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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, 2023
or
☐
TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934
For
the transition period from ______ to ______
Commission
file number 001-37492
ANIXA
BIOSCIENCES, INC.
(Exact
name of registrant as specified in its charter)
Delaware |
|
11-2622630 |
(State
or other jurisdiction of |
|
(I.R.S.
Employer |
incorporation
or organization) |
|
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.
Indicate
by check mark whether the registrant has submitted electronically every Interactive Data File required to be submitted pursuant to Rule
405 of Regulation S-T (§232.405 of this chapter) during the preceding 12 months (or for such shorter period that the registrant
was required to submit such files).
Indicate
by check mark whether the registrant is a large accelerated filer, an accelerated filer, a non-accelerated filer, smaller reporting company,
or an emerging growth company. See the definitions of “large accelerated filer,” “accelerated filer,” “smaller
reporting company,” and “emerging growth company” in Rule 12b-2 of the Exchange Act.
Large
accelerated filer ☐ |
|
Accelerated
filer ☐ |
Non-accelerated
filer ☒ |
Smaller
reporting company ☒ |
Emerging
growth company ☐ |
If
an emerging growth company, indicate by check mark if the registrant has elected not to use the extended transition period for complying
with any new or revised financial accounting standards provided pursuant to Section 13(a) of the Exchange Act. ☐
Indicate
by check mark whether the registrant is a shell company (as defined in Rule 12b-2 of the Exchange Act).
Indicate
the number of shares outstanding of each of the issuer’s classes of common stock, as of the latest practicable date.
On
September 6, 2023 the registrant had outstanding 31,070,022 shares of Common Stock, par value $.01 per share, which is the registrant’s
only class of common stock.
TABLE
OF CONTENTS
PART
I. FINANCIAL INFORMATION
Item
1. Financial Statements.
ANIXA
BIOSCIENCES, INC. AND SUBSIDIARIES
CONDENSED
CONSOLIDATED BALANCE SHEETS (UNAUDITED)
(in
thousands, except share and per share data)
| |
July 31, 2023 | | |
October 31, 2022 | |
| |
| | |
| |
ASSETS | |
| | |
| |
Current assets: | |
| | | |
| | |
Cash and cash equivalents | |
$ | 3,198 | | |
$ | 12,360 | |
Short-term investments | |
| 22,336 | | |
| 17,327 | |
Receivables | |
| 334 | | |
| 47 | |
Prepaid expenses and other current assets | |
| 532 | | |
| 466 | |
Total current assets | |
| 26,400 | | |
| 30,200 | |
| |
| | | |
| | |
Operating lease right-of-use asset | |
| 178 | | |
| 212 | |
Total assets | |
$ | 26,578 | | |
$ | 30,412 | |
| |
| | | |
| | |
LIABILITIES AND EQUITY | |
| | | |
| | |
Current liabilities: | |
| | | |
| | |
Accounts payable | |
$ | 94 | | |
$ | 265 | |
Accrued expenses | |
| 1,712 | | |
| 1,726 | |
Operating lease liability | |
| 51 | | |
| 46 | |
Total current liabilities | |
| 1,857 | | |
| 2,037 | |
| |
| | | |
| | |
Operating lease liability, non-current | |
| 136 | | |
| 175 | |
Total liabilities | |
| 1,993 | | |
| 2,212 | |
| |
| | | |
| | |
Commitments and contingencies (Note 10) | |
| - | | |
| - | |
| |
| | | |
| | |
Equity: | |
| | | |
| | |
Shareholders’ equity: | |
| | | |
| | |
Preferred stock, par value $100 per share; 19,860 shares authorized; no shares issued or outstanding | |
| - | | |
| - | |
Series A convertible preferred stock, par value $100 per share; 140 shares
authorized; no shares issued or outstanding | |
| - | | |
| - | |
Preferred stock, value | |
| - | | |
| - | |
Common stock, par value $.01 per share; 100,000,000 shares authorized; 31,017,770 and 30,913,902
shares issued and outstanding as of July 31, 2023 and October 31, 2022, respectively | |
| 310 | | |
| 309 | |
Additional paid-in capital | |
| 250,716 | | |
| 247,123 | |
Accumulated deficit | |
| (225,506 | ) | |
| (218,385 | ) |
Total shareholders’ equity | |
| 25,520 | | |
| 29,047 | |
Noncontrolling interest (Note 2) | |
| (935 | ) | |
| (847 | ) |
Total equity | |
| 24,585 | | |
| 28,200 | |
| |
| | | |
| | |
Total liabilities and equity | |
$ | 26,578 | | |
$ | 30,412 | |
The
accompanying notes are an integral part of these condensed consolidated financial statements.
ANIXA
BIOSCIENCES, INC. AND SUBSIDIARIES
CONDENSED
CONSOLIDATED STATEMENTS OF OPERATIONS (UNAUDITED)
(in
thousands, except per share data)
| |
2023 | | |
2022 | | |
2023 | | |
2022 | |
| |
For the three months ended | | |
For the nine months ended | |
| |
July 31, | | |
July 31, | |
| |
2023 | | |
2022 | | |
2023 | | |
2022 | |
| |
| | |
| | |
| | |
| |
Revenue | |
$ | - | | |
$ | - | | |
$ | 210 | | |
$ | - | |
| |
| | | |
| | | |
| | | |
| | |
Operating costs and expenses: | |
| | | |
| | | |
| | | |
| | |
Inventor royalties, contingent legal fees, litigation and licensing expenses | |
| - | | |
| - | | |
| 161 | | |
| - | |
Research and development expenses (including non-cash share-based compensation expenses of $520, $771, $1,517 and $3,014, respectively) | |
| 1,088 | | |
| 1,445 | | |
| 3,154 | | |
| 5,018 | |
General and administrative expenses (including non-cash share-based compensation expenses of $697, $675, $1,990 and $2,531, respectively) | |
| 1,756 | | |
| 1,352 | | |
| 4,855 | | |
| 5,248 | |
Total operating costs and expenses | |
| 2,844 | | |
| 2,797 | | |
| 8,170 | | |
| 10,266 | |
| |
| | | |
| | | |
| | | |
| | |
Loss from operations | |
| (2,844 | ) | |
| (2,797 | ) | |
| (7,960 | ) | |
| (10,266 | ) |
| |
| | | |
| | | |
| | | |
| | |
Interest income | |
| 296 | | |
| 22 | | |
| 751 | | |
| 24 | |
| |
| | | |
| | | |
| | | |
| | |
Net loss | |
| (2,548 | ) | |
| (2,775 | ) | |
| (7,209 | ) | |
| (10,242 | ) |
| |
| | | |
| | | |
| | | |
| | |
Less: Net loss attributable to noncontrolling interest | |
| (37 | ) | |
| (29 | ) | |
| (88 | ) | |
| (123 | ) |
| |
| | | |
| | | |
| | | |
| | |
Net loss attributable to common shareholders | |
$ | (2,511 | ) | |
$ | (2,746 | ) | |
$ | (7,121 | ) | |
$ | (10,119 | ) |
| |
| | | |
| | | |
| | | |
| | |
Net loss per common share attributable to common shareholders: | |
| | | |
| | | |
| | | |
| | |
Basic and diluted | |
$ | (0.08 | ) | |
$ | (0.09 | ) | |
$ | (0.23 | ) | |
$ | (0.33 | ) |
Basic | |
$ | (0.08 | ) | |
$ | (0.09 | ) | |
$ | (0.23 | ) | |
$ | (0.33 | ) |
| |
| | | |
| | | |
| | | |
| | |
Weighted average common shares outstanding: | |
| | | |
| | | |
| | | |
| | |
Basic and diluted | |
| 30,974 | | |
| 30,451 | | |
| 30,941 | | |
| 30,244 | |
Basic | |
| 30,974 | | |
| 30,451 | | |
| 30,941 | | |
| 30,244 | |
The
accompanying notes are an integral part of these condensed consolidated financial statements.
ANIXA
BIOSCIENCES, INC. AND SUBSIDIARIES
CONDENSED
CONSOLIDATED STATEMENTS OF EQUITY (UNAUDITED)
(in
thousands, except share data)
FOR
THE THREE MONTHS ENDED JULY 31, 2023
| |
| | | |
| | | |
| | | |
| | | |
| | | |
| | | |
| | |
| |
| | |
| | |
Additional | | |
| | |
Total | | |
Non- | | |
| |
| |
Common Stock | | |
Paid-in | | |
Accumulated | | |
Shareholders’ | | |
controlling | | |
Total | |
| |
Shares | | |
Par Value | | |
Capital | | |
Deficit | | |
Equity | | |
Interest | | |
Equity | |
| |
| | |
| | |
| | |
| | |
| | |
| | |
| |
Balance, April 30, 2023 | |
| 30,958,665 | | |
$ | 310 | | |
$ | 249,496 | | |
$ | (222,995 | ) | |
$ | 26,811 | | |
$ | (898 | ) | |
$ | 25,913 | |
Stock option compensation to employees and directors | |
| - | | |
| - | | |
| 1,153 | | |
| - | | |
| 1,153 | | |
| - | | |
| 1,153 | |
Stock options issued to consultants | |
| - | | |
| - | | |
| 47 | | |
| - | | |
| 47 | | |
| - | | |
| 47 | |
Common stock issued upon exercise of stock options | |
| 55,029 | | |
| - | | |
| 3 | | |
| - | | |
| 3 | | |
| - | | |
| 3 | |
Common stock issued to consultants | |
| 4,076 | | |
| - | | |
| 17 | | |
| - | | |
| 17 | | |
| - | | |
| 17 | |
Net loss | |
| - | | |
| - | | |
| - | | |
| (2,511 | ) | |
| (2,511 | ) | |
| (37 | ) | |
| (2,548 | ) |
Balance, July 31, 2023 | |
| 31,017,770 | | |
$ | 310 | | |
$ | 250,716 | | |
$ | (225,506 | ) | |
$ | 25,520 | | |
$ | (935 | ) | |
$ | 24,585 | |
FOR
THE THREE MONTHS ENDED JULY 31, 2022
| |
| | |
| | |
Additional | | |
| | |
Total | | |
Non- | | |
| |
| |
Common Stock | | |
Paid-in | | |
Accumulated | | |
Shareholders’ | | |
controlling | | |
Total | |
| |
Shares | | |
Par Value | | |
Capital | | |
Deficit | | |
Equity | | |
Interest | | |
Equity | |
| |
| | |
| | |
| | |
| | |
| | |
| | |
| |
Balance, April 30, 2022 | |
| 30,154,708 | | |
$ | 302 | | |
$ | 244,032 | | |
$ | (212,163 | ) | |
$ | 32,171 | | |
$ | (765 | ) | |
$ | 31,406 | |
Stock option compensation to employees and directors | |
| - | | |
| - | | |
| 1,329 | | |
| - | | |
| 1,329 | | |
| - | | |
| 1,329 | |
Stock options issued to consultants | |
| - | | |
| - | | |
| 109 | | |
| - | | |
| 109 | | |
| - | | |
| 109 | |
Common stock issued upon exercise of stock options | |
| 496,048 | | |
| 5 | | |
| 825 | | |
| - | | |
| 830 | | |
| - | | |
| 830 | |
Common stock issued to consultants | |
| 2,662 | | |
| - | | |
| 8 | | |
| - | | |
| 8 | | |
| - | | |
| 8 | |
Net loss | |
| - | | |
| - | | |
| - | | |
| (2,746 | ) | |
| (2,746 | ) | |
| (29 | ) | |
| (2,775 | ) |
Balance, July 31, 2022 | |
| 30,653,418 | | |
$ | 307 | | |
$ | 246,303 | | |
$ | (214,909 | ) | |
$ | 31,701 | | |
$ | (794 | ) | |
$ | 30,907 | |
The
accompanying notes are an integral part of these condensed consolidated financial statements.
ANIXA
BIOSCIENCES, INC. AND SUBSIDIARIES
CONDENSED
CONSOLIDATED STATEMENTS OF EQUITY (UNAUDITED)
(in
thousands, except share data)
FOR
THE NINE MONTHS ENDED JULY 31, 2023
| |
| | |
| | |
Additional | | |
| | |
Total | | |
Non- | | |
| |
| |
Common Stock | | |
Paid-in | | |
Accumulated | | |
Shareholders’ | | |
controlling | | |
Total | |
| |
Shares | | |
Par Value | | |
Capital | | |
Deficit | | |
Equity | | |
Interest | | |
Equity | |
| |
| | |
| | |
| | |
| | |
| | |
| | |
| |
Balance, October 31, 2022 | |
| 30,913,902 | | |
$ | 309 | | |
$ | 247,123 | | |
$ | (218,385 | ) | |
$ | 29,047 | | |
$ | (847 | ) | |
$ | 28,200 | |
Stock option compensation to employees and directors | |
| - | | |
| - | | |
| 3,265 | | |
| - | | |
| 3,265 | | |
| - | | |
| 3,265 | |
Stock options and warrants issued to consultants | |
| - | | |
| - | | |
| 175 | | |
| - | | |
| 175 | | |
| - | | |
| 175 | |
Common stock issued upon exercise of stock options | |
| 84,411 | | |
| 1 | | |
| 80 | | |
| - | | |
| 81 | | |
| - | | |
| 81 | |
Common stock issued to consultants | |
| 17,554 | | |
| - | | |
| 67 | | |
| - | | |
| 67 | | |
| - | | |
| 67 | |
Common stock issued pursuant to employee stock purchase plan | |
| 1,903 | | |
| - | | |
| 6 | | |
| - | | |
| 6 | | |
| - | | |
| 6 | |
Net loss | |
| - | | |
| - | | |
| - | | |
| (7,121 | ) | |
| (7,121 | ) | |
| (88 | ) | |
| (7,209 | ) |
Balance, July 31, 2023 | |
| 31,017,770 | | |
$ | 310 | | |
$ | 250,716 | | |
$ | (225,506 | ) | |
$ | 25,520 | | |
$ | (935 | ) | |
$ | 24,585 | |
FOR
THE NINE MONTHS ENDED JULY 31, 2022
| |
| | |
| | |
Additional | | |
| | |
Total | | |
Non- | | |
| |
| |
Common Stock | | |
Paid-in | | |
Accumulated | | |
Shareholders’ | | |
controlling | | |
Total | |
| |
Shares | | |
Par Value | | |
Capital | | |
Deficit | | |
Equity | | |
Interest | | |
Equity | |
| |
| | |
| | |
| | |
| | |
| | |
| | |
| |
Balance, October 31, 2021 | |
| 30,050,894 | | |
$ | 301 | | |
$ | 239,927 | | |
$ | (204,790 | ) | |
$ | 35,438 | | |
$ | (671 | ) | |
$ | 34,767 | |
Balance | |
| 30,050,894 | | |
$ | 301 | | |
$ | 239,927 | | |
$ | (204,790 | ) | |
$ | 35,438 | | |
$ | (671 | ) | |
$ | 34,767 | |
Stock option compensation to employees and directors | |
| - | | |
| - | | |
| 4,928 | | |
| - | | |
| 4,928 | | |
| - | | |
| 4,928 | |
Stock options and warrants issued to consultants | |
| - | | |
| - | | |
| 546 | | |
| - | | |
| 546 | | |
| - | | |
| 546 | |
Common stock issued upon exercise of stock options and warrants | |
| 577,473 | | |
| 6 | | |
| 824 | | |
| - | | |
| 830 | | |
| - | | |
| 830 | |
Common stock issued to consultants | |
| 22,662 | | |
| - | | |
| 72 | | |
| - | | |
| 72 | | |
| - | | |
| 72 | |
Common stock issued pursuant to employee stock purchase plan | |
| 2,389 | | |
| - | | |
| 6 | | |
| - | | |
| 6 | | |
| - | | |
| 6 | |
Net loss | |
| - | | |
| - | | |
| - | | |
| (10,119 | ) | |
| (10,119 | ) | |
| (123 | ) | |
| (10,242 | ) |
Balance, July 31, 2022 | |
| 30,653,418 | | |
$ | 307 | | |
$ | 246,303 | | |
$ | (214,909 | ) | |
$ | 31,701 | | |
$ | (794 | ) | |
$ | 30,907 | |
Balance | |
| 30,653,418 | | |
$ | 307 | | |
$ | 246,303 | | |
$ | (214,909 | ) | |
$ | 31,701 | | |
$ | (794 | ) | |
$ | 30,907 | |
The
accompanying notes are an integral part of these condensed consolidated financial statements.
ANIXA
BIOSCIENCES, INC. AND SUBSIDIARIES
CONDENSED
CONSOLIDATED STATEMENTS OF CASH FLOWS (UNAUDITED)
(in
thousands)
| |
2023 | | |
2022 | |
| |
For the nine months ended July 31, | |
| |
2023 | | |
2022 | |
Cash flows from operating activities: | |
| | | |
| | |
Reconciliation of net loss to net cash used in operating activities: | |
| | | |
| | |
Net loss | |
$ | (7,209 | ) | |
$ | (10,242 | ) |
Stock option compensation to employees and directors | |
| 3,265 | | |
| 4,928 | |
Stock options and warrants issued to consultants | |
| 175 | | |
| 546 | |
Common stock issued to consultants | |
| 67 | | |
| 72 | |
Amortization of operating lease right-of-use asset | |
| 34 | | |
| 31 | |
Change in operating assets and liabilities: | |
| | | |
| | |
Receivables | |
| (288 | ) | |
| - | |
Prepaid expenses and other current assets | |
| (65 | ) | |
| (400 | ) |
Accounts payable | |
| (171 | ) | |
| 91 | |
Accrued expenses | |
| (14 | ) | |
| 103 | |
Operating lease liability | |
| (34 | ) | |
| (28 | ) |
Net cash used in operating activities | |
| (4,240 | ) | |
| (4,899 | ) |
| |
| | | |
| | |
Cash flows from investing activities: | |
| | | |
| | |
Disbursements to acquire short-term investments | |
| (27,502 | ) | |
| (11,159 | ) |
Proceeds from maturities of short-term investments | |
| 22,493 | | |
| 10,348 | |
Net cash used in investing activities | |
| (5,009 | ) | |
| (811 | ) |
| |
| | | |
| | |
Cash flows from financing activities: | |
| | | |
| | |
Proceeds from sale of common stock pursuant to employee stock purchase plan | |
| 6 | | |
| 6 | |
Proceeds from exercise of stock options | |
| 81 | | |
| 830 | |
Net cash provided by financing activities | |
| 87 | | |
| 836 | |
| |
| | | |
| | |
Net decrease in cash and cash equivalents | |
| (9,162 | ) | |
| (4,874 | ) |
Cash and cash equivalents at beginning of period | |
| 12,360 | | |
| 29,128 | |
Cash and cash equivalents at end of period | |
$ | 3,198 | | |
$ | 24,254 | |
The
accompanying notes are an integral part of these condensed consolidated financial statements.
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 vaccine programs include (i) the development of a preventative vaccine against triple
negative breast cancer (“TNBC”), the most lethal form of breast cancer, as well other forms of breast cancer and (ii) the
development of a preventative vaccine against ovarian cancer. Our therapeutics programs include (i) the development of a chimeric endocrine
receptor T-cell therapy, a novel form of chimeric antigen receptor T-cell (“CAR-T”) technology, initially focused on treating
ovarian cancer, which is being developed at our subsidiary, Certainty Therapeutics, Inc. (“Certainty”), and (ii) until March
2023, the development of anti-viral drug candidates for the treatment of COVID-19 focused on inhibiting certain protein functions of
the virus.
We
hold an exclusive worldwide, royalty-bearing license to use certain intellectual property owned or controlled by The Cleveland Clinic
Foundation (“Cleveland Clinic”) relating to certain breast cancer vaccine technology developed at Cleveland Clinic. Utilizing
this technology, we are working in collaboration with Cleveland Clinic to develop a method to vaccinate women against contracting breast
cancer, focused specifically on TNBC. The focus of this vaccine is a specific protein, α-lactalbumin, that is only expressed during
lactation in a healthy mother’s mammary tissue. This protein disappears when the mother is no longer lactating, but reappears in
many forms of breast cancer, especially TNBC. Studies have shown that vaccinating against this protein prevents breast cancer in mice.
