Earnings Labs

Lineage Cell Therapeutics, Inc. (LCTX)

Q2 2019 Earnings Call· Thu, Aug 8, 2019

$1.57

+0.97%

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Transcript

Operator

Operator

Welcome to the BioTime, Inc. Second Quarter 2019 Conference Call. At this time, all participants are in a listen-only mode. An audio webcast of this call is available on the Investors section of BioTime’s website at www.biotimeinc.com. This call is subject to copyright and is the property of BioTime and recordings, reproduction and transmission of this call without the expressed written consent of BioTime are strictly prohibited. As a reminder, today’s call is being recorded. I would now like to introduce your host for today’s conference, Ioana Hone, Director of Investor Relations at BioTime. Ms. Hone, you may begin.

Ioana Hone

Management

Thank you, Chris. Good afternoon and thank you for joining us. A press release reporting our second quarter 2019 financial results was issued earlier today August 8, 2019 and can be found on the Investors section of our website. Please note that today’s conference call and webcast will contain forward-looking statements within the meaning of federal securities laws, including statements regarding our strategy, goals, product candidates and clinical trials, expected synergies and benefits of the Asterias acquisition and financing matters. Such statements are subject to significant risks and uncertainties, including those described in our press release issued on August 8, 2019 and our recent SEC filings on Form 8-K, Form 10-K and Form 10-Q. Actual results or performance may differ materially from the expectations indicated by our forward-looking statements due to those risks and uncertainties. We caution you not to place undue reliance on any of the forward-looking statements, which speak only as of today. Joining us today are our Chief Executive Officer, Brian Culley; our Chief Financial Officer, Brandi Roberts and our Chief Medical Officer, Ed Wirth who is joining us telephonically from our manufacturing facility in Israel, where he is overseeing the final steps of the tech transfer of OPC1 to our facilities. The executives will provide prepared remarks then take questions from analysts and institutional holders. With that, I would like to turn the call over to Brian Culley, our CEO.

Brian Culley

Management

Thank you, Ioana and good afternoon everyone. As most of you know on my first quarterly call last year, I outlined our plan to reposition BioTime as an undisputable leader in the field of cell therapy. That meant reducing the complexity of our business, particularly of our affiliate companies and focusing on our clinical stage pipeline. In connection with this plan, we also made a large number of changes to our management team, including hiring a new Chief Financial Officer, Chief Medical Officer, General Counsel and just this week a new Vice President of Business Development. We are also relocating our corporate headquarters to Carlsbad, California just north of San Diego. With these changes to our structure and team now in place, we felt the company was so profoundly different from 1 year ago, that is also what makes sense to update our name. We chose Lineage Cell Therapeutics, because it only does a better job of describing what we do, but also gives investors and other important audiences a reason to take a fresh look at our business. We further elected to relocate our office and management functions to Carlsbad, but we plan to retain our R&D space in the Bay Area and our GMP manufacturing facility in Israel. You can read more about the reasons for the name change and the relocation in a letter to shareholders which I provided last week and which is available on our website. Please also note that in connection with the name change, trading under our new ticker, LCTX or Lima, Charlie, Tango, X-ray, will be effective as of Monday, August 12, 2019. With these organizational steps largely complete, these quarterly calls will increasingly focus on the progress we make with our therapeutic assets and of course our financials. We believe that…

Brandi Roberts

Management

Thank you, Brian. I would like to start the financial discussion and update on our cash position. We ended the second quarter with $16.7 million in cash, cash equivalents and marketable securities. In early July, we converted about 15% of our OncoCyte Holdings for growth proceeds of $4.5 million. Also in July, we sold about 647,000 shares of our Hadasit Holdings for gross proceeds of $1.2 million. I am also happy to report that just today we received proceeds of approximately $2 million in our OpRegen grant funding from the IIA. The transactions involving OncoCyte and Hadasit are part of an intentional strategy to raise operating capital for BioTime through sources other than BioTime common stock and where it makes sense to do so we will continue to leverage our equity investments or the $21.6 million phase value promissory note due to us next August from Juvenescence to further support our business. We believe that OncoCyte, Hadasit and AgeX have promising technologies, but it’s important to balance that promise with the need to advance our internal program. It is also important to note that in parallel we will continue to asses other funding and strategic alliance opportunities, which maybe available through our existing or future potential partners. I would also like to note that we may raise capital in small amounts from quarter-to-quarter. We don’t necessarily believe that we need to have 1 to 2 years of cash on hand like many other biotech companies, because we have these investments that we can leverage as necessary. We are also actively working on cost reductions. As Brian mentioned, we were able to just about absorb the activities Asterias into existing Bio Time employees’ responsibilities. We were also able to further reduce headcount by realigning priorities and ensuring focus on our clinical…

