Anixa Biosciences Inc 10-Q for FY2020 Q3
Anixa Biosciences Inc (ANIX)
About this 10-Q
Anixa Biosciences Inc filed this 10-Q on September 8, 2020, covering the quarter ended July 31, 2020 (FY2020 Q3).
Headline figures
Quarter ended July 31, 2020, as reported in this filing, compared with the same period a year earlier where the filing states it.
- Net loss
- $2.56M
- compared with a net loss of $2.14M a year earlier
UNITED STATES
SECURITIES AND EXCHANGE COMMISSION
Washington, D.C. 20549
FORM 10-Q
QUARTERLY REPORT PURSUANT TO SECTION 13 OR 15(d)
OF THE SECURITIES EXCHANGE ACT OF 1934
For the quarterly period ended July 31, 2020
Commission file number 001-37492
ANIXA BIOSCIENCES, INC.
(Exact name of registrant as specified in its charter)
| Delaware | 11-2622630 | |
(State or other jurisdiction of incorporation or organization) |
(I.R.S. Employer Identification No.) |
3150 Almaden Expressway, Suite 250 San Jose, CA |
95118 | |
| (Address of principal executive offices) | (Zip Code) |
(408) 708-9808
(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 | ||
| Common Stock, par value $.01 per share | ANIX | NASDAQ Capital Market |
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.
Yes [X] No [ ]
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).
Yes [X] No [ ]
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 [ ] | |
| Non-accelerated filer [X] | Smaller reporting company [X]
|
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 [ ] No [X]
Indicate the number of shares outstanding of each of the issuer’s classes of common stock, as of the latest practicable date.
On September 8, 2020 the registrant had outstanding 23,789,386 shares of Common Stock, par value $.01 per share, which is the registrant’s only class of common stock.
TABLE OF CONTENTS
| 2 |
ANIXA BIOSCIENCES, INC. AND SUBSIDIARIES
CONDENSED CONSOLIDATED BALANCE SHEETS
| July 31, 2020 | October 31, 2019 | ||||||
| (Unaudited) | ||||||||
| ASSETS | ||||||||
| Current assets: | ||||||||
| Cash and cash equivalents | $ | 5,928,007 | $ | 3,491,625 | ||||
| Short-term investments in certificates of deposit | 3,140,000 | 2,350,000 | ||||||
| Receivables | 5,950 | 66,527 | ||||||
| Prepaid expenses and other current assets | 189,842 | 184,972 | ||||||
| Total current assets | 9,263,799 | 6,093,124 | ||||||
| Property and equipment, net of accumulated depreciation of $95,015 | - | 200,569 | ||||||
| Operating lease right-of-use asset | 67,982 | - | ||||||
| Other assets | 30,000 | - | ||||||
| Total assets | $ | 9,361,781 | $ | 6,293,693 | ||||
| LIABILITIES AND EQUITY | ||||||||
| Current liabilities: | ||||||||
| Accounts payable | $ | 339,295 | $ | 585,817 | ||||
| Accrued expenses | 815,717 | 895,498 | ||||||
| Operating lease liability | 58,195 | - | ||||||
| Total current liabilities | 1,213,207 | 1,481,315 | ||||||
| Operating lease liability, non-current | 10,567 | - | ||||||
| Total liabilities | 1,223,774 | 1,481,315 | ||||||
| Commitments and contingencies (Note 9) | ||||||||
| Equity: | ||||||||
| Shareholders’ equity: | ||||||||
| Preferred stock, par value $100 per share; 19,860 shares authorized; no shares issued or outstanding | |
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- |
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- |
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| Series A convertible preferred stock, par value $100 per share; 140 shares authorized; no shares issued or outstanding | |
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- |
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- |
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| Common stock, par value $.01 per share; 48,000,000 shares authorized; 23,653,754 and 20,331,754 shares issued and outstanding, respectively | 236,537 | 203,317 | ||||||
| Additional paid-in capital | 197,993,060 | 186,849,299 | ||||||
| Accumulated deficit | (189,611,583 | ) | (181,817,263 | ) | ||||
| Total shareholders’ equity | 8,618,014 | 5,235,353 | ||||||
| Noncontrolling interest (Note 1) | (480,007 | ) | (422,975 | ) | ||||
| Total equity | 8,138,007 | 4,812,378 | ||||||
| Total liabilities and equity | $ | 9,361,781 | $ | 6,293,693 | ||||
The accompanying notes are an integral part of these condensed consolidated financial statements.
| 3 |
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, | |||||||||||||||
| 2020 | 2019 | 2020 | 2019 | |||||||||||||
| Revenue | $ | - | $ | - | $ | - | $ | 250,000 | ||||||||
| Operating costs and expenses: | ||||||||||||||||
| Patent assertion expenses | - | - | - | 166,250 | ||||||||||||
| Amortization of patents | - | 41,875 | - | 418,750 | ||||||||||||
| Research and development expenses (including non-cash share-based compensation expenses of $394,842, $338,449, $1,250,497 and $2,567,294, respectively) | 1,254,131 | 1,085,574 | 3,973,509 | 4,602,239 | ||||||||||||
| General and administrative expenses (including non-cash share-based compensation expenses of $646,957, $492,449, $1,922,722 and $2,335,218, respectively) | 1,181,838 | 1,056,963 | 3,762,466 | 4,405,385 | ||||||||||||
| Impairment in carrying amount of patent asset | - | - | - | 418,750 | ||||||||||||
| Total operating costs and expenses | 2,435,969 | 2,184,412 | 7,735,975 | 10,011,374 | ||||||||||||
| Loss from operations | (2,435,969 | ) | (2,184,412 | ) | (7,735,975 | ) | (9,761,374 | ) | ||||||||
| Other Expense | (148,084 | ) | - | (148,084 | ) | - | ||||||||||
| Interest income | 7,266 | 18,364 | 32,707 | 53,783 | ||||||||||||
| Net loss | (2,576,787 | ) | (2,166,048 | ) | (7,851,352 | ) | (9,707,591 | ) | ||||||||
| Less: Net loss attributable to noncontrolling interest | (15,103 | ) | (26,020 | ) | (57,032 | ) | (148,030 | ) | ||||||||
| Net loss attributable to common shareholders | $ | (2,561,684 | ) | $ | (2,140,028 | ) | $ | (7,794,320 | ) | $ | (9,559,561 | ) | ||||
| Net loss per common share attributable to common shareholders: | ||||||||||||||||
| Basic and diluted | $ | (0.11 | ) | $ | (0.11 | ) | $ | (0.36 | ) | $ | (0.49 | ) | ||||
| Weighted average common shares outstanding: | ||||||||||||||||
| Basic and diluted | 23,165,066 | 20,100,915 | 21,678,608 | 19,638,833 | ||||||||||||
The accompanying notes are an integral part of these condensed consolidated financial statements.