Following
the U.S. Food and Drug Administration’s (“FDA”) authorization to proceed with clinical trials in December 2020, in
October 2021, we commenced dosing patients in a Phase 1 clinical trial of our breast cancer vaccine. This study, which is being funded
by a U.S. Department of Defense grant, is a multiple-ascending dose Phase 1 trial to determine the maximum tolerated dose (“MTD”)
of the vaccine in patients with early-stage, triple-negative breast cancer as well as monitor immune response. The study is being conducted
at Cleveland Clinic. The first segment of the study, Phase 1a, will consist of 18 to 24 patients who have completed treatment for early-stage,
triple-negative breast cancer within the past three years and are currently tumor-free but at high risk for recurrence. Studies show
that 42% of TNBC patients will have a recurrence of their cancer, with most of the recurrences occurring in the first two to three years
after standard of care treatment. During the course of the Phase 1a study, participants will receive three vaccinations, each two weeks
apart, and will be closely monitored for side effects and immune response. In April 2023, we presented the immunological data collected
to date at the annual meeting of the American Association for Cancer Research. The data presented show that in the vaccinated women who
had been tested to date, various levels of antigen-specific T cell responses were observed at all dose levels. In January 2023, the number
of participants in each dose cohort was expanded, and as of August 2023, we have completed vaccinating all patients in these expanded
cohorts. The patient blood samples are currently being analyzed, and we anticipate presenting data from all Phase 1a trial participants
vaccinated to date at the San Antonio Breast Cancer Symposium in December 2023. In the coming months, we will begin vaccinating participants
in two additional dose cohorts at dose levels higher than the currently determined maximum tolerated dose and lower than the highest
dose where we saw dose limiting toxicity. Further, we have commenced recruitment for participants in the second segment of the trial,
Phase 1b, that will include participants who have never had cancer, but carry certain genetic mutations that indicate a greater risk
of developing TNBC in the future. Finally, we have also commenced recruitment for participants in the third segment of the trial, Phase
1c, that will include participants who are currently undergoing treatment with pembrolizumab (Keytruda®).
In
November 2020, we executed a license agreement with Cleveland Clinic pursuant to which the Company was granted an exclusive worldwide,
royalty-bearing license to use certain intellectual property owned or controlled by Cleveland Clinic relating to certain ovarian cancer
vaccine technology. This technology pertains to among other things, the use of vaccines for the treatment or prevention of ovarian cancers
which express the anti-Mullerian hormone receptor 2 protein containing an extracellular domain (“AMHR2-ED”). In healthy tissue,
this protein regulates growth and development of egg-containing follicles in the ovary. While expression of AMHR2-ED naturally and markedly
declines during menopause, this protein is expressed at high levels in the ovaries of postmenopausal women with ovarian cancer. Researchers
at Cleveland Clinic believe that a vaccine targeting AMHR2-ED could prevent the occurrence of ovarian cancer. We entered into a joint
development agreement with Cleveland Clinic to advance this vaccine toward human clinical testing.
In
May 2021, Cleveland Clinic was granted an award for our ovarian cancer vaccine technology by the National Cancer Institute’s (“NCI”)
PREVENT program. The NCI is a part of the National Institutes of Health (“NIH”). The PREVENT program is a peer-reviewed agent
development program designed to support pre-clinical development of innovative interventions and biomarkers for cancer prevention and
interception towards clinical trials. The scientific and financial resources of the PREVENT program are being used for our ovarian cancer
vaccine technology to perform virtually all pre-clinical research and development, manufacturing and IND-enabling studies. This work
is being performed at NCI facilities, by NCI scientific staff and with NCI financial resources and will require no material financial
expenditures by the Company, nor the transfer of any rights of the Company’s assets.
Our
subsidiary, 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”), the nation’s first independent
biomedical research institute and a leading NCI designated cancer research center, relating to Wistar’s chimeric endocrine receptor
targeted therapy technology. We have initially focused on the development of a treatment for ovarian cancer, but we also may pursue applications
of the technology for the development of treatments for additional solid tumors. The license agreement requires Certainty to make certain
cash and equity payments to Wistar upon achievement of specific development milestones. With respect to Certainty’s equity obligations
to Wistar, Certainty issued to Wistar shares of its common stock equal to five percent (5%) of the common stock of Certainty.
Certainty,
in collaboration with the H. Lee Moffitt Cancer Center and Research Institute, Inc. (“Moffitt”), has begun human clinical
testing of the CAR-T technology licensed by Certainty from Wistar aimed initially at treating ovarian cancer. We received authorization
from the FDA in August 2021, to commence enrollment and treatment of patients in a Phase 1 clinical trial. We began patient recruitment
for the trial in March 2022, and in August 2022, we treated the first patient in the trial, and the treatment was well-tolerated by the
patient. Further, in May 2023 and August 2023, we treated the second and third patients in the trial, respectively, at the same dose
level as the first patient, and the treatment appears to have been well-tolerated by both patients. We anticipate that we will begin
enrolling the successive patient cohort, that we expect to give a three-times higher dose of cells, in the fourth quarter of 2023. This
study is a dose-escalation trial with two arms based on delivery method—intraperitoneal or intravenous—to determine the maximum
tolerated dose in patients with recurrent epithelial ovarian cancer and to assess persistence, expansion and efficacy of the modified
T-cells. The study is being conducted at Moffitt and will consist of 24 to 48 patients who have received at least two prior lines of
chemotherapy. The study is estimated to be completed in two to four years depending on multiple factors including when maximum tolerated
dose is reached, the rate of patient enrollment, and how long we maintain the two different delivery methods.
In
April 2020, we entered into a collaboration with OntoChem GmbH (“OntoChem”) which was later assigned to MolGenie GmbH (“MolGenie”),
a company spun-out from OntoChem focused on drug discovery and development, to discover and ultimately develop anti-viral drug candidates
against COVID-19. Through this collaboration, we identified compounds that appeared to be effective in disrupting the main protease of
SARS-CoV-2, the virus that causes the disease COVID-19. While our compounds have shown promise as an effective treatment, results of
animal studies indicate that there is not sufficient oral bioavailability, and it is unclear whether an orally delivered treatment may
be developed. We do not currently believe that there is a viable market for an injectable treatment given the current oral treatments
available. Furthermore, we believe the needed additional investment in research for alternative delivery methods would divert resources
from more promising projects. Therefore, on March 9, 2023, we decided to pause further development of our COVID-19 therapeutic. We continue
to prosecute our U.S. patent applications of this technology and may decide to restart development at some time in the future.
Over
the next several quarters, we expect the development of our vaccines and therapeutics to be the primary focus of the Company. As part
of our legacy operations, the Company remains engaged in limited patent licensing activities of its various patent portfolios. 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 (during the nine months ended July 31, 2023, we derived approximately $210,000 of revenue from these activities).
We have not generated any revenue to date from our vaccine or therapeutics programs. In addition, while we pursue our vaccine and therapeutics
programs, we may also make investments in and form new companies to develop additional emerging technologies. We do not expect to begin
generating revenue with respect to any of our current vaccine or therapy programs in the near term. We hope to achieve a profitable outcome
by eventually licensing our technologies to large pharmaceutical companies that have the resources and infrastructure in place to manufacture,
market and sell our technologies as vaccines or therapeutics. The eventual licensing of any of our technologies may take several years,
if it is to occur at all, and may depend on positive results from human clinical trials.
Funding
and Management’s Plans
Based
on currently available information as of September 6, 2023, we believe that our existing cash, cash equivalents, short-term investments
and expected cash flows will be sufficient to fund our activities for at least the next twelve months. We have implemented a business
model that conserves funds by collaborating with third parties to develop our technologies. However, our projections of future cash needs
and cash flows may differ from actual results. If current cash on hand, cash equivalents, short-term investments and cash that may be
generated from our business operations are insufficient to continue to operate our business, or if we elect to invest in or acquire a
company or companies or new technology or technologies that are synergistic with or complementary to our technologies, we may be required
to obtain more working capital. Under our at-the-market equity program as of July 31, 2023, we may sell up to $100 million of common
stock. We did not sell any shares under our at-the-market equity program during the three and nine months ended July 31, 2023. We may
seek to obtain working capital during our fiscal year 2023 or thereafter through sales of our equity securities or public or private
debt from various financial institutions where possible. We cannot be certain that additional funding will be available on acceptable
terms, or at all. If we do identify sources for additional funding, the sale of additional equity securities or convertible debt will
result in dilution to our stockholders. We can give no assurance that we will generate sufficient cash flows in the future to satisfy
our liquidity requirements or sustain future operations, or that other sources of funding, such as sales of equity or debt, would be
available or would be approved by our security holders, if needed, on favorable terms or at all. If we fail to obtain additional working
capital as and when needed, such failure could have a material adverse impact on our business, results of operations and financial condition.
Furthermore, such lack of funds may inhibit our ability to respond to competitive pressures or unanticipated capital needs, or may force
us to reduce operating expenses, which would significantly harm the business and development of operations.
2.
SIGNIFICANT ACCOUNTING POLICIES
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 fiscal year ended October 31, 2022. The accompanying October 31, 2022 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, 2023, and results of operations and cash flows for the interim periods represented. The results of operations
for the three and nine months ended July 31, 2023 are not necessarily indicative of the results to be expected for the year.
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, 2023 (in thousands):
SCHEDULE OF CHANGES IN NONCONTROLLING INTEREST
Balance, October 31, 2022 | |
$ | (847 | ) |
Net loss attributable to noncontrolling interest | |
| (88 | ) |
Balance, July 31, 2023 | |
$ | (935 | ) |
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.
Our
revenue recognition policy requires us 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, within 30 days of execution of the agreement, of contractually determined, one-time, paid-up
license fees in settlement of litigation and in consideration for the grant of certain intellectual property rights for patented technologies
owned or controlled by the Company. These arrangements typically include some combination of the following: (i) the grant of a non-exclusive,
retroactive and future license to manufacture and/or sell products covered by patented technologies owned or controlled by the Company,
(ii) a covenant-not-to-sue, (iii) the release of the licensee from certain claims, and (iv) the dismissal of any pending litigation.
In such instances, the intellectual property rights granted have been perpetual in nature, extending until the expiration of the related
patents. Pursuant to the terms of these agreements, we have no further obligations with respect to the granted intellectual property
rights, including no obligation to maintain or upgrade the technology, or provide future support or services. Licensees obtained control
of the intellectual property rights they have acquired upon execution of the agreement. Accordingly, the performance obligations from
these agreements were satisfied and 100% of the revenue was recognized upon the execution of the agreements.
Cost
of Revenues
Cost
of revenues include the costs and expenses incurred in connection with our patent licensing and enforcement activities, including inventor
royalties paid to original patent owners, contingent legal fees paid to external counsel, other patent-related legal expenses paid to
external counsel and licensing and enforcement related research, consulting and other expenses paid to third-parties. These costs are
included under the caption “Operating costs and expenses” in the accompanying condensed consolidated statements of operations.
Research
and Development Expenses
Research
and development expenses, consisting primarily of employee compensation, payments to third parties for research and development activities
and other direct costs associated with developing immuno-therapy drugs against cancer, developing anti-viral drug candidates for COVID-19
(through March 2023), developing our breast cancer vaccine, and developing our ovarian cancer vaccine, are expensed in the consolidated
financial statements in the period incurred.
Investment
Policy
The
Company’s investment policy is to acquire debt securities with fixed maturities and contractual cash flows that the Company has
the positive intent and ability to hold to maturity. These securities are recorded at amortized cost, net of any applicable discount
which is amortized to interest income, and are accounted for as held-to-maturity securities.
3.
SHARE-BASED COMPENSATION
The
Company maintains 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 share-based compensation expense related to service-based
stock options granted to employees and directors of approximately $1,153,000 and $941,000 during the three months ended July 31, 2023
and 2022, respectively, and approximately $3,265,000 and $2,546,000 during the nine months ended July 31, 2023 and 2022, 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 June 1, 2021, our Chairman and Chief Executive Officer and
our President, Chief Operating Officer and Chief Financial Officer were awarded market condition stock options for 2,000,000 shares and
100,000 shares of common stock, respectively, that vest in four equal installments upon the Company’s share price achieving targets
ranging from $5.00 to $8.00 per share, with implied service periods of three to fifteen months. We recorded market condition stock-based
compensation expense during the three months ended July 31, 2023 and 2022 of approximately $0 and $388,000, respectively, and approximately
$0 and $2,381,000 during the nine months ended July 31, 2023 and 2022, respectively.
The
compensation cost for service-based stock options granted to consultants is measured at the grant date, based on the fair value of the
award using the Black-Scholes pricing model, and is expensed on a straight-line basis over the requisite service period (the vesting
period of the stock option) which is one to three years. We recorded stock-based consulting expense related to stock options granted
to consultants of approximately $47,000 and $109,000 during the three months ended July 31, 2023 and 2022, respectively, and approximately
$175,000 and $326,000 during the nine months ended July 31, 2023 and 2022, respectively.
For
stock options granted to consultants that vest based on market conditions, such as changes in trading activity in the Company’s
common stock, we use the Black-Scholes pricing model to estimate the fair value at the time which we believe the market conditions are
reasonably likely to be met. On January 30, 2023, we granted market condition stock options to a consultant for 200,000 shares of common
stock, that vests in full upon the achievement of certain Company stock trading activity metrics that must be met within twelve months.
We did not record any market condition stock-based compensation expense on the date of grant nor in the three and nine months ended July
31, 2023, as we do not believe it is likely that the market conditions will be met.
Stock
Option Plans
During
the three months ended July 31, 2023, we had securities outstanding that were granted from two stock option plans: the Anixa Biosciences,
Inc. 2010 Share Incentive Plan (the “2010 Share Plan”) and the Anixa Biosciences, Inc. 2018 Share Incentive Plan (the “2018
Share Plan”), which were adopted by our Board of Directors on July 14, 2010 and January 25, 2018, respectively. The 2018 Share
Plan was approved by our shareholders on March 29, 2018.
Stock
Option Activity
During
the three months ended July 31, 2023 and 2022, we did not grant any options to purchase shares of common stock, and during the nine months
ended July 31, 2023 and 2022, we granted options to purchase 1,505,000 shares and 1,430,000 shares of common stock, respectively, to
employees and consultants, with exercise prices ranging from $4.19 to $4.81 per share, pursuant to the 2018 Share Plan. During the three
months ended July 31, 2023 and 2022, stock options to purchase 10,446 and 321,388 shares of common stock, respectively, were exercised
on a cash basis, with aggregate proceeds of approximately $3,000 and $830,000, respectively. During the three months ended July 31, 2023
and 2022, stock options to purchase 160,000 shares of common stock, of which 115,417 shares were withheld, and 680,000 shares of common
stock, of which 505,340 shares were withheld, were exercised on a cashless basis, respectively. During the nine months ended July 31,
2023 and 2022, stock options to purchase 39,525 and 321,388 shares of common stock, respectively, were exercised on a cash basis, with
aggregate proceeds of approximately $81,000 and $830,000, respectively. During the nine months ended July 31, 2023 and 2022, stock options
to purchase 161,111 shares of common stock, of which 116,225 shares were withheld, and 780,000 shares of common stock, of which 558,431
shares were withheld, were exercised on a cashless basis, respectively.
2010
Share Plan
The
2010 Share Plan provided for the grant of nonqualified stock options, stock appreciation rights, stock awards, performance awards and
stock units to employees, directors and consultants. In accordance with the provisions of the 2010 Share Plan, the plan terminated with
respect to the ability to grant future awards on July 14, 2020. Information regarding the 2010 Share Plan for the nine months ended July
31, 2023 is as follows:
SCHEDULE OF OPTION ACTIVITY
| |
Shares | | |
Weighted
Average Exercise Price Per Share | | |
Aggregate
Intrinsic Value
(in thousands) | |
Options outstanding at October 31, 2022 | |
| 1,501,500 | | |
$ | 2.83 | | |
| | |
Exercised | |
| (194,264 | ) | |
$ | 2.46 | | |
| | |
Options outstanding and exercisable at July 31, 2023 | |
| 1,307,236 | | |
$ | 2.89 | | |
$ | 1,252 | |
The
following table summarizes information about stock options outstanding and exercisable under the 2010 Share Plan as of July 31, 2023:
SCHEDULE OF OUTSTANDING AND EXERCISABLE
Range of Exercise Prices | |
Number Outstanding and Exercisable | | |
Weighted Average Remaining Contractual Life (in years) | | |
Weighted Average Exercise Price | |
$0.67 - $2.27 | |
| 462,500 | | |
| 3.1 | | |
$ | 1.48 | |
$2.58 - $3.13 | |
| 335,736 | | |
| 2.3 | | |
$ | 2.89 | |
$3.46 - $5.30 | |
| 509,000 | | |
| 4.8 | | |
$ | 4.17 | |
2018
Share Plan
The
2018 Share Plan provides for the grant of incentive stock options, nonqualified stock options, stock appreciation rights, stock awards,
performance awards and stock units to employees, directors and consultants. As of July 31, 2023, the 2018 Share Plan had 825,000 shares
available for future grants. Information regarding the 2018 Share Plan for the nine months ended July 31, 2023 is as follows:
SCHEDULE OF OPTION ACTIVITY
| |
Shares | | |
Weighted Average Exercise Price Per Share | | |
Aggregate Intrinsic Value (in thousands) | |
Options outstanding at October 31, 2022 | |
| 8,817,372 | | |
$ | 3.57 | | |
| | |
Granted | |
| 1,505,000 | | |
$ | 4.29 | | |
| | |
Exercised | |
| (6,372 | ) | |
$ | 2.89 | | |
| | |
Expirations | |
| (150,000 | ) | |
$ | 5.30 | | |
| | |
Options outstanding at July 31, 2023 | |
| 10,166,000 | | |
$ | 3.68 | | |
$ | 2,308 | |
Options exercisable at July 31, 2023 | |
| 6,366,137 | | |
$ | 3.51 | | |
$ | 1,699 | |
The
following table summarizes information about stock options outstanding and exercisable under the 2018 Share Plan as of July 31, 2023:
SCHEDULE OF OUTSTANDING AND EXERCISABLE
| |
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 | |
$ 2.09 - $3.87 | |
| 5,341,000 | | |
| 6.7 | | |
$ | 3.24 | | |
| 4,618,778 | | |
| 6.4 | | |
$ | 3.31 | |
$ 3.96 - $5.30 | |
| 4,825,000 | | |
| 7.9 | | |
$ | 4.16 | | |
| 1,747,359 | | |
| 7.1 | | |
$ | 4.03 | |
Employee
Stock Purchase Plan
The
Company maintains the Anixa Biosciences, Inc. Employee Stock Purchase Plan (the “ESPP”) 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, 2023 and 2022, employees purchased 1,903 and 2,389 shares,
respectively, with aggregate proceeds of approximately $6,000 and $6,000, respectively.
Warrants
On
October 30, 2020, we issued a warrant, expiring on October 30, 2025, to purchase 60,000 shares of common stock at $2.06 per share, vesting
over five months, to a consultant for investor relations services. On November 16, 2021, the warrant was exercised on a cashless basis
and 25,484 shares were withheld as payment.
On
November 1, 2021, we issued a warrant, expiring on October 30, 2026, to purchase 60,000 shares of common stock at $4.77 per share, vesting
over five months, to a consultant for investor relations services. We recorded consulting expense of approximately $0 and $220,000, respectively,
during the three and nine months ended July 31, 2022, based on the fair value of the warrant on the date of grant recognized on a straight-line
basis over the vesting period. The warrant terminated in May 2022 upon termination of the consulting agreement.
As
of July 31, 2023, we also had warrants outstanding to purchase 300,000 shares of common stock at $6.56 per share, issued during fiscal
year 2021 and expiring on March 22, 2026.
