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Edited Transcript of CMRX earnings conference call or presentation 5-Mar-19 1:30pm GMT

Q4 2018 Chimerix Inc Earnings Call

Durham Mar 26, 2019 (Thomson StreetEvents) -- Edited Transcript of Chimerix Inc earnings conference call or presentation Tuesday, March 5, 2019 at 1:30:00pm GMT

TEXT version of Transcript

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Corporate Participants

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* Michelle LaSpaluto

Chimerix, Inc. - Executive Director of Financial Planning, Analysis & IR

* Timothy W. Trost

Chimerix, Inc. - Senior VP, CFO, Corporate Secretary & Office of CEO

* William Garrett Nichols

Chimerix, Inc. - Chief Medical Officer & Office of CEO

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Conference Call Participants

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* David Neil Lebowitz

Morgan Stanley, Research Division - VP

* Edward Patrick White

H.C. Wainwright & Co, LLC, Research Division - MD of Equity Research & Senior Healthcare Analyst

* Katherine Xu

William Blair & Company L.L.C., Research Division - Co-Group Head of Biopharma Equity Research, Partner & Biotechnology Analyst

* Philip M. Nadeau

Cowen and Company, LLC, Research Division - MD and Senior Research Analyst

* Samantha Lynn Semenkow

Citigroup Inc, Research Division - Senior Associate

* Stephen Douglas Willey

Stifel, Nicolaus & Company, Incorporated, Research Division - Director

* Yuko Oku

JP Morgan Chase & Co, Research Division - Analyst

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Presentation

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Operator [1]

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Good morning. Welcome to the Chimerix conference call discussing the financial results of the fourth quarter and year-end 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 Michelle LaSpaluto from Chimerix.

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Michelle LaSpaluto, Chimerix, Inc. - Executive Director of Financial Planning, Analysis & IR [2]

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Thank you. And welcome to the Chimerix Fourth Quarter and Year-End 2018 Financial Results Conference Call.

This morning, at 7:30 a.m. Eastern time, we issued a press release containing the financial results for the fourth quarter and year-end 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 2 hours after the conclusion of the event.

With me on today's call are members of the Office of the Chief Executive: Garrett Nichols, Chief Medical Officer; Tim Trost, Chief Financial Officer; and Michael Alrutz, General Counsel.

Before we begin, I'd like to remind you that the statements made on today's call include forward-looking statements made within the meaning 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 marketing approval, if granted, may have significant limitations on its use. As a result, brincidofovir may never be successfully commercialized. In addition, Chimerix may be unable to file for regulatory approvals of brincidofovir with other regulatory authorities.

These risks and uncertainties and other factors could cause the actual results to differ materially 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 detail in Chimerix's filings with the Securities and Exchange Commission, including the Form 10-K filed today, its most recently filed reports, 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'd like to turn the call over to our Chief Medical Officer, Garrett Nichols.

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William Garrett Nichols, Chimerix, Inc. - Chief Medical Officer & Office of CEO [3]

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Thanks, Michelle. Good morning, everyone, and thank you for joining us.

It's a pleasure to be reporting the important progress that we've made throughout 2018 and to discuss with you our plans for 2019. As you know, we've had a change within our leadership team with the establishment of the Office of the Chief Executive Officer, which consists of Tim Trost, Michael Alrutz and me. Over the year, we have built a strong, cohesive team. Together, we continue to prioritize the advancement of our clinical development pipeline, which we continue to believe is the core to our success, but let's turn to the advancements we've made across our brincidofovir programs.

I'll begin with our smallpox program. In 2018, we made meaningful progress by initiating our second rabbitpox efficacy study with brinci conducted under the FDA's Animal Efficacy Rule. As you may know, this rule allows for testing of investigational drugs in animal models to support the effectiveness of a drug in diseases in which human clinical studies are not ethical or feasible.

Today, I'm excited to report that the study met its primary endpoint of overall survival compared with placebo. Specifically, survival in groups of rabbits who initiated treatment with oral brincidofovir 3, 4, 5 and 6 days after being infected with rabbitpox virus were all significantly higher than those treated with placebo. 100% of the rabbits treated with brincidofovir 3 days' post infection survived, while only 29% of the rabbits that were not treated with brincidofovir survived. Importantly, brinci showed efficacy even several days after the onset of symptoms in these animals, which is important for a smallpox antiviral. And data from the study are consistent with those reported from our first pivotal rabbitpox study conducted in 2015.

