- Phase II RSV clinical trial data achieve protocol specified-objectives of safety and immunogenicity.
- Novel malaria vaccine candidate in India honored by the Vaccine World Summit India 2013 conference for having the "Most Promising Vaccine for Emerging Diseases in India."
- Positive U.S. inter-governmental-agency panel review to continue influenza vaccine-development contract.
- Strong financial position with cash of $45.4 million providing two-years of operations.
As of March 31, 2013, the company had $45.4 million in cash and cash equivalents and investments compared to $50.3 million as of December 31, 2012. Net cash used in operating activities for the first quarter of 2013 was $10.6 million compared to $4.2 million for the same period in 2012, a $6.4 million increase from the prior year. The increase in cash usage from the prior year was due to higher influenza-related billable activity associated with clinical trials in 2012 as compared to 2013. In addition, the increase was also associated with higher research and development spending including the company's RSV clinical trials and increased employee-related costs. Cash usage may fluctuate from period to period due to the timing of initiation and payments of clinical-related activities. The company expects to ultimately initiate later-stage seasonal and pandemic influenza clinical trials upon completion of its process development enhancements, which should have a positive impact on cash usage in the future."Highlighting a very eventful quarter were the impressive results we reported last month from the Phase II clinical trial of our RSV vaccine candidate, which has the potential to become a new standard of preventive care if later-stage studies are successful," said Stanley C. Erck, President and Chief Executive Officer of Novavax. "The vaccine induced clinically meaningful immunity against RSV infection with no apparent safety concerns, suggesting it may protect infants through maternal immunization – an important consideration in preventing severe respiratory disease due to RSV. In the meantime, we are continuing our work in collaboration with the U.S. Department of Health and Human Services' Office of Biomedical Advanced Research and Development Authority (BARDA) to develop seasonal and pandemic influenza vaccines and prepare for later-stage clinical trials and are making important progress in both programs. We shall continue to manage our financial resources carefully as we execute these development programs and look forward to reporting on our clinical and corporate progress later this year."
Key Highlights during and since the First Quarter of 2013:
- In April 2013, we announced that top-line data from the Phase II dose-ranging clinical trial of our respiratory syncytial virus (RSV) vaccine candidate in women of childbearing age accomplished the clinical trial's protocol-specified objectives and support progression to the next stage of advanced clinical testing. The clinical trial represents an important step towards establishing the safety and immunogenicity of this vaccine candidate for use in a maternal immunization strategy.
- Also in April 2013, we appointed Amy B. Fix, Vice President of Regulatory Affairs, with responsibility for directing regulatory strategy and coordinating the company's interactions with regulatory agencies that oversee the development and commercialization of our vaccine product candidates.
- In March 2013, our collaboration with CPL Biologicals and the International Centre for Genetic Engineering and Biotechnology to develop a novel malaria vaccine in India, was honored by the Vaccine World Summit India 2013 conference for having the "Most Promising Vaccine for Emerging Diseases in India." This was one of five inaugural awards honoring achievements in India's vaccine industry.
- In January 2013, BARDA decided to continue to support our contract to develop seasonal influenza and pandemic (H5N1) influenza vaccine candidates following an inter-governmental-agency panel review of our vaccine-development contract with BARDA in late 2012.
|CONDENSED STATEMENTS OF OPERATIONS|
|(in thousands, except per share information)|
|Three Months Ended|
|Revenue||$ 3,833||$ 4,642|
|Costs and expenses:|
|Cost of revenue||1,712||3,786|
|Research and development||9,432||5,338|
|General and administrative||2,694||2,985|
|Total costs and expenses||13,838||12,109|
|Loss from operations||(10,005)||(7,467)|
|Interest income (expense), net||26||30|
|Change in fair value of warrant liability||―||101|
|Loss from operations before income tax||(9,979)||(7,336)|
|Income tax expense||17||―|
|Net loss||$ (9,996)||$ (7,336)|
|Basic and diluted net loss per share||$ (0.07)||$ (0.06)|
|Basic and diluted weighted average number of common shares outstanding||148,448||120,558|
|SELECTED BALANCE SHEET DATA|
|March 31, 2012||December 31, 2012|
|Cash and cash equivalents||$ 9,023||$ 17,399|
|Total current assets||51,722||50,408|
|Total notes payable and capital lease obligation||1,961||1,205|
|Total stockholders' equity||77,568||80,240|
CONTACT: Frederick W. Driscoll VP, Chief Financial Officer and Treasurer Novavax, Inc. 240-268-2000