dothedd
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Joined: Dec 27, 2010 20:43:28 GMT -5
Posts: 2,683
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NOVAVAX
Sept 17, 2013 19:49:30 GMT -5
Post by dothedd on Sept 17, 2013 19:49:30 GMT -5
Novavax to Host an Analyst and Investor Update Call With Webcast
ROCKVILLE, Md., Sept. 17, 2013 (GLOBE NEWSWIRE) -- Novavax, Inc. (NVAX), a clinical-stage biopharmaceutical company creating novel recombinant nanoparticle vaccines and vaccine adjuvants, today announced that it will host the Analyst and Investor Update Call with Webcast on Tuesday, September 24, 2013, from 9:00 a.m. - 11:00 a.m. (EDT).
Senior management, including Stanley Erck, President and Chief Executive Officer; Gregory Glenn, MD, SVP and Chief Medical Officer; Lou Fries, MD, VP of Clinical & Medical Affairs; and Gale Smith, PhD, VP of Vaccine Development, along with special guest speaker Dr. Pedro A. Piedra, Professor of Molecular Virology and Microbiology at the Baylor College of Medicine, and a key-opinion leader in the field of pediatric infectious diseases and viral respiratory illnesses, will present on the following topics:
Corporate Overview Recombinant Nanoparticle Technology: an Engine for Growth The Novavax Influenza Programs The RSV Landscape The Novavax RSV Programs "Novavax is excited about the opportunity to update the investor community on the development plans for our lead candidates," said Stan Erck, President and CEO. "This meeting allows us to set the stage for 2014 development and to provide some visibility into 2015."
The dial-in number for the conference call is 1 (877) 212-6076 (U.S. or Canada) or 1 (707) 287-9331 (international). The webcast can 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 call will be available starting at 1:00 pm on Tuesday, September 24, 2013 until midnight November 5, 2013. To access the replay by telephone, dial 1 (855) 859-2056 (U.S. or Canada) or 1 (404) 537-3406 (international) and use passcode 65051892. The replay will also be available as a webcast and can be found on the "Investor Info"/ "Events" on the Novavax website.
About Novavax
Novavax, Inc. (NVAX) is a clinical-stage biopharmaceutical company creating novel vaccines and vaccine adjuvants to address a broad range of infectious diseases worldwide. Using innovative proprietary recombinant protein nanoparticle vaccine technology, the company produces vaccine candidates to efficiently and effectively respond to both known and newly emergent diseases. Novavax is involved in several international partnerships, including collaborations with Cadila Pharmaceuticals of India, LG Life Sciences of Korea and PATH, and recently acquired Isconova AB, a leading vaccine adjuvant company located in Sweden. Together, Novavax' network supports its global commercialization strategy to create real and lasting change in the biopharmaceutical and vaccinology fields. Additional information about Novavax is available on the company's website, novavax.com.
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dothedd
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Post by dothedd on Sept 17, 2013 23:40:15 GMT -5
It is about time!
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dothedd
Senior Member
Joined: Dec 27, 2010 20:43:28 GMT -5
Posts: 2,683
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NOVAVAX
Sept 18, 2013 1:19:32 GMT -5
Post by dothedd on Sept 18, 2013 1:19:32 GMT -5
An Alternative to the Scale-up and Distribution of Pandemic Influenza Vaccine
With baculovirus-based production in disposable equipment, vaccine can be available 10 to 12 weeks after an outbreak.
Jan 2, 2009 By: James M. Robinson BioPharm International Supplements Abstract
An influenza pandemic is a global health risk and many solutions are being developed to attempt to address this serious threat. Vaccination is thought to be a preferred solution, although access to a timely and sufficient supply of vaccine against a new emerging pandemic strain is inadequate in every country around the world. A new approach makes it possible to provide vaccine within 10 to 12 weeks of identification of a new viral strain, with an exact match to the wild-type influenza strain, by using disposables-based manufacturing facilities that can be built more quickly and cheaply than traditional vaccines plants.
The Current State of Preparedness
Virus-like particles (VLPs) mimic a natural virus in size, structure and surface proteins, but do not have the nuclear material necessary for infection. They trigger an immune response as if a natural infection takes place. (Novavax, Inc.) The threat of an influenza pandemic is well recognized. Many thought leaders in the field believe it is a matter of when, not if, a pandemic event will occur. The threat has triggered emergency preparedness efforts in many developed countries and the result has been the purchase of multiple medical countermeasures including stockpiles of medical supplies (e.g., masks, gloves), antiviral drugs (e.g., Tamiflu), and the development and stockpiling of vaccines against multiple prepandemic strains of the H5N1 influenza virus (e.g., A/Vietnam, A/Indonesia, A/Anhui). Because the total supply and cross-reactivity of these stockpiled vaccines is insufficient for mass immunization, adjuvants are also stockpiled, to stretch the available antigen supply and to improve the cross-reactivity of the vaccines we can make today.
As a result of this government-sponsored procurement and development of these medical countermeasures, there is clearly an improved state of preparedness today in some specific countries, particularly the US. However, vulnerabilities remain even in the best-prepared countries, and the majority of the global population remains unprotected. No country has a supply of vaccine for a novel influenza strain (e.g., H2, H7, H9), as the focus of development efforts to date has been on various strains of H5N1. No country has a sufficient supply of vaccine without adjuvants, and the adjuvants have not been proven safe in large-scale clinical studies. Most countries do not have influenza manufacturing capabilities within their national borders, and because borders will close on the declaration of a pandemic to control the spread of disease, vaccine distribution will also be hindered. In addition, it will be politically difficult to ship precious vaccine out of a country until all citizens are protected. In the end, most countries would be left without a supply of pandemic vaccine.
The Challenges of Ensuring Sufficient Supply
Today, the vast majority of influenza vaccines are made by growing the target influenza virus in fertile chicken eggs. The eggs are infected with the virus, the virus is allowed to grow for several days, and then the virus is removed from the egg, purified, inactivated, and treated with detergent to remove most egg and influenza proteins other than the hemagglutinin (HA) protein. (Antibody to HA from immunization will neutralize a similar virus on infection and is thereby correlated with protection from disease risk).
Newer methods are being developed to replace the chicken egg with a cell line developed from various mammalian species, although the purification and inactivation are managed in a similar manner.
The cost of developing new vaccine production capacity by traditional means is prohibitively expensive. New facilities in the US have been reported to cost $150 million for large-scale egg-based (100 million doses/season) and to $600 million for mammalian cell–based (50 million doses/season) facilities. These high costs have resulted in large centralized facilities in developed countries where the market value is high, with excess supply being exported to other markets.
In addition, the capacity needed for a rapid and complete pandemic response is far greater than the seasonal influenza vaccine demand. Building capacity for the pandemic need would result in overcapacity for seasonal needs. Such new capacity would be severely under-utilized, or the market for seasonal vaccine would be overserved, lowering prices and margins and hence diminishing the financial returns required to build and maintain the operational infrastructure for manufacturing under current good manufacturing practices (CGMPs). This may already be the case in the US, where new facility projects (e.g., Solvay's cell culture plant) are being shelved because of poor economics, even with government cost-sharing for new facilities.
Many governments are aware of these problems and the need to create supply within their borders. However, the initial high capital requirements for traditional approaches have left them with a list of expensive alternatives that are difficult to justify given the uncertainty of the pandemic need. Likewise, a facility built to react to a pandemic event would only be effective if it were in a constant state of readiness for production, because equipment needs to be exercised and maintained, and people must be trained. This state of readiness can be accomplished only by making other products in the facility and then switching to pandemic flu vaccine production when needed. The best fit would be seasonal influenza production for the local market, but this has important implications for global influenza vaccine oversupply, competition, and the utilization of capital, as the facility would likely not be well suited for other vaccines made by traditional means.
An Alternative Approach: Baculovirus Production in Disposable Equipment
Novavax, Inc. (Rockville, MD), is developing a novel, recombinant vaccine using cell culture to rapidly produce three proteins specific to an emerging influenza strain that self-assemble into an enveloped, non-infectious particle (virus-like particle or VLP) resembling the influenza virus. The approach provides vaccine within 10 to 12 weeks of identification of the new strain and provides an exact match to the wild-type influenza strain. Yields are significantly higher than egg and mammalian cell culture production. The high yields and use of a nonpathogenic baculovirus allows production in disposable manufacturing equipment. The use of disposables radically lowers facility costs, making the solution affordable to many governments. These advantages are explained below.
Figure 1. The insect-cell based vaccine can be ready in 10–12 weeks, compared to 24 for a traditional method. Part of the time savings is achieved by preparing the reagants for lot-release testing while the vaccine is in production.
The time required to manufacture this insect-cell based vaccine is 10–12 weeks, as shown in Figure 1. This time includes four weeks to make recombinant baculovirus production seed stock from the native influenza virus DNA or from the DNA sequence identified by the relevant health agencies, such as the Centers for Disease Control or the World Health Organization. These seed stocks are used to make manufacturing lots starting in week 5. In parallel, recombinant hemagglutinin (HA), neuraminidase (NA), and matrix (M1) protein are made for the generation of reagents needed for lot-release testing. During weeks 8 to 10, vaccine lots, which have been in production since week 5, are formulated, filled, and packaged for distribution, with release expected in weeks 10 to 12. This is approximately the same time that the first pandemic wave of disease will peak, so having vaccine available this quickly offers the potential to halt the pandemic in its tracks. Traditional manufacturing processes, in contrast, require preparation of a nonpathogenic virus (because an avian virus would kill the fertile egg used in production), and then production of materials used to make reagents. Only when these reagents are available can vaccine be released. The traditional process in this case takes at least 20 to 24 weeks, which means that vaccine is not available until the second wave of pandemic disease, after much of the damage has been done.
