12 unchanged sentences
Accrued expenses
+Added: Current portion of Small Business Administration –
+Added: Paycheck Protection Program loan
Total current liabilities
+Added: Long-term liabilities, less current portion:
+Added: Small Business Administration –
+Added: Paycheck Protection Program loan
Total Liabilities
1 unchanged sentence
Stockholders' equity:
−Removed: Preferred stock, authorized 10,000,000 shares, $0.0001 par value:
−Removed: Series A Preferred Stock, 0 and 0 shares issued and outstanding as of January 31, 2020 and April 30, 2019,
−Removed: Common stock:
−Removed: authorized 2,490,000,000 shares, $0.0001 par value, 1,428,471,172 and 1,186,004,505 shares issued and outstanding as of January 31, 2020 and April 30, 2019, respectively
+Added: Common stock, authorized:
+Added: 2,490,000,000 shares, $0.0001 par value;
+Added: 1,875,143,738 and 1,638,637,839 shares issued and outstanding as of July 31, 2020 and April 30, 2020, respectively
Additional paid-in capital
5 unchanged sentences
Total Liabilities and Stockholders' Equity
−Removed: See accompanying Notes to Condensed Consolidated
−Removed: Financial Statements.
+Added: See accompanying Notes to Condensed
+Added: Consolidated Financial Statements.
PHARMACYTE BIOTECH, INC.
CONDENSED CONSOLIDATED STATEMENTS OF
−Removed: Three Months Ended
−Removed: Nine Months Ended
+Added: Three Months Ended July 31,
Operating expenses:
6 unchanged sentences
Loss from operations
−Removed: $ (3,076,505 )
+Added: Other expense:
+Added: Interest expense
+Added: Other expense
+Added: Total other expenses
$ (1,134,075 )
3 unchanged sentences
1,210,305,834
−Removed: 1,284,500,731
−Removed: 1,084,053,016
See accompanying Notes to Condensed Consolidated
3 unchanged sentences
COMPREHENSIVE LOSS
−Removed: Three Months Ended
−Removed: Nine Months Ended
−Removed: $ (3,076,505 )
+Added: Three Months Ended July 31,
$ (1,134,075 )
Other comprehensive income (loss):
−Removed: Foreign currency translation
+Added: Foreign currency translation adjustment
Other comprehensive income (loss)
1 unchanged sentence
$ (1,140,937 )
−Removed: $ (2,932,071 )
See accompanying Notes to Condensed Consolidated
2 unchanged sentences
CONDENSED CONSOLIDATED STATEMENT OF STOCKHOLDERS'
−Removed: NINE MONTHS ENDED JANUARY 31, 2020 AND
−Removed: A Preferred Stock
−Removed: Comprehensive Income
+Added: THREE MONTHS ENDED JULY 31, 2020 AND
+Added: Comprehensive
Stockholders’
3 unchanged sentences
$ (103,858,259 )
−Removed: Shares issued for compensation
−Removed: Shares issued for services
−Removed: Shares issued for cash,
−Removed: net of issuance costs of $70,000
−Removed: Stock options granted
+Added: Stock issued for compensation
+Added: Stock issued for services
+Added: Stock issued for cash, net
+Added: of issuance costs of $194,150
+Added: Stock-based compensation options
Foreign currency translation
2 unchanged sentences
$ 110,818,995
−Removed: Shares issued for compensation
−Removed: Shares issued for services
−Removed: Shares issued for cash,
−Removed: net of issuances costs of $24,500
−Removed: Share issued for cash
−Removed: Stock options granted
−Removed: Foreign currency translation
−Removed: Balance, October 31, 2019
$ (104,742,203 )
−Removed: (102,232,568 )
−Removed: Shares issued for compensation
−Removed: Shares issued for services
−Removed: Shares issued for cash
−Removed: Share repurchased for cash
−Removed: Stock options granted
−Removed: Foreign currency translation
−Removed: Balance, January 31,
−Removed: 1,428,471,172
−Removed: $ 107,305,733
−Removed: $ (103,107,876 )
Balance, April 30, 2019
2 unchanged sentences
$ (100,031,371 )
−Removed: Shares issued for compensation
−Removed: Shares issued for services
−Removed: Shares issued for cash,
−Removed: net of issuance costs of $105,000
−Removed: Stock options granted
+Added: Stock issued for compensation
+Added: Stock issued for services
+Added: Stock issued for cash, net
+Added: of issuance costs of $42,000
+Added: Stock-based compensation options
Foreign currency translation
2 unchanged sentences
$ 106,059,808
−Removed: Shares issued for compensation
−Removed: Shares issued for services
−Removed: Stock options granted
−Removed: Foreign currency translation
−Removed: Balance, October 31,
$ (101,165,446 )
−Removed: (98,216,080 )
−Removed: Shares issued for compensation
−Removed: Shares issued for services
−Removed: Shares issued for cash,
−Removed: net of issuance costs of $35,000
−Removed: Stock options granted
−Removed: Foreign currency translation
−Removed: Balance, January 31,
−Removed: 1,126,904,505
−Removed: $ 104,153,928
−Removed: $ (98,892,427 )
See accompanying Notes to Condensed Consolidated
2 unchanged sentences
CONDENSED CONSOLIDATED STATEMENTS OF
−Removed: Nine Months Ended January 31,
+Added: Three Months Ended July 31,
Cash flows from operating activities:
$ (1,134,075 )
−Removed: $ (2,928,284 )
Adjustments to reconcile net loss to net cash used in operating activities:
3 unchanged sentences
Change in assets and liabilities:
−Removed: Increase in prepaid expenses and other current assets
+Added: (Increase) decrease in prepaid expenses and other current assets
Increase (decrease) in accounts payable
−Removed: Increase in accrued expenses
+Added: Decrease in accrued expenses
Net cash used in operating activities
Cash flows from investing activities:
−Removed: Net cash used in investing activities
+Added: Net cash provided by (used in) investing activities
Cash flows from financing activities:
−Removed: Proceeds from sale of Series A Preferred Stock
−Removed: Repurchase 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
1 unchanged sentence
Effect of currency rate exchange on cash
−Removed: Net decrease in cash
+Added: Net increase (decrease) in cash
Cash at beginning of the period
1 unchanged sentence
Supplemental disclosure of cash flows information:
−Removed: Cash paid during the periods for taxes
+Added: Cash paid during the periods for
+Added: Cash paid during the periods for interest
+Added: Supplemental schedule of noncash investing and financing activity:
+Added: Issuance costs for shares issued
See accompanying Notes to Condensed Consolidated
6 unchanged sentences
(“Company”)
−Removed: is a biotechnology company focused on developing and preparing to commercialize cellular therapies for certain solid tumor cancers
−Removed: and diabetes based upon a proprietary cellulose-based live cell encapsulation technology known as “Cell-in-a-Box ®
+Added: is a biotechnology company focused on developing cellular therapies for cancer and diabetes based upon a proprietary cellulose-based
+Added: live cell encapsulation technology known as “Cell-in-a-Box ®
The Cell-in-a-Box ®
−Removed: technology is intended to be used as a platform upon which therapies for several types of cancer,
−Removed: including locally advanced, inoperable, non-metastatic pancreatic cancer (“LAPC”), and Type 1 and insulin-dependent
−Removed: Type 2 diabetes are being developed.
+Added: is intended to be used as a platform upon which therapies for several types of cancer, including locally advanced, inoperable,
+Added: pancreatic cancer (“LAPC”), and Type 1 and insulin dependent Type 2 diabetes will be developed.
The Company is developing therapies for
−Removed: pancreatic and other solid cancerous tumors by using genetically engineered live human cells that are capable of converting a cancer
−Removed: prodrug into its cancer-killing form, by encapsulating those cells using the Cell-in-a-Box ®
−Removed: technology and placing
−Removed: those capsules in the blood supply as close as possible to the cancerous tumor.
−Removed: In this way, when the cancer prodrug is administered
−Removed: to a patient with a particular type of cancer that may be affected by the active form of the prodrug, the killing of the patient’s
+Added: pancreatic and other solid cancerous tumors by using genetically engineered live human cells that it believes are capable of converting
+Added: a cancer prodrug into its cancer-killing form, encapsulating those cells using the Cell-in-a-Box ®
+Added: technology and
+Added: placing those capsules in the body as close as possible to the tumor.
+Added: In this way, the Company believes that when the cancer prodrug
+Added: is administered to a patient with a particular type of cancer that may be affected by the prodrug, the killing of the patient’s
tumor may be optimized.
−Removed: The Company has been examining ways to
−Removed: exploit the benefits of the Cell-in-a-Box ®
−Removed: encapsulation technology to develop therapies for cancer that involve
−Removed: prodrugs based upon certain constituents of the Cannabis plant;
−Removed: these constituents are of the class of compounds known as
−Removed: “cannabinoids.”
−Removed: Until the IND involving LAPC has been submitted to the FDA, the Company will not be spending any further
−Removed: resources developing this program.
−Removed: In addition, the Company has been involved
−Removed: in preclinical studies to determine if its cancer therapy can slow the production and/or accumulation of malignant ascites fluid
−Removed: in the abdomen that often accompanies the growth of several types of abdominal cancers.
−Removed: Until the IND involving LAPC has been submitted
−Removed: to the FDA, the Company will not be spending any further resources developing this program.
−Removed: Finally, the Company has been developing
−Removed: a therapy for Type 1 diabetes and insulin-dependent Type 2 diabetes based upon the encapsulation of a human liver cell line genetically
−Removed: engineered to produce, store and secrete insulin at levels in proportion to the levels of blood sugar in the human body.
−Removed: is also exploring the possibility of encapsulating human insulin-producing stem cells and islet cells and transplanting them into
−Removed: a diabetic patient.
−Removed: All three types of cells will be encapsulated using the Cell-in-a-Box ®
−Removed: encapsulation technology.
−Removed: Each method is designed to function as a bio-artificial pancreas for purposes of insulin production.
−Removed: Until the IND involving LAPC
−Removed: has been submitted to the FDA, the Company will not be spending any further resources developing this program.
−Removed: The Cell-in-a-Box ®
−Removed: are largely composed of cellulose (cotton) and are bio-inert in the human body.
−Removed: The Cell-in-a-Box encapsulation technology potentially
−Removed: enables genetically engineered live human cells to be used as miniature factories.
−Removed: The technology results in the formation of pin-head
−Removed: sized cellulose-based porous capsules in which genetically modified live human cells can be encapsulated and maintained.
−Removed: protected from environmental challenges, such as the sheer forces associated with bioreactors, passage through catheters and needles,
−Removed: etc., enabling greater growth and production of the end-product.
−Removed: Cancer Therapy
−Removed: Targeted Chemotherapy
−Removed: The Company is seeking to utilize the Cell-in-a-Box ®
−Removed: encapsulation technology to develop a therapy for certain solid cancerous tumors through targeted chemotherapy.
−Removed: For pancreatic
−Removed: cancer, the Company is encapsulating genetically engineered live human cells that produce an enzyme designed to convert the prodrug
−Removed: ifosfamide into its cancer-killing form.
−Removed: The capsules containing these cells will be implanted in a patient in the blood supply
−Removed: to the pancreas as near as possible to the tumor in the pancreas.
−Removed: The cancer prodrug ifosfamide will then be given intravenously
−Removed: at a very low dose (1 g/m 2 ).
−Removed: It is believed that the ifosfamide will be converted at the site of the tumor in addition
−Removed: to the liver where it is normally converted.
−Removed: The Company believes placement of the Cell-in-a-Box ®
−Removed: capsules in close
−Removed: proximity to the tumor enables the production of optimal concentrations of the “cancer-killing”
−Removed: form of ifosfamide
−Removed: at the site of the tumor.
−Removed: The cancer-killing metabolite of ifosfamide has a short half-life, which the Company believes will result
−Removed: in little to no side effects from the chemotherapy.
−Removed: Pancreatic Cancer Therapy for LAPC
−Removed: A critical unmet medical need exists for
−Removed: patients with LAPC whose tumor in the pancreas no longer responds after 4-6 months of treatment with either Abraxane ®
−Removed: plus gemcitabine or the 4-drug combination known as FOLFIRINOX (both combinations are the current standards of care for pancreatic
−Removed: We believe these patients have no effective treatment alternative once their tumors stop responding to these therapies.
−Removed: Two of the most commonly used treatments for such patients are 5-fluorouiracil (“5-FU”) or capecitabine (a prodrug
−Removed: of 5-FU) plus radiation (chemoradiation therapy).
−Removed: Both treatments are only marginally effective in treating the tumor in the pancreas
−Removed: and result in serious side effects.
−Removed: More recently, radiation treatment alone is being used at some cancer centers in the United
−Removed: States (“U.S.”).
−Removed: The Company is developing a therapy comprised of Cell-in-a-Box ®
−Removed: encapsulated live cells
−Removed: implanted as close as possible to the cancerous tumor in a patient’s pancreas followed by low doses of the cancer prodrug
−Removed: ifosfamide administered intravenously.
−Removed: The Company believes that its treatment can serve as a “consolidation therapy”
−Removed: with the current standards of care for patients with LAPC and thus address this critical unmet medical need.
−Removed: Subject to approval by the U.S.
−Removed: Drug Administration (“FDA”), the Company plans to commence a clinical trial involving patients with LAPC whose tumors
−Removed: have ceased to respond to either Abraxane ®
−Removed: plus gemcitabine or FOLFIRINOX after 4-6 months of treatment.
−Removed: had a Pre-Investigational New Drug Application meeting (“Pre-IND meeting”) with the Center for Biologics Evaluation
−Removed: and Research of the FDA (“CBER”) in January 2017.
−Removed: At that Pre-IND meeting, the FDA communicated its agreement with
−Removed: certain aspects of the Company’s clinical development plan, charged the Company with completing numerous tasks and provided
−Removed: the Company with the guidance on the tasks the Company believes is needed to complete a successful IND, although no assurance can
−Removed: be given whether the FDA will approve the Company’s IND for LAPC once it is submitted to the FDA.
−Removed: Since the pre-IND meeting,
−Removed: the Company has completed the Cell-in-a-Box ®
−Removed: engineering runs and manufacturing production runs along with most
−Removed: of the studies intended to provide data necessary for the completion of the Company’s IND for LAPC.
−Removed: The Company is continuing to work on projects
−Removed: related to its planned IND submission for LAPC.
−Removed: Among other things, this work includes completion of each Module within the IND,
−Removed: the Investigator’s Brochure, the Pharmacy Manual, the Protocol for the LAPC clinical trial, a container closure integrity
−Removed: test of the Company’s clinical trial product that will be conducted over the course of two years, a pyrogenicity test, preparation
−Removed: of the angiography guidelines for implantation of the encapsulated cells for use in the LAPC clinical trial and a two-year stability
−Removed: study of the Company’s clinical trial product.
−Removed: The work also includes preparation of a Drug Master File, drafting change
−Removed: history related to the manufacturing process that existed when the preclinical studies were conducted compared to the current manufacturing
−Removed: process for the Company’s clinical trial product and publication of the IND in concert with the Company’s U.S.
−Removed: The Company will need to raise additional funds to complete preparation of its IND submission to the FDA for the treatment
−Removed: The plan is to initially conduct the LAPC
−Removed: trial in the U.S.
−Removed: with possible study sites in Europe at a later date.
−Removed: Cannabinoid Therapy to Treat Cancer
−Removed: The Company plans to use cannabinoids,
−Removed: constituents of the Cannabis plant, to develop therapies for cancer, with the initial target of brain cancer.
−Removed: is focusing on developing specific therapies based on carefully chosen molecules rather than using complex Cannabis extracts.
−Removed: To further its Cannabis therapy
−Removed: development plans, the Company entered a Research Agreement with the University of Northern Colorado.
−Removed: The initial goal of the research
−Removed: was to develop methods for the identification, separation and quantification of constituents of Cannabis (some of which
−Removed: are prodrugs) that may be used in combination with the Cell-in-a-Box ®
−Removed: technology to treat cancer.
−Removed: This has been
−Removed: accomplished.
−Removed: Further research has been conducted to
−Removed: identify the appropriate cell type that can convert the selected cannabinoid prodrugs into metabolites with anticancer activity.
−Removed: Once identified, the genetically modified cells that will produce the appropriate enzyme to convert the selected prodrugs will
−Removed: be encapsulated using the Company’s Cell-in-a-Box ®
−Removed: The encapsulated cells and cannabinoid prodrugs
−Removed: identified by these studies will then be combined and used for future studies to evaluate their anticancer effectiveness.
−Removed: Malignant Ascites Fluid Therapy
−Removed: The Company has also been developing a
−Removed: therapy to delay the production and accumulation of malignant ascites fluid that results from many types of abdominal tumors.
−Removed: ascites fluid is secreted by abdominal tumors into the abdomen after the tumors have reached a certain stage of growth.
−Removed: contains cancer cells that can seed and form new tumors throughout the abdomen.
−Removed: This fluid accumulates in the abdominal cavity,
−Removed: causing swelling of the abdomen, severe breathing difficulties and extreme pain.
−Removed: Once an abdominal tumor reaches a certain
−Removed: stage of development, it produces malignant ascites in the abdominal cavity.
−Removed: Malignant ascites fluid must be removed by paracentesis
−Removed: (a clinical procedure in which a needle is inserted into the peritoneal cavity and ascites fluid is removed) on a periodic basis.
−Removed: This procedure is painful and costly.
