Arbutus Biopharma Corp (NASDAQ:ABUS) Q3 2018 Earnings Conference Call November 7, 2018 4:30 PM ET
Pam Murphy - IR
Mark Murray - President and CEO
Mike Sofia - CSO
David Hastings - CFO
Liisa Bayko - JMP Securities
Katherine Xu - William Blair
Keay Nakae - Chardan
Good day, ladies and gentlemen, and welcome to Arbutus Biopharma Corporation 2018 Third Quarter Financial Results and Corporate Update. [Operator Instructions] As a reminder this conference is being recorded.
I'd now like to introduce your host for today's conference. Ms. Pam Murphy, you may begin.
Thank you and good afternoon. Thank you all for joining us. With me today are Dr. Mark Murray, Arbutus' CEO; Dr. Mike Sofia, Arbutus' Chief Scientific Officer; David Hastings, Arbutus' Chief Financial Officer and, Koert VandenEnden, Arbutus' Chief Accounting Officer.
Before we begin, we'd like to remind you that some of the statements made during the call today, are forward-looking statements including statements regarding our expectations for proprietary HCV pipeline including clinical timelines and results for the lead compounds AB-506 and AB-729. Our expected cash runway and expected revenues from our current and potential licensing agreement. The forward-looking statements are subject to number of risk and uncertainties that may cause our actual results to differ materially including those described in our most recent Annual Report on 10-K and from time-to-time in our document filed with the SEC.
Any forward-looking statements that we make on this call are based on assumptions as of today and we undertake no obligation to update these statements as a result of new information or future events.
I'd now like to pass the call to Mark for his introductory remarks. Mark?
Thanks, Pam. And thank you to everyone for joining us on the call today. Our singular mission at Arbutus is to develop a cure for patients with chronic HBV. We believe this can best be achieved using an effective combination of complementary therapeutic agents administered for five nights treatment duration. To that end and we have developed a pipeline a proprietary therapeutic agents that target multiple aspects of the chronic HBV inception. The most important of which are HBV DNA replication, Hepatitis B surface antigen expression and immune reactivation.
We're confident that our broad proprietary pipeline of drug candidates will allow us to develop an effective combination therapy for HBV. We're now focused on two agents in our pipeline AB-506 and AB-729 which we believe in combination could deliver a meaningful events over the current standard of care. Today I'm pleased to report that we have advanced our second-generation capsid inhibitor 506 into HBV patients.
Mike will further describe this study in a few minutes. Although we have confirmed that our first generation LNP enabled RNAi agent 1467 can lower Hepatitis B surface engine in some patients we're now focused on our subcutaneously delivered second generation RNAi agent AB-729. This is a GalNAc conjugate which Mike will also discuss in a few minutes. We anticipate that these two agents AB-506 and AB-729 will comprise an effective clinical combination. Provided the clinical trials for AB-506 and AB-729 proceed as expected we anticipate initiating combination clinical trials with these two agents in the first half of 2020.
Now as most of you know, last month we announced our decision to delay initiation of a planned Phase 1 clinical trial of AB-452 based on emerging non-clinical safety findings. AB-452 is a new chemical entity acting via RNA destabilizing mechanism which targets Hepatitis B surface antigen expression and we believe is important that we take the time needed to further characterize the compound before deciding to initiate clinical studies. In a few minutes, Mike Sofia will discuss the steps we're taking to better understand these results. but I want to assure you, that we remain confident the RNA destabilizing mechanism represents a very relevant and important target and success here could be very meaningful for patients and for Arbutus and for that reason while we further characterize the AB-452 observations we're advancing backup compounds that utilize the same mechanism.
