##### Table of Contents



UNITED STATES
SECURITIES AND EXCHANGE COMMISSION
 Washington, D.C. 20549
 
 FORM 10-K
 
 (Mark One)
 þ
    
    ANNUAL REPORT PURSUANT TO SECTION 13 OR 15(D) OF THE SECURITIES EXCHANGE ACT OF 1934
 For the fiscal year ended December 31, 2010
 OR
 o
    
    TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(D) OF THE SECURITIES EXCHANGE ACT OF 1934
 Commission file number 001-34836
 
 NuPathe Inc.
 (Exact name of registrant as specified in its charter)
 
 Delaware
(State or other jurisdiction of 
incorporation or organization)
    
    20-2218246
(IRS Employer
Identification number)227 Washington Street 
Suite 200
Conshohocken, Pennsylvania
(Address of principal executive offices)
    
    19428
(Zip Code)
 Registrants telephone number, including area code: (484) 567-0130
 
 Securities registered pursuant to Section 12(b) of the Securities Exchange Act of 1934:
 Title of each class
    
    Name of each exchange on which registeredCommon Stock, $0.001 par value per share
    
    The NASDAQ Stock Market LLC
(The NASDAQ Global Market)
 Securities registered pursuant to Section 12(g) of the Securities Exchange Act of 1934:
 None
 
 Yes o No þ
 o þ
 þ o
 o o
 þ
  Large accelerated filer o
    
    Accelerated filer o
    
    Non-accelerated filer þ
    
    Smaller reporting company o
 o þ
   DOCUMENTS INCORPORATED BY REFERENCE




---



##### 



NUPATHE INC.
 Annual Report on Form 10-K for the Fiscal Year Ended December 31, 2010
 Table of Contents
 CAUTIONARY NOTE REGARDING FORWARD-LOOKING STATEMENTS
    
    
    iPART IItem 1. Business
    
    
    1Item 1A. Risk Factors
    
    
    24Item 1B. Unresolved Staff Comments
    
    
    47Item 2. Properties
    
    
    47Item 3. Legal Proceedings
    
    
    47Item 4. (Removed and Reserved)
    
    
    47PART IIItem 5. Market for Registrants Common Equity, Related Stockholder Matters
and Issuer Purchases of Equity Securities
    
    
    48Item 6. Selected Financial Data
    
    
    50Item 7. Managements Discussion and Analysis of Financial Condition and
Results of Operations
    
    
    51Item 7A. Quantitative and Qualitative Disclosures About Market Risk
    
    
    60Item 8. Financial Statements and Supplementary Data
    
    
    61Item 9. Changes in and Disagreements With Accountants on Accounting and
Financial Disclosure
    
    
    82Item 9A Controls and Procedures
    
    
    82Item 9B Other Information
    
    
    82PART IIIItem 10. Directors, Executive Officers and Corporate Governance
    
    
    83Item 11. Executive Compensation
    
    
    83Item 12. Security Ownership of Certain Beneficial Owners and Management and
Related Stockholder Matters
    
    
    83Item 13. Certain Relationships and Related Transactions, and Director Independence
    
    
    83Item 14. Principal Accountant Fees and Services
    
    
    83PART IVItem 15. Exhibits, Financial Statement Schedules
    
    
    84SIGNATURESEXHIBIT INDEXExhibit 10.12Exhibit 10.26Exhibit 10.28Exhibit 10.29Exhibit 23.1Exhibit 31.1Exhibit 31.2Exhibit 32.1




---



##### Table of Contents



CAUTIONARY NOTE REGARDING FORWARD-LOOKING STATEMENTS
  
    
    our plans to develop and commercialize Zelrix and our other product candidates;
 
    
    the timing of, and our ability to obtain, marketing approval of Zelrix and our other
product candidates;
 
    
    the timing of our anticipated commercial launch of Zelrix and our other product
candidates;
 
    
    our ongoing and planned preclinical studies and clinical trials;
 
    
    the rate and degree of market acceptance of Zelrix and any other future products;
 
    
    the size and growth of the potential markets for Zelrix and our other product candidates
and our ability to serve those markets;
 
    
    our commercialization and marketing capabilities;
 
    
    our ability to obtain and maintain intellectual property protection and the scope of such
protection;
 
    
    legal and regulatory developments in the U.S. and foreign countries;
 
    
    the performance of third party manufacturers;
 
    
    our ability to establish and effectively manage a supply chain;
 
    
    our ability to acquire or license suitable product candidates or technologies from third
parties;
 
    
    future expenses and capital requirements;
 
    
    the sufficiency of our cash and cash equivalents to fund our operations and capital
requirements through FDA approval and into the expected commercial launch of Zelrix in the
first half of 2012; and
 
    
    our ability to raise additional capital in sufficient amounts or on terms acceptable to
us;
     i




---



##### Table of Contents



PART I
 
 ITEM 1.
    
    BUSINESS
 Overview
       
    
    Circumvent nausea and vomiting.Because Zelrix is administered transdermally, we believe
that nausea and vomiting relating to a migraine will not impede its use.
 
    
    Increase consistency of response.Because Zelrix does not depend on gastrointestinal
absorption, its absorption will not be compromised by the reduced gastric motility
experienced by some migraineurs. As a result, we believe that Zelrix will provide more
consistent relief than oral medications.
 
    
    Minimize triptan adverse events.Because Zelrix tightly controls the delivery of
sumatriptan, we believe its use will result in a low incidence of triptan adverse events
while effectively treating migraine  as demonstrated in our clinical trials.
   1




---



##### Table of Contents



Our Product Candidates
  ProductCandidate
    
    Indication(s)
    
    Description
    
    Development StatusZelrix
    
    Acute migraine
    
    Active, single-use
sumatriptan transdermal
patch
    
    
    
    NDA submitted in October 2010.
PDUFA date is August 29, 2011.
    
    One ongoing long-term, open label
Phase III trial.NP201
    
    Parkinsons disease
    
    Ropinirole two-month implant
    
    
    
    Expected Investigational New Drug
submission during first half of
2011.
    
    Preclinical proof of concept
completed.NP202
    
    Schizophrenia and
bipolar disorder
    
    Atypical antipsychotic
three-month implant
    
    
    
    Expected Investigational New Drug
submission in 2012.
    
    Prototype development in progress.
 Migraine Market
 Overview
 Neurology
 Headache Headache
  Migraine-Associated Nausea and Vomiting
 Headache
  2




---



##### Table of Contents



Migraine-Associated Gastroparesis
 Headache
 Treatment of Acute Migraine
  
    
    Triptans, including a triptan combination;
 
    
    Ergotamines (including dihydroergotamine, or DHE);
 
    
    Analgesic combinations; and
 
    
    A non-steroidal anti-inflammatory drug, or NSAID, which commercially launched in June
2010.
   2010 UnitsRoute of
    
    Sold(1)
    
    
    2010 SalesProduct Class
    
    Key Product Brands (Drug)
    
    Administration
    
    (% Total)
    
    
    (% Total)Triptan
    
    
    
    Generic sumatriptan and Imitrex
Maxalt (rizatriptan)
    
    Tablet, orally disintegrating tablet, nasal spray, injection
    
    123.1 million (74.5%)
    
    $1.63 billion (96.6%)
    
    Zomig (zolmitriptan)
    
    Relpax (eletriptan)
    
    Treximet (sumatriptan/naproxen)
    
    Sumavel DosePro (subcutaneous sumatriptan)Analgesic Combination
    
    
    
    Epidrin, Midrin, Migrazone and generics (isometheptene mucate, dichloralphenazone, acetaminophen)
    
    Capsule
    
    37.3 million (22.6%)
    
    $17.5 million (1.0%)
    
    Prodrin (acetaminophen, caffeine, isometheptene)Ergotamine
    
    

    
    Migranal (dihydroergotamine)
DHE-45 and generics (dihydroergotamine)
    
    Nasal spray, injection, tablet suppository
    
    4.8 million (2.9%)
    
    $40.7 million (2.4%)
    
    Cafergot and generics (dihydroergotamine, caffeine)
 
 (1)
    
    A unit represents a single dose of each medication.  3




---



##### Table of Contents



Limitations of Current Treatments for Acute Migraine
  
    
    Administration challenges from nausea and vomiting.Patients with nausea often delay
taking medication until the nausea subsides, may skip treatment altogether or, in extreme
cases, force themselves to vomit. According to a survey conducted by the National Headache
Foundation in 2008, 48% of respondents who ever experienced nausea or vomiting with a
migraine reported that the nausea or vomiting had a moderate to major impact on when or how
they take migraine medications. In the same survey, some migraineurs reported they delay
taking migraine medication until nausea subsides, while others reported they avoid taking
their migraine medication altogether because of nausea or vomiting. This runs contrary to
well-accepted clinical practice, which stresses the importance of treating migraines without
delay.
 
    
    Poor or inconsistent relief.According to a 2001 article by Dr. Michel Ferrari published
in The Lancet, a peer-reviewed medical journal, clinical trials have demonstrated that at
least 40% of migraineurs fail to respond consistently to oral triptans. Based on data from
multiple published third party clinical trials, including those described in a 2005 article
by Dr. David Dodick published in Headache, we believe patients failure to respond
consistently results from a variety of causes, including low and inconsistent absorption of
oral medication because of reduced gastric motility.
 
    
    Fear of adverse events.Many patients avoid or delay treatment because they fear adverse
events, including triptan adverse events. Triptan adverse events include chest tightness,
chest heaviness, numbness of the extremities, paresthesias, or tingling, and panic.
According to U.S. prescribing information, the incidence of triptan adverse events is 47%
for injection and up to 14% for oral sumatriptan. According to a 2003 article by Dr. R.
Michael Gallagher published in Headache, 67% of migraine patients who use prescription
migraine medication reported that they had delayed or avoided taking a prescription migraine
medication due to concerns about adverse events.
 Headache
 Our Solution: Zelrix
  Zelrix Design
   4




---



##### Table of Contents



Potential Benefits of Zelrix
  
    
    Circumventing nausea and vomiting.Because Zelrix is administered transdermally, we
believe that it will be an attractive treatment option for migraineurs suffering from nausea
or vomiting who might otherwise delay or avoid taking medication.
 
    
    Increasing consistency of response.Because Zelrix does not depend on gastrointestinal
absorption, we believe that its absorption will not be compromised by reduced gastric
motility experienced by some migraineurs. As a result, we believe that Zelrix will provide
more consistent relief than oral medications.
 
    
    Minimizing triptan adverse events.By tightly controlling the delivery of sumatriptan,
Zelrix is designed to deliver sumatriptan plasma levels without exceeding levels that were
associated with an increased prevalence of triptan adverse events reported by subjects
treated with oral and injectable sumatriptan in our clinical trials. Because Zelrix tightly
controls the delivery of sumatriptan, we believe that Zelrix use will result in a low
incidence of triptan adverse events while effectively treating migraine  as demonstrated
in our clinical trials.
  Our Zelrix Development Program
   
    
    Eight Phase I clinical trials;
 
    
    One pivotal Phase III clinical trial; and
 
    
    Two long-term, open label Phase III trials, one of which has been completed and the other
is expected to be completed in August 2011; and
 
    
    One skin irritation study.
  Pivotal Phase III Clinical Trial
   5




---



##### Table of Contents




    
    The proportion of patients treated with Zelrix who were nausea free at two hours after
patch application compared to patients treated with placebo;
 
    
    The proportion of patients treated with Zelrix who were photophobia free at two hours
after patch application compared to patients treated with placebo; and
 
    
    The proportion of patients treated with Zelrix who were phonophobia free at two hours
after patch application compared to patients treated with placebo.
  
    
    Adverse event assessments;
 
    
    Investigator skin irritation examination scores; and
 
    
    Subject skin irritation self-examination scores.
  Zelrix
    
    
    PlaceboITT Analysis (1)
    
    Patients
    
    
    PatientsSymptom Two Hours After Patch Application  LOCF (2)
    
    226 Total
    
    
    %
    
    
    228 Total
    
    
    %
    
    
    % Difference
    
    
    p value (3)Headache pain free
    
    
    40
    
    
    
    17.7
    %
    
    
    21
    
    
    
    9.2
    %
    
    
    8.5
    %
    
    
    0.0092Headache pain relief
    
    
    119
    
    
    
    52.9
    
    
    
    65
    
    
    
    28.6
    
    
    
    24.3
    
    
    
    <0.0001Nausea free
    
    
    189
    
    
    
    83.6
    
    
    
    144
    
    
    
    63.2
    
    
    
    20.4
    
    
    
    <0.0001Photophobia free
    
    
    116
    
    
    
    51.3
    
    
    
    83
    
    
    
    36.4
    
    
    
    14.9
    
    
    
    0.0028Phonophobia free
    
    
    125
    
    
    
    55.3
    
    
    
    89
    
    
    
    39.0
    
    
    
    16.3
    
    
    
    0.0002
 
 (1)
    
    Intent-to-Treat (ITT) Analysis: Patients are analyzed in the groups to
which they were randomized, regardless of whether they received or
adhered to the allocated treatment. ITT analysis provides unbiased
comparisons among the treatment groups and is the primary statistical
analysis used by the FDA.(2)
    
    Last Observation Carried Forward: Last observation carried forward is
a method to address missing data. For each individual, missing values
are replaced by the last observed value of that variable.(3)
    
    The results of a clinical trial are statistically significant if they
are unlikely to have occurred by chance. We determined the statistical
significance of the trial results based on a widely used, conventional
statistical method that establishes the pvalue of the results. The
FDA requires a pvalue of 0.05 or less to demonstrate statistical
significance.  6




---



##### Table of Contents




    
    Headache pain relief within one hour.Zelrix demonstrated statistically significant
headache pain relief at one hour after patch application, with 29% of Zelrix patients
experiencing headache pain relief as compared to 19% of placebo patients (p = 0.0123). While
not statistically significant, 38% more Zelrix patients than placebo patients experienced
pain relief in 30 minutes, 29 of 226 Zelrix patients compared to 21 of 228 placebo patients.
 
