Michelle LaSpaluto - Senior Director-Accounting Michelle Berrey - President and Chief Executive Officer Tim Trost - Chief Financial Officer Garrett Nichols - Chief Medical Officer.

Samantha Semenkow - Citigroup Phil Nadeau - Cowen and Company.

Good morning. Welcome to the Chimerix Conference Call discussing the Financial Results of the Third Quarter 2018. Please be advised that today’s call is being recorded at Chimerix’s request. I would now like to turn the call over to the Michelle LaSpaluto from Chimerix..

Thank you, and welcome to the Chimerix third quarter 2018 financial results conference call. This morning at 7:30 a.m. Eastern Time, we issued a press release containing the financial results and other updates for the third quarter of 2018. 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; Tim Trost, CFO; other members of the Chimerix management team, including CMO, Garrett Nichols; and Kevin Reeves, VP of Marketing will also be joining us for questions.

Before I begin, I like to remind you that the statements made on today’s call include forward-looking statements within the meaning of the Private Securities Litigation Act of 1995 and are subject to risks uncertainties and other factors, including the possibility that our current or future trials of the brincidofovir may not be successful, that the FDA and other regulatory authorities may not approve brincidofovir or brincidofovir-based regimens, and that marketing approvals, if granted, may have significant limitations on their use.

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

You’re cautioned not to rely on these forward-looking statements. These risks and uncertainties are described in detail in Chimerix’ filings with Securities Exchange Commission, including Form 10-Q filed earlier today.

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 over the call to our President and CEO, Michelle Berrey..

Good morning, everyone, and thank you for joining us today. In mid-October, we held our Annual Investor Update in New York. At this event, we shared our ongoing progress with oral and IV brinci, the small pox program and with our newest molecule, CMX521 for norovirus.

The substantial work over the last three years has set the stage for 2019 to be a transformational year for Chimerix. Specifically, we expect to achieve three significant catalysts in 2019. First, full enrollment of the AdAPT clinical study of short course oral brinci for life-threatening adenovirus infection with data expected in 2020.

These data could lead to regulatory filings later in 2020. Two, clinical data from our ongoing Phase 2 studies of IV brinci designed to confirm the viral decay curves in adenovirus in adult transplant recipients.

This dose confirmation, together with our recently presented confirmation of potent antiviral activity against both BK virus and HHV-6 will inform the design and initiation of our Phase 2/3 studies with IV brinci. Third, animal data from our pivotal rabbit and mouse efficacy studies that could lead to an approval of brinci for small pox in 2020.

At IDWeek in San Francisco in early October, we presented full analyses of measures of adenovirus viral load from the AdVance study. A correlation of six different viral load measures of adenovirus and all-cause mortality showed that patients with the highest adenovirus viral burden had the highest risk of mortality.

Importantly, adenovirus peak and persistence each have an impact on mortality. Patients with high peak viral loads and those whose viremia does not clear quickly under currently available therapy have a higher risk of dying.

The benefit of the adenovirus average Area Under the Curve or AUC is that it encompasses both the peak viral load and the persistence of viremia with each one log increase in the adeno AUC in AdVance, the risk of mortality doubles.

Patients in the highest quartile of adeno AUC had over a 10-fold increased risk of death in the next six months, other than those patients in the lowest quartile of adeno AUC.

With such a strong correlation between adenoviral burden and mortality, an antiviral that’s able to lower the peak and shorten the duration of adenoviremia should lead to improved survival. The AdAPT study is powered to demonstrate the superior ability of brinci to rapidly lower the adenoviral load and shorten that duration of viremia.

This is expected to result in a smaller Area Under the Curve for patients on brinci, compared with those on the currently available therapy. We know this because, Area Under the Curve was associated with mortality in that AdVance dataset and other independent datasets meaning a bigger Area Under the Curve which is a higher risk of mortality.

Thus, a lower adeno Area Under the Curve in patients on brinci from the AdAPT study should result in improved survival. With these data in hand, we plan to request a Type C meeting with the FDA to discuss adeno AUC as a potential surrogate marker.

FDA only recently announced the potential for Type C meetings to facilitate consideration of surrogate markers for an accelerated approval. In addition to the AdVance data, three additional independent datasets from transplant centers in Austria, New York and the UK have confirmed the same strong correlation as adeno AUC and mortality.

