Pierre Laurin - President & CEO Bruce Pritchard - COO Greg Weaver - CFO John Maron - Chief Medical Officer

Alan Ridgeway - Scotiabank Neil Maruoka - Canaccord Doug Cooper - Beacon Securities Christopher Lam - Paradigm Capital Derren Nathan - Hybridan Jim Belin - Aldebaran Asset Chris Potter - Northern Border Investment

Welcome to the ProMetic 2014 Third Quarter Highlights and Financial Results Conference Call and Webcast. I would like to introduce Mr. Pierre Laurin, ProMetic’s President and Chief Executive Officer; and Mr. Bruce Pritchard, Mr. Greg Weaver, Chief Financial Officer and Dr. John Maron, Chief Medical Officer. For your information, the presentation will be followed by a question-and-answer period. You can ask a question in the language of your choice. I will now turn the call over to Mr. Pierre Laurin.

Thank you, operator and good morning everyone. As you all know, this presentation does contains forward-looking statements about ProMetic's objectives and strategies and business that involve risks and uncertainties. And on that note I will bring your attention to the agenda on page 3 that we intend to cover. Greg and Bruce will share the third quarter financial update and then we will get on with John and myself covering the plasma and small molecule therapeutics and we will recap with the outlook for the remainder of Q4 2015 but again on slide 4 just a reminder that we have a very, very busy beginning of second half 2015. We have provided again reiteration of strong guidance of revenue 18 million - 20 million. I will let Greg and Bruce spent on that during their presentation. You may recall that we secured ownership of the plasma collection center and Winnipeg that really helped consolidate our strategy for the plasma derived biopharmaceuticals. Plasminogen development program made significant progress during that period. We achieved new milestones with patients, brilliant recovery that John will expand on the expansion of the indication that we promised and we disclosed just few days ago and we will have several slides on that today. IVIG, the IND cleared by the FDA and this program is finally moving forward and PBI-4050 what's to say orphan drug designation in Europe for IPF and successful pre-IND meeting with the FDA with regard to the add on pivotal clinical trial with IPF, we will update all of that during the call as well as the update on the metabolic syndrome Type 2 patient and the CTA that was cleared on MHRA. So lot of material today to cover but let's start first with the financials and I'll pass the baton to Greg and Bruce.

Thanks, Pierre. Good morning ladies and gentlemen. So as Pierre has already mentioned and earlier this month the addition of. Greg Weaver to our executive team as CFO as I change my focus to the growing operational responsibilities of COO. However given that Greg has only recently arrived with us on the team for today's call Greg and I will share the presentation of the financial results. So if we can move to slight six as usual I remind listeners that this part of today's webcast is based on the financial information for the third quarter of 2015 and 2014 as well as on the audited financial statements for the year ended 31, December, 2014. All of these statements have been prepared under IFR S and full financial information for the group can be found online at sedar.com. Finally all sums in the presentation today are in thousands of Canadian dollars except for per share amounts or where otherwise indicated. So let's move to slide 7 and I'd like to begin my financial comments with a review of revenues for the quarter which were $5.7 million compared to $2.3 million in the same quarter of 2014. A more thorough analysis of that revenue reveals that in the third quarter of 2015 $5.1 million was generated from product sales compared with only $1 million from product sales in the same quarter of 2014. As we've mentioned on previous occasions the company's revenues typically fluctuate from quarter to quarter so comparisons are better done on an annual basis to give a more reliable indicator of performance. However and it's clear to see the figures for the quarter reflect our earlier statements about growing underline product sales and I'll comment shortly on the anticipated full year numbers. So since the shift in strategy to focus on developing fewer products for third parties the service revenues have remained broadly consistent year-over-year with 0.6 million in Q3 of 2015 compared to 0,7 million in Q3 three of 2014. In addition there were no milestone or licensing revenues in the third quarter of this year. So turning now to revenue guidance for the full year 2015 we expect total revenue for half two to be in the range of $18 million to $20 million bringing the total forecast revenues for the year to $23 million to $ 25 million. That ranging guidance takes into consideration both currency fluctuations and the fact that certain product deliveries are shared to a very close to the yearend and depending on the actual delivery date will fall either into 2015 or 2016 revenues. It's important at this point to highlight these forecast revenues that will be generated mainly from product sales showing strong growth in that area. And at this time we've excluded the impact on the forecast of any potential upside from business development transactions that are currently under discussion and the reason that we've exclude those are just due to the uncertainty of timing and the accounting treatment of any revenue but some of those may still impact this year. So moving then on to slide 8 and some of the key figures from the P&L for the third quarter, as I mentioned on the previous slide revenues for the quarter were $5.7 million compared to $2.3 million for the third quarter of 2014. Cost of goods sold were $1.2 million for the quarter compared to $0.9 million in Q3 of the previous year reflecting both the increase in product sales and an improvement in gross margins due to the sales mix year-over-year. Total research and development costs were 11.9 million in the quarter compared to 7.7 million in the same quarter of the previous year and these R&D cost have increased over the same period of 2014 mainly due to the increase in clinical trial activity on both the small molecule in plasma therapeutic programs and also due to the recording of expenses from our manufacturing operations in Winnipeg. Administration costs increased in the quarter primarily as a result of increased head count and business support functions together with increased non-cash stock based compensation costs resulting from stock price increases, these effects combined in the third quarter caused 4.1 million compared to 3.2 million in the same quarter of '14. Next financing costs lately were consistent with the lower level of financing and activity undertaken this year. And finally the fair value adjustment on the warrants was zero in the third quarter as these ones were actually converted to an equity instrument in the previous quarter. So that all brings us to the net loss for the quarter of $10.6 million down from a loss of $20.7 million in the same quarter of 2014 resulting in a net loss per share of $0.02 for the quarter on both the basic and diluted basis. That set of results also gives us an adjusted EBITDA loss of 10.2 million in Q3 versus an adjusted EBITDA of 7.4 million loss in Q3 of 2014. So with that point it now gives me great pleasure to hand over the reign to our new CFO, Greg Weaver to present the balance sheet. So, Greg.

