Nasdaq GlobeNewswire

Novavax Reports First Quarter 2018 Financial Results

Del

GAITHERSBURG, Md., May 09, 2018 (GLOBE NEWSWIRE) -- Novavax, Inc., (Nasdaq:NVAX) today announced its financial results for the first quarter ended March 31, 2018.

First Quarter and Subsequent Achievements:

RSV F Vaccine

  • In May 2018, Novavax reached enrollment of approximately 4,600 pregnant women in its Prepare(TM) Phase 3 clinical trial of its RSV F Vaccine for infants via maternal immunization. This milestone enables Novavax to initiate a prespecified interim efficacy analysis after approximately six months of follow-up of the last infant born to the approximately 4,600 women enrolled (including 3,000 actively vaccinated women). Completion of this analysis is expected in the first quarter of 2019. Since 2015, the Prepare trial is supported by an $89 million grant from the Bill & Melinda Gates Foundation (BMGF).
     
  • In April 2018, Novavax presented at the World Vaccine Congress on the status of its Phase 3 clinical trial of its RSV F Vaccine.

NanoFlu(TM)

  • In April 2018, Novavax presented clinical data at the World Vaccine Congress from the Phase 1/2 clinical trial in older adults comparing trivalent formulations of NanoFlu to the market-leading licensed egg-based, high-dose influenza vaccine for older adults.
     
  • In February 2018, Novavax reported positive top-line results from its Phase 1/2 clinical trial of its trivalent NanoFlu.

Corporate

  • In April 2018, Novavax completed an underwritten public offering of approximately 34.8 million shares of its common stock, including 4.5 million shares pursuant to the underwriters' option to purchase additional shares. The shares resulted in net proceeds of $54 million.
     
  • Effective on March 14, 2018, John J. Trizzino, former Senior Vice President, Commercial Operations since 2014, was promoted to Senior Vice President, Chief Business Officer and Chief Financial Officer.

Anticipated Events:

  • Initiation of the Phase 2 clinical trial of quadrivalent formulations of NanoFlu scheduled to begin in the third quarter of 2018.
     
  • Top-line data from the Phase 2 NanoFlu trial and End of Phase 2 meeting with the FDA expected in the first quarter of 2019.
     
  • Results of the Prepare Phase 3 interim efficacy analysis for our RSV F Vaccine expected in the first quarter of 2019.  

Summary

"We had an extremely productive first quarter, including making important advances in our two lead clinical vaccine programs. We are pleased to have reached the enrollment target for our Prepare Phase 3 RSV F Vaccine trial, which clears the path for following these most recent participants and their babies, and subsequently announcing top-line results of our planned interim efficacy analysis in the first quarter of 2019," said Stanley C. Erck, President and CEO of Novavax, Inc. "We also continue to make significant progress on NanoFlu and plan to initiate a Phase 2 clinical trial in the third quarter of 2018."

Financial Results for the First Quarter Ended March 31, 2018

Novavax reported a net loss of $46.4 million, or $0.14 per share, for the first quarter of 2018, compared to a net loss of $43.9 million, or $0.16 per share, for the first quarter of 2017.

Novavax revenue in the first quarter of 2018 was $9.7 million, compared to $5.7 million in the same period in 2017. This 70% increase was driven by higher revenue recorded under the BMGF grant corresponding to the increased enrollment in the Prepare trial.

Research and development expenses increased 18% to $44.5 million in the first quarter of 2018, compared to $37.7 million for the same period in 2017. The increase was primarily due to increased development activities of the RSV F Vaccine for infants via maternal immunization.

Interest income (expense), net for the first quarter of 2018 was ($2.9) million, compared to ($3.0) million for the same period of 2017.

As of March 31, 2018, Novavax had $164.2 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 first quarter of 2018 was $66.1 million, compared to $44.5 million for same period in 2017. The increase in cash usage was primarily due to approximately $16 million of one-time payments, as well as the adoption of a new accounting standard that requires restricted cash to be included in the beginning and ending balances on the statements of cash flows, thus increasing Novavax' cash usage in the first quarter of 2018 and 2017 by approximately $9 million and $6 million, respectively. We expect our cash used in operating activities to significantly decrease for the subsequent quarters of 2018 as compared to the first quarter of 2018.

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 3687883. A replay of the conference call will be available starting at 7:30 p.m. ET on May 9, 2018 until 7:30 p.m. ET on May 16, 2018. To access the replay by telephone, dial (855) 859-2056 (Domestic) or (404) 537-3406 (International) and use passcode 3687883.

A webcast of the conference call can also be accessed via a link on the home page of the Novavax website at www.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 August 9, 2018.

About RSV

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.2 Despite the induction of post-infection immunity, repeat infection and lifelong susceptibility to RSV is common.3 Currently, there is no approved RSV vaccine available.

