Market Opportunities and Investor Relations

Pherin Pharmaceuticals, Inc.is a clinical stage pharmaceutical company focused on maintaining the world leadership in the discovery and development of a new family of pharmaceutical compounds called pherines. These compounds are administered to the nasal passages and in turn have an effect on the hypothalamic and limbic areas of the brain. Our discovery of the effect of pherines and their link to the hypothalamus and limbic system enabled us to develop therapeutic drugs targeted against a variety of medical conditions associated with these brain areas. These medical conditions include anxiety disorders (Social Anxiety Disorder and Panic Attacks), mood disorders (Major Depression), Menopausal Hot Flashes, and Cognitive Impairment.

Pherines Represent a New Class of Pharmaceutical Compounds
We are focused on maintaining our world leadership in the discovery and development of a new family of pharmaceutical compounds called pherines. These compounds are delivered to the nasal passages and in turn affect the hypothalamus and the limbic system. Our discovery of the effect of pherines and their link to the hypothalamus and limbic areas has enabled us to develop therapeutic drugs targeted against a variety of medical conditions associated with these brain regions. These medical conditions are related to anxiety and mood disorders including Social Anxiety Disorder, Menopausal Hot Flashes, and cognitive function. We believe that this technology represents a substantial achievement as it unlocks large markets with products expected to offer numerous therapeutic advantages and convenient use to the patients.

Numerous Therapeutic Advantages
Pherine compounds are directly delivered to the nasal passages using a metered nasal spray. By virtue of the direct connections to the hypothalamus and limbic system and the ability of our compounds to act locally, pherines do not need to achieve systemic absorption and distribution. This provides a significant therapeutic advantage over traditional therapeutics targeted at the hypothalamus and limbic system that require access to systemic circulation and must cross the blood-brain barrier followed by uptake into the brain to exert effects. We believe the unique mechanism of action and method of delivery of pherines results in numerous therapeutic advantages, including:

    • rapid onset of efficacy
    • on-demand and long-term administration available
    • ultra low dose
    • excellent safety and tolerability profile

We believe these therapeutic advantages will result in pherines becoming an important new class of therapeutic compounds.

Large Market Opportunities
The market for drugs that target the hypothalamus and limbic system is large and diverse. Among our lead compounds that have completed or are in the final stages of Phase 3 clinical trials are: Aloradine IN for the acute and also adjunct treatment of Social Anxiety Disorder which is placed third among psychiatric disorders behind depression and substance abuse, and addresses a market estimated to be over $1 billion annually; PH10 for acute treatment of depression, the most frequent psychiatric disorder, which addresses an annual market of about $10 billion; Salubrin-HF NS, for the acute management of menopausal hot flashes and other symptoms of menopause, which affect up to 80% of menopausal women and addresses a market estimated to be $3 billion annually.

We have additional compounds in development that are targeted at large market opportunities such as PH10 nasal spray for acute treatment of depression, and PH15 nasal spray for acute cognitive enhancement, which await additional financial resources to advance their development.

Strong Product Pipeline
We have a diverse product portfolio that we believe increases the probability of our commercial success. Currently we have drug candidates that are in Phasse 3 clinical trials for Social Anxiety Disorder, Phase 2 clinical trials for Premenstrual Disorders and Menopausal Hot Flashes. In addition, we have a strong pipeline of Pherine compounds that await research screening and selection. Our pipeline of products addresses the following indications:

    • Social Anxiety Disorder
    • Depression
    • Menopausal Hot Flashes
    • Cognitive Improvement

Strategic Partnerships
Pherin business development efforts are focused on collaborative relationships with forward-looking and technically advanced companies. Details on Pherin’s partnership opportunities are available from our Executive Vice-President, lmonti@pherin.com.

Strong Patent Position
Our patent portfolio covers the composition; method of use and delivery systems of pherine compounds and includes patents and patent applications that cover over 1,000 Pherine molecules. We have 26 U.S. patents and foreign patents issued or allowed.

 

Key Elements for Advancement

    • Intellectual Property
    • Large Market Opportunities
    • Strong Product Pipeline
    • Strategic Partnership
    • Strong Patent Position

We have a diverse product portfolio that increases the probability for commercial success. We believe that the therapeutic advantages of our products will result in pherines becoming an important new class of approved pharmaceutical.

Pherin Product Development

We believe that our technology represents a substantial achievement as it unlocks large markets with products expected to offer numerous therapeutic advantages and convenient use to the patients. As our clinical candidate pherines advance in the development process we have begun building a commercial infrastructure to support what we hope will be a growing portfolio of approved pharmaceutical products.

 

Intellectual Property

Pherin has filed worldwide patent applications covering various aspects of its technology. Twenty-six patents covering pherine compounds have been allowed in the United States and 76 internationally. Pherin’s patents and patent applications create a library of over 1,000 pherine molecules with the potential for pharmaceutical activity.

Pherin Pharmaceuticals has recently received notice of issuance from the US Patent Office and other countries throughout the world for its patent applications covering Social Anxiety Disorder. Menopausal Hot Flashes, and has patents pending for depression and cognition improvement.

Patents and patent applications cover novel compounds, therapeutic compositions, method of use, and receptor genes and delivery systems. Opportunities for additional patent coverage are assessed and pursued as an integral part of the Company’s core activities.

 

Louis Monti, MD, PhD
Julian N. Stern
Kevin McCarthy
Donald S. Robinson, MD
Toby Rosenblatt
Roberto Rosenkranz, PhD

Michael L. Liebowitz, MD
Ellen Freeman, PhD
Roger Whiting, PhD
Gustavo Garcia de la Mora, PhD
Jose Vicente Diaz Sanchez, MD, PhD