| 4 |
ANIXA BIOSCIENCES, INC. AND SUBSIDIARIES
CONDENSED CONSOLIDATED STATEMENTS OF SHAREHOLDERS’ EQUITY (UNAUDITED)
FOR THE THREE MONTHS ENDED JULY 31, 2020
| Additional | Total | Non- | ||||||||||||||||||||||||||
| Common Stock | Paid-in | Accumulated | Shareholders’ | controlling | Total | |||||||||||||||||||||||
| Shares | Par Value | Capital | Deficit | Equity | Interest | Equity | ||||||||||||||||||||||
| Balance, April 30, 2020 | 21,479,335 | $ | 214,793 | $ | 192,122,260 | $ | (187,049,899 | ) | $ | 5,287,154 | $ | (464,904 | ) | $ | 4,822,250 | |||||||||||||
| Stock option compensation to employees and directors | - | - | 997,094 | - | 997,094 | - | 997,094 | |||||||||||||||||||||
| Stock options issued to consultants | - | - | 44,705 | - | 44,705 | - | 44,705 | |||||||||||||||||||||
| Common stock issued upon exercise of stock options | 7,200 | 72 | 18,468 | - | 18,540 | - | 18,540 | |||||||||||||||||||||
| Common stock issued in at-the-market offering, net of offering expenses of $155,776 | 2,167,219 | 21,672 | 4,810,533 | - | 4,832,205 | - | 4,832,205 | |||||||||||||||||||||
| Net loss | - | - | - | (2,561,684 | ) | (2,561,684 | ) | (15,103 | ) | (2,576,787 | ) | |||||||||||||||||
| Balance, July 31, 2020 | 23,653,754 | $ | 236,537 | $ | 197,993,060 | $ | (189,611,583 | ) | $ | 8,618,014 | $ | (480,007 | ) | $ | 8,138,007 | |||||||||||||
FOR THE THREE MONTHS ENDED JULY 31, 2019
| Additional | Total | Non- | ||||||||||||||||||||||||||
| Common Stock | Paid-in | Accumulated | Shareholders’ | controlling | Total | |||||||||||||||||||||||
| Shares | Par Value | Capital | Deficit | Equity | Interest | Equity | ||||||||||||||||||||||
| Balance, April 30, 2019 | 20,005,075 | $ | 200,050 | $ | 183,932,744 | $ | (177,589,742 | ) | $ | 6,543,052 | $ | (373,387 | ) | $ | 6,169,665 | |||||||||||||
| Stock option compensation to employees and directors | - | - | 784,246 | - | 784,246 | - | 784,246 | |||||||||||||||||||||
| Stock options and warrants issued to consultants | - | - | 46,652 | - | 46,652 | - | 46,652 | |||||||||||||||||||||
| Common stock issued upon exercise of stock options | 10,000 | 100 | 22,600 | - | 22,700 | - | 22,700 | |||||||||||||||||||||
| Common stock issued in at-the-market offering, net of offering expenses of $111,275 | 147,776 | 1,478 | 540,464 | - | 541,942 | - | 541,942 | |||||||||||||||||||||
| Net loss | - | - | - | (2,140,028 | ) | (2,140,028 | ) | (26,020 | ) | (2,166,048 | ) | |||||||||||||||||
| Balance, July 31, 2019 | 20,162,851 | $ | 201,628 | $ | 185,326,706 | $ | (179,729,770 | ) | $ | 5,798,564 | $ | (399,407 | ) | $ | 5,399,157 | |||||||||||||
The accompanying notes are an integral part of these condensed consolidated financial statements.
| 5 |
ANIXA BIOSCIENCES, INC. AND SUBSIDIARIES
CONDENSED CONSOLIDATED STATEMENTS OF SHAREHOLDERS’ EQUITY (UNAUDITED)
FOR THE NINE MONTHS ENDED JULY 31, 2020
| Additional | Total | Non- | ||||||||||||||||||||||||||
| Common Stock | Paid-in | Accumulated | Shareholders’ | controlling | Total | |||||||||||||||||||||||
| Shares | Par Value | Capital | Deficit | Equity | Interest | Equity | ||||||||||||||||||||||
| Balance, October 31, 2019 | 20,331,754 | $ | 203,317 | $ | 186,849,299 | $ | (181,817,263 | ) | $ | 5,235,353 | $ | (422,975 | ) | $ | 4,812,378 | |||||||||||||
| Stock option compensation to employees and directors | - | - | 3,016,305 | - | 3,016,305 | - | 3,016,305 | |||||||||||||||||||||
| Stock options issued to consultants | - | - | 156,914 | - | 156,914 | - | 156,914 | |||||||||||||||||||||
| Common stock issued upon exercise of stock options | 51,100 | 511 | 121,759 | - | 122,270 | - | 122,270 | |||||||||||||||||||||
| Common stock issued pursuant to employee stock purchase plan | 9,618 | 96 | 15,356 | - | 15,452 | - | 15,452 | |||||||||||||||||||||
| Common stock issued in at-the-market offering, net of offering expenses of $314,072 | 3,261,282 | 32,613 | 7,833,427 | - | 7,866,040 | - | 7,866,040 | |||||||||||||||||||||
| Net loss | - | - | - | (7,794,320 | ) | (7,794,320 | ) | (57,032 | ) | (7,851,352 | ) | |||||||||||||||||
| Balance, July 31, 2020 | 23,653,754 | $ | 236,537 | $ | 197,993,060 | $ | (189,611,583 | ) | $ | 8,618,014 | $ | (480,007 | ) | $ | 8,138,007 | |||||||||||||
FOR THE NINE MONTHS ENDED JULY 31, 2019
| Additional | Total | Non- | ||||||||||||||||||||||||||
| Common Stock | Paid-in | Accumulated | Shareholders’ | controlling | Total | |||||||||||||||||||||||
| Shares | Par Value | Capital | Deficit | Equity | Interest | Equity | ||||||||||||||||||||||
| Balance, October 31, 2018 | 18,908,632 | $ | 189,086 | $ | 175,415,931 | $ | (170,170,209 | ) | $ | 5,434,808 | $ | (251,377 | ) | $ | 5,183,431 | |||||||||||||
| Stock option compensation to employees and directors | - | - | 2,808,910 | - | 2,808,910 | - | 2,808,910 | |||||||||||||||||||||
| Stock options and warrants issued to consultants | - | - | 139,161 | - | 139,161 | - | 139,161 | |||||||||||||||||||||
| Common stock issued upon exercise of stock options | 40,000 | 400 | 102,100 | - | 102,500 | - | 102,500 | |||||||||||||||||||||
| Restricted stock award compensation to employee pursuant to stock incentive plan | - | - | 1,954,441 | - | 1,954,441 | - | 1,954,441 | |||||||||||||||||||||
| Common stock issued pursuant to employee stock purchase plan | 5,411 | 54 | 18,506 | - | 18,560 | - | 18,560 | |||||||||||||||||||||
| Common stock issued in at-the-market offering, net of offering expenses of $264,186 | 1,208,808 | 12,088 | 4,887,657 | - | 4,899,745 | - | 4,899,745 | |||||||||||||||||||||
| Net loss | - | - | - | (9,559,561 | ) | (9,559,561 | ) | (148,030 | ) | (9,707,591 | ) | |||||||||||||||||
| Balance, July 31, 2019 | 20,162,851 | $ | 201,628 | $ | 185,326,706 | $ | (179,729,770 | ) | $ | 5,798,564 | $ | (399,407 | ) | $ | 5,399,157 | |||||||||||||
The accompanying notes are an integral part of these condensed consolidated financial statements.
