Chimerix Announces Second Quarter 2016 Financial Results
- European Commission Granted Orphan Drug Designation for Brincidofovir for the Treatment of Adenovirus -
- Conference Call at
"We believe that the results of our ongoing development program for brincidofovir have demonstrated clear clinical evidence of its potent antiviral activity against three important DNA viruses: smallpox, cytomegalovirus, and adenovirus. We are continuing to increase our understanding of brincidofovir's antiviral potential in each of these areas and are actively pursuing trial
designs that will provide a clear regulatory path forward for brincidofovir," said
"We also remain committed to understanding the potential broad spectrum efficacy of brincidofovir against other viruses, such as BK virus, and will soon be in clinical testing of a promising intravenous formulation that we believe will address the gastrointestinal side effects that affected outcomes in the Phase 3 SUPPRESS trial for prevention of CMV in hematopoietic cell transplant recipients. We are also investigating alternative formulations of brincidofovir for long-term use in the solid organ transplant setting. With the patent life for brincidofovir extending until 2034 and our strong cash position, we believe it is critical to progress
these efforts while continuing to work closely with both
Program Updates:
Brincidofovir for Adenovirus
In May,
Additional 24 week data results from the AdVise study will be presented
"The AdVise study was the largest clinical study ever conducted in patients with serious adenovirus infections, and we are proud to be advancing development in the field as the first company to attempt to treat this life-threatening condition. We see firsthand the clear unmet need in this area from continued
demand of approximately one patient per day for brincidofovir through our Expanded Access trial and Named Patient Program in the
The Company also announced that it is discussing the design of an additional comparative trial in patients with serious adenovirus infection to support a potential regulatory application, with the
"As we look ahead to continued research of brincidofovir in adenovirus, we are pleased that the
Investigation of New Brincidofovir Formulations
Chimerix continues to advance its intravenous (IV) formulation of brincidofovir, and expects to initiate a first-in-human study during the second half of 2016 to establish target exposure levels and safety data.
The Company is also exploring other novel formulations to enable potential longer-term use in the solid organ transplant setting.
Brincidofovir for Smallpox
The development of brincidofovir for smallpox continues, in collaboration with the
Second Quarter 2016 Financial Results
Net loss decreased to
Revenues for the second quarter of 2016 decreased to
Research and development expenses decreased to
General and administrative expenses decreased to
Loss from operations was
Chimerix's balance sheet at
Today's Conference Call and Webcast
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
About
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. 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.
| CONSOLIDATED BALANCE SHEETS | ||||||||
| (in thousands, except share and per share data) | ||||||||
| (unaudited) | ||||||||
| ASSETS | ||||||||
| Current assets: | ||||||||
| Cash and cash equivalents | $ | 32,060 | $ | 20,605 | ||||
| Short-term investments, available-for-sale | 240,755 | 199,729 | ||||||
| Accounts receivable | 313 | 2,432 | ||||||
| Prepaid expenses and other current assets | 4,761 | 6,071 | ||||||
| Total current assets | 277,889 | 228,837 | ||||||
| Long-term investments | 29,802 | 124,040 | ||||||
| Property and equipment, net of accumulated depreciation | 3,020 | 3,045 | ||||||
| Other long-term assets | 93 | 70 | ||||||
| Total assets | $ | 310,804 | $ | 355,992 | ||||
| LIABILITIES AND STOCKHOLDERS' EQUITY | ||||||||
| Current liabilities: | ||||||||
| Accounts payable | $ | 4,217 | $ | 10,458 | ||||
| Accrued liabilities | 6,311 | 9,721 | ||||||
| Total current liabilities | 10,528 | 20,179 | ||||||
| Deferred rent | 306 | 354 | ||||||
| Total liabilities | 10,834 | 20,533 | ||||||
| Stockholders' equity: | ||||||||
| Preferred stock, | — | — | ||||||
| Common stock, | 46 | 46 | ||||||
| Additional paid-in capital | 684,015 | 675,591 | ||||||
| Accumulated other comprehensive loss, net | (269 | ) | (764 | ) | ||||
| Accumulated deficit | (383,822 | ) | (339,414 | ) | ||||
| Total stockholders' equity | 299,970 | 335,459 | ||||||
| Total liabilities and stockholders' equity | $ | 310,804 | $ | 355,992 | ||||
| CONSOLIDATED STATEMENTS OF OPERATIONS AND COMPREHENSIVE LOSS | ||||||||||||||||
| (in thousands, except share and per share data) | ||||||||||||||||
| (unaudited) | ||||||||||||||||
| Three Months Ended | Six Months Ended | |||||||||||||||
| 2016 | 2015 | 2016 | 2015 | |||||||||||||
| Revenues: | ||||||||||||||||
| Contract revenue | $ | 1,841 | $ | 2,598 | $ | 3,069 | $ | 3,833 | ||||||||
| Collaboration and licensing revenue | — | 1,545 | — | 1,548 | ||||||||||||
| Total revenues | 1,841 | 4,143 | 3,069 | 5,381 | ||||||||||||
| Operating expenses: | ||||||||||||||||
| Research and development | 13,759 | 21,860 | 34,695 | 39,365 | ||||||||||||
| General and administrative | 6,607 | 7,234 | 13,531 | 13,295 | ||||||||||||
| Total operating expenses | 20,366 | 29,094 | 48,226 | 52,660 | ||||||||||||
| Loss from operations | (18,525 | ) | (24,951 | ) | (45,157 | ) | (47,279 | ) | ||||||||
| Interest income, net | 377 | 136 | 749 | 199 | ||||||||||||
| Net loss | (18,148 | ) | (24,815 | ) | (44,408 | ) | (47,080 | ) | ||||||||
| Other comprehensive loss: | ||||||||||||||||
| Unrealized gain on investments, net | 75 | 1,144 | 496 | 1,769 | ||||||||||||
| Comprehensive loss | $ | (18,073 | ) | $ | (23,671 | ) | $ | (43,912 | ) | $ | (45,311 | ) | ||||
| Per share information: | ||||||||||||||||
| Net loss, basic and diluted | $ | (0.39 | ) | $ | (0.59 | ) | $ | (0.96 | ) | $ | (1.13 | ) | ||||
| Weighted-average shares outstanding, basic and diluted | 46,214,086 | 42,079,716 | 46,199,110 | 41,614,494 | ||||||||||||
CONTACT: Investor Relations: ir@chimerix.com orJesse Baumgartner Stern Investor Relations Jesse@sternir.com 212-362-1200 Media: Becky VonsiatskyW2O Group bvonsiatsky@w2ogroup.com 413-478-2003
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