Table of Contents

UNITED STATES
SECURITIES AND EXCHANGE COMMISSION
WASHINGTON, D.C. 20549

 

FORM 10-Q

(Mark One)

 

x QUARTERLY REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934

 

For the quarterly period ended JanuaryJuly 31, 2018

2020

or

 

o TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934

        

For the transition period from __________ to __________

 

Commission file number333-68008

 

PHARMACYTE BIOTECH, INC.

(Exact name of registrant as specified in its charter)

 

Nevada62-1772151
(State or other jurisdiction of incorporation or organization)(I.R.S. Employer Identification No.)

 

23046 Avenida de la Carlota, Suite 600, Laguna Hills, CA 92653

(Address of principal executive offices)

 

(917) 595-2850

(Registrant’s telephone number, including area code)

Securities registered pursuant to Section 12(b) of the Act:
Title of each classTrading Symbol(s)Name of each exchange on which registered
N/AN/AN/A

 

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. YesxNoo

 

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) during the preceding 12 months (or for such shorter period that the registrant was required to submit and post such files). YesxNoo

 

Indicate by check mark whether the registrant is a large accelerated filer, an accelerated filer, a non-accelerated filer, a 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. (Check one)

 

 Large accelerated filer  oAccelerated filer  o
 Non-accelerated filer  oxSmaller reporting company  x
 Emerging growth company  o 

 

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.o

 

Indicate by check mark whether the registrant is a shell company (as defined in Rule 12b-2 of the Exchange Act). Yes oNox

 

As of March 19, 2018,September 11, 2020, the registrant had 1,013,260,6442,333,810,405 outstanding shares of common stock, with a par value of $0.0001 per share.

 

 

 

   

 

 

PHARMACYTE BIOTECH, INC.

INDEX TO QUARTERLY REPORT ON FORM 10-Q

FOR THE THREE AND NINE MONTHS ENDED JANUARYJULY 31, 20182020

 

  Page
PART I.FINANCIAL INFORMATION3
   
Item 1.Condensed Consolidated Financial Statements (Unaudited)3
 
 Condensed Consolidated Balance Sheets as of JanuaryJuly 31, 20182020 and April 30, 20172020 (Unaudited)3
 
 Condensed Consolidated Statements of Operations for the Three Months Ended July 31, 2020 and Nine Months Ended January 31, 2018 and 20172019 (Unaudited)4
   
 Condensed Consolidated Statements of Comprehensive Loss for the Three Months Ended July 31, 2020 and Nine Months Ended January 31, 2018 and 20172019 (Unaudited)5
   
 Condensed Consolidated Statements of Stockholders’ Equity for the Three Months Ended July 31, 2020 and 2019 (Unaudited)6
Condensed Consolidated Statements of Cash Flows for the NineThree Months Ended JanuaryJuly 31, 20182020 and 20172019 (Unaudited)67
 
 Notes to Condensed Consolidated Financial Statements (Unaudited)78
 
Item 2.Management’s Discussion and Analysis of Financial Condition and Results of Operations2527
 
Item 3.Quantitative and Qualitative Disclosures About Market Risk2932
   
Item 4.Controls and Procedures2932
   
PART II.OTHER INFORMATION3134
   
Item 1.Legal Proceedings3134
   
Item 1A.Risk Factors3134
   
Item 2.Unregistered Sales of Equity Securities and Use of Proceeds3134
   
Item 3.Defaults Upon Senior Securities3134
   
Item 4.Mine Safety Disclosures3134
   
Item 5.Other Information3134
   
Item 6.Exhibits3235
Signatures36

 

 

 

 2 

 

 

PART I – FINANCIAL INFORMATION

 

Item 1. Financial Statements.

 

PHARMACYTE BIOTECH, INC.

CONDENSED CONSOLIDATED BALANCE SHEETS

(UNAUDITED)

 

  January 31,  April 30, 
  2018  2017 
ASSETS        
Current assets:        
Cash $1,507,847  $3,464,229 
Prepaid expenses and other current assets  88,394   74,274 
Total current assets  1,596,241   3,538,503 
         
Other assets:        
Intangibles  3,549,427   3,549,427 
Investment in SG Austria  1,572,193   1,572,193 
Other assets  7,372   7,372 
Total other assets  5,128,992   5,128,992 
         
Total Assets $6,725,233  $8,667,495 
         
LIABILITIES AND STOCKHOLDERS' EQUITY        
Current liabilities:        
Accounts payable $305,592  $365,600 
Accrued expenses  281,564   214,648 
Binding term sheet obligation  300,000    
Total current liabilities  887,156   580,248 
         
Total Liabilities  887,156   580,248 
         
Commitments and Contingencies (Notes 8 and 10)        
         
Stockholders' equity:        
Common stock, authorized 1,490,000,000 shares, $0.0001 par value, 980,267,811 and 905,349,047 shares issued and outstanding as of January 31, 2018 and April 30, 2017, respectively  98,027   90,534 
Additional paid in capital  100,409,968   97,130,279 
Accumulated deficit  (94,668,675)  (89,135,302)
Accumulated other comprehensive income (loss)  (1,243)  1,736 
Total stockholders' equity  5,838,077   8,087,247 
         
Total Liabilities and Stockholders' Equity $6,725,233  $8,667,495 

  July 31,
2020
  April 30,
2020
 
ASSETS        
Current assets:        
Cash $2,166,596  $894,861 
Prepaid expenses and other current assets  136,537   142,785 
Total current assets  2,303,133   1,037,646 
         
Other assets:        
Intangibles  3,549,427   3,549,427 
Investment in SG Austria  1,572,193   1,572,193 
Other assets  7,372   7,372 
Total other assets  5,128,992   5,128,992 
         
Total Assets $7,432,125  $6,166,638 
         
LIABILITIES AND STOCKHOLDERS' EQUITY        
Current liabilities:        
Accounts payable $384,832  $185,842 
Accrued expenses  726,818   816,638 
Current portion of Small Business Administration – Paycheck Protection Program loan  41,498   28,918 
Total current liabilities  1,153,148   1,031,398 
         
Long-term liabilities, less current portion:        
Small Business Administration – Paycheck Protection Program loan  33,702   46,282 
         
Total Liabilities  1,186,850   1,077,680 
         
Commitments and Contingencies (Notes 7 and 9)        
         
Stockholders' equity:        
Common stock, authorized: 2,490,000,000 shares, $0.0001 par value; 1,875,143,738 and 1,638,637,839 shares issued and outstanding as of July 31, 2020 and April 30, 2020, respectively  187,515   163,864 
Additional paid-in capital  110,818,995   108,805,062 
Accumulated deficit  (104,742,203)  (103,858,259)
Accumulated other comprehensive loss  (19,032)  (21,709)
Total stockholders' equity  6,245,275   5,088,958 
         
Total Liabilities and Stockholders' Equity $7,432,125  $6,166,638 

 

See accompanying Notes to Condensed Consolidated Financial Statements.

 3 

 

PHARMACYTE BIOTECH, INC.

CONDENSED CONSOLIDATED STATEMENTS OF OPERATIONS

(UNAUDITED)

 

 Three Months Ended
January 31,
  Nine Months Ended
January 31,
  Three Months Ended July 31, 
 2018  2017  2018  2017  2020  2019 
              
Revenue $  $  $  $  $  $ 
                        
Operating Expenses:                
Operating expenses:        
Research and development costs  802,564   579,717   1,745,692   1,008,489   270,574   72,330 
Compensation expense  636,999   397,554   1,793,946   1,304,032   278,970   453,194 
Director fees  31,093   9,000   209,574   27,000   72,024   75,642 
Legal and professional  107,149   143,911   434,688   378,677   141,756   110,157 
General and administrative  452,855   151,833   1,349,473   569,409   118,352   422,752 
Total operating expenses  2,030,660   1,282,015   5,533,373   3,287,607   881,676   1,134,075 
                        
Loss from operations  (2,030,660)  (1,282,015)  (5,533,373)  (3,287,607)  (881,676)  (1,134,075)
                        
Other income (expense):            ��   
Other expense:        
Interest expense     (131)     (1,056)  (388)   
Total other income (expense), net     (131)     (1,056)
Other expense  (1,880)   
Total other expenses  (2,268)   
                        
Net loss $(2,030,660) $(1,282,146) $(5,533,373) $(3,288,663) $(883,944) $(1,134,075)
                        
Basic and diluted loss per share $(0.00) $(0.00) $(0.01) $(0.00) $(0.00) $(0.00)
                
Weighted average shares outstanding basic and diluted  975,848,246   859,529,933   958,198,483   832,203,911   1,678,572,167   1,210,305,834 

 

See accompanying Notes to Condensed Consolidated Financial Statements.

 

 

 4 

 

 

PHARMACYTE BIOTECH, INC.

CONDENSED CONSOLIDATED STATEMENTS OF COMPREHENSIVE LOSS

(UNAUDITED)

 

  

Three Months Ended

January 31,

  

Nine Months Ended

January 31,

 
  2018  2017  2018  2017 
             
Net Loss $(2,030,660) $(1,282,146) $(5,533,373) $(3,288,663)
Other comprehensive income:                
Foreign currency translation  (1,508)  300   (1,243)  1,944 
Other comprehensive income (loss)  (1,508)  300   (1,243)  1,944 
Comprehensive loss $(2,032,168) $(1,281,846) $(5,534,616) $(3,286,719)
  Three Months Ended July 31, 
  2020  2019 
       
Net loss $(883,944) $(1,134,075)
Other comprehensive income (loss):        
Foreign currency translation adjustment  2,677   (6,862)
Other comprehensive income (loss)  2,677   (6,862)
Comprehensive loss $(881,267) $(1,140,937)

 

See accompanying Notes to Condensed Consolidated Financial Statements.

 

 

 

 

 

 

 

 

 

 5

PHARMACYTE BIOTECH, INC.

CONDENSED CONSOLIDATED STATEMENT OF STOCKHOLDERS' EQUITY

THREE MONTHS ENDED JULY 31, 2020 AND 2019 

(UNAUDITED)

  Common stock  Additional Paid-in  Accumulated  Accumulated Other
Comprehensive
  Total
Stockholders’
 
  Shares  Amount  Capital  Deficit  Loss  Equity 
                   
Balance, April 30, 2020  1,638,637,839  $163,864  $108,805,062  $(103,858,259) $(21,709) $5,088,958 
                         
Stock issued for compensation        67,320         67,320 
Stock issued for services  2,500,000   250   40,300         40,550 
Stock issued for cash, net of issuance costs of $194,150  234,005,899   23,401   1,833,996         1,857,397 
Stock-based compensation options        72,317         72,317 
Foreign currency translation adjustment              2,677   2,677 
Net loss           (883,944)     (883,944)
Balance, July 31, 2020  1,875,143,738  $187,515  $110,818,995  $(104,742,203) $(19,032) $6,245,275 
                         
Balance, April 30, 2019  1,186,004,505  $118,600  $104,966,158  $(100,031,371) $(13,842) $5,039,545 
                         
Stock issued for compensation        104,726         104,726 
Stock issued for services  5,500,000   550   311,266         311,816 
Stock issued for cash, net of issuance costs of $42,000  66,666,667   6,667   551,333         558,000 
Stock-based compensation options        126,325         126,325 
Foreign currency translation adjustment              (6,862)  (6,862)
Net loss           (1,134,075)     (1,134,075)
Balance, July 31, 2019  1,258,171,172  $125,817  $106,059,808  $(101,165,446) $(20,704) $4,999,475 

See accompanying Notes to Condensed Consolidated Financial Statements.

6 

 

 

PHARMACYTE BIOTECH, INC.

CONDENSED CONSOLIDATED STATEMENTS OF CASH FLOWS

(UNAUDITED)

 

  Nine Months Ended January 31, 
  2018  2017 
Cash flows from operating activities:        
Net loss $(5,533,373) $(3,288,663)
Adjustments to reconcile net loss to net cash used in operating activities:        
Stock issued for services  201,576   72,950 
Stock issued for compensation  488,290   191,680 
Stock based compensation – options  766,382   456,002 
Change in assets and liabilities:        
Decrease in prepaid expenses and other current assets  65,405   88,828 
Increase (decrease) in accounts payable  (60,008)  98,991 
Increase (decrease) in accrued expenses  66,916   (8,363)
Increase in binding term sheet obligation  300,000    
Decrease in license agreement obligation     (150,000)
Net cash used in operating activities  (3,704,812)  (2,538,575)
         
Cash flows from investing activities:        
Net cash provided by (used in) investing activities      
         
Cash flows from financing activities:        
Proceeds from sale of common stock  1,751,409   3,080,883 
Net cash provided by financing activities  1,751,409   3,080,883 
         
Effect of currency rate exchange on cash  (2,979)  1,138 
         
Net increase (decrease) in cash  (1,956,382)  543,446 
         
Cash at beginning of the period  3,464,229   1,920,825 
Cash at end of the period $1,507,847  $2,464,271 
         
Supplemental disclosures of cash flows information:        
Cash paid during the period for interest $  $1,056 

  Three Months Ended July 31, 
  2020  2019 
Cash flows from operating activities:        
Net loss $(883,944) $(1,134,075)
Adjustments to reconcile net loss to net cash used in operating activities:        
Stock issued for services  40,550   311,816 
Stock issued for compensation  67,320   104,726 
Stock-based compensation – options  72,317   126,325 
Change in assets and liabilities:        
(Increase) decrease in prepaid expenses and other current assets  6,248   (11,137)
Increase (decrease) in accounts payable  198,990   (54,337)
Decrease in accrued expenses  (52,483)  (106,458)
Net cash used in operating activities  (551,002)  (763,140)
         
Cash flows from investing activities:        
Net cash provided by (used in) investing activities      
         
Cash flows from financing activities:        
Use of funds for payment of insurance financing loan  (37,337)   
Proceeds from sale of common stock, net of issuance costs  1,857,397   582,500 
Net cash provided by financing activities  1,820,060   582,500 
         
Effect of currency rate exchange on cash  2,677   (6,862)
         
Net increase (decrease) in cash  1,271,735   (187,502)
         
Cash at beginning of the period  894,861   515,253 
Cash at end of the period $2,166,596  $327,751 

 

Supplemental disclosure of cash flows information:

        
Cash paid during the periods for income taxes $800  $800 
Cash paid during the periods for interest $388  $ 
         
Supplemental schedule of noncash investing and financing activity:        
Issuance costs for shares issued $  $24,500 

    

See accompanying Notes to Condensed Consolidated Financial Statements.

 

 

 

 67 

 

 

PHARMACYTE BIOTECH, INC.

NOTES TO CONDENSED CONSOLIDATED FINANCIAL STATEMENTS

(UNAUDITED)

 

NOTE 1 – NATURE OF BUSINESS

 

Overview

PharmaCyte Biotech, Inc. (“Company”) is a clinical stage biotechnology company focused on developing and preparing to commercialize cellular therapies for cancer and diabetes based upon a proprietary cellulose-based live cell encapsulation technology known as “Cell-in-a-Box®.” The Cell-in-a-Box®technology is intended to be used as a platform upon which therapies for several types of cancer, including locally advanced, non-metastatic inoperable, pancreatic cancer (“LAPC”), and Type 1 and insulin dependent Type 2 diabetes will be developed.

 

The Company is developing therapies for pancreatic and other solid cancerous tumors by using genetically engineered live human cells that it believes are capable of converting a cancer prodrug into its cancer-killing form, encapsulating those cells using the encapsulation of live cells which are surgically implanted at appropriate sitesCell-in-a-Box® technology and placing those capsules in the body as close as possible to enable the deliverytumor. In this way, the Company believes that when the cancer prodrug is administered to a patient with a particular type of cancer-killing chemotherapy drug atcancer that may be affected by the sourceprodrug, the killing of the cancer.patient’s tumor may be optimized. On September 1, 2020, the Company submitted an Investigational New Drug Application (“IND”) to the U.S. Food and Drug Administration (“FDA”) for a planned Phase 2b clinical trial in LAPC. On September 4, 2020, the Company received an Information Request from the FDA. The Company responded to the FDA’s Information Request on September 11, 2020. See Note 13 “Subsequent Events”.

 

The Company is also developing a therapy for Type 1 diabetes and insulin-dependent Type 2 diabetes. The Company’s diabetes therapy consists of encapsulating genetically modified human cells and/or beta islet cells using the Cell-in-a-Box® technology and then implanting them in the body to act as a bio-artificial pancreas for insulin production.

In addition, the Company is examining ways to exploit the benefits of the Cell-in-a-Box® technology to develop therapies for cancer that involve prodrugs based upon thecertain constituents of the Cannabis plant,plant; these constituents are of the class of compounds known as “Cannabinoids.“cannabinoids.

Cancer Therapy

Targeted Chemotherapy

The Company’s live-cell encapsulation technology consists of encapsulating different types of genetically modified living cells, depending on Until the disease being treated. For its leading product candidate, a therapy for pancreatic cancer, about 10,000 genetically modified live cells that produce an enzyme, which convertsFDA allows the chemotherapy prodrug ifosfamide into its cancer-killing form, are encapsulated in porous, pinhead-sized capsules usingCompany to commence the Cell-in-a-Box® technology. In each patient to be treated, about 300 of these capsules will be surgically implantedclinical trial involving LAPC described in the blood supply as close to the pancreas tumor as possible. Once that is completed, the chemotherapy prodrug ifosfamide is given to the patient intravenously at one-third the normal dose. The prodrug is normally activated in the patient’s liver. By activating the prodrug near the tumor using the Cell-in-a-Box® capsules, the Company’s cellular therapy acts as a type of “artificial liver.” Using this “targeted chemotherapy”recently filed IND, the Company is seeking to create an environment that enables optimal concentrations of the “cancer-killing” form of ifosfamide at the site of the tumor. Because the cancer-killing form of ifosfamide has a short half-life,not spending any further resources developing this program.

In addition, the Company believes that by using this treatment approach it results in little to no collateral damage to other organs in the body. The Company believes this treatment significantly reduces tumor size with no treatment-related side effects.

Pancreatic Cancer Therapy

A critical unmet medical need exists for patients with pancreatic cancer whose tumors are locally advanced, non-metastatic and inoperable but no longer respond to Abraxane® plus gemcitabine, the current standard of care for advanced pancreatic cancer. These patients have no effective treatment alternative once their tumors no longer respond to this combination therapy. Commonly used treatments for these types of patients include 5-fluorouracil (“5-FU”) or capecitabine (a prodrug of 5-FU) with or without radiation. However, such treatments are only marginally effective in treating the tumor and result in serious side effects. The Company is developing a therapy that it believes can serve as a “consolidation therapy” with Abraxane® plus gemcitabine that addresses the critical unmet medical need.

