Nov. 6, 2009 (PR Newswire) -- ROCKVILLE, Md., Nov. 6 /PRNewswire-FirstCall/ -- Novavax, Inc. (Nasdaq: NVAX) today announced financial results for the third quarter ended September 30, 2009 and reviewed its recent accomplishments and upcoming milestones.
Novavax's net loss for the third quarter of 2009 was $7.5 million, or $0.08 per share, compared to a net loss of $7.8 million, or $0.12 per share, for the same period last year.
For the nine-month period ended September 30, 2009, the net loss was $24.4 million, or $0.30 per share, compared to a net loss of $25.0 million, or $0.40 per share, for the comparable period in 2008. The decrease in the net loss was primarily due to a decrease in operating expenses as a result of staff reductions and other cost cutting initiatives partially offset by a decrease in revenue and the conclusion of our discontinued operations.
At September 30, 2009, Novavax had cash, cash equivalents and marketable securities of $34.4 million compared to approximately $33.9 million at December 31, 2008.
Dr. Rahul Singhvi, President and Chief Executive Officer of Novavax, stated: "We are continuing to make rapid progress with each of our vaccine development programs which are targeting some of the world's most pressing public health problems. Our partnerships in the United States, Spain, Mexico and India are accelerating the development of our VLP based 2009 H1N1 pandemic influenza and seasonal influenza vaccines and enabling us to prepare for their commercial-scale production. In addition, we recently selected a vaccine candidate against Respiratory Syncytial Virus (RSV), the most common cause of lower respiratory tract infection in infants and young adults. Our achievements to date reflect the clinical and commercial potential of our technology and the successful execution of our product development strategies."
Key accomplishments since the second quarter included the following:
-- In September, Novavax announced favorable results from a Phase II human
clinical trial of its trivalent seasonal influenza virus-like particle
(VLP) vaccine candidate. These results continue to support the planned
study of the vaccine in elderly adults scheduled for the fourth quarter
of this year and pave the way for the company to advance its seasonal
influenza VLP vaccine into Phase III studies next year.
-- In October, Novavax initiated a two-stage pivotal clinical study of its
novel 2009 H1N1 VLP pandemic influenza vaccine in Mexico, in
collaboration with Avimex Laboratories and GE Healthcare. Avimex is
providing financial support while GE Healthcare is providing its
single-use bioprocessing products for vaccine production. Pending
favorable results from the first stage of the study, the second stage
will be initiated in a larger cohort of 3,000 subjects. If the results
are clinically acceptable, they will be used to seek registration of
Novavax's 2009 H1N1 VLP pandemic influenza vaccine in Mexico and
potentially other countries.
-- In October, Novavax entered into a strategic collaboration with
Xcellerex, Inc. to expand Novavax's vaccine manufacturing process to
commercial scale and begin immediate production of Novavax's novel 2009
H1N1 VLP pandemic influenza vaccine for potential commercial sale in
Mexico.
-- Novavax received a Small Business Innovation and Research (SBIR) grant
from the National Institute of Allergy and Infectious Diseases of the
National Institutes of Health. The grant is to support a segment of the
company's preclinical research program for the Respiratory Syncytial
Virus (RSV) particle-based vaccine. The SBIR grant was valued at
approximately $246,000.
-- In October, CPL Biologicals Pvt. Ltd., the joint venture between Novavax
and Cadila Pharmaceuticals in India, began construction of a
state-of-the-art 25,000 square-foot manufacturing facility that will be
used to produce pandemic and seasonal influenza vaccines.