    
    Sustained pain relief.In a retrospective analysis we conducted, for those patients who
experienced pain relief at two hours, Zelrix demonstrated statistically significant
sustained pain relief at each measurement point from two hours through 24 hours after patch
application, with 34% of Zelrix patients experiencing sustained pain relief as compared to
21% of placebo patients (p = 0.0015). For purposes of this analysis, we defined patients
with sustained relief as patients with no pain or mild pain at all measurement points from
two hours through 24 hours after patch application and who had not taken rescue medication.
 
    
    Freedom from nausea within one hour.Zelrix demonstrated statistically significant
freedom from nausea at one hour after patch application, with 71% of Zelrix patients being
nausea free as compared to 58% of placebo patients (p = 0.0251).
 
    
    Freedom from migraine.Zelrix demonstrated statistically significant freedom from
migraine at two hours after patch application, with 16% of Zelrix patients being migraine
free as compared to 8% of placebo patients (p = 0.0135). Freedom from migraine means the
absence of headache, nausea, photophobia and phonophobia.
 
    
    Decreased use of rescue medication.Zelrix demonstrated a statistically significant
difference in the number of patients that used pain or nausea rescue medication during the
24 hours after patch application, with 40% of Zelrix patients using rescue medication as
compared to 60% of placebo patients (p<0.0001). Rescue medications are any additional
medications taken by the patient to relieve symptoms of migraine after patch application.
   Long-Term, Open Label Phase III Trials
   7




---



##### Table of Contents



Phase I Clinical Trials
    Summary of Triptan Adverse Events
 Number of Subjects Reporting Event (%)NasalAdverse Event
    
    Zelrix
    
    
    Spray
    
    
    Injection
    
    
    OralCategorization
    
    Preferred Term
    
    (17 Subjects)
    
    
    (23 Subjects)
    
    
    (23 Subjects)
    
    
    (23 Subjects)Atypical Sensation
    
    Any adverse events
    
    
    
    
    
    
    
    
    
    
    14 (60.9
    %)
    
    
    2 (8.7
    %)Burning sensation mucosal
    
    
    
    
    
    
    
    
    
    
    3 (13.0
    %)
    
    
    Ear discomfort
    
    
    
    
    
    
    
    
    
    
    1 (4.3
    %)
    
    
    Facial pain
    
    
    
    
    
    
    
    
    
    
    1 (4.3
    %)
    
    
    Feeling hot
    
    
    
    
    
    
    
    
    
    
    2 (8.7
    %)
    
    
    Flushing
    
    
    
    
    
    
    
    
    
    
    6 (26.1
    %)
    
    
    Head discomfort
    
    
    
    
    
    
    
    
    
    
    1 (4.3
    %)
    
    
    1 (4.3
    %)Hot flush
    
    
    
    
    
    
    
    
    
    
    3 (13.0
    %)
    
    
    1 (4.3
    %)Sensation of heaviness
    
    
    
    
    
    
    
    
    
    
    1 (4.3
    %)
    
    
    Sensation of pressure
    
    
    
    
    
    
    
    
    
    
    1 (4.3
    %)
    
    
    Pain and Pressure Sensation
    
    Any adverse events
    
    
    
    
    
    
    
    
    
    
    2 (8.7
    %)
    
    
    4 (17.4
    %)Neck pain
    
    
    
    
    
    
    
    
    
    
    
    
    
    
    2 (8.7
    %)Sensation of heaviness
    
    
    
    
    
    
    
    
    
    
    1 (4.3
    %)
    
    
    1 (4.3
    %)Sensation of pressure
    
    
    
    
    
    
    
    
    
    
    1 (4.3
    %)
    
    
    1 (4.3
    %)
    8




---



##### Table of Contents



Skin Irritation Study
  Commercial Strategy
   Pipeline Products
  NP201: Product candidate for the continuous symptomatic treatment of Parkinsons disease
    Parkinsonism and Related Disorders
  9




---



##### Table of Contents



NP202: Product candidate for the long-term treatment of schizophrenia and bipolar disorder
  The Journal of Clinical Psychiatry
 The New
England Journal of Medicine Psychiatric
Services
   10




---



##### Table of Contents




    
    We are developing NP202 to provide up to three months of continuous delivery of an
atypical antipsychotic with a single dose. Currently available products provide therapy for
only two to four weeks, resulting in frequent physician visits and increasing the risk of
non-compliance;
 
    
    We are designing NP202 to allow a physician to remove the implant at any time during the
dosing period. With currently available injectable products, physicians and patients cannot
stop therapy, which may discourage some physicians and patients concerned about adverse
events; and
 
    
    We are developing NP202 as an easy to administer, pre-loaded injectable product that can
be stored at room temperature. Risperdal Consta, the leading depot injectable product, must
be prepared and mixed prior to administration.
  Our Proprietary Delivery Technologies
  SmartRelief Technology
   Long-Acting Delivery Technology
    11




---



##### Table of Contents



Manufacturing
      Competition
     12




---



##### Table of Contents




    
    Elevating physician awareness of current treatment limitations and impact on patients;
 
    
    Emphasizing differentiating features of Zelrix; and
 
    
    Building on physician experience with sumatriptan, the most prescribed migraine
medication.
  License, Development and Commercial Agreements
  Travanti Pharma Inc.
    13




---



##### Table of Contents



LTS Lohmann Therapie-Systeme AG
       University of Pennsylvania
   14




---



##### Table of Contents



SurModics Pharmaceuticals, Inc.
     15




---



##### Table of Contents



Intellectual Property and Exclusivity
  Patents and Patent Applications
     
    
    Methods and devices for treating migraine using integrated iontophoretic patches,
including Zelrix;
 
    
    Active ingredient reservoir formulations, including the Zelrix formulation; and
 
    
    Electronic control systems and methods for use of the same in delivering an active
pharmaceutical ingredient for an integrated iontophoretic patch, including Zelrix.
  16




---



##### Table of Contents



FDA Marketing Exclusivity
  Trade Secrets and Proprietary Information
  Government Regulation
 Federal Food, Drug and Cosmetic Act
   17




---



##### Table of Contents



New Drug Applications
  
    
    Completion of preclinical laboratory and animal testing in compliance with the FDAs Good
Laboratory Practice, or GLP, regulations;
 
    
    Submission to the FDA of an IND application for human clinical testing, which must become
effective before human clinical trials may begin in the U.S.;
 
    
    Performance of human clinical trials, including adequate and well-controlled clinical
trials, to establish the safety and efficacy of the proposed drug product for each intended
use;
 
    
    Satisfactory completion of an FDA pre-approval inspection of the products manufacturing
facility or facilities to assess compliance with the FDAs cGMP regulations; and
 
    
    Submission to, and approval by, the FDA of an NDA application.
   
    
    Phase I:Sponsors initially conduct clinical trials in a limited population to test the
product candidate for safety, dose tolerance, absorption, metabolism, distribution and
excretion in healthy humans or, on occasion, in patients, such as cancer patients.
 
    
    Phase II:Sponsors conduct clinical trials generally in a limited patient population to
identify possible adverse effects and safety risks, to determine the efficacy of the product
for specific targeted indications and to determine dose tolerance and optimal dosage.
Sponsors may conduct multiple Phase II clinical trials to obtain information prior to
beginning larger and more extensive Phase III clinical trials.
 
    
    Phase III:These include expanded controlled and uncontrolled trials, including pivotal
clinical trials. When Phase II evaluations suggest the effectiveness of a dose range of the
product and acceptability of such products safety profile, sponsors undertake Phase III
clinical trials in larger patient populations to obtain additional information needed to
evaluate the overall benefit and risk balance of the drug and to provide an adequate basis
to develop labeling.
  18




---



##### Table of Contents



19




---



##### Table of Contents



Section 505(b)(2) New Drug Applications
      20




---



##### Table of Contents



International Regulation
       21




---



##### Table of Contents



Third Party Payor Coverage and Reimbursement
     Manufacturing Requirements
   22




---



##### Table of Contents



Other Regulatory Requirements
    Employees
  Available Information
 www.nupathe.com http://www.sec.gov
    23




---



##### Table of Contents



ITEM 1A.
    
    RISK FACTORS
 Our business is subject to substantial risks and uncertainties. Any of the risks and
uncertainties described below, either alone or taken together, could materially and adversely
affect our business, financial condition, results of operations or prospects. In addition, these
risks and uncertainties could cause actual results to differ materially from those expressed or
implied by forward-looking statements contained in this Form 10-K (please read the Cautionary Note
Regarding Forward-Looking Statements appearing at the beginning of this Form 10-K ). The risks and
uncertainties described below are not the only ones we face. Additional risks and uncertainties not
currently known to us or that we currently deem to be immaterial may also materially and adversely
affect our business, financial condition, results of operations or prospects and could cause actual
results to differ materially from those expressed or implied by forward-looking statements.
 Risks Related to Development and Commercialization of Our Product Candidates
 We are heavily dependent on the success of Zelrix. If we fail to obtain marketing approval for and
commercialize Zelrix, or experience delays in doing so, our business will be materially harmed.
   The commercial success of Zelrix and any other product candidates that we develop, if approved in
the future, will depend upon significant market acceptance of these products among physicians,
patients and third party payors.
  
    
    The efficacy, safety and other potential advantages in relation to alternative
treatments;
 
    
    The relative convenience and ease of administration;
    
    The availability of adequate coverage or reimbursement by third parties, such as
insurance companies and other healthcare payors, and by government healthcare programs,
including Medicare and Medicaid;
  24




---



##### Table of Contents




    
    The prevalence and severity of adverse events;
    
    The cost of treatment in relation to alternative treatments, including generic
products;
    
    The extent and strength of marketing and distribution support;
    
    The limitations or warnings contained in a products FDA approved labeling; and
    
    Distribution and use restrictions imposed by the FDA or to which we agree as part of a
mandatory risk evaluation and mitigation strategy or voluntary risk management plan.
  It will be difficult for us to profitably sell any of our product candidates that the FDA approves,
including Zelrix, if reimbursement for such product candidate is limited.
  If we are unable to establish effective marketing and sales capabilities or enter into agreements
with third parties to market and sell our product candidates after they are approved, we may be
unable to generate product revenues.
   25




---



##### Table of Contents



We face significant competition from other pharmaceutical and biotechnology companies. Our
operating results will suffer if we fail to compete effectively.
      26




---



##### Table of Contents



Any failure or delay in preclinical studies or clinical trials for our product candidates may cause
us to incur additional costs or delay or prevent the commercialization of our product candidates
and could severely harm our business.
   
    
    Regulators or institutional review boards may not authorize us to commence a clinical
trial or conduct a clinical trial at a prospective trial site;
 
    
    Our clinical trials may produce negative or inconclusive results, and we may decide, or
regulators may require us, to conduct additional clinical trials or we may abandon projects
that we expect to be promising;
 
    
    The number of subjects required for our clinical trials may be larger than we
anticipate, enrollment in our clinical trials may be slower than we anticipate, or
participants may drop out of our clinical trials at a higher rate than we anticipate;
 
    
    We might have to suspend or terminate our clinical trials if the participants are being
exposed to unacceptable health risks;
  27




---



##### Table of Contents




    
    Regulators or institutional review boards may require that we hold, suspend or
terminate clinical research for various reasons, including noncompliance with regulatory
requirements or our clinical protocols;
 
    
    Regulators may refuse to accept or consider data from clinical trials for various
reasons, including noncompliance with regulatory requirements or our clinical protocols;
    
    The cost of our preclinical or clinical trials may be greater than we anticipate;
 
    
    The supply or quality of our product candidates or other materials necessary to conduct
our clinical trials may be insufficient or inadequate; and
 
    
    The effects of our product candidates may not be the desired effects or the desired
level of effect or may include undesirable side effects or the product candidates may have
other unexpected characteristics.
   
    
    The size and nature of the subject population;
    
    The proximity of subjects to clinical sites;
    
    The eligibility criteria for the trial;
    
    The design of the clinical trial;
    
    Competing clinical trials; and
 
    
    Clinicians and subjects perceptions as to the potential advantages of the medication
being studied in relation to other available therapies, including any new medications that
may be approved for the indications we are investigating.
  Serious adverse events or other safety risks could require us to abandon development and preclude
or limit approval of our product candidates.
    28




---



##### Table of Contents



If we fail to acquire, develop and commercialize product candidates other than Zelrix, our
prospects for future growth and our ability to sustain profitability may be limited.
     
    
    We may be unable to license or acquire the relevant technology on terms that would
allow us to make an appropriate return from such product;
 
    
    Companies that perceive us to be their competitors may be unwilling to assign or
license their product rights to us; or
 
    
    We may be unable to identify suitable products or product candidates within our areas
of expertise.
 Product liability lawsuits could divert our resources, result in substantial liabilities and reduce
the commercial potential of any products that we may successfully develop.
  