7

Subject to FDA approval, the Company plans to commence a Phase 2b clinical trial involving locally advanced, inoperable non-metastatic pancreatic cancer. The Company had a Pre-Investigational New Drug Application (“Pre-IND”) meeting with the Center for Biologics Evaluation and Research of the FDA on January 17, 2017. At the Pre-IND meeting, the FDA informed the Company it agreed with certain aspects of the Company’s development plan, charged the Company with completing numerous tasks and provided the Company with the guidance the Company needs to complete what it expects will be a successful Investigational New Drug Application (“IND”) process, although no assurance can be given whether the FDA will approve the Company’s IND once it is submitted. The proposed clinical trial is designed to show that the Company’s Cell-in-a-Box® plus low-dose ifosfamide therapy can serve as an effective and safe consolidation chemotherapy for patients whose tumors no longer respond after four to six months of therapy with Abraxane® plus gemcitabine. The trial will take place in the United States with possible study sites in Europe.

Malignant Ascites Fluid Therapy

The Company is also developing a therapy to delay the production and accumulation of malignant ascites fluid that results from many types of abdominal cancerous tumors. Malignant ascites fluid is secreted by an abdominal tumorcancerous tumors into the abdomen after the tumor reachestumors have reached a certain stage of growth. This fluid contains cancer cells that can seed and form new tumors throughout the abdomen. This fluid accumulates in the abdominal cavity, causing swelling of the abdomen, severe breathing difficulties and extreme pain.

 

Malignant ascites fluid must be removed by paracentesis on a periodic basis. This is painful and costly. There is no therapy that prevents or delays the production and accumulation of malignant ascites fluid. The Company has been involved in a series of preclinical studies conducted by Translational Drug Developmentis using its therapy for pancreatic cancer to determine if the combination of Cell-in-a-Box® encapsulated cells plus ifosfamideit can prevent or delay the production and accumulation of malignant ascites fluid. The Company plansAs with the Company’s Cannabis program, until the FDA allows it to conduct another preclinical studycommence the clinical trial involving LAPC described in Germany. If the preclinical studies are successful andits recently filed IND, the Company receives approval to do so from the FDA, the Company plans to conduct a clinical trial in the United States. The Company also plans to have additional study sites in Europe if it receives approval to do so from the European Medicines Agency.

Diabetes Therapy

Bio-Artificial Pancreas for Diabetesis not spending any further resources developing this program.

 

The Company plans to developis also developing a therapy for Type 1 diabetes and insulin-dependent Type 2 diabetes. ItThe Company’s diabetes therapy consists of encapsulated genetically modified human liver cells and insulin-producing stem cells. The encapsulation for each type of cell will be done using the Cell-in-a-Box® technology. Implanting these cells in the body is designed to function as a bio-artificial pancreas for purposes of insulin production. As with the two previous programs, the Company is not spending any further resources developing a therapy that involves encapsulationthis program until the FDA allows it to commence the clinical trial involving LAPC described in its recently filed IND. Additionally, work at the University of Technology, Sydney (“UTS”) on the Melligen cells continues. Melligen cells are human liver cells that have been genetically engineered to produce, store insulin and release insulin on demand at levels in proportionresponse to the levels of blood sugar (glucose) in the human body. It also plans to explore the encapsulation of beta islet cells as an alternative to using genetically modified human cells. The encapsulation will be done using the Cell-in-a-Box® technology.

 

Cannabis Therapy

Cannabinoids

The Company plans to use Cannabinoids to develop therapies for cancer, with the initial target of brain cancer. The Company is focusing on developing specific therapies based on carefully chosen molecules rather than using complexCannabis extracts. The Company’s therapy will use the Cell-in-a-Box® technology in combination with genetically modified cell lines designed to activate cannabinoid molecules for the treatment of diseases and their related symptoms.

To further itsCannabis therapy development plans,Finally, the Company entered into a Research Agreement in May 2014 withhas licensed (“Hai Kang License Agreement”) from Hai Kang Life Corporation (“Hai Kang”) the University of Northern Colorado. The goal of the research isright to develop methods for the identification, separation and quantification of constituents of Cannabis, some of which are prodrugs, that may be used in combination with the Cell-in-a-Box® certain technology owned or controlled by Hai Kang related to treat cancer. Studies have been undertaken using cannabinoids to identify the appropriate cell type that can convert the selected cannabinoid prodrugs into metabolites with anticancer activity. Once identified, the genetically modified cells which are expected to produce the appropriate enzyme to convert that cannabinoid prodrug will be encapsulated using the Cell-in-a-Box® technology. The encapsulated cells and cannabinoid prodrugs identified by these studies will then be combined and used for future studies to evaluate their anticancer effectiveness.SARS-Cov2 COVID-19 diagnostic kits (“Kits”).

 

 

 

 8 

 

 

The Company’s license is both for the sale of Kits as well as for the use of the technology underlying the Kits. Pursuant to the Hai Kang License Agreement, the Company may directly (or through a third party) conduct research, use, develop, market, sell, distribute, import and export Kits and utilize their underlying technology for human and veterinary uses in North America, the United Kingdom and certain other European sites. A Kit is defined as any existing Kit of Hai Kang or any future Kit derived from Hai Kang’s Kits. The Kits will be manufactured and supplied to the Company by Hai Kang. With respect to the Hai Kang License Agreement and related products, including the Kits, we may not be able to (i) develop a related product candidate with our current resources, on a timely basis, or at all; (ii) obtain the necessary regulatory authorizations or approvals for such a product candidate or for a Kit; (iii) commercialize any such product candidate or Kit; or (iv) obtain reimbursement for such a product candidate or Kit in the U.S. and elsewhere. It is uncertain that any such product candidates or Kit will comply with U.S. regulatory requirements or that any health care facility or provider will be willing or able to use such product candidates or Kits.

Impact of the COVID-19 Pandemic on the Company’s Operations

The coronavirus SARS-Cov2 (“COVID-19”) pandemic is causing significant, industry-wide delays in clinical trials. Although the Company is not yet in a clinical trial, the Company has filed an IND with the FDA to commence a clinical trial in LAPC and is awaiting a response from the FDA. Currently, many clinical trials are being delayed due to COVID-19. There are numerous reasons for these delays. For example, patients have shown a reluctance to enroll or continue in a clinical trial due to fear of exposure to COVID-19 when they are in a hospital or doctor’s office. There are local, regional and state-wide orders and regulations restricting usual normal activity by people. These discourage and interfere with patient visits to a doctor’s office if the visit is not COVID-19 related. Healthcare providers and health systems are shifting their resources away from clinical trials toward the care of COVID-19 patients. The FDA and other healthcare providers are making product candidates for the treatment of COVID-19 a priority over product candidates unrelated to COVID-19. As of the date of this Report on Form 10-Q (“Report”), the COVID-19 pandemic has had an impact upon the Company’s operations, although the Company believes that impact is not material. The impact primarily relates to delays in tasks associated with the preparation of the Company’s recently submitted IND to treat LAPC. There may be further delays in generating responses required by the Company to comments by or requests from the FDA related to the IND.

As a result of the COVID-19 pandemic, commencement of the Company’s planned clinical trial to treat LAPC may be delayed. Also, enrollment may be difficult for the reasons discussed above. In addition, after enrollment in the trial, if patients contract COVID-19 during their participation in the trial or are subject to isolation or shelter in place restrictions, this may cause them to drop out of our trial, miss scheduled therapy appointments or follow-up visits or otherwise fail to follow the trial protocol. If patients are unable to follow the trial protocol or if the trial results are otherwise affected by the consequences of the COVID-19 pandemic on patient participation or actions taken to mitigate COVID-19 spread, the integrity of data from the trial may be compromised or not be accepted by the FDA. This could impact or delay the Company’s clinical development program.

It is highly speculative in projecting the effects of COVID-19 on the Company’s clinical development program and the Company generally. The effects of COVID-19 quickly and dramatically change over time. Its evolution is difficult to predict, and no one is able to say with certainty when the pandemic will subside and life as we knew it before the pandemic will return to normal.

Company Background and Material Agreements

 

The Company is a Nevada corporation incorporated in 1996. In 2013, the Company restructured its operations to focus on biotechnology. The restructuring resulted in the Company focusing all its efforts upon the development of a novel, effective and safe way to treat cancer and diabetes. OnIn January 6, 2015, the Company changed its name from Nuvilex, Inc. to PharmaCyte Biotech, Inc. to better reflect the nature of its restructuredcurrent business.

 

In

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Commencing in May 2011, the Company entered into an Asset Purchase Agreement (“APA”)a series of agreements and amendments with SG Austria Private Limitedto acquire certain assets from SG Austria as well as an exclusive, worldwide license to use, with a right to sublicense, the Cell-in-a-Box® technology and trademark for the development of therapies for cancer. (“SG Austria”) to purchase 100% of the assets and liabilities of SG Austria. Austrianova Singapore Pte. Ltd. (“Austrianova”) and Bio Blue Bird AG (“Bio Blue Bird”), wholly-owned subsidiaries of SG Austria were to become wholly-owned subsidiaries of the Company on the condition that the Company pay SG Austria $2.5 million and 100,000,000 shares of common stock of the Company. The Company was to receive 100,000 shares of common stock of Austrianova and nine bearer shares of Bio Blue Bird representing 100% of the ownership of Bio Blue Bird.

Through addenda to the APA, the closing date of the APA was extended twice by agreement between the parties.APA”)

 

In June 2013, the Company and SG Austria entered a Third Addendum to the SG Austria APA (“Third Addendum”). The Third Addendum materially changed materially the transaction contemplated by the SG Austria APA. Under the Third Addendum, the Company acquired 100% of the equity interests in Bio Blue Bird and received a 14.5% equity interest in SG Austria. In addition, the Company received nine bearer shares of Bio Blue Bird to reflect its 100% ownership of Bio Blue Bird. The Company paid: (i) $500,000 to retire all outstanding debt of Bio Blue Bird; and (ii) $1.0 million to SG Austria. The Company also paid SG Austria $1,572,193 in exchange for thea 14.5% equity interest of SG Austria. The Third Addendumtransaction required SG Austria to return to the Company the 100,000,000 shares of our common stock held by SG Austria and for the Company to return to SG Austria the 100,000 shares of common stock of Austrianova thatwhich the Company held.

 

Effective as of the same date ofthe Company entered into the Third Addendum, the partiesCompany and SG Austria also entered into a Clarification Agreement to the Third Addendum (“Clarification Agreement”) to clarify and include certain language that was inadvertently left out of the Third Addendum. Among other things, the Clarification Agreement confirmed that the Third Addendum granted the Company an exclusive, worldwide license to use, with a right to sublicense, the Cell-in-a-Box® technologyTrademark and its Associated Technology for the development of treatmentstherapies for cancer and use of Austrianova’s Cell-in-a-Box®trademark and associated technology.cancer.

 

With respect to Bio Blue Bird, licensed certain types of genetically modified human cells from Bavarian Nordic A/S (“Bavarian Nordic”) and GSF-Forschungszentrum für Umwelt u. Gesundheit GmbH (collectively, “Bavarian Nordic/GSF”) pursuant toand Bio Blue Bird entered into a non-exclusive License Agreement (“Bavarian Nordic/GSF License Agreement”) in July 2005, whereby Bio Blue Bird was granted a non-exclusive license to further develop, make, have made (including services under contract for Bio Blue Bird or a therapysub-licensee, by Contract Manufacturing Organizations, Contract Research Organizations, Consultants, Logistics Companies or others), obtain marketing approval, sell and offer for sale the clinical data generated from the pancreatic cancer using a certain type of encapsulatedclinical trials that used the cells (“Cells”and capsules developed by Bavarian Nordic/GSF (then known as “CapCells”). The or otherwise use the licensed patent rights to the Cells pertain torelated thereto in the countries in which Bavarian Nordic/GSF obtained patent protection. Hence, facilitated by the acquisition ofpatents had been granted. Bio Blue Bird was required to pay Bavarian Nordic a royalty of 3% of the Third Addendum providesnet sales value of each licensed product sold by Bio Blue Bird and/or its Affiliates and/or its sub-licensees to a buyer. The term of the Company with an exclusive, worldwideBavarian Nordic/GSF License Agreement continued on a country by country basis until the expiration of the last valid claim of the licensed patent rights.

Bavarian Nordic/GSF and Bio Blue Bird amended the Bavarian Nordic License Agreement in December 2006 (“First Amendment to Bavarian Nordic/GSF License Agreement”) to reflect that: (i) the license granted was exclusive; (ii) a royalty rate increased from 3% to use4.5%; (iii) Bio Blue Bird assumed the Cell-in-a-Box® technology and trademarkpatent prosecution expenses for the developmentexisting patents; and (iv) to make clear that the license will survive as a license granted by one of a therapy for all formsthe licensors if the other licensor rejects performance under the Bavarian Nordic License Agreement due to any actions or declarations of cancer using these encapsulated Cells.insolvency.

 

In June 2013, the Company acquired from Austrianova an exclusive, worldwide license to use the Cell-in-a-Box® technologyTrademark and trademarkits Associated Technology for the development of a therapy for Type 1 and insulin-dependent Type 2 diabetes (“Diabetes Licensing Agreement”). TheThis allows the Company paid Austrianova $2.0 million to secure this license.develop a therapy to treat diabetes through encapsulation of a human cell line that has been genetically modified to produce, store and release insulin in response to the levels of blood sugar in the human body.

 

In October 2014, the Company entered into an exclusive, worldwide license agreement with the UTS (“Melligen Cell License Agreement”) with the University of Technology Sydney (“UTS”) in Australia to use insulin-producing genetically engineered human liver cells (“Melligen Cells”) developed by UTS to treat Type 1 diabetes and insulin-dependent Type 2 diabetes. The Company plansThese cells, named “Melligen”, were tested by UTS in mice and shown to develop an effective therapy for diabetes by encapsulatingproduce insulin in direct proportion to the amount of glucose in their surroundings. In those studies, when Melligen cells were transplanted into immunosuppressed diabetic mice, the blood glucose levels of the mice became normal. In other words, the Melligen Cells usingcells reportedly reversed the Cell-in-a-Box® technology.diabetic condition.

 

 

 

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In December 2014, the Company acquired from Austrianova an exclusive, worldwide license to use the Cell-in-a-Box® technologyTrademark and its Associated Technology in combination with genetically modified non-stem cell lines which are designed to activate Cannabinoidcannabinoid prodrug molecules for development of therapies for diseases and their related symptoms using of the Cell-in-a-Box® technology and trademark (“Cannabis Licensing Agreement”). This allows the Company to develop a therapy to treat cancer and other diseases and symptoms through encapsulation of genetically modified cells designed to convert cannabinoids to their active form using the Cell-in-a-Box® trademark and its associated technologies.

 

In July 2016, the Company entered into a Binding Memorandum of Understanding with Austrianova (“Austrianova MOU”). Pursuant to the Austrianova MOU, Austrianova agreed towill actively work with the Company to seek an investment partner in territories not covered by the Bavarian Nordic/GSF License Agreement. The plan is for the investment partner toor partners who will finance clinical trials and further develop products for the Company’s therapy for cancer, in exchange for which the Company, Austrianova and any future investment partner will each receive a portion of the net revenue from the sale of cancer products.

 

In October 2016, the partiesBavarian Nordic/GSF and Bio Blue Bird further amended the Bavarian Nordic License Agreement (“Second Amendment to Bavarian Nordic/GSF License Agreement toAgreement”) in order to: (i) include the right to import in the scope of the license; (ii) reflect ownership and notification of improvements,improvements; (iii) clarify which provisions survive expiration or termination of the Bavarian Nordic/GSFNordic License Agreement, toAgreement; (iv) provide rights to Bio Blue Bird to the clinical data after the expiration of the licensed patent rightsrights; and to(v) change the notice address and recipients of Bio Blue Bird.

 

In August 2017,May 2018, the Company entered into a series of binding term sheet amendments (“Binding Term Sheet withAmendments”). The Binding Term Sheet Amendments provide that the Company’s obligation to make milestone payments to Austrianova is eliminated in their entirety under the: (i) Cannabis License Agreement; and (ii) the Diabetes License Agreement, as amended. The Binding Term Sheet Amendments also provide that the Company’s obligation to make milestone payments to SG Austria for therapies for cancer to be eliminated in their entirety. In addition, the Binding Term Sheet Amendments also provides that the scope of the Diabetes License Agreement is expanded to include all cell types and Austrianova pursuantcell lines of any kind or description now or later identified, including, but not limited to, whichprimary cells, mortal cells, immortal cells and stem cells at all stages of differentiation and from any source specifically designed to produce insulin for the parties reached an agreement to amend certain provisionstreatment of diabetes.

In addition, one of the Binding Term Sheet Amendments provides that the Company will have a 5-year right of first refusal from August 30, 2017 in the APA,event that Austrianova chooses to sell, transfer or assign at any time during this period the Diabetes Licensing AgreementCell-in-a-Box® Trademark and Associated Technologies , intellectual property, trade secrets and know-how, which includes the Cannabis Licensing Agreement. See Note 10, Commitmentsright to purchase any manufacturing facility used for the Cell-in-a-Box® encapsulation process and Contingencies,a non-exclusive license to use the special cellulose sulfate utilized with the Cell-in-a-Box® encapsulation process (collectively, “Associated Technologies”); provided, however, that the Associated Technologies subject to the right of first refusal do not include Bac-in-a-Box®. Additionally, for additional information.

NOTE 2 – LIQUIDITY

Liquiditya period of one year from August 30, 2017 one of the Binding Term Sheet Amendments provides that Austrianova will not solicit, negotiate or entertain any inquiry regarding the potential acquisition of the Cell-in-a-Box® and its Associated Technologies.

