PharmaCyte Biotech, Inc.

PharmaCyte Biotech, Inc. operates as 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, with the current generation of its product candidate referred to as CypCaps. The company is developing therapies for pancreatic tumors by using genetically engineered live human cells that may be capable of converting a cancer prodrug into its cancer-killing form, with the goal of meeting the medical need for patients with locally advanced, inoperable, non-metastatic pancreatic cancer (LAPC) whose tumors no longer respond after 4-6 months of treatment with the chemotherapy combination of Abraxane plus gemcitabine or the four-drug combination known as FOLFIRINOX. The American Cancer Society estimated that in 2025 there were 67,000 people in the U.S. diagnosed with pancreatic cancer and estimated 52,000 patients with pancreatic cancer died in 2025, with pancreatic cancer accounting for about 3% of all cancers in the U.S. and about 7% of all cancer deaths. The industry is characterized by intense competition, with dozens of startups, smaller biotech companies, big pharma, and several academic institutions and cancer centers all trying to improve outcomes for pancreatic cancer patients, and several drugs already available including the FDA-approved combination of Abraxane and gemcitabine and the four-drug combination FOLFIRINOX used as a first-line treatment for advanced pancreatic cancer in Europe and the U.S.

The company faces intense competition in the field of treating pancreatic cancer, with competitors including dozens of startups, smaller biotech companies, big pharma, and several academic institutions and cancer centers. Many competitors have substantially greater financial and marketing resources, stronger name recognition, better brand loyalty and long-standing relationships with customers and suppliers. Competitive strengths include the Orphan Drug Designation granted by the FDA and the European Medicines Agency for the pancreatic cancer therapy. The company believes its cellulose-based Cell-in-a-Box capsules provide advantages over competitors who use materials including alginate, collagen, chitosan, gelatin and agarose, with alginate appearing to be the most widely used, as the company believes the inherent strength and durability of its cellulose-based capsules provides advantages with no evidence of rupture, damage, degradation, fibrous overgrowth or immune system response, while other encapsulating materials degrade in the human body over time.

The company generates revenue through the development of cellular therapies for cancer using its live cell encapsulation technology, with the business model centered on developing and preparing to commercialize therapies for several types of cancer including LAPC. The company has an exclusive, worldwide license to use, with a right to sublicense, the Cell-in-a-Box technology and trademark for the development of therapies for cancer, and the technology is intended to be used as a platform upon which therapies for several types of cancer will be developed. The company's revenue model includes future royalty payments of four percent royalty on all gross sales received by the company or its affiliates, twenty percent royalty on gross revenues received by the company or its affiliates from a sublicense or right to use the patents or the licenses, and fifty percent of any other financial and non-financial consideration received from sublicensees of the Cell-in-a-Box technology.

The company's product candidate CypCaps is based on the Cell-in-a-Box encapsulation technology, which is designed to present genetically engineered live human cells to targeted tissues, resulting in pinhead-sized cellulose-based porous capsules in which genetically modified live human cells can be encapsulated, grown to confluence and maintained in a cryopreserved state until shortly before they are injected into an appropriate patient. The company has been developing therapies for pancreatic tumors by using genetically engineered live human cells that may be capable of converting a cancer prodrug into its cancer-killing form, encapsulating those cells using the Cell-in-a-Box technology and placing those capsules in the body as close as possible to the tumor. The company believes 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 of the patient's cancerous tumor may be optimized both by enhanced potency and limited exposure away from the target tumor, and 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, which improves the probability of successful surgical resection of LAPC.

The company's development programs are currently under review by the Strategic Scientific Committee formed by the Board on November 17, 2023, chaired by Dr. Michael Abecassis, and the Board has reduced spending on programs including pre-clinical and clinical activities until the review 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 the company's relationship with SG Austria Pte. Ltd., and the company is reevaluating those programs which are dependent on SG Austria and the FDA's acceptance of its technologies, including development programs for LAPC. The company has been in ongoing dialogue with SG Austria to prepare for next steps including encapsulation of the cells, testing the glide force and pressure testing of pushing the cells through syringes and catheters. The company has successfully completed various studies requested by the FDA to address the clinical hold placed on October 1, 2020, including stability studies on the clinical trial product candidate for pancreatic cancer at timepoints of 3, 6, 9, 12, 18 and 24 months ¹ of being stored frozen at -80C, a stability study on the cells from the Master Cell Bank, determination of the exact sequence of the cytochrome P450 2B1 gene using nanopore sequencing, confirmation of the exact sequence of the cytochrome P450 2B1 gene insert, and eight of ten ² biocompatibility studies requested by the FDA have been completed successfully. The company had Austrianova Singapore Pte. Ltd. manufacture an additional 400 ³ syringes of empty capsules to enable the biocompatibility studies to be performed.

For the fiscal year ended April 30, 2026, the company reported total revenues of $0 ⁴ and net loss of $2,676,000 ⁵, compared to total revenues of $0 ⁶ and net loss of $5,088,000 ⁷ for the fiscal year ended April 30, 2025. The company had cash and cash equivalents of $15,172,163 ⁸ as of April 30, 2026, compared to $18,603,899 ⁹ as of April 30, 2025. The company's accumulated deficit was $151,721,633 ¹⁰ as of April 30, 2026, compared to $149,045,633 ¹¹ as of April 30, 2025.

