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 January 31, 20182024

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 0-11254001-37492

ITUS CorporationANIXA BIOSCIENCES, INC.

(Exact name of registrant as specified in its charter)

Delaware11-2622630
(State or other jurisdiction of(I.R.S. Employer
incorporation or organization)Identification No.)

3150 Almaden Expressway, Suite 250
San Jose, CA95118
(Address of principal executive offices)(Zip Code)

            Delaware                                               11-2622630      (408)708-9808

(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'sRegistrant’s telephone number, including area code)

Securities registered pursuant to Section 12(b) of the Act:

Title of each classTrading symbolName of exchange on which registered
Common Stock, par value $.01 per shareANIXNASDAQ Capital Market

Indicate by check mark whether the registrant: (1) has filed all reports required to be filed by Section 13 or 15(d) of the Securities Exchange Act of 1934 during the preceding 12 months (or for such shorter period that the registrant was required to file such reports), and (2) has been subject to such filing requirements for the past 90 days.               Yes   X                   No ___

YesNo ☐

Indicate by check mark whether the registrant has submitted electronically and posted on its corporate Web site, if any, every Interactive Data File required to be submitted and posted 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 and post such files).                Yes   X                   No ___

YesNo ☐

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   [   ]  (Do not check if a smaller reporting company)

Smaller reporting company [X]

Emerging growth company [   ]

If an emerging growth company, indicate by check mark if the registrant has elected not to use the extended transition period for complying with any new or revised financial accounting standards provided pursuant to Section 13(a) of the Exchange Act. [   ]

Indicate by check mark whether the registrant is a shell company (as defined in Rule 12b-2 of the Exchange Act).               Yes ____      No   X

Yes ☐No

Indicate the number of shares outstanding of each of the issuer'sissuer’s classes of common stock, as of the latest practicable date.

On March 5, 2018,12, 2024 the registrant had outstanding 16,631,19131,899,800 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

20
TABLE OF CONTENTSItem 1. Financial Statements.

1

PART I.  FINANCIAL INFORMATION

Item 1.

Financial Statements.

Condensed Consolidated Balance Sheets (Unaudited) as of January 31, 2018 (Unaudited)2024 and October 31, 20172023

3

1

Condensed Consolidated Statements of Operations (Unaudited) for the three months ended January 31, 20182024 and 20172023

4

2

Condensed Consolidated StatementStatements of Shareholders’ Equity (Unaudited) for the three months ended January 31, 20182024 and 2023

5

3

Condensed Consolidated Statements of Cash Flows (Unaudited) for the three months ended January 31, 20182024 and 20172023

6

4

Notes to Condensed Consolidated Financial Statements (Unaudited)

7

5

Item 2.

Management's Management’s Discussion and Analysis of Financial Condition and Results of OperationsOperations.

18

15

Item 3.

Quantitative and Qualitative Disclosures About Market Risk.

23

18

Item 4.

Controls and Procedures.

23

18

PART II. OTHER INFORMATION

19

Item 1.

Legal Proceedings.

25

Item 1. Legal Proceedings.19

Item 1A.

Risk Factors.

25

Item 1A. Risk Factors.19

Item 2.

Unregistered Sales of Equity Securities and Use of Proceeds.

25

19

Item 3.

Defaults Upon Senior Securities.

25

19

Item 4.

Mine Safety Disclosures.

25

19

Item 5.

Other Information.

25

19

Item 6. Exhibits

Exhibits.

25

19

SIGNATURES

26

ii

2


Table of Contents

PART I. FINANCIAL INFORMATION

Item 1. Financial Statements.

ITUS CORPORATION AND SUBSIDIARIES

CONDENSED CONSOLIDATED BALANCE SHEETS

(Unaudited)

January 31,

2018

October 31,

2017

ASSETS

Current assets:

 

 

 

 

 

Cash and cash equivalents

$

2,846,863

$

3,339,374

Short-term investments in certificates of deposit

 

2,650,000

 

 

3,500,000

Prepaid expenses and other current assets

 

278,496

 

174,566

Total current assets

 

5,775,359

 

 

7,013,940

Patents, net of accumulated amortization of $1,371,660 and $1,290,336,

   respectively

 

1,664,451

 

 

1,745,775

Property and equipment, net of accumulated depreciation of $39,756 and $35,725,

   respectively

 

50,828

 

52,701

Total assets

$

7,490,638

 

$

8,812,416

LIABILITIES AND SHAREHOLDERS' EQUITY

 

 

 

 

Current liabilities:

Accounts payable

$

416,925

 

$

480,324

Accrued expenses

 

669,633

 

409,169

Total current liabilities

 

1,086,558

 

 

889,493

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

-

-

Common stock, par value $.01 per share; 24,000,000 shares authorized;
  16,631,191 and 16,602,759 shares issued and outstanding, respectively

 

166,312

 

 

166,028

Additional paid-in capital

164,281,744

163,931,079

Accumulated deficit

 

(158,012,256)

 

 

(156,174,184)

Total shareholders’ equity

6,435,800

7,922,923

Noncontrolling interest (Note 1)

 

(31,720)

 

 

-

Total equity

 

6,404,080

 

7,922,923

 

 

 

 

 

 

Total liabilities and equity

$

7,490,638

$

8,812,416

The accompanying notes are an integral part of these condensed consolidated financial statements.

3


Table of Contents

ITUS CORPORATION AND SUBSIDIARIES

CONDENSED CONSOLIDATED STATEMENTS OF OPERATIONS (UNAUDITED)

For the Three Months Ended

January 31,

2018

2017

Revenue

$

-

 

$

-

Operating costs and expenses:

 

 

 

 

 

Inventor royalties, contingent legal fees and litigation and licensing
  expenses related to patent assertion

25,353

2,121

Amortization of patents

 

81,324

 

 

81,324

Research and development expenses (including non-cash stock option
  compensation expense of $40,057 and $79,700, respectively)

777,873

451,630

General and administrative expenses (including non-cash stock
  option compensation expense of $226,916 and $180,037 respectively)

 

990,036

 

 

859,885

Total operating costs and expenses

 

1,874,586

 

1,394,960

 

 

 

 

 

 

Loss from operations

(1,874,586)

(1,394,960)

 

 

 

 

 

 

Interest expense

-

(195,299)

 

 

 

 

 

 

Interest income 

 

9,112

 

999

 

 

 

 

 

 

Loss before income taxes

(1,865,474)

(1,589,260)

 

 

 

 

 

 

Provision for income taxes

 

-

 

-

 

 

 

 

 

    

Net loss

(1,865,474)

(1,589,260)

 

 

 

 

 

                   

Less: Net loss attributable to noncontrolling interest

(27,402)

-

 

 

 

 

 

 

Net loss attributable to common shareholders before deemed dividend

(1,838,072)

(1,589,260)

 

 

 

 

 

 

Deemed dividend to preferred shareholder (Note 6)

 

-

 

(2,008,775)

 

 

 

 

 

 

Net loss attributable to common shareholders

$

(1,838,072)

$

(3,598,035)

 

 

 

 

 

 

Net loss per share attributable to common shareholders:

Basic and diluted

$

(0.11)

 

$

(0.41)

Weighted average common shares outstanding:

 

 

 

 

 

Basic and diluted

 

16,610,770

 

8,755,057

The accompanying notes are an integral part of these condensed consolidated financial statements.


4


Table of Contents

ITUS CORPORATION AND SUBSIDIARIES

CONDENSED CONSOLIDATED STATEMENT OF SHAREHOLDERS’ EQUITY

FOR THE THREE MONTHS ENDED JANUARY 31, 2018 (UNAUDITED)

Additional

Paid-in

Capital

Total

Shareholders’

Equity

Non-

controlling

Interest

Common Stock

Accumulated

Deficit

Total

Equity

Shares

Par Value

Balance, October 31, 2017

16,602,759

 

$

166,028

 

$

163,931,079

 

$

(156,174,184)

 

$

7,922,923

 

$

-

 

$

7,922,923

Stock option compensation to employees and
  directors

-

 

 

-

 

 

214,427

 

 

-

 

 

214,427

 

 

-

 

 

214,427

Stock option compensation to consultants

-

 

 

-

 

 

52,546

 

 

-

 

 

52,546

 

 

-

 

 

52,546

Common stock issued upon exercise of stock
  options

23,085

 

 

231

 

 

(231)

 

 

-

 

 

-

 

 

-

 

 

-

Common stock issued to consultants

5,347

 

 

53

 

 

14,949

 

 

-

 

 

15,002

 

 

-

 

 

15,002

Issuance of noncontrolling interest in Certainty
  Therapeutics, Inc

-

 

 

-

 

 

68,974

 

 

-

 

 

68,974

 

 

(4,318)

 

 

64,656

Net loss

-

 

 

-

 

 

-

 

 

(1,838,072)

 

 

(1,838,072)

 

 

(27,402)

 

 

(1,865,474)

Balance, January 31, 2018

16,631,191

 

$

166,312

 

$

164,281,744

 

$

(158,012,256)

 

$

6,435,800

 

$

(31,720)

 

$

6,404,080

The accompanying notes are an integral part of these condensed consolidated financial statements.


