATED STATEMENTS OF OPERATIONS (UNAUDITED)
| For the Three Months Ended | For the Nine Months Ended | |||||||||||||||
| July 31, | July 31, | |||||||||||||||
| 2021 | 2020 | 2021 | 2020 | |||||||||||||
| Revenue | $ | $ | $ | $ | ||||||||||||
| Operating costs and expenses: | ||||||||||||||||
| Inventor royalties, contingent legal fees, litigation and licensing expenses | - | - | - | |||||||||||||
| Research and development expenses (including non-cash share-based compensation expenses of $, $, $and $, respectively) | ||||||||||||||||
| General and administrative expenses (including non-cash share-based compensation expenses of $, $, $and $, respectively) | ||||||||||||||||
| Total operating costs and expenses | ||||||||||||||||
| Loss from operations | ( | ) | ( | ) | ( | ) | ( | ) | ||||||||
| Other expense | - | ( | ) | - | ( | ) | ||||||||||
| Interest income | ||||||||||||||||
| Net loss | ( | ) | ( | ) | ( | ) | ( | ) | ||||||||
| Less: Net loss attributable to noncontrolling interest | ( | ) | ( | ) | ( | ) | ( | ) | ||||||||
| Net loss attributable to common shareholders | $ | ( | ) | $ | ( | ) | $ | ( | ) | $ | ( | ) | ||||
| Net loss per common share attributable to common shareholders: Basic and diluted | $ | ( | ) | $ | ( | ) | $ | ( | ) | $ | ( | ) | ||||
| Weighted average common shares outstanding: Basic and diluted | ||||||||||||||||
The accompanying notes are an integral part of these condensed consolidated financial statements.
| 2 |
ANIXA BIOSCIENCES, INC. AND SUBSIDIARIES
CONDENSED CONSOLIDATED STATEMENTS OF SHAREHOLDERS’ EQUITY (UNAUDITED)
FOR THE THREE MONTHS ENDED JULY 31, 2021
| Common Stock | Additional | Total | Non- | |||||||||||||||||||||||||
| Shares | Par Value | Paid-in Capital | Accumulated Deficit | Shareholders’ Equity | controlling Interest | Total Equity | ||||||||||||||||||||||
| Balance, April 30, 2021 | $ | $ | $ | ( | ) | $ | $ | ( | ) | $ | ||||||||||||||||||
| Stock option compensation to employees and directors | - | - | - | - | ||||||||||||||||||||||||
| Expired restricted stock award to employee | ( | ) | ( | ) | - | - | - | |||||||||||||||||||||
| Stock options and warrants issued to consultants | - | - | - | - | ||||||||||||||||||||||||
| Net loss | - | - | - | ( | ) | ( | ) | ( | ) | ( | ) | |||||||||||||||||
| Balance, July 31, 2021 | $ | $ | $ | ( | ) | $ | $ | ( | ) | $ | ||||||||||||||||||
FOR THE THREE MONTHS ENDED July 31, 2020
| Common Stock | Additional | Total | Non- | |||||||||||||||||||||||||
| Shares | Par Value | Paid-in Capital | Accumulated Deficit | Shareholders’ Equity | controlling Interest | Total Equity | ||||||||||||||||||||||
| Balance, April 30, 2020 | $ | $ | $ | ( | ) | $ | $ | ( | ) | $ | ||||||||||||||||||
| Stock option compensation to employees and directors | - | - | - | - | ||||||||||||||||||||||||
| Stock options issued to consultants | - | - | - | - | ||||||||||||||||||||||||
| Common stock issued upon exercise of stock options | - | - | ||||||||||||||||||||||||||
| Common stock issued in at-the-market offering, net of offering expenses of $ | - | - | ||||||||||||||||||||||||||
| Net loss | - | - | - | ( | ) | ( | ) | ( | ) | ( | ) | |||||||||||||||||
| Balance, July 31, 2020 | $ | $ | $ | ( | ) | $ | $ | ( | ) | $ | ||||||||||||||||||
The accompanying notes are an integral part of these condensed consolidated financial statements.
| 3 |
ANIXA BIOSCIENCES, INC. AND SUBSIDIARIES
CONDENSED CONSOLIDATED STATEMENTS OF SHAREHOLDERS’ EQUITY (UNAUDITED)
FOR THE NINE MONTHS ENDED JULY 31, 2021
| Common Stock | Additional | Total | Non- | |||||||||||||||||||||||||
| Shares | Par Value | Paid-in Capital | Accumulated Deficit | Shareholders’ Equity | controlling Interest | Total Equity | ||||||||||||||||||||||
| Balance, October 31, 2020 | $ | $ | $ | ( | ) | $ | $ | ( | ) | $ | ||||||||||||||||||
| Stock option compensation to employees and directors | - | - | - | - | ||||||||||||||||||||||||
| Expired restricted stock award to employee | ( | ) | ( | ) | - | - | - | |||||||||||||||||||||
| Stock options and warrants issued to consultants | - | - | - | - | ||||||||||||||||||||||||
| Common stock issued upon exercise of stock options | - | - | ||||||||||||||||||||||||||
| Common stock issued pursuant to employee stock purchase plan | - | - | ||||||||||||||||||||||||||
| Common stock issued in a public offering, net of offering expenses of $ | - | - | ||||||||||||||||||||||||||
| Common stock issued in at-the-market offering, net of offering expenses of $ | - | - | ||||||||||||||||||||||||||
| Net loss | - | - | - | ( | ) | ( | ) | ( | ) | ( | ) | |||||||||||||||||
| Balance, July 31, 2021 | $ | $ | $ | ( | ) | $ | $ | ( | ) | $ | ||||||||||||||||||
FOR THE NINE MONTHS ENDED JULY 31, 2020
| Common Stock | Additional | Total | Non- | |||||||||||||||||||||||||
| Shares | Par Value | Paid-in Capital | Accumulated Deficit | Shareholders’ Equity | controlling Interest | Total Equity | ||||||||||||||||||||||
| Balance, October 31, 2019 | $ | $ | $ | ( | ) | $ | $ | ( | ) | $ | ||||||||||||||||||
| Stock option compensation to employees and directors | - | - | - | - | ||||||||||||||||||||||||
| Stock options issued to consultants | - | - | - | - | ||||||||||||||||||||||||
| Common stock issued upon exercise of stock options | - | - | ||||||||||||||||||||||||||
| Common stock issued pursuant to employee stock purchase plan | - | - | ||||||||||||||||||||||||||
| Common stock issued in at-the-market offering, net of offering expenses of $ | - | - | ||||||||||||||||||||||||||
| Net loss | - | - | - | ( | ) | ( | ) | ( | ) | ( | ) | |||||||||||||||||
| Balance, July 31, 2020 | $ | $ | $ | ( | ) | $ | $ | ( | ) | $ | ||||||||||||||||||
The accompanying notes are an integral part of these condensed consolidated financial statements.