 

The Company's Condensed Consolidated Financial Statements are prepared in accordance with United States generally accepted accounting principles (“U.S. GAAP”) applicable to a going concern which contemplatesBinding Term Sheet Amendments further provide that: (i) the realization of assets and liquidation of liabilitiesroyalty payments on gross sales as specified in the normal courseSG Austria APA, the Cannabis License Agreement and the Diabetes License Agreement are changed to 4%; and (ii) the royalty payments on amounts received by the Company from sublicensees on sublicensees’ gross sales under the same agreements are changed to 20% of business.the amount received from the sublicensees, provided, however, that in the event the amounts received by the Company from sublicensees is 4% or less of sublicensees’ gross sales, Austrianova will receive 50% of what the Company receives (up to 2%) and then additionally 20% of any amount the Company receives over that 4%.

One of the Binding Term Sheet Amendments requires that the Company pay $900,000 to Austrianova ratably over a nine-month period in the amount of two $50,000 payments each month during the nine-month period on the days of the month to be agreed upon between the parties, with a cure period of 20 calendar days after receipt by the Company of written notice from Austrianova that the Company has failed to pay timely a monthly payment. As of January 31, 2018,April 30, 2020, the Company had an accumulated deficit$900,000 amount has been paid in full. The Binding Term Sheet Amendments also provide that Austrianova receives 50% of $94,668,675any other financial and incurred a net loss fornon-financial consideration received from the nine months ended January 31, 2018 of $5,533,373.

During the nine months ended January 31, 2018, funding was provided by investors to maintain and expand the Company. The remaining challenges, beyond the regulatory and clinical aspects, include accessing funding for the Company to cover its future capital requirements. During the previous fiscal year and through the nine months ended January 31, 2018, the Company continued to acquire funds through salesCompany’s sublicensees of the Company’s common stock pursuant to the Company’s Registration Statement on Form S-3 under which the Company’s placement agent sold shares of the Company’s common stock “at-the-market” or pursuant to “block trades” in a program structured to provide up to $50 million in funding to the Company less certain commissions.Cell-in-a-Box® technology.

 

The Company requires substantial additional capital to finance its planned business operations and expects to incur operating losses in future periods due to the expenses related to the Company’s core businesses. The Company has not realized any revenue since it commenced doing business in the biotechnology sector, and there can be no assurance that it will be successful in generating revenues in the future in this sector.

The Company believes its cash on hand at January 31, 2018, sales of registered and unregistered shares of its common stock and any public offerings of common stock in which the Company may engage in will provide sufficient capital to meet the Company’s capital requirements and to fund the Company’s operations through March 31, 2019.

The Company will continue to be dependent on outside capital to fund its research and operating expenditures for the foreseeable future. If the Company fails to generate positive cash flows or fails to obtain additional capital when required, the Company may need to modify, delay or abandon some or all its business plans.

The Company’s ability to use its current Form S-3 will be retested at the time of the Company’s filing of its Form 10-K for fiscal year 2018. If the Company does not meet the eligibility requirements of its current Form S-3, it will not be eligible to continue to use it to raise capital. In such event, the Company would need to raise capital pursuant to a Form S-1 or pursuant to private placements. Either method could entail greater time periods to raise capital and could entail increased total costs.

 

 

 

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NOTE 32 – SUMMARY OF SIGNIFICANT ACCOUNTING POLICIES

General

The accompanying Condensed Consolidated Financial Statements as of January 31, 2018 and for the three and nine months ended January 31, 2018 and 2017 are unaudited. These unaudited Condensed Consolidated Financial Statements have been prepared in accordance with U.S. GAAP for interim financial information and are presented in accordance with the requirements of Regulation S-X of the United States Securities and Exchange Commission (“Commission”) and with the instructions to Form 10-Q. Accordingly, they do not include all the information and footnotes required by U.S. GAAP for complete Condensed Consolidated Financial Statements.

In the opinion of management, all adjustments (consisting of normal recurring accruals) considered necessary for a fair presentation have been included. Operating results for the three and nine months ended January 31, 2018 are not necessarily indicative of the results that may be expected for the fiscal year ending April 30, 2018. The unaudited Condensed Consolidated Financial Statements should be read in conjunction with the audited Consolidated Financial Statements as of and for the fiscal year ended April 30, 2017 and the Notes thereto included in the Company’s Annual Report on Form 10-K for the period ended April 30, 2017 (“Form 10-K”) the Company filed with the Commission.

The Condensed Consolidated Balance Sheet as of April 30, 2017 contained herein has been derived from the audited Consolidated Financial Statements as of April 30, 2017, but does not include all disclosures required by U.S. GAAP.

 

Principles of Consolidation and Basis of Presentation

 

The Condensed Consolidated Financial Statements include the accounts of the Company and its wholly owned subsidiaries. The Company operates independently and through four wholly-ownedwholly owned subsidiaries: (i) Bio Blue Bird; (ii) PharmaCyte Biotech Europe Limited; (iii) PharmaCyte Biotech Australia Private Limited.Pty. Ltd.; and (iv) Viridis Biotech, Inc. and are prepared in accordance with United States Generally Accepted Accounting Principles (“U.S. GAAPGAAP”) and the rules and regulations of the Commission.United States Securities and Exchange Commission (“Commission”). Intercompany balances and transactions are eliminated. The Company’s 14.5% investment in SG Austria is presented on the cost method of accounting.

 

Use of Estimates

 

The preparation of Condensed Consolidated Financial Statementsfinancial statements in accordance with U.S. GAAP requires the use of estimates and assumptions that affect the reported amounts of assets and liabilities, disclosure of contingent assets and liabilities known to exist as of the date the financial statements are published and the reported amounts of revenues and expenses during the reporting period. On an ongoing basis, the Company evaluates these estimates including those related to fair values of financial instruments, intangible assets, fair value of stock-based awards, income taxes and contingent liabilities, among others. Uncertainties with respect to such estimates and assumptions are inherent in the preparation of the Company’s Condensed Consolidated Financial Statements; accordingly, it is possible that the actual results could differ from these estimates and assumptions, which could have a material effect on the reported amounts of the Company’s condensed consolidated financial position and results of operations.

 

Intangible Assets

 

The Financial Accounting Standards Board ("FASB") standard on goodwill and other intangible assets prescribes a two-step process for impairment testing of goodwill and indefinite-lived intangibles, which is performed annually, as well as when an event triggering impairment may have occurred. The first step tests for impairment, while the second step, if necessary, measures the impairment. The Company has elected to perform its annual analysis at the end of its reporting year.

 

The Company’s intangible assets are licensing agreements related to the Cell-in-a-Box®technology for $1,549,427 and the diabetes license for $2,000,000 for an aggregate total of $3,549,427.

 

These intangible assets have an indefinite life; therefore, they are not amortizable.

 

The Company concluded that there was no impairment of the carrying value of the intangibles for the ninethree months ended JanuaryJuly 31, 2018.2020 and 2019.

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Impairment of Long-Lived Assets

 

The Company evaluates long-lived assets for impairment whenever events or changes in circumstances indicate that the carrying value of an asset may not be fully recoverable. If the estimated future cash flows (undiscounted and without interest charges) from the use of an asset are less than carrying value, a write-down would be recorded to reduce the related asset to its estimated fair value. No impairment was identified or recorded during the ninethree months ended JanuaryJuly 31, 2018.2020 and 2019.

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Fair Value of Financial Instruments

 

For certain of the Company’s non-derivative financial instruments, including cash, accounts payable and accrued expenses, the carrying amount approximates fair value due to the short-term maturities of these instruments.

 

Accounting Standards Codification ("ASC") Topic 820, “Fair Value Measurements and Disclosures,” requires disclosure of the fair value of financial instruments held by the Company. ASC Topic 825, “Financial Instruments,” defines fair value, and establishes a three-level valuation hierarchy for disclosures of fair value measurement that enhances disclosure requirements for fair value measures. The carrying amounts reported in the Condensed Consolidated Balance Sheetscondensed consolidated balance sheets for current liabilities qualify as financial instruments and are a reasonable estimate of their fair values because of the short period between the origination of such instruments and their expected realization and their current market rate of interest. The three levels of valuation hierarchy are defined as follows:

 

·Level 1. Observable inputs such as quoted prices in active markets;
·Level 2. Inputs, other than the quoted prices in active markets, that are observable either directly or indirectly; and
·Level 3. Unobservable inputs in which there is little or no market data, which require the reporting entity to develop its own assumptions.
Level 1. Observable inputs such as quoted prices in active markets;

 

Level 2. Inputs, other than the quoted prices in active markets, that are observable either directly or indirectly; and

The Company adopted ASC subtopic 820-10, Fair Value Measurements and Disclosures and ASC subtopic 825-10, Financial Instruments,

Level 3. Unobservable inputs in which permit entitiesthere is little or no market data, which require the reporting entity to choose to measure many financial instruments and certain other items at fair value. Neither of these statements had an impact on the Company's financial position, results of operations or cash flows. The carrying value of cash, accounts payable and accrued expenses, as reflected in the consolidated balance sheets, approximate fair value because of the short-term maturity of these instruments.

develop its own assumptions.

 

Income Taxes

 

Deferred taxes are calculated using the liability method whereby deferred tax assets are recognized for deductible temporary differences and operating loss and tax credit carry forwards, and deferred tax liabilities are recognized for taxable temporary differences. Temporary differences are the differences between the reported amounts of assets and liabilities and their tax bases. Deferred tax assets are reduced by a valuation allowance when, in the opinion of management, it is more likely than not that some portion or all the deferred tax assets will not be realized. Deferred tax assets and liabilities are adjusted for the effects of changes in tax laws and rates on the date of enactment.

 

A valuation allowance is provided for deferred income tax assets when, in management’s judgment, based upon currently available information and other factors, it is more likely than not that all or a portion of such deferred income tax assets will not be realized. The determination of the need for a valuation allowance is based on an on-going evaluation of current information including, among other things, historical operating results, estimates of future earnings in different taxing jurisdictions and the expected timing of the reversals of temporary differences. The Company believes the determination to record a valuation allowance to reduce a deferred income tax asset is a significant accounting estimate because it is based on, among other things, an estimate of future taxable income in the United StatesU.S. and certain other jurisdictions, thatwhich is susceptible to change and may or may not occur, and because the impact of adjusting a valuation allowance may be material. In determining when to release the valuation allowance established against the Company’s net deferred income tax assets, the Company considers all available evidence, both positive and negative. Consistent with the Company’s policy, and because of the Company’s history of operating losses, the Company does not currently recognize the benefit of all its deferred tax assets, including tax loss carry forwards, thatwhich may be used to offset future taxable income. The Company continually assesses its ability to generate sufficient taxable income during future periods in which deferred tax assets may be realized. When the Company believes it is more likely than not that it will recover its deferred tax assets, the Company will reverse the valuation allowance as an income tax benefit in the statements of operations.

 

 

 

 

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The U.S. GAAP method of accounting for uncertain tax positions utilizes a two-step approach to evaluate tax positions. Step one, recognition, requires evaluation of the tax position to determine if based solely on technical merits it is more likely than not to be sustained upon examination. Step two, measurement, is addressed only if a position is more likely than not to be sustained. In step two, the tax benefit is measured as the largest amount of benefit, determined on a cumulative probability basis, which is more likely than not to be realized upon ultimate settlement with tax authorities. If a position does not meet the more likely than not threshold for recognition in step one, no benefit is recorded until the first subsequent period in which the more likely than not standard is met, the issue is resolved with the taxing authority or the statute of limitations expires. Positions previously recognized are derecognized when the Company subsequently determines the position no longer is more likely than not to be sustained. Evaluation of tax positions, their technical merits and measurements using cumulative probability are highly subjective management estimates. Actual results could differ materially from these estimates.

 

On March 27, 2020, Congress enacted the “Coronavirus Aid, Relief and Economic Security ("CARES") Act” to provide certain relief as a result of the 2019 Coronavirus pandemic. The Company maintains a full valuation allowance on its U.S. net deferred tax assets. Deferred tax asset remeasurement (tax expense) was offset by a net decrease in valuation allowance, that resulted in no impact on the Company's income tax expense. Therefore, the Company does not expect the provisions in the CARES Act will impact the Company’s Condensed Consolidated Financial Statements.

Research and Development

 

Research and development (“R&D”) expenses consist of costs incurred for direct and overhead-related research expenses and are expensed as incurred. Costs to acquire technologies, including licenses, that are utilized in research and development and that have no alternative future use are expensed when incurred. Technology developed for use in the Company’s product candidates is expensed as incurred until technological feasibility has been established.

 

Under the Cannabis Licensing Agreement, entered into in December 2014, the Company acquired from Austrianova an exclusive, world-wide license to use the Cell-in-a-Box®trademark and its associated technology with genetically modified non-stem cell lines which are designed to convert Cannabinoids from cannabis to develop cancer therapies.

Under the Cannabis Licensing Agreement, the Company was required to pay Austrianova an upfront payment of $2.0 million in full by no later than June 30, 2016. The Company paid Austrianova $2.0 million in a timely manner. The cost of the license was recorded as research and development costs.

Research and development costsR&D expenses for the three and nine months ended JanuaryJuly 31, 20182020 and 20172019 were $802,565, $579,717, $1,745,692$270,574 and $1,008,489,$72,330, respectively.

 

Stock-Based Compensation

 

The Company recognizes stock-based compensation expense for only those awards ultimately expected to vest on a straight-line basis over the requisite service period of the award, net of an estimated forfeiture rate.award. The Company estimates the fair value of stock options using a Black-Scholes-Merton valuation model. This model which requires the input of highly subjective assumptions, including the option's expected term and stock price volatility. In addition, judgment is also required in estimating the number of stock-based awards that are expected to be forfeited. Forfeitures are estimated based on historical experience at the time of grant and revised, if necessary, in subsequent periods if actual forfeitures differ from those estimates. The assumptions used in calculating the fair value of share-based payment awards represent management's best estimates, but these estimates involve inherent uncertainties and the application of management's judgment. Thus, if factors change and the Company uses different assumptions, itsthe stock-based compensation expense could be materially different in the future.

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Concentration of Credit Risk

 

The Company has no significant off-balance-sheet concentrations of credit risk such as foreign exchange contracts, options contracts or other foreign hedging arrangements. The Company maintains most of its cash balance at a financial institution located in California. Accounts at this institution are insured by the Federal Deposit Insurance Corporation up to $250,000. Uninsured balances aggregated approximately $1,258,000$1,887,000 and $3,214,000$618,000 at JanuaryJuly 31, 20182020 and April 30, 2017,2020, respectively. The Company has not experienced any losses in such accounts. Management believes it is not exposed to any significant credit risk on cash.

 

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Foreign Currency Translation

 

The Company translates the financial statements of its foreign subsidiarysubsidiaries from the local (functional) currencies to U.S. dollars in accordance with FASB ASC 830,Foreign Currency Matters. All assets and liabilities of the Company’s foreign subsidiaries are translated at year-endperiod-end exchange rates, while revenue and expenses are translated at average exchange rates prevailing during the year.period. Adjustments for foreign currency translation fluctuations are excluded from net loss and are included in other comprehensive income. Gains and losses on short-term intercompany foreign currency transactions are recognized as incurred.

 

Going Concern

The accompanying Condensed Consolidated Financial Statements have been prepared assuming that the Company will continue as a going concern; however, the following conditions raise substantial doubt about the Company's ability to do so.   As of July 31, 2020, the Company has an accumulated deficit of $104,742,203 and incurred a net loss for three months ended July 31, 2020 of $883,944. The Company requires substantial additional capital to finance its planned business operations and expects to incur operating losses in future periods due to the expenses related to the Company’s core businesses. The Company has not realized any revenue since it commenced doing business in the biotechnology sector, and there can be no assurance that it will be successful in generating revenues in the future in this sector. The Condensed Consolidated Financial Statements do not include any adjustments to reflect the possible future effects on the recoverability and classification of assets or the amounts and classifications of liabilities that may result should the Company be unable to continue as a going concern.

For the three months ended July 31, 2020, funding was provided by investors to maintain and expand the Company’s operations. Sales of the Company’s common stock were made under an operative Form S-3 (“S-3”) allowing for offerings of up to $50 million dollars in transactions that are deemed to be “at the market offerings” as defined in Rule 415 under the Securities Act or transactions structured as a public offering of a distinct block or blocks of the shares of the Company’s common stock. During the three months ended July 31, 2020, the Company continued to acquire funds through the Company’s S-3 pursuant to which the placement agent sells shares of common stock “at-the-market” in a program which is structured to provide up to $25 million to the Company less certain commissions pursuant to the S-3. From May 1, 2020 through July 31, 2020 the Company raised capital of approximately $1.9 million in Block Trade transactions and “at-the-market” transactions.

From August 1, 2020 through August 12, 2020, the Company raised capital of approximately $2.8 million in Block Trades net of commissions.

On August 13, 2020, the Company no longer met the eligibility requirements to use the S-3 to raise capital, and the Company ceased to use the S-3 to raise capital after that date.

Management determined that its plans to raise additional capital alleviate substantial doubt about the Company’s ability to continue as a going concern. The Company believes the cash on hand, the potential sales of unregistered shares of its common stock and any public offerings of common stock in which the Company may engage in will provide sufficient capital to meet the Company’s capital requirements and to fund the Company’s operations through September 30, 2021.

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Recent Accounting Pronouncements

 

In May 2014, the FASB issued Accounting Standards Update (“ASU”) No. 2014-09 "Revenue from Contracts with Customers" (“Topic 606”). Topic 606 supersedes the revenue recognition requirements in Topic 605,“Revenue Recognition,” including most industry-specific revenue recognition guidance throughout the Industry Topics of the Codification. In addition, the amendments create a new Subtopic 340-40,“Other Assets and Deferred Costs—Contracts with Customers.” In summary, the core principle of Topic 606 is that an entity recognizes revenue to depict the transfer of promised goods or services to customers in an amount that reflects the consideration to which the entity expects to be entitled in exchange for those goods or services. For a public entity, the amendments in this ASU are effective for annual reporting periods beginning after December 15, 2017, including interim periods within that reporting period; early application is not permitted. The Company is not currently generating revenue; therefore, it does not expect there will be an impact from this guidance on the Company’s consolidated financial position and consolidated statement of operations.

ASU No. 2016-02,Leases, allows the recognition of lease assets and lease liabilities by lessees for those leases classified as operating leases under previous U.S. GAAP. The classification criteria for distinguishing between finance leases and operating leases are similar to the classification criteria for distinguishing between capital leases and operating leases in the previous leases guidance. The Update 2016-02 is effective for annual reporting periods beginning after December 15, 2018 and early adoption is permitted. The Company is still evaluating the effect of this update.

