Abeona Therapeutics' (ABEO) CEO Tim Miller on Q1 2016 Results - Earnings Call Transcript

| About: Abeona Therapeutics (ABEO)

Abeona Therapeutics, Inc. (NASDAQ:ABEO)

Q1 2016 Earnings Conference Call

May 17, 2016 10:00 AM ET

Executives

Andre’a Lucca - VP Communications & Operations

Tim Miller - CEO

Jeff Davis - COO

Analysts

Jason McCarthy - The Maxim Group

George Zavoico - JonesTrading

Vernon Bernardino - FBR

Ram Selvaraju - Rodman & Renshaw

Operator

Greetings and welcome to the Abeona Therapeutics First Quarter Conference Call. At this time all participants are in a listen-only mode and a brief question-and-answer session will follow the formal presentation. [Operator Instructions] As a reminder, this conference is being recorded.

I would now like to turn the conference over to Andre’a Lucca, Vice President of Communications & Operations. Thank you may now begin Ms Lucca.

Andre’a Lucca

Thank you good morning and welcome everyone. On the call today are Dr. Tim Miller, President and CEO; and Jeff Davis, Chief Operating Officer of Abeona Therapeutics. Dr. Miller will begin the call with an overview of the first quarter and more recent highlights and developments at Abeona, after Jeff will provide additional comments on the quarter, a brief overview of summary financials and provide a snapshot of our financial position and review the upcoming investor conference calendar. Following that we will open the floor to few questions.

Before I turn the call over to them I need to remind our listeners that remarks made during this call may contain forward-looking statements that involve risks and uncertainties. Forward-looking statements on this call are made pursuant to the Safe Harbor provisions of the Federal Securities laws. Information contained in the forward-looking statements is based on current expectations and is subject to change and actual results may differ materially from forward-looking statements. Some of the factors that could cause actual results to differ are discussed in the reports filed with the SEC. These documents are available on our website at www.abeonatherapeutics.com.

With that said, it is now my pleasure to introduce Dr. Tim Miller. Dr. Miller, you have the floor.

Tim Miller

Thank you Andre’a, I want to welcome all investors and with another stakeholder of Abeona to our call. It's been quiet transformative year for the company. Abeona is now a clinical stage company and we’re focusing on developing gene therapy and plasma based products sever and life threatening disease. This really wouldn’t have been possible without the support of additionally [ph] multiple foundations who initially supported the foundation and formation of Abeona.

Back in 2013 we were able to bring in over a dozen foundations to help support these programs. They looked around at the space in the emerging gene therapy companies with the recent developments in the -- of course of the gene therapy space and they saw that looking at AAV gene therapy [indiscernible] and some of the best ways that they thought would be [indiscernible] and they came and supported Abeona.

And now as we’ve gone through our transition over this past year Abeona is really a rare diseases company. Rare diseases is one that affects fewer than 200,000 people in the United States. There are nearly 7,000 rare diseases, which involve chronic illness, disability, and often, premature death. There are more than 25 million Americans and 30 million American that have one and there are rare diseases can be found and affects people in any age group, about 50% of people affected are children which is about 15 million, and rare diseases account for 35% of deaths in the first year of life. These diseases are often poorly diagnosed, are very complex, and have no treatment or not very effective treatment, over 95% of rare diseases do not have a single FDA or EMA approved drug. And most of these rare diseases are often caused by changes in genes, 80% of them are genetic in origin and can present at any stage of life.

In Abeona, as we focused over the past year we have plasma therapies that we are developing, we also have gene therapies that we’re developing. Gene therapy is the use of DNA as a potential therapy to treat a disease and many disorders, particular genetic diseases caused by a single genetic defect. Gene therapy aims to treat disease by delivering the correct copy of DNA into a patients cells, the healthy functional copy of the therapeutic gene and helps the cells function correctly. In gene therapy, DNA encodes a therapeutic protein and is packaged within a vector or often a naked virus, which is used to transfer the DNA to the inside of cells within the body.

