Ansell Capital Corp. Announces Proposed Reverse Takeover
Transaction With BriaCell Therapeutics Corp.
VANCOUVER, BRITISH COLUMBIA--(Marketwired - Apr 17, 2014) -
Ansell Capital Corp. ("Ansell") (TSX-VENTURE:ACP) is extremely
pleased to announce that it has entered into a binding letter of
intent for the arm's length acquisition of 100% of the issued and
outstanding common shares of BriaCell Therapeutics Corp.
("BriaCell"), a private cancer immunotherapy company incorporated
under the laws of the State of Delaware (the "Proposed
Transaction") with its head office in Los Angeles, California. It
is expected that the combined entity, after completion of the
Proposed Transaction (the "Resulting Issuer"), will qualify as a
Tier 2 Issuer pursuant to the requirements of the TSX Venture
Exchange (the "Exchange").
The Proposed Transaction will be an arm's length transaction as
the directors and officers of Ansell presently have no interest in
BriaCell. It is intended that the Proposed Transaction shall take
place by way of an amalgamation, arrangement, share exchange or
other similar form of transaction. Once the structure is
determined, the letter of intent will be superseded by a definitive
agreement between Ansell and BriaCell, and the parties will
announce the signing of such definitive agreement and its general
terms by news release. As part of and prior to closing the Proposed
Transaction, Ansell anticipates a consolidation of its issued and
outstanding securities on a 3.25-old-for-one-new basis. The
Proposed Transaction will be considered a Change of Business and
Reverse Takeover for Ansell, as such term is defined in Exchange
Policy 5.2.
NAME CHANGE
It is intended that the Resulting Issuer will be named "BriaCell
Therapeutics Corp." or such other name as the parties may
reasonably agree upon, and the Resulting Issuer will be governed by
the British Colombia Business Corporations Act.
BUSINESS OF
BRIACELL
Summary
BriaCell is a Los Angeles based biotechnology company, with a
strong focus on cancer immunotherapy. BriaCell is developing and
advancing its patented SV-BR-1-GM Immunotherapy Vaccine for
patients with advanced breast cancer. BriaCell has already
successfully implemented two U.S. Food and Drug Administration
("FDA") Phase-I studies, wherein the Vaccine has proved safe and
has demonstrated significant promise in patients with advanced
breast cancer.
In the latest FDA Phase I human study, the vaccine showed
unprecedented results in a patient with advanced breast cancer
whose tumor was resistant to other types of cancer treatment. In
that particular patient, the observed regressions of the cancer
occurred in local-regional and distant metastatic sites, including
the brain.
BriaCell is uniquely positioned to rapidly advance its cancer
immunotherapy technology in an FDA approved Phase-I/II expanded
clinical trial with up to 24 breast cancer patients with advanced
stages of solid tumors. Additionally, the FDA-approved protocol has
provision to allow testing the vaccine in selected patients with
other cancers as well, including prostate, ovarian, pancreas, lung
and bladder cancers among others; and BriaCell is excited to
potentially apply its vaccine technology in managing such other
solid tumours in future trials.
Early Clinical Proof of
Concept
Studies of the SV-BR-1-GM vaccine have been conducted in humans
under an FDA Phase I protocol. To date, the vaccine has
demonstrated significant promise with little toxicity in two
separate FDA Phase-I clinical studies. FDA permission has been
granted for an expanded Phase I/II clinical trial to be conducted
on late staged breast cancer patients, with the ability to include
select cases of other tumours such as lung, bladder and
prostate.
The causal efficacy of the SV-BR-1-GM vaccine is supported by
the rapid induction of remission and re-induction of remission,
including brain metastases, in one the four patients treated with
the vaccine in the last Phase I clinical trial.
The observed regressions are considered unprecedented and were
seen in advanced cancer that was resistant to other types of cancer
treatment. The overall median survival time for the small SV-BR-1
GM vaccine group was 35 months, which is 5 times longer than
expected from published reports.
