Joe Schepers - Executive Director, Investor Relations and Corporate Communications Michelle Berrey - President and Chief Executive Officer Herve Mommeja-Marin – Vice President, Clinical Research Linda Richardson - Chief Commercial Officer Tim Trost – Senior Vice President and Chief Financial Officer, Corporate Secretary.

Daniel Brims – Cantor Katherine Xu – William Blair Marc Frahm – Cowen and Company.

Good morning and welcome to the Chimerix Second Quarter 2015 Financial Results Conference Call. Today’s call is being recorded. All lines have been placed on mute. [Operator Instructions] At this time I would like to turn the call over to the Company’s Executive Director of Investor Relations and Corporate Communication, Joe Schepers.

Please go ahead, sir..

Thank you and welcome to Chimerix second quarter 2015 financial results conference call. On the call today are Michelle Berrey, President and CEO; Tim Trost, Chief Financial Officer; Linda Richardson, Chief Commercial Officer; and Herve Mommeja-Marin, Vice President, Clinical Research.

Before we begin allow me to read Chimerix Safe Harbor regarding forward-looking statements.

During the course of this conference call, the Company will be making certain forward-looking statements such as statements relating to certain R&D programs, including our Phase III SUPPRESS and AdVise trials for future clinical trials of brincidofovir, also known as brinci and related matters.

These statements involve risks and uncertainties that may cause actual results to differ materially from those projected in the forward-looking statements.

These risks and uncertainties are discussed more fully in Chimerix filings with the Securities and Exchange Commission, including without limitation its most recent quarterly report on Form 10-Q filed earlier today, its most recently filed reports on Form 8-K and other documents subsequently filed with or furnished to the Securities and Exchange Commission.

All forward-looking statements made on this call speak only as of the time they are made and Chimerix undertakes no obligation to update these statements to reflect subsequent events or circumstances. We issued a press release this morning containing financial results for the second quarter 2015.

The press release is available on the Company’s website at www.chimerix.com. Dr. Berrey will begin with an overview of this year’s progress and key milestones, Dr.

Herve Mommeja-Marin will review our brinci, clinical and smallpox development programs, Linda Richardson will provide an update on our commercial activities and Tim Trost will review our second quarter financial results. Dr. Berrey will conclude the call by reviewing our key initiatives and expected milestones for the next six months.

At this time I would like to turn the call over to Michelle Berrey..

Thank you, Joe. Good morning and welcome to our update call. The first half of 2015 has brought tremendous progress and productivity for Chimerix. In January of this year, we announced the issuance of a composition of matter for brincidofovir that extends exclusivity to 2034.

This will provide us with nearly two decades of patent coverage, a great opportunity to take advantage of the broad spectrum activity of brinci and to explore additional indications and diseases in populations for which there are no current therapies.

At the BMT Tandem Meeting in February, we reported preliminary results from the initial 85 subjects enrolled in our open label Phase III AdVise study. Patients who received brinci for adenovirus infection had a mortality rate of less than 40%. These initial data were of course very encouraging given the reported mortality rates of up to 80%.

Herve will provide some additional updates on the AdVise trial in a few minutes. In March, we shared the first output from our Chimerix 2020 initiative and the initial steps we’ve taken to dedicate a proportion of our chemists to exploring other molecules, which may benefit from our lipid conjugate technology.

In April BARDA announced their intent to award a procurement contract to the Company to include brinci in the CDC’s Strategic National Stockpile as a medical countermeasure in the event of a smallpox bioterror event. BARDA stated that it anticipates announcing this award of the contract by the end of September 2015.

On our last financial results call in May, we shared the trial designs for our upcoming trials SUSTAIN and SURPASS. These trials were designed to demonstrate brinci’s potential to prevent CMV infection in two key patient populations undergoing kidney transplantation.

In the SUSTAIN trial CMV seronegative patients who receive a kidney from a CMV positive donor and in SURPASS to more frequently encountered population of patients who are CMV seropositive before their transplant.