These datasets and prospectively randomized clinical trial data from AdAPT could lead to approval of oral brinci in both the U.S. and Europe. Remember, our regulatory strategy is to advance short course oral brinci under a treat to clear paradigm for the treatment of adenovirus.

As a first indication, this would support a value proposition in the setting of a life-threatening viral infection. With initial revenues generated in adeno infections, we can build an early commercial foothold in the same transplant centers we’ve been working in for years.

The revenues from oral brinci for adeno will allow us to advance multiple development opportunities for IV brinci, the land and expand strategy. Turning to IV brinci we are continuing to open clinical sites for our Phase 2 studies in the U.S. and Europe.

At IDWeek, we presented data from our Phase 1, multiple ascending dose study of IV brinci in healthy adult subjects which evaluated the safety and pharmacokinetics of four doses of IV brinci.

10 milligrams of IV brinci provided similar blood levels as 100 milligram oral doses studied in late-stage clinical trial with no diarrhea or other GI adverse events reported.

Our Phase 2 studies in adult stem cell transplant recipients are starting with this 10 milligram IV dose and will allow us to confirm the safety tolerability and pharmacokinetics of IV brinci in a virally-infected patient population and importantly allows us to confirm whether this dose provides the same viral decay curves that we’ve seen in over 1500 patients that have received brinci for the treatment of adeno infection.

We look forward to sharing safety, PK and viralogic response curves from these trials as they become available in 2019.

In October, at the American Society of Nephrology ‘s Kidney Week at San Diego, we presented data from two mouse efficacy studies of polyomaviruse infection, which demonstrated that BK beat to brinci significantly reduced the viral load at virus in the same family as BK and JC virus.

At our Investor Event, we presented data from the SUPPRESS study that showed significant activity of brinci against HHV-6 infection in stem cell transplant recipients.

The data from our ongoing Phase 2 IV brinci studies, combined with the recent BK and HHV-6 data will inform the designs of our Phase 2/3 studies for IV with brinci which we plan to progress in 2019. Our small pox development program is also progressing with both the ongoing rabbitpox efficacy model and we are finalizing the mousepox protocol.

We are pleased to see BARDA has been approved for funding under the PAHPA re-authorization with our anticipated animal data from our adjunct pivotal rabbit study in mousepox model in 2019. We should have increased clarity on a potential procurement contract next year as well.

And last, we are pleased to share the data from the CMX521 program for norovirus infection. In late September, we presented the safety and tolerability data from the single-dose administration of oral CMX521 at the European Society for Clinical Virology in Athens, Greece.

Single doses of the compound up to 2400 milligrams with top dose study were well-tolerated.

Work is ongoing with in vitro models of norovirus infection that should help us further understand the pathophysiology of norovirus, data from the ongoing Phase 1 studies and the assessment of different formulations of CMX521 will help determine the dose and formulation with the highest probability of success to be carried forward into a proof-of-concept study.

With that, I’ll turn the call over to Tim for a review of our financials. .

Thank you, Michelle, and good morning everyone. As Michelle LaSpaluto mentioned in her introductory remarks, earlier today, we issued a press release containing our financial results for the third quarter of 2018.

Starting with our balance sheet, at the end of third quarter 2018, we remained well-capitalized with approximately $194 million in capital to fund operations, no debt, and approximately 50.6 million outstanding shares of common stock.

Turning to our statement of operations, the company reported a net loss of $16.1 million or $0.33 per basic and diluted share for the third quarter of 2018, compared with a net loss of $17.3 million or $0.37 per basic and diluted share in the third quarter of 2017.

BARDA contract revenue for the quarter was approximately $0.4 million, as compared with $0.9 million for the same period in 2017.

Research and development expenses for the third quarter of 2018 were similar at $11.9 million, compared with $12.2 million for the same period in 2017 with increased expenses in the clinical programs, offset by a decrease in compensation expense.

General and administrative expenses decreased to $5.2 million for the third quarter of 2018, compared to $6.7 million for the same period in 2017, primarily due to a decrease in compensation expense. Loss from operations was $16.7 million for the third quarter of 2018, compared to a loss from operations of $17.9 million for the same period in 2017.

And lastly, although we continue to expect R&D expenses for the full year 2018 to trend upward from 2017, we remain committed to focus on cost control. Before turning the call back over to Michelle, I’d like to again emphasize two points. Number one, our strong cash position and number two, the Chimerix employee commitment.

