Novavax Reports Third Quarter 2017 Financial Results
GAITHERSBURG, Md., Nov. 07, 2017 (GLOBE NEWSWIRE) -- Novavax, Inc., (Nasdaq:NVAX) today announced its financial results for the third quarter and nine months ended September 30, 2017.
Third Quarter Achievements:
- Novavax initiated a Phase 1/2 clinical trial of its nanoparticle influenza vaccine candidate with its proprietary Matrix-M(TM) adjuvant (NanoFlu(TM)) in older adults. The trial is a randomized, observer-blinded, active comparator-controlled trial in approximately 330 healthy older adults. The primary objective of the trial is to assess the safety and immunogenicity of two antigen concentrations (15 µg or 60 µg) of NanoFlu compared to a licensed influenza vaccine, Fluzone® High-Dose (Fluzone HD).
- Novavax reported that NanoFlu demonstrated superior immunogenicity and protection compared to the market leader in a preclinical challenge study. In a head-to-head comparison study against Fluzone HD, NanoFlu demonstrated significantly stronger and broader immune responses against matched and unmatched influenza strains, including a series of "drifted" strains evolved over more than a decade of influenza seasons. NanoFlu was also protective in an established challenge model against both a matched and a ten-year old unmatched strain. Data from this study was published in the journal Vaccine.
- The Prepare(TM) clinical trial for infants via maternal immunization, supported by an $89 million grant from the Bill and Melinda Gates Foundation (BMGF), accelerated into the third global season of enrollment. Prepare's global footprint is expected to grow from 16 sites in five countries in its first season of enrollment to over 90 sites in 12 countries in 2018.
Anticipated 2017 Event:
- Announce topline data from a Phase 1/2 clinical trial of the NanoFlu vaccine candidate in a head-to-head comparison with Fluzone HD before the end of 2017.
"We were very pleased to initiate and fully enroll the Phase 1/2 clinical trial of our NanoFlu vaccine candidate in older adults, following impressive results in preclinical challenge models. Given this timing, we are well positioned to announce data from the ongoing trial before the end of the year," said Stanley C. Erck, President and CEO. "We also continue to make significant progress in our RSV F Vaccine program, highlighted by the continued execution of the Phase 3 Prepare trial for infants via maternal immunization. We are also evaluating plans to conduct a clinical trial for older adults in 2018."
Financial Results for the Three and Nine Months Ended September 30, 2017
Novavax reported a net loss of $44.6 million, or $0.15 per share, for the third quarter of 2017, compared to a net loss of $66.3 million, or $0.24 per share, for the third quarter of 2016. For the nine months ended September 30, 2017, the net loss was $132.9 million, or $0.47 per share, compared to a net loss of $222.9 million, or $0.82 per share, for the same period in 2016.
Novavax revenue in the third quarter of 2017 was $8.4 million, compared to $3.2 million in the same period in 2016. This 158% increase was driven by higher revenue recorded under the BMGF grant of $89 million.
Research and development expenses decreased 21% to $41.9 million in the third quarter of 2017, compared to $53.0 million for the same period in 2016. The decrease was primarily due to reduced activities related to the development of the RSV F Vaccine for older adults, other general R&D project-related expenses and lower employee-related costs.
General and administrative expenses decreased 40% to $8.1 million in the third quarter of 2017, compared to $13.6 million for the same period in 2016. The decrease was primarily due to lower professional fees for pre-commercialization activities and lower employee-related costs.
Interest income (expense), net for the third quarter of 2017 and 2016 was ($3.0) million.
As of September 30, 2017, the company had $172.6 million in cash, cash equivalents and marketable securities, compared to $235.5 million as of December 31, 2016. Net cash used in operating activities for the first nine months of 2017 was $106.6 million, compared to $194.2 million for the same period in 2016. The decrease in cash usage was primarily due to decreased costs relating to our RSV F Vaccine and lower overall employee-related costs.
