BioTime, Inc. (NYSEMKT:BTX)
Q2 2016 Earnings Conference Call
August 9, 2016 4:30 p.m. ET
Dan Lawrence – Director of Investor Relations and Corporate Communications
Adi Mohanty – Co-Chief Executive Officer
Michael West – Co-Chief Executive Officer
Russell Skibsted – Chief Financial Officer
Keay Nakae – Chardan Capital Markets
Good day, ladies and gentlemen. Welcome to the BioTime 2016 Results Conference Call. [Operator Instructions] As a reminder, this conference call is being recorded.
I will now introduce your host for today's conference, Dan Lawrence, BioTime's Director of Investor Relations and Corporate Communications. Dan, please go ahead.
Thank you, operator, and good afternoon everyone. Thank you for joining us today for BioTime's investor conference call and webcast to review the company's results and key accomplishments for the second quarter 2016 and recent corporate developments. There will be a tape replay of this call which will be available approximately two hours after the call's conclusion and will remain available for seven days. The operator will provide the replay instructions at the end of today's call.
With us today are Co-Chief Executive Officers, Adi Mohanty and Dr. Michael West; also Chief Financial Officer, Russell Skibsted. Each will make prepared remarks and then we will take questions from our covering analysts and institutional holders.
Before we get started, we would like to remind you that during the course of this conference, the company will make some projections and forward-looking statements regarding future events. We encourage you to review the company's past and future filings with the SEC, including, without limitation to the company's forms 10-K and 10-Q which identify the specific factors that may cause actual results or events to differ materially from those described in these forward-looking statements. These factors may include, without limitation, risks inherent in the development and/or commercialization of potential products, uncertainty in the results of clinical trials, or regulatory approvals, need and ability to obtain future capital, and maintenance of intellectual property right.
And with that, I'd like to turn the call over to Adi Mohanty, Co-Chief Executive Officer of BioTime.
Thanks, Dan. I'd like to thank everyone for joining us on the call today. During the second quarter, we once again made meaningful clinical progress on our key therapeutic programs, Renevia in medical aesthetics and OpRegen in dry AMD. These therapeutic candidates represent our two technology platforms, our industry-leading Pluripotent stem cell technology and our HyStem proprietary delivery technology. Our early-stage work and additional product candidates based on our two platform technologies is also progressing well with the goal to build our future therapeutic pipeline.
We also strengthened our cash position during the quarter by completing a successful equity raise on attractive terms involving high quality new and existing investors. All-in-all, the past few months have been very productive. Our stated near-term strategy is to focus on three primary objectives that are designed to drive products to patients while increasing shareholder returns. First and foremost is advancing Renevia and OpRegen through the clinical study process.
Biotechnology companies build shareholder value by moving product candidates successfully through the clinical trial process. Every stage of clinical progress adds value. Moving a product candidate from Phase 1 to Phase 2 adds a good deal of value. Moving a product candidate from Phase 2 to Phase 3 is even more important, because not only does it add significant value for shareholders, but also gets the product closer to the patients that need them. Even stepping from discovery to preclinical often increases valuation.
There are many recent examples of clinical progress translating into significant shareholder value. Acadia more than doubled this market cap when it released positive Phase 3 data for NUPLAZID. Kythera was acquired by Allergan for 2.2 billion once KYBELLA the drug that destroys fat cells under the chin was approved by the FDA. Our goal is that Renevia and OpRegen to join this list as clinical progress is achieved.
Our second focus is simplification. Simplification is important for BioTime not only with our corporate structure and operations, but also in the way we communicate to our current and potential shareholders. Simplification helps the company focused on the high priority activities, and simplification also helps us to communicate more effectively to prospective investors, analysts and partners. As an example, we believe we gained some valuation when we deconsolidated a subsidiary Asterias' financials from BioTime's financial this past May.
Separating their financials from ours helped investors more easily understand our business. We demonstrated the benefits of our third focus unlocking the value of our non-core subsidiaries in December of last year when we took OncoCyte public. At that time we distributed about $20 million of OncoCyte shares to the BioTime shareholders. We will continue to work with our non-core subs to identify further opportunities to benefit BioTime shareholders.
