2 unchanged sentences
AND SUBSIDIARIES
−Removed: CONSOLIDATED BALANCE SHEETS
+Added: CONSOLIDATED BALANCE SHEETS (UNAUDITED)
thousands, except share and per share data)
−Removed: Current assets:
−Removed: Cash and cash
−Removed: Short-term investments
+Added: and cash equivalents
expenses and other current assets
−Removed: Total current assets
−Removed: Operating lease right-of-use
−Removed: LIABILITIES AND EQUITY
−Removed: Current liabilities:
−Removed: Accounts payable
−Removed: Accrued expenses
+Added: current assets
+Added: lease right-of-use asset
lease liability
current liabilities
−Removed: Operating lease liability,
−Removed: Commitments and contingencies (Note 9)
−Removed: Shareholders’ equity:
−Removed: Preferred stock, par value
−Removed: $ 100 per share;
−Removed: 19,860 shares authorized;
−Removed: no shares issued or outstanding
−Removed: Series A convertible preferred
+Added: lease liability, non-current
+Added: and contingencies (Note 10)
+Added: Shareholders’
stock, par value $ 100 per share;
19,860 shares authorized;
+Added: shares issued or outstanding
+Added: A convertible preferred stock, par value $ 100 per share;
+Added: 140 shares authorized;
no shares issued or outstanding
−Removed: Preferred stock
−Removed: Common stock, par value
−Removed: $ .01 per share;
+Added: stock, par value $ .01 per share;
100,000,000 shares authorized;
−Removed: 30,653,418 and 30,050,894 shares issued and outstanding as of July 31, 2022 and October
−Removed: 31, 2021, respectively
−Removed: Additional paid-in capital
−Removed: Total shareholders’
+Added: 30,922,830 and 30,913,902 shares issued and outstanding as of January
+Added: 31, 2023 and October 31, 2022, respectively
+Added: paid-in capital
+Added: shareholders’ equity
Noncontrolling
6 unchanged sentences
thousands, except per share data)
−Removed: For the three months ended
−Removed: For the nine months ended
−Removed: Operating costs and expenses:
−Removed: Inventor royalties,
−Removed: contingent legal fees, litigation and licensing expenses
−Removed: Research and development
−Removed: expenses (including non-cash share-based compensation expenses of $ 771 , $ 1,688 , $ 3,014 and $ 2,425 , respectively)
+Added: the Three Months Ended
+Added: costs and expenses:
+Added: and development expenses (including non-cash share-based compensation expenses of $ 505 and $ 1,276 , respectively)
and administrative expenses (including non-cash share-based compensation expenses of $ 558 and $ 1,078 , respectively)
operating costs and expenses
−Removed: Loss from operations
−Removed: Interest income
−Removed: Net loss attributable
−Removed: to noncontrolling interest
−Removed: Net loss attributable
−Removed: to common shareholders
−Removed: Net loss per common share attributable to common
−Removed: shareholders:
−Removed: Weighted average common shares outstanding:
+Added: from operations
+Added: Net loss attributable to noncontrolling interest
+Added: loss attributable to common shareholders
+Added: loss per common share attributable to common shareholders:
+Added: Weighted average
+Added: common shares outstanding:
accompanying notes are an integral part of these condensed consolidated financial statements.
1 unchanged sentence
AND SUBSIDIARIES
−Removed: CONSOLIDATED STATEMENTS OF SHAREHOLDERS’ EQUITY (UNAUDITED )
+Added: CONSOLIDATED STATEMENTS OF SHAREHOLDERS’ EQUITY
thousands, except share data)
−Removed: THE THREE MONTHS ENDED JULY 31, 2022
−Removed: Shareholders’
−Removed: Balance, April 30, 2022
−Removed: $ ( 212,163 )
−Removed: Stock option compensation to employees and
−Removed: Stock options issued to consultants
−Removed: Common stock issued upon exercise of stock
−Removed: Common stock issued to consultants
−Removed: Balance, July 31, 2022
−Removed: $ ( 214,909 )
−Removed: THE THREE MONTHS ENDED JULY 31, 2021
+Added: THE THREE MONTHS ENDED JANUARY 31, 2023 (UNAUDITED )
Shareholders’
−Removed: Balance, April 30, 2021
−Removed: $ ( 196,443 )
−Removed: Stock option compensation to employees and
−Removed: Expired restricted stock award to employee
+Added: October 31, 2022
$ ( 218,385 )
−Removed: Stock options issued to consultants
−Removed: Balance, July 31, 2021
+Added: option compensation to employees and
+Added: options and warrants issued to consultants
+Added: stock issued to consultants
+Added: stock issued upon exercise of stock
+Added: January 31, 2023
$ ( 220,707 )
−Removed: accompanying notes are an integral part of these condensed consolidated financial statements.
−Removed: BIOSCIENCES, INC.
−Removed: AND SUBSIDIARIES
−Removed: CONSOLIDATED STATEMENTS OF SHAREHOLDERS’ EQUITY (UNAUDITED )
−Removed: thousands, except share data)
−Removed: THE NINE MONTHS ENDED JULY 31, 2022
+Added: THE THREE MONTHS ENDED JANUARY 31, 2022 (UNAUDITED )
Shareholders’
−Removed: Balance, October 31, 2021
−Removed: $ ( 204,790 )
−Removed: Stock option compensation to employees and
−Removed: Stock options and warrants issued to consultants
−Removed: Common stock issued upon exercise of stock
−Removed: Common stock issued to consultants
−Removed: Common stock issued pursuant to employee stock
−Removed: purchase plan
−Removed: Balance, July 31, 2022
+Added: October 31, 2021
$ ( 204,790 )
−Removed: THE NINE MONTHS ENDED JULY 31, 2021
−Removed: Balance, October 31, 2020
$ ( 204,790 )
−Removed: Stock option compensation to employees and
−Removed: Expired restricted stock award to employee
+Added: option compensation to employees and
+Added: options and warrants issued to consultants
+Added: stock issued upon exercise of stock
+Added: options and warrants
+Added: January 31, 2022
$ ( 208,619 )
−Removed: Stock options and warrants issued to consultants
−Removed: Common stock issued upon exercise of stock
−Removed: Common stock issued pursuant to employee stock
−Removed: purchase plan
−Removed: Common stock issued in a public offering,
−Removed: offering expenses of $ 2,208
−Removed: Common stock issued in at-the-market offering,
−Removed: net of offering expenses of $ 341
−Removed: Balance, July, 2021
+Added: Balance, value
$ ( 208,619 )
3 unchanged sentences
CONSOLIDATED STATEMENTS OF CASH FLOWS (UNAUDITED)
−Removed: the nine months ended July 31,
−Removed: Cash flows from operating activities:
−Removed: Reconciliation of net loss
−Removed: to net cash used in operating activities:
−Removed: Stock option compensation
−Removed: to employees and directors
−Removed: Stock options and warrants
−Removed: issued to consultants
−Removed: Common stock issued to
−Removed: Gain on sale of equipment
−Removed: Amortization of operating
−Removed: lease right-of-use asset
−Removed: Change in operating assets
−Removed: and liabilities:
−Removed: Prepaid expenses and other
−Removed: current assets
−Removed: Accounts payable
−Removed: Accrued expenses
+Added: the three months ended
+Added: flows from operating activities:
+Added: Reconciliation
+Added: of net loss to net cash used in operating activities:
+Added: option compensation to employees and directors
+Added: options and warrants issued to consultants
+Added: stock issued to consultants
+Added: of operating lease right-to-use asset
+Added: in operating assets and liabilities:
+Added: expenses and other current assets
lease liability
cash used in operating activities
−Removed: Cash flows from investing activities:
−Removed: Disbursements to acquire
−Removed: short-term investments
−Removed: Proceeds from maturities
−Removed: of short-term investments
−Removed: from sale of equipment
−Removed: cash used in investing activities
−Removed: Cash flows from financing activities:
−Removed: Gross proceeds from sale
−Removed: of common stock in a public offering
−Removed: Expenses of the public
−Removed: Gross proceeds from sale
−Removed: of common stock in an at-the-market offering
−Removed: Expenses of the at-the-market
−Removed: Proceeds from sale of
−Removed: common stock pursuant to employee stock purchase plan
+Added: flows from investing activities:
+Added: Disbursements
+Added: to acquire short-term investments
+Added: from maturities of short-term investments
+Added: cash provided by (used in) investing activities
+Added: flows from financing activities:
from exercise of stock options
cash provided by financing activities
−Removed: Net (decrease) increase in cash and cash equivalents
−Removed: Cash and cash equivalents
−Removed: at beginning of period
−Removed: Cash and cash equivalents
−Removed: at end of period
+Added: increase (decrease) in cash and cash equivalents
+Added: and cash equivalents at beginning of period
+Added: and cash equivalents at end of period
accompanying notes are an integral part of these condensed consolidated financial statements.