About RSV F Vaccine for Infants via Maternal Immunization

Novavax is developing a vaccine that targets the fusion protein, or F protein, of the RSV virus. The F protein has highly conserved amino acid sequences, called antigenic sites, which are the target of neutralizing antibodies and are believed to be ideal vaccine targets. Novavax' genetically engineered novel F protein antigen exposes a range of these antigenic sites, and can evoke immune responses to them in human vaccine recipients. In a previous Phase 2 clinical trial of the RSV F Vaccine, which assessed the transplacental transfer of maternal antibodies induced by the vaccine, immunized women demonstrated meaningful fold rises in anti-F IgG, palivizumab-competing antibodies and microneutralization titers. In addition, infants' antibody levels at delivery averaged 90-100% of the mothers' levels, indicating efficient transplacental transfer of antibodies from mother to infant.

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 each year are attributed to influenza.4 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 2025.5

About NanoFlu(TM)

NanoFlu is a recombinant hemagglutinin (HA) protein nanoparticle influenza vaccine candidate 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.

About Novavax

Novavax, Inc. (Nasdaq:NVAX) is a clinical-stage biotechnology company committed to delivering novel products to prevent infectious diseases. Its RSV and influenza nanoparticle vaccine candidates are Novavax' most advanced clinical programs and are at the forefront of Novavax' efforts to improve global health. For more information, please visit www.novavax.com.

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 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.

1 https://www.niaid.nih.gov/diseases-conditions/respiratory-syncytial-virus-rsv

2 Leader S. Pediatr Infect Dis J. 2002 Jul;21(7):629-32

3 PLOS. "How immunity to respiratory syncytial virus develops in childhood, deteriorates in adults." ScienceDaily. 21 April 2016. https://www.sciencedaily.com/releases/2016/04/160421145747.htm

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

5 Influenza Vaccines Forecasts. Datamonitor (2013)

 
 
NOVAVAX, INC.
CONDENSED CONSOLIDATED STATEMENTS OF OPERATIONS
(in thousands, except per share information)
(unaudited)
                   
          Three Months Ended
          March 31,
                2018       2017  
                   
Revenue         $      9,653     $   5,680  
                   
Expenses:              
  Research and development           44,514       37,654  
  General and administrative           8,652       8,852  
    Total expenses           53,166       46,506  
Loss from operations           (43,513 )     (40,826 )
Interest income (expense), net           (2,872 )     (3,039 )
Other income (expense)           33       11  
Net loss         $      (46,352 )   $   (43,854 )
                   
Basic and diluted net loss per share         $      (0.14 )   $   (0.16 )
Basic and diluted weighted average              
  number of common shares outstanding           336,972       274,178  
                   

 

 
SELECTED CONSOLIDATED BALANCE SHEET DATA
(in thousands)
 
  March 31,  
2018
  December 31,
2017
  (unaudited)    
Cash and cash equivalents $   113,402     $   106,307  
Marketable securities     30,358         50,996  
Total restricted cash     20,439         29,124  
Total current assets     181,034         203,311  
Working capital     136,130         129,636  
Total assets     276,067         302,493  
Notes payable     318,119         317,763  
Total stockholders' deficit     (99,369 )       (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




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 8700http://www.nasdaqomx.com

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

Sonos Announces Date for Fiscal Third Quarter 2018 Earnings Conference Call20.8.2018 22:14Pressemelding

SANTA BARBARA, Calif., Aug. 20, 2018 (GLOBE NEWSWIRE) -- Sonos, Inc. (“Sonos”) (Nasdaq: SONO) today announced that after market close on Monday, September 10, 2018, the company will report financial results for the fiscal third quarter ended June 30, 2018 in a letter to shareholders, which will be made available on the investor relations section of its website. In addition, the company will host a conference call and Q&A to discuss the results on the same day at 5:00 p.m. Eastern Time. A live webcast and replay of the conference call and Q&A will be accessible at: https://investors.sonos.com/news-and-events/default.aspx. The replay will be available for at least one year following completion of the call. The conference call may also be accessed by dialing (866) 393-4306, with conference ID 6098946. Participants outside the U.S. can dial toll-free (734) 385-2616. About Sonos Sonos is the leading multi-room wireless smart home sound system. As the inventor of multi-room wireless home aud