Information
regarding the Company’s warrants for the nine months ended July 31, 2023 is as follows:
SCHEDULE OF WARRANTS ACTIVITY
| |
Shares | | |
Weighted Average Exercise Price Per Share | | |
Aggregate Intrinsic Value | |
Warrants outstanding at October 31, 2022 | |
| 300,000 | | |
$ | 6.56 | | |
| | |
Warrants outstanding and exercisable at July 31, 2023 | |
| 300,000 | | |
$ | 6.56 | | |
$ | 0 | |
The
following table summarizes information about the Company’s outstanding and exercisable warrants as of July 31, 2023:
SCHEDULE OF OUTSTANDING AND EXERCISABLE
Range of Exercise
Prices | | |
Number Outstanding and Exercisable | | |
Weighted Average Remaining Contractual Life (in
years) | | |
Weighted Average Exercise
Price | |
$ | 6.56 | | |
| 300,000 | | |
| 2.6 | | |
$ | 6.56 | |
4.
FAIR VALUE MEASUREMENTS
US
GAAP defines fair value and establishes a framework for measuring fair value. We have categorized our financial assets and liabilities,
based on the priority of the inputs to the valuation technique, into a three-level fair value hierarchy as set forth below. If the inputs
used to measure the financial instruments fall within different levels of the hierarchy, the categorization is based on the lowest level
input that is significant to the fair value measurement of the instrument.
Financial
assets and liabilities recorded in the accompanying condensed consolidated balance sheets are categorized based on the inputs to the
valuation techniques as follows:
Level
1 – Financial instruments 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 instruments 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 instruments 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 instruments.
The
following table presents the hierarchy for our financial assets measured at fair value on a recurring basis as of July 31, 2023 (in thousands):
SCHEDULE OF FAIR VALUE MEASUREMENTS
| |
Level 1 | | |
Level 2 | | |
Level 3 | | |
Total | |
Money market funds: | |
| | | |
| | | |
| | | |
| | |
Cash equivalents | |
$ | 1,070 | | |
$ | - | | |
$ | - | | |
$ | 1,070 | |
Certificates of deposit: | |
| | | |
| | | |
| | | |
| | |
Cash equivalents | |
| - | | |
| 1,981 | | |
| - | | |
| 1,981 | |
Short-term investments | |
| - | | |
| 6,850 | | |
| - | | |
| 6,850 | |
U.S. treasury bills: | |
| | | |
| | | |
| | | |
| | |
Short-term investments | |
| - | | |
| 15,486 | | |
| - | | |
| 15,486 | |
Total financial assets | |
$ | 1,070 | | |
$ | 24,317 | | |
$ | - | | |
$ | 25,387 | |
The
following table presents the hierarchy for our financial assets measured at fair value on a recurring basis as of October 31, 2022 (in
thousands):
| |
Level 1 | | |
Level 2 | | |
Level 3 | | |
Total | |
Money market funds: | |
| | | |
| | | |
| | | |
| | |
Cash equivalents | |
$ | 11,175 | | |
$ | - | | |
$ | - | | |
$ | 11,175 | |
Certificates of deposit: | |
| | | |
| | | |
| | | |
| | |
Cash equivalents | |
| - | | |
| 1,000 | | |
| - | | |
| 1,000 | |
Short term investments | |
| - | | |
| 13,700 | | |
| - | | |
| 13,700 | |
U.S. treasury bills | |
| | | |
| | | |
| - | | |
| | |
Short-term investments | |
| - | | |
| 3,627 | | |
| - | | |
| 3,627 | |
Total financial assets | |
$ | 11,175 | | |
$ | 18,327 | | |
$ | - | | |
$ | 29,502 | |
Our
non-financial assets that are measured at fair value on a non-recurring basis are property and equipment and other assets which are measured
using fair value techniques whenever events or changes in circumstances indicate a condition of impairment exists. The estimated fair
value of prepaid expenses and other current assets, accounts payable and accrued expenses approximates their individual carrying amounts
due to the short-term nature of these measurements. The carrying value of cash equivalents approximates fair value.
5.
ACCRUED EXPENSES
Accrued
expenses consist of the following as of:
SCHEDULE OF ACCRUED EXPENSES
| |
July 31, 2023 | | |
October 31, 2022 | |
| |
(in thousands) | |
Payroll and related expenses | |
$ | 977 | | |
$ | 492 | |
Accrued royalty and contingent legal fees | |
| 626 | | |
| 577 | |
Accrued collaborative research expenses | |
| 99 | | |
| - | |
Accrued other | |
| 10 | | |
| 26 | |
Accrued
expenses | |
$ | 1,712 | | |
$ | 1,095 | |
6.
NET LOSS PER SHARE OF COMMON STOCK
Basic
net loss per common share (“Basic EPS”) is computed by dividing net loss by the weighted average number of common shares
outstanding. Diluted net loss per common share (“Diluted EPS”) is computed by dividing net loss by the weighted average number
of common shares and dilutive common share equivalents and convertible securities then outstanding. Diluted EPS for all periods presented
is the same as Basic EPS, as the inclusion of the effect of common share equivalents then outstanding would be anti-dilutive. For this
reason, excluded from the calculation of Diluted EPS for the nine months ended July 31, 2023 and 2022, were stock options to purchase
11,473,236 and 11,094,104 shares, respectively, and warrants to purchase 300,000 and 300,000 shares, respectively.
7.
EFFECT OF RECENTLY ADOPTED AND ISSUED PRONOUNCEMENTS
In
August 2020, the FASB issued Accounting Standards Update 2020-06 (“ASU 2020-06”), Accounting for Convertible Instruments
and Contracts in an Entity’s Own Equity. The amendments in ASU 2020-06 include guidance on convertible instruments and the derivative
scope exception for contracts in an entity’s own equity and simplifies the accounting for convertible instruments which include
beneficial conversion features or cash conversion features by removing certain separation models in Subtopic 470-20. Additionally, ASU
2020-06 will require entities to use the “if-converted” method when calculating diluted earnings per share for convertible
instruments. The amendments in this update are effective for fiscal years beginning after December 15, 2021, including interim periods
within those fiscal years. The adoption of this standard did not have a material impact on our consolidated financial statements and
related disclosures.
In
May 2021, the FASB issued Accounting Standards Update 2021-04 (“ASU 2021-04”), Issuer’s Accounting for Certain Modifications
or Exchanges of Freestanding Equity-Classified Written Call Options. The guidance in ASU 2021-04 requires the issuer to treat a modification
of an equity-classified written call option (the “option”) that does not cause the option to become liability-classified
as an exchange of the original option for a new option. This guidance applies whether the modification is structured as an amendment
to the terms and conditions of the option or as termination of the original option and issuance of a new option. The amendments in this
update are effective for fiscal years beginning after December 15, 2021, including interim periods within those fiscal years. The adoption
of this standard did not have a material impact on our consolidated financial statements and related disclosures.
In
October 2021, the FASB issued Accounting Standards Update 2021-08, Business Combinations (Topic 805): Accounting for Contract Assets
and Contract Liabilities from Contracts with Customers, to require that an acquirer recognize and measure contract assets and contract
liabilities acquired in a business combination in accordance with Topic 606, Revenue from Contracts with Customers. At the acquisition
date, an acquirer should account for the related revenue contracts in accordance with Topic 606 as if it had originated the contracts.
The amendments in this update should be applied prospectively and are effective for fiscal years beginning after December 15, 2022, including
interim periods within those fiscal years. We do not expect the adoption of this standard to have a material impact on our consolidated
financial statements and related disclosures.
8. INCOME
TAXES
We
recognize deferred tax assets and liabilities for the estimated future tax effects of events that have been recognized in our financial
statements or tax returns. Under this method, deferred tax assets and liabilities are determined based on the difference between the
financial statement and tax bases of assets and liabilities using enacted tax rates in effect in the years in which the differences are
expected to reverse. A valuation allowance is established, when necessary, to reduce deferred tax assets to the amount expected to be
realized. We have provided a full valuation allowance against our deferred tax asset due to our historical pre-tax losses and the uncertainty
regarding the realizability of these deferred tax assets.
We
have substantial net operating loss carryforwards for Federal and California income tax returns. These net operating loss carryforwards
could be subject to limitations under Internal Revenue Code section 382, the effects of which have not been determined by the Company.
We have no unrecognized income tax benefits as of July 31, 2023 and October 31, 2022 and we account for interest and penalties related
to income tax matters, if any, in general and administrative expenses.
9. 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 was to expire on September 30, 2021. Effective August 17, 2021, the lease
was amended to extend the expiration date to September 30, 2024, with an option to extend the lease an additional two years. 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. The amendment to the lease resulted in a right-of-use asset and lease liability of approximately $260,000
with a discount rate of 10%. Rent expense was approximately $17,000 and $17,000, respectively, for the three months ended July 31, 2023
and 2022, and approximately $50,000 and $50,000, respectively, for the nine months ended July 31, 2023 and 2022.
For
operating leases, the lease liability is initially measured at the present value of the unpaid lease payments. The remaining 38-month
lease term as of July 31, 2023 for the Company’s lease includes the noncancelable period of the lease and the additional two-year
option period that the Company expects to exercise. All right-of-use assets are reviewed for impairment when indications of impairment
are present.
As
of July 31, 2023, the annual minimum future lease payments of our operating lease liabilities were as follows (in thousands):
SCHEDULE OF MINIMUM LEASE PAYMENTS
For Periods Ended October 31, | |
Operating Leases | |
2023 | |
$ | 17 | |
2024 | |
| 67 | |
2025 | |
| 70 | |
2026 | |
| 65 | |
Total future minimum lease payments, undiscounted | |
| 219 | |
Less: Imputed interest | |
| 32 | |
Present value of future minimum lease payments | |
$ | 187 | |
10. COMMITMENTS
AND CONTINGENCES
Litigation
Matters
Other
than lawsuits related to the enforcement of our patent rights, we are not a party to any material pending legal proceedings, nor are
we 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.
11.
SEGMENT INFORMATION
We
follow the accounting guidance of ASC 280 “Segment Reporting” (“ASC 280”). Reportable operating segments are
determined based on the management approach. The management approach, as defined by ASC 280, is based on the way that the chief operating
decision-maker organizes the segments within an enterprise for making operating decisions and assessing performance. While our results
of operations are primarily reviewed on a consolidated basis, the chief operating decision-maker manages the enterprise in four reportable
segments, each with different operating and potential revenue generating characteristics: (i) CAR-T Therapeutics, (ii) Cancer Vaccines,
(iii) Anti-Viral Therapeutics and (iv) Other. The following represents selected financial information for our segments for the three
and nine months ended July 31, 2023 and 2022 and as of July 31, 2023 and October 31, 2022, in thousands:
SCHEDULE OF SEGMENT INFORMATION
| |
2023 | | |
2022 | | |
2023 | | |
2022 | |
| |
For the Three Months Ended
July 31, | | |
For the Nine Months Ended
July 31, | |
| |
2023 | | |
2022 | | |
2023 | | |
2022 | |
Net Loss: | |
| | | |
| | | |
| | | |
| | |
CAR-T Therapeutics | |
$ | (1,091 | ) | |
$ | (965 | ) | |
$ | (2,999 | ) | |
$ | (3,975 | ) |
Cancer Vaccines | |
| (1,390 | ) | |
| (903 | ) | |
| (3,261 | ) | |
| (3,684 | ) |
Anti-Viral Therapeutics | |
| (62 | ) | |
| (904 | ) | |
| (960 | ) | |
| (2,565 | ) |
Other | |
| (5 | ) | |
| (3 | ) | |
| 11 | | |
| (18 | ) |
Total | |
$ | (2,548 | ) | |
$ | (2,775 | ) | |
$ | (7,209 | ) | |
$ | (10,242 | ) |
| |
| | | |
| | | |
| | | |
| | |
Total operating costs and expenses | |
$ | 2,844 | | |
$ | 2,797 | | |
$ | 8,170 | | |
$ | 10,266 | |
Less non-cash share-based compensation | |
| (1,217 | ) | |
| (1,446 | ) | |
| (3,507 | ) | |
| (5,546 | ) |
Operating costs and expenses excluding non-cash share-based compensation | |
$ | 1,627 | | |
$ | 1,351 | | |
$ | 4,663 | | |
$ | 4,720 | |
Operating costs and expenses excluding non-cash share-based compensation: | |
| | | |
| | | |
| | | |
| | |
CAR-T Therapeutics | |
$ | 713 | | |
$ | 421 | | |
$ | 1,930 | | |
$ | 1,823 | |
Cancer Vaccines | |
| 855 | | |
| 376 | | |
| 1,966 | | |
| 1,571 | |
Anti-Viral Therapeutics | |
| 55 | | |
| 552 | | |
| 572 | | |
| 1,312 | |
Other | |
| 4 | | |
| 2 | | |
| 195 | | |
| 14 | |
Total | |
$ | 1,627 | | |
$ | 1,351 | | |
$ | 4,663 | | |
$ | 4,720 | |
| |
July 31, 2023 | | |
October 31, 2022 | |
Total assets: | |
| | | |
| | |
CAR-T Therapeutics | |
$ | 11,640 | | |
$ | 16,921 | |
Cancer Vaccines | |
| 13,968 | | |
| 9,442 | |
Anti-Viral Therapeutics | |
| 898 | | |
| 3,811 | |
Other | |
| 72 | | |
| 238 | |
Total | |
$ | 26,578 | | |
$ | 30,412 | |
Operating
costs and expenses excluding non-cash share-based compensation is the measurement the chief operating decision-maker uses in managing
the enterprise.
The
Company’s consolidated revenue of $210,000 and inventor royalties, contingent legal fees, litigation and licensing expense of $161,000
for the nine months ended July 31, 2023 were solely related to our encrypted audio/video conference calling technology, which is included
in our Other segment. All our revenue is generated domestically (United States) based on the country in which the licensee is located.
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, 2022 and the condensed consolidated financial statements included in this Report. Except as required by applicable law, including
the securities laws of the United States, we undertake no obligation to publicly update or revise any forward-looking statements, whether
as a result of new information, future events or otherwise. You are cautioned not to unduly rely on such forward-looking statements when
evaluating the information presented in this Report.
GENERAL
We
discuss the description of our business in the Notes to our Condensed Consolidated Financial Statements.
RESULTS
OF OPERATIONS
Three
months ended July 31, 2023 compared with three months ended July 31, 2022
Revenue
We
had no revenue during the three months ended July 31, 2023 and 2022.
Over
the past several years, our revenue, if any, was derived from technology licensing and the sale of patented technologies, including revenue
from the settlement of litigation. We have not generated any revenue to date from our therapeutics or vaccine programs. In addition,
while we pursue our therapeutics and vaccine programs, we may also make investments in and form new companies to develop additional emerging
technologies. We do not expect to begin generating revenue with respect to any of our current therapy or vaccine programs in the near
term. We intend to achieve a profitable outcome by eventually licensing our technologies to large pharmaceutical companies that have
the resources and infrastructure in place to manufacture, market and sell our technologies as therapeutics or vaccines. The eventual
licensing of any of our technologies may take several years, if it is to occur at all, and may depend on positive results from human
clinical trials.
Inventor
Royalties, Contingent Legal Fees, Litigation and Licensing Expenses
We
had no inventor royalties, contingent legal fees, litigation and licensing expenses during the three-month periods ended July 31, 2023
and 2022.
Research
and Development Expenses
Research
and development expenses incurred in the three months ended July 31, 2023 associated with each of our development programs consisted
of approximately $616,000 for cancer vaccines, approximately $472,000 for CAR-T therapeutics and $0 for anti-viral therapeutics. As of
March 9, 2023, we paused further development of our COVID-19 anti-viral therapeutic program. While our compounds have shown promise in
head-to-head in vitro analysis against Pfizer’s authorized oral treatment, results of additional animal studies indicate
that there is not sufficient oral bioavailability, and it is unclear whether an orally delivered treatment may be developed. We do not
currently believe that there is a viable market for an injectable treatment given the current oral treatments available. Furthermore,
we believe the needed additional investment in research for alternative delivery methods would divert resources from more promising projects.
We continue to prosecute our U.S. patent applications of this technology and may decide to restart development at some time in the future.
Research
and development expenses are related to the development of our cancer therapeutics and vaccine programs and our anti-viral drug program,
and decreased by approximately $357,000 to approximately $1,088,000 in the three months ended July 31, 2023, from approximately $1,445,000
in the three months ended July 31, 2022. The decrease in research and development expenses was primarily due to a decrease in outside
research and development expense related to our anti-viral drug program of approximately $289,000, a decrease in employee stock option
compensation expense of approximately $190,000, and a decrease in stock option compensation for consultants of approximately $62,000,
offset by an increase of approximately $81,000 in outside research and development related to our CAR-T therapeutics program, and an
increase of approximately $80,000 in employee compensation and related costs, other than stock option compensation expense.
General
and Administrative Expenses
General
and administrative expenses increased by approximately $404,000 to approximately $1,756,000 in the three months ended July 31, 2023,
from approximately $1,352,000 in the three months ended July 31, 2022. The increase in general and administrative expenses was
primarily due to an increase in employee compensation and related costs, other than stock option compensation expense of
approximately $138,000, an increase in directors stock option expense of approximately $92,000, an increase in directors
compensation, other than stock option compensation expense of approximately $87,000, an increase in investor and public relations
expense of approximately $84,000, and an increase in consultant expenses of approximately $51,000, offset by a decrease in employee
stock option compensation expense of approximately $76,000.
Interest
Income
Interest
income was approximately $296,000 and $22,000 in the three-month periods ended July 31, 2023 and 2022, respectively. The increase in
interest income was due primarily to an increase in interest rates on our cash, cash equivalents and short-term investments.
Net
Loss Attributable to Noncontrolling Interest
The
net loss attributable to noncontrolling interest, representing Wistar’s 5% ownership interest in Certainty’s net loss, was
approximately $37,000 and $29,000, respectively, in the three months ended July 31, 2023 and 2022.
Nine
months ended July 31, 2023 compared with nine months ended July 31, 2022
Revenue
For
the nine months ended July 31, 2023, we recorded revenue of approximately $210,000 from one license agreement relating to our legacy
business. 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. We had no revenue during the nine months ended July 31, 2022.
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, nor do we
expect these activities to require material financial resources or attention of senior management.
We
have not generated any revenue to date from our therapeutics or vaccine programs. In addition, while we pursue our therapeutics and vaccine
programs, we may also make investments in and form new companies to develop additional emerging technologies. We do not expect to begin
generating revenue with respect to any of our current therapy or vaccine programs in the near term. We intend to achieve a profitable
outcome by eventually licensing our technologies to large pharmaceutical companies that have the resources and infrastructure in place
to manufacture, market and sell our technologies as therapeutics or vaccines. The eventual licensing of any of our technologies may take
several years, if it is to occur at all, and may depend on positive results from human clinical trials.
Inventor
Royalties, Contingent Legal Fees, Litigation and Licensing Expenses
Inventor
royalties, contingent legal fees, litigation and licensing expenses for the nine months ended July 31, 2023 were approximately $161,000.
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. We had no inventor royalties,
contingent legal fees, litigation and licensing expenses during the nine-month period ended July 31, 2022.
Research
and Development Expenses
Research
and development expenses incurred in the nine months ended July 31, 2023 associated with each of our development programs consisted of
approximately $1,595,000 for cancer vaccines, approximately $1,321,000 for CAR-T therapeutics and approximately $238,000 for anti-viral
therapeutics. As of March 9, 2023, we paused further development of our COVID-19 anti-viral therapeutic program. While our compounds
have shown promise in head-to-head in vitro analysis against Pfizer’s authorized oral treatment, results of additional animal studies
indicate that there is not sufficient oral bioavailability, and it is unclear whether an orally delivered treatment may be developed.
We do not currently believe that there is a viable market for an injectable treatment given the current oral treatments available. Furthermore,
we believe the needed additional investment in research for alternative delivery methods would divert resources from more promising projects.
We continue to prosecute our U.S. patent applications of this technology and may decide to restart development at some time in the future.
