Michelle LaSpaluto - Senior Director of Accounting Michelle Berrey - President, Chief Executive Officer Garrett Nichols - Chief Medical Officer Linda Richardson - Chief Commercial Officer Timothy Trost - SVP, Chief Financial Officer and Corporate Secretary.

Yigal Nochomovitz – Citigroup David Lebowitz – Morgan Stanley & Co..

Good morning. Welcome to the Chimerix Conference Call discussing the Financial Results for the Third Quarter for 2016. Please be advised that today's call is being recorded at Chimerix's request. I would now like to turn the call over to Michelle LaSpaluto from the Chimerix..

Thank you and welcome to the Chimerix third quarter 2016 financial results conference call. This morning at 7:30 AM Eastern Time, we issued a press release containing financial results and other updates for the second quarter of 2016. The press release is available on the company's website at www.chimerix.com.

You may also access today's call via webcast on the Investors section of the Chimerix website. An archive of the webcast will be available approximately two hours after the conclusion of the event.

With me on today's call are Michelle Berrey, President and CEO; Garrett Nichols, Chief Medical Officer; Linda Richardson, Chief Commercial Officer; and Tim Trost, Chief Financial Officer.

Before we begin, I would like to remind you that the statements made on today's call include forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995 and are subject to risks, uncertainties and other factors, including the possibility that there may not be a viable continued development path for brincidofovir, that the FDA and other regulatory authorities may not approve brincidofovir or brincidofovir-based regimens and that the marketing approval, if granted, may have significant limitations on their use.

As a result, brincidofovir may never be successful and commercialized. In addition, Chimerix may be unable to file for regulatory approval of brincidofovir with other regulatory authorities. These risks, uncertainties and other factors could cause actual results to differ materially from those referred to in the forward-looking statements.

You are cautioned not to rely on these forward-looking statements. These risks and uncertainties are described in Chimerix's filings with the Securities and Exchange Commission including the Form 10-Q filed today, it's most recently filed reports on Form 8-K and other documents subsequently filed with the Securities and Exchange Commission.

All forward-looking statements are based on information currently available to Chimerix, and Chimerix assumes no obligation to update any such forward-looking statements. At this time, I would like to turn the call over to our President and CEO, Michelle Berrey..

Good morning, everyone, and thank you for joining us today. The third quarter was another strong quarter operationally for us as we continued to move the organization towards the goal of brining brincidofovir to its first approval and ultimately to patients in need.

With only a few weeks left in 2016 we wanted to share our progress from this year to better understand the results from the SUPPRESS and AdVise studies and cheerfully enter a positive 2017 with several significant catalysts.

Our key driver remains our belief in brincidofovir as the only antiviral that has demonstrated broad spectrum in vitro and clinical activity against multiple DNA viruses.

We remain dedicated to the development of brincidofovir and determining the best routes of administrations to minimize risks and maximize the benefit that we believe brincidofovir can deliver to patients in need. I'd like to share some of our plans for the next 12 months.

The first significant step will be in early 2017 when we share initial data on the IV formulation of brincidofovir from single does in healthy subjects.

Even single dose data will help us determine which IV brincidofovir will provide the same exposure at the oral 100 mg dose and will give us an early read on the ability of the IV formulations to bypass the gut and avoid the associated side effects from oral delivery.

We are including some sensitive markers of bowel injury in our safety assessments that if negative will increase the probability to similar and even higher exposures of brincidofovir will be well tolerated when administered IV.

We plan to use these data to bridge back to the large database's efficacy demonstrated with oral brincidofovir and urgently get back to prevention studies for CMV, adenovirus and other DNA viruses.

Our novel IV formulation of brincidofovir may in fact prove to the optimal way to prevent or treat multiple DNA viral infections by achieving effective drug levels in the plasma and infected organs while avoiding over exposure in the gut and the accompanying gastrointestinal side effects.

Secondly, we recently shared additional learnings from AdVise, specifically the step wise production and mortality observed in pediatric patients throughout the conduct of the study.

The low mortality rates in the pediatric patients who were diagnosed with disseminated adenovirus infection who were quickly treated with brincidofovir reinforced the potential for brincidofovir in patients with this life-threatening infection.

Early identification of adenovirus infection through screening programs and intervention with brincidofovir remain important components of our educational initiative in the U.S. and Europe and are important components as well in our next comparative trial of oral brincidofovir which we expect to initiate in 2017.