| 6 |
ANIXA BIOSCIENCES, INC. AND SUBSIDIARIES
CONDENSED CONSOLIDATED STATEMENTS OF CASH FLOWS (UNAUDITED)
|
For the nine months ended July 31, |
||||||||
| 2020 | 2019 | |||||||
| Cash flows from operating activities: | ||||||||
| Reconciliation of net loss to net cash used in operating activities: | ||||||||
| Net loss | $ | (7,851,352 | ) | $ | (9,707,591 | ) | ||
| Stock option compensation to employees and directors | 3,016,305 | 2,808,910 | ||||||
| Stock options and warrants issued to consultants | 156,914 | 139,161 | ||||||
| Restricted stock award compensation to employee pursuant to stock incentive plan | - | 1,954,441 | ||||||
| Depreciation of property and equipment | 38,276 | 32,990 | ||||||
| Loss on disposal of property and equipment | 148,084 | - | ||||||
| Amortization of operating lease right-of-use asset | 38,317 | - | ||||||
| Amortization of patents | - | 418,750 | ||||||
| Impairment in carrying amount of patent assets | - | 418,750 | ||||||
| Change in operating assets and liabilities: | ||||||||
| Receivables | 60,577 | 305,919 | ||||||
| Prepaid expenses and other current assets | (4,870 | ) | 45,847 | |||||
| Accounts payable | (246,522 | ) | (14,234 | ) | ||||
| Accrued expenses | (79,781 | ) | 192,672 | |||||
| Operating lease liability | (37,537 | ) | - | |||||
| Net cash used in operating activities | (4,761,589 | ) | (3,404,385 | ) | ||||
| Cash flows from investing activities: | ||||||||
| Disbursements to acquire short-term investments in certificates of deposit | (5,510,000 | ) | (2,350,000 | ) | ||||
| Proceeds from maturities of short-term investments in certificates of deposit | 4,720,000 | 2,250,000 | ||||||
| Purchase of property and equipment | (15,791 | ) | (175,457 | ) | ||||
| Net cash used in investing activities | (805,791 | ) | (275,457 | ) | ||||
| Cash flows from financing activities: | ||||||||
| Net proceeds from sale of common stock in at-the-market offering | 7,866,040 | 4,899,745 | ||||||
| Proceeds from sale of common stock pursuant to employee stock purchase plan |
15,452 | 18,560 | ||||||
| Proceeds from exercise of stock options | 122,270 | 102,500 | ||||||
| Net cash provided by financing activities | 8,003,762 | 5,020,805 | ||||||
| Net increase in cash and cash equivalents | 2,436,382 | 1,340,963 | ||||||
| Cash and cash equivalents at beginning of period | 3,491,625 | 3,055,890 | ||||||
| Cash and cash equivalents at end of period | $ | 5,928,007 | $ | 4,396,853 | ||||
| Supplemental disclosure of non-cash investing and financing activities: | ||||||||
| Operating lease right-of-use asset | $ | (106,221 | ) | $ | - | |||
| Operating lease liability | $ | 106,299 | $ | - | ||||
The accompanying notes are an integral part of these condensed consolidated financial statements.
| 7 |
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 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 viral protein functions. Our vaccine program consists of the development of a vaccine against triple negative breast cancer (“TNBC”), the most lethal form of breast cancer.
We hold an exclusive worldwide, royalty-bearing license to use certain intellectual property owned or controlled by The Cleveland Clinic Foundation (“Cleveland Clinic”) related 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, the most lethal form of the disease. A specific protein, alpha-lactalbumin, has been identified that is only present during lactation in healthy women, but reappears in many forms of breast cancer, especially TNBC. Studies have shown that vaccinating against this protein prevents breast cancer in mice. We are working with researchers at Cleveland Clinic to advance this vaccine toward human clinical testing, and we are in the process of manufacturing the vaccine and upon completion we will be prepared to file an Investigational New Drug (“IND”) application with the U.S. Food and Drug Administration (“FDA”). While we anticipate filing the IND during the third calendar quarter of 2020, we may experience delays in the vaccine manufacturing and characterization process due to the global coronavirus pandemic. We do not currently anticipate any potential delays to significantly alter our expected timeline. The IND application, after review and if approved by the FDA, will enable us to begin testing our vaccine in human subjects.
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. With respect to Certainty’s equity obligations to Wistar, Certainty issued to Wistar shares of its common stock equal to five percent (5%) of the common stock of Certainty.
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. Clinical grade materials are currently being manufactured and upon completion will undergo extensive testing. Once the materials have been successfully tested, we will be prepared to submit an IND application with the FDA. While we anticipate filing the IND by the end of calendar 2020, we may experience delays in completing the manufacturing and testing of clinical materials due to the global coronavirus pandemic. We do not currently anticipate any potential delays to significantly alter our expected timeline. The IND application, after review and approval by the FDA, will enable us to begin testing our therapy in ovarian cancer patients.
| 8 |
In April 2020, in collaboration with OntoChem GmbH (“OntoChem”), we commenced a project to discover and ultimately develop anti-viral drug candidates against COVID-19. Through this collaboration, we are utilizing 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.
While the screening process is ongoing and we anticipate discovering additional drug candidates, we have identified four compounds that could disrupt the function of a viral enzyme called an endoribonuclease, known as Non-Structural Protein-15 (“NSP-15”), and 27 compounds that target the main protease (“Mpro”) of the virus. Our in silico molecular modeling indicates that any of the NSP-15 or Mpro inhibitors might disrupt the virus’ ability to replicate in humans. The NSP-15 compounds have been synthesized and are in the process of being tested in biological assays. We are currently evaluating which of the Mpro compounds to synthesize for biological testing. The in vitro biological assays of the NSP-15 compounds are ongoing, and if the biological activity of any of these compounds is verified, they will be tested in animal studies to further evaluate their candidacy as COVID-19 therapeutics.
On July 2, 2020, we implemented a strategic realignment of our business and redirected resources to exclusively focus on the development of therapeutics and vaccines. Accordingly, we suspended operations of our subsidiary, Anixa Diagnostics Corporation, and the development of the Cchek™ artificial intelligence driven platform of non-invasive blood tests for the early detection of cancer.
Over the next several quarters, we expect the development of our breast cancer vaccine, our COVID-19 therapeutic discovery 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, 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.
Over the past several years, our revenue 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.
| 9 |
Funding and Management’s Plans
Based on currently available information as of September 8, 2020, we believe that our existing cash, cash equivalents, short-term investments and expected cash flows will be sufficient to fund our activities for 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, 2020, we raised an aggregate of approximately $7,866,000, net of expenses, through the sale of 3,261,282 shares of common stock in our at-the-market equity offerings. This included approximately $427,000, net of expenses, through the sale of 112,238 shares of common stock in an at-the market equity offering which expired in November 2019 and approximately $7,439,000, net of expenses, through the sale of 3,149,044 shares of common stock in an at-the-market equity offering under which we may issue up to $50 million of common stock. Under our current at-the-market equity program which is currently effective and may remain available for us to use in the future, we may sell an additional approximately $42,260,000 of common stock. We may seek to obtain working capital during our fiscal year 2020 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 could 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.
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, 2019. The accompanying October 31, 2019 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, 2020, and results of operations and cash flows for the interim periods represented. The results of operations for the nine months ended July 31, 2020 are not necessarily indicative of the results to be expected for the entire year.
| 10 |
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, 2020:
| Balance, October 31, 2019 | $ | (422,975 | ) | |
| Net loss attributable to noncontrolling interest | (57,032 | ) | ||
| Balance, July 31, 2020 | $ | (480,007 | ) |
Revenue Recognition
Since fiscal 2016 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.
On November 1, 2018 we adopted Accounting Standards Update 2014-09 (“ASU 2014-09”), Revenue from Contracts with Customers using the modified retrospective method. Upon adoption of ASU 2014-09 we were required to make certain judgments and estimates in connection with the accounting for revenue. Such areas 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 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. The adoption of ASU 2014-09 had no impact on revenue recognized.
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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, licensing and enforcement related research, consulting and other expenses paid to third-parties and the amortization of patent-related investment costs. These costs are included under the caption “Operating costs and expenses” in the accompanying condensed consolidated statements of operations.
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 a platform for non-invasive blood tests for early detection of cancer, developing immuno-therapy drugs against cancer, development of our breast cancer vaccine and development of anti-viral drugs candidates for COVID-19, are expensed in the consolidated financial statements in the period incurred.
2. 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 one to four years. We recorded stock-based compensation expense related to service-based stock options granted to employees and directors of approximately $3,016,000 and $2,433,000 during the nine months ended July 31, 2020 and 2019, respectively, and approximately $997,000 and $784,000 during the three months ended July 31, 2020 and 2019, respectively.
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 1,500,000 shares of common stock, to our Chairman, President and Chief Executive Officer, vesting at target trading prices of $5.00 to $8.00 per share before May 31, 2021, with implied service periods of three to seven months. In October 2018, the first tranche of 500,000 shares of market condition options became exercisable upon achieving an average closing price above $5.00 per share for twenty consecutive trading days. We recorded stock-based compensation expense related to market condition stock options granted to employees of approximately $-0- and $376,000 during the nine months ended July 31, 2020 and 2019, respectively. We did not have any market condition stock-based compensation expense during the three months ended July 31, 2020 and 2019.