Now let's move to the clinical progress with BioTime's two core therapeutic programs, Renevia for facial aesthetics and OpRegen in dry age-related macular degeneration or dry AMD. Renevia is our most advanced product candidate. It is a combination of the patient's owned cells with our HyStem delivery platform. The HyStem delivery platform is designed to facilitate the stable engraftment of transplanted cells. Renevia is injected into portions of the patients face where there is fat loss in order to promote facial tissue regeneration.
This procedure can be completed during a single outpatient visit that can be easily performed in a doctor's office. Our pivotal clinical trial for Renevia is for HIV-related facial lipoatrophy. Lipoatrophyis the term used for fat tissue loss. There are about 350,000 people in Europe with HIV related lipoatrophy. We are striving to make Renevia available to these patients by the second half of next year. At the same time, we viewed the Renevia pivotal trial as a gateway study that could serve as the basis for broader indications in facial fat loss which commonly occurs with aging and represent a much larger multibillion-dollar market.
Our Renevia clinical trial continues to enroll patients and is on track to complete patient enrollment by the second half of 2016.We expect top line efficacy data in the first half of 2017, if the data are positive, we plan to submit a CE Mark filing in Europe in the first half of 2017.We would expect potential approval in the second half of 2017.If so Renevia could be on the market in Europe and certain other countries as early as the second half of next year.
The efficacy measures for the trial include change in tissue thickness measured by ultrasound. At the same time we've been using 3D volume metric change as a secondary measure at our current pivotal trial while ultrasound has been an accepted efficacy measure by FDA in previous clinical trials of derma cellular [ph] products. 3D measurement has emerged as a preferred measurement in some of the more recent medical aesthetics clinical trials. Our use of both measurement techniques makes it easier for us to prepare for future trials in the US and other markets.
In addition to 3D and ultrasound we also have secondary measures in the Renevia pivotal trial that included aesthetic scores and patient reported outcomes. We remain encouraged by the clinical progress, patient enrollment and the extremely clean safety profile. As we mentioned during our last call with you that we've had productive communications with the FDA. Our plans for broader indications for Renevia including entry into the U.S. continue to evolve. We expect to share more details of our plans for Renevia in the U.S. in coming months.
Now OpRegen, OpRegen which targets the major unmet medical need of dry AMD.AMD is a leading cause of blindness in people over the age of 60.There are two types of AMD, wet and dry. Approved therapeutics for wet AMD are widely used and generate over $5 billion in annual revenue. However there are no currently approved therapies available for dry AMD which is a much larger need and opportunity than wet AMD with nine times the number of patients. OpRegen is in a Phase 1/2a dose escalation clinical trial from the dry form of AMD.
In June the Data Safety Monitoring Board or DSMB authorized moving forward with enrollment and dose escalation to the second cohort. We had anticipated this approval on our last call and now have already started treating patients in the second cohort. The second patient cohort is receiving a higher dose of OpRegen. The dose was increased from 50,000 cells to more clinically significant 200,000 cells. We are encouraged by the safety profile of the product to-date several months past initial dosing.
Looking ahead we expect to complete the enrollment of the second cohort this year if the data are positive we anticipate approval from the DSMB to proceed to the third cohort before the end of this year. The OpRegen program is being funded in part by grants from the Israel Innovation Authority or IIA. In June our program was awarded a new grant for 2016 of approximately $2.2 million. The OpRegen program has thus far been awarded grants providing approximately $9.6 million of non-dilutive funding.
Our two platforms pluripotent stem cells and HyStem for delivery of cells and molecules enable us to have a very rich pipeline. We are focused on leveraging these platforms to generate many product candidates that could represent potential curative therapies for patients who have degenerative diseases with few or no options. As we advance additional product candidates into the clinic, our goal is to create options for patients while generating value for BioTime shareholders. Major international pharma companies have been actively building their pipeline. As we continue to generate and publish clinical data on our pre-clinical candidates we believe we will be able to leverage our early pipeline along with OpRegen and Renevia to enable even more meaningful conversations with potential corporate partners.
Briefly turning to our subsidiary Asterias, the SCiSTAR Phase 1/2a clinical trial in complete cervical spinal cord injury with the candidate OPC1 has continued to make progress. The trial completed enrollment and dosing of the first efficacy cohort in July. This program is being funded in part by a $14.3 million grant from the California Institute of Regenerative Medicine. As a reminder, this trial is for patients with complete cervical spinal cord injury. There are no therapeutic products for these patients today.