| 4 |
ANIXA BIOSCIENCES, INC. AND SUBSIDIARIES
CONDENSED CONSOLIDATED STATEMENTS OF CASH FLOWS (UNAUDITED)
| For the nine months ended July 31, | ||||||||
| 2021 | 2020 | |||||||
| Cash flows from operating activities: | ||||||||
| Reconciliation of net loss to net cash used in operating activities: | ||||||||
| Net loss | $ | ( | ) | $ | ( | ) | ||
| Stock option compensation to employees and directors | ||||||||
| Stock options and warrants issued to consultants | ||||||||
| Depreciation of property and equipment | - | |||||||
| Loss on disposal of property and equipment | - | |||||||
| Gain on sale of equipment | ( | ) | - | |||||
| Amortization of operating lease right-of-use asset | ||||||||
| Change in operating assets and liabilities: | ||||||||
| Receivables | - | |||||||
| Prepaid expenses and other current assets | ( | ) | ( | ) | ||||
| Accounts payable | ( | ) | ( | ) | ||||
| Accrued expenses | ( | ) | ||||||
| Operating lease liability | ( | ) | ( | ) | ||||
| Net cash used in operating activities | ( | ) | ( | ) | ||||
| Cash flows from investing activities: | ||||||||
| Disbursements to acquire short-term investments | ( | ) | ( | ) | ||||
| Proceeds from maturities of short-term investments | ||||||||
| Purchase of property and equipment | - | ( | ) | |||||
| Proceeds from sale of equipment | - | |||||||
| Net cash used in investing activities | ( | ) | ( | ) | ||||
| Cash flows from financing activities: | ||||||||
| Gross proceeds from sale of common stock in a public offering | - | |||||||
| Expenses of the public offering | ( | ) | - | |||||
| Gross proceeds from sale of common stock in an at-the-market offering | ||||||||
| Expenses of the at-the-market offering | ( | ) | ( | ) | ||||
| Proceeds from sale of common stock pursuant to employee stock purchase plan | ||||||||
| Proceeds from exercise of stock options | ||||||||
| Net cash provided by financing activities | ||||||||
| Net increase in cash and cash equivalents | | |||||||
| Cash and cash equivalents at beginning of period | ||||||||
| Cash and cash equivalents at end of period | $ | $ | ||||||
| Supplemental cash flow information: | ||||||||
| Cash proceeds from interest income | $ | $ | ||||||
| Supplemental disclosure of non-cash financing activity: | ||||||||
| Fair value of warrants issued in connection with the public offering | $ | $ | ||||||
The accompanying notes are an integral part of these condensed consolidated financial statements.
| 5 |
ANIXA BIOSCIENCES, INC. AND SUBSIDIARIES
NOTES TO CONDENSED CONSOLIDATED FINANCIAL STATEMENTS
(UNAUDITED)
| 1. | BUSINESS AND FUNDING |
Description of Business
As used herein, “we,” “us,” “our,” the “Company” or “Anixa” means Anixa Biosciences, Inc. and its consolidated subsidiaries. Our primary operations involve developing therapies and vaccines that are focused on critical unmet needs in oncology and infectious disease. Our therapeutics programs include the development of a chimeric endocrine receptor T-cell technology, a novel form of chimeric antigen receptor T-cell (“CAR-T”) technology, initially focused on treating ovarian cancer, and discovery and ultimately development of anti-viral drug candidates for the treatment of COVID-19 focused on inhibiting certain protein functions of the virus. Our vaccine programs include the development of a vaccine against breast cancer, specifically triple negative breast cancer (“TNBC”), the most lethal form of the disease, and a vaccine against ovarian cancer.
Our
subsidiary, Certainty Therapeutics, Inc. (“Certainty”), is developing immuno-therapy drugs against cancer. Certainty holds
an exclusive worldwide, royalty-bearing license to use certain intellectual property owned or controlled by The Wistar Institute (“Wistar”)
relating to Wistar’s CAR-T technology. We have initially focused on the development of a treatment for ovarian cancer, but we may
also pursue applications of the technology for the development of treatments for additional solid tumors. The license agreement requires
Certainty to make certain cash and equity payments to Wistar upon achievement of specific development milestones. With respect to Certainty’s
equity obligations to Wistar, Certainty issued to Wistar shares of its common stock equal to five percent (
Certainty, in collaboration with the H. Lee Moffitt Cancer Center and Research Institute, Inc. (“Moffitt”), is advancing toward human clinical testing its CAR-T technology for treating ovarian cancer. We submitted an Investigational New Drug (“IND”) application to the U.S. Food and Drug Administration (“FDA”) in March 2021. In April 2021, the FDA informed us that they needed additional information before allowing us to proceed with the clinical trial. In May 2021, the FDA provided us with the details of their information request. Through an iterative process with the FDA, we responded to their information requests and in August 2021, we received authorization from the FDA to commence enrollment and treatment of patients in a Phase 1 clinical trial. We are performing the activities necessary to prepare for treatment of patients in the Phase 1 clinical trial, and we anticipate treating the first enrolled patient in early 2022.
In April 2020, we entered into a collaboration with OntoChem GmbH (“OntoChem”), to discover and ultimately develop anti-viral drug candidates against COVID-19. Through this collaboration, we utilized advanced computational methods, machine learning, and molecular modeling techniques to perform in silico screening of over 1.2 billion compounds in chemical libraries (including publicly available compounds and OntoChem’s proprietary libraries) to evaluate if any of these compounds could disrupt one of two key enzymes of SARS-CoV-2, the virus that causes the disease COVID-19.
The screening process resulted in the identification of multiple compounds that could potentially disrupt critical enzymes of the virus. Several of these compounds were synthesized and tested in in vitro biological assays. Upon completion of these biological assays, we identified two of the most promising compounds and tested them in animal models. In these animal studies, the two compounds were compared to Remdesivir, which is the only anti-viral drug authorized by the FDA for COVID-19. The data showed that administration of the drugs to infected hamsters did not cause any noticeable adverse effects, and monitoring of weight and general animal behavior demonstrated comparable efficacy of both compounds as well as Remdesivir. Based on this promising data in the animal study, we proceeded to the next stage of drug development and selected one of the compounds around which we are currently performing combinatorial synthetic medicinal chemistry to evaluate whether we can increase potency and optimize pharmacokinetics. In addition, we have added chemical structures which we feel, based on our data and recently published data, could be potent anti-virals.
| 6 |
In May 2021, after completion of the aforementioned animal studies, OntoChem assigned its rights and obligations related to this collaboration to MolGenie GmbH (“MolGenie”), a company spun-out from OntoChem focused on drug discovery and development.
In August 2021, in an attempt to evaluate whether our compounds might be effective against the Delta variant of SARS-CoV-2, we undertook an analysis of certain enzyme mutations in the Delta variant. We note that the Delta variant is characterized by mutations in the spike protein of the virus. Corresponding to the mutations in the spike protein, we found some of the Delta variants exhibited a mutation in the enzyme that is our target. Sequence analysis of several Delta variant samples demonstrated that the resultant enzyme mutation indicates that our novel compounds could be stronger inhibitors of the Delta variant that the original version of the virus.
We hold an exclusive worldwide, royalty-bearing license to use certain intellectual property owned or controlled by The Cleveland Clinic Foundation (“Cleveland Clinic”) relating to certain breast cancer vaccine technology developed at Cleveland Clinic. We are working in collaboration with Cleveland Clinic to develop a method to vaccinate women against contracting breast cancer, focused specifically on TNBC. A specific protein, alpha-lactalbumin, has been identified that is only expressed during lactation in a healthy woman’s mammary tissue. This protein disappears when the woman is no longer lactating, but reappears in many forms of breast cancer, especially TNBC. Studies have shown that vaccinating against this protein prevents breast cancer in mice. In December 2020, we received authorization from the FDA to commence enrollment and treatment of patients in a Phase 1a clinical trial. We are performing the activities necessary to prepare for treatment of patients in the Phase 1a clinical trial, and we anticipate treating the first enrolled patient in September 2021.
In November 2020, we executed a license agreement with Cleveland Clinic pursuant to which the Company was granted an exclusive worldwide, royalty-bearing license to use certain intellectual property owned or controlled by Cleveland Clinic relating to certain ovarian cancer vaccine technology. This technology pertains to the use of vaccines for the treatment or prevention of ovarian cancers which express the anti-Mullerian hormone receptor II protein containing an extracellular domain (“AMHR2-ED”). In healthy tissue, this protein regulates growth and development of egg-containing follicles in the ovary. While expression of AMHR2-ED naturally and markedly declines after menopause, this protein is expressed at high levels in the ovaries of postmenopausal women with ovarian cancer. Researchers at Cleveland Clinic believe that a vaccine targeting AMHR2-ED could prevent the occurrence of ovarian cancer. We entered into a joint development agreement with Cleveland Clinic, to advance this vaccine technology toward human clinical testing.
