FORM 10-Q Table of Contents UNITED STATES SECURITIES AND EXCHANGE COMMISSION WASHINGTON, D.C. 20549 ☒ QUARTERLY REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the quarterly period ended October 31, 2025 or ☐ TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the transition period from __________ to __________ Commission file number 001-40699 PHARMACYTE BIOTECH, INC. (Exact name of registrant as specified in its charter) (State or o ...

Group 1: Autodesk Inc - Autodesk reported third-quarter revenue of $1.85 billion, an 18% increase year-over-year, surpassing analyst estimates of $1.81 billion [1] - The company achieved adjusted earnings of $2.67 per share, exceeding estimates of $2.50 per share [1] - Following the earnings report, Autodesk shares surged 6.1% to $312.50 in pre-market trading [1] Group 2: Other Stocks in Pre-Market Trading - Mobile-Health Network Solutions saw a 45.4% increase to $2.76 after filing to increase its at-the-market offering capacity to $2.26 million from $1.25 million [5] - Inno Holdings Inc rose 29.5% to $0.35 after signing a memorandum of understanding with Megabyte Solutions for Web3 technology applications [5] - KALA BIO Inc gained 24.1% to $0.79 after entering a Securities Purchase Agreement to raise up to $6 million [5] - Urban Outfitters Inc rose 17.4% to $80.19 after reporting third-quarter EPS and sales above analyst estimates [5] - Nutanix Inc tumbled 16.8% to $48.86 after reporting worse-than-expected first-quarter results and cutting FY26 sales guidance [5] - Zscaler Inc fell 7.2% to $269.00 following the release of its first-quarter financial results [5]

Table of Contents UNITED STATES SECURITIES AND EXCHANGE COMMISSION WASHINGTON, D.C. 20549 FORM 10-Q ☒ QUARTERLY REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the quarterly period ended July 31, 2025 or PHARMACYTE BIOTECH, INC. (Exact name of registrant as specified in its charter) (State or other jurisdiction of incorporation or organization) (I.R.S. Employer Identification No.) ☐ TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For ...

Financial Performance - The company reported no revenues for the three and nine months ended January 31, 2025, and 2024 [120]. - Total operating expenses for the three months ended January 31, 2025, were $960,252, a decrease of $908,694 (approximately 48%) compared to the same period in 2024 [121]. - For the nine months ended January 31, 2025, total operating expenses were $3,335,998, a decrease of $2,017,794 (approximately 38%) compared to the same period in 2024 [123]. - Other income (expenses), net, for the three months ended January 31, 2025, was $(2,085,076), a significant decline from $1,249,490 in the same period in 2024 [125]. - Other income (expenses), net, for the nine months ended January 31, 2025, was $22,242,466, an increase of $17,901,612 (approximately 413%) compared to $4,340,854 in the same period in 2024 [126]. - Net cash used in operating activities for the nine months ended January 31, 2025, was $(1,937,925), compared to $(1,818,499) in the same period in 2024 [129]. - Cash and cash equivalents as of January 31, 2025, totaled approximately $16.4 million, down from approximately $50 million as of April 30, 2024 [134]. - Cash used in financing activities for the nine months ended January 31, 2025, was $(24,857,608), a significant increase compared to $(11,039) in the same period in 2024 [129]. Research and Development - The company is focused on developing cellular therapies for cancer using its proprietary Cell-in-a-Box® technology, specifically targeting locally advanced, inoperable, non-metastatic pancreatic cancer (LAPC) [110]. - The company has curtailed spending on development programs until the Strategic Scientific Committee completes its evaluation and a new framework for the relationship with SG Austria is established [111]. - The FDA placed the company's Investigational New Drug Application (IND) on clinical hold, requiring additional studies and data before lifting the hold [115]. - The company has successfully completed various stability studies and additional studies requested by the FDA, including biocompatibility studies [117]. - The company is in the process of providing data to the FDA to resolve non-clinical issues and enable review of a new clinical protocol for LAPC [117]. - The company has determined that it will no longer pursue research and development in the treatment of diabetes [110]. - The Strategic Scientific Committee is reviewing risks associated with the company's development programs and its relationship with SG Austria [111]. - The company aims to ensure completion of production of encapsulated cells according to cGMP regulations for the planned clinical trial [118]. - The company is actively working to minimize risks regarding success and aims to provide accurate information to shareholders [119]. Investments