5


Table of Contents

ITUS CORPORATION AND SUBSIDIARIES

CONDENSED CONSOLIDATED STATEMENTS OF CASH FLOWS (UNAUDITED)

For the three months ended

January 31,

2018

2017

Reconciliation of net loss to net cash used in operating activities:

 

 

 

 

 

Net loss

$

(1,865,474)

$

(1,589,260)

Stock option compensation to employees and directors

 

214,427

 

 

259,737

Stock option compensation to consultants

52,546

                 -

Common stock issued to consultants

 

15,002

 

 

17,811

Depreciation of property and equipment

4,391

10,505

Amortization of patents

 

81,324

 

 

81,324

Accretion of interest on patent acquisition obligations to interest expense

-

141,299

Issuance of noncontrolling interest in Certainty Therapeutics, Inc. expensed

 as a license fee

 

64,656

 

 

-

Change in operating assets and liabilities:

Prepaid expenses and other current assets

 

(103,930)

 

 

93,480

Accounts payable

(63,399)

167,453

Accrued expenses

 

260,464

 

 

87,738

Net cash used in operating activities

 

(1,339,993)

 

(729,913)

 

 

 

 

 

 

Cash flows from investing activities:

Disbursements to acquire short-term investments in certificates of deposit                                                             

(1,250,000)

 

 

-

Proceeds from maturities of short-term investments in certificates of deposit             

2,100,000

150,000

Purchase of property and equipment

 

(2,518)

 

 

(14,121)

Net cash provided by investing activities

 

847,482

 

135,879

 

 

 

 

 

 

Cash flows from financing activities:

Redemption of convertible preferred stock

 

-

 

 

(500,000)

Proceeds from exercise of employee stock options

 

-

 

5,665

Net cash used in by financing activities

 

-

 

 

(494,335)

Net decrease in cash and cash equivalents

 

(492,511)

 

 

(1,088,369)

Cash and cash equivalents at beginning of period

 

3,339,374

 

2,488,323

Cash and cash equivalents at end of period

$

2,846,863

 

$

1,399,954

Supplemental disclosure of non-cash financing activities:

 

 

 

 

 

Redemption of Series A convertible preferred stock into secured
  debenture (Note 6)

$

-

 

$

(3,000,000)

 

 

The accompanying notes are an integral part of these statements.

6


Table of Contents


ITUS CORPORATIONANIXA BIOSCIENCES, INC. AND SUBSIDIARIES

CONDENSED CONSOLIDATED BALANCE SHEETS (UNAUDITED)

(in thousands, except share and per share data)

  January 31, 2024  October 31, 2023 
ASSETS        
Current assets:        
Cash and cash equivalents $998  $915 
Short-term investments  22,800   22,929 
Receivables  391   270 
Prepaid expenses and other current assets  1,030   1,242 
Total current assets  25,219   25,356 
         
Operating lease right-of-use asset  153   166 
Total assets $25,372  $25,522 
         
LIABILITIES AND EQUITY        
Current liabilities:        
Accounts payable $364  $206 
Accrued expenses  1,242   1,770 
Operating lease liability  54   52 
Total current liabilities  1,660   2,028 
         
Operating lease liability, non-current  108   123 
Total liabilities  1,768   2,151 
         
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; 31,754,375 and 31,145,219 shares issued and outstanding as of January 31, 2024 and October 31, 2023, respectively  318   311 
Additional paid-in capital  255,738   252,222 
Accumulated deficit  (231,451)  (228,196)
Total shareholders’ equity  24,605   24,337 
Noncontrolling interest (Note 2)  (1,001)  (966)
Total equity  23,604   23,371 
Total liabilities and equity $25,372  $25,522 

The accompanying notes are an integral part of these condensed consolidated financial statements.

1

ANIXA BIOSCIENCES, INC. AND SUBSIDIARIES

CONDENSED CONSOLIDATED STATEMENTS OF OPERATIONS (UNAUDITED)

(in thousands, except per share data)

  2024  2023 
  For the Three Months Ended
January 31,
 
  2024  2023 
       
Revenue $-  $- 
         
Operating costs and expenses:        
Research and development expenses (including non-cash share-based compensation expenses of $489 and $505, respectively)  1,349   1,068 
General and administrative expenses (including non-cash share-based compensation expenses of $771 and $558, respectively)  2,260   1,488 
Total operating costs and expenses  3,609   2,556 
         
Loss from operations  (3,609)  (2,556)
         
Interest income  319   202 
         
Net loss  (3,290)  (2,354)
         
Less: Net loss attributable to noncontrolling interest  (35)  (32)
         
Net loss attributable to common shareholders $(3,255) $(2,322)
         
Net loss per common share attributable to common shareholders:        
Basic and diluted $(0.10) $(0.08)
         
Weighted average common shares outstanding:        
Basic and diluted  31,446   30,921 

The accompanying notes are an integral part of these condensed consolidated financial statements.

2

ANIXA BIOSCIENCES, INC. AND SUBSIDIARIES

CONDENSED CONSOLIDATED STATEMENTS OF EQUITY

(in thousands, except share data)

FOR THE THREE MONTHS ENDED JANUARY 31, 2024 (UNAUDITED)

  Shares  Par
Value
  Paid-in
Capital
  Accumulated
Deficit
  Shareholders’
Equity
  controlling
Interest
  Total
Equity
 
  Common Stock  Additional     Total  Non-    
  Shares  Par
Value
  Paid-in
Capital
  Accumulated
Deficit
  Shareholders’
Equity
  controlling
Interest
  Total
Equity
 
                      
Balance, October 31, 2023  31,145,219  $311  $252,222  $(228,196) $24,337  $(966) $23,371 
Stock option compensation to employees and directors  -   -   1,108   -   1,108   -   1,108 
Stock options issued to consultants  -   -   56   -   56   -   56 
Common stock issued to consultants  29,336   1   95   -   96   -   96 
Common stock issued in an at-the-market offering, net of offering expenses of $68  555,820   6   2,190   -   2,196   -   2,196 
Common stock issued upon exercise of stock options  24,000   -   67   -   67   -   67 
Net loss  -   -   -   (3,255)  (3,255)  (35)  (3,290)
                             
Balance, January 31, 2024  31,754,375  $318  $255,738  $(231,451) $24,605  $(1,001) $23,604 

FOR THE THREE MONTHS ENDED JANUARY 31, 2023 (UNAUDITED)

  Common Stock  Additional     Total  Non-    
  Shares  Par
Value
  Paid-in
Capital
  Accumulated
Deficit
  Shareholders’
Equity
  controlling
Interest
  Total
Equity
 
                      
Balance, October 31, 2022  30,913,902  $309  $247,123  $(218,385) $29,047  $(847) $28,200 
Balance  30,913,902  $309  $247,123  $(218,385) $29,047  $(847) $28,200 
Stock option compensation to employees and directors  -   -   957   -   957   -   957 
Stock options issued to consultants  -   -   81   -   81   -   81 
Common stock issued to consultants  7,364   -   25   -   25   -   25 
Common stock issued upon exercise of stock options  1,564   -   3   -   3   -   3 
Net loss  -   -   -   (2,322)  (2,322)  (32)  (2,354)
                             
Balance, January 31, 2023  30,922,830  $309  $248,189  $(220,707) $27,791  $(879) $26,912 
Balance 30,922,830  $309  $248,189  $(220,707) $27,791  $(879) $26,912 

The accompanying notes are an integral part of these condensed consolidated financial statements.

3

ANIXA BIOSCIENCES, INC. AND SUBSIDIARIES

CONDENSED CONSOLIDATED STATEMENTS OF CASH FLOWS (UNAUDITED)

(in thousands)

  2024  2023 
  For the three months ended
January 31,
 
  2024  2023 
Cash flows from operating activities:        
Reconciliation of net loss to net cash used in operating activities:        
Net loss $(3,290) $(2,354)
Stock option compensation to employees and directors  1,108   957 
Stock options issued to consultants  56   81 
Common stock issued to consultants  96   25 
Amortization of operating lease right-to-use asset  13   11 
Change in operating assets and liabilities:        
Receivables  (121)  (100)
Prepaid expenses and other current assets  212   210 
Accounts payable  158   (155)
Accrued expenses  (528)  (651)
Operating lease liability  (13)  (12)
Net cash used in operating activities  (2,309)  (1,988)
         
Cash flows from investing activities:        
Disbursements to acquire short-term investments  (20,020)  (7,835)
Proceeds from maturities of short-term investments  20,149   7,250 
Net cash provided by (used in) investing activities  129   (585)
         
Cash flows from financing activities:        
Net proceeds from sale of common stock in an at-the-market offering  2,196   - 
Proceeds from exercise of stock options  67   3 
Net cash provided by financing activities  2,263   3 
         
Net increase (decrease) in cash and cash equivalents  83   (2,570)
Cash and cash equivalents at beginning of period  915   12,360 
Cash and cash equivalents at end of period $998  $9,790 

The accompanying notes are an integral part of these condensed consolidated financial statements.

4

ANIXA BIOSCIENCES, INC. AND SUBSIDIARIES

NOTES TO CONDENSED CONSOLIDATED FINANCIAL STATEMENTS

(UNAUDITED)

(UNAUDITED)

1. BUSINESS AND FUNDING

Description of Business

As used herein, “we,” “us,” “our,” the “Company” or “ITUS”“Anixa” means ITUS CorporationAnixa Biosciences, Inc. and its wholly-owned subsidiaries.  From inception through October 2012, our primary operations involvedconsolidated subsidiaries unless otherwise indicated.