Research
and development expenses are related to the development of our cancer therapeutics and vaccine programs and our anti-viral drug program,
and decreased by approximately $1,864,000 to approximately $3,154,000 in the nine months ended July 31, 2023, from approximately $5,018,000
in the nine months ended July 31, 2022. The decrease in research and development expenses was primarily due to a decrease in employee
stock option compensation expense of approximately $1,347,000, a decrease in outside research and development expense related to our
anti-viral drug program of approximately $437,000, and a decrease in consultant stock option and warrant expense of approximately $151,000,
offset by an increase in employee compensation and related costs, other than stock option compensation expense, of approximately $145,000.
General
and Administrative Expenses
General
and administrative expenses decreased by approximately $393,000 to approximately $4,855,000 in the nine months ended July 31, 2023, from
approximately $5,248,000 in the nine months ended July 31, 2022. The decrease in general and administrative expenses was primarily due
to a decrease in employee stock option compensation expense of approximately $369,000, a decrease in consultant warrant expense of approximately
$220,000, and a decrease in patent related costs of approximately $124,000, offset by an increase in employee compensation and related costs, other than stock
option compensation expense of approximately $120,000 and an increase in directors stock option compensation
expense of approximately $88,000.
Interest
Income
Interest
income was approximately $751,000 and $24,000 in the nine-month periods ended July 31, 2023 and 2022, respectively. The increase in interest
income was due primarily to an increase in interest rates on our cash, cash equivalents and short-term investments.
Net
Loss Attributable to Noncontrolling Interest
The
net loss attributable to noncontrolling interest, representing Wistar’s 5% ownership interest in Certainty’s net loss, was
approximately $88,000 and $123,000, respectively, in the nine months ended July 31, 2023 and 2022.
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 6, 2023, we believe that our existing cash, cash equivalents, short-term investments
and expected cash flows will be sufficient to fund our activities for at least the next twelve months. We have implemented a business
model that conserves funds by collaborating with third parties to develop our technologies. However, our projections of future cash needs
and cash flows may differ from actual results. If current cash on hand, cash equivalents, short-term investments and cash that may be
generated from our business operations are insufficient to continue to operate our business, or if we elect to invest in or acquire a
company or companies or new technology or technologies that are synergistic with or complementary to our technologies, we may be required
to obtain more working capital. Under our at-the-market equity program as of July 31, 2023, we may sell up to $100 million of common
stock. We did not sell any shares under our at-the-market equity program during the three and nine months ended July 31, 2023. We may
seek to obtain working capital during our fiscal year 2023 or thereafter through sales of our equity securities or public or private
debt from various financial institutions where possible. We cannot be certain that additional funding will be available on acceptable
terms, or at all. If we do identify sources for additional funding, the sale of additional equity securities or convertible debt will
result in dilution to our stockholders. We can give no assurance that we will generate sufficient cash flows in the future to satisfy
our liquidity requirements or sustain future operations, or that other sources of funding, such as sales of equity or debt, would be
available or would be approved by our security holders, if needed, on favorable terms or at all. If we fail to obtain additional working
capital as and when needed, such failure could have a material adverse impact on our business, results of operations and financial condition.
Furthermore, such lack of funds may inhibit our ability to respond to competitive pressures or unanticipated capital needs, or may force
us to reduce operating expenses, which would significantly harm the business and development of operations.
During
the nine months ended July 31, 2023, cash used in operating activities was approximately $4,240,000. Cash used in investing activities
was approximately $5,009,000, resulting from the purchase of short-term investments totaling approximately $27,502,000, which was offset
by the proceeds on maturities of short-term investments of approximately $22,493,000. Cash provided by financing activities was approximately
$87,000, resulting from proceeds from exercise of stock options of approximately $81,000 and proceeds from the sale of common stock pursuant
to our employee stock purchase plan of approximately $6,000. Our cash and cash equivalents including short-term investments, at July
31, 2023 decreased approximately $4,153,000 to approximately $25,534,000 from approximately $29,687,000 at the end of fiscal year 2022.
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, 2022, 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.
Our
revenue recognition policy requires us 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, within 30 days of execution of the agreement, of contractually determined, one-time, paid-up
license fees in settlement of litigation and in consideration for the grant of certain intellectual property rights for patented technologies
owned or controlled by the Company. These arrangements typically include some combination of the following: (i) the grant of a non-exclusive,
retroactive and future license to manufacture and/or sell products covered by patented technologies owned or controlled by the Company,
(ii) a covenant-not-to-sue, (iii) the release of the licensee from certain claims, and (iv) the dismissal of any pending litigation.
In such instances, the intellectual property rights granted have been perpetual in nature, extending until the expiration of the related
patents. Pursuant to the terms of these agreements, we have no further obligations with respect to the granted intellectual property
rights, including no obligation to maintain or upgrade the technology, or provide future support or services. Licensees obtained control
of the intellectual property rights they have acquired upon execution of the agreement. Accordingly, the performance obligations from
these agreements were satisfied and 100% of the revenue was recognized upon the execution of the agreements.
Stock-Based
Compensation
The
compensation cost for service-based stock options granted to employees, directors and consultants is measured at the grant date, based
on the fair value of the award using the Black-Scholes pricing model, and is recognized as an expense on a straight-line basis over the
requisite service period (the vesting period of the stock option) which is one to four years. For employee options vesting if the trading
price of the Company’s common stock 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).
The
Black-Scholes pricing model and the Monte Carlo Simulation we use to estimate fair value requires valuation assumptions of expected term,
expected volatility, risk-free interest rates and expected dividend yield. The expected term of stock options represents the weighted
average period the stock options are expected to remain outstanding. For employees we use the simplified method, which is a weighted
average of the vesting term and contractual term, to determine expected term. The simplified method was adopted since we do not believe
that historical experience is representative of future performance because of the impact of the changes in our operations and the change
in terms from historical options. For consultants we use the contract term for expected term. Under the Black-Scholes pricing model,
we estimated the expected volatility of our shares of common stock based upon the historical volatility of our share price over a period
of time equal to the expected term of the grants. We estimated the risk-free interest rate based on the implied yield available on the
applicable grant date of a U.S. Treasury note with a term equal to the expected term of the underlying grants. We made the dividend yield
assumption based on our history of not paying dividends and our expectation not to pay dividends in the future.
We
will reconsider use of the Black-Scholes pricing model and the Monte Carlo Simulation if additional information becomes available in
the future that indicates another model would be more appropriate. If factors change and we employ different assumptions in future periods,
the compensation expense that we record may differ significantly from what we have recorded in the current period.
EFFECT
OF RECENTLY ISSUED PRONOUNCEMENTS
We
do not believe that any of the recently issued accounting pronouncements will have a material effect on the Company’s consolidated
financial statements. See Note 7 to the accompanying condensed consolidated financial statements.
Item
3. Quantitative and Qualitative Disclosures About Market Risk.
As
of July 31, 2023, 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 Chief Executive Officer and
our Chief Financial Officer, of the effectiveness of the design and operation of our disclosure controls and procedures pursuant to Rule
13(a)-15(b) of the Exchange Act. Based upon that evaluation, our Chief Executive Officer and our 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 2023 that has materially affected,
or is reasonably likely to materially affect, our internal control over financial reporting.
PART
II. OTHER INFORMATION
Item
1. Legal Proceedings.
Other
than lawsuits related to the enforcement of our patent rights, we are not a party to any material pending legal proceedings, nor are
we aware of any pending litigation or legal proceeding against us that would have a material adverse effect upon our results of operations
or financial condition.
Item
1A. Risk Factors.
There
have been no material changes in our risk factors from those disclosed in our Annual Report on Form 10-K for the fiscal year ended October
31, 2022.
Item
2. Unregistered Sales of Equity Securities and Use of Proceeds.
During
the nine months ended July 31, 2023, the Company issued an aggregate of 17,554 shares of our common stock to companies in payment of
investor relations services. The common stock was issued in reliance on an exemption from registration under Section 4(a)(2) of the Securities
Act as they were issued to recipients, without a view to distribution, and were not issued through any general solicitation or advertisement.
Item
3. Defaults Upon Senior Securities. None.
Item
4. Mine Safety Disclosures. Not Applicable.
Item
5. Other Information. None.
Item
6. Exhibits.
31.1 |
|
Certification of Chief Executive Officer, pursuant to Section 302 of the Sarbanes-Oxley Act of 2002, dated September 6, 2023. |
31.2 |
|
Certification of Chief Financial Officer, pursuant to Section 302 of the Sarbanes-Oxley Act of 2002, dated September 6, 2023. |
32.1 |
|
Statement of Chief Executive Officer, pursuant to Section 1350 of Title 18 of the United States Code, dated September 6, 2023. |
32.2 |
|
Statement of Chief Financial Officer, pursuant to Section 1350 of Title 18 of the United States Code, dated September 6, 2023. |
101.INS |
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Inline
XBRL Instance Document |
101.SCH |
|
Inline
XBRL Taxonomy Extension Schema Document |
101.CAL |
|
Inline
XBRL Taxonomy Extension Calculation Linkbase Document |
101.DEF |
|
Inline
XBRL Taxonomy Extension Definition Linkbase Document |
101.LAB |
|
Inline
XBRL Taxonomy Extension Label Linkbase Document |
101.PRE |
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Inline
XBRL Taxonomy Extension Presentation Linkbase Document |
104 |
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Cover
Page Interactive Data File (embedded within the Inline XBRL document) |
SIGNATURES
Pursuant
to the requirements of the Securities Exchange Act of 1934, the registrant has duly caused this Report to be signed on its behalf by
the undersigned, thereunto duly authorized.
|
ANIXA
BIOSCIENCES, INC. |
|
|
|
|
By: |
/s/
Dr. Amit Kumar |
|
|
Dr.
Amit Kumar |
|
|
Chairman
and Chief Executive Officer |
September
6, 2023 |
|
(Principal
Executive Officer) |
|
|
|
|
By: |
/s/
Michael J. Catelani |
|
|
Michael
J. Catelani |
|
|
President,
Chief Operating Officer and |
|
|
Chief
Financial Officer |
|
|
(Principal
Financial and |
September
6, 2023 |
|
Accounting
Officer) |
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
and Chief Executive Officer |
September
6, 2023 |
|
(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 |
|
|
President,
Chief Operating Officer and |
|
|
Chief
Financial Officer |
|
|
(Principal
Financial and |
September
6, 2023 |
|
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 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, 2023 (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
and Chief Executive Officer |
September
6, 2023 |
|
(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 President, Chief Operating Officer and
Chief Financial Officer of Anixa Biosciences, Inc., hereby certifies that:
1. |
The
Company’s Form 10-Q Quarterly Report for the period ended July 31, 2023 (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/
Michael J. Catelani |
|
|
Michael
J. Catelani |
|
|
President,
Chief Operating Officer and |
|
|
Chief
Financial Officer |
|
|
(Principal
Financial and |
September
6, 2023 |
|
Accounting
Officer) |
v3.23.2
Cover - shares
|
9 Months Ended |
|
Jul. 31, 2023 |
Sep. 06, 2023 |
Cover [Abstract] |
|
|
Document Type |
10-Q
|
|
Amendment Flag |
false
|
|
Document Quarterly Report |
true
|
|
Document Transition Report |
false
|
|
Document Period End Date |
Jul. 31, 2023
|
|
Document Fiscal Period Focus |
Q3
|
|
Document Fiscal Year Focus |
2023
|
|
Current Fiscal Year End Date |
--10-31
|
|
Entity File Number |
001-37492
|
|
Entity Registrant Name |
ANIXA
BIOSCIENCES, INC.
|
|
Entity Central Index Key |
0000715446
|
|
Entity Tax Identification Number |
11-2622630
|
|
Entity Incorporation, State or Country Code |
DE
|
|
Entity Address, Address Line One |
3150
Almaden Expressway
|
|
Entity Address, Address Line Two |
Suite 250
|
|
Entity Address, City or Town |
San
Jose
|
|
Entity Address, State or Province |
CA
|
|
Entity Address, Postal Zip Code |
95118
|
|
City Area Code |
(408)
|
|
Local Phone Number |
708-9808
|
|
Title of 12(b) Security |
Common
Stock, par value $.01 per share
|
|
Trading Symbol |
ANIX
|
|
Security Exchange Name |
NASDAQ
|
|
Entity Current Reporting Status |
Yes
|
|
Entity Interactive Data Current |
Yes
|
|
Entity Filer Category |
Non-accelerated Filer
|
|
Entity Small Business |
true
|
|
Entity Emerging Growth Company |
false
|
|
Entity Shell Company |
false
|
|
Entity Common Stock, Shares Outstanding |
|
31,070,022
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v3.23.2
Condensed Consolidated Balance Sheets (Unaudited) - USD ($) $ in Thousands |
Jul. 31, 2023 |
Oct. 31, 2022 |
Current assets: |
|
|
Cash and cash equivalents |
$ 3,198
|
$ 12,360
|
Short-term investments |
22,336
|
17,327
|
Receivables |
334
|
47
|
Prepaid expenses and other current assets |
532
|
466
|
Total current assets |
26,400
|
30,200
|
Operating lease right-of-use asset |
178
|
212
|
Total assets |
26,578
|
30,412
|
Current liabilities: |
|
|
Accounts payable |
94
|
265
|
Accrued expenses |
1,712
|
1,726
|
Operating lease liability |
51
|
46
|
Total current liabilities |
1,857
|
2,037
|
Operating lease liability, non-current |
136
|
175
|
Total liabilities |
1,993
|
2,212
|
Commitments and contingencies (Note 10) |
|
|
Shareholders’ equity: |
|
|
Preferred stock, value |
|
|
Common stock, par value $.01 per share; 100,000,000 shares authorized; 31,017,770 and 30,913,902 shares issued and outstanding as of July 31, 2023 and October 31, 2022, respectively |
310
|
309
|
Additional paid-in capital |
250,716
|
247,123
|
Accumulated deficit |
(225,506)
|
(218,385)
|
Total shareholders’ equity |
25,520
|
29,047
|
Noncontrolling interest (Note 2) |
(935)
|
(847)
|
Total equity |
24,585
|
28,200
|
Total liabilities and equity |
26,578
|
30,412
|
Series A Convertible Preferred Stock [Member] |
|
|
Shareholders’ equity: |
|
|
Preferred stock, value |
|
|
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v3.23.2
Condensed Consolidated Balance Sheets (Unaudited) (Parenthetical) - $ / shares
|
Jul. 31, 2023 |
Oct. 31, 2022 |
Preferred stock, par value |
$ 100
|
$ 100
|
Preferred stock, shares authorized |
19,860
|
19,860
|
Preferred stock, shares issued |
0
|
0
|
Preferred stock, shares outstanding |
0
|
0
|
Common stock, par value |
$ 0.01
|
$ 0.01
|
Common stock, shares authorized |
100,000,000
|
100,000,000
|
Common stock, shares issued |
31,017,770
|
30,913,902
|
Common stock, shares outstanding |
31,017,770
|
30,913,902
|
Series A Convertible Preferred Stock [Member] |
|
|
Preferred stock, par value |
$ 100
|
$ 100
|
Preferred stock, shares authorized |
140
|
140
|
Preferred stock, shares issued |
0
|
0
|
Preferred stock, shares outstanding |
0
|
0
|
X |
- DefinitionFace amount or stated value per share of common stock.
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v3.23.2
Condensed Consolidated Statements of Operations (Unaudited) - USD ($) $ in Thousands |
3 Months Ended |
9 Months Ended |
Jul. 31, 2023 |
Jul. 31, 2022 |
Jul. 31, 2023 |
Jul. 31, 2022 |
Income Statement [Abstract] |
|
|
|
|
Revenue |
|
|
$ 210
|
|
Operating costs and expenses: |
|
|
|
|
Inventor royalties, contingent legal fees, litigation and licensing expenses |
|
|
161
|
|
Research and development expenses (including non-cash share-based compensation expenses of $520, $771, $1,517 and $3,014, respectively) |
1,088
|
1,445
|
3,154
|
5,018
|
General and administrative expenses (including non-cash share-based compensation expenses of $697, $675, $1,990 and $2,531, respectively) |
1,756
|
1,352
|
4,855
|
5,248
|
Total operating costs and expenses |
2,844
|
2,797
|
8,170
|
10,266
|
Loss from operations |
(2,844)
|
(2,797)
|
(7,960)
|
(10,266)
|
Interest income |
296
|
22
|
751
|
24
|
Net loss |
(2,548)
|
(2,775)
|
(7,209)
|
(10,242)
|
Less: Net loss attributable to noncontrolling interest |
(37)
|
(29)
|
(88)
|
(123)
|
Net loss attributable to common shareholders |
$ (2,511)
|
$ (2,746)
|
$ (7,121)
|
$ (10,119)
|
Net loss per common share attributable to common shareholders: |
|
|
|
|
Basic |
$ (0.08)
|
$ (0.09)
|
$ (0.23)
|
$ (0.33)
|
Diluted |
$ (0.08)
|
$ (0.09)
|
$ (0.23)
|
$ (0.33)
|
Weighted average common shares outstanding: |
|
|
|
|
Basic |
30,974
|
30,451
|
30,941
|
30,244
|
Diluted |
30,974
|
30,451
|
30,941
|
30,244
|
X |
- DefinitionTotal costs of sales and operating expenses for the period.
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3 Months Ended |
9 Months Ended |
Jul. 31, 2023 |
Jul. 31, 2022 |
Jul. 31, 2023 |
Jul. 31, 2022 |
Research and Development Expense [Member] |
|
|
|
|
Stock-based payment arrangement, expense |
$ 520
|
$ 771
|
$ 1,517
|
$ 3,014
|
General and Administrative Expense [Member] |
|
|
|
|
Stock-based payment arrangement, expense |
$ 697
|
$ 675
|
$ 1,990
|
$ 2,531
|
X |
- DefinitionAmount of expense for award under share-based payment arrangement. Excludes amount capitalized.