2 unchanged sentences
TO CONDENSED CONSOLIDATED FINANCIAL STATEMENTS
−Removed: BUSINESS AND FUNDING
used herein, “we,” “us,” “our,” the “Company” or “Anixa” means Anixa Biosciences,
2 unchanged sentences
unmet needs in oncology and infectious disease.
−Removed: Our therapeutics programs include (i) the development of a chimeric endocrine receptor
−Removed: T-cell therapy, a novel form of chimeric antigen receptor T-cell (“CAR-T”) technology, initially focused on treating ovarian
−Removed: cancer, which is being developed by our subsidiary, Certainty Therapeutics, Inc.
−Removed: (“Certainty”), and (ii) the discovery and
−Removed: ultimately development of anti-viral drug candidates for the treatment of COVID-19 focused on inhibiting certain protein functions of
−Removed: Our vaccine programs include (i) the development of a preventative vaccine against triple negative breast cancer (“TNBC”),
−Removed: the most lethal form of breast cancer, as well other forms of breast cancer and (ii) a preventative vaccine against ovarian cancer.
−Removed: subsidiary, Certainty, is developing immuno-therapy drugs against cancer.
−Removed: Certainty holds an exclusive worldwide, royalty-bearing license
−Removed: to use certain intellectual property owned or controlled by The Wistar Institute (“Wistar”), the nation’s first independent
−Removed: biomedical research institute and a leading National Cancer Institute designated cancer research center, relating to Wistar’s chimeric
−Removed: endocrine receptor targeted therapy technology.
−Removed: We have initially focused on the development of a treatment for ovarian cancer, but we
−Removed: also may pursue applications of the technology for the development of treatments for additional solid tumors.
−Removed: The license agreement requires
−Removed: Certainty to make certain cash and equity payments to Wistar upon achievement of specific development milestones.
−Removed: With respect to Certainty’s
−Removed: equity obligations to Wistar, Certainty issued to Wistar shares of its common stock equal to five percent ( 5 %) of the common stock of
−Removed: in collaboration with the H.
−Removed: Lee Moffitt Cancer Center and Research Institute, Inc.
−Removed: (“Moffitt”), is advancing toward human
−Removed: clinical testing of the CAR-T technology licensed by Certainty from Wistar aimed initially at treating ovarian cancer.
−Removed: We received authorization
−Removed: from the U.S.
−Removed: Food and Drug Administration (“FDA”) in August 2021, to commence enrollment and treatment of patients in a
−Removed: Phase 1 clinical trial.
−Removed: We began patient recruitment for the trial in March 2022, and in August 2022, we treated the first patient in
−Removed: The treatment appears to have been well-tolerated by the patient, and we continue to monitor her condition.
−Removed: The process of
−Removed: recruiting additional patients is ongoing.
−Removed: This study is a dose-escalation trial with two arms based on injection method—intraperitoneal
−Removed: or intravenous—to determine the maximum tolerated dose in patients with recurrent epithelial ovarian cancer and to assess persistence,
−Removed: expansion and efficacy of the modified T-cells.
−Removed: The study is being conducted at Moffitt and will consist of 24 to 48 patients who have
−Removed: received at least two prior lines of chemotherapy.
−Removed: The study is estimated to be completed in two to four years depending on multiple
−Removed: factors including when maximum tolerated dose is reached and the rate of patient recruitment.
−Removed: April 2020, we entered into a collaboration with OntoChem GmbH (“OntoChem”) to discover and ultimately develop anti-viral
−Removed: drug candidates against COVID-19.
−Removed: Through this collaboration, we utilized advanced computational methods, machine learning, and molecular
−Removed: modeling techniques to perform in silico screening of over 1.2 billion compounds in chemical libraries (including publicly available
−Removed: compounds and OntoChem’s proprietary libraries) to evaluate if any of these compounds could disrupt one of two key enzymes of SARS-CoV-2,
−Removed: the virus that causes the disease COVID-19.
−Removed: screening process resulted in the identification of multiple compounds that could potentially disrupt critical enzymes of the virus,
−Removed: including the virus’ main protease, M pro .
−Removed: Several of these compounds were synthesized and tested in in vitro
−Removed: biological assays.
−Removed: Upon completion of these biological assays, we identified two of the most promising compounds and tested them in animal
−Removed: In these animal studies, the two compounds were compared to Remdesivir, which at the time the assays were performed was the only
−Removed: anti-viral drug authorized by the FDA for COVID-19.
−Removed: The data showed that administration of the drugs to infected hamsters did not cause
−Removed: any noticeable adverse effects, and monitoring of weight and general animal behavior demonstrated comparable efficacy between each of
−Removed: our compounds and Remdesivir.
−Removed: Based on this promising data in the animal study, we directed our team to proceed to the next stage of
−Removed: drug development and we selected one of the compounds around which our team is performing combinatorial synthetic medicinal chemistry
−Removed: to evaluate whether potency can be increased and pharmacokinetics optimized.
−Removed: May 2021, after completion of the aforementioned animal studies, OntoChem assigned its rights and obligations related to this collaboration
−Removed: to MolGenie GmbH (“MolGenie”), a company spun-out from OntoChem focused on drug discovery and development.
−Removed: As a result of
−Removed: the MolGenie spin-out, there was no change in the personnel working on our project, and the assignment caused no interruptions to the
−Removed: program’s development.
−Removed: use of preventative vaccines is widespread throughout much of the developed world, we believe that there is and will continue to be a
−Removed: need for effective treatments for COVID-19.
−Removed: We believe that there are a number of factors that have limited the effectiveness, both in
−Removed: the near and long term, of the vaccines currently in use, including, but not limited to, vaccine persistence, viral escape and perceptions
−Removed: of long-term safety resulting in vaccine resistance.
−Removed: Furthermore, there are currently two new anti-viral treatments, Pfizer’s Paxlovid,
−Removed: which is a combination therapy consisting of the protease-inhibitor nirmatrelvir and the antiretroviral ritonavir and Merck’s polymerase-inhibitor
−Removed: molnupiravir, that have recently been authorized for emergency use in the U.S.
−Removed: These treatments use oral formulations, while all other
−Removed: currently authorized or approved treatments require intravenous administration.