Figure 2. Relative yield from traditional vaccine production compared to baculovirus production of a virus-like particle (VLP) based vaccine. Because the VLP vaccine is effective at a much lower dose, the effective yield of the baculovirus production system is 42 times higher. The insect-cell production system also has a very high productivity compared to traditional approaches (Figure 2). Yields in the production of HA are 7–10 times higher (in grams of protein per volume of production lot) than with traditional methods. These high yields make it possible to use small disposable reactors (1,000–2,000 L) instead of 20,000-L reactors needed for mammalian cell culture production. The system developed for making Phase 1 and Phase 2 clinical lots uses 200-L Wave reactors (GE Healthcare, Uppsala, Sweden) for the production of VLPs, followed by a series of purification steps that are also executed in disposable equipment. The current high yields are expected to increase as high-performance disposable stirred reactors (Xcellerex Inc., Waltham, MA) are used to scale up the process to 1,000 L for commercial production. Higher gas transfer rates are expected to support higher insect cell culture densities, thus providing higher volumetric productivity. Further, clinical testing to date has shown that much smaller doses of the VLP vaccine are needed to match the effectiveness of licensed pandemic vaccines (without the use of adjuvants). This means that the yield advantage is further magnified to >40-fold higher productivity in terms of doses of vaccine per liter of cell culture.
Lowering Manufacturing Costs
Novavax contracted Jacobs Engineering (Conshohocken, PA) to provide a conceptual design and cost estimate of a facility for making influenza vaccine using the VLP manufacturing technology in disposables. The plant, which would be capable of producing 75 million doses per season, would be one-third the size of a facility of similar capacity designed for vaccine production in eggs or mammalian cell culture (assuming the same dose).
The cost of the new facility is estimated at $40 million, one-twelfth the cost of the mammalian cell culture facility at 50 million doses per season. The savings result in part from the higher yield, but mainly from the use of disposable manufacturing systems. Instead of large, fixed stainless-steel equipment, connected by a maze of piping and process controls, with automated cleaning and sterilization systems, the disposable approach uses free-standing skids with removable liners, flexible tubing, and disposable filters and chromatography columns. The result is the avoidance of the ever increasing cost of stainless steel, as well as the need for the clean-in-place and sterilize-in-place equipment, parts washers, and clean steam generators required for traditional processes. Further, other facility systems, like contaminated waste collection and kill systems and water-for-injection (WFI) systems are small, because all product contact parts arrive presterilized and are discarded after one use without cleaning. (In a traditional manufacturing process using stainless-steel equipment, cleaning processes contribute the vast majority of the volumes of purified water). This disposables-based approach also requires much less labor. An apparent waste issue of the disposable approach is the volume of plastics that are discarded. However, these high-energy plastic side streams can be incinerated with the cogeneration of power to minimize their environmental impact. Scale-Up Speed
The smaller, less-complicated facility also can be built, commissioned, qualified, and validated much more quickly. The sequential validation of multiple water and steam systems is avoided; as well as the cleaning and sterilization validation required to begin process execution. The final Novavax facility will use manufacturing systems identical to those used in the pilot plant, so no scale-up is required, only the confirming validation runs duplicating what has already been intensely validated during the process development. The result is project execution in about two years, compared to four to six years for a traditional facility. The shorter time supports earlier availability of product for a pandemic, as well as faster recovery of the investment permitted by the shorter and less expensive project.
Comparison of Variable and Fixed Costs
Figure 3. Comparison of the relative variable and fixed costs of traditional vaccine production facilities and insect cell culture–based production. From a cost of goods sold (COGS) perspective, the cost of insect-cell based VLP vaccine is equivalent to the egg-based influenza manufacturing process based on current yields (Figure 3). However, the mix of costs is quite different. Although eggs are a relatively expensive raw material, the remaining raw material costs of egg-based flu vaccines are low. By comparison, the disposable equipment in the Novavax process (e.g., reactor bags, chromatography resin/columns) are more costly. The 7-to 10-fold higher yields of the Novavax system make the per-dose costs reasonable, however, and additional yield gains should provide a COGS advantage for insect-cell based production. One key advantage of the disposable approach is the low labor requirements, because equipment is not cleaned and because the early steps of the egg-based system (i.e., the handling of the eggs) is very labor intensive. Thus, these factors cancel each other out , making the overall variable costs of the two approaches very similar (per gram of HA).
On the fixed cost side, however, the disposable approach has a significant advantage. Lower capital costs mean less depreciation as a fixed cost. Likewise, the lower energy consumption of disposables (no cleaning/sterilization, lower water use) also reduces fixed costs in the facility. The more important implication of low fixed costs, however, is that high facility capacities are not needed to reduce the unit cost impact of the fixed costs. That is, you loose the need for economies of scale and hence you can effectively build a smaller plant, suited for the local population, rather than a large plant to cover many regions.
Proof of Concept
To demonstrate this concept, Novavax has built a pilot plant and commercial launch facility in Rockville, MD, with a fully disposable process capability. The facility houses a single 1,000-L Xcellerex Bioreactor for VLP production, supported by two Wave bioreactors and a 200-L Xcellerex bioreactor for seed preparation. At current yields, the existing process equipment can produce up to 30 million doses of H5N1 vaccine in six months (at 15 mcg/dose). We expect yield to increase such that the facility can support up to 80 million doses in six months, once the new bioreactor conditions are optimized. The facility was built for less than $6 million. The facility is a prototype of what we could place "in-border" to support a government's desire to secure its supply of pandemic vaccine. The overall cost for a facility would be higher than the quoted price, as the Rockville facility does not include formulation, filling, packaging, or media and buffer preparation, which will be contracted out. The cost also does not include quality control or quality assurance space. It still represents a good order-of-magnitude savings over what would be possible with traditional flu vaccine manufacturing approaches and provides countries with a proof of concept for the approach. The construction and qualification was completed in 120 days, which shows the time savings of the disposable approach as well. The facility became fully operational at the end of 2008.
Customizing Vaccine Supply by Region In addition to securing pandemic influenza vaccine supply, this technology approach offers other advantages. First, this technology makes it possible to customize vaccine for a given region. Some regions do not get great benefit from the recommended vaccine formulation. When influenza strains emerge in Southeast Asia, they mutate as they migrate across Asia into Europe and North America, then Africa and South America. The strains recommended for Europe and North America have already passed through Southeast Asia and a different vaccine formula would be advantageous in that region.
Further, additional antigens may be warranted in a region, because multiple B strains can circulate and choosing just one for the seasonal formula has the potential to reduce a vaccine's effectiveness if the alternate strain were to become prominent. Therefore, having local capacity gives governments an opportunity to add an additional strain (even a prepandemic avian strain) to the formula to add value to the seasonal vaccination program.
Next, there are sometimes 'late-breaking' strains of influenza that are antigenically variant from the seasonal formula. The speed and yield of the process in insect cells affords the local government the opportunity to make an additional vaccine in a timely manner to address this risk as needed.
A Flexible Facility
Finally, the process that Novavax has developed for influenza vaccine production is also effective at making other VLP vaccines. The company is developing other VLP vaccine candidates in collaboration with the US National Institute of Health (NIH) that use the same process as influenza manufacturing in insect cells. A change of the clone alone is required to make alternate VLPs. As these and other similar vaccines are developed and approved, pandemic facilities can be used to manufacture these products for local markets. This increases facility utilization and provides a "warm base" operation so the facility is always ready to switch to pandemic influenza vaccine manufacturing mode.
Because Novavax is a 100-person vaccine development company, the ability of this company alone to help the world create a better solution to pandemic influenza is limited. In December 2007, Novavax signed a collaboration with GE Healthcare to expand its ability to provide a pandemic solution to governments around the world. GE is a large company with a history of innovation and a track record for delivering large projects, and the company already serves many governments by constructing hospitals and utility plants. GE will provide the facility engineering, project management, and government access to support the Novavax technology application in delivering in-border or regional vaccine manufacturing capabilities to those that have recognized the need to create this valuable resource.
Summary
An influenza pandemic is a recognized global health risk and many solutions are being developed to attempt to address this serious threat. To date, most solutions fall short of providing an effective response to protect the global population. Vaccination is thought to be a preferred solution, although access to a timely and sufficient supply of vaccine against a new emerging pandemic strain is inadequate in every country around the world. Novavax, Inc.., teamed with GE Healthcare, can offer a solution that answers the call for a fast vaccine response to a novel influenza vaccine strain using an affordable technology for many developed and emerging countries. With the help of government and nongovernmental organizations, the technology can also be available to developing countries. This approach is economically rational and its implementation may actually be capable of halting a pandemic in the countries where it is most likely to start, where those populations have no defense today.
James M. Robinson is vice-president of technical and quality operations at Novavax, Inc., Rockville, MD 20850, 240.268.2019
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dothedd
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NOVAVAX
Sept 19, 2013 23:41:45 GMT -5
Post by dothedd on Sept 19, 2013 23:41:45 GMT -5
Contact: Barclay Phillips SVP, Chief Financial Officer and Treasurer Novavax, Inc. 240-268-2000
Novavax to Host an Analyst and Investor Update Call with Webcast
Rockville, MD (September 17, 2013) - Novavax, Inc. (Nasdaq: NVAX), a clinical-stage biopharmaceutical company creating novel recombinant nanoparticle vaccines and vaccine adjuvants, today announced that it will host the Analyst and Investor Update Call with Webcast on Tuesday, September 24, 2013, from 9:00 a.m. - 11:00 a.m. (EDT). Senior management, including Stanley Erck, President and Chief Executive Officer; Gregory Glenn, MD, SVP and Chief Medical Officer; Lou Fries, MD, VP of Clinical & Medical Affairs; and Gale Smith, PhD, VP of Vaccine Development, along with special guest speaker Dr. Pedro A. Piedra, Professor of Molecular Virology and Microbiology at the Baylor College of Medicine, and a key-opinion leader in the field of pediatric infectious diseases and viral respiratory illnesses, will present on the following topics: Corporate Overview Recombinant Nanoparticle Technology: an Engine for Growth The Novavax Influenza Programs The RSV Landscape The Novavax RSV Programs
“Novavax is excited about the opportunity to update the investor community on the development plans for our lead candidates,” said Stan Erck, President and CEO. “This meeting allows us to set the stage for 2014 development and to provide some visibility into 2015.”
