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EARNINGS CALL TRANSCRIPT
EARNINGS CALL TRANSCRIPT 2017 - Q1
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Executives

Stephen Yoder - President & CEO Lance Thibault - Acting CFO.

Analysts

Michael King - JMP Securities Hartaj Singh - Oppenheimer & Company Boris Peaker - Cowen & Company.

Operator

Greetings and welcome to the Pieris Pharmaceuticals Incorporated First Quarter 2017 Earnings and Corporate Update Conference Call. At this time, all participants are in a listen-only mode. A 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 your host, Mr. Lance Thibault, acting Chief Financial Officer. Thank you, please go ahead..

Lance Thibault

Thank you, and good morning everyone and thank you for joining us here at Pieris Pharmaceuticals for our Q1 2017 earnings and corporate update. We announced our financial results yesterday evening, March 10, 2017, after the market closed for the first quarter and three months ended March 31, 2017.

You can access our press release on our Investor Relations page of our website at www.pieris.com. In a moment, our Chief Executive, Steven Yoder will get into the business update but first the following statement.

In compliance with the Safe Harbor provisions under the Private Securities Litigation Reform Act of 1995, I'd like to caution that comments made during this conference call by management may contain forward-looking statements that involve risks and uncertainties regarding the operations and future results of operations of Pieris, including statements related to the timing and progress of our clinical and preclinical trials.

Actual results or events may differ materially from results or events discussed in the forward-looking statements. Factors that might cause such differences include those set forth from time to time in the company's filings with the SEC, including without limitation, the company's Form 10-K, 10-Q and 8-K.

Furthermore, the content of this conference call contains time sensitive information that is accurate only as of the date of this live broadcast, March 11, 2017. And Pieris undertakes no obligation to revise or update any statements to reflect events or circumstances after the date of this conference call.

With that, now for Steve for a business update before I get into a brief summary of the financial results for the first quarter for you all. Thank you..

Stephen Yoder Chief Executive Officer, President & Director

Thank you, Lance and thanks to everyone today for joining us for our 2017 first quarter earnings call.

Pieris Pharmaceuticals is a clinical stage immunology focused organization pioneering the development of next-generation targeted protein therapeutics called anti-calins which share many desirable properties with antibody therapies, yet have unique advantages that enable them to be used in ways that antibodies cannot.

At Pieris we are exploiting these advantages to develop proprietary drug candidates across a range of diseases in our two primary therapeutic focus areas of immuno-oncology and respiratory diseases, while having also developed an innovative therapeutic candidate for anemia.

Our portfolio of innovative drug candidates continues to be developed using our proprietary anti-calin drug discovery platform which is protected by an extensive suite of issues and pending patents, and which has been validated through a series of strategic partnerships but also served as a source of non-diluted capital to fund our operations.

The first quarter of 2017 was highly productive, marked by a transformative global strategical co-development and co-commercialization partnership in January in the immuno-oncology arena which branches second largest pharmaceutical company, Servier, which was followed a month later by a Japan focused partnership with ASKA Pharmaceuticals on Pieris's most advanced program PRS-080, a drug candidate addressing the specific parts of anemia.

These very different partnerships demonstrate our commitment to becoming an immunology focused on fully integrated biotech company at the Servier alliance provides for fully retained commercial rights in the United States for several immuno-oncology programs while the ASKA partnership demonstrates our commitment to carefully divesting assets outside of the immunology space.

As part of our commitment to focusing on both immuno-oncology multi-specifics and inhaled anti-calin based proteins to address respiratory diseases locally, we were thrilled to have more recently entered into a global strategic co-development and co-commercialization alliance to address respiratory diseases with AstraZeneca just last week.

We expect these anchor partnerships with Servier and AstraZeneca will not only enable but also accelerate the transformation of Pieris Pharmaceuticals into a fully integrated drug development organization, with clearly defined path to commercialization in immuno-oncology and respiratory disease.

Altogether, the success-based milestones from our existing partnerships including those with Roche, Daiichi-Sankyo, and Sanofi could total more than $4.5 billion plus royalties on sales by our partners. Moreover, both the Servier and AstraZeneca alliances provide opportunities for direct sales by Pieris in the United States.