One of the patients in this trial was featured in a two-part television news story in July the story shows an 18-year-old boy who suffered an injury the day before his graduation and it is patients like these that we hope to serve with many of our technologies. Asterias' management plans to discuss at second quarter results and corporate developments during a conference call on Monday, August 15.Of note, our ownership percentage of Asterias is now approximately 49% as of May 13, 2016.
We invite you to plan -- listen to that call for an update on their programs. Our other publicly traded subsidiary OncoCyte has been making good progress towards its first commercial product and plans to host its second quarter conference call in August the 11 to provide a more detailed update on all its recent progress. We invite you to listen to that call for a full update on their programs.
As our public subsidiaries continued to demonstrate their ability to make progress and to fund their -- operations we're able to focus more on creating value from our non-core assets which are continuing to evolve for example LifeMap solutions are digital help subsidiary continues to gain traction with customers and world-class institutions.
In June, Mount Sinai -- Health System launched a new mobile application for patients called Mount Sinai NY. This would develop with LifeMap solutions. The app will serve as a one touch patient experience featuring centralize information and services that provide greater access to and utilization of health services offered at Mount Sinai Health System.
LifeMap continues to grow towards more independence and allows us the freedom to access option as we work on simplification and locking value. Now let me turn the call over to Dr. Michael West who will talk a bit about our continuing science leadership particularly are exciting research focused on pluripotent stem cell technology, we have a powerful R&D engine driven by our technology leadership which we believe will produce even more product candidates that will have the potential to improve all of our lives.
We expect the programs from this R&D engine will continued to add to our clinical pipeline. Mike.
Thank you, Adi. While the biotechnology industry is increasingly recognizing the power of pluripotent stem cell technology and in particular BioTime's leadership in the space, we believe this is due to the power of the platform itself and frankly to the disappointing outcomes from multiple adult stem cell derived products and development.
Of course those stem cell therapeutic candidates don't use pluripotent stem cells which are our focus. We believe that there are three important criteria to recognize about our technology to understand these trends first, pluripotent stem cells are infinitely renewable. This allows indefinite scalability of product potentially lower cost to goods dramatically improve generic infirmity and the quality of the products.
Second, pluripotent stem cells can make all of the cell types in the human body. This allows us to carefully choose from thousands of potential cell types to prioritize product development and choosing those with the greatest market potential and the lowest risk profile and therefore potentially the greatest reward for patients and our shareholders.
Third, cellular products made from our master cell banks for pluripotent stem cells have a very young profile, this strong scientific support for the contention that these cells maybe able generate disease tissues more powerfully then ever seen in the past with adultery cells. This last property of our technology was the subject of an announcement we've made in June regarding a launch of an unlined resource called Embryonic AI had the met annual gathering I describing for the first time by collaboration underway between BioTime and in silica medicine to use deep learning, supercomputer algorithms to identify previously unknown biology in our cells.
Discoveries made to potential use to trigger in humans the profound scarless regeneration seen in animals that can re-grow even suffered limb, damaged hearts or brain. We call this Induced Tissue Regeneration or ITR, and BioTime plans to lead in this promising new application of this technology. In addition to presenting our first look as ITR we in the subsidiaries to -- received the diverse industry meeting for example, reviewed its OPC1 spinal cord injury program during in oral -- session International Society for Stem Cell Research or ISSCR annual meeting in June. And our cancer diagnostic subsidiary OncoCyte presented clinical data from the study of non-invasive bladder cancer diagnostics at prestigious ASCO annual meeting in June. The data showed that the diagnostic demonstrated the high level of sensitivity and specificity in the non-invasive detection of Urothelial carcinoma which is the most common type of bladder cancer.
So in summary, our core technology pluripotent stem cell is in our opinion experiencing an important inflection point. The power of the cells is now clear to a large number of pharmaceutical companies as a leading modality to address the unmet needs associated with chronic degenerative diseases.
A simple search of scientific publications relating to pluripotent stem cells on PubMed shows over 32,000 scientific papers, and technology leaders in this sector BioTime and its family of companies have an historic opportunity to lead in this important revolution in the making.
So with that I'll turn the call over to Russell Skibsted our CFO who will discuss our financial results and the recent offering. Russell?
