Nasdaq GlobeNewswire

Novavax Reports First Quarter 2017 Financial Results


GAITHERSBURG, Md., May 08, 2017 (GLOBE NEWSWIRE) -- Novavax, Inc., (Nasdaq:NVAX) today announced its financial results for the first quarter ended March 31, 2017.

First Quarter Achievements:

  • Enrollment continued during the second global season in the RSV Phase 3 Prepare(TM) clinical trial for infants via maternal immunization. Enrollment in the first quarter of 2017 transitioned from the northern hemisphere to southern hemisphere sites in Argentina, Australia, Chile, New Zealand and South Africa. The second season of enrollment has benefitted greatly from the establishment of the operational infrastructure and experience from the first global season, resulting in material increases in enrollment and enhanced momentum as we move towards the third global season of enrollment.
  • Initiation of a randomized, observer-blinded, multi-arm, dose-ranging Phase 2 clinical trial, in one and two dose formulations, both with and without adjuvants, of its RSV F Vaccine in older adults (60 years of age and older). The trial will evaluate safety and immunogenicity of these formulations in older adults as measured by serum microneutralization titers against RSV/A and RSV/B, palivizumab competing antibodies ("PCA") and anti-F IgG.

Anticipated 2017 Events:

  • Announce top-line data from the Phase 2 safety and immunogenicity clinical trial of the RSV F vaccine in older adults in the next 90 days.
  • File revised study documents and conduct an informational analysis of the Prepare trial that would provide an indication of the RSV F Vaccine's potential efficacy against the trial's primary endpoint before the end of the year.
  • Initiate a Phase 1 clinical trial of the Company's recombinant seasonal influenza vaccine candidate before the end of the year.
  • Initiate a Phase 1 clinical trial of the Company's Zika vaccine candidate before the end of the year.


"We continued to make significant progress in the execution of our two key clinical trials of our RSV F vaccine for both infant via maternal immunization and in older adults. We look forward to reporting important clinical data from our older adult trial in the next 90 days. We've also been in discussion with the FDA about conducting an informational analysis of the Prepare trial that would provide an indication of our vaccine's potential efficacy. From these discussions, we believe we can conduct this analysis in late 2017," said Stanley C. Erck, President and CEO. "In addition, we are seeing the continued adoption and use of our proprietary adjuvant, Matrix-M, in a number of internal and partnered programs."

Financial Results for the Three Months Ended March 31, 2017

Novavax reported a net loss of $43.9 million, or $0.16 per share, for the first quarter of 2017, compared to a net loss of $77.3 million, or $0.29 per share, for the first quarter of 2016.

Novavax revenue in the first quarter of 2017 increased 35% to $5.7 million, compared to $4.2 million for the same period in 2016, primarily due to increased revenue recorded under the BMGF grant relating to our ongoing Prepare clinical trial.

Research and development expenses decreased 45% to $37.7 million in the first quarter of 2017, compared to $69.0 million for the same period in 2016. The decrease was primarily due to reduced costs associated with the clinical trials and development activities of our RSV F Vaccine and lower employee-related costs.

General and administrative expenses decreased 16% to $8.9 million in the first quarter of 2017, compared to $10.5 million for the same period in 2016. The decrease was primarily due to lower professional fees for pre-commercialization activities.

Interest income (expense), net for the first quarter of 2017 was ($3.0) million, compared to ($1.9) million for the same period in 2016.

As of March 31, 2017, the company had $211.2 million in cash and cash equivalents and marketable securities compared to $235.5 million as of December 31, 2016. Net cash used in operating activities for the first quarter of 2017 was $38.6 million, compared to $69.8 million for same period in 2016. The decrease in cash usage was primarily due to decreased costs relating to our RSV F Vaccine and lower employee-related costs.

Conference Call

Novavax management will host its quarterly conference call today at 4:30 p.m. ET. The dial-in number for the conference call is (877) 212-6076 (Domestic) or (707) 287-9331 (International), passcode 15607801. A replay of the conference call will be available starting at 7:30 p.m. ET on May 8, 2017 until 7:30 pm ET on May 15, 2017. To access the replay by telephone, dial (855) 859-2056 (Domestic) or (404) 537-3406 (International) and use passcode 15607801.

A webcast of the conference call can also be accessed via a link on the home page of the Novavax website ( or through the "Investor Info"/"Events" tab on the Novavax website. A replay of the webcast will be available through the "Investor Info"/"Events" tab on the Novavax website until July 3, 2017.