Market
Overview
In the U.S. alone, there are about approximately 3 million women
who have breast cancer. One out of eight American women is expected
to develop breast cancer during her lifetime, and for the year
2013, there were an estimated 39,626 deaths due to the disease.
Approximately 232,340 new cases of breast cancer were diagnosed in
the U.S. in 2013.
Immunotherapeutical technologies are coming to the forefront of
cutting edge cancer management approaches. Unlike current therapies
such as chemotherapy, vaccines are expected to be much less toxic,
more selective to specific cancers, and more likely to prevent the
recurrence of the disease.
According to the American Cancer Society, worldwide about 1.3
million women will be diagnosed with breast cancer annually and
about 465,000 will die from the disease each year. Metastatic
cancer, or cancer spread beyond the breast, generally results in
death within three years and complete remission of metastatic
cancer currently occurs in only approximately 10% of cases. Even
with successful chemotherapy inducing complete remission of
metastatic cancer, only 3.1% of breast cancer patients will still
be alive in five years.
Initial target population for the vaccine would be patients who
are at a terminal or pre-terminal stage. Using this very restricted
criteria, the annual death rates for certain HER-2 positive cancers
can be considered a conservative estimate for the number of
eligible patients. While breast cancer patients are eligible for
the Vaccine if negative or positive to HER-2 (BriaCell's case
report showed the unprecedented responses in a HER-2 negative
patient), to be eligible for the current FDA approved protocol,
non-breast cancer patients must test positive for the HER-2/neu
antigen. This antigen is estimated to be present in patients in 15%
to 30% of lung, gastric, ovary, bladder, pancreas and prostate
cancers.
Experienced
Leadership
BriaCell's experiences team is led a highly accomplished and
seasoned clinician scientist, Dr. Charles L. Wiseman (biography
below). Dr. Wiseman is a leader in the field of cancer management,
and pioneered chemotherapy treatments for breast cancer that are
considered the standard care of today.
Innovative
Therapy
BriaCell's technology is based on a whole-cell vaccination
approach known as SV-BR-1-GM. It was created by genetically
engineering a cancer cell line derived from one of Dr. Wiseman's
breast cancer patients, to synthesize the naturally occurring
cytokine GM-CSF. This cytokine is a powerful stimulant that is
being used to initiate an anticancer immune response in the
body.
Ability to Launch into
Expanded FDA Phase-I/II
FDA permission has been granted for an expanded Phase I/II
clinical trial to be conducted on selected cases of breast, lung,
bladder, prostate and other solid tumors, pending a resubmission of
the revised protocol. The vaccine research program is described in
a detailed protocol, submitted and approved by the FDA for imminent
clinical application. The protocol for the expanded clinical trial
has passed the review of the Western Institutional Review Board. A
new and effective treatment for breast cancer and certain other
HER-2 positive cancers can be a compelling reason for the FDA to
grant "fast track" approval. BriaCell is hopeful that the vaccine
will potentially be a candidate for fast track approval. While drug
development often takes 5 years or more, a much more rapid timeline
to FDA approval may be possible provided certain criteria are met.
Additionally, a new FDA category called "break-through therapy" has
recent been established. Under this program, the FDA actively
engages with qualifying companies to expedite meeting regulatory
milestones to expedite faster approvals. Without question, this
program would be sought out by BriaCell. However, there is no way
to predict how the FDA will evaluate BriaCell's submission.
Financial
Information
It is estimated that a similar company to BriaCell could
reasonably be expected to incur costs totaling approximately $7 -
10 million in order to get through a single FDA approved Phase I
clinical trial. BriaCell has successfully completed two such FDA
approved Phase-I trials with a fraction of that cost, approximately
$1.5 million, utilizing operational efficiency, its network of key
contacts, while taking advantage of hospital assistance and grants.
BriaCell intends to implement that same level of capital discipline
in taking BriaCell to the next level. Currently, BriaCell's
financials are not audited.
PROPOSED
MANAGEMENT OF THE RESULTING ISSUER
The current officers and directors of Ansell, except for Mr.