First, our strong balance sheet. At the end of 3Q, we reflected a $194 million in available capital. During the third quarter of 2018, we issued shares under our ATM program raising a total of $10.5 million net of fees.

We may continue to utilize the ATM opportunistically from time-to-time depending on market conditions as a way to bolster our cash position and offset cash burn. Second, and a significant point regarding the confidence and commitment of Chimerix employees.

As you can see from the financing activities section of our cash flow statement, employees have invested over $700,000 in Chimerix year-to-date between the employee stock purchase plan and option exercises. With that, I’d now like to turn the call back to Michelle for final remarks. .

Thank you, Tim. In closing, we are excited about the progress in AdAPT enrollment with two additional countries, Italy and Germany soon joining the pediatric centers participating in the AdAPT study.

We anticipate full enrollment of AdAPT in 2019 and believe we will be able to provide more specific guidance after a couple of months of screening and enrollment with nearly all the 38 targeted sites enrolling.

IV brinci, the basis for the long-term value of brincidofovir, is completing the final confirmatory steps in the Phase 2 studies in adeno and we expect we will be beginning a dose range study for BK virus in kidney transplants in 2019.

We are also excited about the potential for IV brinci to address viral infections in the CNS of patients with compromised immune systems supported by the new data on the prevention of HHV-6 viremia in our SUPPRESS study.

With the improved exposure to the CNS seen in animal studies, IV brinci maybe the key to unlock the full potential of brinci in these patient population. 2019 is expected to bring clarity to the procurement opportunity for small pox and will bring final efficacy data on both the rabbitpox and mouse models enabling regulatory submissions in the U.S.

and Europe and potentially much more wide ranging commercial opportunities in the U.S. and beyond. With that, operator, we will now open the line for any questions..

[Operator Instructions] Thank you. And our first question will come from Yigal Nochomovitz with Citi. Your line is open. .

Hi, this is Samantha on for Yigal. Thanks for taking our question. You previously mentioned before that, is the possibility for accelerated approval for oral brinci based on the AdAPT data, and that full approval could be based on the data from the IV brinci studies.

First, is this still your thinking around the adenovirus program? And second, is there a precedence for gaining full approval with a different formulation and whether the accelerated approval was based on from the FDA?.

So, this is Garrett Nichols.

As far as the strategy, yes, these is our current strategy for us to submit the AdAPT data together will all the data that we’ve compiled outlining the natural history of adenovirus in this transplant patient population be it the AdVance study and other supporting datasets, that’s a pretty strong package of information and if we are able to show numeric advantages to mortality in addition to achieving a lower adenovirus viral burden with brinci oral when compared to the standard of care.

But that would really fit at all for a accelerated approval and also for approval in Europe. As far as confirmatory trial is concerned, we have thought of using the IV formulation for confirmation. Essentially, it’s the same molecule.

It’s just a different formulation and don’t believe that that should be an issue just from switching formulations from oral to IV. .

And are you aware of any precedent where this has been done before this, the FDA has accepted a different formulation knowing your – that you aren’t aware of any potential issues that fits in Europe?.

I am not sure there is a precedent for oral versus IV. But if you look at addition of different formulations to a package of pre-existing approval, in general those require a smaller number of individuals. So, we don’t even write to the same threshold of proof as a second confirmatory study. Generally, it can be conducted even with just PK studies.

So as Garrett saw that, we don’t anticipate there will be any issue, but that’s certainly a topic that we would expect could come up in the Type C meeting that we are planning on holding regarding the surrogate marker.

Just also want to mention, if we do see a statistically significant improved survival from the AdAPT study, that would suffice it for a full approval, not a sub-part. So we will really have more information with – data from the AdAPT study and that will allow us to see which options we want to pursue and which order for the IV. .

Great. Thank you. That’s very helpful. And also….

Do you have another question?.

Yes. So, the KOL at your R&D Day in October, he mentioned that if brinci were to gain FDA approval in adenovirus, he would proceed to use it off way both to treat other DNA viruses.

I was wondering in your discussions with other KOLs in the space, have you gotten the impression that his sentiment are shared with his peers?.

Well, we do know that the brinci expanded access program in the 2014 time period which was available for treating a number of different double-standard DNA viral infections that the volume of requests for viruses, other than adenovirus was pretty robust.

