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Tuesday
08Sep2009

ImmunoBiotics, Inc. (OTC BB: IMBI) 

1062 Calle Negocio, Suite C

San Clemente, CA 92673

www.ImmunoBiotics.com

www.LutiMax.com

“The face of neurodegenerative disease is the same no matter what the disease is called.”  Tom Lahey, Co-founder of ImmunoBiotics.

ImmunoBiotics, Inc. (OTC BB: IMBI) is a nutraceutical company that develops, manufactures, licenses, and sells patented dietary supplements for the treatment and prevention of neurodegenerative, autoimmune, and metabolic diseases including ALS, Autism, Parkinson’s disease, and other neurological diseases. The founders have developed and patented their LutiMax® product, which is an extensively developed, highly researched, and clinically proven formulation of the bioflavonoids Luteolin and Rutin. Luteolin and Rutin are plant pigments found in fruits and vegetables and are proven to have significant health benefits, but they are difficult for the body to absorb. The LutiMax® product results in significantly better absorption of Luteolin into the bloodstream. As a result, inflammation is reduced in tissues and organs with restoration of function and tissue repair. LutiMax® is made entirely of naturally occurring substances and are a supplement to the diet. These bioflavonoids have been proven in hundreds of studies published in internationally recognized medical and scientific journals to help treat the symptoms of many autoimmune disorders, inflammatory diseases, allergies, and neurodegenerative diseases.

In human clinical trials for Lou Gehrig's disease (ALS), LutiMax® has shown significant improvements in lifespan and quality of life. Additionally, in informal human trials, LutiMax® has shown improvements for Autism, Multiple Sclerosis, Lupus, Fibromyalgia, and diabetes. The Company owns a broad U.S. patent with 110 claims that was developed by the founders.

China - LutiMax® has been tested in China as a product and therapy for almost five years. During this time ImmunoBiotics has been collaborating with Chinese clinical test facilities and working closely with doctors and hospitals to validate the efficacy and explore market possibilities for LutiMax® in China. These include the Chinese military hospital network of 180+ hospitals with three battleships, many provincial governments, and the Central Government.

The Author is the Father of an Autistic Child - The author of this report, Michael Sweeney, is the father of an Autistic 11 year old son – Dustin Sweeney. Dustin’s recent progress with LutiMax comes later in this report. Both Michael and his wife Katie Sweeney are strong advocates in the Autism community. Katie Sweeney focuses much time and effort on the Biomedical dimension of Dustin’s therapy. She recently stated to Tom Lahey, Co-Founder of ImmunoBiotics, “I just want to say from a mom’s perspective, after four days, the change is phenomenal.  We’ve been on this roller coaster for a long time and I abandoned hope for a silver bullet long ago.  It is all trial and error and what works on one person, may not on another.  So we have become very good at the “wait and see” approach. Right now, I am just overjoyed that he is not in pain.  It’s one thing for him to be Autistic, that we accepted long ago.  It’s another thing to watch your child experience torturous rages that tear your heart out. This has solidified in my mind the viewpoint that we are dealing with inflammation (as our DAN doctor has been suggesting all along) and that introducing heavy doses of an anti-inflammatory has a positive effect. I’m anxious to learn more about this and figure out with you how to commercialize it to the mainstream Autism and DAN community.”

Investment Highlights:

  • Great patient demand for effective therapies in neuro-degenerative and autoimmune markets in the prime markets of the U.S. and China. Other countries will follow.
  • Competitors are unable to duplicate the bioavailability of this patented product, which creates significant barriers to entry.
  • A natural product that can improve health and mitigate illness with no effective treatments available.
  • The consumer market is shifting toward natural and organic products/remedies versus prescription drugs.
  • LutiMax® reduces inflammation and keeps the body from fighting/attacking itself.
  • Licensing opportunities in 5 sectors internationally.
  • Nutraceutical/dietary supplement is available without a prescription.
  • Company has a strong patent with 110 claims, 14 years to run; Chinese patent pending.
  • Potential viral marketing opportunities through Autism groups and parents, YouTube, blogs, social media and social networking sites.

