1 unchanged sentence
PHARMACYTE BIOTECH, INC.
−Removed: CONDENSED CONSOLIDATED BALANCE SHEETS
+Added: CONDENSED CONSOLIDATED BALANCE
Current assets:
8 unchanged sentences
Accrued expenses
−Removed: Current portion of Small Business Administration –
−Removed: Paycheck Protection Program loan
Total current liabilities
−Removed: Long-term liabilities, less current portion:
−Removed: Small Business Administration –
−Removed: Paycheck Protection Program loan
Total Liabilities
3 unchanged sentences
33,333,334 shares, $ 0.0001 par value;
−Removed: 2,341,410,405 and 1,638,637,839 shares issued and outstanding as of January 31, 2021 and April 30, 2020, respectively
+Added: 1,611,671 and 1,590,084 shares issued and outstanding as of July 31, 2021 and April 30, 2021, respectively
Additional paid-in capital
8 unchanged sentences
PHARMACYTE BIOTECH, INC.
−Removed: CONDENSED CONSOLIDATED STATEMENTS OF
−Removed: Three Months Ended
−Removed: Nine Months Ended
+Added: CONDENSED CONSOLIDATED STATEMENTS
+Added: OF OPERATIONS
+Added: Three Months Ended July 31,
Operating expenses:
6 unchanged sentences
Loss from operations
−Removed: Other expenses:
+Added: ( 1,023,351 )
+Added: Other expense:
Interest expense
5 unchanged sentences
Weighted average shares outstanding basic and diluted
−Removed: 2,337,034,318
−Removed: 1,375,499,976
−Removed: 2,108,274,833
−Removed: 1,284,500,731
See accompanying Notes to Condensed Consolidated
1 unchanged sentence
PHARMACYTE BIOTECH, INC.
−Removed: CONDENSED CONSOLIDATED STATEMENTS OF
−Removed: COMPREHENSIVE LOSS
−Removed: Three Months Ended
−Removed: Nine Months Ended
+Added: CONDENSED CONSOLIDATED STATEMENTS
+Added: OF COMPREHENSIVE LOSS
+Added: Three Months Ended July 31,
$ ( 1,025,418 )
1 unchanged sentence
Other comprehensive income (loss):
−Removed: Foreign currency translation
+Added: Foreign currency translation adjustment
Other comprehensive income (loss)
5 unchanged sentences
PHARMACYTE BIOTECH, INC.
−Removed: CONDENSED CONSOLIDATED STATEMENT OF STOCKHOLDERS'
−Removed: NINE MONTHS ENDED JANUARY 31, 2021 AND
−Removed: A Preferred Stock
−Removed: Comprehensive Income
−Removed: Stockholders’
−Removed: Balance, April 30, 2020
−Removed: 1,638,637,839
−Removed: $ 108,805,062
−Removed: $ (103,858,259 )
−Removed: Shares issued for compensation
−Removed: Shares issued for services
−Removed: Shares issued for cash, net of issuance costs of $198,150
−Removed: Stock-based compensation - options
−Removed: Foreign currency translation adjustment
−Removed: Balance, July 31, 2020
−Removed: 1,875,143,738
−Removed: (104,742,203 )
−Removed: Shares issued for compensation
−Removed: Shares issued for services
−Removed: Shares issued for cash, net of issuances costs of $278,150
−Removed: Stock-based compensation - options
−Removed: Foreign currency translation adjustment
−Removed: Balance, October 31, 2020
−Removed: 2,334,810,405
−Removed: (105,692,395 )
−Removed: Shares issued for compensation
−Removed: Shares issued for services
−Removed: Shares issued for cash
−Removed: Stock-based compensation - options
−Removed: Foreign currency translation adjustment
−Removed: Balance, January 31, 2021
−Removed: 2,341,410,405
−Removed: $ 113,849,337
−Removed: $ (106,449,491 )
−Removed: PHARMACYTE BIOTECH, INC.
−Removed: CONDENSED CONSOLIDATED STATEMENT OF STOCKHOLDERS'
−Removed: EQUITY (continued)
−Removed: NINE MONTHS ENDED JANUARY 31, 2021 AND
−Removed: A Preferred Stock
−Removed: Comprehensive Income
−Removed: Stockholders’
−Removed: Balance, April 30, 2019
+Added: CONDENSED CONSOLIDATED STATEMENT
+Added: OF STOCKHOLDERS' EQUITY
+Added: THREE MONTHS ENDED JULY 31, 2021 AND 2020
+Added: Comprehensive
+Added: Stockholders’
+Added: April 30, 2021
$ 114,109,169
$ ( 107,409,495 )
+Added: issued for compensation
+Added: issued for services
+Added: issued fractions shares -reverse stock split 1 for 1,500
+Added: compensation options
+Added: currency translation adjustment
( 1,025,418 )
−Removed: Shares issued for compensation
−Removed: Shares issued for services
−Removed: Shares issued for cash, net of issuance costs of $70,000
−Removed: Stock-based compensation - options
−Removed: Foreign currency translation adjustment
−Removed: Balance, July 31, 2019
( 1,025,418 )
+Added: July 31, 2021
$ 114,169,131
−Removed: Shares issued for compensation
−Removed: Shares issued for services
−Removed: Shares issued for cash, net of issuances costs of $24,500
−Removed: Stock-based compensation - options
−Removed: Foreign currency translation adjustment
−Removed: Balance, October 31, 2019
$ ( 108,434,913 )
+Added: April 30, 2020
$ 108,968,817
−Removed: Shares issued for compensation
−Removed: Shares issued for services
−Removed: Shares repurchased for cash
−Removed: Stock-based compensation - options
−Removed: Foreign currency translation adjustment
−Removed: Balance, January 31, 2020
$ ( 103,858,259 )
+Added: issued for compensation
+Added: issued for services
+Added: issued for cash, net of issuance costs of $ 194,150
+Added: compensation options
+Added: currency translation adjustment
+Added: July 31, 2020
$ 111,006,385
3 unchanged sentences
PHARMACYTE BIOTECH, INC.
−Removed: CONDENSED CONSOLIDATED STATEMENTS OF
−Removed: Nine Months Ended January 31,
+Added: CONDENSED CONSOLIDATED STATEMENTS
+Added: OF CASH FLOWS
+Added: Three Months Ended July 31,
Cash flows from operating activities:
2 unchanged sentences
Adjustments to reconcile net loss to net cash used in operating activities:
−Removed: Shares issued for services
−Removed: Shares issued for compensation
−Removed: Stock-based compensation –
+Added: Stock issued for services
+Added: Stock issued for compensation
+Added: Stock-based compensation – options
Change in assets and liabilities:
−Removed: Decrease in prepaid expenses and other current assets
+Added: (Increase) decrease in prepaid expenses and other current assets
Increase (decrease) in accounts payable
−Removed: Increase (decrease) in accrued expenses
+Added: Decrease in accrued expenses
Net cash used in operating activities
+Added: ( 1,241,221 )
Cash flows from investing activities:
1 unchanged sentence
Cash flows from financing activities:
−Removed: Payment of insurance financing loan
−Removed: Proceeds from sale of Series A Preferred Stock
−Removed: Use of funds from purchase of Series A preferred stock
+Added: Use of funds for payment of insurance financing loan
Proceeds from sale of common stock, net of issuance costs
2 unchanged sentences
Net increase (decrease) in cash
+Added: ( 1,242,836 )
Cash at beginning of the period
3 unchanged sentences
Cash paid during the periods for interest
+Added: Supplemental information of non-cash activities:
+Added: Prepaid expenses included in accounts payable
See accompanying Notes to Condensed Consolidated
1 unchanged sentence
PHARMACYTE BIOTECH, INC.
−Removed: NOTES TO CONDENSED CONSOLIDATED FINANCIAL
−Removed: NOTE 1 –
−Removed: NATURE OF BUSINESS
+Added: NOTES TO CONDENSED CONSOLIDATED
+Added: FINANCIAL STATEMENTS
+Added: NOTE 1 – NATURE OF BUSINESS
PharmaCyte Biotech, Inc.
−Removed: (“Company”)
−Removed: is a biotechnology company focused on developing cellular therapies for cancer and diabetes based upon a proprietary cellulose-based
−Removed: live cell encapsulation technology known as “Cell-in-a-Box ®
−Removed: The Cell-in-a-Box ®
−Removed: is intended to be used as a platform upon which therapies for several types of cancer, including locally advanced, inoperable,
−Removed: pancreatic cancer (“LAPC”), and Type 1 and insulin dependent Type 2 diabetes will be developed.
−Removed: The Company is developing therapies for
−Removed: pancreatic and other solid cancerous tumors by using genetically engineered live human cells that it believes are capable of converting
−Removed: a cancer prodrug into its cancer-killing form, encapsulating those cells using the Cell-in-a-Box ®
−Removed: technology and
−Removed: placing those capsules in the body as close as possible to the tumor.
−Removed: The Company believes that when the cancer prodrug is administered
−Removed: to a patient with a particular type of cancer that may be affected by the prodrug, the killing of the patient’s tumor may
−Removed: be optimized.
−Removed: The Company is also examining ways to exploit
−Removed: the benefits of the Cell-in-a-Box ®
−Removed: technology to develop therapies for cancer that involve prodrugs based upon certain
−Removed: constituents of the Cannabis plant;
−Removed: these constituents are of the class of compounds known as “cannabinoids.”
−Removed: Until the U.S.
−Removed: Food and Drug Administration (“FDA”) allows the Company to commence the clinical trial involving LAPC
−Removed: described in the Company’s Investigational New Drug Application (“IND”) for which the FDA has placed a clinical
−Removed: hold, the Company is not spending any further resources developing this program.
−Removed: In addition, the Company is developing
−Removed: a therapy to delay the production and accumulation of malignant ascites fluid that results from many types of abdominal cancerous
−Removed: Malignant ascites fluid is secreted by abdominal cancerous tumors into the abdomen after the tumors have reached a certain
−Removed: stage of growth.
−Removed: This fluid contains cancer cells that can seed and form new tumors throughout the abdomen.
−Removed: This fluid accumulates
−Removed: in the abdominal cavity, causing swelling of the abdomen, severe breathing difficulties and extreme pain.
−Removed: The Company is using its therapy for pancreatic
−Removed: cancer to determine if it can prevent or delay the production and accumulation of malignant ascites fluid.
−Removed: As with the Company’s
−Removed: Cannabis program, until the FDA allows it to commence the clinical trial involving LAPC described in its IND for which the
−Removed: FDA has placed a clinical hold, the Company is not spending any further resources developing this program.
−Removed: The Company is also developing a therapy
−Removed: for Type 1 diabetes and insulin-dependent Type 2 diabetes.
−Removed: The Company’s diabetes therapy consists of encapsulated genetically
−Removed: modified insulin-producing cells.
−Removed: The encapsulation will be done using the Cell-in-a-Box ®
−Removed: these cells in the body is designed to function as a bio-artificial pancreas for purposes of insulin production.
−Removed: As with the two
−Removed: previous programs, the Company is not spending any further resources developing this program until the FDA allows the Company to
−Removed: commence the clinical trial involving LAPC described in its IND for which the FDA has placed a clinical hold.
−Removed: Finally, the Company had licensed (“Hai
−Removed: Kang License Agreement”) from Hai Kang Life Corporation (“Hai Kang”) the right to certain technology owned or
−Removed: controlled by Hai Kang related to SARS-Cov2 COVID-19 diagnostic kits (“Kits”).
−Removed: On November 19, 2020, the Company terminated
−Removed: the Hai Kang License Agreement.
+Added: is a biotechnology company focused on developing cellular therapies for cancer and diabetes based upon a proprietary cellulose-based live
+Added: cell encapsulation technology known as “Cell-in-a-Box ® ”.
+Added: The Cell-in-a-Box ® technology is intended
+Added: to be used as a platform upon which therapies for several types of cancer, including locally advanced, inoperable, non-metastatic pancreatic
+Added: cancer (“LAPC”) will be developed.
+Added: The current generation of the Company’s product candidate is referred to as “CypCaps™”.
+Added: On September 1, 2020, the Company submitted an Investigational New Drug Application (“IND”) to the U.S.
+Added: Food and Drug Administration
+Added: (“FDA”) for a planned Phase 2b clinical trial in LAPC.
+Added: On October 1, 2020, the Company received notice from the FDA that it
+Added: had placed the IND on clinical hold.
+Added: On October 30, 2020, the FDA sent a letter to the Company setting forth the reasons for the clinical
+Added: hold and specific guidance on what the Company must do to have the clinical hold lifted.
+Added: To lift the clinical hold, the FDA has informed
+Added: the Company that it needs to conduct several additional preclinical studies and assays.
+Added: The FDA also requested additional information
+Added: regarding several topics, including DNA sequencing data, manufacturing information and product release specifications.
+Added: The Company is
+Added: also in the process of conducting these studies and assays and gathering additional information to submit to the FDA.
+Added: See “Our Investigational
+Added: New Drug Application and the Clinical Hold” below.
+Added: The Cell-in-a-Box ® encapsulation
+Added: technology potentially enables genetically engineered live human cells to be used as a means to produce various biologically active molecules.
+Added: The technology is intended to result in the formation of pinhead sized cellulose-based porous capsules in which genetically modified live
+Added: human cells can be encapsulated and maintained.
+Added: In a laboratory setting, this proprietary live cell encapsulation technology has been
+Added: shown to create a micro-environment in which encapsulated cells survive and flourish.
+Added: They are protected from environmental challenges,
+Added: such as the sheer forces associated with bioreactors and passage through catheters and needles, which we believe enables greater growth
+Added: and production.
+Added: The capsules are largely composed of cellulose (cotton) and are bio inert.
+Added: The Company is developing therapies for pancreatic
+Added: and other solid cancerous tumors by using genetically engineered live human cells that we believe are capable of converting a cancer prodrug
+Added: into its cancer-killing form.
+Added: The Company encapsulate those cells using the Cell-in-a-Box ® technology and place those capsules
+Added: in the body as close as possible to the tumor.
+Added: In this way, the Company believes that when a cancer prodrug is administered to a patient
+Added: with a particular type of cancer that may be affected by the prodrug, the killing of the patient’s cancerous tumor may be optimized.
+Added: In addition, the Company has been exploring ways
+Added: to delay the production and accumulation of malignant ascites fluid that results from many types of abdominal cancerous tumors.
+Added: ascites fluid is secreted by abdominal cancerous tumors into the abdomen after the tumors have reached a certain stage of growth.
+Added: fluid contains cancer cells that can seed and form new tumors throughout the abdomen.
+Added: This fluid accumulates in the abdominal cavity,
+Added: causing swelling of the abdomen, severe breathing difficulties and extreme pain.
+Added: The Company has also been developing a potential
+Added: therapy for Type 1 diabetes and insulin-dependent Type 2 diabetes.
+Added: The Company’s product candidate for the treatment of diabetes
+Added: consists of encapsulated genetically modified insulin-producing cells.
+Added: The encapsulation will be done using the Cell-in-a-Box ® technology.
+Added: Implanting these cells in the body is designed to function as a bio-artificial pancreas for purposes of insulin production.
+Added: The Company has also been considering ways to
+Added: exploit the benefits of the Cell-in-a-Box ® technology to develop therapies for cancer that involve prodrugs based
+Added: upon certain constituents of the Cannabis plant (“Cannabis Program”);
+Added: these constituents are of the class
+Added: of compounds known as “cannabinoids”.
+Added: (i) the FDA allows the Company to commence
+Added: a clinical trial in LAPC described in its IND for which the FDA has placed a clinical hold;
+Added: and (ii) the Company validates its Cell-in-a-Box ®
+Added: encapsulation technology in its planned Phase 2b clinical trial in LAPC, the Company is not spending any further resources developing
+Added: the Cannabis Program.
Clinical Hold
−Removed: On September 1, 2020, the Company submitted
−Removed: an IND to the FDA for a planned Phase 2b clinical trial in LAPC.
−Removed: Shortly thereafter, the Company received Information Requests
−Removed: from the FDA related to the IND.
+Added: On September 1, 2020, the Company submitted an
+Added: IND to the FDA for a planned Phase 2b clinical trial in LAPC.
+Added: Shortly thereafter, the Company received Information Requests from the FDA
+Added: related to the IND.
The Company timely responded to all information requests.
−Removed: On October 1, 2020, the Company received
−Removed: notice that the FDA had placed the IND on clinical hold.
−Removed: On October 30, 2020, the FDA sent a letter
−Removed: to the Company setting forth the reasons for the clinical hold and specific guidance on what the Company must do to have the clinical
−Removed: In order to lift the clinical hold, the
−Removed: FDA has informed the Company that it needs to conduct several additional preclinical studies.
−Removed: The FDA also requested additional
−Removed: information regarding several topics, including sequencing data, manufacturing information and product release specifications.
−Removed: In addition, the FDA requested that several
−Removed: items not related to the clinical hold be addressed through the submission of an IND amendment.
−Removed: Specifically, the FDA requested
−Removed: that the Company perform qualification studies for the drug substance filling step to ensure that the product remains sterile and
−Removed: stable during the filling process.
