The End Is Near for Cell Therapeutics

Monday's FDA setback for its cancer drug has ignited a fiscal crisis at Cell Therapeutics which could lead to the company's demise.
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) --How much trouble does

Cell Therapeutics

(CTIC) - Get Report

find itself in? Even Rodman & Renshaw downgraded the stock this week.

Rodman is the healthcare investment banker of last resort, the go-to financier for the bottom of biotech's barrel. And yes, Rodman has raised money for Cell Therapeutics in the past, most recently in January. So when Rodman's biotech analyst gives up on Cell Therapeutics, you can be darn sure the future of the company is in very dire straits.

Monday's decision by a U.S. Food and Drug Administration advisory panel to

recommend unanimously against approval of Cell Therapeutics' lymphoma drug pixantrone

has ignited a serious fiscal crisis at the company.

Cell Therapeutics' shares are hanging stubbornly around the 70 cents level, remarkable given the gravity of the company's situation. That's not likely to last long, however. At this point, Cell Therapeutics isn't worth any more than 10 cents a share, and that's being generous with valuation.

The FDA is expected to announce its approval decision for pixantrone on April 23. The drug has essentially zero chance of being approved at this time, given the FDA's vociferous criticism of the pixantrone clinical data in non-Hodgkin's lymphoma (NHL) coupled with the 9-0 negative vote by the advisory panel.

Cell Therapeutics needed to raise more money with or without pixantrone's approval. The latter scenario makes the job all that much tougher. Bankruptcy is a real possibility if Cell Therapeutics doesn't find a way to raise more cash and pay down its debt. Even if the company manages to complete a financing, pixantrone's commercial potential is forever stunted, if not altogether dead.

At the end of February, Cell Therapeutics reported a cash position of $51 million. The company is burning approximately $7-8 million per month, which means the current cash on hand runs out in August.

Cell Therapeutics' cash crunch is exacerbated by the $40 million in convertible debt that the company must figure out a way to repay before July 1.

All in, Cell Therapeutics needs to raise about $70 million just to remain in business through the end of the year. At the current stock price of around 70 cents, this would require Cell Therapeutics to sell 100 million shares of common stock, bringing the company's total share count to almost 720 million.

Cell Therapeutics' CEO Jim Bianco is a wily biotech veteran, so maybe he can figure out a way to keep the company's lights on through Christmas. But what happens next?

Bianco will have to raise even more money to bring pixantrone back from the dead.For Cell Therapeutics to get pixantrone approved, at least one new clinical study will be required, most likely testing the drug in combination with an existing drug(s).

That was the suggestion made both by some of the experts on the FDA's panel and the agency reviewers.

Let's assume that this pixantrone combination drug study can begin next year and takes three years to complete. Let's also assume the study is positive. Under this rosy scenario, pixantrone could be approved and ready to hit the market in 2014-2015.

Will there be a commercial market for pixantrone in 2014-2015? Not much of one. Cell Therapeutics doesn't disclose specifics about pixantrone's patents, but a

Wikipedia listing

for the drug mentions U.S. patents filed in 1995. If that's accurate, pixantrone would have very little or no patent protection at its commercial launch other than the normal and relatively short-lived patent extensions granted to new drugs upon approval.

Cell Therapeutics did not respond to an email requesting more information about pixantrone's patent estate.

Even if Cell Therapeutics could manage to launch a branded pixantrone in 2014-2015 with a premium price tag, doctors who treat NHL patients would have access by that time to generic versions of Doxil, or doxorubicin, the anthracycline used most commonly to treat lymphoma patients.

Pixantrone and Doxil both belong to the anthracycline class of cancer drugs.

The only way a branded pixantrone could gain traction over a cheap generic doxorubicin would be if the former were less cardio-toxic. Based on the pixantrone clinical data presented Monday, that scenario isn't likely.

Die-hard supporters of Cell Therapeutics might be clinging to the prospect that


(NVS) - Get Report

could still swoop in to partner pixantrone or even buy out the company entirely. The dicey patent life of pixantrone and the long runway to any approval essentially kills that outcome.

The FDA did tell Cell Therapeutics Monday that it could allow sick-and-dying lymphoma patients access to pixantrone prior to the drug's approval. Unfortunately, the best Cell Therapeutics can do financially under a so-called expanded access drug program is to recoup operating costs related to pixantrone. FDA will not allow Cell Therapeutics to generate any profits on pixantrone until the drug is formally approved.

Cell Therapeutics' outlook doesn't improve much if the company decides to ditch pixantrone entirely. Its only late-stage candidate is the cancer drug Opaxio. But remember, Opaxio is just the

new brand name for Xyotax

, a reformulation of the chemotherapy drug paclitaxel that failed to meet primary endpoints in a series of phase III lung cancer studies in 2005.

European regulators rejected the drug's marketing application last year. Cell Therapeutics is now pinning Opaxio's hopes on an ovarian cancer study that is taking forever to enroll patients. Cell Therapeutics tried to convince the independent group running the ovarian study to conduct an interim analysis of the data this year, but the group refused, choosing instead to stick with a plan that won't yield data until 2011 or perhaps even 2012.

Even if the Opaxio data are positive, it's not entirely clear if Cell Therapeutics can use the study as the basis for an approval filing with the FDA. Opaxio is not much to build around a future for Cell Therapeutics.

After Opaxio, Cell Therapeutics has brostaciclin, but this cancer drug is still in early-stage studies.

Cell Therapeutics has burnt through $1.4 billion in cash since 1991, with little to show for it, yet the company has managed to stay afloat. Monday's pixantrone setback is serious and may finally put Cell Therapeutics out of business for good.

-- Reported by Adam Feuerstein in Boston.

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Adam Feuerstein writes regularly for In keeping with TSC's editorial policy, he doesn't own or short individual stocks, although he owns stock in He also doesn't invest in hedge funds or other private investment partnerships. Feuerstein appreciates your feedback;

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