Andre'a Lucca - Director, Communications Steven Rouhandeh - Executive Chairman Tim Miller - President and CEO Jeff Davis - COO.

Elemer Piros - ROTH Capital Partners.

Good afternoon and welcome to the PlasmaTech Biopharmaceuticals Quarterly Earnings and the Business Update Conference Call. At this time all participants are in a listen-only mode. A brief question-and-answer session will follow the formal presentation. [Operator Instructions] As a reminder, this conference is being recorded.

It is now my pleasure to introduce you to our host Ms. Andre'a Lucca Director of Communications at PlasmaTech Biopharmaceuticals.

Andre'a?.

Thank you. Good morning and welcome everyone. On the call today are Steven Rouhandeh Executive Chairman, Dr. Tim Miller, President and CEO and Jeff Davis CPO of PlasmaTech Biopharmaceuticals.

Steve will begin the call with a brief overview of the recent developments at PlasmaTech Bio, and Tim will then lead the call providing an overview of the recent acquisition of Abeona Therapeutics and clinical and commercial strategy going forward.

Then Jeff Davis will provide a brief overview of the recent financings and provide a snapshot of our final financial position, and review the upcoming investor conference calendar. Following that we will open the floor to a few questions.

But 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 the actual results to differ are discussed in the reports filed with the SEC.

These documents are available on our Web site which is www.plasmatechbio.com. With that said it is now my pleasure to introduce Steve Rouhandeh. Steve you have the floor..

Thank you Andre'a, good morning everybody and thank you for listening in. I'm basically going to just introduce our other speakers Tim Miller our CEO and Jeff Davis our COO.

I thought before I did that I’d just briefly review sort of the highlights of the -- what I would consider the transformative events that have taken place within the Company over the last nine months.

Most of you probably on the call are aware we've had quite a bit of news, quite a bit of activity but just to review the highlights starting eight months ago, we did an in-licensing transaction in September of last year where we in-licensed the SDF the salt diafiltration plasma technology.

We did that deal on September 19th last year to bring new technology into the Company. Shortly thereafter we did an uplifting transaction on NASDAQ and a $14 million financing that closed on December 24, 2014. Since that time we have done two additional financings of $7 million and $10 million.

We have closed the Abeona transaction to bring gene-therapy technology into the Company and our new CEO Tim Miller. And we have additionally brought the capital that they have raised from the Sanfilippo foundations of approximately $5.8 million over the course of the last two quarters.

So I think from a financial perspective and a technology perspective we're in a very strong position where I think you are going to hear a lot more from us as we develop our technology, we're going to look at other transactions other in-licensing to build out the portfolio but I think at the present time we're quite happy with the position that we're in right now and I think it's pretty exciting time at the Company.

So without any further ado I will turn it over to Tim Miller our new CEO..

Thank you Steve and I want to wish everyone a good morning to all the investors and analysts and stakeholders of PlasmaTech, including our international coalition of Sanfilippo Foundation as well as the scientific founders and clinical team at Nationwide Children's Hospital in Columbus Ohio.

It is their support and financial backing that we were originally able to move the science forward to the state, I mean they were instrumental in pushing forward our two Sanfilippo programs to where they are today.

As mentioned by Steve Rouhandeh our goal here at PlasmaTech now is to really grow a Company as a leader in the area of gene and cell therapy, particularly the focus on where disease is. The growth from the plasma-based protein replacement therapies which is what we are doing with Alpha-1 for inherited COPD.

The gene therapy is a natural strategic progression from a shareholder and also is importantly from a patient perspective it’s very exciting time to be involved in developing this much needed gene therapies and leveraging our gene therapy experience with what we believe are the best-in-class approaches to treating patients with these rare diseases and we expect to add additional programs into the mix in the very near future.

But it may be helpful to provide just a little bit of background on the originally beyond the programs particularly the condition known as Sanfilippo syndromes and here are our current development programs. Just to give you a little bit history on Abeona. Abeona was founded as the voice of over a dozen international foundations.

There are patient groups with a mandate to find and fund the best therapies to treat their children. With access to global data over a dozen foundations chose to support this approach and our research to treating Sanfilippo.

Sanfilippo is a rare lysosomal storage diseases like 95% of the 7,000 rare diseases there are no cures available for Sanfilippo syndrome.

Historically when you look at the different types of treatment options for comparable diseases mainly enzyme replacement therapies, which can cost upwards of $500,000 per year and there are challenges that are faced such as not being able to cross the blood brain barrier that can be overcome by gene therapy strategies such as the one that we’re using in adeno-associated virus.

