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mcbio

09/11/17 10:18 PM

#213575 RE: DewDiligence #213543

EPIX -48%/PM on termination of EPI-506 program

Not exactly clear to me how they are going to develop their follow-on program insofar as they were running on fumes as it was.
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mcbio

01/31/18 9:41 PM

#216980 RE: DewDiligence #213543

EPIX @ Noble

http://noble.mediasite.com/mediasite/Play/771606a950c14c9da74e5bf0bb3a06271d

[Good to see they finally raised a big chunk of cash (even though at very dilutive levels). Also good to see they are presenting at conferences and webcasting now.]

1. IND filing of next-gen Aniten compound (2nd gen version of EPI-506) expected by 1Q19.
2. Estimate of 60% of mCRPC tumors post-Xtandi or Zytiga failure may still be androgen receptor driven.
3. Claimed safety issues arose from the exceedingly high levels of the prior drug, EPI-506, because the drug was in a castor oil excipient.
4. Prior drug did not shut down androgen biology a full 24 hours (at best, effect seemed to be out to 12 hours for highest dose). The problem was not absorption of the prior drug but metabolism. Believe they now understand where the metabolic vulnerabilities were with EPI-506 (in the liver).
5. Next-gen drugs are 10x more potent and less susceptible to metabolism.
6. In next trial, EPIX will characterize patients' circulating tumor DNA and look at gene expression driven by androgen receptor (assays newly available for this) and allow them to select the patients that progress on Xtandi that still have an activated androgen receptor and whose tumors are still driven by androgens.
7. For these next-gen Anitens, EPIX started with 150 compounds that they have now narrowed down to three. Will select the most optimal molecule in the next few months.
8. Made comment that continue to work on the side to see if it's possible to get even greater potency but CEO stated wasn't sure if this was necessary (still makes you wonder if this foreshadows a possible concern with the initial 2nd gen drug).
9. All of the competitive drugs, including JNJ's apalutamide, work through the C-terminal domain, which is where mechanisms of resistance arise, whereas EPIX drugs work through N-terminal domain so a point of differentiation.
10. After recent financing, EPIX has 159M shares outstanding.