Advaxis, Inc. (ADXS)
Advaxis is a clinical-stage biotechnology company developing the next-generation of immunotherapies for cancer and infectious diseases. The company's immunotherapies are based on a novel platform technology that uses live, bio-engineered bacteria to secrete an antigen/adjuvant fusion protein that redirects the powerful immune response all human beings have to fight off cancer and disease.
The company has more than fifteen distinct constructs in various stages of development, all of which are involved in strategic collaborations with recognized centers of excellence such as the National Cancer Institute, Cancer Research – UK, the Wistar Institute, the University of Pennsylvania, the University of British Columbia, the Karolinska Institutet, and others.
Advaxis’ lead construct, ADXS-HPV, is currently in Phase 2 clinical development for recurrent/refractory and advanced cervical cancer, CIN 2/3, and HPV caused head and neck cancers. This important construct was recognized as the Best Therapeutic Vaccine (approved or in development) at the 5th Annual Vaccine Industry Excellence (ViE) Awards by the vaccine industry and the journal Expert Reviews of Vaccines.
The estimated global market for immunotherapies is projected to exceed $37.2B by 2012, with cancer vaccines forecast to grow into an $8B market. Protected by 77 issued and pending patents, Advaxis is extremely well positioned to capitalize on the burgeoning opportunities in the healthcare sector as it advances the development of next-generation treatments for today’s most challenging diseases.
Chanticleer Holdings, Inc. (HOTR)
Chanticleer Holdings owns and operates Hooters® branded restaurants in emerging international markets. As one of the most well-known restaurant brands in the world, Hooters has a menu that consists of moderately-priced American bar food and the world-famous Hooters girls. The company has ownership interests in the parent company of the Hooters brand, Hooters of America (HOA), four Hooters restaurants in South Africa, one restaurant in Hungary, one Hooters restaurant in Australia, and the exclusive franchise rights to develop and operate Hooters restaurants in three of the most populous states of Brazil: Rio De Janeiro, Minas Gerais, and Espirito Santo.
The first Hooters® restaurant opened October 4, 1983, in Clearwater, Florida. Today there are more than 430 Hooters restaurants in 28 countries. During its history, Hooters has continued to rank high amongst the industry's growth leaders. The Hooters concept has stayed true to its roots with its beach-themed concept, logo, uniform, menu and ambiance being similar to what existed in its original store, and has proven successful in small-town America, major metropolitan areas, and internationally.
In 2011, Chanticleer (NASDAQ: HOTR; HOTRW), together with a group of major private equity investors, acquired Hooters of America (HOA) and its largest franchisee Texas Wings, Inc. Today HOA is the Atlanta-based operator and the franchisor of over 430 restaurants in 28 countries. Chanticleer has rights to develop and operate restaurants in South Africa, Hungary, and parts of Brazil, and has joint ventured with the current franchisee in Australia, while evaluating several additional opportunities.
Chanticleer's core growth strategy involves expanding the Hooters® brand in emerging markets and other rapidly developing global economies. The rising number of middle class consumers in emerging markets is driving the demand for recognized international brands. Targeting underpenetrated international markets with proven market success, the company aims to achieve consistent, above-average growth rates and favorable financial returns for its shareholders.
VistaGen Therapeutics, Inc. (VSTA)
VistaGen Therapeutics is a biotechnology company applying stem cell technology for drug rescue and cell therapy. Drug rescue combines human stem cell technology with modern medicinal chemistry to generate new chemical variants ("drug rescue variants") of once-promising drug candidates that have been discontinued during late-stage preclinical development due to heart or liver safety concerns. VistaGen also focuses on cell therapy, or regenerative medicine, which includes repairing, replacing or restoring damaged tissues or organs.
VistaGen's versatile stem cell technology platform, Human Clinical Trials in a Test Tube™, has been developed to provide clinically relevant predictions of potential heart and liver toxicity of promising new drug candidates long before they are ever tested on humans.
By more closely approximating human biology than conventional animal studies and other nonclinical techniques and technologies currently used in drug development, VistaGen's human stem cell-based bioassay systems can improve the predictability of the drug development cycle and lower the cost of new drug research and development by identifying product failures earlier in the cost curve. According to the Food and Drug Administration even only a ten percent improvement in predicting failure before clinical trials could save $100 million in development costs, which savings ultimately could be passed on to patients.
Using mature human heart cells produced from stem cells, VistaGen has developed and internally validated CardioSafe 3D™, a novel three-dimensional (3D) bioassay system for predicting the in vivo cardiac effects of new drug candidates before they are tested in humans. VistaGen is now focused on using CardioSafe 3D™ to generate up to two new, safer small molecule drug rescue variants every twelve to eighteen months. VistaGen anticipates that these drug rescue variants will be modified versions of once-promising new drug candidates that have been discontinued by pharmaceutical companies and academic research institutions because of heart toxicity concerns, despite substantial prior investment and positive efficacy data demonstrating their potential therapeutic and commercial benefits. In most cases, VistaGen plans to license or sell its new, safer drug rescue variants in strategic partnering arrangements with global pharmaceutical companies, arrangements providing VistaGen with both near term and downstream milestone payments and economic participation rights but without future development cost obligations.
AV-101, VistaGen's lead small molecule prodrug candidate, has successfully completed Phase I clinical development in the U.S. for treatment of neuropathic pain, a serious and chronic condition affecting millions of people worldwide, depression, and other neurological diseases and conditions. To date, the U.S. National Institutes of Health (NIH) has awarded VistaGen over $8.75 million for development of AV-101. Management anticipates strategically out-licensing AV-101 to a development and marketing partner in 2013.
VistaGen is also developing LiverSafe 3D™, a novel predictive liver toxicity and drug metabolism bioassay system for drug rescue applications. In parallel with drug rescue activities, the Company is funding early-stage nonclinical studies focused on potential cell therapy applications of its Human Clinical Trials in a Test Tube™ platform.