Also importantly, the three partnerships consummated in 2017 so far has yielded approximately $80 million in upfront payments extending our financial runway through a series of critical value inflection points while neighboring materially increased investments in our proprietary pipeline based not only on the corporate milestones achieved to date but also the additional quarter milestones we intend to achieve later this year.

We continue to believe that 2017 will be the most value creating year in the history of our company. More information on our partnership with AstraZeneca is contained within the conference call week late at May third [ph] and can be found on our website.

Next, I'd like to provide you with an update on the advances within our product portfolio, both fully proprietary and under co-development with our diseased focused anchor partnerships with Servier and AstraZeneca, as well as to provide you with more details about these partnerships and with ASKA for anemia.

Turning first to immuno-oncology, our primary therapeutic focus is on unique immuno-oncology multi-specifics.

Our lead programs, PRS-343 is a bi-specific fusion protein made up of two parts, a monoclonal antibody that target a clinically validated protein on some tumor cell services called HER-2 and an anti-calin that targets the T-cell co-stimulatory receptors CD-137 also known as 4-1BB and which is expressed on the surface of T-cells within the tumor microenvironment.

The advantage of this bi-specific approach is that we can activate T-cells within the tumor microenvironment and direct their activity to HER-2 positive tumor cells for effective tumor killing without unwanted T-cell activation in healthy tissues which we believe could lead to systemic toxicity seen with conventional antibodies.

Last month we presented data informing the design of a first in-patient clinical trial for PRS-343 in a poster session at the Annual Meeting for American Association of Cancer Research, AACR.

These data show that PRS-343 elicited robust T-cell activation when engaging HER-2 on the surface of cell lines resistant to receptive therapy, also PRS-343 was well tolerated and led to no significant findings in IND enabling preclinical safety and non-human primate toxicology studies.

These data reinforce and extend upon the in vivo preclinical data previously presented at CRI's Cancer Immunotherapy Conference last December which showed that the treatment of animals carrying HER-2 positive tumors with PRS-343 resulted in a dose-dependent increase in the frequency of tumor-infiltrating lymphocytes, as well as a strong in addition of tumor growth but having a reduced systemic toxicity and a higher efficacy in comparison to the conventional anti-4-1BB antibodies.

PRS-343 remains on-track to enter a Phase 1 multi-ascending dose study involving HER-2 positive solid tumors representing unmet medical needs such as breast cancer, intestinal, and bladder cancers in the first half of 2017. Pieris as a reminder owns full global commercialization rights for PRS-343.

Beyond this immuno-oncology, in January as I mentioned Pieris announced this transformative global immuno-oncology partnership with Servier to join the pursuit up to eight bi-specific therapeutic programs including our proprietary dual checkpoint inhibitor PRS-332.

PRS-332 is a novel bi-specific comprised of an anti-PD-1 antibody genetically linked to an anti-calin protein targeting an undisclosed checkpoint target.

Under the financial terms of this alliance, Pieris received an upfront payment of approximately $31 million and stands to receive upto $1.8 billion in success based payments in addition to upto double-digit royalties from the potential sales of products by Servier.

Pieris and Servier will jointly developed PRS-332 and split commercial rights geographically with Pieris retaining all commercial rights in the United States and Servier having commercial rights in the rest of the world.

Pieris has the option at a predefined time point to co-develop and retain commercial rights in the United States for upto three collaboration programs beyond PRS-332. Finally, our first immuno-oncology partnership, a collaboration with Roche announced in December 2015 continues to advance.

Under that collaboration, Pieris is developing anti-calin proteins specific for different epitopes on an undisclosed immuno-oncology immune checkpoint target. And Roche will be responsible for the development and worldwide marketing of any resulting product.

This collaboration leverages our capability to address a target in multiple ways through anti-calin based drug candidates in different multi-specific formats and it has a total milestone potential of approximately $400 million, as well as royalties upto low double digits.

Turning to our second therapeutic focal area which is the deployment of novel inhaled anti-calin based therapies for respiratory disease including asthma.

We want to highlight here that our lead respiratory program, PRS-060 is an anti-calin that's differentiated from the standard-of-care and emerging standard-of-care on several important levels which includes this inhaled mode of delivery and it's mode of action involving the inhibition of the inflammatory effects of both, of the T-side occurrence in the T2 pathway IL-4 and IL-13 that activate a clinically validated receptor on the surface of respiratory cells called IL-4 receptor alpha.

