Chimerix Announces First Quarter 2014 Financial Results
Recent Company Highlights
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Brincidofovir Phase 3 SUPPRESS Trial
The Company is currently enrolling patients in the Phase 3 SUPPRESS trial of brincidofovir for the prevention of cytomegalovirus (CMV) in recipients of hematopoietic cell transplants (HCT), also known as bone marrow transplantation. CMV, a DNA virus, remains the most common cause of fatal infections in HCT recipients. Enrollment of the planned 450 subjects is on track to deliver pivotal data in mid-2015.
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Initiation of Brincidofovir Pilot Trial for the Treatment of Adenovirus Infection
InMarch 2014 ,Chimerix , in collaboration with theU.S. Food and Drug Administration (FDA), initiated the pilot portion of a Phase 3 protocol to evaluate brincidofovir for the treatment of adenovirus infections in immunocompromised pediatric and adult patients. The final study design for the Phase 3 study is anticipated in 2H2014, and is likely to include evaluation of two durations of brincidofovir therapy for the treatment of disseminated adenovirus infection. The Company is currently in discussions with theFDA to finalize the design of a pivotal trial that is intended to support approval of brincidofovir for the treatment of adenovirus infection.
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Publication of Clinical Data Supporting Brincidofovir's Activity in Adenovirus Infection and its Favorable Safety and Tolerability Profile
InApril 2014 , at theEuropean Society for Blood and Marrow Transplantation (EBMT) meeting, a summary of brincidofovir safety data from two placebo-controlled studies and an expanded access trial of brincidofovir were presented. Brincidofovir therapy showed no evidence of negative effects on white blood cell production and no evidence of negative effects on the new bone marrow graft. The hematologic safety profile has allowed brincidofovir to begin dosing in the first days following HCT in the Phase 3 SUPPRESS trial, to evaluate potential protection against viral infections that can occur as early as the first week following transplant.
InFebruary 2014 , at the Blood and Marrow Transplant (BMT) Tandem meeting the safety profile of brincidofovir in over 100 high-risk pediatric patients, including children less than two years of age was presented. The Company presented data on adenovirus infection and the potential for brincidofovir in these patients. These oral presentations suggested that brincidofovir may be well tolerated in highly immunocompromised pediatric patients and may have antiviral activity against adenovirus, a DNA virus with a high mortality rate that has no available therapy.
First Quarter 2014 Financial Results
Revenues for the first quarter of 2014 decreased to
Research and development expenses were
Loss from operations was
Interest expense was
For the first quarter of 2014, there were no fair value of warrant charges as all of the outstanding preferred warrants converted to common stock warrants upon the completion of the IPO in April 2013. For the first quarter of 2013, the company recorded a
Today's Conference Call and Webcast
A live audio webcast of the call will also be available on the Investors section of
About Brincidofovir (CMX001)
About Cytomegalovirus (CMV)
CMV is a member of the herpes virus family and remains the most common cause of fatal infections in HCT recipients. Two-thirds of adults have been exposed to CMV, generally in childhood, with lifelong viral latency established following the initial infection. In immunocompromised individuals such as transplant recipients, CMV often reactivates during the post-transplant period when the immune system is weak. CMV itself is immunosuppressive and reactivation of the virus can predispose a patient to other opportunistic infections. No therapies are approved for the prevention of CMV in HCT recipients.
About Adenovirus (AdV)
AdV causes upper respiratory infections including the common cold in individuals with intact immune systems, but is often rapidly fatal in patients with compromised immune responses. AdV is most common during the post-transplant period when the immune system is weak. No therapies are approved for the treatment of AdV.
About
Forward-Looking Statements
Statements contained in this press release regarding matters that are not historical facts are "forward-looking statements" within the meaning of the Private Securities Litigation Reform Act of 1995. Because such statements are subject to risks and uncertainties, actual results may differ materially from those expressed or implied by such forward-looking statements. Risks are described more fully in
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BALANCE SHEETS | ||
(in thousands) | ||
(unaudited) | ||
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Assets | ||
Current assets: | ||
Cash and cash equivalents |
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Short-term investments, available-for-sale | 62,500 | -- |
Accounts receivable | 89 | 248 |
Prepaid and other current assets | 1,691 | 2,765 |
Deferred financing costs, current portion | 20 | 20 |
Total current assets | 101,721 | 113,009 |
Property and equipment, net of accumulated depreciation | 387 | 338 |
Deposits | 32 | 30 |
Deferred financing costs, less current portion | 13 | 10 |
Total assets |
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Liabilities and stockholders' equity | ||
Current liabilities: | ||
Accounts payable |
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Accrued liabilities | 1,894 | 2,420 |
Loan payable, current portion | 5,590 | 5,573 |
Total current liabilities | 9,290 | 10,207 |
Other long-term liabilities | 350 | 347 |
Loan payable, less current portion | 2,889 | 4,294 |
Total liabilities | 12,529 | 14,848 |
Stockholders' equity: | ||
Preferred stock | -- | -- |
Common stock | 27 | 26 |
Additional paid-in capital | 262,739 | 261,243 |
Accumulated other comprehensive loss | (32) | -- |
Accumulated deficit | (173,110) | (162,730) |
Total stockholders' equity | 89,624 | 98,539 |
Total liabilities and stockholders' equity |
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STATEMENTS OF OPERATIONS AND COMPREHENSIVE LOSS | ||
(in thousands, except share and per share data) | ||
(unaudited) | ||
Three Months Ended March 31, | ||
2014 | 2013 | |
Revenues: | ||
Contract revenue |
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Total revenues | 780 | 1,771 |
Operating expenses: | ||
Research and development | 8,292 | 6,783 |
General and administrative | 2,672 | 1,536 |
Loss from operations | (10,184) | (6,548) |
Other expense: | ||
Other expense, net | (196) | (356) |
Fair value adjustments to warrant liability | -- | (2,203) |
Net loss | (10,380) | (9,107) |
Other comprehensive loss: | ||
Unrealized loss on securities available-for-sale | (32) | (1) |
Comprehensive loss | $ (10,412) | $ (9,108) |
Per share information: | ||
Net loss per common share, basic & diluted | $ (0.39) | $ (22.58) |
Weighted-average shares outstanding, basic & diluted | 26,762,264 | 1,534,016 |
CONTACT: CHIMERIX CONTACT:Source:Joseph T. Schepers Executive Director, Investor Relations and Corporate Communications ir@chimerix.com 919-287-4125
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