So what we’re trying to do here is use this gene therapy approach to cross the blood brain barrier, give these therapies to be able to treat the whole body manifestations including the central nervous system components and currently we have two separate programs that are roughly equivalent in timing and their pathway to clinical trials and we anticipate that are the programs for both MPS IIIA and IIIB will be in the clinic by the end of 2015.

This is we’re planning for success and we identify these additional gene therapies that we anticipate bringing into our pipeline in the near future and how we’re going to develop these gene therapies and develop the Company into a leader in gene therapy globally.

And with that I’d like to turn it over to Jeff Davis who is going to discuss just briefly some of our therapies plasma diafiltration technology..

Sure. I’ll just provide a little bit of update on our program in inherited COPD.

As Steve Rouhandeh mentioned we in-licensed a Salt Diafiltration process which is basically a new innovative process to remove, to extract and purify proteins from human blood plasma in it differences relative to what it’s done in the industry today which is known as the Cohn processes, our process doesn’t use any ethanol and it is done a neutral pH so we have a process that uses two different concentrations of salt, we’ve chosen a salt sodium citrate which is used currently as a preservative in blood products so it is kind of like user-friendly in that manner.

We have two different concentrates to precipitate out the high value-added proteins first alpha-1 antitrypsin which is currently used as replacement therapy for inherited COPD as well IVIG. And so with respect to what we’re actually doing, we have contracted with a Contract Manufacturing Organization, a CMO in late January.

We are in the process of finalizing and optimizing the downstream portions of that process the chromatography steps et cetera, with the goal of having a pre-IND meeting over the next quarter or so scaling up and finalizing the CMC section of an IND filing manufacturing the clinical material with the plan of getting into the clinic in early 2016 and we will discuss with the FDA exactly what our clinical trial program is but we expect it to be similar in size and scope as the recent trial done by Kamada to get their Glassia product which is the last alpha-1 antitrypsin actually approved.

Following that we will look to IVIG and potentially other orphan proteins where our process might have some kind of competitive advantage over the Cohn process. So that is where we are with respect to the inherited COPD program. I thought I might just expand a little bit what Steve Rouhandeh said with respect to our financial position.

If you look on the publicly available Form 10-Q for the first quarter we have approximately $8 million in cash on the balance sheet at that time. As mentioned by Steve we did a $7 million private placement in April.

Followed by a $10 million private placement in May, followed by the acquisition of Abeona which had a cash balance from its raises with the Sanfilippo foundation as well as grants for development.

And additionally we have had approximately $4 million in the exercise of warrants that brought in the cash for warrants from the public uplifting transaction that we did in December. So I'll let you do the math yourself but the previously mentioned numbers that is up to roughly $30 million that’s prior to any burn thus far in the second quarter.

So that’s to kind of give you the background on the financials I guess. Before we open it up to Q&A just from an investor relation perspective I mentioned a few things. We're presenting tomorrow at the MarCom Micro-cap Conference at 11:00 AM Eastern time that’s at the Grand Hyatt Hotel in New York City.

Next week we're at the Jefferies Conference on Tuesday June 6th with 11:30 Eastern June 2nd sorry 11:30 AM Eastern and that’s also at the Grand Hyatt as well as we're going be presenting at the LD Micro Conference out on the West Coast that would be Monday June 1st at 11:00 AM Pacific. I believe that is at the LUX Hotel in LA.

And then upcoming we're going be at the Bio-Conference in Philadelphia where on Thursday June 18th we have a 10:45 AM presentation slide. And most of those conferences is available we will webcast online together with audio and our slides and those will be archived.

So I’d say just as you look to our press releases prior to the conference that will give you more details on those conferences as well as how to get to the links for the webcast. I think with that maybe we will open it up to Q&A. Operator if you provide the instructions and then we can take some questions..

Thank you. [Operator Instruction] Thank you. The first question is from Elemer Piros of ROTH Capital Partners. Please go ahead..

Jeff just one bit of clarification without any additional burden the cash at least according to my calculation is about 35 million is that roughly under the ballpark?.

I think you're in the right ballpark yes..

And what is your anticipated burn rate now that you will start during the next 12 months I think see different clinical trials?.

Right, so this is Steve Rouhandeh at this point we haven’t given sort of formal guidance yet. But I can tell you that just sort of approximations on what you can sort of -- you can kind of add it up from our publicly available statements.

We think on the SDF that’s kind of a 5 million to 6 million more on spend to get it to market from what we spend already. We think the Sanfilippo's A and B could be approximately 5 million each. So we clearly have to get through Phase 1 on each of those.

