Product Development - The company is focused on developing cellular therapies for cancer, diabetes, and malignant ascites using its proprietary Cell-in-a-Box technology [129]. - The current product candidate, CypCaps™, is intended for use in therapies for several types of cancer, including locally advanced pancreatic cancer (LAPC) [129]. - The company is developing therapies for Type 1 diabetes and insulin-dependent Type 2 diabetes using encapsulated genetically modified insulin-producing cells [133][135]. - The company is also exploring the use of its technology for therapies involving prodrugs based on constituents of the Cannabis plant, but further development is on hold until FDA approval is obtained [134]. - The encapsulation technology aims to create a micro-environment for genetically engineered live human cells, enhancing their survival and production of active molecules [130]. - The company is evaluating the potential for cellular and humoral immune reactivity against the heterologous rat CYP2B1 protein as part of its clinical trial preparations [140]. Regulatory and Clinical Trials - The FDA has placed a clinical hold on the company's Investigational New Drug (IND) application for LAPC since October 1, 2020, requiring additional data and studies to lift the hold [137]. - The company has curtailed spending on development programs pending a review by the Business Review Committee, which may delay timelines for addressing the FDA clinical hold [129][136]. - The company is in the latter stages of conducting studies to address FDA requests, including genetic stability studies and compatibility assessments of delivery devices [139]. - The company has entered into service agreements estimated at approximately $482,000 to address the clinical hold on its IND submission involving LAPC [160]. Financial Performance - No revenues reported for the three months ended July 31, 2023, consistent with the same period in 2022 [146]. - Total operating expenses for the three months ended July 31, 2023, were $2,075,326, an increase of $394,718 (approximately 23.5%) compared to the same period in 2022 [147]. - Research and Development (R&D) expenses decreased by 34% to $104,483 for the three months ended July 31, 2023, compared to $159,273 in 2022 [148]. - General and administrative, legal, and professional expenses increased by 47% to $1,680,630 for the three months ended July 31, 2023, compared to $1,140,890 in 2022 [148]. - Other net expenses for the three months ended July 31, 2023, were $(1,107,971), compared to other income of $135,596 in the same period in 2022 [149]. - Net cash used in operating activities for the three months ended July 31, 2023, was $342,959, a significant improvement from $(1,084,378) in 2022 [151]. - Cash and cash equivalents totaled approximately $75 million as of July 31, 2023, down from approximately $82 million in 2022 [156]. - Working capital was approximately $73 million as of July 31, 2023, compared to approximately $81 million in 2022 [156]. - The company repurchased common stock amounting to approximately $26,457,000 during the three months ended July 31, 2023 [154]. - The company raised approximately $32,736,000 from the issuance of preferred stock, net of issuance costs, during the same period [154]. - The company sold 35,000 Preferred Shares and Warrants for gross proceeds of $35 million, with potential additional proceeds of approximately $35 million if all Warrants are exercised [157]. - The company expects to fund operating expenses for at least the next 12 months using existing cash balances and may consider additional debt or equity issuances [158]. Accounting and Reporting - The company’s financial statements are prepared in accordance with U.S. GAAP, requiring management to make critical accounting estimates and judgments [161]. - Research and Development expenses are expensed as incurred, including costs for technologies with no alternative future use [163]. - Stock-based compensation is measured and recognized according to ASC 718, impacting the company's financial results [164]. - Basic net income (loss) per share is calculated using the weighted-average number of shares outstanding, with potentially dilutive options excluded due to anti-dilutive effects [165]. Risk Management - The Board is reviewing risks associated with the company's relationship with SG Austria, which may impact the development of its product candidates [129].

