WPD Pharmaceuticals Inc. (CSE: WBIO)(FSE: 8SV1)
(the
“Company” or
“WPD”), a
clinical stage pharmaceutical company, is pleased to provide a
corporate update on its business and the continued development of
its portfolio of drug candidates.
“It’s been some time since our last corporate
update after going public in January. Given these difficult
times during social distancing and isolation, we feel it’s
important to continue communicating to our shareholders and provide
an update on the advancements of our drug portfolio,” commented
Mariusz Olejniczak, CEO of WPD. “We have made
great strides advancing our comprehensive drug portfolio with our
license partners, Moleculin Biotech and CNS Pharmaceuticals and we
are looking forward to executing on our growth strategy.”
Balance Sheet and Capital
Structure
In February 2020, the Company received $825,714
from the exercise of warrants and options previously issued. WPD's
current cash and cash equivalents are about CAD $2 million, with no
long-term debt. The Company has 112,991,816 million common shares
issued and outstanding with the majority held under a 36 month
escrow. Management and insiders own 35.5%.
WPD has sufficient liquidity and capital to fund
its operations into 2021, while continuing to advance its drug
portfolio with license partners CNS Pharmaceuticals Inc.
(“CNS”) and Moleculin Biotech, Inc.
(“Moleculin”). WPD received CAD $800,000 in
reimbursement from the Polish National Center for Research and
Development for the development of WPD101, exclusively licensed
from Wake Forest University. The total amount accessible under the
grant is approximately CAD $7.4 million. For the development of its
entire drug portfolio, WPD has access to CAD $20 million in
non-dilutive, government grant, payable on reaching certain
milestones.
Scientific Board
Appointments
WPD is pleased to welcome Waldemar Debinski, the
inventor of WPD’s drug candidates WPD101, WPD102 and WPD103, to its
Scientific Advisory Board. The Company’s name “WPD” comes from the
names of founder Waldemar Priebe and inventor, Waldemar Debinski.
Dr. Debinski joins WPD’s esteemed scientific team of experts
and his experience and knowledge of researching and developing drug
candidates will be extremely valuable as the Company continues to
advance its drug portfolio.
Dr. Waldemar Debinski
commented, “It is exciting to see that WPD Pharmaceuticals has
begun developing several promising platforms for cancer treatment
in areas of unmet needs in medicine. Targeted cytotoxic therapy,
rational chemotherapy and other types of treatments should bring
much desired hope, especially to patients with aggressive forms of
cancer. The dedicated and superbly trained WPD personnel will
assure both timely and efficient transfer of the lab ideas to the
clinic, of which I am pleased to be part.”
Dr. Waldemar Debinski, MD, PhD,
is the Tom and Laura Hearn Professor for the Brain Tumor Center of
Excellence and Director of the Brain Tumor Center of Excellence,
Wake Forest Baptist Medical Center Comprehensive Cancer Center, and
professor of cancer biology, radiation oncology, Microbiology and
immunology, and Translational Science Institute at Wake Forest
School of Medicine. He has pioneered the discovery and use of
targets in malignant brain tumor cells that are not present in
normal brain tissue to destroy them effectively and safely. With a
broad range of expertise and experience in both basic science and
preclinical models, he develops novel approaches to drug
development and delivery and partners with industry for both
therapeutic and licensing purposes. Debinski holds
twenty-five patents on various therapeutics and other
cancer-fighting solutions, including a drug candidate that uses
specific molecular targets to treat glioblastoma while also being
less toxic than radiation and chemotherapy and less invasive than
surgery.
With deep expertise in novel approaches to drug
development and delivery, Dr. Debinski partners with industry for
both licensing of new therapeutic approaches and their clinical
development. Because cancers of the brain resemble some other solid
tumors at a molecular level, he believes that his discoveries may
also be applicable to other aggressive types of cancers.
COVID-19
Through its license partner Moleculin, WPD is
now a part of a collaboration with a leading government funded
research facility in the United States to conduct research on its
patented portfolio of molecular inhibitors, including drug
candidate, WP1122, for antiviral properties against a range of
viruses, including COVID-19. Testing will begin on the WP1122 drug
for antiviral properties against viruses, including the prevalent
Coronavirus. The in vivo research supporting the use of 2-DG as a
dual inhibitor of glycolysis and glycosylation shows promise to
defeat viruses like Coronavirus through multiple effects critical
to the progression of viral infection.
WPD also announced that it has partnered with
license partner, CNS on the development of several preclinical drug
candidates including WP1122, which will be tested on a range of
viruses including the coronavirus SARS-CoV-2. WPD will receive a
portion of the development costs from CNS for WP1122 and other drug
candidates for antiviral indications, and CNS will receive certain
economic rights. WPD received an upfront cash payment of $225,000
and CNS has committed to a milestone payment of $775,000 upon the
successful completion of a Phase 2 study. In return for the
funding, CNS is entitled to receive 50% of the net sales of
resulting commercial products in WPD’s 31 licensed territories.
During this urgent global fight against
COVID-19, it is the responsibility of every biotech company to
remain committed to research and test its entire drug portfolio to
find alternative treatments for patients.
