March 1, 2016
By Mark Terry, BioSpace.com Breaking News Staff
In light of three failed clinical trials and disappointing financial statements, Durham, N.C.-based Chimerix cut about 20 percent of its workforce.
Chimerix focuses on the development of antiviral medications. At its recent fourth-quarter financial statements, the company reported a net loss of $117.4 million, or $2.67 per basic and diluted share for last year. The previous year, which ended Dec. 31, 2014, Chimerix reported a net loss of $59.3 million, which equals $1.80 per basic and diluted share.
Revenues for last year were $10.8, up from $4.0 million the previous year. That revenue is related to an increase in reimbursement expenses from an ongoing contract with the Biomedical Advanced Research and Development Authority (BARDA).
On Dec. 28, 2015, Chimerix announced that its oral antiviral drug brincidifovir failed its Phase III clinical trial. It was being evaluated in patients undergoing hematopoietic cell transplantation (HCT), and didn’t hit the primary endpoint for the prevention of clinically significant cytomegalovirus (CMV) infection.
In February, the company decided to stop two trials as a result of the disappointing data. The two Phase III trials closed were SUSTAIN and SURPASS in kidney transplant recipients. The company indicates it plans to conduct smaller trials of brincidofovir to confirm activity against BK virus.
“We remain confident in the antiviral activity shown by brincidofovir, and its significant potential as a much-needed treatment option for patients with adenovirus and other DNA viral infections,” said M. Michelle Berrey, president and chief executive officer of Chimerix, in a statement. “With the observation of a day 90 mortality of less than 40 percent in the approximately 100 patients with disseminated adenovirus disease in the AdVise study, and the anticipated spring readout of the historic controlled data, we strongly believe that there is a near-term path forward for this antiviral, and are well-capitalize to conduct any additional confirmatory study required for an adenovirus treatment submission. Following the recent presentation of 100 percent survival in the rabbitpox pivotal study of brincidofovir, we also anticipate completing the second pivotal animal study this year to enable an End of Phase II meeting with FDA for the treatment of smallpox.”
Despite operational losses in 2015 of $118.3 million, the company has $343 million in cash, which it plans to use to continue brincidofovir development, as well as other pipeline programs.
“We remain well-capitalized with $343 million on hand at the end of 2015,” said Tim Trost, Chimerix’s chief financial officer, in a statement, “and plan to use this financial strength to efficiently fund the development of brincidofovir and our other pipeline programs based upon a careful portfolio analysis and discuss with regulatory leaders in the months ahead. In light of the SUPPRESS results, in early 2016 we completed an approximate 20 percent reduction in our workforce. We expect our research and corporate expenses to trend downward this year prior to discussions with regulators and agreement on clinical development requirements. Once that path forward has been set, we would expect to provide more granular expense guidance.”
Company has not taken the news well. Shares traded on Aug. 5, 2015 for $57.43. Just prior to releasing news about the trials, shares traded on Dec. 23 for $35.78. On Dec. 28, shares plummeted to $6.62 per share. Stocks are currently trading for $4.61 per share.