−Removed: The FDA also requested additional information, discussion and clarification on several other
−Removed: Since October 30, 2020, there has been
−Removed: no further communication with the FDA regarding the clinical hold.
−Removed: The Company has assembled a scientific team to address the FDA
−Removed: requests related to the clinical hold.
+Added: On October 1, 2020, the Company received notice
+Added: that the FDA had placed the IND on clinical hold.
+Added: On October 30, 2020, the FDA sent a letter to
+Added: the Company setting forth the reasons for the clinical hold and specific guidance on what the Company must do to have the clinical hold
+Added: In order to lift the clinical hold, the FDA has
+Added: informed the Company that it needs to conduct several additional preclinical studies.
+Added: The FDA also requested additional information
+Added: regarding several topics, including sequencing data, manufacturing information and product release specifications.
+Added: In addition, the FDA requested that several items
+Added: not related to the clinical hold be addressed through the submission of an IND amendment.
+Added: Specifically, the FDA requested that the Company
+Added: perform qualification studies for the drug substance filling step to ensure that the product remains sterile and stable during the filling
+Added: The FDA also requested additional information, discussion and clarification on several other topics.
+Added: Since October 30, 2020, there has been no further
+Added: communication with the FDA regarding the clinical hold.
+Added: The Company has assembled a scientific team to
+Added: address the FDA requests related to the clinical hold.
That team is working through an extensive list of items that the FDA requested.
−Removed: things, the Company has successfully completed a 9-month product stability study, commenced physical parameter testing for CypCaps™
−Removed: and commenced additional studies for the sequence of DNA encoding of its encapsulated cells.
−Removed: The Company has also designed the
−Removed: biocompatibility tests for cytotoxicity, sensitization, irritation, acute systemic toxicity, material-mediated pyrogenicity, subacute/subchronic
+Added: Among other things, the Company has successfully completed a 9-month product stability study, commenced physical parameter testing for
+Added: CypCaps™ and commenced additional studies for the sequence of DNA encoding of its encapsulated cells.
+Added: The Company has also designed
+Added: the biocompatibility tests for cytotoxicity, sensitization, irritation, acute systemic toxicity, material-mediated pyrogenicity, subacute/subchronic
toxicity, genotoxicity and implantation.
−Removed: In addition, the Company has begun a compression and swelling study of CypCaps™,
−Removed: designed a study to determine if CypCaps™
−Removed: are adversely affected by contrast medium and designed a study to show the catheters
−Removed: used to implant CypCaps™
−Removed: do not adversely impact the encapsulated cells.
−Removed: See Management’s Discussion and Analysis
−Removed: of Financial Condition and Results of Operations-Clinical Hold for a further discussion of the clinical hold.
−Removed: Impact of the COVID-19 Pandemic on the Company’s Operations
−Removed: The coronavirus SARS-Cov2 pandemic (“COVID-19”)
+Added: In addition, the Company has begun a compression and swelling study of CypCaps™, designed
+Added: a study to determine if CypCaps™ are adversely affected by contrast medium and designed a study to show the catheters used to implant
+Added: CypCaps™ do not adversely impact the encapsulated cells.
+Added: Impact of the COVID-19 Pandemic on the Company’s Operations
+Added: The coronavirus SARS-Cov2 pandemic (“COVID-19”)
is causing significant, industry-wide delays in clinical trials.
−Removed: Although the Company is not yet in a clinical trial, the Company
−Removed: has filed an IND with the FDA to commence a clinical trial in LAPC.
−Removed: While the IND has been placed on clinical hold by the FDA,
−Removed: the Company has assessed the impact of COVID-19 on its operations.
+Added: Although the Company is not yet in a clinical trial, the Company has
+Added: filed an IND with the FDA to commence a clinical trial in LAPC.
+Added: While the IND has been placed on clinical hold by the FDA, the Company
+Added: has assessed the impact of COVID-19 on its operations.
Currently, many clinical trials are being delayed due to COVID-19.
−Removed: There are numerous reasons for these delays.
−Removed: For example, patients have shown a reluctance to enroll or continue in a clinical
−Removed: trial due to fear of exposure to COVID-19 when they are in a hospital or doctor’s office.
−Removed: There are local, regional and state-wide
−Removed: orders and regulations restricting usual normal activity by people.
−Removed: These discourage and interfere with patient visits to a doctor’s
−Removed: office if the visit is not COVID-19 related.
−Removed: Healthcare providers and health systems are shifting their resources away from clinical
−Removed: trials toward the care of COVID-19 patients.
−Removed: The FDA and other healthcare providers are making product candidates for the treatment
−Removed: of COVID-19 a priority over product candidates unrelated to COVID-19.
−Removed: As of the date of this Report on Form 10-Q (“Report”),
−Removed: the COVID-19 pandemic has had an impact upon the Company’s operations, although the Company believes that impact is not material.
−Removed: The impact primarily relates to delays in tasks associated with the preparation of the Company’s responses to the clinical
−Removed: hold, including all requested preclinical studies.
−Removed: There may be further delays in generating responses to the requests from the
−Removed: FDA related to the clinical hold.
+Added: There are numerous
+Added: reasons for these delays.
+Added: For example, patients have shown a reluctance to enroll or continue in a clinical trial due to fear of exposure
+Added: to COVID-19 when they are in a hospital or doctor’s office.
+Added: There are local, regional and state-wide orders and regulations restricting
+Added: usual normal activity by people.
+Added: These discourage and interfere with patient visits to a doctor’s office if the visit is not COVID-19
+Added: Healthcare providers and health systems are shifting their resources away from clinical trials toward the care of COVID-19 patients.
+Added: The FDA and other healthcare providers are making product candidates for the treatment of COVID-19 a priority over product candidates
+Added: unrelated to COVID-19.
+Added: As of the date of the accompanying condensed consolidated financial statements and related footnotes on Form 10-Q
+Added: (“Report”), the COVID-19 pandemic has had an impact upon the Company’s operations, although the Company believes that
+Added: impact is not material.
+Added: The impact primarily relates to delays in tasks associated with the preparation of the Company’s responses
+Added: to the clinical hold, including all requested preclinical studies.
+Added: There may be further delays in generating responses to the requests
+Added: from the FDA related to the clinical hold.
As a result of the COVID-19 pandemic, commencement
−Removed: of the Company’s planned clinical trial to treat LAPC may be delayed beyond the lifting of the clinical hold should that
+Added: of the Company’s planned clinical trial to treat LAPC may be delayed beyond the lifting of the clinical hold should that occur.
Also, enrollment may be difficult for the reasons discussed above.
−Removed: In addition, after enrollment in the trial, if patients
−Removed: contract COVID-19 during their participation in the trial or are subject to isolation or shelter in place restrictions, this may
−Removed: cause them to drop out of our clinical trial, miss scheduled therapy appointments or follow-up visits or otherwise fail to follow
−Removed: the clinical trial protocol.
−Removed: If patients are unable to follow the clinical trial protocol or if the trial results are otherwise
−Removed: affected by the consequences of the COVID-19 pandemic on patient participation or actions taken to mitigate COVID-19 spread, the
−Removed: integrity of data from the clinical trial may be compromised or not be accepted by the FDA.
−Removed: This could further adversely impact
−Removed: or delay the Company’s clinical development program.
−Removed: It is highly speculative in projecting
−Removed: the effects of COVID-19 on the Company’s clinical development program and the Company generally.
−Removed: The effects of COVID-19
−Removed: quickly and dramatically change over time.
−Removed: Its evolution is difficult to predict, and no one is able to say with certainty when
−Removed: the pandemic will subside.
+Added: In addition, after enrollment in the trial, if patients contract COVID-19
+Added: during their participation in the trial or are subject to isolation or shelter in place restrictions, this may cause them to drop out
+Added: of our clinical trial, miss scheduled therapy appointments or follow-up visits or otherwise fail to follow the clinical trial protocol.
+Added: If patients are unable to follow the clinical trial protocol or if the trial results are otherwise affected by the consequences of the
+Added: COVID-19 pandemic on patient participation or actions taken to mitigate COVID-19 spread, the integrity of data from the clinical trial
+Added: may be compromised or not be accepted by the FDA.
+Added: This could further adversely impact or delay the Company’s clinical development
+Added: It is highly speculative in projecting the effects
+Added: of COVID-19 on the Company’s clinical development program and the Company generally.
+Added: The effects of COVID-19 quickly and dramatically
+Added: change over time.
+Added: Its evolution is difficult to predict, and no one is able to say with certainty when the pandemic will subside.
Company Background
1 unchanged sentence
In 2013, the Company restructured its operations to focus on biotechnology.
−Removed: The restructuring resulted in the Company
−Removed: focusing all its efforts upon the development of a novel, effective and safe way to treat cancer and diabetes.
−Removed: In January 2015,
−Removed: the Company changed its name from Nuvilex, Inc.
+Added: The restructuring resulted in the Company focusing
+Added: all its efforts upon the development of a novel, effective and safe way to treat cancer and diabetes.
+Added: In January 2015, the Company changed
+Added: its name from Nuvilex, Inc.
to PharmaCyte Biotech, Inc.
to reflect the nature of its current business.
−Removed: NOTE 2 –
−Removed: SUMMARY OF SIGNIFICANT
−Removed: ACCOUNTING POLICIES
−Removed: Principles of Consolidation and Basis
−Removed: of Presentation
−Removed: The Condensed Consolidated Financial Statements
−Removed: include the accounts of the Company and its wholly owned subsidiaries.
−Removed: The Company operates independently and through four wholly
−Removed: owned subsidiaries:
−Removed: (i) Bio Blue Bird AG;
+Added: Increase in Authorized Shares and Reverse Stock
+Added: On July 2, 2021, pursuant to stockholder approval
+Added: at the Annual Meeting of Stockholders, the Company filed with the Secretary of State of the State of Nevada a Certificate of Amendment
+Added: to its Articles of Incorporation, as amended, to increase the number of authorized shares to fifty billion ten million (50,010,000,000)
+Added: shares, of which fifty billion (50,000,000,000) shares, with a par value of $0.0001 per share are designated as common stock and of which
+Added: ten million (10,000,000) shares, with a par value of $0.0001 per share, are designated as preferred stock.
+Added: Effective July 12, 2021, pursuant to the approval
+Added: by the Board of Directors, the Company filed with the Secretary of State of Nevada a Certificate of Change to the Articles of Incorporation,
+Added: to effect a 1-for-1,500 reverse stock split
+Added: of the Company’s common stock.
+Added: The reverse stock split decreased the number of authorized
+Added: shares of common stock from fifty billion ( 50,000,000,000 ) shares to thirty-three million three hundred thirty-three thousand three hundred
+Added: thirty-four ( 33,333,334 ) shares, with a par value of $ 0.0001 per share.
+Added: Any fractional shares resulting from the reverse stock split were rounded
+Added: up to the next whole share.
+Added: Except as otherwise indicated, all share and per share information
+Added: in the accompanying consolidated financial statements and related footnotes gives effect to the reverse stock split of the Company’s common stock.
+Added: NOTE 2 – SUMMARY OF SIGNIFICANT ACCOUNTING
+Added: Principles of Consolidation and Basis of Presentation
+Added: The consolidated financial statements include
+Added: the accounts of the Company and its wholly owned subsidiaries.
+Added: The Company operates independently and through four wholly owned subsidiaries:
+Added: (i) Bio Blue Bird;
(ii) PharmaCyte Biotech Europe Limited;
1 unchanged sentence
and (iv) Viridis Biotech, Inc.
−Removed: and are prepared in accordance with United States Generally Accepted Accounting Principles (“U.S.
−Removed: GAAP”) and the rules and regulations of the United States Securities and Exchange Commission (“Commission”).
−Removed: Intercompany balances and transactions are eliminated.
−Removed: The Company’s 14.5% investment in SG Austria is presented on the cost
−Removed: method of accounting.
−Removed: Use of Estimates
−Removed: The preparation of financial statements
−Removed: in accordance with U.S.
−Removed: GAAP requires the use of estimates and assumptions that affect the reported amounts of assets and liabilities,
−Removed: disclosure of contingent assets and liabilities known to exist as of the date the financial statements are published and the reported
−Removed: amounts of revenues and expenses during the reporting period.
−Removed: On an ongoing basis, the Company evaluates these estimates including
−Removed: those related to fair values of financial instruments, intangible assets, fair value of stock-based awards, income taxes and contingent
−Removed: liabilities, among others.
−Removed: Uncertainties with respect to such estimates and assumptions are inherent in the preparation of the
−Removed: Company’s Condensed Consolidated Financial Statements;
−Removed: accordingly, it is possible that the actual results could differ from
−Removed: these estimates and assumptions, which could have a material effect on the reported amounts of the Company’s condensed consolidated
−Removed: financial position and results of operations.
+Added: and are prepared in accordance with U.S.
+Added: GAAP and the rules and regulations of the Commission.
+Added: Upon consolidation, intercompany balances
+Added: and transactions are eliminated.
+Added: The Company’s 14.5 % investment in SG Austria is presented on the cost method of accounting.
+Added: Use of Estimates in the Preparation of Financial
+Added: The preparation of financial statements in accordance
+Added: GAAP requires the use of estimates and assumptions that affect the reported amounts of assets and liabilities, disclosure of
+Added: contingent assets and liabilities known to exist as of the date the financial statements are published and the reported amounts of revenues
+Added: and expenses during the reporting period.
+Added: Uncertainties with respect to such estimates and assumptions are inherent in the preparation
+Added: of the Company’s consolidated financial statements;
+Added: accordingly, it is possible that the actual results could differ from these
+Added: estimates and assumptions, which could have a material effect on the reported amounts of the Company’s consolidated financial position
+Added: and results of operations.
+Added: The severity, magnitude and duration, as well as the economic consequences of the COVID-19 pandemic, are uncertain,
+Added: rapidly changing and difficult to predict.
+Added: Therefore, the Company’s accounting estimates and assumptions may change over time in
+Added: response to the COVID-19 pandemic and may change materially in future periods.
Intangible Assets
−Removed: The Financial Accounting Standards Board
−Removed: ("FASB") standard on goodwill and other intangible assets prescribes a two-step process for impairment testing of goodwill
−Removed: and indefinite-lived intangibles, which is performed annually, as well as when an event triggering impairment may have occurred.
−Removed: The first step tests for impairment, while the second step, if necessary, measures the impairment.
−Removed: The Company has elected to perform
−Removed: its annual analysis at the end of its reporting year.
−Removed: The Company’s intangible assets are
−Removed: licensing agreements related to the Cell-in-a-Box ®
−Removed: technology for $1,549,427 and the diabetes license for $2,000,000
−Removed: for an aggregate total of $3,549,427.
−Removed: These intangible assets have an indefinite
+Added: The Financial Accounting Standards Board (“FASB”)
+Added: standard on goodwill and other intangible assets prescribes a two-step process for impairment testing of goodwill and indefinite-lived
+Added: intangibles, which is performed annually, as well as when an event triggering impairment may have occurred.
+Added: The first step tests for impairment,
+Added: while the second step, if necessary, measures the impairment.
+Added: The Company has elected to perform its annual analysis at the end of its
+Added: reporting year.
+Added: The Company’s intangible assets are licensing
+Added: agreements related to the Cell-in-a-Box ® technology for $ 1,549,427 and diabetes license for $ 2,000,000 for an aggregate
+Added: total of $ 3,549,427 .
+Added: These intangible assets have an indefinite life;
therefore, they are not amortizable.
−Removed: The Company concluded that there was no
−Removed: impairment of the carrying value of the intangibles for the nine months ended January 31, 2021 and 2020.
+Added: The Company concluded that there was no impairment
+Added: of the carrying value of the intangible assets for the three months ended July 31, 2021 and 2020, respectively.
Impairment of Long-Lived Assets
−Removed: The Company evaluates long-lived assets
−Removed: for impairment whenever events or changes in circumstances indicate that the carrying value of an asset may not be fully recoverable.
−Removed: If the estimated future cash flows (undiscounted and without interest charges) from the use of an asset are less than carrying
−Removed: value, a write-down would be recorded to reduce the related asset to its estimated fair value.
−Removed: No impairment was identified or
−Removed: recorded during the nine months ended January 31, 2021 and 2020.
+Added: The Company evaluates long-lived assets for
+Added: impairment whenever events or changes in circumstances indicate that the carrying value of an asset may not be fully recoverable.
+Added: the estimated future cash flows (undiscounted and without interest charges) from the use of an asset are less than carrying value, a
+Added: write-down would be recorded to reduce the related asset to its estimated fair value.
+Added: No impairment was identified or recorded for
+Added: three months ended July 31, 2021 and 2020.
Fair Value of Financial Instruments
−Removed: For certain of the Company’s non-derivative
−Removed: financial instruments, including cash, accounts payable and accrued expenses, the carrying amount approximates fair value due to
−Removed: the short-term maturities of these instruments.
−Removed: Accounting Standards Codification ("ASC")
−Removed: Topic 820, “Fair Value Measurements and Disclosures,”
−Removed: requires disclosure of the fair value of financial instruments
−Removed: held by the Company.