In February, we also initiated a pivotal study in the mouse ectromelia model, which constitutes the second animal model as required by the Animal Efficacy Rule. Data from this study is anticipated later this year. Assuming positive data from this final mouse study, alongside the strong survival data from our rabbit studies, we intend to submit marketing applications for approval in 2020. These data also position us well for continued discussions with BARDA regarding the potential for emergency stockpiling of oral brincidofovir as we advance this program towards regulatory approval.

Turning now to our brincidofovir clinical programs, I'll begin with our AdAPT study, which plans to enroll 141 pediatric allogeneic hematopoietic stem cell transplant recipients with confirmed adenovirus infection. In this study, patients are being randomized 2 to 1 to receive short-course oral brincidofovir or local standard-of-care treatment at approximately 40 sites in Europe and the United States.

Based on a thorough reevaluation of current screening and enrollment rates, we now project that enrollment in the AdAPT study will be substantially delayed beyond 2019. While some recently initiated sites have been historically more active in transplantation and could yield an uptick in recruitment rates, we continue to evaluate strategies to accelerate the time to completion of the study, including the opening of further AdAPT sites and potentially reconsidering the targeted number of patients for full enrollment. Once we've had all of our sites up and running for a few months, we will be in a better position to project the time to study completion. We thus plan to provide an update on AdAPT enrollment in mid-2019.

In the meanwhile, we continued to open sites in both the United States and Europe, including several large sites in Italy and the Netherlands. By the end of this month, we hope to have an additional 4 U.S. sites; 2 additional Italian sites; and one additional site each in France, Poland and Germany open for enrollment. Many of these sites have contributed a large volume of patients in the AdVance study, so we look forward to their contribution to study recruitment.

Having just returned from the transplantation and cellular therapy meetings, formerly known as the tandem BMT meetings, we were encouraged by the continued strong support from our investigators in the transplant community, who reiterate the importance of this trial and of brincidofovir for the treatment of their pediatric patients with serious adenovirus infections. We also submitted a request for a Type C meeting with the FDA to discuss the primary endpoint of AdAPT, adenoviral burden, as a potential surrogate marker for mortality.

Recall that the primary endpoint of the AdAPT study is a comparison of the average adenovirus viral burden as measured by adenovirus DNA levels in blood over 16 weeks in subjects treated with short-course oral brinci versus those who receive local standard of care. The study is also evaluating the correlation of adenovirus burden and its clearance from the blood with clinical outcomes, including survival. At this Type C meeting, we intend to share the full results from AdVance, the largest multicenter observational study conducted to date for adenovirus infection, after allogeneic stem cell transplant which was just published in the journal Bone Marrow Transplantation.

This study established outcomes associated with the current standard of care for treatment of adenovirus in France, Germany, Italy, the Netherlands, Spain, the Czech Republic and the United Kingdom. We believe that the strong correlation demonstrated between adenovirus burden and mortality will help to support the virologic endpoint in AdAPT and the suitability of AdAPT to support accelerated approval in the United States.

Finally, turning to our IV brincidofovir program in adenovirus infected patients. As with the AdAPT study, we have faced similar issues for studies 210 and 211 that have resulted in slower-than-anticipated enrollment rates. We plan to provide a study update in mid-2019. Recall that the primary objectives for these first inpatient IV studies are to demonstrate the safety and tolerability and pharmacokinetic profile of multiple doses of IV brinci in adult transplant recipients with adenovirus infection.

These studies have the potential to show what IV brinci dose is associated with antiviral activity against adenovirus and could also provide data on other viral infections such as CMV and/or BK virus in patients with multi-viral infections. Importantly, data from these studies will inform the dose and dosing regimen for our potential multi-viral protection or MVP-peds study and potential studies of IV brinci for other DNA viruses such as BK or HHV-6.

Just a few weeks ago, at the transplantation and cellular therapy meetings, we presented data that showed that brinci reduced the reactivation of HHV-6 following stem cell transplantation. In a post-hoc analysis of our Phase III study, we analyzed plasma samples of 153 patients who did not have HHV-6 at baseline and received at least 6 doses of brinci or placebo.

Almost 1/3 of the patients on placebo had detectable HHV-6 compared to only 15% of patients who received brinci. In addition, both rash and HHV-6 encephalitis were less common on brinci than on placebo. The study suggests that brinci could be used as a preventative treatment for HHV-6 after stem cell transplantation. We plan to further investigate these findings and the impact that this could have on the IV program.