Financial Information:

The Problem:

The incidence of neurodegenerative disease is increasing due to many factors including an aging baby boomer population with increasing longevity and long term exposure to environmental toxins.  Stress and the 20th century Western diet, which lacks adequate bioflavonoids and antioxidants from green vegetables, leave the human body prone to hyperimmune reactions and unable to properly regulate inflammation.  The result is chronic inflammatory and neurodegenerative diseases with significant increases in Autism, Parkinson’s disease, Fibromyalgia, and Alzheimer’s disease.  Allergy, asthma, autoimmune disease and chronic inflammation are also on the rise due to the lack of green vegetables in the diet that contains bioflavonoids. LutiMax® provides these essential bioflavonoids.

There is a great and growing demand for effective autoimmune, metabolic, and neurodegenerative disease therapies throughout the world.  The therapies that are available are often very expensive, have limited efficacy, and are often accompanied by significant undesirable side effects.  Additionally, there are highly restrictive drug and regulatory hurdles that vary from country to country that are complex, time consuming, and require expensive compliance in order to bring a therapy to market.

A Scientific American study from January 2008 estimates the market size for dietary supplements like LutiMax® to be in excess of $22 billion per year.  Autoimmune and neurodegenerative diseases are widely considered incurable and affect over 10% of the United States population.  Projections are similar for other industrialized nations.

LutiMax® is an effective treatment for the common underlying mechanism for all neurodegenerative and autoimmune diseases which is chronic inflammation from an overactive immune system. The broad-spectrum efficacy of LutiMax® in neurodegenerative diseases compares to no other pharmaceutical compound or nutraceutical in the world today. Some examples of LutiMax®’s efficacy include a total remission of 38 and 53 year old males with ALS (now 47 and 60, respectfully) and significant improvement in many other ALS patients (clinical observations by Dartmouth Hitchcock ALS Center neurologists).

LutiMax® improves the quality of life for a majority of autoimmune and inflammatory human ailments in Lupus, Fibromyalgia, Multiple Sclerosis, and Rheumatoid Arthritis.  All of these cases described were with patients that were unable to get relief from their symptoms with prescription drugs under the care of their physicians.

The LutiMax® product line is composed of entirely natural dietary ingredients discovered and developed by founders, Thomas P. Lahey and V. J. “Dr. Raj” Rajadhyaksha, PhD.  The patent was issued in 2004 and it covers 5 specific novel compounds and many compositions known as bioflavonoids, including LutiMax®. These bioflavonoids have been proven in hundreds of studies published in internationally recognized medical and scientific journals to effectively prevent and treat the causes and symptoms of many autoimmune disorders, inflammatory diseases, allergies, and neurodegenerative diseases.

Method of Action – How LutiMax works

LutiMax® blocks the first step of immune activation that leads to chronic inflammation using one of the one of the most powerful antioxidant and anti-inflammatory formulations known to man.  Mast cells, T Cells and immune signaling molecules that are often responsible for excessive and prolonged inflammation are calmed down to allow the body to heal itself.  Free radicals that induce aging, inflammation, and reduce the ability to make energy are blocked and neutralized.  The result is more energy to heal the body so it can operate at optimal health.

The LutiMax® formula improves the absorption of Luteolin and the time Luteolin lasts in the body.  This substantially increases the ability of the Luteolin to reach the cells that need it most. LutiMax® products are easily administered orally as lozenges, tablets, or capsules, and eliminate the need for painful and inconvenient injection of insulin or other medications such as beta interferon or other drugs.

The LutiMax® products are now and will continue to be supported by the positive and encouraging results of scientific trials being conducted with clinical partners along with the increasing awareness by the collective medical research community. LutiMax®  is the focus of the following human clinical studies:

  • For ALS (Lou Gehrig’s Disease) at Dartmouth’s Hitchcock ALS Center,
  • Pending clinical trials in Lung Cancer Prevention at Emory University,
  • Pending clinical trials in Autism at Thoughtful House,
  • Pending clinical trials for Autism at the University of South Florida,
  • Ongoing studies at the Sino/Japan Friendship Hospital in Beijing testing on patients with Parkinson’s disease and Lupus.