Brian Culley

Management

Thanks, Brandi. It’s been almost 1 year since I joined the company. I am glad to have largely completed the process of simplifying the business and redefining our brand. I think we now have the right pieces in place to achieve our goals and we have a number of additional steps planned, which are intended to improve our visibility in the investor community and ensure our work is being noticed. I also want to add that cell therapy is becoming a mainstream technology. The subcategories of CAR-T and gene therapy have already enjoyed in explosion of growth and we think that our area of cell therapy specifically transplanting differentiated cells into the body to replace lost function also will grow exponentially in the coming years. As we saw that happen years ago with a sudden and tremendous interest in developing drugs for orphan diseases and we think deals like the $600 million transaction that was announced this morning between Bayer and Blue Rock are just the tip of the iceberg for cell therapy. To be ready for this growth, we will focus on further collection and maturation of our OpRegen data in dry AMD improving the manufacturing of OPC1 cells in the consistent scalable manner and determining whether VAC2 in genders and immune response in cancer patients. Each of which are key advancements for our business expected to happen in the second half of this year and into the beginning of next year. Specifically, three clinical milestones our investors can look forward to this year include completing patient enrollment in the United States in the Orbit STS portion of the ongoing Phase 1/2a clinical study of OpRegen for the treatment of dry AMD, presenting new OpRegen data from the ongoing Phase 1/2a clinical study at the 2019 American Academy of Ophthalmology Annual Meeting in October and announcing a decision on BioTime CE Mark application for Renevia. Lastly, we look forward to launching this new corporate brand website and social media presents next week as Lineage Cell Therapeutics. Thank you very much for listening today. And with that operator the team is ready for any questions.

Operator

Operator

Thank you. [Operator Instructions] And our first question comes from the line of Kevin DeGeeter with Oppenheimer. Your line is now open.

Kevin DeGeeter

Analyst

Hi, thanks for taking my questions guys and congratulations on really tremendous amount of progress here. Brian, can you just comment as to how we should frame expectations with regard to data presentation, should we look for clinical data from newly dosed patients, including those with the new device or should we anticipate this being mostly longer term follow-up on patients dosed into earlier cohorts?

Brian Culley

Management

Yes, Kevin, I think the answer is you will get some of both. So certainly it’s important to see a maturation of the original set of patients that were dosed seeing how someone’s area of geographic atrophy or even their visual acuity, how that performs at 12 months versus 3 months. I think 12 months is much more interesting. So for the patients or the subjects who have already been treated being an aging or maturation of that data to maybe get a sense for how long the benefit sticks around, I think that’s part of what you should look for. And then the other part is it maybe even more important which is how are the administrations with the new device going, is it living up to expectations, the expectations are high, but the first subject as a standalone piece of evidence seems extremely encouraging where there is a lot of risk going into the new device for the first time, but everything seemed to have gone well. So you can expect in October that there will be additional Orbit subjects that you will be able to have let’s say AE information on or hopefully lack of AE rather and then you also see an aging or maturation of the initial subjects. And so you will get a little bit of each.

Kevin DeGeeter

Analyst

Terrific. Now, that’s very helpful. And then just secondly then I will get back into queue, you did point out the highlight the addition of a new member of the team, the Head of Business Development, can you just comment your current priorities with regard to business development and how one thinks about that in terms of breakdown by geography versus certain products for example OpRegen versus others?

Brian Culley

Management

Of course, I think first and foremost what business development does for an organization is provide optionality partnerships principally bring one of two things or a combination and that is money and capabilities. And so if you are actively out there having conversations making sure you have got options on the table to be able to enter into an agreement that it makes sense to do so or not enter into an agreement if it’s not beneficial for your company, so that the top level strategy is really about optionality. The next level strategy gets into things like regional partnerships versus global partnerships, frontloading, back-loading economics that gets into a level of detail that we won’t cover on this call, but I do think that adding an experienced business development Vice President will be helpful for getting us some greater awareness and bring some options to us that we might not have had over the last few months.

Kevin DeGeeter

Analyst

Well, congratulations again on the progress.

Brian Culley

Management

I appreciate that, Kevin. Thank you.

Operator

Operator

Thank you. And our next question comes from the line of Jason McCarthy with Maxim Group. Your line is now open.

Jason McCarthy

Analyst · Maxim Group. Your line is now open.

