|By Marketwired .||
|November 12, 2012 07:30 AM EST||
CONSHOHOCKEN, PA -- (Marketwire) -- 11/12/12 -- NuPathe Inc. (NASDAQ: PATH), a specialty pharmaceutical company focused on the development and commercialization of branded therapeutics for diseases of the central nervous system, today announced financial results for the quarter ended September 30, 2012, and recent operational highlights.
"The acceptance of our New Drug Application for Zecuity and the completion of our $28 million capital raise were important achievements for the company," said Armando Anido, chief executive officer of NuPathe. "We now have the financial resources to achieve our key objectives: to obtain approval for Zecuity, to secure commercial partners, and to conduct additional pre-launch activities for this valuable new migraine treatment."
Quarterly and Recent Highlights
- In July, NuPathe's New Drug Application (NDA) resubmission for its migraine patch, Zecuity (formerly known as NP101 and Zelrix), was accepted for filing by the U.S. Food and Drug Administration (FDA) and received a Prescription Drug User Fee Act (PDUFA) date of January 17, 2013, which is the target date for the FDA to complete its review of the NDA.
- In July, Armando Anido was appointed chief executive officer and a member of NuPathe's board of directors. Mr. Anido has more than 30 years of executive, operational and commercial leadership experience in the biopharmaceutical industry. Most recently, he served as president and CEO of Auxilium Pharmaceuticals (NASDAQ: AUXL), where under his leadership, sales grew from $42 million in 2005 to more than $260 million in 2011 and market capitalization increased from $200 million to more than $900 million.
- In August and September, NuPathe entered into two separate modifications to its Term Loan Facility, which, among other things, reduced the minimum unrestricted cash balance that the Company is required to maintain from $3 million to $1 million, and temporarily reduced the monthly principal payments due under the Term Loan Facility to $0.23 million through June 30, 2013, after which the principal balance will amortize straight-line through June 2014.
- In October, NuPathe completed the sale of $28 million of securities resulting in approximately $26.3 million of net proceeds. The securities were sold as units, each consisting of 1/1,000th of a share of newly designated Series A preferred stock and a warrant to purchase one share of the Company's common stock. The purchase price per unit was $2.00.
- In conjunction with the financing, James A. Datin, Executive Vice President and Managing Director, and Brian J. Sisko, Senior Vice President and General Counsel, both from Safeguard Scientifics, Inc. (NYSE: SFE), along with Richard S. Kollender, Partner at Quaker Partners Management, L.P., were appointed to NuPathe's board of directors. Jeanne Cunicelli, Investment Partner at Bay City Capital LLC, and Dr. Gary Kurtzman, Senior Vice President and Managing Director at Safeguard, resigned from the board.
- Also in conjunction with the financing, NuPathe undertook cost containment measures to focus its expenditures on obtaining FDA approval of Zecuity, securing commercial partners and conducting additional pre-launch activities.
Third Quarter 2012 Financial Results
NuPathe reported a net loss of $6.2 million for the third quarter of 2012, compared with a net loss of $7.4 million for the third quarter of 2011.
Research and development expenses were $2.2 million in the third quarter of 2012, compared with $3.9 million in the third quarter of 2011. The decrease was largely attributable to reduced spending related to Zecuity, NP201 and NP202 during the 2012 period, combined with the fact that the 2011 period included higher CMC expenses related to the purchase and manufacture of clinical supplies for Zecuity. Selling, general and administrative expenses were $3.5 million in the third quarter of 2012, compared with $3.0 million for the same period in 2011. The increase was primarily attributable to separation expenses accrued in conjunction with the resignation of the former CEO as well as the elimination of 15 full-time equivalent positions announced in September, partially offset by curtailed activities in the area of commercial operations.
