Adam Cutler - Senior Vice President, Corporate Affairs Mark Murray - President and Chief Executive Officer Bruce Cousins - Executive Vice President and Chief Financial Officer.
John Chung - RBC Capital Markets Dana Yi - Nomura Securities Prakhar Verma - Stifel, Nicolaus & Co., Inc. David Novak - Clarus Securities Jonathan Chang - Leerink Partners LLC David Martin - Bloom Burton & Co..
Good day, ladies and gentlemen. And welcome to the Tekmira Corporate Update and First Quarter Results Conference Call. At this time, all participants are in a listen-only mode. Later, we will conduct a question-and-answer session and instructions will follow at that time. [Operator Instructions] As a reminder, today’s conference call is being recorded.
I would now like to turn the conference over to Adam Cutler, Senior Vice President, Corporate Affairs. Please go ahead..
Good afternoon and thank you for joining us, as we provide a corporate update and report first quarter 2015 financial results for Tekmira Pharmaceuticals Corporation. Speaking on today’s call are Dr. Mark Murray, Tekmira’s CEO; and Bruce Cousins, CFO.
Mark will provide a corporate update and Bruce will review the company’s first quarter 2015 financials and future outlook. Following our prepared remarks, there will be a Q&A session.
I’d like to remind everyone that certain statements made on today’s call will be forward-looking and constitute forward-looking statements or forward-looking information under applicable securities laws.
Forward-looking statements and information discussed in this conference call include but are not limited to, building an HBV solutions company, realizing the value of our non-HBV assets, 2015 clinical milestones for HBV pipeline, expected runway from our cash and investment balance, and expected cash burn for 2015.
Forward-looking statements and information are current predictions only, which are based on certain assumptions, which include, but are not limited to, the effectiveness of our products and trials, continued regulatory approval, and the stability of economic and market conditions.
While we consider these assumptions to be reasonable, these assumptions are inherently subject to significant business, economic, competitive market, and social uncertainties and contingencies.
Forward-looking statements and information involve known and unknown risks, uncertainties and other factors that may cause the actual results to be materially different from any future results expressed or implied by such forward-looking statements.
A more complete discussion of the risks and uncertainties facing Tekmira appears in Tekmira’s 10-K for the year-ended December 31, 2014, which is filed on EDGAR and SEDAR and is available online under the Investors section of our website. We do not expect to update forward-looking statements continually as conditions change.
This conference call is being webcast live and the archive will be available on our website at www.tekmira.com following today’s call. Please note that we report in U.S. dollars and in compliance with U.S. GAAP. At the end of the prepared comments, we will open the call up for questions. So now, over to Mark..
Good afternoon, and thank you joining us on the call and webcast today. I would like to focus my remarks on recent corporate highlights and upcoming pipeline milestones.
We remain as excited as ever about the prospects for Tekmira, based on our strategy to build the HBV solutions company, as well our determination to realize the value of our non-HBV assets. Since our year-end financial results conference call we have been pleased to announce multiple positive developments for the company.
On the general corporate front, we completed the merger with OnCore on March 4, and we are working extremely well as a combined team.
On March 25, we completed an underwritten equity financing that generated gross proceeds of $152 million, this was an important event for the company as it extended our runway well into 2018 and brought investment from high quality new and existing institutional shareholders.
We thank our investors for your trust and support, and we are committed to putting your capital to good use in executing on our HBV strategy and generating value for all of our shareholders. Some of the Tekmira team recently attended the International Liver Conference, also referred to as EASL in Vienna.
Our team was able to interact with many of the top HBV clinicians and researchers from around the world. And we were very pleased by the level of enthusiasm and support that these key opinion leaders had for the Tekmira strategy and pipeline.
They echoed our sentiment about the need for new regimens to enable cures for chronically infected HBV patients, as well as the need for combination therapy to address the various aspects of HBV viral infections. I would now like to review some of the recent company highlights. These include positive preclinical data on two of our product candidates.