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On November 1, 2018 we adopted Accounting Standards Update 2018-07 (“ASU 2018-07”) for stock options granted to consultants. Upon adoption of ASU 2018-07 we estimated the fair value of unvested service-based and performance-based stock options at the date of adoption, using the Black-Scholes pricing model. Subsequent to adoption of ASU 2018-07, future grants to consultants are measured at the grant date, based on the fair value of the award using the Black-Scholes pricing model, consistent with our policy for grants to employees and directors. In prior periods, in accordance with US GAAP, we estimated the fair value of service-based and performance-based stock options granted to consultants at each reporting period using the Black-Scholes pricing model. We recognize the fair value of stock options granted to consultants as consulting expense over the requisite or implied service period of the grant. We recorded stock-based consulting expense related to stock options granted to consultants of approximately $157,000 and $75,000 during the nine months ended July 31, 2020 and 2019, respectively, and approximately $45,000 and $25,000 during the three months ended July 31, 2020 and 2019, respectively.
Stock Option Plans
During the nine months ended July 31, 2020, we had three stock option plans: the Anixa Biosciences, Inc. 2003 Share Incentive Plan (the “2003 Share Plan”), 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 April 21, 2003, July 14, 2010 and January 25, 2018, respectively. The 2018 Share Plan was approved by our shareholders on March 29, 2018.
Stock Option Activity
During the nine months ended July 31, 2020 and 2019, we granted options to purchase 800,000 shares and 10,000 shares of common stock, respectively, to employees and consultants, with exercise prices ranging from $3.64 to $4.04 per share, pursuant to the 2010 Share Plan and the 2018 Share Plan. During the nine months ended July 31, 2020 and 2019, stock options to purchase 51,100 and 40,000 shares of common stock, respectively, were exercised with aggregate proceeds of approximately $122,000 and $103,000, respectively.
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2003 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. Information regarding the 2003 Share Plan for the nine months ended July 31, 2020 is as follows:
| Shares | Weighted Average Exercise Price Per Share | Aggregate Intrinsic Value | ||||||||||
| Options outstanding at October 31, 2019 | 400 | $ | 17.00 | |||||||||
| Forfeited/Expired | (400 | ) | $ | 17.00 | ||||||||
| Options outstanding and exercisable at July 31, 2020 | - | $ | -0- | $ | -0- | |||||||
Information regarding the 2003 Share Plan for the nine months ended July 31, 2019 is as follows:
| Shares | Weighted Average Exercise Price Per Share | Aggregate Intrinsic Value | ||||||||||
| Options outstanding at October 31, 2018 | 12,000 | $ | 2.77 | |||||||||
| Exercised | (4,000 | ) | $ | 3.63 | ||||||||
| Options outstanding and exercisable at July 31, 2019 | 8,000 | $ | 2.34 | $ | 23,694 | |||||||
The following table summarizes information about stock options outstanding and exercisable under the 2003 Share Plan as of July 31, 2019:
| Range of Exercise Prices | Number Outstanding and Exercisable | Weighted Average Remaining Contractual Life (in years) | Weighted Average Exercise Price | |||||||||
| $0.67 - $17.00 | 8,000 | 0.19 | $ | 2.34 | ||||||||
2010 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. Information regarding the 2010 Share Plan for the nine months ended July 31, 2020 is as follows:
| Shares | Weighted Average Exercise Price Per Share | Aggregate Intrinsic Value | ||||||||||
| Options outstanding at October 31, 2019 | 1, 1,998,668 | $ | 2.80 | |||||||||
| Exercised | (51,100 | ) | $ | 2.39 | ||||||||
| Forfeited/Expired | (20,534 | ) | $ | 1.72 | ||||||||
| Options outstanding at July 31, 2020 | 1 1,927,034 | $ | 2.82 | $ | 731,670 | |||||||
| Options exercisable at July 31, 2020 | 1, 1,772,034 | $ | 2.84 | $ | 630,120 | |||||||
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The following table summarizes information about stock options outstanding and exercisable under the 2010 Share Plan as of July 31, 2020:
Options Outstanding | Options Exercisable | |||||||||||||||||||||||
| Range of Exercise Prices | Number Outstanding | Weighted (in years) | Weighted Average Exercise Price | Number Exercisable | Weighted (in years) | Weighted Average Exercise Price | ||||||||||||||||||
| $ 0.67 - $2.30 | 549,000 | 5.70 | $ | 1.57 | 494,000 | 5.56 | $ | 1.64 | ||||||||||||||||
| $ 2.58 - $ 3.13 | 846,000 | 3.05 | $ | 2.79 | 846,000 | 3.41 | $ | 2.79 | ||||||||||||||||
| $ 3.46 - $ 5.75 | 532,034 | 7.45 | $ | 4.16 | 432,034 | 7.33 | $ | 4.33 | ||||||||||||||||
Information regarding the 2010 Share Plan for the nine months ended July 31, 2019 is as follows:
| Shares | Weighted Average Exercise Price Per Share | Aggregate Intrinsic Value | ||||||||||
| Options outstanding at October 31, 2018 | 2,131,868 | $ | 2.11 | |||||||||
| Granted | 10,000 | $ | 3.64 | |||||||||
| Exercised | (32,000 | ) | $ | 2.27 | ||||||||
| Forfeited/Expired | (99,200 | ) | $ | 3.78 | ||||||||
| Options outstanding at July 31, 2019 | 2,010,668 | $ | 2.03 | $ | 5,422,886 | |||||||
| Options exercisable at July 31, 2019 | 1,639,556 | $ | 1.92 | $ | 4,609,165 | |||||||
The following table summarizes information about stock options outstanding and exercisable under the 2010 Share Plan as of July 31, 2019:
| 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 | ||||||||||||||||||
| $ 0.67 | 938,000 | 5.94 | $ | 0.67 | 799,388 | 5.59 | $ | 0.67 | ||||||||||||||||
| $2.27 -$3.01 | 600,134 | 3.81 | $ | 2.58 | 600,134 | 3.81 | $ | 2.58 | ||||||||||||||||
| $3.46 -$7.00 | 472,534 | 8.51 | $ | 4.05 | 240,034 | 8.19 | $ | 4.43 | ||||||||||||||||
2018 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, 2020, the 2018 Share Plan had 2,258,376 shares available for future grants. Information regarding the 2018 Share Plan for the nine months ended July 31, 2020 is as follows:
| Shares | Weighted Average Exercise Price Per Share | Aggregate Intrinsic Value | ||||||||||
| Options outstanding at October 31, 2019 | 3,935,000 | $ | 3.74 | |||||||||
| Granted | 800,000 | $ | 3.85 | |||||||||
| Forfeited/Expired | (258,376 | ) | $ | 3.86 | ||||||||
| Options outstanding at July 31, 2020 | 4,476,624 | $ | 3.76 | $ | -0- | |||||||
| Options exercisable at July 31, 2020 | 2,403,014 | $ | 3.76 | $ | -0- | |||||||
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The following table summarizes information about stock options outstanding and exercisable under the 2018 Share Plan as of 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 | ||||||||||||||||||||
| $ | 3.70 | 3,100,000 | 7.78 | $ | 3.70 | 1,700,000 | 7.78 | $ | 3.70 | |||||||||||||||||
| $ | 3.84 - $4.61 | 1,376,624 | 7.55 | $ | 3.89 | 703,014 | 6.15 | $ | 3.90 | |||||||||||||||||
Information regarding the 2018 Share Plan for the nine months ended July 31, 2019 is as follows:
| Shares | Weighted Average Exercise Price Per Share | Aggregate Intrinsic Value | ||||||||||
| Options outstanding at October 31, 2018 | 3,482,000 | $ | 3.73 | |||||||||
| Exercised | (4,000 | ) | $ | 3.84 | ||||||||
| Forfeited/Expired | (8,000 | ) | $ | 3.84 | ||||||||
| Options outstanding at July 31, 2019 | 3,470,000 | $ | 3.73 | $ | 3,337,300 | |||||||
| Options exercisable at July 31, 2019 | 1,321,111 | $ | 3.73 | $ | 1,273,443 | |||||||
The following table summarizes information about stock options outstanding and exercisable under the 2018 Share Plan as of July 31, 2019:
| 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 | ||||||||||||||||||||
| $ | 3.70 - $4.61 | 3,470,000 | 8.78 | $ | 3.73 | 1,321,111 | 8.77 | $ | 3.73 | |||||||||||||||||
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Outside of Share Plans
