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AtheroNova: Small Biotech with Big Market Focus

AtheroNova (OTCBB: AHRO) is developing pharmacological compounds with the ability to dissolve fatty plaques for the regression and prevention of atherosclerosis.

Key Investment Considerations

$20+ Billion Market
Strong IP protection
Early stage creates opportunity to take advantage of low early stage valuation
Identifiable Milestones that can increase valuation
Potentially Lower risk of Safety or Efficacy problems than is typical in drug development
Potentially Greater Reward due to huge market
Strong Management team with successful track record

Overview

AtheroNova is a development stage biotech company focused on discovery, research, development and licensing of novel compounds to reduce or eliminate atherosclerotic plaque deposits. Atherosclerotic plaque which progressively blocks and narrows arteries is the main underlying pathology of cardiac disease and the leading killer in industrialized nations worldwide. The Company’s focus on compounds to reduce or eliminate atherosclerotic plaque deposits addresses the most lucrative segments of the multi-billion dollar prescription drug market: cardiology and stroke prevention.

Potentially Superior to Existing Standard of Care – Statins Ineffective at Reducing Plaque

Existing classes of atherosclerotic drugs including statins have demonstrated tremendous market success, rapidly achieving blockbuster status and billions of dollars in sales while not demonstrating any significant efficacy at reducing atherosclerosis at commonly used dosage levels.

Statins, including the biggest blockbuster of all time, Lipitor, with 2009 sales of over $7.5 Billion, reduce serum cholesterol, but do not effectively reduce plaque. Statins were developed, approved, and prescribed under the assumption that reducing the amount of cholesterol circulating in the bloodstream would slow or prevent the formation of atherosclerotic plaques of which cholesterol is a major component.

Current standard of care (statins) does not effectively reduce plaque
ASTEROID trial tested the maximum 40mg dosage of rouvastatin (Crestor) administered to subjects for two years and only demonstrated a 6.7% reduction in plaque
Drug eluting stents, catheterization and balloon angioplasty do not reduce plaque volume

AtheroNova has Potential to become the new Gold Standard in a $20+ Billion Market Segment

The enormous market success of statins is directly attributable to the fact that there are no competing options that directly reduce or eliminate plaque. The successful development of pharmaceutical compounds that directly reduce or eliminate plaque could become the new gold standard of treatment in the atherosclerosis treatment market that annually exceeds $20+ billion.

$20+ Billion Market

$14.3 billion 2009 Statin sales
211,000,000 prescriptions written in US in 2009
#1 Drug in the US is Lipitor with $7.5 billion in 2009 sales
$6 billion in drug eluting stents

Intellectual Property

AtheroNova has acquired the intellectual property for a class of naturally occurring compounds that have the potential to significantly reduce the incidence and severity of atherosclerosis by preventing the formation of atherosclerotic plaques and dissolving existing plaques. AtheroNova currently has 22 patent pending applications and has received a freedom to operate opinion from McDermott Will & Emery LLP, one of the leading Intellectual Property firms in the world.

Mechanism of Action

AtheroNova’s proprietary technology works by delipidization: the process of dissolving fats and cholesterol.

Safety and Efficacy

Safety and efficacy are the keys to winning regulatory approval. The preliminary work and underlying history that led AtheroNova to acquire the intellectual property for this class of compounds also provides some strong clues that may indicate that there may be cause for considerable optimism that these compounds pose far less risk of safety or efficacy problems than is typical of drug candidates at this stage of development.

The clue as to the potential efficacy of these compounds in human trials comes as a result of the existence of a human disease, Primary Biliary Cirrhosis (PBC) that serves as a model for the efficacy of AtheroNova’s compound. PBC is an autoimmune disease causing obstruction of the bile system in the liver resulting in the introduction of very minute amounts of bile acids into systemic arterial circulation.

PBC patient have a very low incidence of atherosclerotic plaque and the protection against atherosclerosis appears to be conferred by the presence of minute amounts of biliary acids in their blood stream.

The clues as to the potential safety of these compounds comes as a result of similar compounds already having demonstrated an extensive safety profile and winning regulatory approval when used in far higher concentrations than in AtheroNova’s applications.

The indications of efficacy in humans combined with a history of safety in humans is potentially a very strong indication of less development risk than is typical in biotechnology and is very rare at this early stage.