The Company does not anticipate any material impact on its consolidated financial statements upon the adoption of the following accounting pronouncements issued: (i) ASU No. 2016-01,Financial Instruments - Overall (Subtopic 825-10): Recognition and Measurement of Financial Assets and Financial Liabilities; (ii) ASU No. 2016-13,Financial Instruments - Credit Losses (Topic 326): Measurement of Credit Losses on Financial Instruments;Instruments (iii) ("ASU 2016-13"), was issued in June 2016. Under ASU 2016-13, existing guidance on reporting credit losses for trade and other receivables and available for sale debt securities will be replaced with a new forward-looking "expected loss" model that generally will result in the earlier recognition of allowances for losses. The Company’s adoption of ASU 2016-13 during the quarter ended July 31, 2020 did not result in an impact on the Company’s Condensed Consolidated Financial Statements.

ASU No. 2017-07,2019-12, Compensation - Retirement Benefits (Topic 715): ImprovingSimplifying the PresentationAccounting for Income Taxes ("ASU 2019-12"), was issued in December 2019. Under ASU 2019-12, the accounting for income taxes is simplified by eliminating certain exceptions and implementing additional requirements which result in a more consistent application of Net Periodic Pension CostASC 740. The Company is currently in the process of evaluating the impact of adopting ASU 2019-12 in 2021, but it does not expect it to have a material impact on the Company’s Condensed Consolidated Financial Statements.

NOTE 3 – ACCRUED EXPENSES

Accrued expenses at July 31, 2020 and Net Periodic Postretirement Benefit Cost;April 30, 2020 are summarized below:

  July 31, 2020  April 30, 2020 
Payroll related costs $443,906  $435,577 
Director and Officer insurance financing  75,908   113,245 
Other  207,004   267,816 
Total $726,818  $816,638 

The Company financed the Director and (iv) ASU No. 2017-09,Compensation-Stock Compensation (Topic 718): ScopeOfficer insurance policy. The term of Modification Accounting.the policy is from March 8, 2020 through March 8, 2021. The financing agreement has an interest rate of 4.25% per annum and requires eight monthly payments of $12,806. The unpaid balances as of July 31, 2020 and April 30, 2020 are $75,908 and $113,245, respectively, are included in accrued expenses.

 

NOTE 4 – BINDING TERM SHEET AGREEMENT OBLIGATIONSMALL BUSINESS ADMINISTRATION – PAYCHECK PROTECTION PROGRAM

 

On March 27, 2020, the CARES Act was enacted to provide financial aid to family and businesses impacted by the COVID-19 pandemic.  The Company participated in the CARES Act, and on April 15, 2020, the Company entered into a Binding Term Sheetnote payable with a bank under the Small Business Administration (“Term Sheet”SBA”) Paycheck Protection Program (“PPP loan”) in the amount of $75,200. This loan payable matures on April 15, 2022 with SG Austriaa fixed interest rate of 1% per annum with interest deferred for six months. The PPP loan has an initial term of two years, is unsecured and Austrianova pursuant to whichguaranteed by the parties reached an agreement to amend certain provisionsSBA. Under the terms of the APA,PPP loan, the Diabetes Licensing Agreement andCompany may apply for forgiveness of the Cannabis Licensing Agreement.amount due on the PPP loan. The Term Sheet statesCompany used the proceeds from the PPP loan for qualifying expenses as defined in the PPP. The Company intends to apply for forgiveness of the PPP loan in accordance with the terms of the CARES Act. However, the Company cannot assure at this time that the CompanyPPP loan will pay Austrianova periodic payments totaling $900,000 upon execution ofbe forgiven partially or in full. If the amendments requiredloan is not forgiven based on the PPP guidelines to be issued by the Term Sheet. AsSBA, as defined, then, the monthly payment amount will be $4,229 beginning on October 15, 2020 through April 15, 2022. The PPP loan balance as of JanuaryJuly 31, 2018, the amendments to the APA, the Diabetes Licensing Agreement2020 and Cannabis Licensing Agreement to be entered into pursuant to the Term Sheet have not been finalized. The terms have been generally agreed to and the Company has made payments totaling $600,000. As of January 31, 2018, the Company’s obligation under the Term Sheet is $300,000. (See Note 10).April 30, 2020 was $75,200.

NOTE 5 – PREFERRED STOCK

The Company has authorized 10,000,000 shares of preferred stock, with a par value of $0.0001, of which 13,500 shares have been designated as “Series E Convertible Preferred Stock.” There are no outstanding shares of preferred stock or Series E Convertible Preferred Stock. The Series E Convertible Preferred Stock has the following features:

·The holders of Series E Convertible Preferred Stock are entitled to receive cash out of the assets of the Company before any amount is paid to the holders of any capital stock of the Company of any class junior in rank to the shares of Series E Convertible Preferred Stock;
·Each share of Series E Convertible Preferred Stock is convertible, at the holder’s option, into shares of common stock at the average closing bid price of the common stock for five trading days prior to the conversion date;
·The Company has the right, in its sole discretion, at any time 110 days after issuance of shares of Series E Convertible Preferred Stock, to redeem all the shares of Series E Convertible Preferred Stock upon thirty days advance written notice at a redemption price equal to the par value of the shares of the Series E Convertible Preferred Stock; and
·At every meeting of stockholders every holder of shares of Series E Convertible Preferred Stock is entitled to 50,000 votes for each share of Series E Convertible Preferred Stock with the same and identical voting rights as a holder of a share of common stock.

 

 

 

 

 1416 

 

 

NOTE 65 – COMMON STOCK TRANSACTIONS

 

A summary of the Company’s non-vested restrictedcompensatory stock activity and related weighted average grant date fair value information for the three and nine months ended JanuaryJuly 31, 20182020 and 2017 are2019 is as follows:

 

TheDuring the three months ended July 31, 2019, the Company awarded 3,600,000issued 2,000,000 shares of common stock to officers as partfour non-employee members of their compensation agreementsthe Company’s Board of Directors (“Board”) pursuant to Director Letter Agreements (“DLAs”) with the Company for 2016. Theseservices relating to the prior year. The shares vest on a quarterly basis over a twelve-month period and are subject to their continuing service under the agreements. During the three and nine months ended January 31, 2017, 600,000 and 2,400,000 shares vested upon issuance and the Company recorded a non-cash compensation expense inof $0 and $13,804 for the amount of $35,940three months ended July 31, 2020 and $143,760,2019, respectively. There were no unvested shares as of January 31, 2018.

 

The Company awarded 1,200,000 shares of common stock to an employee as part of his compensation agreement for 2016. These shares vest on a quarterly basis over a twelve-month period and are subject to the employee providing services under the agreement. During the three and nine months ended January 31, 2017, 200,000 and 800,000 shares vested and the Company recorded a non-cash compensation expense in the amount of $11,980 and $47,920, respectively. There were no unvested shares as of January 31, 2018.

During the nine months ended January 31, 2017,Effective July 1, 2018, the Company issued 600,0001,200,000 shares of common stock to a consultant. TheseThe term of the agreement is for twelve months. The shares vest on a quarterly basismonthly over a twelve-month period and are subject to the consultant providing services under the agreement. During the three and nine months ended January 31, 2017, 150,000 and 450,000 shares vested and theThe Company recorded a non-cash consulting expense in the amount of $8,550$0 and $26,650,$12,816 for the three months ended July 31, 2020 and 2019, respectively. There were nozero unvested shares as of JanuaryJuly 31, 2018.2020 and 2019, respectively.

 

During the nine months ended January 31, 2017, the Companymonth of April 2019, two consultants were issued 500,0002,500,000 shares of common stock pursuant to two consultants.their consulting agreements. The termsterm of the agreements areis for twelve months each.which covered prior and current periods. The shares vested upon issuancevest monthly over a twelve-month period and are subject to the consultant providing services under their respective consulting agreements. The Company recorded a non-cash consulting expense in the amount of $21,400$0 and $21,400$7,209 for the three and nine months ended JanuaryJuly 31, 2017.2020 and 2019, respectively. There were nozero and 83,333 unvested shares as of JanuaryJuly 31, 2018.2020 and 2019, respectively.

 

During the ninethree months ended JanuaryJuly 31, 2017, the Company issued 750,0002019, a consultant was owed 500,000 shares of Common Stockcommon stock pursuant to two consultants.his consulting agreement with the Company. The termsterm of the agreements areconsulting agreement is for twelve months each.which covered prior and current periods. The shares vested upon issuancevest monthly over a twelve-month period and are subject to the consultant providing services under his consulting agreement. The Company recorded a non-cash compensationconsulting expense in the amount of $25,900$0 and $3,306 for the ninethree months ended JanuaryJuly 31, 2017. There were no unvested2020 and 2019, respectively. As of July 31, 2020 and 2019, zero and 500,000 shares as of January 31, 2018.remained unissued, respectively.

 

The Company awarded 6,600,000 shares of common stock to officers as part of their compensation agreements for 2017.2019. These shares vest monthly over a twelve-month period and are subject to them continuing service under the agreements. During the three and nine months ended JanuaryJuly 31, 2018,2020 and 2019, the Company recorded a non-cash compensation expense in the amount of $114,400$0 and $457,600,$104,726, respectively. AsThere were zero and 2,750,000 unvested shares as of JanuaryJuly 31, 2018, there were no unvested shares.2020 and 2019, respectively.

 

During the ninethree months ended JanuaryJuly 31, 2018,2019, three non-employee members of the CompanyBoard were issued 1,750,0001,500,000 shares of common stock pursuant to four directorstheir DLAs with the Company. The shares were fully vested upon issuance. The Company recorded a non-cash expense of $7,356 and $11,642 for the three months ended July 31, 2020 and 2019, respectively. There were zero unvested shares of Common Stock remaining related to these DLAs as of July 31, 2020 and 2019.

During the three months ended July 31, 2019, a consultant was issued 2,000,000 shares of common stock in respect of his services as the Chairman of the Company’s Medical and Scientific Advisory Board over a four-year period with their vesting subject to the consultant providing services to the Company. The Company recorded a non-cash consulting expense in the amount of Directors (“Board”)$0 and $7,150 for the three months ended July 31, 2020 and 2019, respectively. There were zero unvested shares remaining related to these compensation agreements as of July 31, 2020 and 2019.

During the three months ended July 31, 2020, three non-employee members of the Board were issued 1,500,000 shares of Common Stock pursuant to Board compensation agreements.their DLAs in respect of their service during that year. The shares were fully vested upon issuance. The Company recorded a non-cash expense of $7,029 and $0 for the three months ended July 31, 2020 and 2019, respectively. There were zero unvested shares remaining related to a DLA as of July 31, 2020.

17

During the three months ended July 31, 2020, four consultants were issued 1,000,000 shares of restricted Common Stock pursuant to their respective consulting agreement with the Company. The terms of the agreements are for twelve months. The shares vested upon issuance and the Company recorded a non-cash expense of $25,038 and $50,947 for the three and nine months ended January 31, 2018, respectively.

During the nine months ended January 31, 2018, the Company issued 4,200,000 shares of common stock to three consultants. The terms of two of the agreements are for twelve months and one agreement is for eighteen months. The shares vest monthly over a twelve-month to eighteen-month period and are subject to the consultants providing services under the agreements.consultant’s respective consulting agreement. The Company recorded a non-cash consulting expense in the amount of $69,840$4,199 and $150,630$0 for the three and nine months ended JanuaryJuly 31, 2018,2020 and 2019, respectively. AsThere were 750,000 unvested shares remaining related to these consulting agreements as of JanuaryJuly 31, 2018, there were 2,100,000 unvested shares.2020.

 

TheIn January 2020, the Company awarded 6,600,000 shares of common stock to officers as part of their compensation agreements for 2018.agreements. These shares vest monthly over a twelve-month period and are subject to them continuing service under the agreements. During the three and nine months ended JanuaryJuly 31, 2018,2020, the Company recorded a non-cash compensation expense in the amount of $30,690 and $30,690, respectively. As$67,320. There were 2,750,000 unvested shares as of JanuaryJuly 31, 2018, there were 6,050,000 unvested shares.2020.

 

All shares listed above were issued without registration under the Securities Act of 1933, as amended (“Securities Act”) in reliance upon the exemption afforded by Section 4(a)(2) of the Securities Act.

  

15

During the ninethree months ended JanuaryJuly 31, 20182020 and 2017,2019, the Company sold and issued approximately 62.4234 million and 89.266.7 million shares of common stock, respectively, at prices ranging from $0.02approximately $0.01 to $0.16$0.03 per share.share pursuant to the Company’s S-3. Net of underwriting discounts, legal, accounting and other offering expenses, the Company received net proceeds of approximately $1.75 million$1,857,000 and $3.1 million$558,000 from the sale of these shares for the ninethree months ended JanuaryJuly 31, 20182020 and 2017,2019, respectively.

 

A summary of the Company’s non-vestedunvested restricted stock activity and related weighted average grant date fair value information for the ninethree months ended JanuaryJuly 31, 20182020 are as follows:

 

   Shares  Weighted
Average
Grant Date
Fair Value
 
        
 Non-vested, at April 30, 2017   4,400,000  $0.10 
           
 Granted   12,550,000   0.06 
           
 Vested   (8,800,000)  0.08 
           
 Forfeited       
           
 Non-vested, at January 31, 2018   8,150,000  $0.06 
  Shares  Weighted
Average
Grant Date
Fair Value
 
       
Unvested, at April 30, 2020  4,600,000  $0.06 
Granted  2,500,000   0.02 
Vested  (3,600,000)  0.03 
Forfeited      
         
Unvested, at July 31, 2020  3,500,000  $0.04 

 

NOTE 76 – STOCK OPTIONS AND WARRANTS

 

Stock Options

 

As of JanuaryJuly 31, 2018,2020, the Company had 95,250,00068,700,000 outstanding stock options to its directors and officers (collectively, “Employee Options”) and consultants (“Non-Employee Options”).

 

During the ninethree months ended JanuaryJuly 31, 20182020 and 2017,2019, the Company granted 16,150,0001,500,000 and 01,500,000 Employee Options, respectively.

18

 

The fair value of the Employee Options at the date of grant was estimated using the Black-Scholes-Merton option-pricing model, based on the following weighted average assumptions:

 

 Nine Months Ended January 31,  Three Months Ended July 31, 
 2018 2017  2020  2019 
Risk-free interest rate  2.0%      0.3%  2.1%
Expected volatility  107%      91%  91%
Expected lives (years)  2.8    
Expected term (years)  2.5   2.5 
Expected dividend yield  0.00%      0.00%  0.00%

 

During the nine months ended January 31, 2018 and 2017, the Company granted Non-Employee Options of 4,200,000 and 13,100,000, respectively. The Non-Employee Options granted during the nine months ended January 31, 2017 consisted of 600,000 guaranteed options and 12,500,000 non-guaranteed performance based options. The 12,500,000 non-guaranteed performance based options expired on April 30, 2017.

16

The fair value of the Non-Employee Options was estimated using the Black-Scholes-Merton option-pricing model, based on the following weighted average assumptions:

  Nine Months Ended January 31, 
  2018  2017 
Risk-free interest rate  2.5%   1.8% 
Expected volatility  106%   110% 
Expected lives (years)  4.3   5.0 
Expected dividend yield  0.00%   0.00% 

The Company’s computation of expected volatility is based on the historical daily volatility of its publicly traded stock. For stock option grants issued during the ninethree months ended JanuaryJuly 31, 20182020 and 2017,2019, the Company used a calculated volatility for each grant. The Company lacks adequate information about the exercise behavior now and has determined the expected term assumption under the simplified method provided for under ASC 718, which averages the contractual term of the Company’s stock options of five years with the average vesting term of two and one-half years for an average of three years. The dividend yield assumption of zero is based upon the fact the Company has never paid cash dividends and presently has no intention of paying cash dividends. The risk-free interest rate used for each grant is equal to the United StatesU.S. Treasury rates in effect at the time of the grant for instruments with a similar expected life.

 

During the three months ended July 31, 2020 and 2019, the Company granted no Non-Employee Option grants that do not vest immediately upon grant are recorded as an expense over the vesting period. At the end of each financial reporting period, the value of these options, as calculated using the Black-Scholes-Merton option-pricing model, is determined, and compensation expense recognized or recovered during the period is adjusted accordingly. As a result, the amount of the future compensation expense is subject to adjustment until the Non-Employee Options are fully vested.Options.

 

A summary of the Company’s stock option activity and related information for the ninethree months ended JanuaryJuly 31, 2018 are2020 is shown below:

 

 Options Weighted
Average
Exercise Price
 Weighted
Average
Grant Date
Fair Value
per Share
  Options  Weighted
Average
Exercise Price
  Weighted
Average
Grant Date
Fair Value
per Share
 
              
Outstanding, April 30, 2017  79,100,000  $0.13  $0.09 
Outstanding, April 30, 2020  67,200,000  $0.06  $0.06 
Issued  16,150,000   0.06   0.06   1,500,000   0.02   0.02 
Forfeited                  
Exercised                  
Outstanding, January 31, 2018  95,250,000  $0.11  $0.11 
Exercisable, January 31, 2018  84,500,000  $0.12  $ 
Outstanding, July 31, 2020  68,700,000  $0.06  $0.06 
Exercisable, July 31, 2020  64,950,000  $0.06  $ 
Vested and expected to vest  95,250,000  $0.11  $   68,700,000  $0.06  $ 

  

A summary of the activity for unvested stock options during the ninethree months ended JanuaryJuly 31, 20182020 is as follows:

 

   Options  Weighted
Average
Grant Date
Fair Value
per Share
 
        
 Non-vested, April 30, 2017   6,800,000  $0.10 
 Granted   16,150,000   0.06 
 Vested   (12,200,000)  0.09 
 Forfeited       
 Non-vested, January 31, 2018   10,750,000  $0.06 
  Options  Weighted
Average
Grant Date
Fair Value
per Share
 
       
Unvested, April 30, 2020  6,200,000  $0.05 
Granted  1,500,000   0.02 
Vested  (3,950,000)   
Forfeited      
Unvested, July 31, 2020  3,750,000  $0.03 

 

 

 

 1719 

 

 

The Company recorded approximately $220,000$72,317 and $110,000$116,914 of stock basedstock-based compensation related to the issuance of Employee Options to certain officers and directors in exchange for services during the three months ended JanuaryJuly 31, 20182020 and 2017, respectively, and approximately $612,000 and $438,000 during the nine months ended January 31, 2018 and 2017,2019, respectively. At JanuaryJuly 31, 2018,2020, there remained approximately $362,000$88,526 of unrecognized compensation expense related to unvested Employee Options granted to officers and directors, to be recognized as expense over a weighted-average period of the remaining 11 months.five months in the calendar year. The non-vestedunvested options vest at 850,000750,000 shares per month and are expected to be fully vested on December 31, 2018.2020.