In May 2021, Cleveland Clinic was granted an award for our ovarian cancer vaccine technology by the National Cancer Institute’s (“NCI”) PREVENT program. The NCI is a part of the National Institutes of Health. The PREVENT program is a peer-reviewed agent development program designed to support preclinical development of innovative interventions and biomarkers for cancer prevention and interception towards clinical trials. The scientific and financial resources of the PREVENT program will be used for our ovarian cancer vaccine technology to perform virtually all pre-clinical research and development, manufacturing and IND-enabling studies. This work will be performed at NCI facilities, by NCI scientific staff and with NCI financial resources and will require no material financial expenditures by the Company, nor the transfer of any rights to the Company’s assets.
Over the next several quarters, we expect the development of our breast and ovarian cancer vaccines, our COVID-19 therapeutic program and Certainty’s CAR-T technology to be the primary focus of the Company. As part of our legacy operations, the Company remains engaged in limited patent licensing activities regarding the Cchek™ liquid biopsy platform (operations for which were suspended in July 2020), as well as in the area of encrypted audio/video conference calling. We do not expect these activities to be a significant part of the Company’s ongoing operations, nor do we expect these activities to require material financial resources or attention of senior management.
| 7 |
Over the past several years, our revenue, if any, was derived from technology licensing and the sale of patented technologies, including revenue from the settlement of litigation. We have not generated any revenue to date from our therapeutics or vaccine programs. In addition, while we pursue our therapeutics and vaccine programs, we may also make investments in and form new companies to develop additional emerging technologies. We do not expect to begin generating revenue with respect to any of our current therapy or vaccine programs in the near term. We hope to achieve a profitable outcome by eventually licensing our technologies to large pharmaceutical companies that have the resources and infrastructure in place to manufacture, market and sell our technologies as therapeutics or vaccines. The eventual licensing of any of our technologies may take several years, if it is to occur at all, and may depend on positive results from human clinical trials.
Funding and Management’s Plans
Based
on currently available information as of September 1, 2021, we believe that our existing cash, cash equivalents, short-term investments
and expected cash flows will be sufficient to fund our activities for at least the next twelve months. We have implemented a business
model that conserves funds by collaborating with third parties to develop our technologies. However, our projections of future cash needs
and cash flows may differ from actual results. If current cash on hand, cash equivalents, short-term investments and cash that may be
generated from our business operations are insufficient to continue to operate our business, or if we elect to invest in or acquire a
company or companies or new technology or technologies that are synergistic with or complementary to our technologies, we may be required
to obtain more working capital. During the nine months ended July 31, 2021, we raised approximately $
Basis of Presentation
The accompanying unaudited condensed consolidated financial statements have been prepared in accordance with generally accepted accounting principles in the United States of America (“US GAAP”) for interim financial information and with the instructions to Form 10-Q and Rule 8-03 of Regulation S-X. Accordingly, certain information and disclosures required by generally accepted accounting principles in annual financial statements have been omitted or condensed. These interim condensed consolidated financial statements should be read in conjunction with the audited consolidated financial statements and related disclosures included in our Annual Report on Form 10-K for the year ended October 31, 2020. The accompanying October 31, 2020 condensed consolidated balance sheet data was derived from the audited financial statements but does not include all disclosures required by US GAAP. The condensed consolidated financial statements include all adjustments of a normal recurring nature which, in the opinion of management, are necessary for a fair statement of our financial position as of July 31, 2021, and results of operations and cash flows for the interim periods represented. The results of operations for the nine months ended July 31, 2021 are not necessarily indicative of the results to be expected for the entire year.
| 8 |
Noncontrolling Interest
Noncontrolling interest represents Wistar’s equity ownership in Certainty and is presented as a component of equity. The following table sets forth the changes in noncontrolling interest for the nine months ended July 31, 2021:
| Balance, October 31, 2020 | $ | ( | ) | |
| Net loss attributable to noncontrolling interest | ( | ) | ||
| Balance, July 31, 2021 | $ | ( | ) |
Revenue Recognition
Our revenue has been derived solely from technology licensing and the sale of patented technologies. Revenue is recognized upon transfer of control of intellectual property rights and satisfaction of other contractual performance obligations to licensees in an amount that reflects the consideration we expect to receive.
We follow the accounting guidance of Accounting Standards Codification 606 (“ASC 606”), Revenue from Contracts with Customers. In accordance with ASC 606 we are required to make certain judgments and estimates in connection with the accounting for revenue. Such judgments and estimates may include determining the existence of a contract and identifying each party’s rights and obligations to transfer goods and services, identifying the performance obligations in the contract, determining the transaction price and allocating the transaction price to separate performance obligations, estimating the timing of satisfaction of performance obligations, determining whether a promise to grant a license is distinct from other promised goods or services and evaluating whether a license transfers to a customer at a point in time or over time.
Our revenue arrangements provide for the payment, within 30 days of execution of the agreement, of contractually determined, one-time, paid-up license fees in settlement of litigation and in consideration for the grant of certain intellectual property rights for patented technologies owned or controlled by the Company. These arrangements typically include some combination of the following: (i) the grant of a non-exclusive, retroactive and future license to manufacture and/or sell products covered by patented technologies owned or controlled by the Company, (ii) a covenant-not-to-sue, (iii) the release of the licensee from certain claims, and (iv) the dismissal of any pending litigation. In such instances, the intellectual property rights granted have been perpetual in nature, extending until the expiration of the related patents. Pursuant to the terms of these agreements, we have no further obligations with respect to the granted intellectual property rights, including no obligation to maintain or upgrade the technology, or provide future support or services. Licensees obtained control of the intellectual property rights they have acquired upon execution of the agreement. Accordingly, the performance obligations from these agreements were satisfied and 100% of the revenue was recognized upon the execution of the agreements.
Cost of Revenues
Cost of revenues include the costs and expenses incurred in connection with our patent licensing and enforcement activities, including inventor royalties paid to original patent owners, contingent legal fees paid to external counsel, other patent-related legal expenses paid to external counsel and licensing and enforcement related research, consulting and other expenses paid to third-parties. These costs are included under the caption “Operating costs and expenses” in the accompanying condensed consolidated statements of operations.
| 9 |
Research and Development Expenses
Research and development expenses, consisting primarily of employee compensation, payments to third parties for research and development activities and other direct costs associated with developing immuno-therapy drugs against cancer, preventative cancer vaccines and anti-viral drug candidates for COVID-19, are expensed in the accompanying condensed consolidated financial statements in the period incurred.
| 2. | PUBLIC OFFERING |
On
March 25, 2021, the Company completed a public offering in which we sold an aggregate of shares of its common stock, which
represented
| 3. | STOCK BASED COMPENSATION |
The Company maintains stock equity incentive plans under which the Company grants incentive stock options, non-qualified stock options, stock appreciation rights, stock awards, performance awards, or stock units to employees, directors and consultants.
Stock Option Compensation Expense
The
compensation cost for service-based stock options granted to employees and directors is measured at the grant date, based on the fair
value of the award using the Black-Scholes pricing model, and is expensed on a straight-line basis over the requisite service period
(the vesting period of the stock option) which is to . We recorded stock-based compensation expense related to service-based
stock options granted to employees and directors of approximately $
For stock options granted to employees and directors that vest based on market conditions, such as the trading price of the Company’s common stock exceeding certain price targets, we use a Monte Carlo Simulation in estimating the fair value at grant date and recognize compensation cost over the implied service period (median time to vest). On May 8, 2018, we issued market condition options to purchase shares of common stock, to our Chairman, President and Chief Executive Officer, vesting at target trading prices of $ to $ per share before , with implied service periods of to months. In October 2018, the first tranche of shares of market condition options became exercisable upon achieving an average closing price above $ per share for consecutive trading days. The remaining tranches did not vest as of May 31, 2021 and expired.
On
June 1, 2021, our Chairman, President and Chief Executive Officer and our Chief Operating Officer and Chief Financial Officer were awarded
options for shares and shares of common stock, respectively, that vest
in four equal installments upon the Company’s share price achieving targets ranging from $to $per share, with implied service periods of three
to fifteen months. The assumptions used in the Monte Carlo Simulation for the June 1, 2021 grants were stock price on date of grant of
$,
contract term of years, expected volatility of %
and risk-free interest rate of %.
