Document


UNITED STATES
 
SECURITIES AND EXCHANGE COMMISSION
 
Washington, D.C. 20549
 
FORM 8-K
 
CURRENT REPORT
 
Pursuant to Section 13 or 15(d)
of the Securities Exchange Act of 1934
 
March 1, 2018
Date of Report (Date of earliest event reported)
 
Chimerix, Inc.
(Exact name of registrant as specified in its charter)
 
Delaware
 
001-35867
 
33-0903395
(State or other jurisdiction
 
(Commission File Number)
 
(IRS Employer Identification No.)
of incorporation)
 
 
 
 
 
2505 Meridian Parkway, Suite 100
Durham, NC
 
27713
(Address of principal executive offices)
 
(Zip Code)
 
Registrant’s telephone number, including area code: (919) 806-1074
 
Check the appropriate box below if the Form 8-K filing is intended to simultaneously satisfy the filing obligations of the registrant under any of the following provisions: 
 
¨
Written communications pursuant to Rule 425 under the Securities Act (17 CFR 230.425) 
 
¨
Soliciting material pursuant to Rule 14a-12 under the Exchange Act (17 CFR 240.14a-12)
 
¨
Pre-commencement communications pursuant to Rule 14d-2(b) under the Exchange Act (17 CFR 240.14d-2(b))
 
¨
Pre-commencement communications pursuant to Rule 13e-4(c) under the Exchange Act (17 CFR 240.13e-4(c))
 
Indicate by check mark whether the registrant is an emerging growth company as defined in Rule 405 of the Securities Act of 1933 (§230.405 of this chapter) or Rule 12b-2 of the Securities Exchange Act of 1934 (§240.12b-2 of this chapter).
Emerging growth company ¨
If an emerging growth company, indicate by check mark if the registrant has elected not to use the extended transition period for complying with any new or revised financial accounting standards provided pursuant to Section 13(a) of the Exchange Act. ¨







Item 2.02 Results of Operations and Financial Condition.
 
On March 1, 2018, we announced our financial results for the fourth quarter and full year ended December 31, 2017 in the press release attached hereto as Exhibit 99.1 and incorporated herein by reference.
 
The information in this Item 2.02 and the attached Exhibit 99.1 is being furnished and shall not be deemed “filed” for the purposes of Section 18 of the Securities and Exchange Act of 1934, as amended, or otherwise subject to the liabilities of that Section. The information in this Item 2.02 and the attached Exhibit 99.1 shall not be incorporated by reference into any registration statement or other document pursuant to the Securities Act of 1933, as amended.
 
Item 9.01
Financial Statements and Exhibits.
 
(d)
Exhibits
Exhibit No.
 
Description
99.1
 
 






SIGNATURES
 
Pursuant to the requirements of the Securities Exchange Act of 1934, the Registrant has duly caused this report to be signed on its behalf by the undersigned hereunto duly authorized.
 

 
Chimerix, Inc.
 
 
 
Dated: March 1, 2018
 
 
 
 
By:
/s/ Timothy W. Trost
 
 
 
Timothy W. Trost
 
 
 
Senior Vice President, Chief Financial Officer and Corporate Secretary

 
 




Exhibit
http://api.tenkwizard.com/cgi/image?quest=1&rid=23&ipage=12096574&doc=3

Chimerix Announces Fourth Quarter and Full Year 2017 Financial Results
            
- AdVance Data to be Presented at EBMT Annual Meeting -

- Oral and IV BCV Programs Remain on Track -

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

DURHAM, N.C., March 1, 2018 -- 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, 2017.

“We are pleased to announce that we have initiated AdAPT in both the US and EU, a study designed to provide comparative data on brincidofovir in patients with life-threatening adenovirus infection. As potentially the first treatment for adenovirus, oral brincidofovir could allow us to establish initial revenues as the IV brincidofovir program progresses,” said M. Michelle Berrey, MD, MPH, President and Chief Executive Officer of Chimerix.

“Beyond brincidofovir, we are pleased with the progress of our ongoing first-time-in-human study for CMX521. As a proprietary nucleoside analog identified from our chemical library, CMX521 is the first antiviral specific for norovirus, a serious infection for which there is no currently approved treatment.”

Program Updates

AdAPT: Short-Course Oral Brincidofovir for AdV Infection in Pediatric HCT Recipients

This study is targeting enrollment of 141 pediatric allogeneic hematopoietic cell transplant (HCT) recipients with confirmed clinically significant adenovirus (AdV) infection. Patients are randomized 2:1 to receive short-course oral brincidofovir (BCV) or the local standard-of-care (SOC) at approximately 30 sites across Europe and the United States.

The primary endpoint of the study is the average AdV viral burden (as measured by AdV levels in blood) over 16 weeks in subjects treated with short-course oral BCV versus those who receive local SOC. The study is 90% powered to show the superiority of reduced AdV viral burden in BCV-treated patients compared to SOC. The study will also evaluate the correlation of AdV viral burden (and its clearance) with clinical outcomes, including survival. Enrollment is estimated to complete in 2019.