Before turning the call over to Mike, I think it's worth noting that the FDA recently issued guidance regarding the development and approval of new HBV therapies. This guidance is timely and helpful to Arbutus because it illustrates a path through approval for new HBV therapies. The guidance anticipates the use of combination therapy and outlines what is needed to demonstrate safety efficacy and durability of response. Also this quarter, our [indiscernible] a [indiscernible] approval of ONPATTRO an RNAi therapeutic they have developed for the treatment of hereditary ATTR amyloidosis. Arbutus is entitled to royalty on global sales of ONPATTRO for the LNP technology licensed Arbutus to Alnylam for this product.
We expect to receive our first royalty payment in the fourth quarter and this could also be precise source of non-dilutive capital for us. I'll now turn the call over to Mike Sofia.
Thanks Mark. As Mark said we're committed to developing a cure for chronic hepatitis B using an effective combination of therapeutic agents administered for a finite treatment duration. Our initial partner is focused on fully blocking HBV and DNA replication and reducing [indiscernible] eliminating surface antigens. To that end, we have identified a novel and very compelling target which very selectively destabilizes or degrade it's all HBV RNA's. And thus, as effects on many aspects of a virus lifecycle including DNA replication and surface antigen production.
We've also identified a series of molecules exemplified by AB-452 which are potent and highly selective for Hepatitis B virus these molecules when in the presence of the Hepatitis B virus [indiscernible] sequence shortened the viral RNA poly(NYSE:A) tail thereby making them susceptible for degradation. This target mechanism is novel and is very exciting. Success here could enable our ultimate aspiration to provide a more effective all oral regimen for Hepatitis B patients. Today I'm not going to comment further only AB-452 observations Mark mentioned other than to say that, we've initiated a series of studies designed to fully understand the effects we have observed including determining that the effects we've seen or species specific that is may not occur [indiscernible] and if they're AB-452 specific or mechanism based. These studies will require several months to complete and we will provide an update when we resolved these questions.
In the meantime, we're advancing a number of potent back up compounds with similar potent RNA destabilizing activity. At this time, it's difficult to predict when we will have a lead backup compound ready for IND enabling studies. I hope to be able to provide you with more details on the AB-452 as well as the backup program in the coming months. As part of our commitment to target as antigen reduction we've also developed a second generation RNAi agent that acts for a different mechanism than AB-452 that AB-729. AB-729 employees a single RNAi trigger which spans all over the ABV transcripts and reduces all of the viral antigens. Importantly AB-729 also employees our proprietary GalNAc parasite targeting technology which will allow for less frequent subcutaneous dosing.
We're currently carrying out IND enabling studies and expect to bring AB-729 into clinical development sometime in the second quarter of next year. As Mark mentioned we anticipated combining AB-729 with our capsid inhibitor AB-506 once these agents have completed their initial immunotherapy studies in patients. As Mark also mentioned AB-506 our second generation capsid inhibitor has progressed with healthy volunteer portion of the Phase IA, IB study and into HBV patients. This portion of a study is a 28-day dose escalation study which will include combinations with new therapy. We expect the results of these studies to be available in the second quarter of next year.
I would like to turn the call over to Dave.
Thanks Mike and good afternoon everybody. I'll start today by discussing the company's cash position and runway. Cash and cash used are more important financial metrics. At September 30, 2018 we had a cash and investments balance of $142 million compared to $155 million at June 30 and $139 million at December 31. Our cash used in operating activities during Q2 2018 was $13.2 million and on a year-to-date basis, our cash used in operating activities has been $50.8 million. We expect our total cash burn for 2018 to be within our previous guidance of $70 million consistent of approximately $65 million for ongoing operations in RND investment and $5 million for one-time cost related to the closure of the Burnaby facility.
And while we're not giving 2019 cash burn guidance yet, I can say that our current cash and investment balance should support us into 2020. The only other area I'd like to address today is a various non-cash adjustments included in this quarter. These adjustments include $14.8 million write down of the intangible asset related to our first generation capsid inhibitor AB-423 which we've decided to indefinitely defer developing due to the advancement of our next generation capsid inhibitor AB-506.