−Removed: ASC Topic 825, “Financial Instruments,”
−Removed: defines fair value, and establishes a three-level valuation
−Removed: hierarchy for disclosures of fair value measurement that enhances disclosure requirements for fair value measures.
−Removed: amounts reported in the condensed consolidated balance sheets for current liabilities qualify as financial instruments and are
−Removed: a reasonable estimate of their fair values because of the short period between the origination of such instruments and their expected
−Removed: realization and their current market rate of interest.
+Added: For certain of the Company’s non-derivative
+Added: financial instruments, including cash, accounts payable and accrued expenses, the carrying amount approximates fair value due to the short-term
+Added: maturities of these instruments.
+Added: Accounting Standards Codification ("ASC")
+Added: Topic 820, “Fair Value Measurements and Disclosures,” requires disclosure of the fair value of financial instruments held
+Added: by the Company.
+Added: ASC Topic 825, “Financial Instruments,” defines fair value, and establishes a three-level valuation hierarchy
+Added: for disclosures of fair value measurement that enhances disclosure requirements for fair value measures.
+Added: The carrying amounts reported
+Added: in the consolidated balance sheets for current liabilities qualify as financial instruments and are a reasonable estimate of their fair
+Added: values because of the short period between the origination of such instruments and their expected realization and their current market
+Added: rate of interest.
The three levels of valuation hierarchy are defined as follows:
2 unchanged sentences
Unobservable inputs in which there is little or no market data, which require the reporting entity to develop its own assumptions.
−Removed: Deferred taxes are calculated using the
−Removed: liability method whereby deferred tax assets are recognized for deductible temporary differences and operating loss and tax credit
−Removed: carry forwards, and deferred tax liabilities are recognized for taxable temporary differences.
−Removed: Temporary differences are the differences
−Removed: between the reported amounts of assets and liabilities and their tax bases.
−Removed: Deferred tax assets are reduced by a valuation allowance
−Removed: 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.
−Removed: Deferred tax assets and liabilities are adjusted for the effects of changes in tax laws and rates on the date of enactment.
+Added: Deferred taxes are calculated using the liability
+Added: method whereby deferred tax assets are recognized for deductible temporary differences and operating loss and tax credit carry forwards,
+Added: and deferred tax liabilities are recognized for taxable temporary differences.
+Added: Temporary differences are the differences between the reported
+Added: amounts of assets and liabilities and their tax bases.
+Added: Deferred tax assets are reduced by a valuation allowance when, in the opinion of
+Added: management, it is more-likely-than-not that some portion or all the deferred tax assets will not be realized.
+Added: Deferred tax assets and
+Added: liabilities are adjusted for the effects of changes in tax laws and rates on the date of enactment.
+Added: A valuation allowance is provided for deferred
+Added: income tax assets when, in management’s judgment, based upon currently available information and other factors, it is more likely
+Added: 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
−Removed: allowance is based on an on-going evaluation of current information including, among other things, historical operating results,
−Removed: estimates of future earnings in different taxing jurisdictions and the expected timing of the reversals of temporary differences.
−Removed: The Company believes the determination to record a valuation allowance to reduce a deferred income tax asset is a significant accounting
−Removed: estimate because it is based on, among other things, an estimate of future taxable income in the U.S.
−Removed: and certain other jurisdictions,
−Removed: which is susceptible to change and may or may not occur, and because the impact of adjusting a valuation allowance may be material.
−Removed: In determining when to release the valuation allowance established against the Company’s net deferred income tax assets,
−Removed: the Company considers all available evidence, both positive and negative.
−Removed: Consistent with the Company’s policy, and because
−Removed: of the Company’s history of operating losses, the Company does not currently recognize the benefit of all its deferred tax
−Removed: assets, including tax loss carry forwards, which may be used to offset future taxable income.
−Removed: The Company continually assesses
−Removed: its ability to generate sufficient taxable income during future periods in which deferred tax assets may be realized.
−Removed: Company believes it is more-likely-than-not that it will recover its deferred tax assets, the Company will reverse the valuation
−Removed: allowance as an income tax benefit in the Condensed Consolidated Statements of Operations.
−Removed: GAAP method of accounting for
−Removed: uncertain tax positions utilizes a two-step approach to evaluate tax positions.
−Removed: Step one, recognition, requires evaluation of the
−Removed: tax position to determine if based solely on technical merits it is more-likely-than-not to be sustained upon examination.
−Removed: two, measurement, is addressed only if a position is more-likely-than-not to be sustained.
−Removed: In step two, the tax benefit is measured
−Removed: as the largest amount of benefit, determined on a cumulative probability basis, which is more-likely-than-not to be realized upon
−Removed: ultimate settlement with tax authorities.
−Removed: If a position does not meet the more-likely-than-not threshold for recognition in step
−Removed: one, no benefit is recorded until the first subsequent period in which the more-likely-than-not standard is met, the issue is resolved
−Removed: with the taxing authority or the statute of limitations expires.
−Removed: Positions previously recognized are derecognized when the Company
−Removed: subsequently determines the position no longer is more-likely-than-not to be sustained.
−Removed: Evaluation of tax positions, their technical
−Removed: merits and measurements using cumulative probability are highly subjective management estimates.
−Removed: Actual results could differ materially
−Removed: from these estimates.
−Removed: On March 27, 2020, Congress enacted the
−Removed: “Coronavirus Aid, Relief and Economic Security ("CARES") Act”
−Removed: to provide certain relief as a result of COVID-19.
+Added: allowance is based on an on-going evaluation of current information including, among other things, historical operating results, estimates
+Added: of future earnings in different taxing jurisdictions and the expected timing of the reversals of temporary differences.
+Added: The Company believes
+Added: the determination to record a valuation allowance to reduce a deferred income tax asset is a significant accounting estimate because it
+Added: is based on, among other things, an estimate of future taxable income in the U.S.
+Added: and certain other jurisdictions, which is susceptible
+Added: to change and may or may not occur, and because the impact of adjusting a valuation allowance may be material.
+Added: In determining when to
+Added: release the valuation allowance established against the Company’s net deferred income tax assets, the Company considers all available
+Added: evidence, both positive and negative.
+Added: Consistent with the Company’s policy, and because of the Company’s history of operating
+Added: losses, the Company does not currently recognize the benefit of all its deferred tax assets, including tax loss carry forwards, which
+Added: may be used to offset future taxable income.
+Added: The Company continually assesses its ability to generate sufficient taxable income during
+Added: future periods in which deferred tax assets may be realized.
+Added: When the Company believes it is more likely than not that it will recover
+Added: its deferred tax assets, the Company will reverse the valuation allowance as an income tax benefit in the statements of operations.
+Added: GAAP method of accounting for uncertain
+Added: tax positions utilizes a two-step approach to evaluate tax positions.
+Added: Step one, recognition, requires evaluation of the tax position to
+Added: determine if based solely on technical merits it is more likely than not to be sustained upon examination.
+Added: Step two, measurement, is addressed
+Added: only if a position is more likely than not to be sustained.
+Added: In step two, the tax benefit is measured as the largest amount of benefit,
+Added: determined on a cumulative probability basis, which is more likely than not to be realized upon ultimate settlement with tax authorities.
+Added: 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
+Added: period in which the more likely than not standard is met, the issue is resolved with the taxing authorities or the statute of limitations
+Added: Positions previously recognized are derecognized when the Company subsequently determines the position no longer is more likely
+Added: than not to be sustained.
+Added: Evaluation of tax positions, their technical merits and measurements using cumulative probability are highly
+Added: subjective management estimates.
+Added: Actual results could differ materially from these estimates.
+Added: On March 27, 2020, Congress enacted the Coronavirus
+Added: Aid, Relief and Economic Security ("CARES") Act to provide certain relief as a result of the Coronavirus Disease 2019 outbreak.
The Company maintains a full valuation allowance on its U.S.
net deferred tax assets.
−Removed: Deferred tax asset remeasurement (tax expense)
−Removed: was offset by a net decrease in valuation allowance, that resulted in no impact on the Company's income tax expense.
−Removed: the Company does not expect the provisions in the CARES Act will impact the Company’s Condensed Consolidated Financial Statements.
+Added: Deferred tax asset remeasurement (tax expense) was
+Added: offset by a net decrease in valuation allowance, that resulted in no impact on the Company's income tax expense.
+Added: Therefore, the Company
+Added: does not expect the provisions in the CARES Act will impact the Company’s consolidated financial statements.
+Added: On March 11, 2021, Congress enacted the American
+Added: Rescue Plan Act of 2021.
+Added: The Company does not expect the provisions of this act will impact the Company’s consolidated financial
Research and Development
−Removed: Research and development (“R&D”)
+Added: Research and Development (“R&D”)
expenses consist of costs incurred for direct and overhead-related research expenses and are expensed as incurred.
−Removed: Costs to acquire
−Removed: technologies, including licenses, that are utilized in R&D and that have no alternative future use are expensed when incurred.
−Removed: Technology developed for use in the Company’s product candidates is expensed as incurred until technological feasibility
−Removed: has been established.
−Removed: R&D expenses for the three and nine
−Removed: months ended January 31, 2021 were $174,088 and $595,976, respectively, and for the three and nine months ended January 31, 2020
−Removed: were $113,296 and $203,566, respectively.
+Added: Costs to acquire technologies,
+Added: including licenses, that are utilized in research and development and that have no alternative future use are expensed when incurred.
+Added: Technology developed for use in the Company’s product candidates is expensed as incurred until technological feasibility has been
+Added: R&D expenses for the three months ended
+Added: July 31, 2021 and 2020 were $ 143,613 and $ 270,574 , respectively.
Stock-Based Compensation
1 unchanged sentence
expense for only those awards ultimately expected to vest on a straight-line basis over the requisite service period of the award.
−Removed: The Company estimates the fair value of stock options using a Black-Scholes-Merton valuation model.
−Removed: This model requires the input
−Removed: of highly subjective assumptions, including the option's expected term and stock price volatility.
−Removed: In addition, judgment is also
−Removed: required in estimating the number of stock-based awards that are expected to be forfeited.
−Removed: Forfeitures are estimated based on historical
−Removed: experience at the time of grant and revised, if necessary, in subsequent periods if actual forfeitures differ from those estimates.
−Removed: The assumptions used in calculating the fair value of share-based payment awards represent management's best estimates, but these
−Removed: estimates involve inherent uncertainties and the application of management's judgment.
−Removed: Thus, if factors change and the Company
−Removed: uses different assumptions, the stock-based compensation expense could be materially different in the future.
+Added: Company estimates the fair value of stock options using a Black-Scholes-Merton valuation model.
+Added: This model requires the input of highly
+Added: subjective assumptions, including the option's expected term and stock price volatility.
+Added: In addition, judgment is also required in estimating
+Added: the number of stock-based awards that are expected to be forfeited.
+Added: Forfeitures are estimated based on historical experience at the time
+Added: of grant and revised, if necessary, in subsequent periods if actual forfeitures differ from those estimates.
+Added: The assumptions used in calculating
+Added: the fair value of share-based payment awards represent management's best estimates, but these estimates involve inherent uncertainties
+Added: and the application of management's judgment.
+Added: Thus, if factors change and the Company uses different assumptions, the stock-based compensation
+Added: expense could be materially different in the future.
Concentration of Credit Risk
1 unchanged sentence
concentrations of credit risk such as foreign exchange contracts, options contracts or other foreign hedging arrangements.
−Removed: Company maintains most of its cash balance at a financial institution located in California.
−Removed: Accounts at this institution are insured
−Removed: by the Federal Deposit Insurance Corporation up to $250,000.
−Removed: Uninsured balances aggregated approximately $2,810,000 and $618,000
−Removed: at January 31, 2021 and April 30, 2020, respectively.
+Added: maintains most of its cash balance at a financial institution located in California.
+Added: Accounts at this institution are insured by the Federal
+Added: Deposit Insurance Corporation up to $250,000.
+Added: Uninsured balances aggregated approximately $ 679,000 at July 31, 2021 and $ 1,921,000 at
+Added: April 30, 2021.
The Company has not experienced any losses in such accounts.
−Removed: Management believes
−Removed: it is not exposed to any significant credit risk on cash.
+Added: Management believes it is not exposed to any significant
+Added: credit risk on cash.
+Added: See Note 13 – Subsequent Events.
Foreign Currency Translation
−Removed: The Company translates the financial
−Removed: statements of its foreign subsidiaries from the local (functional) currencies to U.S.
−Removed: dollars in accordance with FASB ASC
−Removed: 830, Foreign Currency Matters .
−Removed: All assets and liabilities of the Company’s foreign subsidiaries are translated
−Removed: at period-end exchange rates, while revenue and expenses are translated at average exchange rates prevailing during the
−Removed: Adjustments for foreign currency translation fluctuations are excluded from net loss and are included in other
−Removed: comprehensive income (loss).
−Removed: Gains and losses on short-term intercompany foreign currency transactions are recognized as
−Removed: Going Concern
−Removed: The accompanying Condensed Consolidated
−Removed: Financial Statements have been prepared assuming that the Company will continue as a going concern;
−Removed: however, the following conditions
−Removed: raise substantial doubt about the Company's ability to do so.
−Removed: As of January 31, 2021, the Company has an accumulated deficit
−Removed: of $106,449,491 and incurred a net loss for the nine months ended January 31, 2021 of $2,591,232.
−Removed: The Company requires substantial
−Removed: additional capital to finance its planned business operations and expects to incur operating losses in future periods due to the
−Removed: expenses related to the Company’s core businesses.
−Removed: The Company has not realized any revenue since it commenced doing business
−Removed: in the biotechnology sector, and there can be no assurance that it will be successful in generating revenues in the future in this
−Removed: The Condensed Consolidated Financial Statements do not include any adjustments to reflect the possible future effects on
−Removed: the recoverability and classification of assets or the amounts and classifications of liabilities that may result should the Company
−Removed: be unable to continue as a going concern.
−Removed: For the nine months ended January 31, 2021,
−Removed: funding was provided by investors to maintain and expand the Company’s operations.
−Removed: Sales of the Company’s common stock
−Removed: were made under a Form S-3 (“S-3”) allowing for offerings of up to $50 million dollars.
−Removed: During the nine months ended
−Removed: January 31, 2021, the Company raised funds through the Company’s S-3 pursuant to which the placement agent sells shares of
−Removed: common stock “at-the-market”
−Removed: as defined in Rule 415 under the Securities Act of 1933, as amended (“Securities
−Removed: Act”), or in transactions of a distinct block or blocks of shares of the Company’s common stock (“Block Trade
−Removed: Transactions”) in a program which is structured to provide up to $25 million to the Company less certain commissions pursuant
−Removed: On August 13, 2020, the Company no longer
−Removed: 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
−Removed: From May 1, 2020 through August 13, 2020 the Company raised capital of approximately $4.7 million in Block Trade Transactions
−Removed: and “at-the-market”
−Removed: transactions.
−Removed: Management determined that its plans to
−Removed: raise additional capital alleviate substantial doubt about the Company’s ability to continue as a going concern.
−Removed: believes the cash on hand, the potential sales of unregistered shares of its common stock and any public offerings of common stock
−Removed: in which the Company may engage in will provide sufficient capital to meet the Company’s capital requirements and to fund
−Removed: the Company’s operations through March 31, 2022.
+Added: The Company translates the financial statements
+Added: of its foreign subsidiaries from the local (functional) currencies to U.S.
+Added: dollars in accordance with FASB ASC 830, Foreign Currency
+Added: All assets and liabilities of the Company’s foreign subsidiaries are translated at year-end exchange rates, while revenue
+Added: and expenses are translated at average exchange rates prevailing during the year.
+Added: Adjustments for foreign currency translation fluctuations
+Added: are excluded from net loss and are included in other comprehensive income (loss).
+Added: Gains and losses on short-term intercompany foreign
+Added: currency transactions are recognized as incurred.
+Added: As of July 31, 2021, the Company has an
+Added: accumulated deficit of $ 108,434,913
+Added: and incurred a net loss for the period ended July 31, 2021 of $ 1,025,418 .
+Added: The Company requires substantial additional capital to finance its planned business operations and expects to incur operating losses
+Added: in future periods due to the expenses related to the Company’s core businesses.
+Added: The Company has not realized any revenue since
+Added: it commenced doing business in the biotechnology sector, and there can be no assurance that it will be successful in generating
+Added: revenues in the future in this sector.
+Added: The Company has spent and expects to continue to spend, a substantial amount of funds in
+Added: connection with implementing its business strategy.
+Added: On August 9, 2021, the Company entered into an
+Added: underwriting agreement to offer and sell shares of common stock, pre-funded warrants to purchase common stock and warrants to purchase
+Added: common stock in a public offering (“First Offering”).
+Added: The gross proceeds of the First Offering were $ 15 million, before deduction
+Added: of underwriting discounts, commissions and estimated offering expenses.
+Added: See Note 13- Subsequent Events.