    
    Expose us to adverse publicity;
 
    
    Decrease demand for any products that we successfully develop;
 
    
    Cause clinical trial participants to withdraw from clinical trials or be reluctant to
enroll;
    
    Divert our management from pursuing our business strategy;
  29




---



##### Table of Contents




    
    Increase warnings on our product label;
    
    Be costly to defend; and
    
    Force us to limit or forgo further development and commercialization of these products.
  A variety of risks associated with our planned international business relationships could
materially adversely affect our business.
  
    
    Differing regulatory requirements for drug approvals in foreign countries;
    
    Potentially reduced protection for intellectual property rights;
    
    The potential for so-called parallel importing, which is what happens when a local
seller, faced with higher local prices, opts to import goods from a foreign market, with
lower prices, rather than buying them locally;
    
    Unexpected changes in tariffs, trade barriers and regulatory requirements;
    
    Economic weakness, including inflation, or political instability in particular foreign
economies and markets;
    
    Compliance with tax, employment, immigration and labor laws for employees traveling
abroad;
    
    Foreign taxes;
    
    Foreign currency fluctuations, which could result in increased operating expenses and
reduced revenues, and other obligations incident to doing business in another country;
    
    Workforce uncertainty in countries where labor unrest is more common than in the U.S.;
    
    Production shortages resulting from any events affecting raw material supply or
manufacturing capabilities abroad; and
    
    Business interruptions resulting from geo-political actions, including war and
terrorism, or natural disasters, including earthquakes, volcanoes, typhoons, floods,
hurricanes and fires.
   30




---



##### Table of Contents



Risks Related to Our Financial Condition and Capital Requirements
 We have incurred significant operating losses since inception and anticipate that we will incur
continued losses for the foreseeable future. We may never become profitable.
   
    
    Obtaining marketing approval for the marketing of Zelrix and possibly other product
candidates;
 
    
    Commercializing Zelrix and any other product candidates for which we obtain marketing
approval; and
 
    
    Achieving market acceptance of Zelrix and any other product candidates for which we
obtain marketing approval in the medical community and with patients and third party
payors.
  If we fail to obtain additional financing, we may not be able to complete development of and
commercialize Zelrix or any other product candidates.
  
    
    seek marketing approval for Zelrix and complete any additional development activities
that may be required by the FDA;
 
    
    Launch and commercialize Zelrix and any other product candidates for which we obtain
marketing approval; and
 
    
    Continue our development programs to advance our internal product pipeline, which
currently consists of two preclinical product candidates.
    31




---



##### Table of Contents




    
    The outcome of the FDAs review of the NDA for Zelrix;
    
    The cost, scope and timing of activities undertaken to prepare for the potential
commercialization of Zelrix;
    
    The extent to which the FDA may require us to perform additional clinical trials for
Zelrix;
    
    The cost of purchasing manufacturing and other capital equipment for our potential
products;
    
    The scope, progress, results and costs of development for our other product candidates;
    
    The extent to which we acquire or invest in new products, businesses and technologies;
and
    
    The extent to which we choose to establish collaboration, co-promotion, distribution or
other similar agreements for product candidates.
   Our indebtedness may limit cash flow available to invest in the ongoing needs of our business.
  
    
    Requiring us to dedicate a substantial portion of our cash resources to the payment of
interest on, and principal of, our debt, which will reduce the amounts available to fund
working capital, capital expenditures, product development efforts and other general
corporate purposes;
 
    
    Increasing our vulnerability to adverse changes in general economic, industry and
competitive conditions and adverse changes in government regulation;
 
    
    Limiting our flexibility in planning for, or reacting to, changes in our business and
our industry; and
 
    
    Placing us at a competitive disadvantage compared to our competitors that have less
debt.
  32




---



##### Table of Contents



We have a limited operating history, which makes it difficult to evaluate our business and growth
prospects.
   Risks Related to Our Dependence on Third Parties
 We use third parties to manufacture all of our product candidates, including Zelrix, and the
machinery to produce the commercial supply of Zelrix must be designed, built and validated. This
may increase the risk that we will not have sufficient quantities of our product candidates or such
quantities at an acceptable cost, which could result in clinical development and commercialization
of our product candidates being delayed, prevented or impaired.
     33




---



##### Table of Contents




    
    Transfer technology and production capabilities from its German facility where our
clinical supply has been produced to its manufacturing facility in New Jersey;
 
    
    Assemble the commercial scale manufacturing equipment for Zelrix using components
purchased from third party suppliers; and
    
    Test and validate the newly-assembled machinery and production process.
   
    
    Reliance on the third parties for regulatory compliance and quality assurance;
    
    The possible breach of the manufacturing agreements by the third parties because of
factors beyond our control;
 
    
    The possibility of termination or nonrenewal of the agreements by the third parties
because of our breach of the manufacturing agreement or based on their own business
priorities; and
    
    The disruption and costs associated with changing suppliers.
   We may rely on third parties to conduct aspects of our clinical trials. If these third parties do
not successfully carry out their contractual duties or meet expected deadlines, we may be delayed
in obtaining or ultimately not be able to obtain marketing approval for our product candidates.
   34




---



##### Table of Contents



Any collaboration arrangements that we may enter into in the future may not be successful, which
could adversely affect our ability to develop and commercialize our product candidates.
     Risks Related to Regulatory Matters
 If we are unable to obtain marketing approval for Zelrix or our other product candidates, we will
not be able to commercialize our product candidates and our business will be substantially harmed.
   35




---



##### Table of Contents




    
    We may not be able to demonstrate to the satisfaction of the FDA or comparable foreign
regulatory authorities that a product candidate is safe and effective for any indication;
 
    
    The results of clinical trials may not meet the level of statistical or clinical
significance required by the FDA or comparable foreign regulatory authorities for approval;
 
    
    The FDA or comparable foreign regulatory authorities may disagree with the number,
design, conduct or implementation of our clinical trials;
 
    
    We may not be able to demonstrate that a product candidates clinical and other
benefits outweigh its safety risks;
 
    
    We may not be able to demonstrate that a product candidate provides an advantage over
current standard of care or future competitive therapies in development;
 
    
    The FDA or comparable foreign regulatory authorities may disagree with our
interpretation of data from preclinical studies or clinical trials;
 
    
    The FDA or comparable foreign regulatory authorities may not accept data generated at
our clinical trial sites;
 
    
    The data collected from clinical trials of any product candidates that we develop may
not be sufficient to support the submission of an NDA or other submission or to obtain
marketing approval in the U.S. or elsewhere;
 
    
    The FDA may determine that we have identified the wrong reference listed drug or drugs
or that approval of our 505(b)(2) application for Zelrix or any other product candidate is
blocked by patent or non-patent exclusivity of the reference listed drug or drugs; and
 
    
    The FDA or comparable foreign regulatory authorities may identify deficiencies in the
manufacturing or testing processes or facilities of third party manufacturers with which we
enter into agreements for clinical and commercial supplies.
   36




---



##### Table of Contents



Even if we obtain marketing approval for Zelrix or any of our other product candidates, we will
continue to face extensive regulatory requirements and our products may face future development and
regulatory difficulties.
  
    
    Post-market surveillance, post-market studies or post-market clinical trials;
    
    Labeling, packaging, storage, distribution, safety surveillance, advertising,
promotion, recordkeeping and reporting of safety and other post-market information;
 
    
    Monitoring and reporting adverse events and instances of the failure of a product to
meet the specifications in the NDA;
    
    Changes to the approved product, product labeling or manufacturing process;
    
    Advertising and other promotional material; and
    
    Disclosure of clinical trial results on publicly available databases.
  
    
    State wholesale drug distribution laws and the distribution of our product samples to
physicians must comply with the requirements of the Prescription Drug Marketing Act;
 
    
    Sales, marketing and scientific or educational grant programs must comply with the
anti-kickback and fraud and abuse provisions of the Social Security Act, the transparency
provision of the Patient Protection and Affordable Care Act and an associated
reconciliation bill that became law in March 2010, which we refer to collectively as the
Health Care Reform Law, the False Claims Act and similar state laws;
 
    
    Pricing and rebate programs must comply with the Medicaid rebate requirements of the
Omnibus Budget Reconciliation Act of 1990 and the Veterans Health Care Act of 1992; and
 
    
    If products are made available to authorized users of the Federal Supply Schedule of
the General Services Administration, additional laws and requirements apply.
   
    
    Issue warning letters or untitled letters asserting that we are in violation of the
law;
    
    Seek an injunction or impose civil or criminal penalties or monetary fines;
    
    Suspend or withdraw marketing approval;
    
    Suspend any ongoing clinical trials;
    
    Refuse to approve pending applications or supplements to applications submitted by us;
 
    
    Suspend or impose restrictions on operations, including costly new manufacturing
requirements;
 
    
    Seize or detain products, refuse to permit the import or export of products, or require
us to initiate a product recall;
    
    Refuse to allow us to enter into supply contracts, including government contracts;
 
    
    Impose civil monetary penalties; or
 
    
    Pursue civil or criminal prosecutions and fines against our company or responsible
officers.
  37




---



##### Table of Contents



Even if we obtain marketing approval for Zelrix or any of our other product candidates, adverse
effects discovered after approval could limit the commercial profile of any approved product.
  
    
    Regulatory authorities may withdraw their approval of the product;
 
    
    Regulatory authorities may require the addition of labeling statements, such as black
box or other warnings or contraindications;
 
    
    Regulatory authorities may require us to issue specific communications to healthcare
professionals, such as Dear Doctor Letters;
 
    
    Regulatory authorities may impose additional restrictions on marketing and distribution
of the products;
 
    
    Regulatory authorities may issue negative publicity regarding the product, including
safety communications;
 
    
    We may be required to change the way the product is administered, conduct additional
clinical studies or restrict the distribution of the product;
    
    We could be sued and held liable for harm caused to subjects; and
    
    Our reputation may suffer.
  We will need FDA approval of our proposed trade name, Zelrix, and any failure or delay associated
with such approval may delay the commercialization of Zelrix.
  If the FDA does not approve the manufacturing facilities of LTS or any future third party
manufacturers for commercial production, we may not be able to commercialize Zelrix or any of our
other product candidates.
   38




---



##### Table of Contents



Even if our product candidates receive marketing approval in the U.S., we may never receive
marketing approval or commercialize our products outside the U.S.
   Our relationships with customers and payors will be subject to applicable anti-kickback, fraud and
abuse and other healthcare laws and regulations, which could expose us to criminal sanctions, civil
penalties, contractual damages, reputational harm and diminished profits and future earnings.
  
    
    The federal healthcare anti-kickback statute prohibits, among other things, persons
from knowingly and willfully soliciting, offering, receiving or providing remuneration,
directly or indirectly, in cash or in kind, to induce or reward either the referral of an
individual for, or the purchase, order or recommendation of, any good or service, for which
payment may be made under federal healthcare programs such as Medicare and Medicaid;
 
    
    The federal False Claims Act imposes criminal and civil penalties, including civil
whistleblower or qui tam actions, against individuals or entities for knowingly presenting,
or causing to be presented, to the federal government, claims for payment that are false or
fraudulent or making a false statement to avoid, decrease, or conceal an obligation to pay
money to the federal government;
  39




---



##### Table of Contents




    
    The federal Health Insurance Portability and Accountability Act of 1996, as amended by
the Health Information Technology for Economic and Clinical Health Act, imposes criminal
and civil liability for executing a scheme to defraud any healthcare benefit program and
also imposes obligations, including mandatory contractual terms, with respect to
safeguarding the privacy, security and transmission of individually identifiable health
information;
 
    
    The federal false statements statute prohibits knowingly and willfully falsifying,
concealing or covering up a material fact or making any materially false statement in
connection with the delivery of or payment for healthcare benefits, items or services;
 
    
    The federal transparency requirements under the Health Care Reform Law requires
manufacturers of drugs, devices, biologics, and medical supplies to report to the
Department of Health and Human Services information related to physician payments and other
transfers of value and physician ownership and investment interests; and
 
    
    Analogous state laws and regulations, such as state anti-kickback and false claims laws
and transparency laws, may apply to sales or marketing arrangements and claims involving
healthcare items or services reimbursed by non-governmental third party payors, including
private insurers, and some state laws require pharmaceutical companies to comply with the
pharmaceutical industrys voluntary compliance guidelines and the relevant compliance
guidance promulgated by the federal government in addition to requiring drug manufacturers
to report information related to payments to physicians and other healthcare providers or
marketing expenditures and drug pricing.
  Recently enacted and future legislation may increase the difficulty and cost for us to obtain
marketing approval of and commercialize our product candidates and affect the prices we may obtain.
    40




---



##### Table of Contents



Risks Related to Intellectual Property
 We may not be able to rely on our intellectual property to protect our products in the marketplace.
   
