GlobeNewswire

Novavax Reports Second Quarter 2018 Financial Results

Del

Novavax Delivers on Key Milestones Supporting its 2018 Objectives

Company to Host Conference Call Today at 4:30 pm ET

GAITHERSBURG, Md., Aug. 08, 2018 (GLOBE NEWSWIRE) -- Novavax, Inc. (Nasdaq: NVAX) today announced its financial results and operational highlights for the second quarter and six months ended June 30, 2018.

“In keeping with our stated 2018 objectives, Novavax reached two important milestones in the second quarter for our lead ResVax™ and NanoFlu™ programs,” said Stanley C. Erck, Novavax President and CEO. “With ResVax, we achieved a critical enrollment goal in the Prepare™ trial, enabling us to reach agreement with the FDA to initiate a final efficacy analysis in the first quarter of 2019. This analysis will be used to support the future BLA and MAA in the U.S. and Europe, respectively.”

“On the NanoFlu front,” Mr. Erck continued, “the data published in The New England Journal of Medicine demonstrated that NanoFlu induced significantly improved immune response compared to the current leading high-dose influenza vaccine. We are on track to initiate a Phase 2 clinical trial of quadrivalent formulations of NanoFlu in the third quarter of this year. Pending successful Phase 2 data, based on discussions with the FDA, we anticipate initiating a Phase 3 immunogenicity clinical trial that may provide the basis of licensure via the FDA’s accelerated approval pathway.”

Operational Highlights:

ResVax ™ Program

  • In May 2018, Novavax’ Prepare trial reached enrollment of 4,636 pregnant women, at least 3,000 of whom received ResVax.
     
  • Novavax recently reached agreement with the FDA that the efficacy analysis to be conducted in the first quarter of 2019 will be the final analysis used to support the future biologics license application (BLA). This agreement was based on meeting the FDA’s minimum standards for evaluation of both the safety and efficacy of ResVax. We anticipate using the same data for filing a marketing authorization application (MAA) submission in Europe. The current and projected numbers of blinded primary endpoint cases provide Novavax with confidence that the trial is powered to make a statistically sound efficacy conclusion. Novavax expects to report on these data in the first quarter of 2019 and, assuming successful results, expects to submit the BLA and the MAA by the first quarter of 2020.

NanoFlu™ Program

  • In June 2018, The New England Journal of Medicine published a peer-reviewed letter to the editor detailing the positive results from Novavax’ Phase 1/2 clinical trial in older adults of NanoFlu compared to the leading licensed egg-based, high-dose influenza vaccine. Novavax had previously presented top-line results from this clinical trial at the World Vaccine Congress in April 2018.
     
  • In June 2018, the FDA acknowledged and agreed that the accelerated approval pathway for seasonal influenza vaccines could be available for NanoFlu.

Corporate

  • In April 2018, Novavax conducted a public offering of approximately 34.8 million shares of its common stock, resulting in net proceeds of $54 million.

Anticipated Events:

  • Final efficacy results of the Prepare trial are expected in the first quarter of 2019.
     
  • The Phase 2 clinical trial of quadrivalent formulations of NanoFlu is expected to begin in the third quarter of 2018.
     
  • Top-line data from the Phase 2 clinical trial of NanoFlu and End of Phase 2 meeting with the FDA are expected in the first quarter of 2019.

Financial Results for the Three and Six Months Ended June 30, 2018

Novavax reported a net loss of $44.5 million, or $0.12 per share, for the second quarter of 2018, compared to a net loss of $44.5 million, or $0.16 per share, for the second quarter of 2017. For the six months ended June 30, 2018, the net loss was $90.8 million, or $0.25 per share, compared to a net loss of $88.3 million, or $0.32 per share, for the same period in 2017.

Novavax revenue in the second quarter of 2018 was $10.8 million, compared to $6.7 million in the same period in 2017. This 60% increase was driven by higher revenue recorded under the Bill & Melinda Gates Foundation (BMGF) grant of $89 million as a result of increased enrollment in the Prepare trial and increased activities of Novavax AB, a wholly owned subsidiary of Novavax.

Research and development expenses increased 13% to $44.5 million in the second quarter of 2018, compared to $39.3 million for the same period in 2017. The increase was primarily due to increased development activities of ResVax.

General and administrative expenses decreased 8% to $8.2 million in the second quarter of 2018, compared to $8.9 million for the same period in 2017. The decrease was primarily due to lower employee-related costs.

Interest income (expense), net for the second quarter of 2018 was ($2.6) million, compared to ($3.0) million for the same period of 2017.