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 2479419. A replay of the conference call will be available starting at 7:30 p.m. ET on November 7, 2017 until 7:30 pm ET on November 14, 2017. To access the replay by telephone, dial (855) 859-2056 (Domestic) or (404) 537-3406 (International) and use passcode 2479419.
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 through the "Investor Info"/"Events" tab on the Novavax website until February 7, 2018.
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, novavax.com.
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 Quarterly Report on Form 10-Q for the period ended September 30, 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 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.
|CONDENSED CONSOLIDATED STATEMENTS OF OPERATIONS|
|(in thousands, except per share information)|
|Three Months Ended||Nine Months Ended|
|September 30,||September 30,|
|Research and development||41,862||52,983||118,779||186,839|
|General and administrative||8,118||13,556||25,911||38,183|
|Loss from operations||(41,628||)||(63,308||)||(123,926||)||(215,068||)|
|Interest income (expense), net||(2,989||)||(2,957||)||(9,021||)||(7,756||)|
|Other income (expense)||10||11||20||(33||)|
|Basic and diluted net loss per share||$||(0.15||)||$||(0.24||)||$||(0.47||)||$||(0.82||)|
|Basic and diluted weighted average number of common shares outstanding||296,435||271,064||284,767||270,669|
SELECTED CONSOLIDATED BALANCE SHEET DATA
|Cash and cash equivalents||$||104,245||$||144,353|
|Total current assets||225,995||287,830|
|Total notes payable and capital lease obligation||317,407||316,376|
|Total stockholders' deficit||(74,151||)||(5,546||)|
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
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
GaN Systems to Showcase Innovative GaN Power Technologies and Customer Solutions at PCIM Europe 201823.5.2018 15:00 | Pressemelding
Record-setting GaN transistors and an array of new products, design tools, and reference designs that make it easier to develop ground-breaking power systems will be displayed OTTAWA, May 23, 2018 (GLOBE NEWSWIRE) -- GaN Systems, the global leader in GaN (gallium nitride) power semiconductors, today announced that it will be exhibiting the company's new products and design tools and presenting customer demonstrations at PCIM Europe 2018 (Power Conversion and Intelligent Motion), Booth 511 in Hall 9 (9-511) from June 5-6, 2018 in Nuremberg, Germany. At PCIM Europe, one of the leading exhibitions for power electronics and its applications, attendees to the GaN Systems booth will learn about new products, the numerous IC companies that have collaborated with GaN Systems, and a vast array of customer implementations spanning the consumer, data center, industrial, and automotive market segments. Also, GaN Systems' subject matter experts will be speaking at four sessions over the course of t
Addiko Bank Implements Digital Banking Solutions on Appian23.5.2018 13:30 | Pressemelding
Digital Lending and Trade Finance applications cut customer wait times in half RESTON, Va., BELGRADE, Serbia and LJUBLJANA, Slovenia, May 23, 2018 (GLOBE NEWSWIRE) -- Appian (Nasdaq:APPN) and Addiko Bank, an international financial group headquartered in Vienna, Austria, today announced that the bank has deployed two new digital banking applications on Appian's low code application platform. The applications cover Lending and Trade Finance processes across Addiko's Corporate and Small Medium Enterprise (SME) customers. The applications have reduced customer wait times by as much as 50% by cutting "time to yes" for simple loans down from one week to just three days. Addiko Bank is the only financial group primarily focused on markets in the South Eastern Europe region (SEE), servicing more than 1 million customers. With these Appian deployments, Addiko Bank is the first bank within the SEE region to provide such a digital banking platform to customers in Slovenia and Serbia. Addiko is a
GMO Internet Group Offers GMO miner, The World's First Mining Machine Equipped with Mining Chips Using a Cutting-Edge 7 nm Process Technology: information session on Wednesday, June 623.5.2018 13:03 | Pressemelding