+Added: On August 19, 2021, the Company entered into a
+Added: securities purchase agreement (“Purchase Agreement”) with certain institutional investors (“Purchasers”) pursuant
+Added: to which the Company agreed to sell in a registered direct offering (“Registered Direct Offering”), shares of the Company’s
+Added: common stock and pre-funded warrants to purchase shares of common stock.
+Added: Further, pursuant to the Purchase Agreement, in a concurrent
+Added: private placement (together with the Registered Direct Offering, “Second Offering”), the Company also agreed to issue to the
+Added: Purchasers unregistered warrants (“Series A Warrants”) to purchase shares of common stock.
+Added: The Company received gross proceeds
+Added: from the Second Offering, before deducting placement agent fees and other estimated offering expenses payable by the Company, of approximately
+Added: $ 70 million.
+Added: See Note 13- Subsequent Events.
+Added: The Company believes the cash on hand at July
+Added: 31, 2021 and the proceeds from the First and Second offerings and warrant exercises provide sufficient capital to meet the Company’s
+Added: capital requirements through at least one year from the issuance date of these condensed consolidated financial statements.
+Added: As of September 13, 2021, the Company had cash
+Added: on hand of approximately $ 88 million.
Recent Accounting Pronouncements
−Removed: 2016-13, Financial Instruments
−Removed: - Credit Losses (Topic 326):
−Removed: Measurement of Credit Losses on Financial Instruments ("ASU 2016-13"), was issued in
−Removed: Under ASU 2016-13, existing guidance on reporting credit losses for trade and other receivables and available for sale
−Removed: debt securities will be replaced with a new forward-looking "expected loss"
−Removed: model that generally will result in the earlier
−Removed: recognition of allowances for losses.
−Removed: The Company’s adoption of ASU 2016-13 during the quarter ended July 31, 2020 did not
−Removed: result in an impact on the Company’s Condensed Consolidated Financial Statements.
−Removed: As part of the Company’s continuing
−Removed: assessment of the adequacy of AU 2016-13, there are no factors to be considered at this time since the Company does not have an
−Removed: allowance for credit losses.
+Added: 2016-13, Financial Instruments - Credit
+Added: Losses (Topic 326):
+Added: Measurement of Credit Losses on Financial Instruments (“ASU 2016-13”), was issued in June 2016.
+Added: ASU 2016-13, existing guidance on reporting credit losses for trade and other receivables and available for sale debt securities will
+Added: be replaced with a new forward-looking “expected loss” model that generally will result in the earlier recognition of allowances
+Added: 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
+Added: condensed consolidated financial statements.
+Added: As part of the Company’s continuing assessment of the adequacy of ASU 2016-13, there
+Added: are no factors to be considered at this time since the Company does not have an allowance for credit losses.
2019-12, Simplifying the Accounting
−Removed: for Income Taxes ("ASU 2019-12"), was issued in December 2019.
−Removed: Under ASU 2019-12, the accounting for income taxes
−Removed: is simplified by eliminating certain exceptions and implementing additional requirements which result in a more consistent application
−Removed: The Company is currently in the process of evaluating the impact of adopting ASU 2019-12 in 2021, but it does not expect
−Removed: it to have a material impact on the Company’s Condensed Consolidated Financial Statements.
−Removed: NOTE 3 –
+Added: for Income Taxes (“ASU 2019-12”), was issued in December 2019.
+Added: Under ASU 2019-12, the accounting for income taxes is simplified
+Added: by eliminating certain exceptions and implementing additional requirements which result in a more consistent application of ASC 740.
+Added: Company’s adoption of ASU 2019-12 during the quarter ended July 31, 2021 did not result in an impact on the Company’s condensed
+Added: consolidated financial statements.
+Added: In March 2020, the FASB issued ASU 2020-04, Reference
+Added: Rate Reform (Topic 848):
+Added: Facilitation of the Effects of Reference Rate Reform on Financial Reporting (“ASU 2020-04”) and also
+Added: issued subsequent amendments to the initial guidance (collectively, “Topic 848”).
+Added: Topic 848 is effective for all entities
+Added: as of March 12, 2020 through December 31, 2022 and provides optional guidance for contract modifications and certain hedging relationships
+Added: associated with the transition from reference rates that are expected to be discontinued.
+Added: The Company will adopt Topic 848 when relevant
+Added: contracts are modified upon transition to alternative reference rates.
+Added: The Company does not expect the adoption of Topic 848 to have a
+Added: material impact on the Company’s condensed consolidated financial statements.
+Added: NOTE 3 – ACCRUED EXPENSES
+Added: Accrued expenses at July 31, 2021 and April 30,
+Added: 2021 are summarized below:
Accrued expenses
−Removed: Accrued expenses at January 31, 2021 and
−Removed: April 30, 2020 are summarized below:
−Removed: January 31, 2021
+Added: July 31, 2021
April 30, 2021
Payroll related costs
−Removed: Director and Officer insurance financing
+Added: Director and Officer insurance
The Company financed the Director and Officer
insurance policy.
−Removed: The term of the policy is from March 8, 2020 through March 8, 2021.
+Added: The term of the policy is from March 8, 2021 through September 8, 2021 .
The financing agreement has an interest rate
−Removed: of 4.25% per annum and requires ten monthly payments of $12,806.
−Removed: The unpaid balances as of January 31, 2021 and April 30, 2020
−Removed: are $0 and $113,245, respectively, which are included in accrued expenses.
−Removed: NOTE 4 –
−Removed: SMALL BUSINESS ADMINISTRATION
+Added: of 4.85 % per annum and requires eight monthly payments of $ 12,829 .
+Added: The unpaid balances as of July 31, 2021 and April 30, 2021 of $ 12,786
+Added: and $ 50,805 , respectively, are included in accrued expenses.
+Added: NOTE 4 – SMALL BUSINESS ADMINISTRATION
– PAYCHECK PROTECTION PROGRAM
−Removed: On March 27, 2020, the CARES Act was enacted
−Removed: to provide financial aid to family and businesses impacted by COVID-19.
−Removed: The Company participated in the CARES Act, and on
−Removed: April 15, 2020, the Company entered into a note payable with a bank under the Small Business Administration (“SBA”)
−Removed: Paycheck Protection Program (“PPP”) loan in the amount of $75,200.
−Removed: This loan payable matures on April 15, 2022 with
−Removed: a fixed interest rate of 1% per annum with interest deferred for six months.
−Removed: The PPP loan has an initial term of two years, is
−Removed: unsecured and guaranteed by the SBA.
−Removed: Under the terms of the PPP loan, the Company may apply for forgiveness of the amount due on
−Removed: the PPP loan.
−Removed: The Company used the proceeds from the PPP loan for qualifying expenses as defined in the PPP.
−Removed: The Company intends
−Removed: to apply for forgiveness of the PPP loan in accordance with the terms of the CARES Act.
−Removed: However, the Company cannot assure at this
−Removed: time that the PPP loan will be forgiven partially or in full.
−Removed: The outstanding PPP loan balance as of January 31, 2021 and April
−Removed: 30, 2020 was $75,200.
−Removed: NOTE 5 –
−Removed: COMMON STOCK TRANSACTIONS
−Removed: A summary of the Company’s stock
−Removed: activity and related weighted average grant date fair value information for the nine months ended January 31, 2021 and 2020 is
−Removed: During the nine months ended January 31,
−Removed: 2020, the Company issued 2,000,000 shares of common stock to four non-employee members of the Company’s Board of Directors
−Removed: (“Board”) pursuant to Director Letter Agreements (“DLAs”) with the Company for services relating to the
−Removed: The shares vested upon issuance and the Company recorded a non-cash expense of $0 and $0 and for the three and nine
−Removed: months ended January 31, 2021, respectively, and $0 and $19,212 for the three and nine months ended January 31, 2020, respectively.
−Removed: There were zero unvested shares as of January 31, 2021.
−Removed: Effective July 1, 2018, the Company issued
−Removed: 1,200,000 shares of common stock to a consultant.
−Removed: The term of the agreement is for twelve months.
−Removed: The shares vest monthly over
−Removed: a twelve-month period and are subject to the consultant providing services under the agreement.
−Removed: The Company recorded a non-cash
−Removed: consulting expense in the amount of $0 and $0 for the three and nine months ended January 31, 2021, respectively, and $0 and $12,816
−Removed: for the three and nine months ended January 31, 2020, respectively.
−Removed: There were zero unvested shares as of January 31, 2021 and
−Removed: During the month of April 2019, two consultants
−Removed: were issued 2,500,000 shares of common stock pursuant to their consulting agreements.
−Removed: The term of the agreements is for twelve
−Removed: months which covered prior and current periods.
−Removed: The shares vest monthly over a twelve-month period and are subject to the consultants
−Removed: providing services under their respective consulting agreements.
−Removed: The Company recorded a non-cash consulting expense in the amount
−Removed: of $0 and $0 for the three and nine months ended January 31, 2021, respectively, and $0 and $11,910 for the three and nine months
−Removed: ended January 31, 2020, respectively.
−Removed: There were zero unvested shares as of January 31, 2021 and 2020.
−Removed: During the nine months ended January 31,
−Removed: 2020, a consultant was issued 500,000 shares of common stock pursuant to his consulting agreement with the Company.
−Removed: the consulting agreement is for twelve months which covered prior and current periods.
−Removed: The shares vest monthly over a twelve-month
−Removed: period and are subject to the consultant providing services under his consulting agreement.
−Removed: The Company recorded a non-cash consulting
−Removed: expense in the amount of $0 and $0 for the three and nine months ended January 31, 2021, respectively, and $0 and $17,350 for the
−Removed: three and nine months ended January 31, 2020, respectively.
−Removed: There were zero unvested shares as of January 31, 2021 and 2020.
−Removed: In January 2019, the Company awarded 6,600,000
−Removed: shares of common stock to executive officers of the Company as part of their compensation agreements for 2019.
−Removed: These shares vest
−Removed: monthly over a twelve-month period and are subject to the executive officers continuing to provide service under their compensation
−Removed: During the three and nine months ended January 31, 2021, the Company recorded a non-cash compensation expense in the
−Removed: amount of $0 and $0, respectively, and $69,438 and $278,891 for the three and nine months ended January 31, 2020, respectively.
−Removed: There were zero unvested shares as of January 31, 2021 and 2020.
−Removed: During the nine months ended January 31,
−Removed: 2020, four non-employee members of the Board were issued 2,000,000 shares of common stock pursuant to their DLAs with the Company.
−Removed: The shares were fully vested upon issuance.
−Removed: The Company recorded a non-cash expense of $0 and $10,561 for the three and nine months
−Removed: ended January 31, 2021, respectively, and $18,988 and $46,433 for the three and nine months ended January 31, 2020, respectively.
−Removed: There were zero unvested shares remaining related to these DLAs as of January 31, 2021 and 2020.
−Removed: During the nine months ended January 31,
−Removed: 2020, a consultant was issued 2,000,000 shares of common stock in respect of his services as the Chairman of the Company’s
−Removed: Medical and Scientific Advisory Board over a four-year period with their vesting subject to the consultant continuing to provide
−Removed: services to the Company.
−Removed: The Company recorded a non-cash consulting expense in the amount of $0 and $0 for the three and nine months
−Removed: ended January 31, 2021, respectively, and $0 and $11,851 for the three and nine months ended January 31, 2020, respectively.
−Removed: were zero unvested shares remaining related to his compensation arrangement as of January 31, 2021 and 2020.
−Removed: During the nine months ended January 31,
−Removed: 2021, four non-employee members of the Board were issued 2,000,000 shares of common stock pursuant to their DLAs in respect of
−Removed: their service during that year.
+Added: On March 27, 2020, the Coronavirus Aid, Relief,
+Added: and Economic Security Act (the “CARES Act”) was enacted to provide financial aid to family and businesses impacted by the
+Added: COVID-19 pandemic.
+Added: The Company participated in the CARES Act, and on April 15, 2020, the Company entered into a note payable with
+Added: a bank under the Small Business Administration (“SBA”), Paycheck Protection Program (“PPP”) in the amount of $ 75,200 .
+Added: This PPP loan matured on April 15, 2022 with a fixed interest rate of 1 % per annum with interest deferred for six months.
+Added: had an initial term of two years, was unsecured and guaranteed by the SBA.
+Added: Under the terms of the PPP loan, the Company may apply for
+Added: forgiveness of the amount due on the PPP loan.
+Added: The Company used the proceeds from the PPP loan for qualifying expenses as defined in the
+Added: The Company applied for forgiveness of the PPP loan in accordance with the terms of the CARES Act.
+Added: The SBA issued a notice of PPP
+Added: loan forgiveness with an effective date of April 28, 2021, forgiving the entire principal of $ 75,200 and the accrued interest of $ 779 .
+Added: The Company recognized the forgiveness of the PPP loan and accrued interest as Gain on forgiveness of Paycheck Protection Program loan
+Added: in the fiscal year ended April 30, 2021.
+Added: NOTE 5 – COMMON STOCK TRANSACTIONS
+Added: A summary of the Company’s
+Added: compensatory stock activity and related weighted average grant date fair value information for the three months ended July 31, 2021
+Added: and 2020 is as follows:
+Added: During the year ended April 30, 2020, four
+Added: non-employee members of the Board were issued 1,333 shares of common stock pursuant to their respective Director Letter Agreement
+Added: (“DLAs”) and relating to their services for the prior year.
The shares were fully vested upon issuance.
−Removed: The Company recorded a non-cash expense of $10,411
−Removed: and $26,859 for the three and nine months ended January 31, 2021, respectively.
−Removed: There were zero unvested shares remaining related
−Removed: to such DLAs as of January 31, 2021.
−Removed: During the nine months ended January 31,
−Removed: 2021 four consultants were issued 1,000,000 shares of common stock pursuant to their consulting agreements with the Company.
−Removed: terms of the agreements are for twelve months.
−Removed: The shares vest monthly over a twelve-month period and are subject to the consultants
−Removed: continuing to provide services under their consulting agreements.
−Removed: The Company recorded a non-cash consulting expense in the amount
−Removed: of $5,409 and $15,017 for the three and nine months ended January 31, 2021, respectively.
−Removed: There were 250,000 unvested shares remaining
−Removed: related to these consulting agreements as of January 31, 2021.
+Added: recorded a non-cash expense of $ 0 and $ 7,356 for the three months ended July 31, 2021 and 2020, respectively.
+Added: There were zero
+Added: 0 unvested shares of common stock remaining related to these DLAs as of July 31, 2021 and 2020, respectively.
In January 2020, the Company awarded 4,400
shares of common stock to the executive officers of the Company as part of their compensation agreements for 2020.
−Removed: vest monthly over a twelve-month period and are subject to the executive officers continuing to provide service under their compensation
−Removed: During the three and nine months ended January 31, 2021, the Company recorded a non-cash compensation expense in the
−Removed: amounts of $44,881 and $179,521, respectively, and $30,800 and $30,800 for the three and nine months ended January 31, 2020, respectively.
−Removed: There were zero and 6,050,000 unvested shares as of January 31, 2021 and 2020, respectively.
−Removed: During the nine months ended January 31,
−Removed: 2021, a consultant was issued 500,000 shares of common stock in respect of his services as the Chairman of the Company’s
−Removed: Medical and Scientific Advisory Board with vesting subject to the consultant continuing to provide services to the Company.
−Removed: Company recorded a non-cash consulting expense in the amount of $2,125 and $2,833 for the three and nine months ended January 31,
−Removed: 2021, respectively, and $0 and $0 for the three and nine months ended January 31, 2020, respectively.
−Removed: There were zero unvested
−Removed: shares remaining related to his compensation arrangement as of January 31, 2021 and 2020, respectively.
+Added: These shares vest
+Added: monthly over a twelve-month period and are subject to them continuing service under the agreements.
+Added: During the three months ended
+Added: July 31, 2021 and 2020, the Company recorded a non-cash compensation expense in the amount of $ 0 and $ 67,320 , respectively.
+Added: were zero 0 and 1,833 unvested shares as of July 31, 2021 and 2020, respectively.
+Added: three months ended July 31, 2020, three non-employee members of the Board were issued 1,000
+Added: shares of common stock pursuant to their DLAs in respect of their service during that year.
+Added: The shares were fully vested upon
+Added: The Company recorded a non-cash expense of $ 3,371
+Added: for the three months ended July 31, 2021 and 2020, respectively.
+Added: There were zero 0 unvested shares remaining related to such DLAs as
+Added: of July 31, 2021.
+Added: During the three months ended July 31, 2020,
+Added: four consultants were issued 667
+Added: shares of common stock pursuant to their consulting agreements with the Company.
+Added: The shares vest monthly over a twelve-month period
+Added: and are subject to the consultants continuing to provide services under their consulting agreements.
+Added: The Company recorded a non-cash
+Added: consulting expense in the amount of $ 0
+Added: for the three months ended July 31, 2021 and 2020, respectively.
+Added: There were zero 0 and 500 unvested shares remaining related to
+Added: these consulting agreements as of July 31, 2021 and 2020, respectively.