In addition to options granted under the 2003 Share Plan, the 2010 Share Plan and the 2018 Share Plan, during the years ended October 31, 2012 and 2013, the Board of Directors approved the grant of stock options to certain employees and directors. Information regarding stock options that were granted outside of Share Plans for the nine months ended July 31, 2020 is as follows:
| Shares | Weighted Average Exercise Price Per Share | Aggregate Intrinsic Value | ||||||||||
| Options outstanding at October 31, 2019 | 1,698,000 | $ | 2.58 | |||||||||
| Options outstanding and exercisable at July 31, 2020 | 1,698,000 | $ | 2.58 | $ | 348,090 | |||||||
The following table summarizes information about stock options outstanding and exercisable that were granted outside of Share Plans as of July 31, 2020:
| Range
of Exercise Prices | Number and Exercisable | Weighted
Average (in years) | Weighted
Average Exercise Price | |||||||||||
| $ | 2.58 | 1,698,000 | 2.00 | $ | 2.58 | |||||||||
Information regarding stock options that were granted outside of Share Plans for the nine months ended July 31, 2019 is as follows:
| Shares | Weighted Average Exercise Price Per Share | Aggregate Intrinsic Value | ||||||||||
| Options outstanding at October 31, 2018 | 1,780,000 | $ | 1.58 | |||||||||
| Options outstanding and exercisable at July 31, 2019 | 1,780,000 | $ | 1.58 | $ | 5,583,900 | |||||||
The following table summarizes information about stock options outstanding and exercisable that were granted outside of Share Plans as of July 31, 2019:
Range of Exercise Prices | Number and Exercisable | Weighted
Average (in years) | Weighted
Average Exercise Price | |||||||||||
| $ | 0.67 | 1,046,000 | 3.30 | $ | 0.67 | |||||||||
| $ | 2.58-$ 5.56 | 734,000 | 2.85 | $ | 2.88 | |||||||||
Stock Awards
For stock awards granted to employees, directors and consultants that vest upon grant we recognize expense at the date of grant based on the grant date market price of the underlying common stock. We did not grant any stock awards that vested upon grant during the nine months ended July 31, 2020 or 2019.
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On May 8, 2018, a restricted stock award of 1,500,000 shares of common stock was granted under the 2018 Share Plan to our Chairman, President and Chief Executive Officer. The restricted stock award vests in its entirety upon achievement of a target trading price of $11.00 per share of the Company’s common stock before May 31, 2021. 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). During the nine-month and three-month periods ended July 31, 2019, we recorded compensation expense related to the restricted stock award of approximately $1,954,000 and $-0-, respectively. We did not record any compensation expense related to the restricted stock award during the nine-month period ended July 31, 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 85% 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, 2020, employees purchased 9,618 shares with aggregate proceeds of approximately $15,000. During the nine months ended July 31, 2019, employees purchased 5,411 shares with aggregate proceeds of approximately $19,000.
Warrants
During the nine months ended July 31, 2019 we issued a warrant, expiring on November 1, 2023, to purchase 25,000 shares of common stock at $4.04 per share, vesting over 12 months, to a consultant for investor relations services. On November 1, 2019 the warrant was exchanged for a stock option with the same terms as the warrant. During the nine-month and three-month periods ended July 31, 2019, we recorded consulting expense of approximately $64,000 and $21,000, respectively, based on the fair value of the warrant recognized on a straight-line basis over the vesting period. No warrants were issued during the nine months ended July 31, 2020.
As of July 31, 2020, we also had warrants outstanding to purchase 500,000 shares of common stock at $5.03 per share expiring on November 30, 2021.
3. 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.
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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, 2020:
| Level 1 | Level 2 | Level 3 | Total | |||||||||||||
| Money market funds: | ||||||||||||||||
| Cash and cash equivalents | $ | 5,154,304 | $ | - | $ | - | $ | 5,154,304 | ||||||||
| Certificates of deposit: | ||||||||||||||||
| Cash and cash equivalents | 500,000 | 500,000 | ||||||||||||||
| Short-term investments | - | 3,140,000 | - | 3,140,000 | ||||||||||||
| Total financial assets | $ | 5,654,304 | $ | 3,140,000 | $ | - | $ | 8,794,304 | ||||||||
The following table presents the hierarchy for our financial assets measured at fair value on a recurring basis as of October 31, 2019:
| Level 1 | Level 2 | Level 3 | Total | |||||||||||||
| Money market funds: | ||||||||||||||||
| Cash and cash equivalents | $ | 2,706,944 | $ | - | $ | - | $ | 2,706,944 | ||||||||
| Certificates of deposit: | ||||||||||||||||
| Cash and cash equivalents | 500,000 | - | - | 500,000 | ||||||||||||
| Short-term investments | - | 2,350,000 | - | 2,350,000 | ||||||||||||
| Total financial assets | $ | 3,206,944 | $ | 2,350,000 | $ | - | $ | 5,556,944 | ||||||||
Our non-financial assets that are measured on a non-recurring basis include our property and equipment and which are measured using fair value techniques whenever events or changes in circumstances indicate a condition of impairment exists. The estimated fair value of accounts receivable, prepaid expenses, 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.
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4. ACCRUED EXPENSES
Accrued expenses consist of the following as of:
| July 31, 2020 | October 31, 2019 | |||||||
| Payroll and related expenses | $ | 238,565 | $ | 72,850 | ||||
| Accrued royalty and contingent legal fees | 449,691 | 449,691 | ||||||
| Accrued collaborative research and license expenses | 37,114 | 371,710 | ||||||
| Accrued severance costs | 83,624 | - | ||||||
| Accrued other | 6,723 | 1,247 | ||||||
| $ | 815,717 | $ | 895,498 | |||||
5. 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 and three months ended July 31, 2020 and 2019, were stock options to purchase 8,101,658 and 7,268,668 shares, respectively, and warrants to purchase 500,000 and 545,000 shares, respectively.
6. 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 8 regarding the accounting and disclosures related to our office lease.
7. 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.
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We have substantial net operating loss carryforwards for Federal, New York State and California income tax returns. These net operating loss carryforwards could be subject to limitations under Internal Revenue Code section 382. We have no unrecognized income tax benefits as of July 31, 2020 and October 31, 2019 and we account for interest and penalties related to income tax matters, if any, in general and administrative expenses.
8. LEASES
We lease approximately 2,000 square feet of office space at 3150 Almaden Expressway, San Jose, California (our principal executive offices) from an unrelated party pursuant to an operating lease that expires September 30, 2021. Our base rent is approximately $5,000 per month and the lease provides for annual increases of approximately 3% and an escalation clause for increases in certain operating costs. Under an operating lease that expired on May 31, 2019 we also leased approximately 3,000 square feet of office space at 12100 Wilshire Boulevard, Los Angeles, California (our former executive offices) from an unrelated party. As of August 1, 2018, we had subleased these facilities. Rent expense was approximately $48,000 and $46,000, respectively, for the nine months ended July 31, 2020 and 2019, and approximately $16,000 and $16,000, respectively, for the three months ended July 31, 2020 and 2019.
