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May 10, 2007 @ 1:30 PM
Complete Response (or "approvable") letter is very disappointing and a surprise. Resolute to bring Provenge to patients.
CMC (manufacturing) information requested can be easily provided to FDA.
Clinical data request was for additional efficacy data. They did not specify what data they want; we are seeking clarification. But our Impact study is double blind, randomized, placebo-controlled Phase III trial and has an SPA (special protocol assessment). It measures overall survival in men with metastatic hormone-refractory prostate cancers. The SPA is a binding written agreement that provides for official FDA evaluation on pivotal trials that will form the basis of final approval. Our SPA recognizes that he Impact study will serve as a registration study based on positive results from either an interim or final analysis. Believes well positioned to complete an interim analysis next year with a final analysis available in 2010.
Therefore believes the Impact study will provide the FDA with the necessary additional data to complete the approval process.
Q1 Results
$80,000 revenue.
$32 million in operating expenses, driven by one-time $6.3 million payment for commercial quantities of antigen.
$88.5 million cash and equivalents at end of quarter. Cash used was $30.3 million.
Believes cash balance is sufficient to take company through preliminary results on Provenge in 2008.
$30.9 million or $0.38 per share net loss.
Q&A
How did discussions change between panel meeting and final decision? We were surprised there was very little discussion with them.
Discussions since letter? Impact study is binding, looking at survival both on interim and survival data.
Trial designed that positive data from study would be sufficient at interim; uses more death events than two prior studies combined.
Gleason score and location of mets? Randomization issues, both which arms patients go into and regression studies of data. New trial methodology has been approved by FDA.
Cash burn? Taking short term actions to preserve cash. Plan not final yet. Does not comment on potential partners.
Timeline going forward? Appears FDA wants to work closely with company to bring Provenge forward as rapidly possible.
Appeal to letter? Option is available, but is not considering that right now.
Expenses of trial due to crossovers? Most of the cost is in the first month, but crossovers (further injections) cost more.
Cash sufficiency? Trial interim leg could take down to very low levels; should that happen will pursue further financing.
Shelf life of antigen? Lasts years.
Isn't failure of interim likely? No, trial really began in 2003, data is likely to be positive. Continuing to enroll patients now. On average it is 18 to 20 months before patients die. Event-driven analysis, so it still takes time to reach an interim analysis.
Manufacturing issues? Chemistry manufacturing control inspection February 12th resulted in observations we are already addressing. Needs to complete response; we know the issues; they are well in hand. FDA says it is the clinical data that is the hold up.
Safety concerns? No, it is all about additional efficacy data.
Crossover design? Like 9901 and 9902a studies. Once they progress they can receive a salvage (frozen, not as potent) version of product. Is designed into new study.
New (Impact) study has similar demographics to previous study. No problem with symptomatic versus antisymptomatic.
Does letter ask for anything non-manufacturing besides efficacy data? No.
Shelf registration? It is effective. Timing to raise funds is uncertain, but will be accessing the market before the interim is submitted. May raise cash through other means.
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Disclaimer: Our analyst summaries may include both our condensations of statements made by company representatives and our own analysis. They are not covered by any warranty. We cannot guarantee anything said by company representatives is true. We try not to make errors, but it is possible. Before making or terminating an investment you should always verify any factual basis of your decision.
Copyright 2007 William P. Meyers