Hi, Brian. Two questions. I just want to touch on the Orbit device and the cohort 4 first assuming that all goes well you get the first patient in no safety issues and you move up to the 6 patients. We still have to wait some time to start to see the [indiscernible] data and other measures, would you consider either expanding to more patients in that fourth cohort or would you look to start another second study of Phase 2 study almost in parallel before we see the data from those last 6 or 7 patients in the Phase 1/2a?

Brian Culley

Management

Yes, hi, Jason. It’s a good question and we can’t say definitively what the answer will be right now. When we entered into the agreement with Orbit, we said okay, we agreed with them, we will look at 6 patients. When we introduced Orbit into the trial there were 9 subjects left to be enrolled though I can’t even promise you that we will do the last three without Orbit, with Orbit or at all. So I think what we want to do, because we have a new device, it’s a relatively small number is just collect the data and see how it’s looking for us. If there is a strong argument to expand enrollment in the current study and the current protocol we are of course going to consider that, but if the counter argument is that we have learned what we needed to learn and we are ready to go into a larger and differently designed study, we will be very excited about doing that, because that presumably means that things have gone well. So we need to collect the data before we can make the decision, but we do want to keep the flexibility of collecting additional data if needed as something that is on the table. But the current plan is 6 subjects with Orbit and they will have to make a decision as to the final 3. And if the data look good we would want to close the study and start a new larger study thereafter either alone or to bring Kevin’s point back in potentially what they partner on board.

Jason McCarthy

Analyst · Maxim Group. Your line is now open.

Got it. And just the second question with all the focus on spinal cord and AMD, you did mention VAC2 and you could see potentially some early data showing immunogenicity, in which case you would consider possibly doing a combination trial with the checkpoint, given that it is a cell-based vaccine, I am not sure if there is cryopreservation involved that could save cost, but it looks like a trial that could be rather costly, would you seek a partner or would you look to expand Bio Time or Lineage’s role in oncology?

Brian Culley

Management

Yes. So as you know we do have a really nice partnership with Cancer Research UK for the current protocol. If one thing that we have said that we would like to do is talk to Cancer Research UK to find out if it makes sense for us to continue and expand that involvement into a different protocol that I think would include checkpoint in combination or perhaps some other design. One of the things that we are going through right now is to find out where we can best operate in that space. So I don’t think that non-small cell lung cancer is necessarily the best place for this technology today, there are probably better places that we might have a chance of succeeding not due to any one specific characteristic, but rather to the overall constellation of where checkpoint inhibitors are used, how the competitive landscape looks like and so forth. So it’s true that we haven’t said historically a whole lot about the VAC2, but we are increasingly encouraged by the idea that educating T-cells the way that we do it and using not an autologous source, which you will recall from some other companies, it can be extremely expensive and onerous from an operational and handling standpoint, but rather having an off-the-shelf solution of dendritic cells loaded with an antigen that can prime the T-cells to in gender response and then using the checkpoint inhibitor to basically make that respond from that amplification premises. We think that, that’s probably the best probability of success. And so the first place we would start is with our existing partner and if you are not interested or not willing, then we of course would go to a table of other ideas that we have which of course can include continuing on our own. So we still probably have quite a number of months before the current study is completed, but we definitely want to find out as soon as we are practically possible and prepared to do so, what the bright next clinical study with VAC2 should look like.

Jason McCarthy

Analyst · Maxim Group. Your line is now open.

Got it. Thanks so much for taking the questions.

Brian Culley

Management

Thank you, Jason.

Operator

Operator

Thank you. And our next question comes from the line of Joseph Pantginis with H.C. Wainwright. Your line is now open.

Unidentified Analyst

Analyst · H.C. Wainwright. Your line is now open.

Hi guys. This is [indiscernible] line of Joe. Can you hear me okay?

Brian Culley

Management

Yes.

Unidentified Analyst

Analyst · H.C. Wainwright. Your line is now open.

How are you?

Brian Culley

Management

Very well.

Unidentified Analyst

Analyst · H.C. Wainwright. Your line is now open.

Okay. Few questions for me. First of all, thank you for taking my question. So for the Orbit device, how do you view the uptake and sufficient interest of the Orbit device and can you remind us about the logistic of any special training before patient treatment?

Brian Culley

Management

Yes, certainly, the Orbit device in light of the fact that it received it’s 510k clearance just last November is largely unfamiliar to surgeons. So there is a training procedure that they go through. It’s about a half day training procedure that could be on the back of the eyes or it could be on a large mammal eye. That training is pretty straight forward. The response to that training and the first experiences that physicians have had with the device has been overwhelmingly favorable. The physician who did the first procedure in the human setting was very happy that it performed exactly as it did in training and others who have been trained whether part of our study or whether part of the work that was done by Orbit in the past has been very favorable. So we think that eventually this is going to become the standard of care to deliver cells to the back of the eye. We just happen to be the pioneers of it, but all of the evidence that we have today would suggest to us that this will be the way of the future.