SEMAFO Updates on Security in Burkina Faso20.8.2018 16:29Pressemelding

MONTREAL, Aug. 20, 2018 (GLOBE NEWSWIRE) -- SEMAFO Inc. (TSX, OMX: SMF) announces an update on its security measures in Burkina Faso following two armed incidents last week. The Mana and Boungou Mines continue to operate without interruption. Boungou Mine The transport of personnel and supplies has resumed between the Boungou Mine and Ouagadougou under our adjusted security protocol. All expatriate employees are now being transported by helicopter between the two locations. In addition, a ground military force has been deployed on the route between the mine and the capital city. These measures, combined with a heightened escort presence, will ensure transportation of national employees to and from the mine to their villages. Mana Mine Further investigation into Friday’s incident revealed that our employee bus had the misfortune of driving into an ongoing hold-up by bandits on the main Bobo road. This led to an exchange of gunfire, as previously reported. As part of our new security mea

CamundaCon 2018 to Feature Speakers from Goldman Sachs, 24 Hour Fitness, Universal Music and Vodafone20.8.2018 14:00Pressemelding

CamundaCon Will Convene 400+ Software Architects, IT Managers and DevOps Professionals to Discuss Workflow Automation Challenges in the Age of Containers and Microservices BERLIN, Aug. 20, 2018 (GLOBE NEWSWIRE) -- Camunda today announced the agenda for CamundaCon, the preeminent conference focused on new innovation in workflow automation for digital businesses. The two-day conference will feature twenty three sessions across two tracks and will take place September 20-21, 2018, at Radialsystem Berlin. Hundreds of participants will gather to discuss the rise of microservices and event-driven architectures in business process management (BPM), and the key role workflow automation is playing in digital transformation. To see full agenda or to register to attend, please visit https://camunda.com/events/camundacon/. The workflow automation market is expected to reach nearly $17 billion by 2023, up from $4.7 billion in 2017.1 As companies across industries accelerate their digital transforma

Ondot’s Mobile Card Controls Provide Protection to Thousands of Banks from ATM Heist Threat17.8.2018 22:47Pressemelding

-Card controls counter threat of FBI’s warning on unlimited ATM cash out crime - Santa Clara, Calif., Aug. 17, 2018 (GLOBE NEWSWIRE) -- US mainstream media is reporting on a FBI warning to banks of an impending cybercrime wave targeting ATMs in which thieves seek to steal millions of dollars by using cloned cards for fraudulent withdrawals. Ondot, the global leader in mobile payments services, provides consumers a simple protection with mobile-based card controls that can restrict ATM transactions without completely shutting off the card for legitimate needs. Ondot’s mobile controls can give consumers the ability to restrict transactions specifically for ATMs while leaving their cards active for in-person purchases, eCommerce, and other purchases. By locking the account’s use at an ATM, consumers can work with their financial institution to ensure other security best practices are in place while knowing that even a spoofed card will be unable to withdraw cash. If emergency cash is need

SEMAFO: Armed Incident in Bobo Area17.8.2018 15:48Pressemelding

MONTREAL, Aug. 17, 2018 (GLOBE NEWSWIRE) -- SEMAFO Inc. (TSX:SMF) (OMX:SMF) regrets to report that a bus transporting employees from the town of Bobo-Dioulasso to the Mana Mine in Burkina Faso was shot at by armed bandits this morning. In the exchange of fire between the policemen and bandits, one SEMAFO national employee and one sub-contractor employee lost their lives. Operations at the Mana Mine, located 80 kilometers from the incident, are not affected. Early analysis suggests that this incident and the armed incident that occurred in the Est region six days ago are unrelated. However, the Corporation will be increasing its security measures at Mana and take appropriate steps to ensure the safety of the mine and of its employees. The Corporation would like to express its sincere sympathy to families of the victims. About SEMAFO SEMAFO is a Canadian-based mining company with gold production and exploration activities in West Africa. The Corporation operates the Mana Mine in Burkina

ThalesNano Energy Introduces H-Genie™: Revolutionary Compact, High Pressure Hydrogen Gas Generation Platform for Chemists17.8.2018 11:00Pressemelding

Improves safety, expands chemistry, saves lives. BUDAPEST, Hungary and BOSTON, Aug. 17, 2018 (GLOBE NEWSWIRE) -- ThalesNano Energy LLC today announced, at the 256th ACS conference (booth: 1615), the launch of the first in the series of revolutionary new gas generators, the H-Genie™. The H-Genie™ is a compact high pressure hydrogen generator designed to be used in any laboratory as a safer and simpler alternative to hydrogen cylinders. Capable of generating hydrogen at up to 1 NL/min and 100 bar (1450 psi), the system can help expand chemists’ limited hydrogenation chemistry capability by providing high purity hydrogen gas, on demand from water, to batch and flow reactors. Neal Langerman, Principal Scientist at Advanced Chemical Safety, comments: “The presence of cylinders of hydrogen raises the risk level of a lab. While the explosion or fire hazard can be mitigated with a gas cylinder cabinet, this takes precious floor space and does not eliminate the 1300 liters of flammable gas from

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

Besøk vårt presserom