and Financial Instruments - The company invested $7 million in TNF Pharmaceuticals, Inc. during the nine months ended January 31, 2025 [131]. - The total cost of service agreements related to the clinical hold on the IND submission is estimated to be approximately $212,000 [137]. - The Company accounts for its convertible note receivable at fair value, with subsequent changes recorded as non-operating income (loss) in the financial statements [142]. - The fair value of the convertible note receivable is estimated using inputs such as the fair value of the debtor's common stock, equity volatility, and the risk-free interest rate [142]. - The investment in preferred stock is classified as a Variable Interest Entity (VIE), but the Company is not the primary beneficiary [143]. - Changes in the fair value of the preferred stock are recognized in earnings at each reporting period, with initial fair value estimated using a Monte Carlo simulation [143]. - The warrants are recorded at fair value, with changes recognized in earnings, and the initial fair value determined using the Black Scholes Merton Method [144]. - A gain on investment was recognized for the excess of the fair value of the warrants over the investment amount [144]. Accounting Policies - The Company tests indefinite-lived intangible assets for impairment, assessing qualitative factors to determine the likelihood of impairment [145]. - If impairment is likely, the fair value of the asset is calculated, and an impairment charge is recorded if the carrying amount exceeds fair value [145]. - Recent accounting pronouncements are discussed in the "Summary of Significant Accounting Policies" section of the Quarterly Report [146]. - The Company’s filings, including Annual Reports and Quarterly Reports, are available on its website and the SEC's website [147].

Financial Performance - Net loss for the three months ended October 31, 2024, was $1,469,560 compared to a net income of $2,789,896 for the same period in 2023[17]. - The company reported a comprehensive loss of $(1,469,499) for the three months ended October 31, 2024, compared to a comprehensive income of $2,788,305 for the same period in 2023[18]. - The company reported net cash used in operating activities of $(1,428,032) for the six months ended October 31, 2023, compared to $(1,641,395) in the prior period[28]. - Net income for the six months ended October 31, 2023, was $21,951,795, compared to a net loss of $(393,401) in the prior period[28]. - The company reported a net loss attributable to common stockholders of $2,958,875 for the three months ended October 31, 2024, compared to a net loss of $2,258,087 for the same period in 2023[90]. - For the six months ended October 31, 2024, the Company achieved a net income of $21,951,795, contrasting with a net loss of $393,401 for the same period in 2023[92]. Assets and Liabilities - Total current assets decreased from $50,439,768 in April 2024 to $21,333,269 in October 2024, a decline of approximately 58.7%[13]. - Total liabilities decreased significantly from $20,389,264 in April 2024 to $11,647,238 in October 2024, representing a reduction of about 42.9%[13]. - Cash and cash equivalents decreased from approximately $50.2 million at April 30, 2024, to $20.8 million as of October 31, 2024[45]. - Working capital was approximately $17 million as of October 31, 2024, compared to approximately $43 million as of April 30, 2024[175]. Stockholder Equity - Total stockholders' equity increased from $27,647,603 in April 2024 to $43,451,146 in October 2024, an increase of approximately 57.1%[13]. - As of October 31, 2023, total stockholders' equity stands at $36,767,508, reflecting a net loss of $3,183,297 for the period[21]. - The company issued 35,000 shares of Series B Preferred Stock, resulting in an increase of $16,753,075 in preferred stock equity[21]. - The total stockholders' equity increased to $47,708,370 by July 31, 2024, indicating positive financial momentum[24]. Expenses - Total operating expenses for the three months ended October 31, 2024, were $1,106,060, down from $1,409,520 in the same period of 2023, a decrease of about 21.5%[17]. - Total operating expenses for the six months ended October 31, 2024, were $2,374,947, a decrease of 31.8% compared to the same period in 2023[162]. - The company reported interest income of $382,562 for the three months ended October 31, 2024, compared to $894,181 for the same period in 2023, a decline of approximately 57.3%[17]. - Other income (expenses), net for the three months ended October 31, 2024, was $(363,500), a significant decline from $4,199,416 in the same period in 2023[165]. - Other income (expenses), net for the six months ended October 31, 2024, was $24,326,742, compared to $3,091,445 for the same period in 2023[166]. Research and Development - Research and development costs increased to $97,470 for