Gene therapy can be delivered by multiple different methods either by a direct injection, such as an intravenous injection or directly into a specific tissue within the body, where it is taken up by individually by the cells. There are many approaches, our initial therapies ABO 101, 102 and 201 are focusing on delivering an AAV by intravenous delivery to treat the whole body of the diseases. We are developing these next generation adeno-associated virus gene therapies and unlike the AAV vectors found in nature, the AAV vectors used by Abeona have been genetically-modified to deliver the correct functioning copy functioning copy of the gene into cells, essentially AAV vectors are delivery vehicles.

Our initial programs, again where we were able to receive so much support from rare disease community is focused on lysosomal storage diseases such as Mucopolysaccharidosis IIIA and IIIB, also known as Sanfilippo syndromes type A and type B, MPS III is a progressive neuromuscular disease with profound CNS involvement. Our lead product candidates, ABO 101 and 102, have been developed to replace the damaged malfunctioning enzymes within target cells with the normal functioning version. ABO 201 is the similar product, using a AAVs to deliver that correct lysosomal gene that is defective in Juvenile neuronal ceroid lipofuscinoses, delivered via a single injection these drugs are given only once.

The first quarter of 2016 has been one of significant growth and transformation for Abeona Therapeutics from a number of perspectives. First in foremost Abeona announced this morning that the successful dosing of the first MPS IIIA patient with ABO 102. This is a Phase 1-2 trial that the first demand [ph] dosing of an AAV9 delivered by an intravenous injection that was conducted again at Nationwide Children's Hospital, a clinical site of two other clinical stage in the gene therapy companies, and many of whom I believe on this phone call are probably familiar with.

Our study is an Open-Label, Dose Escalation Study, and important to note that is supported by a 25 patient Natural history study also conducted in Nationwide Children's Hospital, where all patients went through one year of follow-up assessment. This has been important because it’s helps guides the design of the clinical study protocol and helps to validate the outcome measures for the trial as we then continue to enroll this patients for MPS IIIA and IIIB. The data from this Natural history study has been recently presented and maybe published in our manuscript soon.

We would like to remind everyone that AOB 102, again for the treatment of patients with MPS IIIA does have orphan product designation from the FDA in the United States, and the rare pediatric disease designation. And we are pleased to have -- to report that we have sufficient drug available to treat multiple patients in the United States and in clinical trials for additional out of United States sites, our approach to rare disease gene therapy because of much of the support from international community has started [ph] to bringing these trials globally, over 70% of this children with Sanfilippo syndromes don’t reach the age 18. So there is a pressing and critical need for these unmet medical need for this therapy. And that we’re hoping to be able to bring this therapies in the Europe and into Australia later this year.

We look forward to presenting data from this exciting first in men clinical trial later this year. Additionally due to some other milestones that we have in the quarter, we’ve added some new team members from our Dr. Kaye Spratt, who as a Vice-President of Regulatory and Quality at Abeona and Adam Davis. Dr. Davis is our Director of Manufacturing here in Cleveland. And we’ve completed the build out of our gene therapy facility here in Cleveland, Ohio and as we've done on just to pursue our global strategy, we received the genetic modified organs and ethical committee approvals for both ABO 101 and ABO 102 in [indiscernible].

And so with that we believe that we are well positioning ourselves as a rare disease company we have a number of other things that we’ll like to discuss and right now I'll turn it over to Jeff Davis, as our Chief Operating Officer for a brief updates on the SDF plasma program and a review of last quarter's financials. Jeff?