Anixa Biosciences, Inc. is a biotechnology company developing vaccines and therapies that are focused on critical unmet needs in oncology. Our vaccine programs include (i) the development of patented technologies ina preventative vaccine against triple negative breast cancer (“TNBC”), the areasmost lethal form of thin-film displaysbreast cancer, as well other forms of breast cancer and encryption.  Commencing in October 2012 the primary operations of the Company involved(ii) the development acquisition, licensing,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 enforcement(ii) until March 2023, the development of patented technologies that were eitheranti-viral drug candidates for the treatment of Covid-19.

We hold an exclusive worldwide, royalty-bearing license to use certain intellectual property owned or controlled by the Company.

In JuneThe Cleveland Clinic Foundation (“Cleveland Clinic”) relating to certain breast cancer vaccine technology developed at Cleveland Clinic. The license agreement requires us to make certain cash payments to Cleveland Clinic upon achievement of 2015, the Company announced the formation of a new subsidiary, Anixa Diagnostics Corporation (“Anixa”),specific development milestones. Utilizing this technology, we are working in collaboration with Cleveland Clinic to develop a platformmethod to vaccinate women against contracting breast cancer, focused initially on TNBC. The focus of this vaccine is a specific protein, α-lactalbumin, that is only expressed during lactation in a healthy woman’s mammary tissue. This protein disappears when the woman is no longer lactating, but reappears in many forms of breast cancer, especially TNBC. Studies have shown that vaccinating against this protein prevents breast cancer in mice.

In October 2021, following the U.S. Food and Drug Administration’s (“FDA”) authorization to proceed, 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 to Cleveland Clinic, 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 non-invasive blood testsearly-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 January 2023, the number of participants in each dose cohort was expanded, and as of August 2023, we had completed vaccinating all patients in these expanded cohorts. In December 2023, we presented the immunological data collected to date at the San Antonio Breast Cancer Symposium. 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. We have begun vaccinating participants in up to three additional dose cohorts at dose levels higher than the currently determined MTD and lower than the highest dose where we observed dose limiting side effects. Further, we have commenced vaccination of participants in the second segment of the trial, Phase 1b, that includes participants who have never had cancer, but carry certain mutations in genes such as BRCA1, BRCA2 or PALB2, that indicate a greater risk of developing TNBC in the future, and have elected to have a prophylactic mastectomy. Finally, we have commenced vaccination of participants in the third segment of the trial, Phase 1c, that includes post-operative TNBC patients that have residual disease following treatment and 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. The license agreement requires us to make certain cash payments to Cleveland Clinic upon achievement of specific development milestones. This technology pertains to among other things, the use of vaccines for the early detectiontreatment or prevention of cancer.  That platform is called CchekÔ ovarian cancers which express the anti-Mullerian hormone receptor 2 protein containing an extracellular domain (“AMHR2-ED”). In Julyhealthy tissue, this protein regulates growth and development of 2015, ITUS announcedegg-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 collaborativevaccine targeting AMHR2-ED could prevent the occurrence of ovarian cancer.

5

In May 2021, Cleveland Clinic was granted acceptance for our ovarian cancer vaccine technology into 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 agreementand development, manufacturing and Investigational New Drug (“IND”) application 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 payment of any future consideration by the Company to NCI.

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 National Cancer InstituteNCI designated cancer research center, for the purpose of validating our cancer detection methodologies and establishing protocols for identifying certain biomarkers in the blood which we identified and which are known to be associated with malignancies.  In August of 2016 and again in August of 2017, ITUS announced the renewal and expansion of our relationship with Wistar.

From October of 2015 through January of 2017, ITUS announced that we had demonstrated the efficacy of our CchekÔ early cancer detection platform with 15 different types of cancer, including:  breast, lung, colon, melanoma, ovarian, liver, thyroid, pancreatic, appendiceal, uterine, osteosarcoma, leiomyosarcoma, liposarcoma, vulvar and prostate.  Breast, lung, colon and prostate cancers represent the four largest categories of cancer worldwide.

In November of 2017, the Company announced the formation of a new subsidiary, Certainty Therapeutics, Inc. (“Certainty”), to develop immuno-therapy drugs against cancer.  Certainty entered into a license agreement with Wistar pursuant to which Certainty was granted an exclusive worldwide, royalty-bearing license to use certain intellectual property owned or controlled by Wistar relating to Wistar’s chimeric endocrine receptor targeted therapy technology (such technology being akin to chimeric antigen receptor T-cell (“CAR-T”) technology).technology. We plan tohave initially focusfocused on the development of a treatment for ovarian cancer, but we also may pursue future 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.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%(5%) of the common stock of Certainty.  Certainty, such equity stake subject to dilution by further funding of Certainty’s activities by the Company. Due to such Company funding, Wistar’s equity stake in Certainty was 4.6% as of January 31, 2024.

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Table of Contents

On November 20, 2017, we announced that Certainty, entered into ain collaboration agreement with the H. Lee Moffitt Cancer Center and Research Institute, Inc. (“Moffitt”) to advance toward, has begun human clinical testing of the CAR-T technology licensed by Certainty from Wistar aimed initially at treating ovarian cancer. Certainty intendsAfter receiving authorization from the FDA, we commenced enrollment of patients in a Phase 1 clinical trial and treated the first patient in August 2022. 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 was well-tolerated by the patients. In February 2024, we treated the first patient in the second dose cohort, where the patient was administered a three-times higher dose of cells than the patients in the first cohort. The treatment appears to workhave been well-tolerated by the patient. This study is a dose-escalation trial with researcherstwo arms based on route of delivery—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 complete studies necessary48 patients who have received at least two prior lines of chemotherapy. The study is estimated to submit an Investigational New Drug (“IND”) application withbe completed in two to four years depending on multiple factors including when maximum tolerated dose is reached, the U.S. Food and Drug Administration (“FDA”).

On January 29, 2018, we announced the results of a study augmenting data from our preliminary study released in December 2016. The majorityrate of patient samples collected for this study were from breast cancerenrollment, and prostate cancer patients, but several other types were also included. Withhow long we maintain the additional cancers included in this study, we have now demonstrated our technology with 20 types of cancer from solid tumors. In addition to the 15 cancer types noted above, we have evaluated bladder, cervical, head and neck, gastric and testicular cancers.two different delivery methods.

Over the next several quarters, we expect Cchek™the development of our vaccines and Certainty’s ovarian cancer treatmenttherapeutics to be the primary focus of the Company. As part of our legacy operations, the Company remains engaged in limited patent licensing activities in the area of encrypted audio/video conference calling.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 quarters,years, our revenue was derived from technology licensing and the sale of patented technologies, including revenue from the settlement of litigation. We have not generated any revenue to date from our vaccine or therapeutics programs. In addition, to Anixawhile we pursue our vaccine and Certainty, the Companytherapeutics 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.

6

Funding and Management’s Plans

During the three months ended January 31, 2018, cash used in operating activities was approximately $1,340,000.  Net cash provided by investing activities was approximately $847,000, which reflects the purchase of certificates of deposit totaling $1,250,000, offset by proceeds from the sale or maturity of certificates of deposit totaling $2,100,000 and the purchase of property and equipment of approximately $3,000.  As a result, our cash, cash equivalents and short-term investments at January 31, 2018 decreased by approximately $1,342,000 to approximately $5,497,000 from approximately $6,839,000 at the end of fiscal year 2017.

Based on currently available information as of March 8, 2018,12, 2024, 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 12twelve 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 complimentarycomplementary to our technologies, we may be required to obtain more working capital. During the three months ended January 31, 2024, we raised approximately $2,196,000, net of expenses, through an at-the-market equity offering of 555,820 shares of common stock, under which offering we may issue up to $100 million of common stock. Under our at-the-market equity program, which is currently effective and may remain available for us to use in the future, as of January 31, 2024, we may sell an additional approximately $98 million of common stock. We may seek to obtain working capital during our fiscal year ending 20182024 or thereafter through sales of our equity securities or through bank credit facilities or public or private debt from various financial institutions where possible. We cannot be certain that additional funding will be available on acceptable terms, or at all. If we do identify sources for additional funding, the sale of additional equity securities or convertible debt couldwill result in dilution to our shareholders.  Additionally, the sale of equity securities or issuance of debt securities may be subject to certain security holder approvals or may result in the downward adjustment of the exercise or conversion price of our outstanding securities.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

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Table of Contents

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, 2017.2023. The accompanying October 31, 20172023 condensed consolidated balance sheet data was derived from the audited financial statements but does not include all disclosures required by accounting principles generally accepted in the United States of America (“US GAAP”).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 January 31, 2018,2024, and results of operations and cash flows for the interim periods represented. The results of operations for the three months ended January 31, 20182024 are not necessarily indicative of the results to be expected for the entire 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 three months ended January 31, 2018:2024 (in thousands):

SCHEDULE OF CHANGES IN NONCONTROLLING INTEREST

Balance October 31, 2017

$

0

Issuance of noncontrolling interest in Certainty

 

(4,318)

Net loss attributable to noncontrolling interest

(27,402)

Balance January 31, 2018

$

(31,720)

Balance, October 31, 2023 $(966)
Net loss attributable to noncontrolling interest  (35)
Balance, January 31, 2024 $(1,001)

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Table of Contents

Revenue Recognition

Our revenue has been derived solely from technology licensing and the sale of patented technologies. Revenue is recognized when (i) persuasive evidenceupon transfer of control of intellectual property rights and satisfaction of other contractual performance obligations to licensees in an arrangement exists, (ii) allamount 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 have been substantially performed pursuant to transfer goods and services, identifying the termsperformance obligations in the contract, determining the transaction price and allocating the transaction price to separate performance obligations, estimating the timing of the arrangement, (iii) amounts are fixedsatisfaction of performance obligations, determining whether a promise to grant a license is distinct from other promised goods or determinable,services and (iv) the collectability of amounts is reasonably assured.evaluating whether a license transfers to a customer at a point in time or over time.