Financial Performance - As of April 30, 2023, the company's cash and cash equivalents totaled approximately $68 million, down from approximately $85.4 million as of April 30, 2022, indicating a decrease of about 20.3%[390] - Total operating expenses for the year ended April 30, 2023, were $6,455,494, an increase of $2,063,480 or approximately 47.5% compared to the previous year[401] - Loss from operations for the year ended April 30, 2023, was $6,455,494, reflecting an increase of $2,063,480 or about 47.5% from the year ended April 30, 2022[403] - Other income for the year ended April 30, 2023, was $2,139,501, compared to $152,853 in the previous year, representing a significant increase attributed mainly to interest income[404] - The company had no revenues for the fiscal years ended April 30, 2023, and 2022[400] - The company reported a net cash used in operating activities of $(3,793,731) for the year ended April 30, 2023, compared to $(4,117,319) for the year ended April 30, 2022, showing an improvement[406] Share Structure - The company completed a 1:1500 reverse stock split effective July 12, 2021, reducing the authorized number of shares from 50 billion to 33,333,334[384] - On March 14, 2023, the company increased the number of authorized shares to 133,333,334 shares[385] Research and Development - The company is preparing for a clinical trial in LAPC using encapsulated live cells, following a clinical hold placed by the FDA on its IND submission[378][379] - The company is developing a potential therapy for Type 1 diabetes using encapsulated genetically modified insulin-producing cells, aimed at functioning as a bio-artificial pancreas[382] Cash Flow Activities - Cash used in operating activities for the year ended April 30, 2023, was primarily due to net losses, offset by securities issued for services and changes in prepaid expenses, accounts payable, and accrued expenses[407] - No investing activities were reported for the years ended April 30, 2023, and 2022[408] - Cash used in financing activities for the year ended April 30, 2023, was mainly attributable to Repurchase Programs, while cash provided in 2022 was primarily from proceeds of the First and Second 2021 Offerings[409] Accounting Policies - The company follows U.S. GAAP for its consolidated financial statements, requiring management to make assumptions and estimates that could materially affect reported financial results[410] - Research and Development (R&D) expenses are expensed as incurred, including costs for acquiring technologies with no alternative future use[412] - Stock-based compensation is measured and recognized according to ASC 718, impacting the compensation expense for stock-based awards made to employees[413] - Basic net income (loss) per share is calculated using the weighted-average number of shares outstanding, with potentially dilutive stock options excluded from the diluted calculation due to anti-dilutive effects[414] - No new accounting pronouncements were disclosed in the company's consolidated financial statements for the current and prior year[415] - The company is classified as a smaller reporting company and is not required to provide additional market risk disclosures[416]

Product Development - The company is focused on developing cellular therapies for cancer, diabetes, and malignant ascites using its proprietary "Cell-in-a-Box" technology[140] - The current product candidate is referred to as "CypCaps™" and is intended for use in various cancer therapies, including LAPC[140] - The company is developing therapies for Type 1 diabetes using encapsulated genetically modified insulin-producing cells[144] - The encapsulation technology has shown potential in laboratory settings to create a micro-environment for cell survival and production of active molecules[141] - The company is also exploring therapies for malignant ascites using the same encapsulated cells employed for pancreatic cancer[143] Regulatory Challenges - Due to a clinical hold placed by the FDA on the IND for LAPC, the company is facing delays and increased costs in its development efforts[135] - The FDA has requested additional data and studies to lift the clinical hold, including genetic stability studies and compatibility assessments of delivery devices[149] - The company is conducting various studies requested by the FDA, including biocompatibility studies and stability studies for its product candidate for pancreatic cancer[154] - The company has retained Biologics Consulting for regulatory expertise and gap analysis to assist with IND resubmission[153] Financial Performance - The company reported no revenues for the three and nine months ended January 31, 2023, and 2022[159] - Total operating expenses for the three months ended January 31, 2023, increased by $696,864 to $1,552,983 from $856,119 in the same period of 2022[160] - Research