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Share Name | Share Symbol | Market | Type |
---|---|---|---|
Claritas Pharmaceuticals Inc | TSXV:CLAS | TSX Venture | Common Stock |
Price Change | % Change | Share Price | Bid Price | Offer Price | High Price | Low Price | Open Price | Shares Traded | Last Trade | |
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0.00 | 0.00% | 0.025 | 0.025 | 0.035 | 0 | 01:00:00 |
Dear Fellow Shareholders,
Claritas is well on its way to becoming the industry leader in nitric oxide therapeutics.
Nitric oxide is one of the most promising molecules in medicine, however, for reasons I will discuss below, its full potential has never been realized. Our drug, R-107, holds the key to unlocking the full potential of nitric oxide, and I, believe R-107 is the only drug in development that is capable of doing this. R-107, is a patented nitric oxide-releasing compound.
The challenge for any biotech company is to demonstrate that its products are safe and effective. This challenge is difficult. More than 90% of all new drugs fail, because they are found to be either unsafe or ineffective.
However, where there is high risk, there can also be high reward, and, if a new drug is approved for a large commercial market, the rewards will be substantial. This is exactly why we are developing R-107.
I have spent the past 30 years of my career in the biotech industry. I have seen drugs fail, and I have seen drugs succeed. At Claritas, we are mitigating the risk of failure by focusing on nitric oxide, a molecule we know to be safe, and we are focusing on the rewards of success by targeting large commercial markets where we know nitric oxide can be effective.
After 30 years in this business, I have never been as optimistic as I am now. I believe that R-107 has potential to transform nitric oxide therapy from a niche treatment to a mainstream therapy in several large market indications.
I frequently hear from investors who want to better understand our chances for success. I will address some of their questions below.
Why am I so Optimistic Regarding the Potential for R-107?My optimism is based on the exceptionally positive data we have seen with R-107 in animal models of pulmonary arterial hypertension (“PAH”) and in sepsis, as well as the data we have seen from Massachusetts General Hospital with nitric oxide in treatment of COVID-19 infection. Based on these data, I believe R-107 will be successful in all of the above indications. However, it is R-107’s potential in PAH that I am most excited about.
I am excited about our chances for success in PAH for the following reasons: (1) the data we have with R-107 are far superior to similar data seen with other drugs in this disease; (2) the commercial opportunity in PAH is large; and (3) we have a plan to monetize this program in the near-term, within the next 18-months, through an out-license or sale to a larger pharmaceutical company.
We can create the greatest value in the shortest time in PAH, and I will explain below why this is so. At the same time, we will also make progress with R-107 for treatment of sepsis and vaccine-resistant COVID-19 infection.
What is The Opportunity in PAH?PAH is a life-threatening disease characterized by a profound elevation in blood pressure in the arteries of the lungs. Approved drugs can only ease the symptoms of the disease and slow its progression. PAH is fatal, and there is no cure.
What Will the Company do in the Short-Term?In the short-term, we will complete the Phase 1 study with R-107, to be followed by multiple Phase 2 Studies. The purpose of the Phase 1 study is to demonstrate that R-107 is safe for human use. The purpose of the Phase 2 studies is to demonstrate that R-107 can be developed as a nitric oxide therapy in multiple large market opportunities, such as PAH, sepsis, and vaccine-resistant COVID-19 infection.
We will complete the Phase 1 study later this year, and, based on the extensive investigations undertaken in the preclinical setting with R-107 which demonstrated that it was well tolerated in multiple species, and, taken together with the fact that nitric oxide is a molecule produced naturally by the body, we have every reason to believe that R-107 will be found to be safe and well tolerated in man.
Following the Phase 1 study, we will initiate Phase 2 studies in multiple indications, including the Phase 2 Proof of Concept in PAH.
What is Nitric Oxide, and Why do I Believe R-107 Nitric Oxide Therapy has Great Potential? R-107 is a nitric oxide-releasing compound that can be administered orally in a capsule, or by nasal spray, or by injection.
Nitric oxide is produced by many cells throughout the body. It is produced in small amounts where it is needed, and it is essential to maintain health. Its function in the body is to heal many types of infections, disorders and disease.
Nitric oxide acts within the cardiovascular system to keep blood vessels healthy and regulate blood pressure. It acts within the immune system to eliminate or disable bacterial and certain viral infections. It is also active in many chronic conditions and diseases (such as chronic inflammation, erectile dysfunction, dermatological disorders and cancer).
Nitric oxide has been the subject of intense medical research. It was the subject of the 1998 Nobel prize in medicine, and more than 130,000 published scientific and medical papers have been published regarding its biological functions.
Much of this research has focused on nitric oxide as a potential pharmaceutical therapy. However, the full potential of nitric oxide as a pharmaceutical has not been realized.
Why Hasn’t the Full Potential of Nitric Oxide Been Realized?The historical challenge with nitric oxide therapy has been the difficulty of delivering the molecule in an effective and practical manner.
Nitric oxide exists as a gas that must be stored in large, pressurized cylinders. These cylinders are cumbersome, expensive, and potentially dangerous when moved around.
Furthermore, because nitric oxide is a gas, it must be delivered by inhalation therapy requiring use of a CPAP-like device and administration by trained respiratory therapists.