Safety

The compounds used in AtheroNova’s technology have a history of approval for use in humans by regulatory government agencies in a large number of developed countries throughout the world, including Germany, England, France, and Italy
Present in the liver and causes no damage to blood vessels at concentrations many orders of magnitude higher than being contemplated for use in treating atherosclerosis
Used in humans throughout the world, including in the USA, for their medical indications.
The existing human safety record for this class of compounds, at higher concentrations than AtheroNova used in their initial research, is well established.

Efficacy

Human Disease Model: PBC patients have a very low incidence of atherosclerotic plaque and the protection against atherosclerosis appears to be conferred by the presence of minute amounts of biliary acids in their blood stream.
Animal Disease Model: Hyper Biliary Mice (HBM) genetically altered to have a 3-fold bile acids increase in their blood have significant resistance to atherosclerosis.
AtheroNova’s PreClinical Animal Study: The results of AtheroNova’s initial preclinical study were recently released demonstrating the study group having a 95% less occurrence of arterial plaque compared to the control group.

Development Milestones Can Lead to Substantially Higher Valuations

AtheroNova has released a clear and distinct series of milestones for their drug development program. Typically in the biotech industry, as a company successfully advances through the drug development milestone pathway, valuations increase with each successfully completed step. As noted, with a potentially huge market and indications of safety and efficacy, the potential for AtheroNova to achieve successively higher valuations with each step in the development pathway is considerable.

Additional Medical Applications

In addition to the $20+ Billion atherosclerotic plaque market, AtheroNova’s compounds also have the potential to address additional multi-billion dollar pharmaceutical market segments.

AtheroNova has publicly identified the following additional medical applications for their compounds:

Localized reduction of subcutaneous fat deposits through transdermal application
Obesity
Hypertension
Diabetes
Peripheral Artery Disease (PAD)

Investment Summary

This small biotech going after a huge market has considerable potential to produce substantial gains for investors by achieving successively higher valuations with each step in the development pathway.

About AtheroNova

AtheroNova, through its wholly-owned subsidiary, AtheroNova Operations, Inc., is a development stage company currently researching novel patents-pending applications of certain natural compounds to regress atherosclerotic plaque deposits, a process called delipidization. The Company plans to develop multiple applications for its compounds, to be used in pharmaceutical grade products for the treatment of atherosclerosis.

Forward-Looking Statements

Except for historical information contained herein, the statements in this release are forward-looking and made pursuant to the safe harbor provisions of the Private Securities Litigation Reform Act of 1995. Forward-looking statements are inherently unreliable and actual results may differ materially. Examples of forward-looking statements in this news release include statements regarding the preclinical trials being conducted for the Company by UCLA and Cedars Sinai, the expected time to completion of the research, and the development of applications for AtheroNova's compounds. Factors which could cause actual results to differ materially from these forward-looking statements include such factors as significant fluctuations in expenses associated with clinical trials, failure to secure additional financing, the inability to complete regulatory filings with the Food and Drug Administration, the introduction of competing products, or management's ability to attract and maintain qualified personnel necessary for the development and commercialization of its planned products, and other information that may be detailed from time to time in AtheroNova's filings with the United States Securities and Exchange Commission. AtheroNova undertakes no obligation to publicly update or revise any forward-looking statements, whether as a result of new information, future events or otherwise.

AHRO Disclosure: Pentony Enterprises LLC entered into an investor relations consulting and market awareness contract on October 1, 2010 with the company. We expect to receive a total of eighteen thousand shares of restricted 144 stock. To avoid all potential conflicts of interest, we never sell shares into the open market during an active market awareness or investor relations program. This means that as we release new information about a particular client company either on our site or otherwise authored by us, you can be confident we are not selling shares at the same time. We hold no shares and will not be receiving further compensation in shares or that is share related during this period. Pentony Enterprises is not a registered investment adviser or a broker/dealer. Pentony Enterprises LLC makes no recommendation that the purchase of securities of companies profiled in this web site is suitable or advisable for any person, or that an investment in such securities will be profitable. In general, given the nature of the companies profiled and the lack of an active trading market for their securities, investing in such securities is highly speculative and carries a high degree of risk.