SECURITIES AND EXCHANGE COMMISSION
Washington, D.C. 20549
Pursuant to Section 13 or 15(d)
of the Securities Exchange Act of 1934
August 8, 2018
Date of Report (Date of earliest event reported)
(Exact name of registrant as specified in its charter)
(State or other jurisdiction
(Commission File Number)
(IRS Employer Identification No.)
2505 Meridian Parkway, Suite 100
(Address of principal executive offices)
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)
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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 August 8, 2018, we announced our financial results for the second quarter ended June 30, 2018 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.
Financial Statements and Exhibits.
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.
Dated: August 8, 2018
/s/ Timothy W. Trost
Timothy W. Trost
Senior Vice President, Chief Financial Officer and Corporate Secretary
Chimerix Announces Second Quarter 2018 Financial Results
- Conference Call at 8:30 a.m. ET Today -
DURHAM, N.C., August 8, 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 second quarter ended June 30, 2018.
“Throughout the second quarter of 2018, we continued to make steady progress advancing our novel antivirals across a number of important clinical studies. Our lead product candidate, brincidofovir (BCV), is moving forward as a treatment for life-threatening adenovirus infection in the AdAPT study, which we expect to be fully enrolled in 2019. We are opening sites for our Phase 2 studies for intravenous (IV) BCV in the United States and Europe. In addition to brincidofovir, we are advancing CMX521 in the clinic for the treatment and prevention of norovirus supported by results from a single dose study in healthy subjects and strong preclinical data,” said M. Michelle Berrey, MD, MPH, President and Chief Executive Officer of Chimerix.
Addressed Congressional Subcommittee in Support of Reauthorization of the Pandemic and All-Hazards Preparedness Act (PAHPA)
In June, Dr. Berrey, delivered remarks before the House Committee on Energy and Commerce Subcommittee on Health at a hearing titled “Examining the Reauthorization of the Pandemic and All-Hazards Preparedness Act” in Washington, D.C. The purpose of the hearing was to reauthorize certain programs under the Pandemic and All-Hazards Preparedness Act (PAHPA), which originally passed in 2006 and seeks to improve the United States’ public health and medical preparedness and response capabilities for emergencies, whether deliberate, accidental or natural.
The AdAPT study (Adenovirus after Allogeneic Pediatric Transplantation) is open for enrollment in the United States (US), the United Kingdom (UK), and Europe. Four of nine planned countries are currently undergoing regulatory or central ethics review; additional sites in the US, UK and Europe are also in the process of opening for enrollment.
IV BCV Phase 2 Studies Initiating in the US, UK and Europe
The Company is opening sites in the US, UK and Europe for enrollment in IV BCV Phase 2 studies in adult hematopoietic cell transplant recipients with adenovirus. Chimerix anticipates interim data in the second half of 2018.
Received Orphan Drug Designation for Brincidofovir for the Treatment of Smallpox
In June, Chimerix announced that the US Food and Drug Administration (FDA) granted Orphan Drug Designation for brincidofovir for the treatment of smallpox. The Orphan Drug Designation program provides orphan status to drugs and biologics which are defined as those intended for the safe and effective treatment, diagnosis or prevention of rare diseases and disorders that affect fewer than 200,000
people in the United States. Orphan Drug Designation provides manufacturers with many benefits, including a waiver of the FDA Prescription Drug User Fee Act.
Chimerix intends to submit marketing applications for smallpox following the completion of the rabbit and mouse efficacy studies.
Presented Preclinical CMX521 Data at 31st International Conference on Antiviral Research (ICAR)
In June, Chimerix presented results from preclinical studies supporting clinical evaluation of CMX521, the first clinical-stage direct-acting antiviral specifically for the treatment and prevention of norovirus. CMX521 showed activity in vitro against all strains of norovirus tested, suggesting broad efficacy against human noroviruses and supporting the ongoing Phase 1 study. These data were presented in oral and poster presentations at the 31st International Conference on Antiviral Research (ICAR) in Porto, Portugal.
In late 2017, Chimerix initiated a first-time-in-human Phase 1 study of CMX521 to evaluate the pharmacokinetics, safety and tolerability of CMX521 in healthy adult subjects. The first presentation of clinical data on CMX521 will be in September at the European Society for Clinical Virology in Athens, Greece.
Second Quarter 2018 Financial Results
Chimerix reported a net loss of $18.6 million, or $0.39 per basic and diluted share, for the second quarter of 2018. During the same period in 2017, Chimerix recorded a net loss of $16.7 million, or $0.36 per basic and diluted share.
Revenues for the second quarter of 2018 increased to $1.2 million, compared to $0.7 million for the same period in 2017.
Research and development expenses increased to $13.7 million for the second quarter of 2018, compared to $11.6 million for the same period in 2017.
General and administrative expenses increased to $6.7 million for the second quarter of 2018, compared to $6.3 million for the same period in 2017.
Loss from operations was $19.2 million for the second quarter of 2018, compared to a loss from operations of $17.2 million for the same period in 2017.
Chimerix's balance sheet at June 30, 2018 included $195.7 million of capital available to fund operations, no debt, and approximately 47.9 million outstanding shares of common stock.
Today's Conference Call and Webcast
Chimerix will host a conference call and live audio webcast to discuss second quarter 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 2976768.
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.
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 and Orphan Medicinal Product Designation from the European Commission for adenovirus, cytomegalovirus, and smallpox.
CMX521 is a nucleoside antiviral identified from the Chimerix Chemical Library as a potential treatment and/or prevention for norovirus, the most common cause of acute gastroenteritis worldwide. An ongoing Phase 1 study is evaluating the pharmacokinetics, safety and tolerability of CMX521.
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 CMX521, the first clinical-stage direct-acting antiviral for the treatment and prevention of norovirus. For further information, please visit Chimerix's website, www.chimerix.com.
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 our current or future clinical trials of brincidofovir may not be successful, 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 Quarterly Report on Form 10-Q 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.
Stern Investor Relations
CONSOLIDATED BALANCE SHEETS
(in thousands, except share and per share data)
June 30, 2018
December 31, 2017
Cash and cash equivalents
Short-term investments, available-for-sale
Prepaid expenses and other current assets
Total current assets
Property and equipment, net of accumulated depreciation
Other long-term assets
LIABILITIES AND STOCKHOLDERS' EQUITY
Total current liabilities
Preferred stock, $0.001 par value, 10,000,000 shares authorized at June 30, 2018 and December 31, 2017; no shares issued and outstanding as of June 30, 2018 and December 31, 2017
Common stock, $0.001 par value, 200,000,000 shares authorized at June 30, 2018 and December 31, 2017; 47,855,025 and 47,505,532 shares issued and outstanding as of June 30, 2018 and December 31, 2017, respectively
Additional paid-in capital
Accumulated other comprehensive loss, net
Total stockholders’ equity
Total liabilities and stockholders’ equity
CONSOLIDATED STATEMENTS OF OPERATIONS AND COMPREHENSIVE LOSS
(in thousands, except share and per share data)
Three Months Ended June 30,
Years Ended December 31,
Research and development
General and administrative
Total operating expenses
Loss from operations
Other (expense) income:
Unrealized loss on equity investment
Other comprehensive loss:
Unrealized gain (loss) on investments, net
Per share information:
Net loss, basic and diluted
Weighted-average shares outstanding, basic and diluted