NuPathe Announces Second Quarter 2013 Financial Results and Recent Operational Highlights

NuPathe Announces Second Quarter 2013 Financial Results and Recent Operational 
Highlights 
Commercial & Manufacturing Preparations Advance for 4Q Launch of
ZECUITY 
CONSHOHOCKEN, PA -- (Marketwired) -- 08/08/13 --  NuPathe Inc.
(NASDAQ: PATH) today announced financial results for the quarter
ended June 30, 2013, as well as recent operational highlights. 
"NuPathe achieved significant progress in commercial and
manufacturing preparations to support the fourth quarter launch of
our first product, ZECUITY, while simultaneously advancing dialogues
with potential partners to extend our reach," said Armando Anido,
chief executive officer of NuPathe. "Data presented at the recent
International Headache Congress, the premier headache scientific
meeting, reinforced to our key audiences that ZECUITY is an
easy-to-use treatment option that may benefit millions of migraine
patients who frequently suffer from migraine-related nausea along
with headache pain." 
Quarterly and Recent Highlights 


 
--  NuPathe accomplished a number of key commercial objectives
    year-to-date in preparation for the launch of ZECUITY(R)
    (sumatriptan iontophoretic transdermal system) in the fourth quarter
    of 2013. The Company selected its sales leadership and managed care
    teams as well as a third-party logistics provider and its advertising
    and public relations agencies of record. In addition, a recruiting
    plan is in place for the field sales team to support the launch.
--  The Company advanced commercial manufacturing, including the
    completion of almost all of the process qualification activities, the
    initiation of process validation for critical manufacturing operations
    and the finalization of delivery schedules for key assemblies and
    components.
--  In June, NuPathe presented new data on ZECUITY at the International
    Headache Congress (IHC) in Boston. A post-hoc analysis showed that
    ZECUITY was efficacious in treating migraine headache pain and
    associated symptoms regardless of the presence of nausea prior to
    treatment. Another post-hoc analysis showed that patients treated with
    a placebo patch were more likely to have treatment-emergent nausea
    than those treated with ZECUITY. In addition, a third data
    presentation showed
 that migraine patients could correctly and easily
    assemble, apply and activate ZECUITY during an attack.
--  In May, the United States Patent and Trademark Office (USPTO) issued a
    notice of allowance for U.S. Patent application 13/105,585 entitled
    "Transdermal Methods and Systems for the Delivery of Anti-Migraine
    Compounds." This patent, which is now issued, will provide additional
    protection for ZECUITY and is the fifth patent covering ZECUITY to be
    listed in the U.S. Food and Drug Administration's (FDA) Orange Book.
--  In April and May, the USPTO issued notices of allowance for U.S.
    Patent applications 12/074,101 and 11/784,526, respectively. Both
    patent applications are entitled "Implants for the Treatment of
    Dopamine Associated States." These patents, which are now issued, will
    provide protection for NP201, NuPathe's long-term biodegradable
    ropinirole implant for the treatment of Parkinson's disease, into July
    2028 and October 2027, respectively.

