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Benitec Biopharma Inc. (BNTC)

Q3 2018 Earnings Call· Fri, Jun 1, 2018

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Transcript

Operator

Operator

Thank you for standing by and welcome to the Benitec Biopharma Quarterly Corporate Update Conference Call. If we make any forward-looking statements we know as that such statements involve risk and uncertainties relating to the difficulties in our plans to develop and commercialize our product candidates, the timing of the initiation and completion of preclinical and clinical trials, the timing of patient enrollment and dosing in clinical trials, the timing of expected regulatory filings, the clinical utility and potential attributes and benefits of ddRNAi and our products to candidates potential future out licenses and collaborations, our intellectual property position and the ability to procure it additional process of financing. All participants are in a listen-only mode. There will be a presentation followed by a question-and-answer session. [Operator Instructions] I would now like to turn the floor over to your first speaker today Mr. Greg West, CEO. Please go ahead, Mr. West.

Greg West

Analyst

Thank you and good morning everyone, and thank you for attending our quarterly briefing. I will give a short overview and will then hand over to David Suhy, our Chief Scientific Officer, as well as Georgina Kilfoil, who is our Chief Development Officer to provide a brief update on our science and programs. We expect today's call to take less than half an hour and I would point out that we recently completed and OPMD webinar, which I would encourage you to listen to. There was lot of valuable and detailed information provided in the webinar and we describe why we think this program can be successful. So I would encourage you to listen to that. As many of you know, Benitec is focused on building a broad scientific pipeline of innovative therapeutics by harnessing the power of our DNA-directed RNA interference technology, known as ddRNAi. This unique platform technology combines gene therapy and gene silencing to change treatment paradigms of human disease. We are translating our science into measurable clinical outcomes, which is successful in the clinic will have the potential to provide novel treatment options and hope to patients suffering from disease, as well as provide a significant value -- shareholder value for Benitec. Our current pipeline is focused on four therapeutic areas to drive shareholder value. We have transitioned from a platform-based company into a business-driven by product developments with assets in oncology, re-genetic disorders, retinal disorders and infectious disease. Our Phase II clinical study with our late oncology asset is now active and we hope to be enrolling our first patient soon. In addition, we anticipate having a unique silence and replace therapeutic designed to treat an orphan disease oculopharyngeal muscular dystrophy or OPMD entering the clinic early in 2019. And we have other programs targeting…

Georgina Kilfoil

Analyst

Thank you, Greg. Turning first to our oncology study with BB-401, this is a Phase 2 clinical study designed as an open-label study to explore the safety, tolerability and efficacy of BB-401 following intra-tumoral injections. BB-401 is intended to produce a single strand antisense RNA directed to inhibit the expression of the Epidermal Growth Factor Receptor or EGFR a protein when stimulated induces cell differentiation and proliferation and has been known to be significantly amplified in cancer cells. BB-401 will be administered into the target lesion once a week for up to eight weeks, in up to 30 patients with squamous cell carcinoma of the head and neck known as HNSCC. These are patients who are refractory to all standard therapies such as surgery, chemotherapy and immunotherapy. We continue to make good progress in starting up the study. Our first site Chris O'Brien Lifehouse is active and we hope to have other sites active and our first patient enrolled in the near future. In addition, we now have regulatory approval from the Ministry of Health in Russia and hope to have the Russian site active during the month of June. In total, we anticipate using five to eight clinical sites in Australia and Russia. The primary outcome of the trial will measure the size of the size of the lesion using techniques such as CT and MRI. A positive response from BB-401 treatment is thus to reduce the overall size of the tumor or completely ablate the lesion. Additionally, we’ll be looking at secondary endpoints such as progression free survival, overall survival, duration of response, disease control rate, safety and tolerability. In addition, we will be monitoring molecular markers and biobsolete lesions to monitor the presence of BB-401and the antisense RNA produced from the vector as well as the result…

David Suhy

Analyst

Thanks, Georgiana. We’ve talked about in past calls of conducting our IND enabling toxicology studies in sheep. And just as a reminder, the reason we selected this species is that the weight of the animal and the size of the key muscles in the upper digestive system are relatively consistent with human subjects. These key features are really key to using this model to support the lot of administration of a direct injection into the cricopharyngeal muscle, as well as in the surrounding muscles. We are nearing the endpoint of an initial study, which has involved 19 sheep. Although the in life portion of this initial study is not totally complete, we have not observed any abnormal safety signal in the sheep dose to-date with the BB-301 compound. Molecular analyses of these tissues will include histology, as well as biodistribution studies to study the expressions of B shRNA as well as the codon-optimized PABPN1 protein as related to the levels of BB-301 that we administered to the throat muscles. In addition, we are well positioned to initiate an expanded animal study in 54 sheep as a definitive regulatory and toxicology studies to support entry of BB-301 into the clinic. The in life portion for the reg tox studies will take approximately 90 days for each animal, once each animal has been treated with single doses of the drug. Specifically, these studies are geared to identify any significant adverse related events to BB-301 dosing. That study will commence in mid-summer in a few months time. Lastly, to support any human clinical trial towards clinical development, you need to have ability to produce the drug in sufficient quantities. For BB-301, we produce the material in a baculovirus-based system which is a suspension manufacturing system that allows for the manufacturer of viral-based products…