−Removed: As the main component of Pfizer’s treatment is
−Removed: a protease-inhibitor targeting M pro , it is most similar to our compounds, and we therefore conducted a head-to-head analysis
−Removed: via a Fluorescence Resonance Energy Transfer (FRET) assay that tested the ability of the compounds to inhibit the function of M pro .
−Removed: The results of this head-to-head in vitro analysis suggest that our compounds may be five times more effective at inhibiting M pro
−Removed: than Pfizer’s nirmatrelvir.
+Added: Our vaccine programs include (i) the development of a preventative vaccine against triple
+Added: negative breast cancer (“TNBC”), the most lethal form of breast cancer, as well other forms of breast cancer and (ii) the
+Added: development of a preventative vaccine against ovarian cancer.
+Added: Our therapeutics programs include (i) the development of a chimeric endocrine
+Added: receptor T-cell therapy, a novel form of chimeric antigen receptor T-cell (“CAR-T”) technology, initially focused on treating
+Added: ovarian cancer, which is being developed at our subsidiary, Certainty Therapeutics, Inc.
+Added: (“Certainty”), and (ii) the development
+Added: of anti-viral drug candidates for the treatment of COVID-19 focused on inhibiting certain protein functions of the virus.
hold an exclusive worldwide, royalty-bearing license to use certain intellectual property owned or controlled by The Cleveland Clinic
7 unchanged sentences
Studies have shown that vaccinating against this protein prevents breast cancer in mice.
−Removed: the FDA’s authorization to proceed with clinical trials in December 2020, in October 2021, we commenced dosing patients in a Phase
−Removed: 1 clinical trial of our breast cancer vaccine.
−Removed: Funded by a U.S.
−Removed: Department of Defense grant, this study is a multiple-ascending dose
−Removed: Phase 1 trial to determine the maximum tolerated dose of the vaccine in patients with early-stage, triple-negative breast cancer as well
−Removed: as monitor immune response.
−Removed: The study is being conducted at Cleveland Clinic and will consist of 18 to 24 patients who have completed
−Removed: treatment for early-stage, triple-negative breast cancer within the past three years and are currently tumor-free but at high risk for
−Removed: During the course of the study, participants will receive three vaccinations, each two weeks apart, and will be closely monitored
−Removed: for side effects and immune response.
−Removed: The study is roughly one-fourth of the way complete and is estimated to be completed by the end
−Removed: of calendar year 2022.
−Removed: Initial indications suggest that an immune response is being observed.
+Added: Food and Drug Administration’s (“FDA”) authorization to proceed with clinical trials in December 2020, in
+Added: October 2021, we commenced dosing patients in a Phase 1 clinical trial of our breast cancer vaccine.
+Added: This study, which is being funded
+Added: Department of Defense grant, is a multiple-ascending dose Phase 1 trial to determine the maximum tolerated dose (“MTD”)
+Added: of the vaccine in patients with early-stage, triple-negative breast cancer as well as monitor immune response.
+Added: The study is being conducted
+Added: at Cleveland Clinic and will consist of 18 to 24 patients who have completed treatment for early-stage, triple-negative breast cancer
+Added: within the past three years and are currently tumor-free but at high risk for recurrence.
+Added: During the course of the study, participants
+Added: will receive three vaccinations, each two weeks apart, and will be closely monitored for side effects and immune response.
+Added: Initial indications
+Added: from preliminary analyses suggest that an immune response is being observed.
+Added: In December 2022, we announced that we had reached the MTD.
+Added: We are currently compiling and analyzing the data collected to-date and anticipate presenting the immunological data at the annual meeting
+Added: of the American Association for Cancer Research to be held in April 2023.
+Added: Upon reaching MTD, we are now expanding the dose cohorts and
+Added: are vaccinating additional participants.
+Added: Further, we have commenced recruitment for participants in the second stage of our Phase 1 trial,
+Added: that will include participants who have never had cancer, but carry certain genetic mutations that indicate a greater risk of developing
+Added: TNBC in the future.
November 2020, we executed a license agreement with Cleveland Clinic pursuant to which the Company was granted an exclusive worldwide,
6 unchanged sentences
While expression of AMHR2-ED naturally and markedly
−Removed: declines after menopause, this protein is expressed at high levels in the ovaries of postmenopausal women with ovarian cancer.
+Added: declines during menopause, this protein is expressed at high levels in the ovaries of postmenopausal women with ovarian cancer.
at Cleveland Clinic believe that a vaccine targeting AMHR2-ED could prevent the occurrence of ovarian cancer.
5 unchanged sentences
The PREVENT program is a peer-reviewed agent development program
−Removed: designed to support preclinical development of innovative interventions and biomarkers for cancer prevention and interception towards
+Added: designed to support pre-clinical development of innovative interventions and biomarkers for cancer prevention and interception towards
clinical trials.
1 unchanged sentence
to perform virtually all pre-clinical research and development, manufacturing and IND-enabling studies.
−Removed: This work will be performed at
−Removed: NCI facilities, by NCI scientific staff and with NCI financial resources and will require no material financial expenditures by the Company,
−Removed: nor the transfer of any rights to the Company’s assets.
−Removed: the next several quarters, we expect the development of our breast and ovarian cancer vaccines, our COVID-19 therapeutic discovery program
−Removed: and Certainty’s CAR-T technology to be the primary focus of the Company.
−Removed: As part of our legacy operations, the Company remains
−Removed: engaged in limited patent licensing activities regarding its liquid biopsy platform and in the area of encrypted audio/video conference
−Removed: We do not expect these activities to be a significant part of the Company’s ongoing operations nor do we expect these
−Removed: activities to require material financial resources or attention of senior management.
+Added: This work is being performed
+Added: at NCI facilities, by NCI scientific staff and with NCI financial resources and will require no material financial expenditures by the
+Added: Company, nor the transfer of any rights of the Company’s assets.
+Added: subsidiary, Certainty, is developing immuno-therapy drugs against cancer.
+Added: Certainty holds an exclusive worldwide, royalty-bearing license
+Added: to use certain intellectual property owned or controlled by The Wistar Institute (“Wistar”), the nation’s first independent
+Added: biomedical research institute and a leading National Cancer Institute designated cancer research center, relating to Wistar’s chimeric
+Added: endocrine receptor targeted therapy technology.
+Added: We have initially focused on the development of a treatment for ovarian cancer, but we
+Added: also may pursue applications of the technology for the development of treatments for additional solid tumors.
+Added: The license agreement requires
+Added: Certainty to make certain cash and equity payments to Wistar upon achievement of specific development milestones.
+Added: With respect to Certainty’s
+Added: equity obligations to Wistar, Certainty issued to Wistar shares of its common stock equal to five percent ( 5 %) of the common stock of
+Added: in collaboration with the H.
+Added: Lee Moffitt Cancer Center and Research Institute, Inc.
+Added: (“Moffitt”), has begun human
+Added: clinical testing of the CAR-T technology licensed by Certainty from Wistar aimed initially at treating ovarian cancer.
+Added: We received authorization
+Added: from the FDA in August 2021, to commence enrollment and treatment of patients in a Phase 1 clinical trial.
+Added: We began patient recruitment
+Added: for the trial in March 2022, and in August 2022, we treated the first patient in the trial.
+Added: The treatment appears to have been well-tolerated
+Added: by the patient, and we continue to monitor her condition.
+Added: The process of recruiting additional patients is ongoing.
+Added: This study is a dose-escalation
+Added: trial with two arms based on injection method—intraperitoneal or intravenous—to determine the maximum tolerated dose in patients
+Added: with recurrent epithelial ovarian cancer and to assess persistence, expansion and efficacy of the modified T-cells.