Thank you, Bruce, Pierre, John, Fred, thank you very much for this opportunity. I'm going to move you to slide 9 and the key features of the balance sheet at the end of the quarter. Cash stood at $42.2 million compared to $27.1 million at the end of 2014. And our operating using of cash in Q3 was 11.8 million and 33.4 million for the nine months year-to-date. I draw your attention to our quarterly disclosures that the company has at least 12 months of cash liquidity as of the end of the quarter. Accounts receivable next stood at 6.9 million compared to 11.9 million at the end of 2014, the primary reason for the decrease in trade receivables was the receipt of the GENERIUM upfront payment of 6 million in Q1 of this year while it was invoiced and recorded as revenue in Q4 of last year so essentially a cut off timing difference of revenue and receivable book last year followed by cash collection this year. Inventories increased in the third quarter which total 8.3 million and the investment in inventory over prior quarters is indicative of larger volumes of production and upcoming sales and as you can see from a more detailed footnote disclosure in the Q includes growth in both raw materials with finished goods inventories. Moving to capital assets the balance -- it's risen by 3.7 million since the beginning of the year which represents the planned investment in our manufacturing plants both in Laval, Quebec and on the Isle of Man, UK. Intangible assets remain stable at 147 million and includes the 141 million intangible recognized in relation to the acquisition of NantPro in 2014. You may recall this intangible was the result of the business combination accounting which arose in the prior year and was fully disclosed at year-end. Trade another payables are down by 1.5 million at 7.6 million due to normal payment terms, the one of liability of 24.7 million at year-end which is now being commuted to equity earlier this year in Q2 resulting in a significant improvement in the level of the total current liabilities. Long term debt provided by Tom Best [ph] shown here at 21.4 million has reduced slightly this year as a result of the debt modification and the repayment of some debt in exchange for equity subscription back in Q2. Lastly the total deferred tax liability balance is at 33.2 million at the end of Q3, a decrease of 5 million from the year-end 2014 and this decrease relates to recognition of the company's progress pro-rata share of the NantPro results effect on the deferred tax asset. So the company's overall consolidated balance sheet remains strong, clean a solid base from which to continue building and a rich pipeline of therapeutic drug candidates here are supported by strong operations with which we will continue to invest and to that point transitioning to the next slide, slide 10 where we provide a bit of initial color on our clinical trial plans and cost estimates for next year. I will point out these amounts are initial estimates without the precision that will create going forward but for today's purposes provides us a good guide to discussions on our strategic clinical focus in 2016. In summary you can see the various protein programs in the 40, 50 portfolio but important to point out that at this stage we have an active a very active clinical strategy and you can see from these amounts here are not breaking the bank but look very manageable from my perspective. And now in transition. I'd like to hand the call to Pierre and we will move on with the operational details. Thank you.

Thank you, Greg. And indeed as you commented we'll expand a little more detail by detail and line by line later in the presentation on those clinical programs but I appreciate that you bring our shoulders to a sense of reality as I was getting those comments from time to time. Guys you keep pumping good news about the program but how much is this all going to cost and it's quite reasonable indeed. So let's move onto the corporate side of the presentation and let's start with slide 12, exciting times for Plasminogen, several milestones in fact all the milestones that we have set for ourselves for this year have already been achieved and busted. The safety at further higher doses is confirmed that’s on page 12, no drug related adverse events and the follow on PK at the higher those generated result just as expected. So we have confirmation the pharmacokinetic profile by year end as explained expected but more so. In fact and John will speak to that, we were so proud all here and I'm sure a lot of shareholders conveyed the same pride that our establish optimal dose regimen that we've generated understanding and good control after our clinical trial in U.S. has enabled to reverse a very acute medical condition in the German patient. And as I said John will expand on that. Another milestone that we had set for ourselves by year end with the expansion of Plasminogen use to address additional medical indications and then again a few days ago we announced the deal OMNIO and there will be few more slides on that. On that note John, maybe you want to talk to our audience about the German Plasminogen case.

Yes. As you know we treated under an emergency use conditions a very critically I'll 20 month old baby in Germany and this is the first therapeutic use of this agent in man. I have to say it is one of the most dramatic things I've seen in my 40 year medical career. Patient was on a ventilator requiring circulatory support. We gave three doses of Plasminogen and within four days the patient was removed did no longer needed the ventilator. We could see clinical signs earlier that that, fiscus lung secretions were remarkably decreased and the respiratory functions improved again within hours the patient required less oxygen. I think this is N equals one series of a clinical case but very, very dramatic and very, very clear cut clinical response.