Both trials have a primary focus on CMV prevention but significantly both provide us with the opportunity to better understand the key role that BK virus infection plays and the decline of renal function and kidney graft loss and the potential of brinci to prevent BK associated nephropathy.

In June, we completed a successful offering of common stock with net proceeds of approximately $162 million which provided us with funds for SUSTAIN and SURPASS, for expansion of manufacturing, for pre-launch commercial activities and for additional research and development programs.

In July we announced that we met the primary endpoint of improved survival in our pivotal study of smallpox infections, the major step toward a potential FDA approval of brinci as the first treatment for smallpox infection.

And already in August, we announced the completion of enrollment of AdVise which puts us on track to report topline data from both SUPPRESS and AdVise in early 2016. At this point, I would like to turn the call over to Herve Mommeja-Marin, our VP of Clinical Development to provide an update on our progress with brinci..

Thanks, Michelle. First, in June, we completed enrollment of the targeted 450 patients in SUPPRESS, our Phase III trial evaluating brincidofovir for the prevention of CMV infection in a high-risk stem cell transplant reception.

The primary endpoint of SUPPRESS is prevention of clinically significant CMV infection through the first 24 weeks post transplant. Patients receive brincidofovir or placebo orally twice weekly for the first 14 weeks after their transplant, and then are followed for 10 weeks after treatment.

Although there are a handful of antivirals that can be used once a patient reactivates CMV, the toxicity of these agents does not permit their use as prevention. So current strategy used for all other infectious risk these patients face.

Even with the availability of sensitive PCR to detect CMV reactivation as soon as it occurs we know that patients who do reactivate CMV has twice a risk of dying in the first year after transplant as patient who do not reactivate CMV.

Important secondary endpoint in SUPPRESS include the incidence of clinically significant infections with other DNA viruses that often coexist in immunocompromised patients such as adenovirus, Epstein-Barr virus and BK virus.

Preventing these other viral infection could have a significant impact on the re-hospitalization and other all healthcare utilization. But more importantly, the cumulative impact of preventing CMV and other DNA viral infection could lead to a decrease in transplant related mortality.

This critical secondary endpoint in SUPPRESS will also be reported in early 2016. Earlier this week we announced completed enrollment of our second Phase III trial AdVise for the treatment of adenovirus infection.

The AdVise study is designed to evaluate brincidofovir for the treatment of life-threatening adenovirus infections in pediatric and adult patients.

The AdVise trial enrolled over 200 patients with serious adenovirus infections, including over 100 patients in the key population of bone marrow transplant recipient with disseminated adenovirus disease, a life-threatening infection that has reported mortality of up to 80%.

Bone marrow recipients with localized or asymptomatic adenovirus infection were also enrolled in AdVise as well as patients with other reason for immune suppression that had confirmed serious adenovirus infection, a group that included solid organ transplant recipients and patients receiving chemotherapy.

All patients enrolled in AdVise receive brincidofovir orally twice-weekly for 12 weeks, and are followed for a minimum of 12 weeks after treatment with a primary endpoint of overall survival. We are conducting a clinical outcome study at the AdVise medical centers to provide matched historical controls for the survival data from AdVise.

The rapid enrollment of this pivotal trial within less than 18 months underscores the significant need for an antiviral that can be used to treat these vulnerable patients with adenovirus infection. We expect to report data on AdVise in early 2016.

In July, we met with the European Medicines Agency, EMA, or the European equivalent of the FDA, to review the acceptability of the historical control design in support of a marketing application in the EU.

The meeting was part of a pilot program for allowing Chimerix to receive parallel advice and guidance from the EMA as well as some key health technology assessment, HTA for short, bodies such as NICE which are in charge of reviewing reimbursement dossiers in the EU.

