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structure is determined, the letter of intent will be superseded by a definitive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(R) 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.
FOR FURTHER INFORMATION PLEASE CONTACT:
Ansell Capital Corp.
Rahoul Sharan
Chairman of the Board
604-921-1898 (FAX)
info@ansellcapital.com
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