    
    Our patents may not be broad or strong enough to prevent competition from identical or
similar products;
    
    We may be required to disclaim part of the term of some patents;
 
    
    There may be prior art of which we are not aware that may affect the validity or
enforceability of a patent claim;
 
    
    There may be prior art of which we are aware, which we do not believe affects the
validity or enforceability of a claim, but which, nonetheless ultimately may be found to
affect the validity or enforceability of a claim;
 
    
    If challenged, a court could determine that our issued patents are not valid or
enforceable;
 
    
    A court could determine that a competitors technology or product does not infringe our
patents; and
 
    
    Our patents and patent applications could irretrievably lapse due to failure to pay
fees or otherwise comply with regulations, or could be subject to compulsory licensing.
  41




---



##### Table of Contents



If we fail to comply with our obligations in our intellectual property licenses with third parties,
we could lose license rights that are important to our business.
     42




---



##### Table of Contents



Our ability to pursue the development and commercialization of Zelrix is significantly dependent
upon obtaining a license of LTSs intellectual property.
  We may infringe the intellectual property rights of others, which may prevent or delay our product
development efforts and stop us from commercializing or increase the costs of commercializing our
products.
   If we are unable to protect the confidentiality of our proprietary information and know-how, the
value of our technology and products could be significantly diminished.
    43




---



##### Table of Contents



Risks Related to Employee Matters and Managing Growth
 If we are not successful in attracting and retaining highly qualified personnel, including our
current senior executive team, we may not be able to successfully implement our business strategy.
   We will need to grow our organization, and we may experience difficulties in managing this growth,
which could disrupt our operations.
  Risks Related to Ownership of Our Common Stock
 The market price of our common stock has been, and may continue to be, highly volatile.
  
    
    Any adverse development or perceived adverse development with respect to the FDAs
review of our NDA for Zelrix, including the FDAs refusal to accept the NDA for substantive
review or a request for additional information;
 
    
    The commercial success of Zelrix, if approved by the FDA;
    
    Results of clinical trials of our product candidates or those of our competitors;
  44




---



##### Table of Contents




    
    Changes or developments in laws or regulations applicable to our product candidates;
    
    Introduction of competitive products or technologies;
    
    Failure to meet or exceed financial projections we provide to the public;
    
    Actual or anticipated variations in quarterly operating results;
    
    Failure to meet or exceed the estimates and projections of the investment community;
    
    The perception of the pharmaceutical industry by the public, legislatures, regulators
and the investment community;
    
    General economic and market conditions and overall fluctuations in U.S. equity markets;
    
    Developments concerning our sources of manufacturing supply;
    
    Disputes or other developments relating to patents or other proprietary rights;
    
    Additions or departures of key scientific or management personnel;
    
    Issuances of debt, equity or convertible securities;
    
    Changes in the market valuations of similar companies; and
    
    The other factors described in this Risk Factors section.
  Our principal stockholders and management own a significant percentage of our stock and will be
able to exert significant control over matters subject to stockholder approval.
  Future sales of shares of our common stock, including shares issued upon the exercise of currently
outstanding options and warrants could negatively affect our stock price.
   45




---



##### Table of Contents



Because we do not intend to pay dividends on our common stock, your returns will be limited to any
increase in the value of our stock.
  Some provisions of our charter documents and Delaware law may have anti-takeover effects that could
discourage an acquisition of us by others, even if an acquisition would be beneficial to our
stockholders, and may prevent attempts by our stockholders to replace or remove our current
management.
  
    
    the ability of our Board of Directors to authorize the issuance of blank check
preferred stock, the terms of which may be established and shares of which may be issued
without stockholder approval;
 
    
    the prohibition of stockholder action by written consent, thereby requiring all
stockholder actions to be taken at a meeting of our stockholders;
    
    the inability of stockholders to call a special meeting of stockholders; and
 
    
    advance notice requirements for nominations for election to the board of directors and
for proposing matters that can be acted upon at stockholder meetings.
  Our business could be negatively affected as a result of the actions of activist stockholders.
  
    
    Responding to proxy contests and other actions by activist stockholders may be costly
and time-consuming, and may disrupt our operations and divert the attention of management
and our employees;
 
    
    Perceived uncertainties as to the potential outcome of any proxy contest may result in
our inability to consummate potential acquisitions, collaborations or licensing
opportunities and may make it more difficult to attract and retain qualified personnel and
business partners; and
 
    
    If individuals that have a specific agenda different from that of our management or
other members of our board of directors are elected to our board as a result of any proxy
contest, such an election may adversely
affect our ability to effectively and timely implement our strategic plan and create
additional value for our stockholders.
  46




---



##### Table of Contents



ITEM 1B. UNRESOLVED STAFF COMMENTS
  
 ITEM 2. PROPERTIES
    
 ITEM 3. LEGAL PROCEEDINGS
  
 ITEM 4. (REMOVED AND RESERVED)
  47




---



##### Table of Contents



PART II
 
 ITEM 5.
    
    MARKET FOR REGISTRANTS COMMON EQUITY, RELATED STOCKHOLDER MATTERS AND ISSUER PURCHASES OF
EQUITY SECURITIES
 Market Information
  Year Ended December 31, 2010:
    
    High
    
    
    LowThird Quarter (beginning August 6, 2010)
    
    $
    9.61
    
    
    $
    7.21Fourth Quarter
    
    $
    9.47
    
    
    $
    5.14
 Comparative Stock Performance Graph
  
 Company/Index
    
    08/06/2010
    
    
    12/31/2010NuPathe Inc.
    
    $
    100.00
    
    
    $
    94.28NASDAQ Composite Index
    
    $
    100.00
    
    
    $
    118.14NASDAQ Biotechnology Index
    
    $
    100.00
    
    
    $
    111.54
   48




---



##### Table of Contents



Holders of Record
  Dividends
  Use of Proceeds from Registered Securities
  
    
    approximately $8.0 million for further clinical development, manufacturing
development, and preparation and submission of an NDA for Zelrix;
 
    
    approximately $0.9 million for the further preclinical development of NP201 and
NP202; and
 
    
    approximately $2.8 million for salaries and related personnel expenses and
approximately $1.4 million for working capital and other general corporate purposes.
    49




---



##### Table of Contents



ITEM 6.
    
    SELECTED FINANCIAL DATA
  Years Ended December 31,Statement of operations data:
    
    2010
    
    
    2009
    
    
    2008
    
    
    2007
    
    
    2006(in thousands, except share and per share data)Revenue
    
    $
    650
    
    
    $
    
    
    
    $
    
    
    
    $
    
    
    
    $
    Operating expenses:Research and development
    
    
    17,064
    
    
    
    11,310
    
    
    
    8,815
    
    
    
    7,761
    
    
    
    3,209Acquired in-process research and development
    
    
    
    
    
    
    
    
    
    
    5,500
    
    
    
    
    
    
    
    Selling, general and administrative
    
    
    4,772
    
    
    
    3,142
    
    
    
    3,075
    
    
    
    1,884
    
    
    
    1,36321,836
    
    
    
    14,452
    
    
    
    17,390
    
    
    
    9,645
    
    
    
    4,572Loss from operations
    
    
    (21,186
    )
    
    
    (14,452
    )
    
    
    (17,390
    )
    
    
    (9,645
    )
    
    
    (4,572
    )Interest income(expense), net
    
    
    (3,670
    )
    
    
    (1,289
    )
    
    
    (121
    )
    
    
    (30
    )
    
    
    (644
    )Loss before tax benefit
    
    
    (24,856
    )
    
    
    (15,741
    )
    
    
    (17,511
    )
    
    
    (9,675
    )
    
    
    (5,216
    )Income tax benefit
    
    
    500
    
    
    
    151
    
    
    
    
    
    
    
    
    
    
    
    Net loss
    
    
    (24,356
    )
    
    
    (15,590
    )
    
    
    (17,511
    )
    
    
    (9,675
    )
    
    
    (5,216
    )Accretion of redeemable convertible preferred stock
    
    
    (2,533
    )
    
    
    (3,617
    )
    
    
    (2,330
    )
    
    
    (1,126
    )
    
    
    (341
    )Net loss applicable to common stockholders
    
    $
    (26,889
    )
    
    $
    (19,207
    )
    
    $
    (19,841
    )
    
    $
    (10,801
    )
    
    $
    (5,557
    )Basic and diluted net loss per common share
    
    $
    (4.39
    )
    
    $
    (50.31
    )
    
    $
    (51.98
    )
    
    $
    (29.38
    )
    
    $
    (16.25
    )Weighted average basic and diluted common shares
outstanding
    
    
    6,126,123
    
    
    
    381,789
    
    
    
    381,681
    
    
    
    367,691
    
    
    
    341,979
 As of December 31,Balance sheet data:
    
    2010
    
    
    2009
    
    
    2008
    
    
    2007
    
    
    2006(in thousands)Cash and cash equivalents
    
    $
    38,918
    
    
    $
    3,927
    
    
    $
    8,368
    
    
    $
    3,830
    
    
    $
    5,211Working capital
    
    
    34,142
    
    
    
    1,527
    
    
    
    6,285
    
    
    
    1,304
    
    
    
    4,437Total assets
    
    
    43,753
    
    
    
    5,009
    
    
    
    9,776
    
    
    
    4,462
    
    
    
    5,400Long-term debt
    
    
    3,704
    
    
    
    
    
    
    
    782
    
    
    
    1,628
    
    
    
    Redeemable convertible preferred
stock
    
    
    
    
    
    
    55,538
    
    
    
    41,809
    
    
    
    16,270
    
    
    
    10,164Total stockholders equity (deficit)
    
    
    34,265
    
    
    
    (54,474
    )
    
    
    (36,141
    )
    
    
    (16,458
    )
    
    
    (5,716
    )
  50




---



##### Table of Contents



ITEM 7.
    
    MANAGEMENTS DISCUSSION AND ANALYSIS OF FINANCIAL CONDITION AND RESULTS OF OPERATIONS
 The following discussion and analysis should be read together with our audited financial
statements and related notes appearing elsewhere in this Form 10-K .
 Overview
    Liquidity and Capital Resources
   
    
    The outcome of the FDAs review of the NDA for Zelrix;
 
    
    The cost, scope and timing of activities undertaken to prepare for the potential
commercialization of Zelrix;
 
    
    The extent to which the FDA may require us to perform additional clinical trials for
Zelrix;
 
    
    The cost of purchasing manufacturing and other capital equipment for our potential
products;
  51




---



##### Table of Contents




    
    The scope, progress, results and costs of development for our other product candidates;
 
    
    The extent to which we acquire or invest in new products, businesses and technologies;
and
 
    
    The extent to which we choose to establish collaboration, co-promotion, distribution or
other similar agreements for product candidates.
   Key Components of Our Statement of Operations
 Research and Development Expenses
  
    
    Expenses associated with regulatory submissions, preclinical development, clinical
trials and manufacturing;
 
    
    Personnel related expenses, such as salaries, benefits, travel and other related
expenses, including stock-based compensation;
 
    
    Payments made to third party investigators who perform research and development on our
behalf;
 
    
    Payments to third party contract research organizations, laboratories and independent
contractors;
 
    
    Expenses incurred to obtain technology licenses if the technology licensed has not
reached technological feasibility and has no alternative future use; and
 
    
    Facility, maintenance and other related expenses
    52




---



##### Table of Contents



Selling, General and Administrative Expenses
   Interest Income and Interest Expense
  Net Operating Losses and Tax Loss Carryforwards
    53




---



##### Table of Contents



Critical Accounting Policies and Use of Estimates
   Research and Development Expenses
  Stock-Based Compensation
    54




---



##### Table of Contents



Impact of Recent Accounting Pronouncements
  Results of Operations
 Comparison of Years Ended December 31, 2010 and 2009
 Revenue
  Research and Development Expenses
  Year Ended
    
    
    IncreaseDecember 31,
    
    
    (Decrease)2010
    
    
    2009
    
    
    $
    
    
    %(In thousands)Clinical development
    
    $
    5,813
    
    
    $
    4,411
    
    
    $
    1,402
    
    
    
    32
    %Manufacturing
    
    
    4,965
    
    
    
    2,490
    
    
    
    2,475
    
    
    
    99Preclinical development
    
    
    
    
    
    
    1,268
    
    
    
    (1,268
    )
    
    
    (100
    )Regulatory and quality assurance
    
    
    2,571
    
    
    
    179
    
    
    
    2,392
    
    
    
    1,336Compensation and related
    
    
    3,019
    
    
    
    2,388
    
    
    
    631
    
    
    
    26Facilities and related
    
    
    696
    
    
    
    574
    
    
    
    122
    
    
    
    21$
    17,064
    
    
    $
    11,310
    
    
    $
    5,754
    
    
    
    51
   55




---



##### Table of Contents



Year Ended
    
    
    IncreaseDecember 31,
    
    
    (Decrease)2010
    
    
    2009
    
    
    $
    
    
    %(In thousands)Zelrix
    
    $
    12,225
    
    
    $
    8,183
    
    
    $
    4,042
    
    
    
    49
    %NP201
    
    
    1,096
    
    
    
    244
    
    
    
    852
    
    
    
    349NP202
    
    
    274
    
    
    
    
    
    
    
    274
    
    
    
    100General development
    
    
    3,469
    
    
    
    2,883
    
    
    
    586
    
    
    
    20$
    17,064
    
    
    $
    11,310
    
    
    $
    5,754
    
    
    
    51
  Selling, General and Administrative Expenses
  Interest Expense
  Income Tax Benefit
   56




---



##### Table of Contents



Comparison of Years Ended December 31, 2009 and 2008
 Research and Development Expenses
  Year Ended
    
    
    IncreaseDecember 31,
    
    
    (Decrease)2009
    
    
    2008
    
    
    $
    
    
    %(In thousands)Clinical development
    
    $
    4,411
    
    
    $
    1,195
    
    
    $
    3,216
    
    
    
    269
    %Manufacturing
    
    
    2,490
    
    
    
    3,051
    
    
    
    (561
    )
    
    
    (18
    )Preclinical development
    
    
    1,268
    
    
    
    1,912
    
    
    
