There are a handful of investment opportunities we review every year that stand out above the rest. At Pinnacle, we know that Stellar Biotechnologies (KLH:TSXV)(SBOTF:US OTC), our new client and Featured Company, is at the top of that list. In this report we will explain exactly why we believe this to be the case.

Important fact to note and the key to Stellar’s future:

Stellar lays claim to a protein used in cancer vaccines and appears to be the only company world-wide with a renewable, reliable source to create that protein.

Stellar Biotechnologies is the provider of a valuable biomedical protein known as “KLH” – which Stellar appropriately named its Canadian ticker symbol after. KLH is used as an essential carrier protein in vaccines under development for cancer, hypertension, arthritis, and other serious diseases. This protein is extremely rare in the world and commands prices as high as $200,000 per gram for medical-grade material.

KLH is a potently immunogenic (i.e. a substance that induces an immune response) high-molecular-weight protein – it’s a giant molecule. It offers an ideal carrier molecule for vaccine antigens (i.e., substances that promote the generation of antibodies) against cancers and infectious agents. Don’t worry if you didn’t understand much of that, initially, neither did we. We will explain in more understandable terms exactly what Stellar’s KLH protein is, just how rare and valuable it is, how its process works and most importantly, the opportunity for investors.

What makes Stellar’s KLH protein so unique is that it can be sourced from the blood of only one rare sea animal, the California Keyhole Limpet. The Keyhole Limpet can only be found off the coast of central California to Northern Baja, and Stellar’s headquarters and aquaculture facility is based right in the center of those locations.

 

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Key Facts:

* Stellar is the only company in the world with a proprietary technique of extracting the KLH protein from the Keyhole Limpet without killing it (the key to Stellar Biotechnologies – it has intellectual property (IP) to create a renewable source of KLH).

* Stellar appears to be the only company in the world with a multi-million dollar aquaculture center that is fully-scalable and home to thousands of Keyhole Limpets.

* The value of KLH, depending on the grade, sells for between $4,000 and $200,000 dollars per gram.

* Stellar has over 70,000 spawned and juvenile Keyhole Limpets and, when fully-grown, each can produce an average of about 1 gram of KLH per year.

* Stellar is currently expanding its aquaculture farm of Keyhole Limpet’s to meet rising demand and aims to have more than 200,000 within the next few years.

* Several of the largest drug companies in the world are currently testing vaccines which utilize large quantities of KLH.
Stellar is also playing for a lot of chips in the global medical diagnostic market (where the KLH could be used in immune response tests) which is estimated at over $45 billion annually in the US alone. This company has the potential, if expansion continues, to not only make millions in annual revenue, but possibly much more in a few short years. All this coming from a company with a market cap under $10 million. The potential upside is blatantly obvious.

Wikipedia describes KLH as: a large, multisubunit, oxygen-carrying, metalloprotein found in the hemolymph of the giant keyhole limpet, Megathura crenulata which lives off the southern coast of California from Monterey Bay to Isla Asuncion off Baja California.

Key Fact & Game Changer: There are thought to be only roughly 120,000 Keyhole Limpets left in the wild and those numbers are quickly depleting. Now you can understand why a renewable source is so essential.

 

Keep in mind, Stellar has over 70,000 spawned and juvenile Keyhole Limpets at its aquaculture center – that’s the equivalent of 58% of the known wild supply in the entire world.

Daniel E. Morse, Ph.D. & Executive VP, Science & Technology for Stellar stated:

“My contributions to Stellar’s pioneering work with the keyhole limpet helped develop techniques for the precise control of reproduction and development in this valuable resource species, underpinning Stellar’s unique position as the only company world-wide to produce KLH from its own secure and renewable populations of aquaculture-raised animals, rather than from reliance on a dwindling supply of animals from the wild.”    

Stellar recognized the necessity of these rare species and developed a patented blood extraction technique that does not kill the animal (competitive techniques to Stellar’s kill the animal during the blood extraction process). This gives Stellar the ability to extract the extremely valuable KLH in the animals’ blood multiple times throughout its life. It is the only company known to be able to do this (patent protected) in the entire world.

 

How it works:

Stellar’s GMP (An FDA term for Good Manufacturing Practice)-grade KLH products are made exclusively from its colony of aquacultured Keyhole Limpets using the highest standards of biopharmaceutical processing and quality control.

The KLH protein is a flexible and proven carrier platform for the new and growing area of conjugate therapeutic vaccines in humans. It has also been used for decades throughout the world safely in humans as an immune stimulant. The molecule’s potent T-cell dependent antigen presentation properties are matched by compelling safety features, including a lack of toxicity and the absence of TSE (transmissible spongiform encephalopathy) risk.