Right, well I mean again [Technical Difficulty] major turn situation, as you know, the FDA has agreed to an accelerated regulatory approval process for Plasminogen in the U.S. which means that we have an agreement that so long as we deliver on the surrogate end point that is confirming what dose and dose regimen keeps patient above a minimum threshold, that would otherwise keep the patient out of trouble and that will be sufficient to file BLA but augmenting that data pack with clinical efficacy that dramatic, I don't need to explain that this will had to the case favorably. So I'm very, very excited with this and on that note now I'm turning to the expended therapeutic use of Plasminogen in wound care management on page 14, very, very happy to share what's been almost a year of discussion and negotiation of course but also getting to understand our colleagues now at OMNIO, [indiscernible] and his colleagues who have vast experience on the use of Plasminogen for treating wounds and had filed patents and have published numerous papers on the topic and this was a marriage to be made that is good scientist with extreme good knowledge of how to use Plasminogen in those hard to treat wounds and an industrial partner like ProMetic that has -- there were all too many factor, large quantities GMP Plasminogen getting together to form this alliance. So the deal provide to us IP, intellectual property and you know patent position on existing patent as well as a new patterns that have just been recently filed giving us a proprietary position in the treatment of wounds in most major markets. It's a huge under-served medical situation, you'll see later with the numbers it's staggering but I'll let first the picture speak for themselves let's John why don't you comment on the following slides, slide 15 for example.

Yes, so one picture is worth a thousand words and we have several pictures but I will confine myself to fewer than three thousand words. These again are very, very impressive pictures. They are proof of principle in the human model, patients who have had long lasting wounds have been improved and cured with injection of Plasminogen around the wound every two or three days. First patient, on patient 15, 77 year old diabetic, three years with chronic ulcers on both feet. Three years is not an unusual result for diabetic ulcers. As the slide says the patient was being considered for bilateral below knee amputation. The pictures show you the very dramatic improved healing, one thing to note is this patient as a complication of these foot ulcers had infection in the bone osteomyelitis and that was what was really leading towards the consideration of below the knee amputation, both the wound and the osteomyelitis seem to have been cured with Plasminogen over several weeks. Again something that was three years that you can make disappear in few weeks is very impressive. Slide 16, second patient this was a patient with ischemic ulcers on the legs, bilateral neuropathy due to ischemic long lasting postoperative wounds from attempted repair, not an unusual result and you can say within a few weeks again a Plasminogen injection healing of the wounds completely healing. Slide 17, the third patient I'm going to mention 66 year old female with a nine year wound on the lateral malleals in other words on the outside of her left ankle you can see the improvement again within a few weeks. We put a of 10 kroner Swedish coin there to show you this -- the size of the wound that's about the same size as a quarter and you see there is quite dramatic improvement. The other point that's noted here is vitality in social life dramatically improved. This patient felt unable to leave the house with this very severe wound and is now mobile and able to lead a essentially a normal life. With that I'll pass you back to my friend, Pierre Laurin.