PRS-060 represents a first-in-class inhaled treatment for uncontrolled asthma that is based on IL-4 receptor alpha blockade.

There are several clinically and commercially important advantages of an inhaled therapy for asthma over subcutaneously administered antibody approaches and these include the potentially fewer systemic side-effects, increased patient convenience and compliance given the inhaled drug administration a significantly lower dose and a lower cost of goods.

PRS-060 currently is an IND enabling studies and we expect to initiate a first-demand clinical trial in the second half of 2017. We believe PRS-060 targets a very large potential commercial opportunity of $20 million patients globally.

Last week strategic alliance with AstraZeneca, a global leader in respiratory disease, leverages the expertise of AstraZeneca in the area of complex formulations and inhaler devices for respiratory diseases, as well as their global commercial capabilities.

Under the terms of that agreement, Pieris will receive $57.5 million in the upfront in near-term milestone payments and upto approximately $2.1 billion in total success-based payments across upto five programs, including PRS-060, as well as royalties from future sales.

Pieris is responsible for advancing PRS-060 through a Phase 1 study in healthy volunteers which will be funded by AstraZeneca.

Following the completion of this first -- of the first proof-of-concept Phase 2a study trial in asthma patients which would also be funded by Astra Zeneca, Pieris may then exercise an option to co-develop this program in the United States.

And doing so would afford Pieris's increased royalties, [indiscernible] or a gross margin share of future sales depending on the level of co-development investment. If Pieris chooses not to exercise its co-development option, then Pieris will be eligible to receive royalties from future sales.

Pieris separately has an option to co-commercialize PRS-060 in the United States. And beyond this program the alliance includes four, as yet undisclosed novel programs. Pieris will be responsible for the initial discovery of novel anti-calin candidates for these programs after which AstraZeneca will take the lead on continued development.

Pieris has an option to co-develop two of these programs at a predefined preclinical stage and will also have the option to co-commercialize these programs in the United States.

Astra Zeneca will be responsible for development and worldwide commercialization with any programs for which Pieris does not exercise its option to co-develop and co-commercialize. And under this condition, Pieris would be eligible for royalties from future sales.

So beyond these two areas I would now like to provide an update regarding our partners and proprietary programs outside of immuno-oncology and respiratory disease.

Under a collaboration initiated in 2010, and then extended in 2013, Sanofi is developing a toucher-specific fusion protein comprising four distinct anti-calin proteins, each targeting one of four different families of siderophores from Pseudomonas aeruginosa collectively engaging 20 targets.

This drug candidate continues to move forward and is currently in the IND enabling stage. The next update I'd like to provide is for collaboration with Daiichi Sankyo who partnered with Pieris to research, develop and commercialize two anti-calin therapeutic programs beginning in 2011.

The first therapeutic program is an anti-calin protein targeting PCSK9, also known as DS-9001A. Daiichi Sankyo completed a Phase 1 single dose [ph] study in healthy subjects for DS-9001A in 2016.

The results of this Phase 1 study showed a favorable safety profile and also demonstrated a DS-9001A as a potent inhibitor of PCKS9 as the drug candidate materially decreased LDLC levels in Phase 1 study of the subjects at levels similar to those observed with the marketed anti-PCSK9 monoclonal antibody.

With the evolving regulatory and commercial challenges for this class of drugs however, Daiichi Sankyo provided notice to peers this past Monday, May 8, 2017 of its decision to terminate this program for strategic and commercial reasons.

In connection with the terminations of the development of DS-9001A, Pieris has full reversion rights for the program. As part of the reversion process Pieris could diligently review all clinical data and will thereafter consider its strategic options.

With our dedication to the immunology related areas of immuno-oncology and respiratory diseases, Pieris does not plan to advance DS-9001A as part of its proprietary pipeline. We will however diligently assess whether an out-licensing campaign for this asset is warranted.

I'd like to emphasize that Daiichi Sankyo's termination is only with respect to DS-9001A and that the collaboration agreement remains in effect for the second anti-calin protein against an undisclosed target.