Each domain of a KLH subunit contains two copper atoms that together bind a single oxygen molecule (O2). When oxygen is bound to hemocyanin, the molecule takes on a distinctive transparent, opalescent blue color. (For all of our mining enthusiasts out there, take notice: the blue is an expression of the copper! Our blood is red because it is iron-based). The KLH protein is potently immunogenic, yet safe in humans and is therefore highly prized as a vaccine carrier protein. The large and highly glycosylated (a $5 dollar word for “dotted with tiny sugar molecules”) KLH protein cannot be reproduced synthetically. It is available only as a purified biological product from the Keyhole Limpet.

Stellar Biotechnologies has the world’s only known secure, renewable source of this animal and its KLH protein. This fact alone could have a staggering impact on the company’s place in the biotech industry. When we learnt of exactly what the future could hold for Stellar and its shareholders, it wasn’t a question of ‘IF’ we would feature them and take them on as a client, but ‘WHEN’ – as timing is everything no matter where you invest.

Although Stellar had its IPO in April of 2010, it is light-years ahead of any recently IPO’d company we’ve ever researched, featured and taken on as a client. Stellar Biotechnologies began as a private, Port Hueneme-based California company in 1999.

The private company was founded by leading aquaculture CEO, Frank Oakes, formerly of The Abalone Farm, Inc. (the largest Abalone Farm in the world in North Central California), and eminent scientist, Daniel E. Morse, Ph.D. of UC – Santa Barbara, a Scientific American Top 50 Researcher.

Stellar’s technology platform was developed through $6 million in grants from the US National Institutes of Health (NIH), the National Cancer Institute (NCI) and the National Science Foundation (NSF). Stellar specializes in production of KLH (keyhole limpet hemocyanin) and has generated important intellectual property (IP) during its time as a private company.  This IP covers aquaculture technologies related to spawning and maintenance of the rare animal that produces this important biotech and pharmaceutical product. Stellar has also developed IP in bioengineering of specific formulations of this valuable protein.

In short, Stellar is breeding Keyhole Limpets to quadruple, octuple and even expand its current number by 50 times or more as it attempts to meet current demand and prepares for future exponential increases in demand.

 

Imagine this scenario:  If a mere 25,000 patients were taking a regime of a cancer vaccine utilizing the KLH protein it could result in the use of about a kilogram per year of KLH. 1000 grams (1 kilogram) of Medical Grade KLH would be needed to supply the patients and at, let’s say, $15,000 per gram, it equates to roughly $15 million dollars in revenues.

Imagine if 500,000 patients around the world began demanding KLH for various cancer vaccines. The money flowing into this field would be astonishing. If Pfizer or any of the world’s other largest pharmaceutical companies testing these products (which use KLH) are successful, a potential $150-$300 million industry could emerge – with the only known renewable source stemming directly from Stellar Biotechnologies.

Unlike many new IPOs, Stellar has had revenues since 2006 and its customers and co-research partners include multi-national pharmaceutical companies, world-renowned academic laboratories and research centers, as well as biotechnology companies and vaccine and diagnostic developers.

 

Why Stellar and Why Now?

Many of the largest pharmaceutical companies and top research centers in the world are developing vaccines which utilize KLH.

 

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If one of these companies, be it Pfizer, the largest pharmaceutical in the world by sales, or Novartis, the third largest in the world by sales, is to begin using KLH- based therapies, there is only one known renewable source for them to turn to: Stellar Biotechnologies (KLH:TSXV – SBOTF:U.S. OTC).

This fact alone presents an opportunity unlike any other investment we have featured. To have a vested interest in a company with the chance to have any one of the largest drug companies on earth decide to utilize its KLH, on any scale, is enough reason for us at Pinnacle to feature Stellar and proudly put our name behind them. Sure, there’s risk involved in any small cap company, including this one, but the risk to reward ratio for Stellar is precisely the opportunity we look for.

Stellar could gain a strangle hold on the KLH market and is recognised globally for its ability to supply consistent, medical grade, KLH used in cancer, hypertension, Alzheimers, lupus, arthritis and other vaccines which are under development. Remember, while medical grade KLH can sell for as little as $10,000 per gram, Stellar can command prices as high as $200,000 per gram for some final human dose formulations of KLH.

During our visit to Stellar’s headquarters in the summer, we asked if there was another company or competitor anywhere in the world with a supply of KLH. The answer was quite interesting.