The dial-in number for the conference call is 1 (877) 212-6076 (U.S. or Canada) or 1 (707) 287-9331 (international). The webcast can 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 call will be available starting at 1:00 pm on Tuesday, September 24, 2013 until midnight November 5, 2013. To access the replay by telephone, dial 1 (855) 859- 2056 (U.S. or Canada) or 1 (404) 537-3406 (international) and use passcode 65051892. The replay will also be available as a webcast and can be found on the “Investor Info”/ “Events” on the Novavax website.
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dothedd
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NOVAVAX
Sept 20, 2013 14:39:05 GMT -5
Post by dothedd on Sept 20, 2013 14:39:05 GMT -5
INSIDERMONKEY ARTICLE 9 20 13 Novavax, Inc. (NASDAQ:NVAX) At some point early in your life, you probably picked up a case of RSV (respiratory syncytial virus). Most babies do, and then go on to make a full recovery. But for babies who have compromised immune systems, especially those who are born premature, RSV can be lethal. Worldwide, roughly 3 million kids and at-risk elderly people are hospitalized each year, leading to an estimated 66,000 deaths.Doctors will be convening in Portugal next month to discuss the latest approaches to treating RSV (there is currently no vaccine). While several biotech firms are working on the problem, "Novavax leads the field," according to analysts at Lazard. The company is expected to discuss its current clinical trials at the event, which may explain why this stock has already been perking up lately.
The RSV meetings are just a near-term catalyst for this stock. Long term, Novavax is pursuing a vaccine for the herpes virus, bird flu and even the seasonal flu virus. Those potential market opportunities explain why Novavax's market value has already swelled to nearly $500 million. Yet analysts at Lazard see more than 200% upside to their $11 target price. They view the company's drug development and approval as a "when" and not "if" situation. Management will be holding a detailed discussion of the drug pipeline next week, making this a good time to brush up on this under-the-radar biotech investment opportunity.
Novavax to Host an Analyst and Investor Update Call with Webcast Rockville, MD (September 17, 2013) - Novavax, Inc. (Nasdaq: NVAX), a clinical-stage biopharmaceutical company creating novel recombinant nanoparticle vaccines and vaccine adjuvants, today announced that it will host the Analyst and Investor Update Call with Webcast on Tuesday, September 24, 2013, from 9:00 a.m. - 11:00 a.m. (EDT). Senior management, including Stanley Erck, President and Chief Executive Officer; Gregory Glenn, MD, SVP and Chief Medical Officer; Lou Fries, MD, VP of Clinical & Medical Affairs; and Gale Smith, PhD, VP of Vaccine Development, along with special guest speaker Dr. Pedro A. Piedra, Professor of Molecular Virology and Microbiology at the Baylor College of Medicine, and a key-opinion leader in the field of pediatric infectious diseases and viral respiratory illnesses, will present on the following topics: Corporate Overview Recombinant Nanoparticle Technology: an Engine for Growth The Novavax Influenza Programs The RSV Landscape The Novavax RSV Programs
“Novavax is excited about the opportunity to update the investor community on the development plans for our lead candidates,” said Stan Erck, President and CEO. “This meeting allows us to set the stage for 2014 development and to provide some visibility into 2015.”
The dial-in number for the conference call is 1 (877) 212-6076 (U.S. or Canada) or 1 (707) 287-9331 (international). The webcast can 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 call will be available starting at 1:00 pm on Tuesday, September 24, 2013 until midnight November 5, 2013. To access the replay by telephone, dial 1 (855) 859- 2056 (U.S. or Canada) or 1 (404) 537-3406 (international) and use passcode 65051892. The replay will also be available as a webcast and can be found on the “Investor Info”/ “Events” on the Novavax website. Read more at www.insidermonkey.com/blog/three-stocks-under-5-with-triple-digit-upside-250424/#suCS8svBhqgcxg5l.99
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dothedd
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NOVAVAX
Sept 25, 2013 20:04:48 GMT -5
Post by dothedd on Sept 25, 2013 20:04:48 GMT -5
SEEKING ALPHA ARTICLE
Novavax: A Vaccine Company On The Rise
Sep 25 2013, 14:31
Disclosure: I am long NVAX. I wrote this article myself, and it expresses my own opinions. I am not receiving compensation for it (other than from Seeking Alpha). I have no business relationship with any company whose stock is mentioned in this article. (More...)
Company overview and opportunity
Novavax, Inc. (NVAX) is a clinical-stage biopharmaceutical company that uses recombinant nanoparticle technology to develop vaccines for a wide variety of infectious diseases. The company presently has six vaccine candidates undergoing clinical trials, with a seventh (rabies) being readied for a Phase-1 study later this year. Of the six vaccine candidates in active clinical trials, the most advanced are the Respiratory Syncytial Virus (RSV) and Seasonal Quadrivalent Influenza vaccines, both of which are in advanced Phase 2 trials. Getting down to brass tacks, the RSV vaccine is believed by analysts to be the most important short-term value driver for the company, with Lazard Capital recently placing an eye-popping $11 target on shares of NVAX based on this candidate alone.
To provide some context, RSV is a common virus that infects the lungs and breathing passages. Although healthy adults generally recover within a week's time, the infection can be deadly in infants and elderly patients with compromised immune systems. An effective prophylactic medication (Palivizumab) is presently available for preterm babies born prior to 35 weeks, but there isn't an FDA approved vaccine for any other demographic. Because of the global nature of RSV and the enormity of this unmet medical need, an effective vaccine that treats a wide variety of potential patients could be valued well into the billions.
Analysts are optimistic about Novavax's RSV vaccine candidate for two reasons. Firstly, the potential market for a successful RSV vaccine is easily worth 3-4X times Novavax's current market cap of $490M. Secondly, Novavax has repeatedly announced top-line results from its host of Phase 2 clinical trials aimed at creating a broad-based RSV vaccine.
Fundamental and Technical Perspective
As of June 30th, 2013, the company had $40.6 M in cash and cash equivalents, $30M of which was raised through the sale of common stock between 2011-2013. Yesterday, the company announced that it had raised an additional $82.6 M via a public offering (net proceeds) of > 27 M shares at $3.14, giving the company approximately $120 M in cash and cash equivalents. Because of increased expenses related to the company's advancing clinical trials, Novavax's cash burn rate has increased to approximately $3M a month this year, up $1.4 M compared to the same period in 2012.
Revenue generated from the BARDA contract and the PATH clinical development program came in at $7.4M for the first six months of 2013, which is a 37% decrease in revenue from these agreements year-over-year. To provide some context, the HHS BARDA contract was awarded in 2011 for the development of Novavax's seasonal and pandemic (H5N1) influenza vaccines. At the company's recent investor and analyst update, Novavax announced that the company will move forward with the clinical programs funded through BARDA, which is a major achievement both financially and scientifically for Novavax. Specifically, the continuation of this agreement will provide much needed revenue, and it signals that the company is steadily progressing towards a pivotal Phase III study for its nanoparticle vaccine platform. Overall, the company is now on financially stable footing and should have no reason to raise additional capital through dilutive measures within the next three years.
Shares of NVAX are now up approximately 70% year to date, despite more than 10% of the float still being short. The Relative Strength Index (RSI) stands at 56 at the time of writing this article, suggesting the shares are neither overbought nor oversold. Even so, NVAX is trading 13% higher than its 50 day SMA, and almost 42% higher than its 200 day SMA. From a purely technical perspective, NVAX would appear to be ready for a consolidation phase to form a new base near all-time highs for the stock. As such, I believe now is a good time to begin building a long term position in NVAX.
Conclusions
Companies developing the next generation of vaccines, like Inovio Pharmaceuticals (INO) and Novavax, have unquestionably caught the eye of investors in recent years. While these cutting-edge vaccine makers are certainly not the first companies to try to tackle global pandemics with novel technological approaches, they may be among the first in actually succeeding. Simply put, the technology behind non-protein based vaccines appears to have finally caught up with the hype of the past decade, evinced by the plethora of top-line results emanating from synthetic vaccine makers of late. Within this exciting subsector, I believe Novavax is an intriguing speculative play that could easily double in PPS over the next few months if the company continues to report positive clinical data. Backing this claim, the company currently has enough cash where dilution shouldn't be a major risk factor in the short-term, insiders have bought over 300k shares on the open market in the past 12 months, and the company's market cap is markedly lower than what a successful RSV vaccine would be worth (i.e., billions). In sum, Novavax looks to be a rising star in this up and coming sector, and offers investors an excellent risk-to-reward ratio going forward.
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dothedd
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Post by dothedd on Sept 25, 2013 20:30:56 GMT -5
SEEKING ALPHA ARTICLE
Novavax: Why Investors Are Excited Now
Sep 25 2013, 12:22
Disclosure: I have no positions in any stocks mentioned, and no plans to initiate any positions within the next 72 hours. I wrote this article myself, and it expresses my own opinions. I am not receiving compensation for it (other than from Seeking Alpha). I have no business relationship with any company whose stock is mentioned in this article. Novavax, Inc. (NVAX) describes itself as a clinical-stage biopharmaceutical company creating novel vaccines and vaccine adjuvants to address a broad range of infectious diseases worldwide. Using innovative proprietary recombinant protein nanoparticle vaccine technology, the company produces vaccine candidates to efficiently and effectively respond to both known and newly emergent diseases.
On Tuesday September 24, Novavax released a lot of information that has investors excited. Novavax has been working to bring its manufacturing platform and production process out of the Phase I and II stage into a process that it considers locked and suitable for Phase III and commercialization. My attempt with this article is to highlight for investors the important data points.