Jeff Davis

Thank you, Tim and thanks to all the investors that are participating in the call today. I'll give a little bit of the background on the plasma program side of our business as well as an update on the financials on our upcoming events and conferences and then I'll cover a little bit of ground that have been covered in earlier calls because there is some new analyst and investors participating in the call. On plasma side of the business, we have a plasma protein program and Alpha-1 Antitrypsin, for those unfamiliar with human plasma derived drugs this represents about $15 billion global market that is growing and roughly 10% annually. The program that we are leading with is another orphan disease called Alpha-1 Antitrypsin deficiency. Patients that do not make this specific protein in their liver actually develop an imperative form of COPB or chronic obstructive pulmonary disease and we in late 2014 licensed a process called Salt Diafiltration. Salt Diafiltration uses sodium citrate as opposed to ethanol as it means to help extract and purify proteins from human blood plasma.

During 2015, we successfully worked on finalizing and optimizing that SDF process for Alpha-1 Antitrypsin. We did that with a single contract manufacturing organization based here in the United States. Later around the turn of the year we wrapped up our work with that contract manufacturer and engaged with a new contract manufacturer based in Toronto called Therapure that we believed to be better suited to help us complete the scale of and produce both some preclinical batches as well as ultimately the large clinical batches and the clinical material needed for our clinical trials. That process kicked off since February of this year and is going very well and we hope to keep you updated as we move forward. We also on the IP front following the finalization and optimization of our process we have filed additional pattern applications to further build walls around our Salt Diafiltration process and will keep you posted on that as well.

From a regulatory perspective we've had an initial meeting with the FDA to discuss the process and the necessary preclinical CMC and clinical plans that they would like to see with our Alpha-1 Antitrypsin product following inputs and suggestions for them on the clinical program including the potential Phase 4 requirements. We've submitted additional clinical program plans and a Type-C meeting request and we expect to have feedback from the FDA on that by mid-June of this year and I can also report very much like on the gene therapy side the patient advocacy groups being very supportive and helpful in the Sanfilippo program. So I can tell you that the Alpha-1 foundation which is leading patient advocacy group for Alpha-1 deficiency is equally very supportive and helpful and what we are trying to do with that in the Alpha-1 community. So that is an update on where we are on the plasma side.

I think we will respect the financials there is nothing really earth shattering, we filed the 10-Q after the close yesterday as you can see from the Q, as well as our press release our cash and cash equivalent to marketable securities as of end of the quarter was 37.4 million compared with 40.1 million at the end of the year, so we’ve earned about 2.5 million in the first quarter or less than a $1 million a month. That will of course ramp as we continue to move these programs into the clinic, but we believe we have sufficient cash for the next two years. The loss for share was $0.17 for first quarter compared to $0.10 in the comparable quarter in 2015 and revenues were a low bit down due to reduced royalties on MuGard program. So the first quarter financials as I said are available in the Q that was filed after the close yesterday.

I think lastly before we sort of open it up for questions we are participating in some upcoming events and conferences, we will presents on Wednesday May 25 at the UBS conference here in New York, we will also have a presentation slot to the Bio-conference in San Francisco and on June 9 we will be presenting at the Jefferies conference here in New York. So there are opportunities for investors and analysts as well to work in some one-on-one meetings around those conferences.

And I think with that, that concludes to the prepared statements and we can open it up to some Q&A.

Question-and-Answer Session

Operator

Thank you, well now we are conducting a question and answer session. [Operator Instructions]. Our first question is coming from the line of Jason McCarthy with The Maxim Group. Please go ahead with you questions.

Jason McCarthy

Good morning guys, congratulations on dosing the first patient with 102, it’s a really big milestone for the company, it’s a great achievement. I know that this was developed at nationwide as was Avexus [ph] Vector it’s the same back bone. Can you talk about the Avexus data, similarities between your drug construct and theirs, because they didn’t show some outstanding data in SMA just recently and it appears in my opinion that you might be just about a little bit behind them, may be a year, therapeutically and if they dosed a higher dose than you are using, we did think that you could see the similar safety profile, similar protein expression and potentially efficacy as soon as next year, can you comment on that?