So we clearly have and we have a fairly modest G&A there are about 10 or 11 employees in the Company. So we clearly have enough money to get to inflection points and probably beyond on our pipeline at this point.

As we've just digested the acquisition and we're going be filing audited numbers shortly and we'll be giving sort of more precise guidance but I just wanted to give you sort of the maybe 30,000 foot but 3,000 foot level on where we're looking, how we're looking at it right now..

And if I may ask Tim if you could talk a little bit about the upcoming Sanfilippo B and A trials. The end times are different but the manifestations of these two conditions are very similar.

Would there be any trial design differences between the two of them?.

Sure, so there will be some small differences. One is first the number of patients that will enroll for MPS IIIB and we will be slightly smaller than the number of patients that we enroll for MPS IIIA, I mean that’s really a function of prevalence in the United States.

So we will enroll six to nine patients for IIIB and nine to 12 patients for MPS IIIA. The designs are very similar from both and our clinical efficacy endpoint measurements and the follow-up timeframes, very similar designs have also been used in the ongoing natural history study.

One of the strengths of this program is really that natural history study being conducted by Nationwide Children's Hospital that has been able to help us Cohn in and evaluate good clinical efficacy endpoints that’s one of the strength of this program going forward..

And what is the status of those natural history studies to what [Multiple Speaker]?.

They have enrolled 25 patients to-date, and 50% of them are through their six month endpoints, 25% of them have reached their one year endpoint.

The FDA is very keen on asking companies to develop natural history studies and they are looking at these rare diseases and have asked for this type of information to be filed as a perquisite for IND filings and so all of this data will be going into our IND filings..

And just one last question about these two conditions.

If I understand correctly, one has a more the faster time course, would that be factored in into your clinical trials as a one potential difference and somewhat related would be ages of these children that would be enrolled be different in the two different studies?.

So one of the things that we've learned through the natural history study is that the progression of these diseases isn't as much a function of age as it is really the manifestations of the disease and we won't be putting an age ceiling on these studies, again looking at our natural history profiles we've been able to demonstrate that these manifestations and how they are looking at, how they are evaluated from a clinical efficacy endpoint standpoint has really been a driver in how we're going to be enrolling these trials and certainly these are the potential candidates to enroll in the clinical trials..

Thank you. The next question is from [Paul Mann of Soros]. Please go ahead..

Just on the trial MPS IIIA and IIIB trials that are going to start later in the year. Obviously it is going to be open label, I am assuming they are open label and so we're going to see clinical data where we're going to see real time results as these trials are ongoing.

So how do you intend to communicate these results to investors because obviously this means information not just how these drugs are looking?.

Sure, that’s a great question. We have some of our -- some of the primary endpoints in these initial trials are safety and we will be able to the data and safety events is s reported to Medline so that will certainly be published information.

As far as efficacy is considered we'll be putting out information certainly later in the trials as we get through sufficient numbers of enrollments after the six month and 12 month endpoints..

Maybe a question for Steve, you mentioned you are looking at other opportunities as well and it sounds like you have got a decent cash balance and have to see through well see the Company to profitability what other stuff you are looking at in-licensing potentially and are there opportunities out there?.

Well I can just tell you so when we came across Abeona we had obviously cast a kind of wide net to move the company into the gene-therapy space, and so we're looking at sort of complimentary things that maybe use the same vector academic kind of collaborations, it's hard to predict what you'll do and you got to be careful about that, so we're not currently planning any sort of large M&A deals like the one we just did, but we're looking for sort of bolt-on and the strategies for bolt-on complementary things that sort of fit right in where there would be synergy and sort of manufacturing and expertise, things like that which we had -- when we went out to look for and found Abeona we had sort of vetteda few of these and they are all just working away sort of through the process at this point..

And in terms of the Alpha and Alpha 1, I think you're expecting to get some data on the manufacturing process at some point and maybe the late first half or over the summer, can you give us a bit on when one should expect that timing in terms of yields and the velocity of the process and so forth?.

Sure, I mean, I think Paul, this is Jeff Davis I think even the process in terms of the optimization of the downstream chromatography is going as expected.

We still believe we'll have some data to talk about before the end of the first half year here and that would be just verifying what we believe are vastly increased yields on these proteins, purity half life some of those things.

We've also as part of that process we're looking at the initial precipitates for these ultra-orphan proteins to see what else is in there where our process may have a particular strategic advantage meaning it has higher yields than the Cohn process or maybe it has commercially viable yields and that would be for some of these ultra-orphan proteins like plasminogen or C-1 esterase inhibitor, anti-thrombin III things like that.

So we have that analysis ongoing as well and so the plan we still to have something to talk about with respect to finalizing that process by the end of the first half of this year..