About Novavax

Novavax, Inc. (Nasdaq:NVAX) is a clinical-stage biotechnology company committed to delivering novel products to prevent a broad range of infectious diseases. Our recombinant nanoparticles and Matrix-M(TM) adjuvant technology are the foundation for groundbreaking innovation that improves global health through safe and effective vaccines. Additional information about Novavax is available on the Company's website,

About RSV

Respiratory syncytial virus (RSV) is the most common cause of lower respiratory tract infections and the leading viral cause of severe lower respiratory tract disease in infants and young children worldwide, with estimated annual infection and mortality rates of 64 million and 160,000, respectively.1 In the U.S., RSV is the leading cause of hospitalization of infants, and globally, is second only to malaria as a cause of death in children under 1 year of age. 3 Despite the induction of post-infection immunity, repeat infection and lifelong susceptibility to RSV is common. Currently, there is no approved RSV vaccine available. 5

Forward-Looking Statements

Statements herein relating to the future of Novavax and the ongoing development of its vaccine and adjuvant products are forward-looking statements. Novavax cautions that these forward looking statements are subject to numerous risks and uncertainties, which could cause actual results to differ materially from those expressed or implied by such statements. These risks and uncertainties include those identified under the heading "Risk Factors" in the Novavax Annual Report on Form 10-K for the year ended December 31, 2016 and the Report on Form 10-Q for the period ended March 31, 2017, both as filed with the Securities and Exchange Commission (SEC). We caution investors not to place considerable reliance on the forward-looking statements contained in this press release. You are encouraged to read our filings with the SEC, available at, for a discussion of these and other risks and uncertainties. The forward-looking statements in this press release speak only as of the date of this document, and we undertake no obligation to update or revise any of the statements. Our business is subject to substantial risks and uncertainties, including those referenced above. Investors, potential investors, and others should give careful consideration to these risks and uncertainties.

1 Nair, H. et al. Global burden of acute lower respiratory infections due to respiratory syncytial virus in young children: a systematic review and meta-analysis. Lancet, 2010; 375: 1545-1555.

2 Hall, C.B. et al. Respiratory Syncytial Virus-Associated hospitalizations Among Children Less Than 24 Months of Age. Pediatrics, 2013; 132(2): E341-348.

3 Oxford Vaccine Group:

4 Glezen, W.P. et al. Risk of primary infection and reinfection with respiratory syncytial virus. Am J Dis Child, 1986; 140:543-546. 

5 Glenn GM, et al. Modeling maternal fetal RSV F vaccine induced antibody transfer in guinea pigs. Vaccine, 2015; In press.

(in thousands, except per share information)
      Three Months Ended  
      March 31,  
        2017       2016    
Revenue $      5,680     $   4,218    
  Research and development   37,654       68,952    
  General and administrative   8,852       10,528    
    Total expenses   46,506       79,480    
Loss from operations   (40,826 )     (75,262 )  
Interest income (expense), net   (3,039 )     (1,957 )  
Other income (expense)   11       (33 )  
Net loss $      (43,854 )   $   (77,252 )  
Basic and diluted net loss per share $      (0.16 )   $   (0.29 )  
Basic and diluted weighted average        
  number of common shares outstanding       274,178       270,179    


(in thousands)
  March 31,  
31, 2016
Cash and cash equivalents $   95,847     $   144,353  
Marketable securities     115,331         91,126  
Total current assets     258,449         287,830  
Working capital     201,951         221,424  
Total assets     361,504         394,301  
Total notes payable and capital lease obligation       316,714         316,376  
Total stockholders' deficit     (29,099 )       (5,546 )



Investor Relations
Novavax, Inc.
Andrea N. Flynn, Ph.D.
Associate Director, Investor Relations  
Westwicke Partners
John Woolford

Russo Partners, LLC
David Schull
Todd Davenport, Ph.D. 

This announcement is distributed by Nasdaq Corporate Solutions on behalf of Nasdaq Corporate Solutions clients.
The issuer of this announcement warrants that they are solely responsible for the content, accuracy and originality of the information contained therein.
Source: Novavax, Inc. via Globenewswire

Om Nasdaq GlobeNewswire

Nasdaq GlobeNewswire
Nasdaq GlobeNewswire
One Liberty Plaza - 165 Broadway
NY 10006 New York

+1 212 401 8700

NASDAQ (NASDAQ: NDAQ) is a leading provider of trading, exchange technology, information and public company services across six continents.

Følg saker fra Nasdaq GlobeNewswire

Registrer deg med din epostadresse under for å få de nyeste sakene fra Nasdaq GlobeNewswire på epost fortløpende. Du kan melde deg av når som helst.

Siste saker fra Nasdaq GlobeNewswire

Comodo CA Sees 35 Percent Year-Over-Year Increase in EV Certificates22.3.2018 15:47Pressemelding

EV SSL will be a topic of discussion at the Comodo CA booth during RSA 2018 CLIFTON, N.J., March 22, 2018 (GLOBE NEWSWIRE) -- Comodo CA, a worldwide leader in digital identity solutions, will address evolving cyberthreats and the increasing importance Extended Validation (EV) TLS/SSL certificates play in securing websites and inspiring consumer trust at the RSA Conference 2018, San Francisco, April 16 - 20. According to the Feb 2018 Netcraft report, Comodo CA has seen a 35 percent year-over-year increase of EV certificate units* making it one of the fastest growing providers of high assurance certificates. The volume of EV certificates globally also saw a record year in 2017 as more and more businesses adopt EV as standard practice for their websites. The demand for stronger, more secure EV certificates comes in the wake of increased phishing websites using Domain Validated (DV) certificates. Phishing websites imitate legitimate websites to steal customers' funds and identities. Phishi

