Conference date: August 12, 2008 @ 1:30 PM Pacific Time
for quarter ending: June 30, 2008 (2nd quarter)
Overview: This amounts to a report on quarterly expenses, since the real question is whether Provenge data due in October will be positive.
Basic data (GAAP):
Revenue was $26,000, down from $31,000 in Q1 and from $0.5 million year-earlier.
Net loss was $16.5 million, less than the loss of $19.5 million in Q1 and also less than the loss of $22.2 million year-earlier.
EPS was negative $0.18 per share.
Operating expenses were $18.6 million, consisting of $13.2 million for R&D and $5.4 million for general and administrative expense. Loss from operations was $18.6 million. Interest net expense was $0.3 million. Gain from valuation of warrant liability was $2.4 million.
Cash and investments ended at $127.3 million. $46 million was raised in April through a stock offering; warrant liability is in balance sheet. This compares to $99.6 million cash and investments at the end of Q1. Net cash usage was $21 million.
The Independent Data Monitoring Committee (IDMC) is scheduled to complete the interim analysis of overall survival in the Phase 3 IMPACT Provenge for prostate cancer study in October 2008. We have passed the event milestone triggering the interim analysis. But remember there is a higher probability of success on the final analysis than on the interim analysis.
A Phase 2 study (NeoACT )using Provenge with patients with localized prostate cancer undergoing prostatectomy was initiated. Another Phase 2 study (ProACT) for patients with metastaic, androgen-independent prostate cancer will start this month.
Preclinical data on D-3263 indicated it may be active against benign prostatic hyperplasia (BPH). May be active against other cancers as well. IND to be filed later this year.
NeoACT timeline? Single site study on prostatectomy just began enrolling its 40 patients. We don't know how long it will take to complete enrollment.
Blood versus tissue immune response? Cancer patients have an immunonsuppressive environment. We create immune cells outside the patient. The NeoACT trial may shed some light on this.
SEC investigation resolution? Cooperated with SEC and pleased with outcome.
Auction rate securities on balance sheet? None.
Commercialization plan? Plan in U.S. is to build our own commercial organization, but to seek a partner outside the U.S.
D-3263 cancer types? Solid types like breast, colon, and melanoma in addition to prostate.
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