Garrett will discuss this comparative study in greater detail later on our call. Third, we are conducting the second animal efficacy study for brincidofovir for the treatment of smallpox the equivalent of a second pivotal trial.

As soon as we have the data, final data in hand, we plan to review these data with the FDA along with the three-week clinical safety data submitted earlier this year. If new additional studies are required we will move forward with our regulatory submission for what could be the first antiviral approved for smallpox.

And finally, we are excited to announce selection of the clinical candidate for the treatment and prevention of norovirus. CMX521 is a nucleoside analog from our Chimerix Chemical Library which should be effective against the diverse norovirus strains associated with human disease.

Linda will provide a brief update on the norovirus market and commercial opportunity and why this is a perfect fit for Chimerix. Finally, Tim will provide a financial review including a strong balance sheet that will allow us to conduct and deliver the potential catalyst that I have mentioned.

We plan to provide additional financial guidance during 2017 once we have clarity on the required next steps and resources needed to advance our program. I'd now like to turn the call over to Garrett Nichols for an update on our clinical program..

Thank you, Michelle. Let's begin with the development of our IV formulation of brincidofovir and the two key reasons that we are so excited about moving this formulation into the clinic.

First, the delivery of brincidofovir directly to blood stream intravenously promises to address the one issue that confounded our Phase 3 SUPPRESS trial, namely the GI side effects of the drug.

In preclinical testing animals given four weeks of IV brincidofovir showed no clinical signs of gastrointestinal injury even with plasma exposures that were several several-fold higher than that was ever achieved with oral dosing. Specifically, these animals had no diarrhea and actually gained weight over the four-week course of the trial.

The absence of GI side effects with IV brincidofovir means the same plasma exposures that were effective for CMV prevention and for the treatment of adenovirus are likely to provide potent antiviral efficacy but without the GI side effects.

Since stem cell transplant recipients are either in the hospital or remain close to the hospital for the first 100 days for this transplant when they are at the highest risk of infection once or twice weekly IV infusions that could potentially prevent reactivation of multiple DNA viruses would represent in advance.

If the clinical studies of IV brincidofovir demonstrates low or no gastrointestinal side effects late stage registrational studies of IV brincidofovir in the prophylaxis setting in stem cell transplant recipients could begin in 2018.

The ability to explore higher exposures in brincidofovir also opens the door for the effective treatment of many viral diseases that we could not treat before. With oral brincidofovir we had a ceiling that was set at the 100 mg twice weekly exposure.

For example, the 100 mg twice weekly oral brincidofovir showed some potential as to prevention for BK virus reactivation but may not have been the right dose to treat and active viral infection such as BK viremia in kidney or stem cell transplant recipients.

IV brincidofovir allows us to explore whether higher exposures can more quickly stop BK replication and have an impact on BK virus associated nephropathy which impacts thousands of kidney transplant recipients every year. More than half of these patients go on to lose their new kidney and return to hemodialysis.

Both BK nephropathy and hemorrhagic cystitis are manifestations of BK reactivation in stem cell transplant recipients and no treatment is currently available for these patients. We hope to initiate studies of IV brincidofovir in these patient populations during 2017.

Higher exposures may also allow the treatment of viruses in anatomic sites that are traditionally more difficult to reach such as central nervous system infections herpes simplex in adults or in newborns or JC virus which is associated with PML in patients receiving immunosuppressive therapies.

As our program progresses through 2017 we hope to explore some of these therapeutic opportunities. Next, let me update you on our adenovirus program. At IDWeek we presented the detail 24-week interim data from the AdVise trial of oral brincidofovir for the treatment of adenovirus infection in allogeneic stem cell transplant recipients.

The AdVise data demonstrated marked declines in adenovirus viremia in both cohorts and cell transplant recipients. In adults and children with asymptomatic or limited adenovirus infection in cohort A 61% had undetectable viremia at the end of treatment.

In adults and children with disseminated adenovirus disease and higher viral loads 49% had undetectable viral loads at the end of treatment. These robust virologic responses were observed even in patients who had delayed or absent immune function after the transplant.

In patients with disseminated adenovirus disease early virologic response to brincidofovir at four or six weeks with associated with improved survival at week-24 in both pediatric and adult patients. But in fact a significant evolution of mortality was observed over the course of the study.