the three months ended October 31, 2024, up from $82,033 in the same period of 2023, reflecting a growth of approximately 18.2%[17]. - The company is focused on developing therapies for locally advanced, inoperable pancreatic cancer using its proprietary Cell-in-a-Box technology[31]. - The FDA placed the company's Investigational New Drug Application on clinical hold, requiring additional preclinical studies and data submissions[32][39]. - The company has curtailed spending on its programs pending the completion of a review by the Business Review Committee and the Board[34][38]. Capital and Financing - The company may need to raise additional capital to support ongoing and future projects, which could be dilutive to current stockholders[46]. - The Company entered into a Securities Purchase Agreement to purchase $5,000,000 in senior unsecured convertible notes from Femasys, convertible at a price of $1.18 per share[57]. - The company invested $7 million in preferred stock and warrants during the six months ended October 31, 2023[28]. - The company invested $7 million in TNF Pharmaceuticals, Inc. for acquiring shares and warrants[171]. Legal and Regulatory Matters - The company is currently involved in a legal proceeding with H.C. Wainwright & Co., LLC, seeking damages of not less than $1,950,000[200]. - The Company intends to vigorously defend against a breach of contract complaint filed by H.C. Wainwright, seeking damages of not less than $1,950,000[77]. - The FDA has placed the Company's IND on clinical hold since October 1, 2020, requiring additional studies and data to lift the hold[139]. Internal Controls and Compliance - The company identified two material weaknesses in its internal controls: insufficient segregation of duties and insufficient management review controls[195]. - The company’s disclosure controls and procedures were found to be ineffective as of October 31, 2024, due to material weaknesses in internal control over financial reporting[191]. - The company has determined that its investment in preferred stock is a Variable Interest Entity (VIE) but is not the primary beneficiary[184]. Miscellaneous - The company has not issued any shares during the three months ended October 31, 2024[203]. - The company has curtailed spending on development programs until the Strategic Scientific Committee completes its evaluation of its programs[134]. - The fair value of the company's convertible preferred stock and warrants is estimated using models that incorporate various market assumptions, including equity volatility and risk-free interest rates[182][185].

Financial Performance - Net income for the three months ended July 31, 2024, was $23,421,355, compared to a net loss of $3,183,297 for the same period in 2023, indicating a significant turnaround[9]. - Basic and diluted income per share for the three months ended July 31, 2024, was $1.90, compared to a loss of $0.54 per share in the prior year[9]. - Total operating expenses decreased to $1,268,887 for the three months ended July 31, 2024, down from $2,075,326 in the same period of 2023, a reduction of approximately 38.9%[9]. - Other income for the three months ended July 31, 2024, was $24,690,242, a significant increase from a loss of $(1,107,971) in the same period in 2023[121]. - For the three months ended July 31, 2024, the company reported no revenues, consistent with the same period in 2023[119]. Assets and Liabilities - Total assets increased to $70,194,434 as of July 31, 2024, up from $59,903,883 on April 30, 2024, representing a growth of approximately 17.7%[7]. - Total liabilities decreased to $17,152,950 as of July 31, 2024, down from $20,389,264 on April 30, 2024, a reduction of approximately 15.0%[7]. - The accumulated deficit improved to $(92,203,655) as of July 31, 2024, from $(115,625,010) on April 30, 2024, reflecting a positive change in financial health[7]. - The total stockholders' equity increased to $47,708,370 as of July 31, 2024, compared to $27,647,603 on April 30, 2024, representing an increase of approximately 72.5%[7]. Cash Flow - Cash and cash equivalents decreased to $32,635,092 as of July 31, 2024, from $50,179,968 on April 30, 2024, a decline of about 35.0%[7]. - The company reported cash and cash equivalents of $32,635,092 at the end of the period, down from $74,662,527 at the beginning of the period, reflecting a decrease of $17,544,876[15]. - Cash used in operating activities for the three months ended July 31, 2024, was $(373,297), compared to cash provided of $342,959 in the same period in 2023[125]. - Cash used in financing activities for the three months ended July 31, 2024, was $(10,171,762), compared to cash provided of $6,279,181 in the same period in 2023[125]. - The company expects its current cash and cash equivalents of approximately $26 million will be sufficient to support projected operating requirements