PRESS RELEASES<< Back
Chimerix Announces Third Quarter 2018 Financial Results
- Conference Call at
“We have made important progress throughout the year that we believe will position
Recent Highlights and Program Updates:
Detailed AdVance Data Presented at IDWeek
At IDWeek 2018 in early October,
The analysis considered six different dynamic measures of AdV viral load and their association with all-cause mortality. Importantly, all measures were independently associated with mortality, including the viral burden measured as time-averaged area-under-the-curve for AdV viral load over 16 weeks (AAUC0-16). As with many viral infections, peak viral load and the duration of the high viral load were both predictors of poor clinical outcomes. The area-under-the-curve includes both measures: viral peak and persistence. As the primary endpoint in the ongoing AdAPT study, the company believes AdV AAUC0-16 is thus likely to reflect the superior antiviral effect of oral brincidofovir (BCV) compared with current standard of care and may also demonstrate the improved short-term outcomes in subjects who are treated with oral BCV.
Data from Multiple Ascending Dose Study of IV Brincidofovir Presented at IDWeek
The study evaluated the safety and PK of four doses of IV BCV in 27 healthy individuals who were randomized 3:1 to receive IV BCV or placebo in sequential cohorts of escalating doses. Individuals receiving IV BCV were given a 10 mg dose in a two-hour infusion twice a week for two weeks or a 20 mg dose in either a one- or two-hour infusion once a week for four weeks. Twice weekly doses of IV BCV at 10 mg provided similar blood levels of the drug as the oral BCV 100 mg dose previously studied in late-stage clinical trials, with no reported diarrhea or other gastrointestinal adverse events.
Preclinical Data Demonstrating Antiviral Activity of BCV Against Polyomavirus Presented at Kidney Week 2018
The two studies evaluated BCV’s effect against Murine Polyoma Virus (MuPyV), a mouse polyomavirus closely related to the human BK virus. In these studies, mice with MuPyV were treated with BCV either 24 hours after being infected or prophylactically for a full week prior to infection. Data from the two studies show that BCV demonstrated significant antiviral activity against MuPyV and showed no safety signals across BCV doses administered. In mice treated after infection with MuPyV, BCV delivered via intraperitoneal injection once daily, twice weekly or once weekly reduced kidney viral loads by 100-fold relative to placebo. These data along with data from the company’s ongoing Phase 2 studies of IV BCV are expected to inform the dose regimen for the company’s planned Phase 2/3 studies.
The AdAPT Study (Adenovirus after Allogeneic Pediatric Transplantation) is open for enrollment in
IV BCV Phase 2 Studies Continue to Initiate in the US and
Sites in the US and
Final Animal Studies for Brincidofovir for the Treatment of Smallpox
CMX521 for Norovirus
- No safety concerns were identified with single oral doses of CMX521 up to 2400 mg the top dose tested
- CMX521 plasma exposures increased in a less-than-proportional manner with escalating single oral dose administration
Clinical testing of CMX521 is ongoing in conjunction with in vitro studies in cultured human intestinal cells and recently described animal models of norovirus to assess antiviral efficacy.
Third Quarter 2018 Financial Results
Revenues for the third quarter of 2018 decreased to
Research and development expenses decreased to
General and administrative expenses decreased to
Loss from operations was
Today's Conference Call and Webcast
Chimerix will host a conference call and live audio webcast to discuss third 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 4646308.
A live audio webcast of the call will also be available on the Investors section of
CMX521 is a nucleoside antiviral identified from the
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 our current or future clinical trials of brincidofovir may not be successful, that the 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.
|CONSOLIDATED BALANCE SHEETS|
|(in thousands, except share and per share data)|
|September 30,||December 31,|
|Cash and cash equivalents||$||22,991||$||18,548|
|Short-term investments, available-for-sale||160,367||132,972|
|Prepaid expenses and other current assets||3,028||3,331|
|Total current assets||186,718||156,533|
|Property and equipment, net of accumulated depreciation||1,363||1,894|
|Other long-term assets||51||72|
|LIABILITIES AND STOCKHOLDERS' EQUITY|
|Total current liabilities||9,385||13,196|
|Preferred stock, $0.001 par value, 10,000,000 shares authorized at September 30, 2018 and December 31, 2017; no shares issued and outstanding as of September 30, 2018 and December 31, 2017||—||—|
|Common stock, $0.001 par value, 200,000,000 shares authorized at September 30, 2018 and December 31, 2017; 50,627,237 and 47,505,532 shares issued and outstanding as of September 30, 2018 and December 31, 2017, respectively||51||47|
|Additional paid-in capital||731,060||709,514|
|Accumulated other comprehensive loss, net||(661||)||(963||)|
|Total stockholders’ equity||189,144||221,810|
|Total liabilities and stockholders’ equity||$||198,696||$||235,230|
|CONSOLIDATED STATEMENTS OF OPERATIONS AND COMPREHENSIVE LOSS|
|(in thousands, except share and per share data)|
|Three Months Ended September 30,||Nine Months Ended September 30,|
|Research and development||11,892||12,157||39,963||36,535|
|General and administrative||5,187||6,650||18,575||19,530|
|Total operating expenses||17,079||18,807||58,538||56,065|
|Loss from operations||(16,710||)||(17,910||)||(56,186||)||(53,415||)|
|Other (expense) income:|
|Unrealized loss on equity investment||(99||)||-||(311||)||-|
|Other comprehensive loss:|
|Unrealized gain (loss) on investments, net||180||(6||)||302||(1,041||)|
|Per share information:|
|Net loss, basic and diluted||$||(0.33||)||$||(0.37||)||$||(1.14||)||$||(1.10||)|
|Weighted-average shares outstanding, basic and diluted||48,172,354||47,065,756||47,875,895||46,836,099|
Source: Chimerix, Inc.