Mortality improved as the trial progressed with the lowest mortality just 14% observed in those pediatric subjects who enrolled in the last quartile of the study. This is very impressive given literature estimates of 50% to 80% mortality with untreated disseminated adenovirus disease.

Shorter times from diagnosis of adenovirus infections to the first dose of brincidofovir are significant drivers of the observed improvement.

With these encouraging data in hand we are finalizing the design of an additional comparative trial of brincidofovir versus standard of care in pediatric stem cell transplant recipients with serious adenovirus infections where the benefits of oral brincidofovir are clear.

We expect this study to initiate during 2017 and we will provide further details once the final protocol is agreed with regulatory authorities. Finally, we plan to present the final 36-week data from the AdVise trial at a medical meeting during the first quarter of 2017.

Increased screening for adenovirus infection in transplant recipients and other high risk populations has allowed for increased recognition of the disease in stem cell [ph] transplant patients and other patients with chronic medical conditions and were a main part of our educational initiative going forward.

Moving to our smallpox development program which we are conducting in collaboration with BARDA. A three-week course of brincidofovir has been proposed for use as a medical countermeasure in the event of a smallpox bio terror attack and is the basis of the oral dosing we are using in the animal efficacy studies for smallpox.

Earlier this year we provided regulators with an in-depth review of the safety and tolerability of a short three-week course of oral brincidofovir in healthy adults and in immunocompromised adults and children.

We have also submitted the final study report from the rabbitpox efficacy study which demonstrated 100% survival in animals that were treated immediately after confirmed pox virus infection.

Following completion of our second animal efficacy study in the mouse model, we plan to meet with the FDA to review the proposed submission of these two animal efficacy studies and discuss any additional data which may be required for a regulatory decision.

Last week we shared these data and an update on our development program at the World Health Organization Advisory Committee on Variola virus research.

Independent of the regulatory considerations the importance of smallpox as a potential bio weapon has been recognized by Congress and we remain hopeful that brincidofovir will be added to our strategic national stockpile once the fiscal year budget is increased for 2017.

Finally, let me update you on the latest candidate from the Chimerix Chemical Library, CMX521 for the treatment of norovirus. CMX521 is a nucleoside analog which targets a part of the virus that is common to all strains. This is important because similar to influenza there are many genetically diverse norovirus strains that circulate each year.

The CMX521 is well tolerated with limited drug interactions. We would pursue prevention of norovirus disease in uninfected individuals during an outbreak. As frequently occurs, in settings as diverse as nursing homes, inpatient hospital wards, military barracks and college dormitories.

We also plan to develop 521 for our primary patient population, transplant recipients and other immunocompromised patients who are at risk from more serious complications of chronic norovirus infection. Now, I'd like to turn the call over to Linda Richardson to discuss why norovirus is such a natural fit for Chimerix.

Linda Richardson Thank you, Garrett and today I'd like to start with some information surrounding norovirus and the opportunities that exist here.

Currently there are no approved therapies to treat or prevent the nearly 700 million norovirus infections that occur globally each year resulting in approximately 220,000 deaths, about a quarter of these in children.

The annual economic total norovirus infections is greater than 60 billion globally of which approximately 4 billion is in healthcare costs and the remaining 56 billion in lost productivity. In the U.S.

alone there are nearly 20 million cases of acute norovirus gastroenteritis annually with most of these outbreaks in healthcare facilities, not cruise ships as you might think from media coverage. The outbreak in healthcare facilities include hospitals, nursing homes and long term care facilities.

Additionally, norovirus outbreaks impact university and military communities where individuals are in close proximity to one another. In fact, in the 2003 to 2004 time period, more than half of U.S. Military personnel in Afghanistan and three quarters of those in Iraq contracted norovirus.

This may be one reason that that the Department of Defense has expressed interest in agents that can prevent norovirus transmission during outbreaks. Moving to specific patient populations of immediate interest to Chimerix, roughly 15% to 20% of stem cell and kidney transplant recipients contract norovirus in the first year following transplant.

Norovirus infection in transplant patients often leads to severe dehydration, malnutrition, chronic diarrhea, and weight loss and can result in gross dysfunction, acute renal failure, organ rejection and even death. Symptoms and viral shedding can last for weeks or months.

Clearly in this vulnerable patient population norovirus infection can be devastating. There are vaccines in development, however, using a vaccine in norovirus may be impractical given the numbers of strains of the virus and the potential for needing an annual vaccination, much like we see with flu immunizations.