  
Second Quarter 2013 Financial Results
 NuPathe reported a net loss
applicable to common stockholders of $4.9 million, or $0.16 per
diluted share, for the second quarter of 2013, compared with a net
loss applicable to common shareholders of $6.2 million, or $0.42 per
diluted share, for the second quarter of 2012. Total operating
expenses for the second quarter of 2013 were $4.7 million, compared
with $5.8 million in the second quarter of 2012. 
Research and development expenses were $2.4 million in the second
quarter of 2013, compared with $3.4 million in the second quarter of
2012. The decrease was largely attributable to higher expenses in the
2012 period for clinical and manufacturing related activities as the
Company prepared for the NDA resubmission for ZECUITY as well as
reduced compensation expenses in the 2013 period due to fewer
headcount. This was partially offset by slightly increased expenses
in the 2013 period in the areas of regulatory, quality assurance and
medical affairs in preparation of the expected fourth quarter launch
of ZECUITY. Selling, general and administrative expenses were $2.3
million in the second quarter of 2013, in-line with $2.4 million for
the same period in 2012. 
Net cash used in operating activities for the six months ended June
30, 2013 was $6.8 million, primarily the result of spending for
normal operating activities and manufacturing scale up and
commercialization activities expended in preparation of the expected
fourth quarter launch of ZECUITY. During this period NuPathe also
used $2.2 million of cash in investing activities, primarily for the
purchase of commercial manufacturing equipment for ZECUITY, and
received $2.5 million of cash from financing activities, primarily
from the exercise of outstanding common stock warrants. 
As of June 30, 2013, NuPathe had 31.3 million common shares
outstanding. 
As of June 30, 2013, NuPathe had $16.1 million in cash and cash
equivalents and working capital of $10.7 million, compared with $22.6
million in cash and cash equivalents and working capital of $19.8
million as of December 31, 2012. Management estimates that the
Company's existing cash and cash equivalents will be sufficient to
fund operations and debt service obligations into the fourth quarter
of 2013. The additional capital that the Company will require to
launch ZECUITY and to fund operations and debt service obligations
beyond that point will depend largely upon the timing, scope, terms
and structure of a commercial partnership for ZECUITY. To meet its
capital needs, the Company intends to raise additional capital
through a range of possible transactions including corporate
collaborations, partnerships or other strategic transactions; debt or
equity financings or other funding opportunities. However, there is
no assurance that the Company will be able to secure a commercial
partner on acceptable terms, and additionally no assurance that
additional required capital will be available when needed or on
acceptable terms. 
Company to Host Conference Call
 NuPathe will host a conference call
today, August 8, 2013, at 8:30 a.m. EDT to discuss the Company's
financial results for the quarter ended June 30, 2013, and recent
operational highlights. A question and answer session will follow
NuPathe's remarks. To participate on the live call, please dial
888-539-3678 (domestic) or +1-719-457-2085 (international), and
provide the participant passcode 9329622, 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 9329622. 
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. 
About ZECUITY(R) 
 ZECUITY (sumatriptan iontophoretic transdermal
system) is indicated for the acute treatment of migraine with or
without aura in adults. ZECUITY is a single-use, battery-powered
patch applied to the upper arm or thigh during a migraine. Following
application and with a press of a button, ZECUITY initiates
transdermal delivery (through the skin), bypassing the
gastrointestinal tract. Throughout the four-hour dosing period, the
microprocessor within ZECUITY continuously monitors skin resistance
and adjusts drug delivery accordingly to ensure delivery of 6.5 mg of
sumatriptan, the most prescribed migraine medication in the U.S.,
with minimal patient-to-patient variability.  
Important Safety Information 
 Patients should not take ZECUITY if
they have heart disease, a history of heart disease or stroke,
peripheral vascular disease (narrowing of blood vessels to your legs,
arms, stomach or kidney), transient ischemic attack (TIA) or problems
with blood circulation, uncontrolled blood pressure, migraines that
cause temporary paralysis on one side of the body or basilar
migraine, Wolff-Parkinson-White syndrome or other disturbances of
heart rhythm. Very rarely, certain people, even some without heart
disease, have had serious heart-related problems after taking
triptans like ZECUITY.  
Patients should not use ZECUITY if they have taken other migraine
medications such as ergotamine medications or other triptans in the
last 24 hours or if they have taken monoamine oxidase-A (MAO-A)
inhibitors within the last 2 weeks. 
Patients should not use ZECUITY during magnetic resonance imaging
(MRI). 
Patients should not use ZECUITY if they have an allergy to
sumatriptan or components of ZECUITY or if they have had allergic
contact dermatitis (ACD) following use of ZECUITY. If patients
develop ACD, they should talk to their healthcare provider before
using sumatriptan in another form. 
ZECUITY, like other triptans, may be associated with a potentially