Tim Miller

Yes sure Jason, thanks for your question and surely happy to answer. So our program is very similar to Avexus which also spin out of nationwide at certain [indiscernible], it does use an AV9 vectors similar to ours, we would also point out that it is one of the self-complementary vectors which helps induces early expression and where you see 10 to 100 fold more expression than the single stranded versions of the vector and this is important as you know because of cost correction in these diseases where when you have a soluble enzyme it can be secreted out of the cells and taking up by the cells around it, so we’ll be able to leverage that for the 102, very happily.

We would also point out that it’s delivered as intravenous injection similar to Avexus product. So when you look at -- your line is up and well it’s AV9 and its delivered intravenously and it’s the self-complementary vector and we are making an apples-to-apples comparison. From the vector’s standpoint and delivery method, so it’s a different trans team, but again the idea has been to target the whole body of the disease particularly the CNS as AV9 is the only vector that can cross the blood-brain barrier, so to treat these treats these kids with the CNS manifestation is certainly our desire, but when the kid gets a little bit older we want to make sure that the whole body has potentially been corrected.

They have. Avexus I believe involved 15 patients and that’s quite a remarkable data that was recently presented at ASTCP conference. I agree with you Jason that we are about a year behind and I'll looking forward to reporting additional bio potency and potential efficacy measures in the future.

Jason McCarthy

And for IIIA or in IIIA, the first patient dose, we should see some early data, enzyme expression safety sometime in Jan, when do you anticipate dosing the second and third patient in the first cohort? And what's the timeline for opening trial sites in Europe, particularly Spain and over in Australia?

Tim Miller

Sure, so we are enrolling these patients consecutively, this is a Phase 1-2 study, it certainly has to go through consecutive enrollment. We look forward to updating everyone with as close of the cohort for example and potentially looking at how we might report some of the data that does come in. We will be looking at enzyme activity and a multiple body fluid and gags and more specifically Heparan Sulphate which is the specific sugar that affected in this kids.

And I guess to your last question, we have already achieve two of the three necessary regulatory filings for one of the two in Spain, the genetically modified organs and the ethical community submission and hope to be able to update everyone with the trial that will be ongoing in Spain potentially in the next quarter. But we will all see.

Jason McCarthy

Okay and just one more, can you -- just give us an update on the IIIB program with 101 and what the timing maybe for the IND filing? Thank you.

Tim Miller

Sure, so ABO 101 has also been moving along, we have completed all the preclinical developments and are, again we do have GMO and CEIC approvals in Spain and are looking forward to providing an update from a regulatory approvals in both United States and in Spain sometime in June.

Jason McCarthy

Okay great, thanks Tim, thanks for taking the question.

Operator

Thank you. Our next question comes from the line of George Zavoico with JonesTrading. Please go ahead with your question.

George Zavoico

And thanks for the update, congrats as well for giving the first patients dose, pretty exciting stuff. First question is for Jeff, I guess for the plasma protein program, you mentioned the AAT, one question about that and that is that Alpha-1 Antitrypsin is emerging as a very -- well not exactly how potent, but an important player in anti-inflammatory responses, not only just through the deficiency, but also for a specific disease, are you looking for broader application rather in just Alpha-1 Antitrypsin deficiency?

Jeff Davis

I think our initial approach from a regulatory perspective is to just go and get an allowance for exactly what the prior for Alpha-1, approved Alpha-1 Antitrypsin got approved and it's simply argumentation therapy for those have been diagnosed with a clinical deficiency in the gene that causes inherit CLPD. I agree with you, I mean it is Alpha-1 Antitrypsin is known to be a very broad based anti-inflammatory, it’s being tested in a lot of different conditions where a systemic inflammatory condition is known to exacerbate the condition. And there has been recent data that’s been very interesting, including CSL did a study called the Rapid Study. It was also in CLPD, but they were using some other clinical endpoints as well that showed some very interesting and positive results. And I am aware that other players in the field are looking at in a variety of conditions. But I think the sort of fastest way to approval for us, and to get it on the market, to start generating revenues, is just to use the same sort of pathway that the prior for any Alpha-1 get approve with.