The company has not provided specific quantitative revenue, margin, or EPS guidance for the upcoming period in the filing.

The company is pursuing growth through the development of its CypCaps product candidate for LAPC, with the goal of having the FDA lift the clinical hold on the IND submitted on September 1, 2020, so that a planned clinical trial in LAPC can commence. The company has assembled a scientific and regulatory team to address the FDA requests and has been in active dialog with the FDA during the year ended April 30, 2026, and is waiting for the FDA's responses and hopes the FDA will accept that the LAPC treatment now meets manufacturing standard requirements which have significantly improved since the clinical hold was first placed. The company is also identifying alternative approaches to expand the prodrug/activator technology for cancer treatment, which may expand prodrug/activation options to use highly toxic cancer-killing drugs in tightly controlled perivascular spaces.

The company is pursuing growth through the potential expansion of its Cell-in-a-Box technology platform for treating cancerous diseases by placing encapsulated drug-converting cells that convert a chemotherapy prodrug near the cancerous tumor, with the belief that increased efficacy of a chemotherapy prodrug may allow for lower doses of the prodrug to be given to a patient, significantly reducing or even eliminating side effects from the chemotherapy. The company believes there will be no therapy comparable to its Cell-in-a-Box plus low dose of ifosfamide combination therapy when used in LAPC patients whose tumors no longer respond after 4-6 months of treatment with the chemotherapy combination of Abraxane plus gemcitabine or FOLFIRINOX, for whom there are currently only limited therapy options.

The company's spending on development programs has been curtailed until the Scientific Committee completes its evaluation of the programs and the company enters into a new framework for its relationship with SG Austria. The Board has reduced spending on 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 company's operational outlook is focused on completing the remaining items requested by the FDA to lift the clinical hold, including micro-compression and swelling testing which is underway, developing a protocol to measure break force and glide testing, showing that CypCaps are not adversely affected by catheters used by interventional radiologists, and testing to show that exposure of CypCaps to contrast medium has no adverse effect. The company is also in ongoing dialogue with SG Austria to prepare for next steps including encapsulation of the cells, testing the glide force and pressure testing of pushing the cells through syringes and catheters. As of April 30, 2026, the company had two ¹² full-time employees and several consultants who devote substantial time to the company.

The company's capital allocation strategy is focused on funding the remaining activities to address the FDA clinical hold and the evaluation of programs by the Scientific Committee. The company has not disclosed specific R&D spending levels, capital expenditure plans, share repurchase authorization amounts, or dividend policy with exact figures in the filing.

The company faces structural headwinds including that all licensed patents have expired and that know-how relating to the Cell-in-a-Box technology solely resides with SG Austria, which the Board is reviewing as part of its risk assessment. The company also faces the risk that Austrianova, the sole source of the company's product candidates, may be experiencing liquidity issues and has from time to time experienced significant supply chain delays, and if Austrianova is unwilling or unable to perform manufacturing for the company, the company may not be able to locate a replacement manufacturer for its product candidates.

The company faces regulatory constraints including the clinical hold placed by the FDA on October 1, 2020, which requires the company to complete multiple studies and provide additional data before the hold can be lifted. The FDA may require additional preclinical studies when the meeting takes place, and the company's 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 company faces material risks including that all licensed patents for its Cell-in-a-Box technology have expired and that the know-how relating to the technology solely resides with SG Austria, creating dependency on a single third party for the core technology. The company's IND for a planned clinical trial in LAPC was placed on clinical hold by the FDA on October 1, 2020, and the company must complete multiple studies and provide additional data to have the hold lifted, with no guarantee the FDA will accept the data or that additional preclinical studies will not be required. Austrianova is the sole source of the company's product candidates and has from time to time experienced significant supply chain delays and may be experiencing liquidity issues, and if Austrianova is unwilling or unable to perform manufacturing, the company may not be able to locate a replacement manufacturer. The company had an accumulated deficit of $151,721,633 ¹³ as of April 30, 2026, and has generated no revenue from operations, with total revenues of $0 ¹⁴ for both fiscal 2026 and fiscal 2025, indicating a going concern risk. The company faces intense competition from dozens of startups, smaller biotech companies, big pharma, and academic institutions, many of which have substantially greater financial and marketing resources.

Management's message to shareholders emphasizes the company's focus on developing cellular therapies for cancer using the Cell-in-a-Box technology, with the current product candidate CypCaps being developed for LAPC. The Board formed the Strategic Scientific Committee on November 17, 2023, chaired by Dr. Michael Abecassis, to review risks relative to the business, and the Board is reviewing risks associated with development programs and the relationship with SG Austria, including that all licensed patents have expired and that know-how relating to the Cell-in-a-Box technology solely resides with SG Austria. Management has reduced spending on programs including pre-clinical and clinical activities until the review by the Scientific Committee and the Board is complete, and the Scientific Committee's recommendations will include potentially seeking a new framework for the relationship with SG Austria and its subsidiaries. Management is reevaluating programs dependent on SG Austria and the FDA's acceptance of its technologies, including development programs for LAPC, and is identifying alternative approaches to expand the prodrug/activator technology for cancer treatment.