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

Infovista Expands 5G Network Testing and Planning Capabilities20.2.2019 15:00:00Pressemelding

ASHBURN, Va., Feb. 20, 2019 (GLOBE NEWSWIRE) -- Infovista, the leader in modern network performance, today announced new versions of its TEMS Investigation and Planet solutions. With this announcement, Infovista is the only vendor offering the complete 5G portfolio comprising full network planning and testing in a single, integrated platform. Infovista is now uniquely positioned to help mobile network operators roll out 5G NR networks by including the ability to provide integrated Geodata, 5G Planning and Network Testing capabilities. Tweet This: @Infovista expands 5G network testing and planning capabilities, offering complete 5G portfolio in a single, integrated platform: https://bit.ly/2Nm8Rup With the new release of TEMS Investigation, Infovista introduces support for 5G smartphones based on the Qualcomm X50 chipset. With initial support of Qualcomm based devices and plans for agnostic device support, customers will be able to choose between different test devices and scanners to s

Reminder: Constellation Brands to Present at Consumer Analyst Group of New York Conference, February 20, 201920.2.2019 14:30:00Pressemelding

VICTOR, N.Y., Feb. 20, 2019 (GLOBE NEWSWIRE) -- Constellation Brands, Inc. (NYSE: STZ and STZ.B), a leading beverage alcohol company, reiterates that Bill Newlands, president and chief operating officer, and David Klein, chief financial officer, will present at the Consumer Analyst Group of New York (CAGNY) conference on Wednesday, February 20, 2019, at the Boca Raton Resort & Club in Florida. The presentation is scheduled to begin at 3:00 p.m. EST and is expected to cover the company’s strategic business activities, including a discussion on portfolio strategy; financial and operational performance; and outlook for the future, including a discussion on the accounting methodology and potential impact on fourth quarter fiscal year 2019 non-cash equity in earnings from the company’s Canopy Growth investment. A live audio webcast of the presentation can be accessed on the company’s website at www.cbrands.com by following the instructions in the “Investors” section under “Events & Presenta

Fortuna provides construction update at its Lindero gold project in Argentina20.2.2019 11:00:00Pressemelding

VANCOUVER, British Columbia, Feb. 20, 2019 (GLOBE NEWSWIRE) -- Fortuna Silver Mines Inc. (NYSE: FSM) (TSX: FVI) is pleased to provide an update on construction activities at its 100 percent owned Lindero gold Project located in the Province of Salta, Argentina. Following the cessation of unusually heavy rainfall in Salta Province in recent weeks, which resulted in damage to the road leading to the Lindero Project site (see Fortuna news release dated February 7, 2019), management is pleased to report that the road has been repaired and on February 18th the mobilization of personnel and materials to the project site resumed. Mr. Jorge A. Ganoza, President, CEO and Director, commented, “Abnormal rains and electrical thunder storms not seen in a decade in the region are impacting our construction activities and schedule projections. A large amount of the float in the construction schedule has been consumed due to a slow start and ramp-up in excavations at the leach pad and crushing plant,

DoubleVerify Acquires Digital Video Technology Company, Zentrick20.2.2019 09:00:00Pressemelding

Solving 30% breakage in video ad delivery NEW YORK and GHENT, Belgium, Feb. 20, 2019 (GLOBE NEWSWIRE) -- DoubleVerify, the leading independent provider of marketing measurement software and analytics, today announced that it has acquired Zentrick, a digital video technology company that provides middleware solutions to drive the seamless execution and performance of online video advertising for the world’s largest brands, platforms and publishers. The Zentrick engineering teams will continue to operate from offices in Ghent, Belgium. The transaction was completed as an all cash, all stock offer on February 15, 2019. Video advertising spend soared to $28 Billion in 2018. However, the ecosystem necessary to support the growth in video ad delivery has become highly fragmented. Today over 30% of video ads that are sold are unable to be delivered by publishers due to various forms of technical ‘breakage’ in the ad delivery chain – an issue that’s particularly acute in the key areas of mobil

ADC Therapeutics Announces First Patient Dosed in Phase I Clinical Trial of ADCT-402 (loncastuximab tesirine) and Ibrutinib in Patients with Advanced Diffuse Large B-Cell Lymphoma or Mantle Cell Lymphoma20.2.2019 07:00:00Pressemelding

Combination trial to evaluate safety and anti-tumor activity of agents that target B-cell cancers LAUSANNE, Switzerland, Feb. 20, 2019 (GLOBE NEWSWIRE) -- ADC Therapeutics, an oncology drug discovery and development company that specializes in the development of proprietary antibody drug conjugates (ADCs), today announced that the first patient has been dosed in a Phase I clinical trial evaluating the safety, tolerability, pharmacokinetics and anti-tumor activity of ADCT-402 (loncastuximab tesirine) in combination with Pharmacyclics LLC’s ibrutinib in patients with advanced diffuse large B-cell lymphoma (DLBCL) or mantle cell lymphoma (MCL). ADCT-402, an ADC designed to target and kill CD19-expressing malignant B-cells, is also being evaluated in an ongoing pivotal Phase II clinical trial in patients with relapsed or refractory (R/R) DLBCL and a Phase I clinical trial in combination with IMFINZI® (durvalumab) in patients with multiple types of R/R non-Hodgkin lymphoma. Ibrutinib, a sma

RedAwning Opens Up New Office in Palma de Mallorca, Spain To Offer Industry-Leading Distribution, Marketing + Reservations Services to European Property Managers20.2.2019 02:30:00Pressemelding

New Jetstream Team Office To Support RedAwning Group’s Expansion in Europe and Provide Comprehensive Support For International Clients Emeryville, California, Feb. 19, 2019 (GLOBE NEWSWIRE) -- RedAwning, the world’s largest collection of vacation properties, today announced that it has opened up an office in ParcBit, Palma de Mallorca, Spain to service the RedAwning Group’s growing portfolio of international vacation property managers and to offer RedAwning’s industry-leading distribution, marketing and reservation solutions to managers of alternative accommodations throughout Europe. RedAwning is a single point of entry for managers of single vacation homes and multi-unit boutique hotels, resorts, apart-hotels and corporate apartments to access the widest online travel network in the world, including Booking.com, Expedia, Airbnb, and HomeAway/VRBO, as well as a major travel metasearch sites including trivago, Holidu, HomeToGo and TripAdvisor. RedAwning is also integrated with Google H