George Zavoico

And in that regard moving over to therapeutic, does that give you more efficiencies and lower cost of goods for the kind of -- for the scale?

Jeff Davis

I believe, I mean they are just better suited for us than the initial CMO that we were working with. They have a very significant CMO business, there they make other approved proteins that are marketed there and not only are they better suited to help us sort of scale up and make the clinical material for the trial, but I think they could also be a producer for us for the first sort of couple of $100 million in revenues.

George Zavoico

And so for commercial scale for sure that?

Jeff Davis

Yes, absolutely.

George Zavoico

And you didn’t talk about IVIG, is that going on in parallel or serially?

Jeff Davis

It's neither directly in parallel or serially. We did some initial confirmations of the downstream chromatography and sort of purifications steps at the first CMO, we kick off the Alpha-1 with the new CMO and we will a little bit down the line in parallel, but still not yet kicked off, hope to start the Alpha-1 program. The IVIG program.

George Zavoico

Okay. And then a question about -- then with regarding the trial that just started. Nationwide also did the natural history trial if I'm not mistaken and those patients are still available I presume. Are some of them being moved into the trial now or have they progressed so far that they can't?

Tim Miller

Hi, George. This is Tim. So yes so that nationwide enroll 25 patients in the natural history study. All of them are through the one year with the follow up and many of them particularly when the MPS IIIA group are certainly looked at as potential candidates for the gene therapy trial for 102 and I can say that being in the natural history study thus did not guarantee a spot in the clinical trial, however that is certainly a population that is being looked at particularly because there is a year worth of longitudinal data on those patients.

So the nice thing about the natural history study which is really the only one of its kind in the world that we’re able to leverage the data from this population which is important from the FDA perspective on look at potential approvals down the road. It has validated a lot of the outcomes assessments as we look towards the 6 month and 12 month efficacy endpoints and I am sure that many of the natural history patients will be in that clinical trial again because there is that year of longitudinal data.

George Zavoico

It seems that with that data if and hopefully when the gene therapy changes and the enzyme you did more of the right enzyme and you start to make the enzyme and clearly deposits in the lysosomes that you’ll -- with the previous data you should be able to see an inflection point and that should be multiply convincing I guess, rather than just comparing it to historical data and natural history trial. So yes I think that's a tremendous advantage I would imagine for your patient enrollment.

Tim Miller

We know that within two weeks in preclinical models of the disease that we’re able to clear out the cellular storage pathology which of course is rather remarkable and multiple tissues when giving these AV-19 therapies by intravenous injection, so then we know that looking out at three and six months our post injection, we do see multiple fob changes in enzyme activity in multiple tissues which of course has a concurrent [ph] reduction in the sugar content, again the underlying storage pathology. So we are hopeful that -- and we look out at that the clinical space when you look at other trials that are using this AAV delivered by the intrathecal or delivered by IV and that they are seeing changes that are clinically remarkable and they certainly have demonstrated safety, so we look forward to providing an update on certainly some of these [indiscernible] assessments and also efficacy as we move through the trials.

George Zavoico

And then final question regarding the AAV vector. You mentioned, obviously it crosses the blood-brain barrier, do you see pretty much uniform distribution with the whole vector across most organs or is there any particular organ that seems to take it up, is it concentrated in the across the blood-brain barrier or is it sort of more uniformly distributed across the body?

Tim Miller

Well I think it's rather broadly appreciated that the liver certainly takes up more of the drug than many of the other organs due to first pass effects, but we see similar amounts in the brains we do than say lungs, heart, spleen. So we see it by bio distribution, we are able to detect the increased enzyme activity and the reduction of gags for example in that tissue. So we do see across the CNS and I think that that’s becoming more and more appreciated and as you see more companies using AV9 particularly for CNS disorders that you do see with an intravenous injection very broad and robust coverage across the entire CNS. For months, years in the preclinical animal models. And importantly we have seen this for all three of our lysosomal storage diseases programs, so for MPS IIIA, IIIB and for the CLN3 Juvenile Batten program. And we haven’t talked a lot about that today but certainly that is also moving forward and we’re looking forward to initiating IND enabling tox studies very, very soon and this t be able to get into clinical trials for that patient population is well.