Well John, of course we’re thrilled with the therapeutic figures you confirmed in the Plasminogen decision patients and there is very sensible mechanism of action involving or building the rationale for the use of Plasminogen to treat wounds and we look forward to expand on this in early quarter next year when we will have the Analyst Day and it will give us a better chance to go over a full-fledged presentation on how Plasminogen actually can reverse such situation. But needless to say Plasminogen is manufactured under GMP condition. We're looking to initiate clinical trials in the second half of next year and one may ask why did it take it so long why aren't we starting right now? Well I mean there are some formulation adjustment and some dose calculation required here to make sure that we do it right. There's good hands on experience and we want to use all that hands on experience to design the trial that will satisfy the KOL and the rig later but we're quite keen to come to hopefully the rescue of some of those desperate patients and of course when you look at slide 18 and 19 we're talking staggering numbers. I won't cover them point by point, here you can read them on your own but you’re talking billions of dollars of cost to the health care system and nearly a million patient incidents annually with half of them having hard to treat wound with limited options which basically means leading a lot of them to amputation and it's not the end. A lot of people with amputation actually don't live very long afterward because sometimes they may have waited too long and it becomes systemic. So all in all I can say is that cost of an injection around the wound for a few weeks is going to be much cheaper and much more affordable than the exorbitant costs of managing those wounds right now and that's where I think that ProMetic will make a huge difference not just bringing a therapeutic but bringing an affordable therapeutic solution to non-mathematical need. So it's quite exciting time for Plasminogen more to come as we progress in fact crossing over to the Phase 2,3, 4 the Plasminogen program next year and well in fact I mean in the coming weeks and -- but also eagerly pleased to advance the program in those hard to treat wound patients. Turning to IVIG, not much to say on that one I mean IVIG, clear now is a very happy ending on a long exchange with the FDA finally clearing our pivotal Phase 3 clinical trial in the primary immunodeficiency patients. This is an open label single arm with two cohorts, multicenter study there's 50 adults to be recruited in the cohort 1, and 25 five children in cohort 2, can only start the children after few adults have been. I think it's 20 adults, John? Twenty adults confirm. Our colleagues in Russia, GENERIUM, [indiscernible] will contribute to the clinical enrollment with some sites in Russia as well such that our BLA filing will actually be a BLA that will be eligible for filing in U.S. and Canada, in Europe and in Russia. So expecting completion of this trial in first half of '17. I mean IVIG is one of many mainstream plus [indiscernible] products that will contributed significantly, financially and facilitate the advancement and the commercialization of other orphan drugs. So it's the strength of the PPPS that enable us to manufacture from a single leader plasma several products as indicated on page 22. So on page 22 you've seen that pipeline before Plasminogen now moving further deeper on the clinical program before it reached commercial status. The new indication will cross over to clinical program as we said mid-year next year and the IVIG now is well on its way now that the IND is clear, it's pretty straightforward protocol that we’re following The other program as you know are being [indiscernible] C1 is there is inhibitor and fibrinogen they are on the manufacturing scale up right now getting ready to be collecting data for the stability program and then following the filing the INDs all of those hopefully being filed here such that we can initiate the clinical trial program in the second half of 2016. Perhaps we should switch here for the PBI-4050 because it has a long list of achievements as well in this period. If we go on page 23 and start with the idiopathic pulmonary fibrosis, we’re quite excited about the orphan drug designation granted in Europe, it follows the one that we have already received from the FDA for the U.S. We’ve initiated and they are enrolling patients in the Phase 2 clinical trial initiated earlier this year, in Canada multicenter trial but the highlight I would say excitement for us is probably the successful pre-IND meeting we had with the FDA suggesting that we initiate a pivotal trial immediately in IPF patients in the U.S. and that would end up being an IND filing in the U.S. and Canada but we now have the input from the FDA to have what you would call an add on protocol that is add ProMetic PBI-4050 to patients that has already in control with either pirfenidone or nintedanib and therefore this is I would say an easier trial to exist on and currently join them in [Technical Difficulty] KOLs to design the protocol in the matter of the next week with all the FDA input and so on and expecting the IND submission for Q1 2016. It's important to know when you see all those dates and what happens when you file the IND obviously the FDA has a chance to review it in 30 days but once you know you either have some comments or the accepted as is very unusual to accept it as is but the pre-IND meeting help resolve a lot of uncertainties when you file the IND you already have taken into account A lot of the advice that they have for the company and once the IND is clear then you got to get the sites going and you got to sign contracts with the clinical sides in the CRO and the principal investigators. So there's always a gap between the IND being cleared and the clinical trial started. That's something we were able to mitigate with the IVIG because even though there was a delay in the clearance of the IND we kept growing 12 sites anticipating that the clearance will take place and we're able to manage that in parallel so there's not much time wasted despite the delay of the IND clearance for IVIG. But IPF looking at submission in Q1 next year for IPF PBI-4050 and therefore as Greg indicated in the schedule clinical trials starting and rolling in the second half of 2016. On page 24 for type 2 diabetes with metabolic syndrome, well the Phase 2 trial in Canada is going very well as you know the drug safety monitoring board confirmed safety in the first 12 patients, we’re now at 22 patients enrolled thanks to that expansion enabled by the board that confirm its safety. So mean it very interesting protocol open label which we look forward to examine the fact of PBI-4050 on biomarkers which would help to confirm the translation of pharmacological activity from animal to human so that translation is very, very important because once you have that confirmed you know we have a drug so we look forward to that event to unfold in Q4. We also have great news from the MHRA in the UK, we cleared the CTA for other study in the diabetic patients with multi-organ severe fibrosis. This is also scheduled to start later this year with enrollment in the center in the UK in the first quarter of 2016. The new data presented at the American Society of Nephrology, lot of presentations that were available in the website, seven presentation overall with regard to 4050 and analogs and I will alert you to pay attention to some of those analogs which will probably have a spot on the podium from under arm very soon. But you know more data from Vanderbilt confirming the marked reduction of fibrosis and kidney in a pure fibrosis model. I mean that is a very impressive piece of data that Ray Harris presented that data and again also from [indiscernible] lab more data confirming the dual effect of PBI-4050 both on reducing fibrosis in the kidney but also improving the pancreatic function in those diabetic mouse and again that's very, very unique feature of PBI-4050, it has been shown to show reduction of fibrosis in the absence of diabetes but when you have those two conditions combined the overall conditions of the animal improved dramatically because both the kidney, the liver, the pancreas improved overall. So it's something we obviously hope to emulate in humans and we're excited about the prospect the PBI-4050 in the current metallic syndrome patients in the Phase 2 and of course initiating our program so we were busy with the CKD type 2 diabetes this is something a recurring thing you'll see is comitance of fibrosis and diabetes as a very interesting playground for PBI-4050. So, summary on page 25 of the clinical program we completed both Phase 1 and Phase 1b with no side effects. John, presented at the American Society of Nephrology much more detail, we have a full poster on that, with a lot of detail as you can see. There was no more side effects on the treatment group than the placebo group. It was clear that the drug is extremely well tolerated, another big plus which may seem trivial but it's not trivial is that even if patients have impaired kidney function there was no need to adjust the PK in those patients which means that this facilitate that those regimen and prescription for chronic kidney disease patients for instance. So again the Phase 2 open label for IPF and the metabolic syndrome in Canada both running and enrolling the next step though for the metabolic syndrome, the trial is a preliminary read out early December and he effect of 4050 on metabolic disorder biomarkers and we also have an exciting program to announce soon, a new orphan indication for PBI-4050 and this again will be announced in December when we have wrapped our mind around the protocol that we're finalizing so exciting times for PBI-4050. So, finalizing the protocol for both the new orphan drug indication that we will announcing the CKD with diabetes and IPF add-on protocol so we have a John Maron and his team extremely busy right now but are looking to file the IND with the advice and input from both Health Canada and the FDA with the program initiation early '16. So, and Greg just before and then you can refer back to that slide these two slides again with again an impressive program to demonstrate proof of concept, proof of efficacy and in some cases initiation of the pivotal trials. There are not some of them in diabetes actually they're not invasive, they're not expensive to drive and something that ProMetic \with it's current financial situation can easily handle. So in summary, the key milestones for the second half of 2015 on slide 26 as a means to wrap up this conference call, we provided guidance on the revenue as Bruce and Greg indicated significantly relying on product sales. So these numbers are pretty solid. As we have the P&L, we're delivering on it, these are number and the inventory increasing indicative that there's a lot of products to ship in Q4, and Q1. So that's good sign because the base business is growing and it's solid, there's also business development transactions that are expected closing and recognize this quarter, next quarter, the point is that there's more cash coming in from business transaction but there's also other contributions from those deals as you can see the deal with OMNIO didn’t provide cash obviously but provide a good complimentary know how and intellectual property that helps us advance further the potential use of Plasminogen as a therapeutic. We have promise and we will disclose a new orphan product coming out of PPPS cascade, this is also before year end and we're busy manufacturing all the products but including Alpha-1 inscription, the C1 if there is any better and the fibrinogen we may not be press releasing every time we successfully scale up one. At one point the company is maturing that is not going to start talking about every process it can achieve in the manufacturing plant but let's put it that way, the program is running well between [indiscernible] and Laval and Winnipeg, the [indiscernible] is working extremely well and we are going to be filing INDs in 2016 to enable those products to join the bang and have more in the pipeline. PBI-4050 preliminary readout, that's a date you will not want to miss. We all are looking at the screen at the same time to see 4050 performance in the first 12 patients of that metabolism syndrome patient study and why not a new orphan indication for 4050 to be announced. So I would say that between now and Christmas we’re busy, more to come, exciting year so far and good prelude for an exciting 2016 on that note operator I will open the floor for questions.