+Added: In September 2020, a consultant was issued 333 shares
+Added: of common stock in respect of his services as the Chairman of the Company’s Medical and Scientific Advisory Board with vesting
+Added: subject to the consultant continuing to provide services to the Company.
+Added: The Company recorded a non-cash consulting expense in the
+Added: amount of $ 2,125
+Added: for the three months ended July 31, 2021 and 2020, respectively.
+Added: There were zero 0 unvested shares remaining related to his
+Added: compensation arrangement as of July 31, 2021.
In January 2021, the Company awarded 4,400
shares of common stock to the executive officers of the Company as part of their compensation agreements for 2021.
−Removed: vest monthly over a twelve-month period and are subject to the executive officers continuing to provide service under their compensation
−Removed: During the three and nine months ended January 31, 2021, the Company recorded a non-cash compensation expense in the
−Removed: amounts of $3,685 and $3,685, respectively.
−Removed: There were 6,050,000 unvested shares as of January 31, 2021.
−Removed: All shares listed above were issued without
−Removed: registration under the Securities Act in reliance upon the exemption afforded by Section 4(a)(2) of the Securities Act.
−Removed: During the nine months ended January 31,
−Removed: 2021 and 2020, the Company sold and issued approximately 693 million and 137 million shares of common stock, respectively, at prices
−Removed: of approximately $0.01 per share pursuant to the Company’s S-3.
−Removed: Net of underwriting discounts, legal, accounting and other
−Removed: offering expenses, the Company received net proceeds of approximately $4.7 million and $884,000 from the sale of these shares for
−Removed: the nine months ended January 31, 2021 and 2020, respectively.
−Removed: A summary of the Company’s unvested
−Removed: restricted stock activity and related weighted average grant date fair value information for the nine months ended January 31,
−Removed: 2021 is as follows:
+Added: These shares vest
+Added: monthly over a twelve-month period and are subject to the executive officers continuing to provide service under their compensation
+Added: During the three months ended July 31, 2021, the Company recorded a non-cash compensation expense in the amount of
+Added: There were 1,833 unvested shares as of July 31, 2021.
+Added: During the three months ended July 31, 2021,
+Added: three non-employee members of the Board were issued 1,002 shares of common stock pursuant to their DLAs in respect of their service
+Added: during that year.
+Added: The shares were fully vested upon issuance.
+Added: The Company recorded a non-cash expense of $ 4,885 for the three months
+Added: ended July 31, 2021.
+Added: There were zero 0 unvested shares remaining related to such DLAs as of July 31, 2021.
+Added: During the three months ended July 31, 2021,
+Added: two consultants were issued 334 shares of common stock pursuant to their consulting agreements with the Company.
+Added: The shares vest
+Added: monthly over a twelve-month period and are subject to the consultants continuing to provide services under their consulting
+Added: The Company recorded a non-cash consulting expense in the amount of $ 1,620 for the three months ended July 31, 2021.
+Added: There were 251 unvested shares remaining related to these consulting agreements as of July 31, 2021.
+Added: All shares were issued without registration under
+Added: the Securities Act in reliance upon the exemption afforded by Section 4(a)(2) of the Securities Act.
+Added: On September 28, 2017, a S-3 registration
+Added: statement was declared effective by the Commission for the Company to sell from time to time in one or more public offerings of up
+Added: to $50 million of its securities on a “shelf offering” basis.
+Added: During the three months ended July 31, 2021 and 2020, the
+Added: Company sold and issued approximately 0
+Added: and 156,000 shares
+Added: of common stock, respectively, at prices ranging from approximately $15 to $45 per share.
+Added: Net of underwriting discounts, legal,
+Added: accounting and other offering expenses, the Company received proceeds of approximately $ 0
+Added: million from the sale of these shares for the three months ended July 31, 2021 and 2020, respectively.
+Added: On April 9, 2021, the Third
+Added: S-3 (“Third S-3”) was declared effective by the Commission for a public offering of up to $100 million on a “shelf
+Added: offering” basis.
+Added: A summary of the Company’s non-vested restricted
+Added: stock activity and related weighted average grant date fair value information for the three months ended July 31, 2021 are as follows:
+Added: Schedule of non-vested restricted stock activity
Unvested, at April 30, 2021
−Removed: Unvested, at January 31, 2021
−Removed: NOTE 6 –
−Removed: STOCK OPTIONS AND WARRANTS
+Added: Unvested, at July 31, 2021
+Added: NOTE 6 – STOCK OPTIONS AND WARRANTS
Stock Options
−Removed: As of January 31, 2021, the Company had
−Removed: 62,600,000 outstanding stock options to its directors and executive officers (collectively, “Employee Options”) and
−Removed: consultants (“Non-Employee Options”).
−Removed: During the nine months ended January 31,
+Added: As of July 31, 2021, the Company had 42,333 outstanding
+Added: stock options to its directors and officers (collectively, “Employee Options”) and consultants (“Non-Employee Options”).
+Added: During the three months ended July 31, 2021
and 2020, the Company granted 1,000 and 1,000 Employee Options, respectively.
−Removed: The fair value of the Employee Options
−Removed: at the date of grant was estimated using the Black-Scholes-Merton option-pricing model, based on the following weighted average
−Removed: Nine Months Ended January 31,
+Added: The fair value of the Employee Options at the
+Added: date of grant was estimated using the Black-Scholes-Merton option-pricing model, based on the following weighted average assumptions:
+Added: Three Months Ended July 31,
Risk-free interest rate
Expected volatility
−Removed: Expected term (years)
+Added: Expected lives (years)
Expected dividend yield
−Removed: The Company’s computation of expected
+Added: The Company’s computation of expected
volatility is based on the historical daily volatility of its publicly traded stock.
−Removed: For stock option grants issued during the
−Removed: nine months ended January 31, 2021 and 2020, the Company used a calculated volatility for each grant.
−Removed: The Company lacks adequate
−Removed: information about the exercise behavior and therefore has determined the expected term assumption under the simplified method provided
−Removed: for under ASC 718, which averages the contractual term of the Company’s stock options of five years with the average vesting
−Removed: term of two and seven-tenths years for an average of 2.7 years.
−Removed: The dividend yield assumption of zero is based upon the fact the
−Removed: Company has never paid cash dividends and presently has no intention of paying cash dividends.
−Removed: The risk-free interest rate used
−Removed: for each grant is equal to the U.S.
+Added: For stock option grants issued during the three
+Added: months ended July 31, 2021 and 2020, the Company used a calculated volatility for each grant.
+Added: The Company lacks adequate information
+Added: about the exercise behavior now and has determined the expected term assumption under the simplified method provided for under ASC
+Added: 718, which averages the contractual term of the Company’s stock options of five years with the average vesting term of two and
+Added: one-half years for an average of three years.
+Added: The dividend yield assumption of zero is based upon the fact the Company has never
+Added: paid cash dividends and presently has no intention of paying cash dividends.
+Added: The risk-free interest rate used for each grant is
+Added: equal to the U.S.
Treasury rates in effect at the time of the grant for instruments with a similar expected life.
−Removed: During the nine months ended January 31,
−Removed: 2021 and 2020, the Company granted zero and 1,200,000 Non-Employee Options, respectively.
−Removed: During the three months ended January
−Removed: 31, 2021 and 2020, the Company granted zero and zero Non-Employee Options, respectively.
−Removed: A summary of the Company’s stock
−Removed: option activity and related information for the nine months ended January 31, 2021 is shown below:
−Removed: Exercise Price per Share
+Added: During the three months ended July 31, 2021
+Added: and 2020, the Company granted no Non-Employee Options.
+Added: A summary of the Company’s stock option
+Added: activity and related information for the three months ended July 31, 2021 are shown below:
+Added: Stock option activity
+Added: Exercise Price
Outstanding, April 30, 2021
−Removed: (15,600,000 )
−Removed: Outstanding, January 31, 2021
−Removed: Exercisable, January 31, 2021
+Added: Outstanding, July 31, 2021
+Added: Exercisable, July 31, 2021
Vested and expected to vest
−Removed: A summary of the activity for unvested
−Removed: stock options during the nine months ended January 31, 2021 is as follows:
+Added: A summary of the activity for unvested stock
+Added: options during the years ended April 30, 2021 and 2020 is as follows:
+Added: Unvested stock option activity
Unvested, April 30, 2021
−Removed: Unvested, January 31, 2021
−Removed: The Company recorded $38,606 and $74,025
−Removed: of stock-based compensation expense related to the issuance of Employee Options to certain executive officers and directors in
−Removed: exchange for services during the three months ended January 31, 2021 and 2020, respectively, and $166,982 and $284,934 during the
−Removed: nine months ended January 31, 2021 and 2020, respectively.
−Removed: At January 31, 2021, there remained $35,148 of unrecognized compensation
−Removed: expense related to unvested Employee Options granted to executive officers and directors, to be recognized as expense over a weighted-average
−Removed: period of the remaining eleven months in the calendar year.
−Removed: The unvested options vest at 750,000 shares per month and are expected
−Removed: to be fully vested on December 31, 2021.
+Added: Unvested, July 31, 2021
The Company recorded $ 24,144 and $ 72,317 of
−Removed: stock-based compensation related to the issuance of Non-Employee Options in exchange for services during the three months ended
−Removed: January 31, 2021 and 2020, respectively, and $0 and $24,237 during the nine months ended January 31, 2021 and 2020, respectively.
−Removed: There were no unvested Non-Employee Options on January 31, 2021.
+Added: stock-based compensation related to the issuance of Employee Options to certain officers and directors in exchange for services
+Added: during the three months ended July 31, 2021 and 2020, respectively.
+Added: At July 31, 2021, there remained $ 15,976 of unrecognized
+Added: compensation expense related to unvested Employee Options granted to officers and directors, to be recognized as expense over a
+Added: weighted-average period of the remaining five months in the calendar year.
+Added: The unvested options vest at 500 shares per month and
+Added: are expected to be fully vested on December 31, 2021.
+Added: The Company recorded no stock-based
+Added: compensation related to the issuance of Non-Employee Options in exchange for services during the three months ended July 31, 2021
+Added: and 2020, respectively.
The following table summarizes the outstanding
−Removed: stock options by exercise price at January 31, 2021:
+Added: stock options by exercise price at July 31, 2021:
+Added: Schedule of options by exercise price
Exercise Price
Contractual Life
−Removed: of Outstanding
−Removed: Options (years)
+Added: Price Per Share
Weighted Average
1 unchanged sentence
of Exercisable
−Removed: The aggregate intrinsic value of outstanding
−Removed: options as of January 31, 2021 was $12,225.
−Removed: This represents options whose exercise price was less than the closing fair market
−Removed: value of the Company’s common stock on January 31, 2021 of approximately $0.018 per share.
−Removed: The warrants issued by the Company are
−Removed: equity-classified.
+Added: The aggregate intrinsic value of outstanding options
+Added: as of July 31, 2021 was $ 6,860 .
+Added: This represents options whose exercise price was less than the closing fair market value of the Company’s
+Added: common stock on July 31, 2021 of approximately $ 12.01 per share.
+Added: The warrants issued by the Company are equity-classified.
The fair value of the warrants was recorded as additional paid-in-capital, and no further adjustments are made.
−Removed: For stock warrants paid in consideration
−Removed: of services rendered by non-employees, the Company recognizes consulting expense in accordance with the requirements of ASC 505.
−Removed: Common Stock Purchase Warrants issued in conjunction with Block Trade transactions to Aeon Capital, Inc.
−Removed: (“Aeon”),
−Removed: the Company’s placement agent under its S-3 “at-the-market”
−Removed: prospectus, are accounted for in accordance with
−Removed: ASC 815-40, with the fair value recorded to additional paid-in capital and offsetting amounts recorded as equity issuance costs
−Removed: on the Condensed Consolidated Statement of Stockholders’
−Removed: Effective June 13, 2019, the Company issued
−Removed: a Common Stock Purchase Warrant to Aeon for a Block Trade transaction.
−Removed: The Company issued a warrant to purchase 1,338,889 shares
−Removed: of common stock based upon the Block Trade transaction pursuant to the Company’s engagement agreement with Aeon dated February
−Removed: 22, 2018 (“Aeon Engagement Agreement”).
−Removed: The Company classified these warrants as equity.
−Removed: The warrants have a term of
−Removed: five years with an exercise price of approximately $0.01 per warrant share.
−Removed: Using the Black-Scholes-Merton option pricing model,
−Removed: the Company determined the aggregate fair value of these warrants to be approximately $9,000.
−Removed: The warrants have a cashless exercise
−Removed: Effective July 15, 2019, the Company issued
−Removed: a Common Stock Purchase Warrant to Aeon for a Block Trade transaction.
−Removed: The Company issued a warrant to purchase 1,944,444 shares
−Removed: of common stock based upon the Block Trade pursuant to the Aeon Engagement Agreement.
−Removed: The Company classified these warrants as
−Removed: The warrants have a term of five years with an exercise price of approximately $0.01 per warrant share.
−Removed: Using the Black-Scholes-Merton
−Removed: option pricing model, the Company determined the aggregate fair value of these warrants to be approximately $12,000.
−Removed: have a cashless exercise feature.
−Removed: Effective August 7, 2019, the Company issued
−Removed: two Common Stock Purchase Warrants to Aeon for two Block Trade transactions.
−Removed: The Company issued two warrants to purchase a total
−Removed: of 3,500,000 shares of common stock based on two Block Trades pursuant to the Aeon Engagement Agreement.
−Removed: The Company classified
−Removed: these warrants as equity.
−Removed: The warrants have a term of five years with an exercise price of approximately $0.01 per warrant share.
−Removed: Using the Black-Scholes-Merton option pricing model, the Company determined the aggregate value of these warrants to be approximately
−Removed: The warrants have a cashless exercise feature.
−Removed: Effective July 10, 2020, the Company issued
−Removed: a Common Stock Purchase Warrant to Aeon for a Block Trade transaction.
−Removed: The Company issued a warrant to purchase 4,100,000 shares
−Removed: of common stock based upon the Block Trade pursuant to the Aeon Engagement Agreement.
−Removed: The Company classified these warrants as
−Removed: The warrants have a term of five years with an exercise price of $0.01 per warrant share.
−Removed: Using the Black-Scholes-Merton
−Removed: option pricing model, the Company determined the aggregate fair value of these warrants to be approximately $29,000.
−Removed: have a cashless exercise feature.
−Removed: Effective July 18, 2020, the Company issued
−Removed: a Common Stock Purchase Warrant to Aeon for a Block Trade transaction.
−Removed: The Company issued a warrant to purchase 3,500,000 shares
−Removed: of common stock based upon the Block Trade pursuant to the Aeon Engagement Agreement.
−Removed: The Company classified these warrants as
−Removed: The warrants have a term of five years with an exercise price of approximately $0.01 per warrant share.
−Removed: Using the Black-Scholes-Merton
−Removed: option pricing model, the Company determined the aggregate fair value of these warrants to be approximately $18,000.
−Removed: have a cashless exercise feature.
−Removed: Effective July 19, 2020, the Company issued
−Removed: a Common Stock Purchase Warrant to Aeon for a Block Trade transaction.
−Removed: The Company issued a warrant to purchase 1,333,333 shares
−Removed: of common stock based upon the Block Trade pursuant to the Aeon Engagement Agreement.
−Removed: The Company classified these warrants as
−Removed: The warrants have a term of five years with an exercise price of approximately $0.01 per warrant share.
−Removed: Using the Black-Scholes-Merton
−Removed: option pricing model, the Company determined the aggregate fair value of these warrants to be approximately $7,000.
−Removed: have a cashless exercise feature.
−Removed: Effective July 27, 2020, the Company issued
−Removed: a Common Stock Purchase Warrant to Aeon for a Block Trade transaction.
−Removed: The Company issued a warrant to purchase 2,500,000 shares
−Removed: of common stock based upon the Block Trade pursuant to the Aeon Engagement Agreement.
−Removed: The Company classified these warrants as
−Removed: The warrants have a term of five years with an exercise price of approximately $0.01 per warrant share.
−Removed: Using the Black-Scholes-Merton
−Removed: option pricing model, the Company determined the aggregate fair value of these warrants to be approximately $13,000.
−Removed: have a cashless exercise feature.
−Removed: Effective August 3, 2020, the Company issued
−Removed: a Common Stock Purchase Warrant to Aeon for a Block Trade transaction.
−Removed: The Company issued a warrant to purchase 4,500,000 shares
−Removed: of common stock based upon the Block Trade pursuant to the Aeon Engagement Agreement.
−Removed: The Company classified these warrants as
−Removed: The warrants have a term of five years with an exercise price of approximately $0.01 per warrant share.
−Removed: Using the Black-Scholes-Merton
−Removed: option pricing model, the Company determined the aggregate fair value of these warrants to be approximately $24,000.
−Removed: have a cashless exercise feature.
−Removed: Effective August 6, 2020, the Company issued
−Removed: a Common Stock Purchase Warrant to Aeon for a Block Trade transaction.
−Removed: The Company issued a warrant to purchase 4,100,000 shares
−Removed: of common stock based upon the Block Trade pursuant to the Aeon Engagement Agreement.