−Removed: There is no therapy that the Company is aware of that prevents or delays the production and
−Removed: accumulation of malignant ascites fluid.
−Removed: The Company has been involved in a series
−Removed: of preclinical studies conducted by Translational Drug Development (“TD2”), an early stage CRO specializing in oncology,
−Removed: to determine if the combination of Cell-in-a-Box ®
−Removed: encapsulated cells plus ifosfamide therapy can delay the
−Removed: production and accumulation of malignant ascites fluid.
−Removed: The data from the TD2 studies indicated that the treatment might play a
−Removed: role in the rate of malignant ascites fluid production and accumulation, but the conclusions were difficult to interpret with certainty.
−Removed: As a result, the Company plans to conduct another preclinical study in Germany to determine if its conclusions from the TD2 studies
−Removed: If this European study shows positive results, the Company plans to seek approval from the FDA to conduct a Phase 1
−Removed: clinical trial in the U.S.
−Removed: Diabetes Therapy
−Removed: Bio-Artificial Pancreas for Diabetes
−Removed: The Company plans to develop a therapy
+Added: On September 1, 2020, the Company submitted an Investigational New Drug Application (“IND”)
+Added: Food and Drug Administration (“FDA”) for a planned Phase 2b clinical trial in LAPC.
+Added: On September 4, 2020,
+Added: the Company received an Information Request from the FDA.
+Added: The Company responded to the FDA’s Information Request on September
+Added: See Note 13 “Subsequent Events”.
+Added: The Company is also examining ways to exploit
+Added: the benefits of the Cell-in-a-Box ®
+Added: technology to develop therapies for cancer that involve prodrugs based upon certain
+Added: constituents of the Cannabis plant;
+Added: these constituents are of the class of compounds known as “cannabinoids.”
+Added: Until the FDA allows the Company to commence the clinical trial involving LAPC described in the Company’s recently filed
+Added: IND, the Company is not spending any further resources developing this program.
+Added: In addition, the Company is developing
+Added: a therapy to delay the production and accumulation of malignant ascites fluid that results from many types of abdominal cancerous
+Added: Malignant ascites fluid is secreted by abdominal cancerous tumors into the abdomen after the tumors have reached a certain
+Added: stage of growth.
+Added: This fluid contains cancer cells that can seed and form new tumors throughout the abdomen.
+Added: This fluid accumulates
+Added: in the abdominal cavity, causing swelling of the abdomen, severe breathing difficulties and extreme pain.
+Added: The Company is using its therapy for pancreatic
+Added: cancer to determine if it can prevent or delay the production and accumulation of malignant ascites fluid.
+Added: As with the Company’s
+Added: Cannabis program, until the FDA allows it to commence the clinical trial involving LAPC described in its recently filed IND, the
+Added: Company is not spending any further resources developing this program.
+Added: The Company is also developing a therapy
for Type 1 diabetes and insulin-dependent Type 2 diabetes.
−Removed: The Company has been developing a therapy that involves encapsulation
−Removed: of human liver cells that have been genetically engineered to produce, store and release insulin on demand at levels in proportion
−Removed: to the levels of blood sugar (glucose) in the human body.
−Removed: The Company is also exploring the possibility of using genetically modified
−Removed: stem cells and natural, human insulin-producing cells (beta islet cells) to treat Type 1 diabetes and insulin-dependent Type 2
−Removed: All three types of cells will be encapsulated using the Cell-in-a-Box ®
−Removed: encapsulation technology.
−Removed: for the three approaches is to develop a bio-artificial pancreas for purposes of insulin production for diabetics who are insulin
−Removed: After appropriate animal testing has been completed successfully, the Company plans to seek the FDA’s approval
−Removed: to transplant encapsulated insulin-producing cells into diabetic patients.
−Removed: The goal for these approaches is to develop a bio-artificial
−Removed: pancreas for purposes of insulin production for diabetics who are insulin-dependent.
−Removed: Company Background and Material Agreements
+Added: The Company’s diabetes therapy consists of encapsulated genetically
+Added: modified human liver cells and insulin-producing stem cells.
+Added: The encapsulation for each type of cell will be done using the Cell-in-a-Box ®
+Added: Implanting these cells in the body is designed to function as a bio-artificial pancreas for purposes of insulin production.
+Added: As with the two previous programs, the Company is not spending any further resources developing this program until the FDA allows
+Added: it to commence the clinical trial involving LAPC described in its recently filed IND.
+Added: Additionally, work at the University of Technology,
+Added: Sydney (“UTS”) on the Melligen cells continues.
+Added: Melligen cells are human liver cells that have been genetically engineered
+Added: to produce, store and release insulin in response to the levels of blood sugar in the body.
+Added: Finally, the Company has licensed (“Hai
+Added: Kang License Agreement”) from Hai Kang Life Corporation (“Hai Kang”) the right to certain technology owned or
+Added: controlled by Hai Kang related to SARS-Cov2 COVID-19 diagnostic kits (“Kits”).
+Added: The Company’s license is both for
+Added: the sale of Kits as well as for the use of the technology underlying the Kits.
+Added: Pursuant to the Hai Kang License Agreement, the
+Added: Company may directly (or through a third party) conduct research, use, develop, market, sell, distribute, import and export Kits
+Added: and utilize their underlying technology for human and veterinary uses in North America, the United Kingdom and certain other European
+Added: A Kit is defined as any existing Kit of Hai Kang or any future Kit derived from Hai Kang’s Kits.
+Added: The Kits will be
+Added: manufactured and supplied to the Company by Hai Kang.
+Added: With respect to the Hai Kang License Agreement and related products, including
+Added: the Kits, we may not be able to (i) develop a related product candidate with our current resources, on a timely basis, or at all;
+Added: (ii) obtain the necessary regulatory authorizations or approvals for such a product candidate or for a Kit;
+Added: (iii) commercialize
+Added: any such product candidate or Kit;
+Added: or (iv) obtain reimbursement for such a product candidate or Kit in the U.S.
+Added: and elsewhere.
+Added: It is uncertain that any such product candidates or Kit will comply with U.S.
+Added: regulatory requirements or that any health care
+Added: facility or provider will be willing or able to use such product candidates or Kits.
+Added: Impact of the COVID-19 Pandemic on the Company’s Operations
+Added: The coronavirus SARS-Cov2 (“COVID-19”)
+Added: pandemic is causing significant, industry-wide delays in clinical trials.
+Added: Although the Company is not yet in a clinical trial,
+Added: the Company has filed an IND with the FDA to commence a clinical trial in LAPC and is awaiting a response from the FDA.
+Added: many clinical trials are being delayed due to COVID-19.
+Added: There are numerous reasons for these delays.
+Added: For example, patients have
+Added: shown a reluctance to enroll or continue in a clinical trial due to fear of exposure to COVID-19 when they are in a hospital or
+Added: doctor’s office.
+Added: There are local, regional and state-wide orders and regulations restricting 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 related.
+Added: providers and health systems are shifting their resources away from clinical trials toward the care of COVID-19 patients.
+Added: 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 this Report on Form 10-Q (“Report”), the COVID-19 pandemic has had an impact
+Added: upon the Company’s operations, although the Company believes that impact is not material.
+Added: The impact primarily relates to
+Added: delays in tasks associated with the preparation of the Company’s recently submitted IND to treat LAPC.
+Added: There may be further
+Added: delays in generating responses required by the Company to comments by or requests from the FDA related to the IND.
+Added: As a result of the COVID-19 pandemic, commencement
+Added: of the Company’s planned clinical trial to treat LAPC may be delayed.
+Added: Also, enrollment may be difficult for the reasons discussed
+Added: In addition, after enrollment in the trial, if patients contract COVID-19 during their participation in the trial or are
+Added: subject to isolation or shelter in place restrictions, this may cause them to drop out of our trial, miss scheduled therapy appointments
+Added: or follow-up visits or otherwise fail to follow the trial protocol.
+Added: If patients are unable to follow the trial protocol or if the
+Added: trial results are otherwise affected by the consequences of the COVID-19 pandemic on patient participation or actions taken to
+Added: mitigate COVID-19 spread, the integrity of data from the trial may be compromised or not be accepted by the FDA.
+Added: This could impact
+Added: or delay the Company’s clinical development program.
+Added: It is highly speculative in projecting
+Added: the effects of COVID-19 on the Company’s clinical development program and the Company generally.
+Added: The effects of COVID-19
+Added: quickly and dramatically change over time.
+Added: Its evolution is difficult to predict, and no one is able to say with certainty when
+Added: the pandemic will subside and life as we knew it before the pandemic will return to normal.
+Added: Company Background
The Company is a Nevada corporation incorporated
2 unchanged sentences
focusing all its efforts upon the development of a novel, effective and safe way to treat cancer and diabetes.
−Removed: On January 6, 2015,
+Added: In January 2015,
the Company changed its name from Nuvilex, Inc.
to PharmaCyte Biotech, Inc.
−Removed: to reflect the nature of its business in the biotechnology
−Removed: In 2011, the Company entered into an Asset
−Removed: Purchase Agreement (“SG Austria APA”) with SG Austria Private Limited (“SG Austria”) to purchase 100% of
−Removed: the assets and liabilities of SG Austria.
−Removed: Austrianova Singapore Pte.
−Removed: (“Austrianova”) and Bio Blue Bird AG (“Bio
−Removed: Blue Bird”), then wholly-owned subsidiaries of SG Austria, were to become wholly-owned subsidiaries of the Company on the
−Removed: condition that the Company pay SG Austria $2.5 million and 100,000,000 shares of the Company’s common stock (“Common
−Removed: Stock”).
−Removed: The Company was to receive 100,000 shares of common stock of Austrianova and nine bearer shares of Bio Blue Bird
−Removed: representing 100% of the ownership of Bio Blue Bird.
−Removed: Through two addenda to the SG Austria APA,
−Removed: the closing date of the SG Austria APA was extended twice by agreement between the parties.
+Added: to reflect the nature of its current business.
+Added: Commencing in May 2011, the Company entered
+Added: into a series of agreements and amendments with SG Austria to acquire certain assets from SG Austria as well as an exclusive, worldwide
+Added: license to use, with a right to sublicense, the Cell-in-a-Box ®
+Added: technology and trademark for the development of therapies
+Added: (“SG Austria APA”)
In June 2013, the Company and SG Austria
entered a Third Addendum to the SG Austria APA (“Third Addendum”).
−Removed: The Third Addendum changed materially the transaction
+Added: The Third Addendum materially changed the transaction
contemplated by the SG Austria APA.
1 unchanged sentence
and received a 14.5% equity interest in SG Austria.
−Removed: In addition, the Company received nine bearer shares of Bio Blue Bird to reflect
−Removed: its 100% ownership of Bio Blue Bird.
The Company paid:
(i) $500,000 to retire all outstanding debt of Bio Blue Bird;
−Removed: and (ii) $1.0
−Removed: million to SG Austria.
−Removed: The Company also paid SG Austria $1,572,193 in exchange for the 14.5% equity interest of SG Austria.
−Removed: Third Addendum required SG Austria to return the 100,000,000 shares of Common Stock held by SG Austria and for the Company to return
−Removed: the 100,000 shares of common stock of Austrianova the Company held.
−Removed: Effective as of the same date of the Third
−Removed: Addendum, the parties entered into a Clarification Agreement to the Third Addendum (“Clarification Agreement”) to clarify
−Removed: and include certain language that was inadvertently omitted from the Third Addendum.
−Removed: Among other things, the Clarification Agreement
−Removed: confirmed that the Third Addendum granted the Company an exclusive, worldwide license to use, with a right to sublicense, the Cell-in-a-Box ®
−Removed: encapsulation technology for the development of treatments for cancer and use of Austrianova’s Cell-in-a-Box ®
−Removed: and its associated technology.
+Added: and (ii) $1.0 million to SG Austria.
+Added: The Company also paid SG Austria $1,572,193 in exchange for a 14.5% equity interest of SG
+Added: The transaction required SG Austria to return to the Company the 100,000,000 shares of our common stock held by SG Austria
+Added: and for the Company to return to SG Austria the 100,000 shares of common stock of Austrianova which the Company held.
+Added: Effective as of the same date the Company
+Added: entered into the Third Addendum, the Company and SG Austria also entered into a Clarification Agreement to the Third Addendum (“Clarification
+Added: Agreement”) to clarify and include certain language that was inadvertently left out of the Third Addendum.
+Added: Among other things,
+Added: the Clarification Agreement confirmed that the Third Addendum granted the Company an exclusive, worldwide license to use, with
+Added: a right to sublicense, the Cell-in-a-Box ®
+Added: Trademark and its Associated Technology for the development of therapies
With respect to Bio Blue Bird, Bavarian
1 unchanged sentence
Gesundheit GmbH (collectively, “Bavarian
−Removed: Nordic/GSF”) and Bio Blue Bird entered into the Bavarian Nordic/GSF License Agreement in July 2005 whereby Bio Blue Bird
−Removed: was granted a non-exclusive license to develop, make or have made products to treat cancer, obtain marketing approval, sell and
−Removed: offer for sale those products using the clinical data generated from the second pancreatic cancer clinical trial which contained
−Removed: proprietary information from the 1 st Interim Analysis of the trial that used the cells and capsules developed by Bavarian
−Removed: Nordic/GSF (then known as “CapCells”).
−Removed: The licensed patent rights related to this information and technology pertain
−Removed: to the countries in which patents had been granted to Bavarian Nordic/GSF.
+Added: Nordic/GSF”) and Bio Blue Bird entered into a non-exclusive License Agreement (“Bavarian Nordic/GSF License Agreement”)
+Added: in July 2005, whereby Bio Blue Bird was granted a non-exclusive license to further develop, make, have made (including services
+Added: under contract for Bio Blue Bird or a sub-licensee, by Contract Manufacturing Organizations, Contract Research Organizations, Consultants,
+Added: Logistics Companies or others), obtain marketing approval, sell and offer for sale the clinical data generated from the pancreatic
+Added: cancer clinical trials that used the cells and capsules developed by Bavarian Nordic/GSF (then known as “CapCells”)
+Added: or otherwise use the licensed patent rights related thereto in the countries in which patents had been granted.
+Added: Bio Blue Bird was
+Added: required to pay Bavarian Nordic a royalty of 3% of the net sales value of each licensed product sold by Bio Blue Bird and/or its
+Added: Affiliates and/or its sub-licensees to a buyer.
+Added: The term of the Bavarian Nordic/GSF License Agreement continued on a country by
+Added: country basis until the expiration of the last valid claim of the licensed patent rights.
Bavarian Nordic/GSF and Bio Blue Bird amended
−Removed: the Bavarian Nordic License Agreement in December 2006 to reflect:
+Added: the Bavarian Nordic License Agreement in December 2006 (“First Amendment to Bavarian Nordic/GSF License Agreement”)
+Added: to reflect that:
(i) the license granted was exclusive;
−Removed: (ii) the royalty rate
−Removed: increased from 3% to 4.5%;
−Removed: (iii) Bio Blue Bird assumed the patent prosecution expenses for the existing patents;
−Removed: and (iv) it was
−Removed: made clear that the license will survive as a license granted by one of the licensors if the other licensor rejects performance
−Removed: under the Bavarian Nordic License Agreement due to any actions or declarations of insolvency.
+Added: (ii) a royalty rate increased from 3% to 4.5%;
+Added: (iii) Bio Blue Bird assumed
+Added: the patent prosecution expenses for the existing patents;
+Added: and (iv) to make clear that the license will survive as a license granted
+Added: by one of the licensors if the other licensor rejects performance under the Bavarian Nordic License Agreement due to any actions
+Added: or declarations of insolvency.
In June 2013, the Company acquired from
Austrianova an exclusive, worldwide license to use the Cell-in-a-Box ®
−Removed: technology and trademark for the development
−Removed: of a therapy for Type 1 and insulin-dependent Type 2 diabetes (“Diabetes Licensing Agreement”).
+Added: Trademark and its Associated Technology for
+Added: the development of a therapy for Type 1 and insulin-dependent Type 2 diabetes (“Diabetes Licensing Agreement”).
+Added: allows the Company to develop a therapy to treat diabetes through encapsulation of a human cell line that has been genetically
+Added: modified to produce, store and release insulin in response to the levels of blood sugar in the human body.
In October 2014, the Company entered into
−Removed: an exclusive, worldwide license agreement (“Melligen Cell License Agreement”) with the University of Technology Sydney
−Removed: (“UTS”) in Australia to use insulin-producing genetically engineered human liver cells developed by UTS to treat Type
−Removed: 1 diabetes and insulin-dependent Type 2 diabetes.
−Removed: The Company plans to develop a therapy for diabetes by encapsulating the Melligen
−Removed: cells using the Cell-in-a-Box ®
−Removed: encapsulation technology.
+Added: an exclusive, worldwide license agreement with the UTS (“Melligen Cell License Agreement”) in Australia to use insulin-producing
+Added: genetically engineered human liver cells developed by UTS to treat Type 1 diabetes and insulin-dependent Type 2 diabetes.
+Added: cells, named “Melligen”, were tested by UTS in mice and shown to produce insulin in direct proportion to the amount
+Added: of glucose in their surroundings.
+Added: In those studies, when Melligen cells were transplanted into immunosuppressed diabetic mice,
+Added: the blood glucose levels of the mice became normal.
+Added: In other words, the Melligen cells reportedly reversed the diabetic condition.