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Condensed Consolidated Statements of Equity (Unaudited) - USD ($) $ in Thousands |
Total |
Common Stock [Member] |
Additional Paid-in Capital [Member] |
Retained Earnings [Member] |
Total Shareholders Equity [Member] |
Noncontrolling Interest [Member] |
Balance at Oct. 31, 2021 |
$ 34,767
|
$ 301
|
$ 239,927
|
$ (204,790)
|
$ 35,438
|
$ (671)
|
Balance, shares at Oct. 31, 2021 |
|
30,050,894
|
|
|
|
|
Stock option compensation to employees and directors |
4,928
|
|
4,928
|
|
4,928
|
|
Common stock issued upon exercise of stock options and warrants |
830
|
$ 6
|
824
|
|
830
|
|
Common stock issued upon exercise of stock options and warrants, shares |
|
577,473
|
|
|
|
|
Common stock issued to consultants |
72
|
|
72
|
|
72
|
|
Common stock issued to consultants, shares |
|
22,662
|
|
|
|
|
Net loss |
(10,242)
|
|
|
(10,119)
|
(10,119)
|
(123)
|
Balance at Jul. 31, 2022 |
30,907
|
$ 307
|
246,303
|
(214,909)
|
31,701
|
(794)
|
Balance, shares at Jul. 31, 2022 |
|
30,653,418
|
|
|
|
|
Stock options and warrants issued to consultants |
546
|
|
546
|
|
546
|
|
Common stock issued pursuant to employee stock purchase plan |
6
|
|
6
|
|
6
|
|
Common stock issued pursuant to employee stock purchase plan, shares |
|
2,389
|
|
|
|
|
Balance at Apr. 30, 2022 |
31,406
|
$ 302
|
244,032
|
(212,163)
|
32,171
|
(765)
|
Balance, shares at Apr. 30, 2022 |
|
30,154,708
|
|
|
|
|
Stock option compensation to employees and directors |
1,329
|
|
1,329
|
|
1,329
|
|
Stock options issued to consultants |
109
|
|
109
|
|
109
|
|
Common stock issued upon exercise of stock options and warrants |
830
|
$ 5
|
825
|
|
830
|
|
Common stock issued upon exercise of stock options and warrants, shares |
|
496,048
|
|
|
|
|
Common stock issued to consultants |
8
|
|
8
|
|
8
|
|
Common stock issued to consultants, shares |
|
2,662
|
|
|
|
|
Net loss |
(2,775)
|
|
|
(2,746)
|
(2,746)
|
(29)
|
Balance at Jul. 31, 2022 |
30,907
|
$ 307
|
246,303
|
(214,909)
|
31,701
|
(794)
|
Balance, shares at Jul. 31, 2022 |
|
30,653,418
|
|
|
|
|
Balance at Oct. 31, 2022 |
28,200
|
$ 309
|
247,123
|
(218,385)
|
29,047
|
(847)
|
Balance, shares at Oct. 31, 2022 |
|
30,913,902
|
|
|
|
|
Stock option compensation to employees and directors |
3,265
|
|
3,265
|
|
3,265
|
|
Common stock issued upon exercise of stock options and warrants |
81
|
$ 1
|
80
|
|
81
|
|
Common stock issued upon exercise of stock options and warrants, shares |
|
84,411
|
|
|
|
|
Common stock issued to consultants |
67
|
|
67
|
|
67
|
|
Common stock issued to consultants, shares |
|
17,554
|
|
|
|
|
Net loss |
(7,209)
|
|
|
(7,121)
|
(7,121)
|
(88)
|
Balance at Jul. 31, 2023 |
24,585
|
$ 310
|
250,716
|
(225,506)
|
25,520
|
(935)
|
Balance, shares at Jul. 31, 2023 |
|
31,017,770
|
|
|
|
|
Stock options and warrants issued to consultants |
175
|
|
175
|
|
175
|
|
Common stock issued pursuant to employee stock purchase plan |
6
|
|
6
|
|
6
|
|
Common stock issued pursuant to employee stock purchase plan, shares |
|
1,903
|
|
|
|
|
Balance at Apr. 30, 2023 |
25,913
|
$ 310
|
249,496
|
(222,995)
|
26,811
|
(898)
|
Balance, shares at Apr. 30, 2023 |
|
30,958,665
|
|
|
|
|
Stock option compensation to employees and directors |
1,153
|
|
1,153
|
|
1,153
|
|
Stock options issued to consultants |
47
|
|
47
|
|
47
|
|
Common stock issued upon exercise of stock options and warrants |
3
|
|
3
|
|
3
|
|
Common stock issued upon exercise of stock options and warrants, shares |
|
55,029
|
|
|
|
|
Common stock issued to consultants |
17
|
|
17
|
|
17
|
|
Common stock issued to consultants, shares |
|
4,076
|
|
|
|
|
Net loss |
(2,548)
|
|
|
(2,511)
|
(2,511)
|
(37)
|
Balance at Jul. 31, 2023 |
$ 24,585
|
$ 310
|
$ 250,716
|
$ (225,506)
|
$ 25,520
|
$ (935)
|
Balance, shares at Jul. 31, 2023 |
|
31,017,770
|
|
|
|
|
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v3.23.2
Condensed Consolidated Statements of Cash Flows (Unaudited) - USD ($) $ in Thousands |
9 Months Ended |
Jul. 31, 2023 |
Jul. 31, 2022 |
Reconciliation of net loss to net cash used in operating activities: |
|
|
Net loss |
$ (7,209)
|
$ (10,242)
|
Stock option compensation to employees and directors |
3,265
|
4,928
|
Stock options and warrants issued to consultants |
175
|
546
|
Common stock issued to consultants |
67
|
72
|
Amortization of operating lease right-of-use asset |
34
|
31
|
Change in operating assets and liabilities: |
|
|
Receivables |
(288)
|
|
Prepaid expenses and other current assets |
(65)
|
(400)
|
Accounts payable |
(171)
|
91
|
Accrued expenses |
(14)
|
103
|
Operating lease liability |
(34)
|
(28)
|
Net cash used in operating activities |
(4,240)
|
(4,899)
|
Cash flows from investing activities: |
|
|
Disbursements to acquire short-term investments |
(27,502)
|
(11,159)
|
Proceeds from maturities of short-term investments |
22,493
|
10,348
|
Net cash used in investing activities |
(5,009)
|
(811)
|
Cash flows from financing activities: |
|
|
Proceeds from sale of common stock pursuant to employee stock purchase plan |
6
|
6
|
Proceeds from exercise of stock options |
81
|
830
|
Net cash provided by financing activities |
87
|
836
|
Net decrease in cash and cash equivalents |
(9,162)
|
(4,874)
|
Cash and cash equivalents at beginning of period |
12,360
|
29,128
|
Cash and cash equivalents at end of period |
$ 3,198
|
$ 24,254
|
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v3.23.2
BUSINESS AND FUNDING
|
9 Months Ended |
Jul. 31, 2023 |
Accounting Policies [Abstract] |
|
BUSINESS AND FUNDING |
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 vaccine programs include (i) the development of a preventative vaccine against triple
negative breast cancer (“TNBC”), the most lethal form of breast cancer, as well other forms of breast cancer and (ii) the
development of a preventative vaccine against ovarian cancer. Our therapeutics programs include (i) the development of a chimeric endocrine
receptor T-cell therapy, a novel form of chimeric antigen receptor T-cell (“CAR-T”) technology, initially focused on treating
ovarian cancer, which is being developed at our subsidiary, Certainty Therapeutics, Inc. (“Certainty”), and (ii) until March
2023, the development of anti-viral drug candidates for the treatment of COVID-19 focused on inhibiting certain protein functions of
the virus.
We
hold an exclusive worldwide, royalty-bearing license to use certain intellectual property owned or controlled by The Cleveland Clinic
Foundation (“Cleveland Clinic”) relating to certain breast cancer vaccine technology developed at Cleveland Clinic. Utilizing
this technology, we are working in collaboration with Cleveland Clinic to develop a method to vaccinate women against contracting breast
cancer, focused specifically on TNBC. The focus of this vaccine is a specific protein, α-lactalbumin, that is only expressed during
lactation in a healthy mother’s mammary tissue. This protein disappears when the mother is no longer lactating, but reappears in
many forms of breast cancer, especially TNBC. Studies have shown that vaccinating against this protein prevents breast cancer in mice.
Following
the U.S. Food and Drug Administration’s (“FDA”) authorization to proceed with clinical trials in December 2020, in
October 2021, we commenced dosing patients in a Phase 1 clinical trial of our breast cancer vaccine. This study, which is being funded
by a U.S. Department of Defense grant, is a multiple-ascending dose Phase 1 trial to determine the maximum tolerated dose (“MTD”)
of the vaccine in patients with early-stage, triple-negative breast cancer as well as monitor immune response. The study is being conducted
at Cleveland Clinic. The first segment of the study, Phase 1a, will consist of 18 to 24 patients who have completed treatment for early-stage,
triple-negative breast cancer within the past three years and are currently tumor-free but at high risk for recurrence. Studies show
that 42% of TNBC patients will have a recurrence of their cancer, with most of the recurrences occurring in the first two to three years
after standard of care treatment. During the course of the Phase 1a study, participants will receive three vaccinations, each two weeks
apart, and will be closely monitored for side effects and immune response. In April 2023, we presented the immunological data collected
to date at the annual meeting of the American Association for Cancer Research. The data presented show that in the vaccinated women who
had been tested to date, various levels of antigen-specific T cell responses were observed at all dose levels. In January 2023, the number
of participants in each dose cohort was expanded, and as of August 2023, we have completed vaccinating all patients in these expanded
cohorts. The patient blood samples are currently being analyzed, and we anticipate presenting data from all Phase 1a trial participants
vaccinated to date at the San Antonio Breast Cancer Symposium in December 2023. In the coming months, we will begin vaccinating participants
in two additional dose cohorts at dose levels higher than the currently determined maximum tolerated dose and lower than the highest
dose where we saw dose limiting toxicity. Further, we have commenced recruitment for participants in the second segment of the trial,
Phase 1b, that will include participants who have never had cancer, but carry certain genetic mutations that indicate a greater risk
of developing TNBC in the future. Finally, we have also commenced recruitment for participants in the third segment of the trial, Phase
1c, that will include participants who are currently undergoing treatment with pembrolizumab (Keytruda®).
In
November 2020, we executed a license agreement with Cleveland Clinic pursuant to which the Company was granted an exclusive worldwide,
royalty-bearing license to use certain intellectual property owned or controlled by Cleveland Clinic relating to certain ovarian cancer
vaccine technology. This technology pertains to among other things, the use of vaccines for the treatment or prevention of ovarian cancers
which express the anti-Mullerian hormone receptor 2 protein containing an extracellular domain (“AMHR2-ED”). In healthy tissue,
this protein regulates growth and development of egg-containing follicles in the ovary. While expression of AMHR2-ED naturally and markedly
declines during menopause, this protein is expressed at high levels in the ovaries of postmenopausal women with ovarian cancer. Researchers
at Cleveland Clinic believe that a vaccine targeting AMHR2-ED could prevent the occurrence of ovarian cancer. We entered into a joint
development agreement with Cleveland Clinic to advance this vaccine toward human clinical testing.
In
May 2021, Cleveland Clinic was granted an award for our ovarian cancer vaccine technology by the National Cancer Institute’s (“NCI”)
PREVENT program. The NCI is a part of the National Institutes of Health (“NIH”). The PREVENT program is a peer-reviewed agent
development program designed to support pre-clinical development of innovative interventions and biomarkers for cancer prevention and
interception towards clinical trials. The scientific and financial resources of the PREVENT program are being used for our ovarian cancer
vaccine technology to perform virtually all pre-clinical research and development, manufacturing and IND-enabling studies. This work
is being performed at NCI facilities, by NCI scientific staff and with NCI financial resources and will require no material financial
expenditures by the Company, nor the transfer of any rights of the Company’s assets.
Our
subsidiary, 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”), the nation’s first independent
biomedical research institute and a leading NCI designated cancer research center, relating to Wistar’s chimeric endocrine receptor
targeted therapy technology. We have initially focused on the development of a treatment for ovarian cancer, but we also may pursue applications
of the technology for the development of treatments for additional solid tumors. The license agreement requires Certainty to make certain
cash and equity payments to Wistar upon achievement of specific development milestones. With respect to Certainty’s equity obligations
to Wistar, Certainty issued to Wistar shares of its common stock equal to five percent (5%) of the common stock of Certainty.
Certainty,
in collaboration with the H. Lee Moffitt Cancer Center and Research Institute, Inc. (“Moffitt”), has begun human clinical
testing of the CAR-T technology licensed by Certainty from Wistar aimed initially at treating ovarian cancer. We received authorization
from the FDA in August 2021, to commence enrollment and treatment of patients in a Phase 1 clinical trial. We began patient recruitment
for the trial in March 2022, and in August 2022, we treated the first patient in the trial, and the treatment was well-tolerated by the
patient. Further, in May 2023 and August 2023, we treated the second and third patients in the trial, respectively, at the same dose
level as the first patient, and the treatment appears to have been well-tolerated by both patients. We anticipate that we will begin
enrolling the successive patient cohort, that we expect to give a three-times higher dose of cells, in the fourth quarter of 2023. This
study is a dose-escalation trial with two arms based on delivery method—intraperitoneal or intravenous—to determine the maximum
tolerated dose in patients with recurrent epithelial ovarian cancer and to assess persistence, expansion and efficacy of the modified
T-cells. The study is being conducted at Moffitt and will consist of 24 to 48 patients who have received at least two prior lines of
chemotherapy. The study is estimated to be completed in two to four years depending on multiple factors including when maximum tolerated
dose is reached, the rate of patient enrollment, and how long we maintain the two different delivery methods.
In
April 2020, we entered into a collaboration with OntoChem GmbH (“OntoChem”) which was later assigned to MolGenie GmbH (“MolGenie”),
a company spun-out from OntoChem focused on drug discovery and development, to discover and ultimately develop anti-viral drug candidates
against COVID-19. Through this collaboration, we identified compounds that appeared to be effective in disrupting the main protease of
SARS-CoV-2, the virus that causes the disease COVID-19. While our compounds have shown promise as an effective treatment, results of
animal studies indicate that there is not sufficient oral bioavailability, and it is unclear whether an orally delivered treatment may
be developed. We do not currently believe that there is a viable market for an injectable treatment given the current oral treatments
available. Furthermore, we believe the needed additional investment in research for alternative delivery methods would divert resources
from more promising projects. Therefore, on March 9, 2023, we decided to pause further development of our COVID-19 therapeutic. We continue
to prosecute our U.S. patent applications of this technology and may decide to restart development at some time in the future.
Over
the next several quarters, we expect the development of our vaccines and therapeutics to be the primary focus of the Company. As part
of our legacy operations, the Company remains engaged in limited patent licensing activities of its various patent portfolios. 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 (during the nine months ended July 31, 2023, we derived approximately $210,000 of revenue from these activities).
We have not generated any revenue to date from our vaccine or therapeutics programs. In addition, while we pursue our vaccine and therapeutics
programs, we may also make investments in and form new companies to develop additional emerging technologies. We do not expect to begin
generating revenue with respect to any of our current vaccine or therapy programs in the near term. We hope to achieve a profitable outcome
by eventually licensing our technologies to large pharmaceutical companies that have the resources and infrastructure in place to manufacture,
market and sell our technologies as vaccines or therapeutics. The eventual licensing of any of our technologies may take several years,
if it is to occur at all, and may depend on positive results from human clinical trials.
Funding
and Management’s Plans
Based
on currently available information as of September 6, 2023, we believe that our existing cash, cash equivalents, short-term investments
and expected cash flows will be sufficient to fund our activities for at least the next twelve months. We have implemented a business
model that conserves funds by collaborating with third parties to develop our technologies. However, our projections of future cash needs
and cash flows may differ from actual results. If current cash on hand, cash equivalents, short-term investments and cash that may be
generated from our business operations are insufficient to continue to operate our business, or if we elect to invest in or acquire a
company or companies or new technology or technologies that are synergistic with or complementary to our technologies, we may be required
to obtain more working capital. Under our at-the-market equity program as of July 31, 2023, we may sell up to $100 million of common
stock. We did not sell any shares under our at-the-market equity program during the three and nine months ended July 31, 2023. We may
seek to obtain working capital during our fiscal year 2023 or thereafter through sales of our equity securities or public or private
debt from various financial institutions where possible. We cannot be certain that additional funding will be available on acceptable
terms, or at all. If we do identify sources for additional funding, the sale of additional equity securities or convertible debt will
result in dilution to our stockholders. We can give no assurance that we will generate sufficient cash flows in the future to satisfy
our liquidity requirements or sustain future operations, or that other sources of funding, such as sales of equity or debt, would be
available or would be approved by our security holders, if needed, on favorable terms or at all. If we fail to obtain additional working
capital as and when needed, such failure could have a material adverse impact on our business, results of operations and financial condition.
Furthermore, such lack of funds may inhibit our ability to respond to competitive pressures or unanticipated capital needs, or may force
us to reduce operating expenses, which would significantly harm the business and development of operations.
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v3.23.2
SIGNIFICANT ACCOUNTING POLICIES
|
9 Months Ended |
Jul. 31, 2023 |
Accounting Policies [Abstract] |
|
SIGNIFICANT ACCOUNTING POLICIES |
2.
SIGNIFICANT ACCOUNTING POLICIES
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 fiscal year ended October 31, 2022. The accompanying October 31, 2022 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, 2023, and results of operations and cash flows for the interim periods represented. The results of operations
for the three and nine months ended July 31, 2023 are not necessarily indicative of the results to be expected for the year.
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, 2023 (in thousands):
SCHEDULE OF CHANGES IN NONCONTROLLING INTEREST
Balance, October 31, 2022 | |
$ | (847 | ) |
Net loss attributable to noncontrolling interest | |
| (88 | ) |
Balance, July 31, 2023 | |
$ | (935 | ) |
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.
Our
revenue recognition policy requires us 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, within 30 days of execution of the agreement, of contractually determined, one-time, paid-up
license fees in settlement of litigation and in consideration for the grant of certain intellectual property rights for patented technologies
owned or controlled by the Company. These arrangements typically include some combination of the following: (i) the grant of a non-exclusive,
retroactive and future license to manufacture and/or sell products covered by patented technologies owned or controlled by the Company,
(ii) a covenant-not-to-sue, (iii) the release of the licensee from certain claims, and (iv) the dismissal of any pending litigation.
In such instances, the intellectual property rights granted have been perpetual in nature, extending until the expiration of the related
patents. Pursuant to the terms of these agreements, we have no further obligations with respect to the granted intellectual property
rights, including no obligation to maintain or upgrade the technology, or provide future support or services. Licensees obtained control
of the intellectual property rights they have acquired upon execution of the agreement. Accordingly, the performance obligations from
these agreements were satisfied and 100% of the revenue was recognized upon the execution of the agreements.
Cost
of Revenues
Cost
of revenues include the costs and expenses incurred in connection with our patent licensing and enforcement activities, including inventor
royalties paid to original patent owners, contingent legal fees paid to external counsel, other patent-related legal expenses paid to
external counsel and licensing and enforcement related research, consulting and other expenses paid to third-parties. These costs are
included under the caption “Operating costs and expenses” in the accompanying condensed consolidated statements of operations.
Research
and Development Expenses
Research
and development expenses, consisting primarily of employee compensation, payments to third parties for research and development activities
and other direct costs associated with developing immuno-therapy drugs against cancer, developing anti-viral drug candidates for COVID-19
(through March 2023), developing our breast cancer vaccine, and developing our ovarian cancer vaccine, are expensed in the consolidated
financial statements in the period incurred.
Investment
Policy
The
Company’s investment policy is to acquire debt securities with fixed maturities and contractual cash flows that the Company has
the positive intent and ability to hold to maturity. These securities are recorded at amortized cost, net of any applicable discount
which is amortized to interest income, and are accounted for as held-to-maturity securities.
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- DefinitionThe entire disclosure for all significant accounting policies of the reporting entity.
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v3.23.2
SHARE-BASED COMPENSATION
|
9 Months Ended |
Jul. 31, 2023 |
Share-Based Payment Arrangement [Abstract] |
|
SHARE-BASED COMPENSATION |
3.
SHARE-BASED COMPENSATION
The
Company maintains 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 share-based compensation expense related to service-based
stock options granted to employees and directors of approximately $1,153,000 and $941,000 during the three months ended July 31, 2023
and 2022, respectively, and approximately $3,265,000 and $2,546,000 during the nine months ended July 31, 2023 and 2022, 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 June 1, 2021, our Chairman and Chief Executive Officer and
our President, Chief Operating Officer and Chief Financial Officer were awarded market condition stock options for 2,000,000 shares and
100,000 shares of common stock, respectively, that vest in four equal installments upon the Company’s share price achieving targets
ranging from $5.00 to $8.00 per share, with implied service periods of three to fifteen months. We recorded market condition stock-based
compensation expense during the three months ended July 31, 2023 and 2022 of approximately $0 and $388,000, respectively, and approximately
$0 and $2,381,000 during the nine months ended July 31, 2023 and 2022, respectively.
The
compensation cost for service-based stock options granted to consultants is measured at the grant date, based on the fair value of the
award using the Black-Scholes pricing model, and is expensed on a straight-line basis over the requisite service period (the vesting
period of the stock option) which is one to three years. We recorded stock-based consulting expense related to stock options granted
to consultants of approximately $47,000 and $109,000 during the three months ended July 31, 2023 and 2022, respectively, and approximately
$175,000 and $326,000 during the nine months ended July 31, 2023 and 2022, respectively.
For
stock options granted to consultants that vest based on market conditions, such as changes in trading activity in the Company’s
common stock, we use the Black-Scholes pricing model to estimate the fair value at the time which we believe the market conditions are
reasonably likely to be met. On January 30, 2023, we granted market condition stock options to a consultant for 200,000 shares of common
stock, that vests in full upon the achievement of certain Company stock trading activity metrics that must be met within twelve months.
We did not record any market condition stock-based compensation expense on the date of grant nor in the three and nine months ended July
31, 2023, as we do not believe it is likely that the market conditions will be met.