and Development (R&D) expenses decreased by 71% to $45,393 for the three months ended January 31, 2023, compared to $158,039 in 2022[161] - Director fees increased by 838% to $795,969 for the three months ended January 31, 2023, from $84,897 in the same period of 2022[161] - Other income, net, for the three months ended January 31, 2023, was $788,847, compared to other expense, net of $44,829 for the same period in 2022[164] - Interest income for the nine months ended January 31, 2023, was $1,214,562, up from $71,078 in the same period of 2022[165] - Total operating expenses for the nine months ended January 31, 2023, increased by $2,667,898 to $5,552,211 from $2,884,313 in the same period of 2022[160] - General and administrative, legal, and professional expenses increased by 125% to $3,238,824 for the nine months ended January 31, 2023, compared to $1,437,324 in 2022[163] Cash Flow and Liquidity - Net cash used in operating activities for the nine months ended January 31, 2023, was approximately $3.5 million, compared to $2.9 million for the same period in 2022[167] - Cash and cash equivalents as of January 31, 2023, totaled approximately $73 million, down from approximately $87 million as of January 31, 2022[172] - The company reported a net cash used in financing activities of approximately $9.3 million, primarily due to the repurchase of common stock[171] - The increase in operating expenses was approximately $3.5 million, contributing to the decrease in cash[172] - The company had no investing activities for the nine months ended January 31, 2023, and 2022[170] - The company expects to use existing cash balances and may consider additional debt or equity issuances to meet liquidity needs[179] - Total estimated cost for service agreements related to clinical hold is approximately $214,000, with $157,000 attributed to related parties[180] - The company received gross proceeds of approximately $70 million from a registered direct offering and concurrent private placement in August 2021[175] - The company reported a net increase (decrease) in cash and cash equivalents of approximately $(12.76) million for the nine months ended January 31, 2023[172] - The company has a history of operating losses, which may affect its ability to raise capital on acceptable terms[179] Strategic Initiatives - The company has entered into a Cooperation Agreement with Iroquois Master Fund Ltd. to reconstitute its Board and evaluate its business strategy[140] - The company has curtailed spending on its development programs pending the completion of a review by the Business Review Committee[147] - The company is not currently allocating resources to its Cannabis Program until it receives FDA approval for its LAPC clinical trial[145]

Product Development - The company is focused on developing cellular therapies for cancer, diabetes, and malignant ascites using its proprietary "Cell-in-a-Box" technology[135]. - The current product candidate is referred to as "CypCaps™" and is intended for use in therapies for several types of cancer, including LAPC[135]. - The company is currently conducting a pilot study involving two pigs to evaluate the safety and activity of its product candidate for pancreatic cancer[145]. - The encapsulation technology aims to protect genetically engineered live human cells, enhancing their survival and efficacy in producing active molecules[136]. - The company is also developing therapies for Type 1 diabetes using encapsulated genetically modified insulin-producing cells[139]. Regulatory Challenges - Due to a clinical hold placed by the FDA on the IND for LAPC, the company is facing delays and increased costs in its development efforts[131]. - The FDA has requested additional data and studies to lift the clinical hold, including genetic stability studies and a biocompatibility assessment[144]. - The company is currently addressing various regulatory requirements to lift the clinical hold on its IND for the planned clinical trial in LAPC[152]. Financial Performance - The total operating expenses for the three months ended October 31, 2022, increased by $1,313,777 to $2,318,620 from $1,004,843 in the same period in 2021, primarily due to increases in R&D costs, compensation, legal, and consulting expenses[155]. - R&D expenses for the three months ended October 31, 2022, were $177,996, reflecting a 32% increase from $135,220 in the same period in 2021[156]. - Compensation expenses for the three months ended October 31, 2022, were $400,420, a 51% increase from $265,012 in the same period in 2021[156]. - The total operating expenses for the six months ended October 31, 2022, increased by $1,971,034 to $3,999,228 from $2,028,194 in the same period in 2021[157]. - R&D expenses for the six months ended October 31, 2022, were $337,269, a 21% increase from $278,833 in the same period in 2021[158]. - Compensation