1. Game on
Novavax announced today it is preparing for the next round of clinical studies with the U.S. Department of Health and Human Services, Biomedical Advanced Research and Development Authority (BARDA), for its quadrivalent seasonal influenza vaccine and its pandemic influenza vaccine. This is an important step toward ultimate commercialization and shareholder value.
2. Well financed
Novavax also announced a public offering of $82.6 million in equity priced at $3.14 per share, near its 52-week high of $3.50 per share. It's always a good sign that large investors are willing to pony up so much money despite a stock trading near its high. The PR was vague on details as to the extent this funding will secure Novavax, but the CEO spilled the beans during the Q&A session of the presentation that followed:
We're looking to fund the program in ways that we have our flu program to the extent that we can with non-diluted financing, but it also requires investor participation. This money that we raised is designed to take us into 2016, which will get us a long way on all 3 different programs, and then, we'll see where we go from there.
Looks like investors don't have to worry about any more dilution or capital concerns or anything else financial for quite a while.
3. Possible stockpile purchase coming for Novavax H7N9 vaccine
Novavax's CEO deep in the Q&A session gave a cautionary yet eye-opening response to an analyst question:
It's somewhat difficult to predict the actions of the U.S. government or other governments. But if history prevails, BARDA and the U.S. government have, in the past, stockpiled hundreds of millions of dollars of H5N1 vaccine. They have purchased, as I think Gale pointed out, over $1 billion worth of H1N1 - Lou pointed out the H1N1, and I think that the government does stockpile. Having said that, there is not a stockpile plan in action like this minute for H7N9, but I would be surprised if there weren't at some point.
Over $1 billion in possible orders for just one vaccine for a company excited to have $80 million in financing would likely have investors causing a stampede to get into the stock. As the CEO pointed out there's no such order yet, but he would be surprised if one doesn't come.
Most of the presentation was filled with complex details about the science behind what Novavax is doing. I won't try to bore you with the details. It's the results that are exciting for the investment thesis. Financially, Novavax is very sound with plenty of cash in the bank, its programs moving forward, and it's sitting on a wild card of a possible government order to stockpile one of its vaccines. Investors can now sit back and watch the events and developments unfold, be they positive or negative, attempt to study the science and get an edge if they wish and not have to worry about the funding angle of Novavax. Often funding is a worry that eats up most of the time, research and concern of investors in development-stage biotechs. Novavax investors: worry no more.
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dothedd
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Post by dothedd on Oct 8, 2013 9:06:45 GMT -5
Novavax Completes $100 Million Public Offering of Common Stock Rockville, MD (September 27, 2013)—Novavax, Inc. (Nasdaq: NVAX) today announced the closing of its previously announced underwritten public offering of 31,846,950 shares of its common stock, including 4,153,950 shares of common stock that were issued upon the exercise in full of the over-allotment option granted to the underwriters. The shares were sold at the public offering price of $3.14 per share, resulting in total gross proceeds of $100 million dollars. Novavax will receive net proceeds, after deducting underwriting discounts and commissions and offering expenses, of approximately $94.6 million from the offering. Lazard Capital Markets LLC acted as the sole book-running manager for the offering, with Piper Jaffray & Co. and Wedbush PacGrow Life Sciences acting as co-lead managers and Burrill Securities LLC acting as co-manager. The shares described above were issued pursuant to a final prospectus supplement and accompanying prospectus. The company filed the final prospectus supplement relating to the offering with the Securities and Exchange Commission (“SEC”) on September 24, 2013, which is available along with the accompanying prospectus filed with the SEC in connection with the company’s shelf registration statement on Form S-3, previously declared effective by the SEC, on the SEC’s website at www.sec.gov. Copies of the final prospectus supplement and the accompanying prospectus may be obtained by sending a request to: Lazard Capital Markets LLC, 30 Rockefeller Plaza, 60th Floor, New York, NY 10020, or via telephone at 800-542- 0970. This press release does not and shall not constitute an offer to sell or the solicitation of an offer to buy, nor will there be any sale of these securities in any state or jurisdiction in which such offer, solicitation or sale would be unlawful prior to registration or qualification under the securities laws of any such state or jurisdiction. About Novavax Novavax, Inc. (Nasdaq: NVAX) is a clinical-stage biopharmaceutical company creating vaccines and vaccine adjuvants to address a broad range of infectious diseases worldwide. Using innovative proprietary recombinant protein nanoparticle technology, the company produces vaccine candidates to efficiently and effectively respond to both known and newly emergent diseases.
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dothedd
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Post by dothedd on Oct 8, 2013 9:08:12 GMT -5
Contact: Barclay A. Phillips SVP, Chief Financial Officer and Treasurer Novavax, Inc. 240-268-2000 Novavax Initiates Dose-Confirmatory Phase 2 Clinical Trial of its RSV Vaccine Candidate Rockville, MD (October 7, 2013)–/GlobeNewswire/-Novavax, Inc. (Nasdaq: NVAX) today announced that enrollment has begun in a Phase 2 dose-confirmatory clinical trial of its respiratory syncytial virus (RSV) vaccine candidate in women of childbearing age. This randomized, blinded, placebo-controlled Phase 2 study will evaluate the immunogenicity and safety of multiple formulations of Novavax’ RSV-F protein nanoparticle vaccine candidate with aluminum phosphate as an adjuvant. The study is scheduled to enroll 720 women of childbearing age who will receive either one or two intramuscular injections at each dose level of vaccine or placebo at days 0 and 28. Immunogenicity and safety will be evaluated over three month and six month periods, respectively. “This trial represents important progress for our RSV vaccine, which is being developed to protect young infants through maternal immunization,” said Gregory Glenn M.D., Senior Vice President and Chief Medical Officer of Novavax. “This study will help define the dose and dose regimen and expand the safety database for our maternal immunization strategy. These are all essential steps in the advancement of this important vaccine towards licensure.” About RSV RSV is a respiratory pathogen that afflicts all humans regardless of age. In healthy adults, RSV infections are generally mild to moderate in severity, but may be more severe in infants and young children as well as the elderly and adults with underlying chronic cardiac or pulmonary disease. Globally, RSV is a common cause of childhood respiratory infection, with a disease burden of 64 million cases and approximately 160,000 deaths annually. Severe RSV disease results in 3.4 million hospital admissions per year globally and disproportionately affects infants below six months of age. It is estimated that between 11,000 to 17,000 elderly and high risk adults die of RSV infection annually in the U.S., with up to 180,000 hospitalizations for serious respiratory symptoms. Currently, there is no approved RSV prophylactic vaccine available for either of these populations. About Novavax Novavax, Inc. (Nasdaq: NVAX) is a clinical-stage biopharmaceutical company creating novel vaccines and vaccine adjuvants to address a broad range of infectious diseases worldwide. Using innovative proprietary recombinant protein nanoparticle vaccine technology, the company produces vaccine candidates to efficiently and effectively respond to both known and newly emergent diseases. Additional information about Novavax is available on the company’s website, novavax.com
CONTACT: Barclay A. Phillips Senior Vice President, Chief Financial Officer Novavax, Inc. 240-268-2000
David Schull or Andrea Flynn, Ph.D. Russo Partners, LLC 212-845-4271 David.schull@russopartnersllc.com Andrea.flynn@russopartnersllc.com
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dothedd
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NOVAVAX
Oct 8, 2013 15:39:04 GMT -5
Post by dothedd on Oct 8, 2013 15:39:04 GMT -5
Upcoming Events
RSV Vaccines for the World Porto, Portugal, Tiara Park Atlantico Hotel October 14-16, 2013 Presenters: Gregory Glenn, Louis Fries and Gale Smith
ISBioTech 1st Fall Meeting Rosslyn, Virginia October 14-16, 2013 Presenter: Timothy Hahn
Influenza & Coronavirus Pandemic Preparedness Asia 2013 Singapore, Traders Hotel October 23-24, 2013 Presenter: Gregory Glenn
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dothedd
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NOVAVAX
Nov 7, 2013 16:41:54 GMT -5
Post by dothedd on Nov 7, 2013 16:41:54 GMT -5
Novavax Third Quarter 2013 Financial Results Rockville, Maryland November 7, 2013, 4:30 p.m. ET. Dial-in: 1-877- 212-6076 (domestic) or 1-707-287-9331 (international) Conference ID: 93831495 Webcast: click here: www.novavax.com/go.cfm?do=Page.View&pid=36
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dothedd
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NOVAVAX
Nov 13, 2013 18:43:02 GMT -5
Post by dothedd on Nov 13, 2013 18:43:02 GMT -5
New England Journal of Medicine Publishes Positive Data From Clinical Trial of Novavax' Vaccine Against H7N9 Avian Flu 1 hours 29 minutes ago - DJNF
New England Journal of Medicine Publishes Positive Data From Clinical Trial of Novavax' Vaccine Against H7N9 Avian Flu -- Data are industry's first from clinical trial of vaccine against A(H7N9) strain of influenza
-- 81% of 5ug adjuvanted vaccine recipients had protective HAI levels
-- 97% of 5ug adjuvanted vaccine recipients had anti-neuraminidase antibody responses
-- Protective levels achieved from vaccinations within 116 days of the announced outbreak of novel lethal H7N9 virus
-- Dose-sparing formulation shows significant potential utility in the event of a pandemic
-- Vaccine safety consistent with previously tested adjuvanted pandemic vaccines
ROCKVILLE, Md., Nov. 13, 2013 (GLOBE NEWSWIRE) -- Novavax, Inc. (Nasdaq:NVAX) today announced that positive clinical data for the company's virus-like particle (VLP) vaccine candidate against A(H7N9) influenza were published online in the Correspondence section of The New England Journal of Medicine. The correspondence can be found at www.nejm.org/doi/full/10.1056/NEJMc1313186 and will appear in the December 26, 2013 print edition.