Pieris previously recorded Daiichi Sankyo's decision to initiate GLP Tox studies for that program in October 2016 which continues its path to the clinic. While we recognize the challenges in the PCSK9 market generally, we look forward to continue the advancement of the second therapeutic program and our continued collaboration with Daiichi Sankyo.

Further, I wish to point out that the milestone potential for the now terminated PCSK9 program has got a very small percentage of the overall milestone potential from the now more than one dozen partner programs in our plan.

Finally, I'd like to discuss our most advanced program, PRS-080, which is a highly potent inhibitor of hepcidin, a key negative regulator of iron metabolism.

Hepcidin is upregulated in states of chronic inflammation such as chronic kidney disease, effectively trapping iron in the body's iron storage cells and this in turn causes what is called functional iron-deficient anemia. PRS-080 represents a potential first-in-class therapeutic for this disease.

As you know, in 2015 we completed and record on a Phase 1 single ascending dose study conducted in healthy volunteers which very demonstrated that a single dose of PRS-080 was well tolerated and resulted in a dose dependent increase in serum iron and transferrin saturation, TSAT.

Pieris has completed a Phase 1b single and standing ascending dose study in anemic chronic kidney disease patients on hemodialysis and we'll present this data in June at the European Renal Association and the European Dialysis and Transfer Association of Congress in Madrid, Spain.

Pieris will next initiate a multi-dose Phase 2a study in the same population this month with a currently anticipated completion of enrolment and dosing of all patients in the second half of this year.

As mentioned, in February this year we announced that we have granted ASKA Pharmaceutical an exclusive option to license the development in commercial rights of PRS-080 in Japan and certain other Asian markets.

Under the terms of this option agreement, Pieris received an option payment of $2.75 million and should ASKA exercise its options to develop and commercialize PRS-080 following positive results from the planned Phase 2a study, Pieris will be eligible for more than $80 million in combined option exercised fee and milestones coming from the successful commercialization in the first indication in Japan.

Pieris may receive further development milestones for additional indications, as well as in other countries within the ASKA territory and may receive double-digit royalties on net sales of PRS-080 upto the mid to high teens.

We believe that functional iron deficiency anemia in hemodialysis patients represents a substantial medical need in Japan and amounts to a sizeable target population of roughly 80,000 patients in Japan.

This partnership with ASKA and option payment has enabled Pieris to invest in drug manufacturing facilities and future drug supply for PRS-080 which we believe will allow ASKA to more seamlessly advance PRS-080 into the next phase of development and will facilitate future partnerships for PRS-080 in the U.S. and the E.U.

Finally, I'm pleased to report that during the last quarter we also continued to advance our other partnerships. And in particular, the immuno-oncology with Roche, as mentioned continues to advance and the other current programs beyond the DS, Daiichi Sankyo program are advancing on plan.

This concludes my prepared remarks and I would now like to hand back over to Lance to guide you through our financial results for the first quarter of 2017..

Lance Thibault

Thank you, Steve. As compares to the financial results for the first quarter of 2017, when we start with revenue of which under GAAP we recognized $1.3 million for the quarter ended March 31, 2017.

This compares to $1.2 million of revenue for the first quarter of 2016, approximately $1 million of that revenue in the first quarter of this year was attributable to research funding and our collaboration with Roche, and the remainder representing the beginnings of our collaboration with Servier.

In terms of research and development expenses, they amounted to $5.4 million in the quarter ended March 31, 2017 which compares to $3.7 million in the first quarter of 2016.

The $1.7 million increase was primarily attributable to a $0.9 million increase in preclinical development, CMC and clinical costs for PRS-343 as we carry out IND enabling studies. And $0.5 million net increase in CMC and other costs associated with PRS-060 as we continued our IND enabling studies.

In G&A, expenses for the quarter ended March 31, 2017 were $4 million compared to $2 million for the quarter -- first quarter of 2016.

The $2 million increase in G&A expenses was primarily due to $0.8 million and higher personnel related costs including stock compensation, another $0.9 million increase for professional fees, principally on account of success-based fees on announced deals. And a $0.3 million increase in travel recruiting and other administrative costs.

Altogether, net loss for the quarter ended March 31, 2017 was $8 million or $0.19 per share which compares to a net loss of $4.2 million or $0.10 per share for the first quarter in 2016.

