Exelixis, Inc. (EXEL)

PDTBiotech (25.59) Submitted: 5/08/08 1:58 AM : Start Price: $6.90 EXEL Score: -10.02

Exelixis (EXEL) develops drugs for the treatment of cancer and other proliferative diseases. I had been looking for a decent entry point, and today's 11.65% drop on their earnings release looks like a decent one. The drop is most likely due to the 1Q loss of -0.39 vs. last year's -0.25. Since this is a development-stage company with all of their clinical compounds in Phase I or II studies I don't think this is surprising, as they spend more money on R&D while they advance their compounds through the clinic.

EXEL is developing drugs to a wide, and well-selected, number of oncogenic targets. They have a nice mix of compounds, and a well-thought-out pertnership mix. Here's a look at their pipeline, which I consider to be robust:

*XL647 - EGFR, Her2, and VEGFR inhibitor - in Phase II trials for Non-Small Cell Lung Cancer (NSCLC). Outlicensed to Symphony Evolution, Inc. Has shown good efficacy in Phase II trial (350mg on days 1-5 of a 14-day cycle), with 68% of patients showing clinical benefit. Plus: ~190,000 new patients per year in the US, and one of the worst survival rates of all cancers means the bar is low to get approval and there's a huge patient pool. Minus: everyone and their grandpa is developing inhibitors to these RTK's.

*XL880 - MET and VEGFR inhibitor - in Phase II for papillary renal cell carcinoma (PRCC) and gastric, head and neck cancers in collaboration with GSK. 79% of patients in the PRCC study have had tumor shrinkage, and they saw 5 partial responses (at leats 30% shrinkage) in the Phase I trial.

*XL184 - MET, RET, and VEGFR inhibitor - in Phase I for solid tumors for which there are no available therapies. GSK has opt-in agreement (not exercised yet). It's only Phase I, but they've seen some good responses, particularly in medullary thyroid cancer patients. Have not determined MTD yet.

*XL820 - KIT, VEGFR2, and PDGFR inhibitor - in Phase I trial for patients with advanced solid tumors; GSK has opt-in rights. MTD not determined yet, no reports of responses or lack thereof yet.

*XL844 - CHK1 and CHK2 inhibitor - in Phase I in combination with Gemcitabine (Gemzar - LLY) for solid tumors. GSK has opt-in rights. Novel approach - CHK1 and CHK2 are cell cycle checkpoint proteins which stop division following DNA damage. XL844 inhibits them so the cancer cells will continue to divide, making them susceptible to radiation and DNA damaging agents (Gemzar is a nucleoside analog). No trial data yet.

*XL281 - B-RAF, C-RAF inhibitor - in Phase I for advanced solid tumors, GSK has opt-in rights. No data yet, looks like they're steering it towards melanoma.

*XL228 - Bcr-Abl, IGF1R, and Src inhibitor - in Phase I for CML and ALL, GSK has opt-in rights. No data yet, presumably would have to outperform Gleevec or show activity in Gleevec-resistant tumors.

*XL518 - MEK inhibitor - Phase I for advanced solid tumors, in collaboration with Genentech. Still recruiting, looking like they'll go with melanoma or colorectal cancer.

*XL147 - PI3K inhibitor - Phase I for solid tumors, wholly owned by EXEL. No data yet.

*XL765 - PI3K and mTOR inhibitor - Phase I for solid tumors, no response data yet, wholly owned.

*XL019 - JAK2 inhibitor - Phase I for patients with myeloproliferative disorders (polycythemia vera, essential thrombocytosis, and idiopathic thrombocytosis), wholly owned by EXEL. Well tolerated, has shown activity in Phase I. Awesome target - STAT3 activation, downstream of JAK2, is common in many cancers, they could expand studies to look at many different diseases with this drug.

Since their most advanced compounds are only in Phase II the very earliest I'd expect to see them generating revenue from sales/royalties would be at least 2011. For the next few years they'll most likely be trying to determine the best indications for each drug and focusing how they want to proceed with development. With 11 candidates to proven targets, they're in great position to get several to market if they can stay afloat, and their partnership structure looks like it will get them there.

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