Just some questions for Tuesday and to get people thinking. How...

Just some questions for Tuesday and to get people thinking.

How many patients in Cohort 4 have been dosed?

What is the total number of Cohort 4 patients?

Have you received any data from Cohort 4 to date?

When will the preliminary data from Cohort 4 be known?

There is new concern that trial results are not as expected. Did any data (good or bad) from the trial from any Cohort (1-4) play any role in the decision to cease the trial?

Given that there is no Cohort 5 the data from Cohort 4 becomes the defining data. How important is this data to the company’s future? What are you looking for to validate efficacy? SVR 24?

Was the decision to halt the trial based purely on the competitive landscape for HCV? If it was why did the company take so long to halt the trial given that the commercial opportunity was never really there for some time? Did anything change just recently?

Many investors were only in this stock for the efficacy of the HCV trial. What do you say to these investors?

If the Cohort 4 data is not favourable how can you justify moving into another human trial using the same science?

How does the decision to finish the trial early affect current plans for the HBV pre-clinical trials?

Does the company have had to wait for Cohort 4 data before commencing HBV clinical trials?

The market has destroyed the stock in reaction to this announcement and sees nothing positive. $20 wiped off the market cap and trading below cash levels down 90% in the year. The clear message is it is a disaster for the company. How did you not see that the announcement, in terms of its timing and the way it was written wouldn’t destroy the stock? What was the benefit of releasing it now as opposed to after Cohort 4 when you would have data?

Was it the company’s original plan to proceed to HBV clinical trials with completed Cohort 5 HCV safety and efficacy data? How can you remain confident of new clinical trials without this data?

Did you consult the FDA before terminating the trial? How does the FDA treat data from an unfinished trial?

The company constantly promoted the TT-034 trial as a proof of concept and value adding trial, rather than building to a commercial outcome. By terminating the trial has this entire value been lost and can you even say you have officially proved anything?

How does everything established and learnt for the HCV trial impact the HBV human trial?

Can we start at ‘Cohort 4’ levels? Is the IND process as onerous?

Has the company wasted years of time and shareholder capital? Is the company starting from scratch again with HBV?

The IND is Q3 2017 so the HBV clinical trial will not start until 2018, some 4 years after the HCV trial started. Is this also going be a proof on concept trial? After HCV how can you expect shareholders to be interested in funding and waiting till 2020 for results when the exact same thing may happen? We thought we were getting proof of value this year, otherwise what was the point of the IPO?

When will further funding be required and how do you intend to obtain this funding? It would appear that funding will last only another year based on the current cash burn.

Salaries seem way too high and out of sync with the dismal market cap. There seems to be a number of redundant roles within the company which are draining company funds. What is the role of the Chief Business Officer and what are the KPIs?

Unlike HCV You keep talking about lots of interest in partnering for HBV. You specifically said the “company continues to generate strong interest from a number of potential partners with a particular focus on hepatitis B, AMD and the ddRNAi platform”. What does this even mean and what is required to secure a partner? In vivo data (which I believe is due in next few weeks)? Are any of these partners waiting for HCV Cohort 4 data? Is the company stringing investors along? Where is the evidence that any partners are genuinely interested in BLT’s other programs and have any offers been rejected by the company?

As of Friday (if not well before) Australian investors have turned away from the company and cannot be expected fund ongoing clinical programs. Without a partner the company is in a distressed situation. Are you going to burn all the cash before getting a partner? Are you trying to sell the company? How can some value be leveraged before all the cash is gone?

Overall what has changed apart from Cohort 5 not being done as the cost savings seem relatively small compared to the crossover benefits and value driver of a completed and trial with accompanying data?

Investors are in a state of shock and aggrieved. The company’s management of expectations has been abysmal. The market now places zero value on any of the company’s clinical programs. Since the IPO you have destroyed rather than create shareholder value culminating with this unexpected implosion. The company’s value more than halved from an already all time low price. The bottom line is the decisions the company has made have now left long term holders with virtually nothing. You have not repaid investors’ trust. Do you take any responsibility for the largest ever sell off of the company’s stock?

After all the money raised over many years and all the so called inflection points, the company is now valued well under US$10mil and below cash backing. The pre-consolidation price is less than half a cent so how will the cycle of wiping out investors not repeat? All the research and analyst comments, shareholder comments since the announcement include one word – disappointment. Although NASDAQ volume was comparatively low it was still 6 times above the NASDAQ average and fell 55% on Friday which matched the ASX fall. You did an IPO in 2015 as you wanted to be exposed to the US capital markets when the value inflection point occurred. Where is this value inflection point now that you have ceased the only human trial that was very close to this point?

Is ‘big pharma’ really interested in a one-shot cure for anything? How is this consistent with their business models which rely on repeat business? Can we expect the competitive landscape for HBV to change in a few years like what has happened with HCV? Why should things be different?

This article encapsulates management failure. How do you respond to this?

Benitec Biopharma (NASDAQ:BNTC) has never been good at communicating with its shareholders but its latest effort has got to be the worst example ever!
Okay, the company has to inform the market about ending the TT-034 trial but the language and style of the announcement was guaranteed to spark a sell-off and that is exactly what happened on the ASX. The news was not good news. I get that. But why make it even worst with a style of delivery that reeks of doom and gloom?
It could be that, along with the termination of the last CEO, the Board is finally making hard decisions. This could be a good thing and one that will ultimately be seen positively by some potential partners. I, and many others, have been critical of management and the Board over the last twelve months or so. Now that the Board has finally gotten some backbone and made a couple of hard decision, perhaps there is actually some light at the end of the tunnel?
TT-034 was always going to be difficult to commercialise and the major benefit of the trial was always going to be its crossover to the HBV program. So, what the company should have said was that they have decided not to proceed with TT-034 cohort five, with results still to be made available by year's end.
The announcement could have gone on to say that, with limited funds available, the cash saved though not dosing cohort five will be siphoned into the other programs - which remain on target in their development.
These words would have conveyed the same message as the company announcement but at least shareholders would have had a more positive view as to why this action has been taken.
That said, there are some serious implications of today's action on the ASX and what is likely to happen on the NASDAQ. The company is trading at less than its cash reserves. This makes it a target for any cash strong company to acquire. Corporate shareholders may see this as their best exit strategy and actively support such an action. This will not be good news for long term holders who purchased their shares at much higher prices.
The company has stated that HBV is now to be its main focus but without more data from the TT-034 trial, how can any investor be sure that the stated crossover benefits of the HCV/HBV programs will eventuate? If the benefits are not there, then the HBV program will have no leverage and will have to go back to the drawing board. Were this to be the case, how would the company raise the capital necessary to fund the further development of its pipeline?
Yes, today's news is very disappointing and has some very serious ramifications but if this is the start of better management, and sound management is a major consideration of big pharmas when they partner, then perhaps all is not lost? The question is, can a new CEO resurrect the company's potential before the next capital raising? It will be a difficult task but not impossible if a pharma starts to take an interest but time is running out on that score.