VistaGen Therapeutics (VSTA) CEO Shawn Singh Provides Operational Update And Forward Guidance

May 24, 2012 5:37 PM ETVTGN
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VistaGen Therapeutics, the ingenious biotech firm advancing potentially game-changing technology via a spectrum approach that combines the company's Human Clinical Trials in a Test Tube™ platform with aggressive, novel chemical variation drug rescue of once-promising small-molecule drug candidates discontinued due to heart toxicity, recently offered a comprehensive update letter.

Penned by CEO of VSTA, Shawn Singh, the stockholder-directed letter provides a clear view from which to survey the impressive progress of the company since going public only a year ago. Singh noted that the current time is the most momentous for commercialization in the company's distinguished 14-year history of innovation, underscoring the judicious execution of R&D objectives made possible by the amassing of over $45M to date via strategic relationships, investments, and grants for the exciting technological breakthroughs the company has made.

Singh underscored important IP protection and strategic relationships with top biotech companies, as well as academic researchers, secured during the preceding year. Pointing to a clear crystallization of the underlying technologies, IP, and competencies, Singh seemed exuberant at the potential to not only fulfill the company's mission to "put humans first" (from a tech standpoint and philosophically), but accelerate shareholder growth in the process.

The beauty of the company's technology is that we literally have in vitro cell assay capability (2D/3D cell-based bioassay arrays) and the power to create "micro-organs" in a controlled environment that can then serve as a bench, or test-bed framework for handling drug rescue initiatives that otherwise just wouldn't be possible. VistaGen's Human Clinical Trials in a Test Tube™ platform is a product engine that can be employed for both in house and in partnered drug discovery and drug rescue programs across a wide range of diseases and conditions.

This capacity to rigorously evaluate response to new drug candidates in engineered human tissue offers a compelling workaround to animal/human testing, whose paradigm-shifting potential should be apparent. But just in case it isn't, let's express that potential in no uncertain terms by saying that this technology has the capacity to move truly clinically-relevant human biology from the end phase of the drug development process, right up to the front, so that rapid development/testing can be achieved with high fidelity and yet without risk to human patients.

In recent years a variety of conditions have collectively coalesced in the form of a massive barrier within the pharmaceutical sector, preventing new medicines from coming to market in an expedient fashion. From over half the volume of FDA approvals for new drugs disappearing in the last decade (despite massive infusion of R&D efforts by a host of pharma operators leading to a bevy of new offerings in the space), to the insurmountable hurdles often imposed by the pure logistical problems of accurately testing, to the exorbitant costs associated with development, it is a difficult era indeed in which to be advancing the state of medicine. However, VSTA remains undaunted and has the technological prowess to offer markets, developers, and ultimately patients in dire need of real solutions, a means to leap those hurdles and bypass those barriers, by bringing robust testing/evaluation into the lab at the front-end of the development process.

Moving forward, VSTA looks to leverage its sophisticated network of strategic relationships to pry open even more space in large market drug rescue, driving value to the shareholders while securing additional capital for momentum. The company has dialed in the laser-focus on drug rescue as well, narrowing the confinement beam to five key candidates with the highest potential of rewarding VSTA shareholders, while simultaneously advancing the overall business model. While focusing on securing requisite capital to launch the initial drug rescue program before the year is out, VSTA will be driving hard to also validate their liver toxicity/drug metabolism bioassay system, LiverSafe 3D™, during this first half of next year.

The success of CardioSafe 3D™ as a bioassay architecture in screening for heart toxicity in drug rescue targets mirrors that of LiverSafe 3D™, drawing on the same core cell technology expertise for which VSTA has come to be known throughout the industry. Exhaustive efforts invested in cultivating the company's "strategic drug rescue ecosystem of collaborators," are seen by Singh as having all been worthwhile, as the company positions itself to deliver shareholder value on the strength of the combined might of this collaboration ecosystem. Moving forward VSTA plans to launch a variety of CardioSafe 3D™ drug rescue programs targeting the large market product/operator area, as well as generate/license or sell a new lead drug rescue variant (from the initial programs) within the next year.

Singh has the fullest faith and confidence that VSTA's ingenious work will help major pharmaceutical players not only advanced powerful new therapies, but also save millions of dollars/hours of wasted development time, spent on otherwise great new therapies (with positive efficacy data) that without rescue end up wasted after all that expense (due to associated tissue toxicity issues).

Notably, VSTA plans to list the company's common stock on a major securities exchange in 2013, commensurate with the incredible development momentum achieved. Also slated for the coming year will be diligent work to complete Phase 1B of clinical development on VSTA's candidate for Parkinson's disease, epilepsy, depression, and neuropathic pain, AV-101.

All of the aforementioned goals are well within striking distance for VSTA once the necessary capital is secured, and thanks to the tight integration achieved by management with the company's strategic partners, VSTA is now able to punch well above its weight in advancing the stem technology and drug rescue-based commercialization initiatives.

The relationship established with one of Canada's biggest research hospitals, University Health Network, and Dr. Gordon Keller (one of the world's top minds in the stem cell field), has been successfully extended through September 2017, with the scope of the primary development collaboration also being significantly expanded. Likewise the 10-year relationship with Cato Research and Cato BioVentures has been expanded, now incorporating a right of first offer agreement for VSTA that will provide the company with better access to the large market drug rescue space that is so ideal.

VSTA also entered new collaborations this last year, including a medicinal chemistry collaboration agreement with Synterys to handle future expansion of drug rescue efforts, drug rescue research collaboration with Duke University that dovetails nicely with their leading work on cardiac stem cells (as well as electrophysiology and tissue engineering), and even a novel drug screening collaboration with Vala Sciences aimed at fusing Vala's high-speed kinetic imaging expertise, with VSTA's own engineered heart cell technology to radically advance screening methodologies for new drug candidates.

Needless to say, VSTA is incredibly well positioned and is aggressively seeking all necessary factors to obtain full commercialization potential.

To learn more about VistaGen Therapeutics, please visit the company's website at:

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