In their final guidance the EMA agreed with our rationale for proposing an historical control study design and with other key features of the study design. The EMA also provided guidance on additional European data that would facilitate their review of a marketing application. Linda will comment on the HTA feedback later on this call.

Third, we recently announced that brincidofovir demonstrated a statistically significant survival benefit in a pivotal study in animal model for smallpox.

The primary objective of this study was to assess the impact on mortality of immediate or delayed treatment with brincidofovir compared with placebo in animals that had clinical evidence of disease.

The study was conducted in a validated rabbitpox model under the FDA’s Animal Efficacy Rule which allows for testing in animal models in diseases which are not ethical or feasible to study in humans. Animals were given a lethal inoculum of the rabbitpox virus and were monitored for clinical signs of disease.

Animals treated with brincidofovir upon the first clinical sign of disease and animals that received brincidofovir 24 or 48 hours after the first clinical signs of disease demonstrated this statistically significant reduction in mortality compared to animal that received placebo.

Final results of this study are expected in the fourth quarter of 2015 and will be submitted to an upcoming medical conference.

We look forward to the opportunity to present this important data and to our discussions with FDA about additional studies that may be needed to support a regulatory decision regarding the use of brinci for the treatment of smallpox.

As you can see, we have made significant progress and are focused on delivering results on SUPPRESS and AdVise in early 2016. If positive this data forms the foundation of our initial applications to the FDA and other healthcare authorities.

If approved brincidofovir would be the first and only product for the prevention of cytomegalovirus in bone marrow transplant recipients, for the treatment of adenovirus infection and for the treatment of smallpox.

Due to the high unmet medical need and the lack of a proven antiviral agent, the FDA has granted Fast Track Designation for all three of these indications, CMV, adenovirus, and smallpox. Now, I would like to turn the call over to Linda Richardson for an update on our preparations for a potential commercial launch..

Thanks, Herve. This morning, I’ll be providing an update on several of our commercial readiness activities and preparation for the potential launch of brincidofovir, and it is truly an exciting time on the commercial side. First, we’ve undertaken an extensive global market assessment study encompassed in the U.S. and 17 other key countries.

This initiative involves detailed country-level assessments of current CMV and adenovirus management strategies in patients undergoing stem cell and solid organ transplants.

This study also includes identification of unmet needs in combating DNA viruses, market access and reimbursement landscape mapping and information regarding how the transplant community stakeholders may position the use of a broad spectrum antiviral like brinci.

It’s been my experience during past launches that this type of information is critical to building an understanding of projected product uptake, market prioritizations and eventual launch sequence in ex-U.S. Second, as we’ve previously shared, we intend to commercialize brinci in the U.S. ourselves.

We have identified our key transplant centers and recognized that the HCT market is highly driven by transplanting protocols and pair access. We’ve also recently completed the benchmarking exercise to evaluate commercial structures and approaches taken by other companies in similar positions.

Currently, we are mapping out our launch structure and look forward to sharing more details with you in the future.

Third, we continue to gain insights into the needs of the extended transplant community worldwide through market research, with face-to-face Customer Advisory Boards as well with audiences ranging from pharmacy and distribution networks to discharged nurses and transplant coordinators as well as the more traditional key opinion leader engagements.

These findings are forming our unbranded educational platform which we plan to introduce in advance of launch. When you have the potential to introduce a paradigm-changing therapy that is first to market, it is important to ensure that the educational needs are identified prior to product introduction.

Our educational outreach also involves setting the stage for helping pairs and transplant centers understand the real-world clinical and economic consequences of stem cell and solid organ transplants.

As I shared on a previous earnings call, we’ve undertaken works that involved assessing hospital and insured databases to evaluate these consequences and are generating publications on our findings. In fact, we already have submitted abstracts to key meetings and I’m pleased to share that several of these have been accepted.

So we look forward to sharing those presentations with you in coming months. Staying on the topic of market access, I’ll touch on the EMA HTA meeting we had last month.