In December 2014, the Company acquired
from Austrianova an exclusive, worldwide license to use the Cell-in-a-Box ®
−Removed: technology in combination with genetically
−Removed: modified non-stem cell lines which are designed to activate cannabinoid prodrug molecules for development of therapies for diseases
−Removed: and their related symptoms using the Cell-in-a-Box ®
−Removed: technology and trademark (“Cannabis Licensing Agreement”).
−Removed: The Company paid Austrianova $2.0 million to secure this license.
+Added: Trademark and its Associated Technology
+Added: in combination with genetically modified non-stem cell lines which are designed to activate cannabinoid prodrug molecules for development
+Added: of therapies for diseases and their related symptoms (“Cannabis Licensing Agreement”).
+Added: This allows the Company to develop
+Added: a therapy to treat cancer and other diseases and symptoms through encapsulation of genetically modified cells designed to convert
+Added: cannabinoids to their active form using the Cell-in-a-Box ®
+Added: trademark and its associated technologies.
In July 2016, the Company entered into
−Removed: a Binding Memorandum of Understanding with Austrianova pursuant to which Austrianova will actively work to seek an investment partner
−Removed: or partners who will finance clinical trials and further develop products for the therapies for cancer, in exchange for which the
−Removed: Company, Austrianova and any future investment partner or partners will each receive a share of the net revenue from the sale of
−Removed: products in designated territories.
−Removed: Effective October 1, 2016, the Company
−Removed: and Bavarian Nordic/GSF amended the Bavarian Nordic/GSF License Agreement to:
−Removed: (i) include the right to import;
−Removed: (ii) reflect ownership
−Removed: and notification of improvements;
−Removed: (iii) clarify which provisions survive expiration or termination of the Bavarian Nordic/GSF License
−Removed: (iv) provide rights to Bio Blue Bird to the clinical data after expiration of the licensed patent rights;
−Removed: and (v) change
−Removed: the notice address and recipients of Bio Blue Bird.
−Removed: In August 2017, the Company entered into
−Removed: a Binding Term Sheet with SG Austria and Austrianova (“Binding Term Sheet”) pursuant to which the parties reached an
−Removed: agreement to amend certain provisions in the SG Austria APA, the Diabetes Licensing Agreement the Cannabis Licensing Agreement
−Removed: and the Vin-de-Bona Consulting Agreement (defined below).
−Removed: In May 2018 and pursuant to the Binding
−Removed: Term Sheet, the Company entered into agreements with SG Austria and Austrianova to amend certain provisions of the SG Austria APA,
−Removed: the Diabetes Licensing Agreement, the Cannabis Licensing Agreement and the Vin-de-Bona Consulting Agreement required by the Binding
−Removed: Term Sheet (“Binding Term Sheet Amendments”).
−Removed: The Binding Term Sheet Amendments provide that the Company’s obligation
−Removed: to make milestone payments to Austrianova are eliminated in their entirety under the Cannabis License Agreement and the Diabetes
−Removed: License Agreement, as amended.
−Removed: The Binding Term Sheet Amendments also provide that the Company’s obligation to make milestone
−Removed: payments to SG Austria pursuant to the SG Austria APA, as amended and clarified, is eliminated in its entirety.
−Removed: One of the Binding
−Removed: Term Sheet Amendments also provides that the scope of the Diabetes License Agreement is expanded to include all cell types and
−Removed: cell lines of any kind or description now or later identified, including, but not limited to, primary cells, mortal cells, immortal
−Removed: cells and stem cells at all stages of differentiation and from any source specifically designed to produce insulin for the treatment
+Added: a Binding Memorandum of Understanding with Austrianova (“Austrianova MOU”).
+Added: Pursuant to the Austrianova MOU, Austrianova
+Added: will actively work with the Company to seek an investment partner or partners who will finance clinical trials and further develop
+Added: products for the Company’s therapy for cancer, in exchange for which the Company, Austrianova and any future investment partner
+Added: will each receive a portion of the net revenue from the sale of cancer products.
+Added: In October 2016, Bavarian Nordic/GSF and
+Added: Bio Blue Bird further amended the Bavarian Nordic License Agreement (“Second Amendment to Bavarian Nordic/GSF License Agreement”)
+Added: (i) include the right to import in the scope of the license;
+Added: (ii) reflect ownership and notification of improvements;
+Added: (iii) clarify which provisions survive expiration or termination of the Bavarian Nordic License Agreement;
+Added: (iv) provide rights
+Added: to Bio Blue Bird to the clinical data after the expiration of the licensed patent rights;
+Added: and (v) change the notice address and
+Added: recipients of Bio Blue Bird.
+Added: In May 2018, the Company entered into a
+Added: series of binding term sheet amendments (“Binding Term Sheet Amendments”).
+Added: The Binding Term Sheet Amendments provide
+Added: that the Company’s obligation to make milestone payments to Austrianova is eliminated in their entirety under the:
+Added: License Agreement;
+Added: and (ii) the Diabetes License Agreement, as amended.
+Added: The Binding Term Sheet Amendments also provide that the
+Added: Company’s obligation to make milestone payments to SG Austria for therapies for cancer to be eliminated in their entirety.
+Added: In addition, the Binding Term Sheet Amendments also provides that the scope of the Diabetes License Agreement is expanded to include
+Added: all cell types and cell lines of any kind or description now or later identified, including, but not limited to, primary cells,
+Added: mortal cells, immortal cells and stem cells at all stages of differentiation and from any source specifically designed to produce
+Added: insulin for the treatment of diabetes.
In addition, one of the Binding Term Sheet
−Removed: Amendments provides that the Company has a 5-year right of first refusal from August 30, 2017 in the event that Austrianova chooses
−Removed: to sell, transfer or assign at any time during this period the Cell-in-a-Box ®
−Removed: tradename and its Associated Technologies;
−Removed: provided, however, that the Associated Technologies subject to the right of first refusal do not include Bac-in-a-Box ®
−Removed: which relates to encapsulation of probiotic bacteria and yeast for stomach acid protection and ambient storage.
−Removed: Also, for a period
−Removed: of one year from August 30, 2017 one of the Binding Term Sheet Amendments provides that Austrianova will not solicit, negotiate
−Removed: or entertain any inquiry regarding the potential acquisition of the Cell-in-a-Box ®
−Removed: encapsulation technology and
−Removed: its Associated Technologies.
+Added: Amendments provides that the Company will have a 5-year right of first refusal from August 30, 2017 in the event that Austrianova
+Added: chooses to sell, transfer or assign at any time during this period the Cell-in-a-Box ®
+Added: Trademark and Associated Technologies
+Added: , intellectual property, trade secrets and know-how, which includes the right to purchase any manufacturing facility used for the
+Added: Cell-in-a-Box ®
+Added: encapsulation process and a non-exclusive license to use the special cellulose sulfate utilized with
+Added: the Cell-in-a-Box ®
+Added: encapsulation process (collectively, “Associated Technologies”);
+Added: provided, however,
+Added: that the Associated Technologies subject to the right of first refusal do not include Bac-in-a-Box ®
+Added: Additionally,
+Added: for a period of one year from August 30, 2017 one of the Binding Term Sheet Amendments provides that Austrianova will not solicit,
+Added: negotiate or entertain any inquiry regarding the potential acquisition of the Cell-in-a-Box ®
+Added: and its Associated
+Added: Technologies.
The Binding Term Sheet Amendments further
−Removed: provide that the royalty payments on gross sales as specified in the SG Austria APA, the Cannabis License Agreement and the Diabetes
−Removed: License Agreement will be changed to 4%.
−Removed: They also provide that the royalty payments on amounts received by the Company from sublicensees’
−Removed: gross sales under the same agreements will be changed to 20% of the amount received by the Company’s sublicensees, provided,
−Removed: however , that in the event the amounts received by the Company from sublicensees is 4% or less of sublicensees’
−Removed: sales, Austrianova or SG Austria (as the case may be) will receive 50% of what the Company receives up to 2%.
−Removed: In addition, Austrianova
−Removed: or SG Austria (as the case may be) will receive 20% of any amount the Company receives over a 4% royalty payment from sublicensees.
−Removed: The Binding Term Sheet Amendments also
−Removed: provide that Austrianova will receive 50% of any other financial and non-financial consideration received from the Company’s
−Removed: sublicensees of the Cell-in-a-Box ®
+Added: provide that:
+Added: (i) the royalty payments on gross sales as specified in the SG Austria APA, the Cannabis License Agreement and the
+Added: Diabetes License Agreement are changed to 4%;
+Added: and (ii) the royalty payments on amounts received by the Company from sublicensees
+Added: on sublicensees’
+Added: gross sales under the same agreements are changed to 20% of the amount received from the sublicensees,
+Added: provided, however , that in the event the amounts received by the Company from sublicensees is 4% or less of sublicensees’
+Added: gross sales, Austrianova will receive 50% of what the Company receives (up to 2%) and then additionally 20% of any amount the
+Added: Company receives over that 4%.
+Added: One of the Binding Term Sheet Amendments
+Added: requires that the Company pay $900,000 to Austrianova ratably over a nine-month period in the amount of two $50,000 payments each
+Added: month during the nine-month period on the days of the month to be agreed upon between the parties, with a cure period of 20 calendar
+Added: days after receipt by the Company of written notice from Austrianova that the Company has failed to pay timely a monthly payment.
+Added: April 30, 2020, the $900,000 amount has been paid in full.
+Added: The Binding Term Sheet Amendments also provide that Austrianova receives
+Added: 50% of any other financial and non-financial consideration received from the Company’s sublicensees of the Cell-in-a-Box ®
NOTE 2 –
1 unchanged sentence
ACCOUNTING POLICIES
−Removed: The accompanying Condensed Consolidated
−Removed: Financial Statements as of January 31, 2020 and for the three and nine months ended January 31, 2020 and 2019 are unaudited.
−Removed: unaudited Condensed Consolidated Financial Statements have been prepared in accordance with U.S.
−Removed: generally accepted accounting
−Removed: principles (“U.S.
−Removed: GAAP”) for interim financial information and are presented in accordance with the requirements of
−Removed: Regulation S-X of the U.S.
−Removed: Securities and Exchange Commission (“Commission”) and with the instructions to this Quarterly
−Removed: Report on Form 10-Q (“Report”).
−Removed: Accordingly, they do not include all the information and Notes required by U.S.
−Removed: for complete Condensed Consolidated Financial Statements.
−Removed: In the opinion of management, all adjustments
−Removed: (consisting of normal recurring accruals) considered necessary for a fair presentation have been included.
−Removed: Operating results for
−Removed: the three and nine months ended January 31, 2020 are not necessarily indicative of the results that may be expected for the fiscal
−Removed: year ending April 30, 2020.
−Removed: The Condensed Consolidated Financial Statements should be read in conjunction with the audited Consolidated
−Removed: Financial Statements as of and for the fiscal year ended April 30, 2019 and the Notes thereto included in the Company’s Annual
−Removed: Report on Form 10-K for the period ended April 30, 2019 (“Form 10-K”) the Company filed with the Commission.
−Removed: The Condensed Consolidated Balance Sheet
−Removed: as of January 31, 2020 contained in this Report has been derived from the audited Consolidated Financial Statements as of April
−Removed: 30, 2019 but does not include all disclosures required by U.S.
Principles of Consolidation and Basis
8 unchanged sentences
(iv) Viridis Biotech, Inc.
−Removed: and are prepared in accordance with U.S.
−Removed: GAAP and the rules and regulations of the Commission.
−Removed: balances and transactions are eliminated.
−Removed: The Company’s 14.5% investment in SG Austria is presented on the cost method of
+Added: and are prepared in accordance with United States Generally Accepted Accounting Principles (“U.S.
+Added: GAAP”) and the rules and regulations of the United States Securities and Exchange Commission (“Commission”).
+Added: Intercompany balances and transactions are eliminated.
+Added: The Company’s 14.5% investment in SG Austria is presented on the cost
+Added: method of accounting.
Use of Estimates
9 unchanged sentences
Company’s Condensed Consolidated Financial Statements;
−Removed: Therefore, 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 consolidated
+Added: accordingly, it is possible that the actual results could differ from
+Added: these estimates and assumptions, which could have a material effect on the reported amounts of the Company’s condensed consolidated
financial position and results of operations.
5 unchanged sentences
The Company has elected to perform
−Removed: its annual analysis at the end of its fiscal year.
+Added: its annual analysis at the end of its reporting year.
The Company’s intangible assets are
−Removed: licensing agreements related to the use the Cell-in-a-Box ®
−Removed: Trademark and Associated Technologies for the treatment
−Removed: of cancer of $1,549,427 and the Diabetes Licensing Agreement related to the use of the Cell-in-a-Box ®
−Removed: and Associated Technologies for the treatment of diabetes of $2,000,000 for an aggregate total of $3,549,427.
+Added: licensing agreements related to the Cell-in-a-Box ®
+Added: technology for $1,549,427 and the diabetes license for $2,000,000
+Added: for an aggregate total of $3,549,427.
These intangible assets have an indefinite
1 unchanged sentence
The Company concluded that there was no
−Removed: impairment of the carrying value of the intangibles for the nine months ended January 31, 2020 and 2019.
+Added: impairment of the carrying value of the intangibles for the three months ended July 31, 2020 and 2019.
Impairment of Long-Lived Assets
4 unchanged sentences
No impairment was identified or
−Removed: recorded during the nine months ended January 31, 2020 and 2019.
+Added: recorded during the three months ended July 31, 2020 and 2019.
Fair Value of Financial Instruments
16 unchanged sentences
Unobservable inputs in which there is little or no market data, which require the reporting entity to develop its own assumptions.
−Removed: The Company follows ASC subtopic 820-10,
−Removed: Fair Value Measurements and Disclosures and ASC subtopic 825-10, Financial Instruments, which permit entities to choose to measure
−Removed: many financial instruments and certain other items at fair value.
−Removed: The carrying value of cash, accounts payable and accrued expenses,
−Removed: as reflected in the condensed consolidated balance sheets, approximate fair value because of the short-term maturity of these instruments.
Deferred taxes are calculated using the
27 unchanged sentences
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.
−Removed: When this occurs,
−Removed: the issue is resolved with the taxing authority or the statute of limitations expires.
+Added: Step one, recognition, requires evaluation of
+Added: the tax position to determine if based solely on technical merits it is more likely than not to be sustained upon examination.
+Added: Step two, measurement, is addressed only if a position is more likely than not to be sustained.
+Added: In step two, the tax benefit is
+Added: measured as the largest amount of benefit, determined on a cumulative probability basis, which is more likely than not to be realized
+Added: upon ultimate settlement with tax authorities.
+Added: If a position does not meet the more likely than not threshold for recognition
+Added: in step one, no benefit is recorded until the first subsequent period in which the more likely than not standard is met, the issue
+Added: is resolved with the taxing authority or the statute of limitations expires.
Positions previously recognized are derecognized
4 unchanged sentences
could differ materially from these estimates.
−Removed: The Company maintains a full valuation
−Removed: allowance on its U.S.
+Added: On March 27, 2020, Congress enacted the
+Added: “Coronavirus Aid, Relief and Economic Security ("CARES") Act”
+Added: to provide certain relief as a result of the
+Added: 2019 Coronavirus pandemic.
+Added: The Company maintains a full valuation allowance on its U.S.
net deferred tax assets.
−Removed: Deferred tax asset remeasurement (tax expense) was offset by a net decrease in valuation
−Removed: allowance, that resulted in no impact on the Company's income tax expense.
+Added: Deferred tax asset
+Added: remeasurement (tax expense) was offset by a net decrease in valuation allowance, that resulted in no impact on the Company's income
+Added: Therefore, the Company does not expect the provisions in the CARES Act will impact the Company’s Condensed Consolidated
+Added: Financial Statements.
Research and Development
2 unchanged sentences
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, 2020 were $113,296 and $203,566, respectively, and for the three and nine months ended January 31, 2019
−Removed: were $59,144 and $442,039, respectively.
+Added: technologies, including licenses, that are utilized in research and development and that have no alternative future use are expensed
+Added: when incurred.
+Added: Technology developed for use in the Company’s product candidates is expensed as incurred until technological
+Added: feasibility has been established.
+Added: R&D expenses for the three months ended
+Added: July 31, 2020 and 2019 were $270,574 and $72,330, respectively.
Stock-Based Compensation
16 unchanged sentences
Company maintains most of its cash balance at a financial institution located in California.
−Removed: The Company’s account at this
−Removed: institution is insured by the Federal Deposit Insurance Corporation up to $250,000.
−Removed: Uninsured balances aggregated approximately
−Removed: $0 and $127,000 at January 31, 2020 and April 30, 2019, respectively.
−Removed: The Company has not experienced any losses from this account.
−Removed: Management believes it is not exposed to any significant credit risk on cash.
+Added: Accounts at this institution are
+Added: insured by the Federal Deposit Insurance Corporation up to $250,000.
+Added: Uninsured balances aggregated approximately $1,887,000 and
+Added: $618,000 at July 31, 2020 and April 30, 2020, respectively.
+Added: The Company has not experienced any losses in such accounts.
+Added: believes it is not exposed to any significant credit risk on cash.
Foreign Currency Translation
3 unchanged sentences
Currency Matters .
−Removed: All assets and liabilities of the Company’s foreign subsidiaries are translated at quarter-end exchange
+Added: All assets and liabilities of the Company’s foreign subsidiaries are translated at period-end exchange
rates, while revenue and expenses are translated at average exchange rates prevailing during the period.
1 unchanged sentence
currency translation fluctuations are excluded from net loss and are included in other comprehensive income.
