some questions answered by ceo

Hiya, I ended up emailing Larry in the end with some questions. Larry's answers in bold...

Q1. In relation to the Perseis program becoming a core program of Neuren's, how does this impact the current ownership and funding structure with Breast Cancer Research Trust?

Ans. As long as both NEU and BCRT contribute their proportionate share to fund the program, the ownership structure won’t change. For the initial work with Noble (establishing a stable cell line and conducting a xenograft study with the new antibodies), the cost is modest (~$100k). This is work that would have had to be part of the program going forward in any case.

Q2. The Breast Cancer Research Trust had previously indicated that Perseis Therapeutics was in discussions with "Big Pharma" and that "Big Pharma" had required a further piece of validation (which I assume they were referring to was the recent xenograft results). Is this "Big Pharma" still around and interested ie is it a matter of presenting the new xenograft results to them?

Ans. Without going into any specifics, yes, we still have interested parties .

Q3. In terms of the recent xenograft results, I've not had much experience investing in cancer related companies so am unsure about the significance of a 35% reduction in tumour volume and a 3 fold survival rate increase. Is there any chance you can put this result into some kind of context (e.g. how it compares with other drugs for this indication, whether it met or exceeded Neuren/Perseis Therapeutic's expections, etc)?

Ans. At this stage of development (i.e., before the cell line and antibodies have been optimized), 35% compares favourably to other cancer antibody therapeutics. I guess the best way to put it is that the results reinforce our commitment to the program. Remember that, while this is the first in vivo result with a monoclonal antibody, in vitro and in vivo polyclonal antibody results have been consistently positive as well and the clinical epidemiologic data related to the impact of TFF expression on tumor spread and patient survival is extremely compelling.

Q4. In relation to the Intrepid trial, it has been mentioned in the Annual Report and at the AGM that SAEs and mortality rates have been lower than other TBI trials (which is good news for patients). Just a quick question about the mortality rate - does the mortality rate differ between the cohorts e.g. did the deaths occur in earlier or later cohorts?

Ans. There have been too few deaths to calculate a meaningful dose-specific mortality rate but the number of deaths has not increased with dose. Remember that mortality is a safety endpoint, not an efficacy endpoint. If, for example, a drug were to result in fewer deaths but more patients in a persistent vegetative state, that would not be considered a clinically meaningful benefit and would not be “approvable”.

Q5. In relation to the significant delays with the Intrepid trial and the impact of this delay on its patent life, is the FDA/USPTO's Patent Restoration Program an avenue open to Neuren to seek patent extensions for IV NNZ-2566 (should it successfully complete clinical trials)?

Ans. The key composition of matter patent expires in 2023 without patent restoration but, yes, extension via patent restoration is available. Some of the other utility patents have later expiration.

Q6. This has probably already been explained to shareholders before, but could you confirm Neuren's % rights ownership and % funding obligations (viz its partners like the US Army etc) for these programs:

* NNZ-2566 (IV) - we own rights to non-military market, we fund 50% of trials?

Ans. We own all rights in all markets; the military gets to buy drug at cost and, at least for the Phase II trial, are covering all direct costs.

* NNZ-2566 (Oral) - we own rights to non-military market, we fund 50% of trials?

Ans. As above.

* NNZ-2566 (Rhetts) - we own 100%, we fund 100%?

Ans. Correct although, being big proponents of non-dilutive funding, we’re actively seeking grant funding for this program as well.

* Motiva - we own 100%, we fund x%?

Ans. Other than IP, the only cost right now is for the ongoing trial at UWA which is covered by the NHMRC.

* Perseis - we own 75%, we fund 75%?

Ans. Correct.