Greg West

Analyst

Yes, thank you, David, and thank you, Georgiana. The continued steady progress we make with both the oncology program and the OPMD program will be the major catalysts for value creation and news flow in 2018. We believe that Benitec is uniquely positioned to develop therapeutic compounds with novel product profiles, coupled with a potential superior clinical activity in each of these disease areas. The milestones we have achieved over this previous quarter speak to our strategy of becoming a multi-product clinical stage company and represent an opportunity for shareholder value. I’ll now ask the operator for questions.

Operator

Operator

[Operator Instructions] There are no questions. I will now hand back to Mr. West for closing remarks.

Greg West

Analyst

What -- we have one or two questions that came through from our shareholders late yesterday. So, want to just refer to a couple of those. And Georgiana, do you want to?

Georgina Kilfoil

Analyst

Sure. The first question relates to the silence and replace approach. The question is, in talking about the silence and replace approach in other areas, can you expand n what you mean by this?

Greg West

Analyst

David, do you want to talk to that?

David Suhy

Analyst

Yes, so I think one of the unique features of the Benitec technology in terms of treating molecular-based diseases is the fact that we use a mechanism of silencing called RNA interference. Most typically, these involve the short synthesis or the synthesis of short RNA strands to knock down specific target genes. In traditional gene therapy, you either replace proteins or you use technologies potentially such as genome editing, to be able to silence genes in the latter case. With genome editing-based techniques often times you have to knock in large proteins to be able to impact or have that mechanism of action actually occur, and so, most of the times that vector is filled up by the presence of this large protein. Because RNA interference uses endogenous silent machinery in a short hairpin RNA that we produce take up so very little of that packaging capacity, we have the capability of doing other things with the excess space in these viral vectors. In the case of BB-301, this means, we could use the short hairpin RNA to silence disease-causing genes, but in the same therapeutic vector express the form the best in protein. And so this is really quite to RNA interference technology delivered by gene therapy mechanisms. The ability to have a single vector system you need to only have to produce and manufacture one vector to be able to both silent disease-causing genes and replace them with healthy wild-type copies. At Benitec, we’ve been looking to see how to expand into other potential pipeline programs which may have the ability to use the same silence and replace based technology. Again, we think that this is a feature which is unique to our technology and we look to capitalize on the ability to use this unique feature to stretch into other disease indications and you should probably be looking to hear about some of that at some point in the future.

Greg West

Analyst

Thank you, David. Georgiana there are a couple of other shareholder questions, but one on BB-301?

Georgina Kilfoil

Analyst

Yes, we do have one additional question, which is what will it take to get BB-301 to the market? And I am happy to talk a little bit about that one. BB-301 is a gene therapy and OPMD is an orphan disease with no current treatment available. So we don’t anticipate that we’ll have to take it through a traditional Phase 1, Phase 2, Phase 3 approach. What -- in our meetings that I described earlier with the regulatory agencies, what we’ve been talking about is that, assuming no safety signals are seen in the first clinical study and that we see a pretty good indication of clinical efficacy. We would hopefully be moving from that study straight into a small Phase 3 study to support approval of BB-301. Obviously, if there is something on what’s seen or we don’t find an effective dose, we would need to do more studies and likewise if we see really, really good efficacy, we would certainly be having discussions with the regulatory agencies about progressing even faster to the market. So, at the end of the day, it’s going to depend on the outcomes from that first study. But as I said before, we are working to design that study in a way to maximize our opportunities to success. I’ll pass back to Greg to wrap up.

Greg West

Analyst

Thank you. In closing, I would encourage you to go back and listen to our OPMD webinar that was new material included in that presentation. And a lot of valuable and detailed information, and in particular it does describe why we think the program will be successful. I would also just like to say that the efforts and strategies of recent years are now delivering with our oncology program in the clinic and the orphan program progressing towards the clinic. We are hopeful that this transition to becoming a clinical-stage company once again will result in significant patient benefit and shareholder value for Benitec. Thank you to all our participants today and especially that our shareholders and analysts who contributed and listen to our earnings report. And thank all investors for their continued support. Thank you, operator.

Operator

Operator

That does conclude our conference for today. Thank you for participating. You may now disconnect.