With that clinical overview, I'll now turn the call over to Tim for a review of the financials.

Tim?

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Timothy W. Trost, Chimerix, Inc. - Senior VP, CFO, Corporate Secretary & Office of CEO [4]

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Thank you, Garrett. And good morning, everyone.

As Michelle mentioned in her introductory remarks, earlier today, we issued a press release containing our financial results for the fourth quarter and year-end 2018.

Starting with our balance sheet, at the end of 2018, we remained well capitalized with approximately $186 million in capital to fund operations through the end of 2021. Note, this financial projection is based solely on continuing our ongoing clinical trials and nonclinical development program and could change to reflect any modifications to these activities. We also had approximately 50.7 million outstanding shares of common stock.

Turning to our statement of operations, the company reported a net loss of $15 million or $0.29 per basic and diluted share for the fourth quarter of 2018 compared with a net loss of $19.2 million or $0.41 per basic and diluted share in the fourth quarter of 2017. Contract revenue for the quarter was approximately $4.9 million, as compared with $1.8 million for the same period in 2017, largely due to an increase in the fourth quarter of 2018 in reimbursable expenses associated with the company's ongoing development contract with BARDA.

Research and development expenses increased to $15.3 million for the fourth quarter of 2018 compared with $12.9 million for the same period in 2017. This increase was primarily due to the ongoing animal studies under the smallpox program. General and administrative expenses decreased to $5 million for the fourth quarter of 2018 compared to $7.6 million for the same period in 2017. A few key components of the decrease in expense were reductions in commercial preparations, compensation and legal expense.

Loss from operations was $15.4 million for the fourth quarter of 2018 compared to a loss from operations of $18.7 million for the same period in 2017, the change being primarily due to the increase in revenue, as previously discussed.

Looking forward to the full year 2019, we currently expect both R&D and G&A expenses to remain consistent with 2018, although there may be unevenness from quarter to quarter.

With that, I'd now like to turn the call back to Garrett for final remarks.

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William Garrett Nichols, Chimerix, Inc. - Chief Medical Officer & Office of CEO [5]

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Thank you, Tim.

So to recap. We are pleased to announce the top -- positive top line data from our rabbitpox study and look forward to sharing top line data from our final pivotal study in the mouse model later this year. We continue to advance both oral and IV brinci, to the benefit of patients suffering from adenovirus and a broad spectrum of other viral infections for which there are limited treatment options. We've submitted a Type C meeting request to the FDA to discuss surrogate endpoints in our AdAPT study, with the expectation for that meeting to occur in the second quarter of this year.

With that, operator, we'll now open the line for any questions.

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Questions and Answers

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Operator [1]

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(Operator Instructions) And our first question is from Katherine Xu from William Blair.

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Katherine Xu, William Blair & Company L.L.C., Research Division - Co-Group Head of Biopharma Equity Research, Partner & Biotechnology Analyst [2]

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So I'm just wondering with both oral pediatric brinci study and also the adult IV studies are delayed, just curious. Is it a general kind of just overoptimism on the planning side? Or is it something that -- about adenovirus this season or in recent months have changed? Just curious about some more details on the delay.

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William Garrett Nichols, Chimerix, Inc. - Chief Medical Officer & Office of CEO [3]

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Thanks, Katherine. I -- it's not any one specific thing. We have definitely experienced regulatory delays. We are still opening sites in Europe and the United States. Delays in securing regulatory approval, with no 1 particular question predominantly really being questions that address different parts of the program and/or the formulations.

And then with regards to adenovirus infections, the sites that have been opened have experienced a lower-than-expected incidence of adenovirus infections. And there's really nothing that they say has changed with regards to their practices in terms of screening for patients. They're looking actively for adenovirus infections, but they're experiencing lower rates of adenovirus infections than they have in previous years. So we're trying to get a grip on that. That does not appear to be a factor that has affected the ongoing compassionate use program where we've had stable incidence and requests for adenovirus requests. And of course, we also track adenovirus in the community, which doesn't appear to be different.

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Operator [4]

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Our next question is from Yigal Nochomovitz from Citi.