for at least the next twelve months[28]. Investments and Stock Repurchase - The company invested $7,000,000 in preferred stock and warrants during the period[15]. - The company repurchased common stock for $742,179, compared to $26,457,324 in the same period last year[15]. - The Company repurchased 320,346 shares at a total cost of $749,600 during the three months ended July 31, 2024, bringing total repurchases to 5,868,921 shares at a cost of $16,067,918[75]. - The tender offer completed on June 9, 2023, resulted in the purchase of 8,085,879 shares at $3.25 per share, totaling $26,721,897[76]. - The Company has $3,932,081 remaining available for share repurchases under its authorized programs as of July 31, 2024[75]. Clinical Development and FDA Compliance - The company is focused on developing cellular therapies for cancer using its proprietary Cell-in-a-Box technology, specifically targeting locally advanced, inoperable pancreatic cancer[16]. - The company is currently addressing a clinical hold from the FDA regarding its Investigational New Drug Application for a planned clinical trial in LAPC[17]. - The company aims to lift the clinical hold on its IND to commence its planned clinical trial in LAPC, contingent upon fulfilling FDA requirements[116]. - The company is actively working to ensure compliance with all FDA requirements to facilitate the timely progression of its clinical trials[116]. - The company has successfully completed stability studies for its product candidate, confirming its stability over 24 months at -80°C[107]. Legal Matters - A legal complaint was filed against the company seeking damages of not less than $1,950,000 related to a breach of contract regarding a private placement transaction[151]. - The company does not believe that the outcome of any pending legal claims will have a material adverse effect on its financial condition or operating results[150]. - The company intends to vigorously defend against the legal complaint filed by H.C. Wainwright & Co., LLC[151]. Strategic Initiatives - A Business Review Committee has been formed to evaluate the company's strategy and operations, which may lead to a reevaluation of its relationship with SG Austria[18]. - The company has curtailed spending on its programs pending the completion of the Business Review Committee's evaluation[21]. - The Strategic Scientific Committee has been formed to review risks associated with the company's development programs and to recommend future actions[100]. - The company has determined that it will no longer pursue research and development in diabetes treatment, refocusing its efforts on cancer therapies[99]. Stock Options and Compensation - As of July 31, 2024, the Company had 924,830 outstanding stock options, with a weighted average exercise price of $2.95[43]. - The Company recorded $222,677 of stock-based compensation related to Employee Options during the three months ended July 31, 2024, compared to $0 in the same period of 2023[46]. - The aggregate intrinsic value of outstanding options as of July 31, 2024, was $0, as all options had exercise prices above the closing stock price of $1.96[46].

Investment Risks - The company holds securities of other public companies, including Notes, MYMD Preferred Shares, Femasys Warrants, and MyMD Warrants, which may expose it to investment company classification risks under the Investment Company Act of 1940[401][405]. - The Notes are convertible at a price of $1.18 per share, and if converted when the market price is lower, the company may incur losses[402]. - The company may incur additional expenses and operational challenges if deemed an investment company under the 1940 Act, which could restrict its business activities[407][408]. Financial Position - As of April 30, 2024, the company has federal net operating loss carryforwards of approximately $57 million and state net operating losses of about $27 million, which may begin to expire in 2024[414]. Management and Operations - The company has experienced significant management changes, including a new Chief Executive Officer and Board, which could increase control risks and affect business operations[409]. - The company is highly dependent on its Chief Executive Officer and Chief Financial Officer, with only 2 full-time employees as of April 30, 2024, making recruitment and retention critical for success[411]. - The company anticipates significant growth in operations, particularly in drug development and regulatory affairs, which may strain its managerial and operational systems[416]. External Risks - The company faces risks from unfavorable global economic conditions, including potential supply chain disruptions due to geopolitical tensions and sanctions[417][419]. - The company operates globally, facing complex legal and regulatory requirements that expose it to various financial and operational risks[421].

