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Novavax Reports Fourth Quarter and Year-End 2014 Financial Results
Corporate Highlights
Fourth Quarter and Subsequent Achievements:
RSV
- Initiated a Phase 2 clinical trial of its RSV F-Protein nanoparticle vaccine candidate (RSV F Vaccine) in 1,600 elderly adults (≥60 years of age);
- Received the
U.S. Food and Drug Administration's (FDA ) Fast Track Designation of our RSV F Vaccine for protection of infants via maternal immunization, which, among other advantages, provides the potential for priority review (shorter Biologics License Application review) that could result in improved timeline to licensure; - Initiated enrollment in a Phase 1 clinical trial of our RSV F Vaccine in healthy children, the first study of this vaccine candidate to be conducted in a pediatric population; and
- Presented new positive data from the first clinical study of our RSV F Vaccine in women of childbearing age at the 8th
Vaccine & ISV Congress , showing 50% reduction in infection in the vaccinated women relative to placebo. This data suggests that the vaccine may be efficacious in future clinical testing.
Influenza
- Initiated a randomized, observer-blinded, dose-ranging Phase 2 clinical trial of our recombinant quadrivalent seasonal influenza virus-like particle (VLP) vaccine candidate (Seasonal Influenza VLP) in 400 healthy adults. This trial is being conducted under our contract with the
U.S. Department of Health and Human Services ,Biomedical Advanced Research and Development Authority (BARDA) (Contract No. HHSO 100201100012C) for the development ofNovavax ' recombinant vaccines to address seasonal influenza and influenza strains with pandemic potential; and - Received the
FDA's Fast Track Designation of our Pandemic H7N9 Influenza VLP vaccine candidate (Pandemic H7N9 VLP) with Matrix-M™ adjuvant, which recognizes the public health risks of the H7N9 strain and may allow for an improved timeline to licensure via the potential for accelerated approval and priority review.
Ebola
- Initiated a novel Ebola Glycoprotein (GP) recombinant nanoparticle vaccine candidate (EBOV GP Vaccine) program based on the currently circulating Makona strain (previously referred to as the
Guinea strain) of Ebola virus; - Presented positive pre-clinical results at the 8th
Vaccine & ISV Congress of our EBOV GP Vaccine with Matrix-M adjuvant, showing seroprotective antibodies and cross-neutralization to a previously circulating Ebola virus strain; - Announced significant immunogenicity and efficacy data demonstrating the EBOV GP Vaccine is the first subunit Ebola GP-based vaccine to provide protection in non-human primates. Non-human primates received two injections of a 5µg dose of the EBOV GP Vaccine with Matrix-M adjuvant. As expected, the challenge was lethal for the control animal whereas, in sharp contrast, 100% of the immunized animals were protected; and
- Initiated a randomized, observer-blinded, dose-ranging Phase 1 clinical trial of our EBOV GP Vaccine in
Australia to evaluate the safety and immunogenicity of the vaccine, with and without Matrix-M adjuvant, in 230 healthy adults between 18 and 50 years of age.
2015 Anticipated Events:
- Announce top-line data from the Phase 1 clinical trial our EBOV GP Vaccine in mid-2015;
- Announce top-line data from the Phase 2 clinical trial of our Seasonal Influenza VLP in the second quarter of 2015;
- Announce top-line data from the Phase 2 clinical trial of our RSV F Vaccine in healthy women in their third trimester of pregnancy in the third quarter of 2015;
- Announce top-line data from the Phase 2 clinical trial of our RSV F Vaccine in elderly adults in the third quarter of 2015; and
- Announce top-line data from the Phase 1 clinical trial of our RSV F Vaccine in healthy pediatrics in late 2015 or in the first half of 2016.
"We have initiated five clinical trials within the last six months, including advancing both our RSV and seasonal influenza programs into Phase 2 clinical trials, while introducing our new Ebola vaccine into the clinic," said
Financial Results for the Three and Twelve Months Ended
The cost of government contracts revenue in the fourth quarter of 2014 increased 9% to
Research and development expenses increased 87% to
General and administrative expenses increased 24% to
As of
Conference Call
A replay of the conference call will be available starting at
About
Forward-Looking Statements
Statements herein relating to the future of
| NOVAVAX, INC. | ||||
| CONDENSED STATEMENTS OF OPERATIONS | ||||
| (in thousands, except per share information) | ||||
| Three Months Ended | Twelve Months Ended | |||
| December 31, | December 31, | |||
| 2014 | 2013 | 2014 | 2013 | |
| (unaudited) | ||||
| Revenue | $ 6,724 | $ 8,748 | $ 30,659 | $ 20,915 |
| Costs and expenses: | ||||
| Cost of government contracts revenue | 2,837 | 2,602 | 14,987 | 8,222 |
| Research and development | 30,495 | 16,319 | 79,435 | 50,308 |
| General and administrative | 5,056 | 4,080 | 19,928 | 14,819 |
| Total costs and expenses | 38,388 | 23,001 | 114,350 | 73,349 |
| Loss from operations | (31,664) | (14,253) | (83,691) | (52,434) |
| Interest income (expense), net | 118 | 10 | 129 | 27 |
| Other income, net | ― | 192 | ― | 182 |
| Realized gains on marketable securities | ― | ― | 615 | ― |
| Change in fair value of warrant liability | ― | ― | ― | 267 |
| Loss from operations before income tax expense | (31,546) | (14,051) | (82,947) | (51,958) |
| Income tax expense | ― | 3 | ― | 25 |
| Net loss | $ (31,546) | $ (14,054) | $ (82,947) | $ (51,983) |
| Basic and diluted net loss per share | $ (0.13) | $ (0.07) | $ (0.37) | $ (0.31) |
| Basic and diluted weighted average number of common shares outstanding | 238,519 | 208,538 | 225,848 | 169,658 |
| SELECTED BALANCE SHEET DATA | ||
| (in thousands) | ||
| December 31, | December 31, | |
| 2014 | 2013 | |
| Cash and cash equivalents | $ 32,335 | $ 119,471 |
| Marketable securities | 135,721 | 13,597 |
| Total current assets | 188,158 | 145,001 |
| Working capital | 154,042 | 126,879 |
| Total assets | 276,002 | 235,125 |
| Total notes payable and capital lease obligations | 1,173 | 2,184 |
| Total stockholders' equity | 229,618 | 203,234 |
CONTACT:Barclay A. Phillips SVP,Chief Financial Officer and Treasurer Novavax, Inc. 240-268-2000