7

Patent Licensing Revenue

In certain instances, our pastOur revenue arrangements have providedprovide 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 hadhave no further obligations.   As such,obligations with respect to the earnings process was complete and revenue has been recognizedgranted 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 the execution of the agreement, when collectability was reasonably assured,agreement. Accordingly, the performance obligations from these arrangements are satisfied and when all other revenue recognition criteria were met.100% of the revenues are recognized upon execution of the agreements.

Intangible AssetsCost of Revenues

Our only identifiable intangible assets are patents and patent rights.  We capitalize patent and patent rights acquisitionCost of revenues include the costs and amortizeexpenses 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 consist primarily of employee compensation, payments to third parties for research and development activities and other direct costs associated with developing our therapeutics and vaccines. We recognize research and development expenses as incurred. Advance payments for future research and development activities are deferred and expensed as the services are performed. We recognize our preclinical studies and clinical trial expenses based on the services performed pursuant to contracts with research institutions, clinical research organizations (“CROs”), clinical manufacturing organizations (“CMOs”), and other parties that conduct and manage various stages of research and development activities on our behalf. Fees for such services are recognized based on management’s estimates after considering the activities and tasks completed by each service provider in a given period, the time period over which services are expected to be performed, and the level of effort expended in each reporting period.

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, over the estimated economic useful life.  We did not capitalizenet of any patent acquisition costs during the three months ended January 31, 2018applicable discount which is amortized to interest income, and 2017.  We recorded patent amortization expense of approximately $81,000 during each of the three-month periods ended January 31, 2018 and 2017, respectively.are accounted for as held-to-maturity securities.

2.         3. STOCK BASED COMPENSATION

The Company maintains stock equity incentive plans under which the Company grantsmay grant 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

TheWe account for stock options granted to employees, directors and consultants using the accounting guidance in ASC 718, Stock Compensation (“ASC 718”). We estimate the fair value of service-based stock options on the date of grant, using the Black-Scholes pricing model, and recognize compensation cost forexpense over the requisite service basedperiod of the grant. We recorded stock-based compensation expense related to service-based stock options granted to employees and directors of approximately $1,108,000 and $957,000 during the three months ended January 31, 2024 and 2023.

8

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 recognized as an expenseexpensed on a straight-line basis over the requisite service period (the vesting period of the stock option) which is one to tenthree years. We recorded stock-based compensation expense related to stock options granted to employees and directors of approximately $214,000 and $260,000 during the three months ended January 31, 2018 and 2017, respectively.

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Table of Contents

For service based stock options granted to consultants we estimate the fair value of the stock options and recognize expense at each reporting period using the Black-Scholes pricing model.  We recorded stock-based compensationconsulting expense related to stock options granted to consultants of approximately $53,000$56,000 and $-0-$81,000 during the three months ended January 31, 20182024 and 2017,2023, respectively.

Stock Option ActivityPlans

During the three months ended January 31, 2024, we had two stock option plans: the Anixa Biosciences, Inc. 2010 Share Incentive Plan (the “2010 Share Plan”) and the Anixa Biosciences, Inc. 2018 Share Incentive Plan (the “2018 Share Plan”), which were adopted by our Board of Directors on July 14, 2010 and 2017,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 January 31, 2024 and 2023, we granted options to purchase 50,0001,335,000 shares and 106,0001,505,000 shares of common stock, respectively, to employees directors and consultants, at weighted averagewith exercise prices of $2.30 and $5.00ranging from $4.19 to $4.81 per share, respectively, pursuant to the ITUS Corporation 20102018 Share Incentive Plan (the "2010 Share Plan”).Plan. During the three months ended January 31, 20182024 and 2017,2023, stock options to purchase 28,60024,000 and 2,2001,261 shares of common stock, respectively, were exercised on a cash basis, with aggregate proceeds of approximately $-0-$67,000 and $6,000,$3,000, respectively. Under certain circumstances,During the three months ended January 31, 2023, stock options may beto purchase 1,111 shares of common stock, of which 808 shares were withheld, were exercised on a cashless basis. During the three months ended January 31, 2018 and 2017, 5,515 and -0- shares of common2024, no stock respectively,options were withheld in connection withexercised on a cashless exercises of stock options.basis.

Stock Option Plans

As of January 31, 2018, we have two stock option plans:  the ITUS Corporation 2003 Share Incentive Plan (the "2003 Share Plan") and the 2010 Share Plan which were adopted by our Board of Directors on April 21, 2003 and July 14,

The 2010 respectively. 

The 2003 Share Plan provided for the grant of nonqualified stock options, stock appreciation rights, stock awards, performance awards and stock units to employees, directors and consultants. In accordance with the provisions of the 20032010 Share Plan, the plan terminated with respect to the ability to grant future optionsawards on April 21, 2013.July 14, 2020. Information regarding the 20032010 Share Plan for the three months ended January 31, 20182024 is as follows:

 

 

 

 Weighted

Average Exercise

 Price Per Share

 

 

 

 

 

 

Aggregate

Intrinsic

Value

 

 

 

 

 

Shares

 

 

Options Outstanding at October 31, 2017

30,600

 

$

3.16

 

 

 

Exercised

(10,600)

 

$

0.67

 

 

 

Forfeited

(5,600)

 

$

3.63

 

 

 

Options Outstanding and exercisable at

    January 31, 2018

14,400

 

$

4.81

 

$

17,280

SCHEDULE OF OPTION ACTIVITY

  Shares  Weighted
Average Exercise
Price Per Share
  Aggregate
Intrinsic Value
(in thousands)
 
Options outstanding at October 31, 2023  1,189,000  $2.94     
Exercised  (13,000)  2.92     
Options outstanding and exercisable at January 31, 2024  1,176,000  $2.94  $2,012 

The following table summarizes information about stock options outstanding and exercisable under the 20032010 Share Plan as of January 31, 2018:2024:

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   366,000   3.3  $1.27 
$2.58 - $3.13   301,000   2.0  $2.91 
$3.46 - $5.30   509,000   4.3  $4.17 

Number

Outstanding

and

Exercisable

Weighted Average

Remaining

Contractual Life

(in years)

 

 

 

 

 

Weighted

Average

Exercise Price

Range of

Exercise Prices

 

 

 

 

  $ 0.67 - $17.50

14,400

1.31

 

$

4.81

9

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Table of Contents2018 Share Plan

The 20102018 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 January 31, 2018,2024, the 20102018 Share Plan had 802,450883,906 shares available for future grants. Information regarding the 20102018 Share Plan for the three months ended January 31, 20182024 is as follows:

SCHEDULE OF OPTION ACTIVITY

 

 

 

 Weighted

Average
Exercise Price
Per Share

 

Aggregate

Intrinsic

Value

 

 

 

 

 

Shares

 

 

Options Outstanding at October 31, 2017

1,637,246

 

$

1.50

 

 

Granted

50,000

 

$

2.30

 

 

Exercised

(18,000)

 

$

0.67

 

 

Forfeited

(4,800)

 

$

3.80

 

Options Outstanding at January 31, 2018

1,664,446

 

$

1.52

 

$

3,752,696

Options Exercisable at January 31, 2018

1,013,106

 

$

1.72

 

$

2,120,876

  Shares  Weighted
Average Exercise
Price Per Share
  

Aggregate

Intrinsic Value
(in thousands)

 
Options outstanding at October 31, 2023  10,241,000  $3.67     
Granted  1,335,000  $4.39     
Exercised  (11,000) $2.68     
Forfeited/Expired  (243,906)  4.31     
Options outstanding at January 31, 2024  11,321,094  $3.74  $9,236 
Options exercisable at January 31, 2024  7,085,397  $3.51  $7,083 

The following table summarizes information about stock options outstanding and exercisable under the 20102018 Share Plan as of January 31, 2018:2024:

SCHEDULE OF OUTSTANDING AND EXERCISABLE

 

Options Outstanding

 

Options Exercisable

 

 

 

Weighted

Average

Remaining

Contractual 
Life

(in years)

 

 

 

 

Weighted

Average

Remaining

Contractual 
Life 
(in years)

 

 

 

 

 

 

 

 

 

 

Weighted

Average

Exercise 
Price

 

 

 

 

Weighted

Average

Exercise

Price

 

 

 

Range of

Exercise Prices

 

Number

Outstanding

 

 

Number

Exercisable

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

$0.67

 

983,000

7.40

$

0.67

 

556,754

6.18

$

0.67

$ 2.27 - $ 7.00

 

681,446

6.00

$

2.75

 

456,352

4.61

$

2.99

   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   5,458,879   6.2  $3.24   4,976,100   5.9  $3.28 
$3.96 - $5.30   5,862,215   8.2  $4.20   2,109,297   7.2  $4.04 

In additionEmployee Stock Purchase Plan

The Company maintains the Anixa Biosciences, Inc. Employee Stock Purchase Plan (the “ESPP”) which permits eligible employees to options granted underpurchase shares at not less than 85% of the 2003 Share Plan andmarket value of the 2010 Share Plan,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 grantthree months ended January 31, 2024 and 2023, no shares were purchased under the ESPP.