CBT Pharmaceuticals to Grow Immuno-Oncology Pipeline by License Agreement of CrownBio CTLA-4 Antibody22.3.2018 14:43Pressemelding

SAN DIEGO, March 22, 2018 (GLOBE NEWSWIRE) -- Crown Bioscience, a wholly-owned subsidiary of Crown Bioscience International (TWSE:6554) and a global drug discovery and development services company providing translational platforms to advance oncology, inflammation, cardiovascular and metabolic disease research, announced today a strategic licensing agreement with CBT Pharmaceuticals (CBT), a U.S. and China-based innovative biopharmaceutical company committed to becoming a leader in the discovery and development of oncology combination therapies. The agreement gives CBT exclusive world-wide development and commercialization rights to a novel, recombinant, human monoclonal antibody which targets a differentiated epitope on the cytotoxic T-lymphocyte antigen-4 (CTLA-4) molecule. Binding of this antibody to CTLA-4 blocks the interaction of CTLA-4 with its ligands CD80/CD86 thus allowing the cytotoxic T cells to function actively. Under the terms of this global licensing agreement, CBT gain

Cloudflare Announces Mobile SDK to Monitor Network Performance for Applications22.3.2018 14:00Pressemelding

New free solution delivers network analytics to any mobile app developer SAN FRANCISCO, March 22, 2018 (GLOBE NEWSWIRE) -- Cloudflare, the leading Internet performance and security company, today announced the Cloudflare Mobile SDK, a free solution that enables any mobile app developer to understand network performance and metrics. Consumers are frustrated by mobile apps that are slow, crash, or deliver errors that degrade the user experience. For mobile app developers, a bad user experience means poor reviews, lower engagement, and reduced conversion on business metrics. Delivering consistent app performance requires focusing on every link in the chain: app code, network calls between the app and edge networks, and server infrastructure. There are a number of solutions that give developers analytics on their applications, but there has never been a way for app developers to understand how often their apps fail due to network errors. App developers easily integrate the Cloudflare Mobil

Compuware: Survey Shows Critical Mainframe Workloads Increasing While Mainframe Staff Losses Remain Unfilled22.3.2018 13:00Pressemelding

Many Organizations Not Measuring, Prioritizing Vital Key Performance Indicators 57 percent of enterprises with a mainframe currently run more than half of their business-critical applications on the platform-with that number expected to increase to 64 percent by next year. 72 percent of customer-facing applications are completely or very dependent on mainframe processing. Enterprises have only replaced 37 percent of the mainframe workforce lost over the past five years. Many organizations surveyed are not currently measuring velocity or efficiency key performance indicators, putting them at a disadvantage in the digital age. DETROIT, March 22, 2018 (GLOBE NEWSWIRE) -- The mainframe is becoming more important to large enterprises, with the percentage of organizations running at least half their business-critical applications on that platform expected to increase next year. However, the loss of skilled mainframe staff, and the failure to subsequently fill these positions, pose significan

SEMAFO: Construction of Boungou Mine 87% Complete22.3.2018 12:00Pressemelding

Dry Plant Commissioning Underway MONTREAL, March 22, 2018 (GLOBE NEWSWIRE) -- SEMAFO Inc. (TSX:SMF) (OMX:SMF) is pleased to announce that construction of the Boungou Mine in Burkina Faso is 87% complete, with first gold scheduled to be poured early in the third quarter of 2018. In a first step towards this milestone, the Corporation began commissioning activities on dry plant equipment this week. All amounts are in US dollars unless otherwise stated. Over the coming weeks, as construction continues, the crushing and reclaim circuit equipment required for initial production will undergo testing. The power plant, which was over 90% complete at the end of February, has been partially operational since early March. As at February 28, 2018, the additional key achievements had been made: Development on budget with US$182 million of the US$231 million capital expenditure incurred Construction of the mine 87% complete Completion of some 94% of structural steel and mechanical installation Pipin

Lexin Appoints Two New Directors to Expand Board22.3.2018 02:49Pressemelding

SHENZHEN, China, March 22, 2018 (GLOBE NEWSWIRE) -- LexinFintech Holdings Ltd. ("Lexin" or the "Company") (NASDAQ:LX), a leading online consumer finance platform for educated young adults in China, today announced the appointment of Dr. Neng Wang as an independent director of the Company's board of directors (the "Board"), and the appointment of Mr. Xiaoguang Wu as a director of the Board, effective on March 20, 2018. These two appointments have expanded the Board to eight members, from six previously. Dr. Wang is also serving as a member of the audit committee, the compensation committee and the nominating and corporate governance committee of the Board. Dr. Wang has replaced Mr. Keyi Chen, Mr. Jared Yi Wu, and Mr. Yibo Shao respectively from the abovementioned committees of the Board, all of whom remain as directors on the Board. Dr. Wang has been Chong Khoon Lin Professor of Real Estate at Columbia Business School since July 2007, and a research associate at the National Bureau of E

I vårt presserom finner du alle våre siste saker, kontaktpersoner, bilder, dokumenter og annen relevant informasjon om oss.

Besøk vårt presserom