VANCOUVER, British Columbia, Dec. 3, 2014 (GLOBE NEWSWIRE) -- BriaCell Therapeutics Corp (TSX-V:BCT) ("BriaCell", the "Company", or "BCT") is pleased to announce that it has, effective December 1, 2014, completed its Go-Public Event onto the Toronto Stock Exchange Venture (the "Go-Public") and concurrent financing (the "Financing") (together referred to as the "Transaction") with Ansell Capital Corp ("Ansell"). The Company's shares are now trading under the symbol BCT. The terms of the Go-Public Event, which was structured as a Reverse Takeover ("RTO") under the rules and policies of the TSX Venture Exchange (the "TSX-V"), were previously announced by the Company in a release dated April 17, 2014. The Transaction was approved by 100.00% of shareholders. At a deemed value of $0.18 the Company's market value is approximately $15 million.
Regarding the Go-Public, Dr. Charles L. Wiseman, BriaCell CEO commented, "This marks a highly exciting time for BriaCell. Immunotherapies are quickly approaching the forefront in the fight against cancer, and we now have the ability to advance our unique technology, the BriaVax Vaccine. We plan to test the BriaVax Vaccine in our next Phase-I/II clinical trial. I look forward to reaching our next milestones on budget and on schedule."
BRIACELL BACKGROUND
BriaCell is a breast cancer immunotherapy biotechnology company. Immunotherapies have come to the forefront of the fight against cancer, because they harness the body's own immune system in recognizing and selectively destroying the cancer cells, sparing normal ones. Immunotherapies are believed to be a more targeted, less toxic approach to managing cancer. This approach is also more likely to prevent recurrence and is not expected to produce the serious side effects seen with chemotherapy.
BriaCell has spent over 10 years developing its patented vaccine technology, the "BriaVax" Vaccine. These efforts have demonstrated highly encouraging FDA Phase I safety and efficacy data in patients with advanced, Stage-IV breast cancer. Most uniquely, BriaCell has achieved these results in patients who had prior failed all other available therapies including various kinds of chemotherapy. In some cases, the lifespan was five times longer expected. The results were targeted, with little to no side effects, and were achieved rapidly, with regression occurring within 6 weeks.
In one patient, cancer regressed nearly completely in all sites to which the cancer had spread, including lesions in the breast, lung, and even brain. This result was the most unique finding, given that the brain is largely considered an untouchable site in terms of cancer regression. Again, results were seen rapidly and with little to no adverse side effects.
The Company is planning to advance its cancer immunotherapy technology in an approved FDA Phase I/II clinical trial with up to 24 breast cancer patients with advanced stages of solid tumors. 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. Although the focus of the Company is currently breast cancer, it recognizes that upon further proof of concept, its technology may be applicable to such other cancers as well. The Company intends on conducting significant research in order to determine how the "BriaVax" Vaccine has worked as well as it has on prior patients, with a focus on biomarkers and keeping an eye towards applying the Vaccine to differing cases in the future.
The upcoming Clinical Trial will be an Open-Label Trial, meaning that results will be available as they occur. This Clinical Trial may begin in as soon as 6 months, and BriaCell believes that positive results within the next 18-24 months (or sooner as further positive results are seen) in this Phase-I/II, would make it a very strong candidate for a licensing or partnership opportunity with a larger pharmaceuticals company to help aggressively advance the Vaccine into Phase-III and possible subsequent commercialization. Alternatively, the Company has the depth of expertise to organically advance its technology without a partnership, and may choose to do so if it poses more attractive returns for shareholders. BriaCell's team has overseen various successful Clinical Trials in the past, and believes in its ability to advance "BriaVax" as effectively as possible. For more information on the management team, please see below.
Also of note, the FDA has instituted a "Fast Track Status" for drugs demonstrating promise for patients with no other therapeutical options. In these cases, the FDA would become almost like a partner of the Company in order to expediently advance the drug through the regulatory process towards completion. BriaCell has had unique results in prior Clinical Trials, and believes that if it could replicate the positive results it has achieved in even only a handful more patients, "BriaVax" would be a candidate for such status. This could occur well before the trial is concluded, and would immensely speed up the Vaccine's development towards commercialization.
The Company has demonstrated unique and unprecedented results shown to date, and is intent on building upon these results to further advance "BriaVax" through the FDA Clinical Trials in order to help cancer patients with no other options.