 

The Company recorded approximately $57,000$0 and $6,000$9,411 of stock basedstock-based compensation related to the issuance of Non-Employee Options in exchange for services during the three months ended JanuaryJuly 31, 20182020 and 2017, respectively, and approximately $154,000 and $18,000 during the nine months ended January 31, 2018 and 2017,2019, respectively. The non-vestedThere were no unvested Non-Employee Options vest at 400,000 shares per month and are expected to be fully vested on DecemberJuly 31, 2018.2020.

 

The following table summarizes ranges ofthe outstanding stock options by exercise price at JanuaryJuly 31, 2018:2020:

 

Exercise PriceExercise Price Number of Options Outstanding Weighted Average Remaining Contractual Life (years) of Outstanding Options Weighted Average Exercisable Price Number of Options Exercisable Weighted Average Exercise Price of Exercisable Options Exercise Price Number of
Options
Outstanding
 Weighted
Average
Remaining
Contractual Life
of Outstanding
Options
(years)
 Weighted
Average
Exercisable
Price
 Number of
Options
Exercisable
 Weighted Average
Exercise Price
of Exercisable
Options
 
$0.19   25,000,000   0.83  $0.19   25,000,000  $0.19 0.063   15,600,000   0.25  $0.063   15,600,000  $0.063 
$0.11   27,200,000   1.01  $0.11   27,200,000  $0.11 0.104 10,450,000 1.03 $0.104 10,450,000 $0.104 
$0.18   250,000   1.11  $0.18   250,000  $0.18 0.0685 600,000 0.75 $0.0685 600,000 $0.0685 
$0.06   15,600,000   1.75  $0.06   15,600,000  $0.06 0.058 2,450,000 1.43 $0.058 2,450,000 $0.058 
$0.10   10,450,000   2.63  $0.10   10,350,000  $0.10 0.0734 1,200,000 0.96 $0.0734 1,200,000 $0.0734 
$0.07   600,000   3.25  $0.07   600,000  $0.07 0.0729 1,800,000 1.94 $0.0729 1,800,000 $0.0729 
$0.06   1,250,000   2.21  $0.06   1,250,000  $0.06 0.089 1,200,000 1.96 $0.089 1,200,000 $0.089 
$0.06   1,200,000   4.42  $0.06   700,000  $0.06 0.0553 500,000 1.10 $0.0553 500,000 $0.0553 
$0.07   1,200,000   4.25  $0.07   900,000  $0.07 0.0558 9,000,000 1.45 $0.0558 9,000,000 $0.0558 
$0.07   1,800,000   4.44  $0.07   700,000  $0.07 0.0534 1,200,000 3.10 $0.0534 1,200,000 $0.0534 
$0.09   1,200,000   2.23  $0.09   700,000  $0.09 0.0539 1,000,000 1.38 $0.0539 1,000,000 $0.0539 
$0.06   500,000   2.35  $0.06   500,000  $0.06 0.0683 500,000 1.46 $0.0683 500,000 $0.0683 
$0.06   9,000,000   2.95  $0.06   750,000  $0.06 0.0649 500,000 1.60 $0.0649 500,000 $0.0649 
Total   95,250,000   1.68  $0.11   84,500,000  $0.12 
$0.0495 9,000,000 1.88 $0.0495 9,000,000 $0.0495 
$0.0380 1,200,000 4.15 $0.0380 1,200,000 $0.0380 
$0.0404 1,000,000 1.88 $0.0404 1,000,000 $0.0404 
$0.0370 500,000 1.96 $0.0370 500,000 $0.0370 
$0.0340 500,000 2.10 $0.0340 500,000 $0.0340 
$0.0408 9,000,000 2.66 $0.0408 5,250,000 $0.0408 
$0.0240 1,000,000 2.38 $0.0240 1,000,000 $0.0240 
$0.0247  500,000 2.46 $0.0247  500,000 $0.0247 
Total  68,700,000 1.47 $0.06  64,950,000 $0.06 

 

As of January 31, 2018, theThe aggregate intrinsic value of outstanding options as of July 31, 2020 was $188,360.zero. This represents options whose exercise price was less than the closing fair market value of the Company’s common stock on JanuaryJuly 31, 20182020 of approximately $0.07$0.014 per share.

20

 

Warrants

 

The warrants issued by the Company are classified as equity.equity-classified. The fair value of the warrants was recorded as additional-paid-in-capital,additional paid-in-capital, and no further adjustments are made.

 

For stock warrants paid in consideration of services rendered by non-employees, the Company recognizes consulting expense in accordance with the requirements of ASC 505-50 and ASC 505.

 

Effective May 24, 2017,June 13, 2019, the Company issued a common stock purchase warrantCommon Stock Purchase Warrant to the placement agent of the Company’s at-the-market and block trade offerings.Aeon Capital, Inc. (“Aeon”) for a Block Trade transaction. The Company issued a warrant to purchase 833,3331,338,889 shares of common stock based upon a block tradethe Block Trade transaction pursuant to the amendedCompany’s engagement agreement with Aeon dated May 19, 2017 with the Company’s placement agent.February 22, 2018 (“Aeon Engagement Agreement”). The Company classified these warrants as equity, and theequity. The warrants have a term of five years with an exercise price of approximately $0.03$0.01 per warrant share. Using the Black-Scholes-Merton warrantoption pricing model, the Company determined the aggregate fair value of these warrants to be approximately $20,000.$9,000. The warrants have a cashless exercise feature.

 

18

Effective July 26, 2017,15, 2019, the Company issued a common stock purchase warrantCommon Stock Purchase Warrant to the placement agent of the Company’s at-the-market and block trade sales.Aeon for a Block Trade transaction. The Company issued a warrant to purchase 2,000,0001,944,444 shares of common stock based upon a block tradethe Block Trade pursuant to the amended engagement agreement dated June 28, 2017 with the Company’s placement agent.Aeon Engagement Agreement. The Company classified these warrants as equity, and theequity. The warrants have a term of five years with an exercise price of approximately $0.03$0.01 per warrant share. Using the Black-Scholes-Merton warrantoption pricing model, the Company determined the aggregate fair value of these warrants to be approximately $23,000.$12,000. The warrants have a cashless exercise feature.

Effective July 10, 2020, the Company issued a Common Stock Purchase Warrant to Aeon for a Block Trade transaction. The Company issued a warrant to purchase 4,100,000 shares of common stock based upon the Block Trade pursuant to the Aeon Engagement Agreement. The Company classified these warrants as equity. The warrants have a term of five years with an exercise price of $0.01 per warrant share. Using the Black-Scholes-Merton option pricing model, the Company determined the aggregate fair value of these warrants to be approximately $29,000. The warrants have a cashless exercise feature.

Effective July 18, 2020, the Company issued a Common Stock Purchase Warrant to Aeon for a Block Trade transaction. The Company issued a warrant to purchase 3,500,000 shares of common stock based upon the Block Trade pursuant to the Aeon Engagement Agreement. The Company classified these warrants as equity. The warrants have a term of five years with an exercise price of approximately $0.01 per warrant share. Using the Black-Scholes-Merton option pricing model, the Company determined the aggregate fair value of these warrants to be approximately $18,000. The warrants have a cashless exercise feature.

Effective July 19, 2020, the Company issued a Common Stock Purchase Warrant to Aeon for a Block Trade transaction. The Company issued a warrant to purchase 1,333,333 shares of common stock based upon the Block Trade pursuant to the Aeon Engagement Agreement. The Company classified these warrants as equity. The warrants have a term of five years with an exercise price of approximately $0.01 per warrant share. Using the Black-Scholes-Merton option pricing model, the Company determined the aggregate fair value of these warrants to be approximately $7,000. The warrants have a cashless exercise feature.

Effective July 27, 2020, the Company issued a Common Stock Purchase Warrant to Aeon for a Block Trade transaction. The Company issued a warrant to purchase 2,500,000 shares of common stock based upon the Block Trade pursuant to the Aeon Engagement Agreement. The Company classified these warrants as equity. The warrants have a term of five years with an exercise price of approximately $0.01 per warrant share. Using the Black-Scholes-Merton option pricing model, the Company determined the aggregate fair value of these warrants to be approximately $13,000. The warrants have a cashless exercise feature.

21

 

A summary of the Company’s warrant activity and related information for the ninethree months ended JanuaryJuly 31, 2018 are2020 is shown below:

 

   Warrants  Weighted
Average
Exercise Price
 
 Outstanding, April 30, 2017   67,853,504  $0.13 
 Issued   2,833,333   0.03 
 Expired   (21,836,640)   
 Outstanding, January 31, 2018   48,850,197   0.12 
 Exercisable, January 31, 2018   48,850,197  $0.12 
  Warrants  Weighted
Average
Exercise Price
 
Outstanding, April 30, 2020  47,890,155  $0.05 
Issued  11,433,333   0.01 
Expired      
Outstanding, July 31, 2020  59,323,488   0.04 
Exercisable, July 31, 2020  59,323,488  $0.04 

  

The following table summarizes additional information concerning warrants outstanding and exercisable at JanuaryJuly 31, 2018:2020:

 

Exercise Prices Number of
Warrant Shares
Exercisable at January 31, 2018
  Weighted
Average
Remaining
Contractual
Life
  Weighted
Average
Exercise Price
 
$0.025, $0.03, $0.0575, $0.065, $0.11, $0.12 and $0.18  48,850,197   1.93  $0.12 
             
Five Year Term   –   $0.12  25,841,188   2.03     
Five Year Term   –   $0.18  8,536,880   0.15     
Five Year Term   –   $0.11  10,000,000   2.14     
Five Year Term   –   $0.065  769,231   3.92     
Five Year Term   –   $0.0575  869,565   4.18     
Five Year Term   –   $0.03  833,333   4.31     
Five Year Term   –   $0.025  2,000,000   4.44     
   48,850,197         
Exercise Prices Number of
Warrant Shares
Exercisable at
April 30, 2020
  Weighted
Average
Remaining
Contractual
Life
  Weighted
Average
Exercise Price
 
          
$0.12  17,000,000   0.44     
$0.065  769,231   1.39     
$0.0575  869,565   1.68     
$0.03  2,500,000   2.32     
$0.026  1,923,077   2.91     
$0.025  2,000,000   1.99     
$0.018  1,388,889   2.83     
$0.011  2,272,727   3.25     
$0.01  9,100,000   4.52     
$0.015  833,333   4.72     
$0.009  3,333,333   3.92     
$0.0075  7,333,333   4.97     
$0.005  10,000,000   4.41     
   59,323,488   2.96  $0.04 

 

NOTE 87 – LEGAL PROCEEDINGS

 

The Company is not currently a party to any pending legal proceedings, material or otherwise. There are no legal proceedings to which any property of the Company is subject. However, in the past the Company has been the subject of litigation, claims and assessments arising out of matters occurring in its normal business operations. In the opinion of management, none of these had a material adverse effect on the Company’s consolidated financial position, operations and cash flows.

 

NOTE 98 – RELATED PARTY TRANSACTIONS

 

The Company had the following related party transactions during the three and nine months ended JanuaryJuly 31, 20182020 and 2017, respectively.2019.

22

 

The Company owns 14.5% of the equity in SG Austria and is reported on the cost method of accounting. SG Austria has two subsidiaries: (i) Austrianova; and (ii) Austrianova Thailand Co.,Pte Ltd. The Company purchased products and services from these subsidiaries in the approximate amounts of $317,000$64,000 and $372,000$2,400 in the three months ended JanuaryJuly 31, 20182020 and 2017, respectively, and approximately $959,000 and $517,000 in the nine months ended January 31, 2018 and 2017,2019, respectively.

 

19

In April 2014, the Company entered a consulting agreement withthe Vin-de-Bona Trading Private Limited (“Vin-de-Bona”)Consulting Agreement pursuant to which it agreed to provide professional consulting services to the Company. Vin-de-Bona is owned by Prof. Walter H. Günzburg (“Prof. Günzburg) and Dr. Brian Salmons (“Dr. Salmons”), both of whom are involved in numerous aspects of the Company’s scientific endeavors relating to cancer and diabetes.diabetes (Prof. Gunzburg is the Chairman of Austrianova, and Dr. Salmons is the Chief Executive Officer and President of Austrianova). The term of the agreement is for 12 months, automatically renewable for successive 12-month terms. After the initial term, either party can terminate the agreement by giving the other party 30 days’ written notice before the effective date of termination. The agreement has been automatically renewed annually. The amounts paid for the nine months ended January 31, 2018 and 2017 were approximately $27,000 and $69,000 respectively, and approximately zero and $27,000incurred for the three months ended JanuaryJuly 31, 20182020 and 2017,2019 were approximately $13,000 and $13,000, respectively. Also,In addition, during the ninethree months ended JanuaryJuly 31, 2018 and 2017,2020 the Company awardedissued 250,000 shares of restricted common stock to Dr. SalmonsSalmons. The Company recorded a noncash consulting expense of approximately $8,000 relating to these share issuances for services in the amountthree months ended July 31, 2020.

During the year ended April 30, 2020, the Company issued one share of 250,000 and 250,000, respectively, and Dr. Günzburg earned 500,000 sharesSeries A Preferred Stock to the Chief Executive Officer of the Company’s restricted common stockCompany for $1 pursuant to a Subscription Agreement. The Series A Preferred Stock is described in detail in Note 12 – Preferred Stock. The Board exercised its right to have the nine months ended January 31, 2018.Company redeem the one share of Series A Preferred Stock. It is no longer issued and outstanding.

 

NOTE 109 – COMMITMENTS AND CONTINGENCIES

 

The Company acquires assets still in development and enters research and developmentR&D arrangements with third parties that often require milestone and royalty payments to the third-party contingent upon the occurrence of certain future events linked to the success of the asset in development. Milestone payments may be required, contingent upon the successful achievement of an important point in the development life-cyclelifecycle of the pharmaceutical product (e.g., approval of the product for marketing by a regulatory agency). If required by the license agreements, the Company may have to make royalty payments based upon a percentage of the sales of the pharmaceutical productsproduct if regulatory approval for marketing of the product candidate is obtained.

 

Office Lease

 

The Company formerly leased office space at 12510 Prosperity Drive, Suite 310, Silver Spring, Maryland 20904. The term of the lease expired on July 31, 2016 and was extended to August 31, 2016 at the same amount of monthly rent.

Effective September 1, 2016,2017, the Company entered into a newan office lease for office space at 23046 Avenida de la Carlota, Suite 600, Laguna Hills, California 92653 (“Leased Premises”). The term of the lease is for 12 months.24 months and expired on August 31, 2019. In May 2017,2019, the Company entered into an additional two-yearone-year lease for the Leased Premises, commencing upon the expiration of the term of the firstprior lease. The term of the lease expires on August 31, 2020.

On May 28, 2020, the Company entered into an additional six-month lease of the Leased Premises, commencing on September 1, 2020. The term of the new lease expires on August 31, 2019.February 28, 2021.

 

Rent expenseexpenses for these offices for the three months ended JanuaryJuly 31, 20182020 and 2017 was $8,3272019 were $7,152 and $13,702, respectively, and $25,152 and $37,131 for the nine months ended January 31, 2018 and 2017,$8,661, respectively.

 

The following table summarizes the Company’s aggregate future minimum lease payments required under the officeoperating lease for the Leased Premises as of JanuaryJuly 31, 2018.2020.

 

Periods Ending January 31,  Amount 
 2018  $33,084 
 2019   19,299 
    $52,383 
  Amount 
2021 $12,456 
  $12,456 

 

LicenseMaterial Agreements

 

Binding Term SheetThe Company’s material agreements are identified and summarized in Note 1 – Nature of Business – Company Background.

 

On August 30, 2017, the Company entered into a binding Term Sheet (“Term Sheet”) with SG Austria and Austrianova pursuant to which the parties reached an agreement to amend certain provisions in the APA, the Diabetes Licensing Agreement and the Cannabis Licensing Agreement.

The Term Sheet provides that the Company’s obligation to make milestone payments to Austrianova will be eliminated in their entirety under (i) the Cannabis License Agreement, (ii) the Diabetes License Agreement and (iii) the APA. The Term Sheet also provides that the scope of the Diabetes License Agreement will be expanded to include all cell types and cell lines of any kind or description now or later identified, including, but not limited to, primary cells, mortal cells, immortal cells and stem cells at all stages of differentiation and from any source specifically designed to produce insulin for the treatment of diabetes.

 

 

 

 2023 

 

In addition, the Term Sheet provides that the Company will have a 5-year right of first refusal in the event that Austrianova chooses to sell, transfer or assign at any time during such period the Cell-in-a-Box® tradename and its associated technology, intellectual property, trade secrets and know-how, which includes the right to purchase any manufacturing facility used for the Cell-in-a-Box® encapsulation process and a non-exclusive license to use the special cellulose sulphate utilized with the Cell-in-a-Box® encapsulation process (collectively, “Associated Technologies”); provided, however, that the Associated Technologies subject to the right of first refusal do not include Bac-in-a-Box®. Additionally, for a period of one year following the date of the Term Sheet, the Term Sheet provides that Austrianova will not solicit, negotiate or entertain any inquiry regarding the potential acquisition of the Cell-in-a-Box® and its Associated Technologies.

The Term Sheet further provides that (i) the royalty payments on gross sales as specified in the Cannabis License Agreement, the Diabetes License Agreement and the APA will be changed to 4% and (ii) the royalty payments on amounts received by the Company from sublicensees on sublicensees’ gross sales under the same agreements will be changed to 20% of the amount received by the Company from its sublicensees,provided, however, that in the event the amounts received by the Company from sublicensees is 4% or less of sublicensees’ gross sales, Austrianova will receive 50% of what the Company receives (up to 2%) and then additionally 20% of any amount the Company receives over 4%.