As of June 30, 2018, Novavax had $178.2 million in cash, cash equivalents, marketable securities and restricted cash, compared to $186.4 million as of December 31, 2017. Net cash used in operating activities for the second quarter of 2018 was $40.0 million, compared to $12.4 million for same period in 2017. The increase in cash usage was primarily due to the receipt of a $25 million payment under the BMGF grant in the six months ended June 30, 2017, whereas no payment was received in the same period of 2018 (however, we expect to receive a $15 million payment in the third quarter of 2018).

Conference Call

Novavax 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 5886748. A replay of the conference call will be available starting at 7:30 p.m. ET on August 8, 2018 until 7:30 pm ET on August 15, 2018. To access the replay by telephone, dial (855) 859-2056 (Domestic) or (404) 537-3406 (International) and use passcode 5886748.

A webcast of the conference call can also be accessed via a link on the home page of the Novavax website (novavax.com) or through the “Investor Info”/“Events” tab on the Novavax website. A replay of the webcast will be available on the Novavax website until November 8, 2018.

About RSV in infants

RSV (respiratory syncytial virus) is the leading viral cause of severe lower respiratory tract disease in infants and young children worldwide. Estimated annual infections of 64 million and an estimated 160,000 deaths make it the second leading cause of death in children under one year of age. RSV results in a total global economic burden of $6.2 billion annually. In the U.S., RSV is the leading cause of hospitalization of infants. While RSV can impact all infants, babies under six months of age are among those at highest risk, as approximately 77% of all first-year RSV infections occur before six months. In the U.S., the total economic burden is $2.7 billion annually.

About ResVax

ResVax is an RSV fusion (F) protein recombinant nanoparticle vaccine with aluminum phosphate. It is being developed to protect infants from RSV disease via maternal immunization and is the only RSV vaccine in a Phase 3 clinical trial for this indication. Protecting infants via maternal immunization has been shown to be effective against influenza, another respiratory virus, in prospective clinical studies. In addition, maternal immunization with tetanus and pertussis vaccines has been shown to be effective in preventing these diseases in infants. Maternal immunization may offer the best method of protection from RSV disease in infants through the first months of life.

Currently, ResVax is being evaluated in Prepare™, a global Phase 3 clinical trial in 4,636 pregnant women, at least 3,000 of whom have received the vaccine, and their infants. Prepare is supported by an $89.1 million grant from the Bill & Melinda Gates Foundation (BMGF).

About Influenza

Influenza is a world-wide infectious disease that causes illness in humans with symptoms ranging from mild to life-threatening or even death. Serious illness occurs not only in susceptible populations such as infants, young children and older adults, but also in the general population largely because of infection by continuously evolving strains of influenza which can evade the existing protective antibodies in humans. An estimated one million deaths globally each year are attributed to influenza.1  Current estimates for seasonal influenza vaccine growth in the top seven markets (U.S., Japan, France, Germany, Italy, Spain and UK), show a potential increase from approximately $3.2 billion in 2015 to $5.3 billion by 2025.2

About NanoFlu™ and Matrix-M™

NanoFlu is a recombinant hemagglutinin (HA) protein nanoparticle influenza vaccine produced by Novavax in its SF9 insect cell baculovirus system. NanoFlu uses HA amino acid protein sequences that are the same as the recommended wild-type circulating virus HA sequences. NanoFlu contains Novavax’ patented saponin-based Matrix-M adjuvant, which has demonstrated a potent and well-tolerated effect by stimulating the entry of antigen-presenting cells into the injection site and enhancing antigen presentation in local lymph nodes. Novavax expects to begin a Phase 2 for its quadrivalent NanoFlu clinical trial in the third quarter of 2018.

About Accelerated Approval

Accelerated approval may be granted for certain biological products that have been studied for their safety and effectiveness in treating serious or life-threatening illnesses and that provide meaningful therapeutic benefit over existing treatments.  Such an approval will be based on adequate and well-controlled clinical trials establishing that the biological product has an effect on a surrogate endpoint that is reasonably likely to predict clinical benefit.  For seasonal influenza vaccines, the hemagglutination inhibition (HAI) antibody response may be an acceptable surrogate marker of activity that is reasonably likely to predict clinical benefit.  To be considered for accelerated approval, a BLA for a new seasonal influenza vaccine should include results from one or more well-controlled studies designed to meet immunogenicity endpoints and a commitment to conduct confirmatory post-marketing studies of clinical effectiveness in preventing influenza.

About Novavax

Novavax, Inc. (Nasdaq:NVAX) is a late-stage biotechnology company that drives improved health globally through the discovery and development of innovative vaccines to prevent serious respiratory diseases. ResVax, its RSV vaccine for infants via maternal immunization, is the only vaccine in a Phase 3 clinical program and is poised to help prevent the second leading cause of death in children under one year of age worldwide. Novavax is also advancing the clinical study of our influenza nanoparticle vaccine, which addresses key factors that lead to poor efficacy by currently approved flu vaccines. Novavax is a leading innovator of recombinant vaccines; its proprietary recombinant technology platform combines the power and speed of genetic engineering to efficiently produce a new class of highly immunogenic particles addressing urgent global health needs.

