I yesterday attended an investor presentation with the Benitec team. In my view, Peter French and David Suhy continue to exhibit an extremely high quality of professionalism, appropriate conservatism, strong business acumen and underlying confidence in the technology and its future prospects. Furthermore, they are ably supported by a highly qualified Board, executive team, and a growing staff of hand selected professionals. In my view we have the A-team on the case, and the best thing us shareholders can do is provide strong support from the sidelines.
There are a number of publicly available points of discussion that I felt are worth reminding ourselves of in the context of current market gyrations:
1. TT-034 is a FIRST-IN-MAN clinical trial. Once administered, it CANNOT BE REVERSED. It is entirely appropriate that the bar has been set higher than ever before to ensure firstly that safety parameters are achieved, and secondly that the screening, selection and appropriate management (including rejection) of patients is maintained at a standard that is beyond reproach. The 'ins and outs' of the clinical trial for TT-034 seem to be a source of particular focus for shareholders. Why aren't they moving more quickly? Why didn't they have another patient lined up? Why can't they recruit patients across multiple sites simultaneously? Are they sure they know what they're doing? etc etc etc. Ask yourself this: if you were sitting on a breakthrough technology capable of changing the face of modern medicine, would you be cutting corners, taking risks, skipping key inclusion or exclusion criteria, running shy of the regulatory requirements, or operating with a team that was not 100% capable of achieving the trial objective? I am personally extremely thankful that Benitec is taking an appropriately measured approach to the clinical trial. It needs to be done right, all identifiable risk must be mitigated along the way, to ensure maximum opportunity for the technology to achieve the trial objective: the complete and sustained elimination of the Hep-C virus with a single injection. Enough said.
2. The AAV8 vector is effective in delivering TT-034 to the liver. This seems to have gone somewhat unnoticed in recent weeks, despite the clinical trial patient population of n =1. There was much consternation on these (and other) boards some months ago about the potential lack of suitability of the AAV vector. With it came volatility in the share price. Funny, that line of discussions seems to have gone very quiet now! The technology is complex. Very, very complex. Yet here we are...embarked on a first in man trial, with no adverse safety events as a result of TT-034 dosing, with transduction of the liver cells confirmed, and with production of low levels of shRNA in the liver cells, and support from the DSMB to continue the trial as planned. Make no mistake, if this clinical trial achieves its objectives, Benitec is on the verge of a truly remarkable medical milestone...and all the rewards that come with it.
3. Benitec has a broad pipeline of programs, at various stages of progression towards the clinic. Success in TT-034 will effectively validate key elements of current risk associated with these programs. In particular, the Hep-B program will receive an enormous slingshot should TT-034 prove both safe and efficacious. It was pointed out yesterday that there is a reason 90% of Alnylam programs are focussed on the liver - siRNA is extremely difficult, and even a company the size of Alnylam (capped at around USD 4.2B last time I looked) needs to focus on the area it understands best...the liver. Then there is Benitec (capped at around AUD 100m+), with current programs in Hep-C, Hep-B (Liver), Non small cell lung cancer (Lung), Cancer associated pain (Central Nervous System/Neuronal), Age-related Macular Degeneration (Eye/Retina), and Oculopharyngeal Muscular Dystrophy (Muscular). Get the picture? Benitec is a platform technology that is effectively disease agnostic and with the potential to pilot cures across a portfoilio of programs for a range of orphan diseases (i.e. diseases for which there is NO CURRENT CURE).
As investors and shareholders this journey is not for the faint hearted. But first and foremost this journey is not about us, it is about a path towards a medical breakthrough. My humble suggestion is that if you can drag yourselves away from watching the share price on a half-hourly basis, and focus on what the company is actually aiming to achieve, the rest (big pharma interest, deals, ROI etc etc etc) will all naturally follow. Not all is always as it seems with markets, but the fundamentals of the company and its clinical trial cannot be manipulated - they simply are what they are: very exciting indeed.
Good luck to all holders.
- RS
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