[Operator Instructions]. Your first question comes from the line of Alan Ridgeway from Scotiabank. Please go ahead.

Pierre maybe I will start with the new OMNIO indication the wound healing. Can you maybe just provide us with a little bit -- so I think you guys mentioned a few times that this healing is taking place over a few weeks after years of having these ulcers. How is Plasminogen being dosed during that time? Are we talking about multiple injections on various days or weekly or how is that being given at this point?

Alan, as you can appreciate the pictures that are shown here were done on a compassionate use and the dose regimen use have not necessarily have the optimal compliance of nurse going every day and so on so I think that what will happen here that we have learned from the experience of our colleagues in Sweden will factor that in into the protocol. We are running order experiments to optimize that dose regimen. But I would say that you know just for indicative purposes let's put it that way don't hold me to it because there's still optimization and still some thinking around that but we are looking at a regimen that will look like injections every second day for about a month to resume significant wound and it's been done before and here what's impressive it's been done in humans right. And the logic and the mechanism of as you know is quite straightforward. Counter-intuitive I would say but quite straightforward and you know the marriage between the ProMetic and OMNIO are making a lot of sense.

And you mentioned having to maybe tweak a little bit on formulation, can you just comment on maybe the extent of what work needs to be done there from a formulation perspective to get this into the injectable form? Are we just talking about finding the right concentration or is there going to be some other components of the formulation that needs to be worked out?

We have done that work in the background. We have done the work. We already have the formulation except that you know typically when you file an IND you already have to have the stability program in the vile. So we have been busy focusing on the IV formulation and this is the one that is in patients right now but it's the same API, same Plasminogen API. You don't worry too much about concentration per NL [ph] when you inject IV it's a slow infusion when you start injecting microvolume intradermally around the wound then the higher concentration the better within reason. So there's some optimization there but we have a very good range and we have formulation developed already. So it's a matter of the clock ticking to accumulate the stability program before we can officially file the appropriate formulation for those type of clinical indication. There is no -- I will put it R&D riskier, it's more just like picking the box and getting [Technical Difficulty] for the filing.

Okay. And maybe my last question I will jump back in the queue. What do you think the full clinical program for this indication might look like? How big might the first trial be and then what type of trials would you potentially need to run following that one to go for an approval and wound healing?

Well it's a good question that we actually cannot comment right now. We will learn a lot sitting down with the regulators, this is rather unusual situation, we have a very well characterized product, it's a single protein doing its magic. Plasminogen is well known plasma derived protein doing it's magic. We know it's key role in the wound healing process. This is an API that most likely as we get into the wound healing patients will already be filing a BLA for the treatment that’s systemic wounds, think about it. We have patients who will have now wounds in the lung, wounds in the various part of their body and we will have an API authorized for use in human injected intravenously and all of a sudden we're expanding it's use for the treatment of topical wounds. So what kind of regulatory process will be allowed? Are we going to face again a potential accelerated pathway here? I don't know. There's been failures in the attempts previous attempts to treat diabetic for the ulcers but these were novel treatments and so on here we're talking about expanding the use for an API that would most likely already be approved for use in human systemically. So it's a question I look forward to update you all at Analyst Day once we have had the chance to get some feedback from the regulatory agencies on that.

Your next question comes from the line of Doug Miehm from RBC Capital Markets. Please go ahead.

It's Joel on for Doug. Just wanted to ask quickly have you had any more contact with the FDA regarding Plasminogen as it relates to the acute treatment of Plasminogen deficiency?

Well I mean this type of program when it's an orphan indication is one where there's more open dialogue than unusual. I think that where we're in a position where right now we're gathering data on our U.S. patients, the German patients, our colleagues here on the line they want to comment on this. John, is trying to package this as neatly as possible but you know we have a very interesting position here where we are authorized to file a BLA without any evidence of clinical efficacy. I appreciate that people are wondering now that you have clinical efficacy and equal one and possibly will have more than an equal one by the time the trials are all done what difference does it make in terms of the filing and probably not much the point is that we're looking at file a BLA next year and be in market very soon, so that's quite fast for a biopharmaceutical anyway. But you can imagine that the data for the German patient will be used with the filing with the FDA that's for sure.

And one another question, just wondering if you had any specific plans for the center of excellence that you’re going to be operating in Sweden?

