Ansell Capital Corp.
TSX VENTURE : ACP

Ansell Capital Corp.

April 17, 2014 14:29 ET

Ansell Capital Corp. Announces Proposed Reverse Takeover Transaction With BriaCell Therapeutics Corp.

VANCOUVER, BRITISH COLUMBIA--(Marketwired - April 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 Once the structure is determined, the letter of intent will be superseded by a definitive agreement between Ansell and BriaCell, and the parties will announce the signing of such definitive agreement and its general terms by news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.

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