Chimerix Announces Fourth Quarter and Full Year 2014 Financial Results
Recent Company Highlights
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Phase 3 SUPPRESS Enrollment is Expected to be Completed in Summer 2015 and Data are Anticipated in Early 2016
The SUPPRESS trial of brincidofovir for the prevention of cytomegalovirus (CMV) in hematopoietic cell transplant recipients (HCT, also known as a bone marrow transplant), is over 80 percent enrolled, with full enrollment expected to be completed in the summer of 2015. Brincidofovir, if approved, would be the first and only drug for the prevention of CMV in HCT recipients. Patients undergoing HCT who have antibody evidence of prior CMV infection continue to have a higher mortality rate during the first year after transplant than patients who do not have evidence of prior CMV infection, an indicator of the inadequacy of the current approaches to CMV management and the need for a safe and effective agent that could prevent CMV infection. Secondary endpoints of SUPPRESS include the rates of clinical events caused by other dsDNA viruses such as AdV, BKV, and EBV, overall mortality, and multiple measures of healthcare utilization.
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Interim Data from the Phase 3 AdVise Trial of Brincidofovir For Adenovirus Infection Suggests Improved Survival Compared to Historical Reports
The Phase 3 AdVise trial began enrolling patients inMarch 2014 . Patients with localized or disseminated adenovirus infection receive brincidofovir for 12 weeks and are followed for a minimum of 12 weeks after they complete treatment. Preliminary results showed a mortality rate of 37% (20 of 54) amongst allogeneic HCT recipients with disseminated disease; this mortality rate has clinical implications for the potential utility of brincidofovir in these patients, given published mortality rates of up to 80 percent for allogeneic transplant recipients with disseminated adenovirus disease. Notably, the allogeneic transplant recipients who began brincidofovir with localized or asymptomatic adenovirus infection had an observed mortality rate of 11 percent (2 of 18 subjects). Median observation in this analysis was 10 weeks following the first dose (range: 1 to 34 weeks). In addition to these important clinical outcomes, a median decrease of greater than 99 percent in the amount of AdV in the blood (or decreased to undetectable levels) was observed in the majority of patients. Over half of the patients enrolled in AdVise had more than one dsDNA viral infection at the time of enrollment. These results were consistent with the results observed in the first 45 subjects in the AdVise trial as presented at theOctober 2014 annualInfectious Disease Society of America meeting (IDWeek®).
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Patent for Brincidofovir Composition of Matter Extends Exclusivity to 2034
The United States Patent and Trademark Office issued a patent toChimerix inFebruary 2015 covering a method of synthesis and the commercial morphic form of brincidofovir. With the addition of this most recent patent, composition of matter coverage for brincidofovir in the U.S. is extended into 2034.
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Phase 3 Clinical Trial of Brincidofovir in Kidney Transplant Recipients is Expected to Begin in Second Half 2015
The proposed Phase 3 trial is designed to assess brincidofovir compared to valganciclovir in high-risk kidney transplant recipients. The primary objective of the trial is to demonstrate the impact of both antivirals on the rate of CMV infection. In addition, a trial of brincidofovir in this population would provide an opportunity to evaluate brincidofovir's activity against BK virus, a polyoma virus that is a leading cause of kidney injury in this patient population. Preservation of kidney function is closely correlated with long-term graft survival; although there have been improvements over the last two decades, 10-year kidney graft survival remains less than 50 percent.
Fourth Quarter 2014 Financial Results
Revenues for the fourth quarter of 2014 increased to
Research and development expenses were
Loss from operations was
Interest expense was
Full Year 2014 Financial Results
Revenues for 2014 decreased to
Research and development expenses were
Loss from operations was
Interest expense was
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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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| CONSOLIDATED BALANCE SHEETS | ||
| (in thousands, except share and per share data) | ||
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| 2014 | 2013 | |
| ASSETS | ||
| Current assets: | ||
| Cash and cash equivalents | $ 128,462 | $ 109,976 |
| Short-term investments, available-for-sale | 106,114 | — |
| Accounts receivable | 106 | 248 |
| Prepaid expenses and other current assets | 2,775 | 2,785 |
| Total current assets | 237,457 | 113,009 |
| Long-term investments | 52,973 | — |
| Property and equipment, net of accumulated depreciation | 1,310 | 338 |
| Other long-term assets | 138 | 40 |
| Total assets | $ 291,878 | $ 113,387 |
| LIABILITIES AND STOCKHOLDERS' EQUITY | ||
| Current liabilities: | ||
| Accounts payable | $ 5,938 | $ 2,214 |
| Accrued liabilities | 6,833 | 2,420 |
| Loan payable, net current portion | 4,296 | 5,573 |
| Total current liabilities | 17,067 | 10,207 |
| Other long-term liabilities | 175 | 347 |
| Loan payable, net less current portion | — | 4294 |
| Total liabilities | 17,242 | 14,848 |
| Commitments and contingencies | — | — |
| Stockholders' equity: | ||
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Preferred stock, |
— | — |
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Common stock, |
41 | 26 |
| Additional paid-in capital | 496,602 | 261,243 |
| Accumulated other comprehensive gain | 35 | — |
| Accumulated deficit | (222,042) | (162,730) |
| Total stockholders' equity | 274,636 | 98,539 |
| Total liabilities and stockholders' equity | $ 291,878 | $ 113,387 |
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| CONSOLIDATED STATEMENTS OF OPERATIONS AND COMPREHENSIVE LOSS | ||||
| (in thousands, except share and per share data) | ||||
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Three Months Ended |
Year Ended |
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| 2014 | 2013 | 2014 | 2013 | |
| Revenues: | ||||
| Contract revenue | $ 1,156 | $ 879 | $ 4,040 | $ 4,370 |
| Total revenues | 1,156 | 879 | 4,040 | 4,370 |
| Operating expenses: | ||||
| Research and development | 15,667 | 6,284 | 45,379 | 24,662 |
| General and administrative | 5,715 | 2,574 | 17,527 | 8,327 |
| Total operating expenses | 21,382 | 8,858 | 62,906 | 32,989 |
| Loss from operations | (20,226) | (7,979) | (58,866) | (28,619) |
| Other expenses: | ||||
| Interest expense, net | (20) | (195) | (445) | (1,232) |
| Fair value adjustments to preferred stock warrant liability | — | — | — | (6,590) |
| Loss on disposition of assets | (1) | — | (1) | (4) |
| Net loss | (20,247) | (8,174) | (59,312) | (36,445) |
| Other comprehensive loss: | ||||
| Unrealized (loss) gain on investments, net | (1) | (1) | 35 | 2 |
| Comprehensive loss | $ (20,248) | $ (8,175) | $ (59,277) | $ (36,443) |
| Net loss | (20,247) | (8,174) | (59,312) | (36,445) |
| Accretion of redeemable convertible preferred stock | — | — | — | (34,108) |
| Net loss attributable to common stockholders | $ (20,247) | $ (8,174) | $ (59,312) | $ (70,533) |
| Per share information: | ||||
| Net loss, basic and diluted | $ (0.52) | $ (0.31) | $ (1.80) | $ (3.65) |
| Weighted-average shares outstanding, basic and diluted | 39,128,297 | 26,416,787 | 33,003,714 | 19,307,422 |
CONTACT:Source:Joseph T. Schepers Executive Director, Investor Relations and Corporate Communications ir@chimerix.com 919-287-4125
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