Warrants

As of stock optionsJanuary 31, 2024, we had warrants outstanding to purchase 1,780,000 shares.  300,000 shares of common stock at $6.56 per share, issued during fiscal year 2021 and expiring on March 22, 2026.

Information regarding stock options outstanding that were not granted under the 2003 Plan or the 2010 PlanCompany’s warrants for the three months ended January 31, 20182024 is as follows:

SCHEDULE OF WARRANTS ACTIVITY

  Shares  Weighted
Average Exercise
Price Per Share
  Aggregate
Intrinsic
Value
 
Warrants Outstanding at October 31, 2023  300,000  $6.56                
Warrants Outstanding and Exercisable at January 31, 2024  300,000  $6.56  $0 

 

 

 

 Weighted

Average 
Exercise

Price Per Share

 

Aggregate

Intrinsic

Value

 

 

 

 

 

Shares

 

 

Options Outstanding at October 31, 2017

1,780,000

 

$

1.58

 

 

 

Options Outstanding and exercisable at

    January 31, 2018

1,780,000

 

$

1.58

 

$

3,953,820

10

The following table summarizes information about stock optionsthe Company’s outstanding and exercisable that were not granted under the 2003 Share Plan or the 2010 Share Planwarrants as of January 31, 2018:2024:

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   2.1  $6.56 

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Table of Contents

 

 

Number

Outstanding

and

Exercisable

 

Weighted Average

Remaining

Contractual Life

(in years)

 

 

 

 

 

 

 

 

Weighted

Average

Exercise 
Price

Range of

Exercise Prices

 

 

 

 

 

 

 

 

$0.67

 

1,046,000

 

4.66

 

$

0.67

$ 2.58-$ 5.56

 

734,000

 

4.11

 

$

2.88

Stock Awards

We account for stock awards granted to employees, directors and consultants based on the grant date market price of the underlying common stock.  During the three months ended January 31, 2018 and 2017, we issued 5,347 shares and 3,463 shares, respectively, of common stock to consultants for services rendered.  We recorded consulting expense for the three months ended January 31, 2018 and 2017 of approximately $15,000 and $18,000, respectively, for the shares of common stock issued to consultants. 

3.         4. FAIR VALUE MEASUREMENTS

US GAAP defines fair value and establishes a framework for measuring fair value. We have categorized our financial assets and liabilities, based on the priority of the inputs to the valuation technique, into a three-level fair value hierarchy as set forth below. If the inputs used to measure the financial instruments fall within different levels of the hierarchy, the categorization is based on the lowest level input that is significant to the fair value measurement of the instrument.

Financial assets and liabilities recorded in the accompanying condensed consolidated balance sheets are categorized based on the inputs to the valuation techniques as follows:

Level 1 - Financial assets and liabilitiesinstruments whose values are based on unadjusted quoted prices for identical assets or liabilities in an active market which we have the ability to access at the measurement date.

Level 2 - Financial assets and liabilitiesinstruments whose values are based on quoted market prices in markets where trading occurs infrequently or whose values are based on quoted prices of instruments with similar attributes in active markets.

Level 3 – Financial assets and liabilitiesinstruments whose values are based on prices or valuation techniques that require inputs that are both unobservable and significant to the overall fair value measurement. These inputs reflect management’s own assumptions about the assumptions a market participant would use in pricing the asset and liabilities.instrument.

The following table presents the hierarchy for our financial assets measured at fair value on a recurring basis as of January 31, 2018:2024 (in thousands):

SCHEDULE OF FAIR VALUE MEASUREMENTS

  Level 1  Level 2  Level 3  Total 
Money market funds:                
Cash equivalents $855  $-  $-  $855 
U.S. treasury bills:                
Short-term investments  -   22,800   -   22,800 
Total financial assets $855  $22,800  $-  $23,655 

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Level 1

Level 2

Level 3

Total

 

 

 

 

 

      

 

 

      

 

 

 

Money market funds –

    Cash equivalents

$

2,470,624

 

$

-

 

$

-

 

$

2,470,624

Certificates of deposit –

    Short-term investments

 

-

 

 

2,650,000

 

 

-

 

 

2,650,000

Total financial assets

$

2,470,624

 

$

2,650,000

 

$

-

 

$

5,120,624

The following table presents the hierarchy for our financial assets measured at fair value on a recurring basis as of October 31, 2017:2023 (in thousands):

  Level 1  Level 2  Level 3  Total 
Money market funds:                
Cash equivalents $778  $-  $-  $778 
Money market funds Cash equivalents $778  $-  $-  $778 
Certificates of deposit:                
Short term investments  -   720   -   720 
Certificates of deposit Short term investments  -   720   -   720 
U.S. treasury bills:                
Short-term investments  -   22,209   -   22,209 
U.S. treasury bills Short-term investments  -   22,209   -   22,209 
Total financial assets $778  $22,929  $-  $23,707 

 

Level 1

Level 2

Level 3

Total

 

 

 

 

 

      

 

 

      

 

 

 

Money market funds –

    Cash equivalents

$

3,079,282

 

$

-

 

$

-

 

$

3,079,282

Certificates of deposit –

    Short term investments

 

-

 

 

3,500,000

 

 

-

 

 

3,500,000

Total financial assets

$

3,079,282

 

$

3,500,000

 

$

-

 

$

6,579,232

Our non-financial assets that are measured on a non-recurring basis include our patents andare 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. Cash and cash equivalents are stated at carrying value which approximates fair value.

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4.         SHORT-TERM INVESTMENTS

At January 31, 2018 and October 31, 2017, we had certificates of deposit of $2,650,000 and $3,500,000, respectively, which were classified as short-term investments and reported at fair value. 

5. ACCRUED EXPENSES

Accrued expenseexpenses consist of the following as of:

 

January 31,

2018

 

October 31, 2017

 

 

Accrued severance costs

 

161,475

 

 

237,563

Payroll and related expenses

 

178,916

 

 

51,643

Accrued collaborative research and license expenses

 

220,431

 

 

-

Accrued other

 

108,811

 

 

119,963

 

$

669,633

 

$

409,169

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SCHEDULE OF ACCRUED EXPENSES


  January 31,  October 31, 
  2024  2023 
  (in thousands) 
Payroll and related expenses $552  $1,114 
Accrued royalty and contingent legal fees  626   626 
Accrued other  64   30 
Accrued expenses $1,242  $1,770 

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6. PREFERRED STOCK REDEMPTION

On November 11, 2016, the holder of all our outstanding Series A Preferred Stock (the “Series A Preferred”) with an aggregate stated value of $3,500,000 exercised its right of redemption to receive such amount from proceeds from the sale of the Company’s equity securities.  On December 6, 2016, we entered into an agreement with the holder of the Series A Preferred setting forth the terms under which such redemption would take place (the “Series A Redemption Terms”).  Pursuant to the Series A Redemption Terms, on December 9, 2016 the holder of the Series A Preferred received (i) $500,000 in cash, (ii) a 12% secured debenture evidencing the remaining $3,000,000 amount to be redeemed, $1,000,000 of which was due on or before June 1, 2017 and the remainder of which was due November 11, 2017 (the “Redemption Debenture”), and (iii) a 5 year warrant to purchase 500,000 shares of the Company’s common stock at an exercise price equal to 10% below the thirty (30) day volume weighted average closing price of our common stock at closing (the “Redemption Warrant”). The Redemption Debenture was secured by a lien on the Company’s assets and prohibited the Company from incurring any senior indebtedness other than equipment financing in connection with the Company’s business.  The Redemption Debenture was paid in full during fiscal year 2017. 

The difference between the fair value of the consideration given to the holder of our Series A Preferred and the carrying value of the Series A Preferred represents a return to the preferred shareholder which is treated in a similar manner as that of dividends paid on preferred stock.  In the redemption, the Series A Preferred holder received $500,000 in cash, the Redemption Debenture with a present value of approximately $2,999,000 and the Redemption Warrant with a fair value of approximately $2,801,000, determined using the Black Scholes pricing model, and waived the Series A Preferred’s conversion right with an intrinsic value of approximately $792,000, resulting in total consideration given to the Series A Preferred holder of approximately $5,508,000.  The difference between the fair value of the consideration and the $3,500,000 carrying value of the Series A Preferred resulted in a deemed dividend to the Series A Preferred holder of approximately $2,008,000.

7.         NET INCOME (LOSS)LOSS PER SHARE OF COMMON STOCK

Basic net income (loss)loss per common share (“Basic EPS”) is computed by dividing net income (loss)loss by the weighted average number of common shares outstanding. Diluted net income (loss)loss per common share (“Diluted EPS”) is computed by dividing net income (loss)loss by the weighted average number of common shares and dilutive common share equivalents and convertible securities then outstanding. The treasury stock method reduces the dilutive effect of potentially dilutive securities as it assumes that any cash proceeds (from the issuance of potentially dilutive securities) are used to buy back shares at the average share price during the period.

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 three months ended January 31, 20182024 and 2017,2023, were stock options to purchase 3,458,84612,497,094 and 3,162,27211,821,500 shares, respectively, and warrants to purchase 829,400300,000 and 837,405300,000 shares, respectively.