Net cash used in operating activities for the nine months ended September 30, 2012, was $15.1 million, primarily the result of spending for normal operating activities and development and regulatory expenses for the preparation of the resubmission of the NDA for Zecuity. During this period NuPathe also used $0.3 million of cash in investing activities as well as $6.4 million of cash for financing activities primarily related to contractual debt repayments. During the nine months ended September 30, 2011, NuPathe used $14.7 million for operating activities as well as $3.5 million for investing activities for the funding of commercial manufacturing equipment for the migraine patch. Additionally, during the 2011 period NuPathe received net proceeds of $9.3 million from financing activities, primarily from proceeds received under the Company's credit facility, offset partially by scheduled debt repayments.
As of September 30, 2012, NuPathe had $1.3 million in cash and cash equivalents and a working capital deficit of $7.6 million, compared with $23.1 million in cash and cash equivalents and working capital of $11.0 million as of December 31, 2011. Management estimates that the Company's current cash and cash equivalents as of September 30, 2012, plus the approximately $26.3 million in net proceeds from the October 2012 financing discussed above, will be sufficient to fund operations, debt service and interest obligations into the fourth quarter of 2013.
Company to Host Conference Call
NuPathe will host a conference call today, November 12, 2012, at 8:30 a.m. EST to discuss the Company's financial results for the quarter ended September 30, 2012, and recent operational highlights. A question and answer session will follow NuPathe's remarks. To participate on the live call, please dial 888-359-3627 (domestic) or +1-719-457-2727 (international), and provide the participant passcode 8657634, approximately 10 minutes ahead of the start of the call. A replay of the call will be available for 90 days within a few hours after the call ends and can be accessed by dialing 888-203-1112 (domestic) or +1-719-457-0820 (international), with the passcode 8657634.
A live audio webcast of the call will be available via the "Investor Relations" page of the NuPathe website, www.nupathe.com. Please log on through NuPathe's website approximately 10 minutes prior to the scheduled start time. A replay of the webcast will also be archived on the Company's website for 90 days following the call.
Zecuity is an active, single-use, transdermal patch in development for the treatment of migraine. If approved, it will be the first transdermal patch for the treatment of migraine. The patch actively delivers sumatriptan, the most widely prescribed migraine medication. In three clinical trials involving more than 10,000 applications, Zecuity offered patients fast onset and sustained relief of debilitating migraine symptoms including headache pain and migraine-related nausea (MRN) and vomiting. Because Zecuity delivers sumatriptan transdermally, it may be an attractive treatment option for many frequent MRN sufferers and those patients who experience gastroparesis, a slowing of gastric absorption. The patch utilizes SmartRelief, NuPathe's proprietary transdermal delivery technology that allows the rapid yet tightly controlled transport of medication through the skin using a process called iontophoresis. As a result, in Zecuity clinical trials there was a low incidence of triptan sensations that include chest tightness, flushing and feelings of pressure and numbness.
About Migraine and Migraine-Related Nausea and Vomiting
Migraine is a neurological disorder that affects approximately 30 million adults in the U.S.(1) In addition to a headache pain, most migraine patients suffer from one or more significant gastrointestinal problems, including nausea, vomiting, and gastroparesis. Approximately eight million diagnosed migraine sufferers experience MRN in greater than 50 percent of their migraines.(2) These frequent-MRN sufferers are less likely to achieve headache relief with oral triptans(2,3) and are less satisfied with their current migraine medications.(4) They experience more medication-related interference in several aspects of life, including their ability to work and spend time with family.(4) These patients also generate increased direct medical costs as a result of their five-fold increase in emergency room and urgent care visits and eight-fold increase in overnight hospital stay costs.(5) In addition, approximately 3.4 million diagnosed migraine patients vomit during a majority of their migraines, while approximately 1.5 million patients vomit during every migraine.(1,6) Some migraine patients also experience gastroparesis, which may affect a patient's response to oral medications.(7)
NuPathe Inc. is a specialty pharmaceutical company focused on innovative neuroscience solutions for diseases of the central nervous system including neurological and psychiatric disorders. NuPathe's lead product candidate, Zecuity (previously referred to as Zelrix or NP101) is an active, single-use, transdermal sumatriptan patch being developed for the treatment of migraine. In addition to Zecuity, NuPathe has two proprietary product candidates based on its LAD, or Long-Acting Delivery, biodegradable implant technology that allows delivery of therapeutic levels of medication over a period of months with a single dose. NP201, for the continuous symptomatic treatment of Parkinson's disease, utilizes a leading FDA-approved dopamine agonist, ropinirole, and is being developed to provide up to two months of continuous delivery. NP202, for the long-term treatment of schizophrenia and bipolar disorder, is being developed to address the long-standing problem of patient noncompliance by providing three months of continuous delivery of risperidone, an atypical antipsychotic. NuPathe is actively seeking partnerships to maximize the commercial potential for its product candidates in the U.S. and territories throughout the world.