The study, conducted in 284 adult male and female subjects, examined the safety and immunogenicity of two administrations of Novavax' A(H7N9) VLP vaccine candidate on day 0 and day 21. Subjects were administered either placebo, 15 or 45 ug of vaccine alone, or 5 or 15ug of vaccine with either 30 or 60 ISCO(R) units of the saponin-based ISCOMATRIX(R) adjuvant, developed by CSL Limited in Australia. Serology was assessed at Days 0, 21 and 35 post-first immunization.
The Novavax A(H7N9) VLP vaccine candidate was generally well tolerated, and the safety was in line with the company's previous findings with its influenza VLP antigens using ISCOMATRIX(R) adjuvant. Overall, as with other adjuvanted influenza vaccines, there was an increase in transient local and systemic reactions in the adjuvanted in contrast to the non-adjuvanted formulations, but there were no treatment-related SAEs in the active groups. The A(H7N9) VLP vaccine candidate induced hemagglutination-inhibition (HAI) antibody titers of >=1:40 (seroprotection) and a four-fold HAI antibody rise (serconversion) against H7N9 in 81% of subjects at the 5mg dose of A(H7N9) antigen with 60 ISCO(R) units of adjuvant, and 73% of subjects receiving 5mg dose of A(H7N9) antigen with either adjuvant dose level. The vaccine also elicited anti-neuraminidase (NA) antibodies against N9 in 92 to 97% of subjects receiving 5mg with either adjuvant dose level.
The A(H7N9) influenza strain has emerged recently as a potential pandemic concern. Less than ten (10) days after the Chinese Health authorities announced an outbreak of this novel avian influenza in humans (137 total confirmed cases, including 45 deaths, to date), Novavax obtained the genetic sequence of the strain and commenced production of a recombinant vaccine. Clinical trial material was manufactured and released in late June 2013 with the first doses injected in humans in early July 2013. Less than four months after the novel A(H7N9) virus had been identified and sequenced, Novavax' H7N9 VLP vaccine, with the higher-dose of ISCOMATRIX(R) adjuvant, has achieved immune responses likely to be protective in 81% of recipient subjects with as little as 5ug of antigen.
"The production and testing of a vaccine for a novel, lethal influenza virus in such a short time period validates the agility of Novavax' technology in addressing pandemic threats," said Dr. Lou Fries, the company's Vice President of Clinical and Medical Affairs. "The performance of our vaccine candidate is particularly important in light of the speed with which pandemic outbreaks can unfold. Often, an initial outbreak of a novel influenza virus is followed by a more severe and widespread outbreak at the onset of the next fall and winter respiratory virus season, as seen in 2009 with H1N1. Unfortunately, vaccine makers in 2009 were unable to produce vaccine in advance of the second wave and there was little impact of vaccine upon H1N1 disease in the first year. Past H7-based vaccine candidates have been poorly immunogenic and thus could not be advanced as viable vaccine candidates. This risk appears to have been overcome by our H7N9 adjuvanted VLP vaccine."
Stanley C. Erck, President and Chief Executive Officer of Novavax, added, "As evidenced by our correspondence in The New England Journal of Medicine, this is a critical accomplishment for pandemic preparedness. Building on the positive clinical results with our H5N1 VLP vaccine candidate from last October, these recently gathered data from our A(H7N9) influenza vaccine give further confirmation that the Novavax vaccine platform deserves to play a key role in addressing evolving pandemic threats. We have used recombinant VLP technology to demonstrate that timely responses are possible, and we are proud to be the first company to produce a viable H7N9 vaccine. Furthermore, we are pleased that HHS-BARDA has recognized this achievement and asked us to focus our pandemic vaccine development under our HHS-BARDA contract on our H7N9 vaccine candidate."
About H7N9 Avian Flu
Following recognition of the first human infections with avian-origin influenza A(H7N9) and their attendant severity in March 2013, public health officials from around the world called for immediate and preemptive development of surveillance, diagnostic and clinical intervention tools in the event that the A(H7N9) virus becomes transmissible among humans. According to Keiji Fukuda of the WHO, there is high concern over potential for A(H7N9) to gain sustainable person-to-person transmissibility. He noted that over a two-month period in China, as many H7N9 cases occurred as caused by H5N1 cases over 10 years. Additionally, molecular genetic changes occurred, suggesting adaptation of the virus to humans. After a quiescent period during the summer months, four new cases of human A(H7N9) disease have been reported since October 7, prompting concerns and expectations over the virus reemerging in human populations in the coming winter season.
About Novavax
Novavax, Inc. (Nasdaq:NVAX) is a clinical-stage biopharmaceutical company creating novel vaccines and vaccine adjuvants to address a broad range of infectious diseases worldwide. Using innovative proprietary recombinant protein nanoparticle vaccine technology, the company produces vaccine candidates to efficiently and effectively respond to both known and newly emergent diseases. Novavax is involved in several international partnerships, including collaborations with Cadila Pharmaceuticals of India, LG Life Sciences of Korea, PATH and recently acquired Isconova AB, a leading vaccine adjuvant company located in Sweden. Together, Novavax' network supports its global commercialization strategy to create real and lasting change in the biopharmaceutical and vaccinology fields. Additional information about Novavax is available on the company's website, novavax.com.
About ISCOMATRIX(R) adjuvant ISCOMATRIX(R) adjuvant is made from saponin, cholesterol and phospholipid which, under defined conditions, form cage-like structures typically 40-50nm in diameter. The optimized ISCOMATRIX(R) adjuvant is well defined, has minimal impurities and does not use any materials of animal origin. Additionally, improvements have been made to the manufacturing processes to ensure it can be reproduced on a large scale. ISCOMATRIX(R) adjuvant is currently manufactured at commercial scale at CSL's facility in Kankakee, Illinois.
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, 2012,and Form 10-Q for the period ended June 30, 2013, both 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.
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Post by Deleted on Nov 13, 2013 21:07:18 GMT -5
New England Journal of Medicine Publishes Positive Data From Clinical Trial of Novavax' Vaccine Against H7N9 Avian Flu Such good news!!! Thanks for posting it.
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dothedd
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NOVAVAX
Nov 13, 2013 22:08:24 GMT -5
Post by dothedd on Nov 13, 2013 22:08:24 GMT -5
YOUR WELCOME LW .... YOU WERE MISSING FROM THE BOARD AND YOU HAVE BEEN MISSED! HAPPY TO SEE YOU HAVE RETURNED.
GO NOVAVAX:
2013 PRESS RELEASES New England Journal of Medicine Publishes Positive Data From Clinical Trial of Novavax’ Vaccine Against H7N9 Avian Flu 11/13/13 Novavax Reports Third-Quarter 2013 Financial Results 11/07/13 Novavax to Report Third Quarter 2013 Financial Results on November 7, 2013 10/30/13 Novavax Initiates Dose-Confirmatory Phase 2 Clinical Trial of its RSV Vaccine Candidate 10/07/13 Novavax Offering Closing Press Release 09/27/13 Novavax to Initiate Seasonal and Pandemic Influenza Trials in Collaboration with BARDA 09/24/13 Novavax Prices Public Offering of Common Stock 09/24/13 Novavax to Host an Analyst and Investor Update Call with Webcast 09/17/13 Novavax Highlights Positive Results from Partner’s Clinical Trial of Vaccine using Matrix-M™ 09/13/13 ICAAC Presentations Highlight Potential Protective Effects of Novavax’ RSV Vaccine Candidate 09/11/13 Novavax to Present at the 2013 Stifel Nicolaus Healthcare Conference 09/05/13 Novavax to Present RSV Vaccine Clinical and Preclinical Results at ICAAC 09/03/13 Novavax Acquires Isconova; Extended Public Tender Offer Period Closed 08/22/13 Novavax Förvärvar Isconova; Förlängda Acceptperioden I Erbjudandet Stängd 08/22/13 Novavax Reports Second-Quarter 2013 Financial Results 08/08/13 NOVAVAX to Present at the 2013 Wedbush Life Sciences Conference 08/06/13 Novavax to Report Second Quarter 2013 Financial Results on August 8, 2013 08/01/13 NOVAVAX FÖRVÄRVAR ISCONOVA; FÖRLÄNGER ACCEPTPERIODEN I ERBJUDANDET FÖR KVARVARANDE AKTIEÄGARE I ISCONOVA 07/31/13 NOVAVAX ACQUIRES ISCONOVA; EXTENDS PUBLIC TENDER OFFER PERIOD FOR REMAINING ISCONOVA SHAREHOLDERS 07/31/13 Novavax Publishes Positive Preclinical Efficacy Data Against Influenza A(H7N9) 07/30/13 Novavax Initiates First Phase 1 Clinical Trial of its A(H7N9) Influenza Vaccine Candidate 07/08/13 Novavax Announces Positive Top-Line Results from Phase 1 Clinical Trial of RSV Vaccine Candidate in Elderly 07/02/13 Novavax Appoints Barclay “Buck” Phillips as Senior Vice President and Chief Financial Officer 06/24/13 Novavax Produces MERS-CoV Vaccine Candidate 06/06/13 Novavax Announces Public Offer for all Outstanding Shares of Isconova 06/04/13 NOVAVAX AND ISCONOVA TO COMBINE; NOVAVAX LAUNCHES RECOMMENDED PUBLIC OFFER TO ACQUIRE ISCONOVA 06/04/13 NOVAVAX OCH ISCONOVA GÅR SAMMAN; NOVAVAX OFFENTLIGGÖR REKOMMENDERAT OFFENTLIGT UPPKÖPSERBJUDANDE TILL AKTIEÄGARNA I ISCONOVA 06/04/13 Novavax H7N9 VLP Influenza Vaccine Enters Animal Testing 05/10/13 Novavax Reports First-Quarter 2013 Financial Results 05/07/13 Novavax to Report First-Quarter 2013 Financial Results on May 7, 2013 04/26/13 Novavax to Present at 12th Annual Needham Healthcare Conference 04/25/13 Novavax to Review Recent Findings from Vaccine Programs at World Vaccine Congress and Expo in Washington, DC 04/15/13 Novavax Appoints Amy B. Fix Vice President of Regulatory Affairs 04/10/13 Novavax Reports Positive Top-Line Results From Phase II Clinical Trial of RSV Vaccine Candidate in Women of Childbearing Age 04/02/13 Novavax Reports Progress on RSV Vaccine at the XV International Symposium on Respiratory Viral Infections 03/18/13 Novavax to Present at the 25th Annual ROTH Conference 03/13/13 Novavax, CPLB and ICGEB Collaboration Honored for Malaria Vaccine Progress at Vaccine World Summit India 2013 03/08/13 Novavax Reports Fourth Quarter and Year-End 2012 Financial Results 03/01/13 Novavax to Report 2012 Fourth-Quarter and Year-End Financial Results on March 1, 2013 02/22/13 NOVAVAX to Present at the 15th Annual Bio CEO & Investor Conference 02/07/13 BARDA Continues Novavax’ Influenza Vaccine Programs Following In-Process Review 01/24/13
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dothedd
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NOVAVAX
Nov 13, 2013 22:34:39 GMT -5
Post by dothedd on Nov 13, 2013 22:34:39 GMT -5
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Post by Deleted on Nov 13, 2013 23:36:27 GMT -5
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dothedd
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NOVAVAX
Nov 15, 2013 18:05:24 GMT -5
Post by dothedd on Nov 15, 2013 18:05:24 GMT -5
THAT'S COOL ....