The Term Sheet provides that Austrianova will receive 50% of any other financial and non-financial consideration received from the Company’s sublicensees of the Cell-in-a-Box® technology. The Term Sheet also provides that the Company will pay Austrianova Singapore $150,000 per month for a period of six months upon the execution of the amendments to the Term Sheet.

Finally, the Term Sheet provides that Prof. Walter H. Günzburg, who currently serves as the Chief Scientific Officer of the Company, will not receive any cash compensation from the Company for services rendered as the Company’s Chief Scientific Officer for a period of six months beginning September 1, 2017.

As of January 31, 2018, the amendments to the APA, the Diabetes Licensing Agreement and the Cannabis Licensing Agreement to be entered into pursuant to the Term Sheet have not been finalized. The terms have been generally agreed to and the Company has made payments totaling $600,000. As of January 31, 2018, the Company’s obligation under the Term Sheet is $300,000. (See Note 4).

Melligen Cell License Agreement

The Melligen Cell License Agreement requires that the Company pay royalty, milestone payments and patent costs to UTS as follows:

·6% gross exploitation revenue on product sales by the Company;
·25% of gross revenues if the product is sub-licensed by the Company;
·Milestone payments of AU$ 50,000 at the successful conclusion of clinical studies, AU$ 100,000 at the successful conclusion of Phase 1 clinical trial, AU$ 450,000 at the successful conclusion of Phase 2 clinical trials and AU$ 3,000,000 upon conclusion of a Phase 3 clinical trial; and
·Patent prosecution costs for the Melligen Cells plus a 15% patent administration fee to UTS related to the licensed intellectual property.

Agreement with Eurofins

On June 5, 2017, and as amended on January 24, 2018, the Company and Eurofins Lancaster Laboratories, Inc. (“Eurofins”) entered into an agreement for the preparation and characterization of a Master Cell Bank (“MCB”) for use in the Company’s therapy for pancreatic cancer. The agreement includes pre-bank testing, MCB preparation and MCB characterization, as well as optional testing. The total future costs to the Company, without optional testing, is estimated to be approximately $150,000.

 

Compensation Agreements

 

The Company entered into executive compensation agreements with its three executive officers in March 2015, each of which was amended in December 2015.2015 and March 2017. Each agreement has a term of two years.years with automatic annual extensions thereafter unless the Company or the officer provides written notification of termination at least ninety days prior to the end of the term or subsequent extensions. The Company also entered a compensation agreement with a Board member in April 2015 which continuescontinued in effect until amended in May 2017.

In May 2017, the Company amended the compensation agreement with the Board members and the terms continue in effect until a member is no longer on the Board.

 

In March 2017, theThe Company amended the executive compensation agreements. The term for each agreement is two years from an effective date of January 1, 2017. Athas four independent directors. Each director receives the same time, the Company amended the compensation agreement with the Board member referenced above. It continues in effect until the member is no longer on the Board.

21

In May 2017, the Company appointed Mr. Thomas C.K. Yuen to the Board to fill a vacancy created by the departure of certain members of the Board in October 2014. In connection with Mr. Yuen’s appointment to the Board, the Company entered into a Board compensation agreement with Mr. Yuen pursuant to which the Company agreed to pay Mr. Yuencompensation: (i) $12,500 in cash for each calendar quarter of service on the Board and agreed to issue annually: (i)Board; (ii) 500,000 fully-paid, non-assessable shares of the Company’s restricted common stock (“Yuen Shares”); annually; and (ii)(iii) a five-year option to purchase 500,000 Yuen Shares (“Yuen Option”) to Mr. Yuenannually at an exercise price equal to the fair market value of the Company’s common stockShares on the date of grant. The Yuen Shares and the Yuen Option wereoption Shares fully vestedvest on the date of the grants. The Board approved the initial issuances of the Yuen Shares and the Yuen Option on May 1, 2017, and the Yuen Option has an exercise price of $0.058 per share of common stock.

  

In July 2017, the Board appointed Dr. Michael M. Abecassis to the Board to fill a vacancy created by the departure of certain members of the Board in October 2014. In connection with the appointment of Dr. Abecassis to the Board, the Company entered into a Board compensation agreement with Dr. Abecassis pursuant to which the Company agreed to pay Dr. Abecassis $12,500 in cash for each calendar quarter of service on the Board and agreed to issue him annually: (i) 500,000 fully-paid, non-assessable shares of the Company’s restricted common stock (“Abecassis Shares”); and (ii) a five-year Option to purchase 500,000 Abecassis Shares (“Abecassis Option”) at an exercise price equal to the fair market value of the common stock on the date of the grant. The Abecassis Shares and the Abecassis Option were fully vested on the date of the grants. The Board approved the initial issuances of the Abecassis Shares and the Abecassis Option on July 3, 2017, and the Abecassis Option has an exercise price of $0.058 per share of common stock.

In July 2017, the Board appointed Dr. Linda S. Sher to the position of the Company’s Chief Medical Officer (“CMO”). In connection with the appointment, the Company entered into a Professional Services Agreement (“PSA”) with Dr. Sher pursuant to which the Company agreed to pay Dr. Sher $10,000 in cash for each calendar month of service as the Company’s CMO. The Company also agreed to issue Dr. Sher: (i) 1,200,000 fully-paid, non-assessable shares of the Company’s restricted common stock (“Sher Shares”); and (ii) a five-year Option to purchase 1,200,000 Sher Shares (“Sher Option”) at an exercise price equal to the fair market value of the Company’s shares of commons stock on the date of the grant. The Sher Shares and the Sher Option each vest in the amount of 100,000 shares per month. The Board approved the issuances of the Sher Shares and the Sher Option on July 18, 2017, and the Sher Option has an exercise price of $0.089 per share of common stock. Effective as of the effective date of the PSA, the agreement was amended to provide that the Company will indemnify Dr. Sher for her work as the Company’s CMO.

In October 2017, the Board appointed Dr. Raymond C.F. Tong to the Board to fill a vacancy created by the departure of certain members of the Board in October 2014. In connection with Dr. Tong’s appointment to the Board, the Company entered into a Board compensation agreement with Dr. Tong pursuant to which the Company agreed to pay Dr. Tong $12,500 in cash for each calendar quarter of service on the Board and agreed to issue annually: (i) 500,000 fully-paid, non-assessable shares of restricted common stock (“Tong Shares”); and (ii) a five-year option to purchase 500,000 Tong Shares (“Tong Option”) to Dr. Tong at an exercise price equal to the fair market value of the Company’s common stock on the date of grant. The Tong Shares and the Tong Option were fully vested on the date of the grants. The Board approved the initial issuances of the Tong Shares and the Tong Option on October 9, 2017, and the Tong Option has an exercise price of $0.055 per share of common stock.

NOTE 1110 - INCOME TAXES

 

The Company had no income tax expense for the three and nine months ended JanuaryJuly 31, 20182020 and 2017,2019, respectively. During the ninethree months ended JanuaryJuly 31, 20182020 and 2017,2019, the Company had a net operating loss (“NOL”) for each period which generated deferred tax assets for NOL carryforwards. The Company provided valuation allowances against the net deferred tax assets including the deferred tax assets for NOL carryforwards. Valuation allowances provided for the net deferred tax asset increased by approximately $1,341,000$98,000 and $830,000$201,000 for the ninethree months ended JanuaryJuly 31, 20182020 and 2017,2019, respectively.

 

There was no material difference between the effective tax rate and the projected blended statutory tax rate for the ninethree months ended JanuaryJuly 31, 20182020 and 2017.2019.

 

In assessingCurrent tax laws limit the realizationamount of deferred tax assets, management considered whether itloss available to be offset against future taxable income when a substantial change in ownership occurs. Therefore, the amount available to offset future taxable income may be limited. Based on the assessment of all available evidence including, but not limited to, the Company’s limited operating history in its core business and lack of profitability, uncertainties of the commercial viability of its technology, the impact of government regulations and healthcare reform initiatives and other risks normally associated with biotechnology companies, the Company has concluded that is more likely than not that some portion or all of the deferred assetthese operating loss carryforwards will not be realized. The ultimate realizationAccordingly, 100% of the deferred tax assets is dependent upon the generation of future taxable income during the periods in which those temporary differences become deductible. Based on the available objective evidence, including the history of operating losses and the uncertainty of generating future taxable income, management believes it is more likely than not that the net deferred taxvaluation allowance has been recorded against these assets at JanuaryJuly 31, 2018 will not be fully realizable. Accordingly, management has maintained a valuation allowance against the net deferred tax assets at January 31, 2018.

On December 22, 2017, the U.S. government enacted comprehensive tax legislation commonly referred to as the Tax Cuts and Jobs Act (the “Tax Act”). The Tax Act makes broad and complex changes to the U.S. tax code including lowering the U.S. federal tax rate to 21%.

22

The SEC staff issued Staff Accounting Bulletin No. 118 (“SAB 118”), which provides guidance for the accounting of the effects of the Tax Act. SAB 118 provides a measurement period that should not be extended past a year from the enactment date for companies to complete the accounting of the Tax Act under ASC Topic 740,Income Taxes(“ASC 740”). Companies that do not complete the accounting under ASC 740 for the tax effects of the Tax Act, must record a provisional estimate of the tax effects of the Tax Act. If a provisional estimate cannot be determined a company should continue to apply ASC 740 based on the tax laws in effect immediately before the enactment of the Tax Act.

At January 31, 2018, the Company has not completed the accounting for the tax effects of the Tax Act; however, the Company has made a reasonable estimate of the effects on the rate change on its existing deferred tax assets by decreasing its deferred tax assets by approximately $5,447,000. The Company has a full valuation allowance; therefore, the decrease in deferred tax assets did not impact the tax expense in the accompanying condensed consolidated statements of operations.

In order to complete the accounting requirements under ASC 740, the Company needs to (a) evaluate the impact of additional guidance, if any, from the FASB and external providers on its application of ASC 740 to the calculation; (b) evaluate the impact of further guidance from Treasury and/or the Internal Revenue Service on the technical application of the law with regard to our facts; (c) evaluate the impact of further guidance from the state tax authorities regarding their conformity to the provisions of the Tax Act; and (d) complete the analysis of the revaluation of deferred tax assets and liabilities as the Company is still analyzing certain aspects of the Tax Act. The accounting for the tax effects for the Tax Act will be completed in 2018.2020.

 

The Company’s policy is to recognize any interest and penalties related to unrecognized tax benefits as a component of income tax expense. As of the ninethree months ended JanuaryJuly 31, 20182020 and 2017,2019, the Company had no accrued no interest or penalties related to uncertain tax positions.

 

See Note 1210 of Notes to the Consolidated Financial Statements included in the Company’s Annual Report on Form 10-K for the year ended April 30, 20172020 for additional information regarding income taxes.

24

 

NOTE 1211 – EARNINGS PER SHARE

 

Basic earnings (loss) per share is computed by dividing earnings (loss) available to common stockholders by the weighted average number of shares outstanding during the period. Diluted earnings (loss) per share is computed by dividing net income (loss) by the weighted average number of shares and potentially dilutive shares of common sharesstock outstanding during the period increased to include the number of additional shares of common stock that would be outstanding if the potentially dilutive securities had been issued. Potential shares of common sharesstock outstanding principally include stock options and warrants. During the ninethree months ended JanuaryJuly 31, 20182020 and 2017,2019, the Company incurred losses. Accordingly, the effect of any common stock equivalent would be anti-dilutive during those periods and are not included in the calculation of diluted weighted average number of shares outstanding.

 

The table below sets forth the basic loss per share calculations:

 

  Nine Months Ended January 31, 
  2018  2017 
Net loss $(5,533,373) $(3,288,663)
Basic weighted average number of shares outstanding  958,198,483   832,203,911 
Diluted weighted average number of shares outstanding  958,198,483   832,203,911 
Basic and diluted loss per share $(0.01) $(0.00)

23

  Three Months Ended July 31, 
  2020  2019 
Net loss $(883,944) $(1,134,075)
Basic weighted average number of shares outstanding  1,678,572,167   1,210,305,834 
Diluted weighted average number of shares outstanding  1,678,572,167   1,210,305,834 
Basic and diluted loss per share $(0.00) $(0.00)

 

The table below sets forth these potentially dilutive securities:

 

 Nine Months Ended January 31,  Three Months Ended July 31, 
 2018 2017  2020  2019 
Excluded options  95,250,000   81,150,000   68,700,000   108,950,000 
Excluded warrants  48,850,197   66,983,939   59,323,488   45,411,130 
Total excluded options and warrants  144,100,197   148,133,939   128,023,488   154,361,130 

 

  Three Months Ended January 31, 
  2018  2017 
Net loss $(2,030,660) $(1,282,146)
Basic weighted average number of shares outstanding  975,848,246   859,529,933 
Diluted weighted average number of shares outstanding  975,848,246   859,529,933 
Basic and diluted loss per share $(0.00) $(0.00)

NOTE 12 – PREFERRED STOCK

 The Company has authorized 10,000,000 shares of preferred stock, with a par value of $0.0001, of which one share has been designated as "Series A Preferred Stock". The one share of Series A Preferred Stock was issued on October 30, 2019 and repurchased by the Company on December 3, 2019. As of July 31, 2020, there are no shares of preferred stock issued and outstanding.

 

The tabledescription of the Series A Preferred Stock below sets forth these potentially dilutive securities:is qualified in its entirety by reference to the Company’s Articles of Incorporation, as amended.

 

  Three Months Ended January 31, 
  2018  2017 
Excluded options  95,250,000   81,150,000 
Excluded warrants  48,850,197   66,698,939 
Total excluded options and warrants  144,100,197   148,133,939 

The Series A Preferred Stock has the following features:

There is one share of preferred stock designated as Series A Preferred Stock;
The Series A Preferred Stock has a number of votes at any time equal to the number of votes then held by all other shareholders of the Company having a right to vote on any matter plus one. The Certificate of Designations that designated the terms of the Series A Preferred Stock cannot be amended without the consent of the holder of the Series A Preferred Stock;

25

The Company may redeem the Series A Preferred Stock at any time for a redemption price of $1.00 paid to the holder of the share of Series A Preferred Stock; and
The Series A Preferred Stock has no rights of transfer, conversion, dividends, preferences upon liquidation or participation in any distributions to shareholders.

  

NOTE 13 – SUBSEQUENT EVENTS

 

On February 22, 2018, the Company entered into a financial advisory, offering and at the market offering letter agreement (“Agreement”) with Aeon Capital, Inc. (“Aeon”) pursuant to which the Company may sell from time to time, at its option, shares of its common stock, $0.0001 par value per share (“Shares”), having an aggregate offering price of up to $25,000,000,From August 1, 2020 through Aeon as the Company’s financial advisor and exclusive placement agent. Sales of the Shares will be made under the Company’s previously filed and currently effective Registration Statement on Form S-3 (File No. 333-220441) in transactions that are deemed to be “at the market offerings” as defined in Rule 415 under the Securities Act of 1933, as amended, or transactions structured as a public offering of a distinct block or blocks of the Shares (“Block Trade”).

From February 1, 2018 to March 16, 2018,August 12, 2020, the Company sold 33,333,333 Sharesapproximately 459 million shares of common stock using the S-3 structured as a Block Trade.Trade transactions. The issuance of the Sharesthese shares resulted in gross proceeds to the Company of $1.0approximately $3 million. Pursuant to the Aeon Engagement Agreement, the Company paid Aeon a fee of 7% ($70,000)approximately $183,000 and provided warrant coverage of 5% of the number of shares of commons stock sold in the Block Trade transactions This amounted to approximately 34 million warrant shares with a five-year termterm. The warrants have a cashless exercise feature. In addition, the Company incurred transaction fees of approximately 1.67 million warrant shares.$96,000 to an unrelated party.

On September 1, 2020, the Company submitted the IND to the FDA to allow the Company to commence a Phase 2b human clinical trial involving LAPC. Although no assurance as to the timing of the trial can be given or whether the FDA will allow the Company to commence a Phase 2b clinical trial as opposed to a Phase 1 clinical trial or further preclinical studies. The IND consisted of all available preclinical information (e.g. animal toxicity studies), Chemistry, Manufacturing and Controls information and other pre-clinical information about the Company’s product candidate to treat LAPC, as well as information regarding the proposed clinical trial program and other information and documentation required by FDA regulations. On September 4, 2020, the Company received an Information Request from the FDA. The Company responded to the FDA’s Information Request on September 11, 2020.

 

 

 

 

 2426 

 

 

Item 2.  Management’s Discussion and Analysis of Financial Conditions and Results of Operations.Operations

 

Cautionary Note Regarding Forward-Looking Statements

 

This Quarterly Report on Form 10-Q (“Report”) includes “forward-looking statements” within the meaning of the federal securities laws. All statements other than statements of historical fact are “forward-looking statements” for purposes of this Report, including any projections of earnings, revenue or other financial items, any statements regarding the plans and objectives of management for future operations, any statements concerning proposed new products or services, any statements regarding future economic conditions or performance, any statements regarding expected benefits from any transactions and any statements of assumptions underlying any of the foregoing. In some cases, forward-looking statements can be identified by use of terminology such as “may,” “will,” “should,” “believes,” “intends,” “expects,” “plans,” “anticipates,” “estimates,” “goal,” “aim,” “potential” or “continue,” or the negative thereof or other comparable terminology.terminology regarding beliefs, plans, expectations or intentions regarding the future, including risks relating to the recent outbreak of COVID-19. Although we believe that the expectations reflected in the forward-looking statements contained in this Report are reasonable, there can be no assurance that such expectations or any of the forward-looking statements will prove to be correct, and actual results could differ materially from those projected or assumed in the forward-looking statements. Thus, investors should refer to and carefully review information in future documents we file with the Commission. Our future financial condition and results of operations, as well as any forward-looking statements, are subject to inherent risk and uncertainties, including, but not limited to, the risk factors set forth in “Part I, Item 1A – Risk Factors” set forth in our Form 10-K for the yearperiod ended April 30, 20172020 and for the other reasons described elsewhere in this Report

Report. Among others, these include our estimates regarding expenses, future revenues, capital requirements and needs for additional financing; whether the FDA approves our recently submitted IND after it has been reviewed by the FDA so that we can commence our planned clinical trial involving LAPC; the success and timing of our preclinical studies and clinical trials; the potential that results of preclinical studies and clinical trials may indicate that any of our technologies and product candidates are unsafe or ineffective; our dependence on third parties in the conduct of our preclinical studies and clinical trials; the difficulties and expenses associated with obtaining and maintaining regulatory approval of our product candidates; the material adverse impact that the coronavirus pandemic may have on our business, including our planned clinical trial involving LAPC, which could materially affect our operations as well as the business or operations of third parties with whom we conduct business; and whether the FDA will approve our product candidates after our clinical trials are completed, assuming the FDA allows our clinical trials to proceed after review of our IND submission for LAPC. All forward- looking statements and reasons why results may differ included in this Report are made as of the date hereof, and we do not intend to update any forward-looking statements except as required by law or applicable regulations. Except where the context otherwise requires, in this Report, the “Company,” “we,” “us” and “our” refer to PharmaCyte Biotech, Inc., a Nevada corporation, and, where appropriate, its subsidiaries.