−Removed: The Company classified these warrants as
−Removed: The warrants have a term of five years with an exercise price of $0.01 per warrant share.
−Removed: Using the Black-Scholes-Merton
−Removed: option pricing model, the Company determined the aggregate fair value of these warrants to be approximately $29,000.
−Removed: have a cashless exercise feature.
−Removed: Effective August 6, 2020, the Company issued
−Removed: a Common Stock Purchase Warrant to Aeon for a Block Trade transaction.
−Removed: The Company issued a warrant to purchase 5,000,000 shares
−Removed: of common stock based upon the Block Trade pursuant to the Aeon Engagement Agreement.
−Removed: The Company classified these warrants as
−Removed: The warrants have a term of five years with an exercise price of approximately $0.01 per warrant share.
−Removed: Using the Black-Scholes-Merton
−Removed: option pricing model, the Company determined the aggregate fair value of these warrants to be approximately $18,000.
−Removed: have a cashless exercise feature.
−Removed: Effective August 7, 2020, the Company issued
−Removed: a Common Stock Purchase Warrant to Aeon for a Block Trade transaction.
−Removed: The Company issued a warrant to purchase 2,500,000 shares
−Removed: of common stock based upon the Block Trade pursuant to the Aeon Engagement Agreement.
−Removed: The Company classified these warrants as
−Removed: The warrants have a term of five years with an exercise price of approximately $0.01 per warrant share.
−Removed: Using the Black-Scholes-Merton
−Removed: option pricing model, the Company determined the aggregate fair value of these warrants to be approximately $13,000.
−Removed: have a cashless exercise feature.
−Removed: Effective August 7, 2020, the Company issued
−Removed: a Common Stock Purchase Warrant to Aeon for a Block Trade transaction.
−Removed: The Company issued a warrant to purchase 5,500,000 shares
−Removed: of common stock based upon the Block Trade pursuant to the Aeon Engagement Agreement.
−Removed: The Company classified these warrants as
−Removed: The warrants have a term of five years with an exercise price of approximately $0.01 per warrant share.
−Removed: Using the Black-Scholes-Merton
−Removed: option pricing model, the Company determined the aggregate fair value of these warrants to be approximately $19,000.
−Removed: have a cashless exercise feature.
−Removed: Effective August 10, 2020, the Company
−Removed: issued a Common Stock Purchase Warrant to Aeon for a Block Trade transaction.
−Removed: The Company issued a warrant to purchase 1,333,333
−Removed: shares of common stock based upon the Block Trade pursuant to the Aeon Engagement Agreement.
−Removed: The Company classified these warrants
−Removed: The warrants have a term of five years with an exercise price of approximately $0.01 per warrant share.
−Removed: Using the Black-Scholes-Merton
−Removed: option pricing model, the Company determined the aggregate fair value of these warrants to be approximately $7,000.
−Removed: have a cashless exercise feature.
−Removed: A summary of the Company’s warrant
−Removed: activity and related information for the nine months ended January 31, 2021 is shown below:
+Added: For stock warrants paid in consideration of services
+Added: rendered by non-employees, the Company recognizes consulting expense in accordance with the requirements of ASC 505.
+Added: A summary of the Company’s warrant activity
+Added: and related information for the three months ended July 31, 2021 are shown below:
+Added: Warrant activity
Exercise Price
Outstanding, April 30, 2021
−Removed: (17,000,000 )
−Removed: Outstanding, January 31, 2021
−Removed: Exercisable, January 31, 2021
−Removed: The following table summarizes additional
−Removed: information concerning warrants outstanding and exercisable at January 31, 2021:
+Added: Outstanding, July 31, 2021
+Added: Exercisable, July 31, 2021
+Added: The following table summarizes additional information
+Added: concerning warrants outstanding and exercisable at July 31, 2021:
+Added: Schedule of warrants outstanding and exercisable
Exercise Prices
1 unchanged sentence
Exercisable at
−Removed: April 30, 2020
+Added: July 31, 2021
Exercise Price
−Removed: NOTE 7 –
−Removed: LEGAL PROCEEDINGS
−Removed: The Company is not currently a party to
−Removed: any pending legal proceedings, material or otherwise.
−Removed: There are no legal proceedings to which any property of the Company is subject.
−Removed: NOTE 8 –
−Removed: RELATED PARTY TRANSACTIONS
−Removed: The Company had the following related party
−Removed: transactions during the three and nine months ended January 31, 2021 and 2020.
−Removed: The Company owns 14.5% of the equity in
+Added: NOTE 7 – LEGAL PROCEEDINGS
+Added: There is no material litigation currently pending
+Added: against the Company or any of its subsidiaries or to which any of the subsidiaries’ property is subject.
+Added: To the Company’s
+Added: knowledge, there is no material litigation against any of its officers or directors in their capacity as such, and no such litigation
+Added: is contemplated by any governmental authorities.
+Added: NOTE 8 – RELATED PARTY TRANSACTIONS
+Added: The Company had the following related party transactions
+Added: during the three months ended July 31, 2021 and 2020, respectively.
+Added: The Company owns 14.5 % of the equity in SG
(“SG Austria”) and is reported on the cost method of accounting.
SG Austria has two subsidiaries:
−Removed: (i) Austrianova Singapore Pte.
−Removed: (“Austrianova”);
−Removed: and (ii) Austrianova Thailand Company Ltd.
−Removed: The Company purchased products and services from these
−Removed: subsidiaries in the approximate amounts of $109,500 and $183,500 in the three and nine months ended January 31, 2021, respectively,
−Removed: and $85,000 and $87,400 for the three and nine months ended January 31, 2020, respectively.
−Removed: In April 2014, the Company entered the
−Removed: Vin-de-Bona Consulting Agreement pursuant to which Vin-de-Bona agreed to provide professional consulting services to the Company.
+Added: Austrianova Singapore Pte.
+Added: (“Austrianova”);
+Added: and (ii) Austrianova Thailand Co., Ltd.
+Added: The Company purchased products
+Added: and services from these companies in the approximate amounts of $ 58,000 and $ 64,000 in the three months ended July 31, 2021 and
+Added: 2020, respectively.
+Added: In April 2014, the Company entered a
+Added: Consulting Agreement with Vin-de-Bona Trading Company, Pte.
+Added: (“Vin-de Bona”) pursuant to which it agreed to provide
+Added: professional consulting services to the Company.
Vin-de-Bona is owned by Prof.
−Removed: Günzburg (“Prof.
−Removed: Günzburg”) and Dr.
−Removed: Brian Salmons (“Dr.
−Removed: Salmons”),
−Removed: both of whom are involved in numerous aspects of the Company’s scientific endeavors relating to cancer and diabetes (Prof.
−Removed: Gunzburg is the Chairman and Chief Technical Officer of Austrianova, and Dr.
−Removed: Salmons is the Chief Executive Officer and President
−Removed: of Austrianova).
−Removed: The term of the agreement was for 12 months, automatically renewable for successive 12-month terms.
−Removed: initial term, either party can terminate the agreement by giving the other party 30 days’
−Removed: written notice before the effective
−Removed: date of termination.
+Added: Günzburg (“Prof.
+Added: Günzburg”) and Dr.
+Added: Brian Salmons (“Dr.
+Added: Salmons”), both of whom are involved in numerous aspects of the
+Added: Company’s scientific endeavors relating to cancer and diabetes (Prof.
+Added: Gunzburg is the Chairman of Austrianova, and Dr.
+Added: is the Chief Executive Officer and President of Austrianova).
+Added: The term of the agreement is for 12 months, automatically renewable
+Added: for successive 12-month terms.
+Added: After the initial term, either party can terminate the agreement by giving the other party 30
+Added: days’ written notice before the effective date of termination.
The agreement has been automatically renewed annually.
−Removed: The amounts incurred for the three and nine months
−Removed: ended January 31, 2021 were approximately $21,000 and $65,000, respectively, and $3,000 and $18,000 for the three and nine months
−Removed: ended January 31, 2020, respectively.
−Removed: In addition, during the nine months ended January 31, 2021 the Company issued 250,000 shares
−Removed: of common stock to Dr.
−Removed: Salmons to be a member of the Company’s Medical and Scientific Advisory Board.
−Removed: The Company recorded
−Removed: a noncash consulting expense of approximately $3,700 relating to this share issuance for the nine months ended January 31, 2021.
−Removed: During the year ended April 30, 2020, the
−Removed: Company issued one share of Series A Preferred Stock to the Chief Executive Officer of the Company for $1 pursuant to a Subscription
−Removed: The Series A Preferred Stock is described in detail in Note 12 –
−Removed: Preferred Stock.
−Removed: The Board exercised its right
−Removed: to have the Company redeem the one share of Series A Preferred Stock.
−Removed: It is no longer issued and outstanding.
−Removed: See Note 9 under Service Agreements for
−Removed: related party disclosures.
−Removed: NOTE 9 –
−Removed: COMMITMENTS AND CONTINGENCIES
+Added: amounts incurred for the three months ended July 31, 2021 and 2020 were approximately $ 32,000 and $ 23,000 , respectively.
+Added: addition, during the three months ended July 31, 2021 and 2020 the Company issued 0 and 167 shares of common stock, respectively, to
+Added: The Company recorded a noncash consulting expense of approximately $ 0 and $ 8,000 relating to these share issuances for
+Added: the three months ended July 31, 2021 and 2020, respectively.
+Added: NOTE 9 – COMMITMENTS AND CONTINGENCIES
The Company acquires assets still in development
−Removed: and enters R&D arrangements with third parties that often require milestone and royalty payments to the third-party contingent
−Removed: upon the occurrence of certain future events linked to the success of the asset in development.
−Removed: Milestone payments may be required,
−Removed: contingent upon the successful achievement of an important point in the development lifecycle of the pharmaceutical product (e.g.,
−Removed: approval of the product for marketing by a regulatory agency).
−Removed: If required by the license agreements, the Company may have to make
−Removed: royalty payments based upon a percentage of the sales of the pharmaceutical product if regulatory approval for marketing of the
−Removed: product candidate is obtained.
−Removed: Effective September 1, 2017, the Company
−Removed: entered into an office lease at 23046 Avenida de la Carlota, Suite 600, Laguna Hills, California (“Leased Premises”).
−Removed: The term of the lease was for 24 months and expired on August 31, 2019.
−Removed: In May 2019, the Company entered into an additional one-year
−Removed: lease for the Leased Premises, commencing upon the expiration of the term of the prior lease.
−Removed: The term of the lease expired on
−Removed: August 31, 2020.
−Removed: On May 28, 2020, the Company entered into
−Removed: an additional six-month lease of the Leased Premises, commencing on September 1, 2020.
−Removed: The term of the new lease expires on February
−Removed: On December 2, 2020, the Company entered into an additional six-month lease of the Leased Premises, commencing on March
−Removed: This lease expires on August 31, 2021.
−Removed: Rent expenses for these offices for the
−Removed: three months ended January 31, 2021 and 2020 were $5,288 and $7,152, respectively, and for the nine months ended January 31, 2021
−Removed: and 2020 were $17,824 and $23,812, respectively.
−Removed: The following table summarizes the Company’s
−Removed: aggregate future minimum lease payments required under the operating leases as of January 31, 2021.
+Added: and enters R&D arrangements with third parties that often require milestone and royalty payments to the third-party contingent upon
+Added: the occurrence of certain future events linked to the success of the asset in development.
+Added: Milestone payments may be required, contingent
+Added: upon the successful achievement of an important point in the development lifecycle of the pharmaceutical product (e.g., approval of the
+Added: product for marketing by a regulatory agency).
+Added: If required by the license agreements, the Company may have to make royalty payments based
+Added: upon a percentage of the sales of the pharmaceutical products if regulatory approval for marketing is obtained.
+Added: In May 2019, the Company entered into a lease
+Added: for its office space in California for a one-year lease for the leased premises.
+Added: The term of the lease expired on August 31, 2020.
+Added: On May 28, 2020, the Company entered into an additional
+Added: six-month lease of the office space, commencing on September 1, 2020.
+Added: The term of the new lease expired on February 28, 2021.
+Added: On May 24, 2021, the Company entered into an additional
+Added: six-month lease of the office space, commencing on September 1, 2021 which expires on February 28, 2022.
+Added: Rent expenses for the office for the three
+Added: months ended July 31, 2021 and 2020 were $ 3,738 and $ 7,152 , respectively.
+Added: The following table summarizes the Company’s
+Added: aggregate future minimum lease payments required under the operating lease as of:
+Added: Schedule of future minimum rental payments for operating leases
+Added: Period Ending April 30, 2022
Compensation Agreements
The Company entered into executive compensation
−Removed: agreements with its three executive officers in March 2015, each of which was amended in March 2017.
−Removed: Each agreement had a term
−Removed: of two years with automatic annual extensions thereafter unless the Company or the executive officer provides written notification
−Removed: of termination at least ninety days prior to the end of the term or subsequent extensions.
−Removed: Each agreement has been renewed.
−Removed: Company also entered a compensation agreement with a Board member in April 2015 which continued in effect until amended in May
+Added: agreements with its three executive officers in March 2015, each of which was amended in December 2015 and March 2017.
+Added: Each agreement
+Added: has a term of two years with annual extensions thereafter unless the Company or the officer provides written notification of termination
+Added: at least ninety days prior to the end of the term or subsequent extensions.
+Added: The Company also entered a compensation agreement with a Board
+Added: member in April 2015 which continued in effect until amended in May 2017.
In May 2017, the Company amended the compensation
−Removed: agreement with the Board members and the term continue in effect until a member is no longer on the Board.
+Added: agreement with the Board members and the terms continue in effect until a member is no longer on the Board.
The Company has four independent directors.
−Removed: Each director receives the same compensation:
+Added: director receives the same compensation:
(i) $12,500 in cash for each calendar quarter of service on the Board;
−Removed: fully-paid, non-assessable shares of the Company’s restricted common stock (“Shares”) annually;
−Removed: and (iii) a five-year
−Removed: option to purchase 500,000 Shares annually at an exercise price equal to the fair market value of the Shares on the date of grant.
−Removed: The Shares and the option Shares fully vest on the date of the grants.
−Removed: Service Agreements
−Removed: The Company entered into several service
−Removed: agreements with independent and related parties pursuant to which services will be provided over a specified period-of-time related
−Removed: to our IND which was placed on clinical hold by the FDA and proposed clinical trial involving LAPC.
−Removed: The services include regulatory
−Removed: affairs strategy, advice and follow up work on the IND and services related to having the clinical hold lifted.
−Removed: They also cover
−Removed: a 24-month stability study, which is approximately fifty percent complete, including the container closure integrity testing of
−Removed: the clinical trial product syringes.
−Removed: The total cost is estimated to be approximately $437,000, of which the related party portion
−Removed: will be approximately $310,000.
−Removed: These amounts take into account some of the cost associated with the work and preclinical studies
−Removed: required to lift the FDA’s clinical hold.
+Added: (ii) 333 fully paid, non-assessable
+Added: shares of the Company’s restricted common stock (“Shares”) annually;
+Added: and (iii) a five-year option to purchase 333 Shares
+Added: annually at an exercise price equal to the fair market value of the Shares on the date of grant.
+Added: The Shares and the option Shares fully
+Added: vest on the date of the grants.
NOTE 10 - INCOME TAXES
The Company had no income tax expense for
−Removed: the nine months ended January 31, 2021 and 2020, respectively.
−Removed: During the nine months ended January 31, 2021 and 2020, the Company
−Removed: had a net operating loss (“NOL”) for each period which generated deferred tax assets for NOL carryforwards.
+Added: the three months ended July 31, 2021 and 2020, respectively.
+Added: During the three months ended July 31, 2021 and 2020, the Company had a
+Added: net operating loss (“NOL”) for each period which generated deferred tax assets for NOL carryforwards.
provided valuation allowances against the net deferred tax assets including the deferred tax assets for NOL carryforwards.
−Removed: allowances provided for the net deferred tax asset increased by approximately $565,000 and $270,000 for the nine months ended January
+Added: allowances provided for the net deferred tax asset increased by approximately $ 295,000 and $ 98,000 for the three months ended July
31, 2021 and 2020, respectively.
−Removed: There was no material difference between
−Removed: the effective tax rate and the projected blended statutory tax rate for the nine months ended January 31, 2021 and 2020.
−Removed: Current tax laws limit the amount of loss
−Removed: available to be offset against future taxable income when a substantial change in ownership occurs.
−Removed: Therefore, the amount available
−Removed: to offset future taxable income may be limited.
−Removed: Based on the assessment of all available evidence including, but not limited to,
−Removed: the Company’s limited operating history in its core business and lack of profitability, uncertainties of the commercial viability
−Removed: of its technology, the impact of government regulations and healthcare reform initiatives and other risks normally associated with
−Removed: biotechnology companies, the Company has concluded that is more-likely-than-not that these operating loss carryforwards will not
−Removed: Accordingly, 100% of the deferred tax valuation allowance has been recorded against these assets at January 31, 2021.