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. As a result, the condensed consolidated balance sheet as of October 31, 2019 was not restated and is not comparative.
The adoption of ASC 842 resulted in the recognition of ROU assets of $106,221, and lease liabilities for operating leases of $106,299 on the Company’s condensed consolidated balance sheet as of November 1, 2019. The difference between the ROU assets and the operating lease liability represents the difference between the lease cost and the amount of rent paid in October.
The Company elected the package of practical expedients permitted within the standard, which allow an entity to forgo reassessing (i) whether a contract contains a lease, (ii) classification of leases, and (iii) whether capitalized costs associated with a lease meet the definition of initial direct costs. Also, the Company elected the expedient allowing an entity to use hindsight to determine the lease term and impairment of ROU assets and the expedient to allow the Company to not have to separate lease and non-lease components. The Company has also elected the short-term lease accounting policy under which Anixa would not recognize a lease liability or ROU asset for any lease that at the commencement date has a lease term of twelve months or less and does not include a purchase option that Anixa is more than reasonably certain to exercise.
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For operating leases, the lease liability is initially and subsequently measured at the present value of the unpaid lease payments. The remaining 14-month lease term as of July 31, 2020 for the Company’s lease includes the noncancelable period of the lease. The lease does not contain a Company option to extend the lease or an option to extend the lease controlled by the lessor. All ROU assets are reviewed for impairment.
Balance sheet information related to the Company’s lease is presented below:
| Balance Sheet Location | July 31, 2020 | November 1, 2019 | October 31, 2019 | |||||||||||
| Operating Lease: | ||||||||||||||
| Right-of-use asset | Operating lease right-of-use asset | $ | 67,982 | $ | 106,221 | $ | - | |||||||
| Right-of-use liability, current | Operating lease liability | 58,195 | 51,101 | - | ||||||||||
| Right-of-use liability, non-current | Operating lease liability, non-current | 10,567 | 55,198 | - | ||||||||||
As of July 31, 2020, the annual minimum lease payments of our operating lease liabilities were as follows:
For Years Ending October 31, | Operating Leases | |||
| 2020 (excluding the nine months ended July 31, 2020) | $ | 15,816 | ||
| 2021 | 59,136 | |||
| Total future minimum payments, undiscounted | 74,952 | |||
| Less: Imputed interest | (6,190 | ) | ||
| Present value of future minimum lease payments | $ | 68,762 | ||
9. COMMITMENT 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.
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10. 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 five reportable segments, each with different operating and potential revenue generating characteristics: (i) CAR-T Therapeutics, (ii) Cancer Vaccines, (iii) Anti-Viral Therapeutics, (iv) Cancer Diagnostics and (v) our legacy Patent Licensing activities. The following represents selected financial information for our segments for the three and nine months ended July 31, 2020 and 2019 and as of July 31, 2020 and October 31, 2019:
| For the Three Months Ended July 31, | For the Nine Months Ended July 31, | |||||||||||||||
| 2020 | 2019 | 2020 | 2019 | |||||||||||||
| Net Loss: | ||||||||||||||||
| CAR-T Therapeutics | $ | (402,223 | ) | $ | (723,128 | ) | $ | (1,527,586 | ) | $ | (4,240,347 | ) | ||||
| Cancer Vaccines | (172,881 | ) | (573,005 | ) | (538,748 | ) | (573,005 | ) | ||||||||
| Anti-Viral Therapeutics | (268,704 | ) | - | (578,208 | ) | - | ||||||||||
| Cancer Diagnostics | (1,727,256 | ) | (876,667 | ) | (5,196,929 | ) | (3,929,021 | ) | ||||||||
| Patent Licensing | (5,723 | ) | 6,752 | (9,881 | ) | (965,218 | ) | |||||||||
| Total | $ | (2,576,787 | ) | $ | (2,166,048 | ) | $ | (7,851,352 | ) | $ | (9,707,591 | ) | ||||
| Total operating costs and expenses | $ | 2,584,053 | $ | 2,184,412 | $ | 7,884,059 | $ | 10,011,374 | ||||||||
| Less non-cash share-based compensation | (1,041,799 | ) | (830,898 | ) | (3,173,219 | ) | (4,902,512 | ) | ||||||||
| Operating costs and expenses excluding non-cash share-based compensation | $ | 1,542,254 | $ | 1,353,514 | $ | 4,710,840 | $ | 5,108,862 | ||||||||
| Operating costs and expenses excluding non-cash share based compensation: | ||||||||||||||||
| CAR-T Therapeutics | $ | 182,007 | $ | 442,621 | $ | 752,170 | $ | 1,688,301 | ||||||||
| Cancer Vaccines | 70,061 | 407,010 | 235,391 | 407,010 | ||||||||||||
| Anti-Viral Therapeutics | 149,075 | - | 370,093 | - | ||||||||||||
| Cancer Diagnostics | 1,136,629 | 487,169 | 3,345,441 | 1,905,137 | ||||||||||||
| Patent Licensing | 4,482 | 16,714 | 7,745 | 1,108,414 | ||||||||||||
| Total | $ | 1,542,254 | $ | 1,353,514 | 4,710,840 | $ | 5,108,862 | |||||||||
| July 31, 2020 | October 31, 2019 | |||||||
| Total assets: | ||||||||
| CAR-T Therapeutics | $ | 4,110,341 | $ | 2,382,460 | ||||
| Cancer Vaccines | 1,575,525 | 489,881 | ||||||
| Anti-Viral Therapeutics | 3,349,814 | - | ||||||
| Cancer Diagnostics | 78,723 | 3,119,246 | ||||||
| Patent Licensing | 247,378 | 302,106 | ||||||
| Total | $ | 9,361,781 | $ | 6,293,693 | ||||
Operating costs and expenses excluding non-cash share-based compensation expense is the measurement the chief operating decision-maker uses in managing the enterprise.
11. 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, 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 already 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 shutdowns of the laboratories and other service providers that we rely on to develop our CAR-T and breast cancer vaccine 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 IND filings for our CAR-T therapy for ovarian cancer and for our breast cancer vaccine.
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.
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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, 2019 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
Nine months ended July 31, 2020 compared with nine months ended July 31, 2019
Revenue
We did not record any revenue for the nine months ended July 31, 2020. For the nine months ended July 31, 2019, we recorded revenue of $250,000 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.
Patent assertion expenses
Patent assertion expenses decreased from approximately $166,000 in the nine months ended July 31, 2019 to $-0- in the nine months ended July 31, 2020. The decrease was primarily due to the decrease 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.
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Amortization of Patents
Amortization of patents was $-0- in the nine months ended July 31, 2020 compared to approximately $419,000 in the comparable prior year. We capitalize patent and patent rights acquisition costs and amortize the cost over the estimated economic useful life. The decrease in amortization of patents was due to the patent asset being fully amortized in fiscal year 2019.
Research and Development Expenses
Research and development expenses are related to the development of our cancer diagnostics and therapeutics programs and our anti-viral drug program, and decreased by approximately $628,000 to approximately $3,974,000 in the nine months ended July 31, 2020, from approximately $4,602,000 in the nine months ended July 31, 2019. The decrease in research and development expenses was primarily due to a decrease in employee stock award compensation expense of approximately $1,251,000 and a decrease in employee stock option compensation expense of approximately $75,000, offset by an increase in outside research and development expense, excluding license expense, of approximately $406,000 primarily related to the development of Cchek™, our non-invasive blood tests for early detection of cancer, an increase in employee compensation and related costs, other than stock option compensation expense and stock awards of approximately $136,000 and an increase in consulting expense related to our Cchek™ program of approximately $129,000.