+Added: The study is being
+Added: conducted at Moffitt and will consist of 24 to 48 patients who have received at least two prior lines of chemotherapy.
+Added: The study is estimated
+Added: to be completed in two to four years depending on multiple factors including when maximum tolerated dose is reached, the rate of patient
+Added: recruitment, and how long we maintain the two different injection methods.
+Added: April 2020, we entered into a collaboration with OntoChem GmbH (“OntoChem”) to discover and ultimately develop anti-viral
+Added: drug candidates against COVID-19.
+Added: Through this collaboration, we utilized advanced computational methods, machine learning, and molecular
+Added: modeling techniques to perform in silico screening of over 1.2 billion compounds in chemical libraries (including publicly available
+Added: compounds and OntoChem’s proprietary libraries) to evaluate if any of these compounds could disrupt one of two key enzymes of SARS-CoV-2,
+Added: the virus that causes the disease COVID-19.
+Added: In May 2021, OntoChem assigned its rights and obligations related to this collaboration to
+Added: MolGenie GmbH (“MolGenie”), a company spun-out from OntoChem focused on drug discovery and development.
+Added: As a result of the
+Added: MolGenie spin-out, there was no change in the personnel working on our project, and the assignment caused no interruptions to the program’s
+Added: screening process resulted in the identification of multiple compounds that could potentially disrupt critical enzymes of the virus,
+Added: including the virus’ main protease, M pro .
+Added: Several of these compounds were synthesized and tested in in vitro
+Added: biological assays.
+Added: Upon completion of these biological assays, we identified two of the most promising compounds and tested them in
+Added: animal models.
+Added: In these animal studies, the two compounds were compared to Remdesivir, which at the time the assays were performed
+Added: was the only anti-viral drug authorized by the FDA for COVID-19.
+Added: The data showed that administration of the drugs to infected
+Added: hamsters did not cause any noticeable adverse effects, and monitoring of weight and general animal behavior demonstrated comparable
+Added: efficacy between each of our compounds and Remdesivir.
+Added: Further, with the authorization of
+Added: Pfizer’s anti-viral treatment Paxlovid, which is a combination therapy consisting of the protease-inhibitor
+Added: nirmatrelvir—which targets the same protein as our compounds—and the antiretroviral ritonavir, we conducted a
+Added: head-to-head analysis via a Fluorescence Resonance Energy Transfer (FRET) assay that tested the ability of the compounds to inhibit
+Added: the function of M pro .
+Added: The results of this
+Added: head-to-head in vitro analysis suggested that our compounds may be five times more effective at inhibiting M pro than
+Added: Pfizer’s nirmatrelvir.
+Added: Based on these promising results, we selected one of the compounds around which our team has
+Added: been performing combinatorial synthetic medicinal chemistry to evaluate whether potency can be increased and pharmacokinetics
+Added: While our compounds show promise as an effective treatment, results of additional animal studies indicate that there is
+Added: not sufficient oral bioavailability, and it is unclear whether an orally
+Added: delivered treatment may be developed.
+Added: We do not currently believe that there is a viable market for an injectable treatment given the current oral
+Added: treatments available.
+Added: Furthermore, we believe the needed additional investment in research for alternative delivery methods would
+Added: divert resources from more promising projects.
+Added: Therefore, on March 9, 2023, we decided to pause further development of our COVID-19
+Added: We continue to prosecute our U.S.
+Added: patent applications of this technology and may decide to restart development at some
+Added: time in the future.
+Added: the next several quarters, we expect the development of our vaccines and therapeutics to be the primary focus of the Company.
+Added: of our legacy operations, the Company remains engaged in limited patent licensing activities regarding its liquid biopsy platform, as
+Added: well as in the area of encrypted audio/video conference calling.
+Added: We do not expect these activities to be a significant part of the Company’s
+Added: ongoing operations nor do we expect these activities to require material financial resources or attention of senior management.
the past several years, our revenue was derived from technology licensing and the sale of patented technologies, including revenue from
the settlement of litigation.
−Removed: We have not generated any revenue to date from our therapeutics or vaccine programs.
+Added: We have not generated any revenue to date from our vaccine or therapeutics programs.
In addition, while
−Removed: we pursue our therapeutics and vaccine programs, we may also make investments in and form new companies to develop additional emerging
+Added: we pursue our vaccine and therapeutics programs, we may also make investments in and form new companies to develop additional emerging
technologies.
−Removed: We do not expect to begin generating revenue with respect to any of our current therapy or vaccine programs in the near
−Removed: Our strategy is to achieve a profitable outcome by eventually licensing our technologies to large pharmaceutical companies that
−Removed: have the resources and infrastructure in place to manufacture, market and sell our technologies as therapeutics or vaccines.
−Removed: 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
−Removed: clinical trials.
+Added: We do not expect to begin generating revenue with respect to any of our current vaccine or therapy programs in the near
+Added: We hope to achieve a profitable outcome by eventually licensing our technologies to large pharmaceutical companies that have the
+Added: resources and infrastructure in place to manufacture, market and sell our technologies as vaccines or therapeutics.
+Added: The eventual licensing
+Added: 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.
and Management’s Plans
−Removed: on currently available information as of September 9, 2022, we believe that our existing cash, cash equivalents, short-term
−Removed: investments and expected cash flows will be sufficient to fund our activities for at least the next twelve months.
−Removed: implemented a business model that conserves funds by collaborating with third parties to develop our technologies.
−Removed: projections of future cash needs and cash flows may differ from actual results.
−Removed: If current cash on hand, cash equivalents,
−Removed: short-term investments and cash that may be generated from our business operations are insufficient to continue to operate our
−Removed: business, or if we elect to invest in or acquire a company or companies or new technology or technologies that are synergistic with
−Removed: or complementary to our technologies, we may desire or be required to obtain more working capital.
−Removed: We may seek to obtain working
−Removed: capital during our fiscal year 2022 or thereafter through sales of our equity securities (including, but not limited to, sales
−Removed: through an at-the-market offering program under a universal shelf registration statement) or through bank credit facilities or public or
−Removed: private debt from various financial institutions where possible.
−Removed: We cannot be certain that additional funding will be available on
−Removed: acceptable terms, or at all.
−Removed: If we do identify sources for additional funding, the sale of additional equity securities or
−Removed: convertible debt will result in dilution to our stockholders.
−Removed: We can give no assurance that we will generate sufficient cash flows
−Removed: in the future to satisfy our liquidity requirements or sustain future operations, or that other sources of funding, such as sales of
−Removed: equity or debt, would be available or would be approved by our security holders, if needed, on favorable terms or at all.
−Removed: to obtain additional working capital as and when needed, such failure could have a material adverse impact on our business, results
−Removed: of operations and financial condition.
−Removed: Furthermore, such lack of funds may inhibit our ability to respond to competitive pressures
−Removed: or unanticipated capital needs, or may force us to reduce operating expenses, which would significantly harm the business and
−Removed: development of operations.
+Added: on currently available information as of March 16, 2023, we believe that our existing cash, cash equivalents, short-term investments
+Added: and expected cash flows will be sufficient to fund our activities for at least the next twelve months.
+Added: We have implemented a business
+Added: model that conserves funds by collaborating with third parties to develop our technologies.
+Added: However, our projections of future cash needs
+Added: and cash flows may differ from actual results.
+Added: If current cash on hand, cash equivalents, short-term investments and cash that may be
+Added: generated from our business operations are insufficient to continue to operate our business, or if we elect to invest in or acquire a
+Added: company or companies or new technology or technologies that are synergistic with or complementary to our technologies, we may be required
+Added: to obtain more working capital.