I need to figure out how to do that!
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dothedd
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NOVAVAX
Nov 26, 2013 18:13:10 GMT -5
Post by dothedd on Nov 26, 2013 18:13:10 GMT -5
Tue, Nov 26, 2013, 6:10pm EST - US Markets are closed Novavax to Present at the 25th Annual Piper Jaffray Healthcare Conference
ROCKVILLE, Md., Nov. 26, 2013 (GLOBE NEWSWIRE) -- Novavax, Inc. (NVAX) a clinical-stage vaccine company, announced today that Stanley C. Erck, President and Chief Executive Officer, will present at the 25th Annual Piper Jaffray Healthcare Conference on December 3, 2013 at 1:30pm ET in New York City at the New York Palace Hotel.
A live webcast link for the presentation can be accessed via the company website at www.novavax.com under Investor Info/Events.
About Novavax
Novavax, Inc. (NVAX) is a clinical-stage biopharmaceutical company creating novel vaccines and vaccine adjuvants to address a broad range of infectious diseases worldwide. Using innovative proprietary recombinant protein nanoparticle vaccine technology, the company produces vaccine candidates to efficiently and effectively respond to both known and newly emergent diseases. Novavax is involved in several international partnerships, including collaborations with Cadila Pharmaceuticals of India, LG Life Sciences of Korea, PATH and recently acquired Isconova AB, a leading vaccine adjuvant company located in Sweden. Together, Novavax' network supports its global commercialization strategy to create real and lasting change in the biopharmaceutical and vaccinology fields. Additional information about Novavax is available on the company's website, novavax.com.
Contact: Barclay Phillips SVP, Chief Financial Officer and Treasurer Novavax, Inc. 240-268-2000
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dothedd
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Post by dothedd on Dec 3, 2013 20:15:44 GMT -5
ANYONE WANT TO SPECULATE WHAT IS GOING ON WITH NOVAVAX! : - )
The NASDAQ Last Sale Intraday Trade History Report shows real-time time and sales data for all of your favorite U.S. stocks (listed on NASDAQ, NYSE, and AMEX)Read more: www.nasdaq.com/symbol/nvax/time-sales#ixzz2mSnT5auP Novavax, Inc. NLS Time (ET) NLS Price NLS Share Volume
16:00:04 $ 3.98 5,449,690 16:00:02 $ 3.98 900,000 16:00:02 $ 3.98 1,500 16:00:02 $ 3.98 900,000 16:00:02 $ 3.98 900,000 16:00:02 $ 3.98 900,000 16:00:02 $ 3.98 900,000 16:00:02 $ 3.98 20 16:00:02 $ 3.98 310 16:00:02 $ 3.98 236 16:00:02 $ 3.98 8,262 16:00:02 $ 3.98 5,200 16:00:02 $ 3.98 5,253 16:00:02 $ 3.98 577 16:00:02 $ 3.98 861,170 16:00:02 $ 3.98 577 16:00:02 $ 3.98 34,004 16:00:02 $ 3.98 23,949 16:00:02 $ 3.98 25 16:00:02 $ 3.98 1,550 16:00:02 $ 3.98 1,000 16:00:02 $ 3.98 6,057 15:59:59 $ 3.97 300 15:59:59 $ 3.97 2,900 15:59:59 $ 3.97 200 15:59:59 $ 3.97 3,200 15:59:59 $ 3.97 5,535 15:59:59 $ 3.97 2,765 15:59:59 $ 3.97 500 15:59:59 $ 3.97 273 15:59:59 $ 3.98 12,000 15:59:59 $ 3.98 417 15:59:59 $ 3.98 3,182 15:59:59 $ 3.98 100 15:59:59 $ 3.98 1,218 15:59:59 $ 3.98 4,500 15:59:58 $ 3.98 157 15:59:58 $ 3.98 4,112 15:59:57 $ 3.98 200 15:59:57 $ 3.985 100 15:59:57 $ 3.98 100 15:59:57 $ 3.985 100 15:59:57 $ 3.985 100 15:59:56 $ 3.98 995 15:59:56 $ 3.98 1,949 15:59:56 $ 3.98 700 15:59:55 $ 3.98 100 15:59:55 $ 3.98 100 15:59:55 $ 3.98 100 15:59:55 $ 3.98 200
NLS Time (ET) NLS Price NLS Share Volume 15:59:55 $ 3.98 260 15:59:55 $ 3.98 1,040 15:59:55 $ 3.98 185 15:59:55 $ 3.98 595 15:59:55 $ 3.98 4,744 15:59:55 $ 3.98 1,095 15:59:55 $ 3.98 200 15:59:55 $ 3.98 520 15:59:55 $ 3.98 2,000 15:59:55 $ 3.98 170 15:59:55 $ 3.98 1,179 15:59:54 $ 3.985 100 15:59:54 $ 3.985 100 15:59:54 $ 3.985 100 15:59:54 $ 3.985 100 15:59:54 $ 3.985 100 15:59:54 $ 3.98 1,300 15:59:54 $ 3.98 100 15:59:54 $ 3.98 100 15:59:53 $ 3.98 100 15:59:53 $ 3.98 100 15:59:53 $ 3.99 1,300 15:59:53 $ 3.98 300 15:59:53 $ 3.98 100 15:59:52 $ 3.99 100 15:59:52 $ 3.98 200 15:59:52 $ 3.99 100 15:59:52 $ 3.99 100 15:59:52 $ 3.99 100 15:59:52 $ 3.99 100 15:59:52 $ 3.99 100 15:59:51 $ 3.985 100 15:59:51 $ 3.99 100 15:59:51 $ 3.985 100 15:59:51 $ 3.99 900 15:59:51 $ 3.985 100 15:59:50 $ 3.98 593 15:59:50 $ 3.98 107 15:59:49 $ 3.98 200 15:59:49 $ 3.99 100 15:59:49 $ 3.99 100 15:59:49 $ 3.99 100 15:59:49 $ 3.99 1,143 15:59:49 $ 3.99 1,357 15:59:47 $ 3.99 1,600 15:59:47 $ 3.985 100 15:59:47 $ 3.98 307 15:59:47 $ 3.98 2,660 15:59:46 $ 3.985 100 15:59:46 $ 3.98 2,000
Read more: www.nasdaq.com/symbol/nvax/time-sales#ixzz2mSpFbZuZ
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dothedd
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NOVAVAX
Dec 3, 2013 20:23:21 GMT -5
Post by dothedd on Dec 3, 2013 20:23:21 GMT -5
Seeking Alpha Novavax's CEO Presents at Piper Jaffray HC 2013 Conference (Transcript) t.co/pKVrwM8rw1 $NVAX 2 Hours Ago ·
stocknews247 $NVAX - Novavaxs CEO Presents at Piper Jaffray HC 2013 Conference (Transcript) -> t.co/IN3M3Cd1m0 stock stocks NVAX 2 Hours Ago
Extreme Picks Emylers: $NVAX Up to date company activities and other impo t.co/ptANZSEVyz 2 Hours Ago WorldofMorons WTracker $NVAX Company News Novavax Inc. up 16% in premarket 6:52 a.m. Oct. 25, 2012 - Steve Gelsi Novavax gains 11% on t.co/eurti99GvQ 1 3 Hours Ago
ChartMill losing aftermarket stocks t.co/teDwVpgBfn $OVTI $CLDX $NVAX 3 Hours Ago · Comment · Reply · Retweet · Favorite
Anthony Fiedler As day closes, portfolio rebounded from earlier losses. $NVAX 4 Hours Ago
TickerTutor $NVAX Patience pays, y'all. Patience pays!!! 4 Hours Ago · who bought 10million shares of $NVAX in the last 90 seconds of the day?
3 Hours Ago Stock_theWizardofStocks $NVAX is getting spark behind it, will be at $5 possibly by Friday imo! 4 Hours Ago · LongShortSqueeze $NVAX is getting spark behind it, will be at $5 possibly by Friday imo! 4 Hours Ago Read more: www.nasdaq.com/symbol/nvax/stream#ixzz2mSsdP9d9
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dothedd
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NOVAVAX
Dec 3, 2013 20:30:20 GMT -5
Post by dothedd on Dec 3, 2013 20:30:20 GMT -5
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dothedd
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NOVAVAX
Dec 3, 2013 20:46:39 GMT -5
Post by dothedd on Dec 3, 2013 20:46:39 GMT -5
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dothedd
Senior Member
Joined: Dec 27, 2010 20:43:28 GMT -5
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NOVAVAX
Dec 3, 2013 21:15:09 GMT -5
Post by dothedd on Dec 3, 2013 21:15:09 GMT -5
Novavax announced in March 2011 that it had been awarded a contract valued at up to $179 million by the Office of Biomedical Advanced Research and Development Authority (BARDA) within the Office of the Assistant Secretary for Preparedness and Response at the U.S. Department of Health and Human Services (HHS) for the advanced clinical and manufacturing development of recombinant vaccines for the prevention of seasonal and pandemic influenza. During the contract’s 3-year base period, valued at $97 million, Novavax will continue to develop and manufacture its novel, clinical-stage, recombinant virus-like particle (VLP) influenza vaccines to address BARDA’s commitment to advancing recombinant-based technology and pandemic preparedness. The contract could be extended for an additional 24-month option period with $82 million in additional funding to build on the work Novavax accomplishes during the base period and to support manufacturing scale-up and licensure by the U.S. Food & Drug Administration (FDA).
