年報
年度報告
10-K
2026-07-29
PharmaCyte Biotech提交10-K年報 核心胰腺癌療法仍遭FDA臨床擱置
AI 繁中摘要
PharmaCyte Biotech, Inc. 已提交截至2026年4月30日止財政年度的10-K年報。這是一家處於開發階段的生物科技公司，專注於利用其專有的「Cell-in-a-Box®」纖維素基活細胞封裝技術開發癌症細胞療法。
目前，公司的核心候選藥物CypCaps™正針對局部晚期、無法切除、非轉移性胰腺癌（LAPC）進行開發。然而，其研究性新藥申請（IND）自2020年10月起被美國FDA臨床擱置。為解除擱置，公司已應FDA要求完成多項額外研究，包括基因序列確認、遺傳穩定性、生物相容性及穩定性測試等。目前正處於與FDA溝通及準備後續步驟（如細胞封裝、推力測試）的階段，並等待FDA回應。管理層表示，可能需要進行更多臨床前研究。
🔬 業務與策略重點：
- 技術平台：利用Cell-in-a-Box®膠囊封裝經基因改造的活細胞，使其能將化療前藥轉化為抗癌活性形式，實現「標靶化療」以減少全身副作用。
- 競爭優勢：膠囊由纖維素製成，具備生物惰性、耐用且不易降解，且可冷凍保存，解凍後細胞存活率約85%。
- 市場機遇：美國每年約有67,000例新發胰腺癌病例，現有療法（如Abraxane®+gemcitabine或FOLFIRINOX）對LAPC患者效果有限，存在未滿足醫療需求。
- 董事會已成立戰略科學委員會，正重新評估與技術供應商SG Austria的關係及整體開發計劃，期間已削減研發開支。
💰 財務與股權概況：
- 截至2025年10月31日，非關聯人士持有的普通股市值約為6,278,282美元。
- 截至2026年7月24日，已發行普通股總數為10,735,649股。
- 公司依賴股權融資及合作協議支持營運，並與SG Austria訂有4%的銷售額特許權使用費條款。
⚠️ 投資者需關注的風險：
- IND臨床擱置尚未解除，無法確定何時能啟動臨床試驗。
- 所有相關專利已到期，關鍵技術知識僅由SG Austria持有，供應鏈存在依賴及流動性風險。
- 若無法獲得額外融資或與SG Austria達成新框架，研發將持續受限。
- 面臨來自大型藥廠及學術機構的激烈競爭。
- 截至報告日，公司僅有兩名全職員工，大部分工作依賴顧問。
整體而言，PharmaCyte Biotech正處於關鍵轉折點，能否解決FDA疑慮並理順與合作夥伴的關係，將直接影響其未來發展及股東價值。報告強調了持續經營能力的不確定性。
展開英文正文
PHARMACYTE BIOTECH, INC. 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0001157075 PMCB:WarrantAssetFemasysMember us-gaap:FairValueInputsLevel3Member 2025-04-30 0001157075 PMCB:InvestmentInPreferredStockQCLSMember us-gaap:FairValueInputsLevel3Member 2026-04-30 0001157075 PMCB:InvestmentInPreferredStockQCLSMember us-gaap:FairValueInputsLevel3Member 2025-04-30 0001157075 PMCB:WarrantAssetQCLSMember us-gaap:FairValueInputsLevel3Member 2026-04-30 0001157075 PMCB:WarrantAssetQCLSMember us-gaap:FairValueInputsLevel3Member 2025-04-30 iso4217:USD xbrli:shares iso4217:USD xbrli:shares xbrli:pure PMCB:Integer PMCB:Year Table of Contents UNITED STATES SECURITIES AND EXCHANGE COMMISSION WASHINGTON, D.C. 20549 FORM 10-K ☒ ANNUAL REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the fiscal year ended April 30, 2026 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) Nevada 62-1772151 (State or other jurisdiction of incorporation or organization) (I.R.S. Employer Identification No.) 3960 Howard Hughes Parkway, Suite 500 Las Vegas, NV 89169 (917) 595-2850 (Address of principal executive offices) (Registrant’s telephone number, including area code) Securities registered pursuant to Section 12(b) of the Act: Title of each class Trading symbol(s) Name of each exchange on which registered Common Stock, Par Value $0.0001 Per Share PMCB The Nasdaq Stock Market LLC Securities registered pursuant to Section 12(g) of the Act: None Indicate by check mark if the registrant is a well-known seasoned issuer, as defined in Rule 405 of the Securities Act. Yes ☐ No ☒ Indicate by check mark if the registrant is not required to file reports pursuant to Section 13 or Section 15(d) of the Act. Yes ☐ No ☒ Indicate by check mark whether the registrant (1) has filed all reports required to be filed by Section 13 or 15(d) of the Securities Exchange Act of 1934 during the preceding 12 months (or for such shorter period that the registrant was required to file such reports), and (2) has been subject to such filing requirements for the past 90 days. Yes ☒ No ☐ Indicate by check mark whether the registrant has submitted electronically every Interactive Data File required to be submitted pursuant to Rule 405 of Regulation S-T (§ 232.405 of this chapter) during the preceding 12 months (or for such shorter period that the registrant was required to submit such files). Yes ☒ No ☐ Indicate by check mark whether the registrant is a large accelerated filer, an accelerated filer, a non-accelerated filer, a smaller reporting company, or an emerging growth company. See the definitions of “large accelerated filer,” “accelerated filer,” “smaller reporting company,” and “emerging growth company” in Rule 12b-2 of the Exchange Act. Large accelerated filer ☐ Accelerated filer ☐ Non-accelerated filer ☒ Smaller reporting company ☒ Emerging growth company ☐ If an emerging growth company, indicate by check mark if the registrant has elected not to use the extended transition period for complying with any new or revised financial accounting standards provided pursuant to Section 13(a) of the Exchange Act. ☐ Indicate by check mark whether the registrant has filed a report on and attestation to its management’s assessment of the effectiveness of its internal control over financial reporting under Section 404(b) of the Sarbanes-Oxley Act (15 U.S.C. 7262(b)) by the registered public accounting firm that prepared or issued its audit report. ☐ If securities are registered pursuant to Section 12(b) of the Act, indicate by check mark whether the financial