Product Sales and Distribution of LutiMax®

ImmunoBiotics will approach the market with the following three strategies:

  1. Direct sales via the Company’s website and phone sales to retail clients and commercial distributors.
  2. License LutiMax® formulations covered by the Patent to nutraceutical companies and distributors and possibly drug companies for their sale of ImmunoBiotics products and to receive royalty payments from the sales of such products.  The products may be re-branded or relabeled and may contain different formulations for the market and or therapeutic approach chosen by the licensee.
  3. Close on distribution agreements with companies such as GNC Nutrition. In addition to carrying the LutiMax® market companies may also choose to re-brand the product and use a different formulation than the standard LutiMax® product. 

The Company also manufactures Race Day Fuel®, a superior sports performance enhancing product (clinically proven ingredients) that performs better than any other product on the market.  ImmunoBiotics would be required to spend millions to break into the sports drink market, which is dominated by Coca Cola®, Pepsi®, and Cadbury Schweppes. As a result, a licensing strategy for this product is preferred by management.

The Market for LutiMax® Family of Products

In the Neurodegenerative disease market:

  • Approximately one in every 100 children is on the Autism Spectrum
  • ALS sufferers number 30,000 with 5,000 newly diagnosed patients per year
  • 2.5 million people are afflicted with Parkinson’s Disease
  • Alzheimer’s disease affects over 4 million people
  • 750,000 are victims of stroke every year, and
  • 3.7 million endure Fibromyalgia

Autoimmune disease affects approximately 5% of the total population:

  • 1.5 million with Lupus
  • 2.5 million with Rheumatoid Arthritis
  • 5.5 million with Psoriasis
  • 400,000 with Multiple Sclerosis
  • 30,000 new children each year with Type 1 Diabetes

Metabolic diseases affect the largest segment of the population with 18-36 million people with Type II Diabetes while 50% of the total population is overweight or obese and are more prone to develop Diabetes.

First Focus is on Autism

The initial market focus for LutiMax® will be in southern California for children on the Autism spectrum. This will be followed by an expansion into major markets nationwide utilizing key third party endorsements by industry leaders that have direct experience in the benefits of ImmunoBiotics products in treating Autism and Autism spectrum disorders.  Beginning in 2010, the Company will focus on ALS, Parkinson’s disease, and Fibromyalgia markets using the same approach.

The Autism community arose out of a desperate unmet need to diagnose, understand, treat, and care for children and their families affected by Autism.  Autism is a rapidly escalating epidemic in the United States and in most industrialized nations.  It affects at a minimum 1,000,000 children and their families in the United States.  Recent estimates of greater than 1 in 100 children being affected are conservative with up to 1 in 50 children in highly polluted areas.  The economic and social impact of Autism to our country’s infrastructure and society is devastating and cannot be overstated.

ImmunoBiotics has video or written reports from parents documenting the dramatic improvements in the treatment of over a dozen pediatric Autism cases and two adult cases with 100% of the cases responding to LutiMax®.  This unprecedented success rate is the result of a research and science-based product designed to treat autism as a whole body or systemic disease affecting more than just the brain.  LutiMax® treats the metabolic, immunologic, digestive, vascular, and neurologic systems of people affected by Autism. It affects many if not all of the deregulated biochemical pathways.