Operator

Our next question is from the line of Vernon Bernardino with FBR. Please go ahead with your questions.

Vernon Bernardino

Congrats on though thing the first patient, so I am sure that’s all very exciting and -- but also perhaps scary at the same time. So if I am to think about the patients whose recently been given the ABO 102, what perhaps have you seen since the patients dose and what maybe -- what we would expect in the initial response in the first days or weeks after the patient has been given 102?

Tim Miller

One thing with these AAV gene therapies is that particularly in these rare diseases, you’re not going to see a lot of changes immediately in the first couple of days. In the end the patients are kept in the hospital for monitoring for safety in particular and we’re pleased to report that there have been no reportable safety events, the patient has been discharged and is doing well. There was a number of follow up appointments within the first 30 days and we look forward to being able to report early measurements of bio potency which will again be really enzyme activity and the gags and Heparan Sulphate assessments. So nothing really can be detected in the first couple of days but you’re looking at it one month, three months, that’s when you’ll start to see some measurements form bio potency.

Vernon Bernardino

Are there any things that you specifically would look for as far as safety is concerned that you have seen as experienced from other gene therapies?

Tim Miller

One of the strengths of this program is how maturely they were with working with Nationwide Children's Hospital and through there clinical programs for gene therapy they have really the best in world leading experience in treating children with intravenous AAV gene therapies. And so being able to leverage the clinical protocol, the experience of the clinical teams there has certainly been something that we are proud to be a part of and again looking around at the space and other AAV programs, I think it’s broadly appreciated these AAV gene therapies so far demonstrate the safety. There is always going to be some risk as these are first-in-man trials and we hope that our patients end up getting very, very well and that the drugs are safe.

Vernon Bernardino

Perfect and I remember from the brain scans that you have presented in preclinical studies, would you expect that similar distribution in human subject?

Tim Miller

What we have done in non-human primate studies for MPS III program and have seen a 100%-200% increase in enzyme activity in the CNS six months post injection. So that’s above the wildlife [ph] levels, so we do know that there is broadened robust coverage into this CNS, I think -- I hope that answers your question.

Vernon Bernardino

Yes and as Jeff had mentioned there is still some ongoing activities with INDs or 101, is there anything to expect differently from the fact that he target appears pretty weak [ph] and that they may be related to the activity that are still on going for the IND?

Tim Miller

So 101 and 102 both are AAV 9 programs that both delivered intravenously, all the preclinical work for the both program has a first and completed and we look forward to being able to update everyone on the MPS IIIB program very soon. We would expect that again that the results that we have seen preclinical have done very similar between MPS IIIA and IIIB, so and they are delivering that is to same so we’re certainly anticipating some more safety levels and potential efficacy.

Vernon Bernardino

Perfect, looking forward to follow up results and the next sessions [ph]. Thanks guys.

Operator

Our next question is from the line of Ram Selvaraju with Rodman & Renshaw. Please go ahead with your question.

Ram Selvaraju

A lot of the clinical state questions that already have been asked and answered. But I wanted to get a general sense from you guys on two matters. Firstly, with respect to recent developments in CRISPR/Cas9 space, how that maybe influencing your thinking from a strategic standpoint as you move the Fanconi anemia program forward? And when you might be thinking about potentially moving into collaboration arrangement on that indication and potential in others? And how your CRISPR/Cas9 presence compares to that other firms of the space?

And secondly, if you could provide us with some commentary on what additional SDF Alpha platform produced PDP is, you might expect to move forward into clinical development in the foreseeable future? And if all of those are going to be routed from a manufacturing development standpoint, do TheraPure -- what TheraPure [ph] is only going to handle the AAP candidate?