−Removed: Gains and losses on
−Removed: short-term intercompany foreign currency transactions are recognized as incurred.
+Added: Gains and losses
+Added: on short-term intercompany foreign currency transactions are recognized as incurred.
Going Concern
3 unchanged sentences
raise substantial doubt about the Company's ability to do so.
−Removed: The condensed consolidated financial statements do not include any
−Removed: adjustments to reflect the possible future effects on the recoverability and classification of assets or the amounts and classifications
−Removed: of liabilities that may result should the Company be unable to continue as a going concern.
−Removed: As of January 31, 2020, the Company
−Removed: had an accumulated deficit of $103,107,876 and incurred a net loss for the nine months ended January 31, 2020 of $3,076,505.
−Removed: Company requires substantial additional capital to finance its planned business operations and expects to incur operating losses
−Removed: in future periods due to the expenses related to the Company’s core businesses.
−Removed: The Company has not realized any revenue
−Removed: since it commenced doing business in the biotechnology sector, and there can be no assurance that it will be successful in generating
−Removed: revenues in the future in this sector.
−Removed: For the nine months ended January 31, 2020,
+Added: As of July 31, 2020, the Company has an accumulated deficit
+Added: of $104,742,203 and incurred a net loss for three months ended July 31, 2020 of $883,944.
+Added: The Company requires substantial additional
+Added: capital to finance its planned business operations and expects to incur operating losses in future periods due to the expenses
+Added: related to the Company’s core businesses.
+Added: The Company has not realized any revenue since it commenced doing business in the
+Added: biotechnology sector, and there can be no assurance that it will be successful in generating revenues in the future in this sector.
+Added: The Condensed Consolidated Financial Statements do not include any adjustments to reflect the possible future effects on the recoverability
+Added: and classification of assets or the amounts and classifications of liabilities that may result should the Company be unable to
+Added: continue as a going concern.
+Added: For the three months ended July 31, 2020,
funding was provided by investors to maintain and expand the Company’s operations.
−Removed: Sales of the Common Stock were made under
−Removed: the Registration Statement on Form S-3 filed on September 13, 2017 (“S-3”) allowing for offerings of up to $50 million
−Removed: in transactions that are deemed to be “at the market offerings”
−Removed: as defined in Rule 415 under the Securities Act of
−Removed: 1933, as amended (“Securities Act”) or transactions structured as a public offering of a distinct block or blocks of
−Removed: shares (“Block Trades”) of Common Stock.
−Removed: During the nine-month period ended January 31, 2020, the Company continued
−Removed: to acquire funds through the Company’s S-3 pursuant to which the placement agent sells shares of Common Stock in Block Trades
−Removed: in a program which is structured to provide up to $25 million to the Company less certain commissions pursuant to the S-3.
+Added: Sales of the Company’s common stock
+Added: were made under an operative Form S-3 (“S-3”) allowing for offerings of up to $50 million dollars in transactions that
+Added: are deemed to be “at the market offerings”
+Added: as defined in Rule 415 under the Securities Act or transactions structured
+Added: as a public offering of a distinct block or blocks of the shares of the Company’s common stock.
+Added: During the three months ended
+Added: July 31, 2020, the Company continued to acquire funds through the Company’s S-3 pursuant to which the placement agent sells
+Added: shares of common stock “at-the-market”
+Added: in a program which is structured to provide up to $25 million to the Company
+Added: less certain commissions pursuant to the S-3.
+Added: From May 1, 2020 through July 31, 2020 the Company raised capital of approximately
+Added: $1.9 million in Block Trade transactions and “at-the-market”
+Added: transactions.
+Added: From August 1, 2020 through August 12,
+Added: 2020, the Company raised capital of approximately $2.8 million in Block Trades net of commissions.
On August 13, 2020, the Company no longer
met the eligibility requirements to use the S-3 to raise capital, and the Company ceased to use the S-3 to raise capital after
−Removed: In late January 2020, the Company became eligible to use the S-3.
−Removed: From May 1, 2019 through August 12, 2019
−Removed: the Company raised capital of approximately $884,000 in Block Trade transactions net of commissions.
−Removed: During the quarter ended January
−Removed: 31, 2020, the Company raised $450,000 through the sale of unregistered shares of its Common Stock in private placement transactions.
−Removed: Subsequent to January 31, 2020, the Company raised additional capital in the amount of $65,000 through the sale of unregistered
−Removed: shares of its Common Stock in private placement transactions and $186,000 net of commissions, in Block Trades pursuant to the S-3.
−Removed: The Company plans to continue to sell registered
−Removed: securities using the S-3 to raise capital to fund operations and R&D expenses until it files its Annual Report on Form 10-K
−Removed: for the fiscal year ended April 30, 2020 with the Commission, at which time it believes the S-3 will no longer be available to
−Removed: use to raise capital.
+Added: Management determined that its plans to
+Added: raise additional capital alleviate substantial doubt about the Company’s ability to continue as a going concern.
+Added: believes the cash on hand, the potential sales of unregistered shares of its common stock and any public offerings of common stock
+Added: in which the Company may engage in will provide sufficient capital to meet the Company’s capital requirements and to fund
+Added: the Company’s operations through September 30, 2021.
Recent Accounting Pronouncements
−Removed: On May 1, 2019, the Company adopted Accounting
−Removed: Standards Update (“ASU”) No.
−Removed: 2016-02, “Leases (Topic 842),”
−Removed: which requires the recognition of right-of-use
−Removed: (“ROU”) assets and lease liabilities on the consolidated balance sheet.
−Removed: This ASU retains a distinction between finance
−Removed: leases and operating leases, and the classification criteria for distinguishing between finance leases and operating leases are
−Removed: substantially similar to the classification criteria for distinguishing between capital leases and operating leases in the current
−Removed: accounting literature.
−Removed: Under the standard, disclosures are required to meet the objective of enabling users of financial statements
−Removed: to assess the amount, timing, and uncertainty of cash flows arising from leases.
−Removed: The Company elected the available practical expedients
−Removed: Adoption of the new standard resulted in an immaterial amount of total lease liabilities and ROU assets of as of May
−Removed: The Company does not anticipate any material
−Removed: impact on its condensed consolidated financial statements upon the adoption of the following accounting pronouncements issued during
−Removed: 2018 and 2019:
−Removed: (i) ASU 2018-19, ASC Topic 326:
−Removed: Codification Improvements to Financial Instruments ;
−Removed: and (ii) ASU No.
−Removed: Financial Instruments - Credit Losses (Topic 326):
−Removed: Measurement of Credit Losses on Financial Instruments .
−Removed: 2019-12, Simplifying
−Removed: the Accounting for Income Taxes ("ASU 2019-12"), was issued in December 2019.
−Removed: Under ASU 2019-12, the accounting for
−Removed: income taxes is simplified by eliminating certain exceptions and implementing additional requirements which result in a more consistent
−Removed: application of ASC 740.
−Removed: The Company is currently in the process of evaluating the impact of adopting ASU 2019-12 in 2021, but it
−Removed: does not expect it to have a material impact on our condensed consolidated financial statements.
+Added: 2016-13, Financial Instruments
+Added: - Credit Losses (Topic 326):
+Added: Measurement of Credit Losses on Financial Instruments ("ASU 2016-13"), was issued in
+Added: Under ASU 2016-13, existing guidance on reporting credit losses for trade and other receivables and available for sale
+Added: debt securities will be replaced with a new forward-looking "expected loss"
+Added: model that generally will result in the earlier
+Added: recognition of allowances for losses.
+Added: The Company’s adoption of ASU 2016-13 during the quarter ended July 31, 2020 did not
+Added: result in an impact on the Company’s Condensed Consolidated Financial Statements.
+Added: 2019-12, Simplifying the Accounting
+Added: for Income Taxes ("ASU 2019-12"), was issued in December 2019.
+Added: Under ASU 2019-12, the accounting for income taxes
+Added: is simplified by eliminating certain exceptions and implementing additional requirements which result in a more consistent application
+Added: The Company is currently in the process of evaluating the impact of adopting ASU 2019-12 in 2021, but it does not expect
+Added: it to have a material impact on the Company’s Condensed Consolidated Financial Statements.
NOTE 3 –
ACCRUED EXPENSES
−Removed: Accrued expenses at January 31, 2020 and
−Removed: April 30, 2019 are summarized below:
−Removed: January 31, 2020
+Added: Accrued expenses at July 31, 2020 and April
+Added: 30, 2020 are summarized below:
+Added: July 31, 2020
April 30, 2020
Payroll related costs
−Removed: Share issuance compensation
+Added: Director and Officer insurance financing
+Added: The Company financed the Director and
+Added: Officer insurance policy.
+Added: The term of the policy is from March 8, 2020 through March 8, 2021.
+Added: The financing agreement has an interest
+Added: rate of 4.25% per annum and requires eight monthly payments of $12,806.
+Added: The unpaid balances as of July 31, 2020 and April 30,
+Added: 2020 are $75,908 and $113,245, respectively, are included in accrued expenses.
NOTE 4 –
+Added: SMALL BUSINESS ADMINISTRATION
+Added: PAYCHECK PROTECTION PROGRAM
+Added: On March 27, 2020, the CARES Act was enacted
+Added: to provide financial aid to family and businesses impacted by the COVID-19 pandemic.
+Added: The Company participated in the CARES
+Added: Act, and on April 15, 2020, the Company entered into a note payable with a bank under the Small Business Administration (“SBA”)
+Added: Paycheck Protection Program (“PPP loan”) in the amount of $75,200.
+Added: This loan payable matures on April 15, 2022 with
+Added: a fixed interest rate of 1% per annum with interest deferred for six months.
+Added: The PPP loan has an initial term of two years, is
+Added: unsecured and guaranteed by the SBA.
+Added: Under the terms of the PPP loan, the Company may apply for forgiveness of the amount due on
+Added: the PPP loan.
+Added: The Company used the proceeds from the PPP loan for qualifying expenses as defined in the PPP.
+Added: The Company intends
+Added: to apply for forgiveness of the PPP loan in accordance with the terms of the CARES Act.
+Added: However, the Company cannot assure at this
+Added: time that the PPP loan will be forgiven partially or in full.
+Added: If the loan is not forgiven based on the PPP guidelines to be issued
+Added: by the SBA, as defined, then, the monthly payment amount will be $4,229 beginning on October 15, 2020 through April 15, 2022.
+Added: PPP loan balance as of July 31, 2020 and April 30, 2020 was $75,200.
+Added: NOTE 5 –
COMMON STOCK TRANSACTIONS
−Removed: A summary of the Common Stock transactions
−Removed: and related weighted average grant date fair value information for the nine months ended January 31, 2020 and 2019 is set forth
−Removed: In July 2017, the Company issued 4,200,000
−Removed: shares of restricted Common Stock to three consultants pursuant to consulting agreements.
−Removed: The terms of two of the agreements were
−Removed: for twelve months and one agreement was for eighteen months.
−Removed: The shares vest monthly over a twelve-month to eighteen-month period
−Removed: and were subject to the consultants providing services under their respective agreements with the Company.
−Removed: The Company recorded
−Removed: a non-cash consulting expense in the amount of $0 and $0 for the three and nine months ended January 31, 2020, respectively, and
−Removed: $11,200 and $73,800 for the three and nine months ended January 31, 2019, respectively.
−Removed: There were no unvested shares remaining
−Removed: related to such consulting agreements as of January 31, 2020 and 2019, respectively.
−Removed: During the nine months ended January 31,
−Removed: 2019, the Company issued 1,950,000 shares of restricted Common Stock to two consultants pursuant to consulting agreements.
−Removed: terms of these two consulting agreements were for twelve months.
−Removed: The shares vest monthly over a twelve-month period and are subject
−Removed: to the consultants providing services under their respective consulting agreement.
−Removed: An additional agreement with one of the consultants
−Removed: required 500,000 shares vest upon issuance.
−Removed: The Company recorded a non-cash consulting expense in the amount of $0 and $12,816
−Removed: for the three and nine months ended January 31, 2020, respectively, and $24,230 and $67,084 for the three and nine months ended
−Removed: January 31, 2019, respectively.
−Removed: There were zero and 562,500 unvested shares of Common Stock remaining related to these consulting
−Removed: agreements as of January 31, 2020 and 2019, respectively.
−Removed: In April 2019, two consultants were issued
−Removed: 2,500,000 shares of restricted Common Stock pursuant to their respective consulting agreement.
−Removed: The term of the agreements is for
−Removed: twelve months which covered prior and current periods.
−Removed: The shares vest monthly over a twelve-month period and are subject to the
−Removed: consultant providing services under their respective consulting agreement.
−Removed: The Company recorded a non-cash consulting expense in
−Removed: the amount of $0 and $11,910 for the three and nine months ended January 31, 2020.
−Removed: There were zero unvested shares as of January
−Removed: During the nine months ended January 31,
−Removed: 2020, the four independent directors of the Company’s Board of Directors (“Board”) were issued 2,000,000 shares
−Removed: of restricted Common Stock pursuant to their respective Director Letter Agreement (“DLA”) with the Company.
−Removed: to their services for the prior year.
−Removed: The terms of each DLA is for twelve months.
−Removed: The shares vest on the directors’
−Removed: date of their respective DLA.
−Removed: The Company recorded a non-cash expense of $0 and $19,212 for the three and nine months ended January
−Removed: 31, 2020, respectively.
−Removed: There were zero unvested shares of Common Stock remaining related to these DLAs as of January 31, 2020.
−Removed: During the nine months ended January 31,
−Removed: 2020, a consultant was issued 500,000 shares of restricted Common Stock pursuant to his consulting agreement with the Company.
−Removed: The term of the consulting agreement is for twelve months which covered prior and current periods.
+Added: A summary of the Company’s compensatory
+Added: stock activity and related weighted average grant date fair value information for the three months ended July 31, 2020 and 2019
+Added: is as follows:
+Added: During the three months ended July 31,
+Added: 2019, the Company issued 2,000,000 shares of common stock to four non-employee members of the Company’s Board of Directors
+Added: (“Board”) pursuant to Director Letter Agreements (“DLAs”) with the Company for services relating to the
+Added: The shares vested upon issuance and the Company recorded a non-cash expense of $0 and $13,804 for the three months
+Added: ended July 31, 2020 and 2019, respectively.
+Added: Effective July 1, 2018, the Company issued
+Added: 1,200,000 shares of common stock to a consultant.
+Added: The term of the agreement is for twelve months.
The shares vest monthly over
−Removed: a twelve-month period and are subject to the consultant providing services under his consulting agreement.
−Removed: The Company recorded
−Removed: a non-cash consulting expense in the amount of $0 and $17,350 for the three and nine months ended January 31, 2020, respectively.
−Removed: In April 2019, the Company awarded 6,600,000
−Removed: shares of restricted Common Stock to officers as part of their respective executive compensation agreement for 2019.
−Removed: vest monthly over a twelve-month period and are subject to them continuing service under their respective executive compensation
−Removed: During the three and nine months ended January 31, 2020, the Company recorded a non-cash compensation expense in the
−Removed: amount of $69,438 and $278,891, respectively.
−Removed: There were zero unvested shares as of January 31, 2020.
−Removed: During the nine months ended January 31,
−Removed: 2020, four independent directors of the Board were issued 2,000,000 shares of restricted Common Stock pursuant to their respective
−Removed: DLA with the Company.
−Removed: Each share issuance under a DLA covers a twelve-month period.
−Removed: The shares vest upon the appointment of a director
−Removed: pursuant to a DLA.
−Removed: The DLA is automatically renewed and a new grant of shares of Common Stock occurs upon on the anniversary date
−Removed: The Company recorded a non-cash expense of $18,998 and $46,433 for the three and nine months ended January 31, 2020,
−Removed: respectively.
−Removed: There were zero unvested shares remaining related to a DLA as of January 31, 2020.
−Removed: During the nine months ended January 31,
−Removed: 2020, a consultant was issued 2,000,000 shares of restricted Common Stock pursuant to his services as the Chairman of the Company’s
−Removed: Medical and Scientific Advisory Board over a four-year period.
−Removed: This share issuance covered prior and current periods.
−Removed: vest upon issuance are subject to the consultant providing services to the Company.
+Added: a twelve-month period and are subject to the consultant providing services under the agreement.
+Added: The Company recorded a non-cash
+Added: consulting expense in the amount of $0 and $12,816 for the three months ended July 31, 2020 and 2019, respectively.
+Added: zero unvested shares as of July 31, 2020 and 2019, respectively.
+Added: During the month of April 2019, two consultants
+Added: were issued 2,500,000 shares of common stock pursuant to their consulting agreements.
+Added: The term of the agreements is for twelve
+Added: months which covered prior and current periods.
+Added: The shares vest monthly over a twelve-month period and are subject to the consultant
+Added: providing services under their respective consulting agreements.
+Added: The Company recorded a non-cash consulting expense in the amount
+Added: of $0 and $7,209 for the three months ended July 31, 2020 and 2019, respectively.
+Added: There were zero and 83,333 unvested shares as
+Added: of July 31, 2020 and 2019, respectively.
+Added: During the three months ended July 31,
+Added: 2019, a consultant was owed 500,000 shares of common stock pursuant to his consulting agreement with the Company.
+Added: The term of the
+Added: consulting agreement is for twelve months which covered prior and current periods.
+Added: The shares vest monthly over a twelve-month
+Added: period and are subject to the consultant providing services under his consulting agreement.