For these reasons, use of nitric oxide gas use is expensive, complex, and cumbersome, and its application has therefore been quite limited.
Our drug, R-107, is a liquid nitric oxide-releasing compound. R-107 was designed to solve the problems associated with nitric oxide gas.
What Advantages Does R-107 Have Over Nitric Oxide Itself?R-107 is a nitric oxide-releasing compound. Unlike gaseous nitric oxide, R-107 is a liquid that can be administered orally in a capsule, or by nasal spray, or by injection. Whereas the advantages of liquid R-107 over gaseous nitric oxide in ease of administration are obvious, this is far from the whole story. R-107’s important medical advantages over nitric oxide include the following:
What Is Our Approach? How Will R-107 Be Used?Our approach is to supplement the body’s natural production of nitric oxide with additional nitric oxide that will be delivered by our drug, R-107.
The idea of delivering supplemental nitric oxide is not new. There are other nitric oxide releasing compounds, such as nitroglycerin. However, these other compounds rapidly induce tolerance and lose biological activity after more than a single dose. In contrast, R-107 does not lose its potency, even after prolonged periods of use.
With R-107, we have found a way to supplement the body’s own nitric oxide defense system, and we can do this in a simple patient-friendly manner with a drug that will not lose potency after a single dose.
Who Are the New People You Added to The Team?
It was important for me, in turning the company around and making it a world leader in our space, to bring in the very top people in the nitric oxide field. I was fortunate in being able to assemble such a group.
Today we are led by our new independent Board members: Professor Salvatore Cuzzocrea, an internationally renowned expert on nitric oxide who has published more than 600 papers on nitric oxide and worked closely as an advisor with the team that designed and invented R-107, and Professor Perenlei Enkhbaatar, who is an internationally acknowledged expert and leader in the biology of nitric oxide and acute lung disease, including PAH.
In addition, we have added Dr. Garry Southan as head of our Scientific Advisory Board. Dr. Southan is an internationally renowned authority in the biology, biochemistry, and chemistry of nitric oxide, and the author of more than 100 peer-reviewed scientific publications and 25 patents relating to nitric oxide. He was also a member of the team that designed and invented R-107.
With the leadership and guidance of this group, we will move quickly to advance R-107 in treatment of PAH, as well as in vaccine-resistant COVID-19 infection and sepsis.
Our Financial Strategy – Strengthening Our Balance Sheet, and Utilization of Non-Dilutive Financing Sources
Delivering Results and Focusing on 2021 and Beyond: With R-107, Claritas will unlock the true potential of nitric oxide therapy. We have brought together a team of internationally renowned experts in nitric oxide science, and our goal is to position the Company as the leader in nitric oxide pharmaceuticals. Our goal for 2021 is to complete our Phase 1 study in Australia demonstrating that R-107 is safe in humans. From there we will drive value in 2022 as we branch out into Phase 2 studies in PAH, vaccine-resistant COVID-19 infection, and sepsis. Beyond 2022, the Company could expand in a number of clinical directions. Nitric oxide is produced throughout the body in response to many types of infection, disorders, and disease, and Claritas plans to work with its partners to address all of these opportunities.
I will look forward to keeping you updated on our progress.
Sincerely,
Robert E. Farrell, J.D.President and CEOClaritas Pharmaceuticals, Inc.www.claritaspharma.com
About Claritas PharmaceuticalsClaritas Pharmaceuticals, Inc. is a clinical stage biopharmaceutical company focused on developing and commercializing therapies for patients with significant unmet medical needs. Claritas focuses on areas of unmet medical need, and leverages its expertise to find solutions that will improve health outcomes and dramatically improve people's lives.
Cautionary StatementsNeither TSX Venture Exchange nor its Regulation Services Provider (as that term is defined in the policies of the TSX Venture Exchange) accepts responsibility for the adequacy or accuracy of this release.
This press release may contain certain forward-looking information and statements ("forward-looking information") within the meaning of applicable Canadian securities legislation, that are not based on historical fact, including without limitation in respect of its product candidate pipeline, planned clinical trials, regulatory approval prospects, intellectual property objectives, and other statements containing the words "believes", "anticipates", "plans", "intends", "will", "should", "expects", "continue", "estimate", "forecasts" and other similar expressions. Readers are cautioned to not place undue reliance on forward-looking information. Actual results and developments may differ materially from those contemplated by these statements depending on, among other things, the risk that future clinical studies may not proceed as expected or may produce unfavorable results. Claritas undertakes no obligation to comment on analyses, expectations or statements made by third parties, its securities, or financial or operating results (as applicable). Although Claritas believes that the expectations reflected in forward-looking information in this press release are reasonable, such forward-looking information has been based on expectations, factors and assumptions concerning future events which may prove to be inaccurate and are subject to numerous risks and uncertainties, certain of which are beyond Claritas’ control. The company’s name change has not yet been affected and the company believes that it will affect the name change subject to regulatory compliance as soon as practicable after this news release. The forward-looking information contained in this press release is expressly qualified by this cautionary statement and is made as of the date hereof. Claritas disclaims any intention and has no obligation or responsibility, except as required by law, to update or revise any forward-looking information, whether as a result of new information, future events or otherwise.
Contact InformationRobert FarrellPresident, CEO(888) 861-2008info@claritaspharma.com
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