Drug Portfolio Review
To date, over CAD$100 million has gone towards
the development of the Company’s robust drug development pipeline
with an additional CAD$20 million in grants conditionally awarded
to the Company from the NCRD in Poland. WPD has made
significant developments to its drug portfolio. Highlights
include:
Berubicin
WPD is pleased to announce that a patient from
the Phase 1 clinical trial of its Berubicin drug for the treatment
of glioblastoma multiforme ("GBM") remains cancer
free. The clinical trial was conducted by $4Bn pharmaceutical
company, Reata Pharmaceuticals, Inc, which was founded by WPD
founder, Waldemar Priebe. GBM is an aggressive type of brain cancer
and currently, there are no effective therapies approved to treat
this disease.
Through CNS, it has also received positive
feedback from the U.S. Food and Drug Administration
(“FDA”) for its Pre-IND (Investigational New Drug)
meeting proposal to use Berubicin in Phase 2 clinical trials. In
collaboration with CNS, initiating the Phase 2 clinical trial in
the second half of this year. Concurrently, WPD and CNS will be
starting the upcoming Phase I clinical trial at Children’s Memorial
Health Institute, the largest pediatric hospital in Poland. The
Company believes this Phase I trial of Berubicin at Children’s
Memorial represents the first ever investigation of an
anthracycline and topoisomerase II inhibitor in pediatric brain
tumors.
Annamycin
WPD’s annamycin drug candidate received positive
interim results from phase 1/2 clinical studies in acute myeloid
leukemia (“AML”). WPD’s license partner Moleculin
disclosed additional positive interim safety and efficacy data from
one of the two ongoing open label, single arm Phase 1/2 studies of
Annamycin for the treatment of relapsed or refractory
AML.
WPD Drug Portfolio
In February 2020, WPD was granted a key patent
exclusively licensed from Wake Forest University and the patent
relates to the WP101, WPD102 and WPD103 drug candidates, used in
the therapy of GBM multiform and other tumors. WPD is
developing WPD101, which is currently in preclinical development
and its consistent anticancer properties are demonstrated and
validated in dogs with spontaneous GBM closely resembling GBM in
human patients. Overall, results of these studies indicate the
significant potential of WPD101 demonstrating the same effective
treatment of GBM in humans. Phase I clinical trials are expected to
begin in the next 12 months.
Acquisition of Drug Candidates – WP1122 and
WP1732
WPD completed the acquisition of exclusive
sublicenses for two pancreatic cancer drug candidates, WP1122 and
WP1732 from license partner Moleculin. The acquisitions bring the
total development funding spent on WPD’s portfolio of drugs under
license to over USD$100 million. The territory covered by the
patents includes 30 countries in Europe and Asia, including
Russia.
The licensed drug candidates, WP1122 and WP1732,
are both considered promising potential therapies for treating
pancreatic cancer, among other highly resistant tumors. Both
candidates were developed at a leading cancer center in the
U.S.
About WPD Pharmaceuticals
WPD is a biotechnology research and development
company with a focus on oncology, namely research and development
of medicinal products involving biological compounds and small
molecules. WPD has 8 novel drug candidates with 4 that are in
clinical development stage and 4 in pre-clinical development. These
drug candidates were researched at institutions including MD
Anderson Cancer Center, Mayo Clinic and Emory University, and WPD
currently has ongoing collaborations with Wake Forest University
and leading hospitals and academic centers in Poland.
WPD has entered into license agreements with
Wake Forest University Health Sciences and sublicense agreements
with Moleculin Biotech Inc. and CNS Pharmaceuticals, Inc.,
respectively, each of which grant WPD an exclusive, royalty-bearing
sublicense to certain technologies of the licensor. Such agreements
provide WPD with certain research, development, manufacturing and
sales rights, among other things.
On Behalf of the Board
‘Mariusz Olejniczak’
Mariusz OlejniczakCEO, WDP Pharmaceuticals
Cautionary Statements:
Neither the Canadian Securities Exchange nor the Investment
Industry Regulatory Organization of Canada accepts responsibility
for the adequacy or accuracy of this release.
This press release contains forward-looking
statements. Forward-looking statements are statements that
contemplate activities, events or developments that the Company
anticipates will or may occur in the future. These
forward-looking statements include that we will get access to
grants or other funding conditionally awarded to us or
contractually agreed and that our drugs may prove effective in
treatment of certain diseases. Factors which may prevent the
forward looking statement from being realized is that we don’t
reach milestones required and don’t receive any additional funds
from grants or other arrangements; that our research does not
result in any advance against viral diseases or cancer; that
competitors or others may successfully challenge a granted patent
and the patent could be rendered void; that we are unable to raise
sufficient funding for our research; that we may not meet the
requirements to receive the grants awarded; that our drugs don’t
provide positive treatment, or if they do, the side effects are
damaging; competitors may develop better or cheaper drugs; and we
may be unable to obtain regulatory approval for any drugs we
develop. Readers should refer to the risk disclosure included from
time-to-time in the documents the Company files on SEDAR, available
at www.sedar.com. Although the Company believes that the
assumptions inherent in these forward-looking statements are
reasonable, they are not guarantees of future performance and,
accordingly, they should not be relied upon and there can be no
assurance that any of them will prove to be accurate.
Finally, these forward-looking statements are made as of the date
of this press release and the Company assumes no obligation to
update them except as required by applicable law.
Contact:
Investor RelationsEmail: investors@wpdpharmaceuticals.comWeb:
www.wpdpharmaceuticals.com
WPD Pharmaceuticals (CSE:WBIO)
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