statements of the registrant included in the filing reflect the correction of an error to previously issued financial statements. ☐ Indicate by check mark whether any of those error corrections are restatements that required a recovery analysis of incentive-based compensation received by any of the registrant’s executive officers during the relevant recovery period pursuant to §240.10D-1(b). ☐ Indicate by check mark whether the registrant is a shell company (as defined in Rule 12b-2 of the Exchange Act). Yes ☐ No ☒ State the aggregate market value of the voting and non-voting common equity held by non-affiliates computed by reference to the price at which the common equity was last sold, or the average bid and asked price of such common equity, as of October 31, 2025: $6,278,282. As of July 24, 2026, the registrant had 10,735,649 outstanding shares of common stock. DOCUMENTS INCORPORATED BY REFERENCE None. TABLE OF CONTENTS PART I ITEM 1. BUSINESS 1 ITEM 1A. RISK FACTORS 30 ITEM 1B. UNRESOLVED STAFF COMMENTS 78 ITEM 1C. CYBERSECURITY 79 ITEM 2. PROPERTIES 81 ITEM 3. LEGAL PROCEEDINGS 81 ITEM 4. MINE SAFETY DISCLOSURES 81 PART II ITEM 5. MARKET FOR REGISTRANT’S COMMON EQUITY, RELATED STOCKHOLDER MATTERS AND ISSUER PURCHASES OF EQUITY SECURITIES 82 ITEM 6. [RESERVED] 82 ITEM 7. MANAGEMENT’S DISCUSSION AND ANALYSIS OF FINANCIAL CONDITION AND RESULTS OF OPERATIONS 83 ITEM 7A. QUANTITATIVE AND QUALITATIVE DISCLOSURES ABOUT MARKET RISK 92 ITEM 8. FINANCIAL STATEMENTS AND SUPPLEMENTARY DATA 92 ITEM 9. CHANGES IN AND DISAGREEMENTS WITH ACCOUNTANTS ON ACCOUNTING AND FINANCIAL DISCLOSURES 92 ITEM 9A. CONTROLS AND PROCEDURES 92 ITEM 9B. OTHER INFORMATION 94 ITEM 9C. DISCLOSURE REGARDING FOREIGN JURISDICTIONS THAT PREVENT INSPECTIONS 94 PART III ITEM 10. DIRECTORS, EXECUTIVE OFFICERS AND CORPORATE GOVERNANCE 95 ITEM 11. EXECUTIVE COMPENSATION 101 ITEM 12. SECURITY OWNERSHIP OF CERTAIN BENEFICIAL OWNERS AND MANAGEMENT AND RELATED STOCKHOLDER MATTERS 106 ITEM 13. CERTAIN RELATIONSHIPS AND RELATED TRANSACTIONS, AND DIRECTOR INDEPENDENCE 107 ITEM 14. PRINCIPAL ACCOUNTANT FEES AND SERVICES 108 PART IV ITEM 15. EXHIBITS AND FINANCIAL STATEMENT SCHEDULES 110 ITEM 16. FORM 10-K SUMMARY 114 i Cautionary Note Regarding Forward-Looking Statements This Annual Report on Form 10-K (“Report”) includes “forward-looking statements” within the meaning of the federal securities laws. Forward-looking statements are inherently subject to risks, uncertainties and assumptions. Generally, statements other than statements of historical fact are “forward-looking statements” for purposes of this Report, including any projections of earnings, revenue or other financial items, any statements regarding the plans and objectives of management for future operations, any statements concerning proposed new products or services, any statements regarding future economic conditions or performance, any statements regarding expected benefits from any transactions and any statements of assumptions underlying any of the foregoing. In some cases, forward-looking statements can be identified by use of terminology such as “may,” “will,” “should,” “believes,” “intends,” “expects,” “plans,” “anticipates,” “estimates,” “goal,” “aim,” “potential” or “continue,” or the negative thereof or other comparable terminology. Although we believe that the expectations reflected in the forward-looking statements contained in this Report are reasonable, there can be no assurance that such expectations or any of the forward-looking statements will prove to be correct, and actual results could differ materially from those projected or assumed in the forward-looking statements. Thus, investors should refer to and carefully review information in future documents we file with the U.S. Securities and Exchange Commission (“Commission”). Our future financial condition and results of operations, as well as any forward-looking statements, are subject to inherent risk and uncertainties, including, but not limited to, the risk factors set forth in “Part I, Item 1A – Risk Factors” set forth in this Report and for the reasons described elsewhere in this Report. Among others, these include: · our estimates regarding expenses, future revenues, capital requirements and needs for additional financing; · whether the United States (“U.S.”) Food and Drug Administration (“FDA”) approves our Investigational New Drug Application (“IND”) after we complete the FDA’s requested studies and submit a response to the FDA’s clinical hold, so that we can commence our planned clinical trial involving locally advanced, inoperable, non-metastatic pancreatic cancer (“LAPC”); · the