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Samantha Lynn Semenkow, Citigroup Inc, Research Division - Senior Associate [5]

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This is Samantha on for Yigal. Just a bit of a follow-up there. So you're seeing these hurdles you've just listed globally both in the U.S. and Europe.

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William Garrett Nichols, Chimerix, Inc. - Chief Medical Officer & Office of CEO [6]

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So as far as the regulatory approvals, the regulatory approvals in Europe have been slower than anticipated. We've had some delays at a variety of different countries. And we have countries that are now -- just now coming onboard and will be coming onboard within the next month. As far as the incidence is -- was mentioned, of the sites that currently are enrolling in the study, they have experienced lower than previous years' incidence of adenovirus. This is not necessarily across the board but across the study sites. It's just a lower-than-expected screening and enrollment rate. And we're -- we continue to explore reasons for that. The sites have said that they're not doing anything different in terms of their practices, so we're trying to understand the reasons behind the lower-than-expected incidence.

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Samantha Lynn Semenkow, Citigroup Inc, Research Division - Senior Associate [7]

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Got it. And you mentioned that some of the sites that are coming onboard, hopefully, this month were some of the larger sites to participate in AdVance. Is -- the reason these sites maybe weren't initiated earlier, does that have to do with some of these regulatory hurdles? Or has that a different reason altogether?

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William Garrett Nichols, Chimerix, Inc. - Chief Medical Officer & Office of CEO [8]

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No, that's correct. That's correct. It's just the countries that have longer-than-usual regulatory cycles. You'll recall that we ended up doing country-based submissions for these studies, and each country has its own regulatory process. Once the regulatory process is complete, then we usually have to go through sequentially final contract agreements with the sites. So that also delays site initiation.

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Samantha Lynn Semenkow, Citigroup Inc, Research Division - Senior Associate [9]

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Got it. That's helpful. And then on the Type C meeting, has the FDA provided you any comments now that you've requested the meeting officially after you've done the submission? And following the meeting, when should we expect an update? Will it be presumably soon after the meeting? Or do you expect to wait for minutes? Or will there be some ongoing dialogue between you and the FDA that you expect to complete first?

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William Garrett Nichols, Chimerix, Inc. - Chief Medical Officer & Office of CEO [10]

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So the meeting typically occurs 75 days after the submission of the briefing package. We've submitted a complete briefing package with our questions to the FDA. We generally don't engage in dialogue with them beforehand. So the meeting would occur 75 days after the submission of the meeting (sic) [package]. Just to set expectations, the FDA is not likely to provide a black-and-white answer with regards to the program. This is really about engaging in dialogue and providing all of the evidence that we've accumulated to date on the adenovirus viral burden endpoint of the AdAPT study, its correlation with mortality not just in the AdVance data set but also in a number of independent data sets which are moving forward towards publication this year.

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Operator [11]

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Our next question is from David Lebowitz from Morgan Stanley.

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David Neil Lebowitz, Morgan Stanley, Research Division - VP [12]

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With respect to the animal studies and the resulting FDA submission next year, could you just run us through what items beyond this animal data you need to put together and what other limiting factors there might be?

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William Garrett Nichols, Chimerix, Inc. - Chief Medical Officer & Office of CEO [13]

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So the pivotal animal studies are in the 2 animal models. The first is the rabbitpox model. The second is in the mousepox or ectromelia model. So the important pieces are the results of those studies. You need to demonstrate efficacy in those 2 animal models. Obviously, there's a lot more to be put into a package of information that goes to the FDA, including how the drug behaves in humans, so there's a number of healthy-volunteer PK studies that need to be included in that particular piece, the description of the safety of the drug and then also the bridging between the animals and the humans in terms of drug exposures.

Those are the key pieces for us to provide. Once we have the pivotal animal models, in general those pivotal studies undergo audit by the FDA and then are followed by a final report. And that can take up to a year for those particular pieces to come through, which accounts for the time between the data that's available from our final animal model in the mouse to the time that we can actually submit the data to the FDA.

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Operator [14]

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Our next question is from Stephen Willey from Stifel.

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Stephen Douglas Willey, Stifel, Nicolaus & Company, Incorporated, Research Division - Director [15]

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I know one of the levers you mentioned being able to pull here to accelerate time lines is reconsidering the number of patients required for full enrollment. Do you have any regulatory feedback in hand regarding minimal number of patient exposures? And I guess, if not, do you intend to seek this type of guidance out over the coming months?

