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Business Strategy
CEL-SCI's vision is to change the way cancer is treated. We develop novel immune-based therapies that harness the body's own immune defense system to fight disease. These therapies are effective and non-toxic to the body's normal cells and organ systems, unlike traditional cancer therapies such as chemotherapy, radiation and surgery, which are most often highly toxic or damaging.
Multikine®, our flagship cancer immunotherapy product, is directed at unleashing and empowering the body's own anti-tumor immune response. Multikine® is being developed as a First-Line therapy for cancer, meaning it will be used before a patient receives any therapy for their cancer.
The goal is to help make a patient's first treatment more successful. Should Multikine® perform as intended, it is likely that it will be administered to most cancer patients before they begin their first course of traditional therapy. This would make Multikine® a widely used and trusted agent within a large patient population.
We have three core beliefs with respect to building CEL-SCI into a successful biotech company:
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Our immune system continuously fights off cancer. As we age, our immune system weakens, making us more likely to develop cancer with each passing year. That is why cancer generally occurs more frequently in older people. We believe that we can enhance a weakened immune system to fight cancer. |
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We believe in creating genuinely new, valuable and unique therapies that meet unmet medical needs, as opposed to minor innovations to existing therapies or 'me-too' products. |
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We believe in holding on to the key marketing rights for our products and technologies. |
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History shows that the most successful biotech companies held on to at least some of their key marketing rights. Our plan is to do the same and to diversify risk by leveraging our technology and products into other indications, such as breast and skin cancer, rather than by bringing in licensing partners for all of the marketing rights. We do, however, expect to partner our technologies in some parts of the world.
The top four reasons smaller biotech companies partner with larger pharmaceutical counterparts are:
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Sales force - Most small biotechs need the distribution power of the larger companies' sales forces. |
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Manufacturing - Most small biotechs do not have the resources to build the complex and costly manufacturing facilities required for biologics. |
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Lack of funds - Most small biotechs need funding to sustain their activities throughout the lengthy clinical trials process leading up to drug approval. |
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Credibility - Larger pharmaceutical companies can contribute additional credibility to validate an emerging biotech technology. |
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At CEL-SCI, we have structured ourselves to address these challenges so that we can remain independent and create the greatest value for our shareholders.
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Sales force: If approved, our flagship cancer product, Multikine®, will be included in standard-of-care therapy for head and neck cancer. Standard-of-care therapy refers to therapy that a patient would routinely receive because it constitutes the best available treatment. This means that the great majority of newly diagnosed head and neck cancer patients would receive Multikine® prior to any other cancer therapy. Standard-of-care will translate into nearly automatic use of the product, and thus negate the need for a major sales force. In addition, the number of physicians who are responsible for these patients is small - another reason we have no need for a large sales force. |
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Manufacturing: Our manufacturing process is very specialized. We have not found a manufacturing facility at any pharmaceutical company that can be used to manufacture our product. In 2007 we announced that we have commenced building our own dedicated manufacturing facility for Multikine®. |
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Lack of funds - With our solid science and upcoming Phase III trial, we are creating the necessary excitement for Multikine® that will translate into significant funding from diverse investors. We spend resources only on those things that are necessary to advance our products and to create shareholder value. Historically, we have shown the determination and ability to weather the erratic and unpredictable biotech investment arena, and we have managed to move forward on the strength of our scientific promise. For these reasons, we do not anticipate overwhelming challenges in our future financial outlook. |
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Credibility - The desire to gain credibility in the eyes of others is not reason enough to give away control and thereby lose a very large part of the upside. |
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By retaining our key marketing rights for our products and technologies, we have retained the greatest upside for our investors. The difference in market capitalization between a cancer company that retained key marketing rights to its key drug (e.g., Celgene, CELG, NASDAQ) and one that licensed out its key drug completely (e.g., Imclone, IMCL, NASDAQ) is astounding. Before Imclone was purchased by Eli Lilly, both had a similar level of sales and both were growing well. Yet Celgene's market capitalization was 6 - 7 times higher than that of Imclone. The difference derived from the high percentage of sales and profit (somewhere around 70 to 90%) that the pharma partners have taken for selling the drug. Our goal is to build an immunology company that will be a life saver to patients and a homerun similar to Celgene for investors.
Furthermore, the end of the long Multikine® development program for CEL-SCI is near! Multikine® is in the final stages of clinical trials and has already been cleared by the regulators for a global Phase III trial. It has received a go-ahead by the US FDA as well as Canadian regulators. The pivotal Phase III study will enroll about 800 patients in an open-label, multinational, global clinical study. With these important milestones having been reached, or being well within our grasp, we are moving forward rapidly with a real sense of purpose and excitement. We believe strongly that our time has come!
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