This write-down was partially offset by the related decrease in deferred taxes of $4.3 million and a reduction in our contingent consideration liability of $5.6 million and finally, we also recorded for the first time in Q3. Our share of losses and our equity invested in Genevant which was $2.8 million. So with that, I'll turn the call back to Mark.
Thanks Dave. As you heard we're in a strong financial position to proceed with advancing the pipeline in building our company. Over the past month we've made some important strategic additions to our team and our Board of Directors. Dr. Gaston Picchio has joined our executive team in the role of Chief Development Officer and we've appointed Dr. Bill Simmons are Chair of our Clinical Advisory Board where Bill will continue to contribute to Arbutus in this important role. We also announced the appointments of Myrtle Potter and Jim Meyers to our Board of Directors. I'm very pleased with these additions to our executive team in our board. Each of these individuals brings us significant expertise and experience in our sector.
Operator I'll turn it over to you for Q&A.
[Operator Instructions] and our first question comes from Liisa Bayko with JMP Securities. Please proceed.
I'm wondering if you could just maybe provide a little bit more detail on what you're learning about the RNAi program and it seems like if you're moving another compound forward, maybe it's something specific to that particular compound, is that the right to interpret that and when do you think maybe you can give us a little more clarity and the timing of back up. Thank you.
So Liisa, as I said we're focused now on the second generation RNAi product, 1467 as you know is very complicated protocol, complicated mode to administration patients and we think it will be very difficult to commercialize that compound. We're treating some patients and trying to learn something from that study and as we learn more we'll report that to you. Now with certain [indiscernible].
I think I misspoke, I meant RNAi destabilize. Sorry.
Well I'm sorry, so Mike why don't you take that on?
Sure, thanks Liisa. So the RNAi destabilizer right now it's a little premature to say anything about what we've learned. We're analyzing the data, we're doing experiments to really get a significant and deep understanding of the observations that we have. So it will as we said, it will be some months before we can sort of do all those studies and pull that data together to really give a clear understanding. From the backup compounds ,we still as we've always said, we have a big commitment to the antigen knock down field, we believe that's going to be a critical compound in all the HBV cure and so we have this sort of comprehensive strategy to address that and the RNAi destabilizer for us was a foray into the small molecule orally available all oral combination strategy and we still very firmly believe in the mechanism of this agent is very compelling, the data we had, the preclinical was very compelling to us and so we still have a very strong commitment to that and we still have a very active program in that area bringing forward new agents that we think will be able to provide differentiating profile to AB-452, but we still believe that it's possible, that AB-452 can move forward, but that will be determined based on all the study results that we come through.
Okay and when does - how will you make it with that? Will that be a press release or sort of in passing or how?
I don't think we've decided exactly how we're going to do that, but we have been fairly let's say open in presenting data in scientific meetings on what we believe is the mechanism of action of this and so we will find an appropriate mechanism to provide that information.
Thank you very much.
Thank you. And our next question comes from Katherine Xu with William Blair. Please proceed.
So with regards to the royalty streams from ONPATTRO. I'm just wondering what your kind of internal planning in terms of projection for that is and does it make sense to monetize that at some point. And also on 452, did the species let's say one species observation or specific issue did that happen to kind of high super human dose, would you be able to comment on that. And then is there a timeline for the backup compounds to move up. It will be good to have some details around that line. Thank you.
Well you want to take ONPATTRO first Dave.
Sure, yes Katherine we did see announced the revenue numbers today. There was really nothing on that call or presentation that lessens our confidence about that product and the potential to provide a reasonable source of non-dilutive capital for the company and so we'll look at all our options and decide what is best when that's available.
Katherine with respect to the 452 study, I think we're just in the position to talk about that any further until we really understand it. But as Mike said a moment ago, once we have complete understanding we'll present that information.
Okay, thank you. And our next question comes from Keay Nakae with Chardan. Please proceed.
Yes, thanks. 452. Do you at least have a working hypothesis of why you think you're still [indiscernible] effect that you [indiscernible]?