Fortune 1000 company Sigma Aldrich (SIAL), is a supplier of various formulations of KLH, but, believe it or not, their raw material comes directly from Stellar.

There is another small German biotech/pharma company named Biosyn which has an office in Carlsbad, CA, but exports the blood from California limpets to Germany for purification. It seems they contract with local divers to catch limpets when they need them. This is not yet illegal, but without an aquaculture farm and proprietary technology to properly extract the KLH, where is their renewable source coming from? Remember, there are thought to be roughly 120,000 Keyhole Limpets left in the wild and those numbers are quickly depleting.

Pierce Chemical supplies a form of KLH to the “research market”. However, they do not currently have a GMP-grade product approved by FDA or USDA (Good Manufacturing Practice – meaning they have no KLH that could be injected into humans!).

The above-mentioned companies are Stellar’s known competitors. There is a reason Sigma Aldrich, a Fortune 1000 company, gets its raw material directly from Stellar! It’s safe to say that Stellar is a major controlling source in the chain of supply when it comes to KLH.

Stellar has, to our knowledge (and we’ve completed extensive research), the only scalable aquaculture facility to spawn these animals which produce KLH. It also has the only patented technique to extract the KLH without killing these animals. In addition, it is backed by the US government through significant grant funding to develop those technologies. The support by the US government was granted to ensure sustainable supplies of this key biomedical ingredient. If that isn’t enough, Stellar has an all-star management team of world-class calibre behind it.

Stellar boasts one of the most impressive and scientifically acclaimed management teams we have ever come across.

 

Frank Oakes – President & Chief Executive Officer

880ed623-6e7d-499a-9e16-763019a84b91A Co-Founder, and current CEO and President, Mr. Frank Oakes, has more than 30 years of management experience in aquaculture, including a decade as CEO of The Abalone Farm, Inc. It was there where he led that company through the R&D, capitalization and commercialization phases of development to become the first profitable and largest abalone producer in the world. Abalone is a fairly similar animal to the Keyhole Limpet.

Mr. Oakes is the inventor of the company’s patented method for non-lethal extraction of hemolymph from the keyhole limpet. He was the Principal Investigator on the company’s Phase I and II SBIR grants from the NIH’s Center for Research Resources, a California Technology Investment Partnership (CalTIP) grant from the Department of Commerce and is currently the PI (Principle Investigator) on the company’s SBIR grant from the National Science Foundation. He has consulted and lectured for the aquaculture industry around the world. Frank received his Bachelor of Science degree in Marine Biology from California State Polytechnic University – San Luis Obispo.

 

Daniel E. Morse, Ph.D. – Executive VP, Science & Technology

2ccf9a60-2b29-4c4f-94e6-068bb0104b72Dr. Morse is the Professor of Molecular Genetics and Biochemistry at University California Santa Barbara; he received his B.A. degree in Biochemistry from Harvard, and Ph. D. in Molecular Biology from Albert Einstein College of Medicine.

Dr. Morse was awarded a Career Development Award from the National Institutes of Health and a Faculty Research Award from the American Cancer Society; honored as a Distinguished Faculty Scholar by the Woods Hole Oceanographic Institution, and as a Visiting Lecturer in Japan and the University of Paris; elected a Regents Fellow of the Smithsonian Institution; and elected a Fellow of the American Association for the Advancement of Science.

Scientific American recently named Dr. Morse one of 50 leading technology pioneers of 2006 for his research on biologically inspired routes to nanostructured semiconductor thin films. He was honored as the 7th Kelly Lecturer in Materials and Chemistry by Cambridge.  Dr. Morse is Director of the U.S. Army-sponsored UCSB-MIT-Caltech Institute for Collaborative Biotechnologies.

 

Darrell Brookstein – Executive VP, Business Development & Finance

b9c5d065-973e-4f95-aac7-1159c3122553Mr. Brookstein is a well-connected serial entrepreneur and businessman in the financial and investment sectors. Every successful company has to have an individual who has demonstrated financial savvy and the ability to raise capital at the drop of a hat. Stellar has this in Darrell Brookstein. Since the early 1980s, Brookstein has been heavily involved in the Canadian public venture capital markets, and his name is closely tied to some of the most famous newsletter writers, financiers and resource company CEOs over the last 30 years.

Mr. Brookstein was the Managing Director of The Nanotech Company, LLC and a director of CAG Capital. He has founded, built to profitability and been CEO of investment firms involved in securities, commodities, mining and natural resource venture capital, as well as advanced technologies. Mr. Brookstein has published several books and newsletters related to business development and investing in these fields, including The Prospector and Nanotech Fortunes. He received his BA from Duke University.

