PharmaCyte Biotech Reports Third Quarter Financial Results and Operational Highlights
March 16 2022 - 9:00AM
Business Wire
PharmaCyte Biotech, Inc. (NASDAQ: PMCB), a biotechnology company
focused on developing cellular therapies for cancer and diabetes
using its signature live-cell encapsulation technology,
Cell-in-a-Box®, announced today the financial and operational
results for its third quarter ended January 31, 2022, and provided
an overview of recent operational highlights (PharmaCyte’s Fiscal
Year begins May 1 and ends April 30).
Cash Position: PharmaCyte had approximately $87 million
in cash on hand as of January 31, 2022.
Recent Q3 Highlights—Corporate:
- PharmaCyte established FDIC insured accounts of approximately
$50.3 million.
Recent Highlights—Pipeline Products:
- In November 2021, PharmaCyte announced that the empty capsule
material that makes up its CypCaps™ pancreatic cancer product does
not cause skin irritation.
- In November 2021, PharmaCyte launched its malignant ascites
program with the commencement of a pivotal study to determine if
its treatment for locally advanced, inoperable pancreatic cancer
(LAPC)—Cell-in-a-Box (CypCaps) combined with the cancer killing
prodrug ifosfamide—can also delay the production and accumulation
of malignant ascites.
- In December 2021, the Company successfully completed the
Cytochrome P450 site of integration DNA sequencing assay and
announced the results of an additional, more detailed, analysis of
the integration site of the cytochrome P450 2B1 gene from the
augmented HEK293 cell clone that PharmaCyte uses in its CypCaps
product.
- In December 2021, PharmaCyte successfully completed the
36-month time point in its ongoing Master Cell Bank stability
study.
- In January 2022, PharmaCyte announced that the empty capsule
material that makes up PharmaCyte’s CypCaps pancreatic cancer
product candidate is not toxic for the encapsulated cells inside
the CypCaps.
- In February 2022, PharmaCyte provided a comprehensive update of
the status of its Investigational New Drug Application (IND) to the
U.S. Food and Drug Administration (FDA). Among other things,
PharmaCyte reported on: (i) the ongoing stability studies of its
clinical trial product CypCaps; (ii) the additional studies it has
commenced in response to the FDA’s requests related to the clinical
hold; (iii) the exact sequence of the Cytochrome P450 2B1 gene in
its clinical trial product; (iv) the biocompatibility studies it
has completed and that are underway; (v) micro-compression and
swelling assays being conducted on its clinical trial product; (vi)
break force and glide testing on its clinical trial product; (vii)
studies to show that its clinical trial product is not adversely
affected by the catheters interventional radiologists use to
deliver the CypCaps to a patient; and (vii) tests to show that its
clinical trial product is not affected by the contrast medium used
by interventional radiologists to help guide the implantation of
the CypCaps into a patient.
Recent Highlights—Financial:
As of January 31, 2022, PharmaCyte’s cash balance and total
assets were approximately $87 million.
On January 31, 2022, PharmaCyte’s total stockholder equity was
approximately $91 million.
PharmaCyte’s “Other Expenses” decreased by approximately $45,000
and $68,000 for the three and nine months ended January 31,
2022.
Operating expenses increased for the three months ended January
31, 2022, by approximately $99,000 and $297,000 for the nine months
ended January 31, 2022, as compared to the prior fiscal year, due
to costs associated with: (i) research and development (R&D);
(ii) an uplist to Nasdaq Capital Markets; (iii) the closing of two
public offerings for approximately $90 million; and (iv) and
conducting studies related to lifting the FDA’s clinical hold on
PharmaCyte’s proposed treatment for LAPC.
PharmaCyte’s R&D expenses increased from the start of its
fiscal year to about $526,000 to date. The two capital raises
PharmaCyte conducted in August 2021 allowed for these necessary
expenses to be possible.
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, a chemotherapy drug that is
normally activated in the liver (ifosfamide) 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 function as a “bio-artificial liver” and
activate the chemotherapy drug 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 cell line that has
been genetically engineered to produce and release insulin in
response to the levels of blood sugar in the human body. The
encapsulation of the cell line 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 herein 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 raise the
necessary capital to fund our operations and to find partners to
supplement our capabilities and resources, our ability to
satisfactorily address the issues raised by the FDA in order to
have the clinical hold on our IND removed, as well as such other
factors that are included in the 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.
View source
version on businesswire.com: https://www.businesswire.com/news/home/20220316005395/en/
Investor Relations: Dr. Gerald W. Crabtree PharmaCyte
Biotech, Inc. Telephone: 917.595.2856 Email:
InvestorRelations@PharmaCyte.com
PharmaCyte Biotech (NASDAQ:PMCB)
Historical Stock Chart
From Mar 2024 to Apr 2024
PharmaCyte Biotech (NASDAQ:PMCB)
Historical Stock Chart
From Apr 2023 to Apr 2024