PharmaCyte Biotech Reports Second Quarter 2021 Financial Results and Operational Highlights
December 15 2021 - 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 results for its
second quarter ended October 31, 2021, 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 October 31, 2021.
Recent Q2 Highlights—Corporate:
- Common stock was listed on Nasdaq Capital Markets as the
Company began trading as a Nasdaq-listed company
- Closed on a $15-million public offering
- Closed on a $70-million registered direct offering
- Company had warrant conversions of approximately $10.7
million
- PharmaCyte expanded its Product Pipeline beyond its Cancer
Program to include a Diabetes Program and a Malignant Ascites
Program.
Recent Highlights—Pipeline Products:
- The Company’s capital raises allowed PharmaCyte to spend what
was needed in Research and Development (R&D) expenses to
perform the work required to have the FDA imposed clinical hold
lifted. PharmaCyte will issue a 2021 year-end update to detail
which tests/studies have been completed, which have commenced, and
which remain for PharmaCyte to present to the FDA with updated data
in its effort to lift the FDA’s clinical hold.
- In August 2021, PharmaCyte announced its clinical trial
product, CypCaps™ remains stable and active at 18 months after
completing the 18-month timepoint of ongoing product stability
testing required by the U.S. Food and Drug Administration
(FDA).
- In September 2021, the Company announced the first test results
of the biocompatibility studies of its CypCaps clinical trial
product candidate. These positive results were from an “In Vitro
Complement Activation Study of Empty Cellulose Sulphate Capsules,”
the same capsules PharmaCyte plans to use in its treatment to treat
locally advanced, inoperable pancreatic cancer (LAPC). The first
results showed that the capsule material does not activate a major
line of the human body’s innate defense – the complement
system.
- In September 2021, PharmaCyte announced the results of a second
FDA-required test of biocompatibility of its CypCaps product for
the treatment of LAPC. The results showed that the empty capsule
material is “non-hemolytic.” The data showed that the capsule
material does not cause blood cells to lyse either after direct or
indirect contact with blood. Moreover, it confirms prior data that
was observed previously in animal models and previous clinical
trials.
- In September 2021, PharmaCyte announced the results from a
third test of biocompatibility of its CypCaps product candidate for
pancreatic cancer. The results showed that the empty capsule
material is not “mutagenic.” A mutagen is a physical or chemical
agent that permanently changes genetic material, usually DNA, in an
organism and thus increases the frequency of mutations above the
natural background level.
- Since the close of PharmaCyte’s quarter ended October 31, 2021,
the PharmaCyte announced that: (i) the empty capsule material that
makes up its CypCaps pancreatic cancer product does not cause skin
irritation, (ii) the commencement of a pivotal study to determine
if PharmaCyte’s treatment for pancreatic cancer, which PharmaCyte
plans to use for the treatment of LAPC—CypCaps combined with the
cancer killing chemotherapy prodrug ifosfamide—can also delay the
rate of production and accumulation of malignant ascites. This is
fluid that accumulates in the abdominal cavity from various
cancers, and (iii) the results of an additional, more detailed,
analysis of the integration site of the cytochrome P450 2B1 gene
from the Company’s genetically modified cell clone that it uses in
PharmaCyte’s CypCaps product for the treatment of LAPC.
Recent Highlights—Financial:
During the three months ended October 31, 2021, PharmaCyte’s
cash balance and total assets increased by approximately $86
million.
On October 31, 2021, PharmaCyte’s total stockholder equity
increased by approximately $86 million from July 31, 2021.
Other PharmaCyte expenses decreased by approximately $25,000 and
$23,000 for the three and six months ended October 31, 2021.
Operating expenses increased for the three months ended October
31, 2021, by approximately $55,000 and $197,000 for the six months
ended October 31, 2021, due to costs associated with an uplist to
Nasdaq Capital Markets, the closing of two public offerings, and
putting those funds to use in the start of new tests and studies
related to lifting the FDA clinical hold on PharmaCyte’s proposed
treatment for LAPC.
PharmaCyte’s R&D expenses increased from the start of its
fiscal year to about $360,000 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 act 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.
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version on businesswire.com: https://www.businesswire.com/news/home/20211215005364/en/
Investor Relations: Dr. Gerald W. Crabtree PharmaCyte
Biotech, Inc. Telephone: 917.595.2856 Email:
InvestorRelations@PharmaCyte.com
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