We recorded stock-based compensation expense related to market condition stock options of approximately $
| 10 |
The
compensation cost for service-based stock options granted to consultants is measured at the grant date, based on the fair value of the
award using the Black-Scholes pricing model, and is expensed on a straight-line basis over the requisite service period (the vesting
period of the stock option) which is one to three years. We recorded stock-based consulting expense related to stock options granted
to consultants of approximately $
Stock Option Plans
During the nine months ended July 31, 2021, we had two stock option plans: the Anixa Biosciences, Inc. 2010 Share Incentive Plan (the “2010 Share Plan”) and the Anixa Biosciences, Inc. 2018 Share Incentive Plan (the “2018 Share Plan”), which were adopted by our Board of Directors on July 14, 2010 and January 25, 2018, respectively. The 2018 Share Plan was approved by our shareholders on March 29, 2018. Further, we had an additional stock option plan: the Anixa Biosciences, Inc. 2003 Share Incentive Plan (the “2003 Share Plan”), under which all outstanding options expired during the nine months ended July 31, 2020.
Stock Option Activity
During
the three months ended July 31, 2021 and 2020, we granted options to purchase shares and -- shares of common stock, respectively,
and during the nine months ended July 31, 2021 and 2020, we granted options to purchase shares and shares of common
stock, respectively, to employees and consultants, with exercise prices ranging from $ to $ per share, pursuant to the 2018 Share
Plan. During the three months ended July 31, 2021 and 2020, stock options to purchase -- shares and shares of common stock, respectively,
were exercised with aggregate proceeds of approximately $-
2003 Share Plan
The 2003 Share Plan provided for the grant of nonqualified stock options, stock appreciation rights, stock awards, performance awards and stock units to employees, directors and consultants. In accordance with the provisions of the 2003 Share Plan, the plan terminated with respect to the ability to grant future awards on April 21, 2013.
| Shares | Weighted Average Exercise Price Per Share | Aggregate Intrinsic Value | ||||||||||
| Options outstanding at October 31, 2019 | $ | |||||||||||
| Forfeited/Expired | ( | ) | $ | |||||||||
| Options outstanding and exercisable at July 31, 2020 | $ | -- | $ | -- | ||||||||
| 11 |
2010 Share Plan
The 2010 Share Plan provided for the grant of nonqualified stock options, stock appreciation rights, stock awards, performance awards and stock units to employees, directors and consultants. In accordance with the provisions of the 2010 Share Plan, the plan terminated with respect to the ability to grant future awards on July 14, 2020.
| Shares | Weighted Average Exercise Price Per Share | Aggregate Intrinsic Value | ||||||||||
| Options outstanding at October 31, 2020 | | $ | ||||||||||
| Exercised | ( | ) | $ | |||||||||
| Forfeited/Expired | ( | ) | $ | |||||||||
| Options outstanding and exercisable at July 31, 2021 | $ | $ | ||||||||||
Range of Exercise Prices | Number And Exercisable | Weighted Average (in years) | Weighted Average Exercise Price | |||||||||||
| $ | 0 $ - $ | $ | ||||||||||||
| $ | - $ | $ | ||||||||||||
| $ | - $ | $ | ||||||||||||
| Shares | Weighted Average Exercise Price Per Share | Aggregate Intrinsic Value | ||||||||||
| Options outstanding at October 31, 2019 | $ | |||||||||||
| Exercised | ( | ) | $ | |||||||||
| Forfeited/Expired | ( | ) | $ | |||||||||
| Options outstanding at July 31, 2020 | $ | $ | ||||||||||
| Options exercisable at July 31, 2020 | $ | $ | ||||||||||
| 12 |
| Options Outstanding | Options Exercisable | |||||||||||||||||||||||||
| Range of Exercise Prices | Number Outstanding | Weighted Average Remaining Contractual Life (in years) |
Weighted Average Exercise Price | Number Exercisable | Weighted Average Remaining Contractual Life (in years) |
Weighted Average Exercise Price | ||||||||||||||||||||
| $ | - $ | $ | $ | |||||||||||||||||||||||
| $ | - $ | $ | $ | |||||||||||||||||||||||
| $ | - $ | $ | $ | |||||||||||||||||||||||
2018 Share Plan
The 2018 Share Plan provides for the grant of incentive stock options, nonqualified stock options, stock appreciation rights, stock awards, performance awards and stock units to employees, directors and consultants. As of July 31, 2021, the 2018 Share Plan had shares available for future grants.
| Shares | Weighted Average Exercise Price Per Share |
Aggregate Intrinsic Value | ||||||||||
| Options outstanding at October 31, 2020 | $ | |||||||||||
| Granted | $ | |||||||||||
| Exercised | ( |
) | $ | |||||||||
| Forfeited/Expired | ( |
) | $ | |||||||||
| Options outstanding at July 31, 2021 | $ | $ | ||||||||||
| Options exercisable at July 31, 2021 | $ | $ | ||||||||||
| Options Outstanding | Options Exercisable | |||||||||||||||||||||||||
| Range of Exercise Prices | Number Outstanding |
Weighted Average Remaining Contractual Life (in years) |
Weighted Average Exercise Price | Number Exercisable |
Weighted Average Remaining Contractual Life (in years) |
Weighted Average Exercise Price | ||||||||||||||||||||
| $ | - $ | $ | $ | |||||||||||||||||||||||
| $ | - $ | $ | $ | |||||||||||||||||||||||
| 13 |
| Shares | Weighted Average Exercise Price Per Share |
Aggregate Intrinsic Value | ||||||||||
| Options outstanding at October 31, 2019 | $ | |||||||||||
| Granted | $ | |||||||||||
| Forfeited/Expired | ( |
) | $ | |||||||||
| Options outstanding at July 31, 2020 | $ | $ | -- | |||||||||
| Options exercisable at July 31, 2020 | $ | $ | -- | |||||||||
| Options Outstanding | Options Exercisable | |||||||||||||||||||||||||
| Range of Exercise Prices | Number Outstanding | Weighted Average Remaining Contractual Life (in years) |
Weighted Average Exercise Price | Number Exercisable | Weighted Average Remaining Contractual Life (in years) |
Weighted Average Exercise Price | ||||||||||||||||||||
| $ | $ | $ | ||||||||||||||||||||||||
| $ | - $ | $ | $ | |||||||||||||||||||||||
Non-Plan Options
In addition to options granted under stock option plans, during the years ended October 31, 2012 and 2013, the Board of Directors approved the grant of stock options to certain employees and directors (the “Non-Plan Options”).
| Shares | Weighted Average Exercise Price Per Share |
Aggregate Intrinsic Value |
||||||||||
| Options outstanding at October 31, 2020 | $ | |||||||||||
| Exercised | ( |
) | $ | |||||||||
| Options outstanding and exercisable at July 31, 2021 |
$ | $ | ||||||||||
| Range of Exercise Prices |
Number Outstanding and Exercisable |
Weighted Average Remaining Contractual Life (in years) |
Weighted Average Exercise Price |
|||||||||||
| $ | $ | |||||||||||||
| 14 |
| Shares | Weighted Average Exercise Price Per Share |
Aggregate Intrinsic Value | ||||||||||
| Options outstanding at October 31, 2019 | $ | |||||||||||
| Options outstanding and exercisable at July 31, 2020 |
$ | $ | ||||||||||
| Range of Exercise Prices |
Number Outstanding and Exercisable |
Weighted Average Remaining Contractual Life (in years) |
Weighted Average Exercise Price |
|||||||||||
| $ | $ | |||||||||||||
Stock Awards
On May 8, 2018, a restricted stock award of shares of common stock was granted under the 2018 Share Plan to our Chairman, President and Chief Executive Officer. The restricted stock award was to vest in its entirety upon achievement of a target trading price of $ per share of the Company’s common stock before . The restricted stock award did not vest as of May 31, 2021 and expired. For restricted stock awards vesting upon achievement of a price target of our common stock we use a Monte Carlo Simulation in estimating the fair value at grant date and recognize compensation cost over the implied service period (median time to vest). We did not record any compensation expense related to the restricted stock award during the nine months ended July 31, 2021 and 2020.