ImmunoBiotics is engaging parents, physicians, researchers, educators, media, and politicians to make a difference in defeating autism.  To accomplish this, they have created the position of Ambassador to Autism - distinct from a typical scientific advisory board or director to bridge the gap between corporate governance and structure of the company to the Autism community. The Company’s Ambassador to Autism is Mrs. Pat Grayson-DeJong, who is a nationally recognized expert in Autism education and serves on the Board of Directors of Autism Speaks, LA.  Pat’s personal experience with LutiMax® and her 40 year-old son affected by Autism is the foundation for her enthusiastic participation in ImmunoBiotics to introduce LutiMax® to the Autism community.  It is through Pat that the Company is actively establishing a foundation of grass roots support and use within the Autism community beginning in Los Angeles and surrounding Southern California. Other pathways into the Autism Community include:

  • Autism Physicians and Therapists – Focus on Defeat Autism Now (DAN) doctors to evaluate their patients’ response to LutiMax®
  • Autism Researchers and Clinical Trials - Based on existing relationships with research groups in university and clinical settings such as the Silver Children’s Development Center at the University of South Florida (USF) and The Thoughtful House (www.thoughtfulhouse.org).  Pending trials with these groups will provide the clinical proof of independent, double-blind clinical trials supporting the use of LutiMax® in the treatment of Autism.  The first trial is expected to begin within 90 days of receipt of funding.
  • Media Driven Marketing in Autism - ImmunoBiotics will utilize the public relations firm of Levenson and Brinker to provide high value product positioning. ImmunoBiotics also has a relationship with Ms. Sidney Clifton of Sanctuary Enterprises, the mother of a 26 year-old son with Asperger’s Syndrome. (Asperger’s is on the Autism Spectrum.) Her son has experienced dramatic improvement using LutiMax®. Ms. Clifton is a media and spokesperson agent for many celebrities and professional athletes. 
  • Political Support of LutiMax® for Autism - Harvard University School of Public Health published in 2006 that the average costs associated with the care of an Autistic child exceeds $3.1 million per child in their lifetime.  This does not even consider the social costs borne by the families and the rest of society including supervision, lost wages, and special education costs and breakup of the family infrastructure. With a minimum of 1 million children and up to 1.5 million children with Autism, this equates to $3.1 to $4.6 trillion dollars.  

Dustin Sweeney: Time line of introduction and use of LutiMax®

Patient: Dustin Sweeney, 11 year old Autistic boy, son of Michael Sweeney the author of this report and Katie Sweeney, who is very active in Biomedical approaches to treat Autism.

What it is: LutiMax® is the molecular complex of Luteolin and Rutin. Luteolin and Rutin are Super-Nutrients from a class of naturally occurring plant molecules known as bioflavonoids.  Luteolin and Rutin (and it’s metabolite Quercetin) neutralize free radicals such as superoxide, the hydroxyl radical, and other reactive oxygen compounds to help reduce oxidative stress and reduces inflammation, immune activation, regulates hyperactive immune systems, and promotes healthy carbohydrate metabolism. 

Background: Michael Sweeney discovered LutiMax® and met ImmunoBiotic’s Co-Founder Tom Lahey at a conference in New York in May, 2009. While the Company had instant credibility from the author’s perspective by association with ImmunoBiotics “Ambassador to Autism” Mrs. Pat Grayson-DeJong from the Board of Directors of Autism Speaks (www.autismdefender.com) and a mother of an adult Autistic man, Michael Sweeney remained somewhat skeptical about the effect of LutiMax® in the treatment of Autism. Autism is a complex subject with continual conflicting reports on a variety of therapies.

LutiMax® is introduced on Wednesday August 5, 2009: After a very stressful weekend and a number of bad days at school, Mike Sweeney had a conference call with Tom Lahey on Wednesday morning. The following game plan was set-up:

Starting Wednesday August 5th we used 3 LutiMax® capsules 4 times a day. Thursday August 6th was a better but not perfect day at school. Friday August 7th got even better. On Saturday, we took Dustin on a 2 hour drive to Lake Compounce, a crowded amusement park. He had only two incidents all day. One on the car ride, and one at the park when it got extremely crowded at the end. In both instances, he was able to self regulate himself back to “normal” which is typically something that is very difficult for him. On Sunday, Mike was able to play golf (not what I was expecting to be able to do back on Wednesday!) and Katie took Dustin and Dylan (our older son) to a restaurant for lunch and then to our pool club for swimming and dinner. No incidents all day! On Monday, August 10th (this morning), he was slightly agitated and seemed hot (Dusty often feels hot but does not have an actual fever), so we gave him L-Theanine, Advil and LutiMax® and he quickly regrouped and got on the bus and rode to school without incident.