    (644
    )
    
    
    (34
    )Regulatory and quality assurance
    
    
    179
    
    
    
    224
    
    
    
    (45
    )
    
    
    (20
    )Compensation and related
    
    
    2,388
    
    
    
    1,950
    
    
    
    438
    
    
    
    22Facilities and related
    
    
    574
    
    
    
    483
    
    
    
    91
    
    
    
    19$
    11,310
    
    
    $
    8,815
    
    
    $
    2,495
    
    
    
    28
   Year Ended
    
    
    IncreaseDecember 31,
    
    
    (Decrease)2009
    
    
    2008
    
    
    $
    
    
    %(In thousands)Zelrix
    
    $
    8,183
    
    
    $
    5,590
    
    
    $
    2,593
    
    
    
    46
    %NP201
    
    
    244
    
    
    
    743
    
    
    
    (499
    )
    
    
    (67
    )General development
    
    
    2,883
    
    
    
    2,482
    
    
    
    401
    
    
    
    16$
    11,310
    
    
    $
    8,815
    
    
    $
    2,495
    
    
    
    28
  Acquired In-Process Research and Development Expenses
   57




---



##### Table of Contents



Selling, General and Administrative Expenses
  Interest Income/Expense
   Income Tax Benefit
  Cash Flows
   Off-Balance Sheet Arrangements
   58




---



##### Table of Contents



Contractual Obligations
  Payments Due by Period2012 and
    
    
    2014 and
    
    
    2016 andContractual Obligations(1)
    
    Total
    
    
    2011
    
    
    2013
    
    
    2015
    
    
    Thereafter(In thousands)Debt obligations
    
    $
    5,217
    
    
    $
    1,513
    
    
    $
    3,704
    
    
    $
    
    
    
    $
    Interest payments on debt
    
    
    946
    
    
    
    559
    
    
    
    387
    
    
    
    
    
    
    
    License maintenance fees(2)
    
    
    350
    
    
    
    50
    
    
    
    100
    
    
    
    100
    
    
    
    100Operating lease obligations
    
    
    823
    
    
    
    363
    
    
    
    460
    
    
    
    
    
    
    
    Development expenditures(3)
    
    
    1,750
    
    
    
    250
    
    
    
    500
    
    
    
    500
    
    
    
    500Equipment Funding (4)
    
    
    3,595
    
    
    
    3,595
    
    
    
    
    
    
    
    
    
    
    
    $
    12,681
    
    
    $
    6,330
    
    
    $
    5,151
    
    
    $
    600
    
    
    $
    600
 
 (1)
    
    This table does not include any contingent milestone or royalty
payments that may become payable to third parties under license
agreements because the timing and likelihood of such payments are not
known.(2)
    
    Under an agreement with the University of Pennsylvania (Penn), we are
required to pay annual license maintenance fees of up to $50,000 until
the first commercial sale of the first licensed product covered by the
agreement. The agreement currently covers NP201 and NP202. Because we
cannot currently estimate when the first sale of a licensed product
will occur, the table reflects payments only through 2017.(3)
    
    Under the agreement with Penn discussed in footnote 2 to this table,
we are required to expend an aggregate of at least $250,000 annually
toward the development and commercialization of NP201 and NP202, until
the first commercial sale of the first licensed product under the
agreement. Because we cannot currently estimate when the first sale of
a licensed product will occur, the table reflects payments only
through 2017.(4)
    
    Under an agreement with LTS Lohmann Therapie-Systeme AG (LTS), we are
required to pay to LTS an aggregate of 5.4 million in 14 monthly
installments that commenced in June 2010 for the purchase of
manufacturing equipment for Zelrix. As of December 31, 2010, 2.7
million, or approximately $3.6 million based on exchange rates as of
December 31, 2010, remains to be paid.    59




---



##### Table of Contents



ITEM 7A.
    
    QUANTITATIVE AND QUALITATIVE DISCLOSURES ABOUT MARKET RISK
     60




---



##### Table of Contents



ITEM 8.
    
    FINANCIAL STATEMENTS AND SUPPLEMENTARY DATA
 INDEX TO FINANCIAL STATEMENTS
 NUPATHE INC.
(A Development-Stage Company)
 PageReport of Independent Registered Public Accounting Firm
    
    
    62Balance Sheets
    
    
    63Statements of Operations
    
    
    64Statements of Redeemable Convertible Preferred Stock and Stockholders Equity (Deficit)
    
    
    65Statements of Cash Flows
    
    
    67Notes to Financial Statements
    
    
    68
  61




---



##### Table of Contents



Report of Independent Registered Public Accounting Firm
 
     
  62




---



##### Table of Contents



NUPATHE INC.
(A Development-Stage Company)
 
 Balance Sheets
 December 31,2010
    
    
    2009ASSETSCurrent assets:Cash and cash equivalents
    
    $
    38,918,332
    
    
    $
    3,926,574Prepaid expenses and other
    
    
    1,007,774
    
    
    
    918,878Total current assets
    
    
    39,926,106
    
    
    
    4,845,452Property and equipment, net
    
    
    98,266
    
    
    
    70,628Other assets
    
    
    318,218
    
    
    
    93,053Other assets-equipment funding (note 9(c))
    
    
    3,410,315
    
    
    
    Total assets
    
    $
    43,752,905
    
    
    $
    5,009,133LIABILITIES AND STOCKHOLDERS EQUITY (DEFICIT)Current liabilities:Current portion of long-term debt
    
    $
    1,512,867
    
    
    $
    818,139Accounts payable
    
    
    1,198,177
    
    
    
    1,464,106Accrued expenses
    
    
    3,073,017
    
    
    
    1,035,826Total current liabilities
    
    
    5,784,061
    
    
    
    3,318,071Long-term debt
    
    
    3,703,704
    
    
    
    Warrant liability
    
    
    
    
    
    
    626,492Total liabilities
    
    
    9,487,765
    
    
    
    3,944,563Commitments (note 9)Redeemable convertible preferred stock, $0.001 par
value; authorized 10,000,000 and 71,745,055 shares at
December 31, 2010 and December 31, 2009, respectively;
issued and outstanding 53,096,340 shares as of
December 31, 2009
    
    
    
    
    
    
    55,538,191Stockholders equity (deficit):Common stock, $0.001 par value; authorized 90,000,000
shares; issued and outstanding 14,549,461 and 390,676
shares at December 31, 2010 and December 31, 2009,
respectively
    
    
    14,549
    
    
    
    390Additional paid-in capital
    
    
    114,046,923
    
    
    
    Deficit accumulated during the development stage
    
    
    (79,796,332
    )
    
    
    (54,474,011
    )Total stockholders equity (deficit)
    
    
    34,265,140
    
    
    
    (54,473,621
    )Total liabilities and stockholders equity (deficit)
    
    $
    43,752,905
    
    
    $
    5,009,133
   63




---



##### Table of Contents



NUPATHE INC.
(A Development-Stage Company)
 
 Statements of Operations
 Period fromJanuary 7, 2005Year Ended December 31,
    
    
    (inception) through2010
    
    
    2009
    
    
    2008
    
    
    December 31, 2010Grant revenue
    
    $
    649,959
    
    
    $
    
    
    
    $
    
    
    
    $
    649,959Operating expenses:Research and development
    
    
    17,063,840
    
    
    
    11,309,503
    
    
    
    8,815,354
    
    
    
    48,851,409Acquired in-process research and development
    
    
    
    
    
    
    
    
    
    
    5,500,000
    
    
    
    5,500,000Selling, general and administrative
    
    
    4,771,645
    
    
    
    3,142,253
    
    
    
    3,075,084
    
    
    
    14,599,02721,835,485
    
    
    
    14,451,756
    
    
    
    17,390,438
    
    
    
    68,950,436Loss from operations
    
    
    (21,185,526
    )
    
    
    (14,451,756
    )
    
    
    (17,390,438
    )
    
    
    (68,300,477
    )Interest income
    
    
    47,037
    
    
    
    30,437
    
    
    
    157,622
    
    
    
    573,510Interest expense
    
    
    (3,717,686
    )
    
    
    (1,320,005
    )
    
    
    (278,387
    )
    
    
    (6,340,223
    )Loss before tax benefit
    
    
    (24,856,175
    )
    
    
    (15,741,324
    )
    
    
    (17,511,203
    )
    
    
    (74,067,190
    )Income tax benefit
    
    
    500,388
    
    
    
    151,012
    
    
    
    
    
    
    
    651,400Net loss
    
    
    (24,355,787
    )
    
    
    (15,590,312
    )
    
    
    (17,511,203
    )
    
    $
    (73,415,790
    )Accretion of redeemable convertible preferred stock
    
    
    (2,533,495
    )
    
    
    (3,617,211
    )
    
    
    (2,330,344
    )Net loss available to common stockholders
    
    $
    (26,889,282
    )
    
    $
    (19,207,523
    )
    
    $
    (19,841,547
    )Basic and diluted net loss per common share
    
    $
    (4.39
    )
    
    $
    (50.31
    )
    
    $
    (51.98
    )Weighted average basic and diluted common shares
outstanding
    
    
    6,126,123
    
    
    
    381,789
    
    
    
    381,681
   64




---



##### Table of Contents



NUPATHE INC.
(A Development-Stage Company)
 
 Statements of Redeemable Convertible Preferred Stock and Stockholders Equity (Deficit)

Period from January 7, 2005 (inception) through December 31, 2010
 Stockholders Equity (Deficit)DeficitAccumulatedRedeemable Convertible
    
    
    
    
    
    
    
    
    
    
    Additional
    
    
    During thePreferred Stock
    
    
    Common Stock
    
    
    Paid-in
    
    
    DevelopmentShares
    
    
    Amount
    
    
    Shares
    
    
    Amount
    
    
    Capital
    
    
    Stage
    
    
    TotalBalance, January 7, 2005 (inception)
    
    
    
    
    
    $
    
    
    
    
    
    
    
    $
    
    
    
    $
    
    
    
    $
    
    
    
    $
    Issuance of common stock to initial stockholders at
$0.64 per share
    
    
    
    
    
    
    
    
    
    
    338,116
    
    
    
    338
    
    
    
    216,462
    
    
    
    
    
    
    
    216,800Net loss
    
    
    
    
    
    
    
    
    
    
    
    
    
    
    
    
    
    
    
    
    
    
    (1,067,659
    )
    
    
    (1,067,659
    )Balance, December 31, 2005
    
    
    
    
    
    
    
    
    
    
    338,116
    
    
    
    338
    
    
    
    216,462
    
    
    
    (1,067,659
    )
    
    
    (850,859
    )Stock-based compensation
    
    
    
    
    
    
    
    
    
    
    114,158
    
    
    
    114
    
    
    
    43,996
    
    
    
    
    
    
    
    44,110Conversion of convertible notes and accrued interest
into Series A redeemable convertible preferred stock
    
    
    3,481,645
    
    
    
    2,590,343
    
    
    
    
    
    
    
    
    
    
    
    647,587
    
    
    
    
    
    
    
    647,587Sale of Series A redeemable convertible preferred
stock at $0.93 per share, net of expenses of
$267,458
    
    
    8,064,516
    
    
    
    7,232,542
    
    
    
    
    
    
    
    
    
    
    
    
    
    
    
    
    
    
    
    Accretion of Series A redeemable convertible
preferred stock to redemption value
    
    
    
    
    
    
    340,998
    
    
    
    
    
    
    
    
    
    
    
    (340,998
    )
    
    
    
    
    
    
    (340,998
    )Net loss
    
    
    
    
    
    
    
    
    
    
    
    
    
    
    
    
    
    
    
    
    
    
    (5,215,756
    )
    
    
    (5,215,756
    )Balance, December 31, 2006
    
    
    11,546,161
    
    
    
    10,163,883
    
    
    
    452,274
    
    
    
    452
    
    
    
    567,047
    
    
    
    (6,283,415
    )
    
    
    (5,715,916
    )Stock-based compensation
    
    
    
    
    
    
    
    
    
    
    
    
    
    
    
    
    
    
    59,205
    
    
    
    
    
    
    
    59,205Sale of Series A redeemable convertible preferred
stock at $0.93 per share, net of expenses of $20,272
    
    
    5,376,345
    
    
    
    4,979,729
    
    
    
    
    
    
    
    
    
    
    
    
    
    
    
    
    
    
    
    Accretion of Series A redeemable convertible
preferred stock to redemption value
    
    
    
    
    
    
    1,126,265
    
    
    
    
    
    
    
    
    
    
    
    (626,252
    )
    
    
    (500,013
    )
    
    
    (1,126,265
    )Net loss
    
    
    
    
    
    
    
    
    
    
    
    
    
    
    
    
    
    
    
    
    
    
    (9,675,073
    )
    
    
    (9,675,073
    )Balance, December 31, 2007
    
    
    16,922,506
    
    
    
    16,269,877
    
    
    
    452,274
    
    
    
    452
    
    
    
    
    
    
    
    (16,458,501
    )
    
    
    (16,458,049
    )Stock-based compensation
    
    
    
    
    
    
    
    
    
    
    
    
    
    
    
    
    
    
    158,176
    
    
    
    
    
    
    
    158,176Exercise of stock options
    
    
    
    
    
    
    
    
    
    
    155
    
    
    
    
    
    
    
    225
    
    
    
    
    
    
    
    225Sale of Series A redeemable convertible preferred
stock at $0.93 per share
    
    
    2,688,171
    
    
    