Employee Stock Purchase Plan
The Company maintains the Anixa
Biosciences, Inc. Employee Stock Purchase Plan which permits eligible employees to purchase shares at not less than % of the market
value of the Company’s common stock on the offering date or the purchase date of the applicable offering period, whichever is lower.
The plan was adopted by our Board of Directors on August 13, 2018 and approved by our shareholders on September 27, 2018. During the nine
months ended July 31, 2021 and 2020, employees purchased and shares, respectively, with aggregate proceeds of approximately
$
Warrants
On October 30, 2020 we issued
a warrant, expiring on
As discussed in Note 2, in connection
with the March 25, 2021 public offering we issued to certain designees of the underwriter, as compensation, warrants to purchase
| 15 |
As of July 31, 2021, we also
had warrants outstanding to purchase
| 4. | FAIR VALUE MEASUREMENTS |
US GAAP defines fair value and establishes a framework for measuring fair value. We have categorized our financial assets and liabilities, based on the priority of the inputs to the valuation technique, into a three-level fair value hierarchy as set forth below. If the inputs used to measure the financial instruments fall within different levels of the hierarchy, the categorization is based on the lowest level input that is significant to the fair value measurement of the instrument.
Financial assets and liabilities recorded in the accompanying condensed consolidated balance sheets are categorized based on the inputs to the valuation techniques as follows:
Level 1 - Financial assets and liabilities whose values are based on unadjusted quoted prices for identical assets or liabilities in an active market which we have the ability to access at the measurement date.
Level 2 - Financial assets and liabilities whose values are based on quoted market prices in markets where trading occurs infrequently or whose values are based on quoted prices of instruments with similar attributes in active markets.
Level 3 – Financial assets and liabilities whose values are based on prices or valuation techniques that require inputs that are both unobservable and significant to the overall fair value measurement. These inputs reflect management’s own assumptions about the assumptions a market participant would use in pricing the asset and liabilities.
The following table presents the hierarchy for our financial assets measured at fair value on a recurring basis as of July 31, 2021:
| Level 1 | Level 2 | Level 3 | Total | |||||||||||||
| Money market funds: | ||||||||||||||||
| Cash and cash equivalents | $ | $ | $ | $ | ||||||||||||
| Certificates of deposit: | ||||||||||||||||
| Cash and cash equivalents | ||||||||||||||||
| Short-term investments | ||||||||||||||||
| Treasury bills and bonds: | ||||||||||||||||
| Short-term investments | ||||||||||||||||
| Total financial assets | $ | $ | $ | $ | ||||||||||||
The following table presents the hierarchy for our financial assets measured at fair value on a recurring basis as of October 31, 2020:
| Level 1 | Level 2 | Level 3 | Total | |||||||||||||
| Money market funds: | ||||||||||||||||
| Cash and cash equivalents | $ | $ | $ | $ | ||||||||||||
| Certificates of deposit: | ||||||||||||||||
| Cash and cash equivalents | ||||||||||||||||
| Short-term investments | ||||||||||||||||
| Total financial assets | $ | $ | $ | $ | ||||||||||||
| 16 |
Our non-financial assets that are measured on a non-recurring basis include our other assets which are measured using fair value techniques whenever events or changes in circumstances indicate a condition of impairment exists. The estimated fair value of prepaid expenses and other current assets, accounts payable and accrued expenses approximates their individual carrying amounts due to the short-term nature of these measurements. Cash and cash equivalents are stated at carrying value which approximates fair value.
| 5. | ACCRUED EXPENSES |
Accrued expenses consist of the following as of:
| July 31, 2021 | October 31, 2020 | |||||||
| Payroll and related expenses | $ | $ | ||||||
| Accrued royalty and contingent legal fees | ||||||||
| Accrued collaborative research and license expense | - | |||||||
| Accrued other | ||||||||
| $ | $ | |||||||
| 6. | NET LOSS PER SHARE OF COMMON STOCK |
Basic net loss per common share (“Basic EPS”) is computed by dividing net loss by the weighted average number of common shares outstanding. Diluted net loss per common share (“Diluted EPS”) is computed by dividing net loss by the weighted average number of common shares and dilutive common share equivalents and convertible securities then outstanding. Diluted EPS for all periods presented is the same as Basic EPS, as the inclusion of the effect of common share equivalents then outstanding would be anti-dilutive. For this reason, excluded from the calculation of Diluted EPS for the nine months ended July 31, 2021 and 2020, were stock options to purchase and shares, respectively, and warrants to purchase and shares, respectively.
| 7. | EFFECT OF RECENTLY ADOPTED AND ISSUED PRONOUNCEMENTS |
In February 2016, the Financial Accounting Standards Board (FASB) issued Accounting Standards Update 2016-02 (“ASU 2016-02”) Accounting Standards Codification Topic 842, Leases (“ASC 842”), which supersedes Topic 840, Leases, and which requires lessees to recognize most leases on the balance sheet. The new lease standard does not substantially change lessor accounting. For public companies, the standard was effective for the first interim reporting period within annual periods beginning after December 15, 2018, although early adoption was permitted. Lessees and lessors were required to apply the new standard at the beginning of the earliest period presented in the financial statements in which they first apply the new guidance. In July 2018, FASB issued ASU 2018-11, Leases, which provides an additional transition option for an entity to apply the provisions of ASC 842 by recognizing a cumulative effect adjustment at the effective date of adoption without adjusting the prior comparative periods presented. The requirements of this standard include a significant increase in required disclosures. The Company adopted ASU 2016-02 on November 1, 2019. The adoption of this standard did not have a material impact on our condensed consolidated financial statements. See Note 9 regarding the accounting and disclosures related to our office lease.
In January 2020, the FASB issued Accounting Standards Update 2020-01 (“ASU 2020-01”) Investments-Equity Securities (Topic 321), Investments-Equity Method and Joint Ventures (Topic 323), and Derivatives and Hedging (Topic 815). The amendments in ASU 2020-01 clarify certain interactions between the guidance to account for certain equity securities under Topic 321, the guidance to account for investments under the equity method of accounting in Topic 323, and the guidance in Topic 815, which could change how an entity accounts for an equity security under the measurement alternative or a forward contract or purchased option to purchase securities that, upon settlement of the forward contract or exercise of the purchased option, would be accounted for under the equity method of accounting or the fair value option in accordance with Topic 825, Financial Instruments. These amendments improve current GAAP by reducing diversity in practice and increasing comparability of the accounting for these interactions. The amendments in this update are effective for fiscal years beginning after December 15, 2020, and interim periods within those fiscal years. The adoption of this standard will not have a material impact on our disclosures or consolidated financial statements.
| 17 |
| 8. | INCOME TAXES |
We recognize deferred tax assets and liabilities for the estimated future tax effects of events that have been recognized in our financial statements or tax returns. Under this method, deferred tax assets and liabilities are determined based on the difference between the financial statement and tax bases of assets and liabilities using enacted tax rates in effect in the years in which the differences are expected to reverse. A valuation allowance is established, when necessary, to reduce deferred tax assets to the amount expected to be realized. We have provided a full valuation allowance against our deferred tax asset due to our historical pre-tax losses and the uncertainty regarding the realizability of these deferred tax assets.
We have substantial net operating
loss carryforwards for Federal and California income tax returns. These net operating loss carryforwards could be subject to limitations
under Internal Revenue Code section 382. We have
| 9. | LEASES |
We lease approximately
On November 1, 2019, the Company adopted ASC 842, which increases transparency and comparability by recognizing a lessee’s rights and obligations resulting from leases by recording them on the balance sheet as lease assets and lease liabilities. The new guidance requires the recognition of the right-of-use (“ROU”) assets and related operating lease liabilities on the balance sheet. The Company adopted the new guidance using the modified retrospective approach on November 1, 2019.