The Company recorded a non-cash consulting
−Removed: expense in the amount of $0 and $11,851 for the three and nine months ended January 31, 2020, respectively.
−Removed: There were zero unvested
−Removed: shares remaining related to his compensation agreements as of January 31, 2020.
−Removed: During the nine months ended January 31,
−Removed: 2020, five consultants were issued 2,200,000 shares of restricted Common Stock pursuant to their respective consulting agreement
+Added: expense in the amount of $0 and $3,306 for the three months ended July 31, 2020 and 2019, respectively.
+Added: As of July 31, 2020 and
+Added: 2019, zero and 500,000 shares remained unissued, respectively.
+Added: The Company awarded 6,600,000 shares of
+Added: common stock to officers as part of their compensation agreements for 2019.
+Added: These shares vest monthly over a twelve-month period
+Added: and are subject to them continuing service under the agreements.
+Added: During the three months ended July 31, 2020 and 2019, the Company
+Added: recorded a non-cash compensation expense in the amount of $0 and $104,726, respectively.
+Added: There were zero and 2,750,000 unvested
+Added: shares as of July 31, 2020 and 2019, respectively.
+Added: During the three months ended July 31,
+Added: 2019, three non-employee members of the Board were issued 1,500,000 shares of common stock pursuant to their DLAs with the Company.
+Added: The shares were fully vested upon issuance.
+Added: The Company recorded a non-cash expense of $7,356 and $11,642 for the three months
+Added: ended July 31, 2020 and 2019, respectively.
+Added: There were zero unvested shares of Common Stock remaining related to these DLAs as
+Added: of July 31, 2020 and 2019.
+Added: During the three months ended July 31,
+Added: 2019, a consultant was issued 2,000,000 shares of common stock in respect of his services as the Chairman of the Company’s
+Added: Medical and Scientific Advisory Board over a four-year period with their vesting subject to the consultant providing services to
+Added: The Company recorded a non-cash consulting expense in the amount of $0 and $7,150 for the three months ended July
+Added: 31, 2020 and 2019, respectively.
+Added: There were zero unvested shares remaining related to these compensation agreements as of July
+Added: 31, 2020 and 2019.
+Added: During the three months ended July 31,
+Added: 2020, three non-employee members of the Board were issued 1,500,000 shares of Common Stock pursuant to their DLAs in respect of
+Added: their service during that year.
+Added: The shares were fully vested upon issuance.
+Added: The Company recorded a non-cash expense of $7,029 and
+Added: $0 for the three months ended July 31, 2020 and 2019, respectively.
+Added: There were zero unvested shares remaining related to a DLA
+Added: as of July 31, 2020.
+Added: During the three months ended July 31,
+Added: 2020, four consultants were issued 1,000,000 shares of restricted Common Stock pursuant to their respective consulting agreement
with the Company.
1 unchanged sentence
The shares vest monthly over a twelve-month period and are
−Removed: subject to the consultant providing services under the consultant’s respective consulting agreement.
+Added: subject to the consultants providing services under the consultant’s respective consulting agreement.
The Company recorded
−Removed: a non-cash consulting expense in the amount of $26,092 and $46,895 for the three and nine months ended January 31, 2020, respectively.
−Removed: There were 750,000 unvested shares remaining related to these consulting agreements as of January 31, 2020.
−Removed: During the nine months ended January 31,
−Removed: 2020, a consultant was issued 500,000 shares of restricted Common Stock pursuant to his services as the Company’s Chairman
−Removed: of its Medical and Scientific Advisory Board over a twelve-month period.
−Removed: The shares vest upon issuance.
−Removed: The Company recorded a
−Removed: non-cash consulting expense in the amount of $4,600 and $6,133 for the three and nine months ended January 31, 2020, respectively.
+Added: a non-cash consulting expense in the amount of $4,199 and $0 for the three months ended July 31, 2020 and 2019, respectively.
+Added: were 750,000 unvested shares remaining related to these consulting agreements as of July 31, 2020.
In January 2020, the Company awarded 6,600,000
−Removed: shares of restricted Common Stock to officers as part of their executive compensation agreements for 2020.
−Removed: These shares vest monthly
−Removed: over a twelve-month period and are subject to them continuing service under their respective executive compensation agreement.
−Removed: During the three and nine months ended January 31, 2020, the Company recorded a non-cash compensation expense in the amount of
−Removed: $30,800 and $30,800, respectively.
−Removed: There were 6,050,000 unvested shares remaining related to the executive compensation agreements
−Removed: as of January 31, 2020.
−Removed: During the nine months ended January 31,
−Removed: 2020, the Company entered into three stock subscription agreements resulting in the sale and issuance of ninety million (90 million)
−Removed: shares of restricted Common Stock.
−Removed: The Company received $450,000 from the sale of these shares.
−Removed: All shares described above were issued
−Removed: without 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: 2020 and 2019, the Company sold and issued approximately 136.7 and 111.7 million shares of registered Common Stock, respectively,
−Removed: at prices ranging from approximately $0.01 to $0.03 per share as Block Trades pursuant to the Company’s S-3.
−Removed: Net of underwriting
−Removed: discounts, legal, accounting and other offering expenses, the Company received net proceeds of approximately $884,000 and $1.9
−Removed: million from the sale of these shares for the nine months ended January 31, 2020 and 2019, respectively.
−Removed: On October 30, 2019, the Company issued
−Removed: one share of its Series A Preferred Stock to its Chief Executive Officer as described in detail in Note 11 –
−Removed: Preferred Stock.
−Removed: On October 31, 2019, the Board passed a resolution recommending to shareholders that they approve the amendment of the Company’s
−Removed: articles of incorporation to increase the number of authorized shares of the Company’s common stock by 1,000,000,000 from
−Removed: 1,490,000,000 to 2,490,000,000 shares.
−Removed: Subsequently, on October 31, 2019, by a written consent executed by holders of a majority
−Removed: of the voting power of the Company’s outstanding stock, the Company’s stockholders approved such an amendment.
−Removed: October 31, 2019 such amendment was filed with the Secretary of State of the State of Nevada.
+Added: shares of common stock to officers as part of their compensation agreements.
+Added: These shares vest monthly over a twelve-month period
+Added: and are subject to them continuing service under the agreements.
+Added: During the three months ended July 31, 2020, the Company recorded
+Added: a non-cash compensation expense in the amount of $67,320.
+Added: There were 2,750,000 unvested shares as of July 31, 2020.
+Added: All shares listed above were issued without
+Added: registration under the Securities Act in reliance upon the exemption afforded by Section 4(a)(2) of the Securities Act.
+Added: During the three months ended July 31,
+Added: 2020 and 2019, the Company sold and issued approximately 234 million and 66.7 million shares of common stock, respectively, at
+Added: prices ranging from approximately $0.01 to $0.03 per share pursuant to the Company’s S-3.
+Added: Net of underwriting discounts,
+Added: legal, accounting and other offering expenses, the Company received net proceeds of approximately $1,857,000 and $558,000 from
+Added: the sale of these shares for the three months ended July 31, 2020 and 2019, respectively.
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,
+Added: restricted stock activity and related weighted average grant date fair value information for the three months ended July 31, 2020
are as follows:
−Removed: Unvested, April 30, 2019
−Removed: Unvested, January 31, 2020
+Added: Unvested, at April 30, 2020
+Added: Unvested, at July 31, 2020
NOTE 6 –
1 unchanged sentence
Stock Options
−Removed: As of January 31, 2020, the Company had
−Removed: 94,650,000 outstanding stock options to its directors and officers (collectively, “Employee Options”) and consultants
−Removed: (collectively, “Non-Employee Options”).
−Removed: During the nine months ended January 31,
−Removed: 2020 and 2019, the Company granted 11,000,000 and zero Employee Options, respectively.
−Removed: During the nine months ended January 31,
−Removed: 2020, 25,000,000 options expired.
+Added: As of July 31, 2020, the Company had 68,700,000
+Added: outstanding stock options to its directors and officers (collectively, “Employee Options”) and consultants (“Non-Employee
+Added: Options”).
+Added: During the three months ended July 31,
+Added: 2020 and 2019, the Company granted 1,500,000 and 1,500,000 Employee Options, respectively.
The fair value of the Employee Options
at the date of grant was estimated using the Black-Scholes-Merton option-pricing model, based on the following weighted average
−Removed: Nine Months Ended January 31,
+Added: Three Months Ended July 31,
Risk-free interest rate
Expected volatility
−Removed: Expected lives (years)
+Added: Expected term (years)
Expected dividend yield
The Company’s computation of expected
−Removed: volatility is based on the historical daily volatility of publicly traded Common Stock.
+Added: volatility is based on the historical daily volatility of its publicly traded stock.
For stock option grants issued during the
−Removed: nine months ended January 31, 2020 and 2019, the Company used a calculated volatility for each grant.
+Added: three months ended July 31, 2020 and 2019, the Company used a calculated volatility for each grant.
The Company lacks adequate
−Removed: information about potential exercise behavior and has determined the expected term assumption under the simplified method provided
+Added: information about the exercise behavior now and has determined the expected term assumption under the simplified method provided
for under ASC 718, which averages the contractual term of the Company’s stock options of five years with the average vesting
5 unchanged sentences
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: 2020 and 2019, the Company granted 1,200,000 and 1,200,000 Non-Employee Options, respectively.
−Removed: During the three months ended January
−Removed: 31, 2020 and 2019, the Company granted zero and zero Non-Employee Options, respectively.
−Removed: Non-Employee Option grants that do not
−Removed: vest immediately upon grant are recorded as an expense over the vesting period.
−Removed: The value of the options was determined as of the
−Removed: grant date using the Black-Scholes-Merton option-pricing model and compensation expense is being recognized over the service period.
+Added: During the three months ended July 31,
+Added: 2020 and 2019, the Company granted no Non-Employee Options.
A summary of the Company’s stock
−Removed: option activity and related information for the nine months ended January 31, 2020 are shown below:
+Added: option activity and related information for the three months ended July 31, 2020 is shown below:
Exercise Price
Outstanding, April 30, 2020
−Removed: Outstanding, January 31, 2020
−Removed: Exercisable, January 31, 2020
+Added: Outstanding, July 31, 2020
+Added: Exercisable, July 31, 2020
Vested and expected to vest
A summary of the activity for unvested
−Removed: stock options during the nine months ended January 31, 2020 is as follows:
+Added: stock options during the three months ended July 31, 2020 is as follows:
Unvested, April 30, 2020
−Removed: Unvested, January 31, 2020
+Added: Unvested, July 31, 2020
The Company recorded $72,317 and $116,914
of stock-based compensation related to the issuance of Employee Options to certain officers and directors in exchange for services
−Removed: during the three months ended January 31, 2020 and 2019, respectively, and $284,934 and $204,619 during the nine months ended January
+Added: during the three months ended July 31, 2020 and 2019, respectively.
+Added: At July 31, 2020, there remained $88,526 of unrecognized compensation
+Added: expense related to unvested Employee Options granted to officers and directors, to be recognized as expense over a weighted-average
+Added: period of the remaining five months in the calendar year.
+Added: The unvested options vest at 750,000 shares per month and are expected
+Added: to be fully vested on December 31, 2020.
+Added: The Company recorded $0 and $9,411 of stock-based
+Added: compensation related to the issuance of Non-Employee Options in exchange for services during the three months ended July 31, 2020
and 2019, respectively.
−Removed: At January 31, 2020, there remained $194,758 of unrecognized compensation expense related to unvested
−Removed: Employee Options granted to officers and directors, to be recognized as expense over a weighted-average period of the remaining
−Removed: eleven months in the calendar year.
−Removed: The unvested options vest at 750,000 shares per month and are expected to be fully vested on
−Removed: December 31, 2020.
−Removed: The Company recorded $10,411 and $21,331
−Removed: of stock-based compensation related to the issuance of Non-Employee Options in exchange for services during the three months ended
−Removed: January 31, 2020 and 2019, respectively, and $24,237 and $78,054 during the nine months ended January 31, 2020 and 2019, respectively.
−Removed: At January 31, 2020, there remained $17,089 of unrecognized compensation expense related to unvested Non-Employee Options granted
−Removed: to consultants, to be recognized as expense over a weighted-average period of the remaining five months.
−Removed: The unvested Non-Employee
−Removed: Options vest at 100,000 shares per month and are expected to be fully vested on June 30, 2020.
−Removed: The following table summarizes ranges of
−Removed: outstanding stock options by exercise price at January 31, 2020:
+Added: There were no unvested Non-Employee Options on July 31, 2020.
+Added: The following table summarizes the outstanding
+Added: stock options by exercise price at July 31, 2020:
Exercise Price
Contractual Life
+Added: of Outstanding
+Added: Options (years)
Weighted Average
2 unchanged sentences
The aggregate intrinsic value of outstanding
−Removed: options as of January 31, 2020 was $125,970.
−Removed: This represents options whose exercise price was less than the closing fair market
−Removed: value of Common Stock on January 31, 2020 of approximately $0.056 per share.
+Added: options as of July 31, 2020 was zero.
+Added: This represents options whose exercise price was less than the closing fair market value
+Added: of the Company’s common stock on July 31, 2020 of approximately $0.014 per share.
The warrants issued by the Company are
3 unchanged sentences
of services rendered by non-employees, the Company recognizes consulting expense in accordance with the requirements of ASC 505.
−Removed: The Company issued a Common Stock Purchase
−Removed: Warrant (“May 2018 Warrant”) to Aeon Capital, Inc.
−Removed: (“Aeon”) dated May 30, 2018 for a Block Trade pursuant
−Removed: to the Company’s engagement agreement with Aeon dated February 22, 2018 (“Engagement Agreement”).
−Removed: Warrant provides Aeon the right to purchase 1,388,889 shares of restricted Common Stock based upon this Block Trade.
−Removed: classified the May 2018 Warrant as equity.
−Removed: The May 2018 Warrant has a term of five years with an exercise price of approximately
−Removed: $0.02 per warrant share.
−Removed: Using the Black-Scholes-Merton option pricing model, the Company determined the aggregate value of the
−Removed: May 2018 Warrant to be approximately $19,000.
−Removed: The May 2018 Warrant has a cashless exercise feature.
−Removed: The Company issued a warrant to Aeon dated
−Removed: June 28, 2018 (“June 2018 Warrant”) for a Block Trade pursuant to the Engagement Agreement.
−Removed: The June 2018 Warrant provides
−Removed: Aeon with the right to purchase 1,923,077 shares of restricted Common Stock based upon a Block Trade.
−Removed: The Company classified the
−Removed: June 2018 Warrant as equity.
−Removed: The June 2018 Warrant has a term of five years with an exercise price of approximately $0.03 per warrant
−Removed: Using the Black-Scholes-Merton option pricing model, the Company determined the aggregate value of the June 2018 Warrant
−Removed: to be approximately $38,000.
−Removed: The June 2018 Warrant has a cashless exercise feature.
−Removed: The Company issued a warrant to Aeon dated
−Removed: November 1, 2018 (“November 2018 Warrant”) for a Block Trade pursuant to the Engagement Agreement.
−Removed: The November 2018
−Removed: Warrant provides Aeon with the right to purchase 2,272,727 shares of restricted Common Stock based upon a Block Trade.
−Removed: classified the November 2018 Warrant as equity.
−Removed: The November 2018 Warrant has a term of five years with an exercise price of approximately
−Removed: $0.01 per warrant share.
−Removed: Using the Black-Scholes-Merton option pricing model, the Company determined the aggregate value of the
−Removed: November 2018 Warrant to be approximately $19,000.
−Removed: The November 2018 Warrant has a cashless exercise feature.
−Removed: The Company issued a Warrant to Aeon dated
−Removed: June 13, 2019 (“June 2019 Warrant”) for a Block Trade pursuant to the Engagement Agreement.
−Removed: The June 2019 Warrant provides
−Removed: Aeon with the right to purchase 1,388,889 shares of restricted Common Stock based upon a Block Trade.
−Removed: The Company classified the
−Removed: June 2019 Warrant as equity.
−Removed: The June 2019 Warrant has a term of five years with an exercise price of approximately $0.01 per warrant
−Removed: Using the Black-Scholes-Merton option pricing model, the Company determined the aggregate value of the June 2019 Warrant
−Removed: to be approximately $9,000.
−Removed: The June 2019 Warrant has a cashless exercise feature.
−Removed: The Company issued a Warrant to Aeon dated
−Removed: July 15, 2019 (“July 2019 Warrant”) for a Block Trade pursuant to the Engagement Agreement.
−Removed: The July 2019 Warrant provides
−Removed: Aeon with a right to purchase 1,944,444 shares of restricted Common Stock based upon a Block Trade.
−Removed: The Company classified the
−Removed: July 2019 Warrant as equity.
−Removed: The July 2019 Warrant has a term of five years with an exercise price of approximately $0.01 per warrant
−Removed: Using the Black-Scholes-Merton option pricing model, the Company determined the aggregate value of the July 2019 Warrant
−Removed: to be approximately $12,000.
−Removed: The July 2019 Warrant has a cashless exercise feature.
−Removed: The Company issued two Warrants to Aeon
−Removed: dated August 7, 2019 (“August 2019 Warrants”) for two Block Trades pursuant to the Engagement Agreement.
−Removed: 2019 Warrants provide Aeon with a right to purchase 3,500,000 shares of restricted Common Stock based upon two Block Trades.
−Removed: Company classified the August 2019 Warrants as equity.
