PharmaCyte Biotech Announces Preliminary Unaudited Financial Results for Fiscal Year 2022
July 11 2022 - 8:30AM
Business Wire
PharmaCyte Biotech, Inc. (NASDAQ: PMCB), a biotechnology company
focused on developing cellular therapies for cancer, diabetes and
malignant ascites using its signature live-cell encapsulation
technology, Cell-in-a-Box®, today announced its preliminary
unaudited financial results for fiscal year ended April 30,
2022.
Cash Position
PharmaCyte had $85.4 million in cash and cash equivalents as of
April 30, 2022.
Preliminary (Unaudited) 2022 Fiscal Year End Financial
Results
PharmaCyte expects to report operating expenses of approximately
$4.4 million, compared to $3.6 million in the prior fiscal year.
This increase is primarily due to expenses associated with
PharmaCyte listing on Nasdaq and two capital raises totaling
approximately $90 million.
Net loss for fiscal year 2022 is expected to be approximately
$4.2 million or approximately $0.27 per share, compared with a net
loss of $3.6 million, or $2.45 per share, for the prior fiscal
year.
Management Commentary
PharmaCyte’s Chief Executive Officer, Kenneth L. Waggoner,
commented, “During fiscal year 2022, our team focused on fulfilling
the long list of requests from the FDA in order to have the
clinical hold lifted on our planned phase 2b clinical trial in
locally advanced, inoperable pancreatic cancer (LAPC). To date, we
have completed almost two dozen studies with only a few remaining.
Shortly, we expect to begin our two-phase pig study. This is the
last major study required by the FDA.
“Our team has made considerable progress during the year, while
controlling costs despite the worldwide supply chain challenges.
Our progress through a challenging year demonstrates the value of
our experienced and proven team of scientific and medical
professionals who have played key roles in helping to get some of
the world’s most successful drugs through the clinic.
“We believe the market opportunity to develop cellular therapies
for cancer, diabetes and malignant ascites using our signature
live-cell encapsulation technology, Cell-in-a-Box®, is significant.
With our enhanced cash position and recent uplisting to Nasdaq, we
are positioned to methodically scale the business and further
enhance our already strong scientific team as well as adding
complementary capital markets experience to our Board of Directors.
We are in the process of thoroughly vetting candidates to ensure
that the best people are in place to help us seize the
opportunities presented by the strength of our technology,
therapies, and cash position.
“We are motivated not just by the market opportunity for our
Company, but by the groundbreaking implications for patients. We
are frustrated by the value of our stock, which like many biotech
companies today, is trading below cash value. That said, we remain
intent on continuing to drive our clinical progress toward a
solution that we believe can revolutionize our treatment for
cancer, diabetes, and malignant ascites and, in turn, create
long-term shareholder value.”
Recent Highlights
- On July 5, 2022, the Company announced it has fulfilled another
item from the list of required FDA tasks for its pancreatic cancer
product candidate. This was done through the completion of a study
that confirmed the qRT-PCR can be successfully implemented for
testing. It also confirmed the identity and stability of the
cytochrome P450 expression construct in the cells used for the
production of CypCaps™ both before and after encapsulation in the
cGMP batches.
- On June 2, 2022, PharmaCyte’s Board of Directors authorized a
share repurchase program to repurchase up to $10 million of
PharmaCyte’s outstanding shares of common stock. The share
repurchase will begin shortly after issuance of our preliminary
year-end financial results in this press release.
- On May 23, 2022, PharmaCyte announced that it has initiated the
first in a new series of studies to test the ability of its
pancreatic cancer therapy to treat malignant ascites. This is the
eighth and final preclinical study that may lead to a Phase 1
clinical trial. Such a clinical trial may allow us to validate the
technology much faster than PharmaCyte’s planned Phase 2b clinical
trial in LAPC.
- On April 19, 2022, PharmaCyte reported positive results to
satisfy FDA requirements related to the empty capsule material that
comprises its pancreatic cancer clinical trial product
candidate.
- On April 13, 2022, the Company announced that it would
accelerate preparations for the start of its Phase 2b clinical
trial in LAPC by working parallel paths to have the clinical hold
lifted and enroll the first patient in the clinical trial for
LAPC.
- On April 5, 2022, PharmaCyte announced the appointment of Dr.
Matthias L�hr to its Board of Directors. Dr. L�hr is Professor of
Gastroenterology and Hepatology at the famed Karolinska Institute
in Stockholm, Sweden, and leads the Pancreatic Team at Karolinska
University Hospital. He has held dozens of leadership roles in
learned societies, cancer research centers, universities and
governmental agencies.
- On March 22, 2022, PharmaCyte announced it had successfully
completed a 24-month product stability study required by the FDA
for its pancreatic cancer clinical trial product candidate. This
demonstrates that CypCaps has now proven it has a shelf life of at
least 24 months when stored at -80 degrees Celsius.
Cautionary Statement
The financial data contained in this press release are
preliminary and unaudited, based upon PharmaCyte’s good faith
estimates and subject to completion of PharmaCyte's financial
closing procedures. While PharmaCyte expects that its final
financial results for its fiscal year and quarter ended April 30,
2022, following the completion of its financial closing procedures,
will generally be consistent with the amounts provided in this
press release. PharmaCyte's actual results may differ materially
from these estimates as a result of the completion of its financial
closing procedures, as well as final adjustments and other
developments that may arise between now and the time that its
financial results for the fiscal year and quarter ended April 30,
2022, are finalized.
The results provided in this press release are preliminary and
subject to completion and audit of PharmaCyte’s financial
statements.
About PharmaCyte Biotech
PharmaCyte Biotech, Inc. is a biotechnology company developing
cellular therapies for cancer, diabetes and malignant ascites 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,
diabetes and malignant ascites 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 candidate 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.
PharmaCyte’s therapy for malignant ascites involves using the
same encapsulated cells PharmaCyte employs for pancreatic cancer
but placing the encapsulated cells in the peritoneal cavity of a
patient and administering ifosfamide intravenously.
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 PharmaCyte’s
management and Board of Directors. Any statements contained in this
press release which do not describe historical facts are
forward-looking statements subject to risks and uncertainties that
could cause actual results, performance and achievements to differ
materially from those discussed in such forward-looking statements,
including material differences between the Company’s actual
financial results and the preliminary financial results presented
herein. Factors that could affect our actual results include 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
https://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/20220711005262/en/
Investor Relations: PharmaCyte Biotech, Inc. Telephone:
917.595.2856 Email: InvestorRelations@PharmaCyte.com Attn: Dr.
Gerald W. Crabtree
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