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8.         7. EFFECT OF RECENTLY ADOPTED AND ISSUED PRONOUNCEMENTS

In May 2014,October 2021, the Financial Accounting Standards Board ("FASB")FASB issued Accounting Standards Update 2014-09 (“ASU 2014-09”),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. This amendment updates addressingAt the acquisition date, an acquirer should account for the related revenue from contracts in accordance with customers, which clarifies existing accounting literature relating to howTopic 606 as if it had originated the contracts. The amendments in this update should be applied prospectively and when a company recognizes revenue. Under the standard, a company will recognize revenue when it transfers promised goods or services to customers in an amount that reflects the consideration to which the company expects to be entitled in exchange for those goods and services.  This standard update isare effective for interim and annual reporting periodsfiscal years beginning after December 15, 2016, and were to be applied retrospectively or the cumulative effect as of the date of adoption, with early application not permitted.  In July 2015, a one-year deferral of the effective date of the new guidance was approved.  We do not expect the2022, including interim periods within those fiscal years. The adoption of ASU 2014-09 tothis standard did not have a material impact on our consolidated financial statements and related disclosures.

In November 2015, the FASB issued Accounting Standards Update 2015-17 (“ASU 2015-17”) to simplify the presentation of deferred taxes. This amendment requires that all deferred tax assets and liabilities, along with any related valuation allowances, be classified as noncurrent on the balance sheet.  Adoption of this standard is required for annual periods beginning after December 15, 2016.  The adoption of this amendment did not have an impact on our consolidated financial statements and related disclosures as we currently do not present deferred tax assets or liabilities.

In February 2016, the FASB issued Accounting Standards Update 2016-02 (“ASU 2016-02”) which requires lessees to recognize most leases on the balance sheet. This is expected to increase both reported assets and liabilities.  The new lease standard does not substantially change lessor accounting. For public companies, the standard will be effective for the first interim reporting period within annual periods beginning after December 15, 2018, although early adoption is permitted. Lessees and lessors will be required to apply the new standard at the beginning of the earliest period presented in the financial statements in which they first apply the new guidance, using a modified retrospective transition method.  The requirements of this standard include a significant increase in required disclosures.  We began a detailed assessment of the impact that this guidance will have on our consolidated financial statements and related disclosures, and our analysis is currently ongoing.

In March 2016, the FASB issued Accounting Standards Update 2016-09 (“ASU 2016-09”) that changes the accounting for certain aspects of share-based payments to employees.  The new guidance requires all income tax effects of awards to be recognized in the income statement when the awards vest or are settled. It also allows an employer to repurchase more of an employee’s shares than it can today for tax withholding purposes without triggering liability accounting and to make a policy election for forfeitures as they occur.  The guidance is effective for public business entities for fiscal years beginning after December 15, 2016, and interim periods within those years. We adopted ASU 2016-09 on November 1, 2017 and the adoption did not have an impact on our consolidated financial statements and related disclosures.

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In May 2017, the FASB issued Accounting Standards Update 2017-09 (“ASU 2017-09”) that provides guidance on determining which changes to the terms and conditions of share-based payment awards require an entity to apply modification accounting.  This update is effective for all entities for fiscal years beginning after December 15, 2017, and interim periods within those years.  Early adoption is permitted.  We began a detailed assessment of the impact that this guidance will have on our consolidated financial statements and related disclosures, and our analysis is ongoing.

9.         8. INCOME TAXES

We file Federal, New York, California and Pennsylvania state income tax returns.  Due to net operating losses, the statute of limitations for Federal and New York State income tax returns remains open to examination by taxing authorities since the fiscal year ended October 31, 1998.  We account for interest and penalties related to income tax matters, if any, in general and administrative expenses. There are no unrecognized income tax benefits as of January 31, 2018 and October 31, 2017.

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 substantial net operating loss carryforwards for Federal, New York State and California income tax returns. These net operating loss carryforwards could be subject to limitations under Internal Revenue Code section 382. We have 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 January 31, 2024 and October 31, 2023 and we account for interest and penalties related to income tax matters, if any, in general and administrative expenses.

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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, as amended, will expire on 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 lease, as amended, 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 January 31, 2024 and 2023.

For operating leases, the lease liability is initially and subsequently measured at the present value of the unpaid lease payments. The remaining 32-month lease term as of January 31, 2024 for the Company’s lease includes the noncancelable period of the lease and the additional two-year option period that the Company is reasonably certain to exercise. All right-of-use assets are reviewed for impairment when indications of impairment are present.

As of January 31, 2024, the annual minimum future lease payments of our operating lease liabilities were as follows (in thousands):

SCHEDULE OF MINIMUM LEASE PAYMENTS

For years Ended October 31, Operating
Leases
 
2024 $51 
2025  70 
2026  65 
Total future minimum lease payments, undiscounted  186 
Less: Imputed interest  (24)
Present value of future minimum lease payments $162 

10. COMMITMENTCOMMITMENTS AND CONTINGENCES

Litigation Matters

Other than suits we bringlawsuits related to enforcethe enforcement of our patent rights, we are not a party to any material pending legal proceedings, other thannor are we aware of any pending litigation or legal proceeding against us that which arise in the ordinary course of business.  We believe that any liability that may ultimately result from the resolution of these matters will not, individually or in the aggregate,would have a material adverse effect onupon our financial position or results of operations.operations or financial condition.

17
License Commitments

As of January 31, 2024, our commitments under certain technology license agreements related to our therapeutic and vaccine development programs for the remainder of fiscal year 2024, were approximately $14,000.

Research & Development Agreements

We have entered into certain research and development agreements with various third-party vendors related to the manufacturing and stability testing of the materials necessary for the development of our breast cancer vaccine and our CAR-T therapeutic. As of January 31, 2024, future payments the Company may make under these agreements, dependent upon, among other things, development of analytical methods, formulation feasibility studies, stability testing, and results of manufacturing processes, may be approximately $3.6 million and such payments may be made over up to a five-year period.


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11. SEGMENT INFORMATION

We follow the accounting guidance of ContentsASC 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 months ended January 31, 2024 and 2023 and as of January 31, 2024 and October 31, 2023 (in thousands):

SCHEDULE OF SEGMENT INFORMATION

  2024  2023 
  For the Three Months Ended
January 31,
 
  2024  2023 
Net loss:        
CAR-T Therapeutics $(1,525) $(911)
Cancer Vaccines  (1,756)  (958)
Anti-Viral Therapeutics  -   (482)
Other  (9)  (3)
Total $(3,290) $(2,354)
Net loss $(3,290) $(2,354)
         
Total operating costs and expenses $3,609  $2,556 
Less non-cash share-based compensation  (1,260)  (1,063)
Operating costs and expenses excluding non-cash share-based compensation $2,349  $1,493 
Operating costs and expenses excluding non-cash
share based compensation expense:
        
CAR-T Therapeutics $1,128  $598 
Cancer Vaccines  1,213   588 
Anti-Viral Therapeutics  -   305 
Other  8   2 
Total $2,349  $1,493 
Operating costs and expenses excluding non-cash share based compensation $2,349  $1,493 

  January 31,
2024
  October 31,
2023
 
Total assets:        
CAR-T Therapeutics $12,124  $7,523 
Cancer Vaccines  13,162   17,215 
Anti-Viral Therapeutics  -   700 
Other  86   84 
Total $25,372  $25,522 
Total assets $25,372  $25,522 

Operating costs and expenses excluding non-cash share-based compensation is the measurement the chief operating decision-maker uses in managing the enterprise.

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Item 2. Management'sManagement’s Discussion and Analysis of Financial Condition and Results of Operations.

GENERAL

As used herein, “we,” “us,” “our,” the “Company” or “ITUS” means ITUS Corporation and its wholly-owned subsidiaries.  From inception through October 2012, our primary operations involved the development of patented technologies in the areas of thin-film displays and encryption.  Commencing in October 2012 the primary operations of the Company involved the development, acquisition, licensing, and enforcement of patented technologies that were either owned or controlled by the Company.

In June of 2015, the Company announced the formation of a new subsidiary, Anixa Diagnostics Corporation (“Anixa”), to develop a platform for non-invasive blood tests for the early detection of cancer.  That platform is called CchekÔ .  In July of 2015, ITUS announced a collaborative research agreement with The Wistar Institute (“Wistar”), the nation’s first independent biomedical research institute and a leading National Cancer Institute designated cancer research center, for the purpose of validating our cancer detection methodologies and establishing protocols for identifying certain biomarkers in the blood which we identified and which are known to be associated with malignancies.  In August of 2016 and again in August of 2017, ITUS announced the renewal and expansion of our relationship with Wistar.

From October of 2015 through January of 2017, ITUS announced that we had demonstrated the efficacy of our CchekÔ early cancer detection platform with 15 different types of cancer, including:  breast, lung, colon, melanoma, ovarian, liver, thyroid, pancreatic, appendiceal, uterine, osteosarcoma, leiomyosarcoma, liposarcoma, vulvar and prostate.  Breast, lung, colon and prostate cancers represent the four largest categories of cancer worldwide.

In November of 2017, the Company announced the formation of a new subsidiary, Certainty Therapeutics, Inc. (“Certainty”), to develop immuno-therapy drugs against cancer.  Certainty entered into a license agreement with Wistar pursuant to which Certainty was granted an exclusive worldwide, royalty-bearing license to use certain intellectual property owned or controlled by Wistar relating to Wistar’s chimeric endocrine receptor targeted therapy technology (such technology being akin to chimeric antigen receptor T-cell (“CAR-T”) technology).  We plan to initially focus on the development of a treatment for ovarian cancer, but we also may pursue future applications of the technology for the development of treatments for additional solid tumors.  The license agreement requires Certainty to make certain cash and equity payments to Wistar.  With respect to Certainty’s equity obligations to Wistar, Certainty issued to Wistar shares of its common stock equal to five percent (5%) of the common stock of Certainty.  