For operating leases, the lease
liability is initially and subsequently measured at the present value of the unpaid lease payments. The remaining
| 18 |
Balance sheet information related to the Company’s lease is presented below:
| Balance Sheet Location | July 31, 2021 | October 31, 2020 | ||||||||
| Operating Lease: | ||||||||||
| Right-of-use asset | Operating lease right-of-use asset | $ | $ | |||||||
| Right-of-use liability, current | Operating lease liability | |||||||||
As of July 31, 2021, the annual minimum lease payments of our operating lease liabilities were as follows:
| Operating Leases | ||||
| 2021 future minimum payments, undiscounted | $ | |||
| Less: Imputed interest | ( |
) | ||
| Present value of future minimum lease payments | $ | |||
| 10. | COMMITMENTS AND CONTINGENCES |
Litigation Matters
We are not involved in any litigation or other legal proceedings and management is not aware of any pending litigation or legal proceeding against us that would have a material adverse effect upon our results of operations or financial condition.
Impact of Coronavirus Pandemic
On March 10, 2020, the World Health Organization declared the COVID-19 outbreak a pandemic. The virus and actions taken to mitigate its spread have had and are expected to continue to have a broad adverse impact on the economies and financial markets of many countries, including the geographical areas in which the Company operates and conducts its business, and which the Company’s partners operate and conduct their business. We are currently following the recommendations of local health authorities to minimize exposure risk for our team members and visitors. However, while the outlook is improving, and there has been a loosening of restrictions in many of the areas in which we and our partners operate and conduct our business, the scale and scope of this pandemic is unknown, and the duration of the business disruption and related financial impact cannot be reasonably estimated at this time. While we have implemented specific business continuity plans to reduce the potential impact of COVID-19, there is no guarantee that our continuity plans will be successful.
We have experienced certain disruptions to our business such as temporary closure of our offices and similar disruptions have occurred for our partners. Specifically, the outbreak has caused temporary shutdowns of the laboratories and other service providers that we rely on to develop our programs, and those laboratories and service providers that have been operating or that have begun operating recently have been doing so with more limited capacity due to social distancing requirements. As a result, our progress has been slowed and there is no assurance that we will be able to meet our previously announced timelines regarding the advancement of our programs.
The extent to which COVID-19 or any other health epidemic may impact our results will depend on future developments, which are highly uncertain and cannot be predicted, including new information which may emerge concerning the severity of COVID-19 and the actions to contain COVID-19 or treat its impact, among others. Accordingly, COVID-19 could have a material adverse effect on our business, results of operations, financial condition and prospects.
| 19 |
| 11. | SEGMENT INFORMATION |
We follow the accounting guidance
of ASC 280 “Segment Reporting” (“ASC 280”). Reportable operating segments are determined based on the management
approach. The management approach, as defined by ASC 280, is based on the way that the chief operating decision-maker organizes the segments
within an enterprise for making operating decisions and assessing performance. While our results of operations are primarily reviewed
on a consolidated basis, the chief operating decision-maker manages the enterprise in
| For the Three Months Ended July 31, |
For the Nine Months Ended July 31, |
|||||||||||||||
| 2021 | 2020 | 2021 | 2020 | |||||||||||||
| Net Income/(Loss): | ||||||||||||||||
| CAR-T Therapeutics | $ | ( |
) | $ | ( |
) | $ | ( |
) | $ | ( |
) | ||||
| Cancer Vaccines | ( |
) | ( |
) | ( |
) | ( |
) | ||||||||
| Anti-Viral Therapeutics | ( |
) | ( |
) | ( |
) | ( |
) | ||||||||
| Cancer Diagnostics | ( |
) | ( |
) | ( |
) | ( |
) | ||||||||
| Patent Licensing | ( |
) | ( |
) | ( |
) | ||||||||||
| Total | $ | ( |
) | $ | ( |
) | $ | ( |
) | $ | ( |
) | ||||
| Total operating costs and expenses | $ | $ | $ | $ | ||||||||||||
| Less non-cash share-based compensation | ( |
) | ( |
) | ( |
) | ( |
) | ||||||||
| Operating costs and expenses excluding non-cash share-based compensation |
$ | $ | $ | $ | ||||||||||||
| Operating costs and expenses excluding non-cash share-based compensation: |
||||||||||||||||
| CAR-T Therapeutics | $ | $ | $ | $ | ||||||||||||
| Cancer Vaccines | ||||||||||||||||
| Anti-Viral Therapeutics | ||||||||||||||||
| Cancer Diagnostics | ||||||||||||||||
| Patent Licensing | ||||||||||||||||
| Total | $ | $ | $ | |||||||||||||
| July 31, 2021 |
October 31, 2020 |
|||||||
| Total assets: | ||||||||
| CAR-T Therapeutics | $ | $ | ||||||
| Cancer Vaccines | ||||||||
| Anti-Viral Therapeutics | ||||||||
| Cancer Diagnostics | ||||||||
| Patent Licensing | ||||||||
| Total | $ | $ | ||||||
Operating costs and expenses excluding non-cash share-based compensation expense is the measurement the chief operating decision-maker uses in managing the enterprise.
| 20 |
| Item 2. | Management’s Discussion and Analysis of Financial Condition and Results of Operations. |
Information included in this Quarterly Report on Form 10-Q (this “Report”) contains forward-looking statements within the meaning of Section 27A of the Securities Act of 1933, as amended, and Section 21E of the Securities Exchange Act of 1934, as amended (the “Exchange Act”). Forward-looking statements are not statements of historical facts, but rather reflect our current expectations concerning future events and results. We generally use the words “believes,” “expects,” “intends,” “plans,” “anticipates,” “likely,” “will” and similar expressions to identify forward-looking statements. Such forward-looking statements, including those concerning our expectations, involve risks, uncertainties and other factors, some of which are beyond our control, which may cause our actual results, performance or achievements, or industry results, to be materially different from any future results, performance or achievements expressed or implied by such forward-looking statements. These risks, uncertainties and factors include, but are not limited to, those factors set forth in our Annual Report on Form 10-K for the fiscal year ended October 31, 2020 and the condensed consolidated financial statements included in this Report. Except as required by applicable law, including the securities laws of the United States, we undertake no obligation to publicly update or revise any forward-looking statements, whether as a result of new information, future events or otherwise. You are cautioned not to unduly rely on such forward-looking statements when evaluating the information presented in this Report.
GENERAL
We discuss the description of our business in the Notes to our Condensed Consolidated Financial Statements.
RESULTS OF OPERATIONS
Three months ended July 31, 2021 compared with three months ended July 31, 2020
Revenue
Over the past several years, our revenue, if any, was derived from technology licensing and the sale of patented technologies, including revenue from the settlement of litigation. We have not generated any revenue to date from our therapeutics or vaccine programs. In addition, while we pursue our therapeutics and vaccine programs, we may also make investments in and form new companies to develop additional emerging technologies. We do not expect to begin generating revenue with respect to any of our current therapy or vaccine programs in the near term. We hope to achieve a profitable outcome by eventually licensing our technologies to large pharmaceutical companies that have the resources and infrastructure in place to manufacture, market and sell our technologies as therapeutics or vaccines. The eventual licensing of any of our technologies may take several years, if it is to occur at all, and may depend on positive results from human clinical trials.
We had no revenue during the three-month periods ended July 31, 2021 and 2020.
Inventor Royalties, Contingent Legal Fees, Litigation and Licensing Expenses
We had no inventor royalties, contingent legal fees, litigation and licensing expenses during the three-month periods ended July 31, 2021 and 2020.