 

OverviewProduct Candidates

 

We are a clinical stage biotechnology company focused on developing and preparing to commercialize cellular therapies for cancer and diabetes based upon a proprietary cellulose-based live cell encapsulation technology known as “Cell-in-a-Box®.” The Cell-in-a-Box® Cell-in-a-Box® technology is intended to be used as a platform upon which therapies for several types of cancer, including locally advanced, non-metastatic inoperable pancreatic cancer,LAPC and Type 1 and insulin dependent Type 2 diabetes will be developed.

 

We are developing therapies for pancreatic and other solid cancerous tumors by using genetically engineered live human cells that we believe are capable of converting a cancer prodrug into its cancer-killing form, encapsulating those cells using the encapsulation of live cells which are surgically implanted at appropriate sitesCell-in-a-Box® technology and placing those capsules in the body as close as possible to enable the deliverytumor. In this way, we believe that when the cancer prodrug is administered to a patient with a particular type of a cancer-killing chemotherapy drug atcancer that may be affected by the sourceprodrug, the killing of the cancer. We are working onpatient’s tumor may be optimized.

On September 1, 2020, we submitted our IND to submit to the United States Food and Drug Administration (“FDA”) so that we can commence a clinical trial involving locally advanced, inoperable non-metastatic pancreatic cancer. Based on advice from our consulting oncologists, our Chief Medical Officer and our Advisory Board regarding our planned trial design, we have determined that the data contained in previous clinical trial reports are not enough to fully support a Phase 3 pivotal trial. Therefore, we are designingFDA for a Phase 2b clinical trial in LAPC. However, no assurance as to the timing of the trial can be given or whether the FDA will allow us to commence a Phase 2b clinical trial as opposed to a Phase 1 clinical trial or further preclinical studies. The IND consisted of all available preclinical information (e.g. animal toxicity studies), Chemistry, Manufacturing and Controls information and other pre-clinical information about our product candidate to treat LAPC, as well as information regarding our proposed clinical trial program and other information and documentation required by FDA regulations. On September 4, 2020, we received an Information Request from the FDA. We responded to the FDA’s Information Request on September 11, 2020.

We must wait a minimum of 30 calendar days from the date of the IND submission before initiating our clinical trial. During this time, the FDA has an opportunity to review the IND to ensure that if successful, we believeit is complete and that the planned clinical trial research patients will providenot be subject to unreasonable risk. It also gives the FDA time to ask for more information and clarification about the information necessarysubmitted as was done with the FDA’s September 4, 2020 Information Request. If the FDA is not satisfied with the our September 11, 2020 response to the Information Request or our responses to any future Information Requests or the FDA identifies other issues with the our IND, the FDA can place a clinical hold on the clinical trial described in the IND. If the FDA does so, we cannot initiate the clinical trial to treat LAPC until or unless the FDA lifts the clinical hold. It is possible that the FDA may not permit us to initiate the clinical trial based on the available data and information.

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We are also examining ways to exploit the benefits of the Cell-in-a-Box® technology to develop therapies for cancer that involve prodrugs based upon certain constituents of the Cannabis plant; these constituents are of the class of compounds known as “cannabinoids”. Until the FDA allows us to commence the clinical trial involving LAPC described in our recently submitted IND, we will not spend any further resources developing this program.

In addition, we are developing a successful Phase 3 pivotaltherapy to delay the production and accumulation of malignant ascites fluid that results from many types of abdominal cancerous tumors. Malignant ascites fluid is secreted by abdominal cancerous tumors into the abdomen after the tumors have reached a certain stage of growth. This fluid contains cancer cells that can seed and form new tumors throughout the abdomen. This fluid accumulates in the abdominal cavity, causing swelling of the abdomen, severe breathing difficulties and extreme pain. We are using our therapy for pancreatic cancer to determine if it can prevent or delay the production and accumulation of malignant ascites fluid. As with our Cannabis program, until the FDA allows us to commence the clinical trial and possible accelerated approval by the FDA.involving LAPC described in our recently submitted IND, we will not spend any further resources developing this program.

 

We are also developing a therapy for Type 1 diabetes and insulin-dependent Type 2 diabetes. The Company’sOur diabetes therapy consists of encapsulatingencapsulated genetically modified human liver cells and/or beta islet cellsand insulin-producing stem cells. The encapsulation for each type of cell will be done using the Cell-in-a-Box® technology and then implanting themtechnology. Implanting these cells in the body is designed to actfunction as a bio-artificial pancreas for purposes of insulin production. As with the two previous programs, we are not spending any further resources developing this program until the FDA allows us to commence the clinical trial involving LAPC described in our recently submitted IND. However, work at UTS on the Melligen cells continues. Melligen cells are human liver cells that have been genetically engineered to produce, store and release insulin in response to the levels of blood sugar in the body.

 

Finally, we have licensed from Hai Kang the right to certain technology owned or controlled by Hai Kang related to COVID-19 diagnostic kits (“Kits”). Our license is both for the sale of Kits as well as for the use of the technology underlying the Kits. Pursuant to the Hai Kang License Agreement, we may directly (or through a third party) conduct research, use, develop, market, sell, distribute, import and export Kits and utilize their underlying technology for human and veterinary uses in North America, the United Kingdom and certain other European sites collectively, (“Territory”). A “Product” is defined as any existing Kit of Hai Kang or any future Kit derived from Hai Kang’s Kits and includes an in vitro diagnostic test.

We are required to use its commercially reasonable efforts to develop and commercialize at least one Product in the Territory. This obligation to develop and commercialize a Product includes, among other things, the performance of non-clinical and clinical studies of any Product, the preparation, filing and prosecution of certain regulatory requests for authorization or approval for such Product (including to allow the Company to market and sell the Product and to get the Product approved for reimbursement). Hai Kang is responsible for all aspects of the manufacture and supply of the Products to be developed and sold under the Hai Kang License Agreement.

During the term of the Hai Kang License Agreement, we are required to pay a monthly fee to Hai Kang in the amount of $6,000, which monthly fee increases to $50,000 once the first Product receives regulatory authorization or approval from the FDA. In addition, we are examining ways to exploit the benefits of the Cell-in-a-Box® technology to develop therapies for cancer based upon the constituentsfirst commercial sale of a Product, the Cannabis plant, known as “Cannabinoids.”Company is required to make quarterly royalty payments equal to 10% of Net Sales (as defined in the Hai Kang License Agreement) of any Product sold pursuant to the Hai Kang License Agreement.

With respect to the Hai Kang License Agreement and related products, including the Kits, we may not be able to (i) develop a related product candidate with our current resources, on a timely basis, or at all; (ii) obtain the necessary regulatory authorizations or approvals for such a product candidate or for a Kit; (iii) commercialize any such product candidate or Kit; or (iv) obtain reimbursement for such a product candidate or Kit in the U.S. and elsewhere. It is uncertain that any such product candidates or Kit will comply with U.S. regulatory requirements or that any health care facility or provider will be willing or able to use such product candidates or Kits.

 

 

 

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COVID-19 Potential Impact on the Financial Condition and Results of Operations

The development of our product candidates could be disrupted and materially adversely affected in the future by a pandemic like the recent outbreak of COVID-19. For example, as a result of measures imposed by the governments in states affected by COVID-19, businesses and schools have been suspended due to quarantines or stay at home orders intended to contain the pandemic. COVID-19 continues to spread globally and, as of July 31, 2020, has spread to over 150 countries, including the U.S. While the COVID-19 pandemic is thought to be in its early stages, international stock markets continue to reflect the uncertainty associated with the slow-down in the world economies and the reduced levels of international travel experienced since the beginning of January 2020. As of the date of this Report, the COVID-19 pandemic has had an impact upon our operations, although we believe that impact is not material.

We are still assessing our business plans and the impact COVID-19 may have on our ability to advance the development of our product candidates or to raise financing to support the development of our product candidates, but no assurances can be given that this assessment will enable us to avoid part or all of any impact from the spread of COVID-19 or its consequences, including downturns in the business sector generally or in our sector in particular. The spread of COVID-19 may also result in the inability of our suppliers to deliver components or raw materials on a timely basis or materially and adversely affect our collaborators’ and potential strategic partners’ ability to conduct our planned clinical trial in LAPC and our other operations. The recent and ongoing COVID-19 pandemic could materially affect our operations, as well as the business or operations of third parties with whom we conduct business. Our business could be adversely affected by the effects of other future health pandemics in regions where we or third parties on which we rely have significant business operations. See the risk factors set forth in “Part I, Item 1A – Risk Factors” set forth in our Form 10-K for period ended April 30, 2020 and for the reasons described elsewhere in this Report.

 

Performance Indicators

 

Non-financial performance indicators used by management to manage and assess how the business is progressing will include, but are not limited to, the ability to: (i) acquire appropriate funding for all aspects of our operations; (ii) acquire and complete necessary contracts; (iii) complete activities for producing genetically modified human cells and having them encapsulated for the plannedour preclinical studies and the planned clinical trials;trial in LAPC; (iv) have regulatory work completed to enable studies and trials to be submitted to regulatory agencies; (v) initiatecomplete all purityrequired tests and toxicology cellular assessments;studies on the cells and (vi) ensure the manufacture of encapsulated cells in accordance with current good manufacturing procedures (“cGMP”)capsules we plan to use in our clinical trials.trial in patients with LAPC; and (vi) ensure completion of the production of encapsulated cells according to cGMP regulations to use in our planned clinical trial involving LAPC.

 

There are numerous factorsitems required to be completed successfully to ensure our final product candidates arecandidate is ready for use in our planned clinical trials. Therefore, thetrial involving LAPC. The effects of material transactions with related parties, and certain other parties to the extent necessary for such an undertaking, may have substantial effects on both the timeliness and success of our current and prospective financial position and operating results. Nonetheless, we are actively working to ensure strong ties and interactions to minimize the inherent risks regarding success. From our assessments to date, weWe do not believe there are factors which will cause materially different amounts to be reported than those presented in this Report andReport. We aim to assess this regularly to provide the most accurate information to our shareholders.

 

Results of Operations

 

Three and nine months ended JanuaryJuly 31, 20182020 compared to three and nine months ended JanuaryJuly 31, 20172019

 

Revenue

 

We had no revenues infor the three and nine months ended JanuaryJuly 31, 20182020 and 2017.2019.

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Operating Expenses and Loss from Operations

 

The following table summarizesummarizes our operating expenses and loss from operations for the three and nine months ended JanuaryJuly 31, 20182020 and 2017,2019, respectively:

  

Three Months Ended January 31,  Nine Months Ended January 31, 
2018  2017  2018  2017 
$2,030,660  $1,282,015  $5,533,373  $3,287,607 
Three Months Ended July 31, 
2020  2019 
$881,676  $1,134,075 

 

The total operating expenses for the three-month period ended JanuaryJuly 31, 2018 increased2020 decreased by $748,645$252,399 from the three months ended JanuaryJuly 31, 2017.2019. The increasedecrease is attributable to an increasea decrease in researchgeneral and development costadministrative (“G&A”) expenses of $222,847, an increase$304,400, a decrease in director fees of $22,093, an increase$3,618, a decrease in compensation expense of $239,445, a decrease$174,224 net of an increase in legal and professional expense of $36,762$31,599 and an increase in general and administrativeR&D expense of $198,244. The decrease in G&A expenses of $301,022. The increase in general and administrative expenses waswere mainly attributable to an increasereductions in consulting fees and travel expenses.

 

The total operating expenses for the nine-month period ended January 31, 2018 increased by $2,245,766 from the nine months ended January 31, 2017. The increase is attributable to an increase in research and development cost of $737,203, an increase in director fees of $182,574, an increase in compensationOther expense of $489,914, an increase in legal and professional expanse of $56,011 and an increase in general and administrative expenses of $780,064. The increase in general and administrative expenses was mainly attributable to an increase in consulting and travel expenses.

Director fees for the three months ended January 31, 2018 increased by $22,093 from the three months ended January 31, 2017. The increase is attributable to an increase in the number of independent directors. Pursuant to the agreements we have entered into with our independent directors we pay a director compensation fee of $12,500 per quarter. Board compensation for non-independent directors is included in the amounts they receive under their respective executive compensation agreement.

26

Director fees for the nine months ended January 31, 2018 increased by $182,574 from the nine months ended January 31, 2017. The increase is attributable to an increase in the number of independent directors. Pursuant to the agreements we have entered into with our independent directors we pay a director compensation fee of $12,500 per quarter. The independent directors were awarded stock grants and stock options during the nine months ended January 31, 2018 in the amount of $64,827. Board compensation for non-independent directors is included in the amounts they receive under their respective executive compensation agreement.

Other income (expense), net

 

The following table sets forth our other income (expense), net for the three and nine months ended January 31, 2018 and 2017:

Three Months Ended January 31,  Nine Months Ended January 31, 
2018  2017  2018  2017 
$  $(131) $  $(1,056)

Total other income (expense), net,expense for the three months ended JanuaryJuly 31, 2018 decreased2020 and 2019:

Three Months Ended July 31, 
2020  2019 
$2,268  $ 
       

Total other expense for the three months ended July 31, 2020 increased by the amount of $131$2,268 from the three months ended JanuaryJuly 31, 2017.2019. The decreaseincrease is attributable to the reductionincrease of interest expense in the amount of $131.

Total other$388, an increase in income (expense), net, for the nine months ended January 31, 2018 decreased by the amounttaxes of $1,056 from the nine months ended January 31, 2017. The decrease is attributable to the reduction$800 and an increase in foreign exchange losses of interest expense in the amount of $1,056.$1,080.

 

Discussion of Operating, Investing and Financing Activities

 

The following table presents a summary of our sources and uses of cash for the ninethree months ended JanuaryJuly 31, 20182020 and 2017,2019, respectively:

 

 Nine Months Ended  Three Months Ended 
 January 31, 2018 January 31, 2017  July 31, 2020  July 31, 2019 
Net cash used in operating activities: $(3,704,812) $(2,538,575) $(551,002) $(763,140)
Net cash used in investing activities: $  $       
Net cash provided by financing activities: $1,751,409  $3,080,883   1,820,060   582,500 
Effect of currency rate exchange $(2,979) $1,138   2,677   (6,862)
Net increase (decrease) in cash $(1,956,382) $543,446  $1,271,735  $(187,502)

 

Operating Activities:

 

The net cash used in operating activities for the ninethree months ended JanuaryJuly 31, 20182020 is a result of our net losses, increases in accounts payable, a decrease in prepaid expenses and an increase in securities issued for services and compensation, net of a decrease in accrued expenses. The cash used in operating activities for the three months ended July 31, 2019 is a result of our net losses, offset by securitiesan increase in stock issued, for services and compensation, a decreasean increase to prepaid expenses and decreases to accounts payable offset by an increase in accrued expenses and an increase in term sheet agreement liability. The cash used in operating activities for the nine months ended January 31, 2017 is a result of our net losses: (i) offset by an increase in stock issued, decreases to prepaid expenses, accounts payable and accrued expenses; and (ii) decreased by the reduction in license agreement liability.expenses. See Condensed Consolidated Statements of Cash Flows on page 7.

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Investing Activities:

 

There were no investing activities in the ninethree months ended JanuaryJuly 31, 20182020 and 2017.2019.

 

Financing Activities:

 

The cash provided from financing activities is mainly attributable to the proceeds from the sale of our common stock.stock net of the use of funds for payment of insurance financing.

 

Liquidity and Capital Resources

 

As of JanuaryJuly 31, 2018,2020, our cash totaled approximately $1.5 million,$2,167,000, compared to approximately $3.5 million$328,000 at April 30, 2017.July 31, 2019. Working capital was approximately $709,000$1,116,000 at JanuaryJuly 31, 20182020 and approximately $3.0 milliona negative $130,000 at April 30, 2017.July 31, 2019. The decreaseincrease in cash is attributable to a higher beginning cash balance, an increase in proceeds from the sale of our common stock net of the increaseoffset by a decrease in our operating expenses. As of August 31, 2020, our cash totaled approximately $4,537,000.

 

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We believe thatDuring the three months ended July 31, 2020, funding was provided by investors to maintain and expand our cash on hand as of January 31, 2018, the sales of registeredoperations and unregistered sharesR&D. Sales of our common stock and any public offeringswere consummated using the S-3. During the three months ended July 31, 2019, we continued to acquire funds through our S-3 pursuant to Block Trades transactions in a program which is structured to provide up to $25 million dollars to us less certain commissions pursuant to the S-3.

As of common stockAugust 13, 2020, we no longer met the eligibility requirements to use the S-3.

In Note 2 – Going Concern to our Condensed Consolidated Financial Statements set forth in whichthis Report, we may engage will provide sufficient capitalnote that certain conditions raise substantial doubt about our ability to meet our capital requirements and to fund our operations through March 31, 2019. We plan to pursue additional funding opportunities in connection with planning for and conducting our Phase 2b clinical trial in LAPC. Among others, we intend on continuing the sale of our common stock to raise capital to fund these activities and for working capital for corporate purposes, if necessary.continue as a going concern.

 

Off-Balance Sheet Arrangements

 

Except as described below, we have no off-balance sheet arrangements that could have a material current effect or that are reasonably likely to have a material futureadverse effect on our financial condition, changes in financial condition, revenues or expenses, results of operations, liquidity, capital expenditures or capital resources.

 

The future royalty payments underOn May 14, 2018, we entered into the APA,Amendments to all of the Diabetes License Agreementmaterial agreements with SG. Austria and the Cannabis License Agreement (to be amendedAustrianova. See “Company Background and Material Agreements” above for a description of these Amendments.

