MSI Methylation Sciences Inc

Presenter: Barry J. Guld, President & CEO

Company Profile

Methylation Sciences (MSI or the Company) is a CNS company focused on developing molecules which have clinical proof of concept but which have yet to be exploited in the major pharmaceutical markets. The first molecule, s-adenosyl methionine, commonly referred to as SAMe, has a large body of human evidence as an effective treatment for depression.
MSI has multiple generations of formulations with superior qualities which can provide potential partners with several development strategies. MSI's lead, MSI-190, is ready for Phase II development. The product has been reviewed by the FDA in a pre-IND meeting. The FDA has indicated that MSI may proceed with its planned Phase II trial.

Compared with currently approved, alternative antidepressant drugs (MAO inhibitors, TCAs, SSRIs etc.), MSI-190 has a number of clear-cut benefits and advantages, including the following:
Equal efficacy to current antidepressants;
Fewer side effects;
Novel mechanism of action;
Reduced clinical risk due to extensive knowledge of the molecule and available clinical proof of concept and safety data;
Ability to penetrate the 50% of Major Depressive Disorder sufferers who currently do not take an Rx.
The Company is seeking to raise an additional $15 million to fund the Phase II development program for MSI-190. Following the successful conclusion of the Phase II trial, the Company will seek maximize the potential for its product and investors by partnering or/and exit through partnership with a large biotechnology or pharmaceutical company. This event is within 24 months of the next round of financing.

Company Strategy

Developing a compound with compelling, physician-sponsored clinical evidence is an established business strategy in the biotechnology space, exemplified by companies such as KOS and Reliant Pharmaceuticals. SAMe is an excellent target for reformulation with its proven record of safety and efficacy. Risk, clinical timelines and expenses can be significantly reduced due to the nature and history of the compound, which also serve to shorten the time-to-market and reduce the capital investment required relative to conventional drug development.

Intellectual Property

MSI's intellectual property portfolio is focused on the ability to control the release of the molecule throughout the GI tract and other attributes which show beneficial results with respect to clinical outcome. The initial patent family (original filing, two subsequent CIPs and national filings) covers an extended release formulation of s-adenosyl methionine. Since that time, the company has expanded its portfolio to include two additional US provisional applications for the human in vivo work which represent a unique understanding of the molecule arising from R & D and clinical observations (yet unpublished).

The portfolio is modeled after other successful formulation patents which have been upheld in the Orange Book. The patents when issued have long lives projected to at least 2027 and 2028.

Investors

GrowthWorks Capital Ltd.
Lions Capital Corp.
Angel

Management Team

Barry J. Guld, President & Co-Founder Co-founder, Zadall Systems Group (McKesson); Director of SecureRF and investor in private Healthcare companies.
Steve Targum, MD, Chief Medical Officer Consultant in Psychiatry, Massachusetts General Hospital; Former Professor of Psychiatry and Vice-Chairman of the Department of Mental Health Sciences, Hahnemann University School of Medicine.
David MacDonald, PhD, VP Product Development Former CEO, Active Pass Pharmaceuticals and General Manager, Biovail Contract Research Division.
Nancy Harrison, Chief Business Officer & Co-Founder Former Senior VP and Partner, Ventures West (Financed Angiotech, AnorMed, SemBioSys).

Presenter Bio

Barry J. Guld, President & Co-Founder Co-founder, Zadall Systems Group (McKesson); Director of SecureRF and investor in private Healthcare companies.

Contact

MSI Methylation Sciences Inc
108, 4475 Wayburne Drive
Burnaby
BC, Canada
V5G 4X4

ph: 604-435-5155
fx: 604-435-5110

www.msimethylationsciences.com
bguld@methylationsciences.com

April 6-8, 2010