Research and Development Expenses
Research and development expenses incurred in the three months ended July 31, 2021 associated with each of our development programs consisted of approximately $839,000 for CAR-T therapeutics, approximately $770,000 for cancer vaccines, approximately $558,000 for anti-viral therapeutics and $-0- for cancer diagnostics.
| 21 |
Research and development expenses are related to the development of our cancer therapeutics, vaccine and diagnostics programs and our anti-viral drug program, and increased by approximately $913,000 to approximately $2,167,000 in the three months ended July 31, 2021, from approximately $1,254,000 in the three months ended July 31, 2020. The increase in research and development expenses was primarily due to an increase in employee stock option expense of approximately $1,262,000, an increase in outside research and development related to our development programs, other than our cancer diagnostics program, of approximately $263,000, an increase in consultant stock option expense of approximately $86,000, offset by a decrease in outside research and development expense related to our cancer diagnostics program of approximately $288,000, a decrease in employee compensation and related costs, other than stock option compensation expense, of approximately $200,000 and a decrease in consulting expense of approximately $108,000, all such decreases due to suspension of development of our cancer diagnostics program on July 2, 2020 and a decrease in professional fees of approximately $38,000.
General and Administrative Expenses
General and administrative expenses increased by approximately $1,040,000 to approximately $2,222,000 in the three months ended July 31, 2021, from approximately $1,182,000 in the three months ended July 31, 2020. The increase in general and administrative expenses was primarily due to an increase in employee stock option expense of approximately $447,000, an increase in director stock option expense of approximately $396,000, an increase in consulting expense of approximately $123,000, an increase in director cash compensation of approximately $63,000, an increase in corporate insurance expense of approximately $62,000, an increase in professional fees of approximately $32,000, offset by a decrease in employee compensation and related costs, other than stock option compensation expense, of approximately $100,000.
Interest Income
Interest income decreased by approximately $7,000 to less than $1,000 in the three months ended July 31, 2021, from approximately $7,000 in the comparable prior year period as a result of a decrease in interest rates.
Net Loss Attributable to Noncontrolling Interest
The net loss attributable to noncontrolling interest, representing Wistar’s 5% ownership interest in Certainty’s net loss, was approximately $54,000 and $15,000, respectively, in the three months ended July 31, 2021 and 2020.
Nine months ended July 31, 2021 compared with nine months ended July 31, 2020
Revenue
For the nine months ended July 31, 2021, we recorded revenue of approximately $513,000 from one license agreement. The license agreement provided for a one-time, non-recurring, lump sum payment in exchange for a non-exclusive retroactive and future license, and covenant not to sue. Pursuant to the terms of the agreement, we have no further obligations with respect to the granted intellectual property rights, including no obligation to maintain or upgrade the technology, or provide future support or services. Accordingly, the performance obligations from this license agreement were satisfied and 100% of the revenue was recognized upon execution of the license agreement. As discussed in Note 1 to our condensed consolidated financial statements, as part of our legacy operations, the Company remains engaged in limited patent licensing activities which we do not expect to be a significant part of our ongoing operations or revenue.
| 22 |
We had no revenue during the nine-month period ended July 31, 2020.
Inventor Royalties, Contingent Legal Fees, Litigation and Licensing Expenses
Inventor royalties, contingent legal fees, litigation and licensing expenses increased to approximately $385,000 in the nine months ended July 31, 2021 from $-0- in the nine months ended July 31, 2020. The increase was primarily due to the increase in related revenues. Inventor royalties and contingent legal fees are expensed in the period that the related revenues are recognized. Litigation and licensing expenses related to patent assertion, other than contingent legal fees, are expensed in the period incurred.
Research and Development Expenses
Research and development expenses incurred in the nine months ended July 31, 2021 associated with each of our development programs consisted of approximately $1,753,000 for CAR-T therapeutics, approximately $1,400,000 for cancer vaccines, approximately $861,000 for anti-viral therapeutics and approximately $2,000 for cancer diagnostics.
Research and development expenses are related to the development of our cancer therapeutics, vaccine and diagnostics programs and our anti-viral drug program, and increased by approximately $42,000 to approximately $4,016,000 in the nine months ended July 31, 2021, from approximately $3,974,000 in the nine months ended July 31, 2020. The increase in research and development expenses was primarily due to an increase in employee stock option expense of approximately $1,013,000, an increase in outside research and development related to our development programs, other than our cancer diagnostics program, of approximately $691,000, an increase in consultant stock option expense of approximately $161,000, offset by a decrease in outside research and development expense related to our cancer diagnostics program of approximately $1,104,000, a decrease in employee compensation and related costs, other than stock option compensation expense, of approximately $594,000 and a decrease in consulting expense of approximately $133,000, all such decreases due to suspension of development of our cancer diagnostics program.
General and Administrative Expenses
General and administrative expenses increased by approximately $1,408,000 to approximately $5,170,000 in the nine months ended July 31, 2021, from approximately $3,762,000 in the nine months ended July 31, 2020. The increase in general and administrative expenses was primarily due to an increase in director compensation of approximately $502,000, an increase in employee stock option expense of approximately $460,000, non-recurring income in the prior year period resulting from the discharge in January 2020 of a disputed liability of approximately $337,000 upon the expiration of the vendor’s statutory right to pursue collection of the disputed liability, an increase in patent expense of approximately $194,000, an increase in corporate insurance expense of approximately $109,000, an increase in consultant stock option and warrant expense of approximately $103,000, offset by a decrease in employee compensation and related costs, other than stock option compensation expense, of approximately $347,000.
Interest Income
Interest income decreased by approximately $31,000 to approximately $2,000 in the nine months ended July 31, 2021, from approximately $33,000 in the comparable prior year period as a result of a decrease in interest rates.
| 23 |
Net Loss Attributable to Noncontrolling Interest
The net loss attributable to noncontrolling interest, representing Wistar’s 5% ownership interest in Certainty’s net loss, was approximately $116,000 and $57,000, respectively, in the nine months ended July 31, 2021 and 2020.
LIQUIDITY AND CAPITAL RESOURCES
Our primary sources of liquidity are cash, cash equivalents and short-term investments.
Based on currently available information as of September 1, 2021, we believe that our existing cash, cash equivalents, short-term investments and expected cash flows will be sufficient to fund our activities for at least the next twelve months. We have implemented a business model that conserves funds by collaborating with third parties to develop our technologies. However, our projections of future cash needs and cash flows may differ from actual results. If current cash on hand, cash equivalents, short-term investments and cash that may be generated from our business operations are insufficient to continue to operate our business, or if we elect to invest in or acquire a company or companies or new technology or technologies that are synergistic with or complementary to our technologies, we may be required to obtain more working capital. During the nine months ended July 31, 2021, we raised approximately $20,292,000, net of expenses, through a public offering in which we sold an aggregate of 4,285,715 shares of common stock and approximately $10,834,000, net of expenses, through our at-the-market equity program in which we sold an aggregate of 2,806,410 shares of common stock. Our at-the-market equity program was terminated on June 16, 2021. We may seek to obtain working capital during our fiscal year 2021 or thereafter through sales of our equity securities or through bank credit facilities or public or private debt from various financial institutions where possible. We cannot be certain that additional funding will be available on acceptable terms, or at all. If we do identify sources for additional funding, the sale of additional equity securities or convertible debt will result in dilution to our stockholders. We can give no assurance that we will generate sufficient cash flows in the future to satisfy our liquidity requirements or sustain future operations, or that other sources of funding, such as sales of equity or debt, would be available or would be approved by our security holders, if needed, on favorable terms or at all. If we fail to obtain additional working capital as and when needed, such failure could have a material adverse impact on our business, results of operations and financial condition. Furthermore, such lack of funds may inhibit our ability to respond to competitive pressures or unanticipated capital needs, or may force us to reduce operating expenses, which would significantly harm the business and development of operations.
During the nine months ended July 31, 2021, cash used in operating activities was approximately $3,893,000. Cash used in investing activities was approximately $6,724,000, resulting from the purchase of short-term investments of approximately $10,400,000, which was offset by the proceeds on maturities of short-term investments of approximately $3,640,000 and the proceeds from the sale of equipment of approximately $35,000. Cash provided by financing activities was approximately $31,422,000, resulting from net proceeds of approximately $20,292,000 from a public offering of 4,285,715 shares of common stock, the sale of 2,806,410 shares of common stock in an at-the-market equity offering of approximately $10,834,000, proceeds from exercise of stock options of approximately $294,000 and proceeds from the sale of common stock pursuant to employee stock purchase plan of approximately $3,000. As a result, our cash, cash equivalents, and short-term investments at July 31, 2021 increased approximately $27,565,000 to approximately $36,622,000 from approximately $9,057,000 at the end of fiscal year 2020.
