Novavax Third Quarter and Subsequent Achievements
- Announced positive top-line data from a Phase 2 clinical trial of its RSV F-protein recombinant nanoparticle vaccine candidate (RSV F Vaccine) in older adults (60 years of age and older). The vaccine was well-tolerated and fulfilled the Company's expectations on the primary, secondary and exploratory objectives of the trial. The trial is the first to demonstrate efficacy of an active RSV immunization in any clinical trial population.
- Announced positive top-line data from a Phase 2 clinical trial of its RSV F Vaccine to protect infants via maternal immunization. Significant anti-F, PCA and microneutralizing antibody responses were elicited in mothers and efficient antibody transfer from mothers to infants was observed.
- Announced that it has been awarded a grant of up to
$89 millionby the Bill & Melinda Gates Foundationto support development of the RSV F Vaccine Phase 3 clinical trial in pregnant women. This grant will also support regulatory licensing efforts, providing a path to WHO prequalification. Upon licensure, Novavax has agreed to make the RSV F Vaccine affordable and accessible to people in the developing world.
- Announced positive top-line data from a Phase 1 clinical trial of its RSV F Vaccine in healthy children two to six years of age. All RSV F Vaccine formulations and regimens were well-tolerated and highly immunogenic.
- Commenced enrollment in a Phase 2 rollover clinical trial of its RSV F Vaccine in older adults. The trial is a randomized, observer-blinded, placebo-controlled rollover trial designed to enroll the same 1600 older adults who participated in the recently concluded prior Phase 2 trial.
- Announced positive top-line data from a Phase 2 trial of its recombinant quadrivalent seasonal influenza virus-like particle candidate (Quadrivalent Seasonal Influenza VLP). The trial, funded in whole or part with Federal funds from the Company’s contract with the
Department of Health and Human Services, Biomedical Advanced Research and Development Authority(HHS BARDA) (Contract No. HHSO 100201100012C), demonstrated that the Quadrivalent Seasonal Influenza VLP vaccine candidate was well-tolerated with no vaccine-related serious adverse events. The trial met its immunogenicity targets and demonstrated potential to meet the Center for Biological Evaluation and Research(CBER) criteria for accelerated approval.
- Delivered positive top-line data from a Phase 1 clinical trial of its Ebola virus glycoprotein (GP) recombinant nanoparticle vaccine (Ebola GP Vaccine) candidate adjuvanted with Matrix-M™. The trial demonstrated that the adjuvanted Ebola GP Vaccine was highly immunogenic, well-tolerated and resulted in significant antigen dose-sparing.
- Hosted its 3rd Annual Analyst and Investor Meeting.
- Initiation of a Phase 3 trial of the RSV F Vaccine in older adults
Near-term Anticipated Events
- Initiation of a Phase 3 trial of the RSV F Vaccine to protect infants via maternal immunization, contingent upon discussions with regulatory authorities
“The initiation of the first Phase 3 trial of our RSV F Vaccine in older adults underscores our accomplishments to date and positions the company to bring the first RSV vaccine to market. Our recent data announcements demonstrate the safety and robust immunogenicity of the RSV F Vaccine across all three target populations: older adults; infants via maternal immunization; and pediatrics,” said
“During the third quarter, we delivered positive results from five key clinical programs including our RSV F Vaccine for older adults, infants via maternal immunization and pediatrics, as well as our Seasonal Influenza Vaccine, and our Ebola GP Vaccine. These results, coupled with today’s initiation of our Phase 3 trial of our RSV F Vaccine in older adults, demonstrate Novavax’ ability to successfully advance our clinical stage programs along aggressive timelines,” said
Financial Results for the Three and Nine Months Ended
The cost of government contracts revenue in the third quarter of 2015 decreased 32% to
Research and development expenses increased 45% to
General and administrative expenses increased 90% to
A replay of the conference call will be available starting at
Statements herein relating to the future of
|CONDENSED CONSOLIDATED STATEMENTS OF OPERATIONS|
|(in thousands, except per share information)|
|Three Months Ended||Nine Months Ended|
|September 30,||September 30,|
|Costs and expenses:|
|Cost of government contracts revenue||2,747||4,027||8,054||12,150|
|Research and development||27,917||19,219||78,686||48,940|
|General and administrative||9,060||4,757||21,991||14,871|
|Total costs and expenses||39,724||28,003||108,731||75,961|
|Loss from operations||(33,199||)||(19,789||)||(78,334||)||(52,026||)|
|Interest income (expense), net||130||81||324||10|
|Other income (expense)||(51||)||(19||)||(121||)||―|
|Realized gains on marketable securities||―||―||―||615|
|Basic and diluted net loss per share||$||(0.12||)||$||(0.08||)||$||(0.30||)||$||(0.23||)|
|Basic and diluted weighted average|
|number of common shares outstanding||269,554||238,304||259,703||221,578|
|SELECTED CONSOLIDATED BALANCE SHEET DATA|
|Cash and cash equivalents||$||138,144||$||32,335|
|Total current assets||310,102||188,158|
|Total notes payable and capital lease obligation||664||1,173|
|Total stockholders’ equity||367,016||229,618|
Novavax, Inc. Barclay A. PhillipsSVP, Chief Financial Officer and Treasurer Andrea N. Flynn, Ph.D. Senior Manager, Investor Relations firstname.lastname@example.org 240-268-2000 Russo Partners, LLC David Schull Todd Davenport, Ph.D. email@example.com firstname.lastname@example.org 212-845-4271