Rahoul Sharan, are expected to resign as of the closing of the
Proposed Transaction. The proposed board of directors of the
Resulting Issuer upon closing will comprise Dr. Charles Wiseman
(chairman), Dr. Saeid Babaei, Mr. Rahoul Sharan and Mr. Isaac B.
Maresky. The new management team will be led by Dr. Charles Wiseman
as Physician in Chief and interim Chief Executive Officer, and
Rahoul Sharan as interim Chief Financial Officer. Dr. Senthamil R.
Selvan will join the Resulting Issuer in the capacity of Senior
Scientist.
Dr. Charles Wiseman,
MD, FACP - Chairman and Physician in Chief
Dr. Wiseman is a highly accomplished oncologist with nearly 40
years of experience as a doctor. Dr. Wiseman began his medical
career as a Major in the U.S. Army Medical Corps. He became the
Director of the Breast Cancer Basic Research Lab at the University
of Texas' M.D. Anderson Hospital, one of the original 3 Cancer
Centers in the U.S. Dr. Wiseman pioneered chemotherapy treatments
for breast cancer that are considered the standard care of today.
At that time, he recognized the importance of genetics in breast
cancer biology. Considered irrelevant 30 years ago, today family
history and genetic analysis are accepted as fundamentally
important in the medical management of cancer. Additionally, his
previous work with monoclonal antibodies has benefited patients
with brain tumors.
He was the Principal Investigator on innovative treatment
protocols at the St. Vincent Cancer Treatment Center and the Los
Angeles Oncologic Institute, and participated in local and national
cooperative cancer treatment organizations such as the National
Surgical Adjuvant Breast and Bowel Projects ant the Southwest
Oncology Group. Dr. Wiseman is a Clinical Professor at the Division
of Medical Oncology, USC School of Medicine, and was Acting Chief
of Division of Oncology & Hematology at the White Memorial
Medical Center. Dr. Wiseman was also the Co-Director of the 2005
Palo Alto symposium on mathematical modeling of Cancer, a
conference sponsored by the American Institute of Mathematics.
Dr. Wiseman has authored more than 100 papers and medical text
book chapters. He has presented his research at such forums as the
American Association for Cancer Research, the Society for
Biological Therapy, and the American Association for Clinical
Oncology. His celebrated work on "Objective Clinical Regression of
Metastatic Breast Cancer in Disparate Sites after Use of Whole-Cell
Vaccine Genetically Modified to Release Sargramostim" is published
in the Breast Journal.
Dr. Wiseman draws patients from around the world and his peers
have elected him for inclusion in the Best Doctors in America® from
2001 to 2013. He has been listed in Cambridge Who's Who and in the
U.S. News & World Report's list of Top Doctors, from 1999 to
2013. Dr. Wiseman received his medical degree from the UCLA School
of Medicine, where he served as President of the Student American
Medical Association in his senior year. He received a B.Sc. in
Chemistry, also from UCLA, where he was designated the Outstanding
Senior of his faculty at graduation. Dr. Wiseman has sat on several
boards of directors, and has retained medical staff privileges at
Cedars-Sinai, St. Vincent Medical Center, Hollywood Presbyterian,
and LAC-USC Healthcare Center.
Dr. Saeid Babaei, PhD,
MBA - Director
Dr. Babaei is an accomplished entrepreneur with a unique
combination of experience in both the scientific and business
realms. He is currently the President & CEO of AbCelex
Technologies, a Toronto based Biotech Company focused in molecular
approaches to human and animal health. AbCelex has been successful
in securing a number of key strategic partnerships including a
collaboration agreement with Ireland's largest poultry processor as
well as an exclusive worldwide license agreement with Canada's
National Research Council's antibody platform for all in vitro
clinical diagnostic and food safety applications. Recently, Dr.
Babaei has successfully negotiated funding from a large US venture
capital fund to back AbCelex's lead program.