This interaction provided us with feedback that will help the market access team proactively prepare robust materials for the reimbursement assessments required by various EU countries.

Having a sense of the most relevant economic models and information needs from HTA representatives at this stage of our development is highly valuable and should help us accelerate reimbursement discussions at the appropriate time upon potential approval of brincidofovir in the EU.

Lastly, I’d like to mention that the launch of brincidofovir requires extensive strategic planning and strong execution. It’s important to have the right people in place at the right time.

To that end, we are continuing to build out our commercial structure with new hires in select areas including business operations, marketing – market access and channel management. Now I’d like to turn it over to Tim Trost..

Thanks, Linda and good morning, everyone. As Joe mentioned in his introductory remarks earlier today we issued a press release containing our financial results for the second quarter 2015.

Starting with our balance sheet, at the end of the quarter we had approximately $404 million in capital available to fund operations, $1.5 million in debt and approximately 45.8 million outstanding shares of common stock.

As Michelle mentioned, the significant increase in capital available is due to the Company’s successful common stock offering in June 2015. Turning to our statement of operations, Chimerix reported a net loss of $24.8 million or $0.59 per basic and diluted share for the second quarter of 2015.

During the same period in 2014, the Company recorded a net loss of $11.7 million or $0.39 per basic and diluted share.

Revenues for the second quarter of 2015 increased to $4.1 million compared to $0.9 million for the same period in 2014 due to an increase in the second quarter of 2015 in reimbursable expenses associated with the Company’s ongoing contract with BARDA and the recognition of deferred revenue related to the Company’s collaboration and licensing agreement with ContraVir Pharmaceuticals.

Research and development expenses increased to $21.8 million for the second quarter of 2015 compared to $8.1 million for the same period in 2014.

This increase was primarily due to the effect of costs related to the ongoing Phase III SUPPRESS and AdVise trials, the start-up costs for SUSTAIN and SURPASS and growth of the Company’s clinical, regulatory and development groups.

We continue to expect a significant increase in R&D expenses for the full year 2015 compared to full year 2014 due to the costs related to both of our ongoing Phase III trials, the two planned kidney transplant trials, continued development on our commercial process development, and preparing for the anticipated NDA in 2016.

We’ve now incurred $39.2 million in R&D expenses for the first half of 2015 versus $45.4 million for the full year 2014. R&D expenses may be uneven from quarter-to-quarter. General and administrative expenses increased to $7.3 million for the second quarter of 2015 compared to $4.4 million for the same period in 2014.

The increase was primarily due to the preparation for the expected commercialization of brincidofovir and the growth in the Company’s infrastructure. For the full year 2015, we expect an increase in G&A expenses compared to the full year 2014 based on these same factors.

Loss from operations was $25 million for the second quarter of 2015 compared to a loss from operations of $11.6 million for the same period in 2014. The variance was due primarily to the increased research and development and general and administrative expenses, as previously discussed. Let’s turn now to BARDA.

As we stated in our previous conference call, BARDA has announced their intent to award a sole source contract to Chimerix for the procurement of brincidofovir for the treatment of smallpox.

Specifically, on April 13, 2015 the Department of Health and Human Services, Office of the Assistant Secretary for Preparedness and Response, Biomedical Advanced Research and Development Authority, or BARDA, posted a notice of intent to use other than full and open competition to award a sole source contract to us for procurement of brincidofovir for the treatment of smallpox.

We have received from BARDA a request for proposal, or RFP, entitled 2015 procurement of a second smallpox antiviral drug for the Strategic National Stockpile. Notwithstanding the issuance of the RFP, there can be no assurances that we will enter into a sole source contract with BARDA.

Before we can enter into the contract, we must negotiate its terms, including the price and delivery schedule. Additionally as a government agency BARDA’s ability to enter into a contract is subject to continued funding for this purpose, which can change at any time. We intend to submit a proposal to BARDA in August 2015.

