I have been following Poniard Pharmaceuticals for a few years; this company appears to be at a turning point. The webcast last Monday was interesting; it’s clear that the company is at a crossroads.

Like many biotech companies in the Bay Area, Poniard has had a storied history; you might remember the company as NeoRX.  The company has been around longer than many of its peers: it’s over twenty years old—ancient by biotech standards and a little sad too.  Companies that old have either succeeded wildly or been absorbed into a larger, more successful entity; most have died.  A few, like Poniard, linger on hoping for that great break in the clinic.

Platinum has had a long history as an agent to fight cancer.  Picoplatin is an organic complex of this metal designed to act as a chemotherapeutic agent against cancer, particularly in solid tumors where platinum resistance is observed.  Most recently, Poniard used the material in an unsuccessful trial to fight small cell lung cancer: the company failed to meet the endpoint.  Management has expressed the likely legitimate concern that the way cancer is treated in Europe versus the US essentially messed up the results.  The company believes that treatment with the drug showed a trend towards a survival advantage; the post treatment chemotherapy in Europe favored patients that received the standard or care, the control group, over those on Picoplatin.  Incidentally, Pharmacyclics had a similar issue after its failed phase III trial.  For the case of Pharmacyclics, the company claimed that analyzing a subset of data clearly demonstrated the efficacy of the drug in the phase III trial.  The FDA doesn’t permit this sort of retrospective analysis.  Poniard is caught in a similar trap—at least that’s the sense of the argument provided by management.  The company has one more last shot: a phase III trial on colorectal cancer—quite a big market.

Poniard presented results for its phase II colorectal cancer trial this summer; the data were pretty impressive.  The company is now working with the FDA towards staging the required Phase III trials, which, if successful, would help secure approval for the drug.

The company is short of cash, but it has had some moderate good news in the past few months.  Just over $6 million were raised through the sale of shares of common stock to a value fund.  The company received a composition of matter patent, which covers the use of picoplatin in any cancer.  The patent covers the drug through early 2016 and the potential exists for an additional five year extension under the Waxman Hatch Act.  The company is also seeking marketing partners for picoplatin.

While the clinical results are ambiguous, the drug is certainly not dead.  A better designed protocol may help address concerns about picoplatin for small cell lung cancer; the upcoming phase III trial for colorectal cancer is critical.  Licensing the drug for a specific therapy could be a way to generate the cash this company needs to survive.

Poniard is a high risk investment—maybe one should wait for another clinical result before investigating this company further.  If the company manages to secure a partnership, with some of the risk mitigated, PARD would be in inviting investment opportunity.