The first was TKM-Ebola-Guinea, which demonstrated 100% survival of nonhuman primates infected with the West Africa Makona strain of the Ebola virus, previously referred to as the Guinea strain. These results were published in Nature in April and were presented at the 7th International Symposium of Filoviruses in Washington DC.
The second was, TKM-HTG for the treatment of severe hypertriglyceridemia. The results demonstrated super-additive effects on plasma triglyceride lowering by silencing both ApoC3 and ANGPTL3. These data were presented at the Keystone Symposia Conference on Liver Metabolism and Nonalcoholic Fatty Liver Diseases.
We were also pleased to report that the FDA recently modified partial clinical hold on our Investigational New Drug Application for TKM-Ebola to allow repeat dosing of healthy volunteers in our Phase I study.
And lastly our partner, Alnylam, announced on April 21 positive 12-month clinical data from the ongoing Phase 2 open-label extension study with LNP-enabled patisiran in patients with familial amyloidotic polyneuropathy.
Importantly, the results demonstrate that multi-dosing using our LNP technology has been well-tolerated with treatments out to 17 months. We believe that these recent announcements highlight the utility of our LNP technology and the potential of some of our non-HBV pipeline.
However, our primary focus going forward remains our HBV product pipeline, which we are working diligently to advance. We expect to be able to announce the following milestones for our HBV pipeline by the end of 2015. For TKM-HBV, our trial assessing the safety, tolerability and pharmacokinetics is ongoing in healthy subjects.
Phase 1 results in selection of an LNP formulation to advance into a multi-dosing trial, is expected in the second-half of 2015. For OCB-030 our cyclophilin inhibitor, preclinical studies are ongoing with an expected IND or equivalent filing planned for the end of 2015.
For CYT-003 our TLR 9 agonist, initiation of preclinical studies is anticipated in the first-half of 2015. Pending positive clinical results we expect to advance CYT-003 into clinical studies leveraging using the existing safety database already cumulated in prior various studies and open INDs.
Now, I’d like to ask Bruce to discuss our financial performance..
Thanks, Mark. I’ll begin by noting that as at the end of Q1 2015 we had a cash balance of $232.3 million. On March 15 - sorry, in March 2015, we completed a U.S. share offering which provided us with $142.2 million in net proceeds. We will use this funding to develop and advance our products through clinical trials and for general corporate purposes.
Our goal in undertaking this financing was to fund the company through delivery of Phase 2 combination data in HBV. Now turning to the financial highlights for Q1, effective March 4, our financial results are consolidated with the results of OnCore BioPharma, now represented as a wholly-owned subsidiary of Tekmira Pharmaceuticals.
Our net loss for Q1 2015 was $12 million as compared to a net loss of $18 million for Q1 2014.
This significant improvement in net loss includes $9.3 million of acquisition costs related to the merger increased operating expenses of approximately $3 million, offset by increased foreign exchange gains of $5.6 million and a decrease in fair - in warrant fair value adjustment of $12.4 million.
Looking at revenue, in Q1 2015 revenue was $4.7 million as compared to $4.4 million in Q1 2014. Most of our revenue this quarter is from our U.S. Department of Defense contract to develop TKM-Ebola and manufacture TKM-Ebola-Guinea for use in West Africa.
Under the contract we are being reimbursed for costs incurred and we earn an incentive fee or profit margin on this. In Q1 2015, we also recognized $1.1 million in revenue from our contract with Monsanto, and $0.5 dollars from our development and supply agreement with Dicerna Pharmaceuticals.
Dicerna is using our delivery technology in combination with their proprietary payload technology to develop a treatment for primary hyperoxaluria. Now, turning now to expenses, total research, development, collaborations and contracts expenses increased to $10.6 million for Q1 2015 from $8.2 million in Q1 2014.
This increase relates to the progress of our product candidates including initiation of a Phase 1 clinical trial for TKM-HBV, and the purchase of materials for the manufacture of TKM-Ebola-Guinea.
In addition to operational activities, we recorded non-cash compensation expense of $1.2 million related to the expiry of repurchase rights on shares issued as part of the consideration paid in the merger. The repurchase rights relate to OnCore founder shares which are subject to repurchase agreements.