Thanks, Mike. Good afternoon everyone. As we've been saying we are focused on simplifying our business and increasing transparency. One important example of this occurred this past quarter when Asterias Biotherapeutics completed its most recent financing. With our ownership at about 49% we now are no longer required to consolidate the operating results for Asterias into our financial statements.
We believe this change helps investors better understand the financial performance and condition of BioTime's operation. GAAP and therefore the SEC require us to show a 100% of a majority owned subsidiaries numbers even if we own only a little over 50%. This means that by the time is required to show on its financial statements 100% of the subs numbers including assets liabilities revenue expenses and cash burn when we own over 50%. In fact, even when we are not funding a company merely because we own more than 50%, we are required to reflect cash burn in our published financial statements. We believe this is a very confusing to investors.
We recently strengthened our balance sheet, and completed a successful equity raise admitted $18.9 million from high quality new and existing investors. The additional capital allows us to continue the development of our key therapeutic programs Renevia and OpRegen through meaningful milestones. I'll now provide a brief preview of some key financial metrics. Our consolidate cash and cash equivalents totaled $27.7 million as of June 30, 2016 which does not include Asterias cash. This compares to $27.1 million on March 31, 2016 which did include the cash from Asterias.
The $27.7 million last quarter included $16.4 million from the financing. Another $2.5 million from the underwriters exercise of its over allotment option was received by us on July 5, which was after the close of the quarter and are not reflected on the recently filed quarterly financials.
As of June 30, 2016 BioTime owned $21.7 million shares of Asterias common stock and $14.7 million shares of onsite common stock, which represented an aggregate market value of about one $104 million as of that date.
Now I'll turn it back over to Adi.
Thanks, Russell. So to summarize, we're making steady clinical progress with our dry AMD and Medical Aesthetic Therapeutics programs and expect additional milestones of the second half of 2016. As we build the preeminent biotech company based on our pluripotent stem cell and proprietary delivery technologies, we are also committed to simplifying our structure and unlocking the value from our non course subsidiaries.
With that, operator, we're ready for questions.
Thank you. [Operator Instructions] Our first question comes from Rohit Vanjani from Oppenheimer and Company.
This is Marcus [ph] for Rohit. Thanks for the questions, just a few from me. I might have missed this, but what's the current BioTime ownership for OncoCyte? I know you previously mentioned that was at 58%, is that still the case?
It is the case, we're still at 58% of OncoCyte.
Okay, great. And you mentioned on maybe on the last call that FDA followed by approval halfway for facial like for atrophy, has that since changed, and if not, can you talk a little bit about the hypothetic timeframe it will have in terms of approval?
Thanks, Marcus. You're right. We did mention that the FDA indicated the device pathway which is very encouraging. We continue to have very encouraging interactions with the FDA. It is a little premature for us to be giving out a timeline. Our intentions are that very soon once we finish all the interactions with the FDA, we're preparing protocols and those kinds of conversations. As soon as we have that we will be able to share with everybody our plans that progressing well. We'll share with you more precise plans once we know more about the trial and that should be coming in the coming months.
The things are going well.
Okay, great. And just in terms of I know you mentioned a few times for Renevia and potential other applications and some other indications in the market opportunity. Can you maybe just give us little bit more colors in terms of what you view specifically a potential target indications and maybe it was estimated market size of those markets especially have right some sense of how large opportunity is?
Sure, that's a big question, and I think what the way I would answer it is we looked at Renevia essentially being a way to create that regenerate the fat tissue loss that happens whether it's with HIV related facial lipoatrophy or age related or trauma related. And when you think about age related it quickly becomes more in that medical aesthetics sometimes cosmetic use. So facial aesthetics in general is a pretty large people have talked about numbers in the range of $5 billion a year market and a substantial portion of that is what we believe clearly the market that we can target.
Many of those people who are using alternative therapies in facial aesthetics have issues with the fact that they are synthetic, they don't feel natural. They are not very consistent because overtime they seem to begin to drift or gravity pulls them down. They are also not very long lasting. So if we can create a natural longer lasting more consistent procedure which is what we think we could do which is Renevia essentially growing new tissue.