Well again I don’t want to make this sound as a huge expense, this is something that we can afford and instead of reinventing the wheel in our labs here. We saw a great an opportunity to have a collaboration with savvy seasoned scientists that knows more about Plasminogen that many labs put together including ourselves and was easier much more sense and actually quite conceivable to have that relationship with our R&D pursued there, [indiscernible] studies supporting the IND filing. There is a lot going on, Plasminogen is involved in so many different ways in the treatment the wounds both in anti-body and on the surface. So this is a great addition to our capability and understanding of Plasminogen overall. So that's what we're funding and leveraging our knowledge, understanding of this fantastic protein.

Your next question comes from the line of Neil Maruoka from Canaccord. Please go ahead.

Just a follow up on the Alan's line of questioning, can you let us know how many patients you have data for in that proof of concept data set for Plasminogen?

There is nine patients.

Total nine patients, and do you think that based on this and the unmet clinical need that there is a chance you could move this directly into a pivotal trial in diabetic ulcers?

Well quite frankly I wouldn't go there Neil, if anything establishing an optimal dose regimen is very important. I mean I think that we want to understand what went wrong with other trials and we want to make sure that we've totally optimized the protocol. To make it as simple as possible and so we’re proposing here as a first trial going in it's certainly to repeat what's been done using our GMP product you know establishing evidence of frequency of injection and quantity to be injected, is there instance more accelerated versus not these are some questions asked by the regulators and we will ask those questions to ourselves in our key KOL studies. So I would say that the pivotal study is something for '17, you know at one point we have a better hands on experience with our Plasminogen and compliance on the dose regimen that is fixed in the protocol and then that becomes a protocol that we rollout in your pivotal study. But indeed if we repeat the reversal of those very old wounds and wounds that are in patients that were otherwise meant amputation it could very well be that there is a special treatment from a regulatory point of view for those. So we'll go step by step, it's rather usual situation to have again a drug that is technically would be otherwise approved for systemic use and now you're going into intradermal injection on a smaller scale so from a regulatory point of view you’re exposing the patient to a far lower dose in the systemic use for a very localized wound. So we'll try to leverage all this more importantly let's understand what's the optimal dose regimen here to achieve the fastest result, but as you can see its quite evident all those John presented and six others, they were all old in some case [indiscernible] ulcers, pressure wounds but old.

Okay. Switching gears a little bit your PPPS process is optimized for several drugs and many of which are not yet announced, what are the hurdles to announcing those additional plasma drive orphan drugs? Are you looking for partnerships? Do you’ve big pharma interest?

Well Neil, just look at the OMNIO transaction, right. It's one that actually you have -- in almost a period of a year we've been working with the principle that OMNI and [indiscernible] to understand how we could jointly advance the knowledge of the science around Plasminogen, how we can structure a deal such as that everybody is happy, they had patents. We found ways to file additional patents and you know you don't want to go ahead and announce something until all has done. So we always said business development deal around PPPS derived proteins would be the type that can contribute financially, can complement known how or add intellectual property or provide access to market. If you look at the deal that we had with GENERIUM not so long ago we access Russian CIS market but there's also complementarity financially, they also fund clinical trials. They have a great understanding on [indiscernible] and they are advancing products that we had no -- we are to advance ourselves. If you look at the deal with OMNIO, okay, they don't contribute financially but they provide us access with patents that now makes that plasma derived product proprietary and we will have with the new patents filed with them 20 odd years of exclusivity globally, right so this beyond now orphan this is global patent protection for a million patient base indication. So this is why sometime we are well aware of what we're going to do, but we're waiting until an agreement of the kind is done to [Technical Difficulty] and that both party intended to get together to do something together in the best commercial position. So OMNIO took a year to close and set the stage and during that time it's good that we progress our Plasminogen to a level now where we can enable that program efficiently. So that’s in a nutshell two examples of why, but there's more to come and we're going to announce another one before year-end.

Okay. And maybe a near term revenue opportunity, fibrinogen in non-pharmaceutical use, are you close to a commercial agreement there? Do you think you can start selling that product before the end of the year?

Well we’ve made progress with many parties and not all of which we can also disclose for various reasons. So it's like we’re looking at this as an interesting business line for us, fibrinogen has and will have it's own future as a therapeutics as we announced. So it will get into its own pipeline. It's going to be an interesting proof as you say with potential sales without being regulated therapeutic but we’re making progress and again some restrictions as to what we can disclose for the time being but it's progressing pretty well.

Your next question comes from the line of Doug Cooper from Beacon Securities. Please go ahead.

Just on the product sales first of all, do you’ve any more color around that, is that not going to clients or pharma companies who are beyond clinical trials and actually into commercialization? I guess I'm just trying to get to is this level now where we can expect this kind of sales or is this still a sort of lumpy 18 million to 20 million in the second half, is that something that will continue into 2016?

I think I think Doug the answer is that we're certainly getting closer to this being more linear but it is still lumpy. What we're what we're seeing in the latter half of this year are deliveries against some orders that we received early on in the year where our clients have asked us to hold back and deliver at the back end of the year. And some of the deliveries relate to marketed products, some of the deliveries relate to products that are in late stage clinical. I think as we get through 2016 and into 2017 that’s when we're going to be in a position to see this leveling out more regularly.

Pierre, can you maybe just remind us the commercialization timetable, I think you said you’re hoping to file BLA for Plasminogen in 2016, is it commercialization I think in 2017 and IVIG noted here I guess the clinical trial going into 2017, is that a 2018 commercialization kind of thing or?