I am not expecting miracles and Dustin is still Autistic, but his behavior turnaround in the past twelve days is extraordinary. This is a single case study, and reflects only our initial experience with LutiMax® in our son with Autism. It is the only product we have ever used that has given us the hope that will let Dusty function off of medications such as Risperdal, a drug that he has been on now for 5 years. Our goal is to see The Real Dusty again, but we will take it one day at a time for now.

Social Media and New Media Marketing

LutiMax products are therapeutic and need to be exposed to the market in the most inexpensive and effective means possible.  Many if not most people afflicted by autoimmune diseases and many other diseases are constantly searching the Internet for news relating to advancements in therapies. The ImmunoBiotics market is made up of the numerous people that find their information through not only individual searching but through communities and social media.

In order to get this message out and establish their brand, ImmunoBiotics will employ the tactics and strategies that promote LutiMax® results, an online library of test and trial results, videos, testimonials from product users, and blogs from founders, clients, and medical professionals who use and believe in the Company’s products. ImmunoBiotics will also create a blog on the LutiMax® website that is regularly updated along with question and answer forums and the above described supporting tests, studies, and trial results along with related research and development for the treatment of these diseases by partners such as Defeat Autism Now, Generation Rescue, and The Organization for Autism Research.

LutiMax in China

The Company has completed studies in China on the effectiveness and safety of the LutiMax® formula for Parkinson’s disease in rats and mice.  These tests are recognized by the Chinese medical community as valid because they were completed, regulated and independently controlled in Chinese test facilities and hospitals and did not rely on tests previously conducted in the United States.

ImmunoBiotics President Dan Smith and Founder Tom Lahey have made multiple presentations to different governmental and medical groups several times over the past five years in China and have addressed large groups of doctors, scientists, nutraceutical and pharmaceutical industry groups. The LutiMax® product is well known and highly regarded in China and it has helped many people.  The Company is in the final stages of securing a patent in China for LutiMax® and related compounds. There are three significant market entry points in the Chinese Market for ImmunoBiotics:

  1. Getting approval as a Class One Drug - The single biggest difference between the US and China is the drug approval process. While LutiMax® is considered a nutraceutical, health food or supplement in the United States, in China the product is considered a drug. This method is the most costly and time consuming approach, but when completed it will have the biggest impact as far as revenue. A class one drug in China has a period of seven to ten years of government authorized market protection that prevents a competitor from making it or selling it. Fortunately for ImmunoBiotics, the cost in China including testing and clinical trials and time to get approval is much less expensive and much more rapid than America. Immunobiotics has identified a Chinese joint venture partner in Zhongshan.
  2. Sell directly to Hospitals - The second path is to sell directly to hospitals for re-sale only to their patients with neurological diseases. This path and process is a way to get to market using a Chinese regulation that allows hospitals to test new products in their own hospital. However, patients or other people can come to the hospital and ask for LutiMax® and the hospital can provide it to them as outpatients. The time to market for this approach is 6 to 18 months.
  3. Doctor’s Clubs - The third method is to sell directly to physicians through a “doctor’s clubs” (these are like US medical or dental specialty associations with more emphasis on commerce) as a form of dietary supplement known as a Health Food.  The time to market for this approach is three to nine months.  

2009 Nutraceuticals Market  

Functional foods and dietary supplements promise consumers vitality and good health. The nutraceuticals market itself is enjoying much the same effects. Those wanting to adopt healthier lifestyles, prevent illness or manage their weight are increasingly turning to the nutraceuticals - or health ingredients - market. The sector has huge potential, and despite the global economic downturn and its significant impact on consumer spending, there still appears to be cause for optimism. "The market has grown very healthily; there's been phenomenal double-digit growth in the past few years, albeit from a very small base," says Anna Ibbotson, industry manager, chemicals and materials at global consultancy Kline & Company.