Turning to the balance sheet, total cash and cash equivalents as of March 31, 2017 totaled $55.2 million and was a $25.8 million net increase in the quarter from $29.4 million we had in the bank as of year-end December 31, 2016.

The increase in cash was driven primarily by the €30 million upfront payment received from Servier and the option payment received from ASKA, offset principally by approximately $8.8 million in operating -- cash operating expenses during the quarter. And with that quick financial report, I'll turn the call back to Steve for any closing remarks..

Stephen Yoder Chief Executive Officer, President & Director

Alright, thanks again Lance. As you all can see, we begin this year with three successive strategic partnerships; two of which are global and transformative for Pieris within a two key focus areas of immuno-oncology and respiratory diseases.

We also advance our proprietary programs and remain on-track to take our wholly-owned [indiscernible] PRS-343 in the first trials during the current quarter while advancing as sponsor on partnered lead respiratory asset PRS-060 into first human trials later in 2017 which will be funded by AstraZeneca.

Altogether, our partnerships have generated approximately $80 million in cash flow year-to-date and can bring us more than $4.5 billion in milestone payments potential in addition to royalties off future product sales, not to mention several opportunities for direct commercial sales in U.S.

So with a strong balance sheet we have the ability to make robust investments into our proprietary and co-developed programs while providing sufficient cash runway to reach several key value inflexion points; and we reiterate our belief that 2017 has the potential to be the most value creating year in the history of our company.

Thank you for joining us today and for your continued interest and support. We would now like to open the call to any questions..

Operator

Thank you. [Operator Instructions] Our first question is coming from Mike King of JMP Securities. Please go ahead..

Michael King

Good morning guys, thanks for taking the question and congrats on the progress, apologies in advance for any background noise or poor connection. Steve, I just wanted to see if you could help us think through the target patient population for 343; you know, a lot of optionality for patients where HER-2 positive breast cancer.

As we think about the role that 343 may play, where do you think the appropriate patient population lies along the treatment spectrum?.

Stephen Yoder Chief Executive Officer, President & Director

Sure Mike, thanks for the question. Well, I think the benefits -- one of the benefits having a targeted 4-1BB therapy like PRS-343 is that already the universe has focused on HER-2 positive tumors.

Now we have reason to believe from the AACR poster data presentation that we presented in April that our drug is rightly to be able to drive 4-1BB cross-linking at HER-2 levels lower than what's classically regarded as HER test positive. We are going to start playing to win by focusing on what are classically regarded as HER-2 positive tumors.

We will run our ascending escalation phase and then our expansion phases in what would be the most prevalent HER-2 positive tumors including metastatic breast, muscle invasive bladder, gastro -- gastric cancer gastro [indiscernible] cancer; these are going to be the focal areas, we will also look at other HER-2 positive tumors.

From looking at the literature we believe that not only are there a significant subset of patients who ultimately stop or fail to respond to the HER-2 therapies like Herceptin, like kansala [ph], but those patients also have immune component and we know what's happening in bladder where PD-1 antibodies are effective in a subpopulation showing that bladder cancer for example, is an immunological cancer.

So it's ultimately going to be data driven and it ultimately will not be limited to those three types of cancers but that's a good place to start and the strategic benefits now of having the strategic partnerships in place with the robust inflows of non-diluted capital will allow us to more robustly follow this data but we believe those opportunities alone provide significant value for this program.

But stay tuned as the data evolves and we'll follow them more robustly than we otherwise could have..

Michael King

Okay.

Well, let me maybe press you a little bit more; you know, where in your perception is the unmet need at the moment and given the current treatment options in HER-2 positive metastatic breast cancer?.

Stephen Yoder Chief Executive Officer, President & Director

Well, with HER-2 positive metastatic breast cancer, I mean the significant amount of patients after several years of remission come back and they really don't have a viable option; there really is no standard of care and we believe that in those patients our drug on top of emerging standard of care including PD-1 antibodies, we will be able to probe whether or not the synergistic combination of HER-2 engagement, HER-2 receptor blockade plus bringing in the T-cell specific HER-2 antigen to tumor bed will bring about a very differentiated mode of action, I mean that's why we are probing this area and that's where we do clinical trials to see if these data are lucky to read out positively but we believe that there is a compelling rationale to move into patients because of their levels of HER-2, the fact that there is no standard of care today and the fact that we believe that our drug will be able to augmented and proliferate T-cells in way that the current checkpoint inhibitors cannot..

