Zenith Epigentics and Resverlogix update 22 Jan 2018

Look what's been in my inbox for about a week. Have just glaced at this board once in a while over the last 10 days & see some posters lammenting over the cold weather. I highly recommend Puerto Vallarta to update your sandle tan.

Zenith Epigenetics and Resverlogix update 22 Jan 2018

Source - Undisclosed director

Q: question, A: answer, MT: my thoughts

Zenith Epigenetics

Q: At the Bio Show Case in San Francisco a couple of weeks ago there was little update on the progress of the patients in the ongoing combination trial, where are they at now?

A: The patients in the second cohort are now up to 43 weeks. The maximum tolerated dose for the single agent trial of 60mgs has now been exceeded in the combination trial.

MT: It doesn’t take rocket science here to see that significant additional revenue can be gained by any potential suitor as a result of 9+ months of additional life for any percentage of patients. Gross annual sales of enzalutamide plus abiraterone are about $6 billion. Adding nine months of additional sales for the patients that respond to the drug could be quite profitable. Put another way, adding about $2500 per week per patient of additional revenue past 10 weeks on the combo should eventually elicit an offer.

Q: Will there be a Private Placement for Zenith or a sale of ZEN-3694?

A: Both hopefully. We have to keep money in the till so we will likely do a PP to keep the trial going until a sale can be closed assuming there is continued success in the trial.

MT: Like it or not it’s the way it is. Even if there was an all cash offer today it could take some time before it closed. Keeping the science moving forward is important for all of us. Keeping the doors open is vital!

There was a patent challenge regarding abiraterone acetate and J&J in the news on 17 Jan 2018.

Q: How will this patent challenge affect ZEN-3694 as it is being tested in combination with abiraterone?

A: This is just round one of this patent challenge. J&J has said they are going to vigorously defend their patent. Don’t jump to any conclusions; this could take years to play out. It could end up being quite positive for us as we could end up being in combination with a number of generics for a long time. J&J has also developed a new drug that has now finished a Phase III trial and has applied for final approval. We have also tested this drug in combination, pre clinical, with very positive results.

MT: They are aware of what the potential pitfalls and opportunities are that surrounds them. For info on the lawsuit go to:  https://www.google.ca/patents/US9056103?dq=who+is+claiming+patent+infringement,+Johnson+%26+Johnson,+ZYTIGA&hl=en&sa=X&ved=0ahUKEwjKxIncie_YAhVJ12MKHda1BWAQ6AEIKTAA

It looked to me that the first filing of this patent was May 17, 2002. That would only leave 4 or 5 years of patent life. Good call on the generics! This situation may end up being a win, win, win for them.

Ziopharm Oncology(ZIOP) has been in the news lately with their CAR-T drug that controls IL-12 with regard to Glioblastoma.

Q: In the microarray analysis that you have done for both ZEN-3694 and RVX-208 is there any positive effect on IL-12?

A: Yes we do have a positive effect on IL-12 without even having it as a target. The effect is about one half of what Ziopharm’s drug has.

MT: Just get the first deal done and the world will beat a path to our door.

Resverlogix

Q: Can we talk a little about Resverlogix as well?

A: Since you have me here now fire away. I can not be as open with Resverlogix as it is a public company which has a number of restrictions on information dissemination.

Q: Did the change in the timing of the Futility Analysis have anything to do with the RVX-208 potentially working to well?

A: No.

MT: The trial has always been designed to go for 3600 man years of dosing. That equates roughly to 2400 people dosed for an average of 18 months. They are currently estimated to be at about 1200 man years. As stated in the 11 Jan 2018 news release, there are now over 2200 patients enrolled in the trial. Once they hit 2400 enrollees they will be gaining approximately 500 man years per month. If this trial roughly follows the path of other completed trials their estimate of  Top Line data in Q4 seems realistic. There will be a News Release the day the first patient is enrolled in the US that will detail what will happen in the US. We had the NR on 11 Jan stating the FDA’s acceptance of the Phase III BoM trial protocol amendments. It shouldn’t be too long before we hear that the first patient is enrolled in the US. We are getting pretty close to full enrollment now.

Q: Are there still other clinics around the world that are recruiting in addition to those that will be recruiting in the US?

A: Yes

MT: Hopefully recruiting should be complete before the end of H1. With less than 200 patients left to be recruited that leaves just a few patients to be enrolled at each active clinic. Looking forward to the day recruiting is completed.

Q: Do you get any information at all about the patients in the trial?

A: Yes, we get gross Blinded data only.

Q: Is there any particular theories you can discern from the information that you do receive?

A: Lots. Our scientists can make educated guesses based on the information that we do receive but that’s all it is, an educated guess. Would you like to know the number of adjudicated events as of today?

Me: You betcha.

A: Too bad you will have to wait just like everyone else.

MT: SOB I walked right into that one.

Q: Can you fill in a few blanks on the Israel deal announced a couple weeks ago?

A: No. You will hear more at the same time as the rest of the world. It is good news though.

Q: Regarding the Beacon Report, how come they use a 2% market penetration and you use a 64% market penetration?

A: They have a formula that they use which is somewhat different than what we use. That is obviously a really big gap, almost comical on both sides. We are about 80% of the way through the BoM trial at this time and have had no significant safety concerns. We have patients that are now coming out of the trial as they have been in it for 2 years now. If there is any concerns that come up at this point it will likely be in the liver as that is where the ALTS issue was early in the trials. That issue went away on its own early in the trial(s). So far is looks like we have a clean, safe drug and trial. We should have the Top Line readout late this year and we will go from there. In the mean time you will hear about Analyst updates, US recruiting starting, the Sample Size Re-adjustment, recruiting completion and other pieces of news as we disseminate it.

Q: Where will the money come from to finish the trial?

A: There are a number of irons in the fire. If we have to go to the market you know that we will raise the minimum we need to to finish the trial.

Q: Are there still LOI’s outstanding?

A: Yes.

MT: They know they have a responsibility to the shareholders to complete the trial and will make every effort to make sure that the funds will be there to do so. Double blinded trials are such a pain for a company that doesn’t have multiple trials happening. The information vacuum is tough for investors to handle. This is the wrong time for anyone to get investor fatigue with us being so close to the end of a Phase III outcomes trial.

Thank you for your time.