For more information, visit www.novavax.com and connect with us on Twitter and LinkedIn.

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, 2017 and the Quarterly Report on Form 10-Q for the period ended June 30, 2018 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 sec.gov, 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.

NOVAVAX, INC.
CONDENSED CONSOLIDATED STATEMENTS OF OPERATIONS
(in thousands, except per share information)
(unaudited)
                   
      Three Months Ended   Six Months Ended
      June 30,   June 30,
        2018       2017       2018       2017  
                   
Revenue $   10,773     $   6,732     $   20,426     $   12,412  
                   
Expenses:              
  Research and development   44,542       39,263       89,056       76,916  
  General and administrative   8,224       8,940       16,876       17,793  
    Total expenses   52,766       48,203       105,932       94,709  
Loss from operations   (41,993 )     (41,471 )     (85,506 )     (82,297 )
Interest income (expense), net   (2,596 )     (2,993 )     (5,468 )     (6,032 )
Other income (expense)   97       (1 )     130       10  
Net loss $   (44,492 )   $   (44,465 )   $   (90,844 )   $   (88,319 )
                   
Basic and diluted net loss per share $   (0.12 )   $   (0.16 )   $   (0.25 )   $   (0.32 )
Basic and diluted weighted average              
  number of common shares outstanding   375,923       283,444       356,555       278,836  

SELECTED CONSOLIDATED BALANCE SHEET DATA
(in thousands)

  June 30,
2018
  December 31, 2017
  (unaudited)    
Cash and cash equivalents $   88,475     $   106,307  
Marketable securities     78,636         50,996  
Total restricted cash     11,084         29,124  
Total current assets     194,335         203,311  
Working capital     151,316         129,636  
Total assets     285,807         302,493  
Notes payable     318,475         317,763  
Total stockholders’ deficit     (87,707 )       (101,732 )
       


Contact:        

Investors
Novavax, Inc.
Erika Trahan
ir@novavax.com
240-268-2000

Westwicke Partners
John Woolford
john.woolford@westwicke.com
443-213-0506

Media
Sam Brown
Mike Beyer
mikebeyer@sambrown.com
312-961-2502


_____________________________

1 Resolution of the World Health Assembly (2003) WHA56.19.28

2 Influenza Vaccines Forecasts. Datamonitor (2013)

 

Om GlobeNewswire

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

https://globenewswire.com

GlobeNewswire is one of the world's largest newswire distribution networks, specializing in the delivery of corporate press releases financial disclosures and multimedia content to the media, investment community, individual investors and the general public.

Følg saker fra GlobeNewswire

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

Siste saker fra GlobeNewswire

WillScot Announces Appointment of General Counsel17.6.2019 22:29:00 CESTPressemelding

BALTIMORE, June 17, 2019 (GLOBE NEWSWIRE) -- WillScot Corporation (“WillScot”) (Nasdaq: WSC) today announced the appointment of Mr. Hezron Timothy Lopez to serve as the Company’s Vice President, General Counsel & Corporate Secretary, effective June 17, 2019. Mr. Lopez joins WillScot after having served from 2012 to 2018 as Senior Vice President, General Counsel and Corporate Secretary of Herman Miller, Inc., a Nasdaq-listed manufacturer of home and office furniture. From 2008 to 2012, Mr. Lopez served as Associate General Counsel and Head of Merger & Acquisition, Commercial and International for A. O. Smith Corporation, a manufacturer of water heating equipment and water treatment products. About WillScot Corporation Headquartered in Baltimore, Maryland, WillScot (Nasdaq: WSC) is the public holding company for the Williams Scotsman family of companies and is the specialty rental services market leader providing innovative modular space and portable storage solutions across North Americ

Cineworld Group and Cinionic Strike 1,000+ Unit Deal to Roll Out Acclaimed Barco Laser Projectors to Theaters Worldwide17.6.2019 18:05:00 CESTPressemelding

Cineworld embarks on global renewal with Cinionic, powered by award-winning projection portfolio and enhanced services KORTRIJK, Belgium, June 17, 2019 (GLOBE NEWSWIRE) -- Cinionic, the Barco, CGS, and ALPD cinema joint venture providing a new visual standard with enhanced services and technology solutions, announces a significant expansion in its relationship with one of the world’s largest theater chains, Cineworld Group plc (LON:CINE), to continue delivering an elevated movie-going experience for audiences worldwide. Cinionic will illuminate Cineworld Group operated theaters in the U.S., EU and UK with enhanced services and award-winning portfolio of Barco laser projectors, including the newly launched Barco Series 4. Over the next 18 months, Cineworld will upgrade and deploy over 1,000 projectors worldwide with Barco Laser solutions to deliver a new visual standard in cinema, supported by Barco Alchemy media servers and maintained for the next decade through Cinionic’s enhanced ser