−Removed: The August 2019 Warrants have a term of five years with an exercise price
−Removed: of approximately $0.01 per warrant share.
−Removed: Using the Black-Scholes-Merton option pricing model, the Company determined the aggregate
−Removed: value of the August 2019 Warrants to be approximately $12,000.
−Removed: The August 2019 Warrants have a cashless exercise feature.
+Added: Effective June 13, 2019, the Company issued
+Added: a Common Stock Purchase Warrant to Aeon Capital, Inc.
+Added: (“Aeon”) for a Block Trade transaction.
+Added: The Company issued a
+Added: warrant to purchase 1,338,889 shares of common stock based upon the Block Trade transaction pursuant to the Company’s engagement
+Added: agreement with Aeon dated February 22, 2018 (“Aeon Engagement Agreement”).
+Added: The Company classified these warrants as
+Added: The warrants have a term of five years with an exercise price of approximately $0.01 per warrant share.
+Added: Using the Black-Scholes-Merton
+Added: option pricing model, the Company determined the aggregate fair value of these warrants to be approximately $9,000.
+Added: have a cashless exercise feature.
+Added: Effective July 15, 2019, the Company issued
+Added: a Common Stock Purchase Warrant to Aeon for a Block Trade transaction.
+Added: The Company issued a warrant to purchase 1,944,444 shares
+Added: of common stock based upon the Block Trade pursuant to the Aeon Engagement Agreement.
+Added: The Company classified these warrants as
+Added: The warrants have a term of five years with an exercise price of approximately $0.01 per warrant share.
+Added: Using the Black-Scholes-Merton
+Added: option pricing model, the Company determined the aggregate fair value of these warrants to be approximately $12,000.
+Added: have a cashless exercise feature.
+Added: Effective July 10, 2020, the Company issued
+Added: a Common Stock Purchase Warrant to Aeon for a Block Trade transaction.
+Added: The Company issued a warrant to purchase 4,100,000 shares
+Added: of common stock based upon the Block Trade pursuant to the Aeon Engagement Agreement.
+Added: The Company classified these warrants as
+Added: The warrants have a term of five years with an exercise price of $0.01 per warrant share.
+Added: Using the Black-Scholes-Merton
+Added: option pricing model, the Company determined the aggregate fair value of these warrants to be approximately $29,000.
+Added: have a cashless exercise feature.
+Added: Effective July 18, 2020, the Company issued
+Added: a Common Stock Purchase Warrant to Aeon for a Block Trade transaction.
+Added: The Company issued a warrant to purchase 3,500,000 shares
+Added: of common stock based upon the Block Trade pursuant to the Aeon Engagement Agreement.
+Added: The Company classified these warrants as
+Added: The warrants have a term of five years with an exercise price of approximately $0.01 per warrant share.
+Added: Using the Black-Scholes-Merton
+Added: option pricing model, the Company determined the aggregate fair value of these warrants to be approximately $18,000.
+Added: have a cashless exercise feature.
+Added: Effective July 19, 2020, the Company issued
+Added: a Common Stock Purchase Warrant to Aeon for a Block Trade transaction.
+Added: The Company issued a warrant to purchase 1,333,333 shares
+Added: of common stock based upon the Block Trade pursuant to the Aeon Engagement Agreement.
+Added: The Company classified these warrants as
+Added: The warrants have a term of five years with an exercise price of approximately $0.01 per warrant share.
+Added: Using the Black-Scholes-Merton
+Added: option pricing model, the Company determined the aggregate fair value of these warrants to be approximately $7,000.
+Added: have a cashless exercise feature.
+Added: Effective July 27, 2020, the Company issued
+Added: a Common Stock Purchase Warrant to Aeon for a Block Trade transaction.
+Added: The Company issued a warrant to purchase 2,500,000 shares
+Added: of common stock based upon the Block Trade pursuant to the Aeon Engagement Agreement.
+Added: The Company classified these warrants as
+Added: The warrants have a term of five years with an exercise price of approximately $0.01 per warrant share.
+Added: Using the Black-Scholes-Merton
+Added: option pricing model, the Company determined the aggregate fair value of these warrants to be approximately $13,000.
+Added: have a cashless exercise feature.
A summary of the Company’s warrant
−Removed: activity and related information for the nine months ended January 31, 2020 are shown below:
+Added: activity and related information for the three months ended July 31, 2020 is shown below:
Exercise Price
Outstanding, April 30, 2020
−Removed: Outstanding, January 31, 2020
−Removed: Exercisable, January 31, 2020
+Added: Outstanding, July 31, 2020
+Added: Exercisable, July 31, 2020
The following table summarizes additional
−Removed: information concerning warrants outstanding and exercisable at January 31, 2020:
+Added: information concerning warrants outstanding and exercisable at July 31, 2020:
Exercise Prices
1 unchanged sentence
Exercisable at
−Removed: October 31, 2019
+Added: April 30, 2020
Exercise Price
7 unchanged sentences
The Company had the following related party
−Removed: transactions during the three and nine months ended January 31, 2020 and 2019, respectively.
+Added: transactions during the three months ended July 31, 2020 and 2019.
The Company owns 14.5% of the equity in
−Removed: SG Austria which is reported on the cost method of accounting.
+Added: SG Austria and is reported on the cost method of accounting.
SG Austria has two subsidiaries:
1 unchanged sentence
and (ii) Austrianova
+Added: Thailand Pte Ltd.
The Company purchased products and services from these subsidiaries in the approximate amounts of $64,000 and
−Removed: $87,000 in the three and nine months ended January 31, 2020, respectively, and $48,000 and $168,000 for the three and nine months
−Removed: ended January 31, 2019, respectively.
−Removed: In April 2014, the Company entered into
−Removed: a consulting agreement (“Vin-de-Bona Consulting Agreement”) with Vin-de-Bona Trading Co.
−Removed: Ltd (“Vin-de-Bona”)
−Removed: pursuant to which it agreed to provide consulting services to the Company.
−Removed: Vin-de-Bona is owned by Prof.
−Removed: Günzburg
−Removed: (“Prof.
−Removed: Günzburg”) and Brian Salmons, PhD (“Dr.
−Removed: Salmons”), both of whom are involved in numerous aspects
−Removed: of the Company’s scientific endeavors relating to cancer and diabetes.
−Removed: Günzburg is the Chairman of Austrianova,
+Added: $2,400 in the three months ended July 31, 2020 and 2019, respectively.
+Added: In April 2014, the Company entered the
+Added: Vin-de-Bona Consulting Agreement pursuant to which it agreed to provide professional consulting services to the Company.
+Added: is owned by Prof.
+Added: Günzburg (“Prof.
+Added: Günzburg) and Dr.
+Added: Brian Salmons (“Dr.
+Added: Salmons”), both
+Added: of whom are involved in numerous aspects of the Company’s scientific endeavors relating to cancer and diabetes (Prof.
+Added: is the Chairman of Austrianova, and Dr.
Salmons is the Chief Executive Officer and President of Austrianova).
−Removed: The term of the Vin-de-Bona Consulting Agreement is
−Removed: for 12 months and automatically renews for successive 12-month terms.
−Removed: After the initial term, either party has the right to terminate
−Removed: the Vin-de-Bona Consulting Agreement by giving the other party 30 days’
+Added: The term of the agreement
+Added: is for 12 months, automatically renewable for successive 12-month terms.
+Added: After the initial term, either party can terminate the
+Added: agreement by giving the other party 30 days’
written notice before the effective date of termination.
−Removed: The amounts incurred for consulting services by Vin-de-Bona for the three and nine months ended January 31, 2020 were approximately
−Removed: $3,000 and $18,000, respectively, and $2,000 and $14,000 for the three and nine months ended January 31, 2019, respectively.
−Removed: addition, during the nine months ended January 31, 2020 the Company issued 250,000 common shares to Dr.
−Removed: Salmons for being a member
−Removed: of the Company’s Medical and Scientific Advisory Board.
−Removed: The Company recorded a noncash expense of approximately $7,300 relating
−Removed: to these shares for the nine months ended January 31, 2020.
−Removed: During the month of October 2019, the Company
−Removed: received $70,000 from an officer of the Company as a short-term payable that was non-interest bearing and due on demand.
−Removed: the three months ended January 31, 2020, the related party was repaid in full.
−Removed: During the nine months ended January 31,
−Removed: 2020, the Company issued one share of Series A Preferred Stock to the Chief Executive Officer of the Company for $1 pursuant to
−Removed: a subscription agreement.
+Added: The agreement has been
+Added: automatically renewed annually.
+Added: The amounts incurred for the three months ended July 31, 2020 and 2019 were approximately $13,000
+Added: and $13,000, respectively.
+Added: In addition, during the three months ended July 31, 2020 the Company issued 250,000 shares of common
+Added: The Company recorded a noncash consulting expense of approximately $8,000 relating to these share issuances
+Added: for the three months ended July 31, 2020.
+Added: During the year ended April 30, 2020, the
+Added: Company issued one share of Series A Preferred Stock to the Chief Executive Officer of the Company for $1 pursuant to a Subscription
The Series A Preferred Stock is described in detail in Note 12 –
Preferred Stock.
−Removed: During the three
−Removed: months ended January 31, 2020, the Board exercised its right to have the Company redeem the one share of Series A Preferred Stock.
+Added: The Board exercised its right
+Added: to have the Company redeem the one share of Series A Preferred Stock.
It is no longer issued and outstanding.
2 unchanged sentences
The Company acquires assets still in development
−Removed: and enters into license agreements with third parties that often require milestone and royalty payments to the third-party contingent
+Added: and enters R&D arrangements with third parties that often require milestone and royalty payments to the third-party contingent
upon the occurrence of certain future events linked to the success of the asset in development.
3 unchanged sentences
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 products if regulatory approval for marketing is obtained.
−Removed: The Company determines whether an arrangement
−Removed: is, or contains, a lease at inception of the agreement.
−Removed: Prior to May 1, 2019, the Company generally accounted for operating lease
−Removed: payments by charging them to expense as incurred.
−Removed: Beginning on May 1, 2019, operating leases that have commenced are included in
−Removed: other assets and accrued expenses in the condensed consolidated balance sheet.
−Removed: Classification of operating lease liabilities as
−Removed: either current or noncurrent is based on the expected timing of payments due pursuant to the Company’s obligations under
−Removed: The Company concluded that as of May 1, 2019, the lease liability and the ROU are immaterial to the condensed consolidated
−Removed: balance sheet;
−Removed: therefore, no amount was included in the condensed consolidated balance sheet.
−Removed: The Company leases office space related
−Removed: to the administrative activities and at January 31, 2020, the remaining term of the lease is seven months.
−Removed: The following table presents the minimum
−Removed: lease payments as of January 31, 2020.
−Removed: Total minimum lease payments
+Added: royalty payments based upon a percentage of the sales of the pharmaceutical product if regulatory approval for marketing of the
+Added: product candidate is obtained.
+Added: Effective September 1, 2017, the Company
+Added: entered into an office lease at 23046 Avenida de la Carlota, Suite 600, Laguna Hills, California (“Leased Premises”).
+Added: The term of the lease is for 24 months and expired on August 31, 2019.
+Added: In May 2019, the Company entered into an additional one-year
+Added: lease for the Leased Premises, commencing upon the expiration of the term of the prior lease.
+Added: The term of the lease expires on
+Added: August 31, 2020.
+Added: On May 28, 2020, the Company entered into
+Added: an additional six-month lease of the Leased Premises, commencing on September 1, 2020.
+Added: The term of the new lease expires on February
+Added: Rent expenses for these offices for the
+Added: three months ended July 31, 2020 and 2019 were $7,152 and $8,661, respectively.
+Added: The following table summarizes the Company’s
+Added: aggregate future minimum lease payments required under the operating lease as of July 31, 2020.
Material Agreements
2 unchanged sentences
Nature of Business –
−Removed: Company Background and Material Agreements.
−Removed: Service Agreements
−Removed: The Company has entered into several service
−Removed: agreements, with both independent and related parties, pursuant to which services will be provided over the next four to twenty-four
−Removed: months related to the Company’s planned IND filing.
−Removed: The services include regulatory affairs strategy, advice and completion
−Removed: of the IND submission to the FDA, container closure integrity testing of the clinical trial product syringes over the course of
−Removed: two years, a two year stability study and the preparation of angiography guidelines for implantation of the encapsulated cells
−Removed: for use in the Company’s planned clinical trial in LAPC.
−Removed: The total cost of such service agreements is estimated to be approximately
−Removed: $220,000, of which the related party portion will be $40,000.
+Added: Company Background.
Compensation Agreements
The Company entered into executive compensation
−Removed: agreements with its three executive officers in March 2015, each of which was amended in December 2015.
−Removed: The amendments provided
−Removed: that each executive compensation agreement has a term of two years with annual extensions thereafter unless the Company or the
−Removed: officer provides written notification of termination at least ninety days prior to the end of the term or subsequent extensions.
−Removed: The Company entered into a DLA with a new Board member in April 2015 which continues in effect until the member is no longer on
−Removed: In March 2017, the Company amended the
−Removed: executive compensation agreements with its three executive officers.
−Removed: The term for each agreement is two years from an effective
−Removed: date of January 1, 2017.
−Removed: At the same time, the Company amended the compensation agreement with the Board member referenced above.
−Removed: It continues in effect until the member is no longer on the Board.
+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 automatic annual extensions thereafter unless the Company or the officer provides written notification
+Added: of termination at least ninety days prior to the end of the term or subsequent extensions.
+Added: The Company also entered a compensation
+Added: agreement with a Board member in April 2015 which continued in effect until amended in May 2017.
+Added: In May 2017, the Company amended the compensation
+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.
1 unchanged sentence
(i) $12,500 in cash for each calendar quarter of service on the Board;
−Removed: fully-paid, non-assessable shares of restricted Common Stock (“Shares”) annually;
−Removed: and (iii) a five-year option to purchase
−Removed: 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
−Removed: the options fully vest on the date of the grants.
−Removed: NOTE 9 –
+Added: fully-paid, non-assessable shares of the Company’s restricted common stock (“Shares”) annually;
+Added: and (iii) a five-year
+Added: 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.
+Added: The Shares and the option Shares fully vest on the date of the grants.
+Added: NOTE 10 - INCOME TAXES
The Company had no income tax expense for
−Removed: the nine months ended January 31, 2020 and 2019, respectively.
−Removed: During the nine months ended January 31, 2020 and 2019, the Company
+Added: the three months ended July 31, 2020 and 2019, respectively.
+Added: During the three months ended July 31, 2020 and 2019, the Company
had a 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 $270,000 and $710,000 for the nine months ended January
+Added: allowances provided for the net deferred tax asset increased by approximately $98,000 and $201,000 for the three months ended July
31, 2020 and 2019, respectively.
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, 2020 and 2019.
+Added: the effective tax rate and the projected blended statutory tax rate for the three months ended July 31, 2020 and 2019.
Current tax laws limit the amount of loss
6 unchanged sentences
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, 2020.
+Added: Accordingly, 100% of the deferred tax valuation allowance has been recorded against these assets at July 31, 2020.
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, 2020 and 2019, the Company had accrued no interest or penalties related to uncertain tax positions.
+Added: As of the three months ended
+Added: July 31, 2020 and 2019, the Company had no accrued interest or penalties related to uncertain tax positions.
See Note 10 of Notes to the Consolidated
4 unchanged sentences
Basic earnings (loss) per share is computed
−Removed: by dividing earnings available to stockholders who own Common Stock by the weighted average number of shares outstanding during
−Removed: Diluted earnings per share is computed by dividing net income by the weighted average number of shares and potentially
+Added: by dividing earnings (loss) available to common stockholders by the weighted average number of shares outstanding during the period.
+Added: Diluted earnings (loss) per share is computed by dividing net income (loss) by the weighted average number of shares and potentially
dilutive shares of common stock outstanding during the period increased to include the number of additional shares of common stock
2 unchanged sentences
principally include stock options and warrants.
−Removed: During the nine months ended January 31, 2020 and 2019, the Company incurred losses.
+Added: During the three months ended July 31, 2020 and 2019, the Company incurred losses.
Accordingly, the effect of any common stock equivalent would be anti-dilutive during those periods and are not included in the
2 unchanged sentences
per share calculations:
−Removed: Nine Months Ended January 31,
+Added: Three Months Ended July 31,
+Added: $ (1,134,075 )
Basic weighted average number of shares outstanding
7 unchanged sentences
dilutive securities:
−Removed: Nine Months Ended January 31,
+Added: Three Months Ended July 31,
Excluded options
1 unchanged sentence
Total excluded options and warrants
−Removed: Three Months Ended January 31,
−Removed: Basic weighted average number of shares outstanding
−Removed: 1,375,499,976
−Removed: 1,126,904,505
−Removed: Diluted weighted average number of shares outstanding
−Removed: 1,375,499,976
−Removed: 1,126,904,505
−Removed: Basic and diluted loss per share
NOTE 12 –
PREFERRED STOCK
−Removed: The Company has authorized 10,000,000 shares
−Removed: of preferred stock, with a par value of $0.0001, of which one share has been designated as "Series A Preferred Stock".
+Added: The Company has authorized 10,000,000
+Added: shares of preferred stock, with a par value of $0.0001, of which one share has been designated as "Series A Preferred Stock".
The one share of Series A Preferred Stock was issued on October 30, 2019 and repurchased by the Company on December 3, 2019.
−Removed: of January 31, 2020, there are no shares of preferred stock issued and outstanding.