And then finally, just looking for some housekeeping guidance on stock base compensation and stock awards made to employees and consultants, given the fact that these probably constituted at least by my reckoning the bulk of the non-cash items impacting you net loss number, the difference between the net loss and the actual cash utilized in operating activities in the quarter? Thanks.

Tim Miller

Sure thanks Ram. One of my answer to your CRISPR question and Jeff maybe you can take the next two. So Ram, I think our CRISPR program, which we have in house have been able to through our licensees -- I am sorry our licenses has been able to target in our children [ph] 50 different orders. First announced program as far as Fanconi anemia Type C, we have been moving forward with our two approaches that we are taking is an ex-vivo, sensor corrected approach, and our second generation approach which will be an AAV mediated potential direct injection for that program. Like many of the other programs in this space using CRISPR, we are approaching this cautiously and I think you probably heard through many of the recent announcements that the technology itself gaining rounds from again a proof of concept standpoint, but really the challenge with a lot of that a CRISPR messages, translating it from taking it out of the patients [ph] cells and putting it simply in the human.

And gene therapy is all about delivery, so we are certainly watching the space very internally and watching with all of our colleagues are doing and certainly developing those programs continually in house, but trying to seek some regulatory feedback about what the FDA will be looking for from again an off target effect versus specific to be in and correctional function, that is what we are trying to very cautious on how approaching that, but being smart taking things a step at a time, we want to crawl, walk and run before we are announce a lot of partners in our program, but looking forward again to updating everyone on that.

We did have a recent poster represented at one of the CRISPR conference that highlighted some of the accomplishments of the research team in the University of Minnesota and certainly working with them the advantage programs. Jeff?

Ram Selvaraju

Okay thank you.

Jeff Davis

I think on the last two questions, on the second question, we are excited about our collaboration with TheraPure. The initial protein is Alpha-1 Antitrypsin but this is great group to be collaborating where they have a lot of expertise and so we do anticipate continuing to work with the after the Alpha-1 entire into IVIG and even potential sort of orphan proteins. I think with respect to the non-cash stock and option compensation because I have gotten some of those questions because it makes our SG&A look out sized and obviously seen currently greater than the cash burn or the cash portion of it.

Most of that occurred due to onetime grants to Directors and new employees around the acquisition last May or about 12 months ago that would be on a therapeutics Cell C [ph] and basically putting in place a new stock option plan that occurred around our annual meeting last year. The way the stock option and the stock -- the stock is actually accounted for is you amortize that expense over a vesting period and that was done also at the time the stock was quite high having sort of run up last May. On the options, the component of that are options that go to consultants and those if are you amortize those over the life of the option and they tend to fluctuate based on wherever the exercise price is. So unfortunately since last May it has sort of the large appearance in our SG&A although it is non-cash for investors and analyst, it is very clearly sort of delineated in our Ks and Qs.

Ram Selvaraju

Okay. So going forward just to understand this better the stock option compensation expense line item in the cash flow statement is not anticipated to be as high as what you recorded at this quarter or is that a fair assumption going forward based on your understanding of what the amortization requirements are?

Jeff Davis

It's my understanding that it will stay fairly consistent with that based on investing schedule of the stock grants as well as the length of the options outstanding there. It's not anticipated to go up and then I think it could actually go down based on depending where the stock price is and how you have to impute some value in those options when there are sort of out of the money.

Operator

Thank you. At this time I would turn the floor back now to Dr. Miller for any further or closing remarks.

Tim Miller

I want to thanks everyone for joining us today. Truly been a thanks informative year for this company and we look forward to updating all of our shareholders and foundations and our patients on our progress as to new AOB 101 and 102 further in the clinic and thus continue our expansion overseas in the clinical trials. So stay tuned and I look forward to catching up with everyone again soon.

Operator

Thank you. This will conclude today’s conference. Thank you for your participation. You may now disconnect your lines at this time.

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