For more information about NuPathe, please visit our website and our blog at www.nupathe.com. You can also follow us on StockTwits (stocktwits.nupathe.com), Twitter (twitter.nupathe.com), SlideShare (slideshare.nupathe.com) and LinkedIn (linkedin.nupathe.com).
Cautionary Note Regarding Forward-Looking Statements
This press release contains "forward-looking statements" within the meaning of the Private Securities Litigation Reform Act of 1995. All statements that are not historical facts are hereby identified as forward-looking statements for this purpose and include, among others, statements relating to: timing of the completion of the FDA's review of our NDA for Zecuity; the approval and launch of Zecuity; pre-launch activities for Zecuity; partnering plans for our product candidates; the potential benefits of, and commercial opportunity for, our product candidates; the sufficiency of our cash and cash equivalents to fund debt service and interest obligations and continue operations into the fourth quarter of 2013; and other statements relating to our plans, objectives, expectations and beliefs regarding our future operations, performance or financial condition and other future events.
Forward-looking statements are based upon our current expectations, plans and beliefs and are subject to a number of risks, uncertainties, assumptions and other factors that could cause actual results and events to differ materially and adversely from those indicated by such statements including, among others: our ability to obtain FDA approval of Zecuity; the extent to which the FDA may request or require additional information, studies or redesign of Zecuity and the costs and time required to complete such activities; our ability to obtain partners for our product candidates; our ability to obtain additional capital on a timely basis and on agreeable terms to continue as a going concern; varying interpretation of trial, study and market data; and the other factors discussed in our Annual Report on Form 10-K for the year ended December 31, 2011 and in our Quarterly Report on Form 10-Q for the quarterly period ended September 30, 2012, under the caption "Risk Factors" and elsewhere in such reports, which are available on our website at www.nupathe.com in the "Investor Relations -- SEC Filings" section. While we may update certain forward-looking statements and Risk factors from time to time, we specifically disclaims any obligation to do so, whether as a result of new information, future developments or otherwise. You are cautioned not to place undue reliance on any forward-looking statements.
(1.) Lipton, R. Prevalence and Burden of Migraine in the United States: Data from the American Migraine Study II. Headache 2001 41:646-657 and US Census data (2010).
(2.) Diener et al. Predicting the response to sumatriptan, the sumatriptan naratriptan aggregate database. Neurology 2004;63:520-524.
(3.) Diener et al. Identification of negative predictors of pain-free response to triptans: analysis of the eletriptan database. Cephalalgia 2007, 28, 35-40.
(4.) Lipton, R. Data presented at the 53rd Annual Scientific Meeting of the American Headache Society (AHS), June 2011.
(5.) Lipton et al. Data presented at the Academy of Managed Care Pharmacy's 2011 Educational Conference, October 2011.
(6.) Silberstein, S. Migraine symptoms: results of a survey of self-reported migraineurs. Headache 1995;35:387-396.
(7.) Ferrari et al. Oral triptans (serotonin 5-HT1B/1D agonists) in acute migraine treatment: a meta-analysis of 53 trials. Lancet 2001; 358: 1668-75.
