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PharmaCyte Biotech(PMCB) - 2025 Q3 - Quarterly Report
PMCBPharmaCyte Biotech(PMCB)2025-03-17 21:22

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,adecreaseof960,252, 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,adecreaseof3,335,998, 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),asignificantdeclinefrom(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,anincreaseof22,242,466, an increase of 17,901,612 (approximately 413%) compared to 4,340,854inthesameperiodin2024[126].−NetcashusedinoperatingactivitiesfortheninemonthsendedJanuary31,2025,was4,340,854 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)inthesameperiodin2024[129].−CashandcashequivalentsasofJanuary31,2025,totaledapproximately(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 50millionasofApril30,2024[134].−CashusedinfinancingactivitiesfortheninemonthsendedJanuary31,2025,was50 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)inthesameperiodin2024[129].ResearchandDevelopment−ThecompanyisfocusedondevelopingcellulartherapiesforcancerusingitsproprietaryCell−in−a−Box®technology,specificallytargetinglocallyadvanced,inoperable,non−metastaticpancreaticcancer(LAPC)[110].−ThecompanyhascurtailedspendingondevelopmentprogramsuntiltheStrategicScientificCommitteecompletesitsevaluationandanewframeworkfortherelationshipwithSGAustriaisestablished[111].−TheFDAplacedthecompany′sInvestigationalNewDrugApplication(IND)onclinicalhold,requiringadditionalstudiesanddatabeforeliftingthehold[115].−ThecompanyhassuccessfullycompletedvariousstabilitystudiesandadditionalstudiesrequestedbytheFDA,includingbiocompatibilitystudies[117].−ThecompanyisintheprocessofprovidingdatatotheFDAtoresolvenon−clinicalissuesandenablereviewofanewclinicalprotocolforLAPC[117].−Thecompanyhasdeterminedthatitwillnolongerpursueresearchanddevelopmentinthetreatmentofdiabetes[110].−TheStrategicScientificCommitteeisreviewingrisksassociatedwiththecompany′sdevelopmentprogramsanditsrelationshipwithSGAustria[111].−ThecompanyaimstoensurecompletionofproductionofencapsulatedcellsaccordingtocGMPregulationsfortheplannedclinicaltrial[118].−Thecompanyisactivelyworkingtominimizerisksregardingsuccessandaimstoprovideaccurateinformationtoshareholders[119].InvestmentsandFinancialInstruments−Thecompanyinvested(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].