Company Restructured - three business units: Medical, Pharmaceutical, and Consumer Product Divisions

 

Amarillo Biosciences, Inc. (ABI) is a Texas corporation formed in 1984 that engaged in developing biologics for the treatment of human and animal diseases. Such human disease research included influenza, hepatitis C, Chronic Cough in COPD, thrombocytopenia caused by other diseases and as a side effect of treatment of other diseases, and other disease indications using natural human interferon alpha that was administered in a proprietary low dose oral form.  ABI conducted more than 100 pre-clinical (animal) and human studies on the safety and efficacy of low-dose orally administered interferon.

 

The Company’s technology was quite unique in that the existing product on the market was injectable interferon which for some time has been FDA-approved to treat some neoplastic, viral and autoimmune diseases.  However, many patients experience moderate to severe side effects, causing them to discontinue the injectable interferon therapy. As stated earlier, ABI’s core technology is a natural human interferon alpha that is delivered into the oral cavity as a lozenge in low (nanogram) doses. The lozenge dissolves in the mouth where the interferon binds to surface (mucosal) cells in the mouth and throat, resulting in stimulation of immune mechanisms.  Orally delivered interferon has been shown to activate hundreds of immune system genes in the peripheral blood.  Human studies have shown that oral interferon is safe and effective against viral and autoimmune diseases. Oral interferon is given in concentrations 10,000 times less than that usually given by injection. The Company’s low dose formulation results in almost no side effects, in contrast to high dose injectable interferon, which causes adverse effects in at least 50% of recipients.

 

In 1996, the Company completed an Initial Public Offering (IPO) to become a publically traded corporation.  The Company made a leadership change in February, 2012, by electing Dr. Stephen T. Chen to become Chairman of the Board of Directors and Chief Executive Officer.  ABI continued on this research track until October, 2013, when it filed for protection under Chapter 11 of the U.S. Bankruptcy Code and emerged reorganized fifteen months later.  On January 23, 2015, the Final Decree closing the case was signed by Judge Robert L. Jones of the United States Bankruptcy Court for the Northern District of Texas in Case No. 13-20393-RJL-11.

 

The Company completely reorganized by employing an approach resulting in the elimination of over $4.7 million of debt and still left ABI with a number of important assets.  Additionally, to broaden and deepen ABI’s strategic and operating horizons, the Company was restructured into three business units:  the Medical, Pharmaceutical, and Consumer Product Divisions.  Historically, the Company has focused on R&D involving low-dose, orally administered lozenges containing interferon-alpha as a treatment for a variety of conditions.  Under the leadership of Dr. Chen, ABI began its new life with a valuable intellectual property portfolio including issued patents, a trademark, and a pending patent of which the claims for this new discovery have been favorably reviewed and are expected to be allowed and the patent issued late this year or early next year.  Additionally, ABI has a library of almost thirty years of scientific and clinical data on the human and animal applications of low dose oral interferon.  Through the Pharmaceutical Product Division along with technology and know-how available in the collection of intellectual property as well as the proprietary research history, ABI will out-license, or leverage, its core technology and form partnerships with other pharmaceutical companies to develop new discoveries and commercialize the resulting products.

An integral part of the ABI Operating Plan is to create multiple revenue streams through the implementation of in-licensing programs of novel medical and health care products and processes.  The Medical Division and Consumer Products Division will facilitate the enhancement of those revenue streams.  These in-licensing programs will be the catalyst which allows ABI to enter markets in Taiwan, Hong Kong, China, and other Asian countries for the distribution of these new medical and health care products.  Already, the Medical Division is preparing to deploy unique diabetic treatment centers in Taiwan beginning sometime in the third quarter of 2017.  These centers will provide a novel therapy for the management of Type 1 and Type 2 diabetes along with the reversal of the complications that historically accompany this insidious disease and plague patients.  This project would be the first in-licensed venture for the newly reorganized ABI.  Likewise, the Consumer Product Division is presently working on three major in-licensing endeavors.  First, this ABI division will offer a novel delivery system for nutraceuticals and food supplements such as Vitamin C.  Additionally, the delivery system can be topically used to administer quality skin care products.  Secondly, Consumer Products will import and distribute to the Asian markets a unique natural resource product which can be modified for human, animal, or agricultural applications.  Finally, ABI in conjunction with Hidden Valley Herbs, has entered the alternative medicine market through domestic and international distribution of natural Kentucky Wild Ginseng and other much-desired medicinal herbs.