NUPATHE INC. (A Development-Stage Company) Statements of Operations (In thousands, except share and per share amounts) (Unaudited) Three Months Ended Nine Months Ended September 30, September 30, -------------------------- -------------------------- 2012 2011 2012 2011 ------------ ------------ ------------ ------------ Operating expenses: Research and development $ 2,220 $ 3,927 $ 9,033 $ 9,204 Selling, general and administrative 3,525 3,010 8,332 7,510 ------------ ------------ ------------ ------------ Total operating expenses 5,745 6,937 17,365 16,714 ------------ ------------ ------------ ------------ Loss from operations (5,745) (6,937) (17,365) (16,714) Interest income 2 17 17 58 Interest expense (446) (522) (1,293) (974) ------------ ------------ ------------ ------------ Net loss $ (6,189) $ (7,442) $ (18,641) $ (17,630) ============ ============ ============ ============ Basic and diluted net loss per common share $ (0.42) $ (0.51) $ (1.26) $ (1.21) ============ ============ ============ ============ Weighted average basic and diluted common shares outstanding 14,752,214 14,670,247 14,740,578 14,595,598 ============ ============ ============ ============ NUPATHE INC. (A Development-Stage Company) Balance Sheet Data (In thousands) (Unaudited) September 30, December 31, 2012 2011 -------------- -------------- Cash and cash equivalents $ 1,277 $ 23,059 Working capital (deficit) (7,614) 10,995 Total assets 9,702 30,849 Long-term debt 4,100 5,481 Total stockholders' equity (deficit) (4,169) 12,971
Almost everyone sees the potential of Internet of Things but how can businesses truly unlock that potential. The key will be in the ability to discover business insight in the midst of an ocean of Big Data generated from billions of embedded devices via Systems of Discover. Businesses will also need to ensure that they can sustain that insight by leveraging the cloud for global reach, scale and elasticity.
Jan. 25, 2015 01:00 PM EST Reads: 3,722
SYS-CON Media announced that Cisco, a worldwide leader in IT that helps companies seize the opportunities of tomorrow, has launched a new ad campaign in Cloud Computing Journal. The ad campaign, a webcast titled 'Is Your Data Center Ready for the Application Economy?', focuses on the latest data center networking technologies, including SDN or ACI, and how customers are using SDN and ACI in their organizations to achieve business agility. The Cisco webcast is available on-demand.
Jan. 25, 2015 12:00 PM EST Reads: 1,112
“The age of the Internet of Things is upon us,” stated Thomas Svensson, senior vice-president and general manager EMEA, ThingWorx, “and working with forward-thinking companies, such as Elisa, enables us to deploy our leading technology so that customers can profit from complete, end-to-end solutions.” ThingWorx, a PTC® (Nasdaq: PTC) business and Internet of Things (IoT) platform provider, announced on Monday that Elisa, Finnish provider of mobile and fixed broadband subscriptions, will deploy ThingWorx® platform technology to enable a new Elisa IoT service in Finland and Estonia.
Jan. 25, 2015 11:00 AM EST Reads: 1,422
Advanced Persistent Threats (APTs) are increasing at an unprecedented rate. The threat landscape of today is drastically different than just a few years ago. Attacks are much more organized and sophisticated. They are harder to detect and even harder to anticipate. In the foreseeable future it's going to get a whole lot harder. Everything you know today will change. Keeping up with this changing landscape is already a daunting task. Your organization needs to use the latest tools, methods and expertise to guard against those threats. But will that be enough? In the foreseeable future attacks w...
Jan. 25, 2015 11:00 AM EST Reads: 2,826
As enterprises move to all-IP networks and cloud-based applications, communications service providers (CSPs) – facing increased competition from over-the-top providers delivering content via the Internet and independently of CSPs – must be able to offer seamless cloud-based communication and collaboration solutions that can scale for small, midsize, and large enterprises, as well as public sector organizations, in order to keep and grow market share. The latest version of Oracle Communications Unified Communications Suite gives CSPs the capability to do just that. In addition, its integration ...