    2,499,999
    
    
    
    
    
    
    
    
    
    
    
    
    
    
    
    
    
    
    
    Sale of Series B redeemable convertible preferred
stock at $0.93 per share, net of expenses of
$304,368
    
    
    22,594,385
    
    
    
    20,708,410
    
    
    
    
    
    
    
    
    
    
    
    
    
    
    
    
    
    
    
    Accretion of Series A and Series B redeemable
convertible preferred stock to redemption value
    
    
    
    
    
    
    2,330,344
    
    
    
    
    
    
    
    
    
    
    
    (158,401
    )
    
    
    (2,171,943
    )
    
    
    (2,330,344
    )Net loss
    
    
    
    
    
    
    
    
    
    
    
    
    
    
    
    
    
    
    
    
    
    
    (17,511,203
    )
    
    
    (17,511,203
    )Balance, December 31, 2008
    
    
    42,205,062
    
    
    
    41,808,630
    
    
    
    452,429
    
    
    
    452
    
    
    
    
    
    
    
    (36,141,647
    )
    
    
    (36,141,195
    )
  65




---



##### Table of Contents



Stockholders Equity (Deficit)DeficitAccumulatedRedeemable Convertible
    
    
    
    
    
    
    
    
    
    
    Additional
    
    
    During thePreferred Stock
    
    
    Common Stock
    
    
    Paid-in
    
    
    DevelopmentShares
    
    
    Amount
    
    
    Shares
    
    
    Amount
    
    
    Capital
    
    
    Stage
    
    
    TotalStock-based compensation
    
    
    
    
    
    $
    
    
    
    
    
    
    
    $
    
    
    
    $
    319,055
    
    
    $
    
    
    
    $
    319,055Forfeiture of restricted stock
    
    
    
    
    
    
    
    
    
    
    (61,753
    )
    
    
    (62
    )
    
    
    62
    
    
    
    
    
    
    
    Sale of Series B redeemable convertible preferred
stock at $0.93 per share, net of expenses of $16,538
    
    
    8,786,952
    
    
    
    8,155,327
    
    
    
    
    
    
    
    
    
    
    
    
    
    
    
    
    
    
    
    Conversion of convertible notes and accrued interest
into Series B redeemable convertible preferred stock
    
    
    2,104,326
    
    
    
    1,957,023
    
    
    
    
    
    
    
    
    
    
    
    
    
    
    
    
    
    
    
    Beneficial conversion feature related to the
convertible note and warrant agreement
    
    
    
    
    
    
    
    
    
    
    
    
    
    
    
    
    
    
    556,042
    
    
    
    
    
    
    
    556,042Accretion of Series A and Series B redeemable
convertible preferred stock to redemption value
    
    
    
    
    
    
    3,617,211
    
    
    
    
    
    
    
    
    
    
    
    (875,159
    )
    
    
    (2,742,052
    )
    
    
    (3,617,211
    )Net loss
    
    
    
    
    
    
    
    
    
    
    
    
    
    
    
    
    
    
    
    
    
    
    (15,590,312
    )
    
    
    (15,590,312
    )Balance, December 31, 2009
    
    
    53,096,340
    
    
    
    55,538,191
    
    
    
    390,676
    
    
    
    390
    
    
    
    
    
    
    
    (54,474,011
    )
    
    
    (54,473,621
    )Stock-based compensation
    
    
    
    
    
    
    
    
    
    
    
    
    
    
    
    
    
    
    543,350
    
    
    
    
    
    
    
    543,350Exercise of stock options
    
    
    
    
    
    
    
    
    
    
    4,878
    
    
    
    5
    
    
    
    7,566
    
    
    
    
    
    
    
    7,571Accretion of Series A and Series B redeemable
convertible preferred stock to redemption value
    
    
    
    
    
    
    2,533,495
    
    
    
    
    
    
    
    
    
    
    
    (1,566,961
    )
    
    
    (966,534
    )
    
    
    (2,533,495
    )Conversion of preferred stock including accrued
dividends, into common stock
    
    
    (53,096,340
    )
    
    
    (58,071,686
    )
    
    
    7,861,785
    
    
    
    7,862
    
    
    
    58,063,824
    
    
    
    
    
    
    
    58,071,686Sale of common stock net of expenses of $7,028,009
    
    
    
    
    
    
    
    
    
    
    5,000,000
    
    
    
    5,000
    
    
    
    42,966,991
    
    
    
    
    
    
    
    42,971,991Conversion of convertible notes and accrued interest
into common stock
    
    
    
    
    
    
    
    
    
    
    1,292,122
    
    
    
    1,292
    
    
    
    10,335,717
    
    
    
    
    
    
    
    10,337,009Beneficial conversion feature related to convertible
notes and warrant agreements
    
    
    
    
    
    
    
    
    
    
    
    
    
    
    
    
    
    
    2,583,617
    
    
    
    
    
    
    
    2,583,617Reclassification of warrants to purchase common stock
    
    
    
    
    
    
    
    
    
    
    
    
    
    
    
    
    
    
    1,112,819
    
    
    
    
    
    
    
    1,112,819Net loss
    
    
    
    
    
    
    
    
    
    
    
    
    
    
    
    
    
    
    
    
    
    
    (24,355,787
    )
    
    
    (24,355,787
    )Balance, December 31, 2010
    
    
    
    
    
    $
    
    
    
    
    14,549,461
    
    
    $
    14,549
    
    
    $
    114,046,923
    
    
    $
    (79,796,332
    )
    
    $
    34,265,140
   66




---



##### Table of Contents



NUPATHE INC.
(A Development-Stage Company)
 
 Statements of Cash Flows
 Period fromJanuary 7, 2005Year Ended December 31,
    
    
    (inception) through2010
    
    
    2009
    
    
    2008
    
    
    December 31, 2010Cash flows from operating activities:Net loss
    
    $
    (24,355,787
    )
    
    $
    (15,590,312
    )
    
    $
    (17,511,203
    )
    
    $
    (73,415,790
    )Adjustments to reconcile net loss to net cash used in operating activities:Depreciation expense
    
    
    46,649
    
    
    
    57,383
    
    
    
    48,197
    
    
    
    177,474Loss on asset disposal
    
    
    
    
    
    
    23,508
    
    
    
    
    
    
    
    23,508Acquired in-process research and development
    
    
    
    
    
    
    
    
    
    
    5,500,000
    
    
    
    5,500,000Stock-based compensation
    
    
    543,350
    
    
    
    319,055
    
    
    
    158,176
    
    
    
    1,132,696Noncash interest expense
    
    
    3,336,744
    
    
    
    1,154,486
    
    
    
    49,503
    
    
    
    5,225,136Changes in operating assets and liabilities:Prepaid expenses and other assets
    
    
    299,879
    
    
    
    301,090
    
    
    
    (702,692
    )
    
    
    (532,577
    )Accounts payable
    
    
    (265,929
    )
    
    
    543,684
    
    
    
    (11,149
    )
    
    
    1,198,177Accrued expenses
    
    
    1,991,746
    
    
    
    (376,524
    )
    
    
    195,537
    
    
    
    3,151,942Net cash used in operating activities
    
    
    (18,403,348
    )
    
    
    (13,567,630
    )
    
    
    (12,273,631
    )
    
    
    (57,539,434
    )Cash flows from investing activities:Purchase of in-process research and development
    
    
    
    
    
    
    
    
    
    
    (5,500,000
    )
    
    
    (5,500,000
    )Payments under equipment funding agreement
    
    
    (3,410,315
    )
    
    
    
    
    
    
    
    
    
    
    (3,410,315
    )Purchases of property and equipment
    
    
    (74,287
    )
    
    
    (28,792
    )
    
    
    (126,677
    )
    
    
    (299,247
    )Net cash used in investing activities
    
    
    (3,484,602
    )
    
    
    (28,792
    )
    
    
    (5,626,677
    )
    
    
    (9,209,562
    )Cash flows from financing activities:Proceeds from issuance of debt
    
    
    5,000,000
    
    
    
    
    
    
    
    100,749
    
    
    
    7,608,741Proceeds from convertible notes
    
    
    10,062,500
    
    
    
    1,934,183
    
    
    
    
    
    
    
    14,466,683Payment of debt issuance costs
    
    
    (174,324
    )
    
    
    
    
    
    
    
    
    
    
    (248,358
    )Repayment of debt
    
    
    (988,030
    )
    
    
    (934,975
    )
    
    
    (870,879
    )
    
    
    (2,923,532
    )Proceeds from sale of preferred stock, net
    
    
    
    
    
    
    8,155,327
    
    
    
    23,208,409
    
    
    
    43,576,007Proceeds from sale of common stock, net
    
    
    42,979,562
    
    
    
    
    
    
    
    225
    
    
    
    43,187,787Net cash provided by financing activities
    
    
    56,879,708
    
    
    
    9,154,535
    
    
    
    22,438,504
    
    
    
    105,667,328Net increase (decrease) in cash and cash equivalents
    
    
    34,991,758
    
    
    
    (4,441,887
    )
    
    
    4,538,196
    
    
    
    38,918,332Cash and cash equivalents, beginning of period
    
    
    3,926,574
    
    
    
    8,368,461
    
    
    
    3,830,265
    
    
    
    Cash and cash equivalents, end of period
    
    $
    38,918,332
    
    
    $
    3,926,574
    
    
    $
    8,368,461
    
    
    $
    38,918,332Supplemental cash flow disclosures:Noncash investing and financing activities:Conversion of note principal and accrued interest to redeemable convertible preferred stock
    
    $
    
    
    
    $
    1,957,023
    
    
    $
    
    
    
    $
    4,547,366Conversion of note principal and accrued interest to common stock
    
    
    10,337,009
    
    
    
    
    
    
    
    
    
    
    
    10,337,009Conversion of preferred stock plus accrued dividends to common stock
    
    
    58,071,686
    
    
    
    
    
    
    
    
    
    
    
    58,071,686Reclassification of warrant liability
    
    
    1,112,819
    
    
    
    
    
    
    
    
    
    
    
    1,112,819Accretion of redeemable convertible preferred stock
    
    
    2,533,495
    
    
    
    3,617,211
    
    
    
    2,330,344
    
    
    
    9,948,311Cash paid for interest
    
    
    380,942
    
    
    
    173,580
    
    
    
    236,078
    
    
    
    983,747
   67




---



##### Table of Contents



NUPATHE INC.
(A Development-Stage Company)
 
 Notes to Financial Statements
 (1) Background
  (2) Development-Stage Risks and Liquidity
   (3) Summary of Significant Accounting Policies
 (a) Use of Estimates
  (b) Fair Value of Financial Instruments
   
    
    Level 1:Unadjusted quoted prices in active markets that are accessible at the
measurement date for identical, unrestricted assets or liabilities;
 
    
    Level 2:Quoted prices in markets that are not active, or inputs which are observable,
either directly or indirectly, for substantially the full term of the asset or liabilities;
or
 
    
    Level 3:Prices or valuation techniques that require inputs that are both significant to
the fair value measurement and unobservable (i.e., supported by little or no market
activity).
  68




---



##### Table of Contents



Fair Value Measurement at Reporting Date UsingQuoted Pricesin Active
    
    
    SignificantMarkets for
    
    
    Other
    
    
    SignificantIdentical
    
    
    Observable
    
    
    UnobservableAssets
    
    
    Inputs
    
    
    Inputs(Level 1)
    
    
    (Level 2)
    
    
    (Level 3)
    
    
    TotalAt December 31, 2010AssetsCash equivalents
    
    $
    38,770,210
    
    
    $
    
    
    
    $
    
    
    
    $
    38,770,210At December 31, 2009AssetsCash equivalents
    
    $
    3,654,831
    
    
    $
    
    
    
    $
    
    
    
    $
    3,654,831LiabilitiesWarrant liability
    
    $
    
    
    
    $
    
    
    
    $
    626,492
    
    
    $
    626,492
  WarrantLiabilityBalance at January 1, 2009
    
    $
    102,354Issuance of additional warrants
    
    
    556,042Change in fair value of warrant liability
    
    
    (31,904
    )Balance at December 31, 2009
    
    
    626,492Issuance of additional warrants
    
    
    204,224Change in fair value of warrant liability
    
    
    282,103Reclassification of warrant liability to stockholders equity
    
    
    (1,112,819
    )Balance at December 31, 2010
    
    $
    
  (c) Cash and Cash Equivalents
  (d) Property and Equipment
   69




---



##### Table of Contents



(e) Government Grants
  (f) Research and Development and In-Process Research and Development
  (g) Income Taxes
   70




---



##### Table of Contents



(h) Stock-Based Compensation
   .
  (i) Net Loss Per Common Share
   December 31,2010
    
    
    2009
    
    
    2008Shares of redeemable convertible preferred stock
    
    
    
    
    
    
    6,624,704
    
    
    
    5,265,825Shares issuable pursuant to redeemable convertible preferred stock accretion
    
    
    
    
    
    
    912,285
    
    
    
    451,233Shares underlying outstanding options to purchase common stock
    
    
    1,415,106
    
    
    
    950,693
    
    
    
    898,790Shares of unvested restricted stock
    
    
    
    
    
    
    8,887
    
    
    
    70,640Shares underlying outstanding warrants to purchase stock *
    
    
    140,520
    
    
    
    108,659
    
    
    
    16,769
 *
    
    The 2009 and 2008 amounts represent warrants to purchase preferred stock, the 2010 amount
represents warrants to purchase common stock.
  71




