1. Milestones for 2010: A. Advance one or two proprietary discovery programs into development. B. Advance one or two partnered discovery programs into development. C. Partner one or more proprietary programs. D. Increase cash balance (~$115 million as of 12/31/09) through partnering and drive down burn rate (anticipate burn going from $20 million per quarter down to $15/$16 million per quarter).
2. In talking about partnering, attention was focused on ARRY-403, ARRY-380, and ARRY-162. Since ARRY-403 was already partnered with AMGN, I would expect that if there are any partnered compounds in 2010, they will most likely be ARRY-380 or ARRY-162.
3. Partnered Compounds
A. ARRY-403 - Partnered with AMGN (http://investorshub.advfn.com/boards/read_msg.aspx?message_id=44521107&txt2find=ARRY ). ARRY will complete the Phase 1b multiple-ascending dose trial this quarter. AMGN is responsible for all development from Phase 2 forward. ARRY will receive $5 million per year for the next two years to work on 2nd generation glucokinase activators. B. AZD6244 (Mek inhibitor)- In two Phase 2 trials (NSCLC and melanoma) and six single-agent trials are being conducted by the NCI and AZN. There is also the Phase 1 combo trial of AZD6244 and MK-2206 that has just begun Phase 1 (http://investorshub.advfn.com/boards/read_msg.aspx?message_id=45151983&txt2find=ARRY ). C. LY2603618 - CHK-1 inhibitor developed in collaboration with ICOS, which LLY acquired in 2007. LLY has advanced this compound into Phase 2 for cancer.
4. Proprietary Compounds
A. There was no mention of ARRY-797 in 2010 milestones so I assume this compound is effectively shelved. B. ARRY-162 - Robert Conway, the CEO, referred to MEK as the "O'Hare airport of cancer treatments." Three Phase 1 cohorts have been completed and they are now into the fourth cohort. There is apparently still "significant partnering interest" in the compound. Expect to complete and report Phase 1 dose escalation results in 1H2010. Expect to initiate and complete a Phase 1 expansion in biliary tract cancer and initiate a Phase 1b combo trial in 2010. C. ARRY-380 - Completing Phase 1 dose escalation study. ARRY announced positive interim results in December (http://investorshub.advfn.com/boards/read_msg.aspx?message_id=44469826&txt2find=ARRY ), including responses in 8/10 patients, 4 of whom had prolonged stable disease past 16 weeks. Expect to complete and report Phase 1 dose escalation results and also initiate and complete a bioequivalence trial to enable a commercial formulation in 2010. D. ARRY-543 - Expect to complete three Phase 1b combo trials and report results in 1H2010. Also expect to initiate a Phase 2 combo trial in pancreatic cancer and look for other opportunities for the drug. E. ARRY-614 - Expect to complete and report Phase 1b trial results in 2010. F. ARRY-520 - Expect to complete and report Phase 1 expansion in solid tumors and a Phase 1b in AML/MDS. ARRY anticipates the most important event for ARRY-520 to be completing and reporting Phase 1b results in multiple myeloma and the initiation of a Phase 2 trial.
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