life-threatening condition called serotonin syndrome, mainly when
used together with certain types of antidepressants including
serotonin reuptake inhibitors (SSRIs) or serotonin norepinephrine
reuptake inhibitors (SNRIs).  
Patients should tell their healthcare provider before using ZECUITY
if they have heart disease or a family history of heart disease,
stroke, high cholesterol or diabetes; have gone through menopause;
are a smoker; have had epilepsy or seizures or if they are pregnant,
nursing or thinking about becoming pregnant.  
The most common side effects of ZECUITY are application site pain,
tingling, itching, warmth and discomfort. Most patients experience
some skin redness after removing ZECUITY. This redness typically goes
away in 24 hours.  
Please see full Prescribing Information for ZECUITY. 
Patients are encouraged to report negative side effects of
prescription drugs to the FDA. Visit www.FDA.gov/medwatch or call
1-800-FDA-1088. 
Patients and healthcare providers interested in more information on
ZECUITY should visit www.zecuity.com. 
About Migraine and Migraine-Related Nausea (MRN)
 Migraine is a
debilitating neurological disease afflicting a large underserved
patient population. Migraine is characterized by headache pain
accompanied by associated neurological and GI symptoms including
nausea, vomiting, photophobia, and phonophobia.(1,2) In the U.S., 31
million adults, with approximately three times as many women as
men,(3) suffer from migraine.(3,4,5) Of the 16 million migraine
patients who are diagnosed and treated, approximately eight million
experience migraine-related nausea (MRN) in at least half of their
migraine attacks.(6) These frequent-MRN patients report significantly
more migraine symptom burden and experience significantly more
interference with work, social and family life.(6) Many migraine
patients who experience MRN delay or avoid taking orally administered
medications due to nausea or vomiting.(7) 
About NuPathe
 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, ZECUITY (sumatriptan iontophoretic
transdermal system), has been approved by the FDA for the acute
treatment of migraine with or without aura in adults. ZECUITY is
expected will to be available by prescription in the fourth quarter
of 2013. In addition to ZECUITY, NuPathe has two proprietary product
candidates based on its LAD(TM), 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 designed to provide up to two months of continuous
delivery. NP202, for the long-term treatment of schizophrenia and
bipolar disorder, is designed 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 ZECUITY and its other product candidates in the U.S. and
territories throughout the world. 
For more information about NuPathe, please visit our website 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: the potential benefits of, and
commercial opportunity for, ZECUITY and NuPathe's other product
candidates; partnering plans for ZECUITY and NuPathe's other product
candidates; the timing of the expected launch and availability of
ZECUITY; the scope and duration of protection to be afforded by the
referenced patents; the sufficiency of the Company's cash and cash
equivalents to fund operations and debt service obligations into the
fourth quarter of 2013; and other statements relating to NuPathe's
plans, objectives, expectations and beliefs regarding its future
operations, performance, financial condition and other future events.
Forward-looking statements are based upon management's current
expectations 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 from those indicated herein
including, among others: NuPathe's ability to obtain sufficient
capital to launch ZECUITY and continue as a going concern; NuPathe's
ability to obtain commercial partners for ZECUITY and its other
product candidates; risks and uncertainties relating to intellectual
property; NuPathe's reliance on third parties to manufacture ZECUITY;
NuPathe's ability to establish and effectively manage its supply
chain; NuPathe's ability to establish effective marketing and sales
capabilities; market acceptance among physicians and patients and the
availability of adequate reimbursement from third party payors for
ZECUITY; and the risks, uncertainties and other factors discussed in
NuPathe's Annual Report on Form 10-K for the year ended December 31,
2012 under the caption "Risk Factors" and else
where in such report,
which is available on NuPathe's website at www.nupathe.com in the
"Investor Relations -- SEC Filings" section. While NuPathe may update
certain forward-looking statements from time to time, it 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. 
References 
1. ICHD-II. Cephalagia 2004; 24 (Suppl 1). 
 2. Lipton, R. et al.
Classification of primary headaches. Neurology. 2004:63:427-435. 
 3.
Lipton, R. et al. Prevalence and Burden of Migraine in the United
States: Data From the American Migraine Study II. Headache,
July/August 2001: p. 646. 
 4. US Census Data. 1999, accessed at
http://www.census.gov/prod/2001pubs/p23-205.pdf 01/03/13; and 2010,
accessed at http://www.census.gov/2010census/data/. 
 5. NuPathe
Analysis. 
 6. Lipton, R. et al. "Frequency and Burden of
Headache-Related Nausea: Results from the American Migraine
Prevalence and Prevention (AMPP) Study." Headache 2012:53:93-103.
Funded by a research grant from NuPathe Inc. 
 7. Silberstein, S.
Migraine symptoms: results of a survey of self-reported migraineurs.
Headache 1995;35:387-396.  