Michael King

Thanks for taking the question..

Stephen Yoder Chief Executive Officer, President & Director

Sure, thanks Mike..

Operator

Thank you. Our next question is coming from Hartaj Singh of Oppenheimer & Company. Please go ahead..

Hartaj Singh

Thanks for the question.

I've just got a couple of questions; one is, Steve can you just remind us again on the PRS-080 Phase 1b design; what do you expect -- what learning's do you expect from the data which you're going to present and then how does that influence over the Phase 2 that you're going to be initiating shortly? And I've just got a quick housekeeping question after that.

Thank you..

Stephen Yoder Chief Executive Officer, President & Director

Sure. So this is again -- this was a single ascending dose in dialysis dependent anemic patients, it presented largely with a functional immuno -- functional iron decision phenotypes that they would have -- typically have elevated levels of hepcidin and higher levels of ceritin [ph] and moderate to lower levels of [indiscernible].

And as we showed in the healthy subjects study that our drug with in a dose and time course dependent manner elevate or mobilize iron and also increased TSAT. We hope to be able to demonstrate that same level of robust iron mobilization in TSAT increase in the patients who start with much higher levels of hepcidin than the healthy subjects.

So the design itself involves -- it was three doses of six patients per cohort received drug to placebo, so it's a total of 24 patients. And what we're doing now with the unblinding of the data coming imminent is to look at our drugs ability to mobilize the iron.

What the hepcidin feedback might be to help them inform the right dose to pursue in the multi-dose study which as a reminder will involve five administrations of drugs over a four-week period given once weekly to assess the ability of our drug to drive hemoglobin levels beyond simple iron mobilization..

Hartaj Singh

Great, fantastic. I really appreciate that color and that insight. And then just -- I noticed that in the press release you had indicated you've gotten sort of $80 million in cash flow in 2017 for your -- those are -- I assume those are the upfronts, right.

And then just -- I don't know, I might have missed this on the commentary from Lance but just any thoughts on how you're going to recognize the AstraZeneca upfront?.

Lance Thibault

First question, yes, those are the upfronts generated in the business development deals of which AstraZeneca under the terms expect will be in here in the second quarter. Revenue recognition, that's the tougher one -- we're just getting our arms around it.

I think similar to our collaboration with Servier that the upfront money in connection or in the collaboration with AstraZeneca will be recognized under GAAP over the period of our obligation which is an extended period of time under a number -- under the various deliverables identified for accounting purposes in the contract.

So that's kind of a non-answer but you know, think back again at the end of the second quarter we'll have a good grip on that but it will be over a period of time like [indiscernible]..

Hartaj Singh

Sounds good, Lance. Thanks again for the color. Just one last question, you know, if your operating expenditures sort of stayed flat to slightly up fourth quarter -- the first quarter.

Is that sort of a good way to think about it -- you know, OpEx going flat to up through the end of the year or just any thoughts there would just in terms would help us with modeling. Thank you..

Lance Thibault

I think flat is up with the emphasis on us as we -- you know, to an extent anyway as we get going with Servier and AstraZeneca..

Hartaj Singh

Got it. Again, I appreciate all the answers. Thank you..

Operator

[Operator Instructions] Our next question is coming from Boris Peaker of Cowen & Company. Please go ahead..

Boris Peaker

Great. I'd also want to add my congratulations on the recent progress on your line of partnerships.

And my first question is on 343, I'm just curious, is that an assets that at some point you'd also like to partner out maybe -- and if so, at what stage of development do you think that would make sense or are you really committed to fully retaining this for a significant period of time?.

Stephen Yoder Chief Executive Officer, President & Director

Thanks for the question Boris and I think part of our corporate strategy involves taking PRS-343 as far along as we can without partnering it.

And again, what the partnerships announced in the last couple of months allow us to do is to more robustly follow that data as we mentioned and ultimately gives us -- I think the stay in power to take this to proof-of-concept on our own more globally; and then ultimately take it to market in the United States as part of our corporate strategy of marketing and selling transforming affair to the -- in the U.S.

