PharmaCyte Biotech Provides Update to Nasdaq Listing Efforts and Presents Scientific Publications Supporting Pancreatic Cancer Treatment

PharmaCyte’s Chief Executive Officer (CEO), Kenneth L. Waggoner, commenting on the Company’s expected uplist to Nasdaq said, “As we head into the ninth day of a required 10 days of trading following a reverse stock split, we remain above the price requirement necessary to complete our list of criteria for the expected uplist. Our hope is that PharmaCyte will be trading on the highly respected platform and will become a Nasdaq listed company as early as next week.”

Waggoner continued, “With a number of recent well-respected scientific review publications supporting the approach that our technology uses as a promising treatment for pancreatic cancer, it is a validation, of sorts, of our approach and technology against the disease by independent scientists.”

Three recently published high profile international medical and scientific review articles have highlighted PharmaCyte’s pancreatic cancer treatment. The articles mention (i) the treatment’s use in clinical trials to develop a cellular microencapsulation technology to treat pancreatic cancer; (ii) the use of prodrugs in its treatment; and (iii) the treatment’s role in improving the pancreatic cancer treatment landscape.

First, the respected scientific journal, Drug Discovery Today, published an article by a Spanish academic group, known for their expertise in the field of cellular encapsulation titled, “Cell microencapsulation technologies for sustained drug delivery: Clinical trials and companies.” This publication stresses that the Cell-in-a-Box^® technology has been tested for years at the preclinical level as well as in two previously successful human clinical trials.

The authors summarize the results of the trials, essentially stating that microencapsulated cells that overexpressed cytochrome P450 2B1 (CYP2B1), which metabolizes the chemotherapy prodrug ifosfamide, transformed it into its active metabolites. These microencapsulated cells were implanted in 27 patients with pancreatic cancer. By placing the microencapsulated cells close to the area to be treated, a more focused therapy is obtained and, thus, better results are expected with lower doses of the chemotherapy prodrug ifosfamide.

In the first Phase 1/2 clinical trial using a 1 g/m²/per day dose of ifosfamide, the median survival of patients was doubled and only one of the patients had treatment-related adverse effects. In a second Phase 2 clinical trial, the prodrug ifosfamide per day dose was increased to 2 g/m²/day. The results showed greater severe adverse effects, but the efficacy profile was similar to the results from the Phase 1/2 clinical trial. The publication notes that PharmaCyte is “continuing with these promising clinical trials and are currently conducting the tests required by the regulatory agencies to begin a Phase 2b clinical trial as soon as possible.” (Lopez-Mendez et al., 2021, Drug Discovery Today 26, 852-861)

The sentiment expressed by Lopez-Mendez et al. is echoed in another recent review from the World Journal of Gastroenterology, “Room for improvement in the treatment of pancreatic cancer: Novel opportunities from gene targeted therapy,” from the Department of Gastroenterology, Addenbrooke’s Hospital, Cambridge, U.K. This particular review specifically states, “The cytochrome P450/ifosfamide system proof of concept from pre-clinical studies has been used to conduct Phase 1 and Phase 2 clinical trials in pancreatic cancer patients with phenomenal success (improvement of 1-year survival by 3-fold and median survival doubled).” (Galanopoulos et al., 2021, World J Gastroenterol 27, 3568-3580)

The third publication supports the activity of PharmaCyte’s pancreatic cancer treatment titled, “Prodrugs and prodrug-activated systems in gene therapy.” This publication that appeared in the high impact journal Molecular Therapy states, “At a dose of 1 g/m², ifosfamide was well tolerated by all patients in the first part of the trial, with regression of tumors in four patients and stable disease in the other participants.” (Sheikh et al., 2021, Molecular Therapy 29, 1716-1728)

PharmaCyte’s CEO added, “The positive assessments of our technology and its use in the treatment of pancreatic cancer by the authors of these key publications, underscore how important it is for us to receive the U.S. Food and Drug Administration’s approval to start our clinical trial in locally advanced and inoperable pancreatic cancer.”

To learn more about PharmaCyte’s pancreatic cancer treatment and how it works inside the body to treat locally advanced inoperable pancreatic cancer, we encourage you to watch the company’s documentary video complete with medical animations at: https://www.PharmaCyte.com/Cancer.

About PharmaCyte Biotech

PharmaCyte Biotech, Inc. is a biotechnology company developing cellular therapies for cancer and diabetes based upon a proprietary cellulose-based live cell encapsulation technology known as “Cell-in-a-Box^®.” This technology is being used as a platform upon which therapies for several types of cancer and diabetes are being developed.

PharmaCyte’s therapy for cancer involves encapsulating genetically engineered human cells that convert an inactive chemotherapy drug into its active or “cancer-killing” form. For pancreatic cancer, these encapsulated cells are implanted in the blood supply to the patient’s tumor as close as possible to the site of the tumor. Once implanted, the chemotherapy prodrug ifosfamide that is normally activated in the liver is given intravenously at one-third the normal dose. The ifosfamide is carried by the circulatory system to where the encapsulated cells have been implanted. When the ifosfamide flows through pores in the capsules, the live cells inside act as a “bio-artificial liver” and activate the chemotherapy prodrug ifosfamide at the site of the cancer. This “targeted chemotherapy” has proven effective and safe to use in past clinical trials and we believe results in little to no treatment related side effects.

PharmaCyte’s therapy for Type 1 diabetes and insulin-dependent Type 2 diabetes involves encapsulating a human liver cell line that has been genetically engineered to produce and release insulin in response to the levels of blood sugar in the human body. PharmaCyte is also considering the use of genetically modified stem cells to treat diabetes. The encapsulation of the cell lines will be done using the Cell-in-a-Box^® technology. Once the encapsulated cells are implanted in a diabetic patient, we anticipate that they will function as a “bio-artificial pancreas” for purposes of insulin production.

Safe Harbor

This press release may contain forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995 that express the current beliefs and expectations of the management of PharmaCyte. Any statements contained in this press release that do not describe historical facts are forward-looking statements that are subject to risks and uncertainties that could cause actual results, performance and achievements to differ materially from those discussed in such forward-looking statements. Factors that could affect our actual results include our ability to up-list our common stock to a national securities exchange and then maintain such listing, raise the necessary capital to fund our operations and to find partners to supplement our capabilities and resources, satisfactorily address the issues raised by the U.S. Food and Drug Administration in order to have the clinical hold removed on our Investigational New Drug Application so that we may proceed with our planned clinical trial for locally advanced and inoperable pancreatic cancer, as well as such other factors that are included in our periodic reports on Form 10-K and Form 10-Q that we file with the U.S. Securities and Exchange Commission. These forward-looking statements are made only as of the date hereof, and we undertake no obligation to update or revise the forward-looking statements, except as otherwise required by law, whether as a result of new information, future events or otherwise.

More information about PharmaCyte Biotech can be found at www.PharmaCyte.com. Information may also be obtained by contacting PharmaCyte’s Investor Relations Department.

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