During the contract’s base period, funded activities would include:
three (3) clinical trials utilizing Novavax’s pandemic influenza VLP vaccine candidate with adjuvants (including Novavax’s proprietary Novasome adjuvant); Phase II dose-ranging trial and Phase III registration trial utilizing Novavax’s seasonal influenza VLP vaccine candidate; and development of a manufacturing facility plan that has the capability to produce finished vaccine within twelve (12) weeks and at least 50 million doses within six (6) months of an influenza pandemic declaration. Novavax’s manufacturing facility plan will outline the design, construction, commissioning, qualification and validation of such a U.S.-based facility to produce recombinant seasonal and pandemic vaccines. Additional funded base period activities include vaccine product characterization, process development and scale–up of recombinant vaccine manufacturing including consistency lot manufacturing and lot-release assay development in support of the Phase III trial.
VIDEO: www.novavax.com/go.cfm?do=Page.View&pid=12
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dothedd
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Joined: Dec 27, 2010 20:43:28 GMT -5
Posts: 2,683
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NOVAVAX
Dec 5, 2013 18:00:36 GMT -5
Post by dothedd on Dec 5, 2013 18:00:36 GMT -5
DECEMBER 5, 2013 NVAX 4.04+0.03(+0.75%)Dec 5 4:00 PM EST
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dothedd
Senior Member
Joined: Dec 27, 2010 20:43:28 GMT -5
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NOVAVAX
Dec 5, 2013 18:39:36 GMT -5
Post by dothedd on Dec 5, 2013 18:39:36 GMT -5
Novavax: 5 Stocks Under $10 Set to Soar The Street: 5 Stocks Under $10 Set to Soar... BY Roberto Pedone|12/05/13
DELAFIELD, Wis. (Stockpickr) -- There isn't a day that goes by on Wall Street when certain stocks trading for $10 a share or less don't experience massive spikes higher. Traders savvy enough to follow the low-priced names and trade them with discipline and sound risk management are banking ridiculous coin on a regular basis.
One low-priced stock that's been on fire since I recently flagged it is clinical stage biopharmaceutical player Novavax (NVAX), which I highlighted in Nov. 21's "5 Stocks Under $10 Set to Soar" at $3.25 per share. I mentioned in that piece that shares of Novavax were uptrending over the last few weeks, with shares moving higher from its low of $2.68 to $3.27 a share. That move was quickly pushing NVAX within range of triggering a major breakout trade above some near-term overhead resistance levels at $3.39 to $3.50 a share.
Guess what happened? Shares of Novavax didn't take long to trigger that breakout, since the stock started to clear those overhead resistance levels the following week with strong upside volume flows. This stock has done nothing but uptrending since my article, with shares of NVAX tagging an intraday high today of $4.25 a share. That represents a gain of just over 30% in only a few weeks, but there might still be much more gains in store for NVAX. If this stock can maintain its uptrend, then we should see NVAX tag $5 a share very soon.
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dothedd
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Joined: Dec 27, 2010 20:43:28 GMT -5
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Post by dothedd on Jan 4, 2014 5:54:30 GMT -5
NVAX
5.31+0.10(1.92%)Jan 3 4:00 PMEST
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dothedd
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Joined: Dec 27, 2010 20:43:28 GMT -5
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NOVAVAX
Jan 15, 2014 15:30:33 GMT -5
Post by dothedd on Jan 15, 2014 15:30:33 GMT -5
Monday, January 13, 2014
8:02 am Novavax announces continuation of RSV Vaccine Partnership with PathBriefing.com (Mon, Jan 13)
Novavax:A Biotech Story Set To Double In 2014at Seeking Alpha (Mon, Jan 13) Novavax Announces Management Promotions to Support Expanded Clinical Activity in 2014GlobeNewswire (Mon, Jan 13)
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dothedd
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Joined: Dec 27, 2010 20:43:28 GMT -5
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NOVAVAX
Jan 15, 2014 15:31:14 GMT -5
Post by dothedd on Jan 15, 2014 15:31:14 GMT -5
Novavax Announces Continuation of RSV Vaccine Partnership With PATHGlobeNewswire (Mon, Jan 13)
ROCKVILLE, Md., Jan. 13, 2014 (GLOBE NEWSWIRE) -- Novavax, Inc. (NVAX) announced the continuation of their partnership with PATH to develop Novavax' RSV (respiratory syncytial virus) vaccine for maternal immunization. Under this amendment, PATH will provide Novavax approximately $3.5 million in funding to support the ongoing Phase II dose-confirmatory clinical trial in women of childbearing age, initiated in October 2013. Under this partnership, Novavax and PATH will also initiate planning activities for clinical development of the vaccine in low-resource countries.
Data from the ongoing Phase II clinical trial will provide additional evidence of the vaccine candidate's safety and establish the appropriate dose to be used in a follow-on clinical trial in pregnant women. By immunizing pregnant women, Novavax believes that high levels of protective maternal RSV antibodies will be transferred to their offspring through the placenta before birth, providing protection in early infancy when RSV infection is most dangerous.
Under this partnership, PATH and Novavax may elect to continue to collaborate on additional clinical trials to further develop Novavax' RSV vaccine for maternal immunization in low-resource countries. Novavax retains global rights to commercialize the product and will support PATH in its goal to make the product affordable and available in low-resource countries.
"PATH, an internationally recognized innovative global health organization, continues to support a key portion of the development expenses for our RSV vaccine candidate. We are gratified by PATH's continued funding of this vaccine development program, which has the potential to dramatically improve pediatric health worldwide," said Stanley C. Erck, President and CEO of Novavax.
"We are pleased to be working with Novavax to support the development of a maternal RSV vaccine that has the potential to protect infants in low-resource countries during the critical early months of life," said Dr. John Donnelly, director of PATH's RSV vaccine project.
About RSV
Respiratory syncytial virus (RSV) is one of the most common causes of lower respiratory tract infection among young children, both globally and in the United States. The majority of cases of severe RSV disease occur in otherwise healthy children. It is estimated that there are 64 million cases of RSV disease worldwide each year, resulting in 160,000 deaths. In the U.S., RSV causes as many as 172,000 annual hospitalizations among children younger than 5 years old, with the vast majority of these occurring in infants less than six months of age. Maternal immunization for the protection of young infants against infectious diseases has been successfully employed to eliminate 92% of neonatal tetanus cases globally, and in the U.S. is currently used to prevent whooping cough and influenza. Currently, there is no approved vaccine against RSV.
About Novavax
Novavax, Inc. (NVAX) is a clinical-stage biopharmaceutical company creating novel vaccines and vaccine adjuvants to address a broad range of infectious diseases worldwide. Using innovative proprietary recombinant protein nanoparticle vaccine technology, the company produces vaccine candidates to efficiently and effectively respond to both known and newly emergent diseases. Additional information about Novavax is available on the company's website, novavax.com.
About PATH
PATH is an international nonprofit organization that transforms global health through innovation. We take an entrepreneurial approach to developing and delivering high-impact, low-cost solutions, from lifesaving vaccines, drugs, diagnostics, and devices to collaborative programs with communities. Through our work in more than 70 countries, PATH and our partners empower people to achieve their full potential. For more information, please visit www.path.org.
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dothedd
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Joined: Dec 27, 2010 20:43:28 GMT -5
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NOVAVAX
Mar 10, 2014 21:21:04 GMT -5
Post by dothedd on Mar 10, 2014 21:21:04 GMT -5
Novavax Reports Fourth-Quarter and Year-End 2013 Financial Results and Initiation of Phase 1/2 Clinical Trial of its H7N9 Avian Influenza VLP Vaccine Candidate with Matrix-M™
Gaithersburg, MD (March 10, 2014) - Novavax, Inc. (Nasdaq: NVAX), a clinical-stage biopharmaceutical company focused on the discovery, development and commercialization of recombinant nanoparticle vaccines and adjuvants, today reported its financial results for the fourth quarter and year ended December 31, 2013 and announced the initiation of a Phase 1/2 clinical trial of its H7N9 avian influenza VLP vaccine candidate with its proprietary Matrix-M adjuvant. The trial is enrolling 610 healthy subjects to evaluate the safety and immunogenicity of this vaccine and adjuvant.
Novavax Business Highlights 2013 Achievements: Reported data from two RSV F-protein nanoparticle vaccine trials, one in 330 women of childbearing age and the other in 220 elderly subjects, demonstrating strong immunogenicity of the RSV vaccine candidate; Demonstrated in the RSV elderly subject trial that the vaccine could be administered concurrently with a seasonal influenza vaccine to elicit potentially protective levels of antibodies to both vaccine targets; Initiated our H7N9 avian influenza VLP vaccine candidate program in April and published the industry’s first H7N9 vaccine human clinical trial data showing highly protective levels of antibodies following vaccination in the December 26th issue of the New England Journal of Medicine; Acquired Novavax AB (previously Isconova AB) and its saponin-based adjuvant Matrix-M to support Novavax’ vaccine programs; and Completed a successful $100 million secondary stock offering.