Research and development expenses incurred in the nine months ended July 31, 2020 associated with each of our development programs consisted of approximately $2,578,000 for cancer diagnostics, approximately $798,000 for CAR-T therapeutics, approximately $329,000 for anti-viral therapeutics, and approximately $269,000 for cancer vaccines.
General and Administrative Expenses
General and administrative expenses decreased by approximately $643,000 to approximately $3,762,000 in the nine months ended July 31, 2020, from approximately $4,405,000 in the nine months ended July 31, 2019. The decrease in general and administrative expenses in 2020 was principally due to a decrease in employee stock award compensation expense of approximately $704,000, a decrease in legal and accounting fees of approximately $338,000 in fiscal year 2020 primarily related to fees incurred in fiscal year 2019 in connection with a putative shareholder derivative complaint which was settled in August 2019, a decrease in expense 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 which reduced expenses in fiscal year 2020, a decrease in expense resulting from a patent expense reimbursement to Cleveland Clinic of approximately $164,000 in fiscal 2019 which reduced expenses in fiscal year 2020 and a decrease in investor relations and public relations expense of approximately $80,000, offset by an increase in employee compensation and related costs, other than stock option compensation expense and stock award compensation expense, of approximately $502,000 which included approximately $157,000 of severance costs related to the suspension of the Cchek™ liquid biopsy program, an increase in employee stock option expense of approximately $283,000, an increase in corporate insurance expense of approximately $156,000 primarily due to an increase in directors and officers insurance premium and an increase in consultant stock option expense of approximately $73,000.
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Impairment in Carrying Amount of Patent Assets
The impairment in carrying amount of patent assets related to our legacy patent licensing activities of approximately $419,000 in the nine months ended July 31, 2019 resulted from the write down of the value of our patent assets to the estimated undiscounted future cash flows we anticipated receiving from the patent assets as of January 31, 2019. Our estimates of future cash flows were based on our most recent assessment of the market for potential licensees, as well as the status of ongoing negotiations with potential licensees.
Other Expense
Other expense was $148,000 in the nine months ended July 31, 2020 compared to $-0- in the comparable prior year. Other expense in fiscal year 2020 represents loss on disposal of property and equipment.
Interest Income
Interest income decreased by approximately $21,000 to approximately $33,000 in the nine months ended July 31, 2020, from approximately $54,000 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, decreased by approximately $91,000 to approximately $57,000 in the nine months ended July 31, 2020, from approximately $148,000 in the nine months ended July 31, 2019, as Certainty’s net loss decreased. The decrease in Certainty’s net loss was primarily due to decreases in employee stock option compensation expense and employee stock award compensation expense.
Three months ended July 31, 2020 compared with three months ended July31, 2019
Revenue
We had no revenue during the three-month periods ended July 31, 2020 and 2019.
Amortization of Patents
Amortization of patents was $-0- in the three months ended July 31, 2020 compared to approximately $42,000 in the comparable prior year. We capitalize patent and patent rights acquisition costs and amortize the cost over the estimated economic useful life. The decrease in amortization of patents was due to the patent asset being fully amortized in fiscal year 2019.
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Research and Development Expenses
Research and development expenses are related to the development of our cancer diagnostics and therapeutics programs and our anti-viral drug program, and increased by approximately $168,000 to approximately $1,254,000 in the three months ended July 31, 2020, from approximately $1,086,000 in the three months ended July 31, 2019. The increase in research and development expenses was primarily due to an increase in consulting expense of approximately $108,000 related to our Cchek™ liquid biopsy program, an increase in employee compensation and related costs, other than stock option compensation expense and stock award compensation expense, of approximately $94,000, an increase in employee stock option expense of approximately $54,000, offset by a decrease of approximately $100,000 of license fees paid to Cleveland Clinic.
Research and development expenses incurred in the three months ended July 31, 2020 associated with each of our development programs consisted of approximately $749,000 for cancer diagnostics, approximately $233,000 for CAR-T therapeutics, approximately $173,000 for anti-viral therapeutics, and approximately $99,000 for cancer vaccines.
General and Administrative Expenses
General and administrative expenses increased by approximately $125,000 to approximately $1,182,000 in the three months ended July 31, 2020, from approximately $1,057,000 in the three months ended July 31, 2019. The increase in general and administrative expenses in fiscal year 2020 was principally due to an increase in employee compensation and related costs, other than stock option compensation expense and stock award compensation expense, of approximately $174,000 which included approximately $157,000 of severance costs related to the suspension of the Cchek™ liquid biopsy program, an increase in employee stock option compensation expense of approximately $159,000, an increase in legal and accounting fees of approximately $101,000, offset by a decrease in expense resulting from a patent expense reimbursement to Cleveland Clinic of approximately $164,000 in fiscal 2019 which reduced expenses in fiscal year 2020 and a decrease in consulting expense of approximately $118,000 primarily related to commercialization of the Cchek™ program.
Other Expense
Other expense was $148,000 in the three months ended July 31, 2020 compared to $-0- in the comparable prior year. Other expense in fiscal year 2020 represents loss on disposal of property and equipment.
Interest Income
Interest income decreased by approximately $11,000 to approximately $7,000 in the three months ended July 31, 2020, from approximately $18,000 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, decreased by approximately $11,000 to approximately $15,000 in the three months ended July 31, 2020, from approximately $26,000 in the three months ended July 31, 2019, as Certainty’s net loss decreased. The decrease in Certainty’s net loss was primarily due to decreases in employee stock option compensation expense and employee stock award compensation expense.
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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 8, 2020, we believe that our existing cash, cash equivalents, short-term investments and expected cash flows will be sufficient to fund our activities for 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, 2020, we raised an aggregate of approximately $7,866,000, net of expenses, through the sale of 3,261,282 shares of common stock in our at-the-market equity offerings. This included approximately $427,000, net of expenses, through the sale of 112,238 shares of common stock in an at-the market equity offering which expired in November 2019 and approximately $7,439,000, net of expenses, through the sale of 3,149,044 shares of common stock in an at-the-market equity offering under which we may issue up to $50 million of common stock. Under our current at-the-market equity program which is currently effective and may remain available for us to use in the future, we may sell an additional approximately $42,260,000 of common stock. We may seek to obtain working capital during our fiscal year 2020 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 could 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, 2020, cash used in operating activities was approximately $4,762,000. Cash used in investing activities was approximately $806,000, resulting from the purchased of certificates of deposit totaling $5,510,000 and the purchase of property and equipment of approximately $16,000, which was offset by the proceeds on maturities of certificates of deposit totaling $4,720,000. Cash provided by financing activities was approximately $8,004,000, resulting from the sale of 3,261,282 shares of common stock in our at-the-market equity offering over the past nine months of approximately $7,866,000 (which is ongoing), the proceeds from sale of common stock pursuant to employee stock purchase plan of approximately $15,000 and the proceeds from exercise of stock options of approximately $122,000. As a result, our cash, cash equivalents, and short-term investments at July 31, 2020 increased approximately $3,226,000 to approximately $9,068,000 from approximately $5,842,000 at the end of fiscal year 2019.
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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.
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, 2019, 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.
On November 1, 2018 we adopted Accounting Standards Update 2014-09 (“ASU 2014-09”), Revenue from Contracts with Customers using the modified retrospective method. Upon adoption of ASU 2014-09 we are required to make certain judgments and estimates in connection with the accounting for revenue. Such areas 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 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. The adoption of ASU 2014-09 had no impact on revenue recognized.
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Stock-Based Compensation
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 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 exceeds 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 stock awards granted to employees and directors that vest at date of grant we recognize expense based on the grant date market price of the underlying common stock. 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).
On November 1, 2018 we adopted Accounting Standards Update 2018-07 (“ASU 2018-027”) for stock-based compensation to non-employees. Upon adoption of ASU 2018-07 we estimated the fair value of unvested awards at the date of adoption, using the Black-Scholes pricing model. Future grants to consultants will be measured at the grant date, based on the fair value of the award using the Black-Scholes pricing model, consistent with our policy for grants to employees and directors.