Stock
Option Plans
During
the three months ended July 31, 2023, we had securities outstanding that were granted from two stock option plans: the Anixa Biosciences,
Inc. 2010 Share Incentive Plan (the “2010 Share Plan”) and the Anixa Biosciences, Inc. 2018 Share Incentive Plan (the “2018
Share Plan”), which were adopted by our Board of Directors on July 14, 2010 and January 25, 2018, respectively. The 2018 Share
Plan was approved by our shareholders on March 29, 2018.
Stock
Option Activity
During
the three months ended July 31, 2023 and 2022, we did not grant any options to purchase shares of common stock, and during the nine months
ended July 31, 2023 and 2022, we granted options to purchase 1,505,000 shares and 1,430,000 shares of common stock, respectively, to
employees and consultants, with exercise prices ranging from $4.19 to $4.81 per share, pursuant to the 2018 Share Plan. During the three
months ended July 31, 2023 and 2022, stock options to purchase 10,446 and 321,388 shares of common stock, respectively, were exercised
on a cash basis, with aggregate proceeds of approximately $3,000 and $830,000, respectively. During the three months ended July 31, 2023
and 2022, stock options to purchase 160,000 shares of common stock, of which 115,417 shares were withheld, and 680,000 shares of common
stock, of which 505,340 shares were withheld, were exercised on a cashless basis, respectively. During the nine months ended July 31,
2023 and 2022, stock options to purchase 39,525 and 321,388 shares of common stock, respectively, were exercised on a cash basis, with
aggregate proceeds of approximately $81,000 and $830,000, respectively. During the nine months ended July 31, 2023 and 2022, stock options
to purchase 161,111 shares of common stock, of which 116,225 shares were withheld, and 780,000 shares of common stock, of which 558,431
shares were withheld, were exercised on a cashless basis, respectively.
2010
Share Plan
The
2010 Share Plan provided for the grant of nonqualified stock options, stock appreciation rights, stock awards, performance awards and
stock units to employees, directors and consultants. In accordance with the provisions of the 2010 Share Plan, the plan terminated with
respect to the ability to grant future awards on July 14, 2020. Information regarding the 2010 Share Plan for the nine months ended July
31, 2023 is as follows:
SCHEDULE OF OPTION ACTIVITY
| |
Shares | | |
Weighted
Average Exercise Price Per Share | | |
Aggregate
Intrinsic Value
(in thousands) | |
Options outstanding at October 31, 2022 | |
| 1,501,500 | | |
$ | 2.83 | | |
| | |
Exercised | |
| (194,264 | ) | |
$ | 2.46 | | |
| | |
Options outstanding and exercisable at July 31, 2023 | |
| 1,307,236 | | |
$ | 2.89 | | |
$ | 1,252 | |
The
following table summarizes information about stock options outstanding and exercisable under the 2010 Share Plan as of July 31, 2023:
SCHEDULE OF OUTSTANDING AND EXERCISABLE
Range of Exercise Prices | |
Number Outstanding and Exercisable | | |
Weighted Average Remaining Contractual Life (in years) | | |
Weighted Average Exercise Price | |
$0.67 - $2.27 | |
| 462,500 | | |
| 3.1 | | |
$ | 1.48 | |
$2.58 - $3.13 | |
| 335,736 | | |
| 2.3 | | |
$ | 2.89 | |
$3.46 - $5.30 | |
| 509,000 | | |
| 4.8 | | |
$ | 4.17 | |
2018
Share Plan
The
2018 Share Plan provides for the grant of incentive stock options, nonqualified stock options, stock appreciation rights, stock awards,
performance awards and stock units to employees, directors and consultants. As of July 31, 2023, the 2018 Share Plan had 825,000 shares
available for future grants. Information regarding the 2018 Share Plan for the nine months ended July 31, 2023 is as follows:
SCHEDULE OF OPTION ACTIVITY
| |
Shares | | |
Weighted Average Exercise Price Per Share | | |
Aggregate Intrinsic Value (in thousands) | |
Options outstanding at October 31, 2022 | |
| 8,817,372 | | |
$ | 3.57 | | |
| | |
Granted | |
| 1,505,000 | | |
$ | 4.29 | | |
| | |
Exercised | |
| (6,372 | ) | |
$ | 2.89 | | |
| | |
Expirations | |
| (150,000 | ) | |
$ | 5.30 | | |
| | |
Options outstanding at July 31, 2023 | |
| 10,166,000 | | |
$ | 3.68 | | |
$ | 2,308 | |
Options exercisable at July 31, 2023 | |
| 6,366,137 | | |
$ | 3.51 | | |
$ | 1,699 | |
The
following table summarizes information about stock options outstanding and exercisable under the 2018 Share Plan as of July 31, 2023:
SCHEDULE OF OUTSTANDING AND EXERCISABLE
| |
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 | |
$ 2.09 - $3.87 | |
| 5,341,000 | | |
| 6.7 | | |
$ | 3.24 | | |
| 4,618,778 | | |
| 6.4 | | |
$ | 3.31 | |
$ 3.96 - $5.30 | |
| 4,825,000 | | |
| 7.9 | | |
$ | 4.16 | | |
| 1,747,359 | | |
| 7.1 | | |
$ | 4.03 | |
Employee
Stock Purchase Plan
The
Company maintains the Anixa Biosciences, Inc. Employee Stock Purchase Plan (the “ESPP”) 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, 2023 and 2022, employees purchased 1,903 and 2,389 shares,
respectively, with aggregate proceeds of approximately $6,000 and $6,000, respectively.
Warrants
On
October 30, 2020, we issued a warrant, expiring on October 30, 2025, to purchase 60,000 shares of common stock at $2.06 per share, vesting
over five months, to a consultant for investor relations services. On November 16, 2021, the warrant was exercised on a cashless basis
and 25,484 shares were withheld as payment.
On
November 1, 2021, we issued a warrant, expiring on October 30, 2026, to purchase 60,000 shares of common stock at $4.77 per share, vesting
over five months, to a consultant for investor relations services. We recorded consulting expense of approximately $0 and $220,000, respectively,
during the three and nine months ended July 31, 2022, based on the fair value of the warrant on the date of grant recognized on a straight-line
basis over the vesting period. The warrant terminated in May 2022 upon termination of the consulting agreement.
As
of July 31, 2023, we also had warrants outstanding to purchase 300,000 shares of common stock at $6.56 per share, issued during fiscal
year 2021 and expiring on March 22, 2026.
Information
regarding the Company’s warrants for the nine months ended July 31, 2023 is as follows:
SCHEDULE OF WARRANTS ACTIVITY
| |
Shares | | |
Weighted Average Exercise Price Per Share | | |
Aggregate Intrinsic Value | |
Warrants outstanding at October 31, 2022 | |
| 300,000 | | |
$ | 6.56 | | |
| | |
Warrants outstanding and exercisable at July 31, 2023 | |
| 300,000 | | |
$ | 6.56 | | |
$ | 0 | |
The
following table summarizes information about the Company’s outstanding and exercisable warrants as of July 31, 2023:
SCHEDULE OF OUTSTANDING AND EXERCISABLE
Range of Exercise
Prices | | |
Number Outstanding and Exercisable | | |
Weighted Average Remaining Contractual Life (in
years) | | |
Weighted Average Exercise
Price | |
$ | 6.56 | | |
| 300,000 | | |
| 2.6 | | |
$ | 6.56 | |
|
X |
- DefinitionTabular disclosure of share-based payment arrangement.
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v3.23.2
FAIR VALUE MEASUREMENTS
|
9 Months Ended |
Jul. 31, 2023 |
Fair Value Disclosures [Abstract] |
|
FAIR VALUE MEASUREMENTS |
4.
FAIR VALUE MEASUREMENTS
US
GAAP defines fair value and establishes a framework for measuring fair value. We have categorized our financial assets and liabilities,
based on the priority of the inputs to the valuation technique, into a three-level fair value hierarchy as set forth below. If the inputs
used to measure the financial instruments fall within different levels of the hierarchy, the categorization is based on the lowest level
input that is significant to the fair value measurement of the instrument.
Financial
assets and liabilities recorded in the accompanying condensed consolidated balance sheets are categorized based on the inputs to the
valuation techniques as follows:
Level
1 – Financial instruments 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 instruments 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 instruments 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 instruments.
The
following table presents the hierarchy for our financial assets measured at fair value on a recurring basis as of July 31, 2023 (in thousands):
SCHEDULE OF FAIR VALUE MEASUREMENTS
| |
Level 1 | | |
Level 2 | | |
Level 3 | | |
Total | |
Money market funds: | |
| | | |
| | | |
| | | |
| | |
Cash equivalents | |
$ | 1,070 | | |
$ | - | | |
$ | - | | |
$ | 1,070 | |
Certificates of deposit: | |
| | | |
| | | |
| | | |
| | |
Cash equivalents | |
| - | | |
| 1,981 | | |
| - | | |
| 1,981 | |
Short-term investments | |
| - | | |
| 6,850 | | |
| - | | |
| 6,850 | |
U.S. treasury bills: | |
| | | |
| | | |
| | | |
| | |
Short-term investments | |
| - | | |
| 15,486 | | |
| - | | |
| 15,486 | |
Total financial assets | |
$ | 1,070 | | |
$ | 24,317 | | |
$ | - | | |
$ | 25,387 | |
The
following table presents the hierarchy for our financial assets measured at fair value on a recurring basis as of October 31, 2022 (in
thousands):
| |
Level 1 | | |
Level 2 | | |
Level 3 | | |
Total | |
Money market funds: | |
| | | |
| | | |
| | | |
| | |
Cash equivalents | |
$ | 11,175 | | |
$ | - | | |
$ | - | | |
$ | 11,175 | |
Certificates of deposit: | |
| | | |
| | | |
| | | |
| | |
Cash equivalents | |
| - | | |
| 1,000 | | |
| - | | |
| 1,000 | |
Short term investments | |
| - | | |
| 13,700 | | |
| - | | |
| 13,700 | |
U.S. treasury bills | |
| | | |
| | | |
| - | | |
| | |
Short-term investments | |
| - | | |
| 3,627 | | |
| - | | |
| 3,627 | |
Total financial assets | |
$ | 11,175 | | |
$ | 18,327 | | |
$ | - | | |
$ | 29,502 | |
Our
non-financial assets that are measured at fair value on a non-recurring basis are property and equipment and other assets which are measured
using fair value techniques whenever events or changes in circumstances indicate a condition of impairment exists. The estimated fair
value of prepaid expenses and other current assets, accounts payable and accrued expenses approximates their individual carrying amounts
due to the short-term nature of these measurements. The carrying value of cash equivalents approximates fair value.
|
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- DefinitionThe entire disclosure for the fair value of financial instruments (as defined), including financial assets and financial liabilities (collectively, as defined), and the measurements of those instruments as well as disclosures related to the fair value of non-financial assets and liabilities. Such disclosures about the financial instruments, assets, and liabilities would include: (1) the fair value of the required items together with their carrying amounts (as appropriate); (2) for items for which it is not practicable to estimate fair value, disclosure would include: (a) information pertinent to estimating fair value (including, carrying amount, effective interest rate, and maturity, and (b) the reasons why it is not practicable to estimate fair value; (3) significant concentrations of credit risk including: (a) information about the activity, region, or economic characteristics identifying a concentration, (b) the maximum amount of loss the entity is exposed to based on the gross fair value of the related item, (c) policy for requiring collateral or other security and information as to accessing such collateral or security, and (d) the nature and brief description of such collateral or security; (4) quantitative information about market risks and how such risks are managed; (5) for items measured on both a recurring and nonrecurring basis information regarding the inputs used to develop the fair value measurement; and (6) for items presented in the financial statement for which fair value measurement is elected: (a) information necessary to understand the reasons for the election, (b) discussion of the effect of fair value changes on earnings, (c) a description of [similar groups] items for which the election is made and the relation thereof to the balance sheet, the aggregate carrying value of items included in the balance sheet that are not eligible for the election; (7) all other required (as defined) and desired information.
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v3.23.2
ACCRUED EXPENSES
|
9 Months Ended |
Jul. 31, 2023 |
Payables and Accruals [Abstract] |
|
ACCRUED EXPENSES |
5.
ACCRUED EXPENSES
Accrued
expenses consist of the following as of:
SCHEDULE OF ACCRUED EXPENSES
| |
July 31, 2023 | | |
October 31, 2022 | |
| |
(in thousands) | |
Payroll and related expenses | |
$ | 977 | | |
$ | 492 | |
Accrued royalty and contingent legal fees | |
| 626 | | |
| 577 | |
Accrued collaborative research expenses | |
| 99 | | |
| - | |
Accrued other | |
| 10 | | |
| 26 | |
Accrued
expenses | |
$ | 1,712 | | |
$ | 1,095 | |
|
X |
- DefinitionThe entire disclosure for accounts payable and accrued liabilities at the end of the reporting period.
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v3.23.2
NET LOSS PER SHARE OF COMMON STOCK
|
9 Months Ended |
Jul. 31, 2023 |
Net loss per common share attributable to common shareholders: |
|
NET LOSS PER SHARE OF COMMON STOCK |
6.
NET LOSS PER SHARE OF COMMON STOCK
Basic
net loss per common share (“Basic EPS”) is computed by dividing net loss by the weighted average number of common shares
outstanding. Diluted net loss per common share (“Diluted EPS”) is computed by dividing net loss by the weighted average number
of common shares and dilutive common share equivalents and convertible securities then outstanding. Diluted EPS for all periods presented
is the same as Basic EPS, as the inclusion of the effect of common share equivalents then outstanding would be anti-dilutive. For this
reason, excluded from the calculation of Diluted EPS for the nine months ended July 31, 2023 and 2022, were stock options to purchase
11,473,236 and 11,094,104 shares, respectively, and warrants to purchase 300,000 and 300,000 shares, respectively.
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- DefinitionThe entire disclosure for earnings per share.
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v3.23.2
EFFECT OF RECENTLY ADOPTED AND ISSUED PRONOUNCEMENTS
|
9 Months Ended |
Jul. 31, 2023 |
Effect Of Recently Adopted And Issued Pronouncements |
|
EFFECT OF RECENTLY ADOPTED AND ISSUED PRONOUNCEMENTS |
7.
EFFECT OF RECENTLY ADOPTED AND ISSUED PRONOUNCEMENTS
In
August 2020, the FASB issued Accounting Standards Update 2020-06 (“ASU 2020-06”), Accounting for Convertible Instruments
and Contracts in an Entity’s Own Equity. The amendments in ASU 2020-06 include guidance on convertible instruments and the derivative
scope exception for contracts in an entity’s own equity and simplifies the accounting for convertible instruments which include
beneficial conversion features or cash conversion features by removing certain separation models in Subtopic 470-20. Additionally, ASU
2020-06 will require entities to use the “if-converted” method when calculating diluted earnings per share for convertible
instruments. The amendments in this update are effective for fiscal years beginning after December 15, 2021, including interim periods
within those fiscal years. The adoption of this standard did not have a material impact on our consolidated financial statements and
related disclosures.
In
May 2021, the FASB issued Accounting Standards Update 2021-04 (“ASU 2021-04”), Issuer’s Accounting for Certain Modifications
or Exchanges of Freestanding Equity-Classified Written Call Options. The guidance in ASU 2021-04 requires the issuer to treat a modification
of an equity-classified written call option (the “option”) that does not cause the option to become liability-classified
as an exchange of the original option for a new option. This guidance applies whether the modification is structured as an amendment
to the terms and conditions of the option or as termination of the original option and issuance of a new option. The amendments in this
update are effective for fiscal years beginning after December 15, 2021, including interim periods within those fiscal years. The adoption
of this standard did not have a material impact on our consolidated financial statements and related disclosures.
In
October 2021, the FASB issued Accounting Standards Update 2021-08, Business Combinations (Topic 805): Accounting for Contract Assets
and Contract Liabilities from Contracts with Customers, to require that an acquirer recognize and measure contract assets and contract
liabilities acquired in a business combination in accordance with Topic 606, Revenue from Contracts with Customers. At the acquisition
date, an acquirer should account for the related revenue contracts in accordance with Topic 606 as if it had originated the contracts.
The amendments in this update should be applied prospectively and are effective for fiscal years beginning after December 15, 2022, including
interim periods within those fiscal years. We do not expect the adoption of this standard to have a material impact on our consolidated
financial statements and related disclosures.
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v3.23.2
INCOME TAXES
|
9 Months Ended |
Jul. 31, 2023 |
Income Tax Disclosure [Abstract] |
|
INCOME TAXES |
8. INCOME
TAXES
We
recognize deferred tax assets and liabilities for the estimated future tax effects of events that have been recognized in our financial
statements or tax returns. Under this method, deferred tax assets and liabilities are determined based on the difference between the
financial statement and tax bases of assets and liabilities using enacted tax rates in effect in the years in which the differences are
expected to reverse. A valuation allowance is established, when necessary, to reduce deferred tax assets to the amount expected to be
realized. We have provided a full valuation allowance against our deferred tax asset due to our historical pre-tax losses and the uncertainty
regarding the realizability of these deferred tax assets.
We
have substantial net operating loss carryforwards for Federal and California income tax returns. These net operating loss carryforwards
could be subject to limitations under Internal Revenue Code section 382, the effects of which have not been determined by the Company.
We have no unrecognized income tax benefits as of July 31, 2023 and October 31, 2022 and we account for interest and penalties related
to income tax matters, if any, in general and administrative expenses.
|
X |
- DefinitionThe entire disclosure for income taxes. Disclosures may include net deferred tax liability or asset recognized in an enterprise's statement of financial position, net change during the year in the total valuation allowance, approximate tax effect of each type of temporary difference and carryforward that gives rise to a significant portion of deferred tax liabilities and deferred tax assets, utilization of a tax carryback, and tax uncertainties information.
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v3.23.2
LEASES
|
9 Months Ended |
Jul. 31, 2023 |
Leases |
|
LEASES |
9. 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 was to expire on September 30, 2021. Effective August 17, 2021, the lease
was amended to extend the expiration date to September 30, 2024, with an option to extend the lease an additional two years. 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. The amendment to the lease resulted in a right-of-use asset and lease liability of approximately $260,000
with a discount rate of 10%. Rent expense was approximately $17,000 and $17,000, respectively, for the three months ended July 31, 2023
and 2022, and approximately $50,000 and $50,000, respectively, for the nine months ended July 31, 2023 and 2022.
For
operating leases, the lease liability is initially measured at the present value of the unpaid lease payments. The remaining 38-month
lease term as of July 31, 2023 for the Company’s lease includes the noncancelable period of the lease and the additional two-year
option period that the Company expects to exercise. All right-of-use assets are reviewed for impairment when indications of impairment
are present.
As
of July 31, 2023, the annual minimum future lease payments of our operating lease liabilities were as follows (in thousands):
SCHEDULE OF MINIMUM LEASE PAYMENTS
For Periods Ended October 31, | |
Operating Leases | |
2023 | |
$ | 17 | |
2024 | |
| 67 | |
2025 | |
| 70 | |
2026 | |
| 65 | |
Total future minimum lease payments, undiscounted | |
| 219 | |
Less: Imputed interest | |
| 32 | |
Present value of future minimum lease payments | |
$ | 187 | |
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v3.23.2
COMMITMENTS AND CONTINGENCES
|
9 Months Ended |
Jul. 31, 2023 |
Commitments and Contingencies Disclosure [Abstract] |
|
COMMITMENTS AND CONTINGENCES |
10. COMMITMENTS
AND CONTINGENCES
Litigation
Matters
Other
than lawsuits related to the enforcement of our patent rights, we are not a party to any material pending legal proceedings, nor are
we 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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- DefinitionThe entire disclosure for commitments and contingencies.
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v3.23.2
SEGMENT INFORMATION
|
9 Months Ended |
Jul. 31, 2023 |
Segment Reporting [Abstract] |
|
SEGMENT INFORMATION |
11.
