|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
The 4th International Internet of @ThingsExpo, co-located with the 17th International Cloud Expo - to be held November 3-5, 2015, at the Santa Clara Convention Center in Santa Clara, CA - announces that its Call for Papers is open. The Internet of Things (IoT) is the biggest idea since the creation of the Worldwide Web more than 20 years ago.
May. 24, 2015 09:00 AM EDT Reads: 1,325
"People are a lot more knowledgeable about APIs now. There are two types of people who work with APIs - IT people who want to use APIs for something internal and the product managers who want to do something outside APIs for people to connect to them," explained Roberto Medrano, Executive Vice President at SOA Software, in this SYS-CON.tv interview at Cloud Expo, held Nov 4–6, 2014, at the Santa Clara Convention Center in Santa Clara, CA.
May. 24, 2015 08:30 AM EDT Reads: 4,031
The 17th International Cloud Expo has announced that its Call for Papers is open. 17th International Cloud Expo, to be held November 3-5, 2015, at the Santa Clara Convention Center in Santa Clara, CA, brings together Cloud Computing, APM, APIs, Microservices, Security, Big Data, Internet of Things, DevOps and WebRTC to one location. With cloud computing driving a higher percentage of enterprise IT budgets every year, it becomes increasingly important to plant your flag in this fast-expanding business opportunity. Submit your speaking proposal today!
May. 24, 2015 08:00 AM EDT Reads: 4,032
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.
May. 24, 2015 06:30 AM EDT Reads: 5,413
The explosion of connected devices / sensors is creating an ever-expanding set of new and valuable data. In parallel the emerging capability of Big Data technologies to store, access, analyze, and react to this data is producing changes in business models under the umbrella of the Internet of Things (IoT). In particular within the Insurance industry, IoT appears positioned to enable deep changes by altering relationships between insurers, distributors, and the insured. In his session at @ThingsExpo, Michael Sick, a Senior Manager and Big Data Architect within Ernst and Young's Financial Servi...
May. 24, 2015 05:00 AM EDT Reads: 4,583
17th Cloud Expo, taking place Nov 3-5, 2015, at the Santa Clara Convention Center in Santa Clara, CA, will feature technical sessions from a rock star conference faculty and the leading industry players in the world. Cloud computing is now being embraced by a majority of enterprises of all sizes. Yesterday's debate about public vs. private has transformed into the reality of hybrid cloud: a recent survey shows that 74% of enterprises have a hybrid cloud strategy. Meanwhile, 94% of enterprises are using some form of XaaS – software, platform, and infrastructure as a service.
May. 24, 2015 05:00 AM EDT Reads: 2,113
Sensor-enabled things are becoming more commonplace, precursors to a larger and more complex framework that most consider the ultimate promise of the IoT: things connecting, interacting, sharing, storing, and over time perhaps learning and predicting based on habits, behaviors, location, preferences, purchases and more. In his session at @ThingsExpo, Tom Wesselman, Director of Communications Ecosystem Architecture at Plantronics, will examine the still nascent IoT as it is coalescing, including what it is today, what it might ultimately be, the role of wearable tech, and technology gaps stil...
May. 24, 2015 05:00 AM EDT Reads: 4,182
The Workspace-as-a-Service (WaaS) market will grow to $6.4B by 2018. In his session at 16th Cloud Expo, Seth Bostock, CEO of IndependenceIT, will begin by walking the audience through the evolution of Workspace as-a-Service, where it is now vs. where it going. To look beyond the desktop we must understand exactly what WaaS is, who the users are, and where it is going in the future. IT departments, ISVs and service providers must look to workflow and automation capabilities to adapt to growing demand and the rapidly changing workspace model.
May. 24, 2015 04:30 AM EDT Reads: 3,054
Since 2008 and for the first time in history, more than half of humans live in urban areas, urging cities to become “smart.” Today, cities can leverage the wide availability of smartphones combined with new technologies such as Beacons or NFC to connect their urban furniture and environment to create citizen-first services that improve transportation, way-finding and information delivery. In her session at @ThingsExpo, Laetitia Gazel-Anthoine, CEO of Connecthings, will focus on successful use cases.
May. 24, 2015 04:00 AM EDT Reads: 4,739
One of the biggest impacts of the Internet of Things is and will continue to be on data; specifically data volume, management and usage. Companies are scrambling to adapt to this new and unpredictable data reality with legacy infrastructure that cannot handle the speed and volume of data. In his session at @ThingsExpo, Don DeLoach, CEO and president of Infobright, will discuss how companies need to rethink their data infrastructure to participate in the IoT, including: Data storage: Understanding the kinds of data: structured, unstructured, big/small? Analytics: What kinds and how responsiv...