---



##### Table of Contents



(j) Segment Information
  (k) Recently Issued Accounting Pronouncements
  (l) Reverse Stock Split Ratio
  (4) Property and Equipment
  December 31,2010
    
    
    2009Computer equipment and software
    
    $
    179,126
    
    
    $
    109,414Office equipment and furniture
    
    
    3,086
    
    
    
    3,086Lab equipment
    
    
    19,623
    
    
    
    19,623Leasehold improvements
    
    
    42,813
    
    
    
    38,238244,648
    
    
    
    170,361Less accumulated depreciation and amortization
    
    
    (146,382
    )
    
    
    (99,733
    )$
    98,266
    
    
    $
    70,628
  (5) Accrued Expenses
  December 31,2010
    
    
    2009Accrued compensation and benefits
    
    $
    1,047,542
    
    
    $
    504,091Accrued professional fees
    
    
    306,816
    
    
    
    112,301Accrued research and development expenses
    
    
    1,502,330
    
    
    
    238,401Accrued interest and other
    
    
    216,329
    
    
    
    181,033$
    3,073,017
    
    
    $
    1,035,826
  72




---



##### Table of Contents



(6) Debt
 (a) Convertible Notes
   Date ofIssuanceDecember 31,
    
    
    (August 20,2009
    
    
    2009)Fair value
    
    $
    526,828
    
    
    $
    556,042Expected dividend yield
    
    
    
    %
    
    
    
    %Expected volatility
    
    
    87.83
    %
    
    
    95.50
    %Risk-free interest rate
    
    
    3.26
    %
    
    
    2.60
    %Remaining contractual term
    
    6.6 years
    
    
    7 years
   (b) Credit Facilities and Vendor Debt
   73




---



##### Table of Contents



December 31,2009Fair value
    
    $
    99,664Expected dividend yield
    
    
    
    %Expected volatility
    
    
    89.17
    %Risk-free interest rate
    
    
    3.43
    %Remaining contractual term
    
    7.25 years
   (7) Capital Structure
 (a) Initial Public Offering
  (b) Redeemable Convertible Preferred Stock
  (c) Warrants
  Number ofShares
    
    
    Exercise Price
    
    
    ExpirationCommon Stock
    
    
    140,520
    
    
    $
    7.45
    
    
    2016 through 2020
   74




---



##### Table of Contents



(8) Stock-Based Compensation
   Year Ended December 31,2010
    
    
    2009
    
    
    2008Stock options:Employee
    
    $
    507,065
    
    
    $
    308,418
    
    
    $
    104,547Nonemployee
    
    
    27,751
    
    
    
    18,869
    
    
    
    9,466534,816
    
    
    
    327,287
    
    
    
    114,013Restricted stock:Employee
    
    
    8,534
    
    
    
    (8,232
    )
    
    
    44,163$
    543,350
    
    
    $
    319,055
    
    
    $
    158,176
   Year Ended December 31,2010
    
    
    2009
    
    
    2008Research and development
    
    $
    143,502
    
    
    $
    118,504
    
    
    $
    54,622Selling, general and administrative
    
    
    399,848
    
    
    
    200,551
    
    
    
    103,554$
    543,350
    
    
    $
    319,055
    
    
    $
    158,176
 Stock Options
  Year Ended December 31,2010
    
    
    2009
    
    
    2008Expected dividend yield
    
    
    
    %
    
    
    
    %
    
    
    
    %Expected volatility
    
    
    84.1
    %
    
    
    92.8
    %
    
    
    79.8
    %Risk-free interest rate
    
    
    1.9
    %
    
    
    2.2
    %
    
    
    2.9
    %Expected life
    
    6 years
    
    
    5.25 years
    
    
    6 years
  75




---



##### Table of Contents



WeightedWeighted
    
    
    AverageAverage
    
    
    Remaining
    
    
    AggregateNumber of
    
    
    Exercise
    
    
    Contractual
    
    
    IntrinsicShares
    
    
    Price
    
    
    Term in Years
    
    
    ValueOutstanding at January 1, 2008
    
    
    165,741
    
    
    $
    1.28Granted
    
    
    749,162
    
    
    
    1.92Exercised
    
    
    (155
    )
    
    
    1.44Cancelled/forfeited
    
    
    (15,958
    )
    
    
    1.52Outstanding at December 31, 2008
    
    
    898,790
    
    
    
    1.76Granted
    
    
    68,447
    
    
    
    1.92Exercised
    
    
    
    
    
    
    Cancelled/forfeited
    
    
    (16,544
    )
    
    
    1.76Outstanding at December 31, 2009
    
    
    950,693
    
    
    
    1.81Granted
    
    
    483,372
    
    
    
    8.87Exercised
    
    
    (4,878
    )
    
    
    1.55Cancelled/forfeited
    
    
    (14,081
    )
    
    
    1.76Outstanding at December 31, 2010
    
    
    1,415,106
    
    
    $
    4.22
    
    
    
    8.19
    
    
    $
    7,138,997Vested and expected to vest at December 31, 2010
    
    
    1,415,106
    
    
    $
    4.22
    
    
    
    8.19
    
    
    $
    7,138,997Exercisable at December 31, 2010
    
    
    629,902
    
    
    $
    1.76
    
    
    
    7.30
    
    
    $
    4,596,937
     Options outstanding
    
    
    Options exercisableWeighted
    
    
    
    
    
    
    Weightedaverage
    
    
    
    
    
    
    averageremaining
    
    
    
    
    
    
    remainingNumber of
    
    
    contractual
    
    
    Number of
    
    
    contractualExercise Price
    
    Options
    
    
    term (years)
    
    
    Options
    
    
    term (years)$0.80
    
    
    34,308
    
    
    
    4.55
    
    
    
    34,308
    
    
    
    4.55$0.96
    
    
    16,217
    
    
    
    5.07
    
    
    
    16,217
    
    
    
    5.07$1.44
    
    
    101,938
    
    
    
    6.22
    
    
    
    94,674
    
    
    
    6.18$1.92
    
    
    779,271
    
    
    
    7.78
    
    
    
    484,703
    
    
    
    7.79$5.93
    
    
    90,000
    
    
    
    9.77
    
    
    
    
    
    
    
    $7.22
    
    
    7,000
    
    
    
    9.94
    
    
    
    
    
    
    
    $7.88
    
    
    75,350
    
    
    
    9.69
    
    
    
    
    
    
    
    $10.00
    
    
    311,022
    
    
    
    9.60
    
    
    
    
    
    
    
    1,415,106
    
    
    
    8.19
    
    
    
    629,902
    
    
    
    7.30
  76




---



##### Table of Contents



Restricted Stock
  WeightedAverageNumber of
    
    
    Grant DateShares
    
    
    Fair ValueNonvested shares at January 1, 2008
    
    
    70,640
    
    
    $
    1.36Granted
    
    
    
    
    
    
    Vested
    
    
    
    
    
    
    Forfeited/repurchased
    
    
    
    
    
    
    Nonvested shares at December 31, 2008
    
    
    70,640
    
    
    $
    1.36Granted
    
    
    
    
    
    
    Vested
    
    
    
    
    
    
    Forfeited/repurchased
    
    
    (61,753
    )
    
    $
    1.44Nonvested shares at December 31, 2009
    
    
    8,887
    
    
    $
    0.96Granted
    
    
    
    
    
    
    Vested
    
    
    (8,887
    )
    
    $
    0.96Forfeited/repurchased
    
    
    
    
    
    
    Nonvested shares at December 31, 2010
    
    
    
    
    
    
    
 (9) Commitments
 (a) Leases
   2011
    
    $
    363,1212012
    
    
    368,2282013
    
    
    91,221$
    822,570
 (b) License Agreements
   77




---



##### Table of Contents



(c) Equipment Funding Agreement
    78




---



##### Table of Contents



(d) Employment Agreements
  (10) 401(k) Profit Sharing Plan
  (11) Related-Party Transactions
  (12) Income Taxes
   Year Ended December 31,2010
    
    
    2009
    
    
    2008Percent of pre-tax income:U.S. federal statutory income tax rate
    
    
    34.0
    %
    
    
    34.0
    %
    
    
    34.0
    %State taxes, net of federal benefit
    
    
    5.8
    
    
    
    6.5
    
    
    
    6.5Other
    
    
    (1.4
    )
    
    
    1.0
    
    
    
    3.8Change in valuation allowance
    
    
    (36.3
    )
    
    
    (40.6
    )
    
    
    (44.3
    )Effective income tax rate
    
    
    2.1
    %
    
    
    0.9
    %
    
    
    
    %
  December 31,2010
    
    
    2009Net operating loss carryforwards
    
    $
    25,702,568
    
    
    $
    17,118,099Research and development credit
    
    
    1,627,895
    
    
    
    1,272,271Depreciation and amortization
    
    
    1,899,425
    
    
    
    2,014,476Capitalized start-up costs
    
    
    112,952
    
    
    
    141,190Other temporary differences
    
    
    414,257
    
    
    
    182,720Gross deferred tax asset
    
    
    29,757,097
    
    
    
    20,728,756Deferred tax assets valuation allowance
    
    
    (29,757,097
    )
    
    
    (20,728,756
    )$
    
    
    
    $
    
  79




---



##### Table of Contents



Amount
    
    
    ExpirationFederal net operating losses
    
    $
    63,317,112
    
    
    
    2026  2030State net operating losses
    
    
    63,317,112
    
    
    
    2026  2030Research and development credits
    
    
    1,627,895
    
    
    
    2025  2030
     80




---



##### Table of Contents



(13) Quarterly Financial Information


(unaudited)
  2010 ResultsFirst quarter
    
    
    Second quarter
    
    
    Third quarter
    
    
    Fourth quarter
    
    
    TotalGrant revenue
    
    $
    
    
    
    $
    
    
    
    $
    
    
    
    $
    649,959
    
    
    $
    649,959Operating expenses
    
    
    4,262,935
    
    
    
    4,213,153
    
    
    
    6,510,958
    
    
    
    6,848,439
    
    
    
    21,835,485Loss from operations
    
    
    (4,262,935
    )
    
    
    (4,213,153
    )
    
    
    (6,510,958
    )
    
    
    (6,198,480
    )
    
    
    (21,185,526
    )Interest expense, net
    
    
    (10,487
    )
    
    
    (1,431,301
    )
    
    
    (2,073,688
    )
    
    
    (155,173
    )
    
    
    (3,670,649
    )Loss before tax benefit
    
    
    (4,273,422
    )
    
    
    (5,644,454
    )
    
    
    (8,584,646
    )
    
    
    (6,353,653
    )
    
    
    (24,856,175
    )Income tax benefit
    
    
    320,381
    
    
    
    
    
    
    
    
    
    
    
    180,007
    
    
    
    500,388Net loss
    
    
    (3,953,041
    )
    
    
    (5,644,454
    )
    
    
    (8,584,646
    )
    
    
    (6,173,646
    )
    
    
    (24,355,787
    )Accretion of redeemable convertible preferred stock
    
    
    (1,033,399
    )
    
    
    (1,033,399
    )
    
    
    (466,697
    )
    
    
    
    
    
    
    (2,533,495
    )Net loss available to common stockholders
    
    $
    (4,986,440
    )
    
    $
    (6,677,853
    )
    
    $
    (9,051,343
    )
    
    $
    (6,173,646
    )
    
    $
    (26,889,282
    )Basic and diluted net loss per common share
    
    $
    (13.06
    )
    
    $
    (17.42
    )
    
    $
    (1.01
    )
    
    $
    (0.42
    )
    
    $
    (4.39
    )Weighted average basic and diluted common shares outstanding
    
    
    381,842
    
    
    
    383,368
    
    
    
    9,003,135
    
    
    
    14,548,851
    
    
    
    6,126,123
 2009 ResultsFirst quarter
    
    
    Second quarter
    
    
    Third quarter
    
    
    Fourth quarter
    
    
    TotalOperating expenses
    
    $
    3,792,190
    
    
    $
    3,952,711
    
    
    $
    3,445,573
    
    
    $
    3,261,282
    
    
    $
    14,451,756Interest expense, net
    
    
    (37,107
    )
    
    
    (44,269
    )
    
    
    (1,204,656
    )
    
    
    (3,536
    )
    
    
    (1,289,568
    )Loss before tax benefit
    
    
    (3,829,297
    )
    
    
    (3,996,980
    )
    
    
    (4,650,229
    )
    
    
    (3,264,818
    )
    
    
    (15,741,324
    )Income tax benefit
    
    
    151,012
    
    
    
    
    
    
    
    
    
    
    
    
    
    
    
    151,012Net loss
    
    
    (3,678,285
    )
    
    
    (3,996,980
    )
    
    
    (4,650,229
    )
    
    
    (3,264,818
    )
    
    
    (15,590,312
    )Accretion of redeemable convertible preferred stock
    
    
    (829,766
    )
    
    
    (829,766
    )
    
    
    (924,280
    )
    
    
    (1,033,399
    )
    
    
    (3,617,211
    )Net loss available to common stockholders
    
    $
    (4,508,051
    )
    
    $
    (4,826,746
    )
    
    $
    (5,574,509
    )
    
    $
    (4,298,217
    )
    
    $
    (19,207,523
    )Basic and diluted net loss per common share
    
    $
    (11.81
    )
    
    $
    (12.64
    )
    
    $
    (14.60
    )
    
    $
    (11.26
    )
    
    $
    (50.31
    )Weighted average basic and diluted common shares outstanding
    
    
    381,789
    
    
    
    381,789
    
    
    
    381,789
    
    
    
    381,789
    
    
    
    381,789
  81




---



##### Table of Contents



ITEM 9.
    