Product Development - The company is focused on developing cellular therapies for cancer, diabetes, and malignant ascites using its proprietary "Cell-in-a-Box" technology[130]. - The current product candidate generation is referred to as "CypCaps™" and is intended for use in therapies for various cancers, including LAPC[130]. - The company is conducting a pilot study involving two pigs to assess the safety and activity of its product candidate for pancreatic cancer, with plans for a larger study involving 90 pigs[140]. - The company is developing a potential therapy for Type 1 diabetes using encapsulated genetically modified insulin-producing cells, designed to function as a bio-artificial pancreas[134][136]. - The company is exploring therapies for malignant ascites using encapsulated cells placed in the peritoneal cavity, administered with ifosfamide[133]. - The company has completed eight out of ten biocompatibility studies requested by the FDA, with ongoing studies expected to be completed soon[142]. - The company has successfully completed stability studies for its clinical trial product candidate for pancreatic cancer, confirming the product's integrity over 36 months[141]. Regulatory and Clinical Trials - The FDA placed the company's Investigational New Drug (IND) application on clinical hold on October 1, 2020, requiring additional data and studies to lift the hold[138]. - The company has curtailed spending on development programs pending a review by the Business Review Committee and the Board, which may delay timelines for addressing the FDA clinical hold[130][137]. - The total estimated cost for service agreements related to the clinical hold on the IND submission involving LAPC is approximately $332,000[162]. Financial Performance - Total operating expenses for the three months ended January 31, 2024, were $1,868,946, an increase of 20.3% compared to $1,552,983 for the same period in 2023[145]. - Research and Development (R&D) expenses increased by 179% to $126,732 for the three months ended January 31, 2024, compared to $81,339 in the same period in 2023[146]. - Compensation expenses rose by 147% to $620,777 for the three months ended January 31, 2024, compared to $369,221 in the same period in 2023[146]. - Other income for the three months ended January 31, 2024, was $1,249,409, an increase from $788,847 in the same period in 2023, primarily due to increased interest income[149]. - Net cash used in operating activities for the nine months ended January 31, 2024, was $1,818,499, a decrease from $3,505,343 in the same period in 2023[152]. - Total operating expenses for the nine months ended January 31, 2024, were $5,353,792, a decrease of 3.6% compared to $5,552,211 for the same period in 2023[145]. - Interest income for the nine months ended January 31, 2024, was $2,651,721, compared to $1,214,562 in the same period in 2023, reflecting an increase in interest rates[150]. - As of January 31, 2024, cash and cash equivalents totaled approximately $61 million, down from approximately $73 million as of January 31, 2023, indicating a decrease of about 16.4%[156]. - Working capital was approximately $62 million as of January 31, 2024, compared to approximately $68 million as of January 31, 2023, reflecting a decrease of about 8.8%[156]. - The company repurchased common stock amounting to approximately $27 million during the nine months ended January 31, 2024[156]. - The gross proceeds from the Private Placement on May 10, 2023, were $35 million, with potential additional proceeds of approximately $35 million if all Warrants are exercised[157]. - The company entered into a Purchase Agreement to acquire senior unsecured convertible notes worth $5 million, convertible at a price of $1.18 per share[159]. - The company expects to use existing cash balances and may consider additional issuances of debt or equity securities to meet liquidity needs[158]. - The Series B Preferred Stock is classified as temporary equity due to its redeemable nature upon certain contingent events[171]. - Basic net income (loss) per share is computed using the weighted-average number of shares of common stock outstanding[172]. - The company’s future capital requirements are difficult to forecast and will depend on various factors, but it believes current cash on hand will fund operating expenses for at least the next 12 months[158]. Management and Partnerships - The company is evaluating its relationship with SG Austria, which may impact the development of programs dependent on this partnership[130]. - The company has experienced significant management changes, which could increase control risks and adversely affect business operations[127]. - The company is not currently allocating resources to its Cannabis Program until the FDA allows the commencement of its clinical trial in LAPC[135].