+Added: of July 31, 2020, there are no shares of preferred stock issued and outstanding.
The description of the Series A Preferred
2 unchanged sentences
There is one share of preferred stock designated as Series A Preferred Stock;
−Removed: The Series A Preferred Stock has a number of votes at any time equal to the number of votes then held by all other shareholders of the Company having a right to vote on any matter plus one.
−Removed: The Certificate of Designations that designated the terms of the Series A Preferred Stock cannot be amended without the consent of the holder of the Series A Preferred Stock;
+Added: Preferred Stock has a number of votes at any time equal to the number of votes then held by all other shareholders of the
+Added: Company having a right to vote on any matter plus one.
+Added: The Certificate of Designations that designated the terms of the
+Added: Series A Preferred Stock cannot be amended without the consent of the holder of the Series A Preferred Stock;
The Company may redeem the Series A Preferred Stock at any time for a redemption price of $1.00 paid to the holder of the share of Series A Preferred Stock;
2 unchanged sentences
SUBSEQUENT EVENTS
−Removed: On February 2, 2020, the Company entered
−Removed: into a share subscription agreement in a private placement for a total of 13,000,000 shares of restricted Common Stock for a total
−Removed: There were no fees payable by the Company or warrant coverage relating to the share subscription agreement and the
−Removed: securities were offered and sold without registration under the Securities Act of 1933 as amended, in reliance on Section 4(a)(2)
−Removed: From February 1, 2020 through March 13,
−Removed: 2020, the Company sold 40,000,000 shares of Common Stock using the S-3 structured as a Block Trade.
−Removed: The issuance of these shares
−Removed: resulted in gross proceeds to the Company of approximately $200,000.
−Removed: Pursuant to the Engagement Agreement with Aeon , the Company
−Removed: is required to pay Aeon a fee of 7%, which equals $14,000 and provide warrant coverage equal to 5% of the number of shares of Common
−Removed: Stock sold in the Block Trade with a five-year term which is 2 million warrant shares with an exercise price of $0.005 per
+Added: From August 1, 2020 through August 12,
+Added: 2020, the Company sold approximately 459 million shares of common stock using the S-3 structured as Block Trade transactions.
+Added: issuance of these shares resulted in gross proceeds to the Company of approximately $3 million.
+Added: Pursuant to the Aeon Engagement
+Added: Agreement, the Company paid Aeon a fee of approximately $183,000 and provided warrant coverage of 5% of the number of shares of
+Added: commons stock sold in the Block Trade transactions This amounted to approximately 34 million warrant shares with a five-year term.
+Added: The warrants have a cashless exercise feature.
+Added: In addition, the Company incurred transaction fees of approximately $96,000 to an
+Added: unrelated party.
+Added: On September 1, 2020, the Company submitted
+Added: the IND to the FDA to allow the Company to commence a Phase 2b human clinical trial involving LAPC.
+Added: Although no assurance as to
+Added: the timing of the trial can be given or whether the FDA will allow the Company to commence a Phase 2b clinical trial as opposed
+Added: to a Phase 1 clinical trial or further preclinical studies.
+Added: The IND consisted of all available preclinical information (e.g.
+Added: toxicity studies), Chemistry, Manufacturing and Controls information and other pre-clinical information about the Company’s
+Added: product candidate to treat LAPC, as well as information regarding the proposed clinical trial program and other information and
+Added: documentation required by FDA regulations.
+Added: On September 4, 2020, the Company received an Information Request from the FDA.
+Added: Company responded to the FDA’s Information Request on September 11, 2020.
Management’s Discussion and Analysis
1 unchanged sentence
Cautionary Note Regarding Forward-Looking
−Removed: This Report includes “forward-looking
−Removed: statements”
+Added: This Report on Form 10-Q (“Report”)
+Added: includes “forward-looking statements”
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,”
+Added: All statements other than
+Added: statements of historical fact are “forward-looking statements”
+Added: for purposes of this Report, including any projections
+Added: of earnings, revenue or other financial items, any statements regarding the plans and objectives of management for future operations,
+Added: any statements concerning proposed new products or services, any statements regarding future economic conditions or performance,
+Added: any statements regarding expected benefits from any transactions and any statements of assumptions underlying any of the foregoing.
+Added: In some cases, forward-looking statements can be identified by use of terminology such as “may,”
“will,”
10 unchanged sentences
or “continue,”
−Removed: or the negative thereof or other comparable terminology.
−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 –
+Added: or the negative
+Added: thereof or other comparable terminology regarding beliefs, plans, expectations or intentions regarding the future, including risks
+Added: relating to the recent outbreak of COVID-19.
+Added: Although we believe that the expectations reflected in the forward-looking statements
+Added: contained in this Report are reasonable, there can be no assurance that such expectations or any of the forward-looking statements
+Added: will prove to be correct, and actual results could differ materially from those projected or assumed in the forward-looking statements.
+Added: Thus, investors should refer to and carefully review information in future documents we file with the Commission.
+Added: Our future financial
+Added: condition and results of operations, as well as any forward-looking statements, are subject to inherent risk and uncertainties,
+Added: including, but not limited to, the risk factors set forth in “Part I, Item 1A –
Risk Factors”
−Removed: set forth in our Form 10-K for the year ended
−Removed: April 30, 2019 and for the other reasons described elsewhere in this Report.
−Removed: All forward-looking statements and reasons
−Removed: why results may differ included in this Report are made as of the date of this Report, and we do not intend to update any forward-looking
−Removed: statements except as required by law or applicable regulation.
−Removed: Except where the context otherwise requires, in this Report, the
−Removed: “Company,”
+Added: set forth in our
+Added: Form 10-K for period ended April 30, 2020 and for the reasons described elsewhere in this Report.
+Added: Among others, these include our
+Added: estimates regarding expenses, future revenues, capital requirements and needs for additional financing;
+Added: whether the FDA approves
+Added: our recently submitted IND after it has been reviewed by the FDA so that we can commence our planned clinical trial involving LAPC;
+Added: the success and timing of our preclinical studies and clinical trials;
+Added: the potential that results of preclinical studies and clinical
+Added: trials may indicate that any of our technologies and product candidates are unsafe or ineffective;
+Added: our dependence on third parties
+Added: in the conduct of our preclinical studies and clinical trials;
+Added: the difficulties and expenses associated with obtaining and maintaining
+Added: regulatory approval of our product candidates;
+Added: the material adverse impact that the coronavirus pandemic may have on our business,
+Added: including our planned clinical trial involving LAPC, which could materially affect our operations as well as the business or operations
+Added: of third parties with whom we conduct business;
+Added: and whether the FDA will approve our product candidates after our clinical trials
+Added: are completed, assuming the FDA allows our clinical trials to proceed after review of our IND submission for LAPC.
+Added: looking statements and reasons why results may differ included in this Report are made as of the date hereof, and we do not intend
+Added: to update any forward-looking statements except as required by law or applicable regulations.
+Added: Except where the context otherwise
+Added: requires, in this Report, the “Company,”
“we,”
1 unchanged sentence
and “our”
−Removed: refer to PharmaCyte Biotech, Inc., a Nevada corporation,
−Removed: and, where appropriate, its subsidiaries.
+Added: refer to PharmaCyte
+Added: Biotech, Inc., a Nevada corporation, and, where appropriate, its subsidiaries.
+Added: Product Candidates
We are a biotechnology company focused
−Removed: on developing and preparing to commercialize cellular therapies for various types of cancer and for diabetes that are based upon
−Removed: a proprietary cellulose-based live cell encapsulation technology known as “Cell-in-a-Box ®
+Added: on developing cellular therapies for cancer and diabetes based upon a proprietary cellulose-based live cell encapsulation technology
+Added: known as “Cell-in-a-Box ®
The Cell-in-a-Box ®
−Removed: technology is intended to be used as a platform upon which therapies for several types of cancer, including LAPC, and diabetes
−Removed: are being developed.
−Removed: A critical unmet medical need exists for
−Removed: patients with LAPC whose tumor in a patient’s pancreas no longer responds after 4-6 months of treatment with either Abraxane ®
−Removed: plus gemcitabine or the 4-drug combination known as FOLFIRINOX (both combinations are the current standards of care).
−Removed: These patients
−Removed: have no effective treatment alternative once their tumor no longer responds to these therapies.
−Removed: Two commonly used treatments for
−Removed: such patients are 5-FU or capecitabine plus radiation (chemoradiation therapy).
−Removed: Both treatments are only marginally effective in
−Removed: treating the tumor and result in serious side effects.
−Removed: Recently, radiation treatment alone is being used at some cancer centers
−Removed: For LAPC, our therapy is comprised of implanting
−Removed: encapsulated genetically modified live cells in the blood supply as close to the tumor in the pancreas as possible followed by
−Removed: the administration of low doses of the cancer prodrug ifosfamide.
−Removed: We believe that our therapy can serve as a “consolidation
−Removed: therapy”
−Removed: with the current standards of care for patients with LAPC and meet the critical unmet medical need.
−Removed: We are currently
−Removed: working on an IND to submit to the FDA so that we can commence a Phase 2b clinical trial involving LAPC.
−Removed: We are continuing to work on projects related
−Removed: to the planned IND submission involving LAPC.
−Removed: Among other things, this work includes completion of each Module within the IND,
−Removed: the Investigator’s Brochure, the Pharmacy Manual, the Protocol for the LAPC clinical trial, a container closure integrity
−Removed: test of our clinical trial product that will be conducted over the course of two years, a pyrogenicity test, preparation of the
−Removed: angiography guidelines for implantation of the encapsulated cells for use in the LAPC clinical trial and a two-year stability study
−Removed: of our clinical trial product.
−Removed: The work also includes preparation of a Drug Master File, drafting change history related to the
−Removed: manufacturing process that existed when the preclinical studies involving our product were conducted compared to the current manufacturing
−Removed: process for our clinical trial product and publication of the IND in concert with our U.S.
−Removed: Agent for the FDA.
−Removed: The plan is to initially conduct the LAPC
−Removed: trial in the U.S.
−Removed: with possible study sites in Europe at a later date.
−Removed: However, no assurance can be given that we will be able
−Removed: to make the IND submission to the FDA or that the FDA will approve our submission.
−Removed: We are also developing ways to use the
+Added: technology is intended to be used as a
+Added: platform upon which therapies for several types of cancer, including LAPC and Type 1 and insulin dependent Type 2 diabetes will
+Added: be developed.
+Added: We are 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
+Added: prodrug into its cancer-killing form, encapsulating those cells using the Cell-in-a-Box ®
+Added: technology and placing
+Added: those capsules in the body as close as possible to the tumor.
+Added: In this way, we believe that when the cancer prodrug is administered
+Added: to a patient with a particular type of cancer that may be affected by the prodrug, the killing of the patient’s tumor may
+Added: be optimized.
+Added: On September 1, 2020, we submitted our
+Added: IND to the FDA for a Phase 2b clinical trial in LAPC.
+Added: However, no assurance as to the timing of the trial can be given or whether
+Added: the FDA will allow us to commence a Phase 2b clinical trial as opposed to a Phase 1 clinical trial or further preclinical studies.
+Added: The IND consisted of all available preclinical information (e.g.
+Added: animal toxicity studies), Chemistry, Manufacturing and Controls
+Added: information and other pre-clinical information about our product candidate to treat LAPC, as well as information regarding our
+Added: proposed clinical trial program and other information and documentation required by FDA regulations.
+Added: On September 4, 2020, we received
+Added: an Information Request from the FDA.
+Added: We responded to the FDA’s Information Request on September 11, 2020.
+Added: We must wait a minimum of 30 calendar days
+Added: from the date of the IND submission before initiating our clinical trial.
+Added: During this time, the FDA has an opportunity to review
+Added: the IND to ensure that it is complete and that the planned clinical trial research patients will not be subject to unreasonable
+Added: It also gives the FDA time to ask for more information and clarification about the information submitted as was done with
+Added: the FDA’s September 4, 2020 Information Request.
+Added: If the FDA is not satisfied with the our September 11, 2020 response to
+Added: the Information Request or our responses to any future Information Requests or the FDA identifies other issues with the our IND,
+Added: the FDA can place a clinical hold on the clinical trial described in the IND.
+Added: If the FDA does so, we cannot initiate the clinical
+Added: trial to treat LAPC until or unless the FDA lifts the clinical hold.
+Added: It is possible that the FDA may not permit us to initiate
+Added: the clinical trial based on the available data and information.
+Added: We are also examining ways to exploit the
benefits of the Cell-in-a-Box ®
−Removed: technology to treat forms of cancer that are based upon the use of cannabinoids
−Removed: from Cannabis as prodrugs in much the same way that the Cell-in-a-Box ®
−Removed: plus the cancer prodrug ifosfamide
−Removed: will be used to treat LAPC.
−Removed: Until the IND involving LAPC has been submitted to the FDA, we are not spending any further resources
−Removed: developing this program.
+Added: technology to develop therapies for cancer that involve prodrugs based upon certain
+Added: constituents of the Cannabis plant;
+Added: these constituents are of the class of compounds known as “cannabinoids”.
+Added: Until the FDA allows us to commence the clinical trial involving LAPC described in our recently submitted IND, we will not spend
+Added: any further resources developing this program.
In addition, we are developing a therapy
6 unchanged sentences
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 IND involving LAPC has been submitted to the FDA, we are not spending any further resources
−Removed: developing this program.
−Removed: Finally, we are developing a therapy for
−Removed: Type 1 diabetes and insulin-dependent Type 2 diabetes.
−Removed: Our diabetes therapy consists of encapsulating genetically modified human
−Removed: liver cells, beta islet cells and/or insulin-producing stem cells using the Cell-in-a-Box ®
−Removed: technology and then
−Removed: implanting them in the body to act as a bio-artificial pancreas for insulin production.
−Removed: As with the two previous programs, we are
−Removed: not spending any further resources developing this program until the IND involving LAPC has been submitted to the FDA.
−Removed: work at UTS on the Melligen cells continues.
−Removed: The work is being funded by us and UTS.
−Removed: Our portion of the funding was previously
+Added: our Cannabis program, until the FDA allows us to commence the clinical trial involving LAPC described in our recently submitted
+Added: IND, we will not spend any further resources developing this program.
+Added: We are also developing a therapy for Type
+Added: 1 diabetes and insulin-dependent Type 2 diabetes.
+Added: Our diabetes therapy consists of encapsulated genetically modified human liver
+Added: cells and insulin-producing stem cells.
+Added: The encapsulation for each type of cell will be done using the Cell-in-a-Box ®
+Added: Implanting these cells in the body is designed to function as a bio-artificial pancreas for purposes of insulin
+Added: As with the two previous programs, we are not spending any further resources developing this program until the FDA
+Added: allows us to commence the clinical trial involving LAPC described in our recently submitted IND.
+Added: However, work at UTS on the Melligen
+Added: cells continues.
+Added: Melligen cells are human liver cells that have been genetically engineered to produce, store and release insulin
+Added: in response to the levels of blood sugar in the body.
+Added: Finally, we have licensed from Hai Kang
+Added: the right to certain technology owned or controlled by Hai Kang related to COVID-19 diagnostic kits (“Kits”).
+Added: is both for the sale of Kits as well as for the use of the technology underlying the Kits.
+Added: Pursuant to the Hai Kang License Agreement,
+Added: we may directly (or through a third party) conduct research, use, develop, market, sell, distribute, import and export Kits and
+Added: utilize their underlying technology for human and veterinary uses in North America, the United Kingdom and certain other European
+Added: sites collectively, (“Territory”).
+Added: A “Product”
+Added: is defined as any existing Kit of Hai Kang or any future
+Added: Kit derived from Hai Kang’s Kits and includes an in vitro diagnostic test.
+Added: We are required to use its commercially
+Added: reasonable efforts to develop and commercialize at least one Product in the Territory.
+Added: This obligation to develop and commercialize
+Added: a Product includes, among other things, the performance of non-clinical and clinical studies of any Product, the preparation, filing
+Added: and prosecution of certain regulatory requests for authorization or approval for such Product (including to allow the Company to
+Added: market and sell the Product and to get the Product approved for reimbursement).
+Added: Hai Kang is responsible for all aspects of the
+Added: manufacture and supply of the Products to be developed and sold under the Hai Kang License Agreement.
+Added: During the term of the Hai Kang License
+Added: Agreement, we are required to pay a monthly fee to Hai Kang in the amount of $6,000, which monthly fee increases to $50,000 once
+Added: the first Product receives regulatory authorization or approval from the FDA.
+Added: In addition, upon the first commercial sale of a
+Added: Product, the Company is required to make quarterly royalty payments equal to 10% of Net Sales (as defined in the Hai Kang License
+Added: Agreement) of any Product sold pursuant to the Hai Kang License Agreement.
+Added: With respect to the Hai Kang License Agreement
+Added: and related products, including the Kits, we may not be able to (i) develop a related product candidate with our current resources,
+Added: on a timely basis, or at all;
+Added: (ii) obtain the necessary regulatory authorizations or approvals for such a product candidate or
+Added: (iii) commercialize any such product candidate or Kit;
+Added: or (iv) obtain reimbursement for such a product candidate or
+Added: Kit in the U.S.
+Added: and elsewhere.
+Added: It is uncertain that any such product candidates or Kit will comply with U.S.
+Added: regulatory requirements
+Added: or that any health care facility or provider will be willing or able to use such product candidates or Kits.