We think that there is a substantial part of that market that we can target. So that's our thinking and focus going forward. Of course as a clinical trial design develops, as a clinical trial develops and as we are able to do other studies which we plan to do in the coming months to supplement or to add to the data that we collect from the Renevia trial, we think that the Renevia trial will create a great foundation for expanded uses in the future. There are -- they are getting me -- maybe I am going to go too long because there are several other ways that Renevia could be used in many other applications. But we're going to start by staying focused on the facial part and there are other parts and other lesions people have need for creating fat tissue that we think we can target in the future. That was two block, but that's a summary of where we think it could go.
Got it. Thanks. Just last one for me; as you mentioned, cash burn for the quarter, I might have missed that, and do you guys have enough cash on hand to get through the cohort three for option?
It's good question. We didn't say that but we typically if you look at our cash burn in the quarter it's about $5 million. Actually in the second quarter it was actually little bit under $4 million. So in terms of the cash that we have, we did mentioned that we are $27.7 million that with the burn. We've got I think plenty of cash to get through that cohort and completely through the first half of 2017.
Marcus, this is Adi. I'll add to that so when you asked specifically about cohort three, I'm sure we can get through cohort three. We can probably get through a few others too. It just we don't want to reach out too far. I am positive we can get to a cohort three.
Got it. Thanks, guys.
You bet. Thank you.
Thank you. Our next question comes from Keay Nakae from Chardan Capital Markets.
Hi, thanks. Adi, with respect to your Renevia trial, was there EU -- can you just give us any qualitative comments on how that's progressing even in terms of interest in people's wanting to enroll so that you can hit the timeline that you have stated and also it just any other anecdotal promise about how it's going?
Sure. Keay. I think last time we mentioned that trials been going well and we continue to add more patients since the last time. I think through June we have great accrual of July and August that's the summer time in Europe, so that's slow down a bit, but we've got a few patients lined up already scheduled for towards the end of the August. So we feel very comfortable that we will get enrolment done in the second half of this year. The trial we mentioned the thing that we can easily say without violating any clinical trial rules is that the safety profile just continues to be absolutely fantastic which is very encouraging for us. And the patients are happy, the physicians are happy.
I think in one of the calls before I mentioned we get the see these patients, because there is untreated arm and treated arm. So we continue to feel pretty encouraged, but we have started to do is these conversations with the FDA. I mentioned that because I think the data we are collecting with not just ultrasound but even with 3D. It becomes even more important as we create these packages for the FDA.
So our path forward continues to be get the trial further along, get it fully recruited, get the data out early next year, get the U.S. trial conversation with the FDA completed and trial that we can share with all of you and get that started. All of them we still are on track I believe with everything that we planned.
Great. And then just with respect to the discussions with the FDA, is your takeaway that what they maybe suggesting is readily doable, so it's not such a high hurdle that it becomes a difficult trial to enroll and actually it's something that you can executed in a reasonable straight forward manner?
So I want to caution, right. So we have very -- these are early conservation I don't think I can tell you exactly what they are thinking until we sat down with our protocol. So we haven't presented the protocol and discuss with them, but we've got guidance, we had conversations. They were very encouraging. We think encouraging -- the indication we got was probably a device single trial will be acceptable to them. So that was very encouraging. Now we got to finish the design, we got to presented to them.
I have no doubt the recruitment and approval will be much faster or easier than the HIV related trial because now we are going to for the broader indication so we expect that, that should be easier. We've already talked to several KOLs in the U.S. who are very interested and if you want more color we can have hospital or clinical head to talk about it. But we talked to several KOLs in the U.S. who are ready to get started on it. So I think we are doing the right thing to prepare ourselves to have a quick enrolment and good trial. But I don't want to get ahead of ourselves. We have not yet had the real protocol design and trial design conversation with the FDA.
Okay. And I know you said that -- you informed us of those details once you have and is that like an end of the year Q1 or perhaps sooner.
Well, I think I'll careful because this is we are talking about regulatory agency interactions, so how do you predict that now. I know for sure it's in the coming months. Now is that three months, six months it would be unfair for me to give you a exact timing on that.
Okay. So that's fine for now. I appreciate the answers. Thanks.
Thank you. We run over our allotted time. I'll turn the call back over to our speakers for closing comments.
So, this is Adi. Thank you all very much for joining us today in the middle of summer its' a big tough. We appreciate everybody taking the time and look forward to talking to you soon. Thanks
Thank you. This does conclude today's teleconference. You may disconnect your lines at this time. Thank you for your participation.
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