Now, I will turn the call back to Michelle for closing remarks..

Thank you, Tim. Looking ahead to the remaining months of 2015, we expect to be in discussions with BARDA regarding our ongoing development of brincidofovir for smallpox and regarding the potential procurement of brinci for the National Stockpile.

We expect to begin our two trials in patients undergoing a kidney transplant, SUSTAIN and SURPASS, in the second half of this year. Importantly, we anticipate equal participation by European and U.S. medical centers in these trials based on the feedbacks from our physician and advisory meetings to-date.

As Linda mentioned we consider our educational initiatives over the next 18 months to be critical for a successful commercial launch.

We’re working with leading academic centers and reviewing data from healthcare claims databases to define the epidemiology of the big five DNA viruses, adenovirus, BK, CMV, EBV and HHV-6 and the frequency of multiple viral infections in transplant recipients and other immunocompromised patients.

It is increasingly clear from our AdVise trial and some of the early data from serum bank studies and other sources that what we’ve once believed was rare, a patient with two or more active viral infections is in fact a common scenario.

We will be presenting epidemiology and other data at key medical conferences during the coming months showing the correlation of multi-viral infections which risks are prolonged and re-hospitalizations and first year post-transplant mortality.

We will also be presenting important data at the American Academy of Clinical Pharmacy, ACCP, supporting the lack of key drug interactions for brinci, a factor that can be so critical for transplant recipients who may be taking dozens of other medications.

Longer term our Chimerix 2020 initiative is focusing on potential portfolio expansion which could include other medications in the stem cell and solid organ transplant space.

And our discovery teams are bringing forward new leads from our own compound library and identifying compounds that we believe may benefit from the lipid conjugate technology for oral delivery or decreased risk of toxicity.

I’d like to take a moment to express our gratitude to the physicians and members of the transplant teams at the medical centers that have participated in the SUPPRESS and AdVise trials and especially for the patients and their families who participated in the brinci clinical trial.

As we look forward to data availability in early 2016, we remain focused on the end goal of getting brinci approved for the prevention and treatment of life-threatening viral infections.

I continue to be humble by the dedication of the medical teams in these transplant centers and by our own Chimerix’s employees who share the vision of delivering improved quality of life for patients impacted by viral infections. Thank you for joining us this morning.

We look forward to sharing updates during the next six months leading up to data read-outs for SUPPRESS and AdVise in early 2016. I’ll now turn the call over to the operator for any questions..

[Operator Instructions] And our first question comes from Geoff Meacham from Barclays. Your question please, sir..

This is actually Mike in for Geoff. Thanks for taking the question and congrats on all the progress. .

Thanks, good morning..

Maybe just with respect to your European filing strategy, it looks like you’ve guys have gotten some feedback and you sort of mentioned potential for having to do some additional studies or provide additional data. Could you maybe give us a sense of what that could look like? Thanks..

Yes, thanks for the question, Mike. So we are not giving a lot of detail at this point, I think. We were encouraged with our interactions to say that there are no additional major studies that would be required at the time of filing.

Certainly the data themselves will be a key review issue and we do intend to have data from Europe from patients through either Emergency IND equivalent to access [indiscernible] data we have available to show that the treatment standards are the same in Europe as they are in the U.S.

But I think overall, we were very pleased with the interactions that we’ve had to date and at least at this point, the lack of any major additional studies that would be required at the time of filings..

Got it. Great. Thanks..

Thank you very much..

Thank you. Our next question comes from Jessica Fye from JP Morgan. Your question please..

Hi this is [indiscernible] in the call for Jessica. Thanks for taking the question. You mentioned with the recent AdVise enrollment announcement that adenovirus infection may be more frequent than previously thought.

Can you elaborate on what you’re seeing that makes you think that and how your view has evolved with respect to the commercial opportunities there?.

Sure. It’s a great question. So for adenovirus one thing I’d like to emphasize is that we have been working diligently to define the epidemiology for this infection.