You know I think in any, to when you find any observations you generate a couple of hypothesis that around which you then develop experiments to investigate and see which of these hypothesis be, may lead to the answer. So we do have a couple of hypothesis that we're working on, it's too early to say which one is going to be the most relevant and that will be depending on, what the data from our studies tells us?
Okay and then in terms of the backup compound. How different are they in 452? I'm assuming they're also small molecules but any color you can provide on that would be helpful?
Well I mean you know, their backup compounds anytime one continues to do work in a field, you try to diversify the chemical matter that you're working on. I can't really say at this point in time. The characteristics of this molecules because it's an ongoing study.
Okay, that's all I have today.
Thank you. And our next question comes from Madhu Kumar with FBR. Please proceed.
Mayank, this is Mayank calling in for Madhu. Thanks for taking my question and congrats on the quarter. just a couple for me, I'm just thinking about AB-506 just broadly could you talk a little bit about how you see the positioning as the molecule would advance the other core inhibitors that there are and in the context of maybe a delivery median, if anything we would love just gradually on the HBV [indiscernible] oncore [ph] inhibitors or even RNAi [indiscernible].
And then secondly, I think you mentioned in your remarks about the FDA workshop that had happened recently. Could you give more color on, how you're thinking about the program [ph] and how anything if there is to talk about endpoints and developmental exam as you think about dosing potency of [indiscernible] molecule that you're thinking about of ramping. Thank you.
Mike, do you want to just comment a little bit on what your expectations for 506 are?
So I think we reported on preclinical data with 506, it looks competitive to all the other agents that are currently in clinical developments, so we have high hopes for that molecule. Its pan-genotypic it has its dual mechanism of action, it has a very nice PK profile pre-clinically it works against nuke resistant variance. So it has all the right characteristics. Obviously it's progressed very nicely through our IND enabling studies and to human subjects and we're into patients, so we clear the PK safety piece of the Phase I studies. So it's moving along very nicely as we said, we'll have data on patient data sometime a lot of part of first half of 2019.
On the ALSB I guess you're talking about what we expect to learn there, there are certainly a couple studies being reported on some capsid inhibitors at this point in time, it doesn't look like there's going to be anything earth shattering based on what we can say from the abstracts that we've seen, but we're anxious to sort of attend the meeting and see what everyone has to say about the appeal [ph]. On the FDA guidance, we were happy to see that the document that came out from the FDA, the direct guidance it certainly is, it provides us the appropriate guidance for us and we were happy to see their focus in one part on combination therapy and I believe that's going to be key as we've always believed it would be, it does provide us some guidance on endpoints, none of them surprising to us as far as viral endpoints. So we continue to study the documents. Obviously the FDA is looking for feedback on it and we'll see what ultimately comes out as a final document there.
Is there anything specific we could talk to, what you're looking for basically in the path that could give you at least an idea or understanding of what combination would look like or is that too early to say that?
I think it's too early to say, I mean, we firmly believe that you have to address the viral replication issue aggressively, so nuke in combination we believe with capsid inhibitor will help us do that and as antigen question has been addressed. I think that's generally accepted in the field and I think certainly the guidance and their comments about looking at antigens levels, is something that the FDA I believe is also looking at. So believe those two things are going to be critical for cure and I think our portfolio allows us to address those issues.
Great. Thank you.
Thank you and at this time. I'm showing no further questions in queue. I'd like to turn the call back over to Mark Murray for further remarks.
Thank you operator. As you heard today, we remained singularly focused on our mission to develop a cure for Hepatitis B. based on a combination of complementary agents, both AB-506 and AB-729 will yield clinical data next year and are on path to be used in an effective combination. We're well positioned scientifically and financially to meet this objective for patients and our stakeholders. We appreciate your participation in the call today and look forward to sharing updates on our progress with you in the months ahead. Operator, this concludes our call today.
Ladies and gentlemen, thank you for your participation in today's conference. This concludes the program. You may now disconnect. Everyone have a great day.