NuPathe Announces Third Quarter 2013 Financial Results and Recent Operational Highlights

NuPathe Announces Third Quarter 2013 Financial Results and Recent Operational 
Highlights 
MALVERN, PA -- (Marketwired) -- 11/14/13 --  NuPathe Inc. (NASDAQ:
PATH) today announced financial results for the quarter ended
September 30, 2013, as well as recent operational highlights. 
"We have made substantial progress in securing a partner to maximize
the commercial potential of Zecuity," said Armando Anido, chief
executive officer of NuPathe. "In addition, we remain on track to
have Zecuity launch supplies manufactured by year-end. We believe
this puts us in a good position to secure a commercial partner. While
we have made significant progress on the partnership and
manufacturing fronts, in order to extend our cash runway, we are
limiting and delaying certain sales and marketing activities. As a
result, we will not commercialize Zecuity by year-end, but we intend
to launch as expeditiously as possible after securing a partner and
funding." 
Quarterly and Recent Highlights 


 
--  The Company progressed commercial manufacturing activities for
    Zecuity(R), including entering into a commercial supply and license
    agreement with LTS Lohmann Therapy Systems Corp. for the drug product
    in Zecuity, as well as significant progression of key process
    validation steps.
--  In September, NuPathe initiated dosing of patients for a Phase 1 study
    of Zecuity in adolescents with a history of migraine attacks. This
    open label, single-dose study will assess the safety,
    pharmacokinetics, and tolerability of Zecuity in adolescent migraine
    patients. This study is part of the Company's post-marketing
    requirements.
--  In September, the United States Patent and Trademark Office (USPTO)
    issued a notice of allowance for U.S. Patent application 13/407,434.
    This application relates to Zecuity's two-stage iontophoretic delivery
    sequence to transdermally deliver sumatriptan. Once issued, this
    patent will provide additional protection for Zecuity and will be the
    sixth patent covering Zecuity to be listed in the U.S. Food & Drug
    Administration's (FDA) Orange Book.
--  In September, NuPathe relocated its principal offices to 7 Great
    Valley Parkway, Suite 300, Malvern, Pennsylvania.