On November 20, 2017, we announced that Certainty entered into a collaboration agreement with the H. Lee Moffitt Cancer Center and Research Institute, Inc. (“Moffitt”) to advance toward human clinical testing the CAR-T technology licensed by Certainty from Wistar aimed initially at treating ovarian cancer.  Certainty intends to work with researchers at Moffitt to complete studies necessary to submit an Investigational New Drug (“IND”) application with the U.S. Food and Drug Administration (“FDA”).

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On January 29, 2018, we announced the results of a study augmenting data from our preliminary study released in December 2016. The majority of patient samples collected for this study were from breast cancer and prostate cancer patients, but several other types were also included. With the additional cancers included in this study, we have now demonstrated our technology with 20 types of cancer from solid tumors. In addition to the 15 cancer types noted above, we have evaluated bladder, cervical, head and neck, gastric and testicular cancers.

Over the next several quarters, we expect Cchek™ and Certainty’s ovarian cancer treatment to be the primary focus of the Company.  As part of our legacy operations, the Company remains engaged in limited patent licensing activities in the area of encrypted audio/video conference calling.  We do not expect these activities to be a significant part of the Company’s ongoing operations nor do we expect these activities to require material financial resources or attention of senior management.

Over the past several quarters, our revenue was derived from technology licensing and the sale of patented technologies, including revenue from the settlement of litigation.  In addition to Anixa and Certainty, the Company may make investments in and form new companies to develop additional emerging technologies.

RESULTS OF OPERATIONS

Three months ended January 31, 2018 compared with three months ended January 31, 2017

Revenue

We had no revenue during the three-month periods ended January 31, 2018 and 2017.

Inventor Royalties, Contingent Legal Fees and Litigation and Licensing Expenses Related to Patent Assertion

Inventor royalties, contingent legal fees and litigation and licensing expenses related to patent assertion activities were approximately $25,000 in the three months ended January 31, 2018 compared to approximately $2,000 in the comparable prior year period due to expenses related to continuing litigation.  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. 

Amortization of Patents

Amortization of patents was approximately $81,000 in each of the three-month periods ended January 31, 2018 and 2017, respectively.  We capitalize patent and patent rights acquisition costs and amortize the cost over the estimated economic useful life. 

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Research and Development Expenses

Research and development expenses are related to the development of our early cancer detection and cancer immune-therapy drug platforms and increased by approximately $326,000 to approximately $778,000 in the three months ended January 31, 2018, from approximately $452,000 in the three months ended January 31, 2017.  The increase in research and development expenses was primarily due to an increase in costs related to our collaboration and license agreements with Wistar and the initiation of our collaboration agreement with Moffitt of approximately $363,000 and an increase in employee compensation and related costs, other than stock option expense, of approximately $42,000, offset by a decrease in employee stock option expense of approximately $40,000 and a decrease in patent development costs of approximately $26,000.

General and Administrative Expenses

General and administrative expenses increased by approximately $130,000 to approximately $990,000 in the three months ended January 31, 2018, from approximately $860,000 in the three months ended January 31, 2017. The increase in general and administrative expenses was principally due to an increase in legal and accounting fees of approximately $120,000 due primarily to potential strategic transactions, the commencement and subsequent termination of an at-the-market equity program and the special shareholder meeting scheduled for March 2018, an increase in consultant stock option expense of approximately $53,000 and an increase in consultant fees of approximately $22,000, offset by a decrease in employee compensation of approximately $70,000.

Interest Expense

Interest expense decreased from approximately $195,000 in the three months ended January 31, 2017 to $-0- in the current period due to the payment in full of the patent acquisition obligation and the secured debenture during fiscal year 2017.

Interest Income

Interest income increased by approximately $8,000 to approximately $9,000 in the three months ended January 31, 2018, from approximately $1,000 in the comparable prior year period as a result of additional cash on hand.

Net Loss Attributable to Noncontrolling Interest

The net loss attributable to noncontrolling interest of approximately $27,000 in the three months ended January 31, 2018 represents Wistar’s 5% ownership interest in Certainty’s net loss for the three-month period.

Deemed Dividend to Preferred Shareholder

The deemed dividend to preferred shareholder of approximately $2,009,000 in 2017 resulted from the redemption of our Series A Preferred.  The difference between the fair value of the consideration given to the holder of our Series A Preferred and the carrying value of the Series A Preferred represented a return to the preferred shareholder and was treated in a similar manner as that of dividends paid on preferred stock. 

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LIQUIDITY AND CAPITAL RESOURCES

Our primary sources of liquidity are cash, cash equivalents and short-term investments.

 Based on currently available information as of March 8, 2018, we believe that our existing cash, cash equivalents, short-term investments and expected cash flows will be sufficient to fund our activities for the next 12 months.  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 that are synergistic with or complimentary to our technologies, we may be required to obtain more working capital.  We may seek to obtain working capital during our fiscal year ending 2018 or thereafter through sales of our equity securities or through bank credit facilities or public or private debt from various financial institutions where possible.  We cannot be certain that additional funding will be available on acceptable terms, or at all.  If we do identify sources for additional funding,the sale of additional equity securities or convertible debt could result in dilution to our shareholders.  Additionally, the sale of equity securities or issuance of debt securities may be subject to certain security holder approvals or may result in the downward adjustment of the exercise or conversion price of our outstanding securities.  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 three months ended January 31, 2018, cash used in operating activities was approximately $1,340,000.  Net cash provided by investing activities was approximately $847,000, which reflects the purchase of certificates of deposit totaling $1,250,000, offset by proceeds from the sale or maturity of certificates of deposit totaling $2,100,000 and the purchase of property and equipment of approximately $3,000.  As a result, our cash, cash equivalents and short-term investments at January 31, 2018 decreased by approximately $1,342,000 to approximately $5,497,000 from approximately $6,839,000 at the end of fiscal year 2017.

CRITICAL ACCOUNTING POLICIES

The Company’s condensed consolidated financial statements are prepared in conformity with accounting principles generally accepted in the United States of America.  In preparing these financial statements, we make assumptions, judgments and estimates that can have a significant impact on amounts reported in our condensed consolidated financial statements.  We base our assumptions, judgments and estimates on historical experience and various other factors that we believe to be reasonable under the circumstances.  Actual results could differ materially from these estimates under different assumptions or conditions.  On a regular basis, we evaluate our assumptions, judgments and estimates and make changes accordingly.

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We believe that, of the significant accounting policies discussed in Note 2 to our consolidated financial statements in our Annual Report on Form 10-K for the fiscal year ended October 31, 2017, the following accounting policies require our most difficult, subjective or complex judgments:

Revenue Recognition; and

Stock-Based Compensation

Revenue Recognition

Revenue is recognized when (i) persuasive evidence of an arrangement exists, (ii) all obligations have been substantially performed pursuant to the terms of the arrangement, (iii) amounts are fixed or determinable, and (iv) the collectability of amounts is reasonably assured.

Patent Licensing Revenue

In certain instances, our past revenue arrangements have provided for the payment of contractually determined 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 had no further obligations.   As such, the earnings process was complete and revenue has been recognized upon the execution of the agreement, when collectability was reasonably assured, and when all other revenue recognition criteria were met.

Stock-Based Compensation

The compensation cost for service based stock options granted to employees and directors is measured at the grant date, based on the fair value of the award using the Black-Scholes pricing model, and is recognized as an expense on a straight-line basis over the requisite service period (the vesting period of the stock option) which is one to ten years.  For service based stock options granted to consultants we estimate the fair value of the stock options and recognize expense at each reporting period using the Black-Scholes pricing model. 

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The Black-Scholes pricing model requires the input of highly subjective assumptions.  These variables include, but are not limited to, our stock price volatility over the term of the stock options, and actual and projected employee stock option exercise behaviors.

EFFECT OF RECENTLY ISSUED PRONOUNCEMENTS

We discuss the effect of recently issued pronouncements in the Notes to our Condensed Consolidated Financial Statements.

FORWARD-LOOKING STATEMENTS

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, (the “Securities Act”),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, 20172023 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 January 31, 2024 compared with three months ended January 31, 2023

Revenue

We had no revenue during the three-month periods ended January 31, 2024 and 2023.

We have not generated any revenue to date from our therapeutics or vaccine programs. In addition, while we pursue our therapeutics and vaccine programs, we may also make investments in and form new companies to develop additional emerging technologies. We do not expect to begin generating revenue with respect to any of our current therapy or vaccine programs in the near term. We hope to achieve a profitable outcome by eventually licensing our technologies to large pharmaceutical companies that have the resources and infrastructure in place to manufacture, market and sell our technologies as therapeutics or vaccines. The eventual licensing of any of our technologies may take several years, if it is to occur at all, and may depend on positive results from human clinical trials.

Research and Development Expenses

Research and development expenses are related to the development of our cancer therapeutics and vaccine programs and the expenses incurred in the three months ended January 31, 2024 consisted of approximately $629,000 and $720,000 for CAR-T therapeutics and cancer vaccines, respectively.

Research and development expenses increased by approximately $281,000 to approximately $1,349,000 in the three months ended January 31, 2024, from approximately $1,068,000 in the three months ended January 31, 2023. The increase in research and development expenses was primarily due to an increase in outside research and development expenses related to our breast cancer vaccine program of approximately $164,000, an increase in outside research and development expenses related to our CAR-T therapeutics program of approximately $141,000, and an increase in employee compensation and related costs, other than stock option compensation expense, of approximately $84,000, offset by a decrease in outside research and development expenses related to our ovarian cancer vaccine program of approximately $71,000.