It’s one thing to research a company via company materials, fact sheets, comparative analysis, scientific papers and hear all of the amazing things it can do and plans to do. It’s another thing to see its assets and daily functionality with your own eyes.

Less than 2 months ago, during our research process, we travelled down to Stellar’s aquaculture facility in Port Hueneme, California to see these Keyhole Limpets for ourselves. The facility is about an hour drive from LAX airport, situated right on the beautiful Southern California Coast. Stellar shares its sea access with the US Navy’s Construction Battalion Center which owns 1600 acres on the Port.

Before arriving, we had to send in our passports weeks in advance to gain clearance to the facility as security was extremely tight.

Once we arrived, we quickly learned that Mr. Oakes, Stellar’s CEO, was an extremely gracious and friendly man who had an uncanny ability to explain things in layman’s terms.

He took us right outside to the massive container tanks (see below) to show us the Keyhole Limpets which he is extremely passionate about. He was holding one in his hand as he explained his proprietary extraction technology.

 

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We saw thousands of Keyhole Limpets, some as large as a man’s hand, others so small we had to view them through microscopes. There were many different sized containers for different sized Keyhole Limpets. All of the sea water was freshly pumped in and out of the facility, continuously circulated through the containers 24 hours a day. We were never more than a few hundred feet from the ocean and it was obvious that the filtration system had been mastered. The facility was astonishingly clean and organized. Everything was recorded and there were countless expansion plans within the facility which Mr. Oakes outlined throughout the tour. There is no doubt in our minds that Stellar has the ability to expand its reach and prominence within the KLH market.

Of equal importance as visiting the facility ‘where the magic happens’, was sitting down with Mr. Oakes and his staff. When you research dozens of companies a year, it’s fairly easy to spot the people who truly believe in what they do and likewise, those who do not. Mr. Oakes is extremely passionate about Stellar both as a company and as an investment.  He truly believes he is changing the dynamics of the biotech space in which Stellar operates. You can see it in his body language when he explains what Stellar has achieved to date, or in the confident smile across his face when discussing expansion plans and what markets he wants to tap in to.

As major drug companies around the world continue to test drugs and vaccines which utilize KLH, Stellar’s story could quickly gain significant market popularity.  We wanted to be the first to introduce you to this one of a kind investment opportunity and our new Featured Company. Consider our team extremely biased when it comes to Stellar as the company is a client of ours and we have invested in  its recent private placement and will be purchasing more shares of Stellar this week, making it one of our largest holdings. It is our belief that we can’t feature a company, and put our name behind it, if we aren’t shareholders ourselves.

Please feel free to contact us if you have any questions. In addition, you can scroll down to view images from our site visit to Stellar’s aquaculture farm.

All the best with your investments,

 

PINNACLEDIGEST.COM
Key market stats for Stellar Biotechnologies (KLH:TSXV)(SBOTF:US OTC)

IPO Price: $0.28

Current Price: $0.32

Shares Outstanding: 28.3 million

Average Volume: 56,000 shares per day

Market Cap: $9.8 million

 

VISIT STELLAR BIOTECHNOLOGIES ONLINE

READ STELLAR’S ONLINE CORPORATE BROCHURE

IMAGES OF OUR SITE VISIT TO STELLAR’S HEADQUARTERS

Arriving at Hueneme Aquacultural Park – Home to Stellar Biotechnologies
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Going through security to gain access to Stellar’s Aquaculture Center

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CEO Frank Oakes takes us on a walk through of the mature Keyhole Limpets habitat owned by Stellar

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Frank Oakes explains the importance of maintaining the limpets habitat for optimal results

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Mature Keyhole Limpet – shell side up (notice the hole at the top of the shell)

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Mature Keyhole Limpet – interior

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Brandon Lincicum, M.S., Stellar’s Aquaculture Manager, educates Pinnacle Digest’s Alexander Smith, on the required living conditions for baby and juvenile Keyhole Limpets.

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In the building specifically to house recirculating tanks used to hold Limpets prior to non-lethal bleeding.

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Recirculating tanks filtration system

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Disclosure, Risks Involved and Information on Forward Looking Statements: please read carefully before proceeding.

Important: Our disclosure for this report on Stellar Biotechnologies applies to the date this report was released to our subscribers (September 8, 2010) and posted on our website. Our disclosure within this report may never be updated, even after we have sold all of our shares in Stellar Biotechnologies.