Really we’ve heard anecdotally or single center studies about adenovirus over the last decade or so which really been in the last couple of years with the potential of brinci to be used as a treatment that many of these centers have begun actively screening for adenovirus which has increased our understanding of which patients are at very high risk or progression of an early adenovirus infection to a full-blown disseminated infection with that risk of life-threatening infection, multi-organ infection.

Particularly children have a much higher risk. And at some of our centers where there may be an increase in T cell depletion, for example, and a higher risk transplant such as haploidentical transplant, the risk is higher and we’ve seen some data with up to 50% of children being infected with adenovirus during that post-transplant period.

That’s why the incidence rates estimate from around 5% to over 50% depending on the center. Again, we’re also, not surprisingly, seeing an increase in appreciation as these centers are screening for adenovirus.

The other key factor that’s driving this is within our AdVise study Cohort C which allowed for enrollment of patients you had serious adenovirus infection in which we did not require that they document what their immunodeficiency was.

So Cohort C could include stem cell transplant recipient who had received an autologous transplant or solid organ transplant recipients as well as patients who had undefined or unknown immune deficiencies.

So that’s really where I think the greatest unknown potential is as what we need to explore more about the frequency and the risks for serious adenovirus infection in many of these other patient populations.

One example of that was our recognition of an increased risk in pediatric patients who have undergone a liver transplantation and present with adenovirus hepatitis. We are going to be presenting later this fall some of those data in pediatric liver transplant recipients who were treated through the AdVise trial.

So all of that really comes back to, as we talked about with Linda, the educational initiative about making sure, not just for adenovirus, but for all of the double stranded DNA viral infections that we have a good understanding of the epidemiology so that we know where to focus our efforts in the post-marketing setting.

We have begun building out our medical affairs group and defining additional studies that we would like to pursue to better understand what the risks and potential benefits are for brinci in that broader population..

Thank you..

Thank you..

Thank you. Our question comes from Daniel Brims from Cantor. Your question please..

Hi, thanks for taking my question. Just want to ask another question about the EMA.

What's - are you looking at the same timeline for submitting your MAA as the FDA or with the additional data you might require is that going to be pushed back a little bit from your NDA discussion?.

Hi, Dan. It’s a good question. The data that we believe will be necessary for filing is the same data package that we will have for the NDA. So with that, we do believe that they can fall much closer together than, for example, if we’ve been required to conduct another large study specific for European patients.

Having said that, there are other data that we will be gathering between now and the time of our MAA namely the healthcare practices specific for the CMV and adenovirus. We do have good data on the stem cell transplant protocols which as in solid organ transplant are very similar between the U.S. and Europe.

Just some additional data that we’ve had planned all along to gather regarding clinical duce practices. Again with adenovirus because there are no other therapies, it’s pretty straightforward we see sporadic usage of IV cidofovir off-label, some use of IVIG which tends to be more center dependent et cetera.

So it’s really just characterizing those data for the European health authorities..

All right. Thank you. And just a question on the BARDA contract. It’s $100 million with a possibility of $435 million if they buy the full amount of material from you.

When would they make that decision on whether or not if they’re going to basically max that out and especially now that you have the data on smallpox in rabbits?.

So two points now on that. One is that a potential BARDA procurement contract is independent of our development work. So BARDA was authorized to potentially acquire compounds that are investigational or do not have an indication for the specific disease for which it is being stockpiled.

So they’re really two separate tracks, the development and certainly our goal of having an indication for brinci for the treatment of smallpox, but secondly the procurement negotiations are completely separate.

So to that point of the procurement, what the statement – the posting in April of this year address this, both of those two figures that you named, the $100 million, $435 million. Our understanding from that statement is that they would like to announce a contract by the end of September 2015.

