ADVANTAGES

     Relative to other drugs, we believe that the costs of getting our drug to market will be inexpensive, and believe the likelihood of approval is high, particularly given: (i) the unique mechanism of action of our drug, (ii) its limited, non-chronic dosing, (iii) its safety, and (iv) the deficiencies of the current gold standard pharmaceutical treatments (SSRIs) for anxiety disorders.  We anticipate peak annual sales in the $300M to $500M range. 

1.  Our drug is safe.  

• We dose at 1/20th (i.e., 5%) of the FDA-approved typical daily dosage for treatment of tuberculosis.

2.  Our drug is effective.  

• Successful human clinical trials reported in five different anxiety indications (PTSD, SAD, Panic, OCD, and Specific Phobia).

3.  Our drug targets under-served clinical needs with large market opportunities.

• >20 million Americans afflicted with anxiety disorders.

• Current treatments (psychotherapy and drug therapy) are imperfect:
• Psychotherapy is effective, but often very slow and expensive for patients.
• SSRIs (e.g., Xoloft, Paxil) are the pharmaceutical gold standard, but are often ineffective and plagued with bad side effects.  For example, see recent Newsweek article.

4.  Our approach is unique, unlike anything else in the field. 

• Our drug actually makes psychotherapy more efficient.

• Rather than targeting physiological symptoms of the affliction, we target a psychological cure.

• Targeted indications include anxiety disorders, depression, and addiction.

 5.  We anticipate shortened regulatory approval via FDA's 505(b)2 pathway.

• DCS is FDA-approved (at much higher doses) for treatment of TB.

• Reduced CMC risk - partnership with FDA-approved manufacturer of DCS.

6.  We have a strong IP Position.

• Three issued U.S. patents including broad claims to critical IP.
• Pending international applications, allowance in Europe, issued patent in Australia, pending in Canada.
  

      We intend to develop D-cycloserine as a branded pharmaceutical for treatment of anxiety disorders and other related afflictions, and recently conducted a pre-IND meeting with FDA.  Our development efforts are focused exclusively on D-cycloserine (DCS), a drug that has been approved for many years for the treatment of tuberculosis.  In the U.S., DCS is not widely used and is not available as a generic.  Importantly, the effect of DCS on learning consolidation occurs at low doses of DCS which are not currently approved by FDA.  DCS is very safe at the low doses we utilize, which correspond to about 5% of the typical daily DCS dose for tuberculosis treatment.  We can rapidly enter human clinical trials after filing an IND, and anticipate a relatively short development cycle utilizing FDA’s 505(b)2 process.  

FINANCIAL PLAN  

     All-in estimate through NDA approval is $35M or less. 

      The company was founded by Emory University professors Michael Davis, Ph.D., and Kerry J. Ressler, M.D./Ph.D., along with Extinction Pharmaceuticals CEO Jason P. McDevitt, Ph.D. 

                               PARTNERS/INVESTORS 

      - Hurley Consulting Associates, Ltd.

      - CIT GAP Fund