+Added: Under our at-the-market equity program, as of January 31, 2023, we may sell up to $ 100
+Added: million of common stock.
+Added: We did not sell any
+Added: shares under our at-the-market equity program during the three months ended January 31, 2023.
+Added: We may seek to obtain working capital during
+Added: our fiscal year 2023 or thereafter through sales of our equity securities or through bank credit facilities or public or private debt
+Added: from various financial institutions where possible.
+Added: We cannot be certain that additional funding will be available on acceptable terms,
+Added: If we do identify sources for additional funding, the sale of additional equity securities or convertible debt will result
+Added: in dilution to our stockholders.
+Added: We can give no assurance that we will generate sufficient cash flows in the future to satisfy our liquidity
+Added: requirements or sustain future operations, or that other sources of funding, such as sales of equity or debt, would be available or would
+Added: be approved by our security holders, if needed, on favorable terms or at all.
+Added: If we fail to obtain additional working capital as and
+Added: when needed, such failure could have a material adverse impact on our business, results of operations and financial condition.
+Added: such lack of funds may inhibit our ability to respond to competitive pressures or unanticipated capital needs, or may force us to reduce
+Added: operating expenses, which would significantly harm the business and development of operations.
+Added: SIGNIFICANT ACCOUNTING POLICIES
of Presentation
10 unchanged sentences
The condensed consolidated financial statements include all adjustments of a normal recurring nature which, in the opinion
−Removed: of management, are necessary for a fair statement of our financial position as of July 31, 2022, and results of operations and cash
−Removed: flows for the interim periods presented.
−Removed: The results of operations for the three and nine months ended July 31, 2022 are not
−Removed: necessarily indicative of the results to be expected for the entire year.
+Added: of management, are necessary for a fair statement of our financial position as of January 31, 2023, and results of operations and
+Added: cash flows for the interim periods represented.
+Added: The results of operations for the three months ended January 31, 2023 are not
+Added: necessarily indicative of the results to be expected for the year.
Noncontrolling
2 unchanged sentences
The following table sets
−Removed: forth the changes in noncontrolling interest for the nine months ended July 31, 2022 (in thousands):
−Removed: SCHEDULE OF NONCONTROLLING INTEREST AS A COMPONENT OF EQUITY
−Removed: Balance, October 31, 2021
−Removed: Net loss attributable
−Removed: to noncontrolling interest
−Removed: Balance, July 31, 2022
+Added: forth the changes in noncontrolling interest for the three months ended January 31, 2023 (in thousands):
+Added: OF CHANGES IN NONCONTROLLING INTEREST
+Added: October 31, 2022
+Added: loss attributable to noncontrolling interest
+Added: January 31, 2023
revenue has been derived solely from technology licensing and the sale of patented technologies.
20 unchanged sentences
Accordingly, the performance obligations from
−Removed: these agreements were satisfied and 100 % of the revenue was recognized upon the execution of the agreements.
+Added: these arrangements are satisfied and 100 % of the revenues are recognized upon execution of the agreements.
of revenues include the costs and expenses incurred in connection with our patent licensing and enforcement activities, including inventor
4 unchanged sentences
and Development Expenses
−Removed: and development expenses, consisting primarily of employee compensation, payments to third parties for research and development activities, including expenses related to clinical trials,
+Added: 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,
1 unchanged sentence
in the period incurred.
−Removed: SHARE BASED COMPENSATION
−Removed: Company maintains equity incentive plans under which the Company grants incentive stock options, non-qualified stock options, stock
+Added: Investment Policy
+Added: The Company’s investment
+Added: policy is to acquire debt securities with fixed maturities and contractual cash flows that the Company has the positive intent and ability
+Added: to hold to maturity.
+Added: These securities are recorded at amortized cost, net of any applicable discount which is amortized to interest income,
+Added: and are accounted for as held-to-maturity securities.
+Added: STOCK BASED COMPENSATION
+Added: Company maintains stock equity incentive plans under which the Company grants incentive stock options, non-qualified stock options, stock
appreciation rights, stock awards, performance awards, or stock units to employees, directors and consultants.
3 unchanged sentences
(the vesting period of the stock option) which is one to four years.
−Removed: We recorded share-based compensation expense related to service-based
−Removed: stock options granted to employees and directors of approximately $ 941,000 and $ 1,066,000 during the three months ended July 31, 2022
−Removed: and 2021, respectively, and approximately $ 2,546,000 and $ 2,822,000 during the nine months ended July 31, 2022 and 2021, respectively.
+Added: We recorded stock-based compensation expense related to service-based
+Added: stock options granted to employees and directors of approximately $ 957,000 and $ 730,000 during the three months ended January 31, 2023
stock options granted to employees and directors that vest based on market conditions, such as the trading price of the Company’s
1 unchanged sentence
compensation cost over the implied service period (median time to vest).
−Removed: On June 1, 2021, our Chairman and Chief Executive Officer and
−Removed: our President, Chief Operating Officer and Chief Financial Officer were awarded market condition stock options for 2,000,000 shares and
−Removed: 100,000 shares of common stock, respectively, that vest in four equal installments upon the Company’s share price achieving targets
−Removed: ranging from $ 5.00 to $ 8.00 per share, with implied service periods of three to fifteen months.
−Removed: We recorded market condition stock-based
−Removed: compensation expense during the three months ended July 31, 2022 and 2021 of approximately $ 388,000 and $ 1,981,000 , respectively, and
−Removed: approximately $ 2,381,000 and $ 1,981,000 during the nine months ended July 31, 2022 and 2021, respectively.
+Added: On June 1, 2021, our Chairman, then-President and Chief Executive
+Added: Officer and our Chief Operating Officer and Chief Financial Officer were awarded market condition stock options for 2,000,000 shares
+Added: and 100,000 shares of common stock, respectively, that vest in four equal installments upon the Company’s share price achieving
+Added: targets ranging from $ 5.00 to $ 8.00 per share, with implied service periods of three to fifteen months.
+Added: We recorded market condition
+Added: stock-based compensation expense during the three months ended January 31, 2023 and 2022 of $ 0 and approximately $ 1,405,000 , respectively.
compensation cost for service-based stock options granted to consultants is measured at the grant date, based on the fair value of the
2 unchanged sentences
We recorded stock-based consulting expense related to stock options granted
−Removed: to consultants of approximately $ 109,000 and $ 139,000 during the three months ended July 31, 2022 and 2021, respectively, and approximately
−Removed: $ 546,000 and $ 421,000 during the nine months ended July 31, 2022 and 2021, respectively.
−Removed: the three months ended July 31, 2022, we had two stock option plans:
+Added: to consultants of approximately $ 81,000 and $ 109,000 during the three months ended January 31, 2023 and 2022, respectively.
+Added: the three months ended January 31, 2023, we had two stock option plans:
the Anixa Biosciences, Inc.
1 unchanged sentence
Share Plan”) and the Anixa Biosciences, Inc.
−Removed: 2018 Share Incentive Plan (the “2018 Share Plan”), which
−Removed: were adopted by our Board of Directors on July 14, 2010 and January 25, 2018, respectively.
−Removed: The 2018 Share Plan was approved by our
−Removed: shareholders on March 29, 2018.
+Added: 2018 Share Incentive Plan (the “2018 Share Plan”), which were adopted
+Added: by our Board of Directors on July 14, 2010 and January 25, 2018, respectively.
+Added: The 2018 Share Plan was approved by our shareholders on
+Added: March 29, 2018.