Therefore there is a clear unmet need for effective and safe treatment but also to prevent infection in outbreak settings. Elderly patients in particular are at a higher risk of mortality from the infection.

Ideally a drug that could be used to prevent the spread of acute episodes of norovirus infection in non-immunocompromised patients would also be quite valuable in reducing illness and economic burden related to healthcare utilization and loss productivity.

We are currently doing work to better understand the market dynamic and opportunities in norovirus treatment and prevention. I look forward to sharing this information with you in the future. I would like to mention that we are monitoring competitive developments in the CMV adenovirus space.

While CMV remains an important infection in transplantations we know that immunocompromised patients are at risk from may viruses beyond CMV. We previously shared data regarding DNA virus co-infection rates and the early onset of these infections in stem cell transplant patients in particular.

Just two weeks ago at IDWeek additional evidence regarding the need for a broad spectrum antiviral was presented by Dr. Josh Hill and colleagues.

An analysis of over 400 stem cell transplant recipients, from the Fred Hutchinson Cancer Research Center showed that the quantity and duration of viremia for CMV, ADD, EBV, HHV-6 or BK virus correlated with mortality. The authors concluded that better strategies to prevent reactivation of these viruses are needed to improve transplant backups.

Brincidofovir is the only antiviral to show activity against multiple DNA virus in vitro and in vivo. We strongly believe that we have the potential to offer a highly differentiated profile, broad spectrum, potent antiviral activity in a convenient once weekly IV formulation with a high barrier to resistance.

An improved tolerability profile with IV and patent life until 2034 would enable us to build a sustainable development program should result in ongoing sales growth and use in different patient populations. With orphan drug status in Europe for CMV, ADD and now smallpox, the regulatory and reimbursement pathway are favorable.

The treatment of life threatening antivirus infections remains an unmet need and a commercial and clinical priority for Chimerix, one that is simply differentiating for us. BK, EBV and HHV-6 are also common causes of viral infections in solid organ transplantations.

We have previously shared data in both kidney transplant and stem cell transplant recipients that suggest brincidofovir may play an important role in reversing negative impact of BKV in these patients. This again is potentially unique, a novel market segment for brincidofovir that we intend to explore further in our clinical development program.

In closing, we remain enthusiastic about the opportunity for brincidofovir in the marketplace while also preparing for exciting new opportunity to evaluate CMX521 and the possible treatment and prevention of norovirus infections. Now, I'd like to turn the call over to Tim Trost..

Thank you, Linda and good morning everyone. Starting with our balance sheet, on September 30, 2016 we remain well-capitalized with approximately $288 million in capital to fund operations. We also have approximately $46.3 million outstanding shares of common stock.

Turning to our statement of operations, the company reported a net loss of $17 million or $0.37 per basic and diluted share for the third quarter of 2016 compared with a net loss of $32.4 million or $0.70 per basic and diluted share in the third quarter of 2015.

Contract revenue for the quarter was approximately 650,000 as compared with $2.3 million for the same period in 2015 largely due to a decrease in the third quarter of 2016 in reimbursable expenses associated with the company's ongoing development contract with BARDA.

Research and development expenses decreased to $12.2 million for the third quarter of 2016 compared with $26.5 million for the same period in 2015. This decrease was due primarily to completion of the SUPPRESS and AdVise trials and the termination of our two trials SUSTAIN and SURPASS.

General and administrative expenses decreased to $5.8 million for the third quarter of 2016 compared to $8.5 million for the same period in 2015. The decrease results from a $1.5 million decrease in commercial preparation costs and $0.9 million in compensation costs.

Loss from operations were $17.4 million for the third quarter of 2016 compared to a loss from operations of $32.7 million for the same period in 2015 due primarily to the decreased research and development expenses as previously discussed.

As you know from our prior filings and earnings calls, during 2016 while we have been reviewing the results from our earlier trials and advancing both oral and IV formulations of brincidofovir, we've also continued to reduce our costs and conserve the capital up hand.

Specifically in 3Q 2016 we effected a further $2.3 million or 11% reduction of quarterly total operating expenses relative to 2Q 2016. I would like to reiterate our strong balance sheet reflecting $288 million of cash on hand which we believe is sufficient to get us through the near-term milestones that Michelle articulated.