Service Agreements

We entered into several service agreements, with both independent and related parties, pursuant to which services will be provided over the Term Sheet) are: (i) 4% royalty on all gross sales by us;next twenty-four months related to our IND and (ii) 20% royalty on gross revenues we receive from sublicensing,provided, however,that in the event the amounts received by us from sublicensees is 4% or less of sublicensees’ gross sales, Austrianova will receive 50% of what we receive (up to 2%) and then additionally 20% of any amount we receives over 4%.

The future royalty, milestone and patent prosecution costs under the Melligen Cell License Agreement are: (i) 6% royalty on gross sales and 25% royalty on sublicense gross sales; (ii) milestone payments of $50,000 after the first preclinical study, $100,000 after the successful conclusion of a Phase 1 clinical trial $450,000 after the successful conclusion of a Phase 2 clinical trialinvolving LAPC. The services include regulatory affairs strategy, advice and $3,000,000 after the successful conclusion of a Phase 3 clinical trial; and (iii) 15%follow up work of the costs paid by UTSIND submission to prosecutethe FDA and maintain patentsservices related to the licensed intellectual property.

Contractual Obligations

planned LAPC trial. They also cover a 24-month stability study, which includes the container closure integrity testing, of the clinical trial product syringes. The following table presents certain payments due by us astotal cost is estimated to be approximately $195,000, of January 31, 2018 with respect to our known contractual obligations:

Payments due by period
Contractual Obligations Total  Less than
1 Year
  

1-3

Years

  3-5
Years
  More than
5 Years
 
Capital Leases $  $  $  $  $ 
Operating Leases  52,383   33,084   19,299       
Purchase Obligations               
Other Long-Term Liabilities Reflected on the Company’s Balance Sheet under U.S. GAAP               
Total $52,383  $33,084  $19,299  $  $ 

As of January 31, 2018, we leased office space in Laguna Hills, California under a lease ending August 31, 2019.

Critical Accounting Estimates and Policies

Our Condensed Consolidated Financial Statements are prepared in accordance with U.S. GAAP. In connection with their preparation, we are required to make assumptions and estimates about future events and apply judgments that affect the reported amounts of assets, liabilities, revenue and expenses andwhich the related disclosures. We base our assumptions, estimates and judgments on historical experience, current trends and other factors that management believes toparty portion will be relevant at the time the financial statements are prepared. On a regular basis, management reviews the accounting policies, assumptions, estimates and judgments to ensure that our Condensed Consolidated Financial Statements are presented fairly and in accordance with U.S. GAAP. However, because future events and their effects cannot be determined with certainty, actual results could differ from our assumptions and estimates and such differences could be material.approximately $80,000.

 

We discuss our critical accounting estimates and policies in Part II, Item 7. "Management’s Discussion and Analysis of Financial Condition and Results of Operations" our Annual Report on Form 10-K for the year ended April 30, 2017. There has been no material change in our critical accounting estimates and policies since April 30, 2017.

 

 

 

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New Accounting Pronouncements

 

For a discussion of all recently adopted and recently issued but not yet adopted accounting pronouncements, see Note 32 “Summary of Significant Accounting Policies” of the Notes to our Condensed Consolidated Financial Statements contained in this Report.

 

Available Information

 

Our website is located at www.PharmaCyte.comwww.PharmaCyte.com.. In addition, all of our filings submitted to the Commission, including our Annual Reports on Form 10-K, Quarterly Reports on Form 10-Q, Current Reports on Form 8-K and all of our other reports and statements filed with the Commission are available on the Commission’s web site at www.sec.govwww.sec.gov. Such filings are also available for download free of charge on our website. The contents of the website are not, and are not intended to be, incorporated by reference into this Report or any other report or document filed with the Commission or furnished by us, and any reference to the websites are intended to be inactive textual references only.

 

Item 3.  Quantitative and Qualitative Disclosures About Market Risk.

 

We are exposed to market risks, which may result in potential losses arising from adverse changes in, among other things, foreign exchange rates. We have not taken steps to try and manage foreign exchange rate fluctuations. We do not enter into derivatives or other financial instrumentsThe information called for trading or speculative purposes to manage this risk. As indicated below, we do not believe we are exposed to material market risk with respect to our cash.

We currently have no operations outside the United States, but we have contracted with a Austrianova to manufacture our encapsulated live cell product in Singapore for preclinical studies and in Thailand for clinical trials. Manufacturing and research costs related to these activities are paid for in a combination of U.S. dollars and local currencies. Accordingly, we are subject to limited foreign currency exchange rate risk. Itby Item 3 is not possible to estimate with any degree of accuracy the degree of this risk onrequired for a percentage basis. As of January 31, 2018, we do not believe foreign currency exchange rate risk is a substantial risk at this time due to the limited extent of our operations; however, if we conduct additional clinical trials and seek to manufacture a more significant portion of our product candidates outside of the United States in the future, we could incur significant foreign currency exchange rate risk.smaller reporting company.

As of January 31, 2018, we had cash of approximately $1.5 million. We do not engage in any hedging activities against changes in interest rates or foreign currency exchange rates. Because of the short-term nature of our cash, we do not believe that an immediate 10% increase in interest rates would have any significant impact on the fair value of our cash.

 

Item 4. Controls and Procedures.Procedures

Evaluation of Disclosure Controls and Procedures

 

Our Chief Executive Officer, President and General Counsel, as our principal executive officer (“Chief Executive Officer”), and our Chief Financial Officer, as our principal financial officer (“Chief Financial Officer”), evaluated the effectiveness of our “disclosure controls and procedures,” as such term is defined in Rule 13a-15(e) promulgated under the Securities Exchange Act of 1934, as amended (“Exchange Act”).Act. Disclosure controls and procedures are designed to ensure that the information required to be disclosed in the reports that we file or submit to the Commission pursuant to the Exchange Act are recorded, processed, summarized and reported within the period specified by the Commission’s rules and forms and are accumulated and communicated to our management, including our Chief Executive Officer, as appropriate to allow timely decisions regarding required disclosures. Based upon this evaluation, our Chief Executive Officer and our Chief Financial Officer have concluded that, as of JanuaryJuly 31, 2018,2020, our disclosure controls and procedures were not effective due to the material weaknesses in internal control over financial reporting.

 

A control system, no matter how well conceived and operated, can provide only reasonable, not absolute, assurance that the objectives of the control system are met. Further, the design of a control system must reflect the fact that there are resource constraints, and the benefits of controls must be considered relative to their costs. Because of the inherent limitations in all control systems, no evaluation of controls can provide absolute assurance that all control issues and instances of fraud, if any, within the Company have been detected. These inherent limitations include the realities that judgments in decision-making can be faulty and that breakdowns can occur because of simple error or mistake. Also, controls can be circumvented by the individual acts of some persons, by collusion of two or more people or by management override of the controls. The design of any system of controls is also based in part upon certain assumptions about the likelihood of future events. There can be no assurance that any design will succeed in achieving its stated goals under all potential future conditions.

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Management’s Evaluation ofReport on Internal ControlControls over Financial Reporting

 

Our management is responsible for establishing and maintaining adequate internal controlcontrols over financial reporting as that term is defined in Exchange Act Rules 13a-15(f) and 15d-15(f). Our internal controlcontrols over financial reporting isare designed to provide reasonable assurance regarding the reliability of financial reporting and the preparation of financial statements for external purposes in accordance with U.S. GAAP.

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Under the supervision and with the participation of our Chief Executive Officer and our Chief Financial Officer, management conducted an evaluation of the effectiveness of our internal controlcontrols over financial reporting as of JanuaryJuly 31, 20182020 based on the criteria outlined in Internal Control-Integrated Framework (2013) issued by the Committee of Sponsoring Organizations of the Treadway Commission (“COSO”) and identified the following material weaknesses in internal controlcontrols over financial reporting:

 

·Ineffective communication of internal information with management and members of our Board. We are remediating this weakness by having regularly scheduled meetings with our Board, including our Audit Committee, on at least a quarterly basis. We have implemented management meetings to discuss the status of Company events and improve communication among members of our management.
 ·Insufficient procedures and control documentation to implement control procedures.procedures including lack of timely contract preparation and review. We have undertaken a review process to developdeveloped procedures to provide ample review time of financial information, including contract preparation and review by qualified accounting and finance personnel as well as management.  We have implemented these procedures, determined they are still implementing this processinsufficient and will require more time to fully implement. We will continue to address this issue.review these procedures to determine ways to further improve them.
   
 ·Insufficient segregation of duties of the Chief Financial Officer. We have delegated some of the duties of our Chief Financial Officer to other personnel within the Company.Company and have added review and approval processes performed by the Chief Executive Officer. However, we have determined that we still have insufficient segregation of the duties of our Chief Financial Officer and will continue to review these procedures to determine ways to further improve them given our limited staff.
   
 ·Insufficient information technology controls and documentation. We currently use accounting software which we have determined is inadequate to provide strong controls.the level of controls required by COSO. We are in the process of initiating a review process to fully evaluate the deficiencies in our technology controls and documentation. Based upon the results of such athis review process, we willintend to implement the required remediation measures.measures when it is reasonable to do so.

 

Because of these material weaknesses, our Chief Executive Officer and our Chief Financial Officer concluded that, as of JanuaryJuly 31, 2018,2020, our internal controlcontrols over financial reporting waswere not effective based on the COSO criteria.

 

We have begunare in the process of investigating new procedures and controls for the balance of fiscal year 2018.2021. We plan to make changes to our procedures and controls that we believe are reasonable and reasonably likely to strengthen and materially affect our internal controlcontrols over financial reporting.

 

Prior to the remediation of these material weaknesses, there remains risk that the processes and procedures on which we currently rely will fail to be sufficiently effective, which could result in material misstatement of our financial position or results of operations and require a restatement. Moreover, becauseBecause of the inherent limitations in all control systems, no evaluation of controls-evencontrols - even where we conclude the controls are operating effectively-caneffectively - can provide absolute assurance that all control issues, including instances of fraud, if any, have been detected. These inherent limitations include the realities that judgments in decision-makingdecision making can be faulty and breakdowns can occur because of simple error or mistake. Additionally, controls can be circumvented by the individual acts of some persons,a person, by collusion of two or more people, or by management override of the controls. The design of any system of controls also is based in part upon certain assumptions about the likelihood of future events, andevents; accordingly, there can be no assurance that any design will succeed in achieving its stated goals under all potential future conditions. Over time, our control systems, as we develop them, may become inadequate because of changes in conditions or the degree of compliance with the policies or procedures may deteriorate. Because of the inherent limitations in a cost-effective control system, misstatements due to error or fraud may occur and not be detected and could be material to our financial statements.

 

Changes in Internal ControlControls over Financial Reporting

There were no changes in our internal controlcontrols over financial reporting during the most recent fiscal quarter that have materially affected, or are reasonably likely to materially affect, our internal controlcontrols over financial reporting.

 

The Certifications of our Principal Executive and Principal Financial Officer required in accordance with Rule 13a-14(a) under the Exchange Act and Section 302 of the Sarbanes-Oxley Act of 2002 (“Certifications”) are attached to this Report. The disclosures set forth in this Item 4 contain information concerning: (i) the evaluation of our disclosure controls and procedures, and changes in internal control over financial reporting, referred to in paragraph 4 of the Certifications; and (ii) material weaknesses in the design or operation of our internal control over financial reporting, referred to in paragraph 5 of the Certifications. The Certifications should be read in conjunction with this Item 4 for a more complete understanding of the matters covered by the Certifications.

 

 

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PART II – OTHER INFORMATION

 

Item 1.  Legal Proceedings.

 

We are not currently a party to any material pending legal proceedings. There are no material legal proceedings to which any property of ours is subject.

 

Item 1A.  Risk Factors.

 

In addition to the other information set forth in this Report, you should carefully consider the factors discussed in Part I, Item 1A. “Risk Factors” in our Form 10-K. The information set forth therein and in this Report could materially affect our business, financial position and results of operations. There are no material changes from the risk factors set forth the 10-K, except as follows:

The recently passed comprehensive tax reform bill could adversely affect our business and financial condition.

On December 22, 2017, President Trump signed into law the final version of the tax reform bill commonly known as the “Tax Cuts and Jobs Act,” or the TCJA, that significantly reforms the Internal Revenue Code of 1986, as amended, with many of its provisions effectivecalled for tax years beginning on or after January 1, 2018. The TCJA, among other things, contains significant changes to corporate taxation, including a permanent reduction of the corporate income tax rate, a partial limitation on the deductibility of business interest expense, a limitation of the deduction for net operating loss carryforwards to 80% of current year taxable income, an indefinite net operating loss carryforward and the elimination of the two-year net operating loss carryback, temporary, immediate expensing for certain new investments , and the modification or repeal of many business deductions and credits. We continue to examine the impact this tax reform legislation may have on our business. Notwithstanding the reduction in the corporate income tax rate, the overall impact of the TCJAby Item 1A is uncertain and our business and financial condition could be adversely affected. The impact of this reform on our stockholders is uncertain. Stockholders should consult with their tax advisors regarding the effect of the TCJA and other potential changes to the U.S. Federal tax laws on them.

Our plan to first pursue a Phase 2b clinical trial before a pivotal Phase 3 trial will likely result in additional costs to us and resultant delays in the FDA review process and any future commercialization and marketing, if regulatory approval is obtained.

Based on advice from our consulting oncologists, our Chief Medical Officer and our Advisory Board regarding our planned trial design, we have determined that the data contained in previous clinical trial reports using the Cell-in-a-Box® technology are not enough to fully support a Phase 3 pivotal trial. Therefore, we are designing a Phase 2b clinical trial that, if successful, we believe will provide the information necessaryrequired for a successful Phase 3 pivotal trial and possible accelerated approval. Our determination to first conduct a Phase 2b clinical trial before conducting a pivotal Phase 3 clinical trial will likely result in additional costs to us and resultant delays in the regulatory review process and any future commercialization and marketing, if regulatory approval is obtained.smaller reporting company.

 

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

 

In accordance with the terms of their 2018 compensation agreements, 6,600,000 shares of restricted common stock were awarded to three executives of the Company duringDuring the three months ended JanuaryJuly 31, 2018. These2020, we issued an aggregate of 1.5 million unregistered shares vest monthly overof common stock to three of our directors as disclosed in this Report. The non-cash expense for these share issuances totaled $7,029.

During the three months ended July 31, 2020, we issued an aggregate of 1.5 million stock options to three of our directors pursuant to their DLAs. The non-cash expense for stock options totaled $19,201.

During the three months ended July 31, 2020, we issued an aggregate of 1 million unregistered shares of common stock to four independent contractors pursuant to their professional services agreements. The non-cash expense for these share issuances totaled $4,199.

During the three months ended July 31, 2020, we issued four Common Stock Purchase Warrants to Aeon for Block Trades transactions. The warrants provide Aeon the right to purchase 11,433,333 shares of common stock based upon these Block Trades pursuant to the Aeon Engagement Agreement. We classified these warrants as equity. The warrants have a twelve-month period and are subjectterm of five years with an exercise price of approximately $0.01 per warrant share. Using the Black-Scholes-Merton option pricing model, we determined the aggregate value of these warrants to them continuing service under the agreements.be approximately $67,000. The warrants have a cashless exercise feature.

 

All sharessuch securities were awarded and issued without registration under the Securities Act of 1933, as amended, in reliance upon the exemption afforded by Section 4(a)(2) of the Securitiesthat Act based on the limited number of recipients, our relationship withinvestors, the sophistication of the individuals involved their sophistication and the use of restrictive legends on the shares certificatessecurities issued to prevent a public distribution of the relevant securities. No underwriters were involved in any of these issuances.

 

Item 3.  Defaults Upon Senior Securities.

 

None.

 

Item 4.  Mine Safety Disclosure.

 

Not applicable.

 

Item 5.  Other Information.

 

None.

  

 

 

 

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Item 6.  Exhibits.

 

Exhibit No. Description Location

10.1 Financial Advisory, Offering and At-the-Market Offering Engagement Letter dated February 22, 2018,Right of First Refusal Agreement by and between PharmaCyte Biotech, Inc. and Aeon Capital, Inc..Silver Rock Associates, Inc., dated May 4, 2020 Incorporated by reference from the Company’s Current Report on Form 8-K filed with the SEC on February 22, 2018.Filed herewith
     
10.2 Mutual TerminationAmendment No. 1 to Right of First Refusal Agreement dated January 26, 2018, by and between PharmaCyte Biotech, Inc. and Chardan Capital Markets, LLC.Silver Rock Associates, Inc., dated July 15, 2020 Incorporated by reference from the Company’s Current Report on Form 8-K filed with the SEC on February 22, 2018.
10.3Binding Term Sheet between the Company, Austrianova Singapore Pte. Ltd. and SG Austria Pte. Ltd. dated August 30, 2017.Incorporated by reference from the Company’s Current Report on Form 8-K filed with the SEC on September 6, 2017.Filed herewith
     
31.1 Principal Executive Officer Certification required by Rules 13a-14 and 15d-14 as adopted pursuant to Section 302 of the Sarbanes-Oxley Act of 2002. Filed herewith
     
31.2 Principal Financial Officer Certification required by Rules 13a-14 and 15d-14 as adopted pursuant to Section 302 of the Sarbanes-Oxley Act of 2002. Filed herewith
     
32.1 Certification of Principal Executive Officer pursuant to 18 U.S.C. Section 1350, as adopted pursuant to Section 906 of Sarbanes Oxley Act of 2002. FurnishedFiled herewith
     
32.2 Certification of Principal Financial Officer pursuant to 18 U.S.C. Section 1350, as adopted pursuant to Section 906 of Sarbanes Oxley Act of 2002. FurnishedFiled herewith
     
101. Interactive Data Files for the Company’s Form 10-Q for the period ended JanuaryJuly 31, 20182020 Submitted herewith.

 

 

 

 

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SIGNATURE

SIGNATURES

 

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

 

PharmaCyte Biotech, Inc.

 

March 19, 2018September 11, 2020By:/s/ Kenneth L. Waggoner                           
 Kenneth L. Waggoner
 Chief Executive Officer
 (Duly Authorized Officer and Principal Executive Officer)
  
  
March 19, 2018September 11, 2020By:/s/ Carlos A. Trujillo                                   
 Carlos A. Trujillo
 Chief Financial Officer
 (Duly Authorized Officer and Principal Financial and Principal Accounting Officer)

 

 

 

 

 

 

 

 

 

 

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