SEGMENT INFORMATION
We
follow the accounting guidance of ASC 280 “Segment Reporting” (“ASC 280”). Reportable operating segments are
determined based on the management approach. The management approach, as defined by ASC 280, is based on the way that the chief operating
decision-maker organizes the segments within an enterprise for making operating decisions and assessing performance. While our results
of operations are primarily reviewed on a consolidated basis, the chief operating decision-maker manages the enterprise in four reportable
segments, each with different operating and potential revenue generating characteristics: (i) CAR-T Therapeutics, (ii) Cancer Vaccines,
(iii) Anti-Viral Therapeutics and (iv) Other. The following represents selected financial information for our segments for the three
and nine months ended July 31, 2023 and 2022 and as of July 31, 2023 and October 31, 2022, in thousands:
SCHEDULE OF SEGMENT INFORMATION
| |
2023 | | |
2022 | | |
2023 | | |
2022 | |
| |
For the Three Months Ended
July 31, | | |
For the Nine Months Ended
July 31, | |
| |
2023 | | |
2022 | | |
2023 | | |
2022 | |
Net Loss: | |
| | | |
| | | |
| | | |
| | |
CAR-T Therapeutics | |
$ | (1,091 | ) | |
$ | (965 | ) | |
$ | (2,999 | ) | |
$ | (3,975 | ) |
Cancer Vaccines | |
| (1,390 | ) | |
| (903 | ) | |
| (3,261 | ) | |
| (3,684 | ) |
Anti-Viral Therapeutics | |
| (62 | ) | |
| (904 | ) | |
| (960 | ) | |
| (2,565 | ) |
Other | |
| (5 | ) | |
| (3 | ) | |
| 11 | | |
| (18 | ) |
Total | |
$ | (2,548 | ) | |
$ | (2,775 | ) | |
$ | (7,209 | ) | |
$ | (10,242 | ) |
| |
| | | |
| | | |
| | | |
| | |
Total operating costs and expenses | |
$ | 2,844 | | |
$ | 2,797 | | |
$ | 8,170 | | |
$ | 10,266 | |
Less non-cash share-based compensation | |
| (1,217 | ) | |
| (1,446 | ) | |
| (3,507 | ) | |
| (5,546 | ) |
Operating costs and expenses excluding non-cash share-based compensation | |
$ | 1,627 | | |
$ | 1,351 | | |
$ | 4,663 | | |
$ | 4,720 | |
Operating costs and expenses excluding non-cash share-based compensation: | |
| | | |
| | | |
| | | |
| | |
CAR-T Therapeutics | |
$ | 713 | | |
$ | 421 | | |
$ | 1,930 | | |
$ | 1,823 | |
Cancer Vaccines | |
| 855 | | |
| 376 | | |
| 1,966 | | |
| 1,571 | |
Anti-Viral Therapeutics | |
| 55 | | |
| 552 | | |
| 572 | | |
| 1,312 | |
Other | |
| 4 | | |
| 2 | | |
| 195 | | |
| 14 | |
Total | |
$ | 1,627 | | |
$ | 1,351 | | |
$ | 4,663 | | |
$ | 4,720 | |
| |
July 31, 2023 | | |
October 31, 2022 | |
Total assets: | |
| | | |
| | |
CAR-T Therapeutics | |
$ | 11,640 | | |
$ | 16,921 | |
Cancer Vaccines | |
| 13,968 | | |
| 9,442 | |
Anti-Viral Therapeutics | |
| 898 | | |
| 3,811 | |
Other | |
| 72 | | |
| 238 | |
Total | |
$ | 26,578 | | |
$ | 30,412 | |
Operating
costs and expenses excluding non-cash share-based compensation is the measurement the chief operating decision-maker uses in managing
the enterprise.
The
Company’s consolidated revenue of $210,000 and inventor royalties, contingent legal fees, litigation and licensing expense of $161,000
for the nine months ended July 31, 2023 were solely related to our encrypted audio/video conference calling technology, which is included
in our Other segment. All our revenue is generated domestically (United States) based on the country in which the licensee is located.
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v3.23.2
SIGNIFICANT ACCOUNTING POLICIES (Policies)
|
9 Months Ended |
Jul. 31, 2023 |
Accounting Policies [Abstract] |
|
Basis of Presentation |
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 fiscal year ended October 31, 2022. The accompanying October 31, 2022 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, 2023, and results of operations and cash flows for the interim periods represented. The results of operations
for the three and nine months ended July 31, 2023 are not necessarily indicative of the results to be expected for the year.
|
Noncontrolling Interest |
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, 2023 (in thousands):
SCHEDULE OF CHANGES IN NONCONTROLLING INTEREST
Balance, October 31, 2022 | |
$ | (847 | ) |
Net loss attributable to noncontrolling interest | |
| (88 | ) |
Balance, July 31, 2023 | |
$ | (935 | ) |
|
Revenue Recognition |
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.
Our
revenue recognition policy requires us 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, within 30 days of execution of the agreement, of contractually determined, one-time, paid-up
license fees in settlement of litigation and in consideration for the grant of certain intellectual property rights for patented technologies
owned or controlled by the Company. These arrangements typically include some combination of the following: (i) the grant of a non-exclusive,
retroactive and future license to manufacture and/or sell products covered by patented technologies owned or controlled by the Company,
(ii) a covenant-not-to-sue, (iii) the release of the licensee from certain claims, and (iv) the dismissal of any pending litigation.
In such instances, the intellectual property rights granted have been perpetual in nature, extending until the expiration of the related
patents. Pursuant to the terms of these agreements, we have no further obligations with respect to the granted intellectual property
rights, including no obligation to maintain or upgrade the technology, or provide future support or services. Licensees obtained control
of the intellectual property rights they have acquired upon execution of the agreement. Accordingly, the performance obligations from
these agreements were satisfied and 100% of the revenue was recognized upon the execution of the agreements.
|
Cost of Revenues |
Cost
of Revenues
Cost
of revenues include the costs and expenses incurred in connection with our patent licensing and enforcement activities, including inventor
royalties paid to original patent owners, contingent legal fees paid to external counsel, other patent-related legal expenses paid to
external counsel and licensing and enforcement related research, consulting and other expenses paid to third-parties. These costs are
included under the caption “Operating costs and expenses” in the accompanying condensed consolidated statements of operations.
|
Research and Development Expenses |
Research
and Development Expenses
Research
and development expenses, consisting primarily of employee compensation, payments to third parties for research and development activities
and other direct costs associated with developing immuno-therapy drugs against cancer, developing anti-viral drug candidates for COVID-19
(through March 2023), developing our breast cancer vaccine, and developing our ovarian cancer vaccine, are expensed in the consolidated
financial statements in the period incurred.
|
Investment Policy |
Investment
Policy
The
Company’s investment policy is to acquire debt securities with fixed maturities and contractual cash flows that the Company has
the positive intent and ability to hold to maturity. These securities are recorded at amortized cost, net of any applicable discount
which is amortized to interest income, and are accounted for as held-to-maturity securities.
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v3.23.2
SIGNIFICANT ACCOUNTING POLICIES (Tables)
|
9 Months Ended |
Jul. 31, 2023 |
Accounting Policies [Abstract] |
|
SCHEDULE OF CHANGES IN 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, 2023 (in thousands):
SCHEDULE OF CHANGES IN NONCONTROLLING INTEREST
Balance, October 31, 2022 | |
$ | (847 | ) |
Net loss attributable to noncontrolling interest | |
| (88 | ) |
Balance, July 31, 2023 | |
$ | (935 | ) |
|
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v3.23.2
SHARE-BASED COMPENSATION (Tables)
|
9 Months Ended |
Jul. 31, 2023 |
Share-Based Compensation Arrangement by Share-Based Payment Award [Line Items] |
|
SCHEDULE OF WARRANTS ACTIVITY |
Information
regarding the Company’s warrants for the nine months ended July 31, 2023 is as follows:
SCHEDULE OF WARRANTS ACTIVITY
| |
Shares | | |
Weighted Average Exercise Price Per Share | | |
Aggregate Intrinsic Value | |
Warrants outstanding at October 31, 2022 | |
| 300,000 | | |
$ | 6.56 | | |
| | |
Warrants outstanding and exercisable at July 31, 2023 | |
| 300,000 | | |
$ | 6.56 | | |
$ | 0 | |
|
Warrant [Member] |
|
Share-Based Compensation Arrangement by Share-Based Payment Award [Line Items] |
|
SCHEDULE OF OUTSTANDING AND EXERCISABLE |
The
following table summarizes information about the Company’s outstanding and exercisable warrants as of July 31, 2023:
SCHEDULE OF OUTSTANDING AND EXERCISABLE
Range of Exercise
Prices | | |
Number Outstanding and Exercisable | | |
Weighted Average Remaining Contractual Life (in
years) | | |
Weighted Average Exercise
Price | |
$ | 6.56 | | |
| 300,000 | | |
| 2.6 | | |
$ | 6.56 | |
|
2010 Share Plan [Member] |
|
Share-Based Compensation Arrangement by Share-Based Payment Award [Line Items] |
|
SCHEDULE OF OPTION ACTIVITY |
SCHEDULE OF OPTION ACTIVITY
| |
Shares | | |
Weighted
Average Exercise Price Per Share | | |
Aggregate
Intrinsic Value
(in thousands) | |
Options outstanding at October 31, 2022 | |
| 1,501,500 | | |
$ | 2.83 | | |
| | |
Exercised | |
| (194,264 | ) | |
$ | 2.46 | | |
| | |
Options outstanding and exercisable at July 31, 2023 | |
| 1,307,236 | | |
$ | 2.89 | | |
$ | 1,252 | |
|
SCHEDULE OF OUTSTANDING AND EXERCISABLE |
The
following table summarizes information about stock options outstanding and exercisable under the 2010 Share Plan as of July 31, 2023:
SCHEDULE OF OUTSTANDING AND EXERCISABLE
Range of Exercise Prices | |
Number Outstanding and Exercisable | | |
Weighted Average Remaining Contractual Life (in years) | | |
Weighted Average Exercise Price | |
$0.67 - $2.27 | |
| 462,500 | | |
| 3.1 | | |
$ | 1.48 | |
$2.58 - $3.13 | |
| 335,736 | | |
| 2.3 | | |
$ | 2.89 | |
$3.46 - $5.30 | |
| 509,000 | | |
| 4.8 | | |
$ | 4.17 | |
|
2018 Share Plan [Member] |
|
Share-Based Compensation Arrangement by Share-Based Payment Award [Line Items] |
|
SCHEDULE OF OPTION ACTIVITY |
SCHEDULE OF OPTION ACTIVITY
| |
Shares | | |
Weighted Average Exercise Price Per Share | | |
Aggregate Intrinsic Value (in thousands) | |
Options outstanding at October 31, 2022 | |
| 8,817,372 | | |
$ | 3.57 | | |
| | |
Granted | |
| 1,505,000 | | |
$ | 4.29 | | |
| | |
Exercised | |
| (6,372 | ) | |
$ | 2.89 | | |
| | |
Expirations | |
| (150,000 | ) | |
$ | 5.30 | | |
| | |
Options outstanding at July 31, 2023 | |
| 10,166,000 | | |
$ | 3.68 | | |
$ | 2,308 | |
Options exercisable at July 31, 2023 | |
| 6,366,137 | | |
$ | 3.51 | | |
$ | 1,699 | |
|
SCHEDULE OF OUTSTANDING AND EXERCISABLE |
The
following table summarizes information about stock options outstanding and exercisable under the 2018 Share Plan as of July 31, 2023:
SCHEDULE OF OUTSTANDING AND EXERCISABLE
| |
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 | |
$ 2.09 - $3.87 | |
| 5,341,000 | | |
| 6.7 | | |
$ | 3.24 | | |
| 4,618,778 | | |
| 6.4 | | |
$ | 3.31 | |
$ 3.96 - $5.30 | |
| 4,825,000 | | |
| 7.9 | | |
$ | 4.16 | | |
| 1,747,359 | | |
| 7.1 | | |
$ | 4.03 | |
|
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v3.23.2
FAIR VALUE MEASUREMENTS (Tables)
|
9 Months Ended |
Jul. 31, 2023 |
Fair Value Disclosures [Abstract] |
|
SCHEDULE OF FAIR VALUE MEASUREMENTS |
The
following table presents the hierarchy for our financial assets measured at fair value on a recurring basis as of July 31, 2023 (in thousands):
SCHEDULE OF FAIR VALUE MEASUREMENTS
| |
Level 1 | | |
Level 2 | | |
Level 3 | | |
Total | |
Money market funds: | |
| | | |
| | | |
| | | |
| | |
Cash equivalents | |
$ | 1,070 | | |
$ | - | | |
$ | - | | |
$ | 1,070 | |
Certificates of deposit: | |
| | | |
| | | |
| | | |
| | |
Cash equivalents | |
| - | | |
| 1,981 | | |
| - | | |
| 1,981 | |
Short-term investments | |
| - | | |
| 6,850 | | |
| - | | |
| 6,850 | |
U.S. treasury bills: | |
| | | |
| | | |
| | | |
| | |
Short-term investments | |
| - | | |
| 15,486 | | |
| - | | |
| 15,486 | |
Total financial assets | |
$ | 1,070 | | |
$ | 24,317 | | |
$ | - | | |
$ | 25,387 | |
The
following table presents the hierarchy for our financial assets measured at fair value on a recurring basis as of October 31, 2022 (in
thousands):
| |
Level 1 | | |
Level 2 | | |
Level 3 | | |
Total | |
Money market funds: | |
| | | |
| | | |
| | | |
| | |
Cash equivalents | |
$ | 11,175 | | |
$ | - | | |
$ | - | | |
$ | 11,175 | |
Certificates of deposit: | |
| | | |
| | | |
| | | |
| | |
Cash equivalents | |
| - | | |
| 1,000 | | |
| - | | |
| 1,000 | |
Short term investments | |
| - | | |
| 13,700 | | |
| - | | |
| 13,700 | |
U.S. treasury bills | |
| | | |
| | | |
| - | | |
| | |
Short-term investments | |
| - | | |
| 3,627 | | |
| - | | |
| 3,627 | |
Total financial assets | |
$ | 11,175 | | |
$ | 18,327 | | |
$ | - | | |
$ | 29,502 | |
|
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v3.23.2
ACCRUED EXPENSES (Tables)
|
9 Months Ended |
Jul. 31, 2023 |
Payables and Accruals [Abstract] |
|
SCHEDULE OF ACCRUED EXPENSES |
Accrued
expenses consist of the following as of:
SCHEDULE OF ACCRUED EXPENSES
| |
July 31, 2023 | | |
October 31, 2022 | |
| |
(in thousands) | |
Payroll and related expenses | |
$ | 977 | | |
$ | 492 | |
Accrued royalty and contingent legal fees | |
| 626 | | |
| 577 | |
Accrued collaborative research expenses | |
| 99 | | |
| - | |
Accrued other | |
| 10 | | |
| 26 | |
Accrued
expenses | |
$ | 1,712 | | |
$ | 1,095 | |
|
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v3.23.2
LEASES (Tables)
|
9 Months Ended |
Jul. 31, 2023 |
Leases |
|
SCHEDULE OF MINIMUM LEASE PAYMENTS |
As
of July 31, 2023, the annual minimum future lease payments of our operating lease liabilities were as follows (in thousands):
SCHEDULE OF MINIMUM LEASE PAYMENTS
For Periods Ended October 31, | |
Operating Leases | |
2023 | |
$ | 17 | |
2024 | |
| 67 | |
2025 | |
| 70 | |
2026 | |
| 65 | |
Total future minimum lease payments, undiscounted | |
| 219 | |
Less: Imputed interest | |
| 32 | |
Present value of future minimum lease payments | |
$ | 187 | |
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v3.23.2
SEGMENT INFORMATION (Tables)
|
9 Months Ended |
Jul. 31, 2023 |
Segment Reporting [Abstract] |
|
SCHEDULE OF SEGMENT INFORMATION |
SCHEDULE OF SEGMENT INFORMATION
| |
2023 | | |
2022 | | |
2023 | | |
2022 | |
| |
For the Three Months Ended
July 31, | | |
For the Nine Months Ended
July 31, | |
| |
2023 | | |
2022 | | |
2023 | | |
2022 | |
Net Loss: | |
| | | |
| | | |
| | | |
| | |
CAR-T Therapeutics | |
$ | (1,091 | ) | |
$ | (965 | ) | |
$ | (2,999 | ) | |
$ | (3,975 | ) |
Cancer Vaccines | |
| (1,390 | ) | |
| (903 | ) | |
| (3,261 | ) | |
| (3,684 | ) |
Anti-Viral Therapeutics | |
| (62 | ) | |
| (904 | ) | |
| (960 | ) | |
| (2,565 | ) |
Other | |
| (5 | ) | |
| (3 | ) | |
| 11 | | |
| (18 | ) |
Total | |
$ | (2,548 | ) | |
$ | (2,775 | ) | |
$ | (7,209 | ) | |
$ | (10,242 | ) |
| |
| | | |
| | | |
| | | |
| | |
Total operating costs and expenses | |
$ | 2,844 | | |
$ | 2,797 | | |
$ | 8,170 | | |
$ | 10,266 | |
Less non-cash share-based compensation | |
| (1,217 | ) | |
| (1,446 | ) | |
| (3,507 | ) | |
| (5,546 | ) |
Operating costs and expenses excluding non-cash share-based compensation | |
$ | 1,627 | | |
$ | 1,351 | | |
$ | 4,663 | | |
$ | 4,720 | |
Operating costs and expenses excluding non-cash share-based compensation: | |
| | | |
| | | |
| | | |
| | |
CAR-T Therapeutics | |
$ | 713 | | |
$ | 421 | | |
$ | 1,930 | | |
$ | 1,823 | |
Cancer Vaccines | |
| 855 | | |
| 376 | | |
| 1,966 | | |
| 1,571 | |
Anti-Viral Therapeutics | |
| 55 | | |
| 552 | | |
| 572 | | |
| 1,312 | |
Other | |
| 4 | | |
| 2 | | |
| 195 | | |
| 14 | |
Total | |
$ | 1,627 | | |
$ | 1,351 | | |
$ | 4,663 | | |
$ | 4,720 | |
| |
July 31, 2023 | | |
October 31, 2022 | |
Total assets: | |
| | | |
| | |
CAR-T Therapeutics | |
$ | 11,640 | | |
$ | 16,921 | |
Cancer Vaccines | |
| 13,968 | | |
| 9,442 | |
Anti-Viral Therapeutics | |
| 898 | | |
| 3,811 | |
Other | |
| 72 | | |
| 238 | |
Total | |
$ | 26,578 | | |
$ | 30,412 | |
|
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v3.23.2
SCHEDULE OF OPTION ACTIVITY (Details) $ / shares in Units, $ in Thousands |
9 Months Ended |
Jul. 31, 2023
USD ($)
$ / shares
shares
|
2010 Share Plan [Member] |
|
Share-Based Compensation Arrangement by Share-Based Payment Award [Line Items] |
|
Shares, options outstanding, beginning balance | shares |
1,501,500
|
Weighted Average Exercise Price Per Share, Outstanding Beginning balance | $ / shares |
$ 2.83
|
Shares, options, exercised | shares |
(194,264)
|
Weighted average exercise price per share, exercised | $ / shares |
$ 2.46
|
Shares, Options outstanding, Ending balance | shares |
1,307,236
|
Weighted Average Exercise Price Per Share, Outstanding Ending balance | $ / shares |
$ 2.89
|
Aggregate intrinsic value, outstanding and exercisable | $ |
$ 1,252
|
2018 Share Plan [Member] |
|
Share-Based Compensation Arrangement by Share-Based Payment Award [Line Items] |
|
Shares, options outstanding, beginning balance | shares |
8,817,372
|
Weighted Average Exercise Price Per Share, Outstanding Beginning balance | $ / shares |
$ 3.57
|
Shares, options, exercised | shares |
(6,372)
|
Weighted average exercise price per share, exercised | $ / shares |
$ 2.89
|
Shares, Options outstanding, Ending balance | shares |
10,166,000
|
Weighted Average Exercise Price Per Share, Outstanding Ending balance | $ / shares |
$ 3.68
|
Shares, options, granted | shares |
1,505,000
|
Weighted Average Exercise Price Per Share, Granted | $ / shares |
$ 4.29
|
Shares, options, exercised | shares |
(150,000)
|
Weighted average exercise price per share, exercised | $ / shares |
$ 5.30
|
Aggregate Intrinsic Value, Outstanding Ending balance | $ |
$ 2,308
|
Shares, Options outstanding, Exercisable | shares |
6,366,137
|
Weighted Average Exercise Price Per Share, Exercisable | $ / shares |
$ 3.51
|
Aggregate Intrinsic Value, Exercisable | $ |
$ 1,699
|
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v3.23.2
SCHEDULE OF OUTSTANDING AND EXERCISABLE (Details) - $ / shares
|
9 Months Ended |
|
Jul. 31, 2023 |
Oct. 31, 2022 |
Range One [Member] | Warrant [Member] |
|
|
Share-Based Compensation Arrangement by Share-Based Payment Award [Line Items] |
|
|
Number outstanding and exercisable |
300,000
|
|
Weighted average remaining contractual life |
2 years 7 months 6 days
|
|
Weighted average exercise price |
$ 6.56
|
|
Range of exercise prices |
$ 6.56
|
|
2010 Share Plan [Member] |
|
|
Share-Based Compensation Arrangement by Share-Based Payment Award [Line Items] |
|
|
Number outstanding and exercisable |
1,307,236
|
1,501,500
|
Weighted average exercise price |
$ 2.89
|
$ 2.83
|
2010 Share Plan [Member] | Range One [Member] |
|
|
Share-Based Compensation Arrangement by Share-Based Payment Award [Line Items] |
|
|
Range of exercise prices, lower limit |
0.67
|
|
Range of exercise prices, upper limit |
$ 2.27
|
|
Number outstanding and exercisable |
462,500
|
|
Weighted average remaining contractual life |
3 years 1 month 6 days
|
|
Weighted average exercise price |
$ 1.48
|
|
2010 Share Plan [Member] | Range Two [Member] |
|
|
Share-Based Compensation Arrangement by Share-Based Payment Award [Line Items] |
|
|
Range of exercise prices, lower limit |
2.58
|
|
Range of exercise prices, upper limit |
$ 3.13
|
|
Number outstanding and exercisable |
335,736
|
|
Weighted average remaining contractual life |
2 years 3 months 18 days
|
|
Weighted average exercise price |
$ 2.89
|
|
2010 Share Plan [Member] | Range Three [Member] |
|
|
Share-Based Compensation Arrangement by Share-Based Payment Award [Line Items] |
|
|
Range of exercise prices, lower limit |
3.46
|
|
Range of exercise prices, upper limit |
$ 5.30
|
|
Number outstanding and exercisable |
509,000
|
|
Weighted average remaining contractual life |
4 years 9 months 18 days
|
|
Weighted average exercise price |
$ 4.17
|
|
2018 Share Plan [Member] |
|
|
Share-Based Compensation Arrangement by Share-Based Payment Award [Line Items] |
|
|
Number outstanding and exercisable |
10,166,000
|
8,817,372
|
Weighted average exercise price |
$ 3.68
|
$ 3.57
|
Number exercisable, options exercisable |
6,366,137
|
|
Weighted average exercise price, options exercisable |
$ 3.51
|
|
2018 Share Plan [Member] | Range One [Member] |
|
|
Share-Based Compensation Arrangement by Share-Based Payment Award [Line Items] |
|
|
Range of exercise prices, lower limit |
2.09
|
|
Range of exercise prices, upper limit |
$ 3.87
|
|
Number outstanding and exercisable |
5,341,000
|
|
Weighted average remaining contractual life |
6 years 8 months 12 days
|
|
Weighted average exercise price |
$ 3.24
|
|
Number exercisable, options exercisable |
4,618,778
|
|
Weighted average remaining contractual life (in years), options exercisable |
6 years 4 months 24 days
|
|
Weighted average exercise price, options exercisable |
$ 3.31
|
|
2018 Share Plan [Member] | Range Two [Member] |
|
|
Share-Based Compensation Arrangement by Share-Based Payment Award [Line Items] |
|
|
Range of exercise prices, lower limit |
3.96
|
|
Range of exercise prices, upper limit |
$ 5.30
|
|
Number outstanding and exercisable |
4,825,000
|
|
Weighted average remaining contractual life |
7 years 10 months 24 days
|
|
Weighted average exercise price |
$ 4.16
|
|
Number exercisable, options exercisable |
1,747,359
|
|
Weighted average remaining contractual life (in years), options exercisable |
7 years 1 month 6 days
|
|
Weighted average exercise price, options exercisable |
$ 4.03
|
|
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v3.23.2
SCHEDULE OF WARRANTS ACTIVITY (Details) $ / shares in Units, $ in Thousands |
Jul. 31, 2023
USD ($)
$ / shares
shares
|
Weighted average exercise price per share warrants outstanding, beginning balance | $ / shares |
$ 6.56
|
Weighted average exercise price per share warrants outstanding and exercisable, ending balance | $ / shares |
$ 6.56
|
Aggregate intrinsic value, Warrants outstanding and exercisable, ending balance | $ |
$ 0
|
Warrant [Member] |
|
Warrants outstanding, beginning balance | shares |
300,000
|
Warrants outstanding and exercisable, ending balance | shares |
300,000
|
X |
- DefinitionNumber of equity instruments other than options exercisable, including both vested and non-vested instruments.