Looking forward, following finalization of intended clinical development plan early next year, we expect to provide 2017 financial guidance at that time. With that, I'd now like to turn the call back to Michelle for final remarks..

Thank you, Tim. We trust this morning's call has provided an informative update on our discovery, clinical and regulatory progress in 2016.

Although we had planned to hold our Annual Investor Update on December 1, we postponed this update until 2017 when we can share data from a single-ascending-dose study and the plans for our next studies in virally infected transplant recipients.

Moving ahead we look forward to achieving a number of value creating milestones such as reporting topline clinical data on our novel IV formulation of brincidofovir in early 2017 followed by more detailed plans for rapid progression of the IV formulation into patients with CMV or BK virus infections.

Finalizing the clinical trial design for adenovirus development program with oral brincidofovir and obtaining regulatory agreement on the endpoints for this study and finally advancing our proprietary nucleosides CMX521 towards the clinic as the first potential antiviral for norovirus prevention and treatment.

As Tim highlighted we have sufficient capital to execute on our short term plans to achieve these important milestones laid out for 2017.

We strongly believe that brincidofovir has the potential to offer a highly differentiated profile, large spectrum potent antiviral activity in a convenient once weekly IV formulation with a high barrier to resistance.

We have an opportunity to build on existing data with oral brincidofovir to get this important antiviral to the market for treatment of life threatening smallpox and adenovirus infections.

With that in projection 3, 20, 34 [ph] and a potentially different profile for IV brincidofovir we have the opportunity to explore treatment of viral infections like BK and JC virus that have continued to negatively impact families and the patients.

As always we thank you for your support and encouragement as we advance brincidofovir and our early discovery pipeline. Operator we will now open the lines for any questions..

Thank you. [Operator Instructions] Our first question comes from the line of Yigal Nochomovitz from Citigroup..

Hi guys, thanks for taking the questions. Garrett, you mentioned in the animal work for the IV study that was with the animals [indiscernible] diarrhea and they gained weight. Additionally did you do any scoping of the animals or look at histology in the G.I. tract to confirm normal tissues? Thanks..

Thanks for your question Yigal. So there was no scoping that was done of the animals during their context of the study. However, the generals worked at a backup price at the end of the four-week period. We also had a recovery group as well.

Histologically there was absolutely amazing results because there just minimal single cell findings in the highest dose group but really didn’t translate into any clinical findings whatsoever in those animals and there were no findings in the mid dose group. So we're very, very encouraged with the results of the histology in those animals.

We're looking very forward to confirming those findings in humans very shortly..

Yes, and on the human studies I think you mentioned that you see the potential for IV brincidofovir to potentially combat BK virus because you may not have been able to get through the therapeutic effect with 100 mg twice weekly.

Can you talk a bit about what modeling work you've done to explore the right doses for the IV formulation and what dose are you actually going to test I the healthy volunteers?.

I think one of the things that's really, that is most encouraging and its - we referred to it in the discussion earlier is that we can explore higher doses. We've always been tapped [ph] in terms of our exposure at the 100 mg twice weekly exposure and so that was as high as we could go.

So we were looking primarily at oral brincidofovir to prevent BK virus reactivation in that setting and as we've discussed before in the stem cell transplant patient there was a transport decreased viremia in the patient's that were treated with brincidofovir in the SUPPRESS study.

But really what we are able to accomplish here with the IV formulation is exploring higher doses.

To your question about modeling, we are working with a number of external investigators that present looking at in vitro work in addition to animal models of BK virus infection to give us more confidence that the doses that we plan to explore will be efficacious. But ultimately the proof will in multiple dose studies in BK virus infected patients..

Okay thanks. And then I think Garrett you mentioned that there were going to be specific safety assessments to prove that they were negative in the healthy volunteer IV trial.

Can you just talk about what specifically you are looking to see there for negative results?.

So we do know that from our single dose studies I humans that when we give for example, higher doses than 200 mg we gave 350 mg in our thorough QT [ph] study and we saw a number of patients developed loose stools in that particular study.

So we do have confidence that as we explore higher doses of brincidofovir, that achieved comparable exposures to the 350 mg if we don’t see GI side effects, that will increase our confidence.

So we're also looking at certain plasma markers of gastrointestinal injury, I think on the lines of sertraline concentrations which is a very sensitive marker for GI injury. In addition plasma cytokines to determine whether there are any subclinical findings, how they could be gleaned from the single dose study.