    CHANGES IN AND DISAGREEMENTS WITH ACCOUNTANTS ON ACCOUNTING AND FINANCIAL DISCLOSURE
  
 ITEM 9A.
    
    CONTROLS AND PROCEDURES
 Evaluation of Disclosure Controls and Procedures
  Managements Report on Internal Control Over Financial Reporting
  Changes to Internal Controls Over Financial Reporting
  
 ITEM 9B.
    
    OTHER INFORMATION
   82




---



##### Table of Contents



PART III
 
 ITEM 10.
    
    DIRECTORS, EXECUTIVE OFFICERS AND CORPORATE GOVERNANCE
     
 ITEM 11.
    
    EXECUTIVE COMPENSATION
  
 ITEM 12.
    
    SECURITY OWNERSHIP OF CERTAIN BENEFICIAL OWNERS AND MANAGEMENT AND RELATED STOCKHOLDER
MATTERS
  
 ITEM 13.
    
    CERTAIN RELATIONSHIPS AND RELATED TRANSACTIONS, AND DIRECTOR INDEPENDENCE
  
 ITEM 14.
    
    PRINCIPAL ACCOUNTANT FEES AND SERVICES
   83




---



##### Table of Contents



PART IV
 
 ITEM 15.  EXHIBITS, FINANCIAL STATEMENT SCHEDULES
 Financial Statements
 Report of Independent Registered Public Accounting Firm
    
    
    62Balance Sheets
    
    
    63Statements of Operations
    
    
    64Statements of Redeemable Convertible Preferred Stock and Stockholders Equity (Deficit)
    
    
    65Statements of Cash Flows
    
    
    67Notes to Financial Statements
    
    
    68
 Financial Statement Schedules
 Exhibits
  84




---



##### Table of Contents



SIGNATURES
  NUPATHE INC.Date: March 18, 2011
    By:
    /s/ Jane H. HollingsworthJane H. HollingsworthChief Executive Officer POWER OF ATTORNEY
   Signature
    
    Title
    
    Date/s/ Jane H. Hollingsworth

Jane H. Hollingsworth
    
    Chief Executive
Officer and Director

(Principal Executive
Officer)
    
    March 18, 2011/s/ Keith A. Goldan

Keith A. Goldan
    
    Chief Financial Officer

(Principal Financial
and Accounting
Officer)
    
    March 18, 2011/s/ Wayne P. Yetter

Wayne P. Yetter
    
    Chairman of the Board
    
    March 18, 2011/s/ Michael Cola

Michael Cola
    
    Director
    
    March 18, 2011/s/ Jeanne Cunicelli

Jeanne Cunicelli
    
    Director
    
    March 18, 2011/s/ Michael C. Diem

Michael C. Diem, M.D.
    
    Director
    
    March 18, 2011/s/ William J. Federici

William J. Federici
    
    Director
    
    March 18, 2011/s/ Richard S. Kollender

Richard S. Kollender
    
    Director
    
    March 18, 2011/s/ Gary J. Kurtzman

Gary J. Kurtzman, M.D.
    
    Director
    
    March 18, 2011/s/ Robert P. Roche, Jr.

Robert P. Roche, Jr.
    
    Director
    
    March 18, 2011




---



##### Table of Contents



INDEX TO EXHIBITS
 Exhibit
    
    
    
    Incorporated by Reference
    
    FiledNumber
    
    Exhibit Description
    
    Form
    
    File No.
    
    
    Exhibit
    
    
    Filing Date
    
    Herewith3.1
    
    
    Restated Certificate of Incorporation of
NuPathe Inc.
    
    8-K
    
    001-34836
    
    
    3.1
    
    
    August 12, 20103.2
    
    
    Bylaws of NuPathe Inc.
    
    8-K
    
    001-34836
    
    
    3.2
    
    
    August 12, 20104.1
    
    
    Amended and Restated Investor Rights Agreement,
dated as of July 8, 2008, as amended on July
20, 2010 and August 4, 2010
    
    S-1/A
    
    333-166825
    
    
    4.1
    
    
    August 5, 20104.2
    
    
    Preferred Stock Warrant, dated as of March 29,
2007, as amended, issued to Oxford Finance
Corp.
    
    S-1/A
    
    333-166825
    
    
    4.2
    
    
    June 15, 20104.3
    
    
    Form of Warrant to Purchase Shares of Series B
Preferred Stock, as amended
    
    S-1/A
    
    333-166825
    
    
    4.3
    
    
    June 15, 20104.4
    
    
    Series B Preferred Stock Warrant, dated May 13,
2010, issued to MidCap Funding III, LLC
    
    S-1/A
    
    333-166825
    
    
    4.4
    
    
    June 15, 20104.5
    
    
    Series B Preferred Stock Warrant, dated May 13,
2010, issued to Silicon Valley Bank
    
    S-1/A
    
    333-166825
    
    
    4.5
    
    
    June 15, 201010.1
    *
    
    Patent License Agreement, effective as of
July 1, 2006, as amended, between NuPathe Inc.
and The Trustees of the University of
Pennsylvania
    
    S-1/A
    
    333-166825
    
    
    10.1
    
    
    June 15, 201010.2
    *
    
    Development and License Agreement, dated
September 14, 2007, as amended, between NuPathe
Inc. and LTS Lohmann Therapie-Systeme AG
    
    S-1/A
    
    333-166825
    
    
    10.2
    
    
    July 27, 201010.3
    
    
    Asset Purchase and License Agreement, dated
July 8, 2008, between NuPathe Inc. and Travanti
Pharma Inc.
    
    S-1/A
    
    333-166825
    
    
    10.3
    
    
    June 15, 201010.4
    *
    
    Feasibility Evaluation Agreement, dated
March 19, 2007, as amended, between NuPathe
Inc. and SurModics Pharmaceuticals, Inc. (f/k/a
Brookwood Pharmaceuticals, Inc.)
    
    S-1/A
    
    333-166825
    
    
    10.4
    
    
    July 27, 201010.5
    *
    
    License Agreement, dated September 23, 2009,
between NuPathe Inc. and SurModics
Pharmaceuticals, Inc. (f/k/a Brookwood
Pharmaceuticals, Inc.)
    
    S-1/A
    
    333-166825
    
    
    10.5
    
    
    July 27, 201010.6
    
    
    Secured Subordinated Convertible Note and
Warrant Purchase Agreement, dated April 9,
2010, between NuPathe Inc. and the Purchasers
named therein
    
    S-1/A
    
    333-166825
    
    
    10.6
    
    
    June 15, 201010.7
    
    
    Loan and Security Agreement, effective as of
May 13, 2010, by and among MidCap Funding III,
LLC, Silicon Valley Bank and NuPathe Inc.
    
    S-1/A
    
    333-166825
    
    
    10.7
    
    
    June 15, 201010.8
    
    
    Secured Promissory Note, dated May 13, 2010,
made by NuPathe Inc. in favor of MidCap Funding
III, LLC
    
    S-1/A
    
    333-166825
    
    
    10.8
    
    
    June 15, 2010




---



##### Table of Contents



Exhibit
    
    
    
    Incorporated by Reference
    
    FiledNumber
    
    Exhibit Description
    
    Form
    
    File No.
    
    
    Exhibit
    
    
    Filing Date
    
    Herewith10.9
    
    
    Secured Promissory Note, dated May 13, 2010,
made by NuPathe Inc. in favor of Silicon Valley
Bank
    
    S-1/A
    
    333-166825
    
    
    10.9
    
    
    June 15, 201010.10
    *
    
    Equipment Funding Agreement, dated June 1,
2010, between NuPathe Inc. and LTS Lohmann
Therapie-Systeme AG
    
    S-1/A
    
    333-166825
    
    
    10.11
    
    
    July 27, 201010.11
    
    
    Office Space Lease, dated January 10, 2008,
between NuPathe Inc. and Washington Street
Associates II, L.P.
    
    S-1/A
    
    333-166825
    
    
    10.10
    
    
    June 15, 201010.12
    
    
    First Amendment to Office
Space Lease, dated November 1, 2010, between NuPathe Inc. and
Washington Street Associates II, L.P.
    
    
    
    
    
    
    
    
    
    
    
    X10.13
    #
    
    Amended and Restated 2005 Equity Compensation
Plan, as amended, including forms of Incentive
Stock Option Grant, Nonqualified Stock Option
Grant and Restricted Stock Grant Agreement
thereunder
    
    S-1/A
    
    333-166825
    
    
    10.12
    
    
    June 15, 201010.14
    #
    
    NuPathe Inc. 2010 Omnibus Incentive
Compensation Plan
    
    10-Q
    
    001-34836
    
    
    10.1
    
    
    November 12, 201010.15
    #
    
    Form of Incentive Stock Option Grant Agreement
for awards under NuPathe Inc. 2010 Omnibus
Incentive Compensation Plan
    
    10-Q
    
    001-34836
    
    
    10.2
    
    
    November 12, 201010.16
    #
    
    Form of Nonqualified Stock Option Grant
Agreement for awards under NuPathe Inc. 2010
Omnibus Incentive Compensation Plan
    
    10-Q
    
    001-34836
    
    
    10.3
    
    
    November 12, 201010.17
    #
    
    Form of Nonqualified Stock Option Grant
Agreement for awards to non-employee directors
under NuPathe Inc. 2010 Omnibus Incentive
Compensation Plan
    
    10-Q
    
    001-34836
    
    
    10.4
    
    
    November 12, 201010.18
    #
    
    Form of Restricted Stock Grant Agreement for
awards under NuPathe Inc. 2010 Omnibus
Incentive Compensation Plan
    
    10-Q
    
    001-34836
    
    
    10.5
    
    
    November 12, 201010.19
    #
    
    NuPathe Inc. 2010 Employee Stock Purchase Plan
    
    S-1/A
    
    333-166825
    
    
    10.14
    
    
    July 21, 201010.20
    #
    
    Employment Agreement between NuPathe Inc. and
Jane H. Hollingsworth
    
    S-1/A
    
    333-166825
    
    
    10.15
    
    
    July 9, 201010.21
    #
    
    Employment Agreement between NuPathe Inc. and
Terri B. Sebree
    
    S-1/A
    
    333-166825
    
    
    10.16
    
    
    July 9, 201010.22
    #
    
    Employment Agreement between NuPathe Inc. and
Keith A. Goldan
    
    S-1/A
    
    333-166825
    
    
    10.17
    
    
    July 9, 201010.23
    #
    
    Employment Agreement between NuPathe Inc. and
Gerald W. McLaughlin
    
    S-1/A
    
    333-166825
    
    
    10.18
    
    
    July 9, 201010.24
    #
    
    Employment Agreement between NuPathe Inc. and
Ezra H. Felker
    
    S-1/A
    
    333-166825
    
    
    10.19
    
    
    July 9, 201010.25
    #
    
    Employment Agreement, dated October 7, 2010, by
and between NuPathe Inc. and Michael F. Marino
    
    10-Q
    
    001-34836
    
    
    10.8
    
    
    November 12, 201010.26
    #
    
    NuPathe Inc. Non-employee Director Compensation
Policy
    
    
    
    
    
    
    
    
    
    
    
    X




---



##### Table of Contents



Exhibit
    
    
    
    Incorporated by Reference
    
    FiledNumber
    
    Exhibit Description
    
    Form
    
    File No.
    
    
    Exhibit
    
    
    Filing Date
    
    Herewith10.27
    #
    
    Form of Director Indemnification Agreement
    
    S-1/A
    
    333-166825
    
    
    10.20
    
    
    July 9, 201010.28
    #
    
    List of current directors with a Director
Indemnification Agreement in the form provided
as Exhibit 10.27
    
    
    
    
    
    
    
    
    
    
    
    X10.29
    
    
    License Agreement, dated December 1, 2010
between NuPathe Inc. and Washington Street Associates II, L.P.
    
    
    
    
    
    
    
    
    
    
    
    X23.1
    
    
    Consent of KPMG LLP, independent registered
public accounting firm
    
    
    
    
    
    
    
    
    
    
    
    X24.1
    
    
    Power of Attorney (included in the signature
page to this Form 10-K)
    
    
    
    
    
    
    
    
    
    
    
    X31.1
    
    
    Certification of Chief Executive Officer
pursuant to Rule 13a-14 (a) under the
Securities Exchange Act of 1934, as adopted
pursuant to Section 302 of the Sarbanes-Oxley
Act of 2002
    
    
    
    
    
    
    
    
    
    
    
    X31.2
    
    
    Certification of Chief Financial Officer
pursuant to Rule 13a-14(a) under the Securities
Exchange Act of 1934, as adopted pursuant to
Section 302 of the Sarbanes-Oxley Act of 2002
    
    
    
    
    
    
    
    
    
    
    
    X32.1
    
    
    Certification by Chief Executive Officer and
Chief Financial Officer pursuant to 18 U.S.C.
Section 1350, as adopted pursuant to Section
906 of the Sarbanes-Oxley Act of 2002
    
    
    
    
    
    
    
    
    
    
    
    
 
 *
    
    Certain information in this exhibit has been omitted pursuant to an Order Granting Confidential
Treatment issued by the Securities and Exchange Commission.#
    
    Indicates management contract or compensatory plan or arrangement.
    
    Furnished herewith.