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v3.23.2
SHARE-BASED COMPENSATION (Details Narrative) - USD ($)
|
|
|
|
|
|
3 Months Ended |
9 Months Ended |
Jan. 30, 2023 |
Nov. 16, 2021 |
Nov. 01, 2021 |
Jun. 01, 2021 |
Oct. 30, 2020 |
Jul. 31, 2023 |
Jul. 31, 2022 |
Jul. 31, 2023 |
Jul. 31, 2022 |
Share-Based Compensation Arrangement by Share-Based Payment Award [Line Items] |
|
|
|
|
|
|
|
|
|
Stock option exercised |
|
|
|
|
|
$ 3,000
|
$ 830,000
|
$ 81,000
|
$ 830,000
|
Common stock issued pursuant to employee stock purchase plan, value |
|
|
|
|
|
|
|
6,000
|
6,000
|
Common Stock [Member] |
|
|
|
|
|
|
|
|
|
Share-Based Compensation Arrangement by Share-Based Payment Award [Line Items] |
|
|
|
|
|
|
|
|
|
Stock option exercised |
|
|
|
|
|
|
$ 5,000
|
$ 1,000
|
$ 6,000
|
Option to purchase common stock |
|
|
|
|
|
55,029
|
496,048
|
84,411
|
577,473
|
Common stock issued pursuant to employee stock purchase plan, shares |
|
|
|
|
|
|
|
1,903
|
2,389
|
Common stock issued pursuant to employee stock purchase plan, value |
|
|
|
|
|
|
|
|
|
Warrant [Member] |
|
|
|
|
|
|
|
|
|
Share-Based Compensation Arrangement by Share-Based Payment Award [Line Items] |
|
|
|
|
|
|
|
|
|
Warrant expiration date |
|
|
Oct. 30, 2026
|
|
Oct. 30, 2025
|
|
|
|
|
Warrant exercise price |
|
|
|
|
|
$ 6.56
|
|
$ 6.56
|
|
Vesting period |
|
|
5 months
|
|
|
|
|
|
|
Consulting expense |
|
|
|
|
|
|
$ 0
|
|
$ 220,000
|
Warrants to purchase common stock |
|
|
|
|
|
300,000
|
|
300,000
|
|
Warrants maturity date |
|
|
|
|
|
Mar. 22, 2026
|
|
Mar. 22, 2026
|
|
2018 Share Plan [Member] |
|
|
|
|
|
|
|
|
|
Share-Based Compensation Arrangement by Share-Based Payment Award [Line Items] |
|
|
|
|
|
|
|
|
|
Shares options, granted |
|
|
|
|
|
|
|
1,505,000
|
|
Exercise price |
|
|
|
|
|
|
|
$ 2.89
|
|
Option to purchase common stock |
|
|
|
|
|
|
|
6,372
|
|
Shares available for future grants |
|
|
|
|
|
825,000
|
|
825,000
|
|
Employee Stock Purchase Plan [Member] |
|
|
|
|
|
|
|
|
|
Share-Based Compensation Arrangement by Share-Based Payment Award [Line Items] |
|
|
|
|
|
|
|
|
|
Purchase price of common stock percentage |
|
|
|
|
|
|
|
85.00%
|
|
Common stock issued pursuant to employee stock purchase plan, shares |
|
|
|
|
|
|
|
1,903
|
2,389
|
Common stock issued pursuant to employee stock purchase plan, value |
|
|
|
|
|
|
|
$ 6,000
|
$ 6,000
|
Equity Option [Member] | 2018 Share Plan [Member] |
|
|
|
|
|
|
|
|
|
Share-Based Compensation Arrangement by Share-Based Payment Award [Line Items] |
|
|
|
|
|
|
|
|
|
Shares options, granted |
|
|
|
2,000,000
|
|
|
|
|
|
Equity Option [Member] | 2018 Share Plan [Member] | Minimum [Member] |
|
|
|
|
|
|
|
|
|
Share-Based Compensation Arrangement by Share-Based Payment Award [Line Items] |
|
|
|
|
|
|
|
|
|
Exercise price |
|
|
|
$ 5.00
|
|
|
|
|
|
Equity Option [Member] | 2018 Share Plan [Member] | Maximum [Member] |
|
|
|
|
|
|
|
|
|
Share-Based Compensation Arrangement by Share-Based Payment Award [Line Items] |
|
|
|
|
|
|
|
|
|
Exercise price |
|
|
|
$ 8.00
|
|
|
|
|
|
Equity Option [Member] | 2018 Share Plan [Member] | Common Stock [Member] |
|
|
|
|
|
|
|
|
|
Share-Based Compensation Arrangement by Share-Based Payment Award [Line Items] |
|
|
|
|
|
|
|
|
|
Shares options, granted |
|
|
|
100,000
|
|
|
|
|
|
Non Vested Stock Option [Member] |
|
|
|
|
|
|
|
|
|
Share-Based Compensation Arrangement by Share-Based Payment Award [Line Items] |
|
|
|
|
|
|
|
|
|
Stock-based compensation |
|
|
|
|
|
$ 0
|
$ 388,000
|
$ 0
|
$ 2,381,000
|
Stock Option Activity [Member] |
|
|
|
|
|
|
|
|
|
Share-Based Compensation Arrangement by Share-Based Payment Award [Line Items] |
|
|
|
|
|
|
|
|
|
Shares options, granted |
200,000
|
|
|
|
|
|
|
|
|
Option to purchase common stock |
|
|
|
|
|
10,446
|
321,388
|
39,525
|
321,388
|
Stock option exercised |
|
|
|
|
|
$ 3,000
|
$ 830,000
|
$ 81,000
|
$ 830,000
|
Option to purchase common stock |
|
|
|
|
|
160,000
|
680,000
|
161,111
|
780,000
|
Option to purchase common stock withheld |
|
|
|
|
|
115,417
|
505,340
|
116,225
|
558,431
|
Employees and Directors [Member] |
|
|
|
|
|
|
|
|
|
Share-Based Compensation Arrangement by Share-Based Payment Award [Line Items] |
|
|
|
|
|
|
|
|
|
Stock-based compensation |
|
|
|
|
|
$ 1,153,000
|
$ 941,000
|
$ 3,265,000
|
$ 2,546,000
|
Consultants [Member] |
|
|
|
|
|
|
|
|
|
Share-Based Compensation Arrangement by Share-Based Payment Award [Line Items] |
|
|
|
|
|
|
|
|
|
Options granted |
|
|
|
|
|
$ 47,000
|
$ 109,000
|
$ 175,000
|
$ 326,000
|
Consultants [Member] | Warrant [Member] |
|
|
|
|
|
|
|
|
|
Share-Based Compensation Arrangement by Share-Based Payment Award [Line Items] |
|
|
|
|
|
|
|
|
|
Warrants purchase of common stock |
|
|
60,000
|
|
60,000
|
|
|
|
|
Warrant exercise price |
|
|
$ 4.77
|
|
$ 2.06
|
|
|
|
|
Number of shares as payment |
|
25,484
|
|
|
|
|
|
|
|
Employees and Consultants [Member] | 2018 Share Plan [Member] |
|
|
|
|
|
|
|
|
|
Share-Based Compensation Arrangement by Share-Based Payment Award [Line Items] |
|
|
|
|
|
|
|
|
|
Shares options, granted |
|
|
|
|
|
|
|
1,505,000
|
1,430,000
|
Employees and Consultants [Member] | 2018 Share Plan [Member] | Minimum [Member] |
|
|
|
|
|
|
|
|
|
Share-Based Compensation Arrangement by Share-Based Payment Award [Line Items] |
|
|
|
|
|
|
|
|
|
Share exercise price |
|
|
|
|
|
$ 4.19
|
|
$ 4.19
|
|
Employees and Consultants [Member] | 2018 Share Plan [Member] | Maximum [Member] |
|
|
|
|
|
|
|
|
|
Share-Based Compensation Arrangement by Share-Based Payment Award [Line Items] |
|
|
|
|
|
|
|
|
|
Share exercise price |
|
|
|
|
|
$ 4.81
|
|
$ 4.81
|
|
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v3.23.2
SCHEDULE OF FAIR VALUE MEASUREMENTS (Details) - USD ($) $ in Thousands |
Jul. 31, 2023 |
Oct. 31, 2022 |
Fair Value, Assets and Liabilities Measured on Recurring and Nonrecurring Basis [Line Items] |
|
|
Total financial assets |
$ 25,387
|
$ 29,502
|
Money Market Funds [Member] |
|
|
Fair Value, Assets and Liabilities Measured on Recurring and Nonrecurring Basis [Line Items] |
|
|
Cash equivalents |
1,070
|
11,175
|
Certificates of Deposit [Member] |
|
|
Fair Value, Assets and Liabilities Measured on Recurring and Nonrecurring Basis [Line Items] |
|
|
Cash equivalents |
1,981
|
1,000
|
Short-term investments |
6,850
|
13,700
|
US Treasury Securities [Member] |
|
|
Fair Value, Assets and Liabilities Measured on Recurring and Nonrecurring Basis [Line Items] |
|
|
Short-term investments |
15,486
|
3,627
|
Fair Value, Inputs, Level 1 [Member] |
|
|
Fair Value, Assets and Liabilities Measured on Recurring and Nonrecurring Basis [Line Items] |
|
|
Total financial assets |
1,070
|
11,175
|
Fair Value, Inputs, Level 1 [Member] | Money Market Funds [Member] |
|
|
Fair Value, Assets and Liabilities Measured on Recurring and Nonrecurring Basis [Line Items] |
|
|
Cash equivalents |
1,070
|
11,175
|
Fair Value, Inputs, Level 1 [Member] | Certificates of Deposit [Member] |
|
|
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|
|
Cash equivalents |
|
|
Short-term investments |
|
|
Fair Value, Inputs, Level 1 [Member] | US Treasury Securities [Member] |
|
|
Fair Value, Assets and Liabilities Measured on Recurring and Nonrecurring Basis [Line Items] |
|
|
Short-term investments |
|
|
Fair Value, Inputs, Level 2 [Member] |
|
|
Fair Value, Assets and Liabilities Measured on Recurring and Nonrecurring Basis [Line Items] |
|
|
Total financial assets |
24,317
|
18,327
|
Fair Value, Inputs, Level 2 [Member] | Money Market Funds [Member] |
|
|
Fair Value, Assets and Liabilities Measured on Recurring and Nonrecurring Basis [Line Items] |
|
|
Cash equivalents |
|
|
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|
|
Fair Value, Assets and Liabilities Measured on Recurring and Nonrecurring Basis [Line Items] |
|
|
Cash equivalents |
1,981
|
1,000
|
Short-term investments |
6,850
|
13,700
|
Fair Value, Inputs, Level 2 [Member] | US Treasury Securities [Member] |
|
|
Fair Value, Assets and Liabilities Measured on Recurring and Nonrecurring Basis [Line Items] |
|
|
Short-term investments |
15,486
|
3,627
|
Fair Value, Inputs, Level 3 [Member] |
|
|
Fair Value, Assets and Liabilities Measured on Recurring and Nonrecurring Basis [Line Items] |
|
|
Total financial assets |
|
|
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|
|
Fair Value, Assets and Liabilities Measured on Recurring and Nonrecurring Basis [Line Items] |
|
|
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|
|
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|
|
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|
|
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|
|
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|
|
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|
|
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|
|
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|
|
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v3.23.2
LEASES (Details Narrative)
|
3 Months Ended |
9 Months Ended |
Jul. 31, 2023
USD ($)
ft²
|
Jul. 31, 2022
USD ($)
|
Jul. 31, 2023
USD ($)
ft²
|
Jul. 31, 2022
USD ($)
|
Payments for rent |
$ 17,000
|
$ 17,000
|
$ 50,000
|
$ 50,000
|
Almaden Expressway San Jose [Member] |
|
|
|
|
Area of land | ft² |
2,000
|
|
2,000
|
|
Lease expiration date |
|
|
Sep. 30, 2021
|
|
Lease extension |
|
|
Effective August 17, 2021, the lease
was amended to extend the expiration date to September 30, 2024, with an option to extend the lease an additional two years
|
|
Payments for rent |
|
|
$ 5,000
|
|
Rent percentage |
|
|
3.00%
|
|
Right of use asset obtained in exchange for operating lease liability |
|
|
$ 260,000
|
|
Operating lease weighted average discount rate percent |
10.00%
|
|
10.00%
|
|
Lessee operating lease term of contract |
38 months
|
|
38 months
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v3.23.2
SCHEDULE OF SEGMENT INFORMATION (Details) - USD ($) $ in Thousands |
3 Months Ended |
9 Months Ended |
|
Jul. 31, 2023 |
Jul. 31, 2022 |
Jul. 31, 2023 |
Jul. 31, 2022 |
Oct. 31, 2022 |
Segment Reporting Information [Line Items] |
|
|
|
|
|
Total |
$ (2,548)
|
$ (2,775)
|
$ (7,209)
|
$ (10,242)
|
|
Total operating costs and expenses |
2,844
|
2,797
|
8,170
|
10,266
|
|
Less non-cash share-based compensation |
(1,217)
|
(1,446)
|
(3,507)
|
(5,546)
|
|
Total |
1,627
|
1,351
|
4,663
|
4,720
|
|
Total |
26,578
|
|
26,578
|
|
$ 30,412
|
Cart Therapeutics [Member] |
|
|
|
|
|
Segment Reporting Information [Line Items] |
|
|
|
|
|
Total |
(1,091)
|
(965)
|
(2,999)
|
(3,975)
|
|
Total |
713
|
421
|
1,930
|
1,823
|
|
Total |
11,640
|
|
11,640
|
|
16,921
|
Cancer Vaccines [Member] |
|
|
|
|
|
Segment Reporting Information [Line Items] |
|
|
|
|
|
Total |
(1,390)
|
(903)
|
(3,261)
|
(3,684)
|
|
Total |
855
|
376
|
1,966
|
1,571
|
|
Total |
13,968
|
|
13,968
|
|
9,442
|
Anti Viral Therapeutics [Member] |
|
|
|
|
|
Segment Reporting Information [Line Items] |
|
|
|
|
|
Total |
(62)
|
(904)
|
(960)
|
(2,565)
|
|
Total |
55
|
552
|
572
|
1,312
|
|
Total |
898
|
|
898
|
|
3,811
|
Other [Member] |
|
|
|
|
|
Segment Reporting Information [Line Items] |
|
|
|
|
|
Total |
(5)
|
(3)
|
11
|
(18)
|
|
Total |
4
|
$ 2
|
195
|
$ 14
|
|
Total |
$ 72
|
|
$ 72
|
|
$ 238
|
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