"We have made meaningful progress advancing both the short-course oral brincidofovir program and the first of several confirmatory studies of IV brincidofovir. The single ascending dose study of IV brincidofovir (BCV) demonstrated with the first dose of 10 mg that we can achieve the plasma exposures that previously showed antiviral activity in the SUPPRESS and AdVise studies, but without the previously noted gastrointestinal (GI) limitations," said M.
Recent Highlights and Program Updates:
Full Data from Phase 1 Dose Escalation Study of Intravenous Brincidofovir in Healthy Subjects Reported
Data from all four cohorts of the Phase 1 study of IV BCV were presented at the recent Investor Event held on
Doses higher than those currently being explored for the above indications ("supratherapeutic") of IV BCV (50 mg given over two hours in Cohort 3, 50 mg given over four hours in Cohort 4) were also administered to evaluate the potential effects of BCV on QT interval and other safety parameters. A majority of the AEs reported were mild and self-limited. Four subjects in Cohort 3 reported drug-related AEs: one drug-related GI AE, two subjects with a mild headache, and one subject reported pain and irritation at the IV infusion site. In Cohort 4, five subjects reported nine drug-related AEs: three subjects with GI AEs, two subjects with headache, and one subject with reversible elevations of liver transaminases reported as an AE.
Therapeutic doses of IV BCV were thus very well tolerated, and no new adverse events were identified with the IV formulation of BCV compared with the large safety database for oral BCV.
Clinical Development of BCV Continues
Following discussions with European regulators,
Following on the encouraging data from the single ascending dose study of IV BCV,
Development of BCV for smallpox continues in collaboration with the Biomedical Advanced Research and Development Authority (BARDA). Following completion of a planned second animal efficacy study,
First Quarter 2017 Financial Results
Chimerix reported a net loss of $17.8 million, or $0.38 per basic and diluted share, for the first quarter of 2017. During the same period in 2016, Chimerix recorded a net loss of
Revenues for the first quarter of 2017 decreased to
Research and development expenses decreased to $12.7 million for the first quarter of 2017, compared to $20.9 million for the same period in 2016.
General and administrative expenses decreased to $6.6 million for the first quarter of 2017, compared to $6.9 million for the same period in 2016.
Loss from operations was $18.3 million for the first quarter of 2017, compared to a loss from operations of $26.6 million for the same period in 2016.
Today's Conference Call and Webcast
Chimerix will host a conference call and live audio webcast to discuss first quarter 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 3258363.
A live audio webcast of the call
will also be available on the Investors section of
Chimerix is a biopharmaceutical company dedicated to discovering, developing and commercializing medicines that improve outcomes for immunocompromised patients.
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)|
|Cash and cash equivalents||$||21,866||$||51,463|
|Short-term investments, available-for-sale||139,829||180,558|
|Prepaid expenses and other current assets||2,391||2,845|
|Total current assets||164,897||236,465|
|Property and equipment, net of accumulated depreciation||2,567||2,843|
|Other long-term assets||59||55|
|LIABILITIES AND STOCKHOLDERS' EQUITY|
|Total current liabilities||8,632||10,105|
|Preferred stock, |
|Common stock, |
|Additional paid-in capital||696,995||692,422|
|Accumulated other comprehensive loss, net||(109||)||(440||)|
|Total stockholders' equity||263,374||276,224|
|Total liabilities and stockholders' equity||$||272,407||$||286,770|
|CONSOLIDATED STATEMENTS OF OPERATIONS AND COMPREHENSIVE LOSS|
|(in thousands, except share and per share data)|
| Three Months Ended |
|Research and development||12,742||20,936|
|General and administrative||6,596||6,924|
|Total operating expenses||19,338||27,860|
|Loss from operations||(18,260||)||(26,632||)|
|Other comprehensive loss:|
|Unrealized gain on investments, net||331||421|
|Per share information:|
|Net loss, basic and diluted||$||(0.38||)||$||(0.57||)|
|Weighted-average shares outstanding, basic and diluted||46,573,394||46,184,134|
CONTACT: Investor Relations: email@example.com or Will O'Connor Stern Investor Relations Will@sternir.com 212-362-1200 Media: Becky Vonsiatsky
W2O Groupbvonsiatsky@w2ogroup.com 413-478-2003
News Provided by Acquire Media