Text in italics represents our comments, not management's.
conference date: November 8, 2006
for quarter ending: September 30, 2006 (2nd quarter)
Overview: Continues to spend heavily while waiting to see if Provenge is approved. Supportive results continue to come in.
Revenues $84,000. Operating expenses $21.7 million, including 1.2 million in stock-based compensation. Net Loss of $20.7 million or .29 per share.
Ended with $92.6 million cash and equivalents, about 4 quarters worth at current burn rate.
Reminded that they have submitted parts (clinical and non-clinical portions) of their BLA (Biologics License Application) to the FDA to seek approval of Provenge (sipuleucel-T) for prostate cancer (specifically, asymptomatic, metastatic, androgen-independent, or hormone-refractory, prostate cancer). They also released further statistical analysis of clinical trials showing that Provenge is effective at increasing the percentage of survivors. Manufacturing portion of BLA is also on track for submission.
Preliminary results from the Protect (P11) study were also announced. This study was designed to test Provenge on patients who have had recurring but non-metastatic prostate cancer (non-metastatic androgen-dependent (hormone sensitive) prostate cancer). Patients showed an increase in PSA (prostate specific antigen) doubling time, which is taken as a predictor of outcomes. The study of 176 patients showed a 35% increase in doubling time compared to those taking placebos. There was a delay of 27% to distant metastasis, but only a fraction of patients have reached that endpoint, so statistical significance has not yet been established. All patients will be followed for failure and overall survival. A study of the immune response itself showed, with statistical significance, that immunity to PA2024 continued in Provenge patients persisted long after dosing. The product also appeared to be safe, with no unexpected side-effects. This would indicate that Provenge can be useful to patients before their cancers metastasize. However, P11 is not designed to be a registration (for approval) study. Other studies will be necessary for that.
Impact trial (9902B) enrollment is strong and should be completed by end of year.
Confident will be approved and will be first-to-market with this type of therapy.
9902B is designed to enroll 500 patients with primary endpoint of survival.
P11 use in BLA? FDA does not accept biochemical data for label expansion, so for now will be used to support safety data. Belief now current in field that PSA doubling time is a good predictor.
Cash? Have enough cash to get through BLA and FDA decision point. Will have to raise cash to get through manufacturing and commercialization.
Satraplatin? Seeing a number of products showing activity for prostate cancer. Doctors like to use less toxic therapies first. Provenge will be front-line therapy. Immune response appears to be durable, so you could put other therapies after Provenge.
P11 balance between 2 arms? Data looks balanced (between placebo and treated patients), but this is early data.
Plans if billion dollar plant capacity exceeded? As demand ramps up if they need to add more capacity elsewhere, they will.
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Copyright 2006 William P. Meyers