And we will repeat those measurements in multiple dose studies to come..

Thanks and just sort of one broader question for Michelle or for you, Garrett. Obviously the letermovir's Phase 3 study was successful. Does that in any way change your strategy clinically or commercially for brincidofovir? Could you just speak to that a bit? Thanks..

Yes, you know, I think that we constantly do look at the competitive landscape, but really with our broad spectrum activity we don’t believe that this really changes our plans.

Letermovir is a CMV only product that has a low barrier to resistance and we're looking forward to seeing the complete data with efficacy and a bowel resistance and safety from their Phase 3 study coming up shortly.

But we really do believe that we are well-differentiated in this patient population given that both stem cell and solid organ transplant patients are at risk for not just CMV but multiple double-stranded DNA viruses..

And I think too that their mechanism of action lends itself to prevention only and not treatment and we're not aware also if they have strong data in pediatric patients which clearly we have from our program in adeno and we think that as we've said all along really in the modern day it is beyond CMV in these patients..

Great, thanks very much..

Thank you..

Thank you. And our next question comes from the line of Phil [indiscernible] from Coven and company..

Good morning, thanks for taking my questions.

First a followup to one of Yigal's and that's on the present biomarkers you are looking at in the Phase 1 study, have you ever looked at those for oral brincidofovir and if so, what did you see, what type of elevations in the biomarker?.

No, we haven’t had included biomarkers in our previous program. This is something that we are keen to look at starting in the healthy volunteers without the high rate of GI adverse effects that are commonly present in the stem cell transplant setting.

So this will give us some indications early on as to whether there are any sort of findings that would be subclinical.

But as I said earlier, with higher doses of brincidofovir given orally even single doses were able to be correlated with loose stools and we do believe that that's incented of a biomarkers we need, but we will be looking at more sensitive biomarkers in the clinic as well..

That's helpful and then second on the adenovirus pivotal study, I appreciate that you are still in discussions with the FDA so those aren’t enough, I know, but in the past you've kind of given the broad outlines of what you expected, placebo controlled trial for example, any changes to those broad outlines as you've gone through the negotiation with the FDA or is everything still consistent with your initial expectations?.

No, I think that it is difficult in this setting to do a placebo controlled given the high mortality. We're in a position where a comparison against the standard of care or fast available therapy is the - we've guided before.

We are looking at a pediatric patient population given that the disease is primarily in pediatric patients, stem cell transplant patients and those are the elements that we continue to discuss with regulators from both sides of the pond. So that's the status at present and we look forward to sharing our final trial design in the early part of 2017..

Great, and then one last question on the broader contract, in the prepared remarks, Tim, I think it was you that said, as soon as the budget is finalized for 2017 do you think it is likely that you'll get back contract? How quickly after budget is finalized could the contract come through, is it relatively quicker is there something now that seems very likely something in 2017?.

I'll take that one. We are hopeful where now are the U.S. are currently under a continuing resolution that runs through December 09, we are hopeful that when Congress comes back together that they will finally get to 2017 fiscal year budget, which should have been approved by October 1st when the fiscal year began.

We are – as we mentioned earlier hopeful that final contract will come through in 2017. In general that's a pretty quick process. The thing is we're narrative by that they have set aside. Money is poured to have procurement contract. It is generally a matter of a few weeks. So for that contracts can be finalized.

So we are hopeful that that could be quickly communicated once that budget is finalized where we just continue to have a great unknown is when we'll get a fiscal year 2017 budget or will Congress come back and have another continuing resolution and tell that your administration comes into power in January.

But again, we will certainly be hearing that. The current director of BARDA Richard Hatchett has continued to express this to Congress that getting a procurement contract for brincidofovir for smallpox is one of his top priorities for fiscal year 2017..

That's really helpful, thanks for taking my questions..

Thank you..

Thank you. And our next question comes from the line of David Lebowitz from Morgan Stanley..

Thank you very much for taking my question.

On the post hoc analysis of the adenovirus the patients were – it included patient's who survived beyond week four, how does the data change if the entire data set not just patients survive beyond week four?.

Our landmark analysis is one in which you look at a predictor at a particular time point and then look at subsequent outcomes in those patients. We've looked at it in a variety of different ways.

We've looked at biologic response at week two, because we really do see rapid neurologic responses in these patients and rapid virologic response at week two or at week four or at week six, we're correlating with every subsequent survival, particularly in pediatrics but also in the adult patient population as well.