That's the way we are looking at it right now. It's like a fairly well sequence program where as you just mentioned looking at Plasminogen that will be used on the compassionate use because those patients that are on trial and actually relieved are going to be kept on the drug until approval and -- so where we're looking to have a rapid review by the FDA on this type of drug and definitely '17 is a year where we would have a commercial product for almost a full year and then follow the year after by IVIG and Alpha1‐antitrypsin will kind of be very close timing. So sequence of products 17, 18, 19, by 19-20 you’ve have now five or six products contributing to the top line bottom line. So this -- is as you well know the model explodes to rather insane numbers but Plasminogen by far will have the potential to drive far more revenue than everyone anticipated here, and genital [ph] is an interesting market but it's pale in comparison to the wound care healing.

Just on the would care and then I'll jump back in the queue, but you know it's early days but just in terms of your preliminary thoughts on distribution of it and pricing?

Well it's a good point, Doug I mean we said all along we cannot be the best party to commercialize everything we can make, right. So we were okay to market products that are for orphan indication where you're looking at 4050 teaching hospitals in the U.S. for example which treat most of the patients with the Plasminogen deficiencies. That is something ProMetic can handle, when you get into a success story with the treatment with wound healing that may require a partner that is already well established in this, we could indeed have commercial partnership that would help us reach deeper in that market. This is to be evaluated as we go along. We just disclosed right now one of the wound that Plasminogen can address, the patent covers more and we'll address this internally as to see what makes sense to pursue as we go alone. So it's very, very interesting when you can have a single API manufacture in the plant that can explode into different medical indication. But we may not be the right party to commercialize them all. So stay tuned for that, I mean that's pretty clear in our mind, right?

Right. And I guess just -- I just lost my train of thought there, this is I guess recurring way -- if you cure the foot ulcer the diabetic patients still prone to do more in the future, correct?

Yes that’s entirely correct and in fact one of the patients did relapse when the Plasminogen was stopped and had to be restarted again. So we’re not curing the diabetes in this particular case, we're just dealing with a wound and because diabetes is a systemic disease affecting many parts of the body. We can expect that we will be treating the same patient for different wounds.

Your next question comes from the line of Christopher Lam from Paradigm Capital. Please go ahead.

If I could just jump to slide 12, the first three bullets regarding the safety confirmed at a higher dosage and the pharmacokinetic profile. Has this been confirmed in a second cohort of the Phase 1 trial and can we take this as a sign of completion of that Phase 1?

It has been done of course in the quarter two and there's always a delay between the final reports and everything and some preliminary, this is an open label trial right, so what I'm reporting today is that the PK is confirmed higher dose but not only that, Chris, I mean this is the basis of which we used to tweak the German patient, right. So it was already with good insight of the cohort 2 PK that John was able to work with the German medical team and achieved this kind of miraculous turnaround. So if it hadn't been of cohort 2 we would have of dabbling around the dose but cohort 2 really affirmed up our understanding of the PK and the dose that you achieve in the plasma level and it all worked well as you can see.

Absolutely. Okay, and just one last question on the OMNIO patients. In terms of the source of the Plasminogen, can you just confirm was that that product made by ProMetic?

No. this has been done on a compassionate basis by OMNIO over the years and they were using a Plasminogen made locally. We during the phase of mutual due diligence we confirmed that our Plasminogen behaves the same way, performed the same way and of course going on this is going to be a GMP product from ProMetic now, but we know that the characteristics of our product emulates the one that OMNIO was using in the past.

And then just lastly actually on the OMNIO patents, you touched on a little bit. Would you be able to provide a lot more details in terms of what those patents protect, is it the injectable formulation and potentially number of indications that you’re looking at going can transfer [ph]?

Well these patents are public domain information, they cover multiple different type of wounds and they cover different type of administration. They also cover, the plasma derived form so they are quite wide and we have layered additional claims since and these are not published. And these few patents are far more precise to methods that’s used Plasminogen is too specific embellished by our own data and OMNIO data they have never been published before. So there is the patent the family that has been published plus the one that we filed recently that will not be public until a year and half ago, that will cover the entire patent state and probably more as we go along with OMNIO.

Your next question comes from the line of Derren Nathan from Hybridan. Please go ahead.

Part of my question was just answered there about the source of the Plasminogen but following on from that I think as I’ve it correct, there wouldn’t have been any other alternative for them to do this sort of trial on a mass basis, as far as I understand you’re the only GMP source of Plasminogen out there at the moment. And also you know any -- will have a much better yields than any other methods, that’s my first question.

No, you’re absolutely correct Derren. I mean this was as we say it, this was written I mean these guys in Sweden they know their stuff but they didn't have the industrial capabilities and as much as we know a lot about Plasminogen we have learned tremendously and will continue to learn about the aspect of Plasminogen and those topical wounds and that partnership makes the whole thing possible.

And then just on a business development, clearly there is quite a lot of stuff that could fall in the next six months which is why it's a bit of a timing issue for the year end. Can you give any idea of the sort of scale of the short term deals you’re looking at in comparison to your other revenue sources?

I can't really comment because they're like material in size and range. And there are certain things you know that we may put the pen down because we're getting data from our own trial and all of a sudden they are oops, that change the number. So it is a bit premature to comment on that but let's put it that way I believe the company is again in a position to enter into agreements that would keep on maintaining or strengthening its balance sheet and enhancing it's pipeline. And I think we’ve demonstrated that in the past and I think that as we advance the assets in the clinics the odds, probability of being able to achieve same or more is increasing. And as the asset gets de-risked, value goes up. So I think we're heading in that direction.