Rock Tech Engages KBM Resources Group for LiDAR Survey at Georgia Lake17.6.2019 14:15:00 CESTPressemelding

VANCOUVER, British Columbia, June 17, 2019 (GLOBE NEWSWIRE) -- Rock Tech Lithium Inc. (the "Company" or “Rock Tech”) (TSX-V: RCK; Frankfurt: RJIB) is pleased to announce that it has engaged KBM Resources Group (“KBM”) to complete a LiDAR and high-resolution imagery survey at its 100%-owned Georgia Lake lithium project in Ontario, Canada. The aerial acquisition of LiDAR and digital photography will cover the Nama Creek main zone and adjacent areas of the Georgia Lake lithium project. The LiDAR survey, with a relatively high resolution of 10 laser points per square metre and an absolute accuracy of 10 cm vertical and 20 cm horizontal, will produce LAS files with classified ground points including a bare earth model and georeferenced orthoimagery. “The ideal time to fly this survey is after the snow melt and before leaf-out,” commented Martin Stephan, Rock Tech’s Chief Executive Officer. “These conditions, combined with a favourable regional weather forecast, shall make for a successful L

Carpenter Technology and Israel Aerospace Industries Announce Collaboration to Produce Commercial Aircraft Additive Parts17.6.2019 14:00:00 CESTPressemelding

Le Bourget, FRANCE, June 17, 2019 (GLOBE NEWSWIRE) -- Carpenter Technology Corporation (NYSE: CRS) and Israel Aerospace Industries (IAI) today announced their collaboration to produce additively manufactured components for a serial production commercial aircraft. This collaboration will result in IAI’s first metallic additively-produced parts, which are expected to provide significant manufacturing benefits and lay the groundwork for future design improvements and enhancements. IAI is working closely with Israel’s Civil Aviation Authority for approval of the parts, which when accomplished will represent the first time this technology has been approved for commercial use in Israel. Carpenter Technology, through its Carpenter Additive business unit, is producing the parts and providing supporting information to assist with their approval. “Together, Carpenter Additive and IAI are pioneering the use of this technology for new platforms and applications,” said Marshall Akins, Carpenter Tec

Major HAProxy Releases Increase Support for Cloud-Native and Containerized Application Architectures17.6.2019 14:00:00 CESTPressemelding

Key Community Releases Include HAProxy 2.0, HAProxy Data Plane API and HAProxy Kubernetes Ingress Controller WALTHAM, Mass., June 17, 2019 (GLOBE NEWSWIRE) -- HAProxy Technologies, provider of the world’s fastest and most widely-used software load balancer, today announced that the HAProxy community has released HAProxy 2.0 and several other key products that make it easier to extend, configure and manage HAProxy in cloud-native and containerized environments. The company also announced its inaugural community user conference, HAProxyConf 2019, which will take place in Amsterdam, Netherlands on November 12th and 13th, 2019. “The release of HAProxy 2.0 along with the new HAProxy Data Plane API and HAProxy Kubernetes Ingress Controller mark the culmination of a significant re-architecture of HAProxy to add the flexibility and features needed to optimize support for modern application architectures,” said Willy Tarreau, HAProxy community lead and HAProxy Technologies CTO. “I am extremely

Brookfield Asset Management Announces Results of Annual and Special Meeting of Shareholders17.6.2019 12:55:00 CESTPressemelding

BROOKFIELD, NEWS, June 17, 2019 (GLOBE NEWSWIRE) -- Brookfield Asset Management Inc. (TSX: BAM.A, NYSE: BAM, Euronext: BAMA) today announced that at the company’s annual and special meeting of shareholders held on June 14, 2019 in Toronto, over 85% of Class A Limited Voting Shares (“Class A Shares”) voted in favour of a new management share option plan. In addition, at the meeting all eight nominees proposed for election to the board of directors by holders of Class A Shares and all eight nominees proposed for election to the board of directors by the holder of Class B Limited Voting Shares (“Class B Shares”) were elected. Detailed results of the vote for the election of directors are set out below. Management received the following proxies from holders of Class A Shares in regard to the election of the eight directors nominated by this shareholder class: Director Nominee Votes For % Votes Withheld % M. Elyse Allan 731,503,129 99.60 2,926,448 0.40 Angela F. Braly 730,750,957 99.50 3,67