+Added: COVID-19 Potential Impact on the Financial
+Added: Condition and Results of Operations
+Added: The development of our product candidates
+Added: could be disrupted and materially adversely affected in the future by a pandemic like the recent outbreak of COVID-19.
+Added: as a result of measures imposed by the governments in states affected by COVID-19, businesses and schools have been suspended due
+Added: to quarantines or stay at home orders intended to contain the pandemic.
+Added: COVID-19 continues to spread globally and, as of July 31,
+Added: 2020, has spread to over 150 countries, including the U.S.
+Added: While the COVID-19 pandemic is thought to be in its early stages, international
+Added: stock markets continue to reflect the uncertainty associated with the slow-down in the world economies and the reduced levels of
+Added: international travel experienced since the beginning of January 2020.
+Added: As of the date of this Report, the COVID-19 pandemic has
+Added: had an impact upon our operations, although we believe that impact is not material.
+Added: We are still assessing our business plans
+Added: and the impact COVID-19 may have on our ability to advance the development of our product candidates or to raise financing to
+Added: support the development of our product candidates, but no assurances can be given that this assessment will enable us to avoid
+Added: part or all of any impact from the spread of COVID-19 or its consequences, including downturns in the business sector generally
+Added: or in our sector in particular.
+Added: The spread of COVID-19 may also result in the inability of our suppliers to deliver components
+Added: or raw materials on a timely basis or materially and adversely affect our collaborators’
+Added: and potential strategic partners’
+Added: ability to conduct our planned clinical trial in LAPC and our other operations.
+Added: The recent and ongoing COVID-19 pandemic could
+Added: materially affect our operations, as well as the business or operations of third parties with whom we conduct business.
+Added: could be adversely affected by the effects of other future health pandemics in regions where we or third parties on which we rely
+Added: have significant business operations.
+Added: See the risk factors set forth in “Part I, Item 1A –
+Added: Risk Factors”
+Added: forth in our Form 10-K for period ended April 30, 2020 and for the reasons described elsewhere in this Report.
Performance Indicators
Non-financial performance indicators used
−Removed: by management to manage and assess how the business is progressing include, but are not limited to, the ability to:
+Added: by management to manage and assess how the business is progressing will include, but are not limited to, the ability to:
appropriate funding for all aspects of our operations;
−Removed: (ii) complete necessary contracts;
−Removed: (iii) complete activities for producing
−Removed: genetically modified live cells that can convert a cancer prodrug to its cancer-killing form and having them encapsulated and grown
−Removed: in the capsules for use in our planned preclinical studies and clinical trials;
−Removed: (iv) complete all tests required by the FDA for
−Removed: our cellular therapies;
−Removed: (v) ensure the manufacture of our encapsulated live cells is in compliance with current good manufacturing
−Removed: practice (“GMP”) regulations as required by the applicable regulatory agencies so they may be used in our clinical
−Removed: and (vi) have regulatory work completed to enable studies and trials to be submitted to regulatory agencies and be GMP
−Removed: There are numerous factors required to
−Removed: be completed successfully to ensure our final product candidates are ready for use in our clinical trials.
−Removed: Therefore, the effects
−Removed: of material transactions with related parties and certain other parties to the extent necessary for such an undertaking may have
−Removed: substantial effects on both the timeliness and success of our current and prospective financial position and operating results.
+Added: (ii) acquire and complete necessary contracts;
+Added: (iii) complete activities
+Added: for producing genetically modified human cells and having them encapsulated for our preclinical studies and the planned clinical
+Added: trial in LAPC;
+Added: (iv) have regulatory work completed to enable studies and trials to be submitted to regulatory agencies;
+Added: all required tests and studies on the cells and capsules we plan to use in our clinical trial in patients with LAPC;
+Added: and (vi) ensure
+Added: completion of the production of encapsulated cells according to cGMP regulations
+Added: to use in our planned clinical trial involving LAPC.
+Added: There are numerous items required to be
+Added: completed successfully to ensure our final product candidate is ready for use in our planned clinical trial involving LAPC.
+Added: effects of material transactions with related parties, and certain other parties to the extent necessary for such an undertaking,
+Added: may have substantial effects on both the timeliness and success of our current and prospective financial position and operating
+Added: Nonetheless, we are actively working to ensure strong ties and interactions to minimize the inherent risks regarding success.
+Added: We do not believe there are factors which will cause materially different amounts to be reported than those presented in this Report.
+Added: We aim to assess this regularly to provide accurate information to our shareholders.
Results of Operations
−Removed: Three and nine months ended January 31, 2020 compared
−Removed: to three and nine months ended January 31, 2019
−Removed: We had no revenues for the three and nine months ended January
−Removed: 31, 2020 and 2019.
+Added: Three months ended July 31, 2020 compared to three months
+Added: ended July 31, 2019
+Added: We had no revenues for the three months ended July 31, 2020 and 2019.
Operating Expenses and Loss from Operations
The following table summarizes our operating
−Removed: expenses and loss from operations for the three and nine months ended January 31, 2020 and 2019, respectively:
−Removed: Three Months Ended January 31,
−Removed: Nine Months Ended January 31,
+Added: expenses and loss from operations for the three months ended July 31, 2020 and 2019, respectively:
+Added: Three Months Ended July 31,
The total operating expenses for the three-month
−Removed: period ended January 31, 2020 increased by $198,961 from the three months ended January 31, 2019.
−Removed: The increase is attributable
−Removed: to an increase in R&D expenses of $54,152, an increase in director fees of $29,269, an increase in compensation expense of
−Removed: $34,435, an increase in legal and professional expense of $59,307 and an increase in general and administrative expenses of $21,798.
−Removed: The total operating expenses for the nine-month
−Removed: period ended January 31, 2020 increased by $148,221 from the nine months ended January 31, 2019.
+Added: period ended July 31, 2020 decreased by $252,399 from the three months ended July 31, 2019.
+Added: The decrease is attributable to a decrease
+Added: in general and administrative (“G&A”) expenses of $304,400, a decrease in director fees of $3,618, a decrease in
+Added: compensation expense of $174,224 net of an increase in legal and professional expense of $31,599 and an increase in R&D expense
+Added: The decrease in G&A expenses were mainly attributable to reductions in consulting fees and travel expenses.
+Added: Other expense
+Added: The following table sets forth our other expense for the three
+Added: months ended July 31, 2020 and 2019:
+Added: Months Ended July 31,
+Added: Total other expense for the three months
+Added: ended July 31, 2020 increased by the amount of $2,268 from the three months ended July 31, 2019.
The increase is attributable to
−Removed: an increase in director fees of $48,263, an increase in legal and professional expense of $99,824 and an increase in general and
−Removed: administrative expenses of $132,513, and an increase in compensation expense of $106,094, net of a decrease in R&D expenses
−Removed: The increase in general and administrative expenses was mainly attributable to an increase in travel expense net of
−Removed: a decrease in consulting expense.
+Added: the increase of interest expense in the amount of $388, an increase in income taxes of $800 and an increase in foreign exchange
+Added: losses of $1,080.
Discussion of Operating, Investing and
1 unchanged sentence
The following table presents a summary of our sources and uses
−Removed: of cash for the nine months ended January 31, 2020 and 2019, respectively:
−Removed: Nine Months Ended
−Removed: January 31, 2020
−Removed: January 31, 2019
+Added: of cash for the three months ended July 31, 2020 and 2019, respectively:
+Added: Three Months Ended
+Added: July 31, 2020
+Added: July 31, 2019
Net cash used in operating activities:
2 unchanged sentences
Effect of currency rate exchange
−Removed: Net decrease in cash
+Added: Net increase (decrease) in cash
Operating Activities :
The net cash used in operating activities
−Removed: for the nine months ended January 31, 2020 is a result of our net losses, increases in accounts payable and accrued expenses,
−Removed: a decrease in prepaid expenses and an increase in securities issued for services and compensation.
+Added: for the three months ended July 31, 2020 is a result of our net losses, increases in accounts payable, a decrease in prepaid expenses
+Added: and an increase in securities issued for services and compensation, net of a decrease in accrued expenses.
The cash used in operating
−Removed: activities for the nine months ended January 31, 2019 is a result of our net losses, offset by an increase in stock issued, decreases
−Removed: to prepaid expenses and in accounts payable and an increase in accrued expenses.
−Removed: See Condensed Consolidated Statements of Cash
−Removed: Flows on page 7.
+Added: activities for the three months ended July 31, 2019 is a result of our net losses, offset by an increase in stock issued, an increase
+Added: to prepaid expenses and decreases in accounts payable and accrued expenses.
+Added: See Condensed Consolidated Statements of Cash Flows
Investing Activities :
−Removed: There were no investing activities in the nine months ended
−Removed: January 31, 2020 and 2019.
+Added: There were no investing activities in the three months ended
+Added: July 31, 2020 and 2019.
Financing Activities :
The cash provided from financing activities
−Removed: is mainly attributable to the proceeds from the sale of Common Stock.
+Added: is mainly attributable to the proceeds from the sale of our common stock net of the use of funds for payment of insurance financing.
Liquidity and Capital Resources
−Removed: As of January 31, 2020, our cash totaled
−Removed: approximately $142,000, compared to approximately $699,000 at January 31, 2019.
−Removed: Working capital was approximately a negative $810,000
−Removed: at January 31, 2020 and approximately $227,000 at January 31, 2019.
−Removed: The decrease in cash is attributable to a lower beginning cash
−Removed: balance, a decrease in proceeds from the sale of Common Stock offset by an increase in our operating expenses which generated a
−Removed: During the nine months ended January 31,
+Added: As of July 31, 2020, our cash totaled approximately
+Added: $2,167,000, compared to approximately $328,000 at July 31, 2019.
+Added: Working capital was approximately $1,116,000 at July 31, 2020
+Added: and approximately a negative $130,000 at July 31, 2019.
+Added: The increase in cash is attributable to a higher beginning cash balance,
+Added: an increase in proceeds from the sale of our common stock offset by a decrease in our operating expenses.
+Added: As of August 31, 2020,
+Added: our cash totaled approximately $4,537,000.
+Added: During the three months ended July 31,
2020, funding was provided by investors to maintain and expand our operations and R&D.
−Removed: Sales of Common Stock were consummated
+Added: Sales of our common stock were consummated
using the S-3.
−Removed: From May 1, 2019 through August 12, 2019, we continued to acquire funds through our S-3 pursuant to Block Trades
+Added: During the three months ended July 31, 2019, we continued to acquire funds through our S-3 pursuant to Block Trades
transactions in a program which is structured to provide up to $25 million dollars to us less certain commissions pursuant to the
−Removed: We also raised funds from private placements with investors.
−Removed: From May 1, 2019 through January 31, 2020 we raised capital from
−Removed: private placements of approximately $1,400,000.
−Removed: As of August 13, 2019, we did not meet
+Added: As of August 13, 2020, we no longer met
the eligibility requirements to use the S-3.
−Removed: In late January 2020, we regained our eligibility to use the S-3.
−Removed: We plan to sell shares of our registered
−Removed: Common Stock using the S-3 until we file our Annual Report on Form 10-K for the fiscal year ended April 30, 2020 with the Commission,
−Removed: at which time we believe the S-3 will no longer be available.
−Removed: We will need to raise additional funds to complete preparation of
−Removed: our IND filing with the FDA relating to LAPC.
In Note 2 –
7 unchanged sentences
or capital resources.
−Removed: The future royalty and other payments under
−Removed: the Third Addendum, as amended, are royalty payments of 4% royalty on all gross sales by us and 20% royalty of the amount we receive
−Removed: form sublicensees’
−Removed: gross sales, provided, however, that in the event the amounts received by us from sublicensees is 4% or
−Removed: less of sublicensees’
−Removed: gross sales SG Austria will receive 50% of what we receive up to 2%.
−Removed: In addition, SG Austria will receive
−Removed: 20% of any amount we receive over a 4% royalty payment from our sublicensees.
−Removed: SG Austria will also receive 50% of any other financial
−Removed: and non-financial consideration received by us from sublicensees of the Cell-in-a-Box ®
−Removed: The future royalty and other payments under
−Removed: the Diabetes License Agreement are royalty payments of 4% royalty on all gross sales by us and 20% royalty of the amount we receive
−Removed: from sublicensees’
−Removed: gross sales, provided, however, that in the event the amounts received by us from sublicensees is 4% or
−Removed: less of sublicensees’
−Removed: gross sales, Austrianova will receive 50% of what we receive up to 2%.
−Removed: In addition, Austrianova will
−Removed: receive 20% of any amount we receive over a 4% royalty payment from sublicensees.
−Removed: Austrianova will also receive 50% of any other
−Removed: financial and non-financial consideration received by us from sublicensees of the Cell-in-a-Box ®
−Removed: The future royalty and other payments under
−Removed: the Cannabis License Agreement are royalty payments of 4% royalty on all gross sales by us and 20% royalty of the amount we receive
−Removed: form sublicensees’
−Removed: gross sales, provided, however, that in the event the amounts received by us from sublicensees is 4% or
−Removed: less of sublicensees’
−Removed: gross sales, Austrianova will receive 50% of what we receive up to 2%.
−Removed: In addition, Austrianova will
−Removed: receive 20% of any amount we receive from sublicensees over a 4% royalty payment.
−Removed: Austrianova will also receive 50% of any other
−Removed: financial and non-financial consideration received by us from sublicensees of the Cell-in-a-Box ®
−Removed: The future royalty, milestone and patent
−Removed: prosecution costs under the Melligen Cell License Agreement are:
−Removed: (i) 6% royalty on gross sales;
−Removed: (ii) 25% royalty on sublicense
−Removed: (iii) milestone payments of $50,000 after the first preclinical study;
−Removed: (iv) $100,000 after the successful conclusion
−Removed: of a Phase 1 clinical trial;
−Removed: (v) $450,000 after the successful conclusion of a Phase 2 clinical trial;
−Removed: (vi) $3,000,000 after the
−Removed: successful conclusion of a Phase 3 clinical trial;
−Removed: and (vii) 15% of the costs paid by UTS to prosecute and maintain patents related
−Removed: to the licensed intellectual property.
+Added: On May 14, 2018, we entered into the Amendments
+Added: to all of the material agreements with SG.
+Added: Austria and Austrianova.
+Added: See “Company Background and Material Agreements”
+Added: above for a description of these Amendments.
Service Agreements
We entered into several service agreements,
−Removed: with both independent and related parties, pursuant to which services will be provided over the next four to twenty-four months
−Removed: related to our IND involving LAPC.
−Removed: The services include regulatory affairs strategy, advice and completion of the IND submission
−Removed: to the FDA, container closure integrity testing of the clinical trial product syringes over the course of two years, a two year
−Removed: stability study and the preparation of angiography guidelines for implantation of the encapsulated cells for use in our planned
−Removed: clinical trial in LAPC.
−Removed: The total cost is estimated to be approximately $220,000, of which the related party portion will be $40,000.
−Removed: Contractual Obligations
−Removed: As of January 31, 2020, we leased office
−Removed: space in Laguna Hills, California under a lease ending August 31, 2020.
−Removed: The following table presents certain payments
−Removed: due by us as of January 31, 2020 with respect to our known contractual obligations:
−Removed: Payments due by period
−Removed: Contractual Obligations
−Removed: Capital Leases
−Removed: Operating Leases
−Removed: Purchase Obligations
−Removed: Other Long-Term Liabilities Reflected on the Company’s Balance Sheet under U.S.
−Removed: Critical Accounting Estimates and Policies
−Removed: Our Condensed Consolidated Financial Statements
−Removed: are prepared in accordance with U.S.
−Removed: GAAP for interim financial information and are presented in accordance with the requirements
−Removed: of Regulation S-X of the Commission and with the instructions to Form 10-Q.
−Removed: However, they do not include all the information and
−Removed: Notes required by U.S.
−Removed: GAAP for complete Condensed Consolidated Financial Statements.
−Removed: In connection with the preparation of our
−Removed: Condensed Consolidated Financial Statements in this Report, we are required to make assumptions and estimates about future events
−Removed: and apply judgments that affect the reported amounts of assets, liabilities, revenue and expenses and the related disclosures.
−Removed: We base our assumptions, estimates and judgments on historical experience, current trends and other factors that management believes
−Removed: to be relevant at the time the financial statements are prepared.
−Removed: On a regular basis, management reviews the accounting policies,
−Removed: assumptions, estimates and judgments to ensure that our Condensed Consolidated Financial Statements are presented fairly and in
−Removed: accordance with U.S.
−Removed: However, because future events and their effects cannot be determined with certainty, actual results
−Removed: could differ from our assumptions and estimates, and such differences could be material.
−Removed: We discuss our critical accounting estimates
−Removed: and policies in Part II, Item 7.
−Removed: "Management’s Discussion and Analysis of Financial Condition and Results of Operations"
−Removed: of our Annual Report on Form 10-K for the year ended April 30, 2019.
−Removed: There has been no material change in our critical accounting
−Removed: estimates and policies since April 30, 2019.
+Added: with both independent and related parties, pursuant to which services will be provided over the next twenty-four months related
+Added: to our IND and clinical trial involving LAPC.
+Added: The services include regulatory affairs strategy, advice and follow up work of the
+Added: IND submission to the FDA and services related to the planned LAPC trial.
+Added: They also cover a 24-month stability study, which includes
+Added: the container closure integrity testing, of the clinical trial product syringes.
+Added: The total cost is estimated to be approximately
+Added: $195,000, of which the related party portion will be approximately $80,000.
New Accounting Pronouncements
16 unchanged sentences
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.