COMPLETED FINANCING TO FUND UPCOMING CLINICAL TRIAL
In connection with the Acquisition, the Company completed a brokered private placement financing (the " Financing") with Agents Sunel Securities Inc and M Partners Inc, of common shares for aggregate gross proceeds of approximately $2.2 million based on the sale of 12,357,097 units at a price of $0.18 per unit on a post-Consolidation basis. The terms of the Financing were outlined in press releases dated April 17, 2014 and May 27, 2014. This $2.2 million is in addition to the approximately $1 million obtained through the Reverse Takeover itself. BriaCell now has sufficient capital to fund the Company through its upcoming Clinical Trial which is to include up to 24 additional late-stage breast cancer patients.
BriaCell CEO Dr. Charles L. Wiseman commented, "We decided to accept an additional small tranche of financing in order to include some very interested and supportive investors, who we feel share the long term vision of BriaCell. The capital raised, combined with the hospital partnership and royalty termination negotiated, leaves the Company in a favourable position to embark on its next clinical trial in order to treat up to 24 late-stage breast cancer patients."
HOSPITAL PARTNERSHIP AND EXTINGUISHED ROYALTY
In connection with the broader Transaction, the Company was also successful in negotiating the elimination of the royalty which had been held by St. Vincent Medical Center. St. Vincent is the longest-established hospital in the city of Los Angeles, and has been providing care to patients for more than 150 years. St. Vincent agreed to relinquish its royalty and instead become an equity holder directly alongside investors. BriaCell's "BriaVax" Vaccine and related intellectual properties are now 100% owned by BriaCell, free and clear of royalties or encumbrances.
The Company believes that this deal served to demonstrate a large institution's positive belief in the potential of the BriaVax Vaccine having. The hospital's choice to participate in the equity upside of the Company is a show of support in BriaCell's ability to execute on its strategy to build value through advancing its vaccine technology. The Company believes that owning its Vaccine outright, without any royalties, will ultimately have a substantially positive impact whether raising future capital or in pursuing potential partnership, licensing, and M&A opportunities.
BriaCell CEO Dr. Charles L. Wiseman commented, "St. Vincent has agreed to become an equity partner, demonstrating its long term belief in, and support for the advancement of our BriaVax Vaccine. It is our hope that eliminating the royalty will put us in a better position with regards to attracting other potential partnerships and further investment down the line." Sunel Securities acted as Advisor in connection with this agreement. The terms of this agreement were laid out in a press release dated July 15, 2014.
BRIACELL LEADERSHIP
BriaCell is led by a seasoned team of doctors, scientists, and financiers:
Dr. Charles Wiseman, Chairman & CEO, MD, FACP
Dr. Wiseman brings over 40 years of experience as an oncologist, having been published over 100 times in medical journals and medical text books. Dr. Wiseman has held leadership positions for a variety of hospitals and has led Clinical Trials for cutting edge drugs and treatments.
As the Director of Breast Cancer Basic Research Lab at the University of Texas' M.D. Anderson Hospital in the 1970s, Dr. Wiseman pioneered chemotherapy treatments for breast cancer that are considered the standard of care today. At that time he recognized the importance of genetics in breast cancer biology. Considered irrelevant and impractical 30 years ago, today family history and genetic analysis are accepted as fundamentally important in the medical management of cancer.
Genetic studies had been a natural link with his ongoing work with immunotherapy approaches to cancer management. At the time, cancer vaccines were at best considered to have a remotely possible effect, but again Dr. Wiseman foresaw the future application and begun working on the BriaVax Vaccine long before the recent influx of interest these therapies.
Dr. Wiseman received both his MD and B.Sc. from UCLA. Dr. Wiseman also served as a Major in the US Army Medical Corps.
Dr. Saeid Babaei, Director, PhD Biology
Dr. Saeid 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. 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 developing, recommending and implementing corporate M&A, IR/PR, licensing and strategic alliance strategies. During his tenure at Lorus, he successfully out-licensed a Phase III cancer immunotherapy program to a US-based biopharma company, which resulted in over $12 million upfront and potential milestone payment, high double digit tiered royalty, and an equity investment in the licensee.
Prior to joining Lorus, he was the Director of Business Development at Northern Therapeutics with proprietary adult stem cell-based gene therapy technology. At Northern, Dr. Babaei played a key role in establishing a partnership with United Therapeutics for the clinical development of the world's first 'stem cell-based gene therapy' for the repair of damaged lungs.
Dr. Babaei holds a PhD and an executive MBA, both from the University of Toronto. He has authored over 50 publications including research papers, conference presentations and patents.
Mr. Rahoul A. Sharan, Director and CFO, Chartered Public Accountant (CPA)
Mr. Sharan brings 25 years of finance and accounting experience to the BriaCell team. Mr. Sharan is currently the Chairman of the Board for Potash Ridge, a Tier-I Toronto Stock Exchange company which controls the largest Sulphate of Potash asset in North America.