Option Activity
−Removed: the three months ended July 31, 2022 and 2021, we granted options to purchase 0 shares and 120,000 shares of common stock, respectively,
−Removed: and during the nine months ended July 31, 2022 and 2021, we granted options to purchase 1,430,000 shares and 1,500,000 shares of common
−Removed: stock, respectively, to employees and consultants, with exercise prices ranging from $ 2.62 to $ 5.30 per share, pursuant to the 2018 Share
−Removed: During the three months ended July 31, 2022, stock options to purchase 1,001,388 shares of common stock, net of 505,340 shares
−Removed: withheld on a cashless exercise, were exercised with aggregate proceeds of $ 830,000 .
−Removed: During the three months ended July 31, 2021, no
−Removed: stock options were exercised.
−Removed: During the nine months ended July 31, 2022 and 2021, stock options to purchase 1,101,388 shares of common
−Removed: stock, net of 558,431 shares withheld on a cashless exercise, and 115,388 shares of common stock, net of 7,937 shares withheld on a cashless
−Removed: exercise, respectively, were exercised with aggregate proceeds of $ 830,000 and $ 293,000 , respectively.
+Added: the three months ended January 31, 2023 and 2022, we granted options to purchase 1,505,000 shares and 30,000 shares of common stock,
+Added: respectively, to employees and consultants, with exercise prices ranging from $ 4.19 to $ 4.81 per share, pursuant to the 2018 Share Plan.
+Added: During the three months ended January 31, 2023 and 2022, stock options to purchase 2,372 shares of common stock, net of 808 shares withheld
+Added: on a cashless exercise, and 100,000 shares of common stock, net of 53,091 shares withheld on a cashless exercise, respectively, were
+Added: exercised with aggregate proceeds of approximately $ 3,000 and $ 0 , respectively.
2010 Share Plan provided for the grant of nonqualified stock options, stock appreciation rights, stock awards, performance awards and
2 unchanged sentences
respect to the ability to grant future awards on July 14, 2020.
−Removed: Information regarding the 2010 Share Plan for the nine months ended July
−Removed: 31, 2022 is as follows:
−Removed: SCHEDULE OF OPTION ACTIVITY
+Added: Information regarding the 2010 Share Plan for the three months ended
+Added: January 31, 2023 is as follows:
+Added: OF OPTION ACTIVITY
Average Exercise
2 unchanged sentences
(in thousands)
−Removed: Options outstanding at October 31, 2021
−Removed: Options outstanding and exercisable at July
−Removed: following table summarizes information about stock options outstanding and exercisable under the 2010 Share Plan as of July 31, 2022:
−Removed: SCHEDULE OF OUTSTANDING AND EXERCISABLE
+Added: outstanding at October 31, 2022
+Added: outstanding and exercisable at January 31, 2023
+Added: following table summarizes information about stock options outstanding and exercisable under the 2010 Share Plan as of January 31, 2023:
+Added: OF OUTSTANDING AND EXERCISABLE
+Added: Exercise Prices
+Added: Outstanding and
+Added: Weighted Average
+Added: Contractual Life
+Added: Exercise Price
+Added: $ 0.67 - $ 2.27
+Added: $ 2.58 - $ 3.13
+Added: $ 3.46 - $ 5.30
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.
−Removed: As of July 31, 2022, the 2018 Share Plan had 600,000
−Removed: shares available for future grants.
−Removed: regarding the 2018 Share Plan for the nine months ended July 31, 2022 is as follows:
+Added: As of January 31, 2023, the 2018 Share Plan had 675,000 shares
+Added: available for future grants.
+Added: Information regarding the 2018 Share Plan for the three months ended January 31, 2023 is as follows:
OF OPTION ACTIVITY
4 unchanged sentences
outstanding at October 31, 2022
−Removed: outstanding at July 31, 2022
−Removed: exercisable at July 31, 2022
−Removed: following table summarizes information about stock options outstanding and exercisable under the 2018 Share Plan as of July 31, 2022:
−Removed: SCHEDULE OF OUTSTANDING AND EXERCISABLE
−Removed: addition to options granted under stock option plans, during the years ended October 31, 2012 and 2013, the Board of Directors approved
−Removed: the grant of stock options to certain employees and directors.
−Removed: Information regarding stock options that were granted outside of share
−Removed: plans for the nine months ended July 31, 2022 is as follows:
−Removed: SCHEDULE OF OPTION ACTIVITY
−Removed: Average Exercise
−Removed: Price Per Share
−Removed: Intrinsic Value
−Removed: (in thousands)
−Removed: Options outstanding at October 31, 2021
+Added: outstanding at January 31, 2023
+Added: exercisable at January 31, 2023
+Added: following table summarizes information about stock options outstanding and exercisable under the 2018 Share Plan as of January 31, 2023:
+Added: OF OUTSTANDING AND EXERCISABLE
Options Outstanding
−Removed: and exercisable at July 31, 2022
−Removed: following table summarizes information about stock options outstanding and exercisable that were granted outside of share plans as of
−Removed: July 31, 2022:
−Removed: SCHEDULE OF OUTSTANDING AND EXERCISABLE
−Removed: Average Remaining Contractual Life
+Added: Options Exercisable
+Added: Exercise Prices
+Added: Contractual Life
+Added: Exercise Price
+Added: Contractual Life
+Added: Exercise Price
+Added: $ 2.09 - $ 3.87
+Added: $ 3.96 - $ 5.30
Stock Purchase Plan
5 unchanged sentences
by our shareholders on September 27, 2018.
−Removed: During the nine months ended July 31, 2022 and 2021, employees purchased 2,389 and 1,634 shares,
−Removed: respectively, with aggregate proceeds of approximately $ 7,000 and $ 3,000 , respectively.
−Removed: 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
−Removed: over five months , to a consultant for investor relations services.
−Removed: We recorded consulting expense of approximately $ 0 and $ 96,000 , respectively,
−Removed: during the three and nine months ended July 31, 2021, based on the fair value of the warrant on the date of grant recognized on a straight-line
−Removed: basis over the vesting period.
−Removed: On November 16, 2021, the warrant was exercised on a cashless basis and 25,484 shares were withheld as
+Added: During the three months ended January 31, 2023 and 2022, no shares were purchased under the
+Added: On October 30, 2020 we issued
+Added: 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
+Added: consultant for investor relations services.
+Added: On November 16, 2021, the warrant was exercised on a cashless basis and 25,484 shares were
+Added: withheld as payment.
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.
−Removed: We recorded consulting expense of approximately $ 0 and $ 220,000 , respectively,
−Removed: 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
−Removed: basis over the vesting period.
+Added: We recorded consulting expense of approximately $ 110,000 during the
+Added: three months ended January 31, 2022, based on the fair value of the warrant on the date of grant recognized on a straight-line basis
+Added: over the vesting period.
The warrant terminated in May 2022 upon termination of the consulting agreement.
−Removed: of July 31, 2022, we also had warrants outstanding to purchase 300,000 shares of common stock at $ 6.56 per share, issued during fiscal
+Added: of January 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 .
−Removed: FAIR VALUE MEASUREMENTS
+Added: regarding the Company’s warrants for the three months ended January 31, 2023 is as follows:
+Added: SCHEDULE OF WARRANTS
+Added: Average Exercise
+Added: Price Per Share
+Added: Outstanding at October 31, 2022
+Added: Outstanding and Exercisable at January 31, 2023
+Added: following table summarizes information about the Company’s outstanding and exercisable warrants as of January 31, 2023:
+Added: SCHEDULE OF OUTSTANDING
+Added: AND EXERCISABLE
+Added: VALUE MEASUREMENTS
GAAP defines fair value and establishes a framework for measuring fair value.