Product Development - The company is focused on developing cellular therapies for cancer, diabetes, and malignant ascites using its proprietary "Cell-in-a-Box" technology[136] - The current product candidate is referred to as "CypCaps™" and is intended for use in treating locally advanced pancreatic cancer (LAPC)[136] - The company is exploring therapies for Type 1 diabetes using encapsulated genetically modified insulin-producing cells[140] - The company has also been developing therapies for malignant ascites using encapsulated cells placed in the peritoneal cavity[139] - The company is conducting a pig study to assess biocompatibility and long-term implantation of CypCaps™, with the first phase completed and preliminary data being evaluated[152] Regulatory and Clinical Trials - The FDA placed the company's Investigational New Drug (IND) application for LAPC on clinical hold, requiring additional data and studies to lift the hold[144] - The company is in the latter stages of conducting studies to address the FDA's requests, including genetic stability studies and compatibility evaluations of delivery devices[146] - The company completed various additional studies requested by the FDA, including a 36-month stability study on cells from the Master Cell Bank (MCB)[148] - The company has retained Biologics Consulting to perform a regulatory "Gap Analysis" to assist with the resubmission of the IND[147] - The company is in the process of updating its IND submission documentation, including discussions on immunological aspects of its treatment for LAPC[152] Financial Performance - No revenues were reported for the three and six months ended October 31, 2023 and 2022[151] - Total operating expenses for the three months ended October 31, 2023 were $1,409,520, a decrease of $909,100 (39%) compared to the same period in 2022[153] - Research and Development (R&D) expenses for the three months ended October 31, 2023 were $82,033, a decrease of $95,963 (54%) from $177,996 in 2022[154] - Other income for the three months ended October 31, 2023 was $4,199,416, significantly higher than $438,113 in the same period of 2022, primarily due to interest income[156] - Net cash used in operating activities for the six months ended October 31, 2023 was $1,641,395, an improvement from $2,963,642 in 2022[159] - Total operating expenses for the six months ended October 31, 2023 decreased by $514,382 to $3,484,846 compared to the same period in 2022[155] Cash and Capital Management - As of October 31, 2023, cash and cash equivalents totaled approximately $73 million, down from $77 million as of October 31, 2022, indicating a decrease of about 5.19% year-over-year[163] - Working capital was approximately $68 million as of October 31, 2023, compared to approximately $76 million as of October 31, 2022, reflecting a decline of about 10.53%[163] - The company repurchased common stock amounting to approximately $26.6 million during the six months ended October 31, 2023[162] - The gross proceeds from the private placement of preferred shares and warrants amounted to $35 million, with potential additional proceeds of approximately $35 million if all warrants are exercised[164] - 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[165] Corporate Governance - The company has entered into a Cooperation Agreement with Iroquois Master Fund Ltd. to reconstitute its board and form a Business Review Committee to evaluate its strategy and operations[136] - The Board is reviewing risks associated with the company's relationship with SG Austria, which may affect development timelines[136] - Spending on development programs has been curtailed pending the completion of the Business Review Committee's evaluation[143] - A service agreement was entered into for approximately $392,000 related to clearing a clinical hold on an IND submission, with $157,000 allocated to related parties[171] - The Board established a Strategic Scientific Committee to enhance oversight of scientific initiatives, with Dr. Michael Abecassis as Chair[169] - Non-employee directors were granted a cash retainer fee of $60,000 and options to purchase shares at an exercise price of $2.18 per share[167] Accounting and Compliance - The company’s financial statements are prepared in accordance with U.S. GAAP, with management regularly reviewing critical accounting estimates and policies[172]

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].