Jan. 25, 2015 11:00 AM EST Reads: 2,764
SYS-CON Events announced today that ActiveState, the leading independent Cloud Foundry and Docker-based PaaS provider, has been named “Silver Sponsor” of SYS-CON's DevOps Summit New York, which will take place June 9-11, 2015, at the Javits Center in New York City, NY. ActiveState believes that enterprises gain a competitive advantage when they are able to quickly create, deploy and efficiently manage software solutions that immediately create business value, but they face many challenges that prevent them from doing so. The Company is uniquely positioned to help address these challenges thro...
Jan. 25, 2015 11:00 AM EST Reads: 1,724
From telemedicine to smart cars, digital homes and industrial monitoring, the explosive growth of IoT has created exciting new business opportunities for real time calls and messaging. In his session at @ThingsExpo, Ivelin Ivanov, CEO and Co-Founder of Telestax, shared some of the new revenue sources that IoT created for Restcomm – the open source telephony platform from Telestax. Ivelin Ivanov is a technology entrepreneur who founded Mobicents, an Open Source VoIP Platform, to help create, deploy, and manage applications integrating voice, video and data. He is the co-founder of TeleStax, a...
Jan. 25, 2015 10:45 AM EST Reads: 2,870
Today’s enterprise is being driven by disruptive competitive and human capital requirements to provide enterprise application access through not only desktops, but also mobile devices. To retrofit existing programs across all these devices using traditional programming methods is very costly and time consuming – often prohibitively so. In his session at @ThingsExpo, Jesse Shiah, CEO, President, and Co-Founder of AgilePoint Inc., discussed how you can create applications that run on all mobile devices as well as laptops and desktops using a visual drag-and-drop application – and eForms-buildi...
Jan. 25, 2015 10:45 AM EST Reads: 2,355
We certainly live in interesting technological times. And no more interesting than the current competing IoT standards for connectivity. Various standards bodies, approaches, and ecosystems are vying for mindshare and positioning for a competitive edge. It is clear that when the dust settles, we will have new protocols, evolved protocols, that will change the way we interact with devices and infrastructure. We will also have evolved web protocols, like HTTP/2, that will be changing the very core of our infrastructures. At the same time, we have old approaches made new again like micro-services...
Jan. 25, 2015 10:30 AM EST Reads: 2,212
Disruptive macro trends in technology are impacting and dramatically changing the "art of the possible" relative to supply chain management practices through the innovative use of IoT, cloud, machine learning and Big Data to enable connected ecosystems of engagement. Enterprise informatics can now move beyond point solutions that merely monitor the past and implement integrated enterprise fabrics that enable end-to-end supply chain visibility to improve customer service delivery and optimize supplier management. Learn about enterprise architecture strategies for designing connected systems tha...
Jan. 25, 2015 10:00 AM EST Reads: 2,798
SYS-CON Events announced today that CodeFutures, a leading supplier of database performance tools, has been named a “Sponsor” of SYS-CON's 16th International Cloud Expo®, which will take place on June 9–11, 2015, at the Javits Center in New York, NY. CodeFutures is an independent software vendor focused on providing tools that deliver database performance tools that increase productivity during database development and increase database performance and scalability during production.
Jan. 25, 2015 10:00 AM EST Reads: 1,468
The Internet of Things is a misnomer. That implies that everything is on the Internet, and that simply should not be - especially for things that are blurring the line between medical devices that stimulate like a pacemaker and quantified self-sensors like a pedometer or pulse tracker. The mesh of things that we manage must be segmented into zones of trust for sensing data, transmitting data, receiving command and control administrative changes, and peer-to-peer mesh messaging. In his session at @ThingsExpo, Ryan Bagnulo, Solution Architect / Software Engineer at SOA Software, focused on desi...
Jan. 25, 2015 10:00 AM EST Reads: 2,013
"For over 25 years we have been working with a lot of enterprise customers and we have seen how companies create applications. And now that we have moved to cloud computing, mobile, social and the Internet of Things, we see that the market needs a new way of creating applications," stated Jesse Shiah, CEO, President and Co-Founder of AgilePoint Inc., in this SYS-CON.tv interview at 15th Cloud Expo, held Nov 4–6, 2014, at the Santa Clara Convention Center in Santa Clara, CA.