Management Team

Tom Lahey – COO, Chairman of the Board, and Founder - Mr. Lahey has twenty-five years of professional experience as a chemist. His experience includes synthetic organic chemistry, natural products chemistry, polymer chemistry, environmental chemistry, drug design, neuroimmunology, oncology, and environmental consulting.  He began his career in chemistry at the University of California, San Diego. The current focus of Mr. Lahey’s work is to bring to market the LutiMax® product line in specific niche markets including neurodegeneration such as Autism, Parkinson’s Disease, ALS, Multiple Sclerosis and autoimmune diseases such as Lupus, Psoriasis, Diabetes, and Rheumatoid Arthritis.

In 2001, Mr. Lahey founded SYNORx, Inc. with his partner Dr. V. J. Rajadhyaksha to patent and commercialize the use of Luteolin and related bioflavonoids in autoimmune diseases, diabetes, ALS, cancer, allergies, asthma, neurodegenerative diseases, inflammatory conditions, and obesity. Mr. Lahey and Dr. Rajadhyaksha filed three patent applications in the United States that were issued in 2004 as a single, consolidated 110-claim patent.  Several international patents are pending.  Mr. Lahey designed and built a custom chemical manufacturing facility and developed four distinct commercial products utilizing the patented technologies. 

Daniel Smith – CEO - Dan brings significant executive experience, skill and abilities including international sales, marketing and distribution planning, concept development, implementation, budgeting and general management. He has a proven record of developing and implementing solutions to international, multidimensional complex operational problems. He has provided consulting services traveling extensively between China and America in developing joint ventures with government, public and private companies with a primary focus in the area of health and wellness. Dan brings those abilities and all-important relationships to ImmunoBiotics. Dan is presently traveling to China on a regular basis overseeing ongoing testing, making presentations to the Chinese medical community and closing successful negotiations for an ImmunoBiotics and Zhongsan Province joint venture.

Dan founded his own company in 1998 to develop health products made in America, and introduce them into the China market. During that time he developed strategic relationships with government, and private and public companies in China. He has established several distribution channels, and successfully entered the China market. He has successfully developed and managed realty and mortgage investment companies and is Member American Academy of Anti-Aging Medicine.

V. J. “Raj” Rajadhyaksha, PhD – CFO, Secretary and Treasurer - Dr. Raj has a strong academic and business background with a Ph.D., Organic Chemistry, 1968 Swiss Federal Institute of Technology (E.T.H.), Zürich, Switzerland (With Nobel Laureate Professor Vladimir Prelog) and an M.S. in Organic and Pharmaceutical Chemistry, and a B.S. in Chemistry, 1961, University of Bombay, Bombay, India.

He retired as a seasoned senior member of University of California, Irvine’s Office of Technology Alliances.  He has extensive experience with the identification and patentability of marketable technologies, and the aggressive commercialization through licensing with a comprehensive knowledge of patent law and patent processes. He has excellent negotiating skills as exemplified by having structured, negotiated and closed substantive deals within the fields of biotechnology and pharmaceuticals. Dr. Raj has served as a scientific and technical advisor to a venture capital firm and angel investors on emerging technologies and has a passion for science and discoveries for public benefit. He has co-founded three pharmaceutical start-up companies; two were acquired for $55 million (1987) and $12.5 million (1995), respectively. Dr. Raj is credited with over 50 US and foreign patents and authored numerous publications and is recognized worldwide for design and development of novel penetration enhancers and topical, transdermal and ocular drug delivery systems.

Scientific Advisory Board

  • V. J. Rajadhyaksha, PhD (see above)
  • Michael J. Powell, DO, Internal Medicine and Rheumatology, The Fibromyalgia Treatment and Learning Center, Sacramento, CA
  • Elijah W. Stommel, MD, Department of Neurology, Dartmouth Hitchcock ALS Center, Dartmouth School of Medicine
  • Charles R. Timson, MD, Family Practice, Huntington New York.

 

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