Looks to be the same slide deck at today's corporate update as last week's slide deck from the BIO Investor Forum. I will compile my comments from last week here and add in anything new I heard today.

ZEN-3694 + Enzalutamide for mCRPC: Phase 2a mCRPC trial (AR inhibitor resistant) nearing completion. Expected to be officially done November 2019. Last patient visit 11/19. An amazing property of ZEN-3694 is that it can be dosed every day without the nasty side effects of other pan-BET inhibitors. Longest patients on drug for ~140 weeks! "Very exciting opportunity for us and it will move forward in other partnerships and in my opinion, preferably, even M&A."

Trial results recently presented in a Prostate Cancer Foundation Retreat 2019 poster "Results from a Phase 1b/2a study of the BET bromodomain inhibitor ZEN-3694 in combination with enzalutamide in patients with metastatic castration-resistant prostate cancer (mCRPC)."

Full responders will be moved into future trials including this one "Continuation Protocol for ZEN003694 in Patients Experiencing Clinical Benefit While Enrolled in a ZEN003694 Protocol."

They had a meeting with the FDA and have received very positive FDA feedback for design of a Phase 2b/3 registration enabling study to compare enzalutamide single agent vs. ZEN-3694+enzalutamide combo for mCRPC. The current Phase 2 lacks an enzalutamide alone standard of care group. So this new trial would prove superiority. FDA brough up potential for fast-track approval from this Phase 3!

This Newsoara licensing agreement for ZEN-3694 for China, Hong Kong, Taiwan, and Macau seems to be extremely promising. Completion of the ongoing but soon to be completed mCRPC trial is trigger for $5 million payment from Newsoara. In the webcast, Don mentioned that "We are moving forward very fast in China. We expect some approval from the CFDA as early as January. We are doing that with our partners in China, Newsoara, who pay for 100% of that program." I'm not exactly sure how to interpret all of that in the context of the planned Phase 3 trial.

ZEN-3694 + Pfizer PARP inhibitor: Phase 1b/2 TNBC Pfizer trial of PARP inhibitor Talazoparib and ZEN-3694 now has 10 prominent clinical sites and investigators, including some from Belgium and Spain in addition to US. The Phase 1b portion (safety, pharmacokinetic, pharmacodynamic and Phase 2 dose finding) is nearing completion. They expect to start the Phase 2 portion by end 2019 or early 2020. Pfizer is paying for 50% of this program.

UCSF trial with ZEN-3694, Keytruda and Enzalutamide: Phase 1b/2 immuno-oncology trial has been initiated by UCSF to test ZEN-3694 in combo with Keytruda (pembrolizumab) and enzalutamide for AR independent mCRPC and possibly other cancers. Key is to restore sensitivity to immune checkpoint PD-1 and PD-L1 antibody therapy. UCSF is paying for this 100%; Zenith is simply providing the ZEN-3694.

BearDownAZ