Cell Therapeutics (CTIC) is a micro-cap cancer biotech which is down substantially in the past year in terms of stock price and market value, but not out after recently establishing a joint venture with Spectrum Pharma (SPPI) to market Zevalin, the potential for two FDA approvals this year (one new product, one label expansion), the potential for EMEA approval of Opaxio in the E.U., and a goal to become cash flow break-even by year-end.
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World Health Organization report released late last year estimates that cancer will overtake heart disease as the top cause of death in the world by 2010, which is part of an overall trend that predicts global cancer cases and deaths will more than double by 2030. The report predicts 27 million new cases of cancer will occur in 2030, which is a sharp increase from the 12 million cases of cancer in 2007.
Near-term events for CTIC include a
special meeting for shareholders scheduled for 2/6/09 to obtain approval to increase the number of authorized shares of common stock (from 400M to 800M), conduct a reverse split (between 1:2-1:20), and increase the number of shares authorized for equity incentive + employee stock purchase plans – with the first two proposals aimed at regaining compliance for continued listing on the Nasdaq Capital Market by a deadline of 2/12/09. CTIC will also be presenting at the 11th Annual BIO CEO & Investor Conference on Tuesday, February 10th at 9:30 AM in the Jade Room of the Waldorf-Astoria Hotel in New York City –
click here for a link to the webcast for this event.
CTIC and SPPI have an upcoming PDUFA decision date (
one of 14 extreme FDA trades, including companies with market caps below $100M with pending regulatory decisions) of 4/2/09 with a priority review designation for their sBLA to expand the label of Zevalin (Ibritumomab Tiuxetan) as consolidation therapy after remission induction in previously untreated patients with follicular non-Hodgkin's lymphoma (NHL). Zevalin is currently approved for the treatment of relapsed or refractory low-grade or follicular B-cell NHL, which is now being marketed by the 50/50 joint venture between CTIC and SPPI called RIT Oncology.
CTIC received $15M in cash along with a 50% interest as part of the agreement with SPPI to form the joint venture to further develop and market Zevalin.