The overall operating strategy is for ABI to create a world-wide network of strategic alliances capitalizing on advanced and emerging technologies in order to engineer a diversified enterprise having a major impact on every aspect of the healthcare and life sciences industries; and assemble an exhaustive pipeline of technologically-advanced, cutting edge products and services with which to compete in the American and Asian markets.  To support this strategy, ABI has opened its Asian Operations Center (AOC) in order to increase the Company’s presence in Taiwan and access growing Asian markets.

ABI is committed to expanding its business operations from the currently narrow focus in biotechnology to a wide variety of development opportunities in related industry sectors.  In addition to in-licensing discussed above, the Company will search for joint venture opportunities with both private and public companies.  The goal here is to acquire the desired business through acquisition of the target company with the ownership percentage being anywhere from 20% to 100%.  Joint-venturing with other companies will expedite growth and facilitate cash flow.

To continue a healthy but steady growth, ABI may periodically raise funds through public offerings, private placements, and strategic partner investments.  This funding will enable ABI to acquire other foreign businesses and bring those companies into the U.S. public markets.  ABI will utilize revenues gained through its ownership interests in these other companies to create consolidation synergies which will create even more growth.  When ABI became a public company in 1996, it was listed on the NASDAQ (exchange).  Due to the financial issues that plagued the Company, ABI dropped down to the Over-The-Counter – Bulletin Board exchange (OTC-BB).  The reorganization, recapitalization, and future growth will empower ABI to fulfill a long-time vision – to move from the OTC-BB back up to a listing on the NASDAQ.  The long-term mission is for ABI to monetize and commercialize its intellectual property and core technology to become an integrated healthcare enterprise of global distinction committed to amassing a cadre of innovative and state-of-the-art technologies, products, and services in the biotechnology, pharmaceutical, medical, and life sciences fields. 

Technology:    Non-toxic Interferon

Interferon is an immune modulator approved to treat some cancers, as well as viral and autoimmune diseases. AMAR has completed pre-clinical (animal trials) and human safety studies for its low-dose oral interferon product. The oral route of administration in humans uses a lozenge that is stable for up to 2 years at room temperature. Orally delivered interferon binds to mucosal cells in the mouth and throat, resulting in stimulation of the immune system through activation of hundreds of genes in the peripheral blood. Oral interferon is given in doses 10,000 times lower than injectable interferon, so side effects are virtually eliminated. AMAR owns or licenses 4 issued US patents related to this technology. 

Market Potential: $Billions

Treating influenza in the USA and big 5 countries in Europe represents a potential multi-billion dollar market. Influenza infects 10% of the world’s population and kills one million people per year.

Management

Stephen Chen, PhD, CEO and Chairman of the Board was formerly Director of Pharmaceutical R&D at Ciba-Geigy.  Bernard Cohen, MPA, CFO, has over 30 years of accounting and management experience.

Capital Structure

 

As of September 30, 2016, 20,594,810 common shares of stock are issued and outstanding with 5,119,207 shares reserved for stock options, warrants, and loan conversion. The shareholders have authorized 100,000,000 shares of common stock and 10,000,000 shares of preferred stock. 

Disclosure

This is neither an offering nor a solicitation of an investment in Amarillo Biosciences. Such an offering can only be made by means of the confidential private placement. Except for the historical information contained herein, the matters discussed are forward-looking statements that involve risks and uncertainties, including uncertainties related to product development, uncertainties related to the need for regulatory and other government approvals, dependence on proprietary technology, uncertainty of market acceptance of oral interferon and other risks detailed from time to time in the Company’s filings with the Securities and Exchange Commission. In particular, see “Item 1. Description of Business” and “Item 7A. Qualitative and Quantitative Disclosures About Market Risk” of the Company’s form 10-K for the year ended December 31, 2015.