expenses for the six months ended October 31, 2022, were $728,138, a 36% increase from $533,897 in the same period in 2021[158]. - General and administrative, legal, and professional expenses for the three months ended October 31, 2022, were $1,637,869, representing a 201% increase from $543,557 in the same period in 2021[156]. - General and administrative, legal, and professional expenses for the six months ended October 31, 2022, were $2,778,759, a 155% increase from $1,091,251 in the same period in 2021[158]. - The company had no revenues for the three and six months ended October 31, 2022, and 2021[154]. Cash Flow and Liquidity - Net cash used in operating activities for the six months ended October 31, 2022, was $(2,963,642), compared to $(2,626,834) for the same period in 2021, indicating an increase in operational losses[162]. - Cash and cash equivalents as of October 31, 2022, totaled approximately $77 million, down from approximately $87 million as of October 31, 2021, primarily due to increased operating expenses and stock repurchase[165]. - The cash used in financing activities for the six months ended October 31, 2022, was approximately $(5.5 million) due to the repurchase of common stock[164]. - The company expects to use existing cash balances and may consider additional debt or equity issuances to meet liquidity needs, given the history of operating losses[171]. - The total cost of service agreements related to the clinical hold on the IND submission involving LAPC is estimated to be approximately $347,000, with a significant portion allocated to related parties[172]. - The company had no investing activities for the six months ended October 31, 2022, and 2021, indicating a focus on operational rather than investment expenditures[163]. - The company received gross proceeds of approximately $70 million from the Second Offering in August 2021, contributing to its capital resources[168]. - The company reported a net increase (decrease) in cash and cash equivalents of $(8,438,069) for the six months ended October 31, 2022, compared to an increase of $84,736,506 in the same period of 2021[162]. - The company has no off-balance sheet arrangements that could materially affect its financial condition, revenues, or expenses[170]. Corporate Governance - The company has entered into a Cooperation Agreement with Iroquois Master Fund Ltd. to reconstitute its Board and evaluate its business strategy[135]. - Spending on development programs has been curtailed pending the completion of the Business Review Committee's evaluation[142]. - The company is exploring new frameworks for its relationship with SG Austria, which may impact its development programs[135].

Company Focus and Product Development - The company is focused on developing cellular therapies for cancer, diabetes, and malignant ascites using its proprietary "Cell-in-a-Box" technology [133]. - The current product candidate, "CypCaps™," is designed to encapsulate genetically engineered live human cells for therapeutic applications [133]. - The company is exploring therapies for Type 1 diabetes using encapsulated insulin-producing cells as a bio-artificial pancreas [137]. - The company is also developing therapies for malignant ascites using encapsulated cells administered in the peritoneal cavity [136]. Regulatory and Clinical Trials - Due to a clinical hold placed by the FDA on the IND for a planned trial in LAPC, the company is facing delays and increased costs in its development efforts [129]. - The FDA has requested additional studies and data to lift the clinical hold, including stability studies and compatibility assessments of delivery devices [142]. - The company is currently conducting 10 biocompatibility studies requested by the FDA, with 8 completed successfully [146]. - A pig study has commenced to evaluate biocompatibility and long-term implantation of CypCaps™, with the first phase completed and preliminary data being evaluated [150]. - The company is facing potential delays in clinical trials due to COVID-19, impacting patient enrollment and site activation [149]. Financial Performance - The company reported no revenues for the three months ended July 31, 2022, consistent with the same period in 2021 [157]. - Total operating expenses increased by $657,257 to $1,680,608 for the three months ended July 31, 2022, compared to $1,023,351 in the same period in 2021 [158]. - Research and Development (R&D) expenses rose to $159,273, an increase of 11% from $143,613 in the prior year [159]. - Compensation expenses increased by 22% to $327,718 from $268,885 in the previous year [159]. - General and administrative, legal, and professional expenses surged by 108% to $1,140,890, up from $547,694 in the same period last year [159]. - Loss from operations increased by $657,257 to $1,680,608 for the three months ended July 31, 