As with all federal agencies their contracts are set by the amount of money that they are given by our Congress and the budget makers. So that’s going to drive part of that. Typically for these contracts there is a base segment and then there can be additional options going forward.

All of that is subject to negotiation and again none of these are a guarantee. So watch the space..

All right. Thank you. .

Is that helpful?.

Thanks for taking my questions..

Thank you..

Thank you, next question comes from Katherine Xu from William Blair. Your question please..

Good morning, Katherine.

Good morning. I have quite a few questions if you don’t mind.

First up on SUPPRESS, can you just comment on your current thoughts on the OS endpoints? Secondly on AdVise, what is exactly the endpoint? Is that the endpoint for the whole population, overall survival, or can you stratify and look at Cohort B and if Cohort B is positive and you can get approval or do you have significance in the overall population? And thirdly, on the BARDA contract, so if they do exercise the whole thing that is over how many years, what kind of time frame is that? And lastly, what is your presence like at ECOG? Are you going to have the smallpox data there? Would any of the marketing studies that Linda mentioned be there or any other data or any other conferences that you guys would be present in the fall?.

Okay, I think I’ve got all those, staring from it. So, first on SUPPRESS, so your question with regard to the secondary endpoints on survival, we are looking at the overall survival and non-relapse mortalities, specifically transplant related mortality generally driven by the viral infections.

We did not power the trial for survival but it is listed as a key secondary endpoint and our intention is to have those data available at the time of the topline release in early 2016. So that would include both the primary endpoint and the key secondary endpoints that we know we and you are interested in hearing about.

For AdVise, the key Cohort is that Cohort B, the allogeneic stem cell transplant recipients who had disseminated infection. We are going to be providing to the agencies those historic matched controls for those disseminated adenovirus infection patients.

In addition, we will be providing data from the Cohort A historic matched controls, again from the same centers as participated in the AdVise trial.

For Cohort C, this has really been more of an opportunity for us to better define the epidemiology to see which other groups are at high risk for disseminated adenovirus infection and to define what those baseline characteristics are that predict for rapid progression of adenovirus and high mortality.

But because those data are scarce, we don’t think that we will be able to have adequate matched historic controls for any of the significant groups such as the liver transplant recipients that we see in that Cohort C population. So again the key focus for our NDA for adenovirus infection will be the allogeneic stem cell transplant recipients.

Of course, having said that, we will provide all of the data that we have in adenovirus to the agency for their review. On BARDA, the contract potential, again, can be – is all still under negotiation and there is a base segment with the potential for additional options which can be one to five years.

So again these will all be elements of our negotiation with BARDA on the delivery schedule, the total number of courses of therapies that will be delivered and the price for that. So that could be over the next five years, if that’s helpful. And then lastly on – if I can ask Linda to go through our abstracts that we anticipate presenting at ECOG..

So from the commercial standpoint, we will have an abstract at ECOG on hospital readmissions among patients who underwent stem cell transplantation, we will have an annual virological response to brinci in patients with evidence of resistance, and some other evidence of activity with – in CMV in vitro.

So we will be fully on there and awaiting some other information from IDSA for relevant abstracts as well..

How about that smallpox data, where would that be?.

We don’t know yet. We will certainly let you know as soon as we have confirmation of which venue that will be presented at, but it’s certainly our hope that that will be presented this fall as well..

And lastly, just on the overall survival endpoint again for SUPPRESS, can you just comment on your powering assumptions or your thoughts on the powering assumptions given the size of the study and what we know so far?.

Right. So the powering for SUPPRESS was based on CMV prevention and from the data from our Phase II trial. We powered the studies, of over 85% powered to demonstrate a 50% reduction in CMV events.

Again, the types of patients who enroll in the trial, meaning those higher risk types of transplants, those factors – many other factors will determine the rate of mortality that we might see in the trial. So we did not have any assumptions regarding the rate of mortality we would see in the trial. Again, it’s a 24-week trial.