6 unchanged sentences
valuation techniques as follows:
−Removed: 1 – Financial assets and liabilities whose values are based on unadjusted quoted prices for identical assets or liabilities in
−Removed: an active market which we have the ability to access at the measurement date.
−Removed: 2 – Financial assets and liabilities whose values are based on quoted market prices in markets where trading occurs infrequently
−Removed: or whose values are based on quoted prices of instruments with similar attributes in active markets.
−Removed: 3 – Financial assets and liabilities whose values are based on prices or valuation techniques that require inputs that are both
−Removed: unobservable and significant to the overall fair value measurement.
−Removed: These inputs reflect management’s own assumptions about the
−Removed: assumptions a market participant would use in pricing the asset and liabilities.
−Removed: following table presents the hierarchy for our financial assets measured at fair value on a recurring basis as of July 31, 2022:
−Removed: SCHEDULE OF FAIR VALUE MEASUREMENTS
−Removed: (in thousands)
−Removed: Money market funds:
−Removed: Cash equivalents
−Removed: Certificates of deposit:
−Removed: Cash equivalents
−Removed: Short-term investments
−Removed: Total financial assets
−Removed: following table presents the hierarchy for our financial assets measured at fair value on a recurring basis as of October 31, 2021:
−Removed: (in thousands)
−Removed: Money market funds:
−Removed: Cash equivalents
+Added: 1 – Financial instruments whose values are based on unadjusted quoted prices for identical assets or liabilities in an active market
+Added: which we have the ability to access at the measurement date.
+Added: 2 – Financial instruments whose values are based on quoted market prices in markets where trading occurs infrequently or whose
+Added: values are based on quoted prices of instruments with similar attributes in active markets.
+Added: 3 – Financial instruments whose values are based on prices or valuation techniques that require inputs that are both unobservable
+Added: and significant to the overall fair value measurement.
+Added: These inputs reflect management’s own assumptions about the assumptions
+Added: a market participant would use in pricing the instrument.
+Added: following table presents the hierarchy for our financial assets measured at fair value on a recurring basis as of January 31, 2023 (in
+Added: OF FAIR VALUE MEASUREMENTS
+Added: market funds:
Certificates of deposit:
−Removed: Short term investments
treasury bills:
−Removed: Total financial assets
−Removed: estimated fair value of prepaid expenses and other current assets and accounts payable approximates their individual carrying amounts
−Removed: due to the short-term nature of these instruments.
−Removed: Cash balances are stated at carrying value which approximates fair value.
+Added: financial assets
+Added: following table presents the hierarchy for our financial assets measured at fair value on a recurring basis as of October 31, 2022 (in
+Added: market funds:
+Added: term investments
+Added: treasury bills:
+Added: financial assets
+Added: non-financial assets that are measured on a non-recurring basis are property and equipment and other assets which are measured using
+Added: fair value techniques whenever events or changes in circumstances indicate a condition of impairment exists.
+Added: The estimated fair value
+Added: of prepaid expenses and other current assets, accounts payable and accrued expenses approximates their individual carrying amounts due
+Added: to the short-term nature of these measurements.
+Added: Cash equivalents are stated at carrying value which approximates fair value.
ACCRUED EXPENSES
1 unchanged sentence
OF ACCRUED EXPENSES
−Removed: (in thousands)
−Removed: Payroll and related expenses
−Removed: Accrued royalty and contingent legal fees
−Removed: Accrued other
−Removed: NET LOSS PER SHARE OF COMMON STOCK
+Added: and related expenses
+Added: royalty and contingent legal fees
+Added: LOSS PER SHARE OF COMMON STOCK
net loss per common share (“Basic EPS”) is computed by dividing net loss by the weighted average number of common shares
3 unchanged sentences
is the same as Basic EPS, as the inclusion of the effect of common share equivalents then outstanding would be anti-dilutive.
−Removed: reason, excluded from the calculation of Diluted EPS for the nine months ended July 31, 2022 and 2021, were stock options to purchase
+Added: reason, excluded from the calculation of Diluted EPS for the three months ended January 31, 2023 and 2022, were stock options to purchase
11,821,500 and 10,700,626 shares, respectively, and warrants to purchase 300,000 and 360,000 shares, respectively.
−Removed: EFFECT OF RECENTLY ADOPTED AND ISSUED PRONOUNCEMENTS
+Added: OF RECENTLY ADOPTED AND ISSUED PRONOUNCEMENTS
January 2020, the FASB issued Accounting Standards Update 2020-01 (“ASU 2020-01”) Investments-Equity Securities (Topic 321),
11 unchanged sentences
The adoption of this standard did not have a material impact
−Removed: on our condensed consolidated financial statements and related disclosures.
+Added: on our consolidated financial statements and related disclosures.
August 2020, the FASB issued Accounting Standards Update 2020-06 (“ASU 2020-06”), Accounting for Convertible Instruments
7 unchanged sentences
within those fiscal years.
−Removed: We do not expect the adoption of this standard to have a material impact on our condensed consolidated financial
−Removed: statements and related disclosures.
−Removed: May 2021, the FASB issued Accounting Standards Update 2021-04 (“ASU No.
−Removed: 2021-04”), Issuer’s Accounting for Certain
−Removed: Modifications or Exchanges of Freestanding Equity-Classified Written Call Options.
−Removed: The guidance in ASU 2021-04 requires the issuer to
−Removed: treat a modification of an equity-classified written call option (the “option”) that does not cause the option to become
−Removed: liability-classified as an exchange of the original option for a new option.
−Removed: This guidance applies whether the modification is structured
−Removed: as an amendment to the terms and conditions of the option or as termination of the original option and issuance of a new option.
−Removed: amendments in this update are effective for fiscal years beginning after December 15, 2021, including interim periods within those fiscal
−Removed: We do not expect the adoption of this standard to have a material impact on our condensed consolidated financial statements and
+Added: The adoption of this standard did not have a material impact on our consolidated financial statements and
related disclosures.
−Removed: October 2021, the FASB issued Accounting Standards Update 2021-08 (“ASU No.
−Removed: 2021-08”), Business Combinations (Topic 805):
−Removed: Accounting for Contract Assets and Contract Liabilities from Contracts with Customers, to require that an acquirer recognize and measure
−Removed: contract assets and contract liabilities acquired in a business combination in accordance with Topic 606, Revenue from Contracts with
−Removed: At the acquisition date, an acquirer should account for the related revenue contracts in accordance with Topic 606 as if it
−Removed: had originated the contracts.
−Removed: The amendments in this update should be applied prospectively and are effective for fiscal years beginning
−Removed: after December 15, 2022, including interim periods within those fiscal years.
−Removed: We do not expect the adoption of this standard to have
−Removed: a material impact on our condensed consolidated financial statements and related disclosures.
+Added: May 2021, the FASB issued Accounting Standards Update 2021-04 (“ASU 2021-04”), Issuer’s Accounting for Certain Modifications
+Added: or Exchanges of Freestanding Equity-Classified Written Call Options.
+Added: The guidance in ASU 2021-04 requires the issuer to treat a modification
+Added: of an equity-classified written call option (the “option”) that does not cause the option to become liability-classified
+Added: as an exchange of the original option for a new option.
+Added: This guidance applies whether the modification is structured as an amendment
+Added: to the terms and conditions of the option or as termination of the original option and issuance of a new option.
+Added: The amendments in this
+Added: update are effective for fiscal years beginning after December 15, 2021, including interim periods within those fiscal years.