General and Administrative Expenses

General and administrative expenses increased by approximately $772,000 to approximately $2,260,000 in the three months ended January 31, 2024, from approximately $1,488,000 in the three months ended January 31, 2023. The increase in general and administrative expenses was primarily due to an increase in investor and public relations expense of approximately $389,000, an increase in employee stock option compensation expense of approximately $95,000, an increase in legal and other professional fees of approximately $78,000, an increase in employee compensation and related costs, other than stock option compensation expense, of approximately $77,000, and an increase in director compensation, including stock option compensation, of approximately $72,000.

Interest Income

Interest income increased by approximately $117,000 to approximately $319,000 in the three months ended January 31, 2024, from approximately $202,000 in the three months ended January 31, 2023, due to an increase in interest rates and the increased dollar amount held in short-term investments.

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Net Loss Attributable to Noncontrolling Interest

The net loss attributable to noncontrolling interest, representing Wistar’s ownership interest in Certainty’s net loss, increased by approximately $3,000 to approximately $35,000 in the three months ended January 31, 2024 from approximately $32,000 in the three months ended January 31, 2023, as Certainty’s net loss increased.

LIQUIDITY AND CAPITAL RESOURCES

Our primary sources of liquidity are cash, cash equivalents and short-term investments.

Based on currently available information as of March 12, 2024, we believe that our existing cash, cash equivalents, short-term investments and expected cash flows will be sufficient to fund our activities for at least the next twelve months. We have implemented a business model that conserves funds by collaborating with third parties to develop our technologies. However, our projections of future cash needs and cash flows may differ from actual results. If current cash on hand, cash equivalents, short-term investments and cash that may be generated from our business operations are insufficient to continue to operate our business, or if we elect to invest in or acquire a company or companies or new technology or technologies that are synergistic with or complementary to our technologies, we may be required to obtain more working capital. During the three months ended January 31, 2024, we raised approximately $2,196,000, net of expenses, through an at-the-market equity offering of 555,820 shares of common stock, under which offering we may issue up to $100 million of common stock. Under our at-the-market equity program, which is currently effective and may remain available for us to use in the future, as of January 31, 2024, we may sell an additional approximately $98 million of common stock. We may seek to obtain working capital during our fiscal year 2024 or thereafter through sales of our equity securities or through bank credit facilities or public or private debt from various financial institutions where possible. We cannot be certain that additional funding will be available on acceptable terms, or at all. If we do identify sources for additional funding, the sale of additional equity securities or convertible debt will result in dilution to our stockholders. We can give no assurance that we will generate sufficient cash flows in the future to satisfy our liquidity requirements or sustain future operations, or that other sources of funding, such as sales of equity or debt, would be available or would be approved by our security holders, if needed, on favorable terms or at all. If we fail to obtain additional working capital as and when needed, such failure could have a material adverse impact on our business, results of operations and financial condition. Furthermore, such lack of funds may inhibit our ability to respond to competitive pressures or unanticipated capital needs, or may force us to reduce operating expenses, which would significantly harm the business and development of operations.

During the three months ended January 31, 2024, cash used in operating activities was approximately $2,309,000. Cash provided by investing activities was approximately $129,000, resulting from the maturities of short-term investments of approximately $20,149,000, offset by purchases of short-term investments totaling approximately $20,020,000. Cash provided by financing activities was approximately $2,263,000, resulting from the sale of 555,820 shares of common stock in an at-the-market equity offering of approximately $2,196,000, net of expenses, and the proceeds from stock option exercises of approximately $67,000. As a result, our cash, cash equivalents, and short-term investments at January 31, 2024 decreased approximately $46,000 to approximately $23,798,000 from approximately $23,844,000 at the end of fiscal year 2023.

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, 2023, the following accounting policies require our most difficult, subjective or complex judgments:

Revenue Recognition,
Stock-Based Compensation, and
Research and Development Expenses.

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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.

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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.

Research and Development Expenses

We recognize research and development expenses as incurred. Advance payments for future research and development activities are deferred and expensed as the services are performed. We recognize our preclinical studies and clinical trial expenses based on the services performed pursuant to contracts with research institutions, clinical research organizations (“CROs”), clinical manufacturing organizations (“CMOs”), and other parties that conduct and manage various stages of research and development activities on our behalf. Fees for such services are recognized based on management’s estimates after considering the activities and tasks completed by each service provider in a given period, the time period over which services are expected to be performed, and the level of effort expended in each reporting period.

At each balance sheet date, management estimates prepaid and accrued research and development costs by discussing progress or stage of completion of activities with internal personnel and external service providers, and comparing this information to payments made, invoices received, and the agreed-upon contractual fee to be paid for such services in the applicable contract or statements of work.

In addition, we allocate certain internal compensation costs to research and development expenses based on management’s estimates of each employee’s time and effort expended.

EFFECT OF RECENTLY ISSUED PRONOUNCEMENTS

We discuss the effect of recently issued pronouncements in Note 7 of the accompanying condensed consolidated financial statements.

Item 3. Quantitative and Qualitative Disclosures About Market Risk.

As of January 31, 2018,2024, we had investments in short-term, fixed rate and highly liquid instruments that have historically been reinvested when they mature throughout the year. Although our existing instruments are not considered at risk with respect to changes in interest rates or markets for these instruments, our rate of return on these securities could be affected at the time of reinvestment, if any.

Item 4. Controls and Procedures.

We carried out an evaluation, under the supervision and with the participation of our management including our President and Chief Executive Officer and our Chief Operating Officer and Chief Financial Officer, of the effectiveness of the design and operation of our disclosure controls and procedures pursuant to Rule 13-15(b)13(a)-15(b) of the Securities Exchange Act of 1934, as amended.Act. Based upon that evaluation, our President and Chief Executive Officer and our Chief Operating Officer and Chief Financial Officer concluded that our disclosure controls and procedures are effective as of the end of the period covered by this report. Report.

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There was no change in our internal control over financial reporting during the first quarter of fiscal year 2018three months ended January 31, 2024, that has materially affected, or is reasonably likely to materially affect, our internal control over financial reporting.


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Table of Contents

PART II. OTHER INFORMATION

Item 1. Legal Proceedings.Proceedings.

Other than suits we bringlawsuits related to enforcethe enforcement of our patent rights, we are not a party to any material pending legal proceedings, other thannor are we aware of any pending litigation or legal proceeding against us that which arise in the ordinary course of business.  We believe that any liability that may ultimately result from the resolution of these matters will not, individually or in the aggregate,would have a material adverse effect onupon our financial position or results of operations.operations or financial condition.

Item 1A. Risk Factors.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, 2017.2023.

Item 2. Unregistered Sales of Equity Securities and Use of Proceeds.Proceeds.

During the three months ended January 31, 2018,2024, the Company issued an aggregate of 5,34729,336 shares of our common stock to a companycompanies 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 SecuritiesSecurities..None.

Item 4. Mine Safety DisclosuresDisclosures.. Not Applicable.

Item 5. Other InformationInformation.. None.

Item 6. Exhibits.

31.1Certification of Chief Executive Officer, pursuant to Section 302 of the Sarbanes-Oxley Act of 2002, dated March 12, 2024.
31.2Certification of Chief Financial Officer, pursuant to Section 302 of the Sarbanes-Oxley Act of 2002, dated March 12, 2024.
32.1Statement of Chief Executive Officer, pursuant to Section 1350 of Title 18 of the United States Code, dated March 12, 2024.
32.2Statement of Chief Financial Officer, pursuant to Section 1350 of Title 18 of the United States Code, dated March 12, 2024.
101.INSInline XBRL Instance Document
101.SCHInline XBRL Taxonomy Extension Schema
101.CALInline XBRL Taxonomy Extension Calculation Linkbase
101.DEFInline XBRL Taxonomy Extension Definition Linkbase
101.LABInline XBRL Taxonomy Extension Label Linkbase
101.PREInline XBRL Taxonomy Extension Presentation Linkbase
104Cover Page Interactive Data File (formatted in Inline XBRL and contained in Exhibit 101)

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31.1     Certification of Chief Executive Officer, pursuant to Section 302 of the Sarbanes-Oxley Act of 2002, dated March 8, 2018.SIGNATURES

31.2     Certification of Chief Financial Officer, pursuant to Section 302 of the Sarbanes-Oxley Act of 2002, dated March 8, 2018.

32.1     Statement of Chief Executive Officer, pursuant to Section 1350 of Title 18 of the United States Code, dated March 8, 2018.

32.2     Statement of Chief Financial Officer, pursuant to Section 1350 of Title 18 of the United States Code, dated March 8, 201.


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SIGNATURES

Pursuant to the requirements of the Securities Exchange Act of 1934, the registrant has duly caused this report to be signed on its behalf by the undersigned, thereunto duly authorized.

ITUS CORPORATION

ANIXA BIOSCIENCES, INC.

By:

/s/ Dr. Amit Kumar

Dr. Amit Kumar

Chairman President and

Chief Executive Officer

March 8, 2018

12, 2024

(Principal Executive Officer)

By:

By:

/s/ Michael J. Catelani

Michael J. Catelani

President, Chief Operating Officer and

Chief Financial Officer

(Principal Financial and

March 8, 2018

12, 2024

Accounting Officer)

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