Most of the data that we have in non-relapse mortality in stem cell transplant recipients are one-year mortality. Again, most of that – the inspection related mortality is driven by those first three to four months, that area of highest risk.

The data that came from the Fred Hutch that we’ve referenced, the risk of mortality in patient who reactivate CMV even with the very early detection of CMV reactivation by sensitive PCR and even in those patients in centers who are very rapidly treated with ganciclovir and foscarnet, other available anti-virals, even in our current – with the current standards we still see twice the risk of mortality in patients who reactivate CMV versus those who do not reactivate CMV which really points to the inadequacy of our current approach for CMV and that is what gives us the confidence that avoiding CMV reactivation has the potential to have a significant impact on mortality.

Add that to the potential cumulative effect of avoiding other double stranded DNA viral infections BK, EBV, HHV-6 and we believe that increases the probability. Having said that, we do not have point estimates or a six-month trial of brinci.

So we will be looking very closely at that mortality, overall survival and non-relapse mortality and we’ll present that as well with the primary endpoint data..

Thank you..

Thank you..

Thank you. And our last question comes from Marc Frahm, Cowen and Company..

Yes, thanks for taking my question.

On the SUPPRESS trial, I was just wondering, if there is any stratification for the co-infections with the viruses beyond CMV and adenovirus? And then what do you think you might need to show in order to get that type of label including those viruses? And then finally, given the high level of co-infection, is that really important in terms of how many more patients could you really treat that wouldn’t already be indicated based on just the CMV label?.

Great. So, really good questions. With regard to the other DNA viral infections, current standards are not to screen for seropositivity or presence of antibody as a predictor of reactivation. Frankly, because there’s never been anything that you could do about it if you did find that those patients were at increased risk.

The one exception there is for patients who are seropositive for Simplex and Veracella in which – in many institutions they are placed on higher dose, say aciclovir or valaciclovir.

The other viral infections though we are monitoring for and the bank serum for all of these patients in SUPPRESS that’s obviously on placebo and on active brinci, in real-time, if there is a suspicion of a virally mediated clinical event, for example, patient who has mental status changes, who is very early in infection and in the time frame where we would anticipate potential HHV-6 related encephalitis, the physicians can send samples in real-time and we can test for HHV-6 and the CSF, for example.

So we are looking for clinically relevant reactivations and primary infections, collecting those data during the 24 weeks of the trial and in addition, we’ll be running all of these bank specimens to look at not just the frequency, but also the order of reactivation.

One thing that has been clear from our AdVise trial is that with these more opportunistic infections like adenovirus, it’s very clear that these patients have multiple viral infections at the same time or at least at the time that they’re presenting with an active adenovirus infection.

So that’s why we believe it’s important for us to better define the epidemiology so we understand who is at increased risk. To your point about whether that could have implications for broader use or implications for the label, certainly, if we have demonstrated statistical significance on avoidance of one of these other viral infections.

For example, BK virus, that is something that could be included in the product insert although doubtful listed as another indication per se.

So those are datasets that we will be including and some of our early data read-outs, but even more so as we get through that first year post launch rolling those data out with some of these additional studies that were conducted within SUPPRESS.

So looking at the long-term impacts of HHV-6 reactivation during the first three months post transplant, we are looking at that impact of, not just acute infection but what some of the long-term implications are including long-term memory loss, for example.

The more important thing I think is really looking at what the cumulative impact of avoiding all of these different viral infections could be on that non-relapse mortality endpoint. So that’s certainly the first place that we’ll be looking in the secondary endpoint..

Okay. Thank you..

Thank you very much..

Thank you. I would like to hand the conference back over to Dr. Berrey for any closing remarks..

Thank you. I wanted to thank you all for participation in this morning’s call and we look forward to updating you all again very soon. Thank you. Thank you all.

Thank you. Ladies and gentlemen, thank you for participating in today’s conference. This concludes our program. You may now disconnect. Everyone have a wonderful day..