And if you were to find some ultra-orphan products out of the process, how quickly could you advance those into the clinic obviously the value uplift from that could be off the charts?.

Yes I mean I think we could be not too far behind where we're with our alpha 1 program and there are couple of other comparables out there ProMedic up in Canada where I recall you've spent some time.

ProMedic has talked about in some of their public investor conference saying that they're looking at plasminogen where there is currently not approved protein and where there discussions with the FDA around the clinical pathway forward are quite comparable.

Now I guess to what we've seen in some of the C-1 esterase or alpha 1 meaning you kind of have a Phase I/pivotal single trial with very few patients.

I mean I think the ProMedic -- the ProMedic's last presentation, investor presentation I saw they were talking about Phase I/pivotal trial for plasminogen that would only entail something like 25 patients or something like that. So I think we could move those ahead pretty aggressively..

Okay, great. Thank you..

And I'll just add Paul really those would be in keeping with the strategy you recall as Tim mentioned which is we're looking at -- we're sort of laser focused on rare diseases, so we're quite interested in seeing if any of that, if the process yields anything that's viable or interesting that is a priority at the Company..

Thank you. The next question is from Richard Malinsky, a Private Investor. Please go ahead..

Congratulations on really diversifying this business, but a couple of quick questions on MuGard and ProctiGard, could you give us a quick update on what's going on, on ProctiGard or MuGard and also can you give me a few companies in the plasma space that can we compare evaluations of those companies with what our evaluations is here for plasma?.

This is Steve Rouhandeh, well, there is -- it's a good question. We recently -- the Company has had a little bit of stock run up and as a policy like most companies we don't comment on stock price, but even with our market cap where it is which is slightly over 200 million approximately right now.

If you look at comparables in the gene therapy and I think everybody is aware of who the companies are and what the valuations are they tend to trade from 1 billion to 5 billion maybe pre-clinical to Phase I.

In the plasma space there are not as many peer plays there is three big fractionators that control 16% of the market in the smaller area there is a couple I guess that if you look at our presentation which is on our website.

China Biologics and ProMedic a company Jeff just mentioned and I haven’t looked at their market caps in a while but maybe a month ago they were at a 1.5 billion and 2.5 billion respectively. And China Biologics is a commercial stage company. So it's not quite as comparable.

But I think what it shows you is that, it is from an investment standpoint it's potentially very lucrative space to be in and we're quite happy with our technology.

So I don’t know that were direct comparables to those and answer your question those are couple companies that our Plasma, drives protein companies and or with or without interesting technology..

One last question I see that Novartis is doing a study with your MuGard.

Can you explain little bit about that Novartis how that came about in and why they're doing this?.

Novartis has a oncology treatment called Afinitor which was initially proved for some smaller brain and renal cancers. About 18 to 24 months ago they kind expanded later on refractory breast cancer which -- and vastly increased I would say the potential target population for that drug.

Afinitor if you look in the publicly available clinical trial data like on the package inserts have side effects that they call severe stomatitis which presents a lot like oral mucositis.

And there was a breast cancer doc at the Jonsson Cancer Center at UCLA who try in MuGard with some of her breast cancer patients that were on a drug regimen that included Novartis Afinitor. And she found anecdotally on does patients or so that the patients using MuGard had a significant clinical benefit from that.

And so they approach both Novartis and ourselves about doing a single site randomized and controlled trial looking at patients on that kind of regimen either using MuGard or using some sort of standard of care which tends to be a celine based or bicarbonate rinse based just sort of palliative mouth rinse.

And so both Novartis and our cells and our partner here in the United States now Hanmi Pharmaceuticals agreed to provide clinical material for that trial. That trail started enrolling patients it’s planned to be I believe 60 patients 30 in each arm began rolling I believe in January.

And so should read out I believe sometime later this year although we are not we don’t have sort of real time enrollment data. But I think that could be a significant potential upside in terms of helping with the marketing and commercialization of MuGard..

Great, thank you so much guys I appreciate it..

Alright I think that’s going to be it I think -- we are going to try to keep this to about half and I think we sort of did to the minute.

So I want to thank everybody for their participation and if there were questions that you wanted to ask and didn’t get our contact and information is available on our Web site we're happy to be in touch with investors.

And I think you can look forward to very proactive effort to keep our investors and all our stake holders informed on what we're doing and hopefully you share the excitement that we had a quite a few interesting prospects in front of this and look forward to keeping you updated on that to the rest of the year..

Thank you. Ladies and gentlemen this does concludes today's teleconference. You may disconnect your lines at this time. And thank you for your participation..