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William Garrett Nichols, Chimerix, Inc. - Chief Medical Officer & Office of CEO [16]

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Yes, thanks for the questions, Steve. I mean, to be clear, no decisions to change the size of the trial have been made. We're just saying that we're considering all of our options to accelerate the time to completion, but we have said frequently that this study is overpowered for the primary endpoint. And we upsized the study in order to have as much data as we possibly could for the safety and the mortality piece of the endpoint as well. Should we decide to address a smaller sample size, as far as the study is concerned, we would likely get regulatory feedback before we did so.

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Stephen Douglas Willey, Stifel, Nicolaus & Company, Incorporated, Research Division - Director [17]

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Okay. And I know the Type C meeting is really a discussion about endpoint selection, but is there any way that you could potentially solicit some feedback from FDA regarding what that patient number might or could be?

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William Garrett Nichols, Chimerix, Inc. - Chief Medical Officer & Office of CEO [18]

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Yes, depending on the type of dialogue that we end up having with the FDA, that could be an opportunity for us to do so, yes.

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Operator [19]

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Our next question is from Ed White from H.C. Wainwright.

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Edward Patrick White, H.C. Wainwright & Co, LLC, Research Division - MD of Equity Research & Senior Healthcare Analyst [20]

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So first, on the rabbitpox study. When was that study initiated? And when did you get the data? I'm just looking at the time line there and wondering if it could be extrapolated to the mouse study.

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William Garrett Nichols, Chimerix, Inc. - Chief Medical Officer & Office of CEO [21]

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Well, the rabbitpox study in terms of the number of animals that we have to treat in that study is smaller, so it doesn't necessarily extrapolate directly, but that said, it was started in December. And we got data last month from that particular study. So the mouse study was started in February, and it will be a couple of months before we end up getting the in-life portion of that study reported.

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Edward Patrick White, H.C. Wainwright & Co, LLC, Research Division - MD of Equity Research & Senior Healthcare Analyst [22]

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Okay. And looking just back to the AdAPT, you had mentioned approximately 40 sites, and you have new sites coming online by the end of this month. Can you tell us how many sites are currently enrolling patients?

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William Garrett Nichols, Chimerix, Inc. - Chief Medical Officer & Office of CEO [23]

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Yes. So we have approximately 32 sites that are open and enrolling at this point. And we have an additional 8 sites that are slated to open within the next months.

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Edward Patrick White, H.C. Wainwright & Co, LLC, Research Division - MD of Equity Research & Senior Healthcare Analyst [24]

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Okay. And then lastly, just on CMX521 in norovirus, can you give us an update there and when we can expect to see patients being enrolled in the multiple ascending-dose study? And trying to get some timing to maybe the start of the Phase II study.

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William Garrett Nichols, Chimerix, Inc. - Chief Medical Officer & Office of CEO [25]

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In our press release prior to the JPMorgan conference, we announced that we had received part B of that first-in-human study, which was a study that conducted single doses of 521 in healthy volunteers. And then we obtained gastrointestinal biopsies from those individuals. Unfortunately, in that study we found that the levels of 521 triphosphate, which is the active drug, were below the levels that we believe would be efficacious. And so we're examining our options, as far as formulation work, et cetera, for us to be able to move forward with that program.

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Timothy W. Trost, Chimerix, Inc. - Senior VP, CFO, Corporate Secretary & Office of CEO [26]

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Yes. Ed, I mean, it's effectively been paused as of this time but, I mean, notwithstanding that there are certainly ideas of additional things we could do.

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Operator [27]

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Our next call, from Jessica Fye from JPMorgan.

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Yuko Oku, JP Morgan Chase & Co, Research Division - Analyst [28]

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This is Yuko on the call for Jessica. Could you comment on your confidence in procuring a smallpox contract this year prior to filing an approval?

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Timothy W. Trost, Chimerix, Inc. - Senior VP, CFO, Corporate Secretary & Office of CEO [29]

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Well, no. I mean that's an unknown. I mean I think historically there's always been the theoretical prospect of a preapproval BARDA contract, but work with animals is ongoing. And the work in animals carries, as mentioned earlier, a reasonably lengthy time frame from data from the pivotal trial to the audit of that data; to the final, final, final report. So I don't know is the short answer.

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Operator [30]

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Our next question is from Phil Nadeau from Cowen and Company.