Prior to AbCelex, Dr. Babaei was the VP of corporate development
at Lorus Therapeutics, where he was largely responsible for helping
to turn around the company. During his tenure at Lorus, he
successfully assessed, negotiated, and closed several key strategic
transactions including out-licensing a Phase III cancer
immunotherapy program to a US-based biopharma, which resulted in
over $12mm upfront and potential milestone payment, high double
digit tiered royalty, and an equity investment in the Licensee.
Prior to Lorus, Dr. Babaei led corporate development activities at
Northern Therapeutics, where he played a key role for the launch of
the 'first' cell-based gene therapy clinical trial in patients with
pulmonary arterial hypertension. Northern was bought out by United
Therapeutics.
Dr. Babaei received his Ph.D. from the Department of Laboratory
Medicine & Pathobiology, Faculty of Medicine, University of
Toronto, as well as an Executive MBA from the Rotman School of
Management, also at the University of Toronto. Dr. Babaei sits on
several charitable boards, has lectured around the world, and has
been published well over 50 times.
Rahoul Sharan, CA -
Director
Mr. Sharan brings over 25 years of finance and accounting
experience to Ansell Capital Corp. He is responsible for managing
all of Ansell Capital's accounting and financial matters. Prior to
joining Ansell Capital, Mr. Sharan was a partner of the S&P
Group, which specializes in investment financing for venture
capital projects, real estate development and construction. At
S&P Group, Mr. Sharan has led the successful financing efforts
for over 15 companies in several industries totaling several
hundred million dollars' worth of transactions. Mr. Sharan is the
founder, chairman and director of Potash Ridge Corporation
(TSX:PRK), a Tier 1 issuer on the Toronto Stock Exchange. Mr.
Sharan is the President of KJN Management Ltd., which provides a
broad range of administrative, management and financial
services.
He also worked in public accounting for three years with Coopers
& Lybrand. At C&L, Mr. Sharan worked in both the tax and
audit groups for a wide variety of large and small clients. Mr.
Sharan holds a Bachelor of Commerce degree from the University of
British Columbia and is a member of the Institute of Chartered
Accountants of British Columbia.
Isaac B. Maresky -
Director
Mr. Maresky is a Principal with Sunel Securities, and is largely
responsible for identifying and bringing forth the BriaCell
opportunity. At Sunel, Mr. Maresky focuses on helping to seek out
and execute unique and attractive investment opportunities for the
firm and its investors. In that regard, Mr. Maresky has visited and
assessed assets and investment opportunities in several countries
around the globe, and to date has been involved in hundreds of
millions of dollars of transactions. Mr. Maresky is actively
engaged with Sunel's institutional investors and has published
research reports for clients internationally.
Previously, Mr. Maresky worked for Standard Chartered Bank as an
Analyst in their Mergers and Acquisitions group. There, Mr. Maresky
focused on the analytical side of the bank's mandates for large
corporate clients. Mr. Maresky began his financial career as an
intern with the Royal Bank of Canada in their Wealth Management
group, where he quickly became the top-performing intern of his
class. Mr. Maresky holds a degree from the Faculty of Health at
York University in Toronto.
Senthamil R. Selvan,
PhD - Senior Scientist
Dr. Selvan is currently serving as the Director of Immunotherapy
at Thomas Jefferson University in Philadelphia, ennsylvania. Dr.
Selvan received his undergraduate and master's degrees in Zoology
from the University of Madras, Tamil Nadu, India and PhD in Cancer
and Immunology from the Jawaharlal Nehru University in New Delhi,
India. Dr. Selvan was a post-doctoral fellow in tumor immunology in
the department of microbiology and immunology at Virginia Tech,
Blacksburg, Virginia in 1988. He moved to Duke University Medical
Center, Durham, North Carolina as a post-doctoral research
associate in the Department of Immunology, Duke University Medical
Center from 1989 to 1994. He also worked as a Principal
Investigator of transplant and tumor immunology in the Department
of Surgery at the Duke University Medical Center from 1995 to 1999.
