Some Zenith notes of mine from today's corporate udpate. I may have mis-typed or misunderstood things, so DYODD for sure. I wasn't there, so I missed the AGM portion and post-webcast Q&A. I'm not sure if DM provided any further clarification on the royalty preferred share issue or anything else during those portions of the meeting.

Zenith has several patents, a dozen or more, at various stages of examination and issuance. They are following a new process in a US Fast track patent approach that was granted in March. You break down patent into most important component and you put that through the fast track. They expect it to be finalized Q1 2017. The rest of the patent will go normal process and this can take 3 years. Need published patent to get a licensing deal over the finish line in China and other countries. Once you have fast track patent approved, the follow on patents in subsequent other countries happen very fast.

Great overview of mCRPC program. In vitro, strong evidence that ZEN‐3694 synergizes With Enzalutamide & ARN‐509 and that is basis for mCRPC single agent and combo therapy trial. ZEN‐3694 single‐agent study ongoing. No enrollment issues. Moving along real fast and excitement level is clearly showing in the principal investigators. They have found the Maximum Tolerated Dose (MTD) confirmation and know the dose limiting toxicities (no surprises) and this was all done in 6 months time. They seem to be happy with its pharmacokinetic profile, IC50 cell proliferation values, target modulation and on-target safety profile, though they didn't go into details. Longest patient on drug now beyond 4 months. They've been doing daily dosing for MTD determination but are considering adding an intermittent dosing schedule cohort in Q1 2017 in their efforts to determine the recommended Phase 2 dose.

For the combo ZEN-3694/enzalutamide Phase 1b trial: UCSF and MSKCC are now open for enrollment. They are starting at 36 mg QD ZEN‐3694; 160 mg QD enzalutamide. However, I'm not sure what the starting or maximally tolerated dose was used in the single agent ZEN-3694 trial, so hard to put this into context. DM indicated that early data sets start showing up in a couple months for the combo trial.

Overall, DM was very excited about combination therapies. For example, ZEN‐3694 is synergistic in combo with Paclitaxel in triple-negative breast cancer (TNBC) model. Also DM seemed very excited about opportunities to do combo therapies to synergize with current immuno-oncology drugs. In combination drugs, you know who a potential partner may be. Some of these companies, they're trying to get them to pay for the combo trial because clearly it’s going to benefit them. It is a mechanism of keeping costs down and lining up future partners. 

Biology expansion ongoing into other indications: Immuno‐Oncology, Triple-negative breast cancer (TNBC), non-small cell lung cancer, ER+ Breast Cancer. They can enter this market with same drug. Already IND’d and have safety data for ZEN-3694.