So it doesn’t matter when you end up looking at this and the patients that have these rapid virologic responses outcomes were better..

Okay, that's great. And then I recall back in May you had indicated that 36-week data where it is going to be available later in 2016.

What types of factors might have caused that data to be I guess held until 2017?.

Well, that was just a decision with regards to conference. The preeminent [indiscernible] conference is the correct target for the sort of presentation and so we're waiting for that conference to occur, that's in February and as soon as that abstract has been accepted then we will have some conformation of that time with the presentation..

Thank you very much for taking my questions..

Thank you and our next question comes from the line of Katherine Xu from William Blair..

Hi this is Audrey on for Katherine.

Did you could say that the mortality rate was different for the first quartile versus the last quartile, the patient has been advised particularly among pediatrics and I was wondering if you could outline what those impediments were that created that delay in the first quartile and how you will ensure more uniformly faster treatment and then trial?.

I think that's a great question. If you will recall back to the time when AdVise was first started we did not have an open expanded access program.

There was no availability of brincidofovir at that time and we had undergone extensive conversations with the FDA about the potential design of a adenovirus trial and had not been able [indiscernible] to agree to a design for that particular study.

The first patient that was enrolled in the trial was a patient who had extensive multi-organ failure had been developed. The [indiscernible] adenovirus was treated with cidofovir.

He has failed cidofovir and had developed renal failure on cidofovir and that a subject of a campaign to pressure our American FDA in order to get to an agreement for that trial.

He was the first patient that was enrolled in this study, but there were other patients that were in similar straight as that first patient that was enrolled in the adenovirus trial with extensive cidofovir treatment in the long distance from their adenovirus, the first dose of brincidofovir.

Again because there wasn’t an expanded access program that was open. If we fast forward to where we are today, we do have an expanded access program open in both Europe and the U.S. In Europe as an mentation program and in the U.S. 3351.

And so patients are able to access brincidofovir and we won't have that warehouse of patients that have extensive multi-organ failure at the time that they receive brincidofovir.

In our comparative study there will be excluding criteria that will also exclude patients that are in multisystem failure from the study so that we can really focus in on those patients that have earlier adenovirus infection and would be most able to respond to either brincidofovir or current available standard of care..

So did you see the same delay with adult patients as well?.

We did, yes we did. We presented the data with regards to the pediatric patient population because that is a large component of the study. .

So why do you think you saw the beneficial effect with pediatrics and not adult?.

Well some of the critiques of the adult populations, adults are not typically screened for adenovirus where as pediatrics patients are screened and so they are able to be recognized earlier. Adult typically are only diagnosed after they develop disease and pretty far along into the disease course where the adenovirus infection is finally recognized.

But as they get spilt biopsy et cetera, pediatric patients are screened more routinely for adenovirus in the blood, in the stool and so they are being recognized earlier..

Yes it's one of the educational points that we hope to make in getting folks to think about adenovirus infections in adults sooner so that they can be diagnosed sooner. We know that they come in late.

And I think one of the points that Garrett was making when we first started this trial it was kind of pulled together very quickly you had to go through IRBs. You didn’t have drug on hand in the beginning.

The folks have been sick for a while and as it was running more like your typical clinical trial and people had experience, you had drug on hand you know intervention could happen sooner. They got drugs on board. There were fewer doses of cidofovir. It was really, I think amazing that you could see 14% mortality in the pediatric population.

It is just something I think is a key learning that we will build into our program and even into our educational work..

Okay, thank you..

Thank you, very much..

Thank you and our next question comes from the line of Josh Schimmer [ph] from Piper Jaffray..

Hi this is [indiscernible] for Josh. Thanks for taking the question.

May be you could just walk us through the rationale for inventing the oral version of brincidofovir for adeno and not just the IV for all applications?.

So, I think that's a nice one as well. You Know I think that with the data that we have in hand from the AdVise study we clearly have demonstrated that with cidofovir has a potent antiviral effect and has benefits over the current standard of care, IV cidofovir in pediatric patients with serious adenovirus infection.

We are providing it now here via name, patient and extended access and we believe that one small study would be sufficient in order to get oral brincidofovir to the market. We will be following up with IV studies.

I think that IV as we end up getting it into multiple dose studies in adults we will be bridging back to the pediatric patients quickly for either the treatment or prevention of adenoviral infection in that particular patient population..

