CEL-SCI Research Update Released
Published: May 20, 2013
New York, NY - On May 17, 2013, Taglich Brothers released an updated research report on CEL-SCI Corporation (CVM) and reiterated a Speculative Buy rating with a 12-month price target of $0.70. The report noted the following key investment considerations:
• When Multikine clears regulatory review, it could, by our estimates, grow into a $700 million product by 2020. Multikine is a unique cancer immunotherapy that aims to significantly improve survival rates in advanced head and neck cancer cases. • There are approximately 90,000 new cases of head and neck cancer diagnosed yearly in the US and Western Europe, of which an estimated 60,000 would qualify for Mulltikine immunotherapy.
• Multikine US orphan drug status and a significant unmet need in advanced head and neck cancer patients underlie the potential for more rapid regulatory review and stronger pricing flexibility when the product is launched.
• Phase II trial results demonstrated significant cancer tumor reduction in a small group of patients treated with Multikine. A large scale phase III trial now underway in the US and a number of overseas centers is being expanded by 60 to 80 sites under the management of new contract research organizations. As of April 13, 2013 the phase III trial had enrolled 177 subjects at 39 centers in eight countries.
• R&D will weigh heavily on costs through FY14 as the Multikine study expands. We project losses of ($0.04) and ($0.06) per share in FY13 and FY14, respectively.
• Near-term financing needs will be substantial. The Multikine phase III study will cost the company an estimated $37 million, of which only $7 million had been paid as of March 31, 2013.
The full report can be viewed at http://www.taglichbrothers.com/equityuniverse/companies/celsci/celsci.aspx.
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CEL-SCI Corporation (NYSE: CVM), headquartered in Vienna, Virginia, is a development stage biopharmaceutical company focused on unique immunotherapies that address unmet needs in significant patient populations.
In recent years, the company’s R&D has centered on immunotherapy for head and neck cancer, which now absorbs practically all of its R&D spending. Product development includes work on LEAPS (Ligand Epitope Antigen Presentation System) technology treatments for a range of influenzas and a vaccine against rheumatoid arthritis.
The company’s lead drug candidate, Multikine®, is a synthesized combination, non-specific immunotherapy currently being evaluated in a phase III study as neoadjuvant therapy for advanced primary (untreated) head and neck cancer.
Multikine is under study in a 48-center, 800+ subject phase III clinical trial that aims to demonstrate that it can, in combination with follow-on surgery, radiation and chemotherapy, reduce mortality in advanced head and neck cancer cases by 10%. The therapy aims to reduce mortality by eradicating micro-metastases, microscopic tumors that survive the therapy, are difficult to detect, and are arguably the underlying cause of disease recurrence.
Multikine has orphan drug status in the US.
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