success and timing of our preclinical studies and clinical trials; · the potential that results of preclinical studies and clinical trials may indicate that any of our technologies and product candidates are unsafe or ineffective; · our dependence on third parties in the conduct of our preclinical studies and clinical trials; · the difficulties and expenses associated with obtaining and maintaining regulatory approval of our product candidates; · adverse macroeconomic conditions, including inflation, rising interest rates, geopolitical instability and disruptions to the global economy or financial markets, which could materially affect our operations, our ability to raise capital, and the business or operations of third parties with whom we conduct business; and · whether the FDA will approve our product candidates after our clinical trials are completed, assuming the FDA allows our clinical trials to proceed after submission and review of our response to the FDA’s clinical hold. All forward-looking statements and reasons why results may differ included in this Report are made as of the date hereof, and we do not intend to update any forward-looking statements except as required by law or applicable regulations. New risk factors emerge from time to time, and it is not possible to predict all such risk factors, nor can we assess the impact of all such risk factors on our business or the extent to which any factor or combination of factors may cause actual results to differ materially from those contained in any forward-looking statements. Forward-looking statements are not guarantees of performance. All forward-looking statements attributable to us or persons acting on our behalf are expressly qualified in their entirety by the foregoing cautionary statements. Except where the context otherwise requires, in this Report, the “Company,” “we,” “us” and “our” refer to PharmaCyte Biotech, Inc., a Nevada corporation, and, where appropriate, its subsidiaries. ii PART I ITEM 1. BUSINESS We are a biotechnology company focused on developing cellular therapies for cancer based upon a proprietary cellulose-based live cell encapsulation technology known as “Cell-in-a-Box®.” The Cell-in-a-Box® technology is intended to be used as a platform upon which therapies for several types of cancer, including LAPC, will be developed. The current generation of our product candidate is referred to as “CypCaps™.” On November 17, 2023, the Board formed the Strategic Scientific Committee (the “Scientific Committee”), chaired by Dr. Michael Abecassis. The Scientific Committee and our independent consultants are reviewing many of the risks relative to our business. In addition, the Board is reviewing risks associated with our development programs and our relationship with SG Austria Pte. Ltd. (“SG Austria”), including that all licensed patents have expired and that know-how relating to our Cell-in-a-Box® technology solely resides with SG Austria. The Board has reduced spending on our programs, including pre-clinical and clinical activities, until the review by the Scientific Committee and the Board is complete and the Board has determined the actions and plans to be implemented. The Scientific Committee’s recommendations will include potentially seeking a new framework for our relationship with SG Austria and its subsidiaries. We are reevaluating those programs which are dependent on SG Austria and the U.S. Food and Drug Administration’s (the “FDA”) acceptance of its technologies, including our development programs for locally advanced, inoperable, non-metastatic pancreatic cancer (“LAPC”). Our reevaluation for addressing the FDA concerns has resulted in delays stemming from the review of the nonclinical package provided by SG Austria and changes to the FDA review process. The Cell-in-a-Box® encapsulation technology is designed to present genetically engineered live human cells to targeted tissues. The technology is intended to result in the formation of pinhead-sized cellulose-based porous capsules in which genetically modified live human cells can be encapsulated, grown to confluence and maintained in a cryopreserved (frozen) state until shortly before they are injected into an appropriate patient. In a laboratory setting, this proprietary live cell encapsulation technology has been shown to create a micro-environment in which encapsulated cells survive and flourish. Encapsulated cells are protected from environmental challenges, such as the shear forces associated with bioreactors and passage through catheters and needles, which we believe enables greater cell growth and production of the active