The goal of AMAR

Based on its patented platform technology, the goal of the Company is to achieve FDA approval of its safe and effective low-dose oral formulation of human interferon alpha to treat multiple diseases.

What is interferon?

Scientists discovered an antiviral protein in 1957 and named it “interferon” because it interfered with the growth of flu virus in chick embryos. In 1987, the FDA granted the first approval for injectable interferon to treat hairy cell leukemia. Since then, injectable interferon has gained FDA approval to treat various cancers, as well as several viral and autoimmune diseases.

AMAR’s Pipeline for Human Health

Oral interferon has been tested and reported to be safe and beneficial in treating:

Influenza

Idiopathic pulmonary fibrosis

Chronic cough

Fibromyalgia

Chronic hepatitis C

Multiple sclerosis

Chronic active hepatitis B

Respiratory syncytial virus

Oral warts (papillomavirus)

Oral mucositis – cancer

Sjogren’s syndrome

Aphthous stomatitis

What is the market size for oral interferon?

The annual world market for human use of injectable interferon in 2009 was greater than $8 billion. The market is not yet developed for oral interferon. Low-dose oral interferon treatment of influenza in the US and EU is potentially a multi-billion dollar market.

What is special about AMAR’s oral interferon?

Comparison

Oral

Injectable

Dose

Up to 500 IU

Up to 10,000,000 IU

Side Effects

Rare/Mild

Common/severe

Treatment Cost

Cost Effective

Expensive

Administration

Lozenge/powder

Needle/syringe

Physician Visits

Infrequent

Frequent

Stability

Stable Room Temp

Refrigeration Required

 

How is AMAR’s interferon different?

Human interferon alpha is administered into the oral cavity in low doses (150 to 500 IU) as a small tablet (lozenge) that is allowed to dissolve in the mouth. Interferon binds to surface (mucosal) cells in the mouth and throat resulting in stimulation of immune mechanisms. Interferon is part of the first line of protection against infectious disease. Orally delivered interferon has been shown to activate hundreds of immune system genes in the peripheral blood. Studies have shown that oral interferon is effective against viral and autoimmune diseases. Since oral interferon is administered in doses 10 thousand times less than doses given by injection, side effects are essentially eliminated.

 

AMAR’S PRODUCT

AMAR’s orally administered interferon lozenge has the following advantages over marketed injectable interferon preparations: (1) it is given in low doses, making it less expensive, (2) it is convenient and easy to administer, and (3) it causes no side effects.

BUSINESS STRATEGY 

The Company is seeking global pharmaceutical partner(s) to fund development of low-dose oral interferon-alpha for the treatment of influenza and hepatitis C. From these global pharmaceutical partner(s), the Company expects to receive milestone payments during development and royalties on sales once commercialization begins.

INFLUENZA MARKET

Approximately 10% of the population worldwide develops symptomatic influenza each year. During a pandemic, the WHO estimates up to 25% of the population may be infected. The global influenza vaccine market was approximately $2.2 billion in 2006 and will exceed $4 billion by 2016 (www.datamonitor.com). BCC Research estimates the 2010 worldwide influenza market including antiviral drugs and vaccines is likely to reach $7 billion with average annual growth of approximately 20%.  

INTELLECTUAL PROPERTY

The Company owns or licenses 4 issued US patents relating to the manufacture or oral use of interferon. A patent owned by the Company provides market exclusivity for low dose interferon given in a patented oral formulation.

SUMMARY – AMAR’S INTERFERON-ALPHA LOZENGE

  1. Broadly patented platform technology.
  2. Formulation stable at room temperature for up to 2 years, safe and effective without significant side effects, easy to administer.
  3. Potential US & European markets for oral interferon treatment of various diseases exceed a billion dollars per year.
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