2022, primarily due to increased R&D and legal expenses [160]. - Other income for the three months ended July 31, 2022, was $135,596, compared to a net expense of $2,067 in the same period in 2021, driven by interest income of $139,502 [161]. Cash Flow and Funding - Net cash used in operating activities for the three months ended July 31, 2022, was $1,084,378, a decrease from $1,241,221 in the same period of 2021 [163]. - Cash and cash equivalents as of July 31, 2022, totaled approximately $82.2 million, up from approximately $959,000 as of July 31, 2021 [166]. - Working capital increased to approximately $81.2 million as of July 31, 2022, compared to approximately $583,000 as of July 31, 2021 [166]. - Cash used in financing activities for the three months ended July 31, 2022, was $2,089,967, primarily due to the repurchase of common stock [165]. - The company raised approximately $70 million from the Second Offering, which included shares of common stock and warrants [169]. - Total funding of approximately $87.4 million was provided by investors through the First Offering, Second Offering, and Warrant Exercises to support operations and R&D [170]. - The company reported a decrease in cash of $3,173,041 for the three months ended July 31, 2022, compared to a decrease of $1,242,836 in the same period of 2021 [163]. - The company had no investing activities for the three months ended July 31, 2022, and 2021 [164]. Intellectual Property and Business Strategy - The expiration of patents covering the Cell-in-a-Box technology raises concerns about the company's ability to protect its intellectual property [131]. - The company has entered a Cooperation Agreement with Iroquois Master Fund Ltd. to reconstitute its Board of Directors and review its business strategy [133]. - The company is under review by its Business Review Committee regarding spending on programs dependent on SG Austria and Austrianova [171]. - The total estimated cost for service agreements related to the clinical hold on the IND submission involving LAPC is approximately $373,000 [173].

Financial Position - As of April 30, 2022, the company's cash and cash equivalents totaled approximately $85.4 million, a significant increase from approximately $2.2 million as of April 30, 2021[456]. - The company raised approximately $87.4 million during the year ended April 30, 2022, through various offerings and warrant exercises[460]. - The company experienced an increase in cash of $83,198,550 for the year ended April 30, 2022, compared to an increase of $1,307,245 in 2021[469]. - Net cash provided by financing activities for the year ended April 30, 2022, was $87,311,244, significantly higher than $4,636,807 in 2021[469]. - The effect of currency rate exchange contributed $4,625 to cash flow for the year ended April 30, 2022, compared to $1,327 in 2021[469]. Operating Expenses - The total operating expenses for the year ended April 30, 2022, increased by $769,033 to $4,392,014 from $3,622,981 in the previous year, primarily due to increases in compensation, legal, and professional expenses[464]. - Operating expenses for R&D decreased by 25% to $690,937 in 2022 from $916,249 in 2021[465]. - Compensation expenses increased by 8% to $1,544,751 in 2022 from $1,429,150 in 2021[465]. - Research and development expenses are expensed as incurred, with costs for acquiring technologies utilized in R&D also expensed immediately[475]. Revenue and Income - The company reported no revenues for the fiscal years ended April 30, 2022, and 2021[463]. - Other income for the year ended April 30, 2022, was $152,853, compared to a net expense of $71,745 for the year ended April 30, 2021, primarily due to interest income of $157,645[467]. Clinical Trials and Research - The company is preparing for a Phase 2b clinical trial in LAPC, which has been placed on clinical hold by the FDA[442][443]. - The company has developed a potential therapy for Type 1 diabetes using encapsulated genetically modified insulin-producing cells[446]. - The company is exploring the use of its Cell-in-a-Box technology for therapies involving prodrugs based on constituents of the Cannabis plant, pending FDA approval[445]. - The company faces potential delays in clinical trials due to COVID-19, impacting various operational aspects including patient enrollment and supply chain[450][451]. Financial Reporting - Basic net loss per share for the year ended April 30, 2022, was calculated using the weighted-average number of shares outstanding, with potentially dilutive stock options excluded due to anti-dilutive effects[477]. - The company follows U.S. GAAP for financial reporting, requiring management to make estimates and judgments that could materially affect reported financial results[473]. Investing Activities - The company had no investing activities for the years ended April 30, 2022, and 2021[471].