Your next question comes from the line of Jim Belin from Aldebaran Asset Management. Please go ahead.

The success in treating that German child makes all of us especially proud to be ProMetic shareholders, my involves Plasminogen, by January 1, 2017 how Plasminogen can be produced by the current manufacturing capacity and how many patients diabetic patients could likely be treated by that amount of Plasminogen that you produce?

It's an interesting calculation but if you do and believe it's going to be on the script, if you do a back of the envelope calculation a small napkin with a rough spend you would probably with current capacity in Laval and Winnipeg 200,000 patients. So if you do the math and you know that these patients really cost so much money and you just apply $10,000 per treatment patients which is not exorbitant if you can save them from being amputated. You’re looking at an interesting line just with our existing capacity and that existing capacity will not remain static as you know, there is partners that are already building our next webcast will share pictures of where the GENERIUM plant is that in terms of construction, pretty impressive. But to your question with existing capacity 200,000.

My question is, you said that you have enough cash for the next 12 months, my concern is you have so many things going on if there happens to be a delay in the timeline and the cost of some of these trials are slightly more than expected. I'm worried that you may have to go back to the market sometime in the next twelve months before some of these other revenue sources kick in. How likely is that?

Well. It's a good question. I will let Greg and Bruce step in after I make my opening comment is that we’re doing everything possible here to align ourself up to a NASDAQ listing. The optimal timing for us as you can appreciate having brought our pipeline to more maturity and have more clinical evidence of efficacy on our two lead products, Plasminogen and PBI-4050 which I believe should drive the value of the company and also attract many new investors as well which were all in the queue waiting for this to be confirmed. We have deals that can embellish the balance sheet overnight as you know and one wouldn’t do a NASDAQ listing without considering doing an issue as you list. So these are all things in the work. I'm also reminded by our CFO that there are some warrants that will come to their like well in the money and they will come into pressure for exercise by the time we're talking about and that adds another $20 million - $25 million. So there is all kinds of things that can come the way of ProMetic and keep the balance sheet very strong. So it's not a given that you have to turn around and I mean the point of Greg's slide initially right at the financial section was to show that, yes there's a lot of program going but we have not opened the gate to very large expensive clinical trials. That will come as we progress and that will then be addressed with a stronger balance sheet either enable through partnership or as we list on NASDAQ. But that's for later in the year '16.

I just would add that in large measure as -- our business model based upon joint ventures partnering alliances and there's a history of that activity here, a very positive way and so to the extent the non-dilutive funds can be put to use here to drive this clinical strategy that's where we'll be focused. This is all in addition to what Pierre just laid out for you as a pretty comprehensive answer so it's not much for me to head without being redundant except to say that we will as all shareholders here, we will do the right thing. I will leave it at that.

Your next question comes from the line of Chris Potter from Northern Border Investment. Please go ahead.

Can you elaborate on what the economics of using Plasminogen for wound healing might look like relative to for plasma deficient patients, in other words there is a unit of Plasminogen used for wound healing more valuable to you than for other indications?

I think if we use -- again back up the envelope calculation that an $8000 to $10,000 cost to treat a diabetic wound healing for a month, it's quite compatible to the annual treatment of a congenital deficiency patient on an annual basis. So you know that was another big reason for us to move forward with that indication is that there are quite compatible price wise because one is an acute use of a low dose and the another one is a long term lifetime use and to put it bluntly they're quite compatible. So it gives you an idea that you know in a congenital treatment of the kind is going to be in the range of $50,000 - $60,000 per year and it's all subjects to health economics. If you take a patient like the German infant, who has been four weeks in the ICU with extreme cost to the health system and most patients in the clinical trial in the U.S. who have undergone dozens and in one cases of hundreds of surgery that's how those products end up being priced.

So I'm not sure, I follow, you’ve talked about getting $500 per liter for your Plasminogen does that -- will it still be $500 and you will be processing more liters over that $500 number change as a result of this new indication?

If we use the back of the envelope calculation I just provided the number is just shifted to more closer to 5000 per liter.

And are you concerned that the wound care market is so big and that other people -- other processes can produce Plasminogen that you will invite more competition because of this?

Well I mean they'll have to wrestle with patents, that's the whole point. I mean if people want to make their own and want to in-license rights from us because we really strictly cannot supply the world and there will be a great problem to have. This is where sub-licensing rights to enable more patients being treated would be ethical and quite economically sound for us to do. But that would be an amazing problem to deal with, but we have the ability to partner and enable others to use our platform technology under license to manufacture more. The answer to the previous questions about capacity is really restricted the Laval and Winnipeg facility when you start adding other facilities with PPPS efficiency that’s the whole point. I mean nobody really will be able to rival with our platform. You got to use our platform to make efficient Plasminogen otherwise you’re wasting your time. And on top of that you will be infringing patents. So we’re in a very good position with regard to Plasminogen and it's therapeutic use even in large equations like that.

There are no further questions at this time. I turn the call back over to the presenters.

Well thank you very much for all your questions and we’re very excited also extremely proud to be shareholders of ProMetic and it's nothing as I mentioned before more grateful in life to actually be working in a company like this that will reward those who sponsored the program and relieve patients that are facing the wall and looking at no more options. So this is an amazing opportunity for us. We’re all trying to do even more than that and we look forward to the next webcast which shouldn't be too far from now updating you guys on further programs. So look forward to the next one. Thank you again.

This concludes today's conference call. You may now disconnect.