During his tenure at Duke, Dr. Selvan served as Associate Member at
the Duke Comprehensive Cancer center. He left Duke in late 1999 to
become Senior Scientist of Cell Biology at the Hoag Cancer Center,
to direct tumor cell vaccine clinical trial and research programs.
He was promoted to Associate Scientific Director/Principal
Scientist in 2004 and directed the program at Hoag until 2009.
Dr. Selvan's research stems from a deep interest in cancer
immunology and immunotherapy. He was one of the first scientists to
develop an autologous human model to identify and characterize
tumor immune response and tumor-associated antigens recognized by
pancreatic tumor-specific T cells. His work extended to cancer cell
biology, personalized vaccine using autologous tumor cells, immune
monitoring of cancer vaccine, biomarkers of therapeutic response
and cancer progression, and botanicals of immunomodulators.
THE PROPOSED TRANSACTION
Ansell currently has 57,537,532 common shares issued, and
following the Ansell consolidation, will have 17,703,856 common
shares issued and outstanding. BriaCell has 10,000 common shares
issued and outstanding, which will be exchanged for 53,111,568
post-consolidation shares of Ansell.
As a condition of closing the Proposed Transaction, a private
placement (the "Offering") will be conducted of common shares of
BriaCell for gross proceeds of a minimum of $2 million or such
other form of equity or debt securities as is determined by
BriaCell, in each case to be concluded on terms and conditions
satisfactory to the market and subject to negotiations between
BriaCell and Ansell. Proceeds from the Offering will be used for
growth, research and development, and general working capital
purposes.
In that regard, the Company has retained Sunel Securities Inc.
and M Partners Inc., who will co-lead the Offering of at least
11,111,112 units at the price of $0.18 per unit, for aggregate
gross proceeds of at least $2 million. Each unit will be comprised
of one common share of the Resulting Issuer and one common share
purchase warrant. It is anticipated that each warrant will be
exercisable into one fully paid common share of the Resulting
Issuer for a period of 3 years from closing of the Proposed
Transaction, exercisable in the first 12 months at a price of
$0.25, and exercisable during the subsequent 24 months at a price
of $0.35. It is anticipated that a finder's fee on the transaction
may be payable.
Capitalization of the
Resulting Issuer
Following the completion of the Proposed Transaction but prior
to any shares issued in connection with the Offering there will be
approximately 71 million shares of the Resulting Issuer issued and
outstanding. Further updates will be made public as soon as the
terms of the Proposed Offering are finalized.
Sponsorship
Ansell intends to make an application to the Exchange for an
exemption from the sponsorship requirements in connection with the
Proposed Transaction. There is no assurance that such exemption
will be granted. Trading in the shares of Ansell is presently
halted. It is uncertain whether the shares of Ansell will resume
trading until the Proposed Transaction is completed and approved by
the Exchange.
Ownership of
BriaCell
BriaCell is a private company beneficially owned and controlled
by twelve registered shareholders of which a total of 8,318 common
shares, representing 83.18% of the issued and outstanding shares of
BriaCell are owned and controlled by its two largest shareholders,
Dr. Charles L. Wiseman (78.18%) and Randall C. Fink (5.00%). The
only BriaCell shareholder that will own more than 10% of the issued
and outstanding shares of the Resulting Issuer will be Dr. Charles
L. Wiseman, who will hold 41,522,623 shares of the Resulting Issuer
(58.63%), pre-Financing.
Conditions to closing
the Proposed Transaction
The completion of the Proposed Transaction and the Offering are
subject to the approval of the Exchange and all other necessary
approvals. The completion of the Proposed Transaction is also
subject to certain other additional conditions precedent,
including, but not limited to: (i) the entering into of a
definitive agreement by Ansell and BriaCell on or before May 15,
2014 (the "Definitive Agreement"); (ii) completion of satisfactory
due diligence by each of Ansell and BriaCell; (iii) the approval of
the Proposed Transaction by each of BriaCell's and Ansell's
respective board of directors; (iv) the approval of the
shareholders of BriaCell and Ansell; (v) completion of the
Offering; (vi) approval from the Exchange to list the Resulting
Issuer's shares; (vii) the absence of any material change or change
in a material fact which might reasonably be expected to have a
material adverse effect on the financial and operational conditions
or the assets of each of the parties to the Definitive Agreement;
and (viii) certain other conditions typical in a transaction of
this nature. All information contained in this news release with
respect to Ansell and BriaCell was supplied by the parties
respectively, for inclusion herein, and Ansell and its directors
and officers have relied on BriaCell for any information concerning
it.