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. 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. 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 Monte Carlo Simulation if additional information becomes available in the future that indicates other models 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.
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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, 2020, 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 13-15(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 2020 that has materially affected, or is reasonably likely to materially affect, our internal control over financial reporting.
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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.
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, 2019 and in our Quarterly Report on Form 10-Q for the quarterly period ended April 30, 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.
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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 8, 2020 | (Principal Executive Officer) | |
| By: | /s/ Michael J. Catelani | |
| Michael J. Catelani | ||
| Chief Operating Officer and | ||
| Chief Financial Officer | ||
| September 8, 2020 | (Principal Financial and Accounting Officer) | |
| 33 |
Exhibit 31.1
CERTIFICATION
I, Dr. Amit Kumar, certify that:
| 1. | I have reviewed this quarterly report on Form 10-Q of Anixa Biosciences, Inc.; |
| 2. | Based on my knowledge, this report does not contain any untrue statement of a material fact or omit to state a material fact necessary to make the statements made, in light of the circumstances under which such statements were made, not misleading with respect to the period covered by this report; |
| 3. | Based on my knowledge, the financial statements, and other financial information included in this report, fairly present in all material respects the financial condition, results of operations and cash flows of the registrant as of, and for, the periods presented in this report; |
| 4. | The registrant’s other certifying officer(s) and I are responsible for establishing and maintaining disclosure controls and procedures (as defined in Exchange Act Rules 13a-15(e) and 15d-15(e)) and internal control over financial reporting (as defined in Exchange Act Rules 13a-15(f) and 15d-15(f)) for the registrant and have: |
| (a) | Designed such disclosure controls and procedures, or caused such disclosure controls and procedures to be designed under our supervision, to ensure that material information relating to the registrant, including its consolidated subsidiaries, is made known to us by others within those entities, particularly during the period in which this report is being prepared; |
| (b) | Designed such internal control over financial reporting, or caused such internal control over financial reporting to be designed under our supervision, to provide reasonable assurance regarding the reliability of financial reporting and the preparation of financial statements for external purposes in accordance with generally accepted accounting principles; |
| (c) | Evaluated the effectiveness of the registrant’s disclosure controls and procedures and presented in this report our conclusions about the effectiveness of the disclosure controls and procedures, as of the end of the period covered by this report based on such evaluation; and |
| (d) | Disclosed in this report any change in the registrant’s internal control over financial reporting that occurred during the registrant’s most recent fiscal quarter (the registrant’s fourth fiscal quarter in the case of an annual report) that has materially affected, or is reasonably likely to materially affect, the registrant’s internal control over financial reporting; and |
| 5. | The registrant’s other certifying officer(s) and I have disclosed, based on our most recent evaluation of internal control over financial reporting, to the registrant’s auditors and the audit committee of the registrant’s board of directors (or persons performing the equivalent functions): |
| (a) | All significant deficiencies and material weaknesses in the design or operation of internal control over financial reporting which are reasonably likely to adversely affect the registrant’s ability to record, process, summarize and report financial information; and |
| (b) | Any fraud, whether or not material, that involves management or other employees who have a significant role in the registrant’s internal control over financial reporting. |
| By: | /s/ Dr. Amit Kumar | |
| Dr. Amit Kumar | ||
| Chairman, President and | ||
| Chief Executive Officer | ||
| September 8, 2020 | (Principal Executive Officer) |
Exhibit 31.2
CERTIFICATION
I, Michael J. Catelani, certify that:
| 1. | I have reviewed this quarterly report on Form 10-Q of Anixa Biosciences, Inc.; |
| 2. | Based on my knowledge, this report does not contain any untrue statement of a material fact or omit to state a material fact necessary to make the statements made, in light of the circumstances under which such statements were made, not misleading with respect to the period covered by this report; |
| 3. | Based on my knowledge, the financial statements, and other financial information included in this report, fairly present in all material respects the financial condition, results of operations and cash flows of the registrant as of, and for, the periods presented in this report; |
| 4. | The registrant’s other certifying officer(s) and I are responsible for establishing and maintaining disclosure controls and procedures (as defined in Exchange Act Rules 13a-15(e) and 15d-15(e)) and internal control over financial reporting (as defined in Exchange Act Rules 13a-15(f) and 15d-15(f)) for the registrant and have: |
| (a) | Designed such disclosure controls and procedures, or caused such disclosure controls and procedures to be designed under our supervision, to ensure that material information relating to the registrant, including its consolidated subsidiaries, is made known to us by others within those entities, particularly during the period in which this report is being prepared; |
| (b) | Designed such internal control over financial reporting, or caused such internal control over financial reporting to be designed under our supervision, to provide reasonable assurance regarding the reliability of financial reporting and the preparation of financial statements for external purposes in accordance with generally accepted accounting principles; |
| (c) | Evaluated the effectiveness of the registrant’s disclosure controls and procedures and presented in this report our conclusions about the effectiveness of the disclosure controls and procedures, as of the end of the period covered by this report based on such evaluation; and |
| (d) | Disclosed in this report any change in the registrant’s internal control over financial reporting that occurred during the registrant’s most recent fiscal quarter (the registrant’s fourth fiscal quarter in the case of an annual report) that has materially affected, or is reasonably likely to materially affect, the registrant’s internal control over financial reporting; and |
| 5. | The registrant’s other certifying officer(s) and I have disclosed, based on our most recent evaluation of internal control over financial reporting, to the registrant’s auditors and the audit committee of the registrant’s board of directors (or persons performing the equivalent functions): |
| (a) | All significant deficiencies and material weaknesses in the design or operation of internal control over financial reporting which are reasonably likely to adversely affect the registrant’s ability to record, process, summarize and report financial information; and |
| (b) | Any fraud, whether or not material, that involves management or other employees who have a significant role in the registrant’s internal control over financial reporting. |
| By: | /s/ Michael J. Catelani | |
| Michael J. Catelani | ||
| Chief Operating Officer and | ||
| Chief Financial Officer | ||
| September 8, 2020 | (Principal Financial and Accounting Officer) |
Exhibit 32.1
Statement of Chief Executive Officer
Pursuant to Section 1350 of Title 18 of the United States Code
Pursuant to Section 1350 of Title 18 of the United States Code, the undersigned, Dr. Amit Kumar, the Chairman, President and Chief Executive Officer of Anixa Biosciences, Inc., hereby certifies that:
| 1. | The Company’s Form 10-Q Quarterly Report for the period ended July 31, 2020 (the “Report”) fully complies with the requirements of Section 13(a) or 15(d) of the Securities Exchange Act of 1934; and |
| 2. | The information contained in the Report fairly presents, in all material respects, the financial condition and results of operations of the Company. |
| By: | /s/ Dr. Amit Kumar | |
| Dr. Amit Kumar | ||
| Chairman, President and | ||
| Chief Executive Officer | ||
| September 8, 2020 | (Principal Executive Officer) |
Exhibit 32.2
Statement of Chief Financial Officer
Pursuant to Section 1350 of Title 18 of the United States Code
Pursuant to Section 1350 of Title 18 of the United States Code, the undersigned, Michael J. Catelani, the Chief Operating Officer and Chief Financial Officer of Anixa Biosciences, Inc., hereby certifies that:
| 3. | The Company’s Form 10-Q Quarterly Report for the period ended July 31, 2020 (the “Report”) fully complies with the requirements of Section 13(a) or 15(d) of the Securities Exchange Act of 1934; and |
| 4. | The information contained in the Report fairly presents, in all material respects, the financial condition and results of operations of the Company. |
| By: | /s/ Michael J. Catelani | |
| Michael J. Catelani | ||
| Chief Operating Officer and | ||
| Chief Financial Officer | ||
| September 8, 2020 | (Principal Financial and Accounting Officer) |