−Removed: The Company’s policy is to recognize
+Added: There was no material difference between the effective
+Added: tax rate and the projected blended statutory tax rate for the three months ended July 31, 2021 and 2020.
+Added: Current tax laws limit the amount of loss available
+Added: to be offset against future taxable income when a substantial change in ownership occurs.
+Added: Therefore, the amount available to offset future
+Added: taxable income may be limited.
+Added: Based on the assessment of all available evidence including, but not limited to, the Company’s limited
+Added: operating history in its core business and lack of profitability, uncertainties of the commercial viability of its technology, the impact
+Added: of government regulations and healthcare reform initiatives and other risks normally associated with biotechnology companies, the Company
+Added: has concluded that is more-likely-than-not that these operating loss carryforwards will not be realized.
+Added: Accordingly, 100% of the deferred
+Added: tax valuation allowance has been recorded against these assets at July 31, 2021.
+Added: The Company’s policy is to recognize
any interest and penalties related to unrecognized tax benefits as a component of income tax expense.
−Removed: As of the nine months ended
−Removed: January 31, 2021 and 2020, the Company had no accrued interest or penalties related to uncertain tax positions.
−Removed: See Note 10 of Notes to the Consolidated
−Removed: Financial Statements included in the Company’s Annual Report on Form 10-K for the year ended April 30, 2020 for additional
−Removed: information regarding income taxes.
−Removed: NOTE 11 –
−Removed: EARNINGS PER SHARE
−Removed: Basic earnings (loss) per share is computed
−Removed: by dividing earnings (loss) available to common stockholders by the weighted average number of shares outstanding during the period.
−Removed: Diluted earnings (loss) per share is computed by dividing net income (loss) by the weighted average number of shares and potentially
−Removed: dilutive shares of common stock outstanding during the period increased to include the number of additional shares of common stock
−Removed: that would be outstanding if the potentially dilutive securities had been issued.
−Removed: Potential shares of common stock outstanding
−Removed: principally include stock options and warrants.
−Removed: During the nine months ended January 31, 2021 and 2020, the Company incurred losses.
−Removed: Accordingly, the effect of any common stock equivalent would be anti-dilutive during those periods and are not included in the
−Removed: calculation of diluted weighted average number of shares outstanding.
−Removed: The table below sets forth the basic loss
−Removed: per share calculations:
−Removed: Three Months Ended January 31,
−Removed: Basic weighted average number of shares outstanding
−Removed: 2,337,034,318
−Removed: 1,375,499,976
−Removed: Diluted weighted average number of shares outstanding
−Removed: 2,337,034,318
−Removed: 1,375,499,976
−Removed: Basic and diluted loss per share
−Removed: Nine Months Ended January 31,
+Added: As of the three months ended
+Added: July 31, 2021 and 2020, the Company had no accrued interest or penalties related to uncertain tax positions.
+Added: See Note 10 of Notes to the Consolidated Financial
+Added: Statements included in the Company’s Annual Report on Form 10-K for the year ended April 30, 2021 for additional information regarding
+Added: income taxes.
+Added: NOTE 11 – EARNINGS PER SHARE
+Added: Basic earnings (loss) per share is computed by
+Added: dividing earnings available to common stockholders by the weighted average number of shares outstanding during the period.
+Added: Diluted earnings
+Added: per share is computed by dividing net income by the weighted average number of shares and potentially dilutive shares of common stock
+Added: outstanding during the period increased to include the number of additional shares of common stock that would be outstanding if the potentially
+Added: dilutive securities had been issued.
+Added: Potential shares of common stock outstanding principally include stock options and warrants.
+Added: the periods ended July 31, 2021 and 2020, the Company incurred losses.
+Added: Accordingly, the effect of any common stock equivalent would be
+Added: anti-dilutive during those periods and are not included in the calculation of diluted weighted average number of shares outstanding.
+Added: The table below sets forth the basic loss per
+Added: share calculations:
+Added: Earnings per share calculations
+Added: Three months Ended July 31,
$ ( 1,025,418 )
1 unchanged sentence
Basic weighted average number of shares outstanding
−Removed: 2,108,274,833
−Removed: 1,284,500,731
Diluted weighted average number of shares outstanding
−Removed: 2,108,274,833
−Removed: 1,284,500,731
Basic and diluted loss per share
1 unchanged sentence
dilutive securities:
−Removed: Nine Months Ended January 31,
+Added: Schedule of potentially dilutive securities
+Added: Three months Ended July 31,
Excluded options
1 unchanged sentence
Total excluded options and warrants
−Removed: NOTE 12 –
−Removed: PREFERRED STOCK
−Removed: The Company has authorized 10,000,000
−Removed: shares of preferred stock, with a par value of $0.0001, of which one share has been designated as "Series A Preferred Stock".
−Removed: The one share of Series A Preferred Stock was issued on October 30, 2019 and redeemed by the Company on December 3, 2019.
−Removed: January 31, 2021, there are no shares of preferred stock issued and outstanding.
−Removed: The description of the Series A Preferred
−Removed: Stock below is qualified in its entirety by reference to the Company’s Articles of Incorporation, as amended.
+Added: NOTE 12 – PREFERRED STOCK
+Added: The Company has authorized 10,000,000 shares of
+Added: preferred stock, with a par value of $0.0001, of which one share has been designated as "Series A Preferred Stock".
+Added: share of Series A Preferred Stock was issued on October 30, 2019 and repurchased by the Company on December 3, 2019.
+Added: As of July 31, 2021,
+Added: there are no shares of preferred stock issued and outstanding.
+Added: The description of the Series A Preferred Stock
+Added: below is qualified in its entirety by reference to the Company’s Articles of Incorporation, as amended.
The Series A Preferred Stock has the following
4 unchanged sentences
The Series A Preferred Stock has no rights of transfer, conversion, dividends, preferences upon liquidation or participation in any distributions to shareholders.
−Removed: NOTE 13 –
−Removed: SUBSEQUENT EVENTS
−Removed: On March 1, 2021, the Company received
−Removed: notices of exercise for 26 Common Stock Purchase Warrants (“Warrants”).
−Removed: The holder of the Warrants elected to exercise
−Removed: the Warrants through a cashless exercise in accordance with the terms of the Warrants.
−Removed: This resulted in the Company issuing 43,715,269
−Removed: shares of unregistered common stock.
−Removed: Management’s Discussion and Analysis
−Removed: of Financial Condition and Results of Operations
−Removed: Cautionary Note Regarding Forward-Looking
−Removed: This Report includes “forward-looking
−Removed: statements”
−Removed: within the meaning of the federal securities laws.
−Removed: All statements other than statements of historical fact are
−Removed: “forward-looking statements”
−Removed: for purposes of this Report, including any projections of earnings, revenue or other financial
−Removed: items, any statements regarding the plans and objectives of management for future operations, any statements concerning proposed
−Removed: new products or services, any statements regarding future economic conditions or performance, any statements regarding expected
−Removed: benefits from any transactions and any statements of assumptions underlying any of the foregoing.
−Removed: In some cases, forward-looking
−Removed: statements can be identified by use of terminology such as “may,”
−Removed: “will,”
−Removed: “should,”
−Removed: “believes,”
−Removed: “intends,”
−Removed: “expects,”
−Removed: “plans,”
−Removed: “anticipates,”
−Removed: “estimates,”
−Removed: “goal,”
−Removed: “aim,”
−Removed: “potential”
−Removed: or “continue,”
−Removed: or the negative thereof or other comparable terminology regarding
−Removed: beliefs, plans, expectations or intentions regarding the future, including risks relating to the continuing outbreak of COVID-19.
−Removed: Although we believe that the expectations reflected in the forward-looking statements contained in this Report are reasonable,
−Removed: there can be no assurance that such expectations or any of the forward-looking statements will prove to be correct, and actual
−Removed: results could differ materially from those projected or assumed in the forward-looking statements.
−Removed: Thus, investors should refer
−Removed: to and carefully review information in future documents we file with the Commission.
−Removed: Our future financial condition and results
−Removed: of operations, as well as any forward-looking statements, are subject to inherent risk and uncertainties, including, but not limited
−Removed: to, the risk factors set forth in “Part I, Item 1A –
−Removed: Risk Factors”
−Removed: set forth in our Form 10-K for period ended
−Removed: April 30, 2020 and our Quarterly Reports on Form 10-Q and for the reasons described elsewhere in this Report.
−Removed: Among others, these
−Removed: include our estimates regarding expenses, future revenues, capital requirements and needs for additional financing;
−Removed: FDA lifts its clinical hold after we have submitted our responses to the FDA concerns related to our IND submission so that we
−Removed: can commence our planned clinical trial involving LAPC;
−Removed: the success and timing of our preclinical studies and clinical trials;
−Removed: the potential that results of preclinical studies and clinical trials may indicate that any of our technologies and product candidates
−Removed: are unsafe or ineffective;
−Removed: our dependence on third parties in the conduct of our preclinical studies and clinical trials;
−Removed: the difficulties
−Removed: and expenses associated with obtaining and maintaining regulatory approval of our product candidates;
−Removed: the material adverse impact
−Removed: that COVID-19 may have on our business, including our efforts to have the clinical hold lifted and our planned clinical trial involving
−Removed: LAPC, which could materially affect our operations as well as the business or operations of third parties with whom we conduct
−Removed: and whether the FDA will approve our product candidates after our clinical trials are completed, assuming the FDA allows
−Removed: our clinical trial to proceed after review of our clinical hold submission.
−Removed: All forward- looking statements and reasons why results
−Removed: may differ included in this Report are made as of the date hereof, and we do not intend to update any forward-looking statements
−Removed: except as required by law or applicable regulations.
−Removed: Except where the context otherwise requires, in this Report, the “Company,”
−Removed: “we,”
−Removed: “us”
−Removed: and “our”
−Removed: refer to PharmaCyte Biotech, Inc., a Nevada corporation, and, where appropriate,
−Removed: its subsidiaries.
−Removed: Product Candidates
−Removed: We are a biotechnology company focused
−Removed: on developing cellular therapies for cancer and diabetes based upon a proprietary cellulose-based live cell encapsulation technology
−Removed: known as “Cell-in-a-Box ®
−Removed: The Cell-in-a-Box ®
−Removed: technology is intended to be used as a
−Removed: platform upon which therapies for several types of cancer, including LAPC and Type 1 and insulin dependent Type 2 diabetes will
−Removed: be developed.
−Removed: We are developing therapies for pancreatic
−Removed: and other solid cancerous tumors by using genetically engineered live human cells that we believe are capable of converting a cancer
−Removed: prodrug into its cancer-killing form, encapsulating those cells using the Cell-in-a-Box ®
−Removed: technology and placing
−Removed: those capsules in the body as close as possible to the tumor.
−Removed: In this way, we believe that when the cancer prodrug is administered
−Removed: to a patient with a particular type of cancer that may be affected by the prodrug, the killing of the patient’s tumor may
−Removed: be optimized.
−Removed: We are also examining ways to exploit the
−Removed: benefits of the Cell-in-a-Box ®
−Removed: technology to develop therapies for cancer that involve prodrugs based upon certain
−Removed: constituents of the Cannabis plant;
−Removed: these constituents are of the class of compounds known as “cannabinoids”.
−Removed: Until the FDA allows us to commence the clinical trial involving LAPC described in our IND, which the FDA has placed a clinical
−Removed: hold, we will not spend any further resources developing this program.
−Removed: In addition, we are developing a therapy
−Removed: to delay the production and accumulation of malignant ascites fluid that results from many types of abdominal cancerous tumors.
−Removed: Malignant ascites fluid is secreted by abdominal cancerous tumors into the abdomen after the tumors have reached a certain stage
−Removed: This fluid contains cancer cells that can seed and form new tumors throughout the abdomen.
−Removed: This fluid accumulates in
−Removed: the abdominal cavity, causing swelling of the abdomen, severe breathing difficulties and extreme pain.
−Removed: We are using our therapy
−Removed: for pancreatic cancer to determine if it can prevent or delay the production and accumulation of malignant ascites fluid.
−Removed: our Cannabis program, until the FDA allows us to commence the clinical trial involving LAPC described in our IND, which
−Removed: the FDA has placed a clinical hold, we will not spend any further resources developing this program.
−Removed: We are also developing a therapy for Type
−Removed: 1 diabetes and insulin-dependent Type 2 diabetes.
−Removed: Our diabetes therapy consists of encapsulated genetically modified insulin-producing
−Removed: The encapsulation of the cell will be done using the Cell-in-a-Box ®
−Removed: Implanting these cells
−Removed: in the body is designed to function as a bio-artificial pancreas for purposes of insulin production.
−Removed: As with the two previous programs,
−Removed: we are not spending any further resources developing this program until the FDA allows us to commence the clinical trial involving
−Removed: LAPC described in our IND, which the FDA has placed a clinical hold.
−Removed: Finally, we had licensed from Hai Kang
−Removed: the right to certain technology owned or controlled by Hai Kang related to COVID-19 diagnostic Kits.
−Removed: Our license is both for the
−Removed: sale of Kits as well as for the use of the technology underlying the Kits.
−Removed: On November 19, 2020, we terminated the
−Removed: Hai Kang License Agreement.
−Removed: Clinical Hold
−Removed: On September 1, 2020, we submitted an IND
−Removed: to the FDA for a planned Phase 2b clinical trial in LAPC.
−Removed: Shortly thereafter, we received Information Requests from the FDA related
−Removed: We timely responded to all information requests.
−Removed: On October 1, 2020, we received notice
−Removed: that the FDA had placed our IND on clinical hold.
−Removed: On October 30, 2020, the FDA sent a letter
−Removed: to us setting forth the reasons for the clinical hold and specific guidance on what we must do to have the clinical hold lifted.
−Removed: In order to address the clinical hold, the FDA has requested
−Removed: Provide additional sequencing data and genetic stability studies;
−Removed: Conduct a stability study on the final formulated drug product as well as the cells from the Master Cell Bank;
−Removed: Evaluate the compatibility of the delivery devices (i.e., the prefilled syringe and microcatheter) with our drug product;
−Removed: Provide additional detailed description of the manufacturing process;
−Removed: Provide additional product release specifications for the encapsulated cells;
−Removed: Demonstrate comparability between the 1st and 2nd generation products and ensure adequate and consistent product performance and safety between the two generations of product;
−Removed: Conduct a biocompatibility assessment using the final finished capsules after the entire drug product manufacturing process (but without cells);
−Removed: Address insufficiencies in Chemistry, Manufacturing and Controls information in the cross-referenced Drug Master File;
−Removed: Conduct an additional nonclinical study to assess the safety, activity and distribution of the drug product;
−Removed: Revise the Investigators Brochure to include any additional preclinical studies conducted in response to the clinical hold and remove any statements not supported by the data;
−Removed: Provide data from a new and extensive pig study.
−Removed: The FDA also requested that we address
−Removed: several issues not related to the clinical hold in an amendment to the IND, including:
−Removed: Providing a Certificate of Analysis for pc3/2B1 plasmid that includes tests for assessing purity, safety, and potency;
−Removed: Performing qualification studies for the drug substance filling step to ensure that the product remains sterile and stable during the filling process;
−Removed: Submitting an updated batch analysis for the drug product for the specific lot that will be used for manufacturing all future drug product;
−Removed: Providing additional details for the methodology for the Resorufin (CYP2B1) potency and the PrestoBlue cell metabolic assays;
−Removed: Providing a few examples of common microcatheters that fit the specifications in the Angiography Procedure Manual;
−Removed: Clarifying the language in the Pharmacy Manual regarding proper use of the syringe fill with the drug product;
−Removed: Providing a discussion with data for the potential for cellular and humoral immune reactivity against the heterologous rat CYP2B1 protein and potential for induction of autoimmune-mediated toxicities in the Company’s study population.
−Removed: Since October 31, 2020, there has been
−Removed: no further communication with the FDA regarding the clinical hold.
−Removed: We have assembled a scientific team to
−Removed: address the FDA requests related to the clinical hold.
−Removed: That team is working to complete the items requested by the FDA.
−Removed: not yet determined the estimated cost or the time necessary to complete these items.
−Removed: The cost and time associated with completing
−Removed: these items will be significant.
−Removed: Thus far, we have successfully completed a 9-month product stability
−Removed: study, commenced physical parameter testing for CypCaps™
−Removed: and commenced additional studies for the sequence of DNA encoding
−Removed: of its encapsulated cells.
−Removed: We have also designed the biocompatibility tests for cytotoxicity, sensitization, irritation, acute
−Removed: systemic toxicity, material-mediated pyrogenicity, subacute/subchronic toxicity, genotoxicity and implantation.
−Removed: In addition, we
−Removed: have begun a compression and swelling study of CypCaps™, designed a study to determine if CypCaps™
−Removed: are adversely affected
−Removed: by contrast medium and designed a study to show the catheters used to implant CypCaps™
−Removed: do not adversely impact the encapsulated
−Removed: COVID-19 Potential Impact on the Financial Condition and
−Removed: Results of Operations
−Removed: COVID-19 is causing significant, industry-wide
−Removed: delays in clinical trials.