Mr. Sharan is a Partner with S&P Group, where he has led financings in excess of several hundred million dollars. He was a Public Accountant for Coopers & Lybrand before it became PricewaterhouseCoopers in 1998.
Mr. Sharan holds a B.Comm from the University of British Columbia and is a Chartered Public Accountant.
Dr. Senthamil R. Selvan, PhD Cancer and Immunology
Dr. Selvan most recently served as the Director of Immunotherapy at Thomas Jefferson University in Philadelphia.
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.
Dr. Selvan holds a PhD in Cancer and Immunology from Jawaharal Nehru University in India, as well as a B.Sc. and M.Sc., both from the University of Madras in India.
Mr. Isaac B. Maresky, Director
Mr. Maresky is an investment banker with Sunel Securities, a Toronto based investment bank focused on identifying and executing unique and attractive investment opportunities for the firm and its clients. Mr. Maresky has assessed assets and businesses in several countries around the world.
Mr. Maresky was an early supporter of BriaCell, and was responsible for formulating a structure in order to take the company public while securing financing for its upcoming FDA Clinical Trial.
Previously, Mr. Maresky was an investment banking analyst for Standard Chartered Bank in the firm's mergers and acquisitions group. The group focused on mandates for mid to large natural resource corporations. Prior to that, he began his career with the Royal Bank of Canada in its wealth management group for an investment advisory practice.
Mr. Maresky sits on the Board of Directors for Bnei Akiva Private Schools in Toronto, as well as on the Board of Directors for YACHAD Canada, the National Jewish Council for Disabilities, a not-for-profit working with individuals with special needs.
Ms. Buu Nguyen, Regulatory Affairs, M.Sc. Clinical Sciences
Ms. Buu Nguyen leads the Regulatory Affairs division of BriaCell. Ms. Nguyen worked with Dr. Wiseman in the past on prior successful clinical trials, and subsequently joined a large-pharmaceutical company.
Ms. Nguyen has attained a wide range of industry experience, including with major pharmaceutical companies such as Allergan, Abbott Labs, and Eli Lilly.
She holds a Bachelor in Chemistry and Mathematics, as well as a Masters Degree in Clinical Sciences.
Dr. Lissette de Pillis, Advisory Board, PhD Mathematics
Dr. Lisette de Pillis is a mathematician who, together with Dr. Wiseman, published "A Validated Mathematical Model of Cell-Mediated Immune Response to Tumor Growth". BriaCell has a long time relationship with Dr. de Pills, and she has been identified to become a member of the Corporation's Advisory Board to assist on the mathematical side of the proposed Clinical Trial. Dr. de Pillis is currently the Mathematics Department Chair as Harvey Mudd College. She was the Principal Investigator for a National Science Foundation supported program mathematically modelling chemotherapies, immunotherapies, and vaccine therapies.
Dr. de Pillis is specialized in mathematically modelling cancer tumor growth and treatment protocols. She holds a PhD in Mathematics from University of California, Los Angeles.
Dr. Eli Gabayan, Advisory Board, MD
Dr. Eli Gabayan is the Chief of Medical Oncology at the Beverly Hills Cancer Center, and will serve an Advisor to BriaCell. Dr. Gabayan has remained avidly involved in multiple cancer research studies and clinical trials throughout a career that began at the University of Southern California School of Medicine.
Dr. Gabayan completed his internship and residency at University of California, Los Angeles where he also served as Chief Resident.
He received his Oncology and Hematology training at Cedars-Sinai Medical Center, where he remained as an attending physician in private practice with expertise in the areas of gastrointestinal, lung, breast cancers and multiple myeloma.
The TSX Venture Exchange Inc. has in no way passed upon the merits of the Company has neither approved nor disapproved the contents of this press release. Neither 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 release. This news release contains forward-looking information, which involves known and unknown risks, uncertainties and other factors that may cause actual events to differ materially from current expectation. Important factors - including the availability of funds, the results of financing efforts, the results of exploration activities -- that could cause actual results to differ materially from the Company's expectations are disclosed in the Company's documents filed from time to time on SEDAR (see www.sedar.com). Readers are cautioned not to place undue reliance on these forward-looking statements, which speak only as of the date of this press release. The company disclaims any intention or obligation, except to the extent required by law, to update or revise any forward-looking statements, whether as a result of new information, future events or otherwise. This press release 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 or elsewhere. These securities have not been, and will not be, registered in 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.
CONTACT: For further information:
BriaCell Therapeutics Corp
Isaac Maresky, Director
Phone: 416-227-9667
Facsimile: 604-921-1898
Email: info@BriaCell.com