READER
ADVISORY
Statements in this press release may contain forward-looking
information including, operating costs, administrative costs,
acquisitions and dispositions, capital spending, access to credit
facilities, income taxes, regulatory changes, and other components
of cash flow and earnings. Any statements that are contained in
this press release that are not statements of historical fact may
be deemed to be forward looking statements. Forward-looking
statements are often identified by terms such as "may", "should",
"anticipate", "expects" and similar expressions. The reader is
cautioned that assumptions used in the preparation of any
forward-looking information may prove to be incorrect. Events or
circumstances may cause actual results to differ materially from
those predicted, as a result of numerous known and unknown risks,
uncertainties, and other factors, many of which are beyond the
control of Ansell. The reader is cautioned not to place undue
reliance on any forward-looking information. Such information,
although considered reasonable by management at the time of
preparation, may prove to be incorrect and actual results may
differ materially from those anticipated. Forward-looking
statements contained in this press release are expressly qualified
by this cautionary statement.
The forward-looking statements contained in this press release
are made as of the date of this press release, and Ansell does not
undertake any obligation to update publicly or to revise any of the
included forward-looking statements, whether as a result of new
information, future events or otherwise, except as expressly
required by securities law.
THIS PRESS RELEASE, REQUIRED BY APPLICABLE CANADIAN LAWS, IS NOT
FOR DISTRIBUTION TO U.S. NEWS SERVICES OR FOR DISSEMINATION IN THE
UNITED STATES, AND DOES NOT CONSTITUTE AN OFFER TO SELL OR A
SOLICITATION OF AN OFFER TO SELL ANY OF THE SECURITIES DESCRIBED
HEREIN IN THE UNITED STATES. THESE SECURITIES HAVE NOT BEEN, AND
WILL NOT BE, REGISTERED UNDER THE UNITED STATES SECURITIES ACT OF
1933, AS AMENDED, OR ANY STATE SECURITIES LAWS, AND MAY NOT BE
OFFERED OR SOLD IN THE UNITED STATES OR TO U.S. PERSONS UNLESS
REGISTERED OR EXEMPT THEREFROM.
Completion of the Proposed Transaction is subject to a number of
conditions, including but not limited to, Exchange acceptance, and,
if applicable pursuant to Exchange Requirements, majority of the
minority shareholder approval. Where applicable, the Proposed
Transaction cannot close until the required shareholder approval is
obtained. There can be no assurance that the Proposed Transaction
will be completed as proposed or at all.
Investors are cautioned that, except as disclosed in the
management information circular or filing statement to be prepared
in connection with the Proposed Transaction, any information
released or received with respect to the Proposed Transaction may
not be accurate or complete and should not be relied upon.
THE TSX-VENTURE EXCHANGE HAS IN NO WAY PASSED UPON THE MERITS OF
THE PROPOSED TRANSACTION AND HAS NEITHER APPROVED OR DISAPPROVED
THE CONTENTS OF THIS PRESS RELEASE. NEITHER THE TSX-VENTURE
EXCHANGE NOR ITS REGULATION SERVICES PROVIDER (AS THAT TERM IS
DEFINED IN THE POLICIES OF THE TSX-VENTURE EXCHANGE) ACCEPTS
RESPONSIBILITY FOR THE ADEQUACY OR ACCURACY OF THIS PRESS
RELEASE.
Ansell Capital Corp.Rahoul SharanChairman of the
Board604-921-1898info@ansellcapital.com
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