Unlike the Astra program that was partnered PRS-060 which had more complex formulation; things we have to deal with as well as walking into commercial device early in the game to accelerate to time the market.

This program, PRS-343, is at least a lot less complex from a delivery perspective and we believe following the data out there already, following the discussions with our very esteemed advisory network, we have a line of cycle proof-of-concept, we have the capital to get us there and we will then be data driven and prioritize indications or at least send indication to take through the market in the US on our own.

So precisely the time to think or partnering that that thoughtfully outside of the United States that some people are going to work through; some that were not -- we're currently not prioritizing..

Boris Peaker

Great.

And my other question is on the Roche partnership; I'm just trying to -- curious to know when will the target be disclosed -- at least some initial targets?.

Stephen Yoder Chief Executive Officer, President & Director

I mean at the end of the day its upto Roche, as it's their target and they came to us in the end of 2015 with a specific idea.

I want to emphasize it is just a single target but the mandate is to discover and characterize a panel of unique anti-calin's on different epitopes on that target with the ability to think about a multi [indiscernible] approach to more robustly engage that target or functionally engage that target, as well as to be able to join generically one or more of those anti-calins with potentially other antibodies or biologics in the Roche pipeline.

So it's just a target but it does show our ability to address several episodes we form target for a unique multi-pattern mode of action. And I would not expect -- honestly, I would not expect the disclosure of the target in 2017, maybe after an anticipated project handover towards the end of this year there could be a change in the results..

Boris Peaker

Great. Thank you very much for taking the questions. And again, congratulations on the progress..

Operator

Thank you. Our next question is coming from Mike King of JMP Securities. Please go ahead..

Michael King

Thanks for taking the follow-up Steve. I just wonder on 9001A; I'm not sure I heard you -- I'm on a train and got a bad connection but I know you said you're not going to develop that yourselves.

Just as far as seeking a partnership is concerned, can you talk about sort of what properties or attributes the molecule may have that could make it competitive in the current treatment landscape that might -- and tie someone into picking that up your hands?.

Stephen Yoder Chief Executive Officer, President & Director

Sure, thanks for the follow-up. I think this is a new update for the company. I would say three things to consider when we're talking about the DS-9001A.

The first is that we just received notice of this on Monday and we need to go through the data thoroughly, we started to look through it but we want to have a more thorough review before we formulate any opinions.

And again, I would also want to caution anyone against conflating what is I think a well behaved anti-calin that appears to be well tolerated, appears to have robustly engaged to its target, and mechanistically at a healthy patient population; I think behaved as one would have expected; analogous to how our PRS-080 molecule mobilized iron potently in healthy subjects in the healthy volunteers.

So this is certainly not a re-through of anything through the anti-calin drug claps [ph] which I know you're not implying in your question, I just want to make sure that's ultimately -- abundantly clear to our investors. I think the contract provides a great deal of flexibility in how we can go about partnering that program.

Potentially the reduction of the milestone burden otherwise that would have been bore by the agency [ph] could make this otherwise more attractive to someone. The mode of action for -- the intended mode of action that Daiichi were pursuing with the [indiscernible] technology into this was a long acting half-life.

We know other programs in this space, other companies in this space or likewise trying to prioritize that type of mode of action; so we have to assess how competitive this program would be as those program move into the space after the initiation of this program a Daiichi several years ago.

But the lower cost of goods, as you reminded, this is made in bacterial cells; so a lower cost of goods could potentially be an advantage but I would like to reserve further comment at this time as we had a more thorough review of the data.

I would just end by saying, I think we've demonstrated our ability to partner and partner well; this includes last five months alone. So this program has an opportunity to partnership, I think we'll be able to fund it..

Michael King

Thanks for taking the follow-up..

Operator

Thank you. I'm showing no further questions in queue at this time..

Stephen Yoder Chief Executive Officer, President & Director

Okay. Well, again thanks everyone for your attention today and for your continued support of our company. We look forward to keeping you updated on the continued progress which will include presentations of a variety of upcoming R&D conferences. Thank you for joining the call and have a great day..

Operator

Ladies and gentlemen, thank you for your participation. Today's conference has concluded. You may disconnect your lines at this time and have a wonderful day..

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