TOKYO, May 23, 2018 (GLOBE NEWSWIRE) -- Tokyo, Japan - May 23, 2018 - GMO Internet Group (https://www.gmo.jp/en/ ) will launch GMO miner (product name: GMO miner B2), which is our own high-performance computer for mining (mining machine), on Wednesday, June 6, 2018. We will mass-produce the world's first mining machine equipped with a cutting-edge 7 nm* process based semiconductor chip (7 nm mining chip; "GMO 72b"), which will be shipped at the end of October 2018. As a result, an information session for potential customers considering the purchase of GMO miner will be held on Wednesday, June 6 in Shibuya, Tokyo, and we will explain the details of GMO miner, such as price and performance. *nm: nanometer. 1/1 billion meters. 1/1 million millimeters. Selling "GMO miner" Cryptocurrency mining requires high-performance mining machines enabling highly sophisticated and intensive computation. Accordingly, GMO Internet Group has been working on research and development of a cutting-edge 7 nm
SolarWinds Extends Network Management Software Leadership with Deeper Visibility and Smarter Scalability23.5.2018 12:30 | Pressemelding
Software now simplifies management of complex networks with Network Insight for Cisco Nexus and intelligent mapping, supporting environments four times larger than previous generation AUSTIN, Texas, May 23, 2018 (GLOBE NEWSWIRE) -- SolarWinds, the worldwide leader in network management software, today announced a wave of updates to its network management product portfolio, which can now support networks up to four times larger than the previous generation. This significant gain makes it easy to consolidate monitoring solutions to a single provider enterprise-wise, and gives IT professionals far greater flexibility to scale up and support larger data center networks as workloads increase, or scale out to address complex distributed networks. SolarWinds says the broad refresh of its network management portfolio strengthens its IDC®-validated network management leadership position.1 Updated versions of Network Performance Monitor (NPM), Network Configuration Manager (NCM), IP Address Mana
VITEC to Showcase High-Quality, Low-Bandwidth Tactical Video Solutions at Eurosatory 201823.5.2018 10:00 | Pressemelding
VITEC Boosts Its ISR and Homeland Security Video Streaming and Dissemination Solutions With the World's Smallest Quad-Channel Rugged HEVC Encoder and a New Military-Grade IPTV Portal PARIS, May 23, 2018 (GLOBE NEWSWIRE) -- VITEC, a worldwide leader in advanced video encoding and streaming solutions, today announced it will showcase its latest high-performance video streaming solutions for military and defense applications at Eurosatory 2018. Scheduled for June 11-15 at Paris Nord Villepinte, Eurosatory is the premier international defense and security exhibition. "VITEC is strongly committed to providing every capability for processing and distributing Intelligence, Surveillance, and Reconnaissance (ISR) and situational awareness video generated in the field," said Richard Bernard, product manager, VITEC. "As a result of that commitment, we've added MGW Diamond TOUGH to our encoder lineup. The multichannel encoder streams up to eight video channels with extremely low bandwidth and low
DealCloud announces global expansion, opening of EMEA Headquarters23.5.2018 08:00 | Pressemelding
LONDON, May 23, 2018 (GLOBE NEWSWIRE) -- DealCloud, a technology leader for deal & relationship management in the private capital markets, announces the opening of its EMEA headquarters in Holborn, London, United Kingdom. With the opening of the regional headquarters in London, DealCloud operates out of 4 offices globally. Supporting a rapidly growing client base in the region, DealCloud now provides implementation services, client support, and account management through a dedicated team based out of the London office. "We work closely with every client to tailor our exceptional technology and capabilities to their specific process," says DealCloud Co-Founder and Chief Revenue Officer Ben Harrison. "We are committed to delivering the best possible results for our clients, and we believe growing our team in London is the best way to do this." "Supporting dozens of clients in EMEA today, and adding new clients every week, we are excited about the impact our office expansion will have wit
I vårt presserom finner du alle våre siste saker, kontaktpersoner, bilder, dokumenter og annen relevant informasjon om oss.Besøk vårt presserom