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Chimerix Inc (CMRX) SEC Filing 10-K Annual report for the fiscal year ending Monday, December 31, 2018

Chimerix Inc

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CIK: 1117480 Ticker: CMRX
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Chimerix Announces Fourth Quarter and Full Year 2018 Financial Results
            
- Reports Positive Preliminary Top-line Data from Second Rabbitpox Study -

- Type C Meeting Requested with FDA - Regarding Virologic Endpoint -

- Conference Call at 8:30 a.m. ET Today -

DURHAM, N.C., March 5, 2019 -- Chimerix (NASDAQ:CMRX), a biopharmaceutical company developing novel antivirals to address unmet medical needs, today reported financial results and provided a corporate update for the fourth quarter and full-year ended December 31, 2018.

“During 2018 and in recent weeks, we made important strides towards advancing our antiviral pipeline across a number of important infectious disease indications. In particular, we were very pleased with the preliminary data from our rabbitpox study, which showed statistically significant survival benefit in brincidofovir (BCV) treated rabbits,” said Garrett Nichols, M.D., M.S., Chief Medical Officer of Chimerix.

“In addition, we continue to advance brincidofovir for the treatment of adenovirus (AdV) in our AdAPT study, with the goal of completing this trial as quickly as possible given the high mortality associated with this disease. We have, however, faced delays in enrollment of the trial, and will provide an update on projected enrollment completion in mid-2019. We have also submitted a request for a Type C meeting with the U.S. Food and Drug Administration (FDA) to discuss adenoviral burden, the primary endpoint for AdAPT, as a potential surrogate marker for mortality,” concluded Dr. Nichols.

Program Updates

BCV for Smallpox

Today, Chimerix reports preliminary top-line results from the in-life portion of our second rabbitpox efficacy study conducted under the FDA Animal Efficacy Rule.

The study was designed to determine the effect of administering BCV to animals at certain times (3, 4, 5 or 6 days) after infection with the rabbitpox virus. Based on these preliminary findings, the study met its primary endpoint. The top-line survival results are as follows:

 
BCV treatment 3 days post-infection
BCV treatment 4 days post-infection
BCV treatment 5 days post-infection
BCV treatment 6 days post-infection
No treatment (placebo)
Overall Survival
29/29 (100%)
26/29 (90%)
20/29 (69%)
20/29 (69%)
8/28
(29%)
P-value vs. Placebo
<0.0001
<0.0001
0.0014
0.0014
-


Data from this study are consistent with those reported from the Company’s first pivotal rabbitpox study, conducted in 2015.  


The following information was filed by Chimerix Inc (CMRX) on Tuesday, March 5, 2019 as an 8K 2.02 statement, which is an earnings press release pertaining to results of operations and financial condition. It may be helpful to assess the quality of management by comparing the information in the press release to the information in the accompanying 10-K Annual Report statement of earnings and operation as management may choose to highlight particular information in the press release.

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Inside Chimerix Inc's 10-K Annual Report:

Financial Statements, Disclosures and Schedules

Inside this 10-K Annual Report

Document And Entity Information
Consolidated Balance Sheets
Consolidated Balance Sheets (Parenthetical)
Consolidated Statements Of Cash Flows
Consolidated Statements Of Operations And Comprehensive Loss
Consolidated Statements Of Stockholders' Equity (Deficit)
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Commitments And Contingencies (Schedule Of Future Minimum Sublease Rental Payments For Operating Leases) (Details) (Details)
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Income Taxes
Income Taxes (Components Of Deferred Tax Assets And Liabilities) (Details)
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Investments (Tables)
Investments - Available For Sale Securities (Details)
Investments - Summary Of Available-For-Sale Securities (Details)
Investments - Summary Of Investments With Unrealized Losses, Aggregated By Investment Type And The Length Of Time (Details)
Property And Equipment
Property And Equipment (Details)
Property And Equipment (Tables)
Selected Quarterly Financial Data (Unaudited)
Selected Quarterly Financial Data (Unaudited) (Details)
Selected Quarterly Financial Data (Unaudited) (Tables)
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Significant Agreements (Details)
Stockholders' Equity (Deficit)
Stockholders' Equity (Deficit) (Assumption Used To Determine The Fair Value Of Options Granted) (Details)
Stockholders' Equity (Deficit) (Narrative) (Details)
Stockholders' Equity (Deficit) (Schedule Of Allocation Of Recognized Period Costs) (Details)
Stockholders' Equity (Deficit) (Schedule Of Other Information Regarding Stock Options) (Details)
Stockholders' Equity (Deficit) (Schedule Of Share-Based Compensation) (Details)
Stockholders' Equity (Deficit) (Schedule Of Share-Based Compensation, Shares Authorized) (Details)
Stockholders' Equity (Deficit) (Schedule Of Shares Reserved For Future Issuance) (Details)
Stockholders' Equity (Deficit) (Summary Of Activity Related To Restricted Stock Units) (Details)
Stockholders' Equity (Deficit) (Summary Of Activity Related To Stock Options) (Details)
Stockholders' Equity (Deficit) (Tables)
Subsequent Events
The Business And Summary Of Significant Accounting Policies
The Business And Summary Of Significant Accounting Policies (Assets And Liabilities Measured At Fair Value On A Recurring Basis) (Details)
The Business And Summary Of Significant Accounting Policies (Narrative) (Details)
The Business And Summary Of Significant Accounting Policies (Policies)
The Business And Summary Of Significant Accounting Policies (Schedule Of Accrued Liabilities) (Details)
The Business And Summary Of Significant Accounting Policies (Schedule Of Prepaid And Other Current Assets) (Details)
The Business And Summary Of Significant Accounting Policies (Tables)
Ticker: CMRX
CIK: 1117480
Form Type: 10-K Annual Report
Accession Number: 0001117480-19-000010
Submitted to the SEC: Tue Mar 05 2019 3:27:16 AM EST
Accepted by the SEC: Tue Mar 05 2019
Period: Monday, December 31, 2018
Industry: Pharmaceutical Preparations

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