Unidentified Analyst

Analyst · H.C. Wainwright. Your line is now open.

Alright, pretty good. Another question for me please. Can you tell us where you are in complying all the OPC data now that this is announced, what other views toward the potential publication or improvements from manufacturing progress and also what about regulatory discussions? Thanks.

Brian Culley

Management

Yes. Of course, so with respect to OPC1, the study enrollment is complete – that has been completed from more than a year. So there has been a presentation of the 12-month follow-up data. The full publication, the full manuscript is in preparation, but you can expect that later this year. With respect to improvements that we are introducing, this is part of our total development strategy. We approach these programs with a comprehensive attitude meaning if we have an opportunity to introduce an improvement there may be a short-term delay but if it has a long term benefit with respect to our competition or increases our probability of success obviously we run those numbers to make sure it makes sense to conduct that so, that is part of what we are doing right now with OPC 1 and with respect to the I think the third part you asked about regulatory some of the data that recollecting which will support our regulatory strategy that will be packaged up put into a meeting package and uses the basis to get some back and forth with FDA so we will go to them mostly for an manufacturing meeting. First we will presumably do a clinical meeting second but we also benefit from the fact that mysterious had already had a very productive clinical meeting. Prior to their acquisition by us so we know kind of where the FDA head is at with respect to the clinical side of things so I think that meeting would be mostly refinement but, we do want to make sure we have clarity with respect to FDA’s attitude on the improvements that we are looking to introduce to the process over the course of this year.

Unidentified Analyst

Analyst · H.C. Wainwright. Your line is now open.

Okay, thank you so much Brian and congrats on the progress.

Brian Culley

Management

Thank you.

Operator

Operator

Thank you and our last question comes from the line of [indiscernible]. Your line is now open.

Unidentified Analyst

Analyst

Hi, this is Tucker on behalf of Jason. And my first question is for Brandi and could you review how you carried the value exactly how you value bio time ownership with its affiliated companies and talk about monetize [indiscernible]?

Brandi Robert

Analyst

Sure. Right now we have about a 5% ownership in AgeX we have about an 8% ownership in [indiscernible] and our remaining ownership in [indiscernible] is about 24%. So we look at all of those investments as opportunities to help operations but we really balance out what our needs are and when it makes sense to potentially use those investments so, we look at them from time to time we are obviously excited about the technology that those companies are working on but we balance that with meeting to fund our own operations as well.

Unidentified Analyst

Analyst

That’s great. And I just have one more question can you elaborate on what’s clinically next for OpRegen and what I mean is it seems like we have seen proxy data that did not [indiscernible] and what signals are you seeing that suggests this time maybe different?

Brian Culley

Management

I don’t know if this is the brass ring in dry AMD but there are two attributes that I think people are very interested in. One is the size of the area of geographic atrophy, so essentially how many cells have died off and what does the dead area look like and how quickly does it expand and grow, because as it grows over the area of the your macula that’s how you are losing your fine vision. And then the other one which is connected, but not in a perfectly linear way is visual acuity and visual acuity is usually measured with whatever corrected measures you have, glasses or contacts. There has been some efforts in the past. There was the company in particular that seemed to have a benefit in vision, but they saw no change in geographic atrophy. And so it caused them to investigate this and they felt that patients were learning how to improve their reading ability while they were losing their vision to AMD. So you are getting better at taking the test basically, not unlike a high school kid who learns how to do better at SAT tests taking even if they don’t have anymore knowledge. So what we are excited about and encouraged by is that we have evidence early as it is currently, but we can point to at least some case studies where an individual has had an improvement in vision which has been what we think is clinically relevant and durable over a long number of months and counting. And we have had a case study where over a period of about a year, it appears to us that the area of GA is not expanding in the area where cells were administered. So again that is – it’s…

Unidentified Analyst

Analyst

Yes, absolutely. Thanks for taking my questions and congratulations on the progress.

Brian Culley

Management

Thanks, Tucker.

Operator

Operator

Thank you. I am not showing any further questions at this time. So I would now like to turn the call back to Brian Culley for any further remarks.

Brian Culley

Management

As no further remarks, I appreciate everyone joining us this afternoon. We are obviously excited about our plans and we want to keep the momentum going. So thank you so much.

Operator

Operator

Ladies and gentlemen, thank you for participating in today’s conference. This does conclude today’s program. You may all disconnect. Everyone have a great day.