+Added: of this standard did not have a material impact on our consolidated financial statements and related disclosures.
+Added: October 2021, the FASB issued Accounting Standards Update 2021-08, Business Combinations (Topic 805):
+Added: Accounting for Contract Assets
+Added: and Contract Liabilities from Contracts with Customers, to require that an acquirer recognize and measure contract assets and contract
+Added: liabilities acquired in a business combination in accordance with Topic 606, Revenue from Contracts with Customers.
+Added: At the acquisition
+Added: date, an acquirer should account for the related revenue contracts in accordance with Topic 606 as if it had originated the contracts.
+Added: The amendments in this update should be applied prospectively and are effective for fiscal years beginning after December 15, 2022, including
+Added: interim periods within those fiscal years.
+Added: We do not expect the adoption of this standard to have a material impact on our consolidated
+Added: financial statements and related disclosures.
recognize deferred tax assets and liabilities for the estimated future tax effects of events that have been recognized in our financial
8 unchanged sentences
These net operating loss carryforwards
−Removed: could be subject to limitations under Internal Revenue Code section 382.
−Removed: We have no unrecognized income tax benefits as of July 31, 2022
−Removed: and October 31, 2021 and we account for interest and penalties related to income tax matters, if any, in general and administrative expenses.
+Added: could be subject to limitations under Internal Revenue Code section 382, the effects of which have not been determined by the Company.
+Added: We have no unrecognized income tax benefits as of January 31,
+Added: 2023 and October 31, 2022 and we account for interest and penalties related to income tax matters, if any, in general and administrative
lease approximately 2,000 square feet of office space at 3150 Almaden Expressway, San Jose, California (our principal executive offices)
6 unchanged sentences
with a discount rate of 10 %.
−Removed: Rent expense was approximately $ 17,000 and $ 16,000 , respectively, for the three months ended July 31, 2022
−Removed: and 2021, and approximately $ 50,000 and $ 48,000 , respectively, for the nine months ended July 31, 2022 and 2021.
+Added: Rent expense was approximately $ 17,000 and $ 17,000 , respectively, for the three months ended January 31,
+Added: 2023 and 2022.
operating leases, the lease liability is initially measured at the present value of the unpaid lease payments.
The remaining 44 -month
−Removed: lease term as of July 31, 2022 for the Company’s lease includes the noncancelable period of the lease and the additional two-year
−Removed: option period that the Company expects to exercise.
+Added: lease term as of January 31, 2023 for the Company’s lease includes the noncancelable period of the lease and the additional two-year
+Added: option period that the Company is reasonably certain to exercise.
All right-of-use assets are reviewed for impairment when indications of impairment
−Removed: of July 31, 2022, the expected annual minimum future lease payments of our operating lease liabilities were as follows:
+Added: of January 31, 2023, the annual minimum future lease payments of our operating lease liabilities were as follows (in thousands):
OF MINIMUM LEASE PAYMENTS
−Removed: Ended October 31,
−Removed: (in thousands)
−Removed: 2022 (remaining)
+Added: years Ended October 31,
future minimum lease payments, undiscounted
5 unchanged sentences
or financial condition.
−Removed: of Coronavirus Pandemic
−Removed: ongoing global outbreak of COVID-19 has resulted in significant governmental measures being implemented to control the spread of the
−Removed: virus, and while the breadth of these measures has been reduced recently, the Company cannot predict their scope or the severity of the
−Removed: outbreak in the future, and these developments and measures could materially and adversely affect the Company’s business, the operations
−Removed: of the Company’s collaboration partners, and the Company’s results of operations and financial condition.
−Removed: The Company is
−Removed: closely monitoring the impact of the COVID-19 pandemic on all aspects of its business and has taken steps to minimize its impact on the
−Removed: Company’s business.
−Removed: Although COVID-19 has not had a material adverse impact on the Company’s operations and its clinical
−Removed: and preclinical programs, the extent to which COVID-19 ultimately impacts the Company’s business, results of operations or financial
−Removed: condition will depend on future developments which are highly uncertain and cannot be predicted with confidence, such as the duration
−Removed: of the outbreak, the occurrence of new mutations of the SARS-CoV-2 virus, new information that may emerge concerning the severity of
−Removed: COVID-19 or the effectiveness of actions taken to contain the pandemic or mitigate its impact, among others.
−Removed: Certain of the Company’s
−Removed: collaboration partners have experienced shutdowns or other business disruptions.
−Removed: As a result, the Company’s ability to conduct
−Removed: its business in the manner and on the timelines presently planned could be materially or negatively affected, which could have a material
−Removed: adverse impact on the Company’s business, results of operations and financial condition.
−Removed: SEGMENT INFORMATION
follow the accounting guidance of ASC 280 “Segment Reporting” (“ASC 280”).
9 unchanged sentences
The following represents selected financial information for our segments for the three
−Removed: and nine months ended July 31, 2022 and 2021 and as of July 31, 2022 and October 31, 2021, in thousands:
+Added: months ended January 31, 2023 and 2022 and as of January 31, 2023 and October 31, 2022 (in thousands):
OF SEGMENT INFORMATION
−Removed: the Three Months
−Removed: the nine Months
−Removed: Ended July 31,
−Removed: CAR-T Therapeutics
−Removed: Cancer Vaccines
−Removed: Anti-Viral Therapeutics
−Removed: Total operating costs and expenses
−Removed: Less non-cash share-based
−Removed: costs and expenses excluding non-cash share-based compensation
+Added: the Three Months Ended
operating costs and expenses
−Removed: excluding non-cash share based compensation:
−Removed: CAR-T Therapeutics
−Removed: Cancer Vaccines
−Removed: Anti-Viral Therapeutics
−Removed: Operating costs and
−Removed: expenses excluding non-cash share based compensation
−Removed: Total assets:
−Removed: CAR-T Therapeutics
−Removed: Cancer Vaccines
−Removed: Anti-Viral Therapeutics
+Added: non-cash share-based compensation
+Added: costs and expenses excluding non-cash share-based compensation
+Added: costs and expenses excluding non-cash
+Added: share based compensation expense:
+Added: costs and expenses excluding non-cash based compensation
costs and expenses excluding non-cash share-based compensation is the measurement the chief operating decision-maker uses in managing
the enterprise.
−Removed: Company’s consolidated revenue of $ 513,000 and inventor royalties, contingent legal fees, litigation and licensing expense of $ 385,000
−Removed: for the nine months ended July 31, 2021 were solely related to our encrypted audio/video conference calling technology, which is included
−Removed: in our Other segment.
−Removed: All our revenue is generated domestically (United States) based on the country in which the licensee is located.
+Added: SUBSEQUENT EVENT
+Added: On March 9, 2023, we
+Added: paused further development of our COVID-19 anti-viral therapeutic program.
+Added: While our compounds have shown promise in head-to-head in
+Added: vitro analysis against Pfizer’s authorized oral treatment, results of additional animal studies indicate that there is not
+Added: sufficient oral bioavailability, and it is unclear whether an orally delivered treatment may be developed.
+Added: not currently believe that there is a viable market for an injectable treatment given the current oral treatments available.
+Added: Furthermore, we believe the needed additional investment in research for alternative delivery methods would divert resources from
+Added: more promising projects.
+Added: We continue to prosecute our U.S.
+Added: patent applications of this technology and may decide to restart
+Added: development at some time in the future.
Compared sentence by sentence after normalising whitespace, quotation marks, case and digits, so re-formatting and restated figures do not read as changed language. Wording changes appear as one removal and one addition. The current filing and the prior one are authoritative.