See feature article below: Stellar Biotechnologies, Inc. (NASDAQ: SBOT)
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Report For: Stellar Biotechnologies, Inc. (NASDAQ: SBOT)
Stellar Biotechnologies, Inc., a biotechnology company, engages in the aquaculture, research and development, manufacture, and commercialization of keyhole limpet hemocyanin (KLH) protein primarily in Europe, the United States, and Asia. KLH is an immune-stimulating molecule used as an active pharmaceutical ingredient in various new immunotherapies; and as an injectable product to assess immune response. SBOT shares are up 19% at $3.89 with trading volume over four times the daily average.
Interview of Maxim Groups Jason McCarthy by Streetwise’s Tracy Salcedo
Jason McCarthy: Given the current bear market—the correction we’ve seen over the last six months in the biotech markets—we believe the stock is artificially depressed, like most of biotech right now. The stock was closer to $7–8/share not long ago.
The value proposition revolves around what Stellar’s partners are doing. The company has key partnerships, including one with Neovacs SA (ALNEV:Alternext Paris), a French company working on systemic lupus. It also has a partner in OBI Pharma Inc. (4174:Taipei) in China, which is working in breast cancer. OBI recently presented promising data from a Phase 2b study demonstrating statistically significant improvements in progression-free survival and overall survival in women that generated immune responses from OBI’s keyhole limpet hemocyanin (KLH)-based vaccine. A Phase 3 study is now being planned. In addition, Stellar has undisclosed partners working in Alzheimer’s disease, as well as other undisclosed oncology and autoimmune indications.
“Stellar’s KLH is a part of what could be blockbuster vaccines.”
What drives biotech is data: data showing definitive proof of concept, data from a Phase 3 study that moves a therapy closer to a biologic license application, a new drug application filing or drug approval. When you see these successes from biotech companies, you often see valuation inflection.
Though Stellar is not specifically making vaccines, its KLH is a part of what could be blockbuster vaccines that are currently in proof-of-concept studies. If one of these vaccines is successful, that’s a reflection on Stellar. We believe the company stands to be the beneficiary of a successful vaccine from the point of view of KLH supply. Its valuation should flow hand-in-hand with the successes of its partners.
TLSR: Can you discuss some of the programs that Stellar is working on in conjunction with its partner companies?
JM: OBI is doing work in metastatic breast cancer. The whole idea of KLH is that it drives what I believe are antibody-biased responses. With KHL-based vaccines, you can also see significant T-cell responses. What OBI found in breast cancer patients with metastatic disease is that some patients developed significant antibody titers targeting globo H, which is the antigen it made the KLH vaccine with. There was a statistically significant improvement in progression-free survival, as well as overall survival.
This testing took place in China, and there are still a lot of things that have to happen in the U.S. and in Europe before investors really take note. I think people didn’t pay attention to this data, but to us it was a significant result. It is suggestive that a KLH-based immunotherapy could work in breast cancer, and we’re curious to see where OBI Pharma takes this. The benefit to Stellar is that it is going to keep supplying OBI’s KLH.
TLSR: What sets Stellar’s KLH apart from the competition?
JM: Stellar’s KLH is the only quality KLH that meets the standards for general manufacturing practices (GMP) grade. You can get lot-to-lot consistency such that you can actually make a vaccine that regulators could find suitable for approval. That’s the difference. If one of Stellar’s partner companies is successful, it would likely have to continue to use Stellar’s KLH. It has to use the same product it used to get through its clinical studies.
The competition, to our knowledge, can’t develop such a consistent KLH product. Stellar is the only company that has on-land aquaculture that houses and grows keyhole limpets, which is actually an animal. Thus, Stellar has a very defined population of keyohole limpets. The company is controlling the water environment, the nutrients the limpets are receiving. It is harvesting with very specific protocols, only at certain times a year, only a certain amount of KLH per animal.
“With KHL-based vaccines, you can also see significant T-cell responses.”
Other KLH manufacturers have to go to the Channel Islands in California, which is the only place keyhole limpets grow, to harvest the animals off the bottom of the ocean. Most people would say there’s inconsistency there. Even though the manufacturing process may be on par with what Stellar is doing, these companies have no idea what’s really happening in the ocean on a day-to-day basis. That’s the major difference between Stellar and any competitors in the KLH space.
TLSR: Does Stellar have an advantage in terms of cost because it is raising these animals in a facility as opposed to having to go out to the Channel Islands to harvest them?
JM: Stellar has a cost advantage in that, since the company raises the animals, it can manufacture in bulk. Having the manufacturing capability to meet kilograms and kilograms of demand (KLH protein) mitigates some costs associated with the aquaculture facility. . .supply and demand.
Overall, I think Stellar’s net margin is reasonable. We project the company’s cost of goods to be only about 35%, which a 65% margin—not as great as pharmaceutical margins at 80–90%, but better than where a biologic would be, like a checkpoint antibody or a chimeric antigen receptor (CAR) T-cell. We think Stellar has a viable commercial business.
Source – Streetwise / Tracy Salcedo
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