The post-merger fair value of these shares of $57 million is expected to be recognized as compensation expense over the period of expiry of the rights. This item is further detailed in note three of our financial statements.
Excluding this $1.2 million charge in the quarter, would result in a non-GAAP net loss of $10.8 million and it represents further improvement compared to our GAAP net loss of $12 million.
Because the $1.2 million is a non-cash charge, isolated to the merger with OnCore, we believe excluding this item provides supplementary measures of performance to better reflect the economics of Tekmira’s business.
As at the end of March 2015, we had total outstanding shares of 54.1 million, which includes the 24 million common shares issued with the merger with OnCore. And 7.5 million common shares issued with our financing in March. Our total outstanding shares on a fully diluted basis is 57 million. Now, I will ask the operator to open the call for questions..
[Operator Instructions] And our first question comes from Michael Yee of RBC Capital Markets. Your line is now open..
Hi, thanks. This is John Chung on behalf of Michael Yee. Congrats on the progress so far. So with the merger with OnCore, you now have an extensive pipeline of multiple HBV assets.
So my question is on at which point do you think we will start to see these drugs put into combination and data emerge? Any color on when needs to be first completed and how long each step would take? That would be helpful. Thanks.
John, this is Mark. So I think first of all, we have to get these agents into the clinic. And typically, what we expect to do is take an agent, for example, OCB-030 into a Phase 1 safety study to demonstrate the product is safe.
And then into a patient study, where we look at the primary activity of the drug alone, and then we will be starting to combine that. So if you look at our forecast for TKM-HBV, we expect to be in chronically infected patients by the end of this year.
So then we will understand its primary activity in the following year and OCB-030 will be on its heal. So I think roughly speaking, we are imagining that towards the end of 2017, we should be in a position to start combining agents. And they will follow on in a similar fashion..
Right. Right. Then for now just focusing on the TKM-HBV, can you provide on color - any color on how you are thinking about the design at the next multi-ascending dose trial, you mentioned that it will likely be in HBV patients.
But what about the design in terms of - would the arms - would it likely be stacked in parallel or stacked in sequence one off each does? Thanks..
I’m not sure. So, we are planning for that study to be a multi-dosing study in chronically infected patients and it will likely involved in limited dose-escalation scheme..
Thank you. And our next question comes from Ian Somaiya of Nomura Securities. Your line is now open..
Hi, this is Dana for Ian. I have one quick question on something broad.
What kind of discussions did you have with KOLs at EASL and if you could discuss your main take-away from the conference?.
Well, I think, we have been speaking with KOLs for quite some time. And they know - they know the company and they know a number of the management in the company. I think the key take on message was that, they are very excited about the idea that combinations can be developed in one organization like we have the ability to do.
They’re very interested in the - obviously, the combination strategy as well as the various mechanisms of action, which we are pursuing. So we’ve got a lot of very positive feedback that we are on the right track..
Thank you. And our next question comes from Stephen Willey of Stifel. Your line is now open..
Hi. This is Prakhar on for Steve today. Thank you for taking my question. At your R&D Day last year, you talked about doing a single dose study, maybe in a country like in Eastern Europe or Asia, where authorities may permit clinical testing in infected subjects without any healthy subject data.
Do you have any update on that?.
So I think we are - we have sort of passed that buy. We are already in healthy subjects and we will be going in a multi-dosing study into chronically infected patients later this year..
Okay. Thank you..
Thank you. And our next question comes from David Novak of Clarus Securities. Your line is now open. Please check your mute button, Mr. Novak..
Good afternoon. Sorry about that. Thanks for taking the call. Just a couple of questions for you guys, specifically related to TKM-Ebola, as I’m obviously interested in that asset and the potential priority you view the antigen, how that could be used for other things that you are doing in your pipeline right now.
So is there any update that you can give us with respect to the trial in Port Loko, how many patients have been enrolled difficulties that you’re potentially facing? And can you remind me, are you using the lyophilized version out there or the wet version?.