Certainly, there is plenty of interest in treating HHV-6, in treating BK virus and some viruses that are less common, but certainly problematic in this patient population such as resistant herpes simplex virus, resistant refractory cytomegalovirus and JC virus as well.

So, all of this treatment opportunities are certainly things that physicians are interested in using brinci primarily because there is really not much else available for treatment of those particular conditions and therefore, these physicians are very familiar with going to their pharmacy and accessing drugs that have demonstrated activity either in vitro or in case studies and there is a lot of – plenty of case experience that has been published with brinci with several of these different viruses.

We attempt to take – start to compile those experiences for your reference in slides that we presented at the investor event..

Okay. Thanks much for taking the questions. .

Thank you. And our next question comes from Jessica Fye with J.P. Morgan. Your line is open. .

This is Daniel for Jessica. Thanks for taking our question.

Besides the go-forward dose, what should we expect to learn from the in vitro study in animal model that should design the late-stage in human study? And maybe could you provide us with the timeline with the next human studies of CMX521?.

So, I think I heard the question. You were breaking up a little bit on the line. But the question that I heard was related to CMX521 and the information that we expect to get from some of the in vitro and animal work.

Is that correct?.

Yes. .

Okay. So, we have tested oral CMX521in single ascending doses up to 2.4 grams in healthy volunteers and demonstrated as we expected that increasing doses are also seeded with increasing exposure in the plasma.

But remember that the target tissue as far as norovirus is concerned, it’s actually the gastrointestinal mucosa, that’s where norovirus replicates and we can best get an idea about the level of CMX521 that are able to achieve therapeutic efficacy in some very new human enteroid cell.

These are biopsies taken from human, grown up and cultured and those secular cultures are able to replicate what the gut mucosa looks like in, in vivo. We can basically do all kinds of experiments including introducing norovirus into those cultures.

We can look at the effects of drugs in those cultures and those are some of the experiments that are ongoing now.

So, as we look at the levels of drugs that we are able to achieve in those enteroid models, we are able to better pick dose and formulation that will inform our proof-of-concept study which is the next step as far as human study is concerned. .

All right. Thank you..

Thank you. [Operator Instructions] Our next question comes from Phil Nadeau with Cowen and Company. Your line is open. .

Good morning and thanks for taking my questions. Michelle, a question on the Type C meeting that you referenced in regards to a prior question.

Do you have a sense of when that meeting would be? Have you requested the meeting or have a specific timeline as to when you hope to have that completed?.

Yes, thanks for the question, Phil. I think, our best guess literally, relatively early in 2019. We have informed the FDA that we are going to be requesting that meeting. But that requires a pretty robust briefing package that would include all the AdVance data that we just recently presented at IDWeek, as well as those other independent datasets.

So, as we are compiling all of that getting that briefing package ready that will go in with a formal meeting request. It’s a 75-day meeting request. So, that would put us pretty early in 2019. .

In the independent datasets, do you have access to all that information? Or is there additional results that you need to give?.

That information is being published. I think one of the first presentations of that information was by Dr. Papanicolaou from The Sloan Kettering Center in New York.

That was the IDWeek as well, she and her colleagues presented the data from their center and then we have been working with The Manchester Center and with Thomas Leone in Austria to look at their data.

The importance of those datasets is that, all of them were conducted with the same quantitative PCR assay used in the same monitoring, prospective monitoring plans. These are centers that have been doing this now for well over a decade.

And so, they are able to replicate what we ended up seeing in the AdVance study, but in a much more homogenous patient population. That kind of distinguishes it from AdVance which is a heterogeneous population, but it’s a population of 50 transplant centers across Europe.

So this really helps to kind of compare and contrast to provide the same information or at least the same conclusions that the adenovirus viral burden is significantly associated with mortality after stem cell transplant. .

Got it. Okay, fair enough. Thanks for taking my questions. .

Thank you. .

Thank you. I am showing no further questions at this time. I would now like to turn the call back to Michelle Berrey, President and CEO, for closing remarks..

Thank you everyone for your time this morning and we look forward to providing with additional updates in the coming months. Good bye. .

Ladies and gentlemen, thank you for participating in today's conference. This does conclude the program and you may all disconnect. Everyone, have a great day..