−Removed: Although we are not yet in a clinical trial, we have filed an IND with the FDA to commence a clinical
−Removed: trial in LAPC.
−Removed: While the IND has been placed on clinical hold by the FDA, we have assessed the impact of COVID-19 on our operations.
−Removed: Currently, many clinical trials are being delayed due to COVID-19.
−Removed: There are numerous reasons for these delays.
−Removed: For example, patients
−Removed: 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
−Removed: or doctor’s office.
−Removed: There are local, regional and state-wide orders and regulations restricting usual normal activity by
−Removed: These discourage and interfere with patient visits to a doctor’s office if the visit is not COVID-19 related.
−Removed: providers and health systems are shifting their resources away from clinical trials toward the care of COVID-19 patients.
−Removed: and other healthcare providers are making product candidates for the treatment of COVID-19 a priority over product candidates unrelated
−Removed: As of the date of this Report, the COVID-19 pandemic has had an impact upon our operations, although we believe that
−Removed: impact is not material.
−Removed: The impact primarily relates to delays in tasks associated with the preparation of our responses to the
−Removed: clinical hold, including all requested preclinical studies.
−Removed: There may be further delays in generating responses to the requests
−Removed: from the FDA related to the clinical hold.
−Removed: As a result of the COVID-19 pandemic, commencement
−Removed: of our planned clinical trial to treat LAPC may be delayed beyond the lifting of the clinical hold should that occur.
−Removed: Also, enrollment
−Removed: may be difficult for the reasons discussed above.
−Removed: In addition, after enrollment in the trial, if patients contract COVID-19 during
−Removed: their participation in the trial or are subject to isolation or shelter in place restrictions, this may cause them to drop out
−Removed: of our clinical trial, miss scheduled therapy appointments or follow-up visits or otherwise fail to follow the clinical trial protocol.
−Removed: If patients are unable to follow the clinical trial protocol or if the trial results are otherwise affected by the consequences
−Removed: of the COVID-19 pandemic on patient participation or actions taken to mitigate COVID-19 spread, the integrity of data from the
−Removed: clinical trial may be compromised or not be accepted by the FDA.
−Removed: This could further adversely impact or delay our clinical development
−Removed: It is highly speculative in projecting
−Removed: the effects of COVID-19 on our clinical development program and on us generally.
−Removed: The effects of COVID-19 quickly and dramatically
−Removed: change over time.
−Removed: Its evolution is difficult to predict, and no one is able to say with certainty when the pandemic will subside.
−Removed: COVID-19 could materially affect our operations,
−Removed: as well as the business or operations of third parties with whom we conduct business.
−Removed: Our business could be adversely affected
−Removed: by the effects of other future health pandemics in regions where we or third parties on which we rely have significant business
−Removed: See the risk factors set forth in “Part I, Item 1A –
−Removed: Risk Factors”
−Removed: set forth in our Form 10-K for
−Removed: period ended April 30, 2020 and for the risk factors described elsewhere in this Report.
−Removed: Performance Indicators
−Removed: Non-financial performance indicators used
−Removed: by management to manage and assess how the business is progressing will include, but are not limited to, the ability to:
−Removed: appropriate funding for all aspects of our operations;
−Removed: (ii) acquire and complete necessary contracts;
−Removed: (iii) complete activities
−Removed: for producing genetically modified human cells and having them encapsulated for our preclinical studies and the planned clinical
−Removed: trial in LAPC;
−Removed: (iv) respond to the issues raised by the FDA in its clinical hold on our IND and otherwise have regulatory work
−Removed: completed to enable studies and clinical trials to be submitted to regulatory agencies;
−Removed: (v) complete all required tests and studies
−Removed: on the cells and capsules we plan to use in our clinical trial in patients with LAPC;
−Removed: and (vi) ensure completion of the production
−Removed: of encapsulated cells according to current Good Manufacturing Practices regulations
−Removed: to use in our planned clinical trial involving LAPC.
−Removed: There are numerous items required to be
−Removed: completed successfully in order for the FDA’s clinical hold on our IND to be lifted and our final product candidate is ready
−Removed: for use in our planned clinical trial involving LAPC.
−Removed: The effects of material transactions with related parties, and certain other
−Removed: parties to the extent necessary for such an undertaking, may have substantial effects on both the timeliness and success of our
−Removed: current and prospective financial position and operating results.
−Removed: Nonetheless, we are actively working to ensure strong ties and
−Removed: interactions to minimize the inherent risks regarding success.
−Removed: We do not believe there are factors which will cause materially
−Removed: different amounts to be reported than those presented in this Report.
−Removed: We aim to assess this regularly to provide accurate information
−Removed: to our shareholders.
−Removed: Results of Operations
−Removed: Three and nine months ended January 31, 2021 compared
−Removed: to three and nine months ended January 31, 2020
−Removed: We had no revenues for the three and nine months ended January
−Removed: 31, 2021 and 2020.
−Removed: Operating Expenses and Loss from Operations
−Removed: The following table summarizes our operating
−Removed: expenses and loss from operations for the three and nine months ended January 31, 2021 and 2020, respectively:
−Removed: Three Months Ended January 31,
−Removed: Nine Months Ended January 31,
−Removed: The total operating expenses for
−Removed: the three-month period ended January 31, 2021 decreased by $118,461 from the three months ended January 31, 2020.
−Removed: is attributable to a decrease in general and administrative (“G&A”) expenses of $75,215, a decrease in director
−Removed: fees of $13,316, a decrease in legal and professional expense of $20,811 a decrease in compensation expense of $69,911, net of
−Removed: an increase in R&D expense of $60,792.
−Removed: The decrease in G&A expenses were mainly attributable to reductions in consulting
−Removed: fees and travel expenses.
−Removed: The total operating expenses for the nine-month
−Removed: period ended January 31, 2021 decreased by $488,467 from the nine months ended January 31, 2020.
−Removed: The decrease is attributable to
−Removed: a decrease in G&A expenses of $696,333, a decrease in director fees of $30,471, a decrease in compensation expense of $137,819,
−Removed: a decrease in legal and professional expense of $16,254, net of an increase in R&D expense of $392,410.
−Removed: The decrease in G&A
−Removed: expenses were mainly attributable to reductions in consulting fees and travel expenses.
−Removed: Other expense
−Removed: The following table sets forth our other expense for the three
−Removed: and nine months ended January 31, 2021 and 2020:
−Removed: Three Months Ended January 31,
−Removed: Nine Months Ended January 31,
−Removed: Total other expense for the three months
−Removed: ended January 31, 2021 increased by the amount of $249 from the three months ended January 31, 2020.
−Removed: The increase is attributable
−Removed: to the increase of interest expense in the amount of $249.
−Removed: Total other expense for the nine months
−Removed: ended January 31, 2021 increased by the amount of $3,194 from the nine months ended January 31, 2020.
−Removed: The increase is attributable
−Removed: to the increase of interest expense in the amount of $2,006, an increase in income taxes of $800 and an increase in foreign exchange
−Removed: losses of $388.
−Removed: Discussion of Operating, Investing and
−Removed: Financing Activities
−Removed: The following table presents a summary of our sources and uses
−Removed: of cash for the nine months ended January 31, 2021 and 2020, respectively:
−Removed: Nine Months Ended
−Removed: January 31, 2021
−Removed: January 31, 2020
−Removed: Net cash used in operating activities:
−Removed: $ (2,390,586 )
−Removed: $ (1,698,981 )
−Removed: Net cash provided by (used in) investing activities:
−Removed: Net cash provided by financing activities:
−Removed: Effect of currency rate exchange
−Removed: Net increase (decrease) in cash
−Removed: Operating Activities :
−Removed: The net cash used in operating activities
−Removed: for the nine months ended January 31, 2021 is a result of our net losses, decreases in accounts payable, accrued expenses and a
−Removed: decrease in prepaid expenses and an increase in securities issued for services and compensation.
−Removed: The cash used in operating activities
−Removed: for the nine months ended January 31, 2020 is a result of our net losses, offset by an increase in stock issued, a decrease in
−Removed: prepaid expenses and increases in accounts payable and accrued expenses.
−Removed: See Condensed Consolidated Statements of Cash Flows on
−Removed: Investing Activities :
−Removed: There were no investing activities in the nine months ended
−Removed: January 31, 2021 and 2020.
−Removed: Financing Activities :
−Removed: The cash provided from financing activities
−Removed: is mainly attributable to the proceeds from the sale of our common stock net of the use of funds for payment of director and officer
−Removed: insurance financing.
−Removed: Liquidity and Capital Resources
−Removed: As of January 31, 2021, our cash totaled
−Removed: approximately $3,091,000, compared to approximately $142,000 at January 31, 2020.
−Removed: Working capital was approximately $2,492,000
−Removed: at January 31, 2021 and approximately a negative $810,000 at January 31, 2020.
−Removed: The increase in cash is attributable to a higher
−Removed: beginning cash balance, an increase in proceeds from the sale of our common stock offset by a decrease in our operating expenses.
−Removed: During the nine months ended January 31,
−Removed: 2021, funding was provided by investors to maintain and expand our operations and R&D.
−Removed: Sales of our common stock were consummated
−Removed: using the S-3.
−Removed: During the nine months ended January 31, 2020, we continued to acquire funds through our S-3 pursuant to Block Trades
−Removed: transactions in a program which is structured to provide up to $25 million dollars to us less certain commissions pursuant to the
−Removed: As of August 13, 2020, we no longer met
−Removed: the eligibility requirements to use the S-3.
−Removed: In Note 2 –
−Removed: Going Concern to our
−Removed: Condensed Consolidated Financial Statements set forth in this Report, we note that certain conditions raise substantial doubt about
−Removed: our ability to continue as a going concern.
−Removed: However, we believe the cash on hand, the potential sales of unregistered shares of
−Removed: its common stock and any public offerings of common stock in which the Company may engage in will provide sufficient capital to
−Removed: meet the Company’s capital requirements and to fund the Company’s operations through March 31, 2022.
−Removed: Use of Estimates and Critical Accounting
−Removed: For a discussion regarding the Company’s
−Removed: use of estimates and critical accounting policies, see Note 2 “Summary of Significant Accounting Policies”
−Removed: to our Condensed Consolidated Financial Statements contained in this Report.
−Removed: Off-Balance Sheet Arrangements
−Removed: Except as described below, we have no off-balance
−Removed: sheet arrangements that could have a material current effect or that are reasonably likely to have a material adverse effect on
−Removed: our financial condition, changes in financial conditions, revenues or expenses, results of operations, liquidity, capital expenditures
−Removed: or capital resources.
−Removed: Service Agreements
−Removed: We entered into several service agreements
−Removed: with independent and related parties pursuant to which services will be provided over a specified period-of-time related to our
−Removed: IND which was placed on clinical hold by the FDA and proposed clinical trial involving LAPC.
−Removed: The services include regulatory affairs
−Removed: strategy, advice and follow up work on the IND and services related to having the clinical hold lifted.
−Removed: They also cover a 24-month
−Removed: stability study, which is approximately fifty percent complete.
−Removed: including the container closure integrity testing of the clinical
−Removed: trial product syringes.
−Removed: The total cost is estimated to be approximately $437,000, of which the related party portion will be approximately
−Removed: These amounts take into account some of the cost associated with the work and preclinical studies required to lift the
−Removed: FDA’s clinical hold.
−Removed: New Accounting Pronouncements
−Removed: For a discussion of all recently adopted
−Removed: and recently issued but not yet adopted accounting pronouncements, see Note 2 “Summary of Significant Accounting Policies”
−Removed: of the Notes to our Condensed Consolidated Financial Statements contained in this Report.
−Removed: Available Information
−Removed: Our website is located at www.PharmaCyte.com,
−Removed: In addition, all our filings submitted to the Commission, including our Annual Reports on Form 10-K, Quarterly Reports on Form
−Removed: 10-Q, Current Reports on Form 8-K and all our other reports and statements filed with the Commission are available on the Commission’s
−Removed: web site at www.sec.gov.
−Removed: Such filings are also available for download free of charge on our website.
−Removed: The contents of the website
−Removed: are not, and are not intended to be, incorporated by reference into this Report or any other report or document filed with the
−Removed: Commission or furnished by us, and any reference to the websites are intended to be inactive textual references only.
−Removed: Quantitative and
−Removed: Qualitative Disclosures About Market Risk.
−Removed: The information called for by Item 3 is
−Removed: not required for a smaller reporting company.
+Added: NOTE 13 – SUBSEQUENT EVENTS
+Added: Nasdaq Listing
+Added: Our common stock began trading on the Nasdaq Capital
+Added: Market on August 10, 2021, under the symbol “PMCB.” Prior to that, our common stock was quoted on the OTCQB Market under the
+Added: symbol “PMCB,” and following the reverse stock split of our common stock effective as of July 12, 2021, and until August 6,
+Added: 2021, the OTCQB Market Symbol for our common stock had temporarily been PMCBD.
+Added: August 2021 Underwritten Offering
+Added: On August 9, 2021, the Company entered into an
+Added: underwriting agreement with H.C.
+Added: Wainwright & Co.
+Added: LLC (“Wainwright”) with respect to a public offering of 2,630,385 shares
+Added: (“Shares”) of common stock, with a par value of $0.0001, 899,027 Pre-funded warrants (“Pre-funded Warrants”) to
+Added: purchase common stock and common stock warrants (“Common Warrants”) to purchase 3,529,412 shares of common stock.
+Added: gross proceeds of the offering before deduction of underwriting discounts, commissions and estimated offering expenses payable by the
+Added: Company was approximately $15 million pursuant to the Third S-3.
+Added: Each share of common stock (or pre-funded warrant in lieu thereof) was
+Added: sold together with one warrant to purchase one share of common stock at an effective combined public offering price of $4.25 per share
+Added: of common stock and accompanying warrant, less underwriting discounts and commissions.
+Added: The Common Warrants have an exercise price of $4.25
+Added: per share, are exercisable immediately, and will expire five years following the date of issuance.
+Added: The Pre-funded Warrants have an exercise
+Added: price of $0.001 per share, are exercisable immediately, and do not have an expiration date.
+Added: In addition, the Company granted the Underwriter
+Added: a 30-day option to purchase up to 529,411 Shares and/or Common Warrants at the public offering price, less underwriting discounts and
+Added: commissions, which the underwriter has partially exercised for Common Warrants to purchase an aggregate of up to 499,116 shares of common
+Added: August 2021 Registered Direct Offering and
+Added: Concurrent Private Placement
+Added: On August 19, 2021, the Company entered into a
+Added: Purchase Agreement with certain institutional investors.
+Added: Pursuant to the Purchase Agreement, the Company agreed to sell in a Registered
+Added: Direct Offering 8,430,000 shares (“Shares”) of the Company’s Common Stock, with a par value of $0.0001, and Pre-funded
+Added: warrants to purchase up to 5,570,000 shares of Common Stock.
+Added: The Pre-Funded Warrants have an exercise price of $0.001 per share and are
+Added: immediately exercisable and can be exercised at any time after their original issuance until such Pre-Funded Warrants are exercised in
+Added: Each Share was sold at an offering price of $5.00 and each Pre-Funded Warrant was sold at an offering price of $4.999 (equal to
+Added: the purchase price per Share minus the exercise price of the Pre-Funded Warrant).
+Added: Pursuant to the Purchase Agreement, in a concurrent
+Added: private placement (together with the Registered Direct Offering, the “August 19 Offerings”), the Company also agreed to issue
+Added: to the Purchasers unregistered warrants (“Series A Warrants”) to purchase up to 7,000,000 shares of Common Stock.
+Added: A Warrant has an exercise price of $5.00 per share, is exercisable immediately, and will expire five years following the date of issuance.
+Added: The Company receives gross proceeds from the August 19 Offerings, before deducting placement agent fees and other estimated offering expenses
+Added: payable by the Company, of approximately $70 million.
+Added: In addition, the Company issued to Wainwright
+Added: or its designees upon closing of the August 19 Offerings warrants (“Placement Agent Warrants”) to purchase 1,050,000 shares
+Added: of common stock at an exercise price of $6.25 per share (which represents 125% of the offering price per Share in the August 19 Offerings).
+Added: The Placement Agent Warrants will terminate five years after the date of commencement of sales in the Offerings.
+Added: August 2021 Warrant Exercises
+Added: As of August 18, 2021, all 899,027 of the
+Added: Pre-funded Warrants issued in the August 2021 underwritten offering have been exercised.
+Added: As of August 31, 2021, 2,522,387 of the Common
+Added: Warrants issued in the August 2021 underwritten offering have been exercised, for aggregate gross proceeds to the Company of $10,720,145.
+Added: As of August 31, 2021, 4,620,000 of the Pre-funded
+Added: Warrants issued in the August 19, 2021 Offerings have been exercised, for aggregate gross proceeds to the Company of $4,620.
Compared sentence by sentence after normalising whitespace, quotation marks, case and digits, so re-formatting and restated figures do not read as changed language. Wording changes appear as one removal and one addition. The current filing and the prior one are authoritative.