Later this month, at the annual meeting of the European Society of Bone and Marrow Transplantation (EBMT), the Company will present final data on AdVance, a study of the incidence of AdV infection in HCT recipients and outcomes associated with the current SOC across Europe. Data from AdVance are expected to highlight the current gaps in treatment with SOC and the need for new therapeutic options.

Short-Course Oral BCV for Smallpox

Based on advice from the European Medicines Agency (EMA), the Company is preparing a Marketing Authorization Application (MAA) for submission to EMA in 2019. Chimerix also plans to submit a New Drug Application (NDA) for smallpox contingent upon the results of animal efficacy studies planned for 2018, including an adjunct study in the rabbitpox model.




IV Brincidofovir

Chimerix has successfully completed a multiple ascending dose (MAD) study of IV BCV in healthy subjects and is initiating Phase 2 studies in adult HCT recipients with AdV infection with data expected in the second half of 2018. The MAD study evaluated the safety, tolerability and pharmacokinetics of IV BCV 10 mg twice weekly and IV BCV 20 mg once weekly in healthy subjects for two to four weeks. IV BCV was well-tolerated at all dose levels, with no dose-limiting clinical adverse events. Importantly, there was no diarrhea reported for IV BCV 10 mg twice weekly, a dose that provides drug levels in plasma equivalent to oral BCV 100 mg, which demonstrated antiviral activity in previous late-stage clinical studies. Non-clinically-relevant elevations in serum transaminases were noted as seen in previous studies of oral BCV.

CMX521 for Norovirus Now in Phase 1

In late 2017, Chimerix initiated a first-time-in-human study of CMX521, a nucleoside analog from the Chimerix Chemical Library. CMX521 is the first antiviral specific for the treatment and/or prevention for norovirus. The Phase 1 study is evaluating the pharmacokinetics, safety and tolerability of CMX521 in up to 50 healthy adult subjects. The study also includes the collection of gut biopsy specimens, which will allow determination of active drug concentrations in the target gut tissue. Study results are expected in mid-2018.

Fourth Quarter 2017 Financial Results

Chimerix reported a net loss of $19.2 million, or $0.41 per basic and diluted share, for the fourth quarter of 2017. During the same period in 2016, Chimerix recorded a net loss of $15.0 million, or $0.32 per basic and diluted share. 

Revenues for the fourth quarter of 2017 decreased to $1.8 million, compared to $2.0 million for the same period in 2016.

Research and development expenses were $12.9 million for the three month period ended December 31, 2017, and $11.7 million for the same period in 2016

General and administrative expenses increased to $7.6 million for the fourth quarter of 2017, compared to $5.6 million for the same period in 2016

Loss from operations was $18.7 million for the fourth quarter of 2017, compared to a loss from operations of $15.4 million for the same period in 2016

Chimerix's balance sheet at December 31, 2017 included $227.9 million of capital available to fund operations, no debt, and approximately 47.5 million outstanding shares of common stock.

Full Year 2017 Financial Results

Chimerix reported a net loss of $71.0 million, or $1.51 per basic and diluted share, for the year ended December 31, 2017. For the year ended December 31, 2016, Chimerix recorded a net loss of $76.4 million, or $1.65 per basic and diluted share.

Revenues for 2017 decreased to $4.5 million, compared to $5.7 million in 2016.

Research and development expenses were $49.4 million for the year ended December 31, 2017, compared to $58.6 million for the year ended December 31, 2016.




General and administrative expenses increased to $27.1 million for the year ended December 31, 2017, compared to $25.0 million for the year ended December 31, 2016

Loss from operations was $72.1 million for the year ended December 31, 2017, compared to a loss from operations of $78.0 million for the year ended December 31, 2016

Net interest income was $2.3 million for the year ended December 31, 2017, compared to net interest income of $1.6 million for the year ended December 31, 2016.

Today's Conference Call and Webcast

Chimerix will host a conference call and live audio webcast to discuss fourth quarter and full year 2017 financial results and provide a business update today at 8:30 a.m. ET. To access the live conference call, please dial 877-354-4056 (domestic) or 678-809-1043 (international) at least five minutes prior to the start time and refer to conference ID 1153769.

A live audio webcast of the call will also be available on the Investors section of Chimerix's website, www.chimerix.com. An archived webcast will be available on the Chimerix website approximately two hours after the event.

About Brincidofovir

Chimerix's lead product candidate, brincidofovir, is a nucleotide analog that has antiviral activity against all five families of DNA viruses that affect humans, including the herpesviruses and adenoviruses. Brincidofovir has a high barrier to resistance, no myelosuppression and a low risk of nephrotoxicity. Brincidofovir has received Fast Track designation from the FDA for adenovirus, cytomegalovirus (CMV) and smallpox. Brincidofovir has also received Orphan Medicinal Product Designation from the European Commission for adenovirus, CMV, and smallpox. 