CRITICAL ACCOUNTING POLICIES
The Company’s condensed consolidated financial statements are prepared in conformity with accounting principles generally accepted in the United States of America. In preparing these financial statements, we make assumptions, judgments and estimates that can have a significant impact on amounts reported in our condensed consolidated financial statements. We base our assumptions, judgments and estimates on historical experience and various other factors that we believe to be reasonable under the circumstances. Actual results could differ materially from these estimates under different assumptions or conditions. On a regular basis, we evaluate our assumptions, judgments and estimates and make changes accordingly.
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We believe that, of the significant accounting policies discussed in Note 2 to our consolidated financial statements in our Annual Report on Form 10-K for the fiscal year ended October 31, 2020, the following accounting policies require our most difficult, subjective or complex judgments:
| ● | Revenue Recognition; and |
| ● | Stock-Based Compensation |
Revenue Recognition
Our revenue has been derived solely from technology licensing and the sale of patented technologies. Revenue is recognized upon transfer of control of intellectual property rights and satisfaction of other contractual performance obligations to licensees in an amount that reflects the consideration we expect to receive.
We follow the accounting guidance of Accounting Standards Codification 606 (“ASC 606”), Revenue from Contracts with Customers. In accordance with ASC 606 we are required to make certain judgments and estimates in connection with the accounting for revenue. Such judgments and estimates may include determining the existence of a contract and identifying each party’s rights and obligations to transfer goods and services, identifying the performance obligations in the contract, determining the transaction price and allocating the transaction price to separate performance obligations, estimating the timing of satisfaction of performance obligations, determining whether a promise to grant a license is distinct from other promised goods or services and evaluating whether a license transfers to a customer at a point in time or over time.
Our revenue arrangements provide for the payment, within 30 days of execution of the agreement, of contractually determined, one-time, paid-up license fees in settlement of litigation and in consideration for the grant of certain intellectual property rights for patented technologies owned or controlled by the Company. These arrangements typically include some combination of the following: (i) the grant of a non-exclusive, retroactive and future license to manufacture and/or sell products covered by patented technologies owned or controlled by the Company, (ii) a covenant-not-to-sue, (iii) the release of the licensee from certain claims, and (iv) the dismissal of any pending litigation. In such instances, the intellectual property rights granted have been perpetual in nature, extending until the expiration of the related patents. Pursuant to the terms of these agreements, we have no further obligations with respect to the granted intellectual property rights, including no obligation to maintain or upgrade the technology, or provide future support or services. Licensees obtained control of the intellectual property rights they have acquired upon execution of the agreement. Accordingly, the performance obligations from these agreements were satisfied and 100% of the revenue was recognized upon the execution of the agreements.
Stock-Based Compensation
The compensation cost for service-based stock options granted to employees, directors and consultants is measured at the grant date, based on the fair value of the award using the Black-Scholes pricing model, and is recognized as an expense on a straight-line basis over the requisite service period (the vesting period of the stock option) which is one to four years. For employee options vesting if the trading price of the Company’s common stock achieves certain price targets we use a Monte Carlo Simulation in estimating the fair value at grant date and recognize compensation cost over the implied service period.
For restricted stock awards vesting upon achievement of a price target of our common stock we use a Monte Carlo Simulation in estimating the fair value at grant date and recognize compensation cost over the implied service period (median time to vest).
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The Black-Scholes pricing model and the Monte Carlo Simulation we use to estimate fair value requires valuation assumptions of expected term, expected volatility, risk-free interest rates and expected dividend yield. The expected term of stock options represents the weighted average period the stock options are expected to remain outstanding. For employees we use the simplified method, which is a weighted average of the vesting term and contractual term, to determine expected term. The simplified method was adopted since we do not believe that historical experience is representative of future performance because of the impact of the changes in our operations and the change in terms from historical options. For consultants we use the contract term for expected term. Under the Black-Scholes pricing model, we estimated the expected volatility of our shares of common stock based upon the historical volatility of our share price over a period of time equal to the expected term of the grants. We estimated the risk-free interest rate based on the implied yield available on the applicable grant date of a U.S. Treasury note with a term equal to the expected term of the underlying grants. We made the dividend yield assumption based on our history of not paying dividends and our expectation not to pay dividends in the future.
We will reconsider use of the Black-Scholes pricing model and the Monte Carlo Simulation if additional information becomes available in the future that indicates another model would be more appropriate. If factors change and we employ different assumptions in future periods, the compensation expense that we record may differ significantly from what we have recorded in the current period.
EFFECT OF RECENTLY ISSUED PRONOUNCEMENTS
We discuss the effect of recently issued pronouncements in the Notes to our Condensed Consolidated Financial Statements.
Item 3. Quantitative and Qualitative Disclosures About Market Risk.
As of July 31, 2021, we had investments in short-term, fixed rate and highly liquid instruments that have historically been reinvested when they mature throughout the year. Although our existing instruments are not considered at risk with respect to changes in interest rates or markets for these instruments, our rate of return on these securities could be affected at the time of reinvestment, if any.
Item 4. Controls and Procedures.
We carried out an evaluation, under the supervision and with the participation of our management including our President and Chief Executive Officer and our Chief Operating Officer and Chief Financial Officer, of the effectiveness of the design and operation of our disclosure controls and procedures pursuant to Rule 13(a)-15(b) of the Exchange Act. Based upon that evaluation, our President and Chief Executive Officer and our Chief Operating Officer and Chief Financial Officer concluded that our disclosure controls and procedures are effective as of the end of the period covered by this Report.
There was no change in our internal control over financial reporting during the third quarter of fiscal year 2021 that has materially affected, or is reasonably likely to materially affect, our internal control over financial reporting.
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PART II. OTHER INFORMATION
Item 1. Legal Proceedings.
We are not involved in any litigation or other legal proceedings and management is not aware of any pending litigation or legal proceeding against us that would have a material adverse effect upon our results of operations or financial condition.
Item 1A. Risk Factors.
There have been no material changes in our risk factors from those disclosed in our Annual Report on Form 10-K for the fiscal year ended October 31, 2020.
Item 2. Unregistered Sales of Equity Securities and Use of Proceeds. None.
Item 3. Defaults Upon Senior Securities. None.
Item 4. Mine Safety Disclosures. Not Applicable.
Item 5. Other Information. None.
Item 6. Exhibits.
| 101.INS | Inline XBRL Instance Document | |
| 101.SCH | Inline XBRL Taxonomy Extension Schema Document | |
| 101.CAL | Inline XBRL Taxonomy Extension Calculation Linkbase Document | |
| 101.DEF | Inline XBRL Taxonomy Extension Definition Linkbase Document | |
| 101.LAB | Inline XBRL Taxonomy Extension Label Linkbase Document | |
| 101.PRE | Inline XBRL Taxonomy Extension Presentation Linkbase Document | |
| 104 | Cover Page Interactive Data File (embedded within the Inline XBRL document) |
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SIGNATURES
Pursuant to the requirements of the Securities Exchange Act of 1934, the registrant has duly caused this Report to be signed on its behalf by the undersigned, thereunto duly authorized.
| ANIXA BIOSCIENCES, INC. | ||
| By: | /s/ Dr. Amit Kumar | |
| Dr. Amit Kumar | ||
| Chairman, President and | ||
| Chief Executive Officer | ||
| September 1, 2021 | (Principal Executive Officer) | |
| By: | /s/ Michael J. Catelani | |
| Michael J. Catelani | ||
| Chief Operating Officer and | ||
| Chief Financial Officer | ||
| (Principal Financial and | ||
| September 1, 2021 | Accounting Officer) |
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