2014 Recent Events: Extended the contract for Advanced Development of Recombinant Influenza Products and Pandemic Preparedness with HHS BARDA; and Initiated a U.S.-based Phase 1/2 clinical trial of H7N9 avian influenza VLP vaccine candidate with Matrix-M, enrolling 610 healthy adult subjects between 18 and 64 years old, under the Company’s HHS BARDA contract.
2014 Anticipated Events: Release of top-line data from the ongoing Phase 2 clinical trial of the RSV F protein nanoparticle vaccine candidate in women of childbearing age in the second quarter of 2014; Release of top-line data from the recently initiated Phase 1/2 clinical trial of the H7N9 avian influenza VLP vaccine candidate with Matrix-M in the second half of 2014; Initiate a Phase 2 clinical trial of our RSV F protein nanoparticle vaccine in pregnant women in the fourth quarter of 2014; and Initiate a Phase 2 clinical trial of our quadrivalent VLP seasonal influenza vaccine in the fourth quarter of 2014. “We made substantial progress in advancing our RSV and influenza vaccine development programs during 2013 and I believe 2014 holds the potential for even greater accomplishments across our entire pipeline,” said Stan Erck, president and CEO of Novavax, Inc. “Our rapid response to the emergence of an avian H7N9 influenza strain continues to demonstrate the power and flexibility of our vaccine and adjuvant technologies. This year we plan to report top-line results from our ongoing RSV and influenza studies, initiate our first RSV clinical trial in pregnant women and report top-line results from the first study of our H7N9 avian influenza vaccine candidate with our Matrix-M adjuvant. These will be important milestones for these programs for which I anticipate continued success in 2014.” Financial Results for the Fourth Quarter and Year Ended December 31, 2013 In connection with its acquisition on July 31, 2013, Novavax AB’s operations have been included in the company’s consolidated results of operations and financial position as of the acquisition date. Novavax reported a net loss of $14.1 million, or $0.07 per share, for the fourth quarter of 2013, compared to a net loss of $8.0 million, or $0.06 per share, for the fourth quarter of 2012. For the full year 2013, the net loss was $52.0 million, or $0.31 per share, compared to a net loss of $28.5 million, or $0.22 per share, for 2012. Novavax revenue in the fourth quarter of 2013 increased 92% to $8.7 million as compared to $4.6 million for the same period in 2012. The increase in revenue was primarily due to the HHS BARDA amendment relating to H7N9 manufacturing and other activities and the PATH amendment to support the company’s Phase 2 clinical trial in women of childbearing age. Research and development expenses increased 69% to $16.3 million in the fourth quarter of 2013, compared to $9.6 million for the same period in 2012, primarily as a result of increased costs relating to the company’s RSV and pandemic (H7N9) influenza clinical trials and higher employee-related costs. General and administrative expenses increased 65% to $4.1 million in the fourth quarter of 2013 as compared to $2.5 million for the same period in 2012, resulting primarily from Novavax AB’s expenses and higher professional fees.
As of December 31, 2013, the company had $133.1 million in cash and cash equivalents and investments compared to $50.3 million as of December 31, 2012. Net cash used in operating activities for 2013 was $45.4 million compared to $18.2 million for 2012. The increase in cash usage from the prior year was primarily due to higher research and development spending, including the company’s RSV and pandemic (H7N9) influenza clinical trials, as well as increased employee-related costs.
Conference Call Novavax management will host its quarterly conference call today at 4:30 p.m. EDT. The dial-in number for the conference call is 1 (877) 212-6076 (U.S. or Canada) or 1 (707) 287-9331 (international). 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 conference call will be available starting at 7:30 p.m. on March 10, 2014 until midnight May 1, 2014. To access the replay by telephone, dial 1 (855) 859-2056 (domestic) or 1 (404) 537-3406 (international) and use passcode 2459615. The replay will also be available as a webcast and can be found on the “Investor Info”/”Events” on the Novavax website.
About Novavax Novavax, Inc. (Nasdaq: NVAX) is a clinical-stage biopharmaceutical company creating novel vaccines and vaccine adjuvants to address a broad range of infectious diseases worldwide. Using innovative proprietary recombinant protein nanoparticle vaccine technology, the company produces vaccine candidates to efficiently and effectively respond to both known and newly emergent diseases. Novavax is involved in several international partnerships, including collaborations with Cadila Pharmaceuticals of India, LG Life Sciences of Korea and PATH, and recently acquired Isconova AB, a leading vaccine adjuvant company located in Sweden. Together, Novavax’ network supports its global commercialization strategy to create real and lasting change in the biopharmaceutical and vaccinology fields. Additional information about Novavax is available on the company’s website, novavax.com.
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dothedd
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Post by dothedd on Mar 21, 2014 15:08:30 GMT -5
Novavax HAS: 12 Completed Studies 3 Active, not recruiting 1 Recruiting
1 Completed Safety Study of Respiratory Syncytial Virus (RSV)-Fusion (F) Protein Particle Vaccine Condition: Respiratory Syncytial Virus Infections Interventions: Biological: RSV-F Particle Vaccine; Biological: Placebo
2 Completed A Study to Evaluate the Immune Response and Safety of a Seasonal Virus-Like Particle Influenza Vaccine in Healthy Young Adults Condition: Influenza Interventions: Biological: Novavax Quadrivalent vaccine; Biological: Novavax Trivalent vaccine; Biological: cTIV
3 Completed A/H5N1 Virus-Like Particle Antigen Dose Ranging Study With Adjuvant 1 Condition: Influenza (Pandemic) Interventions: Biological: Monovalent Avian Influenza VLP (H5N1); Biological: Monovalent Avian Influenza VLP (H5N1); Adjuvant; Biological: Saline placebo
4 Completed A/H5N1 Virus-Like Particle Antigen Dose Ranging Study With Adjuvant 2 Condition: Influenza (Pandemic) Interventions: Biological: Monovalent Avian Influenza VLP (H5N1); Biological: Monovalent Avian Influenza VLP (H5N1); Adjuvant; Biological: Saline Placebo
5 Completed Safety Study of Respiratory Syncytial Virus (RSV)-Fusion (F) Protein Particle Vaccine Condition: Respiratory Syncytial Virus Infections Interventions: Biological: RSV-F Particle Vaccine; Biological: Placebo
6 Completed RSV-F Vaccine and Influenza Vaccine Co-Administration Study in the Elderly Condition: Respiratory Syncytial Virus (RSV) Interventions: Biological: Low dose RSV-F Vaccine with Adjuvant (Day 0); Seasonal TIV (Day 0 & Day 28); Biological: Low dose RSV-F Vaccine without Adjuvant (Day 0); Seasonal TIV (Day 0 & day 28); Biological: High dose RSV-F Vaccine with Adjuvant (Day 0); Seasonal TIV (Day 0 & Day 28); Biological: High dose RSV-F Vaccine without Adjuvant (Day 0); Seasonal TIV (Day 0 & Day 28); Biological: Placebo (Day 0 & Day 28); Seasonal TIV (Day 0)
7 Completed Trial to Evaluate Safety and Immunogenicity of Trivalent Seasonal Influenza Virus-Like Particle (VLP) Vaccine (Recombinant) Condition: Seasonal Influenza Interventions: Biological: Influenza VLP Vaccine; Biological: Placebo
8 Completed RSV-F Vaccine Dose Ranging Study in Young Women Condition: Respiratory Syncytial Virus (RSV) Interventions: Biological: Low dose RSV-F Vaccine with Adjuvant; Biological: Low dose RSV-F Vaccine without Adjuvant; Biological: High dose RSV-F Vaccine with Adjuvant; Biological: High dose RSV-F Vaccine without Adjuvant; Biological: Low dose RSV-F Vaccine with Adjuvant [Bedside Mixing]; Biological: Placebo
9 Completed Evaluate the Safety and Immunogenicity of a Seasonal Influenza Virus-Like Particle (VLP) Vaccine in Older Adults Condition: Influenza Interventions: Biological: Influenza VLP Vaccine; Biological: TIV 10 Completed Evaluate the Safety and Immunogenicity of a Seasonal Influenza VLP Vaccine (Recombinant) in Healthy Adults Condition: Influenza Interventions: Biological: Influenza VLP Vaccine (recombinant); Biological: Placebo
11 Completed Safety, Reactogenicity and Immunogenicity of an H5N1 VLP Condition: Pandemic Influenza Interventions: Biological: H5N1 VLP Vaccine; Biological: Placebo
12 Completed Safety and Immunogenicity of an A (H1N1) 2009 Influenza Virus-like Particle (VLP) Vaccine Condition: Seasonal Influenza Interventions: Biological: Placebo; Biological: A/H1N1 2009 Influenza VLP Vaccine 1 Active, not recruiting RSV F Dose-Ranging Study in Women Condition: Respiratory Syncytial Virus Infections Interventions: Biological: Low dose RSV F Antigen; Biological: High dose RSV F Antigen; Biological: Dose 1 of Adjuvant; Biological: Dose 2 of Adjuvant; Biological: Dose 3 of Adjuvant; Biological: Dose 4 of Adjuvant; Biological: Placebo
2 Active, not recruiting A(H7N9) VLP Antigen Dose Ranging Study With Adjuvant 1 Condition: Avian Influenza Interventions: Biological: Monovalent Avian Influenza VLP (H7N9); Biological: Adjuvant 1; Biological: Placebo
3 Active, not recruiting RSV F Dose-Ranging Study in Women Condition: Respiratory Syncytial Virus Infections Interventions: Biological: Low dose RSV F Antigen; Biological: High dose RSV F Antigen; Biological: Dose 1 of Adjuvant; Biological: Dose 2 of Adjuvant; Biological: Dose 3 of Adjuvant; Biological: Dose 4 of Adjuvant; Biological: Placebo 1 Recruiting A(H7N9) VLP Antigen Dose-Ranging Study With Matrix-M1™ Adjuvant Condition: Influenza (Pandemic) Interventions: Biological: Monovalent Avian Influenza VLP (H7N9); Biological: Matrix-M1™ adjuvant; Biological: Placebo
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