May. 24, 2015 04:00 AM EDT Reads: 4,282
Building low-cost wearable devices can enhance the quality of our lives. In his session at Internet of @ThingsExpo, Sai Yamanoor, Embedded Software Engineer at Altschool, provided an example of putting together a small keychain within a $50 budget that educates the user about the air quality in their surroundings. He also provided examples such as building a wearable device that provides transit or recreational information. He then reviewed the resources available to build wearable devices at home including open source hardware, the raw materials required and the options available to power s...
May. 24, 2015 03:30 AM EDT Reads: 3,817
With major technology companies and startups seriously embracing IoT strategies, now is the perfect time to attend @ThingsExpo in Silicon Valley. Learn what is going on, contribute to the discussions, and ensure that your enterprise is as "IoT-Ready" as it can be! Internet of @ThingsExpo, taking place Nov 3-5, 2015, at the Santa Clara Convention Center in Santa Clara, CA, is co-located with 17th Cloud Expo and will feature technical sessions from a rock star conference faculty and the leading industry players in the world. The Internet of Things (IoT) is the most profound change in personal an...
May. 24, 2015 03:00 AM EDT Reads: 2,329
DevOps tends to focus on the relationship between Dev and Ops, putting an emphasis on the ops and application infrastructure. But that’s changing with microservices architectures. In her session at DevOps Summit, Lori MacVittie, Evangelist for F5 Networks, will focus on how microservices are changing the underlying architectures needed to scale, secure and deliver applications based on highly distributed (micro) services and why that means an expansion into “the network” for DevOps.
May. 24, 2015 03:00 AM EDT Reads: 2,813
How do APIs and IoT relate? The answer is not as simple as merely adding an API on top of a dumb device, but rather about understanding the architectural patterns for implementing an IoT fabric. There are typically two or three trends: Exposing the device to a management framework Exposing that management framework to a business centric logic Exposing that business layer and data to end users. This last trend is the IoT stack, which involves a new shift in the separation of what stuff happens, where data lives and where the interface lies. For instance, it's a mix of architectural styles ...
May. 24, 2015 03:00 AM EDT Reads: 5,620
The 3rd International @ThingsExpo, co-located with the 16th International Cloud Expo – to be held June 9-11, 2015, at the Javits Center in New York City, NY – is now accepting Hackathon proposals. Hackathon sponsorship benefits include general brand exposure and increasing engagement with the developer ecosystem. At Cloud Expo 2014 Silicon Valley, IBM held the Bluemix Developer Playground on November 5 and ElasticBox held the DevOps Hackathon on November 6. Both events took place on the expo floor. The Bluemix Developer Playground, for developers of all levels, highlighted the ease of use of...
May. 24, 2015 02:30 AM EDT Reads: 4,186
We’re no longer looking to the future for the IoT wave. It’s no longer a distant dream but a reality that has arrived. It’s now time to make sure the industry is in alignment to meet the IoT growing pains – cooperate and collaborate as well as innovate. In his session at @ThingsExpo, Jim Hunter, Chief Scientist & Technology Evangelist at Greenwave Systems, will examine the key ingredients to IoT success and identify solutions to challenges the industry is facing. The deep industry expertise behind this presentation will provide attendees with a leading edge view of rapidly emerging IoT oppor...
May. 24, 2015 02:30 AM EDT Reads: 4,711
Connected devices and the Internet of Things are getting significant momentum in 2014. In his session at Internet of @ThingsExpo, Jim Hunter, Chief Scientist & Technology Evangelist at Greenwave Systems, examined three key elements that together will drive mass adoption of the IoT before the end of 2015. The first element is the recent advent of robust open source protocols (like AllJoyn and WebRTC) that facilitate M2M communication. The second is broad availability of flexible, cost-effective storage designed to handle the massive surge in back-end data in a world where timely analytics is e...
May. 24, 2015 02:00 AM EDT Reads: 6,035
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...
May. 24, 2015 01:30 AM EDT Reads: 5,238
SYS-CON Events announced today that Gridstore™, the leader in hyper-converged infrastructure purpose-built to optimize Microsoft workloads, will exhibit at SYS-CON's 16th International Cloud Expo®, which will take place on June 9-11, 2015, at the Javits Center in New York City, NY. Gridstore™ is the leader in hyper-converged infrastructure purpose-built for Microsoft workloads and designed to accelerate applications in virtualized environments. Gridstore’s hyper-converged infrastructure is the industry’s first all flash version of HyperConverged Appliances that include both compute and storag...
May. 24, 2015 01:15 AM EDT Reads: 6,038
For years, we’ve relied too heavily on individual network functions or simplistic cloud controllers. However, they are no longer enough for today’s modern cloud data center. Businesses need a comprehensive platform architecture in order to deliver a complete networking suite for IoT environment based on OpenStack. In his session at @ThingsExpo, Dhiraj Sehgal from PLUMgrid will discuss what a holistic networking solution should really entail, and how to build a complete platform that is scalable, secure, agile and automated.
May. 24, 2015 01:00 AM EDT Reads: 4,099