Jan. 25, 2015 09:30 AM EST Reads: 2,068
Things are being built upon cloud foundations to transform organizations. This CEO Power Panel at 15th Cloud Expo, moderated by Roger Strukhoff, Cloud Expo and @ThingsExpo conference chair, addressed the big issues involving these technologies and, more important, the results they will achieve. Rodney Rogers, chairman and CEO of Virtustream; Brendan O'Brien, co-founder of Aria Systems, Bart Copeland, president and CEO of ActiveState Software; Jim Cowie, chief scientist at Dyn; Dave Wagstaff, VP and chief architect at BSQUARE Corporation; Seth Proctor, CTO of NuoDB, Inc.; and Andris Gailitis, C...
Jan. 25, 2015 09:00 AM EST Reads: 2,362
Recurring revenue models are great for driving new business in every market sector, but they are complex and need to be effectively managed to maximize profits. How you handle the range of options for pricing, co-terming and proration will ultimately determine the fate of your bottom line. In his session at 15th Cloud Expo, Brendan O'Brien, Co-founder at Aria Systems, session examined: How time impacts recurring revenue How to effectively handle customer plan changes The range of pricing and packaging options to consider
Jan. 25, 2015 09:00 AM EST Reads: 2,380
Code Halos - aka "digital fingerprints" - are the key organizing principle to understand a) how dumb things become smart and b) how to monetize this dynamic. In his session at @ThingsExpo, Robert Brown, AVP, Center for the Future of Work at Cognizant Technology Solutions, outlined research, analysis and recommendations from his recently published book on this phenomena on the way leading edge organizations like GE and Disney are unlocking the Internet of Things opportunity and what steps your organization should be taking to position itself for the next platform of digital competition.
Jan. 25, 2015 02:00 AM EST Reads: 2,647
The Industrial Internet revolution is now underway, enabled by connected machines and billions of devices that communicate and collaborate. The massive amounts of Big Data requiring real-time analysis is flooding legacy IT systems and giving way to cloud environments that can handle the unpredictable workloads. Yet many barriers remain until we can fully realize the opportunities and benefits from the convergence of machines and devices with Big Data and the cloud, including interoperability, data security and privacy.
Jan. 25, 2015 01:45 AM EST Reads: 2,249
In their session at @ThingsExpo, Shyam Varan Nath, Principal Architect at GE, and Ibrahim Gokcen, who leads GE's advanced IoT analytics, focused on the Internet of Things / Industrial Internet and how to make it operational for business end-users. Learn about the challenges posed by machine and sensor data and how to marry it with enterprise data. They also discussed the tips and tricks to provide the Industrial Internet as an end-user consumable service using Big Data Analytics and Industrial Cloud.
Jan. 25, 2015 01:00 AM EST Reads: 2,454
SYS-CON Media announced that Splunk, a provider of the leading software platform for real-time Operational Intelligence, has launched an ad campaign on Big Data Journal. Splunk software and cloud services enable organizations to search, monitor, analyze and visualize machine-generated big data coming from websites, applications, servers, networks, sensors and mobile devices. The ads focus on delivering ROI - how improved uptime delivered $6M in annual ROI, improving customer operations by mining large volumes of unstructured data, and how data tracking delivers uptime when it matters most.
Jan. 25, 2015 12:30 AM EST Reads: 3,377
IoT is still a vague buzzword for many people. In his session at @ThingsExpo, Mike Kavis, Vice President & Principal Cloud Architect at Cloud Technology Partners, discussed the business value of IoT that goes far beyond the general public's perception that IoT is all about wearables and home consumer services. He also discussed how IoT is perceived by investors and how venture capitalist access this space. Other topics discussed were barriers to success, what is new, what is old, and what the future may hold. Mike Kavis is Vice President & Principal Cloud Architect at Cloud Technology Pa...
Jan. 24, 2015 06:15 PM EST Reads: 3,735