PinnacleDigest.com is an online financial newsletter owned by Maximus Strategic Consulting Inc.. We are focused on researching and marketing for small-cap public companies. Nothing in this report should be construed as a solicitation to buy or sell any securities mentioned anywhere in this report. Nothing in this report should be construed as a solicitation to buy or sell shares of Stellar Biotechnologies. The author of this report bears no liability for losses and/or damages arising from the use of this report.

Forward-looking statements: This report contains certain “forward-looking” statements and information relating to Stellar Biotechnologies that are based on the beliefs of the Company’s management as well as assumptions made by and information currently available to the Company’s management. Such statements reflect the current risks, uncertainties and assumptions related to certain factors including, without limitations, competitive factors, general economic conditions, customer relations, relationships with vendors and strategic partners, the interest rate environment, governmental regulation and supervision, seasonality, technological change, changes in industry practices, and one-time events. Should any one or more of these risks or uncertainties materialize, or should any underlying assumptions prove incorrect, actual results may vary materially from those described in this report and in the company’s news releases.

Forward-looking statements are often, but not always identified by the use of words such as “seek”, “anticipate”, “plan”, “continue”, “estimate”, “expect”, “may”, “will”, “project”, “predict”, “potential”, “targeting”, “intend”, “could”, “might”, “should”, “believe”, “budget”, “scheduled”, and similar expressions.

Much of this report on Stellar Biotechnologies is comprised of statements of projection. These statements involve known and unknown risks, uncertainties and other factors that may cause actual results or events to differ materially from those anticipated in such forward-looking statements.

Risks and uncertainties respecting publicly traded companies are generally disclosed in the annual financial or other filing documents of those and similar companies as filed with the relevant securities commissions, and should be reviewed by any reader of this report. In addition, with respect to any particular company, a number of risks relate to any statement of projection or forward statement.


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Most companies featured in our newsletter and on our website are paying clients of ours (including Stellar Biotechnologies – details in this disclaimer) and in many cases we own shares in the companies we feature. For those reasons, please be aware that we are extremely biased in regards to the companies we write about and feature in our newsletter and on our website. Any decision to purchase or sell as a result of the opinions expressed in this report OR ON PinnacleDigest.com will be the full responsibility of the person authorizing such transaction.

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PinnacleDigest.com is not responsible for any claims made by any of the mentioned companies. You should independently investigate and fully understand all risks before investing. We want to remind you again that PinnacleDigest.com is often paid editorial fees for its writing and the dissemination of material and the companies featured do not have to meet any specific financial criteria. The clients represented by PinnacleDigest.com are typically development-stage companies that pose a much higher risk to investors (Stellar Biotechnologies is a development stage company and is extremely risky to invest in). When investing in speculative stocks of this nature, it is possible to lose your entire investment over time.

Set forth below is our disclosure of compensation received from Stellar Biotechnologies and details of our stock ownership in the company as of September 8, 2010:

Maximus Strategic Consulting Inc., owner of PinnacleDigest.com, has been paid CDN$40,000 plus gst to provide online advertisement coverage for Stellar Biotechnologies, Inc. The company (Stellar Biotechnologies, Inc.) has paid for this online advertisement coverage. The coverage includes, but is not limited to, the creation and distribution of reports authored by PinnacleDigest.com about Stellar Biotechnologies, Inc. (reports such as this one). Maximus Strategic Consulting Inc., owner of PinnacleDigest.com, subscribed to Stellar Biotechnologies’ recently announced Private Placement. In that private placement Maximus Strategic Consulting Inc. purchased 70,000 units (the “Units”) at a price of $0.28 per unit in Stellar Biotechnologies. Each Unit is comprised of one common share and one non-transferrable share purchase warrant (a “Warrant”) at $0.40. The units we (Maximus Strategic Consulting Inc.) purchased in Stellar Biotechnologies’ private placement are now free trading and we intend to sell every share we have purchased for our own profit.  We (Maximus Strategic Consulting Inc. and its employees and consultants) intend to sell every share we have purchased, and may purchase in the future, of Stellar Biotechnologies for our own profit. We may sell all of our shares without notice to our subscribers. We may purchase more shares in Stellar Biotechnologies without notice to our subscribers. Please remember, we currently own shares in Stellar Biotechnologies. Recognize that we are extremely biased when it comes to Stellar Biotechnologies.

To get an up to date account on any changes to our disclosure for Stellar Biotechnologies (which will change over time) view our full disclosure at the url listed here (may have to copy and paste url into browser bar):  https://www.pinnacledigest.com/privacy-policy-terms-use-our-disclosure

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