Product Development - The company is focused on developing cellular therapies for cancer and diabetes using its proprietary Cell-in-a-Box technology[139]. - The current product candidate, CypCaps™, is intended for a Phase 2b clinical trial in locally advanced pancreatic cancer (LAPC) but is currently on clinical hold by the FDA since October 1, 2020[139][148]. - The company is also developing a potential therapy for Type 1 diabetes using encapsulated insulin-producing cells[144]. - The encapsulation technology aims to optimize the delivery of cancer prodrugs directly to tumors, potentially improving treatment efficacy[142]. - The company is exploring the development of therapies involving cannabinoids for cancer treatment, pending the resolution of the clinical hold[145]. - The company is developing a protocol to measure the break and glide force of syringes used in clinical trials[153]. - A pig study has been designed to address biocompatibility and long-term implantation of CypCaps™[153]. Regulatory and Clinical Trials - The FDA has requested several additional studies and information to lift the clinical hold, including stability studies and genetic stability assessments[150]. - The company has completed a product stability study for CypCaps™ after 3, 6, 9, 12, and 18 months of storage at -80C, with the next analysis scheduled for 24 months[151]. - Six out of eight biocompatibility studies have been successfully completed, with ongoing studies to assess the safety of the product candidate[151]. - The COVID-19 pandemic has caused significant delays in clinical trials, impacting the company's operations and the timeline for addressing the FDA's clinical hold[152]. - The company has retained Biologics Consulting to assist with regulatory compliance and to perform a regulatory gap analysis[151]. Financial Performance - No revenues were reported for the three and nine months ended January 31, 2022, and 2021[157]. - Total operating expenses for the three months ended January 31, 2022, increased by $99,272 compared to the same period in 2021, primarily due to a $93,022 increase in R&D expenses[158]. - Total operating expenses for the nine months ended January 31, 2022, increased by $296,275 from the same period in 2021, with R&D expenses rising by $205,031[160]. - Net cash used in operating activities for the nine months ended January 31, 2022, was $2,925,479, compared to $2,390,586 for the same period in 2021[163]. - Cash provided by financing activities for the nine months ended January 31, 2022, was $87,362,049, significantly higher than $4,586,002 in the same period in 2021[163]. - As of January 31, 2022, cash totaled approximately $86.6 million, up from approximately $3.1 million as of January 31, 2021[168]. - Working capital was approximately $87 million as of January 31, 2022, compared to approximately $2.5 million as of January 31, 2021[168]. - Funding of approximately $86.2 million was provided by investors during the nine months ended January 31, 2022, to support operations and R&D[169].

Table of Contents UNITED STATES SECURITIES AND EXCHANGE COMMISSION WASHINGTON, D.C. 20549 FORM 10-Q x QUARTERLY REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the quarterly period ended October 31, 2021 or o TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the transition period from __________ to __________ Commission file number 001-40699 PHARMACYTE BIOTECH, INC. (Exact name of registrant as specified in its charter) (State or o ...