David, this is Mark. So that’s, first of all, it’s the new product which has been adopted to the Guinea strain or the Makona strain now, name change. We’re using the wet form, not the lyophilized form. We have not disclosed how many patients had been treated yet.
With respect to challenges, I would point to the fact that the outbreak seems to be limiting itself and there are fewer patients available..
Gotcha.
Can we get a little clarity into why the company has chosen direct resources towards resumption of the original TKM-Ebola trial, the FDA registered Phase I?.
Well. So first of all you know, that this is a collaboration we have with the U.S. Department of Defense, all of our activity here is funded. We think this is an opportunity to measure pharmacokinetics in healthy individuals, which can help us to inform things like the studies that are going on in Western Africa..
Gotcha.
And I haven’t had a chance yet to review the nature of manuscript, but what was the Makona viral load in terms of platforming that the nonhuman primates were remarkingly did with?.
Yes, I don’t know that off the top of my head, you have to look at the paper, several lethal-fold..
Okay. And finally, Bruce, on the last call you suggested that you might be able to give us a little guidance with respect to R&D expense going forward with all that clinical trials being initiated.
Do you have anything to say with respect to that today, I have R&D coming in at about $54 million for 2015 year-end, is that reasonable higher or lower, any guidance would be appreciated?.
David, I’ll offer you some higher-level guidance in terms of cash burn for the year and when we expect to be in the zone of $60 million to $70 million. And frankly, my expectations are to be at the bottom end of that range..
Helpful. Thank you very much. That’s it from me, and thanks again for taking the call..
Thanks, David..
Thank you. And our next question comes from Michael Schmidt of Leerink Partners. Your line is now open..
Hi, it’s Jonathan Chang stepping in for Michael Schmidt. Thanks for taking my questions. I have two.
So the first one, as you work towards deciding the various potential HBV combinations you could test, I’m wondering if there’s anything at EASL maybe from your conversations with KOLs that changed or confirmed your thinking in terms of asset prioritization?.
No, I don’t think so. We’re trying to keep a very open mind and not bias ourselves..
Okay.
And maybe second question, do you have any guidance in terms of when we can expect to see preclinical data from the former OnCore assets?.
So that’s actively being worked on now. And so, I think, we’re very committed to release data as it becomes available, but I don’t have a specific target for you..
Okay. Thanks..
Thank you. [Operator Instructions] And our next question comes from David Martin of Bloom Burton. Your line is now open..
Hi, guys, thanks for taking my question. It kind of follows up on the last question. And so OCB-030, I think OnCore’s website before you bought them had indicated that it was differentiated versus other cyclophilin inhibitors.
And I I’m just wondering out what level is that differentiated if you can expand on that?.
David, it’s a very different molecular structure than the other cyclosporine like molecules..
Okay.
They said, it had a different preclinical profile, and I’m wondering what that meant?.
I don’t think I’m in a position to tell you all the preclinical data at the moment. These are experiments that are ongoing….
Okay..
And I think we are going to be in a position to compare it to the other types of cyclophilin inhibitors as well..
Okay. So the second question goes to the other siRNA assets, the non-HBV assets. I’m wondering have you got plans for what comes beyond the next immediate milestones that you’ve laid out, I’m thinking in particular PLK-1, but you have a lot of data for now.
Would you move it to the next level of testing beyond the Phase 1, 2s by yourself, or would you need a partner to step up, do you feel?.
Well, I think, again, this will be - depend a little bit on the data that is produced. But I think given that we are trying to spend is all of our resources in HBV, I think PLK is an agent that we are more likely to explore with a partner..
Okay. Okay, so I guess we’ll wait and see the data and figure it out at that point..
Yes..
Okay. Thank you..
Thank you. And I’m showing no further questions at this time. I would like to turn the conference back over to Mr. Adam Cutler for any closing remarks..
Thank you, operator. We appreciate everyone’s participation in the call today, and we look forward to sharing updates on our progress view in the months ahead. This concludes our call for today. Thank you very much..
Ladies and gentlemen, thank you for participating in today’s conference. This does conclude the program and you may all disconnect. Have a great day, everyone..