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Philip M. Nadeau, Cowen and Company, LLC, Research Division - MD and Senior Research Analyst [31]

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First one, on the AdAPT trial. You mentioned a number of factors that you think may be contributing to the slower-than-expected enrollment. What about the enrollment criteria themselves? That was one thing you didn't mention. Are you finding the same proportion of patients meeting the screening criteria that you expected? Appreciating that the overall rate is lower, are the patients having the same characteristics that you thought when they do present?

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William Garrett Nichols, Chimerix, Inc. - Chief Medical Officer & Office of CEO [32]

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That's a good question. So we -- as you'll recall, we're targeting patients that are at high risk for adenovirus infection after pediatric allo stem cell transplant. The initial enrollment criteria for that study was thus T cell depleted transplants. And those could be patients who were either T cell depleted ex vivo using cell-sorting machines or patients who received T cell depleted transplants due to the use of sero therapy like Campath or ATG. As the trial has enrolled, we expanded those criteria to include other high-risk patients, including those who received cord blood and haploidentical transplants. Those changes to the protocol are in process, and we expect them to be able to increase the pool of pediatric patients who are eligible for the study.

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Philip M. Nadeau, Cowen and Company, LLC, Research Division - MD and Senior Research Analyst [33]

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Got it, okay. That makes sense. And then on the IV brinci, you're saying some of the same reasons for the delay there, like regulatory approvals. Is IV brinci happening in the same sites, same countries as AdAPT? Or are you having the same issues, just with a whole different set of institutions and territories?

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William Garrett Nichols, Chimerix, Inc. - Chief Medical Officer & Office of CEO [34]

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So there are overlapping sites and centers, although generally pediatric transplant centers and adult transplant centers are separate institutions. So they're separate contracts and we kind of have to start at square one with each one of these sites. These are large academic centers often with very bureaucratic systems that include a scientific review, an operational review, a financial review prior even to IRB reviews and final contract. So it's just been a long process for us.

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Philip M. Nadeau, Cowen and Company, LLC, Research Division - MD and Senior Research Analyst [35]

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Got it, okay. And then Tim, one last one for you on the potential for a BARDA contract. You mentioned negotiations. What exactly is going on with BARDA? Are there ongoing discussions? And are there any milestones or events that those of us external can look for?

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Timothy W. Trost, Chimerix, Inc. - Senior VP, CFO, Corporate Secretary & Office of CEO [36]

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Well, as far as discussions, I mean, there always are ongoing discussions with BARDA. We continue to work very actively with them on our development contract. Regarding the work that's going on right now that's important, I mean you heard about the mouse trial from Garrett. So we're all anxiously awaiting the data from that, and then we'll see what that says and go from there.

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Operator [37]

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Our next question is from Stephen Willey from Stifel.

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Stephen Douglas Willey, Stifel, Nicolaus & Company, Incorporated, Research Division - Director [38]

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Can you just remind how many patients you're targeting again for enrollment into the IV brincidofovir study, so 210 and 211? And I think you also suggested that there might be an opportunity to get an early read on multi-viral efficacy. Can you also just remind us, I guess just given the number of patients that you're going to disclose here, what proportion of those do you think you might actually get a multi-viral read in?

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William Garrett Nichols, Chimerix, Inc. - Chief Medical Officer & Office of CEO [39]

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Sure. So 210 and 211 are dose-escalation studies. Each one of the dose levels is 10 patients randomized 4 to 1 to IV brincidofovir or standard of care. And we could enroll anywhere from 1 to 3 cohorts in each one of those studies, and so up to 30 patients in each study in order to give us information with regards to PK/PD. And as far as the -- as far as reactivation rates for other viruses, as you know, for CMV seropositive patients, approximately 50% of those patients would reactivate in the time period that they would be receiving treatment for adenovirus. So that just kind of gives you a general rate for that. BK virus infection is less common. Probably no more than 1/3 of the patients would reactivate BK virus in the plasma and give us a read, as far as that's concerned.

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Operator [40]

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Thank you. At this time, I am showing no further questions. I would like to turn the call back over to Garrett for closing remarks.

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William Garrett Nichols, Chimerix, Inc. - Chief Medical Officer & Office of CEO [41]

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Well, we thank everyone for your time this morning, and we look forward to updating you in the coming months. Thanks for the call.

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Operator [42]

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Ladies and gentlemen, thank you for your participation in today's conference. This concludes the program. You may now disconnect.