Clinical Development - The company is focused on developing cellular therapies for cancer and diabetes using its proprietary Cell-in-a-Box technology[119]. - The Investigational New Drug Application (IND) for a planned Phase 2b clinical trial in locally advanced, inoperable, non-metastatic pancreatic cancer (LAPC) was submitted on September 1, 2020, but has been placed on clinical hold by the FDA[126][127]. - The FDA has requested additional studies and information, including genetic stability studies and a stability study on the final formulated drug product[128]. - The company is conducting a 3, 6, 9, and 12-month product stability study of its clinical trial product (CypCaps), with the next time point at 18 months[130]. - The company is exploring therapies for Type 1 diabetes and insulin-dependent Type 2 diabetes using encapsulated genetically modified insulin-producing cells[123]. - The COVID-19 pandemic has caused significant delays in clinical trials and has impacted the company's operations, particularly in preparing responses to the FDA's clinical hold[131][132]. - The company is in the process of updating its IND submission documents to include more pre-clinical data and additional parameters for the release of CypCaps[133]. - The company is conducting biocompatibility studies to demonstrate the safety and efficacy of CypCaps during delivery and use[130]. - The company has designed an abbreviated study in pigs to address biocompatibility and long-term implantation of the capsules, complementing previous human clinical trial data[133]. - The company is considering developing therapies for cancer involving prodrugs based on certain constituents of the Cannabis plant, but will not allocate resources until the clinical hold is lifted[125]. Financial Performance - The company reported no revenues for the three months ended July 31, 2021, consistent with the same period in 2020[138]. - Total operating expenses increased by $141,675 to $1,023,351 for the three months ended July 31, 2021, primarily due to a rise in general and administrative expenses[140]. - Net cash used in operating activities was $1,241,221 for the three months ended July 31, 2021, compared to $551,002 in the same period of 2020[143]. - As of July 31, 2021, the company's cash totaled approximately $959,000, down from approximately $2,167,000 at July 31, 2020[147]. - The company had no investing activities for the three months ended July 31, 2021 and 2020[145]. - The company plans to incur approximately $250,000 in costs related to service agreements for clinical trial preparations, with $162,000 allocated to related parties[150]. - The company experienced a decrease in total other expenses by $201, with interest expense increasing by $79 and income taxes rising by $800[142]. - The company had a working capital of approximately $583,000 as of July 31, 2021, down from approximately $1,116,000 at July 31, 2020[147]. - The company did not receive any funding from investors during the three months ended July 31, 2021, unlike the previous year when it raised funds through stock sales[148]. Risks and Challenges - The continuation of the COVID-19 pandemic poses risks to the company's clinical development program and overall operations, potentially affecting funding and supply chains[135].

Financial Performance - The company has not generated any revenues and has accumulated a deficit of $107,409,493 as of April 30, 2021[541]. - The net loss for the year ended April 30, 2021, was $3,551,236, compared to a net loss of $3,826,888 for the year ended April 30, 2020[541]. - The total operating expenses for the year ended April 30, 2021 decreased by $203,414 to $3,622,981 from $3,826,395 in the previous year, primarily due to reduced compensation and consulting expenses[555]. - Research and Development (R&D) expenses increased by 204% to $916,249 in the year ended April 30, 2021, compared to $615,028 in the previous year[556]. - The company reported a net cash used in operating activities of $3,330,889 for the year ended April 30, 2021, compared to $2,338,373 in the previous year[561]. - The company had no revenues for the fiscal years ended April 30, 2021 and 2020[554]. - Other income for the year ended April 30, 2021 was $71,745, attributed to the forgiveness of a Paycheck Protection Program loan[559]. - The cash provided by financing activities increased to $4,636,807 in the year ended April 30, 2021, up from $2,725,848 in the previous year[561]. - The company expects to incur substantial and increasing losses in future periods as it continues its development activities[541]. - The company has not realized material revenue since commencing operations as a biotechnology company, with no assurance of future revenue generation[548]. Cash Position - Total cash in the bank was $2,202,106 as of April 30, 2021, compared to $894,861 as of April 30, 2020[541]. - As of April 30, 2021, the company had approximately $2,202,000 in cash, with cash expenditures of about $200,000 per month[549]. Capital and Financing - The company sold approximately 462,000 shares of common stock from May 1, 2020, to April 30, 2021, resulting in gross proceeds of approximately $4.7 million[547]. - The company incurred fees of approximately $472,000 related to the sale of shares under the Aeon Agreement[547]. - The company entered into an underwriting agreement for a public offering expected to raise gross proceeds of $15 million[552]. - The company is dependent on outside capital to fund its operations and may need to modify or abandon business plans if additional capital is not obtained[550]. Clinical Development - The company is preparing for a Phase 2b clinical trial in LAPC, but the FDA has placed the IND on clinical hold[527]. - The company has assembled a team of regulatory and scientific experts to address the FDA's clinical hold requirements[528]. - The company plans to develop therapies for cancer using its Cell-in-a-Box technology, including prodrugs based on cannabinoids[529]. - The company is developing a potential therapy for Type 1 and insulin-dependent Type 2 diabetes using encapsulated genetically modified insulin-producing cells[531].