molecules. The capsules are largely composed of cellulose (cotton) and are bioinert. During the past year, SG Austria has generated data and reports to support submission to the FDA concerning the safety of the microcapsules. We have been developing therapies for pancreatic tumors by using genetically engineered live human cells that we believe may be capable of converting a cancer prodrug into its cancer-killing form. We encapsulate those cells using the Cell-in-a-Box® technology and place those capsules in the body as close as possible to the tumor. In this way, we believe that when a cancer prodrug is administered to a patient with a particular type of cancer that may be affected by the resulting active drug, the killing or shrinking the patient’s cancerous tumor may be optimized both by enhanced potency and limited exposure away from the target tumor. We believe that the prodrug/activator technology is well suited to address the shift from cure/enhanced survival to creating a zone of clearance around blood vessels adjacent to tumor. This zone of clearance improves the probability of successful surgical resection of LAPC, which has been shown to improve survival. In addition to reengaging SG Austria, we are also identifying alternative approaches to expand the prodrug/activator technology for cancer treatment. These discussions may expand our prodrug/activation options to use highly toxic cancer-killing drugs in tightly controlled perivascular spaces. Until the Scientific Committee completes its evaluation of our programs and we enter into a new framework for our relationship with SG Austria, spending on our development programs has been curtailed. 1 Investigational New Drug Application and Clinical Hold On September 1, 2020, we submitted an IND to the FDA for a planned clinical trial in LAPC. On October 1, 2020, we received notice from the FDA that it had placed our IND on clinical hold. On October 30, 2020, the FDA sent us a letter setting forth the reasons for the clinical hold and providing specific guidance on what we must do to have the clinical hold lifted. In order to address the clinical hold, the FDA has requested that we: · Provide additional sequencing data and genetic stability studies; · Conduct a stability study on our final formulated product candidate as well as the cells from our Master Cell Bank (“MCB”); · Evaluate the compatibility of the delivery devices (the prefilled syringe and the microcatheter used to implant the CypCaps™) with our product candidate for pancreatic cancer; · Provide additional detailed description of the manufacturing process of our product candidate for pancreatic cancer; · Provide additional product release specifications for our encapsulated cells; · Demonstrate comparability between the 1st and 2nd generation of our product candidate for pancreatic cancer and ensure adequate and consistent product performance and safety between the two generations; · Conduct a biocompatibility assessment using the capsules material; · Address specified insufficiencies in the Chemistry, Manufacturing and Controls information in the cross-referenced Drug Master File; · Conduct an additional nonclinical study in animals to assess the safety, activity, and distribution of the product candidate for pancreatic cancer; and · Revise the Investigators Brochure to include any additional preclinical studies conducted in response to the clinical hold and remove any statements not supported by the data we generated. The FDA also requested that we address the following issues as an amendment to our IND: · Provide a Certificate of Analysis for pc3/2B1 plasmid that includes tests for assessing purity, safety, and potency; · Perform qualification studies for the drug substance filling step to ensure that the product candidate for pancreatic cancer remains sterile and stable during the filling process; · Submit an updated batch analysis for the product candidate for the specific lot that will be used for manufacturing all future product candidates; · Provide additional details for the methodology for the Resorufin (CYP2B1) potency and the PrestoBlue cell metabolic assays; · Provide a few examples of common microcatheters that fit the specifications in our Angiography Procedure Manual; · Clarify the language in our Pharmacy Manual regarding proper use of the syringe fill with the product candidate for pancreatic cancer; and · Provide a discussion with data for trial of the potential for cellular and humoral immune reactivity against the heterologous rat CYP2B1 protein and potential for induction of autoimmune-mediated toxicities in our study population. We assem