Got it thanks..

Thank you..

Thank you. And our next question comes from the line of Steven Relief from Stiefel..

Yes, good morning. Thanks for taking the questions.

Just wondering if there is any commentary you can make around the pace of compassion that you used to request and are these still mostly adenovirus driven?.

Yes that's the key patient population. So if we look at the main patient program, in Europe in addition to the enrollees in study 351 to date. We've had over 260. We're poised to build this year for adenovirus alone, this far in calendar 2016.

So the demand is there despite the fact that we're really – we're restricting access to those patients with serious adenovirus infection.

So we do get patient's that are past the spectrum with adenovirus we get patients who are sometimes transplant recipients but always [indiscernible] transplant recipients and other patients with immunocompromised condition. So the demand continues with lots of sectors remarking from their perspective brincidofovir has become their standard of care..

Okay, and then just quickly on norovirus, I guess just wondering how wide is the window for norovirus in terms of therapeutic intervention I guess specifically between symptom onset and the ability to have a meaningful impact on transmission and then obviously it is early days with is kind of wondering how you then integrate that into the logistics of a trial design? Thanks..

Yes, great question as well. So the two patient populations that we've been thinking about, number one is our transplant setting where norovirus is associated with chronic diarrhea.

This is for either transplant, stem cell transplant patients or solid organ transplant patients where they can have diarrhea for 200 plus days associated with the condition.

So that's a clear group that is identifiable, is treatable, so that you can decrease the morbidity in some small degree of patient or small number of patients do die of norovirus infection.

So we think that impacting that patient population is a pretty straightforward proposition , You are right that norovirus in the immunocompetent host is typically a self-limited short duration infection and that's treating someone who has acute nausea, vomiting and diarrhea is probably not going to be the way forward.

But norovirus is associated with frequent outbreaks in a variety of different settings including healthcare settings, hospital wards, including nursing homes, military barracks, house dormitories, there's all kinds of settings in which norovirus can basically be responsible for an outbreak.

It is a very hardy virus that is very difficult to get out of a setting once it has been found as has been documented pretty frequently in the cruise ship industry. You definitely don’t want to go in a cruise ship that has recently had norovirus outbreak because it is very difficult to scrub it clean.

But in those types of settings where you have an outbreak being able to use an antiviral to prevent norovirus infection in an uninfected individual who is on the same hospital ward or is on the same nursing home floor has acute outbreak could potentially bridge the patient over and until the setting can be thoroughly cleaned..

Yes, you could use it to prevent infection for example when one family member, small child comes home. If you look at the loss productivity cost, this is where it is happening and the more developed countries, the kid comes home, mom gets it and everybody in the house gets it. Dad can't go to work.

You know you come work, then you spread it to your workplace. Really when there is an outbreak if you could do something to prophylax the other folks from getting it this is a huge opportunity depending upon of course the safety profile of the product and efficacy and at dose could you establish that kind of prevention..

I think it’s a similar type of a process as brain prophylaxis that was employed with the anti-influenza agents with [indiscernible]..

That's helpful. Thanks for taking my questions..

Thank you very much..

Operator:.

So with that I'm going to say a few closing remarks. I just want t thank everybody for joining us on the call this morning. It has been helpful.

Again, we do plan on sharing data from the single ascending dose study for IV brincidofovir every early in 2017 and again we'll be sharing not just the symptoms and plasma concentrations but these other biomarkers that we're using to make sure that we're not getting GI injury.

Again, we'll determine the dose that matches the plasma concentrations that previously showed efficacy and prevention in treatment studies and then that allows us to get back to those prevention kinds of opportunities.

We will also be advancing looking at some of the higher exposures that could get us to a treatment indication for BK, adeno, CMV and other viruses including there is in the CNS.

For oral brincidofovir the bottom line is it works and we have shown a significant impact in reducing mortality in those kids who would have been predicted to have 50% to 80% mortality. We believe that a small comparative study could result in a first approval for treatment for any compounds for adenovirus.

Again, we will be having our second animal efficacy study readout for smallpox and then sitting down with the FDA to determine if any additional work is required and as Tim mentioned we are well capitalized to execute on these plans. Thank you again for joining us this morning and we'll speak with you again.

Operator?.

Thank you. Ladies and gentlemen thank you for your participation in today's conference. This does conclude the program and you may now disconnect. Everyone have a great day..