About Chimerix

Chimerix is a biopharmaceutical company dedicated to discovering, developing and commercializing medicines that improve outcomes for immunocompromised patients. Chimerix's proprietary lipid conjugate technology and Compound Library have produced brincidofovir (BCV, CMX001); CMX157, which was licensed to ContraVir Pharmaceuticals; and a new clinical candidate, CMX521, the first direct-acting antiviral specifically for the treatment and prevention of norovirus to enter clinical testing. For further information, please visit Chimerix's website, www.chimerix.com.

Forward-Looking Statements

This press release includes forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995 that are subject to risks, uncertainties and other factors, including the possibility that there may not be a viable continued development path for brincidofovir, that 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 for regulatory approval for brincidofovir with other regulatory authorities. Similar risks and uncertainties apply to the Company’s development of CMX521.These risks, uncertainties and other factors could cause actual results to differ materially from those expressed or implied by such forward-looking statements. Risks are described more fully in the Company's filings with the Securities and Exchange Commission, including without limitation the Company's most recent Annual Report on Form 10-K and other documents subsequently filed with or furnished to the Securities and Exchange Commission. All forward-looking statements contained in this press release speak only as of the date on which they were made. The



Company undertakes no obligation to update such statements to reflect events that occur or circumstances that exist after the date on which they were made.


CONTACT:
Investor Relations:
Michelle LaSpaluto
(919) 972-7115
ir@chimerix.com
or
Will O’Connor
Stern Investor Relations
Will@sternir.com
212-362-1200

Media:
Becky Vonsiatsky
W2O Group
bvonsiatsky@w2ogroup.com
413-478-2003






CHIMERIX, INC.
CONSOLIDATED BALANCE SHEETS
(in thousands, except share and per share data)
 

 
December 31,
 
2017
 
2016
ASSETS
 

 
 

Current assets:
 

 
 

     Cash and cash equivalents
$
18,548

 
$
51,463

     Short-term investments, available-for-sale
132,972

 
180,558

     Accounts receivable
1,682

 
1,599

     Prepaid expenses and other current assets
3,331

 
2,845

          Total current assets
156,533

 
236,465

Long-term investments
76,731

 
47,407

Property and equipment, net of accumulated depreciation
1,894

 
2,843

Other long-term assets
72

 
55

               Total assets
$
235,230

 
$
286,770

LIABILITIES AND STOCKHOLDERS' EQUITY
 

 
 

Current liabilities:
 

 
 

     Accounts payable
$
3,812

 
$
3,890

     Accrued liabilities
9,384

 
6,215

          Total current liabilities
13,196

 
10,105

Lease-related obligations
224

 
441

          Total liabilities
13,420

 
10,546

Stockholders’ equity:
 

 
 

Preferred stock, $0.001 par value, 10,000,000 shares authorized at December 31, 2017 and 2016; no shares issued and outstanding as of December 31, 2017 and 2016

 

Common stock, $0.001 par value; 200,000,000 shares authorized at December 31, 2017 and 2016; 47,505,532 and 46,522,475 shares issued and outstanding at December 31, 2017 and 2016, respectively
47

 
46

     Additional paid-in capital
709,514

 
692,422

     Accumulated other comprehensive loss, net
(963
)
 
(440
)
     Accumulated deficit
(486,788
)
 
(415,804
)
          Total stockholders’ equity
221,810

 
276,224

               Total liabilities and stockholders’ equity
$
235,230

 
$
286,770





CHIMERIX, INC.
CONSOLIDATED STATEMENTS OF OPERATIONS AND COMPREHENSIVE LOSS 
(in thousands, except share and per share data)

 
Three Months Ended December 31,
 
Years Ended December 31,
 
2017
 
2016
 
2017
 
2016
Contract revenue
$
1,844

 
$
1,980

 
$
4,494

 
$
5,702

Operating expenses:
 
 
 
 
 

 
 

     Research and development
12,913

 
11,705

 
49,448

 
58,647

     General and administrative
7,618

 
5,648

 
27,148

 
25,007

          Total operating expenses
20,531

 
17,353

 
76,596

 
83,654

               Loss from operations
(18,687
)
 
(15,373
)
 
(72,102
)
 
(77,952
)
Other (expense) income:
 
 
 
 
 

 
 

     Other-than-temporary impairment of investment
(1,160
)
 

 
(1,160
)
 

     Interest income
609

 
416

 
2,278

 
1,562

               Net loss
(19,238
)
 
(14,957
)
 
(70,984
)
 
(76,390
)
Other comprehensive loss:
 
 
 
 
 

 
 

     Unrealized gain (loss) on investments, net
518

 
(74
)
 
(523
)
 
324

          Comprehensive loss
$
(18,720
)
 
$
(15,031
)
 
$
(71,507
)
 
$
(76,066
)
Per share information:
 
 
 
 
 

 
 

     Net loss, basic and diluted
$
(0.41
)
 
$
(0.32
)
 
$
(1.51
)
 
$
(1.65
)
      Weighted-average shares outstanding, basic and diluted
47,341,271

 
46,431,809

 
46,963,430

 
46,267,064