 
                                                                            
                                NUPATHE INC.                                
                       (A Development-Stage Company)                        
                          Statements of Operations                          
             (In thousands, except share and per share amounts)             
                                (Unaudited)                                 
                                                                            
                                                                            
                                                                            
                                                                            
                    Three Months Ended June 30,   Six Months Ended June 30, 
                    ---------------------------  -------------------------- 
                        2013           2012          2013          2012     
                    ------------   ------------  ------------  ------------ 
Operating expenses:                                                         
  Research and                                                              
   development      $      2,354   $      3,359  $      4,344  $      6,813 
  Selling, general                                                          
   and                                                                      
   administrative          2,323          2,420         5,307         4,807 
                    ------------   ------------  ------------  ------------ 
                           4,677          5,779         9,651        11,620 
                    ------------   ------------  ------------  ------------ 
       Loss from                                                            
        operations        (4,677)        (5,779)       (9,651)      (11,620)
Interest income                3              6             8            16 
Interest expense            (236)          (395)         (487)         (848)
Change in fair                                                              
 value of warrants             -              -       (12,162)            - 
                    ------------   ------------  ------------  ------------ 
       Net loss           (4,910)        (6,168)      (22,292)      (12,452)
                                                                            
Series A Preferred                                                          
 Stock dividends               -              -          (314)            - 
                    ------------   ------------  ------------  ------------ 
Net loss applicable                                                         
 to common                                                                  
 stockholders       $     (4,910)  $     (6,168) $    (22,606) $    (12,452)
                    ============   ============  ============  ============ 
Basic and diluted                                                           
 net loss per                                                               
 common share       $      (0.16)  $      (0.42)        (0.80) $      (0.85)
                    ============   ============  ============  ============ 
                                                                            
Weighted average                                                            
 basic and diluted                                                          
 common shares                                                              
 outstanding          30,668,060     14,736,809    28,289,184    14,734,696 
                    ============   ============  ============  ============ 
                                                                            
                                                                            
                                                                            
                                NUPATHE INC.                        
                       (A Development-Stage Company)                
                             Balance Sheet Data                     
                               (In thousands)                       
                                (Unaudited)                         
                                                                    
                                                       December 31, 
                                       June 30, 2013       2012     
                                      --------------  --------------
                                                                    
       Cash and cash equivalents      $       16,056  $       22,570
       Working capital (deficit)              10,704          19,847
       Total assets                           25,978          30,607
       Long-term debt                          6,587           8,102
       Total stockholders' equity             13,781           3,013

  
Contact Information:  
INVESTOR CONTACTS:
Westwicke Partners
John Woolford
(443) 213-0506
john.woolford@westwicke.com 
Keith A. Goldan
Senior Vice President, Chief Financial Officer
NuPathe Inc.
(484) 567-0130 
MEDIA CONTACTS:
Sam Brown Inc.
Mariesa Kemble
(608) 850-4745
mariesak@sambrown.com 
 
 
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