Questions For Conference CallOut of the following 33 questions please vote on your top 5.
1. Why won’t management take more compensation in options if they are so confident in the drug and feel the share price is so undervalued?
2. Do you plan on adding any personnel to the management team in the next little bit?
3. What experience does Dr. Sokoll have in taking drugs to and through trials?
4. Now that Dr. Sokoll has been with GAP for over a year, how would Bob rate him for an annual evaluation?
5. For a drug that isn’t in trial stage, why all the PPs to cover unnecessary overhead?
6. Is Stormont considering putting further money into PharmaGap?
7. Do you have any plans in place to generate momentum and investor interest?
8. What is the common response from institutional investors/mutual funds regarding GAP? What benchmark or results do they require before they participate?
9. How do you plan to pay for the actual trial?
10. In 2008 you put a team together to bring PhG- Alpha1 to trials. Gary Schwartz, Barnes, and Cowart. Memorial Sloan-Kettering Cancer Center was big on Melanoma and now we hear nothing. Any update?
11. We know that there are other drugs in the pipeline, What update if any can you give us about MDBiosciences and Theta?
12. There are 2 formulations of GAP-107B8. It looks like you are having a lot of success with both, but possibly more with formula 2. My question is what is the difference and will the previous testing performed for the original compound have to be repeated if that is the better of the 2 formulations? Does your patent cover multiple formulations?
13. Describe what you know about other companies who maybe pursuing the same/or similar technology and is there a risk they move trials and or the market before you?
14. The MSKCC testing showed inhibition of PKC alpha/delta, MTOR and MAPK but the OHRI testing on ovarian cancer has talked about inhibition of PKC iota. Are you beginning to ascertain the MoA for the various cancer types? The PBS-BIO studies alluded to this and I am curious about how the compound works differently in different cancer types. How is GAP-107B8 different from peptide inhibitors currently undergoing trial? Even though PKC alpha has long been a recognized cancer target, why have so few compounds had success? How is GAP's compound different i.e.: more selective, more potent, less toxic?
15. With all the success in NCI testing and in 2009, NCI saying (at least in PGAP NR) that they would be assisting in further development and then further great results from the 5 dose testing (performed twice) why nothing further has been done with NCI. To me, there is a constant need of funding to get this compound to the point of clinical trials so I have always expected to hear of NExT Program application/acceptance, or some sort of CRADA or the like. It was just something I thought would make sense to decrease the amount of money raised/dilution to share price with having to do many PP's to get this to Phase 1. In the powerpoint presentation from August there was a reference to NCI with a + after it which again caused me to wonder if there may be some assistance coming from that direction.
16. Can you tell me a little more about Liposomal delivery? It sounds like GAP-107B8 assaults the plasma membrane of cells (PBS-BIO) and that there is very little/no toxicity. Is it due to the half-life that this delivery method will be more advantageous? I admit to not knowing much about peptide delivery methods. Will this liposomal delivery system allow for different routes of administration and higher success?
17. Where is the money that is being raised going? Can you break it down into percentages for each area on average?
18. With all that you have done, and successful test results, why in the past year have you taken on a new cancer and delivery method? What was wrong with Ovarian cancer?
19. What variables are you taking into consideration when determining what cancer to target?
20. Can you do more than one phase I trial if you continue to see success in Both Ovarian and Bladder cancer?
21. When do you expect to have a preliminary filing for clinical trials drawn up?
22. Who is putting together the application for clinical trials?
23. Who is PharmaGap’s regulatory and clinical trials expert?
24. Are you still on track to file for clinical trials in December 2012. How likely is that deadline?
25. If you file for clinical trials in December 2012, when would you expect to start clinical trials?
26. If you file for clinical trials in December 2012, when would you expect to be through phase I?
27. How much do you expect phase I to cost if you want to proceed as quick as possible?
28. What do you have left to do to be ready to file in Q4 2012?
29. Where do you plan on doing the trials? Who will conduct them?
30. Why the constant delays in filing for clinical and the retesting?
31. Is it possible to monetize your drug treatment towards one of the cancers and use the proceeds to advance the other?
32. What is the common response from potential licensing partners regarding GAP? What benchmark or results are required for them to participate?
33. GAP’s product, if successful, will likely threaten the revenue stream of other pharmacy companies, describe the challenges and/or road blocks that this could present?