  
Zecuity Launch Update
 NuPathe is acti
vely seeking partnerships to
maximize the commercial potential of Zecuity. The Company's goal is
to secure a commercial partner prior to the launch of Zecuity and to
build its commercial infrastructure to complement that of a partner,
which may include the hiring and deployment of its own specialty
sales force. Until such time as the Company is able to secure a
commercial partner and/or additional capital, the Company is limiting
and delaying certain expenditures required for the commercialization
of Zecuity. As a result, NuPathe will not launch Zecuity in the
fourth quarter of 2013. The timing of the launch of Zecuity will be
dependent upon the completion of a commercial partnership for Zecuity
and/or obtaining the additional capital required for launch. Although
the Company is limiting certain commercialization expenditures,
expenditures required to validate the manufacturing process for
Zecuity continue and Zecuity launch supplies are expected to be
manufactured by the end of 2013. NuPathe believes that the
availability of launch supplies is important to the completion of a
commercial partnership and/or funding transaction and to an
expeditious launch thereafter. However, there is no assurance that
the Company will be able to secure a commercial partner or the
additional required capital on acceptable terms or otherwise. 
Third Quarter 2013 Financial Results
 NuPathe reported a net loss
applicable 
to common stockholders of $7.8 million, or $0.25 per
diluted share, for the third quarter of 2013, compared with a net
loss applicable to common stockholders of $6.2 million, or $0.42 per
diluted share, for the third quarter of 2012. Total operating
expenses for the third quarter of 2013 were $7.6 million, compared
with $5.7 million in the third quarter of 2012. 
Research and development expenses were $3.9 million in the third
quarter of 2013, compared with $2.2 million in the third quarter of
2012. The increase was largely attributable to higher expenses
related to manufacturing scale-up. This was partially offset by
reduced compensation expenses in the 2013 period due to a lower
headcount. Selling, general and administrative expenses were $3.7
million in the third quarter of 2013, in-line with $3.5 million for
the same period in 2012. 
Net cash used in operating activities for the nine months ended
September 30, 2013, was $12.0 million, primarily the result of
spending for normal operating activities, manufacturing scale-up and
commercialization activities conducted in preparation of the launch
of Zecuity. During this period NuPathe also used $2.7 million of cash
in investing activities, primarily for the purchase of commercial
manufacturing equipment for Zecuity, and received $2.4 million of
cash from financing activities, primarily from the exercise of
outstanding common stock warrants. 
As of September 30, 2013, NuPathe had $10.3 million in cash and cash
equivalents and working capital of $2.9 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 through January of 2014.
The additional capital that the Company will require to fund
operations and debt service obligations beyond that point and launch
Zecuity will depend largely upon the timing, scope, terms and
structure of a commercial partnership for Zecuity. To address its
capital needs, the Company is considering a range of possible
transactions including corporate collaborations, partnerships and
other strategic transactions; debt and equity financings and other
funding transactions. However, there is no assurance that the Company
will be able to complete any such transaction or obtain the
additional required capital on acceptable terms or otherwise. If the
Company is unable to obtain the necessary capital, it will need to
pursue a plan to license or sell its assets and/or seek bankruptcy
protection. Additionally, failure to obtain the necessary capital in
a timely manner could result in the Company's breach or default under
important agreements resulting in, among other things, the potential:
acceleration of payments under the Company's 2012 term loan and the
ability of the lender to proceed against the collateral securing the
loan, including the exercise of control over the Company's cash and
investment accounts pursuant to the account control agreements;
acceleration of payments under the Company's office lease; and
termination of agreements on which the Company relies for the
manufacture of Zecuity or pursuant to which the Company obtains
valuable rights.  
Company to Host Conference Call
 NuPathe will host a conference call
today, November 14, 2013, at 4:30 p.m. EST to discuss the Company's
financial results for the quarter ended September 30, 2013, and
recent operational highlights. A question and answer session will
follow NuPathe's remarks. To participate on the live call, please
dial 877-591-4951 (domestic) or +1-719-325-4903 (international), and
provide the participant passcode 7609790, approximately five to ten
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 7609760. 
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. 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 and the prospects of obtaining a commercial partner for
Zecuity; the expected manufacture of Zecuity launch supplies by the
end of 2013; the company's commercial plans and the timing of the
expected launch of Zecuity; the scope and duration of protection to
be afforded by the referenced patents and patent applications; the
sufficiency of the Company's cash and cash equivalents to fund
operations and debt service obligations through January of 2014; the
transactions being considered by the company to address its capital
needs; the potential consequences of failing to obtain additional
capital in a timely manner including, without limitation: defaulting
under the Company's 2012 term loan resulting in the acceleration of
payments and the ability of the lender to proceed against the
collateral securing the loan including the exercise of control over
the Company's cash and investment accounts; defaulting under the
Company's office resulting in the acceleration of payments
thereunder; the breach or termination of agreements on which the
Company relies for the manufacture of Zecuity or pursuant to which
the Company obtains valuable rights; and need to pursue a plan to
license or sell the Company's assets and/or seek bankruptcy
protection; 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 continue as a going concern and launch Zecuity; NuPathe's
ability to obtain a commercial partner for Zecuity; risks and
uncertainties relating to intellectual property; the company's
ability to complete the validation of the manufacturing process for
Zecuity and manufacture commercial supplies; 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 elsewhere 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         Nine Months Ended    
                                  Sept 30,                  Sept 30,        
                          -----------------------   ----------------------- 
                             2013         2012         2013         2012    
                          ----------  -----------   ----------  ----------- 
Operating expenses:                                                         
  Research and                                                              
   development           $     3,932  $     2,220  $     8,275  $     9,033 
  Selling, general and                                                      
   administrative              3,655        3,525        8,963        8,332 
                          ----------   ----------   ----------   ---------- 
                               7,587        5,745       17,238       17,365 
                          ----------   ----------   ----------   ---------- 
    Loss from operations      (7,587)      (5,745)     (17,238)     (17,365)
Interest income                    2            2           10           17 
Interest expense                (226)        (446)        (713)      (1,293)
Change in fair value of                                                     
 warrants                          -            -      (12,162)           - 
                          ----------   ----------   ----------   ---------- 
    Net loss                  (7,811)      (6,189)     (30,103)     (18,641)
                                                                            
Series A Preferred Stock                                                    
 dividends                         -            -         (314)           - 
                          ----------   ----------   ----------   ---------- 
Net loss applicable to                                                      
 common stockholders     $    (7,811) $    (6,189) $   (30,417) $   (18,641)
                          ==========   ==========   ==========   ========== 
Basic and diluted net                                                       
 loss per common share   $     (0.25) $     (0.42)       (1.04) $     (1.26)
                          ==========   ==========   ==========   ========== 
                                                                            
Weighted average basic                                                      
 and diluted common                                                         
 shares outstanding       31,468,063   14,752,214   29,360,455   14,740,578 
                          ==========   ==========   ==========   ========== 
                                                                            
                                                                            
                                                                            
                                                                            
                                NUPATHE INC.                                
                        (A Development-Stage Company)                       
                             Balance Sheet Data                             
                               (In thousands)                               
                                 (Unaudited)                                
                                                                            
                                             September 30,     December 31, 
                                                  2013             2012     
                                            --------------- ----------------
                                                                            
Cash and cash equivalents                  $         10,324 $         22,570
Working capital                                       2,870           19,847
Total assets                                         21,421           30,607
Long-term debt                                        5,802            8,102
Total stockholders' equity                            7,208            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.
(610) 232-0800 
MEDIA CONTACTS:
Sam Brown Inc.
Mariesa Kemble
(608) 850-4745
mariesak@sambrown.com 
 
 
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